id|nct_id|outcome_type|title|description|time_frame|population|anticipated_posting_date|anticipated_posting_month_year|units|units_analyzed|dispersion_type|param_type
1303706|NCT03551743|Secondary|Andexanet Total Volume of Distribution (Vss)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.||||L||Standard Deviation|Mean
1303707|NCT03551743|Secondary|Andexanet Total Systemic Clearance (CL)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||L/hr||Standard Deviation|Mean
1303708|NCT03551743|Secondary|Andexanet Apparent Terminal Elimination Half-life (t1/2)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration–time curve.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||hr||Standard Deviation|Mean
1303709|NCT03551743|Secondary|Andexanet Time of Maximum Observed Plasma Concentration (Tmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||hr||Full Range|Median
1303710|NCT03551743|Secondary|Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||ng*hr/mL||Standard Deviation|Mean
1303711|NCT03551743|Secondary|Andexanet Maximum Observed Plasma Concentration (Cmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Maximum observed plasma concentration was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||ng/mL||Standard Deviation|Mean
1303712|NCT03551743|Secondary|Efficacy: Percent Change From Baseline in Unbound Edoxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration|Unbound edoxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for edoxaban was determined by a rapid equilibrium dialysis method followed by Liquid chromatography- Mass Spectrometry.|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received edoxaban were included in the edoxaban pharmacokinetics (PK) analysis|||Percent change in unbound edoxaban conce||Standard Deviation|Mean
1303713|NCT03551743|Secondary|Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration|Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the PD analysis|||Percent change in thrombin generation||Standard Deviation|Mean
1303714|NCT03551743|Primary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration|Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis|||Percent change in anti-fXa activity||Standard Deviation|Mean
1303715|NCT03551730|Secondary|Andexanet Total Volume of Distribution (Vss)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||L||Standard Deviation|Mean
1303716|NCT03551730|Secondary|Andexanet Total Systemic Clearance (CL)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||L/hr||Standard Deviation|Mean
1303717|NCT03551730|Secondary|Andexanet Apparent Terminal Elimination Half-life (t1/2)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay.t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration–time curve.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||hr||Standard Deviation|Mean
1303718|NCT03551730|Secondary|Andexanet Time of Maximum Observed Plasma Concentration (Tmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||hr||Full Range|Median
1303732|NCT03496987|Secondary|Laterality of Effusion|Laterality of effusion (left or right)|<20 minutes||||Participants|||Count of Participants
1304486|NCT03020537|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
1303719|NCT03551730|Secondary|Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||ng*hr/mL||Standard Deviation|Mean
1303720|NCT03551730|Secondary|Andexanet Maximum Observed Plasma Concentration (Cmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet pharmacokinetics (PK) analysis|||ng/mL||Standard Deviation|Mean
1303721|NCT03551730|Secondary|Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration|Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the PD analysis|||Percent change in thrombin generation||Standard Deviation|Mean
1303722|NCT03551730|Primary|Efficacy:Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration Activity|Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis|||Percent change in anti-fXa activity||Standard Deviation|Mean
1303723|NCT03546192|Primary|Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance|Solicited reactions listed in the CHMP note for guidance included: injection site induration >= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature > 38.0°C for at least one day, malaise, and shivering.|Within 3 days after vaccination|Analysis was performed on the safety analysis set.|||Participants|||Count of Participants
1303724|NCT03546192|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions|A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: >=25 mm to <= 50 mm, Grade 2: >=51 to <=100 mm, Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius (°C) to <=38.4°C, Grade 2: >=38.5°C to <=38.9 °C, Grade 3: >= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.|Within 7 days after vaccination|Analysis was performed on the safety analysis set.|||Participants|||Count of Participants
1303725|NCT03546192|Primary|Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and a post-vaccination titer >= 40 (1/dil). Significant increase was defined as a pre-vaccination titer >= 10 (1/dil) and >= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.|21 days post-vaccination|Analysis was performed on the Immunogenicity analysis set.|||Participants|||Count of Participants
1303726|NCT03546192|Primary|Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.|Day 0 (pre-vaccination), Day 21 (Post-vaccination)|Analysis was performed on the Immunogenicity analysis set.|||ratio||95% Confidence Interval|Number
1303727|NCT03546192|Primary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)|Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Analysis was performed on the Immunogenicity analysis set.|||Titers (1/dilutions [dil])||95% Confidence Interval|Geometric Mean
1303728|NCT03546192|Primary|Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)|Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer >=40 (1/dilution [dil]) at pre-vaccination and post-vaccination.|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Immunogenicity analysis set included all participants who received one dose of study medication, had pre-and post-vaccination titers available and had not received vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.|||Participants|||Count of Participants
1303729|NCT03509766|Secondary|Skin Prick Techniques/Methodology Ratio|Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.|15 minutes|All 24 subjects received DuoTip II with both 1mg/ml and 6mg/ml histamine. This 24 vs 24 SPT in 24 total subjects.|||ratio||Standard Deviation|Mean
1303730|NCT03509766|Primary|Sensitivity|Sensitivity is calculated by dividing the true positive wheals divided by true positives plus false negatives and multiplying by 100. For example one false negative out of 24 tests equals a sensitivity of 95.8%.|15 minutes||||percentage of tests true positive|||Number
1303731|NCT03509766|Primary|Wheal Response|Compare Wheal response among devices using 1mm precision. SPT test will be read at 15 min time point. The maximum wheal diameter will be recorded for each of ten skin prick devices. 3mm (and 2mm above negative control) qualify as a positive test.|15 minutes||||mm||Standard Deviation|Mean
1303733|NCT03496987|Secondary|Volume of Effusion|Volume of effusion drained (in mL)|<20 minutes|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||milliters||Standard Deviation|Mean
1303734|NCT03496987|Secondary|Etiology of Effusion|Clinical etiology of effusion|<7 days|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||Participants|||Count of Participants
1303735|NCT03496987|Secondary|Number of Patients Who Had a Complication as a Result of the Procedure|Any complications that occur as a direct result of the procedure. We tracked patients for 7 days after the procedure to capture any complications (which is typical clinical practice)|<7 days|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||Participants|||Count of Participants
1303736|NCT03496987|Secondary|Number of Patients Who Had an Early Termination of Procedure|Patients who had procedure termination prior to complete evacuation of the pleural contents (usually as a result of refractory pain or another symptom that the patient perceived).|5-20 minutes||||Participants|||Count of Participants
1303737|NCT03496987|Secondary|Time of Drainage|Actual time of drainage in seconds for each patient.|5-20 minutes|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||seconds||Standard Deviation|Mean
1303738|NCT03496987|Primary|Pain Change|Difference in pain between pre-procedural pain and during drainage pain as measured as the difference between a pre-procedural NPSS pain score (range from 0 (no pain) to 10 (maximum pain)). This was asked again during drainage and the difference between the two was recorded. The values ranged from -10 to 10 (with a more negative number representing a decrease in pain and a more positive number representing an increase in pain)|5-20 minutes|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||Pre-post NPRS Pain Scale Score||Standard Deviation|Mean
1303739|NCT03494985|Secondary|Area Under Curve (AUC) up to 4 Hours After Treatment- Response of All Question of the Modified Product Performance and Attributes Questionnaire I (PPAQ I)|The AUC was calculated for the interval starting at the time of the 30 minute response and ending at the time of the last valid reading using the trapezoidal method on Day 1 and Day 29.|At Day 1 and 29|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Scores on scale/seconds||Standard Deviation|Mean
1303740|NCT03494985|Secondary|Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)|Participants were asked to use the following scale to rate questions of PPAQ II as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ II had following questions; Q1: Providing relief all night, Q2: Reducing the number of times you wake up from dry mouth, Q3: Feeling less parched when you wake up, Q4: Having a long lasting dry mouth relief, Q5. Having a long lasting lubricating effect, Q6: Having a long lasting moisturizing effect. PPAQ II was assessed before supervised product use on Day 8 and 29 of treatment.|At Day 8 and 29|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
1303741|NCT03494985|Secondary|Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8|Participants were asked to use the following scale to rate questions of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQI had following questions Q1: Relieving the discomfort of dry mouth Q2: Feeling comfortable in the mouth, Q3: Soothing your mouth, Q4: Allowing you to speak without difficulty, Q5: Effectively moistens your mouth, Q6: Effectively lubricates your mouth, Q7: Helping to freshen your breath, Q8: Protecting your mouth from drying out, Q9: Providing whole mouth comfort, Q10: Helping you to swallow without difficulty, Q11: Helping mouth feel ‘normal’, Q12: Having a cooling sensation. PPAQ I was assessed at 2 hours after supervised product use on Day 8 of treatment.|At Day 8 (2 hours after supervised product use)|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
1303742|NCT03494985|Secondary|Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)|Participants were asked to use the following scale to rate question (Q) 2 to 12 of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I had following questions Q2: Feeling comfortable in the mouth, Q3: Soothing your mouth, Q4: Allowing you to speak without difficulty, Q5: Effectively moistens your mouth, Q6: Effectively lubricates your mouth, Q7: Helping to freshen your breath, Q8: Protecting your mouth from drying out, Q9: Providing whole mouth comfort, Q10: Helping you to swallow without difficulty, Q11: Helping mouth feel ‘normal’, Q12: Having a cooling sensation. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 and 29 of treatment. Individual score for each question at different tome point was reported for this endpoint.|At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)|ITT(N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
1303743|NCT03494985|Secondary|Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1|Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 of treatment.|At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
1303755|NCT03407612|Secondary|Analgesic Usage|Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications|Initial two postoperative weeks||||morphine equivalent doses||Standard Deviation|Mean
1337589|NCT01972659|Secondary|Rocuronium Onset Time||during the surgery|||||||
1303744|NCT03494985|Secondary|Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29|Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product:1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, and 4 hours after supervised product use on Day 29 of treatment.|At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
1303745|NCT03494985|Primary|Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)|Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 2 hours after supervised product use on Day 29 of treatment.|At Day 29 of treatment (2 hours after supervised product use)|Intent to treat (ITT, N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment. Number of participants analyzed for this endpoint were part of the IIT population, evaluated on Day 29.|||Score on scale||Standard Deviation|Mean
1303746|NCT03489551|Primary|Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant|Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0|Daily, up to 14 days following transplant|Participants completing treatment|||Adverse Event|||Number
1303747|NCT03478644|Secondary|Number of Participants Responses for Consumer Acceptability Questionnaire Score|All the participants supplied with a consumer acceptability questionnaire (Question [Q] 1 to 4) to complete immediately before & after their first use of treatment at home after eating a meal. The number of participants with individual score was reported. After eating & before cleaning denture: Q1= how fresh does denture feel?, Q2= how clean does denture feel?; Look in the mirror and smile, now answer the following questions: Q3= after eating & before cleaning, how clean does denture/smile look ?, Q4= after removing & cleaning denture, how fresh does denture feel?, Q5= after removing & cleaning denture, run your tongue over denture teeth, how clean does denture feel?, Q6= after removing & cleaning denture, how clean does denture/smile look?, Q7= after removing & cleaning denture, how satisfied are you with amount of debris removed? All questions were scored as follows for respective parameter(fresh/clean/satisfied): 0=Not at all, 1=slightly, 2=moderately, 3=very, 4=extremely.|Day 7|Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study.|||Participants|||Count of Participants
1303748|NCT03478644|Secondary|Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use|Dermal assessment performed by a suitably qualified dermatologist on the front and back of the participant’s dominant hand (hand with which participant used to hold the wipe during use) using skin irritation score that range from 0-4 as follows: 0 = no apparent cutaneous involvement, 0.5= equivocal reaction, 1= slight erythema with or without oedema, 2= moderate erythema, oedema with or without papules, 3= severe erythema, oedema with or without papules, 4= severe erythema, oedema with vesicles or blisters. Any site where skin irritation was scored ≥2, was visually assessed and reported.|Day 7, Day 14|Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study.|||Proportion of participants|||Number
1303749|NCT03478644|Primary|Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 7 Days of Use|Proportion of participants experiencing or reporting treatment emergent (TE) oral adverse events (AEs) on or before 7 days of use treatments were reported.|up to 7 days|Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study. No inferential statistical analysis has been performed for this outcome.|||Proportion of participants||95% Confidence Interval|Number
1303750|NCT03478644|Primary|Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use|Proportion of participants experiencing or reporting TE oral AEs on or before 14 days of use treatments were reported.|up to 14 days|Analysis for this outcome was performed on safety population which included all the participants who were randomized and received treatment at least once during the study. No inferential statistical analysis has been performed for this outcome.|||Proportion of participants||95% Confidence Interval|Number
1303751|NCT03446690|Primary|Enamel Decalcification Index (EDI) Scores|Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.|Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.||||scores on a scale||95% Confidence Interval|Mean
1303752|NCT03410628|Secondary|Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack|At the onset of headache pain subjects self-administered treatment with the study device and completed headache pain scores using a 4 point scale (where 3 = severe, 2 = moderate, 1 = mild and 0 = no pain) at baseline (0 minutes) and 120 minutes.|120 minutes|Safety population, 6 subjects had missing data|||units on a scale||Full Range|Mean
1303753|NCT03410628|Primary|Safety - Number of Participants With Adverse Events|Safety was assessed by collecting adverse events for the duration of the study|Up to 4 months|safety population|||Participants|||Count of Participants
1303754|NCT03407612|Secondary|Pain Level|Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.|Initial two postoperative weeks||||units on a scale||Standard Deviation|Mean
1303756|NCT03407612|Primary|Change in Patient Satisfaction and Functional Outcome|Hip Outcome Score Activities of Daily Living (HOS ADL) questionnaire completed at specific time points. Completion of the HOS ADL provides a score from 0 to 100, with a higher score corresponding to greater level of function. The improvement preoperative to 6 month postoperative scores was also computed.|Baseline and 6 weeks, 12 weeks, and 6 months postoperatively||||units on a scale||Standard Deviation|Mean
1303757|NCT03407430|Secondary|Number of Subjects That Experienced a Grade 2 or Higher Adverse Events When Taking Pregabalin|CTCAE The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|Up to 12 weeks||||Participants|||Count of Participants
1303758|NCT03407430|Secondary|Maximum Neuropathic Pain Score Between Pregabalin and Placebo Across the 2 Cycles|"Compare the maximum neuropathic pain score between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ID Pain scale (also know as the Identify Pain scale) is a 6-item, participant-completed screening tool designed to help differentiate nociceptive and neuropathic pain. This pain score also helps to evaluate the presence/absence of neuropathic pain at a given point of time.~Did the pain feel like pins and needles?~Did the pain feel hot/burning?~Did the pain feel numb?~Did the pain feel like electrical shocks?~Is the pain made worse with the touch of clothing or bed sheets?~Is the pain limited to your joints?~A yes response to questions 1-5 are scored as 1; for question 6, a yes is scored as −1. As such, higher scores (approaching 5) signify worse outcomes. The scale's total range for a patient is -1 to 5."|Up to 12 weeks||||units on a scale||Full Range|Mean
1303759|NCT03407430|Secondary|Maximum Change in Pain Score From Baseline Between Pregabalin and Placebo Across the 2 Cycles|"Compare the maximum change in pain score from baseline between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.” Each patient will be assessed regularly, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2)."|Up to 12 weeks||||units on a scale||Full Range|Mean
1303760|NCT03407430|Secondary|Proportion of Patients With Severe Pain Between Pregabalin and Placebo Across the 2 Cycles|"Compare the proportion of patients with severe pain between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”"|Up to 12 weeks||||proportion|||Number
1303761|NCT03407430|Secondary|Number of Days of Breakthrough Analgesic Use Between Pregabalin and Placebo Across the 2 Cycles|"Compare the number of days of breakthrough analgesic use between pregabalin and placebo within cycle 1 and across the 2 cycles.~The number of days of breakthrough analgesic use (i.e additional pain medication being required) is evaluated based on participant-provided medication logs kept during study treatment. If additional pain medication outside of their normal pain control regimen was reported, this day counts as 1. The total days for each patient are then reported, with a total range from zero to 14 (for patients with breast cancer) or zero to 21 (for patients with a lymphoma)."|Up to 12 weeks||||days||Full Range|Mean
1303762|NCT03407430|Secondary|Proportion of Patients Who Have an Increase in Bone/Joint Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1|"Compare the proportion of patients who have an increase in bone/joint pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”"|Up to 12 weeks||||proportion|||Number
1303763|NCT03407430|Secondary|Proportion of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Between Pregabalin and Placebo Across the 2 Cycles|"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline between pregabalin and placebo across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”"|Up to 12 weeks||||proportion|||Number
1303764|NCT03407430|Primary|Number of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1|"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying “no pain” and 10 signifying “the worst pain you can imagine.”"|Up to 12 weeks||||Participants|||Count of Participants
1303765|NCT03405818|Secondary|Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52||Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
1303766|NCT03405818|Secondary|Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52|Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis.|Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
1303767|NCT03405818|Secondary|Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52|Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.|Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
1303768|NCT03405818|Secondary|Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52|Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount).|Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
1303769|NCT03405818|Secondary|Elimination Half-Life of Tavaborole|Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.|Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour||Standard Deviation|Mean
1303770|NCT03405818|Secondary|Elimination Rate Constant of Tavaborole|Elimination rate constant was defined as the rate at which a drug was removed from the body.|Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||per hour||Standard Deviation|Mean
1303771|NCT03405818|Secondary|Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole||Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
1303772|NCT03405818|Secondary|Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole|AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule.|Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
1303773|NCT03405818|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole||Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour||Full Range|Median
1303774|NCT03405818|Secondary|Maximum Observed Plasma Concentration (Cmax) of Tavaborole||Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1303775|NCT03405818|Primary|Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52|Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.|Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants|||Number
1303776|NCT03405818|Primary|Change From Baseline in Vital Sign (Respiratory Rate) at Week 52|Respiratory rate was defined as the number of inspirations per minute.|Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||Breaths per minute||Standard Deviation|Mean
1303777|NCT03405818|Primary|Change From Baseline in Vital Sign (Respiratory Rate) at Week 24|Respiratory rate was defined as the number of inspirations per minute.|Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Breaths per minute||Standard Deviation|Mean
1303778|NCT03405818|Primary|Change From Baseline in Vital Sign (Pulse Rate) at Week 52|Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.|Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||Beats per minute (bpm)||Standard Deviation|Mean
1303779|NCT03405818|Primary|Change From Baseline in Vital Sign (Pulse Rate) at Week 24|Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.|Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Beats per minute (bpm)||Standard Deviation|Mean
1303780|NCT03405818|Primary|Change From Baseline in Vital Sign (Blood Pressure) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1303781|NCT03405818|Primary|Change From Baseline in Vital Sign (Blood Pressure) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1303782|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||millimole per liter (mmol/L)||Standard Deviation|Mean
1303783|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||millimole per liter (mmol/L)||Standard Deviation|Mean
1303784|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1303785|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1303786|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||gram per deciliter (g/dL)||Standard Deviation|Mean
1303787|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||gram per deciliter (g/dL)||Standard Deviation|Mean
1303788|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||International Unit per liter (IU/L)||Standard Deviation|Mean
1303789|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||International Unit per liter (IU/L)||Standard Deviation|Mean
1303790|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||10^9 cells per liter||Standard Deviation|Mean
1303791|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||10^9 cells per liter||Standard Deviation|Mean
1303792|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||gram per deciliter (g/dL)||Standard Deviation|Mean
1303793|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||gram per deciliter (g/dL)||Standard Deviation|Mean
1303794|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||10^12 cells per liter||Standard Deviation|Mean
1303795|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||10^12 cells per liter||Standard Deviation|Mean
1303796|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Hematocrit) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||volume percentage of red blood cells||Standard Deviation|Mean
1303797|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Hematocrit) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||volume percentage of red blood cells||Standard Deviation|Mean
1303798|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of leukocytes||Standard Deviation|Mean
1303799|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of leukocytes||Standard Deviation|Mean
1303800|NCT03405818|Primary|Number of Participants With Adverse Events (AEs) By Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.|Baseline up to 28 days after last dose of study drug (up to Week 52)|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||Participants|||Count of Participants
1303801|NCT03405818|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.|Baseline up to 28 days after last dose of study drug (up to Week 52)|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
1303802|NCT03405818|Primary|Number of Participants With Local Tolerability Reactions by Severity|Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production).|Baseline up to Week 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
1303803|NCT03363633|Secondary|Ulcer Recurrence|Number of participants with ulcers that reopen after initial closure|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
1303804|NCT03363633|Secondary|Compliance With Compression Therapy|Number of participants who use compression therapy|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
1303805|NCT03363633|Secondary|Injection Complications|Number of participants experiencing venous thromboses from injections|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
1303806|NCT03363633|Secondary|Venous Clinical Severity Score (VCSS)|The VCSS includes nine criteria of chronic venous disease, each graded from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Up to three points may be added for differences in background conservative therapy (compression and elevation). The scores are then added, with a maximum score of 30.|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
1303807|NCT03363633|Primary|Ulcer Healing|Change in wound size, reported in square centimeters|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
1303808|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|21 days postoperatively||||Participants|||Count of Participants
1303809|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|14 days postoperatively||||Participants|||Count of Participants
1303810|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|7 days postoperatively||||Participants|||Count of Participants
1303811|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|3 days postoperatively||||Participants|||Count of Participants
1303848|NCT03331315|Secondary|Number of Participants With Perioperative Complications|Perioperative Complications measured intraoperatively and postoperatively by type|During and after surgery||||Patients|||Number
1303812|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|21 days postoperatively||||mL/100g/min||Standard Deviation|Mean
1303813|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|14 days postoperatively||||mL/100g/min||Standard Deviation|Mean
1303814|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|7 days postoperatively||||mL/100g/min||Standard Deviation|Mean
1303815|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|3 days postoperatively|One patient was not able to have Day 3 laser Doppler flowmetry (LDF) readings because of a death in the family, and this patient had to travel out of town for several days.|||mL/100g/min||Standard Deviation|Mean
1303816|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the free gingival graft (FGG) donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|baseline (on the day of surgery before surgery)||||mL/100g/min||Standard Deviation|Mean
1303817|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills taken each day.|21 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303818|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|14 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303819|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|10 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303820|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|7 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303821|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|5 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303822|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|3 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303823|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|2 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303824|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|1 day postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
1303825|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|21 days postoperatively||||Participants|||Count of Participants
1303826|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|14 days postoperatively||||Participants|||Count of Participants
1303849|NCT03331315|Secondary|Total Hospital Stay|Total hospital stay from time fo admission to time of discharge measured in hours|Following surgery||||Hours||Standard Error|Mean
1303827|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|10 days postoperatively||||Participants|||Count of Participants
1303828|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|7 days postoperatively||||Participants|||Count of Participants
1303829|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|5 days postoperatively||||Participants|||Count of Participants
1303830|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|3 days postoperatively||||Participants|||Count of Participants
1303831|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|2 days postoperatively||||Participants|||Count of Participants
1303832|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is “0 to 3,” moderate for “4 to 6,” and severe for “7 to 10.” None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject’s daily functions.|1 day postoperatively||||Participants|||Count of Participants
1303833|NCT03349099|Secondary|Ease of Sheath Placement|Surgeons will be asked to subjectively rate the ease of placement on a standardized scale from 0 to 4, 4 being easiest which will be rated by the surgeon who inserted the sheath immediately after placement.|One time point - at the completion of the procedure|patients undergoing ureteroscopy with each device.|||units on a scale|||Number
1303834|NCT03349099|Secondary|Number of Participants With Injury to the Ureter|Subjective rating of damage to ureter. At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn. Videos are analyzed by two blinded staff endourologists who score ureteral injury on a standard 5-point scale (0 to 4); reference Traxer and Thomas.|One time point - at the completion of the procedure|Patients undergoing procedures with each device.|||Participants|||Count of Participants
1303835|NCT03349099|Primary|Number of Participants With Successful Sheath Placement|The surgeon documents whether there was Successful placement of sheath (yes or no)|One time point - at the beginning of the procedure||||Participants|||Count of Participants
1303836|NCT03346759|Secondary|Change in Relative Abundance of Gardnerella Vaginalis|The differences in relative abundance of Gardnerella vaginalis between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.|Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)|Participants analyzed are those that provided samples through the end of the given menstrual cycle.|||relative abundance||Inter-Quartile Range|Median
1303850|NCT03331315|Secondary|Average Inpatient Ondansetron Use|Average inpatient ondansetron use measured in milligrams|48 hrs following surgery||||Milligrams||Standard Deviation|Mean
1303837|NCT03346759|Primary|Change in Relative Abundance of Lactobacillus Species|The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.|Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)|Participants analyzed are those that provided samples through the end of the given menstrual cycle.|||relative abundance||Inter-Quartile Range|Median
1303838|NCT03338556|Secondary|Incidence(s) of Laboratory Confirmed Illness|The number of subjects with laboratory confirmed HRV-16 infection (as defined by a positive quantitative polymerase chain reaction (qPCR) result from the combined nasal washes of days 3, 4 and 5) who displayed clinical symptoms of upper respiratory tract (using the 10-item diary card, Day 1 to Day 8) – ITT analysis set|8 days|ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)|||participants|||Number
1303839|NCT03338556|Secondary|Area Under Curve of Symptom Scores|"Total symptom scores (from the 10-item modified Jackson symptom diary card) were used to calculate the AUC, from Day 1 (Assessment 1) to Day 8, after challenge, for each subject using the trapezium rule, based on the available non-missing calculated total symptom scores between Day 1 (Assessment 1) and Day 8. The 10-point symptom diary card, measured three times daily was combined to generate total symptom score. The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:~Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache"|8 days|ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)|||scores*minutes||Standard Deviation|Mean
1303840|NCT03338556|Primary|Total Symptom Scores|"Overall total symptom score, defined as the sum of the total symptom scores from day 1 to day 8 inclusive, using the 10-point symptom diary card on a 0 - 3 point scale~The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:~Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache"|8 days|ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)|||units on a scale||Standard Deviation|Mean
1303841|NCT03335566|Secondary|Number of Participants With Accuracy Improvement in Post-contrast Versus Pre-contrast Ultrasound Examination for Lesion-Specific Diagnoses of the Target Lesion Against the Reference Diagnosis/Standard of Truth|The accuracy improvement was calculated by the number of participants with improved diagnoses from the pre-contrast diagnosis to the post-contrast diagnosis divided by the total number of participants. Assessment was performed by 3 blinded readers.|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||Participants|||Count of Participants
1303842|NCT03335566|Secondary|Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results|Confidence in diagnoses from the pre- and post-contrast ultrasound examinations was evaluated based on 4-point scale: 0-Unknown (cannot make a judgement on level of confidence), 1- Not confident (another examination was required), 2- Probable (Would have more confidence if another diagnostic imaging test such as MRI or CT was performed), 3- Definite (Sufficient confidence to the extent that another diagnostic imaging test such as MRI or CT was unnecessary).|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||Participants|||Count of Participants
1303843|NCT03335566|Secondary|Number of Lesions Detected by Post-Contrast US Relative to Number of Lesions Detected by Pre-Contrast US (Both by Blinded Readers[BR]) and Number of Lesions Detected by Post-Contrast US (by BR) Relative to Number of Lesions Detected by RD (Investigators)|For the cases that can be assessed by the blinded readers both pre- and post-contrast, differences were calculated between the Sonazoid™ and SonoVue® groups in the number of lesions detected during whole-liver imaging (post-contrast minus pre-contrast). The differences were also calculated between the Sonazoid™ and SonoVue® groups in the number of lesions (post-contrast minus reference diagnosis) detected during whole-liver imaging.|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||Lesions||Inter-Quartile Range|Median
1303844|NCT03335566|Primary|Number of Participants With Accuracy Improvement in Post-Contrast Versus Pre-Contrast Ultrasound (US) Examination for Diagnosis of the Target Lesion as Malignant or Benign Against the Reference Diagnosis (RD)/Standard of Truth|Accuracy improvement was calculated by the number of participants with improved diagnoses from the pre-contrast diagnosis to the post-contrast diagnosis divided by the total number of participants. Assessments were done by 3 blinded readers. Efficacy population which included all participants who received Sonazoid™ or SonoVue®, for whom pre-contrast & post-contrast images were recorded, & for whom there was a reference standard contrast-enhanced computed tomography (CECT)/contrast-enhanced magnetic resonance imaging (CE-MRI) examination or biopsy.|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||Participants|||Count of Participants
1303845|NCT03331315|Secondary|Number of Oral Narcotic Pills Used After Discharge|Number of oral narcotic pills used after discharge until 2 week postoperative visit.|2 weeks after discharge||||Pills||Standard Deviation|Mean
1303846|NCT03331315|Secondary|Days of Oral Narcotic Use After Discharge|Measured using postoperative questionnaire|2 weeks after discharge||||Days||Standard Deviation|Mean
1303847|NCT03331315|Secondary|Return to Activities of Daily Living|Average number of days required for complete return to independent activities of daily living|2 weeks after discharge||||Days||Standard Deviation|Mean
1303851|NCT03331315|Secondary|Average Inpatient Hydromorphone Use|Average inpatient hydromorphone use measured in milligrams|48 hrs following surgery||||Milligrams||Standard Deviation|Mean
1303852|NCT03331315|Primary|Average Inpatient Postoperative Pain Score|Pain measured using the Visual Analog Scale, no pain (0–0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5–7.4 cm), and severe pain (7.5–10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff.|48 hrs following surgery||||units on a scale||Standard Deviation|Mean
1303853|NCT03330275|Secondary|Average Pedestrian Recognition Distance|The in-vehicle measurement system was utilized to determine the distance at which the participant (as a driver) first recognizes the presence of two pedestrians positioned at the side of the road. An experimenter acted as the pedestrian and “walked in-place” at the end of a 400 m straight section of roadway which starts and finishes at approximately the same elevation, but features a dip halfway along its length. The pedestrian was not surrounded by any visual clutter or lighting. To reduce expectancy effects, a series of four flashing LEDs and four retro-reflective bollards was positioned around the circuit to increase the instances of flashing lights and retro-reflective material being presented to the driver. The average distance to recognize a pedestrian for each lens type was reported.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Meters||Standard Deviation|Mean
1303854|NCT03330275|Secondary|Percentage of Hazards Avoided During Night Driving|Participants were required to report and avoid hitting any of nine large, low contrast grey foam “hazards” (220 cm x 80 cm x 15 cm) positioned orthogonally in the driving lane along the roadway, the locations of which will be randomized between study lenses. The percentage of Hazards avoided for each study lens was reported.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Percentage of Participants|||Number
1303855|NCT03330275|Secondary|Average Distance to Correctly Identify Road Signs During Night Driving|Measure Description The distance (measured in meters) to recognize a pre-determined road sign was recorded for each subject and lens type at either visit 3 or visit 4, using the in-vehicle measurement system while the participant was driving. The in-vehicle measurement system consisted of a subject pressing a button once the subject was able to recognize the road sign. The average distance in meters was reported for each lens type. Larger distance indicate that a subject was able to identify the pre-determined road sign sooner.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Meters||Standard Deviation|Mean
1303856|NCT03330275|Secondary|Percentage of Road Signs Correctly Identified During Night Driving|Participants were instructed to report the identity of a percentage of the standard road signs (typically about 42 signs dependent on the route travelled) containing about 65 items of information as they drove around the circuit. The percentage of correctly identified signs was reported for each study lens.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
1303857|NCT03330275|Secondary|Binocular Contrast Threshold Without Glare|Binocular contrast sensitivity was assessed under low luminance conditions. Five Landolt C targets in random orientation were presented for each of the four contrast levels 95%, 80%, 63% and 50%. Participants were asked to correctly identify the orientation of the Landolt C. The percentage of subjects that were able to correct identify the orientation of all 5 Landolt's C was reported for each lens type.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Percentage of Participants|||Number
1303858|NCT03330275|Secondary|Binocular Visual Acuity|Binocular visual acuity was assessed under Low luminance (~1 lux) high contrast (90%) conditions at a distance of 4 meters. The ETDRS logMAR chart were used, which is scored on a letter by letter basis (-0.02 log units per letter correctly identified). A number of different EDTRS charts was used to reduce potential learning effects. The average LogMAR acuity for each lens was reported.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||logMAR||Standard Deviation|Mean
1303859|NCT03330275|Primary|Overall Nighttime Driving Score|Overall driving performance score is a composite score calculated as the mean of the Z-scores of the following six driving measures: average sign recognition distance (in meters), percentage of correctly identified sign (~42 signs), percentage of hazard avoidance/detection (9 hazards), average pedestrian recognition distance (in meters), lane keeping (percentage of time inside the lane) and the inverse of driving lap time (in seconds).). Equal weighting was assigned to each measure. The individual Z scores were transformed (inverted) such that positive Z scores relate to better performance than the mean. Z scores follow a standard normal distribution (ranging from minus infinity to positive infinity). Overall Z score for night time driving was reported for each study lens.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol violation.|||Z-Score||Standard Deviation|Mean
1303860|NCT03294629|Secondary|Nasal Obstruction Symptom Evaluation (NOSE)|The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.|2 weeks||||units on a scale||Standard Deviation|Mean
1303861|NCT03294629|Secondary|Epworth Sleepiness Score (ESS)|The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.|2 weeks||||units on a scale||Standard Deviation|Mean
1303862|NCT03294629|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.|2 weeks||||units on a scale||Standard Deviation|Mean
1303863|NCT03294629|Secondary|Percentage of Day Used of Auto-CPAP Machine|Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||Percentage of days||Standard Deviation|Mean
1303864|NCT03294629|Secondary|Time Used of Auto-CPAP Machine|Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||minutes||Standard Deviation|Mean
1303865|NCT03294629|Secondary|Residual Apnea-Hypopnea Index (AHI)|Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.|2 weeks||||events per hour||Standard Deviation|Mean
1303866|NCT03294629|Secondary|90th Percentile Leaks of Auto-CPAP Machine|Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||liters per minute||Standard Deviation|Mean
1303867|NCT03294629|Secondary|Average Leaks of Auto-CPAP Machine|Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||liters per minute||Standard Deviation|Mean
1303868|NCT03294629|Secondary|90th Percentile Pressures of Auto-CPAP Machine|90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||cmH2O||Standard Deviation|Mean
1303869|NCT03294629|Secondary|Average Pressures of Auto-CPAP Machine|Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||cmH2O||Standard Deviation|Mean
1303870|NCT03294629|Secondary|Average SA Detections|Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)|2 weeks||||times/hour||Standard Deviation|Mean
1303871|NCT03294629|Primary|Compliance of Auto-CPAP Therapy|Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.|2 weeks||||percentage of nights||Standard Deviation|Mean
1303872|NCT03292692|Secondary|Anxiety Symptoms|Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach’s alpha in the present sample was .91.|Pre (0 weeks) and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
1303873|NCT03292692|Secondary|Depressive Symptoms|Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, & Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.|Pre (0 weeks) and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
1303874|NCT03292692|Secondary|Relationship Confidence|"Relationship confidence as measured by 2 items from the Confidence Scale (“I believe we can handle whatever conflicts will arise in the future” and “I feel good about our prospects to make this relationship work). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach’s alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388)."|Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
1303875|NCT03292692|Primary|Relationship Satisfaction|Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk & Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.|Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
1303876|NCT03279458|Primary|Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.|Tidal volume measured by CPAP mask with Lishom respiratory monitoring device. Tidal volume determined from the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)|5 minutes|Thirty participants successfully completed the experiment, which involved breathing through a CPAP mask in order to have the Linshom device record excursions of the thermistor tracings while the ventilator concurrently measured tidal volume.|||ml||95% Confidence Interval|Least Squares Mean
1303877|NCT03274453|Primary|Hydromorphone Use/24 Hours postOP in mg/kg|Hydromorphone use during the first postoperative 24 hours in mg/kg|24 Hours||||mg/kg||Inter-Quartile Range|Mean
1303878|NCT03271424|Primary|Quantitative Summaries of Participants Experience in Observation Sessions|Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results|12 month post study start||||Participants|||Count of Participants
1303879|NCT03271424|Primary|Qualitative Summaries of Participant Experience in Focus Group Discussions|Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact|6 months post study start||||number of times reported in FGD|||Number
1303880|NCT03263806|Secondary|Hospital Length of Stay|Time from admission to discharge from hospital in days|An average of 2 days|Study terminated with NO data collected.||||||
1303881|NCT03263806|Secondary|Incidence of Major Adverse Cardiac Events|Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization|1 year after presentation|Study terminated with NO data collected.||||||
1303882|NCT03263806|Secondary|Diagnostic Effectiveness|Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy|3 months after initial presentation|Study terminated with NO data collected.||||||
1303883|NCT03263806|Primary|Catheterization Rate|Percent of patients undergoing heart catheterization|3 months after initial presentation|Study terminated with NO data collected.||||||
1303884|NCT03256552|Secondary|FVC AUC0-2|Change from Baseline in FVC AUC0-2 on Day 8 normalized for length of follow-up. FVC was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.|Baseline, Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
1303885|NCT03256552|Secondary|Peak Change in FEV1|Peak Change from Baseline in FEV1|Day 1 and Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
1303886|NCT03256552|Secondary|FEV1 AUC0-2|Change from Baseline in FEV1 AUC0-2 normalized for length of follow-up. FEV1 was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.|Day 1 and Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
1303887|NCT03256552|Primary|Morning Pre-dose Trough FEV1|Change from Baseline in Morning Pre-dose Trough FEV1|Baseline, Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
1303888|NCT03255733|Secondary|Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities|Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)|12 weeks after 1st Treatment||||percentage of reported pain change||Full Range|Mean
1303889|NCT03255733|Primary|Percentage of Patients Reporting at Least 25% Overall Pain Reduction|Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).|12 weeks after 1st Treatment|Percentage of Patients reporting at least 25% improvement in Pain at 12 Weeks after the first treatment|||percentage of patients with less pain|||Number
1303890|NCT03255655|Primary|Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging|Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).|12 Weeks after the first Treatment|Male and Female previously diagnosed with Chronic Plantar Fasciitis, between the age of 18 and 85.|||percentage of Hypoechoic Lesion Change||Standard Error|Mean
1303891|NCT03255655|Primary|Average Percentage of Change as Reported Using Foot Function Index Pain Subscale|Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.|12 weeks after 1st Treatment|Total population of respondents at 12 weeks.|||percentage of Change||Full Range|Mean
1303892|NCT03254602|Secondary|Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline|Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)|At 12 Weeks after the first treatment|Patients receiving 2 Intense Therapeutic Ultrasound treatments beginning 12 weeks ago|||percentage of Change||Full Range|Mean
1303893|NCT03254602|Secondary|Ultrasound Changes|Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments|At 12 Weeks after the first treatment|Patients receiving 2 Intense Therapeutic Ultrasound Treatments - Average % Volume Reduction of Hypoechoic Plantar Fascia Lesions|||percentage of Lesion Size Reduction||Full Range|Mean
1303894|NCT03254602|Primary|Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction|Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.|At 12 weeks after the first treatment|Patients receiving 2 Intense Therapeutic Ultrasound Treatments, beginning 12 Weeks ago.|||Percent of Patients meeting criteria|||Number
1303895|NCT03247985|Secondary|Pain Score at Four Weeks|Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).|Four Weeks Postoperative||||units on a scale||Standard Deviation|Mean
1303896|NCT03247985|Secondary|Pain Score at One Week|Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).|One Week Postoperative||||units on a scale||Standard Deviation|Mean
1303897|NCT03247985|Secondary|Pain Score at Baseline|Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).|baseline||||units on a scale||Standard Deviation|Mean
1303898|NCT03247985|Primary|Number of Participants With Early Postoperative Complications|Any complication which occurred within 30 days after the operation.|Within 30 days||||participants|||Number
1303899|NCT03247985|Primary|Mean Operative Time|Length of time needed to complete surgery.|First incision to closure, approximately one hour||||minutes||Standard Deviation|Mean
1303900|NCT03238924|Secondary|Depression Symptom Severity|Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity.|Change from Baseline to end of treatment (10 weeks)|Data belonging to participants who completed the trial were examined.|||scores on a scale||Standard Deviation|Mean
1303901|NCT03238924|Secondary|PTSD Symptom Severity|PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity.|Change from Baseline to end of treatment (10 weeks)|Data belonging to participants who completed the trial were examined.|||scores on a scale||Standard Deviation|Mean
1303902|NCT03238924|Primary|PTSD Symptom Severity|Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity.|Change from Baseline to end of treatment (10 weeks)|Data belonging to participants who completed the trial were examined.|||scores on a scale||Standard Deviation|Mean
1303903|NCT03238001|Other Pre-specified|Incidence of Serious Device-related Adverse Events [Safety]|Incidence of serious device-related adverse events.|Visit 1 and visit 2, occuring 1-4 weeks apart|All qualified participants who completed at least one DCTclock test.|||Participants|||Count of Participants
1303922|NCT03225001|Secondary|Number of Participants With Mortality From Any Cause|Cardiovascular cause is also included|30 Days||||Participants|||Count of Participants
1303923|NCT03225001|Primary|Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)|The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak|30-day|Twenty-nine patients had missing echocardiography data.|||Participants|||Count of Participants
1303904|NCT03238001|Other Pre-specified|Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments|The goal of this analysis is to assess the construct validity of DCTclock. Specifically, the goal is to compare scores from the administration of DCTclock to the visit 1 administration of a battery of neuropsychological tests, to characterize the psychometric properties of DCTclock, and to compare those properties to the properties of MMSE.|Visit 1 (day 1)|Includes all qualified participants who completed testing at visit 1 and had evaluable data for each test analyzed. Roughly half of the population was administered the full neuropsychological battery. The remainder completed a partial battery (see protocol for details).|||Correlation Coefficient||95% Confidence Interval|Number
1303905|NCT03238001|Secondary|Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)|Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.|Visit 1 and visit 2, occurring 1-4 weeks apart||||Correlation Coefficients||95% Confidence Interval|Number
1303906|NCT03238001|Secondary|Regression Coefficients on Secondary Endpoints (Test-retest Reliability)|Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.|Visit 1 and visit 2, occurring 1-4 weeks apart||||Regression Coefficients||95% Confidence Interval|Number
1303907|NCT03238001|Secondary|Percent Agreement on Secondary Endpoints (Test-retest Reliability)|"Positive percent agreement version A (treating the Indeterminate group as Unimpaired) and version B (removing the Indeterminate group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement."|Visit 1 and visit 2, occurring 1-4 weeks apart|"Version A treats the Indeterminate group as Unimpaired, while version B removes the Indeterminate group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population."|||Percent Agreement||95% Confidence Interval|Number
1303908|NCT03238001|Secondary|Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)|Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).|Visit 1 and visit 2, occurring 1-4 weeks apart||||Quadratic Weighted Cohen's Kappa||95% Confidence Interval|Number
1303909|NCT03238001|Secondary|Correlation Coefficients on Primary Endpoints|Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.|Visit 1 (day 1)||||Correlation Coefficients||95% Confidence Interval|Number
1303910|NCT03238001|Secondary|Regression Coefficients on Primary Endpoints|Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.|Visit 1 (day 1)||||Regression Coefficients||95% Confidence Interval|Number
1303911|NCT03238001|Secondary|Percent Agreement on Primary Endpoints|"Positive percent agreement, version A (treating the Indeterminate group as Unimpaired) and version B (removing the Indeterminate group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations."|Visit 1 (day 1)|"Version A treats the Indeterminate group as Unimpaired, while version B removes the Indeterminate group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population."|||Percent Agreement||95% Confidence Interval|Number
1303912|NCT03238001|Secondary|Quadratic Weighted Kappa on Primary Endpoints|Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.|Visit 1 (day 1)||||Quadratic Weighted Kappa||95% Confidence Interval|Number
1303913|NCT03238001|Primary|Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)|The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.|Visit 1 (day 1)|The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 1.|||Difference in Quadratic Weighted Kappas||90% Confidence Interval|Number
1303914|NCT03235817|Secondary|Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.|Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.|Up to 45 minutes||||breaths per minute||Standard Deviation|Mean
1303915|NCT03235817|Secondary|Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.|Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.|Up to 45 minutes||||breaths per minute||Standard Deviation|Mean
1303916|NCT03235817|Secondary|Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.|Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.|Up to 45 minutes||||breaths per minute||Standard Deviation|Mean
1303917|NCT03235817|Primary|Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups|Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups|up to 45 minutes||||cc/kg||Standard Deviation|Mean
1303918|NCT03235817|Primary|Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups|Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.|Up to 45 minutes||||cc/kg||Standard Deviation|Mean
1303919|NCT03235817|Primary|Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.|Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).|Up to 45 minutes||||cc/kg||Standard Deviation|Mean
1303920|NCT03231371|Secondary|Gadolinium Enhancement by Cardiac MRI|Categorical measure - yes or no; number of participants with gadolinium enhancement|Baseline MRI only|Only 9 participants had MRI data available. Remaining subjects (of 21) did not undergo MRI performed within study time frame.|||Participants|||Count of Participants
1303921|NCT03231371|Primary|Coronary Flow Reserve (CFR)|Ratio of peak to baseline coronary flow velocity (CFV)|Baseline testing (acute only), 3 minutes of adenosine infusion|Remaining subjects (of the 21 who completed) had unusable signal data.|||ratio: peak to baseline CFV||Standard Deviation|Mean
1303924|NCT03222141|Secondary|Number of Participants With Aortic Insufficiency at 30 Days|The proportion of patients with aortic insufficiency ≥ moderate at 30 days.|30 Days|Echo data was available only for 532 patients.|||Participants|||Count of Participants
1303925|NCT03222141|Secondary|Number of Participants With Major Vascular Complications|The rate of major vascular complications at 30 days post implantation|30 Days||||Participants|||Count of Participants
1303926|NCT03222141|Primary|The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate|The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).|30 Days||||percentage of patients||90% Confidence Interval|Number
1303927|NCT03222128|Secondary|Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days||30 Days||||Participants|||Count of Participants
1303928|NCT03222128|Primary|Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate||1 year|AI as a factor in this value; only 964/1069 patients had ECHO data.|||Participants|||Count of Participants
1303929|NCT03222037|Secondary|Area Under Contrast Sensitivity Function Curve|Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd.|15 minutes post treatment administration|All subjects who completed all study visits without a major protocol deviation.|||log|Eyes|Standard Deviation|Mean
1303930|NCT03222037|Primary|Visual Acuity (logMAR)|Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.|15 Minutes post Treatment Administration|Subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
1303931|NCT03218163|Primary|Progression Free Survival|The progression free survival (PFS) of high-risk or relapsed multiple myeloma (MM) patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance therapy with MEDI-551.|5 years|This study was terminated - the patient did not receive study drug.||||||
1303932|NCT03217968|Secondary|Sustained Pain Freedom at 24 Hours|The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.|24 hours||||Participants|||Count of Participants
1303933|NCT03217968|Secondary|Use of Rescue Medication Between 2 and 24 Hours|The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.|Between 2 and 24 hours||||Participants|||Count of Participants
1303934|NCT03217968|Secondary|Migraine-associated Symptoms Freedom at 2 Hours|The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
1303935|NCT03217968|Secondary|Pain Relief (PR) at 2 Hours|The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
1303936|NCT03217968|Primary|Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours|The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.|2 hours||||Participants|||Count of Participants
1303937|NCT03217968|Primary|Pain Freedom (PF) at 2 Hours|The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
1303938|NCT03198000|Secondary|My Eye Appears to Sparkle - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303939|NCT03198000|Secondary|My Eye Appears to Sparkle - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303940|NCT03198000|Secondary|My Eye Appears to Sparkle - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303941|NCT03198000|Secondary|My Eye Appears to Sparkle - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage|Eyes||Number
1303942|NCT03198000|Secondary|My Eye Feels Cool - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303943|NCT03198000|Secondary|My Eye Feels Cool - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303944|NCT03198000|Secondary|My Eye Feels Cool - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage|Eyes||Number
1309222|NCT02614924|Secondary|Intubation Time||up to 10 minutes||||seconds||Inter-Quartile Range|Median
1303945|NCT03198000|Secondary|My Eye Appears Healthy - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303946|NCT03198000|Secondary|My Eye Appears Healthy - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303947|NCT03198000|Secondary|My Eye Appears Healthy - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303948|NCT03198000|Secondary|My Eye Appears Healthy - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage|Eyes||Number
1303949|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303950|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303951|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303952|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage|Eyes||Number
1303953|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303954|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303955|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303956|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage|Eyes||Number
1303957|NCT03198000|Secondary|My Eye Feels Refreshed - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303958|NCT03198000|Secondary|My Eye Feels Refreshed - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303959|NCT03198000|Secondary|My Eye Feels Refreshed - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303960|NCT03198000|Secondary|My Eye Feels Hydrated - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303961|NCT03198000|Secondary|My Eye Feels Hydrated - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303962|NCT03198000|Secondary|My Eye Feels Hydrated - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage|Eyes||Number
1303963|NCT03198000|Secondary|My Eye Feels Hydrated - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage|Eyes||Number
1303964|NCT03198000|Secondary|Change From Baseline in Ocular Comfort at 12 Hours After First Product Application|Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable.|Baseline to 12 hours after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
1303965|NCT03198000|Secondary|Change From Baseline in Ocular Comfort at 10 Hours After First Product Application|Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable.|Baseline to 10 hours after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
1303966|NCT03198000|Secondary|Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application|Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable.|Baseline to 60 seconds after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
1303967|NCT03198000|Secondary|Clinician Assessment of Baseline Redness|Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe).|Baseline|Intent-to-treat set|||units on a scale|eyes|Standard Deviation|Mean
1303968|NCT03198000|Secondary|Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application|Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe).|Baseline to 2 minutes after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
1303969|NCT03198000|Secondary|Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application|Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe).|Baseline to 30 seconds after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
1303970|NCT03198000|Primary|Responder in Redness at 60 Seconds After First Product Application|The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe).|Baseline to 60 seconds after first product application|Intent-to-treat set|||Percentage|Eyes||Number
1303971|NCT03198000|Primary|Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application|Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe).|Baseline to 60 seconds after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
1303972|NCT03196635|Other Pre-specified|Radiation Dose for PA and TC Compressions|Radiation dose (entrance skin air kerma [ESAK] in milligray [mGy]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.|Through study completion, on average 1 month|ESAK was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||mGy|Image Views|Standard Deviation|Mean
1303973|NCT03196635|Other Pre-specified|Breast Thickness for PA and TC Compressions|Breast thickness (millimeter [mm]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.|Through study completion, on average 1 month|Breast thickness (mm) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||mm|Image Views|Standard Deviation|Mean
1303974|NCT03196635|Other Pre-specified|Compression Force for PA and TC Compressions|Compression forces (decanewton [daN]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.|Through study completion, on average 1 month|Compression force (daN) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||daN|Image Views|Standard Deviation|Mean
1303975|NCT03196635|Other Pre-specified|Technologist Interventions in PA Compression|Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.|Through study completion, on average 1 month|Subjects underwent PA compression on their assigned Breast of Interest. Technologists were asked to provide confirmation if any intervention was necessary while the subject was controlling the compression. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||Participants|||Count of Participants
1303976|NCT03196635|Other Pre-specified|Comparison of Image Acquisition Time|The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.|Through study completion, on average 1 month|Imaging time was collected for each image set. 4 image sets were excluded from TC analysis due to repeat imaging per standard of care; repeat imaging wasn't allowed for PA compression. 1 subject’s PA & TC image sets were excluded from analysis due to a protocol deviation. 1 withdrawn subject did not undergo imaging, so was not part of the analysis.|||minutes||Standard Deviation|Mean
1303977|NCT03196635|Secondary|Acceptability of Mammographic Attributes|Acceptability of mammographic attributes using a binary response of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets were summarized.|Through study completion, on average 1 month|The PA and TC image sets for all 30 subjects were evaluated for acceptability of pre-defined set of mammography attributes by Readers 1 and 2. Adjudication was not required if there was disagreement between the readers. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||image sets|||Number
1304010|NCT03184077|Secondary|Postpartum Pain|To assess overall perineal pain using a visual analog scale on a range of 0-10, with 0 being no pain and 10 being worst imaginable pain Scale used - Pain Numeric Rating Scale. A minimal score of 0 indicates no pain whereas a maximums core of 10 indicates the worse imaginable pain.|6 weeks postpartum||||units on a scale||Standard Deviation|Mean
1304095|NCT03124199|Secondary|Tolerability of Treatment|Patients with side effects present during treatment and in the 4 weeks after end of treatment|1 month||||participants|||Number
1303978|NCT03196635|Secondary|Repeat Image Acquisition|Number of incidences per image set when the technologists or readers indicated a repeat acquisition for PA and TC compression modes. More than one incident (i.e. reason for repeat from technologist or view indicated for repeat by readers) could have been selected for a given image set.|Through study completion, on average 1 month|Instances of repeat imaging for each subject's PA (N=30) and TC (N=30) image sets were indicated by technologists during image acquisitions and by readers during image evaluations. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||Image sets|Image sets||Count of Units
1303979|NCT03196635|Primary|Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets|One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.|Through study completion, on average 1 month|60 image sets (30 PA and 30 TC compression image sets from 30 participants) were evaluated for acceptability of overall clinical image quality by two readers. The one (1) withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||Participants|||Count of Participants
1303980|NCT03192306|Secondary|Subject Assessed Duration of Pain|Time of first occurrence of at least mild pain to consistent scoring of no pain|From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days|Subjects with cold sore lesions pain assessment|||Participants|||Count of Participants
1303981|NCT03192306|Secondary|Clinician Assessed Duration of the Herpetic Lesion Hard Scab|Duration of the hard crust (Stage 5)|From start of Stage 5 to loss of hard crust - maximum of 14 days|Only those subjects who developed a cold sore with a hard scab (Stage 5) were analyzed for this endpoint.|||hours||Standard Deviation|Mean
1303982|NCT03192306|Secondary|Clinician Assessed Lesion Size|Maximum lesion area for ulcerative lesions during Stages 3-5|14 days maximum|Subjects who developed a classical herpetic lesion during the course of the trial.|||square mm||Standard Deviation|Mean
1303983|NCT03192306|Secondary|Clinician Assessed Prevention of Progression to Classical Lesion|Proportion of subjects in each treatment group who do not display classical lesions|14 days maximum|Subjects who developed a cold sore lesion and treated during the course of the trial.|||Participants|||Count of Participants
1303984|NCT03192306|Secondary|Clinician Assessed Duration Until Complete Healing of the Herpetic Episode|The time, in hours, from the beginning of treatment to onset of Stage 7|From the beginning of treatment to onset of Stage 7 - maximum of 14 days|Subjects who developed a cold sore and treated during the course of the trial|||hours||Standard Deviation|Mean
1303985|NCT03192306|Secondary|Clinician Assessed Duration of the Herpetic Episode|For classical lesions: the time in hours from the beginning of the treatment until loss of hard crust (Stage 6); for non-classical lesions the time from the beginning of treatment until complete resolution of all local signs and symptoms (Stage 7)|For classical lesions: from the beginning of the treatment until loss of hard crust (Stage 6); for non-classical lesions the time from the beginning of treatment until complete resolution of all local signs and symptoms (Stage 7) - maximum of 14 days|Subjects who developed a cold sore lesion and treated during the course of the trial.|||hours||Standard Deviation|Mean
1303986|NCT03192306|Primary|Clinician Assessed Duration of the Classical Herpetic Lesion|The time in hours from beginning of treatment to onset of Stage 6 (residual swelling) or Stage 7 (complete healing) if Stage 6 never observed|From time of beginning of treatment until onset of Lesion Stage 6 or Stage 7, if Stage 6 never observed, with a maximum of 14 days.|Only those subjects who developed a classical cold sore lesion, i.e. exhibited Stages 3, 4 or 5, during the course of the trial and treated were analyzed for this endpoint.|||hours||Standard Deviation|Mean
1303987|NCT03191552|Secondary|Parent Satisfaction Questionnaire Total Score|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child’s sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child’s confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|3 months||||units on a scale||Standard Deviation|Mean
1303988|NCT03191552|Secondary|Parent Satisfaction Questionnaire Total Score|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child’s sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child’s confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|1 month||||units on a scale||Standard Deviation|Mean
1304028|NCT03162458|Secondary|Average Duration of Fever (i.e. Body Temperature >37.3°С)|based on patient diary data|From the time of randomization until the time of normal body temperature, assessed up to 14 days|Intention to treat set|||hours||Standard Deviation|Mean
1304029|NCT03162458|Secondary|Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)|based on patient diary data|On Days 2-5 of the treatment|Intention to treat set|||percentage of participants|||Number
1304189|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after third intervention|||||||
1303989|NCT03191552|Secondary|Parent Satisfaction Questionnaire Total Score|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child’s sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child’s confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|2 weeks||||units on a scale||Standard Deviation|Mean
1303990|NCT03191552|Secondary|Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child’s sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child’s confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|3 months||||units on a scale||Standard Deviation|Mean
1303991|NCT03191552|Secondary|Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child’s sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child’s confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|1 month||||units on a scale||Standard Deviation|Mean
1303992|NCT03191552|Secondary|Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child’s sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child’s confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|2 weeks||||units on a scale||Standard Deviation|Mean
1303993|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|3 months||||units on a scale||Standard Deviation|Mean
1303994|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|1 month||||units on a scale||Standard Deviation|Mean
1303995|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|2 weeks||||units on a scale||Standard Deviation|Mean
1304009|NCT03184077|Secondary|Overall Sexual Function|"Level of sexual desire or interest on a scale of 1-5, with 5 being the highest level of interest~Scale used - Female Sexual Function Index -6 where 0 indicates no sexual activity, 1 indicates a worse outcome and 5 indicates a better outcome.~The scale assesses sexual desire, arousal, lubrication, orgasm, sexual satisfaction and sexual pain.~A score of 1 indicates very low desire, arousal, almost never or never becoming lubricated or achieving orgasm, being very dissatisfied with sexual life and almost always or always having pain with intercourse.~A score of 5 indicates very high desire, arousal, almost always or always becoming lubricated or achieving orgasm, being very satisfied with sexual life and almost never or never having pain with intercourse."|3 months||||units on a scale||Standard Deviation|Mean
1303996|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|Immediate after orthosis is worn|The immediate effect of orthosis could only be evaluated in SPIO groups because the orthosis is tailor made and only children in SPIO groups had the orthosis. Given that the number of the objects in each SPIO group is 8, immediate effect of the orthosis could only be evaluated in children recruited in SPIO groups.|||units on a scale||Standard Deviation|Mean
1303997|NCT03191552|Secondary|Gross Motor Function Measure-B, Sitting Dimension|Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).|3 months||||units on a scale||Standard Deviation|Mean
1303998|NCT03191552|Secondary|Gross Motor Function Measure-B, Sitting Dimension|Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).|1 month||||units on a scale||Standard Deviation|Mean
1303999|NCT03191552|Secondary|Gross Motor Function Measure-B, Sitting Dimension|Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).|2 weeks||||units on a scale||Standard Deviation|Mean
1304000|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively|3 months||||units on a scale||Standard Deviation|Mean
1304001|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively|1 month||||units on a scale||Standard Deviation|Mean
1304002|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively|2 weeks||||units on a scale||Standard Deviation|Mean
1304003|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively.|Immediate after orthosis is worn|The immediate effect of orthosis could only be evaluated in SPIO groups because the orthosis is tailor made and only children in SPIO groups had the orthosis. Given that the number of the objects in each SPIO group is 8, immediate effect of the orthosis could only be evaluated in children recruited in SPIO groups.|||units on a scale||Standard Deviation|Mean
1304004|NCT03184441|Secondary|Premie Pouch Ease of Use|This the percentage or nurses that found the Premie Pouch device easy to use.|From date of enrollment to date of study completion (range 19-47 days)||||Participants|||Count of Participants
1304005|NCT03184441|Secondary|Number of Participants With Normal Cranial Symmetry|To assess for cranial asymmetry of the head shape at study completion, the right anterior-posterior measures and left anterior-posterior measures of infant's head shapes were obtained. Cranial symmetry was defined as less than 8mm difference in the right and left anterior-posterior measures.|Cranial symmetry at study completion|Normal Cranial Symmetry|||Participants|||Count of Participants
1304006|NCT03184441|Secondary|Number of Participants With Normal Cranial Index|Cranial index (An objective front to back and side to side, measure that quantifies head shape by dividing head width by length then multiplying it by 100%) for each of participants was measured at study completion. Participants falling within the normal range of 73%-85% had normal cranial index.|Cranial index at study completion|Normal cranial index at study completion|||Participants|||Count of Participants
1304007|NCT03184441|Secondary|Feasibility of Use of the Premie Pouch in VLBW Infants|Documented hours per day (24 hours) on the Premie Pouch device|Number of hours per each 24 hour period on the device|Hours on device per day|||hours per day||Full Range|Mean
1304008|NCT03184441|Primary|Safety of Use of the Premie Pouch in VLBW Infants|Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.|From date of enrollment to date of study completion (range 19-47 days)|Participants with adverse events|||participants|||Number
1304094|NCT03124199|Secondary|Compliance With Treatment of Patients That Completed the Study|Percentage of patients that has comply with treatment, considered as intake of more than 90% of study drugs in patients who attended the post-treatment visit.|1 month||||percentage of participants|||Number
1304011|NCT03184077|Primary|Rates of Dyspareunia|"To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to monocryl using a validated sexual function questionnaire, with higher scores indicating greater discomfort or pain.~Scale used - Female Sexual Function Index -6 where 0 indicates no sexual activity, 1 indicates a worse outcome and 5 indicates a better outcome.~The scale assesses sexual desire, arousal, lubrication, orgasm, sexual satisfaction and sexual pain.~A score of 1 indicates very low desire, arousal, almost never or never becoming lubricated or achieving orgasm, being very dissatisfied with sexual life and almost always or always having pain with intercourse.~A score of 5 indicates very high desire, arousal, almost always or always becoming lubricated or achieving orgasm, being very satisfied with sexual life and almost never or never having pain with intercourse."|3 months postpartum||||units on a scale||Standard Deviation|Mean
1304012|NCT03182582|Secondary|Percent Change in Wound Size - 1 Week Post-debridement||1 week following respective procedure||||percent change in wound size||Standard Deviation|Mean
1304013|NCT03182582|Secondary|Percent Change in Wound Size - Immediately Post-debridement||Day 1 of the respective procedure (immediately after)||||percent change in wound size||Standard Deviation|Mean
1304014|NCT03182582|Secondary|Patient Preference|Patient-reported preference of debridement type one week after study completion, reported as the count of participants that preferred either method.|2 weeks|Survey respondents were included in the analysis.|||Participants|||Count of Participants
1304015|NCT03182582|Primary|Bacterial Load Pre- and Post-Sharp Debridement|Bacterial load in wound as per tissue biopsy, pre- and post-sharp debridement|Day 1 of the sharp procedure (immediately before and after)||||Participants|||Count of Participants
1304016|NCT03182582|Primary|Bacterial Load Pre- and Post-Laser Debridement|Bacterial load in wound as per tissue biopsy, pre- and post-laser debridement. Patient pain level by visual analog scale ranging 0-10. 0 being low pain, and 10 being more pain. CFU = Colony Forming Units.|Day 1 of the laser procedure (immediately before and after)||||Participants|||Count of Participants
1304017|NCT03182582|Primary|Pain With Debridement|"Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is used in our study to measure the intensity or frequency of pain. We have used Numerical Rating Scale (NRS), variant of VAS, which is a validated, uni-dimensional measure of pain intensity reported on an 11-point numeric scale. The scores were reported from 0 to 10, with 0 representative of no pain, and 10 representative of the worst possible pain."|Day 1 of the respective procedure (immediately following)||||units on a scale||Standard Deviation|Mean
1304018|NCT03180138|Secondary|Timeliness of Vaccinations|The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.|12 months|The events analyzed here are the total number of vaccines rather than subjects in each cohort. The outcome measure is the percent of the number of vaccines that were administrated in a timely manner divided by the total number of scheduled vaccines.|||Percentage of vaccines|Vaccines||Number
1304019|NCT03180138|Primary|Immunization Rate|Percent of the total number of immunizations received divided by the total number of immunizations required at the time of measurement for each child. Calculated for each child and in each cohort.|12 months||||Percentage of immunizations||Inter-Quartile Range|Median
1304020|NCT03163134|Secondary|Number of Participants With Postoperative Complications|Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.|1 year||||Participants|||Count of Participants
1304021|NCT03163134|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Leak|Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.|1month||||Participants|||Count of Participants
1304022|NCT03162458|Secondary|Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation||From the time of randomization up to 14 days|Intention to treat|||percentage of participants|||Number
1304023|NCT03162458|Secondary|Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)|based on patient diary data|on Days 1-5 of treatment|Intention to treat set|||Number of intakes||Standard Deviation|Mean
1304024|NCT03162458|Secondary|"Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)"|"The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.~The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).~The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).~Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6."|on Days 1, 3, 6|Intention to treat set|||AUC score*day||Standard Deviation|Mean
1304025|NCT03162458|Secondary|Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination|"The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.~The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).~The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).~Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6."|On Days 1, 3, 6 of the treatment|Intention to treat set|||Score||Standard Deviation|Mean
1304026|NCT03162458|Secondary|Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation|based on patient diary data|On Days 2-5 of observation|Intention to treat set|||percentage of participants|||Number
1304027|NCT03162458|Secondary|Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)|based on patient diary data|On Days 2-5 of the treatment|Intention to treat set|||°C||Standard Deviation|Mean
1304030|NCT03162458|Primary|"Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient)."|"The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.~The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).~The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).~Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5."|On days 1-5 of observation|Intention to treat set|||AUC score*day||Standard Deviation|Mean
1304031|NCT03162458|Primary|Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement – Based on Patient Diary Data)|based on patient diary data|From the time of randomization until the time of recovery/improvement, assessed up to 14 days|Intention to treat set|||hours||Standard Deviation|Mean
1304032|NCT03159143|Secondary|Overall Survival|The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.|Up to 4 years|Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.|||months||95% Confidence Interval|Median
1304033|NCT03159143|Secondary|Disease Control Rate (DCR)|Percentage of patients who achieved complete response, partial response and stable disease. DCR will be calculated from the first day of the first cycle to the date of metastatic or primary tumor relapse, or last contact date, or date of death (if death comes before disease progression), or data cut-off.|Up to 4 years|Patients who received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects|||percentage of participants||95% Confidence Interval|Median
1304034|NCT03159143|Secondary|Time to Progression (TTP)|Time to progression (TTP) will be calculated as number of months from the date of first treatment to the date of disease progression or the date of death (disease-related causes) or the cut-off date.|Up to 4 years|Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.|||months||95% Confidence Interval|Median
1304035|NCT03159143|Primary|Response Rate|Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.|Up to 4 years|Patients who received between 1 and 6 cycles of oxaliplatin with docetaxel.|||percentage of participants||95% Confidence Interval|Number
1304036|NCT03157232|Primary|Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation|Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours per subject||||g/dL|||Number
1304037|NCT03151226|Primary|Respiratory Depression/Suppression|defined by values obtained utilizing capnography and pulse oximetry|up to 24 hours|the 2 subjects who wore device did not wear the device enough to be evaluable data||||||
1304038|NCT03150485|Secondary|Subject's Responses to Individual Item 10|"Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304039|NCT03150485|Secondary|Subject's Responses to Individual Item 9|"Subjects responses to individual item How would you rate your overall visual performance with the study contact lens?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304040|NCT03150485|Secondary|Subject's Responses to Individual Item 8|"Subjects responses to individual item Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?. This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304041|NCT03150485|Secondary|Subject's Responses to Individual Item 7|"Subjects responses to individual item Study Compare To Your Current Vision Correction Solutions?. This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304042|NCT03150485|Secondary|Subject's Responses to Individual Item 6|"Subjects responses to individual item What Are Your Current Vision Correction Solutions?. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304043|NCT03150485|Secondary|Subject's Responses to Individual Item 5|"Subjects responses to individual item If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?. This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304044|NCT03150485|Secondary|Subject's Responses to Individual Item 4|"Subjects responses to individual item Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1308868|NCT02632812|Primary|Intragastric pH||8 days|Intragastric PH measurement was not performed and for this reason it will not be available.||||||
1304045|NCT03150485|Secondary|Subject's Responses to Individual Item 3|"Subjects responses to individual item Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?. This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304046|NCT03150485|Secondary|Subject's Responses to Individual Item 2|"Subjects responses to individual item Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?. This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304047|NCT03150485|Secondary|Subject's Responses to Individual Item 1|"Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?. This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
1304048|NCT03150485|Primary|The Average Number of Fitting Modifications to Optimize Vision|The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported.|15 minutes post lens insertion|Subjects that completed all study visits without a major protocol deviation.|||Lens|Eyes|Standard Deviation|Mean
1304049|NCT03135379|Secondary|Ultrasound Image Quality|Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.|Within 1 week of completion of ultrasound examination||||units on a scale||Inter-Quartile Range|Median
1304050|NCT03135379|Primary|Patient Satisfaction|"Measured on 100-mm visual analogue scale. This scale is a horizontal line on a sheet of paper measuring 100 mm. The scale ranges from 0 on the left (representing completely unsatisfied) to 100 on the right (representing completely satisfied). We instructed subjects to draw a single vertical mark through the horizontal line to represent how satisfied they were with their overall emergency department visit."|Immediately upon completion of ultrasound examination||||units on a scale||95% Confidence Interval|Mean
1304051|NCT03134326|Primary|Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation|Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||g/dL|||Number
1304052|NCT03134313|Primary|Accuracy of SpHb on R1-25 by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours per subject||||g/dL|||Number
1304053|NCT03134248|Primary|Lens Preference With Respect to Visual Quality|Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference|1 week||||Participants|||Count of Participants
1304054|NCT03134248|Primary|Lens Preference With Respect to Overall Comfort|Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference|1 week||||Participants|||Count of Participants
1304055|NCT03134248|Primary|Visual Quality|Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied|1 week||||units on a scale||Standard Deviation|Median
1304056|NCT03134248|Primary|Dryness|Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness|1 week||||units on a scale||Standard Deviation|Median
1304057|NCT03134248|Primary|Comfort|Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.|1 week||||units on a scale||Standard Deviation|Median
1304058|NCT03134183|Secondary|Cervical Dilation|Pratt Dilator initially accepted without resistance starting from 65 and working down|At end of procedure||||“French” circumference in millimeters||Standard Deviation|Mean
1304059|NCT03134183|Primary|Procedure Time|Time from initial uterine instrumentation to speculum out|At end of procedure||||minutes||Standard Deviation|Mean
1304060|NCT03129321|Secondary|Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure|To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum|Day 42|Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure.|||Participants|||Count of Participants
1304061|NCT03129321|Secondary|Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient’s Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)|The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging|Day 42|Modified Intent to Treat|||Participants|||Count of Participants
1304062|NCT03129321|Secondary|Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure|To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum|Day 42|Active treatment groups of the Per Protocol population|||Participants|||Count of Participants
1304063|NCT03129321|Secondary|Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient’s Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)|The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging|Day 42|Active treatment groups of the Per Protocol population|||Participants|||Count of Participants
1304064|NCT03129321|Primary|Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure|To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient’s total severity score must be ≤ 2 with no individual severity score > 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis|Day 42|Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure.|||Participants|||Count of Participants
1304065|NCT03129321|Primary|Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure|To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient’s total severity score must be ≤ 2 with no individual severity score > 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis|Day 42|Active Treatments of the Per Protocol Population|||Participants|||Count of Participants
1304066|NCT03128723|Secondary|Cutaneous Tolerance Scores: Tightness/Dry|Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 14. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.|Baseline to Day 14||||Units on a scale||Standard Error|Mean
1304067|NCT03128723|Secondary|Cutaneous Tolerance Scores: Itching|Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 14. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.|Baseline to Day 14||||Units on a scale||Standard Error|Mean
1304068|NCT03128723|Secondary|Cutaneous Tolerance Scores: Burning/Stinging|Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 14. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
1304069|NCT03128723|Secondary|Cutaneous Tolerance Scores: Edema|Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 14. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
1304070|NCT03128723|Secondary|Cutaneous Tolerance Scores: Dryness/Scaling|Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 14. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
1304071|NCT03128723|Secondary|Cutaneous Tolerance Scores: Erythema|Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 14. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
1304072|NCT03128723|Primary|Cutaneous Tolerance Scores: Tightness/Dry Feeling|Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 28. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
1304073|NCT03128723|Primary|Cutaneous Tolerance Scores: Itching|Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 28. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
1304074|NCT03128723|Primary|Cutaneous Tolerance Scores: Burning/Stinging|Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 28. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
1304075|NCT03128723|Primary|Cutaneous Tolerance Scores: Edema|Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 28. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
1304076|NCT03128723|Primary|Cutaneous Tolerance Scores: Dryness/Scaling|Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 28. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
1304077|NCT03128723|Primary|Cutaneous Tolerance Scores: Erythema|Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 28. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
1304078|NCT03128307|Primary|Visual-Analogue Scale, Self-Reported Snoring Habits|Quantitative assessment on 1-10 scale. Outcome measurement reported as a percentage change from pre-trial with use of the device. A negative ('-') percentage would indicate a reduction in snoring symptoms as measured by the VAS, while a positive percentage ('+') result would indicate an increase in the measured symptom.|Baseline and 10 Days||||percent change|||Number
1304092|NCT03124758|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-5 hours||||g/dL|data points||Number
1304093|NCT03124693|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.|Up to 24 hours||||g/dL|||Number
1304079|NCT03128307|Primary|Snoring Severity Scale|"The Snoring Severity Scale (SSS) is a 9-point, validated scale to measure the severity of snoring. A total of three questions are asked: 1) How often do you snore, 2) How long do you snore, and 3) How audible is your snoring. Answers for each of these questions are summed for a total SSS score. A score of '0' would indicate no snoring at all, while a score of '9' would indicate the most severe snoring as measured by the SSS.~Outcome measure reported as change with use of the device over pre-trial. In this case, a negative ('-') would represent improvement in snoring symptoms, while a positive ('+') number would indicate an increase in snoring severity."|Baseline and 10 Days||||units on a scale||Standard Deviation|Mean
1304080|NCT03125031|Primary|Accuracy of Noninvasive Sensors by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. The accuracy results from both sensors will be assessed for equivalence|1-5 hours||||g/dL|data points||Number
1304081|NCT03125018|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
1304082|NCT03125005|Primary|Accuracy of Sensor by Arms Calculation|Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|5 hours||||Percentage of total hemoglobin|||Number
1304083|NCT03124979|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
1304084|NCT03124966|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-3 hours||||g/dL|||Number
1304085|NCT03124927|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.|5 hours||||percentage|||Number
1304086|NCT03124901|Primary|Accuracy of Sensor|Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|Up to 24 hours||||g/dL|||Number
1304087|NCT03124836|Primary|Accuracy of Methemoglobin Measurement by Arms Calculation|Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||percentage of total hemoglobin|||Number
1304088|NCT03124823|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
1304089|NCT03124797|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
1304090|NCT03124784|Primary|SpO2 ARMS of Sensor Under Motion Conditions|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|2 subjects were excluded from data analysis: one due to adverse event and the other due to equipment malfunction.|||% of oxygen saturated hemoglobin|||Number
1304091|NCT03124771|Primary|Accuracy of Sensor by Arms Calculation|Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-5 hours||||g/dL|data points||Number
1309912|NCT02590003|Primary|Treatment Failure-free Survival||90 days||||Participants|||Count of Participants
1304096|NCT03124199|Primary|Percentage of Participants With H.Pylori Infection Eradication|Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment|1 month||||percentage of participants||95% Confidence Interval|Number
1304097|NCT03123848|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|Up to approximately 1 month|Safety analysis set included all participants who received the study drug. AEs for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately as per planned analysis.|||Participants|||Number
1304098|NCT03123848|Primary|Apparent Total Body Clearance of Drug at the Terminal Phase After Extravascular Administration (CL/F)|CL/F is the apparent total body clearance of drug at the terminal phase after extravascular administration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. CL/F for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||milliliter per hour (mL/h)||Standard Deviation|Mean
1304099|NCT03123848|Primary|Apparent Volume of Distribution (Vz/F)|Vz/F is defined as the apparent volume of distribution at the terminal phase after extravascular administration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Vz/F for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||milliliter (mL)||Standard Deviation|Mean
1304100|NCT03123848|Primary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. t1/2 for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||Hour||Standard Deviation|Mean
1304101|NCT03123848|Primary|Elimination Rate Constant (Lambda[z])|Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Lambda[z] for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||per hour (1/h)||Standard Deviation|Mean
1304102|NCT03123848|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-infinity)|AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. AUC0-inf for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||h*ng/mL||Standard Deviation|Mean
1304103|NCT03123848|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time the Last Quantifiable Time (AUC[0-last])|AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time the last quantifiable time, calculated by linear trapezoidal summation.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration time zero to time the last quantifiable time. AUC[0-last] for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
1304104|NCT03123848|Primary|Time to Reach the Maximum Plasma Concentration (Tmax)|Tmax is defined as the time to reach the maximum plasma concentration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Tmax for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||hour (h)||Full Range|Median
1304105|NCT03123848|Primary|Concentration at Last Quantifiable Time Point (Clast)|Clast is defined as concentration at last quantifiable time point.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Clast for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||ng/mL||Standard Deviation|Mean
1304106|NCT03123848|Primary|Maximum Observed Plasma Concentration (Cmax)|The Cmax is the maximum observed plasma concentration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|Pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Cmax for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1304107|NCT03123354|Primary|Accuracy of Sensor by Arms Calculation of Percent rSO2|The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.|One visit; up to 4 hours||||%rSO2|||Number
1304190|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after second intervention|||||||
1304108|NCT03119831|Other Pre-specified|Total Bacterial Counts (TBC)|Levels of bacterial counts, expressed in total bacterial DNA mass (ng) and total number of bacteria. TBC was evaluated by real-time Polymerase Chain Reaction (PCR).|Plaque samples were collected at the 14th postsurgical day.|The inconsistency between the overall number of participants analyzed and the numbers provided in the rows in the participant flow module is due to the fact that there were no microbiological data from three patients in Group B and from another three participants in Group C, because their pooled plaque samples were destroyed during processing.|||log10 of copy numbers of bacterial DNA||Inter-Quartile Range|Median
1304109|NCT03119831|Secondary|Plaque Area Index (PA%)|Assessment of the accumulation of dental plaque at buccal tooth surfaces between baseline (immediately before surgery), 7 and 14 days postoperatively. PA% referred at the percentage of the total buccal surface area of the included teeth covered by dental plaque. PA% values range between 0-100%|PA% was recorded at the 7th and 14th postoperative day||||percentage of buccal surface area||Inter-Quartile Range|Median
1304110|NCT03119831|Secondary|Plaque Index (PI)|"PI measurements range between 0-3:~0 = No plaque~= A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.~= Moderate accumulation of soft deposits on the tooth and gingival margin which can be seen with the naked eye.~= Abundance of soft matter on the tooth and gingival margin."|PI was recorded 14 days postoperatively||||units on a scale||Inter-Quartile Range|Median
1304111|NCT03119831|Primary|Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI)|"EHI measurements range between 1-5:~= Complete flap closure–no fibrin line in interproximal area.~= Complete flap closure–fibrin line in interproximal area.~= Complete flap closure–fibrin clot in the interproximal area.~= Incomplete flap closure–partial necrosis of interproximal tissue.~= Incomplete flap closure–complete necrosis of the interproximal tissue."|Early Wound Healing Index was recorded at the 7th and 14th postsurgical day||||units on a scale||Inter-Quartile Range|Median
1304112|NCT03118297|Secondary|Ovulation Status Measured by Weekly Serum Progesterone Levels|To evaluate effect, if any, of ulipristal acetate on ovulation status. Data in the table represent the lowest and highest values that were recorded over all of the measurements for each arm as a whole.|Baseline, weeks 1, 2, 3, 4|See baseline characteristics|||ng/mL|||Number
1304113|NCT03118297|Secondary|Number of Participants With Medication Side Effects by 30 Days|To evaluate participant satisfaction with regards to medication side effects.|30 days|See baseline characteristics|||participants|||Number
1304114|NCT03118297|Secondary|Participant Satisfaction With Bleeding Pattern at 30 Days|To evaluate participant satisfaction with regards to bleeding pattern after use of ulipristal acetate.|30 days|See baseline characteristics|||Participants|||Count of Participants
1304115|NCT03118297|Secondary|Number of Participants With Bleeding Cessation by Day 10|To evaluate bleeding cessation rates by day 10 following seven days of treatment with either ulipristal acetate or placebo.|10 days|See baseline characteristics|||Participants|||Count of Participants
1304116|NCT03118297|Primary|Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries|To evaluate the effectiveness of ulipristal acetate (15mg) in decreasing bleeding/spotting days due to the ENG implant over a 30-day period as compared to placebo.|30 days|See baseline characteristics|||days||Inter-Quartile Range|Median
1304117|NCT03117140|Other Pre-specified|Surgical Length|Surgical length was recorded|Post op Day 0 (Baseline)||||minutes||Inter-Quartile Range|Median
1304118|NCT03117140|Other Pre-specified|Surgical Position|Surgical position was recorded|Post-op Day 0 (Baseline)||||Participants|||Count of Participants
1304119|NCT03117140|Secondary|Number of Patients Reporting Itching at Home|Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.|1-3 days||||Participants|||Count of Participants
1304120|NCT03117140|Secondary|Number of Patients Reporting Itching in the PACU|Patients itching was assessed post-op in the PACU.|Post-op day 0 (baseline)|1 patient in the Ropivacaine and Buprenorphine group did not obtain data on the itching in the PACU therefore was not included in the analysis|||Participants|||Count of Participants
1304121|NCT03117140|Secondary|Pain Score Reported by Patients at First Phone Call|Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.|Day 1-3||||units on a scale||Inter-Quartile Range|Median
1304122|NCT03117140|Secondary|Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area|Blood pressure changes in Second Stage Recovery Area for patients was looked at|Post-op Day 0 (baseline)|1 patient in Ropivacaine and Buprenorphine group did not have blood pressure data obtained in the second stage area so therefore was not included in the analysis|||Participants|||Count of Participants
1304123|NCT03117140|Secondary|Number of Patients With Blood Pressure (BP) Changes in the PACU|Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at|Post-op Day 0 (baseline)|1 patient in Ropivacaine and Buprenorphine group did get data for the BP changes in the PACU for the study so therefore was not included in the analysis|||Participants|||Count of Participants
1304124|NCT03117140|Secondary|Motor Duration of Block|Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off|Day 1-3||||minutes||Inter-Quartile Range|Median
1304125|NCT03117140|Secondary|Number of Patients Reporting Nausea in the PACU|PACU (Post-Anesthesia Care Unit) assessment of nausea|Post-op day 0 (Baseline)||||Participants|||Count of Participants
1304126|NCT03117140|Secondary|Number of Patients Reporting Nausea at Home|Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.|1-3 days|1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about nausea at home and therefore was not included in the analysis|||Participants|||Count of Participants
1304127|NCT03117140|Secondary|Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)|Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at|Post-op Day 0 (Baseline)||||Participants|||Count of Participants
1304128|NCT03117140|Secondary|Patient Reporting Vomiting at Home|Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.|1-3 days|1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about vomiting at home and therefore was not included in the analysis|||Participants|||Count of Participants
1304129|NCT03117140|Secondary|Sensory Duration of Block|Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off|Day 1-3||||minutes||Inter-Quartile Range|Median
1304130|NCT03117140|Secondary|Block Set up Time|Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity|Day one||||minutes||Inter-Quartile Range|Median
1304131|NCT03117140|Primary|Duration of Analgesia|Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off|1-3 days post-operative||||minutes||Inter-Quartile Range|Median
1304132|NCT03115853|Secondary|Difference in Mean Plasma Peak Aldosterone Levels||baseline to 18 weeks|data was lost and results are unknown||||||
1304133|NCT03115853|Secondary|Difference in Mean Changes in Plasma Renin Activity.||baseline to 18 weeks|||||||
1304134|NCT03115853|Secondary|Difference in Mean Plasma Aldosterone Levels||baseline to 18 weeks|||||||
1304135|NCT03115853|Primary|Difference in Mean Plasma PAI-1 Level||baseline to 18 weeks|data was lost and results are unknown||||||
1304136|NCT03115853|Primary|Difference in Peak Plasma PAI-1 Level||baseline to 18 weeks|data was lost and results are unknown||||||
1304137|NCT03115177|Primary|Bacterial Culture|Intraoperative cultures will be taken from all study participants and tested for detection of bacteria. These cultures were held for 14 days and tested for aerobic and anaerobic bacteria. Reported data are presented for the number of participants with a positive bacteria culture from the intraoperative samples.|2 weeks||||# Participants with Bacteria in Culture|||Number
1304138|NCT03114995|Secondary|Percentage of Participants With Periprocedural Myonecrosis|"Percentage of participants with periprocedural myonecrosis under the criteria described below.~When the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis."|0,6,12,18,24,30,36 hours||||Participants|||Count of Participants
1304139|NCT03114995|Primary|Area Under Curve of Serial Cardiac Biomarkers|An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours|0,6,12,18,24,30,36 hours||||Hours*ng/ml||Inter-Quartile Range|Median
1304140|NCT03110900|Primary|Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS)|Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available|120 minutes|No data was collected because the sponsor terminated the study before any data could be collected.||||||
1304141|NCT03109769|Primary|Change in Gingival Index|Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.|At baseline and after 4 weeks.||||units on a scale||Standard Deviation|Mean
1304142|NCT03109769|Primary|Change in Plaque Index|Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.|At baseline and after 4 weeks.||||units on a scale||Standard Deviation|Mean
1304143|NCT03106870|Secondary|Number of Participants With Neonates Who Were Hypoglycemic|Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery|24 hours after delivery||||Participants|||Count of Participants
1304144|NCT03106870|Secondary|Number of Participants With a Macrosomic Baby|Fetal macrosomia has been defined birth weight greater than 4500 gm|24 hours after delivery||||Participants|||Count of Participants
1304145|NCT03106870|Primary|Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation|"Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:~60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus"|from 20 weeks to 36 weeks gestation||||Participants|||Count of Participants
1304146|NCT03106337|Primary|Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)|Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.|Baseline (Day 0)|All enrolled participants.|||kPa||Standard Deviation|Mean
1304147|NCT03105518|Secondary|Amount of Discomfort Following Discharge Until Embryo Transfer|Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer.|After 1 hrs but less than 3 days|All 100 parturients analyzed; divided into those who had less than, compared to more than 10 follicles on preoperative ultrasound image.|||units on a scale||Standard Deviation|Mean
1304191|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after first intervention|||||||
1304192|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after third intervention|||||||
1304148|NCT03105518|Primary|Amount of Discomfort|Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.|PACU admission, 15, 30 and 60 min postprocedure|On PACU admission, subjects were divided into three groups based on the intensity of discomfort. A standardized postoperative analgesic regimen followed, based on VAS score and time (≤ or > than 30 min).|||units on a scale||Standard Deviation|Mean
1304149|NCT03099096|Secondary|Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 – Autoinjector With Standard Label Only|Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label has been presented. Only participants with data available at Week 4 were analyzed.|Week 4|All Subjects (Safety) Population|||Percentage of participants|||Number
1304150|NCT03099096|Secondary|Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 – Autoinjector With Standard Label + Pictogram|Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label + Pictogram has been presented. Only participants with data available at Week 4 were analyzed.|Week 4|All Subjects (Safety) Population|||Percentage of participants|||Number
1304151|NCT03099096|Primary|Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8 – Autoinjector With Standard Label Only|Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, Week 4, Week 8, and the End of Study Visit. Training on the study treatment, device handling and administration techniques was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). Only participants with data available at Week 8 were analyzed.|Week 8|All Subjects (Safety) Population|||Percentage of Participants|||Number
1304152|NCT03099096|Primary|Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8 – Autoinjector With Standard Label + Pictogram|Due to differences in the labelling requirements among regulatory authorities around the world, two different labelling approaches were included in this global study: labelling that includes a pictogram plus standard labelling elements, or a standard labelling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, 4, 8, and End of Study Visit. Training on the study treatment, device handling and administration technique was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). All Subjects (Safety) Population included all enrolled participants attempting at least one self-administration of mepolizumab. Only participants with data available at Week 8 were analyzed.|Week 8|All Subjects (Safety) Population|||Percentage of participants|||Number
1304153|NCT03098966|Secondary|Adverse Perinatal Outcomes|"• Adverse perinatal outcomes:~Apgar score~Neonatal Intensive Care Unit admission~Respiratory morbidity, e.g. transient tachypnoea of the newborn~Hypoxic ischaemic encephalopathy~Birth trauma~Mortality"|48 hours postpartum||||Participants|||Count of Participants
1304154|NCT03098966|Secondary|Number of Participants Who Had Maternal Morbidity|"• Maternal morbidity:~Uterine rupture~Surgical injuries (during emergency CS)~Hemorrhage and blood transfusion~Peripartum hysterectomy"|48 hours after onset of trial of labor||||Participants|||Count of Participants
1304155|NCT03098966|Primary|Number of Participants With Successful Vaginal Birth|Mode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).|24 hours after onset of trial of labor||||Participants|||Count of Participants
1304156|NCT03097614|Primary|Eye Dryness Score|Eye Dryness Score using a visual analog scale assessed in the CAE at Day 45|Day 45||||Score on Scale||Standard Error|Mean
1304157|NCT03091751|Primary|Mean Difference of Mean Residence Time (MRT): BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of mean residence time (MRT 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||hours||Standard Deviation|Mean
1304158|NCT03091751|Primary|Mean Difference of Clearance: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of clearance was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||mL/min x kg||Standard Deviation|Mean
1304193|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after second intervention|||||||
1305268|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb.||week95,108,120,144|intention to treat population|||percentage of paricipants|||Number
1304159|NCT03091751|Primary|Mean Difference of Terminal Half-Life: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of terminal half-life was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||hours||Standard Deviation|Mean
1304160|NCT03091751|Primary|Mean Difference of In Vivo Recovery: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of in vivo recovery was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||kg/dL||Standard Deviation|Mean
1304161|NCT03091751|Primary|Mean Difference of Area Under the Curve (AUC): BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of area under the curve (AUC 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||IU x hour/dL||Standard Deviation|Mean
1304162|NCT03090958|Secondary|Client Satisfaction Questionnaire Score|Acceptability of AllyQuest will be assessed using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 was used to assess global intervention satisfaction. The CSQ-8 has eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, effectiveness of app for dealing with health problem, overall satisfaction, and willingness to use the app again). These domains are assessed on a 4-point response scale with individually specified anchors. Participant responses are scored from 1 to 4, and thus the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction. The CSQ-8 has demonstrated high internal consistency across a large number of studies and has been used to evaluate technology-based interventions|4 weeks||||Scores on a scale||Standard Deviation|Mean
1304163|NCT03090958|Secondary|System Usability Scale Scores|Acceptability of AllyQuest will be measured by the System Usability Scale (SUS). An 11-item, 7-point Likert scale of subjective assessments of usability (1=strongly agree; 7=strongly disagree). The SUS is technology independent and provides a global measure of system satisfaction and sub-scales of usability and learnability.|4 weeks||||Scores on a scale||Standard Deviation|Mean
1304164|NCT03090958|Primary|Average Days Participants Logged Medications.|Feasibility of AllyQuest will be based on usage as measured by the average number of days participants logged their medications in the app.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||Days||Standard Deviation|Mean
1304165|NCT03090958|Primary|Average Number of App Actions by Participants|Feasibility of AllyQuest will be based on usage as measured by the average number of activities completed (daily quests), articles read, and social posts made.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||Activities completed||Standard Deviation|Mean
1304166|NCT03090958|Primary|Average Total Time in Minutes Participants Spent Using App.|Feasibility of AllyQuest will be based on usage as measured by the average time spent using app.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||Minutes||Standard Deviation|Mean
1304167|NCT03090958|Primary|Number of Individuals Who Enroll But do Not Participate|Feasibility of AllyQuest will be based on the number of individuals who enroll and do not participate.|4 weeks||||Participants|||Count of Participants
1304168|NCT03090958|Primary|Average Number of Days Participants Logged in.|Feasibility of AllyQuest will be based on usage as measured by the average number days participants access the app.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||days||Standard Deviation|Mean
1304169|NCT03090958|Primary|Number of Participants That Missed Follow up Interviews|Feasibility of AllyQuest will be based retention as measured by the number of missed follow up interviews. Follow up attempts will be documented.|4 weeks||||Participants|||Count of Participants
1304170|NCT03090958|Primary|Number of Participants That Were Enrolled of Those Screened|Feasibility of AllyQuest will be based on recruitment success as measured by the total number of individuals who are screened vs. the total number of individuals who are recruited and subsequently enrolled.|4 weeks|21 individuals were assessed for this outcome measure. The number analyzed were those that were recruited and screened for the study, but not enrolled.|||Participants|||Count of Participants
1304171|NCT03086447|Secondary|Monocular Distance Visual Acuity (VA)|Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet. Observed VA data collected at fitting were dichotomized whether VA was “20/20 or better (optimal VA)” or “worse than 20/20”. VA of 20/20 with a negative modifier was considered worse than 20/20. The number of eyes with 20/20 vision was reported for each study lens.|15 Minutes Post Lens Fitting|All subjects who have successfully completed all required visits without any major protocol deviations.|||Eyes|Number of Eyes||Number
1304172|NCT03086447|Secondary|Overall Handling|Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|Up to 4- Week Follow-up|All subjects who have successfully completed all required visits without any major protocol deviations.|||Units on a Scale||Standard Deviation|Mean
1304173|NCT03086447|Secondary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|Up to 4- Week Follow-up|All subjects who have successfully completed all required visits without any major protocol deviations.|||Units on a Scale||Standard Deviation|Mean
1304174|NCT03086447|Primary|Corneal Staining|Contact lens related corneal staining was assessed using slit lamp throughout the study. Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe. Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS). The number of eyes with Grade 3 or higher was reported for each lens type.|Up to 4-Week Follow-up|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
1304175|NCT03086447|Primary|Absolute Lens Rotation|Lens rotation was assessed using slit lamp with beam that can be rotated. The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation). The number of eyes with acceptable lens rotation for each lens was reported.|15-minutes Post Lens Insertion|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
1304176|NCT03086447|Primary|Lens Stability With Blink|Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated. The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability). The number of eye with acceptable stability was reported for each lens.|15 Minutes Post Lens Fitting|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
1304177|NCT03086447|Primary|Lens Fit Acceptance|Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness. Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic. The number of eyes with acceptable lens fit was reported for each study lens.|15 Minutes Post Lens Fitting|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
1304178|NCT03086447|Primary|Monocular Distance Visual Acuity (VA)|Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was “20/40 or better (acceptable VA)” or “worse than 20/40 (unacceptable VA)”. VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens.|Up to 4-Week Follow-up|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
1304179|NCT03083379|Primary|Regional Distribution of Ventilation|EIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.|2 months||||percentage of dorsal redistribution||Inter-Quartile Range|Median
1304180|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 min to 24 hours|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
1304181|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 90 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
1304194|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after first intervention|||||||
1304195|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after third intervention|||||||
1304196|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after second intervention|||||||
1306103|NCT02780622|Secondary|Terminal Half-life (t½) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||hours||Standard Deviation|Mean
1304182|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 60 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
1304183|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 30 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
1304184|NCT03072875|Primary|Number of ED Patient Participants Who Completed Semi-Structured Interview|"A semi-structured interview was conducted following use of the CAMS-RAS tool to assess users' likes, dislikes, and other preferences. Questions included: What were your experiences in using 'Dr. Dave' and the CAMS-RAS system? and What suggestions would you have for improvement? All subjects indicated that they found the tool helpful to them. They described the tool using adjectives similar to those used to describe Nurse Louise - a discharge nurse avatar on which the investigator's avatar was based: He's kind and asks me really practical, helpful questions; He speaks to me directly in a compassionate way; and He is kind and invested."|After interacting with the technology (length: approximately 1 hour), subjects were then asked to complete the semi-structured interview conducted by the research assistant. On average, the interview lasted approximately 15 minutes.|The qualitative information from the semi-structured interviews tells us subjects' general opinions and preferences concerning the avatar.|||Participants|||Count of Participants
1304185|NCT03072875|Primary|Usability Satisfaction and Acceptability Questionnaire (USAQ)|A brief face-valid, self-report measure that the PI derived from the System Usability Scale and has been successfully used in previous studies. Items are rated on a 5-point Likert Scale (1=poor; 3=good; 5=excellent). Includes open-ended questions to better understand what was most and least helpful with respect to each category and also measures users' acceptance.|up to one day|Suicidal ED Patients only|||units on a scale||Standard Deviation|Mean
1304186|NCT03072719|Secondary|Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, post first brushing (after 5 minutes), Day 3 and Day 14|Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively.|||gram (g)||Standard Deviation|Mean
1304187|NCT03072719|Secondary|Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, post first brushing (after 5 minutes) and Day 3|Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively.|||score on a scale||Standard Deviation|Mean
1304188|NCT03072719|Primary|Change From Baseline in Schiff Sensitivity Score on Day 14|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 14|Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively.|||score on a scale||Standard Deviation|Mean
1333301|NCT02043379|Secondary|Lactic Acid||pre-operative through 24 hours post-operative||||mmol/L||Standard Deviation|Mean
1304197|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after first intervention|||||||
1304198|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after third intervention|||||||
1304199|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after second intervention|||||||
1304200|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after first intervention|||||||
1304201|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after third intervention|||||||
1304202|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after second intervention|||||||
1304203|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after first intervention|||||||
1304204|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after third intervention|||||||
1304205|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after second intervention|||||||
1304206|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after first intervention|||||||
1304207|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after third intervention|||||||
1304208|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after second intervention|||||||
1304209|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after first intervention|||||||
1304210|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after third intervention|||||||
1304211|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after second intervention|||||||
1304212|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after first intervention|||||||
1304213|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after third intervention|||||||
1304214|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after second intervention|||||||
1304215|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after first intervention|||||||
1304216|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after third intervention|||||||
1304217|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after second intervention|||||||
1304218|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after first intervention|||||||
1304219|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after third intervention|||||||
1304220|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after second intervention|||||||
1304221|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after first intervention|||||||
1304222|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after third intervention|||||||
1304223|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after second intervention|||||||
1304224|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after first intervention|||||||
1304225|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|2 weeks after second intervention|||||||
1304226|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|2 weeks after first intervention|||||||
1304227|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|up to 3 days after randomization|||||||
1304228|NCT03070730|Primary|Change Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|2 weeks after second intervention|||||||
1304229|NCT03070730|Primary|Change Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|2 weeks after first intervention|||||||
1304230|NCT03070730|Primary|Change in Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|Up to 3 days after randomization|||||||
1304231|NCT03069313|Secondary|Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).|Inflammatory markers were measured pre and post treatment.|Baseline and at 90 days (+/- 10 days)|postmenopasual women receiving AI|||Percentage change||Standard Deviation|Median
1304232|NCT03069313|Secondary|Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)|All of the items in this questionnaire have a 5 scale rating, from not at all (0) to very much (4). Outcomes were measured pre and post treatment. Version 4 of the FACT-ES contains 3 subscales with seven questions: Physical Well-Being (PWB) (score range 0-28), Functional Well-Being (FWB) (score range 0-28), and Social and Well-Being (SWB) (score range 0-28); Emotional Well-Being (EWB) (score range 0-24) with six questions, and the Endocrine Symptom Subscale (ESS) (score range 0-76) containing 19 questions. For all subscale a higher score represents better quality of life.|Baseline and 90 days (+/- 10 days)|postemneopausal women with ER + , Stages I-III breast cancer|||Percentage change||Standard Deviation|Mean
1304233|NCT03069313|Secondary|Percentage Change in Worst Pain at the End of Treatment .|"Analysis of the data collected at baseline and at the end of treatment in the BPI-SF questionnaire. The Brief Pain Inventory - Short Form (BPI- SF) worst pain score used. This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine. Participants were asked to rate worst pain an average pain within the last 24 hours."|Baseline and 90 days (+/- 10 days)|Postmenopausal women with ER+ breast cancer, stages I-III on aromatase inhibitors and musculoskeletal pain (average pain level > or=4 using BPI-SF)|||Percentage change||Standard Deviation|Mean
1304234|NCT03069313|Primary|Percentage Change in Average Joint Pain in Women With Aromatase Inhibitor-associated Musculoskeletal Symptoms (AIMSS) Compared to Baseline as Measured by the Brief Pain Inventory Short Form (BPI-SF).|"The Brief Pain Inventory – Short Form (BPI- SF) average pain score used. This item has a scale of 0 to 10 with 0 indicating “No pain” and 10 indicating “Pain as bad as you can imagine We expect at least 20% improvement in BPI-SF pain scores. Participants were asked to rate worst pain an average pain within the last 24 hours."|Baseline and 90 days (+/- 10 days)|A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study.|||Percentage change||Standard Deviation|Mean
1304235|NCT03065933|Primary|Score on a Mania Rating Scale|Mania rating scale to be performed each day of this 3 day study.|3 days|No data was collected on the 5 participants, except for region of enrollment, before the study terminated.||||||
1304236|NCT03061513|Secondary|Cerebral Redox Markers|Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy|at baseline and 8 weeks||||Ratio||Standard Deviation|Mean
1304237|NCT03061513|Primary|Number of Adverse Events|The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.|at 24 weeks|ITT|||Number of Adverse Events|||Number
1304238|NCT03060512|Secondary|Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms|"The BFI is a 3-item questionnaire administered by a study clinician to measure constipation from the subject's perspective (ease of defecation, feeling of complete evacuation, and personal judgment of constipation). For each item the subject was asked to rate their response on a scale from 0 to 100, where 0 indicates the best response (easy/no diffculty) and 100 the worst response (severe difficulty). The total BFI score was calculated as the mean of the 3 item scores.~The mean change from baseline in BFI scores at Visits 3 and/or 5 are presented."|From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36).|The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing BFI data at the end of at least one of the two week treatment periods.|||Score||Standard Deviation|Mean
1304239|NCT03060512|Secondary|PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms|"PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The subjects selected one of the following PGIC items as their response: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real differences; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms.~The number of subjects responding to each PGIC item at Visits 3 and/or 5 is presented for each treatment overall."|At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.|The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods.|||Participants|||Number
1304240|NCT03060512|Secondary|Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms|"PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The scoring was as follows: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms.~Mean score results are presented for each treatment for Visits 3 and 5."|At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.|The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods.|||Score||Standard Deviation|Mean
1309223|NCT02614924|Primary|Total Time Taken to Complete the Procedure of Awake Intubation||up to 20 minutes||||seconds||Inter-Quartile Range|Median
1304241|NCT03060512|Secondary|Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350|"In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the number of subjects in each characteristic category is presented for the overall PP Set according to which treatment was preferred.~The assessment was only completed by subjects who indicated an overall preference."|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.|||Participants|||Count of Participants
1304242|NCT03060512|Secondary|Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350|"In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the median score for each characteristic is presented for the overall PP Set according to which treatment was preferred.~The assessment was only completed by subjects who indicated an overall preference."|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.|||Score||Full Range|Median
1304243|NCT03060512|Primary|Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence|The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Strong preference for PEG 3350, Moderate preference for PEG 3350 and Slight preference for PEG 3350. Preference for Period 1 treatment and Preference for Period 2 treatment included subjects who preferred the first and second treatments respectively taken within a given treatment sequence. The number of subjects in each category is presented per treatment sequence for subjects in the PP Set.|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important important protocol deviation.|||Participants|||Count of Participants
1304244|NCT03060512|Primary|Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment|The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set.|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.|||Participants|||Count of Participants
1304245|NCT03057704|Secondary|Investigators Rating of Patient Discomfort|"Investigator rates patient's nonverbal display of discomfort.~Investigator Assessments:~Induction Discomfort Scale (during injection and within 5 seconds after injection)~No change in patient behavior (0)~Grimace (1)~IV forearm withdrawal (2)~Moaning (3)~Verbal statement of discomfort (“it hurts”, etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced."|During injection at beginning of study period; lasts 10 seconds one time only||||units on a scale||Standard Deviation|Mean
1304246|NCT03057704|Secondary|Subject's Recall of Injection Discomfort|"Investigator asks patient if they recall discomfort during injection after the procedure.~Patient's verbal rating and recall of pain during injection.~We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:~How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:~None (0)~Mild (1)~Moderate (2)~Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome)."|This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only||||units on a scale||Standard Deviation|Mean
1304247|NCT03057704|Primary|Patient Expression of Pain|"Patient's verbal rating of pain during injection (see link to study protocol)~We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:~How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:~None (0)~Mild (1)~Moderate (2)~Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome)."|During injection at beginning of study; lasts 10 seconds one time only||||units on a scale||Standard Deviation|Mean
1304294|NCT03050294|Secondary|Total Lesion Severity Score- Atopic Dermatitis|The total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.|1 week||||units on a scale||Standard Deviation|Mean
1304248|NCT03056352|Secondary|Number of Participants Satisfied With Medication; Assessed by Self-evaluation|"Satisfaction is measured by a positive response to the question Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"|48 hours after treatment|2 patients did not provide an answer to this question|||Participants|||Count of Participants
1304249|NCT03056352|Secondary|Post Concussion Symptoms Assessed by Post-concussive Symptom Scale|The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.|7 days|2 patients were lost to followup|||units on a scale||Standard Deviation|Mean
1304250|NCT03056352|Primary|Number of Participants With Sustained Headache Relief|"Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration."|2 hours thru 48 hours after treatment||||Participants|||Count of Participants
1304251|NCT03055221|Primary|Effect of Long-term Remodulin Therapy on the NYHA Functional Classification|The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).|The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit|Data presented include all subjects who underwent an NYHA functional classification assessment at their final visit. Not all subjects underwent an NYHA assessement at their final visit.|||Functional Class||Standard Deviation|Mean
1304252|NCT03055221|Primary|Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)|The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.|The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit|Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit.|||Meters||Standard Deviation|Mean
1304253|NCT03054857|Secondary|ICU Stay in Hours||7 days||||hours||Standard Deviation|Mean
1304254|NCT03054857|Secondary|Hospital Stay in Days||30 days||||days||Standard Deviation|Mean
1304255|NCT03054857|Secondary|Number of Participants With Postoperative Complications|Neurological complication, Delirium, dysrhythmia, death|7 days||||Participants|||Count of Participants
1304256|NCT03054857|Primary|Number of Participants With Postoperative Cognitive Dysfunction (POCD)|POCD was defined as a decline of 1SD of baseline score in either MoCA test or short bless test.|7 days||||Participants|||Count of Participants
1304257|NCT03054857|Primary|Numbers of Participants With Postoperative Cognitive Dysfunction (POCD)|POCD was defined as a decline of 1 standard-deviation (1SD) of baseline score in either MoCA test or short bless test.|48 hours||||Participants|||Count of Participants
1304258|NCT03054103|Secondary|Nausea|Self-reported incidence of nausea. This will be assessed by asking the subjects once (just prior to discharge from the PACU) whether they experienced any nausea while they were in the PACU (Recovery Room) and will be a measurement of the count of participants that experienced nausea during this period|This will occur from time of entry into PACU to time of departure after their surgery. (One time only, in a range of 20 to 30 minutes after surgery.||||Participants|||Count of Participants
1304259|NCT03054103|Secondary|PACU Length of Stay|This is obtained from the records as time spent in the PACU (Recovery Room) after surgery.|This will occur one time only, in a range of 20 to 30 minutes after the surgery is completed.||||Minutes||Standard Deviation|Mean
1304260|NCT03054103|Secondary|Measure of Comfort (See Link to Study Protocol for Scale)|Measure of comfort (0-3; 0=very comfortable to 3=extremely uncomfortable|Obtained on the first day after surgery during the subject's routine postoperative check in the Ophthalmology Clinic.||||units on a scale||Standard Deviation|Mean
1304261|NCT03054103|Primary|Eye Mobility During Surgery (See Link to Study Protocol for Scale)|Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).|Intraoperative, end of operation reported||||units on a scale||Standard Deviation|Mean
1304262|NCT03054077|Primary|Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2|"The Modified Yale Preoperative Anxiety Scale- Short form (mYPAS-SF) Ratings produce 4 mYPAS scores (1 for each time point)~Areas scored:~Activity (1,2,3, or 4) Vocalizations (1,2,3,4,5,or 6) Emotional Expressivity (1,2,3, or 4) State of Apparent arousal (1,2,3, or 4) Scoring: Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the “vocalizations” item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100.~This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.~Comparison of scores between Group 1 and Group 2 to see if changes in anxiety scores occurred with the addition of the iPad.~All data will be gathered with review at the close of the study which is anticipated to occur in 5/20/2017."|Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes|All participants for whom 3 time points were collected at Baseline T1, T2, and T3|||units on a scale||95% Confidence Interval|Least Squares Mean
1304263|NCT03052530|Secondary|Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)|Clinically Significant Arrhythmias (requiring intervention)|Endpoint will be measured through hospital discharge (expected to be within 24 hours)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
1304264|NCT03052530|Secondary|Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel|In-hospital stent thrombosis (ST) within the target vessel|Endpoint will be measured through hospital discharge (expected to be within 24 hours)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
1304265|NCT03052530|Secondary|Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)|"In-hospital Major Adverse Cardiac Events (MACE)~All death (cardiac and non-cardiac)~Myocardial infarction (MI)~Target Lesion Revascularization (TLR)"|Endpoints will be measured through hospital discharge (expected to be within 24 hours)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
1304363|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Glucose (Glu)|When venous blood are collected, glucose levels are measured immediately by Glucometer.|up to 48h after surgery||||mmol/L||Standard Deviation|Mean
1304266|NCT03052530|Primary|Number of Participants With Device Procedural Success|"Device procedural success consisting of the following:~Successful delivery, inflation, deflation and withdrawal of the study balloon~No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon~Final TIMI flow grade of 3 at the conclusion of the PCI procedure"|Peri-procedural (at Day 0)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
1304267|NCT03050775|Secondary|Estimated Blood Loss|The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used.|duration of surgery|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||milliters||Inter-Quartile Range|Median
1304268|NCT03050775|Secondary|Number of Participants With Transfusion Within 48 Hours of Surgery|Requirement of blood transfusion within 48 hours of surgery|Within 48 hours of surgery|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||Participants|||Count of Participants
1304269|NCT03050775|Secondary|Overall Post-operative Temperature|Temperature at Post Anesthesia Care Unit (PACU) arrival.|PACU arrival|"One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.~Data was obtained from 32 subjects in the treatment group."|||degrees Celsius||Standard Deviation|Mean
1304270|NCT03050775|Secondary|Hospital Length of Stay|Number of days in the hospital|Surgery to hospital discharge|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||number of days||Inter-Quartile Range|Median
1304271|NCT03050775|Secondary|Number of Subjects With Post-operative Shivering|Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis.|Approximately 2 hours after completion of the surgery|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||Participants|||Count of Participants
1304272|NCT03050775|Secondary|Intraoperative Core Temperatures Post-induction|Core body temperature will be taken in the esophagus after general anesthesia induction.|Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia|"One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.~Data was obtained from 33 subjects in the treatment group at 60 minutes post-induction."|||degrees Celsius||Standard Deviation|Mean
1304273|NCT03050775|Primary|Core Body Temperature|Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.|Approximately four hours post-induction of general anesthesia (or last recorded temperature)|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||degrees Celsius||Standard Deviation|Mean
1304274|NCT03050541|Secondary|Probability of Accurately Recognizing Visual Stimuli|"After the cued recollection task, all of the pictures were presented to participants (i.e., the ones that they had seen, as well as the ones that were not seen). Participants were then asked, Did you see this picture? Hit and false alarm rates were calculated, and memory accuracy was measured as hits minus false alarms."|90 minutes into Session 2||||probability||Standard Deviation|Mean
1304275|NCT03050541|Primary|Probability of Accurately Recalling Visual Stimuli|"During encoding, participants were presented with labels that were sometimes followed by pictures. During the first memory test, participant were presented again with all of the labels and asked, Did you see this picture? Hit and false alarm rates were then calculated, and memory accuracy was measured by hits minus false alarms."|90 minutes into Session 2||||probability||Standard Deviation|Mean
1304276|NCT03050320|Secondary|Change in Arthritis-related Self-Efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
1304277|NCT03050320|Secondary|Change in Depressive Symptoms|Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
1304278|NCT03050320|Secondary|Change in Work Ability|The Work Ability Index (WAI) is a widely-used self-report questionnaire that evaluates a worker's capacity to perform a job accounting for their physical and mental well-being in addition to the demands of their job. The WAI consists of seven dimensions including current work ability relative to life-time best, work ability related to job demands, number of current physician-diagnosed health conditions, estimated work impairment due to the conditions, sick leave over the past year, own prognosis, and mental resources. Total scores range from 7 to 49 and can fall under one of four classifications: poor work ability that should be restored (7-27), moderate work ability that should be improved (28-36), good work ability that should be supported (37-43), and excellent work ability that should be maintained (44-49). The WAI produces reliable data.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
1304391|NCT03032965|Secondary|Incidence of Death|Number of deaths within 90 days of the procedure.|with 90 days of the procedure||||Participants|||Count of Participants
1309913|NCT02588976|Secondary|Glass Bead Activated Clotting Time||Routine measurements during cardiac surgery||||seconds||Standard Deviation|Mean
1304279|NCT03050320|Secondary|Change in Resilience|Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
1304280|NCT03050320|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Number of chair stands||Standard Deviation|Mean
1304281|NCT03050320|Secondary|Change in Mobility Performance (Stair Ascent and Descent)|Mobility performance will be measured using the Stair Ascent and Descent Test. For this test, the time taken to ascend, as well as descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Seconds||Standard Deviation|Mean
1304282|NCT03050320|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Meters||Standard Deviation|Mean
1304283|NCT03050320|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.|Weeks 1 and 13||||mL/kg/min||Standard Deviation|Mean
1304284|NCT03050320|Secondary|Change in Grip Strength|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.|Weeks 1 and 13||||Kg of force||Standard Deviation|Mean
1304285|NCT03050320|Secondary|Change in Isometric Knee Extensor and Flexor Strength|The peak torque developed during knee extension and flexion during a maximum isometric contraction will be measured by use of a ergoFET hand-held dynamometer.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Newton*meters/kg||Standard Deviation|Mean
1304286|NCT03050320|Secondary|Change in Self-reported Upper Extremity Pain|The Disabilities of the Arm Shoulder and Hand is a 30-item questionnaire addressing upper extremity physical function and symptoms. The DASH is suitable for people with any upper limb musculoskeletal disorders and can also monitor changes in severity of symptoms and functional abilities over time. Each item is scored from 1 (no difficulty) to 5 (unable). Total scores range from 0 to 100, with higher scores indicating more upper limb problems.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
1304287|NCT03050320|Secondary|Change in Self-reported Knee and Hip Pain|Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
1304288|NCT03050320|Primary|Change in Lower Extremity Functional Scale|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
1304289|NCT03050294|Secondary|Psoriasis Area and Severity Index|The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected areas (head, arms, trunk, and legs). The severity of three clinical signs (erythema, induration and desquamation) are on a scale from 0 to 4 (from absent to very severe). An area and severity score for each region is calculated by multiplying the area score by the severity score. The score range is 0-72, with higher scores denoting worse outcomes.|2 weeks||||units on a scale||Standard Deviation|Mean
1304290|NCT03050294|Secondary|Pruritus Visual Analog Scale- Psoriasis|The Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents “no itch” (score of 0) and the right end point the “worst imaginable itch” (score of 10).|2 weeks||||units on a scale||Standard Deviation|Mean
1304291|NCT03050294|Secondary|Pruritus Visual Analog Scale- Atopic Dermatitis|The Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents “no itch” (score of 0) and the right end point the “worst imaginable itch” (score of 10).|1 week||||units on a scale||Standard Deviation|Mean
1304292|NCT03050294|Secondary|Eczema Area and Severity Index- Atopic Dermatitis|Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.|1 week||||units on a scale||Standard Deviation|Mean
1304293|NCT03050294|Secondary|Total Lesion Severity Score-Psoriasis|The total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.|2 weeks||||units on a scale||Standard Deviation|Mean
1304295|NCT03050294|Primary|Investigator Global Assessment- Psoriasis|Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease|2 weeks||||units on a scale||Standard Deviation|Mean
1304296|NCT03050294|Primary|Investigator Global Assessment- Atopic Dermatitis|Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease|1 week||||units on a scale||Standard Deviation|Mean
1304297|NCT03048383|Secondary|Adverse Events|We hypothesized that common minor events such as bruising and swelling at injection sites would occur equally for all treatment arms, but that no major adverse treatment effects would occur for any of the treatment arms. Major events are recorded here.|Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.||||Adverse Events|||Number
1304298|NCT03048383|Primary|Change in Synkinesis Assessment Questionnaire (SAQ) Scores|"The previously validated instrument, Synkinesis Assessment Questionnaire (SAQ), was administered in order to evaluate patient-perceived severity of synkinesis. This instrument was used for each of the three treatment arms and change in scores from baseline were compared at each time point between arms.~SAQ scores are calculated as the sum of scores for 9 questions, which each is scored from 1 to 5, divided by 45 and multiplied by 100. The total score therefore can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe. We report here the mean total SAQ score each group. For additional information on the SAQ for facial synkinesis see Mehta et al. published in Laryngoscope in May 2007 (PMID: 17473697)."|Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.|The Synkinesis Assessment Questionnaire (SAQ) was used to assess severity of facial synkinesis for each group. Total SAQ scores can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe.|||units on a scale||Standard Deviation|Mean
1304299|NCT03048058|Secondary|Dermatology Life Quality Index|Dermatology Life Quality Index (DLQI) for the impact of rosacea on everyday activities. The score range is 0-30 with higher scores having a larger effect on patient's life.|baseline and 6 months|No data was collected||||||
1304300|NCT03048058|Secondary|Quality of Life With Rosacea|Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
1304301|NCT03048058|Secondary|Patient Severity Assessment (PSA)|Patient Severity Assessment: Subject ratings of erythema with scale 0 - 4. 0 = face free of rosacea; 4 = My face has severe medium to large sized red inflamed bumps or pustules, My face has severe redness. Higher scores denotes worse outcomes.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
1304302|NCT03048058|Secondary|Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)|Change in overall Quality of Life as measured by the The Life Impact Survey. This measures the impact of rosacea and its treatment on life. The score range is 0-54 with higher scores denoting worse outcomes.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
1304303|NCT03048058|Secondary|Clinician Erythema Assessment Scale|Clinician Erythema Assessment scale based on scale of 0-4 with 0 being no erythema and 4 being severe erythema with greater scores denoting a worse outcome.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
1304304|NCT03048058|Secondary|Lesion Count|Reduction in total Lesion count|Baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||count of lesions||Standard Deviation|Mean
1304305|NCT03048058|Primary|Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)|To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject|6 months||||percentage of medication use||Standard Deviation|Median
1304306|NCT03048006|Secondary|Image Quality|"Image quality was evaluated with a 5-step scale from excellent to very poor (excellent/very good; good; moderate; poor and very poor)"|During MRI procedure|Image quality was missing for 108 patients.|||Participants|||Count of Participants
1304307|NCT03048006|Secondary|Diagnostic Value|"Diagnostic value was evaluated by answering yes or no to the following question Were you able to make a diagnosis based on the test results ?"|During MRI procedure|Diagnostic value was missing for 77 patients.|||Participants|||Count of Participants
1304308|NCT03048006|Primary|Frequency of Adverse Events|The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.|From the beginning of the MRI procedure to 30–60 min after||||adverse events|||Number
1304309|NCT03047447|Secondary|Ketones (Blood)|Ketones (blood) were measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for ketones (blood) at week 10 minus ketones (blood) at week 0.|10-weeks||||mmol/L||95% Confidence Interval|Mean
1304310|NCT03047447|Secondary|Body Fat Mass (Pounds of Body Fat)|BFM (body fat mass) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BFM at week 10 minus BFM at week 0.|10-weeks||||pounds||95% Confidence Interval|Mean
1304311|NCT03047447|Secondary|BMI (Body Mass Index)|BMI (body mass index) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BMI at week 10 minus BMI at week 0.|10-weeks||||kg/m^2||95% Confidence Interval|Mean
1304392|NCT03032965|Secondary|Incidence of Atrio-esophageal Fistula|Number of subjects who develop connection between heart and the esophagus|within 4 weeks||||Participants|||Count of Participants
1304312|NCT03047447|Secondary|Weight|Weight was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for weight at week 10 minus weight at week 0.|10-weeks||||pounds||95% Confidence Interval|Mean
1304313|NCT03047447|Primary|Hemoglobin A1c|Hemoglobin A1c (HgA1c) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for HgA1c at week 10 minus the HgA1c value at week 0.|Week 0 - Week 10||||% of hemoglobin||95% Confidence Interval|Mean
1304314|NCT03046225|Secondary|Change in Knee Range of Motion From Baseline to 30 Minutes|It was extracted from the continuous passive movement device display. During the use of the continuous passive movement device (CPM), from the observation of the digital display in its control, the degrees of amplitude reached in the passive movements of flexion and extension of the knee submitted to the surgery were extracted.|30 minutes||||Degrees||Standard Deviation|Mean
1304315|NCT03046225|Secondary|Number of Participants Who Received Morphine Within 24 Hours|It was evaluated based on the information found in patients' electronic records, considering whether they received morphine during the 24 hours following the interventions or not.|24 hours||||Participants|||Number
1304316|NCT03046225|Primary|Change in Pain Level From Baseline to 90 Minutes|It was measured by Visual Analogue Pain Scale (VAS), which has scores ranging from zero (which means “no pain”) to 10 (which means “worst possible pain”). Two evaluations of the pain level were performed in each group, before and after the interventions.|90 minutes||||Units on a scale||Standard Deviation|Mean
1304317|NCT03046212|Secondary|Number of Participants Who Received Morphine Within 24 Hours|It was evaluated based on the information found in patients' electronic records, considering whether they received morphine during the 24 hours following the interventions or not.|24 hours||||participants|||Number
1304318|NCT03046212|Secondary|Change in Hip Range of Motion From Baseline to 45 Minutes|Flexion and abduction movements were assessed by goniometry in the hip submitted to the surgery. Two evaluations were performed in each group, before and after the interventions.|baseline, 45 minutes||||degrees||Standard Deviation|Mean
1304319|NCT03046212|Primary|Change in Pain Level From Baseline to 45 Minutes|It was measured by Visual Analogue Pain Scale (VAS), which has scores ranging from zero (which means “no pain”) to 10 (which means “worst possible pain”). Two evaluations were performed in each group, before and after the interventions.|baseline, 45 minutes||||units on a scale||Standard Deviation|Mean
1304320|NCT03044431|Other Pre-specified|Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for ILD pre-treatment and then at 6 months post-treatment|23 patients with ILD completed a 6 month post-treatment QOL survey|||Participants|||Count of Participants
1304321|NCT03044431|Other Pre-specified|Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for ILD pre-treatment and then at 3 months post-treatment|28 patients with ILD completed a 3 month post-treatment QOL survey|||Participants|||Count of Participants
1304322|NCT03044431|Other Pre-specified|Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for COPD pre-treatment and then at 6 months post-treatment|101 patients with COPD completed a 6 month post-treatment QOL survey|||Participants|||Count of Participants
1304323|NCT03044431|Other Pre-specified|Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for COPD pre-treatment and then at 3 months post-treatment|120 patients with COPD completed a 3 month post-treatment QOL survey|||Participants|||Count of Participants
1304324|NCT03044431|Primary|Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses|Number of patients in the total sample who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements pre-treatment and then at 6 months post-treatment among all diagnoses|124 patients completed a 6 month post-treatment QOL survey|||Participants|||Count of Participants
1304325|NCT03044431|Primary|Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses|Number of patients in the total sample who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements pre-treatment and then at 3 months post-treatment for all diagnoses|148 of 207 enrolled participants completed the 3 month post-treatment QOL survey|||Participants|||Count of Participants
1304326|NCT03044431|Primary|Change in FEV1 From Baseline Among COPD Patients|Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment|Measurements pre-treatment and then at 6 months post- treatment|All patients with COPD were asked to provide a 6 month post-treatment pulmonary function test. 5 participants completed and returned the test.|||percentage of change in FEV1||Full Range|Mean
1304327|NCT03043534|Secondary|Mechanics of Shaving|"A total of the Patient’s Global Assessment of mechanics of shaving based on following scale:~How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)~A) get a smooth shave after shaving? __________~B) shave stubborn hairs? __________~C) shave against the grain with little irritation? __________~D) shave with the grain with little irritation? __________~E) glide comfortably over your skin with the razor blade?~For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics"|6 weeks||||units on a scale||Standard Deviation|Mean
1304393|NCT03032965|Secondary|Incidence of Cardiac Perforation|Number of subjects who develop perforation of heart during ablation|within 24 hours||||Participants|||Count of Participants
1304328|NCT03043534|Primary|Patient Global Severity|"Patient’s Global Severity Assessment (Degree of Itching, Burning and Stinging) based on the following scale:~Please indicate how much immediate post shave itching/burning/stinging you are experiencing at this time on a scale of 1 to 5 (circle one):~= No itching/burning/stinging at all~= Mild or minimal itching/burning/stinging~= Moderate itching/burning/stinging~= Severe itching/burning/stinging~= Very severe (maximum itching/burning/stinging)"|6 weeks||||units on a scale||Standard Deviation|Mean
1304329|NCT03041298|Primary|Frequency of Adverse Drug Reactions|The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.|From the beginning of the MR mammography procedure to 30-60 min after||||Adverse drug reactions|||Number
1304330|NCT03041298|Primary|Cytology Test Results (Percentage of Patients Per Cytology Test Result)|Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.|During MRI procedure|A cytology test was performed in 232 patients.|||Participants|||Count of Participants
1304331|NCT03041298|Primary|Diagnostic Results (Percentage of Patients Per Diagnosis)|Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.|During MRI procedure|Diagnosis was achieved in 1523 patients but results were missing for 4 patients.|||Participants|||Count of Participants
1304332|NCT03041298|Primary|Ability to Make a Diagnosis|"Ability to make a diagnosis was evaluated by answering yes or no to the question Did the examination permit a diagnosis ?"|During MRI procedure|Ability to make a diagnosis was missing for 2 patients.|||Participants|||Count of Participants
1304333|NCT03041298|Primary|Image Quality|"Image quality was evaluated on a 5-point scale: excellent; good; moderate; poor and very poor."|During MRI procedure|Image quality was missing for 16 patients.|||Participants|||Count of Participants
1304334|NCT03039543|Secondary|Other Postoperative Adverse Events|Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort|During PACU stay (An average of 15 minutes)|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||Participants|||Count of Participants
1304335|NCT03039543|Secondary|the Incidence of Desaturation|Respiratory complication such as desaturation (SpO2 < 90%) were recorded during PACU stay.|During PACU stay (An average of 15 minutes)|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||Participants|||Count of Participants
1304336|NCT03039543|Secondary|Recovery Time (PACU Discharge)|time needed to reach a modified Aldrete score of 9|During PACU stay (An average of 15 minutes)|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||minutes||Standard Deviation|Mean
1304337|NCT03039543|Secondary|Incidence of Postoperative Residual Curarization|the number of participant with Postoperative residual curarization (PORC, TOF ratio < 0.9 )|at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||Participants|||Count of Participants
1304338|NCT03039543|Primary|Number of Participants Attaining a 5 (Optimal) Surgical Condition Score|"5-point surgical condition scale was evaluated as follows.~Extremely poor~unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.~Poor~severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.~Acceptable~a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon’s work. There is the need for additional NMB to prevent deterioration.~Good~a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.~Optimal~a wide endoscopic working field without any movement or contractions. No additional NMB is needed."|immediately following the operation, an average of 5 minutes||||Participants|||Count of Participants
1304339|NCT03039179|Secondary|"Pain (Score on the Numeric Rating Scale)"|"Pain Score on the Numeric Rating Scale > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain."|up to the first 3 days post intervention||||Participants|||Count of Participants
1304340|NCT03039179|Primary|Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)|Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.|every day until discharge (expected average of 3 days)||||Participants|||Count of Participants
1304341|NCT03037905|Other Pre-specified|Analgesic Use|Number of people requiring analgesia in the post-anesthesia care unit|Postoperatively|Patients that have undergone thyroid and/or parathyroid surgery|||Participants|||Count of Participants
1304342|NCT03037905|Secondary|Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates|Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit|Pre-operative to post-operative|Patients undergoing thyroid and/or parathyroid surgery|||beats per minute||95% Confidence Interval|Mean
1304394|NCT03032965|Secondary|Incidence of Pulmonary Vein Stenosis|Number of subjects who develop Symptomatic pulmonary vein stenosis|6 months post-procedure||||Participants|||Count of Participants
1304343|NCT03037905|Secondary|Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures|Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit|Pre-operative to post-operative|Patients undergoing thyroid and/or parathyroid surgery|||mm Hg||95% Confidence Interval|Mean
1304344|NCT03037905|Primary|Change (Difference) in Anxiety|"Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors No anxiety to The most anxiety I can imagine. Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety."|Pre-operatively to post-operatively|thyroid and/or parathyroid surgery patients|||units on a scale||95% Confidence Interval|Mean
1304345|NCT03037541|Secondary|Number of Participants With 75% Clearance|The secondary endpoint is number of participants that receive 75 % clearance of|24 weeks||||Participants|||Count of Participants
1304346|NCT03037541|Primary|Number Participants With 100% Clearance|The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment|24 weeks||||Participants|||Count of Participants
1304347|NCT03037307|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|Up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy.|||lbs||Standard Error|Least Squares Mean
1304348|NCT03037307|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|Up to 12 hours|Analysis for this outcome was performed on intention-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy.|||lbs||Standard Error|Least Squares Mean
1304349|NCT03036215|Secondary|Graded Chronic Pain Interference|Assessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.|Change from baseline to 16 weeks post intervention||||units on a scale||Standard Deviation|Mean
1304350|NCT03036215|Primary|Assessing Change in Jaw Functioning|Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)|Change from baseline to 16 weeks post intervention||||units on a scale||Standard Deviation|Mean
1304351|NCT03036215|Primary|Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program|Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)|Change from baseline to 16 weeks post intervention||||units on a scale||Standard Deviation|Mean
1304352|NCT03035955|Primary|Demodex Count|number of demodex at Baseline and Week 4. Only Week 4 reported|Week 4||||number of demodex|||Number
1304353|NCT03035916|Secondary|Side Effects: Number of Participants With Vomiting|The state of vomiting was evaluated after surgery during first postoperative 48 hours.|up to 48h after surgery||||participants|||Number
1304354|NCT03035916|Secondary|Side Effects: Number of Participants With Nausea|The state of nausea was evaluated after surgery during first postoperative 48 hours.|up to 48h after surgery||||participants|||Number
1304355|NCT03035916|Secondary|Side Effects: Number of Participants With Sedation|The state of sedation was evaluated after surgery during first postoperative 48 hours.|up to 48h after surgery||||participants|||Number
1304356|NCT03035916|Secondary|Anesthesia Recovery: Number of Participants With Prolonged Hospitalization|The percentage of long hospitalization were measured. More than 7 days after surgery is defined as prolonged hospitalization.|Through study completion, an average of 2 weeks||||participants|||Number
1304357|NCT03035916|Secondary|Anesthesia Recovery: the Time of First Flatus|The time of first flatus was measured after surgery.|Through study completion, an average of 2 weeks||||hour||Standard Deviation|Mean
1304358|NCT03035916|Secondary|Questionnaire: Pain Scores on Movement|Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.|1hr, 6hr, 12hr, 24hr, and 48hr after surgery||||units on a scale||Standard Deviation|Mean
1304359|NCT03035916|Secondary|Questionnaire: Pain Scores at Rest|Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.|1hr, 6hr, 12hr, 24hr, and 48hr after surgery||||units on a scale||Standard Deviation|Mean
1304360|NCT03035916|Secondary|Anesthetics Consumption: Sufentanil Consumption|Intraoperative superaddition of sufentanil was measured.|during operation||||ug||Standard Deviation|Mean
1304361|NCT03035916|Primary|Hemodynamic Parameters: Mean Arterial Pressure(MAP)|Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)＝ (systolic blood pressure＋2×diastolic blood pressure)/3|up to 48h after surgery||||mmHg||Standard Deviation|Mean
1304362|NCT03035916|Primary|Hemodynamic Parameters: Heart Rate.|Continuous monitoring of heart rate to 48 hours after surgery.|up to 48h after surgery||||bpm||Standard Deviation|Mean
1304364|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Cortisol (Cor)|Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.|up to 48h after surgery||||mmol/L||Standard Deviation|Mean
1304365|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Epinephrine (E)|Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.|up to 48h after surgery||||pg/ml||Standard Deviation|Mean
1304366|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Norepinephrine (NE)|Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.|up to 48h after surgery||||pg/ml||Standard Deviation|Mean
1304367|NCT03034954|Secondary|Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304368|NCT03034954|Secondary|Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304369|NCT03034954|Secondary|Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304370|NCT03034954|Secondary|Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304371|NCT03034954|Secondary|Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304372|NCT03034954|Secondary|Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304373|NCT03034954|Secondary|Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304374|NCT03034954|Secondary|Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304375|NCT03034954|Secondary|Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304376|NCT03034954|Secondary|Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
1304377|NCT03034954|Secondary|Blinding in Total Sample|Participants were asked to estimate which group they were in (i.e., active or sham).|~1 minute post stimulation||||Participants|||Count of Participants
1304378|NCT03034954|Primary|Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')|The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.|30 minutes post-stimulation|missing data for two participants|||d'||Standard Deviation|Mean
1304379|NCT03034954|Primary|Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')|The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.|30 minutes post-stimulation|missing data for 12 participants: 11 2-back (5 Active; 6 sham) due to Eprime miscalculation & one 0-back (Active)|||d'||Standard Deviation|Mean
1304395|NCT03032965|Secondary|Incidence of Stroke|Number of subjects who develop stroke within 30 days after procedure.|peri-procedural (0 to 30 days after procedure)||||Participants|||Count of Participants
1304380|NCT03034954|Primary|Performance (d') on a Working Memory (Semantic 2-back) Test|The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.|30 minutes post-stimulation|missing data for eleven participants (5 Active; 6 Sham) due to Eprime miscalculation|||d'||Standard Deviation|Mean
1304381|NCT03034954|Primary|Performance (d') on a Working Memory (2-back) Test|The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.|30 minutes post-stimulation|missing data for two participants|||d'||Standard Deviation|Mean
1304382|NCT03034954|Primary|Performance (d') on a Simple Attention (0-back) Test|The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.|30 minutes post-stimulation|missing data for two participants|||d'||Standard Deviation|Mean
1304383|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Recognition Average Time to Respond|The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.|15 minutes after encoding|Missing data for one participant|||milliseconds||Standard Deviation|Mean
1304384|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Recognition Total Correct|The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.|15 minutes after encoding|Missing data for one participant|||number of correct answers||Standard Deviation|Mean
1304385|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond|"The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the room or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses."|15 minutes after encoding|Missing data for one participant|||milliseconds||Standard Deviation|Mean
1304386|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Cued Recall Average Error|"The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the room or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance."|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
1304387|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Cued Recall Total Error|"The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the room or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance."|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
1304388|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond|The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.|15 minutes after encoding|Missing data for one participant|||milliseconds||Standard Deviation|Mean
1304389|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Free Recall Average Error|The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
1304390|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Free Recall Total Error|The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
1304396|NCT03032965|Secondary|Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups|Prevalence of recovery of conduction into pulmonary veins during repeat ablation procedures in both groups. This is determined by surgeon assessment using a circular mapping catheter to identify recovery of conduction into the pulmonary veins.|post-procedure (6 months)|Only 21 participants had repeat ablations; each participant has four pulmonary veins therefore the number of connections measured is based 4 x the number of participants|||pulmonary veins|pulmonary veins||Count of Units
1304397|NCT03032965|Secondary|Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation||first three months post ablation|This data was not collected.||||||
1304398|NCT03032965|Secondary|Number of Subjects Who Need Repeat Ablations|Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.|date of ablation to 6 months after procedure||||Participants|||Count of Participants
1304399|NCT03032965|Primary|Freedom From Any Atrial Arrhythmias|Primary endpoint of the study will be number of participants who are free from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy|2- 14 months after Ablation procedure||||Participants|||Count of Participants
1304400|NCT03032263|Secondary|Incidence of Failed Nasal Intubation|The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.|1 day||||number of intubations|||Number
1304401|NCT03032263|Secondary|Presence of Nasal Bleeding|Number of participants that experienced nasal bleeding was recorded.|1 day||||Participants|||Count of Participants
1304402|NCT03032263|Secondary|Grade of Larynx View|Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible).|1 day||||units on a scale||Standard Deviation|Mean
1304403|NCT03032263|Secondary|Time to Intubation|Reported as the average time it took to intubate (seconds).|1 day||||seconds||Standard Deviation|Mean
1304404|NCT03032263|Primary|Number of Participants Requiring Use of Magill Forceps for Nasal Intubations|Reported as the number and percentage of participants that needed the use of Magill forceps during intubation|1 day||||Participants|||Count of Participants
1304405|NCT03031496|Secondary|Body Temperature Values at Indicated Time Points|Vital sign measurements including body temperature were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Degree Celsius||Standard Deviation|Mean
1304406|NCT03031496|Secondary|Pulse Rate Values at Indicated Time Points|Vital sign measurements including pulse rate were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
1304407|NCT03031496|Secondary|Respiratory Rate Values at Indicated Time Points|Vital sign measurements including respiratory rate were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Breaths per minute||Standard Deviation|Mean
1304408|NCT03031496|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Indicated Time Points|Vital sign measurements including SBP and DBP were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1304409|NCT03031496|Secondary|Total Protein Levels at Indicated Time Points|Serum total protein levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Grams per liter (g/L)||Standard Deviation|Mean
1304410|NCT03031496|Secondary|Creatinine, Direct Bilirubin and Total Bilirubin Levels at Indicated Time Points|Serum creatinine, direct bilirubin and total bilirubin levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1304411|NCT03031496|Secondary|Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium Levels at Indicated Time Points|Serum calcium, chloride, glucose, magnesium, potassium and sodium levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Millimoles per liter (Mmol/L)||Standard Deviation|Mean
1304412|NCT03031496|Secondary|Blood Urea Nitrogen (BUN) Levels at Indicated Time Points|Serum BUN levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1304413|NCT03031496|Secondary|Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.) and Aspartate Aminotransferase (AST) Levels at Indicated Time Points|Serum ALT, alk. phosph. and AST levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Unit per liter (U/L)||Standard Deviation|Mean
1304426|NCT03029650|Secondary|Assessment of Scopolamine Clearance (CL)|This will be done only after the IV is administered to estimate the rate of removal of scopolamine from the body. Will not be measured during patch arm.|Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr||||L/hr||Standard Deviation|Mean
1304414|NCT03031496|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment Period|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Only those participants with data available at the specified time points were analyzed|Up to 25 days|Safety Population comprised of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Number
1304415|NCT03031496|Secondary|Terminal Phase Half-life (T1/2) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||Hour||Full Range|Median
1304416|NCT03031496|Secondary|Percentage of AUC(0-inf) Obtained by Extrapolation (Percent AUCex) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent CIs for estimates of the geometric mean ratios between percent AUCex of the test and reference products in relation to the conventional bioequivalence range. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||Percent of area||Geometric Coefficient of Variation|Geometric Mean
1304417|NCT03031496|Secondary|Time of Occurrence of Cmax (Tmax) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Median and full range has been presented.|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||Hour||Full Range|Median
1304418|NCT03031496|Secondary|AUC From Time Zero to Infinity (AUC[0-inf]) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent CIs for estimates of the geometric mean ratios between the AUC (0-inf) of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1304419|NCT03031496|Primary|Maximum Observed Concentration (Cmax) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for pharmacokinetic (PK) analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent CIs for estimates of the geometric mean ratios between the Cmax of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects.|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1304420|NCT03031496|Primary|Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Hydrochlorothiazide and Amiloride Hydrochloride|Blood samples were collected at indicated time points under fasting conditions for pharmacokinetic (PK) analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent confidence intervals (CIs) for estimates of the geometric mean ratios between the AUC (0-t) of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects.|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population comprised of All participants who completed the study and for whom primary PK parameters was calculated for all treatment periods.|||Hour x nanograms/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1304421|NCT03029650|Secondary|Residual Drug Analysis in Worn TDDS|This will be done in the TDDS after its removal to estimate total amount of absorbed scopolamine.|3 - 6 months||||% residual drug recovery||Standard Deviation|Mean
1304422|NCT03029650|Secondary|Determination of Area Under the Serum Concentration-time Curve (AUC)||Measured at time points:1,2,3,4,5,6,8,10,12,24,36,48,60,72,73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours during Intervention: scopolamine HBr||||ng*hr/ml||Standard Deviation|Mean
1304423|NCT03029650|Secondary|Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)||Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr||||hr||Standard Deviation|Mean
1304424|NCT03029650|Secondary|Measurement of Elimination Rate Constant of Scopolamine (Kel)||Measured at time points: 73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr||||1/hr||Standard Deviation|Mean
1304425|NCT03029650|Secondary|Measurement of Volume of Scopolamine Distribution (V)|This measure is only analyzed for the IV scopolamine HBr arm of the study.|Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr||||L||Standard Deviation|Mean
1304427|NCT03029650|Primary|Measurement of Maximum Serum Concentration of Scopolamine (Cmax)||Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr|The number of participants analyzed represents the total number of participants that completed both interventions.|||ng/ml||Standard Deviation|Mean
1304428|NCT03028987|Secondary|Number of Participants With Related Adverse Events|Number of individual twins who experienced related adverse events through the course of the study.|Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304429|NCT03028987|Primary|Number of Participants Who Received Influenza Vaccine|Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment|Day 0||||Participants|||Count of Participants
1304430|NCT03028025|Secondary|Percent of Patients With Radial Artery Occlusion(RAO)|Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.|within 30 min of discharge or after 24 hours||||Participants|||Count of Participants
1304431|NCT03028025|Primary|Time to Hemostasis Using the Hemostasis Management System (HMS)|Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.|within 30 min of discharge or after 24 hours||||minutes||Standard Deviation|Mean
1304432|NCT03026803|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years||||percentage of participants|||Number
1304433|NCT03026257|Primary|Ex Vivo Total Cholesterol Uptake at Day 30|The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.|Day 30|Full Analysis Set with cholesterol uptake measured|||μg||Standard Deviation|Mean
1304434|NCT03024112|Secondary|ICU Length of Stay||30 days||||Days||Standard Deviation|Mean
1304435|NCT03024112|Secondary|Lowest Oxygen Saturation Level Measured|Lowest oxygen saturation level measured during hospitalization from admission to discharge|30 days||||percentage of oxygen saturation||Standard Deviation|Mean
1304436|NCT03024112|Secondary|Hospital Length of Stay|length of stay from hospital admission to hospital discharge|30 days||||Days||Standard Deviation|Mean
1304437|NCT03024112|Primary|Number of Participants With Post-operative Pulmonary Complications|"The primary outcome post-operative pulmonary complication is defined as present if any one of the following criteria are met:~SpO2 < 90% with FiO2 ≥ 50%~Dyspnea at rest~Respiratory rate > 25 breaths/min~Active use of accessory respiratory muscles~PaO2/FiO2 ratio < 200~Escalation of therapy to non-invasive ventilation~Re-intubation~Occurrence of hospital-acquired pneumonia~Re-admission to the ICU"|30 days||||Participants|||Count of Participants
1304438|NCT03023709|Primary|Number of Participants With Related Adverse Events||Day 0 to 14 post-immunization||||Participants|||Count of Participants
1304439|NCT03023709|Primary|Number of Participants Who Received Influenza Vaccine||Day 0|Study halted after Pilot Phase|||Participants|||Count of Participants
1304440|NCT03023683|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304441|NCT03023683|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
1304442|NCT03023553|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304443|NCT03023553|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
1304444|NCT03023488|Secondary|Post-Operative Characteristics - Complications|"The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).~Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications~Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside~Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included~Complications requiring surgical, endoscopic or radiological intervention~Life-threatening complications (including CNS complications) requiring IC/ICU management~Death"|The data will be recorded within 1 month after each procedure.||||Participants|||Count of Participants
1304445|NCT03023488|Secondary|Operative Characteristics - Intraoperative Complications|The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.|1 hour after the operation||||participants|||Number
1304446|NCT03023488|Secondary|Operative Characteristics - Irrigation Pressure|The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.|1 hour after the operation||||cmH2O||Full Range|Median
1304447|NCT03023488|Secondary|Duration of the Flexible Ureteroscopy Operation|the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.|10 minutes after the operation||||min||Standard Deviation|Mean
1304448|NCT03023488|Secondary|Technical Details - Name of Flexible Ureteroscope|Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra|1 hour after the operation||||participants|||Number
1304449|NCT03023488|Secondary|Technical Details - Size of Ureteral Access Sheath|The size of access sheaths will be given in French measurement. E.g. 10/12 Fr|1 hour after the operation||||participants|||Number
1304465|NCT03023137|Secondary|Gestational Diabetes Mellitus||Pregnancies reaching 24 weeks' gestation|A total of 154 pregnancies in group W&D and 98 pregnancies in the control group reached 24 weeks of gestation.|||mothers|||Number
1304450|NCT03023488|Primary|Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity [(PSV – EDV) / ((PSV + EDV) / 2)].~Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||unitless||Full Range|Median
1304451|NCT03023488|Primary|Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~Resistive index is calculated as the difference between PSV and EDV, divided by PSV [(PSV – EDV) / (PSV)].~An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||unitless||Full Range|Median
1304452|NCT03023488|Primary|End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||cm/s||Full Range|Median
1304453|NCT03023488|Primary|Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||cm/s||Full Range|Median
1304454|NCT03023176|Secondary|Number of Participants With Related Adverse Events||Day 0 to 32 post-immunization||||Participants|||Count of Participants
1304455|NCT03023176|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 32||||Participants|||Count of Participants
1304456|NCT03023137|Secondary|Neonates With Hypoglycemia|Hypoglycemia was defined as any blood glucose concentration ≤ 40 mg/dL.|One, two and fours hours after birth|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
1304457|NCT03023137|Secondary|Appropriate-for-gestational Age Babies||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
1304458|NCT03023137|Secondary|Babies Born at Term||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
1304459|NCT03023137|Secondary|Live-born Children||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
1304460|NCT03023137|Secondary|Second and Third-trimester Losses||28 weeks of gestation and end of gestation|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.|||fetuses|||Number
1304461|NCT03023137|Secondary|First-trimester Losses||14 weeks of gestation|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.|||embryos|||Number
1304462|NCT03023137|Secondary|Excessive Weight Gain|Weight gain >13 kg for underweight, normal weight or overweight mothers and > 9 kg for obese mothers|End of term pregnancies|A total of 148 pregnancies in group W&D and 57 pregnancies in the control group reached term.|||mothers|||Number
1304463|NCT03023137|Secondary|Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency||End of pregnancy||||mothers|||Number
1304464|NCT03023137|Secondary|Preeclampsia||Pregnancies reaching 20 weeks' gestation|A total of 154 pregnancies reached 20 weeks in group W&D and 98 in the control group.|||mothers|||Number
1337590|NCT01972659|Primary|TOF 0.9 Achieving Time||end of the surgery||||minutes||Standard Deviation|Mean
1304466|NCT03023137|Primary|Take-home Baby Rate||End of pregnancy|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.|||babies|||Number
1304467|NCT03022435|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304468|NCT03022435|Primary|Number of Participants Who Received Influenza Vaccine||Day 0||||Participants|||Count of Participants
1304469|NCT03022422|Secondary|Number of Individual Twins With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304470|NCT03022422|Primary|Number of Individual Twins Who Received Influenza Vaccine||Day 0||||Participants|||Count of Participants
1304471|NCT03022396|Secondary|Number of Individual Twins With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304472|NCT03022396|Primary|Number of Individual Twins Who Received Influenza Vaccine|All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.|Day 0 to 28|All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.|||Participants|||Count of Participants
1304473|NCT03021343|Primary|The Number of Participants With Colchicine Side Effects|The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.|From date of randomization until the date of discharge, assessed up to 2 weeks||||participants|||Number
1304474|NCT03021343|Primary|The Number of Participants With Atrial Fibrillation|The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant|From date of randomization until the date of discharge, assessed up to 2 weeks||||Participants|||Count of Participants
1304475|NCT03021304|Secondary|Percentage of Participants With Successful Self-administration of Their Unobserved Second Dose Outside the Clinic Setting at Week 4|The participant (or caregiver), self-administered the dose of study treatment outside the clinic and without observation during Week 4, up to 24 hours after attending clinic Visit 3. The ‘self-administration’ was defined as either administration of mepolizumab liquid drug product in safety syringe by the participants themselves or by their caregiver. The participant/caregiver completed an ‘At home Checklist’ outlining the various steps in the IFU to use the safety syringe. On returning to clinic the investigator inspected whether the returned safety syringe showed any signs that the full dose had not been administered.|Week 4|All Subjects (Safety) Population|||Percentage of participants|||Number
1304476|NCT03021304|Primary|Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8|During the clinic visits the Investigator or designee evaluated if the participants were able to self-administer the third dose at Week 8 by visual inspection immediately following injection and by using an ‘Observer checklist’ based on the safety syringe Instructions for Use (IFU). The ‘self-administration’ was defined as administration of mepolizumab liquid drug product in safety syringe either by the participants themselves or by their caregiver. Failure to perform one of the critical steps was deemed to be failure to successfully administer the injection. Participants with data available at Week 8 have been analyzed. Analysis was performed on All Subjects (Safety) Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.|Week 8|All Subjects (Safety) Population|||Percentage of participants|||Number
1304477|NCT03020576|Secondary|Change in Motor Activity Log How Well|quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.|Through study completion (taken at baseline and on 8 week study completion)||||units on a scale||Standard Deviation|Mean
1304478|NCT03020576|Secondary|Change in Spasticity Measures|The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.|Through study completion, an average of 8 weeks||||change in units on a scale||Standard Deviation|Mean
1304479|NCT03020576|Secondary|Change in Hand Dexterity|The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.|Through study completion, an average of 8 weeks||||units on a scale||Standard Deviation|Mean
1304480|NCT03020576|Secondary|Change in Mobility and Activities of Daily Living|The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.|Through study completion (taken at baseline and at 8 week study completion)||||units on a scale||Standard Deviation|Mean
1304481|NCT03020576|Secondary|Change in Motor Activity Log Amount|quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.|Through study completion (taken at baseline and at 8-week study completion)||||units on a scale||Standard Deviation|Mean
1304482|NCT03020576|Secondary|Change in Hand and Pinch Strength|quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms|Through study completion, an average of 8 weeks||||change in kilograms||Standard Deviation|Mean
1304483|NCT03020576|Secondary|Change in Range of Motion Measures|quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)|Through study completion, an average of 8 weeks||||change in units on a scale||Standard Deviation|Mean
1304484|NCT03020576|Primary|Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer|quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.|Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)||||change in units on a scale||Standard Deviation|Mean
1304485|NCT03020537|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304487|NCT03020498|Other Pre-specified|Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.||Day 0 to 28|||||||
1304488|NCT03020498|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1304489|NCT03020498|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
1304490|NCT03020472|Other Pre-specified|PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT.||Day 0 to Day 28|||||||
1304491|NCT03020472|Other Pre-specified|Post- Immunization B- Cell Response|Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)|5-13 days post immunization|Due to the low enrollment, the study was terminated and analysis was not performed.||||||
1304492|NCT03020472|Secondary|Number of Participants With Related Adverse Events||Day 0 to Day 28||||Participants|||Count of Participants
1304493|NCT03020472|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to Day 28||||Participants|||Count of Participants
1304494|NCT03020004|Primary|Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment|SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration|24 weeks||||Participants|||Count of Participants
1304495|NCT03019783|Secondary|Change in Plasma Total Antioxidant Capacity|The investigators will evaluate plasma total antioxidant capacity at study entry and then after 28 days, with the change between the two measurements being the secondary endpoint.|4 weeks||||micromolar||Standard Deviation|Mean
1304496|NCT03019783|Primary|Change in Flow-mediated, Endothelium-dependent Vasodilation|The investigators will evaluate flow-mediated, brachial artery vasodilation (percentage increase in diameter in response to a 5 minute ischemic challenge) at study entry and then after 28 days, with the change between the two measurements being the primary endpoint.|4 weeks||||percentage vasodilation||Standard Deviation|Mean
1304497|NCT03018106|Primary|Vaginal Irritation|Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
1304498|NCT03018106|Primary|Vaginal Itching|Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
1304499|NCT03018106|Primary|Vaginal Dryness|Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
1304500|NCT03018106|Primary|Pain With Sex|Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
1304501|NCT03018106|Primary|Female Sexual Function Index Score|The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
1304502|NCT03017612|Secondary|Uncorrected Intermediate Visual Acuity|75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better|at 12 months postoperatively||||Percentage of Implanted Eyes|||Number
1304503|NCT03017612|Secondary|Occurrence of Adverse Events|Any specific adverse event should occur in less than or equal to 5% of eyes.|During the length of the study, up to 24 months||||Occurrence of specific adverse events|||Number
1304504|NCT03017612|Secondary|Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D|Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D|At 6 months postoperatively and all subsequent time points up to 24 months||||Percentage of Implanted Eyes|||Number
1304505|NCT03017612|Secondary|Preservation of Best Corrected Visual Acuity|Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40|at 6 months postoperatively and all subsequent time points up to 24 months||||Percentage of Implanted Eyes|||Number
1304506|NCT03017612|Primary|Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision|75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better|12 months postoperatively||||Percentage of Implanted Eyes|||Number
1304507|NCT03016078|Secondary|Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)|"Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change).~Nurse/ Investigator evaluate with No/Yes"|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
1304544|NCT03010800|Primary|Pad Weight Difference|Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.|An hour after finishing a liter of liquid||||grams|||Number
1304508|NCT03016078|Secondary|Evaluation of the Dressing Capacity of Handling Blood|Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
1304509|NCT03016078|Secondary|Number of Dressing Changes Per Subject|To evaluate the number of dressing changes per subject|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Number of dressing changes per subject||Standard Deviation|Mean
1304510|NCT03016078|Secondary|Participants' Dressing Wear Time (Days)|The number of days the dressing can stay on are evaluated|7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||days||Standard Deviation|Mean
1304511|NCT03016078|Secondary|Number of Participants With Bleeding Caused by Dressing Removal|Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits..|||Participants|||Count of Participants
1304512|NCT03016078|Secondary|Number of Participants With Dressing Sticking to the Staples/Sutures|Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
1304513|NCT03016078|Secondary|Number of Participants With Leakage of the Dressing|Nurse/ Investigator evaluate: Leakage (No/Yes)|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
1304514|NCT03016078|Primary|Number of Participants With Damage to the Incision and Surrounding Skin|"The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:~Blistering (Yes/No) by visit~Redness under dressing (Yes/No) by visit~Redness outside dressing (Yes/No) by visit~Maceration under dressing (Yes/No) by visit~Maceration outside dressing (Yes/No) by visit"|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
1304515|NCT03014674|Secondary|Number of Participants With Positive Neutralizing Antibodies|Blood samples were collected for the determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result. Number of participants with positive neutralizing antibodies at any time post-Baseline are presented here. Only those participants available at the specified time points were analyzed.|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
1304516|NCT03014674|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies|Blood samples were collected for the determination of anti-mepolizumab antibodies. A binding anti-drug antibody (ADA) assay was performed. There were three tiered analysis: screening, confirmation and titration. The results of binding ADA were categorized as negative, transient positive (defined as a single confirmatory positive immunogenic response that does not occur at the final study assessment) or persistent positive (defined as a confirmatory positive immunogenic response for at least 2 consecutive assessments excluding the Screening visit, or a single result at the final study assessment). A participant was considered positive if they had at least one positive post-Baseline ADA result. Number of participants with positive anti-mepolizumab antibodies at any time post-Baseline are presented here. Only those participants available at the specified time points were analyzed.|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
1304517|NCT03014674|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings|Single measurements of 12-lead ECGs were obtained after 5 minutes of rest in a supine position for the participant. ECG was performed on Day 1 and Day 85 using an automated ECG machine. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Participants with abnormal ECG findings that are clinically not significant and clinically significant data has been presented here. The data of worst case post-Baseline is presented here. Only those participants available at the specified time points were analyzed.|Baseline and Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
1304518|NCT03014674|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||breaths per minute||Standard Deviation|Mean
1304519|NCT03014674|Secondary|Change From Baseline in Temperature|Temperature was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||degree Celsius||Standard Deviation|Mean
1304570|NCT02988882|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching|3 minutes||||units on a scale||Standard Deviation|Mean
1304520|NCT03014674|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||Beats per minute||Standard Deviation|Mean
1304521|NCT03014674|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|SBP and DBP were measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1304522|NCT03014674|Secondary|Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range|"Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of creatinine, creatine kinase, glucose, protein, potassium, urea, sodium, calcium, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct bilirubin (D.bili) and bilirubin, and albumin. Participants were counted in the worst case category that their value changes to Low, Normal or High. Participants whose value category was unchanged or whose value became normal, were recorded in the To Normal or No Change category. The worst case post-Baseline values has been reported. Only those participants with data available at the specified data points were analyzed. For the category “to low ” NA indicates data was not available as the lower limit of normal is zero for this parameter."|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
1304523|NCT03014674|Secondary|Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range|"Hematology parameters included assessment of platelet count, erythrocytes, leukocytes, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Participants were counted in the worst case category that their value changes to Low, Normal or High. Participants whose value category was unchanged or whose value became normal, were recorded in the To Normal or No Change category. The worst case post-Baseline values has been reported. For basophils the “to low” category is not applicable (NA) as the lower limit of normal is zero for this parameter."|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
1304524|NCT03014674|Secondary|Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions|Adverse events of special interest like local injection site reactions and systemic reactions like allergic Type I hypersensitivity were reported along with AEs and SAEs. Participants with local injection site reaction and Allergic Type I hypersensitivity systemic reactions are reported here.|Up to 28 days post-dose|All Treated Subjects (Safety) Population|||Participants|||Number
1304525|NCT03014674|Secondary|Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All Treated Subjects (Safety) comprised of all participants who received mepolizumab. Participants with non-serious AEs (3 percentage threshold) and SAEs has been reported.|Up to 28 days post-dose|All Treated Subjects (Safety) Population|||Participants|||Number
1304526|NCT03014674|Secondary|Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab|Blood samples were collected at indicated time points. Percentage AUCex following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1304527|NCT03014674|Secondary|Terminal Phase Half-life (t½) of Mepolizumab|Blood samples were collected at indicated time points for calculating t½. t½ following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Days||Geometric Coefficient of Variation|Geometric Mean
1304528|NCT03014674|Secondary|Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab|Blood samples were collected at indicated time points. Lambda z following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Per hours||Geometric Coefficient of Variation|Geometric Mean
1304529|NCT03014674|Secondary|Apparent Volume of Distribution (Vd/F) of Mepolizumab|Blood samples were collected at indicated time points. Vd/F following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1304530|NCT03014674|Secondary|Apparent Clearance (CL/F) of Mepolizumab|Blood samples were collected at indicated time points . CL/F following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1304619|NCT02984267|Secondary|Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt||Assessed immediately during epidural catheter placement||||Participants|||Count of Participants
1304531|NCT03014674|Secondary|Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab|Blood samples were collected at indicated time points. Tmax and tlast following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Days||Full Range|Median
1304532|NCT03014674|Primary|Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]), AUC From Time Zero Extrapolated to Infinite Time (AUC[0-inf]) of Mepolizumab|Blood samples were collected at indicated time points. AUC(0-t) and AUC(0-inf) following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Fixed effects analysis of covariance model was used for analysis. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Days*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1304533|NCT03014674|Primary|Maximum Observed Plasma Concentration (Cmax) of Mepolizumab|Blood samples were collected at indicated time points. Cmax following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with reconstituted lyophilized drug product from the vial. Pharmacokinetic (PK) Population comprised of all participants receiving study drug for whom a pharmacokinetic sample was obtained and analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1304534|NCT03011099|Secondary|Exoskeleton User Feedback as Assessed by a Questionnaire|A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.|week 4|This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training.|||units on a scale||Standard Deviation|Mean
1304535|NCT03011099|Secondary|Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)|"The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:~0 = total paralysis~= palpable or visible contraction~= active movement, full range of motion (ROM) with gravity eliminated~= active movement, full ROM against gravity~= active movement, full ROM against gravity and moderate resistance in a muscle specific position~= (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person~We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment."|baseline, week 4||||units on a scale||Standard Deviation|Mean
1304536|NCT03011099|Secondary|Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)|Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).|baseline, week 4||||seconds||Standard Deviation|Mean
1304537|NCT03011099|Secondary|Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)|Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.|baseline, week 4||||cm||Standard Deviation|Mean
1304538|NCT03011099|Secondary|Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)|Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.|baseline, week 4||||steps/min||Standard Deviation|Mean
1304539|NCT03011099|Primary|Change in Energy Expenditure During Walking as Assessed by Oxygen Cost|Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).|baseline, week 4|The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational.|||ml/min/kg||Standard Deviation|Mean
1304540|NCT03011099|Primary|Change in Muscle Activity as Assessed by Surface Electromyography (EMG)|Surface EMG sensors will be placed on the skin of subjects’ lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.|baseline, week 4|This measure was later added to the protocol and hence data was collected from one participant only.|||percentage of muscle activity change|||Number
1304541|NCT03011099|Primary|Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test|The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.|baseline, week 4||||Second||Standard Deviation|Mean
1304542|NCT03011099|Primary|Change in Walking Endurance as Assessed by the 6 Minute Walk Test|The 6 Minute Walk Test assesses the distance walked in 6 minutes.|baseline, week 4||||feet||Standard Deviation|Mean
1304543|NCT03011099|Primary|Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test|The 10 Meter Walk Test assesses the time taken to walk 10 meters.|baseline, week 4||||seconds||Standard Deviation|Mean
1309914|NCT02588976|Primary|Kaolin-activated Clotting Time||Routine measurements during cardiac surgery||||seconds||Standard Deviation|Mean
1304545|NCT03005067|Secondary|Average Total Symptom Score Over Days 1-7 (ATSS1-7)|The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.|Up to Day 7 (Day 1 to 7)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1304546|NCT03005067|Secondary|Average Total Symptom Score Over Days 1-4 (ATSS1-4)|The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.|Up to Day 4 (Day 1 to 4)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1304547|NCT03005067|Secondary|Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)|The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.|Up to Day 7 (Day 1 to 7)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1304548|NCT03005067|Primary|Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)|The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.|Up to Day 4 (Day 1 to 4)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1304549|NCT03005041|Secondary|Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)|Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.|Within 5 minutes post product use|Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.|||Participants|||Count of Participants
1304550|NCT03005041|Secondary|Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)|Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No)|Within 30 ± 5 minutes post product use|Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.|||Participants|||Count of Participants
1304551|NCT03005041|Secondary|Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7|Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected “None” for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use.|Within 2 minutes post product use|ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. Note: Number of participants who answered question 6 proceeded to answer question 7. Participants also chosen more than one answer for question 7.|||Participants|||Count of Participants
1304552|NCT03005041|Primary|Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1|Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? “This product is gentle”: disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome..|Within 2 minutes post product use|Analysis for this outcome was performed on intent to treat (ITT) population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.|||Participants|||Count of Participants
1304553|NCT03002454|Primary|Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.|All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.|60 days|Each participant (4) acted as their own control to reduce variance. Paired image sets were analyzed visually for concordant biodistribution between the 99mTc Medronate Injection prepared with 99mTc derived from Neutron-activation produced 99Mo versus 99mTc Medronate Injection derived from Fission-produced 99Mo referenced as the baseline standard.|||Participants|||Count of Participants
1304554|NCT03001674|Primary|Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.|We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.|24 hours||||mmHg-mL||Standard Deviation|Mean
1304555|NCT03001453|Primary|Number of Patients That Experienced a Fall||72 hours postoperation||||participants|||Number
1304556|NCT03001453|Primary|Length of Stay (LOS, in Days)||From time of surgery until patient is discharged, an average of 1.5 days.||||Hours||Standard Deviation|Mean
1304557|NCT03001453|Primary|Time to Ambulation More Than 20 Feet (in Hours)|The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.|from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first||||hours||Standard Deviation|Mean
1304558|NCT03001453|Primary|Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score|Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort’s reported average pain scores at each 12-hour interval.|72 hours post-operation, divided into six 12-hour periods||||units on a scale||Standard Deviation|Mean
1304559|NCT03001453|Primary|Patient Morphine Equivalent Consumption|All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.|72 hours postoperation, divided into six 12-hour periods||||mg||Standard Deviation|Mean
1304560|NCT03001258|Primary|Screening Accuracy|The outcome was considered as accurate and coded as “1” if the screening result agreed with the gold standard. That is, if the screening result is positive for presbyopia and the refractionist also reported it as positive or the screening result is negative and the refractionist also reported as negative.|The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period||||percentage of cases||95% Confidence Interval|Number
1304561|NCT03000088|Primary|Time to Intubation||10 minutes around intubation||||seconds||Standard Deviation|Mean
1304562|NCT02997904|Secondary|Total Number of Lice Removed, Total Number of Eggs Removed|Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately|1 hour|Intent To Treat; including all subjects enrolled|||Number of Lice or Number of Eggs||Standard Deviation|Mean
1304563|NCT02997904|Primary|The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing|A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.|1 hour|Intent To Treat; including all subjects who were enrolled in the study.|||number of lice and eggs removed||Standard Deviation|Mean
1304564|NCT02991820|Secondary|Successful Intubation Within 120 Seconds|The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.|2 minutes||||Participants|||Count of Participants
1304565|NCT02991820|Primary|Time to Endotracheal Intubation|The amount of time it took to successfully intubate the manikin using each device.|the same day (within seconds to minutes)||||seconds||Standard Deviation|Mean
1304566|NCT02990910|Secondary|Median Survival Time of CHEOPS> 6 in the Two Groups.|Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups)of CHEOPS＞6 in two groups.|Time from entering the PACU until the patient leaves,approx 1 hour.||||minute||95% Confidence Interval|Median
1304567|NCT02990910|Primary|Number of Participants With Respiratory Adverse Events in PACU(Postanesthesia Care Unit).|The main observation indexes was the incidence of respiratory adverse events in PACU, the ratio was the number of children who occurred respiratory adverse events to the total number of children. Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.|Time from entering the PACU until the patient leaves,approx 1 hour.||||Participants|||Count of Participants
1304568|NCT02988882|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching|7 minutes||||units on a scale||Standard Deviation|Mean
1304569|NCT02988882|Primary|Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching|5 minutes||||units on a scale||Standard Deviation|Mean
1342340|NCT01916681|Secondary|Mode of Delivery|Cesarean Delivery|Start of induction to delivery||||participants|||Number
1304571|NCT02988622|Primary|Observer Total Score|Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).|Baseline and 6 months.|Patients with available data.|||units on a scale||Standard Deviation|Mean
1304572|NCT02988622|Primary|Patient Satisfaction|Patients rated how satisfied they were with the appearance of each half of the treated scar.|6 months|Participants with available data.|||Participants|||Count of Participants
1304573|NCT02988622|Primary|Overall Opinion|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
1304574|NCT02988622|Primary|Scar Irregularity|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
1304575|NCT02988622|Primary|Scar Thickness|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
1304576|NCT02988622|Primary|Scar Stiffness|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
1304577|NCT02988622|Primary|Scar Color|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
1304578|NCT02988622|Primary|Scar Itching|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
1304579|NCT02988622|Primary|Scar Pain|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
1304580|NCT02988219|Secondary|The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed|The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them|60 months|arrhythmias analysed: bradycardia, pause > 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)|||Participants|||Count of Participants
1304581|NCT02988219|Primary|Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period|"The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them~Arrhythmias observed:~tachycardia >100 bpm bradycardia < 50 bpm pause (P-P interval > 2 seconds) ventricular extrasystoles (VE) > 1000/ 24 hours supraventricular extrasystoles (SVE) >200/24 hours"|60 months||||Participants|||Count of Participants
1304582|NCT02987868|Primary|Percent Change of Triiodthyronine Over Baseline|Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3||||percent change||Standard Deviation|Mean
1304583|NCT02987374|Other Pre-specified|Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.|Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.|Day -5 to 180 post-immunization|||||||
1304584|NCT02987374|Secondary|Number of Participants With Related Adverse Events||Day 0 to 180 post-immunization|Number of participants with related adverse events up to 180 days post immunization|||Participants|||Count of Participants
1304585|NCT02987374|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 180 post-immunization|10 participants received the 2011-2012 Fluzone IIV3 vaccine|||Participants|||Count of Participants
1304586|NCT02987205|Other Pre-specified|Other Efficacy Variables Include Change in Investigator Global Aesthetic Improvement (iGAI) Score|Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)|Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12|||||||
1304587|NCT02987205|Other Pre-specified|Other Efficacy Variables Include Change in Patient Global Aesthetic Improvement (pGAI) Score|Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)|Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12|||||||
1304588|NCT02987205|Other Pre-specified|Other Efficacy Variables Include Change in WSRS Score|Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)|Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12|||||||
1304589|NCT02987205|Secondary|Secondary Efficacy Endpoints Are the Responder Rate, Percentage of *Nasolabial Folds* With Treatment Success|"Treatment success (defined as at least a 1-grade improvement in WSRS from baseline to Week 24):~The WSRS Score is a 5-point scale. The WSRS score was assessed for each NLF at every study visit through Visit 6/Week 24 by a blinded evaluator (blinded to the treatment assignment of each NLF)."|Visit 6/Week 24|Per-Protocol (PP) Population|||Nasolabial Folds|Nasolabial Folds||Count of Units
1304620|NCT02984267|Secondary|Number of Attempts at Epidural Catheter Placement||Assessed immediately during epidural catheter placement||||Number of attempts||Inter-Quartile Range|Median
1304590|NCT02987205|Primary|Primary Efficacy Variable is Change From Baseline to Visit 6/Week 24 in Wrinkle Severity Rating Scale (WSRS) Score|"Primary efficacy variable is change from Baseline to Visit 6/Week 24 in Wrinkle Severity Rating Scale (WSRS) - Treatment success is defined as at least a 1-grade improvement in WSRS from baseline to Week 24~WSRS Score categories:~Absent - No visible fold; continuous skin line.~Mild - Shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance.~Moderate - Moderately deep folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant.~Severe - Very long and deep folds; prominent facial feature; less than 2 mm visible when stretched; significant improvement is expected from injectable implant.~Extreme - Extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone."|Visit 6/Week 24|Analysis of effectiveness based on Per Protocol analysis which includes 125 evaluable patients at 24 weeks.|||scores on a scale|Nasolabial Folds|95% Confidence Interval|Mean
1304591|NCT02986854|Secondary|Within Group hSBA Geometric Mean Ratios (GMRs)|Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.|At Day 4, Day 6, Day 29 compared to Day 1|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Ratios||95% Confidence Interval|Geometric Mean
1304592|NCT02986854|Secondary|hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.|For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.|At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Titers||95% Confidence Interval|Geometric Mean
1304593|NCT02986854|Secondary|Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y|Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers <4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.|At Day 4 and Day 6|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentages of subjects||95% Confidence Interval|Number
1304594|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination) , day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304595|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304596|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|At day 1(pre-vaccination) , day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304597|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304598|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304621|NCT02984267|Secondary|Epidural Procedure Time|Time required to successfully place the epidural catheter|Assessed immediately during epidural catheter placement||||Minutes||Standard Deviation|Mean
1342341|NCT01916681|Primary|Severe RDS||enrollment through neonatal discharge||||participants|||Number
1304599|NCT02986854|Secondary|Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304600|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination) , day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304601|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentages of subjects||95% Confidence Interval|Number
1304602|NCT02986854|Secondary|Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)|"Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.~SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed."|From Day 1 through Day 181 (entire study period)|Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.|||Participants|||Count of Participants
1304603|NCT02986854|Secondary|Number of Subjects Reporting All Unsolicited AEs|An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.|From Day 1 through Day 29 after vaccination|Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.|||Participants|||Count of Participants
1304604|NCT02986854|Secondary|Number of Subjects Reporting Other Indicators of Reactogenicity|Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)|From Day 1 (6 hours) through Day 7 after vaccination|Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.|||Participants|||Count of Participants
1304605|NCT02986854|Secondary|Number of Subjects Reporting Solicited Local and Systemic AEs|Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (<25 mm), Any (>= 25 mm)|From Day 1 (6 hours) through Day 7 after vaccination|Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.|||Participants|||Count of Participants
1304606|NCT02986854|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.|Within 30 minutes after vaccination|Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.|||Participants|||Count of Participants
1304622|NCT02984267|Primary|Total Time Required for Epidural Catheter Placement|Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter|Assessed immediately during epidural catheter placement||||Minutes||Standard Deviation|Mean
1304623|NCT02983981|Secondary|Dermatology Life Quality Index|calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|16 weeks||||units on a scale||Standard Deviation|Mean
1304624|NCT02983981|Secondary|Psoriasis Severity|Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.|16 weeks||||percentage of BSA||Standard Deviation|Mean
1346744|NCT01844765|Secondary|Emerging Signs of Resistance|Mutational assessment of BCR-ABL|up to 66 cycles||2021-10-31|10/2021||||
1304607|NCT02986854|Primary|Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.|Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives|At Day 29|Analysis was performed on the per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis who received the study vaccination & provided evaluable serum samples at Day 29 with results available for atleast one serogroup|||Percentage of subjects||95% Confidence Interval|Number
1304608|NCT02986282|Secondary|Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.|3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants|Through the study period||||ratio||Inter-Quartile Range|Median
1304609|NCT02986282|Primary|Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).|3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.|Through the study||||ratio||Inter-Quartile Range|Median
1304610|NCT02984878|Secondary|Patient Global Aesthetic Improvement (pGAI) Score|Subjects were evaluated on the Patient Global Aesthetic Improvement (pGAI) Patient Global Aesthetic Improvement (pGAI) Score: 1 = Worse, 2 = No change, 3 = Improved, 4 = Much improved, 5 = Very much improved|Visit 8/Week 52|Subjects were evaluated on the Patient Global Aesthetic Improvement (pGAI)|||Participants|||Count of Participants
1304611|NCT02984878|Secondary|Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity|Assess safety concerns with retreatment of Revanesse Ultra for men or women at least 22 years of age with NLFs with a moderate or severe WSRS score at baseline who had previously received 1 or 2 treatments with Restylane or Revanesse Ultra, Adverse Events (AEs), which were defined, recorded, reported, and evaluated|Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52|Counts reflect numbers of subjects reporting one or more injection site TEAE that map to the MedDRA (version 15.1) system organ class/preferred term. At each level of summarization (system organ class or preferred term), subjects reporting more than one injection site TEAE are counted only once.|||Participants|||Count of Participants
1304612|NCT02984878|Primary|Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups - WSRS Scores at Visit 8/Week 52|Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups Achieving Similar WSRS Scores at Visit 8/Week 52 - WSRS Score categories: 1. Absent - No visible fold; continuous skin line. 2. Mild - Shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance. 3. Moderate - Moderately deep folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant. 4. Severe - Very long and deep folds; prominent facial feature; less than 2 mm visible when stretched; significant improvement is expected from injectable implant. 5. Extreme - Extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone. An increase in the WSRS score indicates a worsening of severity.|Visit 8/Week 52|Subjects that completed the SYM 2014-02 Main Study were eligible for the SYM 2014-02 Retreatment Study.|||units on WSRS scale|Nasolabial Folds|Standard Deviation|Mean
1304613|NCT02984267|Secondary|Overall Anesthesia Experience Satisfaction|Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.|Measured within 24 hours of delivery||||Units on a scale||Standard Deviation|Mean
1304614|NCT02984267|Secondary|Palpation or Ultrasound Time|The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion|Assessed immediately prior to epidural catheter placement||||Minutes||Standard Deviation|Mean
1304615|NCT02984267|Secondary|Patient Anxiety Level|Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.|Assessed immediately following epidural catheter placement||||Units on a scale||Standard Deviation|Mean
1304616|NCT02984267|Secondary|Epidural Catheter Placement Satisfaction Level|Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.|Assessed immediately following epidural catheter placement||||Units on a scale||Standard Deviation|Mean
1304617|NCT02984267|Secondary|Epidural Failure Rate|Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported|Assessed within 24 hours after delivery||||Participants|||Count of Participants
1304618|NCT02984267|Secondary|Complications|Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.|Assessed immediately during epidural catheter placement and within 24 hours after delivery||||Complications|||Number
1304625|NCT02983981|Secondary|Psoriasis Severity|Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis|16 weeks||||units on a scale||Standard Deviation|Mean
1304626|NCT02983981|Primary|Psoriasis Severity|Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.|16 weeks||||units on a scale||Standard Deviation|Mean
1304627|NCT02982018|Secondary|Percentage of Eyes With Subject Reported Symptoms Problems or Complaints|Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.|Up to 12-Week Follow-up|All subjects that were dispensed at least one study lens.|||Percentage of eyes|Eyes||Number
1304628|NCT02982018|Secondary|Contact Lens Wearing Time|Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.|Up to 12-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Hours||Standard Deviation|Mean
1304629|NCT02982018|Primary|Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings|Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.|Up to 12-Week Follow-up|All subjects that were dispensed at least one study lens.|||Percentage of eyes|Eyes||Number
1304630|NCT02982018|Primary|Distance Monocular logMAR Visual Acuity (VA)|Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.|Up to 12-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
1304631|NCT02982018|Primary|Eyestrain Related to Glare|Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.|Up to 12-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
1304632|NCT02978833|Secondary|Pain During Forward Step-down Test|"Pain will be assessed using the 10-cm Visual Analog Scale, which will range from no pain to worst possible pain."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
1304633|NCT02978833|Secondary|Pain During Side-lying Hip Abduction|"Pain will be assessed using the 10-cm Visual Analog Scale, which will range from no pain to worst possible pain."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
1304634|NCT02978833|Secondary|Quality of Movement During the Forward Step-down Test|"The quality of movement will be assessed on a scale of 0-4+, where 4+=good, 2-3=moderate, and 0-1=poor."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
1304635|NCT02978833|Primary|Patient Satisfaction|"The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from very dissatisfied to extremely satisfied."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
1304636|NCT02978833|Primary|Improvement in Function|The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
1304637|NCT02978833|Primary|Improvement in Pain|The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
1304638|NCT02977572|Secondary|Hospital Mortality|Mortality during hospital stay (including at Intensive care mortality)|Mortality (%) at Hospital at discharge from hospital||||Participants|||Count of Participants
1304639|NCT02977572|Secondary|28th Day Mortality|Mortility of patients within of the first 28 days after randomization (either at intensive car unit or at hospital)|Mortality within 28 days of randomization||||Participants|||Count of Participants
1304640|NCT02977572|Secondary|Intensive Care Unit Mortality|Mortality (%) at Intensive Care Unit|Mortality (%) at Intensive Care Unit at discharge from intensive care unit||||Participants|||Count of Participants
1304641|NCT02977572|Secondary|Length of Hospital Stay|All the time (days) the patient stays at the hospital|Length of stay (days) at hospital at discharge from hospital||||days||Inter-Quartile Range|Median
1304642|NCT02977572|Secondary|Length of Stay at Intensive Care Unit|Length of stay of the patient at Intensive Care Unit|Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.||||days||Inter-Quartile Range|Median
1304643|NCT02977572|Secondary|Acute Renal Failure|Development of acute renal failure measured as increase of level of creatinine|Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)||||Participants|||Count of Participants
1304644|NCT02977572|Secondary|Ventilator Acquired Pneumonia|Pulmonary infections (%) during stay at intensive care unit|Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation||||Participants|||Count of Participants
1304768|NCT02956460|Primary|Lens Handling|Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle|2 weeks||||units on a scale||Standard Deviation|Mean
1304645|NCT02977572|Secondary|Duration of the Ventilation|Period of ventilation (either noninvasive ventilation or continouos positive airway pressure) while the patient suffers from acute respiratory failure secondary to cardiopulmonary edema|Time (hours) from start of ventilation until the removal of both devices because of improve or failure||||hours||Inter-Quartile Range|Median
1304646|NCT02977572|Primary|Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit||Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit||||Participants|||Count of Participants
1304647|NCT02974543|Primary|Change in Tinnitus Loudness as Assessed by TinnTester|Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.|4 weeks on treatment (or sham)|First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).|||dB||Standard Deviation|Mean
1304648|NCT02974543|Primary|Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline|Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.|Four weeks on treatment (or sham)|First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).|||units on a scale||Standard Deviation|Mean
1304649|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)|Participants performed a walking assessment in comfortable walking shoes to measure gait parameter walking speed over 5-10m for each foot. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.|At Day 2 (pre and post-treatment) and Day 3|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||meters/second||Standard Deviation|Mean
1304650|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)|Participants performed a walking assessment in comfortable walking shoes to measure gait parameter stride length. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Centimeter||Standard Deviation|Mean
1304651|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)|Participants performed a walking assessment in comfortable walking shoes to measure gait parameter contact phase. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Seconds||Full Range|Median
1304652|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)|From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. GRF was measured during the movement analyzed using a force plate interfaced with a computer.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Newtons||Standard Deviation|Mean
1304670|NCT02971670|Primary|Persistence of TSST-1 Antibodies|ELISA IgG against rTSST-1. Persistence of antibody was defined as a >/= 4-fold increase in TSST-1 Ab titer as compared to pre-vaccination values.|6-15 months after last immunization of Phase I||||Participants|||Count of Participants
1304671|NCT02971670|Primary|Number of Participants With Adverse Events as a Measure of Safety|Clinical observation and clinical laboratory values|through 6 months|Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.|||participants|||Number
1304653|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)|Time to standing provides a simple assessment of physical mobility. From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Time to standing recorded which was measured using a stopwatch. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Seconds||Full Range|Median
1304654|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)|This task was a measure of grip strength. The participant held the dynamometer in their dominant hand and the arm was swung from above the head to by the side of the body. If the dominant arm or hand was painful then the non-dominant hand was used. The participant was instructed to assert maximum effort during the squeezing motion and maintain it for about 4 seconds using a metronome. Participant conducted the movement 4-times (1 practice effort and 3 test efforts) and there was a 1-minute recovery period between each effort.|At Day 2 (pre and post-treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Kilogram (Kg)||Standard Deviation|Mean
1304655|NCT02974114|Primary|Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)|RVP task was measures of attention. A white box appeared in the centre of the computer screen, inside which digits, from 2 to 9, appeared in a pseudo-random order, at the rate of 100 digits per minute. Participants were requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. The RVPA (A prime) was the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range will be 0.00 to 1.00; bad to good). RVP metric was a measure of how good the subject was at detecting target sequences.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||msec||Full Range|Median
1304656|NCT02974114|Primary|Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)|SWM task was a measure of working memory. The task involved number of coloured squares (boxes) being shown on the screen. The aim of this test was to find one blue token in the boxes shown to the participants by process of elimination and used these to fill up an empty column on the right-hand side of the screen. The number of boxes gradually increased up to a maximum of eight boxes to search and the colour and position of the boxes changed from trial to trial. SWM between errors was defined as times the participant revisited a box in which a token has previously been found. This was calculated for trials of four, six and eight tokens.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||SWM between errors||Standard Deviation|Mean
1304657|NCT02974114|Primary|Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)|AST was a measure of executive attention. The test displayed an arrow which can appear on either side of the screen and can point in either direction. Each trial displayed a cue at the top of the screen that indicates whether to press the right or left button. Some trials displayed congruent stimuli (e.g. arrow on the right side of the screen pointing to the right) whereas other trials display incongruent stimuli which require a higher cognitive demand (e.g. arrow on the right side of the screen pointing to the left). The AST congruency cost was the difference between the median latencies of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. It was calculated by subtracting the median of congruent from incongruent latency. A positive score indicated response was faster on congruent trials and a negative score indicated response was faster on incongruent trials.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||msec||Full Range|Median
1304658|NCT02974114|Primary|Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)|OTS was a measure of executive function and takes approximately 10 minutes to complete. The participant was shown two displays containing three coloured balls. The displays were presented in such a way that they can easily be perceived as stacks of coloured balls held in stockings or socks suspended from a beam. There was a row of numbered boxes along the bottom of the screen. The test administrator first demonstrated to the participant how to use the balls in the lower display to copy the pattern in the upper display, and completed one demonstration problem, where the solution requires one move. The participant then completed three further problems, one each of two moves, three moves, and four moves. Next, the participant was shown further problems, and participants worked out in their head how many moves the solutions to these problems required, and then touch the appropriate box at the bottom of the screen to indicate their response.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||OTS of correct first box choice||Standard Deviation|Mean
1304672|NCT02969863|Primary|Percentage of Time Spent With Dexcom CGMG < 60 mg/dl|A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl|days 2-7||||percentage of time||Standard Deviation|Mean
1304769|NCT02956460|Primary|Vision Quality|Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear|2 weeks||||units on a scale||Standard Deviation|Mean
1304659|NCT02974114|Primary|Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)|The reaction time of five-choice reaction time task (provided by Cambridge Cognition) was measured. In five-choice reaction time task, all the participants hold down a button at the bottom of the screen till a yellow spot appears in one of the five circles at the top of the screen. Participants then released the button and touch inside of the circle where the yellow spot appeared as quickly as they can. The median duration, between the onset of the stimulus and the release of the button, was recorded as reaction time. Calculated for correct, assessed trials where the stimulus appeared in any one of five locations.|At Day 2 (pre and post-treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||msec||Full Range|Median
1304660|NCT02974114|Primary|Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)|Error adjusted SRT was one of the main outcomes of the Axon Sports Priming Application. The Axon Sports Priming Application is a computerized test performed on a tablet device that measures cognitive performance, namely psychomotor speed. Axon sports test assessment included 1. Pain-state assessment performed at Visit 2 (Day 2 pre-treatment assessment and post-treatment assessment 1hour [hr] ± 15 minutes [mins] post-dosing) and 2. Pain-free assessment performed at Visit 3 (Day 3).|At Day 2 (pre and post-treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||milliseconds (msec)||Full Range|Median
1304661|NCT02973100|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide|AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.|0, 2, 4, 6, 10, 18, 22 weeks and early termination|All randomized participants who received at least one dose of the study drug and have evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||90% Confidence Interval|Mean
1304662|NCT02973100|Secondary|Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide|Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.|0, 2, 4, 6, 10, 18, 22 weeks and early termination|All randomized participants who received at least one dose of the study drug and have evaluable PK data.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Mean
1304663|NCT02973100|Secondary|Rate of Documented Symptomatic Hypoglycemia|Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.|Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue values for hypoglycemic episodes.|||Episodes/participant/365.25 days||Standard Error|Least Squares Mean
1304664|NCT02973100|Secondary|Percentage of Participants Discontinuing Study Drug Due to Adverse Events|Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.|Baseline through Week 18|All randomized participants who received study drug and had postbaseline data for safety analyses.|||Percentage of Participants|||Number
1304665|NCT02973100|Secondary|Change From Baseline in Body Weight|Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.|Baseline, Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for body weight.|||Kilograms (Kg)||Standard Error|Least Squares Mean
1304666|NCT02973100|Secondary|Change From Baseline in Fasting Serum Glucose (FSG)|Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.|Baseline, Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for FSG.|||millimole/liter (mmol/L)||Standard Error|Least Squares Mean
1304667|NCT02973100|Secondary|Percentage of Participants With HbA1c of <7.0%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.|Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.|||Percentage of Participants|||Number
1304668|NCT02973100|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)|"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects."|Baseline, Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1304669|NCT02971670|Secondary|Boosterability of BioMed rTSST-1 Variant Vaccine|ELISA IgG against rTSST-1. Boosterability was defined as an increase in TSST-1 Ab titer as compared to antibody titers after second vaccination.|through 6 months after third immunization|Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.|||Participants|||Count of Participants
1304770|NCT02956460|Primary|Overall Dryness|Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness|2 weeks||||units on a scale||Standard Deviation|Mean
1304673|NCT02968173|Secondary|Total Days of Mechanical Ventilation During RSV-hospitalization||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
1304674|NCT02968173|Secondary|Percentage of Participants Who Received Mechanical Ventilation||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
1304675|NCT02968173|Secondary|Total Days of RSV-ICU Stay||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
1304676|NCT02968173|Secondary|Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
1304677|NCT02968173|Secondary|Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement|Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.|Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
1304678|NCT02968173|Secondary|Percentage of Participants Who Received Supplemental Oxygen While Hospitalized|Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.|Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
1304679|NCT02968173|Secondary|Total Number of RSV-Hospitalization Days||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
1304680|NCT02968173|Primary|Percentage of Participants With RSV Hospitalization|An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).|Approximately 6 months||||percentage of participants||95% Confidence Interval|Number
1304681|NCT02968134|Primary|Posaconazole Exposure Described as Area Under the Total Plasma Concentration-time Curve From Time Zero to Infinity After a Single Dose|The primary outcome is plasma posaconazole exposure expressed as the area under the total plasma concentration-time curve from time zero to infinity resulting from a single dose of 300 mg of posaconazole administered intravenously.|48 hours||||ng*h/mL||Inter-Quartile Range|Median
1304682|NCT02967393|Secondary|Number Participants With Asthma Exacerbations Requiring Medical Attention|For the purpose of this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath/dyspnea, cough, wheezing, chest tightness, and/or respiratory distress during the 42 days post-vaccination (until day 43) for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization)|42 days||||Participants|||Count of Participants
1304683|NCT02967393|Secondary|Number of Asthma Exacerbations Requiring Steroids|For the purpose of this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath/dyspnea, cough, wheezing, chest tightness, and/or respiratory distress during the 42 days post-vaccination (until day 43) for which the patient receives a new prescription for systemic corticosteroids..|42 days||||number of events|||Number
1304684|NCT02967393|Secondary|Unsolicited and Severe Adverse Events|The nature and frequency of the unsolicited and Severe adverse events will be described in children receiving ccIIV4 and IIV4 during the 42 days after vaccination.|42 days||||number of events|||Number
1304685|NCT02967393|Secondary|Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination|Number of solicited severe (not serious) systemic reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.|14 days||||number of events|||Number
1304686|NCT02967393|Secondary|Severe Local Reactogenicity Events During the 14 Days Post-vaccination|Number of severe local reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.|14 days||||number of events|||Number
1304687|NCT02967393|Primary|Feasibility Benchmark: Number of Parents Completing a Satisfaction Survey|Parent of each participant will be asked to complete a at the end of the study|42 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304688|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 44 Call|Number of parents that respond to Day 44 ( Plus 3 Days) call and provide requested data.|Day 44-47|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304689|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 29 Call and Provide Requested Data.|Number of Parents that respond to Day 29 ( Plus 2 Days) call and provide requested data.|Day 29-31|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304690|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 15 Call and Provide Requested Data|Number of parents that respond to Day 15 (minus 1 or plus 2 days) call and provide requested data|Day 14 to 17|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304771|NCT02956460|Primary|Overall Comfort|Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel|2 weeks||||units on a scale||Standard Deviation|Mean
1304691|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 8 Call and Provide Requested Data.|Number of parents that respond to Day 8 (plus 2 days) call and provide requested data.|Day 8-10|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304692|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 4 Call and Provide Requested Data|Number of parents that respond to Day 4 ( -1 day or + 2 days) call and provide requested data|Day 3 to 6|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304693|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Document Nighttime Awakenings|Number of parents that document nighttime awakenings for at least 11 of the 15-day monitoring period.|15 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304694|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42|Parent will perform and document the digital peak flow for Day 42|Day 42|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received.. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304695|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements|Number of parents that perform and document all home digital peak flow measurements at least 11 days out of the 15-day monitoring period.|15 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304696|NCT02967393|Primary|Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data|Parent will collect the following data: need for new prescription or nonprescription medications for the control of asthma, an unscheduled healthcare provider visit or consultation within 42 days after vaccination, any other clinically significant event occurring at any point during the study period. Serious Adverse Events (SAEs) will also be monitored through 42 days after vaccination and will include events that result in death, were life threatening, result in subject hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity. Additionally, important medical events that may not have resulted in death, were not life threatening, or did not require hospitalization might be considered SAEs when, according to appropriate medical judgment, they jeopardize the patient or subject and require medical or surgical intervention to prevent one of the outcomes listed above.|Day 16 to 43|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304697|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.|Memory aid 1 is a diary completed by the subjects Parent. Daily symptoms, peak flow and requires the parent to record daily symptoms, peak flow, days, post-vaccination asthma clinical symptoms and symptom scores, adverse event, fever and concomitant medication administration data for 14 days (until day 15) after vaccination.|15 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
1304698|NCT02967354|Secondary|Hepatic Fat Content||Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan or insufficient image quality.|||% of liver volume||Standard Deviation|Mean
1304699|NCT02967354|Secondary|Pancreatic Fat Content||Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan, pancreatic anatomical abnormality or insufficient image quality.|||% of pancreatic volume||Standard Deviation|Mean
1304700|NCT02967354|Secondary|Pancreatic Volume||Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some participants were not included in the analysis because of not being able to participate in the imaging, pancreatic anatomical abnormality or insufficient image quality.|||cm^3||Standard Deviation|Mean
1304701|NCT02967354|Secondary|Pancreatic Perfusion|Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release|Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some individuals in the study population were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.|||ml/min||Standard Deviation|Mean
1304702|NCT02967354|Primary|[11C]5-hydroxy-tryptophan Uptake in the Pancreas|Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release|Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|"Two healthy controls and two individuals in the group Normal weight, treated with oral antidiabetic drugs + insulin were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality."|||% of injected dose||Standard Deviation|Mean
1304703|NCT02966509|Secondary|Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey|Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.|6 months||||units on a scale||Standard Deviation|Mean
1304796|NCT02951702|Secondary|Time to Clostridium Difficile Infection Occurence|This is the time from the start of antibiotics to the diagnosis of clostridium difficile.|Within 4 weeks from completion of antibiotic treatment||||days||Full Range|Mean
1350635|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 12||||nmol/L||Standard Deviation|Mean
1304704|NCT02966509|Secondary|Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey|Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher scores indicating higher ratings. Scores for each group are averaged at baseline and at 6 months.|Change in Patient Satisfaction with Care from baseline to 6 months.||||units on a scale||Standard Deviation|Mean
1304705|NCT02966509|Secondary|Palliative Care Referral (Chart Review)|Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.|15 months after patient enrollment||||Participants|||Count of Participants
1304706|NCT02966509|Secondary|Palliative Care Referral (Chart Review)|Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||Participants|||Count of Participants
1304707|NCT02966509|Secondary|Hospice Referral (Chart Review)|Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||Participants|||Count of Participants
1304708|NCT02966509|Secondary|Hospitalization Visits (Chart Review)|Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.|15 months after patient enrollment||||Visits||Standard Deviation|Mean
1304709|NCT02966509|Secondary|Hospitalization Visits (Chart Review)|Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||Visits||Standard Deviation|Mean
1304710|NCT02966509|Secondary|Emergency Department Visit (Chart Review)|Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.|15 months after patient enrollment||||Visits||Standard Deviation|Mean
1304711|NCT02966509|Secondary|Emergency Department Visit (Chart Review)|Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||visits||Standard Deviation|Mean
1304712|NCT02966509|Primary|Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.|Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.|6 months after each patient enrollment||||Participants|||Count of Participants
1304713|NCT02966015|Primary|Number of Participants Successfully Able to Insert Catheter|"The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: How did you find the catheter navigates through the urethra during insertion ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'."|1 week||||Participants|||Count of Participants
1304714|NCT02966002|Secondary|Quality of Life|The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status.|8 weeks||||units on a scale||Standard Deviation|Mean
1304715|NCT02966002|Secondary|High Sensitivity CRP(C-Reactive Protein)|Change will be measured from baseline to retest after 8 weeks of treatment|8 weeks||||mg/dL||Standard Deviation|Mean
1304716|NCT02966002|Primary|Change in HDL (High-Density Lipoprotein)-Cholesterol|Change will be measured from baseline to retest after 8 weeks of treatment|8 weeks||||mg/dL||Standard Deviation|Mean
1304717|NCT02966002|Primary|Change in Total Cholesterol|Change will be measured from baseline to retest after 8 weeks of treatment|8 weeks||||mg/dL||Standard Deviation|Mean
1304718|NCT02965833|Primary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30|CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.|Day 30, each product|Full Analysis Set with non-missing responses|||units on a scale||Standard Deviation|Mean
1304719|NCT02965820|Primary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30|CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.|Day 30, each product|Full Analysis Set with non-missing responses|||units on a scale||Standard Deviation|Mean
1304720|NCT02964767|Secondary|Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.|CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.|12 months||||cells/µL||Standard Deviation|Mean
1304721|NCT02964767|Primary|Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.|% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%|12 months||||participants|||Number
1304722|NCT02962882|Secondary|Wear Time (Days) for First Dressing|Maximum length of wear time/stay on ability of dressings in ICU.|4-6 days|ITT population|||Participants|||Count of Participants
1304738|NCT02959840|Secondary|Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)|The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
1304723|NCT02962882|Primary|User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication|"User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing?~*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits.~Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections)."|4-6 days|ITT population As a dressing change was not required at all visits, the total number of dressing changes will vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections).|||Number of dressing changes|Number of dressing changes||Count of Units
1304724|NCT02962882|Primary|User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication|"User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing~*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits.~Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections)."|4-6 days|ITT population As a dressing change was not required at all visits, the total number of dressing changes evaluated vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections).|||Dressing changes evaluated|Dressing changes evaluated||Count of Units
1304725|NCT02961244|Secondary|Maintaining Normothermia Rate|"Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed.~With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia)"|Surgery day|Patients and their results assessed on the basis of intention to treat per protocole.|||Participants|||Count of Participants
1304726|NCT02961244|Primary|Surgical Site Infection Rate|"Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed.~All patients were made enough incision wide to explore their entire abdomen defined as Major Abdominal Surgery .~With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square )"|Postoperative 30 days|Patients and their results assessed on the basis of intention to treat per protocole.|||Participants|||Count of Participants
1304727|NCT02959996|Secondary|Patient Satisfaction With Pain Management at 6w Postpartum|Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used|6 weeks postpartum||||Participants|||Count of Participants
1304728|NCT02959996|Secondary|Operative Time of Cesarean Delivery|Operative time of cesarean delivery|Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.||||hours||Inter-Quartile Range|Median
1304729|NCT02959996|Secondary|Number of Patients With Allergic Reaction Attributable to Local Anesthestic|incisional rash, hives, anaphylaxis|0-96 hours postoperatively||||Participants|||Count of Participants
1304730|NCT02959996|Secondary|Number of Patients With Wound Complication - Separation, Dehiscence, Infection|Wound complication - separation, dehiscence, infection|14 days postoperatively||||Participants|||Count of Participants
1304731|NCT02959996|Secondary|Postoperative Hospital Length of Stay|Postoperative hospital length of stay|0 to 96 hours postoperatively||||days||Standard Deviation|Mean
1304732|NCT02959996|Secondary|Satisfaction With Post-operative Pain Control|PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied|48-hours post-operatively||||units on a scale||Inter-Quartile Range|Median
1304733|NCT02959996|Secondary|Total Opioid Use (in Morphine Equivalents)|Total opioid use (in morphine equivalents)|72-hours post-operatively||||morphine milligram equivalents (MME)||Inter-Quartile Range|Median
1304734|NCT02959996|Secondary|Pain Score With Activity|"Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain.~4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment"|at 72 -hours post-operatively||||units on a scale||Inter-Quartile Range|Median
1304735|NCT02959996|Primary|Pain Score With Activity|"Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain.~2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39"|at 48-hours post-operatively||||units on a scale||Inter-Quartile Range|Median
1304736|NCT02959840|Secondary|Overall Anesthetic Care Satisfaction|Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.|During the surgical procedure||||Participants|||Count of Participants
1304737|NCT02959840|Secondary|Satisfaction of Anti-emetic Treatment|Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.|During the surgical procedure||||Participants|||Count of Participants
1306241|NCT02765269|Secondary|Users' Satisfaction (Questionnaire)|Patients will be asked to complete a questionnaire after patients use it for 2 weeks.|2 weeks||||participants|||Number
1304739|NCT02959840|Secondary|Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)|The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
1304740|NCT02959840|Secondary|Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)|The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
1304741|NCT02959840|Secondary|Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)|The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
1304742|NCT02959840|Secondary|Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
1304743|NCT02959840|Secondary|Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
1304744|NCT02959840|Secondary|Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
1304745|NCT02959840|Secondary|Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
1304746|NCT02959840|Primary|Vomiting|The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
1304747|NCT02959840|Primary|Nausea|The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.|During the surgical procedure||||Participants|||Count of Participants
1304748|NCT02958995|Primary|Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes|The association between diabetes and risk of each of the 10 most common cancers was assessed by calculating hazard ratio using Cox proportional hazards regression models with control for available potential confounders: age, gender and calendar years. Cox regression techniques was used to examine the association between DM status and cancer risk with adjustment for potential confounding variables in the survey respondent cohort.|15 years|Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.|||Ratio||95% Confidence Interval|Number
1304749|NCT02958995|Primary|Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status|Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.|15 years|Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.|||Incidence per 100,000 person-years||95% Confidence Interval|Number
1304750|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases By Dose of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and >=50001 mg.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.The unexposed arm was not planned to be analyzed for this outcome measure.|||Cases|||Number
1304765|NCT02956460|Primary|Conjunctival Staining|"Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.~0=None, no staining present~Very slight~Slight~Moderate~Severe"|2 weeks||||units on a scale||Standard Deviation|Mean
1304766|NCT02956460|Primary|Lens Centration|Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).|2 weeks||||Participants|||Count of Participants
1304767|NCT02956460|Primary|Vision Satisfaction|Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.|2 weeks||||units on a scale||Standard Deviation|Mean
1304751|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
1304752|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases by Duration of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.|||Cases|||Number
1304753|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
1304754|NCT02958956|Secondary|Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone|Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.|||Cases|||Number
1304755|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. The various times since initiation include <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
1304756|NCT02958956|Primary|Number of 10 Most Common Cancers Associated Cases|Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Cases|||Number
1304757|NCT02958956|Primary|Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. Cox proportional hazards regression modeling was used to provide point and interval estimates of the relative hazard of the 10 most common cancers associated with ever use of pioglitazone. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
1304758|NCT02958787|Primary|The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids|"The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids.~Scoring:~Sexually active without aids~Sexually active with aids~Not sexually active with or without aids"|5 years from end of radiation treatment||||percentage of patients||95% Confidence Interval|Number
1304759|NCT02958345|Secondary|GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre)|Change in pre and post vaccination Varicella Zoster Virus|Day 1 and 6 weeks|Data was not available for analysis due to laboratory processing error.||||||
1304760|NCT02958345|Primary|ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay|Change in vitro cell-mediated immune response to varicella virus before and after vaccination in subjects receiving Zostavax™ versus those receiving placebo.|Day 1 and 6 weeks|Data was not available for analysis due to laboratory processing error.||||||
1304761|NCT02956460|Primary|Lens Wettability|Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable|2 weeks||||units on a scale||Standard Deviation|Mean
1304762|NCT02956460|Primary|Lens Hydrated|Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated|2 weeks||||units on a scale||Standard Deviation|Mean
1304763|NCT02956460|Primary|Clean Feeling|Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean|2 weeks||||units on a scale||Standard Deviation|Mean
1304764|NCT02956460|Primary|Smoothness|Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth|2 weeks||||units on a scale||Standard Deviation|Mean
1304772|NCT02954601|Secondary|Calculate the Difference Between Values of Pre-treatment and End-of-treatment Mean Daytime CGM Glucose|Calculate the difference between pre-treatment (Day 3) and end of treatment (Day 8) mean daytime CGM glucose for single and multiple doses of ORMD-0801 vs placebo.|Day 3 and Day 8 (two timepoints)|Intend to Treat mean values reported for Doses 1, 2, and 3 are placebo-adjusted doses (Active dose mean minus placebo dose mean)|||mg/dL||Standard Error|Mean
1304773|NCT02954601|Secondary|The Number Hypoglycemic Events for Single and Multiple Doses of ORMD-0801 vs Placebo|The number of safety parameter hypoglycemic events for single and multiple doses of ORMD-0801 vs placebo.|Day 3 through Day 8 of treatment|Safety population|||number of hypoglycemic events|||Number
1304774|NCT02954601|Secondary|Calculate the C-peptide Ratio for Single and Multiple Doses of ORMD-0801 vs Placebo.|For each dose, calculate the ratio of the C-Peptide measurement area-under-the-curve (ng-hr/mL) Day 8 to the C-peptide measurement area-under-the-curve (ng-hr/mL) Day 3. This ratio is called the C-peptide Ratio.|Day 3 and Day 8|Intend to Treat (ITT)|||ratio||Standard Error|Mean
1304775|NCT02954601|Primary|Change in Glucose Levels Between Pre-treatment and End of Treatment as Measured by 24-hour Continuous Glucose Monitoring (CGM)|Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment)|Day 3 (run-in) and Day 8 (Day 5 of Active treatment)|Intend to Treat Population|||mg/dL||Standard Deviation|Mean
1304776|NCT02953886|Secondary|Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)|Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling.|One month||||Participants|||Count of Participants
1304777|NCT02953886|Primary|Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)|Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.|One month||||cervical lesions|||Number
1304778|NCT02953886|Primary|Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions|Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.|baseline, One month after SDF||||bacterial count|||Number
1304779|NCT02951884|Secondary|Supplemental Analgesia|Twenty-four hours after injury, the researchers will record the number of participants that required supplemental analgesia.|24 hours|The analysis population comprises both participants who consented to participate in the trial|||Participants|||Count of Participants
1304780|NCT02951884|Primary|Numerical Rating Scale (NRS) Pain Scores|Twenty-four hours after injury, patients will self report their numerical rating scale (NRS) score. The NRS score ranges from 0 to 10 with higher scores indicating greater pain.|24 hours|The analysis population comprises both participants who consented to participate in the trial|||units on a scale|||Number
1304781|NCT02951767|Secondary|Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab||Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.|||percentage of participants|||Number
1304782|NCT02951767|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)|Cohort 1 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.|||mcg/mL||Standard Deviation|Mean
1304783|NCT02951767|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)|Cohort 1 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.|||microgram(s)/milliliter (mcg/mL)||Standard Deviation|Mean
1304784|NCT02951767|Secondary|Percentage of Participants Alive at 1-year||1-year|Cohort 1 ITT population.|||percentage of participants||95% Confidence Interval|Number
1304785|NCT02951767|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to the time of death from any cause on study.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||months||95% Confidence Interval|Median
1304786|NCT02951767|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||percentage of participants|||Number
1304787|NCT02951767|Secondary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population.|||percentage of participants||95% Confidence Interval|Number
1304797|NCT02951702|Primary|Clostridium Difficile Infection Occurrence|The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal.|Within 4 weeks from the completion of antibiotic treatment||||Participants|||Count of Participants
1304889|NCT02941640|Primary|Overall Morbidity|Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day.|30 days||||Participants|||Count of Participants
1304788|NCT02951767|Secondary|PFS as Assessed by the Investigator According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||months||95% Confidence Interval|Median
1304789|NCT02951767|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||percentage of participants|||Number
1304790|NCT02951767|Secondary|Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||months||95% Confidence Interval|Median
1304791|NCT02951767|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||percentage of participants|||Number
1304792|NCT02951767|Secondary|DOR as Assessed by the Investigator According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
1304793|NCT02951767|Secondary|Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
1304794|NCT02951767|Primary|Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population included intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 1 ITT population included all participants from Cohort 1 who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1304795|NCT02951702|Secondary|Clostridium Difficile Infection Severity|Severity as defined by the IDSA/SHEA guidelines (mild to moderate, defined as white-cell count less than 15,000 cells/µL or increase in serum creatinine (SCr) by <1.5 times the baseline; severe, defined as white-cell count greater than 15,000 cells/µL or increase in SCr by >1.5 times the baseline; and fulminant, defined as the criteria above for severe with shock, hypotension, ileus, or megacolon)|Within 4 weeks from completion of antibiotic treatment||||participants|||Number
1304798|NCT02951312|Secondary|t1/2 Plasma Half-life|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.|0 to 12 hours post-dose|"Subjects who received at least one dose of study medication and have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.Subject received more than one treatment type throughout the study~samples taken to obtain a plasma concentration by time profile were included in the PK analysis."|||hour||Standard Deviation|Mean
1304799|NCT02951312|Secondary|AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours post dose|All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.|||pg*h/mL||Standard Deviation|Mean
1304800|NCT02951312|Secondary|AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hourr post dose|All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.A subject received more than one treatment type throughout the study.|||pg*h/mL||Standard Deviation|Mean
1304801|NCT02951312|Secondary|Tmax Time to Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours post dose|All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.|||hours||Standard Deviation|Mean
1304802|NCT02951312|Secondary|Cmax Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours post dose|"All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK . A subject received more than one treatment type throughout the study.~analysis."|||pg/mL||Standard Deviation|Mean
1304803|NCT02951312|Secondary|FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|0 to 24hr post dose|All subjects who received at least one dose of study medication and have at least one post baselineefficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.|||liters||Standard Deviation|Mean
1304804|NCT02951312|Secondary|Peak FEV1 (Change From Baseline )|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|0 to 4hr|All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population.. A subject received more than one treatment type throughout the study.|||liters||Standard Deviation|Mean
1304805|NCT02951312|Secondary|Peak FEV1 (Percent Change)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|0 to 4hr|all subjects who received at least one dose of the study medication and have at least one post baseline efficacy measurement were included in the efficacy population. . A subject received more than one treatment type throughout the study.|||percent change||Standard Deviation|Mean
1304806|NCT02951312|Secondary|Trough FEV1 (Change From Baseline)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the spirometry value collected at 24 hours post dose within each Treatment Period.|24hr post dose|All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.|||liters||Standard Deviation|Mean
1304807|NCT02951312|Primary|Number of Subjects With Treatment Emergent AEs|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study|||Participants|||Count of Participants
1304808|NCT02951312|Primary|Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study|Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.|post study follow-up assessment (Day 47)|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
1304809|NCT02951312|Primary|Number of Subjects With Clinically Significant ECG Parameters Reported During the Study|ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.|30hr post dose|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study|||Participants|||Count of Participants
1304810|NCT02951312|Primary|Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study|Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.|day 47 (post studyfollow-up assessment)|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
1305029|NCT02917642|Primary|Bacterial Levels|Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay|Through study completion, an average of 2 years||||DNA copies||Full Range|Median
1304811|NCT02951312|Primary|Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study|Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.|30 hrs post dose|all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
1304812|NCT02951312|Primary|Percentage of Subjects With Treatment Emergent AEs|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.|||percentage of participants|||Number
1304813|NCT02951312|Primary|Number of Subjects Who Discontinued Due to AE|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
1304814|NCT02951312|Primary|Number of Subjects With Treatment Emergent SAEs|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
1304815|NCT02951312|Primary|Number of Subjects Who Died||0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
1304816|NCT02951273|Secondary|Changes in Stroke Volume From Baseline Before Induction of Anaesthesia.|Stroke volume [ml] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||ml||95% Confidence Interval|Mean
1304817|NCT02951273|Secondary|Changes in Cardiac Output From Baseline Before Induction of Anaesthesia.|Cardiac output [l/min] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||l/min||95% Confidence Interval|Mean
1304818|NCT02951273|Secondary|Changes in Mean Arterial Pressure From Baseline Before Induction of Anaesthesia.|Mean arterial pressure [mmHg] as recorded continuously by a transducer connected to an arterial line.|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||mmHg||95% Confidence Interval|Mean
1304819|NCT02951273|Secondary|Changes in Heart Rate From Baseline Before Induction of Anaesthesia.|Heart rate [bpm] as recorded continuously by a transducer connected to an arterial line.|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||beats/min||95% Confidence Interval|Mean
1304820|NCT02951273|Secondary|Changes in the CO2 Reactivity of the Internal Carotid Artery From Before to After Induction of Anaesthesia.|"Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound and arterial CO2 tension (PaCO2) [kPa] was evaluated by gas analysis. Changes in PaCO2 are guided by evaluation of end-tidal CO2 tension.~The CO2 reactivity to hypocapnia when awake and during anaesthesia is calculated as the percentage change in internal carotid artery blood flow per kPa change in PaCO2. The CO2 reactivity when awake and when anaesthetized is compared."|Four measurements; before induction of anaesthesia during normoventilation and during hyperventilation to reduce PaCO2 by 1.5 kPa and during anaesthesia at a PaCO2 at the value before induction of anaesthesia and 1.5 kPa below that value.|Comparison of reactivity to hypocapnia when awake and during anaesthesia was evaluated by a linear mixed model with the relative change in ICA flow as outcome and fixed effects were the change in PaCO2 and an interaction factor for the difference between awake and anaesthesia. The reported result is the interaction factor.|||%/kPa||95% Confidence Interval|Mean
1304821|NCT02951273|Secondary|Changes in Internal Carotid Artery Blood Flow by Development of Mesenteric Traction Syndrome (MTS).|Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||ml/min||95% Confidence Interval|Mean
1304822|NCT02951273|Secondary|Changes in Forehead Skin Oxygenation by Development of Mesenteric Traction Syndrome (MTS).|Forehead skin oxygenation [%] assessed by laser Doppler flowmetry as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||oxygenation [%]||95% Confidence Interval|Mean
1304890|NCT02939170|Secondary|Limbal Hyperemia|Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.|Day 1 at Hour 9|Safety Analysis Set|||Eyes|Eyes||Count of Units
1304823|NCT02951273|Secondary|Changes in Forehead Skin Blood Flow by Development of Mesenteric Traction Syndrome (MTS).|Forehead skin blood flow [PU] assessed by laser Doppler flowmetry as compared between those patients who develop mesenteric traction syndrome (defined as flushing within 60 min after the start of surgery) and those who do not. Laser Doppler flowmetry applies a laser placed on the forehead that penetrates the skin and is scattered with a Doppler shift by the red blood cells and return to a detector that evaluates the amount of backscattered light and Doppler shift. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||PU||95% Confidence Interval|Mean
1304824|NCT02951273|Secondary|Changes in Frontal Lobe Oxygenation by Development of Mesenteric Traction Syndrome (MTS).|Near-infrared spectroscopy determined frontal lobe oxygenation [%] as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||oxygenation [%]||95% Confidence Interval|Mean
1304825|NCT02951273|Secondary|Association by Multiple Regression Between Changes in Internal Carotid Artery Blood Flow, Mean Arterial Pressure and Cardiac Output by Treatment of Anaesthesia-induced Hypotension.|"Association by multiple regression between changes in unilateral internal carotid artery blood flow [ml/min] as outcome variable and changes in mean arterial pressure [mmHg] and cardiac output [l/min] as covariates.~Internal carotid artery blood flow [ml/min] was assessed by duplex ultrasound. Mean arterial pressure [mmHg] was recorded by a transducer connected to an arterial line. Cardiac output [l/min] was evaluated by pulse contour analysis (Modelflow) that estimates cardiac output by analysis of the arterial pressure curve taking age, gender, height and weigth into account."|Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.||||ml/min||Standard Deviation|Least Squares Mean
1304826|NCT02951273|Secondary|Changes in Internal Carotid Artery Blood Flow by Induction of Anaesthesia.|Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound.|Two measurements; one measurement 5-10 min before induction of anaesthesia and one measurement 5-20 min after induction of anaesthesia.||||ml/min||95% Confidence Interval|Mean
1304827|NCT02951273|Primary|Changes in Internal Carotid Artery Blood Flow by Treatment of Anaesthesia-induced Hypotension|Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound.|Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.||||ml/min||95% Confidence Interval|Mean
1304828|NCT02949141|Primary|Diagnosis of Pneumonia|Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.|9 months|62|||Participants|||Count of Participants
1304829|NCT02948582|Secondary|Percentage of Subjects With Treatment Emergent AEs|AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment|Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)|all subjects who received at least one dose of study drug were included in the safety analysis|||percentage of participants|||Number
1304830|NCT02948582|Secondary|Number of Subjects With Clinically Significant ECG Parameters Reported During the Study|ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.|0 to 24h|all subjects who received at least one dose of study drug were included in the safety analysis|||Participants|||Count of Participants
1304831|NCT02948582|Secondary|Number of Clinically Significant Abnormal Laboratory Results Reported During the Study|Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators.|Day -14, Day 69|all subjects who received at least one dose of study drug were included in the safety analysis|||number of events|||Number
1304832|NCT02948582|Secondary|Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study|Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.|0-24 h|all subjects who received at least one does of study drug were included in the safety analysis|||Participants|||Count of Participants
1304833|NCT02948582|Secondary|Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE|AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment|Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)|all subjects who received at least one dose of study drug were included in the safety analysis|||participants|||Number
1304834|NCT02948582|Secondary|AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||pg.h/ml||Geometric Coefficient of Variation|Geometric Mean
1304849|NCT02947022|Secondary|Change in ACPA QOL Score at Month 6|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 6|Data were not analyzed because this study was stopped prematurely.||||||
1304835|NCT02948582|Secondary|AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||pg.h/ml||Geometric Coefficient of Variation|Geometric Mean
1304836|NCT02948582|Secondary|t1/2; Plasma Half-life|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
1304837|NCT02948582|Secondary|Tmax; Time to Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||hours||Full Range|Median
1304838|NCT02948582|Secondary|Cmax; Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1304839|NCT02948582|Primary|Peak FEV1 (Change From Baseline and Percent Change)|spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1.|0-4h post dose|all subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population|||liters||Standard Deviation|Mean
1304840|NCT02948582|Primary|Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1.|0 to 24h|all subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis|||liters||Standard Deviation|Mean
1304841|NCT02948582|Primary|Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1.|12-24h post dose|All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis|||liters||Standard Deviation|Mean
1304842|NCT02948582|Primary|Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1.|0-12h post dose|All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis|||liters||Standard Deviation|Mean
1304843|NCT02948582|Primary|Trough FEV1 (Change From Baseline)|"Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.~Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit."|24hr post dose|All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent-to-treat analysis.|||liters||Standard Deviation|Mean
1304844|NCT02947984|Secondary|Local Failure Rate|The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.|15 Years|Failure rates are shown by dose group in the overall study population and by treatment indication subgroups.|||participants|||Number
1304845|NCT02947984|Secondary|Late Toxicities|The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.|5 Years||||participants|||Number
1304846|NCT02947984|Secondary|Acute Toxicities|The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.|90 Days||||participants|||Number
1304847|NCT02947984|Primary|Progression Free Survival|The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.|5, 10, 15 years|Progression free survival in the entire cohort and by radiation indication sub-groups|||percentage of participants surviving||95% Confidence Interval|Number
1304848|NCT02947022|Secondary|Change in ACPA QOL Score at Month 12|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 12|Data were not analyzed because this study was stopped prematurely.||||||
1304850|NCT02947022|Secondary|Change in ACPA QOL Score at Month 3|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 3 (day 7)|Data were not analyzed because this study was stopped prematurely.||||||
1304851|NCT02947022|Secondary|Change in ACPA QOL Score From Baseline to Month 2|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 2 (day 7)|Data were not analyzed because this study was stopped prematurely.||||||
1304852|NCT02947022|Secondary|Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 1 (day 7)|Data were not analyzed because this study was stopped prematurely.||||||
1304853|NCT02947022|Secondary|Change From Baseline to Month 12 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 12|Data were not analyzed because this study was stopped prematurely.||||||
1304854|NCT02947022|Secondary|Change From Baseline to Month 6 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 6|Data were not analyzed because this study was stopped prematurely.||||||
1304855|NCT02947022|Secondary|Change From Baseline to Month 3 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 3 (Day 7)|Data were not analyzed because this study was stopped prematurely.||||||
1304856|NCT02947022|Secondary|Change From Baseline to Month 2 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 2 (Day 7)|Data were not analyzed because this study was stopped prematurely.||||||
1304857|NCT02947022|Secondary|Change From Baseline to Month 1 in the Pain Score|"Patient self-reported pain scores assessed using a Visual Analog Scale (VAS) ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 1 (Day 7)|Data were not analyzed because this study was stopped prematurely.||||||
1304858|NCT02947022|Secondary|Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.||Baseline, Month 3|Data were not analyzed because this study was stopped prematurely.||||||
1304859|NCT02947022|Secondary|Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.||Baseline, Month 3|Data were not analyzed because this study was stopped prematurely.||||||
1304860|NCT02947022|Secondary|Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.||Baseline, Month 2|Data were not analyzed because this study was stopped prematurely.||||||
1304861|NCT02947022|Secondary|Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.||Baseline, Month 2|Data were not analyzed because this study was stopped prematurely.||||||
1304862|NCT02947022|Primary|Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.||Baseline, Month 1|Data were not analyzed because this study was stopped prematurely.||||||
1304863|NCT02947022|Primary|Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.||Baseline, Month 1|Data were not analyzed because this study was stopped prematurely.||||||
1304864|NCT02945254|Secondary|Subjective Sleep Quality (VAS)|subjective sleep quality was assessed in the morning with a visual analog scale (VAS) ranging from 1 (worse quality) to 10 (best quality)|1 night||||units on a scale||Inter-Quartile Range|Median
1304865|NCT02945254|Primary|Sleep Onset Latency (Mins)|time from lights out to the first epoch of stage 2 NREM sleep|1 night||||minutes||Inter-Quartile Range|Median
1304866|NCT02943226|Secondary|Injection Flow Rate|The injection flow rate is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.|at the time of CT scanning||||milliliters per second (mL/sec)||Standard Deviation|Mean
1304867|NCT02943226|Secondary|Peak Contrast Infusion Pressure|The peak contrast infusion pressure is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.|at the time of CT scanning|"Peak contrast infusion pressure data was not collected by the technologist for one patient in the Standard intravenous non-fenestrated catheter arm."|||Pounds per square inch (PSI)||Inter-Quartile Range|Median
1304868|NCT02943226|Primary|Image Quality as Assessed by Rating Scale|Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome.|at the time of CT scanning||||units on a scale||Standard Deviation|Mean
1304869|NCT02943226|Primary|Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta|The ratio of tissue density measured in the inferior vena cava (IVC) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.|at the time of CT scanning||||Ratio||Standard Deviation|Mean
1304886|NCT02941640|Secondary|Operative Time|Time of operative procedure|120 min.||||minutes||Standard Deviation|Mean
1304887|NCT02941640|Secondary|Postoperative Complications|Complications that appear after operative procedure|30 days||||Participants|||Count of Participants
1304888|NCT02941640|Secondary|Intra-perative Complications|Complications that appear during operative procedure|120 min.||||Participants|||Count of Participants
1304870|NCT02943226|Primary|Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta|The ratio of tissue density measured in the spleen to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.|at the time of CT scanning|"Data for the Becton Dickinson Nexiva Diffusics System fenestrated catheter arm was not collected for one patient because the patient had a splenectomy."|||Ratio||Standard Deviation|Mean
1304871|NCT02943226|Primary|Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta|The ratio of tissue density measured in the main portal vein (MPV) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.|at the time of CT scanning||||Ratio||Standard Deviation|Mean
1304872|NCT02943213|Secondary|Apparent Terminal Elimination Half-life (t1/2) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
1304873|NCT02943213|Secondary|Apparent Terminal Elimination Half-life (t1/2) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
1304874|NCT02943213|Secondary|Terminal Elimination Rate Constant (λz) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1304875|NCT02943213|Secondary|Terminal Elimination Rate Constant (λz) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1304876|NCT02943213|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Full Range|Median
1304877|NCT02943213|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Full Range|Median
1304878|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1304879|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1304880|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1304881|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1304882|NCT02943213|Primary|Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1304883|NCT02943213|Primary|Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1304884|NCT02941640|Secondary|Hospital Stay|Length of hospitalization|30 days||||days||Standard Deviation|Median
1304885|NCT02941640|Secondary|Time of Application|Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix|120 min||||seconds||Standard Deviation|Mean
1304891|NCT02939170|Secondary|Ocular Staining|Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.|Day 1 at Hour 9|Safety Analysis Set|||Eyes|Eyes||Count of Units
1304892|NCT02939170|Primary|Incidence of Ocular Discomfort Device-related Adverse Events (AE)|An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as “Related” to study device and deemed to be related to ocular discomfort.|Day 1 at Hour 9|Safety Analysis Set|||Events|Eyes||Number
1304893|NCT02937870|Secondary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
1304894|NCT02937870|Secondary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
1304895|NCT02937870|Secondary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
1304896|NCT02937870|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
1304897|NCT02937870|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on intent-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
1304898|NCT02937623|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours|Participants rated the intensity of their response to the evaporative air stimulus using a 10 point numerical rating scale of 1 (No Pain) to 10 (Intense Pain).|At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1304899|NCT02937623|Secondary|Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline (pre-treatment), the maximum force used was 20g; at all subsequent time points (post treatment), it was 80g.|At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||gram (g)||Standard Deviation|Mean
1304915|NCT02934347|Secondary|The Use of Ancillary Equipment|The use of ancillary equipment (e.g. bougie, alternative laryngoscope blades) and manoeuvres (e.g. laryngeal manipulation) were recorded but applied at the intubating anaesthetist’s discretion|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia|||participants|||Number
1304916|NCT02934347|Secondary|The Number of Attempts at Both Laryngoscopy and Tracheal Intubation|The number of attempts at both laryngoscopy and tracheal intubation were recorded|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia|||participants|||Number
1304900|NCT02937623|Secondary|Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1304901|NCT02937623|Primary|Change From Baseline in Schiff Sensitivity Score After 10 Minutes|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1304902|NCT02937506|Primary|Patient Satisfaction|Satisfaction assessed using self-developed questionnaire.|Patient satisfaction was assessed the day of the procedure.|Same as enrolled.|||Participants|||Count of Participants
1304903|NCT02935894|Secondary|Change in Sweat Ibuprofen Concentrations|Sweat concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration|measured at four timepoints at study visit 4|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||micrograms per milliliter||Full Range|Geometric Mean
1304904|NCT02935894|Secondary|Change in Plasma Ibuprofen Concentrations|Plasma concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration|measured at four timepoints at study visit 4|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||micrograms per milliliter||Full Range|Geometric Mean
1304905|NCT02935894|Secondary|Change in Pilocarpine-stimulated Sweat Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration|Approximately 100 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids, and endocannabinoid-like molecules.|measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||picomoles per milliliter||Full Range|Geometric Mean
1304906|NCT02935894|Primary|Change in Plasma Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration|Approximately 100 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids, and endocannabinoid-like molecules.|measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||picomoles per milliliter||Full Range|Geometric Mean
1304907|NCT02935894|Primary|Anterior Distal Thigh Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 2, detected lipid mediator concentrations reported|Of the 14 subjects recruited for this study, only 4 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
1304908|NCT02935894|Primary|Lower Back Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 1, detected lipid mediator concentrations reported|Of the 14 subjects recruited for this study, only 4 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
1304909|NCT02935894|Primary|Volar Forearm Sweat Lipid Mediator Concentrations Following Exercise|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 1, detected lipid mediator concentrations reported|Of the 14 subjects recruited for this study, only 7 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
1304910|NCT02935894|Primary|Volar Forearm Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 1, 2 and 3; detected lipid mediator concentrations for study visit 1 reported|Of the 14 subjects recruited for this study, only 7 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
1304911|NCT02934698|Secondary|Sweat Chloride|Testing efficacy through gathering absolute change in sweat chloride from baseline through week 24|24 Weeks||||mmol/L||Full Range|Mean
1304912|NCT02934698|Secondary|Sputum Results|Achievement of mycobacterial culture conversion (negative culture)|24 weeks||||Participants|||Count of Participants
1304913|NCT02934698|Primary|Forced Expiratory Volume|Absolute change in percent predicted in 1 second FEV1 from baseline through week 24|24 weeks||||percentage of predicted||Full Range|Mean
1304914|NCT02934347|Secondary|The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor|The time between the beginning of laryngoscopy and detection of carbon dioxide on the end-tidal carbon dioxide monitor after the successful placement of the tracheal tube was recorded|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia|||seconds||Inter-Quartile Range|Median
1304917|NCT02934347|Primary|The Best Glottic View Obtained During Laryngoscopy|"The best glottic view obtained during laryngoscopy was assessed using the Cormack and Lehane classification by the anaesthetist performing the laryngoscopy.~The Cormack and Lehane classifies glottic views as follows: Grade 1: Most of the glottis is visible, Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen., Grade 3: Only the epiglottis is visible, Grade 4: No laryngeal structures are visible."|The view of the glottis was measured once while the patient was being intubated|Adult patients who required intubation as part of their routine anaesthesia|||participants|||Number
1304918|NCT02933476|Secondary|Gait Asymmetry|Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.|1 Month|One out of the five patients was on medication so was excluded from analysis.|||arb.units||Standard Deviation|Mean
1304919|NCT02933476|Secondary|Root Mean Square Velocity|Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.|1 Month|One out of the five patients was on medication so was excluded from analysis.|||deg/s||Standard Deviation|Mean
1304920|NCT02933476|Secondary|Unified Parkinson's Disease Rating Scale, Part III|We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome.|1 Month||||units on a scale||Standard Deviation|Mean
1304921|NCT02933476|Primary|Number of Patients Reporting Any Adverse Effects|Questionnaire asks patients to record any adverse effects they experienced.|1 Month||||Participants|||Count of Participants
1304922|NCT02929823|Primary|Clearing of Corneal Fluorescein Staining at Week 5|A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared|5 weeks|Full Analysis Set: All patients randomly assigned to receive double-masked study drug, who received at least 1 dose of study drug in the study eye, and who had at least 1 post-baseline assessment for the primary efficacy endpoint.|||Participants|||Count of Participants
1304923|NCT02928380|Secondary|Kapur (Olshan Modification) Index Scores for Denture Stability|Kapur (Olshan modification) Index scores were assessed to examine each denture (upper & lower) for its stability ability. Stability was measured using score of 0–4: 4= Excellent- when denture base offered no rocking on its supporting structures under pressure; 3= Good- when denture base had very slight rocking on its supporting structures under pressure; 2= Fair- when denture base had slight rocking on its supporting structures under pressure; 1= Poor- when denture base had moderate rocking on its supporting structures under pressure; 0= No stability- when denture base had extreme rocking under pressure. Higher the score, higher the stability ability of denture.|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1304924|NCT02928380|Secondary|Kapur (Olshan Modification) Index Scores for Denture Retention|Kapur (Olshan modification) Index scores were assessed to examine each denture (upper & lower) for its retention ability. Retention was measured as score of 0–5 to assess nature of resistance offered by denture to vertical pull & lateral force: 5=Excellent - denture offered excellent resistance to vertical pull and lateral force; 4= Very Good- denture offered very good resistance to vertical pull and lateral force; 3= Good- denture offered moderate resistance to vertical pull and lateral force; 2= Fair- denture offered moderate resistance to vertical pull and little or no resistance to lateral forces; 1= Poor- denture offers slight resistance to vertical pull and little or no resistance to lateral force; 0= No retention- when the denture was seated in place, it displaced itself. Higher the score, higher the retention ability of denture.|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1304925|NCT02928380|Secondary|Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability|Kapur (Olshan modification) Index score was assessed to examine each denture (upper & lower) for retention & stability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull & lateral force: 5=Excellent;4=Very Good;3=Good;2=Fair;1= Poor;0=No retention. Stability was measured as score of 0-4 to assess nature of rocking offered by denture base on its supporting structures under pressure:4=Excellent (no rocking);3=Good (very slight rocking);2=Fair (slight rocking);1=Poor (moderate rocking);0=No stability (extreme rocking). Composite Kapur (Olshan modification) Index scores was measured as the sum score of retention & stability for upper or lower dentures separately such that a sum score of zero represents no retention and stability and a sum score of 9 represents excellent retention and stability.|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1304926|NCT02928380|Secondary|Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive|Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).|up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||g||Standard Deviation|Mean
1305008|NCT02920957|Primary|Lens Wettability|Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
1304927|NCT02928380|Secondary|Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use|Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||g||Standard Deviation|Mean
1304928|NCT02928380|Primary|Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use|Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||gram (g)||Standard Deviation|Mean
1304929|NCT02927431|Secondary|Average Concentration (Cavg) of IV DNX|Cavg of IV DNX was to be derived from the PK samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited sample size.||||||
1304930|NCT02927431|Secondary|Time to Reach Cmax (Tmax) of IV DNX|Tmax of IV DNX was to be derived from the PK samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited PK parameters available.||||||
1304931|NCT02927431|Secondary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]) of IV DNX|AUC (0-t) of IV DNX was to be derived from the PK samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited sample size.||||||
1304932|NCT02927431|Secondary|Maximum Observed Plasma Concentration (Cmax) of Intravenous (IV) DNX|Cmax of IV DNX was to be derived from the Pharmacokinetics (PK) samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose. PK Population comprised of all participants who underwent blood PK sampling during the study and from whom one or more blood concentration was determined.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited sample size.||||||
1304933|NCT02927431|Secondary|Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)|Single 12-lead ECGs were obtained at Baseline and on the day of last dose during the study using an ECG machine that automatically calculates the heart rate (HR) and measures PR, QRS, QT, and QT duration corrected for heart rate (QTc). Number of participants with clinically significant abnormality in ECG are presented.|Up to 6 days|Safety Population|||Participants|||Count of Participants
1304934|NCT02927431|Secondary|Change From Baseline in Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Alkaline Phosphatase (ALP)|Blood samples were collected to evaluate ALT, AST and ALP at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||International unit per Liter (IU/L)||Standard Deviation|Mean
1304935|NCT02927431|Secondary|Change From Baseline in Total Bilirubin (T. Bilirubin), Creatinine and Direct Bilirubin (D. Bilirubin)|Blood samples were collected to evaluate T. Bilirubin, creatinine and D. Bilirubin at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||Micromole per Liter (µmol/L)||Standard Deviation|Mean
1304936|NCT02927431|Secondary|Change From Baseline in White Blood Cell Count (WBC) and Absolute Neutrophil Count (ANC)|Blood samples were collected to evaluate WBC and ANC at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||Giga cells per Liter (GI/L)||Standard Deviation|Mean
1304937|NCT02927431|Secondary|Change From Baseline in Albumin and Total Protein|Blood samples were collected to evaluate albumin and total protein at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||Gram per Liter (G/L)||Standard Deviation|Mean
1304938|NCT02927431|Secondary|Number of Participants With Any Non-serious Adverse Event (AE); Any Serious AE (SAE); Any AEs of Special Interest (AESIs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AESI were considered for analysis. Safety Population comprised of all participants who received at least 1 dose of study treatment.|Up to 45 Days|Safety Population|||Participants|||Count of Participants
1304939|NCT02927431|Secondary|Number of Participants With Improvement in Ordinal Scale of Clinical Efficacy Over Time|Number of participants with improvement in ordinal scale of clinical efficacy over time was to be assessed by: death, mechanical vent, in the ICU, non-ICU hospitalization, and hospital discharge.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304940|NCT02927431|Secondary|Number of Participants Used Antibiotics for Complications of Influenza|Complications of influenza such as bacterial pneumonia, pneumothorax, pleural effusion, acute respiratory distress syndrome (ARDS), myositis, encephalitis, myocarditis, and associated antibiotic use was recorded. Number of participants who reqruied use of associated antibiotics for complications of influenza is presented.|Up to 45 Days|IPP Population|||Participants|||Count of Participants
1304941|NCT02927431|Secondary|Number of Participants With Development of Septic Shock|Development of septic shock was to be assessed by occurrence of hypotension requiring vasopressive therapy and serum lactate level >2 millimeter (mm) after adequate fluid resuscitation. Number of participants with development of septic shock were planned to be presented.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304942|NCT02927431|Secondary|Number of Days of Stay in the Hospital|Number of days of stay in the hospital over treatment period and post treatment period was to be recorded.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304943|NCT02927431|Secondary|Number of Participants Requiring ICU Admission and Readmission|Number of participants requiring ICU admission during treatment period and after post treatment was to be recorded.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304944|NCT02927431|Secondary|Number of Days of Stay in the Intensive Care Unit (ICU)|Number of days of stay in the ICU over the treatment period and post treatment period was to be recorded.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304945|NCT02927431|Secondary|Time to Improvement of Ventilation Status|Time to improvement of ventilation status was assessed by modality, frequencies and durations of invasive and non-invasive ventilator support, duration of oxygen supplementation.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304946|NCT02927431|Secondary|Percentage of Participants With Improved Respiratory Status Over Time|The Respiratory Response was defined as meeting at least one of the following criteria, and maintained for 24 hours: return to pre-morbid oxygen requirement (participants with chronic oxygen use or ventilator support), or return to no requirement of supplemental oxygen, or respiratory rate <=24 per minute (without supplemental oxygen). Percentage of participants with improved respiratory status has been presented.|Up to 45 Days|IPP Population|||Percentage of Participants|||Number
1304947|NCT02927431|Secondary|Percentage of Participants With Clinical Response Over Time|The clinical response was defined as Hospital discharge due to clinical improvement OR normalization of temperature; and oxygen saturation; and respiratory status/heart rate/systolic blood pressure (normalization of 2 out of these 3 parameters). The clinical response based on vital signs/ventilation status required 24-hour confirmation. Considering 2-hour assessment window, the response confirmation period was 22 hours. Percentage of participants with positive clinical response are presented.|Up to 45 Days|IPP Population|||Percentage of Participants|||Number
1304948|NCT02927431|Secondary|Time to Improved Systolic Blood Pressure (SBP)|Time from first dose of treatment to time of SBP at >=90 millimeters of mercury (mmHg) was to be evaluated.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304949|NCT02927431|Secondary|Time to Improved Heart Rate|Time from first dose of treatment to time of heart rate <=100 beats per minute was to be evaluated.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304950|NCT02927431|Secondary|Time to Improved Oxygen Saturation|Time from first dose of treatment to time of improved oxygen saturation was to be calculated. A participant with a history of chronic hypoxia (without supplemental oxygen) satisfied normalization criteria for oxygen saturation if the value (without supplemental oxygen) is <=2 percent from participant’s historical oxygen saturation Baseline as recorded within 12 months prior to enrollment as documented in the participant’s medical records. This requirement was to be waived for participants with a history of chronic supplemental oxygen requirement who had a Baseline oxygen saturation <95 percent with supplemental oxygen, within 12 months prior to enrollment as documented in the participant’s medical records.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304951|NCT02927431|Secondary|Time to Absence of Fever|Time from first dose of treatment to time to afebrile status (<=36.6 degree celsius-axilla/temporal or <=37.2 degree celsius- oral, or <=37.7 degree celsius-rectal/core, tympanic) was to be evaluated.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
1304952|NCT02927431|Secondary|Time to Respiratory Response (TTRR)|Time to Respiratory Response was defined as meeting at least one of the following criteria, and maintained for 24 hours: return to pre-morbid oxygen requirement (participants with chronic oxygen use or ventilator support), or return to no requirement of supplemental oxygen, or respiratory rate <=24 per minute (without supplemental oxygen). Kaplan Meier estimates for the median of TTRR for each treatment group was provided. NA indicates data is not available. Due to limited data, no TTRR estimate could be calculated for any of the treatment groups.|Up to 45 Days|IPP Population|||Days||Inter-Quartile Range|Median
1304953|NCT02927431|Primary|Time to Clinical Response (TTCR)|The clinical response was defined as Hospital discharge due to clinical improvement OR normalization of temperature; and oxygen saturation; and respiratory status/heart rate/systolic blood pressure (normalization of 2 out of these 3 parameters). The clinical response based on vital signs/ventilation status required 24-hour confirmation. Considering 2-hour assessment window, the response confirmation period was 22 hours. Kaplan Meier estimates for the median of TTCR was provided. One participant had vital sign resolution at Baseline and was counted as having a clinical response but was not included in the Kaplan Meier Estimates. Influenza Positive Population (IPP) Population comprised of all participants in the Intent to Treat Exposed (ITT-E) Population with influenza infection (positive influenza Polymerase Chain Reaction [PCR] or culture at any time point) confirmed by central lab testing. Only those participants with data available at the indicated time point were analyzed.|Up to 45 Days|IPP Population|||Days||Inter-Quartile Range|Median
1304954|NCT02926573|Secondary|Mean Pain With Swallowing Score as Measured by VAS|"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain"|Baseline through post operative day 3||||mm||Standard Deviation|Mean
1304955|NCT02926573|Secondary|Mean Pain With Coughing Score as Measured by VAS|"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain"|Baseline through post operative day 3||||mm||Standard Deviation|Mean
1304956|NCT02926573|Secondary|Mean Pain With Resting Score as Measured by VAS|"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain"|Baseline through post operative day 3||||mm||Standard Deviation|Mean
1304957|NCT02926573|Secondary|Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control|-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.|Once on post-op day 2 or day of discharge, whichever comes first||||Participants|||Count of Participants
1304958|NCT02926573|Secondary|Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain|-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.|Once on post-op day 2 or day of discharge, whichever comes first||||Participants|||Count of Participants
1304959|NCT02926573|Secondary|Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled|-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.|Once on post-op day 2 or day of discharge, whichever comes first|The participants who did not answer this question on the survey were not evaluable for this outcome measure.|||Participants|||Count of Participants
1304960|NCT02926573|Primary|Change in Daily Narcotic Consumption|Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption.|Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.||||mg/hour||Full Range|Median
1304961|NCT02924350|Secondary|Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10gram (g) and raised in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses were recorded as the tactile threshold. Higher tactile threshold means less sensitive tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3|ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is from ITT population evaluated at specific time points for each treatment arms respectively.|||g||Standard Deviation|Mean
1304982|NCT02922868|Secondary|Number of Cystoscopes With Positive Bioburden Post-procedure.|Immediately after completion of each cystoscopy procedure, the bioburden on the cystoscopes will be evaluated. The flexible cystoscope sheath was removed for bioburden assessment. For each cystoscope, whether sheathed or standard, two locations were assessed – the control body and the shaft. Cultures were obtained wiping the entire surface with sterile saline pledgets. The sample pledgets were placed in 1 ml sterile saline and shaken for 30 seconds. Ten drops of 0.02 ml aliquots from the sample were spotted on two 5% blood agar plates and incubated at 35°C in CO2.|Immediately after cystoscopy.||||bioburdens|cystoscope locations||Number
1305028|NCT02917642|Secondary|Endotoxin Levels|Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay|Through study completion, an average of 2 years||||EU/mL||Full Range|Median
1304962|NCT02924350|Secondary|Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0|ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline(post treatment) assessment of efficacy. Number of participants analyzed is the ITT population evaluated at specific time points for each treatment arms respectively.|||score on a scale||Standard Deviation|Mean
1304963|NCT02924350|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 3|Intent to treat (ITT) population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is from ITT population evaluated at specific time points for each treatment arms respectively.|||score on a scale||Standard Deviation|Mean
1304964|NCT02923245|Other Pre-specified|Inter-rater Agreement|Agreement between the POCUS sonographer and the blinded reviewer|at close of study|304 images were available for assessment of inter-rater reliability|||weighted kappa||95% Confidence Interval|Number
1304965|NCT02923245|Other Pre-specified|Disposition From ED||day of enrollment||||Participants|||Count of Participants
1304966|NCT02923245|Other Pre-specified|TAPUS Result||day of enrollment||||Participants|||Count of Participants
1304967|NCT02923245|Other Pre-specified|Total IV Fluids Given Prior to TAPUS||day of enrollment||||ml/Kg||Standard Deviation|Mean
1304968|NCT02923245|Other Pre-specified|Number of Participants Receiving IV Narcotics in the Emergency Department||day of enrollment||||Participants|||Count of Participants
1304969|NCT02923245|Secondary|Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt||on same day as study enrollment||||Participants|||Count of Participants
1304970|NCT02923245|Primary|Median Fill-To-Done (FTD) Time|Median time from enrollment to successful completion of TAPUS|on same day as study enrollment||||minutes||Inter-Quartile Range|Median
1304971|NCT02922985|Secondary|Pain Scores at 3, 6, and 12 Months After Study Interventions|Patients called at 3, 6 and 12 months after completion of initial enrollment to assess their reported pain scores.|3, 6 and 12 months after initial study enrollments||2018-07-31|07/2018||||
1304972|NCT02922985|Secondary|Hospital Length of Stay||From time of hospital admission to time of discharge home up to 100 days|||||||
1304973|NCT02922985|Secondary|Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.||7 days post delivery||||Tablets||Inter-Quartile Range|Median
1304974|NCT02922985|Secondary|Pain Score at 6-12, 24 and 48 Hours Post Operatively||6-12 hours, 24 hours and 48 hours post operatively|||||||
1304975|NCT02922985|Secondary|Time to First Administration of Opioid Pain Medication Post Operatively||48 hours post cesarean delivery||||hours||Inter-Quartile Range|Median
1304976|NCT02922985|Primary|Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)|Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents|48 hours post cesarean delivery||||morphine milligram equivalents||Inter-Quartile Range|Median
1304977|NCT02922868|Secondary|Number of Procedures Per Day Per Scope.|Number of procedures per day per scope. On a daily basis urology outpatient clinic performs an average of 5 cystoscopies.|Per day.||||Number of procedures per day per scope||Standard Deviation|Mean
1304978|NCT02922868|Secondary|Total Cost of Cystoscopy Reprocessing|The health economics of reprocessing will be evaluated by associating personnel hourly costs with cystoscope reprocessing time segments. The total cost was averaged between pre-cleaning, cleaning, disinfection, rinsing, and drying for the 30 cystoscopes in each group for a duration of 6 months.|6 months||||Dollars|||Number
1304979|NCT02922868|Secondary|Staff Assessment of Cystoscope Reprocessing.|At the end of each day while the study is in progress, 6 members of the medical staff directly involved with the reprocessing of cystoscopes will evaluate the ease of reprocessing based on a 5-point Likert scale for the following parameters: ease of Insertion, ease of manipulation, optical quality, overall ease of use. The score range is 0 to 5. Higher score denotes better outcomes. A single value was derived per staff member and summarized for the group as a whole during 6 months.|At the end of day of each procedure during 6 months||||units on a scale||Standard Error|Mean
1304980|NCT02922868|Secondary|Subject Assessment of Procedure.|After undergoing cystoscopy, patients will be asked to complete Visual Analog Scales (VAS) instruments to determine their level of pain experienced during cystoscopy as well as their perception of discomfort with the procedure. The score range is 0 to 100. Higher scores denotes worse outcomes.|Approximately 2 min after the end of procedure.||||units on a scale||Standard Error|Mean
1304981|NCT02922868|Secondary|Total Time to Reprocess a Cystoscope|The total time required for a cystoscope to be reprocessed so that it is available for re-use in a subsequent procedure will be measured.|Beginning from the time a cystoscope is withdrawn from the urethral meatus at the end of a procedure until the completion of reprocessing, approximately 3,869 seconds||||seconds||Standard Error|Mean
1305007|NCT02920957|Primary|Deposit Grading|Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
1304983|NCT02922868|Primary|Number of Participants Who Had Post-Procedure Bacteriuria|The primary endpoint will be the change in bacteriuria pre- and post-procedure between EndoSheath CST-5000 cystoscope and standard (non-sheathed) Olympus Visera Elite OTV-S190 cystoscope during the course of routine clinical use in a urology clinic. The pre-procedure measurement of bacteriuria will occur on the day of the procedure. The post-procedure measurement of bacteriuria will occur approximately two weeks (10-14 days) post-procedure. This will be assessed by urine culture exams.|10-14 Days Post Procedure||||Participants|||Count of Participants
1304984|NCT02921425|Secondary|Change in Patient Activation|A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation|baseline, 3 months||||units on a scale||Standard Deviation|Mean
1304985|NCT02921425|Secondary|Change in Intent to Adhere to Diet|A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet|baseline, 3 months||||units on a scale||Standard Deviation|Mean
1304986|NCT02921425|Secondary|Change in Intent to Perform Physical Activity|A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity|baseline, 3 months||||units on a scale||Standard Deviation|Mean
1304987|NCT02921425|Secondary|Change From Baseline Diet Self-efficacy|a single 7-point item questionnaire (confidence in one's ability to adhere to a healthy diet). Scale range: 1 - 7. Higher numbers indicate less self-efficacy.|baseline, 3 months||||units on a scale||Standard Deviation|Mean
1304988|NCT02921425|Secondary|Change From Baseline Physical Activity Self-efficacy|"an 18-item exercise self-efficacy questionnaire (confidence in one's ability to exercise) exercises); scale range: 0 - 100.~Higher scores indicate increased self-efficacy."|baseline, 3 months||||units on a scale||Standard Deviation|Mean
1304989|NCT02921425|Primary|Systolic and Diastolic Blood Pressure||baseline, 3 months||||mmHg||Standard Deviation|Mean
1304990|NCT02921425|Primary|Change From Baseline Dietary Intake|24-hour dietary recall; the Nutrition Data System for Research used to compute kcal|baseline, 3 months||||kcal||Standard Deviation|Mean
1304991|NCT02921425|Primary|Change From Baseline Energy Expenditure|measured in kcal using an accelerometer|baseline, 3 months||||kcal||Standard Deviation|Mean
1304992|NCT02921425|Primary|Change From Baseline Abdominal Circumference|measured in inches|baseline, 3 months||||inches||Standard Deviation|Mean
1304993|NCT02921425|Primary|Body Mass Index|Measured in kg/m^2|baseline, 3 months||||kg/m^2||Standard Deviation|Mean
1304994|NCT02921425|Primary|Change From Baseline Weight|measured in lbs.|Baseline, 3 months||||lbs.||Standard Deviation|Mean
1304995|NCT02921412|Primary|Fit Acceptability|Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||units on a scale||Standard Deviation|Mean
1304996|NCT02921412|Primary|Post-blink Movement|Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||units on a scale||Standard Deviation|Mean
1304997|NCT02921412|Primary|Corneal Coverage|Corneal coverage will be assessed (yes/no)|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||Participants|||Count of Participants
1304998|NCT02921412|Primary|Centration|Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||Participants|||Count of Participants
1304999|NCT02921412|Primary|Visual Acuity|High contrast distance visual acuity is measured by LogMAR.|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||logMAR||Standard Deviation|Mean
1305000|NCT02921386|Primary|Time Weighted Average Total Testosterone Concentration (Cavg-am)|The time weighted average of total testosterone concentration will be assessed for each dosing interval.|12 hours||||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1305001|NCT02921386|Primary|Area Under the Curve (AUC-am)|The 12 hours following morning dose area under the curve (AUC) will assessed for each sequence of breakfasts with varying fat content.|0, 1, 2, 3, 4, 6, 8, 12 hours post-dose||||ng*hr/dL||Geometric Coefficient of Variation|Geometric Mean
1305002|NCT02921386|Primary|Time of Peak Concentration (Tmax-am)|The time of peak concentration (Tmax-am) will be assessed within each relevant dosing interval.|12 hours||||hours||Full Range|Median
1305003|NCT02921386|Primary|Cmax-am for Oral TU Across Breakfast With Varying Fat Content|Peak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content.|0, 1, 2, 3, 4, 6, 8, 12 hours post-dose||||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1305004|NCT02921295|Secondary|Gait Symmetry Index|Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.|2 times throughout study completion (every 1 hour during the 2 hour protocol)||||ratio||Standard Deviation|Mean
1305005|NCT02921295|Secondary|Timed up and go Test Time|The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.|6 times throughout study completion (3 every 1 hour during the 2 hour protocol)||||s||Standard Deviation|Mean
1305006|NCT02921295|Primary|Average Speed for 10 Meter Walk Test|The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.|2 times throughout study completion (every 1 hour during the 2 hour protocol)||||m/s|||Number
1305009|NCT02920957|Primary|Tightness on Push up|Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
1305010|NCT02920957|Primary|Lens Lag at Primary Gaze|Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||millimeters||Standard Deviation|Mean
1305011|NCT02920957|Primary|Post-blink Movement|Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
1305012|NCT02920957|Primary|Lens Centration|Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||participants|||Number
1305013|NCT02920957|Primary|Corneal Coverage|Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||participants|||Number
1305014|NCT02920957|Primary|Overall Lens Fit Acceptance|Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
1305015|NCT02920749|Secondary|Costs of Anaesthesia|total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros|1 hour||||euros|total cost of anaesthesia|Standard Deviation|Mean
1305016|NCT02920749|Primary|Drug Consumption|drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams|at induction one dose and during anaesthesia mg/1 hour||||mg||Standard Deviation|Mean
1305017|NCT02919657|Primary|Weekly Blood Draws to Measure Blood Protein Levels|"Each week the 20 participants will have blood drawn to measure their blood protein levels.~Each participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable.~10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6.~10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6.~These measurements will read in g/dl"|6 weeks per intervention||||grams per deciliter||Standard Deviation|Mean
1305018|NCT02918773|Secondary|Clinician Acceptability of the Smartphone Otoscopic Device|Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing.|Month 6|Only participating clinicians who were randomized to use the smartphone otoscope were administered a survey at the end of the 6-month intervention.|||Participants|||Count of Participants
1305019|NCT02918773|Secondary|Number of Diagnoses of Otitis Externa|The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician.|Month 6||||Emergency department encounters|Clinic encounters||Number
1305020|NCT02918773|Secondary|Number of Diagnoses of Acute Otitis Media (AOM)|The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician.|Month 6||||Emergency department encounters|Clinic encounters||Number
1305021|NCT02918773|Primary|Number of Antibiotic Prescriptions|The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician.|Month 6|This analysis includes emergency department encounters with children by a participating clinician where AOM was diagnosed.|||Emergency department encounters|Number of encounters||Number
1305022|NCT02918630|Primary|Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back|Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.|week 5||||number of cigarettes per day||Standard Deviation|Mean
1305023|NCT02918630|Secondary|Feasibility as Assessed by Percent of Participants Who Completed the Study||week 5||||percent of participants|||Number
1305024|NCT02918630|Primary|Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back|Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.|Baseline||||number of cigarettes per day||Standard Deviation|Mean
1305025|NCT02918630|Primary|Change in Smoking as Assessed by Urinary Cotinine Levels||Baseline, Week 5||||ng/mL||Standard Deviation|Mean
1305026|NCT02918630|Primary|Change in Smoking as Assessed by Breath Carbon Monoxide Levels||Baseline, Week 5||||parts per million (ppm)||Standard Deviation|Mean
1305027|NCT02918396|Primary|Recurrence of Atrial Fibrillation (AF) > 30 Seconds|Primary outcome is defined as symptomatic or asymptomatic AF of at least 30 seconds duration that is documented by an ECG or mobile rhythm monitoring device (AliveCor), occurring after the 3-month blanking period following catheter ablation and up to 12 months.|Following the 90 day blanking period up to 12 months post-index pulmonary vein isolation||||Participants|||Count of Participants
1305030|NCT02915978|Secondary|Participant Global Evaluation of Study Drug|Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
1305031|NCT02915978|Secondary|Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours||Over 0 to 24 hours; Over 0 to 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
1305032|NCT02915978|Secondary|Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)||Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
1305033|NCT02915978|Secondary|Number of Participants Using Rescue Medication||Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
1305034|NCT02915978|Secondary|Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)|Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)|Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
1305035|NCT02915978|Secondary|Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)|Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)|Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
1305036|NCT02915978|Secondary|Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)||Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
1305037|NCT02915978|Secondary|Peak Pain Relief From Time 0 (First Dose of Study Medication)|The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.|Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
1305038|NCT02915978|Secondary|Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)|Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.|2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia|All randomized participants from the Intent-to-Treat (ITT) population. The number analyzed differs in the later time points for the Fentanyl groups because some participants withdrew over the course of the study.|||Participants|||Count of Participants
1305039|NCT02915978|Secondary|Time to Onset of Analgesia|Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)|Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
1305040|NCT02915978|Secondary|Total Pain Relief (TOTPAR) After Time 0|TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.|Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48)|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1305041|NCT02915978|Secondary|NRS SPID After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each timepoint], and negative numbers indicate an increase in pain [minimum(min)=-10 at each timepoint]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.|Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24)|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1305042|NCT02915978|Secondary|NRS Pain Intensity Score at Each Scheduled Time Point After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|Baseline, 1, 16, and 24 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1305265|NCT02862106|Secondary|The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit||week95,108,120,144|intention to treat population|||percentage of participants|||Number
1305043|NCT02915978|Secondary|NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled time point relative to Baseline (PID=pain intensity at baseline – pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. NRS PID is reported as the least squares mean difference.|Baseline, 1, 16, and 24 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1305044|NCT02915978|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Over 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1305045|NCT02915302|Secondary|Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. SCR was defined as percentage of participants with either a pre-vaccination titer <10 (1/dil) and a post-final vaccination titer >=40 (1/dil), or a pre-vaccination titer >=10 (1/dil) and at least a four-fold increase in post-final vaccination titer.|28 days post-final vaccination|Analysis was performed using the PP analysis set. Here, ‘Number Analyzed’ = those participants with available data for specified categories.|||percentage of participants||95% Confidence Interval|Number
1305046|NCT02915302|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.|28 days post-final vaccination|Analysis was performed using Per-protocol (PP) analysis set which included participants who received at least 1 dose of study vaccine and had a valid post-vaccination serologic result for at least 1 strain without any protocol deviations. Here, ‘Number Analyzed’ = those participants with available data for specified categories.|||Titers (1/dilutions [dil])||95% Confidence Interval|Geometric Mean
1305047|NCT02915302|Primary|Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine|Fever rate was defined as percentage of participants with fever (temperature >=100.4 degrees Fahrenheit [38.0 degrees Celsius]) following vaccination with Fluzone Quadrivalent vaccine.|Within 7 days after any vaccination|Analysis was performed using the safety analysis set. Here, ‘Number of participants analyzed’ = those participants with available data for this endpoint.|||percentage of participants||95% Confidence Interval|Number
1305048|NCT02914236|Other Pre-specified|Subject Satisfaction|"Study-specific survey to assess patient satisfaction with the discomfort of the procedure and recovery period, as well as their perceived results. The survey included 5 questions related to tolerability of the procedure, ease of recovery, change in breathing, satisfaction with treatment, and willingness to recommend treatment. Each question was scored on a 10-point scale, with 1 indicating the most negative response to the question (e.g., very bad, much worse, or very dissatisfied) and 10 indicating the most favorable rating (e.g., hardly noticeable, much better, or very satisfied). Each question was individually scored and reported."|26 weeks|Does not include subject lost-to-follow-up prior to 26-week follow-up visit|||units on a scale||Standard Deviation|Mean
1305049|NCT02914236|Other Pre-specified|Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale|"Procedure-related pain as reported by the subject using a 100mm Visual Analog Scale (VAS), immediately post-procedure and at the 4-week follow-up visit. Higher scores indicate more severe pain.~The Pain VAS is presented to the subject as a 100mm line anchored on each end by verbal descriptors: 0 = no pain and 100 = worse pain imaginable. The distance between 0 and the vertical mark made by the subject is measured and the result is expressed in millimeters."|Immediately after study procedure, 4-weeks|All treated subjects were asked to rate the pain level in each of their nostrils immediately following the treatment procedure and at the 4-week follow-up visit.|||units on a scale|Nostrils|Standard Deviation|Mean
1305050|NCT02914236|Secondary|Percentage of Participants With Treatment-Related Adverse Events (Safety)|Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.|Baseline through 26 weeks|All treated subjects|||percentage of subjects having an event|||Number
1305051|NCT02914236|Secondary|NOSE Responder Rate|Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.|Baseline, 26 weeks|Does not include subject lost-to-follow-up prior to 26-week follow-up|||percentage of treated subjects||95% Confidence Interval|Number
1305052|NCT02914236|Primary|Improvement in NOSE Score|"Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive value.~The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity."|Baseline, 26 weeks|Does not include subject lost-to-follow-up prior to the 26-week follow-up visit|||units on a scale||Standard Deviation|Mean
1305159|NCT02877732|Secondary|Compare ANAM-SRT Test and EYE-SYNC Score|The Automated Neuropsychological Assessment Metrics-Simple Reaction Time (ANAM-SRT) evaluation and EYE-SYNC score will be compared.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
1305053|NCT02912650|Other Pre-specified|Participant's Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.|0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305054|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Meaningful Relief|"Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy."|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
1305055|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
1305056|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Treatment Failure|Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.|1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
1305057|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose|SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.|0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305058|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose|TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours. TOTPAR total score range: 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305059|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose|Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12 and -3 (worst score) to 9 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).|0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305060|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst) to 10 (best).|0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1310349|NCT02570425|Secondary|Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants||4 weeks||||errors|||Number
1305061|NCT02912650|Other Pre-specified|Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)|PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305062|NCT02912650|Other Pre-specified|Pain Intensity Difference on 4-Point Categorical Scale (PID4)|PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305063|NCT02912650|Other Pre-specified|Pain Intensity Difference on 11-Point Numerical Scale (PID11)|PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305064|NCT02912650|Other Pre-specified|Pain Relief Rating (PRR) Score|"Participants answered a question: “how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief."|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305065|NCT02912650|Other Pre-specified|Time to Confirmed Onset of First Perceptible Relief|Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.|0 to 12 hours post-dose|"FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (first perceptiblre relief)."|||minutes||95% Confidence Interval|Median
1305066|NCT02912650|Secondary|Time to Onset of Meaningful Pain Relief|"Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy."|0 to 12 hours post-dose|"FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (meaningful pain relief)."|||minutes||95% Confidence Interval|Median
1305067|NCT02912650|Secondary|Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours|Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.|6 hours, 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
1305068|NCT02912650|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.|0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1305069|NCT02912650|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose|TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0 to 8 hours, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305093|NCT02901951|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after the challenge dose|Analysis was performed on the TVC which included all subjects who received the challenge dose.|||Participants|||Count of Participants
1305070|NCT02912650|Secondary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305071|NCT02912650|Primary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|0 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1305072|NCT02911857|Primary|Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths|Participants were monitored for safety throughout the study.|Participants were followed for the duration until approval, an expected average of 3 months.|Safety set: The safety set included all participants who were treated in this extension study.|||Participants|||Count of Participants
1305073|NCT02910362|Primary|Determine Comparative IOP Stability Between Abbott and Alcon Phacoemulsification Equipment.||intraoperative||||mmHg|eyes|Standard Deviation|Mean
1305074|NCT02908269|Secondary|Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years)|Anti-influenza antibodies were measured using HAI assay for 3 strains: H1N1, H3N2, Victoria lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Participants|||Count of Participants
1305075|NCT02908269|Secondary|Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years)|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Participants|||Count of Participants
1305076|NCT02908269|Secondary|Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years)|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Participants|||Count of Participants
1305077|NCT02908269|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years)|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Titers (1/dilutions)||95% Confidence Interval|Median
1305078|NCT02908269|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years)|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1305079|NCT02908269|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed using the Per-protocol Analysis Set (PPAS), which included all participants who received study vaccine and had a valid post-vaccination serology result for at least 1 strain.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1305080|NCT02908269|Primary|Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years)|Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema & swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.|Within 7 days after any vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
1305094|NCT02901951|Secondary|Number of Subjects With Any Solicited General AEs|Assessed solicited general symptoms were fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius [°C]) , gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain) and headache. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the TVC which included all subjects who received the challenge dose.|||Participants|||Count of Participants
1305160|NCT02877732|Secondary|Compare Sport Concussion Assessment Tool (SCAT-3) Test and EYE-SYNC Score|The SCAT-3 result and EYE-SYNC score will be compared.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
1305081|NCT02908269|Primary|Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age)|Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema & swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.|Within 7 days after any vaccination|Analysis was performed using the Safety Analysis Set, which included all participants who received the study vaccine. Number of participants analyzed corresponds to participants with available data for the listed solicited reaction.|||Participants|||Count of Participants
1305082|NCT02907892|Primary|Composite Wound Complication|Occurence of at least one of the following: wound seroma, wound hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure to fix|Within 8 weeks following cesarean section|Participants with follow-up data (at least one postpartum visit within 8 weeks of delivery)|||Participants|||Count of Participants
1305083|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 16 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 16 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
1305084|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 4 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 4 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1305085|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 2 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 2 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
1305086|NCT02905825|Secondary|Percentage of Agreement|Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection|1 week||||percentage of pos. or neg. agreeement||95% Confidence Interval|Number
1305087|NCT02905825|Secondary|Percentage of Agreement|Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection|1 week|Although 42 subjects completed the protocol, there was a device malfunction in this arm, therefore only 41 performed the continuous test.|||percentage of pos. or neg. agreeement||95% Confidence Interval|Number
1305088|NCT02905825|Primary|Number of Participants With Reported Adverse Events|Number of participants with reported adverse events after performing urea breath test|24 hours||||Participants|||Count of Participants
1305089|NCT02903238|Secondary|Overall Brain Neocortical Gray Matter Volume||2 weeks|Data were not collected and the Outcome will never be analyzed||||||
1305090|NCT02903238|Secondary|WOMAC Pain Index|Osteoarthritis (OA) specific pain and quality of life index (the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC). The WOMAC score is from 0 to 96 where 0 represent no pain and quality of life impairment due to OA and 96 represent the worst pain and quality of life impairment due to OA. The outcome is reported as the percent change from baseline to end of treatment (2 weeks).|2 weeks||||Percent Change in WOMAC score||Standard Deviation|Mean
1305091|NCT02903238|Primary|Brain Regional Gray Matter Density|"Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders.~GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region."|2 weeks||||Gray Matter Density: 0 to 1||Standard Deviation|Mean
1305092|NCT02901951|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed included any untoward medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Day 30)|Analysis was performed on the TVC which included all subjects who received the challenge dose.|||Participants|||Count of Participants
1305095|NCT02901951|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local symptoms were injection site pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects who received the challenge dose.|||Participants|||Count of Participants
1305096|NCT02901951|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.|At the pre-challenge dose time-point (Day 0), at 7 days post-challenge dose time-point (Day 7) and at 30 days post-challenge dose time-point (Day 30)|Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1305097|NCT02901951|Secondary|Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values|Percentage of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.|At the pre-challenge dose time-point (Day 0), at 7 days post-challenge time-point (Day 7) and at 30 days post-challenge time-point (Day 30)|Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||Percentage of subjects||95% Confidence Interval|Number
1305098|NCT02901951|Primary|Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose|Anamnestic response to the challenge dose was defined as: At least (i.e. ≥ 4-fold rise in one month post-vaccination anti-HBs antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 mIU/mL at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point.|30 days after the challenge dose (Day 30)|Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||Percentage of subjects||95% Confidence Interval|Number
1305099|NCT02901951|Primary|Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose|Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to [≥]) 4-fold rise in one month post-vaccination anti-hepatitis B surface antigen (anti-HBs) antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 milli International Unit/Milliliter (mIU/mL) at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point.|7 days after the challenge dose (Day 7)|Analysis was performed on the According-to-protocol (ATP) cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||Percentage of subjects||95% Confidence Interval|Number
1305100|NCT02901054|Primary|CSF to Plasma Concentration Ratio|CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample|0-180 min from the beginning of infusion||||Ratio||Standard Deviation|Mean
1305101|NCT02898116|Secondary|Number of Subjects With Immune-related Tumor Response at the Last Assessment|Immune-related tumor response was evaluated by computed tomography at Baseline, every 2 cycles, and at the end of the study. Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al. Clin Cancer Res 2009;15:7412-20) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.|up to 3 months|All enrolled subjects|||Participants|||Count of Participants
1305102|NCT02898116|Secondary|Number of Subjects With Best Overall Tumor Response at the Last Assessment|Tumor response was evaluated using computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) at Baseline, every 2 cycles, and at the end of the study. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|up to 3 months|All enrolled subjects|||Participants|||Count of Participants
1305103|NCT02898116|Primary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the end of the study period. Dose-limiting toxicity (DLT) during the Run-in Period was defined as ≥ Grade 2 rash or other toxicity requiring discontinuation of ensartinib dosing.|up to 3 months|All enrolled subjects|||participants|||Number
1305104|NCT02895347|Primary|Amount of Time to Achieve Proficiency|time, measured in minutes, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator.|assessed after the orientation and prior to the three week date for the final suturing assessment||||minutes||Full Range|Mean
1305105|NCT02895347|Primary|Amount Time to Suture|time, measured in minutes, it took each participant to perform the suturing activity|Three weeks after orientation||||minutes||Standard Deviation|Mean
1305266|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBsAg and HBsAb.||week95,108,120,144|intent-to-treat population|||percentage of participants|||Number
1305106|NCT02895347|Primary|Global Evaluative Assessment of Robotic Skills (GEARS) Scale|GEARS is a validated assessment tool for grading overall technical proficiency for robotic surgery. The overall proficiency score is a composite score of five different measures: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Each of these subscale scores are graded 1-5, with 1 being poor and 5 being excellent. The total score is the summation of the scores from each of the five subscales and ranges from 5 to 25.|Three weeks after orientation||||units on a scale||Standard Deviation|Mean
1305107|NCT02891863|Primary|Conversion Efficacy of Low Energy VT Therapies|Effectiveness of LEVER Acute Study System low energy therapies to convert MVTs will be collected and tracked as an aggregate success rate (%) on a per-attempt basis for each therapy tested.|Acute - eg within 5 seconds of test therapy delivery|6 of 9 subjects had at least one inducible VT, a total of 14 attempts to convert VT with multiple pulses were delivered and none converted the VT in any subject.|||percentage of VF conversion success|Attempts at VF Conversion||Number
1305108|NCT02891863|Primary|System and Procedure Related Adverse Events|All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.|7 days post-procedure||||participants|||Number
1305109|NCT02890381|Secondary|Number of Participants With B Cell Responses to Vaccine|A B cell response to vaccine is indicated by a greater than or equal to 4-fold change in serum antibody titers to RSV F glycoprotein between the pre- and post-inoculation time points, and between pre- and post-RSV surveillance time points.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|One placebo recipient had missing data for the Day 56 and the pre-RSV surveillance time points. All other participants were included.|||Participants|||Count of Participants
1305110|NCT02890381|Secondary|Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the Subsequent RSV Season.|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included.|||log 2 titers||Inter-Quartile Range|Median
1305111|NCT02890381|Secondary|Number of Participants Who Had Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season|The number of participants who had symptomatic, medically attended respiratory and febrile illness among those who had RSV detected in nasal washes or >=4 fold rise in serum antibodies during the subsequent RSV season were presented. A participant was only counted once in each solicited AE category, and that was in the line corresponding to the highest grade adverse event they had in that category.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|Only participants who had RSV detected in nasal washes or >=4 fold rise in serum antibodies during the subsequent RSV season were included.|||Participants|||Count of Participants
1305112|NCT02890381|Primary|Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Immunogenicity was assessed at approximately 2 months post-inoculation (Study Day 56).|Measured at Day 56|One placebo recipient had missing data at Day 56. All other participants were included.|||log 2 titers||Inter-Quartile Range|Median
1305113|NCT02890381|Primary|Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer|Immunogenicity was assessed pre-inoculation, and at approximately 2 months post-inoculation (Study Day 56). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre and post time points.|Measured at Day 0 and Day 56|One placebo recipient had missing data at the Day 56 evaluation. All other participants were included.|||Participants|||Count of Participants
1305114|NCT02890381|Primary|Duration of Virus Shedding in Nasal Washes|Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.|Only participants who met the definition of infection were included.|||days||Inter-Quartile Range|Median
1305115|NCT02890381|Primary|Peak Titer of Vaccine Virus Shed|This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28|Only participants who met the definition of infection with vaccine virus were included.|||log 10 Plaque Forming Units (PFU)/mL||Inter-Quartile Range|Median
1305116|NCT02890381|Primary|Number of Participants Infected With RSV Vaccine|Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes) or 2) greater than or equal to 4-fold rise in serum RSV-neutralizing antibody titer between Study Days 0 and 56.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies|All participants were included.|||Participants|||Count of Participants
1305117|NCT02890381|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:~Results in death during the period of protocol-defined surveillance~Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe~Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting~Results in a persistent or significant disability/incapacity~Is a congenital anomaly or birth defect~Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Measured from Day 0 through Day 56|All participants were included.|||Participants|||Count of Participants
1305158|NCT02877732|Secondary|Compare DEM Test and EYE-SYNC Score|The Developmental Eye Movement (DEM) assessment and EYE-SYNC score will be compared.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
1305118|NCT02890381|Primary|Number of Participants With Unsolicited AEs by Grade|Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).|Measured from Day 0 through Day 28|All participants were included.|||Participants|||Count of Participants
1305119|NCT02890381|Primary|Number of Participants With Solicited Adverse Events (AEs) by Grade|Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 3 and Table 4 in the protocol document.|Measured from Day 0 through Day 28|All study participants were included.|||Participants|||Count of Participants
1305120|NCT02890303|Primary|Complete Capsulotomy|"A successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually.~The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases)."|During surgery||||participants|||Number
1305121|NCT02889289|Other Pre-specified|Time in Therapeutic Heart Rate Range (TTR)|TTR is the amount of time the Veteran spends within a target heart range of moderate to vigorous exercise prescribed as greater than 40% heart rate reserve.|(Intervention) 2 times per week for 8 weeks||||Minutes||Standard Deviation|Mean
1305122|NCT02889289|Other Pre-specified|Total Activity Time (TAT)|TAT is a measure of the total time that the Veteran will be participating in mini-game challenges during the 60 minute intervention session.|(Intervention) 2 times per week for 8 weeks||||Minutes||Standard Deviation|Mean
1305123|NCT02889289|Secondary|Heart Rate at Beginning of Mini-game|Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.|(Intervention) 2 times per week for 8 weeks||||Heart beats per minute||Standard Deviation|Mean
1305124|NCT02889289|Secondary|Heart Rate at End of Mini-game|Heart rated recorded using heart monitor and chest strap at the end of each mini-game.|(Intervention) 2 times per week for 8 weeks||||Heart beats per minute||Standard Deviation|Mean
1305125|NCT02889289|Secondary|Limits of Stability (LOS) - Directional Control|The LOS is performed on the NeuroCom Balance Manager. The LOS test is a goal-directed weight shifting task. The LOS-directional control measures the accuracy of an individual's movement of center of gravity during the task compared to a straight line. This is reported as a percentage without units.|(Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5||||percentage of accuracy||Standard Deviation|Median
1305126|NCT02889289|Primary|Dynamic Gait Index (DGI)|The DGI is a common clinical measure used to evaluate dynamic balance and coordination during a person’s daily activities. This test was developed by Shumway-Cook and features 8-items which assess a person’s ability to walk while turning their head, changing speed, and navigating obstacles. The DGI is scored from 0 to 24 where higher scores indicate higher dynamic balance function.|Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5||||units on a scale||Standard Deviation|Median
1305127|NCT02886715|Primary|Change in Non-inflammatory Lesion Counts|Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts|Week 12|mITT for superiority versus placebo, PP for equivalence versus Reference|||percent change||Standard Error|Least Squares Mean
1305128|NCT02886715|Secondary|Clinical Response of Success|The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment|Week 12|mITT|||percentage of participants|||Number
1305129|NCT02886715|Primary|Change in Inflammatory Lesion Counts|Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts|Week 12|mITT for superiority versus placebo, PP for equivalence versus Reference|||percent change||Standard Error|Least Squares Mean
1305130|NCT02886702|Secondary|Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI|Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).|Week 12|mITT|||Percentage of Participants|||Number
1305131|NCT02886702|Secondary|Disease Severity None or Minimal on IGA|Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).|Week 12|mITT|||Percentage of Participants|||Number
1305132|NCT02886702|Primary|Treatment Success Assessed by IGA|"Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the Investigator’s Global Assessment of Disease Severity (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study)."|Week 12|mITT for superiority versus placebo, PP for equivalence versus Reference|||Percentage of Participants|||Number
1305133|NCT02886338|Primary|Assess the Completeness of Capsule Endoscopy|Evaluate the completeness of capsule endoscopic examination. Visualization of the mucosa of esophagus, stomach and duodenum is analyzed separately during and after the capsule endoscopic examination by real time image and capsule video images. We evaluate the percentage of mucosa that can be clearly examined with a 5-point assessment scale (0%, 25%, 50%, 75% and 100% of the visibility of the mucosa of esophagus, stomach, and duodenum)|The outcome measure was performed within 2 weeks after examination|Subjects had completed the magnetic capsule endoscopic examination|||percentage of mucosa visibility||Full Range|Mean
1305134|NCT02884427|Secondary|Difference of Maximum Grip Strength for Females|The difference in maximum grip strength for females is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the women of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.||||Kilograms (Kg)||Standard Deviation|Mean
1305135|NCT02884427|Secondary|Difference of Maximum Grip Strength for Males|The difference in maximum grip strength for males is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the men of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.||||Kilograms (Kg)||Inter-Quartile Range|Median
1305136|NCT02884427|Primary|Difference of Maximum Grip Strength|The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.||||Kilograms (Kg)||Standard Deviation|Mean
1305137|NCT02884089|Secondary|Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol|Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol was evaluated.|Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Iohexol & had evaluable PK data.|||Milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1305138|NCT02884089|Primary|Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin|Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated.|Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.|||Liters per Hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1305139|NCT02884089|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated.|Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1305140|NCT02884089|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Metformin was evaluated.|Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.|||Nanogram*Hour per Milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1305141|NCT02882152|Secondary|Postoperative Bleeding|Postoperative bleeding volume (ml)|baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours||||mL||Standard Deviation|Mean
1305142|NCT02882152|Primary|Analgesic Efficacy|Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).|baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours||||units on a scale||Standard Deviation|Mean
1305143|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3|centre of pressure excursion index = CPEI|From baseline to week 3||||Percentage of Change||Inter-Quartile Range|Median
1305144|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305145|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305146|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305147|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305148|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3||From baseline to week 3||||percentage of body temperature change||Inter-Quartile Range|Median
1305149|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305150|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305151|NCT02881658|Secondary|Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305152|NCT02881658|Secondary|Change of Serum Creatinine Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305153|NCT02881658|Secondary|Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305154|NCT02881658|Secondary|Change of Total Cholesterol Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305155|NCT02881658|Secondary|Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305156|NCT02881658|Secondary|Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
1305157|NCT02881658|Primary|Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3|All 201 subjects were included in the population, but certain blood test result on LDL-C were not available, thus difference in the overall number of participants analyzed and the actual number of participants included to present the mean value.|||mmol/L||Standard Deviation|Mean
1305267|NCT02862106|Secondary|The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144||week95,108,120,144|intention to treat population|||percentage of participants|||Number
1305161|NCT02877732|Primary|Integrity of EYE-SYNC Data|The reliability will be analyzed based on the score obtained from EYE-SYNC.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
1305162|NCT02877732|Primary|Reliability of EYE-SYNC Data|The integrity will be analyzed based on the score obtained from EYE-SYNC device.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
1305163|NCT02877732|Primary|Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event.|The EYE-SYNC test will be performed immediately after an impact, 2 days, 7 days and 14 days post impact. The movement of eye will be tracked using EYE-SYNC. The data will be recorded in a surface tablet connected to EYE-SYNC.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
1305164|NCT02877082|Secondary|Overall Survival|Will be analyzed with Kaplan Meier method and Logrank test.|At 1 year post-transplant|Data were not collected because trial closed early.||||||
1305165|NCT02877082|Secondary|Incidence of Chronic GVHD|Will be summarized as percentage and 95% confidence level will be also constructed.|Up to 2 years post-transplant|Data were not collected because trial closed early.||||||
1305166|NCT02877082|Secondary|Cumulative Incidence of Grade III-IV aGVHD|Will be summarized as percentage and 95% confidence level will be also constructed.|Up to 2 years post-transplant|Data were not collected because trial closed early.||||||
1305167|NCT02877082|Primary|Number of Patients Alive and Free of Severe Acute GVHD Following HLA Matched Related or Unrelated Donor Hematopoietic Peripheral Blood Transplant|Will use patient counts for the number of patients alive and free of severe acute graft versus host disease (GVHD) following human leukocyte antigen (HLA) matched related or unrelated donor hematopoietic peripheral blood transplant.|At 6 months post-transplant||||Participants|||Count of Participants
1305168|NCT02877082|Primary|Total Number of Serious Adverse Events and Adverse Events Related to This Immunosuppressive Regimen|"An adverse event (AE) is defined as any untoward medical experience or change of an existing condition that occurs during or after treatment. All AEs occurring during this study, whether observed by the physician, nurse, or reported by the patient, will be graded per NCI CTCAE version 4.0 and recorded on protocol-specific case report forms. A serious adverse event (SAE) is defined as any expected or unexpected adverse event (AE, generally equivalent to CTCAE grades 3, 4 or 5) that results in any of the following outcomes:~Death~Life-threatening event~In-patient hospitalization (not required as part of the treatment) or prolongation of existing hospitalization~Persistent or significant disability/incapacity~Congenital anomaly/birth defect~Cancer~Overdose"|Up to 6 months post-transplant||||events|||Number
1305169|NCT02876757|Secondary|Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)|"Any CIHI-DAD/SDS ICD 10 code, OR~Any OMRHS code Axis1_dsm4code1-19 or Axis2_dsm4code 1-7 OR~Look for any OHIP record billed by Mainspecialty = “PSYCHIATRY” with a diagnosis of depression OHIP dxcode 311, OR~≥2 GP visits within 2 years AND both with OHIP dxcode 311~i. OHIP dxcode: 311 ii. ICD 10: F32.0, F32.1, F32.2, F32.3, F32.8, F32.9, F33.0, F33.1, F33.2, F33.3, F33.4, F33.8, F34.1 iii. Psychiatry visits defined as any of these OHIP fee codes: A195, A895, A190, A795, A695, A395, A196, A193, A194, A191, A192 iv. OMHRS: 29620-29626, 29630-29636, 31100 (major depressive disorder)"|Through study completition, an average of 18 months.|This population is restricted to those who had no history of depression, thus it is a subgroup of the total study population.|||Participants|||Count of Participants
1305170|NCT02876757|Secondary|Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)|"NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm).~OMHRS: admission with suicide ideation.~i. Self injury attempts: D1A or selfinjury_attempt=3, 4, 5, or 6 ii. Self injury intent: D1B or selfinjury_intent=1 iii. Self injury considered: D1C or selfinjury_cons=3, 4, 5 or 6 iv. Self injury plan: D1DB or suicide_plan=1"|Through study completition, an average of 18 months.||||Participants|||Count of Participants
1305171|NCT02876757|Primary|Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database)|"Ontario Registrar General Death database. Use the COD_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84.~NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event.~OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event.~CIHI-DAD (Consider admission date the date of the event):~i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp=”07”."|Through study completition, an average of 18 months.||||Participants|||Count of Participants
1305172|NCT02874846|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||7 days (day 1/2 to day 8/9)|ITT|||Participants|||Count of Participants
1305173|NCT02874846|Primary|Change in Intraocular Pressure (IOP) Over Nocturnal Time Period|The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9|Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9|ITT|||mmHg||Standard Deviation|Mean
1305174|NCT02873754|Secondary|Number of Quit Smoking Attempts|Participants will self-report the number of quit attempts they've had since baseline.|3 month follow up|These data were only available for 2 participants.|||quit attempts||Standard Deviation|Mean
1305175|NCT02873754|Secondary|Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit|Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date|3 month follow up|Only one participant completed the timeline follow-back procedure at 3 months|||cigarettes|||Number
1305176|NCT02873754|Secondary|Change in the Number of Days in Which Smoked Compared to Pre-quit Use|Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked in 30 days prior to quit.|3 month follow up|These data were only available for one participant.|||days|||Number
1312118|NCT02517021|Secondary|Percentage of Patients With no Emetic Episodes in the Acute Phase||0-24 hours||||Participants|||Count of Participants
1305177|NCT02873754|Secondary|Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.|Participants will be interviewed about the amount of time spent in light, moderate, and hard physical activity during the past 7 days. Total number of days of moderate and hard exercise in last 7 days will be compared to self-reported values at baseline (i.e., # of days of exercise in past 7 days at 3-month follow-up minus # of days of exercise in past 7 days at baseline).|baseline and 3 month follow up|Data are only available for two participants.|||days||Standard Deviation|Mean
1305178|NCT02873754|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking|30-day point prevalence abstinence is defined as no smoking in the prior 30 days.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
1305179|NCT02873754|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
1305180|NCT02873754|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking|30-day point prevalence abstinence is defined as no smoking in the prior 30 days.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
1305181|NCT02873754|Secondary|Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
1305182|NCT02873754|Primary|Number of Participants Whose Prolonged Abstinence is Bio-verified|Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. No participants reported prolonged abstinence, so bioverification wasn't completed.||||||
1305183|NCT02873754|Primary|Number of Participants Who Self-report Prolonged Abstinence From Smoking|Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
1305184|NCT02873754|Primary|Number of Participants Whose Prolonged Abstinence is Bio-verified|Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. Two participants didn't self-report abstinence, so bioverification was not completed.|||Participants|||Count of Participants
1305185|NCT02873754|Primary|Number of Participants Who Self-report Prolonged Abstinence From Smoking|Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
1305186|NCT02873481|Secondary|Recruitment Feasibility|Numbers of women who agreed to participate in the study;|at intervention completion, an average of 20 weeks||||participants|||Number
1305187|NCT02873481|Secondary|Number of Subjects Participating in Focus Group|Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period|at intervention completion, an average of 20 weeks||||Participants|||Count of Participants
1305188|NCT02873481|Secondary|Stress|Perceived Stress Scale (PSS): The Perceived Stress Scale-10 (PSS-10), a widely used, psychometrically sound instrument, will assess the degree to which a participant perceives stress in her life during the past month. The PSS-10 asks respondents to report about feelings such as unpredictability, uncontrollability, and overloading of stress in their lives; scores range from 0-40; higher scores correspond to a higher perceived stress level.|baseline (early pregnancy), end of pregnancy (approx 10 months)||||units on a scale||Standard Deviation|Mean
1305189|NCT02873481|Secondary|Depressive Symptoms|Patient Health Questionnaire-9 (PHQ9): The PHQ-9 includes self-report items regarding depressive symptoms over the past two weeks. Total scores range from 0-27, where 0-4 indicates minimal depression, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, and ≥20 severe depressive symptoms.|baseline (early pregnancy), end of pregnancy (approx 10 months)||||units on a scale||Standard Deviation|Mean
1305190|NCT02873481|Secondary|Salivary Biomarkers (α-amylase)|"salivary biomaker measure. This is an exploratory measure related to acute stress, yet it does not currently have known clinical associations with certain numeric levels of this measure (i.e., there is no identified high or low level of alpha-amylase). Only collected in the intervention group."|baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)||||U/mL||Standard Deviation|Mean
1305206|NCT02869451|Secondary|Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group)|Participants will self-report number of days smoked in the past 30 days and this will be compared (for the entire group) to self-reported number of days smoked in 30 days prior to quit. The proportion will be calculated by totaling baseline days used and pretreatment days used, and then dividing baseline days used by pretreatment days used.|30 days prior to quit date, 6 month follow up||||percentage of pre-quit use|||Number
1351301|NCT01780922|Primary|Interleukin-1alpha (IL-1a) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1305191|NCT02873481|Secondary|Self-efficacy for Physical Activity|Physical Activity Self-Efficacy Scale (PASES): The Physical Activity Self-Efficacy Scale (PASES) is an 8 question scale which contains items about SM of physical activities and social support regarding PA. This psychometrically sound scale was selected because of its specific focus on SM of PA. Originally designed for adolescents, the wording has been slightly adapted for an adult sample. A higher score indicates higher levels of self-efficacy. Lowest possible score is 8; highest possible score is 40. Only participants in the intervention arm receive this particular instrument.|baseline (early pregnancy), end of pregnancy (approx 10 months)||||units on a scale||Standard Deviation|Mean
1305192|NCT02873481|Primary|Feasibility of Retention/ Adherence|Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions|through study completion, an average of 20 weeks||||Participants|||Count of Participants
1305193|NCT02873429|Secondary|Clinical Global Impression of Change (CGI)|Patient's rating of current symptom level compared to baseline assessment using a five-point bipolar scale: Much better(2), Somewhat better(1), No change(0), Somewhat worse(-1), Much worse(-2)|6-8 weeks||||participants|||Number
1305194|NCT02873429|Primary|PROMIS Pain Interference|"Computerized adaptive test measuring interference of pain in everyday functioning using five-point Likert-type scales with two types or response options (i.e., not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5, and never=1, rarely=2, sometimes=3, often=4, always=5). Scores on the items are summed to create a raw score. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net for details of CAT administration and scoring)."|6-8 weeks||||T-score metric||Standard Deviation|Mean
1305195|NCT02873429|Primary|PROMIS Pain Intensity|PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net/promis-scoring-manuals for details ).|6-8 weeks||||T-score metric||Standard Deviation|Mean
1305196|NCT02873104|Secondary|Subject Discomfort and Pain Levels During Treatment|"Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals No pain and 10 equals Worst possible pain."|12 weeks||||units on a scale||Standard Deviation|Mean
1305197|NCT02873104|Secondary|Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.|"Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals very dissatisfied and 5 equals very satisfied."|12 weeks||||units on a scale||Standard Deviation|Mean
1305198|NCT02873104|Secondary|Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.|"Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals no change and 4 equals Very Significant Improvement."|12 weeks||||units on a scale||Standard Deviation|Mean
1305199|NCT02873104|Primary|Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment|Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement|12 weeks||||cm||Standard Error|Mean
1305200|NCT02871375|Secondary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score|The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.|Day 14, each product|Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.|||units on a scale||Standard Deviation|Mean
1305201|NCT02871375|Primary|Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.|Day 14, each product|Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.|||logMAR||Standard Deviation|Mean
1305202|NCT02870205|Primary|Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)|The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).|Baseline and day 14|The FAS was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.|||units on a scale||Standard Deviation|Mean
1305203|NCT02869451|Secondary|Number of Voluntary Withdrawals From the Project|The number of participants who withdraw from the study will be evaluated as a measure of treatment feasibility and acceptability|Evaluated at 6 month follow-up||||Participants|||Count of Participants
1305204|NCT02869451|Secondary|Number of Missed Behavioral Counseling Sessions|Participants attend telephone counseling sessions. Number of missed sessions for the total group will be assessed as a measure of acceptability of the behavioral counseling|3 month follow up||||missed counseling sessions|||Number
1305205|NCT02869451|Secondary|Percentage of Missing Mobile Contingency Management Video Recordings|Participants upload video recordings of abstinence verification as part of contingency management treatment. Percentage of missed videos (compared to expected videos) will be assessed as a measure of feasibility of the contingency management intervention|3 month follow up||||percent missed video recordings|||Number
1305207|NCT02869451|Secondary|Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit|Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date|7 days prior to quit date, 6 month follow up||||number of cigarettes per wk||Standard Deviation|Mean
1305208|NCT02869451|Secondary|Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group)|Participants will self-report number of days marijuana used in the past 30 days and this will be compared for the entire group to self-reported number of days of use in 30 days prior to quit. The proportion will be calculated by totaling baseline days used and pretreatment days used, and then dividing baseline days used by pretreatment days used.|30 days prior to quit date, 6 month follow up||||percentage of pre-quit use|||Number
1305209|NCT02869451|Secondary|Change From Baseline in Number of Days Per Week of Cannabis Use|Participants will self-report amount of marijuana used in past week; this will be compared to self-reported amount smoked per week prior to quit date.|baseline, 6 month follow up||||days per week of marijuana use||Standard Deviation|Mean
1305210|NCT02869451|Secondary|Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine|Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.|3 month follow up||||Participants|||Count of Participants
1305211|NCT02869451|Secondary|Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine|Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.|3 month follow up||||Participants|||Count of Participants
1305212|NCT02869451|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana|7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.|3 month follow up||||Participants|||Count of Participants
1305213|NCT02869451|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|3 month follow up||||Participants|||Count of Participants
1305214|NCT02869451|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking|30-day point prevalence abstinence is defined as no smoking in the prior 30 days.|6 month follow up||||Participants|||Count of Participants
1305215|NCT02869451|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana|30-day point prevalence abstinence is defined as no marijuana use in the prior 30 days.|6 month follow up||||Participants|||Count of Participants
1305216|NCT02869451|Secondary|Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana|7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.|6 month follow up||||Participants|||Count of Participants
1305217|NCT02869451|Secondary|Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|6 month follow up||||Participants|||Count of Participants
1305218|NCT02869451|Primary|Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid|Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.|6 month follow up||||Participants|||Count of Participants
1305219|NCT02869451|Primary|Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use|Participants self-report marijuana use since marijuana quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial quit date.|6 month follow up||||Participants|||Count of Participants
1305220|NCT02869451|Primary|Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine|Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.|6 month follow up||||Participants|||Count of Participants
1305221|NCT02869451|Primary|Number of Participants Who Self-report Prolonged Abstinence From Smoking|Participants self-report smoking behavior since smoking quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial smoking quit date.|6 month follow up||||Participants|||Count of Participants
1305222|NCT02867150|Primary|Fat Reduction in Treatment Zone as Measured in Inches Lost|Circumferential measurement of thighs, hips and waist before and after treatment.|Single 32-minute treatment session||||inch||Full Range|Mean
1305223|NCT02865083|Secondary|Need for Hospital Readmission or Emergency Room Visits|To determine if there is a difference in need for hospital readmission or emergency room visits between the treatment group and the control/standard group.|6 weeks|Data were not collected.||||||
1305224|NCT02865083|Secondary|Other Complication Rate|To determine if there is a difference in other complication rates between the treatment group and the control/standard group.|6 weeks|Data were not collected.||||||
1305225|NCT02865083|Secondary|Postoperative Length of Stay|To determine if there is a difference in postoperative length of stay between the treatment group and the control/standard group.|3-4 days|Data were not collected.||||||
1305226|NCT02865083|Secondary|Estimated Blood Loss|To determine if there is a difference in estimated blood loss between the treatment group and the control/standard group.|At time of surgery|Data were not collected.||||||
1305227|NCT02865083|Secondary|Change in Hemoglobin|To determine if there is a difference in change in hemoglobin between the control/standard group and the treatment group.|24 hours after surgery|Data were not collected||||||
1305228|NCT02865083|Secondary|Duration of Surgery or Length of Time From Skin Incision to Delivery of the Infant|To determine if there is a difference in duration of surgery or length of time from skin incision to delivery of the infant between the treatment group and the control/standard group.|At time of surgery|Data were not collected.||||||
1305229|NCT02865083|Primary|Wound Disruption Rates|To determine if there is a difference in wound disruption rates, in obese patients who have Cesarean sections when the Traxi retractor is used during Cesarean sections, when compared to traditional pannus retractor techniques, montogmery straps.|24 hours from placement of device|Patient data not collected||||||
1305230|NCT02864732|Secondary|Patient Satisfaction Survey|"Satisfaction level with the interventions. Subjects were asked rate their satisfaction with the treatment by choosing one of the following statements:~Very satisfied Satisfied Neutral Unsatisfied Very unsatisfied"|only post-treatment at 6 weeks||||Participants|||Count of Participants
1305264|NCT02862106|Secondary|Change From Baseline by Visit for Serum HBV DNA||week95,108,120,144|intention to treat population|||log_10 IU/mL||Standard Deviation|Mean
1305231|NCT02864732|Secondary|Paraspinal Muscle Strength|"The paraspinal muscle strength was assessed using the Biodex 3 Pro dynamometer (20 Ramsey Rd, Shirley, NY 11967). Active extension of the trunk was performed with the subject in a semi-standing position; the subject’s hips were flexed at 60 degrees with the feet resting on an adjustable footrest. The thighs were secured to the seat with two Velcro straps. The scapulae rested against a roll that is attached to the chair arms. The trunk was secured with two Velcro straps that crossed the front trunk forming the shape of an X. The subject was asked to extend the trunk by exerting maximal isometric contraction for 5 seconds against the scapular roll. The average of three 5-second trials was recorded. All subjects received the same verbal instruction: Push your trunk against the scapular roll as strong as you can. The higher the score the stronger the muscles. The range starts from 0 without a limit to the amount of force that could be exerted."|Baseline - 6 weeks (post-treatment)||||Nm||Standard Deviation|Mean
1305232|NCT02864732|Secondary|Fear-avoidance Behavior Questionnaire|The Fear-avoidance Behavior Questionnaire (FABQ) measure avoidant behavior to physical activity or work due to fear of pain. The has two sub scales: physical activity and work. This FABQ consists of 16 items; 5 items for the physical activity sub scale and 11 items for the work subscale. Each item is scored from 0-6. Higher scores on the FABQ are indicative of greater fear and avoidance beliefs. The total score on the FABQ is 66, however, this score is considered separately. The FABQ-physical activity sub scale ranges from 0 - 24 points and the FABQ-work activity ranges from 0 - 42 points.|Baseline to 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
1305233|NCT02864732|Secondary|Numeric Pain Rating Scale (NPRS)|The NPRS measures pain intensity on an 11-point scale from 0 (no pain) to 10 (maximum pain). The higher the score the worst the pain intensity|Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up)||||units on a scale||Standard Deviation|Mean
1305234|NCT02864732|Primary|Modified Oswestry Disability Questionnaire (MODQ)|The MODQ is a self-reported measure of disability consisting of 10 domains of functional activities related to low back pain. The domains include pain intensity, personal care, lifting, walking, standing, sitting, traveling, social life, employment/homemaking, and sleeping. Each domain is rated from 0 - 5. The total of all the domains range from 0 - 50. The scores can be multiplied by 2 to get a percentage of functional disability. The higher the percentage the higher the disability.|Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).||||percentage of functional disability||Standard Deviation|Mean
1305235|NCT02864732|Primary|Tolerability of Electrical Stimulation (NMES)|"NMES tolerability was performed by asking each subject in the stab + NMES group to describe their subjective perception of both the intensity and discomfort of the NMES current using the descriptors listed in a table. The descriptors represent two distinct domains of adjectives: the sensory aspect of the perceived intensity of stimulation and the affective aspect of the perceived discomfort. Each aspect has 15 adjectives. Each subject was asked to describe the current using the descriptors listed for each aspect at baseline and at 6 weeks.~To analyze the the subjects description of the current, the 15 descriptors of each aspect were divided into 3 zones (high, medium, low). The top 5 descriptors in each aspect were considered high, the middle 5 descriptors were considered medium, and the bottom descriptors were considered low.~Descriptive statistics were used to compare the subjects description of each aspect at baseline and at 6 weeks follow-up."|Participants were followed from baseline to 6 weeks|This outcome measure was only used with the Stabilization plus Electrical Stimulation|||Participants|||Count of Participants
1305236|NCT02863198|Secondary|Pregnancy Rate Between the Study and the Control Group|detection of serum pregnancy tests for both groups( study and the control group)|3 weeks||||participants|||Number
1305237|NCT02863198|Primary|Spiral Artery Doppler Resistance Indices in All Patients|Spiral artery Doppler resistance indices between study and control groups on the day of human chorionic gonadotropin administration.it is an indicator of resistance of Spiral artery to perfusion . In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|one week||||index||Standard Deviation|Mean
1305238|NCT02863198|Primary|Spiral Artery Pulsatility Indices in All Patients|Spiral artery Doppler pulsatility indices between study and control groups on the day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|one week||||index||Standard Deviation|Mean
1305239|NCT02863198|Primary|Appearance of Sub Endometrial Blood Flow in All Patients|Appearance of sub endometrial blood flow between patients of study and control groups on the day of human chorionic gonadotropin administration. subendometrial blood flow distribution pattern was determined by demonstrating pulsatile color signals in the sub endometrial area.The number of patients demonstrating subendometrial blood flow distribution pattern are collected .|one week||||participants|||Number
1305240|NCT02863198|Primary|Measurement of Uterine Artery Resistance Index|measurement of uterine artery resistance index at day of human chorionic gonadotropin administration.it is an indicator of resistance of uterine artery to perfusion . In ultrasonography, it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|one week||||index||Standard Deviation|Mean
1305241|NCT02863198|Primary|Measurement of Uterine Artery Pulsatility Index|measurement of uterine artery pulsatility index at day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance.|one week||||index||Standard Deviation|Mean
1305242|NCT02862730|Secondary|Mean Amount of Glucagon Delivered|Assess the average amount of insulin delivered in units/kg as documented through the artificial pancreas controller in dual hormone arm.|entire 84 hour study|The twenty subject analyzed completed all four arms.|||mcg/kg||Standard Deviation|Mean
1305243|NCT02862730|Secondary|Mean Amount of Insulin Delivered|Assess the average amount of insulin delivered in units/kg as documented through the artificial pancreas controller across all four arms.|entire 84 hour study|The twenty subjects analyzed completed all four arms.|||units/kg||Standard Deviation|Mean
1305244|NCT02862730|Secondary|Number of Events With Capillary Blood Glucose < 3.0 mmol/L|Assess number of events with capillary blood glucose < 3.0 mmol/L using downloads from a Contour Next blood glucose meter across all four arms.|entire 84 hour study|The twenty subjects analyzed completed all four arms.|||number of events||Standard Deviation|Mean
1305245|NCT02862730|Secondary|Number of Events With Capillary Blood Glucose < 3.9 mmol/L|Assess number of events with capillary blood glucose < 3.9 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. .|entire 84 hour study|The twenty subjects analyzed completed all four arms.|||number of events||Standard Deviation|Mean
1305246|NCT02862730|Secondary|Percent of Time With Sensed Glucose > 10 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values greater than 10 mmol/L using Dexcom sensor downloads across all four arms|entire 84 hour study|The twenty subjects analyzed completed all four arms.|||percentage of 84 hours||Standard Deviation|Mean
1305247|NCT02862730|Secondary|Percent of Time With Sensed Glucose < 3.0 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.0 mmol/L using Dexcom sensor downloads across all four arms.|entire 84 hour study|The twenty subjects analyzed completed all four arms.|||percentage of 84 hours||Standard Deviation|Mean
1305248|NCT02862730|Secondary|Number of Carbohydrate Treatments|Assess the number of rescue carbohydrate treatments per day across all four arms.|entire 84 hour study|The twenty subjects analyzed completed all four arms.|||number of carbohydrate treatments/day||Standard Deviation|Mean
1305249|NCT02862730|Secondary|Mean Sensed Glucose|Assess the mean sensor glucose using Dexcom sensor downloads across all four arms.|entire 84 hour study|The twenty subject analyzed completed all four arms|||mmol/L||Standard Deviation|Mean
1305250|NCT02862730|Primary|Percent of Time With Sensed Glucose Between 3.9-10 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.|From 14:00-18:00 for each 12 hour inpatient visit|The twenty subjects analyzed completed all four arms.|||percentage of 4 hours after exercise||Standard Deviation|Mean
1305251|NCT02862730|Primary|Percent of Time With Sensed Glucose Between 3.9-10 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.|entire 84 hour study|The twenty subjects analyzed completed all four arms.|||percentage of 84 hours||Standard Deviation|Mean
1305252|NCT02862730|Primary|Percent of Time With Sensed Glucose < 3.9 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.|From 14:00-18:00 for each 12 hour inpatient visit|The twenty subjects that were analyzed completed all four arms.|||percentage of 4 hours after exercise||Standard Deviation|Mean
1305253|NCT02862730|Primary|Percent of Time With Sensed Glucose < 3.9 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.|entire 84 hour study|The twenty subjects analyzed are the subjects that completed all four arms.|||percentage of 84 hours||Standard Deviation|Mean
1305254|NCT02862600|Secondary|Change From Baseline in the Six-minute Walk Test at the End of Period 1|At the conclusion of 8 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline.|end of Period 1 (Week 8)||||meters||Standard Deviation|Mean
1305255|NCT02862600|Secondary|Change From Baseline in the Six-minute Walk Test at the End of Period 2|At the conclusion of 16 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline.|end of Period 2 (Week 16)||||meters||Standard Deviation|Mean
1305256|NCT02862600|Secondary|Change From Baseline of VO2MAX at End of Period 1|At the conclusion of 8 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline.|end of Period 1 (Week 8)||||ml/kg/min||Standard Deviation|Mean
1305257|NCT02862600|Primary|Change From Baseline of VO2MAX at 16 Weeks|At the conclusion of 16 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline.|end of Period 2 (Week 16)||||ml/kg/min||Standard Deviation|Mean
1305258|NCT02862574|Secondary|Plasma Concentration of Andecaliximab|The plasma concentrations of andecaliximab were not collected and were not analyzed.|Day 4 or 6 (± 1 day)|||||||
1305259|NCT02862574|Secondary|Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug|||percentage of participants|||Number
1305260|NCT02862574|Secondary|Percentage of Participants That Achieve DAS28(CRP) ≤ 3.2 at Week 12|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug|||percentage of participants|||Number
1305261|NCT02862574|Primary|Change From Baseline in DAS28(CRP) at Week 12|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline; Week 12|Participants in the Full Analysis Set (all randomized participants who received at least 1 dose of study drug) with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1305262|NCT02862106|Secondary|Change From Baseline by Vsit for HBeAg Titer.|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|week95,108,120,144|intend to treat population|||IU/ML||Standard Deviation|Mean
1305263|NCT02862106|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;||week95,108,120,144|intent to treat population|||percentage of participants|||Number
1305269|NCT02862106|Secondary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144||week95,108,120,144|Intention to treat population|||percentage of paricipant|||Number
1305270|NCT02862106|Primary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint (LOCF), up to 144 weeks|Intent-to-treat population|||percentage of participants|||Number
1305271|NCT02861664|Secondary|Change From Baseline in Tactile Threshold at Week 4 and 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|At Baseline, Week 4 and Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Number of participants analyzed is the number of participants from ITT population evaluated at specific time point for each treatment arm respectively.|||g||Standard Deviation|Mean
1305272|NCT02861664|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 4|The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At Baseline and Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated at Week 4.|||score on a scale||Standard Deviation|Mean
1305273|NCT02861664|Primary|Change From Baseline in Schiff Sensitivity Score at Week 8|The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At Baseline and Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1305274|NCT02856880|Secondary|AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.|||live:dead stain ratio*min||Standard Error|Least Squares Mean
1305275|NCT02856880|Secondary|AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.|||regrowth ratio*min||Standard Error|Least Squares Mean
1305276|NCT02856880|Secondary|AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.|||plaque incubation pH*min||Standard Error|Least Squares Mean
1305277|NCT02856880|Primary|Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control|AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.|Baseline up to 90 minutes (min)|The Per Protocol (PP) population defined as those participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violation.|||plaque incubation pH*min||Standard Error|Least Squares Mean
1305278|NCT02855411|Secondary|Number of Participants With Abnormalities in Physical Examination|A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination is focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305279|NCT02855411|Secondary|Number of Participants With Abnormalities in Neurological Examination|The extended neurological examination includes observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze-evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination includes an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function is complemented by the Scale for the Assessment and Rating of Ataxia (SARA), a clinical scale based on a semi-quantitative assessment of cerebellar ataxia on an impairment level.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305361|NCT02840916|Secondary|Body Fat Percentage (BFP)|The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks||||% of body weight||Standard Deviation|Mean
1305280|NCT02855411|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs criteria of potential clinical concern: 1) systolic blood pressure <90 millimeters of mercury (mm Hg); 2) change from baseline of systolic blood pressure >=30 mm Hg; 3) diastolic blood pressure <50 mm Hg; 4) change from baseline of diastolic blood pressure >=20 mm Hg; 5) supine pulse rate <40 or >120 beats per minute (bpm); 6) standing pulse rate <40 or >140 bpm.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305281|NCT02855411|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG criteria of potential clinical concern: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): greater than or equal to (>=) 140 milliseconds (msec), >=50% increase from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% increase when baseline is greater than (>) 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected using Fridericia’s formula): absolute value of 450 to less than (<) 480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305282|NCT02855411|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality is assessed. Laboratory test parameters include hematology, clinical chemistry, urinalysis, follicle stimulating hormone, urine drug screen, and pregnancy test.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305283|NCT02855411|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) occurring following start of treatment or increasing in severity in any period were to be considered as a treatment emergent AE.|For AEs, the time frame was from taking first dose through and including last visit (28 days after the last dose), up to 113 days. For SAEs, the time frame was from the time that the participant provided informed consent to last visit, up to 143 days.|Study was terminated before participants were treated. No AE data was collected and there were no SAEs reported during the screening phase.||||||
1305284|NCT02855411|Secondary|CGI-I (Clinical Global Impression–Improvement) at Week 12|The CGI-I consists of a single 7 point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, “Compared to your patient’s condition at the beginning of treatment, how much has your patient changed?” Scores are: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; or 7=Very much worse. For the CGI-I, the participant’s condition at the Day 1 (baseline) visit is the criterion for judging improvement at subsequent visits.|Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305285|NCT02855411|Secondary|Change From Baseline in the CGI‑S (Clinical Global Impression–Severity) to Week 12|The CGI­-S consists of a single 7 point rating score of illness severity. Raters select 1 response based on the following question, “Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?” Scores are: 1=Normal, not ill at all; 2=Borderline mentally ill; 3=Mildly ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; or 7=Among the most severely ill participants.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305286|NCT02855411|Secondary|Change From Baseline in the SCI‑PANSS Positive, Negative and General Psychopathology Subscales to Week 12|The SCI-­PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The Subscale scores are the sum of corresponding individual items.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305287|NCT02855411|Secondary|Change From Baseline in the SCI‑PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12|The SCI-PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The sum of the 30 items is defined as the total score.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305288|NCT02855411|Secondary|Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305289|NCT02855411|Secondary|Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1312567|NCT02502487|Secondary|Oxygen Saturation by Pulse Before Gel Administration||before gel administration||||percentage||Inter-Quartile Range|Median
1305290|NCT02855411|Secondary|Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms. The MCCB neurocognitive score contains all of the tests and domains of the MCCB composite score with the exception of social cognition.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305291|NCT02855411|Secondary|Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"C-SSRS responses are mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). C-SSRS assesses whether participant experienced following: completed suicide (Category 1); suicide attempt (Category 2) (response of “Yes” on “actual attempt”); preparatory acts toward imminent suicidal behavior (Category 3) (“Yes” on “aborted attempt”, or “interrupted attempt”, or “preparatory acts or behavior”); suicidal ideation (Category 4) (“Yes” on “wish to be dead”, or “non-specific active suicidal thoughts”, or “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent”); self-injurious behavior, no suicidal intent (Category 7) (“Yes” on “has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories was to be assessed."|Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305292|NCT02855411|Secondary|Scale for the Assessment and Rating of Ataxia (SARA)|SARA is a clinical scale that is based on a semi­-quantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305293|NCT02855411|Primary|Change From Baseline in the UPSA‑VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment – Validation of Intermediate Measures) to Week 12|The UPSA-VIM is a functional capacity measure of 5 general skills that were previously identified as essential to functioning in the community: general organization, finance, social/communications, transportation, and household chores. The UCSD Performance Based Skills Assessment involves role play tasks that are administered as simulations of events that the person might encounter in the community.|Baseline, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305294|NCT02855411|Primary|Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers’ recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
1305295|NCT02855086|Secondary|Incidence of Adverse Events|The incidence of serious and non-serious adverse events is reported as the number of adverse events (Grade 2 or higher), as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Data are reported by number of events by treatment level.|Up to 30 days||||Adverse events|||Number
1305296|NCT02855086|Primary|Tumor to Background Ratio (TBR)|Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student’s T test for each specimen.|1 day||||Fluorescence Tumor to background ratio||Full Range|Mean
1305297|NCT02854527|Secondary|Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
1305298|NCT02854527|Secondary|Area Under the Curve of Metformin From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
1305299|NCT02854527|Secondary|Area Under the Curve of Furosemide From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of furosemide in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
1305300|NCT02854527|Secondary|Area Under the Curve of Digoxin From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
1305318|NCT02852265|Primary|Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)|Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception|6 months|All enrolled subjects, new or worsening side effects after 6 months of use in women using both an implant and a COC|||participants|||Number
1305301|NCT02854527|Primary|Maximum Concentration of Rosuvastatin (Cmax)|This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol/L||Standard Error|Geometric Mean
1305302|NCT02854527|Primary|Area Under the Curve of Rosuvastatin From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
1305303|NCT02854527|Primary|Maximum Concentration of Metformin (Cmax)|This outcome measure presents the maximum measured concentration of metformin in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration|PKS|||nmol/L||Standard Error|Geometric Mean
1305304|NCT02854527|Primary|Area Under the Curve of Metformin From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
1305305|NCT02854527|Primary|Maximum Concentration of Furosemide (Cmax)|This outcome measure presents the maximum measured concentration of furosemide in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration|PKS|||nmol/L||Standard Error|Geometric Mean
1305306|NCT02854527|Primary|Area Under the Curve of Furosemide From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of furosemide in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
1305307|NCT02854527|Primary|Maximum Concentration of Digoxin (Cmax)|This outcome measure presents the maximum measured concentration of digoxin in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nanomole per liter (nmol/L)||Standard Error|Geometric Mean
1305308|NCT02854527|Primary|Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error. CI - confidence interval, gMean - geometric mean.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|The Pharmacokinetic (PK) analysis set (PKS) included all randomized subjects who were documented to have taken at least 1 dose of study drug and who have provided at least 1 primary or secondary PK endpoint that was not excluded from analysis due to non-evaluability or protocol violation relevant for the evaluation of the pharmacokinetics.|||nanomole hour per liter (nmol·h/L)||Standard Error|Geometric Mean
1305309|NCT02852434|Secondary|Overall Pain Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Postoperative; Assessed once 10 minutes after procedure|Participants who completed the protocol are included in the analysis|||units on a scale||Standard Deviation|Mean
1305310|NCT02852434|Secondary|Speculum Placement Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Intraoperative; Immediately following speculum placement|Participants who completed the protocol are included in the analysis|||units on a scale||Standard Deviation|Mean
1305311|NCT02852434|Secondary|Baseline Pain Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Immediately prior to procedure|Participants who completed the protocol are included in the analysis|||units on a scale||Standard Deviation|Mean
1305312|NCT02852434|Secondary|Anticipated Pain Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Preoperative; 30 minutes prior to procedure|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
1305313|NCT02852434|Primary|Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion|Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Intraoperative; Immediately (0-30 seconds) following cervical dilation|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
1305314|NCT02852265|Secondary|Post-study Method Plan (Measurement: Participant Interview)|Plan to continue the COC and/or implant after the study based on interview at last visit|6 months|||||||
1305315|NCT02852265|Secondary|COC Continuation Rate (Measurement: Participant Interview)|Continuation rate of COC over 6 months of evaluation based on whether or not the implant was still present at 6 months|6 months|||||||
1305316|NCT02852265|Secondary|Bleeding Patterns (Measurement: Diaries)|Bleeding patterns while using a COC concomitantly with ENG implant|6 months|||||||
1305317|NCT02852265|Secondary|Patient Interest (Measurement: Ability to Enroll)|Demonstrate that women desiring a COC are willing to use ENG implant concomitantly as a continuous “back-up” contraceptive|6 months|||||||
1305319|NCT02852265|Primary|Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)|Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception|6 months|All women enrolled in study|||Participants|||Count of Participants
1305320|NCT02851823|Primary|Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)|"Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 1 month.~Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 3 month."|Baseline, 1 and 3 months||||mm||Standard Deviation|Mean
1305321|NCT02851823|Primary|Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)|Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 1 month Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 3 month|Baseline, 1 and 3 months||||mm||Standard Deviation|Mean
1305322|NCT02850159|Primary|Change of Freezing of Gait Questionnaire (FOG-Q)|Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.|Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5||||score||Standard Deviation|Mean
1305323|NCT02849678|Secondary|Consumption of Nerve Block Boluses Will Also be Recorded Daily|During the hospitalization following surgery until discontinuation of the block or discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Lopi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis.|||milliliters||Full Range|Median
1305324|NCT02849678|Secondary|Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent)|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Ropi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis.|||Milligrams||Full Range|Mean
1305325|NCT02849678|Secondary|Number of Patients With Complications (Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.)|During the hospitalization following surgery until discharge.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||Participants|||Count of Participants
1305326|NCT02849678|Secondary|Hospital Length of Stay.|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Lopi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis.|||days||Full Range|Median
1305327|NCT02849678|Secondary|Time to First Flatus/Defecation|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||Postoperative days||Full Range|Median
1305328|NCT02849678|Secondary|Time to First Ambulation(Walking Greater Than 15 Feet)|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Ropi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, technical issues with block excluded 5 patients from analysis (considered protocol violations).|||days||Full Range|Median
1305329|NCT02849678|Primary|11-point Verbal Numerical Rating Scale (NRS) Pain Assessment|The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain.|24 hours from the end of surgery|Patients undergoing elective laparoscopic bowel surgery with bilateral thoracic paravertebral continuous nerve blocks.|||Scores on a scale||Full Range|Median
1305330|NCT02848222|Primary|Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)||Baseline through 1 month|In Gr1, 25 subjects were randomized, 18 subjects completed, 7 discontinued early and 1 subject's data was not used due to poor compliance resulting in 17 subjects analyzed. In Gr2, 18 subjects were randomized and 17 completed. In Gr3, 17 subjects were randomized and completed.|||hours per day||Standard Deviation|Mean
1305331|NCT02847260|Secondary|Change From Baseline to Week 16 in HemodynamicParameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)|Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular load. The PVRI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.|||mmHg*min*m^2/L||Standard Deviation|Mean
1305332|NCT02847260|Secondary|Change From Baseline to Week 16 in Hemodynamic Parameters: Cardiac Index (CI) (L/Min/m^2)|Cardiac Index (CI) relates the cardiac output (CO) to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.|||L/min/m^2||Standard Deviation|Mean
1305605|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305333|NCT02847260|Secondary|Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm).|Pulmonary hypertension, an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by Swan-Ganz right heart catheterization. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.|||mmHG||Standard Deviation|Mean
1305334|NCT02847260|Secondary|Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 16.|The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, negative change scores indicate improvements.|Baseline to week 16|Scores could not be tabulated for one subject due to missing responses to individual questions|||units on a scale||Full Range|Median
1305335|NCT02847260|Secondary|Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.|The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline to week 16||||Participants|||Count of Participants
1305336|NCT02847260|Secondary|Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 16.|The level of this biomarker of the (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 16.|Baseline to week 16||||pg/mL||Full Range|Median
1305337|NCT02847260|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 16|The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the 6MWT. The Borg dyspnea score was assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline to week 16|Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.|||units on a scale||Full Range|Median
1305338|NCT02847260|Secondary|Change From Baseline in Six Minute Walk Distance at Week 16.|The purpose of the six minute walk test (6MWT) was to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500 - 800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline to week 16|Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.|||meters||Full Range|Median
1305339|NCT02847260|Primary|Number of Participants With Successful Completion of the 16 Week Treatment Period.|Successful completion was defined as completion of the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.|Baseline to week 16||||participants|||Number
1305340|NCT02847169|Primary|Rotational Recovery in Degrees After 60 Seconds|Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.|Baseline and 1 week||||degrees||Standard Deviation|Mean
1305341|NCT02847169|Primary|Lens Orientation in Primary Position of Gaze|Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.|Baseline and 1 week||||percentage of participants|||Number
1305342|NCT02847169|Primary|Corneal Coverage|Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)|Baseline and 1 week||||participants|||Number
1305343|NCT02847169|Primary|Overall Stability|Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1305344|NCT02847169|Primary|Post-blink Movement|Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1305345|NCT02847169|Primary|Lens Centration|Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).|Baseline and 1 week||||percentage of participants|||Number
1305346|NCT02847169|Primary|Overall Fit Acceptance|Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1305347|NCT02846558|Secondary|Self-esteem|The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self. Individual items are summed to calculate the total score. Minimum score is 0 and maximum score is 30. Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem. An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants.|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||scores on a scale||Standard Deviation|Mean
1305348|NCT02846558|Secondary|Sleep Quality|The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults. It differentiates “poor” from “good” sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21. A total score equal to or greater than 5 units indicates “poor” quality sleep, while a score of 0-4 indicates “good” quality sleep; lower scores indicate better sleep quality. Decrease in PSQI score indicates a better outcome, or improved sleep quality, among study participants.|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||scores on a scale||Standard Deviation|Mean
1305349|NCT02846558|Secondary|Fatigue|The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue is a question bank of 95 items validated to evaluated fatigue in a variety of chronic conditions. The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue in people with multiple sclerosis. Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40. Lower scores indicate less fatigue, while higher scores indicate more fatigue. Reduction in score over 6 months indicates a better outcome, or improved fatigue among participants.|Baseline and 6 months|Discrepancy in numbers is due to non-completers|||scores on a scale||Standard Deviation|Mean
1305350|NCT02846558|Secondary|Functional Assessment in MS Score|The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS. The instrument contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thanking/fatigue, and family/social wellbeing. Subscores for each area is calculated as the sum of responses in that section, and the total FAMS score is the sum of all subscores. Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life. Increase in the FAMS score over the study period indicates a better outcome, or improved quality of life, among participants.|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||scores on a scale||Standard Deviation|Mean
1305351|NCT02846558|Secondary|Weight Change Among Adherent Participants|The change in weight over 6 months among participants were remained adherence to the calorie restriction diet versus those who admitted to non-compliance by the end of the study period.|Baseline and 6 months|Discrepancy in numbers is due to non-completers. 5 out of the initial 43 participants dropped out of the study voluntarily|||kg||Standard Deviation|Mean
1305352|NCT02846558|Secondary|Weight Change|Change in participant weight over the 6-month study period|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||KG||Standard Deviation|Mean
1305353|NCT02846558|Secondary|Body Mass Index (BMI)|Change in body mass index from baseline to 6 months.|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||kg/m^2||Standard Deviation|Mean
1305354|NCT02846558|Primary|Adherence|Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.|Baseline and 6 months||||Participants|||Count of Participants
1305355|NCT02844998|Primary|Intravaginal Ejaculatory Latency Time|Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)|Baseline and 30 Days||||seconds||Standard Deviation|Mean
1305356|NCT02844998|Primary|Premature Ejaculation Diagnostic Tool (Total Score)|Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.|Baseline and 30 Days||||scores on a scale||Standard Deviation|Mean
1305357|NCT02844543|Primary|Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain|"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.~Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."|Up to 6 hours|Participants with evaluable data at the respective time point were included in the analysis.|||Ratio of velocity (degrees per second)||Standard Deviation|Mean
1305358|NCT02844543|Primary|Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error|"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.~Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."|Up to 6 hours|Participants with evaluable data at the respective time point were included in the analysis.|||Degrees of variation||Standard Deviation|Mean
1305359|NCT02844543|Secondary|Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score|Change in SCAT-3 SAC score before and after practice or game is reported. The SAC score is based on the following assessments: number of symptoms (22 points), symptom severity (132 points), orientation (5 points), immediate memory (15 points), concentration (5 points), and delayed recall (5 points). Scores are summed for a possible range of 0 to 184, with lower scores corresponding to fewer concussion symptoms, and higher scores corresponding to more concussion symptoms.|Day of study/event (up to 6 hours)|Participants who completed the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
1305360|NCT02844543|Primary|Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error|"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.~Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."|Up to 6 hours|Participants with evaluable data at the respective time point were included in the analysis.|||Degrees||Standard Deviation|Mean
1305606|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1305362|NCT02840916|Secondary|Waist-to-buttock Ratio (WBR)|The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks||||ratio||Standard Deviation|Mean
1305363|NCT02840916|Primary|Body Mass Index (BMI)|The BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion.|up to 3 weeks, 3 months after study completion||||kg/m^2||Standard Deviation|Mean
1305364|NCT02840253|Primary|Tissue Non-invasive Near Infrared Spectroscopy (NIRS)|Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).|Intraoperative measure||||percentage change per minute||95% Confidence Interval|Number
1305365|NCT02840253|Primary|Cerebral Non-invasive Near Infrared Spectroscopy (NIRS)|Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).|Intraoperative measure||||percentage change per minute||95% Confidence Interval|Number
1305366|NCT02839772|Secondary|Amharic Dermatology Life Quality Index (DLQI)|The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.|||units on a scale||Standard Deviation|Mean
1305367|NCT02839772|Secondary|Change in Largest Foot Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||Centimetres|Foot circumference|Standard Deviation|Mean
1305368|NCT02839772|Secondary|Change in Largest Lower Leg Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||Centimetres|Legs|Standard Deviation|Mean
1305369|NCT02839772|Secondary|Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds|Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.|From baseline monthly for 3 months|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be collected and analysed for all participants in a single group.|||Spearman's correlation coefficient|||Number
1305370|NCT02839772|Secondary|Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)|Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be analysed for all participants as a single group.|||Number of work days lost.|||Number
1305371|NCT02839772|Secondary|Number of Wounds on Lower Legs/Feet of Participants.|"Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse.~Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data was pre-specified to be analysed for all participants as a single group.|||Wounds|Feet/legs||Number
1305372|NCT02839772|Secondary|Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.|Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.|||Participants|||Number
1305373|NCT02839772|Secondary|Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit|Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.|||Trophic skin changes|||Number
1305374|NCT02839772|Secondary|Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit|Podoconiosis Staging System (1-5) used with 5 the most severe stage. This staging system was specifically designed for those with podoconiosis. Legs with stages 1, 2 or 3 were categorised with mild/moderate disease and those with stages 4,5 with severe disease.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants as a single group.|||Legs/feet|Legs||Number
1308911|NCT02632110|Secondary|Percent Change|Percent change in the total AK number as compared with Baseline|Baseline and Week 12|split-face|||percent change|AK Fields|Standard Deviation|Mean
1305375|NCT02839772|Primary|Change in Stratum Corneum Hydration at Top of Feet|Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left foot in the control group and one left and one right foot in the experimental group were not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Feet|Standard Deviation|Mean
1305376|NCT02839772|Primary|Change in Stratum Corneum Hydration at Base of Outer Lower Leg|Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Legs|Standard Deviation|Mean
1305377|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.|SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Legs|Standard Deviation|Mean
1305378|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs|Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Legs|Standard Deviation|Mean
1305379|NCT02839772|Primary|Change in TEWL at Top of Feet|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.~TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group. One left foot leg in the control group and one right and one left foot in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Feet|Standard Deviation|Mean
1305380|NCT02839772|Primary|Change in TEWL at Base of Outer Lower Legs|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.~TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post-intervention data was missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Legs|Standard Deviation|Mean
1305381|NCT02839772|Primary|Change in TEWL at Mid-point Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Legs|Standard Deviation|Mean
1305382|NCT02839772|Primary|Change in TEWL at Top of Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data was missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Legs|Standard Deviation|Mean
1305556|NCT02824913|Secondary|Adverse Events|Number of patients experiencing adverse events comparing P-321 to placebo|2 or 7 hours|One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).|||Participants|||Count of Participants
1305383|NCT02838901|Secondary|Modified Rankin Score|Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.|90 days|Only 6 participants in the active and 8 in the placebo returned for the 90 day visit and therefore modified Rankin could not be ascertained.|||units on a scale||Inter-Quartile Range|Mean
1305384|NCT02838901|Secondary|Modified Rankin Score|Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.|30 days|Only 8 participants in the active and 8 in the placebo returned for the 30 day visit in order to measure the modified Rankin score.|||units on a scale||Inter-Quartile Range|Mean
1305385|NCT02838901|Secondary|Montreal Cognitive Assessment (MoCA) Score|Cognition is measured with the Montreal Cognitive Assessment. Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.|90 days|Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 90 days.|||units on a scale||Inter-Quartile Range|Mean
1305386|NCT02838901|Secondary|Montreal Cognitive Assessment (MoCA) Score|Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.|30 days|Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 30 days.|||units on a scale||Inter-Quartile Range|Mean
1305387|NCT02838901|Secondary|Upper Extremity Grip Strength|The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms. The score ranges from 0-90kg, higher score denotes better outcomes.|90 days|Only 6 in the active and 7 in the placebo had grip strength measured at 90 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.|||kg||Inter-Quartile Range|Mean
1305388|NCT02838901|Secondary|Upper Extremity Grip Strength|The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms (kg). The score ranges from 0-90kg, higher score denotes better outcomes.|30 days|Only 6 participants in each group had grip strength measured at 30 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.|||kg||Inter-Quartile Range|Mean
1305389|NCT02838901|Secondary|Cerebral Perfusion Imaging|Participants from each group who had an MRI at baseline will be randomly selected to have a repeat MRI perfusion scan at 30 days. Cerebral blood flow will be measured by MRI perfusion scanning (arterial spin labeling) in the region of the stroke.|30 days|MRI cerebral perfusion data could not be analyzed because of a change in the measurement of perfusion after the first participant was enrolled.||||||
1305390|NCT02838901|Secondary|Gait Speed Change From Baseline|Gait speed is measured by the time it takes to walk 10 meters. Baseline was reported.Change in gait speed from baseline was assessed at 30 and 90 days. Non-ambulatory at baseline is defined as gait speed less than 0.1 m/s.|baseline, 30, and 90 days|There were 8 participants in the Active and 8 in the placebo because they did not follow-up at 30 days. BL ambulatory refers to only those participants were able to walk at baseline immediately after enrollment. For this analysis, there were only 6 participants in the active and 7 in the placebo at 30 days and 4 and 5 at 90 days, respectively.|||m/s||Inter-Quartile Range|Median
1305391|NCT02838901|Primary|Change in Plasma Nitrite Levels, Micromoles/Liter|This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.|after 30 days of treatment|The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants in active and 7 in placebo based on follow-up at 30 d.|||micromoles/L||Inter-Quartile Range|Median
1305392|NCT02838901|Primary|Change in Plasma Nitrate Levels, Micromoles/Liter|This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.|after 30 days of treatment|The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants per group since 2 did not come back for follow-up at 30 days.|||micromoles/L||Inter-Quartile Range|Median
1305393|NCT02838901|Primary|Number of Participants With Adverse Treatment-altering Events|Adverse events that lead to treatment discontinuation|30 days||||participants|||Number
1305394|NCT02838901|Primary|Adherence With Intervention|The primary outcome for this trial is feasibility, which will be measured by how well the participants followed instructions on taking Beet It organic beetroot juice or placebo once a day for 30 days.|30 days|Two participants were lost to follow-up by 30 days, therefore the analysis included 8 participants in each group.|||percentage of participants||Inter-Quartile Range|Mean
1305395|NCT02837952|Secondary|Time to Onset of “Meaningful” Pain Relief After First Dose|"Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first."|Up to 8 hours after first dose|The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1312568|NCT02502487|Secondary|Mean Arterial Pressure After Withdrawal of Cystoscope||after withdrawal of cystoscope||||mmHg||Standard Deviation|Mean
1305396|NCT02837952|Secondary|Duration of Relief After First Dose|Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation.|Up to 8 hours after first dose|The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1305397|NCT02837952|Secondary|Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 [0-8]), -15 (worst score) to 30 (best score) for (SPID11 [6-8]), -80 (worst score) to 160 (best score) for (SPID11 [0-16]), -45 (worst score) to 90 (best score) for (SPID11 [8-16]), -240 (worst score) to 480 (best score) for (SPID11 [0-48]). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose|The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1305398|NCT02837952|Primary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 [0-24]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|0 to 24 hours post dose|The full analysis set (FAS) included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a Scale||Standard Error|Least Squares Mean
1305399|NCT02836249|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1305400|NCT02836249|Secondary|Change From Baseline at Week 48 in Serum Creatinine||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||mg/dL||Standard Deviation|Mean
1305401|NCT02836249|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
1305402|NCT02836249|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
1305403|NCT02836249|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48||Week 48|Serologically Evaluable Full Analysis Set: participants who were randomized, had received at least 1 dose of study drug, and were HBeAg positive and anti-HBe negative or had a value missing value at baseline. Participants were analyzed according to their randomized treatment group. All missing data were treated as no HBeAg seroconversion.|||percentage of participants|||Number
1305404|NCT02836249|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48||Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
1305405|NCT02836236|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1305406|NCT02836236|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|"Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.~Missing data were excluded from analysis."|||mg/dL||Standard Deviation|Mean
1305407|NCT02836236|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
1305601|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1310350|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants||0 weeks (Visit 1)||||errors|||Number
1305408|NCT02836236|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
1305409|NCT02836236|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48||Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
1305410|NCT02834624|Secondary|Change in Number of Tracheal Macrophages|measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate|baseline, 48 hours||||white cells/high-powered field||Standard Deviation|Mean
1305411|NCT02834624|Secondary|Presence of Pulmonary Hemorrhage|Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.|intraoperative|This data is unavailable from the research department as it was not collected.||||||
1305412|NCT02834624|Primary|Change From Baseline in Blood C-reactive (CRP) Protein|Difference between measurement of CRP at baseline and 48 hours after administration of surfactant|baseline, 48 hours||||mg/dL||Standard Deviation|Mean
1305413|NCT02832674|Secondary|Subject Global Satisfaction Questionnaire (S-GSQ)|A subjective assessment of global satisfaction as measured by the participant using the S-GSQ where the participant rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.|Change from baseline at Days 90 and 180|Of the 72 enrolled and treated subjects, 69 completed the day 90 visit and 67 completed the day 180 visit (4 subjects were lost to follow up and one subject withdrew consent)|||percentage of participants||95% Confidence Interval|Mean
1305414|NCT02832674|Secondary|Physician Global Satisfaction Questionnaire (P-GSQ)|A subjective assessment of global satisfaction as measured by the physician using the P-GSQ where the physician rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.|Change from baseline at Days 90 and 180|Of the 72 enrolled and treated subjects, 69 completed the Day 90 visit and 67 the Day 180 (4 subjects were lost to follow up and one withdrew consent).|||percentage of participants||95% Confidence Interval|Mean
1305415|NCT02832674|Secondary|Subject Global Aesthetic Improvement Scale (S-GAIS)|A subjective assessment of overall improvement measured by the participant using the SGAIS where the participant rates the appearance of the treated area (submental area) with respect to “lift”is measured from. the 5-point scale measures from Very much improved to worse.|Change from baseline at Days 90 and 180|of the 72 enrolled and treated subjects, 69 completed the Day 90 visit and 67 completed day 180 (4 subjects were lost to follow up and 1 subject withdrew consent)|||percentage of participants||95% Confidence Interval|Mean
1305416|NCT02832674|Secondary|Physician Global Aesthetic Improvement Scale (P-GAIS)|"A subjective assessment of overall improvement measured by the physician using the PGAIS where the physician rates the appearance of the treated area (submental area) with respect to lift compared to baseline photography at the defined time points. The 5-point scale measures from Very much improved to worse."|Change from baseline at Days 90 and 180|of the 72 enrolled and treated subjects, 69 completed Day 90 and 67 completed the Day 180 visit (4 subjects were lost to follow up and 1 withdrew consent)|||percentage of participants||95% Confidence Interval|Mean
1305417|NCT02832674|Secondary|Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer|Overall improvement of submental lift was determined by a blinded rater panel using before and after photos|Change from baseline to Days 90 and 180|sixty-nine of the 72 enrolled and treated subjects completed visit 5 (Day 90) and 67 completed Visit 6 (Day 180). subjects with non-evaluable images were excluded from the analysis for Day 90 and 180 as applicable|||percentage of participants||95% Confidence Interval|Median
1305418|NCT02832674|Primary|Tissue Lift at the Submental Area Measuring >/= 20 mm2|A >/= 20 mm^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).|Change from baseline at Day 90||||percentage of participants||90% Confidence Interval|Mean
1305419|NCT02832375|Secondary|Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, after single use (after 5 minutes) and on Day 3|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively.|||g||Standard Deviation|Mean
1305420|NCT02832375|Secondary|Change From Baseline in Schiff Sensitivity Score After Single Use|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, after single use (after 5 minutes)|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is the ITT Population evaluated post treatment single usage for each treatment arms.|||score on a scale||Standard Deviation|Mean
1305421|NCT02832375|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 3|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 3.|||score on a scale||Standard Deviation|Mean
1305422|NCT02831660|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events is presented|from first drug administration until 5 days after last drug administration, up to 6 days.|Treated Set|||Percentage of participants|||Number
1305423|NCT02831569|Secondary|Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment|The outcome measure presents percentage of patients who showed “marked improvement” or “moderate improvement” in low back pain and/or scapulohumeral periarthritis and/or cervico-omo-brachial syndrome after 2 weeks of treatment.|Post 2 weeks.|Full Analysis Set [FAS]: The analysis set included patients who received at least one dose of the trial medication during the trial period and have efficacy data at baseline and after the start of treatment. Efficacy analysis was performed on FAS.|||Percentage of participants|||Number
1305424|NCT02831569|Primary|Percentage of Patients With Drug-related Adverse Events [AEs]|The outcome measure presents percentage of patients with drug-related AEs.|Up to 3 weeks.|Treated Set [TS]: The analysis set included patients who received at least one dose of the trial medication during the trial period. Safety analysis was performed on TS.|||Percentage of participants|||Number
1305425|NCT02829996|Other Pre-specified|Safety Parameters, Including Treatment Emergent Adverse Events, to Assess Tolerability and Safety.|Collection of safety parameters, including treatment emergent adverse events, laboratory assessments, to assess tolerability and safety.|Through Study Completion, up to 9 weeks.|||||||
1305426|NCT02829996|Primary|Mean Intraocular Pressure (IOP)|Daily change from diurnal baseline in IOP|Two Months|Intent to treat|||mm of mercury||Standard Error|Mean
1305427|NCT02829983|Secondary|Probing Depth|Distance from the bottom of sulcus/pocket to gingival margin|6 months||||milimeter||Standard Deviation|Mean
1305428|NCT02829983|Primary|Clinical Attachment Level|Distance from bottom of pocket to the cement-enamel junction (CEJ).|6 months||||milimeter||Standard Deviation|Mean
1305429|NCT02829775|Secondary|Number of Participants With Overall Tumor Response|Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.|Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)|All participants who were recruited in the study.|||participants|||Number
1305430|NCT02829775|Primary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.|Baseline up to approximately 3 years|All participants who were recruited in the study.|||participants|||Number
1305431|NCT02829463|Primary|Infrapatellar Fat Pad Volume in MRI||collect the data within 24 hours after the subjects did the MRI||||mm^3||Standard Deviation|Mean
1305432|NCT02829320|Secondary|Duration of Treatment Interruption Due to Hgb >13 g/dL|Hgb values were used for making decision of treatment interruption. On-therapy Hgb values observed in both scheduled and unscheduled visits were counted. Participants who have no treatment interruption due to Hgb >13.0 g/dL are not included|Up to Week 24|All Treated Subjects Population|||Days||Full Range|Median
1305433|NCT02829320|Secondary|Number of Participants With Frequency of Dose Adjustments|Dose adjustment algorithm was used which was based on Hgb values at scheduled visits. Hgb values measured at unscheduled visits were not included. For dose adjustments frequency, the number of participants were provided by the number of dose adjustments (i.e. zero, one, two, three, four, and five or more).|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
1305434|NCT02829320|Secondary|Dose Level of GSK1278863 at Indicated Time Points|Dose adjustment algorithm was used which was based on Hgb values at scheduled visits. Hgb values measured at unscheduled visits were not included. Mean dose during Week 12 to 24 is the average of dose at Weeks 12, 16, and 20.|Up to Week 24|All Treated Subjects Population|||mg||Full Range|Median
1305435|NCT02829320|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC)|Blood samples were collected from participants for measurement of TIBC at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||umol/L||Standard Deviation|Mean
1305436|NCT02829320|Secondary|Change From Baseline in Serum Iron|Blood samples were collected from participants for measurement of serum iron at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1305450|NCT02829320|Secondary|Change From Baseline in Hgb at the Indicated Time Points|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The Baseline value was the latest pre-dose assessment. Change from Baseline at indicated time-points was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||G/dL||Standard Deviation|Mean
1316669|NCT02387710|Secondary|Slow Wave Sleep (% Total Sleep Time)|Fraction of sleep spent in stage N3|1 night||||% total sleep time||Inter-Quartile Range|Median
1305437|NCT02829320|Secondary|Percent Change From Baseline in Hepcidin|Blood samples were collected from participants for measurement of hepcidin at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). If a laboratory value had a non-detectable level reported in the database, where the numeric value was missing, the value was not included in a summary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 24|All Treated Subjects Population|||Percentage of hepcidin||95% Confidence Interval|Geometric Mean
1305438|NCT02829320|Secondary|Percent Change From Baseline in TSAT|Blood samples were collected from participants for measurement of TSAT at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1).|Baseline and up to Week 24|All Treated Subjects Population|||Percentage of transferrin||95% Confidence Interval|Geometric Mean
1305439|NCT02829320|Secondary|Change From Baseline in Ferritin|Blood samples were collected from participants for measurement of serum ferritin at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||Microgram per liter (µg/L)||Standard Deviation|Mean
1305440|NCT02829320|Secondary|Number of Participants Who Used Iron During the Treatment Period|The number of participants who used iron (both IV and oral iron) during the treatment period were summarized.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
1305441|NCT02829320|Secondary|Monthly Average Dose of Intravenous (IV) Iron During the Treatment Period|Records of on-therapy iron medication were used to calculate average quarterly IV iron dose. Quarter 1 = (Randomization Date - Treatment Start Date at Week 12 - 1 [day]). Quarter 2 = (Treatment Start Date at Week 12 - Study Treatment Stop Date). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 24|All Treated Subjects Population|||Mg||Standard Deviation|Mean
1305442|NCT02829320|Secondary|Maximum Observed Concentration (Cmax) of GSK1278863|Blood samples were collected to evaluate Cmax at 1, 2, 3 and 4 hours post dose at Weeks 12 and 24. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indiates data was not available. Geometric coefficient of variation could not be calculated when number of participant was equal to 1.|1, 2, 3 and 4 hours post dose at Weeks 12 and 24|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1305443|NCT02829320|Secondary|Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863|Blood samples were collected to evaluate AUC (0-4) at 1, 2, 3 and 4 hours post dose at Weeks 12 and 24. Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Population consisted of all participants who received GSK1278863 with the PK samples collected and analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indiates data was not available. Geometric coefficient of variation could not be calculated when number of participant was equal to 1.|1, 2, 3 and 4 hours post dose at Weeks 12 and 24|PK Population|||Hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1305444|NCT02829320|Secondary|Number of Episodes of Achieving Hgb Level of More Than 13.0 g/dL|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of episodes in participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Episodes|||Number
1305445|NCT02829320|Secondary|Number of Participants Who Had Hgb Level of More Than 13.0 g/dL|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
1305446|NCT02829320|Secondary|Number of Participants Who Had Hgb Increase of More Than 2 g/dL Over Any 4 Weeks|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb increase of more than 2.0 g/dL over any 4 weeks were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
1305447|NCT02829320|Secondary|Number of Participants Who Had Hgb Level of Less Than 7.5 g/dL|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of less than 7.5 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
1305448|NCT02829320|Secondary|Time to Reach the Lower Target Hgb Level (10.0 g/dL)|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. Participants who could not reach lower target were regarded as censored. The time (in days) to reach the lower target Hgb level (10.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method.|Up to Week 24|All Treated Subjects Population|||Days||Inter-Quartile Range|Median
1305449|NCT02829320|Secondary|Number of Participants Who Had Hgb Level Within the Target Range (10.0–12.0 g/dL)|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants with Hgb withinthe target range (10.0 to 12.0 g/dL) at each assessment visit was summarized.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
1305451|NCT02829320|Secondary|Hgb Values at the Indicated Time Points|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer.|Up to Week 24|All Treated Subjects Population|||G/dL||Standard Deviation|Mean
1351302|NCT01780922|Primary|Nitric Oxide (NO) Concentrations in Plamsa||0, 2, 4, 8, 24 h||||umol/L||Standard Error|Mean
1305452|NCT02829320|Primary|Number of Participants by Hgb Change From Baseline Category at Week 4|Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The change in Hgb at Week 4 was classified into different categories (i.e., <=-2.0, >-2.0 to -1.0, >-1.0 to 0, >0 to 1.0, >1.0 to 2.0, and >2 g/dL), and the number of participants in each category were summarized.|Baseline and Week 4|All Treated Subjects Population|||Participants|||Count of Participants
1305453|NCT02829320|Primary|Change From Baseline in Hgb at Week 4|Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The analysis was performed on All Treated Subjects Population which comprised of all participants who received at least one dose of GSK1278863.|Baseline and Week 4|All Treated Subjects Population|||G/dL||95% Confidence Interval|Mean
1305454|NCT02829138|Secondary|Change in Omega-3 Index in Blood (Physiological Parameter)|Blood fatty acids measured by gas chromatography. Data is reported as a percentage of all detected fatty acids. The omega-3 index is calculated by summing data for 3 omega-3 fats in serum: ALA, EPA, and DHA.|baseline and 12 weeks||||percentage of total fatty acids in serum||Standard Error|Mean
1305455|NCT02829138|Secondary|Change in Blood Triglycerides (Physiological Parameter)|Triglycerides were measured in fasted serum. Data is reported as mmol/L|baseline and 12 weeks||||mmol/L||Standard Error|Mean
1305456|NCT02829138|Primary|Omega-3 Dietary Intake|Omega-3 fat intake was assessed using food frequency questionnaires. The Canadian Nutrient File (version 2015) was used to assess the amount of EPA and DHA in whole foods (e.g., fish, eggs, poultry). Data corresponds to EPA + DHA (mg /day).|Baseline and 12 weeks||||mg/day||Standard Error|Mean
1305457|NCT02828137|Primary|Index of Microcirculatory Resistance|IMR in low NLR group : 21.94 ± 12.87 IMR in intermediate NLR group : 23.22 ± 12.73 IMR in high NLR group : 32.95 ± 20.60|3 months||||IMR||Standard Deviation|Mean
1305458|NCT02826551|Secondary|Pain Pill Count|Patients will log the number of pills they take the first four days after surgery.|Day 0-4 post-operatively|No data.||||||
1305459|NCT02826551|Primary|VAS Scores|VAS Scales recorded in AM and PM|Day 0-4 post-operatively|data were not collected.||||||
1305460|NCT02826421|Secondary|Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)|Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.|Day 0, operative day|Full Analysis Set|||mm||Standard Error|Mean
1305461|NCT02826421|Primary|Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)|Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.|Day 0, operative day|Full Analysis Set|||mm||Standard Error|Mean
1305462|NCT02825550|Secondary|Serum Level of AFP|Serum Level of AFP [Time Frame: Baseline serum AFP levels (168±383) compared with one or three months of serum levels of AFP (144±256) after Taiwan ACE Beads procedure]|Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure||||ng/mL||Standard Deviation|Mean
1305463|NCT02825550|Primary|Tumor Response (Efficacy)|mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.|Before treatment, one month and three month after T-ACE using CT scan and MRI||||Participants|||Count of Participants
1305464|NCT02825550|Primary|Patients Survival (Safety)|Survival rate was evaluated since treatment day until the date of death or final observation.|An average of 12 weeks.||||Participants|||Count of Participants
1305465|NCT02825251|Secondary|Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets|"Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.~Reasons for change-of-infusion-sets are categorised as follows:~Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing"|Week 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305466|NCT02825251|Secondary|Number of Change-of-infusion-sets Per Week|Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of infusion-sets||Standard Deviation|Mean
1305467|NCT02825251|Secondary|Change From Baseline in Body Mass Index (BMI)|Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||kg/m^2||Standard Deviation|Mean
1305468|NCT02825251|Secondary|Change From Baseline in Body Weight|Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Kg||Standard Deviation|Mean
1305469|NCT02825251|Secondary|Change From Baseline in Urinalysis: Ketones|Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305470|NCT02825251|Secondary|Change From Baseline in Urinalysis: Protein|Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305471|NCT02825251|Secondary|Change From Baseline in Urinalysis: Erythrocytes|Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305472|NCT02825251|Secondary|Change From Baseline in Urinalysis: Albumin/Creatine Ratio|Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mg/mmol||Standard Deviation|Mean
1305473|NCT02825251|Secondary|Change From Baseline in Biochemistry: Total Bilirubin|Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||umol/L||Standard Deviation|Mean
1305474|NCT02825251|Secondary|Change From Baseline in Biochemistry: Albumin|Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||g/dL||Standard Deviation|Mean
1305475|NCT02825251|Secondary|Change From Baseline in Biochemistry: Potassium|Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305476|NCT02825251|Secondary|Change From Baseline in Biochemistry: Sodium|Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305477|NCT02825251|Secondary|Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)|Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/L||Standard Deviation|Mean
1305478|NCT02825251|Secondary|Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)|Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/L||Standard Deviation|Mean
1305479|NCT02825251|Secondary|Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)|Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/L||Standard Deviation|Mean
1305480|NCT02825251|Secondary|Change From Baseline in Biochemistry: Creatinine|Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||umol/L||Standard Deviation|Mean
1305481|NCT02825251|Secondary|Change From Baseline in Biochemistry: Total Protein|Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||g/dL||Standard Deviation|Mean
1305517|NCT02825251|Secondary|Change From Baseline in AUCIG,0-15min|Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305482|NCT02825251|Secondary|Change From Baseline in Haematology: Leucocytes|Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||10^9/L||Standard Deviation|Mean
1305483|NCT02825251|Secondary|Change From Baseline in Haematology: Thrombocytes|Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||10^9/L||Standard Deviation|Mean
1305484|NCT02825251|Secondary|Change From Baseline in Haematology: Erythrocytes|Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||10^12/L||Standard Deviation|Mean
1305485|NCT02825251|Secondary|Change From Baseline in Haematology: Haematocrit|Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||% of haematocrit||Standard Deviation|Mean
1305486|NCT02825251|Secondary|Change From Baseline in Haematology: Haemoglobin|Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305487|NCT02825251|Secondary|Change From Screening in Fundus Photography/Fundoscopy|Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305488|NCT02825251|Secondary|Change From Screening in Electrocardiogram (ECG)|Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305489|NCT02825251|Secondary|Change From Baseline in Vital Sign: Pulse|Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Beats/minute||Standard Deviation|Mean
1305490|NCT02825251|Secondary|Change From Baseline in Vital Sign: Blood Pressure|Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmHg||Standard Deviation|Mean
1305491|NCT02825251|Secondary|Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck|Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305492|NCT02825251|Secondary|Change From Baseline in Physical Examination: Skin|Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305493|NCT02825251|Secondary|Change From Baseline in Physical Examination: Musculoskeletal System|Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305518|NCT02825251|Secondary|Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]|Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305494|NCT02825251|Secondary|Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth|Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305495|NCT02825251|Secondary|Change From Baseline in Physical Examination: Central and Peripheral Nervous System|Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305496|NCT02825251|Secondary|Change From Baseline in Physical Examination: Cardiovascular System|Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305497|NCT02825251|Secondary|Change From Baseline in Physical Examination: Respiratory System|Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
1305498|NCT02825251|Secondary|Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)|Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305499|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305500|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305501|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305502|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305503|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305504|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305602|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 5||Week 5|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305505|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305506|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 – Inclusive)|Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305507|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 – Inclusive)|Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
1305508|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall|"ADA classification of hypo:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG ≤3.9 mmol/L with symptoms.~Asymptomatic: PG ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG >3.9 mmol/L with symptoms.~Unclassifiable.~NN classification of hypo:~BG confirmed: PG <3.1 mmol/L with/without symptoms.~Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.~Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.~Unclassifiable.~Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo."|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis. The results are based on the on-treatment period.|||Number of hypoglycaemic episodes|||Number
1305509|NCT02825251|Secondary|Number of Treatment Emergent Infusion Site Reactions|Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of infusion site reaction events|||Number
1305510|NCT02825251|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of adverse events|||Number
1305511|NCT02825251|Secondary|Change From Baseline in IG Peak After Start of Meal|Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305512|NCT02825251|Secondary|Change From Baseline in Time to the IG Peak After Start of Meal|Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Minute||Standard Deviation|Mean
1305513|NCT02825251|Secondary|Change From Baseline in AUCIG,0-4h|Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305514|NCT02825251|Secondary|Change From Baseline in AUCIG,0-2h|Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305515|NCT02825251|Secondary|Change From Baseline in AUCIG,0-1h|Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305516|NCT02825251|Secondary|Change From Baseline in AUCIG,0-30min|Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305603|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305519|NCT02825251|Secondary|Variation in the IG Profile|Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Full Range|Median
1305520|NCT02825251|Secondary|Percentage of Time Spent Within IG Target Range 4.0–7.8 mmol/L (71–140 mg/dL) and 4.0-10 mmol/L (71–180 mg/dL)|Percentage of time spent within IG target range 4.0–7.8 mmol/L (71–140 mg/dL) and 4.0-10 mmol/L (71–180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of time||Standard Deviation|Mean
1305521|NCT02825251|Secondary|Change From Baseline in Mean of the IG Profile|Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305522|NCT02825251|Secondary|Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])|Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Number of Events|||Number
1305523|NCT02825251|Secondary|Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])|Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of time||Standard Deviation|Mean
1305524|NCT02825251|Secondary|Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305525|NCT02825251|Secondary|Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Minutes||Standard Deviation|Mean
1305526|NCT02825251|Secondary|Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305527|NCT02825251|Secondary|Insulin Delivery Pump Parameter: Active Insulin Time|Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Hour (h)||Standard Deviation|Mean
1305528|NCT02825251|Secondary|Insulin Delivery Pump Parameter: Glucose Sensitivity Factor|Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L/U||Standard Deviation|Mean
1305529|NCT02825251|Secondary|Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio|Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Gram (g)/U||Standard Deviation|Mean
1305530|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose|No data was collected for individual meal insulin dose.|Week 16|No subjects were analysed, as no data was collected for individual meal insulin dose.||||||
1305531|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Total Daily Insulin Dose|Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/Kg||Standard Deviation|Mean
1305532|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Total Bolus|Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/Kg||Standard Deviation|Mean
1305533|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Total Basal|Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/Kg||Standard Deviation|Mean
1305534|NCT02825251|Secondary|Insulin Dose in Units/Day: Individual Meal Insulin Dose|No data was collected for individual meal insulin dose.|Week 16|No subjects were analysed, as no data was collected for individual meal insulin dose.||||||
1305535|NCT02825251|Secondary|Insulin Dose in Units/Day: Total Daily Insulin Dose|Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U||Standard Deviation|Mean
1305536|NCT02825251|Secondary|Insulin Dose in Units/Day: Total Bolus|Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U||Standard Deviation|Mean
1305537|NCT02825251|Secondary|Insulin Dose in Units/Day: Total Basal|Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.|Week 16|The safety analysis set included all subjects receiving at least one dose of the investigational medicinal product (IMP, faster aspart) or its comparator (NovoRapid®/NovoLog®). Number analyzed = Number of subjects contributed to the analysis.|||Unit (U)||Standard Deviation|Mean
1305538|NCT02825251|Secondary|Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)|Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Full Range|Median
1305539|NCT02825251|Secondary|Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia|Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
1305540|NCT02825251|Secondary|Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]|Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
1305541|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements|Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305542|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile|Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Full Range|Median
1305543|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)|Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305544|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305545|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305546|NCT02825251|Secondary|Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile|Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305547|NCT02825251|Secondary|Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)|Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305548|NCT02825251|Secondary|Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)|Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305549|NCT02825251|Secondary|Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes|Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
1305550|NCT02825251|Secondary|Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)|Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
1305551|NCT02825251|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305552|NCT02825251|Secondary|Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM|Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L [70 mg/dL]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||min/day||Standard Deviation|Mean
1305553|NCT02825251|Secondary|Change From Baseline in 1,5-anhydroglucitol|Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||ug/mL||Standard Deviation|Mean
1305554|NCT02825251|Secondary|Change From Baseline in 1-hour PPG Increment|Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1305555|NCT02825251|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Percentage (%) of HbA1c||Standard Deviation|Mean
1305604|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 3||Week 3|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305557|NCT02824913|Secondary|Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M|Tear meniscus height of the inferior eyelid was measured by UHR-OCT and Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution|Pre-dose and up to six hours after dose|"One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).~Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported."||||||
1305558|NCT02824913|Secondary|Lower Tear Meniscus Height as Measured by the Keratograph 5M|Tear meniscus height of the inferior eyelid was measured with the Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution|Pre-dose and up to six hours after dose|"One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).~Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported."||||||
1305559|NCT02824913|Primary|Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo|Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution.|Pre-dose and up to six hours after dose|"One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).~Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported."||||||
1305560|NCT02823964|Primary|Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities|Descriptive analysis|12 months||||Participants|||Count of Participants
1305561|NCT02823600|Post-Hoc|Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera||Up to as much as one year after study enrollment|Diabetic dialysis participants|||Participants|||Count of Participants
1305562|NCT02823600|Secondary|Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population|Changes in eye exam rates of the diabetic subset of total population from baseline (i.e. study entry) and post-enrollment in study. Baseline data were to be obtained from the UNC electronic medical record (EMR) as the number of participants with eye exams within the past year and post data would consist of the number of participants completing a study exam.|Baseline and post retinal eye exam|Baseline retinal examination data were not present within the EMR; therefore, this analysis could not be performed.||||||
1305563|NCT02823600|Secondary|Participant Satisfaction|Participant satisfaction survey data to be collected following the completion of retinal eye exam. Participants will be assessed on participant satisfaction measures such as comfort of experience, recovery time, and time invested in undergoing procedure vs. traditional retinal exam methods. The survey utilized a five-point Likert scale with the following responses: (1) strongly agree, (2) agree, (3) neutral, (4) disagree, (5) strongly disagree. The outcome measure is reported percentages for each of the six survey components.|Post retinal eye exam|This analysis is based on responses from the 39 that completed the survey.|||Percentage of participants|||Number
1305564|NCT02823600|Secondary|Overall Retinopathy in a Dialysis Population|Number of participants found to have retinopathy in a dialysis population|Post retinal eye exam||||Participants|||Count of Participants
1305565|NCT02823600|Primary|Usability of the RetinaVue Hand-Held 100 Camera|Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.|baseline visit||||Retinal Images|Retinal Images||Count of Units
1305566|NCT02823431|Secondary|Visual Analog Scale Scores (Measure of Discomfort) After Catheterization|visual analog scales were performed to evaluate discomfort at specified time points during the urodynamic studies. The scale is 1-100mm, with higher numbers indicating greater discomfort.|duration of urodynamic study, 2 hours||||mm||Standard Deviation|Mean
1305567|NCT02823431|Secondary|Number of Participants With Interrupted Urinary Flow Pattern During Micturition|presence of interrupted flow during micturition|duration of urodynamic study, 2 hours||||Participants|||Count of Participants
1305568|NCT02823431|Secondary|Detrusor Pressure at Maximum Flow|bladder pressure reading (mmHg) during maximum flow during micturition|duration of urodynamic study, 2 hours||||cmH2O||Standard Deviation|Mean
1305569|NCT02823431|Primary|Voiding Efficiency|voided volume/{voided volume + residual volume} during micturition study during urodynamic studies|duration of urodynamic study, 2 hours||||Percent voiding efficiency||Standard Deviation|Mean
1305570|NCT02823080|Other Pre-specified|Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy|-severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6.|0-6 days||||GI manifestations|||Number
1305571|NCT02823080|Secondary|Daily Total Leucocytic Count|TLC(x 1ooo cells/ml)|0 -8days.||||1000 cells/ml||Standard Deviation|Mean
1305572|NCT02823080|Secondary|Ultrasound Detected Severity Grades of Ascites From Days 0-8|-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8.|0-8 days||||US detected ascitis|||Number
1305573|NCT02823080|Secondary|Daily Hematocrits Value|Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%)|0-8 days.||||percentge||Standard Deviation|Mean
1305574|NCT02823080|Secondary|Daily Numerical Pain Visual Analogue Scale Score|-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain .|8 days.||||units on a scale||Standard Deviation|Mean
1305575|NCT02823080|Primary|Daily Maximal Ovarian Diameter|MOD (maximal ovarian diameter in mm) were evaluated daily.|8 days||||mm||Standard Deviation|Mean
1305576|NCT02823080|Primary|Daily Serum E2 Levels|Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.|8 days||||picograms/ml||Standard Deviation|Mean
1305577|NCT02822885|Primary|Endometrial Thickness According to Histological Diagnosis|Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography|2 weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||millimeter||Standard Deviation|Mean
1305578|NCT02822885|Primary|Uterine Artery Pulsatility Index According to Histological Diagnosis|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|2 weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
1305579|NCT02822885|Primary|Uterine Artery Resistive Index According to Histological Diagnosis|The primary outcome measures is uterine artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
1305580|NCT02822885|Primary|Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis|The primary outcome measure is spiral artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity – end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
1305581|NCT02822885|Primary|Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
1305582|NCT02822794|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1305583|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305584|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 20||Baseline; Week 20|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305585|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 16||Baseline; Week 16|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305586|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305587|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 10||Baseline; Week 10|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305588|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305589|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305590|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 5||Baseline; Week 5|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305591|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305592|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 3||Baseline; Week 3|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305593|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305594|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1305595|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305596|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305597|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305598|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305599|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 10||Week 10|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305600|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1305607|NCT02822794|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1305608|NCT02822794|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1305609|NCT02822794|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1305610|NCT02822794|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1305611|NCT02822287|Secondary|Local Oral Tolerability|Local oral tolerability was assessed by performing oropharyngeal examination as follows: Results of oropharyngeal examination (Normal and abnormal); If abnormal, any signs of lesion on oral mucosa or irritation of oral mucosa.|Day 1 (at screening and end of study)|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Participants|||Number
1305612|NCT02822287|Secondary|Number of Participants With Overall Opinion of Oral Solution|Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.|1 hour post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Number of Participants|||Number
1305613|NCT02822287|Secondary|Number of Participants With Overall Opinion of Warming Sensation|Overall opinion of warming sensation was measured by scale: 9= Like extremely; 8= Like very much; 7= Like moderately; 6= Like slightly; 5= Neither like nor dislike; 4= Dislike slightly; 3= Dislike moderately; 2= Dislike very much; 1= Dislike extremely|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Number of Participants|||Number
1305614|NCT02822287|Secondary|Number of Participants With Acceptability of Warming Sensation|Acceptability of strength of warming sensation was measured by a scale: 5= Much too strong; 4=Too strong (too warming); 3= Just about right (pleasant warming); 2= Too weak (not warming enough); 1= Much too weak|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Number of Participants|||Number
1305615|NCT02822287|Primary|Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose|Warming Sensation Intensity was measured on 100 mm visual analogue scale (VAS), marked as “no warming sensation” on the left hand side (= 0 mm) and “strongest possible warming sensation” at the right hand side (=100 mm) at pre-dose.|Pre-dose and 60 sec post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Millimeters (mm)||Standard Deviation|Mean
1305616|NCT02822287|Primary|Duration of Warming Sensation|Duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset of warming sensation occurred within 10 minutes of dosing but had not ended by the end of 10 minutes following dosing, then the duration was censored at 10 minutes minus the time to onset|10 minutes post-dose|The safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint and safety analysis. Of the 57 subjects in the Safety Population, 53 reported an onset of a warming sensation within10 minutes after dosing.|||Minutes||Full Range|Median
1305617|NCT02822287|Primary|Onset of Warming Sensation|Onset and duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset had not occurred by 10 minutes then time to onset was censored at 10 minutes. 53 of the 57 participants had onset within 10 minutes after dosing.|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Minutes||Full Range|Median
1305618|NCT02821455|Secondary|Correlation Between Bispectral Index (BIS) and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation.|The significance of the correlation between BIS and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation.|10 minutes after start of one-lung ventilation|Data not collected due to insufficient use of Bispectral Index Monitors and temperature monitors by anaesthetists responsible for the study participants at the study site.||||||
1305619|NCT02821455|Primary|Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation|The significance of the correlation between blood and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation|10 minutes after start of one-lung ventilation||||Correlation coefficient|||Number
1305634|NCT02815644|Primary|Cmax for Linagliptin|Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|Pharmacokinetic Set (PKS): The PKS included all 22 randomised subjects who were documented to have taken at least 1 dose of trial medication under fed or fasted condition without having protocol deviation relevant to the evaluation of relative bioavailability and without experiencing emesis at or before 2 times median tmax.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1351303|NCT01780922|Primary|C-Reactive Protein (CRP) Concentrations in Plamsa||0, 2, 4, 8, 24 h||||ug/mL||Standard Error|Mean
1305620|NCT02821403|Secondary|Self-assessment of Lens Performance Through Questionnaire|"After each monthly wearing period (visits 3-5), the participants’ lens performance, night vision quality and sleep quality (total 13 questions) were assessed subjectively using a questionnaire (scoring from 1 [very unsatisfactory] to 5 [very satisfactory]).~At the end of the study, the participants were asked to choose their preferred lens type among the three pairs of lenses based on their subjective feeling of the best lens type (i.e., either clear lens, yellow tinted lens or blue-filtering coated lens).~To make it clear and simple, here we only present the data on the participants choice of their preferred lens type (i.e., simply choosing the best lens among clear lens, yellow tinted lens or blue-filtering coated lens)."|Every 1-month interval from the date of randomization, up to 3 months||||Participants|||Count of Participants
1305621|NCT02821403|Primary|Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test|"The Farnsworth Munsell 100 hue test (X-Rite, USA) was used to evaluate colour vision. Each of the four trays consisted of 21 movable caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score was calculated, as documented in the instruction manual, to quantify the accuracy of color discrimination.~There are no defined endpoints to the total error score range.~A lower score indicates improved color discrimination ability."|Every 1-month interval from the date of randomization, up to 3 months||||units on a scale||Standard Error|Mean
1305622|NCT02821403|Primary|Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart|"Contrast sensitivity was measured using the Mars contrast sensitivity letter chart (Mars Perceptrix, Chappaqua, NY). One out of three charts differing in the letter combinations was selected randomly in order to avoid memorization of the charts. The chart was placed at 50 cm with each letter subtended 2° visual angle. We followed the recording procedures as specified by the manufacturer: participants were instructed to read the letters from high to low contrasts and the test ended when two consecutive errors were made. The contrast sensitivity was scored as the log contrast sensitivity of the last correct letter minus 0.04 log unit for every prior error. The test was administered under normal (room illumination, 400 lux) and glare conditions. A brightness acuity tester set at its medium light intensity level (100 foot lamberts) simulated the glaring condition.~A higher mean indicates improved contrast sensitivity."|Every 1-month interval from the date of randomization, up to 3 months||||log contrast sensitivity score||Standard Error|Mean
1305623|NCT02818244|Primary|Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.|The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient and will also be depicted by Bland-Altman plots.|24 minutes||||Concordance Correlation Coefficient wECG||95% Confidence Interval|Mean
1305624|NCT02817763|Secondary|Modified Root Coverage Esthetic Score (MRES)|The MRES evaluated six variables: gingival margin (GM): 0 or 3 points; marginal tissue contour (MTC): 0 or 1 point; soft tissue texture (STT): 0 or 1 point; mucogingival junction alignment (MGJ): 0 or 1 point; gingival color (GC): 0 or 1 point; restoration/cervical lesion color (R/CLC): 0 points = color of restoration or uncovered cervical lesion does not match with tooth’s color; 3 points = good color integration. Thus, 10 points was a perfect score.|6 months||||units on a scale|photographs|Standard Deviation|Mean
1305625|NCT02817763|Primary|Percentage of Defect Coverage|Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.|6 months||||Gingival recessions|Gingival recessions||Count of Units
1305626|NCT02815735|Primary|Comfort During the Day|Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.|Days 3, 12, 26|Missing data from one participant.|||units on a scale||Standard Deviation|Mean
1305627|NCT02815735|Primary|Comfort|Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
1305628|NCT02815644|Secondary|AUC0-72 for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
1305629|NCT02815644|Secondary|AUC0-infinity for Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for empagliflozin.|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
1305630|NCT02815644|Secondary|AUC0-infinity for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
1305631|NCT02815644|Primary|AUC 0-tz for Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for empagliflozin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
1305632|NCT02815644|Primary|AUC 0-tz for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
1305633|NCT02815644|Primary|Cmax for Empagliflozin|Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1305635|NCT02815397|Secondary|Safety Profile With Addition of Metformin Evaluated by Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0|Describe the safety profile observed by measuring fasting glucose and anion gap weekly through cycle 6.|18 months|will not have this data as study closed prematurely.||||||
1305636|NCT02815397|Secondary|Effect of Metformin Overall Survival|Evaluation of the addition of metformin to standard induction therapy on 18 month overall survival|18 months|will not have this data as study closed prematurely.||||||
1305637|NCT02815397|Secondary|Effect of Metformin Overall Response Rate|Evaluation of the effect of the addition of metformin to induction chemotherapy on overall response rates|3 years|no data available as study closed before response could be determined||||||
1305638|NCT02815397|Primary|Evaluation of Impact of Metformin on 18 Month Progression-free Survival|Progression-free survival determined by CT scans at 18 months|18 month|will not have this data as study closed prematurely.||||||
1305639|NCT02814643|Secondary|Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12|To compare the change from baseline at Week 12 in mean ACQ-6 score between patients receiving benralizumab 30mg and patients receiving placebo. The ACQ-6 assesses asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short-acting β2 agonist use). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses to each question. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma, and a score >1.5 indicates not well controlled asthma|12 weeks|The full analysis set included all patients who were randomized and received any investigational product.|||Score on a scale||Full Range|Mean
1305640|NCT02814643|Secondary|Proportion of Patients Who Experience a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Microneutralization Antibody Titer From Week 8 to Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in microneutralization antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Participants||90% Confidence Interval|Number
1305641|NCT02814643|Secondary|Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12|To compare the geometric mean titers of microneutralization antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Antibody titer||Geometric Coefficient of Variation|Geometric Mean
1305642|NCT02814643|Secondary|Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12|"To compare the geometric mean fold rises in influenza strain-specific microneutralization antibody responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where x is the postdose microneutralization antibody titer fold rise from Week 8 and z is the natural logarithm."|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Fold change||Geometric Coefficient of Variation|Geometric Mean
1305643|NCT02814643|Secondary|Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥320-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Participants||90% Confidence Interval|Number
1305644|NCT02814643|Primary|Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥40-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Participants||90% Confidence Interval|Number
1305645|NCT02814643|Primary|Proportion of Patients Who Experienced a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Hemagglutination-inhibition Antibody Titer From Week 8 to Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in hemagglutination-inhibition antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Participants||90% Confidence Interval|Number
1305697|NCT02809833|Primary|Change in TJC From Baseline to Week 52|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
1305646|NCT02814643|Primary|Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12|To compare the geometric mean titers of hemagglutination-inhibition antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Antibody titer||Standard Error|Geometric Least Squares Mean
1305647|NCT02814643|Primary|Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12|"To compare the geometric mean fold rises in influenza strain-specific hemagglutination-inhibition responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where x is the postdose HAI antibody titer fold rise from Week 8 and z is the natural logarithm."|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received ≥1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or microneutralization antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Fold change||Standard Error|Geometric Least Squares Mean
1305648|NCT02814279|Secondary|Root Coverage Esthetic Score|The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. Thus, 10 points was a perfect score.|6 months||||units on a scale|photographs|Standard Deviation|Mean
1305649|NCT02814279|Primary|Percentage of Defect Coverage|Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.|6 months||||percentage of root coverage||Standard Deviation|Mean
1305650|NCT02814227|Secondary|Negative Predictive Value (NPV)|NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||negative predictive value|||Number
1305651|NCT02814227|Secondary|Positive Predictive Value (PPV)|PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||positive predictive value|||Number
1305652|NCT02814227|Secondary|Sensitivity|Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||percentage of true positives|||Number
1305653|NCT02814227|Primary|Specificity|Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||percentage of true negatives|||Number
1305654|NCT02813070|Primary|Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers|The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant's brain image and the participant’s clinical diagnosis by 5 Japanese readers, who classified each participant's images as either normal or abnormal (raised) Flutemetanol F 18 uptake.|Up to 90 minutes after IMP administration|Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.|||Participants|||Count of Participants
1305655|NCT02813070|Primary|Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers|The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant’s brain image and the participant’s clinical diagnosis by 5 non-Japanese readers, who classified each participant’s images as either normal or abnormal (raised) Flutemetanol F 18 uptake.|Up to 90 minutes after investigational medicinal product (IMP) administration|Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.|||Participants|||Count of Participants
1305656|NCT02811965|Primary|Peak Pressure Index on the Heel|Peak pressure index calculated by centering a 3 X 3 region of interest (14.52 cm^2) over maximum pressure sensor reading within the region of interest encompassing the heel.|5 minutes of pressure mapping||||mmHg||Standard Deviation|Mean
1305657|NCT02811965|Primary|Average Contact Force Exerted on the Heel|Average contact force calculated from an area of 40.32 cm^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping|5 minutes of pressure mapping||||mmHg||Standard Deviation|Mean
1305658|NCT02810873|Secondary|Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)|Optimal imaging time is the one (of the three) which will have least background activity in the surrounding tissue and image the maximum number of lesions with clarity. 95% confidence intervals will be used. To account for the multiplicity of lesions per patient, the GEE approach will be used, with the robust variance. Any adverse events will be summarized descriptively.|4 hours after Cu 64 TP3805 administered|No data were collected or reported as tumors were not extracted and histology could not be performed||||||
1305659|NCT02810873|Primary|Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog|Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient).|4 hours after Cu 64 TP3805 administered||||Number of Lesions|||Number
1317262|NCT02368314|Secondary|Frequency of Other AE SAE||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1305660|NCT02809911|Primary|Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). .|4 weeks|Includes subjects in the Initial Treatment Group (Those subjects treated with either Provant or Sham at the Enrollment Visit)|||Number of tests favoring arm/group|||Number
1305661|NCT02809911|Primary|Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored).|4 weeks|Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.|||Number of tests favoring arm/group|||Number
1305662|NCT02809833|Secondary|Percentage of Participants With AEs Considered Causally Related to Tocilizumab|"An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of tocilizumab. Worsened pre-existing conditions and laboratory or clinical tests that resulted in change or discontinuation of treatment were reported as AEs. The percentage of participants with treatment-related AEs (also known as adverse drug reactions) was reported as a separate endpoint and included both serious and non-serious AEs. Those AEs with a causal relationship reported as definite, probably, possible, or unlikely were considered to be related to tocilizumab. If the causal relationship was reported as unrelated, the AE was considered not related to tocilizumab treatment. Terms were reported verbatim as coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 12.0. The most common treatment-related AEs were reported, using those from the 10 highest incidence rate levels."|Baseline to end of treatment (up to 12 months)|All Enrolled Population|||percentage of participants|||Number
1305663|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 52.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305664|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 36.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305665|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 24.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305666|NCT02809833|Primary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 12.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305874|NCT02796092|Secondary|Improvement of Dysmenorrhea|Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dysmenorrhea|||participants|||Number
1317609|NCT02359305|Primary|Acetaminophen Dosage|One time in the OR prior to the start of surgery|Baseline||||mg/kg||Standard Deviation|Mean
1305667|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305668|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305669|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305670|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305671|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305672|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305673|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305674|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305675|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1311875|NCT02530281|Primary|Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4||From Baseline to Week 4|Participant|||mg/5 min||Inter-Quartile Range|Median
1305676|NCT02809833|Primary|Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305677|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 52|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 52 visit and the DAS28 change from Baseline to Week 52. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305678|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 36|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 36 visit and the DAS28 change from Baseline to Week 36. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305679|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 24|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 24 visit and the DAS28 change from Baseline to Week 24. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305680|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 12|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 12 visit and the DAS28 change from Baseline to Week 12. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305681|NCT02809833|Primary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 4 visit and the DAS28 change from Baseline to Week 4. Participants with a score less than or equal to (≤) 3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305682|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305683|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305684|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1317610|NCT02359110|Secondary|Total Morphine Consumption||12 hours post-operatively||||mg||Standard Deviation|Mean
1305685|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305686|NCT02809833|Primary|VAS Score of Physician-Assessed Disease Activity at Baseline|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305687|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305688|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305689|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305690|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305691|NCT02809833|Primary|VAS Score of Participant-Assessed Disease Activity at Baseline|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
1305692|NCT02809833|Primary|Change in SJC From Baseline to Week 52|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
1305693|NCT02809833|Primary|Change in SJC From Baseline to Week 36|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
1305694|NCT02809833|Primary|Change in SJC From Baseline to Week 24|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
1305695|NCT02809833|Primary|Change in SJC From Baseline to Week 12|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
1305696|NCT02809833|Primary|SJC at Baseline|A total of 28 joints were assessed for swollenness. The number of swollen joints at Baseline was reported and could range from 0 to 28, where higher values represented more swollen joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
1305698|NCT02809833|Primary|Change in TJC From Baseline to Week 36|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
1305699|NCT02809833|Primary|Change in TJC From Baseline to Week 24|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
1305700|NCT02809833|Primary|Change in TJC From Baseline to Week 12|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
1305701|NCT02809833|Primary|TJC at Baseline|A total of 28 joints were assessed for tenderness. The number of tender joints at Baseline was reported and could range from 0 to 28, where higher values represented more tender joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
1305702|NCT02809833|Primary|Change in DAS28 From Baseline to Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305703|NCT02809833|Primary|Change in DAS28 From Baseline to Week 48|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 48 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305704|NCT02809833|Primary|Change in DAS28 From Baseline to Week 44|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 44 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305705|NCT02809833|Primary|Change in DAS28 From Baseline to Week 40|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 40 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305706|NCT02809833|Primary|Change in DAS28 From Baseline to Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305707|NCT02809833|Primary|Change in DAS28 From Baseline to Week 32|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 32 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1309240|NCT02614222|Secondary|Number of Patients That Needed Rescue Opioids||During hospital stay (maximum 3 days)|This data was not collected for 4 (out of 27) patients|||Participants|||Count of Participants
1305708|NCT02809833|Primary|Change in DAS28 From Baseline to Week 28|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 28 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305709|NCT02809833|Primary|Change in DAS28 From Baseline to Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305710|NCT02809833|Primary|Change in DAS28 From Baseline to Week 20|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 20 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305711|NCT02809833|Primary|Change in DAS28 From Baseline to Week 16|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 16 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305712|NCT02809833|Primary|Change in DAS28 From Baseline to Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305713|NCT02809833|Primary|Change in DAS28 From Baseline to Week 8|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 8 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305714|NCT02809833|Primary|Change in DAS28 From Baseline to Week 4|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 4 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305715|NCT02809833|Primary|28-Joint Disease Activity Score (DAS28) at Baseline|The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
1305748|NCT02805907|Secondary|Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)|Mini-AQLQ (Asthma Quality of Life Questionnaire): The response options for each item are placed on an equidistant 7-point scale, where 1 = maximum limitation and 7 = no limitation. The questionnaire Global score, which is the mean for all 15 items that make up the scale, and a score for each dimension, which is the average of the corresponding items for that dimension.|6 months||||units on a scale||Standard Deviation|Mean
1305716|NCT02809833|Primary|Percentage of Participants With Tocilizumab Dose Adjustments by Reason|"The percentage of participants with any tocilizumab dose adjustment during the study was reported among all reasons given for tocilizumab dose adjustments, as provided in the CRF. The sum of all reasons may add up to >100 percent (%) because more than one reason could be given for each dose change. In the table presented, Other Reasons refers to any reason other than those specified in categories. Similarly, Other Laboratory Change refers to a change in any laboratory parameter other than those specified in categories."|Baseline to end of treatment (up to 12 months)|"All Enrolled Population. The Number of Participants Analyzed reflects the number of participants who had at least one tocilizumab dose adjustment during the study."|||percentage of participants|||Number
1305717|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 52."|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305718|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 48."|Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305719|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 44."|Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305720|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 40."|Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305721|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 36."|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305806|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT.|12 weeks after the first PDT|ITT|||percentage of change from baseline||Standard Deviation|Mean
1320145|NCT02295020|Primary|Oxford Knee Score||Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.||||||
1305722|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 32."|Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305723|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 28."|Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305724|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 24."|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305725|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 20."|Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305726|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 16."|Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305727|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 12."|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1325488|NCT02181127|Secondary|• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise||2 weeks|||||||
1305728|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 8."|Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305729|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values greater than (>) 1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC less than (<) 0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 4."|Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
1305730|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 52|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 52 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305731|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 24|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 24 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
1305732|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Baseline|SmPC recommendations were specified in the collection of routine laboratory samples for alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), absolute neutrophil count (ANC), and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific upper limit of normal (ULN). Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells per liter (cells/L) for ANC and 50 to 100 × 10^3 cells per microliter (cells/μL) for platelet count. The percentage of participants with greater than or equal to (≥) 1 documented/evaluable laboratory value at Baseline was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Baseline|All Enrolled Population.|||percentage of participants|||Number
1305733|NCT02808130|Primary|Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status|Contrary to oxidant mediators, TAOC provides an extensive overview of the antioxidant status of the individuals and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of TAOC can provide a more accurate and extensive assessment of antioxidant status rather than the separate measurement of individual antioxidant molecules|8-10 am on the day following periodontal status assessment.||||pg/ml||Standard Error|Mean
1305734|NCT02808130|Primary|Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation|Protein carbonylation is another nonenzymatic oxidative post-translational modification and assesed by protein carbonyl tissue content that is often used as a biomarker of oxidative stress.|8-10 am on the day following periodontal status assessment.||||pg/ml||Standard Error|Mean
1305735|NCT02808130|Primary|Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.|Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipid. Malondialdehyde (MDA) is the most specific and the most often used molecule in the measurement of biological lipid oxidation|8-10 am on the day following periodontal status assessment.||||pg/ml||Standard Error|Mean
1305807|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT)|Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT|||percentage of change from baseline||Standard Deviation|Mean
1312569|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||mmHg||Standard Deviation|Mean
1305736|NCT02806869|Secondary|Average Area Under the Plasma Concentration-time Curve (AUC) in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen|The plasma concentration of ibuprofen was measured at multiple timepoints over a 24 hour period. The reported value represents the mean and standard deviation of AUC over this time frame.|from time 0 to 24 hours|Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.|||h*mg/L||Standard Deviation|Mean
1305737|NCT02806869|Secondary|Maximum Duodenal Fluid Concentration of Ibuprofen in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen|The concentration of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation maximum concentration measured in duodenal fluid.|from time 0 to 7 hours|Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.|||mg/L||Standard Deviation|Mean
1305738|NCT02806869|Primary|Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen|The pH of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation of duodenal fluid pH.|from time 0 to 7 hours|Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.|||pH||Standard Deviation|Mean
1305739|NCT02806544|Secondary|Breast Conserving Therapy|"The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)."|4-6 months|This outcome measure was analyzed in patients who were treated with 4 months of neoadjuvant tamoxifen|||participants|||Number
1305740|NCT02806544|Secondary|Pathologic Complete Response|Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.|4-6 months|This Outcome Measure was only assessed among patients who had undergone surgery.|||participants|||Number
1305741|NCT02806544|Secondary|Overall Clinical Response Rate|Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.|4-6 months|This Outcome Measure was only assessed among patients undergoing surgery and is a unique outcome measure.|||participants|||Number
1305742|NCT02806544|Secondary|Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy|Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.|4-6 weeks|32 of the 35 patients underwent an on-treatment biopsy; 3 patients did not follow-up and were not included in the number of participants analyzed for this measure.|||participants|||Number
1305743|NCT02806544|Secondary|Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen|"Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)"|4-6 months||||participants|||Number
1305744|NCT02806544|Primary|Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility|Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.|4-6 months|The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study.|||participants|||Number
1305745|NCT02806505|Secondary|Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24|Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.|Weeks 12 and 24|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1305746|NCT02806505|Secondary|Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)|Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.|EOT (Week 48)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1305747|NCT02806505|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment|SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.|24 weeks after end of treatment (Week 72)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1325489|NCT02181127|Secondary|Mean BG During Exercise||2 weeks|||||||
1305749|NCT02805907|Secondary|Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)|"Dose inhaled corticosteroids as the scale of the Spanish guide for asthma management (GEMA 4.0): Depends on the type of steroids:~Beclomethasone dipropionate (Low dose: 200-500 mcg/day, Half dose: 501-1000 mcg/day, High dose: 1001-2000 mcg/day), Beclomethasone extrafine (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: > 400 mcg/day), Budesonide (Low dose: 200-400 mcg/day, Half dose: 401-800 mcg/day, High dose: 801-1600 mcg/day), Ciclesonide (Low dose: 80-160 mcg/day, Half dose: 161-320 mcg/day, High dose: 321-1280 mcg/day), Fluticasone furoate (Half dose: 92 mcg/day, High dose: 184 mcg/day), Fluticasone propionate (Low dose: 100-250 mcg/day, Half dose: 251-500 mcg/day, High dose: 501-1000 mcg/day), Mometasone furoate (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: 401-800 mcg/day),"|6 months||||Participants|||Count of Participants
1305750|NCT02805907|Secondary|Number of Asthma Exacerbations|Number of asthma exacerbations during the study period|6 months||||Asthma exacerbations||Standard Deviation|Mean
1305751|NCT02805907|Primary|Asthma Control Measured With Asthma Control Test (ACT)|Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.|6 months||||units on a scale||Standard Deviation|Mean
1305752|NCT02802878|Secondary|Change in 5-chair Stand Time|The chair stand test is a validated measure of physical performance in adults with knee osteoarthritis. Participants were instructed to stand from a chair (seat height 44.45 cm) 5 times as quickly as they could without using their arms. Two trials were timed and averaged.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||seconds||Standard Deviation|Mean
1305753|NCT02802878|Secondary|Change in 20-meter Walk Time|A timed 20-meter walk was completed as a measure of lower limb physical performance. Participants were instructed to walk along a 20-meters straight, uninterrupted course as quickly as they could. Timing started when the participant initiated foot movement and stopped when both feet crossed the 20-meter mark. Times for two trials were recorded and the averaged.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||seconds||Standard Deviation|Mean
1305754|NCT02802878|Secondary|Change in Knee Pain Assessed by a Knee Injury and Osteoarthritis Outcome Score|The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale was used at baseline and follow-up to assess participant outcomes. The pain subscale is made up of 9 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||units on a scale||Standard Deviation|Mean
1305755|NCT02802878|Secondary|Change in Maximal Isokinetic Knee Flexor Torque by Body Mass Assessed by Isokinetic Dynamometer.|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee flexor torque, using an isokinetic dynamometer.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||Newton-meters/kilogram||Standard Error|Least Squares Mean
1305756|NCT02802878|Primary|Change in Maximal Isokinetic Knee Extensor Torque by Body Mass Assessed by Isokinetic Dynamometer.|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque at 60°/sec, using an isokinetic dynamometer. These testing procedures will then be repeated for the other side.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||Newton-meters/kilogram||Standard Error|Least Squares Mean
1305757|NCT02802592|Secondary|Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey||assessed at 1-week, 1-month, and 3-months from date of surgery|||||||
1305758|NCT02802592|Secondary|Overall Hospitalization Cost||up to one year from date of surgery|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure as any data collected was not unblinded to the study team nor was it analyzed.||||||
1305759|NCT02802592|Secondary|Length of Stay (# of Total Days Hospitalized)||up to one year from date of surgery|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure as any data collected was not unblinded to the study team nor was it analyzed.||||||
1305760|NCT02802592|Primary|Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period||Start of surgery to 96 hours post op|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure as any data collected was not unblinded to the study team nor was it analyzed.||||||
1305761|NCT02802449|Secondary|Oxidative Stress Markers: Isoprostane||Baseline and Week 6||||pg/ml||Standard Deviation|Mean
1305762|NCT02802449|Secondary|Oxidative Stress Markers: GSH||Baseline and Week 6||||umol/L||Standard Deviation|Mean
1305763|NCT02802449|Secondary|Oxidative Stress Markers: Homocysteine||Baseline and Week 6||||umol/L||Standard Deviation|Mean
1305764|NCT02802449|Secondary|Oxidative Stress Markers: Cysteine||Baseline and Week 6||||umol/L||Standard Deviation|Mean
1305765|NCT02802449|Primary|Vitamin D3 Level||Baseline and Week 6||||ng/ml||Standard Deviation|Mean
1353050|NCT01758900|Secondary|Complication Rate||Within 1 week after all the examinations are finished||||participants|||Number
1305766|NCT02802449|Primary|Plasma PTH Level|Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either ‘nutrient-responsive’ or ‘nutrient-resistant’. These studies should help identify the ‘clinical’ characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation.|Baseline and Week 6||||pg/ml||Standard Deviation|Mean
1305767|NCT02801396|Primary|Percentage of Eyes With Acceptable Cosmetic Lens Fit|Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||Percentage of eyes|Eyes||Number
1305768|NCT02801396|Primary|Percentage of Eyes With Acceptable Mechanical Lens Fit|Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||Percentage of eyes|Eyes||Number
1305769|NCT02801396|Primary|Visual Performance (LogMar)|Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Eyes|Standard Deviation|Mean
1305770|NCT02801396|Primary|CLUE Handling|CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
1305771|NCT02801006|Primary|Overall Satisfaction|Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1305772|NCT02801006|Primary|Lens Handling|Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1305773|NCT02801006|Primary|Stability of Vision|Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1305774|NCT02801006|Primary|Clarity of Vision|Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1305775|NCT02801006|Primary|Dryness|Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1305776|NCT02801006|Primary|Comfort|Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1305777|NCT02800213|Primary|Received Tidal Volume|Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.|3 minutes||||milliliters||95% Confidence Interval|Mean
1305778|NCT02799784|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at Week 8|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as 23 and 24 hour post-dose FEV1 measurements. All par. in the Intent To Treat (ITT) Population who were not identified as full protocol deviators were included in Per-Protocol (PP) Population. ITT Population, comprised of all randomized subjects, who received at least one dose of study medication.|Week 8|Per Protocol Population|||Liters||Standard Error|Least Squares Mean
1305779|NCT02799082|Secondary|Related Adverse Events /AEs)|Related treatment-emerged-adverse events (TEAEs) until 12 weeks after the last PDT (>=5%) TEAEs were reported from the day of the 1st PDT until the end-of-study (clinical part), i.e. 12 weeks after the last PDT (until 12 weeks after the 1st PDT or up to 24 weeks in case a 2nd PDT was applied).|up to 24 weeks after the 1st PDT|safety population|||Participants|||Count of Participants
1305780|NCT02799082|Secondary|Discomfort During and After PDT|Local discomfort experienced by the patient after illumination were documented in three categories: itching, burning, pain.|during and after PDT [3h - 4 h]|Safety Population (Overall reactions after first and/or second PDT)|||Participants|||Count of Participants
1305781|NCT02799082|Secondary|Local Skin Reactions|Local skin reactions observed immediately after illumination by the investigator were documented using different categories (erythema, edema, induration, vesicles, erosion, ulceration, scaling/flanking, scabbing/crusting,weeping/exudates).|during and after PDT [3h - 4 h]|Safety Population, Overall reactions after first and/or second PDT|||Participants|||Count of Participants
1305853|NCT02796963|Secondary|Number of Men Reporting Condomless Sex at 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305782|NCT02799082|Secondary|Overall Cosmetic Outcome 12 Weeks After the Last PDT|Overall Cosmetic Outcome (CO) 12 weeks after PDT (12 weeks after 1st PDT or 12 weeks after 2nd PDT). The cosmetic outcome at the end-of-study visit was calculated on the basis of skin quality assessment: skin surface, hyperpigmentation, hypopigmentation, mottled/irregular pigmentation, degree of scarring, and atrophy. The CO was rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; the CO was rated as good if the sum score at a given visit has improved by at least 1 point as compared to baseline; the cosmetic outcome is rated as satisfactory if the sum score at a given visit is identical to the one at baseline; the cosmetic outcome is rated as unsatisfactory if the sum score at a given visit has worsened by 1 point compared to baseline, the cosmetic outcome is rated as impaired if the sum score at a given visit has worsened by at least 2 points compared to baseline.|12 weeks after the last PDT, up to 24 weeks|FAS|||Participants|||Count of Participants
1305783|NCT02799082|Secondary|Subjects With Partial Clearance 12 Weeks After the Last PDT|Percentage of subjects with clearance of at least 75% of lesions 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last PDT, up to 24 weeks|FAS|||percentage of patients||95% Confidence Interval|Number
1305784|NCT02799082|Secondary|Subjects With Complete Clearance 12 Weeks After the First PDT|AK clearance rate, defined as the number of subjects with complete remission of all AK lesions assessed at 12 weeks after the first PDT|12 weeks after the first PDT|FAS|||percentage of patients||95% Confidence Interval|Number
1305785|NCT02799082|Secondary|Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)|"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.~Subgroup Analysis for patients with lesions located in the scalp only."|12 weeks after the last PDT, up to 24 weeks|FAS|||mm²||Standard Deviation|Mean
1305786|NCT02799082|Secondary|Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)|"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.~Subgroup Analysis for patients with lesions located in the face only."|12 weeks after the last PDT, up to 24 weeks|FAS|||mm²||Standard Deviation|Mean
1305787|NCT02799082|Secondary|Change in Total Lesion Size 12 Weeks After the Last PDT|"Change in the mean total lesion area 12 weeks per subject after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline."|12 weeks after the last PDT, up to 24 weeks|FAS (Overall)|||mm²||Standard Deviation|Mean
1305788|NCT02799082|Secondary|Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT|"Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~for subgroup analysis: patients treated with narrow spectrum lamp only."|12 weeks after the last PDT, up to 24 weeks|FAS, subgroup: lesions treated with narrow spectrum lamp only|||percentage of lesions|lesions -PDT with narrow spectrum lamp|95% Confidence Interval|Number
1305789|NCT02799082|Secondary|Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT|Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment); Overall population|12 weeks after the last PDT, up to 24 weeks|FAS (Overall)|||percentage of lesions|individual lesions|95% Confidence Interval|Number
1305790|NCT02799082|Primary|Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)|"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~Analysis was for the subgroup: treated by narrow spectrum lamps only [n=13 (vehicle), n= 28 (BF-200 ALA)]"|12 weeks after the last PDT, up to 24 weeks|PPP; subgroup analysis for patients only treated with narrow spectrum lamps|||percentage of patients||95% Confidence Interval|Number
1305791|NCT02799082|Primary|Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)|"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~Analysis was for the subgroup: treated by narrow spectrum lamps only [n=15 (vehicle), n= 31 (BF-200 ALA)]"|12 weeks after the last PDT, up to 24 weeks|FAS; subgroup analysis for patients only treated with narrow spectrum lamps|||percentage of participants||95% Confidence Interval|Number
1305792|NCT02799082|Primary|Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)|AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last PDT, up to 24 weeks|per protocol population (PPP), (Overall)|||percentage of participants||95% Confidence Interval|Number
1305793|NCT02799082|Primary|Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)|AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last photodynamic therapy (PDT), up to 24 weeks|Full analysis set (FAS), Overall|||percentage of participants||95% Confidence Interval|Number
1305875|NCT02796092|Secondary|Improvement of Urinary Urgency|Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment urinary urgency|||participants|||Number
1305794|NCT02799069|Secondary|Adverse Reactions|"Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of >=5%.~TEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy.~The safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment."|up to 12 weeks after the last PDT, up to 24 weeks after first treatment|safety population|||Participants|||Count of Participants
1305795|NCT02799069|Secondary|Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|"Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT.~Only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)"|during PDT treatment [3 h - 4 h ]|Safety Population|||units on a scale||Standard Deviation|Mean
1305796|NCT02799069|Secondary|Local Discomfort - Pain During First Photodynamic Therapy (PDT-1)|Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT.|during PDT treatment [3 h - 4 h ]|Safety Population|||units on a scale||Standard Deviation|Mean
1305797|NCT02799069|Secondary|Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)|during PDT treatment [3 h - 4 h ]|Safety Population - retreated subjects only|||percentage of patients|||Number
1305798|NCT02799069|Secondary|Local Discomfort During First Photodynamic Therapy (PDT-1)|Local discomfort reported by the patients during Illumination of first PDT (PDT1)|during PDT treatment [3 h - 4 h ]|Safety Population|||percentage of patients|||Number
1305799|NCT02799069|Secondary|Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data).|during PDT treatment [3 h - 4 h ]|Safety Population - retreated subjects only|||percentage of patients|||Number
1305800|NCT02799069|Secondary|Local Skin Reactions During First Photodynamic Therapy (PDT-1)|Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1)|during PDT treatment [3 h - 4 h ]|Safety Population|||percentage of patients|||Number
1305801|NCT02799069|Secondary|Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline|The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline.|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305802|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT).|12 weeks after the last PDT, up to 24 weeks after the first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
1305803|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
1305804|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT.|12 weeks after the second PDT, 24 after first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
1305805|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
1309298|NCT02613871|Secondary|Percentage of Participants That Required HBV Therapy During Treatment and up to Posttreatment Week 12||Up to Posttreatment Week 12|Full Analysis Set|||Percentage of participants|||Number
1305808|NCT02799069|Secondary|Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only|"Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT.~Lesions were illuminated during photodynamic therapy with narrow spectrum devices only (~630 nm)."|up to 12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of lesions|lesions treated with narrow spectrum|95% Confidence Interval|Number
1305809|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT)|Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT).|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of lesions|num,ber of individual lesions|95% Confidence Interval|Number
1305810|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT)|Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after first treatment|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
1305811|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After Second PDT|Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT.|12 weeks after the second PDT, 24 weeks after first treatment|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
1305812|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of lesions|number of individiual lesions|95% Confidence Interval|Number
1305813|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT).|12 weeks after the first PDT|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
1305814|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT)|3-4 weeks after the first PDT|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
1305815|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT.~The outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) ."|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305816|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT.~The outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT)."|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305817|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT.~A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT."|12 weeks after the second PDT, 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305818|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT.~A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT."|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305819|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT)|A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT.|12 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
1305820|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT)|A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
1305821|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)|A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305822|NCT02799069|Secondary|Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.|12 weeks after the second PDT, 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305823|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305824|NCT02799069|Secondary|Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT.|12 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
1305825|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
1305826|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only|"Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (~630 nm).~An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
1305827|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP|"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|per protocol set (PP)|||percentage of patients||95% Confidence Interval|Number
1305828|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT|"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|Intent-to-treat (ITT)|||percentage of patients||95% Confidence Interval|Number
1305829|NCT02798289|Primary|Tear Meniscus Height Captured by Optical Coherence Tomography|Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.|Day 1|Safety population included all subjects who received device intervention.|||µm||Standard Deviation|Mean
1305830|NCT02797821|Secondary|Change In Plasma PLP From Baseline To Pre-3rd Dose At Week 9|Plasma PLP was quantified using liquid chromatography/mass spectrometry. Baseline plasma PLP values were calculated by averaging the pre-dose PLP values from blood samples collected during the Run-in Period at -168, -156, -24, -12, and 0 hours before Baseline. Week 9 PLP values were calculated using blood samples collected before the administration of the 3rd dose. The analysis was a REML-based repeated measures mixed model with treatment, visit, sex, Baseline PPi, Baseline weight group (≥ median versus < median) and study drug lot assignment as factors, and an unstructured covariance structure for within-participant correlation.|Baseline to Week 9|FAS: randomized participants who received ≥1 dose of study drug and had ≥1 pretreatment and ≥1 on-treatment PPi result.|||ng/mL||Standard Error|Least Squares Mean
1305831|NCT02797821|Primary|Change In Plasma PPi From Baseline To Pre-3rd Dose At Week 9|"Plasma PPi concentrations were determined using a specific enzyme-catalyzed reaction with a radiolabelled marker in a 3-step process. Baseline plasma PPi values were calculated by averaging pre-dose values from samples collected during the Run-in Period at -168, -156, -24, -12, and 0 hours before Baseline. Week 9 plasma PPi values were calculated using blood samples collected before administration of the 3rd dose. The analysis was a restricted maximum likelihood (REML)-based repeated measures mixed model with treatment, visit, sex, Baseline PPi, Baseline weight group (≥ median versus < median), and study drug lot assignment as factors, and an unstructured covariance structure for within-participant correlation.~Per inclusion criteria, participants had to have had a Screening PPi concentration of ≥3.9 micromolar (μM). Three participants (1 in each group) had Screening PPi concentrations of ≥3.9 μM, but Baseline PPi values ranged between 3.5 to 3.8 μM."|Baseline to Week 9|FAS: randomized participants who received ≥1 dose of study drug and had ≥1 pretreatment and ≥1 on-treatment PPi result.|||μM||Standard Error|Least Squares Mean
1305854|NCT02796963|Secondary|Cost of Developing and Implementing the Entire HIV Test Promotion Intervention, in United States Dollars (USD) Per Person Tested for HIV in the Last Six Months|Analysis of costs in USD associated with all aspects of the respective interventions per person tested for HIV in the last six months (human personnel, office space, pamphlets and flyers, social media promotion, in-person events, and all related costs associated with each intervention).|Six months after implementation of the crowdsourced intervention||2019-03-31|03/2019||||
1305855|NCT02796963|Primary|Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months|This will be assessed by self-report during a follow-up survey|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305832|NCT02797080|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the investigational product. A TEAE is any adverse change from the subject’s baseline condition, including any laboratory test value abnormality judged as clinically significant by the investigator, that occurs on or after the date of the first dose of study drug administered at home and throughout the duration of the clinical study, whether the adverse event is considered related to the treatment or not. A serious AE (SAE) is an AE that results in death, is life-threatening, results in persistent or significant disability or incapacity, inpatient hospitalization or prolongation of an existing hospitalization, is a congenital anomaly or birth defect, or other medically important event.|Baseline/Day 1 (Week 28 Follow-Up Visit for Study HZNP-ACT-302 ([NCT02593773]) through end of study; mean (SD) duration of treatment was 99.2 (58.48) days.|Safety Population, defined as all participants who received at least 1 dose of study drug after the Baseline Visit for Study HZNP-ACT-303.|||participants|||Number
1305833|NCT02797054|Primary|Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up||2 Months||||"Percent who responded Yes"|||Number
1305834|NCT02797054|Primary|Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up||2 Months||||"Percent who responded Yes"|||Number
1305835|NCT02797054|Primary|Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up||2 Months||||"Percent who responded Yes"|||Number
1305836|NCT02797054|Primary|Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up||2 Months||||"Percent who responded Yes"|||Number
1305837|NCT02797054|Primary|Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention||1 day||||"Percent who responded Yes"|||Number
1305838|NCT02797054|Primary|Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention||1 day||||"Percent who responded Yes"|||Number
1305839|NCT02797054|Primary|Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention||1 day||||"Percent who responded Yes"|||Number
1305840|NCT02797054|Primary|Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention||1 day||||"Percent who responded Yes"|||Number
1305841|NCT02796963|Secondary|Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305842|NCT02796963|Secondary|Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing|Frequency of men, defined as the number of men who reported using mobile apps in the past three months to give or receive information about HIV testing comparing their pre-intervention and post-intervention engagement|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305843|NCT02796963|Secondary|Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305844|NCT02796963|Secondary|Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305845|NCT02796963|Secondary|Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305846|NCT02796963|Secondary|Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305847|NCT02796963|Secondary|Mean Score of Anticipated HIV Stigma|Measured by a 7-item version of the anticipated HIV stigma scale, designed to measure the extent to which participants anticipated negative intrapersonal and interpersonal consequences were they to contract HIV in the future. All seven items were rated on a Likert-type scale (1=Strongly Disagree; 4=Strongly Agree). The mean score is reported, ranged from 1 to 4. Higher values indicate greater anticipated stigma.|From implementation roll-out to three months after implementation of crowdsourced intervention||||Scores on a scale||Standard Deviation|Mean
1305848|NCT02796963|Secondary|Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305849|NCT02796963|Secondary|Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305850|NCT02796963|Secondary|Community Engagement/ MSM Community Affiliation|Number of men, defined as an increase in closer affiliation with the MSM community (i.e., tongzhi circle, gay online networks or groups) when comparing their pre-intervention and post-intervention periods.|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305851|NCT02796963|Secondary|Change in HIV Testing Self-efficacy|Number of men who report higher levels of self-efficacy when comparing their pre-intervention and post-intervention HIV testing norms|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305852|NCT02796963|Secondary|HIV Testing Social Norms|HIV testing social norms will be measured using six survey items that are each on a five-point Likert scale. Increased HIV testing social norms will be defined as having an increase from baseline in any two of these six survey items and dichotomized accordingly. Number of men who report higher score of social norms when comparing their pre-intervention and post-intervention values|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
1305856|NCT02796651|Secondary|Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment|"To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value.~Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation."|At baseline and Day 7|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre||95% Confidence Interval|Least Squares Mean
1305857|NCT02796651|Secondary|Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment|To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation|Day 7: zero time to 6 hours post-dose|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre/Hour||95% Confidence Interval|Least Squares Mean
1305858|NCT02796651|Secondary|Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment|To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.|Day 1: zero time to 6 hours post-dose|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre/Hour||95% Confidence Interval|Least Squares Mean
1305859|NCT02796651|Primary|Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment|"To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg).~Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them.~Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation."|Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre/Hour||95% Confidence Interval|Least Squares Mean
1305860|NCT02796352|Secondary|HD IL2 Levels|Levels of HD IL2 biomarker in the blood of patients that received at least course 1 of therapy, and have had their disease re-evaluated will be considered evaluable for response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) version 1.1|Up to 21 months|No data displayed because data were not collected for this Outcome Measure, thus zero total participants analyzed.||||||
1305861|NCT02796352|Secondary|Overall Survival (OS)|Number of months from start of protocol therapy until death from any cause.|Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)||||months|||Number
1305862|NCT02796352|Secondary|Progression Free Survival (PFS)|Number of months of survival without disease progression from start of protocol therapy until objective tumor progression or death, per RECIST v1.1|Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)||||months|||Number
1305863|NCT02796352|Primary|Response Rate|Percentage of complete responses (CR) plus partial responses (PR), based upon Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1|Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled (21 months)||||Participants|||Count of Participants
1305864|NCT02796092|Secondary|Need for Re-embolization|Scheduled re-embolization due to incomplete occlusion|12 months||||participants|||Number
1305865|NCT02796092|Secondary|Complications|Toral number of events related to the procedure in the follow-up (1 year)|12 months||||events|||Number
1305866|NCT02796092|Secondary|Complications|Total number of events during the procedure|intraoperative||||minor events|||Number
1305867|NCT02796092|Secondary|Procedure Radiation Dose (AK)|AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment|Intraoperative||||mGy||Standard Deviation|Mean
1305868|NCT02796092|Secondary|Procedure Radiation Dose (DAP)|DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment|Intraoperative||||mGy*cm^2||Standard Deviation|Mean
1305869|NCT02796092|Secondary|Fluoroscopy Time|Total fluoroscopy time, recorded by the equipment (in minutes)|Intraoperative||||minutes||Standard Deviation|Mean
1305870|NCT02796092|Secondary|Total Intervention Duration|Total time length of the procedure, from puncture to compression (in minutes)|Intraoperative||||minutes||Standard Deviation|Mean
1305871|NCT02796092|Secondary|Cost of Treatment|Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.|Intraoperative||||US Dollars||Standard Deviation|Mean
1305872|NCT02796092|Secondary|Number of Devices Used|Number of coils and number of vascular plugs used in each procedure|intraoperative||||devices||Standard Deviation|Mean
1305873|NCT02796092|Secondary|Satisfaction With the Procedure|"Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9).~Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem."|12 months||||units on a scale||Standard Deviation|Mean
1305876|NCT02796092|Secondary|Improvement of Dyspareunia|Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dyspareunia|||participants|||Number
1305877|NCT02796092|Primary|Change in Pain Scale|"Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9).~VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)"|12 months|Population presenting pre-treatment pain (more than 1 in VAS)|||participants|||Number
1305878|NCT02794974|Secondary|Side Effects|frequency of side effects: dysphagia|intraoperatively||||participants|||Number
1305879|NCT02794974|Secondary|Side Effects|frequency of side effects: cough|intraoperatively||||participants|||Number
1305880|NCT02794974|Secondary|Side Effects|frequency of side effects: hoarseness|intraoperatively||||participants|||Number
1305881|NCT02794974|Primary|Supplementation of Prilocaine 1% by the Surgeon (Volume)|volume of prilocaine 1% supplemented by the surgeon (ml)|intraoperatively||||ml||Standard Deviation|Mean
1305882|NCT02794974|Primary|Supplementation of Prilocaine 1% by the Surgeon (Frequency)|number of participants who need supplementation of prilocaine 1% by the surgeon (%)|intraoperatively||||participants|||Number
1305883|NCT02794870|Secondary|Number of Participants With B Cell Responses to Vaccine|A B cell response to vaccine is indicated by a greater than or equal to 4-fold change in serum antibody titers to RSV F glycoprotein between the pre- and post-inoculation time points, and between pre- and post-RSV surveillance time points.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study|One vaccine recipient had missing data for the post-RSV surveillance time point, and one placebo recipient had missing data for the pre- and post-RSV surveillance time points. All other participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
1305884|NCT02794870|Secondary|Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season.|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season subsequent to the time of the inoculation.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included.|||log 2 titers||Inter-Quartile Range|Median
1305885|NCT02794870|Secondary|Number of Participants Who Had Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season|The number of participants who had symptomatic, medically attended respiratory and febrile illness among those who had RSV detected in nasal washes or greater than or equal to 4 fold rise in serum antibodies during the subsequent RSV season were presented. A participant was only counted once in each solicited AE category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 4 and Table 5 in the protocol document.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|Only participants who had RSV detected in nasal washes or greater than or equal to 4 fold rise in serum antibodies during the subsequent RSV season were included.|||Participants|||Count of Participants
1305886|NCT02794870|Primary|Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Immunogenicity was assessed at approximately 2 months post-inoculation (Study Day 56).|Measured at Day 56|Study participants who received inoculation and were followed on study past Day 0 were included.|||log 2 titers||Inter-Quartile Range|Median
1305887|NCT02794870|Primary|Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer|Immunogenicity was assessed pre-inoculation, and at approximately 2 months post-inoculation (Study Day 56). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.|Measured at Day 0 and Day 56|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
1305888|NCT02794870|Primary|Duration of Virus Shedding in Nasal Washes|Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.|Only participants who met the definition of infection with vaccine virus were included.|||days||Inter-Quartile Range|Median
1305889|NCT02794870|Primary|Peak Titer of Vaccine Virus Shed|This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28|Only participants who met the definition of infection with vaccine virus were included.|||log10 PFU/mL||Inter-Quartile Range|Median
1305890|NCT02794870|Primary|Number of Participants Infected With RSV Vaccine|Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes) or 2) greater than or equal to 4-fold rise in serum RSV-neutralizing antibody titer between Study Days 0 and 56.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
1305925|NCT02793154|Primary|Part B: Assessment of Nausea by VAS Score|The VAS was used to measure the intensity of nausea analyzed on the basis of scores ranging from 0 (no nausea) to 100 (severe nausea). This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305939|NCT02793154|Primary|Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points|Blood samples were collected for analysis of clinical chemistry parameters including creatinine, direct bilirubin, total bilirubin, indirect bilirubin levels. Individual Par. data at indicated time points has been presented.|Day 5|All Subjects Population|||Micromoles per liter|||Number
1305891|NCT02794870|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:~Results in death during the period of protocol-defined surveillance~Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe~Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting~Results in a persistent or significant disability/incapacity~Is a congenital anomaly or birth defect~Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Measured from Day 0 through Day 56|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
1305892|NCT02794870|Primary|Number of Participants With Unsolicited AEs by Grade|Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).|Measured from Day 0 through Day 28|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
1305893|NCT02794870|Primary|Number of Participants With Solicited Adverse Events (AEs) by Grade|Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 4 and Table 5 in the protocol document.|Measured from Day 0 through Day 28|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
1305894|NCT02794844|Primary|Adverse Effects After Genotype-guided PPI Therapy|Count of participants reporting adverse effects after genotype-guided PPI therapy.|Throughout 12 month study||||Participants|||Count of Participants
1305895|NCT02794844|Primary|Count of Participants Agreeing to Future Use of DNA|Outcomes for evaluating the success of PGX implementation|Throughout 12 month study||||Participants|||Count of Participants
1305896|NCT02794844|Primary|Count of Providers Agreeing to Participate in Study|Outcomes for evaluating the success of PGX implementation|Throughout 12 month study|6 providers participated in the study|||Participants|||Count of Participants
1305897|NCT02794844|Primary|Count of Patients Reporting Efficacy and Toxicity Data|Outcomes for evaluating the success of PGX implementation|Throughout 12 month study||||Participants|||Count of Participants
1305898|NCT02794844|Primary|Count of Patients Agreeing to Volunteer for the Study|Outcomes for evaluating the success of PGX implementation|Through 12 months study||||Participants|||Count of Participants
1305899|NCT02794480|Post-Hoc|Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase|A supportive post-hoc analysis on the primary endpoint was performed to address possible concerns due to the exclusion of data from a large number of participants who made no errors or at least one error on either inhaler tested in the primary analysis (only discordant cases involved in the analysis). For each ELLIPTA versus MDI comparison separately (Sub-study 1: Ellipta vs GSK MDI and Sub-study 2: Ellipta vs AZ MDI), the percentage of par having zero errors in inhaler use at Day 28 was analyzed using a Conditional Logistic Regression adjusting for treatment (inhaler) and treatment period. NA indicates that the par did not receive the inhaler in that particular sub-study.|Up to Day 56|MITT|||Percentage of Participants|||Number
1305900|NCT02794480|Secondary|Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error)|The number of errors for each inhaler (ELLIPTA and GSK MDI or AZ MDI) in par with one or more errors were evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par. did not receive the inhaler in that particular sub-study. Only those par who made at least one error were included in the summary (represented by n=X, X in the category titles).|Up to Day 56|MITT Population|||Errors||Standard Deviation|Mean
1305901|NCT02794480|Secondary|Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par)|The number of errors per par for each inhaler (ELLIPTA and GSK MDI or AZ MDI) was evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par did not receive the inhaler in that particular sub-study.|Up to Day 56|MITT Population|||Errors||Standard Deviation|Mean
1305902|NCT02794480|Secondary|Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase|The occurrence of each type of error while using GSK MDI in Sub-Study 1 and AZ MDI in Sub-Study 2 was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. The number of errors is reported as NA for the type of error which was not applicable to the particular inhaler type. Only par who made at least one error are included in the summary (represented by the number of Participants).|Up to Day 56|MITT Population|||Participants|||Number
1305903|NCT02794480|Secondary|Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase|The occurrence of each type of error while using ELLIPTA inhaler was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. Only par who made at least one error was included in the summary (represented by the number of Participants).|Up to Day 56|MITT Population|||Participants|||Number
1306104|NCT02780622|Secondary|Terminal Half-life (t½) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||hours||Standard Deviation|Mean
1305904|NCT02794480|Primary|Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase|A checklist for correct use of each inhaler was developed based on the steps identified in the package insert. Baseline assessment was conducted when the par were dispensed the inhaler and were guided by a trained healthcare provider (HCP) to demonstrate correct use of the assigned inhaler. A second assessment was conducted after each 28 day dosing period without instruction by HCP. The Correct Use Check list was completed by HCP at each visit. Percentage of par with zero errors in inhaler use at Day 28, was analyzed using a Mainland-Gart test for each ELLIPTA versus MDI comparison separately (Sub-study 1: ELLIPTA vs GSK MDI and Sub-study 2: ELLIPTA vs AZ MDI). For each ELLIPTA vs MDI analyses, only par who made no error in any of the inhalers and at least one error on the other inhaler (discordant cases) were included in the analysis. NA indicates that par did not receive the inhaler in that particular sub-study.|Up to Day 56|Modified ITT Population (MITT) comprises of all par in the ITT Population who provided Day 28 inhaler use data for both of their randomized inhalers.|||Percentage of Participants|||Number
1305905|NCT02793947|Other Pre-specified|Number of Participants With Medication-related Side Effects|Patients will be monitored every 15 minutes in the recovery room and every 4 hours for the first two post-operative days by nursing personnel for medication side effects related to ropivacaine toxicity including blurred vision, hearing problems, transient peripheral paralysis, dizziness, convulsion, uncontrolled muscle contraction, hypotension, bradycardia, and new onset arrhythmia.|48 hours following surgery||||Participants|||Count of Participants
1305906|NCT02793947|Secondary|Total Narcotic Consumption|Parenteral and oral narcotic agents will be utilized by patients for post-operative pain control per the standard of care. No alterations in narcotic prescription behavior will be observed for this study.|Narcotic consumption will be recorded every 8 hours for the first two post-operative days.||||mg of morphine||Inter-Quartile Range|Mean
1305907|NCT02793947|Primary|Visual Analog Scale Pain Assessment|"Patients will describe their current level of comfort on a 10 point scale while at rest. Zero corresponds to no pain and ten corresponds to the most extreme possible pain. Visual analog scores will be collected by nursing staff who are blinded to the treatment allocation."|Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H)||||units on a scale||Inter-Quartile Range|Median
1305908|NCT02793674|Secondary|Maximum Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)|"Exploratory analysis of patients by further stratified weight groupings (<5 kg, 5-8 kg, and >8 kg) was performed to determine the greatest observed benefit of HFNC flow titration in patients of different sizes. For this outcome, the maximum percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|median of the maximum percent change in PRP over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||percent||Inter-Quartile Range|Median
1305909|NCT02793674|Secondary|Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)|"To assess the relationship between patient size and dose-response of HFNC flow rate, we compared subgroups stratified by weight (patients <8 kg and >8 kg). For this outcome, the median percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|medain percent change in PRP over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||percent change in PRP from baseline||Inter-Quartile Range|Median
1305910|NCT02793674|Secondary|Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems|For this outcome, a subgroup of patients (N=12) were examined who had PRP measurements obtained on two different HFNC delivery systems (Fisher & Paykel (FP) and Vapotherm (VT)) in back-to-back flow titration periods. With one exception, patients were first studied on the FP and then transitioned to the VT HFNC delivery system.|median PRP over a 5 minute period|Percent change in PRP from baseline (of 0.5 L/kg/min) was measured at different flow rates (1.0, 1.5, and 2.0 L/kg/min) for patients who had flow titrations done on the two different HFNC delivery systems (Fisher & Paykel (FP) and Vapotherm (VT)).|||percent change in PRP||Inter-Quartile Range|Median
1305911|NCT02793674|Secondary|Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)|"Phase angle is a measure of asynchrony between thoracic and abdominal breathing compartments that has correlated with increased effort of breathing. It is derived by measuring the relative expansion of these two breathing compartments and describing the synchrony between them as an angle (theta). For this outcome, the phase angle was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|median phase angle over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||degrees||Inter-Quartile Range|Median
1305912|NCT02793674|Secondary|Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)|"PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute). These values were obtained from 5 minute flow titration periods. For this outcome, the PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|median PRP over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||cmH20 * breaths/minute||Inter-Quartile Range|Median
1306105|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||hours||Full Range|Median
1305913|NCT02793674|Primary|Percent Change in Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)|"PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute).~The percent change in PRP is derived from the quotient of the absolute PRP at increased HFNC flow rates (1.0, 1.5, and 2.0 L/kg/min) divided by the absolute PRP at a baseline HFNC flow rate (0.5 L/kg/min). Percent change in PRP was used because a) there was a large degree of heterogeneity in baseline absolute PRP values in our study population based upon patient size, disease severity, and time point of illness, and b) we allowed for repeated measures on the same patient which would bias absolute PRP values in favor of those who were measured more frequently.~It was not pre-specified to compare the two different HFNC delivery systems."|median percent change in PRP over 5 minute measurement period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||percent change in PRP||Inter-Quartile Range|Median
1305914|NCT02793154|Secondary|Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 12 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305915|NCT02793154|Secondary|Part B: Assessment of GCSI-DD Score|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305916|NCT02793154|Secondary|Part B: Number of Par. With AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation Par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 12 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305917|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Urinalysis|Urinalysis included analysis of concentration of creatinine, presence of ketones and occult blood in urine (using dipstick test), presence RBC and WBC in urine (using microscopy), specific gravity and pH of urine. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305918|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters|Clinical chemistry parameters included ALT, AST, GGT, glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, BUN, creatinine, direct bilirubin, total bilirubin, indirect bilirubin, glomerular filtration rate (MDRD Enzymatic level), total protein, and albumin level. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305919|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Hematology Parameters|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils, WBC, RBC, hemoglobin and hematocrit levels. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305920|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Vital Signs|Vital signs included SBP, DBP and heart rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 12 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305921|NCT02793154|Secondary|Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score|EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305922|NCT02793154|Secondary|Part B: The Volume of Water Ingested During EGG|EGG with WLT is a standardized test to induce gastric distention. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305923|NCT02793154|Secondary|Part B: Rate of [13]C Dose Excreted in Breath|The rate of [13]C dose excreted in breath was assessed to study gastric empting using GEBT. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305924|NCT02793154|Secondary|Part B: Time to Half-gastric Emptying|The GEBT containing 13C-Spirulina was used to measure the time to half-gastric emptying. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305926|NCT02793154|Primary|Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal|EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with An WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305927|NCT02793154|Primary|Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region|EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305928|NCT02793154|Primary|Part B: Distribution of Average Power by Frequency Region|EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
1305929|NCT02793154|Primary|Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT.|Up to 12 days|All Subjects Population.|||Participants|||Number
1305930|NCT02793154|Primary|Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation Par. temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Number of Par. with AEs and SAEs have been presented.|Up to 12 days|All Subjects Population|||Participants|||Number
1305931|NCT02793154|Primary|Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points|Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine.Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Points on a scale|||Number
1305932|NCT02793154|Primary|Part A: Specific Gravity of Urine at Indicated Time Points|Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Kilograms per meter^3|||Number
1305933|NCT02793154|Primary|Part A: Presence RBC and WBC in Urine Assessed by Microscopy|"Samples were collected to analyze the presence of RBC and WBC in urine by microscopy. Individual Par. data at indicated time point has been presented. NA indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal. The RBC and WBC values of 1 for participant 1 actually reflect 0-1."|Day 5|All Subjects Population|||High Power field|||Number
1305934|NCT02793154|Primary|Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points|Urine samples were collected to analyze presence of ketones, occult blood, glucose, nitrates and leukocyte esterase in urine. The dipstick test gives results in a semi-quantitative manner. NA represents data was not available due to lab data transfer error. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Participants|||Number
1305935|NCT02793154|Primary|Part A: Concentration of Creatinine in Urine at Indicated Time Points|Samples were collected to analyze concentration of creatinine in urine. Individual Par. at indicated time point has been presented at indicated time points.|Day 5|All Subjects Population|||Micromoles per liter|||Number
1305936|NCT02793154|Primary|Part A: Albumin Level in Urine at Indicated Time Points|Samples were collected to analyze albumin level in urine. Individual Par. data at indicated time point has been collected.|Day 5|All Subjects Population|||Milligrams per liter|||Number
1305937|NCT02793154|Primary|Part A: Total Protein, Albumin Levels at Indicated Time Points|Blood samples were collected for analysis of clinical chemistry parameters including total protein and albumin levels. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Grams per liter|||Number
1305938|NCT02793154|Primary|Part A: Estimated Glomerular Filtration Rate at Indicated Time Points|"Estimated glomerular filtration rate was calculated using the modification of diet in renal disease (MDRD) formula by multiplying 175 with serum creatinine^-1.154 multiplied by age^-0.203 multiplied by 0.742 (if female) multiplied by 1.212 (if African American Par.). Individual Par. data at indicated time point has been presented."|Day 5|All Subjects Population|||Milliliter per second per 1.73 meter ^2|||Number
1306106|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||hours||Full Range|Median
1305940|NCT02793154|Primary|Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels|Blood samples were collected for analysis of glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, and urea/BUN levels. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Millimoles per liter|||Number
1305941|NCT02793154|Primary|Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points|Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and GGT. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||International unit per liter|||Number
1305942|NCT02793154|Primary|Part A: Hematocrit Level at Indicated Time Points|Blood samples were collected for analysis of hematocrit level. Individual Par. data at indicated time points has been presented.|Day 5|All Subjects Population|||Proportion of RBC in blood|||Number
1305943|NCT02793154|Primary|Part A: Hemoglobin Level at Indicated Time Points|Blood samples were collected for analysis of hemoglobin level. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Grams per liter|||Number
1305944|NCT02793154|Primary|Part A: Red Blood Cell (RBC) Count at Indicated Time Points|Blood samples were collected for analysis of RBC count. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Tetra unit per liter|||Number
1305945|NCT02793154|Primary|Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points|Blood samples were collected for analysis of hematology parameters including basophils, eosinophil, lymphocytes, monocytes, platelet count, total neutrophils, and WBC. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Giga unit per liter|||Number
1305946|NCT02793154|Primary|Part A: Assessment of Heart Rate (HR) as a Measure of Safety|HR was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for HR up to follow-up (up to 12 days) has been presented.|Up to 12 days|All Subjects Population|||Beats per minute|||Number
1305947|NCT02793154|Primary|Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety|SBP and DBP was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for SBP and DBP up to follow-up (up to 12 days) has been presented.|Up to 12 days|All Subjects Population|||Millimeter of mercury|||Number
1305948|NCT02793154|Primary|Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score|The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. The intensity of upper gastrointestinal symptoms was measured using VAS scores ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). Individual Par. responses to VAS has been presented.|Day 4|Pharmacodynamic Population|||Scores on VAS scale|||Number
1305949|NCT02793154|Primary|Part A: The Volume of Water Ingested During EGG|The volume of water consumed by Par. at indicated time points after treatment with exenatide during EGG with WLT was determined. An EGG with WLT is a standardized test to induce gastric distention. Individual Par. data has been presented.|Up to Day 4|Pharmacodynamic Population|||Milliliter|||Number
1305950|NCT02793154|Primary|Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: episodes (epi) of vomiting, epi of retching, nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe),to 5 (very severe). Individual Par. data has been presented. All Subjects Population was used which consisted of all Par. who received at least one dose of study medication.|Up to Day 5|All Subjects Population|||Scores on GCSI-DD scale|||Number
1305951|NCT02793154|Primary|Part A: Rate of [13]C Dose Excreted in Breath|The effect of exenatide on gastric emptying was be assessed by calculating the percent dose excreted of 13C in breath multiplied by 1000 (kPCD). Breath samples were collected at the indicated time points. Individual Par. data at pre-meal and 45, 90, 120, 150, 180 and 240 minutes post-meal has been presented.|Day 5|Pharmacodynamic Population|||kPCD per minute|||Number
1305952|NCT02793154|Primary|Part A: Time to Half-gastric Emptying|Breath samples were collected to assess the time to half gastric emptying using gastric emptying breath test (GEBT) containing 13 Carbon (13C)-Spirulina pre-meal and post GEBT meal. The GEBT method was used to measure GE of solid food. The time to half gastric emptying for individual Par. has been presented.|Up to Day 5|Pharmacodynamic Population|||Minutes|||Number
1305953|NCT02793154|Primary|Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score|The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces nausea in Par. allowing the assessment of gastric myoelectrical activity during the episodes of nausea. The intensity of upper gastrointestinal symptom of nausea was measured using VAS ranging from 0 (no nausea) to 100 (severe nausea) immediately before (pre-WL) and 10, 20, 30 minutes post-WL. Individual Par. responses to VAS score scale has been presented.|Day 4|Pharmacodynamic Population|||Scores on a scale|||Number
1305954|NCT02793154|Primary|Part A: Average Dominant Frequency|The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for average dominant frequency in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at Pre-WL and 10, 20, 30 minutes post-WL has been presented.|Up to Day 4|Pharmacodynamic Population|||Cycles per minute|||Number
1309490|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||Cells/μL||Standard Deviation|Mean
1305955|NCT02793154|Primary|Part A: Number Par. by Gastric Rhythm Status|EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.|Up to 12 days|Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.||||||
1305956|NCT02793154|Primary|Part A: Number of Par. With Shifts in Gastric Rhythm Status|EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.|Up to 12 days|Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.||||||
1305957|NCT02793154|Primary|Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal|The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for dominant EGG frequencies including bradygastria, normal, tachygastria and duodenal at pre-WL and after treatment with exenatide at pre-WL and 10, 20, 30 minutes post-WL has been presented.|Up to Day 4|Pharmacodynamic Population|||Percentage of time|||Number
1305958|NCT02793154|Primary|Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region|The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for ratios of average power post- WLT/pre-WLT in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at 10, 20, and 30 minutes post-WL has been presented.|Up to Day 4|Pharmacodynamic Population|||Ratio|||Number
1305959|NCT02793154|Primary|Part A: Distribution of Average Power by Frequency Region|The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for distribution of average power in the bradygastria, normal, tachygastria and duodenal range during pre-WL and 10, 20 and 30 minutes post-WL after treatment with exenatide has been presented. The analysis was performed on Pharmacodynamic Population, which included all Par. who received at least one dose of study medication and had valid data.|Up to Day 4|Pharmacodynamic Population|||Percentage of power|||Number
1305960|NCT02792062|Secondary|Number of Participants With TEAEs Related to Clinical Laboratory Tests|Clinical laboratory tests included hematology, serum chemistry, and urinalysis.|Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
1305961|NCT02792062|Secondary|Number of Participants With TEAEs Related to Electrocardiograms (ECG)||Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
1305962|NCT02792062|Secondary|Number of Participants With TEAEs Related to Body Weight||Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
1305963|NCT02792062|Secondary|Number of Participants With TEAEs Related to Vital Signs (Presyncope)||Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
1305964|NCT02792062|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.||Day 1 up to 12 days after the last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
1305965|NCT02792062|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||ng*hr/mL||Standard Deviation|Mean
1305966|NCT02792062|Primary|AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||ng*hr/mL||Standard Deviation|Mean
1305967|NCT02792062|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1305968|NCT02792062|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-385||Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1305969|NCT02792049|Secondary|Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)|Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM.|Within 10 minutes of study completion||||participants|||Number
1305970|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation|Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use).|Within 10 minutes of study completion||||Units on a scale||Inter-Quartile Range|Median
1305971|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Better Seal Formation|Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation).|Within 10 minutes of study completion||||Units on a scale||Inter-Quartile Range|Median
1305972|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Ease of Use|Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5).|Within 10 minutes of study completion||||Units on a scale||Inter-Quartile Range|Median
1305973|NCT02792049|Primary|Mean Received Tidal Volume|Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters|3 minutes||||milliliters||Standard Deviation|Mean
1305974|NCT02791659|Primary|Effective Radiation Dose|The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.|Immediate after procedure||||mSv||Inter-Quartile Range|Median
1305975|NCT02791269|Secondary|Number of Participants With HBeAg Seroconversion|HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Only HBeAg positive participants was planned to be reported. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
1305976|NCT02791269|Secondary|Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level|ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
1305977|NCT02791269|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
1305978|NCT02791269|Secondary|Number of Participants With HBV-DNA <400 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
1305979|NCT02791269|Primary|Number of Participants With HBV-DNA <20,000 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|End of 24-weeks follow-up (Week 72)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||participants|||Number
1305980|NCT02791269|Primary|Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)|HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.|End of 24-weeks follow-up (Week 72)|"Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had one subsequent post baseline assessment. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||participants|||Number
1305981|NCT02790281|Primary|Exploratory: Levels of C-reactive Protein (CRP)|Blood sample was taken for analysis of levels of CRP.|At Day 1|All eligible subjects with CRP >5 mg/L|||mg/L||Full Range|Median
1305982|NCT02790281|Primary|Exploratory: Levels of IL-6|Blood sample was taken for analysis of levels of IL-6.|At Day 1|All eligible subjects with CRP >5 mg/L|||pg/mL||Full Range|Median
1305983|NCT02790281|Primary|Exploratory: Levels of IL-6/sIL-6R Complex|Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.|At Day 1|All eligible subjects with CRP >5 mg/L.|||pg/mL||Full Range|Median
1305984|NCT02788357|Secondary|Transcranial Magnetic Stimulation||Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline|This data is not available at this time, as a relocation occurred during the project. Data collected at the previous institution used different software and stored the data in a different format than is currently used. Therefore, reconciliation of this data is being attempted at this time.||||||
1306002|NCT02786004|Secondary|Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect and Device Defects by Overall Occurrence.|Overall clinical image quality was assessed as acceptable for 100% of the NextGen FFDM and DBT image sets evaluated in this study, and there were no AEs, SAEs, or UADEs reported in this study.|Through study completion, approximately 3 months||2017-06-30|06/2017||||
1305985|NCT02788357|Secondary|Change in Wolf Motor Function Test (WMFT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.|baseline, post-intervention, 1-month follow-up|3 subjects in the Atomoxetine group were lost to follow-up.|||log(seconds)||95% Confidence Interval|Mean
1305986|NCT02788357|Secondary|Change in Action Arm Research Test (ARAT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.|baseline, post-intervention, 1-month follow-up|3 subjects in the Atomoxetine group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
1305987|NCT02788357|Primary|Change in Fugl Meyer Assessment|Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.|baseline, post-intervention, 1-month follow-up|3 subjects in Atomoxetine group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
1305988|NCT02788188|Primary|Number of Participants Having Adverse Events|Number of participants who experienced an adverse event|90 days|Number of participants who completed both treatment and placebo|||Participants|||Count of Participants
1305989|NCT02788097|Primary|Biochemical Pregnancy|>30IU/L of serum βhCG on day 14 of cycle|1 year||||percentage of participants|||Number
1305990|NCT02787564|Secondary|Amount of Fruits and Vegetables Among Non-Food Bank Users|Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among non-Food Bank Users.|baseline and 4 weeks||||portions/day||Standard Deviation|Mean
1305991|NCT02787564|Secondary|Variety of Fruits and Vegetables Among Non-Food Bank Users|Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among non-Ffood Bank Users|baseline and 4 weeks||||types/day||Standard Deviation|Mean
1305992|NCT02787564|Secondary|Amount of Fruits and Vegetables Among Food Bank Users|Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users|baseline and 4 weeks||||portions/day||Standard Deviation|Mean
1305993|NCT02787564|Secondary|Variety of Fruits and Vegetables Among Food Bank Users|Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.|baseline and 4 weeks||||types/day||Standard Deviation|Mean
1305994|NCT02787564|Primary|Amount of Fruits and Vegetables|Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks|baseline and 4 weeks||||portions/day||Standard Deviation|Mean
1305995|NCT02787564|Primary|Variety of Fruits and Vegetables|Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks|baseline and 4 weeks||||types/day||Standard Deviation|Mean
1305996|NCT02786927|Secondary|Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler|Preference between ELLIPTA inhaler and HandiHaler based on the size of the inhaler was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.|Up to 18 days|Modified ITT Population|||Percentage of participants|||Number
1305997|NCT02786927|Secondary|Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left|Preference between ELLIPTA inhaler and Handihaler based on how easy it was to tell how many doses were left was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.|Up to 18 days|Modified ITT Population|||Percentage of participants|||Number
1305998|NCT02786927|Primary|Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication|Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.|Up to 18 days|Modified ITT Population|||Percentage of participants|||Number
1305999|NCT02786810|Secondary|Number of Participants With Adverse Events Related to the Study Drug.|The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study.|1 week||||participants|||Number
1306000|NCT02786810|Primary|Visualization of Renal Scars Compared to Previous Imaging|The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent.|1 hour|In addition to the 7 patients analyzed, 3 participants were excluded from this analysis because they did not have previous scars to analyze.|||Percentage of previous scars visualized|||Number
1306001|NCT02786771|Primary|Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout|"The change of perceived stress and stress resilience within and between Group 1 and 2 from enrollment to closeout.~The change of perceived stress is measured by the Perceived Stress Scale-14 (a validated psychological instrument of 14 items), each each rated on a 5 point scale(0-4) for measuring the respondent’s perception of stress in the past month.The PSS-14 ranges from 0 to a high score of 56, with a higher score indicating more stress (worse outcome).~The change of stress resilience is measured by the Connor-Davidson Stress Resilience Scale (25 items). It evaluates different aspects of stress coping ability that seeks to understand how well respondents would be able to buffer adverse conditions and cope with stress, each rated on a 5 point scale (0-4). The CD-RISC ranges from 0 to 100, with a higher score representing better stress resilience (a better outcome)."|total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)|Adults over 18 who responded to a online advertisement|||units on a scale||Standard Deviation|Mean
1306003|NCT02786004|Primary|Image Quality Assessment by MQSA Qualified Radiologist to Access Sufficiently Acceptable Image Quality for Use in Clinical Mammography.|Overall clinical image quality was assessed as acceptable for 100% of the NextGen FFDM and DBT image sets evaluated in this study.|At enrollment completion approximately 3 months post initiation||||Participants|||Count of Participants
1306004|NCT02784925|Primary|Subcutaneous Fat in Steatosis Patients||up to 6 months|fatty liver patients|||cm^3||95% Confidence Interval|Mean
1306005|NCT02784275|Secondary|Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline|Individual 19 domains were calculated as a weighted score (WS) for each domain. Average weighted impact score = summing of WS for each domain/19 domains. Total range possible is -9 to 3, and higher number means improvement in quality of life.|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 ADDQoL results (9, 15, 14, and 13, respectively).|||Score on a scale||Standard Deviation|Mean
1306006|NCT02784275|Secondary|Change of Oral Glucose Tolerance Test From Baseline|Change in oral glucose tolerance test results from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 oral glucose tolerance test results (12, 15, 14, and 12, respectively).|||mg/dL||Standard Deviation|Mean
1306007|NCT02784275|Secondary|Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline|Change in postprandial (2 hours after dinner) blood glucose levels from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 postprandial glucose values (11, 14, 14, and 12, respectively).|||mg/dL||Standard Deviation|Mean
1306008|NCT02784275|Secondary|Change in Waist Circumference From Baseline|Change in waist circumference from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 values (12, 14, 14, and 13 respectively).|||cm||Standard Deviation|Mean
1306009|NCT02784275|Secondary|Proportion of Subjects Achieving HbA1c Goal of <6.5%|Percent of subjects who achieved HbA1c of <6% at Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively).|||Participants|||Count of Participants
1306010|NCT02784275|Secondary|Proportion of Subjects Achieving HbA1c Goal of <7.0%|Percent of subjects who achieved HbA1c of <7% at Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13 respectively).|||Participants|||Count of Participants
1306011|NCT02784275|Secondary|Change of Fasting Plasma Glucose Level From Baseline|Change in fasting plasma glucose from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively).|||mg/dL||Standard Deviation|Mean
1306012|NCT02784275|Primary|Change of Body Weight From Baseline|Change in body weight from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values for weight (12, 15, 14, and 13, respectively).|||kg||Standard Deviation|Mean
1306013|NCT02784275|Primary|Change of HbA1c Level From Baseline|Change in HbA1c from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However only 54 subjects had Week 12 values (12, 15, 14, and 13 subjects, respectively).|||(%)||Standard Deviation|Mean
1306014|NCT02784106|Secondary|Absolute Change From Baseline in B-cell Levels at Day 85||Baseline, Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||cells per micro-liter||Standard Deviation|Mean
1306015|NCT02784106|Secondary|Absolute B-Cell Levels at Day 85||Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||cells per micro-liter||Standard Deviation|Mean
1306016|NCT02784106|Secondary|Absolute Change From Baseline in Immunoglobulin Levels at Day 85|Following immunoglobulin levels were measured: Immunoglobulin A , Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M.|Baseline, Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||gram/Liter||Standard Deviation|Mean
1306017|NCT02784106|Secondary|Absolute Immunoglobulin Levels at Day 85|Following immunoglobulin levels were measured: Immunoglobulin A , Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M.|Baseline, Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||gram/Liter||Standard Deviation|Mean
1306018|NCT02784106|Secondary|Accumulation Ratio for Observed Maximum Plasma Concentration (Racc [Cmax]) of M2951|Accumulation ratio for Cmax , was calculated as Cmax, Day 29 divided by Cmax, Day1|Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||ratio||Standard Deviation|Mean
1306019|NCT02784106|Secondary|Accumulation Ratio for Area Under the Concentration-Time Curve From Time Zero to 6 Hours (Racc [AUC0-6h]) of M2951|Accumulation ratio for AUC was calculated as AUC 0-6h, Day 29 divided by AUC 0-6h, Day 1|Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||ratio||Standard Deviation|Mean
1309491|NCT02607956|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 144||Baseline; Week 144|||||||
1306020|NCT02784106|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of M2951||Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||hour||Full Range|Median
1306021|NCT02784106|Secondary|Plasma Concentration Observed Immediately Before Dosing on Day 29 (Cpre) of M2951||Pre-dose on Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||ng/mL||Standard Deviation|Mean
1306022|NCT02784106|Secondary|Maximum Observed Plasma Concentration (Cmax) of M2951||Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||ng/mL||Standard Deviation|Mean
1306023|NCT02784106|Secondary|Area Under the Concentration-Time Curve From Time Zero to 6 Hours (AUC 0-6h) of M2951||Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||hours*nanogram/milliliter||Standard Deviation|Mean
1306024|NCT02784106|Secondary|Plasma Concentration of M2951||Pre-dose at Day 1; 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"The Pharmacokinetic (PK) Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1306025|NCT02784106|Secondary|Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings|The 12-lead ECG recordings were obtained after 10 minutes of rest in a semi-supine position. The ECG parameters obtained directly from the computerized 12-lead ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, and QT interval. Clinical significance was determined by the investigator.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
1306026|NCT02784106|Secondary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Vital sign assessment included blood pressure, pulse rate, respiratory rate and temperature. Clinical significance was determined by the investigator.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
1306027|NCT02784106|Secondary|Number of Participants With Grade 3 or Higher Clinically Significant Abnormality for Hematology, Biochemistry, Urinalysis or Coagulation|Clinically significant abnormalities for hematology, biochemistry or coagulation were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 toxicity grades, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death. Participants with grade 3 or higher were reported.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
1306028|NCT02784106|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity|Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
1306029|NCT02784106|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
1306030|NCT02784106|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on Visual Analog Scale (VAS) Score at Day 84|The Physician’s Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant’s arthritis disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis).|Baseline, Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||millimeter||Standard Deviation|Mean
1306053|NCT02782676|Secondary|Mean Change in IOP From Baseline|The mean change in IOP from baseline for both OVD groups over time at the 6 hour, 1 day, 1 week, 1 month, and 3 month postoperative time points are presented.|3 months|Results are based on paired-eye subjects included in the safety population.|||mmHg|eyes|Standard Deviation|Mean
1306142|NCT02777268|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0.|To assess the safety and tolerability of Infacort® throughout the study. For a full list of TEAEs per arm, please refer to the Adverse Events section.|1 day||||TEAEs|||Number
1306031|NCT02784106|Secondary|Change From Baseline in Self-assessment of Disability Using Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Day 84|The HAQ-DI questionnaire assessed the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Day 84|"mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1306032|NCT02784106|Secondary|Change From Baseline in Self-assessment of Pain Based on Visual Analog Scale (VAS) Score at Day 84|The participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 indicated no pain and 100 indicated worst possible pain.|Baseline, Day 84|"mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||millimeter||Standard Deviation|Mean
1306033|NCT02784106|Secondary|Change From Baseline in Global Assessment of Disease Activity Based on Visual Analog Scale (VAS) Score at Day 84|The participant’s overall assessment of disease activity was recorded using the 100 millimeter (mm) horizontal visual analog scale (VAS). The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity).|Baseline, Day 84|"mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||millimeter||Standard Deviation|Mean
1306034|NCT02784106|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Day 28 and 84|Rheumatoid Factor is an anti-body present in the blood.|Baseline, Day 28 and Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||kiloUnit/Liter (kU/L)||Standard Deviation|Mean
1306035|NCT02784106|Secondary|Change From Baseline in Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody Levels at Day 28 and 84|Anti-cyclic citrullinated peptide (anti-CCP) is an antibody present in most rheumatoid arthritis participants.|Baseline, Day 28 and Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||units/milliliter||Standard Deviation|Mean
1306036|NCT02784106|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 28 and 84|Erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. Higher values indicate inflammation in the body.|Baseline, Day 28 and Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||millimeter/hour (mm/hour)||Standard Deviation|Mean
1306037|NCT02784106|Secondary|Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 2.6|DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and participant’s global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP =0.56* sqrt (TJC28) + 0.28*sqrt (SJC28)+ 0.014* participant’s global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Proportion of participants with DAS28-hsCRP value <2.6 were reported.|Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
1306038|NCT02784106|Secondary|Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 3.2|DAS28-hsCRP consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and participant’s global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP =0.56* sqrt(TJC28) + 0.28*sqrt(SJC28)+ 0.014* participant’s global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Proportion of participants with DAS28-hsCRP value <3.2 were reported.|Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
1306039|NCT02784106|Secondary|Mean Change From Baseline in Disease Activity Score Based on a 28 Joint Count High-Sensitivity C-Reactive Protein (DAS28-hsCRP) at Day 28 and 84|Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant’s global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56*square root (sqrt) (TJC28) plus (+) 0.28*sqrt (SJC28)+ 0.014* participant’s global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Day 28 and Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||units on a scale||Standard Error|Mean
1306040|NCT02784106|Secondary|Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 84|Mean change in the hsCRP concentration from baseline at Day 84 was reported.|Baseline, Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||mg/mL||Standard Error|Mean
1309492|NCT02607956|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 96||Baseline; Week 96|||||||
1306041|NCT02784106|Secondary|Proportion of Participants Achieving American College of Rheumatology-70 (ACR70) Response|ACR 70 response: >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by HAQ-DI; and 5) acute phase reactant as measured by hsCRP. Proportion of ACR70 responders = Number of participants with ACR70 response divided by total participants.|Day 28, Day 56 and Day 84|mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
1306042|NCT02784106|Secondary|Proportion of Participants Achieving American College of Rheumatology-50 (ACR50) Response|ACR 50 response: >=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by HAQ-DI; and 5) acute phase reactant as measured by hsCRP. Proportion of ACR50 responders = Number of participants with ACR50 response divided by total participants.|Day 28, Day 56 and Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
1306043|NCT02784106|Secondary|Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 28|Mean change in the hsCRP concentration from baseline at Day 28 was reported.|Baseline, Day 28|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||milligram/milliliter (mg/mL)||Standard Error|Mean
1306044|NCT02784106|Primary|Proportion of Participants Who Achieved American College of Rheumatology-20 (ACR20) Response|ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); and 5) acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Proportion of ACR20 responders = Number of participants with ACR20 response divided by total participants.|Day 84|The Modified Intent-to-Treat (mITT) Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
1306045|NCT02782676|Secondary|Grade of Inflammation: Fibrin Presence|The grades of inflammation for Fibrin Presence was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 Months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
1306046|NCT02782676|Secondary|Grade of Inflammation: Posterior Synechiae|The grades of inflammation for Posterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 Months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
1306047|NCT02782676|Secondary|Grade of Inflammation: Anterior Synechiae|The grades of inflammation for Anterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
1306048|NCT02782676|Secondary|Grade of Inflammation: Flare|The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
1306049|NCT02782676|Secondary|Grade of Inflammation: Cells|The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
1306050|NCT02782676|Secondary|Grade of Inflammation: Stromal Edema|The grades of inflammation for stromal edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
1306051|NCT02782676|Secondary|Grade of Inflammation: Epithelial Edema|The grades of inflammation for epithelial edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
1306052|NCT02782676|Secondary|Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively|The rate of IOP spike 30 mmHg or greater at 6 hour, 1 day, 1 week, 1 month and 3 months postoperatively was tabulated with frequency and proportion by OVD group.|3 months|Results are based on paired-eye subjects included in the safety population.|||eyes|eyes||Count of Units
1306054|NCT02782676|Secondary|Ocular Serious Adverse Events (SAE)|"Ocular serious and/or device related adverse event rates was be tabulated with the frequency and proportion of eyes with these events reported over time and cumulatively by OVD group.~* in the results table denotes SAEs determined to be device-related"|3 months|The results are consist of all subjects who had any study OVD used and with data available at the time of analysis.|||Eyes|Eyes||Count of Units
1306055|NCT02782676|Primary|Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively|The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.|3 months|Results are based on paired-eye subjects included in the safety population, which differs from the total number of participant (paired + non-paired eyes) safety population used in the Participant Flow. ECC photos were taken outside of the 3-month visit window for two subjects; therefore, the data was excluded from the analysis.|||percent change||95% Confidence Interval|Mean
1306056|NCT02782676|Primary|Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively|The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.|3 months|Results are based on paired-eye subjects included in the safety population, which differs from the total number of participant (paired + non-paired eyes)safety population used in the Participant Flow.|||Participants|||Count of Participants
1306057|NCT02782169|Secondary|Satisfaction With Analgesia|5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)|Asked at time point of 24 hours||||Participants|||Count of Participants
1306058|NCT02782169|Secondary|Number of Participants Ever Experiencing Different Symptoms During Abortion|A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||participants|||Number
1306059|NCT02782169|Secondary|Number of Oxycodone/Acetominophen Tablets (5/325mg) Used|summed number of tablets used by each participant over the 72 hour study period|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||tablets||Inter-Quartile Range|Median
1306060|NCT02782169|Secondary|Number of Ibuprofen 800mg Tablets Used|summed number of tablets used by each participant over the 72 hour study period|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||tablets||Inter-Quartile Range|Median
1306061|NCT02782169|Primary|Maximum Pain Score Over Study Period|reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||units on a scale||Standard Deviation|Mean
1306062|NCT02781818|Secondary|Patient Rating of Impression of Treatment at Day 14|"Patients will rate their impression of the treatment for each site as follows:~0. Made it worse;~Not helpful;~A little bit helpful;~Moderately helpful;~Very helpful~Comparison of rating of impression of treatment between the combined treatment groups and placebo will be performed. Similar comparison will be performed between the triamcinolone 10mg/ml and triamcinolone 40mg/ml treatment arms."|14 days||||units on a scale|Lesions|95% Confidence Interval|Mean
1306063|NCT02781818|Secondary|Change in Pain From Baseline to Day 5|Patients will rate pain on a scale of 1-10 (1 being no pain, 10 being the worst possible pain) at the baseline visit and on day 5. A secondary outcome will compare reduction in pain on day 5 in the combined treatment groups compared to the placebo group, and between the two treatment arms.|Baseline, Day 5||||units on a scale|Lesions|95% Confidence Interval|Mean
1306064|NCT02781818|Primary|Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.|Mean number of days that patient reports it takes for a lesion to resolve. This is defined as a return of the skin to baseline in the treated area and an absence of pain.|1-14 days||||Days|Lesions|95% Confidence Interval|Mean
1306065|NCT02781649|Secondary|Kidney Function at 12 Months|Serum creatinine mg/dL at 12 months following transplantation|12 months following transplantation||||mg/dL||Full Range|Median
1306066|NCT02781649|Secondary|Kidney Function at 6 Months|Serum creatinine mg/dL at 6 months following transplantation|6 months following transplantation||||mg/dL||Full Range|Median
1306067|NCT02781649|Secondary|IP-10 Elevations|Measurement of interferon (IFN)-gamma inducible protein 10 (IP-10) a marker of acute hepatitis C infection.|12 weeks|Data were not collected||||||
1306068|NCT02781649|Secondary|Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors|"Number of participants with NS5A resistance mutations in the HCV population from the deceased donors.~Number of donors with NS5A resistance mutations"|Baseline||||Participants|||Count of Participants
1306069|NCT02781649|Secondary|Antibody Development|Number of kidney transplant recipients who become reactive for HCV antibody|12 weeks||||Participants|||Count of Participants
1306070|NCT02781649|Secondary|Viral Response|This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12|12 weeks after completing treatment||||Participants|||Count of Participants
1306071|NCT02781649|Primary|Number of Participants With Grade 3 or Higher Treatment-related Adverse Events as US Department of Health and Human Services Common Terminology of Adverse Events (CTCAE) Version 4|Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.|12 weeks after transplant||||Participants|||Count of Participants
1307065|NCT02721277|Primary|Inflammation of the Liver Between the Groups|Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.|6 months|Study was terminated due to insufficient enrollment||||||
1306072|NCT02781571|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 12 weeks of treatment)~Virologic relapse:~HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement"|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
1306073|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306074|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306075|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306076|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306077|NCT02781571|Secondary|HCV RNA at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306078|NCT02781571|Secondary|HCV RNA at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306079|NCT02781571|Secondary|HCV RNA at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306080|NCT02781571|Secondary|HCV RNA at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306081|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306082|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306083|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306084|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306085|NCT02781571|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
1306086|NCT02781571|Primary|Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who took at least 1 dose if the study drug.|||percentage of participants|||Number
1306087|NCT02781571|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who took at least 1 dose of the study drug|||percentage of participants||95% Confidence Interval|Number
1306088|NCT02780661|Secondary|Change From Baseline in Candidal Microbial Count on Day 3|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.|Baseline (Day 0 pre-treatment), Day 3 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
1306089|NCT02780661|Secondary|Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated anaerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.|Baseline (Day 0 pre-treatment), Day 3 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
1306100|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1306101|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||liters per hour (L/h)||Standard Deviation|Mean
1306102|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for Oseltamivir||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||liters per hour (L/h)||Standard Deviation|Mean
1306090|NCT02780661|Secondary|Change From Baseline in Aerobic Bacteria Microbial Count on Day 3|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.|Baseline (Day 0 pre-treatment), Day 3 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
1306091|NCT02780661|Primary|Change From Baseline in Candidal Microbial Count on Day 7|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.|Baseline (Day 0 pre-treatment), Day 7 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
1306092|NCT02780661|Primary|Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated anaerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.|Baseline (Day 0 pre-treatment), Day 7 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
1306093|NCT02780661|Primary|Change From Baseline in Aerobic Bacteria Microbial Count on Day 7|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10-millimeter (mm) filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.|Baseline (Day 0 pre-treatment), Day 7 (post-treatment)|Analysis for this outcome was performed on intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU[colony forming unit]/disc+1)||Standard Deviation|Mean
1306094|NCT02780622|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 26|All enrolled participants.|||percentage of participants|||Number
1306095|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL/mg||Standard Deviation|Mean
1306096|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL||Standard Deviation|Mean
1306097|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL/mg||Standard Deviation|Mean
1306098|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 and 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL||Standard Deviation|Mean
1306099|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the Cmax values (nanograms per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||Nanogram/milliliter/milligram (ng/mL/mg)||Standard Deviation|Mean
1355136|NCT01732783|Primary|Total Number of Panitumumab Infusions||12 months||||infusions||Inter-Quartile Range|Median
1306107|NCT02780622|Primary|Change From Baseline in Plasma Concentration of Vitamin K1|Vitamin K1 is required by proteins involved in blood clotting. Food interaction with warfarin can lead to decreases in Vitamin K1 in plasma. An increase in vitamin K1 signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1 and 24 hours post-dose on Day 5|All enrolled participants.|||nanogram per liter (ng/L)||Full Range|Mean
1306108|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in Factor VII Activity (Tmax)|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.|||hours||Full Range|Median
1306109|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) in Factor VII Activity|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.|||kIU/L||Full Range|Mean
1306110|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for Factor VII Activity|Factor VIIa is a protein that causes blood to clot, and low levels in the blood can cause excessive or prolonged bleeding after an injury or surgery. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.|||hours*kIU/L||Full Range|Mean
1306111|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in International Normalized Ratio (INR) (Tmax)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.|||hours||Full Range|Median
1306112|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) of International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.|||ratio||Full Range|Mean
1306113|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. An increase in INR signifies enhancement of warfarin’s anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.|||hours*ratio||Full Range|Mean
1306114|NCT02780349|Primary|Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.|MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)|30 days||||Participants|||Count of Participants
1306115|NCT02780167|Secondary|Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points|The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
1306116|NCT02780167|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points|"The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28. The higher values represent more severe AD."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
1306117|NCT02780167|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points|"The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as very much (3), a lot (2), a little (1) and not at all (0). The score can range from 0 to 30. The higher values represent the worse dermatology life quality."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
1309299|NCT02613871|Secondary|Serum Lysyl Oxidase-like 2 (LOXL-2) Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12||Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12|Full Analysis Set|||pg/mL||Standard Deviation|Mean
1306118|NCT02780167|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points|"The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, severe (4), moderate (3), mild (2),almost clear (1), and clear (0). The PtGA was completed as per schedule of activities."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306119|NCT02780167|Secondary|Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)||Baseline up to Week 16|Safety Analysis Set: All participants who received at least 1 dose of study treatment.|||participants|||Number
1306120|NCT02780167|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.|Baseline till Week 16|Safety Analysis Set: All participants who received at least 1 dose of study treatment.|||participants|||Number
1306121|NCT02780167|Secondary|Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points|SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306122|NCT02780167|Secondary|Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points|SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306123|NCT02780167|Secondary|Percent Change From Baseline in SCORAD at All Scheduled Time Points|SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percent change||Standard Deviation|Mean
1306124|NCT02780167|Secondary|Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points|SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where “0” is no itch (or no sleeplessness) and “10” is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
1306143|NCT02777268|Secondary|Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|1 day||||H*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1306125|NCT02780167|Secondary|Change From Baseline in Affected BSA at All Scheduled Time Points|BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of BSA||Standard Deviation|Mean
1306126|NCT02780167|Secondary|Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306127|NCT02780167|Secondary|Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306128|NCT02780167|Secondary|Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306129|NCT02780167|Secondary|Change From Baseline in Pruritus NRS Score at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
1306130|NCT02780167|Secondary|Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percent change||Standard Deviation|Mean
1306131|NCT02780167|Secondary|Time to Achieving >=4 Points Improvement in NRS|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10)."|Baseline till Week 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||day||90% Confidence Interval|Median
1306132|NCT02780167|Secondary|Time to Achieving >=3 Points Improvement in NRS|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10)."|Baseline till Week 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||day||90% Confidence Interval|Median
1306133|NCT02780167|Secondary|Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306134|NCT02780167|Secondary|Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “worst itching due to AD over the past 24 hours” on a NRS anchored by the terms “no itching” (0) and “worst possible itching” (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their “frequency of itching due to AD over the past 24 hours” on a NRS anchored by the terms “never/no itching” (0) and “always/constant itching” (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306135|NCT02780167|Secondary|Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||Percent change||Standard Deviation|Mean
1306136|NCT02780167|Secondary|Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points|The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306137|NCT02780167|Secondary|Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12|The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).|Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.|"Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
1306138|NCT02780167|Secondary|Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|Baseline and Week 12|"Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percent change||Standard Error|Least Squares Mean
1306139|NCT02780167|Primary|Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12|The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).|Baseline and Week 12|"Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants||Standard Error|Least Squares Mean
1306140|NCT02777931|Primary|Clinical Global Impression – Global Improvement (CGI –I) Response|"The CGI-I item is rated on a 7-point scale from 1 = “Very much improved”, 2 = “Much improved”, 3 = “Minimally improved”, 4 = “No change”, 5 = “Minimally worse”, 6 = “Much worse”, 7 = “Very much worse”.~Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response"|Visit 3 to Visit 8 (Week 6)|Modified Intent to Treat Population = all randomized subjects who took at least one dose of randomized study drug and have a valid baseline assessment and at least 1 valid post baseline assessment.|||Participants|||Count of Participants
1306141|NCT02777931|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score|"The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = “Never or rarely” to 3 = “Very often”.~The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value."|Baseline to Visit 8 (Week 6)|Modified Intent to Treat Population = all randomized subjects who took at least one dose of randomized study drug and have a valid baseline assessment and at least 1 valid post baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1306144|NCT02777268|Secondary|Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h||||Hours||Standard Deviation|Median
1306145|NCT02777268|Secondary|Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1306146|NCT02777268|Primary|Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone|To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.|||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1306147|NCT02777268|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone|To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.|||Hour||Standard Deviation|Median
1306148|NCT02777268|Primary|Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone|To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1306149|NCT02777242|Primary|Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.|Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.|3 weeks||||Participants|||Count of Participants
1306150|NCT02777125|Secondary|Number of Participants Requiring Repeat Visits|Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study.|Within 7 days of initial presentation||||Participants|||Count of Participants
1306151|NCT02777125|Secondary|Number of Patients Requiring Ondansetron Dosing|Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department.|6 hours||||Participants|||Count of Participants
1306152|NCT02777125|Secondary|Number of Patients With Tachycardia After Treatment|Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance.|6 hours||||Participants|||Count of Participants
1306153|NCT02777125|Secondary|Emergency Department Length of Stay|Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition.|6 hours||||minutes||Standard Deviation|Mean
1306154|NCT02777125|Primary|Number of Participant's Admitted to the Hospital for Further Treatment|Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.|6 hours||||Participants admitted to the Hospital|||Number
1306155|NCT02774343|Secondary|Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use|A modified Timeline Followback (TLFB) procedure was used to assess cocaine use. The mean percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly.|Weeks 1-12||||percentage of self-reports||Standard Deviation|Mean
1306156|NCT02774343|Secondary|Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive|The mean percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly.|Weeks 1-12||||percentage of urine samples||Standard Deviation|Mean
1306157|NCT02774343|Secondary|Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events||week 12||||Participants|||Count of Participants
1306158|NCT02774343|Secondary|Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects||week 12||||Participants|||Count of Participants
1306159|NCT02774343|Secondary|Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken|A modified Timeline Followback (TLFB) procedure was used for self-reports. The percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly.|weeks 1 - 12||||percentage of self-reports||Standard Error|Mean
1306160|NCT02774343|Secondary|Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive|Riboflavin was added to pill capsules as a marker of medication compliance. The percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly.|weeks 1 - 12||||percentage of urine samples||Standard Error|Mean
1306161|NCT02774343|Secondary|Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study||week 12||||Participants|||Count of Participants
1306201|NCT02770625|Secondary|Liver Volume||from baseline to Week 24||||Milliliters||Standard Deviation|Mean
1306202|NCT02770625|Secondary|Spleen Volume||from baseline to Week 24||||Milliliters||Standard Deviation|Mean
1306203|NCT02770625|Secondary|Platelet Counts [10^3 Platelets/uL]||from baseline to Week 24||||10^3 platelets/uL||Standard Deviation|Mean
1306204|NCT02770625|Primary|The Difference in Hemoglobin Concentration [g/dL]||from baseline to Week 24||||g/dL||Standard Deviation|Mean
1306162|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
1306163|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
1306164|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
1306165|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
1306166|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
1306167|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
1306168|NCT02774343|Primary|Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving|Every two weeks, visual analog scale ratings of craving (VAS craving) consisting of 100 mm line, anchored by 0 “not at all” and 100 “extremely,” were used to assess cocaine craving right now, craving on average in the past week, and the worst craving in the past week. Data were analyzed as a total score, which is the sum of the scores for the three questions.|Baseline, week 2, week 4, week 6, week 8, week 10, week 12||||units on a scale||Standard Deviation|Mean
1306169|NCT02774343|Primary|Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS)|The obsessive compulsive drug use scale (OCDUS) measures the level of craving for cocaine during the past week. The mean score over all time points is reported in this outcome measure (i.e., a summary score is reported). The scale was administered once weekly. It consists of 12 items. The score range is 0 to 60, and higher scores indicates greater craving.|Weeks 1-12||||units on a scale||Standard Deviation|Mean
1306170|NCT02774343|Primary|Craving as Assessed by the Brief Substance Craving Scale (BSCS)|The brief substance craving scale (BSCS) is a 16-item, self-report instrument assesses craving for cocaine and other substances of abuse over a 24 hour period. The domains of intensity, frequency, and duration are recorded on a five-point Likert scale. The range of scores for each domain is 0 to 4, and the total score is the sum of all three domains. The total score range is 0 to 12, and higher scores indicate higher craving (worse outcome.)|Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12||||units on a scale||Standard Deviation|Mean
1306171|NCT02774278|Secondary|Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST|Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
1306172|NCT02774278|Secondary|Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
1306173|NCT02774278|Primary|Number of KRAS Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had KRAS mutation at baseline were included in this analysis.|||participants|||Number
1306174|NCT02774278|Primary|Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had EGFR mutation at baseline were included in this analysis.|||participants|||Number
1306175|NCT02774278|Primary|Number of Differentially Expressed Genes Associated With Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Primary analysis set (PAS) included all participants who provided evaluable tissue samples and were included in the primary Affymetrix efficacy analysis.|||genes|||Number
1306176|NCT02774265|Secondary|Number of Participants With Pulmonary Embolism Events|Bases on imaging obtained for symptoms.|90 days|As per flow sheet|||Participants|||Count of Participants
1306177|NCT02774265|Secondary|Number of Participants With Deep Venous Thromboembolism|DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy.|90 days|same as flow chart|||Participants|||Count of Participants
1306178|NCT02774265|Primary|Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.|Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed|90 days|As described in Participant Flow|||Participants|||Count of Participants
1306179|NCT02774148|Secondary|Hospital Stay|Length of hospital stay will be compared between the two groups.|2 weeks|No analyses complete due to early termination.||||||
1306180|NCT02774148|Secondary|Distance Ambulated|The distance ambulated will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
1306181|NCT02774148|Secondary|Timing of First Day of Ambulation.|The timing of the first day of ambulation will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
1306182|NCT02774148|Secondary|The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.|The amount of opioid pain medication a patient receives will be recorded and the Morphine equivalents will be determined by an opioid dose calculator. The morphine equivalents will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
1306183|NCT02774148|Primary|Pain Score|Pain scores will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
1306237|NCT02766283|Secondary|Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
1306184|NCT02773758|Secondary|Change From Baseline in Tactile Threshold at Day 7 and Day 14|A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.|Baseline, Day 7 and Day 14|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.|||gram (g)||Standard Deviation|Mean
1306185|NCT02773758|Secondary|Change From Baseline in Schiff Sensitivity Score at Day 7|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant’s response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 7|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1306186|NCT02773758|Primary|Change From Baseline in Schiff Sensitivity Score at Day 14|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant’s response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 14|Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1306187|NCT02773446|Secondary|Immune Response to Challenge|Antibody in Lymphocyte Supernatant (ALS) Immunoglobin G (IgG) (CS6) coli surface antigen 6 Immunoglobin G (IgG) heat labile Toxin (LT) Immunoglobin G (IgG) (LPS) Lipopolysaccharide Immunoglobin A (IgA) (CS6) coli surface antigen 6 Immunoglobin A (IgA) heat labile Toxin (LT) Immunoglobin A (IgG) (LPS) Lipopolysaccharide|6 days post challenge|samples for ALS IgG and IgA were unavailable for 1 participant in cohort 2 group A Samples for ALS IgG CS6, LT and IgA CS6 were unavailable for 1 participant in cohort 2 group B|||participants|||Number
1306188|NCT02773446|Secondary|Immune Response to Challenge (Serology)||28 days post challenge||||Participants|||Count of Participants
1306189|NCT02773446|Primary|Number of Participants With Safety -Solicited Symptoms Unrelated to Challenge Administration|Safety solicited symptoms unrelated to challenge administration (vomiting, abdominal pain, bloating, lightheadedness, anorexia, generalized myalgia, arthralgias, abdominal cramping, constipation, nausea, malaise, headache, flatulence)|6 days post-challenge||||Participants|||Count of Participants
1306190|NCT02773446|Primary|Moderate-severe Diarrhea in Subjects Receiving Homologous Rechallenge|"Moderate-severe diarrhea post-challenge defined as~Moderate diarrhea: 4 to 5 loose/liquid stools or 401-800g of loose/liquid stool in any 24- hour period~Severe diarrhea: greater than or equal to 6 loose/liquid stools or greater than 800 g of loose/liquid stool in any 24-hour period"|7 days post-challenge||||Participants|||Count of Participants
1306191|NCT02773446|Primary|Moderate-severe Diarrhea|"Moderate-severe diarrhea post challenge defined as~moderate diarrhea: 4 to 5 loose/liquid stools or 401-800 of loose/liquid stool in any 24-hour period~Severe diarrhea greater than or equal to 6 loose/liquid stools or greater than 800 g of loose/liquid stools in any 24-hour period"|5 days post challenge (Cohort 1 and Cohort 2 group B) 7 days post challenge (Cohort 2 Group A)||||Participants|||Count of Participants
1306192|NCT02773446|Primary|Number of Participants With Safety- Solicited Symptoms Related to Challenge Administration|Solicited symptoms (vomiting, abdominal pain, bloating, lightheadedness, anorexia, generalized myalgia, arthralgias, abdominal cramping, constipation, nausea, malaise, headache, flatulence)|6 days post-challenge||||Participants|||Count of Participants
1306193|NCT02772666|Primary|Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)|"The instrument illuminated the eyes alternatively and took images and recorded pupillary reflex to this light stimulation.~All of 44 patients were examined with two methods, SFT and O Glass. SFT method: The well known manual method to diagnose RAPD. O glass method:The device consists of camera and light sources.The red light was on and off for a 5 second interval. Then the white light was on for right eye and 3 seconds later the system captured an image. After 0.5 second the right light was off and the left light turned on, 3 seconds later the image was captured. The images were processed and analyzed using computerized software."|up to 6 months||||participants|||Number
1306194|NCT02770625|Other Pre-specified|Assessment of AEs, Vital Signs, Physical Examination, and Electrocardiogram (ECG)||Screening to Visit14 (Week 26)|||||||
1306195|NCT02770625|Secondary|Change in Bone Mineral Density||from baseline to Week 24||||g/cm^2||Standard Deviation|Mean
1306196|NCT02770625|Secondary|Skeletal Status Improvement|The number of participant who have the skeletal status diagnosed as Osteosclerosis|from baseline to Week 24||||Participants|||Count of Participants
1306197|NCT02770625|Secondary|Acid Phosphatase (ACP) Level (U/L)||from baseline to Week 24||||U/L||Standard Deviation|Mean
1306198|NCT02770625|Secondary|Chemokine Ligand (CCL-18) Level [ng/mL]||from baseline to Week 24||||ng/mL||Standard Deviation|Mean
1306199|NCT02770625|Secondary|Chitotriosidase Level (Nmol/mL/hr)||from baseline to Week 24||||nmol/mL/hr||Standard Deviation|Mean
1306200|NCT02770625|Secondary|Angiotensin-converting Enzyme Level||from baseline to Week 24||||U/L||Standard Deviation|Mean
1306205|NCT02770248|Secondary|Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4|IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
1306206|NCT02770248|Secondary|Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4|IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
1306207|NCT02770248|Secondary|Least Squares Mean Change From Baseline in Daytime IOP at Week 4|IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
1306208|NCT02770248|Primary|Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4|IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
1306209|NCT02769858|Primary|Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks|Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin|After five weeks of light therapy||||minutes||Standard Deviation|Mean
1306210|NCT02769858|Primary|Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks|Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression.|After five weeks of light therapy||||EPDS score||Standard Deviation|Mean
1306211|NCT02769858|Primary|Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks|Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression|After five weeks of light therapy||||SIGH-SAD score||Standard Deviation|Mean
1306212|NCT02769442|Secondary|Number of Participants With Blood Visible at Site of Insertion|Compare the frequency of bleeding near the insertion site|Within first minute of IV access||||participants|||Number
1306213|NCT02769442|Primary|Number of Participants With First-skin Puncture Success|"First attempt success, defined as one skin puncture (redirection permitted) which allows for completion of a blood draw and/or flush without extravasation.~Gauge size~Patient prior history of difficult IV access~Operator type (ED Technician/Registered Nurse/Physician Assistant/Nurse Practitioner/Resident/Attending)~Operator years of experience with IV access~Type of catheter used"|Within first minute of IV access||||Participants|||Count of Participants
1306214|NCT02768194|Secondary|Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application|Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded|Baseline, Day 1, 4, and 10|PP Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations.|||Score on a scale||Standard Deviation|Mean
1306215|NCT02768194|Primary|Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application|Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded|Baseline and Day 8|Per protocol (PP) Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations.|||Score on a scale||Standard Deviation|Mean
1306216|NCT02767843|Secondary|Complete Response|snoring for < 5% of total sleep tim|one night|||||||
1306217|NCT02767843|Primary|Adverse Events|all adverse events|one night|All four participants were analyzed for adverse events. No participants could be analyzed for efficacy outcomes because of technical difficulties with the measurement instruments.|||Participants|||Count of Participants
1306218|NCT02767843|Primary|Response|snoring decreased by <50% from baseline|one night|Technical problems with the measurement instruments meant that no analyzable data were collected.||||||
1306238|NCT02766283|Primary|Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting||Up to one year after iodinated contrast material (ICM) exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
1306239|NCT02766244|Primary|Perfusion of Burned Area|Perfusion as measured by ICG Fluorescence|5 days||||% perfusion compared to normal skin|||Number
1306240|NCT02765269|Secondary|Karnofsky Performance Score Evaluation|"The Karnofsky performance score runs from 100 to 0, where 100 is perfect health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group."|2 weeks||||scores on a scale||Standard Deviation|Mean
1356019|NCT01722266|Secondary|Change in Body Weight From Baseline at Week 12||Baseline and 12 weeks||||Kg||Standard Error|Mean
1306219|NCT02767765|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4|FACT-An comprises of 4 subscales of 27-item (FACT-General scale [FACT-G]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188.|Baseline, Week 4|"All enrolled participants who completed the questionnaire at baseline were included in the analysis. Here, n represents number of participants evaluable for the specified category."|||units on a scale||Standard Deviation|Mean
1306220|NCT02767765|Secondary|Percentage of Participants Who Required Transfusion||Baseline, Week 2, Week 4|ITT analysis population|||percentage of participants|||Number
1306221|NCT02767765|Secondary|Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment|"No Response to treatment after 4 weeks was defined as meeting any of the following criteria: <1 g/dL increase in hemoglobin level or hemoglobin level <8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of >1 g/dL but required transfusion then the participant is considered as Non- Responder."|Week 4|ITT analysis population|||percentage of participants|||Number
1306222|NCT02767765|Secondary|Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment|Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes >40000 per microliter or >25% increase in soluble transferrin receptor or >0.5 g/dL increase in hemoglobin level.|Week 2|ITT analysis population|||percentage of participants|||Number
1306223|NCT02767765|Secondary|Time to Response|Time to response was defined as the time between the start of treatment and the increase in hemoglobin level >1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.|Baseline up to Week 4|ITT analysis population|||days||95% Confidence Interval|Median
1306224|NCT02767765|Primary|Percentage of Participants With Response to Treatment|Response to treatment was defined as an increase of greater than (>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.|Week 4|The intent-to-treat (ITT) analysis population included all enrolled participants who received study medication for at least 2 weeks.|||percentage of participants|||Number
1306225|NCT02766400|Primary|Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time.~The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses."|Baseline, rehab discharge, month 3, month 6, month 12||||units on a scale||Standard Error|Mean
1306226|NCT02766283|Secondary|The Duration of Hypothyroidism Episode in the “Probable Iodine Induced” Category|Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.|Up to one year after ICM exposure (828 person years)|Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.|||Days|||Number
1306227|NCT02766283|Secondary|The Duration of Hypothyroidism Episode in the “Probable Iodine Induced” Category|Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.|Up to one year after ICM exposure (828 person years)|Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.|||Months|||Number
1306228|NCT02766283|Secondary|The Duration of Hypothyroidism Episode in the “Probable Iodine Induced” Category|Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below.|Up to one year after ICM exposure (828 person years)|Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.|||Months|||Number
1306229|NCT02766283|Secondary|Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism||Up to one year after ICM exposure (828 person years)|Final Cohort|||Days||Standard Deviation|Mean
1306230|NCT02766283|Secondary|Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Days||Standard Deviation|Mean
1306231|NCT02766283|Secondary|Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
1306232|NCT02766283|Secondary|Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
1306233|NCT02766283|Secondary|Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
1306234|NCT02766283|Secondary|Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort||Prior to first examination|Final Cohort|||Participants|||Count of Participants
1306235|NCT02766283|Secondary|Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort||Within a range of ±360 days of the first examination|Final Cohort|||Kilograms||Standard Deviation|Mean
1306236|NCT02766283|Secondary|Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort||At first examination|Final Cohort|||Years||Standard Deviation|Mean
1328419|NCT02127281|Secondary|Knee Flexion|Mean knee flexion (degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Standard Deviation|Mean
1306242|NCT02765269|Secondary|Pain Management|"Numerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where 0 means no pain and 10 means pain as bad as it could be. Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period."|2 weeks||||scores on a scale||Standard Deviation|Mean
1306243|NCT02765269|Primary|Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients|The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.|2 weeks||||pain assessments per day||Standard Deviation|Mean
1306244|NCT02764970|Secondary|Motion Artifacts|Counted linear misalignments in the ap projection|intraoperative||||linear misalignments in the ap projectio||Standard Deviation|Mean
1306245|NCT02764970|Secondary|Radiation Dose|as calculated in mSv|intraoperative||||mSv||Standard Deviation|Mean
1306246|NCT02764970|Secondary|Number of Participants With Use of i.v. Betablocker|measured in mg metoprolol used|time from first ECG in the CT-room to start of CT scan (average of 10 minutes)||||participants|||Number
1306247|NCT02764970|Primary|Heart Rate|number of beats per minute|intraoperative||||beats per minute||Standard Deviation|Mean
1306248|NCT02764697|Primary|Number of Participants With Clinically Significant Improvement of Macular Edema|Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns|12 weeks|0|||Participants|||Count of Participants
1306249|NCT02764697|Primary|Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography|Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale|12 Weeks||||Participants|||Count of Participants
1306250|NCT02763189|Secondary|Performance Score|The performance score is obtained form the performance Score Sheet that includes 15 actions, 1 point is given for each completed action. The minimum score is 0, the maximum score is 15. Higher scores relate to better performance.|immediately after the procedure||||units on a scale||Full Range|Mean
1306251|NCT02763189|Primary|Apnea Time|Apnea time was measured in seconds from the time the ventilator was disconnected from the original endotracheal tube to the time the ventilator was connected to the new endotracheal tube immediately after procedure.|immediately after the procedure||||seconds||Full Range|Mean
1306252|NCT02762370|Other Pre-specified|Change in Average Blood Glucose From Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48 for FX006 32 mg Relative to TCA IR 40 mg.||Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48||||mg/dL||Standard Error|Least Squares Mean
1306253|NCT02762370|Other Pre-specified|Change From Baseline for Maximum Blood Glucose: Baseline Average Blood Glucose (Hour −72 to Hour −1) to Maximum Blood Glucose (Hour 1 to Hour 72) for FX006 32 mg Relative to TCA IR 40 mg||Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72||||mg/dL||Standard Error|Least Squares Mean
1306254|NCT02762370|Other Pre-specified|Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl||Baseline to Days 1-2||||Percentage of time|||Number
1306255|NCT02762370|Secondary|Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR||Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)||||hr*mg/dL||Standard Error|Least Squares Mean
1306256|NCT02762370|Secondary|Glycemic Variability Coeffecient of Variation (CV)|The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average.|Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)||||mg/dL||Standard Error|Least Squares Mean
1306257|NCT02762370|Secondary|Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl|The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average.|Baseline to Days 1-3||||Percentage of time|||Number
1306258|NCT02762370|Primary|Change From Baseline for Average Blood Glucose (mg/dL)|Average blood glucose was analyzed with a mixed model for repeated measures (MMRM)|Baseline and 72 Hours post intra-articular (IA) injection||||mg/dL||Standard Error|Least Squares Mean
1306259|NCT02761733|Primary|Communication Satisfaction Questionnaire|Communication satisfaction was measured utilizing a modified version of a 19-item measure of communication patterns between physicians and their clients (Campbell et al., 2007). Thirteen items focusing on the client’s satisfaction with communication with their provider and their engagement in treatment were measured on a 7-point scale (strongly agree, agree, agree somewhat, undecided, disagree somewhat, disagree, strongly disagree). Example items included “My provider checks to be sure that I understand everything” or “My provider involves me in decisions as much as I want.” Total average scores range from 1 to 7 with higher scores indicating better communication satisfaction. Analyses will examine change in Satisfaction Questionnaire scores from pre- to post-intervention.|Change in scores on the Communication Satisfaction Questionnaire from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
1309300|NCT02613871|Secondary|HBsAg Level Change From Baseline at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108||Baseline; Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108|||||||
1306260|NCT02761733|Primary|Working Alliance Inventory|The Working Alliance Inventory measures the perception of therapeutic alliance in a clinical dyad during the process of developing a relationship required for effective psychotherapy. The current study utilized the client version of the Working Alliance Inventory included 7 items measured on a 7-point scale (never, rarely, occasionally, sometimes, often, very often, always). Example items included “I am confident in my provider’s ability to help me” and “My provider and I trust one another.” The Working Alliance Inventory total average score ranges from 1 to 7, with high scores indicating a more positive outcome. Analyses will examine change in patient-reported Working Alliance Inventory scores from pre- to post-intervention.|Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
1306261|NCT02761733|Primary|Shared Decision Making Questionnaire|A 6-item modified version of the Shared Decision Making Questionnaire (SDM-Q-9) 46 was utilized to assess client reports about the degree to which their provider involved them in understanding and making a treatment decision. Examples items included “My provider discussed the advantages and disadvantages of options and strategies” or “My provider helped me understand all the information” measured on a 6-point scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, and completely agree). The total average score ranges from 1 to 6 with higher scores indicating a better outcome of greater shared decision making. Analyses will examine change in Shared Decision Making Questionnaire scores from pre- to post-intervention.|Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
1306262|NCT02761733|Primary|Outcome Rating Scale (ORS)|The Outcome Rating Scale (ORS) was utilized as a repeated measure of general therapy outcomes and quality of life changes during the course of therapy. The Outcome Rating Scale includes a visual analog scale (a horizontal line on which the participants marks how well they are doing within the last week from low to high) that records four questions about general well-being, personal well-being, close relationships, and work/school/friend relationships. Physical marks for each of four domains on the visual analog scale are measured by research team members with a ruler and converted to a score from 1 to 100. The four items are then averaged for an overall therapy outcome score. The total averaged ORS score ranges from 1 to 100, with higher scores indicating a better outcome. Analyses will examine treatment progress via change in ORS scores from pre- to post-intervention.|Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
1306263|NCT02761733|Primary|Short Form Health Survey-12 (SF-12) Mental Symptoms|The mental health subscale (MCS-12; Mental Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess mental aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The physical health subscale of the SF-12 was utilized as a key client functioning outcome in the current study. The aggregate MCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). MCS scores in the present study ranged from 9.6 to 72.0, with higher values indicating better physical health.|Change in scores on the SF-12 from Baseline to 24 month follow-up Description: The Health Survey Short Form-12 (SF-12) includes 12 items that assess for physical and mental aspects of health and well-being.|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
1306264|NCT02761733|Primary|Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale|The physical health subscale (PCS-12; Physical Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess physical aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The aggregate PCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). PCS scores in the present study ranged from 13.2 to 65.6, with higher values indicating better physical health.|Change in scores on the SF-12 from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
1306265|NCT02761642|Secondary|Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores|FACT-An comprised of 2 subscales (‘Fatigue’ and ‘Non-fatigue’) of 20-items. All questions were rated on a scale from 0 to 4, where higher scores indicate improved quality of life. The ‘Fatigue’ subscale consists of 13 questions with score range from 0-52; ‘Non-fatigue’ subscale consists of 7 questions with score range from 0-28. Total FACT-An score was transformed to a 0-100 scale (instead of 0-80 scale) to get better perception of the participant’s quality of life indicator.|Baseline, Week 12|"Safety population. Here, “Number of Participants Analyzed” represents number of participants evaluable for this outcome measure and Number Analyzed represents number of participants evaluable at specified time points."|||units on a scale||95% Confidence Interval|Mean
1356020|NCT01722266|Secondary|Change in HbA1c From Baseline at 12 Weeks||Baseline and 12 Weeks||||Percent||Standard Error|Mean
1306266|NCT02761642|Secondary|Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL|Time to increase in hemoglobin level by at least 1 g/dL was defined as the time between the start of treatment and an increase in hemoglobin level by at least 1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.|Baseline up to Week 12|Safety population|||days||95% Confidence Interval|Mean
1306267|NCT02761642|Secondary|Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks||Baseline, Week 4|Safety population|||percentage of participants||95% Confidence Interval|Number
1306268|NCT02761642|Secondary|Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment||Baseline, Week 12|Safety population|||g/dL||95% Confidence Interval|Mean
1306269|NCT02761642|Secondary|Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline|Participants were distributed into 2 subgroups. One subgroup contained participants who had spent <6 months on chemotherapy and other subgroup contained participants who had spent 6 months or more on chemotherapy.|Baseline, Week 12|"Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category."|||g/dL||95% Confidence Interval|Mean
1306270|NCT02761642|Secondary|Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline|Participants were distributed into 3 subgroups. First subgroup contained participants who received adjuvant chemotherapy. Second subgroup contained participants who received metastatic 1st or 2nd line chemotherapy. Third subgroup contained participants who received metastatic 3rd line chemotherapy.|Baseline, Week 12|"Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category."|||g/dL||95% Confidence Interval|Mean
1306271|NCT02761642|Secondary|Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline|Participants were distributed into 2 subgroups. One subgroup contained participants who had hemoglobin (Hb) level less than (<) 10 g/dL and other subgroup contained participants who had hemoglobin level greater than or equal to (≥) 10 g/dL but <11 g/dL (10≤ Hb <11 g/dL).|Baseline, Week 12|"Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category."|||g/dL||95% Confidence Interval|Mean
1306272|NCT02761642|Primary|Percentage of Participants With Response to Treatment Based on Hemoglobin Levels|Response was defined as increase of hemoglobin levels by at least 2 grams per deciliter (g/dL) as compared to baseline or the achievement of hemoglobin level of 12 g/dL after 12 weeks of treatment in the absence of red blood cells transfusion.|Week 12|Safety population|||percentage of participants||95% Confidence Interval|Number
1306273|NCT02761629|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories|ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), >1-2 Upper Normal Limit (ULN), >2-5 ULN, >5-10 ULN, and >10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96|Safety analysis population: all randomized participants who receive >/=1 dose of any study medication and had >/=1 post-baseline safety assessment. Number of participants analyzed= overall participants who were evaluable for this outcome at any time-point and “n” = participants who were evaluable at specified time-point; for each arm, respectively.|||percentage of participants|||Number
1306274|NCT02761629|Secondary|Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."|||Ratio||Standard Deviation|Mean
1306275|NCT02761629|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
1306276|NCT02761629|Secondary|Serum Human Immunodeficiency Virus (HIV) RNA Levels|HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, 48, and 72; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, 72, and 96|"ITT analysis population. Here, number of participants analyzed = participants with detectable HIV RNA levels and n = participants with detectable HIV RNA levels at specified time-point; for each arm, respectively."|||Log10 copies per milliliter||Standard Deviation|Mean
1306277|NCT02761629|Secondary|Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment|SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm).|24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|ITT analysis population. Here, number of participants analyzed signifies participants with undetectable HCV RNA at the end of treatment.|||percentage of participants|||Number
1306278|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders.|12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 84 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|ITT analysis population|||percentage of participants||95% Confidence Interval|Number
1306279|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for ‘Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks’ arm and Week 72 for ‘Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks’ arm).|For “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm: Weeks 4, 12, 24, and 48; for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm: Weeks 4, 12, 24, 48, and 72|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for this outcome at specified time-point; for each arm, respectively."|||percentage of participants||95% Confidence Interval|Number
1306280|NCT02761629|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter [IU/mL]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.|24 weeks after completion of study treatment (up to Week 72 for “Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks” arm and up to Week 96 for “Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks” arm)|Intent-to-treat (ITT) analysis population|||percentage of participants||95% Confidence Interval|Number
1306281|NCT02760810|Secondary|Tear Film PH|Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.|1-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||PH value||Standard Deviation|Mean
1306282|NCT02760810|Secondary|Tear Film Osmolarity|Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.|1-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||mOsm/L|Eyes|Standard Deviation|Mean
1306283|NCT02760810|Primary|Tear Film Osmolarity|Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing|2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||mOsm/L|Eyes|Standard Deviation|Mean
1306284|NCT02760654|Secondary|Change in PROMIS Pain Interference 4a Scores at 8 Weeks|The PROMIS Pain Interference 4a is scored on a scale of 41.6 to 75.6, with a score of 41.6 meaning little or no interference with daily activities due to pain severity, and a score of 75.6 meaning a high degree of interference with daily activities due to pain severity.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
1306285|NCT02760654|Secondary|Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks|The European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy contains three subscales: Sensory, Motor, and Autonomic. Each subscale is scored on a scale of 0 - 100, with a score of 0 representing no neuropathy symptoms and functional impairment due to neuropathy, and a score of 100 represents severe neuropathy symptoms and functional impairment due to neuropathy. Only the Sensory and Motor subscales were used in this current study.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
1306286|NCT02760654|Secondary|Adapted Acceptability E-Scale|The Adapted Acceptability E- Scale contains 7 items that are scored on a 1 - 5 scale, with a score of 1 representing low ratings of acceptability and satisfaction with the online self management program, and a score of 5 representing high ratings of acceptability and satisfaction with the online self management program. This measure was only administered to individuals participating in the online self management program.|8 week|Only 19 in the people in the online self-management group of the 23 that completed the study actually completed the information for this measure. Thus only 19 are analyzed. No participants in the control group were administered this measure because the questions pertained to the acceptability and satisfaction of the online self management program.|||units on a scale||Standard Deviation|Mean
1306287|NCT02760654|Secondary|Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks|The 0 - 10 Average Pain Intensity Numerical Rating Scale was scored on a scale of 0 - 10, with a score of 0 meaning no pain, and a score of 10 meaning worst pain imaginable.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
1306288|NCT02760654|Secondary|Patient Global Impression of Change|The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.|8 week|Only 19 in the people in the online self-management group and 22 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 22 respectively are analyzed.|||Participants|||Count of Participants
1306305|NCT02760602|Secondary|Change From Baseline on the Neuropsychiatric Inventory (NPI)|The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306289|NCT02760654|Secondary|Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks|The PROMIS Short Form Sleep-Related Impairment 8a is scored on a scale of 30.0 to 80.1 with a score of 30.0 meaning no sleep-related impairment and a score of 80.1 meaning a high degree of impairment in daily activities due to poor sleep.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
1306290|NCT02760654|Secondary|Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks|The PROMIS Short Form Fatigue 4a is scored on a scale of 33.7 to 75.8, with a score of 33.7 meaning no fatigue and a score of 75.8 meaning high fatigue.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
1306291|NCT02760654|Secondary|PROMIS Short Form Anxiety 4a|The PROMIS Short Form Anxiety 4a is scored on a scale of 40.3 - 81.6, with a score of 40.3 meaning no anxiety and a score of 81.6 meaning high anxiety.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
1306292|NCT02760654|Secondary|Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks|The PROMIS short form emotional distress depression 4a Scores are measured on a scale whose lowest possible score is 41.0 and highest is 79.4 where 41 is no emotional distress and 79.4 is extreme distress.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
1306293|NCT02760654|Primary|Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks|Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.|Baseline to 8 weeks|Only 19 people in each arm out of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 are analyzed.|||units on a scale||Standard Deviation|Mean
1306294|NCT02760602|Secondary|Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET|Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306295|NCT02760602|Secondary|Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins|Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306296|NCT02760602|Secondary|Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)|Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306297|NCT02760602|Secondary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)|MRI will be used to assess the effect of treatment on rate of whole brain volume.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306298|NCT02760602|Secondary|Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab|Concentration of amino acid peptide known as Aβ 1-42 in plasma.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306299|NCT02760602|Secondary|Change From Baseline on the Quality of Life in Alzheimer’s Disease Scale (QoL-AD)|QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306300|NCT02760602|Secondary|Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306301|NCT02760602|Secondary|Change From Baseline on the Resource Utilization in Dementia–Lite (RUD-Lite)|RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306302|NCT02760602|Secondary|Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)|The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306303|NCT02760602|Secondary|Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306304|NCT02760602|Secondary|Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306359|NCT02756637|Primary|Overall Survival|Number of participants who survived at 26 years are reported.|26 years||||participants|||Number
1306306|NCT02760602|Secondary|Change From Baseline on the Functional Activities Questionnaire (FAQ)|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant’s ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306307|NCT02760602|Secondary|Change From Baseline on the Montreal Cognitive Assessment (MoCA)|The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306308|NCT02760602|Secondary|Change From Baseline on the Mini Mental Status Examination (MMSE)|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306309|NCT02760602|Secondary|Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)|The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306310|NCT02760602|Primary|Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score|ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
1306311|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 15-17)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 15.Clarity of vision during daily activities 16.Clarity of vision in dim or low lighting conditions 17. Clarity of visions when driving at night."|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
1306312|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 11-14)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 11.I was very satisfied with my distance vision when i first put these lenses in my eyes. 12.I was very satisfied by the clarity of my vision at the end of the day 13.I was satisfied with the quality of my vision at night 14.With these lenses, I felt very confident to drive at night"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
1306313|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 6-10)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)6. Comfort at the end of the day 7. They remained comfortable from the moment I put them in until the moment I took them out 8.Comfort from activity to activity 9. Comfort across different environments 10.Comfort while working on a computer"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
1306314|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 1-5)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)1.These Lenses Were Very Comfortable At The End Of The Day 2.The Comfort of these lenses decreased throughout the day 3. The lenses were very comfortable from the time I got up to the time I went to bed 4. Overall Comfort 5. Comfort throughout the Day"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
1306360|NCT02756624|Primary|Number of Treatment Related Adverse Events|Adverse events will be measured through study completion|up to 12 weeks|Intent to Treat (ITT)|||adverse events|||Number
1306315|NCT02759692|Primary|Overall Quality of Vision|Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale|Observations|Standard Deviation|Mean
1306316|NCT02759692|Primary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale|Observations|Standard Deviation|Mean
1306317|NCT02759562|Secondary|Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set|||percent change||Standard Deviation|Mean
1306318|NCT02759562|Secondary|Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set|||percent change||Standard Deviation|Mean
1306319|NCT02759562|Secondary|Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set|||percent||Standard Deviation|Mean
1306320|NCT02759562|Primary|Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set: all randomized participants who took at least 1 dose of study drug.|||percent||Standard Deviation|Mean
1306321|NCT02759471|Primary|Lens Preference/Acceptability|Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).|baseline, 2 weeks, 1 month||||participants|||Number
1306322|NCT02759471|Primary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.|||units on a scale||Standard Deviation|Mean
1306323|NCT02759471|Primary|Lens Fit - Corneal Coverage|Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.|||participants|||Number
1306324|NCT02759471|Primary|Lens Fit - Centration|Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.|||participants|||Number
1306325|NCT02759315|Primary|Percentage of Participants With ≥1 Events of Clinical Interest (ECIs)|The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >500 IU/L; 3) first instance of ALT or AST >3x nadir and >3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2; or 4) first instance of serum creatinine >1.3x ULN and elevated from baseline.|Up to Week 14 (up to 2 weeks after completing study therapy)|All participants who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
1306326|NCT02759315|Secondary|Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12|The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|12 weeks after the end of all study therapy (24 weeks)|All participants who received ≥1 dose of study treatment, and who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, and who had baseline sequencing data available, are included.|||Percentage of Participants|||Number
1306327|NCT02759315|Secondary|Percentage of Participants With Virologic Failure (VF)|The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA < LLOQ while on treatment); 2) rebound (>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being <LLOQ on treatment); or 4) relapse (HCV RNA ≥LLOQ after end of all study therapy after being undetectable at end of treatment); virologic failure could occur either on-treatment or relapse post-treatment. For VF, participants with GT1 infection were separated into GT1a or GT1b infection|12 weeks after the end of all study therapy (24 weeks)|All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.|||Percentage of Participants|||Number
1306328|NCT02759315|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection.|Week 36 (24 weeks after completing study therapy)|All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.|||Percentage of Participants|||Number
1306329|NCT02759315|Primary|Percentage of Participants Withdrawing From Study Therapy Due to an AE|The percentage of participants discontinuing from study therapy during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to Week 12|All participants who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
1306330|NCT02759315|Primary|Percentage of Participants With ≥1 Adverse Events (AEs)|The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to Week 14 (up to 2 weeks after completing study therapy)|All participants who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
1306331|NCT02759315|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma < lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|Week 24 (12 weeks after completing study therapy)|All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.|||Percentage of Participants||95% Confidence Interval|Number
1306332|NCT02758613|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib|Area under the concentration versus time curve from zero to infinity (AUC0-inf) during single dose and area under the concentration versus time curve (AUCtau,ss) during multiple dose of baricitinib at steady state.|Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose|All randomized participants who received at least 1 dose of baricitinib and had evaluable PK data.|||nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1306333|NCT02758613|Secondary|Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib|Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing.|Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose|All randomized participants who received at least one dose of baricitinib and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1306334|NCT02758613|Primary|Number of Participants With One or More Clinically Significant Event(s)|Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Baseline through Study Completion (up to Day 20)|All randomized participants who received at least one dose of study drug and experienced clinically significant event.|||Participants|||Count of Participants
1306335|NCT02758210|Secondary|Number of Participants Reporting Clinical Symptoms While Using a Tablet|Participants were asked to report any clinical symptoms that they experienced when using the tablet.|Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)||||Participants|||Count of Participants
1306336|NCT02758210|Secondary|Number of Participants Reporting Clinical Symptoms While Using a Smart Phone|Participants were asked to report any clinical symptoms that they experienced when using the smart phone.|Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)||||Participants|||Count of Participants
1306337|NCT02758210|Primary|Device Response While Using a Tablet, Assessed by Ventricular Pacing|Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.|Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)||||millivolts (mV)||Standard Deviation|Mean
1306338|NCT02758210|Primary|Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone|Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.|Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)||||Participants|||Count of Participants
1306339|NCT02758210|Primary|Number of Participants Experiencing Asynchronous Pacing While Using a Tablet|Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.|Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)||||Participants|||Count of Participants
1306525|NCT02750501|Other Pre-specified|GI Symptoms|GI symptoms recorded in GI diaries by subject and/or caregiver.|Observation, Baseline and RELiZORB Treatment periods (Day -14 to Day 90): 104 days with additional 30 days of follow up.|All subjects who entered the RELiZORB Treatment Period and received at least one treatment with RELiZORB.|||Participants|||Count of Participants
1306340|NCT02758210|Primary|Device Response Assessed by Asynchronous Pacing When Using a Smart Phone|Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.|Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)||||ohms||Standard Deviation|Mean
1306341|NCT02758171|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"This outcome measure presents area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for (area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1306342|NCT02758171|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"This outcome measure presents area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 extrapolated to infinity.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-infinity (area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 extrapolated to infinity)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1306343|NCT02758171|Primary|Cmax (Maximum Measured Concentration of Linagliptin Analyte in Plasma)|"This outcome measure presents maximum measured concentration of Linagliptin analyte in plasma.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for Cmax (maximum measured concentration of Linagliptin analyte in plasma)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1306344|NCT02758171|Primary|Cmax (Maximum Measured Concentration of Empagliflozin Analyte in Plasma)|"This outcome measure presents maximum measured concentration of Empagliflozin analyte in plasma.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for Cmax (maximum measured concentration of Empagliflozin analyte in plasma)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1306345|NCT02758171|Primary|AUC0-72 (Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours)|"This outcome measure presents area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-72 (area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1306346|NCT02758171|Primary|AUC0-tz (Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)|"This outcome measure presents area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point.~Time frame description: The time -1:00 hour (h) was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-tz (area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1306347|NCT02757105|Secondary|Summary and Analysis of Overall Study Response Rate – mITT Population|A patient was characterized as an overall weekly responder if the patient met both the stool consistency and pain response definitions for a given week. A patient was characterized as a composite study responder if the patient met the criteria for both weekly stool consistency and pain response for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
1306348|NCT02757105|Secondary|Summary and Analysis of Overall Worst Abdominal Pain Response Rate – mITT Population|A weekly pain responder was defined as a patient who experienced a decrease in the weekly average of worst abdominal pain in the past 24 hours score ≥30% compared with baseline and no increase in the number of days per week with Type 6 or 7 stool consistency. An overall pain responder was defined as a patient who was a weekly pain responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
1306349|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP ≤ Median – mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks|Patients with Baseline CRP ≤ Median|||Participants|||Count of Participants
1306350|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP > Median – mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks|Patients with Baseline CRP > Median|||Participants|||Count of Participants
1306351|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate: Sensitivity Analysis Without Imputation for Use of Rescue Medication – mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
1306352|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate Females - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
1306353|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate Males - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
1306354|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks|Modified intent-to-treat (mITT) population analyzed included all patients who took at least one dose of double blinded study drug after randomization. In the mITT population, patients were analyzed by the treatment to which they were randomized. The population was used for a statistical analysis of efficacy endpoints.|||Participants|||Count of Participants
1306355|NCT02757053|Secondary|Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players|Establish the incidence of MRI Brain SWI and FLAIR lesions in postseason high school football players|within two months of the end of high school football season|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
1306356|NCT02757053|Secondary|Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players|Establish the expected range of MRI Brain SWI and FLAIR lesions in the general high school population at the beginning of a high school football season|within two months of the start of high school football season|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
1306357|NCT02757053|Secondary|ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap|Establish the expected range of ImPact concussion scores pre and post football season with and without the Guardian Cap|within the first two months after the high school football season ends|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
1306358|NCT02757053|Primary|MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap|MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap|within the first two months after the high school football season ends|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
1306361|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 3 (Day 22)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1306362|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 2 (Day 8)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1306363|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 1 (Day 1)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1306364|NCT02756351|Secondary|Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study.||18 hours||||Adverse Events|||Number
1306365|NCT02756351|Primary|Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.||18 hours||||fold change in log value||Standard Deviation|Mean
1306366|NCT02755935|Primary|Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear|unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise|3 months post-activation|implanted and enrolled|||percent correct||Standard Deviation|Mean
1306367|NCT02755935|Primary|Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear|Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.|3 months postactivation of the sound processor|implanted and enrolled|||percent correct||Standard Deviation|Mean
1306368|NCT02755805|Secondary|Differences in Apathy Symptoms Between Groups Over Time|"Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models.~The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point."|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
1306369|NCT02755805|Secondary|Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)|"Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models.~The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
1306370|NCT02755805|Secondary|Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)|"Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models.~The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
1306371|NCT02755805|Primary|Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models.~The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point."|Baseline, rehabilitation discharge, month 3, month 6||||units on a scale||Standard Error|Mean
1306372|NCT02755090|Primary|Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])|The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly).|Assessed 30 minutes after procedure completion.||||units on a scale||Standard Deviation|Mean
1306373|NCT02755090|Primary|Visual Analog Scale (VAS) Score for Maximum Procedural Pain|To compare women’s maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be.|Assessed immediately following completion of the procedure (as defined as removal of the speculum)||||units on a scale||Full Range|Mean
1306374|NCT02754492|Secondary|Number of Participants With Platelet Units Containing an Acceptable Platelet Yield|The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
1309493|NCT02607956|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1306375|NCT02754492|Primary|Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level|The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
1306376|NCT02754440|Secondary|Number of Participants With Platelet Units Containing an Acceptable Platelet Yield|The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
1306377|NCT02754440|Primary|Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level|The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
1306378|NCT02753699|Secondary|Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.|Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.|at Week 48|Full analysis set. In the categories, n is the number of subjects in FAS in the appropriate study group with normal ALT at visit; for Overall - at all available visits.|||percentage of participants|||Number
1306379|NCT02753699|Primary|Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48||up to 120 Weeks|Full analysis set (FAS), defined as all participants who enrolled into this study and had at least one HCV RNA assessment, unless excluded due to protocol deviations.|||percentage of participants|||Number
1306380|NCT02753413|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From vaccination (Day 0) up to study end (Day 30)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306381|NCT02753413|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period (from Day 0 to Day 29) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306382|NCT02753413|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 7-day follow-up period (from Day 0 to Day 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306383|NCT02753413|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.|During a 7-day follow-up period (from Day 0 to Day 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306384|NCT02753413|Primary|Number of Subjects With Haematology Change From Baseline by Maximum Grade|Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306385|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading|Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306526|NCT02750501|Secondary|Plasma Composition (%) Ratio of n6/n3 Fatty Acids.|Change over time in n6/n3 ratio in plasma in the ITT population|RELiZORB Treatment Period (Day 0-Day 90): 90 days||||percentage of total plasma concentration||95% Confidence Interval|Least Squares Mean
1306386|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading|Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented|||Participants|||Count of Participants
1306387|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading|Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306388|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306389|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306390|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306391|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306392|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Values.|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306393|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Values.|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1306394|NCT02753075|Secondary|Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1306395|NCT02753075|Secondary|Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1306396|NCT02753075|Secondary|Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
1306527|NCT02750501|Secondary|Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids|Change from baseline to Day 90 in n6/n3 ratio in erythrocytes|RELiZORB Treatment Period (Day 0-Day 90): 90 days||||percentage of RBC composition||95% Confidence Interval|Least Squares Mean
1306397|NCT02753075|Secondary|Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
1306398|NCT02753075|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1306399|NCT02753075|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1306400|NCT02753075|Primary|Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1306401|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 24|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306402|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 20|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306403|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 16|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306404|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 12|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306405|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 at Week 8|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306406|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 4|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306407|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 24|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306408|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week20|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306409|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 16|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306410|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 12|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and impact they had on participant's everyday life.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306411|NCT02752958|Primary|Change From Baseline in Mean Score DHEQ Section1 – Question (Q) No. 8 At Week 8|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306412|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 4|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306413|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 24|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306414|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 20|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306415|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 16|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306528|NCT02750501|Secondary|Erythrocyte Composition (%) of EPA|Changes over time in erythrocyte composition (%) for EPA in ITT population|RELiZORB Treatment Period (Day 0-Day 90): 90 days||||percentage of RBC composition||95% Confidence Interval|Least Squares Mean
1306416|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 12|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306417|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 8|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306418|NCT02752958|Primary|Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 – Question (Q) No. 7 At Week 4|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant’s sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306419|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306420|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306421|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306422|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12|: All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306423|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306529|NCT02750501|Secondary|Erythrocyte Composition (%) of DHA|Changes over time in erythrocyte composition (%) for total DHA in ITT population (n=39)|RELiZORB Treatment Period (Day 0-Day 90): 90 days|ITTT|||percentage of RBC composition||95% Confidence Interval|Least Squares Mean
1306424|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306425|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24|All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306426|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20|All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306427|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16|All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306428|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12|All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306429|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8|All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306430|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4|All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme|||Score on a scale||Standard Deviation|Mean
1306431|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme|||Score on a scale||Standard Deviation|Mean
1306468|NCT02752802|Secondary|Assessment of the Quality of Angiographic Images Between Groups|To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.|AlAll data will be collected on the day of the procedure, over an average of 12 hours.||||Images|Images||Count of Units
1306681|NCT02741713|Primary|Post-operative Axillary Pain|Post-operative ambulatory surgery subjects will be asked 6 hours after block placement about the presence of axillary pain at rest. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.|6 hours post-block.||||units on a scale||Inter-Quartile Range|Median
1306432|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306433|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3 disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me fee damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.|||Score ona scale||Standard Deviation|Mean
1306434|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306435|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306436|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306437|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I’ve been frustrated because I can’t find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a scale||Standard Deviation|Mean
1306469|NCT02752802|Primary|Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.|DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)|All data will be collected on the day of the procedure, over an average of 12 hours.||||ml||Standard Deviation|Mean
1306470|NCT02752633|Primary|Urinary 2,8-dihydroxyadenine Excretion||0, 14 and 28 days||||mg/24-h||Full Range|Median
1306471|NCT02752490|Secondary|Number of Participants With Clinical Chorioamnionitis||during labor||||Participants|||Count of Participants
1306438|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I’ve been frustrated because I can’t find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme|||Score on a scale||Standard Deviation|Mean
1306439|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I’ve been frustrated because I can’t find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessm|||Score on a scale||Standard Deviation|Mean
1306440|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I’ve been frustrated because I can’t find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a Scale||Standard Deviation|Mean
1306441|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I’ve been frustrated because I can’t find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a scale||Standard Deviation|Mean
1306442|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I’ve been frustrated because I can’t find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306472|NCT02752490|Secondary|Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen|"Intrauterine resuscitation includes administration of terbutaline, amnioinfusion, cessation of oxytocin, and intravenous (IV) fluid boluses. In this measure, the number of participants who received any of these 5 procedures will be reported in aggregate as the number of participants who received intrauterine resuscitation other than administration of maternal oxygen."|during labor||||Participants|||Count of Participants
1306473|NCT02752490|Secondary|Total Duration of Maternal Oxygen Use||during labor|For this outcome measure, the number of participants analyzed is not equal to the number of participants who started or completed the study because not all participants received oxygen. All who received oxygen were analyzed for this measure.|||minutes||Inter-Quartile Range|Median
1306443|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306444|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306445|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona Scale||Standard Deviation|Mean
1306446|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306447|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306448|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306474|NCT02752490|Secondary|Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU)||from time of birth to discharge from hospital (an average of 2-4 days)||||Participants|||Count of Participants
1306530|NCT02750501|Secondary|Changes in Plasma Concentration Total DHA+EPA|Changes in plasma concentration total DHA+EPA from baseline (Day 0 to Day 90).|RELiZORB Treatment Period (Day 0-Day 90): 90 days|All subjects who entered the RELiZORB Treatment period, received at least one treatment with the study device and completed the study.|||percentage of total plasma concentration||95% Confidence Interval|Least Squares Mean
1306449|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don’t touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306450|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don’t touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona scale||Standard Deviation|Mean
1306451|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don’t touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306452|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don’t touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306453|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don’t touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306475|NCT02752490|Secondary|Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes|The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.|5 minutes after birth||||Participants|||Count of Participants
1306476|NCT02752490|Secondary|Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status||at time of birth||||Participants|||Count of Participants
1306603|NCT02746809|Secondary|Percentage of Participants With Major Vascular Complication|Percentage of participants with Major vascular complication - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
1306454|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don’t touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306455|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can’t finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306456|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can’t finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306457|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can’t finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306458|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can’t finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306459|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can’t finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona scale||Standard Deviation|Mean
1306477|NCT02752490|Secondary|Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth||at time of birth|For this outcome measure, the number of participants analyzed is not equal to the number of participants who started or completed the study because each participant's provider determines whether umbilical artery pH is analyzed, and thus, umbilical artery pH is not collected for every participant in the study.|||Participants|||Count of Participants
1306478|NCT02752490|Primary|Number of Participants Who Delivered by Cesarean||at time of birth||||Participants|||Count of Participants
1306604|NCT02746809|Secondary|Percentage of Participants With Life Threatening or Disabling Bleeding|Percentage of participants with life threatening or disabling bleeding - see VARC-2 definitions for classification details|30 days post-implantation||||percentage of participants||95% Confidence Interval|Number
1306460|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can’t finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
1306461|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 24|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a Scale||Standard Deviation|Mean
1306462|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 20|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306463|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 16|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona Scale||Standard Deviation|Mean
1306464|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona Scale||Standard Deviation|Mean
1306465|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 8|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306466|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
1306467|NCT02752802|Secondary|Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.|To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.|All data will be collected on the day of the procedure, over an average of 12 hours.|Only treatments subjects were analyzed for this endpoint.|||Number of Events|||Number
1309494|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm||Week 144|||||||
1306479|NCT02751450|Secondary|Change From Baseline in Tactile Threshold on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
1306480|NCT02751450|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
1306481|NCT02751450|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a Scale||Standard Deviation|Mean
1306482|NCT02751450|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
1306483|NCT02751320|Secondary|Enamel Fluoride Uptake (EFU) of All Study Formulation Variables|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.|At Week 4|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[2], Test product3-[3], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1].|||μg/cm^2||Standard Deviation|Mean
1306484|NCT02751320|Secondary|Enamel Fluoride Uptake (EFU) of All Study Formulation Variables|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.|At Week 2|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[1], Test product3-[2], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1].|||μg/cm^2||Standard Deviation|Mean
1306485|NCT02751320|Secondary|TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate|TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).|Baseline upto 4 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2 - [1], Test product 3 - [2], Reference Product 2 - [1] and Reference Product 3 [1].|||[%vol mineral x µm||Standard Deviation|Mean
1306739|NCT02739984|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||mg/dL||Standard Error|Least Squares Mean
1306486|NCT02751320|Secondary|Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks|TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).|Baseline upto 4 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], and Reference Product 2- [1].|||[%vol mineral x µm||Standard Deviation|Mean
1306487|NCT02751320|Secondary|% SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate|SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.|Baseline upto 2 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2- [1], Test product 3- [2], Reference Product 2- [1], and Reference Product 3- [1].|||% SMHR||Standard Deviation|Mean
1306488|NCT02751320|Primary|Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks|SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.|Baseline upto 2 weeks|Intent-to-treat (ITT) population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], Reference Product 1- [1], and Reference Product 2- [1].|||% SMHR||Standard Deviation|Mean
1306489|NCT02750943|Secondary|Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12|Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood ‘Present’ (Trace or Substantial) or ‘absent’ in expectorate was analyzed.|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.|||number of participants|||Number
1306490|NCT02750943|Secondary|Modified Gingival Index (MGI) at Week 4 and Week 12|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.|||score on a scale||Standard Error|Least Squares Mean
1306491|NCT02750943|Secondary|Bleeding Index (BI) at Week 4 and Week 12|BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.|||score on a scale||Standard Error|Least Squares Mean
1306492|NCT02750943|Secondary|Number of Bleeding Sites at Week 4|Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 4|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 4 for respective treatment arm.|||number of bleeding sites||Standard Error|Least Squares Mean
1306516|NCT02750618|Secondary|Change From Baseline in Recumbent Length/Standing Height From Baseline Up to Week 40||Baseline, Weeks 12, 24, 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||cm||Standard Deviation|Mean
1306493|NCT02750943|Primary|Number of Bleeding Sites at Week 12|Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 12 for respective treatment arm.|||number of bleeding sites||Standard Error|Least Squares Mean
1306494|NCT02750930|Primary|Number of Participant With Positive Results of Anti-albiglutide Antibody Production Over Time|Anti-albiglutide antibodies were planned to be assessed using a validated enzyme-linked immunosorbent assay, which utilized a tiered testing approach. It was to be collected at specified timepoints at Week 0, Week 4, Week 10, Week 26 and Week 34 (follow-up). Confirmed positive samples were to be titrated to obtain the titer of anti-albiglutide antibodies. The number of participants with positive results of anti-albiglutide antibody production was to be reported. However, due to early termination only limited number of key safety data was analyzed. This study 204682 was planned as an extension of the main study, 200952 and was supposed to end well after the main study. However, the 204682 extension study was terminated prior to completion of the main study 200952, which is a double-blind study. To preserve the integrity of the main study 200952, results of anti-albiglutide antibody were not completed after the termination.|Up to Week 34|Safety population.||||||
1306495|NCT02750930|Primary|Number of Participants With Clinically Significant Findings for 12-lead ECG|A single 12-lead ECG was performed at the specified timepoints (Weeks 0, 26 and 34) during the study where the participant was instructed to be in semi-recumbent position for 10 to 15 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with clinically significant findings in ECG results has been reported.|Up to Week 34|Safety population.|||Participants|||Number
1306496|NCT02750930|Primary|Number of Participants With Systolic and Diastolic Blood Pressure of PCI|The systolic and diastolic blood pressure, were measured after completion of the ECG sampling at specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). The participants were asked to be either in semi-recumbent or sitting position. During blood withdraws the vitals were performed prior to blood collection. Number of participants with systolic and diastolic blood pressure values of PCI has been reported.|Up to Week 34|Safety population|||Participants|||Number
1306497|NCT02750930|Primary|Number of Participants With Pulse Rate Values of PCI|The pulse rate, was measured after completion of the electrocardiogram (ECG) sampling at specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). The participants were asked to be either in semi-recumbent or sitting position. During blood withdraws the vitals were performed prior to blood collection. Number of participants with pulse rate values of PCI has been reported.|Up to Week 34|Safety population|||Participants|||Number
1306498|NCT02750930|Primary|Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method|Urine samples were collected early morning from the participants at specified timepoints (Weeks 26 to 52). The following urinalysis parameters were measured: specific gravity, power of hydrogen (pH), glucose, protein, blood and ketones by dipstick; microscopic examination (if blood or protein was abnormal). Number of participants with no clinically significant abnormalities in urinalysis dipstick results were reported.|Up to 26 weeks|Safety Population|||Participants|||Number
1306499|NCT02750930|Primary|Number of Participants With Clinical Chemistry Parameters of PCI|The following clinical chemistry parameters were measured: blood urea nitrogen (BUN), creatinine, calcium, bicarbonate, potassium, sodium, chloride, uric acid, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, gamma glutamyl transferase (GGT), total and direct bilirubin, total protein, and albumin at the specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). Number of participants with clinical chemistry paramaters with PCI values has been reported.|Up to Week 34|Safety population|||Participants|||Number
1306500|NCT02750930|Primary|Number of Participants With Hematology Values of Potential Clinical Importance (PCI)|Blood samples were collected from the participants to evaluate the hematology paramaters. The following hematology parameters were measured: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils, at the specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). Number of participants with hematology paramaters with PCI values has been reported.|Up to Week 34|Safety Population.|||Participants|||Number
1306501|NCT02750930|Primary|Number of Participants With Physical Examination Abnormalities|A full physical examination was planned to be done, at a minimum, assessment of the skin (including injection site), head, eyes, ears, nose, throat, thyroid, respiratory system cardiovascular system, abdomen (liver and spleen), lymph nodes, central nervous system and extremities was planned. The evaluation of skin (including injection site), respiratory system, cardiovascular system, abdomen (liver, spleen), and central nervous system was planned; however, it was not performed due to early termination of the study.|Up to Week 34|Safety Population.||||||
1306502|NCT02750930|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect, or is associated with liver injury or impaired liver function. Number of participants who reported any AE or SAE during this extension study or who had ongoing AE or SAE from study 200952 have been presented.|Up to Week 34|Safety Population comprised of all enrolled participants who received at least 1 dose of study medication.|||Participants|||Number
1306503|NCT02750813|Secondary|Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14|The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.|Day 14, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site.|||unitless|Eyes|Standard Deviation|Mean
1306504|NCT02750813|Primary|Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14|"Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Day 14, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of lenses|Eyes||Number
1306505|NCT02750709|Secondary|Apparent Terminal Half-life (t1/2)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
1306506|NCT02750709|Secondary|Terminal Elimination Rate Constant (λz)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1306507|NCT02750709|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Full Range|Median
1306508|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306509|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 72 Hours Post-dose (AUC(0-72))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306510|NCT02750709|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 120 Hours Post-dose (AUC(0-120))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306511|NCT02750709|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306512|NCT02750618|Secondary|Percent Change From Baseline Over Time in Serum ALP||Baseline, Weeks 4, 12, 20, 40|PK/PD Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples.|||U/L||Standard Deviation|Mean
1306513|NCT02750618|Secondary|Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)|The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.|Baseline, Weeks 4, 12, 20, 40|PK/PD Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples.|||U/L||Standard Error|Least Squares Mean
1306514|NCT02750618|Secondary|Change From Baseline in Recumbent Length/Standing Height From Baseline to Weeks 12, 24, and 40 as Assessed by Percentiles||Baseline, Weeks 12, 24, 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||percentiles||Standard Deviation|Mean
1306515|NCT02750618|Secondary|Change From Baseline in Recumbent Length/Standing Height From Baseline to Weeks 12, 24, and 40 as Assessed by Height-for-Age Z-Scores|Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Baseline, Weeks 12, 24, 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||Z score||Standard Deviation|Mean
1309495|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm||Week 96|||||||
1306517|NCT02750618|Secondary|RGI-C Lower Limb Deformity Scores at Week 64|Changes in the severity of lower extremity skeletal abnormalities were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Week 64||2018-10-31|10/2018||||
1306518|NCT02750618|Secondary|RGI-C Lower Limb Deformity Score at Week 40|Changes in the severity of lower extremity skeletal abnormalities were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Week 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
1306519|NCT02750618|Secondary|Change From Baseline in Rickets at Week 64 as Assessed by the RSS|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity. The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Baseline, Week 64||2018-10-31|10/2018||||
1306520|NCT02750618|Secondary|Change From Baseline in Rickets at Week 40 as Assessed by the RSS Total Score|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Baseline, Week 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
1306521|NCT02750618|Secondary|RGI-C Global Score at Week 64|Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Week 64||2018-10-31|10/2018||||
1306522|NCT02750618|Secondary|Radiographic Global Impression of Change (RGI-C) Global Score at Week 40|Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The Analysis of Covariance (ANCOVA) model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Week 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
1306523|NCT02750618|Primary|Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. A serious AE was defined as an AE that at any dose, in the view of either the Investigator or Sponsor, results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability, a congenital anomaly/birth defect, or other important medical events (according to the investigator). An AE was considered a TEAE if it occurred on or after the first dose and was not present prior to the first dose, or it was present prior to the first dose but increased in severity during the study. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).|From the signing of informed consent through the data cutoff date of 20 April 2017 (date of Week 40 assessments for last participant).|Safety Analysis Set: all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1306524|NCT02750618|Primary|Change From Baseline at Week 40 in Serum Phosphorus|The Generalized Estimation Equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.|Baseline, Week 40|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples.|||mg/dL||Standard Error|Least Squares Mean
1306646|NCT02743936|Primary|Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine|Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine|2 minutes after mask placement||||Liters per minute||Inter-Quartile Range|Median
1306531|NCT02750501|Secondary|Unanticipated Adverse Device Effects (UADE)|A UADE is analogous to a serious adverse event (SAE), defined as an AE, occurring at any exposure to the therapeutic agent, that results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant disability or incapacity or a congenital anomaly/birth defect.|RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.|Total ITT population (n=39)|||participants|||Number
1306532|NCT02750501|Primary|Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)|Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index|Day 0 to Day 90|Intent to treat population = 39 subjects who received at least one exposure to RELiZORB. Analysis group is 38 due to one subject discontinuing prior to Visit 3.|||percentage of omega-3 composition||Standard Error|Least Squares Mean
1306533|NCT02750345|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
1306534|NCT02750345|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1306535|NCT02750345|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical analysis for the study.|||hr||Full Range|Median
1306536|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306537|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods must be the reference product), and who had no major protocol deviations thought to impact on the analysis of the pk data were included in the statistical pk analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306538|NCT02750345|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary Pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment includes the reference product), and who had no major protocol deviations thought to impact the analysis of the pk data were included for the statistical pk analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306539|NCT02750345|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least two treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306540|NCT02750332|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
1306541|NCT02750332|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1306542|NCT02750332|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Full Range|Median
1306543|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306544|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306545|NCT02750332|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306546|NCT02750332|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1306547|NCT02750267|Secondary|End of Night Blood Glucose|All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306548|NCT02750267|Secondary|Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL|All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.|68 hours||||events per subject, glucometer <70mg/dL||Standard Deviation|Mean
1306549|NCT02750267|Secondary|Hyperglycemia Area Under the Curve >250 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306550|NCT02750267|Secondary|Hyperglycemia Area Under the Curve >180|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306551|NCT02750267|Secondary|Hypoglycemia Area Under the Curve <70 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306552|NCT02750267|Secondary|Hypoglycemia Area Under the Curve <60|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306553|NCT02750267|Secondary|Mean BG (as Measured by CGM)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||mg/dL||Standard Deviation|Mean
1306554|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306555|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Minimum)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306556|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Maximum)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306557|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306558|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >400 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306559|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >250 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time above 250 mg/dL||Standard Deviation|Mean
1306560|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >180 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time above 180 mg/dL||Standard Deviation|Mean
1306561|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >150 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
1306562|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are <70 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time below 70 mg/dL||Standard Deviation|Mean
1306563|NCT02750267|Primary|Percent of Sensor Glucose Readings Between 70-180 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time in range||Standard Deviation|Mean
1306564|NCT02749370|Secondary|Number of Participants With Adverse Events||From first dose of etanercept to 30 days after last dose, up to 28 weeks.|Participants who received at least 1 dose of etanercept during the study.|||Participants|||Count of Participants
1306565|NCT02749370|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24|The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 12 and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1306566|NCT02749370|Secondary|Patient Assessment of Treatment Satisfaction at Week 24|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306567|NCT02749370|Secondary|Patient Assessment of Treatment Satisfaction at Week 12|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 12|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1312570|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra||||mmHg||Standard Deviation|Mean
1306568|NCT02749370|Secondary|"PSI Pain From Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306569|NCT02749370|Secondary|"PSI Flaking of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306570|NCT02749370|Secondary|"PSI Cracking of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306571|NCT02749370|Secondary|"PSI Stinging of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306572|NCT02749370|Secondary|"PSI Burning of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306573|NCT02749370|Secondary|"PSI Scaling of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306574|NCT02749370|Secondary|"PSI Redness of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306575|NCT02749370|Secondary|"PSI Itch From Psoriasis Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306576|NCT02749370|Secondary|Psoriasis Symptom Inventory (PSI) Total Score at Each Visit|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis.|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306577|NCT02749370|Secondary|Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1306578|NCT02749370|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least I post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306661|NCT02743702|Primary|Change From Baseline Vital Capacity at One Year.|Change from Baseline vital capacity at one year evaluated by spirometer.|At baseline and at 1 year||||percentage of Change of vital capacity||Inter-Quartile Range|Median
1306579|NCT02749370|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306580|NCT02749370|Secondary|Static Physician Global Assessment (sPGA) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1306581|NCT02749370|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306582|NCT02749370|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306583|NCT02749370|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement."|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1306584|NCT02749370|Secondary|Percentage of Participants With a PASI 90 Response at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306585|NCT02749370|Secondary|Percentage of Participants With a PASI 50 Response at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306586|NCT02749370|Secondary|Percentage of Participants With a PASI 75 Response at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
1306587|NCT02749370|Primary|Percentage of Participants With a PASI 75 Response at Week 12|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and week 12|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used for participants with missing data at week 12.|||percentage of participants||95% Confidence Interval|Number
1306588|NCT02748889|Primary|Progression Free Survival (PFS) With Carboplatin, Etoposide and MPDL3280A Compared to Chemotherapy Alone According to RECIST v1.1|Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and bone scans.|From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.||||months||Standard Deviation|Mean
1306662|NCT02743117|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of participants|||Number
1306589|NCT02748213|Secondary|Duration of Response (DOR) According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|"FAS Population. The Number of Participants Analyzed reflects the number of participants with a best overall response of CR or PR who provided evaluable data for the analysis."|||months||Full Range|Median
1306590|NCT02748213|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.|||months||95% Confidence Interval|Median
1306591|NCT02748213|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.|||percentage of participants|||Number
1306592|NCT02748213|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.|||months||95% Confidence Interval|Median
1306593|NCT02748213|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.|||percentage of participants|||Number
1306594|NCT02748213|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|Full Analysis Set (FAS) Population.|||percentage of participants||95% Confidence Interval|Number
1306595|NCT02746809|Secondary|Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace|Total prosthetic regurgitation (none/trace) as measured by transthoracic echocardiogram and assessed by echo core laboratory|30 days and 6 months|Only participants with echo could be analyzed.|||percentage of participants|||Number
1306596|NCT02746809|Secondary|Hemodynamic Performance Metrics- Aortic Valve Area|Aortic valve area as measured by transthoracic echocardiogram and assessed by echo core laboratory|Baseline, 30 Days, and 6 Months|Only participants with echo could be analyzed.|||cm2||Standard Deviation|Mean
1306597|NCT02746809|Secondary|Hemodynamic Performance Metrics - Mean Gradient|Mean gradient (mmHg) as measured by transthoracic echocardiogram and assessed by echo core laboratory|Baseline, 30 days, and 6 months|Only participants with echo could be analyzed.|||mmHg||Standard Deviation|Mean
1306598|NCT02746809|Secondary|Percentage of Resheath and Recapture Success|"Successful resheathing is defined as Evolut R TAV (including frame) was resheathed into the capsule of the delivery cathether to the desired amount intended, as verified by fluoroscopy.~Successful recapture is defined as the entire Evolut R TAV (including frame) is resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip, as verified by fluoroscopy."|Implant procedure|Success could only be analyzed in subjects where the resheath/recapture feature was used.|||percentage of participants|||Number
1306599|NCT02746809|Secondary|Percentage of Subjects With Permanent Pacemaker Implant at 30 Days|Percentage of subjects with new permanent pacemaker implant at 30 days.|30 days|Subjects with pre-existing pacemaker or internal cardiac defibrillator were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1306600|NCT02746809|Secondary|Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure|Percentage of subjects with valve-related dysfunction requiring repeat procedure - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
1306601|NCT02746809|Secondary|Percentage of Participants With Coronary Artery Obstruction|Percentage of participants with coronary artery obstruction - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
1306602|NCT02746809|Secondary|Percentage of Participants With Acute Kidney Injury: Stage 2 or 3|Percentage of participants with Acute Kidney Injury: Stage 2 or 3 - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
1306605|NCT02746809|Secondary|Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days|"VARC II composite safety endpoint includes the following components:~All-cause mortality~All stroke (disabling and non-disabling)~Life-threatening bleeding~Acute kidney injury: stage 2 or 3 (including renal replacement therapy).~Coronary artery obstruction requiring intervention.~Major vascular complication.~Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)"|30 days post-implantation||||percentage of participants||95% Confidence Interval|Number
1306606|NCT02746809|Primary|The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram|The percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory|24 hours to 7 days post implantation||||percentage of participants||95% Confidence Interval|Number
1306607|NCT02746809|Primary|Device Success Rate|"Device Success defined as:~Absence of procedural mortality, AND~Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND~Intended performance of the prosthetic heart valve, defined as the absence of patient prosthesis-mismatch and mean gradient < 20 mmHg (or peak velocity < 3 m/sec), AND~Absence of moderate or severe prosthetic valve regurgitation"|24 hours to 7 days post implantation||||percentage of participants||95% Confidence Interval|Number
1306608|NCT02746809|Primary|Percentage of Participants With Stroke (Disabling)|Percentage of participants with disabling stroke (VARC-II definitions) at 30 days|30 Days||||percentage of participants||95% Confidence Interval|Number
1306609|NCT02746809|Primary|Percentage of Participants With All-cause Mortality|Percentage of participants with all-cause mortality at 30 days|30 Days||||percentage of participants||95% Confidence Interval|Number
1306610|NCT02746679|Secondary|The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306611|NCT02746679|Secondary|The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306612|NCT02746679|Secondary|The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306613|NCT02746679|Secondary|The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306614|NCT02746679|Secondary|The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306615|NCT02746679|Secondary|The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306616|NCT02746679|Secondary|The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306617|NCT02746679|Secondary|The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
1306618|NCT02746679|Secondary|The Zung Self-Rating Depression Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).|Baseline and 8 weeks||||units on a scale(raw scores)||Standard Deviation|Mean
1306619|NCT02746679|Secondary|Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery||3 months||||participants|||Number
1306620|NCT02746679|Secondary|Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation||3 months||||units on a scale||Standard Deviation|Mean
1306621|NCT02746679|Secondary|Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.||3 months||||mm||Standard Deviation|Mean
1306622|NCT02746679|Primary|The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).|Baseline and 8 weeks||||units on a scale(raw scores)||Standard Deviation|Mean
1306623|NCT02746406|Primary|Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.|Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group|Through study completion, an average of 4 days||||participants|||Number
1306624|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score|The proportion of OAC prescription for the range 1-5 of CHA2D2s-VASC scores. CHA2D2S-VASC risk score ranges from 1-5, with higher scores indicating a greater risk of stroke.|5 min||||participants|||Number
1306625|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)|the participant physicians were randomized to prescribe to virtual patients or to imagine that the risk seen in the diagram was that of themselves|5 min||||participants|||Number
1306626|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)|the proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years|5 minutes||||participants|||Number
1306627|NCT02746107|Primary|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams|after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment|after seeing the decision aid (5 min)||||participants|||Number
1306628|NCT02745626|Secondary|Amount of Root Resorption Observed for Maxillary Second Premolar = Length of Root at T0-Length of Root at T2 (in mm)|Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2)|T0-T2: 18 months of treatment||||millimeter (mm)||Standard Deviation|Mean
1306629|NCT02745626|Secondary|Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm)|Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2). Therefore the data values indicate the difference in the root length ( in mm).|T0-T2: 18 months of treatment||||millimeter (mm)||Standard Deviation|Mean
1306630|NCT02745626|Secondary|S.Mutans Count|To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution)|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||CFU/ml||Standard Deviation|Mean
1306631|NCT02745626|Secondary|Total Bacterial Count|To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution).|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||CFU/ml||Standard Deviation|Mean
1306632|NCT02745626|Secondary|Bleeding Index|"An evaluation of the amount of inflammation.~The following scores were used:~0 no bleeding~singular bleeding point~several bleeding points or a thin bleeding line along the marginal gingiva~bleeding in the entire interdental gingival triangle immediately after probing~profuse bleeding during probing, bleeding extending over the marginal gingiva eventually with development of blood drops"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||Bleeding index (BI)||Standard Deviation|Mean
1306633|NCT02745626|Secondary|Gingival Index|"An evaluation of the gingival architecture . The following scores were used :~0 Physiologic gingiva~Mild inflammation (slight color change and little change in texture)~Moderate inflammation (moderate glazing, redness, edema and hypertrophy, bleeding on probing)~Severe inflammation (marked redness and hypertrophy, ulceration. tendency to bleed spontaneously)"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||Gingival Index (GI)||Standard Deviation|Mean
1306634|NCT02745626|Primary|Plaque Index|"A measure of the plaque levels on the desired tooth surface. The following scores were used:~0 no plaque/debris on inspection and probing~thin film of plaque only visible after probing~ribbon-like layer of plaque covering the sulcus & gingival crown areas but not filling interdental space~thick layer of plaque already visible at inspection and filling interdental space"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||Plaque Index (PI)||Standard Deviation|Mean
1306635|NCT02745392|Primary|Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject)|The proportion of subjects with freedom from the subject's pre-specified most bothersome symptom at 2 hours is one of two parts of the co-primary efficacy endpoint. This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success.|2 hours|mITT|||Participants|||Count of Participants
1306636|NCT02745392|Primary|Proportion of Subjects With Pain Freedom|Pain Freedom at 2 hours post study drug administration is one of the co-primary endpoints. Subjects were queried via their eDiary about their level of migraine pain (none, mild, moderate, or severe) at various intervals post-dose. Subjects who answered none at 2 hours post study drug were considered pain free at 2 hours.|2 hours|mITT population includes all subjects who were randomized, received any amount of study drug (applied the patch(es) to treat a qualifying migraine, and had at least 1 post-treatment efficacy assessment|||Participants|||Count of Participants
1306637|NCT02743962|Other Pre-specified|Subjective Reports of Adverse Events|Participant reports of adverse events will be recorded to inform development of the method|0 to 12 weeks||||Number of adverse events|||Number
1306638|NCT02743962|Secondary|Perceived Ease of Therapeutic Wand Use|"This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived ease of using a therapeutic wand. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived ease of therapeutic wand use. Patients mark along the score line to indicate their perceived ease of therapeutic wand use. The number of millimeters from the 0 point was recorded as their score, for example 57mm. This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded."|0 to 12 weeks||||units on a scale||Standard Deviation|Mean
1306639|NCT02743962|Secondary|Change in Perceived Overall Pain|"This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived overall pain. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived overall pain. Patients mark along the score line to indicate their perceived overall pain. The number of millimeters from the 0 point was recorded as their score, for example 57mm. This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded."|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1306640|NCT02743962|Secondary|Change in Perceived Urinary Urgency|"This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived urinary urgency. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived urinary urgency. Patients mark along the score line to indicate their perceived urinary urgency. The number of millimeters from the 0 point was recorded as their score, for example 57mm. This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded."|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1306641|NCT02743962|Secondary|Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale|Single page questionnaire of urinary symptoms, sexual symptoms and perceived bother. This outcome measure has 12 questions, each has between 2 and 4 potential responses which are weighted between 0 and 4 units. The total achievable in this outcome measure is a score of 35 and the least achievable is a score of 0. A higher score describes a worse urinary symptoms, sexual symptoms and a greater burden of the symptoms on the individual. Total scores were collected for analysis at baseline and 12 weeks.|0 to 12 weeks||||units on a scale||Standard Deviation|Mean
1306642|NCT02743962|Secondary|Change in Genitourinary Pain Index|Single page questionnaire of genital pain and rating of perceived bother. This outcome measure has 9 questions, each has between 4 and 10 potential responses which are weighted differently, between 0 and 10 units. The total achievable in this outcome measure is a score of 45 and the least achievable is a score of 0. A higher score describes a higher perceived genital pain level and greater burden of symptoms on the individual. Total scores were collected for analysis.|0 to 12 weeks||||units on a scale||Standard Deviation|Mean
1306643|NCT02743962|Primary|Change in O'Leary-Sant Interstitial Cystitis Problem Index Score|"Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4. The total achievable in this outcome measure is a score of between 0 to 16. A higher score describes greater burden of Interstitial Cystitis symptoms on the individual.~Total scores were collected for analysis."|Baseline to 6 weeks and 6 to 12 weeks||||units on a scale||Standard Deviation|Mean
1306644|NCT02743962|Primary|Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score|Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4 or 5. The total achievable in this outcome measure is a score of between 0 to 19. A higher score describes greater symptoms of Interstitial Cystitis. Total scores were collected for analysis.|Baseline to 6 weeks and 6 to 12 weeks||||units on a scale||Standard Deviation|Mean
1306645|NCT02743936|Secondary|Patient Discomfort (Verbal Numerical Rating Scale)|Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)|After study completion (approximately 2 minutes after study start)||||Scores on verbal numerical rating scale||Inter-Quartile Range|Median
1306740|NCT02739984|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306647|NCT02743780|Secondary|Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. C12 is reported as mass/volume.|Up to Day 8|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
1306648|NCT02743780|Secondary|Part 2: Accumulation Ratio (Racc)|Accumulation Ratio was derived using Cmax on Day 7 versus Cmax on Day 1. Approximately 2 mL of venous blood was collected at each time point.|Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
1306649|NCT02743780|Secondary|Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUCtau is reported as mass*time/volume.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng*h/mL||Standard Deviation|Mean
1306650|NCT02743780|Secondary|Part 2: Time to Reach Maximum Concentration [Tmax (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||hours||Full Range|Median
1306651|NCT02743780|Secondary|Part 2: Maximum Observed Concentration [Cmax (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
1306652|NCT02743780|Secondary|Part 1: Terminal Elimination Half-life [t1/2 (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid t1/2.||||||
1306653|NCT02743780|Secondary|Part 1: Area Under the Concentration-time Curve From 0 to Infinity [AUCinf (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid AUCinf.||||||
1306654|NCT02743780|Secondary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to 120 Hours Post Dose [AUC0-120 (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of the lower limit of quantitation (LLOQ) (0.05 ng/mL), none of the observed individual profiles could generate valid AUC0-120.||||||
1306655|NCT02743780|Secondary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUClast (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUClast is reported as mass*time/volume.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng*h/mL||Standard Deviation|Mean
1306656|NCT02743780|Secondary|Part 1: Time to Reach Maximum Concentration [Tmax (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||hours||Full Range|Median
1306657|NCT02743780|Secondary|Part 1: Maximum Observed Concentration [Cmax (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|This analysis population includes all subjects who received IP, had at least 1 plasma sample following exposure to non-placebo IP and had no known specimen collection or analytical deviations which would affect the integrity of the data (Pharmacokinetic (PK) Analysis Set). Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
1306658|NCT02743780|Secondary|Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, up to Day 9|Full Analysis Set|||mmHg||Standard Deviation|Mean
1306659|NCT02743780|Primary|Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, Day 8|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
1306660|NCT02743780|Primary|Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, Day 8|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
1312571|NCT02502487|Secondary|Mean Arterial Pressure Before Gel Administration||before gel administration||||mmHg||Standard Deviation|Mean
1306663|NCT02743117|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and Day 181|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
1306664|NCT02743117|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
1306665|NCT02743117|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of participants|||Number
1306666|NCT02743117|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.|||Percentage of participants|||Number
1306667|NCT02742987|Secondary|Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units||4 weeks|||||||
1306668|NCT02742987|Secondary|Platelet Reactivity|Platelet reactivity assessed with the VerifyNow P2Y12 Assay|4 weeks|||||||
1306669|NCT02742987|Secondary|Endothelium-independent Dilation of the Brachial Artery|Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin|4 weeks|||||||
1306670|NCT02742987|Secondary|Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%||4 weeks|||||||
1306671|NCT02742987|Primary|Flow-mediated Dilation of the Brachial Artery|Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion|4 weeks||||FMD (%)||Standard Deviation|Mean
1306672|NCT02742818|Secondary|Duration of Surgery ( in Minutes)|The investigators will observe the duration of surgery (in minutes) in the two groups studied.|Across duration of surgery ( in minutes)|Models of generalized estimation equations will be used to evaluate the evolution of body temperature across duration of surgery (in minutes)|||minutes||Inter-Quartile Range|Median
1306673|NCT02742818|Secondary|Type of Surgery ( LEA and EVAR )|The investigators will observe the type of surgery distribution profile in the two groups studied.|At time of surgery ( in minutes)||||Participants|||Count of Participants
1306674|NCT02742818|Secondary|Gender|The investigators will observe gender distribution in the two groups studied.|At time of surgery ( in minutes)||||Participants|||Count of Participants
1306675|NCT02742818|Secondary|Age ( in Years)|The investigators will observe the profile of the patients and the mean of age in two groups.|At time of surgery ( in minutes)||||years||Inter-Quartile Range|Median
1306676|NCT02742818|Primary|Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.|After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.|Across duration of surgery (up to 210 minutes)|In the Underbody blanket group 2 patients were excluded from analysis. One of the patients due to anaphylactic reaction and the other framed exclusion criteria (Surgery time lesser than 45 minutes)|||Celsius degrees||Full Range|Median
1306677|NCT02741713|Secondary|Time From Block Placement to Onset of Axillary Pain|Time self-reported by patients in the Interscalene Plus PECS Blocks group during data collection phone call at 24 hours post-block.|Assessed 24hrs post-block in hours|This Outcome Measure was assessed only in the Interscalene Plus PECS Blocks group|||Hours||95% Confidence Interval|Mean
1306678|NCT02741713|Secondary|Total Opioid Usage|Recorded in oxycodone equivalents in the first 24 hours post-discharge from the PACU.|Assessed 24hrs post-block in mg||||mg||95% Confidence Interval|Mean
1306679|NCT02741713|Secondary|Percentage of Participants With Episodes of Nausea or Vomiting|Any episodes during the first 24 hours will be recorded as a yes.|Assessed 24hrs post-block (yes/no)||||percentage of participants|||Number
1306680|NCT02741713|Secondary|Numerical Rating Scale Pain Scores (0-10) at Rest|Subjects were asked about their overall shoulder pain during the followup phone call at 24hrs post-block. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.|Assessed 24hrs post-block on a scale from 0-10.||||units on a scale||Inter-Quartile Range|Median
1306682|NCT02741687|Secondary|Number of Participants Experiencing Complications|The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented.|Up to 40 days (average time of discharge from the hospital plus 30 days)||||Participants|||Count of Participants
1306683|NCT02741687|Secondary|Number of Participants With Emergency Room Visits After Discharge|Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known.|Up to 40 days (average time of discharge from the hospital plus 30 days)||||Participants|||Count of Participants
1306684|NCT02741687|Secondary|Number of Participants With Hospital Readmissions After Discharge|Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known.|Up to 40 days (average time of discharge from the hospital plus 30 days)||||Participants|||Count of Participants
1306685|NCT02741687|Secondary|Number of Days in the ICU|The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required.|Up to time of discharge from hospital, an average of 10 days|This analysis includes participants who were transferred to the ICU following surgery.|||days||Inter-Quartile Range|Median
1306686|NCT02741687|Secondary|Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization|The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery.|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
1306687|NCT02741687|Secondary|Number of Participants With Hypoglycemic Events|Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL)|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
1306688|NCT02741687|Secondary|Length of Hospital Stay|Total length of hospital stay|Up to time of discharge from hospital, an average of 10 days||||days||Inter-Quartile Range|Median
1306689|NCT02741687|Secondary|Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin|Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo|Up to time of discharge from hospital, an average of 10 days|The population for this analysis is limited to participants who received insulin during their hospital stay following surgery.|||international units of insulin|||Number
1306690|NCT02741687|Secondary|Number of Patients Requiring Supplemental, Subcutaneous Insulin|Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
1306691|NCT02741687|Primary|Number of Participants Experiencing Stress Hyperglycemia|The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL.|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
1306692|NCT02741245|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306693|NCT02741245|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306694|NCT02741245|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN|Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306695|NCT02741245|Primary|Percentage of Participants With Potential Hy's Law Condition|Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkalinephosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306696|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306697|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 10x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306698|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥10 Times Upper Normal Limit (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306699|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥5 Times Upper Normal Limit (ULN)|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 5x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306700|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥5 Times Upper Normal Limit (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306701|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306702|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L..|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306703|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Normal Limit (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306704|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Hepatitis-related AEs|Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306705|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs|Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306706|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Gallbladder-related AEs|Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306707|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs|Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306708|NCT02741245|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event|An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued due to an AE was summarized.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of participants|||Number
1306709|NCT02741245|Primary|Percentage of Participants Who Experience at Least 1 Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
1306710|NCT02741245|Primary|Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C)|Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. Results were reported as a M-estimate.|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug, had baseline or post-baseline data and had baseline data for those analyses that required baseline data.|||Percentage Change||95% Confidence Interval|Mean
1306711|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at TOC|The percentage of participants with per-pathogen microbiological responses at TOC was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown.|Day 28 (28 days after initiating study therapy)|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants||95% Confidence Interval|Number
1306712|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at EOT|The percentage of participants with per-pathogen microbiological responses at EOT was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown.|Up to Day 14|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants||95% Confidence Interval|Number
1306713|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at TOC|"The percentage of participants with microbiological response (eradication, persistence, or indeterminate) at TOC was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response."|Day 28 (28 days after initiating study therapy)|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants|||Number
1306714|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at EOT|"The percentage of participants with microbiological responses (eradication, persistence, or indeterminate) at EOT was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response."|Up to Day 14|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants|||Number
1306715|NCT02739997|Secondary|Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Late Follow-Up (LFU)|"The percentage of participants with clinical responses (cure, failure, or indeterminate) at LFU was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure."|Up to Day 42 (28 days after completing study therapy)|Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at LFU visit within the specified visit window are included.|||Percentage of Participants|||Number
1306716|NCT02739997|Secondary|Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at End Of Therapy (EOT)|"The percentage of participants with clinical responses (cure, failure, or indeterminate) at EOT was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure."|Up to Day 14|Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at EOT visit within the specified visit window are included.|||Percentage of Participants|||Number
1306717|NCT02739997|Primary|Percentage of Participants Discontinuing Study Drug Due to AEs|The percentage of participants withdrawing from study therapy due to an AE was determined.|Up to Day 14|All participants who received ≥1 dose of study therapy are included.|||Percentage of Participants||95% Confidence Interval|Number
1309301|NCT02613871|Secondary|HBsAg Level Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12||Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1306718|NCT02739997|Primary|Percentage of Participants With Adverse Events (AEs)|The percentage of participants with ≥1 AEs was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to Day 42 (up to 28 days after completing study therapy)|All participants who received ≥1 dose of study therapy are included.|||Percentage of Participants||95% Confidence Interval|Number
1306719|NCT02739997|Primary|Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Test of Cure (TOC)|"The percentage of participants with clinical responses (cure, failure, or indeterminate) at TOC was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure."|Day 28 (28 days after initiating study therapy)|Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at the TOC visit within the specified visit window are included.|||Percentage of Participants|||Number
1306720|NCT02739984|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306721|NCT02739984|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306722|NCT02739984|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306723|NCT02739984|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306724|NCT02739984|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306725|NCT02739984|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306726|NCT02739984|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306727|NCT02739984|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306728|NCT02739984|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12||Baseline and Week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
1306729|NCT02739984|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
1306730|NCT02739984|Secondary|Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)||Week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
1306731|NCT02739984|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
1306732|NCT02739984|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306733|NCT02739984|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306734|NCT02739984|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306735|NCT02739984|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306736|NCT02739984|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306737|NCT02739984|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306738|NCT02739984|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||mg/dL||Standard Error|Least Squares Mean
1309302|NCT02613871|Secondary|Plasma HBV DNA Change From Baseline at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108||Baseline; Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108|||||||
1306741|NCT02739984|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
1306742|NCT02739698|Primary|The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)|Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).|The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.||||percentage of complete pathological resp|||Number
1306743|NCT02739594|Secondary|Percent Change From Baseline in CrCl|CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as [Week 44 or 92 CrCl minus Baseline CrCl] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who provided data within the specified timeframe for each analysis (n) is shown in the table."|||percent change||Standard Deviation|Mean
1306744|NCT02739594|Secondary|Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline|Elevation in SCr was defined as an increase greater than (>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (<) 1.4 mg/dL, or an increase >1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.|Baseline and Weeks 44, 92|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1306745|NCT02739594|Secondary|Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)|The percent change in GGT was calculated as [Week 44 or 92 GGT minus Baseline GGT] divided by Baseline GGT, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percent change||Full Range|Median
1306746|NCT02739594|Secondary|Percent Change From Baseline in Alpha (A) 1-Microglobulin|The percent change in A1-microglobulin was calculated as [Week 44 or 92 A1-microglobulin minus Baseline A1-microglobulin] divided by Baseline A1-microglobulin, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percent change||Full Range|Median
1306747|NCT02739594|Secondary|Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)|The percent change in B-NAG was calculated as [Week 44 or 92 B-NAG minus Baseline B-NAG] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percent change||Full Range|Median
1306748|NCT02739594|Secondary|Number of Zoledronate Dose Reductions for Each Participant|The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.|||dose reductions||Standard Deviation|Mean
1306749|NCT02739594|Secondary|Percentage of Participants With Zoledronate Dose Reduction|The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.|||percentage of participants||95% Confidence Interval|Number
1306750|NCT02739594|Secondary|Number of Events of Osteonecrosis of Jaw for Each Participant|The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.|From Baseline to end of study (up to Week 96)|ITT Population.|||events of osteonecrosis of jaw||Standard Deviation|Mean
1306751|NCT02739594|Secondary|Percentage of Participants With Osteonecrosis of Jaw|The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1306752|NCT02739594|Secondary|Number of SREs for Each Participant|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.|From Baseline to end of study (up to Week 96)|ITT Population.|||SREs||Standard Deviation|Mean
1306753|NCT02739594|Secondary|Time to First SRE|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. Time to first SRE was defined as the time from first dose of study drug to the time of SRE during the study. The median time to first SRE was estimated by Kaplan-Meier analysis and expressed in days.|From Baseline to end of study (up to Week 96)|ITT Population.|||days||Full Range|Median
1306754|NCT02739594|Secondary|Percentage of Participants With Skeletal-Related Events (SREs)|SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1306755|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported.|Baseline, Week 92|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1306756|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.|Baseline, Week 44|Intent-to-Treat (ITT) Population.|||percentage of participants||95% Confidence Interval|Number
1306757|NCT02739321|Secondary|Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary|"Within subjects comparison of average difficulty for child to go to bed, measured on a scale of 1-7 in which 1 is Extremely Difficult and 7 is Exceptionally Easy, in the mattress technology on and off conditions."|Average daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
1306758|NCT02739321|Secondary|Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary|"Comparison of ease of mattress technology use, measured on a scale of 1-7 in which 1 is Extremely Difficult and 7 is Exceptionally Easy in mattress technology on condition to median score of 4 (average ease of use of mattress technology)."|Average of daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
1306759|NCT02739321|Secondary|Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary|"Comparison of average tolerance of the actigraph watch, measured on a scale of 1-7 in which 1 is Extremely Poor and 7 is Exceptional, across treatment conditions compared to median score of 4 (average toleration of actigraph watch)."|Average of daily measure, across up to 4 Weeks||||units on a scale||Standard Error|Mean
1306760|NCT02739321|Secondary|Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary|"Comparison of average tolerance of mattress technology, measured on a scale of 1-7 in which 1 is Extremely Poor and 7 is Exceptional, in the on condition compared to the median score of 4 (average toleration of mattress technology)."|Average of daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
1306761|NCT02739321|Secondary|Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary|"Within subjects comparison of average challenging behavior/task compliance, measured on a scale of 1-7 in which 1 is Extremely Difficult and 7 is Exceptional in the mattress technology on and off conditions"|Average of daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
1306762|NCT02739321|Secondary|Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire|"Within subjects comparison of the Child and Family Quality of Life 2 (CFQL-2), quality of life average total raw scores across baseline and on and off conditions.~The CFQL-2 is a parent questionnaire that evaluation seven different aspects of child and family quality of life (child, family, caregiver, financial, partner relationship, external support, and coping quality of life). An adapted version was used that decreased the number of total items from 32 to 26 and added an additional item to each scale to specifically evaluate changes of the past two weeks in quality of life. Items use a 5-point Likert scale ranging from (1=strongly disagree/decreased substantially to 3=neutral/same to 5=strongly agree/improved substantially). The total raw score was used to evaluate overall quality of life for child and family (Range=26-130). A lower, overall score indicates a lower quality of life for the child and their family."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
1306763|NCT02739321|Secondary|Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ|"Within subjects comparison of the Short Sensory Profile Questionnaire (SSPQ) average total raw scores across baseline and on and off conditions.~The SSPQ is a parent-completed questionnaire that measures behaviors related to sensory processing abnormalities. Items are based on a 5-point Liker scale ranging from 1=always to 5=never. The total raw score was used to evaluate overall sensory abnormalities (Range=38-190). Lower scores indicate a higher probability of sensory processing abnormalities."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
1306764|NCT02739321|Secondary|Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)|"Within subjects comparison of the Children's Sleep Habits Questionnaire CSHQ average total raw scores across baseline and on and off conditions.~The CSHQ is a parent-completed questionnaire that measures a variety of sleep-related problems using a 3-point Likert-scale (1=rarely/0 to 1 times per week, 2= sometimes/2-4 times per week, 3=usually/5-7 times per week). Ordinarily, parents rate these behaviors for the pas week but for the present study they were instructed to rate for the past two weeks to correspond to the mattress on and off conditions. The total raw scores were use to evaluate overall sleep difficulties (Range = 45-135, in which a higher score is indicative of more sleep problems)."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
1306765|NCT02739321|Secondary|Caregiver-Rated Problems With Sleep Habits as Measured by the FISH|"Within subjects comparison of the Family Inventory of Sleep Hygiene (FISH) average total raw scores across baseline, and on and off conditions.~The FISH is a parent-completed questionnaire that assesses sleep hygiene-related behaviors in children using a 5-point Likert scale (1=Never, 2=occasionally, 3=Sometimes, 4=Usually, 5=Always). Typically parents rate these behaviors with reference to the past month, but for the present study they were asked to rate for only the previous two weeks to correspond to each mattress condition. The total raw score was used to asses sleep hygiene (Range = 12-60, in which higher scores are indicative of better sleep hygiene-related behaviors)."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
1306895|NCT02731131|Secondary|Number of Participants With ALT Normalization at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.|Week 48|ITT Population.|||participants|||Number
1312572|NCT02502487|Secondary|Heart Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope||||Beats per minute||Standard Deviation|Mean
1306766|NCT02739321|Secondary|Caregiver-Rated Communication Problems as Measured by the CCC-2|"Within subjects comparison of the average Children's Communication Checklist (CCC-2) General Communication Composite standard scores across baseline, and on and off conditions.~CCC-2 is a parent questionnaire that assesses children's communication skills across 10 domains using a 4-point Likert type scale (0=less than once a week/never to 3=several times a day/always). The general communication composite standard score based on age norms was used to asses overall communication competency (M=100, SD=15). Lower general communication composite scores indicate a higher likelihood of significant communication problems."|Baseline, 2 weeks, 4 weeks||||Standard Score||Standard Error|Mean
1306767|NCT02739321|Secondary|Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)|"Within subjects comparison of the parent completed Aberrant Behavior Checklist (ABC) total raw score in the baseline, and on and off conditions.~The ABC measures the level of challenging behavior of individuals in and across 5 subdomains (Irritability, lethargy, stereotypy, hyperactivity, inappropriate speech) using a Likert-type scale of 0-3 in which 0 is not at all a problem and 3 is the problem is severe in degree. The sum raw scores of these subdomains make up the total ABC raw score (range = 0-174) in which a higher score indicates more severe challenging behaviors."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
1306768|NCT02739321|Secondary|Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)|"Within subjects comparison of average Social Responsiveness Scale -2 (SRS-2) T-scores in baseline, and on and off conditions.~SRS-2 T-score ranges from 30-90 (M = 50, SD = 10). Higher T-scores indicate a greater extent of social communication deficits."|Baseline, 2 weeks, 4 weeks||||T-score||Standard Error|Mean
1306769|NCT02739321|Secondary|Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.|Within subjects comparison of time spent sleeping (sleep efficiency as percentage) recorded by actigraphy in both the one and off conditions.|Average of daily measure, across up to 2 weeks||||percentage of time||Standard Error|Mean
1306770|NCT02739321|Secondary|Total Time Awake During Night Recorded by Actigraphy Watch|Within subjects comparison of total time awake during night (minutes) recorded by actigraphy watch in both on and off conditions|Average of daily measure, across up to 2 weeks||||Minutes||Standard Error|Mean
1306771|NCT02739321|Secondary|Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch|Within subjects comparison of sleep latency (minutes) recorded by actigraphy watch in the on and off conditions|Average of daily measure, across up to 2 weeks||||Minutes||Standard Error|Mean
1306772|NCT02739321|Secondary|Total Time Asleep Recorded by Actigraphy Watch|Within subjects comparison of the average total sleep time (hours) in the on and off conditions as recorded by actigraphy watch|Average of daily measure, across up to 2 weeks||||Hours||Standard Error|Mean
1306773|NCT02739321|Secondary|Parent Reported Quality of Sleep Across Treatment Conditions|"Within subjects comparison of the average daily, parent reported sleep quality across on and off conditions using a Likert-type scale of 1-7 in which 1 is extremely poor and 7 is exceptional"|Average daily score, across up to 2 weeks||||units on a scale||95% Confidence Interval|Mean
1306774|NCT02739321|Primary|Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology|Compare percentage of drop-out, in this cohort, due to issues with the mattress technology (e.g. ease of use, inability to fall asleep) to a population expected drop-out rate of 30% using a one-sample proportion test.|up to 6 weeks||||Participants|||Count of Participants
1306775|NCT02738853|Secondary|Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace|Total prosthetic regurgitation by transthoracic echocardiogram|30 days and 6 months|Only subjects with TTE could be analyzed.|||percentage of participants|||Number
1306776|NCT02738853|Secondary|Hemodynamic Performance - Mean Gradient|Mean gradient (mmHg) by transthoracic echocardiogram|baseline, 30 days, and 6 months|Only subjects with TTE could be analyzed.|||mmHg||Standard Deviation|Mean
1306777|NCT02738853|Secondary|Hemodynamic Performance - Aortic Valve Area|Aortic Valve Area (cm2) by transthoracic echocardiogram|baseline, 30 days, and 6 months|Only subjects with TTE could be analyzed.|||cm2||Standard Deviation|Mean
1306778|NCT02738853|Secondary|Device Success Rate (VARC II)||24 hours to 7 days||||percentage of participants||95% Confidence Interval|Number
1306779|NCT02738853|Secondary|Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure|Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition|30 days||||percentage of participants||95% Confidence Interval|Number
1306780|NCT02738853|Secondary|Percentage of Patient With Acute Kidney Injury- Stage 2 or 3|Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions|30 days||||percentage of participants||95% Confidence Interval|Number
1306781|NCT02738853|Secondary|Percentage of Participants With Coronary Artery Obstruction|Percentage of participants with coronary artery obstruction - VARC-II definitions|30 days||||percentage of participants||95% Confidence Interval|Number
1306782|NCT02738853|Secondary|Percentage of Participants With Major Vascular Complication|Percentage of participants with major vascular complication - VARC-II definition|30 days||||percentage of participants||95% Confidence Interval|Number
1306783|NCT02738853|Secondary|Percentage of Participants With Life Threatening or Disabling Bleeding|Percentage of participants with life threatening or disabling bleeding - VARC-II definitions|30 days||||percentage of participants||95% Confidence Interval|Number
1306784|NCT02738853|Secondary|Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:|"All-cause mortality~>~All stroke (disabling and non-disabling)~>~Life-threatening bleeding~>~Acute kidney injury: stage 2 or 3 (including renal replacement therapy)~>~Coronary artery obstruction requiring intervention~>~Major vascular complication~>~Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)"|30 days||||percentage of participants||95% Confidence Interval|Number
1306785|NCT02738853|Primary|The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram||30 days|Only subjects with transthoracic echo (TTE) could be analyzed.|||percentage of participants||95% Confidence Interval|Number
1306786|NCT02738853|Primary|Stroke (Disabling) Rate||30 days||||percentage of participants||95% Confidence Interval|Number
1306787|NCT02738853|Primary|All-cause Mortality Rate||30 days||||percentage of participants||95% Confidence Interval|Number
1306788|NCT02738333|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1306789|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306790|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 10||Baseline; Week 10|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306791|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306792|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306793|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 5||Baseline; Week 5|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306794|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306795|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 3||Baseline; Week 3|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306796|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306797|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306798|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306799|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 10||Week 10|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306800|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306801|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306802|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 5||Week 5|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306803|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306804|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 3||Week 3|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306805|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1306806|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306807|NCT02738333|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306808|NCT02738333|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306809|NCT02738333|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1306810|NCT02738333|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1306811|NCT02738255|Secondary|Snoring Index in Simple Snorers|Snoring index is the number of breaths with snoring per hour of sleep. This was measured in both nights (night with Varnum mouthpiece and night without Varnum mouthpiece) only in simple snorers with AHI<10. The median of snoring index was compared between night with Varnum mouthpiece and night without Varnum mouthpiece.|Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece|This outcome was only calculated for simple snorers with AHI<10 events/hour.|||Snore/hour||Inter-Quartile Range|Median
1306812|NCT02738255|Secondary|Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep|The median peak flow during sleep was measured and compared on both nights (night with Varnum mouthpiece and night without Varnum mouthpiece). The median peak flow is a surrogate measure of upper airway collapsibility.|Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece||||L/s||Inter-Quartile Range|Median
1306813|NCT02738255|Primary|Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)|The number of respiratory events (apneas and hypopneas) per hour of sleep. This was measured on two nights in random order (night with Varnum mouthpiece and night without Varnum mouthpiece). The median AHI on the night with Varnum mouthpiece was then compared with median AHI on the night without Varnum mouthpiece.|Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece||||Events/hour||Inter-Quartile Range|Median
1306814|NCT02738138|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|Per protocol, all efficacy analyses were performed using the ITT population including only those participants who had post-treatment data available, excluding reinfection (N = 151). In addition, efficacy analyses were performed overall, combining Treatment Arms A and B.|||percentage of participants||95% Confidence Interval|Number
1306815|NCT02738138|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to 12 weeks|Per protocol, all efficacy analyses were performed using the ITT population; in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.|||percentage of participants||95% Confidence Interval|Number
1306816|NCT02738138|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug.|12 weeks after last dose of study drug|Per protocol, all efficacy analyses were performed using the intention-to-treat (ITT) population (all enrolled participants who received at least 1 dose of study drug); in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.|||percentage of participants||95% Confidence Interval|Number
1306817|NCT02737852|Primary|Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale|Number of subjects with observed local edema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema|2 weeks||||Participants|||Count of Participants
1306818|NCT02737852|Primary|Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale|Number of subjects with observed local erythema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema|2 weeks||||Participants|||Count of Participants
1306819|NCT02737631|Primary|Number of Patients That Showed Edema Based on the 5 Point Scoring Scale||8 weeks||||Participants|||Count of Participants
1306820|NCT02737631|Primary|Number of Patients That Showed Erythema Based on the 5 Point Scoring Scale||8 weeks||||Participants|||Count of Participants
1306821|NCT02737618|Primary|Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale||14 days||||Participants|||Count of Participants
1306822|NCT02737618|Primary|Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale||14 days||||Participants|||Count of Participants
1306823|NCT02737592|Primary|Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale|Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema|2 weeks||||Participants|||Count of Participants
1306824|NCT02737592|Primary|Number of Subjects With Observed Local Erythema Based on 5 Point Scale|Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema|2 weeks||||Participants|||Count of Participants
1306825|NCT02737397|Post-Hoc|Efficacy of Side Effect Prevention Using the Acute Hangover Scale (Hangover Sensitive Subpopulation)|Efficacy of pain medicine + antihistamine in reducing (as compared to placebo) symptoms associated with Veisalgia. The Acute Hangover Scale (AHS) will be used to evaluate side effects on the following morning post alcohol consumption. The scale includes 9 symptom assessments each ranging from 0-10. The total score can range from 0-90. (0= no symptoms, 10 = worst symptom ever).|24 hours|A subset of participants were analyzed post-hoc that were hangover sensitive when compared to placebo.|||score on a scale||Standard Deviation|Mean
1306826|NCT02737397|Primary|Efficacy of Side Effect Prevention Using the Acute Hangover Scale|Efficacy of pain medicine + antihistamine in reducing (as compared to placebo) symptoms associated with Veisalgia. The Acute Hangover Scale (AHS) will be used to evaluate side effects on the following morning post alcohol consumption. The scale includes 9 symptom assessments each ranging from 0-10. The total score can range from 0-90. (0= no symptoms, 10 = worst symptom ever).|24 hours||||score on a scale||Standard Deviation|Mean
1306827|NCT02736721|Primary|Time to Loss of Previous MR|Time to loss of previous MR was defined as the interval between the first day of treatment in the study and the first day of loss of previous MR. MR was assessed using BCR-ABL transcript levels measured by RT-PCR from peripheral blood.|Up to approximately 7 years|Analysis population included all enrolled participants.|||years||95% Confidence Interval|Median
1306828|NCT02736721|Primary|Number of Participants With Molecular Response (MR)|MR was assessed using breakpoint cluster region - Abelson (BCR-ABL) proto-oncogene transcript levels measured by RT-PCR from peripheral blood. Number of participants with BCR-ABL/ABL ratio less than or equal to 10 (%) was reported.|Up to approximately 7 years|Analysis population included all enrolled participants.|||participants|||Number
1306829|NCT02736721|Primary|Time to Loss of Previous CyR|Time to loss of previous CyR was defined as the interval between the first day of treatment in the study and the first day of loss of previous CyR. CyR is based on the prevalence of Ph+ bone marrow cells in metaphase. Major CyR was categorized as either CCyR or PCyR. CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34% of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.|||years||95% Confidence Interval|Median
1306830|NCT02736721|Primary|Number of Participants With Major Cytogenetic Response (CyR)|CyR was based on the prevalence of Philadelphia chromosome-positive (Ph+) bone marrow cells in metaphase determined from reverse transcriptase polymerase chain reaction (RT-PCR). Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34 percent (%) of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.|||participants|||Number
1306831|NCT02736721|Primary|Time to Loss of Previous Hematologic Response|Time to loss of previous hematologic response was defined as the interval between the first day of treatment in the study and the first day of loss of previous hematologic response during elapsed time of study. Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to <10*10^9/L with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.|||months||95% Confidence Interval|Median
1306832|NCT02736721|Primary|Number of Participants With Complete Hematologic Response|Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to less than (<) 10*10^9 per liter (/L) with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.|||participants|||Number
1306833|NCT02736175|Primary|Absence of Ocular Pain|Absence of pain (i.e., score of ‘0’) in the study eye at Day 8|Day 8|ITT LOCF (last observation carried forward)|||percentage of total participants|||Number
1306834|NCT02736175|Primary|Absence of Anterior Chamber Inflammation|Absence of cells (i.e., score of ‘0’) in the anterior chamber of the study eye at Day 14|Day 14|ITT LOCF (last observation carried forward)|||percentage of total participants|||Number
1306835|NCT02735200|Primary|Level of Serum 25 OHD Level Pre-treatment and Post Treatment|Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.|baseline and 5 months||||ng/mL||Standard Deviation|Mean
1306836|NCT02734940|Secondary|Ionotropic Requirement|Total duration of ionotropic requirement (hours)|Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
1306837|NCT02734940|Secondary|Bowel Function|Bowel Function|Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
1306838|NCT02734940|Secondary|Ionotropic Requirement|Total amount ionotropes required|Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
1306839|NCT02734940|Secondary|Delirium Scores|CAM-ICU scores at above time points|24, 48 and 72 hours|The study was terminated because of lack of enrollment. No data was collected.||||||
1306840|NCT02734940|Secondary|ICU Length of Stay||Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
1306841|NCT02734940|Secondary|Extubation|Time from arrival to ICU to extubation|Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)|The study was terminated because of lack of enrollment. No data was collected.||||||
1306842|NCT02734940|Secondary|Patient Satisfaction|Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded)|24 hours, 48 hours, 72 hours, 7 days, 30 days|The study was terminated because of lack of enrollment. No data was collected.||||||
1306843|NCT02734940|Secondary|Postoperative Opioid Consumption|Opioid consumption measured in oral morphine equivalents|24 hours, 48 hours, 72 hours|The study was terminated because of lack of enrollment. No data was collected.||||||
1306844|NCT02734940|Primary|Pain Scores - Numerical Rating Scale, 0-10|Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)|24 hours|The study was terminated because of lack of enrollment. No data was collected.||||||
1306845|NCT02734810|Primary|Safety|Number of subjects reporting 1 or more adverse events|1 week||||Participants|||Count of Participants
1306846|NCT02734355|Secondary|Exercise Tolerance|six-minute walk distance in meters|7 days||||m||Standard Deviation|Mean
1306847|NCT02734355|Secondary|Quality of Life|The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome).|7 days||||units on a scale||Standard Deviation|Mean
1306848|NCT02734355|Primary|Pulmonary Circulation Pressure Load|Right ventricular systolic pressure (RVSP, mm Hg).|7 days||||mm Hg||Standard Deviation|Mean
1306849|NCT02734355|Primary|Left Atrial Pressure Load|Mean left atrial pressure (MLAP, mm Hg).|7 days||||mm Hg||Standard Deviation|Mean
1306850|NCT02734355|Primary|Left Atrial Dimensions|Left atrial antero-posterior diameter (LAD, cm)|7 days||||cm||Standard Deviation|Mean
1306851|NCT02734355|Primary|Left Atrial Contractility|Left atrial active emptying fraction (LAAEF, %)|7 days||||percentage of LA maximum volume||Standard Deviation|Mean
1306852|NCT02734355|Primary|Retrograde Flow in Pulmonary Veins|Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)|7 days||||cm||Standard Deviation|Mean
1306853|NCT02734355|Primary|Pulmonary Vein Flow Emptying|S/D ratio of right superior pulmonary vein flow|7 days||||ratio||Standard Deviation|Mean
1306854|NCT02734355|Primary|Isovolumic Relaxation|Left ventricular isovolumic relaxation time (IVRT, ms).|7 days||||ms||Standard Deviation|Mean
1306855|NCT02734355|Primary|Diastolic Function|E/A ratio of transmitral flow|7 days||||ratio||Standard Deviation|Mean
1306856|NCT02734355|Primary|Left Atrial Reservoir Function|Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.|7 days||||cm||Standard Deviation|Mean
1306857|NCT02734355|Primary|Active Emptying of Left Atrium|Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).|7 days||||cm||Standard Deviation|Mean
1306858|NCT02734355|Primary|Passive Emptying of Left Atrium|Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).|7 days||||cm||Standard Deviation|Mean
1306859|NCT02734212|Secondary|Social Self-Efficacy|The Social Self-Efficacy subscale of Sherer’s Self-Efficacy Scale was used to measure participant’s beliefs or expectations about their abilities with regards to social interactions/relationships. A total score is calculated by summing the responses on the items (range= 5-30). Higher score indicate greater social self-efficacy.|Baseline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment|||units on a scale||Standard Deviation|Mean
1306860|NCT02734212|Secondary|General Self-Efficacy|The General Self-Efficacy subscale of Sherer’s Self-Efficacy Scale was used to measure participant’s general beliefs or expectations about their abilities. A total score is calculated by summing the responses on the items (range= 17-85). Higher score indicate greater general self-efficacy.|Baseline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment|||units on a scale||Standard Deviation|Mean
1306861|NCT02734212|Primary|Internalized Stigma of Mental Illness Inventory (Internalized Stigma)|The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.|Basline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment|||units on a scale||Standard Deviation|Mean
1306862|NCT02734056|Primary|Anxiety|The questions will be scored and a composite score will be determined. The scale is the numeric rating score, from 0-10, where 0 represents no anxiety and 10 represents the worst anxiety. Unit of measure is score on a scale.|1 hour||||NRS||Standard Deviation|Mean
1306863|NCT02732899|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36||baseline to week 36||||letters||Full Range|Mean
1306864|NCT02732899|Primary|Change in Central Subfield Thickness on OCT From Baseline to Week 36|the amount of change in intraretinal and subretinal fluid as measured by microns of central subfield thickness (CST) on Heidelberg Optical Coherence Tomography (OCT)|baseline to week 36||||microns||Full Range|Mean
1306865|NCT02732639|Secondary|Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72|Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1306866|NCT02732639|Secondary|Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72|Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1306867|NCT02732639|Secondary|Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels|Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.|At Screening and at Weeks 48 and 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||participants|||Number
1306868|NCT02732639|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72|Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1306869|NCT02732639|Secondary|Percentage of Participants With Negative HDV RNA at Week 48|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1306870|NCT02732639|Secondary|Percentage of Participants With Normal ALT at Week 48|Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1306871|NCT02732639|Primary|Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1306872|NCT02732639|Primary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72|Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1306873|NCT02732561|Primary|Anxiety|Hamilton Anxiety Rating Scale. The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety (Hamilton, 1959; McDowell, Newell & & McDowell, 2006). The scale consists of 14 items designed to assess the severity of a patient’s anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (with a total score range of 0–56). All of these scores are used to compute an overarching score that indicates a person’s anxiety severity (Vaccarino, 2008). A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Higher values represent a worse outcome.|4 weeks|includes only matched pairs|||units on a scale||Full Range|Median
1306874|NCT02732561|Primary|Depressive Symptoms|Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0–50.|4 weeks|Only includes matched pairs|||units on a scale||Full Range|Median
1306875|NCT02732327|Primary|Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)|Favorable clinical response is defined as resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required as assessed by the investigator. Due to study termination and limited enrollment, outcome measures were not analyzed.|Up to Day 14|||||||
1306876|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 24 Months|Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.|24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1306877|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 12 Months|Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.|12 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1306878|NCT02732210|Secondary|Number of Prolia® Injections Received|The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.|24 months|Full analysis set|||prolia injections||Inter-Quartile Range|Median
1306879|NCT02732210|Secondary|Time to Non-persistence|For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).|24 months|Full analysis set with non-persistence at 24 months|||months||Inter-Quartile Range|Median
1306880|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 24 Months|A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).|24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1306881|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 12 Ponths|A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.|12 months|Full Analysis Set (all enrolled participants)|||percentage of participants||95% Confidence Interval|Number
1306882|NCT02731833|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
1306883|NCT02731833|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
1306884|NCT02731833|Secondary|Change From Baseline in Tactile Threshold on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline to Day 3|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
1306896|NCT02731131|Secondary|Number of Participants With ALT Normalization at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.|Week 96|ITT Population.|||participants|||Number
1306928|NCT02727816|Primary|Post-blink Movement - Pair Four|Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
1306885|NCT02731833|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
1306886|NCT02731313|Secondary|Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The weighted kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by IHC 4B5 and SISH. The weighted kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens' population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of specimens with available data for this outcome measure.|||weighted kappa coefficient|Participants|95% Confidence Interval|Number
1306887|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages|The TNM stage system includes information about the size of the primary tumor (T), whether the cancer has spread to nearby lymph nodes (N) and whether the cancer has metastasized to other parts of the body (M). In the T classification TX indicates that the main tumor cannot be measured, T1, T2, T3 and T4 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. In the N classification NX indicates that the cancer in nearby lymph nodes cannot be measured, N0 indicates that there is no cancer in nearby lymph nodes, N1, N2 and N3 refer to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. In the M classification MX indicates that the metastasis cannot be measured, M0 indicates that the cancer has not spread to other parts of the body and M1 indicates that the cancer has spread to other parts of the body.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.|||percentage of participants|||Number
1306888|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed|The Lauren classification is based on examination of histologic specimens under the microscope and divides adenocarcinoma of the stomach into 3 types: 1) Diffuse type: tumor cells are poorly differentiated, behave aggressively and tend to scatter throughout the stomach (rather than form glands). This type metastasizes to other parts of the body much quicker than intestinal type tumors, 2) Intestinal type: tumor cells are well differentiated, grow slowly and tend to form glands, 3) Mixed type: this type is made up of both intestinal and diffuse types.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.|||percentage of participants|||Number
1306889|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location||At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.|||percentage of participants|||Number
1306890|NCT02731313|Primary|Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using the pathologist’s choice of IHC and ISH techniques in local laboratories, and using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by local and centralized laboratories. The kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens’ population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion.|||kappa coefficient|Participants|95% Confidence Interval|Number
1306891|NCT02731300|Secondary|Number of Epileptic Discharge After Treatment by tDCS||Baseline, 4 Weeks||||epileptic discharges/30 mins||Standard Deviation|Mean
1306892|NCT02731300|Primary|Number of Seizure After Treatment by tDCS||Baseline, 4 Weeks||||seizures||Standard Deviation|Mean
1306893|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.|Week 48|ITT Population.|||participants|||Number
1306894|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.|Week 96|ITT Population.|||participants|||Number
1306897|NCT02731131|Secondary|Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.|Week 48|ITT Population.|||participants|||Number
1306898|NCT02731131|Primary|Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.|Week 96|ITT Population.|||participants|||Number
1306899|NCT02730819|Secondary|Investigator Assessment of Global Improvement From Baseline|The investigator compared the extent of melasma at 20 weeks to a full-face photograph obtained in a standardized manner at baseline. It is a dynamic 7-point scale (0=completely clear to 7=worse).|baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.|||Participants|||Count of Participants
1306900|NCT02730819|Secondary|Change in Melasma Quality of Life Scale (MELASQOL)|The Melasma Quality of Life Scale has 10 items, with responses ranging from 0 (no response) to 7 (bothered all the time. The range of possible scores is 0-70, with a higher score indicating a worse melasma-related quality of life.|baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.|||units on a scale||Full Range|Median
1306901|NCT02730819|Primary|Change in Melasma Area and Severity Index (MASI) Score|"Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on % of the total area involved (A), darkness (D), and homogeneity (H).~Scoring for % area involved: 0=none; 1=<10%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness scoring (hyperpigmentation): 0=normal skin; 1=barely visible; 2=mild; 3=moderate; 4=severe. Homogeneity scoring: 0=normal skin color; 1=specks of involvement; 2=small patchy areas of involvement <1.5 cm diameter; 3=patches of involvement >2 cm diameter; 4=uniform skin involvement without any clear areas).~To calculate the MASI score, the sum of the severity grade for darkness (D) and homogeneity (H) is multiplied by the numerical value of the areas (A) involved and by the percentages of the four facial areas (10-30%). Total MASI score: Forehead 0.3 (D+H)A + right malar 0.3 (D+H)A + left malar 0.3 (D+H)A + chin 0.1 (D+H)A. The total score can range from 0 (normal) to 48 (severe)."|Baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.|||units on a scale||Full Range|Median
1306902|NCT02730728|Secondary|Patient-oriented Outcomes|Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers|48 hours||||units on a scale ( QoR score)||Inter-Quartile Range|Median
1306903|NCT02730728|Secondary|Functional Recovery After Surgery|Cumulative ambulation distance in the second postoperative day measured in feet|48 hours|cumulative ambulation distance in second day after surgery|||Feet||Inter-Quartile Range|Median
1306904|NCT02730728|Secondary|Pain Scores at 48 Hours After Surgery|Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale|48 hours||||units on a scale ( Pain score)||Standard Deviation|Mean
1306905|NCT02730728|Primary|Patients With Severe Pain at 48 Hours After Surgery|The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day|48 hours||||percentage of patients with severe pain|||Number
1306906|NCT02730598|Secondary|Change in Stair Climb Time.|Average time of two trials used for each participant.|Baseline and 12-week follow-up||||seconds||Standard Deviation|Mean
1306907|NCT02730598|Secondary|Change in 5-chair Stand Time.|Average time of two trials used for each participant.|Baseline and 12-week follow-up||||seconds||Standard Deviation|Mean
1306908|NCT02730598|Secondary|Change in 20-meter Walk Time.|Average time of two trials used for each participant.|Baseline and 12-week follow-up||||seconds||Standard Deviation|Mean
1306909|NCT02730598|Secondary|Change in Quality of Life (QOL) Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)|The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale was used at baseline and follow-up to assess participant outcomes. The QOL subscale is made up of 4 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.|Baseline and 12-week follow-up||||units on a scale||Standard Deviation|Mean
1306910|NCT02730598|Secondary|Change in Knee Pain Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)|The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale was used at baseline and follow-up to assess participant outcomes. The pain subscale is made up of 9 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.|Baseline and 12-week follow-up||||units on a scale||Standard Deviation|Mean
1306911|NCT02730598|Secondary|Change in Knee Pain Assessed by a Visual Analog Scale (VAS)|Knee pain will be evaluated using a visual analog scale (VAS) of 100 mm from no pain (0 mm) to the worst imaginable pain (100 mm). Participants will be asked to record their pain levels of the past one week.|Baseline and 12-week follow-up||||millimeters (mm)||Standard Error|Least Squares Mean
1306912|NCT02730598|Secondary|Change in Knee Flexor Strength Assessed by Isokinetic Dynamometer|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee flexor torque, using an isokinetic dynamometer.|Baseline and 12-week follow-up||||Newton-meters (Nm)||Standard Deviation|Mean
1306913|NCT02730598|Primary|Change in Knee Extensor Strength Assessed by Isokinetic Dynamometer.|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque, using an isokinetic dynamometer.|Baseline and 12-week follow-up||||Newton-meters (Nm)||Standard Error|Least Squares Mean
1312573|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||Beats per minute||Standard Deviation|Mean
1306914|NCT02730351|Secondary|Weighted Mean 0-60 Min for Percentage Decrease From Pre-exercise FEV1 Following Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.|The exercise challenge testing at the end of 2 week treatment period was performed on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of double-blind treatment. Following exercise challenge testing, post-exercise FEV1 values were assessed serially at 5, 10, 15, 30, 45 and 60 min. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Percentage of FEV1||Standard Error|Least Squares Mean
1306915|NCT02730351|Secondary|Proportion of Participants With a 30 Min Post-challenge FEV1 no More Than 5 Percent Lower Than Pre-exercise FEV1 Following the Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.|The blinded treatment exercise challenge test was performed at the end of 2-weeks of treatment period 1 and treatment period 2 on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of study treatment. The challenge was followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Participants|||Number
1306916|NCT02730351|Secondary|Maximal Percent Decrease in FEV1 Following Exercise Challenge at 23 Hrs Post Evening Dose From Pre-exercise FEV1.|The exercise challenge test is a stepped challenge on a treadmill. It was performed at 23 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 min and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 23 hr post dose.|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Percentage of FEV1||Standard Error|Least Squares Mean
1306917|NCT02730351|Primary|Maximal Percent Decrease in Forced Expiratory Volume in One Second (FEV1) Following Exercise Challenge at 12 Hours (Hrs) Post Evening Dose From Pre-exercise FEV1.|The exercise challenge test is a stepped challenge on a treadmill. It was performed at 12 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 minutes (min) and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 12 hr post dose. ITT Population comprised of all participants randomized to treatment and who received at least one dose of study medication.|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Percentage of FEV1||Standard Error|Least Squares Mean
1306918|NCT02730260|Primary|Smoking Abstinence for 7 Days at Last Contact|By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.|6-12 months|These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.|||participants|||Number
1306919|NCT02727816|Primary|Overall Fit Acceptance - Pair Four|Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.|Baseline and 1 hour||||number of subjects|||Number
1306920|NCT02727816|Primary|Overall Fit Acceptance - Pair Three|Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.|Baseline and 1 hour||||number of subjects|||Number
1306921|NCT02727816|Primary|Overall Fit Acceptance - Pair Two|Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.|Baseline and 1 hour||||number of subjects|||Number
1306922|NCT02727816|Primary|Overall Fit Preference - Pair One|Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.|Baseline and 1 hour||||number of subjects|||Number
1306923|NCT02727816|Primary|Lens Tightness - Pair Four|Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||percent lens tightness||Standard Deviation|Mean
1306924|NCT02727816|Primary|Lens Tightness - Pair Three|Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||percent lens tightness||Standard Deviation|Mean
1306925|NCT02727816|Primary|Lens Tightness - Pair Two|Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||percent lens tightness||Standard Deviation|Mean
1306926|NCT02727816|Primary|Lens Tightness - Pair One|Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||Percent lens tightness||Standard Deviation|Mean
1306927|NCT02727816|Primary|Post-blink Movement - Pair Four|Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
1306929|NCT02727816|Primary|Post-blink Movement - Pair Three|Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
1306930|NCT02727816|Primary|Post-blink Movement - Pair Three|Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
1306931|NCT02727816|Primary|Post-blink Movement - Pair Two|Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
1306932|NCT02727816|Primary|Post-blink Movement - Pair Two|Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
1306933|NCT02727816|Primary|Post-blink Movement - Pair One|Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
1306934|NCT02727816|Primary|Post-blink Movement - Pair One|Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
1306935|NCT02727816|Primary|Centration - Pair Four|Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
1306936|NCT02727816|Primary|Centration - Pair Three|Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
1306937|NCT02727816|Primary|Centration - Pair Two|Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
1306938|NCT02727816|Primary|Centration - Pair One|Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
1306939|NCT02726971|Secondary|Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy|The menstrual pattern is clarified as four types which includes amenorrhea, scant spotting, light period, normal period. The menstrual pattern of every participant was recored and compared with herself (before and 3 months after surgery). The number showed below is patients whose menstrual pattern had improved after surgery and estrogen therapy.|3 months after surgery||||participants|||Number
1306940|NCT02726971|Secondary|the AFS Score at Third-look Hysteroscopy|The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.|2 months after surgery||||units on a scale||Standard Deviation|Mean
1306941|NCT02726971|Primary|the AFS Score at Second-look Hysteroscopy|The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.|1 months after the surgery||||units on a scale||Standard Deviation|Median
1306942|NCT02726178|Secondary|The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization.|The secondary objective was to identify predictive factors of occurrence of CRE in preterm infants after immunization through the analysis of their HRV. Two annotated polysomnographies were performed for all patients with an AURA PSG GRASS ambulatory and wireless system. Each polysomnography had a duration of 2.5 hours: the first was conducted on enrolment (the day before immunization), and the second was conducted 18 to 24 hours after immunization : we compared the mean of the datas of polysomnographies after to those before immunization.|72 h||||msec||Standard Deviation|Mean
1306943|NCT02726178|Primary|The Change in the Number of CRE (Extracted From Printed Monitoring Tracings Compared to Noted Nurses’ Surveillance) Following the First Dose of Pentavalent Vaccine in Preterm Infants Born < 32 Weeks Gestation After Administration of Ibuprofen.|Immunization with the pentavalent vaccine Diphtheria-Tetanus-Acellular pertussis-Inactivated poliomyelitis-Haemophilus influenzae type b (DTPa-IPV-Hib) at two months of age is known to be associated with cardio-respiratory events (CRE), in 11 to 47% of preterm infants.It is considered that the immature brainstem respiratory control of preterms make them more vulnerable to the inflammatory reaction caused by immunization. We hypothesized that post-immunization CRE are correlated with inflammatory reaction. The primary objective was to examine the impact of endogenous PG inhibition on the occurrence of CRE following the first dose of pentavalent vaccine in preterm infants born < 32 weeks gestation. Total CRE was expressed as the average number of events (desaturation + apneas + bradycardia) / 24 hours. Δ Total CRE / patient / 24 hours was defined as the difference between the average number of events / 24 hours observed before vs. after immunization for each patient.|the mean of CRE occured in the 48h after immunization minus the base line CRE : mesured 24h before immunization||||events/patient/24hours||Standard Deviation|Mean
1306944|NCT02726022|Primary|Change From Baseline in SF-36 MCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
1306979|NCT02723201|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The pharmacokinetic (PK) set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1306945|NCT02726022|Primary|Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
1306946|NCT02726022|Primary|Change From Baseline in SF-36 PCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
1306947|NCT02726022|Primary|Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
1306948|NCT02726022|Primary|Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
1306949|NCT02726022|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
1306950|NCT02725788|Primary|Dressing Wear Time|Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.|Dressing wear time was assessed daily and 8 month dressing wear data are presented|All subjects randomized except three subjects who either failed to have a study dressing applied or whom could not have the primary endpoint ascertained.|||Days||Full Range|Median
1306951|NCT02724644|Secondary|Change in the Hexsel Cellulite Severity Scale (CSS) Total Score|Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||units on a scale||Standard Deviation|Mean
1306952|NCT02724644|Secondary|Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale|At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2).|Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
1306953|NCT02724644|Secondary|Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)|At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3)|Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
1307066|NCT02720952|Secondary|Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE)|"SAEs and AEs reported over the study period.~N.B., Data will not be entered in this section as this is described within the Adverse Events section."|7-10 days|||||||
1306954|NCT02724644|Secondary|Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)|On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3).|Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
1306955|NCT02724644|Secondary|PR-PCSS Change From Baseline|The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||units on a scale||Standard Deviation|Mean
1306956|NCT02724644|Secondary|PR-PCSS Responder Analysis: 1-Level of Severity|Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
1306957|NCT02724644|Secondary|PR-PCSS Responder Analysis: 2-Levels of Severity|Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
1306958|NCT02724644|Secondary|CR-PCSS Change From Baseline|The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||units on a scale||Standard Deviation|Mean
1306959|NCT02724644|Secondary|CR-PCSS Responder Analysis: 1-Level of Severity|Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).|Baseline, Day 71|Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
1306960|NCT02724644|Secondary|CR-PCSS Responder Analysis: 2-Levels of Severity|Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).|Baseline, Day 71|Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
1306961|NCT02724644|Secondary|Percentage of Composite Responders of at Least 1-Level Improvement of Severity|Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales.|Baseline, Day 71|Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication|||Participants|||Count of Participants
1306962|NCT02724644|Primary|Percentage of Composite Responders of at Least 2-Level Improvement of Severity|Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.|Baseline, Day 71|Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication|||Participants|||Count of Participants
1307407|NCT02701361|Primary|Client Satisfaction Questionnaire (CSQ) Score|Acceptability was measured with the adapted Client Satisfaction Questionnaire (CSQ), which assesses credibility and satisfaction (range 9 [low, a worse outcome] to 36 [highest, a better outcome]). Target is mean score >10.|1 month post-randomization||||units on a scale||Standard Deviation|Mean
1306963|NCT02724449|Primary|Number of Participants With Change in Incontinence Associated Dermatitis Score|"Patients who were experiencing Incontinence Associated Dermatitis (IAD) from exposure to urine, stool or a combination of both urine & stool received an application of the barrier film every 72 hours. A skin assessment tool designed for IAD was used to document each patient's IAD score over time. The area scored was divided into 6 zones, l & r buttocks, L & right thighs, perianal & gluteal cleft. The % area within each zone with denudement was X by 9, redness was X by 3 and healthy skin X 1. The total score range of the 6 zones was 0-3654 with 3654 being worst case scenario.~Improvement of IAD Score - At baseline (enrollment) the six zones were evaluated for % of denudement, redness, pink and healthy skin assessed. At the end of subject's participation, assessment were completed again to determine final score & change for improvement was measured by reduction in IAD score No improvement of IAD score - No change in score Progression of IAD score - Increase in IAD score"|Baseline and end of treatment (up to 3 weeks)||||participants|||Number
1306964|NCT02724111|Secondary|Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject|The occurrence of any adverse events was recorded in the post-anesthesia care unit (PACU) and a ward during the postoperative 24 hours.|during the postoperative 24 hours||||Participants|||Count of Participants
1306965|NCT02724111|Secondary|Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU).|the time to reach sedation score 5 (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) at PACU|every 10 min for 1 hour at PACU.||||minute||Standard Deviation|Mean
1306966|NCT02724111|Secondary|The Degree of Bleeding|2.The degree of bleeding of each patient scaled by surgeons (Intraoperative scale for assessment of operating condition of surgical field: 0 - No bleeding, 1 - Slight bleeding - no suctioning of blood required, 2 - Slight bleeding - occasional suctioning required but not threatened the operative field, 3 ‑ Slight‑bleeding - frequent suctioning of blood was required that threatens the operative field a few seconds after suctioning, 4 - Moderate bleeding - frequent suctioning of blood was required which threatens the operative field directly after suctioning, 5 - Severe bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).|Continuously observed during the whole period of surgery, up to 3 hours||||Scores on a scale (NRS; 0-5)||Standard Deviation|Mean
1306967|NCT02724111|Secondary|The Number of Body Movements|The number of body movements (including cough or any diaphragm movement) observed during the surgery.|At the occurrence of the event during surgery, up to 3 hours||||number of event||Standard Deviation|Mean
1306968|NCT02724111|Secondary|The Muscle Tone|The muscle tone of each patient at the screw insertion through the pedicle of spine during surgery scaled by surgeons (1: muscle tone is good, suitable for surgery; 2: muscle tone is moderate, but do not affect the operation; 3: muscle tone is hard, making the operation difficult.).|at the screw insertion through the pedicle of spine during surgery||||Scores on a scale (NRS; 1-3)||Standard Deviation|Mean
1306969|NCT02724111|Secondary|Overall Satisfaction of Surgeons for the Surgical Condition|Overall satisfaction of surgeons for the surgical condition will be assessed by the surgeons who perform surgery using numerical rating scale (NRS; 1-10) after surgery (1, worst; 10, best).|After surgery||||Scores on a scale (NRS; 1-10)||Standard Deviation|Mean
1306970|NCT02724111|Secondary|Mean Value of Pressure of Back Muscle Retractor|Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes during the placement of the retractor): measured by the pressure probe placed between the retractor and the back muscle.|Every 15 minutes at the period of the retractor placement during surgery, up to 2 hours﻿||||mmHg||Standard Deviation|Mean
1306971|NCT02724111|Primary|Mean Value of Peak Inspiratory Pressure|This outcome is the mean value of the peak inspiratory pressure measured at each 15 minute during the anesthesia, which can reflect the degree of the tone of respiratory muscles. As muscle tone increases, airway pressure usually increases due to increased tone of abdominal muscle and respiratory muscles including diaphragm. The longer the surgery goes, the higher the airway pressure gets. Also, as neurospinal surgeries are operated in the prone position, the potential for increased airway pressure is high. As airway pressure gets higher, intrathoracic pressure and intraabdominal pressure also become higher. These consequences may bring about similar results with detrimental effects derived from marked increase in intraabdominal pressure in laparoscopic abdominal surgeries|Every 15 minutes during anesthesia, up to 3 hours﻿||||cmH2O||Standard Deviation|Mean
1306972|NCT02723201|Secondary|Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||Baseline up to Day 2|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
1306973|NCT02723201|Secondary|Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||Baseline up to Day 2|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
1306974|NCT02723201|Secondary|Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose||Baseline up to Day 2|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
1306975|NCT02723201|Secondary|Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)||Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
1306976|NCT02723201|Primary|Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||hour||Standard Deviation|Mean
1306977|NCT02723201|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1306978|NCT02723201|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||hour||Full Range|Median
1306980|NCT02723188|Secondary|Self-reported Fear Rankings|"Participants marked how fearful they are of stimuli used in the task on a single 10-point scale (1=not afraid, 10=extremely afraid). Higher scores therefore reflect greater fear and are worse in the context of treatment for anxiety disorders.~Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome)."|During three-day experimental task||||units on a scale||Standard Deviation|Mean
1306981|NCT02723188|Primary|Galvanic Skin Response (GSR)|"GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders.~Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome)."|During three-day experimental task||||micro-Siemens||Standard Deviation|Mean
1306982|NCT02722967|Primary|Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.|"The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by:~Inbound calls (ie, calls from the subject to the integrated call center) by help type;~Outbound calls (ie, calls from the integrated call center to the subject) by help type.~The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls"|From baseline upto week 9|Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS).|||participants|||Number
1306983|NCT02722837|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1306984|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline (Day 1); Week 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1306985|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline (Day 1); Week 8|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1306986|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline (Day 1); Week 4|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1306987|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline (Day 1); Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306988|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline (Day 1); Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1306989|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12||Week 12|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306990|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8||Week 8|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306991|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4||Week 4|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1306992|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2||Week 2|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306993|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1||Week 1|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306994|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306995|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1306996|NCT02722837|Primary|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event||Up to 12 weeks|Safety analysis Set|||percentage of participants|||Number
1306997|NCT02722837|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1306998|NCT02722564|Primary|Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device|The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.|1 day|The number analyzed for ascending BrAC readings and descending BrAC readings|||percent blood alcohol content|BrAC readings|Standard Deviation|Median
1306999|NCT02722278|Other Pre-specified|Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8|Compare the Oral TU-treated subjects and the Topical Axiron®-treated subjects with respect to number of subjects in the cosyntropin stimulation test substudy with a normal maximum post-stimulation (cosyntropin stimulation) cortisol level at Visit 8.|Approximately 4.5 months||||Participants|||Count of Participants
1307000|NCT02722278|Primary|Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7||Day 105|Intent-to-treat study population All subjects randomized to either Oral TU or Axiron|||Participants|||Count of Participants
1307408|NCT02701361|Primary|Percent of Eligible Participants Who Provide Informed Consent and Were Randomized|Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.|randomization|Following consent, two participants were found to be ineligible.|||Participants|||Count of Participants
1307001|NCT02722239|Primary|Adverse Events|Adverse events data for Dapagliflozin + Metformin, modified-release film-coated tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) and for co-administered Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg, (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), XR tablets, 500 mg/2 tablets (Merck Santé S.A.S, France)|AE information will be collected from the time of the first dosing to the last study procedure made in the hospital, approximately 1 month||||adverse event|||Number
1307002|NCT02722239|Primary|Bioequivalence Consideration: 90% Confidence Intervals for the Test:Reference Geometric Least Squares Mean Ratios|The drugs are considered bioequivalent if the 90% confidence intervals for the Test : Reference products geometric least squares mean ratios of AUC, Cmax и Cmax/AUC parameters are in the range of 80% - 125%.|Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.|The Arms/Groups are combined because the main study goal was to compare the bioequivalence of the study drug and the reference drug which were intaken by all volunteers regardless of the group.|||Geometric least squares mean ratio (%)||90% Confidence Interval|Least Squares Mean
1307003|NCT02722239|Primary|Area Under the “Concentration – Time” Curve (AUC0-∞)||Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.||||ug/mL*h||Standard Deviation|Mean
1307004|NCT02722239|Primary|Area Under the “Concentration – Time” Curve (AUC0-t)||Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.||||ug/mL*h||Standard Deviation|Mean
1307005|NCT02722239|Primary|Maximum Concentration (Cmax).||Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.||||ug/ml||Standard Deviation|Mean
1307006|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Safety Follow-Up Visit (32 Weeks)|Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed.|||Participants|||Count of Participants
1307007|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 24|Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed.|||Participants|||Count of Participants
1307008|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 12|Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed.|||Participants|||Count of Participants
1307009|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 4|Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed.|||Participants|||Count of Participants
1307010|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Baseline (Day 1)|Safety Analysis Set|||Participants|||Count of Participants
1307011|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at the Safety Follow-Up Visit|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Safety Follow-Up Visit (32 Weeks)|Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed.|||Participants|||Count of Participants
1307012|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 24|Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed.|||Participants|||Count of Participants
1307013|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 12|Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed.|||Participants|||Count of Participants
1307413|NCT02701296|Secondary|Plantar Flexion in the Tibial Nerve Distribution|Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
1307014|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 4|Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed.|||Participants|||Count of Participants
1307015|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of Anti-drug Antibodies (ADAs) at Baseline|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Baseline (Day 1)|Safety Analysis Set|||Participants|||Count of Participants
1307016|NCT02722044|Secondary|Number of Participants With Treatment-emergent Injection Site Reactions|An injection site reaction is defined as pain, tenderness, erythema/redness, induration/swelling, and other. If an injection site reaction was observed, a physician was to characterize and document the reaction as an adverse event (AE). Treatment-emergent adverse events (TEAEs) are defined as AEs that started or worsened in severity on or after the first dose of study medication, until study completion/withdrawal or within 30 days following the last treatment for early withdrawn participants.|32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
1307017|NCT02722044|Secondary|Number of Participants With Adverse Events Leading to Premature Study Withdrawal|The number of participants who had an adverse event that led to premature study withdrawal was assessed.|32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
1307018|NCT02722044|Secondary|Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings|Clinical significance was assessed by the Investigator.|Baseline; 32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
1307019|NCT02722044|Secondary|Number of Participants With Vital Signs Outside the Expected Range|Vital signs included respiratory rate, body temperature, pulse rate, and systolic and diastolic blood pressure.|32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
1307020|NCT02722044|Secondary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments|Hematology, clinical chemistry, and urinalysis clinical laboratory parameters were assessed. The hematology panel consisted of complete blood count, hemoglobin, hematocrit, mean cell volume, total leukocytes, and platelet counts. The clinical chemistry panel consisted of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, lactate dehydrogenase, creatine kinase, C-reactive protein, cholesterol, triglycerides, total protein, sodium, potassium, chloride, blood urea nitrogen, creatinine, albumin, calcium, phosphate, glucose, glycosylated hemoglobin, uric acid, and bicarbonate. The urinalysis panel consisted of leucocytes, protein, bilirubin, urobilinogen, glucose, ketones, blood pH, nitrite, and specific gravity. Clinical significance was assessed by the Investigator.|Baseline; 32 Weeks|Safety Analysis Set: all participants who received study medication|||Participants|||Count of Participants
1307021|NCT02722044|Secondary|Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2|"Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as no, the assessment was coded as hazard free."|Week 2|Usability Analysis Set|||Participants|||Count of Participants
1307022|NCT02722044|Secondary|Number of Participants With Successful Injections as Assessed by the Observer at Week 2|"Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second click sound) were checked as yes."|Week 2|Usability Analysis Set|||Participants|||Count of Participants
1307023|NCT02722044|Secondary|Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline|"Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as no, the assessment was coded as hazard free."|Baseline (Day 1)|Usability Analysis Set|||Participants|||Count of Participants
1307024|NCT02722044|Secondary|Number of Participants With Successful Injections as Assessed by the Observer at Baseline|"Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second click sound) were checked as yes."|Baseline (Day 1)|Usability Analysis Set|||Participants|||Count of Participants
1307025|NCT02722044|Secondary|Usability of the Auto-injector at Week 2|The usability measure was the participant rating captured in the PRE- and POST- SIAQ modules at Week 2. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.|Week 2|Usability Analysis Set|||Scores on a scale||Standard Deviation|Mean
1307035|NCT02721875|Primary|Maximum Tolerated Dose (MTD) of Volasertib|The MTD was defined as the highest dose with less than 35% risk of the true dose limiting toxicities (DLT) rate being above 0.33 for schedule A, and the highest dose with less than 40% risk of the true DLT rate being above 0.33 for schedule B. The phase I dose-finding was to be guided by a Bayesian 2-parameter logistic regression model (BLRM) with overdose control in each schedule separately.|First treatment cycle, up to 28 days|Treated Set|||Milligram (mg)/ meter square (m2)|||Number
1307414|NCT02701296|Secondary|Opioid Consumption|Amount of opioid used for the first 24 hours post surgery|24 hours post surgery|Mean consumption of Hydromorphone(mg) post-op day 1|||mg||Standard Deviation|Mean
1307026|NCT02722044|Secondary|Usability of the Auto-injector at Baseline|The usability measure was the participant rating captured in the PRE- and POST- SIAQ modules at Baseline. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.|Baseline (Day 1)|Usability Analysis Set|||Scores on a scale||Standard Deviation|Mean
1307027|NCT02722044|Secondary|Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4|"Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as no, the assessment was coded as hazard free."|Week 4|Usability Analysis Set|||Participants|||Count of Participants
1307028|NCT02722044|Secondary|Number of Participants With Successful Injections as Assessed by the Observer at Week 4|"Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second click sound) were checked as yes."|Week 4|Usability Analysis Set|||Participants|||Count of Participants
1307029|NCT02722044|Primary|Usability of the Auto-injector (AI) at Week 4|The primary usability measure was the participant rating captured in the PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules at Week 4. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.|Week 4|Usability Analysis Set: all participants in the Safety Analysis Set who had usability measurements at Week 4 and who did not have any deviations from the protocol deemed significant enough for exclusion from the usability analysis|||Scores on a scale||Standard Deviation|Mean
1307030|NCT02721875|Secondary|Maximum Measured Plasma Concentration of Volasertib (Cmax) (for Combination)|Maximum measured plasma concentration of volasertib (Cmax) (for combination).|PK samples were to be taken at 5 minutes before drug administration (167:55) and 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after first drug administration of Azacitidine|Due to premature discontinuation of the trial no patient is recruited for combination therapy.||||||
1307031|NCT02721875|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity of Volasertib (AUC0-∞) (for Combination)|Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity of volasertib (AUC0-∞) (for combination).|PK samples were to be taken at 5 minutes before drug administration (167:55) and 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after first drug administration of Azacitidine|Due to premature discontinuation of the trial no patient is recruited for combination therapy.||||||
1307032|NCT02721875|Secondary|Maximum Measured Plasma Concentration of Volasertib (Cmax) (for Monotherapy)|Maximum measured plasma concentration of volasertib (Cmax) (for monotherapy).|PK samples were taken at 5 minutes before drug administration and 0:30, 1:00, 2:00, 3:00, 4:00, 24:00, 167:55, 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after drug administration|All evaluable patients were to be included in the Pharmacokinetic (PK) analysis. Patients who were considered as not evaluable were to be listed with their individual plasma concentrations and individual PK parameters; however, they were not to be included in descriptive statistics for plasma concentrations.|||Nanogram(ng)*/milliliter(mL)|||Number
1307033|NCT02721875|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Last Measured Time Point tz of Volasertib (AUC0-tz) (for Monotherapy)|Area under the plasma concentration-time curve over the time interval from zero to the last measured time point tz of volasertib (AUC0-tz) (for monotherapy).|Pharmacokinetic (PK) samples were taken at 5 minutes before drug administration and 0:30, 1:00, 2:00, 3:00, 4:00, 24:00, 167:55, 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after drug administration|All evaluable patients were to be included in the PK analysis. Patients who were considered as not evaluable were to be listed with their individual plasma concentrations and individual PK parameters; however, they were not to be included in descriptive statistics for plasma concentrations.|||Nanogram(ng)*hour(h)/milliliter(mL)|||Number
1307034|NCT02721875|Secondary|Objective Response Defined as Best Overall Response of Complete Remission, Partial Remission or Haematological Improvement According to the International Working Group 2006 Criteria|Objective response defined as best overall response of complete remission, partial remission or haematological improvement according to the International Working Group 2006 criteria. It is based on Complete remission (CR): Bone marrow: <=5% myeloblasts with normal maturation of all cell lines, Peripheral blood: Hemoglobin >=11 Grams Per Decilitre (g/dL), Platelets >=100 x 109/L, Neutrophils >=1.0 x 109/L, Blasts 0%. Peripheral blood responses had to last at least 4 weeks to qualify for CR. Partial remission (PR): All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by >=50% to baseline but still >5%, Cellularity and morphology not relevant. Peripheral blood responses must last at least 4 weeks to qualify for PR. Haematological improvement (HI): HI was evaluated in patients with abnormal pretreatment values based on Erythroid response, Platelet response, Neutrophil response. Peripheral blood responses had to last at least 8 weeks to qualify for HI.|Up to 168 days|Treated Set|||Participants|||Number
1307064|NCT02721277|Secondary|Measurement of Head Circumference for Growth Increase|Growth increase will be measured by head circumference of participants.|6 months|Study was terminated due to insufficient enrollment||||||
1307036|NCT02721875|Primary|Number of Patients With Dose Limiting Toxicities (DLT) in the First Cycle|DLT was defined as any of the following adverse events (AEs) considered to be related to study drug: 1. Common terminology criteria for adverse events (CTCAE) v4.03 ≥Grade 3 drug related non- haematological toxicity, excluding; ≥Grade 3 untreated nausea, vomiting or diarrhea. Any laboratory abnormality - not considered clinically significant by investigator or resolved spontaneously or could have been recovered with appropriate treatment within 7 days. Grade 3 infection which could be recovered with appropriate treatment within 7 days. Azacitidine injection site reaction or complications related to azacitidine injection. 2. Febrile neutropenia as defined by CTCAE which could not recovered with appropriate treatment within 7 days. 3. Inability to deliver full dose of volasertib according to the assigned dose level within Cycle 1 due to drug-related AEs. 4. Haematological DLTs. 5. Any other drug-related AEs that resulted in the delay of starting new treatment cycle for ≥4 weeks.|First treatment cycle, up to 28 days|Treated Set|||Participants|||Number
1307037|NCT02721641|Primary|Number of Participants Withdrawn From Study Because of LVEF Dysfunction|LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline.|From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)|All enrolled participants with available LVEF data were included in the analysis.|||Participants|||Count of Participants
1307038|NCT02721641|Primary|Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)||From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)|All enrolled participants with available LVEF data were included in the analysis.|||Participants|||Count of Participants
1307039|NCT02721641|Primary|On-Study Duration of Trial Treatment||From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)|Analysis was performed on all enrolled participants.|||days||Full Range|Median
1307040|NCT02721277|Other Pre-specified|Numbers of Blood Infection Obtained From a Central Venous Catheter|A review of the subject's medical record will determine the location from which positive blood cultures were obtained.|6 months|Study was terminated due to insufficient enrollment||||||
1307041|NCT02721277|Other Pre-specified|Numbers of Blood Infection Obtained From a Venipuncture|A review of the subject's medical record will determine the location from which positive blood cultures were obtained.|6 months|Study was terminated due to insufficient enrollment||||||
1307042|NCT02721277|Other Pre-specified|Number of Blood Infections|A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.|6 months|Study was terminated due to insufficient enrollment||||||
1307043|NCT02721277|Other Pre-specified|Number of Days With Central Venous Catheter||6 months|Study was terminated due to insufficient enrollment||||||
1307044|NCT02721277|Other Pre-specified|Number of Days on Oxygen Via Nasal Cannula|Length of therapy with nasal cannula|6 months|Study was terminated due to insufficient enrollment||||||
1307045|NCT02721277|Other Pre-specified|Number of Days on Oxygen Via Continuous Positive Airway Pressure|Length of therapy with nasal continuous positive airway pressure|6 months|Study was terminated due to insufficient enrollment||||||
1307046|NCT02721277|Other Pre-specified|Number of Days on Mechanical Ventilation Via Endotracheal Tube|Length of therapy with mechanical ventilation|6 months|Study was terminated due to insufficient enrollment||||||
1307047|NCT02721277|Secondary|Triglyceride|Laboratory value that evaluates liver function and metabolism of fat|6 months|Study was terminated due to insufficient enrollment||||||
1307048|NCT02721277|Secondary|Alkaline Phosphatase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
1307049|NCT02721277|Secondary|Serum Glucose|Laboratory values that evaluates glucose in the blood|6 months|Study was terminated due to insufficient enrollment||||||
1307050|NCT02721277|Secondary|Total Bilirubin|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
1307051|NCT02721277|Secondary|Alanine Aminotransferase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
1307052|NCT02721277|Secondary|Aspartate Aminotransferase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
1307053|NCT02721277|Secondary|Albumin|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
1307054|NCT02721277|Secondary|Total Protein|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
1307055|NCT02721277|Secondary|Carbon Dioxide Total|Laboratory value that determines acid-base balance|6 months|Study was terminated due to insufficient enrollment||||||
1307056|NCT02721277|Secondary|Number of Participants With Adverse Events Related to Treatment|Laboratory values will be used to determine adverse events.|6 months|Study was terminated due to insufficient enrollment||||||
1307057|NCT02721277|Secondary|Number of Subjects Receiving Breast Milk Diet|Enteral administration of breast milk will be noted|6 months|Study was terminated due to insufficient enrollment||||||
1307058|NCT02721277|Secondary|Number of Subjects Receiving Formula Diet|Enteral administration of formula will be noted|6 months|Study was terminated due to insufficient enrollment||||||
1307059|NCT02721277|Secondary|Length of IV Nutritional Therapy||6 months|Study was terminated due to insufficient enrollment||||||
1307060|NCT02721277|Secondary|Number of Concomitant Medications Received||6 months|Study was terminated due to insufficient enrollment||||||
1307061|NCT02721277|Secondary|Number of Subjects Requiring Surgery||6 months|Study was terminated due to insufficient enrollment||||||
1307062|NCT02721277|Secondary|Measurement of Length for Growth Increase|Growth increase will be measured by length of participants.|6 months|Study was terminated due to insufficient enrollment||||||
1307063|NCT02721277|Secondary|Measurement of Weight for Growth Increase|Growth increase will be measured by weight of participants.|6 months|Study was terminated due to insufficient enrollment||||||
1333302|NCT02043379|Secondary|Serum Creatinine|Pre-operative and 48 hour post-operative maximum creatinine recorded.|48 hours||||mg/dL||Standard Deviation|Mean
1307067|NCT02720952|Secondary|Subject Assessment of Taste of the Product|"Palatability of the investigational product as determined by parent/carer responses to the following questions:~Question 1: My child found swallowing easy. Question 2: My child showed a positive reaction after Infacort was given. Question 3: I would be happy to give my child Infacort in the future. Question 4: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication."|1 minute||||Participants|||Count of Participants
1307068|NCT02720952|Secondary|Serum Cortisol Concentration up to 6 Hours|Serum cortisol concentration 240 minutes after intake of study drug as determined by the central laboratory|240 minutes||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1307069|NCT02720952|Primary|Serum Cortisol Concentration up to 240 Minutes|The primary endpoint will be the maximum levels of serum cortisol concentration up to 240 minutes after intake of study drug as determined by the central laboratory.|240 minutes||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1307070|NCT02720510|Secondary|Progression Free Survival||3 years after the last patient is enrolled to the study|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
1307071|NCT02720510|Secondary|Overall Survival||3 years after the last patient is enrolled to the study|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated..||||||
1307072|NCT02720510|Secondary|Duration of Response||From measurable response to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
1307073|NCT02720510|Secondary|Depth of Response by International Myeloma Working Group (IMWG) Criteria|Rate of Very Good Partial Response (VGPR), Complete Response (CR) and Stringent Complete Response (sCR)|Day 22 up to end of study, approximately 3 years|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
1307074|NCT02720510|Secondary|Best Overall Response Rate (ORR) and MRD Negativity After ASCT and Maintenance|ORR (CR + PR) and MRD negativity after ASCT and maintenance|Month 3 up to end of study, approximately 3 years.|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
1307075|NCT02720510|Secondary|Minimal Residual Disease (MRD) Negativity (mCR) After 4 Cycles of Induction by Next Gen Sequencing|MRD negativity by Clonal Sequencing (ClonoSEQTM) assay (Adaptive Biotechnologies)|Month 3|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
1307076|NCT02720510|Primary|Near Complete Response (nCR)/CR Rate of the Combination of Panobinostat With Bortezomib, Lenalidomide and Dexamethasone (P-RVD) vs RVD in Newly Diagnosed Multiple Myeloma Patients||84 days|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
1307077|NCT02720081|Primary|Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6.|Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment|Analysis population consists of randomized participants who received at least 1 dose of study drug.|||Liter||95% Confidence Interval|Least Squares Mean
1307078|NCT02720081|Secondary|Change From Baseline in Respiratory Rate at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, respiratory rate.|||breaths/min||Standard Deviation|Mean
1307079|NCT02720081|Secondary|Change From Baseline in Respiratory Rate at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, respiratory rate.|||breaths/min||Standard Deviation|Mean
1307080|NCT02720081|Secondary|Change From Baseline in Respiratory Rate at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, respiratory rate.|||breaths/min||Standard Deviation|Mean
1307081|NCT02720081|Secondary|Change From Baseline in Heart Rate at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, heart rate.|||beats/min||Standard Deviation|Mean
1307082|NCT02720081|Secondary|Change From Baseline in Heart Rate at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, heart rate.|||beats/min||Standard Deviation|Mean
1307083|NCT02720081|Secondary|Change From Baseline in Heart Rate at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, heart rate.|||beats/min||Standard Deviation|Mean
1307084|NCT02720081|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, diastolic blood pressure.|||mmHg||Standard Deviation|Mean
1307415|NCT02701296|Primary|Pain Intensity|Pain Intensity is self-reported on a 10-point scale (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery|48 hours post surgery||||pain score on a pain scale||Standard Deviation|Mean
1307085|NCT02720081|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, diastolic blood pressure.|||mmHg||Standard Deviation|Mean
1307086|NCT02720081|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, diastolic blood pressure.|||mmHg||Standard Deviation|Mean
1307087|NCT02720081|Secondary|Change From Baseline in Systolic Blood Pressure at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, systolic blood pressure.|||mmHg||Standard Deviation|Mean
1307088|NCT02720081|Secondary|Change From Baseline in Systolic Blood Pressure at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, systolic blood pressure.|||mmHg||Standard Deviation|Mean
1307089|NCT02720081|Secondary|Change From Baseline in Systolic Blood Pressure at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, systolic blood pressure.|||mmHg||Standard Deviation|Mean
1307090|NCT02720081|Secondary|Change From Baseline in Hematocrit (%) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, hematocrit (%).|||Percent||Standard Deviation|Mean
1307091|NCT02720081|Secondary|Change From Baseline in White Blood Cell Count at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, white blood cell count.|||10^9 cells/L||Standard Deviation|Mean
1307092|NCT02720081|Secondary|Change From Baseline in Platelet Count at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, platelet count.|||10^9 cells/L||Standard Deviation|Mean
1307093|NCT02720081|Secondary|Change From Baseline in Neutrophil (%) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, neutrophil (%).|||% of White Blood Cell differential count||Standard Deviation|Mean
1307094|NCT02720081|Secondary|Change From Baseline in Eosinophil (Percent [%]) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, eosinophil (%).|||% of White Blood Cell differential count||Standard Deviation|Mean
1307095|NCT02720081|Secondary|Change From Baseline in Bilirubin at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, bilirubin.|||mg/dL||Standard Deviation|Mean
1307096|NCT02720081|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, AST.|||IU/L||Standard Deviation|Mean
1307097|NCT02720081|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, ALT.|||IU/L||Standard Deviation|Mean
1307098|NCT02720081|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, ALP.|||IU/L||Standard Deviation|Mean
1307099|NCT02720081|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 6 weeks|Analysis population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1307416|NCT02701270|Secondary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood insulin measurements were available.|||min*mmol/L||Standard Deviation|Mean
1307100|NCT02720081|Secondary|Percentage of Participants Who Experienced an Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 8 weeks|Analysis population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1307101|NCT02720081|Secondary|Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6|A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake “all night”; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Participants needed at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing.|Up to 4 weeks|Analysis population consists of randomized participants who received at least 1 dose of study drug and had at least 80% of days with a complete diary during Weeks 3 to 6 (a diary is considered complete if none of the 6 components used to determine asthma worsening are missing).|||Percentage of days||95% Confidence Interval|Least Squares Mean
1307102|NCT02720081|Primary|Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.|Before the first dose of study investigational product (Baseline)|Analysis population consists of randomized participants who received at least 1 dose of study drug.|||Liter||Standard Deviation|Mean
1307103|NCT02718898|Secondary|Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status|"sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.~sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1."|Week 12|All randomized participants who received at least one dose of study drug and either had baseline and at least 1 post-baseline evaluable samples or had no evaluable baseline and all negative post-baseline anti-drug antibody negative samples.|||Participants|||Count of Participants
1307104|NCT02718898|Secondary|Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items|GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.|Baseline, Week 12|All randomized participants with baseline and post baseline observation for GPSS total or individual item scores.|||units on a scale||Standard Error|Least Squares Mean
1307105|NCT02718898|Secondary|Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)|"SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.~Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method."|Baseline, Week 12|"All randomized participants with baseline and post baseline measurement for SF-36 MCS.~mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||Standard Error|Least Squares Mean
1307106|NCT02718898|Secondary|Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)|"SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.~Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method."|Baseline, Week 12|"All randomized participants with baseline and post baseline measurement for SF-36 PCS.~mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation , Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||Standard Error|Least Squares Mean
1307107|NCT02718898|Secondary|Number of Participants With at Least a 2-Point Change in Patient’s Global Assessment of Genital Psoriasis (PatGA-Genital)|Patient’s Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis “today” by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe).|Week 12|All randomized participants with baseline PatGA-Genital score >= 2.|||Participants|||Count of Participants
1307119|NCT02718248|Secondary|Social Functioning|Social Functioning was measured using the Social Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Social Functioning Subscale is scored using a range of 0-100, with a higher score indicating higher social functioning.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307108|NCT02718898|Secondary|Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score|mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.|Baseline, Week 12|All randomized participants with baseline and post baseline observation for mGPASI.|||units on a scale||Standard Error|Least Squares Mean
1307109|NCT02718898|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|"DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment.~Response categories include:~0 = not at all; 1 = a little; 2 = a lot; 3 = very much; “not relevant” responses scored as “0” and total score range of 0 to 30; higher scores indicate poor quality of life.~Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects."|Baseline, Week 12|All randomized participants with baseline and post baseline observation for DLQI.|||units on a scale||Standard Error|Least Squares Mean
1307110|NCT02718898|Secondary|Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)|"GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity.~The GPSIS Sexual Activity Avoidance Subscale includes 2 items:~Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4)"|Week 12|All randomized participants with baseline GPSIS sexual activity avoidance subscale score >= 3.|||Participants|||Count of Participants
1307111|NCT02718898|Secondary|Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2|"The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always.~*The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire)."|Week 12|All randomized participants with baseline GenPs-SFQ Item 2 Score >= 2.|||Participants|||Count of Participants
1307112|NCT02718898|Secondary|Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS)|GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity).|Week 12|All randomized participants with baseline GPSS Itch NRS Score >= 3.|||Participants|||Count of Participants
1307113|NCT02718898|Secondary|Number of Participants Achieving Overall sPGA (0,1)|"The overall sPGA is the physician’s global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.~Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1."|Week 12|All randomized participants.|||Participants|||Count of Participants
1307114|NCT02718898|Primary|Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)|"sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.~sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1."|Week 12|All randomized participants.|||Participants|||Count of Participants
1307115|NCT02718248|Other Pre-specified|Recruitment Rates at 6 Months|Will be used to assess the feasibility of recruitment for a larger, multicentre cluster randomized controlled trial (RCT). To test feasibility in patients the investigators aim to recruit at least half of the men the study team ask to take part in the pilot study. To test feasibility in referring clinicians, the aim is that at least half of men who present with intentional self-harm to the psychiatric emergency service will be approached and complete the The Ottawa Hospital (TOH) form allowing contact details to be passed on to researchers.|Within 6 months of study launch|This group includes all participants referred to the study (N=15).|||percentage of participants enrolled|||Number
1307116|NCT02718248|Secondary|Participant Exit Questionnaire|The investigators will ask participants about the user comprehension, user practicality and the methods of data collection with regards to the CHESS Mobile Health smart phone application. The Participant Exit Questionnaire will also ask that users make comments or suggestions for future use and development of the application. This will test the acceptability of the intervention and the acceptability of using routine data sources as outcome measures.|within 4 months of study completion||||percentage of participants who agreed|||Number
1307117|NCT02718248|Secondary|Perceived Overall Health|Participants were asked to use the EuroQol 5 Dimensions Visual Analytic Scale to assess their overall health on a scale from 0 to 100, with 100 being the best possible health state.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307118|NCT02718248|Secondary|Health-Related Quality of Life|Generic health-related quality of life index. The total scores on this measure range from 11111 to 33333, with lower values indicating higher levels of health-related quality of life.|Baseline and Week 5||||units on a scale||Full Range|Median
1307120|NCT02718248|Secondary|Bodily Pain|Bodily Pain was measured using the Bodily Pain subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Bodily Pain Subscale is scored using a range of 0-100, with a higher score indicating lower levels of bodily pain.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307121|NCT02718248|Secondary|Mental Health Functioning|Mental Health Functioning was measured using the Mental Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Mental Health Functioning Subscale is scored using a range of 0-100, with a higher score indicating better mental health functioning.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307122|NCT02718248|Secondary|General Health|General Health was measured using the General Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The General Health Subscale is scored using a range of 0-100, with a higher score indicating higher levels of general health.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307123|NCT02718248|Secondary|Vitality|Vitality was measured using the Vitality subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Vitality subscale is scored using a range of 0-100, with a higher score indicating a higher degree of vitality.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307124|NCT02718248|Secondary|Emotional Role Limitations|Emotional Role Limitations was measured using the Emotional Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Emotional Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to emotional health difficulties.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307125|NCT02718248|Secondary|Physical Role Limitations|Physical Role Limitations was measured using the Physical Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to physical health difficulties.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1307126|NCT02718248|Secondary|Physical Functioning|Physical Functioning was measured using the Physical Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Functioning Subscale is scored using a range of 0-100, with a higher score indicating better physical functioning.|Baseline and Week 5||||units on a scale||Standard Deviation|Mean
1307127|NCT02718248|Primary|Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6|"Measures change in the severity of depressive symptoms. Total scores on this scale range from 0 to 27, with higher scores indicating more severe depression symptoms. The scores on the Patient Health Questionnaire (PHQ-9) scale should be interpreted as follows:~0-4: Minimal Depression; 5-9: Mild Depression 10-14: Moderate Depression; 15-19: Moderately Severe Depression; 20 and Above: Severe Depression."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|Throughout the course of the study, the following study time points were missed: Week 1 (2 participants), Week 3 (1 participant) and Week 4 (1 participant).|||units on a scale||Standard Deviation|Mean
1307128|NCT02717754|Secondary|Minimum Plasma Concentration (Cmin) of RO0640802|Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng/mL||Standard Deviation|Mean
1307129|NCT02717754|Secondary|Clearance (CL) of Oseltamivir and RO0640802|CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||Liters/hour||Standard Deviation|Mean
1307130|NCT02717754|Secondary|Volume of Distribution (Vd) of Oseltamivir and RO0640802|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||Liter||Standard Deviation|Mean
1307131|NCT02717754|Secondary|Half-Life (t1/2) of Oseltamivir and RO0640802|t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||hour||Standard Deviation|Mean
1307132|NCT02717754|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802|Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||hour||Standard Deviation|Mean
1307133|NCT02717754|Secondary|Cmax of Oseltamivir and RO0640802|Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng/mL||Standard Deviation|Mean
1307134|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng*hour/mL||Standard Deviation|Mean
1307135|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng*hour/mL||Standard Deviation|Mean
1307136|NCT02717754|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State|Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng/mL||Standard Deviation|Mean
1307137|NCT02717754|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State|AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed.|||ng*hour/mL||Standard Deviation|Mean
1307138|NCT02717273|Secondary|Number of Subjects With Mortality|death within 30 days of liver transplant|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
1307139|NCT02717273|Secondary|Number of Subjects With Graft Loss|complete loss of liver function in recipient|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
1307140|NCT02717273|Secondary|Length of Hospital Stay|days hospitalized after liver transplant|within 30 days from surgery|Had liver transplant|||days||Inter-Quartile Range|Median
1307141|NCT02717273|Secondary|Number of Subjects With Nosocomial Infection|diagnosis of any new infection other than an SSI within 30 days from surgery|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
1307142|NCT02717273|Secondary|Number of Subjects With Elevated White Blood Count (WBC)|above 15,000 within 24hours after the end of the liver transplant|24 hours from surgery|Had liver transplant|||Participants|||Count of Participants
1307143|NCT02717273|Secondary|Number of Subjects With Post-operative Fever|fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant|24 hours from surgery|Had liver transplant|||Participants|||Count of Participants
1307144|NCT02717273|Primary|Number of Subjects With Development of Surgical Site Infections|development of surgical site infection, including superficial and deep incisional and organ space surgical site infections|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
1307145|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of GPT|Tmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||days||95% Confidence Interval|Median
1307146|NCT02716779|Secondary|Maximum Concentration (Cmax) of GPT|Cmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||U/L||95% Confidence Interval|Median
1307147|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT)||From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||(Units/liter)*day ([U/L]*d)||95% Confidence Interval|Median
1307148|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of PEG-IFN|Tmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||weeks||95% Confidence Interval|Median
1307149|NCT02716779|Secondary|Maximum Concentration (Cmax) of PEG-IFN|Cmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||ng/ml||95% Confidence Interval|Median
1307150|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of PEG-IFN|Evaluation of PEG-IFN arm after Day 0. Evaluation of ribavirin and placebo arms after Day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||(nanogram/milliliter)*day ([ng/ml]*d)||95% Confidence Interval|Median
1307151|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of Ribavirin|Tmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||weeks||95% Confidence Interval|Median
1307152|NCT02716779|Secondary|Maximum Concentration (Cmax) of Ribavirin|Cmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||mcg/ml||95% Confidence Interval|Median
1307417|NCT02701270|Primary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood glucose measurements were available.|||min*mmol/L||Standard Deviation|Mean
1307153|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Ribavirin|Evaluation of ribavirin arm after Day 0. Evaluation of placebo and PEG-IFN arms after Day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||(microgram/milliliter)*day ([mcg/ml]*d)||95% Confidence Interval|Median
1307154|NCT02716779|Secondary|Percentage of Participants With Treatment Response|HCV-RNA level was measured at each visit by a central laboratory. Treatment response was estimated applying the following definitions of response/non-response: 1) Adequate first phase decline: HCV RNA decline ≥ 0.5 log10 International Units/milliliter (IU/mL) from time 0 to 48 hours of PEG-IFN treatment (PEG-IFN arm: day 0 – day 2; placebo and ribavirin arm: day 42-day 44), 2) Rapid virologic response: HCV RNA < 15 IU/mL (=detection limit) on day 70, 3) Complete early virologic response: HCV RNA < 15 IU/mL on day 126, 4) Partial early virologic response (log decrease): HCV RNA decrease ≥ 2 log10 IU/mL from day 0 to day 126, 5) Partial early virologic response (cut off): HCV RNA <30000 IU/mL on day 126, 6) Non-response: HCV RNA decrease <2 log10 IU/mL from day 0 to day 126, 7) Null-response: HCV RNA decrease <1 log10 IU/mL from day 0 to day 28 and from day 0 to day 70 for PEG-IFN arm and placebo / ribavirin arm, respectively.|Up to Day 126|All evaluable participants of the Intent-to-Treat (ITT) population, who were documented for a total of 126 days of the treatment period.|||percentage of participants|||Number
1307155|NCT02716779|Secondary|Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire|SF-36 is a psychometric scale to quantify health conditions. This psychometric scale has 8 dimensions of the subjective health status and consists of 36 individual items that have a varying number of related item scores (ranging from “yes/no” up to a 6-point scale). At first the raw scores were determined by summation over all items and weighted accordingly. Afterwards the raw scores were transformed to ranges of 0-100 with 100 being the highest level of health and compared to published reference scales. The following eight dimensions of subjective health conditions were considered: physical functioning index, role physical index, pain, general health perception, vitality, social functioning index, role emotional index and mental health index. The SF36 questionnaire had to be answered by the patients at screening before monotherapy, after monotherapy and at the end of the study (=end of combination therapy).|At screening (Days -56 to -1), at end of monotherapy (Week 6) and at end of combination therapy (Week 18)|Intent-to-treat (ITT) population includes all randomized participants who received at least one dose of study drug. Here, 'n' is the number of evaluable participants.|||units on a scale||Standard Deviation|Mean
1307156|NCT02716779|Primary|Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action|To investigate possible action mechanisms, three different models were fitted to viruskinetic data and evaluated using related log-likelihood function values. These models were designed assuming individual effects with respect to infectiousness (model 1), virus production (model 2) or degradation of infected cells rate (model 3). The following viruskinetic parameters were fitted in each model: initial viral load, loss rate of infected cells (delta), effectivity of interferon with respect to a pharmacokinetic-pharmacodynamic model. A lower log likelihood function value indicates a lesser fit for the model.|Up to Day 126|Per Protocol (PP) population: participants with 6 weeks of monotherapy and at least 4 weeks combination therapy as well as three quantitative HCV-RNA measurements (baseline, period 1, period 2), no major protocol violations, no treatment interruption and no dose reduction below 80% of the planned medication within the first 10 therapy weeks.|||log likelihood function value||95% Confidence Interval|Median
1307157|NCT02716714|Other Pre-specified|Non-Drug Treatment/Surgery for Actinic Keratosis|The count of participants in complete clearance(CC) group and Non-CC group who received non-drug treatment/surgery for actinic keratosis on the selected treatment area after Day 57 was collected.|from 57 days to 6 months|The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group /Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together.|||Participants|||Count of Participants
1307158|NCT02716714|Other Pre-specified|Medication for Actinic Keratosis|The count of participants in complete clearance(CC) group and Non-CC group who administered medication for actinic keratosis on the selected treatment area after Day 57 was collected.|from 57 days to 6 months|The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 was 67 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group and Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together.|||Participants|||Count of Participants
1307159|NCT02716714|Secondary|Time to Relapse in CC Group|Time to relapse in complete clearance(CC) Group was analyzed. Median survival time with 95% confidence interval was calculated by Kaplan-Meier method.|at 6 months|CC Group consisted of 54 participants who had at least 1 follow-up after achieving Complete Clearance of AK lesions on Day 57.|||days||95% Confidence Interval|Median
1307160|NCT02716714|Secondary|Cosmetic Outcomes Assessment (COA)|The investigator rated the subject’s Cosmetic Outcomes Assessment(COA) using 5 grades (Very good, Good, No change, Bad, Very bad), and results were as follows.|at 29 and 57 days from baseline|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||Participants|||Count of Participants
1307161|NCT02716714|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)|"Participants personally completed the tool to evaluate satisfaction with drug treatment. It consisted of 4 areas of Effectiveness, side effect, convenience, and global satisfaction, with a total of 14 sub-items. The full mark is 100, and it is divided in four stages as follows.~Very good: 76 -100 score~Good: 51-75 score~Not bad: 26-50 score~Bad: 0-25 score Scores for each area ranged from 0 to 100, with higher scores indicating that fewer side effects had occurred and greater treatment satisfaction."|at 29 and 57 days from baseline|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||units on a scale||Standard Deviation|Mean
1307440|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 4|Acne Lesion Count Total Global Face Week 4|4 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
1307162|NCT02716714|Secondary|Change From Baseline in Quality of Life (Skindex-29)|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores for each of the domains represents a better Quality of life.|at 29 and 57 days from baseline|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||units on a scale||Standard Deviation|Mean
1307163|NCT02716714|Secondary|Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group|Percentage change from baseline in the number of actinic keratiosis(AK) lesions at Month 6 in the selected treatment area in complete clearance(CC) Group was analyzed.|at 6 months from baseline|In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on day 57.|||Percentage change||Standard Deviation|Mean
1307164|NCT02716714|Secondary|Recurrence Rate in CC Group|Recurrence rate in complete clearance(CC) group was analyzed.|at 6 months|In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57.|||Participants|||Count of Participants
1307165|NCT02716714|Secondary|Sustained CC Rate in CC Group|Sustained Complete Clearance means that Complete Clearance was maintained until Month 6 in complete clearance (CC) group and sustained complete clearance(CC) rate at month 6 for complete clearance(CC) group was analyzed.|at 6 months|In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57.|||Participants|||Count of Participants
1307166|NCT02716714|Secondary|Percentage Change of the Number of AK Lesions in the Selected Treatment Area|Percentage change from baseline in the number of actinic keratiosis(AK) lesions in the selected treatment area on Day 57 was analyzed.|Baseline and Day 57|Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).|||percentage change||Standard Deviation|Mean
1307167|NCT02716714|Primary|CC Rate of AK Lesions in the Selected Treatment Area|Complete Clearance (CC) means that clearance of all visible AK lesions in the selected treatment area and Investigator-rated actinic keratiosis(AK) lesion complete clearance (CC) rate at the selected treatment area on day 57 was analyzed.|at day 57|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||Participants|||Count of Participants
1307168|NCT02716298|Primary|Surface Deposits|Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)|Baseline, 1 month|One participant excluded from analysis at 1 month.|||units on a scale||Standard Deviation|Mean
1307169|NCT02716298|Primary|Lens Wettability|Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)|Baseline, 1 month|One participant excluded from analysis at 1 month.|||units on a scale||Standard Deviation|Mean
1307170|NCT02716298|Primary|Subjective Preference|"Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B).~Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving."|1 month||||percentage of participants|||Number
1307171|NCT02716298|Primary|Subjective Comfort|Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).|Baseline, 1 month||||units on a scale||Standard Deviation|Median
1307172|NCT02714062|Secondary|Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)|Mean changes in glycemic parameters [Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT [glucose concentration (mg/dL) (fasting)*insulin concentration (uIU/mL) (fasting)*glucose concentration (mg/dL) (2 hours after glucose load)*insulin concentration (uIU/mL) (2 hours after glucose load)], with higher numbers indicating better insulin sensitivity.|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||Index||Standard Deviation|Mean
1307173|NCT02714062|Secondary|Change in HOMA-IR|Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||μIU/mL||Standard Deviation|Mean
1307174|NCT02714062|Primary|Maximum Concentration (Cmax) of Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||μg/mL||Standard Deviation|Mean
1307175|NCT02714062|Primary|Area Under the Curve (AUC) of Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||μg•h/mL||Standard Deviation|Mean
1307525|NCT02692859|Primary|Number of Participants With Solicited Adverse Reactions|Number of Participants with Solicited Adverse Reactions|0-7 days after each dose|A total of participants in aged 3-5 months,6-11months and 1-5years|||Count of Participants|||Number
1307176|NCT02714062|Secondary|Change in Visual Analog Scale (VAS) Satiety Scores|"Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors very satisfied” and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors not all at satisfied” and corresponds to a VAS satiety score of 10.0. Subjects were asked Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week: to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the 0.0 = very satisfied anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure."|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||units on a scale||Standard Deviation|Mean
1307177|NCT02714062|Secondary|Change in Visual Analog Scale (VAS) Hunger Scores|"Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors not at all hungry” and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors extremely hungry all the time” and corresponds to a VAS hunger score of 10.0. Subjects were asked Please mark with a perpendicular line on the scale how hungry you were overall during the past week: to best describes their overall level of hunger during the past week. Research staff measure the distance between the 0.0 = not at all hungry anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure."|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||units on a scale||Standard Deviation|Mean
1307178|NCT02714062|Secondary|Change in Lipid Parameters|Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||Percent Change||Standard Deviation|Mean
1307179|NCT02714062|Secondary|Change in OGTT of Fasting and 2-hour Glucose|Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||mg/dL||Standard Deviation|Mean
1307180|NCT02714062|Secondary|Change in Blood Pressure|Mean change in blood pressure from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||mmHg||Standard Deviation|Mean
1307181|NCT02714062|Secondary|Change in Waist Circumference|Mean change in waist circumference from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||cm||Standard Deviation|Mean
1307182|NCT02714062|Secondary|Weight Loss|Mean percent weight change from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||Percent weight change||Standard Deviation|Mean
1307183|NCT02714062|Primary|Maximum Concentration (Cmax) of Phentermine|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||ng/mL||Standard Deviation|Mean
1307184|NCT02714062|Primary|Area Under the Curve (AUC) of Phentermine|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||ng•h/mL||Standard Deviation|Mean
1307185|NCT02714062|Primary|Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||L||Standard Deviation|Mean
1307186|NCT02714062|Primary|Apparent Clearance (CL/F) of Phentermine and Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||L/h||Standard Deviation|Mean
1307187|NCT02713594|Secondary|Cost-effectiveness|This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.|Measured 6 months after enrollment||||U.S. Dollars|||Number
1307188|NCT02713594|Secondary|Engagement in Treatment|This analysis will compare number of calls completed|Measured 6 months after enrollment at follow-up assessment||||Participants|||Count of Participants
1307189|NCT02713594|Primary|Abstinence From Smoking|The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).|Measured 6 months after enrollment at follow-up assessment||||Participants|||Count of Participants
1307190|NCT02713256|Primary|Percentage of Participants Whose Free Thyroxine (Free T4) Levels Decrease After 12 Week Treatment|Percentage of participants whose free thyroxine (free T4) levels decrease after 12 weeks of treatment (DAY85). A decrease is when free T4 level is below Upper limit of normal (ULN) ≤ 22.7 pmol/L)|12 week (DAY 85)|Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders.|||percentage of participants|||Number
1307409|NCT02701361|Primary|Percent of Eligible Participants Who Provided Consent|Percent of eligible participants who provided consent. Because this includes eligible yet not-as-yet randomized participants, there are no study arm differences analyzed. This is a feasibility measure. Target is 70%.|pre-randomization|121, not 90 subjects, are analyzed because this outcome measure applies to a pre-consent and pre-randomization time period.|||Participants|||Count of Participants
1307191|NCT02713256|Primary|Percentage of Participants Whose Total Triiodothyronine (Total T3) Levels Decrease After 12 Week Treatment|Percentage of participants whose total triiodothyronine (total T3) levels decrease after 12 week treatment. A decrease is when total T3 level is below Upper limit of normal (ULN) ≤ 2.79 nmol/L|12 week (DAY 85)|Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders.|||percentage of participants|||Number
1307192|NCT02713256|Primary|Percentage of Participants Whose Thyroid Stimulating Hormone (TSH) Levels Normalize After 12 Week Treatment|Normalization of TSH is defined as TSH level greater than 0.35 mU/L after 12 week treatment (Day 85)|12 week (DAY 85)|Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders.|||percentage of participants|||Number
1307193|NCT02712333|Secondary|Pulse Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention||||mmHg||Standard Deviation|Mean
1307194|NCT02712333|Secondary|Diastolic Blood Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention||||mmHg||Standard Deviation|Mean
1307195|NCT02712333|Secondary|Systolic Blood Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention period||||mmHg||Standard Deviation|Mean
1307196|NCT02712333|Primary|Changes of Serum Norepinephrine Concentration|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention||||relative intensity||Standard Deviation|Mean
1307197|NCT02712333|Primary|Changes of Serum Epinephrine Concentrations|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of epinephrine with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention||||relative intensity||Standard Error|Mean
1307198|NCT02712333|Primary|Changes of Serum Cortisone Concentration|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of cortisone with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention period||||relative intensity||Standard Error|Mean
1307199|NCT02712333|Primary|Changes of Serum Cortisol Levels|"Using metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention period||||relative intensity||Standard Deviation|Mean
1307200|NCT02712099|Secondary|Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)|3D tomographic ultrasound imaging (TUI) of placenta previa with its lower edge covering the scar of previous cesarean section the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins|28 -36 weeks of gestation||||participants|||Number
1307201|NCT02712099|Secondary|Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)|the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins|28 -36 weeks of gestation||||participants|||Number
1307202|NCT02712099|Secondary|Abnormal Placental Lacunae by Power Doppler Ultrasonography|Power Doppler ultrasonography criteria by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
1307203|NCT02712099|Secondary|Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography|Power Doppler ultrasonography criteria of Crowded vessels over peripheral sub-placental zone of in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
1307204|NCT02712099|Primary|Abnormal Placental Lacunae by 2D Grayscale Ultrasonography|2D grayscale ultrasonography criteria of placenta accreta by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
1307205|NCT02712099|Primary|Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography|2D grayscale ultrasonography criteria of placenta accreta by Loss of the retro placental sonolucent zone in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
1307410|NCT02701296|Secondary|Sensation in the Peroneal Nerve Distribution|Self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
1307206|NCT02712047|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI|FEV1 is defined as the maximal amount of air which can be exhaled forcefully in one second. Three technically acceptable FEV1 measurements were made using a spirometer, and were measured on pre-dose on Day 1, taken pre-dose on Day 14 and every morning and evening until Day 19, and in the morning on Day 21. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant.|Baseline every morning and evening until Day 21 of each treatment period|PD Population|||Liter||Standard Deviation|Mean
1307207|NCT02712047|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI|The PEF is a lung function evaluation assessed using a PEF meter. It was defined as the maximum amount of air exhaled during forced exhalation with lungs fully inflated. For PEF measurements the best of the 3 recordings were recorded AM and PM (i.e every 12 hours), from Day-7 through to Day 29 of TP1, and then from Day 1 of TP2 through to the (29). Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Baseline and up to Day 29 in TP1; Baseline and up to follow up (Day 29) in TP2|PD population.|||Liter per minute||Standard Deviation|Mean
1307208|NCT02712047|Secondary|Change From Baseline in FeNO Over the FF/VI Treatment Period|In participants with asthma the FeNO is a non-invasive marker of airway inflammation. The FeNO was measured by the participants AM (pre-dose) and PM on Day -7 and all the way through Day 29 of each treatment period. The measurements were recorded using Niox Vero device provided at the site. These FeNO measurements were done throughout the treatment period. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Baseline and up to Day 29 in each treatment period|PD Population.|||Parts per billion||Standard Deviation|Mean
1307209|NCT02712047|Primary|Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI|FeNO is non-invasive marker of airway inflammation in asthma participants. It was measured by the participants, using Niox Vero device at AM (pre-dose) and PM on Day -7 and all way through Day 29 of each TP. The FeNO measurements were done over time following stop of repeat dose treatment with FF/VI. Change from Baseline was measured as ratio of post-dose visit value to Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline defined as the mean of Baseline across periods for each participant. Period level Baseline defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Summary of ratio from Baseline for exhaled nitric oxide reported as Geometric mean and Geometric coefficient of Variation. NA indicates data was not available.|Baseline and up to Day 29 in each treatment period|The Pharmacodynamic (PD) Population consisted of all the participants from the All Subject population who had at least one PD assessment.|||Ratio of exhaled Nitric Oxide||Geometric Coefficient of Variation|Geometric Mean
1307210|NCT02711995|Secondary|Aerodynamic Data- Maximum Phonation Time|Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ from which Maximum Sustained Phonation time was recorded.|Baseline and 30 days after intervention||||seconds (s)||Standard Deviation|Mean
1307211|NCT02711995|Secondary|Aerodynamic Data- Loudness|Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ and “We were away a year ago,” from which loudness was analyzed via the Maximum Sustained Phonation and Running Speech protocols.|Baseline and 30 days after intervention||||Decibel of sound pressure level (dB SPL)||Standard Deviation|Mean
1307212|NCT02711995|Secondary|Aerodynamic Data- Peak Air Pressure|Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. A string of five consonant-vowel syllables (/pa/) at a comfortable pitch and loudness were analyzed through the Voicing Efficiency protocol to determine mean peak air pressure.|Baseline and 30 days after intervention||||Centimeter of water (cm H2O)||Standard Deviation|Mean
1307213|NCT02711995|Secondary|Percent of Normal Function (PNF)|The Percent of Normal Function (PNF) is a scale for patients to rate their recurrent functions in increments of five, from no function (0%) to normal function (100%). The higher the percentage, the more normal the function as experienced by the patient.|Baseline and 30 days after intervention||||percentage of normal function||Standard Deviation|Mean
1307214|NCT02711995|Secondary|Voice Handicap Index-10 (VHI-10)|The Voice Handicap Index-10 consists of 10 questions (statements about voice), where patients rate their the frequency of their problems as: never (0), almost never (1), sometimes (2), almost always (3), and always (4). The scores from each answer are added, and can range from 0-40. The higher the score, the worse the patient's perception of their voice handicap.|Baseline and 30 days after intervention||||units on a scale||Standard Deviation|Mean
1307411|NCT02701296|Secondary|Dorsiflexion in the Peroneal Nerve Distribution|Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
1307215|NCT02711995|Secondary|Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)|"The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is used to describe the severity of auditory-perceptual attributes of a voice problem. It indicates salient perceptual vocal attributes: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. The CAPE-V displays each attribute accompanied by a 100- millimeter line forming a visual analog scale (VAS). The clinician indicates the degree of perceived deviance from normal for each parameter on this scale, using a tic mark. For each dimension, scalar extremes are unlabeled.~The scale range is from 0mm to 100mm. Results can indicate distance in mm to describe the degree of deviancy, so the higher the score the more deviancy from the norm there is."|Baseline and 30 days after intervention||||units on a scale||Standard Deviation|Mean
1307216|NCT02711995|Secondary|Aerodynamic Data- Airflow|Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ and “We were away a year ago,” from which mean airflow wasanalyzed via the Maximum Sustained Phonation and Running Speech protocols.|Baseline and 30 days after intervention||||Liters per second (L/s)||Standard Deviation|Mean
1307217|NCT02711995|Secondary|Acoustic Analysis- Frequencies|"For acoustic assessment, subjects produced a sustained /a/ sound at their habitual speaking pitch and loudness and read assessment sentences from the Consensus Audio-Perceptual Evaluation of Voice (CAPE-V)protocol. Tasks were recorded and analyzed using the Analysis of Dysphonia in Speech and Voice (ADSV) and Multi-Dimensional Voice Profile (MDVP) software. A handheld microphone 3 inches from the subjects’ mouths was used for all recordings.~The Sustained Vowel and All-Voiced Sentence protocols of the ADSV were used to obtain cepstral peak prominence fundamental frequency (CPP F0), The MDVP was used to obtain amplitude tremor frequency (Fatr), and fundamental frequency tremor frequency (Fftr)."|Baseline and 30 days after intervention||||Frequency (Hz)||Standard Deviation|Mean
1307218|NCT02711995|Primary|Vocal Tremor Scoring System (VTSS)|The Vocal Tremor Scoring System (VTSS) was developed to standardize the evaluation and scaling of vocal tremor. Tremor at a specific site was scored according to severity by the laryngologist. It can be rated as: none (0), mild/intermittent (1), moderate (2), severe (3). Six different regions were evaluated in this study: base of tongue, larynx, palate, pharyngeal walls, supraglottis, and true vocal folds. The scale range for each region was 0-3. The total score was a summation of all six regions, with a scalar range of 0-18.|Baseline and 30 days after intervention||||units on a scale||Standard Deviation|Mean
1307219|NCT02710630|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)|This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307220|NCT02710630|Secondary|Cmax (Maximum Plasma Concentration of Total Dabigatran)|This outcome measure presents maximum concentration of analyte in plasma (Cmax).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307221|NCT02710630|Secondary|AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307222|NCT02710630|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)|This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307223|NCT02710630|Primary|Cmax (Maximum Concentration of Free Dabigatran)|This outcome measure presents maximum concentration of analyte in plasma (Cmax).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307412|NCT02701296|Secondary|Cold Sensation in the Tibial Nerve Distribution|Self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
1307224|NCT02710630|Primary|AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307225|NCT02710292|Primary|Percentage of Subjects With Investigator-rated Lens Centration of “Optimal” After 10 Days of Wear|Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.|Day 10, each product|This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).|||percentage of subjects|||Number
1307226|NCT02710136|Secondary|Change in Log Base 10 Albumin in Nasal Secretions|Albumin is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the albumin level prior to the Nasal Allergen Challenge (NAC) from the albumin level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that albumin levels increased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline albumin measurement.|||mcg/L||Standard Deviation|Mean
1307227|NCT02710136|Secondary|Change in Log Base 10 Tryptase in Nasal Secretions|Tryptase is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the tryptase level prior to the Nasal Allergen Challenge (NAC) from the tryptase level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that tryptase levels increased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline tryptase measurement.|||mcg/L||Standard Deviation|Mean
1307228|NCT02710136|Secondary|Change in Visual Analogue Score|"Participants self-reported their score, reflecting the severity of their nasal symptoms-sneezing, runny nose, stuffy nose, itchy nose- on a Visual Analogue Scale (0 to 10 centimeters). The left-hand side of the scale (0) represents “No Symptoms,” and the right hand side of the scale (10) represents “As Bad as I Can Imagine.”~Change is computed by subtracting the VAS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the VAS score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that nasal symptoms increased over the course of the NAC."|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Centimeters||Standard Deviation|Mean
1307229|NCT02710136|Secondary|Change in Peak Expiratory Flow (PEF) L/Min|PEF is defined as the speed of expiration of air in Liters per minute when breathing out of the lungs. Change is computed by subtracting the PEF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PEF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that speed of expiration increased over the course of the Challenge, while a negative change score indicates speed of expiration decreased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||L/min||Standard Deviation|Mean
1307230|NCT02710136|Secondary|Change in Peak Nasal Inspiratory Flow (PNIF) L/Min|PNIF is defined as the speed of inspiration of air in Liters per minute when breathing into the lungs. Change is computed by subtracting the PNIF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PNIF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A negative change score indicates that speed of inspiration decreased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||L/min||Standard Deviation|Mean
1307231|NCT02710136|Secondary|Change in Total Nasal Symptom Score (TNSS)|TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Change is computed by subtracting the TNSS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge from the TNSS score obtained at the last tolerated dose of German cockroach allergen received during the Nasal Allergen Challenge (NAC). A positive change score indicates that nasal symptoms increased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Scores on a Scale||Standard Deviation|Mean
1307232|NCT02710136|Secondary|Highest Total Nasal Symptom Score (TNSS)|TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants provide a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. The highest TNSS observed after administration of any of the German cockroach allergen doses received during the Nasal Allergen Challenge (NAC) is summarized.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Scores on a Scale||Standard Deviation|Mean
1307246|NCT02708524|Primary|Overall Comfort Individual Item|Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1312574|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urethra||||Beats per minute||Standard Deviation|Mean
1307233|NCT02710136|Secondary|Number of Sneezes at Each of Nine Doses of German Cockroach Allergen|Nine increasing doses of German cockroach allergen (0, 0.00381, 0.01204, 0.0380, 0.120, 0.379, 1.20, 3.78, and 11.9 mcg/mL) were administered during the Nasal Allergen Challenge (NAC). After administration of each dose, the number of times the participant sneezed was recorded. Participants continued receiving doses of German cockroach allergen until threshold criteria described in the primary endpoint were met. Number of sneezes was carried forward for doses not received beyond the dose at which the threshold criteria were initially met. Number of sneezes is summarized at each dose.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Count of sneezes||Standard Deviation|Mean
1307234|NCT02710136|Primary|The Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Nasal Allergen Challenge (NAC)|The primary outcome in this study is the proportion of participants responding at each of 9 doses of cockroach allergen. To illustrate the variability of the primary outcome at each dose, the protocol specifies computation of 95% confidence intervals for the proportion responding at each dose. A proportion is to record for each patient a 0 for a non-responder and a 1 for a responder and compute the mean of the 0 and 1 values. The summary statistic for this method is a mean.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Cumulative proportion of participants||95% Confidence Interval|Mean
1307235|NCT02709577|Secondary|Absolute Weight Change||24 weeks or 52 weeks||||kg||Standard Deviation|Mean
1307236|NCT02709577|Primary|Change in HbA1c Values From Baseline Measurement|"Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline.~Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline."|Baseline to 24 weeks or 52 weeks||||percentage of HbA1c||Standard Deviation|Mean
1307237|NCT02709096|Primary|Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes|P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.|Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.|Per protocol population included all subjects with evaluable data and no major protocol violations.|||log change in colony forming units||Standard Deviation|Mean
1307238|NCT02708524|Secondary|Overall Opinion Individual Item|Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1307239|NCT02708524|Secondary|Overall Quality of Vision Individual Item|Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1307240|NCT02708524|Secondary|Subjective Overall Quality of Vision Composite Score|Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
1307241|NCT02708524|Primary|Making Your Eyes Feel Moist Throughout the Day Individual Item|Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1307242|NCT02708524|Primary|Frequency of Experiencing Dryness Individual Item|Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1307243|NCT02708524|Primary|Frequency of Lens Awareness Individual Item|Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1307244|NCT02708524|Primary|Comfort Each and Everyday Individual Item|Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1307245|NCT02708524|Primary|Comfort at the End of the Day Individual Item|Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
1307350|NCT02704689|Secondary|Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.|Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration.|Operative Visit|Subjects treated with the AccuLIF TL device|||minutes||Standard Deviation|Mean
1307247|NCT02708524|Primary|Subjective Overall Comfort Composite Score|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|All subjects that completed all study visits without a major protocol deviation.|||average clue score||Standard Deviation|Mean
1307248|NCT02708355|Primary|Change From Baseline at Day 14 in Percentage of Time Over 24-­Hour Period With Intra Gastric pH Greater Than (>)4|Percentage of time was calculated over the 24 hour period during which intra gastric pH >4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of “0” to the question “Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?” on at least 6 of the participant’s last 7 consecutive days [Days 8 – 14] of treatment allowing for one day with a maximum severity of “2”.The response was noted by participants in the diary for last 7 consecutive days [Day 8 – 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH >4 was observed, was reported.|Baseline, Day 14|Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.|||percentage of time||Standard Deviation|Mean
1307249|NCT02708355|Primary|Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn|Relief of 24 hour heartburn was defined as a daily diary response of “0” to the question “Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?” on at least 6 of the participant’s last 7 consecutive days [Days 8 – 14] of treatment allowing for one day with a maximum severity of “2”.The response was noted by participants in the diary for last 7 consecutive days [Day 8 – 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported.|Day 8 up to Day 14|Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.|||participants|||Number
1307250|NCT02708277|Secondary|Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||Within the first 3 months after surgery||||participants|||Number
1307251|NCT02708277|Secondary|Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound||Within the first 3 months after surgery||||mm||Standard Deviation|Mean
1307252|NCT02708277|Secondary|Menstruation Pattern(Improvement or No Significant Change) of All Participants|Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients|Within the first 3 months after surgery||||participants|||Number
1307253|NCT02708277|Primary|Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||three years||||participants|||Number
1307254|NCT02708238|Secondary|Number of Responders|Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline|28 days of treatment||||number of responders|||Number
1307255|NCT02708238|Primary|Median Daily Crying Time at the End of the Treatment|Median daily crying at the end of treatment (day 28).|28 days of treatment||||minutes||Full Range|Median
1307256|NCT02708212|Secondary|Overall Duration of BDE Examinations|The overall duration of both EGD and colonoscopy examinations was recorded and compared.|On the day of bidirectional endoscopy||||minutes||Standard Deviation|Mean
1307257|NCT02708212|Primary|Sedative Doses of Midazolam|During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.|On the day of bidirectional endoscopy procedures||||mg/kg||Standard Deviation|Mean
1307258|NCT02708212|Primary|Sedative Doses of Fentanyl|During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.|On the day of endoscopic procedures.||||mcg/kg||Standard Deviation|Mean
1307259|NCT02707952|Secondary|Percentage of Participants With Post-Treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1307260|NCT02707952|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1307366|NCT02702999|Primary|Number of Participants With Large for Gestational Age Fetuses||30 to 38 weeks gestational age||||Participants|||Count of Participants
1307367|NCT02702999|Primary|Number of Participants With Fetal Growth Restriction||30 to 38 weeks gestational age||||Participants|||Count of Participants
1307261|NCT02707952|Secondary|Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Subpopulations defined as Genotype 1 and 2 infected cirrhotic participants, prior direct acting antiviral agent (DAA) treatment experienced (T-exp) participants, Genotype 3, 4, 5 or 6-infected participants, and participants with severe renal impairment (RI). 95% CI was calculated using the Wilson score method.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1307262|NCT02707952|Secondary|Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. 95% CI was calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1307263|NCT02707952|Primary|Percentage of Participants in Arms A and B With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug, excluding participants with the Y93H polymorphism in NS5A at baseline (ITT-PS population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
1307264|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
1307265|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Deaths of All Causes||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
1307266|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
1307267|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
1307268|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Until 28 days from last dose of study treatment (Week 28)|mITT Population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
1307269|NCT02707640|Primary|Percentage of Participants With Early Treatment Discontinuations|Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
1307270|NCT02707640|Primary|Percentage of Participants With Dose Reductions|Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
1307271|NCT02707172|Primary|Amount of Diethylhexyl Phthalate Removed From Hand|Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.|immediately right after hand-washing|Each participant underwent two sets of experiments, one with placebo and one with intervention. 14 participants received placebo first and were crossed-over to received intervention. The other 14 participants received intervention first and were crossed-over to received placebo.|||percentage of DEHP removed||Standard Deviation|Mean
1307272|NCT02706717|Secondary|Tolerability|Tolerability was successfully completing the protocol-defined treatment period.|Treatment dispensation to Week 38|All enrolled participants who initiated study treatment.|||Participants|||Count of Participants
1307273|NCT02706717|Secondary|Safety|"Summary of the highest adverse event grade (0-5) for each participant.~Protocol definition of Adverse Events: 1) signs and symptoms Grade ≥3 and any that led to a change in treatment regardless of grade; 2) new diagnoses; 3) Grade ≥3 lab values and any that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade.~DAIDS AE Grading Table, Version 2.0 was used."|Treatment dispensation to Week 38|All enrolled participants who initiated study treatment.|||Participants|||Count of Participants
1307274|NCT02706717|Secondary|Change in I-FABP From Week 2 to Week 26.|I-FABP data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307275|NCT02706717|Secondary|Change in Microbial Diversity Shannon Index From Week 26 to Week 38.|Microbial diversity Shannon index data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 26 and 38||2018-12-31|12/2018||||
1307276|NCT02706717|Secondary|Change in Microbial Diversity Richness From Week 26 to Week 38.|Microbial diversity richness data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 26 and 38||2018-12-31|12/2018||||
1307277|NCT02706717|Secondary|Change in Microbial Diversity Shannon Index From Week 2 to Week 26.|Microbial diversity Shannon index data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307278|NCT02706717|Secondary|Change in Microbial Diversity Richness From Week 2 to Week 26.|Microbial diversity richness data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307279|NCT02706717|Secondary|Change in %CD8+CD28-CD57+ From Week 2 to Week 26.|%CD8+CD28-CD57+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307280|NCT02706717|Secondary|Change in %CD4+CD28-CD57+ From Week 2 to Week 26.|%CD4+CD28-CD57+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307281|NCT02706717|Secondary|Change in %CD8+CD38+HLA-DR+ From Week 2 to Week 26.|%CD8+CD38+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307282|NCT02706717|Secondary|Change in %CD8+HLA-DR+ From Week 2 to Week 26.|%CD8+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307283|NCT02706717|Secondary|Change in %CD8+CD38+ From Week 2 to Week 26.|%CD8+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307284|NCT02706717|Secondary|Change in %CD4+CD38+HLA-DR+ From Week 2 to Week 26.|%CD4+CD38+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307285|NCT02706717|Secondary|Change in %CD4+HLA-DR+ From Week 2 to Week 26.|%CD4+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307398|NCT02701361|Secondary|Change in Distress Associated With Physical Symptoms|The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 [none] to 30 [very troublesome]).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
1307286|NCT02706717|Secondary|Change in %CD4+CD38+ From Week 2 to Week 26.|%CD4+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307287|NCT02706717|Secondary|Change in %CD14lowCD16hi From Week 2 to Week 26|%CD14lowCD16hi data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307288|NCT02706717|Secondary|Change in %CD14+CD16+ From Week 2 to Week 26|%CD14+CD16+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307289|NCT02706717|Secondary|Change in %CD14+CD16- From Week 2 to Week 26.|%CD14+CD16- data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307290|NCT02706717|Secondary|Change in CD4+/CD8+ Ratio From Week 2 to Week 26.|Fold change was calculated as the value at Week 26 divided by the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||cells/mm^3 CD4+ : cells/mm^3 CD8+||95% Confidence Interval|Mean
1307291|NCT02706717|Secondary|Change in CD4+ Cell Count From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||cells/mm^3||95% Confidence Interval|Mean
1307292|NCT02706717|Secondary|Change in LBP From Week 2 to Week 26|LBP data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307293|NCT02706717|Secondary|Change in LPS From Week 2 to Week 26|LPS data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307294|NCT02706717|Secondary|Change in D-dimer From Week 2 to Week 26|"All values were log10 transformed prior to calculating change and conducting analyses.~Absolute change was calculated as the value at Week 26 minus the value at Week 2. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 D-dimer data were excluded.|||Fold change||95% Confidence Interval|Mean
1307295|NCT02706717|Secondary|Change in Kynurenine to Tryptophan Ratio From Week 2 to Week 26|Fold change was calculated as the value at Week 26 divided by the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||umol/L kynurenine : umol/L tryptophan||95% Confidence Interval|Mean
1307296|NCT02706717|Secondary|Change in Oxidized LDL From Week 2 to Week 26|Oxidized LDL data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307297|NCT02706717|Secondary|Change in sTNF-RI From Week 2 to Week 26|sTNF-RI data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307399|NCT02701361|Secondary|Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale|Depression symptoms were assessed with the PHQ-9, a 9-item scale (range 0 [no distress] to 27 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
1307298|NCT02706717|Secondary|Change in sCD163 From Week 2 to Week 26|sCD163 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307299|NCT02706717|Secondary|Change in IP-10 From Week 2 to Week 26|IP-10 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307300|NCT02706717|Secondary|Change in IL-6 From Week 2 to Week 26|IL-6 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26||2018-12-31|12/2018||||
1307301|NCT02706717|Primary|Change in sCD14 From Baseline to Week 25/26|"Baseline is defined as the average of the Entry and Week 2 values. Week 25/26 is defined as the average of the Week 25 and Week 26 values.~Absolute change was calculated as the value at Week 25/26 minus the value at Baseline."|Weeks 0, 2, 25, and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||ug/L||95% Confidence Interval|Mean
1307302|NCT02706327|Other Pre-specified|Vertical Jump Height Was Measured With a Special Mat|"Sensor mat was used in vertical jump measurement. The result is the distance (cm) that was jumped vertically and it is normalized by dividing the distance to length of subject in order to get percentage of jump distance.~Higher values mean better vertical jump performance. Participants were assessed after using the insoles for 8 weeks in order to get compliance.~Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.~Therefore, positive changes mean better score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.|||percentage of distance||Standard Deviation|Mean
1307303|NCT02706327|Other Pre-specified|Six-minute Walk Physiological Cost Index Was Calculated|"Physiological cost index was calculated by taking heart rate with finger oximeter and walking distance after a six-minute walk test.~The result is calculated by dividing one minute heart rate (beat) to walking distance (meter).~Lower values mean better physiological cost. Participants were assessed after using the insoles for 8 weeks in order to get compliance.~Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.~Therefore, negative changes mean better score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.|||beat/meter||Standard Deviation|Mean
1307304|NCT02706327|Other Pre-specified|Balance Was Assessed With a Dynamic Platform|"Dynamic platform was the equipment used in balance assessment. Participants were assessed after using the insoles for 8 weeks in order to get compliance.~Measurements were taken in the same day with and without insoles in shoes. The software calculates balance value between 0 and 5 that lower value means better balance score.~Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.~Therefore, negative changes mean better balance score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.|||units on a scale||Standard Deviation|Mean
1307305|NCT02706327|Secondary|Change in Quality of Life Assessed With Short Form-36 Scale|"The scale scores the health related quality of life with 0 and 100, minimum and maximum levels.~Each question is scored between 0-100 and the total score is found by dividing to number of question.~Higher score or positive change mean better quality of life in the scale. We used physical health part of it.~Changes were calculated as the difference between 8-week follow-up and baseline results."|Baseline and week 8||||units on a scale||Standard Deviation|Mean
1307306|NCT02706327|Primary|Change in Pain Intensity Measured by 100 mm Visual Analog Scale|"The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels.~Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week.~Changes were calculated as the difference between 8-week follow-up and baseline results."|Baseline and week 8||||milimiters||Standard Deviation|Mean
1307307|NCT02705807|Secondary|Change From Baseline in Cardiac Output (CO)|Cardiac output is the volume of blood pumped by the heart per minute. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||liter/minute||Standard Deviation|Mean
1307308|NCT02705807|Secondary|Change From Baseline in Pulmonary Vascular Resist (PVR)|The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||millimeter mercury/liter/minute||Standard Deviation|Mean
1307309|NCT02705807|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) and Mean Right Atrial Pressure (mRAP)|mPAP and mRAP are hemodynamic parameters. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT Population|||mmHg||Standard Deviation|Mean
1307400|NCT02701361|Primary|Number of Participant Clicks on Study Website|A usability measure obtained using Google Analytics.|baseline, end of study (approx. 4 months)||||clicks||Standard Deviation|Mean
1307310|NCT02705807|Secondary|Number of Participants With Change of WHO Functional Class From Previous Visit|WHO Functional Classification of physical activity limitations: I (no limitation) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Deteriorated (functional class increased). The change from baseline in WHO functional class at Week 4 has been presented in the table. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Up to Week 4|ITT population|||Participants|||Number
1307311|NCT02705807|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class|The WHO functional classes of PAH range from Class I (without limitation in physical activity) to Class IV (inability to perform a physical activity without any symptoms).|Baseline and Week 4|ITT population|||Participants|||Number
1307312|NCT02705807|Secondary|Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT Pro BNP)|Blood samples were collected at Baseline, 24 hours after the first dose of thermostable formulation of FLOLAN, and Week 4 for measurement of NT pro BNP. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||nanogram/liter||Standard Deviation|Mean
1307313|NCT02705807|Secondary|Number of Participants With the Reason for the Change Dose of the Thermostable Formulation of FLOLAN|All reasons for FLOLAN dose adjustments after the switch were listed.|Up to Week 4|ITT Population|||Participants|||Number
1307314|NCT02705807|Secondary|Number of Events to Adjust Dose of FLOLAN Based on the Change From Baseline to 3 Hours in Mean Pulmonary Artery Pressure (mPAP)|To assess the frequency of dose adjustment requirements based on the changes from baseline in mPAP up to 3 hours after dosing.The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Participants who gave consent to undergo right heart catheterisation (RHC) over 24-hour and at week 4 were assessed. Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Up to Week 4|ITT population|||Number of events|||Number
1307315|NCT02705807|Primary|Absolute Values of Oxygen Saturation|Oxygen saturation was measured by pulse oximetry at Baseline (BL), 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’).|Baseline and up to Week 4|ITT population|||Percentage||Standard Deviation|Mean
1307316|NCT02705807|Primary|Change From Baseline in Body Weight|Body weight was measured at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value. Participants with body weight outside and within the clinical concern reference range (<50kg) has been presented.|Baseline and Week 4|ITT population|||Participants|||Number
1307317|NCT02705807|Primary|Change From Baseline in Heart Rate|Heart rate was measured at Baseline, 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||Beats per minute (bpm)||Standard Deviation|Mean
1307318|NCT02705807|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured at Baseline, 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline, 1 hour, 3 hour, 24 hour and Week 4|ITT population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1307319|NCT02705807|Primary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings|A safety 12-lead ECG was performed at Baseline (BL), 24 hr after switching to the new Flolan diluent and Week 4 (W4). Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were reported. ECG abnormaility with respect to CS and NCS findings were judged by the investigator. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline, 24 hour and Week 4|ITT population|||Participants|||Number
1307320|NCT02705807|Primary|Number of Participants With the Indicated Urinalysis Findings|Urine protein, urine glucose, and occult blood were assessed at Baseline (BL) and Week 4 (W4). Dipstick test was performed for routine urinalysis. Abnormal values such as trace, 1+, 2+, 3+ and positive have been reported. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’).|Baseline and Week 4|ITT population|||Participants|||Number
1307321|NCT02705807|Primary|Absolute Values of Thyroid Stimulating Hormone at Baseline and Week 4|Blood samples were collected for measurement of Thyroid Stimulating Hormone (TSH) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||milliunits per litre (mU/L)||Standard Deviation|Mean
1307322|NCT02705807|Primary|Absolute Values of Free Triiodothyronine and Free Thyroxine at Baseline and Week 4|Blood samples were collected for measurement of Free Triiodothyronine (FT3) and Free Thyroxine (FT4) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||picomoles per litre (pmol/L)||Standard Deviation|Mean
1307323|NCT02705807|Primary|Absolute Values of Urea/Blood Urea Nitrogen, Glucose, Chloride, Sodium, Potassium, Magnesium, Phosphorus (Inorganic), and Calcium at Baseline and Week 4|Blood samples were collected for measurement of urea/Blood Urea Nitrogen (Urea/BUN), glucose, chloride, sodium, potassium, magnesium, phosphorus, inorganic, and calcium at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||Millimoles per litre (mmol/L)||Standard Deviation|Mean
1307401|NCT02701361|Primary|Visual Analog Satisfaction Scale|A measure of acceptability of the intervention. Target mean score is 75% or greater.|after intervention completion, up to 8 weeks post-randomization|measure was mistakenly omitted from study CRF and therefore data not collected.||||||
1307324|NCT02705807|Primary|Absolute Values of Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Gamma Glutamyltransferase, Lactate Dehydrogenase and Creatine Kinase at Baseline and Week 4|Blood samples were collected for measurement of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Gamma Glutamyltransferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase (CK) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||International units per liter (IU/L)||Standard Deviation|Mean
1307325|NCT02705807|Primary|Absolute Values of Total and Direct Bilirubin, Creatinine, and Uric Acid at Baseline and Week 4|Blood samples were collected for measurement of total and direct bilirubin, creatinine (CRT), and uric acid (UA) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||Micromoles per liter||Standard Deviation|Mean
1307326|NCT02705807|Primary|Absolute Values of Albumin and Total Protein at Baseline and Week 4|Blood samples were collected for measurement of albumin and total protein at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||G/L||Standard Deviation|Mean
1307327|NCT02705807|Primary|Absolute Values of Red Blood Cell Count at Baseline and Week 4|Blood samples were collected for measurement of red blood cells at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||terabinary/liter (Ti/L))||Standard Deviation|Mean
1307328|NCT02705807|Primary|Absolute Values of Platelet Count and White Blood Cell Count at Baseline and Week 4|Blood samples were collected for measurement of platelets and white blood cells (WBC) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||Giga/Liter (GI/L)||Standard Deviation|Mean
1307329|NCT02705807|Primary|Absolute Values of Hematocrit at Baseline and Week 4|Blood samples were collected for measurement of hematocrit values at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||Liter (L)||Standard Deviation|Mean
1307330|NCT02705807|Primary|Absolute Values of Hemoglobin at Baseline and Week 4|Blood samples were collected for measurement of hemoglobin values at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||Gram/Liter (G/L)||Standard Deviation|Mean
1307331|NCT02705807|Primary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in Blood at Baseline and Week 4|Blood samples were collected for the measurement of percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in blood at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hour (hr) prior to the first dose of the new diluent formulation (‘Visit 2 - Baseline’)|Baseline and Week 4|ITT population|||Percentage||Standard Deviation|Mean
1307332|NCT02705807|Primary|Number of Participants With Mild, Moderate or Severe AEs|Intensity for an AE and SAE is categorized as mild if an event is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate if an event is sufficiently discomforting to interfere with normal everyday activities; severe if that prevents normal everyday activities.|Up to Week 4|ITT population|||Participants|||Number
1307333|NCT02705807|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical interventions. Intention-to-Treat (ITT) population: comprised of all participants who have received at least one dose of the thermostable formulation of FLOLAN.|Up to Week 4|ITT population|||Participants|||Number
1307334|NCT02705716|Secondary|Change From Baseline in Tactile Threshold on Day 7 and 14|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, Day 7 and Day 14|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively.|||g||Standard Deviation|Mean
1307335|NCT02705716|Secondary|Change From Baseline in Schiff Sensitivity Score on Day 7|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 7|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 7.|||score on a scale||Standard Deviation|Mean
1307402|NCT02701361|Primary|Percentage of Self-directed MBT Sessions Attended by Eligible Participants|A feasibility measure. Target is 50% among those who neither dropped out nor died.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
1307336|NCT02705716|Primary|Change From Baseline in Schiff Sensitivity Score on Day 14|Schiff sensitivity score was assessed by examiner as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 14|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 14.|||score on a scale||Standard Deviation|Mean
1307337|NCT02705365|Secondary|Tobacco Treatment Use|Percentage of patients, comparing intervention and control groups, who during the 1-year study period had referral to Massachusetts Quitline, smoking cessation medication prescribed, or referral to in-person counseling.|Up to 1 year||||Participants|||Count of Participants
1307338|NCT02705365|Primary|Chest CT Completion|Percentage of patients assigned to the intervention and control groups who had at least one chest CT (according to billing and EMR data) during the 1-year study period.|Up to 1 year||||Participants|||Count of Participants
1307339|NCT02704689|Secondary|Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.|Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307340|NCT02704689|Secondary|Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.|Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307341|NCT02704689|Secondary|Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.|Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307342|NCT02704689|Secondary|Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.|Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307343|NCT02704689|Secondary|Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).|Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS).|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307344|NCT02704689|Secondary|Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.|Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307345|NCT02704689|Secondary|Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.|Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307346|NCT02704689|Secondary|Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings|Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307347|NCT02704689|Secondary|Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.|Medical Outcomes: Incidence of complications associated with the procedure and/or device.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
1307348|NCT02704689|Secondary|Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.|Surgical Outcomes: To measure the amount of blood loss at the time of surgery.|Operative Visit|Subjects treated with the AccuLIF TL device|||cc||Standard Deviation|Mean
1307349|NCT02704689|Secondary|Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.|Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days.|Peri-op|Subjects treated with the AccuLIF TL device|||days||Standard Deviation|Mean
1307351|NCT02704689|Primary|Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.|Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.|24 months|The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.||||||
1307352|NCT02704689|Primary|Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.|Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.|24 months|The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.||||||
1307353|NCT02704104|Other Pre-specified|Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication||Day 0|The overall number of patients is 46, 10 of whom were taking anti platelet therapy at the time of the procedure.|||seconds||Full Range|Median
1307354|NCT02704104|Secondary|Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30|The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and >40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.|7 and 30 Days Post Procedure|Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.|||wounds|||Number
1307355|NCT02704104|Secondary|Time to Hemostasis in Seconds Per Square Centimeter Wound Area|Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area|At time of application (Day 0)|Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.|||seconds/cm2||Full Range|Median
1307356|NCT02704104|Secondary|Median Time to Hemostasis (Seconds)|Measure of time from application of treatment or control to the wound, to bleeding cessation|At time of application (Day 0)|Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.|||seconds||Full Range|Median
1307357|NCT02704104|Primary|Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up|"Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up.~Systemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up."|30 Days Post Procedure||||Participants|||Count of Participants
1307358|NCT02703948|Primary|Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine||12 weeks||||Participants|||Count of Participants
1307359|NCT02703909|Secondary|Postoperative Opioid Requirement|The participants will be given iv fentanyl or hydromorphone after surgery. They will also be given po oxycodone. The investigators will collect data on the amount of opioid that is required after surgery. This will be reported as morphine equivalents using the morphine equivalent calculator at:|day of surgery until hospital discharge (approximately 2-3 days)|Only 24 of the patients had an IP of 10 mm throughout the surgery. The remainder of the patients either had IP of 15 mm throughout the surgery or were increased to 15 mm at the start of the surgery.|||morphine equivalents||Standard Deviation|Mean
1307360|NCT02703909|Secondary|Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure|The patients will be randomized to an initial insufflation pressure of 10 or 15 mm hg. If the surgeons are not satisfied with the initial operating conditions, the insufflating pressure will be increase to 15 mm Hg (if not already at that level). This will be reported as the percentage of patients who were able to have their entire surgery performed at an insufflation pressure of 10 mm Hg.|day of surgery|The percentage of patients who were able to have their surgery completed at an IP of 10 mm|||Participants|||Count of Participants
1307361|NCT02703909|Primary|Surgeon Satisfaction Scale|The surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions|day of surgery||||Scores on a scale||Standard Deviation|Mean
1307362|NCT02702999|Secondary|Number of Participants With Composite Maternal Morbidity|Composite Maternal Morbidity is defined as the presence of one of more of the following: 1) chorioamnionitis; 2) cesarean delivery in labor; 3) wound infection; 4) transfusion; 5) deep venous thrombus or pulmonary embolism; 6) admission to intensive care unit; 7) postpartum hemorrhage; or 8) death.|From time of delivery to discharge (average time of discharge is 4 days after delivery)|One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available.|||Participants|||Count of Participants
1307363|NCT02702999|Secondary|Number of Participants With Composite Neonatal Morbidity|Composite Neonatal Morbidity is defined as the presence of one or more of the following: 1) Apgar score < 5 at 5 min; 2) umbilical arterial pH < 7.00; 3) intraventricular hemorrhage grade III or IV; 4) periventricular leukomalacia; 5) intubation for over 24 hrs; 6) necrotizing enterocolitis grade 2 or 3; 7) stillbirth; or 8) death within 28 days of birth.|From time of delivery to discharge (average time of discharge is 4 days after delivery)|One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available.|||Participants|||Count of Participants
1307364|NCT02702999|Primary|Number of Participates With Polyhydraminos||30 to 38 weeks gestational age||||Participants|||Count of Participants
1307365|NCT02702999|Primary|Number of Participates With Oligohydraminos||30 to 38 weeks gestational age||||Participants|||Count of Participants
1307368|NCT02702921|Secondary|Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding|"Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS:~Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).~No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection)."|Post-Op through 4 Week Followup|A total of 229 subjects were screened and 201 subjects were randomized into the study – 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS stapler. These subjects are included in the PVS group for safety analysis.|||Proportion participants w/ intervention|Participant|95% Confidence Interval|Number
1307369|NCT02702921|Primary|Incidence of Intra-Operative Hemostatic Intervention|Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).|Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours|A total of 229 subjects were screened and 201 subjects were randomized into the study – 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS group. These subjects are included in the stapler group for the primary endpoint analysis, consistent with the intention-to-treat principle.|||Proportion transections w/ intervention|Vessels Transection|95% Confidence Interval|Number
1307370|NCT02702011|Primary|Change From Baseline in 24 Hour UGE on Day 7|Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.|Baseline and 7 days|The primary analysis was performed on the FAS with last observation carried forward (LOCF) imputation.|||gram per 24 hours (g/24 h)||Standard Error|Least Squares Mean
1307371|NCT02701985|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to Week 14|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||Percentage of participants|||Number
1307372|NCT02701985|Secondary|Average Concentration (Caverage) of RO5459072|Average observed plasma concentration (mass/volume)|Week 2, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||ng/mL||90% Confidence Interval|Median
1307373|NCT02701985|Secondary|Maximum Concentration (Cmax) of RO5459072|Maximum observed plasma concentration (mass/volume)|Week 2, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||ng/mL||90% Confidence Interval|Median
1307374|NCT02701985|Secondary|Minimum Concentration (Cmin) of RO5459072|Minimum observed plasma concentration (mass/volume)|Week 2, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||ng/mL||90% Confidence Interval|Median
1307375|NCT02701985|Secondary|Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12|Total IgM is a type of auto-antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||g/L||Standard Deviation|Mean
1307376|NCT02701985|Secondary|Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12|Total IgG is a type of auto-antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||g/L||Standard Deviation|Mean
1307377|NCT02701985|Secondary|Change From Baseline in Rheumatoid Factor at Weeks 6, and 12|Rheumatoid factor is a type of auto-antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||kU/L||Standard Deviation|Mean
1307378|NCT02701985|Secondary|Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12|Anti-Sjögren's-syndrome-related antigen B is a type of antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||U/mL||Standard Deviation|Mean
1307379|NCT02701985|Secondary|Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12|Anti-Sjögren's-syndrome-related antigen A is a type of antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||U/mL||Standard Deviation|Mean
1307403|NCT02701361|Primary|Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys|A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
1307404|NCT02701361|Primary|Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews|Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
1307380|NCT02701985|Secondary|Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12|Change from baseline in mechanically stimulated salivary flow rate is defined as the change in flow (mL/min) between baseline (Week -1) and Week 2, Week 6 and Week 12. Using a mechanical stimulation method of a piece of neutral wax, paraffin, silicone, unflavored chewing gum, or similar chewable, unflavored, nonabsorbent material, patients were instructed to chew for a period of 5 minutes. The stimulated salivary flow rate was calculated assuming a specific gravity of 1 (i.e., 1 mL saliva = 1 g) and expressed in mL per minute.|Baseline, Week 2, Week 6, and Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||mL/min||Standard Deviation|Mean
1307381|NCT02701985|Secondary|Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12|Un-stimulated tear production rate was measured from both eyes (without the use of analgesics/ anesthetic drops) at baseline and at on-treatment visits using the Schirmer method. A thin strip of filter paper (Schirmer strip, e.g., 35 x 5 mm) was placed at the junction of the lateral and middle thirds of the lower eyelid of each eye. The maximum length of wetting along the strip at the end of the test period was measured.|Baseline, Week 2, Week 6, and Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||mm/5 min||Standard Deviation|Mean
1307382|NCT02701985|Secondary|Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) pain component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren’s syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (Each domain scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
1307383|NCT02701985|Secondary|Change From Baseline in ESSPRI Fatigue Component Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) fatigue component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren’s syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
1307384|NCT02701985|Secondary|Change From Baseline in ESSPRI Dryness Component Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) dryness component score is defined as the change in score between baseline (Week -1) and Week 12. The Dryness Component score ranged from 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
1307385|NCT02701985|Secondary|Change From Baseline in SF-36 Physical Score at Week 12|Change from baseline in Short Form-36 Health Survey (SF-36) Physical Score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100. (a score of 0 = maximum disability and a score of 100 = no disability)|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
1307386|NCT02701985|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12|Change from baseline in Short Form-36 Health Survey (SF-36) Mental score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100 (a score of 0 = maximum disability and a score of 100 = no disability). Reported here is the mental health domain score.|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
1307387|NCT02701985|Secondary|Change From Baseline in ESSPRI Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren’s syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren’s syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight.|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
1307405|NCT02701361|Primary|Percent of Randomized Participants Who Drop Out of Study|A feasibility measure. Target is 20% or less.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
1307406|NCT02701361|Primary|System Usability Scale (SUS)|Usability of the mobile app was assessed with open-ended participant feedback and with the 10-item System Usability Scale (SUS; 0 [lowest] to 100 [highest]). A SUS score above a 68 would be considered above average and anything below 68 is below average.|1 month post-randomization||||units on a scale||Standard Deviation|Median
1307388|NCT02701985|Secondary|Change From Baseline in ESSDAI Score at Week 12|Change from baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSDAI is a physician-assessed disease activity index for primary Sjögren’s syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific ‘domains’ contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||scores on a scale||Standard Deviation|Mean
1307389|NCT02701985|Secondary|Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score|The efficacy of RO5459072 in patients with primary Sjogren's Syndrome Disease is evaluated in terms of the percentage of participants with a clinically relevant decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score, where a clinically relevant decrease in ESSPRI score is defined as a decrease of ≥ 1 point. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren’s syndrome developed by the EULAR consortium. It consists of 3 questions covering cardinal symptoms of Sjögren’s syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains where all domains carry same weight.|12 weeks|mITT population was defined as all randomized participants, who received any study medication and had evaluable measument of the parameter of interest at baseline and at least one post-baseline visit.|||Percentage of Participants||95% Confidence Interval|Number
1307390|NCT02701985|Primary|Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score|Percentage of participants with a clinically relevant decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as participants with absolute decrease of ≥ 3-points in ESSDAI score. ESSDAI is physician-assessed disease activity index developed by EULAR consortium consisting of 44 items in 12 organ-specific ‘domains’ (constitutional,lymphadenopathy, articular,muscular,cutaneous,glandular,pulmonary,renal,peripheral nervous system,central nervous system,hematological,biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A score ≥ 5 is considered moderate or severe disease activity and a clinically relevant change in ESSDAI score is defined as absolute decrease of ≥ 3-points.|12 weeks|Modified intent-to-treat (mITT) population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Percentage of Participants||95% Confidence Interval|Number
1307391|NCT02701556|Primary|The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.|A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test – Control) in proportions of slit lamp outcomes. Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).|3 months||||Participants|||Count of Participants
1307392|NCT02701387|Primary|Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone|"Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows:~Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8)"|Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)|Seven participants, each missing at least two posterior teeth in the same arch, were enrolled, resulting in 10 matched pairs for analysis. Outcome was assessed per implant, not per individual participant;|||units on a scale|implants|Standard Deviation|Mean
1307393|NCT02701361|Other Pre-specified|Usability Themes Developed From Semi-structured Participant Interviews|A usability measure. Open-ended feedback questions will be arranged in themes.|end of study|||||||
1307394|NCT02701361|Secondary|Change in the Avoidance Domain of the Brief COPE Scale|Coping skills were measured with the Brief COPE scale (range 10 [low use] to 40 [highest use]). The Brief COPE is a self-report questionnaire used to assess a number of different coping behaviors and thoughts a person may have in response to a specific situation.|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
1307395|NCT02701361|Secondary|Change in Psychological Distress Symptoms as Measured by the PTSS|The Post Traumatic Stress Scale (PTSS), a 10-item scale (range 10 [no symptoms] to 70 [high burden of symptoms]), was used to assess PTSD symptoms; >20 represents clinically important symptoms.|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
1307396|NCT02701361|Secondary|Change in Psychological Distress Symptoms as Measured by the GAD-7|Anxiety symptoms were measured using the Generalized Anxiety Disorder 7-item scale (GAD-7; range 0 [no distress] to 21 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
1307397|NCT02701361|Secondary|Change in Mindfulness Skills|Mindfulness skills were measured with the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 12-item measure of mindful qualities (range 12 [low ability] to 48 [highest ability]).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
1312575|NCT02502487|Secondary|Heart Rate Before Gel Administration||before gel administration||||Beats per minute||Standard Deviation|Mean
1307418|NCT02699892|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant’s disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: (0.56*√TJC)+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28</=3.2; reduction of DAS28 >1.2.|Baseline, Weeks 24, 48 and 72|"ITT Population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point."|||Percentage of participants|||Number
1307419|NCT02699892|Primary|Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion|DAS28 score is a measure of participant’s disease activity calculated using tender joint count [28 joints] (TJC28), swollen joint count [28 joints] (SJC28), participant’s global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: [0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of greater than (>) 3.2 to </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.|Baseline, 24 weeks after first rituximab infusion (Week 24)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||Percentage of participants|||Number
1307420|NCT02699684|Secondary|Change From Insertion in Minimum Protected Area (MPA)|MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.|Hour 0 (Lens Insertion) to Hour 12 on Day 1|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
1307421|NCT02699684|Secondary|Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear|The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.|Day 30, each product|Full Analysis Set. Only the right (OD) lenses were collected from a subset of subjects.|||μg||Standard Deviation|Mean
1307422|NCT02699684|Primary|Percentage of Subjects Satisfying the “no Re-fit” Criteria in Both Eyes|Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.|Day 30, each product|Full Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||percentage of subjects|||Number
1307423|NCT02699632|Secondary|Concerns for Participating in Research While Pregnant|Survey question: What concerns might make you hesitant to participate in a research study while pregnant?|Day 1||||Participants|||Count of Participants
1307424|NCT02699632|Secondary|Comfort of Participating in Research While Pregnant|Survey question: Would you feel comfortable participating in a research study while pregnant?|Day 1||||Participants|||Count of Participants
1307425|NCT02699632|Secondary|Preferred Methods for Learning About a Research Study|Survey respondents were asked how they would prefer to learn about a research study with several answers cited.|Day 1||||Participants|||Count of Participants
1307426|NCT02699632|Primary|Willingness to Participate in Research While Pregnant|Survey question: What types of research would you be willing to participate in while you were pregnant?|Day 1|part 1 of question observational studies; part 2 of question retrospective studies; part 3 of question lifestyle interventions in pregnancy|||Participants|||Count of Participants
1307427|NCT02699593|Primary|Visual Acuity (LogMAR)|Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.|2-week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Eyes|Standard Deviation|Mean
1307428|NCT02699593|Primary|Contact Lens Wearing Time|Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.|2-week follow-up|Subjects that completed all study visits without a major protocol deviation.|||Hours||Standard Deviation|Mean
1307429|NCT02698566|Primary|Percentage of PFS Usage Errors on Essential Tasks|Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Essential tasks were those that were required in order to complete the use process for effective use of the product.|Day 1|Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.|||percentage of usage errors|ITV injections||Number
1307430|NCT02698566|Primary|Percentage of PFS Usage Errors on Safety Critical Tasks|Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Safety critical tasks where those in which use error could have a reasonably foreseeable potential for clinical impact or harm.|Day 1|Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.|||percentage of usage errors|ITV injections||Number
1307441|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 2|Acne Lesion Count Total Global Face Week 2|2 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
1307431|NCT02698566|Primary|Percentage of Successful Task Completions|Product use tasks included sequence of steps starting from opening the carton, removing contents from carton to disposing of used PFS and needle. Tasks were considered to be successfully completed if the correct results were achieved without a use error, even if the instructions for use (IFU) were not followed exactly (example: not removing the needle cap prior to adjusting a dose). Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. The ability of HCPs to follow the IFU to prepare and administer a ranibizumab PFS ITV injection dose to patients was evaluated by successful task completion.|Day 1|Three HCPs referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.|||percentage of tasks|ITV injections||Number
1307432|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 12|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|12 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
1307433|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 8|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|8 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
1307434|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 4|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|4 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
1307435|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 2|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|2 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
1307436|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 1|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|1 Week|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
1307437|NCT02698436|Secondary|Investigator Global Acne Assessment - Baseline|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|Baseline|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
1307438|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 12|Acne Lesion Count Total Global Face Week 12|12 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
1307439|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 8|Acne Lesion Count Total Global Face Week 8|8 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
1314210|NCT02454959|Secondary|AUC0-12 on Day 8|Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h*pg/mL||Standard Deviation|Mean
1307442|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 1|Acne Lesion Count Total Global Face Week 1|1 Week|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
1307443|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Baseline|Acne Lesion Count Total Global Face at Baseline|Baseline|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
1307444|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8||Baseline to 8 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
1307445|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4||Baseline to 4 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
1307446|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2||Baseline to 2 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
1307447|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1||Baseline to 1 Week|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
1307448|NCT02698436|Primary|Percent Change of Global Face Total Acne Lesion Count From Baseline||Baseline to 12 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
1307449|NCT02698423|Secondary|Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.|Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.|1 year||||Participants|||Count of Participants
1307450|NCT02698423|Primary|Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing|Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.|1 year||||Participants|||Count of Participants
1307451|NCT02697890|Secondary|Keratinized Tissue Width (mm)|Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans.|4 months after surgical procedure||||mm||Standard Deviation|Mean
1307452|NCT02697890|Secondary|Changes in Soft Tissues|Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.|4 months after surgical procedure||||mm||Standard Deviation|Mean
1307453|NCT02697890|Secondary|Changes in Hard Tissues|Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.|4 months after surgical procedure||||mm||Standard Deviation|Mean
1307454|NCT02697890|Primary|Changes in Alveolar Bone (mm)|Width of Alveolar Bone at 4, 7, and 10mm heights apical to the CEJ buccally and lingually. Mean of overall buccal and lingual/palatal height (reference hole to buccal and lingual bone top).Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans|4 months after surgical procedure||||mm||Standard Deviation|Mean
1307455|NCT02696317|Secondary|Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)|MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
1307456|NCT02696317|Secondary|Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)|MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
1307457|NCT02696317|Secondary|Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)|Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||10^-7g/cm^2/s|Eyes|Standard Deviation|Mean
1307478|NCT02695290|Secondary|Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)|Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.|Up to 98 days|All data collected from the single patient who received study medication. As none of the AEs led to the dose reduction hence time to first dose reduction is not applicable.||||||
1338037|NCT01968135|Secondary|Number of Days to Recurrence of Bleeding After Discontinuation of Therapy||Up to six months||||days||Full Range|Median
1307458|NCT02696317|Primary|Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)|Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||10^-7g/cm^2/s|Eyes|Standard Deviation|Mean
1307459|NCT02696291|Secondary|Accumulation Ratio (AR)|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. AR is derived from individual subject plasma concentration-time data, calculated as AUC(0-8) after the last dose divided by AUC(0-8) after the first dose. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||||Geometric Coefficient of Variation|Geometric Mean
1307460|NCT02696291|Secondary|Apparent Terminal Half Life (t1/2)|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of t1/2 are derived from individual subject plasma concentration-time data, calculated as ln2/λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||h||Full Range|Median
1307461|NCT02696291|Secondary|Apparent Volume of Distribution of UV-4 During the Terminal Phase (Vz/F) After Multiple Doses|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Vz/F are derived from individual subject plasma concentration-time data, calculated as CL/F divided by λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||L||Geometric Coefficient of Variation|Geometric Mean
1307462|NCT02696291|Secondary|Apparent Systemic Clearance (CL/F) at Steady State|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of CL/F are derived from individual subject plasma concentration-time data, calculated as dose (free-base equivalent) divided by AUC(0-8). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1307463|NCT02696291|Secondary|Area Under the Concentration-time Curve From Time Zero (Predose) Until 8 Hours After the Final Dose [AUC(0-8)]|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-8) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 1, Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1307464|NCT02696291|Secondary|Total Daily Exposure at Steady State: Area Under the Concentration-time Curve From Time Zero (Predose) Until 24 Hours After the Last Dose [AUC(0-24)]|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-24) are derived from individual subject plasma concentration-time data, calculated as AUC(0-8) x 3 (Day 7 last dose only). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1307465|NCT02696291|Secondary|Area Under the Concentration-time Curve From Time Zero (Predose) to Time of the Last Quantifiable Concentration After the Last Dose [AUC(0-last)]|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-last) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1307479|NCT02695290|Secondary|Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)|Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).|Up to 98 days|Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication. All data collected from the single patient who received study medication.|||Percentage of Participants|||Number
1307466|NCT02696291|Secondary|Time of Maximum Plasma Concentration (Tmax)|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of tmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 1, Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||h||Standard Deviation|Mean
1307467|NCT02696291|Secondary|Maximum Plasma Concentration (Cmax)|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Cmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 1, Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307468|NCT02696291|Secondary|Number of Subjects With 12-lead Electrocardiogram (ECG) Abnormalities Postdose by Group|ECGs (ventricular heart rate, wave intervals - PR, QRS, QT, QTcF) were recorded in a supine position (for at least 10 minutes). Baseline was calculated from the average of the triplicate ECGs on Day 1 predose. Within each parameter, subjects having multiple abnormalities are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
1307469|NCT02696291|Secondary|Number of Subjects With Outlying Vital Sign Results by Group|Vital signs of blood pressure (BP), pulse, respiratory rate, and oral temperature were taken after being supine for 10 minutes. Orthostatic vital signs (BP, pulse) were taken after 2 minutes standing. Vital sign results are presented as the number of subjects having Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the FDA Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007), or having abnormal orthostatic change (standing minus supine result). Within each parameter, subjects having multiple abnormalities are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
1307470|NCT02696291|Primary|Number of Subjects With Clinical Laboratory Abnormalities of Toxicity Grade 1 or Higher by Group|Clinical laboratory abnormalities are presented as the total of Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the Food and Drug Administration (FDA) Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) and the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (November 2007). Within each parameter, subjects having multiple abnormalities are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
1307471|NCT02696291|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) by Group|The incidence of SAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple SAEs are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
1307472|NCT02696291|Primary|Number of Subjects Reporting Treatment-emergent Adverse Events (TEAEs) by Group|The incidence of TEAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple TEAEs are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
1307473|NCT02696226|Primary|Leaflet Motion|Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (>70% reduction), or immobile (lack of motion of at least one valve leaflet).|4-6 weeks post procedure|Study terminated||||||
1307474|NCT02696083|Primary|Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90|Synovial markers measured included bone morphologic proteins, related proteins Activin A, Osteoactivin, sonic hedgehog, Dickkopf, interleukin cytokines and tumor necrosis factor alpha, Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1. Inflammation related proteins assayed were monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine. Adhesion and matrix metalloproteinase proteins levels were also determined. The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).|Baseline, Days 45 and 90|The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).|||protein markers|protein markers||Count of Units
1307475|NCT02696070|Primary|Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60|The mean percent change in intraepidermal nerve fiber density mean values for mean nerve fibers per millimeter squared from baseline to Day 60 was calculated for each treatment group (value at 60 days minus value at baseline).|60 days||||nerve fibers / mm squared||Standard Deviation|Mean
1307476|NCT02695446|Secondary|Skin/Dermal Levels of Minocycline||Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules||||ng/ml||Full Range|Mean
1307477|NCT02695446|Primary|Plasma Minocycline Level||Assessed at week 2 and week 4; reported at week 4||||ng/ml||Standard Deviation|Mean
1307491|NCT02694718|Secondary|Number of Participants With Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities is reported.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.|||Participants|||Number
1307480|NCT02695290|Primary|Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib|Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.|Up to 98 days|Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication.|||Pecentage of Participants||95% Confidence Interval|Number
1307481|NCT02694978|Secondary|Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5|Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) – Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.|Baseline (Day 1), Week 5|ITT population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.|||g/dL||Standard Deviation|Mean
1307482|NCT02694978|Secondary|Mean Change In Hemoglobin From Baseline To Week 5|Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) – Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.|Baseline (Day 1), Week 5|Intent-to-treat (ITT) population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.|||g/dL||Standard Deviation|Mean
1307483|NCT02694978|Secondary|Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death|"All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC).~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Day 1 (after first dosing) through Week 5|The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.|||Participants|||Count of Participants
1307484|NCT02694978|Primary|Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension|"All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure.~Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Day 1 (after first dosing) through Week 5|The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.|||Participants|||Count of Participants
1307485|NCT02694744|Secondary|Mean Change in Serum Potassium From Baseline to Week 4|An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.|Baseline to Day 28|Only intent-to-treat subjects who were available at both Baseline and Week 4 visits.|||mEq/L||Standard Error|Least Squares Mean
1307486|NCT02694744|Primary|Percentage of Subjects With Serum Potassium in the Target Range (3.8 – 5.0 mEq/L) at Either Week 3 or Week 4||21 to 28 Days|The intent-to-treat (ITT) population for efficacy analyses includes all subjects who have been randomized and have taken at least one dose of patiromer.|||percentage of participants||95% Confidence Interval|Number
1307487|NCT02694718|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.|||Participants|||Number
1307488|NCT02694718|Secondary|Percentage of Participants With Pathological Incomplete Tumor Response|Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.|Up to Week 16|ITT population included all participants, who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1307489|NCT02694718|Secondary|Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes|Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).|From screening to Week 16|ITT population included all participants, who received at least one dose of study drug.|||Percentage of participants|||Number
1307490|NCT02694718|Secondary|Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer|R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.|Up to Week 16|The ITT consists of all included participants, who received at least one dose of study drug. Five participants from ITT population with T4 rectal cancer underwent surgery.|||Percentage of participants|||Number
1314901|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN||96 weeks||||participants|participants||Number
1307492|NCT02694718|Secondary|Percentage of Participants With Sphincter-preservation|Percentage of participants with sphincter-preservation is reported.|Up to Week 16|ITT population included all participants, who received at least one dose of study drug. Two participants from the ITT population did not undergo surgery (one died, one withdrew consent).|||Percentage of participants|||Number
1307493|NCT02694718|Primary|Percentage of Participants With Pathological Complete Tumor Response|Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).|Up to Week 16|The intent to treat (ITT) population included all participants, who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1307494|NCT02694601|Secondary|Plasma Triglyceride Concentrations|Triglycerides (mM)|4 hours||||mmol/L||Standard Error|Mean
1307495|NCT02694601|Secondary|Plasma Cholesterol Concentrations|Total cholesterol (mM)|4 hours||||mmol/L||Standard Error|Mean
1307496|NCT02694601|Secondary|Plasma Glucose Concentrations|Glucose (mM)|4 hours||||mmol/L||Standard Error|Mean
1307497|NCT02694601|Primary|Plasma Beta-hydroxybutyrate Concentrations|Beta-hydroxybutyrate (uM)|4 hours||||µmol/L||Standard Error|Mean
1307498|NCT02694601|Primary|Plasma Acetoacetate Concentrations|Acetoacetate (uM)|4 hours||||µmol/L||Standard Error|Mean
1307499|NCT02694549|Secondary|Secondary Safety Endpoint|Safety: Incidence of all adverse events at 30 days|30 days||||Participants|||Count of Participants
1307500|NCT02694549|Primary|Primary Performance Endpoint|Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site|30 days||||Participants|||Count of Participants
1307501|NCT02694549|Primary|Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).||30 days||||Participants|||Count of Participants
1307502|NCT02694536|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||months||95% Confidence Interval|Median
1307503|NCT02694536|Secondary|Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||percentage of participants|||Number
1307504|NCT02694536|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||months||95% Confidence Interval|Median
1307505|NCT02694536|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported to the nearest integer.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||percentage of participants|||Number
1307506|NCT02694536|Secondary|European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores|"The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 (no/not at all) to 4 (very much) where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 (very poor) to 7 (excellent) where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available."|Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1307507|NCT02694536|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.|Up to approximately 40 months (assessed continuously during treatment)|Safety Population|||percentage of participants|||Number
1307522|NCT02692859|Secondary|Incidence of Serious Adverse Event (SAE) During the Whole Study Period||0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y|||||||
1307523|NCT02692859|Secondary|Incidence of Unsolicited Adverse Reactions||0-28 days after each dose|||||||
1307524|NCT02692859|Primary|Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml||28 days after full course of vaccination||2017-12-31|12/2017||||
1314902|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN||96 weeks||||participants|participants||Number
1307508|NCT02694315|Primary|Bishop Score Prior to Induction of Labor|"median Bishop score assessed by digital vaginal examination as follows:~Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion.~Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more.~Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more.~Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft.~Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.~Note that a score more than 10 means patient is in labor not needing induction of labor."|72 hours||||units on a scale||Inter-Quartile Range|Median
1307509|NCT02694315|Primary|Cervical Length Prior to Labor Induction|median cervical length measured by transvaginal ultrasound in centimetres|24 hours||||centimetres||Inter-Quartile Range|Median
1307510|NCT02694198|Primary|Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion|Difference between women who expulsed the fetus within 24 hours and women who expulsed the fetus in more than 24 hours as regarding cervicovaginal fetal fibronectin level (ng/ml)|72 hours||||nanogram per milliliter||Standard Deviation|Mean
1307511|NCT02694198|Primary|Cervicovaginal Fetal Fibronectin Level|mean cervicovaginal fetal fibronectin level in women undergoing midtrimesteric induction of abortion|72 hours|Depending on Francesco et al., 2005 who found that Fetal fibronectin test positive in 19 among 270 (7.0%) women undergoing mid-trimester abortion. Assuming α=0.05 and confidence interval (CI)= 10.0% and by using PASS 11th release the minimal sample size is 120. With a possible 10% drop out of cases, the enrolled cases would be 135 cases.|||nanogram per milliliter||Standard Deviation|Mean
1307512|NCT02693704|Primary|Listener's Subjective Preference|Listeners compare two audiovisual stimuli (diotic and spatialized) and Indicate their preference between binaural diotic (no spatialization), spatialized stimuli, or no preference. Results are given as the percentage of participant for the 3 possible answers in each group.|1 day of the experiment||||Percentage of participants|||Number
1307513|NCT02693704|Primary|Speaker's Localization|"Localization error (in number of spatial sectors)~For each group: average localization error over all subjects in the group. It is the difference between the actual spatial sector and the one reported by the listeners. There were 5 spatial sectors, and 9 possible locations. For instance: if the stimuli is played in sector 4, and the listener perceives it in 2, then the localization error is |4-2| = 2. The goal is to compare the localization error in 3 conditions: 1/ with no hearing aids (reference of natural localization) and no spatialization 2/ with hearing aids and standard fittings and no spatialization, and 3/ with spatialization applied."|1 day of the experiment||||Localization error (# spatial sectors)||Standard Deviation|Mean
1307514|NCT02693704|Primary|Speech Intelligibility|Speech recognition score (%) For each group: average of the SRS over all subjects in the group. The SRS correspond to the number of understood words in a sequence of sentences (French HINT database) mixed with several level of masking noise (speech-shaped noise). Some are played diotically, the other are spatialized in various directions. The goal is to ensure that the spatialization processing does not degrade the understanding of the speech.|1 day of the experiment||||Percentage of understood word||Standard Deviation|Mean
1307515|NCT02693002|Secondary|B-type Natriuretic Peptide (BNP) Levels|Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time.|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
1307516|NCT02693002|Secondary|Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)|"Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates Not true of me and 5 indicates an answer of mostly true. Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for Occupational, 31 points for Health, 28 points for Emotional and 15 points for Sexual for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time."|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
1307517|NCT02693002|Secondary|Activity Level Assessed by Duke Activity Status Index (DASI)|"Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a No answer or awarded a fixed number of points ranging from 1.75-8 for a Yes answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks."|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
1307518|NCT02693002|Primary|Diastolic Function Assessed by Echocardiography|Change in diastolic function as assessed by echocardiography from baseline to 12 weeks|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
1307519|NCT02692859|Secondary|the Anti-PRP Geometric Mean Fold Increase (GMFI)||28 days after full course of vaccination|||||||
1307520|NCT02692859|Secondary|the Anti-PRP Geometric Mean Concentrations (GMCs)||28 days after full course of vaccination|||||||
1307521|NCT02692859|Secondary|Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml||28 days after full course of vaccination|||||||
1307526|NCT02692703|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks)|All participants who received at least 1 dose of study drug, completed treatment, had HCV RNA <LLOQ at the final treatment visit, and had post-treatment data available, excluding reinfection.|||percentage of participants|||Number
1307527|NCT02692703|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to 12 weeks|ITT population|||percentage of participants|||Number
1307528|NCT02692703|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 compared with the historical SVR12 rate for the current standard of care regimens (sofosbuvir [SOF]/ledipasvir [LDV] + ribavirin [RBV] OR SOF + daclatasvir [DCV] + RBV). Participants with missing data after backward imputation were counted as non-responders.|12 weeks after the last dose of study drug (up to 24 weeks)|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1307529|NCT02692560|Secondary|Depressive Symptoms|Change in Patient Health Questionnaire (PHQ-8) scale score, from baseline to 12 weeks. The scale range is 0 to 24 with higher scores representing higher depressive symptoms. Scores of 10 or more are considered major depression.|12 weeks|6 Healthy Living participants withdrew before completing the study|||units on a scale||Standard Deviation|Mean
1307530|NCT02692560|Secondary|Total Cholesterol (mg/dL)|Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||mg/dL||Standard Deviation|Mean
1307531|NCT02692560|Secondary|Fasting Glucose (mg/dL)|Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||mg/dL||Standard Deviation|Mean
1307532|NCT02692560|Secondary|Blood Pressure (Systolic Blood Pressure)|Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||mmHg||Standard Deviation|Mean
1307533|NCT02692560|Secondary|Physical Function|Change in Short Physical Performance Battery (SPPB) scale score, from baseline to 12 weeks. The range of scores is 0 to 12, higher values represent better physical function.|12 weeks|6 Healthy Living participants withdrew before completing the study|||units on a scale||Standard Deviation|Mean
1307534|NCT02692560|Secondary|Periods of Sitting for 30+ Minutes|Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||bouts||Standard Deviation|Mean
1307535|NCT02692560|Secondary|Sit-to-stand Transitions|Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||transitions||Standard Deviation|Mean
1307536|NCT02692560|Primary|Change in Hours of Sitting Time|Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later|12 weeks|6 Healthy Living participants withdrew before completing the study|||minutes||Standard Deviation|Mean
1307537|NCT02692495|Secondary|Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor|The measurement of dietary intake of selected nutrients from self-reported food intakes and diet history questionnaires. Correlation of symptoms with added sugar in the diet were noted independently on the source of malodor.|Three years||||grams per day||Standard Deviation|Mean
1307538|NCT02692495|Secondary|Number of Test Results Outside the Normal Range in Different Subgroups of Malodor|Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group|Three years||||Participants|||Count of Participants
1307539|NCT02692495|Secondary|Discriminative Biomarkers in the Subgroups of Malodor|"The investigators have comprehensively analyzed diagnostic ability of tests taken by participants to correlate with their symptoms using several statistical techniques known to bring out strong patterns in a dataset. Principal component analysis (PCA) allowed to clearly separate data into two clusters (Sour and Sweet) shown below along with the Lactic subgroup from the Sour group."|three years||||umol/L||Standard Deviation|Mean
1307540|NCT02692495|Primary|Number of Test Results Outside the Normal Range|The investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.|four years||||participants|||Number
1307541|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin|"Questions were answered seven days after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin while using this product, would you say that you were"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307542|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment – Degree of Sleep|"Questions were answered seven days after treatment by the participant. The question is Thinking about how well you slept when using this product, would you say your sleep was?"|7 days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307543|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin on Waking|"Questions were answered seven days after treatment by the participant. The question is Thinking about your experience when using this product, how would you describe your skin upon awakening?"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307544|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin|"Questions were answered seven days after treatment by the participant. The question is Thinking about your experience while using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307545|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling smooth"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307546|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Slept Better|"Questions were answered seven days after treatment by the participant. The question is I slept better due to less itching or skin discomfort"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307547|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Moisturized All Day|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized all day"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307548|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Soft|"Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel soft"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307549|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets|"Questions were answered seven days after treatment by the participant. The question is This product does not rub off on sheets"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307550|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable|"Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel touchable"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307551|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307552|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Shield for Skin|"Questions were answered seven days after treatment by the participant. The question is This product feels like a shield for my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307553|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture|"Questions were answered seven days after treatment by the participant. The question is This product provides long lasting moisture to my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307554|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin|"Questions were answered seven days after treatment by the participant. The question is I feel comfortable showing my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307555|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking|"Questions were answered seven days after treatment by the participant. The question is I wake up to calmer skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307556|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin|"Questions were answered seven days after treatment by the participant. The question is I'm less distracted by my itchy skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307557|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Calm|"Questions were answered seven days after treatment by the participant. The question is This product calms my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307558|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin|"Questions were answered six hours after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin after using this product, would you say that you were"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307559|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin|"Questions were answered six hours after treatment by the participant. The question is Thinking about your experience after using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307560|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth|"Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling smooth"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1309303|NCT02613871|Secondary|Plasma HBV DNA Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12||Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1307561|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft|"Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel soft"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307562|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable|"Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel touchable"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307563|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized|"Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling moisturized"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307564|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Shield for Skin|"Questions were answered six hours after treatment by the participant. The question is This product feels like a shield for my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307565|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin|"Questions were answered six hours after treatment by the participant. The question is I feel comfortable showing my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307566|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin|"Questions were answered six hours after treatment by the participant. The question is I'm less distracted by my itchy skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307567|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Calms Skin|"Questions were answered six hours after treatment by the participant. The question is This product calms my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307568|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture|"Questions were answered six hours after treatment by the participant. The question is This product provides long lasting moisture"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307569|NCT02691507|Secondary|Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft|"Questions were answered five hours after treatment by the participant. The question is This product leaves my skin feeling soft"|Five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307570|NCT02691507|Secondary|Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture|"Questions were answered five hours after treatment by the participant. The question is This product provides long lasting moisture"|Five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307571|NCT02691507|Secondary|Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft|"Questions were answered four hours after treatment by the participant. The question is This product leaves my skin feeling soft"|Four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307572|NCT02691507|Secondary|Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture|"Questions were answered four hours after treatment by the participant. The question is This product provides long lasting moisture"|Four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307573|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Product Does Not Sting|"Questions were answered immediately after treatment by the participant. The question is This product does not sting when applied"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307574|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Moisturized Skin|"Questions were answered immediately after treatment by the participant. The question is This product leaves my skin feeling immediately moisturized"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307575|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Calm Skin|"Questions were answered immediately after treatment by the participant. The question is This product calms my skin"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307576|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Product Fast Absorbing|"Questions were answered immediately after treatment by the participant. The question is This product is fast absorbing"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307577|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Comfortable Showing Skin Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about how comfortable you felt showing your skin during the last two days, would you say that you were"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307578|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Sleep During Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about how well you slept during the past two days, would you say your sleep was?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307579|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Skin Upon Waking Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, how would you describe your skin upon awakening?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307580|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Distracted by Itchy Eczema Skin Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307581|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Soft Skin|"Questions were answered before treatment by the participant. The question is My skin feels soft"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307582|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Touchable Skin|"Questions were answered before treatment by the participant. The question is My skin feels touchable"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307583|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Moisturized Skin|"Questions were answered before treatment by the participant. The question is My skin feels moisturized"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307584|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Comfortable Showing Skin|"Questions were answered before treatment by the participant. The question is I feel comfortable showing my skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307585|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Smooth Skin|"Questions were answered before treatment by the participant. The question is My skin feels smooth"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307586|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Calmer Skin|"Questions were answered before treatment by the participant. The question is I wake up to calmer skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307587|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment – Distracted by Itchy Skin|"Questions were answered before treatment by the participant. The question is I'm less distracted by my itchy skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1307588|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307589|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307590|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307591|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307592|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to three hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307593|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to two hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307612|NCT02691143|Secondary|Change in Numeric Pain Rating Scale (NPRS)|Subjects rate their pain on the Numeric Pain Rating Scale (NPRS), a scale from 0-10, 0 being none and 10 being the worst imaginable.|3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours||||units on a scale||Full Range|Mean
1307594|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to one hour after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307595|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to Immediately following treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1307596|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 7 Days After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307597|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 6 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307598|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 5 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307599|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 4 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307600|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 3 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to three hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307601|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 2 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to two hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307602|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 1 Hour After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to one hour after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307603|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score Immediately Following Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to immediately following treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1307604|NCT02691416|Secondary|Montreal Cognitive Assessment (MoCA)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery||||units on a scale||Standard Deviation|Mean
1307605|NCT02691416|Secondary|Mini Mental State Examination (MMSE)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery||||units on a scale||Standard Deviation|Mean
1307606|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges|Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery||||number of nucleoplasmic bridges/1000 BN||Standard Deviation|Mean
1307607|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nuclear Buds|Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery||||number of nuclear buds/1000 BN cells||Standard Deviation|Mean
1307608|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography|Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.|before induction,after clamping removal ,operation ending ,1,3,7days post surgery||||ug/ml||Standard Deviation|Mean
1307609|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress:Micronuclei|Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery||||number of micronuclei/1000 BN cells||Standard Deviation|Mean
1307610|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA|Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation|before induction, after clamping removal,operation ending,1,3,7days post surgery||||pg/ml||Standard Deviation|Mean
1307611|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit|Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical|before induction,after clamping removal ,operation ending ,1,3,7days post surgery||||U/ml||Standard Deviation|Mean
1307613|NCT02691143|Primary|Change in Cervical Range of Motion|Six cervical ranges of motion values will be recorded utilizing the Acumar DataCapture hand-held dual inclinometer. Range of motion will be measured at maximum (max) degrees and average degrees of 6 trials and will include: flexion (F), extension (E), left side-bending (LSB), right side-bending (RSB), left rotation (LR), and right rotation (RR).|3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours||||degrees||Full Range|Mean
1307614|NCT02690935|Secondary|Quality of Life During the Whole Period of Observation|This is the mean of the score to 3 daily quality of life questions: 1) Did you sleep well (0 to 3), 2) Are you able to work (0 to 3), 3) How do you feel today (0 to 3). The minimum daily score is 0 (good quality of life) and the maximum is 9 (bad quality of life). The mean of the daily scores was calculated over the whole period of observation (up to 6 months) for each patient.|QoL scores were assessed daily for up to 6 months|ITT population|||units on a scale||Standard Deviation|Mean
1307615|NCT02690935|Primary|Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)|Area under the curve [AUC] (total score of symptoms taking into account the Total 5 Symptom Score (T5SS) and consumption of rescue medications (RM) on the Y-axis versus time on X axis). T5SS was the sum of the 5 individual scores (min-max=0-15). It was corrected each day as a function of consumption of rescue medications (RM): oral antihistamine (+2 points), local treatment (nasal or eye; +1 point), ocular cromoglycate (+1 point) and nasal topical corticosteroids (+1 point). An increase in the total corrected score was considered as a worsening of the allergic symptoms.|Up to Month 6 (end of pollen season)|ITT population|||T5SS score corrected with RM * day||Standard Deviation|Mean
1307616|NCT02690727|Secondary|Pharmacokinetic Parameters|Peak Plasma Concentration (Cmax)|up to 24 hours post-dose.|Subjects who provided evaluable data for both treatments|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1307617|NCT02690727|Secondary|Number of Participants Who Were Evaluated for Adverse Events|Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0|7 days|Healthy volunteers|||Participants|||Count of Participants
1307618|NCT02690727|Primary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.|up to 24 hours post-dose.|subjects who provided evaluable data for both treatments (Fasting and fed conditions)|||nanogram*hour per millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1307619|NCT02690181|Secondary|Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects|Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations (95%CI) in All Subjects at Day 1 Pre-vaccination in the V98_06 study or V98_06E1 for the Naive Group and at Day 61 Post-vaccination in Study V98_06E1.|At Day 1 (V98_06 or V98_06E1) and Day 61||2019-01-31|01/2019||||
1307620|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype III in Subjects With ≥ LLQ|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype III in subjects with ≥ LLQ were estimated for at Day 1, Day 31 and Day 61. The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1, Day 31 and Day 61||2019-01-31|01/2019||||
1307621|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ib in Subjects With ≥ LLQ|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ib in subjects with ≥ LLQ s were estimated for at Day 1, Day 31 and Day 61. The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1, Day 31 and Day 61||2019-01-31|01/2019||||
1307622|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With ≥ LLQ|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with ≥ LLQ were estimated for at Day 1, Day 31 and Day 61.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
1307623|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype III in Subjects With < LLQ|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype III in subjects with < LLQ were estimated for at Day 1, Day 31 and Day 61. The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1, Day 31 and Day 61||2019-01-31|01/2019||||
1307624|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ib in Subjects With < LLQ|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ib in subjects with < LLQ were estimated for at Day 1, Day 31 and Day 61. The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1, Day 31 and Day 61||2019-01-31|01/2019||||
1307625|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With < LLQ|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in with subjects < LLQ were estimated for at Day 1, Day 31 and Day 61.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
1307626|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype III|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype III in All Subjects were estimated for at Day 1, Day 31 and Day 61. The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1, Day 31 and Day 61||2019-01-31|01/2019||||
1307627|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ib|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ib in All Subjects were estimated for at Day 1, Day 31 and Day 61. The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1, Day 31 and Day 61||2019-01-31|01/2019||||
1308803|NCT02634580|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1307628|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in All Subjects were estimated for at Day 1, Day 31 and Day 61.|At Day 1, Day 31 and Day 61.|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
1307629|NCT02690181|Secondary|Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 31 post-vaccination, as measured by ELISA. The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 31||2019-01-31|01/2019||||
1307630|NCT02690181|Secondary|Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 31 post-vaccination, as measured by ELISA. The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 31||2019-01-31|01/2019||||
1307631|NCT02690181|Secondary|Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 31 post-vaccination, as measured by ELISA.|At Day 31|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||Percentage of subjects||95% Confidence Interval|Number
1307632|NCT02690181|Primary|Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal|"An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.~Medically attended adverse event” is defined as an adverse event that leads to a visit to a healthcare provider and “AEs leading to withdrawal” are defined as adverse events leading to study or vaccine withdrawal."|Day 1 to Day 181|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.|||Participants|||Count of Participants
1307633|NCT02690181|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|The number of subjects with any unsolicited AEs from the day of vaccination in study V98_06E1 to Day 31. An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified.|Day 1 to Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.|||Participants|||Count of Participants
1307634|NCT02690181|Primary|Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)|Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm).|Day 1 to Day 7|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any solicited adverse event data and/or indicators of solicited adverse events (e.g., use of analgesics/antipyretics).|||Participants|||Count of Participants
1307635|NCT02690181|Primary|Percentage of All Subjects With ELISA Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination, as measured by ELISA. The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 61||2019-01-31|01/2019||||
1307636|NCT02690181|Primary|Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination, as measured by ELISA. The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 61||2019-01-31|01/2019||||
1307637|NCT02690181|Primary|Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).|At Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||Percentage of subjects||95% Confidence Interval|Number
1307690|NCT02689206|Secondary|Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on EPO. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at each given post-Baseline time point was calculated and the maximum change from Baseline was determined.|Baseline and up to Day 29|ITT Population|||International unit per liter (IU/L)||Standard Deviation|Mean
1307638|NCT02689973|Secondary|Physical Activity Self-efficacy (PA Self-efficacy)|"Physical activity self-efficacy (T1 and T2) was measured with 9 items (e.g., ‘I am able to maintain regular MVPA even if I would have to reorganize my daily life’; Luszczynska et al., 2011).~Number of Items: 9~Response format: Responses ranged from 1 (‘definitely not’) to 4 (‘exactly true’).~Scoring: the total score of 9 items~Scoring formula: the sum score for the 9 items divided by 9, i.e. {item #1 + item #2 + item #3 + item #4+ item #5 + item #6 + item #7 + item #8 + item #9} : 9~Interpretation: Higher scores indicate better results (the higher levels of PA self-efficacy)"|Baseline to 2-month follow-up||||units on a scale||Standard Deviation|Mean
1307639|NCT02689973|Secondary|The Use of Physical Activity Planning (the Use of Planning)|"Use of physical activity planning was measured with four items (e.g., ‘I have my own plan regarding when to engage in exercise of moderate-to-vigorous intensity’; Schwarzer et al., 2008).~Number of Items: 4~Response format: Responses ranged from 1 (‘definitely not’) to 4 (‘exactly true’).~Scoring: the total score of 4 items~Scoring formula: the sum score for the 4 items divided by 4, i.e. {item #1 + item #2 + item #3 + item #4} : 4~Interpretation: Higher scores indicate better results (the more frequent use of planning)"|Baseline to 2-month follow-up||||units on a scale||Standard Deviation|Mean
1307640|NCT02689973|Secondary|Moderate-to-vigorous Physical Activity (MVPA)|"Items from Godin and Shephard’s (1985) Leisure-Time Exercise Questionnaire (e.g., ‘Considering a 7-day period [a week], how many times on the average do you do the following kinds of exercise for more than 15 minutes during your free time: strenuous exercise [heart beats rapidly], i.e. running, jogging, hockey, soccer, basketball, cross-country skiing, vigorous swimming, vigorous long distance bicycling’).~Number of Items: 2~Response format: open ended, the participant indicated the number of 15 min blocks of physical activity (actual range obtained in the study: minimum = 0, maximum = 42, )~Scoring: the total score of 2 items~Scoring formula: the sum score for the number of minutes of MVPA per week, i.e. individual score = {response to item #1 x 15} + {response to item # 2 x 15})~Interpretation: Higher scores indicate better results (more minutes of MVPA per week)"|Baseline to 14-month follow-up||||units on a scale||Standard Deviation|Mean
1307641|NCT02689973|Primary|Body Fat Tissue|bioimpedance (BIA) method (Kyle et al., 2004), which determines the electrical impedance of an electric current through body tissues. Fat tissue was estimated with Schaefer equation for BIA which is considered a reliable index of body fat in adolescent from primarily white backgrounds (Cleary et al., 2008).|Baseline to 14-month follow-up||||percentage of body fat||Standard Deviation|Mean
1307642|NCT02689804|Secondary|Time to Maximum Concentration of Serum UPA|(Tmax) calculated in women with normal and obese BMI|Up to 24 hours||||h||Standard Deviation|Mean
1307643|NCT02689804|Secondary|Time to Maximum Concentration of Serum LNG|(Tmax) calculated in women with normal and obese BMI|Up to 24 hours||||h||Standard Deviation|Mean
1307644|NCT02689804|Secondary|Maximum Concentration of Serum UPA|(Cmax) calculated in women with normal and obese BMI|Up to 24 hours||||ng/mL||Inter-Quartile Range|Mean
1307645|NCT02689804|Secondary|Maximum Concentration of Serum LNG|(Cmax) calculated in women with normal and obese BMI|Up to 24 hours||||ng/mL||Inter-Quartile Range|Mean
1307646|NCT02689804|Secondary|Clearance of Serum UPA|(Cl) calculated in women with normal and obese BMI|Up to 24 hours||||L/h||Inter-Quartile Range|Mean
1307647|NCT02689804|Secondary|Clearance of Serum LNG|(Cl) calculated in women with normal and obese BMI|Up to 24 hours||||L/h||Inter-Quartile Range|Mean
1307648|NCT02689804|Secondary|Elimination Half-life of Serum UPA|(t1/2) calculated in women with normal and obese BMI|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||h||Inter-Quartile Range|Mean
1307649|NCT02689804|Secondary|Elimination Half-life of Serum LNG|(t1/2) calculated in women with normal and obese BMI|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||h||Inter-Quartile Range|Mean
1307650|NCT02689804|Primary|Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration|UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||ng*h/mL||Inter-Quartile Range|Mean
1307651|NCT02689804|Primary|Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration|LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||ng*h/mL||Inter-Quartile Range|Mean
1307652|NCT02689206|Secondary|Change From Baseline in Weight at Post-dialysis|Vital sign measurements including weight were taken in a seated or semi-supine position in the dialysis chair. Weight was measured post-dialysis. Post-dialysis Baseline value was defined as SBP and DBP value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||kg||Standard Deviation|Mean
1307653|NCT02689206|Secondary|Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis|Vital sign measurements including pulse rate were taken in a seated or semi-supine position in the dialysis chair. Pulse rate was measured pre-dialysis and post-dialysis. Pre-dialysis Baseline value was defined as pulse rate value obtained pre-dialysis on Day 1. Post-dialysis Baseline value was defined as pulse rate value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Beats per minute||Standard Deviation|Mean
1307808|NCT02681510|Secondary|Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking|Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction)|Week 12|All study participants (N=36)|||units on a scale||Standard Deviation|Mean
1307654|NCT02689206|Secondary|Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis|Vital sign measurements including SBP and DBP were taken in a seated or semi-supine position in the dialysis chair. SBP and DBP were measured pre-dialysis and post-dialysis. Pre-dialysis Baseline value was defined as SBP and DBP value obtained pre-dialysis on Day 1. Post-dialysis Baseline value was defined as SBP and DBP value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||mmHg||Standard Deviation|Mean
1307655|NCT02689206|Secondary|Weight Values at Post-dialysis|Vital sign measurements including weight values were taken in a seated or semi-supine position in the dialysis chair. Weight was measured post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Kilograms (kg)||Standard Deviation|Mean
1307656|NCT02689206|Secondary|Pulse Rate Values at Pre-dialysis and Post-dialysis|Vital sign measurements including pulse rate values were taken in a seated or semi-supine position in the dialysis chair. Pulse rate was measured pre-dialysis and post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Beats per minute||Standard Deviation|Mean
1307657|NCT02689206|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis|Vital sign measurements including SBP and DBP were taken in a seated or semi-supine position in the dialysis chair at specific time points. SBP and DBP were measured pre-dialysis and post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1307658|NCT02689206|Secondary|Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval and QTcB|Single measurements of 12-lead ECG were obtained in supine position using an ECG machine to measure PR interval, QRS duration, QT interval and QTcB. Week -4 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values at Day 29 minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Day 29|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Milliseconds (msec)||Standard Deviation|Mean
1307659|NCT02689206|Secondary|Change From Baseline in ECG Mean Heart Rate|Single measurements of 12-lead ECG were obtained in supine position using an ECG machine to measure HR. Week -4 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values at Day 29 minus Baseline value.|Baseline and Day 29|Safety Population|||Beats per minute||Standard Deviation|Mean
1307660|NCT02689206|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Indicated Time Points|Single measurements of 12-lead ECG were obtained in supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT interval. Number of participants who had abnormal non clinically significant (NCS) and abnormal clinically significant (CS) ECG findings at Baseline (Week -4) and Day 29 are presented.|Up to Day 29|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Participants|||Number
1307661|NCT02689206|Secondary|Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including leukocytes, neutrophils, basophils, eosinophils, lymphocytes, monocytes, platelets. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||10^12 cells/L||Standard Deviation|Mean
1307662|NCT02689206|Secondary|Change From Baseline in Erythrocyte Distribution Width Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte distribution width. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Percentage of width||Standard Deviation|Mean
1307809|NCT02681510|Secondary|Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms|Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction)|Week 12||||units on a scale||Standard Deviation|Mean
1307663|NCT02689206|Secondary|Change From Baseline in MCV Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||fL||Standard Deviation|Mean
1307664|NCT02689206|Secondary|Change From Baseline in MCHC Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||g/L||Standard Deviation|Mean
1307665|NCT02689206|Secondary|Change From Baseline in MCH Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Pg||Standard Deviation|Mean
1307666|NCT02689206|Secondary|Erythrocyte Distribution Width Levels in Blood at Indicated Time Points|Erythrocyte distribution width levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Percentage of width||Standard Deviation|Mean
1307667|NCT02689206|Secondary|Mean Corpuscular Volume (MCV) Levels in Blood at Indicated Time Points|Serum MCV levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Femtoliter (fL)||Standard Deviation|Mean
1307668|NCT02689206|Secondary|Mean Corpuscular Hemoglobin Concentration (MCHC) Levels in Blood at Indicated Time Points|Serum MCHC levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||g/L||Standard Deviation|Mean
1307669|NCT02689206|Secondary|Mean Corpuscular Hemoglobin (MCH) Levels in Blood at Indicated Time Points|Serum MCH levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Pg||Standard Deviation|Mean
1307670|NCT02689206|Secondary|Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points|Serum leukocytes, neutrophils, basophils, eosinophils, lymphocytes, monocytes and platelet levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||10^12 cells/L||Standard Deviation|Mean
1307671|NCT02689206|Secondary|Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including bilirubin, direct bilirubin and indirect bilirubin. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the Daprodustat 25mg treatment group for all PK population and safety population analyses.|||µmol/L||Standard Deviation|Mean
1311876|NCT02530281|Primary|Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4||From Baseline to Week 4|Participant|||mg/5 min||Standard Deviation|Least Squares Mean
1307672|NCT02689206|Secondary|Change From Baseline in ALT, AST, Alk. Phosph. Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT, AST, Alk. phosph. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||IU/L||Standard Deviation|Mean
1307673|NCT02689206|Secondary|Change From Baseline in Albumin and Protein Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||g/L||Standard Deviation|Mean
1307674|NCT02689206|Secondary|Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including sodium, potassium, glucose, calcium and phosphate. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Mmol/L||Standard Deviation|Mean
1307675|NCT02689206|Secondary|Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points|Serum bilirubin, direct bilirubin and indirect bilirubin levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1307676|NCT02689206|Secondary|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points|Serum ALT, AST and alk. phosph. levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||IU/L||Standard Deviation|Mean
1307677|NCT02689206|Secondary|Albumin and Protein Levels in Blood at Indicated Tme Points|Serum albumin and protein levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||grams per liter (g/L)||Standard Deviation|Mean
1307678|NCT02689206|Secondary|Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points|Serum sodium, potassium, glucose, corrected calcium and phosphate levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1307679|NCT02689206|Secondary|Number of Participants With AEs and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Participants|||Number
1307691|NCT02689206|Primary|Change From Baseline in Hgb Levels at Day 29|Blood samples were collected from participants for measurement of Hgb values. Baseline is the average of Hgb measured at Week -2 and Day 1 visits. Change from Baseline at Day 29 was defined as post dose value at Day 29 minus Baseline value. The analysis was performed on intent-to-treat (ITT) Population which comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one corresponding on treatment assessment, including Hgb.|Baseline and Day 29|ITT Population|||g/dL||Standard Deviation|Mean
1307680|NCT02689206|Secondary|Number of Participants Who Discontinued Study Treatment|Reasons of study treatment discontinuation included adverse events (AEs), protocol deviation, participants reached protocol defined stopping criteria, physician decision and withdrawal by participants. Number of participants who discontinued study treatment are presented. Analysis was performed on Safety Population which comprised of all participants who received at least one dose of study treatment.|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Participants|||Number
1307681|NCT02689206|Secondary|Time to Reach Cmax (Tmax) and Apparent Terminal Half-life (t1/2) of Dapro|Blood samples were collected at indicated time points for PK analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a “Day 1” profile for NCA. Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29|PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Hour||Geometric Coefficient of Variation|Geometric Mean
1307682|NCT02689206|Secondary|Maximum Observed Concentration of Dapro in Plasma (Cmax)|Blood samples were collected at indicated time points for PK analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a “Day 1” profile for NCA. Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated.|Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307683|NCT02689206|Secondary|Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) and AUC From Time Zero to Infinity (AUC[0-inf]) of Dapro|Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a “Day 1” profile for non-compartmental analysis (NCA). Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated. The analysis was performed on PK Population, which comprised of all participants from whom a PK sample has been obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29|PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||hour into nanograms/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1307684|NCT02689206|Secondary|Change From Baseline in Reticulocyte Hemoglobin (CHr)|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on CHr. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||Picograms (pg)||Standard Deviation|Mean
1307685|NCT02689206|Secondary|Change From Baseline in Reticulocyte Count|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on reticulocyte count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||Percentage of reticulocyte||Standard Deviation|Mean
1307686|NCT02689206|Secondary|Change From Baseline in Red Blood Cell (RBC) Count|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on RBC count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||10^12 cells/L||Standard Deviation|Mean
1307687|NCT02689206|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on hematocrit. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
1307688|NCT02689206|Secondary|Percent Change From Baseline in Hepcidin at Day 29|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on hepcidin. Day 1 values were considered as Baseline values. The Percent change from Baseline at Day 29 post-Baseline time point was calculated and expressed as geometric mean and the maximum change from Baseline was determined.|Baseline and Day 29|ITT Population|||Micrograms per liter (µg/L)||95% Confidence Interval|Geometric Mean
1307689|NCT02689206|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on VEGF. Day 1 values were considered as Baseline values. The percent change from Baseline at each given post-Baseline time point was calculated (expressed as geometric mean) and the maximum percent change from Baseline was determined.|Baseline and up to Day 29|ITT Population|||Nanograms per liter (ng/L)||95% Confidence Interval|Geometric Mean
1307692|NCT02688933|Post-Hoc|Change From Baseline in Time (Min) of Mean Glucose Concentration Within the Target Range of 70 to 180 mg/dL, by End of Study hbA1c Levels During Week 15 and/or Week 16|Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessments. Data was reported for participants with an end of study HbA1c <7.5 or HbA1c >=7.5% over a 24 hour period.|Baseline, during Week 15 and/or Week 16|mITT population. Here, “number analyzed” signifies the number of participants evaluable for each specified category.|||minutes||Standard Error|Least Squares Mean
1307693|NCT02688933|Other Pre-specified|Change From Baseline in Daily Insulin Dose at Week 16|Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported.|Baseline, Week 16|Safety population: all participants who took at least 1 dose of randomized treatment & analyzed as-treated (as per treatment actually received) also to whom it was unclear whether they took study medication & who received more than 1 study treatment during trial. Here, “number analyzed”: number of participants evaluable for each specified category.|||International Units||Standard Deviation|Mean
1307694|NCT02688933|Secondary|Coefficient of Variation (CV%) in Mean CGM Glucose|CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.|During Week 15 and/or Week 16|mITT population.|||percent of mean glucose level||Standard Error|Least Squares Mean
1307695|NCT02688933|Secondary|Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection|Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day’s basal insulin injection during Week 15 (and/or Week 16).|During Week 15 and/or Week 16|mITT population|||percentage of time||Standard Error|Least Squares Mean
1307696|NCT02688933|Secondary|Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16|Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day’s basal insulin injection during Week 15 (and/or Week 16).|Baseline, during Week 15 and/or Week 16|mITT population.|||mg/dL||Standard Error|Least Squares Mean
1307697|NCT02688933|Secondary|Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year|Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.|Baseline up to Week 16|mITT population.|||events per participant-year|||Number
1307698|NCT02688933|Secondary|Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia|Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).|Baseline up to Week 16|mITT population.|||percentage of participants|||Number
1307699|NCT02688933|Primary|Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM|The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).|During Week 15 and/or 16|Modified intent-to-treat (mITT) population that included all participants who were randomized and had a post-baseline CGM assessment and enough CGM data values to calculate the primary outcome measure, percent of time in range of 70-180 mg/dL during Week 15 (and/or Week 16).|||percentage of time||Standard Error|Least Squares Mean
1307700|NCT02688153|Secondary|Health Care Utilization|The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.|Day of surgical procedure through discharge from the hospital, an average of 2 weeks|This outcome is reported for subjects where data is available.|||Days||Standard Deviation|Mean
1307701|NCT02688153|Secondary|Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years.|Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported where data is available.|||Units on a scale||Standard Deviation|Mean
1307702|NCT02688153|Secondary|Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time|"The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS).~The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.~Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12."|Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported where data is available.|||Units on a scale||Standard Deviation|Mean
1307703|NCT02688153|Secondary|Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time|The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported where data is available.|||Units on a scale||Standard Deviation|Mean
1307704|NCT02688153|Secondary|Subjects Who Died Intraoperatively|Number of subjects who died during surgery.|Surgery|Number of subjects who died during surgery|||Participants|||Count of Participants
1307705|NCT02688153|Secondary|Subjects With a Cardiac Reoperation for Any Reason Over Time|Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1311877|NCT02530281|Primary|Proportion of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4||From Baseline to Week 4|Participant|||% of subjects|||Number
1307706|NCT02688153|Secondary|Subjects With a Cardiac Tamponade Over Time|Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307707|NCT02688153|Secondary|Subjects With a Thromboembolism Over Time|Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307708|NCT02688153|Secondary|Subjects With a Myocardial Infarction Over Time|Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307709|NCT02688153|Secondary|Subjects With a Deep Sternal Would Infection Over Time|Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307710|NCT02688153|Secondary|Subjects With Endocarditis Over Time|Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307711|NCT02688153|Secondary|Subjects With Renal Failure Over Time|Number of subjects who experienced Renal (kidney) Failure shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307712|NCT02688153|Secondary|Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time|Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307713|NCT02688153|Secondary|Subjects Who Experienced Respiratory Failure Over Time|Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.|30 days, 3 Months , 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307714|NCT02688153|Secondary|Subjects Who Experienced Major Bleeding Over Time.|Number of subjects who experienced Major Bleeding shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307715|NCT02688153|Secondary|Subjects With a Major Paravalvular Leak (OPC) Over Time|"Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points.~Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.~Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event."|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307716|NCT02688153|Secondary|Subjects Who Received a Permanent Pacemaker Over Time.|Number of Subjects who received a Permanent Pacemaker shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307717|NCT02688153|Secondary|Subjects Who Required a Thoracic Resternotomy Over Time|Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
1307718|NCT02688153|Secondary|Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.|Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.|Prior to Surgery|Original number of subjects randomized to each arm/group.|||Participants|||Count of Participants
1307719|NCT02688153|Secondary|Amount of Aortic Valvular Regurgitation Over Time.|Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||Participants|||Count of Participants
1307720|NCT02688153|Secondary|Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person’s body surface area. Effective orifice area index is evaluated by echocardiography over time.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||centimeters squared/meters squared||Standard Deviation|Mean
1307721|NCT02688153|Secondary|Subject's Effective Orifice Area (EOA) Measurement Over Time.|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||centimeters squared||Standard Deviation|Mean
1307722|NCT02688153|Secondary|Subject's Average Peak Gradients (mmHg) Measurements Over Time.|Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||mmHg||Standard Deviation|Mean
1307723|NCT02688153|Secondary|Subject's Average Mean Gradients (mmHg) Measurements Over Time.|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported for subjects where data is available.|||mmHg||Standard Deviation|Mean
1307724|NCT02688153|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.~Symptoms of heart failure or the anginal syndrome may be present even at rest."|Baseline and 2 Years|The outcome is reported for subjects where data is available.|||Participants|||Count of Participants
1307725|NCT02688153|Primary|Average Amount of Time Subject Spent on Cardiopulmonary Bypass|Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.|At time of surgery, an average of 2 hours|The outcome is reported for subjects where data is available.|||Minutes||Full Range|Median
1307726|NCT02688153|Primary|Average Subject Time Spent on Cardiopulmonary Cross Clamp|Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.|At time of surgery, an average of 1.5 hours|The outcome is reported for subjects where data is available.|||Minutes||Full Range|Median
1307727|NCT02687217|Secondary|Number of Patients Requiring Additional Treatment|Requirement of antipyretics; increased dose/ duration of antibiotic usage other than standard protocol; need for change to higher antibiotics; requirement of drainage procedures for pus/ wound infections; requirement for additional dressing sessions|14 days||||participants|||Number
1307728|NCT02687217|Secondary|Number of Patients Requiring Additional Investigations|Sonography; Pus culture; blood culture; Total Leucocyte Count.|14 days||||participants|||Number
1307729|NCT02687217|Primary|ASEPSIS Score|"ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection.~Category of infection:~Total score of 0–10 satisfactory healing; 11–20 disturbance of healing; 21–30 minor wound infection; 31–40 moderate wound infection; > 40 severe wound infection."|14 days||||participants|||Number
1307730|NCT02687126|Other Pre-specified|Cross Sectional Area of Internal Jugular Vein|Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate|up to 1 hour before intervention||||Pearson's correlation Coefficient|||Number
1307731|NCT02687126|Secondary|Number of Patients With Complications|Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma|up to 24 hours after intervention||||Participants|||Count of Participants
1307732|NCT02687126|Secondary|Time to Successful Cannulation|Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal|up to 1 hour after intervention||||Seconds||Standard Deviation|Mean
1307733|NCT02687126|Primary|Number of Attempts for Successful Central Venous Cannulation|An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur|up to 24 hours after intervention||||Attempts||Standard Deviation|Mean
1307734|NCT02686437|Primary|Penn Shoulder Score (PENN)|The PENN is a outcome measure designed to determine the amount of disability patients are experiencing doing day to day activities. The total score is out of 100, 100 being no disability and 0 being completely disabled.|4 weeks||||units on a scale||Standard Error|Mean
1307735|NCT02686437|Primary|Numeric Pain Rating Scale (NPRS)|Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain|4 weeks||||units on a scale||Standard Error|Mean
1307736|NCT02685488|Post-Hoc|State Anxiety Assessed With Two Items From the Visual Analogue Mood Scale|The Visual Analog Mood Scale (VAMS) asks patients to rate how much they are experiencing eight mood categories on a scale of 0-100. Global Affect and Global Vigor are subscales. The Global Vigor scale includes a number of items related to anxiety (calm, tense) as well as fatigue (alert, weary). Based on decreases that were seen in global vigor, we create a sum variable of only calm & tense items on the VAMS to examine whether state anxiety decreased. Scores range from 0-20, with higher scores indicating more anxiety. This sum variable served as a post-hoc measures of anxiety each day of the study before stimulation/sham, 10 minutes after stimulation/sham, and 30 minutes after stimulation/sham. Outcome is the difference between measure taken 10 minutes after Stim/Sham and measure taken before Stim/Sham. This measure was taken each of the five days and outcome represents the average over all five days from after to before Stim/Sham.|Assessed before Stim/Sham and 10 minutes after every day for five days; scores represent change from after to before stim/sham averaged across all five days||||units on a scale||Standard Deviation|Mean
1307737|NCT02685488|Secondary|Anxiety Symptoms Assessed With the Overall Anxiety Severity and Impairment Scale|The Overall Anxiety Severity and Impairment Scale (OASIS) assesses severity of anxiety symptoms across anxiety disorders and with subsyndromal symptoms. Participants rate five items on a scale from 0 (indicating no anxiety or impairment) to 4 (indicating severe or extreme anxiety or impairment). Scores range from 0 to 20, with higher scores indicating more severe anxiety and impairment from anxiety (Norman et al., 2006). The OASIS was used to monitor overall severity of anxiety on each day of the study. The outcome measure is difference from Day 5 to Day 1.|Once on day 1 & day 5||||units on a scale||Standard Deviation|Mean
1307777|NCT02683746|Secondary|Number of Participants With Positive Result for Anti-albiglutide Antibody|Blood samples were obtained from participants at specific time points before administration of study treatment. The presence of anti-albiglutide antibodies was assessed using a validated enzyme linked immunosorbent assay (ELISA). The assay involves screening, confirmation, and titration steps (tiered-testing approach). Number of participants with positive anti- albiglutide antibody results at 'any visit post-Baseline' are presented.|Up to Week 34|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
1307738|NCT02685488|Secondary|Worry Symptoms Assessed With the Penn State Worry Questionnaire|"The PSWQ assesses trait worry, a key component of Generalized Anxiety Disorder. Participants rate themselves on a scale of 1 (not at all typical of me) to 5 (very typical of me) for sixteen different statements. Scores range from 16-80, and higher scores reflect higher levels of worry. This scale has been widely used to assess worry and will allow for assessment of worry in the present study (Brown et al., 1992). The PSWQ was used to monitor symptoms of worry on first and fifth day of this study. The outcome measure is difference from Day 5 to Day 1."|Once on day 1 & day 5||||units on a scale||Standard Deviation|Mean
1307739|NCT02685488|Secondary|Rumination Symptoms Assessed With the Ruminative Responses Scale|"The Ruminative Responses scale (RRS) consists of 22 statements. It measures rumination, past-focused repetitive thinking that causes and maintains depression. Participants are asked to rate on a scale of 1 (almost never) to 4 (almost always) how much they think about various things (e.g. think about how alone you feel and think about all your shortcomings, failings, faults, mistakes). Scores range from 22 to 88 with higher scores indicating more rumination. The RRS was used in this study to measure symptoms of rumination on the first and fifth day of this study. The outcome is the difference from Day 5 to Day 1."|Once on day 1 & 5||||units on a scale||Standard Deviation|Mean
1307740|NCT02685488|Primary|Depressive Symptoms Assessed With the Beck Depression Inventory-II|The Beck Depression Inventory-II (BDI-II) is one of the most widely used self-report measures for assessing depression. It includes 21 self-report items. Scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms. In this study, the BDI-II was used to monitor depressive symptoms each day. The outcome is the change in BDI-II score as measured by BDI-II on Day 5 minus BDI-II on Day 1.|Once on day 1 & day 5||||units on a scale||Standard Deviation|Mean
1307741|NCT02685202|Secondary|Change in the Epworth Sleepiness Scale (ESS) Score|Daytime sleepiness will be assessed using the ESS which is based on responses to self-administered questions that assess the propensity of the subject to fall asleep in 8 everyday situations (e.g., sitting and reading, talking to someone, being stopped in traffic). Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness.|Baseline, 16 weeks|No participants could be reached to obtain ESS scores; therefore, data for this outcome measure are unavailable.||||||
1307742|NCT02685202|Secondary|Change in the Apnea Hypopnea Index (AHI)|The AHI is the sum of the number of apneas and hypopneas recorded during the home sleep test per hour of recorded sleep. The AHI is used to indicate the severity of obstructive sleep apnea.|Baseline, 16 weeks|No participants could be reached to obtain apnea and hypopneas sums; therefore, data for this outcome measure are unavailable.||||||
1307743|NCT02685202|Primary|Change in the Weekly Mean Pain Index Score|"Weekly mean pain index is computed as the arithmetic mean of daily pain index values recorded at enrollment and then at the end of each week throughout the 16 week observation period.~Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = no pain and 100 = the most intense pain imaginable) multiplied by pain duration (0-100 percentage scale) where percentage refers to the percent of waking day that the participant had facial pain) as reported in the Daily Symptom Diary.~It is computed from the weekly mean pain index (numeric rating scale 0-10), and representing the arithmetic mean of daily pain index values in the preceding 7-day period. The pain index for any given day is the product of the pain intensity score multiplied by the pain duration score, each as reported in the Daily Symptom Diary kept by the subject."|Baseline, 16 weeks|No participants could be reached to obtain pain symptom diary information; therefore, data for this outcome measure are unavailable.||||||
1307744|NCT02684942|Other Pre-specified|Fentanyl Dose|Sum of fentanyl dose when finish each fraction of brachytherapy|after complete treatment.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.|||ug.|fraction|Standard Deviation|Mean
1307745|NCT02684942|Other Pre-specified|Meperidine Dose|Sum of meperidine dose when finish each fraction of brachytherapy|after complete treatment.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.|||mg.|fraction|Standard Deviation|Mean
1307746|NCT02684942|Other Pre-specified|Tumor Size|Size of tumor at cervix measured by the doctor before insert applicator.|Before insert applicator in each fraction of brachytherapy.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.|||CM.|fraction|Standard Deviation|Mean
1307747|NCT02684942|Other Pre-specified|Ovoids Size|Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.|after complete applicator insertion.|Each patient was treated with 4 fractions of brachytherapy.|||Centimeter|fraction|Full Range|Median
1307748|NCT02684942|Secondary|Quality of Life|Perceived Quality of life (EQ-5D) was assessed before the first brachytherpy and immediately after completion of each of the 4 brachytherapy fractions. The EQ-5D have 5 dimensions: mobility, self-care, usual activities, topics each content 3 responses: no problems, some problems, extreme problems.|From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks|Pain score in each fraction.|||participants|fraction||Number
1307749|NCT02684942|Primary|Pain Score|Perceived pain score according to standard 10-cm visual analog scales (VAS) was assessed before injection of medicine for every 15 minutes up to 120 minutes.The minimum and maximum scores were 0, 10. Score 0 means no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain and 10 worst pain.|From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks||||units on a scale|fraction|Standard Deviation|Mean
1307750|NCT02684630|Primary|Donor Postprocedure Platelet Count Following Donation of Double Platelet Product|The primary endpoint for this study was the participant’s postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant’s postprocedure platelet count was ≥ 100,000 platelets/μL.|The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
1307810|NCT02681510|Primary|Number of Participants With Adverse Events|Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period|12 weeks|All study participants (N=36)|||Participants|||Count of Participants
1307751|NCT02684630|Primary|Donor Postprocedure Platelet Count Following Donation of Single Platelet Product|The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant’s postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant’s postprocedure platelet count was < 100,000 platelets/μL.|The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
1307752|NCT02684604|Primary|Quantitative Helicobacter Pylori IgG Assay in Serum|calculation of quantitative Helicobacter pylori IgG assay in serum|24 hours||||arbitrary unit per millilitre||Inter-Quartile Range|Median
1307753|NCT02684396|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1307754|NCT02684396|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1307755|NCT02684396|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||hours||Full Range|Median
1307756|NCT02684396|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
1307757|NCT02684396|Primary|Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.|||percentage of participants|||Number
1307758|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose|Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.|||percentage of participants|||Number
1307759|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.|||percentage of participants|||Number
1307760|NCT02684396|Primary|Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1307761|NCT02684188|Primary|Primary Care Provider (PCP) Visits Analyzed by Logistic Regression|This reflects the proportion of patients who reported at least one visit to a their local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to a regional referral hospital for treatment, who enrolled in the study and were discharged to one of four rural counties.|||Proportion with Primary Care Visits|||Number
1307762|NCT02684188|Secondary|Rural Transition Measure (RTM14)|The RTM14 is a fourteen-item questionnaire to measures patients’ perspectives on the delivery of transition services and supports after discharge from a regional hospital to a small town or rural community. Patients respond by indicating whether they strongly disagree, disagree, agree, or strongly agree with each of the 14 items. Patients may also indicate whether an item is not applicable to their situation. Ratings are converted to a scale that ranges from 0 to 100. Higher scores reflect better transition service performance.|7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Survey Response Scores||Standard Deviation|Mean
1307763|NCT02684188|Secondary|Care Transition Measure (CTM3)|The CTM3 is a three-item standardized questionnaire to measures patients’ perspectives on coordination of hospital discharge care. Patients rate whether they strongly agree, agree, disagree, or strongly disagree with three items (hospital staff too my preferences into account, I had a good idea what I was responsible for once I left the hospital, and I clearly understood the purpose for taking each of my medications). They may also rate an items as not applicable to their situation. Ratings are converted to a scale that ranges from 0 to 100. Higher scores reflect better discharge care.|3 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Survey Response Scores||Standard Deviation|Mean
1307764|NCT02684188|Secondary|Short Form (SF12) Mental Health Score|The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health. Patients rate each item on an ordinal scale. Data are analyzed using a proprietary algorithm. Scores range from 0 to 100. Higher scores reflect a better health status. The analysis creates an overall health score and sub scores that reflect physical health and mental health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||units on a scale||Standard Deviation|Mean
1307811|NCT02681458|Primary|The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users||up to two months||||participants|||Number
1307765|NCT02684188|Secondary|Short Form (SF12) Physical Health Score|The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health. Patients rate each item on an ordinal scale. Data are analyzed using a proprietary algorithm. Scores range from 0 to 100. Higher scores reflect a better health status. The analysis creates an overall health score and sub scores that reflect physical health and mental health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||units on a scale||Standard Deviation|Mean
1307766|NCT02684188|Primary|Primary Care Provider (PCP) Visits Analyzed by Poisson Regression|This reflects the number of visits to a patient's local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to a regional referral hospital for treatment, who enrolled in the study and were discharged to one of four rural counties.|||Primary Care Provider Visits|||Number
1307767|NCT02684188|Primary|Emergency Department (D) Visits Analyzed by Logistic Regression|Proportion of patients who report at least one emergency department visit after discharge from a regional hospital to one of four rural counties.|3, 7, 14, 21,30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||participants with at least one ED visit|||Number
1307768|NCT02684188|Primary|Emergency Department (ED) Visits Analyzed by Poisson Regression|Number of self-reported visits to the emergency department of any hospital reported by patients after discharge from a regional hospital to one of four rural counties.|3, 7, 14, 21,30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Emergency Department Visits|||Number
1307769|NCT02684188|Primary|Hospital Re-admissions Analyzed by Logistic Regression|Proportion of patients who self-report at least one hospital readmission to any hospital after discharge from a regional hospital to one of four rural counties.|3, 7 ,14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||proportion of patients rehospitalized|||Number
1307770|NCT02684188|Primary|Hospital Re-admissions Analyzed by Poisson Regression|Number of admissions to any hospital reported by the patients after discharge from a regional hospital to one of four rural counties.|3, 7 ,14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Hospital Readmission|||Number
1307771|NCT02683954|Primary|Serum Nesfatin 1|"Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay ELISA technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals."|24 hours|In the endometriosis group, two patients were stage I, one was stage II, 12 were stage III and 15 were stage IV according to the revised ASRM scoring system. In the control group, 13 had polycystic varies, 11 had variable pelvic peritoneal adhesions, 4 had tubal block , one had unilateral ovarian cyst and one patient had atrophic ovaries.|||picogram/millilitre||Inter-Quartile Range|Median
1307772|NCT02683746|Secondary|Trough Plasma Concentration of Albiglutide Over Time|Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of albiglutide. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose at Week 12 and Week 26|PK Population|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1307773|NCT02683746|Secondary|Change From Baseline in FPG Over Time|Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 26|ITT Population|||Mmol/L||Standard Error|Least Squares Mean
1307774|NCT02683746|Secondary|Change From Baseline in HbA1c Over Time|Blood samples were collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model and model-adjusted least square mean (LS mean) and standard error have been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 26|ITT Population|||Percent of total hemoglobin||Standard Error|Least Squares Mean
1307775|NCT02683746|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model.|Baseline and Week 26|ITT Population. Only those participants available at Week 26 were analyzed.|||Mmol/L||Standard Error|Least Squares Mean
1307776|NCT02683746|Secondary|Number of Participants With Injection Site Reactions (ISR)|Number of participants with ISR incidences were evaluated at specific time points. Each week included those participants with the onset of an ISR during that particular week as well as those participants with ISR from previous weeks that have not resolved.|Up to Week 34|Safety Population.|||Participants|||Number
1307839|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|Measured at 48 hours after surgery||||milligrams||Standard Deviation|Mean
1307778|NCT02683746|Secondary|Number of Participants With Electrocardiogram (ECG) Parameters of PCC|Single measurements of 12-lead ECG were obtained in semi recumbent position using an ECG machine that automatically calculates the heart rate and measures PR and QT interval corrected for heart rate according to Fridericia’s formula (QTcF). Number of participants with ECG values of PCC at ‘any visit post-Baseline’ are presented. ECG mean heart rate values <50 or >120, PR interval >300 milliseconds (msec), QRS interval >200 msec, QTcF interval >=500 msec were considered as PCC values. Number of participants with PCC values of ECG parameters for 'any visit post-Baseline' are presented.|Up to Week 26|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
1307779|NCT02683746|Secondary|Number of Participants With Vital Signs of PCC|Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a seated position after at least 5 minutes of rest. SBP values <100 millimeters of mercury (mmHg) and >170 mmHg, DBP values <50 mmHg and >110 mmHg, pulse rate values <50 beats per minute (bpm) and >120 bpm were considered as PCC values. Number of participants with PCC values of vital signs for 'any visit post-Baseline' are presented.|Up to Week 34|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
1307780|NCT02683746|Secondary|Number of Participants With Hematology Parameters of PCC|Hematology parameters for which PCC values were identified were hematocrit (if value >0.05 below LLN or >0.04 above ULN), Hemoglobin (Hb) (if value >20 g/L below LLN or >10 g/L above ULN), lymphocytes (if value <0.5*LLN), neutrophils (if value <1 giga unit per liter [GI/L]) and platelets (if value <80 GI/L or >500 GI/L). Number of participants with hematology parameters of PCC at 'any visit post-Baseline' are presented.|Up to Week 26|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
1307781|NCT02683746|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC)|Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >3 * upper limit of normal [ULN]), albumin (if value >5 gram/liter [g/L] above ULN or below lower limit of normal [LLN]), alkaline phosphatase (alk.phosph.) (if value >3*ULN), aspartate aminotransferase (AST) (if value >3*ULN), total bilirubin (if value >1.5 ULN), calcium (if value <1.8 or >3.0 millimoles per liter [mmol/L]), carbon di oxide (CO2) (if value <16 or >40 mmol/L), creatinine (if value >159 micromoles per liter [µmol/L]), direct bilirubin (if value >1.35*ULN), gamma glutamyl transferase (GGT) (if value >3*ULN), potassium (if value >0.5 mmol/L below LLN and >1.0 mmol/L above ULN), protein (if value >15 g/L above ULN or below LLN), sodium (>5 mmol/L below LLN or above ULN), urate (if value >654 µmol/L) and urea (if value >2*ULN). Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented.|Up to Week 26|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
1307782|NCT02683746|Secondary|Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.|Up to Week 26|Safety Population comprised of all enrolled participants who received at least one dose of study treatment.|||Participnats|||Number
1307783|NCT02683746|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26|Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.|Baseline and Week 26|Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment and have a Baseline assessment.|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
1307784|NCT02683707|Secondary|Patient Self-reported Pain|"Patient self report of pain using a visual analog scale (VAS). Scale ranges from 0 to 10 with 0 being No pain and 10 being Most severe pain."|2 hours||||units on a scale||Standard Deviation|Mean
1307785|NCT02683707|Secondary|Platelet Reactivity Using Light Transmission Aggregometry|Blood test of Platelet Cell Reactivity using Light Transmission Aggregometry (reported as percent of baseline aggregation in response to adenosine diphosphate stimulation)|Measured at 2 hours|Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint|||percentage of baseline aggregation||Standard Deviation|Mean
1307786|NCT02683707|Secondary|Single Time-point Platelet Reactivity Using Verify Now|Blood test of Platelet Cell Reactivity using Verify Now (P2Y12 Reactivity Units)|Measured at 2 hours|Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint|||PRUs||Standard Deviation|Mean
1307787|NCT02683707|Primary|Ticagrelor Pharmacokinetics|Area under the curve for Ticagrelor Absorption|Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours)|Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint|||ng*hr/mL||Standard Error|Mean
1307803|NCT02682498|Secondary|Average Daily Patient Pain Score|Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||Visual Analog Scale Rating||Inter-Quartile Range|Mean
1307840|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|Measured at 24 hours after surgery||||units on a scale of 0 to 10||Standard Deviation|Mean
1307788|NCT02683577|Primary|Assessment of Apparent Terminal Elimination Rate Constant (λz) for Telotristat Ethyl and LP-778902 (Active Metabolite)|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl and its active metabolite LP-778902 using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and from 2 to 2000 ng/mL for LP-778902. The LoQ for telotristat ethyl and its metabolite LP-778902 were 0.5 ng/mL and 2.0 ng/mL, respectively.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||hour^-1||Geometric Coefficient of Variation|Geometric Mean
1307789|NCT02683577|Primary|Assessment of t1/2 for Telotristat Ethyl and LP-778902 (Active Metabolite)|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl and its active metabolite LP-778902 using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and from 2 to 2000 ng/mL for LP-778902. The LoQ for telotristat ethyl and its metabolite LP-778902 were 0.5 ng/mL and 2.0 ng/mL, respectively.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||hour||Geometric Coefficient of Variation|Geometric Mean
1307790|NCT02683577|Primary|Assessment of AUC(0-inf) for LP-778902 (Active Metabolite) and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles. AUC(0-inf) was not determined when terminal half-life (t1/2) could not be determined over a time interval equal to at least 2 times t1/2 and/or the adjusted coefficient of determination value was inferior to 0.7 and/or extrapolated AUC was greater than 20%.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307791|NCT02683577|Primary|Assessment of AUC(0-tlast) for LP-778902 (Active Metabolite) and Comparison Between Each Hepatic Impairment Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307792|NCT02683577|Primary|Assessment of Tmax for LP-778902 (Active Metabolite) and Comparison Between Each Hepatic Impairment Group and Healthy Control Group and Comparison Between Each Hepatic Impairment Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||hour||Full Range|Median
1307793|NCT02683577|Primary|Assessment of Cmax for LP-778902 (Active Metabolite) and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307804|NCT02682498|Secondary|Average Daily Opioid Use During Admission|Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||Total Morphine Equivalents||Inter-Quartile Range|Mean
1307805|NCT02682498|Secondary|Recovery Room Opioid Use|Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||Total morphine equivalents||Inter-Quartile Range|Median
1307806|NCT02682498|Primary|48 Hour Post-surgical Opioid Use|A comparison of group means between the control group and study group with regards to 48 hour opioid use.|48 hours||||morphine equivalents||Standard Deviation|Mean
1307794|NCT02683577|Primary|Assessment of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUC[0-inf]) for Telotristat Ethyl|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and the LoQ was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles. AUC(0-inf) was not determined when the apparent terminal elimination half-life (t1/2) could not be determined over a time interval equal to at least 2 times t1/2 and/or the adjusted coefficient of determination value was inferior to 0.7 and/or extrapolated AUC was greater than 20%.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307795|NCT02683577|Primary|Assessment of Area Under the Plasma Concentration Time Curve From 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC[0-tlast]) for Telotristat Ethyl and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and the LoQ was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1307796|NCT02683577|Primary|Assessment of Time to Maximum Observed Plasma Concentration (Tmax) for Telotristat Ethyl and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and the LoQ was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||hour||Full Range|Median
1307797|NCT02683577|Primary|Assessment of Maximum Observed Plasma Drug Concentration (Cmax) for Telotristat Ethyl and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining pharmacokinetic (PK) parameters for total telotristat ethyl using a validated, specific, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 nanograms per millilitre (ng/mL) for telotristat ethyl and the lower limit of quantification (LoQ) was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours [h] post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population (23 subjects overall) corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307798|NCT02683161|Primary|Change in Smoking Status|Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week|Assessed starting in week 2 of 12 weekly study visits||||Mean cigarettes per/day||Standard Deviation|Mean
1307799|NCT02683109|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28|"This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health).~The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT."|Day 28|FAS. One patient in the T 5/O 5 free combination group had missing data for the CAT questionnaire.|||Score on scale||Standard Error|Mean
1307800|NCT02683109|Secondary|Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment|"This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29).~The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC."|Day 29|FAS.|||Liter||Standard Error|Mean
1307801|NCT02683109|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment|"This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5.~The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement."|Day 29|Full Analysis Set (FAS): This patient set is nested within the TS and includes patients who had a baseline measurement and at least one post-baseline measurement for the primary endpoint.|||Liter||Standard Error|Mean
1307802|NCT02682498|Secondary|Post-operative Complications|Examining the post-operative complication in comparison of standard knee injection post-operatively.|Up to 1 month|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||complications|||Number
1307807|NCT02681510|Secondary|Number of Participants Who Reported Quitting at the End of Treatment|Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call|Week 12|All study participants (N=36)|||Participants|||Count of Participants
1307841|NCT02678039|Secondary|Incidence of Epidural Catheter Failure|Percent of epidural catheters that were correctly placed (percentage of catheters).|24 hours after surgery||||percentage of catheters|||Number
1307812|NCT02679976|Primary|Intermediate Binocular LogMAR Visual Acuity|intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.|||-10*LogMAR||Standard Deviation|Mean
1307813|NCT02679976|Primary|Near Binocular LogMAR Visual Acuity|Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.|||-10*LogMAR||Standard Deviation|Mean
1307814|NCT02679976|Primary|Distance Binocular LogMAR Visual Acuity|Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.|||-10*LogMAR||Standard Deviation|Mean
1307815|NCT02679469|Primary|Measure the Terminal-phase Elimination Half-life (T1/2)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose||||hours||Full Range|Median
1307816|NCT02679469|Primary|Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose||||ng･h/mL||Standard Deviation|Mean
1307817|NCT02679469|Primary|‎Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1307818|NCT02678923|Secondary|Participants With Regression Of Coronary Atherosclerosis As Measured By A PAV Change <0|The number of participants with regression of coronary atherosclerosis is presented. For this Outcome Measure, the regression of coronary atherosclerosis is defined as a change in PAV from Baseline to Day 36 of less than zero.|Baseline through Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||Participants|||Count of Participants
1307819|NCT02678923|Secondary|Participants With Regression Of Coronary Atherosclerosis As Measured By A PAV Change Greater Than 2 Standard Deviations Of Test-Retest Measurement Variability|The number of participants with regression of coronary atherosclerosis is presented. For this Outcome Measure, the regression of coronary atherosclerosis is defined as a reduction in PAV from Baseline to Day 36 of greater than 2 standard deviations of the test-retest variability.|Baseline through Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||participants|||Number
1307820|NCT02678923|Secondary|Change From Baseline In TAV For The 10 Millimeters (mm) Subsegment With The Greatest Disease Burden At Day 36|Change in TAV from Baseline to Day 36 post-randomization of the most diseased 10-mm subsegment, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in TAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline TAV for the most diseased 10-mm subsegment as a covariate and treatment group as factor. LS mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||mm^3||Standard Error|Least Squares Mean
1307821|NCT02678923|Secondary|Change From Baseline In Total Atheroma Volume (TAV) At Day 36|Change from Baseline to Day 36 post-randomization in normalized TAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in TAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline TAV as a covariate and treatment group as factor. LS mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
1307822|NCT02678923|Primary|Change From Baseline In Percent Atheroma Volume (PAV) At Day 36|Change from Baseline to Day 36 post-randomization in PAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in PAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline PAV as a covariate and treatment group as factor. Least Squares (LS) mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||change in percent||Standard Error|Least Squares Mean
1307823|NCT02678676|Secondary|Incidences With Malignancies|Percentage of participants with incidences of at least 1 malignancy was reported. All malignancies included adrenal, biliary, bladder, brain, breast, cervix, colon/rectal, gastric, hematological, hepatic, lung, mesothelioma, metastases, oesophageal, oropharyngeal, ovarian/uterine, pancreas, prostate, renal, skin and others.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).|||percentage of participants|||Number
1307824|NCT02678676|Primary|Percentage of Participants With First Occurrence of Macro-vascular Event or Death|The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).|||percentage of participants|||Number
1314903|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN||96 weeks||||participants|participants||Number
1307825|NCT02678286|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 48|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|48 Hours|ITT Population|||Participants|||Count of Participants
1307826|NCT02678286|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 24|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|24 Hours|ITT Population|||Participants|||Count of Participants
1307827|NCT02678286|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24|"Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI~* 24 * 60), and SPID24 < 0 as an indication for improvement."|24 Hours|ITT Population|||Participants|||Count of Participants
1307828|NCT02678286|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
1307829|NCT02678286|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24|"Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI~* 24 * 60), and SPID24 < 0 as an indication for improvement."|24 Hours|ITT Population|||Participants|||Count of Participants
1307830|NCT02678286|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
1307831|NCT02678286|Secondary|Time to Meaningful Pain Relief (TTMPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
1307832|NCT02678286|Secondary|Time to Perceptible Pain Relief (TTPPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
1307833|NCT02678286|Secondary|Number of Doses of Rescue Analgesia Utilized Per Subject|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||doses of rescue analgesia||Standard Error|Least Squares Mean
1307834|NCT02678286|Secondary|Number of Subjects Utilizing Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||Participants|||Count of Participants
1307835|NCT02678286|Secondary|Time to First Dose of Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.|48 Hours|ITT Population|||hours||95% Confidence Interval|Median
1307836|NCT02678286|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1307837|NCT02678286|Primary|Summed Pain Intensity Difference Over the First 24 Hours (SPID24)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|24 Hours|Intent-to-Treat (ITT) population|||units on a scale||Standard Error|Least Squares Mean
1307838|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|3 months after surgery during follow up office visit with surgeon|Insufficient data were collected for this analysis||||||
1307842|NCT02678039|Primary|Intravenous Pain Medication|Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain.|24 hours after surgery||||milligrams||Standard Deviation|Mean
1307843|NCT02677844|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Loperamide|Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.|Day -3: Predose,1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose|All randomized participants in Cohort 2 Period 4 (DDI) who received Loperamide & had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307844|NCT02677844|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point With Measurable Concentration [AUC(0-tlast)] of Loperamide|Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.|Day -3: Predose, 1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose|All randomized participants in Cohort 2 Period 4 (DDI) who received Loperamide & had evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1307845|NCT02677844|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Last Time Point With Measurable Concentration AUC(0-tlast) of Abemaciclib|Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib 0-tlast.|Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose|All randomized participants who received at least one dose of study drug in Cohort 1 all periods & Cohort 2 periods 5,6, and 7 with evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1307846|NCT02677844|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib|Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib.|Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose|All randomized participants who received at least one dose of study drug in Cohort 1 all periods & Cohort 2 periods 5,6, and 7 with evaluable PK data.|||Nanogram per Milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1307847|NCT02677844|Primary|Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia’s Corrected QT Interval (ΔΔQTcF)|"QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data. ECG monitoring was conducted using a 12-lead digital Holter recorder from approximately 2 hours predose through 24 hours postdose on Day 1 of each period using 12-lead digital Holter recorder.~Fridericia-corrected QT interval (QTcF): QTcF = QT/RR1/3, where RR is the interval between two R waves."|Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post Dose|All randomized participants who received at least one dose of study drug and had baseline and post baseline QTcF values.|||Millisecond (msec)||90% Confidence Interval|Mean
1307848|NCT02677779|Secondary|Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis|proportion of patients with bleeding necessitating haemostasis|during procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.|||participants|||Number
1307849|NCT02677779|Secondary|Granulation: Percent of Ulcer Area Covered by Granulation.|Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.|Baseline and immediately after procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.|||Percent change from baseline||Inter-Quartile Range|Median
1307850|NCT02677779|Secondary|Fibrin: Percent of Ulcer Area Covered by Fibrin|Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure|Baseline and immediately after the end of procedure||||Percent change from baseline||Inter-Quartile Range|Median
1307851|NCT02677779|Secondary|Pain: Scores of Brief Pain Inventory|Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.|During procedure.|ITT analysis: patients with no detectable bacterial load at baseline were included.|||cm for a VAS scale.||Inter-Quartile Range|Median
1307852|NCT02677779|Primary|Bacterial Load|Percent change in bacterial colonies from baseline.|Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.|Per-protocol analysis: patients with no detectable bacterial load at baseline were excluded.|||Percent change from baseline||Inter-Quartile Range|Median
1307853|NCT02677493|Secondary|Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28|||||||
1307854|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28|||||||
1307855|NCT02677493|Secondary|Difference in Seroconversion Rate||Day 28|||||||
1307856|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).||Day 28|||||||
1307857|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.||Day 28||2017-07-31|07/2017||||
1307858|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroconversion, Respectively.|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28||2017-07-31|07/2017||||
1307859|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroprotection|Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.|||percentage of subjects||95% Confidence Interval|Number
1307928|NCT02671760|Secondary|Safety and Tolerability in Terms of Residual Sleepiness|Karolinska Sleepiness Scale. This is a 9-point scale with values ranging from 1 (extremely alert) to 9 (extremely sleepy). Lower scores indicate less residual sleepiness.|8 hours||||Units on a scale||Standard Deviation|Mean
1307860|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroconversion|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.|||percentage of subjects||95% Confidence Interval|Number
1307861|NCT02675907|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 48|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|48 Hours||||Participants|||Count of Participants
1307862|NCT02675907|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 24|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|24 Hours||||Participants|||Count of Participants
1307863|NCT02675907|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.|24 Hours|ITT Population|||Participants|||Count of Participants
1307864|NCT02675907|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
1307865|NCT02675907|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.|24 Hours|ITT Population|||Participants|||Count of Participants
1307866|NCT02675907|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
1307867|NCT02675907|Secondary|Time to Meaningful Pain Relief (TTMPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
1307868|NCT02675907|Secondary|Time to Perceptible Pain Relief (TTPPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
1307869|NCT02675907|Secondary|Number of Doses of Rescue Analgesia Utilized Per Subject|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||doses of rescue analgesia||Standard Error|Least Squares Mean
1307870|NCT02675907|Secondary|Number of Subjects Utilizing Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||Participants|||Count of Participants
1307871|NCT02675907|Secondary|Time to First Dose of Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.|48 Hours|ITT Population|||hours||95% Confidence Interval|Median
1307872|NCT02675907|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1307929|NCT02671760|Secondary|Adverse Events|Safety and tolerability assessed in terms of the incidence of AEs|8 hours||||Number of Events|||Number
1307930|NCT02671760|Secondary|Latency to REM Sleep Onset|Time required to achieve REM sleep|8 hours||||minutes||Standard Deviation|Mean
1307931|NCT02671760|Secondary|Awakenings||8 hours||||Awakenings||Standard Deviation|Mean
1307873|NCT02675907|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|Intent-to-Treat (ITT) population|||units on a scale||Standard Error|Least Squares Mean
1307874|NCT02675764|Other Pre-specified|Hand Strength|change in maximum grip force measured on grip force dynamometer|post intervention (about a week after the 2-week therapy, or week 3) and follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)|||||||
1307875|NCT02675764|Other Pre-specified|Patient-centered Outcome|change in self-reported function assessed using the Stroke Specific Quality of Life and Stroke Impact Scale|post intervention (about a week after the 2-week therapy, or week 3) and follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)|||||||
1307876|NCT02675764|Other Pre-specified|Hand Sensation|change in hand sensation as measured by the Two-point Discrimination Test, Grating Orientation Task, and Semmes-Weinstein Monofilament Test|post intervention (about a week after the 2-week therapy, or week 3) and follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)|||||||
1307877|NCT02675764|Other Pre-specified|Brain Activity for Grip|change in the EEG peak-to-peak power change observed with grip|post intervention (about a week after the 2-week therapy, or week 3) and follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)|||||||
1307878|NCT02675764|Other Pre-specified|Brain Activity for Grip|change in the blood oxygen level dependent (BOLD) signal intensity with grip|post intervention compared to baseline|||||||
1307879|NCT02675764|Other Pre-specified|Arm Function|change in arm function as measured by using the Action Research Arm Test and Fugl-Meyer Upper Extremity|post intervention (about a week after the 2-week therapy, or week 3) and follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)|||||||
1307880|NCT02675764|Other Pre-specified|Bimanual Hand Manipulation|change in bimanual hand manipulation as assessed by using the Purdue Peg Board Test|post intervention (about a week after the 2-week therapy, or week 3) and follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)|||||||
1307881|NCT02675764|Other Pre-specified|Diffusion Kurtosis Imaging (DKI)|change in diffusion kurtosis imaging (DKI)|post intervention compared to baseline|||||||
1307882|NCT02675764|Other Pre-specified|Corticomotor Excitability Measured by Transcranial Magnetic Stimulation|change in corticomotor excitability measured by transcranial magnetic stimulation|post intervention (about a week after the 2-week therapy, or week 3) and follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)|||||||
1307883|NCT02675764|Primary|WMFT at Least 2 Weeks After the 2-week Intervention|change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.|follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)||||change in ln(sec)||Standard Error|Mean
1307884|NCT02675764|Primary|WMFT About a Week After the 2-week Intervention|change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.|post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)||||change in ln(sec)||Standard Error|Mean
1307885|NCT02675764|Primary|Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention|Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.|follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)||||change in # of blocks||Standard Error|Mean
1307886|NCT02675764|Primary|Box and Block Test (BBT) About a Week After the 2-week Intervention|Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.|post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)||||change in # of blocks||Standard Error|Mean
1307887|NCT02675634|Primary|Fit to Body|"Subjects will evaluate the fit to body for each product by answering the question how was the baseplates ability to fit the body contours in the area around the stoma? The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question."|14 +/- 2 days||||percentage of good or very good|||Number
1307888|NCT02675543|Primary|Vitreous Prostaglandin E2 Levels||intraoperarive||||pg/mL||Standard Deviation|Mean
1307889|NCT02674412|Secondary|Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.|A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg|14 days||||percentage of swallows||Standard Deviation|Mean
1307890|NCT02674412|Secondary|Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score|A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD).|Change in the score from Baseline to 14 days||||Scores on a scale||Standard Deviation|Mean
1307891|NCT02674412|Primary|Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry|DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal.|Change in the score from Baseline to 14 days||||mm Hg||Standard Deviation|Mean
1307932|NCT02671760|Secondary|Latency to Persistent Sleep|Time it takes to fall asleep|8 hours||||minutes||Standard Deviation|Mean
1307892|NCT02674334|Secondary|Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value|Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) > 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value.|baseline and up to two weeks|Participants who underwent elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.|||scores on a scale|participants|Standard Error|Mean
1307893|NCT02674334|Primary|Percentage of Participants With 20+% Cerebral Desaturation Events|Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position|one day|Participants undergoing elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.|||Participants|||Count of Participants
1307894|NCT02673944|Primary|Accurate Vesical PRessure|To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.|During a routine urodynamic study (1 hr approx)||||cm H2O||Standard Deviation|Mean
1307895|NCT02673619|Secondary|Number of Participants With Local Tolerability Assessments|Skin tolerability was assessed by a 5-point tolerability scale ranging from 0 to 4; where 0 (no irritation), 1 (mild), 2 (moderate), 3 (severe) to 4 (Very Severe).The participants with data available at specified time points were represented by n=x in the category titles.|Day 1, 8, 15, 22, 27, 28, 29, 30, 36 and 43|Safety Population|||Participants|||Number
1307896|NCT02673619|Secondary|Change From Baseline in Weight|Weight measurement was performed as a measure of safety. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value.|Baseline and Up to Day 29|Safety Population|||Kilograms (Kg)||Standard Deviation|Mean
1307897|NCT02673619|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a seated position, after 5 minutes rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.|Baseline, Day 15, 27, 28 and 29|Safety Population|||Beats/minute (min)||Standard Deviation|Mean
1307898|NCT02673619|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs including SBP and DBP were measured in a seated position, after 5 minutes rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.|Baseline, Day 15, 27, 28 and 29|Safety Population|||Millimiters of mercury (mmHg)||Standard Deviation|Mean
1307899|NCT02673619|Secondary|Change From Baseline in Body Temperature Assessment as a Safety Measure|Body temperature was measured as a vital sign in seated position, after 5 min rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.|Baseline, Day 15, 27, 28 and 29|Safety Population|||Celsius (C)||Standard Deviation|Mean
1307900|NCT02673619|Secondary|Number of Participants With Abnormal Urine Analysis|Urine sample were taken to analyze glucose and protein levels, blood and ketones body.Urinalysis analytes were measured by dipstick test. Results have been reported in a semi-quantitative manner as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations of the analyte in the urine sample. Abnormal laboratory values have been presented in the table. The participants with data available at specified time points were represented by n=x in the category titles.|Day 1, 15 and 29|Safety Population|||Participants|||Number
1307901|NCT02673619|Secondary|Number of Participants With Abnormal Values of Chemistry Parameters Assessment as a Safety Measure|"Blood samples were collected to analyze the abnormal clinical chemistry parameters by Potential Clinical Importance Criteria. The data was presented for only those parameters for which abnormal values were found (calcium, alanine aminotransferase [ALT]). Participants in the higher dose cohort (UMEC group) had abnormal calcium values and for ALT, the abnormal values were found in lower dose cohort (UMEC group). Hence, data was presented only for these specific cohorts. Participants were counted in the category for their values > ref range high and < ref range low. The measurements taken at Day 1, Day 15 and Day 29 were presented. The participants with data available at specified time points were represented by n=x in the category titles. n=0 in category titles represents that the data was not available for participants in respective category or arm."|Day 1, 15 and 29|Safety Population. This outcome measures the number of participants with abnormal values of clinical chemistry parameters, therefore, only the summary for the cohort/lab parameter with abnormal data at a certain time point was presented.|||Participants|||Number
1307902|NCT02673619|Secondary|Number of Participants With Abnormal Values of Hematological Parameters|Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Chemistry Criteria. The data was presented for only those hematology parameters for which abnormal values were found (neutrophils and hemoglobin) . During the analysis, no participant in the higher dose cohort- vehicle group, nor in the lower dose cohort (for both UMEC and vehicle groups) had abnormal hematology values that met the pre-specified criteria for potential clinical importance. Hence, the data for only higher dose cohort was presented. The measurements taken at Day 29 were presented. Participants were counted in the category for their values greater than (>) reference (ref) range high and less than (<) ref range low. The participants with data available at specified time points were represented by n=x in the category titles.|Day 29|Safety Population. This outcome measures the number of participants with abnormal values of hematological parameters, therefore, only the summary for the cohort/lab parameter with abnormal data at a certain time point was presented.|||Participants|||Number
1307903|NCT02673619|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single measurements of 12-lead ECGs were obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG values were recorded as abnormal not clinically significant (NCS) and abnormal clinically significant (CS). The participants with data available at specified time points were represented by n=x in the category titles.|Day 1, 15 and 29|Safety Population|||Participants|||Number
1307904|NCT02673619|Secondary|Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAE's)|An AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward medical occurrence that, that results in death, life-threatening, requires hospitalization or prolongation of existing hospitalization, disability/incapacity, any a congenital anomaly/birth defect or other situations at any dose.|Up to Day 43|This analysis was performed on safety population comprised of all participants who received study medication.|||Participants|||Number
1307905|NCT02673619|Secondary|Population Pharmacokinetic Profile After Repeat Dosing of UMEC|Population pharmacokinetic profiling was planned to characterize the population pharmacokinetics of UMEC administered topically to both palms in participants with palmar hyperhidrosis. Due to the fact that the majority of the pharmacokinetic samples were below the limit of quantitation, a population pharmacokinetic analysis could not be performed.|Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population||||||
1307906|NCT02673619|Secondary|Plasma Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau)|Trough (pre-dose at the end of each dosing interval) plasma concentration (Ctau) was analyzed at indicated time-points. Trough concentration samples were used for the assessment/attainment of steady state (ss). Samples were collected at nominal times relative to the proposed time of UMEC dosing. NA represents the data was not available for specific arm or category.|Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1307907|NCT02673619|Secondary|The Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and AUC Over the Dosing Interval Tau, [AUC(0-tau)] After Repeat Dosing of UMEC|Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) and AUC(0-tau) was calculated by the linear up and log down trapezoidal method. Samples were collected at nominal times relative to the proposed time of UMEC dosing. The participants with data available at specified time points were represented by n=x in the category titles.|Pre dose on Day 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population|||Log (h*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1307908|NCT02673619|Secondary|The Apparent Terminal Phase Half-life (t1/2) After Repeat Dosing of UMEC|Blood samples were planned to be collected to measure t1/2. The outcome measure was not analyzed due to lack of data availability.|Day 28|PKCNC Population. The terminal phase half-life could not be derived for any of the participants included in the study because of insufficient data in the elimination phase.||||||
1307909|NCT02673619|Secondary|The Terminal Plasma Elimination Rate Constant (Lambda z)|Blood samples were planned to be collected to measure Lambda Z. The outcome measure was not analyzed due to lack of data availability.|Day 28|PKCNC Population. The terminal plasma elimination rate constant could not be derived for any of the participants included in the study because of insufficient data in the elimination phase.||||||
1307910|NCT02673619|Secondary|Time of the Maximum Measured Plasma Concentration (Tmax) After Repeat Dosing of UMEC|Blood samples were collected to measure Tmax at indicated time-points. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Mean and standard deviation has been presented for Tmax values.|Pre dose on Day 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population|||Hours||Standard Deviation|Mean
1307911|NCT02673619|Secondary|Maximum Plasma Concentration (Cmax)|Blood samples were collected to measure Cmax at Day 28. Cmax is the maximum observed concentration, determined directly from the concentration-time data. The geometric mean and geometric coefficient were presented for all log transformed Cmax values.|Day 28|PKCNC Population|||Log (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1307912|NCT02673619|Secondary|Plasma Concentration After Repeat Dosing of UMEC|Blood samples were collected at indicated time points. Samples were collected at nominal times relative to the proposed time of UMEC dosing. NA represents that the values were not available for specific arm or category. The participants with data available at specified time points were represented by n=x in the category titles.|Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|The analysis was performed on pharmacokinetic concentration (PKCNC) Population , comprised of all participants in the Safety set for whom at least one pharmacokinetic sample was obtained and analyzed.|||Picogram/milliliter (pg/mL)||Standard Deviation|Mean
1307913|NCT02673619|Secondary|Percentage of Participants With at Least 2-point Decrease From Baseline to Day 29 in HDSS Score|The HDSS was assessed based on a score 1 to 4. The HDSS is a 4-point scale ranging from 1 (sweating never noticeable and never interferes daily activities), 2 (sweating tolerable but sometimes interferes daily activities), 3 (sweating barely tolerable and frequently interferes daily activities) and 4 (sweating intolerable and always interferes daily activities). Baseline value was the latest assessment prior to first dosing. The summary of percentage of participants from both the cohorts with at least 2-point decrease from Baseline in HDDS scores was presented.|Baseline and Day 29|Full Analysis Population|||Percentage of participants|||Number
1307914|NCT02673619|Secondary|Number of Participants With Shift of Response in HDSS Score at Day 29|The HDSS was assessed based on a score 1 to 4 .The HDSS is a 4-point scale ranging from 1 (sweating never noticeable and never interferes daily activities), 2 (sweating tolerable but sometimes interferes daily activities), 3(sweating barely tolerable and frequently interferes daily activities) and 4 (sweating intolerable and always interferes daily activities s). A shift table describing change in response in participants from 1.85 percent cohort to 1.15 percent cohort has been presented for weekly average HDSS scores.|Baseline and Day 29|Full Analysis Population|||Participants|||Number
1307915|NCT02673619|Secondary|Percentage Change From Baseline/Day1 in Amount of Sweat Produced at Day 29|The amount of sweat produced was assessed by gravimetric measurement . Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. Baseline value was the latest assessment prior to first dosing. The latest pre-dose value was considered as Baseline value. Percentage change from Baseline was calculated with post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. The summary of percentage change from Baseline in sweat production was presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Percentage change of sweat produced||Standard Deviation|Mean
1307933|NCT02671760|Primary|Total Sleep Time||8 hours||||minutes||Standard Deviation|Mean
1307916|NCT02673619|Secondary|Change From Baseline in Amount of Sweat Produced at Day 29|The amount of sweat produced was assessed by gravimetric measurement . Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. Baseline value was the latest assessment prior to first dosing. The latest pre-dose value was considered as Baseline value.Change from Baseline value was calculated by post-dose visit value minus Baseline value. The summary of change from Baseline in sweat production has been presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Milligrams (mg)||Standard Deviation|Mean
1307917|NCT02673619|Secondary|Percentage of Participants With at Least 50% Reduction From Baseline in Sweat Production at Day 29|Percentage of participants at Day 29 post-treatment with at least a 50 percent reduction from Baseline in sweat production was measured by gravimetric analysis. Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. The latest pre-dose value was considered as Baseline value. The summary of percentage of participants from both the cohorts with at least 50 percent reduction from Baseline in sweat production was presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Percentage of participants|||Number
1307918|NCT02673619|Primary|Percentage of Participants With at Least 30 Percent Reduction From Baseline in Sweat Production at Day 29|Percentage of participants at Day 29 post-treatment with at least a 30 percent reduction from Baseline in sweat production measured by gravimetry. Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. The latest pre-dose value was considered as Baseline value. The summary of percentage of participants from both the cohorts with at least 30 percent reduction from Baseline in sweat production was presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Percentage of participants|||Number
1307919|NCT02673619|Primary|Posterior Probability That the Response Rate is Greater Than 50%|A response rate is defined as percentage of participants who achieved at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29. Baseline was latest assessment prior to first dosing. A response rate of greater than 50 percent was considered to be clinically meaningful (greater than 50 percent of participants achieving at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29). The posterior probability that response rate in sweat production is greater than 50 percent was analyzed. The evaluation was performed using Bayesian analysis, in which latest pre-dose value was used as Baseline.|Baseline and Day 29|This analysis was based on full analysis population comprised of all participants receiving study medication and having at least 1 non-missing change from Baseline efficacy assessment at/before Day 29.This analysis assessed whether response rate in UMEC arm exceeded a threshold that would warrant further development and is not relevant for vehicle.|||Posterior Probability|||Number
1307920|NCT02673489|Secondary|Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24|"HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up.~Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria."|At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24|All treated participants|||Percentage||95% Confidence Interval|Number
1307921|NCT02673489|Secondary|Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24|HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach.|At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)|All treated participants|||Percentage||95% Confidence Interval|Number
1307922|NCT02673489|Secondary|Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.|Week 12 (Follow-up period)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1307923|NCT02673489|Primary|Percentage of Participants With Sustained Virologic Response (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.|Week 12|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1307924|NCT02672514|Primary|Acute Kidney Injury||within the first 30 days (plus or minus 3 days) after surgery||||participants|||Number
1307925|NCT02672423|Primary|PK: Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration.|Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1307926|NCT02672423|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])|Area under the concentration versus time curve from zero to infinity.|Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1307927|NCT02671760|Secondary|Safety and Tolerability in Terms of Residual Sleepiness|Digit Symbol Substitution Test. The test score is number of correct answers in 90 seconds. Higher scores indicate favorable response (i.e., less residual sleepiness). The duration of the challenge is the 90 second time limit; there is no theoretical maximum score to attain.|8 hours||||Correct answers||Standard Deviation|Mean
1312119|NCT02517021|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase||0-120 hours||||Participants|||Count of Participants
1307934|NCT02671461|Secondary|Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death|The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.|Day 90|The trial was prematurely terminated. Due to the short trial duration and as a result of limited participant follow-up, insufficient data was collected (or did not exist as the imagining assessments from the Imagining Adjudication Committee were not performed) to allow for statistical analysis as described in the protocol.||||||
1307935|NCT02671461|Secondary|Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90|The percentage of participants with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated participants.|Day 90|The trial was prematurely terminated. Due to the short trial duration and as a result of limited participant follow-up, insufficient data was collected (or did not exist as the imagining assessments from the Imagining Adjudication Committee were not performed) to allow for statistical analysis as described in the protocol.||||||
1307936|NCT02671461|Secondary|Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)|The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants.|Day 28|The trial was prematurely terminated. Due to the short trial duration and as a result of limited participant follow-up, insufficient data was collected (or did not exist as the imagining assessments from the Imagining Adjudication Committee were not performed) to allow for statistical analysis as described in the protocol.||||||
1307937|NCT02671461|Secondary|Percentage of Participants With Major Adverse Cardiovascular Events (MACE)|MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated participants experiencing these events at Day 90 was to be reported by arm.|90 days|The trial was prematurely terminated. Due to the short trial duration and as a result of limited participant follow-up, insufficient data was collected (or did not exist as the imagining assessments from the Imagining Adjudication Committee were not performed) to allow for statistical analysis as described in the protocol.||||||
1307938|NCT02671461|Primary|Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period|The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.|Up to 90 days|The trial was prematurely terminated. Due to the short trial duration and as a result of limited participant follow-up, insufficient data was collected (or did not exist as the imagining assessments from the Imagining Adjudication Committee were not performed) to allow for statistical analysis as described in the protocol.||||||
1307939|NCT02671461|Primary|Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28|The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.|28 Days|The trial was prematurely terminated. Due to the short trial duration and as a result of limited participant follow-up, insufficient data was collected (or did not exist as the imagining assessments from the Imagining Adjudication Committee were not performed) to allow for statistical analysis as described in the protocol.||||||
1307940|NCT02670811|Secondary|Triglycerides Measurements|Triglycerides measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
1307941|NCT02670811|Secondary|High Density Lipoproteins|High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
1307942|NCT02670811|Secondary|Low Density Lipoproteins Measurements|Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
1307943|NCT02670811|Secondary|Total Cholesterol Measurements|Total cholesterol in baseline and after 8 weeks of treatment (Intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
1307944|NCT02670811|Secondary|Diastolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks post-treatment.|Baseline to 10 weeks||||mmHg||Standard Deviation|Mean
1307945|NCT02670811|Primary|Systolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.|Baseline to 10 weeks||||mmHg||Standard Deviation|Mean
1307946|NCT02670473|Secondary|Corneal Staining|Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
1307947|NCT02670473|Secondary|Conjunctival Staining|Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
1307948|NCT02670473|Secondary|Wearing Times|Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.|Baseline, 1 week, 2 weeks, and 4 weeks||||hours||Standard Deviation|Mean
1307949|NCT02670473|Secondary|Lens Preference Overall|Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).|1 week, 2 weeks, and 4 weeks|One participant withdrew from the study after week 1.|||percentage of subjects|||Number
1307950|NCT02670473|Secondary|Overall Satisfaction|Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.|Baseline, 1 week, 2 weeks, and 4 weeks|One participant withdrew from the study after week 1.|||percentage of subjects|||Number
1307951|NCT02670473|Secondary|Overall Vision Satisfaction|Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
1307952|NCT02670473|Secondary|Handling|Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
1307953|NCT02670473|Secondary|Dryness Overall|Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
1307954|NCT02670473|Secondary|Overall Comfort|Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
1307955|NCT02670473|Primary|Overall Fit Acceptance|Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
1307956|NCT02670473|Primary|Lens Tightness on Push-up|Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of lens tightness||Standard Deviation|Mean
1307957|NCT02670473|Primary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
1307958|NCT02670473|Primary|Lens Fit - Centration|Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
1307959|NCT02670343|Primary|% of Mean Difference in T Concentration Compared to Plain Collection Tube|"The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube.~The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab."|Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.||||Difference as % of Mean of T results||Standard Deviation|Mean
1307960|NCT02669095|Primary|Overall Comfort|Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.|Up to 4 Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
1307961|NCT02669095|Primary|Acceptable Lens Fitting|Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.|Up to 4 Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Proportion of eyes|Subject Eyes||Number
1307962|NCT02669043|Primary|Hamilton Depression Rating Scale (HDRS, HAM-D)|Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.|48 hours|Patients who completed the study. Outcome measure was at 48 hours.|||units on a scale||Full Range|Mean
1307963|NCT02668952|Secondary|Serum Chloride at 48 Hours|Serum chloride measurement at 48 hours postoperatively|2 days||||mmol/L||Standard Deviation|Mean
1307964|NCT02668952|Secondary|Serum Creatinine Level at 48 Hours|Serum creatinine level 48 hours postoperatively|2 days||||mg/dL||Standard Deviation|Mean
1307965|NCT02668952|Secondary|Postoperative Arterial pH|Arterial pH, measured 24 hours after surgery|One day||||pH||Standard Deviation|Mean
1307966|NCT02668952|Secondary|Proportion of Patients With Need for Dialysis|Clinically-determined need for dialysis prior to discharge from hospital|One week||||percentage of patients|||Number
1307967|NCT02668952|Secondary|Serum Chloride Level at 24 Hours|Serum chloride ion measurement at 24 hours postoperatively|1 day||||mmol/L||Standard Deviation|Mean
1307968|NCT02668952|Secondary|Serum Creatinine Level at 24 Hours|Serum creatinine measurement at 24 hours|1 day||||mg/dL||Standard Deviation|Mean
1307969|NCT02668952|Primary|Change in [TIMP2]*[IGFBP7] Biomarker|The difference in the [TIMP2]*[IGFBP7] biomarker between the preoperative value and a repeated measurement at 24 hours postoperatively. Positive values represent increase; negative values represent decrease|Baseline and postoperatively at 24 hours||||(ng/mL)^2/1000||Standard Deviation|Mean
1307983|NCT02668783|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 128 days|All randomized participants in whom a vaginal ring was inserted.|||Participants|||Number
1307970|NCT02668822|Secondary|Change From Baseline in the Mean Pelvic Pain Score at Treatment Cycle 2|The mean pelvic pain score was to be calculated as the mean of the highest scores for pelvic pain observed within the 4-day cramping window of the screening or treatment cycle. The baseline mean pelvic pain score was to be defined as the mean value of the 2 mean pelvic pain scores of the 2 menstruations during the screening period. The change from baseline in mean pelvic pain score at Treatment Cycle 2 was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
1307971|NCT02668822|Secondary|Percentage of Participants With ≥3-point Reduction in Peak Pelvic Pain Score and a Decrease in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and a decrease in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
1307972|NCT02668822|Secondary|Percentage of Participants With Pelvic Pain Score of “0” or “1” and no Use of Ibuprofen Tablets at Treatment Cycle 2|Participants were asked to rate their worst pain or cramps on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The percentage of participants with no or minimal pelvic pain (score of “0” or “1”) and no use of ibuprofen at Treatment Cycle 2 was to be presented.|Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during Treatment Cycle 2. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
1307973|NCT02668822|Secondary|Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2|Participants were asked to indicate how much pain or cramps limited their physical, work/school and social/leisure activities and over the previous 24 hours. The level of negative impact of dysmenorrhea on daily life was scored on a 5-point scale (0=Not at all to 4=Extremely impacted). For each of the 3 impact items, the baseline score was to be defined as the mean value obtained from the 2 menstruations during the screening period. The change from baseline to Treatment Cycle 2 in the number of days during the cramping window with no impact of dysmenorrhea (score = 0) on each of the following items was to be presented: work/school, physical activities and leisure/social activities.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
1307974|NCT02668822|Secondary|Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps). The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the 4-day cramping window of the cycle. The baseline peak pelvic pain score was to be defined as the mean value of the 2 peak pelvic pain scores during the cramping window of each of the 2 menstruations during the screening period. The change from baseline in peak pelvic pain score at Treatment Cycle 2 was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
1307975|NCT02668822|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due an AE is presented.|Up to approximately 112 days|The population consisted of all participants in whom a vaginal ring was inserted.|||Participants|||Number
1307976|NCT02668822|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented.|Up to approximately 126 days|The population consisted of all participants in whom a vaginal ring was inserted.|||Participants|||Number
1307984|NCT02668783|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented.|Up to approximately 158 days|All randomized participants in whom a vaginal ring was inserted.|||Participants|||Number
1312120|NCT02517021|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
1307977|NCT02668822|Primary|Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the cramping window of the cycle and the total number of ibuprofen tablets taken was to be based on the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and no increase in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
1307978|NCT02668783|Secondary|Change From Baseline in Mean Pelvic Pain Score at Treatment Cycle 2|The mean pelvic pain score was to be calculated as the mean of the highest scores for pelvic pain observed within the 4-day cramping window of the screening or treatment cycle. The baseline mean pelvic pain score was to be defined as the mean value of the 2 mean pelvic pain scores of the 2 menstruations during the screening period. The change from baseline in mean pelvic pain score at Treatment Cycle 2 was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
1307979|NCT02668783|Secondary|Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and a Decrease in Ibuprofen Tablet Intake at Treatment Cycle 2, Compared to Baseline|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and a decrease in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
1307980|NCT02668783|Secondary|"Percentage of Participants With Pelvic Pain Score of 0 or 1 and no Use of Ibuprofen Tablets at Treatment Cycle 2"|Participants were asked to rate their worst pain or cramps on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The percentage of participants with no or minimal pelvic pain (score of “0” or “1”) and no use of ibuprofen at Treatment Cycle 2 was to be presented.|Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during Treatment Cycle 2. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
1307981|NCT02668783|Secondary|Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2|Participants were asked to indicate how much pain or cramps limited their physical, work/school and social/leisure activities and over the previous 24 hours. The level of negative impact of dysmenorrhea on daily life was scored on a 5-point scale (0=Not at all to 4=Extremely impacted). For each of the 3 impact items, the baseline score was to be defined as the mean value obtained from the 2 menstruations during the screening period. The change from baseline to Treatment Cycle 2 in the number of days during the cramping window with no impact of dysmenorrhea (score = 0) on each of the following items was to be presented: work/school, physical activities and leisure/social activities.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
1307982|NCT02668783|Secondary|Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2|"Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps).~The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the 4-day cramping window of the cycle. The baseline peak pelvic pain score was to be defined as the mean value of the 2 peak pelvic pain scores during the cramping window of each of the 2 menstruations during the screening period. The change from baseline in peak pelvic pain score at Treatment Cycle 2 was to be presented."|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
1308053|NCT02663232|Secondary|Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1307985|NCT02668783|Primary|Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline.|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the cramping window of the cycle and the total number of ibuprofen tablets taken was to be based on the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and no increase in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
1307986|NCT02667821|Other Pre-specified|Changes in Blood Flow Through Vertebral Artery|Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood flow (mL/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05|The series of fMRI sequences will be performed on each participant immediately after each procedure.||||mL/s||Standard Deviation|Mean
1307987|NCT02667821|Secondary|Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.|ASL allows one to separate the blood flow from the BOLD effect, thus giving clear measures of perfusion. More specifically ASL will be used to measure blood perfusion and allow extraction of metabolic difference from flow differences in BOLD imaging. It is a quantitative technique, yielding values with units of ml/(100g of tissue)·min-1.|The series of ASL sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.||||ml/100g of tissue/minute||Standard Deviation|Mean
1307988|NCT02667821|Primary|Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation|Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood velocity (cm/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05|The series of fMRI sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.||||cm/s||Standard Deviation|Mean
1307989|NCT02667704|Secondary|Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-infinity was calculated for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.|||ng*h / mL||Geometric Coefficient of Variation|Geometric Mean
1307990|NCT02667704|Primary|Maximum Measured Concentration of Nintedanib in Plasma (Cmax)|Maximum measured concentration of Nintedanib in plasma (Cmax). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. Cmax was determined for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1307991|NCT02667704|Primary|Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Concentration (AUC0-tz)|Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 to the last quantifiable concentration (AUC0-tz). PK plasma samples were taken at: 1 hour (h) before drug administration (approximate time for predose sample) and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-tz was calculated for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.|||nanogram (ng)*hour (h) /millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1308054|NCT02663232|Secondary|Percentage of Participants With Vascular Invasion|Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1307992|NCT02667288|Secondary|Per Subject Percent of Lesion Clearance|Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions.|Day 148|Per Protocol Population|||percentage of lesions cleared||Standard Deviation|Mean
1307993|NCT02667288|Primary|Proportion of Subjects With Lesion Clearance|Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.|Study day 148|ITT Population|||Participants|||Count of Participants
1307994|NCT02667275|Secondary|Percent of Lesions Cleared Scale|Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8|Study day 106||||Participants|||Count of Participants
1307995|NCT02667275|Primary|Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale|Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.|Study day 106||||Participants|||Count of Participants
1307996|NCT02667236|Secondary|Proportion of Subjects With 3 of 4 Target Lesion Clearance|Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8|Day 106 of the study|ITT population; all randomized subjects|||Participants|||Count of Participants
1307997|NCT02667236|Primary|Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment|Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.|Day 106 of the study|ITT Population; all randomized subjects|||Participants|||Count of Participants
1307998|NCT02666560|Secondary|Time Spent in Single Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||percentage of time||Standard Deviation|Mean
1307999|NCT02666560|Secondary|Time Spent in Double Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||percentage of time||Standard Deviation|Mean
1308000|NCT02666560|Secondary|Cadence as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of cadence was recorded in steps per minute.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||steps per minute||Standard Deviation|Mean
1308001|NCT02666560|Secondary|Step Time as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of step time was recorded in seconds.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||seconds||Standard Deviation|Mean
1308002|NCT02666560|Secondary|Velocity as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of velocity was recorded in cm's per second.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||cm/s||Standard Deviation|Mean
1308003|NCT02666560|Primary|Step Length as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of length was recorded in centimetres.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||cm||Standard Deviation|Mean
1308004|NCT02666222|Secondary|Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire|"APHAB results were obtained from baseline aided condition through Year 5 of follow up. The APHAB responses are in terms of percent of time an individual experiences problems, on a scale of 0-100%; lower scores indicate fewer problems.Compared scores with Esteem to scores in baseline aided condition, calculated as APHAB Global score at baseline minus APHAB Global score at Year 5, giving a difference in benefit score. The Global Score is the mean of the scores (% of problems) for Ease of Communication (EC), Reverberation (RV), and Background Noise (BN) subscales of the APHAB. A positive difference in benefit score indicates more benefit with Esteem."|Baseline through Year 5 of Follow Up|5 Year Follow-up|||difference score in units on a scale||Full Range|Mean
1308005|NCT02666222|Primary|Bone Conduction Stability|ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.|Baseline through 5 Year Follow-Up|Difference between Baseline and 5 Year PTA (average of 500, 1000, 2000 Hz thresholds)|||dB||Standard Error|Mean
1308006|NCT02666222|Primary|Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.|ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.|SADEs, PAS phase through Year 5 of Follow Up|Cumulative through 5-Year Follow-up|||participants|||Number
1308007|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL|ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up Visit|||percentage of correct responses||Standard Error|Mean
1308008|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)|ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up|||dB||Standard Error|Mean
1308197|NCT02653495|Secondary|Antibody Response D90|Measured by hemagglutination inhibition assay|90 days after vaccination compare to day 28|Data were not collected.||||||
1308009|NCT02665455|Primary|Point Accuracy Determined as % Within Consensus Error Grid Zone A|"Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.~Zone A is defined as the zone of “clinical accurate measurements with no effect on clinical action.”"|14 days||||percentage of results||95% Confidence Interval|Number
1308010|NCT02665286|Secondary|Patient Satisfaction With Treatment|The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention.|1 week||||Participants|||Count of Participants
1308011|NCT02665286|Secondary|Medications--Patient Self Report of Medication Use|Participants still using medication such as analgesics for LBP after treatment|1 week||||Participants|||Count of Participants
1308012|NCT02665286|Secondary|Cases of Moderate or Severe LBP|Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none|1 week||||Participants|||Count of Participants
1308013|NCT02665286|Primary|Functional Impairment as Measured on the Roland Morris Disability Questionnaire|"Change in Roland Morris Disability Questionnaire between baseline and 1 week.~The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment."|1 week||||units on a scale||95% Confidence Interval|Mean
1308014|NCT02665260|Secondary|Number of Subjects Who Experienced an Adverse Event|Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit|33 weeks||||Participants|||Count of Participants
1308015|NCT02665260|Primary|Number of Subjects Who Achieve Complete Clearance at 6 Weeks|Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)|6 weeks||||Participants|||Count of Participants
1308016|NCT02665221|Other Pre-specified|Flu-like Symptom Scale at Last Visit Compared to Base Line.|Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.|6 Hours|Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.||||||
1308017|NCT02665221|Secondary|Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.|Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.|6 Hours|Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.||||||
1308018|NCT02665221|Secondary|Width of Injection Site Erythema in Millimeters 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline Width of Injection Site Erythema at Least 2 Hours After Injection.|Study was terminated. No data analyzed|6 Hours|Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.||||||
1308019|NCT02665221|Primary|Patient Erythema Self-Assessment (PSA) Score 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline PSA Score of Injection Site Erythema at Least 2 Hours After PLEGRIDY Injection.||6 Hours|Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.||||||
1308020|NCT02664987|Secondary|Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale|"The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 4:~0- Fully active, able to carry on all pre-disease performance without restriction~Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work~Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours~Capable of only limited self-care, confined to bed or chair more than 50% of waking hours~Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair~A higher score indicates greater functional impairment."|Day 1||||percentage of patients|||Number
1308021|NCT02664987|Secondary|Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient|"Patients answered yes or no to the following question:~Have you had trouble sleeping due to your cancer pain within the last 7 days?"|Past 7 days up to Day 1||||percentage of patients|||Number
1308022|NCT02664987|Primary|Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient|"Patients indicated their pain intensity using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).~Their current pain intensity and pain in the last 24 hours were indicated on separate scales. A higher score indicates higher pain intensity."|Past 1 day up to Day 1||||units on a scale||Standard Deviation|Mean
1308023|NCT02664987|Primary|Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient|EQ-5D-3L summary indices were calculated using the algorithm developed based on the valuation of EQ-5D-3L health states from an adult Thai population (Tongsiri & Cairns, 2011). Applying the Thai algorithm, EQ-5D-3L summary indices range from -0.45 to 0.80, with an EQ-5D-3L summary index of 0.80 indicating the best overall health-related quality of life.|Day 1||||units on a scale||Standard Deviation|Mean
1308024|NCT02664987|Primary|Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators|"The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:~Very satisfied~Satisfied~Acceptable~Dissatisfied~Very dissatisfied~Patients and Investigators will each indicate their opinion on separate scales."|Day 1||||percentage of patients|||Number
1308025|NCT02664987|Primary|Prescription Pattern of Analgesics (Opioid or Non-opioid)|At Visit 1 (Day 1) which was the only visit in the study, data was collected on whether each patient was receiving only opioid, only non-opioid or both opioid and non-opioid analgesic treatments for pain control.|Day 1||||percentage of patients||95% Confidence Interval|Number
1308026|NCT02664610|Secondary|Mean Change in Diastolic Blood Pressure||Baseline to 6 months||||mmHg||Standard Deviation|Mean
1308027|NCT02664610|Primary|Mean Change in Systolic Blood Pressure||Baseline to 6 months||||mmHg||Standard Deviation|Mean
1308028|NCT02664532|Secondary|Total Laryngoscopy Duration in Seconds|The duration of intubation was defined as the time taken from placement of the laryngoscope in the mouth to the time taken to remove the laryngoscope from the mouth following intubation.|180 seconds||||Seconds||Standard Deviation|Mean
1338038|NCT01968135|Secondary|Number of Days Without Bleeding During Therapy||Over the 14 day course of study drug||||days||Full Range|Median
1308029|NCT02664532|Secondary|Number of Intubation Attempts|An intubation attempt is defined as “intubation activities occurring during a single continuous laryngoscopy maneuver”. Thus, even if several attempts were made to place an endotracheal tube during the course of a single laryngoscopy, this would be counted as a single intubation attempt.|180 seconds||||participants|||Number
1308030|NCT02664532|Secondary|Cormack Lehane Grading|Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible|60 seconds||||participants|||Number
1308031|NCT02664532|Primary|Ease of Intubation or Degree of Difficulty With Intubation|Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope|60 seconds||||participants|||Number
1308032|NCT02664311|Secondary|Fluoroscopy Time|Fluoro time as recorded by RNs from Xray machine|Immediate post-procedure||||minutes||Standard Deviation|Mean
1308033|NCT02664311|Secondary|Freedom From AF||1 year||||Participants|||Count of Participants
1308034|NCT02664311|Primary|Isolation Time|Comparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation|Immediate post procedure||||minutes||Standard Deviation|Mean
1308035|NCT02663752|Secondary|Changes in Transferrin Saturation Levels|From baseline to time of response (responder group) or time to last follow up (non-responders)|Baseline, 18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
1308036|NCT02663752|Secondary|Changes in Serum Transferrin Levels|From baseline to time of response (responder group) or time to last follow up (non-responders)|Baseline, 18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
1308037|NCT02663752|Secondary|Deferasirox Dose Used|Deferasirox dose is defined as the average daily dose (mg/kg/d) given to the patient from treatment initiation to the emergence of hematological response in the responder group or the time of enrollment in the study in the non-responder group.|18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
1308038|NCT02663752|Secondary|Changes in Serum Ferritin Levels|From baseline to time of response (responder group) or time to last follow up (non-responders)|Baseline, 18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
1308039|NCT02663752|Secondary|Time to Response|The time to response is defined as the time (in months) between the date of deferasirox initiation and the date of the first documented hematological response only in the responder group.|18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
1308040|NCT02663752|Primary|Fold Increase/Decrease in Gene Transcription From Baseline Bone Marrow Aspirate of Responders Versus Non-responders’|Using next-generation sequencing, gene expression profiling in responder and non-responder patients were to be performed on existing bone marrow aspirate samples. Gene transcription were then to be compared between the two groups and the fold increase/decrease in differentially expressed genes were to be calculated.|18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
1308041|NCT02663453|Secondary|Assessment of Aspartate Aminotransferase (AST)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month||||U/L||Standard Deviation|Mean
1308042|NCT02663453|Secondary|Assessment of Alanine Aminotransferase (ALT)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month||||U/L||Standard Deviation|Mean
1308043|NCT02663453|Secondary|Assessment of Gamma Glutamyltranspeptidase (GGT)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month||||U/L||Standard Deviation|Mean
1308044|NCT02663453|Secondary|Head Circumference Gain|in-hospital head circumference gain at birth until discharge (cm/week)|up to 24 weeks||||cm/week||Standard Deviation|Mean
1308045|NCT02663453|Secondary|Height Gain|in-hospital height gain at birth until discharge (cm/week)|up to 24 weeks||||cm/week||Standard Deviation|Mean
1308046|NCT02663453|Secondary|Weight Gain|in-hospital weight gain at birth until discharge (gram/day)|up to 24 weeks||||gram/day||Standard Deviation|Mean
1308047|NCT02663453|Secondary|Incidence of Extrauterine Growth Restriction (EUGR)|weight that is less than the tenth percentile for corrected gestational age by the time of discharge|up to 24 weeks||||Participants|||Count of Participants
1308048|NCT02663453|Secondary|Neonatal Morbidities|retinopathy of prematurity, bronchopulmonary dysplasia|4 months||||Participants|||Count of Participants
1308049|NCT02663453|Primary|Incidence of Neonatal Cholestasis|direct bilirubin level of more than 2 mg/dL|3 months||||Participants|||Count of Participants
1308050|NCT02663232|Secondary|Percentage of Participants With Adequate Quality/Quantity of Tumor Sample||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308051|NCT02663232|Secondary|Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique|The samples were classified based on the percentage of tumor cells referred to the technique as follows: <60 percent (%), 60-80%, >80% and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308052|NCT02663232|Secondary|Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308055|NCT02663232|Secondary|Percentage of Participants With Regression|Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308056|NCT02663232|Secondary|Percentage of Participants With Ulceration||Day 1|All participants enrolled in the study were included in the analysis|||percentage of participants|||Number
1308057|NCT02663232|Secondary|Percentage of Participants Categorized by Breslow Thickness|Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308058|NCT02663232|Secondary|Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308059|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308060|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308061|NCT02663232|Secondary|Median Time Since Diagnosis of Melanoma|Median time from the diagnosis of primary melanoma to advanced disease was determined in years.|Day 1|All participants enrolled in the study were included in the analysis except for one participant with missing data.|||years||Full Range|Median
1308062|NCT02663232|Secondary|Percentage of Participants Categorized By LDH Level|Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308063|NCT02663232|Secondary|Percentage of Participants Categorized by Primary Tumor Location|Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308064|NCT02663232|Secondary|Percentage of Participants With Sun Exposure|Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308065|NCT02663232|Secondary|Percentage of Participants With Family History of Melanoma||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308066|NCT02663232|Secondary|Percentage of Participants Categorized by Melanoma Stage|Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
1308067|NCT02663232|Primary|Percentage of Participants With V600 BRAF Mutation Status|Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.|Day 1|All enrolled participants were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1308068|NCT02662764|Primary|Total Amount of Supplemental Morphine (mg) Utilized|Supplemental opioid medication (2 mg IV morphine) was allowed in the first 30 minutes after the first on-demand dose of study drug had been administered, if necessary, to keep a patient comfortable. Otherwise, supplemental opioid medication (2 mg IV morphine, no more frequently than hourly) was allowed for pain due to ambulation or with the initiation of passive range of motion therapy throughout the remainder of the study.|Up to 72 hours|Amount of supplemental morphine (mg) utilized by patients|||amount of morphine (mg) used||Standard Deviation|Mean
1308069|NCT02662764|Primary|Average Inter-dosing Interval (in Minutes)||Up to 72 hours||||average interval (minutes) between doses||Standard Deviation|Mean
1308070|NCT02662764|Primary|Average Hourly Use of Study Drug|Average number of study drug doses used per hour, adjusting by treatment exposure time and study period|Up to 72 hours||||average number of study doses per hour||Standard Deviation|Mean
1308071|NCT02662764|Primary|Number of Study Drug Doses Used||Up to 72 hours||||doses||Standard Deviation|Mean
1308072|NCT02662764|Primary|Nurse Usability Questionnaire (NUQ)|Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients|Up to 72 hours||||percentage of HCPs|||Number
1308073|NCT02662764|Primary|Patient Usability Questionnaire (PUQ)|Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.|Up to 72 hours||||percentage of patients|||Number
1308074|NCT02662764|Primary|Pain Relief (PR) at Each Evaluation Time Point|At protocol-specified time points, the patient is asked to self-record his/her current level of pain relief on 5-point numerical rating scale where 0 equaled no pain relief and 4 equaled complete pain relief. The baseline score references the baseline pain intensity score and the following timepoints reference pain relief scores.|Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||units on a scale||Standard Error|Mean
1308075|NCT02662764|Primary|Pain Intensity Difference (PID) at Each Evaluation Time Point|The PID at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. The higher the PID score, the lower the pain intensity. The scores ranged from - 239 to 624.|Up to 72 hours||||units on a scale||Standard Error|Mean
1308076|NCT02662764|Primary|Pain Intensity (PI) at Each Evaluation Time Point|At protocol-specified time points, the patient is asked to self-record his/her current level of pain on an 11-point numerical rating scale where 0 equals no pain and 10 equals the worst possible pain.|Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||units on a scale||Standard Error|Mean
1308077|NCT02662764|Primary|Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72)|Total pain relief over the 72-hour study period. A higher TOTPAR means a greater relief in pain. Range of scores was from 0.00 to 288.00.|Up to 72 hours||||units on a scale||Standard Error|Mean
1308078|NCT02662764|Primary|Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48)|Total pain relief over the 48-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 192.00.|Up to 48 hours||||units on a scale||Standard Error|Mean
1308079|NCT02662764|Primary|Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24)|Total pain relief over the 24-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 96.00.|Up to 24 hours||||units on a scale||Standard Error|Mean
1308080|NCT02662764|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 72 hour period. The time-weighted SPID72 is the time-weighted summed PID over the 72-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. The scores ranged from -239 to 624.|Up to 72 hours||||units on a scale||Standard Error|Mean
1308081|NCT02662764|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points and throughout the 48 hour period. The time-weighted SPID48 is the time-weighted summed PID over the 48-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from -144 to 408.|Up to 48 hours||||units on a scale||Standard Error|Mean
1308082|NCT02662764|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 24 hour period. The time-weighted SPID24 is the time-weighted summed PID over the 24-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from - 72 to 204.|Up to 24 hours||||units on a scale||Standard Error|Mean
1308083|NCT02662764|Primary|Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period||Up to 72 hours||||percentage of patients|||Number
1308084|NCT02662764|Primary|Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia After the 24-hour Study Period and Prior to or During the 48 Hour Study Period||Up to 48 hours||||percentage of patients|||Number
1308085|NCT02662764|Primary|Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period||Up to 24 hours||||percentage of patients|||Number
1308086|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Excellent"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308087|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Good"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308088|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Fair"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308089|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Poor"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308090|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as Excellent"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308091|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as Good"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1312121|NCT02517021|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase||0-24 hours||||Participants|||Count of Participants
1308092|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as Fair"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308093|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as Poor"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308094|NCT02662764|Primary|"Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Excellent at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308095|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Good at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308096|NCT02662764|Primary|"Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Fair at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308097|NCT02662764|Primary|"Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Poor at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308098|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 72 Hours as Good or Excellent"||Up to 72 hours|Overall number of HCPs who completed the assessment. In rare cases, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308099|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Rate the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 48 Hours as Good or Excellent"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308100|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 24 Hours as Good or Excellent"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
1308101|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Excellent"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308102|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Good"||Up to 72 hours|This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308103|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Fair"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308104|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Poor"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308105|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Excellent"||Up to 48 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308106|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Good"||Up to 48 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308107|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Fair"||Up to 48 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308108|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Poor"||Up to 48 hours|This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308109|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Excellent at 24 Hours"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308110|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Good at 24 Hours"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308111|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Fair at 24 Hours"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308112|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Poor at 24 Hours"||Up to 24 hours|This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308113|NCT02662764|Primary|"Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as Good or Excellent"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308114|NCT02662764|Primary|"Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as Good or Excellent"||Up to 48 hours|This assessment completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308115|NCT02662764|Primary|"Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as Good or Excellent"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
1308116|NCT02662764|Primary|Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap||Up to 72 hours||||percentage of participants|||Number
1308117|NCT02662764|Primary|Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System||Up to 72 hours||||percentage of patients|||Number
1308118|NCT02662764|Primary|Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing||Up to 72 hours||||Notifications|||Number
1308119|NCT02662764|Primary|Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)||Up to 72 hours||||percentage of patients|||Number
1308120|NCT02662764|Primary|Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)||Up to 24 hours||||tablets|||Number
1308121|NCT02662764|Primary|Percentage of Patients With Misplaced Tablet(s)||Up to 72 hours||||percentage of patients|||Number
1308122|NCT02662764|Primary|Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout||Up to 72 hours||||percentage of patients|||Number
1308123|NCT02662764|Primary|Percentage of Patients, if Any, With Tablets Dispensed But Not Requested||Up to 72 hours||||percentage of patients|||Number
1308124|NCT02662764|Primary|Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System||Up to 72 hours||||percentage of patients|||Number
1308125|NCT02662608|Primary|Number of Participants With Disease Progression|Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|6 weeks||||Participants|||Count of Participants
1308126|NCT02662556|Secondary|Percentage of Healthcare Professionals Who Responded to the Global Assessments as “Excellent” or “Good”|"Healthcare professionals were asked “Overall, how would you rate the method of pain control? Poor (1) Fair (2) Good (3) Excellent (4)"|12 hours or until patients' termination from study||||percentage of healthcare professionals||95% Confidence Interval|Number
1308127|NCT02662556|Secondary|Percentage of Patients Who Responded to the Global Assessments as “Excellent” or “Good”|"Patients were asked “Overall, how would you rate the method of pain control? Poor (1), Fair (2), Good (3), or Excellent (4)"|12 hours or at patients' termination from study|135 patients completed the scale|||percentage of subjects||95% Confidence Interval|Number
1308128|NCT02662556|Secondary|Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|1 hours||||units on a scale||Standard Error|Mean
1308129|NCT02662556|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|12-hours||||units on a scale||Standard Error|Mean
1308130|NCT02662387|Secondary|Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU|Actual length of stay in pediatric ICU from admission to discharge|From subject enrollment to hospital discharge, not >170 hr||||hours||Full Range|Median
1308131|NCT02662387|Primary|Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone|Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status)|Change from baseline to time of hospital discharge, no greater than 1 month||||number/score||Full Range|Mean
1308132|NCT02661594|Primary|Maximal Mean Change in QTcF From Average Baseline||24 hours||||milliseconds||90% Confidence Interval|Mean
1308133|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time > 250 mg/dL|Comparison of percentage of time > 250 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
1308134|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time > 180 mg/dL|Comparison of percentage of time > 180 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
1308135|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time in Range (70-180 mg/dL)|Comparison of percentage of time in range (70-180 mg/dL) from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
1308136|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time < 70 mg/dL|Comparison of percentage of time < 70 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
1308137|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time < 54 mg/dL|Comparison of percentage of time < 54 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
1308138|NCT02660242|Secondary|CGM Metrics During Late Recovery - Coefficient of Variation|Comparison of the coefficient of variation from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Inter-Quartile Range|Median
1308139|NCT02660242|Secondary|CGM Metrics During Late Recovery - Mean Glucose|Comparison of mean glucose from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data.|||mg/dL||Inter-Quartile Range|Median
1308140|NCT02660242|Secondary|CGM Metrics During Late Recovery - Peak Glucose|Comparison of peak glucose from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data.|||mg/dL||Inter-Quartile Range|Median
1308141|NCT02660242|Secondary|Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose|Comparison of nadir glucose from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data.|||mg/dL||Inter-Quartile Range|Median
1308142|NCT02660242|Secondary|Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery|Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.|0 to 75 minutes following exercise initiation||||Participants|||Count of Participants
1308143|NCT02660242|Secondary|Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery|Comparison of occurrence of hypoglycemia (<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.|0 to 75 minutes following exercise initiation||||Participants|||Count of Participants
1308144|NCT02660242|Primary|Glycemic Response During Exercise and Early Recovery|Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.|0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)||||mg/dL||Standard Deviation|Mean
1308145|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
1308146|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
1308147|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
1308148|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion: All observations of an episode of care with trastuzumab IV infusion that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
1308149|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab SC Injection: All observations of an episode of care with trastuzumab SC injection that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
1308150|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab Single-Use Injection Device: All observations of an episode of care with trastuzumab single-use injection device that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
1308151|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
1308152|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
1308153|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
1308154|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
1308155|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
1308156|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
1308157|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
1308158|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
1308159|NCT02658461|Secondary|Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample|||pounds|Participants|Standard Deviation|Mean
1308160|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample|||pounds|Participants|Standard Deviation|Mean
1308198|NCT02653495|Secondary|Gene Expression Profiling D90|Analyze by RNA-seq|90 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.||||||
1308161|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample: All observations of an episode of care for the given treatment route.|||pounds|Participants|Standard Deviation|Mean
1308162|NCT02658149|Secondary|Opioid Usage In-hospital at 48 Hours|Total amount of opioids used per patient (measured with Morphine Equivalent Units)|48 hours postoperatively||||Morphine Equivalent Units (Oral)||Standard Deviation|Mean
1308163|NCT02658149|Secondary|Opioid Usage In-hospital at 24 Hours|Total amount of opioids used per patient (measured with Morphine Equivalent Units)|24 hours postoperatively||||Morphine Equivalent Units (Oral)||Standard Deviation|Mean
1308164|NCT02658149|Secondary|Pain Score at 24-48 Hours|Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|measured once during time froma 24-48 hours postoperative||||units on a scale||Standard Deviation|Mean
1308165|NCT02658149|Secondary|Pain Score at 3-24 Hours|Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|measured once during time frame 3 hours-24 hours postoperative||||units on a scale||Standard Deviation|Mean
1308166|NCT02658149|Primary|Pain Score at 3 Hours|Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|3 hours postoperative||||units on a scale||Standard Deviation|Mean
1308167|NCT02657629|Primary|Weight Gain in Grams Per Day||Daily until hospital discharge (up to maximum of 3 months of age)||||grams/day||Standard Deviation|Mean
1308168|NCT02657538|Secondary|Lesion Activity|active lesions: 1; inactive lesions: 0|One year|The data were not collected and the Outcome will never be analyzed because of the study population. The participants are all low risk in the analysis of caries, with low amount of gingivitis and good oral hygiene what means that no progression/ change in caries activity will be detectable in any patient. So it doesn't make sense to analyze it.||||||
1308169|NCT02657538|Primary|Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)|"The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine~Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions.~Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them"|One year||||weighted Kappa|Participants|95% Confidence Interval|Mean
1308170|NCT02657252|Secondary|Number of Participants With Deep Venous Thrombosis (DVT)|Observe after one week of treatment occurred if clinical signs and symptoms of deep vein thrombosis (DVT) and perform duplex ultrasound for confirmation. Compare the results between the two groups to establish a security policy.|1 week||||Participants|||Count of Participants
1308171|NCT02657252|Secondary|Skin Hyperpigmentation|Observed after two months of treatment the occurrence of hyperpigmentation stains in the treated areas. Measuring in centimeters those stains and compare the two treatments together.|2 months||||percentage of hyperpigmentation||95% Confidence Interval|Median
1308172|NCT02657252|Primary|Change From Baseline in Extent of Telangiectasias|Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments|2 months|Only one lower limb submited to the treatment.|||percent of change negative values||Standard Deviation|Mean
1308173|NCT02657031|Secondary|The Number of Patients Experiencing Restlessness|Yes/No|0-60 minutes||||participants|||Number
1308174|NCT02657031|Secondary|The Number of Participants Experiencing Vomiting|Yes/No|0-60 minutes||||participants|||Number
1308175|NCT02657031|Secondary|Nausea|Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum nausea. A change of 0 mm corresponds to no change in nausea level, and a negative value indicates worsening of the nausea after the medication.|0-60 minutes||||mm||Standard Deviation|Mean
1308176|NCT02657031|Secondary|Anxiety|Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum anxiety. A change of 0 mm corresponds to no change in anxiety level, and a negative value indicates worsening of the anxiety after the medication.|0-60 minutes||||mm||Standard Deviation|Mean
1308177|NCT02657031|Primary|Headache Following Intervention|Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.|0-60 minutes||||mm||95% Confidence Interval|Mean
1308178|NCT02656485|Secondary|Efficacy|Absolute Change from Baseline in Total Number of Lesions|Baseline and 4 weeks|All efficacy and safety data were analyzed using the ITT/Safety population.|||Lesions||Standard Deviation|Mean
1308179|NCT02656485|Primary|Safety (Number of Participants With Treatment Related Adverse Events)|Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses|4 weeks|The safety analysis set included all subjects in the ITT/Safety population.|||Participants|||Count of Participants
1308180|NCT02656160|Secondary|Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O)|Effect of dalfampridine on genioglossus muscle responsiveness to increased epiglottic pressure swings during sleep in healthy controls during NREM sleep. The variation of EMG GG is expressed here as % of maximal activation.|1 night||||%max/cmH2O||Inter-Quartile Range|Median
1308181|NCT02656160|Primary|Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration).|The EMG GG was quantified in arbitrary units derived from signal processing of the raw signal and as a percentage of wakefulness (%wake) for between-nights comparison of baseline sleep EMG GG activity. EMG GG analysis was performed on a breath-by-breath basis to identify a maximum value and a minimum value during inspiration and expiration, respectively (EMG GG peak and tonic). The difference between peak and tonic values was used to estimate respiratory related phasic activity. Wakefulness EMG GG values were obtained from a minimum of 10 epochs (30 s each) with the subject lying in the lateral position. Criteria for breath selection during wakefulness were (1) stable breathing (constant epiglottic pressure swings) and (2) absence of movement artifacts (i.e., swallowing, speech, yawns).|1 night||||percentage of wakefulness value||Inter-Quartile Range|Median
1308182|NCT02654639|Primary|Length of Progression-Free Survival|Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.|From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.|The study was terminated early due to recruitment difficulties. 4 subjects were enrolled but no outcomes data was collected and no analysis was performed.||||||
1308183|NCT02654145|Secondary|Ratio to Baseline in Blood Eosinophil Count at Week 32|Blood samples were collected at specific time points to measure blood eosinophils level for evaluation of pharmacodynamic effects in participants with a severe eosinophilic asthma phenotype when they were directly switched to mepolizumab. Baseline was defined as the latest available assessment prior to first dose of mepolizumab and ratio to Baseline at Week 32 was defined as Week 32 value divided by Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, Baseline maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable) and visit. The log transformation was applied to blood eosinophil counts prior to analysis. If a blood eosinophil count of zero was reported, it was imputed with half of the lowest possible blood eosinophil count, where applicable, prior to log transforming the data. The dispersion measure used was log standard error.|Baseline and at Week 32|Intent to treat- all participants who received at least one dose of mepolizumab|||Ratio||Standard Error|Least Squares Mean
1308184|NCT02654145|Secondary|The Rate of Clinically Significant Asthma Exacerbations Over 32 Weeks’ Treatment|Clinically significant exacerbations of asthma were defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visits. The frequency of clinically significant asthma exacerbations over 32 weeks’ treatment was analyzed using Negative Binomial Regression via generalized estimating equations with a covariate of time period (pre-treatment versus on- and off treatment).|Up to Week 32|Intent to treat - all participants who received at least one dose of mepolizumab|||Exacerbation rate per year|||Number
1308185|NCT02654145|Secondary|Mean Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Score at Week 32|The SGRQ Questionnaire is a well-established, self-completed tool, comprising of 50 questions with 76 weighted responses designed to measure Quality of Life in participants with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptom score and Part 2 produces the activity and impact score. A Total score is also calculated which summarizes the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and zero indicates best possible health status. Baseline was defined as the latest available assessment prior to first dose of mepolizumab. Change from Baseline at Week 32 was calculated as Week 32 value of SGRQ score minus Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and visit.|Baseline and at Week 32|Intent to treat - all participants who received at least one dose of mepolizumab|||Scores on a scale||Standard Error|Least Squares Mean
1308186|NCT02654145|Primary|Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 32|The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition. Baseline was defined as the latest available assessment prior to first dose of mepolizumab. Change from Baseline at Week 32 was calculated as Week 32 value of ACQ-5 score minus Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, baseline maintenance OCS therapy, exacerbations in the year prior to the study (as ordinal variable) and visit.|Baseline and at Week 32|Intent to treat - all participants who received at least one dose of mepolizumab|||Scores on a scale||Standard Error|Least Squares Mean
1308187|NCT02653872|Primary|Assessment of the Tmax of Verapamil, Itraconazole and OH-itraconazole Following Co-administration of AZD7986 With Verapamil or Itraconazole.|To assess the time to reach maximum observed concentration of Verapamil, Itraconazole and OH-itraconazole (a metabolite of itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||hours||Full Range|Median
1308199|NCT02653495|Secondary|Gene Expression Profiling D28|Analyze by RNA-seq|28 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.||||||
1308200|NCT02653495|Secondary|Gene Expression Profiling D1|Analyze by RNA-seq|1 day post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.||||||
1308201|NCT02653495|Primary|Antibody Response D28|Measured by hemagglutination inhibition assay|28 days after vaccination compare to baseline (screening visit 1) pre-vaccination|Data were not collected||||||
1312715|NCT02500368|Secondary|Lens Tightness|Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.|Baseline and 1 week||||percentage of tightness||Standard Deviation|Mean
1308188|NCT02653872|Primary|Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC [0 - τ]) of Verapamil, Itraconazole and OH-itraconazole Following Co-administration of AZD7986 With Verapamil or Itraconazole.|To assess the area under the plasma concentration-time curve from time over the dosing interval tau (24 hours) of Verapamil, itraconazole and OH-itraconazole (a metabolite of Itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1308189|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||Litres||Standard Deviation|Mean
1308190|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Standard Deviation|Mean
1308191|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Time to Reach Maximum Plasma Concentration (Tmax)|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||hours||Full Range|Median
1308192|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||hours||Standard Deviation|Mean
1308193|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-t]).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1308194|NCT02653872|Primary|Effect of Verapamil and the Effect of Itraconazole on the PK of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC).|To assess the effect of verapamil and itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1308195|NCT02653872|Primary|Effect of Verapamil and the Effect of Itraconazole on the PK of AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1308196|NCT02653560|Primary|24-hour Average Systolic Blood Pressure|Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.|4 weeks||||mmHg||Standard Deviation|Mean
1308202|NCT02652221|Primary|Agreement in Measured Liver Stiffness Between ARFI and MRE|The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis|Within 24 hours||||Correlation Coefficient (rho)|||Number
1308203|NCT02652221|Primary|Agreement in Measured Liver Stiffness Between ARFI and MRE|The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis|Within 24 hours||||kPa|||Number
1308204|NCT02652208|Secondary|Satisfaction With the Intervention|"Number of respondents who rated the material as very good or excellent."|Within 1 week after reviewing the decision aid|All participants who completed and returned a survey within the 6 month study period.|||Participants|||Count of Participants
1308205|NCT02652208|Secondary|Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)|To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort.|Within 1 week after reviewing the decision aid|Only participants who indicated they currently had symptoms were asked to complete the item|||Participants|||Count of Participants
1308206|NCT02652208|Primary|Total Knowledge Score|Six multiple choice knowledge items covered important facts patients should know about chest pain or discomfort and treatments. A total knowledge score (0-6) was created by summing the total number of correct responses. A missing knowledge response was marked as incorrect. Any survey with more than three missing knowledge responses did not get a total knowledge score. A higher score indicates higher knowledge on the topic. Both decision aids provided information for answering all knowledge items. Higher knowledge scores are better.|Within 1 week after reviewing the decision aid|All participants who completed and returned a survey within the 6 month study period.|||knowledge score||Standard Deviation|Mean
1308207|NCT02651922|Secondary|Tolerability Assess Using a 5 Point Scale|Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)|Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)||||participants|||Number
1308208|NCT02651922|Secondary|Change of EQ-5D VAS Scores (Pre - Post)|VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)||||participants|||Number
1308209|NCT02651922|Secondary|Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)|EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).|Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)||||participants|||Number
1308210|NCT02651922|Secondary|Change of RS-13 (Resilience Questionnaire) (Pre - Post)|RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)||||participants|||Number
1308211|NCT02651922|Secondary|Change of BDEPQ (Benzodiazepine Dependence Questionnaire)|"The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month.~BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence)."|Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)|"For patient with less than 75% items answered the BDEPQ-Score was not calculated.~For only 132 patients Score was calculated."|||participants|||Number
1308212|NCT02651922|Secondary|Change of Symptom Palpation (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 130 patients showed this symptom."|||participants|||Number
1308213|NCT02651922|Secondary|Change of Symptom Trembling (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 108 patients showed this symptom."|||participants|||Number
1308214|NCT02651922|Secondary|Change of Symptom Nausea (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 92 patients showed this symptom."|||participants|||Number
1308215|NCT02651922|Secondary|Change of Symptom Transpiration (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 121 patients showed this symptom."|||participants|||Number
1308216|NCT02651922|Secondary|Change of Symptom Lack of Concentration (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 142 patients showed this symptom."|||participants|||Number
1308665|NCT02638493|Primary|Semen Clearance (CL) of Emtricitabine|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||L/hr||Inter-Quartile Range|Median
1308217|NCT02651922|Secondary|Change of Symptom Fear (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 133 patients showed this symptom."|||participants|||Number
1308218|NCT02651922|Secondary|Change of Symptom Exhaustion (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 145 patients showed this symptom."|||participants|||Number
1308219|NCT02651922|Secondary|Change of Symptom Sleep Disturbance (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 146 patients showed this symptom."|||participants|||Number
1308220|NCT02651922|Primary|Change of Symptom Inner Restlessness (Pre - Post)|Symptom was assessed in a Likert scale ranging from 0 “no symptoms at all” to 10 “very severe symptoms”|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 146 patients showed this symptom."|||participants|||Number
1308221|NCT02651467|Secondary|Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”).|Baseline, Week 4 and 8|"Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.~Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment."|||Score on a scale||Standard Deviation|Mean
1308222|NCT02651467|Secondary|Change From Baseline in Tactile Threshold at Week 4 and 8|Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth.|Baseline, Week 4 and 8|"Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.~Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment."|||grams||Standard Deviation|Mean
1308223|NCT02651467|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 4|Schiff sensitivity score was assessed as participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 4|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Deviation|Mean
1308224|NCT02651467|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)|Schiff sensitivity score was assessed by participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 8|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Data shown for Treatment 1& 2 only for this endpoint. Baseline data only includes those participants who have a corresponding post-baseline assessment.|||Score on a scale||Standard Deviation|Mean
1308225|NCT02651467|Primary|Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)|Schiff sensitivity score was assessed by participant’s response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 8|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. This analysis was conducted on ITT population. Baseline data only includes those participants who have a corresponding post-baseline assessment.|||Score on scale||Standard Deviation|Mean
1308226|NCT02651194|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1308804|NCT02634580|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308227|NCT02651194|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1308228|NCT02651194|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1308229|NCT02651155|Secondary|Weekly Abdominal Symptoms Score|The abdominal symptoms (bloating and discomfort upon waking in the morning) were scored weekly on a 5-point scale, where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded by the participant in the diary.|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a sclae||Standard Deviation|Mean
1308230|NCT02651155|Secondary|Mean Degree Stool Consistency Score|For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a visual medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid).|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a scale||Standard Deviation|Mean
1308231|NCT02651155|Secondary|Mean Degree of Straining Score|For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining is scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining.|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a scale||Standard Deviation|Mean
1308232|NCT02651155|Secondary|Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication|A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who had a SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary.|Up to 24 hours after the first dose of study medication|FAS included all participants who were randomized to receive study treatment whether or not they received treatment.|||percentage of participants|||Number
1308233|NCT02651155|Secondary|SBM Frequency at Weeks 2, 3 and 4|A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.|Weeks 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||SBMs/week||Standard Deviation|Mean
1308234|NCT02651155|Primary|Spontaneous Bowel Movement (SBM) Frequency at Week 1|A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.|Week 1|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by last observation carried forward (LOCF) method.|||SBMs/week||Standard Deviation|Mean
1308235|NCT02650440|Secondary|Berg Scale|Berg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance. The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points. A score below 45 is considered a fall risk. This study comparede the change in the balance control applied scale after intervention as compared to baseline.|Baseline and 6 weeks||||units on a scale||Standard Error|Mean
1308236|NCT02650440|Secondary|Lower Limbs Fugl-Meyer|"The Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment.~This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline"|Baseline and 6 weeks||||units on a scale||Standard Error|Mean
1308237|NCT02650440|Secondary|Ten-meters Walking Test (10MWT)|Change in the time of the gait applied test after intervention as compared to baseline|Baseline and 6 weeks||||seconds||Standard Error|Mean
1308238|NCT02650440|Secondary|Time Up and Go (TUG)|This test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return. This study compared the change in the time of the gait applied test after intervention as compared to baseline.|Baseline and 6 weeks||||seconds||Standard Error|Mean
1308239|NCT02650440|Secondary|Six-minute Walking Test (6MWT)|Change in distance of the gait applied test after intervention as compared to baseline|Baseline and 6 weeks||||meters||Standard Error|Mean
1308666|NCT02638493|Primary|Semen Clearance (CL) of Tenofovir|Samples will be analyzed for drug concentrations at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||L/hr||Inter-Quartile Range|Median
1308240|NCT02650440|Primary|Functional Ambulation Scale (FAC)|"The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently.~This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline."|Baseline and 6 weeks||||units on a scale||Inter-Quartile Range|Median
1308241|NCT02650219|Secondary|Number of Patients With : Antinuclear and/or Anti-SSa and/or Anti-SSb and/or Anti-RNP and/or Anti-DNA and/or Anti-Sm and/or Anticardiolipid and/or Anti β2Gp1 and/or Antiganglioside Autoantibodies (Genetics Analyses From Blood Samples)|data available from biological analyses (blood samples)|baseline|antinuclear autoantibodies|||participants|||Number
1308242|NCT02650219|Secondary|Number of Patients With : Photosensitivity and/or Raynaud Phenomenon and/or Sicca Syndrome and/or Arthralgia and/or Arthritis and/or Thrombosis (Medical History and Questionnaire)|Features usually associated with auto immune disease- data available from medical record of the patients|Baseline|||||||
1308243|NCT02650219|Secondary|Number of Patients With : Splenectomy and/or Bone Events and/or Pulmonary Hypertension and/or Specific Treatment and Non-specific (Medical History,Physiological Parameters and Questionnaire)|data available from medical record of the patients|Baseline|splenectomy testing|||participants|||Number
1308244|NCT02650219|Primary|Number of Patients With GD Diagnosis Confirmed by : Enzyme Testing of acidβ-glucosidase Activity Activity <15% in Blood Leucocytes Completed When Necsssary by GB1 Mutation Analyses (Analyses From Samples)|"acidβ-glucosidase enzyme testing : a lower than 15% of mean normal activity is considered to be diagnostic.~Decreased enzyme levels will often be confirmed by genetic testing. Numerous different mutations occur; GB1 mutation analyses is sometimes necessary to confirm the diagnosis."|baseline||||participant|||Number
1308245|NCT02649634|Secondary|Confidence for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12|"Self-report ratings of confidence for change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how confident they feel about succeeding with losing weight on a scale from 0 “not confident” to 10 was “very confident”. Thus lower scores reflect lower levels of confidence for change, and higher scores reflect higher levels of confidence for change. Their raw score from 0 to 10 on this measure was taken as their Confidence for Change rating score."|Confidence for change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||scores on a scale||Standard Deviation|Mean
1308246|NCT02649634|Secondary|Readiness for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12|"Self-report ratings of readiness for change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how ready they are to lose weight on a scale from 0 “not ready” to 10 was “very ready”. Thus lower scores reflect lower levels of readiness for change, and higher scores reflect higher levels of readiness for change. Their raw score from 0 to 10 on this measure was taken as their Readiness for Change rating score."|Readiness for change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||scores on a scale||Standard Deviation|Mean
1308247|NCT02649634|Secondary|Importance for Change Ratings After the Second Motivational Interview or Attention Control Interview, Week 12|"Self-report ratings of importance of change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how important it is for them personally to lose weight on a scale from 0 “not important” to 10 was “very important”. Thus lower scores reflect lower levels of importance for change, and higher scores reflect higher levels of importance for change. Their raw score from 0 to 10 on this measure was taken as their Importance for Change rating score."|Importance of change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||scores on a scale||Standard Deviation|Mean
1308248|NCT02649634|Secondary|Confidence for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1- 2|"Self-report ratings of confidence for change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how confident they feel about succeeding with losing weight on a scale from 0 “not confident” to 10 was “very confident”. Thus lower scores reflect lower levels of confidence for change, and higher scores reflect higher levels of confidence for change. Their raw score from 0 to 10 on this measure was taken as their Confidence for Change rating score."|Confidence for change ratings measured immediately after the first MI or attention control interview (week 1- 2)||||scores on a scale||Standard Deviation|Mean
1308249|NCT02649634|Secondary|Readiness for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 -2|"Self-report ratings of readiness for change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how ready they are to lose weight on a scale from 0 “not ready” to 10 was “very ready”. Thus lower scores reflect lower levels of readiness for change, and higher scores reflect higher levels of readiness for change. Their raw score from 0 to 10 on this measure was taken as their Readiness for Change rating score."|Readiness for change ratings measured immediately after the first MI or attention control interview (week 1- 2)||||scores on a scale||Standard Deviation|Mean
1308250|NCT02649634|Secondary|Importance of Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 - 2|"Self-report ratings of importance of change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how important it is for them personally to lose weight on a scale from 0 “not important” to 10 was “very important”. Thus lower scores reflect lower levels of importance for change, and higher scores reflect higher levels of importance for change. Their raw score from 0 to 10 on this measure was taken as their Importance for Change rating score."|Importance of change ratings measured immediately after the first MI or attention control interview (week 1- 2)||||scores on a scale||Standard Deviation|Mean
1308251|NCT02649634|Secondary|Self-efficacy for Engaging in Physical Activity After the Second Motivational Interviewing or Attention Control Interview, Week 12|Self-efficacy for engaging in physical activity was measured by the Exercise Self-Efficacy questionnaire (ESE; Nigg & Riebe, 2002). Participants rate their confidence that they could exercise on a 5-point Likert scale for six barriers to exercise (e.g., bad weather, stress, availability of equipment). Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean self-efficacy for engaging in physical activity measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||ESE score||Standard Deviation|Mean
1308252|NCT02649634|Secondary|Self-efficacy Related to Eating Patterns After the Second Motivational Interviewing or Attention Control Interview, Week 12|Self-efficacy related to eating patterns was measured by the Weight Efficacy Life-Style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991). This self-report questionnaire yields five subscale scores, which rate self-efficacy for controlling eating in different situations/dimensions: negative emotions, availability, social pressure, physical discomfort, and positive activities. A global/total score (which ranges from 0 - 180) is obtained by summing the scores of each of the five subscales. Higher scores are indicative of greater self-efficacy (i.e., higher scores = better outcome).|Mean self-efficacy related to eating patterns measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global score on WEL||Standard Deviation|Mean
1308253|NCT02649634|Secondary|Self-efficacy for Engaging in Physical Activity After the First Motivational Interviewing or Attention Control Interview, Week 1- 2|Self-efficacy for engaging in physical activity was measured by the Exercise Self-Efficacy questionnaire (ESE; Nigg & Riebe, 2002). Participants rate their confidence that they could exercise on a 5-point Likert scale for six barriers to exercise (e.g., bad weather, stress, availability of equipment). Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean self-efficacy for engaging in physical activity measured immediately after the first MI or attention control interview (week 1 - 2)||||ESE score||Standard Deviation|Mean
1308254|NCT02649634|Secondary|Self-efficacy Related to Eating Patterns After the First Motivational Interviewing or Attention Control Interview, Week 1 - 2|Self-efficacy related to eating patterns was measured by the Weight Efficacy Life-Style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991). This self-report questionnaire yields five subscale scores, which rate self-efficacy for controlling eating in different situations/dimensions: negative emotions, availability, social pressure, physical discomfort, and positive activities. A global/total score (which ranges from 0 - 180) is obtained by summing the scores of each of the five subscales. Higher scores are indicative of greater self-efficacy (i.e., higher scores = better outcome).|Mean self-efficacy related to eating patterns measured immediately after the first MI or attention control interview (week 1 to 2)||||Global score on WEL||Standard Deviation|Mean
1308255|NCT02649634|Secondary|Eating Disorder Symptomology at 6 Month Follow up|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global EDE-Q score||Standard Error|Mean
1308256|NCT02649634|Secondary|Eating Disorder Symptomology at 1 Month Follow up|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global EDE-Q score||Standard Error|Mean
1308257|NCT02649634|Secondary|Eating Disorder Symptomology at End of the Behavioural Weight Loss Program, Week 12|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global EDE-Q score||Standard Error|Mean
1308258|NCT02649634|Secondary|Blood Pressure at 6 Month Follow up|A measure of systolic and diastolic blood pressure was taken in a standardized manner according to the Canadian Hypertension Education Program Guidelines (Hemmelgarn et al., 2006). Three different readings of blood pressure were taken at each time point (baseline and 6 month follow up), and the average of the three readings was taken as the measure of blood pressure for each time point.|Mean blood pressure 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||mmHg||Standard Error|Mean
1308259|NCT02649634|Secondary|Blood Pressure at End of the Behavioural Weight Loss Program, Week 12|A measure of systolic and diastolic blood pressure was taken in a standardized manner according to the Canadian Hypertension Education Program Guidelines (Hemmelgarn et al., 2006). Three different readings of blood pressure were taken at each time point (baseline and end of behavioural weight loss program), and the average of the three readings was taken as the measure of blood pressure for each time point.|Mean blood pressure at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||mmHg||Standard Error|Mean
1308260|NCT02649634|Secondary|Dietary Behaviour at 6 Month Follow up|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Overall score on DHQ||Standard Error|Mean
1308261|NCT02649634|Secondary|Dietary Behaviour at 1 Month Follow up|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Overall score on DHQ||Standard Error|Mean
1308262|NCT02649634|Secondary|Dietary Behaviour at End of the Behavioural Weight Loss Program, Week 12|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||overall score on DHQ||Standard Error|Mean
1308272|NCT02648438|Secondary|Oral Bioavailability After Inhaled Treatment (F Oral)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1308263|NCT02649634|Secondary|Physical Activity at 6 Month Follow up|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilocalories per week||Standard Error|Mean
1308264|NCT02649634|Secondary|Physical Activity at 1 Month Follow up|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilocalories per week||Standard Error|Mean
1308265|NCT02649634|Secondary|Physical Activity at End of the Behavioural Weight Loss Program, Week 12|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilocalories per week||Standard Error|Mean
1308266|NCT02649634|Secondary|BMI at 6 Month Follow up|A digital scale (Tanita BWB-800S), which assessed weight to the nearest 0.1 kg, was used to assess weight for the 6 month follow up assessment, and the height measured at the beginning of the behavioural weight loss program was used to calculate BMI. BMI was calculated as weight in Kilograms divided by height in meter squared.|Mean BMI 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kg/m2||Standard Error|Mean
1308267|NCT02649634|Secondary|BMI at End of Behavioural Weight Loss Program, Week 12|Weight was measured to the nearest 0.1 kg using a balance beam scale, height was measured to the nearest 0.1 cm using a stadiometer at the beginning of the behavioural weight loss program. BMI was calculated as weight in Kilograms divided by height in meters squared.|Mean BMI at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kg/m2||Standard Error|Mean
1308268|NCT02649634|Secondary|Adherence|The mean number of missed behavioural weight loss sessions (out of 24 sessions)|Assessed once at the end of the behavioural weight loss program (week 12)||||number of group sessions||Standard Deviation|Mean
1308269|NCT02649634|Secondary|Weight at 6 Month Follow up|a digital scale (Tanita BWB-800S), which assessed weight to the nearest 0.1 kg, was used for the 6 month follow-up assessment|Mean weight 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilograms||Standard Error|Mean
1308270|NCT02649634|Primary|Weight at End of Behavioural Weight Loss Program, 12 Weeks|Weight was measured to the nearest 0.1 kg using a balance beam scale|Mean weight recorded at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilograms||Standard Error|Mean
1308271|NCT02648438|Secondary|Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||(h*pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1308273|NCT02648438|Secondary|Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1308274|NCT02648438|Secondary|Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||(h*pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1308275|NCT02648438|Secondary|Observed Maximum Plasma Concentration (Cmax)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308276|NCT02648438|Secondary|PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1308277|NCT02648438|Primary|Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1308278|NCT02648204|Secondary|Change in Pulse Rate|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on safety analysis set.|||beats/min||Standard Error|Least Squares Mean
1308279|NCT02648204|Secondary|Change in Lipase|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for lipase.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
1308306|NCT02648022|Secondary|Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%|Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks||||percentage of participants|||Number
1308805|NCT02634580|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308280|NCT02648204|Secondary|Change in Amylase|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for amylase.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
1308281|NCT02648204|Secondary|Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the ‘on-treatment’ period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|40 weeks + follow-up of 5 weeks|Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.|||percentage of subjects|||Number
1308282|NCT02648204|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes|A treatment emergent hypoglycaemic episode was defined as an episode with onset in the ‘on-treatment’ period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|40 weeks + follow-up of 5 weeks|Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.|||hypoglycaemic episodes|||Number
1308283|NCT02648204|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A TEAE was defined as an AE with onset in the ‘on-treatment’ period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).|40 weeks + follow-up of 5 weeks|Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.|||events|||Number
1308284|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%|Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for HbA1c and body weight.|||percentage of subjects|||Number
1308285|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%|Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight|||percentage of subjects|||Number
1308286|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%|Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks of treatment|Analysis was based on FAS.|||percentage of subjects|||Number
1308323|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 8|mITT with a measurement at baseline and Week 8|||mg/dL||Standard Deviation|Mean
1308287|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain|Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was period where subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was subset of ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit|After 40 weeks of treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for this endpoint.|||percentage of subjects|||Number
1308288|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%|Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight|||percentage of subjects|||Number
1308289|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%|Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight.|||percentage of subjects|||Number
1308290|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target|Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks of treatment|Analysis was based on FAS.|||percentage of subjects|||Number
1308291|NCT02648204|Secondary|Change in Short Form Health Survey (SF-36v2™)|The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was period where subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number analysed=number of participants with available data for SF-36.|||units on a scale||Standard Error|Least Squares Mean
1308292|NCT02648204|Secondary|Change in Waist Circumference|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for waist circumference.|||cm||Standard Error|Least Squares Mean
1308324|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 4|mITT with a measurement at baseline and Week 4|||mg/dL||Standard Deviation|Mean
1308293|NCT02648204|Secondary|Change in Body Mass Index (BMI)|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for BMI.|||kg/m^2||Standard Error|Least Squares Mean
1308294|NCT02648204|Secondary|Change in Fasting Blood Lipids (Triglycerides)|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for triglycerides.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
1308295|NCT02648204|Secondary|Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for HDL cholesterol.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
1308296|NCT02648204|Secondary|Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for LDL cholesterol.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
1308297|NCT02648204|Secondary|Change in Fasting Blood Lipids (Total Cholesterol)|Results are based on the data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for total cholesterol|||ratio to baseline||Standard Error|Geometric Least Squares Mean
1308298|NCT02648204|Secondary|Change From Baseline 7-point Self-measured Plasma Glucose Increment|SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was period where subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose increment.|||mmol/L||Standard Error|Least Squares Mean
1308384|NCT02646124|Secondary|Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 72 Hours|Patients needing any analgesic or LBP medication within the previous 72 hours|Assessed three months after emergency department discharge|data not collected||||||
1308299|NCT02648204|Secondary|Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile|SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose.|||mmol/L||Standard Error|Least Squares Mean
1308300|NCT02648204|Secondary|HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target|Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Results are based on the FAS.|||percentage of subjects|||Number
1308301|NCT02648204|Secondary|Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire|The questionnaire contains 8 items and evaluates subjects’ diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was period where subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for diabetes treatment satisfaction questionnaire|||units on a scale||Standard Error|Least Squares Mean
1308302|NCT02648204|Secondary|Change in Systolic and Diastolic Blood Pressure|Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication.|Week 0, week 40|Analysis was based on FAS.|||mmHg||Standard Error|Least Squares Mean
1308303|NCT02648204|Secondary|Change in Fasting Plasma Glucose|Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose.|||mmol/L||Standard Error|Least Squares Mean
1308304|NCT02648204|Secondary|Change in Body Weight (kg)|Results are based on body weight data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on -treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication.|Week 0, week 40|Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight.|||kg||Standard Error|Least Squares Mean
1308305|NCT02648204|Primary|Change in HbA1c|Results are based on HbA1c data from on-treatment without rescue medication observation period. The ‘on-treatment’ observation period was the period where the subject was considered to be exposed to trial product. The ‘on-treatment without rescue medication’ observation period was a subset of the ‘on-treatment’ observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the ‘on-treatment’ observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS.|||percentage of HbA1c||Standard Error|Least Squares Mean
1308307|NCT02648022|Secondary|Percentage of Participants With Treatment Initiation and Completion|The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks||||percentage of Particpants|||Number
1308308|NCT02648022|Primary|Sustained Viral Response (SVR)|The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.|up to 24 weeks||||percentage of Participants|||Number
1308309|NCT02647944|Secondary|Gastric Accommodation Volume at 16 Weeks|Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|16 weeks (approximately 1 hour after 99mTC injection)|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
1308310|NCT02647944|Secondary|Gastric Postprandial Volume at 16 Weeks|Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
1308311|NCT02647944|Secondary|Gastric Fasting Volume at 16 Weeks|Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
1308312|NCT02647944|Secondary|Satiation Maximum Tolerated Volume at 16 Weeks|After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
1308313|NCT02647944|Secondary|Satiation Volume to Fullness at 16 Weeks|After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
1308314|NCT02647944|Secondary|Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks|"Satiety (a measure of appetite) was appraised by free feeding buffet meal consisting of standard foods of known nutrient composition. The total amount of food consumed was analyzed by the study dietitian."|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||kcal||Inter-Quartile Range|Median
1308315|NCT02647944|Secondary|Weight Change at 16 Weeks|Body weight in kg was measured at 16 weeks and compared to baseline.|baseline, 16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||kg||Inter-Quartile Range|Median
1308316|NCT02647944|Secondary|Weight Change at 5 Weeks|Body weight in kg was measured at 5 weeks and compared to baseline.|baseline, 5 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||kg||Inter-Quartile Range|Median
1308317|NCT02647944|Primary|Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks|Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||minutes||Inter-Quartile Range|Median
1308318|NCT02647944|Primary|Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks|Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.|5 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||minutes||Inter-Quartile Range|Median
1308319|NCT02647905|Other Pre-specified|CGM System Agreement With Reference Control|The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)|90 days||||percent of readings within 15/15%|||Number
1308320|NCT02647905|Primary|CGM Relative Difference to Laboratory Reference Reported as MARD|Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.|90 days||||percent||95% Confidence Interval|Mean
1308321|NCT02647320|Secondary|Count of Participants With HbA1c Less Than 7.0% at Week 12|HbA1C less than 7% is the success goal for many Type 2 diabetics.|Week 12|mITT|||Participants|||Count of Participants
1308322|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 12|mITT with a measurement at baseline and Week 12|||mg/dL||Standard Deviation|Mean
1338511|NCT01963091|Primary|Salivary Cortisol Levels|salivary cortisol|0 minutes post 15 minute stress task||||mg/dl||Standard Deviation|Mean
1308325|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 2|mITT with a measurement at baseline and Week 2|||mg/dL||Standard Deviation|Mean
1308326|NCT02647320|Secondary|Change From Baseline in Cmax of PG in Response to MMTT at Week 12|Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.|Baseline, Week 12|mITT with a measurement at baseline and Week 12|||mg/dL||Standard Deviation|Mean
1308327|NCT02647320|Secondary|Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4|Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.|Baseline, Week 4|mITT with a measurement at baseline and Week 4|||mg/dL||Standard Deviation|Mean
1308328|NCT02647320|Secondary|Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12|"The MMTT requires a participant to drink a mixed meal, such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement."|Baseline, Week 12|mITT with a measurement at baseline and Week 12|||(mg/dL)*hr||Standard Deviation|Mean
1308329|NCT02647320|Secondary|Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4|"The MMTT requires a participant to drink a mixed meal, such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement."|Baseline, Week 4|mITT with a measurement at baseline and Week 4|||(mg/dL)*hr||Standard Deviation|Mean
1308330|NCT02647320|Secondary|Change From Baseline in Triglycerides at Week 12|Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.|Baseline, Week 12|mITT|||percent change in triglycerides||Standard Deviation|Mean
1308331|NCT02647320|Secondary|Change From Baseline in Non-HDL-C at Week 12|"Non-HDL-C is the measure of bad cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5)."|Baseline, Week 12|mITT|||Percent change in Non-HDL-C||Standard Deviation|Mean
1308332|NCT02647320|Secondary|Change From Baseline in HDL-C at Week 12|"HDL-C is known as the good cholesterol, so a higher score (positive change) means improvement."|Baseline, Week 12|mITT|||percent change in HCL-C||Standard Deviation|Mean
1308333|NCT02647320|Secondary|Change From Baseline in LDL-C at Week 12|"LDL-C is known as the bad cholesterol, so a lower score (negative change) means improvement."|Baseline, Week 12|mITT|||percent change in LDL-C||Standard Deviation|Mean
1308334|NCT02647320|Secondary|Change From Baseline in Total Cholesterol (TC) at Week 12|"Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the bad cholesterol, high-density lipoprotein cholesterol (HDL-C) - the good cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol."|Baseline, Week 12|mITT|||percent change in TC||Standard Deviation|Mean
1308335|NCT02647320|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12|Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.|Baseline, Week 12|Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.|||percent of HbA1c||Standard Deviation|Mean
1308336|NCT02647281|Secondary|Tmax, T1/2 and Tlag of the Metabolite of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of the metabolite of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308337|NCT02647281|Secondary|Ctau, C24 and Cmax of the Metabolite of GSK3389404 Following Dosing of GSK3389404 on Day 22 of Part 2|Blood samples were collected to evaluate Ctau, C24 and Cmax of the metabolite of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308338|NCT02647281|Secondary|AUC(0-24) and AUC(0-tau) of the Metabolite of GSK3389404 Following Dosing of GSK3389404 on Day 22 of Part 2|Blood samples were collected to evaluate AUC (0-24) and AUC (0-tau) of the metabolite of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1314904|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN||96 weeks||||participants|participants||Number
1308339|NCT02647281|Secondary|Tmax, T1/2 and Tlag of the Metabolite of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308340|NCT02647281|Secondary|Cmax, C24 and C168 of the Metabolite of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Cmax, C24 and C168 of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308341|NCT02647281|Secondary|AUC (0-t), AUC(0-24), AUC(0-168) and AUC (0-inf) of the Metabolite of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate AUC (0-t), AUC (0-24), AUC (0-168) and AUC (0-inf) of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308342|NCT02647281|Secondary|Tmax, T1/2 and Tlag of the Metabolite of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308343|NCT02647281|Secondary|Cmax, C24 and C168 of the Metabolite of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Cmax, C24 and C168 of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308344|NCT02647281|Secondary|AUC (0-inf), AUC(0-t), AUC(0-24) of the Metabolite of GSK3389404 After Single Dose in Part 1|Blood samples were collected to evaluate AUC (0-inf), AUC (0-t) and AUC (0-24) of metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
1308345|NCT02647281|Secondary|Trough Plasma Concentrations of GSK3389404 in Part 2|For Part 2, mean plasma GSK3389404 pre-dose values between Day 1 to Day 29 and Ctau were plotted against time to assess attainment of GSK3389404 steady state following multiple dose administration. Achievement of plasma GSK3389404 steady-state was assessed by calculating the 90% confidence interval (CI) of the slope of the linear regression of log (Ctau) versus time. NA indicates data was not available.|Pre-dose on Days 8, 15, 22 and 29|Pharmacokinetic Concentration Population|||Ratio||Standard Deviation|Mean
1308346|NCT02647281|Secondary|Time Invariance (LI) of GSK3389404 in Part 2|For Part 2, time invariance was evaluated by comparing AUC (0-tau) for Day 22 to AUC (0-inf) for Day 1. For each dose level, a linear mixed effect model was fitted with the log transformed PK parameter as the dependent variable, day as a fixed effect and subject as a random effect. Only those participants with data available at the specified time points were analyzed.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose; Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||Ratio||Standard Deviation|Mean
1308347|NCT02647281|Secondary|Accumulation Ratio by AUC (RAUC), by Cmax (RCmax), by C24 (RC24) and by Ctau (RCtau) of GSK3389404 in Part 2|For Part 2, the extent of accumulation of GSK3389404 was evaluated by comparing AUC (0-tau), Cmax, C24 and Ctau on Day 22 to AUC (0-168), Cmax, C24 and C168 on Day 1. For each dose level, a linear mixed effect model was fitted with the log transformed PK parameter as the dependent variable, day as a fixed effect and subject as a random effect.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose; Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Ratio||Standard Deviation|Mean
1308348|NCT02647281|Secondary|Dose Proportionality of GSK202007 for Dose Range 30 mg - 120 mg After Multiple Dose Administrations|Results of proportionality assessment using power model and ANOVA following multiple doses are presented. Slope estimates and 90% confidence interval are presented for Day 22 of Part 2.|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115) in Part 2|Pharmacokinetic Concentration Population|||ratio||90% Confidence Interval|Number
1308385|NCT02646124|Secondary|Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours|Telephone questionnaire is used to assess patients needing any analgesic or low back pain medication within the previous 24 hours.|One week after discharge from the emergency department||||Participants|||Count of Participants
1308349|NCT02647281|Secondary|Dose Proportionality of GSK202007 for Dose Range 10 mg - 120 mg After Single Dose Administrations|Results of dose proportionality assessment using power model and analysis of variance (ANOVA) following single dose administariton (Part 1 and Day 1 in Part 2) are presented. Slope estimates and 90% confidence interval are presented for combined data of Day 1 of Part 1 and 2.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose; Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose in Part 2.|Pharmacokinetic Concentration Population (combined for Part 1 and 2). Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||ratio||90% Confidence Interval|Number
1308350|NCT02647281|Primary|Cl/F of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Cl/F of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||Liter per hour||Standard Deviation|Mean
1308351|NCT02647281|Primary|Tmax, T1/2 and Tlag of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||Hour||Standard Deviation|Mean
1308352|NCT02647281|Primary|Observed Concentration at the End of the Dosing Interval (Ctau), C24 and Cmax of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Ctau, C24 and Cmax of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days ).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||ng/mL||Standard Deviation|Mean
1308353|NCT02647281|Primary|AUC(0-24) and AUC From Time Zero to the End of the Dosing Interval [AUC(0-tau)] of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate AUC (0-24) and AUC (0-tau) of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days ).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||ng*hour/mL||Standard Deviation|Mean
1308354|NCT02647281|Primary|CL/F of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate CL/F of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose. Only those participants with data available at the specified time points were analyzed.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population|||Liter per hour||Standard Deviation|Mean
1308355|NCT02647281|Primary|Tmax, T1/2 and Tlag of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Hour||Standard Deviation|Mean
1308356|NCT02647281|Primary|Cmax, C24 and C168 of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Cmax, C24 and C168 of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population|||ng/mL||Standard Deviation|Mean
1308357|NCT02647281|Primary|AUC (0-t), AUC(0-24), AUC From Time Zero to 168 Hours Post-dose [AUC(0-168)] and AUC (0-inf) of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate AUC (0-t), AUC (0-24), AUC (0-168) and AUC (0-inf) of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||ng*hour/mL||Standard Deviation|Mean
1308358|NCT02647281|Primary|Apparent SC Plasma Clearance (CL/F) of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate CL/F of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||Liter per hour||Standard Deviation|Mean
1308359|NCT02647281|Primary|Time to Maximum Observed Concentration (Tmax), Terminal Half-life (T1/2) and Lag Time (Tlag) of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||Hour||Standard Deviation|Mean
1308360|NCT02647281|Primary|Maximum Observed Concentration (Cmax), Observed Concentration at 24 Hours (C24) and at 168 Hours (C168) of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Cmax, C24 and C168 of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||ng/mL||Standard Deviation|Mean
1308386|NCT02646124|Secondary|Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale|Patients with moderate or serve pain. Worst Lower Back Pain (LBP) over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.|1 week after discharge from emergency department||||Participants|||Count of Participants
1338582|NCT01961115|Secondary|Overall Response Rate Using the RECIST or Immune-Related Response Criteria (irRC)_v2||Up to 1 year|Data were not collected||||||
1308361|NCT02647281|Primary|Area Under the Plasma Concentration Curve (AUC) From Time Zero to Infinity [AUC (0-inf)], AUC From Time Zero to the Time of Last Quantifiable Concentration [AUC(0-t)], AUC From Time Zero to 24 Hours [AUC(0-24)] of GSK3389404 After Single Dose in Part 1|Blood samples were collected to evaluate AUC (0-inf), AUC (0-t) and AUC (0-24) of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose. Pharmacokinetic Concentration Population was defined as participants who underwent plasma PK sampling and had evaluable PK assay results post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||Nanogram*hour per milliliter(ng*hour/mL)||Standard Deviation|Mean
1308362|NCT02647281|Primary|Number of Participants With 12-lead Electrocardiogram (ECG) Findings in Part 1|12-lead ECGs were recorded at Baseline (Day 1, pre-dose) and at 1, 4, 8, 12, 24 and 48 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants with worst change from Baseline in ECG have been presented as clinically significant (CS) change or not a clinically significant (NCS) change.|Day 1 (pre-dose) and up to 31 days|Safety Population|||Participants|||Count of Participants
1308363|NCT02647281|Primary|Change From Baseline in Body Temperature at the Indicated Time Points in Part 2|Body temperature was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Degree Celsius||Standard Deviation|Mean
1308364|NCT02647281|Primary|Change From Baseline in RR at the Indicated Time Points in Part 2|Respiratory rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Breaths per minute||Standard Deviation|Mean
1308365|NCT02647281|Primary|Change From Baseline in PR at the Indicated Time Points in Part 2|Pulse rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||bpm||Standard Deviation|Mean
1308366|NCT02647281|Primary|Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2|SBP and DBP were taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113 +- 2 days). Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||mmHg||Standard Deviation|Mean
1308367|NCT02647281|Primary|Change From Baseline in Body Temperature at the Indicated Time Points in Part 1|Temperature was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population|||Degree Celsius||Standard Deviation|Mean
1308368|NCT02647281|Primary|Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1|Respiratory rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Breaths per minute||Standard Deviation|Mean
1308369|NCT02647281|Primary|Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1|Pulse rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
1308370|NCT02647281|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1|SBP and DBP were taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1308667|NCT02638259|Secondary|Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Patients|Frequency of patients having anti-drug antibody (ADA) during 24 weeks (Treatment Period 1) using 1% false positive rate|Treatment Period 1, 24 weeks|Safety Set|||Participants|||Count of Participants
1308371|NCT02647281|Primary|Change From Baseline in Complement Factor Bb Levels in Part 2|Blood samples were collected to evaluate complement factors C5a levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and Day 22|Safety Population|||mg/L||Standard Deviation|Mean
1308372|NCT02647281|Primary|Change From Baseline in Complement Factor C5a Levels in Part 2|Blood samples were collected to evaluate complement factors C5a levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and Day 22|Safety Population|||ug/L||Standard Deviation|Mean
1308373|NCT02647281|Primary|Change From Baseline in Complement Factor C3 and C4 Levels in Part 2|Blood samples were collected to evaluate complement factors (C3 and C4) levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between minimum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration|Day 1 (pre-dose) and Day 22|Safety Population|||G/L||Standard Deviation|Mean
1308374|NCT02647281|Primary|Change From Baseline in Complement Split Product Bb Levels in Part 1|Blood samples were collected to evaluate complement split product Bb levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (highest of the measurements for specimens collected) observed post-dose and pre-study drug administration|Day 1 (pre-dose) and up to 31 days|Safety Population|||mg per liter (mg/L)||Standard Deviation|Mean
1308375|NCT02647281|Primary|Change From Baseline in Complement Split Product C5a Levels in Part 1|Blood samples were collected to evaluate complement split product C5a levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (highest of the measurements for specimens collected) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and up to 31 days|Safety Population|||Microgram per liter (ug/L)||Standard Deviation|Mean
1308376|NCT02647281|Primary|Change From Baseline in Complement Factor Component 3 (C3) and C4 Levels in Part 1|Blood samples were collected to evaluate complement factors (C3 and C4) levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between minimum level (lowest of the measurements for specimens collected) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and up to 31 days|Safety Population|||Gram per liter (g/L)||Standard Deviation|Mean
1308377|NCT02647281|Primary|Number of Participants With Laboratory Values of Potential Clinical Importance in Part 2|Blood samples were collected for hematology, clinical chemistry, coagulation parameters and urinalysis. Abnormalities of potential clinical importance were evaluated as per DAIDS table for grading the severity of adult and pediatric adverse events. Laboratory abnormalities of DAIDS Grade 1 or higher were considered as of potential clinical importance and were summarized.|Up to 115 days|Safety Population|||Participants|||Count of Participants
1308378|NCT02647281|Primary|Number of Participants With Laboratory Values of Potential Clinical Importance in Part 1|Blood samples were collected for hematology, clinical chemistry, coagulation parameters and urinalysis. Abnormalities of potential clinical importance were evaluated as per Division of Acquired Immune Deficiency Syndrome [DAIDS] table for grading the severity of adult and pediatric adverse events. Laboratory abnormalities of DAIDS Grade 1 or higher were considered as of potential clinical importance and were summarized.|Up to 62 days|Safety Population|||Participants|||Count of Participants
1308379|NCT02647281|Primary|Number of Participants With Any Non-serious AE; Any SAE; Any AELD in Part 2|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AELD were considered for analysis.|Up to 115 days|Safety Population|||Participants|||Count of Participants
1308380|NCT02647281|Primary|Number of Participants With Any Non-serious Adverse Event (AE); Any Serious AE (SAE); Any AEs Leading to Discontinuation of Study Treatment (AELD) in Part 1|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AELD were considered for analysis. Safety Population comprised of all participants who received at least 1 dose of study treatment.|Up to 62 days|Safety Population|||Participants|||Count of Participants
1308381|NCT02646449|Primary|Level of Depressive Symptoms|Level of depressive symptoms, as indicated by the score on the Beck Depression Inventory. The Beck Depression Inventory II scoring range is as follows: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms and 29-63 severe depressive symptoms.|12 Weeks||||units on a scale||Standard Deviation|Mean
1308382|NCT02646449|Primary|Drinks Per Drinking Day|Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.|12 Weeks||||Drinks per drinking day||Standard Deviation|Mean
1308383|NCT02646124|Secondary|Participants Satisfied With Treatment|"Participants who answered Yes when asked the question Do you want to receive the same combination of medications during a subsequent visit to the ER?"|1 week||||Participants|||Count of Participants
1308387|NCT02646124|Primary|Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score."|Between baseline and one week after emergency department discharge||||units on a scale||95% Confidence Interval|Mean
1308388|NCT02645760|Secondary|Change From Baseline in Repositioning Error on Repositioning Test at Week 7|This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group|||centimeter||Standard Deviation|Mean
1308389|NCT02645760|Secondary|Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober’s Test at Week 7|Modified-modified Schober’s test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group|||centimeter||Standard Deviation|Mean
1308390|NCT02645760|Secondary|Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7|This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group|||units on a scale||Standard Deviation|Mean
1308391|NCT02645760|Primary|Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7|The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)|baseline an week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group.|||units on a scale||Standard Deviation|Mean
1308392|NCT02645253|Secondary|Pharmacodynamic Analysis of AZD7594 by Assessment of Plasma Concentration of Osteocalcin|Assessment of the plasma PD following a single dose of AZD7594|Day 1 (predose) and Day 16 (24 hours postdose)|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||μg/L||Standard Deviation|Mean
1308393|NCT02645253|Secondary|Pharmacodynamic Analysis of AZD7594 by Assessment of Plasma Concentration of Dehydroepiandrosterone Sulphate (DHEAS)|Assessment of the plasma PD following a single dose of AZD7594|Day 1 (predose) and Day 16 (24 hours postdose)|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||μmol/L||Standard Deviation|Mean
1308394|NCT02645253|Secondary|Pharmacodynamic Analysis of AZD7594 by Assessment of the Area Under the Effect Curve for Plasma Cortisol From Time Zero to 24 Hours After Dosing (AUEC [0-24]).|"Assessment of the plasma pharmacodynamics (PD) effects of AZD7594 after single and multiple ascending inhaled doses.~AUEC(0-24) was defined as area under the effect curve for plasma cortisol from time zero to 24 hours after dosing."|Day -1 (- 24 hours predose) up to 24 hours postdose; Day 1 and Day 16|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||min*nmol/L||Standard Deviation|Mean
1308395|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Renal Clearance, Estimated by Dividing Ae(0-96) by AUC(0-96) (CLR)|"Assessment of the urine PK following a single dose of AZD7594.~CLR was defined as the renal clearance, estimated by dividing Ae(0-96) by AUC(0-96)."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1308406|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of AUC(0-24)|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-24) was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing"|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1308396|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Percentage of Dose Excreted Unchanged Into the Urine From Time Zero to the Last Measured Time Point for an AZD7594, Estimated by Dividing Ae(0-last) by Dose (fe(0-last)%)|"Assessment of the urine PK following a single dose of AZD7594.~fe(0-last)% was defined as Percentage of dose excreted unchanged into the urine from time zero to the last measured time point for an AZD7594, estimated by dividing Ae(0-last) by dose."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage of dose excreted unchanged||Standard Deviation|Mean
1308397|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Cumulative Amount of AZD7594 Excreted From Time Zero to the Last Sampling Interval (Ae [0-last])|"Assessment of the urine PK following a single dose of AZD7594.~Ae(0-last) was defined as Cumulative amount of AZD7594 excreted from time zero to the last sampling interval."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol||Standard Deviation|Mean
1308398|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Amount of AZD7594 Excreted Into the Urine From Time t1 to t2 (Ae [t1-t2])|"Assessment of the urine PK following a single dose of AZD7594.~Ae (t1-t2) was defined as the amount of AZD7594 excreted into the urine from time t1 to t2."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol||Standard Deviation|Mean
1308399|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Temporal Change Parameter (TCP)|"Assessment of the plasma PK following a single dose of AZD7594.~Temporal change parameter, calculated as AUC(0-24) [Day 16]/AUC [Day 1].~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1308400|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Accumulation Ratio Calculated as AUC(0-24) on Day 16/AUC (0-24) on Day 1 (RAC).|"Assessment of the plasma PK following a single dose of AZD7594.~Accumulation ratio calculated as AUC(0-24) on Day 16/AUC(0-24) on Day 1."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1308401|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Peak Trough Fluctuation (%Fluctuation).|"Assessment of the plasma PK following a single dose of AZD7594.~Peak trough fluctuation calculated as [100*(Css,max– Css,min)/Cav]."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||Percentage of fluctuation||Geometric Coefficient of Variation|Geometric Mean
1308402|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of t1/2λz.|"Assessment of the plasma PK following a single dose of AZD7594.~t1/2λz was defined as half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve.~Participant count analyzed = 1"|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1308403|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of Lamda z (λz)|"Assessment of the plasma PK following a single dose of AZD7594.~λz was defined as terminal elimination rate constant, estimated by log-linear least."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||l/hour||Geometric Coefficient of Variation|Geometric Mean
1308404|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment AUC(0-24)/D.|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-24)/D was defined as the area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol*h/L)/umol||Geometric Coefficient of Variation|Geometric Mean
1308405|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Css,Max Divided by the Dose Administered (Css,Max/D).|"Assessment of the plasma PK following a single dose of AZD7594.~Css,max/D was defined as observed maximum plasma concentration divided by the dose administered."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol/L)/umol||Geometric Coefficient of Variation|Geometric Mean
1308407|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the AUC(0-last)|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-last) was defined as Area under the plasma concentration-time curve from time zero to the time of the last quantifiable analyte concentration."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1308408|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Tmax at Steady State (Tss,Max).|"Assessment of the plasma PK following a single dose of AZD7594.~tss,max was defined as Time to reach maximum concentration, taken directly from the individual concentration-time curve."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Full Range|Median
1308409|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Average Concentration Over One Dosing Interval (Cav)|"Assessment of the plasma PK following a single dose of AZD7594.~Cav was defined as average concentration over one dosing interval."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308410|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Cmin at Steady State (Cmin, ss)|"Assessment of the plasma PK following a single dose of AZD7594.~Cmin, ss was defined as observed minimum concentration, taken directly from the individual concentration-time curve."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308411|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Cmax at Steady State (Css,Max).|"Assessment of the plasma PK following a single dose of AZD7594.~Css,max was defined as observed maximum plasma concentration at steady state, taken directly from the individual concentration-time curve."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308412|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Observed Minimum Plasma Concentration (Cmin)|Cmin was defined as observed minimum plasma concentration, taken directly from the individual concentration-time curve|Days 5 to 15: Pre-dose|The pharmacokinetic (PK) analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308413|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the AUC(0-24) Divided by the Dose Administered (AUC(0-24)/D)|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-24)/D was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol*h/L)/umol||Geometric Coefficient of Variation|Geometric Mean
1308414|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the AUC Divided by the Dose Administered (AUC/D).|"Assessment of the plasma PK following a single dose of AZD7594.~AUC/D was defined as Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered.~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol*h/L)/umol||Geometric Coefficient of Variation|Geometric Mean
1308415|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Cmax Divided by the Dose Administered (Cmax/D).|"Assessment of the plasma PK following a single dose of AZD7594.~Cmax/D was defined as observed maximum plasma concentration divided by the dose administered."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol/L)/umol||Geometric Coefficient of Variation|Geometric Mean
1308424|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Time to Reach Maximum Plasma Concentration (Tmax)|"Assessment of the plasma PK following a single dose of AZD7594.~tmax was defined as time to reach maximum plasma concentration, taken directly from the individual concentration-time curve."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Full Range|Median
1308416|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration, Estimated by Dividing CL/F by Lamda z (Vz/F)|"Assessment of the plasma PK following a single dose of AZD7594.~Vz/F was defined as apparent volume of distribution during the terminal phase after extravascular administration, estimated by dividing the apparent clearance (CL/F) by λz.~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Litres||Geometric Coefficient of Variation|Geometric Mean
1308417|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (AZD7594) (CL/F).|"Assessment of the plasma PK following a single dose of AZD7594.~CL/F was defined as apparent total body clearance after extravascular administration estimated as dose divided by AUC (AZD7594).~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1308418|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Mean Residence Time From Time Zero Extrapolated to Infinity (MRT).|"Assessment of the plasma PK following a single dose of AZD7594.~MRT was defined as Mean residence time from time zero extrapolated to infinity.~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1308419|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Half-life Associated With the Terminal Slope of a Semi-logarithmic Concentration-time Curve (t1/2λz).|"Assessment of the plasma PK following a single dose of AZD7594.~t1/2λz was defined as half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve.~NOTE: No results were available for participants belonging to AZD7594 400ug group."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Standard Deviation|Mean
1308420|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Terminal Elimination Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve(Lamda z or λz).|"Assessment of the plasma PK following a single dose of AZD7594.~λz was defined as terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||l/h||Geometric Coefficient of Variation|Geometric Mean
1308421|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero Extrapolated to Infinity (AUC).|"Assessment of the plasma PK following a single dose of AZD7594.~AUC was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUC(0-last) + Clast/λz where Clast is the last observed quantifiable concentration.~NOTE: No results were available for participants belonging to AZD7594 2ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308422|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero to 24 Hours After Dosing (AUC [0-24]).|"Assessment of the plasma PK following a single dose of AZD7594.~AUC (0-24) was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308423|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC [0-last])|"Assessment of the plasma PK following a single dose of AZD7594.~AUC (0-last) was defined as the area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308467|NCT02643004|Secondary|Visual Acuity|Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.|Baseline and 1 week|Protocol deviations occurred and therefore resulted in incomplete data sets.|||LogMAR||Standard Deviation|Mean
1308425|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Observed Maximum Plasma Concentration (Cmax)|"Assessment of the plasma PK following a single dose of AZD7594.~Cmax was defined as observed maximum plasma concentration, taken directly from the individual concentration-time curve."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The pharmacokinetic (PK) analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1308426|NCT02645253|Primary|Safety and Tolerability of AZD7594 by Assessment of the Number of Participants With Adverse Events|To assess the safety and tolerability of single and multiple doses of AZD7594|At screening (Day -28, Day -02 and Day -1), Treatment period (Days 1 to 20) and Follow-up (Day 29).|All subjects who received at least one dose of IMP and for whom any post-dose data were available were included in the safety analysis set.|||Pariticpants|||Number
1308427|NCT02645123|Primary|Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)|The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F&frmType=image&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.|before the beginning and after the end of 5 weeks for each patient|all participants were chronic low back pain patients with a variable degree of vertebral disc degeneration defined by the modified Pfirrmann scale|||quotient: degrees/degrees=no unit||Standard Deviation|Mean
1308428|NCT02645123|Primary|Change in the Roland-Morris Disability Questionnaire|"The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain.~For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability."|before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient||||units on a scale||Standard Deviation|Mean
1308429|NCT02645123|Primary|Change in the Oswestry Low Back Pain Disability Index|this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points|before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient||||units on a scale||Standard Deviation|Mean
1308430|NCT02645123|Primary|Change in the Numerical Pain Rating Scale|this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.|before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient||||units on a scale||Standard Deviation|Mean
1308431|NCT02644356|Secondary|Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care|"Investigator-generated scale of perceived importance and relevance of course content: To what degree do you think this course could potentially contribute to improved patient care? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
1308432|NCT02644356|Secondary|Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches|"Investigator-generated scale of perceived importance and relevance of course content: How relevant is the content of this course for increasing palliative care providers' knowledge of non-pharmacological approaches? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
1308433|NCT02644356|Secondary|Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches|"Investigator-generated scale of perceived importance and relevance of course content: How important is it for palliative care providers to know about non-pharmacological approaches to symptom management? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
1308434|NCT02644356|Secondary|Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days|Investigator-generated scale of confidence in communicating about the modality to patients, families and colleagues in PC contexts. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
1308435|NCT02644356|Secondary|Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days|Investigator-generated scale of confidence in making evidence-based recommendations about the modality. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
1308436|NCT02644356|Secondary|Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days|Investigator-generated scale of confidence in understanding modality safety considerations. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
1308468|NCT02643004|Secondary|Lens Movement|Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
1313085|NCT02488980|Other Pre-specified|Safety (SAEs and AEs)|The most commonly reported experiences in subject occurring in at least 20% of subjects in any treatment group.|28 weeks||||participants|||Number
1308437|NCT02644356|Primary|Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days|Investigator-generated test of change in knowledge about theory, mechanisms of action, delivery, indications for use, evidence of efficacy; total of 45 multiple choice questions covering three modalities: acupuncture, massage, and music interventions. Range of total possible correct responses was from 0-45, with subscores as follows: range for acupuncture, 0-15; massage, 0-16; music interventions, 0-14. Total score is the sum of the combined subscores.|Baseline, 30 days|Disciplines: Nursing, 22; physician, 11; social work, 13; chaplaincy, 4; administrators, 4; counseling/psychology, 2 (some reported more than one discipline).|||units on a scale||Standard Deviation|Mean
1308438|NCT02644122|Secondary|To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-||4 years|||||||
1308439|NCT02644122|Secondary|To Assess the Effect of SF1126 on Overall Survival.||4 years|||||||
1308440|NCT02644122|Secondary|To Assess the Effect of SF1126 on Time to Progression.||4 years|||||||
1308441|NCT02644122|Secondary|Number of Participants With Treatment-related Adverse Events||4 years||||Participants|||Count of Participants
1308442|NCT02644122|Primary|To Determine ORR|best response of PR or CR observed within 6 months of enrollment|6 months|||||||
1308443|NCT02644109|Primary|Serum LDL Cholesterol||1 month||||mg/dl||Standard Deviation|Mean
1308444|NCT02644096|Primary|Change in Physical Dimensions in Health Status of Elderly Patients From 4 Weeks Pre Operatively to 9 Months Post Operatively After THR. Health Status is Measured by the Questionnaire Short-form 36 (SF-36).|"The health status was assessed by Short-Form 36 (SF-36) which is a self-administered generic questionnaire that has been shown to be reliable and valid for measuring functioning, well-being and general health status. The instrument measures the eight health dimensions listed in figure 3. Reflecting the impact of both dysfunctions and general health perception the questionnaire measures: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score).~All patients who had been consecutively admitted for THR were mailed an introduction letter together with a questionnaire containing a number and a prepaid return envelope. In the questionnaire they were asked to give demographic data and assess their health status"|Four weeks preoperatively and nine moths after discharge.|Patients who have completed the study and contributed with answers on the SF-36 questionnaire.|||Scores on SF-36 questionnaires||95% Confidence Interval|Mean
1308445|NCT02643862|Secondary|Desensitization Measured to Increased Doses Measured by Proportion of FA Participants Who Pass a DBPCFC to 4,000 mg Each of 2 Allergens at Week 36|"Proportion of FA participants who pass a DBPCFC to 4,000 mg each of 2 allergens at week 36.~Greater than 3 foods at 36 weeks for~Xolair: 21/26 (80.8%) Placebo: 2/7 (28.6%)"|36 weeks|We analyzed an ITT|||Participants|||Count of Participants
1308446|NCT02643862|Primary|Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36|"Proportion of food allergic (FA) participants who pass a DBPCFC to 2,000 mg protein for each of 2 allergens at week 36.~Xolair arm: 30/36 (83.3%) Placebo arm: 4/12 (33.3%)"|36 weeks|this is an ITT population|||Participants|||Count of Participants
1308447|NCT02643615|Secondary|Safety of Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA|Number of participants experiencing adverse events related to the study procedures during prone surgery and 24 hours after surgery under balanced general anesthesia versus TIVA|From start of surgery up to 24 hours after surgery||||Participants|||Count of Participants
1308448|NCT02643615|Secondary|The Difference in VEP Changes in Amplitude Among Both Groups|The difference in VEP changes in amplitude with a single and double stimuli using the SightSaver visual stimulator under balanced general anesthesia versus TIVA.|every 30 minutes during the entire procedure for up to 6 hours||||milliseconds (ms)||95% Confidence Interval|Mean
1308449|NCT02643615|Secondary|The Difference in VEP Changes in Amplitude Among Both Groups|VEP waveforms were evaluated using either present baseline - reproducible positive-negative-positive complex of substantial amplitude (≥2 µV) that appeared 100-200 ms after pulse stimulus onset; marginal Baseline – low amplitude (<2 µV) reproducible P100 waveform; or absent baseline – no repeatable response present. Any activity of <0.5 µV was not considered a response. Best derivation for each particular patient was used for monitoring electroretinogram (ERG) recording and confirming the stimulation.|Every 30 minutes during surgery for up to 6 hours||||micorvolts (µV)||95% Confidence Interval|Median
1308450|NCT02643615|Primary|Efficacy in Detecting Subtle Intraoperative VEP Changes Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA.|Number of Participants with Subtle Intraoperative VEP Changes Observed Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA|VEP waveforms recorded every 30 minutes during the entire procedure for up to 6 hours.||||Participants|||Count of Participants
1308451|NCT02643394|Secondary|Morphine Equivalents of Postoperative Opioid Usage|Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours|an expected average of 6 hours|Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.|||Morphine equivalent (mg)||Inter-Quartile Range|Median
1308452|NCT02643394|Primary|Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)|Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)|1-h postoperatively|Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.|||units on a scale||Inter-Quartile Range|Median
1308469|NCT02643004|Secondary|Lens Movement|Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|Baseline||||percentage of subjects|||Number
1308470|NCT02643004|Secondary|Vertical Centration|Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
1308471|NCT02643004|Secondary|Vertical Centration|Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|Baseline||||percentage of subjects|||Number
1308453|NCT02643251|Secondary|Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worse score from Day -14 to Day -8) to End-of-Treatment (worse score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “worse pain in the past 24 hours in the painful areas of the feet” from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
1308454|NCT02643251|Primary|Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “average pain in the past 24 hours in the painful areas of the feet” averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
1308455|NCT02643225|Primary|The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)|The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.|at birth|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.|||participants|||Number
1308456|NCT02643225|Secondary|Interventricular Septum Thickness|The interventricular septum thickness will be measured by ultrasound examination|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.|||mm||Standard Deviation|Mean
1308457|NCT02643225|Secondary|Prediction of Fetal Macrosomia by Measuring HbA1C in Participants|Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee|||percentage of glycosolated hemoglobin||Standard Deviation|Mean
1308458|NCT02643225|Secondary|Umbilical Cordcross-sectional Area|the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee|||cm^2||Standard Deviation|Mean
1308459|NCT02643199|Secondary|Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound|"Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:~Four chamber view~Five chamber view~Left outflow tract~Right outflow tract~3 vessels and Trachea View~Abdomen/Stomach~Ductal arch~aortic arch~Bicaval view then we count howmuch views of nine views were satisfactory"|20 - 36 weeks of gestation||||Number of satisfactory views||Standard Deviation|Mean
1308460|NCT02643199|Primary|Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound|"Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:~Four chamber view~Five chamber view~Left outflow tract~Right outflow tract~3 vessels and Trachea View~Abdomen/Stomach~Ductal arch~aortic arch~Bicaval view then we count howmuch views of nine views were satisfactory"|20 - 36 weeks of gestation||||Number of satisfactory views||Standard Deviation|Mean
1308461|NCT02643004|Secondary|Lens Surface - Wettability|Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
1308462|NCT02643004|Secondary|Lens Surface - Wettability|Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline||||percentage of subjects|||Number
1308463|NCT02643004|Secondary|Lens Surface - Debris|Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
1308464|NCT02643004|Secondary|Lens Surface - Debris|Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline||||percentage of subjects|||Number
1308465|NCT02643004|Secondary|Lens Surface - Deposition|Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
1308466|NCT02643004|Secondary|Lens Surface - Deposition|Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline||||percentage of subjects|||Number
1314237|NCT02454101|Secondary|Maternal Need for Blood Transfusion.|number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion|1st 24 hours after delivery||||participants|||Number
1308472|NCT02643004|Secondary|Horizontal Centration|Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
1308473|NCT02643004|Secondary|Horizontal Centration|Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|Baseline||||percentage of subjects|||Number
1308474|NCT02643004|Primary|Vision|Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
1308475|NCT02643004|Primary|Dryness|Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.|1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
1308476|NCT02643004|Primary|Comfort|Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
1308477|NCT02643004|Primary|Overall Subjective Score of Lenses|Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
1308478|NCT02643004|Primary|Ocular Physiology|Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.|Baseline and 1 week|Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
1308479|NCT02642835|Secondary|Number of Participants Who Experienced Intraoperative Complications|This records any problems that were encountered at the original insertion of the mesh. clinic visit|1 hour||||Participants|||Count of Participants
1308480|NCT02642835|Secondary|Number of Participants Who Needed Reoperations for Pain|patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit|1 hour||||Participants|||Count of Participants
1308481|NCT02642835|Secondary|Number of Participants Who Needed Surgical Mesh Removal for Erosion|A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit|1 hour||||Participants|||Count of Participants
1308482|NCT02642835|Secondary|Number of Participants Who Rated Their Improvement as Better or Very Much Better|The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit|1 hour||||Participants|||Count of Participants
1308483|NCT02642835|Secondary|Number of Participants Who Developed New Stress Incontinence|The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit|1 hour||||Participants|||Count of Participants
1308484|NCT02642835|Secondary|Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment|This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.|1 hour||||Participants|||Count of Participants
1308485|NCT02642835|Secondary|Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina|clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment|1 hour||||Participants|||Count of Participants
1308486|NCT02642835|Secondary|Number of Participants Complaining of a Bulge. Recurrent Prolapse|Efficacy determined by the question in the pelvic floor prolapse distress inventory “usually have a bulge or something falling out that you can see or feel in your vaginal area”. Determined at clinic visit by questioning|1 hour||||Participants|||Count of Participants
1308487|NCT02642835|Secondary|Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination|"The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.~A stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina."|1 hour||||Participants|||Count of Participants
1308488|NCT02642835|Primary|The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted|clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.|1 hour||||Participants|||Count of Participants
1308489|NCT02642679|Secondary|Wound Healing Quality|Assessed using the Vancouver scar scale (VSS) 1-month post-operatively. The VSS is a widely used scale in clinical practice to document change in scar appearance. The scale scores four parameters: pigmentation, vascularity, pliability, and height for a total of 13 points. Normal appearance in each of the parameters garners a score of 0 and scores get higher (2-3) as an increase in parameters is observed. The lower the score, the better the outcome.|Assessed up to 1 month of use||||units on a scale||Standard Deviation|Mean
1308490|NCT02642679|Primary|Wound Healing Rate (Re-epithelialization)|The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively.|Assessed up to 1 month postoperatively.||||percent (%)||Standard Deviation|Mean
1308506|NCT02642432|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1308491|NCT02642679|Primary|Pain|Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity.|Assessed up to 14 days of use|Pain was evaluated on postoperative day 1, before the dressing was changed on days 5-7, and before and after dressing removal on days 10-14 using the Visual Analog Scale (VAS). The patient was asked to mark his/her pain level on the line between the two endpoints.|||units on a scale||Standard Deviation|Mean
1308492|NCT02642575|Secondary|The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done.~Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle including the volume-based diameter (dV) of the follicle.~The volume calculation is based on the voxel count within the identified follicle. It therefore represents a true measure of follicular volume."|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.|||mm^3||Standard Deviation|Mean
1308493|NCT02642575|Secondary|The Mean Follicular Diameter by Five-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done.~Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD)"|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.|||mm||Standard Deviation|Mean
1308494|NCT02642575|Primary|The Mean Follicular Diameter by Two-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Two Dimensional Ultrasound was done.~Each follicle was assessed by measuring the maximal diameters on three orthogonal planes.~The mean of three diameters was calculated."|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.|||mm||Standard Deviation|Mean
1308495|NCT02642536|Secondary|Assessing PTSD Symptom Severity|PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.|baseline||||units on a scale||Standard Deviation|Mean
1308496|NCT02642536|Secondary|Assessing Anxiety Symptom Severity|Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.|baseline||||units on a scale||Standard Deviation|Mean
1308497|NCT02642536|Secondary|Assessing Depression Symptom Severity|Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.|baseline||||units on a scale||Standard Deviation|Mean
1308498|NCT02642536|Secondary|Assessing PTSD Symptom Severity|PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.|16 weeks||||units on a scale||Standard Deviation|Mean
1308499|NCT02642536|Secondary|Assessing Anxiety Symptom Severity|Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.|16 weeks||||units on a scale||Standard Deviation|Mean
1308500|NCT02642536|Secondary|Assessing Depression Symptom Severity|Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.|16 weeks|frequency analysis|||units on a scale||Standard Deviation|Mean
1308501|NCT02642536|Primary|Self Efficacy for Practicing Good Dietary Habits|Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales|16 weeks||||units on a scale||Standard Deviation|Mean
1308502|NCT02642536|Primary|Self Efficacy for Practicing Good Dietary Habits|Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales|baseline||||units on a scale||Standard Deviation|Mean
1308503|NCT02642536|Primary|Number of Days Engaged in Vigorous Activity|Initial assessment of vigor and time spent on physical activity minimum-maximum total score range (0-32) Higher value represents more days spent performing vigorous physical activity The score was obtained from a single item|baseline||||days spent performing vigorous activity||Standard Deviation|Mean
1308504|NCT02642536|Primary|Number of Days Engaged in Vigorous Activity|changes in vigor and time spent on physical activity practice will be measured by the MOVE! 11 assessment at post treatment (16 weeks) minimum-maximum total score range (0-48) Higher value represents more days spent performing vigorous activity|16 weeks||||days spent performing vigorous activity||Standard Deviation|Mean
1308505|NCT02642536|Primary|MOVE! Attendance|Number of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item|16 weeks||||number of sessions||Standard Deviation|Mean
1308507|NCT02642432|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1308508|NCT02642432|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1308509|NCT02642159|Secondary|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis|Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value.|Baseline, Week 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||Glucose lowering treatments||Standard Deviation|Mean
1308510|NCT02642159|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis|Absolute change = FPG value at specified week minus FPG value at baseline.|Baseline, Week 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
1308511|NCT02642159|Secondary|Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis|Absolute change = HbA1c value at specified week minus HbA1c value at baseline.|Baseline, Week 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||mmol/mol||Standard Deviation|Mean
1308512|NCT02642159|Secondary|Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|LDL-C particle number ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308513|NCT02642159|Secondary|Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis|LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle number on- or off-treatment (LDL-C particle number ITT population).|||Percent change||Standard Error|Least Squares Mean
1308514|NCT02642159|Secondary|Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|HDL-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308515|NCT02642159|Secondary|Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||Percent change||Standard Error|Least Squares Mean
1308516|NCT02642159|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Mean
1308517|NCT02642159|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||Percent change||Standard Error|Mean
1308518|NCT02642159|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Mean
1308519|NCT02642159|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||Percent change||Standard Error|Mean
1308520|NCT02642159|Secondary|Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|Total-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308521|NCT02642159|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||Percent change||Standard Error|Least Squares Mean
1308522|NCT02642159|Secondary|Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|Apo-B ITT population.Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308523|NCT02642159|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population).|||Percent change||Standard Error|Least Squares Mean
1308524|NCT02642159|Secondary|Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|LDL-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308525|NCT02642159|Secondary|Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|LDL-C ITT population.|||Percent change||Standard Error|Least Squares Mean
1308526|NCT02642159|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308527|NCT02642159|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||Percent change||Standard Error|Least Squares Mean
1308528|NCT02642159|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|LDL-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308529|NCT02642159|Secondary|Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C value on-or off-treatment (LDL-C ITT population).|||Percent change||Standard Error|Least Squares Mean
1308530|NCT02642159|Primary|Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1308531|NCT02642159|Primary|Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||Percent change||Standard Error|Least Squares Mean
1308664|NCT02638493|Primary|Semen Clearance (CL) of Tenofovir Diphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from seminal mononuclear cells, following a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||fmol/10x6 cells||Inter-Quartile Range|Median
1308532|NCT02641912|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events on administration of investigational product from screening (Day 1) to 5 days after last administration of the product on Day 8. Number of participants with TEAEs were reported.|up to 13 days|Analysis for this outcome was conducted on safety population which included all participants who were randomized and received at least one dose of study treatment during the study.|||Number of participants|||Number
1308533|NCT02641912|Secondary|Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8|Participants answered 4 questions on PPUSQ as follows: Q1:Which of the following statements best describes how much you liked the product overall?(rated on scale of 1-6, 1=Did not like it at all; 2=Did not like it that much; 3=Like it slightly; 4=Like it somewhat; 5=Like it very much; 6=Like it extremely), Q2:How pleasant would you say the flavor of the product was?(rated on scale of 1-5, 1=Not pleasant at all; 2=Slightly pleasant; 3=Moderately pleasant; 4=Very pleasant; 5=Extremely pleasant), Q3:How gentle would you say the product was?(rated on a scale of 1-7, 1=Not gentle at all; 2=Barely gentle; 3=Slightly gentle; 4=Moderately gentle; 5=Very gentle; 6=Extremely gentle; 7=The most gentle product imaginable), Q4:How fresh would you say your mouth felt after using the product?(rated on a scale of 1-5; 1=Not at all fresh; 2=Not very fresh; 3=Somewhat fresh; 4=Very fresh; 5=Extremely fresh) & response to these questions was reported. Scale score was averaged to calculate the response|Day 1, Day 3, Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||score on a scale||Standard Error|Least Squares Mean
1308534|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It’s a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life. Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1:Uncomfortable; M2:Bad taste; M3:Loss of Taste; M4:Lips sticking to roof of mouth; M5:Tongue sticking to roof of mouth; M6: Throat dry; M7:No moisture; M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308535|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8|Number of participants were reported who answered following questions, these questions are about how you have coped with your dry mouth over last week. Please tell us whether you agree or disagree with each of the statements. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, There are other things that help some people with dry mouth. Please tell us how often over last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308536|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8|Number of participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people’s moods and emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over the last week Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, and How much do you agree or disagree that your dry mouth has affected your time with other people over last week? Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308537|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8|Number of participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem?; Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, and How much do you recognize yourself in following statements, based on last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308668|NCT02638259|Secondary|Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel|Frequency of participants with injection site reactions in GP2015 and Enbrel|Treatment Period 1, 24 weeks|Safety Set|||Participants|||Count of Participants
1308538|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It’s a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life; Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1: Uncomfortable; M2: Bad taste; M3:Loss of Taste; M4: Lips sticking to roof of mouth; M5: Tongue sticking to roof of mouth; M6: Throat dry; M7: No moisture M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308539|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1|Number of participants were reported who answered following questions, these questions were about how participants had coped with their dry mouth over the last week with respect to agree or disagree with each of the following questions. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to the toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, and There are other things that help some people with dry mouth. Please tell us how often over the last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308540|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1|Number of Participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people’s moods & emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over last week; Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, How much do you agree or disagree that your dry mouth has affected your time with other people over the last week?; Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone; Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308541|NCT02641912|Secondary|Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1|Number of Participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem? Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, How much do you recognize yourself in following statements, based on the last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
1308542|NCT02641912|Secondary|Mean Response to SAoP QoL 2 Prior to Treatment on Day 8|Participants answered to the 6 questions in SAoP QoL 2 as follows: Q1= Looking back over the last 7 days, has your dry mouth caused discomfort?; Q2= Looking back over the last 7 days, has your dry mouth made it uncomfortable to speak?; Q3= Looking back over the last 7 days, has your dry mouth interrupted your sleep?; Q4= Looking back over the last 7 days, has your dry mouth affected your social interactions?; Q5= Looking back over the last 7 days, has your dry mouth caused you to avoid certain foods?; Q6= Looking back over the last 7 days, has your dry mouth interfered with your daily activities? These questions were rated on scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1308543|NCT02641912|Secondary|Mean Response to Subjective Assessment of Patient’s Quality of Life (SAoP QoL1) Prior to Treatment on Day 1|Participants answered to the 6 questions in SAoP QoL as follows: Q1= Does your dry mouth cause discomfort?; Q2= Does your dry mouth make it uncomfortable to speak?; Q3= Does your dry mouth interrupt your sleep?; Q4= Does your dry mouth affect your social interactions?; Q5= Does your dry mouth cause you to avoid certain foods?; Q6= Does your dry mouth interfere with your daily activities? These questions were rated on a scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1314905|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN||96 weeks||||participants|participants||Number
1308544|NCT02641912|Secondary|Mean Response to PPAQ4 Prior to Treatment on Day 3|Participants answered to the 9 questions in PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|Prior to treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308545|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308546|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308547|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3|Participants answered the 14 questions of PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308548|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3|Participants answered to the 11 questions in PPAQ2 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308549|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3|Participants answered to the 3 questions in PPAQ1 as follows: Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308585|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)|Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.|Baseline (Day 1)|The ITT population included all participants randomized and allocated to receive treatments.|||Number of participants|||Number
1308550|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308551|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308552|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308553|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1|Participants answered to the 11 question in PPAQ2. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308554|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1|Participants answered to the 3 question in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308555|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8|Participants answered the 9 questions of PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308604|NCT02640482|Secondary|Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value of post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to Week 12 post baseline|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants||95% Confidence Interval|Number
1308556|NCT02641912|Secondary|Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308557|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308558|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308559|NCT02641912|Secondary|Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8|Participants answered questions, Q2-Q11 in PPAQ2. Q2=Feeling comfortable in the mouth; Q3=Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q=9 Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on a scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308560|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8|Participants answered 3 questions in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308561|NCT02641912|Secondary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8|Participants answered to the question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 and 240 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308562|NCT02641912|Secondary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8|Participants answered to the question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ2 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1314906|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN||96 weeks||||participants|participants||Number
1308563|NCT02641912|Primary|Mean Response to the Question 1 ‘Relieving the Discomfort of Dry Mouth’ in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8|Participants answered question 1 ‘Relieving the discomfort of dry mouth’ in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 8|Intent-to-treat (ITT) population which included all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
1308564|NCT02641561|Secondary|The Number of Participants Who Were Readmitted After ERCP as Assessed by Medical Record and Patients Self-reporting||30 days after ERCP||||Participants|||Count of Participants
1308565|NCT02641561|Secondary|The Length of Stay (LOS) of Participants After ERCP if Medical Care is Sought as Assessed in Days||30 days after ERCP||||days||Standard Deviation|Mean
1308566|NCT02641561|Secondary|The Number of Participants With Post-procedural Medical Care (ED Visit, Urgent Care, Hospitalization) as Assessed by Medical Record and Patients Self-reporting||30 days after ERCP||||Participants|||Count of Participants
1308567|NCT02641561|Secondary|The Number of Participants With Mortality After ERCP as Assessed by Medical Record Reporting||30 days after ERCP||||Participants|||Count of Participants
1308568|NCT02641561|Secondary|The Number of Participants Who Undergo Surgery After ERCP, as Assessed by Surgical Operative Report||30 days after ERCP||||Participants|||Count of Participants
1308569|NCT02641561|Secondary|The Number of Participants With Perforation After ERCP as Assessed by Abdominal Imaging Suggestive of Perforation|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
1308570|NCT02641561|Secondary|The Number of Participants With Pancreatic Abscess After ERCP as Assessed by Abdominal Imaging Suggestive of Pancreatic Abscess|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
1308571|NCT02641561|Secondary|The Number of Participants With Pancreatic Pseudocyst After ERCP as Assessed by Abdominal Imaging Suggestive of Pseudocyst|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
1308572|NCT02641561|Secondary|The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated International Normalized Ratio (INR)|INR > 1.5|30 days after ERCP||||Participants|||Count of Participants
1308573|NCT02641561|Secondary|The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated Creatinine Blood Test|creatinine > 1.5 milligrams/deciliter (mg/dL)|30 days after ERCP||||Participants|||Count of Participants
1308574|NCT02641561|Secondary|The Number of Participants With Sepsis After ERCP as Assessed by Infectious Source Defined by Positive Microbiology Culture|positive blood culture|30 days after ERCP||||Participants|||Count of Participants
1308575|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|> 10% immature neutrophils (band forms).|30 days after ERCP||||Participants|||Count of Participants
1308576|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|white blood cell (WBC) count < 4000 cells/mm³ (4 x 109 cells/L)|30 days after ERCP||||Participants|||Count of Participants
1308577|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|Temperature < 36°C(96.8°F) or > 38°C(100.4°F)|30 days after ERCP||||Participants|||Count of Participants
1308578|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|PaCO2 < 4.3 kilopascal (kPa) (32 mmHg)|30 days after ERCP||||Participants|||Count of Participants
1308579|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|Respiratory rate > 20 breaths per minute|30 days after ERCP||||Participants|||Count of Participants
1308580|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|Heart rate > 90 beats per minutes|30 days after ERCP||||Participants|||Count of Participants
1308581|NCT02641561|Secondary|The Number of Participants With Acute Respiratory Distress Syndrome (ARDS) After ERCP as Assessed by ARDSnet Criterion (Below)|bilateral opacities on chest imaging not explained by other lung pathology, respiratory failure not explained by heart failure or volume, and overload and a pulmonary arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio under 300, PaO2/FiO2 ratio is the partial pressure arterial oxygen and fraction of inspired oxygen|30 days after ERCP||||Participants|||Count of Participants
1308582|NCT02641561|Primary|The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
1308583|NCT02641561|Primary|The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal|amylase or lipase|30 days after ERCP||||Participants|||Count of Participants
1308584|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 2)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.|||Number of participants|||Number
1312716|NCT02500368|Secondary|Post-blink Movement|Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)|Baseline and 1 week||||mm steps||Standard Deviation|Mean
1308586|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)|The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed for a given time point.|||scores on a scale||Standard Deviation|Mean
1308587|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)|The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.|||scores on a scale||Standard Deviation|Mean
1308588|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)|The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
1308589|NCT02641379|Secondary|Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)|ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
1308590|NCT02641379|Secondary|Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)|Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
1308591|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 1)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.|||Number of participants|||Number
1308592|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)|Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.|Baseline (Day 1)|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.|||Number of participants|||Number
1308593|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)|The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.|||scores on a scale||Standard Deviation|Mean
1308625|NCT02639637|Secondary|Insulin|Plasma insulin measured by radioimmunoassay.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days 1 and 2 were separated by five weeks, a four-week washout and one-week treatment period.|The comparison of sitagliptin and placebo were original to the study. Because the purpose of the sitagliptin and valsartan versus placebo and valsartan comparison was to further understand the mechanism for forearm blood flow effects it was not necessary to measure insulin in that added part of the study.|||microU/mL||Standard Deviation|Mean
1308594|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)|The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.|||scores on a scale||Standard Deviation|Mean
1308595|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)|The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
1308596|NCT02641379|Secondary|Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)|End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
1308597|NCT02641379|Primary|Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)|The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.|||Percentage of participants||95% Confidence Interval|Number
1308598|NCT02641379|Primary|Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)|Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.|||Percentage of participants||95% Confidence Interval|Number
1308599|NCT02641249|Secondary|Change in the Total Number of Bradycardia Episodes (<100 Beats Per Minute (Bpm), at Least 5 Seconds Long) During Intervention and Without the Intervention|The total number of bradycardia episodes to <100 bpm lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity|||bradycardias||Standard Error|Mean
1308600|NCT02641249|Secondary|Change in the Total Number of Intermittent Hypoxic Episodes to <90% Lasting >5 Seconds/Episode During the Intervention and Without Intervention|The total number of intermittent hypoxic episodes to <90% (pulse oximetry) lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity|||IH events||Standard Error|Mean
1308601|NCT02641249|Primary|Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention|The total number of apneas/breathing pauses will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity|||breathing pauses||Standard Error|Mean
1308602|NCT02640482|Secondary|Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of active study drug.|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB with prior SOF + RBV ± pegIFN failures.|||percentage of participants|||Number
1308603|NCT02640482|Secondary|Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of DB treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|Between End of Treatment (Week 12) and 12 weeks after the last dose of Arm A DB active drug (up to Week 24)|All randomized participants who received at least 1 dose of study drug in Arm A DB with HCV RNA < LLOQ at the final treatment visit who completed the DB treatment, excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants||95% Confidence Interval|Number
1308605|NCT02640482|Secondary|Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The secondary efficacy endpoint was the superiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior SOF + RBV ± pegIFN failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks). As pre-specified in the study protocol, the primary outcome measure and the secondary outcome measure are not tested independently from each other. Rather, the two measures are ranked in a fixed sequential testing procedure that only if success was demonstrated for the primary outcome (i.e. non-inferiority test of Arm A SVR12 rate to the standard of care) did we test the first secondary outcome (i.e. superiority test of Arm A SVR12 rate to the standard of care).|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants|||Number
1308606|NCT02640482|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was the noninferiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylatedinterferon (pegIFN) failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks).|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants|||Number
1308607|NCT02640404|Primary|Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)|Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.4 degree Celsius; Grade 2: >=38.5 degree Celsius to <=38.9 degree Celsius; Grade 3: >=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.|Within 7 days post-vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
1308608|NCT02640404|Primary|Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)|Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.5 degree Celsius; Grade 2: >38.5 degree Celsius to <=39.5 degree Celsius; Grade 3: >39.5 degree Celsius), Vomiting (Grade 1: 1 episode per 24 hours, Grade 2: 2-5 episodes per 24 hours, Grade 3: >=6 episodes per 24 hours), Crying abnormal (Grade 1: <1 hour; Grade 2: 1-3 hours; Grade 3: >3 hours), Drowsiness (Grade 1: sleepier than usual or less interested in surroundings; Grade 2: Not interested in surroundings or did not wake up for a feed / meal; Grade 3: Sleeping most of the time or difficult to wake up), Appetite loss (Grade 1: eating less than normal; Grade 2: missed 1 or 2 feeds / meals completely; Grade 3: refuses >=3 feeds / meals or refuses most feeds / meals), Irritability (Grade 1: easily consolable; Grade 2: requiring increased attention; Grade 3: inconsolable). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.|Within 7 days post-vaccination 1, Within 7 days post-vaccination 2|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
1308609|NCT02640404|Primary|Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)|Solicited injection (Inj.) site reactions in children (2-11 years), adolescents and adults (12-55 years): Tenderness/Pain (Grade 1: easily tolerated [children], no interference with activity [adolescents and adults]; Grade 2: sufficiently discomforting [children], some interference[adolescents and adults]; Grade 3: unable to perform usual activities[children]; significant interference with daily activities [adolescents and adults]), Erythema and Swelling (Grade 1: >0 to<25 mm [children], >=25 to <=50 mm [adolescents and adults]; Grade 2: >=25 to <50 mm [children], >=51 to <=100 mm [adolescents and adults], Grade 3: >=50 mm [children]; >100 mm[adolescents and adults]). Number of participants with any of Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.|Within 7 days post-vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
1308610|NCT02640404|Primary|Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)|Solicited injection (Inj.) site reactions: Tenderness/Pain (Grade 1: minor reaction when Inj. site touched; Grade 2: cries/protests when Inj. site touched; Grade 3: cries when injected limb moved, or the movement of the injected limb is reduced), Erythema and Swelling (Grade 1: >0 to <25 mm, Grade 2: >=25 to <50 mm, Grade 3: >=50 mm). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.|Within 7 days post-vaccination 1, Within 7 days post-vaccination 2|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
1308611|NCT02640157|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit|||percentage of participants||95% Confidence Interval|Number
1308612|NCT02640157|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population)|||percentage of participants||95% Confidence Interval|Number
1308613|NCT02640157|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Per statistical analysis plan to adjust for multiplicity among the primary and first secondary hypothesis tests, the test for superiority of Arm A to Arm B was not conducted.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1308614|NCT02640157|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. If the first primary efficacy objective (noninferiority of Arm A to Arm B) was achieved, then the second primary efficacy objective, noninferiority in the percentage of participants achieving SVR12 of the 8-week regimen (Arm C) to the 12-week regimen (Arm A) was to be tested. Noninferiority was defined as: a) the lower bound of the 95% CI for the difference was above the noninferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was greater than 92%, OR b) the lower bound of the 95% CI for the difference was below the noninferiority margin of –6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm C was greater than 92%, OR c) the lower bound of the 97.5% CI for the difference was above the noninferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was below 92%.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1308615|NCT02640157|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ] 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority in the percentage of participants achieving SVR12 of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir [SOF] + daclatasvir [DCV]), defined as: a) the lower bound of the 95% confidence interval (CI) for the difference was above the non-inferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was greater than 92%; OR b) the lower bound of the 95% CI for the difference was below the non-inferiority margin of –6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm A was greater than 92%; OR c) the lower bound of the 97.5% CI for the difference was above the non-inferiority margin of –6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was below 92%.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1308616|NCT02639637|Secondary|Heart Rate||Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||beats per minute||Standard Deviation|Mean
1308617|NCT02639637|Secondary|Mean Arterial Pressure||Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||mm Hg||Standard Deviation|Mean
1308618|NCT02639637|Secondary|Venous tPA|Measured using an ELISA. This was measured in a few subjects. After it was determined that there was no change in net t-PA release it was not measured in the remainder.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|This was measured in a few subjects. After it was determined that there was no change in net t-PA release it was not measured in the remainder.|||ng/mL||Standard Deviation|Mean
1308619|NCT02639637|Secondary|Arterial tPA|Measured using an ELISA.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|This was measured in a few subjects. After it was determined that there was no change in net t-PA release it was not measured in the remainder.|||ng/mL||Standard Deviation|Mean
1308620|NCT02639637|Secondary|Low Frequency Variability of Blood Pressure Activity|Measured using the VITAL-GARD 450c monitor Ivy Biomedical Systems, Branford, CT, USA)|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||mm Hg2||Standard Deviation|Mean
1308621|NCT02639637|Secondary|DPP4 Activity|DPP4 activity was measured by detection of cleavage of a colorimetric substrate.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||nmol/ml/min||Standard Deviation|Mean
1308622|NCT02639637|Secondary|ACE Activity|ACE activity was measured using a commercially available assay (Olympus AU400/AU600, Alpco Diagnotics, Salem, NH.) The lower level of detection was 15 U/L and values below the level of detection were reported at half the level of detection.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|Was not measured during the valsartan study days.|||U/L||Standard Deviation|Mean
1308623|NCT02639637|Secondary|Glucose|Glucose was measured by the glucose oxidase method using a YSI glucose analyzer|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||mg/dL||Standard Deviation|Mean
1308624|NCT02639637|Secondary|GLP-1|GLP--1 was not analyzed as subjects were studied in the fasting state.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|GLP--1 was not analyzed as subjects were studied in the fasting state.||||||
1308647|NCT02639338|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the study drug|||percentage of participants||95% Confidence Interval|Number
1308626|NCT02639637|Secondary|NPY Metabolites|"NPY (3-36) concentration measured by micro ultra-hgih pressure liquid chromatography tandem mass spectrometry.~NPY (3-36) is the degradation product of NPY by dipeptidyl peptidase 4. It was measured only in the diabetics studied."|Measured after 5 min infusion of the 1.0 nmol/min dose of neuropeptide Y on study days 1 and 2. Study days 1 and 2 were separated by five weeks.|Because the purpose of measuring NPY metabolites was to assess whether sitagliptin blocks the formation of the metabolites, and because the analysis is laborious and costly, measurements were only completed in the diabetics studied.|||pmol/L||Standard Deviation|Mean
1308627|NCT02639637|Secondary|Venous Norepinephrine|Venous norepinephrine concentration measured by high-performance liquid chromatography|Measured at baseline (time 0) prior to the infusion of neuropeptide Y on each study day. Study days 1 and 2 were separated by five weeks.||||pg/mL||Standard Deviation|Mean
1308628|NCT02639637|Secondary|Arterial Norepinephrine|Arterial norepinephrine concentration measured by high-performance liquid chromatography.|Measured at baseline (time 0) prior to the infusion of neuropeptide Y on each study day. Study days 1 and 2 were separated by five weeks.||||pg/mL||Standard Deviation|Mean
1308629|NCT02639637|Primary|Forearm Blood Flow|Forearm blood flow measured by strain gauge plethysmography in response to 1.0 nmol/min neuropeptide Y, the highest dose that all received.|FBF measured after 5 min of the 1 nmol/min dose of neuropeptide Y on study days 1 and 2. Study days 1 and two were separated by five weeks.||||mL/min/100 mL||Standard Deviation|Mean
1308630|NCT02639494|Other Pre-specified|Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors|All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form|72 hours post-procedure||||Device|Device||Count of Units
1308631|NCT02639494|Other Pre-specified|Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject||72 hours post-procedure||||Participants|||Count of Participants
1308632|NCT02639494|Other Pre-specified|Any Device-related Adverse Event||72 hours post-procedure||||Participants|||Count of Participants
1308633|NCT02639494|Other Pre-specified|Death, All-cause, Cardiovascular, and Non-cardiovascular||72 hours post-procedure||||Participants|||Count of Participants
1308634|NCT02639494|Other Pre-specified|Number of Participants With Cardiac Tamponade||72 hours post-procedure||||Participants|||Count of Participants
1308635|NCT02639494|Other Pre-specified|Number of Participants With Stroke||72 hours post-procedure||||Participants|||Count of Participants
1308636|NCT02639494|Other Pre-specified|Number of Self-Centering Guide Catheters With Device Success|Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form.|Through study completion, up to 72 hours post-procedure||||Device|Device||Count of Units
1308637|NCT02639494|Other Pre-specified|Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System|The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.|Through study completion, up to 72 hours post-procedure||||Device|Device||Count of Units
1308638|NCT02639494|Other Pre-specified|Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire||Through study completion, up to 72 hours post-procedure||||Attempts|Device|95% Confidence Interval|Mean
1308639|NCT02639494|Other Pre-specified|Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body||Through study completion, up to 72 hours post-procedure|A guide wire was delivered through the self-centering guide catheter in 18/20 patients. In total 23 devices were used.|||minutes|Devices|95% Confidence Interval|Mean
1308640|NCT02639494|Other Pre-specified|Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve||Through study completion, up to 72 hours post-procedure|A guide wire was delivered through the self-centering guide catheter in 18/20 patients.|||minutes||95% Confidence Interval|Mean
1308641|NCT02639494|Primary|Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle|This outcome will be assessed via physician determination and will be recorded in the case report form.|Through study completion, up to 72 hours post-procedure|20 patients were treated with 23 devies|||Device|Device||Count of Units
1308642|NCT02639338|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1308643|NCT02639338|Secondary|Change From Baseline in HCV RNA||Weeks 1, 2, 4, 8 and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1308644|NCT02639338|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 1, 2, 4, 8 and 12|Percentage of participants in Full Analysis Set with on-treatment data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1308645|NCT02639338|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1308646|NCT02639338|Primary|Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1308648|NCT02639247|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1308649|NCT02639247|Secondary|Change From Baseline in HCV RNA||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1308650|NCT02639247|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 1, 2, 4, 8 and 12|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1308651|NCT02639247|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participcants||95% Confidence Interval|Number
1308652|NCT02639247|Primary|Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1308653|NCT02639247|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized or enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1308654|NCT02639052|Secondary|Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment|A secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. The pain VAS intensity scale ranges from a minimum of 0 (no pain - best) to a maximum of 10 (maximum pain - worst). Participants will rate pain intensity after pain is induced with a heat thermode.|Baseline, 1 week, 1 month, 3 months||||units on a scale||Standard Deviation|Mean
1308655|NCT02639052|Primary|Itch by VAS Itch Intensity at 3 Months (Visit 4)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|3 Months from Baseline||||units on a scale||Standard Deviation|Mean
1308656|NCT02639052|Primary|Itch by VAS Itch Intensity at 1 Month (Visit 3)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|1 Month from Baseline||||units on a scale||Standard Deviation|Mean
1308657|NCT02639052|Primary|Itch by VAS Itch Intensity at 1 Week (Visit 2)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|1 week from Baseline||||units on a scale||Standard Deviation|Mean
1308658|NCT02639052|Primary|Itch by VAS Itch Intensity at Baseline (Visit 1)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|Baseline (Visit 1)||||units on a scale||Standard Deviation|Mean
1308659|NCT02638493|Secondary|Emtricitabine Triphosphate (FTCtp)/Deoxyadenosine Triphosphate (dCTP) Ratio in Seminal Mononuclear Cells|dCTP concentrations in seminal mononuclear cells will be measured and compared to emtricitabine triphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.|Average concentration in a 24 hour dosing interval||||FTCtp:dCTP ratio||Inter-Quartile Range|Median
1308660|NCT02638493|Secondary|Tenofovir Diphosphate (TFVdp)/Deoxyadenosine Triphosphate (dATP) Ratio in Seminal Mononuclear Cells|dATP concentrations in seminal mononuclear cells will be measured and compared to tenofovir diphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.|Average concentration in a 24 hour dosing interval||||TFVdp:dATP ratio||Inter-Quartile Range|Median
1308661|NCT02638493|Primary|Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Emtricitabine Triphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from peripheral blood mononuclear cells, following a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||fmol/10 E6 cells||Inter-Quartile Range|Median
1308662|NCT02638493|Primary|Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Tenofovir Diphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from peripheral blood mononuclear cells, following a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||fmol/10 E6 cells||Inter-Quartile Range|Median
1308663|NCT02638493|Primary|Semen Clearance (CL) of Emtricitabine Triphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from seminal mononuclear cells, following a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|Semen (SMC) Steady State Concentrations (Css,ave) of Emtricitabine Triphosphate|||fmol/10 E6 cells||Inter-Quartile Range|Median
1343464|NCT01898208|Secondary|Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment||3 Days after enrollment||||participants|||Number
1308669|NCT02638259|Primary|Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel|"Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity.~A DAS28-CRP value >5.1 corresponds to a high disease activity~A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity~A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity~A DAS28-CRP value < 2.6 corresponds to remission DAS28-CRP = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GDA + 0.96 where~tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count~CRP is C-reactive protein (mg/l)~GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm"|24 weeks|Treatment Period 1 Per-Protocol set|||scores on a scale||Standard Error|Least Squares Mean
1308670|NCT02638129|Secondary|Time From Treatment Period Randomization to the Occurrence of Cardiovascular Death||Day 1 to the occurrence of cardiovascular death (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
1308671|NCT02638129|Secondary|Time From Treatment Period Randomization to the Occurrence of All-Cause Death||Day 1 to the occurrence of all-cause death (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
1308672|NCT02638129|Secondary|Time From Treatment Period Randomization to the First Confirmed Occurrence of Extended Major Adverse Cardiovascular Events (MACE)|Extended MACE defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina requiring hospitalization.|Day 1 to first confirmed occurrence of extended MACE (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
1308673|NCT02638129|Primary|Time From Treatment Period Randomization to the First Confirmed Occurrence of Major Adverse Cardiovascular Events (MACE)|MACE are defined as cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.|Day 1 to first confirmed occurrence of MACE (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
1308674|NCT02638051|Secondary|Quality of Life (QoL)|"Karnofsky Performance Score Improvement Rate (KPS IR)~Improvement: increase of KPS for ≥10% after treatment.~Worsening: reduction of KPS for ≥10% after treatment.~NC: change of KPS for <10%."|8 weeks after start of treatment (4 weeks on completion of treatment)||||percentage of participants|||Number
1308675|NCT02638051|Secondary|Adverse Events Rate (AER)|Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.|During 4 weeks of treatment course and 4 weeks after treatment||||participants|||Number
1308676|NCT02638051|Primary|Objective Response Rate (ORR)|"Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR)~WHO criteria of therapeutic effect evaluation at malignant ascites:~Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month.~Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month.~No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention."|8 weeks after start of treatment (4 weeks on completion of treatment)||||percentage of participants|||Number
1308677|NCT02637999|Secondary|Number of Participants With Covalently Closed Circular Deoxyribonucleic Acid (cccDNA) Response at Week 72 of Therapy|Virological cccDNA response was defined as reduction of intrahepatic cccDNA by 0.5 log in comparison to baseline at the end of follow up.|Baseline and 72 weeks for arm A and 48 weeks for arms B and C|No data to be reported due to absence of biopsy data. Biopsy data are unavailable because analyses were not performed||||||
1308678|NCT02637999|Secondary|Number of Participants With Biochemical Response at Week 24 of Therapy|Biochemical response was defined as normalization of ALT level as compared to baseline.|Baseline and 24 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
1308679|NCT02637999|Secondary|Number of Participants With Biochemical Response at Week 12 of Therapy|Biochemical response was defined as normalization of ALT level as compared to baseline.|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
1308680|NCT02637999|Secondary|Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy|HDV RNA response was defined as persistent reduction of HDV RNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 24 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
1308681|NCT02637999|Secondary|Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy|HDV RNA response was defined as persistent reduction of HDV RNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
1308682|NCT02637999|Secondary|Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy|HBV DNA response was defined as persistent reduction of HBV DNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
1308683|NCT02637999|Secondary|Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy|HBV DNA response was defined as persistent reduction of HBV DNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 24 weeks||||Participants|||Count of Participants
1308684|NCT02637999|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy|HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 24 compared to baseline (including the patient with negative baseline level)|Baseline and 24 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
1308685|NCT02637999|Primary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy|HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 12 compared to baseline (including the patient with negative baseline level)|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
1308686|NCT02637804|Secondary|Papillary Conjunctivitis|Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
1308687|NCT02637804|Secondary|Corneal Oedema|Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
1308688|NCT02637804|Secondary|Conjunctival Staining|Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
1308689|NCT02637804|Secondary|Corneal Neovascularization|Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
1308690|NCT02637804|Secondary|Corneal Staining|Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
1308691|NCT02637804|Secondary|Limbal Redness|Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
1308692|NCT02637804|Secondary|Conjunctival Redness|Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
1308693|NCT02637804|Secondary|Lens Fit Overall|Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))|1 week||||Eyes|Eyes||Number
1308694|NCT02637804|Secondary|Lens Fit Overall|Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))|Baseline||||Eyes|Eyes||Number
1308695|NCT02637804|Secondary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)|1 week||||Eyes|Eyes||Number
1308696|NCT02637804|Secondary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)|Baseline||||Eyes|Eyes||Number
1308697|NCT02637804|Secondary|Lens Fit - Vertical Centration|Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)|1 week||||Eyes|Eyes||Number
1308698|NCT02637804|Secondary|Lens Fit - Vertical Centration|Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)|Baseline||||Eyes|Eyes||Number
1308699|NCT02637804|Secondary|Lens Fit - Horizontal Centration|Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)|1 week||||Eyes|Eyes||Number
1308700|NCT02637804|Secondary|Lens Fit - Horizontal Centration|Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)|Baseline||||Eyes|Eyes||Number
1308701|NCT02637804|Primary|Lens Preference - Stenfilcon A/Delefilcon A (Group 2)|Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).|1 week||||Participants|||Count of Participants
1308702|NCT02637804|Primary|Lens Preference - Stenfilcon A/Narafilcon A (Group 1)|Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).|1 week||||Participants|||Count of Participants
1308703|NCT02637804|Primary|Handling|Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.|1 week||||units on a scale||Standard Deviation|Mean
1308704|NCT02637804|Primary|Vision|Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).|1 week||||units on a scale||Standard Deviation|Mean
1308705|NCT02637804|Primary|Comfort|Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).|1 week||||units on a scale||Standard Deviation|Mean
1308706|NCT02637804|Primary|Dryness|Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.|1 week||||units on a scale||Standard Deviation|Mean
1308707|NCT02637804|Primary|Red Eye Sensation|Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week||||Eyes|Eyes||Number
1308708|NCT02637804|Primary|Itching Sensation on Removal|Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week||||Eyes|Eyes||Number
1308709|NCT02637804|Primary|Pain and Foreign Body Sensation|Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week||||eyes|Eyes||Number
1308710|NCT02637323|Other Pre-specified|Plasma Pharmacokinetic Parameters for FX006 and TCA IR||Up to 20 Weeks|||||||
1308711|NCT02637323|Secondary|Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort|All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.|Up to 20 Weeks|All patients who received study drug and had at least one post-baseline plasma sample obtained and assayed for drug concentration levels.|||pg/mL||95% Confidence Interval|Geometric Mean
1308712|NCT02637323|Primary|Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid|All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).|Up to 20 Weeks|All patients who received study drug and had synovial fluid obtained at the Synovial Fluid Visit and assayed for drug concentration levels.|||pg/mL||95% Confidence Interval|Geometric Mean
1308713|NCT02637063|Secondary|Self-reported Self-efficacy for Lifestyle Behaviors|Five items assessed participants’ confidence to engage in JNC-recommended healthy behaviors using a 5-item response option (1=not at all confident (min), 5=very confident (max)). Mean score is reported, with higher scores indicating higher self-efficacy. The scale showed good reliability (alpha=.79).|Baseline, 12 weeks, 24 weeks||||units on a Likert-type scale||Standard Deviation|Mean
1308714|NCT02637063|Secondary|Self-reported Lifestyle Change Preparation Behaviors|Participants were asked to self-report on days in the past two weeks in which they engaged in specific behaviors to prepare for or support healthy eating and physical activity (i.e., “preparation behaviors”). The scale comprised 15 items (e.g., thought about what you might do to try to lose weight) assessed on a 5-point scale (1=none (min), 5=12-14 days (max)). Mean score is reported, with higher scores indicating more frequent preparation behaviors. The scale showed good reliability (alpha=.91).|Baseline, 12 weeks, 24 weeks||||units on a Likert scale||Standard Deviation|Mean
1308715|NCT02637063|Primary|Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)|Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-unhealthy foods (red, processed and high-fat prepared meats).|Baseline, 12 weeks, 24 weeks||||Servings||Standard Deviation|Mean
1308716|NCT02637063|Primary|Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)|Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-healthy foods (fruits, vegetables and lean meats).|Baseline, 12 weeks, 24 weeks||||Servings||Standard Deviation|Mean
1308717|NCT02637063|Primary|Body Weight|Body weight measurements were taken by participants using a validated, WIFI-enabled weight scale manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants were instructed to take weight measurements at the same time of day each time, preferably first thing in the morning after using the bathroom and before eating or drinking. The weight measurement taken on the date and time closest to the completion date and time of each individual’s online survey for that assessment point was analyzed. If no measurements were available within two weeks on either side of that date, weight measurements were considered missing for that assessment period.|Baseline, 12 weeks, 24 weeks||||Pounds||Standard Deviation|Mean
1308718|NCT02637063|Primary|Diastolic Blood Pressure|Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.|Baseline, 12 weeks, 24 weeks||||mm Hg||Standard Deviation|Mean
1308719|NCT02637063|Primary|Systolic Blood Pressure|Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.|Baseline, 12 weeks, 24 weeks||||mm Hg||Standard Deviation|Mean
1344753|NCT01877408|Secondary|Number of Participants With Complete Wound Healing by Post-Surgery Week 4||Within 4 weeks after surgery||||participants|||Number
1308720|NCT02637037|Secondary|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration [Vz/F]|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||L||Standard Deviation|Mean
1308721|NCT02637037|Secondary|Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC [CL/F]|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||L/h||Standard Deviation|Mean
1308722|NCT02637037|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve [t½λz]|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||Hour (h)||Standard Deviation|Mean
1308723|NCT02637037|Secondary|Time to Reach Maximum Plasma Concentration (t Max)|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||Hour||Full Range|Median
1308724|NCT02637037|Primary|Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State|To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308725|NCT02637037|Primary|AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State.|To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308726|NCT02637037|Primary|Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State|To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308727|NCT02636907|Secondary|Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment|The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase. In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive. The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included). Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.|up to Week 60|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
1308735|NCT02636595|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1308736|NCT02635984|Secondary|Percent of Patients With Complete Response in Delayed Phase|Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy)|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1312747|NCT02499575|Primary|Total Opioid Use as Measured by Questionnaire|Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.|Daily through the third day (72 hours) post-surgery||||morphine equivalents|||Number
1308728|NCT02636907|Secondary|Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions|The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase. In Extension phase, patients were given diaries to record events between each site visit during extension phase. Patients were instructed to accurately record the following on the diary cards: the dates & times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions. Patients were instructed to contact the site if they experienced any AEs between designated site visits. In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set|up to Week 60|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
1308729|NCT02636907|Secondary|Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment|A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication. Data is reported for the autoinjector assessment period. TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.|Up to 17 weeks.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
1308730|NCT02636907|Secondary|Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions|"Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.~Percentage of subjects calculated relative to the total number of subjects in the analysis set."|Up to 17 weeks.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
1308731|NCT02636907|Secondary|Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events|"The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c).~Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful)."|Up to Day 50.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of injections|||Number
1308732|NCT02636907|Primary|Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections|"The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis.~Percentage of injections calculated relative to the total number of first injections."|Up to Day 50.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of injections||95% Confidence Interval|Number
1308733|NCT02636595|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1308734|NCT02636595|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1308737|NCT02635984|Secondary|Percent of Patients With Complete Response in Acute Phase|Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy)|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1308738|NCT02635984|Secondary|Percent of Patients With no Nausea in Overall Assessment Period|No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after)|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1308739|NCT02635984|Secondary|Percent of Participants With no Significant Nausea in Delayed Phase|Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1308740|NCT02635984|Secondary|Percent of Participants With no Significant Nausea in Acute Phase|Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1308741|NCT02635984|Secondary|Percent of Patients Achieving Complete Protection in Overall Assessment Phase|(CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after]|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1308742|NCT02635984|Secondary|Percent of Patients With no Significant Nausea in Overall Assessment Period|Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1308743|NCT02635984|Primary|Overall Percentage of Patients Who Had a Complete Response|Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (< 25 mm on a 100 mm visual analog scale [VAS]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
1308744|NCT02635880|Secondary|Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject|Degree of improvement in treated lesions at 6 weeks post-final treatment as assessed by the subject through a customized subject satisfaction survey. Survey was based upon a scoring 0 - Extremely Unsatisfied, 1 - Unsatisfied, 2 - Neutral, 3- Satisfied, 4 - Extremely Satisfied.|6 weeks post-final treatment||||% of participants|||Number
1308745|NCT02635880|Primary|Percentage of Participants With Change of Treated Lesions|Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement.|Baseline and 6 weeks post-final treatment||||% of participants|||Number
1308746|NCT02635828|Secondary|Incidence of Subjects Significant QTc Changes in the EKG|The incidence of significant QTc prolongation was measured by comparing baseline EKG, 24 hours and 120 hours after surgery|24 and 120 hours/discharge after end of surgery||||participants|||Number
1308747|NCT02635828|Primary|PONV Incidence|The incidence of PONV|24 hours after end of surgery|Incidence of PONV|||participants|||Number
1308748|NCT02635646|Secondary|2h OGTT Glucose|Measurement of 2h post OGTT glucose|6 and 12 months||||mg/dl||Standard Deviation|Mean
1308749|NCT02635646|Secondary|Fasting Glucose|Fasting plasma glucose (mg/dl), normal values are between 70-100 mg/dl.|6 and 12 months||||mg/dl||Standard Deviation|Mean
1308750|NCT02635646|Secondary|Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)|"Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance or similar."|12 months|Matsuda Index measured in the relatives of the patients|||Matsuda Index||Standard Deviation|Mean
1308751|NCT02635646|Primary|Individual Insulin Resistance and Insulin Secretion|"Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance or similar."|12 months||||Matsuda Index||Standard Deviation|Mean
1308752|NCT02635646|Primary|Individual Insulin Resistance and Insulin Secretion|"Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance or similar."|6 months||||Matsuda Index||Standard Deviation|Mean
1308753|NCT02635542|Secondary|Surgical Conditions|Assessed by surgeon questionnaire designed for study to determine any negative effects impeding the progress of surgery or safety, on scale of 1=poor to 5=excellent|During general anesthesia|2 participants in the CIS group and 4 participants in the SUX group had missing data for this outcome.|||units on a scale||Standard Deviation|Mean
1308754|NCT02635542|Primary|Number of Participants With Postoperative Pulmonary Complications|Having at least one of the following complications, determined according to pre-specified criteria: extubation delayed >24hrs, reintubation, mechanical respiratory support, pneumonia, aspiration, ARDS (Acute Respiratory Distress Syndrome), or mortality from respiratory arrest.|72 hours following surgical procedure||||Participants|||Count of Participants
1308755|NCT02635425|Primary|Number of Participants of Severe Ovarian Hyperstimulation Syndrome||2 weeks||||participants|||Number
1308756|NCT02635204|Secondary|Percent of Subjects With Treatment Success at Day 8 Visit|Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|Baseline and Day 8|Intention to treat population defined as all subjects who were randomized and dispensed medication|||percentage of subject|||Number
1308757|NCT02635204|Secondary|Percent Change From Baseline in Body Surface Area at Day 15|Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|Baseline and Day 15|Intention to treat|||percentage change in body surface area||Standard Deviation|Mean
1308758|NCT02635204|Primary|Percentage of Subjects With Treatment Success at Day 15|The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|Day 15 Visit|Intention to treat population defined as all subjects who were randomized and dispensed medication|||percentage of participants|||Number
1308759|NCT02634801|Secondary|Mean Adherence on Medication and Satisfaction With Therapy (STAQ)|"Systemic Therapy Adherence Questionnaire (STAQ) is a 38 item questionnaire that was developed by shortening and adapting the Topical Treatment Adherence Questionnaire (TTAQ) for administration to participants under systemic therapy. The following STAQ items are of special interest for this study.~STAQ item 13 (The treatment does not affect my sex life)~STAQ item 16 (I am enjoying life again as a result of the treatment)~STAQ item 20 (The side effects of the treatment were acceptable)~STAQ item 31 (I am satisfied with the efficacy of the treatment)~STAQ item 32 (I am satisfied with the tolerability of the treatment)~STAQ item 35 (The positive aspects of the treatment outweigh the negative ones).~The STAQ items are on a 4-point Likert scale with scores between 0 (strong disagreement) and 3 (strong agreement). LS mean was calculated using ANCOVA with term for treatment."|Week 24|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Systemic Therapy Adherence Questionnaire (STAQ).|||units on a scale||95% Confidence Interval|Least Squares Mean
1308760|NCT02634801|Secondary|Percentage of Participants Positive Responses to Genital Psoriasis Question|"Studying psoriasis involvement in the face, neck, and the genitals is of considerable interest for participants. These are locations that bear high potential for stigmatization and/or psychological distress, and, hence, effects in those regions are assumed to heavily influence participant's quality of life.~Following set of binary questions were asked to check the satisfaction of participants.~Does the patient currently have visible psoriasis on face/neck? (Yes/No)~Does the patient currently have psoriasis on the genital area? (Yes/No) The genital area includes the labia majora (hair-bearing), labia minora modified mucus membrane, and perineum in female patients; and the penis glans, penis – shaft, and scrotum in male patients."|Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for binary questions.~Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis."|||Percentage of participants|||Number
1308761|NCT02634801|Secondary|Percentage of Participants With Positive Responses to Neck/Face Psoriasis Question|"Studying psoriasis involvement in the face, neck, and the genitals is of considerable interest for participants. These are locations that bear high potential for stigmatization and/or psychological distress, and, hence, effects in those regions are assumed to heavily influence participant's quality of life.~Following set of binary questions were asked to check the satisfaction of participants.~Does the participant currently have visible psoriasis on face/neck? (Yes/No)~Does the participant currently have psoriasis on the genital area? (Yes/No)"|Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for binary questions.~Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis."|||Percentage of Participants|||Number
1308762|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Overall Work Impairment Score|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308763|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Impairment in Activities Performed Outside of Work|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1312748|NCT02499575|Primary|Opioid Use as Measured by Questionnaire|Compare time to first opioid use over 72 hours between groups|Daily through the third day (72 hours) post-surgery||||hours|||Number
1308764|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Presenteeism Score|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO Presenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308765|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Absenteeism Score|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308766|NCT02634801|Secondary|"Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) Bolt On - Visual Analog Scale Score"|"The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L + Bolt on VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||Millimeter (mm)||95% Confidence Interval|Least Squares Mean
1308767|NCT02634801|Secondary|"Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) Bolt On - Psoriasis (PSO) Index Score"|"The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L Bolt On PSO-Index.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308768|NCT02634801|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D) + Bolt On UK Population-based Index Score|"The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a United Kingdom (UK) Population value set to each of the levels in each dimension. This produced participant-level index scores between -0.594 and 1.0 (worse to better health).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L Index.mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1308769|NCT02634801|Secondary|Change From Baseline on the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA-CLIN) Total Score|"NAPPA is a clinical and participant-reported outcomes tool, and consists of 3 components: a questionnaire assessing nail-specific quality of life NAPPA-QoL (Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life), a 2-part questionnaire assessing participant relevant needs and treatment benefits NAPPA-PBI (Nail Assessment in Psoriasis and Psoriatic Arthritis – Patient Benefit Index), and a clinical assessment of objective finger nail psoriasis severity NAPPA-CLIN.~Sum of all assessed finger and toes ranging between 0 (no involvement) to 16 (worst involvement).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who had palmoplantar, scalp, or nail involvement at baseline.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1314907|NCT02434497|Secondary|Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg||Up to 22 months||||ng/mL|||Number
1308770|NCT02634801|Secondary|Change From Baseline on the Psoriasis Skin Appearance Bothersomeness (PSAB) Total Score|"PSAB measure is a 3-item scale designed to measure the degree of bothersomeness of skin appearance due to Ps in participants with Ps. Participants are asked to indicate on 3 numeric rating scales (NRS) from 0 (not at all bothered) to 10 (extremely bothered) how bothered they are by any redness or discoloration, thickness, and scaling or flaking on their skin due to Ps.~The scores from the 3 NRS items are summed for a total score ranging from 0 to 30, where 0 indicating no bothersomeness and 30 indicating greater bothersomeness.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PSAB.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308771|NCT02634801|Secondary|Change From Baseline on Patient’s Global Assessment (PatGA) of Disease Severity|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PatGA.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308772|NCT02634801|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Scores|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, lower scores = more disability, higher scores = less disability and better health. In this study, the SF-36 acute version was used, which has a 1-week recall period.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for SF36 MCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308773|NCT02634801|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS)|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, lower scores = more disability, higher scores = less disability and better health. In this study, the SF-36 acute version was used, which has a 1-week recall period.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for SF36 PCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308774|NCT02634801|Secondary|Change From Baseline on Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16)|"QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for QIDS-SR16.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308775|NCT02634801|Secondary|Change From Baseline on the Skin Pain Visual Analog Scale (VAS)|"The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for skin pain VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||Millimeter (mm)||95% Confidence Interval|Least Squares Mean
1308776|NCT02634801|Secondary|Change From Baseline on Itch Numeric Rating Scale (NRS) Score|"The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for Itch NRS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308777|NCT02634801|Secondary|Patient Benefit Index (PBI) Overall Benefit Score|"The PBI assessment consists of 2 steps: before treatment, every patient defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the patient rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for “did not apply to me” (5) and missing.~For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score.~LS mean was calculated using ANCOVA with LOCF and with a term for treatment."|Week 24|All randomized participants who received at least 1 dose of study drug and had a baseline PBI questionnaire such that postbaseline PBI assessments can be valid (nonmissing).|||units on a scale||95% Confidence Interval|Least Squares Mean
1308778|NCT02634801|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score|"The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).~LS mean change from baseline in PSSI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for Psoriasis Scalp.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308779|NCT02634801|Secondary|Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score|"The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.~LS mean change from baseline in PPASI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PPASI.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308780|NCT02634801|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|"The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.~LS mean change from baseline in BSA was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for BSA.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||% Body Surface Affected||95% Confidence Interval|Least Squares Mean
1308781|NCT02634801|Secondary|Change From Baseline on Dermatology Life Quality Index (DLQI) Total Score|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant. LS mean change from baseline in DLQI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for DLQI.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308782|NCT02634801|Secondary|Percentage of Participants Achieving DLQI (0,1)|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant."|Week 24|All randomized participants who had a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
1308783|NCT02634801|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) and ≥2 Point Improvement From Baseline Among Those With sPGA Score ≥3 at Baseline|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 24|All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
1308794|NCT02634788|Secondary|Time to Peak Pain Relief|Time to peak pain relief is the time to the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). If no pain relief was observed, then the time was censored at the time of the last pain assessment.|From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes)|All randomized participants from the ITT Population|||minutes||95% Confidence Interval|Median
1319429|NCT02316366|Secondary|Global Comfort|Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay|4 hours|||||||
1308784|NCT02634801|Secondary|Change From Baseline in PASI Total Score|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). LS mean change from baseline in PASI was calculated using Analysis of Covariance (ANCOVA) with modified Baseline- Observation- Carried Forward (mBOCF) and with terms for baseline and treatment.|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PASI.~mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1308785|NCT02634801|Secondary|Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 24|All randomized participants who had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
1308786|NCT02634801|Secondary|Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 24|All randomized participants who had a post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
1308787|NCT02634801|Primary|Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 24|All randomized participants who had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
1308788|NCT02634788|Secondary|Participant's Global Evaluation of Study Drug|Global evaluation of study drug was completed at the end of treatment (Day 3) or before early termination if a participant discontinued early. Participants were asked to provide an overall rating of their study medication in controlling pain on a 5-point NRS, where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. The percentage of participants with scores in each pain relief category are reported.|End of treatment (Day 3) or early termination|All randomized participants from the ITT Population.|||percentage of participants|||Number
1308789|NCT02634788|Secondary|Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours|Total use of rescue medication is defined as the number of times a participant took rescue medication.|Over 24 and 48 hours after Time 0 (first dose of study drug)|All randomized participants from the ITT Population who used rescue medication during the specified time intervals.|||number of uses||Standard Deviation|Mean
1308790|NCT02634788|Secondary|Time to First Use of Rescue Medication for Pain|Time to first use of rescue medication is the time from Time 0 (time of administration of the first dose of study drug) to the first use of rescue medication. If rescue medication was not taken the time was censored at the time of the last pain assessment.|From Time 0 to time of first use of rescue medication (up to 280 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
1308791|NCT02634788|Secondary|Percentage of Participants Using Rescue Medication for Pain|The percentage of participants who needed to take an alternate medication for pain relief during the treatment period.|From Time 0 (first dose of study drug) up to 48 hours|All randomized participants from the ITT Population.|||percentage of participants|||Number
1308792|NCT02634788|Secondary|Time to Meaningful Pain Relief|Time to meaningful pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the second stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.|From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
1308793|NCT02634788|Secondary|Time to First Perceptible Pain Relief|Time to first perceptible pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the first stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.|From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
1308795|NCT02634788|Secondary|Percentage of Participants With Peak Scores in Each Pain Relief Category|Peak pain relief is the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with peak scores in each pain relief category are reported.|From Time 0 (first dose of study drug) up to 48 hours|All randomized participants from the ITT Population|||percentage of participants|||Number
1308796|NCT02634788|Secondary|Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0|Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with scores in each pain relief category are reported. Missing values were imputed.|4, 8, 24 and 48 hours after Time 0 (first dose of study drug)|All randomized participants from the ITT Population|||percentage of participants|||Number
1308797|NCT02634788|Secondary|Time to Onset of Analgesia|Time to onset of analgesia was measured as time to first perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method. The study staff started 2 stopwatches as soon as the first dose of study drug was administered. Each participant was instructed to stop the first stopwatch when he or she experienced any perceptible pain relief and the second stopwatch when he or she experienced pain relief that was meaningful to them. If the second stopwatch was not stopped, time was censored at the time of the second dose of study drug or the use of rescue medication, whichever came first. If both stopwatches were not stopped time was censored at the time of the second dose of study drug or the use of rescue medication whichever came first. Time to onset of analgesia was defined as the time when the first stopwatch was stopped given that the second stopwatch is stopped.|From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
1308798|NCT02634788|Secondary|Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0|TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Error|Least Squares Mean
1308799|NCT02634788|Secondary|NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [max=10 at each time point] and negative numbers indicate an increase in pain [min=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population who did not have missing SPID values.|||units on a scale||Standard Deviation|Least Squares Mean
1308800|NCT02634788|Secondary|NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
1308801|NCT02634788|Secondary|NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline – pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.|Baseline and 4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
1308802|NCT02634788|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population who did not have missing SPID-48 values. Missing SPID-48 data were not imputed.|||units on a scale||Standard Error|Least Squares Mean
1322036|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Hematocrit (%)||within 5 minutes upon completion of procedure||||% of red blood cells||Standard Deviation|Mean
1308806|NCT02634580|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308807|NCT02634580|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308808|NCT02634580|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308809|NCT02634580|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308810|NCT02634580|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308811|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308812|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308813|NCT02634580|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308814|NCT02634580|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308815|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308816|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308817|NCT02634580|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308818|NCT02634580|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308819|NCT02634580|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308820|NCT02634580|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308821|NCT02634580|Secondary|Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12||Week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percentage of participants||95% Confidence Interval|Number
1308822|NCT02634580|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL|Mean low density lipoprotein-cholesterol response was defined as LDL-C < 70 mg/dL [1.8 mol/L].|Weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percentage of participants||95% Confidence Interval|Number
1308823|NCT02634580|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||mg/dL||Standard Error|Least Squares Mean
1308824|NCT02634580|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||mg/dL||Standard Error|Least Squares Mean
1308825|NCT02634580|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308826|NCT02634580|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12|For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis.|Baseline and Weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
1308827|NCT02634346|Secondary|Incidence of Adverse Events||Approximately 4 weeks|Number of subjects who received study drug and had a treatment-emergent adverse event|||Participants|||Count of Participants
1308840|NCT02634073|Secondary|Number of Participants With Treatment Emergent Laboratory Abnormality Grade|Division of Acquired immune deficiency syndrome (DAIDS) Table AE grades 1, 2, 3, and 4 of laboratory abnormalities were applied and grade were summarized by treatment and day and were listed by participant, treatment, day, and actual date and time. Treatment emergent grades are defined as any new toxicity grades or the worsened grades compared to Baseline grade. Treatment emergent lab abnormality Grade 1 for aspartate aminotransferase and sodium at follow-up visit are summarized.|Up to Week 5|Safety Population|||Participants|||Number
1308828|NCT02634346|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4."|4 weeks|Subjects who received at least 1 dose of study drug and had at least 1 post-baseline PANSS assessment.|||units on a scale||Standard Error|Least Squares Mean
1308829|NCT02634346|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.|4 weeks|Subjects that received at least 1 dose of study drug and had at least 1 post-baseline PANSS assessment.|||units on a scale||Standard Error|Least Squares Mean
1308830|NCT02634073|Secondary|Change From Baseline in Albumin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for albumin was calculated as the post-dose Visit Value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||G//L||Standard Deviation|Mean
1308831|NCT02634073|Secondary|Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for creatinine and direct bilirubin were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Change from Baseline in total bilirubine was not assessed. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||micromole (umol)/L||Standard Deviation|Mean
1308832|NCT02634073|Secondary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for AST, ALT and alkaline phosphatase were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Unit (U)/L||Standard Deviation|Mean
1308833|NCT02634073|Secondary|Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for BUN, sodium, potassium, glucose, calcium were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||millimole (mmol)/L||Standard Deviation|Mean
1308834|NCT02634073|Secondary|Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||10^9 cells/L||Standard Deviation|Mean
1308835|NCT02634073|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV)|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCV was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Femtoliter||Standard Deviation|Mean
1308836|NCT02634073|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH)|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCH was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Picogram||Standard Deviation|Mean
1308837|NCT02634073|Secondary|Change From Baseline in Hemoglobin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hemoglobin was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||G/L||Standard Deviation|Mean
1308838|NCT02634073|Secondary|Change From Baseline in Hematocrit|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hematocrit was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Fraction of 1||Standard Deviation|Mean
1308839|NCT02634073|Secondary|Change From Baseline in Erythrocytes|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for erythrocytes was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||10^12 cells/L||Standard Deviation|Mean
1308841|NCT02634073|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from Baseline for DBP and SBP was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1308842|NCT02634073|Secondary|Change From Baseline in Body Temperature|Change from Baseline for body temperature was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population|||Degree centigrade||Standard Deviation|Mean
1308843|NCT02634073|Secondary|Change From Baseline in Pulse Rate|Change from Baseline for pulse rate was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Beats/min||Standard Deviation|Mean
1308844|NCT02634073|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE)|An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|Up to 5 Weeks|Safety Population: defined as all participants who enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1308845|NCT02634073|Primary|Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period.|Day 1 to Day 3 in each treatment period||||Hr||Full Range|Median
1308846|NCT02634073|Primary|Plasma Lamivudine Apparent Oral Clearance (CL/F)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine CL/F|Day 1 to Day 3 in each treatment period|PK Summary Population|||Liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
1308847|NCT02634073|Primary|Lamivudine Elimination Half-life in Plasma (t1/2)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine t1/2.|Day 1 to Day 3 in each treatment period|PK Summary Population|||Hour (Hr)||Geometric Coefficient of Variation|Geometric Mean
1308848|NCT02634073|Primary|Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. Time of the last measurable concentration (t) was 48 hours for all participants and all treatments. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine PK parameters.|Day 1 to Day 3 in each treatment period||||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1308849|NCT02634073|Primary|Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters.|Day 1 to Day 3 in each treatment period|PK Summary Population: defined as participants who had valid lamivudine PK parameter estimates from both reference and test treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||hour (h)*microgram (mcg)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1308850|NCT02633956|Primary|The Effect of Obeticholic Acid on LDL Particle Concentration (Total) (Least Squares Mean Change From Baseline at Week 16)|The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic NASH and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL particle concentration (total)|Baseline and Week 16|Efficacy evaluable population|||nmol/L||Standard Error|Least Squares Mean
1308851|NCT02633956|Primary|The Effect of Obeticholic Acid on LDL Particle Size (Least Squares Mean Change From Baseline at Week 16)|The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed NASH and the ability of atorvastatin to modulate this effect as measured by change from baseline (least squares mean) at week 16 in LDL particle size. It is LDL particle diameter size (nm) that is reported.|Baseline and Week 16|Efficacy evaluable population|||nm||Standard Error|Least Squares Mean
1308852|NCT02633956|Primary|The Effect of Obeticholic Acid on Low-density Lipoprotein (LDL) Concentration (Least Squares Mean Change From Baseline at Week 16)|The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic steatohepatitis (NASH) and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL concentration|Baseline and Week 16|Efficacy evaluable population|||mg/dL||Standard Error|Least Squares Mean
1308866|NCT02632812|Primary|Prostaglandin Level (PGE2 Quantification)|Tissue prostaglandin concentration quantified by enzyme-linked immunosorbent assay (ELISA) using Cayman Chemical Monoclonal Prostaglandin E2 EIA Kit (item number 514010)|8 days||||pg/mL (mean tissue PGE2 concentration)||95% Confidence Interval|Mean
1308853|NCT02633787|Primary|Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster, 28 Days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1308854|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1308855|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days, and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1308856|NCT02633371|Primary|Number of Patients With Improvement in Hyperhidrosis Severity at Week 1 or Week 4 as Measured by the Hyperhidrosis Disease Severity Scale (HDSS).|A treatment responder is defined as any participant with a change in the Hyperhidrosis Disease Severity Scale (HDSS) score from a baseline score of 3 or 4 to a score of 1 or 2 at week 1 or week 4.|Week 1 and week 4||||participants|||Number
1308857|NCT02633215|Secondary|Change in Wolf Motor Function Test (WMFT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.|baseline, post-intervention, 1-month follow-up||||log(seconds)||Standard Error|Mean
1308858|NCT02633215|Secondary|Change in Action Arm Research Test (ARAT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance.|baseline, post-intervention, 1-month follow-up||||units on a scale||Standard Error|Mean
1308859|NCT02633215|Primary|Change in Fugl Meyer Assessment Motor Score|Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.|baseline, post-intervention, 1-month follow-up||||units on a scale||Standard Error|Mean
1308860|NCT02632838|Other Pre-specified|Hospital Admissions for Hypertension Related Illnesses|Data obtained from patients' electronic health records. Total number of hospital admissions for hypertension related illnesses were compared at baseline and 6 months.|6 months|All study sample were analyzed|||hospital admissions|||Number
1308861|NCT02632838|Other Pre-specified|Patient Self-efficacy|Medication Adherence Self-Efficacy Scale (MASES) were used to measure the patient self-efficacy in adhering to prescribed hypertension medications. MASES was developed to measure several aspects of self-efficacy, including adherence to prescribed medication for the management of hypertension. The MASES includes 26 items rated on a 3-point Likert scale (1= Not at all Sure, 2= Somewhat Sure, and 3= Very Sure). The range of this scale is from 26 to 78. A total mean score is calculated by averaging responses to all items. Higher scores indicate a great level of self-efficacy The survey scores compared at baseline and 6 months.|baseline and 6-month|All study sample were analyzed.|||units on a scale||Standard Deviation|Mean
1308862|NCT02632838|Other Pre-specified|Health-Related Quality of Life|"Health-Related Quality of Life were measured by 36-Item Short Form Health Survey (SF-36).~The SF-36 consisted of the sum scores of eight subscales (physical functioning, physical role limitations, mental health, emotional role limitations, social functioning, vitality, pain, and general health perceptions), which are the weighted sums of the questions in each sections. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight subscales were summarized into two composite scores (physical and mental quality of life). Various studies demonstrated that the reliability of the SF-36 have exceeded 0.80 The SF-36 scores compared at baseline and 6-month later"|baseline and 6-month|All study sample data were analyzed.|||units on a scale||Standard Deviation|Mean
1308863|NCT02632838|Secondary|Blood Pressure Monitoring Adherence|"BP monitoring adherence were used to measure hypertension status monitoring experiences BP monitoring adherence for the mHealth group was calculated by dividing the total number of times iHealth BP-7 was used to measure BP by the total number of expected times it should have been used (one BP measurement performed every day for 6 months).~BP monitoring adherence for the standard follow-up group was calculated by dividing the total number of office visits to measure BP by the total number of expected visits (one office BP measurement every week for 6 months)."|6 months|All study sample were analyzed.|||adherence|||Number
1308864|NCT02632838|Primary|Blood Pressure (BP) Change|"BP change defined as monthly average BP in both systolic and diastolic blood pressure decrease. BP decline were expected as early as 3 month of intervention and kept to decreasing over 6 month period.~For the mHealth group: iHealth’s MyVitals BP data were collected by a project research assistant every week. Data were aggregated, and an average of the BP readings recorded at baseline, 3-month and 6-month were used for data analysis.~For the standard follow up group, participants’ BP was measured in an upright seated position with feet flat on the floor while being at rest for at least 5 minutes. During each week's office visit, participants were measured twice or more, separated by two minutes in each arm. The Welch Allyn Spot Vital Signs LXi electronic blood pressure monitor was utilized for this group. Data were aggregated, and an average of the BP readings recorded at baseline, 3-month and 6-month were used for data analysis."|baseline, 3 monthly intervals over 6 months of follow up|All study sample were analyzed.|||mm Hg||Standard Deviation|Mean
1308865|NCT02632812|Secondary|Number of Adverse Events||60 days||||adverse events|||Number
1308867|NCT02632812|Primary|Presence of H. Pylori by Biopsy|Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori)|8 days||||participants|||Number
1308869|NCT02632812|Primary|Histopathological Score|"Histopathologic grade score developed for microscopic injury evaluation 0 = Normal gastric mucosa or mild chronic inflammation~= Chronic gastritis without activity~= Chronic gastritis with activity on antrum~= Chronic gastritis with activity on the body~= Chronic gastritis with activity on antrum and on the body"|8 days||||Histopathologic grade score||Full Range|Median
1308870|NCT02632812|Primary|Endoscopic Score - Modified Lanza Score|"Modified Lanza score according to gastroduodenal mucosal injury:~0 = No hemorrhage or erosion observed~= One or two hemorrhages or erosions observed in one gastric area~= Three to five hemorrhages or erosions observed in one gastric area~= Hemorrhages or erosions observed in two gastric areas, six or more hemorrhages or erosions observed in one gastric area, with the total number not exceeding ten in the entire stomach~= Hemorrhages or erosions observed in three or more gastric areas; eleven or more hemorrhages or erosions observed widely in the entire stomach~= Ulcer"|8 days||||Modified Lanza score||Full Range|Median
1308871|NCT02632812|Primary|Endoscopic Score - Cryer Score|"Cryer score according to gastroduodenal mucosal injury:~0 = Normal or erythema~= Any amount of submucosal hemorrhage or edema without erosions~= 1 erosion +- submucosal hemorrhage or edema~= 2-4 erosions +- submucosal hemorrhage or edema~= 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema~= Multiple ulcers +- submucosal hemorrhage or edema - Ulcer"|8 days|All recruited volunteers completed the trial.|||Cryer score||Full Range|Median
1308872|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308873|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308874|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308875|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308876|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||AK Fields|AK Fields||Count of Units
1308877|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308878|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308879|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308880|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308881|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||AK Fields|AK Fields||Count of Units
1308882|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308883|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308884|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308885|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 Hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308886|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1||||AK Fields|AK Fields||Count of Units
1308887|NCT02632110|Other Pre-specified|Stinging/Burning|"﻿Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.~STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable"|During PDT #1||||AK Fields|AK Fields||Count of Units
1308888|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||AK Fields|AK Fields||Count of Units
1308889|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308890|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308912|NCT02632110|Secondary|Percent Change|Percent change in the total AK number as compared with Baseline|Baseline and Week 8|split face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.|||percent change|AK Fields|Standard Deviation|Mean
1308891|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308892|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308893|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1||||AK Fields|AK Fields||Count of Units
1308894|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||AK Fields|AK Fields||Count of Units
1308895|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308896|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308897|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308898|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308899|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1||||AK Fields|AK Fields||Count of Units
1308900|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|split face|||AK Fields|AK Fields||Count of Units
1308913|NCT02632110|Secondary|Baseline AKCR|AK clearance rate for only those lesions present at Baseline|Baseline and Week 12|split-face|||percentage cleared|AK Fields|Standard Deviation|Mean
1309572|NCT02605187|Secondary|Count of Participants With Presence of Pruritus|Count of participants with pruritus through 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
1308901|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308902|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308903|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308904|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308905|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||AK Fields|AK Fields||Count of Units
1308906|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308907|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308908|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308909|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308910|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|split-face|||AK Fields|AK Fields||Count of Units
1308914|NCT02632110|Secondary|Baseline AKCR|AK clearance rate (AKCR) for only those lesions present at Baseline|Baseline and Week 8|split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.|||percentage cleared|AK Fields|Standard Deviation|Mean
1308915|NCT02632110|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|split-face.|||AK Fields|AK Fields||Count of Units
1308916|NCT02632110|Secondary|Complete Clearance Rate|Number of AK Fields with 0 Lesions|Week 8|split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
1308917|NCT02632110|Primary|Complete Clearance Rate|Number of AK Fields with 0 lesions|Week 12|Split-face study|||AK Fields|AK Fields||Count of Units
1308918|NCT02631551|Primary|Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.|Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate).|14 days|The Full Analysis Set (FAS) was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.|||units on a scale||Standard Deviation|Mean
1308919|NCT02631057|Primary|Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline|The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.|From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.|The analysis set included patients who received the treatment Dabigatran Etexilate [Prazaxa®] or Warfarin.|||Months||Standard Deviation|Mean
1308920|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Plasma concentration of clavulanate 1.425 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
1308921|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Plasma concentration of clavulanate 1.6 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
1308922|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2|"Participants treated with formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Plasma concentration of amoxicillin 40 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||micrograms per milliliter (mcg/ml)||Standard Deviation|Mean
1308923|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Plasma concentration of amoxicillin 45 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||micrograms per milliliter (mcg/ml)||Standard Deviation|Mean
1308924|NCT02630992|Secondary|The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively."|The end-of-treatment visit. The mean day for this visit was 13.9.|The number of participants is equal to the number of children receiving formulation 2 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit.|||units on a scale||Standard Deviation|Mean
1308925|NCT02630992|Secondary|The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively."|The end-of-treatment visit. The mean day for this visit was 14.9.|The number of participants is equal to the number of children receiving formulation 1 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit.|||units on a scale||Standard Deviation|Mean
1308926|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 2 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~An assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.~The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms."|Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6.|The number of participants is equal to the number of children receiving formulation 2 who had a day 7 assessment.|||Participants|||Count of Participants
1308927|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 1 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~An assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.~The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms."|Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5.|The number of participants is equal to the number of children receiving formulation 1 who had a day 7 assessment.|||Participants|||Count of Participants
1308928|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Treatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9.|The number of participants is equal to the number of children receiving formulation 2 who had an end-of-treatment assessment at or before the day 12 visit.|||Participants|||Count of Participants
1308929|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Treatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9.|The number of participants is equal to the number of children receiving formulation 1 who had an end-of-treatment assessment at or before the day 12 visit.|||Participants|||Count of Participants
1308930|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 2.|||Participants|||Count of Participants
1308931|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 1.|||Participants|||Count of Participants
1308932|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 2.|||Participants|||Count of Participants
1308933|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 1.|||Participants|||Count of Participants
1308934|NCT02630563|Secondary|Plasma Concentration of Mycophenolic Acid and Its Metabolite Mycophenolic Acid Glucuronide at Each Time Point|Mycophenolic Acid Glucuronide (MPAG) is an active metabolite of Mycophenolic Acid (MPA).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol.|||mcg/mL||Standard Deviation|Mean
1308935|NCT02630563|Primary|Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours of Mycophenolic Acid Normalized for Dose And for Body Surface Area|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC0-12h was normalized to 600 milligram per square meter (mg/m^2) and 1.5 gram. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The pharmacokinetic (PK) population included all randomized and replaced participants adherent to the PK section of the protocol.|||mcg*h/mL||Standard Deviation|Mean
1308936|NCT02630563|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Day 32|The safety population included all participants who were enrolled in the trial|||participants|||Number
1308937|NCT02630563|Secondary|Time to Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|Tmax is the amount of time after dosing to when the maximum concentration of MPA and MPAG was achieved.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.|||hour||Full Range|Median
1308938|NCT02630563|Secondary|Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was obtained directly from the measured plasma concentration-time curves.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.|||mcg/mL||Standard Deviation|Mean
1308939|NCT02630563|Secondary|Area Under the Plasma Concentration Time Curve From 0-12 Hours for Mycophenolic Acid and Mycophenolic Acid Glucuronide Phenolic Glucuronide of Mycophenolic Acid|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol|||mcg*h/mL||Standard Deviation|Mean
1308940|NCT02629354|Secondary|AUC0-INF of Ibuprofen|This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308941|NCT02629354|Secondary|AUC0-INF of R-ibuprofen|This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308942|NCT02629354|Primary|AUC0-t of Ibuprofen|This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308943|NCT02629354|Primary|AUC0-t of R-ibuprofen|This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308944|NCT02629354|Secondary|Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF)|This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308945|NCT02629354|Primary|Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t)|This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||hour (h)*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308946|NCT02629354|Primary|Cmax of Ibuprofen|This outcome measure presents the Cmax of ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308947|NCT02629354|Primary|Cmax of R-ibuprofen|This outcome measure presents the Cmax of R-ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308948|NCT02629354|Primary|Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen|This outcome measure presents the maximum observed concentration (Cmax) of S-ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|Pharmacokinetic (PK) population: all subjects who completed the PK sampling in both periods and with no major protocol deviations considered to impact on the analysis of the PK data were included.|||nanogram (ng)/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1308949|NCT02629094|Primary|Improvement of Hepatic Steatosis: Mean Change in Hepatic Percentage of Lipid by MR Spectroscopy|Mean change in hepatic percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline hepatic percentage value of lipid from the week 24 hepatic percentage value of lipid by MR spectroscopy.|24 weeks|Analyses included participants who completed 24 weeks on study drug eplerenone.|||percentage of lipid||Standard Deviation|Mean
1308950|NCT02629094|Primary|Improvement of Cardiac Steatosis: Mean Change in Intraventricular Septum Percentage of Lipid by MR Spectroscopy.|Mean change in intraventricular septum percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline intraventicular septum percentage value of lipid from the week 24 intraventicular septum percentage value of lipid by MR spectroscopy.|24 weeks|Analyses included participants who completed 24 weeks on study drug eplerenone.|||percentage of lipid||Standard Deviation|Mean
1308951|NCT02628938|Secondary|Self-assessment of Mouth Odor After 7 Days of Use|"Participants were asked to score their own halitosis on a continuous 10-cm visual analogue scale that is marked as no odor on the 0-cm end, and as extremely foul odor on the 10-cm end"|After 7 days of first use||||units on a scale||Standard Deviation|Mean
1308952|NCT02628938|Secondary|Volatile Sulfur Compound Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect)|Scores using breath checker device (Tanita FitScan HC-212SF Breath Checker) were recorded (0=no odor, 1=slight odor, 2=moderate odor, 3=heavy odor, 4=strong odor, 5=intense odor).|After the first use of the prescribed method by 15 minutes, and after 7 days of use||||units on a scale||Standard Deviation|Mean
1308953|NCT02628938|Primary|Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).|"The Organoleptic scores were obtained by a calibrated judge who first tested her ability to detect and distinguish odors even at low concentrations using the Smell Identification Test (Sensonics Inc., Haddon Heights, NJ, USA).~To obtain the score, the patient was asked to close her mouth for approximately 3 minutes while breathing only from the nose. Then he/she was asked to release air from the mouth slowly. The judge kept a distance of about 10 cm between her nose and the patient's mouth to determine the score based on the intensity of the odor.~The intensity ratings of 0 to 5 score was used where Score 0 stands for No odor present, score 1 stands barely noticeable odor, score 2 stands slight but clearly noticeable odor, score 3 stands moderate odor, score 4 stands strong offensive odor and a Score 5 stands extremely foul odor."|After the first use of the prescribed method by 15 minutes, and after 7 days of use||||units on a scale||Standard Deviation|Mean
1308954|NCT02628418|Secondary|The Costs Involved in Using Gloreha in the Rehabilitation|Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.|Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.||||Euros/patient|||Number
1308955|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.|"The Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.~The Quick-DASH is a 19-item ordinal scale with a 5-level rating of items from 1 (no difficulty) to 5 (unable to do).~Quick-Dash can be divided into an 11-item (abilities and symptoms) and an 8-item optional work module and sports/performing arts module. In the 11-item sub-scale, the subject defines the ability to perform some actions (8 items) and the intensity of some symptoms (3 items), referring to the previous week. The total score range is from 19 (no disability) to 95 (full disability)."|Baseline and end of the study after 30 sessions, an average of 6 weeks||||units on a scale||95% Confidence Interval|Mean
1308956|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.|The Pinch test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks||||kg / (kg / m ^ 2||95% Confidence Interval|Mean
1308957|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.|The Grip test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks||||kg / (kg / m ^ 2)||95% Confidence Interval|Mean
1308958|NCT02628418|Secondary|The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)|The feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult). This outcome was measured only in the Gloreha Group in which patients were treated with device.|Baseline and end of the study after 30 sessions, an average of 6 weeks||||units on a scale||Standard Deviation|Mean
1308959|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.|Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.|Baseline and end of the study after 30 sessions, an average of 6 weeks||||pegs/sec||95% Confidence Interval|Mean
1308960|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation|"Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction.~The total upper extremity score involved adding one to the sum of the three actions.~The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100."|Baseline and end of the study after 30 sessions, an average of 6 weeks||||units on a scale||95% Confidence Interval|Mean
1308961|NCT02628418|Primary|Side Effects Using Gloreha Device|The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);|Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.||||side effects|||Number
1308962|NCT02628418|Primary|Number of Patients Who Completed the Hand Rehabilitation Program||Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.||||participants|||Number
1308963|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4||||Participants|||Count of Participants
1308964|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 hours after PDT||||Participants|||Count of Participants
1308965|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||Participants|||Count of Participants
1308966|NCT02628236|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4||||Participants|||Count of Participants
1308967|NCT02628236|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 hours after PDT||||Participants|||Count of Participants
1308968|NCT02628236|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||Participants|||Count of Participants
1308969|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Week 4||||Participants|||Count of Participants
1308970|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 hours after PDT||||Participants|||Count of Participants
1308971|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 Minutes after photodynamic therapy||||Participants|||Count of Participants
1308972|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Intraprocedure||||Participants|||Count of Participants
1308973|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||Participants|||Count of Participants
1308974|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4||||Participants|||Count of Participants
1308975|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 hours after PDT||||Participants|||Count of Participants
1308976|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT||||Participants|||Count of Participants
1308977|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||Participants|||Count of Participants
1308978|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4||||Participants|||Count of Participants
1308979|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 hours after PDT||||Participants|||Count of Participants
1308980|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT||||Participants|||Count of Participants
1308981|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||Participants|||Count of Participants
1308982|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4||||Participants|||Count of Participants
1308983|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24 hours after PDT||||Participants|||Count of Participants
1308984|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||Participants|||Count of Participants
1316286|NCT02397694|Secondary|The Change From Baseline in log10 HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1308985|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4||||Participants|||Count of Participants
1308986|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 hours after PDT||||Participants|||Count of Participants
1308987|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||Participants|||Count of Participants
1308988|NCT02628236|Primary|AUCt/AUCBL for PpIX|The ratio of AUCt to AUCBL for PpIX|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose||||ratio||95% Confidence Interval|Geometric Mean
1308989|NCT02628236|Primary|AUCt for PpIX|The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration.|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1308990|NCT02628236|Primary|AUCBL for PpIX|The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast.|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1308991|NCT02628236|Primary|Time at Which Cmax is Attained (Tmax) for PpIX|Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|2 days|One subject had tmax that could not be determined.|||hours||Full Range|Median
1308992|NCT02628236|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX|Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.|2 days|For 50% of the subjects, more than 50% of the PpIX plasma concentrations following topical application of ALA HCI were less than the predose plasma concentration. Therefore, negative values were set to 0 to evaluate median baseline corrected plasma concentration.|||ng/mL||Full Range|Median
1308993|NCT02628236|Primary|The Terminal Exponential Half-life (T1/2,z) for ALA|The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.|2 days|T1/2,z could not be determined in 11 subjects|||hours||Geometric Coefficient of Variation|Geometric Mean
1308994|NCT02628236|Primary|AUCt|AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1308995|NCT02628236|Primary|Time at Which Cmax is Attained (Tmax) for ALA|Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|2 days||||hours||Full Range|Median
1308996|NCT02628236|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA|Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.|2 days||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1308997|NCT02628106|Primary|the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI|the R2* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue|baseline and after 14days of lipo-PGE1 intravenously|A random sample, west China hospital, in accord with a standard 21 people,age > 18 years|||1/ms||Standard Deviation|Mean
1308998|NCT02627794|Secondary|35 Days Middle Turbinate Position|35 days middle turbinate position|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
1308999|NCT02627794|Secondary|35-day Frequency of Oral Steroid Rescue|35-day frequency of oral steroid rescue|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
1309000|NCT02627794|Secondary|35-day Frequency of Postoperative Interventions|35-day frequency of postoperative interventions, including lyses of adhesions and debridement.|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
1309001|NCT02627794|Secondary|90-day Sinonasal Outcomes Test-22 (SNOT- 22) Scores|90-day Sinonasal Outcomes Test-22 (SNOT- 22) scores|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
1309052|NCT02625207|Secondary|Part 1: Plasma Concentration of Maraviroc at 12 Hours Post-dose||12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309002|NCT02627794|Secondary|35 and 90-day Post ESS Incidence of Middle Meatal Synechiae|35 and 90-day post ESS incidence of middle meatal synechiae|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
1309003|NCT02627794|Secondary|35 and 90-day Intraocular Pressure (IOP) Assessment|35 and 90-day intraocular pressure (IOP) assessed using applanation tonometry and compared to baseline IOP obtained preoperatively|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
1309004|NCT02627794|Secondary|90-day Sinonasal Mucosal Inflammation Assessment|90-day sinonasal mucosal inflammation assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
1309005|NCT02627794|Primary|Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer.|The main objective of the trial is to evaluate basic device usability and confirm safety and effectiveness of Restora™ Mometasone Furoate eluting spacer as compared to a Silastic spacer. 35-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system.|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.||||Participants|||Count of Participants
1309006|NCT02627144|Primary|Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine||Up to 52 weeks|FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically.||||||
1309007|NCT02627144|Primary|Overall Survival (OS) Time|OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS|||months||95% Confidence Interval|Median
1309008|NCT02627144|Primary|Progression-free Survival (PFS) Time|PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS|||months||95% Confidence Interval|Median
1309009|NCT02627144|Primary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|FAS. ‘Number of participants analyzed’ indicate participants who were evaluable for this measure.|||percentage of participants|||Number
1309010|NCT02627144|Primary|Percentage of Participants With Best Overall Tumor Response|Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data.|||percentage of participants|||Number
1309011|NCT02627118|Primary|BPA Level Following 2 Months of Dialysis|blood sampling of BPA (Bisphenol-A) in ng/mL following 2 months of dialysis with the Fresenius 160NR or the Nipro Elisio 15-H|2 MONTHS OF TREATMENT|When data was collected, BPA level was not measureable in one patient (lab reported the presence of unidentified “interfering substance”) and that patient’s data was removed from final analysis.|||ng/mL||Standard Error|Mean
1309012|NCT02627001|Primary|Received Minute Volume (Liters) as Measured by Wright Respirometer|An Impact 731 Ventilator will be attached to a mask. Subjects will hold a mask seal on a cadaver for 100 seconds. The Impact 731 Ventilator will then deliver standardized tidal volumes of 750 cc (delivered tidal volume) 10 times at six second intervals. A Wright respirometer will then measure received tidal volume for each of these 10 breaths.|1 Minute||||Liters||Inter-Quartile Range|Median
1309013|NCT02626910|Primary|Satisfaction With Medical Care Survey|Multinomial logistic regression models will be used to determine the degree to which people with disabilities and without have satisfaction with medical care obtained from the survey. The scale ranges from 1 (not satisfied) to 4 (very satisfied) with their medical care. Higher scores represent more satisfaction with medical care. Unit of measurement is units on a scale.|One year|Satisfaction with healthcare|||units on a scale||Standard Deviation|Mean
1309014|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 5 Allergens (When Applicable) Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 5 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock’s criteria) at week 36, will be reported.|36 weeks|Number of participants analyzed reflects only those participants with 5 or more food allergies|||Participants|||Count of Participants
1309015|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 4 Allergens (When Applicable) Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 4 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock’s criteria) at week 36, will be reported.|36 weeks|Number of participants analyzed reflects only those participants with 4 or more food allergies|||Participants|||Count of Participants
1309016|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 3 Allergens (When Applicable) Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 3 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock’s criteria) at week 36, will be reported.|36 weeks|Number of participants analyzed reflects only those participants with 3 or more food allergies.|||Participants|||Count of Participants
1309017|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to (4,000 mg each of 2 allergens at week 36) (i.e. no reaction of grade 1 or more according to Bock’s criteria) .|36 weeks||||Participants|||Count of Participants
1309018|NCT02626611|Primary|The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance Phase), Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 2 allergens (i.e. no reaction of grade 1 or more according to Bock’s criteria) at week 36, will be reported.|36 weeks||||Participants|||Count of Participants
1309019|NCT02625844|Primary|Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs)|Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs)|Up to 3 months||||hours/year|||Number
1309020|NCT02625402|Secondary|Percentage of Participants With a Clear Treatment Preference|1 item assessing patient's treatment preference (surgery, non-surgical options, or not sure). The percentage who have a clear preference (either for surgery or non surgical options) will be calculated.|In clinic, immediately before the first visit with surgeon||||Participants|||Count of Participants
1309021|NCT02625402|Secondary|Percentage of Participants Who Used the Decision Aid|1 item asking patients how much they reviewed the program (none, some. most, all). The percentage who report viewing most or all will be calculated.|In clinic, immediately before the first visit with surgeon|We wanted to assess how much patients reviewed whichever decision aid they were randomized to before their visit. As such, we assessed how much they reviewed of the program (none, some, most, all) and will share the categorical results.|||Participants|||Count of Participants
1309022|NCT02625402|Primary|Hip and Knee Decision Quality Instruments Knowledge Subscale Scores|5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.|In clinic, immediately before the first visit with surgeon|The total knowledge score of 5 multiple questions with a total score of 0-100% was generated for all study patients.|||units on a scale||Standard Deviation|Mean
1309023|NCT02625298|Secondary|Presence of Clinical Symptoms|Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.|baseline||||participants|||Number
1309024|NCT02625298|Primary|Changes Between Initial and Post Treatment Dimensions of Periapical Lesions|Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.|baseline, 3, 6, 12 and 24 months||||square millimeters|tooth|Standard Deviation|Mean
1309025|NCT02625259|Secondary|Part 1: Renal Clearance (CLr) of TAK-117||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||liter per hour (L/hr)||Standard Deviation|Mean
1309026|NCT02625259|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The PK-evaluable population where data at specified time points were available. The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1309027|NCT02625259|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1309028|NCT02625259|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||hours||Full Range|Median
1309029|NCT02625259|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic (PK)-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1309089|NCT02621047|Secondary|Tmax for Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Full Range|Median
1309030|NCT02625233|Primary|Visual Acuity (logMAR)|The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.|Up to 6 Month Follow-up|Subjects that completed all study visits.|||LogMAR|Subject Eyes|Standard Deviation|Mean
1309031|NCT02625233|Primary|Proportion of Eyes Grade 3 or Higher SLF|Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.|Up to 6 Month Follow-up|Subjects that were dispensed a study lens.|||Proporiton of Subject Eyes|Subject Eyes||Number
1309032|NCT02625220|Primary|Proportion of Subject Eyes With Acceptable Lens Fit|Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.|15 Minute Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
1309033|NCT02625220|Primary|Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees|Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as ‘response=1’ if the lens stability was less than or equal to 5 degrees or ‘response=0’ otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.|15 Minutes Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
1309034|NCT02625220|Primary|The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees|Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as ‘response=1’ if the absolute rotation is less than or equal to 10 degrees or ‘response=0’ otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.|15 Minutes Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
1309035|NCT02625220|Primary|Proportion of Eyes With Monocular Visual Acuity Better Than 20/40|Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.|7 day follow-up|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
1309036|NCT02625207|Secondary|Part 2: Number of Participants With Laboratory Abnormalities|Criteria: Hemoglobin; hematocrit; red blood cell count: <0.8*LLN, mean corpuscular volume; mean corpuscular hemoglobin concentration; mean platelet volume: <0.9*LLN or >1.1*ULN, platelet: <0.5*LLN or >1.75*ULN, white blood cells <0.6*LLN or >1.5*ULN, lymphocyte; neutrophil: <0.8*LLN or >1.2*ULN, basophil; eosinophil; monocyte: >1.2*ULN, bilirubin (total, direct, indirect) >1.5*ULN, aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase: >3.0*ULN, total protein; albumin: <0.8*LLN or >1.2*ULN; creatinine: >1.3*ULN, uric acid >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride; calcium; bicarbonate:<0.9*LLN or >1.1*ULN, glucose <0.6*LLN or >1.5*ULN, urine specific gravity <1.003, urine pH <4.5 or >8, urine glucose or ketones (qualitative) >=1, urine protein; urine blood/hemoglobin >=1, urobilinogen; bilirubin; nitrite; leukocyte esterase >=1.|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
1309037|NCT02625207|Secondary|Part 1: Number of Participants With Laboratory Abnormalities|Criteria: Hemoglobin; hematocrit; red blood cell count: <0.8*lower limit of normal, (LLN), mean corpuscular volume; mean corpuscular hemoglobin concentration; mean platelet volume:<0.9*LLN or >1.1* upper limit of normal (ULN), platelet: <0.5*LLN or >1.75*ULN, white blood cells <0.6*LLN or >1.5*ULN, lymphocyte; neutrophil: <0.8*LLN or >1.2*ULN, basophil; eosinophil; monocyte:>1.2*ULN, bilirubin (total, direct, indirect) >1.5*ULN, aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase:>3.0*ULN, total protein; albumin:<0.8*LLN or >1.2*ULN; creatinine: >1.3*ULN, uric acid>1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride; calcium; bicarbonate:<0.9*LLN or >1.1*ULN, glucose <0.6*LLN or >1.5*ULN, urine specific gravity <1.003, urine pH <4.5 or >8, urine glucose or ketones (qualitative) >=1, urine protein; urine blood/hemoglobin >=1, urobilinogen; bilirubin; nitrite; leukocyte esterase >=1.|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1309038|NCT02625207|Secondary|Part 2: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: Maximum PR interval of >=300 msec, maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent for baseline values of >200 msec and >=50 percent for baseline values of <=200 msec for PR interval, maximum increase from baseline of >=50 percent for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
1309051|NCT02625207|Secondary|Part 2: Plasma Concentration of Maraviroc at 24 Hours Post-dose||24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309039|NCT02625207|Secondary|Part 1: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: Maximum PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent for baseline values of >200 msec and >=50 percent for baseline values of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50 percent for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1309040|NCT02625207|Secondary|Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities included supine/sitting pulse rate of <40 bpm or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine SBP and standing SBP of <90 mm Hg, >=30 mm Hg, supine DBP and standing DBP of <50 mm Hg, >=20 mm Hg.|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
1309041|NCT02625207|Secondary|Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities included supine/sitting pulse rate of less than (<) 40 beats per minute (bpm) or greater than (>)120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine systolic blood pressure (SBP) and standing SBP of <90 millimeter of mercury (mm Hg), greater than or equal to (>=) 30 mm Hg, supine diastolic blood pressure (DBP) and standing DBP of <50 mm Hg, >=20 mm Hg.|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1309042|NCT02625207|Secondary|Part 2: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 11 days that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (up to 11 days)|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
1309043|NCT02625207|Secondary|Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 days that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to end of study (up to 6 days)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1309044|NCT02625207|Secondary|Part 1: Plasma Concentration of Metabolites of Maraviroc at 12 Hour Post-dose|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|12 hour post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309045|NCT02625207|Secondary|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metabolites of Maraviroc|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
1309046|NCT02625207|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of Metabolites of Maraviroc|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309047|NCT02625207|Secondary|Part 1: Average Plasma Concentration (Cav) of Metabolites of Maraviroc|Cavg is the average plasma concentration of metabolites of maraviroc during the 0 to 12 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 12 hours (AUC [0-12]) divided by 12. Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309048|NCT02625207|Secondary|Part 1: Area Under The Plasma Concentration-Time Curve From Time 0 to 12 Hours (AUC [0-12]) of Metabolites of Maraviroc|AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose. Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1309049|NCT02625207|Secondary|Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||hour||Full Range|Median
1309050|NCT02625207|Secondary|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
1309573|NCT02605187|Primary|Count of Participants Who Need Opioid Use|Count of participants who need opioid use through 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
1309053|NCT02625207|Secondary|Part 2: Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309054|NCT02625207|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309055|NCT02625207|Secondary|Part 2: Average Plasma Concentration (Cavg) of Maraviroc|Cavg is the average plasma concentration of maraviroc during the 0 to 24 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 24 hours (AUC [0-24]) divided by 24.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309056|NCT02625207|Secondary|Part 1: Average Plasma Concentration (Cavg) of Maraviroc|Cavg is the average plasma concentration of maraviroc during the 0 to 12 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 12 hours (AUC [0-12]) divided by 12.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1309057|NCT02625207|Primary|Part 1: Metabolite to Parent Ratio for Area Under the Concentration-Time Curve From Time 0 to 12 Hours for Maraviroc and Its Metabolites (MRAUC12)|MRAUC12 is the ratio of AUC12 of maraviroc to AUC12 of maraviroc's metabolites. Metabolites of Maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573. AUC12 is the area under the plasma concentration-time profile from time 0 to 12 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1309058|NCT02625207|Primary|Part 2: Area Under The Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24]) of Maraviroc|AUC (0-24) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1309059|NCT02625207|Primary|Part 1: Area Under The Plasma Concentration-Time Curve From Time 0 to 12 Hours (AUC [0-12]) of Maraviroc|AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|Pharmacokinetic (PK) parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1309060|NCT02624791|Secondary|Operational Composite Score|Z-score composite of operational testing outcomes|1 day laboratory study||||Z score||Standard Deviation|Mean
1309061|NCT02624791|Primary|Tactical Composite Score|Z-score composite of tactical testing outcomes|1 day laboratory study||||Z score||Standard Deviation|Mean
1309062|NCT02623361|Secondary|Patient Satisfaction|"patient questionaire, patients are contacted 48 h after surgery~patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating not satisfied at all and 10 indicating very satisfied"|48 hours||||units on the numeric rating scale (0-10)||Standard Deviation|Mean
1309063|NCT02623361|Secondary|Leg Strength at Discharge From Ambulatory Center, Surgical Leg|measurement of quadriceps strength (Force) using a dynamometer|2 hours after surgery||||Newton||Standard Deviation|Mean
1309064|NCT02623361|Primary|Pain|highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)|within one hour after surgery|Exclusion criteria for enrollment included age younger than 18 years, contraindications for regional anesthesia, pre-existing neurologic deficits of the lower extremity, and a history of chronic pain requiring chronic opioid medication.|||units on the numeric rating scale (0-10)||Standard Deviation|Mean
1309065|NCT02622568|Primary|Size of Verrucae (Warts)|Diameter of verrucae (warts) at week 12|12 weeks|Only participants completing study are included in analysis.|||millimeters||Standard Deviation|Mean
1309066|NCT02622321|Secondary|Plasma Trough Concentration of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated Enzyme Linked Immunosorbent Assay (ELISA). The lower limit of quantification (LLOQ) was 100 nanograms per milliliter (ng/mL).|Arm A: Pre-dose (0 hour [hr]) on Weeks 1-5, 7, 9, 13, 17, 21, 25, 33, 41, 49; Arm B: Pre-dose (0 hr) on Weeks 25-29, 31, 33, 37, 41; Arm C: Pre-dose (0 hr) on Weeks 1-5, 7, 9, 13, 17, 21, 25, 33, 41; Arm D: Pre-dose (0 hr) on Weeks 1-5, 7, 9, 13|Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of emicizumab and had at least one post-dose emicizumab concentration result. Data collection was not planned for time-points in the treatment arms where 0 participants were analyzed.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1309067|NCT02622321|Secondary|Percentage of Participants With Anti-Emicizumab Antibodies||Baseline up to approximately 1 year|All emicizumab participants included Arms A, C, and D and Arm B participants who switched to receive emicizumab (Arm Bemi). Overall number of participants analyzed=participants with at least one post-baseline antibody assessment.|||percentage of participants|||Number
1309086|NCT02621047|Secondary|Apparent Oral Clearance (CL/F) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
1309068|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Hemophilia-Specific Quality of Life – Short Form (Haemo-Qol-SF) Questionnaire Total Score in Adolescents Participants (12-17 Years Old)|The Haemo-QoL-SF contains 35 items, which cover nine domains considered relevant for the children’s health-related quality of life (physical health, feelings, view of yourself, family, friends, other people, sports and school, dealing with hemophilia and treatment). Items are rated with five respective response options: never, seldom, sometimes, often, and always. Haemo-QoL-SF total score range from 0 to 100, where lower scores reflect better health-related quality of life. Data for this outcome was to be analyzed only if >3 participant (in each arm) have available data.|Week 25|ITT population. Overall number of participants analyzed=participants with available for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309069|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: EQ-5D-5L Index Utility Score|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L health state profile is designed to record the participant's current health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses from the five domains are used to calculate a single utility index value ranging from 1 to 5, where 1 indicates better health state (no problems) and 5 indicates worst health state (confined to bed).|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309070|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale Score|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309071|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Haem-A-QoL Questionnaire Total Score in Adult Participants (>/=18 Years Old)|Haem-A-QoL questionnaire has been developed and used in hemophilia A participants. As a hemophilia-specific questionnaire, this measure assesses very specific aspects of dealing with hemophilia. This questionnaire consists of items pertaining to 10 domains specific to living with hemophilia. The 10 domains are: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain range from 0 to 100 with lower scores reflective of better quality of life. Haem-A-QoL Questionnaire Total Score is the average of the all domain scores and range from 0 to 100, with lower scores reflective of better quality of life.|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309072|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Hemophilia-Specific Quality of Life (Haem-A-QoL) Questionnaire Physical Health Score in Adult Participants (>/=18 Years Old)|Haem-A-QoL questionnaire has been developed and used in hemophilia A participants. As a hemophilia-specific questionnaire, this measure assesses very specific aspects of dealing with hemophilia. This questionnaire consists of items pertaining to 10 domains specific to living with hemophilia. The 10 domains are: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain range from 0 to 100 with lower scores reflective of better quality of life. Physical Health domain score is reported (range 0 to 100, with lower scores reflective of better physical health).|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309073|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for Treated Target Joint Bleeds|Number of treated target joint bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated target joint bleeds included treated (with coagulation factors) joint bleeds in a target joint, defined as a joint in which greater than or equal to (>/=) 3 treated joint bleeds occurred during the last 24 weeks prior to study entry. Bleeds due to surgery/procedure are excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||treated target joint bleeds per year||95% Confidence Interval|Number
1309074|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for Treated Spontaneous Bleeds|Number of treated spontaneous bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated spontaneous bleeds were defined as treated (with coagulation factors) bleeds with no known contributing factor (e.g., trauma, surgery).|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||treated spontaneous bleeds per year||95% Confidence Interval|Number
1309075|NCT02622321|Secondary|Arm C (Prophylactic Treatment): Emicizumab and Arm Cnis: Prophylactic Bypassing Agents in NIS BH29768: ABR for Treated Bleeds|Number of treated bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated bleeds were defined as a bleed for which coagulation factors were administered. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of treated bleeds prior to study entry, while receiving prophylactic bypassing agents during NIS BH29768 (Arm Cnis), with ABR of treated bleeds on emicizumab prophylaxis (in this study) (Arm C) was reported.|For Arm Cnis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm C: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm C NIS population included all Arm C participants who participated in NIS BH29768 before study entry and received prophylactic bypassing agents during NIS BH29768.|||treated bleeds per year||95% Confidence Interval|Number
1309087|NCT02621047|Secondary|t1/2 of Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins. t1/2 = the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Geometric Coefficient of Variation|Geometric Mean
1309076|NCT02622321|Secondary|Arm C (Prophylactic Treatment): Emicizumab and Arm Cnis: Prophylactic Bypassing Agents in NIS BH29768: ABR for All Bleeds|Number of all bleeds over the efficacy period was assessed through ABR using an NB regression model. All bleeds included both treated (with coagulation factors) and not treated bleeds. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of all bleeds prior to study entry, while receiving prophylactic bypassing agents during NIS BH29768 (Arm Cnis), with ABR of all bleeds on emicizumab prophylaxis (in this study) (Arm C) was reported.|For Arm Cnis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm C: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm C NIS population included all Arm C participants who participated in NIS BH29768 before study entry and received prophylactic bypassing agents during NIS BH29768.|||all bleeds per year||95% Confidence Interval|Number
1309077|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for Treated Joint Bleeds|Number of treated joint bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated joint bleeds were defined as treated bleeds in a joint associated with unusual sensation (aura) in a joint, in combination with another symptom: unusual sensation, swelling/warmth, pain/decreased range of motion (RoM), difficulty moving the joint. Bleeds due to surgery/procedure were excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||treated joint bleeds per year||95% Confidence Interval|Number
1309078|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm Anis: Episodic Bypassing Agents in NIS BH29768: ABR for Treated Bleeds|Number of treated bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated bleeds were defined as a bleed for which coagulation factors were administered. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of treated bleeds prior to study entry, while receiving episodic bypassing agents during NIS BH29768 (Arm Anis), with ABR of treated bleeds on emicizumab prophylaxis (in this study) (Arm A) was reported.|For Arm Anis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm A: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm A NIS population included all Arm A participants who participated in NIS BH29768 before study entry and received episodic bypassing agents during NIS BH29768.|||treated bleeds per year||95% Confidence Interval|Number
1309079|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm Anis: Episodic Bypassing Agents in NIS BH29768: ABR for All Bleeds|Number of all bleeds over the efficacy period was assessed through ABR using an NB regression model. All bleeds included both treated (with coagulation factors) and not treated bleeds. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of all bleeds prior to study entry, while receiving episodic bypassing agents during non-interventional study (NIS) BH29768 (NCT02476942) (Arm Anis), with ABR of all bleeds on emicizumab prophylaxis (in this study) (Arm A) was reported.|For Arm Anis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm A: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm A NIS population included all Arm A participants who participated in NIS BH29768 before study entry and received episodic bypassing agents during NIS BH29768.|||all bleeds per year||95% Confidence Interval|Number
1309080|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for All Bleeds|Number of all bleeds over the efficacy period was assessed through ABR using an NB regression model. All bleeds included both treated (with coagulation factors) and not treated bleeds. Bleeds due to surgery/procedure were excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||all bleeds per year||95% Confidence Interval|Number
1309081|NCT02622321|Primary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Annualized Bleed Rate (ABR) for Treated Bleeds|Number of treated bleeds over the efficacy period was assessed through ABR using a negative binomial (NB) regression model. Treated bleeds were defined as a bleed for which coagulation factors were administered. Bleeds due to surgery/procedure were excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Intent-to-treat (ITT) population defined as all participants who were randomized to Arm A or Arm B.|||treated bleeds per year||95% Confidence Interval|Number
1309082|NCT02621047|Secondary|Fraction of Drug Unbound (fu) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. fu = ratio of unbound alectinib to total alectinib multiplied by 100.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||percentage of total alectinib||Geometric Coefficient of Variation|Geometric Mean
1309083|NCT02621047|Secondary|Vz/F for Unbound Alectinib|Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters||Geometric Coefficient of Variation|Geometric Mean
1309084|NCT02621047|Secondary|Apparent Volume of Distribution (Vz/F) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters||Geometric Coefficient of Variation|Geometric Mean
1309085|NCT02621047|Secondary|CL/F of Unbound Alectinib|Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
1309088|NCT02621047|Secondary|Apparent Terminal Half-life (t1/2) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. t1/2 = the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Geometric Coefficient of Variation|Geometric Mean
1309090|NCT02621047|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Full Range|Median
1309091|NCT02621047|Secondary|AUC 0-last of Unbound Alectinib + M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1309092|NCT02621047|Secondary|AUC 0-last of Total Alectinib + M4|Total alectinib + M4 = unbound alectinib + M4 plus alectinib + M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1309093|NCT02621047|Secondary|AUC 0-last of Unbound M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309094|NCT02621047|Secondary|AUC 0-last of Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309095|NCT02621047|Secondary|AUC 0-inf of Unbound Alectinib + M4|AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1309096|NCT02621047|Secondary|AUC 0-inf of Total Alectinib + M4|Total alectinib + M4 = unbound alectinib + M4 plus alectinib + M4 bound to plasma proteins. AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1309097|NCT02621047|Secondary|AUC 0-inf of Unbound M4|AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309098|NCT02621047|Secondary|AUC 0-inf of Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins. AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309099|NCT02621047|Secondary|Cmax of Unbound Alectinib + M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1309100|NCT02621047|Secondary|Cmax of Total Combined Alectinib and M4 (Alectinib + M4)|Total alectinib + M4 = unbound alectinib + M4 plus alectinib + M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1309101|NCT02621047|Secondary|Cmax of Unbound M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309102|NCT02621047|Secondary|Cmax of Total Metabolite of Alectinib (M4)|Total M4 = unbound M4 plus M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309103|NCT02621047|Primary|AUC 0-last for Unbound Alectinib||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309104|NCT02621047|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measureable Concentration (AUC 0-last) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309105|NCT02621047|Primary|AUC 0-inf for Unbound Alectinib|AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309106|NCT02621047|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC 0-inf) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. AUC 0-inf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309107|NCT02621047|Primary|Cmax of Unbound Alectinib||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309130|NCT02618772|Other Pre-specified|Time That the Participant Remained in Hospital After Procedure (Mins)|Length of stay in the emergency department, measured from the end of the procedure to the time of discharge.|Day 1: at discharge from emergency department (i.e. same day)||||minutes||Standard Deviation|Mean
1309108|NCT02621047|Primary|Maximum Observed Plasma Concentration (Cmax) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population included all participants who were enrolled in the study, received study treatment, and had pharmacokinetic data available.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1309109|NCT02621034|Primary|Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval||72 hours||||units on a scale||Standard Deviation|Mean
1309110|NCT02621034|Primary|Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals||72 hours||||units on a scale||Standard Deviation|Mean
1309111|NCT02621034|Primary|Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval|The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10).|6 hours||||units on a scale||Standard Deviation|Mean
1309112|NCT02620683|Secondary|Topical Anesthesia Effect Contralateral Lower Lip|"Investigator will administer 5-6 drops of the lidocaine to the contralateral lower lip and immediately ask if signs of numbness are present on the lip.~Patients reported presence of numbness lower lip-Yes or No"|At time of administration|Unable to administer in this fashion because Lidocaine would not remain on lip surface therefore data were not collected||||||
1309113|NCT02620683|Secondary|Number of Minutes to Anesthesia Symptoms of Lower Lip|"Patients were instructed to record the time when they experienced the initial indication of anesthesia signs in the lower lip. This was reported as the number of minutes following nerve block injection.~For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered was performed."|Patient report of anesthesia symptom onset following injection||||minutes||Standard Deviation|Mean
1309114|NCT02620683|Secondary|Pain Intensity Scores|"Patients reported pain level immediately after injection of lidocaine via a Likert type scale where 1 = No Pain and 10 = Worst Pain Imaginable.~For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered was performed."|Immediately after lidocaine injection||||units on a scale||Standard Deviation|Mean
1309115|NCT02620683|Primary|Lidocaine Blood Levels 30 Minutes Post Injection|Lidocaine blood levels were obtained 30 minutes post injection micro g/L The difference between injection type– 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon rank sum tests with Proc NPAR1WAY (SAS v 9.3). Statistical significance was set as P < 0.05 for all outcomes.|30 minutes post injection||||ug/L||Standard Deviation|Mean
1309116|NCT02619812|Primary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|30 days|Data were not collected.||||||
1309117|NCT02619812|Primary|Stool Frequency|Stool frequency was self reported in a daily bowel pattern diary for 30 days.|30 days|Data were not collected.||||||
1309118|NCT02619799|Secondary|Perioperative Side Effects|through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.|through out the intraoperative period and first 12 postoperative hours.||||participants|||Number
1309119|NCT02619799|Secondary|Duration of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.||||time in minutes||Standard Deviation|Mean
1309120|NCT02619799|Secondary|Onset of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.||||time in minutes||Standard Deviation|Mean
1309121|NCT02619799|Secondary|Duration of Sensory Blockade|the duration of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..||||time in minutes||Standard Deviation|Mean
1309122|NCT02619799|Secondary|Onset of Sensory Blockade|the onset time of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..||||time in minutes||Standard Deviation|Mean
1309123|NCT02619799|Primary|Duration of Postoperative Analgesia|pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.|first 12 hours after completion of surgery.||||time in minutes||Standard Deviation|Mean
1309124|NCT02619591|Primary|Pneumothorax (Positive or Negative)|The presence of a pneumothorax at the time of the ultrasound|up to 20 minutes||||participants|||Number
1309125|NCT02619409|Primary|Duration of Motor Block|(hip felxion) of the non operative leg|12 hours||||hours||Standard Deviation|Mean
1309126|NCT02619409|Primary|Duration of Sensory Block|Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase|12 hours||||hours||Standard Deviation|Mean
1309127|NCT02618772|Other Pre-specified|Guardian/Parent's Prediction is Respect to Intervention Drug|This is a measure how how many times the parent/guardian was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: parent asked immediately after procedure complete||||Times correct|||Number
1309128|NCT02618772|Other Pre-specified|Physician's Prediction is Respect to Intervention Drug|This is a measure how how many times the physician was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: physician asked immediately after procedure finished||||Times correct|||Number
1309129|NCT02618772|Other Pre-specified|Length of Procedure (Mins)|This is a measure of the length of the procedure (suturing) in minutes.|Day 1||||minutes||Standard Deviation|Mean
1313618|NCT02475031|Secondary|Nausea Scores at 48 Hours|Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe.|up to 48 hours||||units on a scale||Standard Error|Mean
1309131|NCT02618772|Secondary|Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.~FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
1309132|NCT02618772|Secondary|Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.~FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
1309133|NCT02618772|Secondary|Per-Protocol: Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
1309134|NCT02618772|Secondary|Intention to Treat (ITT): Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
1309135|NCT02618772|Secondary|Per-Protocol: State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
1309136|NCT02618772|Secondary|Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
1309137|NCT02618772|Secondary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: Baseline, Intervention & Lidocaine|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
1309147|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
1309280|NCT02613910|Primary|Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities|12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
1309138|NCT02618772|Secondary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During Baseline, Intervention & Lidocaine|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
1309139|NCT02618772|Primary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
1309140|NCT02618772|Primary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
1309141|NCT02618512|Primary|Safety and Tolerability of SBC-103|The planned primary endpoint of this study was safety and tolerability of SBC-103 in patients with MPS IIIB, as measured by Number of participants with treatment-emergent adverse events, including serious adverse events; infusion-associated reactions; incidence of antidrug antibodies, clinical laboratory tests, cerebrospinal fluid findings, vital signs, and prior and concomitant medications|Planned duration was baseline to 164 weeks but due to early termination of the study, actual is 96 weeks.||||Participants|||Count of Participants
1309142|NCT02617901|Primary|Bone Age as Assessed by DXA|Interclass correlation (for observer agreement between radiographs and DXA)|18 months|Children presenting to Endocrine Clinic|||Intraclass correlation|||Number
1309143|NCT02617888|Primary|Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging|The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA. In addition, changes in DNA double-strand breaks from baseline following cardiac testing in the observational arm is being assessed in an observational manner.|Change from baseline double strand DNA breaks at 30 minutes post-imaging|Female patients 18 years or older who were clinically referred to undergo coronary CT angiography between August 2012 and July 2014 at Walter Reed National Military Medical Center (Bethesda, Maryland) were eligible for enrollment.|||gamma-H2AX foci in blood lymphocytes||Standard Deviation|Mean
1309144|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
1309145|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
1309146|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
1309727|NCT02600351|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.|Up to 24 weeks|Full Analysis Set by Actual Treatment|||percentage of participants|||Number
1309148|NCT02617784|Secondary|CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
1309149|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
1309150|NCT02617784|Secondary|CLr of Oseltamivir in CAPD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
1309151|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose|PK Analysis Population.|||L/h||Standard Deviation|Mean
1309152|NCT02617784|Secondary|CL/F of Oseltamivir in CAPD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose|PK Analysis Population.|||L/h||Standard Deviation|Mean
1309153|NCT02617784|Secondary|Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.|||hours||Standard Deviation|Mean
1309154|NCT02617784|Secondary|Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h).|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.|||1/h||Standard Deviation|Mean
1309155|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||hours||Standard Deviation|Mean
1309156|NCT02617784|Secondary|Tmax of Oseltamivir in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||hours||Standard Deviation|Mean
1309157|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||ng/mL||Standard Deviation|Mean
1309158|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||ng/mL||Standard Deviation|Mean
1309159|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants|Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population.|||ng/mL||Standard Deviation|Mean
1309172|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309160|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of osteltamivir dose||Standard Deviation|Mean
1309161|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
1309162|NCT02617784|Secondary|Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population; n = number of participants included in the specific dose analysis.|||L/h||Standard Deviation|Mean
1309163|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
1309164|NCT02617784|Secondary|Renal Clearance (CLr) of Oseltamivir in HD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
1309165|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||L/h||Standard Deviation|Mean
1309166|NCT02617784|Secondary|Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||L/h||Standard Deviation|Mean
1309167|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||hours||Standard Deviation|Mean
1309168|NCT02617784|Secondary|Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||hours||Standard Deviation|Mean
1309169|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; n = number of participants included at specified timepoints in the analysis.|||ng/mL||Standard Deviation|Mean
1309170|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; number (n) equals (=) number of participants included at specified timepoints in the analysis.|||ng/mL||Standard Deviation|Mean
1309171|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309173|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309174|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309175|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
1309176|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
1309177|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose|PK Analysis Population (Second Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
1309178|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
1309179|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309180|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309181|NCT02617784|Primary|AUC of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309182|NCT02617784|Primary|Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
1309183|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
1309184|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
1309185|NCT02617784|Primary|Cmax of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose|PK Analysis Population (Second Dose Subpopulation): All participants who completed treatment and provided evaluable data during the second dose assessment period.|||ng/mL||Standard Deviation|Mean
1309186|NCT02617784|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose|Pharmacokinetic (PK) Analysis Population (First Dose Subpopulation): All participants who completed treatment and provided evaluable data during the first dose assessment period.|||ng/mL||Standard Deviation|Mean
1309204|NCT02615990|Secondary|Incidence of Catheter Disruption|Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309205|NCT02615990|Secondary|Incidence of Physical Instability|Incidence of physical instability with be calculated as the number of falls per participant while hospitalized. Data will be presented as the number of falls per participant per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309187|NCT02617667|Primary|Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days|"The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to no dryness and 100% corresponds to maximum dryness."|Baseline to 113 Days|Full analysis set population for worst eye. Worst eye: Eyes were eligible for analysis if they met all inclusion criteria. If both eyes qualified, the worst eye was taken as the eye with higher (worse) staining at Visit 1. If staining was the same, the right eye was taken.|||units on a scale||Standard Deviation|Mean
1309188|NCT02617667|Primary|Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days|The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.|Baseline to 113 Days|Full analysis set population for worst eye. Worst eye: Eyes were eligible for analysis if they met all inclusion criteria. If both eyes qualified, the worst eye was taken as the eye with higher (worse) staining at Visit 1. If staining was the same, the right eye was selected as the worst eye.|||units on a scale||Standard Deviation|Mean
1309189|NCT02616523|Other Pre-specified|Complication|complications such as obstipation in the postoperative period|up to two weeks|||||||
1309190|NCT02616523|Secondary|Neuropathic Pain (Pain Questionnaire) dn4|Pain questionnaire dn4 will be send to participants after two months of surgery to evaluate the neuropathic pain. There are minimum 0 points and maximum 10 points. If the score is 4 or higher then the pain is likely to be neuropathic pain.|two months after the surgery||||units on a scale||Standard Deviation|Mean
1309191|NCT02616523|Secondary|Consumption of Piritramide|consumption of piritramide (mg) in the recovery room|one hour after the operation||||mg||Standard Deviation|Mean
1309192|NCT02616523|Primary|Consumption of Fentanyl|consumption of fentanyl (mg) during the procedure|time of the operation||||mg||Standard Deviation|Mean
1309193|NCT02616250|Primary|Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator’s Global Assessment (IGA):|Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)|week 12/Hour 3|Intent To Treat (ITT) Population|||Participants|||Count of Participants
1309194|NCT02615990|Secondary|Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility|The number of participants discharged to am acute rehabilitation facility will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309195|NCT02615990|Secondary|Number of Patients Discharged From Hospital to a Long Term Care Facility|The number of participants discharged to a long term care facility will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309196|NCT02615990|Secondary|Number of Patients Discharged From Hospital to Skilled Nursing Facility|The number of participants discharged to a skilled nursing home will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309197|NCT02615990|Secondary|Number of Patients Discharged From Hospital to Home|The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309198|NCT02615990|Secondary|Mid-leg Muscle Circumference|Mid-leg muscle circumference will be measure using a metric tape measure at hospital admission and again just prior to discharge. Data will be presented as the change in muscle circumference (cm) over time.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309199|NCT02615990|Secondary|Independent Ambulation|The number of hospital days required for the participant to regain independent ambulation (the ability to walk 5 meters unassisted) with be measured and presented as total days.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309200|NCT02615990|Secondary|Assessment of Participant Mobility|The ICU Mobility Scale ranks a participant’s mobility on a scale of 0-32, were a score of zero is a completely non-mobile individual and a score of 32 is a fully ambulatory individual. Data will be collected at the time of discharge. The data are presented as units on a scale.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309201|NCT02615990|Secondary|Fall Risk|Participant fall risk will be determined prior to discharge using the Berg Balance Scale to assess impairment of balance function through the completion of several functional tasks. The data are presented as units on a scale. The higher the number the lower the fall risk.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309202|NCT02615990|Secondary|Measure of Muscle Power|The Muscle Research Council Muscle Scale will be used to determine actual muscle power generation vs the anticipated power generation prior to discharge. Total score: 0 - 5, 5 is normal muscle function. Data are presented as units on a scale.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309203|NCT02615990|Secondary|Measure of Physical Capacity|Kansas University Hospital Physical Therapy Acute Care Functional Outcome Tool will be utilized to assess the participant’s overall physical function prior to discharge. . Total score: 0 - 32, usually divided by 25%, 50%, >75% (minimum, moderate, maximum functionality). The higher the score, the great physical function the participant has.|At discharge (up to 1 year)|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309206|NCT02615990|Secondary|Incidence of Pressure Ulcers|Incidence of pressure ulcers determined by physical observation. Total incidence will be compared between groups and presented as a total count of pressure ulcer diagnoses per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309207|NCT02615990|Secondary|Incidence of Deep Vein Thrombosis (DVT)|Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309208|NCT02615990|Secondary|Incidence of Urinary Tract Infections While Hospitalized|Incidence of urinary tract infection during hospitalization will be determined by clinical symptoms to include temperature of > 100.8 degrees F, WBC> 12000 WBC/MM3, patient complaints of pain, positive urine culture. Total incidence will be compared between groups and presented as a total count of urinary tract infection diagnoses per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309209|NCT02615990|Secondary|Incidence of Pneumonia While Hospitalized|Incidence of pneumonia while hospitalized will be determined by clinical symptoms to include temperature >100.8 degrees F, WBC>12,000 WBC/mm3 , PaO2/Fio2 ratio < 300 mmHg, positive respiratory culture for organisms and chest x-ray indicative of pneumonia. Total incidence will be compared between groups and presented as a total count of pneumonia diagnoses per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309210|NCT02615990|Secondary|Hospital Length of Stay|The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309211|NCT02615990|Secondary|ICU Length of Stay|The duration of stay in the Trauma ICU will be measured and compared between groups. Data will be presented as mean number of days in the ICU.|Up to three months|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309212|NCT02615990|Primary|Orthostatic Tolerance During Ambulation|Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from standing to full ambulation. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial unassisted standing and then during each treatment session there after until discharge. Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from standing to full ambulation.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309213|NCT02615990|Primary|Orthostatic Tolerance During Verticalization|Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from lying down to standing. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial verticalization after injury and at each treatment session there after until they achieve ambulation (the ability to move without assistance). Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from lying to standing.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
1309214|NCT02615743|Secondary|Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.|The difference in the change of cACT score from first study visit to the third study visit will be compared between the two study groups. Asthma Control Test (ACT) provides a numerical score to determine if asthma symptoms are well controlled. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well controlled asthma.|30 days|There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.|||units on a scale||Standard Deviation|Mean
1309215|NCT02615743|Secondary|Adherence|Percent adherence will be calculated as observed medication actuations from electronic adherence monitors over expected use (the latter is = prescribed daily regimen number of observation days)|30 days|There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.|||percent adherence||95% Confidence Interval|Mean
1309216|NCT02615743|Primary|Acceptability|"The rating of the monitoring device will be compared between groups based on responses to a questionnaire asking about acceptability and preferences to determine if there is a difference in the favorability We determined this by the number of participants who found text message reminders helpful to avoid missing doses. After 30 days caregivers of control group participants were given the option to receive daily text messages; they were asked about acceptability 30 days later."|30 days (intervention group) 60 days (control group)|There were 6 participants missing from the intervention group due to loss to followup. There were only 5 caregivers of participants in the control group who agreed to receive daily text messages.|||Participants|||Count of Participants
1309217|NCT02615743|Primary|Feasibility|The number and percentage of patients that continue to use the monitoring device throughout the month will be compared between the intervention and control groups.|30 days||||Participants|||Count of Participants
1309218|NCT02615717|Secondary|Beck Anxiety Inventory (BAI)|Self-report measure of 20 symptoms of anxiety Range: 0-60 all items summed Higher score indicates higher severity|within three days||||units on a scale||Standard Deviation|Mean
1309219|NCT02615717|Secondary|Patient Health Questionnaire (PHQ-9)|Self-report measure of 9 symptoms related to depression Range: 0-27, all items summed Higher score indicates higher severity|within three days||||units on a scale||Standard Deviation|Mean
1309220|NCT02615717|Secondary|PTSD Checklist (PCL-5)|Self-report of PTSD symptom severity Scale range: 0-80 Total score utilized, all items summed. Higher score indicates higher severity.|within three days||||units on a scale||Standard Deviation|Mean
1309221|NCT02615717|Primary|Clinician-Administered PTSD Scale (CAPS-5)|Assesses symptoms and severity of Posttraumatic Stress Disorder Range: 0-80; total score utilized. Higher values indicate higher severity Subscales are summed to create a total score; subscales made up of different facets of PTSD.|within three days||||units on a scale||Standard Deviation|Mean
1309224|NCT02614586|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Part 2: Day 1 of Intervention Period 1 up to Day 21|Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.||||||
1309225|NCT02614586|Primary|Change From Baseline in P50 Ratio S2/S1 at Central (Cz) Electrode Following Administration of TAK-058|Participants were planned to check for P50 gating ratio. Stimulus signal of 90 decibel pulses of 0.1 millisecond (msec) was to be generated and recorded the event-related potential waveforms. 32 pairs of auditory clicks were to be presented every 10 seconds, with a 500 msec interclick interval. S1 is defined as the conditioning P50 wave with the most positive peak between 30 and 90 msec after the conditioning stimulus. S2 is defined as the test P50 wave with the positive peak after the test stimulus that was closest in latency to the conditioning P50. Amplitude is the difference between the positive peak and the preceding negative trough for both waves. The data from the vertex (Cz site) was to be collected and the P50 gating ratio (S2/S1) was to be calculated as the ratio of the test P50 amplitude to the conditioning P50 amplitude.|Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.|Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.||||||
1309226|NCT02614469|Secondary|Safety Assessment: Adverse Events|Number of participants with adverse events after study drug administration|Up to 10 days after first study drug administration at Day 1 of Period 1||||participants|||Number
1309227|NCT02614469|Secondary|Safety Assessment (Vital Signs)|Number of participants with clinically significant findings in vital signs by investigator after study drug administration.|Up to 10 days after first study drug administration at Day 1 of Period 1||||participants|||Number
1309228|NCT02614469|Primary|Baseline Corrected T1/2: Baseline Corrected Apparent Terminal Half-life|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|Baseline Corrected T 1/2 values for 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.|||hr||Standard Deviation|Mean
1309229|NCT02614469|Primary|Baseline Corrected Tmax: Baseline Corrected Time of Maximum Serum Concentration|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 h pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose||||hr||Full Range|Median
1309230|NCT02614469|Primary|Baseline Corrected AUC (0-inf): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose|Baseline Corrected AUC (0-inf) values of 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.|||mg*hr/dL||Standard Deviation|Mean
1309231|NCT02614469|Primary|Baseline Corrected AUC (0-t): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Serum Concentration)|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||mg*hr/dL||Standard Deviation|Mean
1309232|NCT02614469|Primary|Baseline Corrected Cmax: Baseline Corrected Maximum Serum Concentration|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||mg/dL||Standard Deviation|Mean
1309233|NCT02614469|Primary|T1/2: Apparent Terminal Half-life||-12 to 0 pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|T 1/2 of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.|||hr||Standard Deviation|Mean
1309234|NCT02614469|Primary|Tmax: Time of Maximum Serum Concentration||-12 to 0 hr pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||hr||Full Range|Median
1309235|NCT02614469|Primary|AUC (0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity||-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|AUC (0-inf) of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.|||mg*hr/dL||Standard Deviation|Mean
1309236|NCT02614469|Primary|AUC (0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Plasma Concentration)||-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||mg*hr/dL||Standard Deviation|Mean
1309237|NCT02614469|Primary|Cmax: Maximum Observed Serum Urate Concentration||-12 to 0 hrs pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post-dose||||mg/dL||Standard Deviation|Mean
1309238|NCT02614222|Secondary|Undesired Muscle Weakness Measured Subjectively|Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.|During hospital stay (maximum 3 days)|This data was not collected for 6 (out of 27) participants.|||Participants|||Count of Participants
1309239|NCT02614222|Secondary|Incidence of Postoperative Nausea and Vomiting|Number of participants that reported postoperative nausea and vomiting|During hospital stay (maximum 3 days)|This data was not collected for 4 (out of 27) participants.|||Participants|||Count of Participants
1309241|NCT02614222|Secondary|Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire|Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.|Post-op day 1|This data was not collected for 5 (out of 27) participants.|||Units on a Scale||Standard Deviation|Mean
1309242|NCT02614222|Secondary|Number of Times Needle Needs Repositioning||Immediately following intervention (within 2 hours)|Data for this outcome measure was not collected.||||||
1309243|NCT02614222|Secondary|Number of Attempts|Number of instrument pricks before target is reached|Immediately following intervention (within 2 hours)|This data was not collected for 3 (out of 27) participants.|||Attempts||Standard Deviation|Mean
1309244|NCT02614222|Secondary|Clinician Rating of the Device|Clinician rates the device on a scale of 1-10. This also includes a questionnaire.|Immediately following intervention (within 2 hours)|Data for this outcome measure was not collected||||||
1309245|NCT02614222|Primary|Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block||Immediately after intervention (within 2 hours)||||Minutes||Standard Deviation|Mean
1309246|NCT02614079|Primary|Number of Participants With Positive Collision|Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.|Day 1|5 participants completed DSSEP testing after placement of SCS Trial leads.|||Participants|||Count of Participants
1309247|NCT02613910|Secondary|Titer of Human Anti-human Antibody|Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.|Up to Week 72|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309248|NCT02613910|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Immune Response|Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.|Up to Week 72|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309249|NCT02613910|Secondary|Cumulative Dose of Corticosteroids|Cumulative dose of corticosteroids was calculated to evaluate steroid exposure and reductions in steroid dose while maintaining disease control. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309250|NCT02613910|Secondary|Number of Days a Participant is Off Steroid Therapy by Week 60|Number of days, a participant did not require steroid therapy was observed and summarized. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309251|NCT02613910|Secondary|Number of Days Minimal Steroid Therapy is Maintained by Week 60|Minimal steroid therapy is an oral prednisone/prednisolone dose of <= 10 mg/day. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309252|NCT02613910|Secondary|Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course During the Individualized Follow-up Period|It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309253|NCT02613910|Secondary|Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course|It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309254|NCT02613910|Secondary|Number of Participants Who do Not Flare/Relapse on Minimal Steroid Therapy|It was planned to assess as participants who achieved remission on minimal steroid therapy and did not subsequently have a flare/relapse of disease by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309255|NCT02613910|Secondary|Number of Participants Who do Not Flare/Relapse|It was planned to assess participants with out an appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or an extension (worsening) of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309256|NCT02613910|Secondary|Time to Initial Flare/Relapse by Week 60|Time to initial flare/relapse is time from Baseline to the time of appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. The appearance of 1 or 2 new lesions was not to be considered a flare/relapse. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309257|NCT02613910|Secondary|Duration of Remission After Completing the Ofatumumab SC Treatment Course|Duration of remission after completing the ofatumumab SC treatment course was to be assessed during the individualized Follow-up period for participants who were in remission on minimal steroid therapy by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309281|NCT02613910|Primary|Number of Participants With Vital Signs of Clinical Concern|Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant.|Up to Week 60|Safety Population.|||Participants|||Number
1309747|NCT02598583|Secondary|Change From Baseline in Haptoglobin||Baseline to Day 169||||g/L||Standard Deviation|Mean
1309258|NCT02613910|Secondary|Time to Remission on Minimal Steroid Therapy|Time to remission on minimal steroid therapy is the time from Baseline to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309259|NCT02613910|Secondary|Number of Participants Achieving Remission on Minimal Steroid Therapy|Remission is defined as absence of new or non-healing (established) lesions for >=8 weeks and minimal steroid therapy is defined as an oral prednisone/prednisolone dose of <=10 mg/day. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309260|NCT02613910|Secondary|Number of Participants Achieving Remission While Off Steroid Therapy by Week 60|Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309261|NCT02613910|Secondary|Time to Remission Off Steroid Therapy by Week 60|Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309262|NCT02613910|Secondary|Number of Participants Achieving Sustained Remission on Minimal Steroid Therapy by Week 60|Sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309263|NCT02613910|Secondary|Duration of Remission on Minimal Steroid Therapy|Duration of remission on minimal steroid therapy is the total time (sum) of all periods of remission while on minimal steroid therapy (oral prednisone/prednisolone dose <=10 mg/day) up to Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309264|NCT02613910|Secondary|Time to Sustained Remission on Minimal Steroid Therapy|Time to sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >= 8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309265|NCT02613910|Primary|Change From Baseline in Immunoglobulin (Ig) A, IgM, and IgG Levels|Blood samples for IgA, IgM, and IgG analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309266|NCT02613910|Primary|Number of Participants With Laboratory Results of Potential Clinical Concern|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant.|Up to Week 156|Safety Population.|||Participants|||Number
1309267|NCT02613910|Primary|Change From Baseline in Specific Gravity of Urine|Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of urine specific gravity. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309268|NCT02613910|Primary|Change From Baseline in Urine Power of Hydrogen (pH) at the Indicated Time Points|Urine samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of pH. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309269|NCT02613910|Primary|Number of Participants With Change in Urinalysis Results|Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of appearance, protein, glucose, leukocyte esterase, ketones, hemoglobin, microalbumin, creatinine, microalbumin:creatinine ratio and microscopy which included RBC/high powered field, WBC/ hight powered field, epithelial cells, trichomonas, bacteria, yeast, crystals, ammonium urates, mucous threads, amorphous sediment and casts. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309297|NCT02613871|Secondary|Percentage of Participants That Required HBV Therapy Up to Posttreatment Week 108||Up to Posttreatment Week 108|||||||
1309748|NCT02598583|Secondary|Change From Baseline in Free Hemoglobin||Baseline to Day 169||||mg/dL||Standard Deviation|Mean
1309270|NCT02613910|Primary|Change From Baseline in Creatinine Clearance (Calculated) at the Indicated Time Points|Blood samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309271|NCT02613910|Primary|Change From Baseline in Sodium, Potassium, Chloride, Calcium, Glucose, Bicarbonate and Blood Urea Nitrogen at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309272|NCT02613910|Primary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309273|NCT02613910|Primary|Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309274|NCT02613910|Primary|Change From Baseline in Total Protein and Albumin at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309275|NCT02613910|Primary|Change From Baseline in Red Blood Cell (RBC) Count and Nucleated RBCs at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309276|NCT02613910|Primary|Change From Baseline in CD4: CD8 Ratio at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309277|NCT02613910|Primary|Change From Baseline in White Blood Cell (WBC) Count, Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte, Platelet Count, Bands, Cluster of Differentiation (CD)19+ B-lymphocyte Counts, CD3, CD4 and CD8 at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309278|NCT02613910|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309279|NCT02613910|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
1309749|NCT02598583|Primary|Percent Change From Baseline in Lactate Dehydrogenase||Baseline to Day 169||||percent change||Standard Deviation|Mean
1309282|NCT02613910|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was planned to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to termination of study, analysis of this information was not performed.|Baseline (Week 0) and up to Week 60|Safety Population.||||||
1309283|NCT02613910|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate was to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained in the sitting position and at the time of the blood pressure measurement. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed|Baseline (Week 0) and up to Week 60|Safety Population.||||||
1309284|NCT02613910|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP were to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained after at least 5 minutes of rest. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Baseline (Week 0) and up to Week 60|Safety Population||||||
1309285|NCT02613910|Primary|Number of Participants With Injection Site Reactions|Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
1309286|NCT02613910|Primary|Number of Participants With Post-injection Systemic Reactions|All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
1309287|NCT02613910|Primary|Number of Participants With Infections|All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
1309288|NCT02613910|Primary|Number of Participants Withdrawn Due to Treatment-related AEs|Participants withdrawn due to treatment related AEs were to be summarized. One participant was enrolled into the study and was withdrawn early due to study termination. The participant was not withdrawn due to treatment-related AEs.|Up to Week 60|Safety Population.|||Participants|||Number
1309289|NCT02613910|Primary|Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported.|Up to Week 156|Safety Population. One participant was enrolled into the study and was withdrawn early due to study termination. No SAEs or AESIs were reported for this participant.|||Participants|||Number
1309290|NCT02613910|Primary|Number of Participants With Adverse Events Related to Ofatumumab SC|Participants with AEs related to ofatumumab were to be summarized. No adverse events related to ofatumumab were reported for the one participant enrolled.|Up to Week 60|Safety Population. No adverse events related to ofatumumab were reported for the one participant enrolled.|||Participants|||Number
1309291|NCT02613910|Primary|Number of Participants With Severe Adverse Events|Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled.|Up to Week 60|Safety Population. No safety events were reported for the one participant enrolled.|||Participants|||Number
1309292|NCT02613910|Primary|Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled.|Up to Week 60|Safety Population. No safety events were reported for the one participant enrolled.|||Participants|||Number
1309293|NCT02613871|Secondary|Percentage of Participants That Develop HCC Up to Posttreatment Week 108||Up to Posttreatment Week 108|||||||
1309294|NCT02613871|Secondary|Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During Treatment and up to Posttreatment Week 12||Up to Posttreatment Week 12|Full Analysis Set|||Percentage of participants|||Number
1309295|NCT02613871|Secondary|Fibrosis Status as Assessed by Fibroscan® at Posttreatment Weeks 60 and 108||Posttreatment Weeks 60 and 108|||||||
1309296|NCT02613871|Secondary|Fibrosis Status as Assessed by Fibroscan® at Posttreatment Week 12|"FibroScan® is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan® results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:~Presence of cirrhosis = FibroScan® result of > 12.5 kPa~Absence of cirrhosis = FibroScan® result of ≤ 12.5 kPa"|Posttreatment Week 12|Full Analysis Set|||kPa||Standard Deviation|Mean
1309304|NCT02613871|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as :~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)"|Up to Posttreatment Week 12|Full Analysis Set|||Percentage of participants|||Number
1309305|NCT02613871|Secondary|HCV RNA Change From Baseline While on Treatment||Baseline; Weeks 1, 2, 4, 8, and 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1309306|NCT02613871|Secondary|Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108||Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108|||||||
1309307|NCT02613871|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Weeks 1, 2, 4, 8, and 12|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
1309308|NCT02613871|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
1309309|NCT02613871|Primary|Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug||Up to 12 weeks|Safety Analysis Set: All participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
1309310|NCT02613871|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL)) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: All enrolled participants who took at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1309311|NCT02613403|Primary|Number of Participants Who Experienced AST/ALT >5x Upper Limit Normal (ULN)|The number of participants experiencing AST / ALT >5 times ULN from study week 4 until 2 weeks following completion of study therapy was determined.|From Study Week 4 up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment with ≥1 AST/ALT measurement subsequent to study week 4. One participant with prior SOF/LDV failure receiving MK-3682B + RBV withdrew from study before study week 4 and was excluded from analysis. Part B terminated prior to enrollment and was not included for analysis.|||Participants|||Count of Participants
1309312|NCT02613403|Primary|Number of Participants Who Experienced a Non-Overdose Event of Clinical Interest|The number of participants experiencing a non-overdose event of clinical interest (ECI) was determined. Non-overdose ECIs, assessed from initiation of study therapy through 14 days following study treatment cessation, included the following: 1) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >500 IU/L; or 2) AST or ALT >3x nadir value and >3X upper limit normal (ULN).|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
1309313|NCT02613403|Primary|Number of Participants Who Experienced an Accidental or Intentional Overdose Without Adverse Effect|The number of participants experiencing an accidental or intentional overdose without adverse effect was determined. Per study protocol, any occurrence of a participant receiving either MK-3682B or RBV at any dose higher than prescribed was considered an overdose. If this definition of overdose was met without any associated clinical symptoms or abnormal laboratory results, this occurrence of overdose was reported as an accidental or intentional overdose without adverse effect.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
1309314|NCT02613403|Primary|Number of Participants Who Experienced a Serious and Drug-Related Adverse Event|The number of participants experiencing a serious and drug-related AE was assessed.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
1309315|NCT02613403|Primary|Number of Participants Who Experienced a Drug-Related Adverse Event|The number of participants experiencing a drug-related AE was assessed. A drug-related AE was an AE thought to be possibly, probably, or definitely related to the study drug as determined by the investigator.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
1309316|NCT02613403|Primary|Number of Participants Who Experienced a Serious Adverse Event|The number of participants experiencing a serious adverse event (SAE) was assessed. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
1309317|NCT02613403|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|The number of participants discontinuing study drug due to an AE was assessed.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
1313754|NCT02471612|Secondary|Patients Needing Re-exploration|Number of patients needing return to the operation theater for surgery for the same pathology or any other complication arising out of the initial surgery|30 days||||participants|||Number
1309318|NCT02613403|Primary|Number of Participants Who Experienced an Adverse Event|The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
1309319|NCT02613403|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)|The percentage of participants achieving SVR12 was determined, defined as having a plasma HCV ribonucleic acid (RNA) level below the lower limit of quantification (LLOQ) 12 weeks after the end of study therapy. Plasma HCV RNA level was measured using the Roche COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay with a LLOQ of 15 IU/mL.|12 weeks following final dose of study treatment ([MK-3682B + RBV Groups]: Study Week 28; [MK-3682B Groups]: Study Week 36)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Percentage||95% Confidence Interval|Number
1309320|NCT02612610|Secondary|Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84)|The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE to determine what degree the participant found the taste effect bothersome by answering the question “How bothersome is the taste effect of the medication? The counts and percentages of categorical responses to the individual items were computed for each treatment group.|Day 84|All randomized participants who had taken at least 1 dose of study medication, who had experienced a taste-related AE, and who had Day 84 taste questionnaire data available.|||percentage of participants|||Number
1309321|NCT02612610|Secondary|Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84)|The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE. Participants were asked to indicate the frequency that they experienced the taste effect by answering the question “How frequently do you experience the taste effect after taking each dose of medication?” The counts and percentages of categorical frequency responses to the individual items were computed for each treatment group.|Day 84|All randomized participants who had taken at least 1 dose of study medication, who had experienced a taste-related AE, and who had Day 84 taste questionnaire data available.|||percentage of participants|||Number
1309322|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily|At the end of the treatment period (Day 85), participants were asked “How likely would you be to take this medication?” This question was asked in reference to the time frame of “Twice daily”. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the twice daily question at Day 85.|||percentage of participants|||Number
1309323|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks|At the end of the treatment period (Day 85), participants were asked “How likely would you be to take this medication?” This question was asked in reference to the time frame of “At least four weeks”. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the four week question at Day 85.|||percentage of participants|||Number
1309324|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months|At the end of the treatment period (Day 85), participants were asked “How likely would you be to take this medication?” This question was asked in reference to the time frame of “At least six months”. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the six month question at Day 85.|||percentage of participants|||Number
1309325|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year|At the end of the treatment period (Day 85), participants were asked “How likely would you be to take this medication?” This question was asked in reference to the time frame of “At least one year”. The counts and percentages of ordered categorical responses to this question were computed for each treatment group.|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the one year question at Day 85.|||percentage of participants|||Number
1309326|NCT02612610|Secondary|Percentage of Participants Rated as “Very Much Improved” or “Much Improved” by Clinicians According to the Clinician’s Global Impression of Change (CGIC) at Day 85/Early Termination|"The Clinician’s Global Impression of Change (CGIC) reflects a clinician's belief about the efficacy of treatment. CGIC is a 7-point scale depicting a clinician’s rating of a participant’s overall improvement. Clinicians rated the participant’s change at Week 12 (Day 85) as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.” The counts and percentages of ordered responses to the clinician’s global perception of change were computed for each treatment group, and the percentage of participants rated by clinicians as having improvement (either very much improved or much improved on the CGIC scale) was reported for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 85 CGIC observation during the treatment period.|||percentage of participants|||Number
1313877|NCT02469116|Primary|Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3||Through 30 days after completion of treatment (approximately 22 weeks)||||participants|||Number
1309327|NCT02612610|Secondary|Percentage of Participants Reporting “Very Much Improved” or “Much Improved” According to the PGIC at Day 85/Early Termination|"The self-reported measure Patient’s Global Impression of Change (PGIC) reflects a participant’s belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.” The counts and percentages of ordered responses to the participant’s global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 85 PGIC observation during the treatment period.|||percentage of participants|||Number
1309328|NCT02612610|Secondary|Percentage of Participants Reporting “Very Much Improved” or “Much Improved” According to the PGIC After 8 Weeks of Treatment (Day 56)|"The self-reported measure Patient’s Global Impression of Change (PGIC) reflects a participant’s belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.” The counts and percentages of ordered responses to the participant’s global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group."|Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 56 PGIC observation during the treatment period.|||percentage of participants|||Number
1309329|NCT02612610|Secondary|Percentage of Participants Reporting “Very Much Improved” or “Much Improved” According to the Patient’s Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28)|"The self-reported measure Patient’s Global Impression of Change (PGIC) reflects a participant’s belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.” The counts and percentages of ordered responses to the participant’s global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group."|Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 28 PGIC observation during the treatment period.|||percentage of participants|||Number
1309330|NCT02612610|Secondary|Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination|The LCQ instrument is designed to assess the impact of cough on various aspects of a participant’s life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.|Baseline, Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309331|NCT02612610|Secondary|Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 56)|The LCQ instrument is designed to assess the impact of cough on various aspects of a participant’s life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.|Baseline, Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309332|NCT02612610|Secondary|Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28)|The LCQ instrument is designed to assess the impact of cough on various aspects of a participant’s life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.|Baseline, Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309333|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 12|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 12|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309334|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 11|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 11|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309335|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 10|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 10|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309336|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 9|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 9|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309337|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 8|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 8|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309338|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 7|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 7|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309339|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 6|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 6|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309340|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 5|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 5|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309341|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 4|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 4|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309342|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 3|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 3|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309414|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Number During Gait|Number of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1322037|NCT02253160|Secondary|CD34+ Per kg of Body Weight||within 5 minutes upon completion of procedure||||cells/kg||Standard Deviation|Mean
1309343|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 2|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 2|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309344|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 1|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309345|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 12|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309346|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 11|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309347|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 10|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309348|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 9|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309349|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 8|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309350|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 7|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309523|NCT02607800|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1309351|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 6|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309352|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 5|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309353|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 4|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309354|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 3|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309355|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 2|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309356|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 1|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
1309357|NCT02612610|Secondary|Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309415|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Acceleration During Gait|Acceleration (degrees per second squared) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309524|NCT02607800|Primary|Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1309358|NCT02612610|Secondary|Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309359|NCT02612610|Secondary|Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309360|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 14 (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 98.|Baseline (Study Day -1), Day 98|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 98 endpoint observation during the treatment period.|||percentage of participants|||Number
1309361|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 84.|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 84 endpoint observation during the treatment period.|||percentage of participants|||Number
1309362|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 56.|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 56 endpoint observation during the treatment period.|||percentage of participants|||Number
1309363|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 28.|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 28 endpoint observation during the treatment period.|||percentage of participants|||Number
1309416|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Amplitude During Gait|Distance (degrees) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309570|NCT02605187|Secondary|Count of Participants Who Need Medical Treatment of Pruritus|Count of participants who need medical treatment of pruritus during first 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
1309364|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 98.|Baseline (Study Day -1), Day 98|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 98 endpoint observation during the treatment period.|||percentage of participants|||Number
1309365|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 84.|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 84 endpoint observation during the treatment period.|||percentage of participants|||Number
1309366|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 56.|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 56 endpoint observation during the treatment period.|||percentage of participants|||Number
1309367|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 28.|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 28 endpoint observation during the treatment period.|||percentage of participants|||Number
1309368|NCT02612610|Secondary|Change From Baseline in Cough Severity VAS At Day 85/Early Termination|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Day 85/Early Termination. Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 85|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
1309369|NCT02612610|Secondary|Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84)|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 12 (Day 84). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
1309370|NCT02612610|Secondary|Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56)|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 8 (Day 56). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
1309417|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Velocity During Gait|Velocity (degrees per second) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309371|NCT02612610|Secondary|Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28)|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 4 (Day 28). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
1309372|NCT02612610|Secondary|Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline (Study Day -1), Day 98|All randomized participants who had taken at least 1 dose of study medication and provided baseline and follow-up visit (Day 98) data during the treatment period.|||coughs/hour||Standard Deviation|Mean
1309373|NCT02612610|Secondary|Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309374|NCT02612610|Secondary|Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline (Study Day -1), Day 28,|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309375|NCT02612610|Secondary|Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309376|NCT02612610|Secondary|Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309377|NCT02612610|Secondary|Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309378|NCT02612610|Primary|Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Least-squares (LS) mean change from baseline (in log scale) with associated standard error (SE) reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline Visit (Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline primary endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
1309379|NCT02612077|Secondary|Quality of Life - Global Health Status|Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).|Baseline, 6 and 12 months|Participants in the efficacy analysis set who filled out the questionnaire at inclusion|||units on a scale||Inter-Quartile Range|Median
1309380|NCT02612077|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.|Up to 36 months|Efficacy analysis set receiving bevacizumab at inclusion|||Months||95% Confidence Interval|Median
1309381|NCT02612077|Primary|Progression-free Survival|Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively|within 36 months|Efficacy analysis set receiving bevacizumab at inclusion|||Months||95% Confidence Interval|Median
1309382|NCT02612064|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline, 60 seconds post first treatment, Day 3|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
1309383|NCT02612064|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||score on a scale||Standard Deviation|Mean
1309384|NCT02612064|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 3 days|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
1309385|NCT02611765|Primary|Treatment Success Defined as a Decrease in Rapid Plasma Reagin (RPR) Titer of >= 2 Dilutions (4-fold)|Number of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.|12 months||||participants|||Number
1309386|NCT02611154|Secondary|Testosterone Level in Blood as Measured for Safety|Testosterone level in blood to ensure safety levels of testosterone prior to (Day 0) and after the first two weeks of drug administration (Day 19). Steroid levels below the normal range were considered safe to continue study participation.|Day 0 and Day 19||||ng/mL||Full Range|Mean
1309387|NCT02611154|Secondary|Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline|"Participants were asked to provide 3 urine samples at Day 1, Day 3, Day 5 to measure their baseline urinary steroid marker levels. To accommodate participant schedules, all baseline samples were collected within a two week timeframe. This outcome is measuring if any participants baseline urine samples resulted in a suspicious steroid profile. For this study, suspicious is defined as any urine sample resulting in testosterone steroid detection above 200ng/mL."|Day 1, Day 3, Day 5||||Participants|||Count of Participants
1309418|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Number During Gait|Number of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)|||||||
1309837|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.||Three months.|Bellow concentration data of TC was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
1309388|NCT02611154|Primary|Steroid Levels in Urine Steroid Profile|"Participants were instructed to follow this dosing pattern:~Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28~The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29.~Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose"|4 weeks of dosing for each participant||||ng/mL||Standard Deviation|Mean
1309389|NCT02610816|Secondary|Percent of Participants With Positive and Negative Milk Skin Prick Tests Responding to 1FED|Reactions to skin prick test (SPT) to milk is positive if the wheal size of the milk test is at least 3 mm larger than the wheal size of the negative control. Treatment response is defined as clinical histologic remission (<15 eos/hpf).|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||percentage of participants|||Number
1309390|NCT02610816|Secondary|Change From Baseline in Endoscopic Reference Score at 12 Weeks|The EoE Endoscopic Reference Score (EREFS) measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema and furrows as absent (0) or present (1); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 – 9). Scores were obtained at baseline and 12 weeks. Change in score is defined as the EREFS total score at 12 weeks minus total score at baseline. 1FED vs 4FED changes are compared. A reduction in score (negative change) is indicative of a reduction in esophageal abnormalities.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
1309391|NCT02610816|Secondary|Change From Baseline in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales at 12 Weeks|The PedsQL 4.0 measures physical and psychosocial function. The range for PedsQL 4.0 scores is 0 to 100, with a higher score indicating better quality of life. Scores were obtained at baseline and 12 weeks. Change in score is defined as the PedsQL 4.0 total score at 12 weeks minus total score at baseline. 1FED vs 4FED changes are compared. An increase in score (positive change) is indicative of improved quality of life.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
1309392|NCT02610816|Secondary|Change From Baseline in Pediatric Quality of Life Inventory Version 3.0 EoE Module (PedsQL 3.0 EoE) at 12 Weeks|The PedsQL 3.0 EoE measures symptoms and problems related to treatment, worry, communication, food/eating, and feelings. The range for PedsQL 3.0 EoE scores is 0 to 100, with a higher score indicating better quality of life. Scores were obtained at baseline and 12 weeks. Change in score is defined as the PedsQL 3.0 EoE total score at 12 weeks minus total score at baseline. 1FED vs 4FED changes are compared. An increase in score (positive change) is indicative of improved quality of life.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
1309393|NCT02610816|Secondary|Percent of 1FED Non-responders on 4FED in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2|Percent of 1FED non-responders on 4FED in histologic remission in phase 2. Remission is defined as esophageal peak eosinophil count < 15 eosinophils per high powered field. Complete remission is defined as ≤ 1 peak eos/hpf and partial remission as 2 – 14 peak eos/hpf.|12 weeks|We performed Intent to treat analysis including participants who had at least one clinical observation post randomization.|||percentage of participants|||Number
1309394|NCT02610816|Secondary|Percent of Participants on Swallowed Glucocorticoids (SGC) in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2|Percent of 4FED non-responders on SGC in Phase 2 in histologic remission. Remission is defined as esophageal peak eosinophil count < 15 eosinophils per high power field (eos/hpf). Complete remission is defined as ≤ 1 peak eos/hpf and partial remission as 2 – 14 peak eos/hpf.|12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||percentage of participants|||Number
1309395|NCT02610816|Secondary|Percent of Participants in Histologic Remission (<15 Eosinophils Per High Power Field) at 12 Weeks|Percent of participants in remission in 1FED and 4FED groups. Remission is defined as clinical esophageal peak eosinophil count < 15 eosinophils per high power field (eos/hpf). Complete remission is defined as ≤ 1 peak eos/hpf and partial remission as 2 – 14 peak eos/hpf.|12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization.|||percentage of participants|||Number
1309396|NCT02610816|Primary|Within-group Comparisons (Baseline v. Week 12) of PEESS V2.0 Scores|The PEESS V2.0 questionnaire captures EoE-specific symptoms. The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Baseline vs Week 12 scores are compared within each treatment group (1FED and 4FED).|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
1309419|NCT02610634|Secondary|Gait Parameter: Double Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309420|NCT02610634|Secondary|Gait Parameter: Single Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1314651|NCT02443402|Secondary|Hospital Mortality Rate|The total number of subject deaths during hospital stay will be recorded.|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1309397|NCT02610816|Primary|Change From Baseline in Pediatric EoE Symptom Score Version 2.0 (PEESS V2.0) at 12 Weeks|The PEESS V2.0 questionnaire captures EoE-specific symptoms (dysphagia, gastro-esophageal reflux disease (GERD), nausea/vomiting, and pain) as reported by children with EoE (8-18 years of age) and their parents (for children 2-18 years of age). The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Scores were obtained at baseline and 12 weeks. Change in score is defined as total score at 12 weeks minus total score at baseline. The parent-proxy PEESS total score change from pre-treatment to post-treatment is the primary efficacy endpoint. 1FED vs 4FED changes are compared. A reduction in score (negative change) is indicative of a reduction in symptoms.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization.|||units on a scale||Standard Deviation|Mean
1309398|NCT02610634|Other Pre-specified|Geriatric Depression Scale (GDS-15)|This involves 15 questions about the mood of the subjects. Scores of 0 to 4 to be in the normal range, 5 to 9 to indicate mild depression, and 10 to 15 to indicate moderate to severe depression.|Session 1 (full session lasts approx. 3 hours)|||||||
1309399|NCT02610634|Other Pre-specified|Addenbrookes Cognitive Examination (ACE-R)|The ACE-R involves testing of attention, orientation, memory, fluency, language and visuospatial abilities.|Session 1 (full session lasts approx. 3 hours)|||||||
1309400|NCT02610634|Other Pre-specified|Montreal Cognitive Assessment (MoCA)|Different cognitive domains are assessed (attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation).|Session 1 (full session lasts approx. 3 hours)|||||||
1309401|NCT02610634|Other Pre-specified|Falls Efficacy Scale – International (FES-I)|Fear of falling will be measured using the falls efficacy scale – international version. This is a short and valid measure of fear of falling in older adults, which assesses basic and demanding activities (both physical and social). It consists of 16 scenarios (e.g. cleaning the house) and subjects must rate their fear of falling on a scale from 1 (Not at all concerned) to 4 (Very concerned).|Session 1 (full session lasts approx. 3 hours)|||||||
1309402|NCT02610634|Other Pre-specified|Freezing of Gait (FOG) Questionnaire|This is a 10 item questionnaire intended to classify freezing of gait. The questionnaire has 3 parts; distinction of freezers from non-freezers, Freezing severity, frequency and duration and impact of freezing on daily life.|Session 1 (full session lasts approx. 3 hours)|||||||
1309403|NCT02610634|Other Pre-specified|Hoehn & Yahr (H & Y) Scale|The Hoehn and Yahr rating scale is a widely used clinical rating scale, which defines broad categories of motor function in Parkinson’s disease (PD). All participants’ will be tested who are in H &Y stages I-III.|Session 1 (full session lasts approx. 3 hours)|||||||
1309404|NCT02610634|Other Pre-specified|The Unified Parkinson's Disease Rating Scale (UPDRS)|The Unified Parkinson's Disease Rating Scale will be used to assess motor and non-motor features of PD and disease severity. The UPDRS is scored from a total of 195 points; higher scores reflect worsening disability.|Session 1 (full session lasts approx. 3 hours)|||||||
1309405|NCT02610634|Other Pre-specified|Contrast Sensitivity|CS will be measured using the Mars CS sheets placed on an adjustable holder. The sheet consists of 48 Latin letters of uniform height; the contrast from the white background decreases with subsequent letters. Room illumination is adjusted so that average CS sheet luminance is between 80 and 120cd/m² (measured via a luminance meter). Assessment is done binocularly with the average distance from the patients eyes being 50cm. Participants read aloud down the sheet starting at the top left. Errors are recorded on the pre-set score sheet and testing is terminated after 2 consecutive errors.|Session 1 (full session lasts approx. 3 hours)|||||||
1309406|NCT02610634|Other Pre-specified|Visual Acuity|VA is measured binocularly used a standard LogMAR chart. Participants will be seated at a distance of 4m from the chart. Participants will be instructed to read aloud down the chart starting from the top left.|Session 1 (full session lasts approx. 3 hours)|||||||
1309407|NCT02610634|Other Pre-specified|Visual Object and Space Perception Battery (VOSP)|This study will use a selection of these tests; incomplete letters, dot counting and position discrimination.|Session 1 (full session lasts approx. 3 hours)|||||||
1309408|NCT02610634|Other Pre-specified|Clock Copying (CLOX 1 and 2)|Participants are required to draw a clock with the numbers and arrows pointed at a particular time. Then the subjects have to copy a clock drawn by the researcher.|Session 1 (full session lasts approx. 3 hours)|||||||
1309409|NCT02610634|Other Pre-specified|Benton’s Judgement of Line Orientation (JLO) Test|JLO is a test of visuospatial ability, which involves a subject viewing a set of numbered lines and then being shown two lines of the same orientation. Participants then have to name the numbers that the shown lines correspond to.|Session 1 (full session lasts approx. 3 hours)|||||||
1309410|NCT02610634|Other Pre-specified|CDR Attention Battery (Cognitive Drug Research – CDR, United Biosource Corporation, UK)|The Attention CDR involves a series of computerised tests, which the subjects respond to by pressing one of two buttons. Scores for sub-sections of Simple reaction time, Digit vigilance and Choice reaction time will be obtained.|Session 1 (full session lasts approx. 3 hours)|||||||
1309411|NCT02610634|Secondary|Visual Sampling Parameter: Number of Blinks During Gait|Number of blinks observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)|||||||
1309412|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Duration During Gait|Duration (ms) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309413|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Duration During Gait|Duration (ms) of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309838|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.||Three months.|Below concentration data of FFA was after treatment with oral melatonin 2 weeks.|||umol/L||Standard Deviation|Mean
1309421|NCT02610634|Secondary|Gait Parameter: Step Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)|||||||
1309422|NCT02610634|Secondary|Gait Parameter: Step Length|Measured in meters recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309423|NCT02610634|Secondary|Gait Parameter: Gait Speed|Measured in meters per second observed when walking recorded via Vicon 3D motion capture. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
1309424|NCT02610634|Primary|Visual Sampling Parameter: Saccade Frequency During Gait|Number of fast eye movements made per second observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||Saccade frequency (sacc/sec)||Standard Deviation|Mean
1309425|NCT02609841|Secondary|Incidence of Cardiac Arrhythmias|Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause.|12 days|Patients who received all 6 hemodialysis treatments and wore Body Guardian Device, a non-invasive wearable remote cardiac rhythm monitoring system|||% of patients|||Number
1309426|NCT02609841|Secondary|Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate.|Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate. Hyperkalemia defined as serum potassium (S-K) >5.0 mEq/L.|12 days|Per protocol population|||% of patients|||Number
1309427|NCT02609841|Primary|Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients|Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on <3K dialysate. Hyperkalemia defined as serum potassium (S-K) >5.0 mEq/L.|12 Days|Per Protocol Population: all enrolled subjects who receive 6 dialysis treatments within the 12-day study period|||Percent of participants|||Number
1309428|NCT02609672|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.|Week 1 and Week 13|Due to equipment problems, 2 participants from the Exercise Group were not able to complete the Single Stage Treadmill Walking Test.|||Change in ml/kg/min||Standard Deviation|Mean
1309429|NCT02609672|Secondary|Change in Isometric Knee and Hip Extensor and Flexor Strength|The peak torque developed during knee and hip extension and flexion during a maximum isometric contraction will be measured by use of a Biodex System 2 isokinetic dynamometer. Data will be presented as Nm/kg (torque/body mass).|Week 1 and Week 13||||Change in Nm/kg||Standard Deviation|Mean
1309430|NCT02609672|Secondary|Change in Grip Strength (Relative)|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg/kg (grip force/body mass).|Week 1 and Week 13||||Change in kg/kg||Standard Deviation|Mean
1309431|NCT02609672|Secondary|Change in Grip Strength (Absolute)|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.|Week 1 and Week 13||||Change in kg||Standard Deviation|Mean
1309432|NCT02609672|Secondary|Change in Depression Status|Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
1309433|NCT02609672|Secondary|Change in Arthritis-related Self-efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
1309434|NCT02609672|Secondary|Change in Mobility Performance (Timed Up and Go Test)|Mobility performance will be measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3 metres, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
1309435|NCT02609672|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in number of sit-to-stand cycles||Standard Deviation|Mean
1309436|NCT02609672|Secondary|Change in Mobility Performance (Stair Descent)|Mobility performance will be measured using the Stair Descent Test. For this test, the time taken to descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
1309437|NCT02609672|Secondary|Change in Mobility Performance (Stair Ascent)|Mobility performance will be measured using the Stair Ascent Test. For this test, the time taken to ascend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
1309438|NCT02609672|Secondary|Change in Mobility Performance (40 Metre Walk Test)|Mobility performance will be measured using the 40 Metre Walk Test. This test measures the time taken to complete a fast-paced 40 metre walk. The time taken to walk 40 metres is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
1309439|NCT02609672|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Metres||Standard Deviation|Mean
1309440|NCT02609672|Secondary|Change in Resilience|Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
1309441|NCT02609672|Secondary|Change in Self-reported Knee and Hip Pain|Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
1309442|NCT02609672|Primary|Change in Lower Extremity Function|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
1309443|NCT02609659|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants|||Number
1309444|NCT02609659|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.|Up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants|||Number
1309445|NCT02609659|Primary|Mean Change in Hemoglobin Values From Baseline to End of Treatment|The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.|Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)|All participants who received at least 1 dose of study drug (ITT population) with a hemoglobin value at baseline and at given timepoint.|||g/L||Standard Deviation|Mean
1309446|NCT02609659|Primary|Percentage of Participants With Hemoglobin < 10 g/dL During Treatment|The percentage of participants with hemoglobin <10 g/dL during treatment is provided.|up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population) with at least one post-baseline hemoglobin value through the final treatment value.|||percentage of participants|||Number
1309447|NCT02609659|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after flanking imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1309448|NCT02609633|Secondary|Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire|Percentage of participants with overall treatment satisfaction with the use of Accu-Chek® CONNECT Diabetes Management system according to the questionnaire answered by children/adolescents and parents were reported.|Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1309457|NCT02609633|Secondary|Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6|The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = “Not a Problem” to 5-6 = “Big Problem” (Child version) or 1-2 = “Not a Problem” to 5-6 = “Serious Problem” (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
1309449|NCT02609633|Secondary|Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process|Participants preference the Accu-Chek® CONNECT process compared with previous technology/process assessed by questionnaire including following questions; Q 1: Felt more sure of myself using the system, Q 2: Less worried about low BG than used to be, Q 3: Would rather use the system than what used before, Q 4: Felt safer managing diabetes using system than what used before, Q 5: Friends with diabetes should also use the system. Questionnaire was answered by children/adolescents and parents. Here, in children/adolescents post questionnaire for preference the percentage sum is not equal to 100%, because percentage is based on n=41.|Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analyzed' is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1309450|NCT02609633|Secondary|Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability|Percentage of participants who frequently used Accu-Chek® CONNECT Diabetes Management System (blood sugar meter [BSM], phone application [PA] and web portal [WP]) according to the questionnaire about usability answered by children/adolescents and Parent were reported. Here, in parent post questionnaire for usability the sum of percentages are not equal to 100%, because percentage is based on n=44.|Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1309451|NCT02609633|Secondary|Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6|A measurement was defined as hypoglycemic if the glucose value was below 70 mg/dl or below 60 mg/dl or below 50 mg/dl.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||percentage of hypoglycemic measurements||Standard Deviation|Mean
1309452|NCT02609633|Secondary|Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6|Glycemic variability, expressed as mean of all blood glucose(BG) readings per subject within the interval. BG variability was defined as standard deviation (SD) of all glucose readings over the interval.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure.|||milligrams per deciliter (mg/dl)||Standard Deviation|Mean
1309453|NCT02609633|Secondary|Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range|The percentage of target range measurements was defined as the number of within target range readings in the interval divided by the total number of BG checks in the interval.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.|||percentage of blood glucose measurements||Standard Deviation|Mean
1309454|NCT02609633|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6|Assessment of HbA1c is an indicator of long-term control of diabetes.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||percentage of glycated hemoglobin||Standard Deviation|Mean
1309455|NCT02609633|Secondary|Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6|The BGMC Questionnaire has 8 questions, each question ranges in response values from 1 (“Almost Never”) to 3 (“Almost Always”). The derived total score ranges between 8 and 24, where higher score indicates worsened condition.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
1309456|NCT02609633|Secondary|Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6|The DFCS Questionnaire has 19 questions, each question ranges in response values between 1 (“Almost Never”) and 3 (“Almost Always”). The derived total score (19 questions) ranges between 19 and 57, where higher score indicates worsened condition. This questionnaire was answered by Children/adolescents and Parents.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
1309469|NCT02609113|Secondary|Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks|Ultrasound to assess the anatomy of the median nerve|Baseline and 6 weeks||||mm^2||Standard Deviation|Median
1309470|NCT02609113|Secondary|Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks|Ultrasound to assess the anatomy of the median nerve|Baseline and 6 weeks|The Median Nerve Echogenicity (% hypoechoic) was the same at 89%.|||percentage of hypoechoic|||Number
1316287|NCT02397694|Secondary|The Change From Baseline in log10 HIV-1 RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1309458|NCT02609633|Secondary|Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3|The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = “Not a Problem” to 5-6 = “Big Problem” (Child version) or 1-2 = “Not a Problem” to 5-6 = “Serious Problem” (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.|Baseline, Month 3|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
1309459|NCT02609633|Primary|Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the Problem Areas in Diabetes (PAID) Child and Teen (C&T) Parent Questionnaire Score at Month 6|The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = “Not a Problem” to 5-6 = “Big Problem” (Child version) or 1-2 = “Not a Problem” to 5-6 = “Serious Problem” (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.|Baseline, Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4.|||score on a scale||Standard Deviation|Mean
1309460|NCT02609399|Primary|Mean Karnofsky Performance Scale Score During the 2016-2017 Influenza Season|"The Karnofsky Performance Scale is a tool for assessing subject functional impairment.~Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal – no complaints, no evidence of disease) from enrollment through Day 14 of the 2016-2017 influenza season."|ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)|All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)|||units on a scale||Standard Deviation|Mean
1309461|NCT02609399|Primary|Mean Karnofsky Performance Scale Score During the 2015-2016 Influenza Season|"The Karnofsky Performance Scale is a tool for assessing subject functional impairment.~Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal – no complaints, no evidence of disease) from enrollment through Day 14 of the 2015-2016 influenza season."|ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)|All subjects enrolled and randomized.|||units on a scale||Standard Deviation|Mean
1309462|NCT02609399|Primary|Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire|"Symptom evaluation during the 2016-2017 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms.~Item responses:~Not at all~A little bit~Somewhat~Quite a bit~Very much"|ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)|All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)|||units on a scale||Standard Deviation|Mean
1309463|NCT02609399|Primary|Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire|"Symptom evaluation during the 2015-2016 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms.~Item responses:~Not at all~A little bit~Somewhat~Quite a bit~Very much"|ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)|All subjects enrolled and randomized.|||units on a scale||Standard Deviation|Mean
1309464|NCT02609178|Primary|△DT Value|"Disocclusion time (DT) is defined as the time from maximum intercuspation to complete disocclusion during lateral movement. DT related tooth contacts with muscle activity. Abnormities in DT would result in change of muscle activity, thus facilitate the occurrence of temporomandibular joint disorders.~In the study, the DT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.~△DT was calculated for minimizing individual difference among participants. The equation for △DT was: △DT(FGP/ AVR/ CON)= DT (FGP/ AVR/ CON)-DT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||seconds||Standard Deviation|Mean
1309465|NCT02609178|Secondary|Likert's Scale|"The questionaire was designed to evaluate participants' feeling towards the occlusal interference. It would be given to the subject after immediately try-in the crowns. In the questionaire:~Score 0 = No interference (feel comfortable while biting on the artificial crown) Score 1 = Moderate interference(could feel the artificial crown is higher when biting on the artificial crown, but when firmly clenched, the upper teeth could bite on the lower ones) Score 2 = High interference(the artificial teeth is higher that the upper teeth couldn't bite on all the lower teeth when firmly clenched)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||participants|||Number
1309466|NCT02609178|Secondary|Occlusal Adjusting Time for Crowns|Try-in procedure would be finished by the same clinician. The occlusal adjusting time would be counted using a timer and recorded.|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||minutes||Standard Deviation|Mean
1309467|NCT02609178|Primary|△OT Value|"Occlusion time (OT) is defined as the time from the first contact of occluding teeth to maximum intercuspation. OT is directly related with patients’ occlusal contact pattern; and some have considered it as a capable description of occlusion.~In the study, the OT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.~△OT was calculated for minimizing individual difference among participants. The equation for △OT was:△OT(FGP/ AVR/ CON)= OT (FGP/ AVR/ CON)-OT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||seconds||Standard Deviation|Mean
1309468|NCT02609113|Secondary|Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks|Ultrasound to assess the anatomy of the median nerve|Baseline and 6 weeks||||percentage of Abnormal|||Number
1322377|NCT02246608|Primary|Closure Rate of Non-healing Wounds|Wound dimensions will be measured weekly and monitored for changes|12 weeks||||percentage of healing||Standard Deviation|Mean
1309471|NCT02609113|Primary|Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks|Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.|Baseline and 6 weeks||||units on a scale||Standard Deviation|Median
1309472|NCT02609100|Secondary|Procedure Related Adverse Events|Adverse events related to the video capsule endoscopy and colonoscopy will be recorded|Up to 60 days||||Adverse Events|||Number
1309473|NCT02609100|Secondary|Duration of Hospital Stay|The duration of hospital stay will be recorded in number of days|Up to 60 days||||Days||Full Range|Mean
1309474|NCT02609100|Secondary|Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding|Includes repeat endoscopies or imaging|Up to 60 days||||Participants|||Count of Participants
1309475|NCT02609100|Secondary|Number of Blood Units Transfused|Number of blood units transfused measured in units of packed red blood cells|Up to 60 days||||Units of blood||Full Range|Mean
1309476|NCT02609100|Secondary|Therapeutic Yield of Colonoscopy|Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.|Up to 7 days||||Participants|||Count of Participants
1309477|NCT02609100|Secondary|Therapeutic Yield of Video Capsule Endoscopy|Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.|Up to 7 days||||Participants|||Count of Participants
1309478|NCT02609100|Primary|Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy|Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata|Up to one hour||||Participants|||Count of Participants
1309479|NCT02609100|Primary|Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy|Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata|Up to twenty four hours||||Participants|||Count of Participants
1309480|NCT02608489|Secondary|Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort|Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.|12 weeks|Overall, 1 of 31 patients (3.22%), a 64-year-old man who underwent bilateral sequential same-day cataract surgery, stopped using the study eye drops owing to severe irritation in the D group.|||participants|||Number
1309481|NCT02608489|Secondary|Grades of Anterior Chamber Cells.|"Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.~grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam"|12 weeks||||grade|Participants|Standard Deviation|Mean
1309482|NCT02608489|Primary|Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).~0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)"|12 weeks||||Scores on a scale|Participants|Standard Deviation|Mean
1309483|NCT02608489|Primary|Corneal Fluorescein Staining That is Related to Dry Eye Severity.|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).~0 : best score (no corneal damage) 15 : worst score (severe corneal damages)"|12 weeks||||scores|Participants|Standard Deviation|Mean
1309484|NCT02608489|Primary|Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.|TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.|12 weeks||||seconds|Participants|Standard Deviation|Mean
1309485|NCT02608489|Primary|Changes in HOAs After Blinking That is Related to Dry Eye Severity.|Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.|12 weeks||||microns|Participants|Standard Deviation|Mean
1309486|NCT02608489|Primary|Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.|Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.|12 weeks||||mm|Participants|Standard Deviation|Mean
1309487|NCT02608489|Primary|an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.|The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.|12 weeks||||scores on a scale|Participants|Standard Deviation|Mean
1309488|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 144||Baseline; Week 144|||||||
1309489|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|||||||
1324414|NCT02203630|Other Pre-specified|Mean Central Venous Oxygen Saturation|From chart review (if available)|Up to 28 days|patients with central venous pressure readings|||mm/Hg||Full Range|Mean
1309496|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full analysis Set|||percentage of participants|||Number
1309497|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm||Week 144|||||||
1309498|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm||Week 96|||||||
1309499|NCT02607956|Primary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1309500|NCT02607930|Secondary|Percentage Change From Baseline in Spine BMD at Week 144||Baseline; Week 144|||||||
1309501|NCT02607930|Secondary|Percentage Change From Baseline in Spine BMD at Week 96||Baseline; Week 96|||||||
1309502|NCT02607930|Secondary|Percentage Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1309503|NCT02607930|Secondary|Spine BMD at Baseline||Baseline|The spine DXA Analysis Set: all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing values for baseline spine BMD.|||g/cm2||Standard Deviation|Mean
1309504|NCT02607930|Secondary|Percentage Change From Baseline in Hip BMD at Week 144||Baseline; Week 144|||||||
1309505|NCT02607930|Secondary|Percentage Change From Baseline in Hip BMD at Week 96||Baseline; Week 96|||||||
1309506|NCT02607930|Secondary|Percentage Change From Baseline in Hip BMD at Week 48||Baseline; Week 48|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1309507|NCT02607930|Secondary|Hip Bone Mineral Density (BMD) at Baseline||Baseline|The Hip dual-energy x-ray absorptiometry (DXA) Analysis Set: all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD.|||g/cm2||Standard Deviation|Mean
1309508|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 144||Baseline; Week 144|||||||
1309509|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|||||||
1309510|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||Cell/µL||Standard Deviation|Mean
1309511|NCT02607930|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 144||Baseline; Week 144|||||||
1309512|NCT02607930|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 96||Baseline; Week 96|||||||
1309513|NCT02607930|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1309514|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm||Week 144|||||||
1309515|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm||Week 96|||||||
1309516|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1309517|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm||Week 144|||||||
1309518|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm||Week 96|||||||
1309519|NCT02607930|Primary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1309520|NCT02607800|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1309521|NCT02607800|Secondary|Change From Baseline in HCV RNA||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1309522|NCT02607800|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 1, 2, 4, 8, and 12|Percentage of participants in Full Analysis Set with on-treatment data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1309839|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.||Three months.|Bellow concentration data of Glu was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
1309525|NCT02607800|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the study drug|||percentage of participants||95% Confidence Interval|Number
1309526|NCT02607735|Secondary|Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)|"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit."|Up to Posttreatment Week 24 (Deferred Treatment Substudy)|Full Analysis Set in the Deferred Treatment Substudy|||percentage of participants|||Number
1309527|NCT02607735|Secondary|Change From Baseline in HCV RNA (Deferred Treatment Substudy)||Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)|Participants with available data in the Full Analysis Set of the Deferred Treatment Substudy were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1309528|NCT02607735|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)||Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)|Full Analysis Set from the Deferred Treatment Sub study: all enrolled participants who took at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1309529|NCT02607735|Secondary|Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)|SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1309530|NCT02607735|Secondary|Percentage of Participants With Virologic Failure (Primary Study)|"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.|||percentage of participants|||Number
1309531|NCT02607735|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.|||percentage of participants||95% Confidence Interval|Number
1309532|NCT02607735|Secondary|Change From Baseline in HCV RNA (Primary Study)||Baseline; Weeks 1, 2, 4, 8 and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1309533|NCT02607735|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)||Weeks 1, 2, 4, 8 and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1309534|NCT02607735|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1309535|NCT02607735|Primary|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1309536|NCT02607735|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Participants in the Full Analysis Set (all randomized/enrolled participants who took at least 1 dose of study drug) in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 12 visit.|||percentage of participants||95% Confidence Interval|Number
1309537|NCT02607618|Secondary|Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit|Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.|7 to14 days after the end of treatment||||participants|||Number
1309538|NCT02607618|Primary|Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline|≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).|Baseline and 48 to 72 hours after first dose of study drug||||percentage of participants||95% Confidence Interval|Number
1309539|NCT02606838|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device|Staff obtained responses from persons with Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the Styx Lancing Device. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree' or 'Agree' or 'Neutral' about each statement was calculated.|1 hour||||percentage of participants|||Number
1309540|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|117 (119-2) Subject results were analyzed. Two subject results were not evaluable because staff deviated from protocol by interfering with subjects' operation of the device.|||participants|||Number
1324415|NCT02203630|Other Pre-specified|Mean Metabolic Panel Laboratory Values|From chart review (if available)|Up to 28 days|||||||
1309541|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour||||participants|||Number
1309542|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|118 (119-1) Subject results were analyzed. One subject result was not evaluable because staff deviated from protocol by interfering with subject operation of the device.|||participants|||Number
1309543|NCT02606838|Primary|Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour||||participants|||Number
1309544|NCT02606734|Primary|Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure|The subject is exited from the study once they are discharged.|1 Day||||percent of contrast media saved||Standard Deviation|Mean
1309545|NCT02606279|Secondary|Change From Baseline in Frailty Status|Evaluated by measurements of grip strength, walking speed and questionnaires|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
1309546|NCT02606279|Primary|Change From Baseline in Quantity of AT1R and AT2R on Monocytes|Measured by using qPCR and western blot. (Units are arbitrary units)|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
1309547|NCT02606279|Primary|Change From Baseline in Grip Strength|Measured by dynamometer measurement of grip strength|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
1309548|NCT02606279|Primary|Change From Baseline in 400m Walk|Measured by time to finish 400 meter walk|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
1309549|NCT02605954|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the E/C/F/TAF group with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1309550|NCT02605954|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1309551|NCT02605954|Secondary|Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Only the participants who were randomized to E/C/F/TAF group were analyzed.|||percentage of participants|||Number
1309552|NCT02605954|Secondary|Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 12|Full Analysis Set|||percentage of participants|||Number
1309553|NCT02605954|Primary|Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were randomized and received at least one dose of study drug (either E/C/F/TAF or ABC/3TC+3rd agent on or after Day 1).|||percentage of participants|||Number
1309554|NCT02605928|Primary|True Positive Detection of Synovial Fluid Marked in Case Report Form|Measurement device indicates with a sound and visual feedback when needle is in contact with synovial fluid. Physician verifies the location with ultrasound imaging, aspiration of synovial fluid and/or lack of resistance in glucocorticoid injection. Even if the device does not detect the synovial fluid, physician performs the injection when needed. Physician marks to the case report form whether the device provided detections during the puncture and were the detections true or false detections.|During intra-articular injection||||percentage of injected joints|Injected joints|95% Confidence Interval|Number
1309555|NCT02605863|Primary|Number of Participants With Recurrent Disease|Bladder cystoscopy, urine cytology, and pathology report|1 year||||Participants|||Count of Participants
1309556|NCT02605304|Secondary|CD4+ T-cell (CD4) Count Change From Baseline|Change in CD4 count was calculated as value at the post entry visit minus the value at study entry.|Entry and at 12 (and 24 in Arm B) weeks after study entry|All participants enrolled with CD4 result available at entry and at the post-entry visit.|||cells/mm^3||Inter-Quartile Range|Median
1309557|NCT02605304|Secondary|Number of Participants With HIV-1 RNA >50 Copies/mL|HIV-1 RNA testing was performed at a central laboratory using Abbott RealTime HIV-1 assay (Abbott Laboratories, Lake Bluff, IL, USA).|Entry (Week 0); at 4, 12 (and 24 in Arm B) weeks after study entry, and at 4 weeks after treatment discontinuation|All participants enrolled with HIV-1 RNA results available at the visit.|||Participants|||Count of Participants
1309571|NCT02605187|Secondary|Pruritus Score at 24 and 48 After Delivery|Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching.|24 and 48 hours following delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
1324416|NCT02203630|Other Pre-specified|Mean Central Venous Pressure||Up to 28 days||||mm/Hg||Full Range|Mean
1309558|NCT02605304|Secondary|Number of Participants With Unquantifiable HCV RNA|Unquantifiable HCV was defined as HCV RNA below the LLOQ of the assay (15 IU/mL), either TD or TND. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland).|Entry (Week 0); at 1, 4, 8, 12 (and 16, 20, 24 in Arm B) weeks after study entry|All participants enrolled who had HCV RNA results available at the visit.|||Participants|||Count of Participants
1309559|NCT02605304|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)|SVR24 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 24 weeks after treatment discontinuation. The sample from a visit greater than 20 weeks after treatment discontinuation which was closest to the targeted week (24 weeks post treatment), not followed by any HCV RNA result ≥LLOQ, was used. If there was no HCV RNA sample within this window, then the participant was considered not to have achieved SVR24. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals.|At 24 weeks after treatment discontinuation (i.e., at 36 weeks after study entry in Arm A and at 48 weeks after study entry in Arm B).|All participants enrolled.|||percentage of participants||90% Confidence Interval|Number
1309560|NCT02605304|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks After Treatment Discontinuation (SVR4)|SVR4 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 4 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR4, unless there were preceding and subsequent HCV RNA measurements that were both <LLOQ (either TD or TND). HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals.|At 4 weeks after treatment discontinuation (i.e., at 16 weeks after study entry in Arm A and at 28 weeks after study entry in Arm B).|All participants enrolled.|||percentage of participants||90% Confidence Interval|Number
1309561|NCT02605304|Secondary|Percentage of Participants With Protocol-specified Renal Events|The study protocol defined renal events as (1) ≥Grade 2 creatinine clearance (CRCL) after study entry, or (2) new urinalysis proteinuria and/or glucosuria, defined as ≥1+ or an increase ≥1+ from baseline. The percentage of participants who experienced any renal event, and the percentages of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line.|From study entry to study completion (Week 36 in Arm A, Week 48 in Arm B)|All participants enrolled.|||percentage of participants|||Number
1309562|NCT02605304|Primary|Percentage of Participants With Grade 3 or Higher Adverse Event (AE), Serious AE (SAE), or AE Reported as the Reason for Permanent Discontinuation of Study Treatment|Percentage of participants who experienced an AE (diagnosis, sign/symptom or laboratory abnormality) of ≥Grade 3, SAE according to International Conference on Harmonisation (ICH) criteria, or AE reported as the reason for permanent study treatment discontinuation, during study treatment and up to 30 days after study treatment. Events that were ongoing at the same grade from prior to study treatment initiation were excluded. AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (V2.0) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. The percentage of participants who experienced any event (overall), and the percentage of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line.|From study treatment initiation to 30 days after study treatment discontinuation. Duration of treatment was 12 weeks in Arm A and 24 weeks in Arm B.|All participants enrolled.|||percentage of participants|||Number
1309563|NCT02605304|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)|SVR12 was defined as HCV RNA below the LLOQ of the assay (either target detected [TD] or target not detected [TND]) at 12 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR12, unless there were preceding and subsequent HCV RNA measurements that were both <LLOQ (either TD or TND). HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals.|At 12 weeks after treatment discontinuation (i.e., at 24 weeks after study entry in Arm A and at 36 weeks after study entry in Arm B).|All participants enrolled.|||percentage of participants||90% Confidence Interval|Number
1309564|NCT02605187|Secondary|Patient Overall Satisfaction With Postoperative Analgesia|Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied.|24 and 48 hours after delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
1309565|NCT02605187|Secondary|Time to Discharge|Minutes from delivery until discharge.|Delivery through discharge (average 4 days)|Participants who completed the protocol are included in the analysis.|||minutes||Standard Deviation|Mean
1309566|NCT02605187|Secondary|Average Number of Vomiting Episodes After Delivery||0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||vomiting episodes||Standard Deviation|Mean
1309567|NCT02605187|Secondary|Counts of Participants Who Need Medical Treatment for Nausea|Counts of participants who need medical treatment of nausea through 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
1309568|NCT02605187|Secondary|Nausea Score Score at 24 and 48 After Delivery|Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
1309569|NCT02605187|Secondary|Counts of Participants With Presence of Nausea|Count of participants with nausea through 48 hours after delivery.|0-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
1309574|NCT02605187|Primary|Pain Scores|Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain.|3, 6, 12, 24, 36 and 48 hours after delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
1309575|NCT02605174|Other Pre-specified|Number of Participants With Treatment Emergent Events|Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section|From Baseline Up to End of Study (Up to 11 Weeks)|All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.|||participants|||Number
1309576|NCT02605174|Other Pre-specified|Percentage of Participants With Resource Utilization|Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study|6 Months Prior to Enrolling in Study to End of Study (Up to 11 Weeks) Within 7 Days of Treating a Single Migraine Attack|All randomized participants who had received at least one dose of study drug and had evaluable resource utilization data.|||percentage of participants|||Number
1309577|NCT02605174|Other Pre-specified|Percentage of Participants With Photophobia Free|The percentage of participants without photophobia.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.|||percentage of participants|||Number
1309578|NCT02605174|Other Pre-specified|Percentage of Participants With Phonophobia Free|The percentage of participants without phonophobia.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable phonophobia free data.|||percentage of participants|||Number
1309579|NCT02605174|Other Pre-specified|Percentage of Participants Nausea Free|The percentage of participant without nausea.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable nausea free data.|||percentage of participants|||Number
1309580|NCT02605174|Other Pre-specified|Percentage of Participants Use of Rescue Medication|The percentage of participants who used rescue medication.|From 24 Post Dose Up to 48 Hours|All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.|||percentage of participants|||Number
1309581|NCT02605174|Other Pre-specified|Percentage of Participants Use of Rescue Medication|The percentage of participants who used rescue medication.|From 2 Hours Post Dose Up to 24 Hours|All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.|||percentage of participants|||Number
1309582|NCT02605174|Other Pre-specified|Percentage of Participants Use of Rescue Medication|The percentage of participants who used rescue medication.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.|||percentage of participants|||Number
1309583|NCT02605174|Other Pre-specified|Number of Participants With Headache Recurrence|The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)|From 2 Hours Post Dose Up to 48 Hours|All randomized participants who received at least one dose of study drug and had evaluable headache recurrence data.|||Participants|||Count of Participants
1309584|NCT02605174|Other Pre-specified|Percentage of Participants With Headache Relief|The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable headache relief data.|||percentage of participants|||Number
1309585|NCT02605174|Primary|Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free|The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable MBS data.|||percentage of participants|||Number
1309586|NCT02605174|Primary|Percentage of Participants Headache Pain Free at 2 Hours Post Dose|The percentage of participants defined as mild, moderate, or severe headache pain becoming none.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.|||percentage of participants|||Number
1309587|NCT02604589|Secondary|Surgical Intensive Care Unit (SICU) Length of Stay|Integer days of admission to the surgical intensive care unit. For patients not requiring admission to surgical intensive care, patient is not analyzed. Usual range is 3-5 days.|from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit|Only patients analyzed who had surgical intensive care unit admission.|||days||Standard Deviation|Mean
1309588|NCT02604589|Secondary|Hospital Length of Stay|Integer days of inpatient admission in the hospital stay that included randomization.|from randomization to discharge, usually within the range of 5-15 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one subject to analyze, so standard deviation =0|||days||Standard Deviation|Mean
1309589|NCT02604589|Secondary|Mortality|All cause death, death associated with infusion catheter, within 30 days from date of randomization. This outcome will be scored as yes/no and cause of death will be collected.|30 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group|||Participants|||Count of Participants
1309590|NCT02604589|Secondary|Morbidity|Collection of complications observed at any point during the hospital admission that included randomization, including pneumothorax, hemothorax, acute respiratory distress syndrome, pneumonia, empyema, need for tracheostomy, need for mechanical ventilation, length of time on mechanical ventilation, and an assessment of the degree of association of each event with the catheter insertion procedure or with underlying trauma. Each of these outcomes will be scored as yes/no.|3 days or hospital length of stay, whichever is longer|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group|||number of complications|||Number
1309591|NCT02604589|Secondary|Time to Improvement in Pain Intensity|Determine the impact of catheter-infused medications on self-reported pain intensity reported as a change from baseline (admission) at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group) on a 0-10 point Likert scale, with 0=no pain, and 10= the worst pain ever. Response will be defined as time to a decrease of at least two points on the scale.|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. Only one subject remains to be analyzed in that group so standard deviation = 0|||days||Standard Deviation|Mean
1309592|NCT02604589|Secondary|Time to Improvement in Pulmonary Function|Determine the impact of catheter-infused medications on maximal inspiratory lung volume measured by incentive spirometer (IS) as a change from baseline at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group). Endpoint will be the time to improvement of vital capacity to greater than 1.4 liters (or 15 mL/kg).|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one member to analyze; therefore standard deviation = 0.|||days||Standard Deviation|Mean
1309593|NCT02604589|Primary|Narcotic Use|Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group|||mg/24 hours over days 1-3||Standard Deviation|Mean
1309594|NCT02604550|Secondary|"Percent of Patients Rating Their Satisfaction as Excellent or Good"|Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.|2 Weeks Post-Surgery|This analysis includes participants who completed the study and used a smartphone application to record study outcome measures following surgery.|||percentage of participants|||Number
1309595|NCT02604550|Secondary|Time to Straight Less Raise|The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application to record when they were able to perform a straight leg raise following surgery.|||hours||Standard Deviation|Mean
1309596|NCT02604550|Secondary|Patient-Reported Itching|Total occurrences of patient-reported itching post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced itching.|||occurrence of itching|||Number
1309597|NCT02604550|Secondary|Patient-Reported Sedation|Total occurrences of patient-reported feelings of sedation post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced feelings of sedation.|||occurrence of sedation|||Number
1309598|NCT02604550|Secondary|Patient-Reported Constipation|Total occurrences of patient-reported constipation post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants completing the study and who used a smartphone application for 6 days post-operatively to record every time they experienced constipation.|||occurrence of constipation|||Number
1309599|NCT02604550|Secondary|Patient-Reported Vomiting|Total occurrences of patient-reported vomiting post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced vomiting.|||occurrence of vomiting|||Number
1309600|NCT02604550|Secondary|Patient-Reported Nausea|Total occurrences of patient-reported nausea post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants completing the study who used a smartphone application for 6 days post-operatively to record every time they experienced nausea.|||occurrence of nausea|||Number
1309601|NCT02604550|Secondary|Total Hours of Sleep|The total hours of sleep first postoperative night, between 0 to 12 hours.|First Postoperative Night (up to 12 hours)|This analysis includes participants who completed the study and used a smartphone application to record their number of hours of sleep during the night following their surgery.|||hours||Standard Deviation|Mean
1309602|NCT02604550|Secondary|Number of Percocet Tablets Consumed|Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,|Post surgery, Day 0 to Day 6|This analysis includes participants who completed the study and used a smartphone application to record the number of Percocet tablets taken for 6 days post-surgery.|||count of tablets||Standard Deviation|Mean
1309603|NCT02604550|Primary|Pain Score|Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.|Post-surgery (day of surgery to 6 days post-surgery)|This analysis includes participants who completed the study and used a smartphone application to record pain level for 6 days post-surgery.|||units on a scale||Standard Deviation|Mean
1309604|NCT02604407|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)|CGI scales permit a global evaluation of the participant’s severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Visit 6 (Week 4)|Full-analysis set (FAS) consisted of all participants in the safety set who had at least 1 postdose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment with number of participants evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
1309605|NCT02604407|Primary|Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)|The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.|Baseline, Visit 6 (Week 4)|Full Analysis Set (FAS) consisted of all participants in the safety set who had at least 1 post dose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment.|||Units on a scale||Standard Deviation|Mean
1309840|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.||Three months|Bellow concentration data of Fbg was after treatment with oral melatonin 2 weeks.|||g/L||Standard Deviation|Mean
1309606|NCT02604342|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 15 months|Safety (SAF) population included all participants who received at least one dose of any study drug.|||Percentage of Participants|||Number
1309607|NCT02604342|Secondary|TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for ITT Population|TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms [cough, dyspnea [multi-item subscales QLQ-LC13] and chest pain]) as measured by the EORTC QLQ-LC13.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
1309608|NCT02604342|Secondary|TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for C-ITT Population|TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms [cough, dyspnea [multi-item subscales QLQ-LC13] and chest pain]) as measured by the EORTC QLQ-LC13.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
1309609|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC30 Score for C-ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
1309610|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC30 Score for ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
1309611|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC13 Score for C-ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment). Number analyzed indicates number of participants evaluated for specified categories.|||months||95% Confidence Interval|Median
1309612|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC13 Score for ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified categories.|||months||95% Confidence Interval|Median
1309613|NCT02604342|Secondary|Compliance of European Quality of Life (EuroQoL) 5 Dimension 5 Levels (EQ-5D-5L) Questionnaire Over Time|Percentage of participants who filled out an ED-5D-5L questionnaire at a visit. EQ-5D-5L: A generic preference-based health utility measure that provides a single index value for health status. The instrument consists of two parts. The first part, health-state classification, contains five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
1309614|NCT02604342|Secondary|Compliance of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) Over Time|Percentage of participants who filled out an EORTC QLQ-LC13 questionnaire at a visit. The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
1309637|NCT02604017|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of particpants||95% Confidence Interval|Number
1324417|NCT02203630|Other Pre-specified|Mean Blood Pressure (Maximum and Minimum)||Up to 28 days||||mm/Hg||Full Range|Mean
1309615|NCT02604342|Secondary|Compliance of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Over Time|Percentage of participants who filled out an EORTC QLQ-C30 questionnaire at a visit. The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden.|Approximately 15 months (baseline, Weeks 3, 6, 12 and every 6 weeks until PD, death, or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
1309616|NCT02604342|Secondary|Plasma Concentration of Alectinib Metabolite||Predose (2 hours) at Baseline, Week 3 and Week 6|The PK Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1309617|NCT02604342|Secondary|Plasma Concentration of Alectinib||Predose (2 hours) at Baseline, Week 3 and Week 6|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1309618|NCT02604342|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from randomization to death from any cause. OS was confounded by cross-over of participants to the alectinib arm.|Approximately 15 months (Baseline until death)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
1309619|NCT02604342|Secondary|Duration of Response for Lesions in the CNS (C-DOR) Using RECIST Version 1.1 as Assessed by IRC|DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. C-DOR was defined in a similar way for lesions in the CNS, taking into account all lesions in the body. DOR was evaluated for participants who had a BOR of CR or PR.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment). Number analyzed indicates number of participants with a BOR of CR or PR.|||months||95% Confidence Interval|Median
1309620|NCT02604342|Secondary|Percentage of Participants With ORR in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC|ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||percentage of participants|||Number
1309621|NCT02604342|Secondary|Percentage of Participants With Disease Control in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC|Disease Control Rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||percentage of participants|||Number
1309622|NCT02604342|Secondary|Time to CNS Progression in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC|Time to CNS progression was defined as the time from randomization until radiographic evidence of CNS progression. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
1309623|NCT02604342|Secondary|PFS in C-ITT Population Using RECIST Version 1.1 as Assessed by Investigator and IRC|PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|Intent-to-treat population with CNS metastasis (C-ITT) included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
1309624|NCT02604342|Secondary|Duration of Response (DOR) Using RECIST Version 1.1 as Assessed by Investigator and IRC|DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until PD, death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.|||months||95% Confidence Interval|Median
1309638|NCT02604017|Secondary|Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1309625|NCT02604342|Secondary|Percentage of Participants With Disease Control Using RECIST Version 1.1 as Assessed by Investigator and IRC|Disease control rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
1309626|NCT02604342|Secondary|Percentage of Participants With Objective Response of CR or PR Using RECIST Version 1.1 as Assessed by Investigator and IRC|ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
1309627|NCT02604342|Secondary|PFS Using RECIST Version 1.1 as Assessed by IRC|PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
1309628|NCT02604342|Secondary|Percentage of Participants With CNS Objective Response Rate (ORR) With Measurable CNS Metastases at Baseline Using RECIST Version 1.1 as Assessed By IRC|Overall response rate in subjects with confirmed CNS response (C-ORR) was defined as the percentage of subjects who attained Complete Response (CR) or Partial Response (PR) for lesions in the CNS. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population with measurable CNS metastasis (mc-ITT) included all participants in ITT population with measurable CNS metastasis at baseline (as per IRC).|||percentage of participants|||Number
1309629|NCT02604342|Primary|Progression-Free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator|PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
1309630|NCT02604264|Primary|The Number of Positive Blood Cultures (PBCs) Per 100 Patient-months||Up to 12 months||||PBC per 100-patient months||95% Confidence Interval|Mean
1309631|NCT02604173|Secondary|Oxygen Saturation|measurement of oxygen saturation (%) by finger tip pulse oximeter.|24 hours||||percent saturation||Standard Deviation|Mean
1309632|NCT02604173|Secondary|Number of Participants With Severe Acute Mountain Sickness|Number of participants with severe acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ) (score > 5).|24 hours||||Participants|||Count of Participants
1309633|NCT02604173|Primary|Number of Participants With Acute Mountain Sickness|Number of participants with acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ)|24 hours||||Count of participants|||Number
1309634|NCT02604017|Secondary|Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants|Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve, received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1309635|NCT02604017|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1309636|NCT02604017|Secondary|Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants|On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve.|||percentage of participants||95% Confidence Interval|Number
1324418|NCT02203630|Secondary|Amount of Time Non-study Vasopressors Used||Up to 28 days|participants receiving non-study vasopressors|||hours|||Number
1309639|NCT02604017|Secondary|Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were co-infected HCV GT1/HIV-1; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1309640|NCT02604017|Secondary|Percentage of Participants With SVR12|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1309641|NCT02604017|Secondary|Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1309642|NCT02604017|Primary|Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.|12 weeks after the last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1309643|NCT02604017|Primary|Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.|12 weeks after last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1 DAA-naïve (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1309644|NCT02604017|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).|12 weeks after the last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
1309645|NCT02603952|Secondary|Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations|Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant’s corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed.|From Baseline (Day 1) to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the LLOQ were analyzed.|||Percentage of Participants|||Number
1309646|NCT02603952|Secondary|Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay|Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose [TCID50]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.|From Baseline (Day 1) to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with quantifiable Influenza A (greater than LLOQ) and a unique hemagglutinin gene sequence were analyzed.|||Participants|||Count of Participants
1309647|NCT02603952|Secondary|Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site|Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant’s corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.|From Baseline (Day 1) to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the lower limit of quantification (LLOQ) were analyzed.|||Percentage of Participants|||Number
1309684|NCT02601560|Secondary|Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57|The change from baseline in serum concentration of lecithin-cholesterol acyltransferase was estimated.|Baseline (Day 1) and Day 57|Pharmacokinetic (PK) population: All participants in the as-treated population who had atleast one detectable LCAT serum concentration measurement.|||mcg/mL||Standard Deviation|Mean
1309648|NCT02603952|Secondary|Number of Days of Influenza Viral Shedding as Measured by qRT-PCR|Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.|From Baseline (Day 1) to Day 7; and Day 9 to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with shedding data available for Day 1 to Day 7 and Day 9 to Day 13 were analyzed for this outcome measure.|||Days||Standard Deviation|Mean
1309649|NCT02603952|Secondary|Quantitation of Influenza Viral Shedding as Measured by qRT-PCR|qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.|Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13|PP population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population.|||Log10 (viral copies/mL)||Standard Deviation|Mean
1309650|NCT02603952|Secondary|Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)|Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported.|Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13|Per-protocol (PP) population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population.|||Percentage of Participants||95% Confidence Interval|Number
1309651|NCT02603952|Primary|Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)|An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.|Day 1 (post-dose) through Day 101|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
1309652|NCT02603952|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)|A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (post-dose) through Day 101|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
1309653|NCT02603952|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (post-dose) through Day 28|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
1309654|NCT02603952|Primary|Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13|Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).|Day 10 through Day 13|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
1309655|NCT02603952|Primary|Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10|Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).|Day 1 (post-dose) through Day 10|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
1309656|NCT02603666|Primary|Elastographic Value in kPa Measured by Fibroscan|Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.|Within 28 days in connection with their annual evaluation at a single point of time||||kPa||95% Confidence Interval|Mean
1309657|NCT02603120|Secondary|Percentage Change From Baseline in Hip BMD at Week 48||Baseline; Week 48|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1309658|NCT02603120|Secondary|Hip Bone Mineral Density at Baseline||Baseline|Hip DXA Analysis Set: participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.|||g/cm^2||Standard Deviation|Mean
1309659|NCT02603120|Secondary|Percentage Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1309660|NCT02603120|Secondary|Spine Bone Mineral Density (BMD) at Baseline||Baseline|Spine dual X-ray absorptiometry (DXA) Analysis Set: participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.|||g/cm^2||Standard Deviation|Mean
1309661|NCT02603120|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1309662|NCT02603120|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1324419|NCT02203630|Secondary|Number of Participants Receiving Non-study Vasopressors||Up to 28 days||||Participants|||Count of Participants
1309663|NCT02603120|Primary|Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1309664|NCT02603107|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
1309665|NCT02603107|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1309666|NCT02603107|Primary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1309667|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with a radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3.5(±0.5)-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. Initial relative crest iRC will be determined as described above from the initial CBCT. In the second CBCT, vertical distance from the iRC from initial CBCT will be used to recreate the iRC. New relative crest will be determined for each of the three planes (nRC) as above. The difference between iRC and nRC indicates change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.|3-4 months|Change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.|||millimeters||Standard Deviation|Mean
1309668|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. The initial relative crest (iRC) reference point will be determined. The buccal and lingual crests at the central plane of site will be marked and distances from this crest to RRP will be measured in mm. The average distance of the buccal crest height and the lingual crest height will be calculated and that value will be used to determine the iRC for that site. Initial Bucco-lingual (iRBL) measurements will be recorded at 1 mm, 3 mm and 7 mm from iRC in all five planes. The final bucco-lingual (fRBL) measurements will be recorded on the second CBCT, using the same method as described before and using the iRC reference. Differences between iRBL and the fRBL reflect change in horizontal ridge width (RΔHD).|3-4 months|Change in horizontal ridge width (RΔHD).|||millimeters||Standard Deviation|Mean
1309669|NCT02602223|Primary|Post Operative Pain|A visual Analog score (VAS) pain scale form (scale of 1 to 10) will be provided with instructions to record pain levels on both surgical sites every day for 2-weeks post-surgery. VAS score of 10 indicates highest level of pain and 0 indicates no pain. Subjects will also asked to log any pain medications taken in that 2-week period. Subjects will be seen at 1&2 weeks for post-operative evaluation and VAS forms will be collected. Data will be reported as Average VAS score.|0-2 weeks|VAS score at 24 hours post operative|||Units on a scale of 10||Standard Deviation|Mean
1309670|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3.5(±0.5)-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. Cores will be process and embedded in polymethylmethacrylate and sectioned to 5μm thickness and sections will be stained with Goldener’s Trichrome. With the Goldener’s trichrome, mineralized bone appears as green or blue regions, osteoid appears orange–red, nuclei appears blue-grey and graft remnants appear grey. Additional differentiation between graft and new bone will be achieved by morphologically assessing each sample individually. A slide scanner will be used to image the sample (20x magnification), and a software program will be used for the histomorphometric analysis, to quantify the amount of total mineralized bone, new bone / osteoid, soft tissue, and residual graft remnants in percentages .|3-4 months|New bone/osteoid Percentages|||Percentage of New bone||Standard Deviation|Mean
1309671|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. A high-resolution microtomographic scanner will be used and images will be scanned at a voxel size of 8µm3. Moist bone cores will be wrapped in paraffin and scanned in air. Cores will be rotated in 0.7 degree increments with 450milli second time exposition. A 0.5m aluminum filter will be used to remove image noise. After scanning, 3D microstructural image data will be reconstructed using software. Structural indices will be calculated using a software. The micro-architectural variables; bone volume density (BV/TV), and bone surface density (BS/BV); will be quantified and reported as percentages.|3-4 month|The micro-architectural variable; bone volume density (BV/TV),was quantified and is reported as percentages.|||Percentage of BV/TV||Standard Deviation|Mean
1324420|NCT02203630|Secondary|Creatinine Kinase (CK)|From chart review (if available)|Up to 28 days|patients with CK levels|||units/L||Full Range|Mean
1309672|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures|A radiographic stent will be fabricated with reproducible access holes ≈5 mm apical to the mid-facial and mid-lingual gingival margin of the teeth to be extracted. On day of surgery, a calibrated examiner masked to treatment allocation, will record initial clinical bucco-lingual (iCBL) ridge measurements in millimeters (mm), through the access holes in the stent, using calipers. Approximately 3.5(±0.5)-months post extractions, the calibrated examiner masked to treatment allocation, will record the final clinical bucco-lingual (fCBL) ridge measurements in mm using the calipers as described earlier. The difference between fCBL and iCBL will be calculated as change in clinical horizontal ridge width dimensions in mm (cΔHD).|3-4 months|change in clinical horizontal ridge width dimensions in mm - cΔHD|||millimeters|Participants|Standard Deviation|Mean
1309673|NCT02601573|Secondary|Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)|The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|Up to Week 40|All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR24 data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1309674|NCT02601573|Primary|Percentage of Participants Discontinuing From Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|All participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
1309675|NCT02601573|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks (up to 2 weeks after completion of study treatment)|All participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
1309676|NCT02601573|Primary|Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)|The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid [RNA] < Lower Limit of Quantification [LLOQ] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|Up to Week 28|All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR12 data available are included.|||Percentage of Participants||95% Confidence Interval|Number
1309677|NCT02601560|Secondary|Number of Participants With Positive Anti-Drug Antibodies for MEDI6012|Participants were tested for immunogenicity to MEDI6012. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of MEDI6012 to its target.|Day 1 (pre-dose), 15, 29 and 57|Immunogenicity population: All participants in the as-treated population with at least one serum sample available for immunogenicity testing.|||Participants|||Count of Participants
1309678|NCT02601560|Secondary|Elimination Half Life (t1/2) of MEDI6012|The t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||hrs||Standard Deviation|Mean
1309679|NCT02601560|Secondary|Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012|The area under the concentration-time curve to infinite time of MEDI6012.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||mcg*hr/mL||Standard Deviation|Mean
1309680|NCT02601560|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012|Area under the plasma concentration time-curve from zero to the last measured concentration (AUC [0-last]) of MEDI6012.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||mcg*hr/mL||Standard Deviation|Mean
1309681|NCT02601560|Secondary|Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012|The area under the concentration-time curve from 0 to 168 hrs of MEDI6012.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||mcg*hr/mL||Standard Deviation|Mean
1309682|NCT02601560|Secondary|Time to Reach Concentration Maximum (Tmax) of MEDI6012|The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||hrs||Full Range|Median
1309683|NCT02601560|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI6012|The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
1309685|NCT02601560|Secondary|Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29|The change from baseline in serum concentration of pre beta 1-high density lipoprotein was estimated.|Baseline (Day 1) and Day 29|As-treated population.|||mg/dL||Standard Deviation|Mean
1309686|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of apolipoprotein B.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309687|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of low density lipoprotein cholesterol (direct).|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309688|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein unesterified cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309689|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesteryl ester.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309690|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein unesterified cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309691|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol|The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309692|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein cholesteryl ester.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309693|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester|The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of cholesteryl ester.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309694|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of free cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309695|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of total cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
1309696|NCT02601560|Primary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated Population.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1309697|NCT02601560|Primary|Number of Participants With TEAEs Related to Clinical Laboratory Evaluations|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|Baseline (Day 1) up to Day 57|As-treated Population|||Participants|||Count of Participants
1309698|NCT02601560|Primary|Number of Participants With TEAEs Related to Vital Sign Parameters|TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.|Baseline (Day 1) up to Day 57|As-treated Population|||Participants|||Count of Participants
1309699|NCT02601560|Primary|Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations|TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to Day 57|As-treated Population|||Participants|||Count of Participants
1324421|NCT02203630|Secondary|CK-MB|From chart review (if available)|Up to 28 days|patients with CK-MB levels|||ng/mL||Full Range|Mean
1309700|NCT02601560|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to Day 57|As-treated Population: All participants who received any amount of study drug were included in this population.|||Participants|||Count of Participants
1309701|NCT02600871|Secondary|Rate of New Lesion Development|New lesions, defined as a new abscess, pustule, carbuncle, or furuncle at least 5cm away from the initial wound, that developed in the subject within 30 days of enrollment|30 Days||||Participants|||Count of Participants
1309702|NCT02600871|Secondary|Infection Rates of Household Contacts|New lesions (abscess, pustule, carbuncle, or furuncle) that developed in household contacts of subjects within 30 days of enrollment|30 Days||||Participants|||Count of Participants
1309703|NCT02600871|Primary|Number of Participants With a Clinical Cure|Clinical cure was defined as improvement in the initial wound with respect to a decrease in measured size, erythema, and purulent discharge. Wound management at the follow up visits was left up to the discretion of the treating provider, but additional interventions for patients not clinically improving or worsening were considered a lack of clinical cure.|7-10 Days||||Participants|||Count of Participants
1309704|NCT02600845|Secondary|Percentage of Blood Glucose Tagged Data|Tagged data specifies the timing of blood glucose recording and includes: fasting, before breakfast, after breakfast, before lunch, after lunch, before dinner, after dinner, and bedtime. The percentage of blood glucose tagged data per interval was calculated as the total number of tagged blood glucose readings during the interval divided by the total number of readings within the interval.|Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percentage||Standard Deviation|Mean
1309705|NCT02600845|Secondary|Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24|An increase in SMBG frequency indicates more glycemic control. The average number of daily SMBG measurements per interval was calculated based on the total number of blood glucose readings recorded during the study visit interval.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||glucose checks per day||Standard Deviation|Mean
1309706|NCT02600845|Secondary|Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24|An increase in the number of blood glucose checks indicates more glycemic control.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||blood glucose checks||Standard Deviation|Mean
1309707|NCT02600845|Secondary|Percent of Follow-Up Visits With Sufficient SMBG Data|Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments.|Up to Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percentage of follow-up visits||Standard Deviation|Mean
1309708|NCT02600845|Secondary|Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24|Competency was defined as appropriate response to high and low glucose values.|Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||Participants|||Count of Participants
1309709|NCT02600845|Secondary|Incidence of Hypoglycemia|A hypoglycemic reading was defined as a glucose value that fell below the 70 mg/dL level. The incidence of hypoglycemia was defined as the number of hypoglycemic readings in the interval divided by the total number of blood glucose checks in the interval.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||hypoglycemic readings||Standard Deviation|Mean
1309710|NCT02600845|Secondary|Change From Baseline to Week 24 in Glycemic Variability|Glycemic variability refers to swings in blood glucose levels. Mean glycemic variability is expressed as a standard deviation of blood glucose data. A negative number indicates a decrease in glucose variability. A positive number indicates and increase in glucose variability.|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1309711|NCT02600845|Secondary|Change From Baseline to Week 24 in Mean Blood Glucose Level|Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes.|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||milligrams per deciliter||Standard Deviation|Mean
1309726|NCT02600351|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA <LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Full Analysis Set by Actual Treatment|||percentage of participants|||Number
1324422|NCT02203630|Secondary|Mean Troponin-I|From chart review (if available)|Up to 28 days|patients with troponin levels|||ng/mL||Full Range|Mean
1309712|NCT02600845|Secondary|Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range|Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL).|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percent||Standard Deviation|Mean
1309713|NCT02600845|Secondary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24|Assessment of HbA1c is an indicator of long-term control of diabetes.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percent||Standard Deviation|Mean
1309714|NCT02600845|Secondary|Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score|Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||score on a scale||95% Confidence Interval|Mean
1309715|NCT02600845|Primary|Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24|The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3=‘much worse now’ to 3=‘much better now’). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only.|Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24.|||score on a scale||95% Confidence Interval|Mean
1309716|NCT02600767|Primary|Absence of Malaria Parasites in Blood.|Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.|28 days||||Participants|||Count of Participants
1309717|NCT02600611|Secondary|Resolution or Near Resolution of Lesion at Test of Cure Visit|Resolution or near resolution of lesion at Test of Cure (TOC) visit|7 to14 days after the end of treatment|all randomized patients (ITT population)|||participants|||Number
1309718|NCT02600611|Primary|≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.|≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).|Baseline and 48-72 hours after first dose of study drug|all randomized patients (ITT).|||percentage of participants|||Number
1309719|NCT02600403|Primary|Visual Field|Visual field pattern standard deviation in decibels (dB). Visual field results compare visual field loss to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. With a localized defect in the visual field, pattern standard deviation (PSD) quantifies amount of loss and progression of glaucoma when in the beginning stages of the disease.|12 months||||dB||Standard Deviation|Mean
1309720|NCT02600403|Primary|Visual Evoked Potential Latency|VEP latency at high contrast as measured in milliseconds (ms). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. VEP latencies measure the duration in time of the energy generated (duration of the signal) from the eye's response to a visual stimulus during the VEP.|12 months||||Milli-seconds (ms)||Standard Deviation|Mean
1309721|NCT02600403|Primary|Visual Evoked Potential Amplitudes|VEP amplitudes at high contrast as measured in microvolts (μV). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. The amplitude measurement is the peak of the energy generated (strongest strength of the signal) from the eye's response to the visual stimulus during the VEP.|12 months||||micro volts (uV)||Standard Deviation|Mean
1309722|NCT02600403|Primary|Average Cup to Disc Ratio|Cup to disc ratio is used to evaluate structural changes comparing the size of the cup to the size of the disc during dilated ophthalmic examination. High eye pressure can cause the cup to enlarge, closer to the size of the disc. This measurement is used to follow progression in glaucoma. A normal range for cup to disc ratio would be 0.0 to 0.4. Advanced glaucoma would be 0.8 to 0.9 cup to disc ratio.|12 months||||ratio||Standard Deviation|Mean
1309723|NCT02600403|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Measurement|Retinal nerve fiber layer (RNFL) thickness in different quadrants of optic nerve and macula are measured pre and postoperatively to evaluate structural changes.|12 months||||um||Standard Deviation|Mean
1309724|NCT02600403|Primary|Visual Field Mean Deviation|Visual field mean deviation as measured in decibels (dB) is the amount of visual field loss compared to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. Brighter light has lower number in decibels. The dimmer the light, the higher the number in decibels with a range of 0 to 40 dB.|12 months||||dB (decibels)||Standard Deviation|Mean
1309725|NCT02600351|Secondary|Number of Participants With Emerging Resistance|The full-length NS3, NS5A, and NS5B coding regions were deep sequenced at pretreatment (baseline) for all participants included in the Full Analysis Set, and at posttreatment for all participants who relapsed.|Up to Posttreatment Week 24|Full Analysis Set by Actual Treatment who have pre-existing NS5B, NS5A, and NS3/4A resistance-associated variants (RAVs) at baseline and who experienced virologic failure were analyzed. There were no participants with pre-existing RAVs who experienced virologic failure in the LDV/SOF+RBV 12 weeks, without cirrhosis group.|||Participants|||Count of Participants
1324423|NCT02203630|Secondary|Cause of Death||Up to 28 days||||Participants|||Count of Participants
1309728|NCT02600351|Secondary|Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set by Actual Treatment|||percentage of participants||95% Confidence Interval|Number
1309729|NCT02600351|Primary|Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1309730|NCT02600351|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set by Actual Treatment: participants were grouped according to their cirrhotic status and the treatment/duration they actually received.|||percentage of participants||95% Confidence Interval|Number
1309731|NCT02599129|Secondary|Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above|Number of subjects achieving a DLQI (Dermatology Life Quality Index), patient global assessment score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).|Week 24||||Participants|||Count of Participants
1309732|NCT02599129|Secondary|Number of Subjects Acheiving Physician’s Global Assessment (PGA) Score of 3 or Above|Number of subjects achieving a Physician’s Global Assessment (PGA) score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).|Week 24||||Participants|||Count of Participants
1309733|NCT02599129|Secondary|Number of Subjects Achieving a SALT Score of 90 at Week 28|Number of subjects achieving a SALT score of 90|week 28||||Participants|||Count of Participants
1309734|NCT02599129|Secondary|Number of Subjects Achieving a SALT Score of 90 at Week 24|Number of subjects achieving a SALT score of 90 at week 24|week 24||||Participants|||Count of Participants
1309735|NCT02599129|Primary|Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50|Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24|Week 24||||Participants|||Count of Participants
1309736|NCT02598934|Secondary|"Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6"|The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from ‘Not At All Confident’ to ‘Very Confident.’ A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.|Month 6|ITT population|||percentage of participants|||Number
1309737|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)|Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1309738|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1309739|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)|Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1309740|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)|Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1309741|NCT02598934|Primary|Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)|Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1309742|NCT02598622|Primary|Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.||Days 1 - 21|Only 2 out of 8 participants were able to complete protocol related therapy and therefore no data were collected for analysis.||||||
1309743|NCT02598583|Secondary|Change in Clinical Manifestations of PNH|Clinical manifestations are fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction. Improvement defined as present at baseline and absent at Day 169. Worsening defined as absent at baseline and present at Day 169.|Baseline to Day 169||||Participants|||Count of Participants
1309744|NCT02598583|Secondary|Change in D-dimer||Baseline to Day 169||||ug/L||Standard Deviation|Mean
1309745|NCT02598583|Secondary|Change in PNH Red Blood Cell (RBC) Clones||Baseline to Day 169||||Percentage||Standard Deviation|Mean
1309746|NCT02598583|Secondary|Change From Baseline in Reticulocyte Count||Baseline to Day 169||||percentage||Standard Deviation|Mean
1309750|NCT02598193|Secondary|Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments||Baseline up to Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Number of Days||Standard Deviation|Mean
1309751|NCT02598193|Secondary|Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib||Baseline up to Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Participant Days|||Number
1309752|NCT02598193|Secondary|Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit||Baseline up to Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Percentage of Praticipants||95% Confidence Interval|Number
1309753|NCT02598193|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to Week 28|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Percentage of Participants|||Number
1309754|NCT02598193|Primary|Percentage of Participants Who Complete 24 Weeks of Combination Treatment on Pirfenidone at a Dose of 1602-2403 mg/Day and Nintedanib at a Dose of 200-300 mg/Day||Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Percentage of Participants||95% Confidence Interval|Number
1309755|NCT02598128|Other Pre-specified|Ease of Use of RELiZORB (Per-Protocol Population)|Effect of enteral nutrition on select activities of daily living. Patients judged the size of breakfast after overnight enteral tube feeding with the following choices: No breakfast; Small breakfast; Normal breakfast; Big breakfast; Other.|Period C: Single assessment on Day 19 or 20|Per Protocol Population.|||Participants|||Count of Participants
1309756|NCT02598128|Primary|Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)|AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours|Day 1 first intervention and Day 9 second intervention.||||ug*h/mL||Standard Deviation|Mean
1309757|NCT02598128|Primary|Number of Patients With Adverse Events and Unanticipated Adverse Device Effects|1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)|27 days|Safety Population|||Participants|||Count of Participants
1309758|NCT02597907|Primary|The Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea and vomiting during 24 hours postoperatively|24 hours||||Participants|||Count of Participants
1309759|NCT02597855|Secondary|Best Corrected Visual Acuity|Best corrected visual acuity assessed at baseline, 3 months, and 6 months|baseline, 3 months, and 6 monthsc|Participants who were finished 6 months follow up period.|||LogMAR||Standard Deviation|Mean
1309760|NCT02597855|Primary|Regression Rate of Polyp on Indocyanine Green Angiography|Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%.|3 months|Participants who were finished 6 months follow up period.|||participants|||Number
1309761|NCT02597582|Secondary|Postoperative Injected Analgesic Amount|The amount of injected form analgesic used (Meperidine 50 mg/ampule)|2 weeks||||Ampule||Standard Deviation|Mean
1309762|NCT02597582|Secondary|Postoperative Oral Analgesic Consumption|The amount of analgesic consumption via oral ingestion after operation|2 weeks||||capsules||Standard Deviation|Mean
1309763|NCT02597582|Secondary|Postoperative Subjective Pain Status|Visual analogue scale of subjective pain status after operation|2 weeks|Pain visual analogue scale (VAS) (no pain: 0, intolerable pain: 10)|||units on a scale||Standard Deviation|Mean
1309764|NCT02597582|Secondary|Postoperative Drainage Amount|The amount of drainage from closed system drainage tube|2 weeks||||ml||Standard Deviation|Mean
1309765|NCT02597582|Secondary|Intraoperative Blood Loss|Intraoperative blood loss was estimated by the sum of the volume in the suction bottle and the increased weight of wet gauzes containing blood after neck dissection.|1 day||||ml||Standard Deviation|Mean
1309766|NCT02597582|Primary|Opreation Duration|The duration from incision of cervial skin till the completion of lymph node dissection|1 day||||minutes||Standard Deviation|Mean
1309767|NCT02597543|Secondary|Mean Segmental T1 Values of the Left Ventricle|T1 values are obtained at the time of the cardiac MRI and indicate the amount of myocardial edema. This was a one time measurement. Outcome measure time frame indicates when T1 values of the left ventricle were obtained in relation to heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.||||Percentage of myocardium||Standard Deviation|Mean
1309768|NCT02597543|Secondary|Late Gadolinium Enhancement|Late gadolinium enhancement demonstrates myocardial scar by cardiac MRI. This is measured the day of the cardiac MRI scan and is a one time measurement. Time frame is measurement of late gadolinium enhancement from date of heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.||||percentage of myocardium||Standard Deviation|Mean
1309769|NCT02597543|Secondary|Re-transplantation|Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment.|10 months after enrollment (from date of cardiac MRI)||||Participants|||Count of Participants
1309770|NCT02597543|Secondary|Hospitalization for Cardiac Related Causes|Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months|10 months after enrollment (from date of cardiac MRI)||||Participants|||Count of Participants
1309771|NCT02597543|Secondary|Myocardial Ischemia/Infarction|Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period.|10 months after enrollment (when cardiac MRI was performed)||||Participants|||Count of Participants
1309772|NCT02597543|Primary|Myocardial Perfusion Reserve|Myocardial perfusion reserve calculates the increase in myocardial perfusion after stress in comparison to rest. Outcome measure time frame specifies when the myocardial perfusion reserve was obtained in relation to date of heart-transplant for each patient. This was a one time measurement made after heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.||||arbitrary units||Standard Deviation|Mean
1309773|NCT02597049|Secondary|Number of Participants With Adjudicated Cardiovascular (CV) Events|Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA).|Baseline through 24 Weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1309774|NCT02597049|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.~A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module."|Baseline through 24 Weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1309775|NCT02597049|Secondary|Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia|Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 24 Weeks|All participants who had at least one dose of study drug.|||Participants|||Count of Participants
1309776|NCT02597049|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L).|Baseline through 24 Weeks|All participants who received at least one dose of study drug.|||Number of events/participant/30 days||Standard Deviation|Mean
1309777|NCT02597049|Secondary|Change From Baseline in Fasting Glucagon at 24 Weeks|Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data).|Baseline, Week 24|All participants who received at least one dose of study drug and with non-missing baseline values and at least one post-baseline value at the specified time point.|||picomole per liter (pmol/L)||Standard Error|Least Squares Mean
1309778|NCT02597049|Secondary|Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks|The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, Week 24|All participants who received at least one dose of study drug and had baseline SMPG value and at least one post-baseline SMPG value.|||mg/dL||Standard Error|Least Squares Mean
1309779|NCT02597049|Secondary|Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks|LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA).|Baseline, Week 24|All participants who received at least one dose of study drug and had baseline and at least one post-baseline value.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
1309780|NCT02597049|Secondary|Change From Baseline in Body Weight at 24 Weeks|LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis|Baseline, Week 24|All participants who received at least one dose of study drug.|||kilograms (kg)||Standard Error|Least Squares Mean
1309781|NCT02597049|Secondary|Percentage of Participants With HbA1c <7%|Number of participants with an HbA1c value of <7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate.|24 Weeks|All participants who received at least one dose of Dulaglutide with HbA1c <7% at Week 24.|||percentage of participants|||Number
1309782|NCT02597049|Primary|Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)|LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.|Baseline, Week 24|All randomized participants who received at least one dose of study drug and had a baseline and post-baseline value excluding values collected after rescue medication.|||percentage of HbA1c||Standard Error|Least Squares Mean
1309783|NCT02597049|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)|Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.|Baseline, Week 24|All randomized participants who received at least one dose of study medication and had evaluable data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1324424|NCT02203630|Secondary|Location of Death||Up to 28 days||||Participants|||Count of Participants
1309784|NCT02596958|Secondary|Overall Survival|Overall survival was defined as the time (months) between the start of therapy and the date of death.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here 'number of participants analyzed' = participants assessed for this outcome measure.|||months||Standard Deviation|Mean
1309785|NCT02596958|Secondary|Percentage of Participants Who Died||Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
1309786|NCT02596958|Secondary|Progression Free Survival (PFS)|PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non­target lesions) or death. Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. PFS was estimated using Kaplan-Meier method.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||months||95% Confidence Interval|Median
1309787|NCT02596958|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion. PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
1309788|NCT02596958|Secondary|Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades|ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
1309789|NCT02596958|Secondary|Percentage of Participants With Best Tumor Response Over Time|Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent [%] decrease in the sum of the longest diameter [LD] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD], in addition to no new target lesions). PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
1309790|NCT02596958|Secondary|Number of Cycles of Systemic Therapy|Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.|||cycles||Standard Deviation|Mean
1309791|NCT02596958|Secondary|Percentage of Participants Who Withdrew or Modified Treatment|Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.|||percentage of participants|||Number
1309792|NCT02596958|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs|ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it or not.|||percentage of participants|||Number
1309793|NCT02596945|Secondary|Average Duration in Days Mircera Was Administered at a Stable Dose||Up to 9 months|MES population.|||days||Standard Deviation|Mean
1309794|NCT02596945|Secondary|Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|MES population.|||percentage of participants|||Number
1309873|NCT02590562|Secondary|Number of Participants With Abnormal Triglyceride Values|Normal range for triglyceride is <1.7 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1324425|NCT02203630|Secondary|28-day Mortality||Up to 28 days||||Participants|||Count of Participants
1309795|NCT02596945|Primary|Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9).|||percentage of participants|||Number
1309796|NCT02596867|Secondary|Assess the Safety, Toxicity and Adherence to Propranolol.|Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)|3 weeks|Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer, AEs were assessed during and after treatment|||Participants|||Count of Participants
1309797|NCT02596867|Primary|Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.|to evaluate effect of beta adrenergic blockades on breast cancer at by Ki67 percentage change- we are looking at at least 10% mean change in the tumor proliferative index following propranolol treatment|3 weeks|Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer.|||% mean difference of Ki67|||Number
1309798|NCT02596854|Primary|Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale|Images were read by board-certified radiologists who reviewed each image and assessed it on a 5 Point scale (1=unacceptable, 2=poor image quality, 3=Acceptable, 4=Good, 5=Excellent) based on the quality of the image (eg, signal-to-noise, clarity of anatomic boundaries, and other parameters). The outcome was reported as the mean diagnostic image quality score difference (synthetic – conventional).|1 day|Clinical indication for MRI of the brain based on site standard of care. This is a crossover study design where all subjects are enrolled into a single group producing two data types. The hypothesis test is a function of conventional and post-processed image quality within this patient group (one value summarized for this single population).|||units on a 5-point scale||Standard Deviation|Mean
1309799|NCT02596620|Primary|Percentage of Participants With Successful Eradication of H. Pylori|Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.|Negative results of H.pylori 4 weeks after eradication||||percentage of eradication||95% Confidence Interval|Number
1309800|NCT02596451|Primary|Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee|The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., ‘none’=0; ‘mild’=1, ‘moderate’=2; ‘severe’=3; ‘extreme’=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.|Baseline and week 4||||units on a scale||Standard Deviation|Mean
1309801|NCT02596321|Secondary|D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment|the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo|60 days from baseline||||kUA/L||Standard Deviation|Mean
1309802|NCT02596321|Secondary|D. Farinae Specific IgE Change From Baseline to End of Treatment|the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo|60 days from baseline||||kUA/L||Standard Deviation|Mean
1309803|NCT02596321|Secondary|D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment|secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment|60 days from baseline||||mg antibody/ml||Standard Deviation|Mean
1309804|NCT02596321|Primary|D. Farinae Specific IgG4 Change From Baseline to End of Treatment|primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment|60 days from baseline||||mg antibody/ml||Standard Deviation|Mean
1309805|NCT02596022|Primary|Number of Choices to Self-administer Cocaine (Out of 5 Choices)|Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.|24 hours post-infusion||||number of cocaine choices||Standard Deviation|Mean
1309806|NCT02596009|Primary|Peak Inspiratory Flows Rates Summary by Inhalation Devices - FAS|"The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.~This FAS dataset includes PIF data from additional patients with corrected inhaler internal resistance values."|Visit 2 (Day 1)|Full Analysis Set (FAS): The FAS set consisted of all randomized patients who carried out inhalation maneuver through at least one inhaler.|||L/min||Standard Deviation|Mean
1309807|NCT02596009|Primary|Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS|The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.|Visit 2 (Day 1)|Per-protocol set (PPS): This PPS population consisted of all randomized patients, who completed inhalation flow maneuvers through all three inhaler devices.|||L/min||Standard Deviation|Mean
1309808|NCT02595567|Primary|Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax|Feasibility of using ITPC's for the management of hepatic hydrothorax was assessed by the ability of patients to drain pleural effusions routinely via an indwelling tunneled pleural catheter for control of dyspnea related to pleural fluid accumulation. Feasibility was defined as successful catheter placement and improvement in shortness of breath following the procedure. Shortness of breath measurement was descriptive and self reported by patients on routine clinical follow up. Feasibility was also defined as patient ability to drain pleural effusions routinely at home. This was documented by patient logs documenting drainage.|From date of ITPC administration until the date of first documented complication such as infection that would require catheter removal or date of pleurodesis, whichever came first, assessed up to 12 months||||Participants|||Count of Participants
1324426|NCT02203630|Secondary|Length of Hospital Stay||Up to 28 days||||days||Full Range|Mean
1309809|NCT02595502|Primary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.|1 Week|The analysis population consists of subjects that completed the study without a major protocol deviation.|||units on a scale|Number of Observations|Standard Deviation|Mean
1309810|NCT02595450|Secondary|Overall Survival (OS) Time|Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.|Up to 6 years|As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.|||months||Full Range|Median
1309811|NCT02595450|Primary|Percentage of Participants With Best Overall Response|Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported.|||percentage of participants|||Number
1309812|NCT02595450|Primary|Progression-free Survival (PFS) Time|Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles.|||months||95% Confidence Interval|Median
1309813|NCT02594826|Secondary|Knowledge About Cervical Cancer|"Women's knowledge will be measured using a true/false scale. Responses will be combined to form a knowledge score.~Analysis of secondary outcome data is ongoing."|12 months||2017-10-31|10/2017||||
1309814|NCT02594826|Primary|Number of Women Who Receive a Pap Smear Test|Number of women who receive a Pap smear test in each group|12 months||||participants|||Number
1309815|NCT02593773|Secondary|Change From Baseline to Week 26 in Total Friedreich Ataxia Rating Scale Score (FARStot)|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions are assessed. FARStot scores range from 0 (normal) to 125 (most impairment). A negative change from baseline indicates improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
1309816|NCT02593773|Secondary|Number of FARS-mNeuro Responders and Non-Responders at Week 26|A participant was considered a responder if they had an improvement (decrease) of at least 3 points from Baseline at Week 26 for the FARS-mNeuro score. The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment).|Week 26|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
1309817|NCT02593773|Secondary|Change From Baseline at Week 26 in Timed 25-Foot Walk (T25FW)|The T25FW is a quantitative measure of lower extremity function. Participants are directed to 1 end of a clearly marked 25-foot course and instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance, and the score for the test is the average of the 2 walks (after reciprocal transformation). Participants may use assistive devices when performing this task, with the same assistive device used at each assessment. A negative change from Baseline indicates improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
1309869|NCT02590562|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population|||tender joint count||Standard Deviation|Mean
1309910|NCT02590003|Secondary|Progression-free Survival||start of treatment to disease progression, up to 12 months|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.|||Participants|||Count of Participants
1309818|NCT02593773|Secondary|Change From Baseline to Week 26 in Activities of Daily Living (ADL) Score|Participants and/or their caregivers rated 9 areas of daily living skills (speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function) on a 5-point scale (0=normal, 4=greatest loss of function) with allowable increments of 0.5 if the participant or caregiver strongly felt that a task falls between 2 scores. ADL scores can range from 0 (normal) to 36 (greatest loss of function). A negative change from baseline indicates improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
1309819|NCT02593773|Primary|Change From Baseline to Week 26 in the Friedreich's Ataxia Rating Scale (FARS)-mNeuro Score|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment). A negative change from baseline is an improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
1309820|NCT02593773|Primary|Number of Participants With Positive/Negative Neutralizing Antibody (NAb) and Anti-Drug Antibody (ADA) Tests|NAb testing only for those participants with a positive ADA test. Baseline is defined as the last non-missing measurement/assessment on the date of Week 26 Visit from study HZNP-ACT-301 (NCT02415127). If this measurement was missing or otherwise unavailable, it was the last non-missing measurement/assessment on or prior to first dose in this study. If the participant discontinued the study, then premature withdrawal assessments were mapped to the nearest scheduled visit based on schedule of the assessment and the study day. If the mapped visit was already available then the visit was mapped to the next schedule visit. Last on study assessment is the last non-missing post-baseline assessment for each participant.|Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 [NCT02415127]), Week 4, Week 13, Week 26, and Week 28 (follow-up safety visit)|Safety Population, defined as all participants who received at least 1 dose of open-label study drug after the Baseline Visit. Participants with an assessment at each time point are presented.|||participants|||Number
1309821|NCT02593773|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the investigational product. A TEAE is any adverse change from the subject’s baseline condition, including any laboratory test value abnormality judged as clinically significant by the investigator, that occurs on or after the date of the first dose of study drug administered at home and throughout the duration of the clinical study, whether the adverse event is considered related to the treatment or not. An SAE is an AE that results in death, is life-threatening, results in persistent or significant disability or incapacity, inpatient hospitalization or prolongation of an existing hospitalization, is a congenital anomaly or birth defect, or other medically important event.|Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 [NCT02415127]) through Week 28 (follow-up safety visit)|Safety Population, defined as all participants who received at least 1 dose of open-label study drug after the Baseline Visit.|||participants|||Number
1309822|NCT02592655|Primary|Investigator Limb Occlusion Assessment|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered a successful occlusion. This assessment was made by the investigator and ultrasonographer applying the intervention.|For 1 sustained minute after application of each tourniquet intervention.||||Participants|||Count of Participants
1309823|NCT02592655|Primary|Radiologist Limb Occlusion Assessment|"Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.~The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist."|For 1 sustained minute after application of each tourniquet intervention.|"One ultrasound image from one of the participants of the pneumatic tourniquet (ATS) group failed to capture anatomy and was therefore not included in the analysis.~One ultrasound image from one of the participants of the windlass tourniquet (SOFTT-W) group failed to capture anatomy and was therefore not included in the analysis."|||Participants|||Count of Participants
1309824|NCT02591537|Secondary|Scar Quality Analysis; Colorimeter|Scar quality was to be assessed for each study participant using a colorimeter at day 42. A colorimeter was to be used to measure the extent of erythema, and melanin content, of the skin. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.|Day 42|Data were not collected.||||||
1309825|NCT02591537|Secondary|Scar Quality Analysis; Elastometer|Scar quality was to be assessed for each study participant using an elastometer at day 42. An elastometer is used to assess scar elasticity. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.|Day 42|Data were not collected.||||||
1309870|NCT02590562|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population|||swollen joint count||Standard Deviation|Mean
1309826|NCT02591537|Secondary|Scar Quality Analysis; Visual Analogue Scale|Scar quality of each study participant was assessed by using the Visual Analogue Scale (VAS) at day 42. The VAS is an 11-point scale that ranges from 0 (normal skin) to 10 (worst possible scar). The values on the scale indicate the observer's global impression of the scar (lower numbers are better than higher numbers).|Day 42|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement.|||units on a scale|wounds|Standard Deviation|Mean
1309827|NCT02591537|Secondary|Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)|Scar quality will be assessed and analyzed between the two groups using the Modified Vancouver Scar Scale at day 42. The MVS assessment is the tool that the Investigator will use to evaluate scar pliability (0 points = normal, 1 = supple, 2 = yielding, 3 = firm, 4 = adherent), height (0 = normal, 1 = 1-2 mm, 2 = 3-4 mm, 3 = 5-6 mm, 4 = > 6 mm), vascularity (0 = normal, 1 = pink, 2 = red, 3 = purple), and pigmentation (0 = normal, 1 = slight, 2 = moderately, 3 = severely). An average score for each participant was calculated by combining scores from each subscale. Average participant scores in each study group were combined to produce a grand mean and standard deviation for each group (reported below).|Day 42|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement.|||units on a scale|wounds|Standard Deviation|Mean
1309828|NCT02591537|Secondary|Biopsy & Histology of Wounds.|Biopsies will be taken from all wounds at day 28. Analysis of tissue samples will specifically evaluate differences and rates of collagen deposition, angiogenesis and re-epithelialization between the two study arms.|Day 28|Each participant was assigned to both study groups (acted as her own control). Samples were collected, but not analyzed because the comparative broad healing endpoints did not provide compelling evidence for tissue processing. No data are presented because the Outcome Measure has zero total participants analyzed.||||wound biopsies||
1309829|NCT02591537|Secondary|Pain on Test Versus Control Side Using a Wong-Baker Scale.|Subjects will report pain level on each side of their abdomen at day 14. The Wong-Baker scale is: 0 points = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. A grand mean and standard deviation (reported below) were determined by combining participant scores.The identical group mean and standard deviation values reported below are correct.|Day 14|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. Five participants did not report their day 14 measurements.|||units on a scale|wounds|Standard Deviation|Mean
1309830|NCT02591537|Secondary|Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.|Wound degree of epithelialization percent change by digital photography at day 14.|Day 14|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.|||percentage of epithelialization|wounds|Standard Deviation|Mean
1309831|NCT02591537|Primary|Healing in Days.|Wound healing will be defined as 90% re-epithelialization. Mean time to healing will be compared between the OxyGenesys treated sites and the control treated sites.|14 days|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.|||days|wounds|Standard Deviation|Mean
1309832|NCT02591290|Other Pre-specified|Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination|Solicited injection (Inj.) site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference), erythema and swelling (Grade 1: >=25 to <=50 mm; Grade 2: >=51 to <=100 mm; Grade 3: >100 mm); Solicited systemic reactions: Fever (Grade 1: >=37.5 degree Celsius to <=38.4 degree Celsius, Grade 2: >=38.5 degree Celsius to <=38.9 degree Celsius, Grade 3: >=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.|Within 7 days post-vaccination 1, Within 7 days post-vaccination 2|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
1309833|NCT02591290|Other Pre-specified|Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR in the serum specimens. Number of participants with >=4-fold rise in each meningococcal serogroups antibody titer at Day 28 post-vaccination 1 and at Day 28 post-vaccination 2 were reported.|Day 28 post-vaccination 1, Day 28 post-vaccination 2|PP analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.|||Participants|||Count of Participants
1309834|NCT02591290|Primary|Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).|Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2|Per Protocol (PP) analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.|||Participants|||Count of Participants
1309835|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.||Three months.|Bellow concentration data of LDL-C was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
1309836|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.||Three months.|Bellow concentration data of TG was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
1324427|NCT02203630|Secondary|Length of ICU Stay||Up to 28 days||||days||Full Range|Mean
1309841|NCT02591056|Primary|Change in Combined Circumference Measurements|Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.|Baseline and 6 Weeks||||inches||Standard Deviation|Mean
1309842|NCT02590939|Secondary|Pain Score 24 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)|24 hours||||units on a scale||Standard Deviation|Mean
1309843|NCT02590939|Secondary|Pain Score 2 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)|2 hours||||units on a scale||Standard Deviation|Mean
1309844|NCT02590939|Secondary|Pain Score 24 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)|24 hours||||percent change||Standard Deviation|Mean
1309845|NCT02590939|Secondary|Rescue Medication 24 Hours|Number of patients not having required rescue medication within 24 hours|24 hours||||Participants|||Count of Participants
1309846|NCT02590939|Secondary|Pain Score 2 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)|2 hours||||percent change||Standard Deviation|Mean
1309847|NCT02590939|Secondary|Rescue Medication 2 Hours|Number of patients not having required rescue medication at 2 hours|2 hours||||Participants|||Count of Participants
1309848|NCT02590939|Primary|Pain Score 1-hour|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline|1 hour||||units on a scale||Standard Deviation|Mean
1309849|NCT02590939|Primary|Pain Score 1-hour|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline|1 hour||||percent change||Standard Deviation|Mean
1309850|NCT02590588|Secondary|Quality of Life|Evaluate quality of life according to Functional Assessment of Cancer Therapy Lymphoma Subscale (FACT-Lym) assessment tool|3 months|'There was only one patient enrolled and he did not remain on study long enough for his first protocol-specified quality of life assessment||||||
1309851|NCT02590588|Secondary|Evaluate Safety and Tolerability of Agent|Number of Participants With Treatment-Related Adverse Events as Assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0|3 months|There was only one patient enrolled and he did experience treatment-related adverse events.|||Participants|||Count of Participants
1309852|NCT02590588|Secondary|Organ Response|Number of patients with organ response using standard AL amyloidosis criteria.|3 months|Number of patients with organ response using standard AL amyloidosis criteria.||||||
1309853|NCT02590588|Secondary|Progression Free Survival|Evaluate time to progression|1 year|The evaluation of progression-free survival requires that a patient responds, and then progresses. There was only one patient enrolled and he did not remain on study long enough for his first 3 month response evaluation.||||||
1309854|NCT02590588|Primary|Overall Response|Evaluate hematologic response according to standard criteria|3 months|Number of participants with hematologic response is zero. There was only one patient enrolled and he did not remain on study long enough for his first 3 month response evaluation.||||||
1309855|NCT02590562|Secondary|Participant's Pain Assessment|Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||cm||Standard Deviation|Mean
1309856|NCT02590562|Secondary|Participant’s Fatigue Assessment|Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||cm||Standard Deviation|Mean
1309857|NCT02590562|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from “no difficulty” to “unable to do”, corresponding to scores from 0 to 3. HAQ total score = sum of each of the 20 items' scores, with a summary score ranging from 0 to 60, where higher score indicates greater disability.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309858|NCT02590562|Secondary|Patient’s Global Assessment (PtGA) of Disease Activity|PtGA of disease activity was measured on a 0 to 10 cm VAS, with 0 cm = very well controlled and 10 cm = very poorly controlled.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||cm||Standard Deviation|Mean
1309859|NCT02590562|Secondary|Physician’s Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 10 centimeter (cm) VAS, with 0 cm = no disease activity and 10 cm = extreme disease activity.|Day 1 (enrollment visit)|Overall Population|||cm||Standard Deviation|Mean
1309871|NCT02590562|Secondary|Number of Participants With Abnormal Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309872|NCT02590562|Secondary|Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
1309860|NCT02590562|Secondary|DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309861|NCT02590562|Secondary|DAS28 by Duration of Treatment of Biological Agent|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure in respective arms.|||units on a scale||Standard Deviation|Mean
1309862|NCT02590562|Secondary|Number of Participants With Duration of Treatment of Biological Agent|Number of participants with duration of treatment of biological agent <3 months, >= 3 to <6 months, >= 6 to <12 months, and >= 12 months.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
1309863|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309864|NCT02590562|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309865|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309866|NCT02590562|Secondary|Clinical Disease Activity Index (CDAI) Scores|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician’s Global Assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1309867|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309868|NCT02590562|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and Patient’s Global Assessment (PtGA) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1314757|NCT02438540|Secondary|Body Mass Index (BMI)|change of BMI. Body height was measured to an accuracy of +/-0.1cm. BMI was calculated by dividing weight (kg) into height (squared m²).|baseline, week 3||||Kg/m²||Standard Deviation|Mean
1309874|NCT02590562|Secondary|Triglyceride Values|Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
1309875|NCT02590562|Secondary|Number of Participants With Positive Rheumatoid Factor (RF)|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Central lab was not used in this study; the definitions of positive RF followed participating hospitals’ standardized criteria. CRF collected data as “positive” or “negative” directly.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309876|NCT02590562|Secondary|Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody|ACCP antibodies are important markers of bone erosion in RA. Central lab was not used in this study; the definitions of positive ACCP followed participating hospitals’ standardized criteria. CRF collected data as “positive” or “negative” directly.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309877|NCT02590562|Secondary|Number of Participants With Anemia|Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309878|NCT02590562|Secondary|Hemoglobin Values|Hemoglobin levels were measured in gram per liter (g/L). Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||g/L||Standard Deviation|Mean
1309879|NCT02590562|Secondary|Number of Participants With Abnormal ESR Values|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. Central lab was not used in this study; the definitions of abnormal ESR followed participating hospitals’ standardized criteria. CRF collected data as directly “normal” or “abnormal”.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309880|NCT02590562|Secondary|Erythrocyte Sedimentation Rate (ESR) Values|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mm/hr||Standard Deviation|Mean
1309881|NCT02590562|Secondary|Number of Participants With Abnormal CRP Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Central lab was not used in this study; the definitions of abnormal CRP followed participating hospitals’ standardized criteria. Case report form (CRF) collected data as directly “normal” or “abnormal”.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309882|NCT02590562|Secondary|C-Reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
1309883|NCT02590562|Secondary|Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309884|NCT02590562|Secondary|Number of Participants With Concurrent RA Extra-articular Symptoms|Number of participants with concurrent RA extra-articular symptoms including RA subcutaneous nodule, RA vasculitis, interstitial pneumonia, Felty’s syndrome, and other symptoms were presented. One participant could have more than one concurrent RA extra-articular symptoms.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309885|NCT02590562|Secondary|Number of Participants With RA Duration|Number of participants with RA duration of <= 6 months, >6 months and <= 3 years, >3 years and <= 10 years, and 10 years.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309886|NCT02590562|Secondary|RA Duration Since Diagnosis|RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||years||Standard Deviation|Mean
1309887|NCT02590562|Secondary|Number of RA Related Operations|RA related operations also included prosthesis.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||RA related operations||Standard Deviation|Mean
1309888|NCT02590562|Secondary|Height||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||centimeters (cm)||Standard Deviation|Mean
1309889|NCT02590562|Secondary|Weight||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||kilograms||Standard Deviation|Mean
1309890|NCT02590562|Secondary|Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage||Day 1 (enrollment visit)|Overall Population|||participants|||Number
1309891|NCT02590562|Primary|Average Daily Dose of Each Previously Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||mg/day||Standard Deviation|Mean
1309911|NCT02590003|Secondary|Overall Response Rate||start of treatment to disease progression/recurrence, up to 12 months|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.|||Participants|||Count of Participants
1309892|NCT02590562|Primary|Average Daily Dose of Each Currently Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||mg/day||Standard Deviation|Mean
1309893|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||weeks||Standard Deviation|Mean
1309894|NCT02590562|Primary|Average Weekly Dose of Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||mg/week||Standard Deviation|Mean
1309895|NCT02590562|Primary|Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs|Number of participants using one concomitant csDMARD, two concomitant csDMARDs (methotrexate + hydroxychloroquine [HCQ], methotrexate + salazosulfapyridine [SASP], methotrexate+ leflunomide, SASP + HCQ, and other combinations), or three (or more) concomitant csDMARDs (methotrexate + SASP + HCQ, and other combinations) are presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309896|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant External Medicine||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||weeks||Standard Deviation|Mean
1309897|NCT02590562|Primary|Average Weekly Dose of Each Concomitant Glucocorticoid|Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone [BMZ] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified concomitant glucocorticoid treatment.|||mg/week||Standard Deviation|Mean
1309898|NCT02590562|Primary|Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past|Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309899|NCT02590562|Primary|Number of Participants With Previous Use of the Same Biological Agent|Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
1309900|NCT02590562|Primary|Average Duration of Treatment for Each Biological Agent|Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. n = participants with specified treatment of biological agent.|||weeks||Standard Deviation|Mean
1309901|NCT02590562|Primary|Average Weekly Dose of Treatment for Each Biological Agent|Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified treatment of biological agent.|||milligrams (mg) per week||Standard Deviation|Mean
1309902|NCT02590562|Primary|Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents|Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
1309903|NCT02590562|Primary|Number of Participants Receiving a Biological Agent Concomitant With Other Drugs|Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
1309904|NCT02590562|Primary|Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs [NSAIDs], and biological agent + glucocorticoid + NSAIDs.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
1309905|NCT02590003|Secondary|Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)|The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. Symptoms were measured following 4 21-day cycles of chemotherapy.|week 12|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment, these data were not collected at week 12||||||
1309906|NCT02590003|Secondary|Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)|The higher the score, the greater the symptoms. The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained. Symptoms were measured following 2 21-day cycles of chemotherapy.|week 6|Only 2 patients were assessed at this timepoint.|||units on a scale||Standard Deviation|Mean
1309907|NCT02590003|Secondary|Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)|The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained.|baseline||||units on a scale||Standard Deviation|Mean
1309908|NCT02590003|Secondary|Grade 3-5 Adverse Events|Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)|Up to week 13||||Participants|||Count of Participants
1309909|NCT02590003|Secondary|Overall Survival||Up to 12 months|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.|||Participants|||Count of Participants
1309915|NCT02588872|Secondary|Biologic Testing of Synovial Fluid Via ELISA Assays|ELISA analysis will be performed for the following biological markers: IL-1β, IL-1ra, IL-6, IL-8, TNFα|Primary outcome will be change from pre-treatment to 6-month post treatment.|IL-1B|||units on a scale||Standard Error|Mean
1309916|NCT02588872|Secondary|Lysholm Knee Score|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.||||units on a scale||Standard Error|Mean
1309917|NCT02588872|Secondary|Western Ontario and McMaster Universities Arthritis Index|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-treatment, 6-months post treatment, and finally at 1-year post treatment will be documented for the purpose of trending data.||||units on a scale||Standard Error|Mean
1309918|NCT02588872|Secondary|Visual Analogue Scale (VAS)|This is a scale from 1-100, 100 being the worst pain imaginable and 1 being no pain at all that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.||||units on a scale||Standard Error|Mean
1309919|NCT02588872|Primary|International Knee Documentation Committee Score (IKDC|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.|9 HA patients and 3 PRP from the original cohort were lost to follow up which is why 50 HA and 49 PRP patients were included in final analysis.|||units on a scale||Standard Error|Mean
1309920|NCT02588599|Secondary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 6 months after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 6 Months|Each participant in this study had only one great toenail treated.|||millimeters|Participants|Standard Deviation|Mean
1309921|NCT02588599|Primary|Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|6 Months|Each participant had only one great toenail treated in this study.|||Percent of Toenails|Participants||Number
1309922|NCT02587819|Post-Hoc|Change in Lesion Size.|BCC lesion area was measured at Baseline and after 28 days treatment. Percantage change in lesion area was caculated.|28 days|Final area of lesion was not recorded for one subject.|||percentage change in tumour area||Standard Error|Mean
1309923|NCT02587819|Primary|Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.|The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).|8 weeks|Anti sheep IgG antibody titres were measured from 21 subjects at screening and baseline, 20 subjects at Visit 6 (Day 29 EOT) and 19 subjects at Visit 8 (Day 57 follow up). The percentage of patients with detectable anti sheep antibodies is reported.|||percentage of subjects|||Number
1309924|NCT02587819|Primary|Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.|To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.|28 days|At all timepoints, the serum concentration of sheep IgG was too low to be quantified in most of the subjects. One subject had measurable sheep IgG at 1 hr post dose at Visit 6 (EOT) and 3 other subjects had measurable sheep IgG at predose timepoints. In outcome measure below NA represents readings less than lower limit of quantification.|||ng/ml||Full Range|Median
1309925|NCT02587819|Primary|Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)|Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.|8 weeks|All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.|||participants|||Number
1309926|NCT02587234|Secondary|Change in Action Research Arm Test (ARAT)|"Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline.~The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).~Performance on each item is rated on a 4-point ordinal scale ranging from:~3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty~1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57)."|baseline, post-intervention, 1-month follow-up|Two subjects from the Sham PNS group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
1309927|NCT02587234|Secondary|Change in Fugl Meyer Assessment Motor Score|Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.|baseline, post-intervention, 1-month follow-up|Two subjects from the Sham PNS group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
1324428|NCT02203630|Secondary|Number of Participants Rehospitalized After Discharge||Up to 28 days||||Participants|||Count of Participants
1309928|NCT02587234|Primary|Change in Wolf Motor Function Test (WMFT), Timed Portion|Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline|baseline, post-intervention, 1-month follow-up|Two subjects in the Sham PNS group were lost to follow-up.|||log(seconds)||95% Confidence Interval|Mean
1309929|NCT02587117|Secondary|Burning Sensation or Pain by Using NRS (Numerical Rating Scale)|Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score.|8 weeks minus baseline||||Scores on a scale||Standard Deviation|Mean
1309930|NCT02587117|Primary|Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score|Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion <1 cm2; score 2: lesion 1-3 cm2; score 3= lesion >3 cm2. Ulceration: score 0= no lesion; score 1= lesion <1 cm2; score 2= lesion 1-3 cm2; score 3= lesion >3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 & 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome & zero value represent no lesion.|8 weeks minus baseline||||Scores on a scale||Standard Deviation|Mean
1309931|NCT02586805|Secondary|Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks during day 14 after study drug administration through day 182 was analyzed by the same poisson regression model as in the primary endpoint analysis.|From Day 14 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
1309932|NCT02586805|Secondary|Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Moderate and severe investigator-confirmed HAE attacks were the attacks that were moderate or severe as per the HAE attack assessment and reporting procedures (HAARP) defined severity. The overall severity of attack was determined by the investigator using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Rate of moderate or severe investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.|From Day 0 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
1309933|NCT02586805|Secondary|Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.|From Day 0 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
1309934|NCT02586805|Primary|Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.|From Day 0 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
1309935|NCT02586506|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study|Participants’ ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 28|mITT Population|||Percentage||95% Confidence Interval|Number
1309936|NCT02586506|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study|Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 28|mITT Population|||Percentage||95% Confidence Interval|Number
1309937|NCT02586506|Primary|The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study.|Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution.|Day 28|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2.|||Percentage||95% Confidence Interval|Number
1310351|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants|8 weeks||||errors|||Number
1309938|NCT02586493|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study.|Participants’ ability to correctly use the ELLIPTA inhaler was assessed at Visit 1 and Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 30|mITT Population|||Percentage of Participants||95% Confidence Interval|Number
1309939|NCT02586493|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study.|Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 30|mITT Population|||Percentage of Participants||95% Confidence Interval|Number
1309940|NCT02586493|Primary|Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate Correct Use of the Inhaler at the End of the Study.|Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). “Easy to use” was defined as the combination of an “easy” or “very easy” rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised).|Day 30|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2. Only participants with data available at the analysis time point were analyzed.|||Percentage||95% Confidence Interval|Number
1309941|NCT02585999|Secondary|NGMN Levels Over 12 Weeks of Continuous Patch Use|Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN|12 weeks|Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early [lost to follow up]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.|||ng/ml||Standard Deviation|Mean
1309942|NCT02585999|Primary|Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use|Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2|Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removed|Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early [lost to follow up]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.|||pg/ml||Standard Deviation|Mean
1309943|NCT02585895|Secondary|Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio||Baseline and Week 4|Randomized participants with non-missing data|||percent change||Standard Error|Least Squares Mean
1309944|NCT02585895|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol||Baseline and Week 4|Randomized participants with non-missing data|||percent change||Standard Error|Least Squares Mean
1309945|NCT02585895|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol||Baseline and week 4|Randomized participants with non-missing data|||percent change||Standard Error|Least Squares Mean
1309946|NCT02585895|Primary|Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy|"Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4:~participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was < 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group.~Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance."|Week 5 and week 6|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1309947|NCT02585778|Secondary|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis|Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|mITT population.|||glucose lowering treatments||Standard Deviation|Mean
1309948|NCT02585778|Secondary|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis|Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|ITT population.|||glucose lowering treatments||Standard Deviation|Mean
1309949|NCT02585778|Secondary|Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = daily insulin dose/kg at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||U/kg||Standard Deviation|Mean
1309950|NCT02585778|Secondary|Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis|Absolute change = daily insulin dose/kg at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|ITT population . Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||U/kg||Standard Deviation|Mean
1309951|NCT02585778|Secondary|Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = total daily insulin dose at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||units (U)||Standard Deviation|Mean
1309952|NCT02585778|Secondary|Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis|Absolute change = total daily insulin dose at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|ITT population . Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||units (U)||Standard Deviation|Mean
1309953|NCT02585778|Secondary|Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = FPG value at specified weeks minus FPG value at baseline.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
1309954|NCT02585778|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis|Absolute change = FPG value at specified weeks minus FPG value at baseline.|Baseline, Weeks 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
1309955|NCT02585778|Secondary|Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
1309956|NCT02585778|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis|Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.|Baseline, Weeks 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
1309957|NCT02585778|Secondary|Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis|LDL-C particle size was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle size value on- or off-treatment (LDL-C particle size ITT population).|||percent change||Standard Error|Least Squares Mean
1309958|NCT02585778|Secondary|Percent Change From Baseline in LDL-C Particle Number at Week 24 - ITT Analysis|LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle number value on- or off-treatment (LDL-C particle number ITT population).|||percent change||Standard Error|Least Squares Mean
1309959|NCT02585778|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach for handling of missing data followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1309960|NCT02585778|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1309961|NCT02585778|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach for handling of missing data followed by robust regression model. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1309962|NCT02585778|Secondary|Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|Non-HDL-C mITT population.|||percentage of participants|||Number
1309963|NCT02585778|Secondary|Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment (Non-HDL-C mITT population).|||percentage of participants|||Number
1309964|NCT02585778|Secondary|Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach (for T1DM participants) and multiple imputation approach model (for T2DM participants) including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). The maximum likelihood estimate did not exist as response rate was zero in a treatment group of T1DM participants.|Up to Week 24|mITT population.|||percentage of participants|||Number
1309965|NCT02585778|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|mITT population.|||percentage of participants|||Number
1309966|NCT02585778|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1310041|NCT02582684|Primary|Virologic Status at Week 24|"Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 24 Window are provided below.~Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition)."|At 24 weeks after study entry|All eligible participants enrolled.|||Participants|||Count of Participants
1309967|NCT02585778|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1309968|NCT02585778|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1309969|NCT02585778|Secondary|Percent Change From Baseline in Measured LDL-C at Week 12 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment at Week 12 (Measured LDL-C ITT population at Week 12).|||percent change||Standard Error|Least Squares Mean
1309970|NCT02585778|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment at Week 12 (ITT population at Week 12).|||percent change||Standard Error|Least Squares Mean
1309971|NCT02585778|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment (Measured LDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1309972|NCT02585778|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1309973|NCT02585778|Primary|Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)|Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days).|From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks)|Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).|||percentage of participants|||Number
1309974|NCT02585778|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1309975|NCT02585245|Primary|The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen|Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives)|24 hr within admission to the hospital||||percentage of participants||95% Confidence Interval|Number
1309976|NCT02584790|Secondary|The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern|"Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D~The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated."|Post-radiotherapy eight weeks|NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40|||Percentage of participants|||Number
1309977|NCT02584790|Secondary|Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group|"Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D~The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated."|Post-radiotherapy eight weeks|NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40|||Participants|||Count of Participants
1309978|NCT02584790|Primary|Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient|"4 grading of NBI vessel patterns can be identified in those post-radiotherapy 8 weeks NPC patients.~Grade A: normal vessel size and length, regular pattern Grade B: normal vessel size, short, regular spiderweb like pattern Grade C: irregular vessel size and length, distorted and irregular pattern Grade D: thickened vessel size, elongated, distorted, and earthworm pattern"|Post-radiotherapy 8th week||||participants|||Number
1309979|NCT02584686|Secondary|SEP-Q3 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) after treatment.~This analysis compares the number of patients who were able to maintain their erection long enough to complete sexual intercourse after treatment in the (BTX) A group versus the Saline group."|1 month||||participants|||Number
1309980|NCT02584686|Secondary|SEP-Q3 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) before treatment."|Baseline||||participants|||Number
1314908|NCT02434497|Secondary|Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline ApoB/ApoA-1|participants|95% Confidence Interval|Geometric Mean
1309981|NCT02584686|Secondary|SEP-Q2 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?) after treatment.~This analysis compares the number of patients who were able to perform vaginal intromission (insert the penis into the partner’s vagina) after treatment in the (BTX) A group versus the Saline group."|1 month||||participants|||Number
1309982|NCT02584686|Secondary|SEP-Q2 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?)"|Baseline||||participants|||Number
1309983|NCT02584686|Secondary|Global Assessment Question (GAQ)|"Assessment of the effect of treatment by asking Has the treatment you have been taking improved your erectile function?. The number answering Yes in both the treatment and control groups are calculated."|1 month||||participants|||Number
1309984|NCT02584686|Secondary|SHIM Score After Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|1 month||||units on SHIM scale||Standard Deviation|Mean
1309985|NCT02584686|Secondary|SHIM Score Before Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|Baseline||||units on the SHIM scale||Standard Deviation|Mean
1309986|NCT02584686|Secondary|EHS After Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI after 2 weeks.~The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).~0 – Penis does not enlarge.~– Penis is larger, but not hard.~– Penis is hard, but not hard enough for penetration.~– Penis is hard enough for penetration, but not completely hard.~– Penis is completely hard and fully rigid. The average score is reported for each group."|2 weeks||||units on EHS scale||Standard Deviation|Mean
1309987|NCT02584686|Secondary|EHS Before Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI at baseline.~The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).~0 – Penis does not enlarge.~– Penis is larger, but not hard.~– Penis is hard, but not hard enough for penetration.~– Penis is hard enough for penetration, but not completely hard.~– Penis is completely hard and fully rigid. The average score is reported for each group."|Baseline||||units on EHS scale||Standard Deviation|Mean
1309988|NCT02584686|Primary|Cavernosal Artery Mean PSV After Treatment|Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.|2 weeks||||cm/s||Standard Deviation|Mean
1309989|NCT02584686|Primary|Cavernosal Artery Mean PSV Before Treatment|Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups, before treatment.|Baseline||||cm/s||Standard Deviation|Mean
1309990|NCT02584673|Secondary|Number of Times Needle Needs Repositioning||Immediately following intervention (within 2 hours)|This data was not collected||||||
1309991|NCT02584673|Secondary|Number of Attempts|Number of instrument pricks before target is reached|Immediately following intervention (within 2 hours)|This data was not collected||||||
1309992|NCT02584673|Secondary|Clinician Rating of the Device||Immediately following intervention (within 2 hours)|This data was not collected||||||
1309993|NCT02584673|Primary|Time Needed to Correctly Insert the Arterial or Midline Catheter.||Immediately following intervention (within 2 hours)||||Seconds||Standard Deviation|Mean
1309994|NCT02584660|Secondary|Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire|The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant’s level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.|Day 7|The safety population included all randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
1309995|NCT02584660|Secondary|Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)|ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 [how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from ‘Not at all’ to ‘Extremely’ on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.|Day 90|The safety population included all randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
1309996|NCT02584660|Secondary|Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason|Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.|Up to 30 and 90 Days|The ITT included all participants who were randomized into the study.|||Days||Standard Deviation|Mean
1309997|NCT02584660|Secondary|Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding|Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.|Up to 7, 14, 30 and 90 Days|The ITT included all participants who were randomized into the study.|||Percentage of Participants|||Number
1324429|NCT02203630|Secondary|Readmission to ICU||Up to 28 days|data was not collected||||||
1309998|NCT02584660|Secondary|Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death|Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.|Up to 7, 14, 30, and 90 Days|The ITT included all participants who were randomized into the study.|||Percentage of participants|||Number
1309999|NCT02584660|Primary|Mean Duration of Hospitalization|Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.|Up to Day 30|The intention to treat analysis set (ITT) included all participants who were randomized into the study.|||Days||Standard Deviation|Mean
1310000|NCT02584504|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
1310001|NCT02584504|Secondary|Percent Change From Baseline in Fasting Triglycerides (TGs) at Week 12: ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Mean
1310002|NCT02584504|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12- ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1310003|NCT02584504|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Mean
1310004|NCT02584504|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- On-Treatment Analysis|Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heFH participants or non-FH participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|Up to Week 12|mITT population.|||percentage of participants|||Number
1310005|NCT02584504|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- ITT Analysis|Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heterozygous familiar hypercholesterolemia (heFH) participants or non-familial hypercholesterolemia (non-FH) participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 12|ITT population.|||percentage of participants|||Number
1310006|NCT02584504|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12- ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1310007|NCT02584504|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12- On-treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|From Baseline to Week 12|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on- treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
1310008|NCT02584504|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1310009|NCT02584504|Secondary|Percent Change From Baseline in Apo-B at Week 12- On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data at from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|From Baseline to Week 12|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population).|||percent change||Standard Error|Least Squares Mean
1310010|NCT02584504|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1310076|NCT02581475|Secondary|Duration of the Total Colonoscopy Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.||||minute||Standard Deviation|Mean
1310011|NCT02584504|Secondary|Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12- On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection) and assigning a weight of 0.5 for Week 10 and 12 time points.|From Baseline to Week 12|mITT population.|||percent change||Standard Error|Least Squares Mean
1310012|NCT02584504|Secondary|Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment and assigning a weight of 0.5 for Week 10 and 12 time points.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Least Squares Mean
1310013|NCT02584504|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12- On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|From Baseline to Week 12|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1310014|NCT02584504|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 12|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1310015|NCT02583425|Secondary|The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)||28 days Baseline period and 28 days of Treatment period (Total 56 days)||||Number of doses of acute medication used||Standard Deviation|Mean
1310016|NCT02583425|Primary|The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)||28 days Baseline period and 28 days of Treatment period (Total 56 days)||||Hours||Standard Deviation|Mean
1310017|NCT02582983|Primary|Number of Participants With Premature Withdrawal Due to Adverse Events||Up to 96 weeks|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.|||participants|||Number
1310018|NCT02582983|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe."|Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.|||participants|||Number
1310019|NCT02582970|Secondary|Mean Direct Medical Cost for Cancer Related Medical Care Utilization|Direct medical cost included cost of out-patient consultation and cost of hospitalization.|Baseline up to approximately 3 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Number Analyzed = participants who were evaluable for specified categories of this outcome measure.|||Thousands in New Taiwan Dollar||Standard Deviation|Mean
1310020|NCT02582970|Secondary|Number of Participants With Best Overall Response|The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.|Baseline up to approximately 3 years|ITT population.|||participants|||Number
1310021|NCT02582970|Secondary|Progression-Free Survival Time|Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.|Baseline up to approximately 3 years|ITT population.|||months||95% Confidence Interval|Median
1310022|NCT02582970|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).|Baseline up to approximately 3 years|ITT population.|||percentage of participants|||Number
1310023|NCT02582970|Secondary|Duration of Survival|Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.|Baseline up to approximately 3 years|ITT population.|||months||95% Confidence Interval|Median
1310024|NCT02582970|Secondary|Percentage of Participants Who Died||Baseline up to approximately 3 years|ITT population.|||percentage of participants|||Number
1310025|NCT02582970|Primary|Percentage of Participants With Adverse Events|An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Baseline up to approximately 3 years|ITT population.|||percentage of participants|||Number
1310026|NCT02582684|Secondary|Number of Participants With Grade 3 of Higher Adverse Events|Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|from study treatment dispensation through up to week 52 or until study discontinuation|All eligible participants enrolled.|||Participants|||Count of Participants
1310027|NCT02582684|Secondary|Creatinine Clearance|Creatinine clearance was estimated by the Cockcroft-Gault equation.|Baseline, weeks 4, 12, 24, 32, 40 and 48|All eligible participants enrolled with creatinine clearance results available at a given time point.|||mL/min||Inter-Quartile Range|Median
1310028|NCT02582684|Secondary|Fasting Lipids and Glucose|Fasting lipids include: total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and glucose. Fasting was set to be 8 hours prior to the sample collection.|Baseline and week 48|All eligible participants enrolled with lipids results available at a given time point.|||mg/dL||Inter-Quartile Range|Median
1310029|NCT02582684|Secondary|Number of HIV-1 Drug Resistance Mutation Occurrences in Participants|Number of HIV-1 drug resistance mutation occurrences participants with virologic failure and FDA snapshot non-successes. Participants that had one drug class resistance mutation may have one or more mutations.|at the time of virologic failure|Of the enrolled eligible participants, those with virologic failures had resistance testing done.|||number of mutation occurrences|||Number
1310030|NCT02582684|Secondary|Change in CD4+ Cell Count|Change in CD4+ cell counts by study week. Change was calculated as value at the later visit minus the value at baseline.|Baseline, weeks 4, 12, 24, and 48|All eligible participants enrolled with CD4 cell count results available at baseline and the given visit.|||cells/mm^3||Inter-Quartile Range|Median
1310031|NCT02582684|Secondary|CD4+ Cell Count|CD4+ cell counts by study week.|Baseline, weeks 4, 12, 24, and 48|All eligible participants enrolled with CD4 count results available at a given visit.|||cells/mm^3||Inter-Quartile Range|Median
1310032|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated|Proportion of participants with HIV-1 RNA < 200 copies/mL by week, as treated population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|As Treated: purely virologic missing=ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
1310033|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated|Proportion of participants with HIV-1 RNA < 50 copies/mL by week, as treated population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|As Treated: purely virologic missing = ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
1310034|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored|Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing = ignored) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
1310035|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored|Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (missing = ignored) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
1310036|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure|Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing/off study/off treatment = failure) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.|||proportion of participants||95% Confidence Interval|Number
1310037|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure|Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (Intention To Treat; missing/off study/off treatment = failure) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.|||proportion of participants||95% Confidence Interval|Number
1310038|NCT02582684|Secondary|Virologic Failure|"Virologic failure is defined as follows:~Weeks 16 or 20: confirmed plasma HIV-1 RNA > 400 copies/mL~Week 24 or later: confirmed plasma HIV-1 RNA > 200 copies/mL~Participants were evaluated for virologic failure regardless of whether on study treatment.~Confirmation was determined based on any two consecutive evaluations meeting the virologic failure definition regardless of the time between them.~Participants discontinuing the study (for any reason, including death and lost to follow-up) were considered virologic failures if their last measurement met the definition of virologic failure but no confirmatory measurement was obtained. All other participants’ follow-up was censored immediately after the last available plasma HIV-1 RNA measurement."|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|All eligible participants enrolled.|||Participants|||Count of Participants
1310039|NCT02582684|Secondary|Virologic Status at Week 48|"Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 48 Window are provided below.~Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition)."|At 48 weeks after study entry|All eligible participants enrolled.|||Participants|||Count of Participants
1310040|NCT02582684|Secondary|Virologic Status at Week 12|"Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 12 Window are provided below.~Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition)."|At 12 weeks after study entry|All eligible participants enrolled.|||Participants|||Count of Participants
1310042|NCT02582632|Other Pre-specified|Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|Baseline and 12 weeks after the last actual dose of study drug|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; participants with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
1310043|NCT02582632|Other Pre-specified|Percentage of Female Participants Responding With SVR12: mITT-GT Population|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; female participants. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
1310044|NCT02582632|Other Pre-specified|Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population|Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.|Up to 12 weeks after last dose of study drug|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1310045|NCT02582632|Other Pre-specified|Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population|On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.|Up to 8 weeks while on treatment|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection.|||percentage of participants||95% Confidence Interval|Number
1310046|NCT02582632|Other Pre-specified|Percentage of Participants Who Achieve SVR12: mITT-GT Population|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|The modified ITT (mITT)-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
1310047|NCT02582632|Secondary|Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|Baseline and 12 weeks after the last actual dose of study drug|ITT population: all enrolled participants who received at least 1 dose of study drug and with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
1310048|NCT02582632|Secondary|Percentage of Female Participants Responding With SVR12|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|ITT population: all enrolled female participants who received at least 1 dose of study drug. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
1310049|NCT02582632|Secondary|Percentage of Participants With Post-Treatment Relapse12|Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.|Up to 12 weeks after last dose of study drug|ITT population: all enrolled participants who received at least 1 dose of study drug. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1310061|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in 2-hour PPG at Individual Meal (Breakfast, Lunch and Main Evening Meal)|Change from baseline in 2-hour postprandial glucose (PPG) at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points.|||mmol/L||Standard Deviation|Mean
1310050|NCT02582632|Secondary|Percentage of Participants With On-Treatment Virologic Failure During Treatment Period|On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.|Up to 8 weeks while on treatment|ITT population: all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1310051|NCT02582632|Primary|Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
1310052|NCT02582242|Secondary|Change From Baseline in Patient-reported Treatment Satisfaction as Assessed by the Diabetes Treatment Satisfaction Questionnaire (Status) (DTSQs)|Change from baseline in patient-reported treatment satisfaction (as assessed by the DTSQs) was evaluated after 24 weeks of treatment. The DTSQs is a self-completion questionnaire used to investigate the subject’s treatment satisfaction. The DTSQ contained 8 questions, which were scored on a scale from 0 to 6. Out of 8 questions, 6 were related to the overall treatment satisfaction and 2 were related to glycaemic control (hypoglycaemia and hyperglycaemia). Results for the 6 questions relating to overall treatment satisfaction are presented together whereas the 2 questions relating to blood glucose are presented separately. For the overall treatment satisfaction, a higher score (0−36) was related to a better perception of treatment satisfaction. For hypoglycaemia and hyperglycaemia, a lower score (0−6) was related to a better blood glucose control. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Score on a scale||Full Range|Median
1310053|NCT02582242|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30).|||Kilogram (kg)||Standard Deviation|Mean
1310054|NCT02582242|Secondary|Total Daily Insulin Dose|Total daily insulin dose was the sum of doses given before breakfast and before main evening meal for the BID treatment group, and the sum of doses given before breakfast, before lunch and before main evening meal for the TID treatment group. Missing data was imputed using the LOCF method.|Week 1, Week 24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||Units (U)||Standard Deviation|Mean
1310055|NCT02582242|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|Incidence of TEAEs was recorded during 24 weeks of treatment. A TEAE was defined as an event that has onset date (or increase in severity) on or after the first day of exposure to trial product (in week 0) and no later than 7 days after the last day on trial product.|Week 0-24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Number analyzed = number of subjects with corresponding numbers of TEAEs.|||Number of adverse events|||Number
1310056|NCT02582242|Secondary|7-point SMPG Profiles: Fluctuation in the 7-point Profile|Fluctuation in the 7-point SMPG profile was evaluated after 24 weeks of treatment. Fluctuation in 7-point SMPG profile was the average absolute difference to the mean of the profile of the 7-point SMPG measurements accumulated over the profile. Missing data was imputed using the LOCF method.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
1310057|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in Mean of the 7-point Profile|Change from baseline in mean of the 7-point SMPG profiles was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Standard Deviation|Mean
1310058|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in Mean of PPG Increment Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal)|Change from baseline in mean of PPG increment at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||mmol/L||Standard Deviation|Mean
1310059|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in Mean of 2-hour PPG Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal)|Change from baseline in mean of 2-hour PPG at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Standard Deviation|Mean
1310060|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in PPG Increment at Individual Meal (Breakfast, Lunch and Main Evening Meal)|Change from baseline in PPG increment at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points.|||mmol/L||Standard Deviation|Mean
1310075|NCT02581475|Secondary|Adenomas Per Patient in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.||||adenomas per patient||Standard Deviation|Mean
1324430|NCT02203630|Secondary|Days Spent Out of the Hospital|Hospital free days|Up to 28 days||||days|||Number
1310062|NCT02582242|Secondary|7-point SMPG Profile|"7-point self-measured plasma glucose (SMPG) profiles was evaluated after 24 weeks of treatment.~Subjects were instructed to perform the following SMPG measurements:~Before breakfast.~120 minutes after the start of breakfast.~Before lunch.~120 minutes after the start of lunch.~Before main evening meal.~120 minutes after the start of main evening meal.~At bedtime. Missing data was imputed using the LOCF method."|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points.|||mmol/L||Standard Deviation|Mean
1310063|NCT02582242|Secondary|Change From Baseline in FPG by Central Laboratory Analysis|Change from baseline in fasting plasma glucose (FPG) by central laboratory analysis was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Standard Deviation|Mean
1310064|NCT02582242|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes Classified According to Novo Nordisk Definition|"Treatment emergent hypoglycaemic episodes were defined as the hypoglycaemic episodes, which occurred on or after the first day of trial product administration (in week 0), and no later than 7 days after the last day on trial product.~Novo Nordisk (NN) classification of hypoglycaemia:~Severe hypoglycaemia: According to the ADA classification.~Blood glucose (BG) confirmed hypoglycaemia: an episode that is BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe or BG confirmed hypoglycaemia: an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia."|Week 0-24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30).|||Count of hypoglycaemic episodes|||Number
1310065|NCT02582242|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition|"ADA classification of hypoglycaemia:~Severe:Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. PG concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration~Asymptomatic:Episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L~Documented symptomatic:Episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤3.9 mmol/L~Pseudo:Episode during which person with diabetes reports any of the typical symptoms of hypoglycaemia with measured PG concentration >3.9 mmol/L but approaching that level~Probable symptomatic:Episode during which symptoms of hypoglycaemia are not accompanied by PG determination but that was presumably caused by a PG concentration ≤3.9 mmol/L"|Week 0-24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Treatment emergent hypoglycaemic episodes were defined as the hypoglycaemic episodes, which occurred on or after the first day of trial product administration (in week 0), and no later than 7 days after the last day on trial product.|||Count of hypoglycaemic episodes|||Number
1310066|NCT02582242|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes (According to the Novo Nordisk Classification)|Percentage of subjects achieving HbA1c <7.0% (yes or no) without severe or BG confirmed hypoglycaemic episodes (according to the Novo Nordisk classification) was evaluated after 24 weeks of treatment. Severe or BG confirmed hypoglycaemia: an episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. PG concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of participants|||Number
1310067|NCT02582242|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes.|Percentage of subjects achieving HbA1c <7.0% (yes or no) without severe hypoglycaemic episodes was evaluated after 24 weeks of treatment. Severe hypoglycaemia: Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of participants|||Number
1310068|NCT02582242|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%|Percentage of subjects achieving HbA1c <7.0% (yes or no) was evaluated after 24 weeks of treatment.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of participants|||Number
1310069|NCT02582242|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c was evaluated after 24 weeks of treatment. Missing data was imputed using the last observation carried forward (LOCF) method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of HbA1c||Standard Deviation|Mean
1310070|NCT02581488|Post-Hoc|Incidence of Debridements During Treatment Period|Number of debridements performed during the treatment period by treatment group.|6 weeks||||occurences|||Number
1310071|NCT02581488|Other Pre-specified|Time to Closure for Ulcers Achieving Closure by End of Follow-up|Days to closure for ulcers that closed by end of follow-up period.|10 weeks||||days||Standard Deviation|Mean
1310072|NCT02581488|Other Pre-specified|Time to Closure for Ulcers Achieving Closure in Treatment Period|Days to closure for ulcers that closed by end of treatment period.|6 weeks||||days||Standard Deviation|Mean
1310073|NCT02581488|Secondary|Target Ulcer Infection Rates in Each Treatment Group During the Treatment Period as Determined by Investigator-reported Adverse Events||6 weeks||||Participants|||Count of Participants
1310074|NCT02581488|Primary|Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment.|Ulcer area was measured using the ARANZ Silhouette digital imaging and measurement device.|6 weeks||||percentage of change from baseline (cm2)||Standard Deviation|Mean
1324431|NCT02203630|Secondary|Hospital Days Not in ICU|ICU free days|Up to 28 days||||days|||Number
1310077|NCT02581475|Secondary|Withdrawal Time in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.||||minute||Standard Deviation|Mean
1310078|NCT02581475|Primary|Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.|Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.|During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.||||proportion of participants||95% Confidence Interval|Number
1310079|NCT02581410|Secondary|Number of Subjects With Any pIMDs|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From 30 days post last vaccination (Month 3) until study end at Month 14|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1310080|NCT02581410|Secondary|Number of Subjects With Any and Related SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.|From 30 days post last vaccination (Month 3) until study end at Month 14|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1310081|NCT02581410|Secondary|Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells|gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]), as determined by in vitro Intracellular Cytokine Staining (ICS).|At Months 0, 1, 3 and 14.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.|||CD4+ T-cells/million T-cells||Standard Deviation|Mean
1310082|NCT02581410|Secondary|Anti-gE Ab Concentrations|VZV gE IgG antibody concentrations were determined by ELISA. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Months 0, 1, 3 and 14.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.|||mIU/mL||95% Confidence Interval|Geometric Mean
1310083|NCT02581410|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1310084|NCT02581410|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.|From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1310085|NCT02581410|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) period after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1310086|NCT02581410|Primary|Number of Days With Solicited General Symptoms|Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Days||Inter-Quartile Range|Median
1310087|NCT02581410|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
1310088|NCT02581410|Primary|Number of Days With Solicited Local Symptoms|Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Days||Inter-Quartile Range|Median
1310099|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Country|Reference site was considered as Abroad and the tests were performed in a laboratory in Amsterdam, Netherlands. A total of 150 data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site) were collected.|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
1310089|NCT02581410|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
1310090|NCT02581410|Primary|Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations|Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.|One month after dose 2, at Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available at Month 3.|||mIU/mL||95% Confidence Interval|Geometric Mean
1310091|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population.|||kappa coefficient|||Number
1310092|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
1310093|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||kappa coefficient|||Number
1310094|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
1310095|NCT02580799|Secondary|Percentage of Participants With Different IHC Results|"The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it’s called “HER2 negative.” If the score is 2+, it's called borderline. A score of 3+ is called “HER2 positive.” Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells."|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
1310096|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Primary Antibody|The primary antibodies included; Biocabe EP 10454, Cerb B2 (SP3 clone), Her2 Neu (SP3) Cell marque, Neomarkers (thermo) cerb B2-Ab-17 and Thermo SP3.|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
1310097|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Antigen Retrieval|Fixation of tissue samples cross-link proteins and masks antigenic sites; antigen retrieval process was performed before IHC staining in order to reverse the masking of antigenic sites. Antigen retrieval process was performed in this study using the following solutions: 1 hour Cell Conditioning 1 (CC1), 30 minutes (min) CC1 mild, 64 min CC1, CC1 Ethylenediaminetetraacetic acid (EDTA) standard, and Cell Conditioning 2 (CC2) 30 min.|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
1310098|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Different Automated Slide Stainers|Different slide stainers like Ventana, Ventana Benchmark 4XT, Ventana Benchmark Ultra and Ventana Benchmark XT were used to report HER2 test results on data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site).|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
1310100|NCT02580799|Secondary|Percentage of Participants With Specified Density of Hormone Receptors|The specific density of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||percentage of participants|||Number
1310101|NCT02580799|Secondary|Percentage of Participants With Different Hormone Receptors|Presence of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||percentage of participants|||Number
1310102|NCT02580799|Secondary|Percentage of Participants With Pathological Grade|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular, Nuclear and Mitosis scoring pattern was discussed in outcome 11, each score was added to give a final total score ranging from 3-9. Tumors with 3, 4 or 5 points are classified as being of low malignancy or Grade I, those with 6 or 7 points of intermediate malignancy or Grade II, and those with 8 or 9 points of high malignancy or Grade III.|Up to 70 days|FAS population.|||percentage of participants|||Number
1310103|NCT02580799|Secondary|Percentage of Participants With Pathological Score|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular score (TS) 1: >75 percent (%) of tumor area forming tubular structures, TS 2: 10% to 75% of tumor area forming tubular structures, TS 3: <10% of tumor area forming tubular structures. Nuclear score (NS) 1: nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size, NS 2: cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape, NS 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. Mitosis score (MS) 1: ≤7 mitoses per 10 high power fields, MS 2: 8-14 mitoses per 10 high power fields and MS 3: ≥15 mitoses per 10 high power fields.|Up to 70 days|FAS population.|||percentage of participants|||Number
1310104|NCT02580799|Secondary|Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision|TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastasis (M). T1: tumor ≤20 millimeters (mm), T2: tumor >20 mm to ≤50 mm, T3: >50 mm and TX: tumor cannot be assessed. N0: no lymph node metastasis, N1: metastasis to ipsilateral level I, II axillary lymph nodes, N2: N1 metastasis that is clinically fixed/matted or in clinically detected ipsilateral internal mammary nodes, N3: metastases in ipsilateral infraclavicular lymph nodes, with/without level I, II axillary node involvement, or in clinically detected ipsilateral internal mammary lymph nodes and clinically evident level I, II axillary lymph node metastasis; or metastasis in ipsilateral supraclavicular lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastasis, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm, and MX: metastases cannot be assessed.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
1310105|NCT02580799|Secondary|Percentage of Participants With Diagnosis of Primary Tumor|Primary tumor diagnosis was classified into invasive ductal carcinoma, invasive ductal carcinoma + integrin linked kinase (ILK) antibody and mixed (invasive ductal + lobular) and reported.|Up to 70 days|FAS population.|||percentage of participants|||Number
1310106|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Site B and Others (Sites C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||kappa coefficient|||Number
1310107|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
1310108|NCT02580799|Primary|Kappa Coefficient (K) as a Measure of Agreement Between Site A and Others (Sites B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values were interpreted as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||kappa coefficient|||Number
1324432|NCT02203630|Secondary|Days Without Dialysis|Dialysis-free days|Up to 28 days||||days|||Number
1310109|NCT02580799|Primary|Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
1310110|NCT02580357|Other Pre-specified|Tissue Thickness|Through four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).|Before the procedure and 3 months after the procedure|||||||
1310111|NCT02580357|Secondary|Postoperative Discomfort|"After air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant no pain and 10 meant extreme pain. After this, a postoperative discomfort average for all groups was obtained."|7, 14, 45, and 60 days after surgical procedure||||units on a scale||Standard Deviation|Mean
1310112|NCT02580357|Primary|Change in the Remaining Wound Area (RWA)|For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).|7,14, 45 and 60 post operative days||||Square millimeters|Photographs|Standard Deviation|Mean
1310113|NCT02580318|Primary|Percent Alcohol Concentration Measured by Breathalyzer||20 minutes|number of participants that completed breath alcohol content are reported.|||percent Breathalyzed alcohol content||Standard Deviation|Mean
1310114|NCT02580240|Secondary|All Cause Mortality|Death from any cause at 90 days after the onset of septic shock|90 days||||Participants|||Count of Participants
1310115|NCT02580240|Primary|28-day Mortality|Death from any cause at 28 days after the onset of septic shock|28 days||||Participants|||Count of Participants
1310116|NCT02580188|Other Pre-specified|Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)|Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician. The amount of fentanyl used and additional analgesic drugs used are reported.|48hr after end of operation|||||||
1310117|NCT02580188|Other Pre-specified|Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)|Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician. The amount of fentanyl used and additional analgesic drugs used are reported.|24hr after end of operation|||||||
1310118|NCT02580188|Primary|Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg|"Intra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at < 15 mmHg.~Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line."|intraoperative, an averrage of 3 hour||||Participants|||Count of Participants
1310119|NCT02579772|Secondary|Change in Pulmonary Ventilation - Minute Ventilation (VE)|During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|end-exercise value (Day 4)||||liters/min||Standard Error|Mean
1310120|NCT02579772|Secondary|Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)|Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|Day 4||||seconds||Standard Error|Mean
1310121|NCT02579772|Secondary|Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)|Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|Day 4||||seconds||Standard Error|Mean
1310122|NCT02579772|Secondary|Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)|Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|Day 4||||seconds||Standard Error|Mean
1310123|NCT02579772|Secondary|Change in Central Cardiovascular Function - Cardiac Output|During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|end-exercise value (Day 4)||||liters/min||Standard Error|Mean
1310124|NCT02579772|Primary|Exercise Capacity - Time to Exhaustion|Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|end-exercise value (Day 4)||||seconds||Standard Error|Mean
1310125|NCT02579772|Primary|Plasma Redox Status - Circulating Glutathione|Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|pre-exercise value (day 4)||||micromolar||Standard Error|Mean
1310126|NCT02579603|Secondary|Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone|Predose plasma concentrations at steady state (Cpre,ss) of pirfenidone at Week 2 (Visit 4) and Week 4 (Visit 5)|Prior to intake of study medication on week 2 and week 4|PKS set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314909|NCT02434497|Secondary|Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline ApoA-1|participants|95% Confidence Interval|Geometric Mean
1310127|NCT02579603|Secondary|Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4|Predose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline (Visit 3), Week 2 (Visit 4) and Week 4 (Visit 5)|baseline, prior to intake of study medication on week 2 and week 4|Pharmacokinetic Set (PKS): This analysis set included all patients who had been treated with study medication and who provided evaluable data for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310128|NCT02579603|Primary|Percentage of Patients With On-treatment Gastrointestinal (GI) AEs (SOC GI Disorders) From Baseline to Week 12|"Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12.~On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive)."|Baseline to week 12|Treated set : The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment.|||percentage of participants|||Number
1310129|NCT02579057|Secondary|Urine Sodium|Total urinary sodium produced during the 6 hour urine collection|6-hour period||||mEq/L||Standard Deviation|Mean
1310130|NCT02579057|Secondary|Number of Participants With Side Effects|Cumulative total of pain, local skin reactions (including hematoma and induration) and electrolyte abnormalities.|Up to 6 hours||||Participants|||Count of Participants
1310131|NCT02579057|Secondary|Heart Failure Symptom Scoring/Symptom Improvement|Will evaluate if subjective heart failure symptoms improve over the period of diuresis. Measured by Kansas City Cardiomyopathy Questionnaire|6-hour period|Data was not collected on enough patients to accurately analyze this endpoint. No data analysis was performed for this outcome.||||||
1310132|NCT02579057|Primary|Urine Output|The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.|6-hour period||||mL||Standard Deviation|Mean
1310133|NCT02578992|Secondary|Visual Analog Scale of Sore Throat|"All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.~Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome."|after anesthesia emergence 30 minutest, at post-anesthesia care unit||||units on a scale||Full Range|Mean
1310134|NCT02578992|Secondary|Mean Arterial Pressure|compare the mean arterial pressure between two groups.|before and after intubation, up to 5 minutes||||mmHg||Standard Deviation|Mean
1310135|NCT02578992|Secondary|Modified Cormack–Lehane Grade|"The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.~Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome."|during intubation, after epiglottis was identified on the video monitor||||units on a scale||Full Range|Mean
1310136|NCT02578992|Primary|Intubation Time|the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.|from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts||||seconds||Inter-Quartile Range|Median
1310137|NCT02578706|Secondary|Change in Cholesterol Uptake by Monocytes|substudy|baseline and 24 weeks|data not collected||||||
1310138|NCT02578706|Secondary|Change in Thrombus Formation (High Shear) From Baseline to 24 Weeks|substudy - Change in thrombus formation by Badimon chamber (high shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. The high shear chambers (inner lumen diameter 0.1 mm, Reynolds number 60, shear rate 1690 s- 1) mimic the rheologic conditions of a moderately stenosed coronary artery.|baseline and 24 weeks||||μ(2)/mm||Standard Deviation|Mean
1310139|NCT02578706|Secondary|Change in Thrombus Formation (Low Shear) From Baseline to 24 Weeks|substudy - Change in thrombus formation by Badimon chamber (low shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. μ(2)/mm is the area of thrombus. The low shear chamber (inner lumen diameter 0.2 mm, Reynolds number 30, shear rate 500 s- 1) simulates flow conditions of a normal coronary artery.|baseline and 24 weeks||||μ(2)/mm||Standard Deviation|Mean
1310140|NCT02578706|Secondary|Change in Alpha Angle From Baseline to 24 Weeks|Alpha angle is measured using thromboelastography, measured by a tangent to the clotting curve through the 2mm point|baseline and 24 weeks||||degree||Standard Deviation|Mean
1310141|NCT02578706|Secondary|Change in Maximum Clot Firmness (MCF) From Baseline to 24 Weeks|Maximum Clot Firmness (MCF) is measured using thromboelastography. maximum ampliture in mm|baseline and 24 weeks||||mm||Standard Deviation|Mean
1310142|NCT02578706|Secondary|Change in Clot Formation Time (CFT) From Baseline to 24 Weeks|Clot formation time is measured using thromboelastography. time from 2 to 20 mm amplitude in seconds.|baseline and 24 weeks||||seconds||Standard Deviation|Mean
1310143|NCT02578706|Secondary|Change in Coagulation Time (CT) From Baseline to 24 Weeks|Clot formation kinetics, or coagulation time, is measured using thromboelastography. time to 2mm amplitude in seconds.|baseline and 24 weeks||||seconds||Standard Deviation|Mean
1310144|NCT02578706|Secondary|Change in Monocyte Platelet Aggregates From Baseline to 24 Weeks|Change in % platelet monocyte aggregates from baseline to week 24|baseline and 24 weeks||||% platelet monocyte aggregates||Standard Deviation|Mean
1310145|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to Arachidonic Acid 1500µM From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by arachidonic acid 1500µM from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
1310146|NCT02578706|Secondary|Change in Spontaneous Platelet Aggregometry From Baseline to Week 24|Change in spontaneous % platelet from baseline to week 24. Spontaneous platelet aggregation?|baseline and 24 weeks||||% platelet||Standard Deviation|Mean
1310147|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to Epi 5µM From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by light transmission aggregometry as measured by epinephrine 5µM from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
1310148|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to Collagen 2µg/mL From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by Collagen 2µg/mL from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
1310149|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to ADP 20µM From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by Adenosine Diphosphate (ADP) from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
1310150|NCT02578706|Secondary|Change in sCD40L From Baseline to Week 24|Soluble CD40-ligand levels|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
1310151|NCT02578706|Secondary|Change in sTNFR II From Baseline to Week 24|Soluble tumor necrosis factor receptor (sTNFR) serum concentration|baseline and 24 weeks||||pg/ml||Standard Deviation|Mean
1310152|NCT02578706|Secondary|Change in sTNFR I From Baseline to Week 24|Soluble tumor necrosis factor receptor (sTNFR) serum concentration|baseline and 24 weeks||||pg/ml||Standard Deviation|Mean
1310153|NCT02578706|Secondary|Change in D-dimer From Baseline to Week 24|D-Dimer level looks at coagulation of blood. D-dimers are not normally present in blood except when coagulation has occurred.|Baseline and 24 weeks||||mcg/L||Standard Deviation|Mean
1310154|NCT02578706|Secondary|Change in IL-6 From Baseline to Week 24|Interleukin 6 gene encodes a cytokine that functions in inflammation and implicated in a variety of inflammatory-associated disease states.|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
1310155|NCT02578706|Secondary|Change in Monocyte Activation sCD163 From Baseline to Week 24|Soluble CD163 is a specific macrophage activation marker, associated with morphological disease grade. A high sCD163 indicates more disease.|baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
1310156|NCT02578706|Secondary|Change in Non-classical Monocyte Subsets From Baseline to Week 24|The non-classical monocyte shows low level expression of CD14 and additional co-expression of the CD16 receptor (CD14+CD16++ monocyte).[|baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
1310157|NCT02578706|Secondary|Change in Intermediate Monocyte Subsets From Baseline to Week 24.|The intermediate monocyte with high level expression of CD14 and low level expression of CD16 (CD14++CD16+ monocytes).|Baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
1310158|NCT02578706|Secondary|Change in Classical Monocyte Subsets From Baseline to Week 24|The classical monocyte is characterized by high level expression of the CD14 cell surface receptor (CD14++ CD16− monocyte)|baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
1310159|NCT02578706|Secondary|Number of Subjects With at Least One Grade 3 or Higher Sign/Symptom or Laboratory Abnormality|Safety as measured by a Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality. A grade 3 sign/symptom was defined as medically significant but not immediately life threatening.|24 weeks||||Participants|||Count of Participants
1310160|NCT02578706|Primary|Change in sCD14 From Baseline to Week 24|Soluble CD14 (sCD14) levels in blood. sCD14 is a nonspecific maker of monocyte activation.|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
1310161|NCT02578316|Secondary|Objective Tumor Response|A response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) was assigned by the investigator as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR was defined as disappearance of all target lesions. Any pathological lymph node had to be reduced in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. PD was defined as a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment start or the appearance of one or more new lesions. CR or PR was confirmed no less than 4 weeks after first observation of the response. For SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. SD is defined as lasting at least 5 weeks.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to 1 year|The Response Evaluable Population is the group of participants who received at least a partial dose of study treatment who had measureable disease per RECIST at baseline.|||Percentage of participants|||Number
1310162|NCT02578316|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, blood chemistry, and urine values; results of physical examinations, regular measurement of vital sign measurements, and 12-lead electrocardiogram (ECG), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.|Date of first dose of study treatment till 30 days after the last dose, assessed up to 1 year|The Safety Analysis Set was the group of participants who received at least one partial dose of study drug and had at least one postdose safety assessment.|||Percentage of participants|||Number
1310163|NCT02578316|Primary|Percentage Recovery of 14^C- Lenvatinib Related Material in the Feces|Fecal samples were collected at specific time points, then analyzed for the amount of 14^C- lenvatinib related material. The percentage of the 14^C- lenvatinib dose excreted in feces (Aefeces%) was calculated from time of dosing to the last quantifiable measurement. If radioactivity levels were still present at the end of the Study Phase, sampling continued until each sample contained less than 1% of the total radioactive dose. Percentage recovery of 14^C- lenvatinib related material in the feces was summarized as the Geometric Mean (CV%) percent cumulative for all participants and expressed as percent of 14^C- lenvatinib.|Day 1 to Day 8|PK Analysis Set|||Percentage of 14^C-lenvatinib||Geometric Coefficient of Variation|Geometric Mean
1310164|NCT02578316|Primary|Percentage Recovery of 14^C- Lenvatinib Related Material in the Urine|Urine samples were collected at specific time points, then analyzed for the amount of 14^C- lenvatinib related material. The total radioactive dose of 14^C-lenvatinib excreted in urine (Aeurine%) was calculated from the time of dosing to the last quantifiable measurement. If radioactivity levels were still present at the end of the Study Phase, sampling continued until each sample contained less than 1% of the total radioactive dose. Percentage recovery of 14^C- lenvatinib related material in the urine was summarized as the Geometric Mean (CV%) percent cumulative for all participants and expressed as percent of 14^C- lenvatinib.|Pre-dose, post-dose at 0-6, 6-12, 12-18, 18-24, 24-30, 30-36, 36-42, 42-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours|PK Analysis Set|||Percentage of 14^C-lenvatinib||Geometric Coefficient of Variation|Geometric Mean
1310352|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants|4 weeks||||errors|||Number
1310165|NCT02578316|Primary|Renal Clearance of Lenvatinib (CLr)|CLr was determined based on the interval amount and cumulative amount of the analyte excreted in the urine divided by its corresponding AUC over the same collection interval. Aeurine(0-t)/AUC(0-t), where t is the last measurable concentration, was calculated for lenvatinib only and was summarized as the Geometric Mean (CV%) for all participants and expressed in L/hr.|Pre-dose, post-dose at 0-6, 6-12, 12-18, 18-24, 24-30, 30-36, 36-42, 42-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours|PK Analysis Set|||L/hour||Geometric Coefficient of Variation|Geometric Mean
1310166|NCT02578316|Primary|Apparent Terminal Volume of Distribution in the Terminal Phase of Lenvatinib (Vz/F)|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Vz/F for lenvatinib only was calculated as Dose/[(λz)·(AUC(0-inf))] and was summarized as the Geometric Mean (CV%) for all participants and expressed in liters (L).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||L||Geometric Coefficient of Variation|Geometric Mean
1310167|NCT02578316|Primary|Apparent Clearance (CL/F) of Lenvatinib From Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The CL/F for parent lenvatinib only was calculated as Dose/[AUC(0-inf)] and was summarized as the Geometric Mean (CV%) for all participants and expressed in L/hr.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||L/hour||Geometric Coefficient of Variation|Geometric Mean
1310168|NCT02578316|Primary|Percentage of Area Under the Plasma Concentration Curve Extrapolated to Infinity (%AUC(Extra))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. %AUC(extra) was calculated as [(AUC(0-inf) - AUC(0-t)/AUC(0-inf) ]*100 and was summarized as the Geometric Mean (CV%) for all participants and expressed in (ng·hr/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||Percent lenvatinib||Geometric Coefficient of Variation|Geometric Mean
1310169|NCT02578316|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC(0-inf))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The AUC(0-inf) was calculated as AUC(0-t) + Ct/λz where Ct is the last measurable concentration and was summarized as the Geometric Mean (CV%) for all participants and expressed in ng·hr/mL.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1310170|NCT02578316|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time t (AUC(0-t))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The AUC(0-t) was calculated by the combination of linear/log (from Tmax) trapezoidal rule where 't' is the time of last quantifiable plasma concentration following dosing. AUC(0-t) was summarized as the Geometric Mean (CV%) for all participants and expressed in nanograms·hour/milliliter (ng·hr/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1310171|NCT02578316|Primary|Terminal Exponential Half-life (t1/2) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib in Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The terminal phase t1/2 is the time required to divide the plasma concentration of study drug by two after reaching pseudo-equilibrium, and not the time required to eliminate half of the administered dose of study drug. The t1/2 during the apparent terminal disposition phase was calculated at 0.693/λz and was summarized as the Geometric Mean (CV%) for all participants and expressed as hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||Hours||Geometric Coefficient of Variation|Geometric Mean
1310172|NCT02578316|Primary|Terminal Phase Rate Constant (λz) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib in Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The terminal phase rate constant represents the rate at which study drug was eliminated from the body and was determined by log-linear regression of the plasma concentrations against time in the terminal phase and was summarized as the Geometric Mean (CV%) for all participants and expressed as 1/hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||1/hour||Geometric Coefficient of Variation|Geometric Mean
1310173|NCT02578316|Primary|Time of Maximum Plasma Concentration (Tmax) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Individual blood/plasma concentration-time data were analyzed using 'non-compartmental' analysis. Tmax was determined from visual inspection of the individual blood/plasma concentration-time profile and was summarized as the Geometric Mean (CV%) for all participants and expressed as hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||Hours||Geometric Coefficient of Variation|Geometric Mean
1310198|NCT02577107|Secondary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day)|Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after third injection at Visit 10 (Day 67 +/- 1 day). Blood sample was collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits.|Baseline, Visit 10 (Day 67 +/- 1 day)|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
1310174|NCT02578316|Primary|Maximum Plasma Concentration (Cmax) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Individual blood/plasma concentration-time data were analyzed using 'non-compartmental' analysis. Cmax was determined from visual inspection of the individual blood/plasma concentration-time profile and was summarized as the Geometric Mean and percent coefficient of variation for the Geometric Mean (CV%) for all participants and expressed as nanograms/milliliter (ng/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|The Pharmacokinetic (PK) Analysis Set is the group of participants who received the Study Phase dose of 14^C-lenvatinib and have any evaluable post 14^C- lenvatinib dose plasma and/or blood concentration data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310175|NCT02578199|Secondary|Body Weight in Pounds|Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).|6 months||||pounds||Standard Deviation|Mean
1310176|NCT02578199|Primary|Body Weight in Pounds|Body weight in pounds measured 3 months after starting treatment.|3 months|27 participants completed treatment, 28 participants completed the post treatment assessment (i.e., one participant who dropped from treatment completed the post treatment assessment).|||pounds||Standard Deviation|Mean
1310177|NCT02578186|Primary|Mean Latency to Persistent Sleep|Per Protocol population based on subjects who completed treatment crossover|4 weeks|Subjects with evaluable data for mean latency to persistent sleep for both treatment periods were included in the efficacy analysis provided they meet the other defined Per Protocol criteria. All data for each treatment and endpoint were averaged for all days in which the study medication was taken in a given treatment period.|||minutes||Standard Error|Mean
1310178|NCT02577718|Secondary|Incidence of Catheter-Associated Infections|Catheter-Associated Infections will be measured by microbiological culture defined as either Catheter-Related Bloodstream Infection (CRBSI) as defined by the Infectious Diseases Society of America (IDSA), particularly in neutropenic patients, or Central Line-Associated Bloodstream Infection (CLABSI) as defined by the Centers for Disease Control and Prevention (CDC), particularly in non-neutropenic patients|60 Days|619 catheter days on NiCE Lock Solution / 1853 catheter days off NiCE Lock Solution|||infections per 1000 catheter days|catheter days||Number
1310179|NCT02577718|Primary|Number of Participants With Drug-Related Hypotension|Drug-related hypotension is defined as a significant drop in measured blood pressure (BP) that exceeds the normal BP variability of a patient by 30%, that is associated with clinical signs and symptoms (dizziness and syncope) and is unexplained by factors other than the lock solution (such as other antihypertensive drugs, sepsis, bleeding). BP variability will be based on the standard deviation (SD) of a patient’s blood pressure measured in the 3 days preceding participation in this trial and will be calculated at the time of trial entry.|From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days|All patients receiving at least one dose|||Participants|||Count of Participants
1310180|NCT02577510|Secondary|Pain With Procedure|visual analogue scale- 0-10 - 0 is equal to no pain, while 10 is equal to maximum pain|less than 30 minutes||||units on a scale|sides|Standard Deviation|Mean
1310181|NCT02577510|Secondary|Needle Pass|how often needle changes angle to make target|less than 30 minutes||||attempts|sides|Standard Deviation|Mean
1310182|NCT02577510|Secondary|Success Rate|percentage of patients with successful block|less than 30 minutes||||Participants|||Count of Participants
1310183|NCT02577510|Primary|Anesthesia Related Time|The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times|less than 30 minutes||||seconds|sides|Standard Deviation|Mean
1310184|NCT02577445|Other Pre-specified|Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea|Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.|screening|||||||
1310185|NCT02577445|Secondary|Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea|Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system|Up to 2 years (collected until 6M FU)|No conclusion can be drawn on all-cause mortality and all-cause hospitalization rates for this group of patients;only 3 subjects diagnosed with CSA (not implanted) reached the 6M FU at the time of study termination. No deaths and/or hospitalizations had been reported in this subject group at the time of study termination.No 12M data is available.|||Participants|||Count of Participants
1310186|NCT02577445|Secondary|Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline|Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline|12 months post implant|No data available; no patient had completed a 12 months echo prior to the premature study stop||||||
1310187|NCT02577445|Secondary|Impact on Quality of Life Compared to Baseline|Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients|Up to 5 years post-implant|No data available on Quality of Life questionnaires; no patient completed the questionnaires at baseline AND at the 12M/24M follow-up at the time of premature study stop.||||||
1310188|NCT02577445|Secondary|Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline|Evaluate changes in sleep study results at 12 months compared to baseline|12 months post-implant|A complete dataset is only available for 1 patient and due to confidentiality reasons for this 1 patient we prefer not to present this data.||||||
1310189|NCT02577445|Primary|Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.|"Collect short and long term clinical data on safety of the remede system implanted in daily practice.~This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient."|From implant up to 5 years (collected until 24 month FU)|Viewing the limited amount of data at early study termination, the data should be interpreted with caution.|||Participants|||Count of Participants
1310353|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants|Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor|0 weeks (Visit 1)||||errors|||Number
1310190|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1310191|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1310192|NCT02577315|Primary|Maximum Measured Concentration of the Metformin in Plasma (Cmax)|Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310193|NCT02577315|Primary|Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)|Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1310194|NCT02577315|Primary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||nanogram (ng)*h /millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1310195|NCT02577315|Primary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from treated set (TS) who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Subject was included, even if he/she contributed only 1 PK value for one period.|||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
1310196|NCT02577107|Secondary|Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection|Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Baseline, Visit 7, 8, 9, 10, 11 after 3rd injection|Baseline, Visit 7, 8, 9, 10, 11|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
1310197|NCT02577107|Secondary|Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection|Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Baseline, Visit Visit 2, 3, 4, 5, 6 after 1st injection|Baseline, Visit 2, 3, 4, 5, 6|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
1310250|NCT02576145|Secondary|Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization|DTH skin reactions were assessed 48 hours after each KLH immunization given on Day 1 and on Day 29. A positive response was defined as an induration >=5 mm.|Day 1 and Day 29|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
1310199|NCT02577107|Primary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)|Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after first injection at Visit 5 (Day 8 +/- 1 day).Blood sample was collected for systemic VEGF. VEGF was measured by a blinded laboratory using ELISA kits.|Baseline, Visit 5 (Day 8 +/- 1 day)|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
1310200|NCT02577016|Secondary|Change From Baseline in FPG at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline FPG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of FPG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
1310201|NCT02577016|Secondary|Change From Baseline in Glucose Total Area Under the Plasma Concentration Curve From Hour 0 to Hour 2 (AUC0-2hr) After Meal at Week 24|Change from Baseline in Glucose Total AUC0-2hr after Meal at Week 24 is defined as Week 24 Glucose Total AUC0-2hr after a meal minus Week 0 Glucose Total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups.|Baseline and Week 24 (just before loading meal [0 min], 30 min, 60 min and 120 min)|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of glucose total AUC0-2hr after meal (baseline or post-baseline).|||mg･hr/dL||95% Confidence Interval|Least Squares Mean
1310202|NCT02577016|Secondary|Change From Baseline in 2-hr PMG at Week 24|Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of 2-hr PMG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
1310203|NCT02577016|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 24 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1310204|NCT02577016|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 26 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1310205|NCT02577016|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of HbA1c (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
1310206|NCT02577003|Secondary|Change From Baseline in Body Weight at Week 24|Change from baseline in body weight at Week 24 is defined as Week 24 body weight minus Week 0 body weight. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline body weight is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of body weight after meal (baseline or post-baseline).|||kg||95% Confidence Interval|Least Squares Mean
1310207|NCT02577003|Secondary|Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24|Change from baseline in glucose total AUC0-2hr after meal at Week 24 is defined as Week 24 glucose total AUC0-2hr after a meal minus Week 0 glucose total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups.|Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min)|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of glucose total AUC0-2hr after meal (baseline or post-baseline).|||mg･hr/dL||95% Confidence Interval|Least Squares Mean
1310208|NCT02577003|Secondary|Change From Baseline in 2-hr PMG at Week 24|Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of 2-hr PMG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
1310301|NCT02573467|Secondary|Number of Patients With Anti-BYM338 Antibodies|Investigated the development of immunogenicity against BYM338.|end of double-blind treatment (up to 8 months)|Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension. Only those participants who provided a sample were analyzed.|||Participants|||Number
1310209|NCT02577003|Secondary|Change From Baseline in FPG at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline FPG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of FPG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
1310210|NCT02577003|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 24 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1310211|NCT02577003|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 26 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1310212|NCT02577003|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of HbA1c (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
1310213|NCT02576938|Secondary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib|Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib|Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.|All participants who received at least 1 dose of study drug and provided at least 1 post-dose PK sample. PK sample was not collected for the placebo group.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1310214|NCT02576938|Secondary|Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant’s itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates.|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1310215|NCT02576938|Secondary|Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16|"The DLQI is a simple, participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “Not at all,” “A little,” A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of “Not relevant” which is scored as “0”. For all questions, if unanswered the question is scored as “0”. Totals range from 0 to 30 (less to more impairment). Changes from baseline in DLQI score were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates."|Baseline, Week 16|All participants who have received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1310216|NCT02576938|Secondary|Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16|The IGA consists of a 6-point severity scale to measure characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment. The scale ranges from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease).|Baseline, Week 16|All participants who received at least one dose of study drug and had IGA data at Week 16 .|||units on a scale||Standard Deviation|Mean
1310217|NCT02576938|Secondary|Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16|The SCORAD index uses the rule of nines to assess disease extent and evaluates five clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation and (5) lichenification. SCORAD also assesses subjective symptoms of pruritus and sleep loss with Visual Analogue Scales (VAS) where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These three aspects: extent of disease (A: 0-102), disease severity (B: 0-18) and subjective symptoms (C:0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103 where 0 = no disease and 103 = severe disease. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1310218|NCT02576938|Secondary|Percentage Change From Baseline in the EASI at Week 16|The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1314910|NCT02434497|Secondary|Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline ApoB|participants|95% Confidence Interval|Geometric Mean
1310219|NCT02576938|Secondary|Change From Baseline in the EASI at Week 16|The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Change from baseline were analyzed with a Mixed-effect Model Repeated Measure (MMRM) with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
1310220|NCT02576938|Primary|Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)|The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.|Week 16|All participants who received at least one dose of study drug and had EASI 50 data at Week 16.|||percentage of participants|||Number
1310221|NCT02576639|Secondary|Apparent Volume of Distribution (Vz/F)||Day 91|This PK parameter was not analyzed because data was not collected.||||||
1310222|NCT02576639|Secondary|Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)|CNP520 concentrations in plasma|Day 91|This PK parameter was not analyzed because data was not collected.||||||
1310223|NCT02576639|Secondary|Summary of CSF PK Concentrations|CSF samples were collected by lumbar puncture for assessment.|Days 1, 14, 28, 42, 56, 70 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
1310224|NCT02576639|Secondary|Summary of Plasma PK Parameter: Racc|Racc = the accumulation ratio . Blood samples were collected to assess Racc.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.|||ratio||Standard Deviation|Mean
1310225|NCT02576639|Secondary|Summary of PK Parameter: CLss/F|CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.|||mL/h||Standard Deviation|Mean
1310226|NCT02576639|Secondary|Summary of Plasma PK Parameter: T1/2|T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.|||hour||Standard Deviation|Mean
1310227|NCT02576639|Secondary|Summary of Plasma PK Parameter: Tlag|Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||hour||Full Range|Median
1310228|NCT02576639|Secondary|Summary of Plasma PK Parameter: Tmax|Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||hour||Full Range|Median
1310229|NCT02576639|Secondary|Summary of Plasma PK Parameter: AUCtau|AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||h*ng/mL||Standard Deviation|Mean
1310230|NCT02576639|Secondary|Summary of Plasma PK Parameter: Cmax|Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.|Days 1, 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
1310231|NCT02576639|Secondary|Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations|CSF samples were collected by lumbar puncture for assessment.|Day 92|The pharmacodynamics (PD) analysis set was analyzed. The PD set included only randomized participants who had available PD data and no protocol deviations with relevant impact on PD data.|||Percentage change||Standard Deviation|Mean
1310232|NCT02576639|Primary|Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths|Safety monitoring was conducted throughout the study.|13 weeks|The safety analysis set, which included participants who received at least 1 dose of study drug (CNP520 or placebo), was analyzed.|||Participants|||Number
1310249|NCT02576145|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to Month 12|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
1310233|NCT02576587|Secondary|Vascular Measures- Augmentation Index|"Augmentation Index (Alx) is an indication of systemic arterial stiffness and measures the contributions of wave reflection to central systolic pressure. Scores vary based on age and gender and in a normal, healthy population research has shown can range from -10% or less up to 50%. A negative augmentation index suggests low artery stiffness (late arriving wave reflections) and a positive index is a reflection of increase artery stiffness (reflective wave arriving early in the cardiac cycle). Waveforms will be processed using the SphygmoCor software (model EM3, version CvMS 9.0, Atcor Medical Pty, West Ryde, Australia) for this measurement.~It is calculated at the onset of reflected wave, Alx = AP/PP x 100. Alx = Augmentation Index, the percentage of the pulse pressure due to the AP; PP = Pulse Pressure; AP = Augmentation Pressure, the contribution of the reflected wave to the pulse pressure."|Baseline and 12 week follow up|Cases selected for follow-up and having available SphygmoCor measurements|||percentage of augmentation pressure||Standard Deviation|Mean
1310234|NCT02576587|Secondary|Vascular Measures- Pulse Wave Velocity|Radial measurements were performed on the same arm using the SphygmoCor device after sphygmomanometric pressure was obtained with use of an applanation tonometry probe containing a solid state high fidelity Millar transducer over the radial artery with a minimum of two consecutive measurements to obtain pulse wave analysis results. For pulse wave velocity, lead II ECG (LL, LA, RA) was performed along with cardotid and femoral applanation tomometry. Orientation and pressure applied to the transducer were adjusted to optimize applanation of the artery between the transducer and the underlying tissue. Waveforms were processed using the SphygmoCor software (model EM3, version CvMS 9.0, Atcor Medical Pty, West Ryde, Australia).)|Baseline and 12 week follow up|Cases selected for follow-up and having available SphygmoCor measurements|||m/s||Standard Deviation|Mean
1310235|NCT02576587|Secondary|Echocardiographic Measures- LA Systolic Strain by A2C View|Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber (A4C) and two-chamber (A2C) views are the most commonly used approaches to measure the strain rate (%) of left atrial.|Baseline and 12 week follow up||||percentage of left atrial volume||Inter-Quartile Range|Median
1310236|NCT02576587|Secondary|Echocardiographic Measures- LA Systolic Strain by A4C View|Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber (A4C) and two-chamber (A2C) views are the most commonly used approaches to measure the strain rate (%) of left atrial.|Baseline and 12 week follow up||||percentage of left atrial volume||Inter-Quartile Range|Median
1310237|NCT02576587|Secondary|Echocardiographic Measures- LA Volume Index|"Increased left atrial volume and strain are known risk factors of AF and PAF. Left atrial volume index (LAVI) is left atrial size indexed to Body surface area (BSA). The reference range of LAVI is 16-28 mL/m^2.~Mildly abnormal: 29-33 mL/m^2; Moderately abnormal: 34-39 mL/m^2; Severely abnormal: greater than or equal to 40 mL/m^2.~Echocardiography measurements were not available for some subjects due to image quality."|Baseline and 12 week follow up||||mL/m^2||Inter-Quartile Range|Median
1310238|NCT02576587|Secondary|Echocardiography Measures- Left Atrial Volume|Increased left atrial volume and strain are known risk factors of AF and PAF. Echocardiography measurements were not available for some subjects due to image quality.|Baseline and 12 week follow up|Cases found to have an apnea hypopnea index >=15 were asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine.|||mL||Inter-Quartile Range|Median
1310239|NCT02576587|Primary|Number of Participants With Paroxymal Atrial Fibrillation (PAF)|Patients with diagnosis of PAF were defined as cases. PAF is the primary outcome of baseline analysis, which aimed to quantify the association of sleep apnea and PAF.|Baseline|Cases and controls who had matched control/case were included in baseline analysis. Only 150 cases were one-to-one matched with controls.|||Participants|||Count of Participants
1310240|NCT02576535|Post-Hoc|Number of Participants Experiencing Seizures||10 years||||participants|||Number
1310241|NCT02576535|Primary|Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography||10 years||||participants|||Number
1310242|NCT02576535|Primary|Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)||10 years||||participants|||Number
1310243|NCT02576535|Primary|Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities||10 years||||participants|||Number
1310244|NCT02576535|Primary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms||10 years||||participants|||Number
1310245|NCT02576535|Secondary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms||10 years||||participants|||Number
1310246|NCT02576249|Secondary|Tegner Activity Level Scale|"The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.~A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport."|baseline (pre-injection), 2 weeks, 3 months||||units on a scale||Standard Deviation|Mean
1310247|NCT02576249|Secondary|Pain Scale Score|Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months.|Pre-injection, immediately post-injection, 2 weeks, 3 months||||units on a scale||Standard Deviation|Mean
1310248|NCT02576249|Primary|The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale|The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems.|3 months after the injection||||units on a scale||Standard Deviation|Mean
1310251|NCT02576145|Secondary|Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response|Nonresponders (participants who failed to mount antibody responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive antibody response to KLH was defined as at least a 2-fold increase in antibody concentration at any time point up to Day 252 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH Antibody nonresponders were evaluated.|||participants|||Number
1310252|NCT02576145|Secondary|Percentage of Participants With Positive Antibody Response to KLH Immunization at Month 6|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on Month 6 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA). Due to the small number of participants enrolled in the study, percentage of participants with positive antibody response to KLH immunization at Month 6 was not reported.|Month 6|||||||
1310253|NCT02576145|Secondary|Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+|Blood samples were obtained for flow activated cell sorter (FACS) analyses of HLA-DR+, CD45RO+ and CD45RA+ on Days 1, 29, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 29 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.Only participants with data available at a particular time point were analyzed.|||Percent expression||Standard Deviation|Mean
1310254|NCT02576145|Secondary|Mean Percent Expression of CD3, CD4, and CD8|Blood samples were obtained for flow activated cell sorter (FACS) analyses of T cell subsets (CD3, CD4, and CD8) on Days 1, 22, 29, 43, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 22, 29, 43 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.|||Percent expression||Standard Deviation|Mean
1310255|NCT02576145|Secondary|Mean Percent Expression of 2A3/CD25+ Antibody|CD25 is an antigen that is present on a subset of peripheral blood lymphocytes. The expression of CD25+ on T cell was investigated using antibody 2A3. Blood samples were drawn for evaluation of CD25+ at screening and on Days 29, 57, and 168.|Screening, Day 29, Day 57 and Day 168|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.|||Percent expression||Standard Deviation|Mean
1310256|NCT02576145|Secondary|Geometric Mean Antibody Concentrations for KLH (IgM and IgG) and TT (IgG)|Due to the small number of participants enrolled in the study, geometric means at Baseline and on Days 22, 29, 43 and 57 were not reported.|Screening, Day 22, Day 29, Day 43 and Day 57|||||||
1310257|NCT02576145|Secondary|Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response|Nonresponders (participants who mount humoral responses but no cellular responses to tetanus vaccination) were rechallenged with TT 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to TT was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, at any time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were tetanus cellular nonresponders were evaluated.|||participants|||Number
1310258|NCT02576145|Secondary|Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization|Nonresponders (participants who failed to mount cellular responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to KLH was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH cellular nonresponders were evaluated.|||participants|||Number
1310259|NCT02576145|Secondary|Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
1310260|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)|Positive cellular response was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
1310261|NCT02576145|Secondary|Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)|Humoral response to TT was defined as >=1.5 fold increase in antibody concentration from baseline in participants with protective anti-TT IgG level >=0.1 IU/mL. All humoral responses were assessed by ELISA.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
1324433|NCT02203630|Secondary|Number of Days Without Mechanical Ventilation|Mechanical ventilation-free days|Up to 28 days||||days|||Number
1310262|NCT02576145|Secondary|Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
1310263|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to KLH Immunization|Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43, and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
1310264|NCT02576145|Primary|Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 43 or Day 57|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses and had Day 43 and 57 assessments were included in this population.|||participants|||Number
1310265|NCT02576041|Secondary|Time to Reaction Evaluated During the F1 Simulator|During the test, at different times, the patient will be requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions will be registered.|7±3 days of active treatment|Adult outpatient of eighter sex affected by Allergic Rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).|||msec||Standard Deviation|Mean
1310266|NCT02576041|Secondary|Maintenance of Constant Speed Evaluated During the F1 Simulator|Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.|7±3 days of active treatment|The study included adult outpatient of either sex,affected by Allergic Rhinitis (seasonal or perennial) and/or Chronic Urticaria (induced or not induced),able to perform a preliminary driving test on F1-high speed simulator without experiencing signs or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness, etc).|||Km/h||Standard Deviation|Mean
1310267|NCT02576041|Primary|Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test|SDLP (mainly assessing attention capacities). This is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered.|7+3 days of active treatment|The study included adult outpatient of either sex affected by allergic rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).|||meters||Standard Deviation|Mean
1310268|NCT02575911|Secondary|Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op|Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available at the specified time point.|||percentage of eyes|Eyes||Number
1310269|NCT02575911|Secondary|Manifest Refraction Spherical Equivalent (MRSE)|The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.|Baseline, Month 1, Month 3 postoperative|This analysis population includes number of eyes in specified category.|||diopter|Eyes|Standard Deviation|Mean
1310270|NCT02575911|Secondary|Best Corrected Distance Visual Acuity (BCDVA) by Visit|BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.|Baseline, Month 1, Month 3 postoperative|This analysis population includes total number of eyes in specified category at visit.|||percentage of eyes|Eyes||Number
1310271|NCT02575911|Secondary|Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative|UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||percentage of eyes|Eyes||Number
1310272|NCT02575911|Secondary|Opaque Bubble Layer (OBL) at Day 0, Operative Day|Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set|||units on a scale|Eyes|Standard Deviation|Mean
1310273|NCT02575911|Secondary|Stromal Bed Quality at Day 0, Operative Day|Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set|||units on a scale|Eyes|Standard Deviation|Mean
1310274|NCT02575911|Secondary|Ease of Flap Dissection at Day 0, Operative Day|Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set|||units on a scale|Eyes|Standard Deviation|Mean
1324434|NCT02203630|Secondary|Number of Days Without Vasopressor Use|Shock free days|Up to 28 days||||days|||Number
1310275|NCT02575911|Secondary|Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative|Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||micrometers|Eyes|Standard Deviation|Mean
1310276|NCT02575911|Secondary|Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative|Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.|Month 1 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||micrometers|Eyes|Standard Deviation|Mean
1310277|NCT02575911|Primary|Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative|Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.|Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||micrometers|Eyes|Standard Deviation|Mean
1310278|NCT02575833|Secondary|Time to Onset of ≥ 1 mm ST-segment Depression|"Time to onset of ≥ 1 mm ST-segment depression was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.~Heart rate and rhythm were monitored during the exercise treadmill test by electrocardiography (ECG)."|Day 1|Participants who received study drug and completed the post-randomization exercise treadmill test.|||seconds||90% Confidence Interval|Median
1310279|NCT02575833|Secondary|Time to Onset of Exercise-induced Angina|Time to onset of angina was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.|Day 1|Participants who received study drug and completed the post-randomization exercise treadmill test|||seconds||90% Confidence Interval|Median
1310280|NCT02575833|Primary|Change From Baseline in Total Exercise Time|"Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol.~The Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes."|Baseline and day 1, after dosing|Participants who received study drug and completed the baseline and post-randomization exercise treadmill tests|||seconds||Standard Error|Least Squares Mean
1310281|NCT02574858|Primary|Number of Subjects With Abnormal EKG|Review of EKG for abnormalities after intervention with QRH-882260. Paired EKGs will be reviewed for electrical changes post QRH-882260 ingestion.|30 minutes||||Participants|||Count of Participants
1310282|NCT02574858|Primary|Number of Subjects With Abnormal Lab Values|Review of laboratory values for abnormalities after intervention with QRH-882260. If the first post-procedure labs are outside normal range, they must be within 20% of the subject’s baseline lab values or returning towards normal range. Lab values not meeting these criteria must be repeated weekly until they peak and weekly until normal or within 20% of baseline level or within normal range.|48 hours||||Participants|||Count of Participants
1310283|NCT02574845|Secondary|Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞)|This outcome measure presents area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1310284|NCT02574845|Primary|Maximum Concentration of Rosuvastatin (Cmax)|This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1310285|NCT02574845|Primary|Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)|This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|The pharmacokinetic (PK) parameter set (PKS) includes all randomised subjects who took at least one dose of study medication and provided at least one primary or secondary PK parameter that was not excluded from analysis due to non-evaluability or protocol violation relevant for the evaluation of the pharmacokinetics.|||nanomol (nmol) * hour (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
1310286|NCT02574832|Primary|Time to T 10 Level|Elapsed time in minutes to achieve T 10 level of anesthesia. Assessed by the anesthesia care provider using crushed ice. T 10 level is numbness up to the level of the belly button.|20 minutes after drug administration||||Minutes||Full Range|Mean
1310287|NCT02574260|Secondary|Number of Participants Alive at the Time of Study Discontinuation or Completion||At end of study, median duration of treatment was 267 days||||participants|||Number
1310302|NCT02573467|Secondary|Change in Muscles of the Thigh|Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.|up to 1 year, up to 2 years|No participants were analyzed. The optional MRI assessment was not initiated as the study was stopped.||||||
1310497|NCT02567188|Primary|Mean Hb Value at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
1310288|NCT02574260|Secondary|Number of Participants With an Objective Response|"Objective response is defined as participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST).~Responses must have been confirmed two visits not less than 4 weeks apart.~Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:~Complete response (CR): zero tumor burden~Partial response (PR): a 30% or greater decrease in tumor burden~Progressive disease (PD): a 20% or greater increase in tumor burden~Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|Every 12 weeks from the start of therapy in this extension protocol, or 12 weeks from the last assessment in the 002/03 protocol (whichever date is later) through 30 days after administration of the last dose; median duration of treatment was 267 days.||||participants|||Number
1310289|NCT02574260|Primary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).~Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From the first dose of talimogene laherparepvec in Study 002-03-E and within 30 days of the last dose; median duration of treatment was 267 days.||||participants|||Number
1310290|NCT02574247|Post-Hoc|Association Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception Tasks|Partial Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and slope of the psychometric function (in decibel per decibel) of untrained speech tasks (Coordinate Response Measure -- CRM; Institute of Electrical and Electronics Engineers -- IEEE) obtained from performance across two signal-to-noise ratios. Age and high-frequency pure-tone average were controlled for in this post-hoc analysis. Results obtained at first study visit.|Baseline (First study visit - 3 hour session)|In order to increase statistical power, the baseline results for medial olivocochlear reflex inhibition results and speech perception from the Training, Control, and Speech Groups were pooled for this analysis.|||Spearman partial rank correlation|||Number
1310291|NCT02574247|Secondary|Change in Auditory Training Phoneme Task Performance|Difference in signal-to-noise ratio (in decibels) on auditory training phoneme tasks (onsets, nuclei, and codas), computed between first and last measurement.|First and last measurements (baseline and last session up to a year later)|Due to the small sample size, statistical analyses of group data were not performed. Data were not collected in the Control or Speech groups.|||Signal-to-noise ratio change in decibels||Full Range|Median
1310292|NCT02574247|Secondary|Change in Auditory Training Sentence Task Performance|Difference in percent correct of auditory training sentences, computed between first and last measurements.|First and last measurements (baseline and last session up to a year later)|Due to the small sample size, statistical analyses of group data were not performed. Data were not collected in the Control or Speech groups.|||Difference in percentage correct||Full Range|Median
1310293|NCT02574247|Primary|Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks|Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and performance (in percent correct) on Coordinate Response Measure (CRM) task and Institute of Electrical and Electronics Engineers (IEEE) sentences, each presented at two decibel signal-to-noise ratios (dB SNR). Results obtained at first study visit.|Baseline (First study visit - 3 hour session)|In order to increase statistical power, the baseline results for medial olivocochlear reflex inhibition results and speech perception from the Training, Control, and Speech Groups were pooled for this analysis|||Spearman Rank Correlation Coefficient|||Number
1310294|NCT02574247|Primary|Change in Magnitude of Medial Olivocochlear Reflex Inhibition|Decibel difference in medial olivocochlear reflex inhibition computed between final visit and baseline visit, where medial olivocochlear reflex inhibition is quantified as amplitude difference (in decibels) between transient-evoked otoacoustic emissions obtained with versus without broadband noise presented to the contralateral ear.|First and last measurements (baseline and last session up to a year later)|Due to the small sample size in each group, statistical comparisons between groups were not performed. Data were not collected in the Speech Group.|||decibel difference||Full Range|Median
1310295|NCT02573948|Secondary|HIV Incidence|HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.|52 weeks|HIV negative cohort participants with HCV test result available at W24 a/or W52|||infections per 100 person years||2.5% Confidence Interval|Number
1310296|NCT02573948|Secondary|Incidence of HCV Infection|The HCV incidence was calculated by 100person/year|52 weeks|HCV negative cohort participants with HCV test result available at W24 a/or W52|||infections per 100 person year||95% Confidence Interval|Number
1310297|NCT02573948|Secondary|HIV Seroconversion|Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.|52 weeks|HIV negative cohort participants with HIV test result available at W24 and/or W52.|||Participants|||Count of Participants
1310298|NCT02573948|Secondary|HCV Seroconversion|Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period|52 weeks|HCV negative cohort participants with HCV test result available at W24 and/or W52.|||Participants|||Count of Participants
1310299|NCT02573948|Primary|Number of Cohort Participants Attending the Last Follow-up Visit at W52|Number of participants who were followed up and not lost to follow-up after enrolment into cohort.|52 weeks|Participants were invited to follow-up visits at W4, W12, W24 and W52|||Participants|||Count of Participants
1310300|NCT02573870|Primary|Change From Baseline in 0 to 4 Hours Post-dose Weighted Mean Heart Rate at Day 42, Derived From Electrocardiograms (ECGs)|ECG measurements were taken in supine position after obtaining vital signs. Weighted mean was derived by calculating the area under the curve (AUC), and then dividing by the relevant time interval. Baseline was the pre-dose measurement on Day 1. Change from Baseline in 0 to 4 hours post-dose weighted mean heart rate was measured on Days 1, 28 and 42 and was analyzed using a mixed models repeated measures (MMRM) model. Intent-To-Treat (ITT) Population: all randomized participants who received at least one dose of study medication.|Baseline and Day 42|ITT Population|||Beats per minute (bpm)||Standard Error|Least Squares Mean
1310303|NCT02573467|Secondary|Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score|The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, week 52, week 78, week 104 and >=week 117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||score on a scale||Standard Deviation|Mean
1310304|NCT02573467|Secondary|Estimated Annual Number of Falls Per Participant Within Treatment Group|Participants documented any fall occurrences in a paper diary during the study.|Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)|Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension.|||Annual number of falls per participant|||Number
1310305|NCT02573467|Secondary|Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score|Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, week 52, week 78, week 104, and >=week 117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||score on a scale||Standard Deviation|Mean
1310306|NCT02573467|Secondary|Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side|Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was performed using the same portable fixed dynamometry (PFD) used in the core study. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, week 52, week 78, week 104 and >=week 117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||newtons||Standard Deviation|Mean
1310307|NCT02573467|Primary|Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)|The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, weeks 52, 78, 104, and >=117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||meters||Standard Deviation|Mean
1310308|NCT02573467|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.|Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.|to end of study (up to 14 months, including the 6-month treatment-free follow-up period)|Safety set: The safety set consisted of all participants who received at least one dose of study drug during the extension study.|||Participants|||Number
1310309|NCT02572752|Secondary|AUC0-inf|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1310310|NCT02572752|Primary|Cmax|Maximum measured concentration of the analyte in plasma (Cmax). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310311|NCT02572752|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference treatment 1 (R1) and Reference treatment 2 (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|Pharmacokinetic Set (PKS) : This analysis set included all treated subjects who provided at least 1 observation for at least 1 primary endpoint, and who had no important protocol violations impacting statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1310312|NCT02572609|Primary|AUC0-t|Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ).|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|PK set|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1310313|NCT02572609|Primary|Cmax|Maximum plasma concentration achieved|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|The pharmacokinetic set (PK Set): 36 subjects provided 1 evaluable value of reference product and 1 evaluable value of test product for the primary PK endpoints (Cmax and AUC0-t) without important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310314|NCT02572427|Secondary|Knowledge Concerning Intubation of Neonates|Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).|30 minutes||||scores on a scale||Standard Deviation|Mean
1310315|NCT02572427|Primary|Skill in Intubating Neonatal Manikin|Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab|Up to two minutes||||seconds||Standard Deviation|Mean
1310316|NCT02572076|Primary|Evaluation of Per Patients Adequate Cleaning Level After the Use of MCS|cleansing level was evaluated based on Boston Bowel Preparation Scale( BBPS) , subject consider as having adequate cleaning if BBPS>1 in all colon segments|Within 24 hours- During the colonoscopy procedure||||Participants|||Count of Participants
1310317|NCT02571634|Secondary|Sedation Level Assessed by POSS Tool|At baseline, 15 minutes post medication receipt, 30 minutes , 45 minutes and at discharge a Pasero-Opioid Sedation Scale Score was obtained. This scale is to measure alertness and amount of sedation. POSS was the abbreviated term used for this scale. The guidelines for that scale include: S= sleeping easily aroused 1= alert and awake; 2= slightly drowsy easily aroused; 3= frequently drowsy, drifts off to sleep during conversation; 4= somnolent, minimal or no response|Baseline, 15 min, 30 min, 45 min, discharge||||POSS sedation scores||Standard Error|Mean
1310318|NCT02571634|Secondary|Adverse Events|Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.|24 hours|All 23 subjects were monitored with blood pressure, heart rate, oxygen saturation and sedation scores to determine any adverse events.|||number of adverse events|||Number
1310319|NCT02571634|Secondary|Patient Satisfaction Using a Likert Satisfaction Survey|At 24 hour after the procedure a call was made asking the volunteer to provide a number on a scale to describe their satisfaction with their pain control and their overall satisfaction. A 5 point likert scale was used 1 = very satisfied, 2 satisfied, 3 neither satisfied nor dis-satisfied, 4 not satisfied and 5 very unsatisfied.|24 hours|Subjects were asked about pain control satisfaction and overall satisfaction using a 5 point likert scale. 1 = very satisfied, 2= satisfied, 3= neither satisfied nor dis-satisfied, 4= not satisfied and 5 = very unsatisfied|||Units on scale||Standard Deviation|Mean
1310320|NCT02571634|Secondary|Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.|DVPRS pain scores will be recorded baseline and at 15 minutes post dosing, 30 minutes, 45 minutes and discharge. The DVPRS is a pain scale utilizing color coding descriptive terms and faces to describe pain levels from 0 meaning no pain and 10 the most excruciating pain ever.|Baseline, 15 min, 30 min, 45 min, and discharge||||pain score||Standard Error|Mean
1310321|NCT02571634|Primary|Safety and Tolerability as Measured by the Number of Adverse Events|Adverse events will be recorded by a yes or no as to their occurence|24 hours||||adverse events|||Number
1310322|NCT02571439|Other Pre-specified|Itching.|Itching will be assessed postoperatively on a scale of 0 to 10 at 24 hours after surgery. The minimum value was 0 for no itching and maximum value was 10 for severe itching. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing itching.|up to 24 hours after surgery||||scale of 0-10||Inter-Quartile Range|Median
1310323|NCT02571439|Other Pre-specified|Number of Participants With Postoperative Nausea/Vomiting|"outcomes will be assessed postoperatively as number of patients with postoperative nausea/vomiting present or not present at 24 hours after surgery"|up to 24 hours after surgery||||Participants|||Count of Participants
1310324|NCT02571439|Other Pre-specified|Sedation|sedation will be assessed postoperatively on a scale of 0 to 10. The minimum value was 0 for not sedated or awake and maximum value was 10 for extremely sedated. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing sedation.|up to 24 hours after surgery||||scale of 0-10||Inter-Quartile Range|Median
1310325|NCT02571439|Other Pre-specified|Total Narcotic Consumption|Total narcotic consumption, measured in mg of morphine 24 hours after surgery|24 hours after surgery||||mg of morphine||Inter-Quartile Range|Median
1310326|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 48 hours after surgery.|48 hours after surgery||||Units on a scale||Inter-Quartile Range|Median
1310327|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 24 hours after surgery. v|24 hours after surgery||||Units on a scale||Inter-Quartile Range|Median
1310328|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 8 hours after surgery. v|8 hours after surgery||||Units on a scale||Inter-Quartile Range|Median
1310329|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 4 hours after surgery. visual analog pain scale is a response scale to measure pain with a score of 0 representing no pain and a score of 10 representing the worst pain imaginable. The minimum value was 0 for no pain and maximum value was 10 for the worst pain imaginable. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing pain.|4 hours after surgery||||Numerical rating scale for pain||Inter-Quartile Range|Median
1310347|NCT02570425|Secondary|Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score|0 weeks (Visit 1)||||percent of participants|||Number
1310348|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants||8 weeks||||errors|||Number
1310330|NCT02571439|Secondary|Time From Delivery of Neonate to Ready to Exit Operating Room|Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.|Time measures will be recorded in the operating room, upto 6 hours||||minutes||Standard Deviation|Mean
1310331|NCT02571439|Primary|Time Taken to Perform the Block|Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.|The time taken to perform the block in the operating room is measured, upto 60 minutes||||minutes||Standard Deviation|Mean
1310332|NCT02571244|Secondary|Carbon Monoxide Verified Smoking Abstinence|Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6.|At third-month follow up|Intention to Treat Analysis|||Participants|||Count of Participants
1310333|NCT02571244|Secondary|Self Reported Smoking Abstinence|No smoking (even a puff) in the past 7 days at the third month after randomization.|Smoking abstinence at the third month after randomization|The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate, at 3-month assessment, was assessed as a secondary outcome.|||Participants|||Count of Participants
1310334|NCT02571244|Secondary|Self Reported Seek for Specialized Tobacco Treatment|self reported seek for specialized tobacco treatment after hospitalization|at the third month after randomization|It was included only patients that were able to be contacted for follow up (per protocol analysis).|||Participants|||Count of Participants
1310335|NCT02571244|Secondary|Daily Cigarettes Consumption at 3 Months Among Continuing Smokers|The experimental group self reported daily cigarettes consumption at the third month after randomization with be compared to the control group.|At the third month after randomization|It was included only patients that were able to be contacted for follow up (per protocol analysis).|||Number of cigarettes smoked per day||Standard Deviation|Mean
1310336|NCT02571244|Primary|Self Reported Smoking Abstinence|No smoking (even a puff) in the past 7 days at the first month follow up.|Smoking abstinence at the first month after randomization|The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate was assessed as the first outcome (1-month assessment).|||Participants|||Count of Participants
1310337|NCT02571153|Secondary|Percentage of Participants With Tramadol Consumption|Percentage of Participants with Tramadol during the ward stay|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||percentage of participants|||Number
1310338|NCT02571153|Secondary|The Severity of Postoperative Pain|"The severity of postoperative pain was rated the higher score of pain (NRS) during the hospital ward stay.~Pain was evaluated using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain."|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||units on a scale||80% Confidence Interval|Mean
1310339|NCT02571153|Secondary|Morphine Consumption (mg) at PACU|Morphine consumption (mg) at PACU (about 90 to 120 minutes)|During the stay at postanesthesia recovery room (about 90 to 120 minutes)|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||mg||80% Confidence Interval|Mean
1310340|NCT02571153|Secondary|Occurrence of Pain at PACU Using a 0-10 Numeric Pain Rating Scale|Occurrence of pain at the PACU. Average Pain will be calculated. The pain score will be evaluated using a 0-10 numeric pain rating scale, where zero mean no pain and 10 the worst imaginable pain.|90 minutes postanesthesia at recovery room|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||units on a scale||80% Confidence Interval|Mean
1310341|NCT02571153|Secondary|Occurrence of Postoperative, Nausea and Vomiting|Percentage of participants with postoperative nausea and vomiting at the PACU and during the hospital ward stay|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||percentage of participants|||Number
1310342|NCT02571153|Secondary|Length of PACU Stay|Length of stay at postanesthesia recovery room|During the stay at postanesthesia recovery room (about 90 to 120 minutes)|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||minutes||80% Confidence Interval|Mean
1310343|NCT02571153|Primary|Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery|Quality of postoperative functional recovery assessed by the questionnaire QoR40 The quality of postoperative functional recovery was assessed by the QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort – 12 items; emotional state – 7 items; physical independence – 5 items; physiological support - 7 items; and pain – 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). The QoR-40 was administered by a blind investigator 24 hours after surgery.|24 hours|Total of 152 patients were first assessed for eligibility in this study; however, 17 were excluded because they refused participation, or met any of the exclusion criteria. Thus, 135 participants were randomly allocated to the study groups. Later, 6 participants in group S, 8 in group K2, and 2 in group K4 were excluded due to protocol deviations.|||units on a scale||80% Confidence Interval|Mean
1310344|NCT02571049|Primary|The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment||60 minutes post-treatment||||Percentage of responders|||Number
1310345|NCT02570425|Secondary|Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score|8 weeks||||percent of participants|||Number
1310346|NCT02570425|Secondary|Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score|4 weeks||||percent of participants|||Number
1310354|NCT02570425|Secondary|The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor|Number of levels required to achieve device mastery out of a 6 level training processrequired by each patient at each visit as assessed by expert assessor|4 weeks||||levels||Standard Deviation|Mean
1310355|NCT02570425|Secondary|Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 8 weeks from baseline visit as assessed by expert assessor|8 weeks||||participants|||Number
1310356|NCT02570425|Secondary|Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 4 weeks from baseline visit as assessed by expert assessor|0 weeks (Visit 1)||||participants|||Number
1310357|NCT02570425|Secondary|Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process at baseline visit as assessed by expert assessor|0 weeks (Visit 1)||||participants|||Number
1310358|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks||||percent of participants|||Number
1310359|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks||||percent of participants|||Number
1310360|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks||||percent of participants|||Number
1310361|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks||||percent of participants|||Number
1310362|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)||||percent of participants|||Number
1310363|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)||||percent of participants|||Number
1310364|NCT02570425|Primary|Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor|"Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices.~The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar’s test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate."|4 weeks||||percent of participants|||Number
1310365|NCT02570295|Other Pre-specified|Daily Distance Covered on Foot|Daily distance covered on foot was measured using two accelerometers and one heart rate sensor. Data from weeks 2-9 of the basic military were combined and a single value (mean) was calculated for each group.|Weeks 2 - 9 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only an exemplary sample of 40 participants per group were chosen to wear the sensors due to financial reasons.|||km per day||Standard Deviation|Mean
1310498|NCT02567188|Primary|Mean Hb Value at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
1310366|NCT02570295|Other Pre-specified|Daily Energy Expenditure|Daily energy expenditure was measured using two accelerometers and one heart rate sensor. Data from weeks 2-9 of the basic military were combined and a single value (mean) was calculated for each group.|Weeks 2 - 9 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only an exemplary sample of 40 participants per group were chosen to wear the sensors due to financial reasons.|||Megajoule per day||Standard Deviation|Mean
1310367|NCT02570295|Other Pre-specified|Questionnaire About Sport Lessons|Duration of each sport session was registered in a questionnaire by the military personnel. The minimum would be 0 minutes of sport per week, for the maximum the scale is open-ended. Data of sport lessons during the whole basic military are combined and presented as a mean value for each group.|During the whole basic military training (18 weeks)||||minutes of sport per week||Standard Deviation|Mean
1310368|NCT02570295|Secondary|Attrition Rate|Withdrawals from the military service are reported by the training school's secretariat|During the whole basic military training (18 weeks)||||participants|||Number
1310369|NCT02570295|Secondary|Questionnaire About Health and Physical Activities||Week 1 of the basic military training and 3 months after finishing the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who completed the questionnaire at both time points were included in the analysis.|||Minutes of physical activity per week||Standard Deviation|Mean
1310370|NCT02570295|Secondary|Military Performance According to Military Marks|Military marks are given by superior Army personnel. The total score ranges from 1 (insufficient) to 5 (excellent). In total, three marks are given during the whole basic military training (after 7, 11 and 16 weeks). Data from those three time points are combined in a single value (mean).|During the basic military training (18 weeks)|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants from whom military marks were available for the whole basic military training were included in the analysis.|||units on a scale 1-5||Standard Deviation|Mean
1310371|NCT02570295|Secondary|Psychological Questionnaires|2 questionaires concerning resilience were used: The Resilience Scale 11 (Schumacher, Leppert, Gunzelmann, Strauss & Brähler, 2005) and the Brief Resilience Scale (Smith, Dalen, Wiggings, Tooley, Christopher & Bernard, 2008). A mean was calculated for each time point. The total score ranges from 1 (worst result) to 7 (best result).|Weeks 2, 10 and 16 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who the psychological questionnaires at all three time points were included in the analysis.|||units on a scale 1-7||Standard Deviation|Mean
1310372|NCT02570295|Secondary|Physical Fitness Measured With the Swiss Physical Fitness Test Battery (SPFTB)|"Physical Fitness is measured with the Swiss physical fitness test battery (SPFTB).~The SPFTB contains a progressive endurance run, a trunk muscle strength test, a standing long jump, a seated shot put, and a one-leg standing test. From the results of those performance tests (0 to 25 points each), a total fitness score is calculated (sum of all points). The minimum total score (worst result) is 0 points, the maximum total score (best result) is 125 points. A detailed description of the SPFTB can be found in the publication of Wyss, Marti, Rossi, Kohler and Mäder (2007)."|Weeks 2, 10 and 16 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who completed all three fitness tests were included in the analysis.|||units on a scale from 0 to 125||Standard Deviation|Mean
1310373|NCT02570295|Primary|Number of Participants With Injuries|All injuries which are registered in the patient's medical record are collected and classified. A classification system which takes into account anatomical site, circumstances of the accident, and severity of the injury is used.|During the basic military training (18 weeks)|The overall number of participants analyzed is smaller than the corresponding numbers in the participant flow module, because only participants who finished the whole 18-weeks basic military training were included in the analysis.|||participants with injuries|||Number
1310374|NCT02570165|Secondary|Change From Baseline in Trough FEV1 at Day 42|Trough FEV1 at Day 42 is the mean volume of air that can be forced out in one second after taking a deep breath at the approximately 23 Hrs and 24 Hrs assessments after the last administration of study drug. Batefenterol dose for each individual was compared with placebo or UMEC/VI. Change from Baseline was calculated as trough FEV1 on Day 42 minus baseline, where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The Maximum Likelihood Estimation (MLE) method of dose response modeling with Emax modeling without Bayesian priors was used. Participants with FEV1 values available at Baseline and Day 42 after 24 hrs after the last administration of study drug were analyzed.|Baseline and Day 42|ITT Population|||mL||Standard Error|Mean
1310375|NCT02570165|Primary|Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42|FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividing it by the 6-hour time interval. Batefenterol dose for each individual was compared with placebo or UMEC/VI. The change from Baseline in FEV1 was statistically analyzed using Bayesian Emax modeling of the dose response curve. Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment and who received at least one dose of study medication. Participants with FEV1 values available at Baseline and Day 42 were analyzed.|Baseline and Day 42|ITT Population.|||Milliliters (mL)||Standard Error|Mean
1310376|NCT02570126|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination|From Day 0 through the end of study (Day 84)||||Subjects|||Number
1310499|NCT02567188|Primary|Mean Hb Value at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
1310377|NCT02570126|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the administered dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
1310378|NCT02570126|Secondary|Number of Subjects Reporting Febrile Convulsions|Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
1310379|NCT02570126|Secondary|Number of Subjects Reporting Rash|Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
1310380|NCT02570126|Secondary|Number of Subjects Reporting Fever|Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature > 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
1310381|NCT02570126|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (>) 20 mm|4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 4 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
1310382|NCT02570126|Secondary|Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)|For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (< ) 25 mIU/mL) before vaccination|At Day 42 and Day 84 post vaccination|Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Seropositivity was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84|||Subjects|||Number
1310383|NCT02570126|Secondary|Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort)|Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)|At Day 42 and Day 84 post vaccination|Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Immune response (in terms of GMC) was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84|||mIU/mL||95% Confidence Interval|Geometric Mean
1310384|NCT02570126|Secondary|Number of Subjects Reporting Fever|Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)|15 days post each dose of varicella vaccination|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days post each dose of varicella vaccination for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
1310385|NCT02570126|Primary|Number of Subjects Reporting Fever|Fever was defined as axillary temperature above (>) 39.0 °C (> 102.2°F)|15-days (Days 0-14) post Dose 1 of varicella vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with administration of either Varilrix HSA-free or Varilrix™vaccine documented. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days (Days 0-14) post Dose 1 of varicella vaccination|||Subjects|||Number
1310386|NCT02570022|Secondary|Morphine Equivalents|Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.|four days postoperatively||||mg of morphine equivalent||Standard Deviation|Mean
1310387|NCT02570022|Primary|Pain Levels|Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.|four days postoperatively||||units on a scale||Standard Deviation|Mean
1310388|NCT02569996|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis.|||months||95% Confidence Interval|Mean
1310389|NCT02569996|Secondary|Duration of Response (DR)|Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis|||months||95% Confidence Interval|Mean
1310390|NCT02569996|Secondary|Time to Next Anti-lymphoma Treatment (TTNLT)|Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
1310391|NCT02569996|Secondary|Time to Progression (TTP)|Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
1310392|NCT02569996|Secondary|Overall Survival (OS)|Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From randomization until death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
1310393|NCT02569996|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death|Up to 27 months|Safety population: All participants who received at least one dose of study medication and had safety data after the first dose of study drug.|||participants|||Number
1310394|NCT02569996|Primary|Event-free Survival|Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.|From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
1310395|NCT02569957|Secondary|Proportion of Patients Experiencing Adverse Events, Evaluated Using the National Cancer Institute CTCAE Version 4.0|Tabulated and reported with the corresponding exact binomial confidence intervals.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310396|NCT02569957|Secondary|Duration of Response|Compared between the two arms using the two-sample Wilcoxon test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310397|NCT02569957|Secondary|Objective Tumor Response Rates|Evaluated using the exact binomial confidence intervals and compared between the two arms using the Fisher's exact test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310398|NCT02569957|Secondary|Overall Survival|Compared between the two arms using the log-rank test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310399|NCT02569957|Secondary|Progression-free Survival|Compared between the two arms using the log-rank test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310400|NCT02569957|Secondary|Change in Number of Circulating Tumor Cells|Compared pre-therapy and post- 1 cycle of therapy with a Fisher’s exact test.|Baseline to day 29|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310401|NCT02569957|Secondary|Change in Expression Levels of NFκB in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310402|NCT02569957|Secondary|Change in Expression Levels of HIF-1 Alpha in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310500|NCT02567188|Primary|Mean Hb Value at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
1324435|NCT02203630|Secondary|Number of Participants With Cardiac Arrest Events||Up to 28 days||||Participants|||Count of Participants
1310403|NCT02569957|Secondary|Change in Expression Levels of FABP4 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310404|NCT02569957|Secondary|Change in Expression Levels of TOMM20 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310405|NCT02569957|Secondary|Change in Expression Levels of MCT1 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310406|NCT02569957|Secondary|Change in Expression Levels of Cav-1 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310407|NCT02569957|Primary|Proportion of Patients Who Demonstrate a Downregulation of MCT4|The two-sided Fisher's exact test with alpha 0.05 will be used to compare the proportions of subjects who demonstrate a downregulation of MCT4 between subjects treated with topotecan hydrochloride and NAC and topotecan hydrochloride alone.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
1310408|NCT02569853|Secondary|The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary||1 hour|Subjects analyzed had efficacy data at the time of specified assessment|||Percentage of responders|||Number
1310409|NCT02569853|Primary|The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary||2 hours|Subjects analyzed had efficacy data at the time of specified assessment|||Percentage of responders|||Number
1310410|NCT02569658|Secondary|Number of Participants With Stroke|Must be diagnosed via CT scan or MRI|30 days post-operative||||Participants|||Count of Participants
1310411|NCT02569658|Secondary|Number of Participants With Pulmonary Embolism|Must be diagnosed via CT chest or V/Q lung scan|30 days post-operative||||Participants|||Count of Participants
1310412|NCT02569658|Secondary|Number of Participants With Deep Vein Thrombosis|Must be diagnosed via ultrasound duplex|30 days post-operative||||Participants|||Count of Participants
1310413|NCT02569658|Secondary|Number of Patients Transfused|Patients who received a post-op transfusion of pack red blood cells|Average of 3 days post-operatively||||Participants|||Count of Participants
1310414|NCT02569658|Secondary|Number of Units Transfused|Units of pack red blood cells that the patients recieved|Average of 3 days post-operatively||||Units of PRBCs|||Number
1310415|NCT02569658|Primary|Post-operative Blood Loss|Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.|Average of 3 days post-operatively||||mL||Standard Deviation|Mean
1310416|NCT02569437|Secondary|Visual Analog Scale|The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, > 3 to and including 7, and > 7 to and including 10, respectively.|Baseline and 12 weeks|There were 12 subject withdrawals in the treatment group and 14 in the placebo group.|||units on a scale||Standard Deviation|Mean
1310417|NCT02569437|Secondary|Subjective Symptom Composite Scoring|A subjective symptom score will be extracted from the patient’s score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: “blockage/congestion,” “runny nose,” “post-nasal discharge,” “facial pain/pressure,” and “sense of taste/smell.” Range of 0 to 25, with higher score reflecting worse symptoms.|Baseline and 12 weeks|There were 12 subject withdrawals in the treatment group and 14 in the placebo group.|||units on a scale||Standard Deviation|Mean
1310418|NCT02569437|Secondary|Middle Meatus Culture|Culture swab for the presence or absence of microbial growth|Baseline and 12 weeks||||Participants|||Count of Participants
1310419|NCT02569437|Secondary|Endoscopic Nasal Polyp Score|"0- Absence of nasal polyps~Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate~Polyps reaching below the lower border of the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils."|Baseline and 12 weeks|There were 12 subject withdrawals in the treatment group and 14 in the placebo group.|||units on a scale||Standard Deviation|Mean
1310420|NCT02569437|Primary|Sino-nasal Outcome Test (SNOT 22)|a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome|Baseline and 12 weeks|An additional 7 patients in the treatment group and 10 patients in the placebo group completed SNOT-22 scores via phone calls, even after study withdrawal.|||units on a scale||Standard Deviation|Mean
1324436|NCT02203630|Secondary|Number of Participants Developing Peripheral Limb Ischemia||Up to 28 days||||Participants|||Count of Participants
1310421|NCT02569112|Primary|General Improvement in Skin Laxity of the Flank Area|Independent reviewer to identify the six month post-treatment photograph of the flank area treated with multi-polar radiofrequency, pulsed electro-magnetic fields and vacuum suction using the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = Much worse and -3 = very much worse.|6 months||||units on a scale|flank|Standard Deviation|Mean
1310422|NCT02569086|Primary|50% f T>MIC: Free Piperacillin Concentration Maintained at a Level Four Times Above the MIC 50% of the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.||||participants|||Number
1310423|NCT02569086|Primary|100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.||||participants|||Number
1310424|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310425|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310426|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310427|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310428|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310429|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310430|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||mg/L||Standard Deviation|Mean
1310431|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.|||mg/L||Standard Deviation|Mean
1310432|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||mg/L||Standard Deviation|Mean
1310433|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310434|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 1st hour||||seconds||Standard Deviation|Mean
1310435|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
1310436|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 24th hour|All patients have gall bladder disease who are between 18-80 years old.|||mg/dL||Full Range|Median
1310437|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 1 st hour|All patients have gall bladder disease who are between 18-80 years old.|||mg/dL||Full Range|Mean
1310438|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||mg/dL||Full Range|Mean
1310439|NCT02568852|Primary|Duration of Operation|group1 and group 2(Duration of Operation)|up to 2 hours|All patients have gall bladder disease who are between 18-80 years old.|||minutes||Full Range|Mean
1310440|NCT02568384|Other Pre-specified|Average Change in Total Daily Insulin Dose From Study Start to End of Study|Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).|3 weeks||||insulin units||Full Range|Mean
1310441|NCT02568384|Other Pre-specified|Average Change in Subject Body Weight From Study Start to End of Study|Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study).|3 weeks||||pounds||Full Range|Mean
1310442|NCT02568384|Other Pre-specified|Average Change in Subject Fructosamine From Study Start to End of Study|Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study).|3 weeks|Change in umol/L|||umol/L||Full Range|Mean
1310443|NCT02568384|Other Pre-specified|HbA1c% From Study Start to End of Study|Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study).|3 weeks|Change in %HbA1c.|||%HbA1c||Full Range|Mean
1310463|NCT02567708|Secondary|Number of Participants With On-treatment Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study.|From the Start of IP up to Week 14|Safety Population|||Participants|||Number
1310444|NCT02568384|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the clarity and utility of user instructions for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or ‘6No Opinion’.|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.|||percentage of responses <or = 3|||Number
1310445|NCT02568384|Secondary|Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the basic operation of the Onyx Glucose Meter and App System. Subjects could respond '1Very Simple' or '2Simple' or '3Neither Simple nor Difficult' or '4Difficult' or '5Very Difficult' or ‘6No Opinion’.|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.|||Percentage of Responses|||Number
1310446|NCT02568384|Primary|Percent of Responses From Persons Who Performed Each “Software Operations” Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree.|"For “software operations” tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included:~Obtain a synced blood glucose reading~Initiation and use of insulin bolus calculator~Access and interpret glucose displays such as expanded graph (modal day) and sequential views."|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.|||Percent of Responses|||Number
1310447|NCT02568345|Primary|Sugammadex ED90|"Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion.~The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion."|8 minutes||||mg/kg||99% Confidence Interval|Number
1310448|NCT02568254|Primary|Overall Comfort|Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2- Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
1310449|NCT02567968|Secondary|Heart Rate|This measurement was made in order to determine whether caffeine altered heart rate in a deleterious manner.|Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.||||beats per minute||Standard Deviation|Mean
1310450|NCT02567968|Secondary|Mean Arterial Blood Pressure|This measurement was made in order to determine whether caffeine altered blood pressure in a deleterious manner.|Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.||||mmHg||Standard Deviation|Mean
1310451|NCT02567968|Secondary|Minute Ventilation|The volume of gas inhaled or exhaled from a person's lungs per minute. We wished to determine whether caffeine altered minute ventilation.|Continuous monitoring from time lma inserted until subject started to gag and it was removed, up to 2 hours post-anesthesia.||||L/minute||Standard Deviation|Mean
1310452|NCT02567968|Secondary|Bispectral Index|A bispectral index (BIS) measurement system was employed to measure depth of anesthesia. Using electrodes attached to the forehead to measure EEG, BIS outputs a dimensionless number between 0 and 100 that is proportional to the brain concentration of anesthetic and is thereby proportional to an individual’s level of consciousness (Greenwald S, Chiang HH, Devlin P, Smith C, Sigl J, Chamoun N: The Bispectral Index (Bis2.0) as a Hypnosis Measure. Anesthesiology 1994; 81: A477-a477). When the test subjects arrive, prior to anesthesia, their BIS values are in the range of 95 - 99. That corresponds to an awake and alert state. During anesthesia, most subjects are in the range of 20 - 40, corresponding to an anesthetized state. As the anesthetic wears off, the BIS values rise until they are back in the 95 - 99 range that they were prior to anesthesia. In particular, we wished to determine whether BIS exhibited more rapid recovery after caffeine infusion as compared to saline (control).|Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.|One subject was missing data at the last timepoint for the Placebo session|||units on a scale||Standard Deviation|Mean
1310453|NCT02567968|Secondary|Cognitive Test3 - Divided Attention Task|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants were asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flashed on the screen. The computer program tracked the root mean squared (RMS) deviation of the plane from the center of the road and the latency for pressing the trigger when the target appeared.|Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||mm away from optimal||Standard Deviation|Mean
1310464|NCT02567708|Secondary|Percentage of Rescue Free Days Over the Treatment Period|Daily recordings of rescue medication use were collected in an eDiary by participants. Percentage of rescue free days was calculated as the number of rescue free days divided by length of treatment period.|Up to Day 28 for each treatment period|ITT Population.|||Percentage of days||Standard Deviation|Mean
1310501|NCT02567188|Primary|Mean Hb Value at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
1310454|NCT02567968|Secondary|Cognitive Test2 - Sternberg Test of Memory|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants were asked to memorize a string of numbers. Afterwards, a computer would flash a series of random numbers on the screen and the participant was asked whether the number on the computer screen was part of the earlier string or not. In three rounds, participants were given a string of 2, then 4, then 6 numbers. The latency until the subject answered the question was monitored and this is the data summarized here.|Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||ms||Standard Deviation|Mean
1310455|NCT02567968|Secondary|Cognitive Test1 - Visual Analog Scale --- Feel Bad|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of “feel good” or “feel bad” displayed on a computer screen. Test subjects were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.|Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||units on a scale||Standard Deviation|Mean
1310456|NCT02567968|Secondary|Cognitive Test1 - Visual Analog Scale --- Feel Good|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of “feel good” or “feel bad” displayed on a computer screen. Test subjects were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.|Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||units on a scale||Standard Deviation|Mean
1310457|NCT02567968|Primary|Waking Time - Re-establishment of the Gag Reflex.|"The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject starting to gag was measured. Anesthesia suppresses the gag reflex. Immediately after anesthetizing the test subject, a laryngeal mask airway (LMA) device was inserted into the test subject airway. After anesthesia was terminated and emergence from anesthesia was taking place, the gag reflex was re-established, and the LMA produced a gag response in all test subjects. This objective and unequivocal measurement constituted the “emergence” time for each subject. The emergence time was defined as the time between terminating the anesthesia and the test subject starting to gag."|followed from the end of anesthesia to gag reflex, up to 2 hours||||minutes||Standard Deviation|Mean
1310458|NCT02567708|Secondary|Plasma Concentration of GSK2269557|Blood samples were collected from participants for pharmacokinetic (PK) analysis at Day 7, Day 14 and Day 28 pre dose. On Day 28 samples were also collected between 5-10 minutes post dose and between 2.5-3.5 hours post dose. The analysis was performed on PK Population which comprised of participants in the ITT Population for whom a PK sample was obtained and analyzed. The number of participants with data available at the specified data points are represented by n= X in the category titles.|Pre dose at Day 7 and Day 14. At Day 28 pre dose, 5-10 minutes and 2.5-3.5 hours post dose|PK Population|||Picograms per Milliliter (Pg/mL)||95% Confidence Interval|Geometric Mean
1310459|NCT02567708|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a semi-supine position at Baseline (Day 1 pre dose) , Day 7, Day 28 pre-dose in each treatment period using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). ECG values were recorded as abnormal not clinically significant (NCS) and abnormal clinically significant (CS). The number of participants with data available at the specified data points are represented by n= X in the category titles.|Up to Day 28 for each treatment period|Safety Population|||Participants|||Number
1310460|NCT02567708|Secondary|Number of Participants With Abnormal Vital Sign Values|Number of participants with abnormal values of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate were evaluated. Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 7, Day 14, Day 28 and follow-up/Early withdrawal. The number of participants with data available at the specified data points are represented by n=X in the category titles.|From start of IP up to Week 14|Safety Population|||Participants|||Number
1310461|NCT02567708|Secondary|Number of Participants With Abnormal Values of Hematology Parameters|Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria. The hematology parameters included hematocrit, hemoglobin, lymphocytes, total neutrophils, platelets and white blood cells (WBC). Participants were counted in the category that their value changes to (low, normal or high), unless there is no change in their category. The number of participants with data available at the specified data points are represented by n=X in the category titles.|From start of IP up to Week 14|Safety Population|||Participants|||Number
1310462|NCT02567708|Secondary|Number of Participants With Abnormal Values of Clinical Chemistry Parameters|Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria. The clinical chemistry parameters included albumin, calcium, creatinine, glucose, potassium and sodium. Participants were counted in the category that their value changes to (low, normal or high), unless there is no change in their category. The number of participants with data available at the specified data points are represented by n=X in the category titles.|From start of IP up to Week 14|Safety Population|||Participants|||Number
1316288|NCT02397694|Secondary|The Change From Baseline in log10 HIV-1 RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1310465|NCT02567708|Secondary|Mean Number of Inhalations Per Day of Rescue Medication (Salbutamol) Over the Treatment Period|Daily recordings of rescue medication use were collected in an eDiary by participants. The mean number of inhalations per day of rescue medication was calculated for each participant as number of inhalations over the time period of interest divided by number of days when rescue medication was taken over the time period of interest.|Up to Day 28 for each treatment period|ITT Population. Only those participants with data available at specified time point were analyzed.|||Inhalations/day||Standard Deviation|Mean
1310466|NCT02567708|Secondary|Change From Baseline in Trough Fractional Exhaled Nitric Oxide (FeNO) at Day 7, Day 14 and Day 28|Participants with asthma have high levels of NO in their exhaled breath. Evaluation of FeNO is a quantitative, noninvasive method of measuring airway inflammation to assess airway diseases including asthma. FeNO was measured in the clinic using a handheld electronic device. Change from Baseline for Day 7, Day 14 and Day 28 was calculated as the post-Baseline value minus the Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7, Day 14 and Day 28 for each treatment period|ITT Population.|||Part per billion (PPB)||95% Confidence Interval|Median
1310467|NCT02567708|Secondary|Change From Baseline in Daily Peak Expiratory Flow (PEF) Averaged Over the Treatment Period|Triplicate measurements of PEF were collected in an eDiary pre-dose before breakfast (AM), and approximately 12 hours later at evening (PM). The average change from Baseline was calculated by summing the total value of the endpoint (i.e. change from Baseline) within the time period of interest and dividing by the number of days with non-missing data for that endpoint to obtain an average for each subject. The AM Baseline is the Day 1 AM value, the PM Baseline is the last PM reading prior to taking the first dose of blinded study medication within that Treatment Period. The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline and up to Day 28 for each treatment period|ITT Population|||Liter/minute||Standard Deviation|Mean
1310468|NCT02567708|Secondary|Change From Baseline in Daily FEV1 Averaged Over the Treatment Period|Triplicate measurements of FEV1 were collected in an eDiary pre-dose before breakfast [ante meridiem (AM)], and approximately 12 hours later at evening [post-meridiem (PM)]. The average change from Baseline was calculated by summing the total value of the endpoint (i.e. change from Baseline) within the time period of interest and dividing by the number of days with non-missing data for that endpoint to obtain an average for each subject. The AM Baseline is the Day 1 AM value, the PM Baseline is the last PM reading prior to taking the first dose of blinded study medication within that Treatment Period. The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline and up to Day 28 for each treatment period|ITT Population.|||Liter||Standard Deviation|Mean
1310469|NCT02567708|Secondary|Change From Baseline in Asthma Control Test (ACT) Score at Day 28|The total ACT score is the sum of five-item questionnaires developed as a measurement of asthma control. Total score can range from five (worse control) to 25 (full control), with higher scores reflecting greater asthma control. Total ACT score at Day 1 (Baseline) and Day 28 in both Treatment Periods was used for this analysis. Change from Baseline in ACT was calculated as post-Baseline value minus Baseline value where Baseline was defined as Day 1 (pre-dose).|Baseline and Day 28 for each treatment period|ITT Population. Only those participants with data available at specified time point were analyzed.|||Score on a scale||95% Confidence Interval|Median
1310470|NCT02567708|Secondary|Change From Baseline in FEV1/FVC at Day 7, Day 14 and Day 28|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the total amount of air exhaled during the FEV test. Change from Baseline in FEV1/FVC at Day 7, Day 14 and Day 28 was calculated as post-Baseline value minus Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7, Day 14 and Day 28 for each treatment period|ITT Population.|||Percentage of exhaled air||95% Confidence Interval|Median
1310471|NCT02567708|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Day 7, Day 14 and Day 28|FVC is defined as the total amount of air exhaled during the FEV test. Data was collected pre-dose at Baseline (Day 1), Day 7, Day 14 and Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7, Day 14 and Day 28 for each treatment period|ITT Population.|||Liter||95% Confidence Interval|Median
1310472|NCT02567708|Secondary|Change From Baseline in Trough FEV1 at Day 7 and Day 14|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hrs after the last administration of study drug. Change from Baseline values were calculated as post-Baseline values minus Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7 and Day 14 for each treatment period|ITT Population.|||Liters||95% Confidence Interval|Median
1310473|NCT02567708|Secondary|Weighted Mean (0-4 Hours) FEV1 at Day 28|The weighted mean FEV1 on Day 28 was calculated using data collected pre-dose and at 1 hour, 2 hours, 3 hours, and 4 hours post-dose. The weighted mean FEV1 was derived by calculating the average area under the curve using the trapezoidal rule, and then dividing by the relevant time interval.|Day 28 for each treatment period|ITT Population. Only those participants with data available at specific time point were analyzed.|||Liters||95% Confidence Interval|Median
1310474|NCT02567708|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 in Per Protocol (PP) Population|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. FEV1 was measured using a spirometer. Change from Baseline is calculated as post-Baseline value minus Baseline value where Baseline is defined as Day 1 (pre-dose). The analysis was performed on the PP Population which comprised of all participants in the ITT Population not identified as major protocol violators.|Baseline and Day 28 for each treatment period|PP Population|||Liters||95% Confidence Interval|Median
1310475|NCT02567708|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 in Intent-To-Treat (ITT) Population|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. FEV1 was measured using a spirometer. Change from Baseline is calculated as post-Baseline value minus Baseline value where Baseline is defined as Day 1 (pre-dose).|Baseline and Day 28 for each treatment period|The analysis was performed on the ITT Population which comprised of all participants who received at least one dose of trial medication and have at least one post-dose efficacy assessment. Six participants had entered the study without spirometric evidence of disease, and were excluded from the ITT population prior to unblinding.|||Liters||95% Confidence Interval|Median
1310476|NCT02567552|Primary|Endometrial Gene Expression Difference (Fold Change >3)|Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3)|5 days|We assessed the expressed genes with a significantly high gene expression difference between treatments (adj-p-value < 0.05, Fold Change>3) This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected|||Endometrial genes|Endometrial genes||Number
1310477|NCT02567552|Secondary|Number of Participants With Side Effects During the Study|"Number of Participants with side effects during the study"|5 days||||participants|||Number
1310478|NCT02567552|Secondary|Blood LH Level|Blood Luteinizing hormone level 5 days after progesterone treatment|5 days||||pg/mL||Standard Deviation|Mean
1310479|NCT02567552|Secondary|Blood Progesterone Level|Blood progesterone level 5 days after progesterone treatment|5 days||||ng/mL||Standard Deviation|Mean
1310480|NCT02567552|Secondary|Blood Estradiol Level|Blood estradiol level 5 days after progesterone treatment|5 days||||pg/mL||Standard Deviation|Mean
1310481|NCT02567552|Secondary|Blood LH Level|Blood Luteinizing hormone level on the day of follicular puncture|day 0||||pg/mL||Standard Deviation|Mean
1310482|NCT02567552|Secondary|Blood Progesterone Level|Blood progesterone level on the day of follicular puncture|day 0||||ng/mL||Standard Deviation|Mean
1310483|NCT02567552|Secondary|Blood Estradiol Level|Blood estradiol level on the day of follicular puncture|day 0||||pg/mL||Standard Deviation|Mean
1310484|NCT02567552|Secondary|Endometrial Thickness|Endometrial thickness measurement by means of transvaginal ultrasound.|5 days||||mm||Standard Deviation|Mean
1310485|NCT02567552|Primary|Endometrial Gene Expression|Gene expression profile of endometrial|5 days|"We assessed the gene expression of 238 endometrial genes to detect differences in gene expression between treatments.~This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected"|||Endometrial genes|Endometrial genes||Number
1310486|NCT02567552|Primary|Endometrial Maturation Using Noyes' Criteria|Endometrial dating of luteal phase days according to the Noyes criteria|5 days||||days||Standard Deviation|Mean
1310487|NCT02567552|Primary|Decidualization of Stromal Cell|Rate of transformation of endometrial stromal fibroblasts into specialized secretory decidual cells (three categories: less than 25%, between 26% and 50%, and over 50%)|5 days||||participants|||Number
1310488|NCT02567552|Primary|Predecidual Transformation|Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase|5 days||||participants|||Number
1310489|NCT02567188|Secondary|Percentage of Participants Who Required Renal Replacement Therapy|Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
1310490|NCT02567188|Secondary|Percentage of Participants Who Required Blood Transfusion||Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
1310491|NCT02567188|Secondary|Number of Participants With Different Medication Treatment|Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.|Pre-baseline (Month -6) to Month 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure.|||participants|||Number
1310492|NCT02567188|Secondary|Percentage of Participants With Changes in AntihypertensiveTreatment|Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
1310493|NCT02567188|Secondary|Percentage of Participants With Changes in Immunosuppressive Treatment|Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
1310494|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Baseline to Month 12|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between baseline and Month 12.|||percentage of participants|||Number
1310495|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Pre-baseline (Month -6) to Baseline|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between pre-baseline (Month -6) and baseline.|||percentage of participants|||Number
1310496|NCT02567188|Primary|Mean Hb Value at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
1310502|NCT02567188|Secondary|Percentage of Participants With Changes in Iron Supplement|Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
1310503|NCT02567188|Secondary|Correlation of Hb Levels With Levels of Inflammation||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.||||||
1310504|NCT02567188|Secondary|Correlation of Hb Levels With Underlying Disease||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.||||||
1310505|NCT02567188|Secondary|Percentage of Participants With Number of MIRCERA Dose Changes||Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with available data for this outcome measure.|||percentage of participants|||Number
1310506|NCT02567188|Secondary|Percentage of Participants With Change in MIRCERA Treatment|Change in MIRCERA treatment included changes in dose, frequency, and route of administration.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure. n = number of participants evaluable at the specified time frame.|||percentage of participants|||Number
1310507|NCT02567188|Primary|Mean Hb Value at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
1310508|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
1310509|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
1310510|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
1310511|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
1310512|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
1310513|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
1310514|NCT02567188|Primary|Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
1310515|NCT02566759|Secondary|Part 2 and 3: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-831||Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.|||ng*hr/mL||Standard Deviation|Mean
1310516|NCT02566759|Secondary|Part 1, 2 and 4: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831.|||ng*hr/mL||Standard Deviation|Mean
1310517|NCT02566759|Secondary|Part 1, 2 and 4: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1310518|NCT02566759|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose; Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.|||hours||Full Range|Median
1310519|NCT02566759|Secondary|Part 2 and 3: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-831||Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.|||ng/mL||Standard Deviation|Mean
1310520|NCT02566759|Secondary|Part 1, 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1346745|NCT01844765|Secondary|PK Profile of Nilotinib in Pediatric Patients|Population PK parameters of nilotinib|up to 12 cycles||2021-10-31|10/2021||||
1310521|NCT02566759|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose|Markedly abnormal criteria for ECG was assessed. The lower cut-off point criteria and upper cut-off point criteria are as follow: heart rate <50 beats per minute (bpm) to >120 bpm; PR interval less than or equal to (<=) 80 millisecond (msec) to greater than or equal to (>=) 200 msec; QRS interval <=80 msec to >=180 msec; QT interval <=300 msec to >=460 msec; QTcB interval <=300 msec to >=500 msec or >=30 msec change from baseline and >=450 msec; QT interval with Fridericia’s correction method (QTcF) interval <=50 msec to >=500 msec or >=30 msec change from baseline and >=450 msec.|Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1310522|NCT02566759|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|Markedly abnormal criteria for vital signs measurement was assessed. The lower criteria and upper criteria for abnormality are as follow: systolic blood pressure at less than (<) 85 millimeter of mercury (mm Hg) to greater than (>) 180 mm Hg; diastolic blood pressure < 50 mm Hg to >110 mm Hg; pulse rate <50 bpm to >120 bpm; Temperature <35.6 degree Celsius to >37.7 degree Celsius.|Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1310523|NCT02566759|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|Clinical laboratory tests included hematology, serum chemistry and urinalysis.|Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1310524|NCT02566759|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1310525|NCT02566135|Primary|Total Intubation Time||5 minutes||||Second||Standard Deviation|Mean
1310526|NCT02566135|Primary|Time of Insertion||5 minutes||||Seconds||Standard Deviation|Mean
1310527|NCT02566135|Secondary|Diastolic Blood Pressure|"Diastolic blood pressure measured at following time intervals.~Base line~After Dexmedetomidine injection~After Induction~Supraglottic airway insertion~Ventilating bougie insertion~ETT insertion~3 minute after ETT insertion~5 minute after ETT insertion~7 minute after ETT insertion~10 minutes after ETT insertion~15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends."|25 minutes||||mmhg||Standard Deviation|Mean
1310528|NCT02566135|Secondary|Systolic Blood Pressure|"Systolic blood pressure measured at following time intervals.~Base line~After Dexmedetomidine injection~After induction of anaesthesia~Supraglottic airway insertion~Ventilating bougie insertion~ETT insertion~3 minute after ETT insertion~5 minute after ETT insertion~7 minute after ETT insertion~10 minute after ETT insertion~15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends."|25 minutes||||mmhg||Standard Deviation|Mean
1310529|NCT02566135|Secondary|Heart Rate|"Heart rate to observe at the following time intervals.~Base line~After induction~After dexmedetomidine injection~Supraglottic airway insertion~Ventilating bougie insertion~ETT insertion~3minute after ETT insertion~5 minute after ETT insertion~7 minute after ETT insertion~10 minute after ETT insertion~15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here."|25 minutes||||beats per minute||Standard Deviation|Mean
1310530|NCT02566135|Primary|Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie||30 seconds||||attempt|||Number
1310531|NCT02566135|Primary|Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA||45 seconds||||attempt|||Number
1310532|NCT02566135|Primary|Number of Attempts for I-gel or Classic-LMA Insertions||60 seconds||||attempt|||Number
1310533|NCT02566005|Secondary|Estimated Blood Loss||Day 1||||ml||Standard Deviation|Mean
1310534|NCT02566005|Secondary|Incidence of Patient Discomfort||Day 1|data not collected||||||
1310535|NCT02566005|Secondary|Incidence of Uterine Tachysystole||Day 1||||Participants|||Count of Participants
1310536|NCT02566005|Secondary|Incidence of Chorioamnionitis||Day 1||||Participants|||Count of Participants
1310537|NCT02566005|Secondary|The Time From Active Phase to Delivery||Day 1||||hours||Standard Deviation|Mean
1310538|NCT02566005|Secondary|The Time From Induction Until to Active Phase Labor||Day 1||||hours||Standard Deviation|Mean
1310539|NCT02566005|Primary|Per Treatment Protocol: Time (Hours) From Induction to Delivery||day 1|those participants on treatment protocol|||hours||Standard Deviation|Mean
1310540|NCT02566005|Primary|Time From Induction to Delivery: CD|Time (hours) from induction to delivery: Cesarean Delivery (CD)|Day 1||||hours||Standard Deviation|Mean
1310541|NCT02566005|Primary|Time From Induction to Delivery: VD|Time (hours) from induction to delivery: Vaginal Delivery (VD)|Day 1||||hours||Standard Deviation|Mean
1310542|NCT02566005|Primary|Time (Hours) From Induction to Delivery: Multiparous||Day 1|for nulliparous participants|||hours||Standard Deviation|Mean
1310543|NCT02566005|Primary|Time (Hours) From Induction to Delivery: Nulliparous||Day 1|for nulliparous participants|||hours||Standard Deviation|Mean
1310544|NCT02566005|Primary|The Time Interval From Induction to Delivery: All Participants|During labor from the start of the induction to the delivery|Day 1||||hours||Standard Deviation|Mean
1310545|NCT02565628|Secondary|Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7|AUC24 of PF-06669571 refers to the area under the curve from time zero to 24 hours post dose on Day 7. AUC24 was determined by using linear/log trapezoidal method|0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7|The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1310556|NCT02565628|Primary|Number of Participants With New Onset and Worsening of Post-Baseline Suicidality.|Number of participants with new onset and worsening of post-baseline suicidality was reported|Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)|All enrolled participants who started treatment|||participants|||Number
1310546|NCT02565628|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7|Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 PK concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.|||hr||Full Range|Mean
1310547|NCT02565628|Secondary|Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7|AUC12 of PF-06669571 refers to the area under the curve from time zero to 12 hours post dose on Day 1 and Day 7. AUC12 was determined by using linear/log trapezoidal method.|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1310548|NCT02565628|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7|Cmax of PF-06669671 was observed directly from data on Day 1 and Day 7|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 pharmacokinetics(PK) concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310549|NCT02565628|Primary|Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality)|Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),liver function(total bilirubin, direct bilirubin, aspartate, aspartate aminotransferase, alanine, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose) ,and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, qualitative ketones, qualitative bilirubin, nitrites, leukocyte esterase, urine urobilinogen, urine leukocyte, esterase and microscopy).|Screening, Days 1, 4, and 7, and follow-up visit|All enrolled participants who started treatment.|||participants|||Number
1310550|NCT02565628|Primary|Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)|Number of participants with ECG(standard 12-lead) meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>=25/50%; Criterion B: maximum QRs complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.|Screening, Days 1, 7, and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
1310551|NCT02565628|Primary|Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)|The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRs complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia’s formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia’s correction) >=500 msec|Screening, Days 1, 7, and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
1310552|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)|The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP (SBP) >=30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >=30 mmHg; Criterion C: maximum decrease from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum decrease from baseline in standing diastolic BP(DBP) >=20 mmHg|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
1310553|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)|The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP (SBP) >=30 millimeters of mercury (mmHg); Criterion B maximum increase from baseline in standing SBP >=30 mmHg; Criterion C: maximum increase from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum increase from baseline in standing diastolic BP(DBP) >=20 mmHg|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
1310554|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)|Number of participants with supine and standing vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for supine/standing systolic blood pressure (SBP), supine/standing diastolic blood pressure (DBP), and supine/standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: (1) absolute supine SBP <90 millimeters of mercury (mmHg); (2) absolute standing SBP <90 mmHg; (3)absolute supine DBP<50mmHg; (4)absolute standing DBP<50mmHg (5) absolute supine pulse rate <40 beats per minute (bpm); (6) absolute supine pulse rate >120 bpm;(7) absolute standing pulse rate <40 bpm; (8) absolute standing pulse rate >140 bpm.|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
1310555|NCT02565628|Primary|Number of Participants With Treatment Emergent Adverse Events (All Causalities)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.|Day 1 to 28 calendar days after the last dose of investigational product|All enrolled participants who started treatment|||participants|||Number
1316373|NCT02393547|Secondary|Waist Circumference|Change in waist circumference from baseline to week 12|12 Weeks|subjects (n=10) who met criteria for prolonged smoking abstinence at week 12|||cm||Standard Deviation|Mean
1310557|NCT02565628|Primary|Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit|"The number of participants in each C-CASA category was mapped from Columbia-Suicide Severity Rating Scale (C-SSRS) data. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3) (Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act or some intent to act, with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on Has subject engaged in non-suicidal self-injurious behavior)."|Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)|All enrolled participants who started treatment.|||participants|||Number
1310558|NCT02565628|Primary|Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III at Day 7.|The total MDS-UPDRS score is the most common method of evaluating the severity of Parkinson’s disease across behaviors, activities of daily living, motor abilities, and other complications of Parkinson’s disease. The MDS-UPDRS focuses primarily on measuring impairments associated with Parkinson’s disease, with subsections organized according to motor and non-motor aspects of the disease. Part III assesses the motor signs of Parkinson’s disease. Higher total scores indicate more severe motor signs of Parkinson’s disease. Negative changes from baseline indicate improvement. MDS-UPDRS Part III total motor score is comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate and 4 = severe.|Day 7|All enrolled participants who started treatment.|||Percentage||Standard Error|Least Squares Mean
1310559|NCT02565485|Secondary|Adverse Events (Pulmonary Edema)|Pulmonary edema occurring after preload bolus through delivery was considered an adverse event.|Duration of intrapartum course||||Participants|||Count of Participants
1310560|NCT02565485|Secondary|Interventions to Correct Maternal Hypotension or Fetal Heart Rate Abnormalities (Position Change, Supplemental Oxygen, Vasopressor Support, Emergent Operative Delivery)||First 60 minutes following epidural placement||||Participants|||Count of Participants
1310561|NCT02565485|Secondary|New Onset Hypotension (>20% Decrease in Systolic and/or Diastolic Blood Pressure)||First 60 minutes following epidural placement||||Participants|||Count of Participants
1310562|NCT02565485|Primary|Incidence of New-onset Category II or III Fetal Heart Rate Tracings|Each fetal heart rate tracing was evaluated in 15 min increments from the completion of epidural placement and initial dose administration. ACOG Category I, II, and III was assigned to each 15 min increment.|First 60 minutes following epidural placement||||Participants|||Count of Participants
1310563|NCT02565381|Other Pre-specified|Use of Text Messaging Program|Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT.|8 weeks||||Participants|||Count of Participants
1310564|NCT02565381|Other Pre-specified|Mobile Phone Retention|Percentage of participants who still have their mobile phone at the end of the study.|8 weeks||||Participants|||Count of Participants
1310565|NCT02565381|Other Pre-specified|Recruitment Time|Total time to recruit, enroll, and randomize 75 study participants.|Until target number of participants is reached; anticipate ~6 months||||months|||Number
1310566|NCT02565381|Secondary|Nicotine Patch Use|Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.|8 weeks|Participants with missing data at a given time point were excluded from calculation of mean past-week patch use at that time point.|||Days||Standard Deviation|Mean
1310567|NCT02565381|Secondary|Counseling Visit Attendance|Percentage of 8 counseling visits attended.|8 weeks||||percentage of visits||Standard Deviation|Mean
1310568|NCT02565381|Secondary|Study Visit Attendance|Percentage of 14 assessment visits attended.|8 weeks||||percentage of visits||Standard Deviation|Mean
1310569|NCT02565381|Secondary|Change in Behavioral Health|Past-month drug use severity (score range 0-1), past-month alcohol use severity (score range 0-1), and past-month psychiatric severity (0-1) were each assessed with the Addiction Severity Index (ASI) – 5th Edition, at baseline and at the 10th and 14th study visits. For each ASI measure, higher scores represent greater drug, alcohol, or psychiatric severity. Changes in ASI scores between baseline and 4 or 8 weeks can range from -1 to +1. When interpreting changes in scores, negative values indicate decreases in scores from baseline to 4 or 8 weeks, and positive values indicate increases in scores from baseline to 4 or 8 weeks.|4 weeks and 8 weeks|Participants with missing data at a particular time point are excluded from calculation of mean change in ASI scores at that time point.|||units on a scale||Standard Deviation|Mean
1310570|NCT02565381|Secondary|Change in Cigarette Consumption|Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at the 8 assessment visits occurring on Fridays.|Once per week for 8 weeks|Participants with missing data at a given time point are excluded from calculation of mean changes in cigarette consumption for that time point.|||Cigarettes per day||Standard Deviation|Mean
1310571|NCT02565381|Secondary|Smoking Abstinence at End of Study|Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level <8ppm, at the 14th (final) study visit.|8 weeks||||Participants|||Count of Participants
1310572|NCT02565381|Secondary|Percentage of Visits Abstinent of Smoking|Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level <8ppm.|8 weeks|Participants with missing data at a given time point were assumed non-abstinent at that time point.|||percentage of visits||Standard Deviation|Mean
1310573|NCT02565381|Primary|Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks|The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide <8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)|Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period|Participants with missing data at a given time point were assumed non-abstinent at that time point.|||Participants|||Count of Participants
1350636|NCT01788215|Secondary|Free Testosterone in Serum||week 24|in the sugar till arm, one participant dropped out at week 12|||pg/mL||Standard Deviation|Mean
1310574|NCT02565108|Primary|PK: Geometric Mean Ratios Of CLB And N-CLB For AUCtau On Day 33 Compared With Day 1|The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for AUCtau to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% CI approach for the between time point ratios of geometric means of AUCtau was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects.|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||Ratio||90% Confidence Interval|Number
1310575|NCT02565108|Secondary|Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as an adverse event with an onset date on or after the first dose of IMP. If an adverse event (AE) had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced 1 or more severe TEAEs after screening up to Day 71.~A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module."|Postdose on Day 2 up to Safety follow-up (Day 71)|Safety Set: all participants who received at least 1 dose of IMP (GWP42003-P or placebo). Participants were analyzed according to the treatment they received.|||Participants|||Count of Participants
1310576|NCT02565108|Primary|PK: Geometric Mean Ratios Of CLB And N-CLB For Cmax On Day 33 Compared With Day 1|The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for Cmax to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% confidence interval (CI) approach for the between time point ratios of geometric means of Cmax was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects.|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||Ratio||90% Confidence Interval|Number
1310577|NCT02565108|Primary|PK: Area Under The Plasma Concentration‑Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33|"The AUCtau of CLB and its primary metabolite N-CLB was measured on Day 1 (before first GWP42003-P dose; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose."|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310578|NCT02565108|Primary|PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33|"The tmax of CLB and its primary metabolite N-CLB was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose."|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||h||Full Range|Median
1310579|NCT02565108|Primary|Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33|"The Cmax of CLB and its primary metabolite N-desmethylclobazam (N-CLB) was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose."|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310580|NCT02564718|Primary|Anti-factor Xa Activity (Anti-Xa) Values at Day 8|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|10-16 hours post-dose on Day 8 (both bid and tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||microgram per liter (mcg/L)||Standard Deviation|Mean
1350637|NCT01788215|Secondary|Free Testosterone in Serum||week 12||||pg/mL||Standard Deviation|Mean
1310581|NCT02564718|Primary|Anti-factor Xa Activity (Anti-Xa) Values at Day 3|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||microgram per liter (mcg/L)||Standard Deviation|Mean
1310582|NCT02564718|Primary|Anti-factor Xa Activity (Anti-Xa) Values at Day 1|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||microgram per liter (mcg/L)||Standard Deviation|Mean
1310583|NCT02564718|Primary|Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.|10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
1310584|NCT02564718|Primary|Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.|10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
1310585|NCT02564718|Primary|Change From Baseline in Prothrombin Time at Day 3|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.|10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
1310586|NCT02564718|Primary|Change From Baseline in Prothrombin Time at Day 1|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.|10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)|Pharmacodynamic (PD) analysis set (PDS) included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
1310587|NCT02564718|Primary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8|Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.|10 to 16 hours post-dose on Day 8 (bid dosing)|PKS included all participants with at least one PK sample in accordance with the PK sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
1310588|NCT02564718|Primary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3|Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.|2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing)|PKS included all participants with at least one PK sample in accordance with the PK sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
1310589|NCT02564718|Secondary|Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging|Symptomatic recurrence of thromboembolism and asymptomatic deterioration was documented using the appropriate imaging test and confirmed by CIAC which was unaware of treatment assignment. Asymptomatic deterioration in thrombotic burden on repeat imaging, as assessed by the CIAC. Adjudication results were the basis for the final analyses.|From start of study drug administration until 30-day post study treatment period|Full analysis set (FAS) included all participants from whom informed consent was obtained and who contributed any data thereafter.|||count of participants|||Number
1310590|NCT02564718|Secondary|Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events|Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and •associated with a fall in hemoglobin of 2 gram/deciliter (g/dL) or more, •leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or •occurring in a critical site, example: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or •contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: •medical intervention, or •unscheduled contact (visit or telephone call) with a physician, or •cessation (temporary) of study treatment, or •discomfort for the child such as pain|From start of study drug administration until 30-day post study treatment period|Safety analysis set (SAF) included all participants who received at least one dose of rivaroxaban.|||count of participants|||Number
1310591|NCT02564718|Primary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1|Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.|30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing)|Pharmacokinetic (PK) analysis set (PKS) included all participants with at least one PK sample in accordance with the PK sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
1310592|NCT02564211|Secondary|Change From Baseline in HbA1c|Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage.|Baseline and Week 52|All participants who received at least 1 dose of treatment period study medication. had at least 1 measurement of the outcome variable (baseline or post-baseline) and had baseline data for those analyses that required baseline data.|||Percent||95% Confidence Interval|Mean
1310593|NCT02564211|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to an AE|The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.|Up to 52 weeks|All participants who received at least 1 dose of treatment period study medication.|||Percentage of Participants|||Number
1310594|NCT02564211|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)|An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded.|Up to 54 weeks|All participants who received at least 1 dose of treatment period study medication.|||Percentage of participants|||Number
1310595|NCT02564055|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|"Single measurements of 12-lead ECGs were obtained at Baseline , Week 1, Week 12, Week 14 (follow up 1), EW and at any time post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). Baseline was defined as the latest assessment prior to the first dose. For multiple ECGs at one visit, or Any visit post-screen, a participant was categorized as Abnormal if >=1 assessment was abnormal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles)."|Baseline, Week 1, 12, 14, EW ( up to Week 14), post-screen|Safety population|||Participants|||Number
1310596|NCT02564055|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance|Blood samples were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included SBP, DBP and pulse rate. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Participants|||Number
1310597|NCT02564055|Secondary|Change From Baseline in Temperature|Temperature were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Degree Celsius||Standard Deviation|Mean
1310598|NCT02564055|Secondary|Change From Baseline in Pulse Rate|Pulse rate were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
1310599|NCT02564055|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1310600|NCT02564055|Secondary|Number of Participants With Immunoglobulin Data Outside the Reference Range|Blood samples were collected from participants for evaluation of immunoglobulin data outside the reference range at Baseline, Week 4, Week 8, Week 12 and any visit post-screen. The immunoglobulin parameters included IgA, IgG and Ig M. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week, 4, 8, 12, post-screen (up to Week 16)|Safety population|||Participants|||Number
1310601|NCT02564055|Secondary|Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels|Blood samples were collected to evaluate change from Baseline in IgA, IgG, IM values at Baseline throughout the 12 weeks of study treatment. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week, 4, 8 and 12|Safety population|||G/L||Standard Deviation|Mean
1310602|NCT02564055|Secondary|Number of Participants With Immunopheotyping Data Outside the Reference Range|Blood samples were collected from participants for evaluation of immunophenotyping parameters by Potential Clinical Importance Criteria at Baseline, Week 4, Week 8, Week 12 nd any visit post-screen. The immunophenotyping parameters included CD 19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cyto. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week, 4, 8, 12 and post-screen (up to Week 16)|Safety population|||Participants|||Number
1310603|NCT02564055|Secondary|Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels|Blood samples were collected to evaluate change from Baseline in total T lympho, B lympho, T and B NK cells and (Foxp3) values at Baseline throughout the 12 weeks of study treatment. The immunophenotyping parameters included cluster of differentiation (CD)19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cytometry (cyto). Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week, 4, 8 and 12|Safety population|||GI/L||Standard Deviation|Mean
1310604|NCT02564055|Secondary|Number of Participants With Hematology Data of Potential Clinical Importance|Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included hematocrit, hemoglobin, lymphocytes, neutrophils, platelet and leukocytes. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week 2, 4, 8, 12, 14, early withdrawal, and post screen (up to Week 16)|Safety Population|||Participants|||Number
1351304|NCT01780922|Primary|Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2’-Deoxyguanosine (8-OHdG)||0, 2, 4, 8, 24 h||||ng/mL||Standard Error|Mean
1310605|NCT02564055|Secondary|Change From Baseline in Erythrocyte Count|Blood samples were collected to evaluate change from Baseline in erythrocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Weeks 2, 4, 8, 12, 14, EW (week up to 14)|Safety Population|||Tetra cells per liter (TI/L)||Standard Deviation|Mean
1310606|NCT02564055|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV)|Blood samples were collected to evaluate change from Baseline in MCV and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Femtoliter (fL)||Standard Deviation|Mean
1310607|NCT02564055|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH)|Blood samples were collected to evaluate change from Baseline in MCH and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Picogram (Pg)||Standard Deviation|Mean
1310608|NCT02564055|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||G/L||Standard Deviation|Mean
1310609|NCT02564055|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected to evaluate change from Baseline in hematocrit and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
1310610|NCT02564055|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count|Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Giga cells per liter (GI/L)||Standard Deviation|Mean
1310611|NCT02564055|Secondary|Number of Participants With Chemistry Data of Potential Clinical Importance|Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included alk.phosph., ALT, AST, bilirubin, calcium, CO2, creatinine, glucose and potassium. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Participants|||Number
1310612|NCT02564055|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)|Blood samples were collected to evaluate change from Baseline in calcium, chloride, CO2, glucose, potassium, sodium and BUN values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1310613|NCT02564055|Secondary|Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate|Blood samples were collected to evaluate change from Baseline in direct and total bilirubin, creatinine and urate values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1310614|NCT02564055|Secondary|Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT)|Blood samples were collected to evaluate change from Baseline in Alk.phosph., ALT, AST and GGT values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||International unit per liter (IU/L)||Standard Deviation|Mean
1310615|NCT02564055|Secondary|Change From Baseline in Albumin and Total Protein|Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Gram per Liter (G/L)||Standard Deviation|Mean
1310616|NCT02564055|Secondary|Number of Participants With Reported Tolerability Score of 0 to 4 Over Time|Participants were asked to use a 5-point tolerability scale from 0 (none) to 4 (severe) to assess the presence and degree of burning/stinging and itching at the application sites that has generally been experienced following application of the study treatment. The score represented an ‘average’ across all application sites. A score of 3 or 4 was reported as an AE. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, EW (up to Week 14)|Safety Population|||Participants|||Number
1310617|NCT02564055|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Treatment emergent AEs (TEAE) is defined as AE occurred on or after study treatment start date and on or before last visit. Number of participants with AEs and serious TEAEs were presented. The analysis was performed on Safety population which comprised of all participants who receive at least one dose of study treatment.|Weeks 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Participants|||Number
1310618|NCT02564055|Secondary|Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit|The IGA is a clinical tool for assessing the current state/severity of a participant’s AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants who have an IGA score of clear or almost clear and a minimum 2 grade improvement from Baseline to each study visit in IGA score was presented. The statistical analysis was performed using a repeated measures factorial logistic regression model with covariates for dose, frequency of administration, and study day as well as a dose by frequency interaction term. The analysis was performed on ITT Population which comprised of all randomized participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to week 16)|ITT Population|||Percentage of participants|||Number
1310619|NCT02564055|Secondary|Mean Change From Baseline in IGA Score|The IGA is a clinical tool for assessing the current state/severity of a participant’s AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. Score ranges from 0 (clear) to 4 (severe). Higher values represent a severe disease. Mean change from Baseline in IGA score was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
1310620|NCT02564055|Secondary|Mean Change From Baseline in Body Surface Area (Percent BSA)|The extent of BSA affected by AD is a general indicator of disease severity and the assessment of BSA with AD was performed separately for four body surface regions: the head (h), the upper extremities (u), the trunk (t) and the lower extremities (l), corresponding to 10, 20, 30, and 40 percent of the total body area, respectively. Mean change from Baseline in percent BSA was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of surface area||Standard Deviation|Mean
1310621|NCT02564055|Secondary|Mean Percent Change From Baseline in Individual Signs of TSS|The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. NA indicates that data were not available. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage Change||Standard Deviation|Mean
1310622|NCT02564055|Secondary|Mean Change From Baseline in Individual Signs of TSS|The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
1310639|NCT02564042|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1310623|NCT02564055|Secondary|Mean Percent Change From Baseline in TSS|A target lesion of at least 3 cm^2 was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) , with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage Change||Standard Deviation|Mean
1310624|NCT02564055|Secondary|Mean Change From Baseline in Total Severity Score (TSS)|A target lesion of at least 3 centimeter square (cm^2) was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe), with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
1310625|NCT02564055|Secondary|Percentage of Participants With >=75 Percent Improvement From Baseline in EASI|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=75 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
1310626|NCT02564055|Secondary|Percentage of Participants With >=50 Percent Improvement From Baseline in EASI|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=50 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
1310627|NCT02564055|Secondary|Percentage of Participants With an IGA Score of 0 or 1 at Each Visit|The IGA is a clinical tool for assessing the current state/severity of a participant’s AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with an IGA score of 0 or 1 at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
1310628|NCT02564055|Secondary|Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit|The IGA is a clinical tool for assessing the current state/severity of a participant’s AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with a minimum 2-grade improvement in IGA score from Baseline at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and early withdrawal (EW) visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
1310629|NCT02564055|Secondary|Mean Percent Change From Baseline in EASI Score|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean percent change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage Change||Standard Deviation|Mean
1310756|NCT02561572|Secondary|Amsterdam Preoperative Anxiety and Information Scale Scores|The Amsterdam Pre-operative Anxiety and Information Scale has four questions relating to anxiety (APAISa, Table 2) and has been shown to correlate well with the full version of the State-Trait Anxiety Inventory. The scores from the anxiety elements of the questionnaire are added together giving a possible of total score of 4 (low anxiety) to 20 (high anxiety).|30 minutes after intervention||||units on a scale||Inter-Quartile Range|Median
1310630|NCT02564055|Secondary|Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
1310631|NCT02564055|Secondary|Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit|NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Percentage of participants who achieved a minimum 3-point improvement in itch/pruritus (NRS) from Baseline to each study visit were measured. Baseline was defined as the latest assessment prior to first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, early withdrawal (EW) (up to Week 16)|ITT Population|||Percentage of Participants|||Number
1310632|NCT02564055|Secondary|Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score|NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean percent change in weekly average of daily itch/pruritus based on the NRS was presented using mean and SD from Baseline to Week 12. Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.|Baseline and up to Week 12|ITT Population|||Percentage Change||Standard Deviation|Mean
1310633|NCT02564055|Secondary|Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score|NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean change from Baseline to Week 12 in weekly average of daily itch/pruritus based on the NRS was presented using mean and standard deviation (SD). Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.|Baseline and up to Week 12|ITT Population|||Scores on a scale||Standard Deviation|Mean
1310634|NCT02564055|Primary|Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population|The IGA is a clinical tool for assessing the current state/severity of a participant’s AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. The percentage of participants who have an IGA score of clear or almost clear at Week 12 and a minimum 2 grade improvement from Baseline to Week 12 in IGA score was presented. . The analysis was performed on ITT Population which comprised of all randomized participants.|Baseline and up to Week 12|ITT Population. Only those participants with data available at specified data points were analyzed.|||Percentage of participant|||Number
1310635|NCT02564042|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|"Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or Any time post-screen, a participant is categorized as Abnormal if >=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title)."|Up to Week 14|Safety Population|||Participants|||Number
1310636|NCT02564042|Secondary|Number of Participants With Vital Signs of Clinical Importance|The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
1310637|NCT02564042|Secondary|Change From Baseline in Temperature|Temperature was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||degree Celsius||Standard Deviation|Mean
1310638|NCT02564042|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||beats per minute||Standard Deviation|Mean
1324759|NCT02196714|Secondary|Change in QT Interval From Pre-dose to 12 Hours Post Dose|Change in QT Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
1310640|NCT02564042|Secondary|Change From Baseline in Immunophenotype Data|Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 12|Safety Population|||GI/L||Standard Deviation|Mean
1310641|NCT02564042|Secondary|Number of Participants With Immunophenotyping Data Outside the Reference Range|Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 12|Safety Population|||Participants|||Number
1310642|NCT02564042|Secondary|Number of Participants With Ig Data Outside the Reference Range|Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 12|Safety Population|||Participants|||Number
1310643|NCT02564042|Secondary|Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels|Blood samples were collected for the evaluation of change in IgA, IgG and IgM levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 12|Safety Population|||g/L||Standard Deviation|Mean
1310644|NCT02564042|Secondary|Number of Participants With Hematology Data of Clinical Importance|Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
1310645|NCT02564042|Secondary|Number of Participants With Chemistry Data of Potential Clinical Importance|Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
1310646|NCT02564042|Secondary|Change From Baseline in Erythrocyte Count|Blood samples were collected for the evaluation of change in erythrocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Tetra unit/L (TI/L)||Standard Deviation|Mean
1310647|NCT02564042|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume|Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Femtoliter (fL)||Standard Deviation|Mean
1310648|NCT02564042|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level|Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Picogram (pg)||Standard Deviation|Mean
1310649|NCT02564042|Secondary|Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)|Blood samples were collected for the evaluation of change in Hgb levels and MCHC from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||G/L||Standard Deviation|Mean
1310650|NCT02564042|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected for the evaluation of change in hematocrit levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
1310760|NCT02561195|Secondary|Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination 4||within 14 days of Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310651|NCT02564042|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count|Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Giga unit/liter (GI/L)||Standard Deviation|Mean
1310652|NCT02564042|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels|Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||millimoles (mmol)/L||Standard Deviation|Mean
1310653|NCT02564042|Secondary|Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.|Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||micromoles (µmol)/L||Standard Deviation|Mean
1310654|NCT02564042|Secondary|Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.|Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||International Units (IU)/L||Standard Deviation|Mean
1310655|NCT02564042|Secondary|Change From Baseline in Albumin and Protein Level|Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||grams/liter (g/L)||Standard Deviation|Mean
1310656|NCT02564042|Secondary|Number of Participants With Reported Local Tolerability Scores|The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
1310657|NCT02564042|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.|Up to Week 16|Safety Population|||Participants|||Number
1310658|NCT02564042|Secondary|Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of participants|||Number
1310659|NCT02564042|Secondary|Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit|The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
1314917|NCT02434497|Secondary|Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline HDL-C|participants|95% Confidence Interval|Geometric Mean
1310660|NCT02564042|Secondary|Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit|A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
1310661|NCT02564042|Secondary|Mean Change in PGA Score From Baseline to Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
1310662|NCT02564042|Secondary|PGA Scores at Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
1310663|NCT02564042|Secondary|Mean Change in PASI Score From Baseline to Each Study Visit|The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
1310664|NCT02564042|Secondary|Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit|The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of BSA||Standard Deviation|Mean
1310665|NCT02564042|Secondary|Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 16|mITT Population|||Percentage of participants|||Number
1310666|NCT02564042|Secondary|Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of participants|||Number
1310761|NCT02561195|Secondary|Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination 4||within 14 days of Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1316374|NCT02393547|Primary|Post Cessation Weight Change|change in weight from baseline to week 12|12 weeks|subjects (n=10) who met criteria for prolonged smoking abstinence at week 12|||kg||Standard Deviation|Mean
1310667|NCT02564042|Secondary|Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit|The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with >=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of participants|||Number
1310668|NCT02564042|Primary|Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12|The PGA is a clinical tool for assessing the current state/severity of a participant’s psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual ‘average’ of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008.|Baseline and up to Week 12|mITT Population|||Percentage of participants|||Number
1310669|NCT02564029|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|The all causalities treatment-emergent AEs by System Organ Class and Preferred Term in >5% of subjects. AEs included serious AEs and non-serious AEs.|19 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
1310670|NCT02564029|Secondary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings||17 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
1310671|NCT02564029|Secondary|Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate||17 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
1310672|NCT02564029|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.|17 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
1310673|NCT02564029|Secondary|Plasma Concentration of Lorazepam||1, 2, 3, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||ng/mL||Standard Deviation|Mean
1310674|NCT02564029|Secondary|Time for Cmax (Tmax) of PF-06372865||1, 2, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||hour||Full Range|Median
1310675|NCT02564029|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865||Pre-dose, 1, 2, 3, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1310676|NCT02564029|Secondary|Maximum Plasma Concentration (Cmax) of PF-06372865||1, 2, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1310677|NCT02564029|Secondary|The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)|Complete suppression: SPR = 0 in all three eye conditions at the same time point. Partial response: A reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response: Did not meet complete suppression or partial response definitions.|Pre-dose, 1, 2, 4 and 6 hours post-dose|Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.|||Percentage of participants|||Number
1310678|NCT02564029|Secondary|The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition|The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.|Pre-dose, 1, 2, 4 and 6 hours post-dose|Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.|||Units on a scale||Standard Error|Least Squares Mean
1310679|NCT02564029|Primary|The Standardized Photosensitivity Range (SPR) in the Subject’s Most Sensitive Eye Condition|The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.|Pre-dose, 1, 2, 4 and 6 hours post-dose|Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.|||Units on a scale||Standard Error|Least Squares Mean
1310680|NCT02563899|Secondary|Percentage of Participants With 2-point Decrease From Baseline to Day 15 in HDSS Score|HDSS is a 4-point scale which used to assess the impact of disease. The scores are define as, 1- My (underarm) sweating is never noticeable and never interferes with my daily Activities; 2- My (underarm) sweating is tolerable but sometimes interferes with my daily activities; 3- My (underarm) sweating is barely tolerable and frequently interferes with my daily activities; 4- My (underarm) sweating is intolerable and always interferes with my daily activities. Average score of both left and right underarms were used for analysis. The possible average score range from 1 (minimum) to 4 (maximum). Increase in score on scale represents worsening. Assessments conducted at Day 1, pre-dose time point (average pre-dose measurements for both left and right underarm measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 Visit Value minus Baseline values. Percentage of participants with 2-point decrease from Baseline to Day 15 in HDSS score were reported.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1310681|NCT02563899|Secondary|Change in Hyperhidrosis Disease Severity Scale (HDSS) at Day 15|The HDSS is a 4-point scale which used to assess the impact of disease. The scores were define as, 1- My (underarm) sweating is never noticeable and never interferes with my daily Activities; 2- My (underarm) sweating is tolerable but sometimes interferes with my daily activities; 3- My (underarm) sweating is barely tolerable and frequently interferes with my daily activities; 4- My (underarm) sweating is intolerable and always interferes with my daily activities. Average score of both left and right underarms were used for analysis. The possible average score range from 1 (minimum) to 4 (maximum). The reduction in score on the scale presents betterment and increase in the score represents worsening. Assessments conducted at Day 1, pre-dose time point (average pre-dose measurements for both left and right underarm measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 Visit Value minus Baseline values.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Score on Scale||Standard Error|Mean
1310682|NCT02563899|Secondary|Percentage of Participants With Cut-points for Percent Change From Baseline in Sweat Production at Day 15|Amount of sweat produced was determined by gravimetry analysis for axilla. Filter paper in a sealed container was weighed. After drying the axillary surface, the filter paper was removed from the container and applied to the axilla. The paper was covered with plastic wrap and tape around the edges with paper tape. The filter paper was left in contact with the axilla for a period of 5 minutes as measured by a stopwatch. The filter paper was then replaced in the sealed container and re-weighed. Rate of sweat production was calculated in milligrams/minute. Assessments conducted at Day 1, Pre-dose time point (average pre-dose measurements for both left and right measurements) were considered as Baseline values. Percent change from Baseline= 100 x ( Day 15 value – Baseline value) / Baseline value. The percentage of participants with cutpoints (-30%, -50, -75%) for percent change from Baseline in sweat production were presented.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1310683|NCT02563899|Secondary|Change From Baseline in Amount of Sweat Produced at Day 15|Amount of sweat produced was determined by gravimetry analysis for axilla. Filter paper in a sealed container was weighed. After drying the axillary surface, the filter paper was removed from the container and applied to the axilla. The paper was covered with plastic wrap and tape around the edges with paper tape. The filter paper was left in contact with the axilla for a period of 5 minutes as measured by a stopwatch. The filter paper was then replaced in the sealed container and re-weighed. Rate of sweat production was calculated in milligrams/minute (mg/min). Participants remained at rest for 20-30 minute before the measurements in order to reduce external interference. Measurements were carried out in a climate-controlled environment (21-24°C). Assessments conducted at Day 1, Pre-dose time point (average pre-dose measurements for both left and right measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 value minus Baseline value.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population comprised of participants receiving study medication and having at least 1 post baseline visit. Only those participants available at the specified time points were analyzed.|||mg/ min||Standard Deviation|Mean
1310684|NCT02563899|Primary|Number of Participants With Local Tolerability Assessment Score Over 28 Days|The investigator or designated evaluator assessed skin tolerability at each visit using the 5-point tolerability scale. Tolerability of the topical application was assessed and scored as, 0- none (no evidence of local intolerance), 1-mild (minimal erythema and/or edema, slight glazed appearance), 2-moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), 3-severe (erythema, edema glazing with fissures, few vesicles or papules), 4- very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions).|Days 1, 2, 4, 5, 6, 7, 8, 9, 10, 13, 14, 15, 16, and 23|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
1310685|NCT02563899|Primary|Number of Participants With Abnormal Values of Potential Clinical for Vital Signs|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 28 days|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
1310686|NCT02563899|Primary|Number of Participants With Urinalysis Abnormalities of Potential Clinical Importance at Any Time on Treatment|The urinalysis parameters analyzed were specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at any visit were reported.|Up to Day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
1310963|NCT02555722|Primary|Limbal Hyperemia - Fanfilcon A Lens (Test)|Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310687|NCT02563899|Primary|Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance at Any Time on Treatment.|The hematology parameters analyzed were basophils, eosinophils, erythrocyte mean corpuscular hemoglobin concentration, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets, and reticulocytes. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.|Up to Day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
1310688|NCT02563899|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance at Any Time on Treatment|The clinical chemistry parameters analyzed were albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, bicarbonate, blood urea nitrogen, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, potassium, sodium, total and direct bilirubin, total protein, uric acid. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important clinical chemistry findings at any visit were reported.|Up to day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
1310689|NCT02563899|Primary|Number of Participants With Abnormal Values of Potential Clinical for Electrocardiogram (ECG)|Single 12-lead ECGs was obtained at Day 1, Day 14 and Day 28 during the study. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Up to Day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
1310690|NCT02563899|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Over a period of 28 days|Safety population of study number 202093, LHH117157 (Cohort B) and AC4112008 were used to report AEs.|||Participants|||Count of Participants
1310691|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Duration of the Zero Order Process and Lag Time for the First Order Absorption Process (ALAG1)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for ALAG1 was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) x 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population PK parameter analysis.|||h||Standard Error|Mean
1310692|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Absolute Plasma Bioavailability Following Administration to Axilae (FA) Fraction of the Bioavailable Drug Absorbed Through a Zero Order Process (F2 [FIXED])|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for FA and F2 (FIXED) was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) x 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population PK parameter analysis.|||Ratio||Standard Error|Mean
1310693|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Absorption Rate Constant (Ka)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for Ka was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) X 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.|||1/h||Standard Error|Mean
1316375|NCT02393209|Secondary|TAK-117 Plasma Concentrations When Administered 1 Day After Docetaxel in Phase 2||1 day post docetaxel dose|Data was not analyzed as Phase 2 of study was cancelled.||||||
1310694|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Elimination Clearance (CL) and Inter-compartmental Clearance (Q)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for CL and Q was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) X 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.|||L/h||Standard Error|Mean
1310695|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Volume of Distribution in Central Compartment (V1) and Volume of Distribution in Peripheral Compartment (V2)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for V1 and V2 was reported as mean (estimate) with relative standard error (RSE). RSE= (Standard error of the estimate/ Final parameter estimate) X 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.|||Litre (L)||Standard Error|Mean
1310696|NCT02563899|Primary|Mean Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Across All Treatments (0-t) and AUC Over the Dosing Interval (0-tau) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. Geometric mean of log-transformed values of AUC were reported.|Day 14 to Day 16|Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1310697|NCT02563899|Primary|Terminal Phase Half-life (t1/2) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Derivation of t1/2 was planned. However, the parameter could not be derived for any of the participant included in the study because of insufficient data in the elimination phase (< 3 data points, coefficient of determination (R^2) was not adequate).|Day 14 to Day 16|Pharmacokinetic Concentration Population||||||
1310698|NCT02563899|Primary|Mean Terminal Plasma Elimination Rate Constant (Lambda Z) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Derivation of lambda-Z was planned. However, the parameter could not be derived for any of the participant included in the study because of insufficient data in the elimination phase (< 3 data points, coefficient of determination (R^2) was not adequate).|Day 14 to Day 16|Pharmacokinetic Concentration Population||||||
1310699|NCT02563899|Primary|Mean Time to Reach Cmax (Tmax) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Tmax was determined directly from the concentration-time data.|Day 14 to Day 16|Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Standard Deviation|Mean
1310700|NCT02563899|Primary|Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) After Repeat Dosing of Umeclidinium|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Cmax and Ctau was determined directly from the concentration-time data.|Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose)|Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1310701|NCT02563899|Primary|Mean Plasma Concentration After Repeat Dosing of Umeclidinium|Pharmacokinetic blood sampling was done at the following time points: Day 12 (pre-dose), Day 13 (pre-dose), Day 14 (pre-dose), Day 15 (3 hours [h], 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Approximately 3 ml of blood was taken at each timepoint. Mean and standard deviation of the umeclidinium concentration was reported. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day 12 to Day 16|Pharmacokinetic Concentration Population defined as all participants in the Safety population for whom at least one pharmacokinetic sample was obtained and analyzed. Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093)|||picogram per millilitre (pg/ml)||Standard Deviation|Mean
1310702|NCT02563834|Secondary|Myocardial Perfusion Rate|PET measure of total myocardial perfusion (blood flow)|4 Hours||||ml/min/100g||Standard Error|Mean
1310703|NCT02563834|Secondary|Myocardial Oxidation Rate|PET measure of total oxidation rate|4 Hours||||ml/min/100g||Standard Error|Mean
1310704|NCT02563834|Primary|Myocardial Fatty Acid Uptake Rate|PET measure of fatty acid uptake rate|4 Hours||||umol/min/100g||Standard Error|Mean
1351305|NCT01780922|Primary|Glutathione Peroxidase (GPx) Activity in Red Blood Cells||0, 2, 4, 8, 24 h||||mU/mg HgB||Standard Error|Mean
1310705|NCT02563106|Primary|Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.|Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B [or their respective genes, tcdA and/or tcdB], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.|Day 1 to the 4 week Follow-up Visit.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.|||Participants|||Count of Participants
1310706|NCT02563093|Secondary|Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1310707|NCT02563093|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Participants|||Number
1310708|NCT02563093|Secondary|Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination.|Day 0 (Pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Participants|||Number
1310709|NCT02563093|Secondary|Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1310710|NCT02563093|Primary|Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|"Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.~A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set."|Day 0 up to Day 7 post-vaccination|The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to < 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) group in the Safety Analysis Set.|||Participants|||Number
1310711|NCT02562989|Primary|Intra-subject Test-Retest (T-RT) Variability of Standardized Uptake Value Ratio (SUVR) in Brain Regions of Interest|"For each AD/MCI participant receiving 2 doses of MK-6240, the SUVR (60-90 min) during initial dose (SUVR_1) was compared to the SUVR (60-90 min) during the second dose (SUVR_2) to determine the percent test-retest (T-RT) variability of the SUVR (60-90 min) for each brain ROI.~T-RT variability = (absolute value (SUVR_1 – SUVR_2) / average SUVR) * 100. If T-RT variability = 0, indicates no variability between SUVR_1 and SUVR_2."|Up to 16 weeks following initial dose of [18F]MK-6240|Includes only elderly AD/MCI participants (Part 2); per protocol, young (Part 1) and elderly (Part 2) healthy participants did not receive retest scan. Of the 6 AD/MCI participants, only 2 received T-RT scans. In one participant, motion artifacts prevented T-RT analysis. For the one participant included, T-RT scans were separated by 16 weeks.|||Percent|||Number
1310712|NCT02562989|Primary|Standardized Uptake Value Ratio (SUVR) of [18F]MK-6240 in Brain Regions of Interest|"As a surrogate of regional [18F[MK-6240 tracer distribution volume (VT), mean standardized uptake value ratios (SUVRs), were calculated for specific brain regions of interest (ROIs) in healthy elderly as well as AD/MCI elderly participants in Part 2 of the study. Calculated using calibrated PET scan images from each participant, SUVR is the relative ratio of pixel intensities at a specific brain ROI compared to a reference region (RR; cerebellar cortex, for this study). For an individual participant, the average SUVR for each brain ROI is calculated starting at 60 minutes and ending at 90 minutes following [18F]MK-6240 administration to quantify tracer retention; referred to as SUVR (60-90min).~An SUVR (60-90 min) < 1 indicates decreased tracer retention at brain ROI relative to RR.~An SUVR (60-90 min) = 1 indicates no difference in tracer retention at brain ROI relative to RR.~An SUVR (60-90 min) > 1 indicates increased tracer retention at brain ROI relative to RR."|From 60 to 90 minutes following [18F]MK-6240 administration|The analysis population included healthy elderly as well as AD/amnesic MCI participants enrolled in Part 2 of this study. As per study protocol, participants enrolled in Part 1 did not receive testing for SUVR (60-90 min) and, as a result, were not included in the analysis population.|||SUVR (60-90 min)||Standard Deviation|Mean
1310757|NCT02561572|Primary|State-Trait Anxiety Inventory Score|Patients completed the six item short form of the State-Trait Anxiety Inventory (STAI-S6) in order to assess baseline anxiety levels prior to any intervention. The STAI-S6 is a standardised short form of the 40-item Spielberger State-Trait Anxiety Inventory that has three anxiety-present and three anxiety-absent questions (Table 1). Scores from the STAI-S6 are prorated up to allow comparison with the full version of the questionnaire, with scores ranging from 20 (low anxiety) to 80 (high anxiety). The STAI-S6 has been shown to correlate well with the full version, [12] but is much quicker for participants to complete.|30 minutes after intervention||||units on a scale||Inter-Quartile Range|Median
1310713|NCT02562989|Primary|Organ Effective Dose of [18F]MK-6240|Mean organ ED of [18F]MK-6240 was calculated from WB PET scans of healthy young participants included in Part 1 of study. Organ ED, reported as micrograys (µGy) / MBq, is a measure of organ-specific radiation exposure risk. Following [18F]MK-6240 PET tracer administration, organ-specific TACs and radioactivity residence times were utilized to calculate organ ED for specific organs of the body.|Up to approximately 5 hours following [18F]MK-6240 administration|The analysis population included only healthy young participants enrolled in Part 1 of this study (N=3). As per study protocol, participants enrolled in Part 2 did not receive testing for effective dose of [18F]MK-6240 and, as a result, were not included in the analysis population.|||µGy / MBq||Standard Deviation|Mean
1310714|NCT02562989|Primary|Effective Dose of [18F]MK-6240|Mean effective dose (ED) of [18F]MK-6240 was calculated from whole-body (WB) PET scans of healthy young participants included in Part 1 of study. ED, reported as microsieverts (µSv) / megabecquerel (MBq), is a measure of WB radiation exposure risk that accounts for differences in individual organ exposure and organ susceptibility to ionizing radiation. Following [18F]MK-6240 PET tracer administration, organ-specific time-activity curves (TACs) and radioactivity residence times were utilized to calculate exposure risk for individual organs. These values calculated for individual organs were then entered into a human biodistribution model to determine ED of [18F]MK-6240.|Up to approximately 5 hours following [18F]MK-6240 administration|The analysis population included only healthy young participants enrolled in Part 1 of this study (N=3). As per study protocol, participants enrolled in Part 2 did not receive testing for effective dose of [18F]MK-6240 and, as a result, were not included in the analysis population.|||µSv / MBq||Standard Deviation|Mean
1310715|NCT02562989|Primary|Number of Participants Who Discontinued Study Due to an AE|The number of participants discontinuing study due to an AE was monitored.|Part 1: Up to 5 weeks; Part 2: up to 16 weeks|All participants as treated, consisting of all participants who received at least 1 dose of [18F]MK-6240|||Participants|||Number
1310716|NCT02562989|Primary|Number of Participants With Adverse Events (AEs)|The number of participants experiencing an adverse event (AE) was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Part 1: Up to 5 weeks; Part 2: up to 16 weeks|All participants as treated, consisting of all participants who received at least 1 dose of [18F]MK-6240|||Participants|||Number
1310717|NCT02562521|Secondary|Wisconsin Predicting Patient’s Relapse Questionnaire|Items from the Wisconsin Predicting Patient’s Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.|Month 6|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||units on a scale||Standard Deviation|Mean
1310718|NCT02562521|Secondary|Wisconsin Predicting Patient’s Relapse Questionnaire|Items from the Wisconsin Predicting Patient’s Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.|Baseline|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||units on a scale||Standard Deviation|Mean
1310719|NCT02562521|Secondary|Number of People Who Quit Smoking at 6 Months|Smoking cessation is operationally defined as successfully quitting smoking at 6 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 6|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
1310720|NCT02562521|Secondary|Number of People Who Quit Smoking at 5 Months|Smoking cessation is operationally defined as successfully quitting smoking at 5 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 5|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
1310721|NCT02562521|Secondary|Number of People Who Quit Smoking at 4 Months|Smoking cessation is operationally defined as successfully quitting smoking at 4 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 4|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
1310758|NCT02561195|Secondary|Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)||From Vaccination 4 up to 6 months after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1351306|NCT01780922|Primary|Superoxide Dismutase (SOD) Activity in Red Blood Cells||0, 2, 4, 8, 24 h||||mU/mg HgB||Standard Error|Mean
1310722|NCT02562521|Secondary|Number of Participants Who Quit Smoking at 3 Months|Smoking cessation is operationally defined as successfully quitting smoking at 3 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 3|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
1310723|NCT02562521|Secondary|Number of Participants Who Quit Smoking at 2 Months|Smoking cessation is operationally defined as successfully quitting smoking at 2 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 2|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
1310724|NCT02562521|Primary|Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks|A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking.|6 weeks|These analyses are conducted for the subset of dining hall employees who reported being smokers.|||Participants|||Count of Participants
1310725|NCT02562521|Primary|Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks|A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt.|6 weeks|These analyses are conducted for the subset of dining hall employees who reported being smokers.|||Participants|||Count of Participants
1310726|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants(Pts) who received at least 1 dose of study drug & had baseline & post-baseline data for WPAI-PSO impairment in activities performed outside work.~mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, pts who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310727|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO work impairment score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310728|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO presenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310729|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310730|NCT02561806|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score|"The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug & had baseline & post-baseline EQ-5D 5L UK population-based index score measurement.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310731|NCT02561806|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS|The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||mm||95% Confidence Interval|Least Squares Mean
1310732|NCT02561806|Secondary|"Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) Bolt On Psoriasis (PSO) -Index"|"The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health).~ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L Bolt On PSO-Index.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310733|NCT02561806|Secondary|Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)|"The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PatGA.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310734|NCT02561806|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF36 MCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310735|NCT02561806|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF36 PCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310736|NCT02561806|Secondary|Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.|"The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for HADS anxiety subscale.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310737|NCT02561806|Secondary|Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale|"The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for HADS depression subscale.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310738|NCT02561806|Secondary|Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1)|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life."|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1310739|NCT02561806|Secondary|Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)|"Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for skin pain VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||mm||95% Confidence Interval|Least Squares Mean
1310740|NCT02561806|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS)|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Itch NRS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310741|NCT02561806|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score|"NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who had nail psoriasis at baseline & received at least 1 dose of study drug and had baseline & post-baseline NAPSI measurement.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310742|NCT02561806|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score|"The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who had psoriasis in scalp region at baseline & received at least 1 dose of study drug & had baseline & post-baseline PSSI data.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310743|NCT02561806|Secondary|Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score|"The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants(Pts) who had psoriasis in palmoplantar regions at baseline & received at least 1 dose of study drug & had baseline & post-baseline PPASI data.~mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, Pts who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
1310759|NCT02561195|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (AEs)||From Vaccination 4 up to 28 days after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310744|NCT02561806|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis|"The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.~ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug & had a baseline & post-baseline measurement for BSA affected by Ps.~mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||Percent Body Surface Affected||95% Confidence Interval|Least Squares Mean
1310745|NCT02561806|Secondary|Percentage of Participants With a sPGA (0) Remission|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for sPGA (0). Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1310746|NCT02561806|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline|"The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1310747|NCT02561806|Secondary|Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1310748|NCT02561806|Secondary|Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1310749|NCT02561806|Primary|Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 12|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1310750|NCT02561702|Primary|Number of Participants With a Decrease in Cramp Intensity|Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp intensity of the right hamstring was reported by the subject on a scale of 1-10 with 1 being weak and 10 being severe.|120 minutes||||participants|||Number
1310751|NCT02561702|Primary|Number of Participants With a Decrease in Cramp Duration|Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp duration in seconds of the right hamstring was used.|120 minutes||||participants|||Number
1310752|NCT02561572|Secondary|Pain Score||24 h postop|Unable to collect data on wards after PACU discharge.||||||
1310753|NCT02561572|Secondary|Pain Score in the Postanaesthetic Care Unit (PACU)|The number of patients experiencing moderate/severe pain in PACU.|Immediately postop||||Participants|||Count of Participants
1310754|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV)||24 h postop|Unable to collect data on wards after discharge from PACU||||||
1310755|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)||Within 30 minutes of surgery||||Participants|||Count of Participants
1310762|NCT02561195|Secondary|Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 8, 30, Month 6, 12, 18, 24, 30 and 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310763|NCT02561195|Secondary|Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 30, Month 6, 12, 18, 24, 30 and 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310764|NCT02561195|Secondary|Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310765|NCT02561195|Secondary|Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310766|NCT02561195|Secondary|Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310767|NCT02561195|Secondary|Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||day 8, 30; month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310768|NCT02561195|Secondary|Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310769|NCT02561195|Secondary|Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310770|NCT02561195|Secondary|Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310771|NCT02561195|Secondary|Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
1310772|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310773|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Toxin A antibodies were measured using neutralization assay.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310774|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Toxin A antibodies were measured using neutralization assay.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310829|NCT02559622|Secondary|Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52|Fasting Insulin, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Fasting Insulin of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||micro units per millilitre (uU/mL)||95% Confidence Interval|Mean
1310775|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1310776|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Toxin B antibodies were measured using neutralization assay.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1310777|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Toxin A antibodies were measured using neutralization assay.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1310778|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|GMFR for toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
1310779|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
1310780|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. Here, N= number of participants evaluable for this outcome measure.|||fold rise||95% Confidence Interval|Geometric Mean
1310781|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Geometric mean fold rise (GMFR) in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
1310782|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
1310783|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
1311350|NCT02545868|Secondary|MRI Parameters: T1 Unenhancing Lesion Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
1310784|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
1310785|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|Geometric mean concentration (GMC) of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. Confidence interval (CI) for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
1310786|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310787|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Toxin B antibodies were measured using neutralization assay.|Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310788|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Toxin A antibodies were measured using neutralization assay.|Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310789|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1310790|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Toxin B antibodies were measured using neutralization assay.|Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1310791|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13|Toxin A antibodies were measured using neutralization assay.|Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310792|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 6 months after Vaccination 3 (Month 12)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
1310793|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 6 months after Vaccination 3 (Month 7)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
1310794|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 28 days after Vaccination 3 (Day 208)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
1310795|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 28 days after Vaccination 3 (Day 58)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
1310796|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310797|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310798|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310799|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310800|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310801|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 degree Celsius (C)), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 7 days after Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310802|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310803|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310804|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days after Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310805|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days After Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310806|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days After Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310807|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2)(interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 7 days After Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1310808|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7|Toxin A and toxin B antibodies were measured using neutralization assay.|Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310830|NCT02559622|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52|Fasting plasma glucose (FPG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for FPG at week 4, 12, 24 and 52 for each arm, respectively."|||mg/dL||95% Confidence Interval|Mean
1310809|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310810|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7|Toxin B antibodies were measured using neutralization assay.|Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310811|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37|Toxin B antibodies were measured using neutralization assay.|Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310812|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7|Toxin A antibodies were measured using neutralization assay.|Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310813|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37|Toxin A antibodies were measured using neutralization assay.|Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1310814|NCT02560753|Other Pre-specified|Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New|Number of participants with treatment related adverse events (AEs) as assessed by analysis of adverse events, including symptoms, and abnormal findings on physical and neurological examinations, and standard labs.|after 14 days of treatment|3 mg group:A subject Dc'd prior to the EOT & another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject’s EOT data.|||participants|||Number
1310815|NCT02560753|Secondary|Change From Baseline in the Total Score of the 11-item Alzheimer’s Disease Assessment Scale – Cognitive Subscale|The 11-item Alzheimer’s Disease Assessment Scale (ADAS-Cog 11) is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. The score can range between 0 and 70. A higher score indicates more cognitive impairment. A positive change in the score indicates cognitive worsening. The minimum severity score is 0 and the maximum severity score is 70.|after 14 days of treatment|3 mg group:A subject Dc'd prior to the EOT & another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject’s EOT data.|||score on a scale||Standard Deviation|Mean
1310816|NCT02560753|Secondary|Change From Baseline in the Score of the Digit Symbol Substitution Test|The digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment. Scores on the DSST range from 0-93.|after 14 days of treatment|3 mg group:A subject Dc'd prior to the EOT & another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject’s EOT data.|||score on a scale||Standard Deviation|Mean
1310817|NCT02560753|Primary|The Effect of Treatment With T3D-959 on Changes in Resting State Blood Oxygen Level Dependent (BOLD) Signal in Functional Magnetic Resonance Imaging (fMRI) of the Brain Areas Associated With Cognitive Tasks.|Changes in BOLD fMRI parameters such as GoF (see Study Description) over the course of two weeks of treatment, were obtained in this study. BOLD fMRI has been used in cross sectional and longitudinal studies of Alzheimer’s subjects, for instance in the Alzheimer’s Disease Neuroimaging Initiative studies. However, no studies monitoring Default Mode Networks measured parameters such as GoF, in the context of an effective AD therapeutic, as a result it is difficult to interpret the observed small changes listed in BOLD fMRI parameters obtained in this trial. Instead the changes in the listed BOLD fMRI parameters (EOT – BL) are reported without interpretation. These values represent changes in fMRI connectivity patterns over time and are unitless.|after 14 days of treatment||||unitless||Standard Deviation|Mean
1310856|NCT02558829|Other Pre-specified|Agreement (Positive/Negative) for MAC Core Study Part and MAC Repeatability Extension (Amendment 1)|Amendment no 1 (repeatability extension) had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study. Pre-defined MAC cut-off point GH: 2.8 ng/mL. Agreements were calculated with two-sided 95% confidence intervals.|90 minutes|All subjects included in the modified intention-to-treat (mITT) analysis who also participated in the repeatability extension, i.e. N=34 (comprising 13 Group A, 12 Group B, and 9 Group C subjects).|||Participants|||Count of Participants
1310818|NCT02560753|Primary|Change From Baseline (End of Treatment - Baseline) for FDG-PET Imaging With Whole Brain and White Matter as Reference Region|Changes in relative brain glucose metabolism (delta R CMRgl) were measured by FDG-PET. At each time point, a ratio of the PET reading in a pre-defined region of interest (sROI), known to be affected by AD, and in a reference region (RR) that is spared in AD, is determined. This ratio is defined as “sROI index” (spared region). A second RR, brain white matter (WM), was also used in this calculation: sROI index” (WM) value. delta sROI is defined as change in the sROI index values, over the treatment period. In this study we are looking for changes in delta sROI with increasing doses of T3D-959. Dose dependent changes in delta sROI (AD spared) are compared to those observed with the WM as the RR: delta sROI (WM). Dose related changes in delta sROI suggests T3D-959 is entering the brain and effecting glucose metabolism in a dose dependent fashion.|after 14 days of treatment|Both + & - values for delta sROI represent “better outcomes” with regard to the demonstrating pharmacological activity of a PPAR delta, such as T3D-959, in the brain. It is unknown at this time, both from this presented data and from the literature, whether the pharmacological action of a PPAR delta agonist will translate to better outcomes in AD.|||ratio||Standard Deviation|Mean
1310819|NCT02560584|Secondary|Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy|In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.|At time of cystoscopy procedure|Number of patients with histologically confirmed CIS|||Participants|||Count of Participants
1310820|NCT02560584|Secondary|Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination||At time of cystoscopy procedure|This is a within patient control trial, where the white light (WL) cystoscopy was the comparator. Enrolled participants received a WL and blue light (BL) surveillance examination after Cysview instillation. Operating room (OR) cystoscopy in WL and BL was performed for patients with suspicion of recurrence after surveillance cystoscopy.|||Participants|||Count of Participants
1310821|NCT02560584|Primary|Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy|In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured.|At time of cystoscopy procedure|Patients with histologically confirmed malignancy|||Participants|||Count of Participants
1310822|NCT02559622|Secondary|Change From Baseline in Leptin at Week 4, 12, 24 and 52|Leptin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Leptin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively"|||ng/mL (nanogram per milliliter)||95% Confidence Interval|Mean
1310823|NCT02559622|Secondary|Change From Baseline in Adiponectin at Week 4, 12, 24 and 52|Adiponectin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Adiponectin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively."|||ug/mL||95% Confidence Interval|Mean
1310824|NCT02559622|Secondary|Change From Baseline in Triglycerides, Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB) at Week 4, 12, 24 and 52|Triglycerides, Total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB), soluble biomarkers of impaired lipid metabolism were determined in fasting blood samples to evaluate the effect of secukinumab on impaired lipid metabolism.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Triglycerides, Total cholesterol, LDL, HDL, ApoA-1 and ApoB of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively."|||mg/dL||95% Confidence Interval|Mean
1310825|NCT02559622|Secondary|Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52|Sex hormone-binding globulin (SHBG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for SHBG of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||nanomole per Liter (nmol/L)||95% Confidence Interval|Mean
1310826|NCT02559622|Secondary|Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52|Hemoglobin A1c (glycated hemoglobin), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Hemoglobin A1c of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||millimole per mole of Haemoglobin||95% Confidence Interval|Mean
1310827|NCT02559622|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52|HOMA insulin resistance, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for HOMA insulin resistance of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||Insulin Resistance Index||95% Confidence Interval|Mean
1310828|NCT02559622|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52|Homeostatic Model Assessment (HOMA) beta-cell function, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for HOMA beta-cell function of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||Percentage||95% Confidence Interval|Mean
1310884|NCT02557698|Secondary|Skin Surface pH at the Right Lateral Lower Leg|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 14 +/- 2||||non-dimensional||Standard Deviation|Mean
1310831|NCT02559622|Secondary|Change From Baseline in Chemokine (C-c Motif) Ligand 5 (CCL5), Monocyte Chemoattractant Protein 1 (MCP-1) and Macrophage Inflammatory Proteins (MIP) 1 Alpha and 1 Beta at Week 4, 12, 24 and 52|Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha (1A) and 1 beta (1B), soluble biomarkers of systemic inflammation were determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for CCL5, MCP-1, MIP-1A and MIP-1B at week 4, 12, 24 and 52 for each arm, respectively."|||picograms per milliliter (pg/mL)||95% Confidence Interval|Mean
1310832|NCT02559622|Secondary|Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52|S100 calcium-binding protein B (S100B-protein), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for S100B-protein at week 4, 12, 24 and 52 for each arm, respectively."|||Microgram per Liter (ug/L)||95% Confidence Interval|Mean
1310833|NCT02559622|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52|High sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for hsCRP at week 4, 12, 24 and 52 for each arm, respectively."|||Milligrams per deciliter (mg/dL)||95% Confidence Interval|Mean
1310834|NCT02559622|Secondary|Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52|Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.|Baseline, Week 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for MRI sub-study at week 52 for each arm, respectively. MRI was applied in a sub-study population of 33 participants."|||mm^2||95% Confidence Interval|Mean
1310835|NCT02559622|Secondary|Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12|Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.|Baseline, Week 12|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for MRI sub-study at week 12 for each arm, respectively. MRI was applied in a sub-study population of 33 participants."|||millimeter square (mm^2)||95% Confidence Interval|Mean
1310836|NCT02559622|Secondary|Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52|Regional arterial pulse wave velocity (PWV) was directly related to arterial stiffness and was defined as the time it takes for the blood pressure wave to travel from a proximal site to a distal site (relative to the heart) divided by the distance (PWV = ∆distance/∆time [m/s]). The foot of the arterial pulse wave was being recorded by using the SphygmoCor XCEL device. XCEL simultaneously measures the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand-held applanation tonometry). The foot-to-foot time between the two pressure waveforms was the time interval used in the PWV calculation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, n signifies the sum of participants for all repeated measurements during calculation of mean, evaluable for pulse wave velocity (PWV) at Week 4, 12, 24 and 52 for each arm, respectively."|||meters per second (m/s)||95% Confidence Interval|Mean
1310837|NCT02559622|Secondary|Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52|Pulse wave analysis was performed on the central aortic pressure waveform as derived by SphygmoCor XCEL from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm. The waveform derivation employs a validated generalized transfer function to convert a brachial waveform to a central waveform and has been shown to produce measurement results corresponding to measurements using intra-arterial pressure catheters. The augmentation index is derived from the waveform by determining the percentage of the central pulse pressure during systole due to wave reflection. AIx was heart-rate corrected to calculate the AIx at a heart rate of 75 bpm, i.e. AIx-75.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for pulse wave analysis at weeks 4, 12, 24 and 52 for each arm, respectively."|||Percentage change in Alx-75||95% Confidence Interval|Mean
1310838|NCT02559622|Secondary|Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52|FMD is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum – D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 mmHg for 4.5 minutes and for 4.5 minutes following deflation. A positive change in FMD constitutes an improvement in endothelial function.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for FMD at weeks 4, 12, 24 and 52 for each arm, respectively."|||Percentage change in FMD||95% Confidence Interval|Mean
1310857|NCT02558829|Other Pre-specified|Sensitivity and Specificity of the MAC, GH: 2.8 ng/mL|Exploratory evaluation of sensitivity and specificity of the MAC as performance characteristic, based on test outcome in Group A and Group D subjects.|90 minutes|All high likelihood AGHD subjects of Group A (N=38) of the mITT population as ‘true’ AGHD subjects and all healthy matching subjects of Group D (N=25) of the mITT population as ‘true’ AGHD negative subjects|||Participants|||Count of Participants
1311351|NCT02545868|Secondary|MRI Parameters: Cortical Grey Matter Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
1310839|NCT02559622|Primary|Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment|Flow Mediated Dilation (FMD) is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum – D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 millimeter of mercury (mmHg) for 4.5 minutes and for 4.5 minutes following deflation.|Week 12|"The analysis was performed in Full analysis set (FAS) population, defined as all participants from the randomized set who received at least one dose of study drug. Here, Number analyzed signifies participants evaluable for FMD at Week 12 for each arm, respectively."|||Percentage maximal increase in diameter||Standard Deviation|Mean
1310840|NCT02559414|Secondary|Endothelial Function as Measured by Its Change From Baseline to Follow-up in Activation Following the Co-culture of Platelets With Human Endothelial Cells, and the Extraction of mRNA From Human Endothelial Cells by Polymerase Chain Reaction.|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function.|14 Days|||||||
1310841|NCT02559414|Secondary|Immune Activity as Measured by the Change in Biomarkers From Baseline to Follow-up Identified Via Flow Cytometry and Hematological Analysis.|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity|14 Days|||||||
1310842|NCT02559414|Secondary|Inflammation as Measured by the Change in Biomarker From Baseline to Follow-up Identified Via Hematological Analysis.|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation|14 Days|||||||
1310843|NCT02559414|Secondary|Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min||Baseline, 14 Days||||%aggregation||Standard Error|Mean
1310844|NCT02559414|Primary|Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min|The primary objective of these analyses will be to compare the effects of aspirin versus control and clopidogrel versus control for the outcome of platelet activity. Aspirin is expected to decrease arachidonic acid-induced platelet aggregation by 50% versus control. Clopidogrel is expected to decrease ADP-induced platelet aggregation by 50% versus control.|Baseline, 14 Days||||%aggregation||Standard Error|Mean
1310845|NCT02558894|Secondary|Presence of ADAs for Tremelimumab|ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Results are reported as number of patients with detectable anti- tremelimumab antibodies satisfying each of the indicated categories. Note: 'positive' is denoted by 'pos' in some category titles.|Immunogenicity samples were collected on Day 1 (Week 0), Week 4 and Week 12, and additionally at 3 months and 6 months after the last dose (follow-up).|The ADA evaluable set included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA data and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
1310846|NCT02558894|Secondary|Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736)|ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Results are reported as number of patients with detectable anti-durvalumab antibodies satisfying each of the indicated categories. Note: 'positive' is denoted by 'pos' in some category titles.|Immunogenicity samples were collected on Day 1 (Week 0), Week 4, Week 12 and Week 24, and additionally at 3 months and 6 months after the last dose (follow-up).|The ADA evaluable set included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA data and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
1310847|NCT02558894|Secondary|PK of Tremelimumab|To evaluate PK, blood samples were collected pre- and post-dose and tremelimumab concentrations in serum were determined. On Day 1 of Cycles 1 and 4 (Weeks 0 and 12), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of tremelimumab). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3-month follow-up sample for tremelimumab was relative to the respective last dose. Results are reported as mean pre- or post-dose tremelimumab concentrations as indicated by the individual categories (1 cycle=4 weeks). Samples below lower limit of quantification were treated as missing in the analyses.|Blood samples were collected pre-dose on Day 1 (Week 0), Week 4 and Week 12, post-dose on Day 1 and Week 12, and additionally at 3 months after the last dose (follow-up).|The PK analysis set included all patients who received at least 1 dose of IP, and had PK sampling data post-dose without important deviations or events to affect PK (n=64). Only patients with data available at the timepoints of testing were included in the analyses.|||mcg/mL||Standard Deviation|Mean
1310858|NCT02558829|Secondary|ECG: Change in Heart Rate From Baseline at 60 Minutes Post-dose|During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.|60 minutes|All subjects of Group A, B, C, D in the safety population. Because of single ECGs missing, the number of participants analyzed here is lower than the number of the subjects in the SAF.|||beats per minute||Standard Deviation|Mean
1311352|NCT02545868|Secondary|MRI Parameters: Volume of T2 Lesions: White Matter Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
1310848|NCT02558894|Secondary|Pharmacokinetics (PK) of Durvalumab (MEDI4736)|To evaluate PK, blood samples were collected pre- and post-dose and durvalumab (MEDI4736) concentrations in serum were determined. On Day 1 of Cycles 1, 4 and 7 (Weeks 0, 12 and 24), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of durvalumab and within 10 minutes of end of infusion of tremelimumab [for patients receiving durvalumab plus tremelimumab]). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3-month follow-up sample for durvalumab was relative to the respective last dose. Results are reported as mean pre- or post-dose durvalumab concentrations as indicated by the individual categories (1 cycle=4 weeks). Samples below lower limit of quantification were treated as missing in the analyses.|Blood samples were collected pre-dose on Day 1 (Week 0), Week 4, Week 12 and Week 24, post-dose on Day 1, Week 12 and Week 24, and additionally at 3 months after the last dose (follow-up).|The PK analysis set included all patients who received at least 1 dose of IP, and had PK sampling data post-dose without important deviations or events to affect PK (n=64). Only patients with data available at the timepoints of testing were included in the analyses.|||Micrograms per millilitre (mcg/mL)||Standard Deviation|Mean
1310849|NCT02558894|Secondary|Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1|DCR at 3 months was defined as the percentage of patients who have a BoR of CR or PR in the first 3 months or who have demonstrated SD for a minimum interval of 13 weeks following the start of treatment. DCR at 6 months was defined as the percentage of patients who have a BoR of CR or PR in the first 6 months or who have demonstrated SD for a minimum interval of 26 weeks following the start of treatment. DCR at 12 months was defined as the percentage of patients who have a BoR of CR or PR in the first 12 months or who have demonstrated SD for a minimum interval of 52 weeks following the start of treatment. Results are reported as the percentage of patients with disease control for each of the indicated categories.|From date of first infusion until confirmed disease progression or death (up to 3 months, 6 months and 12 months)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
1310850|NCT02558894|Secondary|Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1|BoR was calculated based on the overall visit responses from each RECIST assessment. It was the best response a patient had following date of first dosing but prior to starting any subsequent cancer therapy and prior to RECIST progression or last evaluable assessment in absence of RECIST progression. Categorisation of BoR was based on RECIST using the following response categories: CR and PR for status of ‘Response’; Stable Disease (SD) ≥6 weeks, Progressive Disease (PD) and Not Evaluable (NE) for status of ‘Non-response’. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the sum of diameters of TLs taking as reference the smallest sum on study. NE was only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit. Results are reported as number of patients with BoR for each of the indicated categories.|From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Participants|||Count of Participants
1310851|NCT02558894|Secondary|Survival Status, Presented as OS Rate, at 6 Months and at 12 Months|OS was defined as the time from the date of randomisation until death due to any cause. OS rates were calculated using Kaplan-Meier estimates of the cumulative probability of survival at each indicated time period. The OS rate at 6 months and 12 months was equivalent to the percentage of patients with OS after 6 months and 12 months, respectively.|From date of first infusion until death (up to 6 months and 12 months)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
1310852|NCT02558894|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomisation until death due to any cause. Results are reported as median OS, calculated using the Kaplan-Meier technique.|From date of first infusion until death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Months||95% Confidence Interval|Median
1310853|NCT02558894|Secondary|PFS Rate at 3 Months and at 6 Months|PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. PFS rates were calculated using Kaplan-Meier estimates of the cumulative probability of PFS. The PFS rate at 3 months and 6 months was equivalent to the percentage of patients with PFS after 3 months and 6 months, respectively.|From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
1310854|NCT02558894|Secondary|Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1|PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. Results are reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.|From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Months||95% Confidence Interval|Median
1310855|NCT02558894|Primary|Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when response was first observed with no evidence of progression between the initial and CR/PR confirmation visits. Results are reported as percentage of patients with a confirmed response and percentage of patients with confirmed or unconfirmed responses (i.e., including single visit responses).|From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
1310859|NCT02558829|Secondary|Number of Participants With Any Test Emergent Adverse Event (TEAE), With Any TEAE Likely or Possibly Related, and With Any Test Emergent Severe AE|GHST (‘Test’) emergent AEs (TEAEs): AEs occurring or observed from the day of first GHST (administration of an IMP) throughout End-of-Study (EOS) visit or Early Termination, whichever occurred first. TEAEs were analyzed and compared for both GHSTs. Detailed listings are presented in the Adverse Events section. The frequencies presented in this section refer to number of subjects with any TEAE, each subject was counted only once within each category.|up to 70 days|All subjects of Group A, B, C, D in the safety population.|||Participants|||Count of Participants
1310860|NCT02558829|Secondary|Overall Agreements (Positive/ Negative) for MAC and ITT|As part of the secondary efficacy analysis, the percent of overall agreement was analyzed, using the same methodology described for the analyses for the primary efficacy variables.|90 minutes|All subjects from Groups A, B, C, D included in the modified intention-to-treat (mITT) analysis, N=140|||Participants|||Count of Participants
1310861|NCT02558829|Primary|Co-primary Efficacy Variables: Percent Positive and Percent Negative Agreement of Macimorelin-GHST (MAC) With ITT|"In the primary efficacy analysis, the estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The probability for a “Negative Agreement” equals the sum of the probability of both tests being correct (negative test results for both tests for subjects with “true non-AGHD”) and the probability of both tests being wrong (negative test results for both tests for subjects with “true AGHD”).~The performance of the GHST with Macimorelin was considered to be acceptable if the lower bound of the two-sided 95% confidence interval (or lower bound of the one-sided 97.5% confidence interval) for the primary efficacy variables was 75% or higher for ‘percent negative agreement’, and 70% or higher for the ‘percent positive agreement’.~The following cut-off values for stimulated GH levels were used: - MAC: GH: 2.8 ng/mL, - ITT: GH: 5.1 ng/mL."|90 minutes|All subjects from Groups A, B, C, D included in the modified intention-to-treat (mITT) analysis, N=140|||Participants|||Count of Participants
1310862|NCT02558790|Primary|Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score|"The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.~The change in AISRS score from baseline to endpoint (12 weeks) was calculated as the later time point score minus the earlier time point score."|Baseline and 12 Weeks||||units on a scale||Standard Deviation|Mean
1310863|NCT02558374|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups|6 months|Safety Population|||days||Standard Deviation|Mean
1310864|NCT02558374|Primary|IOP (Intraocular Pressure)|The primary efficacy outcome is mean IOP|3 months|Per-Protocol Population|||mmHg||Standard Deviation|Mean
1310865|NCT02557698|Secondary|Skin Surface pH at the Left Midvolar Forearm|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 28 +/- 3||||non-dimensional||Standard Deviation|Mean
1310866|NCT02557698|Secondary|Skin Surface pH at the Left Midvolar Forearm|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 14 +/- 2||||non-dimensional||Standard Deviation|Mean
1310867|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 28 +/- 3||||µm||Standard Deviation|Mean
1310868|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 14 +/- 2||||µm||Standard Deviation|Mean
1310869|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 28 +/- 3||||µm||Standard Deviation|Mean
1310870|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 14 +/- 2||||µm||Standard Deviation|Mean
1310871|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.~Visit 3 (day 28)"|Day 28 +/- 3||||Arbitrary Units||Standard Deviation|Mean
1310872|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.~Visit 2 (day 14)"|Day 14 +/- 2||||Arbitrary Units||Standard Deviation|Mean
1310873|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Trunk|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
1310874|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Trunk|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14)"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
1310875|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
1310876|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
1310877|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
1310878|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
1310879|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
1310880|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14)"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
1310881|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness by the investigator using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks)"|Day 28 +/- 3||||Participants|||Count of Participants
1310882|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
1310883|NCT02557698|Secondary|Skin Surface pH at the Right Lateral Lower Leg|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 28 +/- 3||||non-dimensional||Standard Deviation|Mean
1316376|NCT02393209|Secondary|T1/2: Terminal Phase Elimination Half-life (T1/2) for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
1310885|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 28 +/- 3||||µm||Standard Deviation|Mean
1310886|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 14 +/- 2||||µm||Standard Deviation|Mean
1310887|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 28 +/- 3||||µm||Standard Deviation|Mean
1310888|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 14 +/- 2||||µm||Standard Deviation|Mean
1310889|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher is SCH. Per investigational site three replicate measurements were carried out.~Visit 3 (day 28)"|Day 28 +/- 3||||Arbitrary Units||Standard Deviation|Mean
1310890|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.~Visit 2 (day 14)"|Day 14 +/- 2||||Arbitrary Units||Standard Deviation|Mean
1310891|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg.~Visit 3 (day 28)"|Day 28 +/- 3||||g/m2/h||Standard Deviation|Mean
1310892|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg.~Visit 2 (day14)"|Day 14 +/- 2||||g/m2/h||Standard Deviation|Mean
1310893|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm.~Visit 2 (day14) - intermediate visit"|Day 14 +/- 2||||g/m2/h||Standard Deviation|Mean
1310894|NCT02557698|Primary|Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm.~Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|Male or female gender, aged between 6 months and 85 years|||g/m2/h||Standard Deviation|Mean
1310895|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
1310896|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
1310939|NCT02556307|Secondary|Hemoglobin Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for hemoglobin. Here, n specifies number of participants with data available for specified category."|||gram per liter||Standard Deviation|Mean
1310940|NCT02556307|Secondary|Leukocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for leukocyte value. Here, n specifies number of participants with data available for specified category."|||billion cells per liter||Standard Deviation|Mean
1310897|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.|Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
1310898|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
1310899|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
1310900|NCT02557646|Secondary|Percentage of Participants With SVR According to IL-28B Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1310901|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1310902|NCT02557646|Secondary|Percentage of Participants With SVR According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1310903|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population.|||percentage of participants|||Number
1310904|NCT02557646|Secondary|Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1316377|NCT02393209|Secondary|CL/F: Oral Clearance for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
1310905|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1310906|NCT02557646|Secondary|Percentage of Participants With SVR According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1310907|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1310908|NCT02557646|Secondary|Percentage of Participants With Virologic Response|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.|Week 4, 12, 24 and at EOT (maximum up to 72 weeks)|ITT Population.|||percentage of participants|||Number
1310909|NCT02557646|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin|Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
1310910|NCT02557555|Primary|Survey to Determine Utility and Effect of Educational Materials|In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education. There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions. For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>?|expected average of no later than 48 hours following delivery|The answers from 100 female patients, ages 18-45 admitted to the L&D who answered our survey were analyzed to gage the educational value of our labor analgesia informational pamphlet.|||percentage of patients responding|||Number
1310911|NCT02557399|Secondary|Number of Participants With Severity of AEs|The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.|Up to Week 12|ITT population.|||Participants|||Count of Participants
1310912|NCT02557399|Secondary|Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging|Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).|Week 1, 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1310941|NCT02556307|Secondary|Thrombocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for thrombocyte value. Here, n specifies number of participants with data available for specified category."|||billion cells per liter||Standard Deviation|Mean
1311353|NCT02545868|Secondary|MRI Parameters: Normalized Brain Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
1310913|NCT02557399|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (>=)3 times upper limit of normal (ULN) and total bilirubin >=2xULN (less than [>] 35% direct) was defined.|Up to Week 12|ITT population.|||Participants|||Count of Participants
1310914|NCT02557399|Secondary|Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12|QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.|Baseline(Day 1) and Week 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1310915|NCT02557399|Secondary|Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12|Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).|Week 1, 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1310916|NCT02557399|Secondary|Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12|Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.|Up to Week 12|ITT population.|||Participants|||Number
1310917|NCT02557399|Secondary|Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12|The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant’s compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant’s compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.|Week 1, 2, 4, 8 and 12|ITT population.|||Participants|||Number
1310918|NCT02557399|Secondary|Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12|Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.|Week 1, 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
1310919|NCT02557399|Secondary|Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12|Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.|Week 1, 2, 4, 8 and 12|ITT population.|||Percentage of participants|||Number
1310920|NCT02557399|Secondary|Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12|Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.|Week 1, 2, 4, 8, 12|ITT population.|||Percentage of participants|||Number
1310921|NCT02557399|Secondary|Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||lesion count||Standard Error|Least Squares Mean
1327094|NCT02147899|Secondary|Cure of Bacterial Vaginosis|Number of subjects with therapeutic cure at TOC/EOS (clinical cure + normalization of Nugent score)|Study Days 21-30|||||||
1310922|NCT02557399|Secondary|Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Percent change in lesions||Standard Error|Least Squares Mean
1310923|NCT02557399|Secondary|Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|Baseline (Day 1) and Week 1, 4, 8, 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Percent change in lesions||Standard Error|Least Squares Mean
1310924|NCT02557399|Primary|Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).|Baseline (Day 1) and Week 2|Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one application of study product. Only those participants with data available at the indicated time points were analyzed|||Percent change in lesions||Standard Error|Least Squares Mean
1310925|NCT02557035|Secondary|Percentage of Patients With no Rescue Medication in the Overall Phase||0-120 hours||||Participants|||Count of Participants
1310926|NCT02557035|Secondary|Percentage of Patients With no Rescue Medication in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
1310927|NCT02557035|Secondary|Percentage of Patients With no Rescue Medication in the Acute Phase||0-24 hours||||Participants|||Count of Participants
1310928|NCT02557035|Secondary|Percentage of Patients With no Emetic Episodes in the Overall Phase||0-120 hours||||Participants|||Count of Participants
1310929|NCT02557035|Secondary|Percentage of Patients With no Emetic Episodes in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
1310930|NCT02557035|Secondary|Percentage of Patients With no Emetic Episodes in the Acute Phase||0-24 hours||||Participants|||Count of Participants
1310931|NCT02557035|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase||0-120 hours||||Participants|||Count of Participants
1310932|NCT02557035|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
1310933|NCT02557035|Primary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase||0-24 hours||||Participants|||Count of Participants
1310934|NCT02556632|Primary|Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)|"The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT.~The RDS score ranges from 0-4 with higher scores indicating worse outcome."|Baseline to up to 1 week after completion of radiation therapy|Note: Of the 64 who were randomized to Arm 1, 60 completed 1-week post; of the 65 who were randomized to Arm II, 58 completed 1-week post; of the 62 who were randomized to Arm III, 52 completed 1-week post.|||units on a scale||Standard Deviation|Mean
1310935|NCT02556632|Primary|Incidence of Moist Desquamation (Present vs. Absent)|The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher’s exact test. Each agent’s potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher’s exact test.|Baseline up to completion of radiation therapy|Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study|||Participants|||Count of Participants
1310936|NCT02556632|Primary|Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)|"The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.~The RDS score ranges from 0-4 with higher scores indicating worse outcome."|Baseline up to 1 week post radiation therapy|Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study|||units on a scale||Standard Deviation|Mean
1310937|NCT02556333|Primary|HIV RNA Change From Baseline to Day 10|An HIV RNA decline of >=0.5 log by day 10 will be considered to be an adequate virologic response, to proceed to the second phase of the study.|10 days|One patient with multiple drug resistant HIV infection enrolled into this study.|||log HIV RNA copies/mL|||Number
1310938|NCT02556307|Secondary|Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin||Up to 99.6 Weeks|All treated participants were included.|||weeks||Standard Deviation|Mean
1314918|NCT02434497|Secondary|Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline LDL-C|participants|95% Confidence Interval|Geometric Mean
1310942|NCT02556307|Secondary|HCV RNA Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for HCV RNA. Here, n specifies number of participants with data available for specified category."|||IU/mL||Standard Deviation|Mean
1310943|NCT02556307|Secondary|Percentage of Participants With Undetectable HCV RNA|Undetectable HCV RNA=a single last HCV RNA <20 IU/mL|Weeks 4, 12 and at end of treatment (up to 99.6 weeks)|All treated participants were included in the analysis.|||percentage of participants|||Number
1310944|NCT02556307|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment|SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).|6 months after the last study drug administration (up to 123.6 weeks)|All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).|||percentage of participants|||Number
1310945|NCT02556138|Secondary|Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal|The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.|6 months|Intent to treat analysis|||percentage of weight loss||Standard Deviation|Mean
1310946|NCT02556138|Secondary|Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal|%TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg|6 months|Intent to treat analysis|||percentage of weight loss||Standard Deviation|Mean
1310947|NCT02556138|Primary|Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months|The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.|6 months|Intent to treat analysis|||Participants|||Count of Participants
1310948|NCT02555722|Secondary|Ease of Insertion and Removal - Enfilcon A Lens (Control)|Ease of Insertion and removal was assessed. Scale 0-100 (0=excellent, no problems with lens insertion/removal; 100=unmanageable, lenses impossible to handle)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||units on a scale|Eyes|Standard Deviation|Mean
1310949|NCT02555722|Secondary|Ease of Insertion and Removal - Fanfilcon A Lens (Test)|Ease of Insertion and removal was assessed. Scale 0-100 (0=excellent, no problems with lens insertion/removal; 100=unmanageable, lenses impossible to handle)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||units on a scale|Eyes|Standard Deviation|Mean
1310950|NCT02555722|Secondary|Overall Vision Quality - Enfilcon A Lens (Control)|Overall vision quality and night vision quality is assessed at the specific time points. Scale 0-100 (0=excellent, cannot notice any visual loss; 100=unacceptable, lens cannot be worn)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||units on a scale|Eyes|Standard Deviation|Mean
1310951|NCT02555722|Secondary|Overall Vision Quality - Fanfilcon A Lens (Test)|Overall vision quality and night vision quality is assessed at the specific time points. Scale 0-100 (0=excellent, cannot notice any visual loss; 100=unacceptable, lens cannot be worn)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||units on a scale|Eyes|Standard Deviation|Mean
1310952|NCT02555722|Secondary|Comfort - Enfilcon A Lens (Control)|Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion, comfort during the day, end of the day comfort, overall comfort, and comfort at visit. Scale 0-100 (0=excellent, cannot be felt; 100=causes pain, lens cannot be tolerated)|Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up||||units on a scale|Eyes|Standard Deviation|Mean
1310953|NCT02555722|Secondary|Comfort - Fanfilcon A Lens (Test)|Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion, comfort during the day, end of the day comfort, overall comfort, and comfort at visit. Scale 0-100 (0=excellent, cannot be felt; 100=causes pain, lens cannot be tolerated)|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||units on a scale|Eyes|Standard Deviation|Mean
1310954|NCT02555722|Primary|Average Wearing Time - Enfilcon A Lens (Control)|Average lens wearing time for enfilcon A lens (control) measured in hours.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||hours||Standard Deviation|Mean
1310955|NCT02555722|Primary|Average Wearing Time - Fanfilcon A Lens (Test)|Average lens wearing time for fanfilcon A lens (test) measured in hours.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||hours||Standard Deviation|Mean
1310956|NCT02555722|Primary|Visual Acuity - Enfilcon A Lens (Control)|Visual acuity is assessed for enfilcon A lens (control) using Snellen chart.|Week 1, Week 2, Month 1, Month 2, Month 3||||eyes|Eyes||Number
1310957|NCT02555722|Primary|Visual Acuity - Fanfilcon A Lens (Test)|Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart.|Week 1, Week 2, Month 1, Month 2, Month 3||||eyes|Eyes||Number
1310958|NCT02555722|Primary|Palpebral Conjunctiva - Enfilcon A Lens (Control)|Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310959|NCT02555722|Primary|Palpebral Conjunctiva - Fanfilcon A Lens (Test)|Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310960|NCT02555722|Primary|Bulbar Hyperemia - Enfilcon A Lens (Control)|Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310961|NCT02555722|Primary|Bulbar Hyperemia - Fanfilcon A Lens (Test)|Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310962|NCT02555722|Primary|Limbal Hyperemia - Enfilcon A Lens (Control)|Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1314919|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN||96 weeks||||participants|participants||Number
1310964|NCT02555722|Primary|Corneal Staining - Enfilcon A Lens (Control)|Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310965|NCT02555722|Primary|Corneal Staining - Fanfilcon A Lens (Test)|Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310966|NCT02555722|Primary|Corneal Vascularization - Enfilcon A Lens (Control)|Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310967|NCT02555722|Primary|Corneal Vascularization - Fanfilcon A Lens (Test)|Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310968|NCT02555722|Primary|Corneal Infiltrates - Enfilcon A Lens (Control)|Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310969|NCT02555722|Primary|Corneal Infiltrates - Fanfilcon A Lens (Test)|Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310970|NCT02555722|Primary|Stromal Edema - Enfilcon A Lens (Control)|Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310971|NCT02555722|Primary|Stromal Edema - Fanfilcon A Lens (Test)|Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310972|NCT02555722|Primary|Epithelial Edema - Enfilcon A Lens (Control)|Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310973|NCT02555722|Primary|Epithelial Edema - Fanfilcon A Lens (Test)|Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||percentage of eyes|Eyes||Number
1310974|NCT02555631|Secondary|Number of Participants That Participated in Each Session|this is measured by direct observation at selected sessions; report by the lifestyle coach; and discussion during focus groups at the end of the 16 weeks|16 weeks||||Participants|||Number
1310975|NCT02555631|Secondary|Number of Sessions Attended|with a measured goal of at least attendance observed and recorded at 9/16 sessions on average|16 weeks||||Sessions Attended||Standard Deviation|Mean
1310976|NCT02555631|Secondary|Number of Men Enrolled During 8 Weeks of Recruitment|measured by numbers of men and the timeframe in which the recruitment takes place;|8 weeks||||Participants|||Count of Participants
1310977|NCT02555631|Primary|Change in Weight in Pounds|the goal is to lose 5-7% of baseline body weight for pre-diabetic men|Baseline, 16 weeks||||percentage of body weight lost||Full Range|Mean
1310978|NCT02555618|Secondary|Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs|The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.|||percentage of participants|||Number
1310979|NCT02555618|Secondary|Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|22 days|Safety Analysis Set included all participants who received vaccination with study vaccine.|||percentage of participants|||Number
1310980|NCT02555618|Secondary|Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)|Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.|||percentage of participants|||Number
1310981|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
1310982|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310983|NCT02555618|Secondary|GMT of SRH Antibody Titer (Vero-Derived Antigen)|GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||titer||95% Confidence Interval|Geometric Mean
1314920|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN||96 weeks||||participants|participants||Number
1310984|NCT02555618|Secondary|Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310985|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
1310986|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310987|NCT02555618|Secondary|GMT of HI Antibody Titer (Vero-Derived Antigen)|GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||titer||95% Confidence Interval|Geometric Mean
1310988|NCT02555618|Secondary|Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of <10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310989|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
1310990|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310991|NCT02555618|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||mm^2||95% Confidence Interval|Geometric Mean
1310992|NCT02555618|Secondary|Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310993|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
1310994|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310995|NCT02555618|Primary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||titer||95% Confidence Interval|Geometric Mean
1351307|NCT01780922|Primary|Reduced Glutathione (GSH) Concentrations in Red Blood Cells||0, 2, 4, 8, 24 h||||mmol/L||Standard Error|Mean
1310996|NCT02555618|Primary|Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|"Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.~Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10."|Baseline and Day 22|Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
1310997|NCT02555228|Secondary|Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution||Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours||||number of events|||Number
1310998|NCT02555228|Secondary|Volume of Additional Manual Flushes Required During Endoscopy in Mls|The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.||||mls||Standard Deviation|Mean
1310999|NCT02555228|Secondary|Mucosal Visibility Score Per Area as Determined by Mc Nally Score:|"Area E: esophagus~Area D: duodenum~Area A: antrum and angularis~Area B: body and fundus~Mc Nally score per area:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.||||units on a scale||Standard Deviation|Mean
1311000|NCT02555228|Primary|Total Cumulative Mucosal Visibility Score|"Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured~Total areas covered:~(E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.||||units||Standard Deviation|Mean
1311001|NCT02554981|Secondary|Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye|Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. A positive number change from Baseline indicates a worsening and a negative number change from Baseline indicates an improvement.|Baseline, Month 6|"Participant from the ITT population, all enrolled participants who received at least one dose of study drug, with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311002|NCT02554981|Secondary|Change From Baseline in Reading on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311003|NCT02554981|Secondary|Change From Baseline in Poor Vision on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311004|NCT02554981|Secondary|Change From Baseline in Blurred Vision on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311005|NCT02554981|Secondary|Change From Baseline in Watching Television (TV) on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311006|NCT02554981|Secondary|Change From Baseline in Working With a Computer or Bank Machine on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Working with a Computer or Bank Machine question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311038|NCT02554435|Secondary|Psychological Feelings|Measured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.|Psychological feelings at the end of the 12 week intervention||||units on a scale||Standard Deviation|Mean
1311007|NCT02554981|Secondary|Change From Baseline in Driving at Night on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Driving at Night question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311008|NCT02554981|Secondary|Change From Baseline in OSDI© Total Score|The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311009|NCT02554981|Secondary|Change From Baseline in Interblink Interval (IBI) in the Worst Eye|A device was used to assess IBI. The IBI measures the time in seconds between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.|Baseline, Month 6|"ITT population included all enrolled participants who received at least 1 dose of study drug. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
1311010|NCT02554981|Secondary|Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye|A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||percent of area||Standard Deviation|Mean
1311011|NCT02554981|Secondary|Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye|TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
1311012|NCT02554981|Primary|Change From Baseline in Reading Rate|Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||correct words/minute||Standard Deviation|Mean
1311013|NCT02554981|Primary|Change From Baseline in Time to Read Passage|The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
1311014|NCT02554981|Primary|Change From Baseline in Words Read Incorrectly|The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||incorrect words||Standard Deviation|Mean
1311015|NCT02554981|Primary|Change From Baseline in Font Size|The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||points||Standard Deviation|Mean
1311016|NCT02554981|Primary|Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye|Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311017|NCT02554981|Primary|Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye|Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311144|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311018|NCT02554981|Primary|Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye|Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311019|NCT02554981|Primary|Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye|Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311020|NCT02554981|Primary|Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye|Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311021|NCT02554981|Primary|Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye|Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311022|NCT02554877|Secondary|Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.|The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||kg||Standard Deviation|Mean
1311023|NCT02554877|Secondary|Percent Changes From Baseline for Non‑High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12|Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1311024|NCT02554877|Secondary|Percent Changes From Baseline for High Density Lipoprotein‑Cholesterol (HDL‑C) at Weeks 2, 4, 8 and 12|High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1311025|NCT02554877|Secondary|Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12|Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1311026|NCT02554877|Secondary|Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12|Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days. Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead. If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM. An outlier was defined as any data point falling outside of 3.5 x standard deviations the median.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Full Range|Median
1311056|NCT02554279|Secondary|Follicular Development as Assessed by TVUS|Defined as percentage of participants with follicles having a diameter of ≤9 mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm.|On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
1311027|NCT02554877|Secondary|Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12|Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1311028|NCT02554877|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).|An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE.|Baseline up to Day 119|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1311029|NCT02554877|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to Day 98|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1311030|NCT02554877|Secondary|Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria|ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 milliseconds (msec); >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 msec; >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.|Baseline up to Day 98|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1311031|NCT02554877|Secondary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to 98 days|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1311032|NCT02554877|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.|||% (percentage of participants)||95% Confidence Interval|Number
1311033|NCT02554877|Secondary|Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12|Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2,4,8 and 12|All participants randomized and who had received at least 1 dose of randomized treatment. n represented the available number of participants for analysis at post-baseline days.|||mg/dL||Standard Deviation|Mean
1311034|NCT02554877|Secondary|Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.n represented the available number of participants for analysis at post-baseline days.|||percentage of HbA1c||Standard Deviation|Mean
1311035|NCT02554877|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.|Baseline, Week 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.|||percentage of HbA1c||Standard Deviation|Mean
1311036|NCT02554435|Secondary|Change From Baseline in Self-regulation|Measured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.|Change in self-regulation from baseline and 12-weeks||||units on a scale||Standard Deviation|Mean
1311037|NCT02554435|Secondary|Resting Pulse||Resting pulse at the end of the 12 week intervention||||bpm||Standard Deviation|Mean
1311057|NCT02554279|Secondary|Follicular Development as Assessed by TVUS|Defined as average follicle size and average size of 3 largest follicles.|On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||mm||Standard Deviation|Mean
1311039|NCT02554435|Secondary|Physical Function Measured by the Short Physical Performance Battery|"Physical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled tandem balance."|Physical function at the end of the 12 week intervention||||seconds||Standard Deviation|Mean
1311040|NCT02554435|Secondary|Quality of Life Measured by the SF-36 Questionnaire|Sub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale.|Quality of life at the end of the 12 week intervention||||units on a scale||Standard Deviation|Mean
1311041|NCT02554435|Secondary|Exercise Motivation|"Measured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of intrinsic and identified are better. Alternatively, low scores of introjected, extrinsic, and amotivation are better."|Exercise motivation at the end of the 12 week intervention||||units on a scale||Standard Deviation|Mean
1311042|NCT02554435|Secondary|Blood Pressure||Blood pressure at the end of the 12 week intervention||||mmHg||Standard Deviation|Mean
1311043|NCT02554435|Secondary|Waist-to-Hip Ratio|Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).|Waist-to-hip ratio at the end of the 12 week intervention||||ratio||Standard Deviation|Mean
1311044|NCT02554435|Secondary|Body Mass Index (BMI)||BMI at the end of the 12 week intervention||||kg/m^2||Standard Deviation|Mean
1311045|NCT02554435|Secondary|Weight||Weight at the end of the 12 week intervention||||kg||Standard Deviation|Mean
1311046|NCT02554435|Primary|Steps Per Day|Measured by a SenseWear Armband. Average steps per day over a 7 day period|Steps per day at the end of the 12 week intervention||||steps||Standard Deviation|Mean
1311047|NCT02554435|Primary|6-minute Walk Test|distance walked in 6 minutes|Fitness at the end of the 12 week intervention||||feet||Standard Deviation|Mean
1311048|NCT02554435|Primary|Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator|Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to >30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to >30% risk of a cardiovascular event within the next 10 years.|Cardiovascular risk at the end of the 12 week intervention||||Risk score||Standard Deviation|Mean
1311049|NCT02554435|Primary|Physical Activity Minutes Measured by a SenseWear Armband|Minutes of moderate-vigorous physical activity over a 7 day period|Physical activity minutes at the end of the 12 week intervention||||minutes per day||Standard Deviation|Mean
1311050|NCT02554279|Secondary|Quality of Blastocysts|Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell).|5 days after oocyte retrieval|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of embryos|Embryos reaching blastocyst stage||Number
1311051|NCT02554279|Secondary|Quality of Embryos|Assessed by cleavage stage.|3 days after oocyte retrieval|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||blastomeres|Total number of embryos|Standard Deviation|Mean
1311052|NCT02554279|Secondary|Quality of Embryos|Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.|3 days after oocyte retrieval|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of embryos|Total number of embryos||Number
1311053|NCT02554279|Secondary|Fertilization Rate|Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.|On day 1 post-insemination|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of each participant||Standard Deviation|Mean
1311054|NCT02554279|Secondary|Number of Metaphase II Oocytes||At oocyte retrieval visit (approximately 36 hours after hCG administration)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved.|||metaphase II oocytes||Standard Deviation|Mean
1311055|NCT02554279|Secondary|Number of Oocytes Retrieved||At oocyte retrieval visit (approximately 36 hours after hCG administration)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved.|||oocytes||Standard Deviation|Mean
1311145|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311058|NCT02554279|Secondary|Early Pregnancy Loss|Defined as participants with 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks of gestation in the fresh cycle. Percentage of participants with early pregnancy loss is presented.|At 10-11 weeks of gestation in the fresh cycle|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
1311059|NCT02554279|Secondary|Clinical Pregnancy Rate|Defined as percentage of participants with transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 6-7 weeks of gestation.|4-5 weeks after blastocyst transfer in the fresh cycle|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
1311060|NCT02554279|Secondary|Positive β-human Chorionic Gonadotropin (hCG) Rate|Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.|First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positive|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
1311061|NCT02554279|Primary|Ongoing Pregnancy Rate|Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation.|8-9 weeks after blastocyst transfer in the fresh cycle|The modified intent-to-treat (mITT) analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
1311062|NCT02553772|Secondary|Change From Baseline in the Schirmer Test|The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Day 90|"ITT population included all randomized participants. n is the number of participants in the category with data available at the given time-point."|||mm||Standard Deviation|Mean
1311063|NCT02553772|Secondary|Change From Baseline in Conjunctival Staining Score|Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Day 90|"ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311064|NCT02553772|Secondary|Change From Baseline in Corneal Staining Score|Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Day 90|"ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1311065|NCT02553772|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.|Baseline, Day 90|"ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
1311066|NCT02553772|Primary|Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score|The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.|Baseline, Day 90|Intent-to-treat population included all randomized participants.|||score on a scale||Standard Deviation|Mean
1311067|NCT02553629|Secondary|Mean Arterial Blood Pressure|"Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit.~The data will be averaged per subject and the mean of the mean values are reported."|2 hours postoperative||||millimeters of mercury||Standard Deviation|Mean
1311068|NCT02553629|Secondary|Respiration|"Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged.~The data were averaged per subject and the mean of the mean data are reported."|2 hours postoperative||||breaths per minute||Standard Deviation|Mean
1311069|NCT02553629|Secondary|Pain|pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.|postoperative, for up to 2 hours||||units on a scale||Standard Deviation|Mean
1311070|NCT02553629|Secondary|Extubation|The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).|intraoperative||||minutes||Inter-Quartile Range|Mean
1311071|NCT02553629|Primary|Surgical Rating|"During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated.~The rating scale will be averaged for each subject and the mean values will be reported."|intraoperative||||units on a scale||Standard Deviation|Mean
1311072|NCT02553538|Primary|Percentage of Cancer Screening Tests Completed - As Treated|The primary outcome was the average cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in as treated analyses - excluding patients who either left the network or died during follow-up. The cancer screening test completion rate for each subject was calculated daily, then averaged across the 8-month study period. On any given day, the screening test completion rate was calculated as the number of tests completed divided by the number of eligible tests.|8 Months||||percentage of completed screening visits||95% Confidence Interval|Mean
1311073|NCT02553538|Secondary|Percentage of Patients Completing Any Cancer Screening Test (As Treated)|The percentage of patients completing any cancer screening during follow-up among those who were eligible and overdue for at least one cancer screening at baseline in intention to treat analyses, as the percentage of patients completing each type of cancer screening among those who were eligible and overdue at baseline, removing patients who left our primary care network or who died during follow-up from both intervention and control arms, and also removed patients the navigators were not able to contact from the intervention arm.|8 Months||||percentage of patients|||Number
1311074|NCT02553538|Secondary|Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)|The percentage of patients completing any cancer screening during follow-up among those who were eligible and overdue for at least one cancer screening at baseline in intention to treat analyses, as the percentage of patients completing each type of cancer screening among those who were eligible and overdue at baseline in intention to treat analyses.|8 Months||||percentage of patients|||Number
1311075|NCT02553538|Primary|Percentage of Cancer Screening Tests Completed - Intention to Treat|The primary outcome was the overall cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in intention to treat analyses. For example, a patient who was eligible for a total of 3 screening tests at a given time could have a completion rate of 0% (none of the 3 tests completed) 33%, 67%, or 100% (all 3 tests completed). By assessing each patient’s completion rate over the 8-month follow-up period, the average completion rate over time was estimated from the area under the curve. We also calculated the completion rate for each individual cancer as the percentage of time screening was up to date among eligible patients during follow-up.|8 months||||percentage of screening visits completed||95% Confidence Interval|Mean
1311076|NCT02553512|Secondary|Blood Pressure Management After Use of Digital Health Offering|Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist)|4 weeks||||Participants|||Count of Participants
1311077|NCT02553512|Secondary|Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering|Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline|2 weeks||||mm Hg||95% Confidence Interval|Mean
1311078|NCT02553512|Secondary|Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment|Percentage of participants|2 weeks||||percentage of participants|||Number
1311079|NCT02553512|Primary|Pattern of Medication-taking (% Scheduling Adherence)|Percent scheduling adherence is determined by the number of ingestion sensors detected within a ± 2-hour time window around the prescribed dosing period, divided by the number of ingestion sensors detected by the wearable sensor during that dosing period, over the 2-week time frame.|2 weeks||||percentage of scheduling adherence||Full Range|Median
1311080|NCT02553512|Primary|Frequency of Medication-taking (% Taking Adherence)|Percent timing adherence is determined by the number of ingestion sensors detected by the wearable monitor, divided by the total number of ingestion sensors prescribed, for the 2 week-time frame.|2 weeks||||percentage of taking adherence||Full Range|Median
1311081|NCT02553421|Primary|Notification Rate of ivWatch Device|The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|The number of participated in the Alarming group that did not have an infiltration diagnosed by a clinician.|||Notifications per day||95% Confidence Interval|Number
1311082|NCT02553421|Primary|Infiltration Sensitivity|The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician’s diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician’s diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week||||percentage of infiltrations detected||95% Confidence Interval|Number
1311083|NCT02553421|Primary|Time Infiltration Detected by Nurse|The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician’s diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week||||hours||95% Confidence Interval|Mean
1311084|NCT02552810|Secondary|Percentage of Patients With Bleeding on Probing|Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.|At 5 years.||||percentage of participants|||Number
1311085|NCT02552810|Secondary|Percentage of Patients With Plaque Index|Modified Plaque Index (mPI) was evaluated as the amount of plaque at the cervical part of the implant-supported crown, scored by running a probe along the implant-supported crown surface. Measured as Yes or Not.|At 5 years.||||percentage of participants|||Number
1311108|NCT02550288|Primary|Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 5 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311086|NCT02552810|Secondary|Esthetic Parameters Measured as the Changes in Mesial and Distal Papilla Height (PH) and Buccal Peri-implant Mucosa Changes at the Zenith (REC), Expressed in mm.|"A customized millimeter tubular support (stent) was placed temporarily around each dental implant. For each site, mesial and distal soft tissue dimensions (papilla height, PH), and buccal peri-implant mucosa dimension at the zenith (REC) were measured, and reported in millimeters. Two measurements were recorded. The first at definitive crown delivery (baseline), and the second at the 5 years follow-up examination. Changes in PH and REC were reported in millimeters as the difference between values recorded at the 5-year follow-up and the baseline.~The full procedure was published in:~Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clinical Oral Implants Research [Internet]. 2009 Apr;20(4):414–20."|At 5 years.||||mm||Standard Deviation|Mean
1311087|NCT02552810|Secondary|Peri-implant Marginal Bone Level Changes (Express in mm).|At the time of loading with the provisional crown (T0), periapical standardized digital or analogical radiographs were taken in order to control the perfect adaptation of the abutment on the implant and control peri-implant bone level. The customized film holder was made using an hard silicone on the bite of film holders (Rinn XCP; Dentsply Rinn, Elgin, IL, USA) and the parallel technique was used. Radiographs were also taken at 12 (T1), 24 (T2), 48 (T4), and 60 months (T5) after the final restoration delivery, to evaluate marginal bone level changes.|At 5 years.||||mm||Standard Deviation|Mean
1311088|NCT02552810|Secondary|Any Biological or Technical Complications.|Complications: any biological (pain, swelling, suppuration, etc) and/or mechanical complications (fracture of the framework and/or the veneering material, screw loosening, etc) were considered.|During all the follow-up (5 years)||||participants|||Number
1311089|NCT02552810|Primary|Success Rate of the Implants and Prostheses (Participants).|"An implant was considered a failure if it presented any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, and/or any signs of radiolucency, progressive marginal bone loss or infection, and any mechanical complications (e.g. implant fracture) rendering the implant unusable, though still mechanically stable in the bone. This was evaluated on an intraoral radiograph taken with a paralleling technique strictly perpendicular to the implant-bone interface. The implant stability was assessed at initial loading and following 3 years of application, with the prostheses removed.~A prosthesis was considered a failure if it needed to be replaced by an alternative prosthesis."|During all the follow-up (5 years)||||percentage of participants|||Number
1311090|NCT02552303|Secondary|Number of Subjects Who Dropped Out|"Drop-out rates will be calculated by the number of protocol weeks the subject completed before withdrawing from the study. Drop out rates for subjects taking active v. placebo study medication were compared.~Withdrawal indicates subjects who were either lost-to-follow-up (LTFU), chose to withdraw (self-withdrawn), were withdrawn by the study's PI (withdrawn by the investigator)."|up to 8 weeks of active study||||Participants|||Count of Participants
1311091|NCT02552303|Primary|The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).|"This outcome measure is based on changes in sleep continuity, as assessed by the Insomnia Severity Index (ISI), which is administered once at baseline and once at follow-up. The ISI (Morin, 1993) was used to assess perceived sleep difficulties or current insomnia symptom severity (i.e., past two weeks). The ISI is a 7-item, self-report instrument with good reliability and validity, and positively correlated with clinician-rated insomnia diagnoses (Bastien, Vallières, & Morin, 2001). Total scores on the full 7-item scale range from 0 – 28 with higher values representing greater sleep continuity disturbance or insomnia severity.~The four different treatment groups will be compared for differences."|ISI is measured once at baseline and once at follow-up (8-10 weeks apart)||||units on a scale (ISI)||Standard Deviation|Mean
1311092|NCT02551887|Secondary|Second Dose HPV Vaccine Uptake|The rate of second dose of HPV vaccine uptake, is recorded as the number of patients who receive the second dose of HPV vaccine.|Nine Months|Number in the control condition who were eligible for 2 doses of vaccine.|||Participants|||Number
1311093|NCT02551887|Primary|First Dose HPV Vaccine Uptake|The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.|Nine Months|Number of patients that received the first dose of HPV vaccine.|||Participants|||Number
1311094|NCT02551822|Secondary|Patient Global Impression of Improvement (PGI-I) Questionnaire Scale Results|The Patient Global Impression of Improvement (PGI-I) scale is a global index that may be used to rate the response of a condition to a therapy. It is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a 7 point scale, 1 indicating the participant's condition is ”Very much better” (best possible outcome), and 7 being “Very much worse” (worst possible outcome). The answers to the 7 questions were then averaged to a score.|Three months after change in program from cycling to continuous or vice versa.|2 Participants in group A and 2 participants in group B withdrew from the study prior to completion.|||units on a scale||Standard Deviation|Mean
1311095|NCT02551822|Secondary|Voiding Diary: Urge Incontinence Episodes|Bladder Diaries (BD) are a useful clinical tool and one of the most common outcome measure used in studies of urinary incontinence and other forms of lower urinary tract dysfunction. The patient is asked to prospectively record the frequency, number and volume of voids and incontinence episodes. The National Institutes of Health (NIH) recommends diary duration of at least three days for research studies.|Three months after change in program from cycling to continuous or vice versa.|2 Participants from group A and two participants from group B withdrew from the study prior to completion.|||Number of leaks per day on 3 day diary||Standard Deviation|Mean
1311109|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessment of AST that was 5x ULN or greater were recorded. AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311110|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311096|NCT02551822|Primary|Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result|"The Overactive Bladder Questionnaire (OAB-q) assesses symptom bother & health-related quality of life (HRQL) for overactive bladder. The short form OAB-q SF, provides a quick assessment of symptom bother, consisting of a 6-item symptom bother scale. The questionnaire is on a 6 point scale, 1 indicates symptom is not bothersome (best outcome), 6 indicates symptom bothers the participant a very great deal (worst possible outcome). The majority of the participants were missing the HRQL portion of the questionnaire, so this portion of the questionnaire was not included in the analysis. These are the raw scores ranges for each question prior to being transformed. The possible scores for complete surveys range from 13 (if the participant marked not bothersome for all 6) to 78 (if the participant marked a very great deal for all 6 questions) once transformed. The reported numbers are the transformed scores [(actual raw score-lowest possible score)/possible raw score range] X 100."|Three months after change in program from cycling to continuous or vice versa.|Two participants in group A and two participants in group B withdrew from the study prior to completion.|||units on a scale||Standard Deviation|Mean
1311097|NCT02551653|Primary|Standardized Uptake Values (SUV) of Radiolabeled GSK2256098 Measured by PET Scan|The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the mean standardized uptake value (SUV) averaged over the 60 minute period between 30 and 90 minutes. The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.|Day 1|Safety Population|||Grams per milliliter (g/mL)||Standard Deviation|Mean
1311098|NCT02551653|Primary|Volume of Distribution of Radiolabeled GSK2256098 Measured by PET Scan|The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the volume of distribution (VT). The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.|Day 1|Safety Population|||Milliliter per cubic centimeter(mL/cm^3)||Standard Deviation|Mean
1311099|NCT02551224|Secondary|Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.|To measure in COPD patients naïve to DPIs, the comfort of the mouth pieces when performing a tight seal with the lips using the Breezhaler® and Ellipta® devices.The mean (SD) score on a scale of 1 – 5 (1 = not at all easy, 2= not very easy, 3=somewhat easy, 4=very easy, 5 = extremely easy)|6 hours|full analysis set|||units on a scale||Standard Deviation|Mean
1311100|NCT02551224|Primary|Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices|"This study will measure patient’s perceptions of dose delivery, using a preference questionnaire on use of the Breezhaler® & Ellipta® devices, in COPD patients naïve to DPI devices.The mean (SD) score on a scale of 1– 5 (1 = not at all confident/not at all; 5 = extremely confident/a very great deal) 1a. How confident were you that you received the full dose of medication from your inhaler?~1=Not At All Confident, 2=Not Very Confident, 3=Somewhat Confident, 4=Confident, 5=Extremely Confident~1b. How certain were you that there was no drug remaining in the device?~1=Not At All Certain,2=Not Very Certain, 3=Somewhat Certain,4=Certain, 5=Extremely Certain~1c. To what extent did the device help you to know that you have received all the medication?~1=Not At All, 2=A Little, 3=Somewhat, 4=Very Much, 5=A Very Great Deal"|6 hours|Full analysis set|||units on a scale||Standard Deviation|Mean
1311101|NCT02550288|Primary|Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms|Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311102|NCT02550288|Primary|Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms|Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311103|NCT02550288|Primary|Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN|Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311104|NCT02550288|Primary|Percentage of Participants With Potential Hy's Law Condition|Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311105|NCT02550288|Primary|Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311106|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 10x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311107|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1314921|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN||96 weeks||||participants|participants||Number
1311111|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311112|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311113|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311114|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Hepatitis-related AEs|Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311115|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs|Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311116|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Gallbladder-related AEs|Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311117|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)|Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
1311118|NCT02550288|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.|Baseline and Week 12|All participants who received at least 1 dose of study treatment, and had a baseline observation or at least 1 post-baseline observation. One participant who received misallocated study medication during placebo run-in period was excluded from the main population for the analysis of efficacy data.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1311119|NCT02550197|Primary|Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.|Day 0 up Day 7 post-vaccination|Solicited injection-site and systemic reactions were analyzed in the Safety Analysis Set.|||Percentage of Participants|||Number
1311120|NCT02550197|Primary|Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature >38.0˚C for at least 1 day), Malaise, and Shivering (rigors).|Day 0 up Day 3 post-vaccination|Solicited reactions were analyzed in the Safety Analysis Set.|||Percentage of Participants|||Number
1311121|NCT02550197|Primary|Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titer ratios of influenza antibodies were assessed in the Immunogenicity Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1311122|NCT02550197|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.|Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.|||Percentage of Participants|||Number
1314922|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN||96 weeks||||participants|participants||Number
1311123|NCT02550197|Primary|Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.|||Percentage of Participants|||Number
1311124|NCT02550197|Primary|Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Immunogenicity Analysis Set.|||Percentage of Participants|||Number
1311125|NCT02550197|Primary|Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers of influenza antibodies were assessed in the Immunogenicity Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1311126|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311127|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311128|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311129|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311130|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311131|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311132|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311133|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311134|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311135|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311136|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311137|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
1311138|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311139|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311140|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311141|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311142|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311143|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311146|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311147|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311148|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311149|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311150|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311151|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311152|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311153|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
1311154|NCT02549755|Primary|To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate|The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.|At three months|||||||
1311155|NCT02549573|Other Pre-specified|Hospital Anxiety and Depression Scale - Change From Baseline in Depression|The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in depression.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311156|NCT02549573|Other Pre-specified|Change From Baseline in Patient Global Impression of Severity (PGI-S)|Self reported (caregiver, if applicable) impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. One subject in APO+ group did not have an end of study assessment for PGI-S.|||units on a scale||Standard Deviation|Mean
1311157|NCT02549573|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S)|Investigator's impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311158|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part I B|MDS-UPDRS Part I B is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 28 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (subject rated).|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311159|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part IV|MDS-UPDRS Part IV is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents fewer motor complications.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311160|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part II|MDS-UPDRS Part II is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 52 (worst score possible). A negative change from baseline represents an improvement in motor experience of daily living.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311161|NCT02549573|Other Pre-specified|Change From Baseline in Number of Falls as Reported by the Subject in the Past 1 Week|Subject reported number of falls. A negative change from baseline represents a decrease in the frequency of falls.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||number of falls reported||Standard Deviation|Mean
1314923|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN||96 weeks||||participants|participants||Number
1311162|NCT02549573|Other Pre-specified|Number of Participants in Each Category of Patient Global Impression of Change (PGI-C)|Self reported (caregiver, if applicable) impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from much improved to very much worse.|After week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||Participants|||Count of Participants
1311163|NCT02549573|Other Pre-specified|Hospital Anxiety and Depression Scale - Change From Baseline in Anxiety|The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in anxiety.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311164|NCT02549573|Other Pre-specified|Change From Baseline in Parkinson’s Fatigue Scale (PFS-16)|PFS-16 is a subject reported scale evaluating physical effects of fatigue and the impact on daily function, with a minimum score of 16 and a maximum score of 80. A negative change from baseline represents an improvement in physical effects of fatigue and the impact on daily function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311165|NCT02549573|Other Pre-specified|Change From Baseline in Parkinson’s Disease Questionnaire (PDQ-39)|PDQ-39 is a scale measuring subject reported aspects of functioning and well-being. Each of the 39 items is rated using a 5-points Likert scale, with 0 for never having difficulties/problems and 4 for all always having difficulties/problems. The total score is the sum of the 39 items, with a minimum score of 0 and a maximum score of 156. A negative change from baseline represents an improvement in functioning and well-being.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311166|NCT02549573|Secondary|Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C)|Investigator's impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from very much improved to very much worse.|After week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||Participants|||Count of Participants
1311167|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part I A|MDS-UPDRS Part I A is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (investigator rated).|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311168|NCT02549573|Secondary|Change From Baseline in Montreal Cognitive Assessment (MoCA)|The MoCA is a validated, 30-point test (sum of the 6 domains) designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). Total MoCA scores higher than 26 indicate normal cognitive function. A positive change from baseline represents an improvement in cognitive function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311169|NCT02549573|Secondary|Change From Baseline in 6-Minute Walk Test (6MWT)|Objective performance based measure of functional exercise capacity that measures the distance a subject can cover on a 30 meter flat walking area over 6 minutes. A positive change from baseline represents an improvement in the distance walked (ft) in 6 minutes.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||feet||Standard Deviation|Mean
1311170|NCT02549573|Secondary|Change From Baseline in Timed-Up-and-Go (TUG) Test|Test captures the amount of time for a subject to get up from an arm chair, walk 3 meters, turn around, walk back to chair, and sit. A negative change from baseline represents an improvement of physical function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||seconds||Standard Deviation|Mean
1311171|NCT02549573|Secondary|Change From Baseline in Modified Physical Performance Test (M-PPT)|Investigator scale assessing 9 domains of physical functioning where total scores range from 0 to 28 with higher scores indicating better physical performance. A positive change from baseline represents an improvement in physical performance.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311172|NCT02549573|Secondary|Change From Baseline in Movement Disorder Societies Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)|MDS-UPDRS Part III is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 72 (worst score possible). A negative change from baseline represents an improvement in motor function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
1311173|NCT02549573|Primary|Change From Baseline in Activities-specific Balance Confidence (ABC) Scale|Scale from 0 to 100% where an increase in percent represents an improvement in balance confidence.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||percent change||Standard Deviation|Mean
1311184|NCT02549014|Secondary|Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064|Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||µmol/L||Standard Deviation|Geometric Mean
1311174|NCT02549027|Secondary|Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)|||milliseconds||95% Confidence Interval|Mean
1311175|NCT02549027|Secondary|Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4|||milliseconds||95% Confidence Interval|Mean
1311176|NCT02549027|Secondary|WASO Following Single Doses of MK-6096 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)|||minutes||95% Confidence Interval|Geometric Mean
1311177|NCT02549027|Secondary|Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4|||minutes||95% Confidence Interval|Geometric Mean
1311178|NCT02549027|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.|||participants|||Number
1311179|NCT02549027|Primary|Number of Participants With Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.|||participants|||Number
1311180|NCT02549027|Primary|LPS Following Single Doses of MK-6096 and Placebo|LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)|||minutes||95% Confidence Interval|Geometric Mean
1311181|NCT02549027|Primary|Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo|LPS is measured during overnight sleep laboratory (polysomnography [PSG]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4|||minutes||95% Confidence Interval|Geometric Mean
1311182|NCT02549014|Secondary|Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064|t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||hr||Standard Deviation|Geometric Mean
1311183|NCT02549014|Secondary|Time to Cmax (Tmax) Following Single Doses of MK-1064|Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||hr||Full Range|Median
1311281|NCT02547623|Secondary|Visual Acuity in Study Eye|Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||LogMar||Standard Deviation|Mean
1311185|NCT02549014|Secondary|Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064|AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||µmol*hr/L||Standard Deviation|Geometric Mean
1311186|NCT02549014|Primary|Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064|AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.|Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose|All participants who received ≥1 dose of MK-1064.|||µmol*hr/L||Standard Deviation|Geometric Mean
1311187|NCT02549014|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.|||Participants|||Number
1311188|NCT02549014|Primary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.|||Participants|||Number
1311189|NCT02548845|Secondary|Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)|Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels – date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels – date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels [censored patients]).|Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)|The overall number of patients analysed represents the number of participants for which the data (time in hours) was available. As a retrospective chart review, there were some missing data in this outcome measure (time of improvement in this case)|||hours||95% Confidence Interval|Median
1311190|NCT02548845|Secondary|Length of Hospitalisation (Measured From the Start of the Hyponatraemia Episode to Discharge) for Patients Who Were and Were Not Treated in Adherence With the Algorithm||Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)||||Days||95% Confidence Interval|Median
1311191|NCT02548845|Secondary|Time to Initiation or Re-initiation of Chemotherapy (Since the Start of the Hyponatraemia Episode) in Patients Candidate for Chemotherapy Who Were and Were Not Treated in Adherence With the SEOM Algorithm.||Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)|In this analysis, only the 22 patients who were candidate for chemotherapy during the study period were included, this explains the difference with the total number of participants.|||Hours||95% Confidence Interval|Median
1311192|NCT02548845|Secondary|Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)|Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels – date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels – date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels [censored patients]).|Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)|The overall number of patients analysed represents the number of participants for which the data (time in days) was available. As a retrospective chart review, there were some missing data in this outcome measure (date of improvement in this case)|||Days||95% Confidence Interval|Median
1311193|NCT02548845|Primary|Number of Patients Managed According to the SEOM Algorithm (as a Result Adherence to the Algorithm Will be the % of These Patients Among the Total Number of Patients)|Adherence to the algorithm will be evaluated using a pre-defined decision tree that will be provided in the electronic case report form (eCRF) and will be completed by the investigator|Participants will be followed for the duration of hospital stay, an expected average of 4 days (follow-up will stop after a maximum of 6 weeks)||||Participants|||Count of Participants
1311194|NCT02548455|Primary|Number of Patients Free From LV Lead-related Complications Through 3 Months|A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.|3 months|The first 94 subjects who underwent an attempted implant of the Quartet 1457Q lead and either completed a 3-month follow-up visit, withdrew from the study or died prior to the 3-month follow-up visit.|||Participants|||Count of Participants
1311282|NCT02547623|Secondary|Intraocular Pressure Measurement|Intraocular Pressure was measured by Goldmann applanation tonometry.|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||mmHG||Standard Deviation|Mean
1311195|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||ppm||Standard Deviation|Mean
1311196|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||ppm||Standard Error|Least Squares Mean
1311197|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||ppm||Standard Error|Mean
1311198|NCT02548156|Primary|Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||parts per million(ppm)||Standard Error|Least Squares Mean
1311199|NCT02548078|Secondary|Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum|A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on subjects aged 1-5 years, 6-12 years and 13-17 years.|At Day 0, Day 30, Month 6 and Month 6 + 30 Days|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Percentage of participants|||Number
1311200|NCT02548078|Secondary|Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall|A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on all subjects, in both groups.|At Day 0, Day 30, Month 6 and Month 6 + 30 Days.|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Percentage of participants|||Number
1311201|NCT02548078|Secondary|Anti-GP EBOV Antibody Titers, by Age Stratum|Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.|At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1311202|NCT02548078|Secondary|Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall|Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in all subjects, in both groups.|At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12.|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1311203|NCT02548078|Primary|Number of Subjects With Serious Adverse Events, by Age Stratum|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.|During the entire study period: From Screening to Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311204|NCT02548078|Primary|Number of Subjects With Serious Adverse Events, Overall|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in all subjects, in both groups.|During the entire study period: From Screening to Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311205|NCT02548078|Primary|Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum|AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.|During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311415|NCT02544074|Secondary|eSAGE Score Compared to the Boston Naming Test Score|The investigators will compare the eSAGE scores to the Boston Naming Test scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311206|NCT02548078|Primary|Number of Subjects With Adverse Events of Specific Interest (AESI), Overall|AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.|During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311207|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
1311208|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 12.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
1311209|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.|||Percentage of participants|||Number
1311210|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.|||Percentage of participants|||Number
1311211|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.|||Percentage of participants|||Number
1311212|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.|||Percentage of participants|||Number
1311213|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
1311214|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
1311215|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
1311216|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 30.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
1311217|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of particcipants|||Number
1311218|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of participants|||Number
1311283|NCT02547623|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.|Baseline to postoperative day 90/ early termination||||Participants|||Count of Participants
1311219|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
1311220|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 3.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
1311221|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
1311222|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Screening.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
1311223|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
1311224|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 12.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
1311225|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 days time-point.|||Percentage of participants|||Number
1311226|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.|||Percentage of participants|||Number
1311227|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 days time-point.|||Percentage of participants|||Number
1311228|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.|||Percentage of participants|||Number
1311229|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
1311230|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
1311231|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
1311232|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 30.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
1311233|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of participants|||Number
1311234|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of participants|||Number
1311235|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
1311236|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 3.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
1311237|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
1311238|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Screening.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
1311239|NCT02548078|Primary|Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs, for this endpoint, were assessed in subjects between 1-5 years of age, 6-12 years of age and 13-17 years of age.|During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311240|NCT02548078|Primary|Number of Subjects With Unsolicited Adverse Events (AEs), Overall|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited adverse events, for this endpoint, were assessed in all subjects, in both groups.|During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311284|NCT02547454|Secondary|Percentage of Participants With Iron Replacement|Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.|Up to 36 Months|Analysis population included all enrolled participants.|||Percentage of participants|||Number
1311241|NCT02548078|Primary|Number of Subjects With Solicited General Symptoms, by Age Stratum|Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. Symptoms with no values were not assessed for those specific age groups.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1311242|NCT02548078|Primary|Number of Subjects With Solicited General Symptoms, Overall|Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in all subjects, in both groups.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1311243|NCT02548078|Primary|Number of Subjects With Solicited Local Symptoms, by Age Stratum|Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm), for children between 1-5 years old; > 50 mm for children between 6-12 years old and >100 mm for children between 13-17 years old.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1311244|NCT02548078|Primary|Number of Subjects With Solicited Local Symptoms, Overall|Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm). Solicited local symptoms, for this endpoint, were assessed in all subjects, in both groups.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1311245|NCT02547974|Secondary|Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response|Frequency of specific CD8+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L). The frequency of specific CD8+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.|At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||CD8+ T-cells/million cells||Standard Deviation|Mean
1311246|NCT02547974|Secondary|Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response|Frequency of specific CD4+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as Interleukin [IL]-2, IL-13, IL-17, Interferon gamma [FN-γ], Tumour necrosis factor alpha [TNF-α] and CD40L). The frequency of specific CD4+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.|At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||CD4+ T-cells/million cells||Standard Deviation|Mean
1311247|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 38 EL.U/mL for anti-UspA2 antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1311285|NCT02547454|Secondary|Percentage of Participants With Dose 0|Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.|Up to 36 Months|Analysis population included all enrolled participants.|||Percentage of participants|||Number
1311248|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 16 EL.U/mL for anti-PilA antibodies.|At Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1311249|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 7 EL.U/mL for anti-PilA antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1311250|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 25 EL.U/mL for anti-PE antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1311251|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 153 EL.U/mL for anti-PD antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1311252|NCT02547974|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to study conclusion (Day 0 to Day 420)|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311253|NCT02547974|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to study conclusion (Day 0 to Day 420)|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311254|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 420, post-dose 2.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311255|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 210, post-dose 2.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311256|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 67, post-dose 2.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311286|NCT02547454|Secondary|Number of Dose Adaptations|Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).|Up to 36 Months|Analysis population included all enrolled participants.|||Events|||Number
1311257|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 60, post-dose 1.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311258|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 7, post-dose 1.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311259|NCT02547974|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period (Day 60 to Day 89) after second dose|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311260|NCT02547974|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period (Day 0 to Day 29) after first dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311261|NCT02547974|Primary|Number of Subjects With Any Solicited General Adverse Events (AEs)|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].|During a 7-day follow-up period (Day 60 to Day 66) after second dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311262|NCT02547974|Primary|Number of Subjects With Any Solicited General Adverse Events (AEs)|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].|During a 7-day follow-up period (Day 0 to Day 6) after first dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311263|NCT02547974|Primary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (Day 60 to Day 66) after second dose|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311264|NCT02547974|Primary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (Day 0 to Day 6) after first dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1311265|NCT02547714|Secondary|Percentage of Participants Achieving DLQI 0 or 1|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment."|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
1311266|NCT02547714|Secondary|Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 16|The full analysis set was considered for the analysis. Only participants who had both baseline and week 16 values were included in the analysis. The full analysis set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
1311347|NCT02545868|Secondary|Total Immunoglobulin||Days 1, 85, and 169|Safety population included all participants who received any ocrelizumab or any vaccine.|||grams per liter (g/L)||Standard Deviation|Mean
1311267|NCT02547714|Secondary|Percentage of Participants Achieving PASI 90 and Investigator’s Global Assessment (IGA) of 0 or 1 Response|"PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).~PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
1311268|NCT02547714|Secondary|Percentage of Participants Achieving PASI 50 or PASI 75|"PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).~PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively."|Week 4|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
1311269|NCT02547714|Secondary|Mean Percent Change From Baseline in PASI Score|PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). A negative change from baseline indicates improvement.|Week 4|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percent change||Standard Deviation|Mean
1311270|NCT02547714|Primary|Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)|PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 was defined as participants achieving >= 75% improvement from baseline.|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
1311271|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Vitreous (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous|Baseline, POD 90/Early termination||||Participants|||Count of Participants
1311272|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Choroid (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid|Baseline, POD 90/Early termination||||Participants|||Count of Participants
1311273|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Macula (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.|Baseline, POD 90/Early termination||||Participants|||Count of Participants
1311274|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Retina (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina|Baseline, POD 90/Early termination||||Participants|||Count of Participants
1311275|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc|Baseline, POD 90/Early termination||||Participants|||Count of Participants
1311276|NCT02547623|Secondary|Optic Disc Cup-disc Ratio for the Study Eye|Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).|Baseline, POD 90/Early termination||||ratio||Standard Deviation|Mean
1311277|NCT02547623|Secondary|Changes in the Corneal Endothelial Cell Count|Corneal Endothelial Cell Density was measured by specular microscopy.|Baseline, Postoperative day 90/Early termination||||cells/mm^2||Standard Deviation|Mean
1311278|NCT02547623|Secondary|Summary of Concomitant Medications Used in the Study Eye or Both Eyes||Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||Participants|||Count of Participants
1311279|NCT02547623|Secondary|Slit Lamp Biomicroscopy - Cornea Edema Grade|"Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator’s standard slit lamp equipment and procedure.~Cornea edema slit lamp results in the study eye were summarized by treatment group and time point."|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||Participants|||Count of Participants
1311280|NCT02547623|Secondary|Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade|"Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator’s standard slit lamp equipment and procedure.~Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point."|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||Participants|||Count of Participants
1312018|NCT02524418|Secondary|Strictures Found During the Procedure Will be Measured|The abnormalities found during the procedure, such as strictures.|Day 1|A total of 78 Cholangioscopic examinations were attempted|||strictures found|attempted Cholangioscopic exams||Number
1311287|NCT02547454|Secondary|Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.|Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months|Analysis population included all enrolled participants. Here, n signifies participants with available data at specified time-point.|||microgram||Full Range|Median
1311288|NCT02547454|Secondary|Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline|Baseline|Analysis population included all enrolled participants.|||microgram||Standard Deviation|Mean
1311289|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L||Up to 36 Months|Analysis population included all enrolled participants.|||Months||Full Range|Median
1311290|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L||Up to 36 Months|Analysis population included all enrolled participants.|||Months||Full Range|Median
1311291|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311292|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311293|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311294|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311295|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311296|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311297|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311298|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311299|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311300|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311301|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311302|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311303|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311304|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311305|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311306|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311307|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311308|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
1311309|NCT02547064|Secondary|Airway Injury|Larynx injury is assessed.|Intraoperative intubation||||Participants|||Count of Participants
1311310|NCT02547064|Secondary|Heart Rate|Heart rates are measured before and 2 min after intubation.|Intraoperative intubation||||beats per minute||Standard Deviation|Mean
1311311|NCT02547064|Secondary|Mean Blood Pressure|Mean blood pressure is measured before and 2 min after intubation.|Intraoperative intubation||||mmHg||Standard Deviation|Mean
1311312|NCT02547064|Secondary|Postoperative Sore Throat Measured Using Visual Analogue Scale|Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)|at 1, 24 hr postoperatively||||units on a scale||Standard Deviation|Mean
1311313|NCT02547064|Secondary|Thyromental Distance|The thyromental distance was measured.|Intraoperative anesthetic induction||||mm||Standard Deviation|Mean
1311314|NCT02547064|Secondary|Mallampati Grade|The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.|Intraoperative anesthetic induction||||Participants|||Count of Participants
1311315|NCT02547064|Secondary|Cormack-Lehan Grade|The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.|Intraoperative intubation||||Participants|||Count of Participants
1311316|NCT02547064|Secondary|Number of Participants for Whom External Laryngeal Manipulation Was Necessary|External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.|Intraoperative intubation||||Participants|||Count of Participants
1311317|NCT02547064|Secondary|Difficulty of Intubation Measured Using Visual Analogue Scale|Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).|Intraoperative intubation||||units on a scale||Standard Deviation|Mean
1311318|NCT02547064|Secondary|Success Rate of Intubation|The number of patients in which the intubation was successful at the first time.|Intraoperative intubation||||Participants|||Count of Participants
1311319|NCT02547064|Primary|Time to Intubation|Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)|Intraoperative intubation||||sec||Standard Deviation|Mean
1311320|NCT02546986|Secondary|Apparent Volume of Distribution (Vd/F) of CC-486|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1311321|NCT02546986|Secondary|Apparent Total Plasma Clearance (CL/F) of CC-486|Apparent total plasma clearance (CL/F) of CC-486 was calculated as Dose/AUC∞|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
1311322|NCT02546986|Secondary|Terminal Phase of Half-life (T1/2) of CC-486|Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 was only be calculated when a reliable estimate for λz could be obtained.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
1311323|NCT02546986|Secondary|Time to Maximum Plasma Concentration (Tmax) of CC-486|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||hours||Full Range|Median
1311324|NCT02546986|Secondary|Maximum Observed Plasma Concentration (Cmax) of CC-486|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1311348|NCT02545868|Secondary|Cellular Immune Response Assessed by Flow Cytometry|"Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul.~Repleted is defined as CD19 >= LLN or baseline, whichever is lower."|Days 1, 15, 85, 112, 140 and 169|Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for evaluable participants.|||percentage of participants|||Number
1311325|NCT02546986|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of CC-486|Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1311326|NCT02546986|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of CC-486|Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC % extrap is ≥25%, AUCi inf was not reported.|Pharmacokinetic (PK) blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1311327|NCT02546986|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on European Medicines Agency Methodology|Progression-free survival was defined according to EMA methodology as the time from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan result, not including symptomatic deterioration) or death for (any cause) on or prior to the data cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the last known time that the participant was progression free. However, occasional missing observations or initiation of subsequent new anticancer therapy would not result in censoring for this analysis. Progressive disease is at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.|From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm|The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.|||months||90% Confidence Interval|Median
1311328|NCT02546986|Secondary|Number of Participants With Treatment Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild; Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm|The safety population includes all participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
1311329|NCT02546986|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response|"The best overall response is defined as the percentage of participants who achieved an objective confirmed complete response or partial response according to RECIST v1.1, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on day 1 of study treatment.~RECIST v1.1 is defined as:~Complete response: disappearance of all target lesions~Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease~Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion."|Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBZ + PBO|The Intent-to-Treat population includes all participants who were randomized.|||Percentage of Participants||90% Confidence Interval|Number
1311330|NCT02546986|Secondary|Kaplan Meier Estimate of Overall Survival|Overall survival (OS) was defined as the time in months between day 1 of treatment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|From Day 1 of treatment up to the clinical cut-off date of 12 April 2017, whichever occurred earlier; median follow-up time for OS was 11.3 months in the CC-486 + PBZ arm and 12.2 months in the PBZ + Placebo arm|The Intent-to-Treat population includes all participants who were randomized.|||months||90% Confidence Interval|Median
1311331|NCT02546986|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for a Minimum Duration of 18 Weeks Compared to Baseline|"Disease control rate was defined as the percentage of participants who had confirmed stable disease, complete or partial response during the course of study, according to RECIST v1.1, as evaluated by the investigator.~RECIST v 1.1 is defined as:~Complete response: disappearance of all target lesions~Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease~Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion. When stable disease was believed to be the best response, it must have met the minimum duration of 10 weeks from randomization."|Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBO +PBZ|The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.|||Percentage of Participants||90% Confidence Interval|Number
1311349|NCT02545868|Secondary|MRI Parameters: Total Number of Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||lesions||Standard Deviation|Mean
1311332|NCT02546986|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology|PFS was defined according to the FDA Methodology as the time in months from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan, not including symptomatic deterioration) or death for (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment where the participant was documented to be progression-free prior to the data cutoff date. Progressive disease includes at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.|From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm|The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.|||months||90% Confidence Interval|Median
1311333|NCT02546609|Secondary|Change in Insulin Sensitivity (HOMA-IR)|HOMA-IR levels will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the change in geometric mean (SE) in HOMA-IR from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||mU/L||Standard Error|Geometric Mean
1311334|NCT02546609|Secondary|Change in C-reactive Protein|CRP levels will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the geometric mean change (SE) in C-reactive protein from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||mg/L||Standard Error|Geometric Mean
1311335|NCT02546609|Secondary|Change in Triglycerides|Lipid levels such as triglycerides will be examined by standard blood chemistry|Baseline, Day 112|Geometric mean values are presented since the data were skewed. Corresponding arithmetic mean changes from baseline for Treatments A, B and C in the Per Protocol Population were +54.9, -48.9 and -28.0 mg/dL respectively. This accounts for the p-value of p=0.0129 for Treatment B.|||mg/dL||Standard Error|Geometric Mean
1311336|NCT02546609|Secondary|Change in Low Density Lipoproteins (LDL)|Lipid levels such as LDL will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in LDL from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is because LDL could not be calculated for some participants.|||mg/dL||Standard Deviation|Mean
1311337|NCT02546609|Secondary|Change in Blood Lipids (High Density Lipoprotein:HDL)|Lipid levels such as HDL will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in LDL from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is because HDL could not be calculated for some participants.|||mg/dL||Standard Deviation|Mean
1311338|NCT02546609|Secondary|Change in Blood Lipids (Cholesterol)|Lipid levels such as cholesterol will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in total cholesterol from Baseline to Week 16 was assessed.|||mg/dL||Standard Deviation|Mean
1311339|NCT02546609|Secondary|Change in Insulin|Insulin levels will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in insulin from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||μIU/mL||Standard Deviation|Mean
1311340|NCT02546609|Secondary|Change in Fasting Glucose|Fasting glucose will be examined through standard fasting blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in fasting glucose from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||mg/dL||Standard Deviation|Mean
1311341|NCT02546609|Secondary|Change in Heamoglobin A1c (HbA1c)|HbA1c will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in HbA1c from Baseline to Week 16 was assessed.|||percentage||Standard Deviation|Mean
1311342|NCT02546609|Secondary|Change in Circulating Cytokeratin 18 Fragments (M30)|Change in Circulating Cytokeratin 18 Fragments (M30) from Baseline to Week 16 will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in circulating cytokeratin 18 fragments (M30, U/L) from Baseline to week 16 was assessed|||U/L||Standard Deviation|Mean
1311343|NCT02546609|Secondary|Change in Serum AlanineAaminotransferase (ALT) Levels|Serum AlanineAminotransferase (ALT) will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in serum ALT levels from Baseline to Week 16 was assessed|||U/L||Standard Deviation|Mean
1311344|NCT02546609|Primary|Change in Hepatic Fat|To evaluate the change in hepatic fat content assessed by proton-density-fat-fraction (PDFF) employing magnetic resonance imaging (MRI).|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean percent change (SD) in hepatic fat content (%) from Baseline to Week 16 (Day 112) for each treatment group was assessed.|||percentage||Standard Deviation|Mean
1311345|NCT02545868|Secondary|Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.|During ISP (24 weeks for Group A and 12 weeks for Group B)|Safety population included all participants who received any ocrelizumab or any vaccine.|||percentage of participants|||Number
1311346|NCT02545868|Secondary|Percentage of Participants With Anti-Drug Antibody Formation|Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.|Up to 24 Weeks (ISP)|Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for participants with measurable ADA samples.|||percentage of participants|||Number
1311354|NCT02545868|Secondary|MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.|||participants|||Number
1311355|NCT02545868|Secondary|MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||lesions||Standard Deviation|Mean
1311356|NCT02545868|Secondary|MRI Parameters: Categorical Number of T2 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.|||participants|||Number
1311357|NCT02545868|Secondary|MRI Parameters: Number of T2 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||lesions||Standard Deviation|Mean
1311358|NCT02545868|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cubic centimeters (cm^3)||Standard Deviation|Mean
1311359|NCT02545868|Secondary|Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination|Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.|Immediately prior to and 4 weeks after influenza vaccine|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||ratio||Standard Deviation|Geometric Mean
1311360|NCT02545868|Secondary|Strain-Specific Geometric Mean Titer Levels|Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.|Baseline and Week 4|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||hemagglutination inhibition titers||95% Confidence Interval|Geometric Mean
1311361|NCT02545868|Secondary|Percentage of Participants With Seroconversion|Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer <10 and an HI titer >40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer <10 and HI titer >/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer >/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.|4 weeks after influenza immunization|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
1311362|NCT02545868|Secondary|Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers|4-fold increase from prevaccination HI titer.|4 weeks after seasonal influenza vaccine administration|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
1311363|NCT02545868|Secondary|Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers|2-fold increase from prevaccination HI titer.|4 weeks after seasonal influenza vaccine administration|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
1311364|NCT02545868|Secondary|Percentage of Participants With Seroprotection|Seroprotection was defined as specific hemagglutination inhibition (HI) titers >40 at 4 weeks after vaccination.|4 weeks after seasonal influenza vaccine administration|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
1311365|NCT02545868|Secondary|Mean Level of Anti-Pneumococcal Antibody|Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).|Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||mcg/mL||95% Confidence Interval|Geometric Mean
1311366|NCT02545868|Secondary|Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.|8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
1311367|NCT02545868|Secondary|Mean Levels of Anti-Pneumococcal Antibody|Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).|Immediately prior to and 4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||mcg/mL||95% Confidence Interval|Geometric Mean
1311368|NCT02545868|Secondary|Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.|4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
1311369|NCT02545868|Secondary|Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.|4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
1311370|NCT02545868|Secondary|Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.|4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
1311371|NCT02545868|Secondary|Mean Levels of Anti-KLH Antibody: Ig M|Anti-KLH antibody levels were assessed by ELISA.|Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration|OC population included all randomized participants who completed the ISP.|||titer units||95% Confidence Interval|Geometric Mean
1311372|NCT02545868|Secondary|Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G|Anti-KLH antibody levels were assessed by ELISA.|Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration|OC population included all randomized participants who completed the ISP.|||titer units||95% Confidence Interval|Geometric Mean
1311373|NCT02545868|Secondary|Mean Levels of Anti-Tetanus Antibody|Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).|Immediately prior to and at 4 and 8 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||IU/mL||95% Confidence Interval|Geometric Mean
1311374|NCT02545868|Secondary|Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers|For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.|4 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
1311375|NCT02545868|Secondary|Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine|For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.|4 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
1311376|NCT02545868|Primary|Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine|For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.|8 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
1311377|NCT02545543|Secondary|Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Fold Change Titer (GMFI)||95% Confidence Interval|Geometric Mean
1311378|NCT02545543|Secondary|Immunogenicity Endpoint: Seroprotection Rate|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results|||percentage of participants||95% Confidence Interval|Number
1311379|NCT02545543|Secondary|Immunogenicity Endpoint: Seroconversion Rate (SCR)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||percentage of participants||95% Confidence Interval|Number
1311380|NCT02545543|Secondary|Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- Geometric mean of HI titers prevaccination & postvaccination"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results|||Titer||95% Confidence Interval|Geometric Mean
1311381|NCT02545543|Secondary|Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).|Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.|180 days after the last vaccination dose.|The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data|||participants|||Number
1311382|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).|Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose|28 days after each vaccination.|The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data.|||participants|||Number
1311383|NCT02545543|Secondary|Safety Endpoint: The Frequency of Cellulitis-like Reaction.|Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose|28 days after each vaccination.|The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.|||participants|||Number
1311384|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).|Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose|7 days after each vaccination.|The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.|||participants|||Number
1311398|NCT02545101|Secondary|Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)|symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient’s medical records|Baseline||||Participants|||Count of Participants
1311385|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.|Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose|7 days after each vaccination.|The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.|||participants|||Number
1311386|NCT02545543|Primary|The Difference in Seroconversion Rate (SCR) for Each Virus Strain.|Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.|28 days after last vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants||95% Confidence Interval|Number
1311387|NCT02545543|Primary|The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.|Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.|28 days after last vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Ratio||95% Confidence Interval|Geometric Mean
1311388|NCT02545322|Secondary|Volumetric Changes|"Percent changes in the volume of the Planning Target Volume (PTV). The Planning Target Volume is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose. The volumetric changes of the PTV throughout the course of Radiation therapy are evaluated. A significant change in the volume of the PTV (measured in ccm) might be an indicator for possible undesireable dosimetric alterations."|week 5||||percent||Standard Deviation|Mean
1311389|NCT02545322|Primary|Planning Target Volume (PTV) Coverage Parameter D98%|"Dose coverage of the planning target volume: Number of participants with a decrease in the planning target volume (PTV) coverage (D98%) above 5%. The Parameter D98% denotes the minimum dose to 98% of the volume according to the ICRU (International Commission on Radiation Units & Measurements) Report No. 62. It is a widely accepted classification index for dose coverage.~The Planing Target Volume is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose."|week 5||||participants|||Number
1311390|NCT02545101|Other Pre-specified|Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)|Only medications taken by more than 5% of the study population are presented|From 12 months up to baseline (tolvaptan treatment initiation)||||Participants|||Count of Participants
1311391|NCT02545101|Secondary|Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study|"Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient’s medical records (up to 6 weeks after the initiation of tolvaptan treatment).~For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered)."|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards||||days||Standard Deviation|Mean
1311392|NCT02545101|Secondary|Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia|symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient’s medical records|Baseline||||Participants|||Count of Participants
1311393|NCT02545101|Post-Hoc|Time (Days) to Hospital Discharge up to 6 Weeks After Treatment Start||From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards|"Originally, the idea was to analyse this out come in hours, but due to missing data, it was also analysed in days."|||days||95% Confidence Interval|Median
1311394|NCT02545101|Other Pre-specified|Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)|Only medications taken by more than 5% of the study population are presented|From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation||||Participants|||Count of Participants
1311395|NCT02545101|Secondary|Time (Days) to Sodium Normalisation|Time (days) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards||||days||95% Confidence Interval|Median
1311396|NCT02545101|Secondary|Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study|"Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient’s medical records (up to 6 weeks after the initiation of tolvaptan treatment).~For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered)."|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards||||mg||Standard Deviation|Mean
1311397|NCT02545101|Secondary|Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)|specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient’s medical records|Baseline||||% of participants|||Number
1311399|NCT02545101|Secondary|Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)|Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient’s medical records|Baseline||||% of participants|||Number
1311400|NCT02545101|Secondary|Time (Hours) to Sodium Normalisation|Time (hours) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards|"Exact time was available for 64 patients, so the analysis in hours had a n=64"|||hours||95% Confidence Interval|Median
1311401|NCT02545101|Secondary|Change in Sodium Levels 6 Weeks After Treatment Initiation|Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards|only patients with a value at both baseline and that time point are included in the change|||mmol/L||Standard Deviation|Mean
1311402|NCT02545101|Secondary|Change in Sodium Levels 24 Hours After Treatment Initiation|Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan|From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards|Only patients with a value at both baseline and 24 hours of initiation of tovaptan were included in the change from baseline|||mmol/L||Standard Deviation|Mean
1311403|NCT02545101|Primary|Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge|The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).|From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)|Baseline sodium level was not available for 4 patients|||mmol/L||Standard Deviation|Mean
1311404|NCT02544984|Other Pre-specified|Level of Cytokines|Using a standardize nasal wash procedure, respiratory samples will be collected at enrollment, at end of study, and during acute respiratory illness requiring face-to-face provider interaction. Children with a tracheostomy will have both a nasal wash sample and a tracheal aspirate sample collected. The respiratory samples will be stabilized with a universal transport media, processed and stored at -80 C for future testing. Testing will be performed for cytokines/chemokines; other biomarkers of disease such as LDH, MPO, and caspase; viral and bacterial respiratory pathogens; and microbiome.|8 months|||||||
1311405|NCT02544984|Other Pre-specified|Level of Airway Conductance|To determine if prophylactic use of azithromycin will reduce level of airway resistance as measured by an Airwave Oscillometry System in subjects above 2 years of age, at the time of respiratory illnesses, during the 3-6 months intervention.|6 months|||||||
1311406|NCT02544984|Other Pre-specified|Long Term Reduction in Respiratory Symptoms|To determine if prophylactic use of azithromycin will reduce the total number of unscheduled face-to-face physician visit for respiratory related illness in a clinic, urgent care, emergency room or hospital setting during the following 12 months after the intervention.|12 months|||||||
1311407|NCT02544984|Secondary|Healthcare Cost Associated With Respiratory Illness|Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.|5 to 8 months|Cost-effective analyses are only justified for interventions that are shown to be effective. Because the intervention at study (the macrolide azithromycin) showed no benefit and led to worse outcomes than those with usual care, an economic evaluation is not warranted and claims data was not collected.||||||
1311408|NCT02544984|Secondary|Number of Adverse Events|Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.|5 to 8 months||||adverse events|||Number
1311409|NCT02544984|Primary|Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)|Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.|5 to 8 months||||visits|||Number
1311410|NCT02544074|Secondary|eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score|The investigators will compare the eSAGE scores to the WAIS III Block Design scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311411|NCT02544074|Secondary|eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score|The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311412|NCT02544074|Secondary|eSAGE Score Compare to the FAS Verbal Fluency Task Score|The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311413|NCT02544074|Secondary|eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score|The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) total learning scores. Associations will be investigated using Spearman correlations. The investigators will also compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311414|NCT02544074|Secondary|eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score|The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1314924|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN||96 weeks||||participants|participants||Number
1311416|NCT02544074|Secondary|eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score|The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311417|NCT02544074|Secondary|eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score|The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311418|NCT02544074|Secondary|eSAGE Score Compared to the Paper SAGE Score|The investigators will compare the subject's scores on the SAGE in digital format to their paper SAGE scores to determine if these two formats are equivalent to each other. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
1311419|NCT02544074|Primary|eSAGE Score Compared to the Sum of the Neuropsychological Measures.|"Analysis will consist of comparing the subject’s scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include:~Boston Naming Test~Wisconsin Card Sort Task (WCST)~Hopkins Verbal Learning Test (HVLT)~FAS verbal fluency task~Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests~Associations will be investigated using Spearman correlations."|3 Hours||||spearman rank correlation|||Number
1311420|NCT02543918|Primary|Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations|"Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of >=1.0 (International Unit (IU) and a >=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is <=1.0 at baseline OR a >=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is > 1.0 IU at baseline.~Responder to the pneumococcal vaccine is defined as a >=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against >50% of the 23 serotypes."|Week 6|All randomized participants who completed the study.|||percentage of participants|||Number
1311421|NCT02543528|Secondary|Overall Vision Score|Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.|Time Frame Up to 6 months|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.|||Units on a Scale||Standard Deviation|Mean
1311422|NCT02543528|Secondary|Overall Comfort Score|Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.|Time Frame Up to 6 months|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.|||Units on a Scale||Standard Deviation|Mean
1311423|NCT02543528|Primary|Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)|The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.|Up to 6 months|The analysis population consists of all subjects that were enrolled into the extended wear period.|||Number of Events|Eyes||Number
1311424|NCT02543437|Secondary|Wear Rate(%)|Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.|1 year, 2 years, 3 years and 5 years after surgery|||||||
1311425|NCT02543437|Primary|Lift Off Distance in Dislocation Maneuver(mm)|Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|participants with available data : 100 hips in 100 participants.|||mm|Participants|Standard Deviation|Mean
1311426|NCT02543437|Primary|Range of Motion(ROM) (Degree)|Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants.|||Degree|Participants|Standard Deviation|Mean
1311427|NCT02543398|Primary|Radiographic Bone Changes|The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)|3 months after tooth extraction||||millimeter||Standard Error|Mean
1311428|NCT02542943|Secondary|Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1311429|NCT02542943|Secondary|Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (“No Pain”) to 10 (“Intense Pain”). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1311430|NCT02542943|Secondary|Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
1311431|NCT02542943|Secondary|Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a ‘yes’ response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
1311432|NCT02542943|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1311433|NCT02542943|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1311434|NCT02542943|Primary|Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
1311435|NCT02542761|Secondary|Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ)|The PEQ is a self-administered questionnaire composed of nine scales computed from forty-two items (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Each question uses a visual analog scale format, scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the measured from the left (0-100). The 0 side of the scale is very negative (terrible) and the 100 side of the scale is very positive (excellent). Each scale is reported separately, with a higher score indicating more satisfaction with the prosthesis itself or quality of life.|After approximate 4 week acclimation period|Some participants did not complete some of the scales in the questionnaire.|||units on a scale||Standard Deviation|Mean
1311436|NCT02542761|Secondary|Time of Peak Knee Flexion During Swing|A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is expressed as a percentage of the gait cycle.|After approximate 4 week acclimation period||||percentage of gait cycle||Standard Deviation|Mean
1311437|NCT02542761|Secondary|Peak Knee Flexion During Swing|A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is measuring the angle of knee flexion during the swing phase.|After approximate 4 week acclimation period||||degrees||Standard Deviation|Mean
1311459|NCT02542072|Secondary|Vision Quality|Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.|Baseline, 2 weeks, 4 weeks|Number of participants analyzed differ from participant flow due to protocol deviations.|||units on a scale||Standard Deviation|Mean
1314925|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN||96 weeks||||participants|participants||Number
1311438|NCT02542761|Secondary|Peak Ankle Power Generation|Joint power (P) is the “dot product” of the moment (M) at the joint and the angular velocity (w) of the distal segment with respect to the proximal segment (i.e., P = M · w). Depending on the direction of the moment and the direction of the angular velocity, the power can be positive or negative. If the signs for the moment and angular velocity are both positive or both negative, the power is positive. If the signs for the moment and angular velocity are different, the power is negative. The unit of measurement for this variable is W/kg = watts/kilogram.|After approximate 4 week acclimation period||||W/kg||Standard Deviation|Mean
1311439|NCT02542761|Secondary|Peak Ankle Plantar Flexor Moment During Stance|Peak ankle plantar flexor moment means the peak force of the movement of the foot in which the foot or toes flex downward toward the sole. The unit of measurement for this variable is Nm/kg = 1 nanometer / (kilogram unit).|After approximate 4 week acclimation period||||Nm/kg||Standard Deviation|Mean
1311440|NCT02542761|Primary|Peak Ankle Dorsiflexion During Stance|The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.|After approximate 4 week acclimation period||||degrees||Standard Deviation|Mean
1311441|NCT02542462|Primary|The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits|Study will be determined to be feasible on a larger scale if 70% or more of randomized subjects complete all study visits and remain in the study until completion|15 months|All randomized subjects, irrespective of arm assignment|||Participants|||Count of Participants
1311442|NCT02542462|Primary|The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled)|Study will be determined to be feasible on a larger scale if 10% or more of eligible subjects enroll in the study|15 months|During the study period, there were 252 children screened and of these, 238 were eligible for enrollment. These subjects were identified through screening at a primary care clinic and through advertisement.|||Participants|||Count of Participants
1311443|NCT02542462|Primary|The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy|Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)|4- 6 days|Subjects had an abdominal MRI followed by an abdominal ultrasound prior to receiving vaccines at Day 0 (Visit 1). They returned 4-6 days later for follow up MRI and Ultrasound post vaccination (Visit 2) Terminal ileum thickness was measured and compared pre-post. Abdominal lymph nodes seen on ultrasound were compared pre-post|||Participants|||Count of Participants
1311444|NCT02542280|Primary|Clinical Pregnancy Rate|Ultrasound detection of an intrauterine positive fetal heart pulsations|six weeks||||participants|||Number
1311445|NCT02542280|Primary|Chemical Pregnancy Rate|Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.|two weeks after intrauterine insemination||||participants|||Number
1311446|NCT02542072|Secondary|Dryness|Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
1311447|NCT02542072|Secondary|Overall Fit Acceptance|Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
1311448|NCT02542072|Secondary|Lens Tightness Push-up|"Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.~Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support"|Baseline, 2 weeks, 4 weeks||||percentage of mean lens tightness|Eyes|Standard Deviation|Mean
1311449|NCT02542072|Secondary|Primary Gaze Lag|Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement|Baseline, 2 weeks, and 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
1311450|NCT02542072|Secondary|Post-Blink Movement|Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement|Baseline, 2 weeks, 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
1311451|NCT02542072|Secondary|Corneal Coverage|"Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.~Yes = coverage at all times or No = coverage incomplete"|Baseline Visit, 2 weeks follow-up, 4-weeks follow-up||||percentage of eyes|Eyes||Number
1311452|NCT02542072|Secondary|Lens Centration|Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)|Baseline, 2 weeks, 4 weeks||||Eyes|Eyes||Number
1311453|NCT02542072|Secondary|Visual Acuity (VA)|Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.|Baseline, 2 weeks, 4 weeks||||LogMAR||Standard Deviation|Mean
1311454|NCT02542072|Secondary|White Spot Deposits|Number of white spot deposits for comfilcon A and samfilcon A lenses.|2 weeks and 4 weeks||||number of white spots|Eyes|Standard Deviation|Mean
1311455|NCT02542072|Secondary|Film Deposits|Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.|2 weeks and 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
1311456|NCT02542072|Secondary|Lens Surface Wetting|Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent|Baseline, 2 weeks, 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
1311457|NCT02542072|Secondary|Biomicroscopy Scores|Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, 2 weeks, 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
1311458|NCT02542072|Secondary|Overall Lens Handling|Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
1311460|NCT02542072|Secondary|Deterioration in Comfort|Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent|Baseline, 2 weeks, 4 weeks||||participants|||Number
1311461|NCT02542072|Secondary|Wearing Times|Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.|Baseline, 2 weeks, 4 weeks||||hours||Standard Deviation|Mean
1311462|NCT02542072|Secondary|Comfortable Wearing Time Via SMS (Short Message Service)|Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).|Days 3, 12, 26|Number of participants analyzed may differ from participant flow due to protocol deviations.|||units on a scale||Standard Deviation|Mean
1311463|NCT02542072|Primary|Comfort|Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).|Baseline, 2 weeks, 4 weeks|Number of participants analyzed is different from participant flow due to protocol deviations.|||units on a scale||Standard Deviation|Mean
1311464|NCT02541864|Primary|Number of Participants in Which H. Pylori Was Eradicated|Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.|at the 6th week after the end of anti- H. pylori therapy|Intention to treat|||participants|||Number
1311465|NCT02541422|Primary|Hangover Symptom Scale|"In the morning, each participate will fill out a Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 – 4 point Hangover Symptom Severity scale. 0 representing strongly disagree or feels like I did not drink last night to 4 representing strongly agree or I'm so hungover / I'm never drinking again for each symptom. The symptoms on the Hangover Symptom Scale are: feeling thirsty or dehydrated, feeling more tired than usual, headache, nauseated, vomited, feeling weak, difficulty concentrating, more sensitive to light and sound than usual, sweating more than usual, had trouble sleeping, feeling anxious, feeling depressed, experienced trembling or shaking. The total score could range from 0-52 with 0 being no symptoms of hangover and 52 being the worst symptoms of hangover. This study looked specifically at the overall hangover score, nauseated, feeling weak and headache."|12 hours or less||||units on a scale||Full Range|Median
1311466|NCT02540850|Secondary|Consistency (the Overall Ratio of True Positive and True Negative)|The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases|1 year||||percentage of true pos&negs in all cases|||Number
1311467|NCT02540850|Secondary|Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population)|the ratio of positive cases in all cases|1 year||||percentage of positives in each group|||Number
1311468|NCT02540850|Secondary|NPV (the Negative Predictive Value of mSEPT9 Assay in the Population)|the ratio of true negative in all negative cases|1 year||||percentage of true negs in all neg cases|||Number
1311469|NCT02540850|Secondary|PPV (the Positive Predictive Value of mSEPT9 Assay in the Population)|the ratio of true positive in all positive cases|1 year||||percentage of true pos in all pos cases|||Number
1311470|NCT02540850|Secondary|Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases))|the ratio of negative cases in all non-CRC or NED cases|1 year||||percentage of true negs in non-CRC group|||Number
1311471|NCT02540850|Secondary|Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer)|the ratio of positive cases in all CRC cases|1 year||||Percentage of positives in disease group|||Number
1311472|NCT02540850|Primary|Ct Value (Ct Values From PCR Reaction)|the number of PCR cycles where the amplification signal starts to be observed|1 year||||Ct||95% Confidence Interval|Mean
1311473|NCT02540772|Secondary|Number of Errors in Source Attribution|"After the recall of the material, patients were also asked to remember which modality corresponded to each recall (i.e., seen, heard or imagined), and who had presented the material during the learning session (i.e., the therapist or themselves).~Scores ranged from 0 (if all answers were non-responses) to unlimited number (depending on number of confabulations produced by patients).~The values in the table represent the mean of errors in source attribution for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).|||Errors in source attribution||Standard Deviation|Mean
1311474|NCT02540772|Primary|Number of Non-responses|"Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).~The values in the table represent the mean of non-responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).|||Non-responses||Standard Deviation|Mean
1311475|NCT02540772|Primary|Number of Correct Responses|"Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).~The values in the table represent the mean of correct responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of previous outcome measure data, i.e., confabulations).|||Correct responses||Standard Deviation|Mean
1314926|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN||96 weeks||||participants|participants||Number
1311476|NCT02540772|Primary|Number of Confabulations|"The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses.~Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the baseline. The values in the table represent the mean of confabulations for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|We used preliminary data from the first 5 patients using the G*Power software to calculate the sample size. From them, to detect differences through a Student t-test considering the significance level is 5%, the sample size was estimated in 7 subjects per group with an alpha of 0.95. We expanded to 10 to ensure greater power.|||Confabulations||Standard Deviation|Mean
1311477|NCT02540447|Secondary|3 Months Mortality|mortality within first 3 post-operative months|3 Months||||participants|||Number
1311478|NCT02540447|Secondary|Post-operative Infectious Complications||30 days||||participants|||Number
1311479|NCT02540447|Secondary|Ischemia Reperfusion Injury|incidence of ischemia reperfusion injury in the transplanted graft|7 days||||participants|||Number
1311480|NCT02540447|Secondary|Biliary Complications (Participants)|Participants who developed biliary complications in three months period (Participant)|3 months||||participants|||Number
1311481|NCT02540447|Primary|Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure|The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping|5 minutes post-reperfusion||||mmHg||Standard Deviation|Mean
1311482|NCT02540434|Secondary|Time to Product Administration|Time from request to administration of study product|Procedure length, the average for participants is approximately 6 hours|||||||
1311483|NCT02540434|Secondary|Correlation of Laboratory and ROTEM Data|Correlation of fibrinogen, von Willebrand Factor (vWF), and factor VIII levels measured in traditional lab with intraoperative ROTEM parameters|Procedure length, the average for participants is approximately 6 hours|||||||
1311484|NCT02540434|Secondary|Mortality Rate|Rate of hospital death during initial hospital admission.|Length of Hospital Stay, the average for participants is approximately 7 days|||||||
1311485|NCT02540434|Secondary|Incidence of Re-exploration|Incidence of subjects requiring a return to the OR for re-exploration.|Length of Hospital Stay, the average for participants is approximately 7 days|||||||
1311486|NCT02540434|Secondary|Blood Loss|Quantity of intraoperative and postoperative blood loss as recorded in the anesthesia record and in chest tube outputs (blood drainage volume)|Length of Hospital Stay, the average for participants is approximately 7 days,|||||||
1311487|NCT02540434|Secondary|Infection and Respiratory Failure|Incidence of any infection or respiratory failure from procedure end to hospital discharge.|Length of Hospital Stay, the average for participants is approximately 7 days|||||||
1311488|NCT02540434|Secondary|Thrombosis and Transfusion Reactions|Incidence of intraoperative or postoperative (during hospital admission only) thrombosis (symptomatic only) and transfusion reactions from procedure to hospital discharge.|Length of Hospital Stay, the average for participants is approximately 7 days|||||||
1311489|NCT02540434|Secondary|Hospital Length of Stay|Number of days subject spends in the hospital from procedure end to hospital discharge|Length of Hospital Stay, the average for participants is approximately 7 days|||||||
1311490|NCT02540434|Secondary|CTICU Length of Stay|Number of days subject spends in cardiothoracic intensive care unit from procedure end to hospital discharge|Length of Hospital Stay, the average for participants is approximately 7 days|||||||
1311491|NCT02540434|Secondary|Correction of Microvascular Bleeding|Difference in surgeon’s assessment of microvascular bleeding from approximately 15 minutes before to approximately 15 minutes after administration of study medication|~30 min intraoperatively|||||||
1311492|NCT02540434|Secondary|Incidence of Zero Transfusions|Number of patients who receive no allogeneic blood transfusions following study product administration and first 24 hours after procedure end.|24 hours|||||||
1311493|NCT02540434|Secondary|Fibrinogen Repletion|Fibrinogen repletion as measured by ROTEM FIBTEM >10mm after study product administration|Procedure length, the average for participants is approximately 6 hours|||||||
1311494|NCT02540434|Secondary|24-hour Blood Transfusion Total|Number of units of RBC, Platelets, cryoprecipitate, FFP, or other blood products administered to subjects receiving study product within the first 24 hours after procedure end|24 hours|||||||
1311495|NCT02540434|Primary|Intraoperative Blood Transfusion Total|The combined number of allogeneic blood products (platelets + Fresh Frozen Plasma (FFP) + RBCs) administered to subjects intraoperatively after study intervention.|Procedure length, the average for participants is approximately 6 hours|Only 1 subject out of total enrolled were randomized. This one subject was randomized to cryoprecipitate arm. Due to this only 1 subject being randomized and the study being terminated before completion, no data analysis was done to assess the primary outcome. Therefore there is no measurable data for the mean and SD in either arm.||||||
1311496|NCT02540356|Secondary|Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Questionnaire|QoL will be assessed using EORTC QLQ-C30.|Weekly from the baseline visit to the last week of safety follow-up (8 weeks or longer, if additional treatment will be implemented)|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311497|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Volume of Distribution (V)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311575|NCT02537730|Secondary|Dryness|Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week||||units on a scale||Standard Deviation|Mean
1311498|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Apparent Systemic Clearance (CL)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311499|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Half-life (t1/2)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311500|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Area Under the Concentration vs Time Curve (AUC)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311501|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Minimum Observed Concentration (Cmin)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311502|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311503|NCT02540356|Secondary|Occurrence of Binding and/or Neutralizing Anti-imalumab (BAX69) Antibodies Following Treatment With Imalumab (BAX69)||Throughout the study period of approximately 22 months|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311504|NCT02540356|Secondary|Occurrence of Serious Adverse Events (SAEs) and/or Treatment-emergent Adverse Events (TEAEs), Regardless of Causality or Relationship to Study Drug||Throughout the study period of approximately 22 months|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.|||Participants|||Count of Participants
1311505|NCT02540356|Secondary|Changes in Ascites-related Symptoms|Ascites related symptoms: anorexia, nausea, early satiety, vomiting, abdominal pain, abdominal swelling, dyspnea, fatigue, swollen ankles, heartburn|Baseline, weekly during the treatment period, and every 2 weeks during the safety follow-up period, up to approximately 6 months)|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311506|NCT02540356|Secondary|Change in Ascites Volume Per Unit Time With Treatment|The volume of ascites from the last dose of Imalumab to the first post-treatment paracentesis per unit time will be compared to the volume of the last pre-treatment paracentesis per unit time. At each paracentesis, the volume of fluid that can be removed safely (measured by ultrasound-guided paracentesis) to achieve close to dryness should be withdrawn, measured, and documented.|Up to 4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311507|NCT02540356|Secondary|Ratio of Time to First Paracentesis Post-treatment Over Puncture-free Interval at Baseline|Time to first paracentesis post-treatment is calculated as the time between the last dose of Imalumab to subsequent first therapeutic paracentesis.|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311508|NCT02540356|Primary|The Ratio of Puncture Free Survival (PuFS) Over Puncture-free Interval at Baseline|"PuFS is defined as the time from the last dose of Imalumab to the first therapeutic paracentesis after that, or death, whichever occurs first.~Puncture-free interval at baseline is calculated as the time between the last 2 therapeutic paracenteses immediately before the first dose of Imalubmab."|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
1311509|NCT02540356|Primary|The Occurrence of Dose-limiting Toxicity (DLT)|"DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria:~Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure in 7 days; Transient grade 3 elevations of hepatic transaminases in the absence of simultaneous increase in serum bilirubin; Alopecia)~Any toxicity resulted in dose delay for ≥14 days~Any grade 4 hematologic toxicity (except lymphopenia)~Grade 3 febrile neutropenia~Grade 3 thrombocytopenia associated with bleeding~Any life-threatening complication/abnormality not covered in the NCICTCAE v4.03"|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.|||Participants|||Count of Participants
1311510|NCT02540265|Secondary|Number of Subjects With Use of Rescue Medication (Oral Opioids)||48 hours|mITT analysis set|||Participants|||Count of Participants
1311525|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 7|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1314927|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN||96 weeks||||participants|participants||Number
1311511|NCT02540265|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.|48 Hours|mITT analysis set|||units on a scale||Standard Error|Least Squares Mean
1311512|NCT02540265|Secondary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.|48 Hours|mITT analysis set|||units on a scale||Standard Error|Least Squares Mean
1311513|NCT02540265|Secondary|Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Effect size was estimated based on SPID48 derived using 2-hour windowed last observation carried forward (W2LOCF) method and an analysis of covariance (ANCOVA) model that included treatment and baseline PI score.|48 Hours|All subjects treated with ≥1 dose of study medication and who had baseline PI and at least one post baseline PI (mITT analysis set; efficacy analysis set)|||units on a scale||Standard Error|Least Squares Mean
1311514|NCT02540265|Primary|Number of Subjects With Adverse Events|Number of subjects reporting treatment emergent adverse events|Through Day 30 Follow-up|All subjects treated with ≥1 dose of study medication (Safety analysis set)|||Participants|||Count of Participants
1311515|NCT02540213|Primary|Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment|Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Participant Satisfaction Set. Here, n = participants evaluable for specified timeframe.|||percentage of participants|||Number
1311516|NCT02540213|Primary|Mean Monthly Administrations of MIRCERA||9 months|Efficiency Set included all participants who had at least one MIRCERA application, without any major protocol violation and had prescription and application data available for 2 months before start of MIRCERA and first 2 months of study. Here N = participants who were evaluable for this outcome measure.|||MIRCERA administrations per month||Standard Deviation|Mean
1311517|NCT02540213|Primary|Number of MIRCERA Dose Adaptations||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||dose adaptations||Standard Deviation|Mean
1311518|NCT02540213|Primary|Average Monthly Dose of MIRCERA||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||grams||Standard Deviation|Mean
1311519|NCT02540213|Primary|Percentage of Participants Who Continued Treatment After End of Study||End of observation period (Month 9)|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1311520|NCT02540213|Primary|Percentage of Participants Who Reported Easement of Therapy With MIRCERA||9 months|Participant Satisfaction Set.|||percentage of participants|||Number
1311521|NCT02540213|Primary|Change From Baseline in Pain Sensation Using Visual Analogue Scale|Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)’ minus ‘pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application.|Baseline, Months 1-9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure and n = participants evaluable for specified timeframe.|||units on a scale||Standard Deviation|Mean
1311522|NCT02540213|Secondary|Change From Baseline in Hemoglobin (Hb) Concentration||Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Secondary endpoint set included all participants who had at least one MIRCERA application, without any major protocol violation and had at least 6 months documentation and minimum 2 of the 3 visits non-missing Hb and dosing data from Month 7 to 9 visits. N=participants evaluable for this outcome and n=participants evaluable for specified timeframe.|||g/dL||Standard Deviation|Mean
1311523|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1311524|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 8|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1312334|NCT02511782|Primary|CXCL10 in Skin|D-sqaume epidermal discs were used to assess CXCL10 levels from skin.|At time of GVHD diagnosis.|We did not analyze all acute GVHD samples for financial reasons.|||Skin CXCL10 femtograms/micrograms||Standard Error|Mean
1311526|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 6|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1311527|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 5|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1311528|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 4|Participant Satisfaction Set. Here N = participants who were available for this outcome measure.|||percentage of participants|||Number
1311529|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 3|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1311530|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 2|Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1311531|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 1|Participant Satisfaction Set.|||percentage of participants|||Number
1311532|NCT02540213|Primary|Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.|Baseline|Participant Satisfaction Set included all participants who had at least one MIRCERA application, without any major protocol violation and had satisfaction rating documented for previous ESA and MIRCERA.|||percentage of participants|||Number
1311533|NCT02539992|Secondary|Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
1311534|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
1311535|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).|"The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by no problem in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
1311536|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.|The FJS consists of 12 questions and focuses on the patients’ awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
1311537|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.|KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
1311538|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test|"Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.~One source suggests that scores of ten seconds or less indicate normal mobility, 11 – 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls."|1 year|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||seconds||Standard Deviation|Mean
1311539|NCT02539992|Primary|Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.|To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.|6 months|Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.|||Degrees||Standard Deviation|Mean
1311540|NCT02539797|Primary|Change From Baseline in Managing Emotions on MSCEIT|Total score on the Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) The test consists of 141 items and 8 ability subtests, which assess four components of emotional processing. In this study, only branches 1 and 4 were administered, focusing on the Managing Emotions component. The total score reflects mean performance across the branches. The scores were converted to normed T-scores that have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of better performance.|baseline and 20 minutes||||T-scores||Standard Error|Mean
1311541|NCT02539797|Primary|Change From Baseline in Cognition on MCCB|Summary score of the cognitive domains on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). Four nonsocial neurocognitive tasks were included: speed of processing, working memory, verbal memory, and reasoning/problem solving. Normed T-scores were calculated for each cognitive subdomain, as well as the cognitive composite score consisting of the average across the four subdomains. The T-scores have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of higher cognition.|baseline and 20 minutes||||T-scores||Standard Error|Mean
1311542|NCT02539654|Primary|Terminal Elimination Half-life (T1/2)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||hours||Standard Deviation|Mean
1311543|NCT02539654|Primary|Time to Last Measurable Concentration (Tlast)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||hours||Full Range|Median
1311544|NCT02539654|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||ng*h/mL||Standard Deviation|Mean
1311545|NCT02539654|Primary|Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||ng*h/mL||Standard Deviation|Mean
1311573|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits [Visits 7-9]).|||percentage of participants|||Number
1311574|NCT02537730|Secondary|Stinging and Burning Sensation|Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.|Baseline||||units on a scale||Standard Deviation|Mean
1311546|NCT02539654|Primary|Time to Reach Maximum Concentration (Tmax)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||hours||Full Range|Median
1311547|NCT02539654|Primary|Maximum Analyte Plasma Concentration (Cmax)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||ng/mL||Standard Deviation|Mean
1311548|NCT02539134|Secondary|AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Over the Dosing Interval for TAK-935||Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration. No data was reported for Cohorts 3 and 4 since dosing was discontinued after Day 10.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1311549|NCT02539134|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935||Day 1: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set where Day 1 assessment for AUC∞ was available. The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1311550|NCT02539134|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1311551|NCT02539134|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1311552|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1311553|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1311554|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1311555|NCT02539134|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)||Day 1 up to Day 28|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1311556|NCT02539108|Secondary|Geometric Mean Titer Ratios of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1311557|NCT02539108|Secondary|Number of Participants Who Achieved Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-final vaccination titer.|28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1311558|NCT02539108|Secondary|Number of Participants Who Achieved Seroprotection to Influenza Virus Antigens Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as a pre-vaccination or post-vaccination influenza antibody titer of ≥ 1:40 (1/dilutions).|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1311559|NCT02539108|Secondary|Geometric Mean Titers of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1312335|NCT02511587|Secondary|TBE Titer Profile|TBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)|before (day 0) and 1week, 1 month, 6 months after booster vaccination||||Geometric mean titers||95% Confidence Interval|Geometric Mean
1311560|NCT02539108|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine.|"Solicited injection-site reactions for 6 to < 36 months: Tenderness, Erythema, and Swelling. For 3 to < 9 years: Pain, Erythema, and Swelling. Solicited systemic reactions for 6 to < 36 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. For 3 to < 9 years: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 for 6 to < 36 months: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Vomiting, 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.~Grade 3 for 3 to < 9 years: Pain, Incapacitating; Erythema and Swelling, ≥ 50 mm; Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, prevents daily activity."|Day 0 up to Day 7 post any vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1311561|NCT02538679|Primary|Morphine Requirement|Compare ultrasound-guided block of the transversus abdominis plane (TAP) vs laparoscopic-guided TAP block, versus no TAP block on opioid consumption in the first 24 hours. Patients hospital chart was queried for use of any intravenous opioid in the first 24 hours after surgery including fentanyl or hydromorphone and conversion to morphine per standard opioid dose conversion. Total morphine equivalents then summed for the 24 hour postoperative period and compared between groups.|24 hours||||mg||Standard Deviation|Mean
1311562|NCT02538107|Primary|Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment||Up to 50 months|Efficacy analysis set. Participants with non-missing values were included.|||months||Standard Deviation|Mean
1311563|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
1311564|NCT02538107|Secondary|Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)|GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
1311565|NCT02538107|Secondary|Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study|Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
1311566|NCT02538107|Secondary|Hemoglobin Level Based on the Etiology of Chronic Kidney Disease|Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
1311567|NCT02538107|Secondary|Hemoglobin Level Based on the Presence of Inflammatory Diseases|Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
1311568|NCT02538107|Secondary|Hemoglobin Level Based on the Type of Kidney Transplantation Performed|Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
1311569|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
1311570|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
1311571|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
1311572|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set.|||percentage of participants|||Number
1311576|NCT02537730|Secondary|Comfort|Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week||||units on a scale||Standard Deviation|Mean
1311577|NCT02537730|Primary|Ocular Health - Corneal Staining|Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.|1 week||||Eyes|Participants||Number
1311578|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Corneal Diameter|Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.|||Pearson Correlation|||Number
1311579|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Keratometry|CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.|||Pearson Correlation|||Number
1311580|NCT02536781|Secondary|VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)||Days 0 and 7 after treatment||||units on a scale||Standard Deviation|Mean
1311581|NCT02536781|Primary|Wound Size (mm^2) Reduction|Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment|Days 0 and 7 after treatment||||mm^2||Standard Deviation|Mean
1311582|NCT02536664|Secondary|Percentage of Participants With Initiation of New Therapy|Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants|||Number
1311583|NCT02536664|Secondary|Percentage of Participants With Best Overall Response|The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
1311584|NCT02536664|Secondary|Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy|CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants|||Number
1311585|NCT02536664|Secondary|Median Overall Survival (OS) Time|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||months||95% Confidence Interval|Median
1311586|NCT02536664|Secondary|Percentage of Participants Who Were Alive|Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
1311601|NCT02535416|Secondary|Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||1/hr||Standard Deviation|Mean
1314928|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN||96 weeks||||participants|participants||Number
1311587|NCT02536664|Secondary|Median Progression Free Survival (PFS) Time|PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||months||95% Confidence Interval|Median
1311588|NCT02536664|Primary|Percentage of Participants Who Were Alive and Free From Progressive Disease|Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
1311589|NCT02536313|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1311590|NCT02536313|Secondary|HCV RNA Change From Baseline/Day 1 Through Week 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1311591|NCT02536313|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 1, 2, 4, 8 and 12|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1311592|NCT02536313|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1311593|NCT02536313|Primary|Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who took at least 1 dose of study drug|||percentage of participants|||Number
1311594|NCT02536313|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of study drug.|||percentage of particpants||95% Confidence Interval|Number
1311595|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
1311596|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire|The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
1311597|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
1311598|NCT02535741|Secondary|Investigation of Patient Outcome With Radiographic Analysis|Plain radiographs will be obtained for assessment of fixation of the device.|Pre-operative, 3 months, 1, 2 and 5 years follow-up|Radiographic data were not collected||||||
1311599|NCT02535741|Primary|Mean Triathlon CR Active Range of Motion (ROM)|Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.|2 years follow-up|Comparison to data from the literature was not done.|||degree||Standard Deviation|Mean
1311600|NCT02535416|Secondary|Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||hour||Standard Deviation|Mean
1312336|NCT02511587|Secondary|Cellular Immune Responses - Cytokines|cytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)|before (day 0) and 1 week after booster vaccination||||pg/ml||Standard Deviation|Mean
1311602|NCT02535416|Secondary|Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||mL/kg||Standard Deviation|Mean
1311603|NCT02535416|Secondary|Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||mL/hr/kg||Standard Deviation|Mean
1311604|NCT02535416|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||ng/mL||Standard Deviation|Mean
1311605|NCT02535416|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||ng.hr/mL||Standard Deviation|Mean
1311606|NCT02535416|Secondary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||ng.hr/mL||Standard Deviation|Mean
1311607|NCT02535416|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting hepatitis B virus [HBV]) and melittin-like peptide (MLP).|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one pharmacokinetic (PK) sample collected|||ng.hr/mL||Standard Deviation|Mean
1311608|NCT02535416|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product.|post-dose through the end of study (Day 15 ± 1 day) plus 30 days|Safety Population: all enrolled participants|||participants|||Number
1311609|NCT02535364|Secondary|Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015|Percentage of participants who developed anti-therapeutic antibodies against JCAR015|Part B Screening; Day 14 after the first JCAR015 infusion; Pre-Dose Day 1 of the second JCAR015 infusion; Day 14 after the second JCAR015 infusion; and Day 28, Month 3, Month 6, and Month 12 after the last JCAR015 infusion|The analysis population includes all enrolled subjects who underwent leukapheresis and had a sample that was evaluable for the assay.|||percentage of participants|||Number
1311610|NCT02535364|Secondary|AUC for JCAR015 in the Peripheral Blood as Measured by Flow Cytometry|AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by flow cytometry of the JCAR015 CAR. AUC calculation includes PK results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion.|Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion|The analysis population includes all participants who received at least one infusion of JCAR015.|||cells*days/microliter||Full Range|Median
1311611|NCT02535364|Secondary|Area Under the Concentration-vs-Time Curve (AUC) for JCAR015 in the Peripheral Blood as Measured by qPCR|AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by qPCR of the JCAR015 transgene. AUC calculation includes pharmacokinetic (PK) results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion.|Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion|The analysis population includes all participants who received at least one infusion of JCAR015.|||vector copy number*days/microgram||Full Range|Median
1311612|NCT02535364|Secondary|Tmax in the Peripheral Blood as Measured by Flow Cytometry|Tmax is defined as the time after the JCAR015 infusion at which the Cmax as measured by flow cytometry of the JCAR015 CAR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015 and whose Cmax was >0.|||days||Full Range|Median
1311613|NCT02535364|Secondary|Time to Maximum Concentration of JCAR015 (Tmax) in the Peripheral Blood as Measured by qPCR|Tmax is defined as the time after the JCAR015 infusion at which the maximum concentration (Cmax) as measured by qPCR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015.|||days||Full Range|Median
1314929|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN||96 weeks||||participants|participants||Number
1311614|NCT02535364|Secondary|Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Flow Cytometry|Cmax is defined as the highest measured concentration of JCAR015 CAR T cells per microliter of peripheral blood as measured by flow cytometry.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015.|||cells/microliter||Full Range|Median
1311615|NCT02535364|Secondary|Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Quantitative Polymerase Chain Reaction (qPCR)|Cmax is defined as the highest measured number of copies of JCAR015 transgene per microgram of genomic DNA in peripheral blood cells as assessed by qPCR.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015.|||vector copy number/microgram||Full Range|Median
1311616|NCT02535364|Secondary|Percentage of Participants Who Achieved a Morphologic Remission Within 6 Months After the Final JCAR015 Infusion and Then Proceeded to HSCT|Percentage of participants who achieved a morphologic remission within 6 months after the final JCAR015 infusion and then proceeded to HSCT prior to 12 months after the final JCAR015 infusion|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who were evaluable for response.|||percentage of participants||95% Confidence Interval|Number
1311617|NCT02535364|Secondary|Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC, at Month 6 After the Final JCAR015 Infusion|ORR at Month 6 is defined as the percentage of participants who achieved a CR or CRi at Month 6 after the final JCAR015 infusion without HSCT during the time period between the final JCAR015 infusion and the Month 6 response assessment (refer to Outcome Measure #1 for criteria for CR and CRi).|Day 1 (first JCAR015 infusion) up to 6 months after the last JCAR015 infusion|The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||percentage of participants|||Number
1311618|NCT02535364|Secondary|Duration of Remission (DOR) as Determined by an IRC|DOR is defined as the interval from the first documentation of CR or CRi to the earlier date of relapse or death due to ALL.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.|||months||95% Confidence Interval|Median
1311619|NCT02535364|Secondary|OS|OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
1311620|NCT02535364|Secondary|Overall Survival (OS)|OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
1311621|NCT02535364|Secondary|EFS|EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
1311622|NCT02535364|Secondary|Event-Free Survival (EFS)|EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
1311623|NCT02535364|Secondary|RFS, as Determined by an IRC|RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.|||months||95% Confidence Interval|Median
1311624|NCT02535364|Secondary|Relapse-Free Survival (RFS), as Determined by an IRC|RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to hematopoietic stem cell transplant (HSCT) after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.|||months||95% Confidence Interval|Median
1311625|NCT02535364|Secondary|Percentage of Participants Who Achieved a MRD-Negative CR or CRi|Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a PCR-based assay.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||percentage of participants|||Number
1311626|NCT02535364|Secondary|Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi|Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a polymerase chain reaction (PCR)-based assay.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||percentage of participants|||Number
1311627|NCT02535364|Secondary|Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC|BOR is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||percentage of participants|||Number
1311628|NCT02535364|Secondary|Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC|Best overall response (BOR) is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||percentage of participants|||Number
1311629|NCT02535364|Secondary|Percentage of Participants With CR or CRi, as Determined by an IRC|ORR is defined as the percentage of participants with CR or CRi based on IRC assessment (refer to criteria in Outcome Measure #1)|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one JCAR015 infusion, and who were evaluable for response (excludes 5 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion).|||percentage of participants||95% Confidence Interval|Number
1311630|NCT02535364|Primary|Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematopoietic Recovery (CRi), as Determined by an Independent Review Committee (IRC)|Overall remission rate (ORR) is defined as the percentage of participants with CR or CRi based on IRC assessment. For CR, all of the following must be met: (1) in bone marrow, trilineage hematopoiesis and < 5% blasts; (2) in peripheral blood, neutrophils > 1,000/µL, platelets > 100,000/µL, and circulating blasts < 1%; (3) no clinical evidence of extramedullary disease by physical examination and no symptoms suggestive of CNS involvement (if additional assessments such as CSF assessment by lumbar puncture or Ommaya reservoir tap, CNS imaging, or biopsy are performed, results must show no evidence of disease); (4) no platelet and/or neutrophil transfusions ≤ 7 days before the date of peripheral blood sampling, and (5) no clinical evidence of recurrence for 4 weeks. For CRi, all criteria for CR are met except that one or more of the following exists in the peripheral blood: neutrophils ≤ 1,000/µL, platelets ≤ 100,000/µL, or platelet transfusions ≤ 7 days before blood sampling.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one JCAR015 infusion, and who were evaluable for response (excludes 2 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion).|||percentage of participants||95% Confidence Interval|Number
1311631|NCT02535065|Primary|Number of Patients With Technical Success|Technical success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm|12 months||||Participants|||Count of Participants
1311632|NCT02535065|Primary|Number of Patients Without Major Adverse Events|Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation|30 days||||Participants|||Count of Participants
1311633|NCT02535026|Primary|Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Number of Tissue samples||Number
1311634|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
1311646|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
1311635|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
1311636|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
1311637|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
1311638|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
1311639|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
1311640|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
1311641|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
1311642|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
1311643|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
1311644|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
1311645|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
1314930|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN||96 weeks||||participants|participants||Number
1311647|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
1311648|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) less than (<) 40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) greater than or equal to (≥) 70 years.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
1311649|NCT02535026|Primary|Percentage of Participants With Histological Sub-types of Breast Cancer|Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
1311650|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were estrogen receptor (ER) + and/or progesterone receptor (PR) +, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Histological grading was done by Nottingham Histologic Score system based on three factors, a) the amount of gland formation (differentiation), b) the nuclear features (pleomorphism) and c) the mitotic activity. Each of these features is scored from 1-3, and then each score is added to give a final total score ranging from 3-9. The final total score is used to determine the grade in the following way: i) Grade 1 tumors have a score of 3-5, ii) Grade 2 tumors have a score of 6-7, and iii) Grade 3 tumors have a score of 8-9.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype could be identified.|||percentage of participants|Tissue samples||Number
1311651|NCT02535026|Primary|Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures|"HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure. The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it’s called “HER2 negative (-).” If the score is 2+, it's called borderline. A score of 3+ is called “HER2 positive.” Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status. Tissue samples with SISH test results + were considered as HER2+. Tissue samples for which HER2 status was not determined were considered as HER2 equivocal."|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
1311652|NCT02534935|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains||Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3)|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here, N signifies number of participants evaluable for this outcome measure.|||titers||95% Confidence Interval|Geometric Mean
1311653|NCT02534935|Secondary|Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains||Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3)|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311654|NCT02534935|Secondary|Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).|1 month (Mon) after Vaccination (Vac) 2|"Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure."|||percentage of Participants||95% Confidence Interval|Number
1311655|NCT02534935|Secondary|Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).|1 Month After Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311693|NCT02533531|Secondary|Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch|Successful performance of the 1-Lead Patch adhesive throughout the study period for each subject. Subject skin irritation will be assessed upon initial placement of the 1-Lead Patch by the clinical caregiver. Subjects will be asked to self-assess skin irritation and to report to the clinician at the end of the trail period. Data were not collected.|Between 7 and 14 days|Data were not collected.||||||
1311656|NCT02534935|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC)Throughout the Study|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From Vaccination 1 up to 6 months after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
1311657|NCT02534935|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From 1 month after Vaccination 3 up to 6 months after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here N signifies number of participants evaluable for this outcome measure."|||percentage of Participants||95% Confidence Interval|Number
1311658|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From the Vaccination 1 up to 1 month after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
1311659|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|within 30 Days after any Vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
1311660|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|within 30 Days after Vaccination 3|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311667|NCT02534935|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2|Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|within 7 Days after Vaccination 2|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311950|NCT02527161|Primary|Implant Location/Assessment of Alignment|Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.|3 months Post-Operatively|Participants with available data. Participants=knees.|||degrees||Standard Deviation|Mean
1311661|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|within 30 Days after Vaccination 2|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311662|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|within 30 Days after Vaccination 1|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
1311663|NCT02534935|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3|Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).|within 7 Days after Vaccination 3|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311664|NCT02534935|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2|Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).|within 7 Days after Vaccination 2|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311665|NCT02534935|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1|Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).|within 7 Days after Vaccination 1|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
1311666|NCT02534935|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3|Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|within 7 Days after Vaccination 3|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
1311692|NCT02533570|Primary|Number and Percentage of Subjects Having an Adverse Event (AE)|Any treatment-emergent adverse events (TEAEs), any drug-related TEAEs, any SAEs, treatment-related serious adverse events (SAE), deaths, adverse events (AEs) leading to study discontinuation, and number of patients experiencing Grade 1, 2, and 3 TEAEs.|Up to 127 days (9 weeks after final dose)||||Participants|||Count of Participants
1314931|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN||96 weeks||||participants|participants||Number
1311668|NCT02534935|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1|Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|within 7 Days after Vaccination 1|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1311669|NCT02534935|Primary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|1 month after Vaccination 3|All eligible participants randomized to study received,scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here,overall number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1311670|NCT02534883|Secondary|Resistance Score|"Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being normal."|At time of procedure.||||units on a scale||Standard Deviation|Mean
1311671|NCT02534883|Secondary|Number of Complications|Count of complications at time of surgery.|At time of procedure.||||complications||Standard Deviation|Mean
1311672|NCT02534883|Secondary|Maximum Dilator Size|The largest cervical dilator that could be passed through the internal cervical os.|At time of procedure.||||millimeters||Standard Deviation|Mean
1311673|NCT02534883|Secondary|Dilation Time in Minutes|Time from beginning of cervical dilation to completion of cervical dilation.|At time of procedure.||||minutes||Standard Deviation|Mean
1311674|NCT02534883|Secondary|Number of Recorded Side Effects.|Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects|At time of surgery/cervical dilation||||number of side effects out of seven|side effects|Standard Deviation|Mean
1311675|NCT02534883|Primary|Efficacy (Cervical Ripening)|To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.|At time of surgery/cervical dilation|Outcome measures presented below.|||minutes||Standard Deviation|Mean
1311676|NCT02534493|Secondary|Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline|The secondary efficacy variable is the decrease in Symptoms Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ) obtained 2 months after the 28-day CTMD treatment period compared to the Baseline SSS score.|2 months||||point decrease in SSS||Standard Deviation|Mean
1311677|NCT02534493|Primary|Change in SSS of the BCTQ at 28 Days vs Baseline|The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms).|28 days|Primary outcome measures were analyzed for unilateral and bilateral subjects combined, but measures were analyzed for unilateral and bilateral subjects separately as well.|||point decrease in SSS||Standard Deviation|Mean
1311678|NCT02534324|Secondary|Systolic Blood Pressure at Follow-up|Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.|3 to 7 days||||mmHg||Standard Deviation|Mean
1311679|NCT02534324|Secondary|Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department|Participants who had major hypertensive-related events defined by those who had one or more of the followings: acute chest pain, heart failure, acute coronary syndromes, acute aortic syndromes, retinal/vitreous hemorrhage, hypertensive retinopathy, seizure, acute cerebrovascular diseases, hypertensive encephalopathy, which occurred within 7 days after discharge from emergency department.|7 days||||participants|||Number
1311680|NCT02534324|Primary|Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department|Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.|7 days||||participants|||Number
1311681|NCT02534129|Primary|Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria|A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.|8 weeks|All patients were analyzed by blinded observor|||units on a scale||Full Range|Median
1311682|NCT02533999|Other Pre-specified|Glasgow Children's Benefit Inventory (GCBI)|A composite score of GCBI for each patient will be calculated by assigning the individual question responses a numerical value from -2 to +2, then adding these up, dividing by the number of questions (24), and multiplying by 50 to produce a result on a scale from -100 (maximum harm) to+ 100 (maximum benefit) .|At six-months post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||scores on a scale||Standard Error|Mean
1311683|NCT02533999|Secondary|Adverse Events (Emergent Visits for Medical Care)|To assess differences in adverse events (emergent visits for medical care) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.|from discharge to 14 days post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Participants|||Count of Participants
1312337|NCT02511587|Primary|Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine|GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination|1 month||||Geometric mean titers||95% Confidence Interval|Geometric Mean
1311684|NCT02533999|Secondary|Days to Resumption of Normal Activities|"To assess differences in other outcomes (time to resumption of normal activities) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Return to normal activity. Normal activity is defined as carrying out the same types and amounts of daily activity as before surgery, even if still associated with fatigue. Activity will be scored as 1, none; 2, very little; 3, mostly normal; 4, normal."|from discharge to 14 days post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Days||95% Confidence Interval|Median
1311685|NCT02533999|Secondary|Days to Resumption of Normal Diet|"To assess differences in other outcomes (time to resumption of normal diet) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Return to normal diet. Normal diet is defined as consumption of the types and amount of food such that another family member would not be able to recognize that the patient had undergone throat surgery. Dietary progression from liquid to soft and solid food will be also documented. Diet will be scored as 1, liquids and soft diet only; 2, some solids; 3, mostly solids; and 4, normal diet."|from discharge to 14 days post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Days||95% Confidence Interval|Median
1311686|NCT02533999|Secondary|Number of Participants Who Experienced Bleeding Between 24 Hours and 14 Days Post-operatively (Secondary Period)|"To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) between 24 hours and 14 days post-operatively (secondary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Post-operative bleeding will be scored as follows:~Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence.~Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention. Level III. All children who require a return to the operating department for control of postoperative bleeding."|between 24 hours and 14 days post-operatively (secondary period)|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Participants|||Count of Participants
1311687|NCT02533999|Secondary|Number of Participants Who Experienced Bleeding Intraoperatively and 24 Hours Post-surgery (Primary Period)|"To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) intraoperatively and 24 hours post-surgery (primary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Post-operative bleeding will be scored as follows:~Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence.~Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention.~Level III. All children who require a return to the operating department for control of postoperative bleeding."|intraoperatively and 24 hours post-surgery (primary period)|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Participants|||Count of Participants
1311688|NCT02533999|Primary|Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery|"To assess differences in pain control, assessed by validated pain scores and requirement for postoperative analgesia, during the 14-day post-operative period in children ages 3 to 18 years undergoing adenotonsillectomy with a clinical diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Assessment of subjective pain. The child will be asked by the parent to grade severity of pain daily using the Wong-Baker FACES pain rating scale in the morning before eating, drinking, or taking analgesics. The Wong-Baker FACES pain rating scale is a 0 to 10 numerical rating scale (0, 2, 4, 6, 8, 10) with faces indicating the level of pain from a happy face at a score of 0 to a crying face at a score of 10. The scale is recommended for children 3 years and older.~Type and frequency of pain medication will be recorded."|during the 14-day post-operative period|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Days||95% Confidence Interval|Median
1311689|NCT02533726|Secondary|Compliance With Patient Turning Procedures|Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.|Duration of ICU admission (average 1 week)|Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions)|||percentage of time||Standard Deviation|Mean
1311690|NCT02533726|Primary|Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers|"NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.~Stage 1: Non-blanchable erythema of intact skin~Stage 2: Partial-thickness skin loss with exposed dermis~Stage 3: Full-thickness skin loss~Stage 4: Full-thickness skin and tissue loss~Unstageable: Obscured full-thickness skin and tissue loss~Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration"|Duration of ICU admission (average 1 week)|Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions)|||Participants|||Count of Participants
1311691|NCT02533570|Secondary|Proportion of Subjects Achieving an SRI Response at Day 85|"Assessment for response was made using data only for the visit of interest (Day 85), without regard for changes at prior on-treatment visits.~SRI: SLE Responder Index; SLE: Systemic lupus erythematosus"|85 days||||Participants|||Count of Participants
1311694|NCT02533531|Primary|Composite Outcome Measure - 100% Successful ECG Acquisition|Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.|Between 7 and 14 days|Data were not collected.||||||
1311695|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Spirometry.|FEV1/FVC. For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|ΔFEV1/FVC calculated as ratio.|||ratio||95% Confidence Interval|Least Squares Mean
1311696|NCT02533505|Secondary|Change in Ve|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in minute ventilation (Ve). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|Units of measure: ΔVe: mL/min.|||mL/min||95% Confidence Interval|Least Squares Mean
1311697|NCT02533505|Secondary|Change in Vt|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in tidal volume (Vt). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|Units of measure: ΔVt: mL|||mL||95% Confidence Interval|Least Squares Mean
1311698|NCT02533505|Secondary|Change in Ti/Ttot|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in fractional inspiratory time (Ti/total cycle time [Ttot]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|ΔTi/Ttot is measured as a ratio.|||ratio||95% Confidence Interval|Least Squares Mean
1311699|NCT02533505|Secondary|Change in RR|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|ΔRR: breaths/min|||breaths/min||95% Confidence Interval|Least Squares Mean
1311700|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter SaO2|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||SaO2: %||95% Confidence Interval|Least Squares Mean
1311701|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter VCO2|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||ΔVCO2: mL/min||95% Confidence Interval|Least Squares Mean
1311702|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in the Modified Borg Scale for Dyspnea|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo). Modified Borg scale for dyspnea was self-administered at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21). The Borg scale is a 1-item instrument through which a subject reports dyspnea symptoms on a scale of 0-10 to quantify the intensity of dyspnea (where 10 is most intense).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||units on a scale||95% Confidence Interval|Least Squares Mean
1311703|NCT02533505|Secondary|Change in Vt/Ti|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in mean inspiratory flow (tidal volume [Vt]/inspiratory time [Ti]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|Units of measure: Vt/Ti: mL/sec|||mL/sec||95% Confidence Interval|Least Squares Mean
1311704|NCT02533505|Secondary|Change From Pre-dose (Visit 2)to Post-dose (Visit 5) Assessment in Spirometry.|Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and IC (using an slow vital capacity [SVC] maneuver; IC/total lung capacity [TLC] will be used as a measure of resting hyperinflation). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||FEV1: L; ΔFVC: L; ΔIC: L||95% Confidence Interval|Least Squares Mean
1311705|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter HR|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||ΔHR: beats/min||95% Confidence Interval|Least Squares Mean
1311706|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Pulse (Defined as VO2/Heart Rate [HR]; VO2 is Obtained Via a Metabolic Cart; Used as a Surrogate for Stroke Volume)|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||mL/min/beats/min||95% Confidence Interval|Least Squares Mean
1311707|NCT02533505|Primary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Consumption (VO2; Obtained Via a Metabolic Cart)|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) – LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||mL/min||95% Confidence Interval|Least Squares Mean
1311708|NCT02533466|Secondary|Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge|Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||scores on a scale||Standard Deviation|Mean
1311709|NCT02533466|Secondary|Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge|Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||scores on a scale||Standard Deviation|Mean
1311710|NCT02533466|Secondary|Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining pH|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population|||pH units||Standard Deviation|Mean
1311711|NCT02533466|Secondary|Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining pH|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population|||pH units||Standard Deviation|Mean
1311712|NCT02533466|Secondary|Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining calcium concentration|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||ppm||Standard Deviation|Mean
1311713|NCT02533466|Secondary|Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining calcium concentration|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||ppm||Standard Deviation|Mean
1311754|NCT02532998|Secondary|Terminal Half-life (t½λz) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h||Standard Deviation|Mean
1311714|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the “lock and key” structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the “lock and key” structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 7 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
1311715|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the “lock and key” structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the “lock and key” structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 4 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
1311716|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the “lock and key” structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the “lock and key” structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 2 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
1311717|NCT02533466|Primary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the “lock and key” structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the “lock and key” structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (“lock and key” structure and enamel “pits”) X - Not evaluable"|Baseline, 30 minutes post dietary acid challenge|The Per Protocol (PP) population was defined as those subjects in the ITT (intent to treat) population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
1311718|NCT02533401|Primary|Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)|Treatment response was monitored throughout the study and assessed using standardized criteria. CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values. Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR. The percentage of participants with each level of best overall response was calculated.|Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)|All Participants Enrolled.|||percentage of participants|||Number
1311719|NCT02533401|Primary|Overall Survival (OS)|Participants were followed for survival throughout the study. OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis|Up to 5 years (from Baseline until death)|All Participants Enrolled.|||months||95% Confidence Interval|Mean
1311720|NCT02533401|Primary|Percentage of Participants Who Died|Participants were followed for survival throughout the study. The percentage of participants who died of any cause during the study was calculated.|Up to 5 years (from Baseline until death)|All Participants Enrolled.|||percentage of participants|||Number
1311743|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed by Estimating the Fractional Sodium Excretion in Urine for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 by assessment of fractional sodium excretion in urine for each urine collection time interval.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 0 to 8 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||% value||Standard Deviation|Mean
1311721|NCT02533401|Primary|Progression-Free Survival (PFS)|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.|||months||95% Confidence Interval|Mean
1311722|NCT02533401|Primary|Percentage of Participants With Death or Disease Progression|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. The percentage of participants with death or documented disease progression at any time during the study was calculated.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.|||percentage of participants|||Number
1311723|NCT02533258|Secondary|Number of Participants Discontinued Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.|||partcicipants|||Number
1311724|NCT02533258|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs)|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.|||participants|||Number
1311725|NCT02533258|Secondary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.|||participants|||Number
1311726|NCT02533258|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-­serious events.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib.|||participants|||Number
1311727|NCT02533258|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as >=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||months||95% Confidence Interval|Median
1311728|NCT02533258|Secondary|Duration of Response|Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as >=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study. Here 'number of participants analyzed' signifies participants who achieved a confirmed CR or PR.|||months||95% Confidence Interval|Median
1311744|NCT02532998|Secondary|Number of Participants With Clinically Significant Safety Laboratory Tests Values.|Clinically significant safety laboratory test values included hematology, clinical chemistry, urinalysis and urine chemistry, including urine creatinine and uric acid measurements. Viral serology and urine drugs of abuse, alcohol and cotinine were assessed for eligibility. If deterioration in laboratory value was associated with clinical symptoms and/or signs, the symptom or sign were reported as an adverse event and the associated laboratory result was considered as additional information. Laboratory results were listed and summarized according to change from baseline and repeat/unscheduled measurements. Any out of range laboratory results were flagged in the individual listings.|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
1311729|NCT02533258|Secondary|Objective Response Rate (ORR)|ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than [<]10 millimeter [mm] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||percentage of participants|||Number
1311730|NCT02533258|Primary|Mean Daily Dose of Axitinib||From initiation of axitinib treatment up to the end of the study (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||milligram||Standard Deviation|Mean
1311731|NCT02533258|Primary|Duration of Axitinib Treatment||From initiation of axitinib treatment up to the end of the study (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||months||95% Confidence Interval|Median
1311732|NCT02533167|Other Pre-specified|Maternal Satisfaction-operating Room|maternal satisfaction with operating room atmosphere will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied|24 hours||||units on a scale||Standard Deviation|Mean
1311733|NCT02533167|Other Pre-specified|Maternal Satisfaction With Postoperative Pain Control|with pain control at 24 hours postoperative will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied|24 hours||||units on a scale||Standard Deviation|Mean
1311734|NCT02533167|Other Pre-specified|Maternal Satisfaction With Pain Control in the Operating Room|with pain control in the operating room will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied|24 hours||||units on a scale||Standard Deviation|Mean
1311735|NCT02533167|Other Pre-specified|Satisfaction|maternal satisfaction with anesthesia care will be evaluated on post delivery day 1 utilizing a 100mm sliding scale where VAS 0= not satisfied at all up to 100= extremely satisfied|up to 24 hours||||units on a scale||Standard Deviation|Mean
1311736|NCT02533167|Other Pre-specified|Morphine Usage|24 hour morphine equivalents required in the operating room up to the initial 24 hours after delivery for pain management|up to 24 hours||||mg of morphine||Standard Deviation|Mean
1311737|NCT02533167|Primary|Pain|maternal evoked pain is evaluated utilizing a 100 mm Sliding VAS scale with 0=no pain through 100=most severe pain ever|up to 24 hours||||units on a scale||Standard Deviation|Mean
1311738|NCT02532998|Secondary|Pharmacodynamics of AZD9977 by Assessment of Total Urine Volume Excreted Cumulatively and During Each of the Urine Collection Intervals|"Pharmacodynamics of AZD9977 by assessment of total urine volume excreted cumulatively and during each of the urine collection intervals.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone"|From 8 hours before dosing until 24 hours after dosing|The PD analysis set will consist of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who have no major protocol deviations thought to impact on the analysis of the PD data.|||mL||Standard Deviation|Mean
1311739|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Urine Production for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 assessed per urine production for each urine collection time interval.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 8 hours before dosing until 24 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||mL||Standard Deviation|Mean
1311740|NCT02532998|Secondary|Pharmacodynamics of AZD9977 by Assessment of Total Potassium Excreted Cumulatively and During Each of the Urine Collection Intervals|"Pharmacodynamics of AZD9977 by assessment of total potassium excreted cumulatively and during each of the urine collection intervals.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone in comparison to AZD9977 placebo."|From 0 to 24 hours after dosing|The PD analysis set will consist of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who have no major protocol deviations thought to impact on the analysis of the PD data.|||mmol||Standard Deviation|Mean
1311741|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Fractional Potassium Excretion in Urine for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 assessed per fractional potassium excretion in urine for each urine collection time interval.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone"|From 0 to 8 hours post dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||% value||Standard Deviation|Mean
1311742|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Total Sodium Excreted Cumulatively and During Each of the Urine Collection Intervals.|"Pharmacodynamics of AZD9977 by assessment of total sodium excreted cumulatively and during each of the urine collection intervals.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 0 to 24 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||mmol||Standard Deviation|Mean
1311788|NCT02532010|Secondary|Time to Complete Response|Time from entry on study until documentation of complete remission (CR)|From entry on study until complete remission, assessed throughout the study period up to 2 years||||months||Full Range|Median
1314932|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN||96 weeks||||participants|participants||Number
1311745|NCT02532998|Secondary|Number of Participants With Clinically Significant Physical Examination Values.|"Number of participants with clinically significant physical examination values.~The complete physical examinations included an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, mouth and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. The brief physical examinations included an assessment of the general appearance, skin, abdomen, cardiovascular and respiratory systems. The results of the physical examination were listed by body system for each subject. Body weight was listed by participant and time-point. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment were reported as an adverse event (AE)."|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
1311746|NCT02532998|Secondary|Number of Participants With Clinically Significant Electrocardiogram.|"Clinically significant electrocardiogram values were recorded for all participants in the study.~A 12-lead ECG was obtained after each subject had rested in the supine position for at least 10 minutes and was performed in accordance with the Schedule of Assessments of study protocol.~The investigator judged the overall interpretation as normal or abnormal. If abnormal, it would have been decided as to whether or not the abnormality was clinically significant and the reason for the abnormality would have been recorded. The investigator could add extra 12-lead resting ECG safety assessments if there were any abnormal findings of if the investigator considered it was necessary for any other safety reason. These assessments would have been entered as an unscheduled assessment."|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
1311747|NCT02532998|Secondary|Number of Participants With Clinically Significant Pulse Rate.|"Clinically significant pulse rate (if available) was recorded for all participants in the study.~The pulse was obtained after each subject had rested in the supine position for at least 5 minutes and was performed in accordance with the Schedule of Assessments of study protocol.~Abnormal findings in pulse rate, after 10 minutes resting in the supine position, was defined as following:~• Pulse < 45 or > 85 beats per minute (bpm)"|From screening to post-study visit, up to 10 weeks|The SAF included all subjects who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
1311748|NCT02532998|Secondary|Number of Participants With Clinically Significant Blood Pressure Values.|"Clinically significant blood pressure values (if available) were recorded for all participants.~The systolic blood pressure (mmHg) and diastolic BP (mmHg) was obtained after each subject had rested in the supine position for at least 5 minutes and was performed in accordance with the Schedule of Assessments of study protocol.~Abnormal findings in blood pressure after 10 minutes resting in the supine position was defined as following:~Systolic blood pressure (SBP) < 90 mmHg or ≥ 140 mmHg~Diastolic blood pressure (DBP) < 50 mmHg or ≥ 90 mmHg."|From screening to post-study visit, up to 10 weeks|The safety analysis set (SAF) included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
1311749|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Sodium/Potassium Ratio in Urine in AZD9977 Treatment With Placebo Versus Treatment With AZD9977.|"The sum over the urine collection intervals of the logarithm of the urinary sodium/potassium ratio from two hours to eight hours post-dose.~NOTE: Note: Data are presented as the sum of the difference between ln(Na+) and ln(K+) over the collected intervals 2-4, 4-6 and 6-8 hours."|From 2 hours post dose to 8 hours post dose|The pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set (SAF) with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||sodium/potassium ratio||Standard Deviation|Mean
1311750|NCT02532998|Secondary|Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1311751|NCT02532998|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to t Hours After Dosing (AUC(0-t)) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1311752|NCT02532998|Secondary|Observed Maximum Concentration (Cmax) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1311753|NCT02532998|Secondary|Time to Reach Maximum Concentration (Tmax) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h||Full Range|Median
1311789|NCT02532010|Secondary|Event-free Survival|Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause|Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause, assessed throughout the study period up to 2 years||||months||Full Range|Median
1311755|NCT02532998|Secondary|Apparent Clearance (CL/F) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1311756|NCT02532998|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/F) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||L||Geometric Coefficient of Variation|Geometric Mean
1311757|NCT02532998|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||L||Geometric Coefficient of Variation|Geometric Mean
1311758|NCT02532998|Secondary|Apparent Clearance (CL/F) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1311759|NCT02532998|Secondary|Terminal Half-life (t½λz) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h||Standard Deviation|Mean
1311760|NCT02532998|Secondary|Time to Reach Maximum Concentration (Tmax) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all subjects who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h||Full Range|Median
1311761|NCT02532998|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to t Hours After Dosing (AUC[0-t]) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311762|NCT02532998|Secondary|Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311763|NCT02532998|Secondary|Observed Maximum Concentration (Cmax) of AZD9977|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311764|NCT02532998|Primary|Pharmacodynamics of AZD9977 Assessed Per Sodium/Potassium Ratio in Urine in Eplerenone Treatment Versus a Combination Treatment of Eplerenone and AZD9977.|"The sum over the urine collection intervals of the logarithm of the urinary sodium/potassium ratio from two hours to eight hours post-dose.~NOTE: Data are presented as the sum of the difference between ln(Na+) and ln(K+) over the collected intervals 2-4, 4-6 and 6-8 hours."|From 2 hours post dose to 8 hours post dose|The pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set (SAF) with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||sodium/potassium ratio||Standard Deviation|Mean
1311765|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311766|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311767|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311768|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311769|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311770|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311771|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311772|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1311773|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use)."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||minutes||Inter-Quartile Range|Median
1311774|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use)."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||minutes||Inter-Quartile Range|Median
1311775|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use)."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||minutes||Inter-Quartile Range|Median
1311790|NCT02532010|Secondary|Relapse-free Survival|Time from complete remission documentation to either AML relapse or death from any cause.|From date of complete remission until either AML relapse or death from any cause, whichever came first, assessed throughout the study period up to 2 years||||months||Full Range|Median
1311776|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use)."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||minutes||Inter-Quartile Range|Median
1311777|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
1311778|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
1311779|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
1311780|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
1311781|NCT02532179|Secondary|Change in In-vitro Mouse Antigen Binding to B-cells|The plan was to analyze serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants to determine if treatment inhibits in-vitro mouse antigen binding to B-cells after 6-months of treatment with mouse SCIT, using the per protocol allergenic extract doses. However, the Sponsor cancelled pursuit of mouse immunotherapy within its program at this time due to assay development complexities and cost; thus, there are no analyses/results for this endpoint/outcome.|Baseline (Pre-Treatment) to Week 24|No analysis conducted: Sponsor's decision to not pursue assay development in this study.||||||
1311782|NCT02532179|Secondary|Change in Mouse-Specific IgG4 Antibodies|"Serum Immunoglobulin G4 (IgG4) is a subtype of antibody produced by the immune system. If a participant has bacterial or viral infections, the immune system will respond to that particular infection by producing IgG4 antibodies.~This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgG4 versus post-baseline mouse-specific serum IgG4. The numerator is the geometric mean post-baseline IgG4 and, the denominator is the baseline IgG4. A ratio of greater than 1 would indicate an increase in IgG4 antibodies throughout the course of the study."|Baseline (Pre-Treatment) to Week 24|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Least Squares Mean
1311783|NCT02532179|Secondary|Change in Mouse-Specific IgG Antibodies|"Serum Immunoglobulin G (IgG) is an antibody produced by the immune system. If a participant has bacterial or viral infections, the immune system will respond to that particular infection by producing IgG antibodies.~This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgG versus post-baseline mouse-specific serum IgG. The numerator is the geometric mean post-baseline IgG and, the denominator is the baseline IgG. A ratio of greater than 1 would indicate an increase in IgG throughout the course of the study."|Baseline (Pre-Treatment) to Week 24|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Least Squares Mean
1311784|NCT02532179|Secondary|Change in Mouse-Specific IgE Antibodies|"Serum Immunoglobulin E (IgE) is an antibody produced by the immune system. If a participant has an allergy, the immune system will respond to that particular allergen by producing IgE antibodies. These antibodies travel to cells that release chemicals, causing allergic reactions.~This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgE versus post-baseline mouse-specific serum IgE. The numerator is the geometric mean post-baseline IgE and the denominator is baseline IgE. A ratio of greater than 1 would indicate an increase in IgE throughout the course of the study."|Baseline (Pre-Treatment) through Week 24|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Least Squares Mean
1311785|NCT02532179|Primary|Number of Reported Serious Adverse Events (SAEs)|Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation.|Baseline (Pre-Treatment) through 24 Weeks of Treatment|Intent-to-treat|||Number of SAEs|||Number
1311786|NCT02532179|Primary|Number of Reported Adverse Events (AEs)|Frequency of any AEs tabulated by preferred event term.|Baseline (Pre-Treatment) through 24 Weeks of Treatment|Intent-to-treat|||Events|||Number
1311787|NCT02532010|Secondary|Remission Duration|Time from CR documentation to AML relapse|time from complete remission to AML relapse, assessed throughout the study period up to 2 years.||||months||Full Range|Median
1311791|NCT02532010|Secondary|Overall Remission Rate|Overall remission rate is defined as number of subjects with complete remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR) according to the IWG criteria. CRi is defined as All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL)), PR is defined as relevant in the setting of phase I and II clinical trials only; all hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pretreatment bone marrow blast percentage by at least 50 percent.|6 months||||Participants|||Count of Participants
1311792|NCT02532010|Secondary|Overall Survival|Survival following treatment to the date of death|2 years||||Participants|||Count of Participants
1311793|NCT02532010|Primary|Complete Remission Rate|Complete remission rate is defined as number of subjects with complete remission according to the IWG criteria, which is defined by presence of <5 percent of blasts in the bone marrow, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.|6 months||||Participants|||Count of Participants
1311794|NCT02531867|Primary|Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs)|Adverse events are any unwanted adverse medical occurrence in patients who are treated with a medicinal drug, whether or not considered drug-related. This includes events observed in patients administered with asfotase alfa between the first dose of asfotase alfa and the completion of patient’s last visit for the clinical study.|Events that occurred between the first dose of asfotase alfa and the completion of the patient's last visit, which was up to 5 months.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.The safety set comprised all patients who received at least 1 dose of the investigational drug.|||Participants|||Count of Participants
1311795|NCT02531698|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains||Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
1311796|NCT02531698|Secondary|Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains||Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
1311797|NCT02531698|Secondary|Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).|1 month after Vaccination 2 and 6 months after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
1311798|NCT02531698|Secondary|Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|1 month after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
1311799|NCT02531698|Primary|Number of Days Participant's Missed School Due to Adverse Event (AE) During the Vaccination Phase||From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Days||Standard Deviation|Mean
1311800|NCT02531698|Primary|Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 3|Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|Within 30 minutes after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311801|NCT02531698|Primary|Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 2|Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|Within 30 minutes after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311802|NCT02531698|Primary|Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 1|Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|Within 30 minutes after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
1311803|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311804|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311805|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 3|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311806|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311807|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 1|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
1311808|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From the Vaccination 1 up to 6 months after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants|||Number
1311809|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-up Phase|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From 1 month after Vaccination 3 up to 6 months after the Vaccination 3|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination.|||Percentage of participants|||Number
1311810|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants|||Number
1311811|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants|||Number
1311812|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 3|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after Vaccination 3|Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit.|||Percentage of participants|||Number
1311813|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 2|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after Vaccination 2|Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit.|||Percentage of participants|||Number
1311814|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 1|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants|||Number
1311815|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Throughout the Study|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|From the Vaccination 1 up to 6 months after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311816|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Follow-up Phase|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|From 1 month after Vaccination 3 up to 6 months after the Vaccination 3|"Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. Here N signifies number of participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311817|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Vaccination Phase|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311818|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Any Vaccination|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311819|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 3|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311820|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 2|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311821|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 1|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
1311822|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|From Vaccination 1 up to 6 months after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311823|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|From 1 month after Vaccination 3 up to 6 months after Vaccination 3|"Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. Here N signifies number of participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311824|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|From the Vaccination 1 up to 1 month after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311825|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1311826|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 3|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1312019|NCT02524418|Secondary|Number of Cholangioscopic Exams That Detected Ductal Stones|The abnormalities found during the procedure, such as ductal stones.|Day 1|There were a total of 78 Cholangioscopic examinations in the 70 subjects in this study; 35 exam found stones. Where as in the Pancreatoscopy arm 5 participants were evaluated with only 3 exams being evaluable..|||exams|total number of exams||Number
1311827|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311828|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1|SAE was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
1311829|NCT02531698|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).|Within 7 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311830|NCT02531698|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).|Within 7 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311831|NCT02531698|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).|Within 7 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
1311832|NCT02531698|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3|Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|Within 7 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311833|NCT02531698|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2|Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|Within 7 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here number of participants analyzed (N) signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1311834|NCT02531698|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|Within 7 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
1311835|NCT02531698|Primary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|1 month after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
1311836|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.|||units on a scale|images|Standard Error|Mean
1311837|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.|||units on a scale|images|Standard Error|Mean
1311838|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 month|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for DT Investigational - Scout & DT Volume.|||units on a scale|images|Standard Error|Mean
1311839|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 2 - PA and LAT Chest arm above.|||units on a scale|images|Standard Error|Mean
1311840|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 1 - PA Chest arm above.|||units on a scale|images|Standard Error|Mean
1311841|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months||||units on a scale|images|Standard Error|Mean
1311852|NCT02531373|Primary|Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 3 (Month 5)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
1311842|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months||||units on a scale|images|Standard Error|Mean
1311843|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months||||units on a scale|images|Standard Error|Mean
1311844|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|224 image ratings from 7 radiologist readers (32 images rated x 7 readers) for Predicate & Invest. DE - Human Subjects arm above.|||units on a scale|images|Standard Error|Mean
1311845|NCT02531373|Secondary|Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 4 (Month 11-15)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
1311846|NCT02531373|Secondary|Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|Before Vaccination 4 (Month 10-13)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
1311847|NCT02531373|Secondary|Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 4 (Month 11-15)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Percentage of participants||95% Confidence Interval|Number
1311848|NCT02531373|Secondary|Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|Before Vaccination 4 (Month 10-13)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Percentage of participants||95% Confidence Interval|Number
1311849|NCT02531373|Secondary|Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 3 (Month 5)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Percentage of participants||95% Confidence Interval|Number
1311850|NCT02531373|Secondary|Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.|Baseline and 1 month after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Ratio||95% Confidence Interval|Geometric Mean
1311851|NCT02531373|Secondary|Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
1311874|NCT02530281|Primary|Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data||Baseline - Week 4|Participant|||mg/5 min||Standard Deviation|Least Squares Mean
1311853|NCT02531373|Primary|Infants: Percentage of Participants With a Solicited Systemic Adverse Event|Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.|Up to 14 days after any vaccination|The analysis population included all randomized infant participants who received at least one dose of study vaccination and had follow-up for the outcome measure. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
1311854|NCT02531373|Primary|Infants: Percentage of Participants With a Solicited Injection-site Adverse Event|Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.|Up to 14 days after any vaccination|The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
1311855|NCT02531373|Primary|Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to time of Vaccination 4 (Month 10-13)|The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
1311856|NCT02531373|Primary|Infants: Percentage of Participants With an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 1 month after Vaccination 4 (Month 11-15)|The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
1311857|NCT02531373|Primary|Adults: Percentage of Participants With an Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 6 weeks after vaccination|The analysis population included all randomized adult participants who received study vaccination.|||Percentage of participants||95% Confidence Interval|Number
1311858|NCT02531308|Primary|Progression Free Survival|rate of progression in patients 2 years after diagonosis|2 year|Study terminated prematurely.||||||
1311859|NCT02530671|Secondary|Comparison of BSI Between Periods||0-3, 9-12 months||||percentage of the original bristle field||Standard Deviation|Mean
1311860|NCT02530671|Primary|Bristle Splay Index (BSI) After a Specific Time-of-use|A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).|3, 6, 9 and 12 months||||percentage of the original bristle field||Standard Deviation|Mean
1311861|NCT02530671|Secondary|Pocket Probing Depths at 12months||12 months||||mm||Standard Deviation|Mean
1311862|NCT02530671|Secondary|Percentage of Recession Sites Demonstrating a Change of ≥1mm||12 months||||percentage of sites|||Number
1311863|NCT02530671|Secondary|Recession at All Buccal Sites||12 months||||mm||Standard Deviation|Mean
1311864|NCT02530671|Primary|Gingival Recession at Sites With Preexisting Recessions ≥2mm||12 months||||mm||Standard Deviation|Mean
1311865|NCT02530450|Secondary|% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia||3 months and 6 months|||||||
1311866|NCT02530450|Primary|The Primary Outcome Measure Was Change in HgbA1c||0 months, 3 months and 6 months||||HbgA1c %||Inter-Quartile Range|Median
1311867|NCT02530294|Secondary|Proportion of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4||From Baseline to Week 4|Participant|||% of subjects|||Number
1311868|NCT02530294|Secondary|Proportion of Subjects Who Have a ≥2 Grade Improvement in HDSS From Baseline at Week 4||From Baseline to Week 4|Participant|||% of subjects|||Number
1311869|NCT02530294|Primary|Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4||From Baseline to Week 4|Participant|||mg/5 min||Inter-Quartile Range|Median
1311870|NCT02530294|Primary|Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4||Baseline - Week 4|Participant|||mg/5 min||Standard Deviation|Least Squares Mean
1311871|NCT02530294|Primary|Proportion of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4||From Baseline to Week 4|Participant|||% of subjects|||Number
1311872|NCT02530281|Secondary|Proportion of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4||From Baseline to Week 4|Participant|||% of subjects|||Number
1311873|NCT02530281|Secondary|Proportion of Subjects Who Have a ≥2 Grade Improvement in HDSS From Baseline at Week 4||From Baseline to Week 4|Participant|||% of subjects|||Number
1311878|NCT02530125|Other Pre-specified|PD-1 and PD-L1 Pathway Specific Expression Markers|Tissue sample slides from the diagnostic biopsy will be evaluated by immunohistochemistry for expression of PD-1 and PD-L1. Presence/absence (binary) of PD-1 and PD-L1 will be correlated with response to pidilizumab and clinical outcomes.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311879|NCT02530125|Other Pre-specified|Levels of Serum Biomarkers of Immune and Inflammatory Response|Peripheral blood will be tested for serum levels of TNF-α, IFN-γ, IL-2, IL- 7, IL-9, and galectin-1. Levels will be compared from specified time points through treatment.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311880|NCT02530125|Other Pre-specified|Change in Soluble PD-L1 Levels|Peripheral blood obtained at day 1 and day 127 will be analyzed and levels will be compared to evaluate for a change (increase/decrease) following treatment with pidilizumab.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311881|NCT02530125|Secondary|Time to Second Line Chemotherapy (TSLC)|To estimate time to second line chemotherapy (TSLC) at 2 years|Up to 2 years|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311882|NCT02530125|Secondary|Relapsed Disease||Up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311883|NCT02530125|Secondary|Progression Free Survival (PFS)|To estimate the progression free survival (PFS) at 2 years. PFS will be defined as time from study enrollment until the first occurrence of disease relapse, progression, re-initiation of cytotoxic chemotherapy, or death due to disease, or until last contact if the patient did not experience any of these.|Up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311884|NCT02530125|Secondary|Overall Survival (OS)|To estimate the overall survival (OS) at 2 years|From study enrollment until death, or until last contact, assessed up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311885|NCT02530125|Secondary|The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03.|"Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up to the point of termination of the study.|This is only based of of 4 patients that received treatment of pidilizumab. Study terminated early due to manufacturer decision to discontinue pidilizumab.|||Adverse events|||Number
1311886|NCT02530125|Primary|Response to Pidilizumab|Response will be defined as the proportion of CD4+CD25+PD-L1+ T lymphocytes and CD4+CD62L+CD127+ T lymphocytes responders. Responders are defined as either a) a 50% increase or b) a half standard deviation increase in lymphocyte subsets. Lymphocyte subsets will be evaluated by flow cytometry on peripheral blood obtained at specified time points through the treatment period.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
1311887|NCT02529995|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|Treatment discontinuation plus 28 days or 12 months after last subject first dose (LSFD). Results are based on data cut off of 2 Nov 2016.|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.|||% of participants||95% Confidence Interval|Number
1311888|NCT02529995|Primary|CL(ss)/F of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of apparent plasma clearance at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||L/h||Standard Deviation|Mean
1311889|NCT02529995|Primary|AUC(ss) of AZ7550 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1314933|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN||96 weeks||||participants|participants||Number
1311890|NCT02529995|Primary|AUC(ss) of AZ5104 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1311891|NCT02529995|Primary|AUC(ss) of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1311892|NCT02529995|Primary|C(ss, Max) of AZ7550 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311893|NCT02529995|Primary|C(ss, Max) of AZ5104 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311894|NCT02529995|Primary|C(ss, Max) of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311895|NCT02529995|Primary|CL/F of AZD9291 After Single Dosing|Rate and extent of absorption of single dose AZD9291 by assessment of apparent clearance following oral administration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||L/h||Standard Deviation|Mean
1311896|NCT02529995|Primary|AUC of AZ7550 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1311897|NCT02529995|Primary|AUC of AZ5104 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1311898|NCT02529995|Primary|AUC of AZD9291 After Single Dosing|Pharmacokinetics of AZD9291 after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1311899|NCT02529995|Primary|Cmax of AZ7550 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of maximum plasma concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311900|NCT02529995|Primary|Cmax of AZ5104 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of maximum plasma concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311901|NCT02529995|Primary|Cmax of AZD9291 After Single Dosing|Pharmacokinetics of AZD9291 after single dosing by assessment of maximum plasma AZD9291 concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1311902|NCT02529488|Primary|Mean Binocular Defocus Visual Acuity (VA)|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.|Day 20-40 and Day 120-180 from second eye implantation|This analysis population includes all eyes successfully implanted with the test article that had at least 1 postoperative visit, no previous surgery for correction of refractive errors, no preoperative ocular pathology or macular degeneration at any time, no pregnancy during the study, and no major protocol deviations (Best-Case Analysis Set).|||logMAR||Standard Deviation|Mean
1311903|NCT02528786|Primary|Number of Participants in Each Cluster|Clusters are described by an ellipse whose major and minor axes are the standard deviations in the x and y directions of the component points, which are rotated so that their covariance is equal to zero. The clusters were based upon the algorithms in which each data-point is assigned to one of four clusters: 1, 2, 3, or 4, representing no-target (negative controls [NTCs]), homozygotes one (XX), homozygotes two (YY), and heterozygotes (XY), respectively. Based on the calculated genetic composite scores from 8-single-nucleotide polymorphism (SNP)-based algorithm, participants were segregated into clusters.|Baseline|The analysis set included all participants who were enrolled and completed the study.|||participants|||Number
1311904|NCT02528721|Primary|Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy|Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."|||Percent overall agreement||95% Confidence Interval|Number
1311905|NCT02528721|Primary|Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy|Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."|||Percent negative agreement||95% Confidence Interval|Number
1311906|NCT02528721|Primary|Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy|Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."|||Percent positive agreement||95% Confidence Interval|Number
1311907|NCT02528500|Secondary|Absence of Type I and Type III Endoleaks at One Month Follow-up|Absence of Type I and Type III endoleaks|One Month followup|||||||
1311908|NCT02528500|Secondary|Patency (Primary, Assisted Primary, and Secondary)|Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.|Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment|||||||
1311909|NCT02528500|Secondary|Device Integrity, Including Individual Components of Device Integrity|Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components|Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment|||||||
1311910|NCT02528500|Secondary|Technical Success, Including Individual Components of Technical Success|Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure|Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment|||||||
1312082|NCT02519595|Secondary|Adverse Events|Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them|Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,||||participants|||Number
1311911|NCT02528500|Primary|Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL|Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL|Absence of procedural safety events through 30 days post procedure||||Participants|||Count of Participants
1311912|NCT02528331|Secondary|Percentage of Adverse Events||6 weeks||||percentage of adverse events|||Number
1311913|NCT02528331|Secondary|Partial Response Rate, as Measured by Y-BOCS|Partial response is defined as a reduction of greater than 25%.|6 weeks||||percentage of participants|||Number
1311914|NCT02528331|Secondary|Complete Response, as Measured by Y-BOCS|Complete response is defined as a reduction of Y-BOCS score greater than 35%.|6 weeks||||percentage of participants|||Number
1311915|NCT02528331|Primary|Remission Rate, as Measured by Y-BOCS|Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.|6 weeks||||percentage of participants|||Number
1311916|NCT02528305|Primary|Executive Function (Verbal Fluency Test)|"written verbal fluency test: participant asked to write down as many English words as possible within 60 seconds, starting with a particular letter of the alphabet, excluding proper nouns or plurals.~Baseline assessment-letter A Post Control assessment -letter S After HIT assessment -letter F"|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||words||Standard Deviation|Mean
1311917|NCT02528305|Primary|Long-term Memory Recall|"testing of verbal word presentation-delayed recall of 10 words 10 minutes after words initially presented (within 60 seconds).~Maximum= 10 words, minimum = no words"|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||words||Standard Deviation|Mean
1311918|NCT02528305|Primary|Ankle Brachial Pressure Index (ABPI)|ratio of blood pressure in left arm and right ankle|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||ABPI||Standard Deviation|Mean
1311919|NCT02528305|Primary|"Physical Function-Get up and go Test"|participant will be timed standing up from chair unaided,walking 30m, turning round and returning to a seated position on the chair, the average time of 3 attempts will be recorded.|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||seconds||Standard Deviation|Mean
1311920|NCT02528305|Primary|Estimated VO2 Max|VO2 max estimated via submaximal exercise test-submaximal treadmill walking test Calculated via formula: VO2max= 15.1+21.8 x speed (miles per hour) - 0.327 x heart rate (beats per minute) - 0.263 x speed x age (years) + 0.00504 x heart rate x age + 5.98 x gender (0=female, 1=male)|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||millilitres/kilogram/minute||Standard Deviation|Mean
1311921|NCT02528305|Primary|Short-term Memory Recall|testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||words||Standard Deviation|Mean
1311922|NCT02528305|Primary|General Well-being as Assessed by SF-36 Questionnaire|Assessment of: physical functioning, social functioning, mental health, pain, change in health, physical role limitation, mental role limitation, energy and vitality, health perception over preceding 4 weeks (other than change in health, which is a comparison to health the preceding year), expressed as a transformed score range 0-100, with a higher score indicating better function/freedom from pain etc|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||units on a scale||Standard Deviation|Mean
1311923|NCT02528305|Primary|Blood Pressure|taken with participant supine, measured on left arm|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||mmHg||Standard Deviation|Mean
1311924|NCT02528305|Primary|Body Fat Mass Estimated Via Bioimpedance|total body fat and trunk fat estimated via bioimpedance measured after overnight fast, expressed as percentage|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||percentage body fat||Standard Deviation|Mean
1311925|NCT02528305|Primary|FIB-4|"calculated from AST, ALT, platelets and participant's age and used to estimate amount of fibrosis in liver.~Fib-4 score of <1.45 has negative predictive value of 90% for advanced fibrosis."|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||Fibrosis Score||Standard Deviation|Mean
1311926|NCT02528305|Primary|AST: ALT Ratio|"ratio of liver enzymes aspartate aminotransferase (AST) to alanine aminotransferase (ALT).~used as a diagnostic aid e.g. AST:ALT of more than 2:1 is characteristic of alcoholic liver disease whereas fatty steatosis and many other causes of liver disease, ratio is less than or equal to 1.~Ratio may rise as fibrosis and cirrhosis develop in viral hepatitis."|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||ratio||Standard Deviation|Mean
1311927|NCT02528305|Primary|Oral Glucose Tolerance Test|measurement of capillary samples for glucose at time 0, followed by every 20 minutes for 2 hours following ingestion of 75g glucose. Results graphed against time, then area under the curve calculated for each of the 3 assessments.|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||mmol/L*min||Standard Deviation|Mean
1311928|NCT02528305|Primary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|calculation of insulin resistance via formula: fasting insulin (mIU/L) x fasting glucose (mg/dL)/405 normal insulin resistance -HOMA score <3 moderate insulin resistance -HOMA score 3-5 severe insulin resistance -HOMA score >5 Assessed at baseline, after 6 week control period and within 1 week of completing 6 weeks HIT|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||units on a scale||Standard Deviation|Mean
1311929|NCT02528097|Other Pre-specified|Administration of Albumin|The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)|Throughout Study (72 hours)|||||||
1311930|NCT02528097|Secondary|All Cause Mortality||At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.||||||
1311931|NCT02528097|Primary|Renal Failure|Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours|At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.||||||
1311932|NCT02527161|Secondary|Pain|Measured by Visual analogue scale (VAS)|5 years Post-Operatively|||||||
1312083|NCT02519595|Secondary|Additional Dose|Number of participants to whom additional doses of ketamine administered apart from the study dose|Patients will be assessed during procedure . Approximately 1 hours||||participants|||Number
1311933|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|2 years Post-Operatively|Participants with available data. Participants = knees. 87 knees had VAS pain during mobilization measurements and 86 knees had VAS pain at rest measurements.|||centimeters||Standard Deviation|Mean
1311934|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|12 months Post-Operatively|Participants with available data. Participants=knees.|||centimeters||Standard Deviation|Mean
1311935|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|6 months Post-Operatively|Participants with available data. Participants=knees.|||centimeters||Standard Deviation|Mean
1311936|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)||5 years Post-Operatively|||||||
1311937|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|2 years Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
1311938|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|12 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
1311939|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|6 months Post-Operatively|Participants with available data. Participants = knees.|||units on a scale||Standard Deviation|Mean
1311940|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)||5 years Post-Operatively|||||||
1311941|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|2 years Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
1311942|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|12 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
1311943|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|6 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
1311944|NCT02527161|Secondary|Revision Rate||5 years Post-Operatively|||||||
1311945|NCT02527161|Secondary|Mechanical Alignment|AnteroPosterior Long Leg X-rays: Alignment measured to mechanical axis at zero degrees.The mechanical axis is defined by lines joining the centre of the femoral head, centre of the knee joint and the centre of the ankle. A negative value = knee varus and a positive value = knee valgus.|12 months Post-Operatively|Participants with available data. Participants=knees.|||degrees||Full Range|Mean
1311946|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|5 years Post-Operatively|||||||
1311947|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|2 years Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
1311948|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|12 months Post-Operatively|Participants with available data. Participants=knees|||units on a scale||Standard Deviation|Mean
1311949|NCT02527161|Primary|Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|6 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
1314934|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN||96 weeks||||participants|participants||Number
1311951|NCT02527148|Secondary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated at 2 years and 5 years post-operatively. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|2 and 5 years|||||||
1311952|NCT02527148|Secondary|Perth CT Protocol|The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (–) value = varus.|3 months|Participants=knees|||degrees||Standard Deviation|Mean
1311953|NCT02527148|Secondary|The International Knee Society Score (IKSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively|||||||
1311954|NCT02527148|Secondary|The Forgotten Joint Score (FJS-12)|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|6-week, 6-month,12 month visits, 2 years and 5 years|||||||
1311955|NCT02527148|Secondary|Health-related Quality of Life (EQ-5D-3L)|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1= the value for full health.~The EQ VAS records the participant’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 =‘Best imaginable health state’ to 0= ‘Worst imaginable health state’."|Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years|||||||
1311956|NCT02527148|Secondary|The Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively|||||||
1311957|NCT02527148|Secondary|Knee Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively|||||||
1311958|NCT02527148|Secondary|Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L|A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores.|12 months|"Shapematch preoperative N=49, 12 month N=48.~Navigation preoperative N=50, 12 month N-49."|||QALY life year||Standard Deviation|Mean
1311959|NCT02527148|Secondary|Cost Effectiveness: Length of Stay in Hospital|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported..|14 days||||days||Standard Deviation|Mean
1311960|NCT02527148|Secondary|Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|Cost effectiveness data is not available.||||||
1311961|NCT02527148|Secondary|Cost Effectiveness: Wound Length|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.||||millimeters||Standard Deviation|Mean
1311962|NCT02527148|Secondary|Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)|Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.||||minutes||Standard Deviation|Mean
1311974|NCT02525536|Primary|Terminal Phase Elimination Half-life (T1/2) for AMG 386|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||hr||Standard Deviation|Mean
1311963|NCT02527148|Primary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months and 12 months. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|Preoperatively, 6-week, 6-months,and 12 months postoperatively|"Shapematch: 49 had preoperative and 6 month scores,48 had 6 week and 12 month scores.~Navigation: 50 had preoperative, and 6 month scores, 47 had 6 week, and 37 had 12 month scores~Participants=knees"|||units on a scale||Standard Deviation|Mean
1311964|NCT02526550|Secondary|Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™|Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.|Up to 28 days post booster vaccination||||percentage of participants|||Number
1311965|NCT02526550|Secondary|Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (Baseline) and Day 28 (post-vaccination)||||percentage of participants|||Number
1311966|NCT02526550|Primary|Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).|Day 0 (Baseline) and Day 28 (post-vaccination)|Per-protocol analysis|||titers||95% Confidence Interval|Geometric Mean
1311967|NCT02526524|Primary|Change in HbA1c (%) at 16 Weeks||Baseline and 16 weeks after the first dose of study medication|Modified Intent-to-Treat: Subjects who took ≥1 dose of randomized study medication and had ≥1 post-Baseline value for HbA1c collected ≤1 week after discontinuing study medication and prior to administration of any new anti-diabetic medication with timing and/or dosage that may have reasonably influenced any subsequent glycemic data collected.|||% glycated haemoglobin||Standard Error|Least Squares Mean
1311968|NCT02526290|Other Pre-specified|Device-related Adverse Events|Number of subjects who experienced any device-related adverse events.|6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.|||participants|||Number
1311969|NCT02526290|Secondary|Slit Lamp Biomicroscopy|Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.|6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.|||participants|||Number
1311970|NCT02526290|Secondary|Corrected Distance Visual Acuity|Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject’s own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).|Baseline and 6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.|||LogMAR||Standard Deviation|Mean
1311971|NCT02526290|Primary|Stimulated Acute Tear Production|Stimulated acute tear production in the study eye at Day 180 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm.|The stimulated and prestimulation (basal) measures were both performed at Day 180.|The Full Analysis Set (FAS) population included all subjects who received an investigational device and initiated neurostimulation.|||Scores on a scale||Standard Deviation|Mean
1311972|NCT02525536|Primary|Accumulation Ratio (AR) for AMG 386|Accumulation ratio (AR) was calculated by dividing the individual AUC (0-tau) value at Week 4 by the corresponding individual AUC (0-tau) value at Week 1.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose, Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||ratio||Standard Deviation|Mean
1311973|NCT02525536|Primary|Systemic Clearance at Steady State (CLss) for AMG 386|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Systemic clearance at steady state (CLss) was calculated as the ratio of dose administered to AUC (0 – tau), where AUC (0 – tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen). CLss was normalized to participant’s body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96 and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||milliliter/hour/kilogram(mL/hr/kg)||Standard Deviation|Mean
1314935|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN||96 weeks||||participants|participants||Number
1311975|NCT02525536|Primary|Vss: Volume of Distribution at Steady State for AMG 386|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state, estimated as: Vss = MRTinf *CLss, where MRTinf is mean residence time of drug extrapolated to infinity and CLss is the systemic clearance at the steady state. Vss was normalized to participant’s body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
1311976|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 4 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 4: 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||mcg/mL||Standard Deviation|Mean
1311977|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 1 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||mcg/mL||Standard Deviation|Mean
1311978|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 4 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||mcg*hr/mL||Standard Deviation|Mean
1311979|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 1 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
1311980|NCT02525536|Secondary|Number of Participant With Anti-AMG 386 Antibody|The immunogenicity of AMG 386 was evaluated with an immunoassay that detects anti-AMG 386 binding antibodies. Antibody formation reported at any of the time points was summarized.|Week 1: predose,1,2,6,24,48 and 98 hours after infusion end, Week 3: predose, Week 4: predose, 1,2,6,24,48,96,168 and 264 hours after infusion end, thereafter predose every 4 weeks starting from Week 8 up to 8 weeks after last dose (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
1311981|NCT02525536|Secondary|Percent Change From Baseline to Post-baseline in the Sum of the Longest Diameters of Tumor|The percent change from baseline to post-baseline is the largest percent reduction from baseline among all post-dose measures of the sum of the longest diameter of the tumor burden.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0 and valid post-baseline tumor lesion assessment available. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.|||percent change||Standard Deviation|Mean
1311982|NCT02525536|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of first administration of study treatment to the date of first documentation of PD or death caused by progression. For participants who did not have a documented PD or died owing to causes other than progression, TTP was censored at the time of last response assessment. PD is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG386.|||Days||Full Range|Median
1311983|NCT02525536|Secondary|Percentage of Participants With Objective Response|Objective response rate defined as the rate of participants with CR or PR based on RECIST 1.0 criteria. CR: disappearance of all target lesions, non-target lesions and normalization of tumor marker level. PR: at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.|||Percentage of participants||95% Confidence Interval|Number
1311984|NCT02525536|Secondary|Number of Participants With Best Overall Response|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above the normal limits. PD: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the full analysis set (FAS) with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.|||participants|||Number
1311985|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 4 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||hr||Full Range|Median
1311986|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 1 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||hour (hr)||Full Range|Median
1311987|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 4 Dose|Cmax is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||mcg/mL||Standard Deviation|Mean
1311988|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 1 Dose|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1311989|NCT02525536|Primary|Number of Participants With Abnormal Laboratory Values|The number of participants with any abnormal standard safety laboratory values collected throughout study. Parameters assessed were hematology, chemistry, coagulation and urinalysis. Abnormal laboratory values observed at any time point was summarized and reported.|Week 1: predose, 24, 48 and 96 hours after infusion end, Week 2 and 3: predose, Week 4: predose and 1 hour after infusion end, thereafter every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
1311990|NCT02525536|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, diastolic and systolic blood pressure, and pulse (beats per minutes). clinically significant change in vital signs observed at any time point was summarized and reported.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after infusion end, Week 2, 3, 4: predose and 1 hour after infusion end, thereafter predose of every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
1311991|NCT02525536|Primary|Number of Participants With Significant Change From Baseline in Electrocardiogram (ECG)|Change relative to baseline in electrocardiogram measured throughout study. Significant change in ECG observed at any time point was summarized and reported.|Week 1: predose, 1, 6 hours after end of infusion, Week 4: predose, 1 hour after end of infusion, Week 8, 16: predose, thereafter predose of every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
1311992|NCT02525536|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (AEs) and Serious Adverse Event (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
1311993|NCT02525536|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is defined as any treatment-related, grade 4 or higher hematologic or grade 3 or higher non-hematologic toxicity (according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0; hematologic toxicity means any toxicities which are categorized in blood/bone marrow category of CTCAE), except for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and infusion reaction, occurred during the first 28 days after the initial administration (before examination on Study Day 29). DLT also includes AST or ALT: >10*upper limit of normal (ULN) international units per liter (IU/L).|Day 1 up to Day 28|DLT analysis set: all participants who experience at least 1 DLT in the first 28 days of treatment, or who received all planned AMG 386 dose and are followed until the day before the treatment on Study Day 29.|||participants|||Number
1311994|NCT02525094|Secondary|Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies|A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study period.|Baseline (Day 1) to Week 22|ITT population included all participants who were randomized and received any study investigational product.|||Participants|||Count of Participants
1311995|NCT02525094|Secondary|Mean Trough Serum Concentration of MEDI9929|The mean serum concentrations of MEDI9929 was observed at specified timepoints.|Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)|PK population included all participants who received MEDI9929 and had a sufficient number of serum concentration measurements for computing PK parameters.|||mcg/mL||Standard Deviation|Mean
1312016|NCT02524418|Secondary|Number of Participants With Successful Removal of the Biliary or Pancreas Stones|The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.|Day 1|Spyglass-guided stone therapy was attempted in 26 patients with biliary stones|||participants|||Number
1311996|NCT02525094|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An Adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of investigational product, whether or not considered related to investigational product. Serious adverse event is any AE that resulted in:death;inpatient hospitalization or prolongation of existing hospitalization;persistent or significant disability or incapacity;is life-threatening;is a congenital anomaly/birth defect in offspring of a study participant;or was an important medical event that may not have resulted in death, threatened life,or required hospitalization and that, based on appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent one of outcomes above. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug until Week 22.|From treatment administration (Day1) to 22 weeks|"As-treated population included all participants who received any study drug. Participants who received at least one dose of MEDI9929 during study, regardless of randomized treatment assignment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group."|||Participants|||Count of Participants
1311997|NCT02525094|Secondary|Mean Change From Baseline in 5-D Pruritus Score at Week 12|The 5-D pruritus scale is a brief questionnaire designed to assess itch. This scale takes into account the multidimensional nature of pruritus, its impact on quality of life, and is capable of detecting change over time. The 5-D pruritus scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus). The higher values indicating more severe pruritus.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
1311998|NCT02525094|Secondary|Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12|Pruritus is assessed using an Numeric Rating Scale (NRS) (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
1311999|NCT02525094|Secondary|Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75|The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 75 responder is defined as a participant who achieves at least a 75% reduction in SCORAD score from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
1312000|NCT02525094|Secondary|Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50|The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 50 responder defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
1312001|NCT02525094|Secondary|Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12|The scoring of atopic dermatitis (SCORAD) is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
1312002|NCT02525094|Secondary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline|The investigator’s global assessment (IGA) allows investigators to assess overall disease severity at one given time point and consists of a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
1312003|NCT02525094|Secondary|Mean Change From Baseline in EASI Total Score at Week 12|The EASI evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
1312004|NCT02525094|Secondary|Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12|The EASI evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI75 responder defined as a participant who achieves at least a 75% reduction in EASI score from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
1312017|NCT02524418|Secondary|Spybite Sampling Attempts Per Procedure|The mean number of attempts per procedure|Day 1|Of the 70 Cholangioscopy participants in the study only 44 participants had non-stone lithotripsy-related indications. Spyglass sampling was attempted in 36 procedures.|||sampling attempts per procedure|Number of procedures analyzed|Full Range|Mean
1312005|NCT02525094|Primary|Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12|The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.|Baseline (Day 1) and Week 12|Intent-To-Treat (ITT) population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
1312006|NCT02524665|Secondary|Percentage of Participant Who Improved by at Least One Grade on the ISGA|During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Up to Week 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1312007|NCT02524665|Secondary|Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.|Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1312008|NCT02524665|Secondary|Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.|Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1312009|NCT02524665|Secondary|Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8|During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1312010|NCT02524665|Secondary|Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.|During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4|ITT analysis set. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Percent change||Standard Deviation|Mean
1312011|NCT02524665|Primary|Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.|During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Baseline and Week 8|Intent-to-treat (ITT) analysis set was used which included data from all randomized participants who received study product. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Percent change||Standard Deviation|Mean
1312012|NCT02524561|Secondary|Abnormal Mammogram/Biopsy|Abnormal mammogram requiring additional imaging modality such as MRI or ultrasound, or a breast biopsy. Information obtained from mammography reports.|baseline to 3 years|Women with mammography reports|||Participants|||Count of Participants
1312013|NCT02524561|Primary|BIRADS Breast Density|Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Latest (Year 3 of 4)|Women with mammograms 3-4 years after randomization|||participants|||Number
1312014|NCT02524561|Primary|BIRADS Breast Density|Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Year 1|Women with mammograms 1 year after randomization|||participants|||Number
1312015|NCT02524561|Primary|BIRADS Breast Density|Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Baseline (Prior to Randomization)|Women with mammograms are included.|||participants|||Number
1312020|NCT02524418|Secondary|Measurement in Minutes for Spyglass DS Therapeutic Maneuvers|The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.|approximately 2 hours|For the 75 participants in the study, 83 procedures were completed. Of the 83 procedures, sampling was attempted on 37 procedures in 27 participants.|||minutes|Number of Procedures analyzed|Full Range|Mean
1312021|NCT02524418|Secondary|Measurement in Minutes for Spyglass DS Diagnostic Maneuvers|The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.|approximately 2 hours|83 Spyglass procedures were performed on the 75 participants|||minutes|number of Spyglass Proceudres|Full Range|Mean
1312022|NCT02524418|Secondary|Measurement of Total Procedure Time Using the Spyglass DS|Time in minutes will be calculated for completing the procedure with the Spyglass DS.|approximately 2 hours|83 Spyglass procedures were conducted on the 75 participants|||minutes|number of Spyglass procedures|Full Range|Mean
1312023|NCT02524418|Secondary|Time to Set-up the Spyglass DS for the Procedure|The time it takes to set up the Spyglass DS and related equipment for the procedure.|approximately 2 hours|In 20 procedures, the Spyglass equipment set up was done after ERCP started and this time was recorded. The Investigators did not record the set up time for the other procedures.|||minutes||Full Range|Mean
1312024|NCT02524418|Primary|Number of Participants With Procedure Technical Success|The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.|Day 1|Five of the subjects had both Cholangioscopy and Pancreatoscopy. The results of these procedures were recorded and analyzed separately|||participants|||Number
1312025|NCT02524288|Primary|Number of Participants Who Discontinued Treatment Due to a Drug-related AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
1312026|NCT02524288|Primary|Number of Participants With One or More Drug-related AEs|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
1312027|NCT02524288|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
1312028|NCT02524288|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
1312029|NCT02524288|Primary|Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)|The Pearl Index is the number of in-treatment pregnancies with a conception date in any of the in-treatment cycles, divided by all treatment cycles in each participant from the first treatment cycle to the last treatment cycle (due either to discontinuation or completion), regardless of whether a treatment cycle was “at risk” or not. One woman-year is defined as 13 treatment cycles x 28 days. These efficacy results should be interpreted with caution. Due to the discontinuation of product development and early trial termination, the number of “at risk” treatment cycles in the denominator is based on uncleaned diary data.|Up to 1 year (13 28-day cycles)|All participants assigned to treatment who inserted at least 1 ENG-E2 ring, and who had at least 1 “at risk” treatment cycle, or participants with a treatment cycle (at risk or not) in which a pregnancy had occurred (i.e., treatment cycle containing an estimated conception date for a pregnancy).|||Pregnancies per 100 woman years|||Number
1312030|NCT02524158|Secondary|Lower Spine Stabilization - Core Strength|Time in seconds holding plank position on the elbows.|baseline to 12 weeks||||change in time in seconds||Standard Error|Mean
1312031|NCT02524158|Secondary|Lower Limb Strength and Balance - Eyes Open|The Single Leg Stance (SLS) is a commonly used measure of both lower leg strength and balance. A total of four trials were conducted - left and right leg with both eyes open and eyes closed. Each trial will be timed from the moment the participant lifts one foot off the floor until the moment they need to place it on the floor again. If the participant is able to stand on one leg for 60 seconds the trial will be stopped and they will be asked to switch side. Values range from 0 - 60 seconds with greater values indicating better balance.|baseline to 12 weeks||||change in seconds||Standard Error|Mean
1312032|NCT02524158|Secondary|Grip Strength|Grip strength in both hands of each participant will be measured using an adjustable, hydraulic grip strength dynamometer (Jamar Hydraulic Hand Dynamometer). Three trials will be conducted for each hand. In cases of current pain flare-ups or recent procedures to a hand or wrist, the affected hand is not tested, and the result of the one other hand is used. If both hands are used the best performance of two trials will be selected for each side, and the average of the left and right hand will be used for analysis. The value measured is pounds of force exerted and typically ranges from 0 - 150 lbs, with higher numbers indicating greater grip strength.|baseline to 12 weeks||||change in pounds per sq inch||Standard Error|Mean
1312033|NCT02524158|Secondary|Range of Motion - Flexion|Spinal Range of Motion (ROM) will be measured using a Saunders Digital Inclinometer, a portable device which isolates lumbar ROM. The device is placed along the spine and uses a precise optical angular scanner. Forward bend angle measures how far forward and downward a person can bend at the waist, from a fully erect and/or normal standing position. The value typically ranges from 0-180 degrees, with higher values indicating greater flexibility.|baseline to 12 weeks|Only a subset agreed to assessment. Some declined if concerned about injury.|||change in degrees||Standard Error|Mean
1312034|NCT02524158|Secondary|Attendance/ Home Practice|Two indicators of the amount of yoga practiced by each participant will be used. Actual attendance of yoga sessions will be assessed using VA medical record data. Attendance can range from 0-24 sessions attended for those participants randomized to yoga. Self-reported practice of yoga at home will be assessed using a weekly participant yoga log. The self-report yoga log assesses whether they practiced yoga each day, the amount of minutes practiced, the use of instructions, the difficulty of poses, and the estimated level of physical activity or exertion.|total # of sessions attended at end of 12 week intervention||||sessions attended||Standard Error|Mean
1312035|NCT02524158|Secondary|Self-efficacy for Managing Low Back Pain|Self-efficacy for controlling CLBP reflects levels of confidence in the ability to influence the intensity of back pain symptoms and the impact that CLBP has on daily life. The questions are based on self-efficacy items developed for the Medical Outcomes Study in mixed chronic diseases. The wording of the items has been adapted to be specific to CLBP. The measure consists of 6 items, rated on a 6-point Likert scale, with each item ranging from 0-10. The total score is the mean of the 6 items with higher scores indicating greater self-efficacy for managing CLBP.|baseline to 12 weeks||||change in units on a scale||Standard Error|Mean
1312036|NCT02524158|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a validated measure of sleep quality. The global PSQI score has a range of 0-21, with higher scores indicating worse sleep quality.|baseline to 12 weeks||||change units on a scale||Standard Error|Mean
1312037|NCT02524158|Secondary|Brief Anxiety Inventory (BAI)|The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms, particularly those that distinguish anxiety from depression. The BAI consists of 21 items, is self-administered and can be completed in 5 to 10 minutes. Items are scored on a scale of 0 to 3 and are summed to generate a total score. Scores range from 0 to 63, and higher scores indicate greater depression.|baseline to 12 weeks||||change in units on a scale||Standard Error|Mean
1312038|NCT02524158|Secondary|Center for Epidemiologic Studies Short Depression Scale (CES-D 10)|Depression will be assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Derived from the full CES-D, there are 10 items that ask about the frequency of mood symptoms, rated on a 4-point Likert scale ranging from 0 (Never) to 3 (All of the Time). Scores range from 0 to 30, and higher scores indicate greater depression. A number of items are reverse-scored and a score of 10 or greater is considered depressed. Normative data on people with assorted chronic illnesses are available for comparisons.|baseline to 12 weeks||||change in units on a scale||Standard Error|Mean
1312039|NCT02524158|Secondary|EuroQOL 5D (EQ5D)|The EQ5D is a preference-based measure of health-related quality of life. The measure produces a single score ranging from 0 (death) to 1.00 (optimal health). Scores can be integrated with time to calculate Quality Adjusted Life Years.|baseline to 12 weeks||||change in units on a scale||95% Confidence Interval|Mean
1312040|NCT02524158|Secondary|SF12 MCS|Mental Component Scale - Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.|baseline to 12 weeks||||change in units on a scale||Standard Error|Mean
1312041|NCT02524158|Secondary|SF12 PCS|Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.|baseline to 12 weeks||||change in units on a scale||Standard Error|Mean
1312042|NCT02524158|Secondary|Fatigue Severity Scale (FSS)|Fatigue (absence of energy) will be measured with the Fatigue Severity Scale (FSS). The FSS is a self-administered instrument developed to assess the impact and severity of fatigue. It consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63 or an average score ranging from 1.0-7.0. Higher scores reflect greater fatigue severity and less energy.|baseline to 12 weeks||||change in units on a scale||Standard Error|Mean
1312338|NCT02511431|Primary|Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment|The number of participants who experienced a > 2 log IU/mL decline in serum HDV RNA levels at 24 weeks of treatment|24 weeks||||Participants|||Count of Participants
1312043|NCT02524158|Secondary|Pain Interference - Brief Pain Inventory|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 7 interference items used a as a measure of pain interference. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 12 weeks||||change in units on a scale||Standard Error|Mean
1312044|NCT02524158|Secondary|Pain Intensity - Brief Pain Inventory|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 6 months|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
1312045|NCT02524158|Secondary|Pain Intensity - Brief Pain Inventory|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 12 weeks|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
1312046|NCT02524158|Primary|Roland-Morris Disability Questionnaire|The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.|baseline to 6-months|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
1312047|NCT02524158|Primary|Roland-Morris Disability Questionnaire|The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.|baseline to 12 weeks|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
1312048|NCT02524054|Secondary|Urine Output - mL|"Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed in the blood, diuresis is an expected 'side effect' of this treatment.~Following intervention, study team will measure urine output (mL). Study team will then rehydrate subject with an equal amount of liquid to their output."|Summation of total urine output (mL) at 1 hour following drug administration.|The 17 participants in 'Aerosol furosemide Study 2b' and 'Aerosol saline Study 2b' are the results from the same 17 subjects on two different test days.|||ml of urine||Standard Deviation|Mean
1312049|NCT02524054|Primary|Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.|"Subjects will rate breathing discomfort (dyspnea) during a 15 min exercise test using a visual analog scale before and after drug (or placebo) intervention. The treatment effect was measured as the rating of breathing discomfort rating before treatment minus the rating of breathing discomfort after treatment at equivalent work intensities.~Outcome Measure Time Frame: subjects performed arm exercise to induce dyspnea for approximately 15 min before and after aerosol inhalation. the average number of minutes between end of drug administration and post-intervention breathing discomfort rating:~Aerosol furosemide Study 2a arm: 38.7 minutes; Aerosol furosemide Study 2b arm: 21.8 minutes; Aerosol saline Study 2b arm: 21.3 minutes"|15 min||||units on a scale||Standard Deviation|Mean
1312050|NCT02523586|Primary|Oxygen Concentration Measured at the Oropharyngeal Location by Nasal Catheter|After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).|The subjects will each participate on one study day and will require 1 hour per subject.||||percentage of oxygen||95% Confidence Interval|Mean
1314936|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN||96 weeks||||participants|participants||Number
1312051|NCT02523586|Primary|Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor|After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).|The subjects will each participate on one study day and will require 1 hour per subject.|FiO2 at the lips|||percentage of oxygen||95% Confidence Interval|Mean
1312052|NCT02522624|Secondary|Intended Choice Metal Level|Participants indicated the plan they would choose that day. We categorized plans by governmental classifications of metal level (catastrophic, bronze, silver, gold).|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|Intended plan choice metal level data were not available for 2 participants in SMHP (Show Me My Health Plans decision aid) condition (n=162) and for 11 participants in healthcare.gov (Control) condition (n=152)|||participants|||Number
1312053|NCT02522624|Secondary|Improvements in HILM 2 (Health Insurance Literacy Measure)|Assessed confidence understanding terms.Improvement in HILM was defined as moving from “not confident” pre-intervention to “a little confident” or “very confident” post-intervention, or from “a little confident” pre-intervention to “very confident” post-intervention.|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)|||participants|||Number
1312054|NCT02522624|Secondary|Improvements in HILM 1 (Health Insurance Literacy Measure)|Assessed confidence estimating costs of care.Improvement in HILM was defined as moving from “not confident” pre-intervention to “a little confident” or “very confident” post-intervention, or from “a little confident” pre-intervention to “very confident” post-intervention.|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)|||participants|||Number
1312055|NCT02522624|Primary|Confidence in Choice|The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) decisional conflict scale assessed confidence in plan choice. Each item could be answered dichotomously (1=yes; 0=no). Responses were summed and a group average was obtained. Higher SURE values indicate more confidence in choice. The scale ranged from 0-4.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.||||units on a scale||Standard Deviation|Mean
1312056|NCT02522624|Primary|Decision Self-efficacy|The decision self-efficacy (DSE) scale measured participants' perceived ability to understand insurance info and resist unwanted decision pressure. The 6 items on the DSE scale were each rated on a 3-point scale (0=Not confident; 2=A little confident; 4=Very confident). The sum of the DSE items was divided by 6 and multiplied by 25 to obtain a score on a 0-100 scale. Higher values indicate more confidence in one’s decision-making ability.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.||||units on a scale||Standard Deviation|Mean
1312057|NCT02522624|Primary|Knowledge Score (% Correct)|8 questions developed in researchers' past work. Assessed health insurance knowledge.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.||||percentage of 8 items correctly answered||Standard Deviation|Mean
1312058|NCT02522286|Secondary|Option 5 Shared Decision Making Score|"Researchers measured the shared decision making process that occurs between patients and physicians during the appointment using a method called OPTION5. Researchers listened to audio-recorded patient appointments, identified any topic, defined as a health issue where alternate treatment or management option exist/where the need for a decision exists, and then measured each topic for each of the OPTION5 items on a scale of 0 (no effort: nothing observed or heard) to 20 (exemplary effort: excellent, careful attention to communication around the ideas and issues, with checks on understanding, for each of the 5 items described below. The total score is a sum of the scores from each of the 5 items at the clinic.~Item 1: presenting options Item 2: establishing a partnership with the patient Item 3: describing pros and cons of options Item 4: eliciting patient preferences Item 5: integrating patient preferences into the decision"|Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits)|From the 75 patients at each of the 4 clinics, 10 appointments were randomly selected to be audio-recordinged. The Number of Participants Analyzed reflects the number of topics identified from the 10 recordings at each clinic.|||scores on a scale||Standard Deviation|Mean
1312059|NCT02522286|Primary|Patients' Feeling of Respect by Their Doctor|"Patient responses to one statement modified from Consumer Assessment of Healthcare Providers and Systems (CAHPS) regarding the respect they felt from their doctor. Patients rated the statement My doctor showed respect for what I had to say, on a scale of 1 (definitely disagree) to 4 (definitely agree). The outcome measure was the percentage of patients that gave the top score of 4 on this statement."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
1312060|NCT02522286|Primary|Patient Responses to Stakeholder Generated Questions|"Patient responses to statements that were generated by the study's patient and physicians stakeholders regarding how they felt during their appointment. Patients rated 5 statements, described below, on a scale of 0 (definitely disagree) to 9 (definitely agree). The outcome measure is the percent of patients that responded with a top score of 9. Statement 1: My doctor and I accomplished my most important goals today. Statement 2: I feel cared for. Statement 3: I feel comfortable being open with my doctor. Statement 4: I felt my doctor was open with me. Statement 5: I know what my next steps are."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
1312061|NCT02522286|Primary|Doctor Facilitation Subscale of the Perceived Involvement in Care Scale|"Responses from this patient reported measure regarding their attitudes of doctor facilitation of patient involvement for their illness management. Patients rated 5 statements on a scale of 0 (definitely disagree) to 9 (definitely agree). The statements are as follows: 1) My doctor encouraged me to talk about personal concerns related to my medical symptoms, 2) My doctor asked me what I believe is causing my medical symptoms, 3) My doctor gave me a complete explanation for my medical symptoms or treatment, 4) My doctor encouraged me to give my opinion about my medical treatment, 5) My doctor asked me whether I agree with his/her decisions. The outcome measure was the percent of patients who gave the top score of 9 on all five statements."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
1312062|NCT02522286|Primary|Patient Rating of Shared Decision Making|"Responses from CollaboRATE, a 3-question validated patient reported measure of shared decision making. Patients answered questions on a scale of 0 (definitely disagree) to 9 (definitely agree). The CollaboRATE questions are as follows: 1) How much effort was made to help you understand your health issues? 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next? The outcome measure was the percent of patients who gave the top score of 9 on all three questions."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
1312063|NCT02520726|Secondary|Beck Scale for Suicide Ideation||1 month|All subjects lost to follow-up||||||
1312064|NCT02520726|Primary|Clinician-Administered PTSD Scale||Month|All subjects lost to follow-up||||||
1312065|NCT02520414|Primary|Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.|Absence of device related adverse events, or death.|2 weeks||||percentage of participants|||Number
1312066|NCT02520089|Secondary|Quick Disability of Arm, Shoulder and Hand|It is designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Where the better evaluation is equal to 0, and the worst evaluation is equal to 100.|9th months||||units on a scale||Standard Deviation|Mean
1312067|NCT02520089|Primary|Stans Scale|"The evaluation of the radiographic extent of the bony callus (consolidation grade) will be assessed via anteroposterior and lateral radiograph of the arm and classified in different levels, as follows:~Grade 0, no identifiable bony callus .~Grade 1, primary bony callus formation with little or no new periosteal bone.~Grade 2, new periosteal bone formation on two sides of the humerus.~Grade 3, new periosteal bone formation on three or four sides of the humerus."|9th month||||units on a scale||Standard Deviation|Mean
1312068|NCT02519855|Primary|Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody|Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
1312069|NCT02519855|Primary|Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody|Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
1312070|NCT02519855|Primary|Geometric Mean Titers of H3N2-specific Influenza Virus Antibody|Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
1312071|NCT02519855|Primary|Geometric Mean Titers of H1N1-specific Influenza Virus Antibody|Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
1312072|NCT02519855|Primary|Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Ratio of titers (Week 4 / Baseline)||95% Confidence Interval|Geometric Mean
1312073|NCT02519855|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1312084|NCT02519595|Secondary|Sedation Duration|Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution.|Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours||||Minutes||Inter-Quartile Range|Median
1312489|NCT02505334|Secondary|Change in Body Mass Index (BMI)|Change from baseline (week 0) in BMI was evaluated after 26 weeks of treatment.|Week 0, Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||Kilogram (kg)/meter (m)^2||Standard Deviation|Mean
1312074|NCT02519842|Secondary|Percentage of Participants Who Experienced No Vomiting, Regardless of Rescue Medication Use, During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1|Vomiting was assessed, regardless of rescue medicine use, following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. Rescue medication was permitted to alleviate symptoms of established nausea or vomiting; but not as preventive medication. The percentage of participants with no vomiting and no retching episodes in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy in Cycle 1, was calculated.|0 to 120 hours post initiation of chemotherapy (up to 15 days after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
1312075|NCT02519842|Secondary|Percentage of Participants Who Experienced a Complete Response During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1|Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy in Cycle 1, was calculated.|0 to 120 hours post initiation of chemotherapy (up to 15 days after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
1312076|NCT02519842|Secondary|Percentage of Participants Who Experienced a Complete Response During the Acute Phase (0 to 24 Hours Post Initiation of Chemotherapy) in Cycle 1|Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the acute phase, defined as the time period of 0 to 24 hours post initiation of chemotherapy in Cycle 1, was calculated.|0 to 24 hours post initiation of chemotherapy (up to 1 day after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
1312077|NCT02519842|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A statistical analysis was performed to compare the percentage of participants who discontinued in Cycle 1 due to an AE and received fosaprepitant regimen compared with the percentage of participants who received control regimen.|Up to 6 months (up to last dose of study drug)|All participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1312078|NCT02519842|Primary|Percentage of Participants Who Experienced One or More Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A statistical analysis was performed for Tier 2 AEs in Cycle 1 to compare the percentage of participants who received fosaprepitant regimen and experienced at least 1 Tier 2 AE compared with the percentage of participants in the control regimen. The Tier 2 endpoint included broad clinical and laboratory AE categories consisting of the percentage of participants with any AE, drug-related AE, serious AE, and AEs that are both drug-related and serious. Tier 2 AEs were not pre-specified as events of interest and inclusion in the Tier 2 analysis required that at least 4 participants in any treatment group exhibited the AE.|Up to 6.5 months (up to 2 weeks after last dose of study drug)|All participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1312079|NCT02519842|Primary|Percentage of Participants Who Experienced a Complete Response During the Delayed Phase (>24 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1|Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the delayed phase, defined as the time period of >24 to120 hours post initiation of chemotherapy in Cycle 1, was calculated.|>24 to 120 hours post initiation of chemotherapy (1 to 15 days after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
1312080|NCT02519712|Primary|Complete Remission (CR)|"Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected.~Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain < 5% blasts. Auer rods should not be detected.~Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present."|4 weeks|Data were not collected||||||
1312081|NCT02519595|Secondary|Sedation Satisfaction|Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3|At the end of the procedure. Approximately 1 hour|consultant satisfaction missing in 6 participants|||participants|||Number
1312114|NCT02517021|Secondary|Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
1312085|NCT02519595|Primary|Pain|"Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, No hurt to a crying face at 10 Hurts worst. The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4)."|Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes||||units on a scale||Inter-Quartile Range|Median
1312086|NCT02519595|Primary|Sedation Efficacy|Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.|Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours||||units on a scale||Inter-Quartile Range|Median
1312087|NCT02519387|Secondary|Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events||3 months|This is the intent-to-treat population.|||participants|||Number
1312088|NCT02519387|Secondary|Physicians’ and Patients’ Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|3 months||||units on a scale||Standard Deviation|Mean
1312089|NCT02519387|Secondary|Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage|Patients will record any other pain medication used in a patient home diary|3 months||||participants|||Number
1312090|NCT02519387|Secondary|Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)|"Subjects will evaluate the degree of their sleep disturbance due to pain and improvement in quality of sleep using the GSQA questionnaire comprising of 8 questions, at baseline (Visit 1) and Visit 6 (3 months from baseline visit).~The scores at baseline and Visit 6 are calculated for the following 8 items with scores of:~Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always~Need for pain medication to sleep -- as above~Need for sleep medication to sleep -- as above~Awakened by pain at night -- as above~Awakened by pain in the morning -- as above~Pain affecting partner's sleep -- as above~Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor~Number of hours of sleep per night in last 7 days"|Baseline, 3 months||||units on a scale||Standard Deviation|Mean
1312091|NCT02519387|Primary|Change in Box Scale-11 (BS-11) Pain Score|"The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported.~BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Baseline,3 months|These patients were eligible and included in the intent-to-treat efficacy population.|||units on a scale||Standard Deviation|Mean
1312092|NCT02518048|Secondary|Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT|"Skin thickness ultrasound measurements of the test sites were performed at Baseline and End of Treatment.~Two skin parameters were calculated using ultrasound:~The mean total skin thickness~The mean echo-poor band thickness"|Baseline to End of Treatment||||millimeters||Standard Deviation|Mean
1312093|NCT02518048|Secondary|Change in Score of Erythema, Scaling, and Infiltration at Individual Visits|"The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).~Erythema: 0 (no evidence - normal skin color) to 3 (severe - intense red). Scaling: 0 (no evidence - no scaling) to 3 (severe - coarse, thick scales). Infiltration: 0 (no evidence - no infiltration) to 3 (severe - very marked infiltration)."|Day 1 (Baseline) to Day 29||||units on a scale||Standard Deviation|Mean
1312094|NCT02518048|Secondary|Change in TCS at Individual Visits||Day 1 (Baseline) to Day 29||||units on a scale||Standard Deviation|Mean
1312095|NCT02518048|Primary|Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline|"The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).~The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site.~Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT).~The mean TCS at Baseline was 6.6 for both groups."|Day 1 (Baseline) to Day 29||||units on a scale||Standard Deviation|Mean
1312096|NCT02517580|Secondary|Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks||8 weeks|||||||
1312097|NCT02517580|Secondary|Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks||8 weeks|||||||
1312098|NCT02517580|Secondary|Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks||8 weeks|||||||
1312099|NCT02517580|Primary|Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks||8 weeks||||m/s||Standard Error|Mean
1312115|NCT02517021|Secondary|Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Acute Phase||0-24 hours||||Participants|||Count of Participants
1312116|NCT02517021|Secondary|Percentage of Patients With no Emetic Episodes in the Overall Phase||0-120 hours||||Participants|||Count of Participants
1312117|NCT02517021|Secondary|Percentage of Patients With no Emetic Episodes in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
1314937|NCT02434497|Primary|Safety and Tolerability in Terms of Growth, Weight||96 weeks||||kg|participants|Standard Deviation|Mean
1312100|NCT02517567|Primary|Tear Film Evaporation Rate|Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 1, Hour 8, each product|This analysis population includes all randomized subjects (Intent-to-Treat). To address the primary objective of comparing Lens vs. No Lens, results from all 3 study lenses are combined. Therefore, subjects (eyes) are counted multiple times in Lens group due to crossover design and number of eyes with non-missing response is reported.|||gm^-2 h|Eyes|Standard Deviation|Mean
1312101|NCT02517515|Secondary|Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 24 weeks after the last dose of active study drug|All participants who received at least 1 dose of active study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit, who had HCV RNA data available during the SVR24 period.|||percentage of participants||95% Confidence Interval|Number
1312102|NCT02517515|Secondary|Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of active study drug|All participants who received at least 1 dose of active study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit, who had HCV RNA data available during the SVR12 period.|||percentage of participants||95% Confidence Interval|Number
1312103|NCT02517515|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment.|up to 12 weeks|All participants who received at least 1 dose of active study drug.|||percentage of participants||95% Confidence Interval|Number
1312104|NCT02517515|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.|24 weeks after the last actual dose of active study drug|All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1312105|NCT02517515|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.|12 weeks after the last actual dose of active study drug|All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1312106|NCT02517463|Secondary|Change in the Length of the Index Menstrual Cycle From Baseline|shortening or lengthening of the index menstrual cycle compared to the previous menstrual pattern of the subject|one cycle (i.e. up to about 4 weeks)|Only subjects with follow-up information were included in this part of analysis|||days||Inter-Quartile Range|Median
1312107|NCT02517463|Secondary|Failure Rate|Number of subjects who got pregnant / Total number of subjects in the group|one cycle (i.e. up to about 4 weeks)||||percentage of participants|||Number
1312108|NCT02517463|Primary|Percentage of Pregnancies Prevented (PPP)||one cycle (i.e. up to about 4 weeks)||||percentage of pregnancies prevented|||Number
1312109|NCT02517047|Secondary|Forced Expiratory Volume|Forced expiratory volume measured in liters is the volume of air which can be forcibly exhaled from the lungs in the first second of a forced expiration and helps with evaluation of asthma control. FEV1 was only measure at baseline to assess the participants asthma status at baseline.|Baseline||||liters||Standard Deviation|Mean
1312110|NCT02517047|Secondary|Asthma Symptoms|Asthma symptom control as a measure of effectiveness of self-management behavior on asthma control, measured by Asthma Control Test (ACT). Asthma control test is a survey used to evaluate asthma control in patients. It includes 5 multiple questions that ask about how much of the time patient was having asthma symptoms. The higher the score the better asthma control. Lower scores especially less than 19 represent poor asthma control. each question has 5 answers. The total score is the sum of all the scores from 5 questions. the maximum score on the test is 25 which is excellent asthma control and the lowest is 0 which defines extremely poor asthma control.|12 weeks||||units on a scale||Standard Deviation|Mean
1312111|NCT02517047|Primary|Number of Participants With Rescue Inhaler Use|Total number participants with rescue inhaler use throughout the course of the study.|12 weeks||||Participants|||Count of Participants
1312112|NCT02517047|Primary|Number of Participants With Daily Medication Compliance|Total number participants who took their medication as planned will be measured. This will include measuring the number of participants with medication compliance who take their medications as planned based on the data from the monitoring device.|12 weeks||||Participants|||Count of Participants
1312113|NCT02517021|Secondary|Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Overall Phase||0-120 hours||||Participants|||Count of Participants
1312122|NCT02517021|Primary|Percentage of Patients With Adverse Events|This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to be treated with the test drug for 4 cycles. Based on 100 patients treated at Cycle 4 with the IV NEPA FDC , if a given Adverse Event (AE) is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.|Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 weeks.||||Participants|||Count of Participants
1312123|NCT02516410|Secondary|Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)|This outcome was not planned to be assessed in Placebo arm.|Pre-morning dose on Week 2, Week 4, Week 8 and Week 12|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1312124|NCT02516410|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 16 was considered treatment-emergent.|Baseline up to Week 16|Safety Set included all participants who received at least 1 dose of the study drug.|||Participants|||Number
1312125|NCT02516410|Secondary|Absolute Change From Baseline in Body Weight at Week 12||Baseline, Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Kilograms (kg)||95% Confidence Interval|Least Squares Mean
1312126|NCT02516410|Secondary|Absolute Change From Baseline in BMI Z-score at Week 12 (in Participants Less Than [<] 20 Years Old at the Time of Screening)|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age Z-score (BMI z-score). BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the paediatric population.|Baseline, Week 12|Analysis population included all randomized participants who received at least 1 dose of study drug and were <20 years of age at the time of screening.|||Z-score||95% Confidence Interval|Least Squares Mean
1312127|NCT02516410|Secondary|Number of Participants With at Least One Pulmonary Exacerbation Through Week 12|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Time-to-first pulmonary exacerbation was planned to be estimated using Kaplan-Meier (KM) estimates. However, due to less than 50% of events, time-to-first event data was not estimated. Instead, number of participants with at least one pulmonary exacerbation event were collected and are reported.|Baseline through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1312128|NCT02516410|Secondary|Absolute Change From Baseline in Sweat Chloride Through Week 12|Sweat samples were collected using an approved collection device.|Baseline, Through Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1312129|NCT02516410|Secondary|Relative Change From Baseline in Percent Predicted FEV1 Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Through Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Percent Change||95% Confidence Interval|Least Squares Mean
1312130|NCT02516410|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 12|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Kg/m^2||95% Confidence Interval|Least Squares Mean
1312131|NCT02516410|Secondary|Number of Pulmonary Exacerbation Events Per Year|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Total number of days on study is equal to the Week 12 date or the last dose date (whichever occurs last) minus first dose date plus 1. The total number of years (48 weeks) on study is equal to the total number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|Baseline through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Pulmonary exacerbation events per year|||Number
1312179|NCT02514889|Primary|Patient-centered Outcome Measure = Self-reported Hunger|"Response to question: Thinking about yesterday, how hungry did you feel during the day? Response was a mark on a 100mm scale or oral response on a scale from 0 to 100 (for participants assessed via phone), 0=Not at all hungry and 100=Extremely hungry."|12 months follow-up||||units on a scale||Standard Error|Mean
1312132|NCT02516410|Secondary|Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported.|Baseline through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Pulmonary exacerbation events|||Number
1312133|NCT02516410|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 12|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1312134|NCT02516410|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Through Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Percentage of predicted FEV1||Standard Error|Least Squares Mean
1312135|NCT02516306|Primary|Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit|"Ocular comfort was assessed at Baseline (Day 1) and following the last dose on the day prior to each office visit. Comfort was assessed by each subject marking a visual analog scale labeled 0 (Very Comfortable), 5 (Comfortable) and 10 (Very Uncomfortable) immediately following instillation of their assigned study product to one eye (Baseline) or both eyes (Days 8 - 91). A small number indicated better comfort. No formal inferential statistics hypotheses were tested."|Baseline, Day 7, Day 14, Day 30, Day 60, Day 90|Includes all subjects who completed the study: EV06 Ophthalmic Solution (49 of 50) and Placebo Ophthalmic Solution (23 of 25)|||units on a scale||Standard Deviation|Mean
1312136|NCT02516202|Secondary|Vaginal Maturation Index|Objective Measures of Genitourinary Atrophy: Vaginal Maturation Index (VMI) described by % parabasal, intermediate, and superficial cells (≤ 5% or >5% superficial cells) at week 12|Week 12|Sample includes 223 participants with VMI ≤ 5% superficial cells at baseline and non-missing VMI data at week 12|||Participants|||Count of Participants
1312137|NCT02516202|Secondary|pH|Objective measures of genitourinary atrophy: pH (<5 or >5) at week 12|Week 12|Sample includes 247 participants with pH > 5 at baseline and non-missing data on pH at week 12|||Participants|||Count of Participants
1312138|NCT02516202|Secondary|Patient Benefit Evaluation|Patient Benefit Evaluation: Overall, do you believe that you experienced a meaningful benefit from the study medication? (Yes/No).|Week 12||||Participants|||Count of Participants
1312139|NCT02516202|Secondary|Treatment Satisfaction|Likert Scale 0 = no to 10 = complete satisfaction.|Week 12||||units on a scale||Standard Deviation|Mean
1312140|NCT02516202|Secondary|Female Sexual Function Index|Female Sexual Function Index (FSFI); Evaluate dyspareunia, sexual function and distress. A composite score from 2 (not sexually active and no desire) to 36 and 6 domains.|Baseline, Week 4, Week 12||||units on a scale||95% Confidence Interval|Mean
1312141|NCT02516202|Secondary|Vaginal Symptoms Index|"Mean change from baseline to 12 weeks in composite Vaginal Symptoms Index (VSI).~The VSI is a Modified Bachman scale measuring vulvovaginal itching, dryness, irritation, soreness, and pain with sexual activity among sexually active women, each rated 0=none to 3=severe, and then averaged for a total score of 0-3."|Baseline, Week 4, Week 12|Analysis includes participants with VSI data at baseline and either week 4 or 12.|||units on a scale||95% Confidence Interval|Mean
1312142|NCT02516202|Primary|Most Bothersome Symptom (MBS) Severity|Mean change from baseline to 12 weeks in the severity of the MBS on a scale of 0-3, better to worse.|Baseline, Week 4, Week 12|Analysis includes participants with MBS data at baseline and either week 4 or 12.|||units on a scale||95% Confidence Interval|Mean
1312143|NCT02516163|Primary|Repeatability of Cutting Guide Position|Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.||||intraclass correlation coefficient (ICC)|Participants|95% Confidence Interval|Number
1312144|NCT02516150|Secondary|Maximum Change in GIR (Glucose Infusion Rate) From Baseline|This outcome is measuring the maximum change in the glucose infusion rate from the GIR at the time of the injection through the 90 minutes after the glucagon injection in the presence and absence of ethanol. The glucose infusion rate is adjusted up to every two minutes throughout the clamp, and for 90 minutes total after the glucagon injection.|1 Day Visit (approximately 8 to 11 hours)||||ml/hour||Standard Deviation|Mean
1312145|NCT02516150|Primary|AOCGIR (Area Over the Curve for Glucose Infusion Rate)|Area over the curve for the glucose infusion rate in the hour following a subcutaneous glucagon dose with a blood alcohol content of 0 vs 0.1%|1 Day Visit (approximately 8 to 11 hours)||||mg*minute/dl||Standard Deviation|Mean
1312146|NCT02516098|Secondary|Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)|Area under the concentration-time curve of hyoscine butylbromide to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®). This was calculated both for test and reference products.|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1312147|NCT02516098|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).|The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1312148|NCT02516098|Primary|AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)|Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population|||hour (h)*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1312149|NCT02516098|Primary|Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)|The maximum measured concentration of hyoscine butylbromide in plasma.|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|All subjects who had evaluable pharmacokinetic (PK) data for at least one of the treatment periods were included in the PK population.|||picogram (pg)/millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1312150|NCT02515994|Secondary|Average Wear Time|Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.|3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Hours per day||Standard Deviation|Mean
1312151|NCT02515994|Secondary|Symptoms|"Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item Experienced Eye Symptoms or Problems? were reported."|Up to 3 month Follow-up|All subjects that were dispensed a study lens.|||Eyes|Participants||Number
1312152|NCT02515994|Primary|Visual Acuity|Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.|Up to 3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Participants|Standard Deviation|Mean
1312153|NCT02515994|Primary|Slit Lamp Findings|Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.|Up to 3 Month Follow-up|All subjects that were dispensed a study lens.|||Eyes|Participants||Number
1312154|NCT02515851|Secondary|Over Satisfaction|Patients will rate satisfaction with their surgery and recovery on a 1 to 10 scale with 1 being the lest and 10 being the most satisfied.|7 days after surgery|Data were not collected||||||
1312155|NCT02515851|Secondary|Passive Wrist Range of Motion|Wrist range of motion possible when surgeon moves the wrist between 0 and 180 degrees.|7 days after surgery|Data were not collected||||||
1312156|NCT02515851|Secondary|Total Narcotic Pain Medication Usage|The total narcotic pain medication usage for 1 week after surgery|7 days after surgery|Data were not collected||||||
1312157|NCT02515851|Primary|Pain Medication Usage|the amount of pain medication used in the three days following surgery.|three days|Data were not collected||||||
1312158|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast|Blood samples were collected to assess Tlast.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||hour||Full Range|Median
1312159|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)|Blood samples were collected to assess Clast.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||ng/mL||Standard Deviation|Mean
1312160|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)|Blood samples were collected to assess AUClast.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||Hr*ng/mL||Standard Deviation|Mean
1312161|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)|Blood samples were collected to assess Tmax.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||hour||Full Range|Median
1312162|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)|Blood samples were collected to assess Cmax.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||ng/mL||Standard Deviation|Mean
1312751|NCT02499029|Secondary|Depression|Beck Depression Inventory (BDI) The BDI measures presence and severity of depression. It has 21 questions that are rated from 0-3 with a highest possible score of 63. A higher score indicates a higher severity of depression.|8 weeks||||units on a scale||Standard Deviation|Mean
1312163|NCT02515331|Primary|Change From Baseline in Mean Daytime Blood Pressure|Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement.|Baseline, day 27|The primary pharmacodynamics (PD) analysis set, which included patients that received study drug with any available PD data, was considered for the analysis. Only patients with values on both baseline and day 27 were analyzed.|||mmHg||Standard Deviation|Mean
1312164|NCT02515331|Primary|Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths|Number of participants with AEs, SAEs and deaths were assessed.|6 months|Safety analysis set: included all participants who were randomized.|||Participants|||Number
1312165|NCT02515279|Primary|Percentage of Participants With Sustained Virologic Response 24 (SVR24)|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.|18 months|All participant who were enrolled in the study. N=number of participants evaluable for this measure.|||percentage of participants|||Number
1312166|NCT02515279|Primary|Percentage of Participants With End of Treatment Response|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.|12 months|All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.|||percentage of participants|||Number
1312167|NCT02515279|Primary|Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|Up to 6 years|All participants who were enrolled in the study.|||percentage of participants|||Number
1312168|NCT02515058|Secondary|% Residual Graft Material (Histological)|histologic determination of % of residual bone graft material|3 months after ridge preservation||||percentage||Standard Deviation|Mean
1312169|NCT02515058|Primary|% Vital Bone Formation (Histological)|histologic determination of % of vital bone formation|3 months after ridge preservation||||percentage||Standard Deviation|Mean
1312170|NCT02515045|Secondary|Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)|Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign.|Month 1.||||mmHg||Standard Deviation|Mean
1312171|NCT02515045|Secondary|Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)|"Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.~An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery."|Month 1||||Microns||Standard Deviation|Mean
1312172|NCT02515045|Primary|Change From Baseline (Preoperative Exam) in Macular Thickness|Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.|Month 1.||||Microns||Standard Deviation|Mean
1312173|NCT02514889|Secondary|Waist Circumference|The waist circumference was assessed using research standard waist circumference measuring tapes. The result was measured to closest 0.1 cm. The assessor was instructed to position the measuring tape horizontally around the waist, just above the iliac crest.|12 months follow-up|Of 93 participants completing in-person follow-up visit, 1 participant did not undergo waist measurement|||cm||Standard Error|Mean
1312174|NCT02514889|Secondary|Body Mass Index|Body mass index is weight in kilograms divided by the square of the participant's height measured in meters. Wall-mounted stadiometer was used to assess height. Weekly-calibrated, portable, digital scales were used to assess body weight.|12 months follow-up||||kg/m^2||Standard Error|Mean
1312175|NCT02514889|Secondary|Systolic Blood Pressure|Systolic blood pressure assessed on participant's left arm while participant is seated, after at least 5 minutes of rest. Automated, regularly calibrated sphygmomanometer was used with oversize cuffs for obese arms.|12 months follow-up|Participants who completed in-person evaluation at 12 months follow-up|||mm of mercury (equivalent)||Standard Error|Mean
1312176|NCT02514889|Primary|Feeling Full After Last Meal Yesterday|"Take a moment to think about the last meal yesterday. Thinking about the last meal you ate, how full did you feel after that meal? Response was a mark on a 100 mm visual analogue scale (VAS), or oral response to question on a scale from 0 to 100 (for participants assessed via phone), 0=Extremely full and 100=Not at all full. For analysis purposes this measure was reverse-scored, so that higher values represented greater fullness."|12 months follow-up||||units on a scale||Standard Error|Mean
1312177|NCT02514889|Primary|Meal Satisfaction Yesterday|"Take a moment to think about the last meal you ate yesterday. Thinking about the last meal you ate, how satisfied were you after the meal? Response was a mark on a 100 mm visual analogue scale or response to oral question on a scale from 0 to 100 (for participants assessed via phone), with the low end (0) anchored by Very satisfied and the high end (100) anchored by Very unsatisfied. For analysis purposes this measure was reverse-scored, so that higher values represented greater meal satisfaction."|12 months follow-up|Participants who provided survey data at follow-up|||units on a scale||Standard Error|Mean
1312178|NCT02514889|Primary|Medical Outcome Measure = Body Weight|Body weight, measured in kilograms, was obtained by having shoeless participants dressed in light clothing stand on a regularly calibrated medical scale. Measures were taken twice. If these measures differed by more than 0.2 kg, a third measure was taken and averaged with the other two.|12 months follow-up|Participants who completed the in-person follow-up visit for anthropometric evaluation|||kilograms||Standard Error|Mean
1312180|NCT02514772|Primary|Number of Patients Experiencing Potential Infusion-Related Reactions|Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.|On the day of and on the day after each study drug infusion (e.g. on study day 1 and 2 for the 1st study drug infusion and on study day 14 and 15 for the 2nd study drug infusion, if the second drug infusion was given on study day 14)|The total number of patients, who received second infusion in GP2013 arm differs from the total number of patients in GP2013 arm due to patients withdrawn after the 1st infusion.|||Participants|||Count of Participants
1312181|NCT02514772|Primary|Immunogenicity|"Number of patients tested positive for anti-drug-antibodies (ADA) post-randomization.~Patients with negative ADA results at screening and at least one evaluable post-randomization ADA assessment are included in the analysis"|24 weeks study duration|Safety Analysis Set|||Participants|||Count of Participants
1312182|NCT02514772|Primary|Number of Patients Experiencing Hypersensitivity Reactions|The standardized MedDRA query (SMQ) - Hypersensitivity reactions (SMQ 20000214) was used for the identification of hypersensitivity reactions overall from first infusion in the adverse event database.|24 weeks study duration|Safety Analysis Set|||Participants|||Count of Participants
1312183|NCT02514772|Primary|Number of Patients Experiencing Anaphylactic Reactions|"2006 NIAID/FAAN* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion.~For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems:~Skin/mucosal tissue~Respiratory organs~Drop of systolic blood pressure (<90 mmHg or variance from baseline >30%) or associated symptoms~Gastrointestinal organs were defined as an anaphylactic reaction.~The same criteria were also applied to patients with history of infusion-related reactions during their previous treatments with rituximab. In addition, if these patients experienced only a rapid drop in systolic blood pressure (<90 mmHg or variance from baseline >30%), this was defined as an anaphylactic reaction disregarding involvement of other organ systems.~* NIAID - National Institute of Allergy and Infectious Diseases FAAN - Food Allergy and Anaphylaxis Network"|Within 24 hours of each study drug infusion: on Day 1 and Day 14|Safety Analysis Set|||Participants|||Count of Participants
1312184|NCT02514473|Secondary|Average Pre-dose Concentration (Ctrough,Ave) and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Ave) For Lumacaftor and Ivacaftor|Ctrough,ave is average of individual pre-dose observed concentrations across Week 4 and 24. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 1, 15 and Week 4. This outcome was not planned to be assessed in Placebo arm.|For Ctrough,ave: before morning dose on Week 4 and 24; For C3-6h,ave: 3 to 6 hours after morning dose on Day 1, 15 and Week 4|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1312185|NCT02514473|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 28 was considered treatment-emergent.|Baseline up to Week 28|Safety Set included all participants who were exposed to any amount of study drug.|||participants|||Number
1312186|NCT02514473|Secondary|Time-to-first Pulmonary Exacerbation|Time-to-first pulmonary exacerbation was analyzed using the Kaplan-Meier estimates. Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|Baseline through Week 24|FAS.|||Days||Inter-Quartile Range|Median
1312187|NCT02514473|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|Baseline through Week 24|FAS.|||Percentage of participants|||Number
1312188|NCT02514473|Secondary|Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported.|Baseline through Week 24|FAS.|||Pulmonary exacerbation events|||Number
1312189|NCT02514473|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domains Through Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Through Week 24|FAS. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||Units on a scale||Standard Error|Least Squares Mean
1312190|NCT02514473|Secondary|Absolute Change From Baseline in Height-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score (height z-score). The height-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Z-score||Standard Error|Least Squares Mean
1312191|NCT02514473|Secondary|Absolute Change From Baseline in Height at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Centimeter (cm)||Standard Error|Least Squares Mean
1327526|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine epinephrine|baseline||||percentage of max platelet aggregation||Inter-Quartile Range|Median
1312192|NCT02514473|Secondary|Absolute Change From Baseline in Weight-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (weight z-score). The weight-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Z-score||Standard Error|Least Squares Mean
1312193|NCT02514473|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Kg||Standard Error|Least Squares Mean
1312194|NCT02514473|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score). The BMI-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Z-score||Standard Error|Least Squares Mean
1312195|NCT02514473|Secondary|Relative Change From Baseline in ppFEV1 Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Wang standards were used to calculate ppFEV1 (for age, gender, race, and height).|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
1312196|NCT02514473|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Wang standards were used to calculate ppFEV1 (for age, gender, race, and height).|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent predicted of FEV1||Standard Error|Least Squares Mean
1312197|NCT02514473|Secondary|Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved collection device.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol/L||Standard Error|Least Squares Mean
1312198|NCT02514473|Secondary|Absolute Change From Baseline in Lung Clearance Index 5.0 (LCI5.0) Through Week 24|LCI is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Ratio||Standard Error|Least Squares Mean
1312199|NCT02514473|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
1312200|NCT02514473|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kg divided by height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Kg/m^2||Standard Error|Least Squares Mean
1312201|NCT02514473|Secondary|Average Absolute Change From Baseline in Sweat Chloride at Day 15 and Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. Change from Baseline in sweat chloride at Day 15 and Week 4 was calculated. The average of the 2 values (Change at Day 15 and Week 4) was reported.|Baseline, Day 15 and Week 4|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1312202|NCT02514473|Primary|Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|Baseline, Through Week 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Ratio||Standard Error|Least Squares Mean
1312203|NCT02514044|Secondary|Percent Change in Blood Pressure|Non-invasive BP measurements performed by a clinician before and after each experiment.|immediately before the treatment, after after the treatment||||percent change in blood pressure||Standard Deviation|Mean
1312204|NCT02514044|Secondary|Boston Diagnostic Aphasia Examination||Baseline,2 months|Data not collected.||||||
1312205|NCT02514044|Secondary|Boston Diagnostic Aphasia Examination||Baseline,2 weeks|Data not collected.||||||
1312206|NCT02514044|Primary|Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery|The score on the Aphasia Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.|immediately before the treatment, immediately after the treatment||||percent change in aphasia quotient||95% Confidence Interval|Mean
1312207|NCT02514044|Primary|Percent Change in Language Quotient as Assessed by the Western Aphasia Battery|The score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.|immediately before the treatment, immediately after the treatment||||percent change in language quotient||95% Confidence Interval|Mean
1312208|NCT02513771|Secondary|Number of Participants With Grade ≥2 Adverse Events Related to Study Drug|The DAIDS Adverse Event Grading Table, Version 2.0, was used for grading of AEs|From study entry to end of study (Week 20)|All enrolled participants|||Participants|||Count of Participants
1312209|NCT02513771|Secondary|Change in %CD14dim/CD16++ (Non-classical Monocytes)|"%CD14dim/CD16++ is the percentage of cells that expressed low levels of CD14dim and high levels of CD16++ in total monocytes (also known as non-classical monocytes).~This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
1312210|NCT02513771|Secondary|Change in %CD14+/CD16+ (Intermediate Monocytes)|"%CD14+/CD16+ is the percentage of cells that expressed both CD14 and CD16 in total monocytes (also known as intermediate monocytes).~This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
1312211|NCT02513771|Secondary|Change in %CD14+/CD16- (Classical Monocytes)|"CD14+/CD16- is the percentage of cells that expressed CD14 and low CD16 in total monocytes (also known as classical monocytes).~This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of November 2017. The study team prioritized completion of the soluble markers (including the primary outcome measure), which are reported herein, over the completion of the cellular markers. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
1312212|NCT02513771|Secondary|Change in CD8+ T-cell Activation|"Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.~The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
1312213|NCT02513771|Secondary|Change in CD4+ T-cell Activation|"Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.~The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
1312214|NCT02513771|Secondary|Change in CD4+/CD8+ T-cell Ratio|CD4+/CD8+ T-cell ratio change from week 0 to week 15 (week 15 - week 0). Note that CD4 and CD8 were not evaluated at week 20 in this study.|Week 0 and week 15|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||ratio||Inter-Quartile Range|Median
1312215|NCT02513771|Secondary|Change in IP-10|"IP-10 (also known as CXCL10) is a biomarker implicated in cardiovascular disease.~Change in log10 transformed IP-10 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
1312216|NCT02513771|Secondary|Change in sTNF-r2|"sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a biomarker of inflammation.~Change in log10 transformed sTNF-r2 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
1312217|NCT02513771|Secondary|Change in sTNF-r1|"sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a biomarker of inflammation.~Change in log10 transformed sTNF-r1 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
1312218|NCT02513771|Secondary|Change in hsCRP|hsCRP (high-sensitivity C-reactive protein) is a biomarker of inflammation. Change in log10 transformed hsCRP from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 ng/mL||Inter-Quartile Range|Median
1312219|NCT02513771|Secondary|Change in IL-6|IL-6 (Interleukin-6) is a biomarker of systemic inflammation. Change in log10 transformed IL-6 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
1312220|NCT02513771|Secondary|Change in sCD26|"sCD26 (soluble cluster of differentiation 26) is an enzyme that metabolizes DPP-4 (dipeptidyl peptidase-4), an enzyme that is inhibited by sitagliptin.~Change in log10 transformed sCD26 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 ng/mL||Inter-Quartile Range|Median
1312221|NCT02513771|Secondary|Change in sCD163|"sCD163 (soluble CD 163) is a marker of macrophage activation and arterial inflammation.~Change in log10 transformed sCD163 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 ng/mL||Inter-Quartile Range|Median
1312222|NCT02513771|Secondary|Change in sCD14 From Week 15/16 to Week 20|"sCD14 (soluble cluster of differentiation 14) is a biomarker of gut microbial translocation and monocyte/macrophage activation.~The outcome measures are changes in log10 transformed sCD14 from week 15/16 to week 20 (week 20 - week 15/16).~Levels measured at week 15 and week 16 were averaged for week 15/16."|Week 15, week 16, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
1312223|NCT02513771|Primary|Change in sCD14 From Baseline to Week 15/16|"sCD14 (soluble cluster of differentiation 14) is a biomarker of gut microbial translocation and monocyte/macrophage activation.~The outcome measures are changes in log10 transformed sCD14 from baseline to week 15/16 (week 15/16 - baseline) Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 15 and week 16 were averaged for week 15/16."|Pre-entry, Week 0, Week 15, Week 16|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
1312224|NCT02513550|Secondary|Number of Participants With Anti-Ixekizumab Antibodies|Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.|Baseline through Week 52|All randomized participants who received at least 1 dose of Ixekizumab and had evaluable anti-ixekizumab antibody measurement.|||participants|||Number
1312225|NCT02513550|Secondary|Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab|Trough concentrations at steady state of Ixekizumab were evaluated.|Predose, Week 4, 12, 24, 36 and 52 Post dose|All randomized participants analyzed according to the treatment to which they were assigned with evaluable PK samples that met the definition of being a trough concentration.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1312226|NCT02513550|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS|EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post baseline EQ-5D-5L VAS data.|||mm||Standard Error|Least Squares Mean
1312258|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Vital Sign Parameters and Physical Findings|Vital signs (blood pressure, temperature, pulse, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population|||Participants|||Number
1312227|NCT02513550|Secondary|Change From Baseline in Skin Pain Visual Analog Scale (VAS)|The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline skin pain VAS data.|||mm||Standard Error|Least Squares Mean
1312228|NCT02513550|Secondary|Change From Baseline in Itch NRS Score|The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline Itch NRS data.|||units on a scale||Standard Error|Least Squares Mean
1312229|NCT02513550|Secondary|Change From Baseline in DLQI Total Score|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline DLQI data.|||units on a scale||Standard Error|Least Squares Mean
1312230|NCT02513550|Secondary|Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment)."|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of participants|||Number
1312231|NCT02513550|Secondary|Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline|The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline Itch NRS score greater than or equal to (>=) 4. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of participants|||Number
1312232|NCT02513550|Secondary|Mean Change From Baseline in Palmoplantar PASI (PPASI)|The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had baseline palmoplantar Ps involvement and had a post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1312233|NCT02513550|Secondary|Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had baseline scalp involvement and had a post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1312259|NCT02512900|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is any AE resulting in any of the following outcomes such as death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population: All participants who received any treatment of MEDI9929.|||Participants|||Number
1312234|NCT02513550|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned who had baseline fingernail involvement and had a post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1312235|NCT02513550|Secondary|Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement|"The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.~LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned who had baseline and a post-baseline measurement for BSA affected by Psoriasis.|||Percent Body Surface Affected||Standard Error|Least Squares Mean
1312236|NCT02513550|Secondary|Percent Improvement in PASI|"The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.~Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI.|||Percent change||Standard Error|Least Squares Mean
1312237|NCT02513550|Secondary|Change From Baseline in PASI|"The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.~Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI.|||units on a scale||Standard Error|Least Squares Mean
1312238|NCT02513550|Secondary|Percentage of Participants Achieving PASI 100|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 52|All randomized participants analyzed according to the treatment to which they were assigned.|||Percentage of participants|||Number
1312239|NCT02513550|Secondary|Percentage of Participants Achieving PASI 90|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 52|All randomized participants analyzed according to the treatment to which they were assigned.|||Percentage of participants|||Number
1312240|NCT02513550|Secondary|Percentage of Participants Achieving sPGA (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of “0” or “1” with at least a 2-point improvement from baseline.|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of participants|||Number
1312260|NCT02512900|Primary|Apparent Steady-state Volume of Distribution (Vss/F)|The PK parameter Vss/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Liter||Standard Deviation|Mean
1312261|NCT02512900|Primary|Apparent Clearance (CL/F)|The PK parameter CL/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Liter/day||Standard Deviation|Mean
1312241|NCT02513550|Primary|Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of participants|||Number
1312242|NCT02513550|Primary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)|The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of “0” or “1” with at least a 2-point improvement from baseline.|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of participants|||Number
1312243|NCT02513160|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly/birth defect, or an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the patient and may require medical intervention to prevent one of the outcomes listed in this definition.|Day 0 to Week 6|The safety analysis set included all randomly assigned patients (ITT analysis set) who received at least 1 dose of study drug. In this analysis set, treatment was assigned based on the treatment patients actually received, regardless of the treatment to which they were randomly assigned.|||Participants|||Count of Participants
1312244|NCT02513160|Secondary|Count of Participants Withdrawn From Study Drug Treatment Due to Meeting Stopping Criteria for Worsening Asthma|"Number of participants who were withdrawn from study drug due to worsening asthma. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient’s overall clinical picture was consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of an alert criteria is:~Morning FEV1 by handheld spirometer as measured at home falls below the FEV1 stability limit (FEV1 <80%) as calculated at the screening visit for the Run-in Period and at the randomization visit (Day 0) for the Treatment Period on 4 or more days out of any 7-day period."|Day 0 to Week 6|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||Participants|||Count of Participants
1312245|NCT02513160|Secondary|Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 6-Week Treatment Period|Asthma symptom scores were recorded in the patient’s diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications. The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9. Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asth|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||units on a scale||Standard Error|Least Squares Mean
1312246|NCT02513160|Secondary|Change From Baseline in Weekly Average of Total Daily (24-Hour) Rescue Medication Use Over the 6-Week Treatment Period|Change from baseline in the weekly average of total daily (24-hour) use of albuterol/salbutamol inhalation aerosol over weeks 1 through 6. Patients recorded the number of inhalations (puffs used) of rescue medication (albuterol/salbutamol HFA MDI [90 mcg ex-actuator] or equivalent) each morning and evening in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value and was compared with the rescue medication use during the 6-week treatment period.|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||number of inhalations||Standard Error|Least Squares Mean
1312262|NCT02512900|Primary|Terminal Phase Elimination Half Life (t1/2,z)|The t½,z is the time measured for the serum drug concentration of MEDI9929 to decrease by one half. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Day||Standard Deviation|Mean
1312247|NCT02513160|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Forced Expiratory Volume in One Minute (FEV1) Rate Over the 6-Week Treatment Period|Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) FEV1 by handheld spirometer over the 6-week treatment period. FEV1 were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening FEV1 throughout the study. The spirometer was programmed to record the highest FEV1 obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning FEV1 assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||milliliters||Standard Error|Least Squares Mean
1312248|NCT02513160|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 6-Week Treatment Period|Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 6-week treatment period. PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Timeframes: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||liters/minute||Standard Error|Least Squares Mean
1312249|NCT02513160|Primary|Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 6 Weeks (AUEC(0-6wk))|The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-6wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit, each treatment visit (Weeks 2, 4 and 6) and any unscheduled visit (such as the early termination visit). The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.|Baseline (Day 0 of Treatment Period), weeks 2, 4, 6|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||milliliters||Standard Error|Least Squares Mean
1312250|NCT02513095|Other Pre-specified|Acute Renal Failure|Acute renal failure as measured by increase in serum creatinine; decrease in urine volume|72 hours|||||||
1312251|NCT02513095|Other Pre-specified|Duration of Hospital Stay|Measure of the length of hospital stay|Up to 72 hours|||||||
1312252|NCT02513095|Other Pre-specified|Lactate Plasma Level|Changes from baseline in systemic lactate level|72 hour duration of study|||||||
1312253|NCT02513095|Secondary|Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 Over the Course of the Study|Cumulative incidence of subjects who achieve a GCS of ≥ 13 over the course of the study|Study duration|||||||
1312254|NCT02513095|Primary|Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13|Cumulative incidence of subjects achieving a GCS ≥ 13 at or prior to 90 minutes post-randomization|90 minutes post-randomization||||Participants|||Count of Participants
1312255|NCT02512900|Secondary|Number of Participants Positive for Anti-drug Antibodies and With Neutralizing Antibodies for MEDI9929 at Any Visit|Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The incidence rate of positive serum antibodies to MEDI9929 were presented.|Days 1 (predose), 29, 57 and 85|As-treated Population. Neutralizing antibody was tested only for the positive ADA samples. Combined immunogenicity data is presented for all participants (that is 12 to 17 years of age). n= Number of participants analyzed for this outcome measure at the given time point.|||Participants|||Number
1312256|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|Computerized triplicate 12-lead ECGs as well as Qualitative 12-lead ECGs were obtained during the study. ECG parameters included heart rate, PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with TEAEs related to ECG after the start of study drug were to be reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population|||Participants|||Number
1312257|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell count with differential, red blood cell count, hematocrit, hemoglobin and platelet count); serum chemistry: calcium, chloride, potassium, sodium, bicarbonate, aspartate transaminase, alanine transaminase, albumin, uric acid, creatinine, total bilirubin, glucose, alkaline phosphatase, blood urea nitrogen, total protein, and gamma glutamyl transferase; and urinalysis (nitrites, protein, glucose, ketones, urine drug screen, blood, and bilirubin). Number of participants with TEAEs related to laboratory evaluations were reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population|||Participants|||Number
1327527|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine diphosphate|2 hours||||percentage of max platelet aggregation||Inter-Quartile Range|Median
1312263|NCT02512900|Primary|Time to Reach Cmax (Tmax)|The Tmax is the time to maximum observed serum concentration of MEDI9929. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Day||Full Range|Median
1312264|NCT02512900|Primary|Dose-normalized Cmax (Cmax/D)|The Cmax/D is the maximum observed concentration post dose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg/mL/mg||Standard Deviation|Mean
1312265|NCT02512900|Primary|Maximum Observed Serum Concentration (Cmax)|The PK parameter Cmax was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg/mL||Standard Deviation|Mean
1312266|NCT02512900|Primary|Dose-normalized AUC (0-infinity) (AUC [0 Infinity]/D)|The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg*day/mL/mg||Standard Deviation|Mean
1312267|NCT02512900|Primary|Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t])|The PK parameter AUC (0-t) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg*day/mL||Standard Deviation|Mean
1312268|NCT02512900|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|The pharmacokinetic (PK) parameter AUC (0 to infinity) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population: All participants who received MEDI9929 and have a sufficient number of serum concentration measurements for computing PK parameters.|||μg*day/mL||Standard Deviation|Mean
1312269|NCT02512861|Secondary|Postoperative Cortisol Levels||36 hours post-surgery||||microgram/deciliter||Inter-Quartile Range|Median
1312270|NCT02512861|Secondary|Postoperative Pain Scores-State Behavioral Scale (SBS)|State Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome).|Day of Surgery||||score on a scale||Inter-Quartile Range|Median
1312271|NCT02512861|Secondary|Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale|Face, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome).|Day of Surgery||||score on a scale||Inter-Quartile Range|Median
1312272|NCT02512861|Secondary|Postoperative Cortisol Levels||12 hours post-surgery||||microgram/deciliter||Inter-Quartile Range|Median
1312273|NCT02512861|Secondary|Postoperative Length of Intubation||5 days post cardiac surgery||||hours||Inter-Quartile Range|Median
1312274|NCT02512861|Primary|Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1||Day of Surgery and Postoperative Day 1||||mcg/kg/day||Inter-Quartile Range|Median
1312275|NCT02512861|Primary|Total Fentanyl/Equivalent Day 0-1||Day of Surgery and Postoperative Day 1||||mcg/kg/day||Inter-Quartile Range|Median
1312276|NCT02512783|Secondary|Parental Assessment of Child's Pain on a Visual Analog Scale||Immediately following propofol injection|This data was not collected.||||||
1312277|NCT02512783|Primary|Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score|The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.|1 minute before propofol induction compared to 1 minute following propofol induction||||units on a scale||Standard Deviation|Mean
1312278|NCT02512679|Secondary|Number of Participants Who Were Disease Progression-Free and Death-Free at 1 Year Post-transplant|Evaluation for engraftment, correction of the disease, transplant related complications and event-free survival and overall survival of the subjects post-transplant was undertaken by standard measures and evaluation of disease with disease-specific testing.|1 yr|Subjects receiving dose level 1 of Cyclophosphamide event free survival post transplant at 100 days was 95% and 90% 1 year.|||participants|||Number
1312279|NCT02512679|Secondary|Number of Participants Who Developed Graft-Versus-Host-Disease (GVHD) as Determined by the Glucksberg Scale|Clinical evaluation on a daily basis during hospitalization and at each post transplant clinical visit, up to one year, to determine incidence of acute and chronic graft-versus-host disease using Glucksberg grading scale. Acute graft-versus-host disease (aGVHD) develops within the first three months after transplantation and appears as a skin rash, often accompanied by hyperbilirubenemia, abnormal liver enzymes and gastrointestinal symptoms, as diarrhea, nausea and vomiting. Level of aGVHD is graded from 1-4. Chronic GVHD, typically a late complication of Blood and Marrow Transplantation (BMT) characterized by skin changes, sometimes sclerotic changes, with joint contractures, liver function abnormality, gastrointestinal symptoms and sometime other organ involvement such as eyes, lungs, and obliterative bronchiolitis (OB). Chronic GVHD is graded as absent, limited, or extensive.|1 yr|Subjects who received dose level 1 of Cyclophosphamide were revaluated for graft-versus-host disease (GVHD) post transplantation.|||participants|||Number
1312280|NCT02512679|Primary|Number of Participants Who Developed Severe Mucositis, Veno-occlusive Disease (VOD), Toxicity of the Kidney, Liver, or Gastrointestinal (GI) Tract up to 1 Year Post-transplant|Assessment of conditioning regimen related toxicity was evaluated and documented with daily assessment during hospitalization and post-transplant follow-up up to one year. None of the subjects developed VOD necessitating any therapeutic intervention, severe mucositis, or toxicity of the Kidney, Liver or Gastrointestinal.|1 year|Subjects who received dose level 1 of Cyclophosphamide did not experience veno-occlusive disease, organ failure or severe mucositis.|||participants|||Number
1312281|NCT02512679|Primary|Number of Participants With Disease Recurrence at 1 Year Post-transplant|assess rate of disease recurrence (“late relapse”) due to autologous recovery of recipient hematopoiesis at one year post-HSCT.|1 year|All subjects who received dose level 1 of Cyclophosphamide did not experience re-occurrence of disease.|||participants|||Number
1312282|NCT02512679|Primary|Number of Participants With Neutrophil Engraftment (=/>500 Cells/uL) and Platelet Engraftment (>20K Cell/uL) at 30 Days|Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20,000 per cubic milimeter (20K) - evaluation by Chimerism Study (STR or FISH) at day +30|30 days|Subject enrolled and received Dose Level 1 of Cyclophosphamide and engrafted with Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20k - evaluation by Chimerism Study (STR or FISH) at day +30.|||participants|||Number
1312283|NCT02512393|Secondary|Interleukin 10 (IL-10) Level||day 5||||pg/mL||Standard Deviation|Mean
1312284|NCT02512393|Secondary|Interleukin 10 (IL-10) Level||baseline||||pg/mL||Standard Deviation|Mean
1312285|NCT02512393|Secondary|Interleukin 6 (IL-6) Level||day 5||||pg/mL||Standard Deviation|Mean
1312286|NCT02512393|Secondary|Interleukin 6 (IL-6) Level||baseline||||pg/mL||Standard Deviation|Mean
1312287|NCT02512393|Secondary|Tumor Necrosis Factor (TNF) Level||day 5||||pg/mL||Standard Deviation|Mean
1312288|NCT02512393|Secondary|Tumor Necrosis Factor (TNF) Level||baseline||||pg/mL||Standard Deviation|Mean
1312289|NCT02512393|Secondary|C-reactive Protein (CRP) Level||day 5||||ng/mL||Standard Deviation|Mean
1312290|NCT02512393|Secondary|C-reactive Protein (CRP) Level||baseline||||ng/mL||Standard Deviation|Mean
1312291|NCT02512393|Secondary|Cortisol Level||day 5||||pg/mL||Standard Deviation|Mean
1312292|NCT02512393|Secondary|Cortisol Level||baseline||||pg/mL||Standard Deviation|Mean
1312293|NCT02512393|Secondary|Endorphin Level||day 5||||ng/mL||Standard Deviation|Mean
1312294|NCT02512393|Other Pre-specified|Pain Attitudes Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire to assess pain attitudes, such as stoicism, using a 5-point scale that ranges from strongly disagree to strongly agree. The higher the scale the more stoic.|Change from baseline and day 5|||||||
1312295|NCT02512393|Other Pre-specified|Positive and Negative Affect Scale Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire using a 5-point scale that ranges from very slightly or not at all to extremely. The lower the scale the negative the affect and the higher the scare the positive the affect.|Change from baseline and day 5|||||||
1312296|NCT02512393|Other Pre-specified|Coping Strategies Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire to assess pain coping strategies, such as distancing from pain, using a 7-point scale that ranges from never do that to always do that. The higher the scale the greater use.|Change from baseline and day 5|||||||
1312297|NCT02512393|Other Pre-specified|Safety Questionnaire Will be Compared Between the Two Groups for a Change Between Baseline, 1, 2, 3, 4, and 5 Days.|This is a questionnaire to assess the presence and severity of adverse events such as headache, tingling, itching, and fatigue, on a scale of 0 to 10, with 0 being not at all and 10 being a highest degree.|Change from baseline, 1, 2, 3, 4, and 5 days|||||||
1312298|NCT02512393|Other Pre-specified|NIH PROMIS-cognition Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|A score of 50 is the average and a score of 60 is better than average. A score of 40 is the worse score.|Change from baseline and day 5|||||||
1312299|NCT02512393|Secondary|Endorphin Level||baseline||||ng/mL||Standard Deviation|Mean
1312300|NCT02512393|Primary|Conditioned Pain Modulation (CPM)|Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.|day 5||||units on a scale||Standard Deviation|Mean
1312301|NCT02512393|Primary|Conditioned Pain Modulation (CPM)|Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.|baseline||||units on a scale||Standard Deviation|Mean
1312302|NCT02512393|Primary|Punctate Mechanical Pain Sensitivity|Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.|day 5||||kilopascal (kPa)||Standard Deviation|Mean
1312303|NCT02512393|Primary|Punctate Mechanical Pain Sensitivity|Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.|baseline||||kilopascal (kPa)||Standard Deviation|Mean
1312304|NCT02512393|Primary|Pressure Pain Threshold|Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.|day 5||||kilopascal (kPa)||Standard Deviation|Mean
1312305|NCT02512393|Primary|Pressure Pain Threshold|Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.|baseline||||kilopascal (kPa)||Standard Deviation|Mean
1312306|NCT02512393|Primary|Heat Pain Tolerance|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|day 5||||Celsius||Standard Deviation|Mean
1312307|NCT02512393|Primary|Heat Pain Tolerance|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|baseline||||Celsius||Standard Deviation|Mean
1312308|NCT02512393|Primary|Heat Pain Threshold|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|day 5||||Celsius||Standard Deviation|Mean
1312309|NCT02512393|Primary|Heat Pain Threshold|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|baseline||||Celsius||Standard Deviation|Mean
1312310|NCT02512393|Primary|Short Physical Performance Battery (SPPB)|This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).|day 5||||units on a scale||Standard Deviation|Mean
1312311|NCT02512393|Primary|Short Physical Performance Battery (SPPB)|This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).|baseline||||units on a scale||Standard Deviation|Mean
1312312|NCT02512393|Primary|Six-minute Walk Test|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.|day 5||||meters||Standard Deviation|Mean
1312313|NCT02512393|Primary|Six-minute Walk Test|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.|baseline||||meters||Standard Deviation|Mean
1312314|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
1312315|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
1312316|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
1312317|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
1312318|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale|This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme. The higher the score, the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
1312319|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
1312320|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
1312321|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
1312322|NCT02512393|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
1312323|NCT02512393|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
1312324|NCT02512393|Primary|Numeric Rating Scale (NRS) for Pain|Numeric Rating Scale for pain is an 101–point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
1312325|NCT02512393|Primary|Numeric Rating Scale (NRS) for Pain|Numeric Rating Scale for pain is an 101–point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
1312326|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 30 Days||30 days after the start of the procedure||||participants|||Number
1312327|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 14 Days||14 days after the start of the procedure||||Participants|||Number
1312328|NCT02512224|Secondary|Re-admission 30 Days||re-admission within 30 days of discharge.||||Participants|||Number
1312329|NCT02512224|Secondary|Post-procedural Sepsis||the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.||||Participants|||Number
1312330|NCT02512224|Secondary|Post-procedural Pneumonia||the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.||||Participants|||Number
1312331|NCT02512224|Primary|Mortality Calculated From Outcome Section From DPC Database at 90 Days||90 days after the start of the procedure||||Participants|||Number
1312332|NCT02512094|Primary|Score of the Barthel Index|"Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).~Score was reported as mean score of the Barthel Index."|up to 1 month|All patients were analyzed using descriptive statistics.|||units on a scale||Standard Deviation|Mean
1312333|NCT02511782|Primary|CXCL10 in Plasma|Plasma was used to assess CXCL10 levels from blood.|At time of GVHD diagnosis.|We did not analyze the plasma collected from patients with chronic skin GVHD; therefore, there is no data to report. We did not analyze all acute GVHD samples for financial reasons.|||Plasma CXCL10 picograms/microliters||Standard Error|Mean
1327528|NCT02140372|Primary|Monocyte Platelet Aggregate: 2 Hours||2 Hours||||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
1312339|NCT02511431|Primary|Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment|The number of participants who experienced a > 2 log IU/mL decline in serum HDV RNA at 12 weeks of treatment|12 weeks||||Participants|||Count of Participants
1312340|NCT02510820|Primary|Overall Score|Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.|1 week, 2 weeks, 4 weeks|Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue).|||units on a scale||Standard Deviation|Mean
1312341|NCT02510820|Primary|Ease of Use of Solution|Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy|1 week, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
1312342|NCT02510820|Primary|Ease of Lens Removal|Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312343|NCT02510820|Primary|Ease of Lens Insertion|Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312344|NCT02510820|Primary|Ocular Redness|Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312345|NCT02510820|Primary|Burning/Stinging|Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.|1 week, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
1312346|NCT02510820|Primary|Dryness|Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.|1 week, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
1312347|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312348|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|2 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312349|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|1 week|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312350|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312351|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|2 weeks|The difference in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312352|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|1 week||||units on a scale||Standard Deviation|Mean
1312353|NCT02510820|Primary|Papillary Conjunctivitis|Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312354|NCT02510820|Primary|Corneal Staining|Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312355|NCT02510820|Primary|Limbal Hyperaemia|Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312356|NCT02510820|Primary|Conjunctival Hyperaemia|Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
1312357|NCT02510014|Secondary|Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49)|"Participants’ self-reported illicit opioid drug use from the timeline followback (TLFB) interview and results from the urine drug screens (UDS) for opioids were combined into a single endpoint. Opioids assessed included codeine, hydrocodone, hydromorphone, methadone, morphine, opiates, oxycodone, and oxymorphone (by UDS) and amphetamine/methadone, buprenorphine, methadone, and opioids in the TLFB.~Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. All missing reports for opioids were considered nonnegative."|Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25|Safety analysis set|||Participants|||Count of Participants
1312358|NCT02510014|Secondary|Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)|"The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values."|Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set|||units on a scale||Standard Deviation|Mean
1312359|NCT02510014|Secondary|Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)|"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values."|Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set|||units on a scale||Standard Deviation|Mean
1312360|NCT02510014|Secondary|Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)|"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values."|Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set|||units on a scale||Standard Deviation|Mean
1312361|NCT02510014|Primary|Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)|"Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.~The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.~Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented.~De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309.~Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141."|De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141|Safety analysis set|||units on a scale||Standard Deviation|Mean
1312362|NCT02510014|Primary|Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period|"The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. Only the most severe assessment is reported in this summary. Participants who experienced suicidal ideation and suicidal behavior are only summarized in the suicidal behavior since behavior is more severe than ideation.~C-SSRS baseline version was completed during the screening visit. C-SSRS 'since-last-visit' version was completed weekly for the first month and at least every month until the end of the study.~Shift table category titles are structured as: baseline category/treatment category. The category 'No Suicidal Ideation or Behaviour' has been abbreviated as 'No Suicidal I or B'."|Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety population. Four de novo subjects and one roll-over subject are not reported because they used the C-SSRS baseline version throughout the study.|||Participants|||Count of Participants
1312363|NCT02510014|Primary|Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs|"Vital signs include~systolic blood pressure (mmHg)~diastolic blood pressure (mmHg)~respiratory rate (breaths/minute)~weight (kg)~body mass index (kg/m^2)~waist-to-hip ratio~Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1."|Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set of participants with both a baseline and end of study reading|||percentage change from baseline||Standard Deviation|Mean
1312448|NCT02506660|Secondary|Numerical Rating Scale Pain Scores|The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. “no pain”) to '10' representing the other pain extreme (e.g. “pain as bad as you can imagine” or “worst pain imaginable”)|Duration of stay in recovery room after surgery (average of 3 hours)||||Units on a Scale||Inter-Quartile Range|Median
1312364|NCT02510014|Primary|Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period|TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition.|Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)|Safety analysis set|||Participants|||Count of Participants
1312365|NCT02509065|Secondary|Total Glucagon Dosing by the Bihormonal Bionic Pancreas From the Start of Exercise Until the End of the Visit|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||mcg/kg||Standard Deviation|Mean
1312366|NCT02509065|Secondary|Grams of Carbohydrates Given to the Subject to Treat Hypoglycemia|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||grams of carbohydrates||Standard Deviation|Mean
1312367|NCT02509065|Secondary|Time From Start of Exercise to First CGM Measurement < 60 mg/dl|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||minutes||Standard Deviation|Mean
1312368|NCT02509065|Secondary|Time From Start of Exercise to First BG Measurement < 60 mg/dl|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)||||minutes||Standard Deviation|Mean
1312369|NCT02509065|Secondary|Area Between the Glucose Curve and 60 mg/dl Calculated From CGM Measurements|CGM glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of every 5 minutes|Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)||||min*mg/dl||Standard Deviation|Mean
1312370|NCT02509065|Secondary|Area Between the Glucose Curve and 60 mg/dl Calculated From BG Measurements|Plasma glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of at least every 10 minutes throughout.|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||min*mg/dl||Standard Deviation|Mean
1312371|NCT02509065|Secondary|Percentage of Subjects With Mean CGM < 154 mg/dl|The percentage of subjects who's mean CGM glucose level is < 154 mg/dl, which is an estimated hemoglobin a1c < 7%, which is the ADA goal for therapy|Days 2-3||||Participants|||Count of Participants
1312372|NCT02509065|Secondary|Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl|The fraction of time spent in each of these ranges according to continuous glucose monitor readings|Days 2-3||||percentage of time||Standard Deviation|Mean
1312373|NCT02509065|Secondary|Nausea Severity|The average severity of nausea, as recorded on a 10 centimeter visual analog scale by the daily e-mail survey they receive. Scores were determined by how many centimeters the subject marked as a surrogate for their nausea level on a daily basis. Any value more than 0 cm indicates some degree of nausea with a score of 10 cm being the worst nausea imaginable. A score less than 3 cm indicates a mild level of nausea.|Days 1-3||||score on a scale 0-10 cm||Standard Deviation|Mean
1312374|NCT02509065|Secondary|Mean CGM Glucose|Average glucose according to continuous glucose monitor readings including the 1 day washout|Days 1 through 3||||mg/dl||Standard Deviation|Mean
1312375|NCT02509065|Primary|Number of Subjects Discordant for Reaching a BG < 60 mg/dl for > 2 Consecutive Plasma Glucose Measurements During Inpatient Exercise Visit|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||Participants|||Count of Participants
1312376|NCT02509065|Primary|Percentage of Time With CGM < 60 mg/dl|For this calculation we analyzed data from every 5 minutes of CGM data for days 2 and 3 of each study arm. We looked specifically at the percentage time of those roughly 48 hours that had any glucose values less than 60 mg/dl. The final value presented is the percent of time per 2 days of the study arm spent in a specific hypoglycemia range of less than 60 mg/dl with an associated standard deviation.|Days 2 and 3||||percentage of time||Standard Deviation|Mean
1312377|NCT02509065|Primary|Mean Continuous Glucose Monitor (CGM) Glucose Values|Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm.|Days 2 and 3||||mg/dl||Standard Deviation|Mean
1312378|NCT02508207|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline up to Day 57|The Safety Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1312379|NCT02508207|Secondary|Absolute Change From Baseline in Sweat Chloride at Day 29||Baseline, Day 29|The FAS was used. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||millimoles per liter||Standard Deviation|Mean
1312380|NCT02508207|Secondary|Absolute Change From Baseline in Small-bowel Area Under the Curve (AUC) Over 1-minute Mean pH Increments at Day 29|Absolute change from Baseline in small bowel AUC over 1-minute mean pH increments through 30 minutes at Day 29 was assessed.|Baseline, Day 29|"The FAS was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||pH minutes||Standard Deviation|Mean
1312381|NCT02508207|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 28|Percent predicted FEV1 is the ratio of FEV1 to the predicted FEV1, expressed as a percentage. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28|The FAS was used.|||percentage of predicted FEV1||Standard Deviation|Mean
1312382|NCT02508207|Primary|Absolute Change From Baseline in Mucociliary Clearance (MCC) at Day 28|MCC was assessed using an imaging technique that enables the tracking of mucus within the airways. MCC was expressed as the percentage of whole-lung clearance through 60 minutes at Baseline and Day 28.|Baseline, Day 28|The Full Analysis Set (FAS) included all randomized participants who carry the relevant cystic fibrosis transmembrane conductance regulator (CFTR) allele and received at least 1 dose of study drug.|||percentage of whole-lung clearance||Standard Deviation|Mean
1312383|NCT02508194|Secondary|Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)|An serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and approximately 1 year follow up that were absent before treatment or that worsened relative to pretreatment state. An adverse event of special interest was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. The Season 1 was approximately 1 year.|Day 1 (post-dose) through end of Season 1 (approximately 1 year)|ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.|||Participants|||Count of Participants
1312384|NCT02508194|Secondary|Number of Participants With Treatment-Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (post-dose) through Day 29|ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.|||Participants|||Count of Participants
1312385|NCT02508194|Secondary|Number of Participants With Any Solicited Symptoms|Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever >= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7.|Day 1 (post-dose) through Day 7|ATP: Participants who received any dose of investigational product (IP). Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.|||Participants|||Count of Participants
1312386|NCT02508194|Secondary|Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA|Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
1312387|NCT02508194|Secondary|Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA|"Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
1312388|NCT02508194|Secondary|Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)|"Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC was to be calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
1312389|NCT02508194|Secondary|Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay|Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
1312390|NCT02508194|Secondary|Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay|"Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
1312391|NCT02508194|Secondary|Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay|"Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
1312392|NCT02508194|Secondary|Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody|Seroresponse was defined as a >= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. The Season 1 was approximately 1 year.|Day 29 of Season 1|Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.|||Percentage of Participants|||Number
1312393|NCT02508194|Secondary|Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine|"Geometric mean fold change was calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year."|Day 29 of Season 1|Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.|||Fold Change||95% Confidence Interval|Geometric Mean
1312394|NCT02508194|Secondary|Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine|"GMT was calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year."|Day 1 (post-dose) and Day 29 of Season 1|Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1312395|NCT02508194|Secondary|Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay|Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a greater than or equal to (>=) 3-fold rise of serum antibodies against RSV from baseline. The Season 1 was approximately 1 year.|Day 29 and End of Season 1 (approximately 1 year)|Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.|||Percentage of Participants||95% Confidence Interval|Number
1312396|NCT02508194|Secondary|Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay|"Anti-F IgG antibodies concentration was determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold change from baseline for each participant. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.|||Fold Change||95% Confidence Interval|Geometric Mean
1312397|NCT02508194|Secondary|Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|"Anti-F IgG antibodies concentration were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. The Season 1 was approximately 1 year."|Day 1, Day 29, and End of Season 1 (approximately 1 year)|Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.|||Fragment antigen-binding (F AB) unit/mL||95% Confidence Interval|Geometric Mean
1312398|NCT02508194|Secondary|Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1|Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.|Day 14 after dosing through end of surveillance period (approximately 7 months)|Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.|||Percentage of Participants|||Number
1312399|NCT02508194|Primary|Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1|ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV‑related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.|Day 14 after dosing through end of surveillance period (approximately 7 months)|Per-protocol population: All participants in the as-treated population (ATP) who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.|||Percentage of Participants|||Number
1312400|NCT02508103|Primary|Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI)|"During fMRI scanning, the investigators will assess the effects of intranasal oxytocin (vs. placebo) on amygdala response to cognitive-emotional processing task (Hariri et al., 2006) during the late luteal phase of two consecutive menstrual cycles. Amygdala reactivity was assessed by extracting a contrast of parameter estimate (COPE) for each region (left and right amygdala). Regions were defined using binarized Harvard-Oxford Subcortical Atlas masks. The parameter estimate was the average estimate of all voxels in each region for the task contrast of viewing Faces vs. Shapes. We used neuroimaging software package FSL to calculate and extract these parameter estimates."|1 hour of scanning during the late luteal phase of two consecutive menstrual cycles||||parameter estimate||Standard Deviation|Mean
1312440|NCT02506881|Primary|AUEC|"Area Under Effect Curve (AUEC) of reticulocytes count from the Moment of Drug Administration Until 504 hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for pharmacokinetics analysis included patients who received at least one study drug injection.|||(reticulocytes * 10^9/l)*hour||Inter-Quartile Range|Median
1312401|NCT02508103|Primary|Change in Premenstrual Symptom Severity|The investigators will analyze premenstrual symptom severity ratings during the late luteal phase of two consecutive menstrual cycles to assess the effects of intranasal oxytocin (vs. placebo) on premenstrual symptom severity. Daily premenstrual symptoms were measured using the Daily Record of Severity of Problems (DRSP; Endicott et al., 2006). Across 24 items representing emotional, physical, and behavioral symptoms, participants indicated “the degree to which the problems have been experienced today”: 1—Not at all, 2—Minimal, 3—Mild, 4—Moderate, 5—Severe, or 6—Extreme. For each participant, we calculated a total score by summing all 24 items. We then calculated a mean total score for each condition by averaging all participants total scores in a given condition. Higher scores represent greater symptoms. Range of total score is 24 to 144.|During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment)||||units on a scale||Standard Deviation|Mean
1312402|NCT02508077|Primary|4-month Progression-free Survival (PFS) Rate|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Will be estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including baseline sum), or a measurable increase in a non-target lesion, or the appearance of new lesions.|At 4 months||||percentage of participants|||Number
1312403|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24.|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Week 12 and 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.|||Percentage||95% Confidence Interval|Number
1312404|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire.|||Percentage||95% Confidence Interval|Number
1312405|NCT02507752|Secondary|Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular domain of SF-36.|||scores on a scale||Standard Error|Mean
1312406|NCT02507752|Secondary|Change in SF-36 Physical and Mental Component Scores From Screening to Week 12|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular component of SF-36.|||scores on a scale||Standard Error|Mean
1312407|NCT02507752|Secondary|Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24|Visual Analogue Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from Screening=scores at observation minus score at Screening. An increase in score from Screening represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. The change in pain scale was analyzed for the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
1312441|NCT02506881|Primary|Cmax|"Maximal concentration of darbepoetin alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis included patients who received at least one study drug injection.|||pg/ml||Inter-Quartile Range|Median
1312449|NCT02506660|Primary|Nerve Block Duration|Time at which the pain relief from the block has completely worn off|Postoperative day 2+||||Hours||Inter-Quartile Range|Median
1312408|NCT02507752|Secondary|Change in HAQ Score From Screening to Weeks 12 and 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The number of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
1312409|NCT02507752|Secondary|Mean Change From Baseline in Patient Global Assessment (100 mm VAS)|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = scores at observation minus score at Baseline. An increase in score from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
1312410|NCT02507752|Secondary|Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
1312411|NCT02507752|Secondary|Mean Change From Baseline in Tender Joint Count (TJC)|A tender joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It is associated more with the level of pain.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Number of tender joints||Standard Error|Mean
1312412|NCT02507752|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC)|A swollen joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It reflects the amount of inflamed synovial tissue.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Number of swollen joints||Standard Error|Mean
1312413|NCT02507752|Secondary|Mean Change From Baseline in C-reactive Protein (CRP).|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||mg/L||Standard Error|Mean
1312414|NCT02507752|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate is an acute phase reactant and a measure of inflammation.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||mm/hr||Standard Error|Mean
1312415|NCT02507752|Secondary|Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.|An infusion reaction is defined as an adverse event that occurs during infusion or within 24 hours after infusion of Rituximab. All infectious events, whether considered related or not to Rituximab, were collected for the safety analysis of the study. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Up to 24 Weeks|The ITT population included all screened participants who answered at least one SF-36 questionnaire.|||participants|||Number
1312416|NCT02507752|Primary|Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline and Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.|||scores on a scale||Standard Error|Mean
1312442|NCT02506881|Primary|AUC|Area Under Concentration-time Curve (AUC) of Darbepoetin Alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) Hours and to Infinity(AUC(0-336)/AUC(0-72) and AUC(0-∞) Respectively Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||(pg/ml)*hour||Inter-Quartile Range|Median
1312443|NCT02506660|Secondary|% of Participants Who Guessed the Correct Group|Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group|Postoperative day 7-10||||% of participants||95% Confidence Interval|Number
1312417|NCT02507752|Primary|Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire.|||Percentage||95% Confidence Interval|Number
1312418|NCT02507388|Secondary|Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status (Test)|A positive ADA status is defined as induced ADA status with ADA negative at predose and with a post-dose titer value increase of 2 or more dilutions at any time point or boosted ADA status with ADA positive at predose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point.|Day 0 (predose), Day 28, Day 84|PK analysis set|||percentage of participants|||Number
1312419|NCT02507388|Primary|Concentration of RTH258 Obtained 24 Hours Post Day 56 Injection [C24hr (ng/mL)]|Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 57|PK analysis set|||ng/mL||Standard Deviation|Mean
1312420|NCT02507388|Primary|Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)]|Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 1|PK analysis set|||ng/mL||Standard Deviation|Mean
1312421|NCT02507388|Primary|Elimination Half-life in Serum [t1/2 (h)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set. Harmonic mean and jackknife estimate of the standard deviation are presented.|||hours||Standard Deviation|Mean
1312422|NCT02507388|Primary|Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set|||ng*h/mL||Standard Deviation|Mean
1312423|NCT02507388|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set|||ng*h/mL||Standard Deviation|Mean
1312424|NCT02507388|Primary|Time to Reach Maximum Analyte Serum Concentration [Tmax (h)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set|||hours||Standard Deviation|Mean
1312425|NCT02507388|Primary|Maximum Analyte Serum Concentration [Cmax (ng/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|The PK analysis set included all subjects who received an intravitreal (IVT) injection with evaluable PK data and with no major protocol deviations that could have had an impact on the PK analysis.|||ng/mL||Standard Deviation|Mean
1312426|NCT02507375|Secondary|Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Steady-state volume of distribution of a drug is an estimate of drug distribution independent of elimination processes. It is most useful for predicting the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state (pseudo-equilibrium). It is a calculated measure.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset|||Liters||Standard Deviation|Mean
1312427|NCT02507375|Secondary|Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|A fundamental concept in pharmacokinetics is drug clearance (CL), that is, elimination of drugs from the body. The clearance is simply the ratio of the dose to the area under the curve (AUC), so that the higher the AUC for a given dose, the lower the clearance. If a drug is administered by continuous infusion and a steady state is achieved, the clearance can be estimated from a single measurement of the plasma drug concentration.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK subset|||L/day||Standard Deviation|Mean
1312444|NCT02506660|Secondary|Block-related Complications||Postoperative day 7-10||||patients with block complications|||Number
1312445|NCT02506660|Secondary|Block Satisfaction|0-10 scale (0=not satisfied; 10=extremely satisfied)|Postoperative day 2, postoperative day 3||||units on a scale||Standard Deviation|Mean
1312446|NCT02506660|Secondary|Side Effects|"Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only.~For each symptom, severity is assessed by the question: “(If yes), how severe was it usually?” (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4)"|Postoperative day 2, postoperative day 3||||units on a scale||Standard Deviation|Mean
1312447|NCT02506660|Secondary|Opioid Consumption||Postoperative day 2, postoperative day 3||||mg||Standard Deviation|Mean
1312450|NCT02506309|Other Pre-specified|Number of Participants With Major Postoperative Complications||one year||||participants|||Number
1312428|NCT02507375|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC)|Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person’s bloodstream from time 0 (pre-dose) to a given time point (t) for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug’s blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL), which equates to mg.day/L. Bioavailability Extrapolated to Infinity [AUC (0-inf)] is a calculated measure of how much of the drug will ever reach the person’s bloodstream for the body to use. AUC (0-inf) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-inf).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset with appropriate data available|||mg*day/L||Standard Deviation|Mean
1312429|NCT02507375|Secondary|Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset with adequate data for this analysis|||days||Standard Deviation|Mean
1312430|NCT02507375|Secondary|Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|The time at which maximum concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, is reached (Tmax).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset|||days||Standard Deviation|Mean
1312431|NCT02507375|Secondary|Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, typically measured in nanograms/milliliter (ng/mL), reported as mg/L.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset, defined as all participants from either cohort with adequate data for performing PK analysis|||mg/L||Standard Deviation|Mean
1312432|NCT02507375|Secondary|Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6|Complete and partial responses were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A complete response was defined as the disappearance of all target and non-target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.|From baseline to the end of the study (up to 42 weeks)||||Percentage of participants|||Number
1312433|NCT02507375|Secondary|Percentage of Participants Classified as Responders|"Responders are participants who achieved either a complete response or a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 18 weeks|Full analysis set|||percentage of participants|||Number
1312434|NCT02507375|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|A DLT was defined as: Any non-hematological toxicity ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events, version 3.0, except for fever, chills, and flu-like symptoms, which occurred despite adequate participant management. The following Grade 1-3 toxicities were exempt: Grade 1-3 skin and/or epithelial toxicities consistent with erlotinib single agent therapy, unless they did not respond to treatment or dose reduction or interruption (Grade 4 skin and/or epithelial toxicities were considered to be a DLT); Grade 4 neutropenia occurring for > 7 days; febrile neutropenia which occurred despite adequate participant management; Grade 4 thrombocytopenia or any thrombocytopenia requiring platelet transfusion; and any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From baseline to end of the study (up to 42 weeks)||||Percentage of participants|||Number
1312435|NCT02507219|Primary|Dose-dependent Differences in the BOLD Response to fMRI Tasks in the Amygdala|Change in amygdala activation following administration of placebo, 200mg of ibuprofen or 600mg of ibuprofen|3-6 weeks|Scans that had average Euclidean norm of motion parameters less than 0.15 were included in the analyses.|||percent signal change||Standard Error|Mean
1312436|NCT02506881|Secondary|Cl|Serum clearance of of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||hours*kg||Inter-Quartile Range|Median
1312437|NCT02506881|Secondary|Tmax|Time to achieve maximum serum concentration of darbepoetin alfa after single sc of iv administration|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||hours||Inter-Quartile Range|Median
1312438|NCT02506881|Secondary|T1/2|Serum half-life of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||hours||Inter-Quartile Range|Median
1312439|NCT02506881|Primary|AC-Emax|"Maximum elevation of absolute reticulocyte count from the baseline from the Moment of Drug Administration Until 504 hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for analysis of pharmacodynamics included patients who received at least one study drug injection.|||reticulocytes * 10^9/l||Inter-Quartile Range|Median
1312451|NCT02506309|Other Pre-specified|Number of Participants With Major Perioperative Complications||one month||||participants|||Number
1327529|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine diphosphate|Baseline||||percentage of max platelet aggregation||Inter-Quartile Range|Median
1312452|NCT02506309|Secondary|Patient Global Impression of Improvement (PGI-I) Score|"Patient Global Impression of Improvement (PGI-I) score five years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians~Very much better~Much better~A little better~No change~A little worse~Much worse~Very much worse"|five years|||||||
1312453|NCT02506309|Secondary|Patient Global Impression of Improvement (PGI-I) Score|"Patient Global Impression of Improvement (PGI-I) score two years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians~Very much better~Much better~A little better~No change~A little worse~Much worse~Very much worse"|two years|||||||
1312454|NCT02506309|Secondary|Patient Global Impression of Improvement (PGI-I) Score|"Patient Global Impression of Improvement (PGI-I) score one year after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians~Very much better~Much better~A little better~No change~A little worse~Much worse~Very much worse"|one year||||units on PGI-I scale||Full Range|Mean
1312455|NCT02506309|Primary|Percentage of Participants With Negative Cough Stress Test (CST)|Negative cough stress test five years after incontinence surgery|five years|||||||
1312456|NCT02506309|Primary|Percentage of Participants With Negative Cough Stress Test (CST)|Negative cough stress test two years after incontinence surgery|two years|||||||
1312457|NCT02506309|Primary|Percentage of Participants With Negative Cough Stress Test (CST)|Negative cough stress test one year after incontinence surgery.|one year||||percentage of participants|||Number
1312458|NCT02506257|Other Pre-specified|Conjunctival Examination|Change from baseline conjunctival staining at Day 14. Staining with lissamine green was used. The density of staining was graded with the Oxford Score. Score range was between 0-15. An increase in the score after treatment represent a negative outcome|Baseline and Day 14||||scores on a scale||Standard Deviation|Mean
1312459|NCT02506257|Other Pre-specified|Ocular Surface Disease Index-OSDI|Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.|Baseline and Day 14||||scores on a scale||Standard Deviation|Mean
1312460|NCT02506257|Other Pre-specified|Visual Acuity|Change from baseline Visual acuity. Best corrected visual acuity was reported in decimal fraction. A decrease of visual acuity during treatment was considered a negative safety outcome.|Baseline and Day 14||||decimals||Standard Deviation|Mean
1312461|NCT02506257|Other Pre-specified|Systolic Blood Pressure|Change from baseline systolic blood pressure|Baseline and Day 14||||mmHg||Standard Deviation|Mean
1312462|NCT02506257|Secondary|Plasma Concentration of PHMB||Day14||||micrograms/ml||Standard Deviation|Mean
1312463|NCT02506257|Primary|Number of Subjects With Dose-limiting Adverse Events||up to 21 days from date of randomization||||participants|||Number
1312464|NCT02506101|Other Pre-specified|Number of Participants With Histological Change in Tissue Samples||24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
1312465|NCT02506101|Other Pre-specified|Response Stability Index||24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
1312466|NCT02506101|Secondary|Skindex-29 Questionnaire|Quality of life assessment|24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
1312467|NCT02506101|Secondary|Dermatology Life Quality Index (DLQI)|Quality of life assessment|24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
1312468|NCT02506101|Primary|Vitiligo Area Scoring Index (VASI)|VASI scores of treated versus untreated symmetrical body sites.The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites [Hand Units] ´ [Residual depigmentation].|24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
1312469|NCT02505334|Secondary|Change in Pulse|Change from baseline (week 0) in pulse was evaluated after 26 weeks of treatment.|Week 0, Week 26|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. Missing values were imputed using the LOCF method.|||Beats/minute||Standard Deviation|Mean
1312470|NCT02505334|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition|"ADA classification of hypoglycaemia:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.~Asymptomatic: PG level ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG level >3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 + 7 days). Hence, the following shown ‘Time Frame’ should be read as ‘Weeks 0-26 + 7 days’."|Weeks 0-26|Safety analysis set, which included all subjects receiving at least one dose of liraglutide.|||Episodes|||Number
1312488|NCT02505334|Secondary|Change in Blood Pressure (Systolic and Diastolic)|Change from baseline (week 0) in blood pressure (systolic and diastolic) was evaluated after 26 weeks of treatment.|Week 0, Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mmHg||Standard Deviation|Mean
1312471|NCT02505334|Secondary|Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during 26 weeks of treatment. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 + 7 days). Hence, the following shown ‘Time Frame’ should be read as ‘Weeks 0-26 + 7 days’.|Weeks 0-26|Safety analysis set, which included all subjects receiving at least one dose of liraglutide.|||Episodes|||Number
1312472|NCT02505334|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during 26 weeks of treatment. Severe or BG confirmed symptomatic hypoglycaemia: An episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. ADA definition of severe hypoglycaemia: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). Hence, the following shown ‘Time Frame’ should be read as ‘Weeks 0-26 + 7 days’.|Week 0-26|Safety analysis set, which included all subjects receiving at least one dose of liraglutide.|||Episodes|||Number
1312473|NCT02505334|Secondary|Number of Treatment Emergent Adverse Events (Weeks 0-52)|TEAEs were evaluated during 52 weeks of treatment. A TEAE for the 52-week treatment period was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown ‘Time Frame’ should be read as ‘Weeks 0-52 + 7 days’.|Weeks 0-52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for this outcome measure, as the subjects in this treatment arm received treatment for 26 weeks (main period).|||Events|||Number
1312474|NCT02505334|Secondary|Number of Treatment Emergent Adverse Events (Weeks 0-26)|Treatment emergent adverse events (TEAEs) were evaluated during 26 weeks of treatment. A TEAE for the 26-week treatment period was defined as an event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). Hence, the following shown ‘Time Frame’ should be read as ‘Weeks 0-26 + 7 days’.|Weeks 0-26|Safety analysis set, which included all subjects receiving at least one dose of liraglutide.|||Events|||Number
1312475|NCT02505334|Secondary|Free Fatty Acids|Free fatty acids were evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1312476|NCT02505334|Secondary|Triglycerides|Triglycerides were evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1312477|NCT02505334|Secondary|Very Low Density Lipoprotein (VLDL) Cholesterol|VLDL was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1312478|NCT02505334|Secondary|High Density Lipoprotein (HDL) Cholesterol|HDL was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1312479|NCT02505334|Secondary|Low Density Lipoprotein (LDL) Cholesterol|LDL was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1312480|NCT02505334|Secondary|Total Cholesterol|Total cholesterol was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1312481|NCT02505334|Secondary|Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)|HOMA-IR was evaluated after 26 weeks of treatment. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||HOMA-IR score||Geometric Coefficient of Variation|Geometric Mean
1312482|NCT02505334|Secondary|Homeostasis Model Assessment of Beta-cell Function (HOMA-B)|HOMA-B was evaluated after 26 weeks of treatment. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)].|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||Percentage (%) of beta-cell function||Geometric Coefficient of Variation|Geometric Mean
1312483|NCT02505334|Secondary|Proinsulin/Insulin|Proinsulin/insulin was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||Percentage (%) of proinsulin/insulin||Geometric Coefficient of Variation|Geometric Mean
1312484|NCT02505334|Secondary|Proinsulin|Proinsulin was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1312485|NCT02505334|Secondary|Fasting Glucagon|Fasting glucagon was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1312486|NCT02505334|Secondary|Fasting Insulin|Fasting insulin was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1312487|NCT02505334|Secondary|Fasting C-peptide|Fasting C-peptide was evaluated after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1312490|NCT02505334|Secondary|Change in Body Weight (Week 52)|Change from baseline (week 0) in body weight was evaluated after 52 weeks of treatment.|Week 0, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for this outcome measure, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Kilogram (kg)||Standard Deviation|Mean
1312491|NCT02505334|Secondary|Change in Body Weight (Week 26)|Change from baseline (week 0) in body weight was evaluated after 26 weeks of treatment.|Week 0, Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||Kilogram (kg)||Standard Deviation|Mean
1312492|NCT02505334|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated after 26 weeks of treatment.|Week 0, Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||Centimeter (cm)||Standard Deviation|Mean
1312493|NCT02505334|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated after 26 weeks of treatment.|Week 0, Week 26|FAS, which included all randomised subjects. Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
1312494|NCT02505334|Secondary|Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)|Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks of treatment.|Week 0, Week 26|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis. Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
1312495|NCT02505334|Secondary|Change in SMBG 7-point Profile: Mean of 7-point Profile|Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks of treatment.|Week 0, Week 26|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis. Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
1312496|NCT02505334|Secondary|Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)|"Reported results are 7-point SMBG values at week 0 and week 26. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:~Before breakfast.~90 minutes after start of breakfast.~Before lunch.~90 minutes after start of lunch.~Before dinner.~90 minutes after start of dinner.~At bedtime."|Week 0, Week 26|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
1312497|NCT02505334|Secondary|Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|Reported results are subjects with HbA1c <7.0% after 26 weeks of treatment without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per American Diabetes Association (ADA) classification or BG confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26+7 days). Hence, the following shown ‘Time Frame’ should be read as ‘Week 26+7 days’|Week 26|FAS, which included all randomised subjects. Missing HbA1c values were imputed using the LOCF method.|||Participants|||Count of Participants
1312498|NCT02505334|Secondary|Responder for HbA1c Below 7.0% Without Weight Gain|Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing HbA1c values were imputed using the LOCF method.|||Participants|||Count of Participants
1312499|NCT02505334|Secondary|Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing HbA1c values were imputed using the LOCF method.|||Participants|||Count of Participants
1312500|NCT02505334|Secondary|Responder for HbA1c Below 7.0% (53 mmol/Mol) (Week 52)|Reported results are number of subjects who achieved HbA1c target below 7.0% after 52 weeks of treatment.|Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for this outcome measure, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Participants|||Count of Participants
1312501|NCT02505334|Secondary|Responder for HbA1c Below 7.0% (53 mmol/Mol) (Week 26)|Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks of treatment.|Week 26|FAS, which included all randomised subjects. Missing HbA1c values were imputed using the LOCF method.|||Participants|||Count of Participants
1312502|NCT02505334|Secondary|Change in HbA1c (Week 52)|Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.|Week 0, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for this outcome measure, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Percentage (%) of HbA1c||Standard Deviation|Mean
1312503|NCT02505334|Primary|Change in Glycosylated Haemoglobin (HbA1c) (Week 26)|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.|Week 0, Week 26|FAS, which included all randomised subjects. Missing values were imputed using the last observation carried forward (LOCF) method.|||Percentage (%) of HbA1c||Standard Error|Least Squares Mean
1312519|NCT02504294|Secondary|Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment||Baseline (8 Weeks prior to randomization), Week 17 up to Week 24|"FAS included all participants who received at least 1 dose of study medication after randomization in to the study. Here, N signifies number of participants who were evaluable for this outcome measure."|||Units per week||Standard Error|Least Squares Mean
1312504|NCT02504931|Secondary|PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)|"The PCL is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study.~The survey has 20 questions scored as:~0=Not at all~A little bit~Moderately~Quite a bit~Extremely~Interpretation of the PCL should be made by a clinician. The total symptom severity score is obtained by summing the scores for each of the 20 items to give a total of 1-80 points. The lower the score, the less severe the symptoms of PTSD, the higher the score, the more severe the symptoms."|12 weeks of treatment||||Units on a scale||Standard Deviation|Mean
1312505|NCT02504931|Primary|Percent Heavy Drinking Days|Number of heavy drinking days in a 12 week period is reported by subjects and the percentage is calculated.|12 weeks||||percentage of days||Standard Deviation|Mean
1312506|NCT02504775|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||Hours (h)||Standard Deviation|Mean
1312507|NCT02504775|Primary|Maximum Plasma Concentration (Cmax)|Cmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||micogram per mililitre (μg/mL)||Standard Deviation|Mean
1312508|NCT02504775|Primary|Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]|AUC(0-inf) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||h*μg/mL||Standard Deviation|Mean
1312509|NCT02504775|Primary|Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]|AUC(0-t) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 hours (h) after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||hours*microgram/millilitre (h*μg/mL)||Standard Deviation|Mean
1312510|NCT02504723|Secondary|All Adverse Effects|All adverse effects during the study period|Within 6 years||||Participants|||Count of Participants
1312511|NCT02504723|Secondary|All Cause Mortality or Liver Transplantation|All cause mortality or liver transplantation during the study period|Within 6 years||||Participants|||Count of Participants
1312512|NCT02504723|Secondary|All Upper Gastrointestinal Bleeding|All upper gastrointestinal bleeding during the follow-up period|Within 6 years||||Participants|||Count of Participants
1312513|NCT02504723|Primary|Rebleeding From Gastric Varices|Rebleeding from gastric varices during the follow-up period|Within 6 years||||Participants|||Count of Participants
1312514|NCT02504541|Primary|Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism|"Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population.~Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)"|26 weeks||||Participants|||Count of Participants
1312515|NCT02504502|Primary|Satisfaction With Genomic Test Report|3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.|3 months after receipt of enhanced report|"parents who opened the enhanced report per electronic confirmation. For Clinical care then enhanced report N=4 CV; 2NCV - these 2 NCV parents did not answer the survey questions about the report (missing). For routine care with enhanced report first N=9 NCV."|||Participants|||Count of Participants
1312516|NCT02504320|Primary|Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat|AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1312517|NCT02504320|Primary|Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat|AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1312518|NCT02504320|Primary|Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1312565|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||percentage||Inter-Quartile Range|Median
1312520|NCT02504294|Primary|Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)||Week 17 up to Week 24|"FAS included all participants who received at least 1 dose of study medication after randomization into the study. Here, Number of participants analyzed (N) signifies those number of participants who were evaluable for this outcome measure."|||Percentage of Weeks||95% Confidence Interval|Number
1312521|NCT02504099|Secondary|Percentage of Participants With Recurrent HCV Infection Post Liver Transplant|The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.|from liver transplant to 24 weeks post-treatment (up to 48 weeks)|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
1312522|NCT02504099|Secondary|Percentage of Participants With Long Term Clinical Outcomes|The percentage of participants with long term clinical outcomes (de novo hepatocellular carcinoma (HCC) lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above) from first dose of study drug through 24 weeks post-treatment follow-up.|up to 48 weeks|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
1312523|NCT02504099|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
1312524|NCT02504099|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ throughout treatment with at least 6 weeks of treatment.|Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 12-week treatment)|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
1312525|NCT02504099|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after flanking imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
1312526|NCT02504073|Primary|Number of Hypotheses Observed|This outcome is a result of the third part of the questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified and categorised all the listed hypotheses from question number three of the questionnaire. After that the use frequency of each item was analysed globally and for each patient.|up to 2 months||||Number of different hypotheses|||Number
1312527|NCT02504073|Primary|Number of Main Problems Observed|This outcome is a result of the second part of the Questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified the main statements from the sentences written. Items were afterwards categorised. Finally the frequency of each item was analysed globally and for each patient.|up to 2 months||||number of different main problems|||Number
1312528|NCT02504073|Primary|Number of Gait Abnormalities Observed|"The questionnaire will be the basis of this study as it will be the basis for open coding. It is handed out to 54 observers (=physiotherapists) and will be filled in 6 times (for 6 patient videos).~The questionnaire consists of 3 main questions:~what gait abnormalities do you see?~What do you consider the main problem (1 sentence)~what is your hypothesis (max. 3) The question one delivers different items (each new observation is a new item) that were determined patient by patient and rater by rater by three independent researchers. They were then listed and categorised by consensus. Finally, the frequency of each item was analysed globally and for each patient."|up to 2 months||||number of different gait abnormalities|||Number
1312529|NCT02503982|Primary|Area Under the Curve (AUC)|Valganciclovir area under the curve (AUC) calculated with the trapezoidal method using drug levels measured at 2, 5 and 10 h, and extrapolated beyond the 10 hour time point to arrive at a 24-hour curve.|drug levels measured at 2, 5 and 10 h following administration of the dose on day 4 creating a 24 hours curve||||mcg∙h/mL||Inter-Quartile Range|Median
1312530|NCT02503865|Secondary|Immunoassay Cortisole in Blood|Immunoassay Cortisole in the blood (nmole/L) was measured|up to 12 weeks||||nmol/L||Standard Error|Mean
1312531|NCT02503865|Secondary|Immunoassay Hormones in Blood|Immunoassay Insulin in the blood (in nU/L) was investigated|up to 12 weeks||||nU/L||Standard Error|Mean
1312532|NCT02503865|Secondary|Lipid Profile|Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured|up to 12 weeks||||mmole/L||Standard Error|Mean
1312533|NCT02503865|Primary|Systolic/ Diastolic Blood Pressures (mm Hg)|Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery|up to 12 weeks||||mm Hg||Standard Error|Mean
1312534|NCT02503865|Primary|Blood Glucose Level|Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.|up to 12 weeks||||mmole/L||Standard Error|Mean
1312535|NCT02503787|Other Pre-specified|Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average leg pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation||||units on a scale||Standard Deviation|Mean
1312536|NCT02503787|Other Pre-specified|Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average back pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation||||units on a scale||Standard Deviation|Mean
1312537|NCT02503787|Secondary|Patient Global Impression of Change|Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).|From baseline to 3 months post device activation||||Participants|||Count of Participants
1312538|NCT02503787|Primary|Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation||||units on a scale||Standard Deviation|Mean
1312539|NCT02503254|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population: all randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment.~However, due to sample issues such as clotting, COHb assessment results could not be generated for some of the subjects."|||percentage of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
1312540|NCT02503254|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1312541|NCT02503254|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."|||ng/mg creat||95% Confidence Interval|Least Squares Mean
1312542|NCT02503254|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1312543|NCT02503215|Secondary|Change in Fluid Distribution From Baseline|Segmental and total body water will be non-invasively assessed before sleeping and after awakening by a bioimpedance device (InBody S10 Analyser™, Biospace, South Korea), which will provide information regarding nighttime fluid shift at baseline and after compression stocking use. The amount of water, expressed in liters, is assessed in both extra and intracellular components.|1 week|"Volume distribution evaluated by bioimpedance analysis evaluated fluid shift from the legs at baseline and after wearing compression stockings. The amount overnight fluid that moved rostrally from the legs is depicted below (results expressed as mean ± standard deviation):~Baseline: 571.4 ± 389.6 ml~Compression stockings: 517.9 ± 452.2 ml"|||mililiters||Standard Deviation|Mean
1312544|NCT02503215|Secondary|Change of Heart Rate Variability Change From Baseline|Electrocardiogram performed during polysomnography examination will be downloaded to a specific software for heart rate variability assessment (Kubius HRV™, University of Eastern Finland, Finland), which provides spectral assessment of heart rate variability in its both components: low frequency (LF) and high frequency (HF). Patients who present higher LF/HF during the night compared to the beggining of the polysomnography exam have, by definition, increased sympathetic activity during the night. Such evaluation will be accessed in both baseline and after compression stockings use.|1 week|Overnight increase in LF/HF ratio at baseline: 11/12 patients (92%) Overnight increase in LF/HF ratio after compression stockings use: 7/12 patients (58%)|||percentage of participants|||Number
1312545|NCT02503215|Primary|Change of Obstructive Apnea Severity Index Score From Baseline|"Apnea/Hypopnea index (AIH) was assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use. The observed results are expressed as median and interquartile range (25,75 percentiles):~AIH at baseline: 20.8 (14.2; 39.6) events/hour;~AIH after compression stockings use: 16.7 (3.5; 28.9) events/hour"|1 week|Apnea/Hypopnea Index|||events/hour||Inter-Quartile Range|Median
1312546|NCT02503085|Secondary|Number of Subjects With Adverse Events (AEs).|"Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied.~Mild = AE did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.~Relationship to Investigational Medicinal Products (IMP)~Unassessable/Unclassified = Insufficient information to be able to make an assessment.~Conditional/ Unclassified = Insufficient information to make an assessment at present.~Unrelated = No possibility that AE was caused by IMP. Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP. Certain = AE was definitely caused by IMP."|Up to follow-up day 7|Safety population|||Participants|||Count of Participants
1312547|NCT02503085|Secondary|Plasma Concentration at Each Planned Nominal Time-point (Cn)|Cn was derived using linear interpolation from the 2 samples taken either side of the nominal time where there was a sampling time deviation. For concentrations that were missing due to blood samples not being taken Cn was not derived.|Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||ng/mL||Standard Deviation|Mean
1312566|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra||||percentage||Inter-Quartile Range|Median
1312548|NCT02503085|Secondary|Plasma Concentration Half-life (T1/2)|Terminal elimination half-life (T1/2) = ln(2)/Kel|Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min||Standard Deviation|Mean
1312549|NCT02503085|Secondary|Time to Cmax (Tmax)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min||Standard Deviation|Mean
1312550|NCT02503085|Secondary|Ratio of AUC0-t/AUC0-inf (AUCR)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||Ratio||Standard Deviation|Mean
1312551|NCT02503085|Secondary|AUC From Administration to Infinity (AUC0-inf)|AUC0-inf = AUC0-t + (Ct/Kel), where Ct was the last quantifiable concentration at time t.|Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min*ng/mL||Standard Deviation|Mean
1312552|NCT02503085|Secondary|Elimination Rate Constant (Kel)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||1/min||Standard Deviation|Mean
1312553|NCT02503085|Primary|Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min*ng/mL||Standard Deviation|Mean
1312554|NCT02503085|Primary|Maximum Plasma Concentration (Cmax)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||ng/mL||Standard Deviation|Mean
1312555|NCT02502734|Secondary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Number of participants with AEs and SAEs have been presented. Two participants randomized to Sequence 1 (Placebo/FF), were treated with placebo in Period 1; however, neither received FF in Period 2, due to premature withdrawal.|From the start of study treatment until follow-up (assessed up to 54 days)|ITT Population|||Participants|||Number
1312556|NCT02502734|Primary|Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.|Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medications that may affect short term growth, prior to randomization and during the study; protocol deviations defined in exclusion criteria for growth population. ITT Population consists of all randomized participants who received at least one dose of study drug.|Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.|Growth Population|||millimeter per week||Standard Deviation|Least Squares Mean
1312557|NCT02502526|Secondary|Balanced Salt Solution (BSS) Fluid Used|BSS Fluid was measured by weighing the BSS bag after priming. BSS Used is Incision Leakage Fluid plus Aspiration Fluid Used. A reduction in BSS fluid used implies less induced trauma to tissues. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|ITT with non-missing data|||milliliters (ml)||Standard Deviation|Mean
1312558|NCT02502526|Secondary|Cumulative Dissipated Energy (CDE)|Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|ITT with non-missing data|||percent-seconds||Standard Deviation|Mean
1312559|NCT02502526|Primary|Cumulative Dissipated Energy (CDE)|Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK.|Day 0 (operative day)|ITT with non-missing data|||percent-seconds||Standard Deviation|Mean
1312560|NCT02502487|Secondary|Breath Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope||||times per minute||Standard Deviation|Mean
1312561|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||times per minute||Standard Deviation|Mean
1312562|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar Urthra||||times per minute||Standard Deviation|Mean
1312563|NCT02502487|Secondary|Breath Rate Before Gel Administration||before gel administration||||times per minute||Standard Deviation|Mean
1312564|NCT02502487|Secondary|Oxygen Saturation by Pulse After Withdrawal of Cystoscope||after withdrawal of cystoscope||||percentage||Inter-Quartile Range|Median
1312576|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|after withdrawal of cystoscope||||units on a scale||Inter-Quartile Range|Median
1312577|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of prostate and bladder||||units on a scale||Inter-Quartile Range|Median
1312578|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of penile and bulbar urethra||||units on a scale||Inter-Quartile Range|Median
1312579|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|before gel administration||||units on a scale||Inter-Quartile Range|Median
1312580|NCT02502487|Primary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients’ pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of external sphincter||||units on a scale||Inter-Quartile Range|Median
1312581|NCT02502149|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) at 15K Manufacturing Scale|An SAE is any untoward medical occurrence that at any dose: results in death or in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. All major surgeries will be reported as SAEs. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the SAE definition. Number of participants with TESAEs were summarized overall.|Approximately 43 weeks|The population analyzed included all participants who received at least 1 dose of rFVIIIFc at 15k manufacturing scale.|||Participants|||Count of Participants
1312582|NCT02502149|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) at 15K Manufacturing Scale|An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of Participants with TEAEs were summarized overall.|Approximately 43 weeks|The population analyzed included all participants who received at least 1 dose of rFVIIIFc at 15k manufacturing scale.|||Participants|||Count of Participants
1312583|NCT02502149|Secondary|Development of Inhibitors as Measured by the Nijmegen-modified Bethesda Assay|An inhibitor test result greater than or equal to (>=)0.6 Bethesda units [BU]/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. The test was performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the percentage of participants with a confirmed inhibitor was calculated using the Clopper-Pearson method for a binomial proportion. Percentage of participants with confirmed inhibitor development was summarized overall.|At screening and predose on Day 1, 13 and 26 weeks after PK2 injection or at Early Termination (Approximately 43 weeks)|The population analyzed included all participants who received at least 1 dose of rFVIIIFc.|||percentage of participants||95% Confidence Interval|Number
1312584|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
1312585|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
1312617|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1312586|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||milliliter per hour per kilogram(mL/h/kg||95% Confidence Interval|Geometric Mean
1312587|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312588|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
1312589|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1312590|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1312591|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||hours (h)||95% Confidence Interval|Geometric Mean
1312592|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/kg||95% Confidence Interval|Geometric Mean
1312593|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1312594|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312595|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
1312596|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1312597|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1312598|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
1312599|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured the Two-stage Chromogenic Assay for PK2 and PK3|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
1312600|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1312601|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312602|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
1312603|NCT02502149|Secondary|Incremental Recovery (IR) as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1312604|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1312605|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||hours (h)||95% Confidence Interval|Geometric Mean
1312606|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||mL/kg||95% Confidence Interval|Geometric Mean
1312607|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1312608|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312609|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU/dL||95% Confidence Interval|Geometric Mean
1312610|NCT02502149|Secondary|Incremental Recovery (IR) as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1312611|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1312612|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
1312613|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
1312614|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1312615|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312616|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
1327530|NCT02140372|Primary|Monocyte Platelet Aggregate: Baseline||Baseline||||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
1312618|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1312619|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||hours (h)||95% Confidence Interval|Geometric Mean
1312620|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/kg||95% Confidence Interval|Geometric Mean
1312621|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1312622|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312623|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
1312624|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1312625|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1312626|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
1312627|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
1312662|NCT02500706|Secondary|Change From Baseline in Haemoglobin 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haemoglobin measurement.|||mmol/L||Standard Deviation|Mean
1312628|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1312629|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312630|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
1312631|NCT02502149|Secondary|Incremental Recovery (IR) as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1312632|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1312633|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||hours (h)||95% Confidence Interval|Geometric Mean
1312634|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||milliliter per kilogram (mL/kg)||95% Confidence Interval|Geometric Mean
1312635|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||milliliter per hour per kilogram(mL/h/kg||95% Confidence Interval|Geometric Mean
1312636|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Half-life is time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||Hours (h)||95% Confidence Interval|Geometric Mean
1312663|NCT02500706|Secondary|Change From Baseline in Haematocrit 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haematocrit measurement.|||percentage of red blood cells in blood||Standard Deviation|Mean
1312637|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||International units per deciliter (IU/dL||95% Confidence Interval|Geometric Mean
1312638|NCT02502149|Primary|Incremental Recovery (IR) as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS included all participants who have evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU/dL per IU/kg||90% Confidence Interval|Geometric Mean
1312639|NCT02502149|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage Activated Partial Thromboplastin Time (aPTT) Clotting Assay for Pharmacokinetic Assessment 1 (PK1) and Pharmacokinetic Assessment 2 (PK2)|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The Pharmacokinetic Analysis Set (PKAS) included all participants who have evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||International unit*hour per deciliter||90% Confidence Interval|Geometric Mean
1312640|NCT02501590|Primary|Normilized Muscle Activity|The maximal voluntary contraction (MVC) value for each muscle will be computed as the average of three peaks of the surface electromyography (sEMG) data, which differed by no more than 10% from one another. The mean root mean square (RMS) values of the sEMG data will be normalized by the MVC value for each muscle so that the value is presented by percentage.|day1||||% mvc||Inter-Quartile Range|Median
1312641|NCT02500836|Secondary|Immediate and Sustained Anesthetic Success for Cocaine HCl 10% Topical Solution|Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 10% Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 10% Cocaine HCl subjects who receive a diagnostic procedure or surgery).|One Day, Single office based diagnostic procedure or surgery|The analysis of secondary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug. The analysis of this secondary efficacy endpoint includes comparisons to the primary endpoint for the Placebo Topical Solution treatment group.|||proportion of participants||95% Confidence Interval|Number
1312642|NCT02500836|Primary|Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution|Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 4% Topical Solution or Placebo Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 4% Cocaine HCl subjects who receive a diagnostic procedure or surgery). Subjects with missing primary outcome data are marked as treatment failures in both treatment groups.|One Day, Single office based diagnostic procedure or surgery|The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug.|||proportion of participants||95% Confidence Interval|Number
1312643|NCT02500758|Secondary|"Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- Baseline and 3 Hours)."|Number of colony-forming units (CFU) sampled 3 hours after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate, using surgical gloves. After surgical scrubbing, drying and wearing surgical gloves, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.|3 hours||||CFU/ml||95% Confidence Interval|Mean
1312644|NCT02500758|Primary|"Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- Baseline and 5 Minutes)."|Number of colony-forming units (CFU) sampled up to 5 minutes after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate. After surgical scrubbing and drying, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.|5 minutes||||CFU/ml||95% Confidence Interval|Mean
1312645|NCT02500706|Secondary|Change From Baseline in Body Mass Index 26 Weeks After Randomisation|The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subject with data available for body mass index.|||kg/m^2||Standard Deviation|Mean
1312646|NCT02500706|Secondary|Change From Baseline in Body Weight 26 Weeks After Randomisation|The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subject with data available for body weight.|||kg||Standard Deviation|Mean
1313086|NCT02488980|Secondary|Time to a Single Positive Smear|Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. 95.5% confidence intervals were constructed for the relative risk.|24 Weeks||||Days||95% Confidence Interval|Median
1312647|NCT02500706|Secondary|Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation|Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).|Week 0, week 26|Analysis was based on the SAS. Number analysed=number of subjects with available data for anti-insulin aspart antibody.|||% B/T||Standard Deviation|Mean
1312648|NCT02500706|Secondary|Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation|Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for erythrocytes values.|||percentage of subjects|||Number
1312649|NCT02500706|Secondary|Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation|Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for protein values.|||percentage of subjects|||Number
1312650|NCT02500706|Secondary|Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation|Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for ketones values.|||percentage of subjects|||Number
1312651|NCT02500706|Secondary|Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for urinary albumin and creatinine measurement.|||mg/mmol||Standard Deviation|Mean
1312652|NCT02500706|Secondary|Change From Baseline in Total Protein 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total protein measurement.|||g/dL||Standard Deviation|Mean
1312653|NCT02500706|Secondary|Change From Baseline in Creatinine 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for creatinine measurement.|||umol/L||Standard Deviation|Mean
1312654|NCT02500706|Secondary|Change From Baseline in Potassium 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for potassium measurement.|||mmol/L||Standard Deviation|Mean
1312655|NCT02500706|Secondary|Change From Baseline in Total Bilirubin 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total bilirubin measurement.|||umol/L||Standard Deviation|Mean
1312656|NCT02500706|Secondary|Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for aspartate aminotransferase measurement.|||U/L||Standard Deviation|Mean
1312657|NCT02500706|Secondary|Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alkaline phosphatase measurement.|||U/L||Standard Deviation|Mean
1312658|NCT02500706|Secondary|Change From Baseline in Albumin 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for albumin measurement.|||g/dL||Standard Deviation|Mean
1312659|NCT02500706|Secondary|Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alanine aminotransferase measurement.|||U/L||Standard Deviation|Mean
1312660|NCT02500706|Secondary|Change From Baseline in Thrombocytes 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for thrombocytes measurement.|||Number of thrombocytes 10^9/L||Standard Deviation|Mean
1312661|NCT02500706|Secondary|Change From Baseline in Leukocytes 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for leukocytes measurement.|||Number of leukocytes 10^9/L||Standard Deviation|Mean
1327531|NCT02140164|Secondary|Number of Severe Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.|||adverse events|||Number
1312664|NCT02500706|Secondary|Change From Baseline in Erythrocytes 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for erythrocytes measurement.|||number of erythrocytes 10^12/L||Standard Deviation|Mean
1312665|NCT02500706|Secondary|Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation|The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for fundoscopy/fundus photography at specified timepoints.|||percentage of subjects|||Number
1312666|NCT02500706|Secondary|Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation|The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for electrocardiogram at specified timepoints.|||percentage of subjects|||Number
1312667|NCT02500706|Secondary|Change From Baseline in Pulse 26 Weeks After Randomisation|Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subjects with available data for pulse.|||beats/minute||Standard Deviation|Mean
1312668|NCT02500706|Secondary|Change From Baseline in Blood Pressure 26 Weeks After Randomisation|Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subjects with available data for blood pressure|||mmHg||Standard Deviation|Mean
1312669|NCT02500706|Secondary|Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)|The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal’, ‘abnormal, not clinically significant' (Abn, NCS) or ‘abnormal, clinically significant’ (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for physical examinations at specified timepoints.|||percentage of subjects|||Number
1312670|NCT02500706|Secondary|Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal|"ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.~NN Classification:~Severe: same as per ADA classification~Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia~BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes related to meals."|Week 0 to week 26 (+1 day)|Analysis was based on SAS.|||hypoglycaemic episodes|||Number
1312671|NCT02500706|Secondary|Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 – Inclusive)|"ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.~NN Classification:~Severe: same as per ADA classification~Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia~BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive."|Week 0 to week 26 (+1 day)|Analysis was based on SAS.|||hypoglycaemic episodes|||Number
1312672|NCT02500706|Secondary|Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall|"ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.~NN Classification:~Severe:same as per ADA classification~Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period."|Week 0 to week 26 (+1 day)|Analysis was based on SAS.|||hypoglycaemic episodes|||Number
1315754|NCT02411578|Primary|Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment||30 minutes|Limited to events with starting BG of 50-69 mg/dL|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
1312673|NCT02500706|Secondary|Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation|A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.|Week 0 to week 26 (+7 days)|Analysis was based on SAS.|||Injection site reactions|||Number
1312674|NCT02500706|Secondary|Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation|A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.|Week 0 to week 26 (+7 days)|Analysis was based on SAS.|||events|||Number
1312675|NCT02500706|Secondary|Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)|The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for specified categories.|||Units||Standard Deviation|Mean
1312676|NCT02500706|Secondary|Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)|Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).|Week 0, week 26|Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1312677|NCT02500706|Secondary|Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia|The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
1312678|NCT02500706|Secondary|Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia|Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
1312679|NCT02500706|Secondary|Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L|Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
1312680|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements|The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).|Week 0, week 26|Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements.|||mmol/L||Standard Deviation|Mean
1312681|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1312714|NCT02500368|Secondary|Visual Quality|Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312682|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available data for PPG values and the PG value before the meal (breakfast, lunch, main evening meal).|||mmol/L||Standard Deviation|Mean
1312683|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal.|||mmol/L||Standard Deviation|Mean
1312684|NCT02500706|Secondary|Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile.|||mmol/L||Standard Deviation|Mean
1312685|NCT02500706|Secondary|Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation|Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints.|||mmol/L||Standard Deviation|Mean
1312686|NCT02500706|Secondary|Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation|Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints.|||mmol/L||Standard Deviation|Mean
1312687|NCT02500706|Secondary|Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation|The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
1312688|NCT02500706|Secondary|Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation|The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
1312689|NCT02500706|Secondary|Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation|The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
1312690|NCT02500706|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation|The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.|||mmol/L||Standard Deviation|Mean
1312691|NCT02500706|Secondary|Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation|The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol.|||ug/mL||Standard Deviation|Mean
1312692|NCT02500706|Secondary|Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)|The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG.|||mmol/L||Standard Deviation|Mean
1312693|NCT02500706|Primary|Change From Baseline in HbA1c 26 Weeks After Randomisation|Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.|||percentage of HbA1c||Standard Deviation|Mean
1312694|NCT02500628|Secondary|Number of Patients Reporting Side Effects From the Medication|Patient after testing generated an unprompted list of observed side effects from the medication. Many reported none. Results were scored as the binary presence or absence of side effect|2 hours after ingestion||||Participants|||Count of Participants
1312695|NCT02500628|Primary|Heart Rate Variability (Frequency Domain)|total power in the frequency domain is estimated for 10 minutes prior to metformin ingestion and then divided by the total power in the frequency domain estimated for 10 minutes 2 hours after metformin ingestion. Ratio is log-transformed.|difference pre/post metformin ingestion (2 hours)|patients with or without fibromyalgia. with or without antipsychotic use|||ratio||Standard Deviation|Mean
1312696|NCT02500628|Primary|Heart Rate Variability (Time Domain)|ratio of the standard deviation of sampled intervals between each heart beat for ten minutes at time 1 (prior to metformin ingestion) over standard deviation of the sampled intervals between each heart beat for ten minutes at time 2 (2 hours post metformin ingestion)|difference pre/post metformin ingestion (2 hours)|Patients with or without fibromyalgia, with or without antipsychotic use.|||msec/msec||Standard Deviation|Mean
1312697|NCT02500537|Secondary|Incidence of Repeat Hospital Admissions for Procedural-related Complications|Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure|30 Days following procedure||||participants|||Number
1312698|NCT02500537|Secondary|Staple Line Assessment:|Number of additional intervention(s) to treat staple-line failure|Participants will be followed for the duration of hospital stay, on average up to 5 days post-op||||participants|||Number
1312699|NCT02500537|Secondary|Staple Line Assessment: Incidence of Post-operative Infection|Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients|Participants will be followed for the duration of hospital stay, on average up to 5 days||||participants|||Number
1312700|NCT02500537|Secondary|Staple Line Assessment: Incidence of Leakage; Post-Op|The incidence of leakage for abdominal procedures; Post-up|Participants will be followed for the duration of hospital stay, on average up to 5 days|Abdominal patients only|||participants|||Number
1312701|NCT02500537|Secondary|Staple Line Assessment: Duration of Leakage, Post-Op|Duration of leakage based on chest tube drainage in days|Participants will be followed for the duration of hospital stay, on average up to 5 days|Thoracic patients only|||days||Standard Deviation|Mean
1312702|NCT02500537|Secondary|Staple Line Assessment: Incidence of Leakage|As measured by air leak test, or standard of care, as applicable|Day 0||||incidences of leakage|||Number
1312703|NCT02500537|Secondary|Staple Line Assessment: Incidence of Staple Line Bleeding|The incidence of staple line bleeding will be measured as ≥ 50 cc|Day 0||||incidences of staple line bleeding|||Number
1312704|NCT02500537|Primary|The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.||Through 30 Days||||Device related adverse events|||Number
1312705|NCT02500368|Secondary|Conjunctival Staining|Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312706|NCT02500368|Secondary|Conjunctival Indentation|Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|Baseline and 1 week.||||units on a scale||Standard Deviation|Mean
1312707|NCT02500368|Secondary|Corneal Staining (Extent)|"Corneal staining extent, grade as % of each zone:~C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior"|Baseline and 1 week||||percentage of cornea||Standard Deviation|Mean
1312708|NCT02500368|Secondary|Corneal Dehydration Staining|Corneal Staining: Dehydration Staining: Yes/No|1 week||||participants|||Number
1312709|NCT02500368|Secondary|Limbal Hyperemia|Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312710|NCT02500368|Secondary|Bulbar Hyperemia|Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312711|NCT02500368|Secondary|Overall Lens Fit|"Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);~Poor (lens could be worn with supervision only);~Fair (would prefer to refit, but clinically acceptable);~Good (fit could be slightly improved);~Very good (optimal)"|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312712|NCT02500368|Secondary|Ease of Lens Removal|Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.|1 week||||units on a scale||Standard Deviation|Mean
1312713|NCT02500368|Secondary|Ease of Lens Insertion|Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327532|NCT02140164|Secondary|Number of Non-ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.|||adverse events|||Number
1312717|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.~(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|1 week||||eyes|Eyes||Number
1312718|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.~(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline||||eyes|Eyes||Number
1312719|NCT02500368|Secondary|Lens Problems|Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.|Baseline and 1 week||||Lenses|Lenses||Number
1312720|NCT02500368|Secondary|Lens Deposition|Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312721|NCT02500368|Secondary|High Contrast Acuity at High Room Illumination|Logarithm of the Minimum Angle or Resolution (LogMAR) Chart|Baseline and 1 week||||LogMAR||Standard Deviation|Mean
1312722|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|1 week||||Eyes|Eyes||Number
1312723|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|Baseline||||Eyes|Eyes||Number
1312724|NCT02500368|Secondary|Lens Wettability|Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312725|NCT02500368|Primary|Dryness|Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312726|NCT02500368|Primary|Comfort|Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1312727|NCT02500056|Secondary|Foreign Body Feeling|The question about foreign body feeling was a yes-or-no question|6-month follow-up|Drop-outs at 6-month follow-up (3+6) not included|||percentage of patients with foreign body|||Number
1312728|NCT02500056|Secondary|Chronic Pain|On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise|3-year follow-up||||percentage of patients with pain|||Number
1312729|NCT02500056|Primary|Chronic Pain|On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise|6-month follow-up||||percentage of patients with pain|||Number
1312730|NCT02499952|Secondary|Disease Assessment for Duration of Disease Response|Duration of disease response|From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks|Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.||||||
1312731|NCT02499952|Secondary|Disease Assessment for Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Criteria|ORR of single agent pembrolizumab in subjects with refractory GCTs, determined by sum of complete responses and partial responses for at least 3 months using RECIST 1.1 criteria|From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks|Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.||||||
1312732|NCT02499952|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.|Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.|Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks||||Participants|||Count of Participants
1312733|NCT02499952|Primary|Clinical Benefit Rate (CBR)|"CBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC).~Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart.~Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation.~Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD."|up to 18 weeks||||percentage of participants w/ clinical b|||Number
1312734|NCT02499900|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods|An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. The investigator determined relation to study drug. A severe AE is defined as an inability to carry out usual activities. A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.|Core: Day 1 to Month 6 Extension: Month 7 to Month 12|Safety population|||Participants|||Count of Participants
1312749|NCT02499029|Secondary|PTSD Symptoms|PTSD Checklist - Military (PCL-M) The PCL-M is a seventeen question self-report, scored on a scale from 1 to 5, with possible scores ranging from 17 to 85. The scores from each question are summed to get a total score (17-85). A higher total indicates a higher severity of PTSD symptoms.|8 weeks||||units on a scale||Standard Deviation|Mean
1312750|NCT02499029|Secondary|Craving|Visual Analogue Scale (VAS) The VAS measures alcohol craving on a scale from 0 to 10. A higher score indicates a higher level of craving.|8 weeks||||units on a scale||Standard Deviation|Mean
1316321|NCT02395822|Secondary|Proportion of Patients Experiencing Grade, 3, 4, and 5 Toxicities (Assessed by CTCAE v. 4)||Days 1-5 and Days 8-12, 24 hours after the last IL-15 dose, Day +28, Day +42||||Participants|||Count of Participants
1312735|NCT02499900|Secondary|Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA|Depressive symptoms were measured by the BDI-II, a 21-item, self-reported rating inventory that measures characteristic attitudes and symptoms of depression. The BDI-II assesses mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, sadness, crying, irritability, social withdrawal, body image, work difficulties, insomnia, fatigue, appetite, weight loss, bodily preoccupation, and loss of libido. Each of the 21 items is rated on a 4-point scale ranging from 0 to 3. BDI-II Total Score indicates the severity of depression and has a total range of 0 to 63. For those clinically diagnosed, scores from 0-13 represent minimal depressive symptoms, scores of 14-19 indicate mild depression, scores of 20-28 indicate moderate depression, and scores of 30-63 indicate severe depression. Negative change from baseline scores indicate improvement.|Baseline (Month 0), Months 1, 3 and 6|Full analysis set.|||units on a scale||Standard Error|Least Squares Mean
1312736|NCT02499900|Secondary|Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA|The MHI consists of 18 items and provides an assessment of 4 subscales of mental health, including Anxiety (5 items), Depression (4 items), Behavioral control (4 items), and Positive Affect (4 items), and 1 Total Score. The subscales and Total Score for analyses range from 0 to 100, with 0 indicating not mentally healthy and 100 indicating superior mental health. Positive change from baseline scores indicate improved mental health. Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction. If a participant skipped x items of y items, the scale was not computed: - MHI Total Score - 9 of 19 - Anxiety subscale - 2 of 5 - Depression subscale - 2 of 4 - Behavioral Control subscale - 2 of 4 - MHI Positive Affect subscale - 2 of 4|Baseline (Month 0), Months 1, 3 and 6|Full analysis set.|||units on a scale||Standard Error|Least Squares Mean
1312737|NCT02499900|Secondary|Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA|MFIS is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. It is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on patient's activities. The Total MFIS score ranges from 0 to 84, the Physical Subscale from 0 to 36, the Cognitive Subscale from 0 to 40, and the Psychosocial Subscale from 0 to 8. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Negative change from baseline values indicate improvement in the effects of fatigue. Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from|Baseline (Month 0), Months 1, 3 and 6|Full analysis set (FAS). The participant was considered invalid if any of the items were missing.|||units on a scale||Standard Error|Least Squares Mean
1312738|NCT02499900|Secondary|Change From Baseline in the Treatment Satisfaction Questionnaire for Medication 9-item Version (TSQM-9) Convenience Score to Month 6 Using a Repeated Measures ANCOVA|Convenience perception was measured by the 3 convenience items (items 4 to 6) within the validated TSQM-9. The responses to each of the 3 convenience items are reported on a 1-to-7. The TSQM-9 convenience scale is computed, for each subject, by adding the 3 items loading on each response with the lowest possible total score (1*3 on the 3 items) subtracted from this composite score, and divided by the greatest possible score (3*7) minus the lowest possible score (3), i.e., 21-3=18. This provides a transformed score between 0 and 1 that was multiplied by 100. The final scale is 0 (Extremely Difficult/Inconvenient) to 100 (Extremely Easy/Convenient). If more than one item is missing, then the convenience scale was considered invalid for that patient. Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA with treatment, visit, and Country/Geographical Region as main factors, visit by treatment as the interaction term, and baseline score as the covariate.|Baseline (Month 0), Months 1, 3 and 6|Full analysis set (FAS) included those patients in the intent to treat (ITT) analysis set who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. Treatment naïve patients do not have TSQM-9 convenience scores at baseline and therefore are not included.|||units on a scale||Standard Error|Least Squares Mean
1312739|NCT02499900|Primary|Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA|Patient satisfaction with the study medication was assessed using the MSQ a 1-item global patient-rated scale. Patients were asked to respond on a 7-point scale, ranging from extremely dissatisfied (1) to extremely satisfied (7), to the following: “Overall, how satisfied are you with your current medication?”. Positive change from baseline score indicates greater satisfaction with the medication. Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction.|Baseline (Month 0), Months 1, 3 and 6|Full analysis set (FAS) included those patients in the intent to treat (ITT) analysis set who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. Treatment naïve patients do not have a MSQ score at baseline so are not included.|||units on a scale||Standard Error|Least Squares Mean
1312740|NCT02499692|Secondary|Myocardial Infarction (MI, Q-wave and Non–Q-wave) Rate||30 days||||percentage of participants|||Number
1312741|NCT02499692|Secondary|Target Vessel Failure (TVF) Rate||30 days||||percentage of participants|||Number
1312742|NCT02499692|Secondary|Target Vessel Revascularization (TVR) Rate||30 days||||percentage of participants|||Number
1312743|NCT02499692|Secondary|Target Lesion Failure (TLF) Rate||30 days||||percentage of participants|||Number
1312744|NCT02499692|Secondary|Target Lesion Revascularization (TLR) Rate||30 days||||percentage of participants|||Number
1312745|NCT02499692|Primary|Technical Success Rate|Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|1 day||||percentage of participants|||Number
1312746|NCT02499575|Secondary|Pain Relief Measured by Defense and Veterans Pain Scale|Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery|Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)||||units on scale of 0 -10|||Number
1312752|NCT02499029|Primary|PTSD Symptoms|Clinician Administered PTSD Scale IV (CAPS) The CAPS IV measures seventeen symptoms based on intensity and frequency. Intensity and frequency scores are summed to create a severity score for each question. Severity scores are summed to get a total score. A higher total score indicates a higher severity of PTSD symptoms.The full range for CAPS IV is 0-136.|8 weeks||||units on a scale||Standard Deviation|Mean
1312753|NCT02498821|Other Pre-specified|Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy)|Cost calculated as follows: mean (sum of material cost per PICC insertion, X-ray cost per PICC insertion, non-interventional radiology (IR) labor cost per PICC insertion, IR labor cost per PICC insertion).|Usually ranges from 0 to 300 minutes||||US dollars||Standard Deviation|Mean
1312754|NCT02498821|Other Pre-specified|Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event)|Nurse time associated with a malposition was defined as the time between when the nurse opened gathered materials for correcting the malposition (e.g., PICC kit, dressing change kit, saline, syringe) and when the subject was released for IV therapy.|Usually ranges from 0 to 30 minutes||||minutes|events|Standard Deviation|Mean
1312755|NCT02498821|Other Pre-specified|Nurse Time Associated With Initial PICC Placement (Per Patient)|Nurse time associated with initial PICC placement was defined as the time between when the nurse arrived at the subject and when the nurse left the room, minus the amount of time it took to conduct the research consent with the subject for the study; it includes time spent gathering supplies (before entering the subject’s room) and any consents obtained for the PICC procedure (not study-related consents).|Usually ranges from 0 to 150 minutes||||minutes||Standard Deviation|Mean
1312756|NCT02498821|Secondary|Number of Overtime Hours Worked Per PICC Placement Procedure||Measured from initiation to completion of procedure (usually from 0 to 5 hours)||||hours||Standard Deviation|Mean
1312757|NCT02498821|Secondary|Number of Lab Draws Missed Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Lab draws||Standard Deviation|Mean
1312758|NCT02498821|Secondary|Number of Medication Doses Missed Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Doses||Standard Deviation|Mean
1312759|NCT02498821|Secondary|Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Venous Access Devices (VADs)|||Number
1312760|NCT02498821|Secondary|Health Care Professional (HCP) Procedural Satisfaction (Overall)|HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning “not at all satisfied” and 10 meaning “extremely satisfied”.|Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).||||units on a scale||Standard Deviation|Mean
1312761|NCT02498821|Secondary|Number of Subsequent Malposition Attempts|This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt.|Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||malposition adjustment attempts|||Number
1312762|NCT02498821|Secondary|Number of Participants With Malpositions||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Participants|||Count of Participants
1312763|NCT02498821|Secondary|Total Number of Chest X-rays Performed Per Subject||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Chest X-rays||Full Range|Mean
1312764|NCT02498821|Primary|Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).||Usually ranges from 0 to 300 minutes from initiation of procedure||||minutes||Standard Deviation|Mean
1312765|NCT02498678|Secondary|Monitor Settings - Sensitivity|Sensitivity calculated by the monitor calibration, It is a numeric value that ranges from 1 to 512, but there is no measurement unit provided. Using the default CAL 2 function, the TOF-Watch® SX monitor automatically determines the sensitivity for a specific patient. The sensitivity can be adjusted between 1 and 512, where 512 represents the most sensitive setting. A sensitivity setting of 157 is the default value. This value represents how the monitor measures motor response of the patient to electrical stimulation of train of four (TOF). If the patient has intense motor response, the monitor reduces its sensitivity. If the patient has poor motor response, the monitor increase your sensitivity.|An expected average of 60 minutes||||units on a scale from 1 to 512||Standard Deviation|Mean
1312766|NCT02498678|Secondary|Monitor Settings - Electric Current|Electric current (milliampere) calculated by the monitor calibration|An expected average of 60 minutes||||milliampere||Standard Deviation|Mean
1312767|NCT02498678|Secondary|Time to Obtain T1 Height Stability|Time, in minutes, for the stabilization T1 height (maximum acceptable variation of up to 5%) before administration of neuromuscular blocking agent. According to the guidelines for good clinical research practice in pharmacodynamics studies of neuromuscular blocking agents, the monitor must present a stable response of T1 height (baseline) for a period of 2–5 min before administration of an neuromuscular blocking agents.|An expected average of 60 minutes||||seconds||Standard Deviation|Mean
1312768|NCT02498678|Primary|T1 Height|T1 height documentation when train of four reaches 0,9 (90%)|An expected average of 60 minutes||||percentage of T1 height||Standard Deviation|Mean
1312769|NCT02498678|Primary|Train of Four 0,9 (90%)|Time to recovery to train of four 0,9 (90%). When the fourth stimulus value (T4) divided by the first stimulus (T1) reaches the ratio of 0.9 (T4 / T1)|An expected average of 60 minutes||||minutes||Standard Deviation|Mean
1312770|NCT02498652|Primary|Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
1312771|NCT02498652|Primary|Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
1316322|NCT02395822|Secondary|In Vivo Expansion (>100) of NK Cells (Defined at CD56+/CD3- Lymphocytes)||Day 14 post NK cell infusion||||Participants|||Count of Participants
1312772|NCT02498652|Primary|Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||mg/dL||Standard Error|Mean
1312773|NCT02498652|Secondary|Number of Participants With Treatment-Emergent Adverse Events||11 weeks||||Number of participants|||Number
1312774|NCT02498652|Secondary|Apparent Terminal Half-life (t1/2)|t1/2 of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||hr||95% Confidence Interval|Geometric Mean
1312775|NCT02498652|Secondary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||µg·hr/mL||95% Confidence Interval|Geometric Mean
1312776|NCT02498652|Secondary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||µg·hr/mL||95% Confidence Interval|Geometric Mean
1312777|NCT02498652|Secondary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||hr||95% Confidence Interval|Geometric Mean
1312778|NCT02498652|Secondary|Maximum Observed Concentration (Cmax)|Cmax of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||µg/mL||95% Confidence Interval|Geometric Mean
1312779|NCT02498652|Primary|Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Maximum Percentage (%) Change||Standard Error|Mean
1312780|NCT02498652|Primary|Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
1312781|NCT02498652|Primary|Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
1312782|NCT02498652|Primary|Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||mg/dL||Standard Error|Mean
1312783|NCT02498652|Primary|Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Maximum Percentage (%) Change||Standard Error|Mean
1312784|NCT02498522|Primary|Miscarriage Rate||6 months||||participants||95% Confidence Interval|Number
1312785|NCT02497976|Secondary|Urgency Scale|Subjects rated their average urinary urgency or need to urinate using an 11-point numerical rating scale of 0-no urgency to 10-worse ever urgency|Value of Weeks 2, 4, 10, and 18 minus baseline||||units on a scale||Standard Deviation|Mean
1312786|NCT02497976|Secondary|Pain Scale|an 11-point pain intensity numerical rating scale. Subjects rated their average pain, pressure, or discomfort associated with their bladder using an 11-point pain intensity numerical rating scale of 0-no pain to 10-worse ever pain at baseline, and at weeks 2, 4, 10, and 18. Meaningful, clinically important pain relief is a reduction in pain of approximately 30% from baseline.|Value at Weeks 2, 4, 10, and 18 minus baseline||||units on a scale||Standard Deviation|Mean
1312787|NCT02497976|Secondary|IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI)|The Interstitial Cystitis Symptom Index (ICPI) is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 16 with severe symptoms.|Value of Weeks 2, 4, 10, and 18 minus baseline||||units on a scale||Standard Deviation|Mean
1312788|NCT02497976|Secondary|IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index|The Interstitial Cystitis Symptom Index is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 19 with severe symptoms. Lubeck et al. validated ICSI as a valid measure of change in treatment outcome studies. A change of -4.03 in the ICSI score was the same as a 2 point improvement in GRA. Propert et al. validated the ICSI as responsive to change in IC/BPS symptoms and was recommended as secondary endpoints in clinical trials. A change of -2.4 in the ICSI score was the same as a 2 point improvement in GRA.|Value at Weeks 2, 4, 10 and 18 minus Baseline||||units on a scale||Standard Deviation|Mean
1312789|NCT02497976|Secondary|IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)|Patient-reported global response assessment (GRA) such as “Compared to when you began this trial, how would you rate your IC symptoms now?” Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved.|Week 4, 10, 18||||Participants|||Count of Participants
1312809|NCT02497781|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Day 7|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2.|Day 7|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
1312790|NCT02497976|Primary|IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)|Patient-reported global response assessment (GRA) such as “Compared to when you began this trial, how would you rate your IC symptoms now?” Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved.|Week 2||||Participants|||Count of Participants
1312791|NCT02497781|Secondary|Percentage of Participants With Combined Response: Microbiologically Evaluable (ME) Analysis Population|Combined response was the combined assessment of clinical response and microbiological response. Favorable clinical response was defined as a clinical response of improvement and cure (at EOIV) and a clinical response of cure (at TOC). Cure defined as: resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required. Improvement defined as: participants who switched to oral therapy and had afebrile (temperature<=38.0°C) for >=24 hr; absence of new and improvement in at least 1 symptom or sign (ie, fever, pain, tenderness, elevated WBCs, elevated CRP) from Baseline and worsening of none. Favourable microbiological response was absence of the original baseline pathogen in source specimen. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|EOIV visit (Day 4 to 15), TOC visit (up to a maximum study duration of 50 days)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
1312792|NCT02497781|Secondary|Percentage of Participants With Favourable Combined Response: Microbiological Intent-to-treat (Micro-ITT) Population|Combined response was the combined assessment of clinical response and microbiological response. Favorable clinical response was defined as a clinical response of improvement and cure (at EOIV) and a clinical response of cure (at TOC). Cure defined as: resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required. Improvement defined as: participants who switched to oral therapy and had afebrile (temperature<=38.0°C) for >=24 hr; absence of new and improvement in at least 1 symptom or sign (ie, fever, pain, tenderness, elevated WBCs, elevated CRP) from Baseline and worsening of none. Favourable microbiological response was absence of the original baseline pathogen in source specimen. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|EOIV visit (Day 4 to 15), TOC visit (up to a maximum study duration of 50 days)|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants|||Number
1312793|NCT02497781|Secondary|Percentage of Participants With Emergent Infections: Microbiologically Evaluable (ME) Analysis Population|Emergent infections were categorized as super-infection and new infections. Superinfection: A urine culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: A urine culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Percentage of participants with any (super infections or new infections) of the infections were reported.|Baseline up to 50 days|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
1312794|NCT02497781|Secondary|Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population|Emergent infections were categorized as super-infection and new infections. Superinfection: A urine culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: A urine culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Percentage of participants with any (super infections or new infections) of the infections were reported.|Baseline up to 50 days|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants|||Number
1312795|NCT02497781|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Analysis Set at LFU|A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cUTI that required further antimicrobial therapy and/or surgery, or death after TOC in which cUTI was contributory. LFU visit occurred within 20 to 36 days after last dose of study treatment (IV or oral).|LFU visit (anytime up to a maximum study duration of 50 days)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
1312811|NCT02497781|Primary|Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters|Criteria for potentially clinically significant laboratory abnormalities: hematology (platelets: <0.4*lower limit of normal [LLN], >2*upper limit of normal [ULN], >40% decrease from baseline [DFB],>100% Increase from baseline [IFB]; Chemistry (Bicarbonate: <0.7*LLN, >1.3*ULN, >50% DFB, >30% IFB).|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime). Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1312796|NCT02497781|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Analysis Set at LFU|A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cUTI that required further antimicrobial therapy and/or surgery or death after TOC in which cUTI was contributory. LFU visit occurred within 20 to 36 days after last dose of study treatment (IV or oral).|LFU visit (anytime up to a maximum study duration of 50 days)|CE analysis set at LFU: participants >=1gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48hr of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic,were evaluated for clinical response of sustained cure or relapse.|||percentage of participants|||Number
1312797|NCT02497781|Secondary|Percentage of Participants With Favourable Microbiological Response: Microbiologically Evaluable (ME) Analysis Population|Favourable microbiological response was achieved when all baseline pathogens were eradicated. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 14 days).|EOIV visit (Day 4 to 15), EOT visit (up to Day 16)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
1312798|NCT02497781|Secondary|Percentage of Participants With Favourable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population|Favourable microbiological response was achieved when all baseline pathogens were eradicated. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 14 days).|EOIV visit (Day 4 to 15), EOT visit(up to Day 16)|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants|||Number
1312799|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR): Microbiologically Evaluable (ME) Analysis Population|Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants||95% Confidence Interval|Number
1312800|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at TOC: Clinically Evaluable (CE) Analysis Set at TOC|Favourable clinical response was defined as resolution of all acute signs/symptoms of cUTIs or improvement to such an extent that no further antimicrobial therapy was needed. Participants who met the following criterion: Incomplete resolution or worsening of cUTI signs or symptoms or development of new signs or symptoms requiring alternative non-study antimicrobial therapy or death in which cUTI was contributory. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|CE analysis set at TOC: participants >=1 gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48hr of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic, had clinical response of cure, improvement or failure at TOC.|||percentage of participants||95% Confidence Interval|Number
1312801|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at End of Treatment (EOT) Visit: Clinically Evaluable (CE) Analysis Set at EOT|Favourable clinical response was defined as a CR cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|EOT visit (up to Day 16)|CE analysis set at EOT: participants >=1 gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48hr of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic, had clinical response of cure, improvement or failure at EOT.|||percentage of participants||95% Confidence Interval|Number
1312810|NCT02497781|Primary|Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters|PCS criteria for abnormal value of ECG parameters: QT interval >=450 milliseconds (msec); 480 msec; >=500 msec; Increase from baseline (IFB) of >=30 msec; >=60 msec and >90 msec; Decrease from baseline (DFB) of >=30 msec; >=60 msec and >90 msec. QT interval using Bazett’s correction (QTcB): >=450 milliseconds (msec); 480 msec; >=500 msec; Increase from baseline (IFB) of >=30 msec; >=60 msec and >90 msec; DFB of >=30 msec; >=60 msec and >90 msec. QT interval using Fridericia’s correction (QTcF): >=450 msec; 480 msec; >=500 msec; IFB of >=30 msec; >=60 msec and >90 msec; DFB of >=30 msec; >=60 msec and >90 msec. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline until the EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
1312802|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at End of Intravenous Treatment (EOIV) Visit: Clinically Evaluable (CE) Analysis Set at EOIV|Favourable clinical response was defined as a CR of improvement and cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. Clinical Improvement included all the participants who had switched to oral therapy and had meet the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reactive-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 to 15)|CE analysis set at EOIV: participants >=1 gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48 h of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic, had clinical response of cure, improvement or failure at EOIV.|||percentage of participants||95% Confidence Interval|Number
1312803|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at End of 72 Hours Treatment: Clinically Evaluable (CE) Analysis Set at 72 Hours|Favourable clinical response was defined as a CR of improvement and cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. Clinical Improvement included all the participants who had improvement but not enough to switch to oral therapy and were still on IV study drug at End of 72 hours and had meet the following criterion: absence of new signs and symptoms, and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated CRP) from baseline, and with no worsening of any symptom or sign.|End of 72 hours study drug treatment on Day 1|CE analysis set at 72hr: participants who had at least 1 gram negative typical pathogen (in urine) at baseline known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed diagnosis of cUTI, >=48hr of IV study drug, unless discontinued due to treatment-limiting AE, no important protocol deviations and no concomitant antibiotics.|||percentage of participants||95% Confidence Interval|Number
1312804|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR): Microbiological ITT (Micro-ITT) Analysis Population|Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|End of 72 hours study drug treatment, EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants||95% Confidence Interval|Number
1312805|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR): Intent-to-treat (ITT) Analysis Population|Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|End of 72 hours study drug treatment, EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1312806|NCT02497781|Secondary|Plasma Concentrations of Ceftazidime and Avibactam||15, 30-90, 300-360 minutes post-dose on Day 3|PK analysis set included all randomized participants who received any amount of CAZ-AVI and had at least 1 CAZ and/ or AVI plasma measurement available. This outcome measure was not planned to be analyzed for Cefepime receiving cohort, as pre-specified in protocol.|||nanogram per milliliter||Standard Deviation|Geometric Mean
1312807|NCT02497781|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
1312808|NCT02497781|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Treatment (EOIV) Visit|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
1312812|NCT02497781|Primary|Change From Baseline in Body Weight at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||kilogram||Standard Deviation|Mean
1312813|NCT02497781|Primary|Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Treatment (EOIV) Visit|Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer’s discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
1312814|NCT02497781|Primary|Change From Baseline in Body Temperature at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime). Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||degree Celsius||Standard Deviation|Mean
1312815|NCT02497781|Primary|Change From Baseline in Respiratory Rate at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||breaths per minute||Standard Deviation|Mean
1312816|NCT02497781|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1312817|NCT02497781|Primary|Change From Baseline in Pulse Rate at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||beats per minute||Standard Deviation|Mean
1312818|NCT02497781|Primary|Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)|Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of diarrhea, renal disorder, hematological disorder and liver disorder relevant to the cephalosporin class within the safety topics (ST) based on MedDRA 20.0) were reported in this outcome measure.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
1312819|NCT02497781|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 36 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
1312820|NCT02497755|Secondary|Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.|The mean number of Follow-Up contacts between patient and care manager during the 8 weeks following the patient's activation of the app. (Other types of contacts with the care manager include Initial Assessment and Contact Attempt, but neither of these occurred during the time frame of app use.)|Eight weeks after intervention started||||number of contacts||Full Range|Mean
1312821|NCT02497755|Secondary|Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) – Communication Scale|The mean total of patient app users' responses to the 6 items in the Consumer Assessment of Healthcare Providers and Systems (CAHPS) – Communication scale, with a mean score of 0-5 indicating that participants never or almost never experienced good communication with their care team, 6-11 indicating that participants sometimes experienced good communication with their care team, 12-17 indicating that patients usually experienced good communication with their care teams, and a score of 24 indicating that patients always experienced good communication with their care team.|Weeks 4 and 8|Only 13 participants were analyzed at the 8 week point because only 13 participants of the 17 completed the Week 8 survey.|||units on a scale||Full Range|Mean
1312822|NCT02497755|Secondary|Patient Use of the App as Measured by Percentage of App Surveys Completed.|The mean percentage of surveys presented to users through the app that were completed by patient app users in their first 8 weeks of using the app. App survey questions included weekly PHQ-9 and GAD-7 scales and daily measures of mood and medication use as well as satisfaction surveys.|Eight weeks after intervention started||||Percentage of surveys completed||Full Range|Mean
1312823|NCT02497755|Secondary|Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey.|The mean total of patient app users' responses to the Ginger.io product feedback survey, with a mean score of 7-21 indicating satisfaction with the app, 22-34 neutrality, and 35-49 expressing dissatisfaction.|Days 30, 56|Overall Number of Participants Analyzed (13) is not consistent with numbers provided in the Participant Flow model (17) because 4 of the participants did not complete the Day 30 or the Day 56 survey. Only 2 participants were analyzed at the 56 day point because only 2 participants completed the Day 56 survey.|||units on a scale||Full Range|Mean
1312824|NCT02497755|Secondary|Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)|The mean total of patient app users' responses to the modified version of the Obtrusiveness Scale for Pervasive Technology, with a mean score of 13-39 indicating that the app is generally perceived as unacceptable/obtrusive, 40-64 indicating neutrality, and 65-91 indicating that the app is generally perceived as acceptable/unobtrusive.|During weeks 3 and 8|Only 3 participants were analyzed at the 8 week point because only 3 participants of the 17 completed the Week 8 survey.|||units on a scale||Full Range|Mean
1312825|NCT02497755|Primary|App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful|The number of care managers who expressed that the app was useful to them with regard to clinical workflow in a qualitative interview.|8-16 weeks after final patient participant is enrolled||||Participants|||Count of Participants
1312826|NCT02497755|Primary|App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful|"The number of patients who rated the app as useful to them when asked about app usefulness in a qualitative interview and via a quantitative survey. Specific survey items included This technology is useful. All patients who expressed agreement (Somewhat Agree, Agree, or Strongly Agree) to this items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable."|Four weeks after intervention started|Overall Number of Participants Analyzed (16) is not consistent with numbers provided in the Participant Flow model (17) because one participant did not complete the quantitative survey used in this analysis.|||Participants|||Count of Participants
1312827|NCT02497755|Primary|App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable|The number of care managers who agreed that the app dashboard was easy to use and that the amount of time spent using the app dashboard was reasonable when asked about app acceptability and benefit vs. burden of use with regard to clinical workflow in a qualitative interview.|8-16 weeks after final patient participant is enrolled||||Participants|||Count of Participants
1312828|NCT02497755|Primary|App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable|"The number of patients who rated the app was easy to use and the amount of time spent using the app as reasonable when asked about app acceptability in a qualitative interview and via a quantitative survey. Specific survey items included The technology requires little effort to use, The technology was easy to learn how to use, The Ginger.io app is easy to use, and The time required to answer questions in the Ginger.io app is reasonable. All patients who expressed agreement (Somewhat Agree, Agree, or Strongly Agree) to these items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable."|Four weeks after intervention started|Overall Number of Participants Analyzed (16) is not consistent with numbers provided in the Participant Flow model (17) because one participant did not complete the quantitative survey used in this analysis.|||Participants|||Count of Participants
1312829|NCT02497235|Secondary|Percent Change From Baseline in the AUEC24 for Plasma 24S Hydroxycholesterol (24HC)|Percent change was calculated as = [(Postdose AUEC24(2) – Baseline AUEC24(2))/Baseline AUEC24(2)]*100 percent.|Baseline (Day -1): 1 hour and at multiple timepoints (up to 12 hours) post check in and Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-TAK-935 dose|PK set included all participants who received TAK-935 and had at least 1 measurable plasma concentration for either TAK-935 or its M-1 metabolite. Data was reported for Participant 1 and 2 of each of TAK-935 50, 100, 200, and 300 mg arms and Participant 1, 2, and 3 of TAK-935 600 mg arm.|||percent change|||Number
1312830|NCT02497235|Secondary|Plasma Concentration of TAK-935 During Post-TAK-935 Dosing PET Scan Periods||At time 0 (just after tracer injection), 1 hour after tracer injection and 2 hours after tracer injection for each post-TAK-935 dosing PET scan period|Pharmacokinetic (PK) set included all participants who received TAK-935 and had at least 1 measurable plasma concentration for either TAK-935 or its M-1 metabolite. Data was reported for Participant 1 and 2 of each of TAK-935 50, 100, 200, and 300 mg arms and Participant 1, 2, and 3 of TAK-935 600 mg arm.|||nanogram per milliliter (ng/mL)|||Number
1312831|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 24 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.|24 hours post-TAK-935 dose|PET target occupancy set where 24 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
1312832|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 10 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 10 hour post-TAK-935 dose.|10 hours post-TAK-935 dose|PET target occupancy set where 10 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
1312857|NCT02496221|Primary|Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.|Day 4 in each treatment period|Evaluable Subjects|||Millilitre (mL)||Standard Error|Mean
1312833|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 2 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.|2 hours post-TAK-935 dose|PET target occupancy set where 2 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
1312834|NCT02497235|Primary|Cholesterol 24S-Hydroxylase (CH24H) Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 45 Minutes Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: total volume of distribution [VT] (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - non-displaceable volume of distribution [VND]), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 45 minutes post-TAK-935 dose.|45 minutes post-TAK-935 dose|PET target occupancy set where 45 minutes post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
1312835|NCT02497040|Primary|Change in Mean Arterial Pressure||220+-70 minutes||||mmHg||Standard Deviation|Mean
1312836|NCT02496702|Secondary|Acceptability of IMT|Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT|At week 14.||||percentage of happy to train on IMT|||Number
1312837|NCT02496702|Secondary|Motivation for Training|Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.|At week 14.||||percentage of wanting to continue|||Number
1312838|NCT02496702|Secondary|Adherence to Training, Composite Outcome Measure.|Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.|At week 14||||percentage of sessions||95% Confidence Interval|Mean
1312839|NCT02496702|Secondary|Change From Baseline in Test Score of Static Balance at Week 14.|Static Balance will be measured using Wii Balance Board, which have proven to be a valid measure of balance (Sgró 2014). This measure will be done using an application developed by Francesco Sgró and colleagues (Sgró 2014). Baseline score compared to score at week 14.|Baseline and at week 14|Data were not collected.||||||
1312840|NCT02496702|Secondary|Change From Baseline in Test Score of Line Walk at Week 14.|Number of steps a person can do on a line directly after the foot without touching outside the line. Baseline score compared to score at week 14.|Baseline and at week 14||||Steps||95% Confidence Interval|Mean
1312841|NCT02496702|Primary|Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.|Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14.|Baseline and at week 14||||seconds||95% Confidence Interval|Mean
1312842|NCT02496702|Primary|Change From Baseline in Test Score of 30-second Chair Stand at Week 14.|Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.|Baseline and at week 14||||Full chair stands per 30 seconds||95% Confidence Interval|Mean
1312843|NCT02496702|Primary|Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.|Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14.|Baseline and at week 14||||m||95% Confidence Interval|Mean
1312844|NCT02496533|Secondary|Change in Pulse Rate|A trained clinician will measure and record the subject's radial pulse rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||beats per minute||Standard Deviation|Mean
1312845|NCT02496533|Secondary|Change in Respiration Rate in Breaths Per Minute|A trained clinician will measure and record the subject's respiration rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||breaths per minute||Standard Deviation|Mean
1312846|NCT02496533|Secondary|Change in Blood Pressure in mmHg|A trained clinician will measure and record the subject's blood pressure using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||mmHg||Standard Deviation|Mean
1312847|NCT02496533|Primary|Change in Anxiety as Measured by Visual Analog Scale|Subjects self-reported their perceived anxiety by marking a visual analog scale (VAS). The VAS covers the range 0 to 10. Higher values indicate greater anxiety (worse outcome). Analysis based on difference reported anxiety score between Baseline and after imaging.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
1312848|NCT02496221|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|Urine dipstick test was carried out on Day -1 and at Follow-up. Urinalysis parameters assessed were glucose, ketones, nitrite and protein. Dipstick results were categorized as Normal (glucose), Negative or Trace (ketones), and Negative (nitrite and protein). Only participants available at the indicated time points (as represented by n=X, X, X in the category titles) were analyzed. The resultant fields with no available data have been represented by 'NA'.|Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects|||Participants|||Number
1312858|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Volume (AUEC VL)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error is presented.|Day 4 in each treatment period|Evaluable Subjects|||mL*min||Standard Error|Mean
1312849|NCT02496221|Secondary|Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgement. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)|All Subjects|||Participants|||Number
1312850|NCT02496221|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters|Single 12-lead ECG was obtained in a semi-supine position after 5 minutes of rest at each indicated time point using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT, and QT corrected by Fridericia's formula (QTcF) intervals. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)|All Subjects|||Milliseconds (msec)||Standard Deviation|Mean
1312851|NCT02496221|Secondary|Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance|The following parameters were measured through blood sampling. Hematology: Hematocrit, Hemoglobin, Lymphocytes, Neutrophil Count, Platelet Count, While Blood Cell Count (WBC); Clinical Chemistry: Albumin, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Potassium, Sodium, Total carbon dioxide; Liver Function Tests: Alanine transaminase (ALT), Aspartate transaminase, Alkaline Phosphatase, Total Bilirubin, Total Bilirubin + ALT. Values were considered to be of potential clinical importance if they had a 'low' or 'high' flag with respect to a pre-defined clinical concern range. Only participants starting each period (represented by n=X) with a particular treatment were analyzed. The follow-up time point is not restricted to a treatment or treatment period.|Day -1 in each treatment period and Follow-up (at approximately Week 12)|All Subjects|||Participants|||Number
1312852|NCT02496221|Secondary|Change From Baseline in Heart Rate|Baseline is defined as Day 1 (pre-dose) visit. Heart rate was measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)|All Subjects|||Beats per minute (bpm)||Standard Deviation|Mean
1312853|NCT02496221|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline is defined as Day 1 (pre-dose) visit. SBP and DBP were measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 1 (pre-dose), Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1312854|NCT02496221|Primary|Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion|Common bile duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable for Bile: Participants with Baseline and post-Baseline common bile duct diameter values for both periods|||Centimetre (cm)||Standard Error|Mean
1312855|NCT02496221|Primary|Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion|Pancreatic duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error are presented. Baseline was calculated as the value at the indicated time point minus the Baseline value. Only those participants available at the indicated time points were analyzed.|Day 4 in each treatment period|Evaluable for Pancreatic: Participants with Baseline and post-Baseline pancreatic duct diameter values for both periods|||Centimetre (CM)||Standard Error|Mean
1312856|NCT02496221|Primary|Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects|||Minutes||Standard Deviation|Mean
1312859|NCT02496221|Primary|Maximum Gallbladder Ejection Fraction Value During CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 1 and Day 4 in each treatment period|Evaluable Subjects|||Percentage||Standard Error|Mean
1312860|NCT02496221|Primary|Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects|||Minutes||Standard Deviation|Mean
1312861|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects|||%*min||Standard Error|Mean
1312862|NCT02496221|Primary|Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect|Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects: Participants in the ‘All Subjects’ population who had gallbladder ultrasonography assessment pre-treatment and post-Baseline (during CCK infusion) for both periods. 'All Subjects' population comprised participants who received at least one dose of Investigational product.|||Percent of gallbladder EF||Standard Error|Least Squares Mean
1312863|NCT02496039|Primary|Scores on the Impact of PBA on Informant Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312864|NCT02496039|Primary|Number of Participants Using Concomitant Psychotropic Medication|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312865|NCT02496039|Primary|Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312866|NCT02496039|Primary|Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312867|NCT02496039|Primary|Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312868|NCT02496039|Primary|Scores on the Patient Global Impression of Change (PGIC) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312869|NCT02496039|Primary|Scores on the Clinical Global Impression of Change (CGIC) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312870|NCT02496039|Primary|Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312871|NCT02496039|Primary|Scores on the Center for Neurologic Study-Lability Scale (CNS-LS)|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
1312872|NCT02496000|Secondary|The Effect of ORMD-0801 on Changes in HbA1c|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on percent changes from baseline to Wk 4 in HbA1c|Study day 1 (± 1 day) through Study day 29 (± 1 day)||2018-03-31|03/2018||||
1312873|NCT02496000|Secondary|Effect of ORMD-0801 on Mean Daytime Glucose|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on changes from baseline to Wk 4 of Continuous Glucose Monitoring (CGM) of mean daytime glucose, measured in mg/dL|Study day 1 (±1 day) through Study day 29 (± 1 day)||2018-03-31|03/2018||||
1312874|NCT02496000|Secondary|The Difference of Mean (mg/dL) Fasting Glucose From Baseline to Week 4|The effect of ORMD-0801 (Dose 1 and Dose 2 pooled and individually) on absolute changes from baseline to Wk 4 in fasting morning blood glucose.|Study day 1 (± 1 day) through Study day 29 (± 1 day)||2018-03-31|03/2018||||
1312875|NCT02496000|Secondary|The Effect of ORMD-0801 on Mean 24-hour Glucose|The effect of ORMD-0801 (Dose 1 and Dose 2 individually and pooled) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups measured in mg/dL|Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)||2018-03-31|03/2018||||
1312888|NCT02495259|Secondary|Success Rate of First Endobronchial Intubation Attempt|The rate of first intubation attempt success will be recorded by the anesthetist. A successful first attempt intubation is when the double-lumen endobronchial tube is placed during the initial laryngoscopy within 120 seconds. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2). Higher numbers of successful first attempt intubations indicate better rates of success of first endobronchial intubation attempts .|during laryngoscope placement, up to 120 seconds||||Participants|||Count of Participants
1316323|NCT02395822|Primary|< 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L|Without platelet recovery|Day 42 post NK cell infusion||||Participants|||Count of Participants
1312876|NCT02496000|Primary|Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.|The Effect of ORMD-0801 (Doses 1 & 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.|Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)|Intend-to-Treat Population, 80% trimming. The mean values will be analyzed using a one-way analysis of variance (ANOVA) model. The residuals from the ANOVA will be analyzed to verify that they are normally distributed. If not normally distributed, then a Kruskal-Wallis test (one-way analysis of variance on the ranks) will be performed.|||mg/dL||Standard Deviation|Mean
1312877|NCT02495948|Primary|Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear|The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.|Day 30, each product|Intent-to-Treat analysis set|||micrograms|Lenses|Standard Deviation|Mean
1312878|NCT02495831|Secondary|Relative Bioavailability (Frel)|calculated as ratio between AUC0-t (test) / AUC0-t (reference)|24 hours||||ratio||Standard Deviation|Mean
1312879|NCT02495831|Secondary|Lamda z||24 hours||||1/hours||Standard Deviation|Mean
1312880|NCT02495831|Secondary|Tmax and T1/2||24 hours||||hours||Standard Deviation|Least Squares Mean
1312881|NCT02495831|Secondary|Evaluate Diclofenac Rate of Absorption Reported as Plasma Cmax After Single Administration of 50 mg Diclofenac With and Without 200 mg of Safinamide.|Cmax, of plasma diclofenamic acid after T2 single dose, with and without T1 co-administration. The parametric point estimators (PE) for the ratios of T2 treatment with T1 co-administration / T2 treatment without T1 co-administration for the PK parameters under consideration, and the two-sided 90% confidence interval (CI), were calculated using the adjusted least squares means (LSMEANS) from the ANOVA. LSmeans differences obtained in the log scale for Cmax were back-transformed to obtain the PE (i.e. geometric mean ratio) and the two-sided 90% CI as percentages.|24 hours||||ng/mL||Standard Deviation|Least Squares Mean
1312882|NCT02495831|Primary|To Evaluate Plasma Diclofenamic Acid Extent of Exposure Reported as Plasma AUC After Single Administration of 50 mg Diclofenac Sodium, With and Without Co-administration of a Single 200 mg Dose of Safinamide.|Plasma diclofenamic acid AUC0-t after T2 single dose, with and without T1 co-administration. To measure AUC plasma samples were taken by the participants at different time points, and the concentrations of diclofenac and safinamide were measured. AUC0-t is the area under the concentration-time curve from administration to the last observed concentration time t; PK parameters AUC0-t were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.|24 hours|healthy volunteers|||h X ng per mL||Standard Deviation|Mean
1312883|NCT02495623|Primary|Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7||7 days|79 subjects consented/randomized to treatment. 63 dosed subjects. 59 subjects (21, 20 & 18 for the placebo, 21mg and 42mg, respectively) were included for the analysis of AUC on Day 7, and the subjects with missing CH4 values at either baseline or Day 7 were excluded from the analysis since the area under the curve could not be calculated.|||hours*ppm||Standard Deviation|Mean
1312884|NCT02495259|Secondary|Throat Pain|Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by recording the patient's response to the degree of pain experienced. An analog pain scale will be used for scoring where: 0= no pain and 10= severe pain. The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.|Up to 60 minutes after extubation||||units on a scale||Standard Deviation|Mean
1312885|NCT02495259|Secondary|Number of Cases of Voice Change|Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by asking the patient if any change in voice is experienced (Yes/No). The subjective answer given by the patient will be recorded. The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.|Up to 60 minutes after extubation||||cases of voice change|||Number
1312886|NCT02495259|Secondary|Number of Cases With Complications|Number of cases with complications during intubation will be will be assessed by the anesthetist's responses to a multi-question form which includes the following items; blood on device, SpO2 (peripheral capillary oxygen saturation) <96%, lip and dental trauma and double-lumen endobronchial tube (DLT) cuff rupture. The responses are recorded as Yes or No for each item. A 'yes' response indicates a complication. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).|during laryngoscope placement, up to 120 seconds||||cases of complications|||Number
1312887|NCT02495259|Secondary|Assessment of Difficulty of Intubation|The ease of successful placement of the double-lumen endobronchial tube (DLT) will be assessed by the anesthetist's responses to a multi-question form which includes the following items that are scored; overall ease of intubation, laryngoscope insertion, glottic view, double-lumen endobronchial tube (DLT) delivery and placement. The subjective scores range from 0-10; where 0=worst, 10=best. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).|during laryngoscope placement, up to 120 seconds||||units on a scale||Standard Deviation|Mean
1312962|NCT02492841|Secondary|Adverse Effects|Name any adverse effects.|1 week, 3 and 6 months|There were no adverse effects in the population studied.|||Participants|||Count of Participants
1312963|NCT02492841|Primary|Treatment Outcome|vitality test with electric device cold and hot test radiographic evaluation|3 months, 6 moths and 12 months|Intent a preventive treatment against cavities to avoid endodoncies with different treatments and see which one is more effective after 12 months follow up.|||Participants|||Count of Participants
1312889|NCT02495259|Primary|Mean Time to Place the Double-lumen Endobronchial Tube|The time taken for successful intubation will be recorded by the anesthetist. The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds. A higher duration noted is indicative of a longer time taken for successful intubation. 0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)|during laryngoscope placement, up to 120 seconds||||sec||Standard Deviation|Mean
1312890|NCT02495038|Other Pre-specified|Bispectral Index|"The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer.~Before induction of anesthesia, bispectral index was measured for baseline. And after injection of NMBAs, bispectral index was measured at 10 min."|Before and after induction of anesthesia, an average 10 min.||||BIS score||Standard Deviation|Mean
1312891|NCT02495038|Other Pre-specified|Body Temperature|"Before induction of anesthesia, body temperature was measured for baseline by oral temperature probe.~And after injection of NMBAs, non invasive blood pressure was measured at 10 min by esophageal temperature probe."|Before and after induction of anesthesia, an average 10 min.||||Celcius degree||Standard Deviation|Mean
1312892|NCT02495038|Other Pre-specified|Peripheral Oxygen Saturation|"Before induction of anesthesia, peripheral oxygen saturation was measured for baseline.~And after injection of NMBAs, peripheral oxygen saturation was measured at 10 min."|Before and after induction of anesthesia, an average 10 min.||||Percentage||Standard Deviation|Mean
1312893|NCT02495038|Other Pre-specified|Non Invasive Blood Pressure,|"Before induction of anesthesia, non invasive blood pressure was measured for baseline.~And after injection of NMBAs, non invasive blood pressure was measured at 10 min."|Before and after induction of anesthesia, an average 10 min.||||mmHg||Standard Deviation|Mean
1312894|NCT02495038|Secondary|Additional Rescue Doses Per Hour Ratio.|Additional Rescue Doses Per Hour Ratio is the number per hour of addition of rescue dose administrated with 10% of initial NMBAs dose. The formula is {(Addition number + 1 / Anesthetic time) x 60}.|Intraoperative, an average of 3 hours.||||ratio||Standard Deviation|Mean
1312895|NCT02495038|Secondary|Anesthetic Time|Time from induction to recovery of anesthesia, asessed up to 3 hours.|Intraoperative, an average 4 hours.||||Minute||Standard Deviation|Mean
1312896|NCT02495038|Secondary|Operation Time|Time from skin incision to wound dressing assessed up to 8 hours.|Intraoperative, an average of 3 hours.||||Minute||Standard Deviation|Mean
1312897|NCT02495038|Primary|Recovery Index of Neuromuscular Blocking Agents(NMBAs)|Time from TOF ratio 25% to 75%, assessed up to 1 hour during general anesthesia.|Intraoperative, an average of 20 minutes||||Minute||Standard Deviation|Mean
1312898|NCT02495038|Primary|Duration 25% of Neuromuscular Blocking Agents(NMBAs)|Time from administration of initial NMBAs to Train-of-four (TOF) ratio >25%, assessed up to 2 hours during general anesthesia.|Intraoperative, an average of 1 hours||||Minute||Standard Deviation|Mean
1312899|NCT02495038|Primary|Onset of Neuromuscular Blocking Agents(NMBAs)|Time from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia.|Intraoperative, an average of 5 minutes||||Second||Standard Deviation|Mean
1312900|NCT02494596|Secondary|Time to Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population|||hours||Standard Deviation|Mean
1312901|NCT02494596|Secondary|Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is an oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety 5-FU in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5'-DFCR, 5'-DFUR, and FBAL. Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL).|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population|||ng/mL||Standard Deviation|Mean
1312902|NCT02494596|Secondary|Plasma Half-Life of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5’-deoxy-5-fluorocytidine (5'-DFCR), 5’-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). The biological half-life or terminal half-life is the time in days it takes for it to lose half of its pharmacologic activity.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population|||hours||Standard Deviation|Mean
1312903|NCT02494596|Secondary|Apparent Total Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||mL/day||Standard Deviation|Mean
1312904|NCT02494596|Secondary|Apparent Volume of Distribution of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Vss was measured in mL|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||mL||Standard Deviation|Mean
1327533|NCT02140164|Secondary|Number of Ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.|||adverse events|||Number
1312905|NCT02494596|Secondary|AUC From Time Zero to Infinity (AUC 0-infinity) of Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as nanograms times days per milliliter (ng*day/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||ng*day/mL||Standard Deviation|Mean
1312906|NCT02494596|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC was measured as ng*day/mL.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||ng*day/mL||Standard Deviation|Mean
1312907|NCT02494596|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. Tmax was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||days||Standard Deviation|Mean
1312908|NCT02494596|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and was measured as nanograms per milliliter (ng/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||ng/mL||Standard Deviation|Mean
1312909|NCT02494596|Secondary|Plasma Half-Life (t1/2) of Pertuzumab|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity. t1/2 was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and Predose on Days 8, 15 and 22|ITT population|||days||Standard Deviation|Mean
1312910|NCT02494596|Secondary|Percentage of Participants With DLTs|DLTs were defined as follows: 1)Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT.|Cycle 1 (3 Weeks)|Safety population|||percentage of participants|||Number
1312911|NCT02494596|Primary|Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine|MTD was defined as the highest tolerated dose combination of capecitabine (825 mg, 1000 mg or 1250 mg) and pertuzumab, without causing Dose Limiting Toxicities (DLTs). DLTs were defined as follows: 1) Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT. MTD was measured in mg/m^2.|Cycle 1 (3 Weeks)|The Safety Population included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.|||mg/m^2|||Number
1312912|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound|"The femur length at Five-Dimensional Ultrasound: To obtain 3D volume data, the entire bone length of the femur was identified on the screen, as in the 2D-ultrasound measurement, and the long axis of the femur was placed in the direction of the x axis in the image in which the ultrasound beam was perpendicular to the bone. The 5D LB set key was pressed on the system, wherein the system automatically analyzed the 3D volume data, reconstructed the 3D image of the long bones, and displayed the measured length of the femur length on the screen was measured by pressing 5D LB Button to extract Fetal Long Bones automatically.~then, gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria|||weeks||Standard Deviation|Mean
1312913|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound|"The femur length at Two-Dimensional Ultrasound (Gold standard) was made from the center of the 'U' shape at each end of the bone. After the long axis of the fetus was identified, the transducer was turned 90 degrees to produce a cross sectional image of fetal trunk, maintaining the 90 degrees angle until the lower spine and iliac crest were identified, then the transducer was rotated until a full femur was imaged. The femur length was measured from the center of the U shape at each end of the bone; this represented the length of the metaphysis).~then , Gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria|||weeks||Standard Deviation|Mean
1312914|NCT02494440|Primary|Gestational Age Calculated by Accurate Dates of the Last Menstrual Period|"The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy.~Gestational age calculated by the last menstrual period"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria|||weeks||Standard Deviation|Mean
1312915|NCT02494323|Secondary|Benefit Satisfaction Willingness to Continue (BSW) Questionnaire|Number of subjects who benefited or not benefited from the dual channel electrode was counted, number of patients who were satisfied or not satisfied with the dual channel electrode was counted, number of subjects who were willing to continue or who were unwilling to continue with the dual channel electrode was counted|7 months|Five subjects were excluded from filling up the BSW questionnaire, since the Segmented Electrode (SE) did not produce motor reaction in the ankle|||participants|||Number
1312916|NCT02494323|Primary|Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE|Subjects were fitted with the L300 Cuff that houses the single channel QFE and then the modified cuff that houses the dual channel segmented electrode. Subjects were stimulated first sitting and then after optimal ankle elevation was achieved, they walked with the stimulation. The clinician documented ankle movement on a 5 point scale: 1-inverted dorsiflexion, 2-slightly inverted dorsiflexion, 3-neutral dorsiflexion,4- slightly everted dorsiflexion, 5- everted dorsiflexion. The clinician documented the number of subjects who achieved each movement with each electrode according to the 5 point scale.|7 months|All subjects suffer from foot drop due to upper motor neuron lesion|||units on a scale||Standard Deviation|Mean
1312917|NCT02494076|Secondary|Rate of Inpatient Hospitalization|Number of patients in each group requiring hospital admission|After intervention or control and until follow-up phone call 72 hours after disposition|2 patients excluded due to missing data and protocol error|||Participants|||Count of Participants
1312918|NCT02494076|Secondary|Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control|Second line therapies include: continuous albuterol, intravenous magnesium sulfate, subcutaneous or intravenous terbutaline, non-invasive ventilation (BiPAP or CPAP), and supplemental oxygen. The need for these second line therapies will be assessed by the child's treating team in the Emergency Department.|participants will be followed for the duration of ED stay, an expected average of 6-8 hours|2 subjects excluded from analysis due to missing data|||Participants|||Count of Participants
1312919|NCT02494076|Primary|Change in Pulmonary Asthma Score (PAS)|The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores < 7 correspond with mild asthma exacerbations, while scores ≥ 7 and < 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma. The primary outcome was determined by subtracting the post-intervention score from the pre-intervention score.|0-30 minutes|2 patients in EzPAP group were excluded from analysis due to protocol error and missing data.|||mean PAS score||Standard Deviation|Mean
1312920|NCT02493855|Primary|Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment|HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.|From Week 0 to Week 2|Participants with evaluable HCV RNA to calculate the slope of the second phase. Three participants were excluded due to algorithm non-convergence in the non-linear modeling process.|||1/day||Full Range|Median
1312921|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of both hands after completing intervention. Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1||||pounds||Standard Deviation|Mean
1312922|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of the injured hand after completing intervention. Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1||||pounds||Standard Deviation|Mean
1312923|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of the non-affected hand after completing intervention. Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1||||pounds||Standard Deviation|Mean
1312924|NCT02493127|Primary|Positive Pain Catastrophizing Scale (PCS)|The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.|enrollment||||units on a scale||Standard Deviation|Mean
1312925|NCT02493127|Primary|Pain Catastrophizing Scale (PCS)|The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.|enrollment||||units on a scale||Standard Deviation|Mean
1312926|NCT02493088|Secondary|Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression)|"Auto-aggressive: attempted suicide, any gesture of mutilation (scarification, punching in a wall, etc.) Aggressive: rixes with fellow inmates or prison staff, attempted homicides, sexual assaults, etc.~Other hetero transgression: Failure to comply with the rules of the institution, illegal entry of illicit objects into the establishment, consumption of toxic materials, destruction of property, etc."|6 months||||number of observed situations|||Number
1312927|NCT02493088|Secondary|Percentage of Aberrant Driving Behaviors With Contextual Element Observed Before Aberrant Driving Behaviors|"Collected contextual elements were :~Disorders in the institution (with a caregiver, frustration with the rules)~Difficulty / frustration with an inmate~Difficulty / frustration with the entourage~Consumption of alcohol or other toxic substances~Steps in the judicial process (refusal of parole, reduction of sentence ...)~Psychiatric symptoms: delirious, sleep disorders, nightmares The numerator for the percentage calculated is the number of aberrant driving behaviors with contextual element.~The denominator for the percentage calculated is the total number of aberrant driving behaviors (with and without contextual element)"|6 months||||percent of aberrant driving behaviors|Number of aberrant driving behaviors|95% Confidence Interval|Number
1312928|NCT02493088|Primary|The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors.||6 months||||participants|||Number
1316383|NCT02393209|Secondary|Overall Survival (OS) in Phase 2|Overall survival is defined as the time from the date of randomization to the date of death.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
1312929|NCT02493036|Primary|Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose.||56 days|In this table, there are 16, 18 and 14 subjects in the 42mg/42mg, 21mg/42mg and Placebo/42mg group, respectively. This is a change-from-baseline analysis, only subjects with no missing values AT BOTH baseline and Day 56 are included in the analysis, so the number of subjects in each group is less than the number of subjects that started the study.|||ppm*hr||Standard Deviation|Mean
1312930|NCT02492984|Secondary|Number of Confirmed LETE in the Low Recovery Setting|LETE could also be lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. The only confounding factors for low recovery were: known presence or subsequent identification of a FVIII inhibitor; known compromised Xyntha; faulty administration of Xyntha, including inadequate dosing.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||LETE bleeds|||Number
1312931|NCT02492984|Secondary|Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting|LETE occurred in the on-demand setting if 2 successive “No Response” ratings were recorded after 2 successive Xyntha drug infusions, respectively.The infusions must have been administered within 24 hours (less than or equal to 24 hours) of each other for treatment of the same bleeding event in the absence of confounding factors (prespecified). Therefore, LETE in the on-demand setting was based on the response to treatment of a bleeding episode (including those occurring during the surgical prophylaxis period). Note that on-demand treatments administered during the surgical prophylaxis period were also to be included.|From Day 1 up to participants had received treatment for 6 months or participants had achieved 50 EDs whichever occurred first.|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||percentage of bleeding episodes|bleeding episodes|95% Confidence Interval|Number
1312932|NCT02492984|Secondary|Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment|The total amount (IU) infused for each Xyntha infusion recorded in the study drug infusion log case report form (CRF) was summed to calculate the total factor VIII consumption for each participant. The average infusion dose for each participant was calculated as his total factor VIII consumption (in IU) divided by the number of infusions administered. The total factor VIII consumption, divided by number of infusions, was summarized similarly to average infusion dose (IU).|On-Demand Group: Day 1 up to 6 months or 50 EDs whichever occurred first. Surgical Prophylaxis Group: Day of surgery to postoperative period. The duration of postoperative period is specified in previous endpoints.|All participants who received at least one dose of Xyntha during the study|||International Unit (IU)||Standard Deviation|Mean
1312933|NCT02492984|Secondary|Number of Participants With Transfusion Requirement for Surgical Prophylaxis Treatment|Number of participants with transfusion requirement for surgical prophylaxis treatment. Transfusion requirements during the intraoperative and the postoperative period were assessed by investigator or surgeon. The number of units and types of blood products transfused were recorded if applicable.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group."|||participants|||Number
1312934|NCT02492984|Secondary|Actual Estimated Blood Loss for Surgical Prophylaxis Treatment|Number of participants with blood loss in each category (Abnormal, Normal, and Absence). Blood loss during the intraoperative and the postoperative period were assessed by investigator or surgeon, which were rated as Abnormal, Normal, and Absence. Abnormal blood loss meant the blood loss was higher over the expectation for the non hemophilic participant.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group. Number of participants analyzed signifies participants evaluable for this outcome measure."|||partcipants|||Number
1312935|NCT02492984|Secondary|Hemostatic Efficacy for Surgical Prophylaxis Treatment|Assessment of hemostatic efficacy was determined by the investigator and/or surgeon using the 4 point Surgical Hemostasis Efficacy Rating Scale. Excellent: Achieved hemostasis comparable to that expected after similar surgery in a non hemophilic participant. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non hemophilic participant. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. No Response: No hemostatic response. The percentage of observations in each hemostatic efficacy response category (excellent, good, moderate, none) was reported.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group."|||percentage of observations|||Number
1312936|NCT02492984|Secondary|Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group|The number of bleeds resolved with 1, 2, 3, 4, or >4 infusions was reported for each of the categories (1, 2, 3, 4, or >4 infusions needed to treat the bleed), in which the numerator was the number of bleeds falling into each category, and the denominator was the total number of new bleeds across all participants.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."|||percentage of bleeds|bleeds||Number
1312964|NCT02492763|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12|This change from baseline reflects the Week 12 DBP minus the Week 0 DBP.|Baseline and Week 12|All randomized, treated participants with at least one DBP measurement (baseline or post-baseline).|||mmHg||95% Confidence Interval|Least Squares Mean
1312965|NCT02492763|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12|This change from baseline reflects the Week 12 SBP minus the Week 0 SBP.|Baseline and Week 12|All randomized, treated participants with at least one SBP measurement (baseline or post-baseline).|||mmHg||95% Confidence Interval|Least Squares Mean
1312937|NCT02492984|Secondary|Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment|The number of Xyntha infusions administered to treat a bleed was determined. This was calculated by adding the on-demand initial treatment and any on-demand follow-up infusions for the same bleed (same bleed start date/time).|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."|||infusions||Standard Deviation|Mean
1312938|NCT02492984|Secondary|Response Assessment of On-Demand Treatment of Bleeds|The proportion of infusions (initial and subsequent for a bleed) in each response category (excellent, good, moderate, no response) was reported. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No Response: No improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsens.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."|||percentage of infusions|infusions||Number
1312939|NCT02492984|Secondary|Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.|From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first).|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||participants|||Number
1312940|NCT02492984|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitors|Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).|From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||percentage of participants||95% Confidence Interval|Number
1312941|NCT02492958|Secondary|Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3|GMFR of anti–Staphylococcus aureus FBI for ClfA was computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Fold rise||95% Confidence Interval|Geometric Mean
1312942|NCT02492958|Secondary|Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3|GMFRs of anti–Staphylococcus aureus OPA for CP5 and CP8 were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.|Baseline, Day 11, 15, 29 and Month 3|"The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies number of participants who were evaluable for specific antigens for each arm, respectively."|||Fold rise||95% Confidence Interval|Geometric Mean
1312943|NCT02492958|Secondary|Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3|GMFRs of anti–Staphylococcus aureus cLIA for ClfA and MntC were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Fold rise||95% Confidence Interval|Geometric Mean
1312944|NCT02492958|Secondary|Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)|Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by FBI for ClfA and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Titer||95% Confidence Interval|Geometric Mean
1312966|NCT02492763|Secondary|Change From Baseline in Fasting Triglycerides at Week 12|This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides.|Baseline and Week 12|All randomized, treated participants with at least one fasting triglycerides measurement (baseline or post-baseline).|||mg/dL||Standard Deviation|Mean
1312945|NCT02492958|Secondary|Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)|Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by OPA for CP5 and CP8 and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.|Baseline, Day 11, 15, 29 and Month 3|"The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies number of participants who were evaluable for specific antigens for each arm, respectively."|||Titer||95% Confidence Interval|Geometric Mean
1312946|NCT02492958|Secondary|Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)|Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by cLIA for ClfA and MntC and corresponding 2-sided 95 percent (%) confidence intervals (CIs) were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Titer||95% Confidence Interval|Geometric Mean
1312947|NCT02492958|Secondary|Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3|Percentage of participants achieving predefined antibody response to CP5, CP8, ClfA and MntC at Baseline, Day 11, 15 and Month 3 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on OPA assay for CP5 and CP8, respectively; was 121 based on FBI assay for ClfA, 512 based on cLIA for MntC.|Baseline, Day 11, 15 and Month3|"The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies the number of participants who were evaluable for specific antigens for each arm, respectively."|||Percentage of participants||95% Confidence Interval|Number
1312948|NCT02492958|Primary|Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29|Percentage of participants achieving predefined antibody response to capsular polysaccharide serotype 5 (CP5), capsular polysaccharide serotype 8 (CP8), clumping factor A (ClfA) and manganese transporter C (MntC) at Day 29 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on opsonophagocytic activity (OPA) assay for CP5 and CP8, respectively; was 121 based on fibrinogen-binding inhibition (FBI) assay for ClfA and 512 based on competitive Luminex immunoassay (cLIA) for MntC.|Day 29|"The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies the number of participants who were evaluable for specific antigens for each arm, respectively."|||Percentage of participants||95% Confidence Interval|Number
1312949|NCT02492958|Primary|Percentage of Participants With Blood Chemistry Abnormalities at Day 15|Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.|Day 15|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1312950|NCT02492958|Primary|Percentage of Participants With Blood Chemistry Abnormalities at Day 5|Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.|Day 5|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1312951|NCT02492958|Primary|Percentage of Participants With Coagulation Abnormalities at Day 15|Coagulation analysis included the following parameters: PT, APTT, platelet AGG with ADP, platelet AGG with arachidonic acid, platelet AGG with collagen and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.|Day 15|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1312952|NCT02492958|Primary|Percentage of Participants With Coagulation Abnormalities at Day 5|Coagulation analysis included the following parameters: prothrombin time (PT), activated partial thromboplastin time (APTT), platelet aggregation (AGG) (with adenosine diphosphate [ADP], with arachidonic acid, and with collagen) and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.|Day 5|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1312967|NCT02492763|Secondary|Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12|This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol.|Baseline and Week 12|All randomized, treated participants with at least one fasting HDL cholesterol measurement (baseline or post-baseline).|||mg/dL||Standard Deviation|Mean
1312953|NCT02492958|Primary|Percentage of Participants With Hematology Abnormalities at Day 15|Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.|Day 15|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1312954|NCT02492958|Primary|Percentage of Participants With Hematology Abnormalities at Day 5|Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.|Day 5|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here ‘number of participants analyzed (N)’ signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1312955|NCT02492958|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or deemed medically significant for any other reason. A treatment emergent AE was defined as an event that emerged during the study that was absent before administration of investigational product, or worsened relative to the pre-administration state. AEs reported during this time period included both SAEs and newly diagnosed chronic medical disorders (NDCMD). A NDCMD was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|After Day 29 up to Month 12|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants|||Number
1312956|NCT02492958|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious AEs. Treatment-emergent AEs were events between the administration of investigational product and up to Day 29 that were absent before vaccination or that worsened relative to pre-administration state.|Day 1 up to Day 29|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants|||Number
1312957|NCT02492958|Primary|Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
1312958|NCT02492958|Primary|Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). In this outcome measure percentage of participants with any systemic event was reported.|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
1312959|NCT02492958|Primary|Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination|Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (5.5 to 10.0 cm) and, severe (>=10.5 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
1312960|NCT02492958|Primary|Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination|Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were defined as mild (2.5 to 5.0 centimeters [cm]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to [>=] 10.5 cm). Pain at injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). In this outcome measure percentage of participants with any local reaction was reported.|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
1312961|NCT02492880|Primary|Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire|Change in paresthesia distribution based on programming parameters|minimum 25 days post IPG implant||||Participants|||Count of Participants
1312968|NCT02492763|Secondary|Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12|This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol.|Baseline and Week 12|All randomized, treated participants with at least one fasting LDL cholesterol measurement (baseline or post-baseline).|||mg/dL||Standard Deviation|Mean
1312969|NCT02492763|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|This change from baseline reflects the Week 12 FPG minus the Week 0 FPG.|Baseline and Week 12|All randomized, treated participants with at least one FPG measurement (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
1312970|NCT02492763|Secondary|Change From Baseline in Body Weight at Week 12|This change from baseline reflects the Week 12 body weight minus the Week 0 body weight.|Baseline and Week 12|All randomized, treated participants with at least one body weight measurement (baseline or post-baseline).|||Kilograms||95% Confidence Interval|Least Squares Mean
1312971|NCT02492763|Primary|Change From Baseline in Heart Rate at Week 12|This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate.|Baseline and Week 12|All randomized, treated participants with at least one heart rate measurement (baseline or post-baseline).|||Beats/minute||95% Confidence Interval|Least Squares Mean
1312972|NCT02492763|Primary|Number of Participants With an AE of Symptomatic Hypoglycemia|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events.|Up to Week 14|All randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1312973|NCT02492763|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 12|All randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1312974|NCT02492763|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 14|All randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1312975|NCT02492763|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 12|A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C.|Baseline and Week 12|All randomized, treated participants with at least one A1C measurement (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
1312976|NCT02492451|Primary|Pregnancy Rate|ongoing pregnancy rates|12 weeks||||percentage of ongoing pregnancies|||Number
1312977|NCT02492165|Primary|Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
1312978|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1312979|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1312980|NCT02492165|Primary|Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|"Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia.~Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years).~Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity."|Day 0 up to Day 14 post-vaccination|Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1313044|NCT02491411|Primary|PSA Response Rate|PSA response rate is defined as the proportion of subjects with a >= 50% PSA decline from baseline level when starting enzalutamide and maintained for >= 4 weeks at any time-point after receiving enzalutamide. Will determine its corresponding 95% confidence interval.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
1312981|NCT02491944|Secondary|CL for [14C]AZD9291|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of total body clearance of drug from plasma after intravascular administration (CL) for [14C]AZD9291.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||L/h||Standard Deviation|Mean
1312982|NCT02491944|Secondary|t1/2,λz for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the elimination half life (t1/2,λz) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Standard Deviation|Mean
1312983|NCT02491944|Secondary|Tmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the the time to maximum observed plasma concentration (Tmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Full Range|Median
1312984|NCT02491944|Secondary|Cmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq||Geometric Coefficient of Variation|Geometric Mean
1312985|NCT02491944|Secondary|AUC(0-t) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
1312986|NCT02491944|Secondary|AUC(0-120) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
1312987|NCT02491944|Secondary|AUC(0-24) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
1312988|NCT02491944|Secondary|AUC for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
1312989|NCT02491944|Secondary|CL/F for AZD9291|PK profile of the oral dose of AZD9291 in terms of apparent total body clearance of drug from plasma after extravascular administration(CL/F) for AZD9291.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||L/h||Standard Deviation|Mean
1313050|NCT02490670|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose||Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.|||Microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1312990|NCT02491944|Secondary|t1/2,λz for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the elimination half life (t1/2,λz) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Standard Deviation|Mean
1312991|NCT02491944|Secondary|Tmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the time to maximum observed plasma concentration (Tmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Full Range|Median
1312992|NCT02491944|Secondary|Cmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM||Geometric Coefficient of Variation|Geometric Mean
1312993|NCT02491944|Secondary|AUC(0-t) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1312994|NCT02491944|Secondary|AUC(0-120) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1312995|NCT02491944|Secondary|AUC(0-24) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1312996|NCT02491944|Secondary|AUC for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1312997|NCT02491944|Primary|Absolute Oral Bioavailability|Absolute bioavailability of AZD9291 will be calculated from area under the plasma concentration versus time curve (AUC) of the oral dose of AZD9291 / AUC of the IV dose of [14C]AZD9291 x IV dose/Oral dose x 100|Samples taken at pre-dose, 1, 2, 3, 4, 5:45, 5:52, 6, 6:05, 6:10, 6:20, 6:25, 6:30, 7, 8, 9, 10, 12, 14, 16, 18, 24, 30, 48, 72, 120, 168, 216, 336 and 504 hours relative to the oral dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||Percentage||90% Confidence Interval|Geometric Mean
1312998|NCT02491892|Secondary|Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%|Echocardiography was performed to determine LVEF, defined as the volume of blood pumped from the left ventricle as a percentage of end-diastolic volume. Theoretically, LVEF may range from 0 to 100%. The number of participants experiencing a drop in LVEF greater than or equal to (≥) 10 or 15 percentage points to a final LVEF of less than (<) 50% is reported here.|Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion)|Safety Population.|||participants|||Number
1312999|NCT02491892|Secondary|Mean Residence Time (MRT) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the MRT by non-compartmental analysis. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||days||Standard Deviation|Mean
1313000|NCT02491892|Secondary|Volume of Distribution at Steady State (Vss) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the Vss by non-compartmental analysis, defined as the theoretical volume at which the total amount of pertuzumab would be uniformly distributed to produce the desired concentration. The derived value was averaged among all participants and expressed in milliliters (mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||mL||Standard Deviation|Mean
1313001|NCT02491892|Secondary|Systemic Clearance (CL) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine CL by non-compartmental analysis, defined as the rate at which pertuzumab was removed from the body. The derived value was averaged among all participants and expressed in milliliters per day (mL/day).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||mL/day||Standard Deviation|Mean
1313002|NCT02491892|Secondary|Area Under the Concentration-Time Curve (AUC) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine AUC to the last measurable observation (AUClast) and AUC extrapolated to infinity (AUCinf) by non-compartmental analysis. The derived values were averaged among all participants and expressed in days by micrograms per milliliter (days*mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis, and the number of participants analyzed (n) is presented here.|||days*mcg/mL||Standard Deviation|Mean
1313003|NCT02491892|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The time of maximum observed pertuzumab concentration across all collection points was documented. Tmax was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||days||Full Range|Median
1313004|NCT02491892|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The maximum observed pertuzumab concentration across all collection points was documented. Cmax was averaged among all participants and expressed in micrograms per milliliter (mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||mcg/mL||Standard Deviation|Mean
1313005|NCT02491892|Secondary|Apparent Half-Life (t1/2) of Pertuzumab|Serum samples were obtained for pharmacokinetic (PK) assessment using a receptor-binding, enzyme-linked immunosorbent assay (ELISA). Pertuzumab concentrations at each collection point were used to determine the apparent t1/2 by non-compartmental analysis, defined as the time elapsed for pertuzumab concentrations to decrease by 50%. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||days||Standard Deviation|Mean
1313006|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of SD|Objective tumor response was assessed using RECIST. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD. The percentage of participants achieving a best overall response of SD was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
1313007|NCT02491892|Secondary|Overall Survival|Overall survival was defined as the time from treatment start to death. Participants who did not die during follow-up were to be censored from the last known alive date. Overall survival was to be estimated using Kaplan-Meier.|Up to approximately 2 years (from start of treatment until death)|Median survival was not reached because the study program was terminated early. Analysis of the incomplete data set was not performed because it could potentially produce skewed or statistically irrelevant data.||||||
1313008|NCT02491892|Secondary|Percentage of Participants Who Died|The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 2 years (from start of treatment until death)|Safety Population: All randomized participants who received at least one dose of pertuzumab and had at least one post-baseline safety assessment.|||percentage of participants|||Number
1313009|NCT02491892|Secondary|Time to Treatment Failure|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Time to treatment failure was defined as the time from treatment start to PD or early withdrawal from the study for death, toxicity, refusal/noncompliance, insufficient therapeutic response, or failure to return. Participants who did not experience PD or who did not withdraw from the study early were censored from the last tumor assessment. Time to treatment failure was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
1313010|NCT02491892|Secondary|Number of Participants Who Experienced PD or Withdrew From the Study Early|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||participants|||Number
1313011|NCT02491892|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
1329596|NCT02107014|Primary|Change in IP-10 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1313012|NCT02491892|Secondary|Number of Participants Who Experienced PD or Death|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||participants|||Number
1313013|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR) to PD or death. Participants who did not experience PD or death were to be censored from the last tumor assessment. Duration of response was to be estimated using Kaplan-Meier.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
1313014|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
1313015|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR or PR) to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Duration of response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
1313016|NCT02491892|Secondary|Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Time to response was defined as the time from treatment start to first documented response (ie, CR or PR). Participants with stable disease (SD) were censored from the last tumor assessment, and those with progressive disease (PD) or death were assigned an artificial censoring time of 1000 days. Time to response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
1313017|NCT02491892|Primary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30 percent (%) decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
1313018|NCT02491463|Secondary|Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)|IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.|At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||B-cells/million cells||Inter-Quartile Range|Median
1313019|NCT02491463|Secondary|Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells|Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.|At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||T-cells/million cells||Inter-Quartile Range|Median
1313020|NCT02491463|Secondary|Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value|Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.|At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||Participants|||Count of Participants
1313045|NCT02491073|Secondary|Comparison of Concentrations of TSH,as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||mU/L||Geometric Coefficient of Variation|Geometric Mean
1313021|NCT02491463|Secondary|Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers|Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).|At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1313022|NCT02491463|Secondary|Number of Subjects With Haematological and Biochemical Results by Maximum Grade|Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 360, for the same parameter, e.g. ALT G0-G2.|From Day 1 up to Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
1313023|NCT02491463|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
1313024|NCT02491463|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
1313025|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Results by Maximum Grade|Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.|From Day 1 to Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
1313026|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).|At Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 360.|||Participants|||Count of Participants
1313027|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).|At Day 180|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 180.|||Participants|||Count of Participants
1313046|NCT02491073|Secondary|Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313047|NCT02491073|Secondary|Comparison of Concentrations of TT4, and TT3 as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||nmo/L||Geometric Coefficient of Variation|Geometric Mean
1313028|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).|At Day 60|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 60.|||Participants|||Count of Participants
1313029|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).|At Day 37|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 37.|||Participants|||Count of Participants
1313030|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).|At Day 33|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 33.|||Participants|||Count of Participants
1313031|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).|At Day 31|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 31.|||Participants|||Count of Participants
1313032|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).|At Day 30|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 30.|||Participants|||Count of Participants
1313048|NCT02491073|Primary|Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by Automated Kit Assay in Non-ESL Exposed Subjects, With and Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313049|NCT02491073|Primary|Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313033|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).|At Day 7|The analysis was performed on the Total Vaccinated cohort which which included all subjects with at least one study vaccine administration documented and with available results at Day 7.|||Participants|||Count of Participants
1313034|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).|At Day 3|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 3.|||Participants|||Count of Participants
1313035|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)|At Day 1|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 1.|||Participants|||Count of Participants
1313036|NCT02491463|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
1313037|NCT02491463|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
1313038|NCT02491411|Secondary|Time to Radiographic Progression for Treatment With Dexamethasone|Will be summarized using Kaplan-Meier approach.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
1313039|NCT02491411|Secondary|Time to PSA Progression, Based Upon PCWG2 Criteria, for Treatment With Dexamethasone|Will be summarized using Kaplan-Meier approach.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
1313040|NCT02491411|Secondary|Response Rate With Enzalutamide by AR-V7 Status at Study Entry||Baseline|Data was not collected, the study was terminated early due to lower enrollment.||||||
1313041|NCT02491411|Secondary|Response Rate With Dexamethasone by AR-V7 Status at Study Entry||Baseline|Data was not collected, the study was terminated early due to lower enrollment.||||||
1313042|NCT02491411|Secondary|Objective Response Rate to Enzalutamide in Patients With Measurable Disease on CT Scan|Will estimate 95% confidence interval.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
1313043|NCT02491411|Secondary|Changes in Quality of Life Assessment Scores, Assessed Using FACIT-Fatigue Scale and RANDSF-36 Surveys|Summary statistics of the scores will be reported at baseline before starting dexamethasone and each follow-up time during the treatment of dexamethasone and enzalutamide. Changes in quality of life scores over the course of the study will be computed and their significance will be evaluated by paired-sample t-tests.|Baseline to up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
1316670|NCT02387710|Primary|Apnea Hypopnea Index (AHI)|Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.|1 night||||events/hour||Inter-Quartile Range|Median
1313051|NCT02490670|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose||Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.|||hour*microgram per milliliter (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1313052|NCT02490475|Secondary|Number of Participants With DLTs|DLTs were defined as any of the following: 1) Any non-hematological toxicity greter than or equal to (≥) Grade 3 according t0 CTCAE version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From Baseline until 4 weeks after the end of treatment|Safety Population|||number of participants|||Number
1313053|NCT02490475|Secondary|CL for Docetaxel Alone and in Combination With Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per hour per meter squared (mL/h/m^2). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||mL/h/m^2||Standard Deviation|Mean
1313054|NCT02490475|Secondary|Vss for Docetaxel Alone and in Combination With Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||mL/m^2||Standard Deviation|Mean
1313055|NCT02490475|Secondary|AUC(0-∞) for Docetaxel Alone and in Combination With Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as ng*h/mL. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||ng*h/mL||Standard Deviation|Mean
1313056|NCT02490475|Secondary|Cmax for Docetaxel Alone and in Combination With Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||ng/mL||Standard Deviation|Mean
1313057|NCT02490475|Secondary|Tmax for Docetaxel Alone and in Combination With Pertuzumab|"Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. When the rate of absorption equals the rate of elimination. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||days||Full Range|Median
1313058|NCT02490475|Secondary|t1/2 for Docetaxel Alone and in Combination With Pertuzumab|"The biological half-life or terminal half-life of docetaxel is the time in hours it takes for it to lose half of its pharmacologic activity. Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||days||Full Range|Median
1313059|NCT02490475|Secondary|Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) by Category of Decrease and Timepoint|Ejection fraction (EF) is the fraction of outbound blood pumped from the heart with each heartbeat. It is commonly measured by echocardiogram and serves as a general measure of a person's cardiac function. Changes in LVEF were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. The decrease in LVEF has been categorized as follows: A) Increase, no change, decrease from baseline less than (<) 10%; B) Absolute value <50% and decrease from baseline greater than or equal to (≥) 10%; C) Absolute value <50% and decrease from baseline≥15% ; D) Other. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Baseline, Weeks 7(Cycle 2), 13 (Cycle 4) and Final Visit Up to Week 22|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm, respectively.|||percentage of participants|||Number
1313060|NCT02490475|Secondary|Percentage of Participants by Best Overall Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Best Overall response was evaluated as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). CR: complete disappearance of all target lesions. PR: at least a 30 percent (%) decrease in the sum of the longest diameters. SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameters since the treatment started. PD: at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Weeks 7 (Cycle 2),13 (Cycle 4) and Final Visit Up to 22 weeks|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm respectively.|||percentage of participants|||Number
1313061|NCT02490475|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||days||Standard Deviation|Mean
1313062|NCT02490475|Secondary|Volume of Distribution (Vz) at Steady State of Pertuzumab in Combination With Docetaxel|The volume of distribution at steady state (Vz), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||mL||Standard Deviation|Mean
1313063|NCT02490475|Secondary|Clearance (Cl) of Pertuzimab in Combination With Docetaxel|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||mL/day||Standard Deviation|Mean
1313064|NCT02490475|Secondary|AUC From Time Zero to Infinity (AUC [0-infinity]) for Pertuzumab in Combination With Docetaxel|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as μg*day/mL.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||μg*day/mL||Standard Deviation|Mean
1313065|NCT02490475|Secondary|Area Under the Concentration Curve From Time Zero to the Last Visit (AUC [0-last]) for Pertuzumab in Combination With Docetaxel|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (μg*day/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||μg*day/mL||Standard Deviation|Mean
1313066|NCT02490475|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pertuzumab in Combination With Docetaxel|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as micrograms per milliliter (μg/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. n = number of participants analyzed at the specified timepoint for each arm, respectively.|||μg/mL||Standard Deviation|Mean
1313067|NCT02490475|Secondary|Plasma Decay Half Life (t1/2) for Pertuzumab in Combination With Docetaxel|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. number (n) equals (=) number of participants analyzed at the specified timepoint for each arm, respectively.|||days||Full Range|Median
1313082|NCT02489500|Secondary|Overall Survival|duration of overall survival measured in months|5 years|Two patients expired just over a month following transplant. The protocol was closed prior to the 5-year period of assessment, so 5-year survival assessment of only two participants was assessed.|||months|||Number
1313083|NCT02489500|Secondary|Toxicities|Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|100 days||||events per participant||Full Range|Mean
1313084|NCT02489500|Primary|Number of Participants With Hematologic Response|Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains|6 months|Two participants were not evaluable as they expired and did not have a post-treatment response evaluation.|||Participants|||Count of Participants
1313068|NCT02490475|Primary|Maximum Tolerated Dose (MTD) of Docetaxel in Combination of Pertuzumab|A prior dose level was defined as an MTD if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs). If there were no DLTs or DLTs were seen in less than (<) 2 participants in the highest dose level, that was considered as MTD. Participants received escalating doses of docetaxel and pertuzumab until DLTs were observed. DLTs were defined as any of the following: 1) Any non-hematological toxicity ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|Cycle 1 Up to Day 15|Safety Population: included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.|||mg/m^2|||Number
1313069|NCT02490293|Secondary|Duration of Hospitalization|the duration between the operation day and the day of discharge|participants will be followed for the duration of hospital stay, an expected average of 2 days||||days||Standard Deviation|Mean
1313070|NCT02490293|Primary|Number of Participants With Infectious Postoperative Complications|Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with antibiotics or placebo|30 days||||Participants|||Count of Participants
1313071|NCT02489799|Secondary|Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period|This tracks which participants report having had an advance care planning-related conversation with their surrogate decision maker.|Enrollment, one month after surgery|This question was only asked to participants who reported having designated a medical decision maker.|||Participants|||Count of Participants
1313072|NCT02489799|Secondary|Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period|This tracks which participants report having named a surrogate decision maker|Enrollment, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.|||Participants|||Count of Participants
1313073|NCT02489799|Secondary|Patient and Provider Satisfaction Scores Across Study Arms|The satisfaction score, as the sum of the scores of six questions (all in Likert scale), ranges from 6 to 30, with a higher score indicating higher level of satisfaction.|One week after enrollment|In two instances, the surgeon was unable to complete the satisfaction scale. This explains why there are fewer surgeon perceptions reported than patients.|||units on a scale||Standard Deviation|Mean
1313074|NCT02489799|Secondary|Recommendation of the Video to Others Across Study Arms|This Likert scale evaluates respondent beliefs about whether they would recommend the video to others.|One week after enrollment||||Participants|||Count of Participants
1313075|NCT02489799|Secondary|Comfort With the Video Across Study Arms|This Likert scale evaluates respondent beliefs about their comfort in viewing the video.|One week after enrollment||||Participants|||Count of Participants
1313076|NCT02489799|Secondary|Helpfulness of the Video Across Study Arms|This Likert scale evaluates respondent beliefs about the helpfulness of the video.|One week after enrollment||||Participants|||Count of Participants
1313077|NCT02489799|Secondary|Iowa Goals of Care Across Study Arms Throughout the Study Period|"This metric enables respondents to verify why they are seeking medical care. The most selected goal at all visits was Cure my medical condition. We have reported the number of participants in each group who selected this goal at each time point."|Enrollment, one week after enrollment, one week after surgery, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the Iowa Goals of Care questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.|||Participants|||Count of Participants
1313078|NCT02489799|Secondary|Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period|This validated metric consists of two sub scales: one for symptoms of anxiety, and the other for symptoms of depression. Each subscale, consisting of seven questions, results in a score ranging from 0, indicating no distress, to 21, indicating maximum distress; a score higher than 7 indicates clinically meaningful anxiety or depression. Overall HADS scores, encompassing both subscales, results in a total score of 0 (no mood symptoms ) to 42 (maximal mood symptoms).|Enrollment, one week after enrollment, one week after surgery, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.|||units on a scale||Standard Deviation|Mean
1313079|NCT02489799|Primary|Measured Patient Centeredness in the Presurgical Consent Visit|The RIAS scoring system using an audio-recording of a conversation to evaluate the nature of the conversation between surgeon and patient. The patient-centeredness summary score is a ratio of statements that reflect the psychosocial and socio-emotional elements of exchange about the lived illness experience of patients relative to statements that reflect a more biomedical and disease focused perspective. This score reflects the encounter as a whole, rather than an individual’s dialogue. A value greater than one indicates a more patient-centered encounter; whereas, a value less than one indicates a more biomedical encounter.|Approximately one week after study enrollment.|Audio recordings of a presurgical consent visit conversation between a surgeon and patient.|||Patient Centeredness Score|Audio Recordings|Standard Deviation|Mean
1313080|NCT02489799|Primary|Measured ACP Content in the Presurgical Consent Visit|The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.|Approximately one week after study enrollment.|Of note, the sample size is smaller for this outcome as our study did not collect recordings for all participants enrolled at the baseline visit. The reasons we did not collect the recordings include scheduling of emergent surgery without time to record, human and technology error, and patient preference.|||Recordings|Recordings||Count of Units
1313081|NCT02489500|Secondary|Number of Participants With Organ Response|analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver.|5 years|Due to early termination, organ response data was not collected.||||||
1313087|NCT02488980|Secondary|Protective Efficacy Based on Two Consecutive Positive Smears|Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. Analysis was based on a calculation of protective efficacy (PE) of tefaenoquine, defined as (1-relative risk of developing parasitaemia tafenoquine: placebo) x100% and 95.5% confidence intervals were constructed for the relative risk using Koopman's method.|24 Weeks||||Percentage of Protective Efficacy||95% Confidence Interval|Number
1313088|NCT02488980|Primary|Prophylactic Outcome Defined by the Subject Having no Positive Smears|Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.|24 Weeks||||participants|||Number
1313089|NCT02488915|Post-Hoc|Proportion of Subjects With New Territory Embolisation|Embolisation of any new territories was recorded directly post-treatment.|Post-treatment||||Participants|||Count of Participants
1313090|NCT02488915|Secondary|Time to Treat|"The time from first baseline angiogram to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.~mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:~mTICI 0 = No perfusion~mTICI 1 = Penetration but not perfusion~mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized~mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized~mTICI 2c = Near-complete perfusion~mTICI 3 = Complete perfusion"|Post-treatment||||minutes||Inter-Quartile Range|Median
1313091|NCT02488915|Secondary|Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory|Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)).|24(-8/+12) hours post-procedure||||Participants|||Count of Participants
1313092|NCT02488915|Secondary|Occurrence of Neurological Deterioration|An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.|24(-8/+12) hours post-procedure|Denominator exclude missing data. Participant who were not assessed for NIHSS at 24hrs and/or those who used rescue therapy at any time during the procedure were treated as missing data.|||Participants|||Count of Participants
1313093|NCT02488915|Secondary|Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)|sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention.|24(-8/+12) hours post-procedure||||Participants|||Count of Participants
1313094|NCT02488915|Secondary|Occurrence of Procedure Related Serious Adverse Events (PRSAE)|PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.|90(±14) days Post Procedure||||Participants|||Count of Participants
1313095|NCT02488915|Secondary|Occurrence of Serious Adverse Device Effects (SADE)|SADE was categorized as any serious adverse event that was deemed to be caused by the study device.|90(±14) days Post Procedure||||Participants|||Count of Participants
1313096|NCT02488915|Secondary|All-cause Mortality|Any death that occurs within 90(±14) days post-procedure.|90(±14) days Post Procedure|Denominator excludes missing data. Participants who were Lost to Follow-up and Withdrew Consent were treated as missing data.|||Participants|||Count of Participants
1313097|NCT02488915|Secondary|All Procedure-related Mortality|Any death that is deemed to have been caused by the study procedure.|Day 7 post-procedure||||Participants|||Count of Participants
1313098|NCT02488915|Secondary|Procedure Time|"The time from groin puncture to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.~mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:~mTICI 0 = No perfusion~mTICI 1 = Penetration but not perfusion~mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized~mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized~mTICI 2c = Near-complete perfusion~mTICI 3 = Complete perfusion"|Post-treatment||||minutes||Inter-Quartile Range|Median
1313099|NCT02488915|Secondary|Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2|"Good Clinical Outcome is defined as achieving an mRS score of ≤2 at 90 days post procedure.~mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6:~mRS 0 = No symptoms.~mRS 1 = No significant disability.~mRS 2 = Slight disability.~mRS 3 = Moderate disability.~mRS 4 = Moderately severe disability.~mRS 5 = Severe disability.~mRS 6 = Dead."|90(±14) days Post Procedure|All patients enrolled and treated with the EmboTrap device for whom there is known data, including those who were subsequently treated with other therapies. However, outcome data excludes cases where the patient withdrew consent or was lost to follow up, with undefined/unknown scores.|||Participants|||Count of Participants
1313100|NCT02488915|Primary|Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)|"The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH).~sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device."|24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure||||Participants|||Count of Participants
1313125|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|6 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1329597|NCT02107014|Primary|Change in SDF-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1313101|NCT02488915|Primary|Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)|"Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.)~mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:~mTICI 0 = No perfusion~mTICI 1 = Penetration but not perfusion~mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized~mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized~mTICI 2c = Near-complete perfusion~mTICI 3 = Complete perfusion"|Post-treatment|Analysis population includes all patients enrolled and treated with the EmboTrap device (N=227) irrespective of whether they met all incl/excl criteria.|||Participants|||Count of Participants
1313102|NCT02488681|Primary|Complications|Micra system and/or procedure-related complication rate|3 months post last follow up|All subjects who attempted Micra implant procedure|||% participants with complication||95% Confidence Interval|Number
1313103|NCT02488317|Primary|Preparation for Decision Making|Measured using Bennett, Carol, “Validation of a Preparation for Decision Making Scale.” Patient Education and Counseling 78, no. 1: 130–33 10 item scale, each item scored from 1 (not at all) to 5 (a great deal). items are summed and scored, converted to a 0-100 scale by subtracting 1 from the summed score and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making.|6 months|This was a comparison of the intervention group before and after using the decision aid to assess its impact on preparing the participant for decision making. The question was therefore not administered to the control group since a similar pre/post comparison could not be tested in this group that was not exposed to the intervention.|||units on a scale||Standard Deviation|Mean
1313104|NCT02488317|Primary|Knowledge|Measured using scale from Cavanaugh K“Patient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis.” Clinical Journal of the American Society of Nephrology 4, no. 5: 950–56) Multiple choice questions with one correct answer per questions. Number of correct questions reported as a percentage of total number of questions (23).|6 months|All participants who completed the questionnaire were included in these analyses.|||scores on a scale||Standard Deviation|Mean
1313105|NCT02488317|Primary|Decision Self-efficacy|"Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf O’Connor 1995 Items are scored 0(not at all confident) to 4 (very confident). Scores are summed across 10 items, divided by 10 and multiplied by 25. Scores range from 0-100. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy."|6 months|All participants who completed the questionnaire were included in these analyses.|||scores on a scale||Standard Deviation|Mean
1313106|NCT02488317|Primary|Decisional Conflict|Measured using the scale from O’Connor, Annette M. “Validation of a Decisional Conflict Scale.” Medical Decision Making 15, no. 1 (February 1, 1995): 25–30. 16 item scale, responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. Mean score per participant is calculated across all items, subtract by 1 and multiplied by 25. Score range= 0-100. Mean scores across all participants in each arm are reported.|6 months|All participants who completed the questionnaire were included in these analyses.|||scores on a scale||Standard Deviation|Mean
1313107|NCT02488317|Primary|Preference for Shared Decision Making|Measured using the scale from Degner, L. F., Sloan, J. A., & Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43. The CPS is a clinically relevant, easily administered, valid, and reliable measure of preferred roles in health-care decision-making. A pick-one approach was used to identify patient preference for an active, passive or collaborative role in dialysis treatment decision making.|6 months||||participants|||Number
1313108|NCT02488070|Secondary|Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan|Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.|an estimated average of 2 hours|The population analyzed included all participants receiving Ga-68 PSMA PET/CT or PET/MRI scan.|||participants|||Number
1313109|NCT02488070|Primary|Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)|Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.|||F/N ratio||Standard Deviation|Mean
1313110|NCT02488070|Primary|Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)|Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.|||F/N ratio||Standard Deviation|Mean
1313111|NCT02488070|Primary|Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution|The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.|||SUVmean||Standard Deviation|Mean
1313112|NCT02488070|Primary|Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution|The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.|||SUVmax||Standard Deviation|Mean
1313113|NCT02488018|Primary|Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects|Ten healthy individuals consumed monofloral honeys (25g of available carbohydrate in 250 mL water) after fasting for 11 hours. Blood glucose levels (mmol/L) were recorded at 0, 15, 30, 45, 60, 90 and 120 minutes. Time (0, 15, 30, 45, 60, 90 and 120 minutes) verse blood glucose levels (mmol/L) used to establish the area under the curve (AUC) for the honeys and reference glucose. This was used to calculate the glycemic index of honey each honey (GI= AUC for honey/AUC for reference glucose*100). All 10 participants took eight different honeys and reference glucose on nine different days (with randomized allocation of samples).|36 days (9 tests in 4 days interval)|All 10 participants took, 25g available carbohydrate of eight different honeys and reference glucose, on nine different days in 4 days interval. Blood was taken from finger prick using automatic lancet at 0, 15, 30, 45, 60, 90 and 120 minutes; glucose levels were recorded and area under the blood glucose curve was calculated.|||Index||Standard Deviation|Mean
1313114|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|6 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
1313115|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
1313116|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
1313117|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
1313118|NCT02487771|Post-Hoc|Anthropometrics: Body Composition|Child body composition was measured between 5 and 6 years of age by BOD POD air displacement plethysmography (COSMED, Concord, CA, USA). Methods adhered to standard testing protocol (tight-fitting one-piece swimsuit and swim cap, duplicate or triplicate measure of body volume and predicted thoracic gas volume). Fat and fat free mass to the nearest 0.1 kg are presented as means with standard deviations. Normative data are not available in this pediatric population.|5 to 5.5 years old|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313119|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
1313120|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|6 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313121|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313122|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313123|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313124|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313619|NCT02475031|Secondary|Average Pain Scores|Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged.|up to 60 hours||||units on a scale||Standard Error|Mean
1313126|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313127|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313128|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313129|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1313130|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|6 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313131|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|5.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313132|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313133|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|4.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313134|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|4 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313135|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|3.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1317263|NCT02368314|Secondary|Frequency of Strokes, Myocardial Infarction, Unstable Angina and Cardiovascular Death||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1313136|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|3 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313137|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|2.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313138|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian’s subjective assessment of the family’s ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|2 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
1313139|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|6 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313140|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313141|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313142|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313143|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|4 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313144|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|3.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313145|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|3 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313146|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|2.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313165|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|6 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313147|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|2 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313148|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|6 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313149|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313150|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313151|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313152|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|4 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313153|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|3.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313154|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|3 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313155|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|2.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
1313156|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|2 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m^2)||Standard Deviation|Mean
1313157|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|6 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313158|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313159|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313160|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313161|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|4 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313162|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|3.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313163|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|3 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313164|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|2.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313497|NCT02478164|Secondary|Progression-Free Survival (PFS)|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression or death. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria.|3 months||||days||95% Confidence Interval|Median
1313166|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|5.5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313167|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313168|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|4.5 years||||Kilogram (kg)||Standard Deviation|Mean
1313169|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|4 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313170|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|3.5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313171|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|2 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
1313172|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|3 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313173|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|2.5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313174|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|2 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
1313175|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|72 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
1313176|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|60 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
1313177|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|48 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
1313208|NCT02487199|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1313178|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child’s behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|36 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
1313179|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|72 Months|Missing data due to attrition, missed appointments, refusals, or questionable test|||units on a scale||Standard Deviation|Mean
1313180|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|48 Months|Missing data due to attrition, missed appointments, refusals, or questionable test|||units on a scale||Standard Deviation|Mean
1313181|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|36 Months|Missing data due to attrition, missed appointments, refusals, or questionable test|||units on a scale||Standard Deviation|Mean
1313182|NCT02487771|Primary|Cognitive Function Score - Test of Preschool Early Literacy|The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.|42 Months|Missing data due to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
1313183|NCT02487771|Primary|Cognitive Function Score - Peabody Picture Vocabulary Test|The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person’s receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.|60 Months|Missing data due to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
1313184|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|72 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
1313185|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|48 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
1313186|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child’s general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|36 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
1313187|NCT02487498|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30 min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1313498|NCT02478164|Secondary|Overall Survival (OS)|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.|2 years||||days||95% Confidence Interval|Median
1317264|NCT02368314|Secondary|Frequency of Heparin Induced Thrombocytopenia||During the treatment period (14 days)|||||||
1313188|NCT02487498|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis|||Liters||Standard Error|Least Squares Mean
1313189|NCT02487498|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.|baseline, 12 weeks|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
1313190|NCT02487498|Secondary|Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h.|baseline, 12 weeks|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis|||Liter||Standard Error|Least Squares Mean
1313191|NCT02487498|Secondary|Change From Baseline in FEV1 AUC 0-12h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h).|baseline, 0 to 12 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
1313192|NCT02487498|Secondary|Change From Baseline in FEV1 AUC 12-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h).|baseline, 12 hours to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
1313193|NCT02487498|Secondary|Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment.|baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1313194|NCT02487498|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
1313195|NCT02487498|Primary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1313196|NCT02487446|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liter||Standard Error|Least Squares Mean
1313197|NCT02487446|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liter||Standard Error|Least Squares Mean
1317265|NCT02368314|Secondary|Frequency of All Bleedings||During the treatment period (14 days)|||||||
1317266|NCT02368314|Secondary|Frequency of Other “Small” Bleedings||During the treatment period (14 days)|||||||
1313198|NCT02487446|Secondary|Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.|baseline, 15 minutes and 45 minutes pre morning dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liter||Standard Error|Least Squares Mean
1313199|NCT02487446|Secondary|Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h.|baseline, 12 weeks|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liter||Standard Error|Least Squares Mean
1313200|NCT02487446|Secondary|Change From Baseline in FEV1 AUC 0-12h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h).|baseline, 0 to 12 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liter||Standard Error|Least Squares Mean
1313201|NCT02487446|Secondary|Change From Baseline in FEV1 AUC 12-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h).|baseline, 12 hours to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1313202|NCT02487446|Secondary|Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment|baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1313203|NCT02487446|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1313204|NCT02487446|Primary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1313205|NCT02487199|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1313206|NCT02487199|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment.|12 weeks||||percentage of participants||95% Confidence Interval|Number
1313207|NCT02487199|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section.|Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks)|Safety population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1313672|NCT02473523|Other Pre-specified|Mean Change in Grip Strength|"A calibrated Jamar hydraulic hand dynamometer will be used to measure grip strength. Mean ± standard error will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313209|NCT02487030|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1313210|NCT02487030|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1313211|NCT02487030|Primary|Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)||12 weeks|Safety analysis Set|||percentage of participants|||Number
1313212|NCT02487030|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: all randomized or enrolled participants who had genotype 4 HCV infection and who took at least 1 dose of study drug.|||percentage of participants||99% Confidence Interval|Number
1313213|NCT02486952|Secondary|Percentage of Participants Who Were Alive|Percentage of participants with survival was calculated 41 months after the first dose of study treatment.|Up to 41 months|Full analysis population.|||percentage of participants|||Number
1313214|NCT02486952|Primary|Probability of Event Free Survival (EFS)|EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.|Up to 41 months|Full analysis population.|||probability of EFS||95% Confidence Interval|Number
1313215|NCT02486796|Secondary|Sedimentation Rate of Erythrocytes in Blood (mm/hr)|The erythrocyte sedimentation rate will be measured by approved methods.|Initial visit and study visits at 3-week intervals up to 4 months|Sedimentation rate was not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.|||mm/hr||Standard Deviation|Mean
1313216|NCT02486796|Secondary|Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)|The serum concentration of circulating tumor cells will be measured by approved methods.|Initial visit and study visits at 3-week intervals up to 4 months|Circulating tumor cells were not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.|||cells/ml||Standard Deviation|Mean
1313217|NCT02486796|Secondary|Concentration of C-reactive Protein in Serum (mg/L)|The serum concentration of C-reactive protein will be measured by approved methods.|Initial visit and study visits at 3-week intervals up to 4 months|C-reactive protein was not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.|||mg/dl||Standard Deviation|Mean
1313218|NCT02486796|Primary|Subject Reported Quality of Life Score|Subject quality of life as measured by a self-administered questionnaire (0 to 10 Likert scale with 0=No Effect to 10=Worst Effect) at each study visit. The symptoms or impact on activities scored included: Pain, Fatigue, Nausea, Sleep Disturbance, Distress, Shortness of Breath, Memory/Recall Problems, Appetite, Drowsiness, Dry Mouth, Sadness, Vomiting, Numbness, General Activities, Mood, Work, Relationships, Walking or Enjoyment.|Initial visit and study visits at 3-week intervals up to 4 months|One subject in the 'Delayed' arm withdrew consent following Study Visit 2. One subject in the 'Immediate' arm did not complete the Quality of Life Questionnaire at Visit 2. One subject in the 'Delayed' arm did not complete the Quality of Life Questionnaire at Visit 5. One subject in the 'Immediate' Arm withdrew consent prior to completing Visit 5.|||units on a scale||Standard Deviation|Mean
1313219|NCT02486627|Secondary|Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin)|PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.|Day 3|The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1313220|NCT02486627|Secondary|Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax)|PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.|Day 3|The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1313221|NCT02486627|Secondary|Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0–24h)|PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.|Day 3|The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.|||mg*h/L (milligrams times hour per liter)||Geometric Coefficient of Variation|Geometric Mean
1313222|NCT02486627|Secondary|Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.|Up to Day 32|The safety population included all randomized patients who received any amount of study drug.|||percentage of patients|||Number
1313223|NCT02486627|Secondary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at TOC|Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10^5 CFU/mL was reduced to <10^4 CFU/mL. Clinical Cure TOC: Complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure TOC: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI.|Day 17 TOC Visit|The ME (TOC) population consists of clinically evaluable patients with interpretable culture results at TOC, defined as one that has clearly identified pathogen(s) or one where baseline pathogen(s) could be excluded.|||percentage of patients|||Number
1313224|NCT02486627|Secondary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at Day 5|Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10^5 CFU/mL was reduced to <10^4 CFU/mL. Clinical Cure Day 5: Marked improvement defined as complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms develop. Failure Day 5: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; AE requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI.|Day 5|The ME (Day 5) population consists of clinically evaluable patients with interpretable culture results at Day 5, defined as one that has clearly identified pathogen(s) or one where baseline pathogen(s) could be excluded.|||percentage of patients|||Number
1313225|NCT02486627|Primary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC)|Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10^5 CFU/mL was reduced to <10^4 CFU/mL. Clinical Cure at TOC Visit: the complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason.|Day 17 TOC Visit|The mMITT Population consisted of all patients in the ITT Population who received any amount of study drug and had at least one qualified baseline pathogen from a study qualifying baseline urine culture against which meropenem and plazomicin have antibacterial activity.|||percentage of patients|||Number
1313226|NCT02486627|Primary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5|Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10^5 colony forming units per milliliter (CFU/mL) was reduced to <10^4 CFU/mL. Clinical Cure at Day 5: marked improvement evidenced by complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms developed. Failure: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; adverse event (AE) requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason.|Day 5|The mMITT Population consisted of all patients in the ITT Population who received any amount of study drug and had at least one qualified baseline pathogen from a study qualifying baseline urine culture against which meropenem and plazomicin have antibacterial activity.|||percentage of patients|||Number
1313227|NCT02485925|Secondary|Procedure Time, Ablation Time and Fluoroscopy Time|Procedure Time, Ablation Time and Fluoroscopy Time in minutes|1 day during procedure|Safety population|||Minutes||Standard Deviation|Mean
1313228|NCT02485925|Secondary|Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure|Percentage of subjects with PV reconnection after the first ablation|1 day during procedure|Safety population with pulmonary vein reconnection data available|||Percentage of participants||95% Confidence Interval|Number
1313229|NCT02485925|Secondary|Average Contact Force Per Pulmonary Vein Ablation Procedure|Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn’t have CF data|1 day during procedure|Safety population with contact force data available|||Grams||Standard Deviation|Mean
1313230|NCT02485925|Secondary|Percentage of Patients Where Acute Success Was Achieved|Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study.|0.5 hours|Safety Population, i.e., all enrolled subjects who undergone insertion of the study catheter during the procedure|||Percentage of participants||95% Confidence Interval|Number
1313231|NCT02485925|Primary|Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes|The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).|12 Months|Per protocol population: Subjects in the ITT Population who undergone insertion of the study catheter and AF ablation procedure, and had the 12th month primary efficacy endpoint data.|||Percentage of Participants||95% Confidence Interval|Number
1313232|NCT02485483|Primary|Percentage of Participants With Prevalence of Depressive Symptomatology Based on a BDI-II Score Greater Than or Equal to (≥)14 or PHQ-9 Score ≥5: VADERA II|PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a 9-item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27; with 0-4 indicating no depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. BDI-II Scale is a 21-item self-reported questionnaire measuring existence and severity of depression symptoms. Symptoms are each scored on a 4-point scale of 0 (no symptom) to 3 (severe symptom). Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe depression. Participants with a BDI-II score ≥14 or a PHQ-9 score ≥5 were classified as having depressive symptomatology. Participants were evaluated by positive depressive symptomatology for each questionnaire as well as being positive for both questionnaires combined or at least one of the questionnaires.|Baseline|Full analysis set of VADERA II population.|||percentage of participants||95% Confidence Interval|Number
1313233|NCT02485483|Primary|BDI-II Summary Score: VADERA II|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Full analysis set of VADERA II population. Number of participants analyzed = participants with BDI-II summary score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
1313234|NCT02485483|Primary|PHQ-9 Summary Score: VADERA II|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Full analysis set of VADERA II population defined as all study participants diagnosed with RA, who had given informed consent, and had completed at least one of the depression questionnaires. Number of participants analyzed = participants with PHQ-9 summary score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
1313235|NCT02485483|Primary|MADRS at Week 12 ± 2: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging between 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
1313236|NCT02485483|Primary|MADRS at Baseline: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging from 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at baseline.|||scores on a scale||Standard Deviation|Mean
1313237|NCT02485483|Primary|WHO-5 Index at Week 12 ± 2: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
1313238|NCT02485483|Primary|WHO-5 Index at Baseline: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
1313239|NCT02485483|Primary|BDI-II Score at Week 12 ± 2: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
1313240|NCT02485483|Primary|BDI-II Score at Baseline: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
1313241|NCT02485483|Primary|PHQ-9 Score at Week 12 ± 2: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with PHQ-9 score assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
1313256|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening.|||Percentage of participants|||Number
1313242|NCT02485483|Primary|PHQ-9 Score at Baseline: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Validation analysis set of VADERA I population defined as all study participants diagnosed with RA, who had given informed consent, and had no documented depression at baseline. Number of participants analyzed = participants with PHQ-9 score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
1313243|NCT02485353|Secondary|Procedure or Procedure Related Adverse Events|Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)|Up to 1 year|All patients enrolled and received treatment|||Participants|||Count of Participants
1313244|NCT02485353|Primary|Rate of Complete Remission|Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)|2 months|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||percentage of patients|||Number
1313245|NCT02485301|Secondary|Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies|A seronegative subject (S-) is a subject whose titer is below (<) 36.11 EU/mL. A seropositive subject (S+) is a subject whose titer is greater than or equal to (≥) 36.11 EU/mL.|At Day 0, Day 30, Month 6 and Month 12|The analysis was performed on the According-to-Protocol (ATP) cohort for Immunogenicity - AE and Humoral Immunity Sub-cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available.|||Percentage of participants|||Number
1313246|NCT02485301|Secondary|Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)|Anti-GP EBOV antibody concentrations were measured by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMC), and expressed in ELISA units per milliliter (EU/mL).|At Day 0, Day 30, Month 6 and Month 12|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity - AE and Humoral Immunity Sub-cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1313247|NCT02485301|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1313248|NCT02485301|Primary|Number of Subjects With Adverse Events of Specific Interest (AESI)|AESI included clinical symptoms of thrombocytopenia.|During the 7-Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1313249|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12.|||Percentage of participants|||Number
1313250|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint.|||Percentage of participants|||Number
1313251|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint.|||Percentage of participants|||Number
1313252|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6.|||Percentage of participants|||Number
1313253|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30.|||Percentage of participants|||Number
1313254|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6.|||Percentage of participants|||Number
1313255|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3.|||Percentage of participants|||Number
1313673|NCT02473523|Other Pre-specified|Median Change in Quadriceps Strength|"The Biodex System 3 Dynamometer will be utilized to measure isometric quadriceps muscle contractions. Median (range) will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313257|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12.|||Percentage of participants|||Number
1313258|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint.|||Percentage of participants|||Number
1313259|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint.|||Percentage of participants|||Number
1313260|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6.|||Percentage of participants|||Number
1313261|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30.|||Percentage of participants|||Number
1313262|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6.|||Percentage of participants|||Number
1313263|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3.|||Percentage of participants|||Number
1313264|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening.|||Percentage of participants|||Number
1313265|NCT02485301|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-Day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1313266|NCT02485301|Primary|Number of Subjects With Solicited General Adverse Events|Assessed solicited general adverse events were fatigue, fever [defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal (gastro) adverse events [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination. Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities. Grade 3 fever = fever ≥ 39.5 °C. Related = adverse event assessed by the investigator as related to the vaccination.|During the 7-Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
1313267|NCT02485301|Primary|Number of Subjects With Solicited Local Adverse Events|Assessed solicited local adverse events were pain, redness and swelling. Any = occurrence of any solicited local adverse event regardless of their intensity grade. Grade 3 Pain = significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site.|During the 7-Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - Adverse Event (AE) and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
1313268|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313269|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313270|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313271|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313272|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313273|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1317267|NCT02368314|Secondary|Frequency of Clinically Significant Bleedings||During the treatment period (14 days)|||||||
1313274|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313275|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313276|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313277|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313278|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313279|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313280|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313281|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
1313282|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase|"Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313674|NCT02473523|Other Pre-specified|Mean Change in Quadriceps Strength|"The Biodex System 3 Dynamometer will be utilized to measure isometric quadriceps muscle contractions. Mean ± standard error will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313283|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase|"Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313284|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0-120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313285|NCT02484911|Secondary|Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase|"Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313286|NCT02484911|Secondary|Proportion of Participants Receiving MEC With Complete Response in the Acute Phase|Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313287|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase|"Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313288|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue ）"|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313289|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313290|NCT02484911|Secondary|Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase|"Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313291|NCT02484911|Secondary|Proportion of Participants Receiving HEC With Complete Response in the Acute Phase|Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313292|NCT02484911|Primary|Proportion of Participants Receiving MEC With Complete Response in Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313293|NCT02484911|Primary|Proportion of Participants Receiving HEC With Complete Response in Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
1313294|NCT02484898|Primary|Diagnostic Yield of the SEEQ™ MCT/ECM System||120 Days|Subjects prescribed the SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias|||percentage of subjects with CRA||95% Confidence Interval|Number
1313295|NCT02484729|Secondary|Renal Clearance of Drug From Plasma [CLR (0-48)]|To assess urine pharmacokinetic parameters following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||L/h||Standard Deviation|Mean
1313296|NCT02484729|Secondary|Fraction Excreted Unchanged in Urine[Fe (0-48)]|To assess percentage of the total drug excreted in the urine that was unchanged following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||Percentage||Standard Deviation|Mean
1313297|NCT02484729|Secondary|Cumulative Amount of Unchanged Drug Excreted Into Urine [Ae (0-48)]|To assess urine pharmacokinetic parameters following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||nmol||Standard Deviation|Mean
1313298|NCT02484729|Secondary|Apparent Volume of Distribution (Vz/F)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||L||Standard Deviation|Mean
1313299|NCT02484729|Secondary|Apparent Clearance (CL/F)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||L/h||Standard Deviation|Mean
1313300|NCT02484729|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||Hour (h)||Standard Deviation|Mean
1313301|NCT02484729|Secondary|Time to Maximum Observed Plasma Concentration (t Max)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||Hour (h)||Full Range|Median
1313302|NCT02484729|Secondary|Observed Maximum Concentration (Cmax)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1313303|NCT02484729|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte concentrationAUC(0-t)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||h.nmol/L||Geometric Coefficient of Variation|Geometric Mean
1313304|NCT02484729|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Zero Extrapolated to Infinity.|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||h.nmol/L||Geometric Coefficient of Variation|Geometric Mean
1313305|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Urinalysis|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
1313306|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Clinical Chemistry|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
1313307|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Hematology|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
1313308|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Blood Pressure|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
1313309|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing the Number of Subjects With Adverse Events|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
1313310|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosing|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
1313311|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
1313312|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
1313313|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||percentage of participants|||Number
1313314|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in 24-hour 6-beta Hydroxycortisol Excretion at the End of the Six Week Treatment Period (Day 42).|The 24 hr urinary 6-beta hydroxycortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary 6-beta hydroxycortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary 6-beta hydroxycortisol excretion at Week 6 divided by the baseline 24-hr urinary 6-beta hydroxycortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed.|Baseline (Day 0) Day 42|The UC Population.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1313315|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in 24-hour Urinary Cortisol Excretion at the End of the Six Week Treatment Period (Day 42)|The 24 hr urinary cortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary cortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary cortisol excretion at Week 6 divided by the baseline 24-hr urinary cortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed.|Baseline (Day 0) Day 42|The Urinary Cortisol (UC) Population used consisted of all participants who did not have protocol violations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that affect the interpretation of the results.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1313316|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in Area Under the Curve (AUC) 0-24 Hour Serum Cortisol at the End of the Six Week Treatment Period (Day 42).|The blood samples for statistical analysis of area under the curve over the 24 hours (AUC 0-24 hours) endpoints were collected on Day 0 and Day 42 at the indicated time points. The AUC 0-24 hours was calculated using trapezoidal rule. Change from baseline in AUC 0-24 hour was calculated as a ratio from baseline defined as the AUC (0-24 hours) at Week 6 divided by the baseline AUC (0-24 hours) The ratio from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Par. with SC weighted mean (0-24hr) calculated at baseline and Week 6 were analyzed|Baseline and Week Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|The SC population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1313317|NCT02483975|Primary|Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (Day 42) in SC Population|The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D0 and D42 at indicated time points. The weighted mean was calculated by dividing the area under curve (AUC) over the 24-hr time period by time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from baseline defined as SC weighted mean (0-24 hrs) at Wk 6 divided by the baseline SC weighted mean (0-24 hrs). The ratio as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between Least square (LS) means. Using the pooled estimate of variance, 95% CIs) was calculated for the difference.|Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|SC Population consisted of all par. in the ITT pop who did not have protocol violations that considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors that would affect the interpretation of results. Par. with SC weighted mean (0-24 hr) calculated at baseline and Wk 6 were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1313331|NCT02483611|Secondary|HR - M6 (Heart Rate in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of heart rate was performed one minute after the tracheal intubation||||beats/min||Standard Deviation|Mean
1313675|NCT02473523|Other Pre-specified|Median Change in PedsQL Multidimensional Fatigue Scale|Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313318|NCT02483975|Primary|Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (D 42) in Intention-to-treat (ITT) Population|The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D 0 and D 42 at the indicated time points. The weighted mean was calculated by dividing the area under the curve (AUC) over the 24-hour (hr) time period by the time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from Baseline defined as the SC weighted mean (0-24 hours) at Week 6 divided by the Baseline SC weighted mean (0-24 hours).The ratio from Baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of Baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference.|Baseline, D 0 (Pre-dose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|ITT Population (pop) comprised of all randomized par. who received at least one dose of study medication. Randomized par. were assumed to have received study medication unless definitive evidence to the contrary exists. Par. with SC weighted mean (0-24 hr) calculated at Baseline and Week 6 were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1313319|NCT02483611|Secondary|HR - M7f (Heart Rate in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of heart rate was performed 90 minutes after the traqueal intubation||||beats/min||Inter-Quartile Range|Median
1313320|NCT02483611|Secondary|HR - M7e (Heart Rate in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of heart rate was performed 75 minutes after the traqueal intubation||||beats/min||Inter-Quartile Range|Median
1313321|NCT02483611|Secondary|HR - M7d (Heart Rate in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of heart rate was performed 60 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
1313322|NCT02483611|Secondary|HR - M7c (Heart Rate in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of heart rate was performed 45 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
1313323|NCT02483611|Secondary|HR - M7b (Heart Rate in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of heart rate was performed 30 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
1313324|NCT02483611|Secondary|HR - M7a (Heart Rate in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'.|This measure of heart rate was performed 15 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
1313325|NCT02483611|Secondary|MAP - M7f (Mean Arterial Pressure in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of average blood pressure was performed 90 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
1313326|NCT02483611|Secondary|MAP - M7e (Mean Arterial Pressure in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of average blood pressure was performed 75 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
1313327|NCT02483611|Secondary|MAP - M7d (Mean Arterial Pressure in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of average blood pressure was performed 60 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
1313328|NCT02483611|Secondary|MAP - M7c (Mean Arterial Pressure in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of average blood pressure was performed 45 minutes after the traqueal intubation||||mmHg||Standard Deviation|Mean
1313329|NCT02483611|Secondary|MAP - M7b (Mean Arterial Pressure in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of average blood pressure was performed 30 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
1313330|NCT02483611|Secondary|MAP - M7a (Mean Arterial Pressure in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'.|This measure of average blood pressure was performed 15 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
1313676|NCT02473523|Other Pre-specified|Mean Change in PedsQL Multidimensional Fatigue Scale|Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313332|NCT02483611|Secondary|HR - M5 (Heart Rate in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of heart rate was performed immediately before the tracheal intubation||||beats/min||Standard Deviation|Mean
1313333|NCT02483611|Secondary|HR - M4 (Heart Rate in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'.|This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)||||beats/min||Standard Deviation|Mean
1313334|NCT02483611|Secondary|HR - M3 (Heart Rate in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)||||beats/min||Standard Deviation|Mean
1313335|NCT02483611|Secondary|HR - M2 (Heart Rate in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of heart rate was performed immediately before induction of anesthesia||||beats/min||Standard Deviation|Mean
1313336|NCT02483611|Secondary|HR - M1 (Heart Rate in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of heart rate was performed when the patient arrived in the operating room||||beats/min||Standard Deviation|Mean
1313337|NCT02483611|Secondary|MAP - M6 (Mean Arterial Pressure in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of average blood pressure was performed one minute after the tracheal intubation||||mmHg||Inter-Quartile Range|Median
1313338|NCT02483611|Secondary|MAP - M5 (Mean Arterial Pressure in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of average blood pressure was performed immediately before the tracheal intubation||||mmHg||Inter-Quartile Range|Median
1313339|NCT02483611|Secondary|MAP - M4 (Mean Arterial Pressure in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'.|This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)||||mmHg||Inter-Quartile Range|Median
1313340|NCT02483611|Secondary|MAP - M3 (Mean Arterial Pressure in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)||||mmHg||Standard Deviation|Mean
1313341|NCT02483611|Secondary|MAP - M2 (Mean Arterial Pressure in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of average blood pressure was performed immediately before induction of anesthesia||||mmHg||Standard Deviation|Mean
1313342|NCT02483611|Secondary|MAP - M1 (Mean Arterial Pressure in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of average blood pressure was performed when the patient arrived in the operating room||||mmHg||Standard Deviation|Mean
1313343|NCT02483611|Primary|Spontaneous Recovery (T4/T1=90%)|"Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium.~This outcome measure was presented in minutes."|The participants were followed during the anesthetic - surgical procedure||||minutes||Standard Deviation|Mean
1313344|NCT02483611|Primary|Total Duration (Dur95%)|"The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium.~This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||minutes||Standard Deviation|Mean
1313345|NCT02483611|Primary|Final Recovery Index|"The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium.~This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||minutes||Standard Deviation|Mean
1313346|NCT02483611|Primary|Recovery Index|"The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium.~This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||minutes||Standard Deviation|Mean
1313347|NCT02483611|Primary|Clinical Duration|"The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium.~This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by Kruskal-Wallis test. When differences were found between the groups, we used the Dunn test for multiple comparisons (p value < 0.05)|||minutes||Inter-Quartile Range|Median
1313348|NCT02483611|Primary|Latency|"The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium.~This outcome meansure was presented in seconds."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||seconds||Standard Deviation|Mean
1313349|NCT02483585|Secondary|Number of Participants Who Developed Antibodies to Erenumab|"Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).~Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.~If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~Transient indicates a negative result at the participant's last time point tested, for those participants with a positive binding/neutralizing result post-baseline."|Baseline (the period prior to the first dose erenumab 70 mg) and post-baseline (the period after the first dose of erenumab 70 mg until 12 weeks after last dose, up to 48 weeks total)|Participants who received at least one dose of erenumab and with post-baseline data are included in the analysis.|||Participants|||Count of Participants
1313350|NCT02483585|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:~Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE."|From first dose of study drug up to 12 weeks after the last dose. The double-blind treatment phase was 12 weeks and the open-label treatment phase was 28 weeks.|For the double-blind treatment phase adverse events were analyzed for all randomized participants who received at least one dose of study drug. For the open-label treatment phase adverse events were analyzed for all participants who received at least one dose of study drug in the open-label treatment phase.|||Participants|||Count of Participants
1313351|NCT02483585|Secondary|Percentage of Participants With at Least a 5-Point Reduction From Baseline in Average Impact on Physical Impairment Domain Score Measured by MPFID at Week 12|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from “Without any difficulty” (1) to “Unable to do” (5) and frequency items ranging from “None of the time” (1) to “All of the time” (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 – 100, with higher scores representing greater impact of migraine.~Achievement of at least a 5 point reduction from baseline in the monthly average domain score was calculated as (monthly average domain score during the last 4 weeks of the 12-week double-blind treatment phase - baseline monthly average domain score) was ≤ -5."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on physical impairment domain score in the double-blind treatment phase. Participants with missing post-baseline data were counted as non-responders.|||percentage of participants|||Number
1313352|NCT02483585|Secondary|Percentage of Participants With at Least a 5-point Reduction From Baseline in Average Impact on Everyday Activities Domain Score Measured by MPFID at Week 12|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from “Without any difficulty” (1) to “Unable to do” (5) and frequency items ranging from “None of the time” (1) to “All of the time” (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 – 100, with higher scores representing greater impact of migraine.~Achievement of at least a 5 point reduction from baseline in the monthly average domain score was calculated as (monthly average domain score during the last 4 weeks of the 12-week double-blind treatment phase - baseline monthly average domain score) was ≤ -5."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on everyday activities domain score in the double-blind treatment phase. Participants with missing post-baseline data were counted as non-responders.|||percentage of participants|||Number
1313353|NCT02483585|Secondary|Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days at Week 12|"Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.~The change from baseline in monthly acute migraine-specific treatment days was calculated as the number of migraine-specific treatment days during the last 4 weeks of the 12-week double-blind treatment phase – the number of migraine-specific treatment days during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly acute migraine-specific treatment days in the double-blind treatment phase.|||acute migraine treatment days / month||Standard Error|Least Squares Mean
1313354|NCT02483585|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment.~At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase. Participants with missing data at week 12 were counted as non-responders.|||percentage of participants|||Number
1313355|NCT02483585|Primary|Change From Baseline in Monthly Migraine Days at Week 12|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase – the number of migraine days during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase.|||migraine days / month||Standard Error|Least Squares Mean
1313356|NCT02482935|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites||Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period|All participants who received abemaciclib and had evaluable plasma values.|||hours||Full Range|Median
1313357|NCT02482935|Primary|Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites||Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period|All participants who received abemaciclib and had evaluable plasma values.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1313358|NCT02482935|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites||Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period|All participants who received abemaciclib and had evaluable plasma values.|||nanograms x hours/mililiters (ng·h/mL)||Geometric Coefficient of Variation|Geometric Mean
1313359|NCT02482870|Secondary|Airway Complications|Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded.|The participants' will be followed for the duration of hospital stay, an expected average of 2 days||||participants|||Number
1313360|NCT02482870|Secondary|Cormack-Lehane Score|"Best Cormack-Lehane score (as declared by the laryngoscopist) obtained with both laryngoscopes is recorded.~Cormack-Lehane score is graded according to the following criteria (1 is best, and 4 is worst):~full view of glottis (difficult intubation unlikely)~partial view of glottis (~5% risk of difficult intubation)~partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)~neither glottis nor epiglottis seen (difficult intubation very likely)"|less than 24 hours||||participants|||Number
1313361|NCT02482870|Secondary|Glottic View Time|"Glottic view time (as defined when the laryngoscopist declared the best Cormack-Lehane score) with each laryngoscope is recorded.~Cormack-Lehane score is obtained by directly assessing the distance between the base of the tongue and the roof of the mouth to predict how diffcult an intubation will be.~It consists of 4 grades:~full view of glottis (difficult intubation unlikely)~partial view of glottis (~5% risk of difficult intubation)~partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)~neither glottis nor epiglottis seen (difficult intubation very likely)"|less than 24 hours||||seconds||Inter-Quartile Range|Median
1313362|NCT02482870|Secondary|Intubation Time|Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded.|less than 24 hours||||seconds||Inter-Quartile Range|Median
1313363|NCT02482870|Primary|Intubation Success Rate|Endotracheal intubation attempt is defined as entrance of the endotracheal tube into the patient's mouth. Any major change in the alignment of the laryngoscope is defined as another intubation attempt. Successful endotracheal intubation is defined as the endotracheal cuff passing through the patient's vocal cords. Intubation success rate is defined as: 1 / [the number of attempts].|less than 24 hours||||participants|||Number
1313364|NCT02482805|Primary|Salivary Testosterone Levels|Saliva sample taken before posture manipulation and 20 minutes after. Outcome is the change from pre- to post-manipulation in testosterone levels.|Baseline and 20 minutes after posture manipulation||||pg/mL||Standard Deviation|Mean
1313421|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose||First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1313365|NCT02482805|Primary|Subjective Units of Distress Scale (SUDs)|"Peak (max) SUDS ratings (0 to 100 scale) during treatment exposure and 1 week post-treatment exposure.~Peak Subjective Units of Distress Scale (SUDS) is the maximum amount of fear experienced rated on a 0 to 100 point scale, where 0 indicates no anxiety and 100 indicates the maximum level of anxiety."|Scores at 1 week post-treatment|8 individuals did not complete the post-treatment exposure; accordingly the analyses were conducted with only 66 individuals (versus the total sample size of 73) who had complete data.|||units on a scale||Standard Deviation|Mean
1313366|NCT02482805|Primary|LSAS-performance Subscale|"Liebowitz Social Anxiety Scale (LSAS)-Performance Subscale at pre- and 1-week post-treatment.~The Liebowitz Social Anxiety Scale (LSAS) - Performance Subscale is a subscale of a common measure of social anxiety symptom severity. This subscale consists of only 13 (of the total 24) items related to performance situations. Participants rate both their fear (0 to 3) and avoidance (0 to 3) of these 13 situations, where higher scores indicate worse social anxiety severity. The minimum possible score on this subscale is 0 and the maximum possible score is 78."|Scores at 1 week post-treatment|4 individuals did not complete LSAS at post-treatment; accordingly the analyses were conducted with only 69 individuals (versus the total sample size of 73) who had complete data.|||units on a scale||Standard Deviation|Mean
1313367|NCT02482571|Secondary|Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Hypoxia|Relative change in water signal intensity from rest to visual stimulation as measured by fMRS (without water suppression) in the primary visual cortex during conditions of hypoxia.|Baseline and Visual Stimulation at 30 seconds|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of signal intensity||Standard Deviation|Mean
1313368|NCT02482571|Secondary|Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Normoxia|Relative change in water signal intensity from rest to visual stimulation as measured by fMRS (without water suppression) in the primary visual cortex during conditions of normoxia.|Baseline and Visual Stimulation at 30 seconds|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of signal intensity||Standard Deviation|Mean
1313369|NCT02482571|Primary|Change in Glutamate Concentration During a Visual Stimulus Measured by Functional MRS at Hypoxia|Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of hypoxia.|Baseline and Visual Stimulation at 4 minutes|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of concentration (micromol/g)||Standard Deviation|Mean
1313370|NCT02482571|Primary|Change in Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia|Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of normoxia.|Baseline and Visual Stimulation at 4 minutes|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of concentration (micromol/g)||Standard Deviation|Mean
1313371|NCT02482428|Secondary|Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16|Number of Participants that had partial clearance rate of at least 75 percent reduction in External Genital Wart (EGW)s count at end of treatment (EOT) Week 12 or 16|End of Treatment (EOT) Week 12 or Week 16|Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
1313372|NCT02482428|Primary|Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks|Number of participants with at least one AE/SAE in the category up to 30 weeks|30 weeks|The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis.|||participants|||Number
1313373|NCT02482428|Primary|Complete Clearance of Disease at Week 14|Number of participants achieving complete clearance of genital warts at Week 14|Week 14|Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
1313374|NCT02482298|Other Pre-specified|Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events)|To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD|Baseline through Week 12|The Safety analysis set included all patients who received at least 1 single dose of randomised IP, ticagrelor or placebo, and for whom any post-dose data were available. Patients were analysed according to the actual treatment.|||Number of events|||Number
1313375|NCT02482298|Other Pre-specified|Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients)|To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD|Baseline through Week 12|The Safety analysis set included all patients who received at least 1 single dose of randomised IP, ticagrelor or placebo, and for whom any post-dose data were available. Patients were analysed according to the actual treatment.|||Number of patients|||Number
1313376|NCT02482298|Secondary|Change in Proportion of Days With Analgesic Use Measured by an eDiary|To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease.|Baseline through Week 12|The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.|||Proportion of days with analgesic use||90% Confidence Interval|Least Squares Mean
1313377|NCT02482298|Secondary|Average of the Daily Worst Pain Values Reported Via eDiary|To determine the efficacy of 2 different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. Intensity of pain was recorded on an 11-point scale where 0 represented no pain and 10 represented the worst pain imaginable.|Baseline through Week 12|The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.|||Average daily worst pain rating||Standard Deviation|Mean
1317268|NCT02368314|Secondary|Frequency of Clinically Significant “Small” Bleedings||During the treatment period (14 days)|||||||
1313378|NCT02482298|Primary|Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary|To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.|Baseline through Week 12|The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.|||Proportion of days with pain||90% Confidence Interval|Least Squares Mean
1313379|NCT02482129|Secondary|Number of Subjects With Anti-LME636 Antibodies Present at Each Visit|Serum samples were collected and assessed for anti-LME636 antibodies. Samples collected from subjects in the LME636 dose group were analyzed for anti-LME636 antibodies. For subjects in the dexamethasone group, only the samples collected on Day 1 (ie, prior to the start of treatment) were analyzed for anti-LME636 antibodies.|Day 1, Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects with available immunogenicity data and no protocol deviations with relevant impact on the data (Immunogenicity Set).|||Participants|||Count of Participants
1313380|NCT02482129|Secondary|Mean Serum Concentration of Total LME636 at Each Visit|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. Concentrations below the limit of quantification (BLQ), defined as 0.25 ng/mL, were reported as NA with no imputation for missing data.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects who received investigative product (IP) and had at least 1 evaluable serum sample following IP exposure.(Pharmacokinetics Analysis Set). Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
1313381|NCT02482129|Secondary|Use of Rescue Treatment|Use of rescue treatment is presented as the number of subjects with first use of rescue treatment by visit. Subjects receiving rescue medication were not considered withdrawn and the collection of data continued after discontinuation of study treatment. Only one eye contributed to the analysis.|Day 4, Day 8, Day 15|Per Protocol Analysis Set|||Participants|||Count of Participants
1313382|NCT02482129|Secondary|Time-to-Response|Time-to-Response was defined as the number of days from baseline to the first scheduled visit when a two-step decrease or more from baseline in AC Cell Grade (as per SUN) was observed. Time-to-Response is reported as number of subjects presenting time-to-response by visit. Only one eye contributed to the analysis.|Baseline (Day 1), Up to Day 15|Per Protocol Analysis Set|||Participants|||Count of Participants
1313383|NCT02482129|Secondary|Mean Change From Baseline in BCVA at Each Visit|Visual Acuity (VA) was measured with the participant's best spectacles or other visual corrective device in place using an ETDRS or Snellen visual acuity chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.|||letters||Standard Deviation|Mean
1313384|NCT02482129|Secondary|Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment|IOP was assessed using Goldmann applanation tonometry or Tonopen and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Day 1), Up to Day 29|Safety Analysis Set|||Participants|||Count of Participants
1313385|NCT02482129|Primary|Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit|The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set|||participants|||Number
1313386|NCT02482129|Primary|Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit|Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set|||participants|||Number
1313387|NCT02482129|Primary|Mean Intraocular Pressure (IOP) at Each Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.|||mmHg||Standard Deviation|Mean
1313388|NCT02482129|Primary|Mean Best Corrected Visual Acuity (BCVA) at Each Visit|Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects who received any study drug (Safety Analysis Set). Number Analyzed is the number of subjects with data at visit.|||letters||Standard Deviation|Mean
1313389|NCT02482129|Primary|Number of Responders at Day 15|Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.|Baseline (Day 1), Day 15|This analysis population includes all subjects who received any study drug, had at least 1 post-baseline efficacy assessment, had no critical protocol deviations, and had a valid determination of response status for the primary endpoint (Per Protocol Analysis Set).|||Participants|||Count of Participants
1313390|NCT02481934|Secondary|Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization|Efficacy will be assessed monthly during NKAE treatment (4 months) by peripheral blood monoclonal protein monitoring. During follow-up, efficacy will be evaluated monthly the first 6 months. After that, quarterly until one year of follow-up.|16 months||||participants|||Number
1313677|NCT02473523|Other Pre-specified|Median Change in PedsQL Cancer Module Score|Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313391|NCT02481934|Primary|Number of Participants With Adverse Events During NKAE Treatment|Toxicity will be assessed by adverse events count during NKAE treatment monitoring peripheral blood absolute neutrophil count (cells/μl). Toxicity will be evaluated monthly during NKAE treatment (4 months). During follow-up, it will be assessed monthly the first 6 months. After that, quarterly until one year of follow-up, based on Common Toxicity Criteria for Adverse Events of the National Cancer Institute (CTCAE) to v.4.03.|16 months|Analysis per protocol|||participants|||Number
1313392|NCT02481219|Secondary|Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable CRF|Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.|Full analysis set|||percentage of participants with >1 AE|||Number
1313393|NCT02481219|Secondary|Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable case report form (CRF)|an expected average of 3 weeks from study procedure|PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake <1h and > 2.15h, Morning PEG intake <1h and >2:15 h, Capsule ingestion l<45 min or >75 min after PEG intake , Overall PEG intake volume is less than 3 liters|||percentage of participants|||Number
1313394|NCT02481219|Secondary|Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|Per protocol analysis set|||percentage of participants|||Number
1313395|NCT02481219|Secondary|Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE|Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.|||hours||Full Range|Median
1313396|NCT02481219|Secondary|Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.|||percentage of participants|||Number
1313397|NCT02481219|Primary|Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)|The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).|Within two weeks of study procedure|this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.|||percentage of particpants|||Number
1313398|NCT02481141|Secondary|Change From Baseline in Triglycerides (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
1313399|NCT02481141|Secondary|Change From Baseline in HDL (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
1313400|NCT02481141|Secondary|Change From Baseline LDL (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
1313401|NCT02481141|Secondary|Change From Baseline in Total Cholesterol (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
1313402|NCT02481141|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c %|Baseline, Week 2, Week 4, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||percentage of HbA1c||Standard Error|Mean
1313403|NCT02481141|Secondary|Change From Baseline in Body Weight|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||kg||Standard Error|Mean
1313404|NCT02481141|Secondary|Change From Baseline in 2 Hour Post Meal Glucose Level|Change from baseline in blood glucose levels 2 hours after breakfast|Baseline, Week 2, Week 4, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
1313405|NCT02481141|Primary|Change From Baseline in Fasting Blood Glucose|The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA – SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.|Baseline, Week 2, Week 4, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
1313406|NCT02481141|Primary|Subjects With Adverse Events as a Measure of Safety and Tolerability|The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA – SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.|Week 2, Week 4, Week 12|Safety population included all subjects who took at least one dose of study product.|||Participants|||Count of Participants
1313407|NCT02480712|Secondary|Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12||Week 12; Posttreatment Week 12|"Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:~Boosted TDF-containing regimens~Non-boosted TDF-containing regimens~Non TDF-containing regimens"|||mg/dL||Standard Deviation|Mean
1313408|NCT02480712|Secondary|Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment||Up to 12 Weeks|"Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:~Boosted TDF-containing regimens~Non-boosted TDF-containing regimens~Non TDF-containing regimens"|||percentage of participants|||Number
1313409|NCT02480712|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1313410|NCT02480712|Secondary|HCV RNA Change From Baseline/Day 1||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1313411|NCT02480712|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 Weeks|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1313412|NCT02480712|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1313413|NCT02480712|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1313414|NCT02480712|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: All enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1313415|NCT02480621|Primary|Pain Levels on a Visual Analog Scale ( VAS)|A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.|Immediate post-operative period until 72 hours post-operatively||||units on a scale||Standard Deviation|Mean
1313416|NCT02480582|Secondary|24 Hour Energy Intake|Measured reductions in total within-day energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g, at every test meal, to determine energy intake. Total energy intake will then be calculated. 24 hour energy intake will be measured on three occasions, on average a week apart.|3 Weeks||||kcal||Standard Deviation|Mean
1313417|NCT02480582|Secondary|Appetite Sensations (Hunger)|"Measured differences in hunger following consumption of almonds as a mid-morning snack compared to control and comparator.~Appetite sensations will be measured during the three intervention conditions at regular time intervals from the morning to the evening (21 in total) using 100-mm visual analogue scale (VAS).~Scale range = 0-100 mm, with higher values indicating greater hunger. Total Area Under the Curve will be calculated from the VAS profiles using the trapeziodal method.~Time points at which data were collected to calculate AUC - -5, 15, 30, 60, 90, 120, 135, 180, 230, 240, 270, 280, 300, 360, 420, 480, 510, 540, 600; -5 to 8 hours post intervention.~Higher AUC scores on hunger are interpreted as a worse outcome."|3 Weeks||||minutues*mm||Standard Deviation|Mean
1313418|NCT02480582|Secondary|Food Preference|"Measured changes in wanting for high fat food food following consumption of almonds as a mid-morning snack compared to control and comparator.~Food preference will be measured once during each intervention condition using the Leeds Food Preference Questionnaire (LFPQ: Finlayson, King & Blundell, 2008).~8 high fat foods and 8 low fat foods are presented on a computer and participants rate the extent to which they want each food (How much do you want this food now?). The food images are presented individually, in a randomised order and participants make their ratings using a 100-mm VAS. Low fat scores are subtracted from high fat scores to provide a relative preference score.~Scale range: -100 to 100. Higher scores indicate greater wanting for high fat foods which is interpreted as a worse outcome."|3 Weeks||||units on a scale||Standard Deviation|Mean
1313419|NCT02480582|Primary|Test Meal Energy Intake|Measured reductions in ad-libitum energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g to determine energy intake. Test meal energy intake will be measured on three occasions, on average a week apart.|3 Weeks||||kcal||Standard Deviation|Mean
1313420|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute [bpm]).|First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1313422|NCT02480439|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1313423|NCT02480439|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1313424|NCT02480439|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1313425|NCT02480439|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.|||mg/mL||Standard Deviation|Mean
1313426|NCT02480166|Secondary|Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.|Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)|Day 1 of treatment to 12 weeks post treatment||||Participants|||Count of Participants
1313427|NCT02480166|Primary|Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment||12 weeks after end of therapy||||Participants|||Count of Participants
1313428|NCT02480153|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 in the Intent-to-Treat (ITT) Population|ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: participant's assessment of arthritis pain; participant's global assessment of arthritis; physician's global assessment of arthritis; high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Week 0, week 2, week 4, week 6, week 8 and week 12|The Intent-to-Treat (ITT) population was defined as all participants who were randomized to study treatment. Non-responder imputation was applied.|||percentage of participants|||Number
1313429|NCT02480010|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
1313430|NCT02480010|Secondary|Volume of Distribution at Steady State of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||mL||Geometric Coefficient of Variation|Geometric Mean
1313431|NCT02480010|Secondary|Serum Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
1313432|NCT02480010|Secondary|Terminal Elimination Half-Life (t1/2) of Pertuzumab|t1/2 is the time in days required for the concentration of the drug to reach half of its original value|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
1313433|NCT02480010|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Cmax refers to the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. tmax is the time at which the Cmax is observed.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1 and on Days 8 and 15, Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population|||days||Geometric Coefficient of Variation|Geometric Mean
1313434|NCT02480010|Secondary|Maximum Plasma Concentration of Pertuzumab|Cmax is the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. Cmax is measured as micrograms per mL (μg/mL).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1313499|NCT02478164|Secondary|Best Radiographic Response|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.|Disease was assessed radiographically for response every 8 weeks, assessed up to 24 weeks.||||Participants|||Count of Participants
1313435|NCT02480010|Secondary|AUC to Last Measurable Concentration (AUC0-last) of Pertuzumab|The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population|||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
1313436|NCT02480010|Secondary|Area Under the Concentration Curve Extrapolated to Infinity (AUC0-Inf) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (µg*day/mL)|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
1313437|NCT02480010|Secondary|Change From Baseline in N-Telopeptide|In bone physiology, the N-terminal telopeptide (or more formally, amino-terminal collagen crosslinks, and known by the acronym NTX) is a telopeptide that can be used as a biomarker to measure the rate of bone turnover. NTX can be measured in the urine (uNTX) or serum (serum NTX).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.||||||
1313438|NCT02480010|Secondary|Change From Baseline in Bone Alkaline Phosphatase|Bone alkaline phosphatase (BAP) is the bone-specific isoform of alkaline phosphatase. Serum Bone alkaline phosphatase is used to measure osteoporosis and is measured as units per liter (u/L).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.||||||
1313439|NCT02480010|Secondary|Time to Treatment Failure|Time to Treatment Failure was time to the first documentation of progressive disease, day of death while on study (or 30 days after withdrawing from the trial) or day of early discontinuation due to toxicity (adverse events or abnormal laboratory value), refusal of treatment/refusing to cooperate/withdrawing consent, insufficient therapeutic response, or failure to return, whichever is earliest, after the start of treatment. Participants who did not experience any of the above events while on study were censored on the day of their last PSA or tumor measurement, whichever was later.|Every 3 weeks up to a maximum of 18 weeks|ITT Population|||days||Full Range|Median
1313440|NCT02480010|Secondary|Overall Survival|Overall survival was defined as the interval of time in weeks between start of treatment and day of death. Participants who did not die while being followed were censored at the last time that they were known to be alive.|Screening, Every 3 weeks up to a maximum of 18 months|Data were not analyzed due to early termination of the study.||||||
1313441|NCT02480010|Secondary|Time to Prostate Cancer Pain Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events: 1) Opioid therapy, 2) Radiation therapy, 3) Glucocorticoid therapy, 4) Radionuclide therapy or 5) Chemotherapy.|Every 3 weeks up to a maximum of 18 weeks|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
1313442|NCT02480010|Secondary|Percentage of Participants Without Progression|Disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Non-progression included participants who had responded plus those who had not responded and not progressed within the first 3 cycles.|Screening, Weeks 3, 6, 9 and 12|ITT population|||percentage of participants|||Number
1313443|NCT02480010|Secondary|Duration of Response According to RECIST Criteria|For participants with measurable disease, duration of response was defined as first documentation of tumor response, either a PR or CR, to first documentation of PD or death. Participants who never progressed or died were censored at their last tumor measurement.|Baseline, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
1313444|NCT02480010|Secondary|Duration of Response According to PSA Levels|Duration of PSA Response was measured from first 50% decline in PSA compared to baseline until the time at which there was an increase of ≥50% from the PSA nadir, provided the absolute increase was at least 5 nanograms per milliliter (ng/ml). The increase must have been confirmed by a second consecutive measurement that was at least 50% above the nadir.|Baseline, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
1313445|NCT02480010|Secondary|Time to Response|Time to response was the date of the first documentation of PSA response.|Screening, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
1313446|NCT02480010|Secondary|Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall objective response by RECIST criteria (CR or PR) was to be defined for participants who had measurable disease at baseline or developed new lesions post-baseline. The longest diameter only for all target lesions was measured and the following responses recorded: CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter as compared to the baseline sum longest diameter.|Screening, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
1313678|NCT02473523|Other Pre-specified|Mean Change in PedsQL Cancer Module Score|Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313447|NCT02480010|Secondary|Time to Disease Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events. 1) PSA progression as defined by the PSAWG, 2) Evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 3) One bone scan at least 6 months subsequent to baseline demonstrating 2 or more new skeletal lesions and 4) An event due to metastatic prostate cancer requiring intervention.|Screening, Every 3 weeks up to a maximum of 18 months|ITT population|||weeks||Full Range|Median
1313448|NCT02480010|Primary|Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab|Objective PSA response rate was determined according to Prostate Specific Antigen Working Group (PSAWG) guidelines. All participants achieving a drop in PSA of greater than or equal to (≥) 50 percent (%) from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria of a PSA response. The confirmatory second value had to be at least 50% lower than baseline, but could be higher than the first drop in PSA. Confirmatory value could not be 50% higher compared to first drop in PSA. The date of response was the date the first 50% (or greater) decline was observed. Progressive disease (PD) was defined by a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which documented progressively increasing values. Non-response was defined as neither PD nor Response.|Screening, Every 3 weeks up to Week 24|ITT population|||percentage of participants|||Number
1313449|NCT02479763|Primary|Percentage of Patients With Successful Epidural Blocks|Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.|up to 15 minutes after the procedure||||percentage of patients|||Number
1313450|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmin of AZD7594|Comparison of steady-state minimum (pre-dose) concentration (Cmin) of AZD7594 in each treatment period|On Day 14 at pre-dose in each period|The subset of all randomized participants, 24-hour PK sampling was performed on Day 14, primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data. Cmin was not determined for AZD7594 58 μg|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313451|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24)/D of AZD7594|Comparison of AUC(0-24)/D (dose-normalized AUC(0-24)) of AZD7594|On Day 14 in each period|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L/ μmol||Geometric Coefficient of Variation|Geometric Mean
1313452|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax/D of AZD7594|Comparison of Cmax/D (dose-normalized Cmax) of AZD7594|On Day 1 in each period|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L/μmol||Geometric Coefficient of Variation|Geometric Mean
1313453|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cavg,ss of AZD7594|Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313454|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Tmax,ss of AZD7594|Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||Hour||Full Range|Median
1313455|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Tmax of AZD7594|Comparison of tmax (time to reach maximum plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||Hour||Full Range|Median
1313620|NCT02475031|Secondary|Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours|All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point.|up to 60 hours||||mg||Standard Error|Mean
1313456|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-last) of AZD7594|Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (Day 1 and Day 14)) of AZD7594 (i.e. in participants with intensive pharmacokinetic assessments)|On Day 1 and Day 14 in each period (in participants with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313457|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24) of AZD7594|Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313458|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax,ss of AZD7594|Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313459|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of AUC(0-4) of AZD7594|Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|The subset of all randomized participants; 24-hour PK sampling was performed on Day 14, the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313460|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Cmax of AZD7594|Comparison of Cmax (maximum observed plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|The PK analysis set (PKS) included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1313461|NCT02479412|Secondary|Number of Participants With Adverse Events|Assessment of safety and tolerability of three dose levels of AZD7594 in participants with mild to moderate asthma. IP referred to investigational product.|From Screening to Follow-up (these two examinations are up to 165 days apart)|The safety analysis set (SAF) included all randomized participants who received at least one dose of randomized study drug during the treatment periods of the study. This analysis set was classified by actual treatment received. If no participants received incorrect treatment then the SAF was identical to the FAS.|||Number of participants|||Number
1313462|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Asthma Control Days|The efficacy of AZD7594 was assessed in terms of amount of asthma control days in each treatment period. An asthma control day was defined as a day with asthma symptom score = 0, a night with no awakenings due to asthma symptoms and a day with no use of rescue medication. A given calendar day was defined as an asthma control day if it fulfills the criteria for a symptom-free day and for a rescue medication-free day|At baseline and from Day 1 to Day 14 post-dose in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Asthma control days||95% Confidence Interval|Least Squares Mean
1313463|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Daily Symptom Score|The efficacy of AZD7594 was assessed in terms of change in daily symptom score from baseline to average of treatment period post dose (Day 1-14) in each treatment period. Severity scores for asthma symptoms were recorded twice daily, once in the morning and once in the evening with the scoring system of 0-no asthma symptoms, 1-toleratable asthma symptoms, 2-discomfort asthma symptoms with normal activities (or with sleep) and 3-asthma symptoms with impaired normal activities (or to sleep).|At baseline and from Day 1 to Day 14 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
1317269|NCT02368314|Secondary|Frequency of “Big” Bleedings||During the treatment period (14 days)|||||||
1313464|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Night-time Awakenings|"The efficacy of AZD7594 was assessed in terms of change in nighttime awakenings in each treatment period. The patients were asked to answer ‘Yes’ or ‘No’ to the question of Did your asthma cause you to wake up last night?”. If yes, the number and percentage of days that had a night-time awakening were determined for each of the study periods."|At baseline and from Day 2 to Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Number of nighttime awakenings||95% Confidence Interval|Least Squares Mean
1313465|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 8 in Asthma Control Questionnaire-5|The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a lower score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.|At baseline and on Day 8 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
1313466|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 15 in Asthma Control Questionnaire-5|The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a higher score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.|At baseline and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
1313467|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Average Daily Use of Rescue Salbutamol Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in average daily use of salbutamol (each morning and evening) in each treatment period.|Every day from Day 1 to Day 15 (from evening of Day 1 to morning of Day 15)|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Number of inhalations per day||95% Confidence Interval|Least Squares Mean
1313468|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Evening Peak Expiratory Flow (ePEF) Before Administration Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in evening peak expiratory flow (ePEF) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as ePEF together with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).|Every evening from Day 1 to Day 14 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||L/min||95% Confidence Interval|Least Squares Mean
1313469|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Peak Expiratory Flow (mPEF) Before Administration Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in morning peak expiratory flow (mPEF) before administration of the investigational medicinal product (IMP) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as mPEF with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).|Every morning at pre-dose from Day 1 to Day 15|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||L/min||95% Confidence Interval|Least Squares Mean
1313470|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)|On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
1313471|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 15|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14)|On Day 1 (pre-dose) and on Day 15 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
1313496|NCT02478372|Primary|Proportion of Patients Discharged From Rehabilitation by Day Four|"% of patients meeting predetermined discharge criteria at 96 Hours post-surgery.~The discharge criteria were: self dependent (dress, personal care); in and out of bedd independently; up and down stairs; walk with crutches/stick; 80 degrees knee flexion; able to straight leg raise operated limb."|96 hours|Patients included following randomisation|||percentage of patients|||Number
1313621|NCT02475031|Primary|Total Narcotic Usage at 48 Hours|The primary endpoint of this study will be narcotic requirement at 48 hours|48 hours||||mg||Standard Error|Mean
1313472|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)|On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
1313473|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 15|The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 15|On Day 1 (pre-dose) and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Parts per billion (ppb)||95% Confidence Interval|Least Squares Mean
1313474|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 8|On Day 1 (pre-dose) and on Day 8 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Parts per billion (ppb)||95% Confidence Interval|Least Squares Mean
1313475|NCT02479412|Primary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15|Comparison of the efficacy of AZD7594 in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14) with placebo|On Day 1 (pre-dose) and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the full analysis set (FAS), following the principle of intent to treat (ITT). Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
1313476|NCT02479139|Secondary|Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%|"GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.~The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported."|Baseline, Weeks 4, 8, 12 and 18|mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.|||percentage of participants|||Number
1313477|NCT02479139|Secondary|Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points|"The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.~The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported."|Baseline, Weeks 4, 8, 12 and 18|mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.|||percentage of participants|||Number
1313478|NCT02479139|Primary|Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%|"The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.~GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.~The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported."|Baseline, Week 12|Modified Intent-to-Treat (mITT) population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the last observation carried forward (LOCF) approach.|||percentage of participants|||Number
1313479|NCT02478671|Secondary|Hand Perfusion as Measured by Pulse Oxymetry Waveform|pulse oxymetry waveform will be used to measure arterial perfusion|Subjects will be followed up to one week post procedure||||percent saturated||Full Range|Mean
1313480|NCT02478671|Primary|MRI Based Radial Artery Measurement|Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.|Subjects will be followed up to one week post procedure||||millimeters||Full Range|Mean
1313481|NCT02478632|Secondary|Change From Baseline in Lumbar Spine and Total Hip BMD T-scores and Z-scores by Baseline Third Agent|Change from Baseline in lumbar spine and total hip BMD was assessed by T-scores and Z-scores at Baseline and Week 48. Change from Baseline (Day 1) was calculated as the value at Week 48 minus Baseline. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old of the same sex. Caucasian reference values were used for all subjects to calculate T-scores. T-score values > -1.0 are considered normal, T-score values < -1.0 to > -2.5 indicate osteopenia and T-score values <= -2.5 indicate osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study Caucasian reference values were used in calculation of Z-scores. Most BMD values, statistically, would fall within + or – 3 standard deviations of what is considered normal.|Baseline and Week 48|ITT-ED Population|||Score on a scale||95% Confidence Interval|Mean
1313482|NCT02478632|Secondary|Percent Change From Baseline in Lumbar Spine and Total Hip BMD by Baseline Third Agent|Percent change from Baseline (Day 1) to Week 48 in total hip and lumbar spine BMD (expressed as areal density in g/cm2) assessed by third agent class at Baseline. Percent change from Baseline was calculated as value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model adjusted for Baseline BMD values was used to compare the difference in percent change from Baseline to Week 48 in total hip BMD or in lumbar spine BMD between the DTG+RPV and CAR arms by third agent class: integrase inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mean and 95 percent CI were estimated. For BMD expressed as areal density (g/ cm2 ), most BMD values, statistically, would fall within + or – 3 standard deviations of what is considered normal. Only those participants with evaluable DEXA scans at Baseline and Week 48 were included.|Baseline and Week 48|ITT-ED Population|||g/cm^2||95% Confidence Interval|Mean
1313483|NCT02478632|Secondary|Change From Baseline in Lumbar Spine and Total Hip BMD Assessed by T-score and Z-score|Change from Baseline in lumbar spine and total hip BMD was assessed by T-scores and Z-scores at Baseline and Week 48. Change from Baseline (Day 1) was calculated as the value at Week 48 minus Baseline. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old of the same sex. Caucasian reference values were used for all subjects to calculate T-scores. T-score values > -1.0 are considered normal, T-score values < -1.0 to > -2.5 indicate osteopenia and T-score values <= -2.5 indicate osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study Caucasian reference values were used in calculation of Z-scores. Most BMD values, statistically, would fall within + or – 3 standard deviations of what is considered normal.|Baseline and up to Week 48|ITT-ED Population|||Score on a scale||95% Confidence Interval|Mean
1313484|NCT02478632|Secondary|Percent Change From Baseline in Lumbar Spine BMD|Percent change in BMD as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statitical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. The Baseline was considered as Visit 1 value and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model adjusted for the Baseline BMD value, age at study entry and Baseline BMI was used to compare the difference in percentage change from Baseline at week 48 in lumbar spine BMD between the DTG+RPV and CAR arms. Mean and 95 percent CI were estimated.|Baseline and Week 48|ITT-ED Population|||g/cm^2||95% Confidence Interval|Mean
1313485|NCT02478632|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)|Percent change in BMD (expressed as areal density in g/cm2) as specified by dual energy X-ray absorptiometry (DEXA) scans of the left ‘total hip’ which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. The Baseline was considered as Visit 1 and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An analysis of covariance (ANCOVA) model was used to compare the difference. The analysis was performed on Intent-to-Treat exposed DEXA (ITT-ED) Population which comprised of all participants in the ITT-E Population who received at least one dose of study treatment, and who were registered for the 202094 study.|Baseline and Week 48|ITT-ED Population|||gram per centimeter square (g/cm^2)||95% Confidence Interval|Mean
1313486|NCT02478580|Secondary|The Aldrete Score|Aldrete score used for readiness of PACU discharge by assigning numeric values to the criteria including activity, respiration, circulation, consciousness, and color. Each criterion is rated from 0 to 2, with a maximum score of 10. Scores in the range of 9 to 10 are considered satisfactory for PACU discharge.|2 hours after extubation||||units on a scale||Standard Error|Mean
1313487|NCT02478580|Primary|Postoperative Care Unit (PACU) Recovery Time|Participants will be followed for the duration of PACU stay, an expected average of 3 hours.|Immediate postoperative period (up to 3 hours)|Patient with obstructive sleep apnea undergoing surgery|||Minutes||Standard Deviation|Mean
1313488|NCT02478372|Secondary|Total Number of Reported Participants With Complications and/or Adverse Events|The composite number of adverse events reported per group at 30 days and then one year post surgery|30 days and one year post-surgery||||participants|||Number
1313489|NCT02478372|Secondary|Patient Reported Outcome Measure - Oxford Knee Score|Units measured on old Oxford Score (12-60) from a 12 point questionnaire. Where in 60 is poor and lower scores are better patient reported outcome scores|one week prior to surgery, 6 weeks post-surgery , one year post-surgery||||units on a scale||Full Range|Median
1313490|NCT02478372|Secondary|Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation||On day of discharge from rehabilitation in-patient care (average 96 hours post surgery)||||angle of flexion (degree)||Inter-Quartile Range|Median
1313491|NCT02478372|Secondary|Day of Ambulation|Proportion of patients per day to ambulate for the first time with the physiotherapist > 3 Metres|theatre day, day 1 post-surgery, day two post-surgery||||percentage of patients|||Number
1313492|NCT02478372|Secondary|Post-operative Nausea and Vomiting Scores|percentage of patients reporting either symptoms of nausea or vomiting over the first 72 hours following surgery. Scale 0-2 wherein 0=no nausea and vomiting, 1=nausea and 2= nausea and vomiting|24hours, 48 hours and 72 hours post-surgery||||percentage of patients reporting PONV|||Number
1313493|NCT02478372|Secondary|Post-operative Urinary Catheterisation Rates|% of patients requiring catheterisation for urinary retention post-surgery|72 hours post-surgery||||percentage of patients catheterised|||Number
1313494|NCT02478372|Secondary|Verbal Rating Score (VRS) Pain Scores|Summary 24 hour Verbal rated numerical pain scores were gathered each day. Scale range 0-10 where 0 is no pain and 10 is worst imaginable pain|24hours, 48 hours and 72 hours post-surgery||||units on a scale||Standard Deviation|Mean
1313495|NCT02478372|Secondary|Average Post-operative Length of Stay|Participants will be followed for the duration of hospital stay, an expected average of 5 days|Average number of days spent in hospital follwoing surgery, an expected average of 5 days||||days||Inter-Quartile Range|Median
1317270|NCT02368314|Secondary|Frequency of “Big” and Clinically Significant “Small” Bleedings||During the treatment period (14 days)|||||||
1313500|NCT02478164|Primary|3-Month Progression-Free Survival (PFS3)|PFS3 is the proportion of patients remaining alive and progression-free at 3-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria. RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non-enhancing lesions, and stable or improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR,PR or PD.|3 months||||Participants|||Count of Participants
1313501|NCT02477709|Primary|Effect of Gefapixant on BP|BP data will be summarized using descriptive statistics|6 hours||||units on a scale||Full Range|Mean
1313502|NCT02477605|Secondary|Mean Post-operative Pain Rating at Day 1|The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.|Day 1 post operative|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.|||units on a scale||Standard Deviation|Mean
1313503|NCT02477605|Secondary|Mean Conjunctival Edema Score at Week 1|Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.|Week 1 post operative|Intent-to-Treat Set. Number Analyzed is the number of subjects with data.|||units on a scale||Standard Deviation|Mean
1313504|NCT02477605|Primary|Mean Change in Intraocular Pressure (IOP) on Operative Day|IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.|Day 0 preoperative, Day 0 postoperative|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.|||mmHG||Standard Deviation|Mean
1313505|NCT02477527|Other Pre-specified|Safety as Measured by Side Effects|Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.|24 weeks|no adverse effects reported.|||Participants|||Count of Participants
1313506|NCT02477527|Secondary|Improvements in Sleep Disorder Score|Changes in quality of sleep at week 24 as measured by Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) is used to measure the quality and patterns of sleep in adults. It rates sleep based on seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. It is a self-administered questionnaire covering these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The scores for the 7 items ranged from 0(none) - 3(severe), and the total score is 0-21. The reported values in the table represent the change in the overall scores on the PSQI scale. The values were added and reported as the sum of the individual measures. A negative score correlates with improvement of the sleep quality.|24 weeks||||units on a scale||Full Range|Mean
1313507|NCT02477527|Secondary|Improvements in Central Nervous System Toxicity Score|"Changes in Central Nervous System toxicity score at week 24 as measured by SSAT 047 scale.~The scale is a questionnaire that participants complete at each visit. The SSAT 047 scores 10 items related to efavirenz side effects including: dizziness, depression, insomnia, anxiety, confusion, impaired concentration, headache, somnolence, aggressive mood and abnormal dreams. The side effects were scored as 0 for “None”, 1 for “Mild”, 2 for “Moderate” and 3 for “Severe”. The scores for the 10 items ranged from 0(none) - 3(severe), and the total score is 0-30. The scores are then averaged to determine the overall impact on central nervous system symptoms and reported as the sum of the measures."|24 weeks||||units on a scale||Full Range|Mean
1313508|NCT02477527|Secondary|T-cell Changes|Change in CD4 Cell count from baseline to 24 weeks.|24 weeks|Participants completing the study.|||cells / cc||Full Range|Mean
1313509|NCT02477527|Primary|Percentage of Patients With Viral Loads < 50 Following the Switch|percentage of patients with viral loads < 50 following the switch at 24 weeks.|24 weeks|Participants completing the study.|||Participants|||Count of Participants
1313510|NCT02477020|Secondary|Change From Baseline in the University of California San Diego Performance-based Skills Assessment – Brief Version (UPSA-B) at Week 3 and 6|The UPSA-B evaluates the abilities of individuals to perform everyday tasks that are considered necessary for independent functioning in the community. The UPSA-B uses role playing situations to evaluate skills in 5 areas: household chores, communication, finance, transportation, and planning recreational activities. Subscale scores range from 0 to 20 points, and total scores range from 0 to 100 points; higher scores reflect better performance. Least square mean and standard error values were determined using a MMRM. A positive change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313511|NCT02477020|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at Weeks 3 and 6|The PSP scale is a clinician-reported outcome instrument that was developed to evaluate social and personal functioning. It measures 4 domains of social functioning: socially useful activities including work and study, personal and social relationships, self-care and disturbing and aggressive behaviors. The clinician assigns an initial 6-degree of severity to each area (absent, mild, manifest, marked, severe or very severe). The final result is a single assessment of social functioning ranging from 0 (no autonomy) to 100 (excellent functioning). Least square mean and standard error values were determined using a MMRM. A positive change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313512|NCT02477020|Secondary|Change From Baseline in Brief Negative Symptom Scale (BNSS) Score at Weeks 3 and 6|The BNSS is a13-item instrument designed for use in clinical trials and other studies that measures 5 domains of negative symptoms: blunted affect, alogia, asociality, anhedonia, and avolition. All the items in the BNSS are rated on a 7-point (0–6) scale, with anchor points generally ranging from the symptom’s being absent (0) to severe (6). A scale total score is calculated by summing the 13 individual items; total score range of 0 to 78, where higher score indicates higher severity of negative symptoms. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313513|NCT02477020|Secondary|Change From Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Score at Weeks 3 and 6|BACS is specifically designed to measure treatment- related improvements in cognition and includes alternate forms. The battery of tests in the BACS includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory, and motor speed. The primary measure from each test of the BACS is standardized by creating z-scores whereby the mean of the test session of a healthy participant is set to 0 and the standard deviation set to 1. A composite score was calculated by averaging all of the 6 standardized primary measures from the BACS, and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participant’s cognition is compared to a healthy person. Least square mean and standard error values were determined using a MMRM.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||z-score||Standard Error|Least Squares Mean
1313514|NCT02477020|Secondary|Percentage of Responders Based on CGI-I Ratings Score|Responder based on CGI-I is defined as a rating of much improved or very much improved. The CGI-I assesses the participant’s improvement (or worsening). The clinician is required to assess the participant’s condition relative to baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||percentage of participants|||Number
1313515|NCT02477020|Secondary|Clinical Global Impression Scale – Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 5 and 6|The CGI-I assesses the participant’s improvement (or worsening). The clinician is required to assess the participant’s condition relative to baseline on a 7-point scale. CGI-I scale assesses the participant's improvement (or worsening) on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Least square mean and standard error values were calculated using a MMRM.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313516|NCT02477020|Secondary|Change From Baseline in Clinical Global Impression – Severity (CGI-S) Score at Weeks 1, 2, 3, 4, 5,and 6|The CGI-S is a clinician rated scale designed to assess global severity of illness. CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. A participant is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313517|NCT02477020|Secondary|Percentage of Clinical Responders Based on the PANSS Total Score|Clinical responders based on the PANSS total score is defined as at least 30% improvement from baseline in the total score. PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||percentage of participants|||Number
1313518|NCT02477020|Secondary|Change From Baseline in PANSS Subscales at Weeks 1, 2, 3, 4, 5 and 6|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Positive subscale consists of 7 items which assesses the positive symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. General psychopathology subscale consists of 16 items which assesses the general symptoms of schizophrenia with subscale score ranging from 16 to 96, where higher score indicates greater severity. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313519|NCT02477020|Secondary|Change From Baseline in PANSS Subscales Using the Marder 5-factor Model at Weeks 1, 2, 3, 4, 5, and 6|PANSS subscales using the Marder 5-factor model include positive symptoms (8-items, total score = total score = 8 to 56, with a higher score indicating greater severity of symptoms), negative symptoms (7-items, total score = 7 to 49, with a higher score indicating greater severity of symptoms), disorganized thoughts (7-items, total score = 7 to 49, with a higher score indicating greater severity of symptoms), impulsivity/hostility (4-items, total score = 4 to 28, with a higher score indicating greater severity of symptoms), anxiety/depression (4-items, total score = 4 to 28, with a higher score indicating greater severity of symptoms). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313520|NCT02477020|Secondary|Change From Baseline in PANSS Total Score at Weeks 1, 2, 3, 4 and 5|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4 and 5|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
1313521|NCT02477020|Primary|Change From Baseline in the Positive and Negative Symptom Scale (PANSS) Total Score at Week 6|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a mixed model for repeated measures (MMRM). A negative change from Baseline indicates improvement.|Baseline and Week 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here number of participants analyzed are participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
1313522|NCT02476994|Secondary|Clinical Laboratory Tests||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313523|NCT02476994|Secondary|Adverse Events and Serious Adverse Events||Up to 30 Days After Subject's Last Study Treatment|Due to early termination of the study, no formal analysis was conducted.||||||
1313524|NCT02476994|Secondary|Vital Signs||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313525|NCT02476994|Secondary|Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313526|NCT02476994|Secondary|Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313527|NCT02476994|Secondary|Phytosterol, Cholesterol, and Squalene Levels||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313528|NCT02476994|Secondary|Weight||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313529|NCT02476994|Secondary|Fatty Acid Profile||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313530|NCT02476994|Secondary|Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2||Baseline|Due to early termination of the study, no formal analysis was conducted.||||||
1313531|NCT02476994|Secondary|Parenteral Nutrition-Associated Cholestasis (PNAC)||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313532|NCT02476994|Primary|Essential Fatty Acid Deficiency (EFAD)|Holman Index Calculation|Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
1313533|NCT02476890|Secondary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event|A secondary endpoint of the trial was the percentage of participants receiving gefapixant 100 mg and placebo who discontinued from the study due to an AE. The percentage of participants who discontinued from the study due to an AE was assessed for days 1-4.|Up to Day 4|The analyzed population was all randomized participants who took at least 1 dose of study treatment and had assessment of discontinuation due to an AE.|||Percentage of participants|||Number
1313534|NCT02476890|Secondary|Percentage of Participants Who Experienced One or More Adverse Events During Study Treatment and Follow up|A secondary endpoint of the trial was the percentage of participants receiving gefapixant 100 mg and placebo who had at least 1 adverse event (AE) over 4 days of treatment (including washout periods) in addition to 14 days (+3 days) until a post-treatment follow-up visit. An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an AE. The percentage of participants in any treatment group with at least 1 AE was assessed.|Up to Day 18|The analyzed population was all randomized participants who took at least 1 dose of study treatment and had assessment of AE occurrence.|||Percentage of participants|||Number
1313553|NCT02476422|Secondary|Number of Patients Needing Rescue Medication|The number of patients needing rescue medication within the 8 hour treatment period was evaluated.|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.|||Participants|||Number
1317271|NCT02368314|Secondary|Frequency of Venous Thromboembolism (PATE and/or DTV)||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1313535|NCT02476890|Secondary|Change From Baseline in Cough Frequency After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)|An ambulatory cough recording device recorded all sounds chronic cough participants made during cough monitoring to measure the change from baseline in objective cough frequency on the treatment days. A negative change from Baseline was considered to indicate improvement in cough frequency|Baseline and for 24 hours after cough challenge on treatment days|The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of cough frequency.|||Counts/hr||95% Confidence Interval|Least Squares Mean
1313536|NCT02476890|Secondary|Change From Baseline in Urge to Cough VAS After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)|Chronic cough participants completed a VAS to record the severity of their urge to cough, prior to dosing on the treatment day in each treatment period, and one hour after the final cough challenge on the treatment days. Participants marked the 100mm VAS at the extremes as ‘No urge-to-cough’ (0) and ‘Worst urge-to-cough’ (100). Participants were instructed to draw a single vertical line on the scale to indicate how severe their urge to cough was during the previous 1 hour on the treatment days. A negative change from Baseline was considered to indicate improvement in urge to cough.|Baseline and one hour after final cough challenge on treatment days|The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of urge to cough.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1313537|NCT02476890|Secondary|Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)|Chronic cough participants completed a visual analogue scale (VAS) to record cough severity, prior to dosing on the treatment day in each treatment period, and one hour after the final cough challenge on the treatment days. This was a 100mm VAS of cough severity from ‘No Cough’ (0) up to ‘Worst Cough’ (100). Participants were instructed to draw a line on the scale to indicate how severe they felt their cough was during the previous 1 hour on the treatment days. A negative change from Baseline was considered to indicate improvement in cough severity.|Baseline and one hour after the final cough challenge on treatment days|The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of cough severity.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1313538|NCT02476890|Primary|Cough Reflex Sensitivity to Distilled Water in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of distilled water inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of distilled water for cough challenge were 20%, 40%, 60%, 80%, and 100%. The Measure Type is least-squares mean in natural log scale. The number of coughs generated in 1 minute of exposure was recorded. The challenge agent was prepared by dilution of distilled water with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to distilled water challenge.|||natural log (percent concentration [%])||95% Confidence Interval|Least Squares Mean
1313539|NCT02476890|Primary|Cough Reflex Sensitivity to ATP in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of ATP inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of ATP for cough challenge were 0.1 mM, 0.3 mM, 1 mM, 3 mM, 10 mM, 30 mM, 100 mM, and 300 mM. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of ATP with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to ATP challenge.|||natural log (mM)||95% Confidence Interval|Least Squares Mean
1313540|NCT02476890|Primary|Cough Reflex Sensitivity to Citric Acid in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of citric acid inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of citric acid for cough challenge were 1 millimoles (mM), 3 mM, 10 mM, 30 mM, 100 mM, 300 mM, 1 M, and 3 M. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of citric acid with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to citric acid challenge.|||natural log (mM)||95% Confidence Interval|Least Squares Mean
1313554|NCT02476422|Secondary|Duration of Analgesia|Duration of analgesia (time to first use of rescue medication) was evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. Censored observations were included in calculating this endpoint. Censored subjects include any subject who did not take rescue medication prior to the end of the assessment period of 480 minutes (8 hours).|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
1313541|NCT02476890|Primary|Cough Reflex Sensitivity to Capsaicin in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of capsaicin inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of capsaicin for cough challenge were 0.3 micromoles (µM), 1 µM, 3 µM, 10 µM, 30 µM, 100 µM, 300 µM, and 1000 µM. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of capsaicin with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to capsaicin challenge.|||natural log (µM)||95% Confidence Interval|Least Squares Mean
1313542|NCT02476617|Primary|Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12|The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.|Week 0 to Post-Treatment Week 12|All participants who achieved SVR12 and had both baseline and post-baseline value at Post-Treatment Week 12 were included in this analyses..|||Fold change||Standard Deviation|Mean
1313543|NCT02476565|Other Pre-specified|Visualization Score|"The visualization of each of the following structures provides one point, for a maximum score of 7.~Right true vocal cord.~Left true vocal cord.~Right false vocal cord.~Left false vocal cord.~Right posterior cartilage~Left posterior cartilage~Epiglottis"|Up to 10 minutes||||units on a scale||Standard Deviation|Mean
1313544|NCT02476565|Secondary|Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube|Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube|Up to 10 minutes|2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 5 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.|||percent of participants|||Number
1313545|NCT02476565|Secondary|Time to Placement of the Endotrotracheal Tube|Time to the appropriate placement of the endotracheal tube.|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||second||Standard Deviation|Mean
1313546|NCT02476565|Secondary|Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.|Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.|Up to 10 minutes|2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 3 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.|||percent of participants|||Number
1313547|NCT02476565|Secondary|Time to Placement of the Aintree Airway Intubation Catheter|This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||seconds||Standard Deviation|Mean
1313548|NCT02476565|Secondary|Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device|Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device|Up to 10 minutes|4 participants in the LMA-Supreme arm were not included in analysis because the study was aborted at the request of the attending or the times to established safety cutoff for airway establishment (10 minutes) was exceeded.|||percent of participants|||Number
1313549|NCT02476565|Secondary|Time to Placement of the Supra Glottic Device|This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||seconds||Standard Deviation|Mean
1313550|NCT02476565|Primary|Time to Successful Tracheal Intubation|This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||seconds||Standard Deviation|Mean
1313551|NCT02476422|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death|Treatment emergent adverse events are reported in the below data table.|time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)|Safety analyses were performed on the safety set, which included all randomized subjects who were exposed to study drug.|||Participants|||Number
1313552|NCT02476422|Secondary|Number of Patients With Different Responses Based on Patient’s Global Assessment of Response to Treatment (PGART)|PGART was measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement was taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period).|At 8 hour postdose prior to use of rescue medication|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.|||Participants|||Number
1313666|NCT02473523|Other Pre-specified|Mean Change in Verbal Numeric Pain Scale|Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313555|NCT02476422|Secondary|Peak Analgesic Effect|"Peak analgesic relief is represented through highest pain intensity difference (PID), highest VASPI reduction, and highest pain relief scores. Pain intensity was measured on a verbal rating scale (VRS) ranging from 0 to 3 (none to severe, with higher score for higher pain intensity). PID represents difference in this score at baseline and specific time points, larger change indicating larger reduction in pain, with highest PID representing the largest difference. Pain relief was recorded on a scale ranging from 0 to 4 (none to complete, with higher score for higher pain relief), with highest pain relief representing maximum relief obtained. Pain intensity was also measured through a 100 mm visual analogue scale (VASPI), ranging from no pain (0 mm) to worst possible pain (100 mm). A positive change in VASPI indicates reduction in pain, with highest VASPI reduction representing highest change."|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Deviation|Mean
1313556|NCT02476422|Secondary|Summed Total Pain Relief (TOTPAR) at Different Time Points|"After the administration of the single dose of the assigned study treatment, at the defined study time points, the clinical site staff captured pain relief information from each subject.~The subject was asked “What is the amount of pain relief as compared to the starting pain?” and the response was recorded as 0 = none, 1 = a little, 2 = some, 3 = a lot, or 4 = complete.~Total pain relief (TOTPAR) was the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours were calculated. The weights used for these values (evaluation time points) were 0.25 for the 15-, 30-, 45-, and 60-minute observations, 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Error|Least Squares Mean
1313557|NCT02476422|Secondary|Sum of Pain Intensity Difference (SPID)|"At baseline and at each defined study time point, the clinical site staff captured pain intensity information from each subject using the 4-point categorical VRS. The subject was asked~“What is your pain level at this time?” and the response was recorded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Pain intensity difference (PID) was the difference between the baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations were also be done at 1 (SPID1), 2 (SPID2), 4 (SPID4) and 6 (SPID6) hours post dose. The weights used for these values were 0.25 for the 15-, 30-, 45-, and 60-minute observations, and 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Error|Least Squares Mean
1313558|NCT02476422|Secondary|Time to Onset of First Perceptible Pain Relief (FPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the first stopwatch as soon as he/she first began to feel 'any' relief from pain. The time elapsed was recorded as the FPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
1313559|NCT02476422|Secondary|Time to Onset of Meaningful Pain Relief (MPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the second stopwatch as soon as he/she began to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
1313560|NCT02476422|Secondary|Time to Confirmed First Perceptible Pain Relief|Time to onset of first perceptible pain relief (FPR), provided the FPR was subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant started two stopwatches at dosing, and recorded FPR by stopping the first stopwatch when he/she first experienced 'any' pain relief. FPR is ‘confirmed’ only if the participant also stopped the second stopwatch indicating ‘meaningful pain relief’.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
1313561|NCT02476422|Secondary|Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their pain intensity using the 100 mm VASPI to indicate their current level of pain intensity on the 100 mm VASPI labeled “no pain” (0 mm) as the left anchor and~“worst possible pain” (100 mm) as the right anchor. A positive change shows reduction in pain.~AUC of VASPI reduction from baseline for each time point was calculated using the trapezoidal rule."|15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale*hours||Standard Error|Least Squares Mean
1313592|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Day 7|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2.|Day 7|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313562|NCT02476422|Secondary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||Units on a scale||Standard Error|Least Squares Mean
1313563|NCT02476422|Primary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|60 minutes postdose|The efficacy analyses were performed on the full analysis set (FAS) which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Error|Least Squares Mean
1313564|NCT02476175|Secondary|Number of Participants Without Variation in Heart Rate|Cardiovascular safety: mean difference in heart rate (with variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
1313565|NCT02476175|Secondary|Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries|"Effectiveness will also be assessed using the Patient Perception of Bladder Condition (PPBC) scale on a 6-point scale ranging from 1 to 6 ( 1 is the best score and 6 is the worst score), at study initiation, every visit and at the study end.~Results will be documented based on subjective relief of symptoms and objective voiding diaries.~Participants perception of bladder condition score at initiation of treatment was:4 and at last follow up score was: 2."|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
1313566|NCT02476175|Secondary|Number of Participants With Cardio Vascular Safety|Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg), blood pressure was taken at each visit and at the study end.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
1313567|NCT02476175|Primary|Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy|On voiding diary, participants described their urgency according to the Canadian Urological Association voiding diary, range 0 to 3 at study entry and at study end.|up to 52 weeks||||Participants|||Count of Participants
1313568|NCT02476175|Primary|Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron|Results were based on the International Children's Continence Sociéty classification. Parents or patients supervised by their parents rated symptom relief on a questionnaire as complete cure (definied as dryness) or partial response (reduction of 50% to 99% in incontinence episodes).|up to 52 weeks||||Participants|||Count of Participants
1313569|NCT02476032|Secondary|Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups|"An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.~Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain~0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain"|30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline||||units on a scale||Standard Error|Mean
1313570|NCT02476032|Primary|Schiff Air Test: Mean Reduction in Sensitivity Between Groups|"An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.~Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity~0 Tooth/Patient did not respond to the air stimulus~Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus~Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus~Tooth/Patient responded to the air stimulus, considered the stimulus painful, and requested discontinuation of the stimulus"|30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline||||units on a scale||Standard Error|Mean
1313571|NCT02475980|Secondary|Follow-up Adherence|Proportion of girls who present for follow-up appointment after referral to Adolescent Gynecology outpatient clinic|4 weeks after enrollment|Number of participants given a referral to Adolescent Gynecology in PED|||participants|||Number
1313572|NCT02475980|Secondary|Descriptive Statistics of Participants|Frequencies and descriptive statistics of participant demographics, comorbidities associated with unintended adolescent pregnancy, and contraceptive use|At conclusion of study data collection, approximately 8 weeks after enrollment|Participants consented for project|||participants|||Number
1313573|NCT02475980|Primary|Contraceptive Initiation|Proportion of participants who report initiating contraception or changing to a more effective method of contraception|4 weeks after enrollment|Of the 13 girls consented to the study, 1 initiated a new contraception method following the intervention.|||participants|||Number
1313574|NCT02475980|Primary|Participant Satisfaction|Participant ratings of acceptability of contraceptive counseling in the emergency department and satisfaction with counseling|4 weeks after enrollment|Number of girls available for follow-up at 4-week phone call.|||participants|||Number
1313575|NCT02475980|Primary|Proportion of Eligible Girls Offered Counseling Intervention|Proportion of girls eligible to participate in study who were offered contraceptive counseling|Approximately 4 weeks after enrollment||||participants|||Number
1313576|NCT02475980|Primary|Length of Stay|Emergency department length of stay for participants|Measured at time of chart review for patient follow-up, approximately 4 weeks after enrollment.||||minutes||Full Range|Median
1313577|NCT02475733|Secondary|Percentage of Participants With Emergent Infections at Test of Cure (TOC) Visit: Microbiologically Evaluable Population|Emergent Infections was an intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy, new infection was an intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment has finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). Participants with any (super infections or new infections) of the infections were reported.|TOC visit (up to a maximum study duration of 50 days)|ME analysis population included randomized participants with cIAI who received study medication for >=48 h and clinical failure or clinical failure with treatment limiting AE and participants with >=72 h treatment and favorable microbiological response.|||percentage of participants|||Number
1313578|NCT02475733|Secondary|Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population|Emergent infections were categorized as super infections and new infections. Superinfection: An intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: An intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Participants with any (super infections or new infections) of the infections were reported.|Baseline up to 50 days|Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.|||percentage of participants|||Number
1313579|NCT02475733|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Population|A participant was said to have clinical relapse if me either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|LFU visit (up to a maximum study duration of 50 days)|ME analysis population included randomized participants with cIAI who received study medication for >=48 h and clinical failure or clinical failure with treatment limiting AE and participants with >=72 h treatment and favorable microbiological response. Here, number of participants analyzed=participants who were evaluable for this measure.|||percentage of participants|||Number
1313580|NCT02475733|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Population|A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|LFU visit (up to a maximum study duration of 50 days)|CE analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable clinicial response. Here, number of participants analyzed=participants who were evaluable for this measure.|||percentage of participants|||Number
1313581|NCT02475733|Secondary|Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population|Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)|ME analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable microbiological response.|||percentage of participants|||Number
1313582|NCT02475733|Secondary|Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population|Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)|Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.|||percentage of participants|||Number
1313593|NCT02475733|Primary|Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms)|ECG parameters included maximum QT intervals using Fridericia’s correction (QTcF). Maximum QTcF >450 millisecond (ms); maximum QTcF >480 ms; and maximum QTcF >500 ms. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline until the EOIV visit (anytime from Day 4 to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313616|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.|Day 8|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||participants|||Number
1313583|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|End of 72 hours study drug treatment on Day 1, EOIV (anytime from Day 4 up to 16), EOT visit (up to Day 17) and TOC visit (up to a maximum study duration of 50 days)|CE analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable clinicial response.|||percentage of participants||95% Confidence Interval|Number
1313584|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC) Visit: Intent-to-treat (ITT) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1313585|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT) Visit: Intent-to-treat (ITT) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy).|EOT visit (up to Day 17)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1313586|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at End of Intravenous Therapy (EOIV) Visit: Intent-to-treat (ITT) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 up to 16)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1313587|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at End of 72 Hours Treatment: Intent-to-treat (ITT) Analysis Population|Favorable CR was defined as resolution of all acute signs and symptoms of complicated intra- abdominal infection (cIAIs), or improvement to such an extent that no further antimicrobial therapy was required, or improvement but not enough to switch to oral therapy and still on IV study drug at end of 72 hours and had met following criterion: absence of new signs and symptoms, improvement in at least 1 symptom/sign (fever, pain, tenderness, elevated White Blood Cells [WBCs], elevated c-reactive protein) from baseline and no worsening symptom/sign.|End of 72 hours study drug treatment on Day 1|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1313588|NCT02475733|Secondary|Plasma Concentrations of Ceftazidime and Avibactam||15, 30-90, 300-360 minutes post-dose on Day 3|PK analysis set included all randomized participants who received any amount of study medication and had at least 1 CAZ and/ or AVI plasma measurement available. This outcome measure was not planned to be analyzed for meropenem receiving cohorts, as pre-specified in protocol.|||nanogram per milliliter||Standard Deviation|Geometric Mean
1313589|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit|CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication.|||percentage of participants|||Number
1313590|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit|CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313591|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit|CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313617|NCT02475031|Secondary|Sedation Scores at 48 Hours|Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep.|48 hours||||units on a scale||Standard Error|Mean
1313594|NCT02475733|Primary|Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters|Criteria for potentially clinically significant laboratory abnormalities: Chemistry (calcium: <0.7*lower limit of normal range [LLN] and >30 percent decrease from baseline [DFB]; alanine aminotransferase [ALT]: >3*upper limit of normal range [ULN] and >300 percent IFB; alanine aminotransferase [AST]: >3*ULN and >300 percent IFB) and hematology (platelets: >2*ULN and >100 percent IFB). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313595|NCT02475733|Primary|Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit|Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer’s discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313596|NCT02475733|Primary|Change From Baseline in Body Temperature at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||degree Celsius||Standard Deviation|Mean
1313597|NCT02475733|Primary|Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||kilograms||Standard Deviation|Mean
1313598|NCT02475733|Primary|Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||breaths per minute||Standard Deviation|Mean
1313599|NCT02475733|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1313600|NCT02475733|Primary|Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||beats per minute||Standard Deviation|Mean
1313601|NCT02475733|Primary|Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)|Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of seizures, diarrhea, renal disorder, and liver disorder relevant to the cephalosporin class within the ST and AEs with preferred term in the system organ class of nervous system disorder system organ class based on MedDRA 20.0) were reported in this outcome measure.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313602|NCT02475733|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 35 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
1313603|NCT02475564|Secondary|Serum Prolactin Levels at 42 Days|Serum levels of prolactin will be measured after 42 days of treatment. Median levels of prolactin were compared between both groups on day 42.|42 days|one of the subjects in the placebo group decided to leave the study after randomization, thus n = 21|||ng/mL||Full Range|Median
1313604|NCT02475564|Secondary|Serum CA125 Levels at 42 Days|Serum levels of CA125 will be measured after 42 days of treatment in UI/mL. Median levels of CA125 were compared between both groups on day 42, and to baseline values (day 1).|42 days|One of subjects from the placebo group decided to leave the study after randomization, thus the n = 21 in the CA125 levels.|||UI/mL||Full Range|Median
1313605|NCT02475564|Primary|Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.|Pain will be measured by VAS (visual analog scale) as baseline and at the end of the study, considering the last 7 days. VAS was used to measuring pain intensity, ranging continuously from 0 (no pain) to 10 (worst imaginable pain). The main outcome compared median pain levels between both arms on day 42.|42 days|Intention to treat analysis, patients who were lost on follow-up had their last registry on pain values or plasma levels measurements repeated in the following consultations.|||units on a scale||Full Range|Median
1317272|NCT02368314|Secondary|Frequency of Death From Other Causes||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1313606|NCT02475395|Secondary|Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.|Healthcare professions obtained a categorical sperm concentration result by performing assay on aliquot obtained from Lay User's sample. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.|Participants will be followed for one visit for up to 2 hours|One fewer was analyzed in this population because a sample did not have enough sample to allow the HCP to run the test.|||Participants|||Count of Participants
1313607|NCT02475395|Secondary|Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.|Healthcare professions obtained a categorical sperm concentration result by observing completed assay outputs as performed by Lay Users. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.|Participants will be followed for one visit for up to 2 hours||||Participants|||Count of Participants
1313608|NCT02475395|Primary|Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard|Lay users obtained categorical sperm concentration result. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Gold standard reference (analysis by Computer-aided Semen Analysis [CASA]) result was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match gold standard reference category result.|Participants will be followed for one visit for up to 2 hours||||Participants|||Count of Participants
1313609|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 29 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.|Day 29|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||participants|||Number
1313610|NCT02475278|Secondary|Percentage of Participants Experiencing Serious Adverse Events|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 183|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
1313611|NCT02475278|Secondary|Percentage of Participants With Unsolicited Adverse Events (AEs) by Maximum Severity|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Unsolicited AEs are presented as the percentage of participants experiencing at least one AE, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 28|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
1313612|NCT02475278|Secondary|Percentage of Participants With Elevated Daily Oral Temperature|Safety assessment included measurement of body temperature for 7 days following vaccination (including the day of vaccination) by using diary cards. Participants recorded the highest body temperature observed each day in a daily diary. The highest body temperature measurement per participant across Day 1 to Day 7 was categorized as fever present (≥100.4ºF, ≥38ºC) or fever absent (<100.4ºF, <38ºC).|Days 1 to 7 days after vaccination|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
1313613|NCT02475278|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited systemic AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting and diarrhea and are summarized as either none or any, where ‘any’ will be broken down into the following severity categories: mild, moderate, severe. Solicited systemic AEs are presented as the percentage of participants experiencing a solicited systemic AE, by AE, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
1313614|NCT02475278|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited local AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited local injection site AEs are defined as pain, erythema (redness), induration and swelling. Pain is summarized as either none or any, where ‘any’ will be broken down into the following severity categories: mild, moderate, severe. Erythema, swelling and induration are recorded as yes or no, where the definition of ‘yes’ is any area ≥2.5 cm; and ‘yes’ is further broken down into the following severity categories: ≥2.5 cm - ≤5.0 cm (mild intensity), >5.0 cm - ≤ 10.0 cm (moderate intensity), >10.0 cm severe intensity). Injection site AEs are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
1313615|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 15 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.|Day 15|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||participants|||Number
1313622|NCT02474901|Other Pre-specified|Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness.|Compare numbers of participants with influenza diagnosed by PCR and with clinically-diagnosed influenza between the two groups. Data was taken from Influenza Infection Questionnaires #1 and #2. The last questionnaire (#2) was administered between May 15 and June 10, 2014 (after the vaccine). Data is reported as PCR-confirmed influenza and clinically-diagnosed influenza (subject told had influenza without confirmatory testing).|up to 11 months post-vaccination|Number of participants analyzed reflects the number of subjects who participated in the end-of-season interview.|||Participants|||Count of Participants
1313623|NCT02474901|Secondary|Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.|The investigators will measure hemagglutinin inhibition (HAI) on blood samples #2 (14-21 days after vaccination) for all participants. The investigators will also compare the number of participants reaching HAI ≥ 40 for each virus sub-type contained in the vaccine.|14-21 days|The total number of participants analyzed reflect the number of subjects for whom there was a blood sample from the 4th visit at day 14-21.|||Participants|||Count of Participants
1313624|NCT02474901|Secondary|Number of Participants With Adverse Events Within 14 Days After Vaccination|The investigators will compare the number of adverse events (AE) reported by AE category within 14 days after vaccination as reported by each participant. Data will reflect whether a participant ever reported the AE, and not the number of times the AE was reported.|14 days after vaccination for AEs; up to 30 days for unscheduled visits||||Participants|||Count of Participants
1313625|NCT02474901|Primary|Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups.|Measure PCR positivity for any of the influenza subtypes included in QLAIV at visit 1 (day 0), visit 2 (days 2-5), visit 3 (days 7-10) and visit 4 (days 14-21). Compare number of participants with shedding for any subtype in each patient group. (The study was powered based on the 7-10 day data.)|day 0-21 post-vaccine|Subjects with data for any of the visits|||Participants|||Count of Participants
1313626|NCT02474901|Primary|Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV in the First 21 Days After Vaccine Administration Days in HIV-positive and Control Groups.|Measure PCR positivity for any of the influenza subtypes included in QLAIV between baseline (day 0) and the last study visit at 14-21 days after vaccine. Compare number of participants with PCR positivity for any of the vaccine-strain influenza virus strains in each patient group.|21 days|HIV-infected and uninfected recipients of QLAIV; one HIV-uninfected subject was lost-to-follow-up after the first follow-up visit following vaccination.|||Participants|||Count of Participants
1313627|NCT02474589|Primary|To Determine the Number of Participants With Adverse Events|To determine the safety and tolerability of oral tecovirimat|45 days||||Participants|||Count of Participants
1313628|NCT02474498|Secondary|Relative Gingival Margin Position (RGMP) at 12 Months||12 months||||mm||Standard Deviation|Mean
1313629|NCT02474498|Secondary|Periodontal Probing Depth at 12 Months||12 months||||mm||Standard Deviation|Mean
1313630|NCT02474498|Secondary|Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months|The relative vertical clinical attachment level (RVCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced vertically into the buccal periodontal pocket. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.|12 months||||mm||Standard Deviation|Mean
1313631|NCT02474498|Primary|Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months|The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.|12 months||||mm||Standard Deviation|Mean
1313632|NCT02474082|Secondary|Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24|"SF-36 is a generic indicator of health status for use in population surveys and evaluative studies of health policy. The SF-36 included 36 items in a Likert-type or forced-choice format measured on eight dimensions. The scores for each domain range from 0 to 100, with high scores indicating a better status. SF-36 responder is defined as subject reaching at least an improvement of minimum important difference (MID). The SF-36 measure dimensions and their MID includes:~Physical Functioning:4.3~Role-Physical: 3.4~Bodily Pain: 6.2~General Health: 7.2~Vitality: 6.2~Social Functioning: 6.9~Role-Emotional: 4.5~Mental Health: 6.2~Two component scores and their MID which were derived from the above mentioned 8 domains includes-:~Physical component summary: 3.4~Mental component summary: 4.6"|Week 4, 16 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for SF-36 response at week 4, 16 and 24|||Percentage of participants|||Number
1313633|NCT02474082|Secondary|Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life. DLQI 0/1 response was the achievement of a DLQI score of 0 or 1.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population.|||Percentage of participants|||Number
1313667|NCT02473523|Other Pre-specified|Median Change in Balance|Median (range) on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313668|NCT02473523|Other Pre-specified|Mean Change in Balance|Mean ± standard error on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313634|NCT02474082|Secondary|Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). “Not relevant” was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for DLQI at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Score on a scale||Standard Deviation|Mean
1313635|NCT02474082|Secondary|Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. IGA 0/1 responders: who achieved score of 0/1 and improved by at least 2 points on the IGA scale compared to baseline.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population.|||Percentage of participants|||Number
1313636|NCT02474082|Secondary|Number of Participants With Investigator’s Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|IGA mod 2011 is a global static severity rating scale referring exclusively to the participant’s disease state at the time of the assessments and don’t attempt comparison with participant’s any previous disease states at baseline or visit. IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. Scores used were: 0/Clear: no signs of psoriasis, Post-inflammatory hyperpigmentation may be present; 1/almost clear: Normal to pink coloration of lesions/no thickening/no to minimal focal scaling; 2/Mild: Pink to light red coloration/just detectable to mild thickening/predominantly fine scaling; 3/Moderate: Dull bright red, clearly distinguishable erythema/clearly distinguishable to moderate thickening/moderate scaling; 4/Severe: Bright to deep dark red coloration/severe thickening with hard edges/severe or coarse scaling covering almost all or all lesions.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies the participants evaluable for IGA mod 2011 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Participants|||Count of Participants
1313637|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 100 responders were participants who PASI 100 responders were participants who achieved complete clearance of psoriasis.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 100 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
1313638|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 90 responders were participants who achieved >=90% improvement (reduction) in NPASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 90 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
1313639|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 75 responders were participants who achieved >=75% improvement (reduction) in NPASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies participants evaluable for NAPSI 75 at week 1, 2, 3, 4, 5, 6, 8,12,16, 20 and 24.|||Percentage of participants|||Number
1313669|NCT02473523|Other Pre-specified|Median Change in Hamstring Flexibility|Hamstring flexibility will be assessed by the Sit and Reach Test. Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313640|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0–4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, “oil drop” (salmon patch dyschroma). NPASI 50 responders were participants who achieved >=50% improvement (reduction) in NPASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here ‘number analyzed’ signifies participants evaluable for NAPSI 50 at week 1, 2, 3, 4, 5, 6, 7,12,16, 20 and 24.|||Percentage of participants|||Number
1313641|NCT02474082|Secondary|Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The Body surface area (BSA) affected by plaque-type psoriasis was the total of percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages were added to estimate the total BSA affected by plaque-type psoriasis.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for BSA at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of area||Standard Deviation|Mean
1313642|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 100 responders were participants who achieved complete clearance of psoriasis (PASI=0).|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 100 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
1313643|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 90 responders were participants who achieved >=90% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 90 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
1313644|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16 and 20|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 75 at week 1, 2, 3, 4, 6, 8, 12, 16 and 20.|||Percentage of participants|||Number
1313645|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 50 responders were participants who achieved >=50% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 50 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
1313670|NCT02473523|Other Pre-specified|Mean Change in Hamstring Flexibility|Hamstring flexibility will be assessed by the Sit and Reach Test. Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313671|NCT02473523|Other Pre-specified|Median Change in Grip Strength|"A calibrated Jamar hydraulic hand dynamometer will be used to measure grip strength. Median (range) will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1313646|NCT02474082|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 24|The analysis was performed in Full analysis set (FAS) population, defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1313647|NCT02473991|Primary|Placental Thickness at 3rd Trimester||30-34 weeks of pregnancy||||millimeter||Standard Deviation|Mean
1313648|NCT02473991|Primary|Placental Thickness in Second Trimester|placental thickness measured in millimeter|15-20 weeks of gestation||||millimeter||Standard Deviation|Mean
1313649|NCT02473991|Primary|Fetal Weight (Fetal Weight at Birth)|Fetal weight (fetal weight at birth) (in grams)|9 months||||gram||Standard Deviation|Mean
1313650|NCT02473783|Secondary|Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution|Pain Scores as measured by the Visual Analog Scale (0-10) for the tolerability of injection of I-123-ADAM solution. Higher values represent a worse outcome.|assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)|All the participants in the Intention -to-treatment group completed the study.|||units on a scale||Standard Deviation|Mean
1313651|NCT02473783|Secondary|Hamilton Depression Rating Scale (HAM-D) Total Scores|The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. It contains 17 items to be rated. Each item on the questionnaire is scored on a 3 or 5 point scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression.|6 weeks|All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.|||units on a scale||Standard Deviation|Mean
1313652|NCT02473783|Primary|The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)|Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region － cerebellum) / cerebellum)|6 weeks (The Healthy control Group only had the scanning at baseline)|All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.|||a ratio of target region to background||Standard Deviation|Mean
1313653|NCT02473718|Secondary|Mortality|Percentage of patients who died during their ICU stay|ICU stay, median of 10 days||||Participants|||Count of Participants
1313654|NCT02473718|Secondary|Mortality|Percentage of patients who died during their hospitalization|Hospital stay, median of 16 days||||Participants|||Count of Participants
1313655|NCT02473718|Secondary|Rate of Renal Replacement Therapy|Percentage of patients requiring renal replacement therapy|ICU stay, median of 10 days||||Participants|||Count of Participants
1313656|NCT02473718|Secondary|Ventilator Days|Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation|Hospital stay, median of 16 days||||days||Inter-Quartile Range|Median
1313657|NCT02473718|Primary|Net Fluid Balance|Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5|Day 5||||mL||Inter-Quartile Range|Median
1313658|NCT02473718|Primary|Net Fluid Balance|Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3|Day 3||||mL||Inter-Quartile Range|Median
1313659|NCT02473718|Primary|Cumulative Fluid Administered|Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5|Day 5|Five patients in the fluid minimization group and four patients in the usual care group died prior to analysis at day 5. Five patients in the fluid minimization group and six patients in the usual care group were transferred out of the ICU prior to analysis at day 5.|||mL of study fluid||Inter-Quartile Range|Median
1313660|NCT02473718|Primary|Cumulative Fluid Administered|Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3|Day 3|Five patients in the fluid minimization group and two patients in the usual care group died prior to the first time point analysis at day three. One patient in the usual care group was transferred out of the ICU prior to the first time point analysis at day 3.|||mL of study fluid||Inter-Quartile Range|Median
1313661|NCT02473640|Primary|Ribaxamase Concentration in Intestinal Chyme Period 2|Concentrations of ribaximase (SYN-004) in intestinal chyme|0-8.5 hours||||ng/mL||Standard Error|Mean
1313662|NCT02473640|Primary|Ceftriaxone Concentration in Intestinal Chyme Period 2|Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.|0-8.5 hours|Subjects with functioning illeostomies who received a single IV infusion of 1 g ceftriaxone.|||ug/mL||Standard Error|Mean
1313663|NCT02473640|Primary|Ribaxamase Concentration in Intestinal Chyme Period 1|Concentrations of ribaximase (SYN-004) in intestinal chyme|0-8.5 hours||||ng/mL||Standard Error|Mean
1313664|NCT02473640|Primary|Ceftriaxone Concentration in Intestinal Chyme Period 1|Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.|0-8.5 hours|Subjects with functioning illeostomies who received a single IV infusion of 1 g ceftriaxone.|||ug/mL||Standard Error|Mean
1313665|NCT02473523|Other Pre-specified|Median Change in Verbal Numeric Pain Scale|Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
1317273|NCT02368314|Secondary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1313679|NCT02473523|Primary|Rate of Patients Who Complete the Study|The rate of enrolled and consented patients who complete the 60-minute yoga sessions offered over a 4-6 week period to the total number of participants on the study. It is hypothesized that 60% of those participants will complete the intervention. Thus, if more than 5 patients can not complete the intervention, then it will be concluded that the trial is not feasible.|At end of 4-6 weeks|||||||
1313680|NCT02473523|Primary|Rate of Patients Who Are Willing to Participate|The rate of participants who are willing to participate on this protocol to the total number of participants approached. It is anticipated that 50% approached patients will agree to participate on the study. Twenty five patients will be approached and asked to participate in the study. If more than 6 patients out of 25 approached patients refuse to participate in the study, the study will be closed, and it will be concluded that the trial is not feasible.|Day 0|||||||
1313681|NCT02473510|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of Participants|||Number
1313682|NCT02473510|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported within 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and 181|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
1313683|NCT02473510|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported within 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
1313684|NCT02473510|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 8 days after vaccination and all solicited symptoms within 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of Participants|||Number
1313685|NCT02473510|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.|||Percentage of Participant|||Number
1313686|NCT02473471|Secondary|Menstrual Cycle|the relationship between the rate of tooth movement and Menstrual cycle|within 3 months|Sufficient data were not collected from any participant||||||
1313687|NCT02473471|Secondary|Patient Satisfaction|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction.|After 7 days of MOP application||||units on a scale||Standard Deviation|Mean
1313688|NCT02473471|Secondary|Pain Interference /Discomfort|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
1313689|NCT02473471|Secondary|Pain Interference /Swelling of the Surgical Side|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
1313690|NCT02473471|Secondary|Pain Interference /Pain Interrupted Sleep|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
1313691|NCT02473471|Secondary|Pain Interference /Pain During Eating?|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
1313692|NCT02473471|Secondary|Pain Intensity|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
1313693|NCT02473471|Secondary|Root Resorption|It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period|Baseline to 3rd month||||mm||Standard Deviation|Mean
1313694|NCT02473471|Primary|Intra Oral Measurements of Canine Rate of Tooth Movement|Direct intraoral measurement of the distance between canine and second premolar in the patient’s mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.|Baseline to 3 month|32 subjects were analyzed who received MOP to either right or left sides.|||mm||Standard Deviation|Mean
1313919|NCT02467075|Secondary|Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition|Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity|48-72 hours||||Participants|||Count of Participants
1313695|NCT02473471|Primary|Intra Oral Measurements of Canine Rate of Tooth Movement|Direct intraoral measurement of the distance between canine and second premolar in the patient’s mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.|Baseline to 2nd month|32 subjects were analyzed to receive MOP to either right or left sides.|||mm||Standard Deviation|Mean
1313696|NCT02473471|Primary|Intra Oral Measurements of Canine Rate of Tooth Movement|Direct intraoral measurement of the distance between canine and second premolar in the patient’s mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.|Baseline to 1st month|32 subjects were analyzed to receive MOP to either right or left sides. Only one patient was lost to follow up at the first month time point.|||mm||Standard Deviation|Mean
1313697|NCT02473471|Primary|3D Digital Model Measurements of Canine Rate of Tooth Movement|The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.|Baseline to 3rd month|Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion, and only one impression was lost to be taken by a clinician at two months.|||mm||Standard Deviation|Mean
1313698|NCT02473471|Primary|3D Digital Model Measurements of Canine Rate of Tooth Movement|The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.|Baseline to 2nd month|Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. only one impression was lost to be taken by a clinician at two months period.|||mm||Standard Deviation|Mean
1313699|NCT02473471|Primary|3D Digital Model Measurements of Canine Rate of Tooth Movement|The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.|Baseline to 1st month|Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion.|||mm||Standard Deviation|Mean
1313700|NCT02473445|Secondary|Change Over Time in Pharmacodynamic Biomarkers|Change from baseline in glutathione, glutathione disulfide, and lactate analyses were not performed as the study was prematurely terminated.|Baseline, every 3 months and Study Exit (up to 24 Months)|The study was closed prematurely due to lack of efficacy demonstrated in base study RP103-MITO-001. As a result, only a limited amount of data was collected for patients that were enrolled prior to termination. The decision was made that the data were not complete enough, and no analyses were conducted.||||||
1313701|NCT02473445|Secondary|Change Over Time in Two of the Most Pre-eminent Symptoms|The two pre-eminent symptoms previously identified in study RP103-MITO-001 were to be continued to be assessed during the extension study. Symptoms included myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision.|Baseline, every 3 months and Study Exit (up to 24 Months)|The study was closed prematurely due to lack of efficacy demonstrated in base study RP103-MITO-001. As a result, only a limited amount of data was collected for patients that were enrolled prior to termination. The decision was made that the data were not complete enough, and no analyses were conducted.||||||
1313702|NCT02473445|Primary|Change in Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Score|"The NPMDS evaluates the progression of mitochondrial disease in pediatric patients in 4 domains:~I - Current Function (vision, hearing, communication, feeding, and mobility) with scores ranging from 0 to 21;~II - System Specific Involvement (seizures, encephalopathy, bleeding diathesis or coagulation defects, gastrointestinal, endocrine, respiratory, cardiovascular, renal, liver, and blood) with scores ranging from 0 to 30.~III - Current Clinical Assessment (growth and development over past 6 months, vision, strabismus and eye movement, myopathy, ataxia, pyramidal, extrapyramidal, and neuropathy) with scores ranging from 0 to 28;~IV - Quality of Life with scores ranging from 0 to 25. For sections I-III, higher scores reflect more severe disease. For Section IV, a higher score reflects a lower quality of life."|Baseline, every 3 months and Study Exit (up to 24 Months)|The study was closed prematurely due to lack of efficacy demonstrated in base study RP103-MITO-001. As a result, only a limited amount of data was collected for patients that were enrolled prior to termination. The decision was made that the data were not complete enough, and no analyses were conducted.||||||
1313703|NCT02473367|Primary|Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
1313714|NCT02472886|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1313715|NCT02472886|Secondary|HCV RNA Change From Day 1||Up to 12 weeks|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1313716|NCT02472886|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 weeks|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1313704|NCT02473367|Primary|Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
1313705|NCT02473367|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.|||hr*µM||95% Confidence Interval|Least Squares Mean
1313706|NCT02472977|Primary|Number of Participants With Electrocardiogram Abnormalities|The number of participants experiencing electrocardiogram abnormalities was reported for each arm|From first dose to date of last dose plus 30 days|Electrocardiogram data was not collected for any participants||||||
1313707|NCT02472977|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.|From first dose to date of progression (assessed up to January 2017, approximately 18 months)|PFS data was not collected for any participants||||||
1313708|NCT02472977|Primary|Number of Participants With Laboratory Abnormalities|The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.|From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)|All treated participants in PAC arms. Lab abnormality data was not collected for SCLC arm.|||Participants|||Number
1313709|NCT02472977|Primary|Overall Survival (OS)|If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.|From date of randomization to date of death (assessed up to study completion, approximately 18 months)|OS data was not collected for any participants||||||
1313710|NCT02472977|Primary|Objective Response Rate (ORR) Per RECIST 1.1 Criteria|ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.|From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)|All treated participants in PAC arms. ORR data was not collected for SCLC arm.|||Percentage of participants||90% Confidence Interval|Number
1313711|NCT02472977|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs|The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.|From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)|All treated participants. Participants in the SCLC (Tot) Arm were not evaluated for Immune-mediated AEs|||Participants|||Number
1313712|NCT02472886|Secondary|For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4||Up to Posttreatment Week 4|Participant in the Safety analysis set (with or without prior antiretroviral (ARV) treatment) with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1313713|NCT02472886|Secondary|Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4||Up to Posttreatment Week 4|Participants in the Safety Analysis Set (who had HIV RNA < 50 Copies/mL at baseline) with available data were analyzed.|||percentage of participants|||Number
1313717|NCT02472886|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1313718|NCT02472886|Primary|Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1313719|NCT02472886|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1313720|NCT02472847|Primary|BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean BOLD hippocampal signal during extinction learning and retention task in brain responsebetween the placebo (PBO) and the dronabinol (THC) group. Target areas are analyzed from fMRI scans. The scans were completed on days 1, 2, 3, and 9. Participants were randomized to the PBO and THC condition and received either placebo or dronabinol on day 2, 2 hours prior to extinction learning. Data from days 1, 2, 3, & 9 was combined and a single value was averaged for each group.|Day 1, 2, 3, & 9|The number of participants analyzed is 22 in the placebo group and 18 in the dronabinol group. The total number of participants who completed all 4 scanning sessions is 44. 4 participants were excluded from data analysis due to having poor quality fMRI data from any of the four sessions.|||parameter estimates (arbitrary units)||Standard Deviation|Mean
1313721|NCT02472756|Primary|Percentage of Participants Who Were Alive at Year 2||Year 2|ITT population.|||percentage of participants|||Number
1313722|NCT02472756|Primary|Percentage of Participants With Complete Remission (CR)|Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline).|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1313723|NCT02472756|Primary|Percentage of Participants With Objective Response|Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD.|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|Intent-to treat (ITT) population. Number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1313724|NCT02472639|Secondary|Dehydration Related Hospital Admissions During Study Period|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
1313725|NCT02472639|Secondary|Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
1313726|NCT02472639|Secondary|Number of Ostomy Bag Breakages During the Study Period|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
1313727|NCT02472639|Secondary|Overall Satisfaction With Ostom-i Device|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
1313728|NCT02472639|Primary|Patient Quality of Life as Measured by the 20-item Stoma-QOL Questionnaire at 1 Month and 3 Month Follow-up After Using the Ostomi-I Alert Versus Standard Stoma Care Without the Ostom-i Alert.||up to 3 Months|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.||||||
1313729|NCT02472522|Post-Hoc|Percentage of Patients Needing Rescue Analgesic|Percentage of patients needing rescue analgesic. Rescue analgesia was provided with 6 mg of intravenous morphine and additional doses of 3 mg at 10 minutes interval till VAS was less than 3 or the development of adverse effects such as nausea and/or vomiting, respiratory depression (SpO2 <92%, ventilatory frequency rate <10), or occurrence of deep sedation (eyes closed >3 min, Ramsay Score RS >2).|24 hours||||percentage needing rescue analgesic|||Number
1313730|NCT02472522|Other Pre-specified|Short Assessment of Patient Satisfaction Score (SAPS)|"Short assessment of patient satisfaction score(SAPS) was assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. where:~highly dissatisfied~dissatisfied~neither dissatisfied nor satisfied~satisfied~highly satisfied"|24 hours||||Units on a scale||Standard Deviation|Mean
1313731|NCT02472522|Other Pre-specified|Visual Analogue Scale on Coughing (VAS-C)|Visual Analogue Scale on Coughing (VAS-C) Was Used to Assess Post-operative Pain on Coughing. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours||||Units on a scale||Standard Deviation|Mean
1313732|NCT02472522|Other Pre-specified|Visual Analogue Scale at Rest (VAS-R)|Visual Analogue Scale at rest (VAS-R) was used to assess Post-operative Pain at rest. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours||||Units on a scale||Standard Deviation|Mean
1313733|NCT02472522|Other Pre-specified|Heart Rate: Postoperative|The Heart Rate of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours||||beats/minute||Standard Deviation|Mean
1313734|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Postoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours||||millimeter of mercury (mmHg)||Standard Deviation|Mean
1313735|NCT02472522|Other Pre-specified|Duration of Sensory Loss at T10 Level|The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes.|24 hours||||minutes||Standard Deviation|Mean
1317274|NCT02368314|Secondary|Frequency of Symptomatic Nonlethal PATE||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1313736|NCT02472522|Other Pre-specified|Time to Complete Disappearance of Motor Block|"During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles~= able to move knees, unable to raise extended legs~= able to flex ankles, unable to flex knees~= unable to move any part of the lower limb The time from subarachnoid block to complete disappearance of motor block (Bromage 0) was recorded in minutes."|24 hours||||minutes||Standard Deviation|Mean
1313737|NCT02472522|Other Pre-specified|Heart Rate: Intraoperative Period|The Heart Rate of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|60 minutes||||beats/minute||Standard Deviation|Mean
1313738|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Intraoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|Upto 60 minutes||||millimeter of mercury (mmHg)||Standard Deviation|Mean
1313739|NCT02472522|Secondary|Adverse Effects Like Pruritus, Nausea and Vomiting||24 hours||||participants|||Number
1313740|NCT02472522|Secondary|Total Dose of Required Morphine in 24 Hours Postoperatively||24 hours|Only the mentioned number of patients needed analgesia within the first 24 hours postoperatively|||Milligrams||Standard Deviation|Mean
1313741|NCT02472522|Primary|The Time After the TAP Block When Rescue Analgesia Was First Sought||24 hours|Number of patients who sought rescue analgesic within the first 24 hours postoperatively. Rest of the studied patients needed no rescue analgesic within the first 24 hours postoperatively.|||Hours||Standard Deviation|Mean
1313742|NCT02472405|Primary|POSAS (The Patient and Observer Scar Assessment Scale) Measure|POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.|2 months|The measurement used for this outcome was completed 4 weeks post final intervention, only eight participants completed the study protocol, but only 6 participant's POSAS score was collected. Observer's score for the POSAS is not available. Only the score for the participants was reported.|||Score||Standard Deviation|Mean
1313743|NCT02472366|Post-Hoc|Change in Best Corrected Visual Acuity From Baseline|A subgroup analysis was performed in which only pseudophakic subjects were included. Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"|||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
1313744|NCT02472366|Secondary|Changes in Macular Volume||Change from Baseline to 12 months post ILUVIEN administration|"For laser arm group, 6 patients were enrolled with 7 eyes receiving ILUVIEN"|||mm^3|Participants|Standard Deviation|Mean
1313745|NCT02472366|Secondary|Changes in Central Subfield Thickness||Change from Baseline to 12 months post ILUVIEN administration|"For Laser arm group, there were 6 patients enrolled but 7 eyes treated"|||microns|Participants|Standard Deviation|Mean
1313746|NCT02472366|Secondary|Changes in Intraocular Pressure (IOP)||Change from Baseline to 12 months post ILUVIEN administration|"for laser arm group, 6 patients enrolled with 7 eyes receiving ILUVIEN"|||mmHg|Participants|Standard Deviation|Mean
1313747|NCT02472366|Primary|Changes in Best Corrected Visual Acuity From Baseline|Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"|||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
1313748|NCT02471755|Secondary|Change of E2 From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||pmol/l||Inter-Quartile Range|Median
1313749|NCT02471755|Secondary|Change of FSH/LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||ratio||Inter-Quartile Range|Median
1313750|NCT02471755|Secondary|Change of LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||mIU/ml||Inter-Quartile Range|Median
1313751|NCT02471755|Secondary|Change of FSH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||mIU/ml||Inter-Quartile Range|Median
1313752|NCT02471755|Secondary|Change of MRS (Menopause Rating Scale) From Baseline|MRS(Menopause Rating Scale) was designed to measure MT symptoms and to explore the influences on life qualities in a standardized way. In MRS, symptoms such as impaired memory, depression, insomnia, sweating, hot flashes, nervousness, joints complaints, lack of concentration were evaluated and calculated in numbers to describe the situation of patient. Scores on MRS range from 0 to 44, with higher scores indicating more severe symptoms.|week8;wee4,20,32||||Scores on a scale||Inter-Quartile Range|Median
1313753|NCT02471755|Primary|Change of Average 24 h Hot Flash Score From Baseline|Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.|week8;wee4,20,32||||Scores on a scale||Inter-Quartile Range|Median
1313755|NCT02471612|Secondary|Number of Participants With Acute Kidney Injury (AKI)|"Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines~Increase in Serum Creatinine (S. Cr) by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR~Increase in S. Cr to ≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR~Urine volume <0.5 ml/kg/h for 6 hours"|30 days||||participants|||Number
1313756|NCT02471612|Secondary|Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)|Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment|30 days||||participants|||Number
1313757|NCT02471612|Secondary|Need for Post Operative Inotropic Support|Number of patients needing post-operative inotropic support|30 days||||participants|||Number
1313758|NCT02471612|Secondary|Need for Postoperative Ventilator Support|Number of patients needing post-operative ventilatory support|30 days||||participants|||Number
1313759|NCT02471612|Secondary|Length of Stay (LOS)|The mean duration of hospital stay or Length of Stay was recorded|30 days||||Days||Standard Deviation|Mean
1313760|NCT02471612|Primary|Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality|Participants will be followed for the duration of hospital stay (expected average of 30 days) and mortality was noted.All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II and P-POSSUM scoring systems on the day of surgery. Area under the curve (AUC) is used to measure the “size” of the prediction composed by the graphic display between the ‘sensitivity’ and the ‘1–specificity’ relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value > 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value < 0.60 is regarded as poor. For APACHE-II, a cut off score of >/=24 was determined; for P-POSSUM, a cut off score of >/= 63 was determined.|30 days|All patients undergoing emergency laparotomy at Tata Main Hospital form December 2013 to November 2014 were scored with APACHE II & P-POSSUM scoring systems on the day of surgery. The patients were followed up till at least 30 days after discharge or death (during admission or within 30 days after discharge).|||probability of accurate prediction||95% Confidence Interval|Number
1313761|NCT02471326|Secondary|Subjects Who Met Criteria to Restart Antiretroviral Therapy|The secondary endpoint was the number of subjects who met protocol defined virologic (sustained HIV RNA >1000 copies/mL by Abbott HIV RTPCR at 2 consecutive visits), immunologic (a confirmed >30% decline in CD4 cell count or an absolute CD4 cell count < 350 cells/mm3), or clinical criteria (HIV-related symptoms) to discontinue VRC01 infusions and restart Antiretroviral Therapy (ART).|From Day 3 post initial infusion until up to 28 weeks.|The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).|||Participants|||Count of Participants
1313762|NCT02471326|Primary|Number of Grade 3 or Higher Adverse Events|The primary endpoint was the number of grade 3 or higher adverse events, including serious adverse events, that were possibly related to VRC-HIVMAB060-00-AB (VRCO1).|From the start of the initial infusion until up to 48 weeks.|The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).|||Events|||Number
1313763|NCT02471183|Other Pre-specified|Change From Baseline to Week 16 in the Treatment Satisfaction Questionnaire for Medication Questionnaire (TSQM II)|"The Treatment Satisfaction Questionnaire for Medication, Version II (TSQM II) is a validated tool that evaluate the subject's satisfaction with the study treatment. It includes a total of 11 questions related to satisfaction with treatment effectiveness, side effects,convenience, and global satisfaction.~TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment."|Baseline and Week 16||||Units on a scale||95% Confidence Interval|Median
1313764|NCT02471183|Secondary|Geometric Mean of the Ratio in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) of Week 16 to Baseline|Changes in NT-proBNP levels in plasma are expressed by the geometric mean of the ratio of Week 16 to baseline|Baseline and Week 16||||Geometric mean of the ratio||95% Confidence Interval|Geometric Mean
1313765|NCT02471183|Secondary|Percentage of Patients With Change in 6-minute Walk Distance (6MWD)|"Percentage of patients with an increase (> 8% of baseline), maintenance (+/– 8% of baseline), or decrease (< -8% of baseline) in their 6MWD (at trough) from baseline to Week 16. The ± 8% boundaries for change in 6MWD reflect the approximately 8% coefficient of variation in the reproducibility of the 6MWD.~The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWD test at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWD test at Visit 5 (Week 16)."|Baseline and Week 16||||Percentage of participants|||Number
1313766|NCT02471183|Secondary|Absolute Change in 6-minute Walk Distance (6MWD) at Trough|"The 6MWT is a non-encouraged test, which measures the distance (in meters) covered by the subject during a 6-minute walk. It is performed in a 30-meters long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed.~Absolute change from baseline to Week 16 in 6MWD is measured at trough levels of inhaled treprostinil and/or selexipag. The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWT at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWT at Visit 5 (Week 16)."|Baseline and Week 16||||meters||95% Confidence Interval|Median
1313767|NCT02471183|Secondary|Percentage of Subjects With WHO Functional Class (FC) Change From Baseline|"The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension:~Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class III (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms.~Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined."|Baseline and Week 16||||percentage of participants|||Number
1313768|NCT02471183|Primary|Time to Discontinuation of Inhaled Treprostinil.|Median time from baseline (Day1) to the end of down-titration of inhaled treprostinil is calculated|Baseline to Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||weeks||Full Range|Median
1313769|NCT02471183|Primary|Maximal Tolerated Dose|"This is the individual maximal tolerated dose (MTD) observed at Week 12 in the subjects still on selexipag at Week 16.~MTD is defined as the dose of selexipag reached with the last dose change up to Week 12"|At Week 12, in subjects still on selexipag at Week 16|Sensitivity analysis: only patients being on selexipag at week 16 are considered.|||mcg||Full Range|Median
1313770|NCT02471183|Primary|Absolute Change From Baseline Over Time in Heart Rate (HR)|Pulse rate is measured after at least 5 minutes of rest in a sitting position. Median change from baseline to pre-specified post-baseline visits are calculated.|Baseline, Week 4, Week 12, Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||beats per minute (bpm)||Full Range|Median
1313771|NCT02471183|Primary|Absolute Change From Baseline Over Time in Blood Pressure|Both systolic(SBP) and diastolic (DBP) arterial blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points. Median change from baseline to pre-specified post-baseline visits are calculated|Baseline, Week 4, Week 12, Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||mmHg||Full Range|Median
1313772|NCT02471183|Primary|Number of Subjects With Adverse Events Leading to Premature Discontinuation of Selexipag|Number of subjects with adverse events leading to premature discontinuation of selexipag is determined from the first dose of selexipag up to the last dose of selexipag|Up to 22 weeks on average|All subjects who took at least one dose of selexipag were included in the safety analyses|||Participants|||Count of Participants
1313773|NCT02471183|Primary|Percentage of Subjects With Treatment-emergent Adverse Events (AEs),|Percentage of subjects with treatment-emergent AEs (serious and non serious), regardless of relationship to selexipag|26 weeks on average (from the first dose of selexipag up to 30 days after the last dose of selexipag)|All subjects who took at least one dose of selexipag were included in the safety analyses|||Percentage of participants|||Number
1313774|NCT02471183|Primary|Percentage of Subjects With Sustained Treatment Transition|"A sustained treatment transition is considered if the 3 following criteria are met a) being on study treatment (selexipag) at Week 16, and b) not having a study treatment interruption(s) of a total of 8 days or more prior to Week 16, and c) absence of inhaled treprostinil or any prostanoid treatment after Week 8 up to Week 16.~The percentage of subjects with a sustained treatment transition is calculated with 95% confidence interval (CI) using the Clopper-Pearson method."|At Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||Percentage of participants||95% Confidence Interval|Number
1313775|NCT02470949|Primary|Percent of Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart||||percent||Standard Deviation|Mean
1313776|NCT02470949|Primary|The Macronutrient Composition of Foods Consumed|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart||||grams||Standard Deviation|Mean
1313777|NCT02470949|Primary|Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 20 minutes following the completion of their manipulated social status condition.|Administered 30 days apart||||kcal||Standard Deviation|Mean
1313778|NCT02470494|Other Pre-specified|Adverse Events|All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and/or related to the investigational device or the procedure.|Baseline and up to 90-day.||||Participants|||Count of Participants
1313779|NCT02470494|Secondary|Change in Subject's Self-Perceived Ability to Communicate.|The change in the subject's self-perceived ability to communicate with the use of the EarLens Device (CHD) when compared to baseline condition was measured using the validated Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV), which all range from 0-99%. A global score is computed by averaging the EC, RV, and BN subscores. For an individual score (either unaided alone or aided alone), a higher number indicates poorer performance, or more difficulty experienced. For this outcome measure, the difference between the average of the global unaided and aided scores is computed to determine the reduction (if any) in self-perceived difficulty, so a larger number in this outcome measure indicates better performance, as more of the difficulty has been reduced from the unaided condition by going to the aided condition.|Baseline and up to 90-day.|40 subjects available for analysis between enrollment/treatment and 90-day measurement.|||percentage of perceived benefit||Standard Deviation|Mean
1313780|NCT02470494|Secondary|Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.|10 dB (decibel) change in the average pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield (SF) thresholds measured prior to device placement and the aided soundfield thresholds measured 90-day post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds|Baseline and up to 90-day.|40 subjects available for analysis between enrollment/treatment and 90-day measurement.|||dB difference in SF Hearing Thresholds||Standard Deviation|Mean
1313781|NCT02470494|Secondary|Change in Speech Understanding in Noise.|"The change in aided speech reception thresholds (SRTs) when compared to the baseline unaided condition was measured using a validated speech test, the HINT 90.~Change in aided HINT 90 SRTs when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means."|Baseline and up to 90-day.|28 subjects available for analysis between enrollment/treatment and 90-day measurement.|||dB difference in HINT scores||Standard Deviation|Mean
1313939|NCT02465866|Primary|Time of the Last Quantifiable Concentration (Tlast)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||Hours||Standard Deviation|Mean
1313782|NCT02470494|Primary|Change in Hearing Stability Using Unaided Air Conduction Thresholds.|"Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of No Hearing Change for the subject was made if the calculated hearing changes of the subject population are 10dB or less."|Baseline and up to 90-day.|40 subjects available for analysis between enrollment and 90-day measurement.|||dB difference in Unaided Hearing||Standard Deviation|Mean
1313783|NCT02470429|Secondary|Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42|TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||seconds||Standard Error|Least Squares Mean
1313784|NCT02470429|Secondary|Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
1313785|NCT02470429|Secondary|Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
1313786|NCT02470429|Primary|Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42|The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
1313787|NCT02470403|Secondary|The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Vz/F at steady state (Vz/F, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter||Standard Deviation|Mean
1313788|NCT02470403|Secondary|The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports CLss/F at steady state (CLss/F, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter/hour||Standard Deviation|Mean
1313789|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUCtau at steady state (AUCtau, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
1313790|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUClast at steady state (AUClast, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
1313791|NCT02470403|Secondary|Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Tmax at steady state (Tmax, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hour||Full Range|Median
1313792|NCT02470403|Secondary|Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Cmax at steady state (Cmax, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
1313793|NCT02470403|Secondary|The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, ss) in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter||Standard Deviation|Mean
1313940|NCT02465866|Primary|Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||ng/mL||Standard Deviation|Mean
1313794|NCT02470403|Secondary|The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter/hour||Standard Deviation|Mean
1313795|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
1313796|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
1313797|NCT02470403|Secondary|Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hour||Full Range|Median
1313798|NCT02470403|Secondary|Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study|Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
1313799|NCT02470403|Secondary|Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose.~Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used.~The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate."|Baseline, Week 2|The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.|||percent change||80% Confidence Interval|Least Squares Mean
1313800|NCT02470403|Primary|Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death|This endpoint reports patients with at least one AE (any AE), serious AE and death|2 weeks|The safety analysis set included all subjects that received any study drug.|||Patients|||Number
1313801|NCT02470403|Primary|Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose.~Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used.~The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate."|Baseline, Week 2 (Day 14)|Pharmacodynamic set. The analysis was based on all subjects with a baseline body weight and at least one post-Baseline body weight measurement. Only data from common time points in Part 1 and Part 2 were included in the analysis, i.e., Baseline and Day 14.|||Percent change||80% Confidence Interval|Least Squares Mean
1313802|NCT02470403|Primary|Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death|This endpoint reports patients with at least one AE (any AE), serious AE and death.|12 weeks|The safety analysis set included all subjects that received any study drug.|||Patients|||Number
1313803|NCT02470403|Primary|Part 1: Percent Change in Body Weight From Baseline to Week 12|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100.~A longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate."|Baseline, Week 12 (Day 85)|The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.|||percent change||80% Confidence Interval|Least Squares Mean
1313804|NCT02470390|Primary|Terminal Elimination Half-Life (t1/2) of Fentanyl in Plasma (5 of 5)|t1/2 (h)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||h||Geometric Coefficient of Variation|Geometric Mean
1313805|NCT02470390|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Fentanyl in Plasma (4 of 5)|Tmax (h)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||h||Full Range|Median
1313806|NCT02470390|Primary|Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC 0-inf) of Fentanyl in Plasma (3 of 5)|AUC 0-inf (pg*h/mL)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter. The AUC 0-inf values were excluded where %AUC extrap was greater than 20%.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1313807|NCT02470390|Primary|Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUC 0-tlast) of Fentanyl in Plasma (2 of 5)|AUC 0-tlast (pg*h/mL)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1313808|NCT02470390|Primary|Maximum Observed Concentration (Cmax) of Fentanyl in Plasma (1 of 5)|Cmax (pg/mL)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1313809|NCT02470390|Primary|Area Under the Concentration-Time Curve From Hour 0 to Hour 6 (AUC 0-6h) of Fentanyl in Cerebrospinal Fluid (CSF) (3 of 3)||6 hrs (pre-dose, 5, 10, 20, 30, 45, & 60 min, and 2, 3, 4, & 6 hrs post-dose on Study Days 1 & 3)|The CSF PK population included all subjects who completed all study periods and Cmax was less than 5% pre-dose. The above CSF PK outcome compares nasal and sublingual fentanyl interventions.|||pg*h/mL||Standard Deviation|Mean
1313810|NCT02470390|Primary|Maximum Observed Concentration (Cmax) of Fentanyl in Cerebrospinal Fluid (CSF) (2 of 3)||6 hrs (pre-dose, 5, 10, 20, 30, 45, & 60 min, and 2, 3, 4, & 6 hrs post-dose on Study Days 1 & 3)|The CSF PK population included all subjects who completed all study periods and Cmax was less than 5% pre-dose. The above CSF PK outcome compares nasal and sublingual fentanyl interventions.|||pg/mL||Standard Deviation|Mean
1313811|NCT02470390|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Fentanyl in Cerebrospinal Fluid (CSF) (1 of 3)||6 hrs (pre-dose, 5, 10, 20, 30, 45, & 60 min, and 2, 3, 4, & 6 hrs post-dose on Study Days 1 & 3)|The CSF PK population included all subjects who completed all study periods and Cmax was less than 5% pre-dose. The above CSF PK outcome compares nasal and sublingual fentanyl interventions.|||h||Full Range|Median
1313812|NCT02469961|Secondary|Total Narcotic Used by Each Participant|the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr||||Microgram||Standard Deviation|Mean
1313813|NCT02469961|Secondary|Number of Participants That Have Either Bradycardia or Hypotension|Number of participants observed with Bradycardia or Hypotension who required intervention|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|Number of patients who had Bradycardia or hypotension|||participants|||Number
1313814|NCT02469961|Secondary|Post Anesthesia Care Unit (PACU) Length of Stay|length of stay in minutes in the Post Anesthesia Care Unit before discharge|Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation||||Minutes||Standard Deviation|Mean
1313815|NCT02469961|Primary|Number of Participants That Need an Airway Intervention.|airway manipulation or repositioning: apnea, oral airway, adjust head|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr||||participants|||Number
1313816|NCT02469701|Primary|Response Rate of the Combination of Ablation and the PD-1 Inhibitor Nivolumab for Patients With Non-small Cell Lung Cancer (NSCLC) Who Have Progressed Following at Least 1 Prior Chemotherapy Regimen for Metastatic or Locally Advanced Disease.|Assessment of tumor response by scan 12 weeks post the first dose of Nivolumab and approximately every 12 weeks after. Post progression by RECIST a 1 month confirmatory scan will be done and that will be the indicator of Progression.|Up to 5 years.|Number of patients that were not known to Progress|||Participants|||Count of Participants
1313817|NCT02469597|Secondary|Length of Hospital Stay||Participants will be followed for the duration of hospital stay up to 1 week||||Days||Standard Error|Least Squares Mean
1313818|NCT02469597|Secondary|Patient Needing Endotracheal Intubation||Within 72 hours of medication administration||||participants|||Number
1313819|NCT02469597|Primary|Oxygen Saturation||4 hours after medication adminstration||||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
1313820|NCT02469597|Primary|Oxygen Saturation||2 hours after medication adminstration||||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
1313821|NCT02469597|Primary|Respiratory Rate||4 hours after medication adminstration||||Percentage change in respiratory rate||Standard Error|Least Squares Mean
1313822|NCT02469597|Primary|Respiratory Rate||2 hours after medication adminstration||||Percentage change in respiratory rate||Standard Error|Least Squares Mean
1313823|NCT02469415|Primary|Overall Response Rate (ORR)|The primary efficacy outcome of both parts is the overall response rate (ORR) based mainly on hematologic improvement defined by (International Working Group) IWG-2006 criteria, and which also includes complete remission (CR), partial remission (PR) and marrow complete remission.|28 days|Two participants were taken off study when the investigational agent was placed on full clinical hold by the Food and Drug Administration (FDA). The two participants who received the study medication were not on study long enough to make a formal response assessment.||||||
1313941|NCT02465866|Primary|Time to Reach Maximum Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||hours||Standard Deviation|Mean
1313824|NCT02469298|Secondary|Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14|Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 14|IPP Population. Only those participants (number with nasopharyngeal samples) available at the specified time points were analyzed.|||Participants|||Count of Participants
1313825|NCT02469298|Secondary|Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14|Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14|IPP population. Only those participants available at the specified time points were analyzed.|||Log median tissue culture infective dose||Standard Deviation|Mean
1313826|NCT02469298|Secondary|Total Dose of Relief Medication|Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.|Up to Day 28/withdrawal|Safety population. Only those participants using relief medication were analyzed.|||Milligrams||Full Range|Median
1313827|NCT02469298|Secondary|Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14|Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 14|IPP Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1313828|NCT02469298|Secondary|Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14|Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14|IPP population. Only those participants available at the specified time points were analyzed.|||Log viral particles/mL||Standard Deviation|Mean
1313829|NCT02469298|Secondary|Number of Hospital Admissions Due to Influenza Infection|Number of participants admitted in hospital due to influenza infection was recorded.|Up to Day 28/withdrawal|Safety population|||Participants|||Number
1313830|NCT02469298|Secondary|Number of Participants Who Used Relief Medication|Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.|Up to Day 28/withdrawal|Safety population.|||Participants|||Count of Participants
1313831|NCT02469298|Secondary|Number of Afebrile Participants Over Time Post Initiation of Treatment|Afebrile participants were defined as participants with oral temperature <=37.2 degree Celsius, <=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.|Up to Day 28/withdrawal|IPP population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1313832|NCT02469298|Secondary|Time to Resolution of Fever Over Time Post Initiation of Treatment|Time to resolution of fever was defined as the time when oral temperature was <= 37.2 degree Celsius (<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.|Up to Day 28/withdrawal|Influenza positive population (IPP) comprised of all randomized participants who received at least one dose of IP with proven influenza infection (positive rapid antigen test and positive influenza by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) or culture test at any time point). Participants with fever are analyzed.|||Hours||Full Range|Median
1313833|NCT02469298|Primary|Number of Participants With DRE of Interest-associated Antibiotic Use|Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
1313834|NCT02469298|Primary|Number of Participants With Disease Related Events (DREs) of Interest|Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
1313835|NCT02469298|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters|12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette’s formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
1313878|NCT02468830|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron|Cardiovascular safety: mean difference in heart rate (variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
1313836|NCT02469298|Primary|Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)|Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Percentage (%)||Standard Deviation|Mean
1313837|NCT02469298|Primary|Change From Baseline in Vital Signs- Temperature|Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Centigrade||Standard Deviation|Mean
1313838|NCT02469298|Primary|Change From Baseline in Vital Signs- Respiration Rate (RR)|Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
1313839|NCT02469298|Primary|Change From Baseline in Vital Signs- Heart Rate (HR)|Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1313840|NCT02469298|Primary|Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1313841|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
1313842|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
1313843|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population.|||Participants|||Count of Participants
1313844|NCT02469298|Primary|Change From Baseline in Urinalysis Parameters- Urine Specific Gravity|Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1), Day 5 and Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1313845|NCT02469298|Primary|Change From Baseline in Urinalysis Parameters- Urine pH|Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1), Day 5 and Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Points on a scale||Standard Deviation|Mean
1313846|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter (MMOL/L)||Standard Deviation|Mean
1313847|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Micromole per Liter (UMOL/L)||Standard Deviation|Mean
1313848|NCT02469298|Primary|Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)|Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||International Units per litre (IU/L)||Standard Deviation|Mean
1313849|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein|Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Grams per Litre (G/L)||Standard Deviation|Mean
1313850|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count|Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Trillion cells per Liter (TI/L)||Standard Deviation|Mean
1313851|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)|Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
1313852|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)|Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Picogram (PG)||Standard Deviation|Mean
1313853|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Hematocrit|Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
1313854|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Hemoglobin|Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Grams per Litre (G/L)||Standard Deviation|Mean
1313855|NCT02469298|Primary|Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count|Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Giga cells per litre (GI/L)||Standard Deviation|Mean
1313856|NCT02469298|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to Day 28/withdrawal|Safety population comprised of all randomized participants who received at least one dose of investigational product (IP).|||Participants|||Count of Participants
1313857|NCT02469246|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 96||Baseline to Week 96||2019-11-30|11/2019||||
1313858|NCT02469246|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 96||Baseline to Week 96||2019-11-30|11/2019||||
1313859|NCT02469246|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96||2019-11-30|11/2019||||
1313860|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at week 96 will be analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96||2019-11-30|11/2019||||
1313861|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at week 96 will be analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96||2019-11-30|11/2019||||
1314007|NCT02462291|Secondary|Blood Cholesterol LDL (mg/dl)|A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment||||(mg/dl)||Standard Deviation|Mean
1313862|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 96 will be analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96||2019-11-30|11/2019||||
1313863|NCT02469246|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline to Week 48|Spine DXA Analysis Set: all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline spine BMD values. Participants in the spine DXA Analysis Set with available data were analyzed.|||percent||Standard Deviation|Mean
1313864|NCT02469246|Secondary|Percent Change From Baseline in Hip BMD at Week 48||Baseline to Week 48|Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set: all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline hip BMD values. Participants in the Hip DXA Analysis Set with available data were analyzed.|||percent||Standard Deviation|Mean
1313865|NCT02469246|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1313866|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1313867|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1313868|NCT02469246|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all randomized participants who received at least one dose of study drug on or before 23 May 2016.|||percentage of participants|||Number
1313869|NCT02469168|Secondary|Number of Participants With Confirmed Treatment Area Closure|Complete wound closure is defined as skin wound re-epithelialization at 95% or greater at treated wound site and donor sites confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.|Prior to or at 6 weeks|did not enroll any additional participants|||Participants|||Count of Participants
1313870|NCT02469168|Primary|Number of Participants With Adverse Event|Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study|Prior to or at 12 weeks|did not enroll any additional participants|||Participants|||Count of Participants
1313871|NCT02469116|Other Pre-specified|Adverse Events as Measured by Number of Events Experienced by All Participants||30 days after completion of treatment (approximately 22 weeks)||||events|||Number
1313872|NCT02469116|Secondary|Quality of Life (QoL) as Measured by FACT-O Assessment Tool|"The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section~Answers range from Not at all to Very Much with 0 = not at all and 4 = very much"|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
1313873|NCT02469116|Secondary|Progression-free Survival (PFS)|-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
1313874|NCT02469116|Secondary|Overall Survival (OS)|Overall Survival is the observed length of life from entry into the study to death or the date of last contact|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
1313875|NCT02469116|Secondary|Time to Progression (TTP)|Progressive disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Unequivocal progression of existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, in the opinion of the treating physician within 8 weeks of study entry is also considered increasing disease (in this circumstance an explanation must be provided). In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in the LD is required.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
1313876|NCT02469116|Secondary|Efficacy of Regimen as Measured by CA-125 Response|"Progression is defined as one of the following:~Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 ≥ twice the upper limit of normal on two occasions at least one week apart~Patients with elevated CA-125 pretreatment which never normalizes must show evidence of CA-125 ≥ 2 times the nadir value OR > 50% increase from the nadir on two occasions at least one week apart,~Patients with CA-125 in the normal range pretreatment must show evidence of CA-125 ≥ two times the upper limit of normal on two occasions at least one week apart.~Complete response is defined as a CA-125 value <13 confirmed on two occasions at least 2 weeks apart.~Partial Response is defined as a reduction of at least 50% from the original elevated CA-125 value (original value must have been > 50), confirmed on two occasions at least 2 weeks apart.~Stable Disease is defined as not meeting one of the above criteria."|Completion of treatment (approximately 18 weeks)||||participants|||Number
1313879|NCT02468830|Secondary|Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale|"The Patient Perception of Bladder Condition (PPBC) scale on a 6-point score scale at baseline and final visit.~Explanation of possible answer:~does not cause me any problems at all,~causes me some very minor problems,~causes me some minor problems,~causes me (some) moderate problems,~causes me severe problems,~causes me many severe problems"|Participants will be followed for the duration of the study, up to 52 weeks||||units on a scale||Inter-Quartile Range|Median
1313880|NCT02468830|Secondary|Number of Participants With Cardio Vascular Safety|"Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg).~Parameters to be measure at each visit but particularly at visit 2 (Week 0, first dose on site), to be obtained before and 1 hour after taking the medication)."|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
1313881|NCT02468830|Primary|Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron|Change in mean bladder capacity from baseline to final visit based on voiding diary.|Participants will be followed for duration of the study, up to 52 weeks||||milliliter||Inter-Quartile Range|Median
1313882|NCT02468830|Primary|Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron|Percent change in the frequency of urinary incontinence episodes as a Measure of Efficacy.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
1313883|NCT02468700|Primary|Total Conjunctival Lissamine Green Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)|Day 30||||units on a scale||Standard Deviation|Mean
1313884|NCT02468700|Primary|Total Conjunctival Lissamine Green Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)|Day 15||||units on a scale||Standard Deviation|Mean
1313885|NCT02468700|Primary|Total Corneal Fluorescein Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)|Day 30||||units on a scale||Standard Deviation|Mean
1313886|NCT02468700|Primary|Total Corneal Fluorescein Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)|Day 15||||units on a scale||Standard Deviation|Mean
1313887|NCT02468583|Secondary|Average Weekly and Total Consumption of Rescue Medication||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313888|NCT02468583|Secondary|Time to Onset of Pain Relief|Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline|Baseline to >30% improvement|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313889|NCT02468583|Secondary|Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313890|NCT02468583|Secondary|Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313891|NCT02468583|Secondary|Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313892|NCT02468583|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313893|NCT02468583|Secondary|WOMAC (Total):|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313894|NCT02468583|Secondary|WOMAC C (Function)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313895|NCT02468583|Secondary|WOMAC B (Stiffness)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313896|NCT02468583|Secondary|WOMAC A1 (Pain on Walking Question)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313897|NCT02468583|Secondary|WOMAC A (Pain Subscale)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313898|NCT02468583|Secondary|Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week||12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313899|NCT02468583|Secondary|Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week||12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313900|NCT02468583|Secondary|Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week||12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313918|NCT02467075|Secondary|Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)|Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.|30 days||||Participants|||Count of Participants
1313901|NCT02468583|Secondary|Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313902|NCT02468583|Primary|Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|5-10 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
1313903|NCT02468414|Primary|Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum EPO Levels Above Baseline.||52 weeks|No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.|||Participants|||Count of Participants
1313904|NCT02468154|Secondary|Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10|The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived|one time at cast removal (expected average of 30 days).||||units on a scale||Standard Deviation|Mean
1313905|NCT02468154|Secondary|Health Staff/Caregiver Interventions|daily number of interventions by health staff /caregiver to maintain the cast in an off-loaded position, marked on a form given daily to the family/caregiver|up to the first 2 days during hospitalization||||daily number of interventions||Standard Deviation|Mean
1313906|NCT02468154|Secondary|Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel –N.P.U.A.P.||one time at cast removal (expected average of 30 days).||||participants|||Number
1313907|NCT02468154|Primary|"Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group"|All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain|up to the first 2 days during hospitalization and at cast removal (maximum 30 days).||||units on a scale||Standard Deviation|Mean
1313908|NCT02467777|Primary|Temperature|Measured by temporal artery thermometer|Intra-Operative||||degrees celsius||Standard Deviation|Mean
1313909|NCT02467491|Secondary|Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in 4 weeks to 3 months||||units on a scale||Standard Deviation|Mean
1313910|NCT02467491|Secondary|Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in baseline to 4 weeks||||units on a scale||Standard Deviation|Mean
1313911|NCT02467491|Primary|Global Appreciation Score|"The global appreciation score is a measure of feasibility.~This score will be derived from each participant's answer to the first question of a 9-item acceptability questionnaire. The second question of the questionnaire is :How much did you like Jintronix?, participants' answer may be:~I didn't like it (0 point)~A little (1 points)~Moderate (2 points)~A lot (3 points). The global appreciation score is the sum of the points obtained by each participants.~The global appreciation score for 12 participants may range from 0 (no appreciation) to 36 (a lot of appreciation).~In order to say that Jintronix is feasible we expected a global appreciation score for 12 participant after 4 weeks of intervention to be > 24."|4 weeks||||units on a scale|||Number
1313912|NCT02467491|Primary|Global Difficulty Score|"The global difficulty score was another measure of acceptability.~The global difficulty score will be derived from each participant's answer to the second question of a 9-item feasibility questionnaire. The second question of the questionnaire is :How difficult did you find the Jintronix?, participants' answer may be:~Very difficult (3 point)~Quite difficult (2 points)~Not at all (1 points)~No difficulty (0 points). This means that the global difficulty score for 12 participants may range from 0 (no difficult) to 36 (very difficult).~We expected to find a global difficulty score < to 15 in order to say that Jintronix was acceptable."|4 weeks||||units on a scale|||Number
1313913|NCT02467491|Primary|Total Average Time in Performing Exercises With Jintronix.|"Each participant has to perform the exercise program with Jintronix for 30 minutes per session, for 2 times/week for a total of 4 weeks.~This means that each participant has to be able to perform a maximum of 240 minutes of exercises for 4 weeks.~Jintronix calculated automatically the time (minutes) in performing the exercises for each participant at the end of the 4 weeks of intervention.~As a measure of acceptability we calculated the total average time in performing the exercises for the 12 participants for 4 weeks by summing the minutes in performing the exercises for each participants for 4 week and dividing it for 12.~We expected to find an average total time in performing the exercises for 12 participants > 192 minutes (3.2 hours) out of a total of 240 minutes (4 hours) in order to say that Jintronix was acceptable."|4 weeks||||minutes||Standard Deviation|Mean
1313914|NCT02467491|Primary|Quality of Movements' Total Average Score|"The quality of movements’ score is a measure of feasibility. The quality of movement's score is automatically calculated by Jintronix for each participant at the end of the intervention program with Jintronix.~A quality of movement's score of 100% means that the participant performed the exercise perfectly.~To calculate the quality of movements' total average score for the Group (made of 12 participants), we summed the quality of movements' score for each participants and divided it for 12. We expected to find a total average quality movements' score>80% in order to say that Jintronix was feasible."|4 weeks||||percentage of quality of movements||Standard Deviation|Mean
1313915|NCT02467075|Secondary|Mortality Rate - 30 Day|Number of subjects who died within 30 days of entry into the study.|30 days||||participants|||Number
1313916|NCT02467075|Secondary|30-day Readmission|Number of times a subject is readmitted within 30 days of study recruitment|30 days||||Number of admissions||Standard Deviation|Mean
1313917|NCT02467075|Secondary|Hospital Length of Stay|Subject's hospital length of stay in days|Duration of hospital stay (assessed from date of randomization up to 30 days)||||days|days|Standard Deviation|Mean
1313920|NCT02467075|Primary|Participants With Stage II AKI (Acute Kidney Injury)|Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.|48 hours|Participants with State II AKI (Acute Kidney Injury)|||Participants|||Count of Participants
1313921|NCT02466659|Other Pre-specified|Amblyopia|It is defined when visual acuity between two eyes equal or over 2 logMAR lines.|3 Months||||Participants|||Count of Participants
1313922|NCT02466659|Primary|Change in Composite Measure of IXT Control Score|"IXT control score: referring to the Pediatric eye disease investigator group (PEDIG).~PEDIG scale of control for IXT 1-5 is defined as the following:~5 = Constant exotropia 4 = exotropia > 50% of the 30-sec period before dissociation 3 = exotropia < 50% of the 30-sec period before dissociation 2 = No exotropia unless dissociated, recovers in > 5 sec~1 = No exotropia unless dissociated, recovers in 1-5 sec 0 = No exotropia unless dissociated, recovers in < 1 sec (phoria) Not Applicable = No exotropia present"|12 weeks; 24 weeks||||units on a scale||Standard Deviation|Mean
1313923|NCT02466425|Secondary|Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4)|CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Visit 6 (Week 4)|FAS with number of participants evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
1313924|NCT02466425|Primary|Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4)|The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms.|Baseline, Visit 6 (Week 4)|Full-analysis set (FAS) consisted of the safety set who had at least 1 post-dose ADHD-RS-IV total score assessment. FAS with number of participants evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
1313925|NCT02466412|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.|"The PK population consisted of 47 subjects.~1 subject was excluded from the PK population (sequence CHTP 1.1 M then mCC) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC."|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1313926|NCT02466412|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares (LS) means are provided."|Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.|"The PK population consisted of 47 subjects.~1 subject was excluded from the PK population (sequence CHTP 1.1 M then mCC) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC."|||ng/mL||95% Confidence Interval|Least Squares Mean
1313927|NCT02465866|Primary|Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation|"Calculated as:~AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100"|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||Percentage of AUCExtrap||Standard Deviation|Mean
1313928|NCT02465866|Primary|Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity|"Calculated as:~AUCinf = AUClast + Clast/λz"|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313929|NCT02465866|Primary|Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration|Calculated using the linear trapezoidal rule|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313930|NCT02465866|Primary|AUC0-4.0 for Hydrocodone and Promethazine|AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 4 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313931|NCT02465866|Primary|AUC0-2.0 for Hydrocodone and Promethazine|AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 2 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313932|NCT02465866|Primary|AUC0-1.5 for Hydrocodone and Promethazine|AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 1.5 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313933|NCT02465866|Primary|AUC0-1.0 for Hydrocodone and Promethazine|AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 1.0 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313934|NCT02465866|Primary|AUC0-0.75 for Hydrocodone and Promethazine|AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.|0 (Pre-dose) to 0.75 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313935|NCT02465866|Primary|AUC0-0.50 for Hydrocodone and Promethazine|AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 0.5 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313936|NCT02465866|Primary|Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine|AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 0.25 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
1313937|NCT02465866|Primary|Observed Terminal Elimination Half-life (T1/2)|Calculated as: T1/2 = ln(2)/λz|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||hours||Standard Deviation|Mean
1313938|NCT02465866|Primary|Observed Elimination Rate Constant (λz)|Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||h-1||Standard Deviation|Mean
1313942|NCT02465866|Primary|Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data|Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|Intended to treat (ITT) population|||ng/mL||Standard Deviation|Mean
1313943|NCT02465632|Primary|Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)|The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.|Baseline and 10 Weeks||||Percentage change from baseline||Standard Deviation|Mean
1313944|NCT02465632|Primary|Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)|The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.|Baseline and 10 Weeks||||percentage change from baseline||Standard Deviation|Mean
1313945|NCT02465489|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 36 or early termination)|The safety population included all subjects who received at least one of the investigational products under study|||participants|||Number
1313946|NCT02465489|Primary|AUC0-∞for Serum Deferiprone|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose.|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods|||ug*h/mL||Standard Deviation|Mean
1313947|NCT02465489|Primary|Tmax for Serum Deferiprone|Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods|||Hour||Standard Deviation|Mean
1313948|NCT02465489|Primary|Cmax for Serum Deferiprone|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods.|||μg/mL||Standard Deviation|Mean
1313949|NCT02465463|Secondary|Mean Cost of Treatment|Total cost was calculated as a summation of costs of medications, procedures, and fecal transplant used to treat C.difficile for each individual patient. A mean was calculated for both groups.|Post-Intervention (Month 6)|Participants that have completed the study.|||dollars||Standard Deviation|Mean
1313950|NCT02465463|Secondary|Mean Hospital Anxiety And Depression Scale (HADS) Score|The HADS is a fourteen item scale and each item on the questionnaire is scored from 0-3, from 0 = best and 3 = worst. A score can range between 0 and 21 for either anxiety or depression. Higher scores represent greater depressive/anxious symptoms.|Post-Intervention (Week 12)|No difference in anxiety and depression scores were seen between the two populations at baseline and at 12 weeks.|||units on a scale||Standard Deviation|Mean
1313951|NCT02465463|Secondary|Mean Short Form - 36 (SF-36) Score|SF-36: consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Post-Intervention (Week 12)|Participants that have completed the study.|||units on a scale||Standard Deviation|Mean
1313952|NCT02465463|Primary|Change in the Shannon Diversity Index|The Shannon Diversity Index is a quantitative measure that reflects how many different types (such as species) there are in a dataset (a community). 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota were analyzed for both groups using the Shannon Diversity index (H). The greater the index, the more diverse a species.|Baseline, Post-Intervention (Week 12)|Participants that completed the study.|||H|||Number
1313953|NCT02465463|Primary|Number of Participants That Experience Serious Adverse Events|"A serious adverse event is any adverse experience that results in any of the following outcomes:~Death;~Life-threatening experience (adverse event is considered “life-threatening” if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death);~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability or incapacity;~Is a congenital anomaly or birth defect;~Is considered to be an important medical event (that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed in the definition above)."|Post-Intervention (Month 6)|Participants that completed the study.|||Participants|||Count of Participants
1313954|NCT02465463|Primary|Clinical Remission Rates|Clinical remission rate is defined as the number of participants with an absence of clinical symptoms and/or negative C.difficile stool PCR.|Post-Intervention (Week 12)|Participants that completed the study.|||Participants|||Count of Participants
1313955|NCT02465450|Secondary|JBT-101 (Lenabasum) Plasma Concentrations on Day 84|Plasma concentrations were reported for the lenabasum 20 mg QD, 20 mg BID, and placebo groups only, at Day 84.|Day 84||||ng/mL||Standard Deviation|Mean
1313956|NCT02465450|Primary|Number of Participants With Treatment Emergent Adverse Events.||84 days of treatment|These adverse events are based on subjects who entered Treatment Period 2 (n=81). The tabulation of adverse events includes all TEAEs.|||Participants|||Count of Participants
1313957|NCT02465203|Secondary|Safety Parameters|Safety over time of previous alisporivir exposure|27 months|"There was no hypothesis testing as the study was prematurely terminated. AE and SAE data are provided in the Adverse Events section~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected"||||||
1314008|NCT02462291|Secondary|Blood Cholesterol HDL (mg/dl)|A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment||||(mg/dl)||Standard Deviation|Mean
1313958|NCT02465203|Secondary|Safety Parameters as Measured by Liver UltraSound and Lab Parameters|Development of hepatocellular carcinoma (HCC)|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~No data for any pre-specified Outcomes were analyzed.~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected"||||||
1313959|NCT02465203|Secondary|Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters|Changes in liver function and disease over time|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~No data for any pre-specified Outcomes were analyzed.~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected"||||||
1313960|NCT02465203|Secondary|Safety Parameters as Measured by HCV RNA Sequencing|Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for efficacy of 650 participants, and only 105 were randomized~No data are available because data were not collected"||||||
1313961|NCT02465203|Primary|HCV RNA Sequencing|Persistence of resistance associated variants|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~4 patients with resistance associated variants have been identified at study start. Study was not powered for 105 participants"|||Number of particiants|||Number
1313962|NCT02465099|Primary|Estimated Intraoperative Blood Loss|Estimated blood loss during intraoperative Stage 1, defined as the period from first incision to the first bone violation/cut (e.g., first pedicle screw drill); and intraoperative Stage 2, defined as the period from first bone violation/cut to last suture.|Intraoperative|All subjects in which the procedure was started. There was one subject that was enrolled who was to receive treatment with ultrasonic dissection, but the procedure was not performed due to study closure. Therefore, N=19 subjects enrolled for the ultrasonic dissection group, but only 18 subjects received treatment.|||milliliters||Standard Deviation|Mean
1313963|NCT02465073|Primary|The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care||Percentage after 4 weeks||||percentage of participants|||Number
1313964|NCT02464176|Secondary|Verbal Numeric Pain Score Comparisons|This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better.|24 hour||||scores on a scale||Inter-Quartile Range|Median
1313965|NCT02464176|Secondary|Total Opioid Consumption||30 hours||||oxycodone mg equivalents||Inter-Quartile Range|Median
1313966|NCT02464176|Secondary|Time to First Analgesic Request|Time (in minutes) will be recorded to first analgesic request following the block placement|30 hours||||minutes||Inter-Quartile Range|Median
1313967|NCT02464176|Primary|Duration of Sensory Blockade|The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation.|30 hours||||hours||Standard Deviation|Mean
1313968|NCT02464163|Secondary|Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine|Unsolicited adverse events (UAEs) Days 0-42.|42 Days|Safety Population|||Participants|||Count of Participants
1313969|NCT02464163|Secondary|Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination||13 months|Safety Population|||Participants|||Count of Participants
1313970|NCT02464163|Secondary|Reactogenicity Immediately After Each Injection, Extending to Day 7|Solicited events of local and systemic reactogenicity Days 0-7|7 Days|Reactogenicity Population|||Participants|||Count of Participants
1313971|NCT02464163|Primary|Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.|The primary endpoint will be “seroprotection rate” to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults <65 and ≥60% for adults ≥65 years of age.|42 Days|Modified Per Protocol Population|||Participants|||Count of Participants
1313972|NCT02463981|Primary|Pain Empathy Rating Scores|Subjects were required to rate their empathic feeling towards painful pictures on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very painful). The effects of training on the empathy for pain were analyzed comparing the feedback group with the controls group. For each subject differences were calculated between pictures that were preceded by a training compared to a no-training block. Within the context of the present design we expected that training-induced increases in anterior insula activity should lead to higher pain empathy ratings in the training group as compared to the control group.|three days.|From the initial population of 37 participants 5 had to be excluded because of high head movement during fMRI acquisition. This is a standard procedure in fMRI studies given that the analysis is very susceptible to movement artifacts.|||units on a scale||Standard Error|Mean
1313973|NCT02463981|Primary|Neural Activity of Anterior Insula During Neorofeedback Training|Neural activity was analyzed using standard fMRI analysis procedure that examine neural activity during training of anterior insula regulation. The measures include BOLD signal analysis (reflecting neural activity strengths) as well as functional connectivity analysis (that examine the interaction between different brain regions).|three days.|From the initial population of 37 participants 5 had to be excluded because of high head movement during fMRI acquisition. This is a standard procedure in fMRI studies given that the analysis is very susceptible to movement artifacts.|||percentage of BOLD signal change||Standard Error|Mean
1313974|NCT02463409|Secondary|Change in Apnea Hypopnea Index (AHI)|Change in AHI before and during treatment with theophylline|1 day||||units on a scale||Standard Error|Mean
1313975|NCT02463409|Secondary|Change in Resting Energy Expenditure (REE)|Change in REE before and during treatment with theophylline|1 day||||kcals per day||Standard Error|Mean
1313976|NCT02463409|Primary|Change in Urine cAMP|Change in urine cAMP (after parathyroid hormone stimulation) before and during treatment with theophylline|1 day|Patients treated with theophylline who maintained appropriate IV access. Only 3 patients had complete data available.|||fm/uL||Standard Deviation|Mean
1313977|NCT02463331|Secondary|Histopathological Response to Therapy|Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.|liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response|The histological response was only evaluated in the patients with biochemical remission, since in the patients without biochemical response it was already known that there would be activity in the liver tissue.|||Participants|||Count of Participants
1313978|NCT02463331|Primary|Biochemical Response to Therapy|The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.|six months||||Participants|||Count of Participants
1313979|NCT02463227|Secondary|Percentage of Participants Who Had a Confirmed HIV-1 RNA Greater Than or Equal to 200 Copies/mL at Week 4 of the ATI or Indication to Reinitiate ART Prior to Week 4 of the ATI|The secondary efficacy outcome was the percentage of participants who had a confirmed HIV-1 RNA greater than or equal to 200 copies/mL at week 4 of the ATI or indication to reinitiate ART prior to week 4 of the ATI.|Measured at weeks 1, 2, 3, and 4 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||percentage of participants||90% Confidence Interval|Number
1313980|NCT02463227|Secondary|Measured Values of VRC01 in Plasma in the First 8 Weeks of the Analytical Treatment Interruption (ATI)|Measured values of plasma VRC01, measured in micrograms per milliliter, through week 8 of the ATI. The median and range of all VRC01 measurements taken in the first 8 weeks of the ATI were reported.|Measured at weeks 1, 2, 3, 4, 5, 6, 7, and 8 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||micrograms/mL||Full Range|Median
1313981|NCT02463227|Secondary|Measured Value of Plasma VRC01 at the Time of Rebound|Measured value of plasma VRC01, measured in micrograms per milliliter, at the time of rebound. Rebound is defined as the point in time when plasma HIV-1 RNA surpassed 40 copies/mL.|Measured from entry through week 21 (Steps 1 and 2)|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||micrograms/mL||Full Range|Median
1313982|NCT02463227|Primary|Percentage of Participants Who Had a Confirmed HIV-1 RNA Greater Than or Equal to 200 Copies/mL at Week 8 of the Analytical Treatment Interruption (ATI) or Indication to Re-initiate ART Prior to Week 8 of the ATI|The primary efficacy outcome is the percentage of participants who had a confirmed HIV-1 RNA greater than or equal to 200 copies/mL at week 8 of the analytical treatment interruption (ATI) or indication to re-initiate ART prior to week 8 of the ATI.|Measured at Weeks 1, 2, 3, 4, 5, 6, 7, and 8 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||percentage of participants||90% Confidence Interval|Number
1313983|NCT02463227|Primary|Percentage of Participants Who Experienced a Grade 3 or Higher Systemic (i.e., Not a Local Reaction) Adverse Event (AE) That is Possibly, Probably, or Definitely Related to the Administration of the VRC01 Antibody|The primary safety outcome examined the occurrence of a Grade 3 or higher systemic (i.e., not a local reaction) adverse event (AE) possibly, probably, or definitely related to the administration of the VRC01 antibody. The DAIDS AE Grading Table (V2.0) was used.|Measured from entry through week 21 (Steps 1 and 2)|All participants exposed to study treatment (VRC01) were included.|||percentage of participants||95% Confidence Interval|Number
1313984|NCT02463097|Secondary|Number of Diabetic Ketoacidosis (DKA) Events|There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.|3 months||||events|||Number
1313985|NCT02463097|Secondary|Number of Severe Hypoglycemia Events|There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.|3 months||||events|||Number
1313986|NCT02463097|Primary|Change in A1C|There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.|Baseline and 3 months||||Percent||Standard Deviation|Mean
1313987|NCT02462720|Secondary|Patient Preference|Patient preference for RFA or Varithena® using e-diary|8 weeks||||Participants|||Count of Participants
1313988|NCT02462720|Secondary|Procedural Pain|degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine|immediately following procedure||||units on a scale||Standard Error|Mean
1313989|NCT02462720|Primary|Pain|14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.|14 day average (0-100)||||units on a scale||Standard Error|Mean
1313990|NCT02462473|Secondary|Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12|The PSS is a brief scale designed to capture a psychiatric patient’s satisfaction with a clinician. The scale covers 6 domains: Trust (3 items), Communication (3 items), Exploration of Ideas/Options (2 items), Body Language (2 items), Active Listening (4 items), and Miscellaneous Items (6 items). Out of the 20 items, the first 19 are scored on a 5-point Likert Scale (1=strongly disagree, 2=disagree, 3=satisfactory, 4=agree, 5=strongly agree). The last question (6f) is a free-response question asking for input on how the clinician might improve. Sum of scores of individual items give a total score (range 9-95). Higher scores indicate greater degree of satisfaction. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
1314009|NCT02462291|Secondary|Blood Glucose (mg/dl)|A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.|PRE and POST 6 months of treatment||||(mg/dl)||Standard Deviation|Mean
1314010|NCT02462291|Secondary|Diastolic Blood Pressure (mmHg)|Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment||||(mmHg)||Standard Deviation|Mean
1314011|NCT02462291|Secondary|Systolic Blood Pressure (mmHg)|Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment||||(mmHg)||Standard Deviation|Mean
1313991|NCT02462473|Secondary|Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12|The BARS is a 4-item scale that includes 3 questions and an overall visual analog rating scale that assesses participant’s knowledge about his/her medication. The key measure of adherence is the visual analog scale and assesses the percentage of doses taken by the participants in the past month (0 percent [%] - 100%). The 3 questions include: number of prescribed doses per day, number of days in the past month when the participant did not take the prescribed doses, and the number of days in the past month when the participant took less than the prescribed dose. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||percent adherence|||Number
1313992|NCT02462473|Secondary|Clinician’s Rating Scale of Adherence (CRS) Score at Week 0 and 12|The CRS is an ordinal scale filled by the clinician. The scores range from 1 to 7 that were used to quantify the clinician’s assessment of treatment adherence by the patient. Higher scores indicate greater adherence. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
1313993|NCT02462473|Secondary|Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)|The CASP and data on concomitant medications and psychosocial treatments were used to evaluate the impact of AMPL results on other aspects of clinical decision making.|Up to Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||participants|||Number
1313994|NCT02462473|Secondary|Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12|AMPL of the individual participant during the active assessment phase was reported.|Week 12|AMPL analysis set included all enrolled participants who had AMPL data for at least 1 visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||nanogram per milliliter|||Number
1313995|NCT02462473|Secondary|Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12|The DPSS is a clinician-rated scale used to rate 8 domains commonly seen in patients with psychotic disorders. Each domain was rated on a 5-point scale (0 to 4) with anchored description of endpoints. Total score was computed by summing the scores of individual items (range of 0–32). Higher scores represent more severe condition. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
1313996|NCT02462473|Secondary|Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12|Clinical Global Impression-Severity (CGI-S) rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
1313997|NCT02462473|Primary|Number of Participants With Medication Treatment Modifications (MTM)|Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making.|Up to Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||Participants|||Number
1313998|NCT02462291|Secondary|Number of Patients Treated With Ticlopidin||PRE and POST 6 months of treatment||||Participants|||Number
1313999|NCT02462291|Secondary|Number of Patients Treated With Memantine||PRE and POST 6 months of treatment||||Participants|||Number
1314000|NCT02462291|Secondary|Number of Patients Treated With Donepezil||PRE and POST 6 months of treatment||||Participants|||Number
1314001|NCT02462291|Secondary|Number of Patients Treated With Citalopram||PRE and POST 6 months of treatment||||Participants|||Number
1314002|NCT02462291|Secondary|Number of Patients Treated With Quetiapine||PRE and POST 6 months of treatment||||Participants|||Number
1314003|NCT02462291|Secondary|Number of Medications||PRE and POST 6 months of treatment||||Number of Medications||Standard Deviation|Mean
1314004|NCT02462291|Secondary|Salivary Cortisol (Nmol/l)|Levels of cortisol was measured via saliva samples using plain Sarstedt Salivette collection devices (Nümbrecht, Germany). Samples will be collected at 6.30 AM, 11.30 AM, and 6.30 PM. Immediately after collecting the saliva samples, were centrifuged for 2 min at 1,000 rpm. Purified saliva was stored in a freezer at -20 °C, and subsequently analyzed. Cortisol levels was determined by a time-resolved immunoassay with fluorometric detection.|PRE and POST 6 months of treatment||||(nmol/L)||Standard Deviation|Mean
1314005|NCT02462291|Secondary|Evaluation of Activity of Daily Life|Independence and level of activities of daily life (ADL) were evaluated with the Barthel index. Levels of ADL was measured by observing each resident’s daily activities (eating, bathing, grooming, dressing, transfers from bed to chair, mobility on level planes, stairs, and getting on/off the toilet). The total score of the Barthel index is 0-100, and higher values represent a better outcome.|PRE and POST 6 months of treatment||||Scores on a scale||Standard Deviation|Mean
1314006|NCT02462291|Secondary|Daily Energy Expenditure (Kcal/Day)|Daily energy expenditure was measured with an Actiheart device (CamNtech, Cambridge, UK) allowing heart rate and acceleration data to be simultaneously recorded for 24 h/day for 7 consecutive days.|PRE and POST 6 months of treatment||||(Kcal/day)||Standard Deviation|Mean
1314012|NCT02462291|Secondary|Body Composition (Kilograms of Fat Free Mass)|Body mass and skin-fold measurements were measured three times a day by the same experienced operator. The average value of the three measurements was calculated. Kilograms of fat free mass was estimated using a validated equation.|PRE and POST 6 months of treatment||||kg||Standard Deviation|Mean
1314013|NCT02462291|Primary|Evaluation of Cognitive Status (Score 0-30)|Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome.|PRE and POST 6 months of treatment||||Scores on a scale||Standard Deviation|Mean
1314014|NCT02462291|Primary|Evaluations of Behavioral Disorders|Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome.|PRE and POST 6 months of treatment||||Scores on a scale||Standard Deviation|Mean
1314015|NCT02462148|Secondary|Time to First Opioid Analgesic Request|Time it took for the first opioid analgesic request was recorded.|0 to 36 hours||||minutes||Standard Deviation|Mean
1314016|NCT02462148|Secondary|Post Operative Opioid Use and Consumption|Amount of opioid use and consumption was recorded.|0-30 hours||||mg oxycodone equivalents||Standard Deviation|Mean
1314017|NCT02462148|Secondary|Neurologic Complications|Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.|throughout study completion, up to 48 hours||||neurological complications||Standard Deviation|Mean
1314018|NCT02462148|Secondary|Rate of Post Operative Nausea and Vomiting|Number of participants that experienced nausea and vomiting was recorded.|0 to 30 hours||||Participants|||Count of Participants
1314019|NCT02462148|Secondary|Verbal Pain Scores|Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.|0 to 30 hours||||units on a scale||Standard Deviation|Mean
1314020|NCT02462148|Primary|Duration of Sensory Nerve Block|The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.|12 to 48 hours||||hours||Standard Deviation|Mean
1314021|NCT02461992|Other Pre-specified|Number of Participants With Positive FVIII Inhibitor Activity at Day 4|As with all FVIII products, participants using Xyntha were monitored for the development of FVIII inhibitors. Values >= 0.6 Bethesda Unit (BU) per mL were considered positive results.|Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1314022|NCT02461992|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <50 beats per minute (bpm), >=30 bpm increase from baseline, or >25 bpm decrease from baseline; systolic blood pressure (SBP) <90 milliliters of mercury (mmHg), >=30 mmHg increase from baseline, or >=30 mmHg decrease from baseline; diastolic blood pressure (DBP) <50 mmHg, >=20 mmHg increase from baseline, or >=20 mmHg decrease from baseline.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1314023|NCT02461992|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, RBC morphology, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine drug screening, FVIII inhibitor assay, FVIII activity, prothrombin time [PT], activated partial thromboplastin time [APTT], anti-human immunodeficiency virus [HIV] 1, hepatitis C virus antibody [HCVAb], HAVAb, HBsAg, HBsAb, HBcAb). Only parameters which met abnormality criteria are reported.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1314024|NCT02461992|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 28|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1314025|NCT02461992|Primary|Incremental Recovery (INCREC)|Incremental recovery is the increase in circulating FVIII activity for every IU of Xyntha administered per kilogram of body weight.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU/deciliter (dL) per IU/kg||Geometric Coefficient of Variation|Geometric Mean
1314026|NCT02461992|Primary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||hour||Geometric Coefficient of Variation|Geometric Mean
1317275|NCT02368314|Secondary|Frequency of Distal DVT|Frequency of distal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1314027|NCT02461992|Primary|Terminal Elimination Half-Life (t1/2)|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||hour||Standard Deviation|Mean
1314028|NCT02461992|Primary|Terminal Phase Rate Constant (Kel)|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural­-logarithm transformed concentration-­time profile.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
1314029|NCT02461992|Primary|Volume of Distribution at Steady-State (Vss)|Volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the volume of distribution at steady-state.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1314030|NCT02461992|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||mL/hour/kg||Geometric Coefficient of Variation|Geometric Mean
1314031|NCT02461992|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||hour||Full Range|Median
1314032|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1314033|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1314034|NCT02461992|Primary|Maximum Plasma FVIII Activity (Cmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1314035|NCT02461966|Primary|Serum Aflatoxin Level in Liver Cancer Patients|Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.|6 months||||ng\ml||Standard Deviation|Mean
1314036|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.|||seconds||Standard Error|Mean
1314037|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.|||counts||Standard Error|Mean
1314038|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.|||Proportion correct||Standard Error|Mean
1314911|NCT02434497|Secondary|Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline Non-HDL-C/HDL-C|participants|95% Confidence Interval|Geometric Mean
1314039|NCT02461693|Primary|Mood State Score on POMS-2 Test|"Profile of Mood States (POMS-2)- Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling “right now” on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable. - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score."|30 minutes post pill consumption|Results are of raw data as presented in our publication|||units on a scale||Standard Error|Mean
1314040|NCT02461589|Secondary|Change in Systolic and Diastolic Blood Pressure|"The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, Week 26|Full analysis set|||mmHg||Standard Deviation|Mean
1314041|NCT02461589|Secondary|Body Weight Change|"The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, Week 26|Full analysis set|||kg||Standard Deviation|Mean
1314042|NCT02461589|Secondary|Change in Fasting Plasma Glucose (FPG)|"Estimated mean change from baseline in FPG at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, Week 26|"Full analyses set. For Semaglutide flexible arm, data was available only for 63 subjects."|||mmol/L||Standard Deviation|Mean
1314043|NCT02461589|Primary|Change in HbA1c (Glycosylated Haemoglobin)|"Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, week 26|Full analysis set|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1314044|NCT02461550|Primary|The Frequency of Adverse Events|"Safety will be measured by using the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0). The goal of this study is to establish safety.~If there are 3 or more grade 3 or higher device related AEs, then we will stop the study."|2 years|Data were not collected||||||
1314045|NCT02461433|Secondary|General Health as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
1314046|NCT02461433|Secondary|Pain as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
1314047|NCT02461433|Secondary|Emotional Well Being as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
1314048|NCT02461433|Secondary|Energy / Fatigue as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
1314049|NCT02461433|Secondary|Social Functioning as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
1314050|NCT02461433|Secondary|Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
1314051|NCT02461433|Secondary|Readmissions|Readmission events for the patients.|Up to 30 days postop||||readmission events|||Number
1314052|NCT02461433|Secondary|Physical Function as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
1314053|NCT02461433|Secondary|Skin Bacterial Count as Assessed by Microbacterial Count|Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count|Up to 7 days postop|The samples were not sent to the lab||||||
1314054|NCT02461433|Secondary|Other Wound Complications (Aggregate)|Dehiscence, seroma and hematoma. Reported as number of aggregate events.|Up to 14 days postop||||aggregate wound complication events|||Number
1314055|NCT02461433|Primary|Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines|The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery|Up to 7 days postop||||Surgical Site infections|||Number
1314056|NCT02461290|Secondary|Percentage of Participants Alive at 1, 2, and 3 Years|Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as [number of participants alive divided by the number analyzed] multiplied by 100.|At 1, 2, and 3 years|ITT Population.|||percentage of participants|||Number
1317276|NCT02368314|Secondary|Frequency of Proximal DVT|Frequency of proximal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1314057|NCT02461290|Secondary|Percentage of Participants With CR According to International Working Group Response Criteria for NHL|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population.|||percentage of participants|||Number
1314058|NCT02461290|Secondary|Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population: All enrolled participants who provided complete and evaluable outcome data.|||percentage of participants|||Number
1314059|NCT02461290|Primary|Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE|The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.|Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|ITT Population.|||participants|||Number
1314060|NCT02461134|Other Pre-specified|Assessment of a Partial or Complete Overall Response at Week 24|The exploratory efficacy endpoint is based on the 2014 NIH Consensus Development Project response criteria. A complete overall response is defined as a resolution of all reversible manifestations due to chronic GVHD in each organ as defined per NIH Consensus Development Project response criteria. A partial overall response is defined as improvement in a measure for at least one organ without progression in measures for any other organ.|At Week 24|Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed. The statistical analysis plan issued is obsolete, it was not finalized and was therefore not executed.||||||
1314061|NCT02461134|Secondary|Incident Rate of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|This outcome measure reports the occurrence of adverse events (AEs), and serious adverse events (SAEs) during the treatment period and the follow-up period, and AEs leading to premature discontinuation of study drug. A treatment-emergent AE is any AE temporally associated with the use of study treatment whether or not considered by the investigator as related to study treatment.|From the first study drug intake up to 30 days after last study drug intake (Week 24)|The premature termination of the study led to a consequent lack of meaningful data. As the statistical analysis plan issued was not finalized and was not executed, no statistical analyses were performed. As there was only 1 patient enrolled in the study, the safety events reported occur with 100% frequency.|||Participants|||Count of Participants
1314062|NCT02461134|Primary|Change in Peripheral Absolute Lymphocyte Count From Baseline to Week 4, 8 and 12|The primary pharmacodynamic endpoint assesses intra-subject dose response during the first 12 weeks of treatment.|From baseline to Week 12|Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed. The statistical analysis plan issued is obsolete, it was not finalized and was therefore not executed.||||||
1314063|NCT02460991|Other Pre-specified|FACT-Hep Quality of Life|FACT-Hep quality of life instrument validated in patients with Hepatic cancer.|2 years|||||||
1314064|NCT02460991|Other Pre-specified|Proportion Achieved Tumor Response|The proportion of patients in each group that achieve complete response (CR), partial response (PR), and stable disease (SD) will be presented and compared across treatment groups.|2 years|||||||
1314065|NCT02460991|Secondary|Frequency of Treatment Emergent Adverse Events|The frequency of treatment emergent adverse events at 30 day, 3, 6, 9, 12, 18, and 24-months following the initial treatment. The proportions of patients in each arm experiencing treatment emergent adverse events will be presented descriptively with the number experiencing the event, the number evaluated, the percentage, and the exact two-sided 95% confidence interval.|2 years|||||||
1314066|NCT02460991|Secondary|Proportion Progression Free|Proportion Progression-Free (PPF) at one year|1 year|||||||
1314067|NCT02460991|Secondary|Time to Extrahepatic Spread|Time to Extrahepatic Spread for each subject|2 years|||||||
1314068|NCT02460991|Secondary|Time to Progression|Time to progression (TTP) determined by radiological assessment using mRECIST criteria|2 years|||||||
1314069|NCT02460991|Primary|Overall Survival|Overall survival in HCC subjects with minimum follow-up of subjects to at least one year|1 year|The planned analyses were not performed due to early termination.||||||
1314085|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314070|NCT02460822|Secondary|Improved Quality of Life|"The investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional). For each of the dimensions, patients are given a series of statements about specific elements of well being and asked to rank them on the following scale: Not at all, a little bit, Somewhat, Quite a bit, or Very much. These items are given numeric values of 0-4, with negatively worded statements reverse coded. Within each of the four dimensions of health, average scores are calculated, and then an overall sum is derived. Total well-being ranges from 0 (Complete lack of well being) to 16 (Completely well).~The number presented is the count of participants for whom the overall FACT-G score increased between baseline and 8-week followup. Because this is a small pilot study, we measure ANY increase with no threshold specified."|Baseline and 8 weeks post enrollment||||Participants|||Count of Participants
1314071|NCT02460822|Secondary|Symptom Burden Reduction|"The investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 8 core symptom areas (pain, fatigue, nausea, disturbed sleep, distress, lack of appetite, weakness, and diarrhea). For each area, patients are asked to rank their symptoms on a scale from 0 (Not present) to 10 (As bad as you can imagine). The overall score is the mean across all 8 items.~The number reported here is the count of patients with a reduction in symptom burden between baseline and 8-week follow up. Because this is a small pilot study, we measure ANY reduction with no threshold specified."|8 weeks post enrollment||||Participants|||Count of Participants
1314072|NCT02460822|Secondary|Increased Mastery of Cancer and Chemotherapy Symptoms|"The investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care. This scale is based on the Mastery Scale developed by Pearlin and Schooler, designed to capture the sense of control a patient feels over their cancer care. This is a 7-item scale where users are asked to respond to statements by choosing and answer from the following: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly agree. Mastery scores were computed by taking the numeric mean of the items (1-5), with negatively worded items reversed.~The number presented here is the number of patients whose mastery score improved between baseline and the end of the 8-week program. Because this is a small pilot study, we measure ANY improvement with no threshold specified."|8 weeks post enrollment||||Participants|||Count of Participants
1314073|NCT02460822|Secondary|Physician Use of the Study Feedback Mechanism|The investigators will assess for how many of the enrolled patients the physicians use the feedback from the app to assist in clinical care of the patients. This includes following up about distressing symptoms and using information provided by the patient during regular clinical visits.|8 weeks post-enrollment||||Participants|||Count of Participants
1314074|NCT02460822|Primary|Patient Satisfaction and Usability of the MyChemoCare Application|"The investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app.~This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree."|8 weeks post enrollment||||units on a scale||Standard Error|Mean
1314075|NCT02460822|Primary|Patient Retention and Engagement With the MyChemoCare Application|Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.|8 weeks post-enrollment||||Participants|||Count of Participants
1314076|NCT02460458|Primary|Type of VWF/FVIII-containing Concentrates in Use|Record of any VWF/FVIII-containing concentrates used and currently in use, including the current schedule type of treatment.|24 months (prospective phase)|||||||
1314077|NCT02460458|Primary|Adverse Events|Record of all adverse events occurred during the prospective phase of the study.|24 months (prospective phase)|||||||
1314078|NCT02460458|Primary|Record of Bleeding Episodes|Bleeding: severity, start date, stop date; Treatment: Product name, start date, stop date, Total IU, Total ED.|24 months (prospective phase)|||||||
1314079|NCT02460458|Primary|Allergic Reactions During Use of VWF-containing Concentrates|Record of any allergic and anaphilactic reactions occurred in the past due to the use of any VWF concentrate and the date of onset.|24 months (retrospective)||||participants|||Number
1314080|NCT02460458|Primary|Previous Use of Blood Products|Record of any product used in the previous 24 months (collected type of blood products/VWF concentrate, year of first exposure, units used).|24 months (retrospective)||||participants|||Number
1314081|NCT02460458|Primary|Molecular Diagnosis of VWF in DNA|Evaluation of the presence of VWF gene defects (confirmation or screening for the first time).|36 months (retrospective + confirmatory phase)|||||||
1314082|NCT02460458|Primary|Test for Anti-VWF Antibodies|Evaluation of the titre of Anti-VWF Antibodies through Bethesda test (BU).|36 months (retrospective + confirmatory phase)|||||||
1314083|NCT02460458|Primary|General Laboratory Tests for VWD3 Diagnosis (Composite)|Hemoglobin: (mmol/L), HT(%), MVC (fl); Leucocytes: (E9/L); Neutrophil (%); Basophil (%); Eosinophil (%); Lymphocyte (%); Platelet count: (E9/L), MPV (fl); Prothrombin Time (sec); PTT (sec); PTT mix 50:50 (sec); Ferritin (ug/l); Bleeding Time (min:sec); Closure Time (Sec); Collagen/ADP (sec); Collagen/Epinephrine (sec); FVIII:C (IU/mL); VWF:RCo (IU/mL); VWF:Ag (IU/mL).|36 months (retrospective + confirmatory phase)|||||||
1314084|NCT02460458|Primary|Bleeding Severity Score (BSS)|The range of measurement is from -1 to +4 for each symptom considered (12 symptoms, total range from -12 to 48). For each symptom: 0=no symptom, 1=referred by the patient, 2=brought to medical attention, 3=major intervention. For spontaneous hemorrhagic symptoms, scores equal or greater than two require that the patient has specifically addressed that hemorrhagic symptom with a physician, whatever has been the diagnosis and therapy subsequently proposed. Score 0 and 1 are attributed to symptoms referred by the patient, hence without any precise medical intervention. Score 0 is for negligible or absent symptoms; 1 otherwise. For surgical procedures, it is considered important to differentiate between patients that have never bled because they never underwent surgery and those that did not bled after a surgery. These latter receive a negative score, indicating that the probability of VWD diminishes if you don’t bleed after surgery.|24 months (retrospective phase)||||Score on a scale||Full Range|Median
1314105|NCT02459093|Primary|Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)|Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)|30 days|As treated|||Participants|||Count of Participants
1314086|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314087|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN|Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314088|NCT02460159|Primary|Percentage of Participants With Potential Hy's Law Condition|Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314089|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in ALT or AST ≥10 Times ULN|Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314090|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in ALT or AST ≥5 Times ULN|Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT or AST that were 5x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314091|NCT02460159|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)|Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314092|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Hepatitis-related AEs|Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314093|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs|Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314094|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Gallbladder-related AEs|Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for outcome.|||Percentage of Participants|||Number
1314095|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs|Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of participants|||Number
1314096|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized.|up to 54 Weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
1314097|NCT02459418|Secondary|Baseline Corrected E2 Tmax|"Tmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with Tmax estimated in both periods are included.|||hours||95% Confidence Interval|Median
1314098|NCT02459418|Secondary|Baseline Corrected E2 Cmax|"Cmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of Cmax are included.|||pg/mL||Full Range|Geometric Mean
1314099|NCT02459418|Secondary|Baseline Corrected 17ß-Estrodiol (E2) Serum Exposure AUC(0-last)|"AUC(0-last) was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of AUC(0-last) are included.|||pg*h/mL||Full Range|Geometric Mean
1314100|NCT02459418|Secondary|Baseline Corrected FSH Apparent Terminal Half-life|"Apparent terminal half-life was defined as ln2/apparent terminal rate constant (λz). λz is determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment was used to identify the terminal linear phase of the baseline corrected concentration-time profile. A minimum of 3 data points was used for determination.~Terminal half-life was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with suitable terminal phase profiles for determination of terminal half-life are included.|||hours||Full Range|Geometric Mean
1314101|NCT02459418|Secondary|Baseline Corrected Time to Reach Maximum FSH Serum Concentration (Tmax)|"Tmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with Tmax estimated in both periods are included.|||hours||95% Confidence Interval|Median
1314102|NCT02459418|Secondary|Baseline Corrected FSH Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)]|"AUC(0-∞) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with suitable terminal phase profiles for determination of AUC(0-∞) are included.|||ng*h/mL||Full Range|Geometric Mean
1314103|NCT02459418|Primary|Baseline Corrected FSH Maximum Serum Concentration (Cmax)|"Cmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of Cmax are included.|||ng/mL||Full Range|Geometric Mean
1314104|NCT02459418|Primary|Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]|"AUC(0-last) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.|Analysis was performed on the Pharmacokinetic Analysis Set (PKAS) which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of AUC(0-last) are included.|||nanograms*hours/mL (ng*h/mL)||Full Range|Geometric Mean
1314106|NCT02459093|Primary|Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)|Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)|30 days|Intent to treat analysis|||Participants|||Count of Participants
1314107|NCT02458768|Primary|Number of Retrieved Oocytes||36 hrs (±3 hrs) after administration of the ovulation stimulant|Per-Protocol Set|||Oocytes||Standard Deviation|Mean
1314108|NCT02458365|Other Pre-specified|Number of Participants Experiencing Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment experienced during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
1314109|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment perpetrated during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
1314110|NCT02458365|Other Pre-specified|Number of Participants Experiencing Physical Peer Violence During Follow-up|"See above. Cronbach's Alphas for the three victimization scales were .89 for emotional mistreatment, .89 for physical violence, and .93 for sexual coercion. One or more incidents of physical peer violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
1314111|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Physical Peer Violence During Follow-up|"Among participants not exposed to risk for dating violence, an 18-item measure assessed three types of peer violence perpetration and victimization (Levesque, 2007). Alphas for the three 3-item perpetrator scales are: .89 for emotional mistreatment, .89 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed peer violence experienced and perpetrated since January 1, 2010. Given the hierarchical structure of the perpetration measure, the physical violence and sexual coercion scales were combined to represent physical perpetration. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents coded as no."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
1314112|NCT02458365|Secondary|Number of Participants Experiencing Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
1314113|NCT02458365|Secondary|Number of Participants Perpetrating Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence perpetration during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
1314114|NCT02458365|Secondary|Number of Participants Experiencing Physical Dating Violence During Follow-up|"See above. Cronbach's Alphas for the five victimization scales were .87 for emotional mistreatment, .86 for controlling behavior, .83 for threats, .76 for physical violence, and .90 for sexual coercion. One or more incidents of physical dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
1314115|NCT02458365|Primary|Number of Participants Perpetrating Physical Dating Violence During Follow-up|"A 30-item measure assessing five types of dating violence perpetration and victimization was developed to meet specific needs of this research (Levesque, 2007). Alphas for the five 3-item perpetrator scales are: .88 for emotional mistreatment, .87 for controlling behavior, .91 for threats, .92 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed dating violence perpetrated and experienced since January 1, 2010. Given the hierarchical structure of the perpetration measure, the emotional mistreatment and controlling behavior scales were combined to represent emotional dating violence perpetration, and the threats, physical violence, and sexual coercion scales were combined to represent physical perpetration. Given extreme non-normal distributions, the two measures were then dichotomized. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents as no."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
1314116|NCT02458287|Secondary|Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12|PCSK9 is an enzyme encoded by the PCSK9 gene in humans on chromosome. It is the 9th member of the proprotein convertase family of proteins that activate other proteins.|Week 12|Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter||Standard Deviation|Mean
1314912|NCT02434497|Secondary|Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline TC/HDL-C|participants|95% Confidence Interval|Geometric Mean
1314117|NCT02458287|Secondary|Plasma Concentration of Bococizumab at Week 12||Week 12|Analysis set included all participants who received at least one dose of study medication. Participants who received at least 1 dose of Bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||microgram per milliliter||Standard Deviation|Mean
1314118|NCT02458287|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer levels >=6.23 were considered as ADA positive and participants with their nAb titer level >=1.58 were considered as nAb positive.|Baseline up to 18 weeks|Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1314119|NCT02458287|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 18 weeks), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 18 weeks|Safety analysis set included all participants who received at least one dose of study medication.|||participants|||Number
1314120|NCT02458287|Secondary|Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1314121|NCT02458287|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1314122|NCT02458287|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1314123|NCT02458287|Secondary|Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1314124|NCT02458287|Secondary|Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8|As per the OAT, a ‘successful’ injection was based on observer’s response for the question - “Was the administration successful?’’. Observer’s response being ‘Yes’ corresponded to a successful injection.|Week 0 (Day 1), 4, 8|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms as pre-specified in protocol.|||percentage of injections|injections||Number
1314125|NCT02458287|Secondary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10|A successful injection based on PAT was an injection where the participant answered “yes” to all the three questions: “Were you able to inject your medicine?” “Has the blue bar moved across the window?” Was the medicine not flowing after needle withdrawn?”|Week 0 (Day 1), 2, 4, 6, 8, 10|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
1314126|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10|A successful injection based on PAT was an injection where the participant answered “yes” to all the three questions: “Were you able to inject your medicine?” “Has the blue bar moved across the window?” Was the medicine not flowing after needle withdrawn?”|Week 10|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
1314127|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8|A successful injection based on PAT was an injection where the participant answered “yes” to all the three questions: “Were you able to inject your medicine?” “Has the blue bar moved across the window?” Was the medicine not flowing after needle withdrawn?”|Week 8|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
1314128|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6|A successful injection based on PAT was an injection where the participant answered “yes” to all the three questions: “Were you able to inject your medicine?” “Has the blue bar moved across the window?” Was the medicine not flowing after needle withdrawn?”|Week 6|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
1314594|NCT02444715|Primary|Change in HbA1c Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HbA1c data is missing for 21 of the 46 SC and 21 of the 48 IC participants who started the study.|||percent HbA1c||Inter-Quartile Range|Median
1314129|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4|A successful injection based on PAT was an injection where the participant answered “yes” to all the three questions: “Were you able to inject your medicine?” “Has the blue bar moved across the window?” Was the medicine not flowing after needle withdrawn?”|Week 4|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
1314130|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2|A successful injection based on PAT was an injection where the participant answered “yes” to all the three questions: “Were you able to inject your medicine?” “Has the blue bar moved across the window?” Was the medicine not flowing after needle withdrawn?”|Week 2|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
1314131|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)|A successful injection based on PAT was an injection where the participant answered “yes” to all the three questions: “Were you able to inject your medicine?” “Has the blue bar moved across the window?” Was the medicine not flowing after needle withdrawn?”|Week 0 (Day 1)|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
1314132|NCT02458287|Primary|Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1314133|NCT02457793|Secondary|Change From Baseline in Tumor Tissue Biomarkers||Up to 3 years|Data for this measure were not collected.||||||
1314134|NCT02457793|Secondary|Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)||Day 15 of study|Data for this measure were not collected.||||||
1314135|NCT02457793|Secondary|Mean Terminal Half-life (t1/2)||Up to day 22 of study|Data for this measure were not collected.||||||
1314136|NCT02457793|Secondary|Mean Accumulation Ratio||Up to 3 years|Data for this measure were not collected.||||||
1314137|NCT02457793|Secondary|Total Exposure (AUC From Time 0 to 24 Hour After Dose) for Cobimetinib||Up to Day 22|Data are reported for evaluable participants.|||ng x hr/mL||Geometric Coefficient of Variation|Geometric Mean
1314138|NCT02457793|Secondary|Total Exposure (AUC From Time 0 to 24 Hour After Dose) for GDC-0994|Data are reported for evaluable participants.|Up to Day 22|Data are reported for evaluable participants.|||hours times micromoles||Geometric Coefficient of Variation|Geometric Mean
1314139|NCT02457793|Secondary|Median Time to Maximum Serum Concentration (Tmax) for Cobimetinib||Up to Day 22|Data are reported for evaluable participants.|||hours||Full Range|Median
1314140|NCT02457793|Secondary|Maximum Serum Concentration (Cmax) for Cobimetinib||Up to Day 22|Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1314141|NCT02457793|Secondary|Median Time to Maximum Serum Concentration (Tmax) for GDC-0994||Up to Day 22|Data are reported for evaluable participants.|||hours||Full Range|Mean
1314142|NCT02457793|Secondary|Maximum Serum Concentration (Cmax) for GDC-0994||Up to Day 22|Data are reported for evaluable participants.|||micromoles||Geometric Coefficient of Variation|Geometric Mean
1314143|NCT02457793|Primary|Mean Change From Baseline in Weight||Up to 3 years|All participants. Data are reported for evaluable participants.|||kg||Standard Deviation|Mean
1314144|NCT02457793|Primary|Mean Change From Baseline in Temperature||Up to 3 years|All participants. Data are reported for evaluable participants.|||degrees Celsius||Standard Deviation|Mean
1314145|NCT02457793|Primary|Mean Change From Baseline in Systolic Blood Pressure||Up to 3 years|All participants. Data are reported for evaluable participants.|||mm Hg||Standard Deviation|Mean
1314146|NCT02457793|Primary|Mean Change From Baseline in Respiratory Rate||Up to 3 years|All participants. Data are reported for evaluable participants.|||breaths per minute||Standard Deviation|Mean
1314147|NCT02457793|Primary|Mean Change From Baseline in Pulse Rate||Up to 3 years|All participants. Data are reported for evaluable participants.|||beats per minute||Standard Deviation|Mean
1314148|NCT02457793|Primary|Mean Change From Baseline in Lean Body Mass||Day 15|All participants. Data are reported for evaluable participants.|||kilograms (kg)||Standard Deviation|Mean
1314149|NCT02457793|Primary|Mean Change From Baseline in Diastolic Blood Pressure||Up to 3 years|All participants. Data are reported for evaluable participants.|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
1314150|NCT02457793|Primary|Percentage of Participants With Laboratory Abnormalities|"Laboratory abnormalities were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0.~SGPT/ALT - serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST - serum glutamic oxaloacetic transaminase/aspartate aminotransferase"|Up to 3 years|All participants. Data are reported for evaluable participants.|||percentage of participants|||Number
1314151|NCT02457793|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE)|A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.|Up to 3 years|All participants.|||percentage of participants|||Number
1314186|NCT02455388|Secondary|Diagnostic Value of d13C Biomarker|Determine diagnostic value of d13C biomarker using fingerstick blood. The area under the ROC was used as a measure for the diagnostic accuracy of the d13C biomarker, with values closer to 1.0 indicating greater ability to distinguish between low and high added sugar and sugar sweetened beverage consumers.|2-3 weeks||||Area under the ROC curve||95% Confidence Interval|Number
1314152|NCT02457793|Primary|Percentage of Participants With at Least One Adverse Event of Special Interest|AESIs were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0. AESIs included the following: Grade ≥ 1 retinal vein occlusion; Grade ≥ 2 visual disturbances (including events suggestive of serous retinopathy); Grade ≥ 3 rash for > 7 days; Grade ≥ 3 diarrhea for > 3 days; Grade ≥ 2 left ventricular ejection fraction (LVEF) decrease; Grade 3 hepatotoxicity; any dose-limiting toxicity (DLT); cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST > 3 × baseline value [and above the upper limit of normal, ULN]) in combination with either an elevated bilirubin ( > 2 × ULN) or clinical jaundice; or suspected transmission of an infectious agent by either study drug.|Up to 3 years|All participants.|||percentage of participants|||Number
1314153|NCT02457793|Primary|Percentage of Participants With at Least One Adverse Event|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|Up to 3 years|All participants.|||percentage of participants|||Number
1314154|NCT02457793|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLTs include symptoms considered by the investigator to be possibly related to study drug.|Up to 3 years|All participants.|||number of participants|||Number
1314155|NCT02457728|Primary|Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.|Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.|During hospitalization and 6 weeks after surgery.||||participants|||Number
1314156|NCT02457611|Secondary|Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4||Baseline; Week 6; Posttreatment Week 4|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Standard Deviation|Mean
1314157|NCT02457611|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4||Weeks 2, 4, 6, and Posttreatment Week 4|Participants in the Safety Analysis Set who had HIV-1 RNA < 50 copies/mL at Baseline were analyzed.|||percentage of participants||95% Confidence Interval|Number
1314158|NCT02457611|Secondary|Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.|Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.|Day 1; Week 6|Safety Analysis Set|||Participants|||Count of Participants
1314159|NCT02457611|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
1314160|NCT02457611|Secondary|Change From Baseline in HCV RNA at Weeks 2, 4, and 6||Baseline; Weeks 2, 4, and 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1314161|NCT02457611|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 2, 4, and 6|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1314162|NCT02457611|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)|SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1314163|NCT02457611|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 6 weeks|Safety Analysis Set|||percentage of participants|||Number
1314164|NCT02457611|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants with genotype 1 or 4 HCV infection who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1314165|NCT02457260|Secondary|Serology-platelet Bioenergetics-1|Platelet bioenergetics (using Seahorse XF analysis), i.e., extracellular acidification rate.|Baseline; PRE and 4 weeks; POST|Patients that completed pre post testing in each of the three arms were include in analysis. 6 subjects withdrawn from the study.|||mpH/min||Standard Deviation|Mean
1314166|NCT02457260|Secondary|Serology-plasma Nitrite and Nitrate|plasma nitrite and plasma nitrate levels pre and post 4 week intervention|Baseline; PRE and 4 weeks; POST|On analysis of data for this report it was found that three control samples had been missed on initial running of nitrate/nitrite bring the N=7 for that assessment. 6 subjects withdrawn from the study.|||µm||Standard Deviation|Mean
1314167|NCT02457260|Secondary|Serology-Inflammatory Marker|Inflammatory marker (C-reactive protein [CRP])|Baseline; PRE and 4 weeks; POST|Patients that completed pre post testing in each of the three arms were include in analysis. 6 subjects withdrawn from the study.|||mg/L||Standard Deviation|Mean
1314168|NCT02457260|Secondary|Quality of Life Assessment- In Heart Failure|Kansas City Cardiomyopathy Questionnaire (KCCQ)- is a standard tool to assess the quality of life of the heart failure patients. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains with the higher the score (0-100) the better the health status.|Baseline; PRE and 4 weeks; POST|Kansas City Cardiomyopathy Questionnaire (KCCQ)- is a standard tool to assess the quality of life of the heart failure patients. Control patients were not assessed via KCCQ given it is not a valid tool for healthy. All HF patients that completed pre and post assessment were analyzed. 6 subjects withdrawn from the study.|||scores on a scale||Standard Deviation|Mean
1314913|NCT02434497|Secondary|Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline LDL-C/HDL-C|participants|95% Confidence Interval|Geometric Mean
1314169|NCT02457260|Secondary|Measures of Physical Function- Balance|Balance was assessed as part of the short performance physical battery (SPPB). This assessment evaluates three components of static stand (stands with their feet together), semi tandem (stand with the heal of one foot beside the toe of the other foot), Tandem (stands with one foot directly in front of the other). Each test is held for as many seconds as they can up to ten seconds. Static and semi tandem if held for 10 second counts as 1 point if not held it is 0 points, tandem stand if held for 10 second is 2 points, if held for 3 to9.99 it is 1 point, otherwise 0 points. Total points are added up for all balance tests for a composite score with the higher the score the better and maximum being 4, minimum 0.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||scores on a scale||Standard Deviation|Mean
1314170|NCT02457260|Secondary|Measures of Physical Function- Handgrip|Handgrip is used as a measure of upper body strength. three trials on each hand were completed with the patient seated and the arm at a right angle. For the purposes of this analysis all trials were averaged together.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||kg||Standard Deviation|Mean
1314171|NCT02457260|Secondary|Measures of Physical Function- Gait Speed|4 meter gait speed assessed as part of the short performance physical battery (SPPB). This assessment evaluates how long it take a person can cover four meters at their usual walking speed from a stop when a person says go. This was completed twice to find the fastest speed was used as the variable.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||seconds||Standard Deviation|Mean
1314172|NCT02457260|Secondary|Measures of Physical Function- Cardiopulmonary Exercise Test (CPX)|Continuous metabolic gas collection or a cardiopulmonary exercise test occurred during a constant speed-steady state treadmill walking protocol (1.5mph at a 0% grade) for 5 minutes. During the final minute of the walking protocol oxygen consumption (VO2) was assessed to determined if the patient reached steady state VO2. Steady state VO2 was assessed by a less than 5% change in VO2 for a 30 second period of time. The 30 second average time is represented below in units of measure ml/kg/min. This is to show change in efficiency of performance of the constant speed test a decrease in VO2 from pre to post indicates greater efficiency.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||ml/kg/min||Standard Deviation|Mean
1314173|NCT02457260|Secondary|Serology-platelet Bioenergetics|Platelet bioenergetics (using Seahorse XF analysis), i.e., including glycolytic(OLIGO) as well as basal and maximal respiratory rates and extracellular acidification rate.|Baseline; PRE and 4 weeks; POST|Patients that completed pre post testing in each of the three arms were include in analysis. 6 subjects withdrawn from the study.|||pmol/minute||Standard Deviation|Mean
1314174|NCT02457260|Primary|Skeletal Muscle Bioenergetics - Mitochondrial Function|Obtained via analysis of skeletal muscle biopsy of the vastus lateralis, Mitochondrial function was assessed using respirometry (State 3.12).|Baseline; PRE and 4 weeks; POST|2 Controls, 1 HFpEF and 1 HFrEF have no data for mitochondrial function due to no FCCP response or potential cytochrome c response. 6 subjects withdrawn from the study.|||nmol O / sec/ mg||Standard Deviation|Mean
1314175|NCT02457260|Primary|Skeletal Muscle Bioenergetics- Polymerase Chain Reaction (PCR)|Obtained via analysis of skeletal muscle biopsy of the vastus lateralis, Polymerase chain reaction (PCR) to assess pertinent gene expression within the pathways of ubiquitin [muscle ring finger protein 1 (MuRF), Atrogin1, Forkhead Box 03 (FoxO)], additionally Fibronectin type III domain-containing protein 5, the precursor of irisin (FNDC5), Peroxisome proliferator-activated receptor gamma co activator 1-alpha (PGC1α), and Sirtuin 3 were assessed.|Baseline; PRE and 4 weeks; POST|Health Control- 2 and 1 HFrEF participants have missing data for the gene analysis due to muscle samples not providing a clean reference value for inclusion of data analysis.. 6 subjects withdrawn from the study.|||Relative Expression||Standard Deviation|Mean
1314176|NCT02457247|Secondary|Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 28|The Safety Analysis Set included all randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1314177|NCT02457247|Secondary|Product Acceptability After Each 14 Day Dosing Period Within Each Test Group|Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect.|Day 14 and Day 28|The FAS included all randomized participants.|||mm||Standard Error|Least Squares Mean
1314178|NCT02457247|Primary|Percentage of Participants With a Preference for Each Treatment Within Each Test Group|Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D.|Day 28|All randomized participants from the Full Analysis Set (FAS) who received at least 1 dose of study medication and responded to the preference questionnaire.|||percentage of participants|||Number
1314187|NCT02455388|Secondary|Change in d13C: delta13C Added Sugar Biomarker|Validity, reliability and sensitivity of the fingerstick blood delta13C AS biomarker during feeding study. Participants are provided 7 days of food with high or low added sugar diet. Blood samples will be obtained each day via fingerstick to analyze delta13C biomarker levels.|Two 7-day feeding periods, randomized order, with a four-week washout between feeding periods. Outcome is a change in d13C from day 1 to 7, for each feeding period.||2018-11-30|11/2018||||
1314595|NCT02444715|Primary|Change in Triglyceride Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Triglyceride data is missing for 16 of the 46 SC and 16 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
1314179|NCT02456740|Secondary|Change From Baseline in Mean Monthly Average Impact on Everyday Activities Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from “Without any difficulty” (1) to “Unable to do” (5) and frequency items ranging from “None of the time” (1) to “All of the time” (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 – 100, with higher scores representing greater impact of migraine.~Change from baseline was calculated as (mean monthly impact on everyday activities scores as measured by the MPFID over the last 3 months of the double-blind treatment period) – (baseline monthly impact on everyday activities scores as measured by the MPFID)."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on everyday activities domain score in the double-blind treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1314180|NCT02456740|Secondary|Change From Baseline in Mean Monthly Average Physical Impairment Domain Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from “Without any difficulty” (1) to “Unable to do” (5) and frequency items ranging from “None of the time” (1) to “All of the time” (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 – 100, with higher scores representing greater impact of migraine.~Change from baseline was calculated as (mean monthly average physical impairment scores as measured by the MPFID over the last 3 months of the double-blind treatment period) – (baseline monthly average physical impairment scores as measured by the MPFID)."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average physical impairment domain score in the double-blind treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1314181|NCT02456740|Secondary|Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period|"Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.~The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment phase – the number of migraine-specific treatment days during the 4-week baseline phase."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly acute migraine-specific treatment days in the double-blind treatment phase.|||Acute migraine-specific med days/mo||Standard Error|Least Squares Mean
1314182|NCT02456740|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days in the Last 3 Months of the Double-blind Treatment Phase|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura.~At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 3 months (mean of months 4, 5 and 6) of the 24-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase. Participants with missing data at months 4, 5, and 6 were counted as non-responders.|||percentage of participants|||Number
1314183|NCT02456740|Primary|Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase – the number of migraine days during the 4-week baseline phase."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase.|||migraine days / month||Standard Error|Least Squares Mean
1314184|NCT02455518|Secondary|Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores|Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)|1 hour||||units on a scale||95% Confidence Interval|Number
1314185|NCT02455518|Primary|Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores|Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)|2 hours||||units on a scale||95% Confidence Interval|Number
1314208|NCT02454959|Secondary|Cmax on Day 8|Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population|||pg/mL||Standard Deviation|Mean
1314188|NCT02455388|Primary|delta13C Added Sugar Biomarker|Validity, reliability, and sensitivity of the fingerstick blood d13C AS biomarker during cross-sectional data collection. Participants will provide 4 separate self-reported, record-assisted 24-hr food intake recalls, and at two of the visits, a fingerstick blood sample will be collected to analyze delta13C biomarker levels.|2-3 weeks||||‰ δ13C||Standard Deviation|Mean
1314189|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
1314190|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||score on a scale||Standard Deviation|Mean
1314191|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 2|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||seconds||Standard Deviation|Mean
1314192|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 1|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||seconds||Standard Deviation|Mean
1314193|NCT02455050|Secondary|Distance Visual Acuity in Period 2|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||Letters Read Correctly||Standard Deviation|Mean
1314194|NCT02455050|Secondary|Distance Visual Acuity in Period 1|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||Letters Read Correctly||Standard Deviation|Mean
1314195|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 6 participants.|||percentage of participants|||Number
1314196|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 3 participants.|||percentage of participants|||Number
1314197|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
1314209|NCT02454959|Secondary|AUC0-12 on Day 8|Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h*pg/mL||Standard Deviation|Mean
1314198|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||score on a scale||Standard Deviation|Mean
1314199|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||percentage of participants|||Number
1314200|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||percentage of participants|||Number
1314201|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
1314202|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||score on a scale||Standard Deviation|Mean
1314203|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
1314204|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Participants enrolled in Period 1.|||score on a scale||Standard Deviation|Mean
1314205|NCT02454959|Secondary|Tmax on Day 8|Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h||Full Range|Median
1314206|NCT02454959|Secondary|Tmax on Day 8|Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h||Full Range|Median
1314207|NCT02454959|Secondary|Cmax on Day 8|Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population|||pg/mL||Standard Deviation|Mean
1314211|NCT02454959|Primary|Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8|AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.|7 days of treatment|The primary analysis used the Modified-Intent-to-Treat (MITT) Population.|||Liter||Standard Error|Least Squares Mean
1314212|NCT02454933|Primary|Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab|As a measure of the safety and tolerability of osimertinib in combination with durvalumab the number of subjects who experienced any treatment emergent AE (TEAE), any causally related AE, any serious AE (SAE), and any causally related SAE are presented.|From Baseline up to 3 months after the last dose (up to 24 months).|The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.|||Participants|||Count of Participants
1314213|NCT02454608|Primary|Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)|Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.|baseline to week 56|Intention-to-treat analysis|||units on a scale||Standard Error|Mean
1314214|NCT02454608|Primary|Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)|Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome|baseline to week 56|Intention-to-treat analysis|||units on a scale||Standard Error|Mean
1314215|NCT02454608|Other Pre-specified|Diastolic Blood Pressure||Mean change between baseline and week 8 measurements||||mmHg||Standard Deviation|Mean
1314216|NCT02454608|Other Pre-specified|Systolic Blood Pressure||Mean change between baseline and week 8 measurements||||mmHg||Standard Deviation|Mean
1314217|NCT02454608|Other Pre-specified|Heart Rate||Mean change between baseline and week 8 measurements.||||beats per minute||Standard Deviation|Mean
1314218|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-McKay Score(LMS)|Minimum Score: 0 Maximum Score: 24 Higher value represents worse outcome.|Week 8|Intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
1314219|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-Kennedy Score(LKS)|Minimum Score: 0 Maximum Score: 12 Higher value represents worse outcome.|baseline to week 8|Intention-to-treat analysis|||units on a scale||Standard Error|Least Squares Mean
1314220|NCT02454608|Primary|Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)|Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.|baseline to week 8|Intention-to-treat analysis|||units on a scale||Standard Error|Least Squares Mean
1314221|NCT02454608|Primary|Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)|Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome|baseline to week 8|Intention-to-treat analysis|||units on a scale||Standard Error|Least Squares Mean
1314222|NCT02454296|Secondary|Paracervical or Sham Block Pain|Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.|Within 10 seconds after receiving paracervical or sham block||||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
1314223|NCT02454296|Secondary|Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)|Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied|15 minutes post-operatively||||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
1314224|NCT02454296|Primary|Pain After Placement of Laminaria (100 mm Visual Analog Scale)|We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.|Measured within 10 seconds after placement of laminaria||||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
1314225|NCT02454283|Secondary|Length of Stay (From Time of Study Drug Administration)||8 days||||days||Standard Deviation|Mean
1314226|NCT02454283|Primary|Conversion to Sinus Rhythm|Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.|24 hours||||participants|||Number
1314227|NCT02454127|Secondary|C-reactive Protein|Change from baseline high-sensitivity CRP at 1 year, measured in mg/L|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||mg/L||Standard Deviation|Mean
1314228|NCT02454127|Secondary|Insulin|Change from baseline insulin at 1 year, measured in microIU/mL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values|||microIU/ml||Standard Deviation|Mean
1314229|NCT02454127|Secondary|Glucose|Change from baseline glucose at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||mg/dL||Standard Deviation|Mean
1314230|NCT02454127|Secondary|Triglycerides|Change from baseline triglycerides at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values|||mg/dL||Standard Deviation|Mean
1314231|NCT02454127|Secondary|HDL Cholesterol|Change from baseline HDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||mg/dL||Standard Deviation|Mean
1314232|NCT02454127|Secondary|LDL Cholesterol|Change from baseline LDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values|||mg/dL||Standard Deviation|Mean
1314233|NCT02454127|Secondary|Total Cholesterol|Change in total cholesterol from baseline at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline data.|||mg/dL||Standard Deviation|Mean
1314234|NCT02454127|Primary|Weight Loss|Change from baseline body weight at 1 year, measured in kilograms|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||kg||Standard Deviation|Mean
1314235|NCT02454101|Secondary|Duration of Third Stage of Labor|number of minutes from delivery of the baby till delivery of the placenta|immediatly after delivery||||minutes||Standard Deviation|Mean
1314236|NCT02454101|Secondary|Maternal Additional Need for Therapeutic Uterotonics|number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery|1st 24 hours of delivery||||participants|||Number
1314238|NCT02454101|Secondary|Neonatal Apgar Score (After 5 Minutes of Delivery).|"The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's:~Breathing effort~Heart rate~Muscle tone~Reflexes~Skin color~Each category is scored with 0, 1, or 2, depending on the observed condition.~The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.~A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.~Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs"|5 minutes of delivery|Number of Infants Analyzed|||Scores on a Scale from 1 to 10||Standard Deviation|Mean
1314239|NCT02454101|Secondary|Neonatal Intensive Care Unit (NICU) Admission|number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery|1st 24 hours after delivery|Number of Infants Analyzed|||participants|||Number
1314240|NCT02454101|Secondary|Neonatal Intubation|number of newborns requirng intubation in the first 2 hours after delivery|1st 2 hours after delivery|Number of Infants Analyzed|||participants|||Number
1314241|NCT02454101|Secondary|Severe Postpartum Haemorrage|(measured blood loss 1000 mL or more|24 hours after labor||||participants|||Number
1314242|NCT02454101|Secondary|Jundice Requring Phtotherapy|number of infants requiring phtotherapy for jundice in the first 2 weeks|two weks|Number of Infants Analyzed|||participants|||Number
1314243|NCT02454101|Primary|Neonatal Hemoglobin Level|neonatal 6 weeks hemoglobin measured in gram %|6 weeks after labor|Number of Infants Analyzed|||gram%||Standard Deviation|Mean
1314244|NCT02453581|Primary|500mg Cohort Mean Parasite Reduction Ratio (PRR)|OZ439 500mg individual subject PRR and corresponding 95% CI were used to calculate the OZ439 500mg cohort specific PRR and the corresponding 95% CI: the weighted average slope estimate and corresponding SE were calculated by the inverse-variance method.|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3. With a p value of 0.0046, Subject S036 was excluded from this calculation|||none (ratio)||95% Confidence Interval|Mean
1314245|NCT02453581|Secondary|OZ439 AUC(0-144)|OZ439 Area under the curve to 144 hours|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1314246|NCT02453581|Secondary|OZ439 Cmax|OZ439 Maximum concentration (Cmax)|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314247|NCT02453581|Primary|Individual Parasite Reduction Ratio (PRR)|"PRR estimates the efficacy of an anti-malarial treatment and is the ratio of the parasite density between admission and 48 hours post-treatment.~Individual subject PRR and corresponding 95% CI were calculated using the slope and corresponding standard error of mean (SE) of the optimal regression model."|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3.|||none (ratio)||95% Confidence Interval|Number
1314248|NCT02453347|Secondary|Sleep - Pittsburgh Sleep Quality Index (PSQI)|"To assess for improvements in measures of somatic symptoms related to TBI (insomnia). The scoring consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.~Each item is weighted on a 0–3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality."|Four Weeks||||scores on a scale||Standard Deviation|Mean
1314249|NCT02453347|Secondary|Headache - HIT6 (Headache Impact Test)|To assess for improvements in measures of somatic symptoms related to TBI (headaches). The test is scored by adding points to 6 different categories related to frequency and severity of symptoms. The 6 category scores are summed to yield a total score ranging from 36 to 78. Fewer points signify less severity and higher point scores signify more severe symptoms according to patient assessment.|Four Weeks||||scores on a scale||Standard Deviation|Mean
1314250|NCT02453347|Secondary|Dizziness- NSI (Neurobehavioral Symptom Inventory)|To measure the effect of CES use on somatic symptoms related to TBI (Traumatic Brain Injury), including dizziness. The assessment scale rate 22 symptoms that may have disturbed subjects from 0 = no symptoms to 4 = very severe in the previous 2 weeks. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater the symptoms.|Four Weeks||||scores on a scale||Standard Deviation|Mean
1314251|NCT02453347|Primary|WAIS Coding - Wechsler Adult Intelligence Scale|"The test has two batteries of subtests grouped into two general areas: 1) Verbal scales; and 2) Performance scales. The Verbal scales measure general knowledge, language, reasoning, and memory skills, while the Performance scales measure spatial, sequencing, and problem-solving skills.~The tests are administered to individual examinees by trained examiners, using a complex set of test materials. Testing requires approximately 90 minutes. Raw scores on each test are converted to standard scores with a mean of 10 and a standard deviation of 3. Scale scores in the Verbal battery are summed and converted to a Verbal Intelligence Quotient (IQ) score; the same is done for the Performance scale scores which yield the Performance IQ score. In turn, the Verbal and Performance IQ scores are summed and converted to obtain the Full Scale (overall) IQ score with a mean of 100 and a standard deviation of 15. Higher scores indicate a higher IQ."|4 weeks||||scores on a scale||Standard Deviation|Mean
1314252|NCT02453347|Primary|WAIS (Wechsler Adult Intelligence Scale) Symbol Search|The Symbol Search subtest of the Wechsler Adult Intelligence scale designed to assess information processing speed and visual perception with a minimum score of 0 as the lowest (worst performance) to 60 as the highest score (best performance).|4 weeks||||scores on a scale||Standard Deviation|Mean
1314443|NCT02447458|Secondary|Renal Clearance (CLr) of MLN3126 and Metabolite M-I|Renal clearance was calculated as CLr=Ae(0-96)/AUC (0-96).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.|||mL/min||Standard Deviation|Mean
1314253|NCT02453347|Primary|MPAI (Mayo Portland Adaptability Inventory)|The inventory consists of 29 items in 3 subscales (Ability, the Adjustment and Participation Index) plus an additional 6 items that are not included in the MPAI-4 score. The first 29 scale items are intended to reflect the current status of the individual with brain injury without attempting to determine whether their status might be influenced by factors other than ABI (acquired brain injury). Items are scored from 0 to 4, with 0 being the most favorable score for each item, with a cumulative score ranging from 0 to 116 for all the items. A lower score indicates better adaptability.|4 weeks||||scores on a scale||Standard Deviation|Mean
1314254|NCT02453347|Primary|TFI (Tinnitus Functional Index)|To measure the severity of tinnitus. The survey consists of 25 questions ranked from 0 (did not interfere) to 10 (completely interfered). At least 19 of the 25 questions are required to be answered, and rankings are added together to give a maximum possible score of 250, which would be the most severe interference by tinnitus.|4 weeks||||scores on a scale||Standard Deviation|Mean
1314255|NCT02453347|Primary|Beck Depression Inventory (BDI)|"A 21 question set to assess subjects feelings in the last week. Each question has a set of at least 4 possible responses, ranging in intensity:~(0) I do not feel sad.~I feel sad.~I am sad all the time and I can't snap out of it.~I am so sad or unhappy that I can't stand it. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score ranging from 0 to 63 is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms."|4 weeks||||score||Standard Deviation|Mean
1314256|NCT02453347|Primary|State-Trait Anxiety Inventory (STAI)|To measure the effect of CES use on trait and state anxiety. These scales comprise 20 items each and are scored on 4-point forced-choice response scales from 1 (seldom) to 4 (frequent). Scores range from 20 to 80, with higher scores suggesting greater levels of anxiety.The state and trait anxiety scales both range from 20 to 80 and are combined to yield a total score ranging from 40 to 160, where low scores suggest mild anxiety, median scores suggest moderate anxiety, and high scores suggest severe anxiety. Both scales include direct (presence of anxiety) and reverse-worded (absence of anxiety) items. Reverse-worded item scores are reverse scored and then totaled with the remaining items.|Four Weeks||||scores on a scale||Standard Deviation|Mean
1314257|NCT02453347|Primary|PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms|"To measure the effect of Cranial Electrotherapy Stimulation (CES) use on symptoms related to PTSD.~The PCL-5 is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study.~The survey has 20 questions scored as:~0=Not at all~A little bit~Moderately~Quite a bit~Extremely Interpretation of the PCL-5 should be made by a clinician. The total symptom severity score is obtained by summing the scores for each of the 20 items and ranges from 0 to 80. The lower the score, the less severe the symptoms of PTSD, the higher the score, the more severe the symptoms. For a person to have a probable diagnosis of PTSD sufficient criteria must be moderately to extremely met in each of the four symptom groups (i.e., one or more of questions 1-5, either question 6 or 7, two or more of questions 8-14, two or more of questions 15-20). In addition, a score of 38 or higher indicates probable PTSD in veterans."|Four Weeks||||scores on a scale||Standard Deviation|Mean
1314258|NCT02453321|Secondary|Sustained Straight Leg Raise|Sustained Straight Leg Raise is the ability to elevate the heel and leg/knee off of bed for 5 seconds postoperatively after spinal anesthetic has resolved contralaterally.|Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atempt||||Participants|||Count of Participants
1314259|NCT02453321|Secondary|Postoperative Pain, Average Reported Score 11-point Scale|The outcome is measured using a Numeric pain scale. The patient reports their average pain felt on postoperative day one, on a scale of 0 to 10 inclusive. Zero in this case indicates no pain at all and 10 indicates the worst pain they have ever felt.|postoperative day one||||units on scale||Standard Deviation|Mean
1314260|NCT02453321|Secondary|Average Length of Stay (to be Reported in Hours After Surgery)|If pain is controlled and rehabilitation activity is optimal patient may be discharged at an earlier time|Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded.||||Hours||Inter-Quartile Range|Median
1314261|NCT02453321|Primary|Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}|Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.|Participants will be followed for the duration of hospital stay, an average of 4 days||||Hours||Inter-Quartile Range|Median
1314262|NCT02452944|Secondary|Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease|We checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.|up to 8 weeks||||participants|||Number
1314263|NCT02452944|Primary|Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group|"We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients.~In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a ‘fail’."|up to 8 weeks||||participants|||Number
1314310|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan)|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||percent of dose||Standard Deviation|Mean
1314311|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-II|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Standard Deviation|Mean
1314264|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4|"The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.~This analysis outcome approach took Incorrect Item #2 and imputed using worst possible value."|Day 4, Week 1|"Full analysis set, Week 1.Item #2 was incorrectly listed as Disinterested instead of Distressed.resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details."|||units on a scale||95% Confidence Interval|Least Squares Mean
1314265|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4|"The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.~This analysis outcome treated Incorrect Item #2 where Item #2 data was removed."|Day 4|"Full analysis set, Week 1.Item #2 was incorrectly listed as Disinterested instead of Distressed.resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details."|||units on a scale||95% Confidence Interval|Least Squares Mean
1314266|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4|"The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.~This analysis outcome treated Item #2 as random missing data."|Day 4, Week 1|Full analysis set, Week 1.Item #2 was incorrectly listed as “Disinterested” instead of “Distressed”.resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.|||units on a scale||95% Confidence Interval|Least Squares Mean
1314267|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score|The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Used as a psychometric scale, the PANAS can show relationships between positive and negative affect with personality stats and traits. Descriptors are used to define their meanings. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).To calculate the positive affect score, added scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10-50, which higher scores representing higher levels of positive affect, or the extent to which the individual feels enthusiastic, active and alert.|Day 4 Week 1|Full Analysis Set (Week 1).|||units on a scale||95% Confidence Interval|Least Squares Mean
1314268|NCT02452892|Post-Hoc|Montgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4)|"The MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in subjects with Major Depressive Disorder (MDD). Individual items are rated on a scale of 0 to 6 in which a score of 6 represents the most severe symptoms for each item assessed. The total score ranges from 0 to 60.~Remission of depression based on the MADRS is defined as a subject with a MADRS total score of ≤11 at endpoint. A responder on the MADRS is defined as a 50% or greater reduction from baseline in total MADRS score"|Day 4 Week 1|Full Analysis Set, Week1|||units on a scale||95% Confidence Interval|Least Squares Mean
1314269|NCT02452892|Secondary|Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score|"To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous (yes or no) were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates."|Day 42|Subjects who were HAM-D6 Day 4 responders, defined as those subjects who achieved a 50% or greater decrease in their HAM-D6 total score compared to Baseline ( Day1, Wk 1).|||percentage of LFMS responders|||Number
1314270|NCT02452892|Secondary|Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS|"Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4.~To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11.~Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more."|Day 11 (Week 2)|Only non-responders at end of Day 4 comprise this Wk 2 analysis . (Non-responders were defined as those who didn't reach a decrease in 6-item Hamilton Rating Scale for Depression (HAM-D6) total score of 50% compared to baseline Day 1, Week 1). 41 subjects entered Week 2: 1 subject withdrew consent on Day 8 and was not part of the Full Analysis Set.|||units on a scale||95% Confidence Interval|Least Squares Mean
1314271|NCT02452892|Primary|Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.|"Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline.~Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more."|Week 1 Day 4|Subjects in the All Randomized set who completed at least one treatment session and had at least one post baseline primary efficacy assessment.|||units on a scale||95% Confidence Interval|Least Squares Mean
1314272|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314273|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: Cmax||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on subjects receiving ARC-520. At the time of study termination only 2 ARC-520 treated subjects had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314274|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: AUClast||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314275|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: AUC0-24||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314276|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314277|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314278|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314279|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Apparent Clearance (CL)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314280|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314281|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314282|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314283|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
1314312|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-II|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Full Range|Median
1314313|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1314284|NCT02452528|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication.|From time of informed consent through Day 147 ± 3 days|All participants who received at least 1 dose of ARC-520 or placebo|||Participants|||Count of Participants
1314285|NCT02452528|Primary|Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85||Baseline, Day 85|At the time of study termination only 2 ARC-520-treated and 2 placebo-treated participants had been enrolled. Due to the small sample size, analysis of this primary endpoint was not performed.||||||
1314286|NCT02452346|Secondary|One Year and Two Year Survival||from start of treatment to 1 year and 2 years post treatment initiation||||Participants|||Count of Participants
1314287|NCT02452346|Secondary|Overall Response|Overall response according to IWG 2006 criteira|Approximately 3 years||||Participants|||Count of Participants
1314288|NCT02452346|Primary|Over All Survival|Survival following treatment to the date of death, assessed up to a period of 3-4 years.|from start of treatment until death, assessed up to a period of 3-4 years.||||months||Full Range|Median
1314289|NCT02452320|Secondary|Hospital Costs|Accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital.|Costs incurred during hospital stay, expected average of 3 days.|Used the Hospital cost data for the subjects enrolled in both arms of the study for the duration of their hospitalization.|||Dollars (USD)||Inter-Quartile Range|Median
1314290|NCT02452320|Secondary|Length of Hospital Stay|Monitoring the length of hospital stay after undergoing surgery|Participants will be followed for the duration of hospital stay, expected average of 3 days.|Subjects LoS were recorded from time of PACU admission till time that Discharge Orders were completed.|||days||Inter-Quartile Range|Median
1314291|NCT02452320|Primary|Quality of Recovery-15 Patient Survey|Survey asking 15 questions with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Possible scores range from 0-150, and scores with a higher value indicate a better outcome. Each subject was administered a baselineQoR-15 survey prior to surgery, and then one on postoperative days (POD) 1 and 2. If a subject was discharged prior to POD2, they were not given a QoR-15 survey that day.|Patients will be followed for the duration of hospital stay, expected average of 3 days.|Subjects were administered a QoR-15 Survey pre-operatively as a baseline, and on post-operative days 1 and 2. Some subjects were discharged prior to the administration of the QoR-15 on post-operative day 2 and therefore there is no data for those subjects that we no longer in the hospital.|||units on a scale||Standard Deviation|Mean
1314292|NCT02451917|Other Pre-specified|Estimated Glomerular Filtration Rate (eGFR) Calculated by CKD-EPI|"Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is one of the most widely used IDMS traceable equations for estimating GFR in patients age 18 and over. CKD-EPI equation includes variables for age, gender, and race, which may allow providers to observe that CKD is present despite a serum creatinine concentration that appears to fall within or just above the normal reference interval.~CKD-EPI equation expressed as a single equation: GFR = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] where: Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males,min indicates the minimum of Scr /κ or 1, and max indicates the maximum of Scr /κ or 1."|baseline and 24 weeks||||ml/min/1.7m²||Standard Deviation|Mean
1314293|NCT02451917|Other Pre-specified|Serum Creatinine|Creatinine is measured in milligrams per deciliter of blood (mg/dL|baseline and 24 weeks|Creatinine endpoint was assessed using an analysis of covariance (ANOVA) model.|||mg/dL||Standard Deviation|Mean
1314294|NCT02451917|Other Pre-specified|Body Mass Index (BMI)|The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.|baseline and 24 weeks|BMI endpoint was assessed using an analysis of covariance (ANOVA) model.|||Kg/m²||Standard Deviation|Mean
1314295|NCT02451917|Other Pre-specified|Total Daily Insulin Dose|Daily total insulin dose at baseline compared to dose at week 24.|baseline and 24 weeks|Randomization was stratified by the A1c value at baseline: <9.0% or ≥9.0%, in a 1:1 ratio, and the individuals who met all inclusion-criteria were allocated alternately to either an IGlar/INPH or an INPH/IGlar treatment sequence.|||units/Kg/day||Standard Deviation|Mean
1314296|NCT02451917|Other Pre-specified|Glycemic Variability|In order to observe variability in interstitial glucose levels related to the therapy in use, participants wore a blinded CGM for 3 days. Changes in glycemic patterns were expressed by the average daily time spent in hypoglycemia (≤70 mg/dL or <3.9 mmol/L), hyperglycemia (>180 mg/dL or >10 mmol/L) and euglycemia (70-180 mg/dL or 3.9–10 mmol/L).|24 week|Patients were excluded from the analysis because of unfamiliarity with mechanical procedures related to the CGM use, visual impairment or technical problems with the sensor measurement.|||percentage of time||Standard Deviation|Mean
1314297|NCT02451917|Primary|Number of Hypoglycemic Events|Hypoglycemia was defined by capillary glycemia< 70 mg/dL (3.9 mmol/L), even if it was not accompanied by typical symptoms. Otherwise, hypoglycemia was classified as “severe” with SMBG below 50 mg/dL (2.8 mmol/L) or when it resulted in stupor, seizure, or unconsciousness that precluded self-treatment, thus requiring the assistance of another individual. Nocturnal events were defined as SMBG < 70mg/dL occurring after midnight and before wake-up in the morning (before 7:00am)12.|between 1rst and 24 weeks of each treatment arm|Endpoint hypoglycemia was assessed using an analysis of covariance (ANOVA) model|||events per patients during 24 weeks||Standard Deviation|Mean
1314298|NCT02451917|Primary|Difference in A1c Levels|A1c using high performance liquid chromatography measured in percentage|baseline and 24 weeks|Primary endpoint A1c was assessed using an analysis of covariance (ANOVA) model.|||percentage||Standard Deviation|Mean
1314299|NCT02451358|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine|"Solicited injection site reactions:~Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:>=50 mm)~Age >=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities [age 2-11 years], significant interference with daily activities [age >=12 years]; Erythema and Swelling >=50 mm [age 2-11 years], >100 mm [age >=12 years])~Solicited systemic reactions:~Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:>39.5 degree Celsius; Vomiting:>=6 episodes/24 hours; Crying abnormal:>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses >=3 feeds/meals or most feeds/meals; Irritability: inconsolable)~Age >=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)"|Within 7 days after any vaccination|Analysis was performed using Safety Analysis Set which included all participants who received at least 1 dose of study vaccine. Here, ‘Number Analyzed’ = those participants with available data for specified categories. 'Number analyzed' = 0 signifies that reported reaction was not analyzed in the specified age group.|||Participants|||Count of Participants
1314300|NCT02451358|Primary|Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <10 (1/dil) and post-vaccination titer >=40 (1/dil), and Significant increase was defined as pre-vaccination titer >=10 (1/dil) and >= 4-fold increase of post-vaccination titer.|28 days post-final vaccination (post-vaccination)|Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.|||Participants|||Count of Participants
1314301|NCT02451358|Primary|Number of Participants With Seroprotection to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer >=40 (1/dilution[dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.|||Participants|||Count of Participants
1314302|NCT02451358|Primary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1314303|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Laboratory Test Results|Laboratory test results are defined as serum chemistry, hematology and urinalysis.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
1314304|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Resting 12-Lead Electrocardiogram (ECG)|A resting 12-lead ECG was recorded. The investigator or subinvestigator (or a qualified physician at the study site) interpreted the ECG results.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
1314305|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Body Weight||Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
1314306|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Vital Signs|Vital signs are defined as sitting blood pressure, sitting pulse rate and temperature.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
1314307|NCT02451150|Primary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Up to 15 Days|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
1314308|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-II|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-II will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||percent of dose||Standard Deviation|Mean
1314309|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-I|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-I will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||percent of dose||Standard Deviation|Mean
1314596|NCT02444715|Primary|Change in LDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. LDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
1314314|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-II|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1314315|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1314316|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-I|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Standard Deviation|Mean
1314317|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-I|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Full Range|Median
1314318|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1314319|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-I|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1314320|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1314321|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan)|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Standard Deviation|Mean
1314322|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Full Range|Median
1314323|NCT02451150|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1314324|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1314325|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1314326|NCT02450799|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit|Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.|Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)|This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).|||logMAR||Standard Deviation|Mean
1314327|NCT02450747|Primary|Average Corneal Staining Area Grade|Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.|Baseline to 4- Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Average Percentage of Staining|Subject Eyes|Standard Deviation|Mean
1314328|NCT02450747|Primary|Upper Lid Margin Staining Score|Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||percentage of eyes|Subject Eyes||Number
1314329|NCT02450747|Primary|The Total Grade of Conjunctival Hyperemia|Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis is conducted on subject eyes.|||units on a scale|Subject Eyes|Standard Deviation|Mean
1314330|NCT02450591|Primary|Feasibility as Measured by at Least Five Patients Will Need to Complete Local Therapy.|At least five patients will need to complete local therapy within 2 years of the study being open to accrual for the primary endpoint to be met.|2 years|Primary outcome accrual goal was not achieved. Data were not collected.||||||
1314331|NCT02450539|Secondary|Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value|There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when ≥1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment*visit, and baseline score.Group-level negative change from baseline indicated group improvement.|Baseline to Measured Progressive Disease (Up To 6 Months)|All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).|||units on a scale||Standard Error|Least Squares Mean
1314332|NCT02450539|Secondary|Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score|The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment*visit, and baseline score. Group-level negative change from baseline indicated group improvement.|Baseline to Measured Progressive Disease (Up To 6 Months)|All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).|||units on a scale||Standard Error|Least Squares Mean
1314333|NCT02450539|Secondary|Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores|MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score–minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment*visit,and baseline score. Group-level negative change from baseline indicated group improvement.|Baseline through End of Study (Up To 6 Months)|All randomized participants for cycles which at least 25% of participants in each arm have a score.MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC assessment after Cycle 1 (for example, a completed MDASI-LC questionnaire at Cycle 2 Day 1 or later)|||units on a scale||Standard Error|Least Squares Mean
1314334|NCT02450539|Secondary|Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2|"Worsening of ECOG performance status is the duration from randomization to ECOG PFS of >/=2. Participants without an ECOG PFS >/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last).~The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead"|Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)|All randomized participants. Participants censored: Abemaciclib =93 and Docetaxel= 43.|||months||95% Confidence Interval|Median
1314348|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Integrity)|Outcome was measured by using a severity scale. No Atrophy=normal(0). Mild atrophy=vaginal surface bleeds with scraping(1). Moderate atrophy=vaginal surface bleeds with light contact(2). Severe atrophy=vaginal surface has petechiae before contact and bleeds with light contact(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
1314335|NCT02450539|Secondary|Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)|DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.|Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)|All randomized participants.|||percentage participants|||Number
1314336|NCT02450539|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.|Baseline to Objective Progression (Up To 6 Months)|All randomized participants.|||percentage participants|||Number
1314337|NCT02450539|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as the data inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|Baseline to Date of Death from Any Cause (Approximately 11 Months)||2019-07-31|07/2019||||
1314338|NCT02450539|Secondary|PK: Volume of Distribution of Abemaciclib|PK: Volume of Distribution of Abemaciclib|Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose|All participants who received Abemaciclib and had evaluable PK data.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1314339|NCT02450539|Secondary|Pharmacokinetics (PK): Clearance of Abemaciclib|Pharmacokinetics (PK): Clearance of Abemaciclib|Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose|All participants who received abemaciclib and had evaluable PK data.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1314340|NCT02450539|Primary|Progression Free Survival (PFS)|PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.|Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)|All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=19 and Docetaxel= 15.|||months||95% Confidence Interval|Median
1314341|NCT02450383|Secondary|Wound Healing, Measured Using a Standardized Visual Wound Healing Index|Wound healing status was evaluated by the same calibrated clinician using a standardized visual wound healing index at different time points A simple wound healing scoring system including 3 categories was used: 1- uneventful wound healing, 2- slight gingival edema, erythema or discomfort, 3- poor wound healing|2 weeks||||units on a scale||Standard Deviation|Mean
1314342|NCT02450383|Secondary|Patient-perceived Discomfort, Measured by VAS|Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded|2 weeks||||units on a scale||Standard Deviation|Mean
1314343|NCT02450383|Secondary|Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery||Baseline to 16 weeks after baseline||||millimeters||Standard Deviation|Mean
1314344|NCT02450383|Primary|Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery|Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points|Baseline and 16 weeks after baseline||||millimeters||Standard Deviation|Mean
1314345|NCT02449915|Primary|Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively|VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.|18 hours after surgery||||mm||Inter-Quartile Range|Median
1314346|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Secretions)|Outcome was measured by using a severity scale. No Atrophy has normal clear secretions noted on vaginal walls(0). Mild atrophy has superficial coating of secretions, difficulty with speculum insertion(1). Moderate atrophy is scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain(2). Severe atrophy has none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
1314347|NCT02449902|Primary|Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Surface Thickness)|Outcome was measured by using a severity scale. No Atrophy has rogation and elasticity of vault(0). Mild atrophy has poor rogation with some elasticity noted of vaginal vault(1). Moderate atrophy is smooth, some elasticity of vaginal vault(2). Severe atrophy is smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
1314914|NCT02434497|Secondary|Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline Non-HDL-C|participants|95% Confidence Interval|Geometric Mean
1314349|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Color)|Outcome was measured by using a severity scale. No Atrophy is pink in color (0). Mild atrophy is lighter in color (1). Moderate atrophy is pale in color (2). Severe atrophy is transparent, either no color or inflamed (3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
1314350|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.|Baseline to 15 days post-treatment|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.|||participants|||Number
1314351|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Severity of the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom|The severity of the most bothersome VVA symptom was self-assessed by each subject using a VVA questionnaire. The questionnaire has a 4-point scoring scale with: None=0, Mild=1, Moderate=2, and Severe=3. The lower the score, the least bothersome it is to the subject.|Baseline to 15 days post-treatment||||units on a scale||Standard Error|Least Squares Mean
1314352|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal pH||Baseline to 15 days post-treatment||||pH||Standard Error|Least Squares Mean
1314353|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Intermediate Cells)||Baseline to 15 days post-treatment||||Percentage of Intermediate Cells||Standard Error|Least Squares Mean
1314354|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Superficial Cells)||Baseline to 15 days post-treatment||||Percentage of Superficial Cells||Standard Error|Least Squares Mean
1314355|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)||Baseline to 15 days post-treatment||||Percentage of Parabasal Cells||Standard Error|Least Squares Mean
1314356|NCT02449798|Other Pre-specified|"Number of Attempts Prior to AccuCath 2.25 Use"|Count of catheter attempts during initial insertion before patient identified as difficult IV access|Number of IV attempts made before patient identified as difficult access and enrolled in study, could range from 3-30 minutes during initial procedure attempts||||number of attempts||Full Range|Median
1314357|NCT02449798|Secondary|Patient Satisfaction|A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.|at IV removal, which can be up to a maximum of 29 days||||units on a scale||Full Range|Median
1314358|NCT02449798|Secondary|Patient Satisfaction|A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.|At end of IV insertion, first 3-15 minutes of procedure||||units on a scale||Full Range|Median
1314359|NCT02449798|Secondary|Completion of Therapy|Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.|During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days||||Participants|||Count of Participants
1314360|NCT02449798|Secondary|Dwell Time|IV dwell time in hours until IV is no longer needed or complicates.|Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)|Admitted patients|||hours||Full Range|Median
1314361|NCT02449798|Secondary|Complications|Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site|During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days|The total number of complications resulting from all 120 IV placement procedures is reported.|||Complications|IV procedures||Number
1314362|NCT02449798|Secondary|Time to Catheter Placement|Time will be measured from initial vessel insertion through successful cannulation|At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes||||minutes||Full Range|Median
1314363|NCT02449798|Primary|Number of Catheter Attempts Required to Complete Successful PIV Placement||At IV insertion attempt, generally from 3-15 minutes||||Number of Catheters||Full Range|Median
1314364|NCT02449798|Primary|First Attempt Success Rate||At initial IV insertion attempt, generally from 3-15 minutes||||Participants|||Count of Participants
1314365|NCT02449356|Other Pre-specified|the Incidence of Dysphonia|count the number who suffered dysphonia within the first 24 hour after extubation|within the first 24 hour after extubation|all patients in both groups were analyzed|||Participants|||Count of Participants
1314366|NCT02449356|Other Pre-specified|the Incidence of Sore Throat|count the number who suffer sore throat within the first 24 hour after extubation|within the first 24 hour after extubation|all patients in both groups were analyzed|||Participants|||Count of Participants
1314367|NCT02449356|Other Pre-specified|the Incidence of Dysphagia|count the number who suffered the dysphagia within the first 24 hours after extubation|within the first 24 hours after extubation|all patients were analyzed|||Participants|||Count of Participants
1314368|NCT02449356|Secondary|the Degree of Loose or Dampness of the Tape|counting and quantifying the number who occured the dampness or loose of the tape in both groups|at the time when patients were turning to supine position|all participants in both groups were analyzed|||Participants|||Count of Participants
1314369|NCT02449356|Secondary|The Number of the Prolapse of Endotracheal Tube|Counting the number who occured the prolapse of endotracheal tube in both groups|At any time within the procedure of the whole surgery|All participants in both groups were analyzed|||Participants|||Count of Participants
1314370|NCT02449356|Primary|Displacement of the Endotracheal Tube|We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance＜0.5cm),moderate(0.5cm≤displacement distance＜1.5cm),severe (1.5cm≤displacement distance).|Participants were followed for the duration of surgery, an average of 2 hours.|All patients in each group were analyzed|||Participants|||Count of Participants
1314371|NCT02449044|Secondary|Change From Baseline in the Hyponatremia Disease-specific Survey|Analysis of individual items of Hyponatremia Disease-specific Survey was not conducted, because the analysis of Hyponatremia Disease-specific Survey was focused on the PCS and MCS summary scores since these 2 scores were developed. Subgroup analyses of Hyponatremia Disease-specific Survey were also not conducted.|Baseline to Week 214|The Hyponatremia Disease-specific Survey PCS and MCS scores evaluated during the trial were variable with only nominal changes from baseline observed. The data were collected under 2 different datasets, so the number of participants in each dataset was reduced that limited analysis of this endpoint.||||||
1314372|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS)|The MCS assess the physical and mental dimensions of health-related quality of life. The MCS is equal to the sum of the items of concentration activities, calculating activities, language activities, and memory activities. The MCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale’s publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||Units on a scale||Standard Deviation|Mean
1314373|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS)|The PCS assess the physical and mental dimensions of health-related quality of life. The PCS is equal to the sum of the items of endurance activities, strength activities, gross coordination activities, and fine coordination activities. The PCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale’s publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||Units on a scale||Standard Deviation|Mean
1314374|NCT02449044|Secondary|Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline|Body weight at each visit (assessed only for those with clinical evidence of hypervolemia at Baseline) and was summarized using descriptive statistics.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. The observed cases (OC) dataset consisted of only data points obtained from participants who were evaluated at the visit, without missing study drug consecutively for 14 days.|||kg||Standard Deviation|Mean
1314375|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Other Medicines|Percentage of participants requiring prescription of other medicines for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring other medicines such as demeclocycline or urea was not analyzed.|||percentage of participants|||Number
1314376|NCT02449044|Secondary|Number of Participants Requiring Prescription of Hypertonic Saline|Percentage of participants requiring prescription of hypertonic saline for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring prescription of hypertonic saline was not analyzed due to a low number of participants who received the treatment.|||participants|||Number
1314377|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Fluid Restriction|Percentage of participants requiring prescription of fluid restriction for the express purpose of treating hyponatremia during each period of the trial. Assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
1314378|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Normal Sodium Levels|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
1314379|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Mild Hyponatremia|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
1314415|NCT02448810|Secondary|Number of Participants With Incidence of Infusion Reactions After Imalumab Administration|Infusion reaction was defined as any relevant sign or symptom occurring during or after imalumab infusion and considered by the investigator as an infusion reaction.|From start of study drug administration up to EOT (approximately 21 Months)|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
1314380|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Severe Hyponatremia|Percentage of participants with varying degrees of hyponatremia (“severe” <130, “mild” 130-135, “normal” >135 mEq/L) at Baseline and each study visit.|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
1314381|NCT02449044|Secondary|Mean Change From Baseline in Serum Sodium Measurements|Sodium measurements obtained at designated intervals were compared to each participant's Baseline sodium level at the beginning of placebo-controlled therapy in their original trial and from Baseline on initiation of therapy in the open-label trial.|Baseline of parent trial to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||mEq/L||Standard Deviation|Mean
1314382|NCT02449044|Primary|Participants With Body Weight Abnormalities Reported as TEAEs|The body weight evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Every effort was made to ensure that body weight measurements were performed in a reproducible and consistent manner. The pre-defined criteria was change of ≥7% in body weight for both male and female. Participants were to wear the same type of clothes at each measurement, preferably a gown and no shoes. All body weight measurements were to have been taken post-void.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
1314383|NCT02449044|Primary|Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Criteria for identifying vital signs of potential clinical relevance included: Heart rate, supine: >= 120 beats per minute (bpm) + increase of ≥15 bpm from Baseline and <=50 bpm + decrease of >= 15 bpm; Diastolic Blood Pressure, Supine: >=105 mmHg + increase of >=15 mmHg and <=50 mmHg + decrease of >=15 mmHg; Systolic Blood Pressure, Supine: >=180 mmHg + increase of >=20 mmHg and <= 90 mmHg + decrease of >=20 mmHg; Temperature (degree C): Increase of >=1.1 to >=38.3C. The vital sign abnormalities were reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The intent-to-treat (ITT) dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
1314384|NCT02449044|Primary|Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs|The ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in HR outliers, PR outliers, QRS outliers, QT, QTcB, QTcF that were identified based on pre-defined criteria. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: For QTcB and QTcF: baseline mean of QTcB and QTcF interval was new onset >500 msec, 30 - 60 msec, >60 msec; For QT: new onset >500 msec; For QRS outliers: >=25% change from baseline when QRS >100 msec; PR outliers: >=25% change from baseline when PR>200 msec; HR outliers: 25% decrease from baseline and HR <50 bpm or 25% increase from baseline and HR >100 bpm. New onset (>500 msec) in QT, QTcB, or QTcF means a participant who attained a value >500 msec during treatment period but not at each baseline visit. The ECG-related abnormalities are reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
1314385|NCT02449044|Primary|Participants With Laboratory Values Abnormalities Reported as TEAEs|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant for identifying laboratory values of potential clinical relevance. Participants noted with abnormal laboratory values are reported below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
1314386|NCT02449044|Primary|Participants With Adverse Events (AEs)|A TEAE was an AE that began after the first injection or was continuous from Baseline and was defined as any new medical problem, or exacerbation of an existing problem, whether or not it was considered drug-related by the study physician. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-subject hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent the outcomes mentioned above.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
1314387|NCT02449018|Secondary|Plasma Concentration of QBW251 by AUC0-12h|AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.|Day 1, Day 28|PK analysis set: included all patients with at least one available valid PK concentration measurement. Due to practicalities of study conduct PK samples were collected only up to 8 hours. As a result, from noncompartmental analysis AUClast was not calculated up to 12 hours after dosing So this data is not available.||||||
1314416|NCT02448810|Secondary|Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies|Number of participants with occurrence of binding and/or neutralizing anti-imalumab antibodies were reported.|From start of study drug administration up to end of treatment (EOT) (approximately 21 Months)|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
1314388|NCT02449018|Secondary|Plasma Concentration of QBW251 by AUClast (0-8hours)|AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.|Day 1, Day 28|Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28|||hr×ng/mL||Standard Deviation|Mean
1314389|NCT02449018|Secondary|Plasma Concentration of QBW251 by CMax (0-8hours)|Cmax is the observed maximum plasma concentration following drug administration.|Day 1, Day 28|Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28|||ng/mL||Standard Deviation|Mean
1314390|NCT02449018|Secondary|Plasma Concentration of QBW251 by TMax (0-8hours)|Tmax is the time to reach the maximum concentration after drug administration.|Day 1, Day 28|Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28|||hr||Full Range|Median
1314391|NCT02449018|Secondary|Change From Baseline in DLCO|Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data|||ml/min/mmHg||Standard Error|Least Squares Mean
1314392|NCT02449018|Secondary|Change From Baseline in FRC|Change From Baseline to Day 29 in FRC will be measured by spirometry. Functional residual capacity (FRC) is the volume in the lungs at the end-expiratory position. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data|||Liters||Standard Deviation|Least Squares Mean
1314393|NCT02449018|Secondary|Change From Baseline in RV|Change From Baseline to Day 29 in RV will be measured by spirometry. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data|||Liters||Standard Deviation|Least Squares Mean
1314394|NCT02449018|Secondary|Change From Baseline in TLC|Change From Baseline to Day 29 in TLC will be measured by spirometry. Total lung capacity (TLC) is the volume in the lungs at maximal inflation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Least Squares Mean
1314395|NCT02449018|Secondary|Change From Baseline in FVC Post- Bronchodilator|Change From Baseline to Day 29 in FVC will be measured by spirometer after bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Least Squares Mean
1314396|NCT02449018|Secondary|Change From Baseline in FVC Pre Bronchodilator|Change From Baseline to Day 29 in FVC will be measured by spirometer before bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Least Squares Mean
1314397|NCT02449018|Secondary|Change From Baseline in FEV1 Post-bronchodilator|Change From Baseline to Day 29 in FEV1 will be measured by spirometer after bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Mean
1314398|NCT02449018|Secondary|Change From Baseline in FEV1 Pre-bronchodilator|Change From Baseline to Day 29 in FEV1 will be measured by spirometer before bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Mean
1314399|NCT02449018|Primary|Change From Baseline in Lung Clearance Index (LCI)|Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.|Baseline and Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Days||Standard Deviation|Mean
1314430|NCT02448368|Secondary|Incidence of Treatment-Emergent Adverse Events||8 weeks|The safety population included all participants who received any dose of investigational product.|||Number of participants|||Number
1317277|NCT02368314|Secondary|Frequency of DTV|Frequency of DTV (proximal and/or distal; symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
1314400|NCT02448914|Other Pre-specified|Treatment Response Scale (ON/OFF Effect) - Mean % of Time Patients Were in Functional ON State During 3-14 h|Dyskinesia and parkinsonism symptoms were evaluated throughout the study period as an assessment of the clinical response. To assess the ON/OFF effect the Treatment Response Scale (TRS) was used. The TRS ranges from -3 (severe “OFF”) to +3 (“ON” with severe dyskinesia). Results from the TRS recordings are presented as the mean percentage of time patients were in functional ON state (TRS: -1 to +1) during the time interval 3-14 h.|TRS assessments were made every 30 minutes from start of study drug administration until 3 h, every hour between 3 and 14 h and every 30 minutes between 14 and 17 h.||||Mean % of time||Full Range|Mean
1314401|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for 3-O-Methyldopa||During 14 h infusion on 2 consecutive days||||h*ng/mL/mg||Full Range|Least Squares Mean
1314402|NCT02448914|Secondary|Number of Adverse Events||Patients will be followed for the duration of the hospital stay, an expected average of 3 days||||adverse events|||Number
1314403|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for Carbidopa||During 14 h infusion on 2 consecutive days||||h*ng/mL/mg||Full Range|Least Squares Mean
1314404|NCT02448914|Secondary|Intra-individual Coefficient of Variation (3-14h) for Levodopa|The individual patient’s coefficient of variation (CV) of levodopa plasma concentration during administration of TRIGEL and Duodopa respectively between 3 and 14 h after start of study drug. CV=100*sqrt (exp (SDlog*SDlog)-1) were SDlog denotes the standard deviation computed on logged plasma concentrations.|During 3-14h infusion on 2 consecutive days||||percentage of variability||Full Range|Least Squares Mean
1314405|NCT02448914|Primary|Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa||During 14 h infusion on 2 consecutive days||||h*ng/mL/mg||Full Range|Least Squares Mean
1314406|NCT02448862|Secondary|Incidence of Dizziness or Headaches|The percentage of participants who had headache and dizziness|Postoperative 48 hours||||percentage of participants|||Number
1314407|NCT02448862|Secondary|Incidence of Nausea and Vomiting|The percentage of participants who had nausea and vomiting during postoperative 48 hours|Postoperative 48 hours||||percentage of participants|||Number
1314408|NCT02448862|Secondary|Postoperative Pain in Numeric Pain Scale|The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0~6, 6~12, 12~18, 18~24, 24~48 hours)|Postoperative 48 hours||||Scores on a scale||Standard Deviation|Mean
1314409|NCT02448862|Primary|Incidence of Rescue Antiemetics Requirement|The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period|Postoperative 48 hours||||Percentage of Participants|||Number
1314410|NCT02448862|Primary|Incidence of Rescue Analgesics Requirement|The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period|Postoperative 48 hours||||Percentage of Participants|||Number
1314411|NCT02448810|Secondary|Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30 was a validated instrument used to measure QoL and assess symptoms and side effects of treatment and the impact on everyday life.The QLQ-C30 was composed of: A) 5 multi-item functioning scales(physical, role, social, emotional and cognitive), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a higher level of functioning and a better QoL. B) A global health status/QoL scale that was answered on a 7-point scale (1=Very Poor to 7=Excellent). Each score range from 0 to 100 with a higher score representing a better QoL. C) 9 symptom scales(fatigue, nausea/vomiting,pain,financial impact/difficulties,appetite loss,diarrhea, constipation,sleep disturbance/insomnia and dyspnea), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a greater degree of symptoms and a worse QoL.|Baseline, 21 Months (EOT) up to follow-up|SAS included all participants who received at least 1 administration of study drug.|||score on a scale||Standard Deviation|Mean
1314412|NCT02448810|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death due to any cause. Here, number of participants analyzed was based on the number of participants who underwent death.|From start of study drug administration up to EOT (approximately 21 Months)|FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.|||weeks||95% Confidence Interval|Median
1314413|NCT02448810|Secondary|Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Number of participants with response evaluation according to RECIST v1.1 was evaluated according to complete response (CR): disappearance of all target and non-target lesions and no new lesions; partial response (PR): >= 30 percent (%) decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; stable disease (SD): neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; progressive disease (PD): >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5 millimeter (mm) (compared to the previous minimum sum) or progression of a new lesion.|Day 28 of Cycle 2 followed by every 2 Cycles of 28 day Cycles: Day 56, Day 112, Day 168 and Day 224|FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.|||Participants|||Count of Participants
1314414|NCT02448810|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. TEAEs was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.|From start of study drug administration up to EOT (approximately 21 Months)|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
1317518|NCT02361736|Primary|Concentration of NGAL in Plasma on 5 Time Point.|concentration of NGAL in plasma on 5 time point. Biomarkers are measured by ELISA.|-1d, 0d, 1d, 3d, 5d after surgery||||ng/ml||Standard Deviation|Mean
1314417|NCT02448810|Primary|Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT)|DLT was defined as any drug-related treatment-emergent adverse event (TEAE) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03) that occurs during the first 28 days after treatment start and that meets any of the following criteria: i) Any >= Grade 3 non-hematologic toxicity (excluding: mucositis/stomatitis of Grade 3; diarrhea of <3 days duration; nausea and vomiting <3 days duration; fatigue of <7 days duration; alopecia; single laboratory value out of the normal range that has no clinical significance and that resolves to <= Grade 2 with adequate measures within 7 days) ii) Any Grade 4 hematologic toxicity (excluding: grade 4 neutropenia lasting for <= 5 days; isolated grade 4 lymphocytopenia) iii) Grade 3 febrile neutropenia iv) Grade 3 thrombocytopenia associated with bleeding v) Any life-threatening complication or abnormality not covered in NCI CTCAEv4.03.|From start of study treatment up to 28 days|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
1314418|NCT02448810|Primary|Part 2: Progression-Free Survival (PFS)|PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent.|From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression|Full analysis set (FAS) included all participants who received at least 1 administration of study drug, and who had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.|||weeks||95% Confidence Interval|Median
1314419|NCT02448563|Secondary|Waist Circumference at 8 Weeks||8 weeks||||centimeters||Standard Deviation|Mean
1314420|NCT02448563|Secondary|Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale|Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score – baseline score).|Baseline and 8 weeks||||units on a scale||Standard Error|Mean
1314421|NCT02448563|Secondary|Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire|The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score – Baseline score). Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome. A positive value shows improvement in that subscale over time.|Baseline and 8 weeks||||units on a scale||Standard Error|Mean
1314422|NCT02448563|Secondary|Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire|Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score – Baseline score).|Baseline and 8 weeks||||z-score||Standard Error|Mean
1314423|NCT02448563|Secondary|Participant Satisfaction as Measured by Questionnaire and Exit Interview||8 weeks||||Percentage|||Number
1314424|NCT02448563|Secondary|Change From Baseline Weight to 8 Weeks||Baseline and 8 weeks||||kilograms||Standard Error|Mean
1314425|NCT02448563|Primary|Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)||Weekly up to 8 weeks||||participants|||Number
1314426|NCT02448537|Secondary|Treatment Related Serious Adverse Events|Summary of the serious adverse events (SAE) experienced by participants that were deemed to be at least possibly related to PM01183 when administered alone or with Doxorubicin or Gemcitabine. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v4).|From the start of treatment until 30 days after the end of treatment||||participants|||Number
1314427|NCT02448537|Secondary|Overall Survival Rate|Overall survival is measured as the median duration of time from the start of treatment until the time of death.|from the start of treatment until death||2022-02-28|02/2022||||
1314428|NCT02448537|Secondary|Overall Response Rate|"The overall response rate is the number of participants that achieved either Stable Disease (SD), a Partial Response (PR), or a Complete Response (CR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The overall response rate is the best response recorded from the start of treatment until disease progression/recurrence.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 6 weeks for the first 8 cycles (cycle is 21 days) and then every 9 weeks thereafter until disease progression||||Participants|||Count of Participants
1314429|NCT02448537|Primary|Disease Control Rate|"The number of participants that achieved either Stable Disease (SD) or a Partial Response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) at 24 weeks.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|24 Weeks|Two participants (one from the PM01183 and Doxorubicin arm and one from the PM01183 alone arm) were not able to be evaluated for response.|||Participants|||Count of Participants
1314431|NCT02448368|Secondary|Pharmacodynamics (PD) Profile of RDEA3170|Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.|Day -1, 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 (but not from pharmacodynamics analysis) following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||Percent (%) Change||Standard Error|Mean
1314432|NCT02448368|Primary|AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules|AUC 0-∞ is a meausre of total concentration from time zero to infinity|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
1314433|NCT02448368|Primary|AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules|AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
1314434|NCT02448368|Primary|Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules|Cmax is the maximum observed concentration of a drug after administration|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng/mL||95% Confidence Interval|Geometric Mean
1314435|NCT02448368|Primary|Apparent Terminal Half-life (t1/2)|t1/2 is a measure of apparent terminal half-life|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||hr||95% Confidence Interval|Geometric Mean
1314436|NCT02448368|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)|AUC 0-∞ is a meausre of total concentration from time zero to infinity|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
1314437|NCT02448368|Primary|Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)|AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
1314438|NCT02448368|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax is the time of occurrence of cmax|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||hr||Full Range|Median
1314439|NCT02448368|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax is the maximum observed concentration of a drug after administration|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng/mL||95% Confidence Interval|Geometric Mean
1314440|NCT02447848|Secondary|PI at Each Evaluation Time Point|Pain intensity at each evaluation time point after the first dose of study drug up through 5 hours is evaluated using an 11-point NRS where 0 equals no pain and 10 equals worst possible pain. The score was obtained at Baseline, 15- , 30-, 45- minutes, 1-hour, and 2-hours after the first dose for all patients, and at hours 3, 4, and 5 for cohort 2 (patients 41-76). Scores ranged from 0 -10 for the first two hours, and 2 - 10 for hours three to five.|5 hours|The first cohort of patients (N=40) received one dose of study drug and the study was completed at two hours. The second cohort of patients (N=36) had the option of remaining in the study through five hours; most patients discontinued the study at 2 hours.|||units on a scale||Standard Error|Mean
1314441|NCT02447848|Secondary|TOTPAR1 (Time-weighted)|"The total pain relief (TOTPAR) is the time-weighted sum of the pain relief scores over the first hour (15 minutes, 30 minutes, 45 minutes and 1-hour after the first dose of study drug is taken) of the study period.~The minimum score is 0.00 and the maximum score is 4.00. A higher score indicates greater pain relief."|1-hour||||units on a scale||Standard Error|Mean
1314442|NCT02447848|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).|"The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain).~The patient’s rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug.~The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity [PID (evaluation time after the first dose) = PI(baseline) – PI(evaluation time after the first dose)]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period.~The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity."|One hour||||units on a scale||Standard Error|Mean
1314444|NCT02447458|Secondary|Fe: Fraction of MLN3126 Excreted in the Urine|Fe is the Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.|||Percentage||Standard Deviation|Mean
1314445|NCT02447458|Secondary|Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine|Ae (0-96) is the total amount of drug excreted in urine from time 0 to time 96 hours.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.|||ng||Standard Deviation|Mean
1314446|NCT02447458|Secondary|T ½: Half-life of MLN3126 and Metabolite M-I|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||Hours||Standard Deviation|Mean
1314447|NCT02447458|Secondary|CL/F: Oral Clearance of MLN3126|CL/F is apparent clearance of the drug from the plasma, after extravascular administration.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||L/hr||Standard Deviation|Mean
1314448|NCT02447458|Secondary|AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity|AUC(0-inf) is measure of area under the curve from time 0 to infinity.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1314449|NCT02447458|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1314450|NCT02447458|Secondary|Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Tmax is the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||Hours||Full Range|Median
1314451|NCT02447458|Secondary|Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|Pharmacokinetic (PK) analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||ng/mL||Standard Deviation|Mean
1314452|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1314453|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose|Vital signs included oral body temperature measurement, blood pressure, respiration rate, and pulse rate [beats per minute (bpm) or heart rate]. The percentage of participant with markedly abnormal vital signs findings during the study. OBP=Orthostatic Blood Pressure. All OBP measurements were standing.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1314454|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose|Clinical safety laboratory tests included clinical chemistry, hematology and urinalysis. The percentage of participants with any markedly abnormal laboratory finding during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1314455|NCT02447458|Primary|Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 22|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Number
1314456|NCT02447432|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Day 0 to Month 9|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.|||Participants|||Count of Participants
1314457|NCT02447432|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Month 0 to Month 4|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.|||Participants|||Count of Participants
1314458|NCT02447432|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.|||Participants|||Count of Participants
1314459|NCT02447432|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.|||Participants|||Count of Participants
1314460|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002)|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (>) 39.5°C.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.|||Participants|||Count of Participants
1314461|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001)|"Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.~Dose 4 = 10Pn-PD-DIT at 18 weeks of age."|Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine|The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
1314462|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002)|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.|||Participants|||Count of Participants
1314463|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001)|"Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.~Dose 4 = 10Pn-PD-DIT at 18 weeks of age."|Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine|The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
1314464|NCT02447432|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1314597|NCT02444715|Primary|Change in HDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
1314465|NCT02447432|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1314466|NCT02447432|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002)|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1314467|NCT02447432|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001)|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1314468|NCT02447432|Secondary|Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002)|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1314469|NCT02447432|Primary|Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1314470|NCT02447328|Primary|Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)|Percentage of patients with AEs.|The median duration of Fulvestrant (Faslodex) treatment was analysed with 95% CI. The median treatment duration was 60 days (8.57 weeks) with 95%CI between 57 and 136 days (8.14, 19.43 weeks) throughout the study.||||Percentage of participants||95% Confidence Interval|Number
1314471|NCT02447133|Primary|TopQ Cut Off|To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.|1 hour|use of 12 subjects for 3 different scan patterns|||microns|||Number
1314472|NCT02447029|Secondary|Overall Complication Rate as Measured by a Count of Participants in Each Group||Rate of complications at the end of the study|All treated patients were analyzed|||Participants|||Count of Participants
1314473|NCT02447029|Secondary|Overall Satisfaction With Procedure as Measured by a Visual Analog Scale|This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.|30-45 minutes after completion of procedure|All treated patients were included in the analysis|||units on a scale||Inter-Quartile Range|Median
1314474|NCT02447029|Secondary|Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain prior to discharge home: 30-45 minutes after completion of procedure|All treated patients were included in the analysis|||units on a scale||Inter-Quartile Range|Median
1314475|NCT02447029|Secondary|Pain With Tenaculum Placement as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain at time of tenaculum placement|All treated patients were included in the analysis|||units on a scale||Standard Deviation|Mean
1319138|NCT02320838|Primary|Tactile Threshold During Treatment|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|during treatment at 15 min.||||mN||Standard Deviation|Mean
1314476|NCT02447029|Secondary|Pain With Speculum Insertion as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain at time of speculum insertion|Treated patients were included in the analysis|||units on a scale||Standard Deviation|Mean
1314477|NCT02447029|Secondary|Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain level prior to procedure|Treated patients were included in the analysis|||units on a scale||Inter-Quartile Range|Median
1314478|NCT02447029|Primary|Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|At time of cervical dilation, 30 minutes after lidocaine administration|Treated participants were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1314479|NCT02446990|Secondary|Secondary Composite Endpoint|Non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314480|NCT02446990|Secondary|Secondary Composite Endpoint|Coronary death, non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314481|NCT02446990|Secondary|Secondary Composite Endpoint|Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314482|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314483|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314484|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314485|NCT02446990|Secondary|Coronary Revascularisation (Elective or Not)|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314486|NCT02446990|Secondary|Elective Coronary Revascularisation|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314487|NCT02446990|Secondary|Non-fatal Myocardial Infarction|Component of the primary composite endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
1314488|NCT02446990|Secondary|Fatal Myocardial Infarction|Non-composite secondary endpoint|From the date of randomisation to death, up to 48 months||||participants|||Number
1314489|NCT02446990|Secondary|Coronary Mortality|Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death|From the date of randomisation to death, up to 48 months||||participants|||Number
1314490|NCT02446990|Secondary|Cardiovascular Mortality|Component of the primary composite endpoint|From the date of randomisation to death, up to 48 months||||participants|||Number
1314491|NCT02446990|Secondary|All-cause Mortality||From the date of randomisation to death, up to 48 months||||participants|||Number
1314492|NCT02446990|Primary|Primary Composite Endpoint|First event among cardiovascular death or non-fatal myocardial infarction|The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.||||participants|||Number
1314493|NCT02446743|Secondary|Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination|"The percentage of subjects with 4-fold rise at one month post-vaccination with a second dose (naïve subjects) of rMenB+OMV NZ with respect to day 1, to each and any one, two, three or all 4 indicator strains.~Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as:~for a pre-vaccination titer < 4, a post-vaccination titer of at least 16;~for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ;~for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.~Only subjects receiving the second dose of vaccination(group B_0_1) were considered for this outcome measure."|At Day 61 (30 days post second dose of vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Percentage of Subjects||95% Confidence Interval|Number
1314494|NCT02446743|Secondary|Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 1 & Day 61 (30 days post 2nd vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Ratio||95% Confidence Interval|Geometric Mean
1314495|NCT02446743|Secondary|hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 1 & Day 61 (30 days post second dose of vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Titers||95% Confidence Interval|Geometric Mean
1314496|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 61 (30 days post second vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314497|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 61 (30 days post second vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314498|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.|At Day 61 (30 days post second dose of vaccination.)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314499|NCT02446743|Secondary|Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination|The percentage of subjects with 4-fold rise at 3, 7, 30 days post-vaccination with a booster dose (follow-on subjects) /second dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-second dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.|Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34/38 & 61(naive)|||Percentage of subjects||95% Confidence Interval|Number
1314500|NCT02446743|Secondary|Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination.|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs post-vaccination with a booster dose (Group 3B) versus pre-booster dose or second dose (Group B_0_1) of vaccination versus pre second dose.|Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Ratio||95% Confidence Interval|Geometric Mean
1314501|NCT02446743|Secondary|hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose."|Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose.|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Titers||95% Confidence Interval|Geometric Mean
1314502|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose"|Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Percentage of subjects||95% Confidence Interval|Number
1314511|NCT02446743|Primary|Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs.|A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity.|Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit)|Analysis was performed on the Overall safety set. The overall safety set included all screened subjects in the solicited and unsolicited safety set who provided informed consent and provided demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study and received a Subject ID.|||Subjects|||Number
1314503|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose."|Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Percentage of subjects||95% Confidence Interval|Number
1314504|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose."|"Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose."|Analysis was performed on the PPS kinetics which included all subjects who correctly received the vaccination at day 1/ day 1 & day 31 (naive subjects) & provided evaluable immunogenicity result at all of days 4, 8 & 31 (for follow-on subjects) or at all of days 34,38 and 61 (naive subjects).|||Percentage of subjects||95% Confidence Interval|Number
1314505|NCT02446743|Secondary|Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination|The percentage of subjects with 4-fold rise at one month post-vaccination with a booster dose (follow-on subjects) /first dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-first dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer|Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination|Analysis was performed on the Full Analysis set (FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for atleast one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314506|NCT02446743|Secondary|Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1.|Bactericidal activity was measured against each of the fout N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose of rMenB+OMV NZ versus prefirst dose (naïve subjects) to each N. meningitidis group B indicator strain.|At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination).|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Ratio||95% Confidence Interval|Geometric Mean
1314507|NCT02446743|Secondary|hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination.|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.|Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Titers||95% Confidence Interval|Geometric Mean
1314508|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99, NZ98/254 & M10713.|Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314509|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.|Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314510|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ.|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.|Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314598|NCT02444715|Primary|Change in Systolic Blood Pressure||baseline and 6 months|Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.|||mmHg||Standard Deviation|Mean
1314915|NCT02434497|Secondary|Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline TG|participants|95% Confidence Interval|Geometric Mean
1314512|NCT02446743|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B_0_1 subjects.|30 days (including the day of vaccination) after each vaccination.|Analysis was performed on the unsolicited safety set. The unsolicited safety set included all subjects who received a study vaccination with unsolicited adverse event data.|||Subjects|||Number
1314513|NCT02446743|Primary|Number of Subjects With Solicited Local and Systemic AEs.|Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: >= 25 mm Note:Vaccination 2 was performed only on group B_0_1 subjects. Threshold for any Erythema, Swelling and Induration: >= 25 mm|7 days (including the day of vaccination) after each vaccination|The analysis was done on the Solicited Safety Set. The solicited safety set included all subjects in the exposed set with any solicited adverse event data and/indicators of solicited adverse events.|||Subjects|||Number
1314514|NCT02446743|Primary|Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1.|The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.|Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose)|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Ratio||95% Confidence Interval|Geometric Mean
1314515|NCT02446743|Primary|hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study.|Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.|Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose)|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Titers||95% Confidence Interval|Geometric Mean
1314516|NCT02446743|Primary|Percentage of Subjects With hSBA≥1:16|Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713|Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314517|NCT02446743|Primary|Percentage of Subjects With hSBA≥1:8|Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713|Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314518|NCT02446743|Primary|Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) ≥1:5|Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99, NZ98/254 a nd M10713|Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
1314519|NCT02446717|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1314520|NCT02446717|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Day 3, Treatment Weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment for 12-week treatment arms), and 16 (end of treatment for 16-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population)|||percentage of participants||95% Confidence Interval|Number
1314521|NCT02446717|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)|SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1314522|NCT02446717|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1329598|NCT02107014|Primary|Change in MIP-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1314523|NCT02446613|Secondary|Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.|Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Score on a scale||Standard Deviation|Mean
1314524|NCT02446613|Primary|Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Percent change||95% Confidence Interval|Median
1314525|NCT02446613|Primary|Percent Change From Baseline in the PNIF up to Post-NAC 6 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety populaton|||Percent change||95% Confidence Interval|Median
1314526|NCT02446613|Primary|Percent Change From Baseline in the PNIF Over Post-NAC 1 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] to post-NAC 1 h)|Safety population|||Percent change||95% Confidence Interval|Median
1314527|NCT02446613|Primary|Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min|PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] and post-NAC 15 min)|Safety population|||Percent change||95% Confidence Interval|Median
1314528|NCT02446613|Primary|Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h|TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Score on a scale||95% Confidence Interval|Median
1314529|NCT02446613|Primary|Mean Change From Baseline in the TNSS Over Post-NAC 6 h|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Score on a scale||95% Confidence Interval|Median
1314546|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs of Supine Systolic and Diastolic Blood Pressure.|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: Systolic Blood Pressure (SBP) and Diastolic BP. The measurement of vital signs for SBP and DBP are presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||mmHg||Standard Deviation|Mean
1329599|NCT02107014|Primary|Change in GM-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1314530|NCT02446613|Primary|Mean Change From Baseline in the TNSS Over Post-NAC 1 h|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported.|Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)|Safety population|||Score on a scale||95% Confidence Interval|Median
1314531|NCT02446613|Primary|Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value.|Day 1 (Baseline [pre-NAC] and post-NAC 15 min)|The Safety population consisted of members of the ASP of parent study TL7116958 who had passed screening for study 204509.|||Score on a scale||95% Confidence Interval|Median
1314532|NCT02446496|Secondary|Apparent First-order Elimination or Terminal Rate Constant (Ke)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.|||Per hour||Standard Deviation|Mean
1314533|NCT02446496|Secondary|Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.|||Hour||Full Range|Median
1314534|NCT02446496|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Area under the plasma concentration-time curve from time zero (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method. Area under the plasma concentration-time curve from time zero (0) to infinity (AUC0-infinity) was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant (Ke), where first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.|||Microgram.hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1314535|NCT02446496|Primary|Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population: who were crossed over and completed the balance design, were included in the calculation. All participants were present at the time of measurement.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1314536|NCT02446483|Secondary|Apparent First-order Elimination or Terminal Rate Constant|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period|All subject population. Data is presented for the participants available at the time of assessment.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
1314537|NCT02446483|Secondary|Time of the Maximum Plasma Concentration (T-max) and Terminal Half-life (T-half)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with b obtained as the slope of the linear regression of the logarithmically transformed plasma concentrations versus time in the terminal period of the plasma curve.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All Subject Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
1314538|NCT02446483|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All subject population. Only those participants available at the specified time points were analyzed.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1314539|NCT02446483|Primary|Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Least Squares Geometric Means with respective Geometric Coefficient of Variation (% CV).|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All subject population comprised of all participants who were crossed over and completed the balance design, were included in the calculation.|||Nanogram per mL (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1314540|NCT02446171|Secondary|Taste Test Assessment.|A standardized questionnaire was provided to participants and were asked to complete the questionnaire for the liquid formulations tested, i.e., Naloxegol crushed tablet, oral (Treatment A) and Naloxegol oral solution (Treatment C), without assistance or influence from site personnel. For each formulation, the questionnaire was identical and required the participant's opinion. Sweet, salty, sour, bitter, metallic, hot/spicy were rated on a scale of 0 to 10, where 0 means not at all and 10 means extreme. The overall rating of the taste was rated on a scale of 0 to 10, where 0 means “I dislike it extremely much” and 10 means “I like it extremely much”. The smell of the medicine was based on a scale of 0 to 10, where 0 means extremely bad and 10 means extremely nice. The question on whether the participants would consider ever taking the medicine again was based on a scale of 0 to 10, where 0 means “Never – under no circumstances” and 10 means “Yes, definitely”.|Within 1 hour after dosing (Treatments A and C only).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||units on a scale||Full Range|Median
1314541|NCT02446171|Secondary|Participants With Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening and at the final follow-up visit (maximum 9 weeks apart); in addition, for the first and third treatment period at pre-dose.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
1314542|NCT02446171|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening, first admission to the clinical unit (Visit 2, Day -1), 1.25 hours after each dose (Visits 2-5, Day 1), as well as at the final follow-up visit (up to 9 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
1314543|NCT02446171|Secondary|Participants With Significant Findings in Columbia-Suicide Severity Rating Scale (C-SSRS).|The C-SSRS is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events, and provided a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation and deterrents), all of which are significantly predictive of completed suicide. The C-SSRS was performed to determine the presence of suicidality.|At Baseline and Days 1-4 of each treatment period.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
1314544|NCT02446171|Secondary|Participants With Significant Findings in Physical Examination.|A complete physical examination included an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, mouth and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. Physical examination was performed to check for any significant abnormality in participants.|A full physical examination at screening and the final follow-up visit (maximum 9 weeks apart). Abbreviated physical examination on admission (on Day -1 of each treatment period) and at 48-hours post-dose to each treatment period (for up to 4 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
1314545|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Pulse rate: the measurement of vital signs for pulse rate is presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||beats per minute (bpm)||Standard Deviation|Mean
1314589|NCT02444715|Secondary|Change in Sweets Consumption|"Self-reported weekly portions of sweets consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of sweets and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on sweets consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||portions||Inter-Quartile Range|Median
1314547|NCT02446171|Secondary|Percentage of Participants With Adverse Events (AE).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.The term AE is used generally to include any AE whether serious or non-serious. An serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|For up to 9 weeks (starting with screening).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||percentage of participants|||Number
1314548|NCT02446171|Secondary|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F).|This was one of the PK parameters to determine the apparent volume of distribution during the terminal phase after extravascular administration.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||L||Geometric Coefficient of Variation|Geometric Mean
1314549|NCT02446171|Secondary|Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F).|This was one of the PK parameters to determine the apparent total body clearance after extravascular administration estimated as dose divided by AUC. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1314550|NCT02446171|Secondary|Mean Residence Time (MRT).|This was one of the PK parameters to determine MRT. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h||Standard Deviation|Mean
1314551|NCT02446171|Secondary|Mean Dissolution Time (MDT).|This was one of the PK parameters to determine MDT (whole tablet only) (calculated as MRT Treatment D [Reference] - MRT Treatment C [Test]). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point. There were zero participants analyzed in Treatment A, B and C, hence data was not determined.|||h||Standard Deviation|Mean
1314552|NCT02446171|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz).|This was one of the PK parameters to determine λz of a t½λz. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h||Standard Deviation|Mean
1314553|NCT02446171|Secondary|Time to Reach Maximum Plasma Concentration (Tmax).|This was one of the PK parameters to determine the time to reach maximum plasma concentration (tmax). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h||Full Range|Median
1314554|NCT02446171|Primary|Observed Maximum Plasma Concentration (Cmax).|Observed maximum plasma concentration (Cmax) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314590|NCT02444715|Secondary|Change in Whole Grain Food Consumption|"Self-reported weekly portions of whole grain food consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of whole grain food and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on whole grain food consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||portions||Inter-Quartile Range|Median
1314555|NCT02446171|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC 0-t).|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314556|NCT02446171|Primary|Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-infinity).|Area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to administration of the investigational medicinal product (IMP)]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The Pharmacokinetic (PK) analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314557|NCT02446015|Secondary|Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
1314558|NCT02446015|Secondary|Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28|The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
1314559|NCT02446015|Primary|Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28|"The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is Absent and 5 is Severe. The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses."|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
1314560|NCT02445807|Secondary|The Percentage of Subjects With Treatment Success at the Day 8 Visit.|"The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8.~The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets."|At Day 8 Visit||||percentage of participants|||Number
1314561|NCT02445807|Secondary|The Percent Change in Body Surface Area of Psoriasis|The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|From Baseline to Day 15||||percentage change in body surface area||Standard Deviation|Mean
1314562|NCT02445807|Primary|Efficacy (Percentage of Subjects With Treatment Success)|"The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit.~The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets."|Day 15 Visit||||percentage of participants|||Number
1314563|NCT02445755|Primary|In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.||12 to 48 hours||||mg/dL||Standard Deviation|Mean
1314564|NCT02445573|Other Pre-specified|Adverse Events|Number of participants who experienced Adverse Events was collected.|weeks 1-30||||participants|||Number
1314565|NCT02445573|Secondary|Patient Self-evaluation of Therapeutic Effect|"Participants were asked to rate the extent of help that they received from treatment as no help, little help. moderate help or great help.~Number of participants reporting different extent of help was collected."|weeks 6, 18 and 30||||participants|||Number
1314566|NCT02445573|Secondary|Change From Baseline of the Total ICIQ-SF Scores|The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.It was used to assess the influence of urinary incontinence on quality of life during the past 4 weeks retrospectively. It contained three items on frequency, amount of leakage, and overall impact on quality of life, and a fourth, non-scored item for the assessment of type of incontinence. A total score was summed by the scores of the first three items, ranging from 0 to 21. A higher value indicates increased severity.|Baseline, and weeks 6, 18 and 30||||units on a scale||Standard Error|Mean
1314591|NCT02444715|Secondary|Change in Fruits and Vegetables Consumption|"Self-reported weekly portions of fruits and vegetables consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of fruits or vegetables and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on fruits and vegetables consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||portions||Inter-Quartile Range|Median
1314567|NCT02445573|Secondary|Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)|"Data of IEF was from 72-hour bladder diary recorded by participants over the last 72 hours of weeks 0 (baseline), weeks 2, 4, 6 (treatment period) and weeks 15-18,and 27-30 (follow-up period).~The 72-hour IEF of weeks 1-6 equaled the sum of 72h IEF at weeks 2, 4 and 6 divided by 3; The 72-hour IEF of weeks 15-18 equaled the sum of 72h IEF at weeks 15-18 divided by 4; The 72-hour IEF of weeks 27-30 equaled the sum of 72h IEF at weeks 27-30 divided by 4."|Baseline, weeks 1-6, weeks 15-18 and weeks 27-30||||episodes||Inter-Quartile Range|Median
1314568|NCT02445573|Primary|Change From Baseline of Urine Leakage Measured by 1-hour Pad Test||Baseline and week 6||||g||Inter-Quartile Range|Median
1314569|NCT02445326|Primary|Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|20 minutes||||units on a scale||Standard Deviation|Mean
1314570|NCT02445326|Primary|Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|15 minutes||||units on a scale||Standard Deviation|Mean
1314571|NCT02445326|Primary|Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|7 minutes||||units on a scale||Standard Deviation|Mean
1314572|NCT02445326|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|7 minutes||||units on a scale||Standard Deviation|Mean
1314573|NCT02445326|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|5 minutes||||units on a scale||Standard Deviation|Mean
1314574|NCT02445326|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|3 minutes||||units on a scale||Standard Deviation|Mean
1314575|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images SND|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-SND arm above.|||units on a scale|images|Standard Error|Mean
1314576|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-FDK arm above.|||units on a scale|images|Standard Error|Mean
1314577|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-High Resolution arm above.|||units on a scale|images|Standard Error|Mean
1314578|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 2D Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 total image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for each of the above two arms.|||units on a scale|images|Standard Error|Mean
1314592|NCT02444715|Primary|Change in BMI Value||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Weight data is missing for 9 of the 46 SC and 15 of the 48 IC participants who started the study.|||kg/m^2||Standard Deviation|Mean
1314579|NCT02445196|Secondary|Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)|PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.|Postreatment to 3-month Follow-up||||units on a scale||Standard Deviation|Mean
1314580|NCT02445196|Secondary|Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)|Depression was assessed with the Patient Health Questionnaire depression scale (PHQ-8; Kroenke et al., 2009), an 8-item self-report measure of depression with evidence showing its ability to measure depression symptom severity and potential diagnosis. Items are rated on how much the symptom bothered the respondent in the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 24, with higher scores indicating more severe depression symptoms. Cronbach’s alpha at baseline was .87.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
1314581|NCT02445196|Secondary|Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)|Psychosocial functioning was measured using the Brief Inventory of Psychosocial Functioning (B-IPF; Erb, Kearns, Bovin et al., 2015), a 7-item self-report measure. Items are rated on how much trouble the respondent had in the past month in relationships or other important areas of functioning (e.g., work, training or education) on a scale ranging from 0 (not at all) to 6 (very much). An average of applicable items provides an index of psychosocial functioning, with higher scores reflecting more poorer psychosocial functioning. Cronbach’s alpha at baseline was .82.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
1314582|NCT02445196|Secondary|Change in Subject Coping Self-efficacy Measured by a Questionnaire Assessing Confidence in Managing Core Symptoms of PTSD Addressed in the Intervention|PTSD symptom coping SE was assessed with a 9-item self-report measure developed for the study following Bandura’s guidelines (Bandura, 2006). Items assess confidence in managing PTSD symptoms and reaching out for support on a scale from 0 (cannot do at all) to 100 (highly certain can do). The average score provides an overall measure of SE with higher scores reflecting greater self-efficacy coping with PTSD symptoms. Cronbach’s alpha at baseline was .87.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
1314583|NCT02445196|Primary|Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)|PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
1314584|NCT02444936|Primary|Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures|To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.|3 years||||Participants|||Count of Participants
1314585|NCT02444936|Primary|Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)|To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.|3 years|||||||
1314586|NCT02444715|Other Pre-specified|Usability: SUS Score|"The usability of the intervention was assessed based on the standardised System Usability Scale (SUS).~SUS scores were not collected in the SC group because the SC participants were not using CAPSYS and hence were not able to assess its usability.~The System Usability Scale (SUS) provides a “quick and dirty”, reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.~The total SUS score computed based on the responses provided to each of the 10 items can range from 0 (worst) to 100 (best). Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average."|6 months|SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires.|||units on a scale (total SUS score)||Standard Deviation|Mean
1314587|NCT02444715|Secondary|Change in Quality of Life|"The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group.~In this context, the health value was specified by the participants on a subjective scale ranging from 0 (The worst health you can imagine) to 100 (The best health you can imagine)."|baseline and 6 months|Data on quality of life was retrieved from final questionnaires. Hence, QoL data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||units on a scale (health value)||Inter-Quartile Range|Median
1314588|NCT02444715|Secondary|Change in Duration of Physical Activity|Self-reported weekly duration of physical activity of medium or high intensity|baseline and 6 months|Data on physical activity was retrieved from final questionnaires. Hence, physical activity data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||minutes||Inter-Quartile Range|Median
1314593|NCT02444715|Primary|Change in Glycaemia Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Glycaemia data is missing for 6 of the 46 SC and 13 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
1314599|NCT02444533|Secondary|Number of Subjects With Post-tonsillectomy Bleeding|The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.|4 weeks|In the Liposomal Bupivacaine arm, 15 subjects had data on the primary endpoints, and an additional 2 provided information regarding post-procedure complications, but didn't provide data on other outcomes, therefore the analysis population for the Liposomal Bupivacaine is 17.|||Participants|||Count of Participants
1314600|NCT02444533|Secondary|Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)|Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.|4 weeks||||Participants|||Count of Participants
1314601|NCT02444533|Primary|Oral Intake (Patient Recorded Oral Intake)|Subjects recorded oral intake over one week after surgery|1 week after surgery||||mL||Standard Deviation|Mean
1314602|NCT02444533|Primary|Pain Medication Usage (Milligrams Used)|Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame|2 weeks after surgery|One subject on the no treatment arm was excluded for lack of follow up data, therefore 18 (from participant flow) -1 = 17.|||mg||Standard Deviation|Mean
1314603|NCT02444533|Primary|Pain Score (Pain Scores on a 0/10 Scale)|"Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated no pain and 10 indicated worst possible pain"|day of surgery, 14 days after surgery|Results include only subjects who were reported as having at least partial outcome data.|||units on a scale||Standard Deviation|Mean
1314604|NCT02444182|Primary|Plaque Index|"A modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque~= separate flecks of plaque at the cervical margin of the tooth~= a thin continuous band of plaque at the cervical margin~= a band of plaque wider than 1 mm but covering less than 1/3 of the crown~= plaque covering at least 1/3 but less than 2/3 of the crown~= plaque covering 2/3 or more of crown~An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined.~** Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)"|four weeks||||units on a scale||Standard Deviation|Mean
1314605|NCT02444182|Primary|Gingival Health|"The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered.~The criteria are:~0 = no inflammation~= mild inflammation, slight change in color, slight edema, no bleeding on probing~= moderate inflammation, moderate glazing, redness, bleeding on probing~= severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding~The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four.~The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined~A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation"|Four weeks||||units on a scale||Standard Deviation|Mean
1314606|NCT02443883|Secondary|Rate of Progression Free Survival at 6 Weeks|PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause.Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions,with reference being the smallest sum on study and plus absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions. If participant does not have complete baseline disease assessment,then PFS time will be censored at date of first dose,regardless of whether or not objectively determined disease progression or death has been observed for participant.If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis,PFS time will be censored at last adequate tumor assessment date.PFS survival rate at 6 weeks was estimated using the Kaplan-Meier method which takes into consideration who was censored prior to 6 weeks.|Baseline until Disease Progression or Death Due to Any Cause Up to 6 Weeks|All randomized participants. Censored participants: Ramucirumab Regimen 1 = 8, Ramucirumab Regimen 2 = 10, Ramucirumab Regimen 3 = 8 and Ramucirumab Regimen 4 = 12. The survival rate is not a direct result from (number of participants in arm 1 with PFS events up to 6 weeks)/(total number of participants in arm 1).|||Percentage of participants||95% Confidence Interval|Number
1314607|NCT02443883|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.|Predose Cycle 1 Through Short Term Follow Up (Up to 5 Months)|All randomized participants who received at least 1 dose of ramucirumab and had evaluable anti-ramucirumab antibody measurement.|||Participants|||Count of Participants
1314608|NCT02443883|Primary|Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab|The Cmin is the minimum observed serum concentration of ramucirumab.|Week 4, 6, 10 and 12: predose|All randomized participants who received at least one dose of ramucirumab and had evaluable ramucirumab PK data.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1314609|NCT02443792|Secondary|Infection|Proportion experiencing post-op infection, determined clinically (treated with antibiotics)|Up to 4 weeks||||participants|||Number
1314610|NCT02443792|Secondary|Wound Dehiscence|Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)|Up to 4 weeks||||participants|||Number
1314611|NCT02443792|Secondary|Completely Healed at 4 Weeks|Number of participants who were completely healed at 4 weeks|At the 4-week followup visit||||participants|||Number
1314612|NCT02443792|Secondary|Surgical Pain 0=no Pain; 10=Worst Pain Ever|Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever|Up to 30 minutes||||units on a scale||Standard Deviation|Mean
1314613|NCT02443792|Primary|Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing|Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing|Up to 30 minutes||||Minutes||Inter-Quartile Range|Median
1314614|NCT02443740|Secondary|Time to Reach Maximum Observed Cerebrospinal Fluid (CSF) Concentration (Tmax) of PF-05251749||Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||hour||Full Range|Median
1314615|NCT02443740|Secondary|Maximum Observed Cerebrospinal Fluid (CSF) Concentration (Cmax) of PF-05251749||Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314616|NCT02443740|Secondary|Area Under the Curve From Time Zero to Extrapolated Cerebrospinal Fluid (CSF) Infinite Time [AUC (0 - ∞)] of PF-05251749|AUC (0 -∞) = Area under the CSF concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted CSF concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1314617|NCT02443740|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Cerebrospinal Fluid (CSF) Concentration (AUClast) of PF-05251749|Area under the CSF concentration-time profile from time zero to the time of last quantifiable concentration (Clast).|Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1314618|NCT02443740|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Milled and Unmilled PF-05251749: Cohort 4||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||hour||Full Range|Median
1314619|NCT02443740|Secondary|Maximum Observed Plasma Concentration (Cmax) of Milled and Unmilled PF-05251749: Cohort 4||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314620|NCT02443740|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Milled and Unmilled PF-05251749: Cohort 4|AUC (0 -∞) = Area under the plasma concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1314621|NCT02443740|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Milled and Unmilled PF-05251749: Cohort 4|Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (Clast).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1314622|NCT02443740|Secondary|Apparent Volume of Distribution (Vz/F) of PF-05251749|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1314623|NCT02443740|Secondary|Apparent Oral Clearance (CL/F) of PF-05251749|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1314624|NCT02443740|Secondary|Plasma Decay Half-Life (t1/2) of PF-05251749|Terminal elimination half-life (t1/2). It was calculated as dividing the natural logarithm to the base e (Log e)*2/k el, where k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||hour||Standard Deviation|Mean
1314625|NCT02443740|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05251749||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK concentration analysis set included all enrolled participants who were treated and had at least 1 measurable concentration in at least 1 treatment period.|||hour||Full Range|Median
1314626|NCT02443740|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05251749|AUC (0 -∞) = Area under the plasma concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1314627|NCT02443740|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05251749|Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (Clast ).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1314628|NCT02443740|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05251749||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1314629|NCT02443740|Primary|Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) at 48 Hours Post Dose in Cohorts 1 and 2|ESRS is a clinician rated scale to assess parkinsonism,dystonia,dyskinesia,akathisia.The ESRS consists of 4 subscales and 4 clinicians global impressions-severity scales(CGI-S scales):I)a questionnaire of extrapyramidal symptoms or drug-induced movement disorders(a series of 4-point Likert scale questions with 0=Absent and 3=Severe);II)an examination of Parkinsonism and akathisia(7-point Likert scale with 0=Absent,6=extremely severe);III)an examination of dystonia(7-point Likert scale with 0=Absent,6=extremely severe);IV)an examination of dyskinesia(7-point Likert scale with 0=normal,6=most severe);V)toVIII)CGI-S scales(9-point Likert scale with 0=Absent,8=extremely severe)of tardive dyskinesia,parkinsonism,dystonia,akathisia.ESRS-Parkinsonism:total score range:0 to 14 where higher scores indicates greater severity;ESRS-dystonia:total score range:0 to 14 where higher scores indicates greater severity.Change from baseline was only observed in examination of parkinsonism and dystonia.|Baseline, Day 1: 48 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||units on a scale||Standard Deviation|Mean
1314630|NCT02443740|Primary|Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) at 2 Hours Post Dose in Cohorts 1 and 2|ESRS is a clinician rated scale to assess parkinsonism,dystonia,dyskinesia,akathisia.The ESRS consists of 4 subscales and 4 clinicians global impressions-severity scales(CGI-S scales):I)a questionnaire of extrapyramidal symptoms or drug-induced movement disorders(a series of 4-point Likert scale questions with 0=Absent and 3=Severe);II)an examination of Parkinsonism and akathisia(7-point Likert scale with 0=Absent,6=extremely severe);III)an examination of dystonia(7-point Likert scale with 0=Absent,6=extremely severe);IV)an examination of dyskinesia(7-point Likert scale with 0=normal,6=most severe);V)toVIII)CGI-S scales(9-point Likert scale with 0=Absent,8=extremely severe)of tardive dyskinesia,parkinsonism,dystonia,akathisia.ESRS-Parkinsonism:total score range:0 to 14 where higher scores indicates greater severity;ESRS-dystonia:total score range:0 to 14 where higher scores indicates greater severity.Change from baseline was only observed in examination of parkinsonism and dystonia.|Baseline, Day 1: 2 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||units on a scale||Standard Deviation|Mean
1314631|NCT02443740|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 48 Hours Post Dose in Cohorts 1 and 2|The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.|Baseline, Day 3: 48 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||millimeter||Standard Deviation|Mean
1314632|NCT02443740|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 6 Hours Post Dose in Cohorts 1 and 2|The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.|Baseline, Day 1: 6 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||millimeter||Standard Deviation|Mean
1314633|NCT02443740|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 2 Hours Post Dose in Cohorts 1 and 2|The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.|Baseline, Day 1: 2 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||millimeter||Standard Deviation|Mean
1314650|NCT02443402|Secondary|Intensive Care Unit (ICU) Mortality Rate|The total number of subject deaths during ICU stay will be recorded.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314634|NCT02443740|Primary|Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Findings|ECG parameters included maximum pulse rate (PR) interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for abnormal ECG: Maximum PR interval >=300 milliseconds (msec) or >=25 percent increase when baseline is >200 msec and >=50 percent increase when baseline is less than or equal to (=<) 200 msec; QRS interval >=140 msec or >=50 percent increase from baseline (IFB); and QTcF 30<=change<60 or change>=60 msec increase. The number of participants with abnormal ECG findings are reported.|Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1314635|NCT02443740|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria for clinically significant change from baseline in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP greater than or equal to (>=)30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1314636|NCT02443740|Primary|Number of Participants With Laboratory Abnormalities|Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN), MCV,MCH,MCHC,MPV:<0.9*LLN or >1.1*upper limit of normal(ULN), platelet:<0.5*LLN or >1.75*ULN, white blood cell(WBC):<0.6*LLNor>1.5*ULN, lymphocyte,neutrophil,total neutrophil:<0.8*LLN or >1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN; PTT, PT:>1.1*ULN,Fibrinogen<0.75*ULNor>1.25ULN; total, direct, indirect bilirubin >1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;sodium:<0.95*LLN or>1.05*ULN,potassium,chloride, calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN, phosphate<0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN,creatine kinase>2.0*ULN;urine(specific gravity<1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >=20*ULN,bacteria>20);CSF (WBC>=6,RBC>0,Albumin>35).|Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1314637|NCT02443740|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|For Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1314638|NCT02443402|Secondary|Number of Subject Requiring Surgical Re-Intervention|The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314639|NCT02443402|Secondary|Number of Subjects Requiring Re-intubation Within 24 Hours|The number of subjects requiring re-intubation with 24 after CABG.|Post-Surgery (Up to 24 Hours)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314640|NCT02443402|Secondary|Number of Subjects Requiring Re-intubation|The number of subjects requiring re-intubation after CABG.|Post-Surgery (Up to 2 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314641|NCT02443402|Secondary|Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours|The number of subjects requiring the use of inotropes for >24 hours post CABG.|Post-Surgery (Up to 2 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314642|NCT02443402|Secondary|Number of Participants With Infections Not Requiring Hospital Re-admission|Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314643|NCT02443402|Secondary|Number of Participants With Emergency Room (ER) Visits|Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314644|NCT02443402|Secondary|Number of Participants Re-admitted to the Hospital Not Due to Wound Infections|Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314645|NCT02443402|Secondary|Number of Participants Re-admitted to the Hospital Due to Wound Infections|Number of subjects readmitted to the hospital within 30 days due to wound infection.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314646|NCT02443402|Secondary|Length of Hospital Stay After Study Randomization|Number of days in the hospital after a participant is randomized to a study intervention.|Post-Randomization (Up to 9 days)|Participants that completed all study assessments.|||days||Inter-Quartile Range|Mean
1314647|NCT02443402|Secondary|Length of Stay: Intensive Care Unit (ICU)|Number of days in the ICU after coronary artery bypass graft surgery (CABG).|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||days||Inter-Quartile Range|Mean
1314648|NCT02443402|Secondary|Hospital Complication Rate|The total number of all complications experienced during hospitalization. Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate.|Duration of Hospitalization (Up to 30 days)|Participants that completed all study assessments.|||number of complications|||Number
1314649|NCT02443402|Secondary|Number of Participants With Cerebrovascular Events|Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.|Post-Hospital Discharge (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314652|NCT02443402|Secondary|Number of Participants With Blood Glucose Less Than 40 mg/dl|Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.|Duration of Hospitalization (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314653|NCT02443402|Secondary|Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)|Number of participants with blood glucose (BG) <70 after transition from ICU.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314654|NCT02443402|Secondary|Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay|Number of participants with blood glucose (BG) <70 during ICU stay.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314655|NCT02443402|Secondary|Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)|Number of participants with blood glucose (BG) >180 after transition from ICU.|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314656|NCT02443402|Secondary|Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)|Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314657|NCT02443402|Secondary|Total Insulin Therapy in the Intensive Care Unit (ICU)|Total amount of insulin glargine insulin (units) administered in the ICU per day.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||units per day||Standard Deviation|Mean
1314658|NCT02443402|Secondary|Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)|The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU. The normal BG range for someone with diabetes is 80-130 mg/dL.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||mg/dl||Standard Deviation|Mean
1314659|NCT02443402|Secondary|Mean Units Subcutaneous (SQ) Insulin Required|Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||units||Standard Deviation|Mean
1314660|NCT02443402|Secondary|Duration of Continuous Intravenous Insulin (CII)|Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.|Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)|Participants that completed all study assessments.|||hours||Inter-Quartile Range|Mean
1314661|NCT02443402|Secondary|Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)|The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU. The more insulin given, the more hyperglycemic events experienced.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||units per day||Standard Deviation|Mean
1314662|NCT02443402|Secondary|Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration|The blood glucose levels will be assessed throughout the day using a glucose meter. An average will be calculated. The normal BG range for someone with diabetes is 80-130 mg/dL.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||mg/dL||Standard Deviation|Mean
1314663|NCT02443402|Secondary|Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia|Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314664|NCT02443402|Primary|Number of Subjects With Persistent Hyperglycemia|Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314665|NCT02443402|Primary|Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)|Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
1314666|NCT02443103|Secondary|Treatment Related Adverse Events|Number of unique patients who had a treatment related (possible, probable or definite) adverse events.|Up to 1 year|All patients enrolled and received treatment.|||Participants|||Count of Participants
1314667|NCT02443103|Primary|Bone Turnover Markers-bone Formation and Bone Resorption|Number of patients who had blood specimens taken to collect and evaluate markers of bone formation and bone resorption. Note - due to poor accrual and early closure, bone marker data was not collected.|Day 0, Week 8, Week 12|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit with bone marker information available.||||||
1314668|NCT02442830|Secondary|Number of Participants With Localization of Bleeding by the End of Admission|This measurement counts the number of participants with a bleeding source localized by the end of admission.|Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards.||||Participants|||Count of Participants
1314669|NCT02442830|Primary|Time to Localization of Bleeding|Time to localization of bleeding refers to the time after a patient is admitted to the emergency room and a bleeding source is localized. We defined localization of bleeding as endoscopic visualization of stigmata of recent hemorrhage.|Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.||||hours||Inter-Quartile Range|Median
1314670|NCT02442804|Secondary|Change From Baseline State-Trait Anxiety Inventory - Trait Score|The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee’s general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from “not at all” to “very much so.” Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms.|Baseline and Day 9||||raw score||Standard Deviation|Mean
1319141|NCT02320838|Primary|Mechanical Pain Threshold During Treatment|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|during treatment at 15 min||||N||Standard Deviation|Mean
1314671|NCT02442804|Secondary|Change From Baseline State-Trait Anxiety Inventory - State Score|The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee’s general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from “not at all” to “very much so.” Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms.|Baseline and Day 9||||raw score||Standard Deviation|Mean
1314672|NCT02442804|Secondary|Change From Baseline Beck Depression Inventory - II (BDI-II) Score|The Beck Depression Inventory – Second Edition (BDI-II) is a widely used self-report questionnaire of depressive symptoms. The examinee is asked to respond to 21 items by endorsing whether or not they experience symptoms of sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentrating difficulty, tiredness or fatigue, and loss of interest in sex. Examinees can also describe the degree of severity of each symptom, as each item ranges from 0-3. The scorer adds the scores for each item to attain a total score, which is interpreted according to the following guidelines: 0-13 = minimal depression, 14-19 = mild depression, 20-28 = moderate depression, 29-63 = severe depression|Baseline and Day 9||||raw score||Standard Deviation|Mean
1314673|NCT02442804|Secondary|Change From Baseline Animals Fluency Score|The Animal Fluency task involves providing the examinee a category prompt. For example, the examiner asks the examinee to name as many animals as he or she can in 1 minute. The total number of acceptable words is tallied for a total score (ranging from 0 on up). Higher scores indicate better performance.|Baseline and Day 9||||number of acceptable words (animals)||Standard Deviation|Mean
1314674|NCT02442804|Secondary|Change From Baseline Trail-making Test Part B Score|The Trail-making Test Part B consists of circles with either numbers (1 - 13) or letters (A - L) in them; as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.|Baseline and Day 9||||seconds||Standard Deviation|Mean
1314675|NCT02442804|Secondary|Change From Baseline Line Bisection Test Score|The Line Bisection Test consists of 20 horizontal lines of varying length and proximity to the center of a sheet of paper (i.e., some are closer to the left or right sides of the page). The examinee is asked to place a mark to bisect each line. The scorer measures the degree of deviation from the center of each line (in cm) and attains the absolute value of the average percentage of deviation across all 20 lines. The scorer also attains the dominant direction of deviation (i.e., whether the examinee misses more to the left or to the right on average across the 20 lines). The value of the largest deviation is imputed for any omissions. Percentage ranges from 0 on up. Higher percentage of deviation indicates worse performance.|Baseline and Day 9||||percentage of deviation from center||Standard Deviation|Mean
1314676|NCT02442804|Secondary|Change From Baseline Controlled Oral Word Association Test Score|The Controlled Oral Word Association Test (COWAT) is a measure of controlled verbal fluency that involves the examinee naming as many words that begin with a certain letter of the alphabet as he or she can in 1 minute. There are a few rules (i.e., no proper nouns and no words that have the same meaning and only differ by its suffix) and the task is repeated twice more with different letters each time. The scorer tallies the total acceptable words from all 3 trials into one total score (ranges from 0 on up). Higher total score indicates better performance.|Baseline and Day 9||||number of acceptable words||Standard Deviation|Mean
1314677|NCT02442804|Secondary|Change From Baseline Brief Test of Attention Score|On the Brief Test of Attention (BTA), the examinee listens to a string of numbers and letters and must mentally tally (without the use of their fingers) how many numbers are in a particular trial. They do this for 10 trials and then are given 10 additional trials with the task of tallying how many letters they hear. The task increases in difficulty as the trials progress, and the entire test takes 5-10 minutes to complete. The scorer adds the number of trials correct from all 20 trials to attain a total score (ranges from 0 to 20). Higher scores indicate better performance.|Baseline and Day 9||||raw score||Standard Deviation|Mean
1314678|NCT02442804|Secondary|Change From Baseline Trail-making Test Part A Score|The Trail-making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Results for the test are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.|Baseline and Day 9||||seconds||Standard Deviation|Mean
1314679|NCT02442804|Secondary|Change From Baseline Functional Independence Measure (FIM) Score|Functional Independence Measure (FIM) Score consists of eighteen sub-measures under the following 6 categories: Self-Care (eating, grooming, bathing, dressing upper body, dressing lower body, toileting), Sphincter Control (bladder control, bowel control), Transfers (bed/chair/wheelchair transfer, toilet transfer, tub/shower transfer), Locomotion (walk/wheelchair, stairs), Communication (comprehension, expression), and Social Cognition (social interaction, memory, problem solving). Scores for each sub-measure range from 1 (total assistance) to 7 (complete independence), and the 18 scores are summed to obtain the FIM score. Higher scores indicate better performance.|Baseline and Day 9||||raw score||Standard Deviation|Mean
1314680|NCT02442804|Secondary|Change From Baseline Mini-Mental State Examination - 2nd Edition Score|The MMSE-2 is a brief (about 10 minutes) screening tool that touches upon orientation to time and place, recall, attention/calculation, naming, repetition, comprehension, reading, writing, and drawing, with all the scores from these domains cumulating to a maximum of 30 points (minimum = 0). Higher score indicates better performance.|Baseline and Day 9||||raw score||Standard Deviation|Mean
1314692|NCT02442284|Secondary|Percentage of Participants With Virologic Failure During Treatment|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.|up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1314681|NCT02442804|Primary|Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) provides both a total scale score and scores for 5 different cognitive domains. It is relatively brief (approximately 20 minutes total) and has alternate forms. Specifically, the test measures immediate memory (with list learning and story memory), visuospatial/constructional ability (with figure copy and line orientation), language (with picture naming and semantic fluency), attention (with digit span and coding), and delayed memory (with list recall, list recognition, story recall, and figure recall). Scores from all subtests are aggregated into a total composite score (manual provides conversion procedure). RBANS data were age-normed based on the sample described in the manual (Randolph, 2012) and were analyzed as index scores (also referred to as standard scores), which have a mean of 100 and a standard deviation of 15. Higher scores on each sub measure and index indicate better performance.|Baseline and Day 9||||standard score change||Standard Deviation|Mean
1314682|NCT02442700|Secondary|Safety of Pitavastatin in HIV-infected Patients|"Safety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event.~Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo."|12 weeks||||U/L||95% Confidence Interval|Mean
1314683|NCT02442700|Primary|Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir|Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.|12 weeks||||mg/dL||95% Confidence Interval|Mean
1314684|NCT02442349|Secondary|Disease Control Rate (DCR) According to RECIST 1.1|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from time first dose until date of progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).|All patients who received at least 1 dose of study treatment and had measurable disease at baseline by blinded independent central review (BICR) of baseline imaging data.|||% of participants||95% Confidence Interval|Number
1314685|NCT02442349|Primary|Objective Response Rate (ORR) According to RECIST 1.1|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from time of first dose until objective disease progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).|All patients who received at least 1 dose of study treatment and had measurable disease at baseline by blinded independent central review (BICR) of baseline imaging data.|||% of participants||95% Confidence Interval|Number
1314686|NCT02442310|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)|The safety population included all subjects who received at least one of the investigational products under study.|||participants|||Number
1314687|NCT02442310|Primary|AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest|||ug*h/mL||Standard Deviation|Mean
1314688|NCT02442310|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest|||Hour||Standard Deviation|Mean
1314689|NCT02442310|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest|||μg/mL||Standard Deviation|Mean
1314690|NCT02442284|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) and with ongoing psychiatric disorders.|||percentage of participants||95% Confidence Interval|Number
1314691|NCT02442284|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1314693|NCT02442284|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1314694|NCT02442271|Secondary|(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1314695|NCT02442271|Secondary|Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1314696|NCT02442271|Secondary|Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1314697|NCT02442271|Secondary|Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.|||percentage of participants||95% Confidence Interval|Number
1314698|NCT02442271|Secondary|Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.|||percentage of participants||95% Confidence Interval|Number
1314699|NCT02442271|Secondary|Percentage of Participants With SVR12 by Fibrosis Stage|SVR12 was defined as plasma HCV RNA level <LLOQ]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.|||percentage of participants||95% Confidence Interval|Number
1314700|NCT02442271|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1314701|NCT02441946|Secondary|PK: Volume of Distribution of Abemaciclib and Anastrozole||Post dose Cycle 1 Day 1 through Cycle 5 Day 28 (16 Weeks)||2018-03-31|03/2018||||
1314702|NCT02441946|Secondary|Pharmacokinetics (PK): Clearance of Abemaciclib and Anastrozole||Post dose Cycle 1 Day 1 through Cycle 5 Day 28 (16 Weeks)||2018-03-31|03/2018||||
1314703|NCT02441946|Secondary|Change From Baseline to Week 2 in Toxicity Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)||Baseline, 2 Weeks||2018-03-31|03/2018||||
1314736|NCT02440633|Primary|AUC of OPS-2071 in Plasma|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.||||μg·h/L||Standard Deviation|Mean
1314790|NCT02437513|Other Pre-specified|Number of Participants With Reported Device Migration in the Larynx Post Implant|In patient change from baseline position of the device in the larynx of each patient assessed by endoscopy and/or other clinically appropriate methods (CT or video fluoroscopy) and recorded in migration direction and distance (cm)|1 weeks||||participants|||Number
1314704|NCT02441946|Secondary|Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response|Radiological response is the percentage of participants with CR, PR and SD according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.|From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)|All participants who received combination treatment post cycle 1 and had evaluable radiological response data. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.|||percentage of participants|||Number
1314705|NCT02441946|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response|Clinical objective response is defined as the percentage of participants with the best overall response rate (ORR) with a best OR of CR or PR, according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. ORR is recorded from the start of the study treatment until the earliest of objective progression or start of new anticancer therapy. A responder depends on target and non-target disease and the appearance of new lesions. CR is defined as the disappearance of all non-target lesions. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. All lymph nodes are non-pathological or normal in size (<10mm short axis). Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, a relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm.|From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)|All participants who received combination treatment post cycle 1 and had evaluable clinical objective response data. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.|||percentage of participants|||Number
1314706|NCT02441946|Secondary|Percentage of Participants With Pathologic Complete Response (pCR)|pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.|From Start of Treatment Up to 16 Weeks|All participants who received combination treatment post cycle 1 and had evaluable pCR data. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.|||percentage of participants|||Number
1314707|NCT02441946|Primary|Percent Change From Baseline to 2 Weeks in Ki67 Expression|Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.|Baseline, 2 Weeks|All randomized participants who received at least one dose of study drug and a valid baseline Ki67 measurement of at least 5% and a valid 2-week measurement of any magnitude.|||Percent Change||90% Confidence Interval|Geometric Mean
1314708|NCT02441517|Secondary|Number of Participants With Adverse Events|Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. Disease progression was not to be reported as an AE, and clinical signs and symptoms due to disease progression were collected as AEs.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the SAF.|||Participants|||Count of Participants
1314709|NCT02441517|Secondary|Time to First Use of a Subsequent Antineoplastic Therapy|Time to start of other antineoplastic therapy was defined as the date of the first systemic antineoplastic therapy minus the date of the first dose of study drug + 1.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants who underwent subsequent antineoplastic therapy were included in the analysis.|||days||95% Confidence Interval|Median
1314710|NCT02441517|Secondary|Number of Participants With Objective Response|Objective response was defined as the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants with measurable disease at baseline were included in the analysis.|||Participants|||Count of Participants
1314711|NCT02441517|Secondary|Number of Participants With PSA Response|PSA response was defined for the three following categories: PSA30 response: a maximum decline of ≥ 30% from baseline at any post baseline time point; PSA50 response: a maximum decline of ≥ 50% from baseline at any post baseline time point; PSA90 response: a maximum decline of ≥ 90% from baseline at any post baseline time point.|From baseline up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants with at least 1 postbaseline PSA measure were included in the analysis.|||Participants|||Number
1314712|NCT02441517|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|The time to PSA progression was defined as the PSA progression date minus the date of first dose + 1. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (lowest PSA value observed postbaseline or the baseline value for participants who did not have a decline in PSA postbaseline values) in PSA levels, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The date of PSA progression was the first date the PSA progression was observed. Time to PSA progression was estimated via Kaplan-Meier methodology with censoring defined by the time of the last available PSA measure.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS.|||days||95% Confidence Interval|Median
1314713|NCT02441517|Secondary|Overall Survival|Overall survival (OS) was defined as the date of death due to any cause minus the date of first dose + 1.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants with an overall survival event were included in the analysis.||||||
1314714|NCT02441517|Primary|Radiographic Progression Free Survival (rPFS)|Radiographic PFS (rPFS) was defined as the time from first dose to the radiographic disease progression (PD), or death on study, whichever occurred first. Radiological PD was defined by either soft tissue tumor progression defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, or bone progression defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2). Bone progression per PCWG2 was defined as a minimum of two new lesions. Progression on bone scans at time points before or at week 9 required a confirmatory scan performed six or more weeks later, where it should have demonstrated at least 2 additional new lesions (PCWG2) compared to the week 9 scan. rPFS was analyzed using Kaplan-Meier methodology to account for censored outcomes (i.e., no observation of rPFS event within the study follow-up period).|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the full analysis set (FAS), which consisted of all participants who are enrolled in the study, received at least one dose of study drug, and have at least one post baseline evaluation.|||days||95% Confidence Interval|Median
1314715|NCT02441218|Secondary|Secondary Composite Endpoint|CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction|From the date of randomisation to the date of the first event, up to 42 months||||participants|||Number
1314716|NCT02441218|Secondary|Unplanned Hospitalisation for CV Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months.||||participants|||Number
1314717|NCT02441218|Secondary|Unplanned Hospitalisation for Any Cause||From the date of randomisation to the first documented hospitalisation, up to 42 months||||participants|||Number
1314718|NCT02441218|Secondary|Hospitalisation for Cardiovascular Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months||||participants|||Number
1314719|NCT02441218|Secondary|Hospitalisation for Any Cause||From the date of randomisation to the date of first documented hospitalisation, up to 42 months||||participants|||Number
1314720|NCT02441218|Secondary|Death From Heart Failure|Component of cardiovascular death|From the date of randomisation to death, up to 42 months.||||participants|||Number
1314721|NCT02441218|Secondary|All-cause Mortality||From the date of randomisation to death, up to 42 months.||||participants|||Number
1314722|NCT02441218|Secondary|Hospitalisation for Worsening Heart Failure||From the date of randomization to the date of first documented hospitalisation, up to 42 months||||participants|||Number
1314723|NCT02441218|Secondary|Cardiovascular Death|Component of the primary composite endpoint|From the date of randomization until the date of death, up to 42 months||||participants|||Number
1314724|NCT02441218|Primary|Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.|Number of patients having experienced the Primary Composite Endpoint.|All over the study (up to 42 months).||||participants|||Number
1314725|NCT02441179|Secondary|Learning and Memory With the Complutense Verbal Learning Test (TAVEC)|"The TAVEC is the Spanish version of the California Verbal Learning Test and is used for the assessment of episodic verbal memory.~Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.~Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic verbal memory at week 4.|"Analysis per protocol"|||Z scores||Inter-Quartile Range|Median
1314726|NCT02441179|Secondary|Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test|"The ROCF is a neuropsychological instrument used for assessment of episodic visual memory.~Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.~Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic visual memory at week 4.|"Analysis per protocol"|||Z scores||Inter-Quartile Range|Median
1314727|NCT02441179|Secondary|"Percentage of Subjects With Worsening Pain Perception on the The Visual Analog Test"|The visual analog test assess general pain intensity. It is a 10-score scale ranging from no pain (score 0) to unbearable pain (score 10).|Pain perception at week 4|"Analysis per protocol"|||percentage of subjects|||Number
1314728|NCT02441179|Secondary|Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale|The Ashworth Scale assess muscle tone. It is a 5-points scale ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension).|Muscle tone at week 4.|"Analysis per protocol"|||percentage of subjects|||Number
1314729|NCT02441179|Secondary|Gait Speed With the Timed up and go Test|The timed up and go test measures the time (in seconds) it takes the patient to stand-up from a seated position in a chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down.|Change from baseline in gait speed five days after daily IH.|"The analysis was per protocol"|||seconds||Standard Error|Mean
1314730|NCT02441179|Secondary|Gait Endurance With the 6-Minute Walk Test|The 6-Minute Walk Test measures the distance (in meters) a patient is able to walk over 6 minutes.|Change from baseline in gait indurance five days after daily IH.|"The analysis was per protocol"|||meters||Standard Error|Mean
1314731|NCT02441179|Primary|Gait Speed With 10-Meter Walk Test|The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.|Change from baseline in gait speed five days after daily IH.|"Analysis was per protocol"|||seconds||Standard Error|Mean
1314732|NCT02441114|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3|||pg/mL||Standard Deviation|Mean
1314733|NCT02441114|Secondary|Time to Maximum Concentration (Tmax)|Time to maximum concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3|||h||Full Range|Median
1314734|NCT02441114|Primary|Area Under the Concentration Versus Time Curve (AUClast)|Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3|||h*pg/mL||Standard Deviation|Mean
1314735|NCT02440659|Primary|Patient's Quality of Life|% of patients very much or extremely affected by dialysis|Baseline||||% of patients|||Number
1319430|NCT02316366|Secondary|Amount of Narcotic Administered|The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient|4 hours||||mg/kg||95% Confidence Interval|Mean
1314737|NCT02440633|Primary|Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.||||μg eq.·h/L||Standard Deviation|Mean
1314738|NCT02440633|Primary|The Amounts of Radioactivity Excreted in Urine and Faeces|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.|up to144-168h postdose.||||percentage of administered dose||Standard Deviation|Mean
1314739|NCT02440308|Secondary|68Ga-DOTA-Bombesin Feasibility|Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.|Up to 1 week|Includes all participants enrolled.|||percentage of participants|||Number
1314740|NCT02440308|Primary|Normal Biodistribution of 68Ga-DOTA-Bombesin|Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.|1 hour|All participants were averaged to provide SUVmean uptake in normal organs.|||SUV-mean||Standard Deviation|Mean
1314741|NCT02439879|Primary|Total Symptoms Score|Total symptoms score is a summation of presence, severity, and duration of the four main positive neuropathic sensory symptoms: lancinating/stabbing pain, burning pain, paresthesia, and asleep numbness|20 weeks||||units on a scale||Standard Error|Mean
1314742|NCT02439814|Primary|Subjective Rating of Marijuana Craving on 1-7 Likert Scale|Change in craving from post medication administration to post active cue. Scale of 1-7 with 7 meaning the craving is most severe.|12:40 to 14:45 (post med administration, post Marijuana cue||||units on a scale||Standard Deviation|Mean
1314743|NCT02439164|Secondary|Brain Glioma Pathological Diagnose as a Measure of Tumor Type|the WHO grade and the type of glioma (WHO glioma grade I~II is regarded as low grade glioma, WHO glioma grade III~IV is regarded as high grade glioma)|2 weeks|"In non-neurosurgical group, patients were not diagnosed as glioma, so the belowed outcome measure data table could not indicate the number of glioma grade."|||Participants|||Count of Participants
1314744|NCT02439164|Secondary|Heart Rate as a Measure of Physiological Change|The HR was measured at three time points: baseline, sedation and sedation reversal.|1 hour||||bpm||Standard Deviation|Mean
1314745|NCT02439164|Secondary|Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change|The MAP was measured at three time points: baseline, sedation and sedation reversal.|1 hour||||mmHg||Standard Deviation|Mean
1314746|NCT02439164|Secondary|Number of Participants With OAA/S=4 After Sedation|OAA/S is Observer Assessment of Sedation with 5 levels (5 = alert, 4 = lethargic, 3 = aroused by voice, 2 = aroused by shaking, 1 = deep sleep), all participants have to achieve OAA/S=4 after sedation.|withing 1 hour||||Participants|||Count of Participants
1314747|NCT02439164|Primary|Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test|this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.|after sedation||||seconds||Standard Deviation|Mean
1314748|NCT02439138|Secondary|Rate of Progressive Disease|Progressive disease measured by an 25% increase in serum IgM level with an absolute increase of at least 500mg/dL from the lowest attained IgM on therapy.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with PD|||Number
1314749|NCT02439138|Secondary|Rate of Stable Disease|Stable disease measured by serum IgM levels <25% reduced from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with SD|||Number
1314750|NCT02439138|Secondary|Rate of Minimal Response|Minimal response measured by decrease in serum IgM levels of between 25% and 50%.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with MR|||Number
1314751|NCT02439138|Secondary|Rate of Partial Response (PR)|PR measured by decrease in serum IgM levels of between 25% and 50% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with PR|||Number
1314752|NCT02439138|Secondary|Rate of Very Good Partial Response (VGPR)|VGPR measured by decrease in serum IgM levels of at least 90% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with VGPR|||Number
1314753|NCT02439138|Secondary|Rate of Complete Response (CR)|CR measured by decrease in serum IgM levels to normal range, disappearnace of monoclonal protein by immunofixation, no evidence of bone marrow involvement, and resolution of any extramedullary disease by CT scan.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with CR|||Number
1314754|NCT02439138|Secondary|Percentage of Participants With Adverse Events|Assess the safety and tolerability of idelalisib|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with AEs|||Number
1314755|NCT02439138|Primary|Overall Response Rate (ORR)|ORR measured by decrease in serum IgM level by at least 25% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|4 of 5 participants returned for at least 1 follow-up to assess disease response.|||percentage of participants with response|||Number
1314756|NCT02438540|Secondary|HOMA-IR|Changes of IR was calculated by the homeostasis model (HOMA-IR), proposed by Matthews et al. HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22•5. Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||units on a scale||Standard Deviation|Mean
1314758|NCT02438540|Primary|Serotonin|changes in Serotonin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||ng/ml||Standard Deviation|Mean
1314759|NCT02438540|Primary|Resistin|Changes in Resistin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||ng/ml||Standard Deviation|Mean
1314760|NCT02438540|Primary|Glucagon-like Peptide-1 (GLP-1)|changes in GLP-1 blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
1314761|NCT02438540|Primary|Adiponectin|Changes in Adiponectin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||µg/ml||Standard Deviation|Mean
1314762|NCT02438540|Primary|Leptin|changes in Leptin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||ng/ml||Standard Deviation|Mean
1314763|NCT02438540|Primary|Ceramides|Changes in ceramides blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||g/dl||Standard Deviation|Mean
1314764|NCT02438540|Primary|High Density Lipoprotein Cholesterol (HDLc)|HDLc changes, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
1314765|NCT02438540|Primary|Low Density Lipoprotein Cholesterol (LDLc)||baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
1314766|NCT02438540|Primary|Triglyceride (TG)||baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
1314767|NCT02438540|Primary|Free Fatty Acids (FFAs)|Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
1314768|NCT02438540|Primary|C-reaction Protein (CRP)|CRP blood markers changes; Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mg/dl||Standard Deviation|Mean
1314769|NCT02438540|Primary|Tumor Necrosis Factor-α (TNF-α)|Blood markers changes in TNF α, were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||Pg/ml||Standard Deviation|Mean
1314770|NCT02438540|Primary|Interleukin-6 (IL-6)|IL-6 changes, IL-6 were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||Pg/dl||Standard Deviation|Mean
1314771|NCT02438540|Primary|Fasting Insulin (FINS)|change of FINS,Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||µIU/ml||Standard Deviation|Mean
1314772|NCT02438540|Primary|Fasting Blood Sugar (FBS)|changes FBS, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
1314773|NCT02438540|Primary|Body Weight|The effect of Metformin and acupuncture combined therapy on weight loss (Change from baseline in body weight), body weight was measured while the subjects were dressed in light clothing after an overnight fasting and by a standard scale to an accuracy of +/-0.1 kg. All measures were recorded by one assessment, at baseline before the first time treatment, and before the last time treatment at week 3.|baseline, week 3||||kg||Standard Deviation|Mean
1314774|NCT02438280|Secondary|Final Alignment Scores of the Upper and Lower Incisors|Final alignment was measured using Little's incisor irregularity index. This index sums the displacement of the contact points of the anterior teeth, to produce a millimetric number. The lower the score, the more perfect the alignment.|6 months|Final incisor irregularity, measured in millimeters|||Little's irregularity index (mm)||Standard Deviation|Mean
1314775|NCT02438280|Primary|Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)|The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.|6 months|The outcome was the ability to complete the initial set of aligners|||Participants|||Count of Participants
1314776|NCT02438137|Secondary|Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values)|Levels of markers in the blood known as cytokines (measured in picograms per milliliter) were measured on a monthly basis from Month 0 (baseline) to Month 4. The outcome is the mean difference in cytokine level from baseline to month 4 (mean level at Month 4 - mean level at Baseline). Values were log-transformed for normality, prior to analysis.|Month 0 to Month 4|Cytokine analyses were conducted for those participants who completed the study and had interpretable Month 4 PSG results. Among this group, 3 participants did not have usable Month 4 blood specimens for this analysis. Thus, the mean difference in cytokine levels was calculated for 47 participants.|||picograms/milliliter (log-transformed)||Standard Deviation|Mean
1314777|NCT02438137|Primary|Mean Change in Apnea Severity as Measured by the Respiratory Disturbance Index (RDI)|For the 50 participants who had interpretable month 4 polysomnography (PSG) data available, mean change in sleep apnea severity, as measured by the mean change in respiratory disturbance index (RDI) between baseline (Month 0) PSG and Month 4 PSG, was calculated. The RDI represents the total number of apneas, hypopneas and respiratory-related arousals per hour of sleep.|Month 0 to Month 4|65 participants were randomized. 14 participants withdrew from the study or were lost to followup. 51 completed study activities. 50 (35 DMF and 15 placebo) both completed the study and had an interpretable Month 4 PSG. One participant's Month 4 PSG was uninterpretable, thus the RDI from this participant could not be included in the final analysis.|||respiratory events/hour||Standard Deviation|Mean
1314778|NCT02437903|Other Pre-specified|Number of Participants With Specific Site Treatment Responses|Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections|Day 14|Total number of subjects that reported symptom|||Participants|||Count of Participants
1314779|NCT02437903|Other Pre-specified|Subject Self-Perception of Age|Subjects perception of age when the subject looks at his/her right and left temples|Baseline, month 1, month 3, month 6, month 9, and Month 12|All subjects with data for this outcome measure|||Participants|||Count of Participants
1314780|NCT02437903|Other Pre-specified|Subject’s Satisfaction With Temple Appearance|Subject’s Satisfaction with Temple Appearance|Baseline, month 1, month 3, month 6, month 9, and Month 12|All subjects with data for this outcome measure|||Participants|||Count of Participants
1314781|NCT02437903|Secondary|Investigator's Satisfaction With the Appearance of the Temporal Regions|Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient’s right side and not the investigator’s right side.|Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12|All subjects with data for this outcome measure|||Participants|||Count of Participants
1314782|NCT02437903|Primary|Frontal Temporal Fossa Rating Scale|Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.|Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12|All subjects with data for for this outcome measure|||Participants|||Count of Participants
1314783|NCT02437864|Secondary|Patients' Lowest Pulse Oximetry Value Observed During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||percent||Inter-Quartile Range|Median
1314784|NCT02437864|Secondary|Number of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||Participants|||Count of Participants
1314785|NCT02437864|Secondary|Number of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||Participants|||Count of Participants
1314786|NCT02437864|Secondary|Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||Participants|||Count of Participants
1314787|NCT02437864|Primary|Time to First Event: Pulse Oximetry Falling to 95%, or Successful Intubation||From anesthetic induction to whichever comes first: pulse oximetry falling to 95%, or successful intubation; an expected average of 10 minutes||||seconds||Inter-Quartile Range|Median
1314788|NCT02437513|Other Pre-specified|Reported Subjective Rating of Comfort of the Device in the Larynx|In patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12|12 weeks|||||||
1314789|NCT02437513|Other Pre-specified|Change From Baseline of Quality of Life (QoL) Score|In patient QoL assessed at baseline and at 12 weeks using German standard QoL clinical questionnaire specifically for patients with swallowing dysfunction|12 weeks|||||||
1319431|NCT02316366|Secondary|Time to Disposition|The amount of time spent in the ED was recorded for each patient|4 hours||||minutes||95% Confidence Interval|Mean
1314791|NCT02437513|Secondary|Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score|"In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score:~0 = None~= Mild, some difficulty~= Moderate Difficulty but can continue~= Severe difficulty, cannot continue"|1 weeks|Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.|||participants|||Number
1314792|NCT02437513|Secondary|Number of Reported Adverse Events|Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period|2 weeks||||AE reported|||Number
1314793|NCT02437513|Secondary|Number of Reported Adverse Events|Analysis of the reported system or procedure related adverse events using standard AE reporting form|at device implantation||||adverse events|||Number
1314794|NCT02437513|Primary|Change From Baseline Per Patient of Number and Severity of Aspiration Events|In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12|12 weeks|First patient: Device was explanted within 48 hours after implantation - no Data could be collected Second Patient: Due to patient's non-compliance no data could be collected.Device was explanted within two weeks after implantation.||||||
1314795|NCT02437487|Secondary|Number of Subjects With CDI Recurrence||24 Weeks|Intention-to-Treat (ITT) Population|||Participants|||Count of Participants
1314796|NCT02437487|Secondary|Number of Subjects With CDI Recurrence||12 Weeks|Intention-to-Treat (ITT) Population|||Participants|||Count of Participants
1314797|NCT02437487|Secondary|Number of Subjects With CDI Recurrence||4 Weeks|Intention-to-Treat (ITT) Population|||Participants|||Count of Participants
1314798|NCT02437487|Secondary|Time to Recurrence of CDI|Kaplan-Meier estimate of median number of days to recurrence|Recurrence of CDI up to 24 weeks after treatment.|Intention to Treat (ITT) Population|||days||95% Confidence Interval|Median
1314799|NCT02437487|Primary|Number of Subjects With CDI Recurrence||8 weeks after treatment.|Intention-To-Treat (ITT) Population|||participants|||Number
1314800|NCT02437409|Secondary|No. of Passages Needed to Reach the Final TICI Score With pREset||during intervention, up to 3 hr|100 patients harboured 109 vessel occlusions|||passes|vessel occlusions|Standard Deviation|Mean
1314801|NCT02437409|Secondary|Recanalization of the Target Vessel|"original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging.~Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion."|at the end of intervention, up to 3 hr|100 patients harboured 109 vessel occlusions|||number of vessels|vessel occlusions||Number
1314802|NCT02437409|Secondary|Time From Groin Puncture to Recanalization||during intervention, up to 3 hr|All Patients|||minutes||Full Range|Median
1314803|NCT02437409|Secondary|Intracranial Hemorrhage (ICH)|Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.|24 hr after treatment|All Patients|||patients|||Number
1314804|NCT02437409|Secondary|Neurological Condition of the Patient|"The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are:~Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2)~Best Gaze (0-2)~Visual (0-3)~Facial palsy (0-3)~Motor arm (0-4)~Motor leg (0-4)~Limb ataxia (0-2)~Sensory (0-2)~Best Language (0-3)~Dysarthria (0-2)~Extinction and Inattention (0-2)~CLASSIFICATION:~0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke~As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf"|24 to 72 hr after treatment|All Patients|||NIHSS score||Full Range|Median
1314805|NCT02437409|Primary|Neurological Condition of the Patient|"modified Rankin Scale (mRS)~Neurological Condition is measured by the Modified Rankin Scale (mRS). This scale ranges from 0 - 6:~0 = No symptoms at all;~= able to carry out all usual duties and activities;~= unable to carry out all previous activities, but able to look after own affairs without assistance;~= requiring some help, but able to walk without assistance;~= unable to walk without assistance and unable to attend to own bodily needs without assistance;~= bedridden, incontinent and requiring constant nursing care and attention;~= dead"|90 days after treatment|All Patients|||patients|||Number
1314806|NCT02437344|Secondary|Withdrawal: Subjective Opioid Withdrawal Scale Scores at Baseline and Administered Subsequently||5 weeks|||||||
1314807|NCT02437344|Primary|Successful Naltrexone Initiation|The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX|2 weeks||||Participants|||Count of Participants
1314808|NCT02437305|Primary|Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention|The subject will complete 3 questionnaires: one pre-intervention, one post-intervention, and one 2 months post-intervention. Several questions will assess the participants knowledge of general melanoma, what it looks like and what are its risk factors. To determine participant retention, the pre-intervention and 2 month post-intervention questionnaires will be evaluated.|2 months post-intervention||||participants|||Number
1314809|NCT02437305|Primary|Number of Participants That Performed Regular Self-Skin Examinations|The subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 5 questions will assess whether or not the patient has completed skin-self examinations and knows which areas of the skin to pay attention to. The pre-intervention and 2 month post-intervention questionnaire will be evaluated to determine the number of participants that performed regular self-skin examinations.|2 months post-intervention||||participants|||Number
1314810|NCT02437253|Secondary|Anti-ERT Antibodies|Anti-laronidase antibodies for subjects with MPS I. Anti-idursulfase antibodies for subjects with MPS II.|Day 0 to week 16 of treatment with adalimumab versus placebo|No participants had anti-ERT antibodies|||Participants|||Count of Participants
1314811|NCT02437253|Secondary|Range of Motion - Bilateral Shoulder, Elbow, Hip, Knee|Number of joints with a >5 degree more positive change during 16 weeks of adalimumab versus 16 weeks of placebo. A total of eight joints were measured.|Day 0 to week 16 of treatment with adalimumab versus placebo||||joints|||Number
1314812|NCT02437253|Secondary|Pain Measured by the Visual Analog Scale (VAS) in the Pediatric Pain Questionnaire (PPQ)|"Percent of participants with a >10 mm improvement in either how you feel now or worst pain you had this week on the VA in the PPQ during adalimumab versus during placebo by either parental or subject report. Range is 0-100 mm; lower number means less pain."|Day 0 to week 16 of treatment with adalimumab versus placebo||||Participants|||Count of Participants
1314813|NCT02437253|Secondary|Children's Health Questionnaire - Parent Form 50 Physical Function (PF) Standardized Score|Children's Health Questionnaire - Parent Form 50 physical function (PF) standardized score for participants < 18 years of age. Range is from 0 to 100 (no units) and standardization if determined by comparison to healthy age matched children. Lower values mean decreased physical function. The difference of change in PF standardized score from day 0 to week 16 during adalimumab treatment minus change in PF standardized score from day 0 to week 16 during placebo treatment is reported.|Day 0 to week 16 of treatment with adalimumab versus placebo||||units on a scale||Full Range|Mean
1314814|NCT02437253|Primary|Children's Health Questionnaire - Parent Form 50 Bodily Pain Standardized Score|Children's Health Questionnaire - Parent Form 50 bodily pain (BP) standardized score for participants < 18 years of age. Range is from 0 to 100 (no units) and standardization if determined by comparison to healthy age matched children. Lower values mean increased pain. The difference of change in BP standardized score from day 0 to week 16 during adalimumab treatment minus change in BP standardized score from day 0 to week 16 during placebo treatment is reported.|day 0 to week 16 of treatment with adalimumab versus placebo|This was a cross-over study so within-individual changes are reported.|||units on a scale||Full Range|Mean
1314815|NCT02437162|Primary|Percentage of Participants Who Achieved an Assessment In Ankylosing Spondylitis (ASAS) 40 Response at Week 24|ASAS 40 is defined as improvement of greater than or equal to (>=) 40 percent (%) from baseline and absolute improvement from baseline of at least 2 on a 0 to 10 centimeter (cm) scale in at least 3 of the following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well, 10=very poor), Total back pain (0 to 10 cm; 0=no pain, 10=most severe pain), Function (self-assessment represented as a mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none, 10=very severe); and absence of deterioration (no worsening at all from baseline in the remaining domain) from baseline in the potential remaining domain.|Week 24|The full analysis set (FAS) included all participants who were randomized and received at least one administration of study agent.|||Percentage of participants|||Number
1314816|NCT02436811|Primary|Changes in the Knowledge Score|The knowledge score was assessed by nine statements developed and tested in a pilot study including items related to breastfeeding, supplemental feeding, sugar intake, bottle use, oral hygiene, and use of fluoride toothpaste. These statements were rated on a three-level Likert scale, under the following options: “agree,” “neither agree nor disagree,” and “disagree,” in addition to “I don’t know.” Each correct answer received score 1 whereas incorrect answers such as “neither agree nor disagree” and “I don’t know” were assigned score 0. The final scores ranged from 0 to 9. Higher values indicate better outcomes.|The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.||||units on a scale||Standard Deviation|Mean
1314817|NCT02436577|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
1314818|NCT02436577|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
1314819|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs i.e. Pulse (beats per minute [bpm]) were collected after the participant has rested in the supine position for at least 5 minutes.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart) and during treatment periods at pre-dose and post-dose at 2, 4 and 24 hours.|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||bpm||Standard Deviation|Mean
1314820|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP)|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (pre dose, 2 hours, and 4 hours post dose) and Day 2 (24 hours post dose).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||mmHg||Standard Deviation|Mean
1314833|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed again by participants in the Experimental group at 1 year. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from 6 month shuttle run at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Shuttle run was completed by 20/35 participants in the Experimental group at both 6 months and 1 year. Available data was analyzed."|||number of runs||95% Confidence Interval|Mean
1314916|NCT02434497|Secondary|Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline TC|participants|95% Confidence Interval|Geometric Mean
1314821|NCT02436577|Secondary|Elimination Rate Constant (Kel) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of kel (elimination rate constant) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||1/hour||Standard Deviation|Geometric Mean
1314822|NCT02436577|Secondary|Number of Participants With Adverse Events (AEs)|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|From the date of randomization (Day 1 of the first treatment period) until the final follow-up visit (5 to 10 days after last administration of IMP).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||Participants|||Number
1314823|NCT02436577|Secondary|Ratio of Metabolite AUC to Parent AUC, Adjusted for Differences in Molecular Weights (MRAUC) of Active Metabolite AR-C124910XX|Assessment of MRAUC (Ratio of metabolite AUC to parent AUC, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1314824|NCT02436577|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC [0-t]) of Active Metabolite AR-C124910XX|Assessment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1314825|NCT02436577|Secondary|MRCmax (Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights) of Active Metabolite AR-C124910XX|Assessment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1314826|NCT02436577|Secondary|Mean Residence Time (MRT) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of MRT (mean residence time) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||hours||Standard Deviation|Geometric Mean
1314834|NCT02436330|Secondary|Heart Rate Change||Change from 6 month Heart rate at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Heart rate data was collected at 6 month and 1 year for 27/35 of the participants. Available data was analyzed."|||beats per minute||95% Confidence Interval|Mean
1319432|NCT02316366|Secondary|Pain Score|During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided.|4 hours|||||||
1314827|NCT02436577|Secondary|Terminal Elimination Rate Constant (λz) of Ticagrelor and Its Active Metabolite, AR-C124910XX.|Comparison of terminal elimination rate constant (λz) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||1/hour||Standard Deviation|Mean
1314828|NCT02436577|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of t½λz (half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||hours||Standard Deviation|Mean
1314829|NCT02436577|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of tmax (Time to reach maximum observed concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||hours||Full Range|Median
1314830|NCT02436577|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC (Area under plasma concentration-time curve from zero to infinity) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1314831|NCT02436577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration AUC (0-t) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC(0-t) (Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314832|NCT02436577|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of Cmax (maximum observed plasma concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the orodispersible (OD) tablet - when administered with and without water - and ticagrelor immediate-release (IR) tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The pharmacokinetic (PK) analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1314835|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from 6 month Systolic BP at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Systolic blood pressure was only documented at 6 months and 1 year for 27/35 of the participants. Available data is what was analyzed."|||mmHg||95% Confidence Interval|Mean
1314836|NCT02436330|Secondary|Waist Circumference Change||Change from 6 month waist circumference at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Only 25/35 participants had waist measurements collected at both 6 months and 1 year. Available data was analyzed."|||cm||95% Confidence Interval|Mean
1314837|NCT02436330|Secondary|Exergaming Program Component Influence on Attendance|"The experimental group will answer a questionnaire at the end of the 6 month study period, measuring the importance of specific components of the curriculum and motivators which influenced enrollment and compliance with participation. Of interest is measuring the influence of the exergaming curriculum as compared to these other factors. This is a 16-item, 3-point Likert-scale (1 = least important and 3 = most important) questionnaire created specifically for this study. Results were reported based on % of participants rating 3 ,most important, for each curriculum component."|6 months||||percentage of subjects|||Number
1314838|NCT02436330|Secondary|Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of sugar sweetened beverages per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 27/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding sugar sweetened beverage daily intake. Analysis was completed on the available data.|||servings||Standard Deviation|Mean
1314839|NCT02436330|Secondary|Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of fruit servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily fruit intake. Analysis was completed on the available data.|||Servings||Standard Deviation|Mean
1314840|NCT02436330|Secondary|Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of vegetable servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily vegetable intake. Analysis was completed on the available data.|||servings||Standard Deviation|Mean
1314841|NCT02436330|Secondary|Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total % dietary carbohydrates is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding %carbohydrates in their daily diet. Analysis was completed on the available data.|||percentage of carbohydrates||Standard Deviation|Mean
1314842|NCT02436330|Secondary|Change in Dietary Intake: % Fat (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total %dietary fat intake per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding the %fat in their daily diet. Analysis was completed on the available data.|||percentage of fat||Standard Deviation|Mean
1314843|NCT02436330|Secondary|Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total kcal/kg/day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response. Analysis was completed on the available data.|||kcal/day||Standard Deviation|Mean
1314844|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Global Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline to 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.|||scores on a scale||Standard Deviation|Mean
1314845|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Physical Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline at 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.|||scores on a scale||Standard Deviation|Mean
1314897|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones||96 weeks||||participants|participants||Number
1314846|NCT02436330|Secondary|Activity Levels Measured by Pedometers (Weekly Steps)|Activity will be measured by pedometers (number of steps) during week 1 and week 24 for both groups. Subjects used the Yamax 200 pedometer to count the steps they took over 1 weeks time.|Change from week 1 to week 24|Missing data: Data was not available from all participants from pedometer use at both the 1 week and 24 week mark, therefore, this analysis only includes 13/35 participant data from the Experimental group and 10/13 participant data collected from the Active comparator group.|||steps||Standard Deviation|Mean
1314847|NCT02436330|Secondary|Saturday Screen Time as Assessed by Questionnaire|Change in Saturday screen time (reported out as fraction of an hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. Saturday screen time was defined as the amount of time spent on any screen, on an average Saturday, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change in hours from baseline at 6 months|"Missing Data: Survey data regarding Saturday screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."|||hours||Standard Deviation|Mean
1314848|NCT02436330|Secondary|After School Screen Time as Reported on Questionnaire|Change in after school screen time (reported out as fraction of 1 hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. After school screen time was defined as the amount of time spent on any screen, on the average weekday afternoon/evening, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change from baseline at 6 months|"Missing Data: Survey data regarding after school screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."|||hours||Standard Deviation|Mean
1314849|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed by participants at baseline (session 1) and at 6 months. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from baseline shuttle run at 6 months|Missing Data: Shuttle run was completed by participants at baseline and at 6 months to document the change in number of runs. Not all participants attended the 6 month measurement visit, therefore, complete data was only available on 24/35 of the Experimental group and 13/13 of the Active comparator group. Available data was analyzed.|||number of runs||Standard Deviation|Mean
1314850|NCT02436330|Secondary|Heart Rate Change From Baseline to 6 Months||Change from baseline at 6 months|Missing Data: Heart rate measurements at baseline and at 6 months was only available for 33/35 Experimental group participants and 12/13 Active comparator group participants. Not all participants attended the 6 month measurement/data collection visit.|||beats per minute||Standard Deviation|Mean
1314851|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from baseline Systolic BP at 6 months|Incomplete data available for analysis. Blood pressure was taken and documented at baseline and at 6 months, however, not all participants were in attendance. Complete data was only available for 33/35 Experimental group participants and 12/13 from the Active comparator group. Available data was analyzed.|||mmHg||Standard Deviation|Mean
1314852|NCT02436330|Secondary|Waist Circumference Change||Change from baseline at 6 months|Incomplete data available for analysis. Change in waist circumference from baseline to 6 month measurements was only collected on 34/35 of the Experimental group and 8/13 of the Active comparator group. The other participants did not show up for the 6 month measurements.|||cm||Standard Deviation|Mean
1314853|NCT02436330|Primary|BMI Z-score Change|Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).|Change from baseline BMI z-score at 1 year|Complete data was not available for all 35 subjects for this outcome measure. BMI z-score change from baseline to 1 year was only collected on 28 of the 35 participants.|||z-score||95% Confidence Interval|Mean
1314854|NCT02436330|Primary|BMI Z-score Change|All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).|Change from baseline at 6 months||||z-score||Standard Deviation|Mean
1314855|NCT02436304|Secondary|Time to Cessation of Otorrhea|The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Up to Day 14|ITT analysis set|||days||95% Confidence Interval|Median
1314856|NCT02436304|Secondary|Percentage of Subjects With Microbiological Success at Day 14|Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 14|This analysis population includes all ITT participants who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set)|||percentage of participants|||Number
1314857|NCT02436304|Primary|Percentage of Subjects With Sustained Clinical Cure at Day 8|Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 8|ITT analysis set|||percentage of participants|||Number
1314858|NCT02436031|Secondary|Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep|The AHI is the number of apneas (pauses in breathing) or hypopneas (shallow breathing) recorded during the study per hour of sleep. Data for the calculation of the AHI was collected while the participant was in NREM sleep in the supine position and off CPAP (breathing spontaneously).|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.|||events per hour||Inter-Quartile Range|Median
1314859|NCT02436031|Secondary|Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings|Electromyography (EMG) was used to analyze genioglossus (GG) [EMG GG] muscle activity. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus muscle (tongue). Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness) (%max/cmH2O).|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.|||%max/cmH2O||Inter-Quartile Range|Median
1314860|NCT02436031|Primary|Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility|Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are passive; Active Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are active. Improved=more negative Pcrit.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.|||cm H2O||Inter-Quartile Range|Median
1314861|NCT02435966|Secondary|Change in the Neck Disability Index Questionnaire||Pre-intervention (Day 1); after 2nd intervention (7 days)|||||||
1314862|NCT02435966|Secondary|Change in the Cervical Range of Motion Measured by Goniometer|Measured by goniometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)|||||||
1314863|NCT02435966|Secondary|Change in the Pressure Pain Threshold Measured by Algometer|Measured by algometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)|||||||
1314864|NCT02435966|Primary|Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days|The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)||||units on a scale||Standard Deviation|Mean
1314865|NCT02435836|Primary|Percentage of Participants With Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Percentage of participants|||Number
1314866|NCT02435836|Primary|Percentage of Participants With ECG Measurements of Potential Clinical Relevance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Percentage of participants|||Number
1314867|NCT02435836|Primary|Percentage of Participants With Vital Signs of Potential Clinical Relevance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||percentage of participants|||Number
1314868|NCT02435836|Primary|Number of Participants With Adverse Events (AEs)|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial.|Baseline to Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Participants|||Number
1314869|NCT02435836|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314870|NCT02435836|Primary|Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week|BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314871|NCT02435836|Primary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week|The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314872|NCT02435836|Primary|Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, >34 = severe depression.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314873|NCT02435836|Primary|Mean Clinical Global Impression of Improvement (CGI-I) by Week|"The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5~=minimally worse; 6 = much worse; and 7 = very much worse."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314874|NCT02435836|Primary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314875|NCT02435836|Primary|Mean Change From Baseline in PANSS Negative Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314876|NCT02435836|Primary|Mean Change From Baseline in PANSS Positive Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314898|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN||96 weeks||||participants|participants||Number
1314899|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN||96 weeks||||participants|participants||Number
1314900|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN||96 weeks||||participants|participants||Number
1314877|NCT02435836|Primary|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
1314878|NCT02435277|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E). Based on the pre-specified mixed model inferential statistical analysis, there was an apparent dose-dependent relationship for the mean decrease from baseline in fasting plasma glucose for the fixed dose leucine amd metformin combination treatments A, B and C.|Baseline and 12 weeks|Mixed Model Inferential Statistical Analysis of Fasting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)|||mg/dL||Standard Deviation|Mean
1314879|NCT02435277|Primary|Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations|Change in HbA1c from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E) in subjects receiving various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy.|Baseline and 12 weeks|Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)|||percent HbA1c||Standard Deviation|Mean
1314880|NCT02434939|Secondary|Incidence of Treatment Failure by Treatment Group.|Requiring more than two doses of the study medication provided for adequate pain control|120 minutes||||participants|||Number
1314881|NCT02434939|Secondary|Incidence of Side Effects, Including Outlying Vital Signs|The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), Ramsay Sedation Scale (RSS) score at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. outlying vital signs recorded.( systolic Blood pressure less than 90mmHg or greater than 150mmHg, Heart rate less than 50bpm or greater than 150bpm, oxygen saturation below 90%, respiratory rate below 9breaths/minute or greater than 40breaths/minute and RSS of 1 or greater than 3) The RSS was used to asses the level of agitation or sedation caused by the intervention .the scale ranges from 1(anxious/agitated) to 6( no response to stimulus-deep sedation) with 2 being the optimal (cooperative, oriented and tranquil).A checklist for side effects like airway problems, allergic reactions, salivation, dysphoria,nystagmus, respiratory/cardiac arrest, awakening hallucinations, nausea/vomiting was used|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration||||participants|||Number
1314882|NCT02434939|Secondary|Time to Maximal Analgesic Effect and Duration of Action of Ketamine|"Following dosage with study medication, the amount of time taken to demonstrate the maximal change in the patient's NRS pain score.~Maximal change in NRS pain score is to be defined as the largest change from patient's baseline pain score. Duration of maximal change is how long the patient's pain score remained at this level."|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration||||minutes||Standard Deviation|Mean
1314883|NCT02434939|Primary|Maximal Change in NRS Pain Scores as a Percentage of Baseline NRS Pain Score.|Our primary outcome measurement was the maximum change on the verbal NRS pain scale compared with their initial score (baseline). The NRS was used to measure a patient's subjective level of pain on a scale from 0 (representing no pain at all) to 10 (the worst pain imaginable) using whole numbers. The NRS score was documented just prior to the administration of the study drug (time zero). After infusion of the study drug was complete, NRS scores were documented at 5, 10, 20, and then every 20 minutes thereafter up to 120 minutes. We stopped recording NRS scores prior to 120 minutes if the patient requested a third dose of the study drug, withdrew consent or developed a severe adverse effect.|5, 10, 20,25,30, 40,45,50 60, 80, 100, 120 minutes post drug adminstration|3 patients in ketamine arm withdrew consent after 20 minutes in to the study while 1 patient in morphine arm was discontinued due to urticarial for fear of a worsened reaction if reexposed to the drug as he required a second dose|||percent change from baseline NRS score.||Standard Deviation|Mean
1314884|NCT02434523|Secondary|Lost to Follow up||8 weeks|number of subjects in each arm who were lost to follow up|||participants|||Number
1314885|NCT02434523|Secondary|Side Effects|number of patients with side effects, type of side effects|8 weeks||||participants|||Number
1314886|NCT02434523|Secondary|Voice Handicap Index|Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes|8 weeks||||units on a scale||Standard Deviation|Mean
1314887|NCT02434523|Primary|Reflux Symptom Index|Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes|8 weeks|Patients who completed treatment and post-treatment questionnaire|||units on a scale||Standard Deviation|Mean
1314888|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Vital Signs||96 weeks||||participants|participants||Number
1314889|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Skin||96 weeks||||participants|participants||Number
1314890|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities||96 weeks||||participants|participants||Number
1314891|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck||96 weeks||||participants|participants||Number
1314892|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance||96 weeks||||participants|participants||Number
1314893|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular||96 weeks||||participants|participants||Number
1314894|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal ECG, Abnormalities||96 weeks||||participants|participants||Number
1314895|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein||96 weeks||||participants|participants||Number
1314896|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood||96 weeks||||participants|participants||Number
1314938|NCT02434497|Primary|Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score)|Height z-score is a dimensionless quantity derived by subtracting the population mean from the individual raw score, and then deviding the difference by the pouulation SD of the reference population. This indicates how many SDs and observation is above or below the general population mean.|96 weeks||||standard deviations|participants|Standard Deviation|Mean
1314939|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation||96 weeks||||participants|||Number
1314940|NCT02434497|Primary|Safety and Tolerability in Terms of Growth, Height||96 weeks||||cm|participants|Standard Deviation|Mean
1314941|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN)||96 weeks||||participants|participants||Number
1314942|NCT02434497|Primary|Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events||96 weeks||||participants|||Number
1314943|NCT02434497|Primary|The Number of Participants Who Experianced Adverse Events and Serious Adverse Events||96 weeks||||participants|||Number
1314944|NCT02434471|Primary|Noise Scores|Three investigators will independently evaluate MRI examinations. They will assign noise scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no noise artifact; 2 = minimal noise artifact, no effect on diagnostic quality; 3 = moderate noise artifact with some, but not severe, effect on diagnostic quality; 4 = severe noise artifact, images degraded but interpretable; and 5 = severe noise artifact, images nondiagnostic.|During MRI, up to 60 minutes|The same 25 subjects were used for each group.|||scores on a scale||Standard Deviation|Mean
1314945|NCT02434471|Primary|Motion Artifact Scores|Three investigators will independently evaluate MRI examinations. They will assign motion scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no motion artifact; 2 = minimal motion artifact, no effect on diagnostic quality; 3 = moderate motion artifact with some, but not severe, effect on diagnostic quality; 4 = severe motion artifact, images degraded but interpretable; and 5 = extensive motion artifact, images nondiagnostic.|During MRI, up to 60 minutes|The same 25 subjects were used in both groups.|||scores on a scale||Standard Deviation|Mean
1314946|NCT02434146|Primary|Time to Onset of Grade 3 Oral Mucositis|Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.|Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 3 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and time to onset of grade 3 oral mucositis could not be analyzed.||||||
1314947|NCT02434146|Primary|Time to Onset of Grade 2 Oral Mucositis|Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.|Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 2 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and time to onset of grade 2 oral mucositis could not be analyzed.||||||
1314948|NCT02434146|Primary|Recommended Phase IIa Dose|The dose of topical phenylephrine solution which will be recommended for a larger follow-up phase II efficacy study will be established after the dose cohort at the MTD has been expanded to a total of 12 patients.|During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the dose of topical phenylephrine solution for a larger follow-up phase II efficacy study could not be recommended.||||||
1314949|NCT02434146|Primary|Maximum Tolerated Dose (MTD), Defined as the Highest Dose Level of Phenylephrine Applied to the Oral Mucosa Where 0/3, 0/6, or 1/6 Patients Experience a Dose-limiting Toxicity|Determine Maximum Tolerated Dose (MTD), the highest dose level of phenylephrine applied to the oral mucosa|During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and MTD could not be determined.||||||
1314950|NCT02434146|Primary|Incidence of Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0|Adverse events (AEs) will be presented in the summary tables by preferred term nested within the System Organ Class. Verbatim description, preferred term, and system organ class for all AEs will be contained in the patient data listings. All AEs occurring after enrollment and throughout the study period will be recorded. Each toxicity event will be assigned an attribution: unrelated, unlikely, possibly, probably, or definitely phenylephrine treatment related.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and no study conclusions could be made.||||||
1314951|NCT02434146|Primary|Efficacy Response Rate for Preventing Oral Mucositis With Sufficient Accuracy|If a patient experiences no higher than grade 2 oral mucositis, then s/he will be defined as a responder. If a patient experiences grade >= 3 oral mucositis, s/he will be defined as a non-responder. Specifically, the efficacy response rate will be estimated with a standard error of less than 15% and the length of the 95% confidence interval will be less than 50%. The efficacy response rate will be summarized in tabular format. The Wilson score method will be used to calculate the 95% confidence interval for the efficacy response rate for the extended cohort.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the efficacy response rate could not be estimated.||||||
1314952|NCT02434146|Primary|Duration of Grade 3 Oral Mucositis|If the grade 3 oral mucositis has not been resolved (to a grade < 3) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.|Date of onset of grade 3 oral mucositis to the date of resolution to grade < 3 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the median duration of oral mucositis could not be analyzed.||||||
1314953|NCT02434146|Primary|Duration of Grade 2 Oral Mucositis|If the grade 2 oral mucositis has not been resolved (to a grade < 2) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.|Date of onset of grade 2 oral mucositis to the date of the resolution of the grade 2 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the median duration of oral mucositis could not be analyzed.||||||
1314954|NCT02434146|Primary|Area Under the Curve (AUC) for the Oral Mucositis Severity|The mucositis AUC will be estimated using the trapezoid method and summarized in terms of means, standard deviation, median and range. This analysis will be performed in both the extended cohort as well as in the historical controls.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and AUC could not be estimated or analyzed.||||||
1314955|NCT02433834|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) on Day 15|The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population. The modified intent-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they received.|||Scores on a scale||Standard Error|Least Squares Mean
1314956|NCT02433834|Secondary|Change From Baseline in Average Daily Rescue Medication Use Over 14 Days|Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Puffs||Standard Error|Least Squares Mean
1314957|NCT02433834|Secondary|Change From Baseline in Average Daily Post-dose PEFR Over 14 Days|Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||L/min||Standard Error|Least Squares Mean
1314958|NCT02433834|Secondary|Change From Baseline in Average Daily Pre-dose PEFR Over 14 Days|Change from baseline in average daily pre-dose peak expiratory flow rate (PEFR) over 14 days Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||L/min||Standard Error|Least Squares Mean
1314959|NCT02433834|Secondary|FEV1 AUC0-3 on Day 15|FEV1 AUC0-3 is the area under the curve for the change from baseline in FEV1 calculated using the trapezoidal rule. All observed data will be used with the trapezoidal rule to calculate AUC. To aid in interpretation, all AUC values will be normalized by dividing the AUC by the time from the first to the last non-missing value (typically 3 hours).|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Liter||Standard Error|Least Squares Mean
1314960|NCT02433834|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 on Day 15|Change from baseline in morning pre-dose trough FEV1 on Day 15|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Liter||Standard Error|Least Squares Mean
1314961|NCT02433834|Primary|Peak Change From Baseline in FEV1 Within 3 Hours Post-dosing on Day 15|Forced Expiratory Volume in 1 second (FEV1) within 3 hours post-dosing on Day 15|From Day 1 to Within 3 hours post dosing on Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Liter||Standard Error|Least Squares Mean
1314962|NCT02433496|Secondary|Average Morphine Equivalent Daily Dose (MEDD)|The average MEDD in milligrams for patients with consistent opioid Rx.|Up to 12 months|This is the number of patients who have a consistent opioid Rx.|||milligrams||Standard Deviation|Mean
1314963|NCT02433496|Secondary|Proportion With MEDD >120 mg|The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.|Up to 12 months|This is the number of patients who have a consistent opioid Rx.|||Proportion of participants|||Number
1314964|NCT02433496|Secondary|Intervention Cost|Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.|Up to 12 months|Four clinics were analyzed. No intervention was given to control group clinics, so there is no reported data.|||Dollars|clinics||Number
1314965|NCT02433496|Secondary|Intervention Fidelity|Total hours of coaching delivered/received among all clinics that received physician coaching.|Up to 12 months|Four clinics were analyzed for this measure. Since the intervention was specific to the physician coaching group, no time was spent in the Control group, thus there is no data to be reported.|||hours spent delivering implementation|clinics||Number
1314966|NCT02433496|Secondary|Participating Staff Characteristics|Characteristics of participating staff (profession)|Up to 12 months|These are clinic staff that made up the clinic change teams. Since change teams were specific to the physician coaching group, no change teams were constructed in the Control group, thus there is no data to be reported.|||Participants|||Count of Participants
1314967|NCT02433496|Secondary|Participating Clinic Characteristics|Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)|Up to 12 months||||participants|||Number
1314968|NCT02433496|Secondary|Participating Patient Demographics|Characteristics of participating patients vs. general patient population (race, gender, ethnicity)|Up to 3 years||||percentage of patients|||Number
1314969|NCT02433496|Secondary|Provider Drop-out Rate|Number and percentage of providers who drop out of study at 3 months|3 months|This is at the prescriber level.|||Participants|||Count of Participants
1314970|NCT02433496|Secondary|High-dose Patients|Proportion of opioid prescriptions above 120 mg daily morphine equivalent|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
1314971|NCT02433496|Secondary|Use of Pain Management Agreements|Proportion of opioid patients signing pain management agreements|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
1314972|NCT02433496|Secondary|Mental Health Screening Rate|Proportion of opioid patients screened for mental health/substance use problems|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
1314973|NCT02433496|Secondary|Urine Drug Screening Rate|Proportion of opioid patients completing urine drug screens prior to and during the study intervention|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
1314974|NCT02433496|Secondary|Rate of Opioid / Benzodiazepine Co-prescribing|Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
1314975|NCT02433496|Primary|Overall Rate of Opioid Prescribing|The proportion of patients with a chronic pain diagnosis receiving daily opioids.|Up to 3 years|This is the number of patients in each group.|||Proportion of patients|||Number
1314976|NCT02433483|Secondary|1-year Cumulative Incidence of Chronic Graft Versus Host Disease (GVHD)|All grades of GVHD will be reported.|From start of therapy through completion of therapy (approximately 1 year)|No patient survived long enough to evaluate chronic GVHD.||||||
1314977|NCT02433483|Other Pre-specified|Percent Donor Chimerism|Percent donor chimerism in blood and bone marrow.|At weeks 1, 2, 3, and 4 after infusion of HPC-A||||Percentage of donor chimerism||Full Range|Mean
1314978|NCT02433483|Secondary|1-year Cumulative Incidence of Acute Graft Versus Host Disease (GVHD)|"Children’s Oncology Group (COG) Stem Cell Committee Consensus Guidelines for Establishing Organ Stage and Overall Grade of Acute Graft Versus Host Disease (GVHD) were used. Overall clinical grade was based on the highest stage obtained:~Grade 0: no stage 1-4 of any organ~Grade I: stage 1-2 skin and no liver or gut involvement~Grade II: stage 3 skin, or stage 1 liver involvement, or stage 1 GI~Grade III: stage 0-3 skin, with stage 2-3 liver, or stage 2-3 GI~Grade IV: stage 4 skin, liver or GI involvement"|From start of therapy through completion of therapy (approximately 1 year)||||Participants|||Count of Participants
1314979|NCT02433483|Secondary|Time to Platelet Recovery|"The time to platelet recovery will be summarized using descriptive statistics. If there are no deaths prior to recovery of platelets, nonparametric confidence intervals for the median time to recovery will be computed by inverting the sign test. Otherwise, we will compute cumulative incidence curves to describe the time to platelet and neutrophil recovery while adjusting for competing events.~Due to the small number of patients enrolled, the data is presented by patient."|From start of therapy to completion of therapy (approximately 1 year)|Platelet recovery for Patient #1 could not be determined due to transfusions.|||days|||Number
1314980|NCT02433483|Secondary|Median Time to Neutrophil Recovery|The time to neutrophil recovery will be summarized using descriptive statistics. If there are no deaths prior to recovery of neutrophils, nonparametric confidence intervals for the median time to recovery will be computed by inverting the sign test. Otherwise, we will compute cumulative incidence curves to describe the time to platelet and neutrophil recovery while adjusting for competing events.|From start of therapy to completion of therapy (approximately 1 year)||||Days||Full Range|Median
1314981|NCT02433483|Secondary|3-year Overall Survival (OS)|We will use the Kaplan-Meier method to describe overall survival. Overall survival will be defined as the time from enrollment to death, with living subjects’ time censored at the date of last follow-up|3 years after enrollment of the last participant||||Percentage of participants|||Number
1314982|NCT02433483|Secondary|3-year Event Free Survival (EFS)|We will use the Kaplan-Meier method to describe event-free survival. EFS will be defined as the time from enrollment to death, relapse, or refractory disease with event-free subjects’ time censored at the date of last follow-up.|3 years after enrollment of the last participant||||Percentage of participants|||Number
1315040|NCT02433340|Secondary|Change From Baseline in CDAI at Week 4|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1314983|NCT02433483|Primary|Proportion of Participants Who Experience Therapeutic Success|"All patients will be counted towards this two-stage design. Therapeutic success for patients at time of enrollment is defined as:~Patients with fewer than 5% blasts, a ≥ 10-fold decrease in level of minimal residual disease after completion of 1 or 2 cycles of therapy.~Patients with greater than 5% in leukemic blasts in the marrow, achieving CR or CRi after completion of 1 or 2 cycles of therapy.~In terms of efficacy, patients who die before achieving therapeutic success will be counted as a failure, and all patients who receive ≥ 1 dose of protocol chemotherapy will be counted as a failure or success. Only subjects who withdraw or die prior to receiving the first dose of protocol chemotherapy will be considered inevaluable and replaced. The evaluation of tolerability and this phase II design will be performed concurrently, i.e., the first enrollees will be counted for both tolerability and efficacy."|At the end of therapy cycle 2 (approximately 2-3 months)||||proportion|||Number
1314984|NCT02433483|Primary|Number of Participants by Stratum Who Complete 2 Cycles of Therapy|If two or more patients die from causes other than leukemia progression or experience ≥ Grade 3 GVHD that is associated with detectable donor chimerism due to this protocol, or demonstrate persistent engraftment defined as >5% donor chimerism at the time of count recovery (ANC > 0.3 x 10^9/L and platelet count > 30 x 10^/L), then the cohort will close due to intolerability. Any subject who transfers to transplant prior to completion of two courses without experiencing an unacceptable toxicity is considered inevaluable for purposes of evaluating tolerability. Accrual will be halted for intolerability if there are two or more failures in tolerability among the first six subjects who are evaluable for tolerability.|At the end of therapy cycle 2 (approximately 2-3 months)||||Participants|||Count of Participants
1314985|NCT02433366|Primary|Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)|The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.|Day 1|AF patients on treatment with Pradaxa®.|||Percentage of Participants|||Number
1314986|NCT02433366|Primary|Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)|"The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.~This Outcome measure is applicable only for the Physicians group."|Day 1|Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)|||Percentage of Participants|||Number
1314987|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 36|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314988|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 32|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314989|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 28|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314990|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 24|Percentage of participants achieving CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314991|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 20|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314992|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 16|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314993|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 12|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314994|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 8|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314995|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 6|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314996|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 4|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314997|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 2|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315013|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 20|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314998|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 36|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1314999|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 32|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315000|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 28|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315001|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 24|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315002|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 20|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315003|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 16|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315004|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 12|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315039|NCT02433340|Secondary|Change From Baseline in CDAI at Week 6|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315005|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 8|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315006|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 6|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315007|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 4|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315008|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 2|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315009|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 36|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315010|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 32|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315011|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 28|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315012|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 24|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315202|NCT02431455|Primary|Hypoxia 6 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.|6 hours postoperative||||participants|||Number
1315014|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 16|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315015|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 12|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315016|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 8|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315017|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 6|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315018|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 4|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315019|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 2|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315020|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315021|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315230|NCT02430532|Secondary|Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)|The SDMT measures the time to pair abstract geometric symbols with specific numbers. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates a better outcome.|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315022|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315023|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315024|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315025|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315026|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315027|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315028|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315029|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315231|NCT02430532|Secondary|Percentage Change From Baseline to Week 108 in Whole Brain Volume|Whole brain volume is measured by magnetic resonance imaging (MRI).|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315030|NCT02433340|Secondary|Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315031|NCT02433340|Secondary|Change From Baseline in CDAI at Week 36|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315032|NCT02433340|Secondary|Change From Baseline in CDAI at Week 32|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315033|NCT02433340|Secondary|Change From Baseline in CDAI at Week 28|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315034|NCT02433340|Secondary|Change From Baseline in CDAI at Week 24|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315035|NCT02433340|Secondary|Change From Baseline in CDAI at Week 20|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315036|NCT02433340|Secondary|Change From Baseline in CDAI at Week 16|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315037|NCT02433340|Secondary|Change From Baseline in CDAI at Week 12|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315038|NCT02433340|Secondary|Change From Baseline in CDAI at Week 8|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1320509|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10||||% times patients had specific CGM/24-hr||Standard Error|Least Squares Mean
1315041|NCT02433340|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2|CDAI is a composite index for assessing disease activity based on the summation of the counts of Tender Joint Count 28 (TJC28) and Swollen Joint Count 28 (SJC28), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315042|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 36|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315043|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 32|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315044|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 28|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315045|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 24|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315046|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 20|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315047|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 16|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315048|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315049|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 8|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315050|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 6|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1320510|NCT02288273|Secondary|Change in HbA1c From Baseline to Day 22 and Baseline to Day 70||Day 22 and Day 70||||% Alc||Standard Error|Least Squares Mean
1315051|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 4|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315052|NCT02433340|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315053|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 36|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315054|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 32|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315055|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 28|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315056|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 24|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315057|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 20|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315058|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 16|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315059|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 12|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315060|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 8|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315061|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 6|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315062|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 4|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315063|NCT02433340|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
1315064|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 36|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315265|NCT02429791|Secondary|Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||mg/ Liter (L)||Standard Deviation|Mean
1315065|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 32|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315066|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 28|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315067|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315068|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 20|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315069|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 16|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315070|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 12|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315071|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 8|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315072|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 6|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315083|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315073|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 4|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315074|NCT02433340|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315075|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315076|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315077|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315078|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315079|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315080|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315081|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315082|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315281|NCT02429258|Secondary|Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
1315084|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315085|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315086|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315087|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315088|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315089|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315090|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315091|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315092|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315093|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315094|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315095|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315096|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315097|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 36|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315098|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 32|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315099|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 28|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315100|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 24|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315101|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 20|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315102|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 16|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315103|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 12|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315104|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 8|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315105|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 6|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315282|NCT02429258|Primary|Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
1315106|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 4|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
1315107|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 2|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had a baseline and post-baseline assessment. LOCF was used for missing data; LOCF imputation was conducted separately for M12-963 and M12-965 (ie, data from M12-963 was not carried forward to visits in M12-965).|||units on a scale||Standard Deviation|Mean
1315108|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 36|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315109|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 32|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315110|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 28|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315111|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 24|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315112|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 20|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315113|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 16|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315369|NCT02423993|Secondary|Glycaemic Variability|"Several glucose variability scores was assessed: SD, MAGE, MODD, LI, HBGI, LBGI, MAG. For SAP users glucose variability scores were calculated from CGM data. For CSII users with SMBG only glucose variability scores were calculated from bolus calculator (Bolus Wizard) data."|within 4 month of the study||2015-11-30|11/2015||||
1315114|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 12|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315115|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 8|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315116|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 6|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315117|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 4|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315118|NCT02433340|Secondary|Change From Baseline in Swollen Joint Count (SJC66) at Week 2|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
1315119|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 36|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315120|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 32|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315137|NCT02433340|Primary|ACR70 Response Rate at Week 12|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315121|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 28|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315122|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 24|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315123|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 20|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315124|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 16|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315125|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 12|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315126|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 8|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315127|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 6|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315138|NCT02433340|Primary|ACR70 Response Rate at Week 8|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315128|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 4|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315129|NCT02433340|Secondary|Change From Baseline In Tender Joint Count (TJC68) at Week 2|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
1315130|NCT02433340|Primary|Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965.|||Participants|||Count of Participants
1315131|NCT02433340|Primary|ACR70 Response Rate at Week 36|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315132|NCT02433340|Primary|ACR70 Response Rate at Week 32|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315133|NCT02433340|Primary|ACR70 Response Rate at Week 28|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315134|NCT02433340|Primary|ACR70 Response Rate at Week 24|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315135|NCT02433340|Primary|ACR70 Response Rate at Week 20|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315136|NCT02433340|Primary|ACR70 Response Rate at Week 16|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1320511|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10||||mg/dL||Standard Error|Least Squares Mean
1315139|NCT02433340|Primary|ACR70 Response Rate at Week 6|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315140|NCT02433340|Primary|ACR70 Response Rate at Week 4|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315141|NCT02433340|Primary|ACR70 Response Rate at Week 2|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315142|NCT02433340|Primary|ACR50 Response Rate at Week 36|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315143|NCT02433340|Primary|ACR50 Response Rate at Week 32|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315144|NCT02433340|Primary|ACR50 Response Rate at Week 28|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315145|NCT02433340|Primary|ACR50 Response Rate at Week 24|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315146|NCT02433340|Primary|ACR50 Response Rate at Week 20|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315147|NCT02433340|Primary|ACR50 Response Rate at Week 16|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315148|NCT02433340|Primary|ACR50 Response Rate at Week 12|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315149|NCT02433340|Primary|ACR50 Response Rate at Week 8|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315150|NCT02433340|Primary|ACR50 Response Rate at Week 6|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315151|NCT02433340|Primary|ACR50 Response Rate at Week 4|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315152|NCT02433340|Primary|ACR50 Response Rate at Week 2|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315153|NCT02433340|Primary|ACR20 Response Rate at Week 36|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315154|NCT02433340|Primary|ACR20 Response Rate at Week 32|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315155|NCT02433340|Primary|ACR20 Response Rate at Week 28|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315156|NCT02433340|Primary|ACR20 Response Rate at Week 24|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315157|NCT02433340|Primary|ACR20 Response Rate at Week 20|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315158|NCT02433340|Primary|ACR20 Response Rate at Week 16|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315159|NCT02433340|Primary|ACR20 Response Rate at Week 12|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315160|NCT02433340|Primary|ACR20 Response Rate at Week 8|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315161|NCT02433340|Primary|ACR20 Response Rate at Week 6|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315162|NCT02433340|Primary|ACR20 Response Rate at Week 4|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315163|NCT02433340|Primary|American College of Rheumatology (ACR) 20 Response Rate at Week 2|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. Last observation carried forward (LOCF) was used for missing data.|||percentage of participants||95% Confidence Interval|Number
1315164|NCT02432300|Secondary|State Trait Anxiety Inventory (STAI)|The STAI is a self-report measure of state and trait anxiety (20 items each). The trait anxiety subscale was the variable of interest for this study. Higher scores indicate more trait or state anxiety. Scores for each scale range from 20-80, with higher scores indicating greater anxiety. The raw scores were converted into T scores using age and gender norms provided by the authors for the STAI. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Higher T scores were still indicative of higher anxiety. We reported T scores for trait anxiety.|Week 6||||units on a scale||Standard Deviation|Mean
1315165|NCT02432300|Secondary|Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression|The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the DSM-IV signs and symptoms of major depression. The 9 items describe problems associated with depression, and participants must rate how often they have been bothered by the problems in the last 2 weeks on a 0-3 scale. The scores are summed for a total depression score, ranging from 0-27, which higher scores indicating greater depression.|Week 6||||units on a scale||Standard Deviation|Mean
1315166|NCT02432300|Primary|Levels of Emotional Awareness Scale (LEAS)|The LEAS is comprised of ten hypothetical scenarios that are three or four sentences in length. Participants must respond how they think they would feel and how another person would feel in response to the hypothetical scenario. The more discrete emotions (e.g., bad vs sad) receive higher points, as well as blended emotions (e.g. sad and angry). There are 10 items on this measure. The minimum score for each item is 0 and the max score for each item is 5. The item scores are summed to calculate a total score. Thus, the total scores range from 0-50; 0=lowest awareness and 50=highest awareness. A computerized scoring system and parallel forms were used.|Week 6||||units on a scale||Standard Deviation|Mean
1315167|NCT02432300|Primary|Toronto Alexithymia Scale-20 (TAS-20)|This is a 20-item self-report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing Feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher alexithymia). Subscales are summed to compute a total score Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.|Week 6||||units on a scale||Standard Deviation|Mean
1315168|NCT02432287|Secondary|Mixed Meal Tolerance. Assessment of Insulin Sensitivity and Insulin Secretion (Using a Modification of the Matsuda Index)|Assessment of insulin sensitivity and insulin secretion. Insulin sensitivity will be estimated from insulin and glucose levels obtained following the standard meal challenge, using a modification of the Matsuda index, which has been widely used for non-invasive assessment of insulin sensitivity and shows good correlation (r=0.73) with results obtained from euglycemic hyperinsulinemic clamp studies. A higher Matsuda index indicates better insulin sensitivity. The insulin sensitivity index (ISI (comp) was calculated using the following equation (where g denotes glucose at various time points and i denotes insulin at various time points): ISI (comp)= 10000/ ((g0*i0* ((g0*15+ g30*30+ g60*30+ g90*30+ g120*30+ g180*30+ g240*15)/240))* ((i0*15+ i30*30+ i60*30+ i90*30*+ i120*30+ i180*30+ i240*15)/240))^0.5|6 weeks||||index||Standard Deviation|Mean
1315169|NCT02432287|Primary|Increase in Number of Expressed Genes in Muscle and Adipose Tissue Using RNA Sequencing (RNA-Seq)|The investigators hypothesize that treatment with metformin will result in changes in the transcriptome. The investigators will test this by identifying increases in gene expression in muscle and adipose tissue with RNA Sequencing (RNA-Seq) in metformin and in placebo.|6 weeks||||genes|||Number
1315170|NCT02432105|Secondary|Time to Cessation of Otorrhea|Time (in days) to the cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Up to Day 14|ITT analysis set|||days||95% Confidence Interval|Median
1315200|NCT02431455|Primary|Hypoxia 24 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.|24 hours postoperative||||participants|||Number
1315201|NCT02431455|Primary|Hypoxia 12 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.|12 hours postoperative||||participants|||Number
1315171|NCT02432105|Secondary|Percentage of Subjects With Microbiological Success at Day 14|Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the Test-of-Cure (TOC) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 14|This analysis population includes all ITT subjects who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set).|||percentage of participants|||Number
1315172|NCT02432105|Primary|Percentage of Subjects With Sustained Clinical Cure at Day 8|A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 8|ITT analysis set|||percentage of participants|||Number
1315173|NCT02432040|Secondary|Adverse Events||6 months||||participants|||Number
1315174|NCT02432040|Secondary|Mean Change in hsCRP Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included since they were the only ones who had another hsCRP reading after baseline.|||nmol/L||Standard Deviation|Mean
1315175|NCT02432040|Secondary|Mean Change in Lipid Profile Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included.|||mg/dL||Standard Deviation|Mean
1315176|NCT02432040|Secondary|Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months||6 months|The number of patients analyzed were the ones who completed the study. Intention-to-treat analysis was done.|||units on a scale||Standard Deviation|Mean
1315177|NCT02432040|Secondary|Percentage of Patients Achieving PASI-50 at the End of 3 Months|PASI-50 means at least a 50% reduction from baseline PASI score|3 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||percentage of participants|||Number
1315178|NCT02432040|Secondary|Monthly Mean Changes in PASI Scores|PASI scores were measured monthly and mean changes from baseline for each month for the whole 6-month duration of the study recorded.|Monthly from baseline to 6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||units on a scale||Standard Deviation|Mean
1315179|NCT02432040|Primary|Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months|Percentage of patients in each arm who will achieve 50% reduction in PASI scores at the end of 6 months will be compared|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||percentage of participants|||Number
1315180|NCT02432040|Primary|Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months|Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 – none, 1 – slight, 2 – moderate, 3 – severe, and 4 – very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 – 0% involvement, 1 - <10%, 2 – 10-<30%, 3 – 30-<50%, 4 – 50-<70%, 5 – 70-<90%, 6 – 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||units on a scale||Standard Deviation|Mean
1315181|NCT02431754|Secondary|Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement|PGI-I (Drug Attributes Questionnaire [DRAQ]) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms.The DRAQ includes the following urinary symptoms: 1. Difficulty to void; 2. Frequent nighttime voiding; 3. Feeling of incomplete emptying; 4. Frequent daytime voiding; 5. Urinary urgency; 6. Taking a long time to urinate; 7. Need abdominal pressure to void; 8. Dribbling, leakage, and/or accidents. Each urinary symptom in the DRAQ will be evaluated by a participant using the PGI-I (discrete variables with seven categories) at the end of each treatment period, compared with how the symptom was before the participant's began taking medication in this study. The percentage of participants who reported a PGI-I (Drug Attributes Questionnaire) score of 1 to 3 are presented in the table below.|Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I (DRAQ) measurement.|||percentage of participants|||Number
1315182|NCT02431754|Secondary|Percentage of Participants With Global Impression of Improvement (PGI-I)|The PGI I is a participant rated instrument that measures the improvement or worsening of the subject’s symptoms based on a 7 point scale. A score of “1” indicates that the subject feels his symptoms are “very much better.” A score of “4” indicates that the subjects feels “no change” in his symptoms and a score of “7” indicates that the subject feels his symptoms are “very much worse.” The percentage of participants who reported a PGI-I score of 1 to 3 are presented in the table below.|Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I measurement.|||percentage of participants|||Number
1315183|NCT02431754|Secondary|Change From Baseline on the IPSS Quality of Life Score (IPSS QoL )|"IPSS QoL assess participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted (0), Pleased (1); Mostly satisfied (2); mixed about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total ranging from 0 to 6 with higher numerical score representing worse Quality of Life from BPH symptom."|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
1315184|NCT02431754|Secondary|Change From Baseline on the IPSS Voiding (Obstructive) Subscore|IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
1315185|NCT02431754|Secondary|Change From Baseline on the IPSS Storage (Irritative) Subscore|IPSS Storage (Irritative) subscore was the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline,Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
1315186|NCT02431754|Secondary|Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
1315187|NCT02431754|Primary|Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)|TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.|Week 20|All randomized participants who received at least one dose of study drug and completed the TPQ.|||percentage of participants|||Number
1315188|NCT02431741|Primary|Infection in the Wound (Signs of Clinical Infection)|Weekly Visual inspection of the wounds by the investigators.|weekly, for 5 weeks|ITT population|||participants|||Number
1315189|NCT02431598|Secondary|Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale|"no motion artifact~minimal motion artifact~moderate motion artifact~severe motion artifact~extensive motion artifact"|following contrast administration, up to 5 minutes||||scores on a scale||Full Range|Mean
1315190|NCT02431598|Secondary|Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging|Arterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test.|following contrast administration, up to 5 minutes||||percentage of participants with TSM|||Number
1315191|NCT02431598|Secondary|Heart Rate Following Contrast Injection|Heart rate following contrast injection|following contrast administration, up to 5 minutes||||beats per minute||Standard Deviation|Mean
1315192|NCT02431598|Secondary|O2 Saturation Following Contrast Administration||following contrast administration, up to 5 minutes||||percentage||Standard Deviation|Mean
1315193|NCT02431598|Primary|Subject-reported Dyspnea, as Measured by Questionnaire Responses|After each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold.|following contrast administration, up to 5 minutes||||units on a scale (1-5)||Standard Deviation|Mean
1315194|NCT02431598|Primary|Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath||following contrast administration, up to 5 minutes|All participants received all three drugs.|||seconds||Full Range|Median
1315195|NCT02431468|Post-Hoc|Severe Impairment Battery (SIB) Scores by Memantine Use at Baseline|Change from baseline in SIB score was compared between subjects receiving concurrent treatment with memantine and subjects not being treated with memantine.|Assessments at weeks 5, 9, 13, and 30 days after end of treatment (up to day 107).|Participants in the 3 treatment groups were further sorted by use of memantine. The number of participants in each category at each timepoint is noted. Attrition occurred through the course of the study.|||mean change from baseline in SIB score||Standard Deviation|Mean
1315196|NCT02431468|Secondary|Secondary Efficacy Endpoints|"Change from baseline in the Severe Impairment Battery (SIB) at Weeks 5 and 9. Assesses cognition. Score range 0-100. Lower scores indicate greater cognitive impairment.~Change from baseline in Alzheimer Disease Cooperative Study Activities of Daily Living Inventory-Severe Impairment Version (ADCS-ADL-SEV) at Weeks 5, 9,13. A 19-item test of the performance of activities of daily living. Total score range 0-54; lower scores indicate greater functional impairment.~Change from baseline in MMSE-2 at Weeks 5, 9 and 13. Tests selected aspects of cognition on a scale of 0-30. Lower scores indicate greater cognitive impairment.~Change from baseline in Neuropsychiatric Inventory (NPI) at Weeks 5, 9,13. Caregiver interview assesses 12 behavioral disturbances. Scores range from 0-144; higher scores indicate greater behavioral disturbances.~Clinical Global Impression of Improvement (CGI-I) at Weeks 5, 9, 13. A 7-point scale range from (1) very much improved to (7) very much worse."|Week 5, Week 9, Week 13|The number of participants analyzed over the course of the study diminished as a result of attrition.|||mean change from baseline||Standard Deviation|Mean
1315197|NCT02431468|Primary|Efficacy: Change From Baseline in Severe Impairment Battery (SIB) in the Full Analysis Set (FAS)|The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the total SIB score after 12 weeks of treatment, assessed at Week 13 (day 91). Efficacy analyses were conducted according to randomized groups. The SIB is used to assess cognition in subjects with moderate and severe AD. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.|Primary analysis at Week 13 (day 91) after 12 weeks of treatment (up to day 107)|The Full Analysis Set (FAS), consistent with a modified intention-to-treat principle (mITT), was defined as all randomized subjects who received at least one dose of randomized trial medication and who had at least one post-baseline assessment.|||mean change from baseline in SIB score||Standard Deviation|Mean
1315198|NCT02431468|Primary|Safety: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events|Evaluations of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia|Baseline through 30 days post end of treatment (up to Day 107)|Safety Analysis Set|||participants|||Number
1315199|NCT02431455|Secondary|Postoperative Respiratory Complication|atelectasis found on chest imaging, pneumonia, or re intubation|entire inpatient say, usually 1 to 7 days||||participants|||Number
1315203|NCT02431299|Secondary|Brief COPE Maladaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315204|NCT02431299|Secondary|UNCOPE Measure|"This meThis measure is a consumer rated substance abuse screener consisting of 6 yes or no questions. A response of yes is assigned a value of 1. The total number of yes responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues)."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315205|NCT02431299|Secondary|Medication Adherence Rating Scale|"This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as yes or no. A yes is assigned a value of 1. The scale ranges from 0 (no yes responses) to 10 (all yes responses endorsed). The total number of yes responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315206|NCT02431299|Secondary|Brief COPE Adaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315207|NCT02431299|Secondary|Adult State Hope Scale|"This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being Definitely False and 4 being Definitely True). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315208|NCT02431299|Secondary|Multidimensional Scale of Perceived Social Support|This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315209|NCT02431299|Secondary|Working Alliance Inventory Short Form|This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315210|NCT02431299|Primary|Illness Management and Recovery Treatment Integrity Scale|Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR.|3-Months||||units on a scale||Standard Deviation|Mean
1315229|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 34|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315211|NCT02431299|Primary|Illness Management and Recovery Scale|Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
1315212|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1315213|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1315214|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1315215|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1315216|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1315217|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1315218|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||hr||Full Range|Median
1315219|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||hours (hr)||Full Range|Median
1315220|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||mg/mL||Standard Deviation|Mean
1315221|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The Pharmacokinetic (PK) Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng/mL||Standard Deviation|Mean
1315222|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315223|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315224|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315225|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315226|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2||Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315227|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1||Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315228|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 26|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1315232|NCT02430532|Secondary|Change From Baseline to Week 108 in ABILHAND Questionnaire Score|The ABILHAND Questionnaire measures the participant’s perceived difficulty in performing everyday manual activities in the last 3 months. Participants fill in the 56-item questionnaire by estimating their own difficulty or ease in performing each of the 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability.|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315233|NCT02430532|Secondary|Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)|MSWS-12 is a participant self-assessment of walking limitations due to multiple sclerosis (MS) during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater negative impact on walking.|Baseline, 2 years|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315234|NCT02430532|Primary|Time to Disability Progression Independent of Relapse|Time to onset of confirmed progression of disability is defined as 1 or more of the following criteria, confirmed at ≥ 6 months after start of treatment and at Week 108 using 1 or more of the following assessments: Expanded Disability Status Scale (EDSS) score increased from Baseline of ≥ 1 point if baseline EDSS ≤ 5.5, or ≥ 0.5 point if Baseline EDSS ≥ 6.0; Timed 25-Foot Walk (T25FW) ≥ 20% increase from Baseline in the time taken for the 25-foot walk; worsening on the 9-Hole Peg Test (9HPT; ≥ 20% increase from Baseline in the time taken for the 9HPT, confirmed in the same hand). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.|Up to 108 weeks|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315235|NCT02430389|Secondary|Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations||10 minute window after head fixation||||participants|||Number
1315236|NCT02430389|Primary|Mean Arterial Blood Pressure After Head Fixation||Ten minute window after head fixation||||mm Hg||Standard Deviation|Mean
1315237|NCT02430090|Secondary|Number of Participants With Pain Scores on the Visual Analog Scale|Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement were recorded.|Up to 4 months|||||||
1315238|NCT02430090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.|Up to 4 months||||participants|||Number
1315239|NCT02429791|Secondary|Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48 or Withdrawal From the Study|The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0-6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Between and within treatment group comparisons were assessed on change from Baseline treatment satisfaction using the HIV TSQ at Weeks 4, 24 and 48 or withdrawal from the study. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population|||Scores on a scale||Full Range|Median
1315240|NCT02429791|Secondary|Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48 or Withdrawal From the Study|The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Between and within treatment group comparisons were assessed on change from Baseline in pre-specified treatment symptoms using the Symptom Distress Module at Weeks 4, 24 and 48 or withdrawal from the study. Change from Baseline in Symptom count and symptom bother score have been summarized. The symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). The symptom bother score ranges from 0 to 80. Last observation carried forward (LOCF) was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population|||Scores on a scale||Standard Deviation|Mean
1315241|NCT02429791|Secondary|Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1), 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||mmol/ mL||Standard Deviation|Mean
1315242|NCT02429791|Secondary|Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Day 1|CVW Population||||||
1315243|NCT02429791|Secondary|Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Day 1|CVW Population||||||
1315244|NCT02429791|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening|Up to 48 weeks|Safety Population|||Participants|||Number
1315245|NCT02429791|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INI, NNRTI, PI) was summarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to 48 weeks|Safety Population|||Participants|||Number
1315246|NCT02429791|Secondary|Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INI, NNRTI, or PI) was summarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to 48 weeks|Safety Population|||Participants|||Number
1315247|NCT02429791|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class|Blood for CD4 cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 48|ITT-E Population|||Cells per mm^3||Standard Deviation|Mean
1315248|NCT02429791|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using cochran-mantel haenszel test stratified by current antiretroviral third-agent class. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population|||Percentage of participants|||Number
1315249|NCT02429791|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV|Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG + RPV. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose at Week 2, 4 and 8|PK Parameter NNRTI Subset extra sampling Population|||ug/ L||Standard Deviation|Mean
1315250|NCT02429791|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 4, 24 and 48 or Withdrawal in Participants Switching to DTG + RPV|Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24 and 48. Pre-dose concentrations of DTG and RPV at Weeks 4, 24 and 48 or withdrawal were summarized for the participants switching to DTG + RPV in the early switch phase. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Parameter Population consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0).|Pre-dose at Week 4, 24 and 48 or at withdrawal visit|PK Parameter Population|||ug/ L||Standard Deviation|Mean
1315251|NCT02429791|Secondary|Phenotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria|Phenotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicate that data were not applicable based on drugs were not received. Phenotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.|Day 1|CVW Population|||Participants|||Number
1315252|NCT02429791|Secondary|Genotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria|Genotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicate that data were not applicable based on drugs not received. Genotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.|Day 1|CVW Population|||Participants|||Number
1315253|NCT02429791|Secondary|Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48|Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||mmol/ L||Standard Deviation|Mean
1315254|NCT02429791|Secondary|Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR) index, the product of basal glucose and insulin levels divided by 22.5 (1,2), is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.|Up to Week 48|Safety Population|||HOMA-IR Score||Standard Deviation|Mean
1315255|NCT02429791|Secondary|Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||Nanograms (ng)/ L||Standard Deviation|Mean
1315256|NCT02429791|Secondary|Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type I Collagen C-Telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Up to Week 48|Safety Population|||ug/ L||Standard Deviation|Mean
1315257|NCT02429791|Secondary|Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48|Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||Grams (g)/ mol||Standard Deviation|Mean
1315258|NCT02429791|Secondary|Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine B2M and urine RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). For 25 hydroxy-vitamin D, analysis of changes from baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Up to Week 48|Safety Population|||Nanomoles (nmol)/ L||Standard Deviation|Mean
1315259|NCT02429791|Secondary|Mean Change From Baseline in Urine Phosphate at Week 48|Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||Millimoles (mmol)/ L||Standard Deviation|Mean
1315260|NCT02429791|Secondary|Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||mg/ deciliter (dL)||Standard Deviation|Mean
1315261|NCT02429791|Secondary|Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||Microgram (ug)/Liter||Standard Deviation|Mean
1315262|NCT02429791|Secondary|Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||Nanogram/milliliter||Standard Deviation|Mean
1315263|NCT02429791|Secondary|Mean Change From Baseline in D-Dimer at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||Nanomole (nmol)/L FEU||Standard Deviation|Mean
1315264|NCT02429791|Secondary|Mean Change From Baseline in Cystatin C at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||mg/L||Standard Deviation|Mean
1315266|NCT02429791|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening|Up to 48 weeks|Safety Population|||Participants|||Number
1315267|NCT02429791|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to 48 weeks|Safety Population|||Participants|||Number
1315268|NCT02429791|Secondary|Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4, AE Leading to Discontinuation (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with common non-serious AE, SAE, AELD or AE with maximum grade toxicity experienced over Week 48 was summarized. Common AEs were those with >5 percent incidence for either treatment. Safety Population included all randomly assigned participants who have received at least one dose of study drug.|Up to 52 weeks|Safety Population|||Participants|||Number
1315269|NCT02429791|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG + RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12 and 24.|Week 24|ITT-E Population|||Percentage of participants|||Number
1315270|NCT02429791|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48|Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and 48|ITT-E Population|||Cells per millimeter (mm)^3||Standard Deviation|Mean
1315271|NCT02429791|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. Treatment with DTG + RPV was declared non-inferior to CAR if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 lies above -10% by Cochran-Mantel Haenszel test. The Intent-to-Treat Exposed (ITT-E) population consisted of all randomly assigned participants who received at least one dose of study drug.|Week 48|ITT-E Population|||Percentage of participants|||Number
1315272|NCT02429258|Secondary|Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 – ITT Population||Baseline to Week 4||||10^-9 min^-1||Standard Error|Least Squares Mean
1315273|NCT02429258|Secondary|Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
1315274|NCT02429258|Secondary|Change in Fructosamine From Baseline to Week 4||Baseline to Week 4||||mmol/L||Standard Error|Least Squares Mean
1315275|NCT02429258|Secondary|Change in HbA1c From Baseline to Week 4||Baseline to Week 4||||% Alc||Standard Error|Least Squares Mean
1315276|NCT02429258|Secondary|Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
1315277|NCT02429258|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
1315278|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 – ITT Population||Baseline to Week 4||||Change in percentage||Standard Error|Least Squares Mean
1315279|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 – ITT Population||Baseline to Week 4||||Change in percentage||Standard Error|Least Squares Mean
1315280|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 – ITT Population||Baseline to Week 4||||Change in percentage||Standard Error|Least Squares Mean
1315283|NCT02428699|Secondary|Tmax of Sum of Total and Free EPA|Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||h||Standard Deviation|Mean
1315284|NCT02428699|Secondary|Tmax of Sum of Total and Free DHA|Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||h||Standard Deviation|Mean
1315285|NCT02428699|Secondary|Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA|Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||h||Standard Deviation|Mean
1315286|NCT02428699|Secondary|Cmax of Sum of Total and Free EPA|Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315287|NCT02428699|Secondary|Cmax of Sum of Total and Free DHA|Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315288|NCT02428699|Secondary|Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA|Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315289|NCT02428699|Secondary|iAUC0-10h of Sum of Total and Free DHA and EPA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Upto 10 h|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315290|NCT02428699|Secondary|iAUC0-10h of Sum of Total and Free EPA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Upto 10 h|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315291|NCT02428699|Secondary|iAUC0-10h of Sum of Total and Free DHA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Upto 10 h|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315292|NCT02428699|Secondary|iAUC0-24h of Sum of Total and Free EPA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315293|NCT02428699|Secondary|iAUC0-24h of Sum of Total and Free DHA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
1315519|NCT02420041|Primary|Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy|during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin|difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes||||minutes||Full Range|Mean
1315294|NCT02428699|Primary|Incremental Area Under the Curve to 24 Hours (h) (iAUC0-24h) of the Sum of Plasma Total and Free n-3 Fatty Acids (Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Baseline and up to Day 2|Per protocol (PP) population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||Microgram per mililiter (µg/mL)||Standard Deviation|Mean
1315295|NCT02428478|Secondary|Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility|Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are passive; Active Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are active. Improved=more negative Pcrit.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.|||cm H2O||Inter-Quartile Range|Median
1315296|NCT02428478|Primary|Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity|Electromyography (EMG) was used to analyze genioglossus (GG) [EMG GG] muscle movement. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus (tongue) muscle. Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Sleep values were then expressed as %wakefulness value for tonic and phasic EMG GG activity. Tonic activity was defined as the lowest EMG GG value during expiration, phasic activity was calculated as the peak value during inspiration minus the tonic value.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.|||percent wakefulness||Inter-Quartile Range|Median
1315297|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration|For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]|1 hour post-operative recovery period||||minutes||Inter-Quartile Range|Median
1315298|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time|For MAX-WAG measurements obtained every 30 seconds, we calculated the percentage of time in MAX-WAG [>2ppm] relative to the total collection period.|1 hour post-operative recovery period||||percentage of time||Inter-Quartile Range|Median
1315299|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions|The measurement of Waste Anesthetic Gas in parts per million emanating from the patient between the standard oxygen mask and the ISO-Gard oxygen mask.|1 hour post-operative recovery period||||parts per million||Standard Deviation|Mean
1315300|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients|The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.|1 hour post-operative recovery period|A study size of 100 randomized subjects will be used. Aforementioned sample size was determined to be able to detect an effect size of 0.57 that would provide 80% power and 5% type I error (95% confidence interval and p-0.05 level of significance). Two sample student t-test will be used to do data analysis.|||parts per million||Standard Deviation|Mean
1315301|NCT02428231|Secondary|Average Change From Baseline in GSRS Scores to the End of Weeks 4, 6, 8, 10, 12, and 14|Average change from baseline to end of DMF treatment in the GSRS. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms.|Week 2 (Baseline), Weeks 4, 6, 8, 10, 12, 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315302|NCT02428231|Secondary|Time to Recovery to Baseline From Last Occurrence of Worst GSRS Score|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315323|NCT02427399|Secondary|Proportion Receiving Pap Test at 12 Months|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|12 months||||Participants|||Count of Participants
1317278|NCT02368314|Primary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.|||participants|||Number
1315303|NCT02428231|Secondary|Time to First Worsening From Baseline in GSRS Score|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315304|NCT02428231|Secondary|Average Change From Baseline in GSRS Scores During DMF Treatment|Average change from baseline in GSRS scores over the 12 weeks of DMF treatment as measured by the total change in GSRS scores from baseline divided by the total number of days with GSRS scores recorded. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315305|NCT02428231|Primary|Proportion of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the Gastrointestinal Symptom Rating Scale (GSRS)|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|from Week 2 (Baseline) to Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1315306|NCT02427984|Secondary|Number of Participants Who Scored Positive for ALVAL|"Histological score defined by the valuation of staining It was possible to valuate this outcome only for 29 out of 40 patients MoM (due to the availability of periprosthetic tissues).~The arms CoC and controls were not studied for this issue because ALVAL could occur only in presence of Metals"|3 years|positive for ALVAL is +, negative for ALVAL is -|||participants|||Number
1315307|NCT02427984|Primary|Amplitude of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in amplitude (decibel) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years||||decibel||Full Range|Mean
1315308|NCT02427984|Primary|Frequency of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in frequency (Hz) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years||||Hz||Full Range|Mean
1315309|NCT02427984|Primary|Duration of Articular Noise Produced During Level Walking|"Measured by fast Fourier transform (FFT) expressed in duration (milliseconds)~This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)"|3 years||||milliseconds||Full Range|Mean
1315310|NCT02427984|Primary|Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l|"Measured by Inductively coupled plasma mass spectrometry (ICP-MS), equipped with dynamic cell reaction (ELAN DRC II) and expressed in micrograms/liter.~Will be counted the number of patients with level os metals above 7micrograms/liter~This outcome is valuable only for MoM arm and Control arm (as comparison), because CoC arm patients don't wear device releasing this kind of metals."|3 years|the population was evaluated as number of patients with ions level above 7ug/l (attention limit)|||participants above limit|||Number
1315311|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one vaccination of TIV is reported.|Day 1 to Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data|||Number of Subjects|||Number
1315312|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.|Day 1 to Day 4 post vaccination|Analysis was done on the unsolicited safety set population i.e., all subjects who have post vaccination unsolicited adverse event data.|||Number of Subjects|||Number
1315313|NCT02427750|Primary|Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination (including 30 mins)|Analysis was done on the solicited safety set population i.e. all subjects who have post vaccination solicited local and systemic adverse event data.|||Number of Subjects|||Number
1315314|NCT02427750|Primary|GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.|"The antibody responses following one vaccination of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/Day 1 post vaccination|The analysis was performed on the PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1315315|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 post vaccination|The analysis was performed on the PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
1315316|NCT02427750|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
1315317|NCT02427750|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22/ Day1 post vaccination|The analysis was performed on the PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1315318|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm^2 achieving a post vaccination SRH area ≥ 25mm^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area > 4mm^2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination SRH areas."|Day 22 post vaccination|The analysis was performed on the PP dataset|||Percentages of subjects||95% Confidence Interval|Number
1315319|NCT02427750|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm^2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the per-protocol population (PP).|||Percentages of subjects||95% Confidence Interval|Number
1315320|NCT02427607|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment. Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment. SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening.|From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months|Safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341.|||Participants|||Number
1315321|NCT02427477|Primary|Subjective Overall Vision|Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).|||units on a scale|Observations|Standard Deviation|Mean
1315322|NCT02427477|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).|||units on a scale|Observations|Standard Deviation|Mean
1315324|NCT02427399|Secondary|Proportion Receiving Pap Test at 6 Months|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|6 months||||Participants|||Count of Participants
1315325|NCT02427399|Primary|Proportion of Patients Who Receive a Pap Test at End of Follow up|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|18 months||||Participants|||Count of Participants
1315326|NCT02426541|Primary|Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake|Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)|From baseline to Week 8|Full analysis set|||umol/min/kg||Standard Error|Least Squares Mean
1315327|NCT02426541|Secondary|Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8|Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET|Baseline to Week 8|Full analysis set|||umol/min/kg||Standard Error|Least Squares Mean
1315328|NCT02426541|Secondary|Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake|Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET|Baseline to Week 8|Full analysis set|||umol/min/kg||Standard Error|Least Squares Mean
1315329|NCT02425956|Secondary|Serum Ferritin Based on Blood Draw|The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).|48 hours post MR scan or 24 hours pre MR scan|Every enrolled subject|||mg FE /g dry||Standard Deviation|Mean
1315330|NCT02425956|Primary|Per Subject Evaluable DICOM Data Sets From Liver MRI|The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.|48 hours pre or 24 hours post blood draw|MR DICOM datasets were gathered for each enrolled subject (total of three scans per subject equals one complete dataset)|||Participants|||Count of Participants
1315331|NCT02425826|Secondary|Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase|Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Date of first dose of apremilast during the placebo controlled phase or date of first dose of apremilast after week 16; overall maximum duration of exposure was 61.5 weeks during apremilast-exposure phase|The safety population includes all participants who were randomized and received at least one dose of study drug; apremilast participants as treated.|||participants|||Number
1315332|NCT02425826|Secondary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase|Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|From first dose of study drug to Week 16; maximum duration of exposure was 20.1 weeks during placebo controlled phase|The safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
1315333|NCT02425826|Secondary|Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician’s Global Assessment (ScPGA) Response From Week 16 to Week 52.|The ScPGA will assess scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment with scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA is restricted to the participants with scalp involvement at baseline.|Week 16 to Week 52|Participants who were initially randomized to apremilast and continued through week 52.|||percentage of participants||95% Confidence Interval|Number
1315334|NCT02425826|Secondary|Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score."|Baseline to Week 52|Apremilast participants who entered and were treated in the apremilast extension phase.|||percentage change||Standard Deviation|Mean
1315335|NCT02425826|Secondary|Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
1315336|NCT02425826|Secondary|Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
1315337|NCT02425826|Secondary|Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage change||Standard Deviation|Mean
1315338|NCT02425826|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52|The TSQM version II is an 11-question self-administered instrument to understand a participants satisfaction on the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment.|Baseline to week 52|Apremilast participants who entered and were treated in the apremilast extension phase.|||units on a scale||Standard Deviation|Mean
1315339|NCT02425826|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16|The TSQM version II is an 11-question self-administered instrument to understand a participation’s satisfaction with the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score mean indicates higher satisfaction with treatment.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed LOCF.|||units on a scale||Standard Deviation|Mean
1315340|NCT02425826|Secondary|Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician’s Global Assessment (ScPGA) Scale at Week 16.|The ScPGA assessed scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment. Scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA was restricted to the participants with scalp involvement at baseline.|Baseline to Week 16 (end of phase)|The ITT population with scalp psoriasis who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
1315341|NCT02425826|Secondary|Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)|The Pruritus VAS assessment was conducted at the baseline visit and each post-baseline visit. The participant was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (0) represents no itch, and the right-hand boundary (100) represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded. The Pruritus VAS score ranges from 0 to 100. Higher scores correspond to more severe symptom.|Baseline to Weeks 1 and 16 (end of phase)|ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1315342|NCT02425826|Secondary|Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline|The PtGA response rate is defined as the percentage of participants achieving 0 (clear) or 1 (very mild) on the PtGA scale at Week 16. The PtGA is the assessment by the participant of the overall disease severity at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe).|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
1315343|NCT02425826|Secondary|Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with and at least one post-baseline value are included. A missing value at Week 16 was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
1315353|NCT02424591|Secondary|Beck's Depression Inventory|"Beck's Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures attitudes and symptoms of depression. Each sentence has a rating from 0 to 3 and the sentences go from mild to fairly severe descriptions of moods. The numbers are tabulated, the lowest possible score is 0 and the highest is 63.~A score of 1-10 indicates normal ups and downs. 11-16 indicates a mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; over 40, extreme depression"|Post-op Day 3||||points||Inter-Quartile Range|Median
1329600|NCT02107014|Primary|Change in G-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1315344|NCT02425826|Secondary|Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1315345|NCT02425826|Primary|Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes."|Baseline to Week 16 (end of phase)|The Intent-to-Treat (ITT) population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value were included. A missing value at Week 16 was imputed by last observation carried forward. (LOCF).|||percentage change||Standard Deviation|Mean
1315346|NCT02425449|Primary|Fade on Train of Four Stimulation|We stimulated the ulnar nerve at the wrist four times (over 1.5 seconds) every 20 seconds. We measured the ratio of the fourth contraction to the first contraction before and after the administration of succinylcholine. Before administering succinylcholine the ratio is normally one. After the administration of succinylcholine the first contraction diminishes, but the fourth contraction diminishes even more. This results in a ratio of T4 to T1 being less than one. The lowest ratio recorded after the administration after the administration of succinylcholine is reported as our outcome measure.|for the duration of the effect of succinylcholine generally expected to be 6-10 minutes||||Ratio||Standard Deviation|Mean
1315347|NCT02424734|Secondary|Percentage of Participants With Favorable Microbiological Response|Microbiological response was determining programmatically and assessed at the participants level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (participant's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the participant was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug.|EOT visit (up to Day 15), TOC visit (up to Day 29)|Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy).|||percentage of participants||95% Confidence Interval|Number
1315348|NCT02424734|Secondary|Percentage of Participants With Favorable Clinical Response|Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure (defined as resolution of all acute signs and symptoms of Late-onset sepsis [LOS] or improvement to such an extent that no further antibacterial therapy is required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after the last dose of study therapy.|EOT visit (up to Day 15), TOC visit (up to Day 29)|Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy]).|||percentage of participants||95% Confidence Interval|Number
1315349|NCT02424734|Secondary|Plasma Concentration of Ceftaroline M-1||At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI|||||||
1315350|NCT02424734|Secondary|Plasma Concentration of Ceftaroline||At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI|||||||
1315351|NCT02424734|Secondary|Plasma Concentration of Ceftaroline Fosamil||At the end of infusion (EOI)|||||||
1315352|NCT02424734|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to SFU visit (up to a maximum study duration of 49 days)|Safety analysis set consisted of all enrolled participants for whom informed consent form was signed and received any amount of ceftaroline fosamil.|||participants|||Number
1315354|NCT02424591|Secondary|Pain Score|"McGill Short Form measures pain in different ways. The first part of the form lists 15 adjectives for pain, for which the answers can be none (0), Mild (1), Moderate (2) and Severe (3). Descriptors 1-11 represent the sensory dimension of pain experience and 12-15 represent the affective dimension. A score of 0 is good, and a score of 45 indicates extreme pain. The lower the score the less pain a subject feels (better), as the scores go up, so do the pain levels (worse).~PPI (Present Pain Intensity) asks patients to measure pain from 0 (no pain) to 5 (excruciating). Again, a lower score is ideal."|Post-op Day 3||||points||Inter-Quartile Range|Median
1315355|NCT02424591|Primary|Scores on Questionnaires|Quality of Recovery 15 questions questionnaires that ask, on a scale of 0-10, with 0 always being bad and 10 always being best, how the patient is recovering. The total number is reviewed, so the highest total score possible is 150 and the lowest is 0.|Post-op Day 3||||points||Inter-Quartile Range|Median
1315356|NCT02424578|Secondary|Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination||Baseline to Day 3/Early Termination|||||||
1315357|NCT02424578|Primary|Plasma Concentration of Diclofenac|The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.|0-6 hours after first dose of diclofenac|Pharmacokinetic (PK) population. Defined as all subjects who received at least one dose of study drug and had at least one quantifiable plasma diclofenac concentration after dosing.|||mL/hr||Standard Error|Mean
1315358|NCT02424565|Primary|Time to Significant Increase in Local Surface Temperature|Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant.|Every minute from baseline to 10 minutes|Intent-to-treat (ITT) population included all participants of safety population with any post-treatment assessment. Since no significant increase in surface temperature was observed in subjects for either treatment, therefore, number of subjects analyzed for this outcome is zero.||||||
1315359|NCT02424357|Secondary|Identification of Bacterial Species Cultured From Suture Material|The collected sutures will be monitored for bacterial growth for up to 7 days. When bacterial growth is observed, 1 mL of the solution will be inoculated on chocolate, MacConkey, and anaerobic blood agars and incubated for an additional 24 to 48 hours to identify organisms and quantify growth. In vitro susceptibility patterns will be determined.|7 days plus 24 to 48 hours|All 65 participants were analyzed: 53 sutures had positive cultures (34 of the adjustable sutures and 19 of the control sutures). The relative risk between the two treatment arms indicated no difference in colonization rate, the bacterial species were not analyzed separately. Three of the sutures yielded 2 bacterial species.|||number of positive bacterial isolates|sutures||Number
1315360|NCT02424357|Secondary|Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine|Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion|48 hours||||relative risk|sutures|95% Confidence Interval|Number
1315361|NCT02424357|Primary|Suture Colonization Rate in Adjustable Suture Strabismus Surgery|1 cm section of the suture proximal to the knot will be harvested and placed in a tube with 2 ml of trypticase soy broth (TSB).The TSB tubes will be monitored for growth of bacteria at 48 hours|48 hours||||percentage sutures positive for bacteria|sutures||Number
1315362|NCT02424149|Secondary|Trial of Void Results|Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.|Day of hospital discharge|For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void.|||participants who failed trial of void|||Number
1315363|NCT02424149|Secondary|Post-operative Urethral Discomfort Measured by Pain Scales|Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.|post operative day 1||||units on a scale||Standard Deviation|Mean
1315364|NCT02424149|Secondary|Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR|this is a composite measure and will be reported as a single value for each arm as number of additional interventions|day of surgery (day 0)||||interventions|||Number
1315365|NCT02424149|Secondary|Physician Confidence Measured by a Survey|"Surgeon response to the question: I am confident that ureteral injury was ruled out in this patient on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree"|day of surgery (day 0)||||units on a scale||Standard Deviation|Mean
1315366|NCT02424149|Primary|Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room|Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.|Day of surgery||||seconds||Standard Deviation|Mean
1315367|NCT02423993|Secondary|Quality of Life (SF36 Questionnaire)|"We assessed QoL changes during the study and differences of these changes between groups.~SF-36 questionnaire enabling evaluation of patient’s satisfaction with his health status and certain emotional characteristics. 36 items of the Questionnaire are grouped in 8 scales. Each scale ranges from 0 to 100, the latter representing full health."|4 months after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.|||units on a scale||Inter-Quartile Range|Median
1315368|NCT02423993|Secondary|Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)|Treatment compliance evaluation was based on frequency of SMBG and bolus calculator use as one of the factors mediating achievement of target plasma glucose level.|within 4 month of the study||||events||Standard Deviation|Mean
1315370|NCT02423993|Secondary|Nonsevere Hypoglycaemia Frequency|Nonsevere hypoglycemia is defined аs an episode of a blood glucose value of less than 70 mg per deciliter (3.9 mmol per liter). All hypoglycaemia episodes was reported in patients dairies and then will be assessed and compared between groups.|within 4 month of the study||||events per day||Standard Deviation|Mean
1315371|NCT02423993|Secondary|Quality of Life (ADDQoL Questionnaire)|"Will be assessed QoL changes during the study and differences of these changes between groups.~ADDQoL Questionnaire includes 2 general scales and 18 specific scales. 2 general scales represent the general QoL and diabetes – dependent QoL (scales varies from -3 (worse) to +3 (better)). 18 specific scales represent the impact of diabetes on certain QoL parameters: working life, family life, social life, sex life, physical appearance, do physically, leisure, travel, confidence in ability, motivation, society reaction, future, finances, dependence, living conditions, freedom to eat, other’s , freedom to drink. All scales varies from -9 (worse) to +9 (better)."|4 month after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.|||units on a scale||Standard Deviation|Mean
1315372|NCT02423993|Secondary|Severe Hypoglycaemia Frequency|Severe hypoglycemia is defined аs an episode requiring assistance and will be confirmed by documentation of a blood glucose value of less than 50 mg per deciliter (2.8 mmol per liter) or recovery with restoration of plasma glucose.|within 4 month of the study||||events per month||Standard Deviation|Mean
1315373|NCT02423993|Primary|HbA1c|HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.|4 month after CSII initiation|"The analysis was per protocol. Patients from group education groups were on MDI regymen and from standart education group were on insulin pump therapy during previously 4 months"|||percentage||Inter-Quartile Range|Median
1315374|NCT02423980|Secondary|Time to Resolution of Induced Hypoglycemia Symptoms|Prior to and every 5 minutes after treatment, subjects were asked to rate the severity of each of 8 symptoms on a scale from 1 to 6, with 1 indicating the symptom was absent and 6 indicating the symptom was severe. The sum of the scores for the 8 individual symptoms was reported as the total hypoglycemia symptom score, which ranged from 8-48. The first time point post-treatment at which total hypoglycemia symptom score = 8 (i.e., all symptoms were absent) was considered the time to resolution. One and two subjects were unevaluable for response to the 1 mg and 0.5 mg doses of glucagon, respectively, as they reported no symptoms (i.e., total symptom score = 8) prior to treatment.|0-30 minutes|Subjects with symptoms of hypoglycemia at time of treatment|||minutes||Full Range|Median
1315375|NCT02423980|Secondary|Time to Plasma Glucose > 70 mg/dL|Following treatment, plasma glucose was measured every 5 minutes. The first such measurement at which plasma glucose concentration was observed to be >70 mg/dL was reported as the time to response.|0-90 minutes|All treated subjects|||minutes||Full Range|Median
1315376|NCT02423980|Primary|Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment|For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to >70 mg/dL within 30 minutes of treatment being considered a positive response.|0-90 minutes|All treated subjects|||participants with positive response|||Number
1315377|NCT02423798|Primary|Sensor Survival|sensor survival in hours|4 months||||hours||95% Confidence Interval|Mean
1315378|NCT02423798|Primary|Consensus Error Grid Analysis of Paired Sensor and Reference Plasma Glucose Values|"All analysis performed using the Consensus Error Grid (or Parkes error grid) comparing the paired sensor and YSI reference glucose values.~Zone A is defined in the Parkes error grid as the zone of “clinical accurate measurements with no effect on clinical action.” Zone B as “altered clinical action with little or no effect on clinical outcome.”. Ideal situation is 100% in Zone A + B."|4 months||||percentage|||Number
1315379|NCT02423798|Primary|Sensor Accuracy|Sensor values were compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing day (day 3). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).|4 months||||percentage||Standard Deviation|Mean
1315380|NCT02423577|Primary|Frequencies of Viral Shedding|Percentage of Subjects Demonstrating Viral Shedding.|Day 2 to Day 10|The percentage of subjects demonstrating viral shedding was estimated for each treatment with corresponding asymptotic 95% confidence intervals, based on the normal approximation to the binomial distribution (Wilsons’s method)|||Participants|||Count of Participants
1315381|NCT02423447|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
1315382|NCT02423447|Primary|Dry Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention||||gram||Full Range|Mean
1315383|NCT02423447|Secondary|PRO (Patient-reported Outcome)|Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.|End of study visit per intervention|Patients rated comfort on a scale of 1 (most comfortable) to 10 (most un-comfortable)|||units on a scale||Full Range|Mean
1315384|NCT02423447|Secondary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
1315385|NCT02423447|Primary|Wet Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention||||gram||Full Range|Mean
1315430|NCT02422797|Secondary|Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48|Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||Grams (g)/ mol||Standard Deviation|Mean
1315386|NCT02423408|Secondary|Number of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders)|"The Carvalho Responder analysis refers to subjects with at least 2 categories of improvement in their VAS severity category (0-100 scale). VAS severity categories were defined as severe if between 52-100 inclusive, moderate between 31-51 inclusive, mild between 6-30 inclusive, and pain-free if less than 6. Therefore, a Carvalho responder was either a subject who had a VAS response classified as ‘severe’ at baseline and ‘mild’ or pain-free at the post-dose assessment time point, or a subject who had a VAS response classified as ‘moderate’ at baseline and pain-free at the post-dose assessment time point."|2 hours|"Only subjects who were categorized as severe or moderate at baseline and have data reported at 2 hours were included in this analysis. All subjects who took rescue medication at or before 2 hours were considered non-responders."|||Participants|||Count of Participants
1315387|NCT02423408|Secondary|Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period||24-hour post-dose period|8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses.|||Participants|||Count of Participants
1315388|NCT02423408|Secondary|Number of Subjects Pain Free at 15, 30, 60, 90 Minutes and 4 Hours Post-dose (Pain Will be Assessed by 4-point NRS, VAS, and Binary Yes/no Question)|"4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe.~VAS: 0-100 scale, No Pain vs. Worst Imaginable Headache Pain"|15, 30, 60, 90 minutes and 4 hours post-dose|"LOCF Analysis~8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses."|||Participants|||Count of Participants
1315389|NCT02423408|Primary|Number of Subjects Pain Free|"Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question).~4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; pain-free defined as score = 0.~VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). Pain-free was defined as a score <= 5"|2 hours|"LOCF Analysis~8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses."|||Participants|||Count of Participants
1315390|NCT02423317|Secondary|Number of Participants With Airway Trauma|Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.|5 minutes||||participants|||Number
1315391|NCT02423317|Secondary|Number of Esophageal Intubation.|Insertion of tracheal tube inside the esophagus|5 minutes||||esophageal intubation|||Number
1315392|NCT02423317|Secondary|Overall Intubation Success Rate.|It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.|5 minutes||||participants|||Number
1315393|NCT02423317|Secondary|Percentage of Glottic Opening Scoring.|The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch|5 minutes||||percentage of glottic opening||Inter-Quartile Range|Median
1315394|NCT02423317|Secondary|Ease of Intubation.|The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.|5 minutes||||scores on visual analogue scale||Inter-Quartile Range|Median
1315395|NCT02423317|Secondary|Number of Intubation in First Attempts;|A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.|5 minutes||||Intubations|||Number
1315396|NCT02423317|Primary|Time to Intubation|It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform|5 minutes||||seconds||Standard Deviation|Mean
1315397|NCT02423291|Primary|Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL|"The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment."|42 months|Trial was closed due to drug inefficacy on 14/Jul/2016 (last enrollment on 30/Jun/2015). Details in the Outcome Measure Data Table.|||Participants|||Count of Participants
1315398|NCT02423200|Secondary|Episodic Memory Function|Total Recall in Hopkins Verbal Learning Test (HVLT). Range is 0-36, with increases in score indicating improvement in cognitive function.|Change from baseline to Day 42|As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in all outcome measure analyses. In addition, one subject did not have a Day 42 HVLT-R analysis.|||points on HLVT Total Recall (range 0-36)||Standard Deviation|Mean
1315399|NCT02423200|Secondary|Maximal CSF VX-745 Concentration|Ratio fo CSF to plasma drug concentration at time matched time points. Samples taken|All samples with quantifiable CSF drug levels were included (n=12). Eight were obtained 3-hours post-dose, either on Day 1 (n=4) or Day 42 (n=4). 3 samples were at 6-hours post-dose on Day 42; and one was at 6-hours post-dose on Day 1.|As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in this analysis.|||ratio of plasma drug concentration||Standard Deviation|Mean
1315400|NCT02423200|Secondary|Severe or Serious Adverse Events|Number of patients with severe or serious adverse events|At baseline and at each study visit during (days 1, 7, 14, 21, 28, 35 and 42) and after (day 51) dosing||||Participants|||Count of Participants
1317519|NCT02361736|Secondary|Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point|eGFR is calculated by concentration of creatinine and CKD-EPI2009|-1d, 0d, 1d, 3d, 5d after surgery||||mL/min/1.73m2||Standard Deviation|Mean
1315401|NCT02423200|Primary|Percent Change From Baseline to End of Treatment in Cerebrospinal Fluid Levels of Cytokines|Cytokines: Of nine cytokines assessed, only CSF IL-8 quantifiable at all time points. And so, only IL-8 levels are being reported herein. The analysis was exploratory and no statistical analysis was performed.|Baseline and Day 42 of dosing with VX-745|As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in this analysis. In addition, two subjects did not have Day 42 CSF samples available for analysis|||percentage of baseline at Day 42||Standard Deviation|Mean
1315402|NCT02423109|Primary|Comfort Preference|Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.|Dispensing (Baseline) and 2 weeks|Analysis population differs slightly due to protocol deviation.|||Participants|||Count of Participants
1315403|NCT02423109|Primary|Comfort (Subjective Rating Scale)|Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)|Dispensing (Baseline) and 2 weeks|Analysis population differs slightly due to 1 participant who was excluded from analysis due to a protocol deviation.|||units on a scale||Standard Deviation|Mean
1315404|NCT02422940|Secondary|Change From Baseline on the 12-item Health Survey (SF-12)|"The SF-12 v2 (4-week recall) is a general health-related quality-of-life profile measure consisting of 12 items. The SF-12 Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores will be derived and normed to a general United States population for score algorithm. The normalized PCS and MCS scores will be calculated at baseline, Month 12, and subsequent visits.~SF-12 is a Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||score on a scale||Standard Deviation|Mean
1315405|NCT02422940|Secondary|Subject Global Impression (SGI)|"The Subject Global Impression (SGI) is single item measure of treatment response that asks the subject to rate the effects of the investigational drug on his or her overall walking ability using a 7 point scale ranging from 1 = Terrible” to 7 = “Delighted.”"|Visit 8 (Month 12)|The study was conducted in patients with chronic walking deficits from an ischemic stroke. These were the only participants to finish the SGI study due to study termination.|||Participants|||Count of Participants
1315406|NCT02422940|Secondary|Change From Baseline on the Stroke Impact Scale (SIS)|The SIS consists of 59 items grouped in 8 domains: strength, hand function, activities of daily living (ADL) / instrumental activities of daily living (IADL), mobility, communication, emotion, memory and thinking, and participation/role function. The subject is asked to rate the level of difficulty in performing each item in the preceding week. Each item is scored on a 5-point scale ranging from 1 (inability to complete the item) to 5 (no difficulty experienced at all). For each domain, the SIS score will be calculated by summing all the items within the domain and transforming into a scale with a range of 0 to 100 as follows: SIS Score = 100 * [(Actual raw score – Lowest possible raw score)/ (Highest possible raw score-Lowest possible raw score)].|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||score on a scale||Standard Deviation|Mean
1315407|NCT02422940|Secondary|Change From Baseline on the Walking Impact Scale (Walk-12)|The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility. Walk-12 Score = 100 * [(Mean of the 12 items) – 1]/(5-1)|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||units on a scale||Standard Deviation|Mean
1315408|NCT02422940|Secondary|Change From Baseline on the Timed up and Go (TUG) Test|The TUG measures mobility and balance and can predict the risk of falls. This test, which was initially called the Get-up and Go test, is considered a measure of dynamic balance. The subject is asked to stand up from a chair, walk 10 feet at a comfortable pace, turn around and be seated. The Timed Up and Go (TUG) is measured in seconds. There will be one practice test and then the timed test. Only the timed test will be analyzed at each visit time point. Reciprocal transformation may be performed if the time values are markedly skewed.|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||Seconds||Standard Deviation|Mean
1315409|NCT02422940|Secondary|Change From Baseline on the 10 Meter Walk Test (10MWT)|10 Meter Walk Test (10MWT) and Change from Baseline by Visit|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||Meter /second||Standard Deviation|Mean
1315410|NCT02422940|Secondary|Change From Baseline on the Two-Minute Walk Test (2MinWT)|2 Minute Walk Test (2MinWT) and Change from Baseline by Visit|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||Feet||Standard Deviation|Mean
1315411|NCT02422940|Primary|The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.|This extension study was designed to evaluate long-term safety, tolerability, and efficacy of dalfampridine-ER (extended release) in adult subjects with chronic post-ischemic stroke walking deficits. Subjects who had completed the placebo-controlled DALF-PS-1016 core study were eligible to enroll regardless of whether they had received active drug or placebo in the core study.|up to 12 months|"The Safety Population of 293 subjects included all subjects who received at least one dose of study treatment.~*One subject was randomized but discontinued the study prior to receiving double-blind study treatment"|||Participants|||Count of Participants
1315454|NCT02421211|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12)|SVR4 or SVR12 is defined as sustained virologic response 4 or 12 weeks after the actual EOT the participant has HCV RNA <LLOQ detectable or undetectable.|4 weeks after EOT (Week 4 of follow-up phase in Panel 1 and Panel 2) and 12 weeks after EOT (Week 12 of follow-up phase in Panel 1 and Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
1315412|NCT02422797|Secondary|Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48 or Withdrawal From the Study|The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0-6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Between and within treatment group comparisons were assessed on change from Baseline treatment satisfaction using the HIV TSQ at Weeks 4, 24 and 48 or withdrawal from the study. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population|||Score on a scale||Full Range|Median
1315413|NCT02422797|Secondary|Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48 or Withdrawal From the Study|The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Between and within treatment group comparisons were assessed on change from Baseline in pre-specified treatment symptoms using the Symptom Distress Module at Weeks 4, 24 and 48 or withdrawal from the study. Change from Baseline in Symptom count and symptom bother score have been summarized. The symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). The symptom bother score ranges from 0 to 80. Last observation carried forward (LOCF) was used as primary method of analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population|||Scores on a scale||Standard Deviation|Mean
1315414|NCT02422797|Secondary|Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1), 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 48|Safety Population|||mmol/ L||Standard Deviation|Mean
1315415|NCT02422797|Secondary|Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Week 48|CVW Population||||||
1315416|NCT02422797|Secondary|Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Week 48|CVW Population||||||
1315417|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized.|Up to 48 weeks|Safety Population|||Participants|||Number
1315418|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized.|Up to 48 weeks|Safety Population|||Participants|||Number
1315419|NCT02422797|Secondary|Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) was summarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to 48 weeks|Safety Population|||Participants|||Number
1315483|NCT02420951|Secondary|Pain Med Consumption Assessed Using Questionnaire/Hospital Records|Questionnaire/Hospital Records - While patients are in the hospital, pain medication consumption will be tracked in their electronic medical record. At home, patients will be asked to keep a log of pain medication consumption. They will be asked to record this information on a questionnaire at their first post-operative visit.|2 days||||morphine milligram equivalents (mgs)||Full Range|Mean
1315420|NCT02422797|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class|Blood for CD4 cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 48|ITT-E Population|||Cells per mm^3||Standard Deviation|Mean
1315421|NCT02422797|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using cochran-mantel haenszel test stratified by current antiretroviral third-agent class. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|ITT-E Population|||Percentage of participants|||Number
1315422|NCT02422797|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV|Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all subjects. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose at Week 2, 4 and 8|PK Parameter NNRTI Subset extra sampling Population|||ug/ L||Standard Deviation|Mean
1315423|NCT02422797|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 4, 24 and 48 or Withdrawal in Participants Switching to DTG + RPV|Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24 and 48. Pre-dose concentrations of DTG and RPV at Weeks 4, 24 and 48 or withdrawal were summarized for the participants switching to DTG + RPV in the early switch phase. Pharmacokinetic (PK) Parameter Population consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0). Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose at Week 4, 24 and 48 or at withdrawal visit|PK Parameter Population|||ug/ L||Standard Deviation|Mean
1315424|NCT02422797|Secondary|Phenotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria|Phenotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicates Not applicable based on drugs were not received. Phenotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.|Week 48|CVW Population|||Participants|||Number
1315425|NCT02422797|Secondary|Genotypic Resistance Data for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria|Genotypic resistance data for drugs received for participants meeting confirmed virologic withdrawal criteria are presented below. Confirmed Virologic Withdrawal (CVW) Population consisted of all participants in the ITT-E Population who met CVW (1 CVW per arm). NA indicates Not applicable based on drugs were not received. Genotypic Resistance Data only shown for Drugs Received for Participants Meeting Confirmed Virologic Withdrawal Criteria.|Week 48|CVW Population|||Participants|||Number
1315426|NCT02422797|Secondary|Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48|Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||Millimoles (mmol)/ L||Standard Deviation|Mean
1315427|NCT02422797|Secondary|Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple , inexpensive , and reliable surrogate measure of insulin resistance.|Up to Week 48|Safety Population|||HOMA-IR Score||Standard Deviation|Mean
1315428|NCT02422797|Secondary|Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||Nanograms (ng)/L||Standard Deviation|Mean
1315429|NCT02422797|Secondary|Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Up to Week 48|Safety Population|||Microgram (ug)/ L||Standard Deviation|Mean
1315484|NCT02420951|Primary|Pain Assessed Using the VAS 0-10 Pain Scale|Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain.|7 days||||units on a scale||Full Range|Mean
1315431|NCT02422797|Secondary|Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles). For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Up to Week 48|Safety Population|||Nanomoles (nmol)/ L||Standard Deviation|Mean
1315432|NCT02422797|Secondary|Mean Change From Baseline in Urine Phosphate at Week 48|Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||Millimoles (mmol)/ L||Standard Deviation|Mean
1315433|NCT02422797|Secondary|Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||mg/ deciliter (dL)||Standard Deviation|Mean
1315434|NCT02422797|Secondary|Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||Microgram/Liter||Standard Deviation|Mean
1315435|NCT02422797|Secondary|Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Week 48|Safety Population|||Nanogram/milliliter||Standard Deviation|Mean
1315436|NCT02422797|Secondary|Mean Change From Baseline in D-Dimer at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||Nanomole (nmol)/L FEU||Standard Deviation|Mean
1315437|NCT02422797|Secondary|Mean Change From Baseline in Cystatin C at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||mg/L||Standard Deviation|Mean
1315438|NCT02422797|Secondary|Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Up to Week 48|Safety Population|||mg/ Liter (L)||Standard Deviation|Mean
1315439|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized.|Up to 48 weeks|Safety Population|||Participants|||Number
1315440|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks|Blood samples were collected at Baseline (Day 1) and at Week 4, 8, 12, 24, 36 and 48 to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade and grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.|Up to 48 weeks|Safety Population|||Participants|||Number
1315441|NCT02422797|Secondary|Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with common non-serious AE, SAE, drug related AE or SAE, AELD or AE with maximum grade toxicity was summarized. Common AEs were those with >5 percent incidence for either treatment. Safety Population included all randomly assigned participants who have received at least one dose of study drug.|Up to Week 52|Safety Population|||Participants|||Number
1315442|NCT02422797|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for HIV-1 RNA at Baseline(Day 1), Week 4, 8, 12 and 24.|Week 24|ITT-E Population|||Percentage of participants|||Number
1315443|NCT02422797|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48|Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48 to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. The full set of lymphocyte sub sets was not evaluated. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and 48|ITT-E Population|||Cells per millimeter (mm)^3||Standard Deviation|Mean
1315444|NCT02422797|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for HIV-1 RNA at Week 0 (Day 1), Week 4, 8, 12, 24, 36 and 48. Treatment with DTG + RPV were declared non-inferior to CAR if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 lies above -10% by Cochran-Mantel Haenszel test. The Intent-to-Treat Exposed (ITT-E) population consisted of all randomly assigned participants who received at least one dose of study drug.|Week 48.|ITT-E Population|||Percentage of participants|||Number
1315445|NCT02422446|Primary|Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)|Change in endothelial function between baseline value and 12-week value|Between baseline and 12 weeks||||% change from baseline value||Full Range|Mean
1315446|NCT02422303|Primary|Depression Score Using Goldberg Depression Screening Test|"The Goldberg screening test consists of 18 questions which are answered based upon the previous 10-14 days to assess depression:~0-not at all~just a little~somewhat~moderately~quite a lot~very much~The scores are summed, and the ranges are assessed:~0 – 9 No depression likely 10 – 21 Possible symptoms that may be due to depression or other medical issues.~22 – 35 Mild to Moderate Depression. 36 – 53 Moderate to Severe Depression 54 and up Severely Depressed The higher the score, the more severe you depression is likely to be."|One week|Participant data were destroyed at study termination, and no analysis was performed, since no longer available.||||||
1315447|NCT02421419|Secondary|Number of Participants With Adverse Effects|Incidence of adverse effects|Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.|Adverse effects was collected on all study participants except for the one patient who was withdrawn after enrollment (CSS group)|||Participants|||Count of Participants
1315448|NCT02421419|Secondary|Degree of Triggering|A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint.|Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey|Data collected on all subjects enrolled except for one that was withdrawn after enrollment.|||Participants|||Count of Participants
1315449|NCT02421419|Secondary|Presence of Triggering|Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected.|Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection|All participants from three groups were asked this question. Data was not collected on subject (CSS group) that withdrew from study after enrollment.|||Participants|||Count of Participants
1315450|NCT02421419|Primary|VAS|Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).|Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection|VAS was collected on all study participants except for the one patient (CSS group) who was withdrawn after enrollment and before any measurements were taken.|||units on a scale||Standard Deviation|Mean
1315451|NCT02421211|Secondary|Number of Participants Not Achieving Sustained Virologic Response (SVR) Showing Emerging Mutation in HCV Nonstructural Protein 3/4A (NS3/4A), Nonstructural Protein 5A (NS5A), and Nonstructural Protein 5B (NS5B) Sequence||Up to end of follow-up phase (Week 12 of follow-up phase) in Panel 1 and Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Since the data was to be analysed in the participants who did not achieve SVR, but all the participants achieved SVR in the study. Therefore the data was not collected for this outcome measure.||||||
1315452|NCT02421211|Secondary|Percentage of Participants With Viral Relapse|Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.|Up to Week 12 follow-up phase after EOT|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
1315453|NCT02421211|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been <LLOQ while on treatment; 2) Other with confirmed detectable HCV RNA at the actual end of treatment (example, completed, discontinued due to AEs, withdrawal of consent).|Day 70 in Panel 1 and Day 56 in Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
1315517|NCT02420041|Primary|Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|2 weeks post-procedure minus baseline||||units on a scale||Full Range|Mean
1315455|NCT02421211|Secondary|Percentage of Participants With On-treatment Virologic Response|"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: less than (<) lower limit of quantification (LLOQ) undetectable, <LLOQ detectable and <LLOQ undetectable/detectable."|Week 1, up to EOT (Week 10 in Panel 1 and Week 8 in Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
1315456|NCT02421211|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 10 Weeks for Panel 1 and 8 Weeks for Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||number of participants|||Number
1315457|NCT02421211|Secondary|Fluctuation Index (FI) of Ledipasvir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||percentage fluctuation||Standard Deviation|Mean
1315458|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1315459|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Hour||Full Range|Median
1315460|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Ledipasvir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1315461|NCT02421211|Secondary|Fluctuation Index (FI) of Simeprevir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||percentage fluctuation||Standard Deviation|Mean
1315462|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1315463|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||hour (H)||Full Range|Median
1315464|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Simeprevir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The Intent-to-treat (ITT) analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
1315465|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir|AUCtau is defined as area under the analyte concentration versus time curve during dosing interval tau, calculated by linear-linear trapezoidal summation.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng*h/mL||Standard Deviation|Mean
1315466|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Ledipasvir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1315467|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1317520|NCT02361736|Secondary|Concentration of β2 Microglobulin in Urine||-1d, 0d, 1d, 3d, 5d after surgery||||mg/L||Standard Deviation|Mean
1315468|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir|The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||nanogram hour per Milliliters (ng*h/mL)||Standard Deviation|Mean
1315469|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Simeprevir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1315470|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Simeprevir (SMV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
1315471|NCT02421146|Secondary|Cognition on the RBANS ( Repeatable Battery for the Assessment of Neuropsychological Status) Scale. Change Between 26th Day and Baseline.|"Standard neuropsychological assessment taking approximately 30 minutes. We report here the total score ndifference between 26th day and baseline. Scores at 26th day and at baseline are calculated according to the RBANS standards as the following: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. For the detailed procedures and ranges please see: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 20 (3): 310–9. doi:10.1076/jcen.20.3.310.823. PMID 9845158. It is a simple delta score: calculating the difference between 26th day and baseline."|baseline (0th day), 26th day||||units on a scale||Standard Deviation|Mean
1315472|NCT02421146|Primary|Cognition on the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) Scale|"Standard neuropsychological assessment taking approximately 30 minutes. We report here the total score ndifference between 12th day and baseline. Scores at 12th day and at baseline are calculated according to the RBANS standards as following: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. For the detailed procedures and ranges please see: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 20 (3): 310–9. doi:10.1076/jcen.20.3.310.823. PMID 9845158. It is a simple delta score: calculating the difference between 12th day and baseline."|baseline (0th day), 12th day|We calculated differences in the cognitive measure (RBANS TScore) before and after tDCS treatment.|||units on a scale||Standard Deviation|Mean
1315473|NCT02421120|Secondary|Safety and Tolerability (Changes in Serum Chemistry, Hematology and Hepatic Lab Values, as Well as Reported Adverse Events)|This outcome will assess the safety and tolerability of ceftolozane/tazobactam in adults with CF after 4-6 doses, as measured by changes in serum chemistry, hematology and hepatic lab values, as well as reported adverse events by patients and providers.|3 days|||||||
1315474|NCT02421120|Secondary|Ceftolozane Probability of Target Attainment at 8 mcg/ml|This simulated outcome indicates the likelihood that ceftolozane will retain drug concentrations above the MIC for >/= 60% of the dosing interval at an MIC of 8 mcg/ml when administered as a 3g (2g ceftolozane/1g tazobactam) every 8 hour dose infused over 1 hour. This analysis is conducted via a Monte Carlo simulation using the population pharmacokinetic parameter estimates and dispersion from the 20 participants who contributed pharmacokinetic data to the study.|24 hours|The results of this analysis are based on 5000 simulated patients with the same pharmacokinetics to the 20 enrolled participants.|||percent of simulated population|||Number
1315475|NCT02421120|Primary|Tazobactam Volume of Distribution (Central Compartment)|This outcome determines the volume of distribution of tazobactam over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters||Standard Deviation|Mean
1315476|NCT02421120|Primary|Tazobactam Clearance|This outcome determines the clearance of tazobactam over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters per hour||Standard Deviation|Mean
1315477|NCT02421120|Primary|Ceftolozane Volume of Distribution (Central Compartment)|This outcome determines the volume of distribution of ceftolozane over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters||Standard Deviation|Mean
1315478|NCT02421120|Primary|Ceftolozane Clearance|This outcome determines the clearance of ceftolozane over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters per hour||Standard Deviation|Mean
1315479|NCT02420951|Secondary|"Quadriceps Strength Measured Using a Biodex Handheld Dynamometer"|Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer.|7 days|Data were not collected.||||||
1315480|NCT02420951|Secondary|Proprioception Measured Using a SD Balancer|Proprioception measured after surgery, as measured by an SD balancer.|7 days|Data were not collected.||||||
1315481|NCT02420951|Secondary|Swelling Measured Using a Perometer|Swelling in the affected TKR joint, as measured by a perometer.|7 days|Data were not collected.||||||
1315482|NCT02420951|Secondary|Pain Med Consumption Assessed Using Questionnaire/Hospital Records|Total pain medications consumed by the patient, determined through the patients' own records in the questionnaire as well as hospital records of pain med administration and prescription.|7 days|Data were not collected.||||||
1315518|NCT02420041|Primary|Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|30 minutes pre-procedure minus baseline||||units on a scale||Full Range|Mean
1315485|NCT02420873|Primary|Overall Response Rate (ORR) of IMGN901 in Participants CD56 Expressing Hematological Malignancies|ORR, defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 cycles of therapy with IMGN901.|53 days|Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).|||Participants|||Count of Participants
1315486|NCT02420327|Secondary|Profile of Mood Scale - Total Mood Disturbance|"Participants rate their current subjective state on a list of adjectives, which contribute to six factors/subscales. Total Mood Disturbance is a composite measure, obtained by summing the scores of all subscales, each with a range of 0-4, weighting the one positively valenced factor negatively. Thus, smaller or more negative values represent a more positive mood state. The theoretical range of the Total Mood Disturbance measure is from -4 to +20."|5 min|Healthy adult non-smokers|||score on a scale||Standard Deviation|Mean
1315487|NCT02420327|Primary|Change Detection Task Reaction Time|"The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color.~One participant's data were excluded from this task because of excessive no-response trials."|15 min|Healthy adult non-smokers|||ms||Standard Deviation|Mean
1315488|NCT02420327|Primary|Rapid Visual Information Processing Task Reaction Time|The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits.|30 min|Healthy adult non-smokers|||ms||Standard Deviation|Mean
1315489|NCT02420327|Primary|Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time|The task requires responding to brief target stimuli presented randomly in one of four locations in the four corners of the screen. On non-predictive trial, the cue does not provide any advance information about where the target will occur.|45 min|Healthy adult non-smokers|||ms||Standard Deviation|Mean
1315490|NCT02420327|Primary|Change Detection Task Accuracy|"The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. Accuracy refers to the percentage of all trials in which a correct response was given.~One participant's data were excluded from this task because of excessive no-response trials."|15 min|Healthy adult non-smokers|||percentage of all trials||Standard Deviation|Mean
1315491|NCT02420327|Primary|Rapid Visual Information Processing Task Hit Rate|The task requires following a stream of digits and detecting three consecutive odd or even numbers. The Hit Rate reflects the percentage of all target sequences that were detected.|30 min|Healthy adult non-smokers|||percentage of all targets||Standard Deviation|Mean
1315492|NCT02420327|Primary|Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time|The task requires detecting brief target stimuli presented at one of four locations in the four corner of the screen. On predictive trials, a central cue predicts the target location.|45 min|27 healthy adult non-smokers|||ms||Standard Deviation|Mean
1315493|NCT02420262|Secondary|Responder for HbA1c Below or Equal to 6.5 %|Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.|After 26 weeks of treatment|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Participants|||Count of Participants
1315494|NCT02420262|Secondary|Responder for HbA1c Below 7.0%|Number of subjects with HbA1c below 7% after 26 weeks of treatment.|After 26 weeks of treatment|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Participants|||Count of Participants
1315495|NCT02420262|Secondary|Change in Body Weight|Change in body weight after 26 weeks of treatment.|Week 0, Week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 08 subjects in both IDegLira and IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||kg||Standard Error|Least Squares Mean
1315496|NCT02420262|Secondary|Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.|Weeks 0-26|The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. One subject in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Number of episodes|||Number
1315497|NCT02420262|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change in HbA1c values after 26 weeks of treatment.|Week 0, Week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 8 subjects in IDegLira and 9 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1315498|NCT02420210|Other Pre-specified|Quality of Life Assessed Using the Functional Assessment of Cancer Therapy (FACT)-L Scale||Up to 18 weeks (at end of study treatment)|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
1315499|NCT02420210|Secondary|Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Adverse events will be tabulated by type and grade.|Up to 30 days following the last administration of study treatment|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
1315500|NCT02420210|Secondary|Progression Free Survival|Kaplan-Meier analysis will be performed. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better PFS.|From date of study entry (date of first treatment) until progression, secondary malignancy, or death from any cause, assessed at 2 years|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
1315616|NCT02417376|Secondary|Change From Baseline in C-Reactive Protein Level at 3 Month|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months.|Baseline and 3 months||||mg/L||Standard Deviation|Mean
1315501|NCT02420210|Secondary|Overall Survival (OS)|Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).|From date of study entry (date of first treatment) until death from any cause, assessed at 3 years|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
1315502|NCT02420210|Secondary|Overall Survival|Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).|From date of study entry (date of first treatment) until death from any cause, assessed at 2 years|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
1315503|NCT02420210|Secondary|Feasibility, Defined as Completing All Required Geriatric Assessments Where Applicable Per the Protocol in 80% or More of the Enrolled Eligible Patients||Up to 40 months|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
1315504|NCT02420210|Primary|ORR (PR + CR) Using the Cheson et al Parameters|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 8 months||||Participants|||Count of Participants
1315505|NCT02420093|Primary|Change in Numeric Pain Rating Scale|"This questionnaire measures subjective perception of pain levels on a 0-10 (11 point) scale, with 0 being no pain and 10 being the worst pain imaginable."|Change from Baseline after 3 Weeks||||units on a scale||Standard Error|Mean
1315506|NCT02420093|Primary|Change in Fingertip to Floor Flexibility Test|This test measures subjects flexibility in forward trunk bending while subject is standing on a block 20 cm high. Measurement is in centimeters from fingertip to edge of step, above or below the step edge.|Baseline and 3 Weeks||||centimeters||Standard Error|Mean
1315507|NCT02420093|Primary|Change in Sorenson Test for Lumbar Muscle Endurance|This test measures a persons back strength in 1 repetition of holding a back posture in neutral as long as can while lying on their stomach, legs stabilized on a treatment table.|Baseline and 3 Weeks||||time in seconds||Standard Deviation|Mean
1315508|NCT02420093|Primary|Change in Left and Right Hamstring Length Testing|This test measures left and right hamstring length of the subject while they are lying on their back. The angle between the femur and tibia/fibula were measured when the hip angle held constant at 90 degrees and knee in full amount of available knee extension. This measure will use inclinometers for measurement.|Baseline and 3 Weeks||||degrees||Standard Error|Mean
1315509|NCT02420093|Primary|Change in Modified Oswestry Low Back Pain Disability Index|This questionnaire measures the impact subject's low back pain on functional tolerance levels. Scale range is 0-100 with the lower score indicating a higher functional / activity level as it relates to Low Back Pain.|Baseline and 3 Weeks||||units on a scale||Standard Error|Mean
1315510|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale of satisfaction||Full Range|Mean
1315511|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale of satisfaction||Full Range|Mean
1315512|NCT02420041|Secondary|Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
1315513|NCT02420041|Secondary|Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
1315514|NCT02420041|Secondary|Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
1315515|NCT02420041|Secondary|Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
1315516|NCT02420041|Primary|Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|3 months post-procedure minus baseline|numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study|||units on a scale||Full Range|Mean
1315520|NCT02419937|Primary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|30 day rate of major adverse cardiac events (MACE) following administration of Tocilizumab subcutaneously single dose within 24 hours of NSTEMI or STEMI as compared to administration of placebo|30 days after one time injection|Major Adverse Cardiac Events (MACE) for those gathered 30 days after receiving medication or placebo|||Participants|||Count of Participants
1315521|NCT02419755|Other Pre-specified|Minimal Residual Disease (MRD)|"MRD will be monitored until the completion of therapy (up to 500 days) for patients that do not go on to bone marrow transplant. If a patient goes on to receive a bone marrow transplant, at that point, they will no longer be monitored for minimal residual disease.~Concordance and associations of the MRD levels across three modalities (flow cytometry, PCR, and deep sequencing) as continuous measurements will be assessed by Pearson’s and Spearman’s correlations and Kendall’s tau; MRD levels categorized into ordinal values will be analyzed by contingency tables with or without ordered margins."|Various time points until completion of therapy (up to 18 months)|Data was either not collected or is incomplete for each of the 10 participants, and therefore cannot be analyzed.||||||
1315522|NCT02419755|Other Pre-specified|Frequency of Identified Genomic Lesions|Frequencies of the identified lesions will be described by counts and proportions. An established method (Pounds et al., 2013) will be applied to identify genes and pathways frequently hit by the genomic lesions.|Once at enrollment|The investigator is unable to identify frequency of genomic lesions. To obtain useful information, a much larger sample size is needed. Genomic sequencing is cost-prohibitive to be performed on this small sample size where there are too few samples to obtain any useful information.||||||
1315523|NCT02419755|Secondary|Number of Relevant Toxicities Related to Therapy|"Events were graded using CTCAE v. 4.0. All toxicities will be monitored until the completion of therapy (up to 500 days) for patients that do not go on to bone marrow transplant. If a patient goes on to receive a bone marrow transplant, at that point, they will no longer be monitored for toxicity, as any further toxicities may be secondary to the transplant and not the study regimen.~This outcome reports those toxicities that are that were possibly, probably or definitely related to therapy. Participants were separately monitored for frequency of grade 5 events, grade 4 sepsis, grade 4 hemorrhage, and grade 4 hepatic toxicity across all patients in the stratum. Grade 4 and 5 events that are clearly and incontrovertibly due to extraneous causes or disease progression will be excluded. Higher grade events are considered more severe than lower grade."|From on-therapy date up to 18 months|Although only 3 Stratum 1 and 4 Stratum 2 participants completed the trial, there were 4 Stratum 1 participants and 6 Stratum 2 participants evaluable for this outcome measures.|||events|||Number
1315524|NCT02419755|Secondary|Number of Participants With 10-year Overall Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Ten years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
1315525|NCT02419755|Secondary|Number of Participants With 5-year Overall Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Five years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
1315526|NCT02419755|Secondary|Number of Participants With 3-year Overall Survival (OS)|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Three years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
1315527|NCT02419755|Secondary|Number of Participant With 10-year Event Free Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Ten years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
1315528|NCT02419755|Secondary|Number of Participants With 5- Year Event Free Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Five years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
1315529|NCT02419755|Secondary|Number of Participants With 3 Year Event Free Survival (EFS)|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Three years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
1315530|NCT02419755|Primary|Overall Response Rate in All Participants|"For the purpose of the statistical analysis of the primary objective, response is assessed at the end of first treatment block at maximum tolerated dose of vorinostat (i.e., Induction Ia or Ib for myeloid and Induction for lymphoid and mixed lineage). Any eligible patient who starts first treatment block is considered evaluable. Response of CR, CRi, PR, or PRi is considered a success; otherwise a failure, which will include the cases of No-response, as well as off- treatment or off-study before response can be assessed, except cases found ineligible after enrollment. A patient found ineligible after enrollment will be taken off study and replaced by enrolling an additional MLLr patient.~The rate (probability) of response will be estimated by the sample proportion of patients who responded (CR, CRi, PR, PRi) to Induction, along with the 99% confidence interval and lower confidence bound. Three interim analyses will be performed to monitor the possible lack of efficacy."|End of first treatment block (up to 2 months)|The determination of overall response rate is contingent on the determination of the maximum tolerated dose. The study was terminated before the maximum tolerated dose was determined. Therefore, response rate cannot be calculated.||||||
1315531|NCT02419521|Secondary|Cardiac Death and TVMI||8 Months||||Participants|||Count of Participants
1315532|NCT02419521|Secondary|Stent Thrombosis (ST)||8 Months||||Participants|||Count of Participants
1315533|NCT02419521|Secondary|Target Vessel Failure (TVF)||8 Months||||Participants|||Count of Participants
1315534|NCT02419521|Secondary|Target Lesion Failure (TLF)||8 Months||||Participants|||Count of Participants
1315535|NCT02419521|Secondary|Major Adverse Cardiac Event (MACE)|Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods|8 Months||||Participants|||Count of Participants
1315536|NCT02419521|Secondary|Target Lesion Revascularization (TLR)||8 Months||||Participants|||Count of Participants
1315537|NCT02419521|Secondary|Target Vessel Myocardial Infarction (TVMI)||8 Months||||Participants|||Count of Participants
1315538|NCT02419521|Secondary|Cardiac Death||8 Months||||Participants|||Count of Participants
1315539|NCT02419521|Primary|In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography|In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography|8 Months||||mm||Standard Deviation|Mean
1315540|NCT02419469|Primary|Event Free Survival (EFS)|Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.|3 years||||Participants|||Count of Participants
1315541|NCT02419313|Secondary|Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale|This scale measures the amplitude of the tremor. For instance tremor of more than 4cm oscillation is grade 4. UPDRS tremor scale is 0-4 , 4 being severe tremor. Significant improvement for this protocol considered two grades of improvement .|4 Weeks||||participants|||Number
1315542|NCT02419313|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks||||participants|||Number
1315543|NCT02419313|Primary|Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale|The primary outcome measure in this protocol is significant improvement of tremor (equal or over 2 grade improvement) of the Unified Parkinson's Disease Rating Scale 4 weeks after Xeomin injection. The score is 0 to 4 , ) being no tremor and 4 severe tremor. The higher the score, the more severe the tremor.|4 weeks||||participants|||Number
1315544|NCT02419001|Primary|Ceftriaxone PK Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) With (Period 2) and Without (Period 1) SYN-004.||2 weeks||||h*ng/mL||Standard Deviation|Mean
1315545|NCT02419001|Primary|Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.|Samples were collected at 0.25 h, 0.5 through 2 h, and 3 through 7 h after the infusion start. Standard deviations may be 0 if all collected T max values occur at the same time.|2 weeks||||hours||Standard Deviation|Mean
1315546|NCT02419001|Primary|Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.||2 weeks||||ng/mL||Standard Deviation|Mean
1315567|NCT02417961|Secondary|The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive|Baseline until Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Number
1317521|NCT02361736|Primary|Concentration of IL-18 in Plasma on 5 Time Point||-1d, 0d, 1d, 3d, 5d after surgery||||μg/L||Standard Deviation|Mean
1315547|NCT02418676|Secondary|Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients|Dosages were provided four times daily (04h, 10h, 16h and 22h) to each patient during the 15-day study period, giving a total of 60 doses. To obtain these dosages, a drop of blood of patients was placed on a colorimetric strip and blood glucose was measured with the use of an Accu Check Active® glucose meter. The mean of 60 dosages was calculated for each patient at the end of 15 days. For each group assessed, it was calculated the mean of the measurements of the five patients, resulting in a single value.|Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study.|||mg/dL||95% Confidence Interval|Mean
1315548|NCT02418676|Primary|Efficacy Index (%EI)|Every three days the pressure ulcers (PUs) of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos were evaluated for measurement of PUs and any kind of irritation. At the end of this stage, the properly gathered study data was interpreted using the analysis software Mobile Wound Analyzer® (MOWA). Healing efficacy indices (% EI) were calculated as percentage reduction in the wound size at days 3, 6, 9, 12 and 15 from treatment beginning (d0). The % EI of the wound size was calculated by the following equation: %EI= ((Vsp.day-Vi)/Vi))x100. Vsp.day refers to the diameter (mm) values measured at day 3, 6, 9,12 and 15, while Vi refers to the baseline value measured before treatment (d0). The most representative result of treatment efficacy was observed on day 15, therefore it was used to calculate the % EI. For each group assessed, it was calculated the mean % EI of the five patients, resulting in a single value.|Measured every 3 days for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with little tissue loss, and allow easy visualization of healing.|||percentage (%)||95% Confidence Interval|Mean
1315549|NCT02418468|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks|To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.|at week 12|Full Analysis Set (FAS) - would include all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients would be analyzed according to the treatment assigned at randomization.|||Liters||Standard Error|Least Squares Mean
1315550|NCT02418234|Secondary|Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure|The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years||||percentage of total ctDNA||Full Range|Median
1315551|NCT02418234|Secondary|Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure|The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years||||participants|||Number
1315552|NCT02418234|Primary|Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient|The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.|up to 2 years||||percentage of total ctDNA||Full Range|Median
1315553|NCT02418234|Primary|Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay|The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).|up to 2 years||||participants|||Number
1315554|NCT02418026|Secondary|Non-steroidal Anti-inflammatory Drug Intake||day 3||||participants|||Number
1315555|NCT02418026|Secondary|Mean Pulse||for 2 hours in the recovery room at regular intervals (average)||||bpm||Standard Deviation|Mean
1315556|NCT02418026|Secondary|Mean Pulse||during surgery (average), up to 2 hours||||bpm||Standard Deviation|Mean
1315557|NCT02418026|Secondary|Mean Pulse||preoperative, up to 2 hours||||bpm||Standard Deviation|Mean
1315558|NCT02418026|Secondary|Mean Blood Pressure||for 2 hours in the recovery room at regular intervals (average)||||mm Hg||Standard Deviation|Mean
1315559|NCT02418026|Secondary|Mean Blood Pressure||during surgery (average), up to 2 hours||||mm Hg||Standard Deviation|Mean
1315560|NCT02418026|Secondary|Mean Blood Pressure||preoperative, up to 2 hours||||mm Hg||Standard Deviation|Mean
1315561|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable)|day 3||||units on a scale||Standard Deviation|Mean
1315562|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|day 1||||units on a scale||Standard Deviation|Mean
1315563|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|just after surgery, up to 1 hour||||units on a scale||Standard Deviation|Mean
1315564|NCT02418026|Secondary|Wellbeing Measured Using a Comfort Scale|The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to “no comfort” and 10 corresponds to “most comfortable”.|Day 3||||units on a scale||Standard Deviation|Mean
1315565|NCT02418026|Secondary|Wellbeing Measured Using a Comfort Scale|The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to “no comfort” and 10 corresponds to “most comfortable”.|Day 2||||units on a scale||Standard Deviation|Mean
1315566|NCT02418026|Primary|Wellbeing Measured Using a Comfort Scale|The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to “no comfort” and 10 corresponds to “most comfortable”.|just after surgery, up to 1 hour||||units on a scale||Standard Deviation|Mean
1315568|NCT02417961|Secondary|The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels|Blood eosinophil counts by timepoint|Baseline, Week 20, and Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||cells/ uL||Standard Deviation|Mean
1315569|NCT02417961|Secondary|The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 8, Week 20, and Week 28|PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1315570|NCT02417961|Secondary|The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score|The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.|Week 0 (baseline) and weeks 4, 8, 12, 16, 20|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Scores on a scale||Standard Deviation|Mean
1315571|NCT02417961|Primary|Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)|Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.|Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16|Number of Units analyzed per row represents number of accessorized pre-filled syringes used at each time point.|||Accessorized Pre-filled Syringe|Accessorized Pre-filled Syringe||Count of Units
1315572|NCT02417961|Primary|Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional|Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of “Yes” to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point.|Week 12, Week 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Count of Participants
1315573|NCT02417961|Primary|Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home|Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of “Yes” to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point.|Week 12, Week 16, and Weeks 12 and 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Count of Participants
1315574|NCT02417935|Secondary|Number of Participants With a 30% and 50% Reduction in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point NRS at 12 Weeks|11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score.|Week 12|All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for average pain score NRS .|||Participants|||Count of Participants
1315575|NCT02417935|Secondary|Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS|"24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score.~MMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for worst pain score NRS.|||units on a scale||Standard Error|Least Squares Mean
1315576|NCT02417935|Secondary|Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS|"Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score.~MMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for night pain NRS.|||units on a scale||Standard Error|Least Squares Mean
1315577|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score|"Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.~MMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BDI-II.|||units on a scale||Standard Error|Least Squares Mean
1315578|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D)|"The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state.~ANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline observation for EQ-5D.|||units on a scale||Standard Error|Least Squares Mean
1315579|NCT02417935|Secondary|Clinical Global Impression of Improvement (CGI-I) at 12 Weeks|"CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean."|Week 12|All randomized participants who received at least one dose of study drug and had at least one post baseline observation for CGI-I|||units on a scale||Standard Error|Least Squares Mean
1315580|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)|"NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for NPSI.|||units on a scale||Standard Error|Least Squares Mean
1315581|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)|"Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.~MMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BPI-SF.|||units on a scale||Standard Error|Least Squares Mean
1315582|NCT02417935|Secondary|Patient Global Impression of Improvement (PGI-I) at 12 Weeks|"PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean."|Week 12|All randomized participants who received at least one dose of study drug and had at least one post baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1315583|NCT02417935|Primary|Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS)|"11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).~Mixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean)."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for NRS.|||units on a scale||Standard Error|Least Squares Mean
1315584|NCT02417753|Secondary|Overall Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150|OS is defined as the time from the first day of treatment to the day of death.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
1315585|NCT02417753|Secondary|Progression Free Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150|PFS is the time interval from start of treatment to documented evidence of progressive disease. Progressive disease was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). in addition to the relative increase of 29%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
1315586|NCT02417753|Secondary|Count of Participants With Serious and Non Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 months and 15 days||||Participants|||Count of Participants
1315587|NCT02417753|Secondary|Response Rate (RR) in Patients With Malignant Ascites Treated With AZD9150|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is measured from the time measurement criteria are met for complete response or partial response (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
1315615|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 1 Month|Change from baseline in lipid profile assessed at 1 month.|Baseline and 1 month||||mg/dl||Standard Deviation|Mean
1315588|NCT02417753|Secondary|Reduction in Tyrosine-phosphorylated Signal Transducer and Activator of Transcription 3 (STAT3) Phospho- Signal Transducer and Activator of Transcription 3 (p- STAT3) Expression, Comparing Before and After Therapy, in Ascites and Peripheral Blood|Measure the reduction in tyrosine-phosphorylated STAT3 (p=STAT3) expression.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
1315589|NCT02417753|Secondary|Effect on Signal Transducer and Activator of Transcription 3(STAT3)-Dependent & Associated Signaling Both in Tumor Cells, Peripheral Blood and the Microenvironment, Including Modulations in Chemokine and Cytokine Response Following Treatment With AZD9150|Serum samples were to be collected from participants and assessed for interferon, cytokine and chemokine levels including interferon, ϒ-interferon inducible protein (IP-10), monocyte chemoattractant protein 1 (MCP-1), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 10 (IL-10), and interleukin 12/p70 (IL-12/p70).|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
1315590|NCT02417753|Primary|Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150|Participants were to undergo research paracentesis. Ascitic fluid was to be obtained and processed for changes in the percentages of memory cluster of differentiation 8 (CD8) + cells, regulatory T cells, plasmacytoid dendritic cell (pDC), B cells and natural killer (NK) cells will be analyzed by flow cytometry.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
1315591|NCT02417532|Secondary|Timed up and go Test- Ability to Stand From Chair|Walk 3 m and turn around and walk back to the chair. (Functional test)|1 Day|Subjects who met all inclusion/exclusion criteria|||Participants|||Count of Participants
1315592|NCT02417532|Secondary|Participant Satisfaction Questionnaire|overall user satisfaction with the device|1 Day|All subjects meeting inclusion criteria|||percentage of patients|||Number
1315593|NCT02417532|Secondary|Competency of User, in First Use, in Autonomous Control of the Device in <10 Minutes|Competent ability of user to use device within the first 10 Minutes without assistance|1 Day|All patients meeting inclusion criteria|||Participants|||Count of Participants
1315594|NCT02417532|Secondary|User Transfer, in First Use|Ability to transfer to Rex in first use of device|1 day|All subjects meeting inclusion criteria|||Participants|||Count of Participants
1315595|NCT02417532|Primary|Adverse Events|absence of unexpected serious adverse events|1 day||||Participants|||Count of Participants
1315596|NCT02417532|Primary|Completion of REXercise 2|Lateral Trunk Extension|1 day|All Subjects meeting inclusion criteria|||Participants|||Count of Participants
1315597|NCT02417532|Primary|Completion of REXercise 1|Bilateral Shoulder Abduction|1 day|All subjects meeting inclusion criteria|||Participants|||Count of Participants
1315598|NCT02417532|Primary|Completion of Transfer|Completion of transfer from wheelchair or bed to REX device|1 day|All subjects meeting inclusion criteria. Physically able to properly fit in REX.|||participants|||Number
1315599|NCT02417376|Secondary|Diastolic Blood Pressure at 6 Months|Diastolic blood pressure at 6 months.|6 months||||mmHg||Standard Deviation|Mean
1315600|NCT02417376|Secondary|Diastolic Blood Pressure at 3 Months|Diastolic blood pressure at 3 months.|3 months||||mmHg||Standard Deviation|Mean
1315601|NCT02417376|Secondary|Diastolic Blood Pressure at 1 Month|Diastolic blood pressure at 1 month.|1 month||||mmHg||Standard Deviation|Mean
1315602|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months|Change from baseline in periodontal parameter- clinical attachment loss at 6 months.|Baseline and 6 months||||mm||Standard Deviation|Mean
1315603|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months|Change from baseline in periodontal parameter- bleeding on probing at 6 months.|Baseline and 6 months||||percentage of sites||Standard Deviation|Mean
1315604|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Plaque Index at 6 Months|Change from baseline in periodontal parameter- plaque index at 6 months. Scale ranges for Total Plaque Index - Minimum score (0) and maximum score (3). Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded.|Baseline and 6 months||||Scores on a scale||Standard Deviation|Mean
1315605|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Gingival Index at 6 Months|"Change from baseline in periodontal parameter- gingival index at 6 months. Scale ranges for Total Gingival Index - Minimum score (0) and maximum score (3).~Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded."|Baseline and 6 months||||Scores on a scale||Standard Deviation|Mean
1315606|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months|Change from baseline in periodontal parameter- periodontal probing depth at 6 months.|Baseline and 6 months||||mm||Standard Deviation|Mean
1315607|NCT02417376|Secondary|Systolic Blood Pressure at 6 Months|Systolic blood pressure at 6 months.|6 months||||mmHg||Standard Deviation|Mean
1315608|NCT02417376|Secondary|Systolic Blood Pressure at 3 Months|Systolic blood pressure at 3 months.|3 months||||mmHg||Standard Deviation|Mean
1315609|NCT02417376|Secondary|Systolic Blood Pressure at 1 Month|Systolic blood pressure at 1 month.|1 month||||mmHg||Standard Deviation|Mean
1315610|NCT02417376|Secondary|Change From Baseline WBC Profile at 6 Months|Change from baseline in white blood cell profile assessed at 6 months.|Baseline and 6 months||||per cmm||Standard Deviation|Mean
1315611|NCT02417376|Secondary|Change From Baseline WBC Profile at 3 Months|Change from baseline in white blood cell profile assessed at 3 months.|Baseline and 3 months||||per cmm||Standard Deviation|Mean
1315612|NCT02417376|Secondary|Change From Baseline WBC Profile at 1 Month|Change from baseline in white blood cell profile assessed at 1 month.|Baseline and 1 month||||per cmm||Standard Deviation|Mean
1315613|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 6 Months.|Change from baseline in lipid profile assessed at 6 months.|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
1315614|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 3 Months|Change from baseline in lipid profile assessed at 3 months.|Baseline and 3 months||||mg/dl||Standard Deviation|Mean
1315617|NCT02417376|Secondary|Change From Baseline in C-Reactive Protein Level at 1 Month|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month.|Baseline and 1 month||||mg/L||Standard Deviation|Mean
1315618|NCT02417376|Primary|Change From Baseline in C-Reactive Protein Level at 6 Months|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.|Baseline and 6 months|All patients suffered from CHD and Periodontitis both.|||mg/L||Standard Deviation|Mean
1315619|NCT02417233|Primary|Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)|"Self-reported ability to take ART as prescribed in last month, assessed at 12 months from enrollment. Considered compliant if reported very good or excellent adherence."|12 months|Analysis population is all enrolled participants prescribed ART who returned to answer the 12 month survey.|||Participants|||Count of Participants
1315620|NCT02417233|Primary|Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)|Viral load test results <400 copies/mL (consistent with current and correct adherence to ART)|12 months|Analysis population is all enrolled participants who were prescribed ART and had received viral load testing by 12 months of study enrollment|||Participants|||Count of Participants
1315621|NCT02417233|Primary|Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)|Participants who return for repeat CD4 testing within 12 months of diagnosis|12 months|Analysis population is all enrolled participants who were not prescribed ART|||Participants|||Count of Participants
1315622|NCT02417233|Primary|Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)|Participants eligible for ART who initiated ART and who remain on treatment 12 months from enrollment. Retention in care at 12 months is defined as at least 4 clinical care visits with less than 4 months between each visit.|12 months|Analysis population is all enrolled participants who were prescribed ART.|||Participants|||Count of Participants
1315623|NCT02417233|Primary|Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)|Participants eligible for ART who initiate treatment within 3 months of diagnosis|3 months|Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment|||Participants|||Count of Participants
1315624|NCT02417233|Primary|Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)|Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)|3 months|Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment|||Participants|||Count of Participants
1315625|NCT02417129|Secondary|Immunogenicity at Week 30|"Immunogenicity (rate of anti-drug antibodies) at Week 30 presented as the number of participants having Immunogenicity at Week 30.~This endpoint was not summarized for arm ' rituximab ', as two patient were randomized and treated with BI 695500, thus no patient was treated with rituximab in this trial."|Day 204 or end of study|Safety Analysis Set (SAF). As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.|||participants|||Number
1315626|NCT02417129|Secondary|Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)|Extrapolated area under the concentration-time curve of BI 695500 or rituximab in plasma at steady state over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ, ss) established by population pharmacokinetics.|Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.||||||
1315627|NCT02417129|Primary|Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab|"The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL).~The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment.~Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial."|From first administration of study medication until 30 weeks thereafter.|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.|||participants|||Number
1315628|NCT02416973|Primary|Percent Change From Baseline in Pain Scores|Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable).|60 days|Per protocol population results displayed. This results in a discrepancy in the number of participants provided above. Baseline characteristics include the entire intent to treat population.|||Percent Difference||Standard Deviation|Mean
1315629|NCT02416934|Secondary|Change in Quality of Life|Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability.|Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.|Neck Disability Index change from baseline to 1 year or last visit as appropriate. Not all subjects followed up at 1 year.|||units on a scale||Standard Error|Mean
1315639|NCT02415959|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||percentage of fat intake||Standard Deviation|Mean
1315630|NCT02416934|Primary|Swallowing Difficulty|Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.|1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months|Treatment 1; Dexamethasone or Treatment 0; Saline placebo. Treatment 1 received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. Dosage was approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 0 received similar volume of saline on same schedule for three doses.|||Participants|||Count of Participants
1315631|NCT02416180|Secondary|Time Taken to Correctly Completing Inhaler Use at Day 14|If a participant made a critical error during the initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The HCP could have demonstrated the use of the inhaler a maximum of three times. Any errors made after this final demonstration were recorded. The time taken for the HCP to train the participant in the correct technique was recorded as T1: the time from when the participants started their demonstration of MDI use until they had completed their demonstration of MDI use (i.e., with no HCP support), T2: the time from when the HCP started to demonstrate/instruct device use until correct use was demonstrated by the participant (up to a maximum of three attempts only). T3 is defined as T1+T2, which is the time from when the participant started to demonstrate MDI use until correct use was demonstrated by the subject (up to a maximum of three attempts following demonstration by HCP).|Day 14|ITT Population|||Minutes||Full Range|Median
1315632|NCT02416180|Secondary|Number of Health Care Professional (HCP) Instructions Required on Day 14|Participant's inhaler use was assessed on Day 14 by the HCP against a predefined list of critical errors. If a participant made a critical error during this initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The participant was then asked to demonstrate inhaler use. Any errors were recorded by the HCP. If the participant made a critical error then the HCP repeated the demonstration of inhaler use to the participant for a second time. If the participant continued to make a critical error in the use of the inhaler, the HCP demonstrated the correct use of the inhaler and gave verbal instructions one more time and the participant was then asked to demonstrate inhaler use. Instructions are only given to subjects who make a critical error. Any errors made after this final demonstration were recorded.|Day 14|ITT Population|||Participants|||Number
1315633|NCT02416180|Secondary|Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14.|Inhaler use was assessed on Day 14 for overall errors. Overall errors included CEs or N-CEs. Demonstration of usage was with MDI and placebo, CE or N-CEs and even no errors were recorded. CEs were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. N-CEs were defined as: failure to inhale within 5 seconds of shaking the device; no exhalation before an inhalation; the inhalation manoeuvre was not slow and/or was not deep; dose coordination was sub-optimal but patient likely to have received some dose; more than one actuation during an inhalation manoeuvre; did not hold breath. The exact 95% confidence interval is for percent of participants making at least one CE after the first assessment of the MDI technique, and was calculated using exact binomial distribution.|Day 14|ITT population|||Percentage of participants||95% Confidence Interval|Number
1315634|NCT02416180|Primary|Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14|Participant's inhaler use was assessed on Day 14 by the health care professional (HCP) against a predefined list of critical errors (CEs). Critical errors were defined as errors that were most likely to result in no or only minimal medication being inhaled. The participants were asked to demonstrate their usage of the MDI using a placebo demonstration MDI by HCP, critical or non-critical errors (N-CEs) and even no errors made by the participants while using the MDI were recorded. Critical errors in using the MDI were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. 95% confidence interval (CI) is for the % of participants making at least one critical error after the first assessment of the MDI technique, and was calculated using the exact binomial distribution.|Day 14|Intent to Treat (ITT) population: comprised of all participants who were screened and received at least one dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
1315635|NCT02415959|Other Pre-specified|Treatment Emergent Adverse Events|Treatment emergent adverse events will be summarized per treatment group|From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days||||participants|||Number
1315636|NCT02415959|Secondary|Stool Weight|Total amount of stool weight during the collection period in grams|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||gram per 72 hours||Standard Deviation|Mean
1315637|NCT02415959|Secondary|Stool Fat Content|Total amount of fat excreted during the stool collection period in grams.|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||gram per 72 hours||Standard Deviation|Mean
1315638|NCT02415959|Secondary|Coefficient of Nitrogen Absorption (CNA)|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||percentage of nitrogen intake||Standard Deviation|Mean
1315640|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days||||(ng/mL)||Standard Deviation|Mean
1315641|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)||Participants will be followed for the duration of hospital stay of 15 days||||(hr*ng/mL)||Standard Deviation|Mean
1315642|NCT02415439|Primary|Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days||||participants|||Number
1315643|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days||||(ng/mL)||Standard Deviation|Mean
1315644|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)||Participants will be followed for the duration of hospital stay of 4 days||||(hr*ng/mL)||Standard Deviation|Mean
1315645|NCT02415439|Primary|Number of Subjects With Adverse Effects After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days||||participants|||Number
1315646|NCT02415166|Other Pre-specified|DIAGNOSTIC GROUP DIFFERENCES IN THE BOLD RESPONSE (Using fMRI) TO MONETARY REWARDS IN THE VENTRAL STRIATUM||2 DAYS|||||||
1315647|NCT02415166|Other Pre-specified|DIFFERENCES IN RESTING STATE CEREBRAL BLOOD FLOW BETWEEN MDD AND HC GROUPS||2 DAYS|||||||
1315648|NCT02415166|Other Pre-specified|IL-6 AND TNF PRODUCTION BY STIMULATED AND UNSTIMULATED MONOCYTE CELLS||2 DAYS|Data not analyzed||||||
1315649|NCT02415166|Secondary|THE INFLUENZA VIRUS-INDUCED PROLIFERATION OF CD4+ MEMORY T-CELLS|Data not collected.|ONE MONTH|Unmedicated participants with major depressive disorder. Data were not collected.||||||
1315650|NCT02415166|Primary|THE TITER OF INFLUENZA ANTIBODIES|"Outcome data were not collected.~This was a failed study as all participants, including those who were putatively vaccine-naive had antibodies to influenza at baseline and therefore the original hypothesis could not be tested. The study was terminated."|ONE MONTH|Unmedicated outpatients with major depressive disorder. Outcome data not collected.||||||
1315651|NCT02415127|Secondary|Change From Baseline to Week 26 in Total Friedreich Ataxia Rating Scale Score (FARStot)|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions are assessed. FARStot scores range from 0 (normal) to 125 (most impairment). A negative change from baseline indicates improvement.|Baseline, Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and FARStot data at Baseline and Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||units on a scale||Standard Deviation|Mean
1315652|NCT02415127|Secondary|Number of FARS-mNeuro Responders and Non-Responders at Week 26|A participant was considered a responder if they had an improvement (decrease) of at least 3 points from Baseline at Week 26 for the FARS-mNeuro score. The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment).|Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and data at Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||Participants|||Count of Participants
1315653|NCT02415127|Secondary|Change From Baseline at Week 26 in Timed 25-Foot Walk (T25FW)|The T25FW is a quantitative measure of lower extremity function. Participants are directed to 1 end of a clearly marked 25-foot course and instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance, and the score for the test is the average of the 2 walks (after reciprocal transformation). Participants may use assistive devices when performing this task, with the same assistive device used at each assessment. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro), and T25FW data at Baseline and Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||1/seconds||Standard Deviation|Mean
1315654|NCT02415127|Secondary|Change From Baseline to Week 26 in Activities of Daily Living (ADL) Score|Participants and/or their caregivers rated 9 areas of daily living skills (speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function) on a 5-point scale (0=normal, 4=greatest loss of function) with allowable increments of 0.5 if the participant or caregiver strongly felt that a task falls between 2 scores. ADL scores can range from 0 (normal) to 36 (greatest loss of function). A negative change from baseline indicates improvement.|Baseline, Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and ADL data at Baseline and Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||units on a scale||Standard Deviation|Mean
1315655|NCT02415127|Primary|Change From Baseline to Week 26 in the Friedreich’s Ataxia Rating Scale (FARS)-mNeuro Score|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment). A negative change from baseline is an improvement.|Baseline, Week 26|Intent-to-Treat (ITT) Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and at Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||units on a scale||Standard Deviation|Mean
1315688|NCT02413294|Secondary|Self-Reported Sleep Diary: Time at Which Participants Wake up|Wake time represents the moment in time at which participants awaken. Time between actual hours is calculated on a decimal basis so an additional 6 minutes = .1. so that 7.5 represents 7:30 a.m. and 7.8 represents 7:48 a.m.|daily for 4 weeks- baseline and intervention period to be compared||||hour (military time)||Standard Deviation|Mean
1315656|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
1315657|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
1315658|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
1315659|NCT02414828|Primary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Maximum number of subjects with deterioration >15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)|182 Days|Subjects who were evaluated.|||participants|||Number
1315660|NCT02414828|Primary|Forced Vital Capacity (FVC)|Maximum number of subjects with deterioration >10% from baseline, at any time point, in forced vital capacity (FVC)|182 days|Subjects who were evaluated.|||participants|||Number
1315661|NCT02414828|Primary|Forced Expiratory Volume in One Second (FEV1)|Maximum number of subjects with deterioration >10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)|182 days|Subjects who were evaluated.|||participants|||Number
1315662|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
1315663|NCT02414828|Primary|Number of Participants With Solicited and Unsolicited AEs|All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.|182 days||||participants|||Number
1315664|NCT02414204|Secondary|Change in Blood Flow With Vein and Artery Diameters Increased at 6 Weeks||6 weeks||||Participants|||Count of Participants
1315665|NCT02414204|Primary|Change in Baseline and 2 Week FMD/VP Measurements||2 weeks||||Change in FMD%||Standard Error|Mean
1315666|NCT02414152|Primary|Response to Anakinra in Corticosteroid Resistant Patients With SSNHL|Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.|120 days|Zero subjects were analyzed because both enrolled subjects were withdrawn after receiving 56 days of anakinra because no hearing improvement was noted. They did not complete the entire study.||||||
1315667|NCT02413918|Primary|Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores|"The Bipolar Inventory of Symptoms Scale is a reliable and valid measure which assesses Depression and Mania symptoms of bipolar disorder. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows:~0 Not at all~Slight~Mild~Moderate~Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period.~For Depression: Items 1-21 items of the assessment are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the depression.~For Mania: Items 22-42 are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the mania. The mean is calculated from the change in score between baseline and week 20."|Baseline and 20 weeks|Subjects who are currently treated with mood stabilizers (Lithium, Divalproex or Lamotrigine), with a diagnosis of Bipolar Disorder I or II.|||percentage change in score on BISS scale|||Number
1315668|NCT02413879|Secondary|Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)|Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge|1 day (end of the procedure and removal of the investigational device)|Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.|||% of participants with contamination|||Number
1315669|NCT02413879|Primary|Safety (Serious Adverse Events Directly Attributable to the Device)|Incidence of Serious Adverse Events directly attributable to the device|30 days|All subjects within the Treatment arm were analyzed (Intention-to-treat).|||Participants|||Count of Participants
1315670|NCT02413879|Primary|Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)|Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge|1 day (end of the procedure and removal of the investigational device)|Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.|||% of participants with contamination|||Number
1315755|NCT02411539|Secondary|VRC01 Antibody Level Relative to Infusion Timing|Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up - aligning the timing of PK samples/results to the respective VRC01 infusions for each Arm|Measured immediately after first infusion (and 1, 2, and 3 weeks after), and immediately after second infusion (and 1, 2, 3, 6 and 9 weeks after)|Analysis of all participants with available results.|||ug/mL||Inter-Quartile Range|Median
1315671|NCT02413593|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
1315672|NCT02413593|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1315673|NCT02413593|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1315674|NCT02413593|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1315675|NCT02413593|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1315676|NCT02413593|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1315677|NCT02413489|Secondary|Time to Response|Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR) is first documented.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable participant was reported.|||Months|||Number
1315678|NCT02413489|Secondary|Overall Survival (OS)|Overall survival was defined as the duration from the date of the first daratumumab dose to the date of death.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab.|||Months||95% Confidence Interval|Median
1315679|NCT02413489|Secondary|Progression Free Survival (PFS)|PFS was defined as the duration from the date of the first daratumumab dose to the date of progression or death, whichever comes first.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab.|||Months||95% Confidence Interval|Median
1315680|NCT02413489|Secondary|Duration of Response|Duration of response was the duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD). PD is defined as any new lesion >1.5 centimeter (cm) in any axis or greater than or equal to (>=) 50% increase in previously involved sites.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable participant was reported.|||Months|||Number
1315681|NCT02413489|Primary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), or Magnetic resonance imaging (MRI) scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.|After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years)|The analysis population was all participants that were treated with daratumumab.|||Percentage of participants||95% Confidence Interval|Number
1315682|NCT02413346|Primary|Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. A TEAE is an AE that occurs after the first dose of study drug.|Up to 40 Weeks|Safety Population included all participants among the screened population who were exposed to study treatment (sarecycline) in either the double-blind lead-in study or this open-label extension study.|||participants|||Number
1315683|NCT02413333|Secondary|Mean Osmolality in Lens Cases at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations|||milliosmoles/kg (mOsm/kg)|Participants|Standard Deviation|Mean
1315684|NCT02413333|Primary|Mean Residual Peroxide at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations|||parts per million (ppm)|Participants|Standard Deviation|Mean
1315685|NCT02413294|Secondary|Self-Reported Sleep Diary: Sleep Duration|nightly mean of length of sleep measured in minutes|daily for 4 weeks- baseline and intervention period to be compared||||Minutes asleep||Standard Deviation|Mean
1315686|NCT02413294|Secondary|Self-Reported Sleep Diary: Night Awakenings|mean number of night awakenings per person per night as reported in sleep diaries|daily for 4 weeks- baseline and intervention period to be compared||||Number of night awakenings||Standard Deviation|Mean
1315687|NCT02413294|Secondary|Self-Reported Sleep Diary: Sleep Quality|sleep quality is a participants' mean self-report for each of the two week periods: baseline and intervention. Sleep quality is reported for each night on a scale of 0 (very poor) to 4 (very good).|daily for 4 weeks- baseline and intervention period to be compared||||units on a scale||Standard Deviation|Mean
1315689|NCT02413294|Secondary|Self-Reported Sleep Diary: Time at Which Participants go to Bed|Bed time represents the moment in time at which participants went to bed, measured on a revised clock where 6pm = 18, Midnight = 24 and 6am =30. Time between actual hours is calculated on a decimal basis, so an additional 6 minutes = .1. This revised clock is necessary in order to make means work properly in the nighttime hours. Otherwise, averaging between a 10pm bedtime and a 2am bedtime would give the impossible, inaccurate mean of being in the daytime between those two numbers.|daily for 4 weeks- baseline and intervention period to be compared||||hour (military time)||Standard Deviation|Mean
1315690|NCT02413294|Secondary|Fitbit Sleep Data: Sleep Efficiency|Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).|daily for 4 weeks- baseline and intervention period||||percentage of time in bed spent asleep||Standard Deviation|Mean
1315691|NCT02413294|Secondary|Fitbit Sleep Data: Night Awakenings|mean nightly awakenings for each of the two week periods: baseline and intervention. Similar to the actigraph the Fitbit counts awakenings through an accelerometer which measures motion.|daily for 4 weeks- baseline and intervention period||||count of night awakenings||Standard Deviation|Mean
1315692|NCT02413294|Secondary|Fitbit Sleep Data: Sleep Duration|mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention|daily for 4 weeks- baseline and intervention period||||Minutes asleep||Standard Deviation|Mean
1315693|NCT02413294|Secondary|Actigraph: Efficiency|Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100). The mean for each of the two-week periods: baseline and intervention, is calculated.|daily for 4 weeks- baseline and intervention period||||percentage of time in bed spent asleep||Standard Deviation|Mean
1315694|NCT02413294|Secondary|Actigraph: Number of Awakenings|Actigraphy counts awakenings by using an accelerometer to assess motion during the night. The number of awakenings is the mean nightly number of awakenings during each of the two-week periods: baseline and intervention.|daily for 4 weeks- baseline and intervention period||||count of awakenings||Standard Deviation|Mean
1315695|NCT02413294|Secondary|Actigraph Sleep Data: Minutes Asleep|mean nightly sleep duration for each of the two-week periods: baseline and intervention|daily for 4 weeks- baseline and intervention period||||minutes||Standard Deviation|Mean
1315696|NCT02413294|Primary|Morningness-Eveningness Questionnaire|The morningness- eveningness categories represent the time of day when a person is at their peak alertness.|two weeks after introduction of intervention||||Participants|||Count of Participants
1315697|NCT02413294|Primary|Insomnia Severity Index Sum Scores|The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.|two weeks after introduction of intervention||||units on a scale||Standard Deviation|Mean
1315698|NCT02413294|Primary|Patient Health Questionnaire-9 Depression Scale|The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.|two weeks after introduction of intervention||||units on a scale||Standard Deviation|Mean
1315699|NCT02413294|Primary|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.|two weeks after introduction of intervention||||units on a scale||Standard Deviation|Mean
1315700|NCT02413203|Secondary|Urinary Lipid Metabolites: TxB2 Metabolite (Tx-M)|Effect of celecoxib on systemic TxB2 was assessed by comparing urine Tx-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
1315701|NCT02413203|Secondary|Urinary Lipid Metabolites: PGI2 Metabolite (PGI-M)|Effect of celecoxib on systemic PGI2 was assessed by comparing urine PGI-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
1315702|NCT02413203|Secondary|Celecoxib Plasma Concentration|Celecoxib plasma concentration will be measured in drug-treated and placebo groups by UPLC-MS/MS, and will be expressed as amount of the drug per volume of plasma (ng/ml). At Tmax of 3 hours after a single oral dose of celecoxib of 200 mg, drug plasma concentration should correspond to the maximum plasma concentration or Cmax.|A single visit of around 4 hours||||ng/ml||Standard Deviation|Mean
1315703|NCT02413203|Secondary|Urinary Lipid Metabolites: PGE2 Metabolite (PGE-M)|Effect of celecoxib on systemic PGE2 was assessed by comparing urine PGE-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer’s own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
1315704|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: 15-Hydroxyeicosatetraenoic Acid (15-HETE)|15-HETE in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma 15-HETE was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents 15-HETE concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
1315705|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Thromboxane B2 (TxB2)|TxB2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma TxB2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents TxB2 concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
1316378|NCT02393209|Secondary|AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Phase 1b for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
1315706|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Prostaglandin F2a (PGF2a)|PGF2a in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGF2a was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGF2a concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
1315707|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Prostaglandin E2 (PGE2)|PGE2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGE2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject’s pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGE2 concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
1315708|NCT02413034|Primary|Sonication Cultures|Number of positive Sonication cultures (7)|14 days||||cultures|||Number
1315709|NCT02413034|Primary|Positive Cultures|Number of positive Tissue Cultures (7)|14 days||||cultures|||Number
1315710|NCT02412657|Secondary|Patients Overall Satisfaction|categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others|48 hours|||||||
1315711|NCT02412657|Secondary|Sleep Disturbance|Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)|24 hours and 48 hours|||||||
1315712|NCT02412657|Secondary|Residual Motor Block|Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)|24 hours and 48 hours|||||||
1315713|NCT02412657|Secondary|Pain Scores|On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)|every 6 hours during the first 48 hours after surgery|||||||
1315714|NCT02412657|Secondary|Total Opioid Consumption (mg)||48 hours after surgery||2017-12-31|12/2017||||
1315715|NCT02412657|Primary|Duration of Analgesia|Defined as the time between the performance of the block and the first analgesic request|48 hours after surgery||||hours||Inter-Quartile Range|Median
1315716|NCT02412501|Secondary|Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure||12 Months||||Participants|||Count of Participants
1315717|NCT02412501|Secondary|Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure||12 Months||||Participants|||Count of Participants
1315718|NCT02412501|Secondary|Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure||24 Months||2019-02-28|02/2019||||
1315719|NCT02412501|Secondary|Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure||12Months||||Participants|||Count of Participants
1315720|NCT02412501|Secondary|Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure|TVMI defined as Q Wave or non-Q Wave MI|12 Months||||Participants|||Count of Participants
1315721|NCT02412501|Secondary|Number of Participants With Cardiac Death at 12 Months Post Procedure||12 Months||||Participants|||Count of Participants
1315722|NCT02412501|Primary|Number of Participants With Target Lesion Failure at 12 Months Post-Procedure|Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.|12 Months||||Participants|||Count of Participants
1315723|NCT02411929|Secondary|Number of Participants Discontinuing Study Drug Due to Adverse Events (Periods 1 and 2)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 16 days|The Safety Population included all participants who received at least one dose of study drug.|||Participants|||Number
1315724|NCT02411929|Secondary|Number of Participants Who Experienced an Adverse Event (Periods 1 and 2)|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 33 days|The Safety Population included all participants who received at least one dose of study drug.|||Participants|||Number
1315725|NCT02411929|Secondary|Pharmacokinetic Parameter: Fraction Absorbed (Fa, Radioactivity in Urine) (Periods 1 and 2) (Dose Normalized)|Fraction absorbed is the fraction of the total ertugliflozin dose absorbed, regardless of the fate of that dose after absorption (i.e., metabolism, degradation, etc). Fraction Absorbed was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time zero to the time of last measurable concentration) following oral and IV administration of 14^C-ertugliflozin. Fraction of 14^C dose recovered in urine = 14^C total in urine in dpm/14^C total in dose in dpm|Part 1: pre- IV dose, 0-11 and 11-23 hrs. post IV dose, and 23 – 47, 47 – 71 and 71 – 95 hrs. until Day 5; Part 2: predose, 0-12 and 12-24 hrs. post dose, and then 24-hour intervals until Day 5|The estimated Fa Population included only the 6 participants with complete urine data for both treatments.|||Fraction of 14^C dose recovered in urine||Geometric Coefficient of Variation|Geometric Mean
1315732|NCT02411929|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1) (Dose Normalized to 1 mg)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1329601|NCT02107014|Primary|Change in LIF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1315726|NCT02411929|Secondary|Pharmacokinetic Parameter: Steady-State Volume of Distribution (Vss) Following IV Infusion - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Steady-State Volume of Distribution is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1315727|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Volume of Distribution (Vz/F) Following Oral Administration - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug intravneous arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1315728|NCT02411929|Secondary|Pharmacokinetic Parameter: Systemic IV Total Plasma Clearance (CL) - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Systemic clearance is a calculation of the rate at which a drug is removed from plasma via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||mL/min.||Geometric Coefficient of Variation|Geometric Mean
1315729|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Oral Total Plasma Clearance (CL/F) - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Apparent clearance is a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug IV arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||mL/min.||Geometric Coefficient of Variation|Geometric Mean
1315730|NCT02411929|Secondary|Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Hours||Standard Deviation|Mean
1315731|NCT02411929|Secondary|Pharmacokinetic Parameter: Time for Cmax (Tmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. The confidence intervals displayed are minimums to maximums.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Hours||Full Range|Median
1315752|NCT02411578|Secondary|CGM Maximum Glucose, Event Level|Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
1315733|NCT02411929|Secondary|Pharmacokinetic Parameter: (AUC Inf) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the dose. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1315734|NCT02411929|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV (Period 1) (Dose Not Normalized to 1 mg)|AUC0-last is a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1315735|NCT02411929|Primary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) (Dose Normalized to 1 mg) and Absolute Oral Bioavailability (F) (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the drug dose. An absolute bioavailability provides information on the amount of a drug reaching the systemic circulation and can be determined by comparing the plasma concentration-time-curves (area under the curve) of a compound after oral application of that compound to that after intravenous application of the same compound.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The pharmacokinetic (PK) Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||AUCinf(dn), ng•hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1315736|NCT02411747|Primary|Global Rating Scale|The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale. A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures. GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure. Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25. At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.|Two to four weeks after day of simulation training|Two cystoscopies performed on patients by each participant|||units on a scale|Participants|Standard Deviation|Mean
1315737|NCT02411578|Post-Hoc|Clinical Grading - Initial Treatment Correct|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|"This analysis included all hypoglycemic events in which the initial treatment and dose were correct, irrespective of the timing of the BG measurements.~8 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period and 4 during the glucose tabs period."|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
1315738|NCT02411578|Post-Hoc|Clinical Grading - Initial and 15-min Treatment Correct|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|"Analysis was limited to hypoglycemic events where Initial and 15-min Treatment were correct.~4 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period."|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
1315753|NCT02411578|Secondary|Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level|Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
1315739|NCT02411578|Post-Hoc|Clinical Grading - Limited to Events in Primary Analysis|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|Analysis was limited to hypoglycemic events included in the primary analysis. 3 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period.|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
1315740|NCT02411578|Secondary|CGM Coefficient of Variation|Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||percentage coefficient of variation||Inter-Quartile Range|Median
1315741|NCT02411578|Secondary|CGM Time Below 70|Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||percentage of time||Inter-Quartile Range|Median
1315742|NCT02411578|Secondary|CGM Time in Range|Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||percentage of time||Inter-Quartile Range|Median
1315743|NCT02411578|Secondary|CGM Mean Glucose|Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||mg/dL||Inter-Quartile Range|Median
1315744|NCT02411578|Secondary|CGM Time Below 70 mg/dL|Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
1315745|NCT02411578|Secondary|CGM Time in Range, Event Level|Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
1315746|NCT02411578|Secondary|CGM Mean Glucose, Event Level|Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
1315747|NCT02411578|Secondary|CGM Maximum Glucose, Event Level|Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
1315748|NCT02411578|Secondary|CGM Minimum Glucose, Event Level|Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
1315749|NCT02411578|Secondary|CGM Time Below 70 mg/dL, Event Level|Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
1315750|NCT02411578|Secondary|CGM Time in Range, Event Level|Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
1315751|NCT02411578|Secondary|CGM Mean Glucose, Event Level|Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
1315756|NCT02411539|Secondary|Plasma Levels of High-sensitivity C-reactive Protein (hsCRP)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315757|NCT02411539|Secondary|Plasma Levels of Tumor Necrosis Factor Alpha (TNFα)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315758|NCT02411539|Secondary|Plasma Levels of Human Soluble Tumor Necrosis Factor Alpha-receptor (sTNFαR)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315759|NCT02411539|Secondary|Plasma Levels of Interleukin-6 (IL-6)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315760|NCT02411539|Secondary|Plasma Levels of sCD14|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315761|NCT02411539|Secondary|Plasma Levels of sCD163|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315762|NCT02411539|Secondary|Levels of NK Cell Activation|"% NK cells expressing CD69 or CD95~Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315763|NCT02411539|Secondary|Levels of T-cell Activation|"% CD4+ and CD8+ T-cells co-expressing human leukocyte antigen (HLA)-DR and CD38~Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
1315764|NCT02411539|Secondary|Detectability of Antibody to VRC01 as Measured in Serum|Assess the detectability of antibody to VRC01 in samples collected during study follow-up. Intended to be result from specimen at week 30 time point. Due to specimen availability, four participants in Arm A had results from specimens from the week 18 time point. Counts provided are number of participants with detectable anti-VRC01 antibody result.|Measured at week 30|All participants with results for anti-VRC01 antibody. Two participants did not have results (one from each arm) due to being lost to follow up.|||Participants|||Count of Participants
1315765|NCT02411539|Secondary|VRC01 Antibody Level|"Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up~Specific specimens and time points were targeted for testing based on Arm. Samples for Arm A were not tested for the Week 6 and Week 9 post-infusion time points. Samples for Arm B were not tested for the Week 0 and Week 3 post-infusion time points."|Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30|Analysis of all participants with available results.|||ug/mL||Inter-Quartile Range|Median
1315766|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield|As part of the total virus recovery assay, results for %tCD4 yield are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available %tCD4 yield results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
1315767|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
1315768|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor|As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
1315769|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor|As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
1315770|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry and week 6|Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay|||fold change||Inter-Quartile Range|Median
1315771|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA|As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
1315772|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA|As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
1315773|NCT02411539|Secondary|Total/Inducible Virus Recovery - Percentage of Total CD4 Yield|As part of the total virus recovery assay, results for %tCD4 yield are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available %tCD4 yield results from virus recovery assay|||percentage of Total CD4 Yield||Inter-Quartile Range|Median
1315774|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay|||ratio||Inter-Quartile Range|Median
1315775|NCT02411539|Secondary|Total/Inducible Virus Recovery - Unstimulated Cell Fluor|As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available unstimulated cell fluor results from virus recovery assay|||million light units||Inter-Quartile Range|Median
1315776|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated Cell Fluor|As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated cell fluor results from virus recovery assay|||million light units||Inter-Quartile Range|Median
1315777|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay|||ratio||Inter-Quartile Range|Median
1315778|NCT02411539|Secondary|Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA|As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated|Measured at pre-entry, week 6 and week 12|Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay|||log10 copies/mL||Inter-Quartile Range|Median
1315779|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated HIV-1 RNA|As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay|||log10 copies/mL||Inter-Quartile Range|Median
1315780|NCT02411539|Secondary|CD8+ T-cell Counts|Baseline measure represents the average of screening and entry results|Measured at screening, entry and weeks 6, 12, 18 and 30|Analysis of all participants with available CD8+ results|||cells/mm^3||Inter-Quartile Range|Median
1315781|NCT02411539|Secondary|CD4+ T-cell Counts|Baseline measure represents the average of screening and entry results|Measured at screening, entry and weeks 6, 12, 18 and 30|Analysis of all participants with available CD4+ results|||cells/mm^3||Inter-Quartile Range|Median
1315782|NCT02411539|Secondary|Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit|"The analysis of HIV-1 RNA SCA assessed the number of participants below the assay lower limit (1 copy/mL) at each measurement week. Specific specimens and time points were targeted based on Arm. Samples were not tested for Arm A at the Week 7 and Week 10 time points. Samples were not tested for Arm B at the Week 1 and Week 4 time points.~Testing of specimens at weeks 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available SCA results|||Participants|||Count of Participants
1315783|NCT02411539|Secondary|Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 RNA/DNA ratio|||log10 ratio||Inter-Quartile Range|Median
1315784|NCT02411539|Secondary|Cell-associated HIV-1 DNA in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 DNA results|||log10 copies/million CD4||Inter-Quartile Range|Median
1315785|NCT02411539|Secondary|Cell-associated HIV-1 RNA in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 RNA results|||log10 copies/million CD4||Inter-Quartile Range|Median
1315786|NCT02411539|Secondary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms|Summary of within-participant change across treatment arms from the pre-VRC01 time point to the post-VRC01 time point. For Arm A, the pre-VRC01 time point used was the baseline measure (geometric average of screening and entry results) and the post-VRC01 time point was the week 6 measure. For Arm B, the pre-VRC01 time point used was the week 6 measure and the post-VRC01 time point was the week 12 measure. Change in CA-RNA/DNA ratio was calculated on the log10 scale.|Screening, entry and weeks 6 and 12|Analysis of all participants with available pre- and post-VRC01 cell-associated RNA/DNA ratio results available. Participants from Arm A must have had results at entry and week 6. Participants from Arm B must have had results from week 6 and week 12.|||log10 ratio||Inter-Quartile Range|Median
1315787|NCT02411539|Secondary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF)|Change from baseline (geometric average of screening and entry results) to week 6 in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, using a last value carried forward approach if week 6 cell-associated HIV-1 RNA/DNA ratio was missing. In the event that the week 6 value was missing, the week 3 value was carried forward to be used. This comparison is the change from the average of screening and entry results to the week 6 value (if available), and if week 6 result was not available, the week 3 value was used instead of the week 6 value.|Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary)|Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, carrying last available result forward if missing at week 6|||log10 ratio||Inter-Quartile Range|Median
1315788|NCT02411539|Secondary|Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment|Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment|Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)|All participants who received at least one infusion of study treatment|||Participants|||Count of Participants
1315789|NCT02411539|Primary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells|Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells|Screening, entry and week 6|Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells. All participants received at least one dose of the randomized treatment assigned. No participants received the incorrect treatment.|||log10 ratio||Inter-Quartile Range|Median
1315790|NCT02411539|Primary|Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE)|"Refer to detailed description in the protocol section.~Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed."|Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)|Includes all available follow-up for all participants|||Participants|||Count of Participants
1315791|NCT02411461|Primary|Intelligence Quotient|Intelligence quotient as measured by Kaufman Brief Intelligence Test, 2nd Edition. This scale yields standard scores where the mean is 100 and one standard deviation is 15. Higher scores indicate better function.|one day||||units on a scale||Standard Deviation|Mean
1315792|NCT02411292|Primary|Number of Participants With Bleeding Events|Bleeding events requiring alteration in the course of care within 90 days of surgery|90 days|Bleeding events are reported for the 94 who were not discharged prior to the third Enoxaparin dose. Because two bleeding events occurred prior to the drawing of labs, they cannot be classified into low vs. in-range/high enoxaparin levels. Because of this, reporting on bleeding events is reported across the whole study population and not by arm.|||Participants|||Count of Participants
1315793|NCT02411292|Primary|Number of Participants With Venous Thromboembolism Events|Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery|90 days|Patients with out-of-range levels or missing levels were dropped from relevant analyses. Of the 89 participants who completed the study, 88 had peak steady-state anti-factor Xa levels to be analyzed.|||Participants|||Count of Participants
1315794|NCT02411201|Secondary|MRI Lesion Visualization at Subject Level|"Lesion visualization was assessed on up to five most representative lesions per subject based on scoring of 3 co-endpoints:~border delineation (based on a 3-point scale where 1=none; 2=moderate and 3=clear and complete)~internal morphology (based on a 3-point scale where 1=poorly visible; 2=moderately visible and 3=sufficiently visible)~contrast enhancement (based on a 3-point scale where 1=none; 2=weak and 3=clear and bright)~For each co-endpoint, a sum of scores was calculated at subject level as follows: sum of scores = score of the lesion 1 (+ score of the lesion 2 + score of the lesion 3 + score of the lesion 4 + score of the lesion 5, when applicable)"|Pre-injection and post-injection (estimated between 5 and 20 minutes after injection)|Lesion visualization was evaluated in 28 subjects who underwent contrast-enhanced MRI for central nervous system indication.|||units on a scale||Standard Deviation|Mean
1315829|NCT02410343|Secondary|Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint|"One measure of changes in replacement hormones.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||MIU/L||Standard Deviation|Mean
1315795|NCT02411201|Secondary|Simulated Plasma Concentration of DOTAREM|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method.|at 10 and 20 min post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||µmol/L||Full Range|Median
1315796|NCT02411201|Primary|Volume of Distribution of DOTAREM at Steady State|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Volume of distribution at steady state was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||L/kg||Full Range|Mean
1315797|NCT02411201|Primary|Total Clearance of DOTAREM From Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Total clearance was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||L/hour per kg||Full Range|Mean
1315798|NCT02411201|Primary|Terminal Elimination Half-life of DOTAREM From Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Terminal elimination half-life was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||hour||Full Range|Mean
1315799|NCT02411201|Primary|Rate Constant of the Terminal Phase of DOTAREM|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Rate constant of the terminal phase was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||hour-1||Full Range|Median
1315800|NCT02411201|Primary|Area Under the Curve of DOTAREM in Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Area under the curve was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||hour.µmol/L||Full Range|Median
1315801|NCT02411110|Primary|Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up|The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis.|Baseline (Days -7 to 0) to Treatment 1 Week 4|Modified Intent-to-Treat (mITT) Analysis Population included all participants who were randomized and received Treatment 1.|||score on a scale||90% Confidence Interval|Least Squares Mean
1315802|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up|follow-up youth self-rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child self-rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
1315803|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment|posttreatment youth self-rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child self-rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
1315804|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up|follow-up parent rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
1315805|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment|posttreatment parent rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
1315806|NCT02410967|Primary|Pediatric Anxiety Rating Scale at Follow-up|follow-up clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.|7 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
1316093|NCT02404103|Primary|Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide|the most used outcome in respiratory studies|Before and after treatment at baseline and six week followup|Those subjects that completed the study protocol.|||% of predicted||Standard Deviation|Mean
1315807|NCT02410967|Primary|Pediatric Anxiety Rating Scale at Posttreatment|posttreatment clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.|7 days|Intent to treat|||units on a scale||Standard Deviation|Mean
1315808|NCT02410824|Secondary|Overall Satisfaction|Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1315809|NCT02410824|Secondary|Dryness|Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.|1 Week||||units on a scale||Standard Deviation|Mean
1315810|NCT02410824|Primary|Lens Fit Acceptance|Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315811|NCT02410824|Primary|Lens Durability|Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).|1 Week||||Lens tear or nick|Lenses||Number
1315812|NCT02410824|Primary|Conjunctival Staining|"Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent~N - Nasal, T - Temporal, S - Superior, I - Inferior"|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1315813|NCT02410824|Primary|Corneal Staining, Extent|Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1315814|NCT02410824|Primary|Corneal Staining, Type|Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1315815|NCT02410824|Primary|Lens Surface - Deposits|Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315816|NCT02410824|Primary|Lens Surface - Wettability|Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315817|NCT02410824|Primary|Low Visual Acuity|Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.|Baseline and 1 Week||||LogMAR||Standard Deviation|Mean
1315818|NCT02410824|Primary|High Visual Acuity|High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.|Baseline and 1 Week||||LogMAR||Standard Deviation|Mean
1315819|NCT02410824|Primary|Vision|Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315820|NCT02410824|Primary|Handling|Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315821|NCT02410824|Primary|Comfort|Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315822|NCT02410343|Secondary|Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints|Weeks 4 and 8 serum samples obtained 2 days after TV1106 administration. Weeks 12 and 24 serum samples obtained 7 days after TV1106 administration. Week 16 serum samples obtained 1 day after TV1106 administration.|Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24|Safety population of participants treated with TV1106|||ng/mL||Full Range|Median
1315823|NCT02410343|Secondary|Local Tolerability Assessed by Injection Site Reactions|Participants reporting at least one injection site reaction.|Day 1 up to Week 24|Safety population|||Participants|||Count of Participants
1315824|NCT02410343|Secondary|Insulin at Baseline and Endpoint|"One measure of glucose homeostasis.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||PMOL/L||Standard Deviation|Mean
1315825|NCT02410343|Secondary|Fasting Blood Glucose at Baseline and Endpoint|"One measure of glucose homeostasis.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||MMOL/L||Standard Deviation|Mean
1315826|NCT02410343|Secondary|Glycated Hemoglobin (HbA1c) at Baseline and Endpoint|"One measure of glucose homeostasis.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||percentage of total hemoglobin||Standard Deviation|Mean
1315827|NCT02410343|Secondary|Triiodothyronine (Total T3) at Baseline and Endpoint|"One measure of changes in replacement hormones.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||NMOL/L||Standard Deviation|Mean
1315828|NCT02410343|Secondary|Free Thyroxin (Free T4) at Baseline and Endpoint|"One measure of changes in replacement hormones.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||PMOL/L||Standard Deviation|Mean
1320512|NCT02288273|Secondary|Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)||Day 22 and Day 64||||mg/dL||Standard Error|Least Squares Mean
1315830|NCT02410343|Secondary|Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings|"Shifts represented as baseline - endpoint value (last observed post-baseline value).~Abnormal NCS indicates an abnormal but not clinically significant finding. Abnormal CS indicates an abnormal and clinically significant finding."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population|||Participants|||Count of Participants
1315831|NCT02410343|Secondary|Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results|"Parameters with potentially clinically significant abnormal test results include~Serum chemistry: blood urea nitrogen, creatinine and bilirubin~Hematology: leukocytes, hemoglobin, hematocrit, platelets and neutrophils~Urinalysis: none Significance criteria are listed below with the test."|Day 1 up to 24 Weeks|Safety population|||Participants|||Count of Participants
1315832|NCT02410343|Secondary|Participants With Adverse Events During the Core Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to 24 Weeks|Safety population|||Participants|||Count of Participants
1315833|NCT02410343|Secondary|Scored Analysis of Quality of Life Assessment of GH Deficiency in Adults (QoL-AGHDA) at Baseline, Week 24 and Endpoint in Core Period|"The AGHDA instrument is comprised of 25 questions, with yes or no answers. To each of the 25 questions comprising QOL AGHDA, a score of 1 was assigned if the answer was affirmative and 0 if the answer was negative. Data reported is the total score across the 25 questions for a total range of 0-25 with higher scores representing a poorer quality of life. The outcome as defined in the protocol was the within-patient change from baseline to week 24.~Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24."|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week 24)|ITT|||units on a scale||Standard Deviation|Mean
1315834|NCT02410343|Secondary|Insulin-Like Growth Factor 1 Standard Deviation Score (IGF-I SDS) at Baseline, Week 24 and Endpoint in Core Period|"IGF-I SDS, as reported by the central laboratory, was a key secondary variable. The week 24 value is a trough value as it was taken 7 days after the last TV-1106 or placebo injection.~The outcome as defined in the protocol was the within-patient change from baseline to week 24. Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24."|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week 24)|ITT|||standard deviation score||Standard Deviation|Mean
1315835|NCT02410343|Secondary|Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period|"Trunk fat (kg) was assessed based on DXA results. Trunk fat was defined as fat mass - (total arm fat + total leg fat + total head fat). The outcome as defined in the protocol was the within-patient change from baseline to week 24 in trunk fat.~Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24."|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week 24)|ITT|||kg||Standard Deviation|Mean
1315836|NCT02410343|Primary|Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period|The primary efficacy measure for the study was body fat mass (kg) measured by DXA imaging. The primary outcome as defined in the protocol was the change from baseline to week 24 in body fat mass. Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24.|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (post-baseline value prior to Week 24)|ITT|||kg||Standard Deviation|Mean
1315837|NCT02410291|Primary|Number of Participants Whom Had Proper Preparation After Education Intervention|patients will receive a questionnaire to assess their satisfaction of their appointment. CT scans will be assessed for compliance of preparation based on departmental guidelines and rescans required.|1 month (patients will be followed until their treatment is complete)||||participants|||Number
1315838|NCT02410278|Secondary|Percentage of Participants Who Experienced AEs Related to Flushing|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Flushing-related AEs included flushing and hot flush. Only events with an onset date on or after the date of first DMF dose (up to 27 days before Day 0) are presented. This includes events present before and subsequently worsened after the first dose of DMF.|Day of first DMF dose (up to 27 days before Day 0) to Week 10|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
1315839|NCT02410278|Secondary|Percentage of Participants Who Discontinued DMF Therapy Due to GI-Related Adverse Events (AEs) From Day 0 to Week 10|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Participants used an electronic diary to record GI-related events. GI-related AEs included diarrhea, nausea, upper abdominal pain, abdominal pain, and dyspepsia.|Day 0 to Week 10|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
1315840|NCT02410278|Secondary|Percentage of Participants Who Required GI Symptomatic Therapy During the Study|Symptomatic therapies were not permitted during the first 10 days after starting montelukast or placebo. From Day 10 onward, participants were allowed to use the following symptomatic therapies to treat DMF-related GI events: bismuth subsalicylate, simethicone, calcium carbonate, loperamide, proton-pump inhibitors and ondansetron.|Day 10 to Week 10|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
1315841|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 0 to 72 Hours From the Initiation of Randomized Study Treatment|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) at Day 1 to Day 3. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 is the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 3 (72 hours after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of both DMF treatment and study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period. One participant in the MITT-Montelukast arm did not provide post-baseline data.|||units on scale||Standard Deviation|Mean
1315842|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) between Day 1 and the specified time point. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 1 (1 Day after Day 0), Weeks 1 to 8 (1-8 weeks after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||unit on scale||Standard Deviation|Mean
1315843|NCT02410278|Secondary|Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Recovery was defined as a GSRS score less than or equal to the Day 0 score. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. Time to recovery was defined as the date of recovery minus the date of the last occurrence of the worst score.|Baseline (Day 0), Day 1 (1 Day after Day 0) to Week 8 (8 weeks after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||days||Inter-Quartile Range|Median
1315844|NCT02410278|Secondary|Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose.. Time to the first worsening was defined as the number of days from Day 1 to the first date with a worsened GSRS score. Censoring occurred at Day 10.|Baseline (Day 0), Day 1 (1 day after Day 0) to Day 10 (10 days after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||days||Inter-Quartile Range|Median
1315845|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 1 to Week 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) between Day 1 and Week 10. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 1 (1 day after Day 0), Week 10 (10 weeks after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||units on scale||Standard Deviation|Mean
1315846|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) at Day 1 to Day 10. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 1 (1 day after Day 0), Day 10 (10 days after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||units on a scale||Standard Deviation|Mean
1315847|NCT02410278|Primary|Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Worsening in severity was defined as a positive average change from baseline (Day 0) to Day 10 in the GSRS score. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. Average change is the sum of changes from baseline in GSRS score over the first 10 days divided by the total of days with a GSRS score.|Baseline (Day 0), Day 10 (10 days after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
1315848|NCT02410252|Secondary|Usability, Acceptability and Satisfaction|This will be assessed by questionnaires specifically designed for this study. We will be assessing ease of use, acceptability, connection and use problems like the device falling off the skin, usefulness of out-of-range temperature alerts and adverse reactions. We will also assess to see if the device helps to build caregiver self-efficacy skills in caring for the patient.|2 weeks|Caregivers of participants using the device.|||Participants|||Count of Participants
1315849|NCT02410252|Secondary|Care Giver Anxiety|The Generalized Anxiety Disorder, 7 item questionnaire was given to caregivers to see if using the device increased feelings of anxiety. This will be assessed using the GAD-7 questionnaire administered at enrollment and closeout|0 & 2 weeks|Caregivers of participants using the device.|||Participants|||Count of Participants
1315850|NCT02410252|Primary|Percent of Participants That Successfully Used the iThermonitor|This will be assessed by ability of the device to successfully capture, transmit and display the patient’s body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. “Time in the study” here is defined as the number of days the subject spends in the study which is expected to be two weeks.|Two Weeks|Caregivers of participants using the device|||% of participants|||Number
1315851|NCT02410213|Primary|Maximum Serum Concentration (Cmax)|Maximum observed serum concentration; obtained directly from the serum concentration-time profile.|prior to dosing and 1, 2, 6, 12, 48 and 72 hours post dosing|In Cohort 1, pharmacokinetic parameter values are excluded for one subject due to anomalous and consistently high concentrations, and for one subject due to missing concentration data at 1 and 2 hours post-dose.|||µg/mL||Standard Deviation|Mean
1315852|NCT02410200|Secondary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Up to Week 28|All participants who received at least 1 dose of BG00012.|||participants|||Number
1315853|NCT02410200|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||h*mcg/mL||Standard Deviation|Mean
1315854|NCT02410200|Secondary|Half-Life Lambda z||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||hours||Standard Deviation|Mean
1315855|NCT02410200|Secondary|Apparent Volume of Distribution (V/F)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||L||Standard Deviation|Mean
1315856|NCT02410200|Secondary|Apparent Clearance (CL/F)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||L/h||Standard Deviation|Mean
1315857|NCT02410200|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||hours||Standard Deviation|Mean
1315858|NCT02410200|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||ng/mL||Standard Deviation|Mean
1315859|NCT02410200|Primary|Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment Period||Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24)|Primary Analysis Population: participants having new or newly enlarging T2 lesions during the Baseline period with a post-baseline assessment.|||lesions||Standard Deviation|Mean
1315860|NCT02409784|Primary|Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet||At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet||||µmol/100g/min||Standard Error|Mean
1315861|NCT02409784|Primary|Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet||At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet||||µmol/100g/min||Standard Error|Mean
1315862|NCT02409459|Secondary|Change in Iron Indices - Transferrin Saturation||Change from baseline in Iron Indices, Transferrin saturation, at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||percent of transferrin saturation||Standard Deviation|Mean
1315863|NCT02409459|Secondary|Change in Iron Indices, Serum Ferritin||Change from Baseline in Iron Indices, Serum ferritin at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||ug/L||Standard Deviation|Mean
1315864|NCT02409459|Secondary|Change in Fatigue Visual Numeric Scale|Scores range from 0 to 10, with the higher score indicating more fatigue.|Change from Baseline in Fatigue Visual Numeric Scale at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
1315865|NCT02409459|Secondary|Change in BPI, Pain Severity|The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0–10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Severity Score is calculated by adding the scores for the 4 pain severity questions and then dividing by 4 to give a severity score out of 10.|Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
1315866|NCT02409459|Secondary|Change in FIQR Score|The FIQR has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst' and all questions are framed in the context of the past 7 days. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three modified domain scores.|Change from Baseline in FIQR score at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
1315867|NCT02409459|Secondary|Change in BPI, Pain Interference|The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0–10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Interference Score is calculated by adding the scores for the 7 pain interference questions and then dividing by 7 to give a score out of 10.|Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
1315868|NCT02409459|Primary|Proportion of Patients With a ≥13 Point Improvement in FIQR Score|The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.|Day 42|The Safety population consisted of all subjects who received at least one dose of randomized treatment. The Efficacy Evaluable Population consisted of all subjects who received at least 1 dose of randomized treatment with at least 1 completed post treatment FIQR evaluation.|||Participants|||Count of Participants
1315869|NCT02408692|Secondary|Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel|Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel|Follicular phase of menstrual cycle||||ng/mL||Standard Deviation|Mean
1315870|NCT02408692|Primary|Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel|Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel|Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5||||ng/mL||Standard Deviation|Mean
1315871|NCT02408263|Secondary|Nausea|Nausea was assessed by patients’ self-report on their level of nausea on a 0-3 scale: 0=No nausea; 1=Mild nausea; 2=Moderate nausea; 3=Severe nausea.|Baseline, Postoperative day 1, Postoperative day 2||||units on a scale||Standard Deviation|Mean
1315872|NCT02408263|Primary|Skin Conductance Response|A skin conductance response is defined as a minimum followed by a maximum in conductance values micro Siemens (mS).|Baseline, Postoperative day 1, Postoperative day 2||||micro Siemens (mS)||Standard Deviation|Mean
1315873|NCT02408263|Primary|Pain|Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain)|Baseline, Postoperative day 1, Postoperative Day 2||||units on a scale||Standard Deviation|Mean
1315874|NCT02408068|Primary|Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using Tmax.|To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using Tmax.|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||hours||Standard Deviation|Median
1315875|NCT02408068|Primary|Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using AUC0-t|To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using area under the curve|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1320513|NCT02288273|Secondary|Change From Baseline (Day1) to Day 70 and Day 22 in FPG||Day 22/Day70||||mg/dL||Standard Error|Least Squares Mean
1315876|NCT02408068|Primary|Bioavailability of Chronocort® vs Hydrocortisone Tablets - Cmax|Evaluation of the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state by Cmax|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1315877|NCT02408068|Primary|Comparison of Fed and Fasted Chronocort Tmax|Comparison of Fed and Fasted Chronocort based on the time to achive the maximum concentration of serum cortisol|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||hours||Standard Deviation|Median
1315878|NCT02408068|Primary|Comparison of Fed and Fasted Chronocort AUC0-t|"Area under the curve from 0 to 24 hours for serum cortisol. Please note that the AUC0-t will be presented as a single figure (geometric mean) to represent exposure over time.~N.B., the sampling points for Hydrocortisone are as follows: 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h and 12h post-dose. However, the results for Hydrocortisone will not be incorporated into the analysis for this outcome measure."|24 hours (at 0h, then 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h, 13h, 14h, 15h, 16h, 18h, 20h, 22h and 24h post-dose.)|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1315879|NCT02408068|Primary|Chronocort Cmax|Comparison of fed and fasted Chronocort Cmax for serum cortisol.|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||nmol/L||Geometric Coefficient of Variation|Geometric Least Squares Mean
1315880|NCT02407704|Secondary|Neurocognitive Function (Neuropsychological Battery)|The battery evaluates several cognitive domains. The Wechsler Adult Intelligence Scale, 4th ed. Digit Span subtest assesses attention and working memory. The Repeatable Battery of Neuropsychological Status (RBANS) measures Immediate and Delayed Memory, Attention, Language Abilities, and Visuospatial Functioning. Total index scores range from 40-155. The California Verbal Learning Test, 2nd Ed. (CVLT) assesses non-contextual verbal learning and memory. Z-scores are calculated for each of the constructs assessed by the CVLT. Subtests from the Deli-Kaplan Executive Function System (D-KEFS) assess aspects of executive functioning, including set-shifting (Trail Making Test Conditions 4 and 5: scaled score ranging from 0-19) and inhibition (Color-Word Interference Test Condition 3: weighted scaled score ranging from 1-19). Given that standardized scores are calculated for each of the neuropsychological measures, higher scores always indicate better cognitive functioning.|Baseline and 12 weeks|"1 participant in the Venlafaxine XR Only (20-39 Years) group was excluded from analyses as he/she was non-compliant with the medication regimen. Another participant in the Venlafaxine XR Only (60-79 Years of Age) was excluded from analyses as he/she was unable to complete Week 12 testing due to physical limitations."|||units on a scale||Standard Deviation|Mean
1315881|NCT02407704|Secondary|Functional Magnetic Resonance Imaging (fMRI)|Brain imaging conducted with a 7 Tesla scanner. Of particular interest were changes in hippocampal volume, GABA, and glutamate. The changes regarding hippocampal volumes are reported below. This measurement is reported in mm^3, with higher numbers indicating higher levels of gray matter in the hippocampal region. Volume is combined between right and left hemispheres. GABA and glutamate are not reported. The method used to obtain the data was being piloted for this study, and due to methodological challenges, the data is not considered to be accurate and therefore cannot be analyzed/shared.|Baseline and 12 weeks|2 participants were excluded from analyses due to lack of usable data at both time points.|||mm^3||Standard Deviation|Mean
1315882|NCT02407704|Secondary|Cardiovascular Fitness (Submaximal VO2)|Cardiorespiratory fitness was measured via submaximal VO2 on a motorized treadmill while measuring oxygen utilization via Parvo Medics True one metabolic cart. The submaximal test followed a modified Balke protocol in which speed remained constant with the intensity being increased every two minutes via a raise of 2.0% of the incline. The speed was an agreed upon speed between participant and staff (between 2.0 and 4.0 mph). The submaximal VO2 was stopped when participant reached 85% of age predicted maximal heart rate (220 – age), rating of perceived exertion (RPE) equal to or greater than 15 for those who have blunted heart rate response due to beta block medication, or volitional termination by participant. Vital signs were monitored throughout the test and cool down period. Peak VO2 values for this cohort ranged from 14.04 to 36.48 ml/kg/min, with higher values correlated to higher fitness level.|Baseline and 12 weeks|"1 participant in the Venlafaxine XR Only (20-39 Years of Age) group was excluded from analyses as he/she was non-compliant with the medication regimen, discontinuing the medication at Week 8."|||ml/kg/min||Standard Deviation|Mean
1315883|NCT02407704|Secondary|Physical Activity (SenseWear Physical Activity-monitoring Armband)|This will be used to acquire objective information about physical activity. This armband is worn around the upper arm (left triceps) for 1 week and collects information about skin temperature, galvanic skin response, heat flux, and motion via a 3-axis accelerometer. This information is used in an algorithm to determine energy expenditure (EE). The device has a resolution of 1-minute indicating that we can acquire the above information on a minute-by-minute basis, which will allow us to determine both duration and intensity of activity during a normal week. Higher values indicate higher levels of activity.|Baseline and 12 weeks|1 participant in the Venlafaxine XR Only (20-39 Years of Age) group was excluded from analyses as he/she was non-compliant with the medication regimen, discontinuing the medication after Week 8.|||kcals||Standard Deviation|Mean
1315884|NCT02407704|Secondary|Genetic Biomarkers|Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.|Baseline and 12 weeks|Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.|||Participants|||Count of Participants
1315885|NCT02407704|Secondary|Inflammatory Biomarkers|Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.|Baseline and 12 weeks||||Participants|||Count of Participants
1316379|NCT02393209|Secondary|AUCtau: Area Under the Concentration Time Curve From Time 0 to the Next Dose in Phase 1b for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
1315886|NCT02407704|Primary|Number of Participants Experiencing Remission|Study completers will be classified as remitters vs. non-remitters. Remission will be defined as a MADRS score of 10 or less for at least two consecutive assessments. The MADRS will also be used to assess clinical response throughout the trial and to determine final medication dosage. At the end of week 6, those with a MADRS score greater than 10 will have the venlafaxine XR increased from 150 mg/d to a maximum of 300 mg/d.|Baseline, weekly for weeks 1 and 2, then biweekly for weeks 4-12|"1 participant in the Venlafaxine XR Only (20-39 Years of Age) group was excluded from analyses as he/she discontinued the medication after week 8."|||Participants|||Count of Participants
1315887|NCT02406937|Secondary|Body Mass Index (BMI)|BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2 (kilogram per square meter).|Baseline, Week 4, Week 8, Week 12||||kg/m^2||Standard Deviation|Mean
1315888|NCT02406937|Secondary|Sleeping Time|Questionnaire recorded by parents. Average sleeping time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12||||hours/day||Standard Deviation|Mean
1315889|NCT02406937|Secondary|Milk Feeding Quantity|Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.|Baseline, Week 4, Week 8, Week 12||||ml/day||Standard Deviation|Mean
1315890|NCT02406937|Secondary|Milk Regurgitation Frequency|Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.|Baseline, Week 4, Week 8, Week 12||||Times/day||Standard Deviation|Mean
1315891|NCT02406937|Secondary|Chest Circumference||Baseline, Day 28, Day 56, Day 84||||cm||Standard Deviation|Mean
1315892|NCT02406937|Secondary|Head Circumference||Baseline, Day 28, Day 56, Day 84||||cm||Standard Deviation|Mean
1315893|NCT02406937|Secondary|Body Weight||Baseline, Day 28, Day 56, Day 84||||g||Standard Deviation|Mean
1315894|NCT02406937|Secondary|Eczema Duration||Throughout the study period (84 days)||||Days||Standard Deviation|Mean
1315895|NCT02406937|Secondary|Fecal Bacterium Concentration|bifidobacterium, lactobacillus, clostridium perfringens|Baseline, Day 21||||log (colony forming units)||Standard Deviation|Mean
1315896|NCT02406937|Secondary|Fecal Laboratory Detection for sIgA||Baseline, Day 84||||ug/ml||Standard Deviation|Mean
1315897|NCT02406937|Secondary|Number of Participants With Eczema||Throughout the study period (84 days)||||participants|||Number
1315898|NCT02406937|Secondary|Body Length|Body length|Baseline, Day 28, Day 56, Day 84||||cm||Standard Deviation|Mean
1315899|NCT02406937|Secondary|Fecal Concentration of Short Chain Fatty Acid|fecal concentration of acetate, propionate and butyrate acid|Baseline, Day 21||||mg/g||Standard Deviation|Mean
1315900|NCT02406937|Secondary|Crying Time|Questionnaire recorded by parents. Average crying time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12||||minutes/day||Standard Deviation|Mean
1315901|NCT02406937|Secondary|Stool Consistency|"Average Bristol Score during the measurement week. The seven types of stool are:~= Separate hard lumps, like nuts (difficult to pass)~= Sausage-shaped but lumpy~= Like a sausage but with cracks in its surface~= Like a sausage or snake, smooth and soft~= Soft blobs with clear-cut edges (passed easily)~= Fluffy pieces with ragged edges; a mushy stool~= Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing excess liquid, and 5, 6 and 7 tending towards diarrhoea."|Baseline, Week 4, Week 8, Week 12||||units on a scale||Standard Deviation|Mean
1315902|NCT02406937|Secondary|Number of Participants With Gastrointestinal Symptoms|Number of participants with symptom of bloating and abdominal pain|Weekly (Baseline to Day 84)||||participants|||Number
1315903|NCT02406937|Primary|Stool Frequency|Average daily stool frequency during the measurement week|Baseline, Week 4, Week 8, Week 12||||Times per day||Standard Deviation|Mean
1315904|NCT02406586|Secondary|Change in Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in milliseconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Baseline, 6 weeks|||||||
1315905|NCT02406586|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 6 Weeks|Blood samples were collected for measurement of free fatty acids at baseline and 6 weeks after the Intralipid 20% infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 6-week FFA levels from baseline FFA levels.|Baseline, 6 weeks|||||||
1315906|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||percent change in diameter||Standard Deviation|Mean
1315907|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||percent change in diameter||Standard Deviation|Mean
1315908|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject on the salsalate arm withdrew from the study was not included in the baseline analysis population.|||percent change in diameter||Standard Deviation|Mean
1329602|NCT02107014|Primary|Change in IL-27 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1315909|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||percent change in diameter||Standard Deviation|Mean
1315910|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
1315911|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Week 6), within 20 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
1315912|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Week 6), within 16 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
1315913|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
1315914|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure from at Week 6 from pre-dosing with Intralipid to 8 hours during Intralipid infusion.|Pre-dose (Week 6), within 8 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
1315915|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Week 6), within 4 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
1315916|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
1315917|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Baseline), within 20 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
1315918|NCT02406586|Secondary|Change in Expression of Inflammatory Biomarkers (Interleukin-1 (IL-1), Interleukin-6 (IL-6), Interleukin-12 (IL-12), Tumor Necrosis Factor Alpha (TNF-alpha), and C-Reactive Protein (CRP))|IL-1, IL-6, IL-12, TNF-alpha, and CRP are inflammatory biomarkers. Each was measured by using microsphere-based flow cytometric immunoassay. Change is the difference between 6-week inflammatory biomarkers from baseline inflammatory biomarkers.|Baseline, 6 weeks|||||||
1315919|NCT02406586|Secondary|Change in Augmentation Index (AIx)|AIx is a surrogate measure of peripheral arterial resistance and is measured by analysis of the pulse wave at the radial artery. The AIx is calculated as the ratio of the pulse pressure at the second systolic peak to that at the first systolic peak. Change is the difference between 6-week AIx from baseline AIx.|Baseline, 6 weeks|||||||
1315920|NCT02406586|Secondary|Change in Oxidative Stress Markers|Oxidative stress was measured by using liquid chromatography to collect plasma glutathione and glutathione disulfide. Change is the difference between 6-week plasma glutathione and glutathione disulfide from baseline plasma glutathione and glutathione disulfide.|Baseline, 6 weeks|||||||
1315921|NCT02406586|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Weeks|Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 6-week diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 6 weeks|||||||
1315922|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Baseline), within 16 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
1315923|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
1315924|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. from Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 8 hours during Intralipid.|Pre-dose (Baseline), within 8 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
1315925|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Baseline), within 4 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
1315926|NCT02406495|Secondary|Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D|Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
1315927|NCT02406495|Secondary|Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D|Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
1315928|NCT02406495|Secondary|Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D|Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
1315929|NCT02406495|Secondary|Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D|Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
1315930|NCT02406495|Secondary|Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D|Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
1315931|NCT02406495|Secondary|Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.|1 Week||||percentage of participants|||Number
1315932|NCT02406495|Secondary|Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315933|NCT02406495|Secondary|Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315934|NCT02406495|Secondary|Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315935|NCT02406495|Primary|Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D|Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.|Baseline and 1 Week||||percentage of eyes|||Number
1315936|NCT02406495|Primary|Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D|"Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.~Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement"|Baseline and 1 Week||||percentage of mean lens tightness||Standard Deviation|Mean
1315937|NCT02406495|Primary|Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D|"Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.~(Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)."|Baseline and 1 Week||||percentage of eyes|||Number
1315938|NCT02406495|Primary|Lens Fit, Centration - Filcon IV 1 and Ocufilcon D|Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable|Baseline and 1 Week||||percentage of eyes|||Number
1315939|NCT02406495|Secondary|Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
1315940|NCT02406495|Secondary|Visual Acuity - Filcon IV 1 and Ocufilcon D|Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).|Baseline and 1 Week||||LogMAR||Standard Deviation|Mean
1315941|NCT02406443|Secondary|Change in Effective Renal Plasma Flow (ERPF)|ERPF (para-aminohippurate clearance) 3Hrs post-study drug administration after 1 month compared to ERPF at 3Hhrs post-study drug administration after 1 dose, sitagliptin vs placebo|3 Hrs post-administration after 1 month and after 1 dose||||ml per min per 1.73 m2||Standard Deviation|Mean
1315942|NCT02406443|Secondary|Change in Systolic Blood Pressure (SBP), Non-invasive Cardiac Output Monitoring|SBP by Non-Invasive cardiac output monitoring at 3Hrs post- study drug administration after 1 month compared to SBP by Non-invasive cardiac output monitoring at 3Hrs after 1 dose, sitagliptin vs placebo|3 Hrs post-administration after 1 month and after 1 dose||||mmHg||Standard Deviation|Mean
1315943|NCT02406443|Secondary|Change From Baseline in SDF-1alpha^3-67 (Truncated) Measured by Tandem Mass Spectrometry With Antibody-based Affinity Enrichment|Plasma concentration of SDF-1alpha^3-67 (intact) measured by quantitative mass spectrometry methods after antibody-based affinity enrichment, sitagliptin vs. placebo|3Hrs vs baseline after 1 dose||||ng per mL||Standard Deviation|Mean
1315944|NCT02406443|Secondary|Change From Baseline in SDF-1alpha^1-67 (Intact) Measured by Immunoaffinity and Tandem Mass Spectrometry|Plasma concentration of SDF-1alpha^1-67 (intact) measured by quantitative mass spectrometry methods after antibody-based affinity enrichment, sitagliptin vs. placebo|3 Hr vs. baseline after 1 dose||||ng per mL||Standard Deviation|Mean
1315945|NCT02406443|Secondary|Change in Fractional Excretion of Lithium (FELi)|FELi at 3 Hr post-study drug administration after 1 month compared to FELI at 3hrs post-study drug administration after 1 dose, sitagliptin vs. placebo|3 Hrs post-administration after 1 month and after 1 dose||||percentage of change||Standard Deviation|Mean
1315946|NCT02406443|Secondary|Change in Glomerular Filtration Rate (GFR)|Measured GFR (Inulin Clearance) at 3Hrs post study-drug after 1 month compared to Measured GFR at 3Hrs post-study drug after 1 dose, sitagliptin vs. placebo|3 Hrs post-administration after 1 month and after 1 dose||||ml per min per 1.73 m2||Standard Deviation|Mean
1315947|NCT02406443|Primary|Percent Change in Fractional Excretion of Sodium (FENA)|FENA at 3Hrs post-study drug administration after 1 month compared to FENA at 3Hrs post-study drug administration after 1 dose expressed as percent change, sitagliptin vs. placebo|3 Hrs post-administration after 1 month and after 1 dose||||percentage of change||Standard Deviation|Mean
1315948|NCT02405429|Primary|Difference Between Rectal and Axillary Temperatures|Rectal temperature minus axillary temperature|Within 2 minutes of each other|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
1315949|NCT02405429|Primary|Difference Between Temporal Artery and Rectal Temperatures|Rectal temperature minus temporal artery temperature|Within 2 minutes of each other|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
1315950|NCT02405429|Primary|Rectal Temperature|With thermistor probe and telethermometer|Single measurement within 2 minutes of temporal artery and axillary temperature measurements|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
1315951|NCT02405429|Primary|Axillary Temperature|With commercial digital thermometer|Single measurement within 2 minutes of temporal artery and rectal temperature measurements|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
1315952|NCT02405429|Primary|Temporal Artery Temperature|With commercial infrared temporal artery thermometer|Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
1315953|NCT02405390|Secondary|Time for Intubation|Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.|During the process of intubation (less than one minute)||||second||Standard Deviation|Mean
1315954|NCT02405390|Primary|Head Motion - Extension or Flexion|Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.|During the process of intubation (less than one minute)||||degrees of extension||Standard Deviation|Mean
1315955|NCT02404649|Secondary|To Assess Implant Survival||2 years|||||||
1315956|NCT02404649|Secondary|Evaluate Crestal Bone Levels||2 years|||||||
1315957|NCT02404649|Secondary|Level of Bone Maturation||2 years|||||||
1315958|NCT02404649|Primary|Resonance Frequency Values of Dental Implants|Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.|8 months||||units on a scale||Standard Deviation|Mean
1316134|NCT02403154|Secondary|Implant Breakage or Failure Rates|We will compare the implant failure/breakage rate between the two interventions.|24 hours - 24 months|No analyses were done on this study. We did not enroll enough patients in order to come to any conclusions prior to the PI leaving the institution.||||||
1315959|NCT02404545|Secondary|Number of Participants Who Develop Mesh Related Complications|"Assessed by physical examination including:~Mesh erosion and infection~Stomal stenosis and necrosis~Frequency of stoma pouch appliance changes.~Record by physical exam the incidence of parastomal hernia at 5 years."|60 months|The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.||||||
1315960|NCT02404545|Primary|Rate of Reduction of the Incidence of Parastomal Hernia|Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination|18 months|The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.||||||
1315961|NCT02404532|Secondary|Number of Participants With AEs Due Study Treatment and MIND1 System|Safety and tolerability of the system components was assessed by the device-related AEs, non-serious AEs (NSAEs), serious AEs (SAEs), AEs leading to discontinuation, and unanticipated adverse device effects.|At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)|The Safety sample included all participants who had ingested at least 1 dose of a placebo-embedded IEM, which was the same as the ITT dataset.|||participants|||Number
1315962|NCT02404532|Secondary|The Latency Period Between the Patch Detection of an Ingestion Event (eg, the Acquisition Time Stamp) and the Detection of the Ingestion Event in the Otsuka Cloud Server (eg, Server Time Stamp).|All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the latency period between the patch detection of an ingestion event and the detection of the ingestion event on the Otsuka Cloud Server which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline ingestion tile after each scheduled ingestion event. The various information transmissions measured were patch Acquisition of IEM to Medical Device Data Systems (MDDS), MDDS to Otsuka software application registration, Otsuka software application registration to Cloud Server and patch Acquisition of IEM to Cloud Server|Day 1 Visit at 0, 2, 4 and 6 hours|ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.|||Minutes||Standard Deviation|Mean
1315963|NCT02404532|Primary|Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch|All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To evaluate the latency period between site-reported ingestion time and detection of the ingestion event by the patch which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline.|Day 1 Visit at 0, 2, 4 and 6 hours|ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.|||Minutes||Standard Deviation|Mean
1315964|NCT02404532|Primary|Accuracy of Placebo-embedded IEM Detection by the MIND1 System Measured by the Percentage of Participants With IEM Detection Reported for Each of the 4 Time Points|All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the accuracy of IEM detection by the MIND1 System using the placebo + IEM by the proportion of participants with IEM detection reported for each of the 4 time points.|Day 1 Visit, at hours 0, 2, 4, 6|ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.|||Participants|||Count of Participants
1315965|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Recommend Product|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is I would recommend this product to another parent."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315966|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – How Productive Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315967|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – How Alert Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315968|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – How Rested Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316380|NCT02393209|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
1315969|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Caregiver Energy Levels Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315970|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Amount of Time Caregiver Awake|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1315971|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Number of Times Caregiver Woke Up|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
1315972|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Amount of Sleep Caregiver Got Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1315973|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Child Wanted to Play Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315974|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Child's Mood Upon Waking in Morning|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315975|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Child's Mood Over Past Week|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315976|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315977|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315978|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315979|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Skin Feels Soft Overall|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315980|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Skin Looks Healthy Overall|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315981|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 – Skin Looks Smooth Overall|"Questions were answered after 14 days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315982|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – How Productive Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315983|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – How Alert Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315984|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – How Rested Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315985|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Caregiver Energy Levels Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315986|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Amount of Time Caregiver Awake|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1315987|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Number of Times Caregiver Woke Up|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
1315988|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Amount of Sleep Caregiver Got Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1315989|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Child Wanted to Play Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315990|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Child's Mood Upon Waking in Morning|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315991|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Child's Mood Over Past Week|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315992|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315993|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316135|NCT02403154|Primary|Functional Outcomes (PROMIS v1.2-Physical Function Instrument)|The primary objective is to compare functional outcomes between subcutaneous internal fixation and external fixation as measured by the PROMIS v1.2-Physical Function instrument.|24 hrs - 24 months|No data was analyzed for this study. The PI left our institution and the study was pre-maturely closed. With such a small patient population, the data that was collected was not analyzed because achieving statistical significance was not possible.||||||
1315994|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315995|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Skin Feels Soft Overall|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315996|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Skin Looks Healthy Overall|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315997|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 – Skin Looks Smooth Overall|"Questions were answered after seven days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315998|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1315999|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316000|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316001|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Skin Feels Soft Overall|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316002|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Skin Looks Healthy Overall|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316003|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 – Skin Looks Smooth Overall|"Questions were answered after three days of treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316004|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316005|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316006|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316007|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Skin Feels Soft Overall|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316008|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Skin Looks Healthy Overall|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316009|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Skin Looks Smooth Overall|"Questions were answered after treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316010|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – How Productive Caregiver Felt Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316011|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – How Alert Caregiver Felt Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316012|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – How Rested Caregiver Felt Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316013|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Caregiver Energy Levels Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316014|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Amount of Time Caregiver Awake|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316015|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Number of Times Caregiver Woke Up|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
1316016|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Amount of Sleep Caregiver Got Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316017|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Child Wanted to Play Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316018|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Child's Mood Upon Waking in Morning|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316158|NCT02402127|Secondary|Average Coefficient of Friction of Unworn Lenses|Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.|Day 1 (each product)|Intention to treat participants with non-missing observations|||unitless|Participants|Standard Deviation|Mean
1316019|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Child's Mood Over Past Week|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316020|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Baby’s Skin Feels Soft in Areas Affected by Eczema|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316021|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Baby’s Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316022|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Baby’s Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316023|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Skin Feels Soft Overall|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316024|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Skin Looks Healthy Overall|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316025|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Skin Looks Smooth Overall|"Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316026|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316027|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316028|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of naps||Standard Deviation|Mean
1316029|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316030|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316381|NCT02393209|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-117||Cycle 1 Day 1 pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose|This analysis was not performed due to lack of data.||||||
1329603|NCT02107014|Primary|Change in IL-31 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1316031|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
1316032|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
1316033|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
1316034|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316035|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours.minutes||Standard Deviation|Mean
1316036|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316037|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316038|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316039|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316040|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of naps||Standard Deviation|Mean
1316041|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316042|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316159|NCT02402127|Primary|Average Coefficient of Friction of Worn Lenses at 16 Hours|Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1, Hour 16, each product|Intention to treat participants with non-missing observations|||unitless||Standard Deviation|Mean
1316043|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
1316044|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
1316045|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
1316046|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316047|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours.minutes||Standard Deviation|Mean
1316048|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316049|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316050|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316051|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316052|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of naps||Standard Deviation|Mean
1316053|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316054|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
1316821|NCT02380742|Primary|VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain|Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)|Removal of Pessary||||Centimeters||Standard Error|Least Squares Mean
1316055|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
1316056|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
1316057|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
1316058|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316059|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours.minutes||Standard Deviation|Mean
1316060|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316061|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
1316062|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 14 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316063|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 7 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316064|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 3 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316065|NCT02404493|Secondary|Dryness Scale Score on Day 14 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316066|NCT02404493|Secondary|Dryness Scale Score on Day 7 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316067|NCT02404493|Secondary|Dryness Scale Score on Day 3 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316068|NCT02404493|Secondary|Dryness Scale Score on Day 1 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316210|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs were collected after the participant has rested in the supine position for at least 5 minutes.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||bpm||Standard Deviation|Mean
1316069|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316070|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316071|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316072|NCT02404493|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316073|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316074|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316075|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316076|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
1316077|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 14 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1316078|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 7 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1316079|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 3 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1316627|NCT02388269|Secondary|Number of Participants With Adverse Events|Summary of Treatment Emergent Adverse Events. Subjects were monitored for occurrence of adverse events from the start of the run-in period to the end of the open label period..|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Safety Population|||Participants|||Count of Participants
1316080|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 24 Hours After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1316081|NCT02404493|Primary|Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 12 Hours After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1316082|NCT02404493|Primary|Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
1316083|NCT02404389|Secondary|Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined|Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined|Baseline, Week 8|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||percent change||Standard Deviation|Mean
1316084|NCT02404389|Primary|Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined|Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined|Baseline, Week 20|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||percent change||Standard Deviation|Mean
1316085|NCT02404389|Secondary|Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined|Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined|week 8, week 16|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
1316086|NCT02404389|Secondary|Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined|Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined|Week 20|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
1316087|NCT02404389|Secondary|Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined|Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined|week 8, week 16|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
1316088|NCT02404389|Primary|Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined|Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined|Week 20|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
1316089|NCT02404389|Primary|Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks|Number of participants with at least one AE/SAE in the category up to 20 weeks|20 weeks|The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis.|||participants|||Number
1316090|NCT02404103|Primary|Impulse Oscillometry (IOS) Resistance 5 (R5)|Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction.|initial visit and six week followup|Only data for subjects who completed study are presented.|||cmH2O(L/s)||Standard Deviation|Mean
1316091|NCT02404103|Primary|Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)|Indirectly assess small airway function.|baseline and six week followup|Those subjects that completed the study protocol.|||% of predicted||Standard Deviation|Mean
1316092|NCT02404103|Primary|Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment|A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement.|Baseline and six week followup|Those subjects that completed the study protocol.|||cmH2O/L||Standard Deviation|Mean
1316094|NCT02403895|Secondary|Estimated Pharmacokinetic Exposure to AZD2014 Through the Use of Population PK Modelling|Group B patients: PK parameters for AZD2014 estimated from a sparse PK sampling regimen and use of population PK modelling techniques (may be reported outside the clinical study report (CSR))|Assessment at multiple timepoints in Group B patients between study day 1 and day 3. Samples will be taken at 3 points on day 1 and at predose and at a further 2 points on day 3|The exposure of AZD2014 could not be estimated using a population PK model because there were insufficient subjects with intensive PK sampling (n=2) to develop at population PK model||||||
1316095|NCT02403895|Secondary|Evaluate the Effect of the Combination of AZD2014 and Paclitaxel on Pharmacokinetics Assessment of Cmax|To determine the effect of co-administration of paclitaxel on the PK of oral AZD2014 and the effect of co administration of oral AZD2014 on the PK of paclitaxel (Group A) by: PK parameters for each in the presence and absence of the other by intensive PK sampling and NCA techniques.|Assessment at multiple timepoints in Group A patients. Samples will be taken at pre-dose and at 10 further timepoints on day 1 and at pre-dose and 9 further timepoints on days 3 and 8|Data insufficient for full PK parameter evaluation or comparisons made between AZD2014 and paclitaxel|||ng/mL||Full Range|Mean
1316096|NCT02403895|Secondary|Progression Free Survival: Median Number of Days Between Start of Dosing Until Objective Disease Progression Through Measurement of Tumour Lesion Sizes|Assessment of the duration of progression free survival through assessment of tumour lesions by RECIST 1.1 criteria|From date of first dose until documented progression or end of life (Approx 3 months)||||Days||95% Confidence Interval|Median
1316097|NCT02403895|Secondary|Change in Tumour Size: Median Percentage Change in Tumour Size in mm by Measurement of Tumour Lesion Sizes|Assessment of the degree of tumour response through measurement of the change in tumour lesion sizes|From baseline until documented progression (Approx 3 months)||||% change||Full Range|Median
1316098|NCT02403895|Secondary|Disease Control Rate: Percentage of Patients Who Achieve Partial Response, Complete Response or Stable Disease Through Assessment of Tumour Lesion Sizes|Assessment of the disease control rate, percentage of patients who experience a response through assessment of tumour lesions by RECIST 1.1 criteria|From first dose until documented progression and at least 6 weeks after the start of treatment for assessment of Stable Disease - Assessed at 6, 13 and 20 Weeks||||Percentage of patients||80% Confidence Interval|Number
1316099|NCT02403895|Secondary|Duration of Response: Median Number of Days From the Date of First Documented Response Until the Date of Documented Progression Through Measurement of Tumour Lesion Sizes|Assessment of the duration of tumour response through assessment of tumour lesions by RECIST 1.1 criteria. Response is defined as the point at which the criteria for Partial Response (PR) was met) >=30% decrease in sum of target lesion longest diameter. Progression is defined as the point at which the criteria for Progressive Disease (PD) was met >=20% increase in sum of target lesion longest diameter, or until end of life.|From date of first documented response until documented progression or end of life in the absence of progression (Approx 3 months)|No participant responded therefore no duration of response data to report||||||
1316100|NCT02403895|Secondary|Best Objective Response: Number of Patients Who Experienced a Best Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not-Evaluable (NE), Through Measurement of Tumour Lesion Sizes.|Per Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed through imaging (CT or MRI scan) or clinical examination; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR) >=30% decrease in sum of target lesion longest diameter; Progressive Disease >=20% increase in sum of target lesion longest diameter; Stable Disease (SD) increase or decrease amounting to neither PR or PD. Overall tumour assessment based on quantitative assessment of target lesions and qualitative assessment of non-target lesions in line with RECIST criteria.|From Baseline until Disease Progression (Approx 3 months)||||Count of Participants|||Number
1316101|NCT02403895|Secondary|Overall Survival: Median Number of Days Between the First Dose and End of Life Due to Any Cause|Assessment of the duration of overall survival in weeks through direct patient follow-up. Any patient not known to have died at the time of analysis censored at the last recorded date the patient was known to be alive|From first dose until end of life (Approx 9 months)||||Days||95% Confidence Interval|Median
1316102|NCT02403895|Secondary|Number of Patients Who Experienced at Least One Adverse Event (AE) or Serious Adverse Event (SAE)|"The safety and tolerability of AZD2014 with weekly paclitaxel as assessed with the collection of Adverse Events and Serious Adverse Events as reported during clinic visits. In addition, clinical assessments were made throughout the on treatment period including blood test for chemistry, haematology, and blood clotting. In addition to clinical observations such as vital signs, and cardiac function through the use of ECG.~Any findings from the above assessments which were considered to be abnornal and clinically significant by the doctor were reported as (AEs or SAEs)."|Informed consent until end of safety follow up (Approx 10 months if all treatment cycles are completed)||||Count of Participants|||Number
1316103|NCT02403895|Primary|Percentage of Patients Who Have a Partial Response or Complete Response Through Measurement of Tumour Lesion Sizes|Calculation of the percentage of patient who have a Complete Response or Partial Response to treatment which is confirmed by a repeat assessment 4 weeks later|From first dose until disease progression (Approximately 3 months)|Analysis Set: Evaluable for efficacy set. All dosed patients with a baseline tumour assessment|||Percentage||90% Confidence Interval|Number
1316104|NCT02403830|Secondary|AUC of Ticagrelor Plasma Levels|The area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC) was calculated based on ticagrelor plasma levels|6 hours||||ng*hr/mL||Full Range|Geometric Mean
1316105|NCT02403830|Secondary|Platelet Reactivity Measured by VASP|Platelet reactivity measured by VASP 2 hours after ticagrelor loading dose and reported as platelet reactivity index (PRI)|2 hours||||PRI||95% Confidence Interval|Least Squares Mean
1316106|NCT02403830|Primary|Platelet Reactivity Measured by VerifyNow P2Y12|Platelet reactivity measured by VerifyNow P2Y12 2 hours after ticagrelor loading dose and reported as P2Y12 reaction units (PRU)|2 hours||||PRU||95% Confidence Interval|Least Squares Mean
1316107|NCT02403674|Secondary|Plasma Concentration of Doravirine at Week 48|Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose.|0 hours post-dose and 2 hours post-dose on Week 48|The analysis population consists of all randomized participants in the MK-1439A arm who received ≥1 dose of study drug and had doravirine concentration data available.|||nM||Standard Deviation|Mean
1316108|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA BLoQ at Week 96|The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 96 will be determined. Plasma HIV RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. Data will be handled as observed.|Week 48|The analysis population will consist of all randomized participants who receive ≥1 dose of study medication and have baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
1316109|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48|The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed.|Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.|||Percentage of Participants|||Number
1316110|NCT02403674|Secondary|Change From Baseline in Fasting HDL-C at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline HDL-C data available as well as ≥1 HDL-C measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
1316111|NCT02403674|Secondary|Change From Baseline in Fasting Triglycerides at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline triglyceride data available as well as ≥1 triglyceride measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
1316112|NCT02403674|Secondary|Change From Baseline in Fasting Cholesterol at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline cholesterol data available as well as ≥1 cholesterol measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
1316113|NCT02403674|Secondary|Change From Baseline in Fasting Non-HDL-C at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline non-HDL-C data available as well as ≥1 non-HDL-C measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
1316114|NCT02403674|Secondary|Change From Baseline in Fasting LDL-C at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline LDL-C data available as well as ≥1 LDL-C measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
1316115|NCT02403674|Secondary|Percentage of Participants With Tier-2 Neuropsychiatric AEs|"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included depression and suicide/self-injury and psychosis and psychotic disorders."|Up to Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication.|||Percentage of Participants|||Number
1316116|NCT02403674|Secondary|Percentage of Participants Discontinuing From Study Medication Due to an AE(s)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 48|The analysis population consisted of all randomized participants who received ≥1 dose of study medication.|||Percentage of participants|||Number
1316117|NCT02403674|Secondary|Percentage of Participants Experiencing ≥1 AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 48|The analysis population consisted of all randomized participants who received ≥1 dose of study medication.|||Percentage of participants|||Number
1316118|NCT02403674|Secondary|Change From Baseline in CD4 Cell Counts at Week 96|The mean change from baseline in CD4 cell counts at Week 96 will be assessed using the Observed Failure (OF) approach. With the OF approach, baseline values will be carried forward for participants who discontinued prior to Week 96 due to lack of efficacy. Cell counts at Baseline and Week 96 will be measured and expressed as cells/mm^3, and percent change will then be calculated as [(Baseline counts - Week 96 counts)*100]. CD4 cell counts will be quantified by a central laboratory using a commercially available assay.|Baseline (Day 1) and Week 96|The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline CD4 data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
1316119|NCT02403674|Secondary|Change From Baseline in CD4 Cell Counts at Week 48|The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.|Baseline (Day 1) and Week 48|The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline and Week 48 CD4 data available.|||Percent Change from Baseline||95% Confidence Interval|Mean
1316822|NCT02380287|Other Pre-specified|Frequency of Binding Antibodies to BCD-85 Formation||day 57|||||||
1316120|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96|"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) snapshot approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses."|Week 96|The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
1316121|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48|"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason."|Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.|||Percentage of Participants||95% Confidence Interval|Number
1316122|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96|"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) snapshot approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses."|Week 96|The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
1316123|NCT02403674|Primary|Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)|"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included dizziness, sleep disorders and disturbances, and altered sensorium (including disturbance in attention)."|Up to Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication.|||Percentage of Participants|||Number
1316124|NCT02403674|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason."|Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.|||Percentage of Participants|||Number
1316125|NCT02403206|Secondary|Operating Time in the Eye to Complete Entire Cataract Procedure|Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|Intent-to-Treat Analysis Set|||seconds||Standard Deviation|Mean
1316126|NCT02403206|Primary|Percentage of Capsular Tears (Anterior or Posterior) During Surgery|A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|Intent-to-Treat Analysis Set|||percentage of capsular tears|||Number
1316127|NCT02403180|Secondary|Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.|Day 5, each product|Intention to treat participants with non-missing observations|||diopter*logMar||Standard Deviation|Mean
1316128|NCT02403180|Primary|Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear|Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.|Day 5, each product|Intention to treat participants with non-missing observations|||arcsec||Standard Deviation|Mean
1316129|NCT02403154|Secondary|Compare the Functional Outcome Scores (PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction With Sex Life, PROMIS Depression, Majeed Score, SF-12, VAS, Patient Satisfaction Score, and (Only in Men) PROMIS Erectile Function)|We will ask patients multiple questionnaires to asses their functional outcomes after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function.|24 hours - 24 months|||||||
1316130|NCT02403154|Secondary|Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)|We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome|24 hours - 24 months|||||||
1316131|NCT02403154|Secondary|Health-related Qualify of Life|We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function.|24 hours - 24 months|||||||
1316132|NCT02403154|Secondary|Revision Surgery Rates|We will compare the revision surgery rates between the two interventions.|24 hours - 24 months|||||||
1316133|NCT02403154|Secondary|Infection Rates|We will compare the rate of infection between the two interventions.|24 hours - 24 months|||||||
1316823|NCT02380287|Other Pre-specified|Frequency of Early Discontinuation Due to AE||57 days|||||||
1316136|NCT02402933|Other Pre-specified|Change in Blood Glucose Level Over Time|Glucometer-based measurements of blood glucose after the studied drug administration. The participants’ change in blood glucose level from baseline (just prior to dosing or right after the study drug administration) was measured by the caregiver using a glucometer at 15, 30 and 45 minutes after NG administration. The change in glucose was calculated from each time point (15, 30 and 45 minutes) minus the baseline.|Baseline (just prior to dosing or right after study drug administration), 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia|Participants received at least 1 dose of the NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1316137|NCT02402933|Secondary|Percentage of Participants With Adverse Events Through the Nasal Score Questionnaire|"Adverse events solicited through the Nasal Score Questionnaire included: runny nose, nasal congestion (nostrils plugged), nasal itching, sneezing, watery eyes, itchy eyes, redness of eyes, itching of ears, itching of throat, and other.~A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Within 2 hours of full recovery from a hypoglycemic event|Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event.Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population.|||percentage of participants|||Number
1316138|NCT02402933|Secondary|Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaire by the Caregiver|"Assess ease-of-use of intranasal administered glucagon in the hands of caregivers of participants who may be called upon to treat episodes of hypoglycemia.~Measurement for Degree of difficulty: opening the kit, Degree of difficulty: understanding the instructions on how to use the kit, Degree of difficulty: administering the medication into the nostril, Degree of satisfaction is 1 (Very Difficult) to 7 (Very Easy). Measurement for Dry Mist Nasal Glucagon will be easy to teach other caregivers, Nasal formulation of glucagon is less intimidating for caregivers, Dry Mist Nasal Glucagon is easy to carry and would be willing to carry it, Intranasal delivery of glucagon is preferable: level of agreement 1 (Strongly Disagree) to 7 (Strongly Agree)."|After each drug administration for an episode of hypoglycemia|"Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were excluded. Proportions and n are based on the total number of hypoglycemic events (N=33) of 14 participants; except Compare to Injectable is based on 8 events."|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
1316139|NCT02402933|Primary|Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration|Responses to questions completed by the caregiver are used to assess this outcome. An episode of severe hypoglycemia is generally defined as an event associated with severe neuroglycopenia usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose) administered by a third party. In this study moderate hypoglycemia is defined as an episode wherein the child/adolescent with diabetes has symptoms and/or signs of neuroglycopenia and has a blood glucose ≤3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]) based on a blood sample taken at or close to the time of treatment.|Within 30 minutes after each drug administration for an episode of hypoglycemia|Participants who received at least 1 dose of NG with evaluable treatment response. Events for which participants required external professional medical assistance or used injected glucagon or oral carbohydrates within 30 minutes and before responding were non-evaluable. The good clinical practice (GCP) non-compliant site were also excluded.|||participants|||Number
1316140|NCT02402764|Secondary|Overall Survival (OS)|Overall survival, defined as the time from randomization to death from any cause.|End of post-treatment 12 month follow-up, up to 24 months per participant|All participants|||months||95% Confidence Interval|Median
1316141|NCT02402764|Secondary|Progression-Free Survival (PFS)|Median time to progression. Progression-free survival is defined as time elapsed from the beginning of study treatment to the first documentation of radiologic progression as defined by standard RECIST criteria or death.|Up to 10 months|All participants|||months||95% Confidence Interval|Median
1316142|NCT02402764|Secondary|Duration of Overall Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death. The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented or death.|Up to 10 months|Participants with Complete Response or Partial Response||||||
1316143|NCT02402764|Secondary|Best Overall Response (OR)|The best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.|Up to 10 months|Participants with Complete Response or Partial Response||||||
1316144|NCT02402764|Primary|Clinical Benefit Rate|Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) ≥ 12 weeks of selinexor in patients with triple negative breast cancer (TNBC), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 10 months|All participants|||Participants|||Count of Participants
1316145|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-100)||Standard Deviation|Mean
1316824|NCT02380287|Other Pre-specified|Frequency of Grade 3-4 AEs||57 days|||||||
1316146|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
1316147|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
1316148|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
1316149|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
1316150|NCT02402322|Secondary|Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.|Beck Depression Inventory-II (BDI-II), Spanish adaptation (38, 39). This 21-item self-reported instrument evaluates symptoms of depression. Score range:0- 63, with 3 levels of severity, 10-18 mild depression, 19-29 moderate depression and >30 severe depression.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-63)||Standard Deviation|Mean
1316151|NCT02402322|Secondary|Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.|Beck Anxiety Inventory (BAI), Spanish adaptation . This 21-item self-reported instrument evaluates the cognitive and physical symptoms of anxiety. Score range:0- 63, with 3 levels of severity 0-21 mild anxiety, 22-35 moderate anxiety and 36-63 severe anxiety.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-63)||Standard Deviation|Mean
1316152|NCT02402322|Primary|Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.|This 18-item scale evaluates sensitivity to anxiety symptoms on 3 dimensions: physical, cognitive, and social.There are 3 subscales, physical, cognitive, and social. For both the subscales (which range from 0 to 24) and the total scale (which range from 0 to 72), higher scores correspond to greater anxiety sensitivity.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-72)||Standard Deviation|Mean
1316153|NCT02402322|Primary|Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.|Panic Disorder Severity Scale Self-Report (PDSS-SR). This 7-item scale assesses the severity of PD through questions about the frequency of panic attacks, associated distress, anticipatory anxiety, agoraphobic and interoceptive avoidance, and social and work impairment. Score range: 0-28. Scores up to 10 correspond with ‘‘mild,’’ those between 11 and 15 with ‘‘moderate,’’ and those at or above 16 with ‘‘severe’’ panic disorder.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-28)||Standard Deviation|Mean
1316154|NCT02402296|Secondary|Matrix Metallo-proteinase (MMP-1&9)|Their immuno-expression was assessed in the gingival samples harvested from the gingiva adjacent to hopeless teeth (planned to be extracted for dento-periodontal causes)|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.|||percentage of change||Standard Deviation|Mean
1316155|NCT02402296|Secondary|Gingival Index (GI)|"Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing~delayed bleeding on probing~immediate bleeding on probing~spontaneous bleeding"|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.|||percentage of change||Standard Deviation|Mean
1316156|NCT02402296|Secondary|Pocket Depth (PD)|It is the distance from the base of the pocket till the gingival margin using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings|||percentage of change||Standard Deviation|Mean
1316157|NCT02402296|Primary|Assessment of Change in Clinical Attachment Level (CAL)|It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis (LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings measurements|||percentage of change||Standard Deviation|Mean
1316825|NCT02380287|Other Pre-specified|Frequency of Local Reactions||57 days|||||||
1316826|NCT02380287|Other Pre-specified|Total Frequency of AE/SAE||57 days|||||||
1316160|NCT02401867|Primary|Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults|Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar’s test, a two-sample test for binomial proportions for matched-pair data.|1 day|Analytic sample =131: 10 participants did not receive both the vaginal self-swab HPV DNA test and the provider cervical test (reference); 7 received the self, but not the provider; 1 received the provider, but not the self; 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.|||Participants|||Count of Participants
1316161|NCT02401555|Primary|Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis|The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma (EDTA, heparin and sodium citrate). The Accuracy analysis on the serum samples is a proportion of results that are correctly identified as such.|Up to 9 months||||Percentage of True Results||95% Confidence Interval|Number
1316162|NCT02401529|Secondary|Average Frequency of Meals Per Day|average frequency of meals (1 meal, 2 meals, if more specify)|average number of meals consumed per day for the 1st three days post-surgery||||participants|||Number
1316163|NCT02401529|Secondary|Average Amount of Meal Per Day|adequacy of meals (inadequate, adequate)|3 days||||participants|||Number
1316164|NCT02401529|Secondary|Onset of 1st Post-operative Oral Intake|feeding onset (1st day i. surgery day, 2nd day, 3rd day)|Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery||||participants|||Number
1316165|NCT02401529|Primary|Total Number of Post-operative Vomiting Episodes|Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)|total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery||||participants|||Number
1316166|NCT02401529|Primary|Occurence of Postoperative Vomiting|Postoperative vomiting occurrence (yes, no)|7 days||||participants|||Number
1316167|NCT02401529|Primary|Duration of Post-operative Nausea|Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)|7 days||||participants|||Number
1316168|NCT02401529|Primary|Onset of Post-operative Nausea|Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)|onset of 1st ocurence of nausea attack within the 1st week post-surgery||||participants|||Number
1316169|NCT02401529|Primary|Occurence of Post-operative Nausea|Postoperative nausea occurence (yes, no)|7 days||||participants|||Number
1316170|NCT02401529|Primary|Duration of Post-operative Pain|4 selections (1 day, 2 days, 3 days, if more specify)|number of days at which pain was experienced within the the 1st sevn days post -surgery||||participants|||Number
1316171|NCT02401529|Primary|Maximum Severity of Post-operative Pain|5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)|The severest pain grade felt within a week||||participants|||Number
1316172|NCT02401464|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
1316173|NCT02401464|Secondary|Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
1316174|NCT02401464|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
1316175|NCT02401464|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
1316176|NCT02401464|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
1316177|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1316178|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1316179|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1316180|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1316827|NCT02380287|Other Pre-specified|Mean Pain Score by VAS Assessment During Injection of BCD-085||day 1|||||||
1316828|NCT02380287|Other Pre-specified|Clearance of BCD-085 After Single Subcutaneous Injection||57 days|||||||
1316181|NCT02401412|Secondary|Peristomal Skin Complication Rate|Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.|8 weeks|"The analysis population was defined as a modified ITT population which excluded subjects who~were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)~did not receive the study device; (n=1)~As such 153 (170-17) subjects were eligible for analysis"|||Participants|||Count of Participants
1316182|NCT02401412|Primary|Stoma Related Cost of Care|12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.|12 weeks|"The analysis population was defined as a modified ITT population which excluded subjects who~were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)~did not receive the study device; (n=1)~As such 153 (170-17) subjects were eligible for analysis"|||USD||95% Confidence Interval|Least Squares Mean
1316183|NCT02401256|Primary|Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose)|After the samples collection, blood from phase 2 and phase 4 were used to perform the quantification of Efavirenz in plasma. The composite of the efavirenz concentration (blood collection between 0 to 120 hrs) were used to calculate the area under the plasma concentration time curve (AUC0-inf for single dose and AUC0-24 for multiple dose) of efavirenz.|Single dose pharmacokinetics (PK) versus multiple doses (after 17 day pretreatment) PK (total 38 days for each subject)|Just volunteers with Efavirenz quantification information (complete or partial) and CYP2B6 genotype were included in this data analysis (Total of 61)|||h*uM||Standard Deviation|Mean
1316184|NCT02401230|Secondary|Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration|Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/million cells||Inter-Quartile Range|Median
1316185|NCT02401230|Secondary|Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration|Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
1316186|NCT02401230|Secondary|Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration|Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
1316187|NCT02401230|Secondary|Median Rectal Tissue Tenofovir (TDF) Concentration|Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
1316188|NCT02401230|Secondary|Median Rectal Tissue Emtricitabine (FTC) Concentration|Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
1316189|NCT02401230|Secondary|Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration|Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/million cells||Inter-Quartile Range|Median
1316190|NCT02401230|Secondary|Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration|Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/million cells||Inter-Quartile Range|Median
1316191|NCT02401230|Secondary|Median Rectal Secretion Tenofovir (TDF) Concentration|Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/swab||Inter-Quartile Range|Median
1316192|NCT02401230|Secondary|Median Rectal Secretion Emtricitabine (FTC) Concentration|Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/swab||Inter-Quartile Range|Median
1316193|NCT02401230|Secondary|Median Plasma Tenofovir (TDF) Concentration|Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/ml||Inter-Quartile Range|Median
1316194|NCT02401230|Secondary|Median Plasma Emtricitabine (FTC) Concentration|Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/ml||Inter-Quartile Range|Median
1316195|NCT02401230|Primary|Median Cumulative Amount of p24|The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||pg/mL||Inter-Quartile Range|Median
1316829|NCT02380287|Other Pre-specified|Constant of Elimination of BCD-085 After Single Subcutaneous Injection||57 days|||||||
1316830|NCT02380287|Other Pre-specified|Half-life of BCD-085 After Single Subcutaneous Injection||57 days|||||||
1316196|NCT02401230|Primary|Median Percentage of CD4 Positive T-Cells|HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use.|Baseline, Post-Intervention (Day 8)|The analysis population includes participants for whom the assay could be accurately performed. Data were not available for analysis in the case of an insufficient sample to perform this assay, poor performance of the assay, or technical issues in the laboratory.|||percentage positive T-cells||Inter-Quartile Range|Median
1316197|NCT02401022|Primary|Abstinence|The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13)|Weeks 10 - 13|Subjects who received at least one dose of AZD8529 were included in this population.|||Participants|||Count of Participants
1316198|NCT02400996|Primary|Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms|Of the 40 patients operated for Pancreatic Endocrine Neoplasms, using clinical criteria, histopathological analysis and preoperative imaging as gold standard, nonfunctioning and functioning tumours were identified. Similarly the number of benign and malignant lesions identified were recorded as per the WHO Classification of pancreatic endocrine tumours.|Each participant was followed up for a period of 5 years||||participants|||Number
1316199|NCT02400710|Secondary|Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record|Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.|16 weeks||||participants|||Number
1316200|NCT02400710|Primary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.|8 weeks||||units on a scale||Standard Deviation|Mean
1316201|NCT02400580|Other Pre-specified|Nausea Before Surgery as Compared to After Surgery|A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine. Less nausea is considered preferable to more nausea. The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group.|24 hours||||units on a scale||95% Confidence Interval|Mean
1316202|NCT02400580|Other Pre-specified|Readiness for Discharge|Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated. The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group.|24 hours|Patients who were asked about overall satisfaction with procedure at time of discharge using a Visual Analog Scale. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level.|||units on a scale||95% Confidence Interval|Mean
1316203|NCT02400580|Other Pre-specified|Number of Participants Who Vomited Within 24 Hours of Operation|A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one. Vomiting is reported as either having vomited or not vomited. The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group.|24 hours||||Participants|||Count of Participants
1316204|NCT02400580|Other Pre-specified|Having a Feeling of General Well-being at One Month|Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire. The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group.|4 weeks|The patients were asked to report their overall feeling of well being on a Visual Analog Scale one month after surgery. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level.|||units on a scale||95% Confidence Interval|Mean
1316205|NCT02400580|Secondary|Narcotic Medication Use|The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery. The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group. Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables.|24 hours|This analysis is of the total number of units of morphine used by each group over a 24 hour period that is composed of the amount of narcotics received in the operating room, recovery room as well as at 6,12, and 24 hours postoperatively.|||Morphine Equivalents||95% Confidence Interval|Mean
1316206|NCT02400580|Primary|Postoperative Pain|The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain.|24 hours||||units on a visual analog scale||95% Confidence Interval|Mean
1316207|NCT02400346|Primary|Number of Patients With Treatment-Emergent Adverse Events|Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit|Baseline to 30 weeks||||Participants|||Count of Participants
1316208|NCT02400333|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening, at admission on Day -1 to each treatment period and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
1316209|NCT02400333|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
1316211|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||mmHg||Standard Deviation|Mean
1316212|NCT02400333|Secondary|Percentage of Participants With Adverse Events (AEs).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||percentage of participants|||Number
1316213|NCT02400333|Secondary|Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX.|Assesssment of MRAUC [0-∞] (Ratio of metabolite AUC [0-∞] to parent AUC [0-∞], adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1316214|NCT02400333|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX.|Assesssment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1316215|NCT02400333|Secondary|Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX.|Assesssment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1316216|NCT02400333|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h||Standard Deviation|Mean
1316217|NCT02400333|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h||Full Range|Median
1316218|NCT02400333|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
1316266|NCT02397785|Secondary|Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Severity Scale|The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.|||units on a scale||Standard Deviation|Mean
1316831|NCT02380287|Other Pre-specified|Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days|||||||
1316219|NCT02400333|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
1316220|NCT02400333|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1316221|NCT02399345|Secondary|Percentage of Subjects With Post-treatment Relapse|Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment|Up to 12 weeks after last actual dose of active study drug|ITT population|||percentage of participants|||Number
1316222|NCT02399345|Secondary|Percentage of Subjects With On-treatment Virologic Failure|Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).|6 weeks|ITT population|||percentage of participants|||Number
1316223|NCT02399345|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1316224|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline up to Day 14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||μg/mL||Standard Deviation|Mean
1316225|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline to Day14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||microgram per mililitre(μg/mL )||Standard Deviation|Mean
1316226|NCT02399163|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||microgram per square centimeter(μg/cm^2)||Standard Deviation|Mean
1316227|NCT02399163|Secondary|Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||% SMHR||Standard Deviation|Mean
1316267|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) General Health Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316228|NCT02399163|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|Per-protocol (PP) population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||% SMHR||Standard Deviation|Mean
1316229|NCT02399111|Secondary|Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation|This study was terminated prior to collection of data.|30 days|||||||
1316230|NCT02399111|Primary|Incidence of Wound Infection With Szilagyi Grade|This study was terminated prior to gathering of data.|30 days|||||||
1316231|NCT02398227|Primary|Severity of Violence Against Women Scale (SVAWS)|Severity of Violence Against Women Scale total score. Scores can range from 0 to 138 with higher scores reflecting greater degree of violence/abuse.Adjusted means with baseline scores as a covariate are reported|baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatment|Analysis only include those who completed all time-points|||score on a scale||Standard Deviation|Mean
1316232|NCT02398227|Primary|Clinician Administered PTSD Scale (CAPS)|Clinical Interview assessing symptoms of Posttraumatic Stress Disorder (PTSD) scores can range from 0 to 136 with higher scores reflecting greater PTSD severity Adjusted means with baseline scores as a covariate are reported|baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment|Analysis include those participants who completed each follow-up time point.|||units on a scale||Standard Deviation|Mean
1316233|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 12, “How likely to comply if prescribed?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316234|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 11, “How satisfied with product?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316235|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 10, “How bothersome was nasal irritation?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
1316236|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 9, “Did product cause nasal irritation?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316382|NCT02393209|Secondary|TAK-117 Plasma Concentration in Phase 1b||Cycle 1 Day 1 pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose|The PK-evaluable population was defined as all participants for whom there are sufficient dosing and TAK-117 concentration-time data to permit non-compartmental PK analysis. Here 'Number Analyzed' are participants analyzed at the specific timepoint.|||ng/mL||Standard Deviation|Mean
1316237|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 8, “Did product feel soothing?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316238|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 7, “Did medicine run out of nose?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316239|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 6, “Did medicine run down throat?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316240|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 5, “How satisfied with aftertaste?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
1316241|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.|Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 4, “Did product have an aftertaste?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316242|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 3, “How satisfied not to have scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
1316280|NCT02397694|Secondary|PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State|Cmax is the maximum observed plasma concentration of the drug.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose|Pharmacokinetic (PK) Substudy Analysis Set included all participants who (1) were randomized into the double-blinded phase of study, (2) were enrolled into the PK substudy, (3) received at least 1 dose of study drug during the double-blinded phase, and (4) had at least 1 nonmissing intensive PK concentration value.|||ng/mL||Standard Deviation|Mean
1316243|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.|Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 2, “How satisfied with scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
1316244|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.|Delayed attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 1, “Did product have a scent/odor?” are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
1316245|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes using immediate attributes questionnaire, Question 9, “Did product make want to sneeze?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no urgency; 1: very slightly urgency; 2: slightly urgency; 3: neither slightly nor moderately urgency; 4: moderately urgency; 5; markedly urgency; 6: very markedly urgency. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
1316246|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Soothing|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 8, “Did product feel soothing?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
1316247|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 7, “Did medicine run out of nose?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
1316248|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 6, “Did medicine run down throat?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
1316281|NCT02397694|Secondary|Number of Participants With Treatment Emergent Laboratory Abnormalities||Up to 72 weeks|Safety Analysis Set|||Participants|||Count of Participants
1316282|NCT02397694|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||Up to 72 weeks|Safety Analysis Set included randomized participants who received at least 1 dose of randomized study drug.|||Participants|||Count of Participants
1316832|NCT02380287|Secondary|Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days|||||||
1316249|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 5, “How satisfied with immediate taste?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
1316250|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 4, “Did product have an immediate taste?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
1316251|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor|Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 3, “How satisfied not to have scent/odor?” are summarized. The immediate’ attributes questionnaire was completed immediately following each trt in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
1316252|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor|Immediate attributes questionnaire (ques) was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes ques, Question 2, “How satisfied with scent/odor?” are summarized. The immediate’ attributes ques was completed immediately following each treatment (trt) in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
1316253|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor|Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 1, “Did product have a scent/odor?” are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance (ANOVA) mixed model with participant as a random effect, and country, treatment, period, and Baseline (BL) rhinitis symptomatology subgroup (subgrp), and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg’s method.|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
1316254|NCT02397915|Secondary|Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire|An overall preference questionnaire (OPQ) was used to evaluate participants’ attribute preference for nasal spray therapy for the given treatment. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. Products attributes included scent/odor, immediate taste, after taste, less drip through throat (LDTT), less run out of nose (LRON), more soothing, less irritating and urge to sneeze (UTS). The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment (tmt) in Period 2. Overall participant preferences were analyzed using Prescott’s test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country (ctry) and symptomatology (sym). All preference p-values were also adjusted for multiplicity using Hochberg’s method.|Approximately four minutes after the administration of the second treatment|PP Population|||Participants|||Number
1316283|NCT02397694|Secondary|The Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||CD4 Cell Count (/μL)||Standard Deviation|Mean
1316284|NCT02397694|Secondary|The Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||CD4 Cell Count (/μL)||Standard Deviation|Mean
1316255|NCT02397915|Primary|Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.|An overall preference questionnaire (OPQ) was used to evaluate participants’ preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott’s test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg’s method.|Approximately four minutes after the administration of the second treatment|Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them.|||Participants|||Number
1316256|NCT02397785|Secondary|Change From Baseline in Weekly Opioid Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||morphine equivalents/week||Standard Deviation|Mean
1316257|NCT02397785|Secondary|Change From Baseline in Weekly Acetaminophen Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||mg/week||Standard Deviation|Mean
1316258|NCT02397785|Secondary|Change From Baseline in Weekly Naprosyn Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.|||mg/week||Standard Deviation|Mean
1316259|NCT02397785|Secondary|Change From Baseline in Weekly Ibuprofen Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.|||mg/week||Standard Deviation|Mean
1316260|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Total Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
1316261|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) Sub-Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
1316262|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Colorectal Anal Distress Inventory (CRADI) Sub-Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
1316263|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Pelvic Organ Prolapse Distress Inventory (POPDI) Sub-Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
1316264|NCT02397785|Secondary|Change From Baseline in Quality of Life on Female Sexual Function Index (FSFI) Scale|The Female Sexual Function Index is a validated, self-reported instrument used to evaluate sexual function and symptoms. The FSFI consists of 6 sub-scales: 1) desire [score range = 1.2 - 6], 2) arousal [score range = 0 - 6], 3) lubrication [score range = 0 - 6], 4) orgasm [score range = 0 - 6], 5) satisfaction [score range = 0 - 6], 6) pain [score range = 0 - 6]. The full FSFI consists of 19 questions, and the total score ranges from 1.2 - 36. Change = (Week 12 Score - Baseline Score). Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 FSFI scores available.|||units on a scale||Standard Deviation|Mean
1316265|NCT02397785|Secondary|Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Interference Scale|The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.|||units on a scale||Standard Deviation|Mean
1316268|NCT02397785|Secondary|Change From Baseline in Pain on Short Form 36 (SF-36) Pain Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316269|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Social Function Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316270|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Emotional Wellbeing Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316271|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Energy/Fatigue Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316272|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Emotional Problems Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316273|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Physical Health Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316274|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Physical Functioning Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
1316275|NCT02397785|Primary|Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 12|"The Visual Analog Scale assesses self-reported pain scores. Patients were asked to record their average pain over the past 4 weeks by placing an X on a 10-cm line, with 0 representing no pain and 100 representing the worst pain imaginable. Pain scores were determined by research personnel by measuring the distance (in mm) from 0 to the X. Change = (Week 12 Score - Baseline Score)."|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 VAS scores available.|||units on a scale||Standard Deviation|Mean
1316276|NCT02397694|Secondary|PK Parameter: t1/2 of BIC, FTC, TAF, and TFV|t1/2 was defined as the terminal elimination half-life of the drug|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose|PK Substudy Analysis Set|||hours||Inter-Quartile Range|Median
1316277|NCT02397694|Secondary|PK Parameter: AUCtau for BIC, FTC, TAF, and TFV|AUCtau is defined as the area under the concentration-time curve of the drug over time.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose|PK Substudy Analysis Set|||h*ng/mL||Standard Deviation|Mean
1316278|NCT02397694|Secondary|PK Parameter:Ctau for BIC, FTC and TFV|Ctau was defined as the observed drug concentration at the end of the dosing interval.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose|PK Substudy Analysis Set|||ng/mL||Standard Deviation|Mean
1316279|NCT02397694|Secondary|PK Parameter: Tmax for BIC, FTC,TAF, and TFV at Steady-State|Tmax was defined as the time to Cmax.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose|PK Substudy Analysis Set|||hours||Inter-Quartile Range|Median
1316285|NCT02397694|Secondary|The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||CD4 Cell Count (/μL)||Standard Deviation|Mean
1316289|NCT02397694|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1316290|NCT02397694|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 12|Full Analysis Set|||percentage of participants|||Number
1316291|NCT02397694|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set included all participants who were randomized into the double-blinded phase of study and received at least 1 dose of study drug during the double-blinded phase.|||percentage of participants|||Number
1316292|NCT02397655|Primary|Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography|"By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion.~By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion.~Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree."|30 days after subjects recruitment|We provide the vessel numbers with its stenosis degree ≥50% stenosis (including occlusion).|||artery numbers|||Number
1316293|NCT02397564|Secondary|Patient Preference|The number of patients who preferred the fractionated laser|5 months|Those who expressed a preference.|||Participants|||Count of Participants
1316294|NCT02397564|Primary|Patient Observer Scar Assessment Scale (POSAS)|It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.|5 months||||units on a scale||Standard Error|Mean
1316295|NCT02397122|Secondary|Tissue Thickness|under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe|6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
1316296|NCT02397122|Secondary|Keratinized Tissue Width|measured from margin of the gingiva to mucogingival junction by periodontal probe|6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
1316297|NCT02397122|Secondary|Attachment Level|measured from cementoenamel junction to gingival sulcus base by periodontal probe|6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
1316298|NCT02397122|Secondary|Probing Depth|measured from margin of the gingiva to gingival sulcus base by periodontal probe|6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
1316299|NCT02397122|Secondary|Horizontal Recession|measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe|6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
1316300|NCT02397122|Primary|Vertical Recession|Measured from cementoenamel junction to margin of the gingiva by periodontal probe|6 months||||mm||Standard Deviation|Mean
1316301|NCT02396537|Primary|Discomfort With Intranasal Midazolam Administration|"subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying No Hurt) and a maximum score of 10 (Hurts Worst). Values between include 2 (Hurts Little Bit), 4 (Hurts Little More), 6 (Hurts Even More), and 8 (Hurts Whole Lot.). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain)."|immediately after administration of intranasal midazolam||||units on a scale||Inter-Quartile Range|Median
1316302|NCT02396316|Secondary|Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1|NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.|From baseline to pre-dose at Week 1|FAS|||Percentage of participants|||Number
1316303|NCT02396316|Primary|Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1|It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.|From baseline to pre-dose at Week 1|FAS: The Full Analysis Set (FAS) included all randomized subjects who have received any study drug (including sham injection) and had had a baseline and at least one post-baseline IOP measurement on a posterior date. The FAS was analyzed as randomized.|||mmHg||Standard Deviation|Mean
1316304|NCT02396160|Secondary|Stress Incontinence Frequency|Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being stress incontinence frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||Number of stress incontinence episodes||95% Confidence Interval|Mean
1316305|NCT02396160|Primary|Nocturia Frequency|Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being nocturnal frequency ≥2 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of nocturnal micturitions||95% Confidence Interval|Mean
1316306|NCT02396160|Secondary|Urge Incontinence Frequency|Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urge incontinent frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of urge incontinence episodes||95% Confidence Interval|Mean
1316307|NCT02396160|Secondary|Urinary Urgency Frequency|Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urgency urination frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of urgency episodes||95% Confidence Interval|Mean
1316308|NCT02396160|Primary|Day Urinary Frequency|Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being day urination frequency ≥10 daytime micturitions per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of diurnal micturitions per day||95% Confidence Interval|Mean
1316309|NCT02396147|Secondary|Oral Clearance (CL/F) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||liters (L)/hr||Geometric Coefficient of Variation|Geometric Mean
1316310|NCT02396147|Secondary|Terminal Phase Elimination Half-Life (T1/2) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||hours||Standard Deviation|Mean
1316311|NCT02396147|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||hours||Full Range|Median
1316312|NCT02396147|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|From Day 1 to Day 26|Safety population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1316313|NCT02396147|Secondary|Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant|A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Days 1, 11, 21 and 26|Safety population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1316314|NCT02396147|Secondary|Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant|Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range.|Baseline and Days 4, 10, 14, 20, 24 and 26|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
1316315|NCT02396147|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)|Safety population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1316316|NCT02396147|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1316317|NCT02396147|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1316318|NCT02396147|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1316319|NCT02395822|Secondary|Number of Subjects Achieving Complete Response, Defined as in Vivo Donor Derived NK Cell Expansion of > 100 Donor Derived NK Cells.||Day 42 post NK cell infusion||||Participants|||Count of Participants
1316320|NCT02395822|Secondary|Treatment Related Mortality||6 months post-therapy|1 patient left the study|||Participants|||Count of Participants
1316324|NCT02395653|Secondary|Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)|Respiratory function and occurrence of CRRD was defined as simultaneous occurrence of bradypnoea (respiratory rate <10 breaths per minute for participants 9-15 years of age and sustained for 1 minute, or <8 breaths per minute for participants 16-17 years of age), with excessive sedation (that is, the participant is not easily aroused).|From the time of application of the first system through 7 days following end of study drug administration.|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||participants|||Number
1316325|NCT02395653|Secondary|Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal|Skin irritation at the SSEC application site was to be assessed immediately prior to placement of the study system and at 1 and 24 hours after removal of each study system. The application site was to be scored using the following scale: 0=No evidence of irritation; 1=Minimal erythema, barely perceptible; 2=Definite erythema, readily visible, minimal edema, or minimal papular response; 3=Erythema and papules; 4=Definite edema; 5=Erythema, edema, and papules; 6=Vesicular eruption; 7=Strong reaction spreading beyond the application site.|Baseline, 1 hour and 24 hours after SSEC removal.|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||units on a scale||Standard Deviation|Mean
1316326|NCT02395653|Primary|Assessment Of Adherence Of The SSEC System To Skin|The adhesion of each SSEC was evaluated immediately prior to removal at each 24-hour time point, or at early withdrawal. Adhesion was recorded using the following classification: System adhered to at least 90% of the application area with no edges unattached; System adhered between 75% and 89%; System was <75% adhered and not taped; System was secured with tape. The number of SSEC systems for all time points in each category is presented. Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.|Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||SSEC systems|SSEC systems used by 61 participants||Number
1316327|NCT02395653|Primary|Assessment Of Participant's Ability To Use The SSEC|Investigator's assessment of participant's ability to use the SSEC system safely and effectively. The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent). Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.|Completed at the time of the participant’s termination of study treatment (up to 72 hours after study drug administration)|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||participants|||Number
1316328|NCT02395536|Primary|Untoward Event Rate Associated With LINQ™ Insertions Performed|"Demonstrate that the untoward event rate associated with Reveal LINQ™ insertions performed in-office or in the traditional hospital setting (operating room, cardiac catheterization or EP laboratory) are comparable.~Untoward events are a composite of unsuccessful Reveal LINQ™ or complications related to the Reveal LINQ™ insertion procedure or system."|3 Months post insertion|Subjects exiting prematurely (prior to 3-month visit) without an untoward event were excluded from primary analysis. There were 7 excluded from the In office arm (2 deaths unrelated to the REVEAL LINQ and 5 premature exits) and 4 excluded from the traditional hospital setting arm (all 4 due to premature exit)|||Participants|||Count of Participants
1316329|NCT02395302|Primary|Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device|"A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below:~The device was comfortable to wear during Sustained Compression Mode.~The device was comfortable to wear during Intermittent Compression Mode.~The noise from the device was not bothersome.~The device was easy to put on.~The device was easy to take off.~The device was easy to use.~The device was light-weight and portable.~The use of the device helped my wound heal faster.~I would use the device again on another wound in the future.~Since using the device, my quality of sleep has improved.~It was a burden to come to the wound care clinic for my dressing changes.~The use of the device did not restrict many of my normal activities.~The device was cumbersome and interfered with my mobility.~I was able to work while being treated with the device."|4 weeks|"The Tolerance and Comfort questionnaire was completed at study exit by 16 participants (13 of the 16 total subjects completed the study, 2 were withdrawn by their site's Investigator, and 1 voluntarily withdrew).~Six participants were not employed during the time of questionnaire completion. Question 14 was not applicable to these participants."|||Participants|||Count of Participants
1316330|NCT02395185|Secondary|Oxygen Saturation|Oxygen saturation will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.|Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting|Because this was a crossover design, multiple casts were assessed for each participant|||percentage of SpO2|casts|Standard Deviation|Mean
1316331|NCT02395185|Secondary|Heart Rate|Heart rate will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.|Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.|Because this was a crossover design, multiple casts were assessed for each participant|||bpm|casts|Standard Deviation|Mean
1316343|NCT02394665|Secondary|Change in Quality of Life From Baseline in Study Participants|Change in quality of life during radiation and across the longitudinal progression-free interval compared to baseline. Change of quality of life will be assessed and scored via the FACT-Br behavioral questionnaire.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
1316344|NCT02394665|Secondary|Rate of Grade 3 or Higher Toxicity as a a Consequence of Study Therapy.|Rate of Grade 3 of Higher Toxicity in study participants as a consequence of study therapy.|2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
1316332|NCT02395185|Primary|NIPS (Neonatal Infant Pain Scale)|Each cast visit will be videotaped before, during, and after casting, and later reviewed for subjective evaluation of pain using NIPS (Neonatal Infant Pain Scale). The NIPS examines six behavioral groupings that contribute to a pain score ranging from 0 to 7: facial expression (relaxed muscles or grimace), cry (no cry, whimper, or vigorous cry), breathing patterns (relaxed, change in breathing), arms (relaxed/restrained, flexed/extended), legs (relaxed/restrained, flexed/extended), state of arousal (sleeping/awake, fussy). Scoring will take place by a trained study personnel blinded to the contents of the bottle. Scoring for all measures will be recorded at minute intervals. A pre casting score from the average of the first 3 minute scores prior to casting; a during casting score from the average of the scores at 1 minute intervals during casting; and a post casting score from the average of the 3 minute scores post casting. Scores are categorized as 0 no pain, to >4 severe pain.|Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.|Because this was a crossover design, multiple casts were assessed for each participant|||units on a scale|casts|Standard Deviation|Mean
1316333|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All volunteers who received one adalimumab injection.|||(ng/ml)*hour||Inter-Quartile Range|Median
1316334|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received adalimumab injection.|||(ng/ml)*hour||Inter-Quartile Range|Median
1316335|NCT02395055|Primary|Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received one injection of adalimumab.|||ng/ml||Inter-Quartile Range|Median
1316336|NCT02394925|Primary|Proportion of Successful Contact Lens Wearers|"Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, Overall Quality of Vision and Overall Comfort. Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded Excellent, Very Good or Good then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers."|2 months post wear|Subjects that completed all study visits without a major protocol deviation.|||Proportion of Subjects|||Number
1316337|NCT02394912|Primary|Technical Success Rate (See Description for Definition)|Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism (PE). Technical success rate is the proportion of successful deployments relative to the number of overall attempts in non roll-in subjects.|Day 1||||Participants|||Count of Participants
1316338|NCT02394808|Primary|Subjective Overall Quality of Vision|Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|11 days post fit|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
1316339|NCT02394808|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|11 days Post fit|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
1316340|NCT02394756|Primary|Subjective Overall Quality of Vision|Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120.|1-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
1316341|NCT02394756|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120.|1-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
1316342|NCT02394665|Secondary|Patterns of Failure in Study Participants Post-Protocol Therapy|Patterns of Failure will be assessed by determining the number of failures that arise in-field compared to the number that arise out–of-field. In-field failure will be defined as those where greater than 80% of the recurrence volume was encompassed by the 95% prescription isodose line. In addition, we will also describe failures by three types: unifocal, multifocal and diffuse (multicentric including leptomeningeal dissemination).|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
1316371|NCT02393547|Secondary|BMI|Change in BMI from baseline to week 12|12 weeks|subjects (N=10) who met criteria for prolonged smoking abstinence at week 12|||kg/m^2||Standard Deviation|Mean
1316372|NCT02393547|Secondary|Smoking Abstinence Rates|prolonged smoking abstinence at week 12|12 weeks||||Participants|||Count of Participants
1316345|NCT02394665|Secondary|Rate of Progression-Free Survival (PFS) in Study Patients|Rate of progression-free survival in study participants. Progression-free survival (PFS) is defined as the time elapsed from the start of study treatment to the date of documented progression events. For progression-free patients (without progression events), PFS will be censored at the last date of documented PF status.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
1316346|NCT02394665|Primary|Rate of Overall Survival (OS) in Study Patients|The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
1316347|NCT02394600|Secondary|Analysis of Blood Samples for Potential Biomarkers by Comparing Baseline and Post-treatment Samples.|To determine potential biomarkers predictive of clinical efficacy for birch pollen-induced AR following treatment with Grastek®|4 months|As the primary outcome showed that there was no significant difference between Grastek and placebo this outcome was not able to be completed.||||||
1316348|NCT02394600|Primary|Change in Total Nasal Symptom Score (TNSS) From Baseline to Post-treatment.|"To determine the effect of 4 months of treatment with Grastek® on the symptoms of birch pollen induced AR in participants with both timothy grass pollen-induced and birch pollen-induced allergen rhinitis (AR)~TNSS is comprised of the sum of 4 symptoms: runny nose, itchy nose sneezing and nasal congestion. Each of these symptoms are evaluated based on a 4 point Likert scale from 0-3. 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. TNSS can therefore have a range from 0 to 12."|4 months|93 participants were randomized into this study. The final number of participants that completed and were included for analysis are listed above.|||Scores on a scale||95% Confidence Interval|Mean
1316349|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|7 day post procedure||||units on a scale||Standard Deviation|Mean
1316350|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|3 day post procedure||||units on a scale||Standard Deviation|Mean
1316351|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete activities of daily living (ADLs)|1 day post procedure||||units on a scale||Standard Deviation|Mean
1316352|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|7 days post procedure||||units on a scale||Standard Deviation|Mean
1316353|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|3 days post procedure||||units on a scale||Standard Deviation|Mean
1316354|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|1 day post procedure||||units on a scale||Standard Deviation|Mean
1316355|NCT02393950|Secondary|Quantitative EEG|Quantitative analysis of EEG|Pre-dose and at 1, 6 and 10 h post dose at each dose level|||||||
1316356|NCT02393950|Secondary|Dexterity and Reaction Times|Selected battery of psychomotor tests|Pre-dose and at 1 and 6h post dose at each dose level|||||||
1316357|NCT02393950|Secondary|Sedation Scores on a Visual Analogue Scale (VAS)|Assessment of sedation by subject|Pre-dose and at 1, 6 and 10.5h post dose at each dose level|||||||
1316358|NCT02393950|Secondary|Effect of ODM-106 on Growth Hormone Levels|Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.|Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.|Only timepoints 2 - 6h evaluated.|||ng/ml||Standard Deviation|Geometric Mean
1316359|NCT02393950|Secondary|Metabolite Screening in Plasma and Urine|Metabolite screening in plasma and urine after single dosing|Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level|||||||
1316360|NCT02393950|Secondary|Elimination Half-life of ODM-106|Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.||||h||Standard Deviation|Mean
1316361|NCT02393950|Secondary|Time to Peak Plasma Concentration (Tmax) of ODM-106|tmax of ODM-106 after single oral dosing of Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level||||h||Full Range|Mean
1316362|NCT02393950|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106|AUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level||||h*ng/ml||Standard Deviation|Mean
1316363|NCT02393950|Secondary|Peak Plasma Concentration (cMax) of ODM-106|cMax of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.||||ng/ml||Standard Deviation|Mean
1316364|NCT02393950|Primary|Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.|Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.|From screening up to 16 weeks||||subjects affected|||Number
1316365|NCT02393677|Other Pre-specified|Complications||2 hours|||||||
1316366|NCT02393677|Other Pre-specified|Haemodynamic Changes||8 hours|||||||
1316367|NCT02393677|Secondary|Duration of Motor Block||6 hours|||||||
1316368|NCT02393677|Secondary|Onset of Motor Block||30minutes|||||||
1316369|NCT02393677|Secondary|Onset of Sensory Block||20 minutes|||||||
1316370|NCT02393677|Primary|Duration of Analgesia||upto 8 hours||||minutes||Standard Deviation|Mean
1316384|NCT02393209|Secondary|Time to Progression in Phase 2|Time to progression is defined as the time from the date of randomization to the date of first documentation of progression of disease. As per RECIST 1.1, PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
1316385|NCT02393209|Secondary|Duration of Response in Phase 2|The duration of response is defined as the time from the date of first documentation of a response to the date of first documentation of progression of disease. As per RECIST 1.1, PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
1316386|NCT02393209|Secondary|Disease Control Rate in Phase 2|Disease control rate is defined as percentage of participants with CR + PR + stable disease (SD). According to RECIST: CR is defined as disappearance of all target lesions, PR is defined as 30% decrease in the sum of the longest diameter of target lesions and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
1316387|NCT02393209|Secondary|Response Rate in Phase 2|Response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
1316388|NCT02393209|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 2|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Approximately 12 months in Phase 2|Safety population was defined as all participants who received at least 1 dose of any study drug.||||||
1316389|NCT02393209|Secondary|Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as Adverse Events in Phase 2|The number of participants with any markedly abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout study.|Approximately 12 months in Phase 2|Safety population was defined as all participants who received at least 1 dose of any study drug.||||||
1316390|NCT02393209|Secondary|Number of Participants With Electrocardiogram (ECG) Findings Reported as Adverse Events in Phase 2|Clinically significant changes from baseline in ECGs will be tabulated by time point including any unscheduled measurements.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of study was cancelled.||||||
1316391|NCT02393209|Secondary|Number of Participants With Significant Change in Physical Examination Reported as Adverse Events in Phase 2|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of study was cancelled.||||||
1316392|NCT02393209|Secondary|Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 2|Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of study was cancelled.||||||
1316393|NCT02393209|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug to 30 days after last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1316394|NCT02393209|Secondary|Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as Adverse Events in Phase 1b|The number of participants with any markedly abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout study.|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1316395|NCT02393209|Secondary|Number of Participants With Electrocardiogram (ECG) Findings Reported as Adverse Events in Phase 1b|A standard 12-lead ECG was performed.|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1316408|NCT02392767|Secondary|Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.|The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.|Intervention period of 4 weeks||||mmHg||95% Confidence Interval|Mean
1316396|NCT02393209|Secondary|Number of Participants With Significant Change in Physical Examination Reported as Adverse Events in Phase 1b|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1316397|NCT02393209|Secondary|Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 1b|Clinically significant change from baseline in vital sign measures will be assessed. Vital sign measurements included measurements of diastolic and systolic blood pressure, heart rate, and temperature.|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1316398|NCT02393209|Primary|Progression-Free Survival (PFS) in Phase 2|PFS is defined as the time from the date randomization to the date of first documented progressive disease (PD) or death as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
1316399|NCT02393209|Primary|Recommended Phase 2 Dose of TAK-117 in Phase 1b|The recommended phase 2 dose was determined in Phase 1b based on participant dose-limiting toxicities and the maximum tolerated dose.|Cycle 1 (Up to Day 21)|The DLT-evaluable population was defined as all participants who either experienced DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of TAK-117 plus docetaxel and have sufficient follow-up data to allow investigators and sponsor to determine whether DLT occurred.|||mg|||Number
1316400|NCT02393209|Primary|Maximum Tolerated Dose (MTD) of TAK-117 in Combination With Docetaxel 36 mg/m^2 in Phase 1b|The MTD is defined as the dose of TAK-117 in combination with docetaxel 36 mg/m^2 at which 1 of 6 evaluable participants experience DLT. DLT was evaluated according to NCI CTCAE version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.|Cycle 1 (Up to Day 21)|The DLT-evaluable population was defined as all participants who either experienced DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of TAK-117 plus docetaxel and have sufficient follow-up data to allow investigators and sponsor to determine whether DLT occurred.|||mg|||Number
1316401|NCT02393209|Primary|Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1b|DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.|Cycle 1 (Up to Day 21)|The DLT-evaluable population was defined as all participants who either experienced DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of TAK-117 plus docetaxel and have sufficient follow-up data to allow investigators and sponsor to determine whether DLT occurred.|||participants|||Number
1316402|NCT02392806|Secondary|Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly|Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours|96 hours||||Participants|||Count of Participants
1316403|NCT02392806|Primary|Number of Participants With Extubation Failure|Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation|Within 72 hours of extubation||||Participants|||Count of Participants
1316404|NCT02392767|Other Pre-specified|Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase|"Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the percentage of the standard Quick value. In a person not receiving oral anticoagulation the normal Quick value is between 70 and 100%. The longer the patient's coagulation time, the lower the Quick value"|Intervention period of 4 weeks||||Percentage of the standard Quick value||95% Confidence Interval|Mean
1316405|NCT02392767|Secondary|Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.|Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.|After intervention period of 4 weeks||||percentage of total hemoglobin||95% Confidence Interval|Mean
1316406|NCT02392767|Secondary|Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.|ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test|After intervention period of 4 weeks||||µmol/l||95% Confidence Interval|Mean
1316407|NCT02392767|Secondary|Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.|"Homocystein level in µmol/l was determined on the final day of the 4 week intervention period.~The first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)"|After intervention period of 4 weeks||||μmol/l||95% Confidence Interval|Mean
1316409|NCT02392767|Primary|"Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta lnRHI)"|"Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index (lnRHI) which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side.~Normal lnRHI > 0.51, Abnormal lnRHI < 0.51"|Intervention period of 4 weeks||||Delta lnRHI [Index]||95% Confidence Interval|Mean
1316410|NCT02392624|Secondary|Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score indicates improvement.|At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)|Analysis was performed on participants in mITT population who were randomized to placebo arm and who were retreated with open-label omalizumab after randomization. Here, ‘Number Analyzed’ signifies number of participants with available data for this outcome at specified time-point.|||units on a scale||Standard Deviation|Mean
1316411|NCT02392624|Secondary|Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score (Week 48 score minus Week 24 score) indicates improvement.|Week 24 (randomization) and Week 48|Analysis was performed on participants in mITT population who received total 48 weeks of treatment with omalizumab. If UAS7 data was missing, last observation carry forward (LOCF) method was used post-Week 24 for the closest non-missing UAS7 data up to Week 48.|||units on a scale||Standard Deviation|Mean
1316412|NCT02392624|Secondary|Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48.|From randomization (Week 24) to Week 48|Analysis was performed on mITT population.|||percentage of participants||95% Confidence Interval|Number
1316413|NCT02392624|Secondary|Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From randomization (Week 24) to Week 48|Analysis was performed on mITT population.|||weeks||95% Confidence Interval|Median
1316414|NCT02392624|Primary|Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks)|Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48.|From randomization (Week 24) to Week 48|Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of blinded study drug, and achieved one post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1316415|NCT02392481|Secondary|Level of Interleukin-6 (IL-6) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)|Level of Interleukin-6 (IL-6) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.|follow-up visit 28 days after baseline (Visit 2)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
1316416|NCT02392481|Secondary|Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)|Level of Tumour Necrosis Factor-alpha (TNF-α) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.|follow-up visit 28 days after baseline (Visit 2)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
1329604|NCT02107014|Primary|Change in IL-23 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1316417|NCT02392481|Primary|Level of Interleukin-6 (IL-6) in Blood at Baseline (Visit 1)|Level of Interleukin-6 (IL-6) (pg/mL) in blood at baseline (Visit 1) is presented.|Baseline (Visit 1)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
1316418|NCT02392481|Primary|Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)|Level of Tumour Necrosis Factor-alpha (TNF-α) [picograms per milliliter (pg/mL)] in blood at baseline (Visit 1) is presented.|Baseline (Visit 1)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
1316419|NCT02392377|Secondary|Occurrence of Grade 3 or 4 Toxicity Per the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0|Toxicities will be summarized as the percentage of patients experiencing each type and grade of event according to treatment group. Patients who receive at least one dose of treatment will be included in the analysis.|Up to 30 days after the end of treatment|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316420|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction microRNA Levels/Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Changes in baseline and post-treatment microRNA level/profiles will be compared between 8 pathologic responders vs. 17 patients not achieving a pathologic complete response per treatment regimen, filtering for expression levels changes of 0.20 and above. Differences in expression level changes per treatment regimen will be calculated using a t-test. Top microRNAs will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316421|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction Gene Expression Levels/Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Changes in baseline and post-treatment gene expression level/profiles will be compared between 8 pathologic responders vs. 17 patients not achieving a pathologic complete response per treatment regimen, filtering for expression levels changes of 0.20 and above. Differences in expression level changes per treatment regimen will be calculated using a t-test. Top genes will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316422|NCT02392377|Secondary|Relative Expression Differences in Baseline Individual microRNAs and microRNA Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Baseline microRNA profiles for 8 pathologic complete responders vs. 17 patients not achieving a pathologic complete response per treatment regimen using a t-test will be compared. Top microRNAs will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316423|NCT02392377|Secondary|Relative Expression Differences in Baseline Individual Genes and Gene Expression Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Baseline gene expression profiles for 8 pathologic complete responders vs. 17 patients not achieving a pathologic complete response per treatment regimen using a t-test will be compared. Top genes will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316424|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction Chemotherapy Specimens of Individual microRNAs and microRNA Profiles|Changes in baseline and post-treatment microRNA levels will be calculated between (18F) FDG-PET responders and non-responders, filtering for expression level changes of >= 0.20. Differences in expression level change per treatment regimen will be calculated using a t-test and p-values will be corrected for multiple comparisons by calculating FDR p-value (filtering on a FDR p-value < 0.05). Top microRNAs identified will be tested in combination for their sensitivity and specificity using logistic regression models to predict responsiveness or resistance to each individual treatment regimen.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316425|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction Chemotherapy Specimens of Individual Genes and Gene Expression Profiles|Changes in baseline and post-treatment gene expression levels will be calculated between (18F) FDG-PET responders and non-responders, filtering for expression level changes of >= 0.20. Differences in expression level change per treatment regimen will be calculated using a t-test and p-values will be corrected for multiple comparisons by calculating FDR p-value (filtering on a FDR p-value < 0.05). Top genes identified will be tested in combination for their sensitivity and specificity using logistic regression models to predict responsiveness or resistance to each individual treatment regimen.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316426|NCT02392377|Primary|Biological Pathway Perturbation Upon Exposure to Chemotherapy|Predefined signatures of biological pathway activities will be evaluated in order to identify pathway perturbation upon exposure to chemotherapy. Significant pathway modulations upon brief exposure will then be evaluated for association with clinical response using non-parametric tests such as the Wilcoxon signed-rank test. In all cases, statistical correction to account for multiple hypothesis testing will be employed and pathways with a false discovery rate of 10% or lower will be considered as significant.|Up to 6 weeks|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316427|NCT02392377|Primary|Relative Expression Differences in Individual microRNAs and microRNA Profiles Between Patients Responding and Not Responding to Treatment, Assessed by (18F) FDG-PET|Baseline microRNA profiles will be compared for 10 (18F) FDG-PET responders vs. 15 (18F) FDG-PET non-responders per treatment regimen using a t-test and p-values will be corrected for multiple comparisons by calculating the FDR p-value (filtering on a FDR p-value < 0.05). Top microRNAs identified will be tested in combination for their sensitivity and specificity using logistic regression models.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316428|NCT02392377|Primary|Relative Expression Differences in Individual Genes and Gene Profiles Between Patients Responding and Not Responding to Treatment, as Assessed by (18F) FDG-PET|Baseline gene profiles will be compared for 10 (18F) FDG-PET responders vs. 15 (18F) FDG-PET non-responders per treatment regimen using a t-test and p-values will be corrected for multiple comparisons by calculating the false discovery rate (FDR) p-value (filtering on a FDR p-value < 0.05). Top genes identified will be tested in combination for their sensitivity and specificity using logistic regression models.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
1316429|NCT02392247|Primary|Clot Stiffness|Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) for each patient at each of 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU]|||hPa|Participants|Standard Deviation|Mean
1316430|NCT02392247|Primary|Clot Time|Coagulation Function assessed at 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU] over the course of cardiac surgery until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) obtained from each patient at each sampling time (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU)|||min|Participants|Standard Deviation|Mean
1316431|NCT02392234|Secondary|Ctrough of IVA and IVA Metabolite (M1 IVA) After Administration of IVA Monotherapy||Pre-morning dose on Week 8 of each treatment period|PK set was used. Here ‘Overall Number of participants analyzed’ signifies those participants who had evaluable data for this outcome measure.|||ng/mL||Standard Deviation|Mean
1316432|NCT02392234|Secondary|Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolites (M1 VX-661), IVA and IVA Metabolite (M1 IVA) After Administration of VX-661/IVA Combination Therapy||Pre-morning dose on Week 8 of each treatment period|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1316433|NCT02392234|Secondary|Absolute Change From Study Baseline in Sweat Chloride at Average of Week 4 and Week 8||Baseline, Week 4 and Week 8 of each treatment period|FAS was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1316434|NCT02392234|Secondary|Relative Change From Study Baseline in ppFEV1 at Average of Week 4 and Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Week 4 and Week 8 of each treatment period|FAS was used. Here ‘Overall Number of participants analyzed’ signifies those participants who had evaluable data for this outcome measure.|||percent change||95% Confidence Interval|Least Squares Mean
1316435|NCT02392234|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Week 28|Safety Set included all participants who received at least 1 dose of study drug.|||participants|||Number
1316436|NCT02392234|Secondary|Absolute Change From Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Average of Week 4 and Week 8|The CFQ-R assessed respiratory symptoms on a scale with scores ranging from 0 to 100; where higher scores indicated fewer symptoms and better health-related quality of life.|Baseline, Week 4 and Week 8 of each treatment period|FAS was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316437|NCT02392234|Primary|Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Week 4 and Week 8 of each treatment period|Full Analysis Set (FAS) included all randomized participants who carry the protocol specified cystic fibrosis transmembrane conductance regulator gene (CFTR) mutations and had received at least 1 dose of study drug. Here ‘Overall Number of participants analyzed’ signifies those participants who had evaluable data for this outcome measure.|||percentage of predicted FEV1||95% Confidence Interval|Least Squares Mean
1316438|NCT02392208|Secondary|AUC24-48 of Telavancin|Area under the telavancin concentration-time curve 24-48 hours from start of infusion|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mcg*h/mL||Standard Deviation|Mean
1316439|NCT02392208|Secondary|AUC0-24 of Telavancin|Area under the telavancin concentration-time curve 0-24 hours from start of infusion|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mcg*h/mL||Standard Deviation|Mean
1316440|NCT02392208|Primary|t1/2 of Telavancin|Half-life of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||hours||Standard Deviation|Mean
1316441|NCT02392208|Primary|CLobs of Telavancin|Observed clearance of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mL/h/kg||Standard Deviation|Mean
1316442|NCT02392208|Primary|Vss of Telavancin|Volume of distribution of telavancin at steady state|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mL/kg||Standard Deviation|Mean
1316443|NCT02392208|Primary|Cmax of Telavancin|Peak concentration of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mcg/mL||Standard Deviation|Mean
1316611|NCT02388347|Secondary|Terminal Phase Elimination Half Life (T1/2) of MEDI7836|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||day||Standard Deviation|Mean
1316444|NCT02392000|Secondary|Functional Outcomes of Sleep Score|Validated self-report short-form (10 item) measure of Functional Outcomes of Sleep-10 (FOSQ-10). The minimum FOSQ score is 5, the maximum score is 20, and higher scores indicate better functioning. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).|Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.|||units on a scale||Standard Deviation|Mean
1316445|NCT02392000|Secondary|Pittsburgh Sleep Quality Index (PSQI) Total Score|Validated self-report measure of self-reported sleep quality. The minimum PSQI Total scale score is 0, the maximum scale score is 21 and higher scale scores indicate worse subjective sleep quality. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).|Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.|||units on a scale||Standard Deviation|Mean
1316446|NCT02392000|Secondary|Insomnia Severity Index Score|Validated self-report measure of Insomnia Symptom Severity (ISI). The minimum ISI scale score is 0, the maximum scale score is 28, and higher scores indicate worse insomnia. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).|Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.|||units on a scale||Standard Deviation|Mean
1316447|NCT02392000|Primary|Number of Participants Using CBT-I Coach|CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data.|Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)|Those completing enrollment and not withdrawn by study personnel for insomnia were counted at Week 0. The Week 0 outcome measure is the number of participants who used sleep diaries in the CBT-I Coach for 5 or more nights of Week 0. In Week 6 it is the number of participants who used the CBT-I Coach for 5 or more nights during the sixth week.|||Participants|||Count of Participants
1316448|NCT02392000|Primary|Number of Participants Using WatchPAT|Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6.|Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are those whose data are used for Week 0.|||Participants|||Count of Participants
1316449|NCT02391714|Secondary|Baseline Mean Pain Scores|Baseline pain scores prior to IUD insertion is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|Before the IUD insertion procedure||||units on a scale||Standard Deviation|Mean
1316450|NCT02391714|Secondary|Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS|Satisfaction will be measured using a 100mm Visual Analog Scale (VAS), with anchors 0mm for very satisfied and 100mm for very dissatisfied.|Prior to clinic discharge, which is an average of 15 minutes after the procedure||||units on a scale||Standard Deviation|Mean
1316451|NCT02391714|Primary|Mean Maximum Procedural Pain Scores|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|2 minutes after the procedure.||||units on a scale||Standard Deviation|Mean
1316452|NCT02391311|Secondary|Change in Driving Simulator Performance|Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.|baseline, 6 week posttest|While n=33 was the final sample used for the primary outcome analyses, n=30 was used for the secondary outcome as 3 subjects did not have available simulator data.|||Times crossing center lane||95% Confidence Interval|Mean
1316453|NCT02391311|Primary|Change in the Processing of Speed|Computerized and paper & pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.|baseline, 6 week posttest|n=33 subjects were included in final analyses. Of the 37 that completed the study, 4 were deemed ineligible after they had completed the study due to confirmation with medical records they had conditions that may affect neurocognition (stroke and schizophrenia) although they self reported on the screen they did not have these conditions.|||units on a scale||Full Range|Mean
1316466|NCT02391116|Secondary|PFS by DLBCL/COO Subtype|The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
1316454|NCT02391116|Other Pre-specified|ORR by DLBCL/COO Subtype Based on Central Imaging Review|The objective response rate (ORR) was defined as the proportion of patients who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.|From start of study treatment assessed up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS)|||Percentage of Participants||90% Confidence Interval|Number
1316455|NCT02391116|Other Pre-specified|ORR by CD79b Status Based on Central Imaging Review|The objective response rate (ORR) was defined as the proportion of patients who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.|From start of study treatment assessed up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS)|||Percentage of Participants||90% Confidence Interval|Number
1316456|NCT02391116|Other Pre-specified|ORR in Total Population Based on Central Imaging Review|The objective response rate (ORR) was defined as the proportion of patients who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.|From start of study treatment assessed up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set|||Percentage of Participants||90% Confidence Interval|Number
1316457|NCT02391116|Other Pre-specified|Time to Response (TTR) in Total Population|The time to response (TTR) was defined as the time (days) from start of study treatment to the date of first observed response (first measured CR or PR). TTR was defined for responders only (i.e. patients with CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Responders (i.e. patients with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
1316458|NCT02391116|Secondary|Number of Patients With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application.|From start of study treatment to 30 days after termination of study drug, assessed up to 2 years after the last patient’s first treatment or the last patient dies (whichever occurs first ), with an average of 15 weeks for individual patient|Safety analysis set (SAF)|||Participants|||Number
1316459|NCT02391116|Secondary|DCR by DLBCL/COO Subtype|The disease control rate (DCR) was defined as the proportion of patients who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Percentage of Participants||90% Confidence Interval|Number
1316460|NCT02391116|Secondary|DCR by CD79b Status|The disease control rate (DCR) was defined as the proportion of patients who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Percentage of Participants||90% Confidence Interval|Number
1316461|NCT02391116|Secondary|Disease Control Rate (DCR) in Total Population|The disease control rate (DCR) was defined as the proportion of patients who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Percentage of Participants||90% Confidence Interval|Number
1316462|NCT02391116|Secondary|Duration of Stable Disease (DOSD) in Total Population|The duration of stable disease (DOSD) was defined as the time (in days) from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier. The DOSD was only evaluated in patients failing to achieve a best response of CR or PR, but who achieved SD (stable disease), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Patients who failed to achieve CR or PR but achieved SD in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
1316463|NCT02391116|Secondary|OS by DLBCL/COO Subtype|The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
1316464|NCT02391116|Secondary|OS by CD79b Status|The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
1316465|NCT02391116|Secondary|Overall Survival (OS) in Total Population|The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
1316467|NCT02391116|Secondary|PFS by CD79b Status|The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
1316468|NCT02391116|Secondary|Progression-free Survival (PFS) in Total Population|The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
1316469|NCT02391116|Secondary|DOR by DLBCL/COO Subtype|The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. patients with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Responders (i.e. patients with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
1316470|NCT02391116|Secondary|DOR by CD79b Status|The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. patients with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Responders (i.e. patients with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
1316471|NCT02391116|Secondary|Duration of Response (DOR) in Total Population|The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. patients with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last patient’s first treatment or the last patient dies, whichever occurs first|Responders (i.e. patients with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
1316472|NCT02391116|Primary|ORR by DLBCL/COO Subtype Based on Investigator Assessment|The objective response rate (ORR) was defined as the proportion of patients who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.|From start of study treatment assessed up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment (about 12 months)|Per protocol set (PPS)|||Percentage of Participants||90% Confidence Interval|Number
1316473|NCT02391116|Primary|ORR by CD79b Status Based on Investigator Assessment|The objective response rate (ORR) was defined as the proportion of patients who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.|From start of study treatment assessed up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment (about 12 months)|Per protocol set (PPS)|||Percentage of Participants||90% Confidence Interval|Number
1316474|NCT02391116|Primary|ORR in Total Population Based on Investigator Assessment|The objective response rate (ORR) was defined as the proportion of patients who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.|From start of study treatment assessed up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS)|||Percentage of Participants||90% Confidence Interval|Number
1316475|NCT02391116|Primary|Objective Response Rate (ORR) in Total Population Based on Investigator Assessment|The objective response rate (ORR) was defined as the proportion of patients who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.|From start of study treatment assessed up to 24 weeks after the last patient fully evaluable for the primary endpoint started treatment (about 12 months)|Per protocol set (PPS)|||Percentage of Participants||90% Confidence Interval|Number
1316476|NCT02391038|Secondary|Phase 2- Number of Participants With ATA in Serum|Blood samples were to be collected predose to evaluate ATA.|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316486|NCT02391038|Secondary|Phase 2- Percentage of Participants Who Experience at Least One SAE||Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1329605|NCT02107014|Primary|Change in IL-21 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1316477|NCT02391038|Secondary|Phase 2- Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors. The score is obtained by the formula: 3 * percentage of strongly staining nuclei + 2 * percentage of moderately staining nuclei + percentage of weakly staining nuclei, giving a range of 0 to 300. The 600 H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316478|NCT02391038|Secondary|Phase 2- Tumor Size Reduction|For each participant, the best percentage of tumor reduction from baseline in the sum of the diameter was calculated.|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316479|NCT02391038|Secondary|Phase 2- Plasma Concentration of MLN0264||Day 1 of every cycle (up to 1 year): predose and at multiple time points(up to 336 hours) post-dose|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316480|NCT02391038|Secondary|Phase 2- Overall Survival (OS)|OS is defined as the time from the date of first study drug administration to the date of death. Participants without documentation of death at the time of analysis were censored at the date when they were last known to be alive.|Baseline up to EOT thereafter every 12 weeks until death or the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316481|NCT02391038|Secondary|Phase 2- Disease Control Rate (DCR)|DCR is defined as Complete Response (CR) rate + Partial Response (PR) rate + stable disease (SD) rate with a minimum of 12 weeks' duration. Duration of SD is defined as the time from the date of first study drug administration to the date of first documentation of disease progression for participants who achieved SD as the best overall response. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Phase 2: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316482|NCT02391038|Secondary|Phase 2- Duration of Response (DOR)|DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documentation of Progressive Disease (PD). Responders without documentation of PD were censored at the last response assessment that was stable disease or better. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD and PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions.|Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316483|NCT02391038|Secondary|Phase 2- Progression-free Survival (PFS)|PFS is defined as the time from the date of first study drug administration to the date of first documentation of progressive disease or death. For a participant who has not progressed and is last known to be alive, PFS was censored at the last response assessment that was stable disease or better. PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions.|Baseline up to EOT, thereafter every 12 weeks until the occurrence of PD, the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316484|NCT02391038|Secondary|Phase 2- Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]).|Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316485|NCT02391038|Secondary|Phase 2- Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation.|Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316487|NCT02391038|Secondary|Phase 2- Percentage of Participants Who Experience at Least One TEAE||Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316488|NCT02391038|Secondary|Phase 1- Disease Response Based on the Investigator’s Assessment|Disease response was based on the investigator’s assessment using the modified RECIST version 1.1 guidelines. Evaluation of target lesions included CR (Disappearance of all target lesions),PR(at least a 30% decrease in the sum of the LD of target lesions),Progressive disease (PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and Stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).Evaluation of Non target Lesions included CR (disappearance of all non target lesions and normalization of tumor marker level), Incomplete response/SD (Persistence of 1 or more non target lesions and/or maintenance of tumor marker level above the normal limits) and PD(Appearance of 1 or more new lesions and/or unequivocal progression of existing non target lesions).|Phase 1: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to End of treatment (EOT) (Cycle10 or week 30)|The Response-Evaluable population is defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 post baseline response assessment.|||participants|||Number
1316489|NCT02391038|Secondary|Phase 1- Number of Participants With Antitherapeutic Antibodies (ATAs)|Blood samples was collected predose to evaluate ATA. Data was collected only for limited period due to early termination of the study.|Day 1 of Cycle 1, 2, 3, 4: predose|Safety population included all participants who received any amount of study drug.|||participants|||Number
1316490|NCT02391038|Primary|Phase 2- Overall Response Rate|ORR is the percentage of participants with complete response [CR] + partial response [PR]) based on modified Response Evaluation Criteria in Solid Tumors (RECIST). Overall response rate (CR + PR) based on modified RECIST version 1.1 guidelines. CR: Disappearance of all target lesions and PR: at least a 30 percentage (%) decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total representative of all involved organs were identified as target lesions at baseline. Target lesions were selected on the basis of size (longest lesions) and suitability for reproducible repeated measurements.|Baseline until end of study treatment (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
1316491|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
1316492|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||ng/mL||Standard Deviation|Geometric Mean
1316493|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*ng/mL||Standard Deviation|Geometric Mean
1316494|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*ng/mL||Standard Deviation|Geometric Mean
1316495|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*ng/mL||Standard Deviation|Geometric Mean
1316496|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*ng/mL||Standard Deviation|Geometric Mean
1316497|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||day||Full Range|Median
1316498|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters.|||day||Full Range|Median
1316499|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||ng/mL||Standard Deviation|Geometric Mean
1316500|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1316501|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||mcg/mL||Standard Deviation|Geometric Mean
1316502|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||mcg/mL||Standard Deviation|Geometric Mean
1316503|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316504|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316505|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316506|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316507|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||day||Full Range|Median
1316508|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters.|||day||Full Range|Median
1316509|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Serum Concentration for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||mcg/mL||Standard Deviation|Geometric Mean
1316510|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb)||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters.|||mcg/mL||Standard Deviation|Geometric Mean
1316511|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure.|||mcg/mL||Standard Deviation|Geometric Mean
1316512|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.|||mcg/mL||Standard Deviation|Geometric Mean
1316833|NCT02380287|Primary|Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1320 Hours After the Single Subcutaneous Injection of BCD-085||57 days||||(ng/ml)*hour||Inter-Quartile Range|Median
1316513|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316514|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316515|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316516|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
1316517|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.|||day||Full Range|Median
1316518|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure.|||day||Full Range|Median
1316519|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.|||mcg/mL||Standard Deviation|Geometric Mean
1316520|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The Pharmacokinetic (PK) evaluable population included all participants who received greater than or equal to (>=1) dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure.|||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
1316521|NCT02391038|Primary|Phase 1- Recommended Phase 2 Dose (RP2D)|RP2D is maximum tolerated dose(MTD) in study Phase1.MTD was highest dose of MLN0264 given at which <=1 of 6 participants experienced DLTduring Cycle1 of Phase1.DLT=any event related to MLN0264:Grade 4 neutropenia ANC less than<500 cells mm^3;>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle>2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy.|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||mg/kg|||Number
1316522|NCT02391038|Primary|Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]).|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.|||participants|||Number
1316523|NCT02391038|Primary|Phase 1- Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation.|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.|||participants|||Number
1316533|NCT02390219|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; event does not necessarily have a causal relationship with treatment. This includes any newly occurring event/previous condition that has increased in severity/frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. TEAEs: AEs that started/ worsened on/after the start of study drug through the Safety Follow up Visit (4 weeks after the last dose of study drug). Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Day 1 up to Week 28|Safety Set included all participants who were exposed to any amount of study drug.|||Participants|||Count of Participants
1316524|NCT02391038|Primary|Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs)|Toxicity evaluated as per NationalCancerInstituteCommonTerminologyCriteria for AEs (NCI CTCAE),version 4.03.DLT=any event related to MLN0264:Grade 4 neutropenia(absolute neutrophil count[ANC]less than[<]500 cells/millimeter[mm]^3); >=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle greater than (>)2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy.|Phase 1: Up to Cycle 1 (3 weeks)|The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||participants|||Number
1316525|NCT02391038|Primary|Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE)||Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.|||participants|||Number
1316526|NCT02391038|Primary|Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks)|Safety population includes all participants who received any amount of study drug.|||participants|||Number
1316527|NCT02390219|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Units on a scale||Standard Error|Least Squares Mean
1316528|NCT02390219|Secondary|Absolute Change From Baseline in Sweat Chloride at Average of Day 15 and Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. The average absolute change from baseline in sweat chloride was derived as: (Average of Day 15 and Week 4 value) minus Baseline value. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Day 15 and Week 4|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Millimoles per litre (mmol/L)||Standard Error|Mean
1316529|NCT02390219|Secondary|Number of Hospitalizations|Number of hospitalizations (all causes) through Week 24 was summarized. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Hospitalizations|||Number
1316530|NCT02390219|Secondary|Duration For Which Participants Received Intravenous (IV) Antibiotics|The duration for which participants received IV antibiotics for sinopulmonary signs and symptoms were reported. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who received at least one IV antibiotic for sinopulmonary signs and symptoms."|||Days||Standard Deviation|Mean
1316531|NCT02390219|Secondary|Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Up to Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Up to Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Liter (L)||Standard Error|Least Squares Mean
1316532|NCT02390219|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Up to Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Up to Week 24|"Full Analysis Set (FAS) included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percent predicted of FEV1||Standard Error|Least Squares Mean
1316534|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method|Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).|1 hour|366 (375-9) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol.|||Percent of Results within 15mg/dL/15%|||Number
1316535|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method|Untrained subject WITH and WITHOUT diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).|1 hour|372 (375 - 3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.|||Percent of Results within 15mg/dL/15%|||Number
1316536|NCT02390167|Secondary|Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose|Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.|1 hour||||Percent of Subjects who responded|||Number
1316537|NCT02390167|Secondary|Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.|1 hour||||Percent of Subjects who responded|||Number
1316538|NCT02390167|Secondary|Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.|1 hour||||Percent of Subjects who responded|||Number
1316539|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 12.5% (>=100 mg/dL YSI capillary plasma).|1 hour|329 (332-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.|||Percent of Results within12.5mg/dL/12.5%|||Number
1316540|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff|Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.|1 hour|375 Blood glucose results were analyzed.|||Percent of Results within 20%|||Number
1316541|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff|Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.|1 hour|375 Blood glucose results were analyzed.|||Percent of Results within 15%|||Number
1316542|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percent of Results within 20%|||Number
1316543|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percent of Results within 15%|||Number
1316544|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested Fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|372 (375-3) Blood glucose results were analyzed. Three subjects did not contain meter BG results after three attempts.|||Percent of Results within 20%|||Number
1316612|NCT02388347|Secondary|Apparent Systemic Clearance (CL/F) of MEDI7836|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||milliliter per day (mL/day)||Standard Deviation|Mean
1316545|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|372 (375-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.|||Percent of Results within 15%|||Number
1316546|NCT02390167|Secondary|Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI venous plasma) and +/- 15% (>=100 mg/dL YSI venous plasma).|1 hour|330 (332-2) Blood glucose results were analyzed. Two (2) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.|||Percent of Results within 15mg/dL/15%|||Number
1316547|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject (332 WITH diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|332 Blood glucose results from subjects with diabetes were analyzed.|||Percent of Results within 15mg/dL/15%|||Number
1316548|NCT02390167|Secondary|Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|318 (332 with diabetes -14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percent of Results within 15mg/dL/15%|||Number
1316549|NCT02390167|Primary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|329 (332 with diabetes-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.|||Percent of Results within 15mg/dL/15%|||Number
1316550|NCT02389881|Secondary|Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058|Area under the plasma concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval.|Day 10 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng*hr/mL||Standard Deviation|Mean
1316551|NCT02389881|Secondary|Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058|AUC24 is measure of area under the curve from time 0 to 24 hours postdose.|Day 1 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng*hr/mL||Standard Deviation|Mean
1316552|NCT02389881|Secondary|Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058|AUClast is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration.|Day 1 predose and at multiple time points (up to 72 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng*hr/mL||Standard Deviation|Mean
1316553|NCT02389881|Secondary|Mean Cmax: Maximum Observed Plasma Concentration for TAK-058|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng/mL||Standard Deviation|Mean
1316554|NCT02389881|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose|The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1316555|NCT02389881|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-Dose|The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1317279|NCT02368314|Primary|Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.|||participants|||Number
1316556|NCT02389881|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1316557|NCT02389829|Secondary|Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire|Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief.|48 hours after discharge from Emergency Department||||Participants|||Count of Participants
1316558|NCT02389829|Secondary|Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire|"Participants were asked to make evaluation of pain status since discharge. Those achieving headache level mild or none for 1 hour are considered to achieve short term headache relief."|48 hours after discharge from Emergency Department||||Participants|||Count of Participants
1316559|NCT02389829|Secondary|Number of Participants Needing Rescue Medication as Assessed by Questionnaire|Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication.|48 hours after discharge from Emergency Department||||Participants|||Count of Participants
1316560|NCT02389829|Primary|Number of Participants With Sustained Headache Relief Assessed by Self-evaluation|"Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours, without use of addition medication. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration."|up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department||||Participants|||Count of Participants
1316561|NCT02389452|Secondary|Change From Baseline in WOMAC C Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant’s ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.|||units on a scale||Standard Deviation|Mean
1316562|NCT02389452|Secondary|Change From Baseline in WOMAC B Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.|||units on a scale||Standard Deviation|Mean
1316563|NCT02389452|Secondary|Change From Baseline in WOMAC A Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.|||units on a scale||Standard Deviation|Mean
1316564|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.|||units on a scale||Standard Deviation|Mean
1316565|NCT02389452|Secondary|Time Between Initial and Repeat Synvisc-One Treatment|Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection.|Baseline up to Week 52|ITT population. Number of participants analysed = participants from ITT population who received repeat injection.|||weeks||Standard Deviation|Mean
1316566|NCT02389452|Secondary|Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported.|Baseline up to Week 52|ITT population. Number of participants analysed = participants with baseline and Week 52 data.|||participants|||Number
1316613|NCT02388347|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI7836|The Cmax is the maximum observed serum concentration of study drug.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1316567|NCT02389452|Secondary|12-Item Short Form Health Survey (SF-12)|SF-12 health survey is a self-reported questionnaire to measure participant’s profile of functional health and well–being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported.|Baseline, Week 26, 52|ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively.|||participants|||Number
1316568|NCT02389452|Secondary|Clinician Observer Global Assessment (COGA) Score at Week 52|COGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant’s osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF).|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||participants|||Number
1316569|NCT02389452|Secondary|Patient Global Assessment (PTGA) Score at Week 52|PTGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||participants|||Number
1316570|NCT02389452|Secondary|Change From Baseline in WOMAC C Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant’s ability to move around and perform usual activities of daily living.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
1316571|NCT02389452|Secondary|Change From Baseline in WOMAC B Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
1316572|NCT02389452|Secondary|Change From Baseline in WOMAC A Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
1316573|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
1316574|NCT02389452|Primary|Change From Baseline in WOMAC A1 Subscore at Week 26|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).|ITT population.|||units on a scale||Standard Deviation|Mean
1316575|NCT02389374|Secondary|Frequency and Type of Variants of the G6PD Gene Within the Study Population||day 0 or 1||2019-12-31|12/2019||||
1316576|NCT02389374|Secondary|The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients||day 0||||U/gHb||Inter-Quartile Range|Median
1316577|NCT02389374|Secondary|Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count||day 16||||Participants|||Count of Participants
1316578|NCT02389374|Secondary|Recurrence of Parasitaemia Within 16 Days of Follow up||day 16||||Recurrences of Parsitaemia|||Number
1316579|NCT02389374|Secondary|Proportion of Patients With Fever on Day 2 After Treatment||day 2||||Participants|||Count of Participants
1316580|NCT02389374|Secondary|Proportion of Patients With Any Parasitemia on Day 3 After Treatment||day 3||||participants|||Number
1316581|NCT02389374|Secondary|Proportion of Patients With Anaemia Less Than 8g/dl on Day 2||on day 2||||participants with Hb under 8g/dl|||Number
1316582|NCT02389374|Secondary|Fractional Change in Hb Between Baseline and Day 9 and 16||day 0 and 16||||percent change Hb||95% Confidence Interval|Mean
1316583|NCT02389374|Secondary|Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)||day 28||||participants|||Number
1316584|NCT02389374|Primary|The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment|The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28|during follow up (day 28)||||events|||Number
1316585|NCT02389361|Primary|Acute Pain|Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale.|In recovery room||||units on a scale||Standard Deviation|Median
1316586|NCT02389088|Primary|Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II|Testosterone, Androstenedione and 17-OH Progesterone (nmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||nmol/L||Standard Deviation|Mean
1316587|NCT02389088|Primary|LH and FSH During Phase I and Phase II|LH and FSH (IU/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||IU/L||Standard Deviation|Mean
1316588|NCT02389088|Primary|Inhibin B During Phase I and Phase II|Inhibin B (ng/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||ng/L||Standard Deviation|Mean
1316589|NCT02389088|Primary|Estradiol During Phase I and Phase II|Estradiol (pmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||pmol/L||Standard Deviation|Mean
1316590|NCT02388997|Post-Hoc|Time to Peak Airway Symptoms (Lower Respiratory Tract) Following Virus Inoculation.|Time to peak airway symptoms (lower respiratory tract) following virus inoculation was compared among the asthmatics in the omalizumab treatment arm compared to time to peak symptoms among those in the placebo treatment arm.|21 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||days||95% Confidence Interval|Geometric Mean
1316591|NCT02388997|Secondary|Number of Participants Whose FEV1 Dropped by More Than 20% During the Infection.|Number of participants whose FEV1 dropped by more than 20% during the infection compared to their FEV1 value at baseline at the time of enrollment.|21 days|Two participants in the omalizumab treatment arm had to be dropped according to protocol because 1 developed a positive qPCR test for rhinovirus 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||Participants|||Count of Participants
1316592|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the First 4 Days of the Acute Infection (Upper Respiratory Tract Symptoms).|This secondary outcome was based on the comparison of cumulative upper respiratory tract symptoms scores (CURTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 4 days of acute infection. The symptoms evaluated daily included runny nose, sneezing, nasal congestion, sore throat, headache, chills/fever, fatigue, itchy/watery eyes. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 48. The scores recorded daily could range from 0 to 48.|4 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
1316593|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the First 4 Days of the Acute Infection With Cough.|This secondary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, shortness of breath and cough. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 24. The scores recorded daily could range from 0 to 24.|4 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
1316594|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the 21 Days of Monitoring During the Infection.|This secondary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the 21 days of monitoring during the infection. The symptoms evaluated daily included wheeze, chest tightness, and shortness of breath. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|21 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
1316609|NCT02388347|Secondary|Apparent Terminal-Phase Volume of Distribution (Vz/F) of MEDI7836|The apparent volume of distribution of MEDI7836 after a single dose, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||mL||Standard Deviation|Mean
1316610|NCT02388347|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI7836|The Tmax is defined as actual sampling time to reach maximum observed MEDI7836 concentration.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||day||Full Range|Median
1316595|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the First 7 Days of the Acute Infection.|This secondary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 7 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, and shortness of breath. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|7 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
1316596|NCT02388997|Primary|Airway Symptom Scores Experienced by Participants During the First 4 Days of the Acute Infection.|The primary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, and shortness of breath. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|4 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
1316597|NCT02388815|Primary|Point Accuracy|"Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.~The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences.~Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100."|14 days|One subject withdrew prior to having a sensor applied, another did not perform any blood glucose tests on the FreeStyle Libre. Neither subject could be included in the accuracy analysis, both are included in the safety analysis.|||percentage of glucose results in zone A||95% Confidence Interval|Number
1316598|NCT02388776|Secondary|Predictive Value of ROTEM Data|To assess whether ROTEM abnormalities correlate with allogenic blood product administration by blinded ICU physicians|21 days|Only two subjects enrolled, one withdrawn early due to death and the second lost to follow up prior to the completion of the final ROTEM testing.||||||
1316599|NCT02388776|Primary|Coagulation Parameters|To compare ROTEM coagulation parameters involving fibrin contribution to clot formation (FIBTEM) between patients on admission/enrollment (day 1), and on days 2, 3, 5, 7, 14 and 21 after burn injury to see if expected hypercoagulability shows evidence of resolution.|21 days|Data not collected for two subjects for all time points for primary outcome due to subject being discharged from hospital and subject death.||||||
1316600|NCT02388763|Secondary|High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat Subjects|||VA unit||Standard Deviation|Mean
1316601|NCT02388763|Primary|High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat|||VA unit||Standard Deviation|Mean
1316602|NCT02388568|Secondary|Body Weight (% Change)|This is the change in weight from the baseline (screening visit) to the final week 52 medical assessment visit.|-14 week (start of LCD program) to week 52||||% change||Standard Error|Mean
1316603|NCT02388568|Secondary|Body Weight|This is the change in weight from baseline (screening visit) to the final week 52 medical assessment visit.|-14 week (start of LCD program) to week 52||||kg||Standard Error|Mean
1316604|NCT02388568|Secondary|Proportion Maintaining >= 10% Loss of Initial Weight|This is the number of participants who maintained >=10% loss of initial weight in the randomization to week 52 trial period.|52 weeks post-randomization||||Participants|||Count of Participants
1316605|NCT02388568|Secondary|Body Weight (% Change)|The % change in body weight from randomization to week 52.|52 weeks post-randomization||||% change||Standard Error|Mean
1316606|NCT02388568|Primary|Proportion Maintaining >= 5% Loss of Initial Weight|This is the number of participants who maintained >=5% loss of initial weight in the randomization to week 52 trial period.|52 weeks post-randomization||||Participants|||Count of Participants
1316607|NCT02388568|Primary|Change in Weight (kg)|This is the change in weight from randomization to week 52. This does not include the weight loss in the 14-week LCD.|52 weeks post-randomization||||kg||Standard Error|Mean
1316608|NCT02388347|Secondary|Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|Predose on Day 1 to 281 days Postdose|"As Treated Population included all randomized participants and treated with MEDI7836 or placebo. Here, n is number of participants analysed at given time point."|||Percentage of participant|||Number
1317710|NCT02357940|Primary|Percentage With Scaling on the Face at Day 7|Percentage of adults and babies with scaling on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1316614|NCT02388347|Secondary|Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836|Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 to the last quantifiable data point (AUC0-t).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||day*mcg/mL||Standard Deviation|Mean
1316615|NCT02388347|Secondary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836|Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|Pharmacokinetic (PK) Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||Day*microgram per milliliter||Standard Deviation|Mean
1316616|NCT02388347|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
1316617|NCT02388347|Primary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events|Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight. Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system. Criteria for abnormal physical findings was based on investigator's discretion. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
1316618|NCT02388347|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
1316619|NCT02388347|Primary|Number of Participants With Injection Site Reactions|Participants were evaluated for manifestations of injection site reactions.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
1316620|NCT02388347|Primary|Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
1316621|NCT02388321|Secondary|Adverse Events at 30 Minutes|The patient were asked at 30 minutes post administration of analgesia if they experienced any side effects like nausea, vomiting, headache etc.|30 minutes||||Participants|||Count of Participants
1316622|NCT02388321|Primary|Pain Score at 30 Minutes|An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia.|30 minutes||||units on a scale||Standard Deviation|Mean
1316623|NCT02388295|Other Pre-specified|Exploratory Efficacy: Unified Multiple System Atropy Rating Scale, Change From Baseline (Total Score, Part 1 + Part 2)|Exploratory efficacy: Unified Multiple System Atropy Rating Scale, change from baseline (total Score, Part 1 + Part 2) : Score range 0 to 104, positive value indicates worsening symptoms|Baseline to final treatment visit|Efficacy population: with baseline (Day -1) and post baseline assessment|||Score change from baseline||90% Confidence Interval|Least Squares Mean
1316624|NCT02388295|Secondary|Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity|Myeloperoxidase (MPO) inhibition in plasma (change from baseline), on samples collected and analyzed, specific activity (activity/protein)|Baseline (Day -1) and week 12|efficacy population, restricted to subjects with paired samples analyzed within 6 months of collection|||ratio||90% Confidence Interval|Least Squares Mean
1316625|NCT02388295|Primary|Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET)|Striatum Brain region: Change from baseline in microglia activation via PET By [11C]PBR28 binding to translocator protein|Baseline (pre randomization) and Week 12|PET analysis population (Paired baseline and week 12 PET scans)|||ml/cc||Standard Deviation|Mean
1316626|NCT02388269|Secondary|Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)|"Short-Form Leeds Dyspepsia Questionnaire (SFLDQ): Question 5: Most Troublesome Symptom.~In question five of the SFLDQ the subject reports which of the symptoms has been most troublesome to them, this is also reported for each of the study periods. (Note: results of questions 1-4 of the SFLDQ are reported separately in outcome measure 3.)"|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period||||Participants|||Count of Participants
1321217|NCT02274870|Secondary|Mean Plasma Bupivacaine Levels||48hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
1316628|NCT02388269|Secondary|Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System)|Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Intention To Treat (ITT)|||units on a scale||Standard Deviation|Mean
1316629|NCT02388269|Secondary|Use of Concomitant Medication (Intake and Dose) During the Course of the Study|Compare last 2 weeks in randomised period with the run-in period, comparison open label period to randomization period. Concomitant medications were recorded and the number of subjects taking one or more concomitant medications is compared in the active and shams groups for both Functional Dyspepsia and Irritable Bowel Syndrome cohorts during the run-in, randomized and open label periods.|Run-In (2 weeks) and Randomized (4 weeks)|Intent-to-Treat|||Participants|||Count of Participants
1316630|NCT02388269|Secondary|Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)|Compare last 2 weeks in randomized period with the run-in period; & compare open label period to randomization period using Short-Form Dyspepsia Questionnaire (SFLDQ).The SFLDQ is a validated, self-completed questionnaire that measures frequency and severity of dyspepsia. The questionnaire comprises of 5 questions, questions 1 to 4 are about the patients dyspeptic symptoms and question 5 is about the most troublesome symptom for the patient. Questions 1 to 4 comprise of two stems concerning 'frequency' (how often the subject has the symptom over the last 2 months) and 'severity' (how often has this symptom interfered with normal activities over the last 2 months). Subjects choose from: Not at all, less than monthly, between monthly & weekly, between weekly & daily, more than daily or no response. In question 5 the subject reports which symptoms has been most troublesome for each of the study periods. Results for Question 5 of the SFLDQ are reported separately in outcome measure 7.|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Intention to Treat|||Participants|||Count of Participants
1316631|NCT02388269|Secondary|Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)|"Compare Quality of Life in last 2 weeks in the randomized period with the run-in period, and compare of Quality of life in the open label period to randomization period using the Functional Digestive Disorder Quality of Life (FDDQL) questionnaire.~The Functional Digestive Disorder Quality of Life (FDDQL) questionnaire is designed to measure Quality of Like (QOL) in patients with Functional Dyspepsia (FD) or Irritable Bowel Syndrome (IBS). The questionnaire is composed of 43 items (questions) investigating 8 dimensions: Daily activities, Anxiety, Diet, Sleep, Discomfort, Health, Coping and Stress. For the 43 items, patients rate the impact of their condition over the 8 dimensions from 1-5, where 1 = Not at all, 2 = A little Bit, 3 = Moderately, 4= Quite a bit, and 5 = Extremely. The mean score of the 8 dimensions is shown in the outcome measure data table."|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Intention To Treat population (ITT)|||units on a scale||Standard Deviation|Mean
1316632|NCT02388269|Primary|Symptom Changes in Subjects With Functional Gastrointestinal Disorder (Functional Dyspepsia and Irritable Bowel Syndrome)|Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.|Last 2 weeks in the 4 week Randomized period|Intention To Treat population (ITT)|||units on a scale||Standard Deviation|Mean
1316633|NCT02388191|Secondary|Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Fifteen minutes after IUD insertion is complete||||units on a scale||Inter-Quartile Range|Median
1316634|NCT02388191|Secondary|Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Five minutes after IUD insertion is complete||||units on a scale||Inter-Quartile Range|Median
1316635|NCT02388191|Secondary|Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after uterine sounding||||units on a scale||Inter-Quartile Range|Median
1316636|NCT02388191|Secondary|Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after tenaculum is placed on cervix||||units on a scale||Inter-Quartile Range|Median
1316637|NCT02388191|Primary|Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)|"Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after IUD insertion is complete||||units on a scale||Inter-Quartile Range|Median
1316638|NCT02388074|Primary|Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants|"The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®.~Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed."|2 months|22 participants were evaluated by a cytopathologist. Of these 22, PAP-stained slides of 3 participants were unreadable, 14 participants had provided samples that were confirmed by PAP as inadequate and only 5 slides were confirmed by PAP as adequate deep lung sputum samples. These 5 samples were evaluated for the presence of RFCs.|||number of RFCs per participant||Standard Deviation|Mean
1316639|NCT02387996|Secondary|ORR Per Investigator by PD-L1 Expression Level|Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of Participants||95% Confidence Interval|Number
1316640|NCT02387996|Secondary|Objective Response Rate (ORR) Per Investigator|Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects.|from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of Participants||95% Confidence Interval|Number
1316641|NCT02387996|Secondary|OS by PD-L1 Expression Level|Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive. PD-L1 expression level = membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|From first dosing date to the date of death (approximately 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Months||95% Confidence Interval|Median
1316642|NCT02387996|Secondary|Overall Survival|Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive.|From first dosing date to the date of death (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||months||95% Confidence Interval|Median
1316643|NCT02387996|Secondary|PFS Per BIRC Assessment by PD-L1 Expression Level|PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. RECIST is the Response Evaluation Criteria in Solid Tumors PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||months||95% Confidence Interval|Median
1316644|NCT02387996|Secondary|Progression-Free Survival (PFS) Per BIRC Assessment|PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. RECIST = Response Evaluation Criteria in Solid Tumors|from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Months||95% Confidence Interval|Median
1316654|NCT02387983|Primary|Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of Posaconazole on Day 8|The ssAUC0-24hr was calculated to determine the mean plasma drug concentration in the Intensive and Sparse PK subgroup from immediately after dosing to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.|||hr*ng/mL||Standard Deviation|Mean
1316645|NCT02387996|Primary|ORR Per BIRC Assessment by PD-L1 Expression Level|Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of Participants||95% Confidence Interval|Number
1316646|NCT02387996|Primary|Objective Response Rate Per BIRC Assessment|Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee|From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of participants||95% Confidence Interval|Number
1316647|NCT02387983|Primary|Tmax of Posaconazole on Day 1|The Tmax was calculated in order to determine the time required to reach Cmax in the Immediate and Sparse PK subgroup on Day 1.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||Hours||Full Range|Median
1316648|NCT02387983|Primary|Cmin of Posaconazole on Day 1|The Cmin was calculated in order to determine the lowest measurable drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
1316649|NCT02387983|Primary|Cmax of Posaconazole on Day 1|The Cmax was calculated to determine the maximum plasma drug concentration up to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Immediate and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
1316650|NCT02387983|Primary|AUC0-24hr of Posaconazole on Day 1|The AUC0-24hr was calculated to determine the mean plasma drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||hr*ng/mL||Standard Deviation|Mean
1316651|NCT02387983|Primary|Time to Steady-state Maximum Concentration (ssTmax) of Posaconazole on Day 8|The ssTmax was calculated in order to determine the amount of time required to reach ssCmax in the Intensive and Sparse PK subgroup on Day 8.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||hr||Full Range|Median
1316652|NCT02387983|Primary|Steady-state Minimum Concentration (ssCmin) of Posaconazole on Day 8|The ssCmin was calculated in order to determine the lowest measurable drug concentration in the Intensive and Sparse PK subgroup up to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
1316653|NCT02387983|Primary|Steady-state Maximum Concentration (ssCmax) of Posaconazole on Day 8|The ssCmax was calculated in order to determine the maximum post-dose plasma drug concentration in the Intensive and Sparse PK subgroup on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
1316668|NCT02387710|Secondary|Arousal Threshold (Esophageal Pressure Swing)|The arousal threshold was quantified as the mean of all the nadir negative esophageal pressure swings immediately preceding an arousal at the end of an obstructive apnea or hypopnea during both placebo and tiagabine nights.|1 night||||cmH2O||Inter-Quartile Range|Median
1316655|NCT02387983|Primary|Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8|The ssCavg was calculated in order to determine the percentage of participants achieving the pharmacokinetic (PK) target of ssCavg >500 ng/mL on Day 8 when plasma drug levels had reached steady state.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.|||Percentage of Participants|||Number
1316656|NCT02387801|Secondary|Time to at Least a 2 Point Improvement on the PatGA Score|The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.|Baseline though Week 12|All randomized participants.|||Days||90% Confidence Interval|Median
1316657|NCT02387801|Secondary|Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.|Baseline, Week 12|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
1316658|NCT02387801|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA)|The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant’s hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction|Baseline, Week 12|All randomized participants.|||percentage of body surface area||Standard Error|Least Squares Mean
1316659|NCT02387801|Secondary|Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)|"The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “Not at all,” “A little,” A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of “Not relevant” which is scored as “0”. For all questions, if unanswered the question is scored as “0”. Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint."|Baseline, Week 12|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
1316660|NCT02387801|Secondary|Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score|The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint.|Baseline, Week 12|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
1316661|NCT02387801|Primary|Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score|The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis “today” from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.|Baseline through Week 12|All randomized participants.|||Days||90% Confidence Interval|Median
1316662|NCT02387749|Secondary|Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %|Blood tests before and after stem cells(90 days) transfusion and comparing the values in percent % which is reflecting the patient blood sugar control in the previous 3 months|at base line (zero day) and 90 days after stem cells transfusion||||percent %||Standard Deviation|Mean
1316663|NCT02387749|Secondary|Change of Levels of Fasting Blood Sugar and 2 Hours Post Prandial at Base Line ( Zero Day ) and After (90 Days) After Stem Cells Transfusion|fasting, 2 hours postprandial blood sugar measurement before at base line (zero day) and after (90 days) stem cells transfusion as a follow up and comparing the values.|base line (zero day) and 90 days after stem cells transfusion||||mg/dl||Standard Deviation|Mean
1316664|NCT02387749|Primary|Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.|"Measuring nerve conduction amplitudes in uv of upper and lower limbs nerves(sensory and motor).~lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory .~upper limb nerves: ulnar nerve as motor and sensory. and compare at base line and 90 days after stem cells transfusion"|base line(zero dya), 90 days after stem cells transfusion||||uv||Standard Deviation|Mean
1316665|NCT02387749|Primary|Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study|Measuring nerve conduction latency in msec of upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line and 90 days after stem cells transfusion|base line(zero dya), 90 days after stem cells transfusion .||||msec||Standard Deviation|Mean
1316666|NCT02387749|Primary|Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.|Measuring nerve conduction velocities(NCV) in m/sec upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line(zero day) and 90 days after stem cells transfusion|base line(zero dya), 90 days after stem cells transfusion.||||m/sec||Standard Deviation|Mean
1316667|NCT02387749|Primary|Measurement of b-FGF, v-EGF MEASURED BY ELISA|measurement of b-FGF and v-EGF MEASURED BY ELISA before (at zero), and after at (7 days, 90) days after stem cell transfusion to measure the effect of stem cell and its role in nerve regeneration|zero ( before) , 7 DAYS, 90 days|b-FGF, V-EGF (pg/ml) measured at zero, 7 days after stem cell transfusion measured by ELISA to measure the effectiveness of stem cells and as an indication for nerve regeneration|||pg/ml||Standard Deviation|Mean
1316671|NCT02387580|Primary|Piperaquine AUC(0–168 h)|PQP Area under the plasma concentration versus time curve|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1316672|NCT02387580|Primary|Piperaquine Cmax|Piperaquine Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1316673|NCT02387580|Primary|OZ439 AUC(0–168 h)|OZ439 Area under the plasma concentration (AUC) versus time curve|pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1316674|NCT02387580|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1316675|NCT02387554|Other Pre-specified|Number of Paticipants With Adverse Events||3 months|||||||
1316676|NCT02387554|Secondary|Vz/F|Vz/F(Apparent volume of distribution)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
1316677|NCT02387554|Secondary|CL/F|CL/F(Apparent clearance)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
1316678|NCT02387554|Secondary|T1/2|T1/2(Terminal elimination half-life),|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
1316679|NCT02387554|Secondary|Tmax|Tmax(Time to maximum concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
1316680|NCT02387554|Secondary|AUCinf|AUCinf(Area under the curve to infinity)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
1316681|NCT02387554|Primary|Cmax|Cmax(maxium concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
1316682|NCT02387554|Primary|AUClast|AUClast(Area under the curve to the last measurable concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||Ratio(Comb/Alone)||90% Confidence Interval|Geometric Mean
1316683|NCT02387502|Primary|Time of Intubation|Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.|up to 10 minutes||||seconds||Standard Deviation|Mean
1316684|NCT02387476|Secondary|REM (Min)|The exact function of the REM is uncertain. However, it occupies approximately 25% of the total sleep time. REM sleep cycles occur every 90 to 120 min throughout the night with progressively increasing periods of time. REM sleep is associated with more frequent and longer duration apneas, hypopneas, and severe hypoxemia|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
1316685|NCT02387476|Secondary|Stage N3 (Min)|Stage N3 is considered as ‘deep sleep’. It is sometimes referred as slow wave sleep.|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
1316686|NCT02387476|Secondary|Stage N2 (Min)|Stage N2 sleep predominates the sleep stages with 50% of the total sleep time. It follows the Stage N1 sleep and continues to recur throughout the night.|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
1316687|NCT02387476|Secondary|Stage N1 (Min)|Stage N1 sleep is an estimate of the degree of sleep fragmentation.|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
1316688|NCT02387476|Secondary|Wakefulness (Min)|Measure of time not sleeping (minutes)|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
1316689|NCT02387476|Secondary|Mean Sleep SpO2 -(%)|Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||percentage of O2 Saturation||Standard Deviation|Mean
1316690|NCT02387476|Secondary|Minimum Sleep SpO2 (%)|The minimum O2 level percentage during treatment reported per treatment|per night||||percentage of O2 Saturation||Standard Deviation|Mean
1316691|NCT02387476|Secondary|Sleep Efficiency (SE%)|Sleep Efficiency (%) [100 x Total sleep time/ total recording time] reported per treatment|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||percentage of sleep efficiency||Standard Deviation|Mean
1316692|NCT02387476|Secondary|Arousal Index (AI)|The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds.|per hour|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||events per hour||Standard Deviation|Mean
1316693|NCT02387476|Primary|Oxygen Desaturation Index (ODI)|The Oxygen Desaturation Index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. The ODI is typically measured as part of standard sleep studies, such as a diagnostic polysomnogram, home sleep apnea testing, or with overnight oximetry.Difference of ODI values between patients who used the FRESCA treatment first versus the CPAP treatment.|per hour|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||events per hour||Standard Deviation|Mean
1316694|NCT02387476|Primary|Apnea Hypopnea Index (AHI)|The Apnea–Hypopnea Index or Apnoea–Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment.|per hour|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||events per hour||Standard Deviation|Mean
1316695|NCT02387268|Secondary|Percentage of Participants in Whom the Cecum Was Reached|A procedure was considered complete when the cecum was reached and visualized.|During the colonoscopy procedure||||percentage of participants||95% Confidence Interval|Number
1316696|NCT02387268|Primary|Safety as Measured by Number of Serious Adverse Events and Major Complications.||Max of 9 days|||||||
1316697|NCT02387268|Primary|Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )|"Scale ranges- Min-0, Max-3 where:~0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.~= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.~= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.~= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy."|During the colonoscopy procedure withdrawal phase (10 min in average)||||percentage of participants||95% Confidence Interval|Number
1316698|NCT02386098|Secondary|Number of Participants With Emergence of HIV Drug Resistance-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help assess the risk for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316699|NCT02386098|Secondary|Number of Participants With Emergence of HIV Drug Resistance-Stage 1|Emergence of drug resistance was planned to be assessed using the most current version of International AIDS Society-United States of America (IAS-USA); however, it was not assessed due to the early termination of the study in Stage 1.|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316700|NCT02386098|Secondary|AUC(Tau) for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316701|NCT02386098|Secondary|Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316702|NCT02386098|Secondary|C0 for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316703|NCT02386098|Secondary|Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316704|NCT02386098|Secondary|Ctau for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316705|NCT02386098|Secondary|Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316706|NCT02386098|Secondary|Tmax for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316707|NCT02386098|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1317280|NCT02368314|Primary|Frequency of DVT.|Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).|During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.|||participants|||Number
1316708|NCT02386098|Secondary|Cmax for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316709|NCT02386098|Secondary|Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1|The pharmacokinetic (PK) assessments were planned to be performed on PK Population, which comprised of all treated participants who had any available concentration-time data; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316710|NCT02386098|Secondary|Number of Participants With Occurrence of New AIDS Defining Events-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316711|NCT02386098|Secondary|Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1|The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented.|Up to Week 96|mITT Population|||Participants|||Count of Participants
1316712|NCT02386098|Secondary|Number of Participants With SAEs and AELDs-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316713|NCT02386098|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1|An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or medical events that may jeopardize the participant or require intervention (medical or surgical) to prevent one of the outcomes mentioned before. The number of participants with SAEs and AELDs are presented.|Up to Week 96|mITT Population|||Participants|||Count of Participants
1316714|NCT02386098|Secondary|Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Baseline and up to Week 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316715|NCT02386098|Secondary|Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1|The percentage of CD4+ cells was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.|Baseline and up to Week 72|mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Percentage of CD4+ cells||Standard Deviation|Mean
1316716|NCT02386098|Secondary|Change From Baseline in CD4+ Cell Count Over Time-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Baseline and up to Week 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316717|NCT02386098|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1|The CD4+ cell count was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.|Baseline and up to Week 72|mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Cells per microliter||Standard Deviation|Mean
1316718|NCT02386098|Secondary|Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Baseline and up to Week 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316719|NCT02386098|Secondary|Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1|Blood samples were collected for analysis of HIV-1 RNA. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.|Baseline and up to Week 72|mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)|||log10 c/mL||Standard Deviation|Mean
1316720|NCT02386098|Secondary|Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2|Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the Study during Stage 1.|Weeks 24, 48 and 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316731|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316721|NCT02386098|Secondary|Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.|Weeks 24, 48 and 96|mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)|||Percentage of participants||95% Confidence Interval|Number
1316722|NCT02386098|Secondary|Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2|Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.|Weeks 48 and 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316723|NCT02386098|Secondary|Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <40 c/mL at Weeks 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.|Weeks 48 and 96|mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Percentage of participants||95% Confidence Interval|Number
1316724|NCT02386098|Primary|Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2|Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.|Week 24|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
1316725|NCT02386098|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF.|Week 24|mITT Population|||Percentage of participants||95% Confidence Interval|Number
1316726|NCT02385526|Primary|Percent Patients Reaching the Defined Target Dose|Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame|12 weeks post implant|Population of subjects implanted with Vagus Nerve Therapy generator who received stimulation via left, tenth cranial nerve at varying dosing methods (device settings adjustments) depending on the group each subject was randomized. All subject had a common, final target dose to achieve but used alternate methods to achieve the target dose.|||Participants|||Count of Participants
1316727|NCT02384538|Secondary|Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit|"Participants were asked how much they were affected by hand OA by responding to the question Considering all the ways your hand OA affects you, how have you been during the last 48 hours? using an 11-point scale (NRS-11). Scores range from 0 to 10 points, with higher scores indicating greater effect of hand OA on the participant. A decrease in the NRS-11 score represents an improvement the effect of hand OA on the participant."|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316728|NCT02384538|Secondary|Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit|Participants rated the pain intensity of each hand during the previous 48 hours using an 11-point scale (NRS-11). The change from baseline to each visit in NRS-11 in the index hand (the hand with the most disease) are presented. Scores range from 0 to 10 points, with higher scores indicating greater pain intensity. A decrease in the NRS-11 score represents a decrease in pain intensity.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316729|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The total score ranges from 0 to 150; lower scores indicate better status. A decrease in the total score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316730|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The stiffness subdomain score ranges from 0 to 10; lower scores indicate better status. A decrease in the stiffness subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316732|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316733|NCT02384538|Primary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline), Week 16|mITT population: all randomized participants who received at least 1 dose of study drug.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316734|NCT02384096|Primary|Number of Participants With Paresthesia Coverage ≥50%|Paresthesia Coverage assesses how much of the subject’s painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.|7, 14 days post activation|All subjects who completed the day 7 and day 14 post-activation study visits were included. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.|||Participants|||Number
1316735|NCT02384070|Secondary|Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure||48 hours post procedure||||participants|||Number
1316736|NCT02384070|Secondary|TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores|"Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding.~Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention"|Hospital Stay and after 30 days post PCI||||Patients|||Number
1316737|NCT02384070|Primary|Thrombotic Complications||Hospital Stay and after 30 days post PCI||||Number of Patients|||Number
1316738|NCT02383862|Secondary|Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of medications ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0, 1, 2, or 3≤ medications ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
1316739|NCT02383862|Secondary|Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of tests ordered, other than radiologic or laboratory tests (e.g., sleep study), for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
1316740|NCT02383862|Secondary|Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of radiologic (RAD) tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ RAD tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
1316741|NCT02383862|Secondary|Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of laboratory tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ lab tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
1316742|NCT02383862|Secondary|Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, fatigue was assessed using the 4-item SF-36 (Short Form-36 Healthy Survey) vitality scale. The SF-36 vitality scale measures fatigue and energy over the past week. Possible scores range from 0 to 100, with lower scores reflecting greater fatigue.|3 month follow up|Participants who completed the SF-36 vitality scale at 3 month follow up|||units on a scale||Standard Deviation|Mean
1316743|NCT02383862|Secondary|Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, depression was assessed using the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the last 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe depression.|3 month follow up|Participants who completed the PHQ-2 at 3 month follow up|||units on a scale||Standard Deviation|Mean
1316783|NCT02382744|Secondary|Time Required to Administer Block|The time required for the block to be completed (from scanning to removal of needle)|10 minutes||||s||Standard Deviation|Mean
1316784|NCT02382744|Secondary|Rate of Success of Elicitation of a Tapping Sensation at < 0.6 Milliampere (mA)|Successful elicitation of “tapping” sensation in the saphenous nerve distribution at ≤ 0.6 mA|5 minutes|"Participants in the Ultrasound Guidance and nerve stimulation group with successful stimulation and available current magnitude data"|||participants|||Number
1316744|NCT02383862|Secondary|Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, anxiety was assessed using the 2-item Generalized Anxiety Disorder scale (GAD-2). GAD-2 measures the frequency of anxiety symptoms over the past 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe anxiety.|3 month follow up|Participants who completed the GAD-2 at 3 month follow up|||units on a scale||Standard Deviation|Mean
1316745|NCT02383862|Secondary|Pain at 3 Month Follow up, as Measured by PEG|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, pain was assessed using the 3-item PEG (Pain intensity, Enjoyment of life, and General activity). PEG measures pain intensity and interference in the past week. Possible scores range from 0 to 10, with higher scores reflecting more intense pain and interference.|3 month follow up|Participants who completed the PEG at 3 month follow up.|||units on a scale||Standard Deviation|Mean
1316746|NCT02383862|Secondary|Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, sleep was assessed using the 2-item Pittsburgh Insomnia Rating Scale (PIRS-2). PIRS-2 measures quality and satisfaction with sleep over the past week. Possible scores range from 0 to 6, with higher scores reflecting poorer sleep.|3-month follow-up|Participants who completed the PIRS-2 at 3 month follow up|||units on a scale||Standard Deviation|Mean
1316747|NCT02383862|Secondary|Treatment Satisfaction at 3-Month Follow-up|At 3-month follow-up, treatment satisfaction was assessed. This 1-item measure assesses patients' satisfaction with the care of their symptoms overall on a 5-point Likert scale ranging from excellent to poor. Higher scores indicate poorer satisfaction.|3 month follow-up|Participants who responded to the treatment satisfaction question at 3 month follow up|||Participants|||Count of Participants
1316748|NCT02383862|Secondary|Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up|The 4-item PROMIS subscale for fatigue was administered to participants at baseline and at 3 month follow up. The fatigue subscale measures the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. To assess the effects of feedback on fatigue, group differences in the change in PROMIS fatigue T-scores from baseline to 3-month follow up (baseline PROMIS fatigue T-score - 3 month PROMIS fatigue T-score) were calculated. Positive change scores are indicative of improvement in fatigue.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
1316749|NCT02383862|Secondary|Change From Baseline in PROMIS Depression T-score at 3-Month Follow up|The 4-item PROMIS subscale for depression was administered to participants at baseline and at 3 month follow up. The depression subscale measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater depression. To assess the effects of feedback on depression, group differences in the change in PROMIS depression T-scores from baseline to 3-month follow up (baseline PROMIS depression T-score - 3 month PROMIS depression T-score) were calculated. Positive change scores are indicative of improvement in depression.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
1316750|NCT02383862|Secondary|Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up|The 4-item PROMIS subscale for anxiety was administered to participants at baseline and at 3 month follow up. The anxiety subscale measures the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater anxiety. To assess the effects of feedback on anxiety, group differences in the change in PROMIS anxiety T-scores from baseline to 3-month follow up (baseline PROMIS anxiety T-score - 3 month PROMIS anxiety T-score) were calculated. Positive change scores are indicative of improvement in anxiety.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
1316751|NCT02383862|Secondary|Change From Baseline in PROMIS Pain T-score at 3-Month Follow up|The 4-item PROMIS subscale for pain was administered to participants at baseline and at 3 month follow up. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater pain. To assess the effects of feedback on pain, group differences in the change in PROMIS pain T-scores from baseline to 3-month follow up (baseline PROMIS pain T-score - 3 month PROMIS pain T-score) were calculated. Positive change scores are indicative of improvement in pain.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
1316752|NCT02383862|Secondary|Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up|The 4-item PROMIS subscale for sleep was administered to participants at baseline and at 3 month follow up. The sleep subscale measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. Higher scores reflect more severe sleep problems. To assess the effects of feedback on sleep, group differences in the change in PROMIS sleep T-scores from baseline to 3 month follow up (baseline PROMIS sleep T-score - 3 month PROMIS sleep T-score) were calculated. Positive change scores are indicative of improvement in sleep.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
1316753|NCT02383862|Primary|Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up|The 20-item PROMIS questionnaire (composed of 4-item scales for each of the 5 SPADE symptoms) was administered to participants at baseline and at 3 month follow up. PROMIS assesses the extent to which patients experience problems with SPADE symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity. To assess the effects of feedback on SPADE symptom improvement, group differences in the change in PROMIS composite T-scores from baseline to 3 month follow up (baseline PROMIS T-score - 3 month PROMIS T-score) were calculated. Positive change scores are indicative of symptom improvement.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
1317281|NCT02368093|Primary|Good European League Against Rheumatism (EULAR) Therapeutic Response Rate||6 months||||participants|||Number
1316754|NCT02383758|Secondary|Mean Clinical Global Impression for Improvement (CGI-I) Score|An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Improvement (CGI-I). Clinical Global Impression for Improvement (CGI-I) Scale is a clinician's assessment of a patient's change in condition from baseline.The score ranges from 0 = not assessed, 1 = very much improved, through 7 = very much worse.|Post-Intervention (Week 6), Post-Intervention (Week 10)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||units on a scale||Standard Deviation|Mean
1316755|NCT02383758|Secondary|Mean Clinical Global Impression for Severity (CGI-S) Score|An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant’s encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician’s assessment of patient’s severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients|Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||units on a scale||Standard Deviation|Mean
1316756|NCT02383758|Secondary|Percent Independence|Percent independence is the percentage of independent bowel movements recorded by a caregiver. A continent bowel movement without the use of any medications will constitute an independent bowel movement.|Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||percentage of participants|||Number
1316757|NCT02383758|Primary|Percent Continent|The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).|Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||percentage of participants|||Number
1316758|NCT02383719|Primary|Clinician Assessment of Use With a Questionnaire|"With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes.~The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree"|During non-invasive ventilation with the oro-nasal mask||||units on a scale||Inter-Quartile Range|Median
1316759|NCT02383576|Primary|Overall Survival|Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||months||95% Confidence Interval|Median
1316760|NCT02383576|Primary|Progression Free Survival (PFS)|PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||months||95% Confidence Interval|Median
1316761|NCT02383576|Primary|Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy|Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||days||Full Range|Median
1316762|NCT02383576|Primary|Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment|Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||percentage of participants|||Number
1316763|NCT02383576|Primary|Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy|Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||percentage of participants|||Number
1316785|NCT02382744|Secondary|Mean Minimum Stimulation Current|the mean minimum stimulation current magnitude to elicit “tapping” sensation in the saphenous nerve distribution (cf. 3.2.3 below)|5 minutes|"Participants in the Ultrasound Guidance and nerve stimulation group with available data"|||mA||95% Confidence Interval|Mean
1316764|NCT02383472|Secondary|Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6|"This measure indicates the mean difference in total cognitive symptom scores between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 weeks scores. The total cognitive symptom scored is a sum of 7 symptom scores from the PCSS; feeling slowed down, feeling like in a fog, don't feel right, difficulty concentrating, difficulty remembering, fatigue or low energy, and confusion. The severity of these symptoms are scored 0-6, 0=none, 6=severe. The range for the total cognitive symptom score is 0-42, a lower score represents a better outcome."|From baseline to 3 weeks and from baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
1316765|NCT02383472|Secondary|Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6.|This measure indicates the mean differences in total post concussion symptom score (PCSS) between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. The PCSS is a sum of severity scores from 0-6 (0=none, 6=severe) for 22 individual symptoms, like headache, neck pain, or drowsiness. The range for the PCSS is 0-132, a lower score represents a better outcome.|From baseline to 3 weeks and from baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
1316766|NCT02383472|Secondary|Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6.|This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs Verbal Fluency Test, made up of letter fluency and category fluency, is measured by number of responses, a larger number represents a better outcome. Participants were given 60 seconds to complete each fluency test.|From baseline to 3 weeks and from baseline to 6 weeks||||Correct responses||Standard Deviation|Mean
1316767|NCT02383472|Secondary|Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6.|This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs color-word interferences, made up of color naming, word reading, and inhibition, is measured in seconds, a smaller number represents a better outcome. Participants were given 90 seconds to complete color naming and word reading and 180 seconds to complete inhibition. D-KEFs trail making test, made up of number sequencing, letter sequencing, and number-letter sequencing, is measured in seconds, a faster speed (lower number) represents a better outcome. Participants were given 150 seconds to complete number and letter sequencing and 240 seconds to complete number-letter sequencing.|From baseline to 3 weeks and from baseline to 6 weeks||||Seconds||Standard Deviation|Mean
1316768|NCT02383472|Primary|Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks.|The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. The ranges for these subscales are as follows: verbal memory and visual memory: 0-100, visual motor speed: 0-60, reaction time: 0-1.0, and symptom score: 0-132. A higher verbal memory, visual memory, and visual motor speed represent a better outcome, while a lower reaction time and lower symptom score represent a better outcome.|From baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
1316769|NCT02383420|Secondary|Pair Preference Rating Scale|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects|||units on a scale|Participants|Standard Error|Mean
1316770|NCT02383420|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 177 image pairs were included for the reader study. Of the 177 pairs, 160 were cadaver image pairs. A total of seventeen (17) adult live human subject pairs were included in the reader study.|||units on a scale|Participants|Standard Error|Mean
1316786|NCT02382744|Secondary|Rate of Success of Elicitation of a Tapping Sensation|successful elicitation of any “tapping” sensation in the saphenous nerve distribution within the 5 min stimulation time limit|5 minutes||||participants|||Number
1316834|NCT02380261|Primary|Number of Participants With Ocular Clinical Signs and Discomfort Sensations|Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.|||participants|||Number
1316771|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 FHA and PRN was 33, 28, 28, 32 respectively.|||Ratios||95% Confidence Interval|Geometric Mean
1316772|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set|||Ratios||95% Confidence Interval|Geometric Mean
1316773|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 PT, FHA and PRN was 27, 32, 31, 32 respectively.|||Ratios||95% Confidence Interval|Geometric Mean
1316774|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.|||IU/mL||95% Confidence Interval|Geometric Mean
1316775|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.|||IU/mL||95% Confidence Interval|Geometric Mean
1316776|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|"Analysis were done on per protocol set (PPS) i.e., All subjects in the all enrolled set who provided immunogenicity data at V113_01E1 visit 1 and:~correctly received the vaccine in the V113_01 parent study~had no major protocol deviations leading to exclusion or were not excluded due to other reasons as defined prior to analysis"|||IU/mL||95% Confidence Interval|Geometric Mean
1316777|NCT02382744|Post-Hoc|Response Versus Lack of Response to Nerve Stimulation and Block Failure Rate|Percentage of block failure (persistent sensation in the saphenous nerve distribution at 30 minutes -- i.e., absence of any evidence of blockade [decreased or complete absence of sensation] at both areas: normal sensation) among participants in the Ultrasound Guidance and Nerve Stimulation group with response versus no response to nerve stimulation|30 min||||participants|||Number
1316778|NCT02382744|Post-Hoc|Sensory Blockade Scores by Individual Assessment Area: Medial Tibial Condyle|Sensation to pinprick with an 18 gauge blunt needle was assessed individually at the two different anatomic areas in the distribution of the saphenous nerve: Here, the results are reported for the area 10 cm distal to the medial tibial condyle only|30 min||||participants|||Number
1316779|NCT02382744|Post-Hoc|Sensory Blockade Scores by Individual Assessment Area: Medial Malleolus|Sensation to pinprick with an 18 gauge blunt needle was assessed individually at the two different anatomic areas in the distribution of the saphenous nerve: Here, the results are reported for the area 2 cm proximal to the medial malleolus only|30 min||||participants|||Number
1316780|NCT02382744|Post-Hoc|Speed of Onset for Any Blockade in the Area 2 cm Proximal to the Medial Malleolus Only|"Median (Kaplan-Meier curve survival) time required to reach any evidence of sensory blockade (decreased or complete absence of sensation) in the area 2 cm proximal to the medial malleolus only"|30 min|Participants with any evidence of sensory blockade (decreased or complete absence of sensation) in the area 2 cm proximal to the medial malleolus only|||Minutes||95% Confidence Interval|Median
1316781|NCT02382744|Secondary|Delayed Complications|Any complication as a results of nerve block placement (e.g. persistent paresthesia, nerve injury)|7 days post operative||||participants|||Number
1316782|NCT02382744|Secondary|Immediate Complications|Any complications as a result of block placement (e.g. local anesthetic toxicity, hematoma, pain etc.)|60 minutes post block completion||||participants|||Number
1316787|NCT02382744|Secondary|Speed of Onset for Nerve Block (Complete Blockade)|"Median (Kaplan-Meier curve survival) time required to reach complete absence of sensation to pinprick at the two different anatomic areas of assessment in the distribution of the saphenous nerve (2 cm proximal to the medial malleolus and 10 cm distal to the medial condyle of the tibia)."|30 minutes post nerve block|Participants with complete absence of sensation to pinprick at the two different anatomic areas of assessment in the distribution of the saphenous nerve (2 cm proximal to the medial malleolus and 10 cm distal to the medial condyle of the tibia)|||Minutes||95% Confidence Interval|Median
1316788|NCT02382744|Secondary|Incomplete Block Rate|incomplete [decreased only] loss of sensation in the saphenous nerve distribution at 30 minutes at both areas of assessment|30 minutes post nerve block||||participants|||Number
1316789|NCT02382744|Secondary|Any Evidence of Blockade (Decreased or Complete Absence of Sensation)|Participants with any evidence of blockade (decreased or complete absence of sensation) at the two different anatomic areas in the distribution of the saphenous nerve (2 cm proximal to the medial malleolus and 10 cm distal to the medial tibial condyle)|30 min||||participants|||Number
1316790|NCT02382744|Secondary|Block Failure Rate|Persistent sensation in the saphenous nerve distribution at 30 minutes (i.e., absence of any evidence of blockade [decreased or complete absence of sensation] at both areas: normal sensation.|30 minutes post nerve block||||participants|||Number
1316791|NCT02382744|Primary|Block Success|Complete absence of sensation to pinprick at two different anatomic areas of the saphenous nerve at thirty minutes|30 minutes post nerve block||||participants|||Number
1316792|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
1316793|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
1316794|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
1316795|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
1316796|NCT02382640|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
1316797|NCT02382640|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1316798|NCT02382640|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1316799|NCT02382640|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat||Days 1 at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1316800|NCT02382133|Secondary|Device Related Pressure Ulcer|"assessment for development of pressure ulcer at forehead sensor, OxiMaxTM, Nellcor,Covidien and nasal alar sensor, Alar One-SenseTM, Xhale Assurance"|5 days|incidence of any pressure injury|||participants|||Number
1316801|NCT02382133|Primary|Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation|accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures|24 hours|Nasal sensor unable to obtain a signal 7% of measures on enrollment, Forehead sensor unable to obtain signal 32% of measures on enrollment.|||Participants|||Count of Participants
1316802|NCT02381795|Primary|Headache Pain Intensity|Greatest change in headache pain intensity post treatment (at any time point within 30 minutes of Nasal CO2 administration) - pre-treatment. Pain intensity will be measured as follows: 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain. Full Range values were calculated change values, and do not represent the full range of the scale.|Immediately preceeding treatment to 30 minutes post-treatment|Enrolled subjects reporting at least one headache during study period. One enrolled subject did not experience any headaches during the study period and thus was not included in the analysis.|||units on a scale|Cluster Headaches|Full Range|Mean
1316803|NCT02381678|Primary|The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography|This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography|7-15 years after heart valve replacement surgery (during 2001-2007)||||Percentage of all subjects|||Number
1316804|NCT02381418|Secondary|Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.||up to 3 weeks post vaccination||||participants|||Number
1316805|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.|||fold change||95% Confidence Interval|Mean
1317732|NCT02357940|Primary|Percentage With Edema on the Legs at Day 1|Percentage of adults and babies with edema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1316806|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.|||percentage of subjects||95% Confidence Interval|Number
1316807|NCT02381392|Secondary|Success in Patients With High Difficult Intravenous Access Scores|Successful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
1316808|NCT02381392|Secondary|Nursing Satisfaction (Likert Scale)|To compare nursing satisfaction using a Likert scale between use of the AV400 and the standard technique.|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
1316809|NCT02381392|Secondary|Parent Satisfaction (Likert Scale)|To compare parent satisfaction using a Likert scale between use of the AV400 and the standard technique|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
1316810|NCT02381392|Secondary|Median Number of Intravenous Attempts|To compare the median number of IV access attempts until success or escalation of therapy to the difficult IV access team between those placed with the AV400 as to those without (ie the standard technique).|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
1316811|NCT02381392|Primary|First Attempt Success at Intravenous Access|Successful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
1316812|NCT02381288|Secondary|Terminal Elimination Half-life (T1/2) for TAK-448F|T1/2 is the time required for half of the drug to be eliminated from the plasma.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.||||||
1316813|NCT02381288|Secondary|AUCt: Area Under the Plasma Concentration-Time Curve for TAK-448F|Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.||||||
1316814|NCT02381288|Secondary|Cmax: Maximum Observed Plasma Concentration for the Free Form of TAK-448 (TAK-448F)|Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.||||||
1316815|NCT02381288|Secondary|Serum Testosterone Cmax: Maximum Observed Plasma Concentration|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Assessments were done Day 1 and Day 42 for once daily regimen, on Day 36 for once weekly regimen and on Day 39 for twice-weekly regimen (Day 42/36/39).|Day 1 (first dose) and Day 42 for once-daily regimen, Day 39 for twice-weekly regimen, or Day 36 for once-weekly regimen (last dose)|PD analysis set included all participants who received at least 1 dose of study drug or placebo and who have at least 1 valid PD measure.|||ng/dL||Standard Deviation|Mean
1316816|NCT02381288|Primary|Trough Serum Concentration (Ctrough) of ST|Trough serum concentration of total and free ST, defined as lowest Baseline concentration.|Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36|PD analysis set included all participants who received at least 1 dose of study drug or placebo and who had at least 1 valid PD measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/dL||Standard Deviation|Mean
1316817|NCT02381288|Primary|Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing|Cav is the average serum concentration of the dosing interval, calculated as area under the effect curve (AUEC) divided by the duration of the dosing interval.|Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36|Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug or placebo and who had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
1316818|NCT02380742|Secondary|VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain|Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Insertion of Pessary|After baseline and removal study activities were recorded, one of the patients in the placebo group was withdrawn by the investigator due to vaginal erosion.|||Centimeters||Standard Error|Least Squares Mean
1316819|NCT02380742|Secondary|VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age|Self-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Removal of Pessary||||Centimeters||Standard Error|Least Squares Mean
1316820|NCT02380742|Secondary|VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training|Self-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Removal of Pessary||||Centimeters||Standard Error|Least Squares Mean
1316835|NCT02380261|Primary|Number of Participants With a Contact-dermatitis Adverse Reaction|Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.|||participants|||Number
1316836|NCT02380248|Primary|Change From Baseline in Corneal Staining at All Study Time Points|Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.|Baseline (Day 0), Day 45, Day 90|Full Analysis Set. Number analyzed includes number of subjects with non-missing response in specified category.|||units on a scale||Standard Error|Mean
1316837|NCT02379923|Secondary|Procedural Success (Evaluated According to Crossing Technique)|The percentage of subjects with procedure success according to crossing technique|Through hospital discharge||||Participants|||Count of Participants
1316838|NCT02379923|Secondary|Mean Absorbed Radiation Dose in mGy|Absorbed radiation dose in mGy during procedure|During Procedure|Data recorded for 161 of 163 subjects|||milligray (mGy)||Standard Deviation|Mean
1316839|NCT02379923|Secondary|Mean Contrast Volume|Volume of contrast administered during procedure|During Procedure||||milliliters||Standard Deviation|Mean
1316840|NCT02379923|Secondary|Mean Procedural Time|The length of the procedure (The first successful insertion of the guide catheter at an arteriotomy site is considered the start of the procedure. A procedure is considered complete once the guide catheter is removed from the arteriotomy site.)|During Procedure|Data collected for 162 of 163 subjects|||minutes||Standard Deviation|Mean
1316841|NCT02379923|Secondary|Frequency of Dissection|Frequency of dissection reported during the procedure|During procedure||||Participants|||Count of Participants
1316842|NCT02379923|Secondary|Frequency of Perforation|Frequency of perforation during the procedure.|During Procedure||||Participants|||Count of Participants
1316843|NCT02379923|Secondary|Frequency of In-hospital MACE|Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI.|Up to hospital discharge||||Participants|||Count of Participants
1316844|NCT02379923|Secondary|Frequency of Successful Recanalization|Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.|During Procedure||||Participants|||Count of Participants
1316845|NCT02379923|Primary|Procedure Success|Angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital MACE.|Through hospital discharge, typically 24 hours post procedure||||Participants|||Count of Participants
1316846|NCT02379637|Secondary|Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)|Number of patients with adverse advents|7 Days||||participants|||Number
1316847|NCT02379637|Primary|Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)|Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours|72 hours|Full Analysis set|||log-transformed total cough count||Standard Deviation|Mean
1316848|NCT02379585|Secondary|Plasma Blood-based Tumor-related Abnormalities in DNA|To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1316849|NCT02379585|Secondary|Changes in Insulin-like Growth Factor-1|To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1316850|NCT02379585|Secondary|Glucose After Fasting and Chemotherapy|To investigate changes in glucose after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1316851|NCT02379585|Secondary|Nutritional Assessment Before and After Neoadjuvant Chemotherapy|Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1316852|NCT02379585|Secondary|Biomarker Changes Before and After Chemotherapy|Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1316853|NCT02379585|Secondary|Insulin Abnormalities|Changes in plasma insulin abnormalities after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1316854|NCT02379585|Secondary|Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy|To evaluate pathological complete remission rate (defined as disappearance of all invasive tumor in the breast; ypT0-is) at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm, ypT1a-b) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy for triple-negative breast cancer.|4-6 cycles|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1321218|NCT02274870|Secondary|Mean Plasma Bupivicaine Level||72hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
1316855|NCT02379585|Secondary|Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI|The effect of short-term fasting on the toxicity of neoadjuvant chemotherapy in breast cancer patients according to the NCI common toxicity criteria (Version 4.03)|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1316856|NCT02379585|Primary|Pathological Response Rate at the Time of Surgery or at the Time of Biopsy|Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy.|4-6 cycles (up to 12 weeks)|Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information. After much effort, results were not able to be retained.||||||
1316857|NCT02378961|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1316858|NCT02378961|Secondary|HCV RNA Change From Baseline||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1316859|NCT02378961|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed|||percentage of participants||95% Confidence Interval|Number
1316860|NCT02378961|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1316861|NCT02378961|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 Weeks|Safety Analysis Set|||percentage of participants|||Number
1316862|NCT02378961|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Posttreatment Week 12|Full Analysis Set (FAS): participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1316863|NCT02378935|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1316864|NCT02378935|Secondary|HCV RNA Change From Baseline||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed|||log10 IU/mL||Standard Deviation|Mean
1316865|NCT02378935|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed|||percentage of participants||95% Confidence Interval|Number
1316866|NCT02378935|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1316867|NCT02378935|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 Weeks|Safety Analysis Set|||percentage of participants|||Number
1316868|NCT02378935|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Posttreatment Week 12|Full Analysis Set (FAS): participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1316869|NCT02378753|Secondary|Number of Participants With Occurrence of Solicited and Unsolicited AEs During the 28 Days Following the Vaccination or Enrollment|Solicited local and systemic reactogenicity symptoms and unsolicited adverse events were assessed in safety sub-study participants (the first 449 participants enrolled at the COMAHS Library site), during the 28 days after vaccination (immediate group) or after enrollment without vaccination (deferred group).|During 28 days following vaccination||||Participants|||Count of Participants
1316870|NCT02378753|Secondary|Number of Participants With Occurrence of Solicited Injection-site and Systemic Reactogenicity Signs and Symptoms, Including Fever, on Vaccination Day and During the 7 Days Following the Vaccination or Enrollment.|Solicited symptoms were assessed only in safety sub-study participants (the first 449 participants enrolled at the COMAHS Library site), during the 7 days after vaccination (immediate group) or after enrollment without vaccination (deferred group). Participants were actively solicited for the occurrence of local (injection-site) pain, redness, and swelling and the following systemic reactogenicity symptoms: fever, joint pain, joint swelling, muscle pain, fatigue, feeling unwell, chills, headache, vomiting, nausea, diarrhea, abdominal pain, rash, oral ulcers, and skin vesicles (blisters).|Vaccination day and for 7 days following vaccination||||Participants|||Count of Participants
1316888|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Week 24|"Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1316871|NCT02378753|Secondary|Suspected, Probable or Laboratory-confirmed Ebola|"Incidence of suspected, probable, or laboratory-confirmed Ebola, where suspected and probable cases are defined by the August 9, 2014 World Health Organization case definition recommendations for use during an Ebola outbreak, and laboratory-confirmed Ebola includes both study laboratory and non-study laboratory diagnostics. An Ebola Screening Form was required to be completed for all participants referred for evaluation of suspected Ebola; the Outcome Measure (Count of Participants) reflects the number of participants in each group for whom an Ebola Screening Form was completed."|6 months following vaccination||||Participants|||Count of Participants
1316872|NCT02378753|Secondary|Ebola Confirmed by Non-study or Study Diagnostics|Incidence of Ebola confirmed by the STRIVE study laboratory or by a non-study laboratory in each treatment group during the Randomized Portion of the trial. For the vaccine efficacy endpoint, all enrolled participants in both arms were followed for 18-24 weeks after enrollment (after which point participants in the deferred cohort received crossover vaccination). Statistical analysis was to proceed as survival analysis (time-to-event/time-to-infection) of cohort follow-up data during this period. There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed.|6 months following vaccination|The Overall Number of Participants Analyzed for this endpoint is the number of participants with suspected Ebola in each group who provided biological samples for testing, whether to the study laboratory or to a non-study laboratory.|||Participants|||Count of Participants
1316873|NCT02378753|Secondary|Death Due to Laboratory-confirmed Ebola|Deaths due to Ebola confirmed by the STRIVE study laboratory in each treatment group during the Randomized Portion of the trial. There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed.|6 months following vaccination||||Participants|||Count of Participants
1316874|NCT02378753|Primary|Number of Participants With Occurrence of Serious Adverse Events During the 6 Months Following the Vaccination|Number of Participants with Occurrence of SAEs within the 6-month follow-up period following a single dose of rVSVΔG-ZEBOV. Vaccination in the immediate group occurred within 7 days of enrollment if possible, and vaccination in the deferred-vaccination group occurred 18-24 weeks after enrollment.|6 months following vaccination|The Overall Number of Participants Analyzed for this endpoint is the number of participants in each group who provided any safety/AE data during 6-month (18- to 24-week) follow-up.|||Participants|||Count of Participants
1316875|NCT02378753|Primary|Laboratory-confirmed Ebola (Study Diagnostics)|"Incidence of Ebola confirmed by the STRIVE study laboratory in each treatment group during the Randomized Portion of the trial. For the vaccine efficacy endpoint, all enrolled participants in both arms were followed for 18-24 weeks after enrollment (after which point participants in the deferred cohort received crossover vaccination). Statistical analysis was to proceed as survival analysis (time-to-event/time-to-infection) of cohort follow-up data during this period.~There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed."|> 21 days following vaccination|The Overall Number of Participants Analyzed for this endpoint is the number of participants with suspected Ebola in each group who provided biological samples to the study laboratory for testing.|||Participants|||Count of Participants
1316876|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Baseline up to Week 24|Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.|||percentage of participants||95% Confidence Interval|Number
1316877|NCT02378506|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||units on a scale||Standard Deviation|Mean
1316878|NCT02378506|Secondary|Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||units on a scale||Standard Deviation|Mean
1316879|NCT02378506|Secondary|Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24|DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||units on a scale||Standard Deviation|Mean
1321219|NCT02274870|Secondary|Opioid Consumption||24hrs||||Morphine milligram equivalents||95% Confidence Interval|Mean
1316880|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.|Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||percentage of participants||95% Confidence Interval|Number
1316881|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.|Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||percentage of participants||95% Confidence Interval|Number
1316882|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant’s overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.|Week 4, 12, 24|Modified intent-to-treat (mITT) population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||percentage of participants||95% Confidence Interval|Number
1316883|NCT02378506|Secondary|Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities|Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
1316884|NCT02378506|Secondary|Number of Participants With Injection Site Reactions|Injection site reactions included injection site erythema, swelling, pain and warmth.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
1316885|NCT02378506|Secondary|Number of Participants With Investigator-Identified Serious Infections|Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
1316886|NCT02378506|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
1316887|NCT02378506|Secondary|Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment|Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.|Baseline (Day 1) up to Week 24|Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.|||percentage of participants||95% Confidence Interval|Number
1316889|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Week 12|"Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, Number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1316890|NCT02378220|Secondary|Number of Clinician-accepted of Recommendations as Measured by Tabulation|To assess the proportion of study pharmacist recommendations acted on by clinicians.|60 days|"This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the tested group acted on by clinicians."|||recommendations|||Number
1316891|NCT02378220|Secondary|Number of Pharmacist-accepted of Recommendations as Measured by Tabulation|To assess the proportion of YouScript® Personalized Prescribing System recommendations accepted by the study pharmacist and passed on to clinicians.|60 days|"This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the tested group accepted by the study pharmacist and passed to clinicians."|||recommendations|||Number
1316892|NCT02378220|Secondary|Number of Falls as Measured by Tabulation|To assess whether YouScript® testing decreases falls|60 days||||Falls||Full Range|Mean
1316893|NCT02378220|Secondary|Activities of Daily Living as Measured by OASIS Scale|We assessed the impact of genetic testing on the frequency of activities of daily living (ADL) and instrumental activities of daily living (IADL) assistance according to OASIS M2110 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M2110, one data point in the OASIS system, measures frequency of receiving ADL/IADL assistance on a scale of 0 to 5, with a lower score indicating less frequent assistance.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of ADL and IADL according to OASIS M2110 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
1316894|NCT02378220|Secondary|Disruptive Behavior as Measured by OASIS Scale|We assessed the impact of genetic testing on frequency of disruptive behavior according to OASIS M1745 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1745, one data point in the OASIS system, measures frequency of disruptive behavior by patient on a scale of 0 to 5, with a lower score indicating less frequent disruptive behavior.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of disruptive behavior according to OASIS M1745 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
1316895|NCT02378220|Secondary|Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale|We assessed the impact of genetic testing on frequency of depressive mood according to PHQ-2 at 30 and 60 days post discharge. PHQ-2 evaluates patient depression by assessing two factors: frequency of little interest or pleasure in doing things and frequency of feeling down, depressed, or hopeless. This outcome measure assessed the second factor, frequency of feeling down or depressed. The scale for this factor ranges from 0 to 3, with a lower score represented less frequent depressive feelings.|30 days, 60 days post discharge|The secondary outcomes assessed feelings of depression according to PHQ-2 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
1316896|NCT02378220|Secondary|Anxiety as Measured by OASIS Scale|We assessed the impact of genetic testing on frequency of anxiety according to OASIS M1720 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1720, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 3, with a lower score indicating less frequent confusion.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of anxiety according to OASIS M1720 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
1316897|NCT02378220|Secondary|Confusion as Measured by OASIS Scale|We assessed the impact of genetic testing on frequency of confusion according to OASIS M1710 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1710, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 4, with a lower score indicating less frequent confusion.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of confusion according to OASIS M1710 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
1316898|NCT02378220|Secondary|Pain as Measured by OASIS Scale|We assessed the impact of genetic testing on patient pain frequency according to OASIS M1242 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1242, one data point in the OASIS system, measures patient pain frequency on a scale of 0 to 4, with a lower score indicating less frequent pain.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of pain according to OASIS M1242 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
1316899|NCT02378220|Secondary|Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale|We assessed the impact of genetic testing on overall status according to OASIS M1034 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1034, one data point in the OASIS system, measures overall patient status on a scale of 0 to 3, with a lower score indicating better overall status.|30 days, 60 days post discharge|The secondary outcomes assessed the overall status according to OASIS M1034 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
1316900|NCT02378220|Secondary|Time to 1st Emergency Department Visit|To assess time to first emergency department visit, we compared the exploratory time-to-event outcomes (time to 1st ED visit) between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects who visited the emergency department before or at 30 and 60 days.|30 days, 60 days|Compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.|||Percentage of participants|||Number
1317733|NCT02357940|Primary|Percentage With Edema on the Arms at Day 1|Percentage of adults and babies with edema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1316901|NCT02378220|Secondary|Time to 1st Re-hospitalization|To assess time to first re-hospitalization, we compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects re-hospitalized before or at 30 and 60 days.|30 days, 60 days|We compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.|||Percentage of participants|||Number
1316902|NCT02378220|Primary|The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.|Assessed the number of Emergency Department visits at 30 and 60 days post discharge with pharmacogenetic testing and YouScript® Personalized Prescribing system.|30 days, 60 days post discharge|The primary outcomes assessed the number of emergency department visits between the tested group and the untested group at 30 and 60 days post-discharge.|||ED visits||Full Range|Mean
1316903|NCT02378220|Primary|Number of Re-hospitalizations at 30 and 60 Days|The primary outcomes included the number of re-hospitalizations at 30 and 60 days.|30 days, 60 days post discharge|Primary outcomes included the number of re-hospitalizations between the tested group and the untested group at 30 and 60 days post-discharge.|||Re-hospitalizations||Full Range|Mean
1316904|NCT02377921|Secondary|Change From Baseline in GNEM FAS Upper Extremity Domain Score at Week 48|Upper extremity use and function was assessed using the Mobility domain of the GNEM-FAS instrument a disease-specific measure developed to assess the functional impact of changes in muscle strength on mobility (reflective of the upper extremities). This mobility score ranges from 0 to 40 with higher scores representing greater mobility.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316905|NCT02377921|Secondary|Change From Baseline in Percent Predicted Meters Walked in the 6MWT at Week 48|The total distance walked (meters) in a 6-minute period was measured, and the percent predicted distance based on normative data for age and gender was estimated.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||percentage of predicted meters||95% Confidence Interval|Least Squares Mean
1316906|NCT02377921|Secondary|Change From Baseline in Meters Walked in the 6MWT at Week 48|The total distance walked (meters) in a 6-minute period was measured.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||meters||95% Confidence Interval|Least Squares Mean
1316907|NCT02377921|Secondary|Change From Baseline in Number of Stands in the Sit to Stand Test at Week 48|Lower extremity function was assessed using a sit-to-stand test. The number of times the participant can rise from a seated to a standing position in a 30-second period was recorded.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||stands||95% Confidence Interval|Least Squares Mean
1316908|NCT02377921|Secondary|Change From Baseline in Number of Lifts in the 30 Second Weighted Arm Lift Test at Week 48|Upper extremity function was assessed using a weighted arm lift test performed bilaterally. The number of times the participant can raise a 1 kg weight above the head in a 30-second period was recorded.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||arm lifts||95% Confidence Interval|Least Squares Mean
1316909|NCT02377921|Secondary|Change From Baseline in GNEM FAS Mobility Domain Score at Week 48|Lower extremity use and function was assessed using the Mobility domain of the GNEM-FAS instrument a disease-specific measure developed to assess the functional impact of changes in muscle strength on mobility (reflective of the lower extremities). This mobility score ranges from 0 to 40 with higher scores representing greater mobility.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
1316910|NCT02377921|Secondary|Change From Baseline in LEC Score (Total Force in kg) at Week 48|Muscle strength based on MVIC against a dynamometer was measured bilaterally in the following lower extremity muscle groups: knee flexors, hip flexors, hip extensors, hip abductors and hip adductors. The LEC is derived from the sum of the average of the right and left total force values (measured in kg).|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
1316911|NCT02377921|Secondary|Change From Baseline in Muscle Strength in the Knee Extensors at Week 48|Lower extremity muscle strength in the knee extensors was measured by dynamometry. Bilateral total force was defined as the average of the right and left force values (measured in kg).|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
1316912|NCT02377921|Primary|Change From Baseline in UEC Score (Total Force in kg) at Week 48|Muscle strength based on the maximum voluntary isometric contraction (MVIC) against a dynamometer was measured bilaterally in the following upper extremity muscle groups: gross grip, shoulder abductors, elbow flexors, and elbow extensors. The UEC is derived from the sum of the average of the right and left total force values (measured in kg).|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
1316913|NCT02377466|Secondary|Volume of Distribution of Retosiban|Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion|Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|||Liters||Geometric Coefficient of Variation|Geometric Mean
1316914|NCT02377466|Secondary|Retosiban Clearance|Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion|Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
1316915|NCT02377466|Secondary|Number of Participants With Different Modes of Transportation to Hospital|The means by which the maternal participants were transported to the hospital i.e. ground ambulance/emergency vehicle (gr. amb/emer. veh), air ambulance, family member or other means were obtained from the review of medical records. The number of maternal participants with the corresponding mode of transportation is presented for preterm labor visit and delivery visit. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Participants|||Number
1316916|NCT02377466|Secondary|Number of Participants Admitted to Particular Hospital Unit|Maternal healthcare resource utilization associated with an episode of preterm labor, preterm delivery and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit has been presented.|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Participants|||Number
1316917|NCT02377466|Secondary|Number of Participants With Hospital Admissions Related to Preterm Labor and Preterm Delivery|Maternal healthcare resource utilization associated with an episode of preterm labor and preterm delivery were collected from the review of medical records. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. The number of participants who had hospital admission for preterm labor and preterm delivery has been presented. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|Up to 28 days after EDD (40 0/7 weeks of gestation)|Maternal Safety Population|||Participants|||Number
1316918|NCT02377466|Secondary|Maternal Length of Stay in Hospital|Details on maternal health care resource use (both for hospitalizations related to preterm labor not resulting in a delivery and hospitalizations related to preterm labor/normal labor resulting in a delivery) associated with an episode of preterm labor, preterm delivery and normal term delivery (>= 37 weeks gestation) were collected from review of medical records. Length of hospital stay associated with hospital admission for preterm labor and normal term labor/term delivery is presented. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. Only participants with data available at the specified time points were analyzed (indicated by n=X) in category titles. NA indicates standard deviation could not be calculated as only one participant was analyzed.|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Days||Standard Deviation|Mean
1316919|NCT02377466|Secondary|Number of Neonatal Participants With DRE|The disease related neonatal events occurring in Infants born prior to 37 completed weeks included: apnea (severe), respiratory failure due to fatigue, hypoxia, or air leak from alveolar injury, patent ductus arteriosus, bradycardia, ventriculomegaly, cerebellar hemorrhage, hydrocephalus other than congenital, gastroesophageal reflux, aspiration pneumonia, anemia, retinopathy of prematurity (all stages), hearing disorder, temperature instability and hypoglycemia. The number of participants with at least one DRE has been presented.|Up to 28 days after EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
1316920|NCT02377466|Secondary|Number of Neonatal Participants With AESI|Neonatal AESI included: Neonatal death; Asphyxia; Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis); RDS; Hypotension; IVH/periventricular leukomalacia; Bronchopulmonary dysplasia; Neonatal acidosis; Hyperbilirubinemia; Necrotizing enterocolitis; and Hypoxic ischemic encephalopathy. The number of neonatal participants who experienced at least one AESI has been presented.|Up to 28 days after EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
1316921|NCT02377466|Secondary|Number of Neonatal Participants With AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one AE and one SAE has been presented. Neonatal Safety Population consisted of neonates whose mothers received randomized treatment.|Up to 28 days after the EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
1316922|NCT02377466|Secondary|Head Circumference of Neonates|The head circumference was determined from the neonate birth record.|Up to 17 weeks|Neonatal ITT Population|||centimeters (cm)||Standard Deviation|Mean
1316923|NCT02377466|Secondary|Weight of Neonates|The weight of neonates was obtained from the neonate birth record. The mean weight of neonates and standard deviation has been presented.|Up to 17 weeks|Neonatal ITT Population|||grams (g)||Standard Deviation|Mean
1316924|NCT02377466|Secondary|Neonatal APGAR Scores|APGAR is a quick test to assess the health of new born children. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two, then summing up the five values obtained. APGAR score ranges from 0 to 10 where a score of 7 and above is normal. The mean and standard deviation of APGAR scores at one minute and at five minutes of birth has been presented.|Up to 5 minutes after birth|Neonatal ITT Population|||Score on APGAR scale||Standard Deviation|Mean
1316925|NCT02377466|Secondary|Number of Participants With Fetal AESI|Fetal AESI included: intrauterine fetal demise; category II or III fetal heart rate tracing; and fetal inflammatory response syndrome characterized by cord blood interleukin-6 >11 picogram per milliliter (pg/mL), funisitis, or chorionic vasculitis. The number of participants who experienced at least one AESI has been presented.|Up to 17 weeks|Maternal Safety Population|||Participants|||Number
1316926|NCT02377466|Secondary|Number of Participants With Fetal Acidosis|The number of participants with fetal acidosis is presented.|Up to 16 weeks|Maternal Safety Population|||Participants|||Number
1316964|NCT02377466|Secondary|Number of Participants With Births Prior to 37 0/7 Weeks Gestation|Gestational age at birth (weeks) is defined as the gestational age when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm, if the gestational age at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented.|Up to 13 weeks|Maternal ITT Population|||Participants|||Number
1316927|NCT02377466|Secondary|Number of Fetal Participants With AEs and SAEs Prior to Delivery|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Fetal AEs and SAEs included the adverse events that were experienced by the fetus prior to delivery. The number of fetal participants who experienced at least one AE and one SAE has been presented.|Up to 17 weeks post-infusion|Maternal Safety Population|||Participants|||Number
1316928|NCT02377466|Secondary|Number of Maternal Participants With Disease Related AEs (DRE)|Maternal DREs included: signs and symptoms of labor discomfort (example, cramping, backache, muscle aches, nausea); subsequent episodes of preterm labor and hospitalization for delivery. The number of participants with at least one DRE has been presented.|Up to 6 weeks post-delivery|Maternal Safety Population|||Participants|||Number
1316929|NCT02377466|Secondary|Number of Maternal Participants With AEs of Special Interest (AESI).|Maternal AESI included: maternal death; chorioamnionitis and its complications (clinical chorioamnionitis, preterm premature rupture of membranes, endomyometritis, wound infection, pelvic abscess, bacteremia, septic shock, disseminated intravascular coagulation, and adult RDS); placental abruption; postpartum hemorrhage – postpartum hemorrhage and/or retained placenta and pulmonary edema. The number of participants with at least one AESI has been presented.|Up to 6 weeks post-delivery|Maternal Safety Population|||Participants|||Number
1316930|NCT02377466|Secondary|Number of Maternal Participants With a Score of 12 or Higher on the Edinburgh Postnatal Depression Scale (EPDS)|The effect of preterm birth on maternal health status was assessed using the EPDS. The EPDS is a 10-item self-reported assessment of depression, validated for administration during both the antenatal and the post-natal periods. Items are rated on a 4-point variable Likert scale, ranging from 0 to 3. The total score was calculated by adding individual scores for each item and ranged from 0 to 30. A score of less than 8 indicates depression not likely; score of 9 to 11 indicates possible depression and a score of more than 12 indicates an increased probability of depression. Maternal participants were required to complete the EPDS at the maternal follow-up assessment 6 weeks post-delivery.|Up to 6 weeks post delivery|Maternal Safety Population|||Participants|||Number
1316931|NCT02377466|Secondary|Number of Participants Who Discontinued Study Treatment Due to Clinical and Laboratory Toxicities|Number of maternal participants who discontinued study treatment due to clinical and laboratory toxicities is presented.|Up to 48 hours post-infusion|Maternal Safety Population|||Participants|||Number
1316932|NCT02377466|Secondary|Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels|Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||micromoles per liter (µmol/L)||Standard Deviation|Mean
1316933|NCT02377466|Secondary|Change From Baseline in Anion Gap, Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level|Blood samples were collected for the evaluation of change from Baseline in levels of anion gap, calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1316934|NCT02377466|Secondary|Change From Baseline in Albumin and Protein Levels|Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||grams per liter (g/L)||Standard Deviation|Mean
1316935|NCT02377466|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels|Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||International Units per liter (IU/L)||Standard Deviation|Mean
1316936|NCT02377466|Secondary|Change From Baseline in Erythrocyte Level|Blood samples were collected for the evaluation of change in erythrocyte level from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Trillion cells per liter||Standard Deviation|Mean
1316937|NCT02377466|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV)|Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||femtoliter (fL)||Standard Deviation|Mean
1317006|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - My local physician was adequately informed about my participation in this trial (if applicable)."|6 months||||Participants|||Count of Participants
1316938|NCT02377466|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count|Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Billion cells per liter (L)||Standard Deviation|Mean
1316939|NCT02377466|Secondary|Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC)|Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||grams per liter (g/L)||Standard Deviation|Mean
1316940|NCT02377466|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected for the evaluation of change in hematocrit levels from Baseline. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
1316941|NCT02377466|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured with the participants in a semirecumbent or seated position. Respiratory rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||breaths per minute||Standard Deviation|Mean
1316942|NCT02377466|Secondary|Change From Baseline in Temperature|Temperature was measured with the participants in a semirecumbent or seated position. Temperature was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||degree Celsius||Standard Deviation|Mean
1316943|NCT02377466|Secondary|Change From Baseline in Heart Rate|Heart rate was measured with the participants in a semirecumbent or seated position. Heart rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 9 days|Maternal Safety Population|||beats per minute||Standard Deviation|Mean
1316944|NCT02377466|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|SBP and DBP were measured with participants in a semirecumbent or seated position. SBP and DBP were measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 9 days|Maternal Safety Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1316945|NCT02377466|Secondary|Number of Maternal Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that mey require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one AE and one SAE has been presented.|Up to 6 weeks after delivery|Maternal Safety Population|||Participants|||Number
1316946|NCT02377466|Secondary|Number of Participants With Subsequent Preterm Labor|The participants who had not delivered after 48 hours post-infusion were contacted to determine if they had delivered or experienced any subsequent episodes of preterm labor. A subsequent episode of preterm labor was only recorded if the participant reported it to the Principal Investigator during one of the telephone follow-up calls but did not then go on to immediately deliver. However, if labor started and led to immediate delivery, then the only data collected would be the pre-specified delivery data and thus would not be counted as a subsequent episode of preterm labor. The number of participants who had a subsequent episode of preterm labor after administration of the study treatment has been presented. Maternal Safety Population comprised of all maternal participants randomly assigned to treatment who have been exposed to study treatment.|Up to 11 weeks|Maternal Safety Population|||Participants|||Number
1316947|NCT02377466|Secondary|Number of Participants Who Received Any Putative Tocolytic|A putative tocolytic medication was the medication administered for active preterm labor or as prevention of preterm labor and included calcium channel blockers, nonsteroidal anti-inflammatory drugs, or beta agonists, or magnesium sulfate doses that exceeded prespecified IV loading doses, infusion rates, or total duration of administration.|Up to 17 weeks|Maternal Safety Population|||Participants|||Number
1317734|NCT02357940|Primary|Percentage With Edema on the Face at Day 1|Percentage of adults and babies with edema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1316948|NCT02377466|Secondary|Time to Treatment Failure|Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. Time to treatment failure is the number of days from the first dose of study treatment until treatment failure. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Only those maternal participants with treatment failure were included in the analysis. NA indicates standard deviation could not be calculated as only one participant was analyzed.|Up to 17 weeks|Maternal ITT Population|||Days||Standard Deviation|Mean
1316949|NCT02377466|Secondary|Number of Participants With Ambulatory Surgery|Information regarding participants who had ambulatory surgery was collected from the newborn medical records. The number of neonatal participants with ambulatory surgery is presented.|Up to 28 days post EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Participants|||Number
1316950|NCT02377466|Secondary|Length of Stay Following Readmission to Hospital|Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. Length of stay in hospital following readmission is presented for neonates.|Up to 28 days after EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Days||Full Range|Median
1316951|NCT02377466|Secondary|Number of Newborn Participants With Hospital Readmission|Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. The number of newborn participants who had readmission to hospital is presented.|Up to 28 days of EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Participants|||Number
1316952|NCT02377466|Secondary|Length of Stay in Specialized Care Unit|Neonatal healthcare resource utilization was collected from review of medical records. The length of stay in a specialized care unit (NICU or ICU) has been presented for neonatal participants with admission to ICU or NICU.|Up to 28 days post EDD (40 0/7 weeks gestation)|Neonatal Safety Population.|||Days||Standard Deviation|Mean
1316953|NCT02377466|Secondary|Number of Neonatal Participants With Admission to a Particular Hospital Unit|Neonatal healthcare resource utilization was collected from review of medical records. The number of neonatal participants who were admitted to a particular hospital unit that is, level III (or higher) intensive neonatal care (NICU), Intensive care unit (ICU), general ward, Level I - Basic Neonatal care, Well born nursery (SCBU) and Level II-Special Care Newborn nursery high dependency (NHDU) has been summarized. Neonatal Safety Population consisted of neonates whose mothers received study treatment.|Up to 28 days post EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Participants|||Number
1316954|NCT02377466|Secondary|Number of Neonates With Each Individual Component of the Composite Neonatal Morbidity and Mortality|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with each individual component of the composite component has been presented.|Up to 28 days after the EDD of 40 0/7 weeks|Neonatal ITT Population|||Participants|||Number
1316955|NCT02377466|Secondary|Number of Neonates With Any of the Co-primary Composite Neonatal Morbidity and Mortality, Excluding RDS|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with any co-primary composite neonatal morbidity and mortality component, excluding RDS has been presented.|Up to 28 weeks after EDD (40 weeks gestation)|Neonatal ITT Population|||Participants|||Number
1316956|NCT02377466|Secondary|Number of Participants With Births at <=24 Hours From the First Study Treatment|The number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.|Up to 24 hours|Maternal ITT Population|||Participants|||Number
1316957|NCT02377466|Secondary|Number of Participants With Births at <=48 Hours From the First Study Treatment|The number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.|Up to 48 hours|Maternal ITT Population|||Participants|||Number
1316958|NCT02377466|Secondary|Number of Participants With Births <=7 Days From the First Study Treatment|The number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.|Up to 7 days|Maternal ITT Population|||Participants|||Number
1316959|NCT02377466|Secondary|Number of Participants With Births Prior to 28 0/7 Weeks Gestation|The number of participants who delivered prior to 28 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 28 0/7 week's gestation and delivered were included.|Up to 4 weeks|Maternal ITT Population|||Participants|||Number
1316960|NCT02377466|Secondary|Number of Participants With Births Prior to 32 0/7 Weeks Gestation|The number of participants who delivered prior to 32 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 32 0/7 week's gestation and delivered were included.|Up to 8 weeks|Maternal ITT Population|||Participants|||Number
1316961|NCT02377466|Secondary|Number of Participants With Births Prior to 35 0/7 Weeks Gestation|The number of participants who delivered prior to 35 0/7 weeks gestation has been presented.|Up to 11 weeks|Maternal ITT Population|||Participants|||Number
1316962|NCT02377466|Secondary|Length of Neonatal Hospital Stay|The length of stay was collected from medical records and was calculated as the days between the delivery date and time and discharge date and time.|Up to 28 days post EDD of 40 0/7 weeks gestation|Neonatal ITT Population|||Days||Standard Deviation|Mean
1316963|NCT02377466|Secondary|Number of Participants With Births at Term|Participants were considered to have delivered at term if the gestational age was >=37 0/7. The number of participants who delivered at term, that is, 37 0/7 to 41 6/7 weeks gestation has been presented.|Up to 17 weeks|Maternal ITT Population|||Participants|||Number
1317007|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - This telemedicine approach eases the financial burden of participation in clinical trials for patients."|6 months||||Participants|||Count of Participants
1316965|NCT02377466|Secondary|Time to Delivery|The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The mean number of days to delivery along with standard deviation has been presented.|Up to 17 weeks|Maternal ITT Population|||Days||Standard Deviation|Mean
1316966|NCT02377466|Primary|Number of Neonates With Any Diagnosis From the Neonatal Morbidity and Mortality Composite Component|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, respiratory distress syndrome (RDS), bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, intraventricular hemorrhage (IVH), white matter injury and cerebellar hemorrhage. Neonates with any of the composite component has been presented. Statistical analysis was not performed due to early termination of study and resultant small sample size. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.|Up to 28 days after the estimated date of delivery (EDD) of 40 0/7 weeks|Neonatal ITT Population|||Participants|||Number
1316967|NCT02377466|Primary|Time to Delivery or Treatment Failure, Whichever Occurs First|Time to delivery or treatment failure is the number of days from the first dose of study treatment until delivery or treatment failure whichever occurs first. Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Statistical analysis was not performed due to early termination of the study and resultant small sample size.|Up to 17 weeks|Maternal ITT Population|||Days||Standard Deviation|Mean
1316968|NCT02377427|Secondary|Ratio to Baseline in Absolute Blood Eosinophil Count at Weeks 32, 44, 56, 68, 72 and 80 for Part B|Blood samples were collected at the indicated time points for the analysis of eosinophil count. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab in Part A. Ratio to Baseline was calculated as post-dose visit value/Baseline value. The analysis was based on Pharmacodynamic (Blood Eosinophils) (PDe) Population comprised of all participants receiving at least one dose of mepolizumab beginning at Visit 9 and having at least one Part B blood sample taken for blood eosinophil count. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 32, 44, 56, 68, 72 and 80|PDe Population|||Ratio of eosinophils in blood||95% Confidence Interval|Geometric Mean
1316969|NCT02377427|Secondary|Change From Baseline in Sitting Pulse Rate in Part A|Sitting pulse rate measurements was performed in Part A at indicated time points. Measurements were done pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4, 8, 9, 12, 16 and 20|Safety Population|||Beats per minute||Standard Deviation|Mean
1316970|NCT02377427|Secondary|Change From Baseline in Sitting SBP and DBP in Part A|Sitting blood pressure measurements were performed in Part A at indicated time points. Measurements were done pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4, 8, 9, 12, 16 and 20|Safety Population|||mmHg||Standard Deviation|Mean
1316971|NCT02377427|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies Response in Part A|Blood sample for immunogenicity was collected for anti-mepolizumab binding antibodies and neutralizing antibodies response in Part A at indicated time points prior to study treatment administration. Number of participants with positive anti-mepolizumab binding antibodies and neutralizing antibodies response was summarized. Participant was considered 'Positive' if they had at least one positive post-baseline assay result. Any Time Post Baseline has been presented, which included all visits (including scheduled and unscheduled) post-baseline was considered for this visit derivation. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 16 and 20|Safety Population|||Participants|||Number
1316972|NCT02377427|Secondary|Number of Participants With Abnormal Findings for Urinalysis in Part A|Urine samples were collected from participants at indicated time points for analysis of urinalysis parameters including specific gravity and pH of urine, presence of glucose, protein, blood and ketones in urine by dipstick test. Microscopic examination was performed if blood or protein was abnormal. Only those participants with data available at the specified time points were analyzed.|Up to Week 20|Safety Population|||Participants|||Number
1316973|NCT02377427|Secondary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Clinical Chemistry Parameters in Part A|"Blood samples were collected for analysis of ALT, ALP, AST, GGT, albumin, protein, total billirubin, creatinine, direct billirubin, urate, calcium, CO2, chloride, glucose, potassium, sodium and urea. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Any time post Baseline = all visits (including scheduled and unscheduled) post Baseline was considered for this visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Any Time Post-Baseline values have been presented."|Baseline and up to Week 20|Safety Population|||Participants|||Number
1317817|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population||24 hours||||mean number of tablets taken||Standard Deviation|Mean
1316974|NCT02377427|Secondary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Hematology Parameters in Part A|"Blood samples were collected for analysis of basophils, eosinophils, leukocyte, monocyte, neutrophils, lymphocyte, platelet count, MCH, MCHC, Hgb, MCV, erythrocytes, hematocrit, and Ret/Ery. The Baseline was the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Any time post Baseline = all visits (scheduled and unscheduled) post Baseline was considered for this visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Any Time Post-Baseline values have been presented."|Baseline and up to Week 20|Safety Population|||Participants|||Number
1316975|NCT02377427|Secondary|Number of Participants With on Treatment SAEs and Non-SAEs in Part A|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any on-treatment non-SAE or SAE (defined as events occurring from the first dose until 28 days after the last dose of mepolizumab) were considered for analysis.|Up to Week 20|Safety Population|||Participants|||Number
1316976|NCT02377427|Secondary|Change From Baseline in C-ACT at Weeks 4,8,16 and 20 in Part A|The C-ACT assesses asthma control in children 4-11 years of age. The C-ACT is a 7-question, 2-part questionnaire, with items 1 to 4 were completed by the child (with assistance from a caregiver, as needed) and items 5 to 7 were completed by the caregiver. A total sum score based upon responses to all items was calculated to provide an overall measure of asthma control. The derived C-ACT score ranges from 0 (maximum impairment) to 27 (no impairment), where higher scores represent a better outcome. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at the indicated time point minus Baseline Score. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4,8,16 and 20|PDo Population|||Scores on a scale||Standard Deviation|Mean
1316977|NCT02377427|Secondary|Change From Baseline in Childhood Asthma Control Test (C-ACT) at Week 12 for Part A|The C-ACT assesses asthma control in children 4-11 years of age. The C-ACT is a 7-question, 2-part questionnaire, with items 1 to 4 were completed by the child (with assistance from a caregiver, as needed) and items 5 to 7 were completed by the caregiver. A total sum score based upon responses to all items was calculated to provide an overall measure of asthma control. The derived C-ACT score ranges from 0 (maximum impairment) to 27 (no impairment), where higher scores represent a better outcome. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at Week 12 minus Baseline Score.|Baseline and Week 12|PDo Population. Only those participants with data available at specific time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1316978|NCT02377427|Secondary|Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Weeks 4,8,16 and 20 in Part A|ACQ-7 is a simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or a result of treatment. The ACQ-7 uses a 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7=category for FEV1%). The instrument has a reported high test-retest reproducibility with an intraclass correlation coefficient =0.90. The minimally important change in score is 0.5. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at the indicated time point minus Baseline Score. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4,8,16 and 20|PDo Population|||Scores on a scale||Standard Deviation|Mean
1316979|NCT02377427|Secondary|Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Week 12 in Part A|ACQ-7 is a simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or a result of treatment. The ACQ-7 uses a 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 = category for forced expiratory volume in 1 second [FEV1]%). The instrument has a reported high test-retest reproducibility with an intraclass correlation coefficient =0.90. The minimally important change in score is 0.5. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at Week 12 minus Baseline Score. Pharmacodynamic Outcome (PDo) Population included all participants who received at least one dose of mepolizumab beginning at Visit 2 and having at least one Part A assessment of pharmacodynamic outcomes.|Baseline and Week 12|PDo Population. Only those participants with data available at specific time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
1316980|NCT02377427|Secondary|Body Weight-adjusted Apparent Clearance of Mepolizumab for Part A|PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. The body weight-adjusted apparent clearance was compared between adults and participants aged 6 to 11 years old with severe eosinophilic asthma when mepolizumab was administered subcutaneously. Point estimate and 90% confidence interval (CI) for participants aged 6 to 11 years (centered to a mean bodyweight of 70 kg) was compared with the historic adult estimated body-weight adjusted clearance of 0.22 L/day, around which a proposed 80-125% interval was applied i.e. 0.18-0.28 L/day. Assuming an absolute bioavailability of 75% this corresponds to an apparent clearance of 0.29 L/day with the proposed 80% to 125% interval of 0.23 to 0.36 L/day. Note the average bodyweight of 70kg (mean body weight observed in adults) was not observed in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||L/day||90% Confidence Interval|Mean
1317008|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - This telemedicine approach eases the travel burden for participation in clinical trials for patients."|6 months||||Participants|||Count of Participants
1316981|NCT02377427|Primary|Number of Participants With Abnormal Findings for Urinalysis Parameters in Part B|Urine samples were collected from participants at indicated time points for analysis of urinalysis parameters including Specific gravity and potential of hydrogen (pH) of urine, presence of glucose, protein, blood and ketones in urine by dipstick test. Microscopic examination was performed if blood or protein was abnormal. Only those participants with data available at the specified time points were analyzed.|From Week 20 and up to Week 72|Safety Population|||Participants|||Number
1316982|NCT02377427|Primary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Hematology Parameters for Part B|"Blood samples were collected for analysis of basophils, eosinophils, leukocyte, monocyte, neutrophils, lymphocyte, platelets, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), hemoglobin (Hgb), mean corpuscular volume (MCV), erythrocytes, hematocrit, and reticulocytes/erythrocytes (Ret/Ery). Baseline was defined as the latest value recorded prior to first dose of mepolizumab in Part A. Change from Baseline was defined as value at indicated time point minus Baseline value. All Part B visits (scheduled and unscheduled) post-Baseline were considered for Any-time Post-Baseline visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Any Time Post-Baseline values have been presented."|Baseline, from Week 20 and up to Week 80|Safety Population|||Participants|||Number
1316983|NCT02377427|Primary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Clinical Chemistry Parameters for Part B|"Blood samples were collected for analysis of alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), albumin, protein, bilirubin, creatinine, urate, direct bilirubin, calcium, carbon dioxide (CO2), chloride, glucose, potassium, sodium and urea. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab in Part A. Change from Baseline was defined as value at indicated time point minus Baseline value. All Part B visits (scheduled and unscheduled) post-Baseline were considered for Any-time Post-Baseline visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Any Time Post-Baseline values have been presented."|Baseline, from Week 20 and up to Week 72|Safety Population|||Participants|||Number
1316984|NCT02377427|Primary|Change From Baseline in Sitting Pulse Rate for Part B|Sitting pulse rate measurements were performed pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab in Part A. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 80|Safety Population|||Beats per minute||Standard Deviation|Mean
1316985|NCT02377427|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part B|Sitting blood pressure measurements included SBP and DBP. Measurements were done pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 80|Safety Population|||Millimeter of mercury||Standard Deviation|Mean
1316986|NCT02377427|Primary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies Response for Part B|Blood sample were collected for the determination of anti-mepolizumab binding antibodies and neutralizing antibodies response in Part B at Weeks 44, 68 and 80 prior to study treatment administration. Participant was considered 'Positive' if they had at least one positive post-Baseline anti-drug antibody assay result. All Part B visits (including scheduled and unscheduled) post-Baseline were considered for Any-time Post-Baseline visit derivation. The number of participants with positive anti-mepolizumab binding antibodies and neutralizing antibodies response at Any Time Post Baseline has been presented. The neutralizing antibodies response results only presented for participants with positive anti-drug antibody assay.|From Week 20 and up to Week 80|Safety Population|||Participants|||Number
1316987|NCT02377427|Primary|Number of Participants With on Treatment Serious Adverse Events (SAEs) and Non-SAEs for Part B|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia are to be categorized as SAE. On-treatment SAEs and non-SAEs are defined as events occurring from the first Part B dose until 28 days following the last Part B dose. Safety Population includes all participants who received at least one dose of mepolizumab beginning at Visit 9.|From Week 20 and up to Week 72|Safety Population|||Participants|||Number
1316988|NCT02377427|Primary|Ratio to Baseline in Absolute Blood Eosinophil Count at Week 12 for Part A|PD of mepolizumab was evaluated in participants using ratio to Baseline in absolute blood eosinophil count. Blood samples were collected at indicated time points. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Ratio to Baseline was calculated as post-dose visit value/Baseline value. It was evaluated by Pharmacodynamic Eosinophils (PDe) Population which included all participants receiving at least one dose of mepolizumab beginning at Visit 2 (Week 0) and having at least one Part A blood sample evaluable for blood eosinophil count.|Baseline and Week 12|PDe Population. Only those participants with data available at specific time point were analyzed.|||Ratio of eosinophils in blood||95% Confidence Interval|Geometric Mean
1317009|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I found it easy to use the telemonitoring tablet computer."|6 months||||Participants|||Count of Participants
1316989|NCT02377427|Primary|Plasma Apparent Clearance (CL/F) of Mepolizumab in Part A|PK of mepolizumab was evaluated in participants using CL/F. PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. CL was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70kg (mean body weight observed in adults) was not investigated in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Liter (L) per day||Standard Error|Mean
1316990|NCT02377427|Primary|Terminal Phase Elimination Half-life (T1/2) of Mepolizumab During Treatment Period for Part A|PK of mepolizumab was evaluated in participants using t1/2. PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. T1/2 was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70kg (mean body weight observed in adults) was not investigated in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Days||Standard Error|Mean
1316991|NCT02377427|Primary|Area Under Concentration Time Curve to Infinity (AUC [0-inf]) of Mepolizumab for Part A|PK of mepolizumab was evaluated in participants using AUC (0-inf). PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. AUC (0-inf) was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70kg (mean body weight observed in adults) was not investigated in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Day*ug per mL||Standard Error|Mean
1316992|NCT02377427|Primary|Maximum Plasma Concentration (Cmax) of Mepolizumab for Part A|PK of mepolizumab was evaluated in participants using Cmax. PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. Cmax was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70 kg (mean body weight observed in adults) was not investigated in the study. PK Population included all participants receiving at least one dose of mepolizumab beginning at Visit 2 (Week 0) and having at least one blood sample taken at Visit 3 (Week 4) or thereafter with measurable mepolizumab plasma concentration.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Microgram (ug) per mL||Standard Error|Mean
1316993|NCT02376998|Primary|Number of Participants With Major Adverse Events|Evaluation of mortality, renal failure, cerebrovascular accident.|from hospital discharge to 1 month after the procedure|No serious adverse events recorded|||number of serious adverse events|||Number
1316994|NCT02376530|Primary|Nutritional Quality of Food Purchases|The Overall Nutrient Quality Index (ONQI) was used to assess nutritional quality of foods purchased. The ONQI is a 1 - 100 scale in which higher numbers indicate higher nutritional quality. Each food is given a score based on a ratio with positive health nutrients in the numerator and detrimental health nutrients in the denominator, based on a proprietary algorithm created by NuVal. The average ONQI score for all the groceries purchases was used as the outcome measure, of ONQI scores on a scale.|Participants were followed for one shopping session, an average of 2.5 hours|Data was analyzed for 781 participants. Two participants did not understand the study, 2 participants had incorrect price manipulations during their session, 1 participant was ill during the session, 1 participant had her young daughter in the room during the experiment and 1 participant did not have a household to shop for.|||Average NUVAL Score||Standard Deviation|Least Squares Mean
1316995|NCT02376166|Secondary|Episodes of Vomiting|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 6th reported outcome - Number of episodes of vomiting|6 months||||episodes|||Number
1316996|NCT02376166|Secondary|Episodes of Nausea|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 5th reported outcome - Number of episodes of nausea|6 months||||episodes|||Number
1316997|NCT02376166|Secondary|Episodes of Bloating|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 4th reported outcome - Number of episodes of bloating|6 months||||episodes|||Number
1316998|NCT02376166|Secondary|Episodes of Flatulence|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 3rd reported outcome - Number of episodes of flatulence|6 months||||episodes|||Number
1316999|NCT02376166|Secondary|Episodes of Watery Bowel Movements|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 2st reported outcome - Number of episodes of watery bowel movements|6 months||||episodes|||Number
1317000|NCT02376166|Secondary|Increased Frequency of Bowel Movements|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of Increased frequency of bowel movements|6 months||||episodes|||Number
1317001|NCT02376166|Secondary|Urgency to Have a Bowel Movement Episodes|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of urgency to have a bowel movement|6 months||||episodes|||Number
1317002|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I felt that I was able to communicate well with the study team, even though most contact was through the tablet computer video instead of in person."|6 months||||Participants|||Count of Participants
1317003|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would participate in a clinical trial where the entire trial was conducted remotely without requiring any visits to the study center."|6 months||||Participants|||Count of Participants
1317004|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would recommend participation in a telemedicine clinical trial to other patients."|6 months||||Participants|||Count of Participants
1317005|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I felt I was monitored sufficiently closely while enrolled in this trial."|6 months||||Participants|||Count of Participants
1317010|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - Participation in this trial did not disrupt my work or other activities."|6 months||||Participants|||Count of Participants
1317011|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - The time commitment required for participation in this trial was not overly burdensome."|6 months||||Participants|||Count of Participants
1317012|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would participate in a telemedicine clinical trial in the future."|6 months||||Participants|||Count of Participants
1317013|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would participate in a clinical trial in the future."|6 months|2 patients did not complete the questionnaire|||Participants|||Count of Participants
1317014|NCT02376166|Secondary|Adherence With Metformin as Measured by Electronic Pill Adherence Monitoring|Adherence with metformin as measured by electronic pill adherence monitoring. Patients were provided with an electronic medication dispenser/medication adherence monitoring device. The device provided audible and visual reminders to proceed with drug dosing and was equipped with a cellular modem that registers a signal to a cloud-based database each time a patient accessed his or her study medication. However, the size and shape of the metformin pills caused the device to malfunction frequently, which led patients to access the pills from the device manually; the data, therefore, could not be used for analysis.|6 months|||||||
1317015|NCT02376166|Secondary|Percentage of Participants With Stable PSA Levels at 6 Months as Defined by a <20% Change|Percent of patients with 6-month PSA stable 20% change at 6 months as compared to baseline|baseline and 6 month||||Participants|||Count of Participants
1317016|NCT02376166|Primary|Number of Participants That Completed All Telemedicine Visits|Feasibility will be defined as completion of all telemedicine visits by > 2/3 of enrolled patients (unless treatment discontinued early for toxicity or disease progression).|6 months||||Participants|||Count of Participants
1317017|NCT02375971|Secondary|Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169|Blood Pressure measurements were not required by the protocol. Instead, the most recent Systolic and Diastolic Blood Pressure expressed in millimeters of mercury (mmHg) measured as part of the routine clinical care were used. Only descriptive analysis done.|Baseline, Day 85, Day 169|The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1317018|NCT02375971|Secondary|Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169|Body weight was measured. Only descriptive analysis done.|Baseline, Day 85, Day 169|The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.|||gram (g)||Standard Deviation|Mean
1317019|NCT02375971|Secondary|Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169|Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done.|Baseline, Day 85, Day 169|The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.|||centimeter (cm)||Standard Deviation|Mean
1317020|NCT02375971|Secondary|Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24|Percent of Participants with Non-Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.|Week 24|The Safety Set was considered.|||Percent of participants|||Number
1317021|NCT02375971|Secondary|Total Number of Ranibizumab Injections Received at Week 24|Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done.|Week 24|The Safety Set was considered.|||Injections|||Number
1317022|NCT02375971|Secondary|Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29|Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first investigational treatment, at Day 15 and at Day 29. Only descriptive analysis done.|Day 1 (Baseline), Day 15 and Day 29|The VEGF Set, which consisted of all participants with at least one valid VEGF concentration value, was considered.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1317023|NCT02375971|Secondary|Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29|Blood samples for the determination of ranibizumab concentrations were collected in the Ranibizumab treatment arms only at the following time points: within 24 hours after the first administration of ranibizumab, at Day 15 and at Day 29. Only descriptive analysis done.|Day 1 (Baseline), Day 15 and Day 29|The PK Set, which consisted of all participants with at least one valid PK concentration value, was considered.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1317024|NCT02375971|Secondary|Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24|Percent of Participants with Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.|Week 24|The Safety Set was considered.|||Percent of participants|||Number
1317025|NCT02375971|Secondary|Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24|Recurrence of ROP is defined as subjects receiving any post-baseline intervention in either eye at or before 24 weeks (ranibizumab re-treatment or switch to laser in the ranibizumab groups, switch to ranibizumab treatment in the laser group). Zone I consists of a circle, the radius of which extends from the center of the optic disc to twice the distance from the center of the optic disc to the center of the macula. Zone II extends centrifugally from the edge of zone I to the nasal ora serrata. Only descriptive analysis done.|Week 24|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants|||Number
1329606|NCT02107014|Primary|Change in IL-18 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1317026|NCT02375971|Secondary|Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit|An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done.|Day 1 (after initiation of study treatment) up to study exit (Day 169)|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Participants|||Number
1317027|NCT02375971|Secondary|Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24|Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done.|Week 24|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants|||Number
1317028|NCT02375971|Primary|Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24|To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.|Week 24|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of Participants|||Number
1317029|NCT02375724|Secondary|Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8|The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life|Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product LCQ data were available for 126/135 patients receiving aclidinium and 128/134 receiving placebo|||Score||Standard Error|Least Squares Mean
1317030|NCT02375724|Secondary|Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period|The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms|Baseline to Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo|||Score||Standard Error|Least Squares Mean
1317031|NCT02375724|Primary|Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period|The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms|Baseline to Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo|||Score||Standard Error|Least Squares Mean
1317032|NCT02375373|Primary|Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.|Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.|Change from Day 31, Day 62, and Day 93|Due to the rate of withdrawal from this study only one participant completed and this data was used for the outcome measures.|||sequences||97.5% Confidence Interval|Mean
1317033|NCT02375347|Primary|Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.|"Compare the gut microbiota composition and overall diversity of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products, using 16S ribosomal RNA (rRNA) sequencing of fecal samples.~The use of Operational Taxonomic Units (OTUs) are used to classify clusters of similar bacterial groups. OTUs are species or group of species often used when only DNA sequence data is available.~This measure is the average amount of OTUs found for each time point."|Change in Baseline (Day 1, Day 7-9, and Day 14)||||Avg. Operational Taxonomic Units||Standard Error|Mean
1317034|NCT02374593|Secondary|Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls|Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results|6 months||||dose adjustments||Standard Error|Mean
1317035|NCT02374593|Primary|Dose Adjustments|Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.|6 months||||Number of dose adjustments||Standard Error|Mean
1317036|NCT02374398|Secondary|Adverse Events|Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA)|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||participants|||Number
1317037|NCT02374398|Secondary|Cost Analysis|Charges per case.|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||Dollars||Standard Deviation|Mean
1317038|NCT02374398|Secondary|Post Operative Blood Loss|"The estimated blood loss was determined with the Gross formula [23]. According to a review article published in 2013, Gross’s formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below:~Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV [Hematocritinitial – Hematocritfinal ] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two."|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||ml||Standard Deviation|Mean
1317818|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population||Cumulative through 12 hours||||mean number of tablets taken||Standard Deviation|Mean
1317039|NCT02374398|Primary|The Change in Hematocrit (Ht) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.~iv TXA plus regular electrocautery.~iv placebo plus Aquamantys system and regular electrocautery.~iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||Volume % of RBC in blood||Standard Deviation|Mean
1317040|NCT02374398|Primary|The Change in Hemoglobin (Hb) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.~iv TXA plus regular electrocautery.~iv placebo plus Aquamantys system and regular electrocautery.~iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||g/dl||Standard Deviation|Mean
1317041|NCT02374346|Secondary|Factors Associated With Postoperative Headache|Demographic, anaesthetic and surgical factors associated with postoperative headache|6 months||||participants|||Number
1317042|NCT02374346|Primary|Frequency of Postoperative Headache in Elective Surgery Patients|The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.|6 months|"Frequency of postoperative headache in total sample (n=446), Post-op Headache, no History of Headache (n=229), Post-op Headache, History of Headache (n=217), where n= number of participants analyzed"|||participants|||Number
1317043|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 40 mg (Regimen B) and Febuxostate XR 80 mg (Regimen C) in Fasted States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.|||ng*hr/mL||Standard Deviation|Mean
1317044|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.|||ng*hr/mL||Standard Deviation|Mean
1317045|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUCt) Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.|||ng*hr/mL||Standard Deviation|Mean
1317046|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.|||ng*hr/mL||Standard Deviation|Mean
1317047|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple time points (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration who received a single dose of study drug in Regimen B and C.|||ng/mL||Standard Deviation|Mean
1317048|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the Pharmacokinetic population (PK), all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.|||ng/mL||Standard Deviation|Mean
1317049|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters|"Criteria for potentially clinically significant abnormalities:~Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Alkaline phosphatase: >1.5 ULN~Total bilirubin (TBILI): >1.5 ULN; >2 ULN~Conjugated bilirubin(CBILI): >1.5 ULN~Unconjugated bilirubin: >1.5 ULN~ALT >3 ULN and TBILI >2 ULN~CBILI >35% TBILI and TBILI >1.5 ULN~Albumin: <=25 g/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317050|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters|"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline~Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min~Blood urea nitrogen: >=17 mmol/L~Uric acid: <120 micromol/L; >408 micromol/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317051|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes|"Criteria for potentially clinically significant abnormalities:~Sodium: <=129 mmol/L; >=160 mmol/L~Potassium: <3 mmol/L; >=5.5 mmol/L~Chloride: <80 mmol/L; >115 mmol/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317052|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters|"Criteria for potentially clinically significant abnormalities:~Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas])~Hemoglobin A1c (HbA1c): >8%~Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L~LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L~Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317053|NCT02373202|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52|HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.|Baseline, Week 52|mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1317054|NCT02373202|Secondary|Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)|DAS28-CRP is a composite score that contains 4 variables: TJC (based on 28 joints), SJC (based on 28 joints), participant’s assessment of general health on VAS (range 0 [very well] to 100 mm [extremely bad]) and CRP (mg/L). DAS28-CRP total score ranges from 2-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas below 3.2 indicates low disease activity and below 2.6 as disease remission.|Baseline, Week 52|mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here ‘Overall Number of Participants Analyzed’ signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1317055|NCT02373202|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52|ACR response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by Health Assessment Question-Disability Index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20/50/70 response is defined as at least 20/50/70% improvement in both TJC and SJC, and at least 20/50/70% improvement in at least 3 of the 5 other assessments, respectively.|Week 52|mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures.|||percentage of participants|||Number
1317056|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters|"Criteria for potentially clinically significant abnormalities:~Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L~Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)~Red blood cells (RBC): >=6 Tera/L~Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L~White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L~Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L~Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and <lower limit of normal (LLN); >4.0 Giga/L~Monocytes: >0.7 Giga/L~Basophils: >0.1 Giga/L~Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317057|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities|"Criteria for potentially clinically significant ECG abnormalities:~PR Interval: >200 milliseconds (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%~QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%~QT Interval: >500 ms~QTc Bazett (QTc B): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms, IFB >60 ms~QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317058|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities|"Criteria for potentially clinically significant vital sign abnormalities:~Systolic blood pressure (SBP) supine: <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg~Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB ≥10 mmHg~SBP (Orthostatic): <=-20 mmHg~DBP (Orthostatic): <=-10 mmHg~Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm~Weight: >=5% DFB; >=5% IFB"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317070|NCT02372097|Secondary|Tmax: Time to Reach the Cmax for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||hour(hr)||Full Range|Median
1317059|NCT02373202|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. TEAEs included both SAEs and non-SAEs.|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
1317060|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (AUC0-72) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to 72 hours [AUC0-72]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.|||mg⋅h/mL||Geometric Coefficient of Variation|Geometric Mean
1317061|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (Cmax) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (maximum plasma concentration [Cmax]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.|||microgram/millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317062|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on Pharmacokinetics (PK; AUC) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to infinity [AUC]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.|||milligram x hour /millilitre (mg⋅h/mL)||Geometric Coefficient of Variation|Geometric Mean
1317063|NCT02372097|Secondary|Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|Baseline up to 7 days after the last dose of study drug (Day 8) in each period|The safety analysis set included all participants who received study drug.|||participants|||Number
1317064|NCT02372097|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
1317065|NCT02372097|Secondary|Number of Participants With TEAEs Related to Body Weight||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
1317066|NCT02372097|Secondary|Number of Participants With TEAEs Related to Vital Signs||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
1317067|NCT02372097|Secondary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)|Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29).|Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
1317068|NCT02372097|Secondary|Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||per hour(hr-1)||Standard Deviation|Geometric Mean
1317069|NCT02372097|Secondary|MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||hr||Standard Deviation|Geometric Mean
1322353|NCT02246673|Secondary|Apparent Terminal Half-life (t1/2)|t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||hr||95% Confidence Interval|Geometric Mean
1317071|NCT02372097|Secondary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317072|NCT02372097|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||nanogram per milliliter(ng/mL)||Standard Deviation|Geometric Mean
1317073|NCT02372097|Primary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||nanogram hour per milliliter(ng*hr/mL)||Standard Deviation|Geometric Mean
1317074|NCT02372071|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)||||mg/dL||Standard Deviation|Mean
1317075|NCT02372058|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)||||mg/dL||Standard Deviation|Mean
1317076|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'No Answer or Not Applicable'. The percents (of subjects who responded) that were 'Strongly Agree','Agree','Neutral' about views/behaviors related to self-monitoring blood glucose were calculated.|1 hour|Percent (of those who responded) who 'Strongly Agree', 'Agree', 'Neutral' was calculated for each statement. Abbreviations used: 'HCP' is HealthCare Professional and 'Acc' is Accuracy|||Percentage of Participants Who Responded|||Number
1317077|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree','Agree','Neutral' about each statement was calculated.|1 hour||||Percentage of Participants Who Responded|||Number
1317078|NCT02371876|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) and +/- 12.5% (>= 100mg/dL YSI capillary plasma).|1 hour||||Percentage of BG Results|||Number
1317079|NCT02371876|Secondary|Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI venous plasma) and +/- 15% (>= 100mg/dL YSI venous plasma).|1 hour|132 (134-2) Blood glucose results were analyzed. Venipunctures were unsuccessful for two subjects.|||Percentage of BG Results|||Number
1317080|NCT02371876|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour||||Percentage of BG Results|||Number
1317081|NCT02371876|Secondary|Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|126 (134-8) Blood glucose results were analyzed. Four subjects with low blood sugar did not attempt palm testing per protocol. Four subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percentage of BG Results|||Number
1317082|NCT02371876|Primary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour||||Percentage of BG Results|||Number
1317083|NCT02371850|Secondary|Area Under the Curve (AUC) Attained With and Without Heating in Each of the Two Nicotine Patches (Reference and Generic)|Area under the curve (AUC) attained with and without heating in each of the two nicotine patches (reference and generic).|Four procedure days for each participant|Data analysis completed for AUC (see below), but not yet for Tmax.|||ng*hr/ml||Standard Deviation|Mean
1329607|NCT02107014|Primary|Change in IL-17F From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1317084|NCT02371850|Primary|Measurement of Maximum Plasma Concentration (Cmax)|The main outcome measure of the study is the measurement of maximum plasma concentration (Cmax)|four procedure days for each participant|Ten adult smokers between 24 and 44 years of age at the time of enrollment completed the study. The clinical study was an single-group, open-label study. Each subject completed 4 study visits where in-vivo nicotine levels were measured using a reference patch (Nicoderm CQ) and a generic patch (Aveva)|||ng/ml||Standard Deviation|Mean
1317085|NCT02371759|Secondary|Local Postoperative Complications|Postoperative paresthesia by clinical examination|24 hours, 7 days||||Participants|||Count of Participants
1317086|NCT02371759|Secondary|Postoperative Analgesia|Number of participants who experienced postoperative pain, VAS, NRS|up to 24 hours after tooth extraction||||Participants|||Count of Participants
1317087|NCT02371759|Secondary|Width of Anesthetic Field After Maxillary Infiltration Anesthesia|Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.|Up to 10 minutes after injection of local anesthesia||||milimeters||Standard Deviation|Mean
1317088|NCT02371759|Secondary|Onset of Intraoral Local Anesthesia|Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection|Up to 10 minutes, until subjective feeling of soft tissue numbnes||||minutes||Standard Deviation|Mean
1317089|NCT02371759|Primary|Electrocardiogram at 20 Minutes|ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement|20th minute||||Participants|||Count of Participants
1317090|NCT02371759|Primary|Electrocardiogram at 15 Minutes|ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement|15th minute||||Participants|||Count of Participants
1317091|NCT02371759|Primary|Electrocardiogram at 10 Minutes|ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement|10th minute||||Participants|||Count of Participants
1317092|NCT02371759|Primary|Baseline Electrocardiogram||baseline, 0 minutes||||Participants|||Count of Participants
1317093|NCT02371759|Primary|Ceart Rate at 35 Minutes|Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement|35th minute||||beats per minute||Standard Deviation|Mean
1317094|NCT02371759|Primary|Heart Rate at 20 Minutes|Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement|20th minute||||beats per minute||Standard Deviation|Mean
1317095|NCT02371759|Primary|Heart Rate at 15 Minutes|Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement|15th minute||||beats per minute||Standard Deviation|Mean
1317096|NCT02371759|Primary|Heart Rate at 10 Minutes|Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement|10th minute||||beats per minute||Standard Deviation|Mean
1317097|NCT02371759|Primary|Baseline Values of Heart Rate||baseline, 0 minutes||||beats per minute||Standard Deviation|Mean
1317098|NCT02371759|Primary|Diastolic Blood Pressure at 35 Minutes|Diastolic blood pressure values 30 minutes after local anesthesia injection|35th minute||||milimeters of Hg||Standard Deviation|Mean
1317099|NCT02371759|Primary|Diastolic Blood Pressure at 20 Minutes|Diastolic blood pressure values 15 minutes after local anesthesia injection|20th minute||||milimeters of Hg||Standard Deviation|Mean
1317100|NCT02371759|Primary|Diastolic Blood Pressure at 15 Minutes|Diastolic blood pressure values 10 minutes after local anesthesia injection|15th minute||||milimeters of Hg||Standard Deviation|Mean
1317101|NCT02371759|Primary|Diastolic Blood Pressure at 10 Minutes|Diastolic blood pressure values 5 minutes after local anesthesia injection|10th minute||||milimeters of Hg||Standard Deviation|Mean
1317102|NCT02371759|Primary|Baseline Diastolic Blood Pressure||baseline, 0 minutes||||milimeters of Hg||Standard Deviation|Mean
1317103|NCT02371759|Primary|Systolic Blood Pressure at 35 Minutes|Systolic blood pressure values 30 minutes after local anesthesia injection|35th minute||||milimeters of Hg||Standard Deviation|Mean
1317104|NCT02371759|Primary|Systolic Blood Pressure at 20 Minutes|Systolic blood pressure values 15 minutes after local anesthesia injection|20th minute||||milimeters of Hg||Standard Deviation|Mean
1317105|NCT02371759|Primary|Systolic Blood Pressure at 15 Minutes|Systolic blood pressure values 10 minutes after local anesthesia injection|15th minute||||milimeters of Hg||Standard Deviation|Mean
1317106|NCT02371759|Primary|Systolic Blood Pressure at 10 Minutes|Systolic blood pressure values 5 minutes after local anesthesia injection|10th minute||||milimeters of Hg||Standard Deviation|Mean
1317107|NCT02371759|Primary|Baseline Systolic Blood Pressure||Baseline, 0 minutes||||milimeters of Hg||Standard Deviation|Mean
1317108|NCT02371759|Primary|Intensity of Intraoral Local Anesthesia|"Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words no pain , while the other end is marked with 100 and words the worst pain imanginable. VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable. For both scales, higher scores represent worse outcomes."|Up to 10 minutes after local anesthesia injection||||Participants|||Count of Participants
1317109|NCT02371759|Primary|Duration of Intraoral Local Anesthesia|Time until cessation in soft tissue numbness|Up to 6 hours after local anesthesia injection||||minutes||Standard Deviation|Mean
1317110|NCT02371616|Secondary|Change From Baseline in Tactile Threshold at Week 4 and Week 8|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.|At Baseline, Week 4 and Week 8|Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.|||gram (g)||Standard Deviation|Mean
1317111|NCT02371616|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8|Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.|At Baseline, Week 4 and Week 8|Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.|||score on a scale||Standard Deviation|Mean
1317112|NCT02371616|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4|"Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth."|At Baseline and Week 4|Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.|||score on a scale||Standard Deviation|Mean
1317113|NCT02371616|Primary|Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8|"Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth."|At Baseline and Week 8|Analysis for this outcome was performed on per protocol (PP) population which is defined as all participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violations.|||score on a scale||Standard Deviation|Mean
1317114|NCT02370914|Primary|A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data|"Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Sensitivity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data~The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 >= 1.0 and R2 >= 0.66 and is considered non-concussed otherwise."|Individual assessments were made within 2 days of recording|Analysis population includes all participants. Some of these participants were were declared concussed by the physician in the team during the course of the season. All baseline recordings were treated as from non-concussed participants.|||percentage of concussed participants||95% Confidence Interval|Number
1317115|NCT02370667|Secondary|Change in Inflammatory Markers (CRP)|C-reactive protein (CRP) is an important marker of the inflammatory response. This markers will be assessed using standard blood draw and nasal swabs collected by a medical professional. The mean (95% confidence interval) difference in concentration in ug/ml (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in ug/ml||95% Confidence Interval|Mean
1317116|NCT02370667|Secondary|Change in Inflammatory Markers (IL6, TNF, IL10)|Cytokines interleukin-6 (IL6), tumour necrosis factor (TNF), and interleukin-10 (IL10) are important markers of the inflammatory response. These markers will be assessed using standard blood draw and nasal swabs collected by a medical professional. The mean (95% confidence interval) difference in concentration in pg/ml (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|For IL10: n=6 (BE), n=8 (TE), n=6 (M)|||Change in pg/ml||95% Confidence Interval|Mean
1317117|NCT02370667|Secondary|Change in Cartilage Morphology|Cartilage morphology will be assessed in open-sourced and custom programs. Sodium (23Na+) images and T2 mapping will be completed on the 3.0T MR750 DIscovery research-grade scanner. The mean (95% confidence interval) percent change from baseline to follow-up was computed for each of the three study arms.|Week 1 and Week 13||||% Change from Baseline to Follow-up||95% Confidence Interval|Mean
1317118|NCT02370667|Secondary|Change in Muscle and Fat Volume|Muscle and fat volumes from magnetic resonance images will be segmented using a custom program. The images will be acquired using a • Iterative Decomposition of water and fat with Echo Asymmetry and Least-squares estimation (IDEAL) sequence on a 3.0T MR750 Discovery research-grade scanner.|Indented to be collected on week 1 and week 13|Data for this outcome measure were not collected.||||||
1317119|NCT02370667|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the YMCA submaximal cycle ergometry test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor) and load (Watts).|Intended to be collected on week 1 and week 13|Data for this outcome measure were not collected.||||||
1317120|NCT02370667|Secondary|Change in Grip Strength (Relative)|Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg/kg (grip force/body mass). The mean (95% confidence interval) difference in relative force (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|Note: only 9 participants were analyzed for the Left Side|||Change in kg/kg||95% Confidence Interval|Mean
1317522|NCT02361736|Primary|Concentration of IL-18 in Urine on 5 Time Point|IL-18 is mainly created from proximal kidney tubules which is a proinflammatory factor that can be detected in earlier urine of AKI animal models.|-1d, 0d, 1d, 3d, 5d after surgery||||μg/L||Standard Deviation|Mean
1317121|NCT02370667|Secondary|Change in Grip Strength (Absolute)|Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg. The mean (95% confidence interval) difference in absolute force (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|Note: only 9 participants were analyzed for the Left Side|||Change in kg||95% Confidence Interval|Mean
1317122|NCT02370667|Secondary|Change in Isokinetic Knee Extensor and Flexor Power|The peak isokinetic torque developed during knee extension and flexion at 25% resistance of their maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in power (follow-up - baseline) was computed for each of the three study arms. Data is expressed in W/kg.|Week 1 and Week 13|One participant in TE did not complete the power evaluation.|||Change in W/kg||95% Confidence Interval|Mean
1317123|NCT02370667|Secondary|Change in Isometric Knee Extensor and Flexor Strength|The peak torque developed during knee extension and flexion during a maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in torque (follow-up - baseline) was computed for each of the three study arms. Data is presented as Nm/kg.|Week 1 and Week 13||||Change in Nm/kg||95% Confidence Interval|Mean
1317124|NCT02370667|Secondary|Change in Mobility Performance (Stair Ascent)|Mobility performance was measured using the Stair Ascent Test. For this test, the time taken to ascent nine stairs is recorded. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in seconds||95% Confidence Interval|Mean
1317125|NCT02370667|Secondary|Change in Mobility Performance (Timed Up and Go Test)|Mobility performance was measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3m, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in seconds||95% Confidence Interval|Mean
1317126|NCT02370667|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance was measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in number (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in number of sit-to-stand cycles||95% Confidence Interval|Mean
1317127|NCT02370667|Secondary|Change in Mobility Performance (40m Walk Test)|Mobility performance was measured using the 40m Walk Test. This test measures the time taken to complete a fast-paced 40m walk. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in seconds||95% Confidence Interval|Mean
1317128|NCT02370667|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance was measured using the Six-Minute Walk Test. For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in distance in metres (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in metres||95% Confidence Interval|Mean
1317129|NCT02370667|Secondary|Change in Frailty Status|Frailty was assessed using the Edmonton Frail Scale (EFS). The EFS is a brief screening interview for older adults to assess frailty that is commonly used in both inpatient and outpatient settings. The scale covers 8 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance (defined as performance on the Timed Up and Go [TUG] test). The test is scored out of 17, with higher scores indicating higher levels of frailty. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||Full Range|Mean
1317130|NCT02370667|Secondary|Change in Depression Status|Depression was assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. The CES-D is scored from 0 to 60 with a score of 16 or higher indicating depression. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
1317131|NCT02370667|Secondary|Change in Arthritis-related Self-efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Higher numbers indicate greater certainty that a participant can cope with a particular task as a consequence of their disease. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
1317132|NCT02370667|Secondary|Change in Self-reported Knee Pain|Change in self-reported knee pain was assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and the Numeric Pain Rating Scale (NPRS). The KOOS pain score represents a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The NPRS pain score represents a score from 0 (no pain) to 10 (worst possible pain). NPRS ratings were provided following maximum isometric knee extensor exertions and flexor exertions. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
1317880|NCT02354599|Primary|Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
1317133|NCT02370667|Primary|Change in Lower Extremity Function|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. The LEFS is scored from 0 to 80 with higher scores represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
1317134|NCT02370615|Primary|Number of Participants With Clinically Significant Change From Baseline in Continuous Pulse Oximetry (SpO2) in Cohort 2||Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
1317135|NCT02370615|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
1317136|NCT02370615|Primary|Number of Participants Who Had Clinically Significant Changes From Baseline in 12-lead Electrocardiograms|Number of participants who had ECG findings changed from “within normal limit” or “abnormal, clinically significant” to “abnormal and clinically significant” after study drug administration.|Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
1317137|NCT02370615|Primary|Number of Participants With TEAEs Related to Body Weight||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
1317138|NCT02370615|Primary|Number of Participants With TEAEs Related to Vital Signs||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
1317139|NCT02370615|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
1317140|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317141|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317142|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Midazolam and 1’Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng/mL||Standard Deviation|Geometric Mean
1317143|NCT02370615|Primary|Urinary Excretion Ratio of Digoxin From 0 to 48 Hours Postdose in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1317144|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317145|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317146|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng/mL||Standard Deviation|Geometric Mean
1317147|NCT02370615|Primary|Cumulative Urinary Excretion Ratio of TAK 272F and TAK 272-M-I From 0 to 72 Hours Postdose in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1317881|NCT02354599|Primary|Number of Participants With TEAEs Related to Lung Functioning Monitoring||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
1317148|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317149|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1317150|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for TAK 272F and TAK 272-Metabolite (M-I) in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1317151|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data is not available for the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
1317152|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data was not available for participants in the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
1317153|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
1317154|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
1317155|NCT02370602|Secondary|Ratio of TAK-063 Metabolite M-I AUC( 0-24) to TAK-063 AUC (0-24)|AUC Ratio is the ratio of AUC values of the metabolite compared to the parent calculated by dividing AUC values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ratio||Standard Deviation|Mean
1317156|NCT02370602|Secondary|Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Ratio is the ratio of Cmax values of the metabolite compared to the parent calculated by dividing Cmax values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ratio||Standard Deviation|Mean
1317157|NCT02370602|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||liter/hour||Standard Deviation|Mean
1317158|NCT02370602|Secondary|Average Plasma Concentration on Day 1 (Cavg) for TAK-063 and TAK-063 Metabolite M-I|Cavg is the average plasma concentration on Day 1, calculated as AUC(0-24)/24.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
1317159|NCT02370602|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
1317160|NCT02370602|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
1317161|NCT02370602|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||hour||Standard Deviation|Mean
1317162|NCT02370602|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
1317163|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters|"The percentage of participants with any markedly abnormal standard 12-lead ECG measurements.~QTc - Bazett's Interval (msec) is ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec"|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
1317164|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study. BL=baseline. bpm=beats per minute.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
1317165|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
1317166|NCT02370602|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose of study drug (up to 46 days)|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
1317167|NCT02370602|Secondary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 23 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Data was not available for participants in the pilot cohort. Occupancy is reported for putamen only.|23 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis.|||Percent||Standard Deviation|Mean
1317168|NCT02370602|Primary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 3 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Occupancy is reported for putamen only.|3 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis..|||Percent||Standard Deviation|Mean
1317169|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.|||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
1317170|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1317171|NCT02370537|Primary|Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1317172|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.|||h*nanomole/mL (h*nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
1317188|NCT02370394|Secondary|The Readiness to Change Contemplation Ladder|One item measure to assess readiness to make changes to increase safety. This item was scored with a range from 0-10. 0=not prepared to change to 10=already changing. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to make changes to increase safety.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
1317173|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1317174|NCT02370537|Primary|Part B: Baseline Corrected Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) for Total Eicosapentaenoic Acid (EPA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The Pharmacokinetic (PK) Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.|||hours*mcg per millilitre (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317175|NCT02370537|Primary|Part A: Serum TG Level.|For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).|7 days after enrollment.|The Per Protocol Analysis Set included all enrolled patients without an important protocol deviation.|||millimole per litre (mmol/L)||Standard Deviation|Mean
1317176|NCT02370420|Secondary|Change in the Visual Analog Scale (VAS) (Global Pain)|"The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. The scale is most commonly anchored by no pain  (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10).~Only the final measures (at 24 weeks) are presented as part of the final analysis."|Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks||||cm||Standard Deviation|Mean
1317177|NCT02370420|Secondary|Change in the SF-12 Health Survey (Quality of Life)|"SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.~A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. The data obtained with the SF-12 has been developed, tested and validated by Quality Metric Incorporated.~Only the final measures (at 24 weeks) from the physical domain are presented as part of the final analysis."|Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks||||units on a scale||Standard Deviation|Mean
1317178|NCT02370420|Primary|Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect)|"The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It measures five items of pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68); thus, the total score range is 0-96. A higher value indicates a worst outcome.~Only the final measures (at 24 weeks) are presented as part of the final analysis."|Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks||||units on a scale||Standard Deviation|Mean
1317179|NCT02370407|Secondary|Workspace Range|Automatically recorded data on the Mimic DV trainer consisting of workspace range (cm, this is the widest range traveled by the 2 instruments, one in each hand), and number of peg drops|study duration||||cm||Standard Deviation|Mean
1317180|NCT02370407|Secondary|Time Spent Using Excessive Force|Automatically recorded data on the Mimic DV trainer (seconds)|study duration||||seconds||Standard Deviation|Mean
1317181|NCT02370407|Secondary|Instrument Collisions|Automatically recorded data on the Mimic DV trainer which records number of collisions|study duration||||number of events||Standard Deviation|Mean
1317182|NCT02370407|Secondary|Instrument Out of View|Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency|through study completion||||seconds||Standard Deviation|Mean
1317183|NCT02370407|Secondary|Economy of Motion on the Robotic Task|(cm, where lower measurements represent improved economy of motion). This measures how many cm the instruments traveled in order to accomplish the task|Study duration||||cm||Standard Deviation|Mean
1317184|NCT02370407|Primary|Time to Task Completion on the Laparoscopic Task|Time to task completion (seconds) on the laparoscopic task|1 day of practice||||seconds||Standard Deviation|Mean
1317185|NCT02370407|Primary|Global Rating Scale Score on the Robotic Task|A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 – 35.|Study duration||||units on a scale||Standard Deviation|Mean
1317186|NCT02370407|Primary|Global Rating Scale Score on the Laparoscopic Task|Global rating scale score on the laparoscopic task. A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 – 35.|Study duration||||units on a scale||Standard Deviation|Mean
1317187|NCT02370407|Primary|Time to Task Completion (Robotic Task)|Primary outcome will be time to task completion (seconds) on the robotic task|1 day of practice||||seconds||Standard Deviation|Mean
1317208|NCT02370121|Primary|Triglycerides (TGs)|The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
1317209|NCT02370121|Primary|Waist Circumference (WC)|The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.|Week 12|All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).|||cm||Standard Deviation|Mean
1317189|NCT02370394|Secondary|Motivation Scale|A 1-item measure, was modified to assess how ready they are to use treatment, resources, and/or support for any partner abuse. This item was scored with a range from 0-10. 0=not ready at all to 10=completely ready. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to use treatment, resources, or support for any partner abuse.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
1317190|NCT02370394|Primary|Effectiveness in Obtaining Resources Scale (EOR)|Assesses the women’s effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
1317191|NCT02370394|Primary|Safety Behavior Checklist (SBC)|Includes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
1317192|NCT02370394|Primary|Composite Abuse Scale (CAS)-CAS Victimization Total Score|A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
1317193|NCT02370121|Secondary|Area Under the Curve of Insulin (AUCI)|The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.|week 12||||pmol/L/min||Standard Deviation|Mean
1317194|NCT02370121|Secondary|Area Under the Curve of Glucose (AUCG)|The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.|week 12||||mmol/L/min||Standard Deviation|Mean
1317195|NCT02370121|Secondary|2-hour Postload Plasma Glucose (2-h PG)|The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
1317196|NCT02370121|Secondary|Very-low Density Lipoprotein (VLDL)|The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
1317197|NCT02370121|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)|The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.|Week 12||||mmol/L||Standard Deviation|Mean
1317198|NCT02370121|Secondary|Total Cholesterol (TC)|The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
1317199|NCT02370121|Secondary|Body Mass Index (BMI)|The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.|week 12||||kg/m^2||Standard Deviation|Mean
1317200|NCT02370121|Secondary|Body Weight (BW)|The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.|week 12||||kg||Standard Deviation|Mean
1317201|NCT02370121|Primary|Insulin Sensitivity|The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].|week 12||||unitless||Standard Deviation|Mean
1317202|NCT02370121|Primary|First Phase of Insulin Secretion|The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').|week 12||||unitless||Standard Deviation|Mean
1317203|NCT02370121|Primary|Total Insulin Secretion|The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).|Week 12||||unitless||Standard Deviation|Mean
1317204|NCT02370121|Primary|Diastolic Blood Pressure (DBP)|The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.|week 12||||mmHg||Standard Deviation|Mean
1317205|NCT02370121|Primary|Systolic Blood Pressure (SBP)|The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.|week 12||||mmHg||Standard Deviation|Mean
1317206|NCT02370121|Primary|Fasting Plasma Glucose (FPG)|The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
1317207|NCT02370121|Primary|High-density Lipoprotein Cholesterol (HDL-C)|The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.|Week 12||||mmol/L||Standard Deviation|Mean
1317210|NCT02369848|Secondary|Clinical Success|"Change in Rutherford Clinical Category from Baseline to 30 days~There are seven stages to condsider:~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene"|30 days||||change in Rutherford score from baseline||95% Confidence Interval|Mean
1317211|NCT02369848|Secondary|Clinical Success|"Change in Rutherford Clinical Category from Baseline to12 months.~There are seven stages to condsider:~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene"|12 months||||change in Rutherford score from baseline||95% Confidence Interval|Mean
1317212|NCT02369848|Secondary|Clinical Success|"Change in Rutherford Clinical Category at from Baseline to 6 months.~There are seven stages to consider:~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene"|6 months||||change in Rutherford score from baseline||95% Confidence Interval|Mean
1317213|NCT02369848|Secondary|Clinical Success - Improvement of Ankle-Brachial (ABI) of the Target Limb.|The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).|12 months||||Percent change in ABI from baseline||95% Confidence Interval|Mean
1317214|NCT02369848|Secondary|Clinical Success - Improvement of Ankle-Brachial Index (ABI) of the Target Limb.|The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).|6 months||||Percent change in ABI from baseline||95% Confidence Interval|Mean
1317215|NCT02369848|Secondary|Secondary Patency Measured by Number of Participants With Target Lesion Patency (Without Adjunctive PTA) by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.||12 months||||Participants|||Count of Participants
1317216|NCT02369848|Secondary|Secondary Patency Measured by Number of Participants With Target Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.||6 months||||Participants|||Count of Participants
1317217|NCT02369848|Secondary|Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants|"The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty (PTA) therapy) as assessed by quantitative angiography via core lab evaluation.~The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive PTA therapy) as assessed by quantitative angiography via core lab evaluation."|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted.|||Participants|||Count of Participants
1317218|NCT02369848|Secondary|Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)||12 months||||Participants|||Count of Participants
1317219|NCT02369848|Primary|Safety Endpoint Defined as Composite of New-onset Major Adverse Events (MAEs)|"Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion or distal to the treated lesion after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization.~Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting."|Within 30 days following procedure||||Participants|||Count of Participants
1317220|NCT02369848|Primary|Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis||12 months post-procedure|Data reflects number for participants who have an evaluable (diagnostic) scheduled or unscheduled duplex ultrasound based on reporting windows and slotting rules in the Statistical Plan. Thirty out of 43 participants achieved target lesion patency.|||Participants|||Count of Participants
1317221|NCT02369796|Secondary|Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.|||hr||Standard Deviation|Mean
1317222|NCT02369796|Secondary|AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.|||pg*hr/mL||Standard Deviation|Mean
1317223|NCT02369796|Secondary|AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F|AUC(0-∞) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.|||pg*hr/mL||Standard Deviation|Mean
1329608|NCT02107014|Primary|Change in IL-17A From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1317224|NCT02369796|Secondary|Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.|||pg/mL||Standard Deviation|Mean
1317225|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups|Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 25 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||nmol/L||Standard Deviation|Mean
1317226|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups|Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 22 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure. Number of participants analyzed is number of participants evaluated for this outcome measure.|||nmol/L||Standard Deviation|Mean
1317227|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group|Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 25 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||nmol/L||Standard Deviation|Mean
1317228|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups|Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 22 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||nmol/L||Standard Deviation|Mean
1317229|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups|Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
1317230|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups|Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
1317231|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups|Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
1317232|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups|Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
1317233|NCT02369510|Secondary|Incidence of Pruritus|data not collected|up to 3 hours|||||||
1317234|NCT02369510|Secondary|Incidence of Nausea and Vomiting||up to 3 hours||||Participants|||Count of Participants
1317235|NCT02369510|Secondary|Patient Satisfaction|"Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or completely satisfied."|up to 3 hours||||percentage of participants|||Number
1317236|NCT02369510|Secondary|Adequacy of Anesthesia|As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia.|up to 3 hrs||||units on a scale||Inter-Quartile Range|Median
1317237|NCT02369510|Secondary|Number of Participants With Hypotension|Incidence of hypotension as measured by participants needing vasopressor agents|at 2 minutes and at 25 minutes||||Participants|||Count of Participants
1317238|NCT02369510|Secondary|Block Onset|Time to a onset of T4 level of anesthesia or the highest level achieved in 15min|up to 15 min||||minutes||Inter-Quartile Range|Median
1317239|NCT02369510|Secondary|Motor Recovery|Time to Bromage 3 motor recovery|up to 4 hours||||minutes||95% Confidence Interval|Median
1317240|NCT02369510|Primary|Sensory Recovery|Time to T10 sensory recovery as measured by pinprick sensation|up to 3 hours||||minutes||95% Confidence Interval|Median
1317241|NCT02369341|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1317681|NCT02358668|Secondary|Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in systolic blood pressures from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmHg||Standard Deviation|Mean
1317242|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1317243|NCT02369341|Secondary|Duration of Solicited General Symptoms|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||days||Full Range|Median
1317244|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAE was defined as at least one MAE experienced. Grade 3 was defined as MAEs that prevented normal activities and related was defined as MAEs assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject).|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||subjects|||Number
1317245|NCT02369341|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||days||Full Range|Median
1317246|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were Arthralgia, Fatigue, Gastrointestinal symptoms, Headache, Myalgia, Shivering, Sweating and Temperature (Oral). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1317247|NCT02369341|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1317248|NCT02369341|Secondary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317249|NCT02369341|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317250|NCT02369341|Secondary|MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Mean
1317251|NCT02369341|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317261|NCT02368457|Primary|Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).|"Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).~Intraoral bone exposure is measured in mm2."|From baseline to 1, 3, 6, and 9 months of starting treatment|mean of intraoral bone exposure (measured in mm2) from baseline to 1, 3, 6, 9, 12 and 18 months of starting treatment|||mm2||Full Range|Mean
1317252|NCT02369341|Secondary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317253|NCT02369341|Secondary|Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.|Antibody titers were expressed as GMTs. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1317254|NCT02369341|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1317255|NCT02369341|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|"SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317256|NCT02369341|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317257|NCT02369341|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317258|NCT02369341|Primary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1317259|NCT02369341|Primary|Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1317260|NCT02368457|Secondary|Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale|"Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).~To examine the LENT/SOMA scale prospectively using interviews and questionnaires~Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.~Maximum score: 36 Minimum score: 0~Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.~Scale categories:~Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings."|From baseline to 1,3, 6, 9 months of starting treatment||||units on a scale||Full Range|Mean
1317282|NCT02367885|Secondary|GMT of SRH Antibody Titer (Vero Antigen)|GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
1317283|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||fold increase||95% Confidence Interval|Geometric Mean
1317284|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)|Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2), or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
1317285|NCT02367885|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2|Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
1317286|NCT02367885|Secondary|GMT of HI Antibody Titer (Vero Antigen)|GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
1317287|NCT02367885|Secondary|GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||fold increase||95% Confidence Interval|Geometric Mean
1317288|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)|Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
1317289|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40|Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
1317290|NCT02367885|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
1317291|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||fold increase||95% Confidence Interval|Geometric Mean
1317292|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2) or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
1317293|NCT02367885|Secondary|Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)|Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
1317294|NCT02367885|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|GMT of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in FAS (all participants who received at least 1 dose of study vaccination) who had available data for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
1317295|NCT02367885|Secondary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||fold increase||95% Confidence Interval|Geometric Mean
1317296|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
1317297|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
1317298|NCT02367885|Primary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||fold increase||95% Confidence Interval|Geometric Mean
1317299|NCT02367885|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years.|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||fold increase||95% Confidence Interval|Geometric Mean
1329609|NCT02107014|Primary|Change in IL-15 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1317300|NCT02367885|Primary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
1317301|NCT02367885|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
1317302|NCT02367885|Primary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
1317303|NCT02367885|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination)|All participants included in the full analysis set (FAS) (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
1317304|NCT02367885|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.|||participants|||Number
1317305|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.|||participants|||Number
1317306|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.|||participants|||Number
1317307|NCT02367872|Secondary|Number of Participants With TEAE Related to Laboratory Tests|"Number of participants with TEAE related to laboratory tests was reported in this outcome measure. The related event to report was only Alanine Aminotransferase Increased throughout this study."|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
1317308|NCT02367872|Secondary|Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECG)|Number of participants with TEAE related to ECG was reported in this outcome measure. There were no events to report as TEAE related to ECG throughout this study.|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
1317309|NCT02367872|Secondary|Number of Participants With TEAE Related to Body Weight|Number of participants with TEAE related to body weight was reported in this outcome measure. There were no events to report as TEAE related to body weight throughout this study.|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
1317310|NCT02367872|Secondary|Number of Participants With TEAE Related to Vital Signs|"Number of participants with TEAE related to vital signs was reported in this outcome measure. The related event to report was only Blood Pressure Decreased throughout this study."|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
1317311|NCT02367872|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
1317312|NCT02367872|Primary|Excretion Ratio of TAK-272F in Dialysate in Cohort 5R|Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant.|Day 1: Pre-dose, up to 6 hours post-dose|The dialysate PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for dialysate PK.|||percentage of dose||Standard Deviation|Mean
1317313|NCT02367872|Primary|Plasma Protein Binding Rate of TAK-272F in Cohorts 1R, 2R, 3R, 4R, 5R, 1H, 2H and 3H|Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein.|Baseline|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||% of unbound fraction of TAK-272F||Standard Deviation|Mean
1317314|NCT02367872|Primary|Cumulative Urinary Excretion Ratio of TAK-272F and Its Metabolite M-I From 0 to 72 Hours Post-dose in Cohorts 1R, 2R, 3R, 4R, 1H, 2H and 3H|Urinary excretion ratio (percentage [%] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant.|Day 1: Pre-dose and at multiple time points (4, 8, 12, 24, 36, 48, 72 hours post dose; up to 72 hours) post-dose|The urine PK analysis population where urinary excretion data on Day 1 was available. The urine PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for urine PK.|||percentage of dose||Standard Deviation|Mean
1317315|NCT02367872|Primary|CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for TAK-272F|CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||L/hr||Standard Deviation|Mean
1317316|NCT02367872|Primary|Apparent Clearance (CL/F) for TAK-272F||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||liter per hour (L/hr)||Standard Deviation|Mean
1317317|NCT02367872|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||hour||Full Range|Median
1317318|NCT02367872|Primary|AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F|AUC∞,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to infinity of TAK-272.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317319|NCT02367872|Primary|Cmax,u: Maximum Unbound Plasma Concentration for TAK-272F|Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng/mL||Standard Deviation|Geometric Mean
1317320|NCT02367872|Primary|AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-272F|AUClast,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to time of last quantifiable post-dose of TAK-272.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317321|NCT02367872|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
1317322|NCT02367872|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1317335|NCT02367521|Secondary|Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score|Trailmaking A is a psychological test with a score that is the number of seconds spent in connecting 25 numbered circles in sequential order. Score ranges from 0-150. Higher score reflects poorer outcome.|Mean at baseline and 16 weeks||||seconds||Standard Deviation|Mean
1317323|NCT02367872|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Form of TAK-272 (TAK-272F) and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1317324|NCT02367521|Secondary|Presence of Social Connections as Assessed by the Social Ties Checklist (STC)|The STC reflects the level of social contact. The score ranges from 0-10, with 0= excellent contact, 10=no contact. A higher score reflects poorer social contact.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317325|NCT02367521|Secondary|Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire|The SWL is a 7-point Likert-style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317326|NCT02367521|Secondary|Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)|MOAS measures four types of aggressive behavior as witnessed in the past week. Each section consists of five items, with the first section regarding verbal aggression, the second section focusing on aggression against property, the third section measuring autoaggression, and the fourth section concerning physical aggression. Participants are asked to check each item that is true over the last week. Items are allocated 0, 1, 2, 3 or 4 point(s), and then all points for each selected item are summed. The maximum total for each section is 10 if all items are selected. Total score ranges from 0-40 with a higher score indicating more aggressive behavior.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317327|NCT02367521|Secondary|Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)|The FSS is a 9-item questionnaire which measures the severity of fatigue and how it interferes with certain activities. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The score ranges from 9 to a maximum of 63. A higher score reflects greater fatigue severity.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317328|NCT02367521|Secondary|Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)|Participants are asked to rate the severity of 16 different symptoms over the past 24 hours, on a severity scale from 0 to 4 (0 = not experienced, 1 = no more of a problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem). The 16 symptoms include: headaches, dizziness, nausea and/or vomiting, hyperacusis, sleep disturbance, fatigue, being irritable, feeling depressed, feeling frustrated, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision, restlessness. Score ranges from 0 to 64, with a higher score reflecting increased severity of post-concussive symptoms.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317329|NCT02367521|Secondary|Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)|The NBRS is a 28-item interview which includes a test of orientation and memory for recent events, questions regarding emotional state, post-concussional symptoms, focused attention, and concentration (performing serial sevens), explanation of proverbs, tasks of planning and mental flexibility, and delayed recall of three objects presented at the beginning of a session. Observations are also made regarding the patient's fatigability, visible signs of anxiety, disinhibition, agitation, hostility, difficulties in expressive and receptive communication, and disturbance of mood. The balance of the items are rated according to the patient's performance on brief tasks and quality of answers to interview questions. Each of the 28 items are scored on a scale of 0 (not severe) to 6 (extremely severe), for a maximum score of 168. A higher score reflects increased severity of neuropsychiatric symptoms.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317330|NCT02367521|Secondary|Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)|"MOCA is designed to assess cognitive impairment and Alzheimer's Disease. It is composed of the following:~Visuospatial and Executive Functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed Recall (Short-term Memory): 5 points Orientation: 6 points Education Level: 1 point is added to the test-taker's score if he or she has 12 years or less of formal education.~Score ranges 0-31, with ≥ 26 being normal cognitive function. The lower the score, the greater the level of cognitive impairment."|Mean at baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
1317331|NCT02367521|Secondary|Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)|The ESS is used to determine the level of daytime sleepiness. It is a questionnaire composed of 8 questions. The participant answers each question on a scale of 0 to 3 (0=no sleepiness, 1= mild sleepiness, 2= moderate sleepiness, 3= severe sleepiness). The total score is the sum of all responses for a maximum score of 24. A higher score reflects increased sleepiness.|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317332|NCT02367521|Secondary|Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)|The PSQI score scale ranges from 0-21. 0 = very good sleep quality 21 = very bad sleep quality A total score of “5” or greater is indicative of poor sleep quality (reflecting a higher level of fatigue)|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317333|NCT02367521|Secondary|Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)|"The DTS is a 17-item self-reported measure that assesses the 17 Diagnostic and Statistical Manual IV (DSM-IV) symptoms of post-traumatic stress disorder (PTSD).~Items are rated on 5-point frequency (0 = not at all to 4 = every day) and severity scales (0 = not at all distressing to 4 = extremely distressing).~The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The severity score will be used to assess this outcome."|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317334|NCT02367521|Secondary|Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire|"The GAD-7 questionnaire is used as a screening tool and severity measure for generalized anxiety disorder. The scale ranges from 0 - 21.~0-4 = normal 5-9 = mild 10-14 = moderate >15 = severe"|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317336|NCT02367521|Secondary|Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)|BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location. Scoring of the immediate recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial, for a total score ranging from 0-36, with a higher score reflecting a better outcome.|Mean at baseline and 16 weeks||||accurately-drawn figures||Standard Deviation|Mean
1317337|NCT02367521|Secondary|Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)|BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location after a 25-minute delay filled with other distractor tasks. Scoring of the delayed recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial for a total score range of 0-36, with higher scores indicating a better outcome.|Mean at baseline and 16 weeks||||accurately-drawn figures||Standard Deviation|Mean
1317338|NCT02367521|Secondary|Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)|The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. After the third learning trial, the patient is read 24 words and is asked to say “yes” after each word that appeared on the recall list (12 targets) and “no” after each word that did not (12 distractors). Half of the distractors are drawn from the same semantic categories as the targets (related distractors) and half are drawn from other categories (unrelated distractors). The number of correctly-recalled words in each trial is recorded (maximum of 12 per trial). The score is the sum of all the correctly-recalled words from each trial, for a maximum of 36. T-scores are reported (average T-score of 50 (ranges 40-60)|Mean at baseline and 16 weeks||||T-score of correctly-recalled words||Standard Deviation|Mean
1317339|NCT02367521|Secondary|Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)|The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. The number of correctly-recalled words in each trial is recorded (maximum of 12). The score is a sum of all the correctly-recalled words from each trial, for a maximum score of 36.|Mean at baseline and 16 weeks||||sum of correctly-recalled words||Standard Deviation|Mean
1317340|NCT02367521|Secondary|Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score|The Trailmaking B score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. A maximum of 300 seconds is allowed. Score ranges from 0-300. Higher score reflects poorer outcome.|Mean at baseline and 16 weeks||||seconds||Standard Deviation|Mean
1317341|NCT02367521|Secondary|Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)|The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of correct trials, ranging from 0-128. A higher score reflects a better outcome.|Mean at baseline and 16 weeks||||correct trials||Standard Deviation|Mean
1317342|NCT02367521|Secondary|Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)|The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of errors, ranging from 0-128. A higher score reflects a poorer outcome.|Mean at baseline and 16 weeks||||errors||Standard Deviation|Mean
1317343|NCT02367521|Secondary|Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)|The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of completed categories, ranging from 0-6. A higher score reflects a better outcome.|Mean at baseline and 16 weeks||||completed categories||Standard Deviation|Mean
1317344|NCT02367521|Secondary|Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)|"The SCWT is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants are required to read three different tables as fast as possible. Two of the tables represent the congruous condition in which participants are required to read names of colors printed in black ink and name different color patches. In the third table, incongruous condition the color-words are printed in a different color in (ie: the word red is printed in green ink). Within this third table, participants are required to name the color of the ink instead of reading the word. The score is based on the number of items completed, which ranges from 0 to 100, with a higher score reflecting a better outcome."|Mean at baseline and 16 weeks||||items completed||Standard Deviation|Mean
1317345|NCT02367521|Primary|Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)|The BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317366|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
1317346|NCT02367521|Primary|Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)|"The CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S is only performed at baseline.~The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317347|NCT02367521|Primary|Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale|The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, >/= 23 = Very Severe Depression.|Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks||||units on a scale||Standard Deviation|Mean
1317348|NCT02367391|Secondary|Total Score on the Positive Smoking Cessation Activities Measure|Total score for 6 items (scored 0-3). Total score range 0-18.|12 weeks|This data is presented for only participants who showed to Visit 2.|||activities||Standard Deviation|Mean
1317349|NCT02367391|Secondary|Time (in Days) to Relapse After the Target Quit Day||12 weeks||||days||Standard Deviation|Mean
1317350|NCT02367391|Secondary|Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.||12 weeks||||Participants|||Count of Participants
1317351|NCT02367391|Primary|Number of Active Smoking Cessation Activities Used|Number of activities completed out of 6|12 weeks|This data is presented for only participants who showed to Visit 2.|||activities||Standard Deviation|Mean
1317352|NCT02367391|Primary|Number of Days of Varenicline Use||12 weeks||||days||Standard Deviation|Mean
1317353|NCT02367391|Primary|Sustained Abstinence at the 12-week Follow up||12 weeks||||Participants|||Count of Participants
1317354|NCT02367391|Primary|Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)||12 weeks||||Participants|||Count of Participants
1317355|NCT02367170|Secondary|A Change in the Urinary Excretion Markers of Muscle Catabolism From Baseline|Investigators will determine the effects of IMST on urinary excretion markers of muscle catabolism in patients with CCI. Investigators hypothesize that exercise will decrease urinary markers of catabolism compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21|||||||
1317356|NCT02367170|Secondary|A Change in the Results of the Biomarkers of Inflammation From Baseline|Investigators will determine the effects of IMST on biomarkers of inflammation in patients with CCI. Investigators hypothesize that exercise will decrease markers of inflammation compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21|||||||
1317357|NCT02367170|Primary|A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients|In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will lead to improvements in all three measures. This study will provide information about possible effective respiratory muscle rehabilitation techniques that are likely to lead to reduced time patients will require mechanical ventilation and improved MIP and weaning outcome in long-term, failure to wean patients|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28|Unable to recruit sufficient number of patients.||||||
1317358|NCT02367131|Secondary|Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period|Change from baseline in Fasting plasma glucose at the last observation during the observation period.|Baseline and last observation on treatment, up to week 52|Efficacy set|||mg/dL||Standard Deviation|Mean
1317359|NCT02367131|Secondary|Change From Baseline in HbA1c at the Last Observation During the Observation Period|Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period|Baseline and last observation on treatment, up to week 52|Efficacy Set: This analysis set is a subset of the safety set, which included all patients in the “safety set” except those who had no available efficacy data.|||Percentage||Standard Deviation|Mean
1317360|NCT02367131|Primary|Percentage of Patients With Adverse Drug Reactions (ADRs)|Percentage of patients with drug related Adverse events|From first drug administration until 7 days after last drug adminstration, up to 52 weeks|Safety set|||Percentage of participants|||Number
1317361|NCT02367066|Secondary|Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||L/h||Standard Deviation|Mean
1317362|NCT02367066|Secondary|Plasma AZD1981 AUC(0-24h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317363|NCT02367066|Secondary|Plasma AZD1981 AUC(0-12h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317364|NCT02367066|Secondary|Plasma AZD1981 AUC(0-4h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317365|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mmol/L||Standard Deviation|Geometric Mean
1317367|NCT02367066|Secondary|Plasma Paracetamol AUC(0-t)||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||h*ng/ML||Geometric Coefficient of Variation|Geometric Mean
1317368|NCT02367066|Secondary|Time of Maximum Plasma Paracetamol Concentration, t_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||h||Full Range|Median
1317369|NCT02367066|Secondary|Plasma Paracetamol Maximum Concentration, C_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1317370|NCT02367066|Secondary|Plasma AZD1981 AUC(1-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317371|NCT02367066|Secondary|Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317372|NCT02367066|Secondary|Plasma AZD1981 AUC(0-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317373|NCT02367066|Secondary|Plasma AZD1981 AUC(0-1h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317374|NCT02367066|Secondary|Time of Maximum Plasma AZD1081 Concentration, t_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h||Full Range|Median
1317375|NCT02367066|Secondary|Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1317376|NCT02367066|Secondary|Fasting Insulin at Endpoint||Day 3 and Day 9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||UIU/ML||Standard Error|Least Squares Mean
1317377|NCT02367066|Secondary|Change From Baseline to Endpoint Fasting Beta-cell Responsiveness||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||10^-9*(L/kg)*min||Standard Error|Least Squares Mean
1317378|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mmol/L||Standard Deviation|Geometric Mean
1317379|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mmol/L||Standard Deviation|Geometric Mean
1317380|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mU/L||Standard Deviation|Geometric Mean
1317381|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mU/L||Standard Deviation|Geometric Mean
1317382|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
1317383|NCT02367066|Secondary|Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
1317709|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 7|Percentage of adults and babies with scaling on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317384|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mU/L||Standard Deviation|Geometric Mean
1317385|NCT02367066|Primary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide|GGI=Glucose and GLP1 infusion AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
1317386|NCT02367066|Primary|Change From Baseline to Endpoint MMTT C_max for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||nmol/L||Standard Deviation|Geometric Mean
1317387|NCT02367066|Primary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose|MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*nmol/L||Standard Deviation|Geometric Mean
1317388|NCT02366936|Primary|Number of Infants That Developed Dolichocephaly by the End of the Study|dolichocephaly for this study is considered a cranial Index <76% at 34 weeks post menstrual age (PMA)|34 weeks gestational age||||participants|||Number
1317389|NCT02366936|Primary|Cranial Index (CI)|"CI was determined by calculating the ratio of the biparietal diameter (BiPD) over the occipitofrontal diameter (OFD). The BiPD is defined as the widest transverse diameter of the head. BiPD was measured from the most prominent lateral point on each side of the skull in the area of parietal and temporal bones. The OFD is defined as the diameter of the head from the most prominent midline point of the frontal bone (glabella) to the occipital protuberance. While various reported ranges exist for cranial molding norms, dolichocephaly was defined as a CI of <76%. The normative CI range is 76-85% for prone and supine sleeping infants.~CI = BPD/OFD x 100"|34 weeks gestational age||||cranial index||Full Range|Median
1317390|NCT02366923|Primary|Moisture Retention (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Full Range|Median
1317391|NCT02366923|Primary|Moisture Retention (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Standard Deviation|Mean
1317392|NCT02366923|Primary|Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Full Range|Median
1317393|NCT02366923|Secondary|Subjective Comfort of Stenfilcon A and Delefilcon A|Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)|Up to 12 Hours of Wear||||units on a scale||Standard Deviation|Mean
1317394|NCT02366923|Primary|Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Standard Deviation|Mean
1317395|NCT02366910|Primary|Moisture Retention (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Full Range|Median
1317396|NCT02366910|Primary|Moisture Retention (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Standard Deviation|Mean
1317397|NCT02366910|Primary|Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Full Range|Median
1317398|NCT02366910|Primary|Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Standard Deviation|Mean
1317399|NCT02366767|Secondary|Efficacy of Hybrid Closed-loop System in Comparison With Control|As measured by overall mean sensor glucose percent time in range 70-180 mg/dL.|6 days|Including only sensor data where the daily median ARD <15%.|||Percent time||Standard Error|Mean
1317400|NCT02366767|Secondary|Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the system initiating and operating properly for at least 75% of the time for 75% of subjects.~As measure by the completion of study enrollment procedures and education on system use within 2 hours for 75% of the subjects."|6 days||||participants|||Number
1317401|NCT02366767|Primary|Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects~As measured by the number of events of system alerts of plasma glucose values >300 mg/dL lasting for more than one hour in all subjects.~As measured by number of events of serum ketones >3 mmol/L in all subjects~As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects"|6 days|10 subjects who completed study|||Events|||Number
1317402|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months||||units on a scale||Standard Deviation|Mean
1317403|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months||||units on a scale||Standard Deviation|Mean
1317404|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
1317405|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months||||units on a scale||Standard Deviation|Mean
1317406|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months||||units on a scale||Standard Deviation|Mean
1317407|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
1317408|NCT02366663|Secondary|Cumulative Incidence of New, Abnormal Cytogenetics|The cumulative incidence of therapy related new, abnormal cytogenetics will be estimated for both groups taking into account the competing risk of death among patients who do not develop a second malignancy.|Day 0 to Year 5 post-HCT|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
1317409|NCT02366663|Secondary|Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0|Observed toxicities will be summarized in terms of type and severity. In accordance with the secondary study objectives, descriptive analyses on these data will be performed.|Day -21 to Day +100 post-HCT|Number of patients with grade 3, 4 or 5 toxicities in each arm, are reported below.|||Participants|||Count of Participants
1317410|NCT02366663|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be compared between treatment arms using a log-rank test, and the cumulative incidence curves will be estimated.|Day 0 to Day 100 post-HCT|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the descriptive analysis was performed. The median time to platelet engraftment and range are reported below.|||days||Full Range|Median
1317411|NCT02366663|Secondary|Cumulative Incidence of Secondary Malignancies|Incidence of myelodysplastic syndrome (MDS), and secondary acute Myelogenous leukemia (AML) will be compared between the treatment arms using Gray’s test.|Up to 5 years|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
1317412|NCT02366663|Secondary|Incidence of Non-relapse Mortality (NRM) Defined as Death Occurring in a Patient From Causes Other Than Relapse or Progression|The cumulative incidence of NRM will be estimated using the method described by Gooley et al. Differences between cumulative incidence curves in the presence of a competing risk will be tested using the Gray method.|From randomization until non-disease related death, or last follow-up, whichever comes first, assessed up to 5 years|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
1317413|NCT02366663|Secondary|Incidence of Infection|Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any. The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient. The proportion of patients developing infections will be compared between treatment arms.|Day 0 to Day +100 post-HCT|The study was terminated before the data are mature enough to conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
1317523|NCT02361736|Primary|Concentration of NGAL in Urine on 5 Time Point|Neutrophil gelatinase–associated lipocalin (NGAL) is a small protein, which is filtered via the glomeruli and reabsorbed in the proximal tubules, and thus low concentrations of NGAL can be measured in the blood and urine.|-1d, 0d, 1d, 3d, 5d after surgery||||ng/ml||Standard Deviation|Mean
1317414|NCT02366663|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be compared between treatment arms using a log-rank test, and the cumulative incidence curves will be estimated.|Day 0 to Day 100 post-HCT|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the descriptive analysis was performed. The median time to ANC engraftment and range are reported below.|||days||Full Range|Median
1317415|NCT02366663|Secondary|Number of Patients With Complete or Partial Response at Day 30|Definition of disease status is based on the article of Revised Response Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al, 2007). Tests used for evaluation of disease status would be physical examination, laboratory testing, bone marrow testing, bone marrow biopsy and aspirate, PET scan, and CT scans of neck, chest, abdomen and pelvis as indicated.|Day 0 to Day +30 post-HCT|In Arm I (ZBEAM), one patient's disease status at Day 30 is not available. Therefore, the overall number of participants analyzed in Arm I (ZBEAM) is 1.|||Participants|||Count of Participants
1317416|NCT02366663|Secondary|Time to Progression|Time-to-event will be measured from the date of ASCT.|Up to 5 years|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
1317417|NCT02366663|Secondary|Progression-free Survival|Survival estimates will be calculated using the Kaplan-Meier method|Measured from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up whichever comes first, for up to 5 years post randomization|The study was terminated before the data are mature enough to estimate the survival outcome and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
1317418|NCT02366663|Primary|Overall Survival|Survival estimates will be calculated using the Kaplan-Meier method|Measured from randomization to date of death or last follow up date, whichever occurs first, for up to 5 years post randomization|The study was terminated before the data are mature enough to estimate the survival outcome and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
1317419|NCT02366637|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct and indirect bilirubin, gamma-glutamyl transpeptidase [GGT], alkaline phosphatase, uric acid, albumin, total protein, high sensitivity C-reactive protein [CRP]); urinalysis (specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [only if urine dipstick was positive for blood or protein]).|Baseline up to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1317420|NCT02366637|Other Pre-specified|Change From Baseline in Pulse Rate|Pulse rate was evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||beats per minute (bpm)||Standard Deviation|Mean
1317421|NCT02366637|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure|Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1317422|NCT02366637|Other Pre-specified|Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to 200 msec; QRS interval >=200 msec or >=25/50% increase from baseline; QT interval >=500 msec; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1317423|NCT02366637|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1317424|NCT02366637|Secondary|Trough Plasma Concentration (Ctrough) of PF-03715455|Ctrough is the concentration prior to study drug administration.|Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As PK was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.||||||
1317425|NCT02366637|Secondary|Maximum Observed Plasma Concentrations (Cmax) of PF-03715455||Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As pharmacokinetics (PK) was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.||||||
1317426|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.|Baseline, Week 1 to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
1317427|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
1317428|NCT02366637|Secondary|Change From Baseline in Sputum Cell Counts Over 4 Weeks|Sputum cell counts included total neutrophils counts and differential (percent [%]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.|Baseline, Week 1 to Week 4|It was not meaningful to summarize sputum cell counts as there were too few participants in the sputum sub-study and, of those, too few adequate sputum specimens to be meaningfully summarized.||||||
1317429|NCT02366637|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Baseline (Day 1), Day 29 (Week 4)|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
1317430|NCT02366338|Primary|Number of Patients With at Least One Inappropriate MAI Criterion|Appropriateness of oral anticoagulants was evaluated by adapted versions of the MAI|1 day||||participants|||Number
1317431|NCT02366195|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 grading scale, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE Treatment-related adverse events (TRAE) were those assessed by the investigator as possibly related to talimogene laherparepvec.|From first dose through 30 days after last dose of talimogene laherparepvec; median duration of treatment was 25 (range 0.1 - 84) weeks.|Participants who received at least 1 dose of talimogene laherparepvec.|||Participants|||Count of Participants
1317432|NCT02366195|Secondary|Change From Baseline in Tumor Burden|"Tumor burden is the sum of the products of the 2 largest perpendicular diameters (SPD) for all index lesions selected at baseline.~Change from baseline in tumor burden was assessed in participants with an objective response."|Baseline and cycle 6 day 1, cycle 12 day 1, cycle 18 day 1, and cycle 24 day 1. The first cycles was 21 days and all subsequent cycles were 14 days.|Participants who received at least 1 dose of talimogene laherparepvec with an objective response (CR or PR).|||mm²||Standard Deviation|Mean
1317433|NCT02366195|Secondary|Overall Survival|"Overall survival (OS) was defined as the time from the date of first dose to the date of death from any cause.~OS time was censored at the last date the participant was known to be alive when the confirmation of death is absent or unknown."|From first dose of study drug until the data cut-off date of 26 June 2017; median time on follow-up was 59 weeks (range 2.7 to 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
1317434|NCT02366195|Secondary|Durable Response Rate|Durable response rate (DRR) was defined as the percentage of participants with an objective response (CR or PR) based on modified WHO response criteria lasting continuously for 6 months and starting any time within 12 months of initiating therapy.|24 months following last subject enrolled|Participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
1317435|NCT02366195|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was calculated from first dosing until one or more of the following: (1) clinically relevant disease progression (PDr); (2) death from any cause; (3) non clinically relevant disease progression (PDn) associated with a requirement for alternative therapy as the reason for ending treatment or start of new anti-cancer therapy. Participants with no event were censored at their last evaluable tumor assessment.|24 months following last subject enrolled|Participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
1317436|NCT02366195|Secondary|Duration of Response|"Duration of response (DOR) was defined as the longest individual period from entering an objective response (CR/PR) to the first documented evidence of the participant no longer meeting the criteria for objective response (i.e. an overall response of either stable disease [SD] as compared with baseline or progressive disease [PD]).~SD: Neither sufficient tumor shrinkage of index lesion to qualify for response (PR or CR) nor sufficient tumor increase of index lesion to qualify for PD, with no increase in size of non-index lesions.~PD: A > 25% increase in the sum of the SPD of all index tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point, or unequivocal progression of one or more non-index lesions.~Participants last reported to be either a CR or PR were censored at that time point."|Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up at the time of the data cut-off date (26 June 2017) was 59 weeks (range 2.7 to 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with an objective response.|||months||95% Confidence Interval|Median
1317437|NCT02366195|Secondary|Objective Response Rate|"Objective Response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) based on Modified WHO Response Criteria.~CR: Complete disappearance of all index lesions, all non-index lesions, and any new tumors which might have appeared. Any residual cutaneous or subcutaneous index lesions must be documented by representative biopsy to not contain viable tumor.~PR: Disappearance of all index lesions with persistence of one or more non-index tumor(s), or, 50% or greater reduction in the SPD of all index lesions as compared to baseline, and disappearance or persistence of non-index lesions."|Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up at the time of the data cut-off date (26 June 2017) was 59 weeks (range 2.7 to 116 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
1317524|NCT02361580|Secondary|Symptoms of Depression Measured by PROMIS Depression|Symptoms of depression measured by PROMIS Depression|8 weeks|All of the subjects were lost to follow up.||||||
1317438|NCT02366195|Secondary|Correlation Between Change From Baseline in Intratumoral CD8+ Cell Density and Changes in Tumor Burden|"Pearson’s correlation coefficient (r) was estimated to assess the relationship between change from baseline in log2(CD8+ cell density) in uninjected lesions and the maximum decrease in measurable tumor burden.~Tumor burden is the sum of the products of the 2 largest perpendicular diameters (SPD) for all index lesions selected at baseline.~The Pearson’s correlation coefficient (r) of log2(change from baseline intratumoral CD8+ cell density) and the maximum decrease in tumor burden is reported."|Intratumoral CD8+ cell density was assessed at baseline and week 6. Tumor burden was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 (range 2.7 - 116) weeks.|Participants who received at least 1 dose of talimogene laherparepvec with available tumor burden data and baseline and week 6 CD8+ cell density data for uninjected lesions.|||Pearson’s correlation coefficient||95% Confidence Interval|Number
1317439|NCT02366195|Secondary|Correlation Between Change From Baseline in Intratumoral CD8+ Cell Density and Duration of Response|"A Cox proportional hazards regression model was performed to evaluate change from baseline in log2(CD8+ cell density) as a predictor of duration of response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Duration of response (DOR) is defined as the longest individual period from entering an objective response (CR/PR) to the first documented evidence of the participant no longer meeting the criteria for being in the response (i.e. an overall response of either stable disease [SD] as compared with baseline or progressive disease [PD]).~The unadjusted hazard ratio of log2(change from baseline intratumoral CD8+ cell density) for duration of response is reported."|Intratumoral CD8+ cell density was assessed at Baseline and week 6. Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 2.7 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with an objective response and with baseline and week 6 CD8+ cell density data for uninjected lesions.|||ratio||95% Confidence Interval|Number
1317440|NCT02366195|Secondary|Correlation Between Change From Baseline in Intratumoral CD8+ Cell Density and Durable Response Rate|"A univariate logistic regression model was performed to evaluate change from baseline to week 6 in log2(CD8+ cell density) in uninjected lesions as a predictor of durable response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Durable response rate (DRR) was defined as the percentage of participants with an objective response lasting continuously for 6 months and starting any time within 12 months of initiating therapy.~The unadjusted odds ratio of log2(change from baseline in intratumoral CD8+ cell density) for durable response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline and week 6. Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 2.7 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline and week 6 CD8+ cell density data in uninjected lesions.|||ratio||95% Confidence Interval|Number
1317441|NCT02366195|Secondary|Correlation Between Change From Baseline Intratumoral CD8+ Cell Density and Objective Response Rate|"A univariate logistic regression model was performed to evaluate change from baseline to week 6 in log2(CD8+ cell density) in uninjected tumors as a predictor of objective response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Objective response rate (ORR) was defined as the percentage of participants with a complete response or partial response according to the modified WHO criteria.~The unadjusted odds ratio of log2(change from baseline intratumoral CD8+ cell density) for objective response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline and week 6. Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 2.7 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline and week 6 CD8+ cell density data for uninjected lesions.|||ratio||95% Confidence Interval|Number
1317442|NCT02366195|Secondary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Changes in Tumor Burden|"Pearson’s correlation coefficient (r) was estimated to assess the relationship between baseline log2(CD8+ cell density) and the maximum decrease in measurable tumor burden.~Tumor burden is the sum of the products of the 2 largest perpendicular diameters (SPD) for all index lesions selected at baseline.~The Pearson’s correlation coefficient (r) of log2(baseline intratumoral CD8+ cell density) and the maximum decrease in tumor burden is reported."|Intratumoral CD8+ cell density was assessed at baseline. Disease burden was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 (range 2.7 - 116) weeks.|Participants who received at least 1 dose of talimogene laherparepvec with available tumor burden data and baseline CD8+ cell density data.|||Pearson’s correlation coefficient||95% Confidence Interval|Number
1317443|NCT02366195|Secondary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Duration of Response|"A Cox proportional hazards regression model was performed to evaluate baseline log2(CD8+ cell density) as a predictor of duration of response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Duration of response (DOR) is defined as the longest individual period from entering an objective response (CR/PR) to the first documented evidence of the participant no longer meeting the criteria for being in the response (i.e. an overall response of either stable disease [SD] as compared with baseline or progressive disease [PD]).~The unadjusted hazard ratio of log2(baseline intratumoral CD8+ cell density) for duration of response is reported."|Intratumoral CD8+ cell density was assessed at Baseline. Response was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 2.7 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with an objective response and with baseline CD8+ cell density data.|||ratio||95% Confidence Interval|Number
1317469|NCT02364778|Primary|MLD SB Diameter|Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)|day 1||||mm||Standard Error|Mean
1317525|NCT02361580|Secondary|Avoidance of Painful Activities Measured by PROMIS Pain Interference|Avoidance of painful activities measured by PROMIS Pain Interference|8 weeks|All of the subjects were lost to follow up.||||||
1317444|NCT02366195|Secondary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Durable Response Rate|"A univariate logistic regression model was performed to evaluate baseline log2(CD8+ cell density) as a predictor of durable response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Durable response rate (DRR) was defined as the percentage of participants with an objective response lasting continuously for 6 months and starting any time within 12 months of initiating therapy.~The unadjusted odds ratio of log2(baseline intratumoral CD8+ cell density) for durable response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline. Response was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 2.7 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline CD8+ cell density data.|||ratio||95% Confidence Interval|Number
1317445|NCT02366195|Primary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Objective Response Rate|"A univariate logistic regression model was performed to evaluate baseline log2(CD8+ cell density) as a predictor of objective response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Objective response rate (ORR) was defined as the percentage of participants with a complete response or partial response according to the modified WHO criteria.~The unadjusted odds ratio of log2(baseline intratumoral CD8+ cell density) for objective response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline. Response was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 2.7 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline CD8+ cell density data.|||ratio||95% Confidence Interval|Number
1317446|NCT02365714|Secondary|Ipsilateral Breast Recurrence|No patients have recurred to date.|1 month post radiation treatment through 5 years post treatment||||Participants|||Count of Participants
1317447|NCT02365714|Primary|Feasibility|How many patients were able to undergo CK SAPBI|2 years||||Participants|||Count of Participants
1317448|NCT02365714|Primary|The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment|Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment|Enrollment to 24 months||||Participants|||Count of Participants
1317449|NCT02365688|Primary|Dynamic Hemodynamic Response to Fluid Resuscitation|Physiological parameters compared before and after fluid bolus for fluid resuscitation.|Up to 6 hours but not to exceed duration of surgical procedure|Reference devices were in disagreement so the algorithm could not be verified||||||
1317450|NCT02365519|Secondary|Percentage of Subjects With Anti-LME636 Antibodies by Visit|Samples were collected and assessed for anti-LME636 antibodies.|Day 15, Day 29, Day 43, Day 57, Day 71, Day 85|This analysis population includes all subjects with available immunogenicity data (Immunogenicity Analysis Set).|||percentage of subjects|||Number
1317451|NCT02365519|Secondary|Percentage of Subjects With LME636 Serum Concentrations Below the Lower Limit of Quantification (LLOQ)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. LLOQ is defined as 0.25 ng/mL.|Day 15, Day 29, Day 43, Day 57, Day 71, Day 85|This analysis population includes all subjects with available pharmacokinetics data (Pharmacokinetics Analysis Set).|||percentage of subjects|||Number
1317452|NCT02365519|Secondary|Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71|Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a VAS displayed on a handheld ePRO. Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline.|Baseline (Day 43), Day 71|Per-Protocol Set|||percentage of subjects|||Number
1317453|NCT02365519|Primary|Percentage of Subjects With Increase in Dilated Fundus Parameter From Baseline to Any Visit|The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|Safety Analysis Set|||percentage of subjects|||Number
1317454|NCT02365519|Primary|Percentage of Subjects With Increase in Slit-Lamp Parameter From Baseline to Any Visit|Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|Safety Analysis Set|||percentage of subjects|||Number
1317455|NCT02365519|Primary|Intraocular Pressure (IOP)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.|||mmHg||Standard Deviation|Mean
1317456|NCT02365519|Primary|Best Corrected Visual Acuity (BCVA)|Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|This analysis population includes all subjects that received any study drug (Safety Analysis Set). Number Analyzed is the number of subjects with data at visit.|||letters||Standard Deviation|Mean
1317486|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time 24 Hours (AUC0–24) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hr*ng/mL||Standard Deviation|Mean
1317457|NCT02365519|Primary|Mean Change From Baseline in Global Ocular Discomfort Score at Day 71|Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.|Baseline (Day 43), Day 71|This analysis population includes all randomized subjects with at least a post-baseline primary endpoint assessment excluding all subjects who met the critical deviation criteria (Per-Protocol Set). Number Analyzed is the number of subjects with data at visit.|||units on a scale||Standard Error|Mean
1317458|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|12 wks after baseline|All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.|||(pg/ml)||Standard Deviation|Mean
1317459|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|6 wks after baseline|All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.|||(pg/ml)||Standard Deviation|Mean
1317460|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.|2 wks after baseline|Subjects that completed all study visits without a major protocol deviation. All 24 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.|||(pg/ml)||Standard Deviation|Mean
1317461|NCT02365298|Primary|Total Protein and Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|12 wks after baseline|All subjects that completed all study visits without a major protocol deviation.During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|||(ug/lens)||Standard Deviation|Mean
1317462|NCT02365298|Primary|Total Protein and Total Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|6 wks after baseline|Subjects that completed all study visits without a major protocol deviation. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|||(ug/lens)||Standard Deviation|Mean
1317463|NCT02365298|Primary|Total Protein and Total Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|2 wks after baseline|All subjects that completed all study visits without a major protocol deviation.|||(ug/lens)||Standard Deviation|Mean
1317464|NCT02365233|Primary|Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit|Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.|Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.|IRB withheld the data due to inadequate supporting documentation||||||
1317465|NCT02364999|Primary|Objective Response Rate (ORR) by Week 19|ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.|25 weeks|The Intent-to-Treat (ITT) population was used for analysis of ORR, and it included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
1317466|NCT02364778|Secondary|Diameter Stenosis (DS)|Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS).|day 1||||percentage of 100||Standard Error|Mean
1317467|NCT02364778|Secondary|SB Ostial Involvement|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD)|day 1||||mm||Standard Error|Mean
1317468|NCT02364778|Secondary|SB Angle|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA)|day 1||||degree||Standard Error|Mean
1317526|NCT02361580|Primary|Upper Extremity Disability Measured by PROMIS Upper Extremity|Upper Extremity Disability measured by PROMIS Upper Extremity|8 weeks|All of the subjects were lost to follow up in both groups.||||||
1317470|NCT02364700|Secondary|Stroke Impact Scale --Hand Sub Scale (SIS-H)|"The Stroke Impact Scale is a stroke-specific questionnaire evaluating quality of life in stroke survivors over eight domains. Each domain is scored independently on an ordinal scale ranging from 0 (minimum) bto a maximum of 5. Only the Hand sub-score was used in this study. Scores for each domain are transformed and range from 0-100.~Formula for scoring domains:~Transformed Scale = [(Actual raw score - lowest possible raw score) / Possible raw score] * 100"|baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
1317471|NCT02364700|Secondary|Hand Dynamometry|A dynamometer measures grip strength in kilograms|baseline to 6 weeks (discharge)||||kilograms||Standard Deviation|Mean
1317472|NCT02364700|Secondary|Stroke Upper Limb Capacity Scale (SULCS)|The SULCs is a performance based measure of upper limb capacity after stroke. Each of the 10 items are administered in a hierarchical order and assigned a score of 0 (unable to complete) or 1 (able to complete the task) with a maximum score of 10.|Baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
1317473|NCT02364700|Primary|Box and Blocks|The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.|Baseline to 6 weeks (discharge)||||totally number of blocks transferred||Standard Deviation|Mean
1317474|NCT02364700|Primary|Arm Motor Ability Test (AMAT)|The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.|Baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
1317475|NCT02364700|Primary|Fugl-Meyer Assessment of Upper Extremity (FMA)|The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.|baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
1317476|NCT02364180|Primary|Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response|Normally when a nerve is rapidly stimulated the successive Compound Muscle Action Potentials (CMAP) are of the same height. We are hoping to investigate if chronic pyridostigmine therapy reduces the margin of safety and hence the successive CMAPs may be smaller than the preceding ones.|Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.||||percent change||Full Range|Median
1317477|NCT02363946|Secondary|Mean Percentage Change in Circulating Blood Levels of Complement Factors 2 Hours Post-Dose||Pre-dose, 2 hours post-dose|Participants with available data for given parameter.|||percentage change||Standard Deviation|Mean
1317478|NCT02363946|Secondary|Mean Percentage Change in Circulating Blood Levels of Cytokines 2 Hours Post-Dose||Pre-dose, 2 hours post-dose|Participants with available data for given parameter.|||percentage change||Standard Deviation|Mean
1317479|NCT02363946|Secondary|Number of Participants With a Return From Nadir AAT Blood Levels to Above Normal or Within 15% of Baseline in > 100 Days|Baseline AAT levels consisted of a geometric mean based on 3 assessments taken prior to study drug administration: at 2 time points during the Screening window at least 5 days apart, and on Day -1.|Baseline, up to Day 29, and through 100 days of follow-up|All participants|||participants|||Number
1317480|NCT02363946|Secondary|Maximum Percentage Reduction in Mean AAT (Nadir of Mean AAT)||Study Day for Nadir of Mean AAT: Day 8 (for Part B 2 mg/kg arm), Day 15 (for Part A 0.38 mg/kg, 2 mg/kg, 4 mg/ kg, Placebo arms; Part B 4 mg/kg, Placebo arms), Day 22 (Part A 3 mg/kg, 5 mg/kg, 6 mg/kg, 7 mg/kg arms), Day 29 (1 mg/kg, 8 mg/kg arms)|All participants who received a full dose of study drug.|||percentage reduction|||Number
1317481|NCT02363946|Secondary|Number of Participants With AAT Reduction > 30% From Baseline (First Occurrence)|Data presents the study visit day upon which a participant had the first occurrence of AAT reduction of > 30% from Baseline, and the number of participants who had a > 30% reduction at any visit (overall). Baseline AAT levels consisted of a geometric mean based on 3 assessments taken prior to study drug administration: at 2 time points during the Screening window at least 5 days apart, and on Day -1.|Baseline, Days 3, 8, 15, 22 and 29|All participants who received a full dose of study drug with evaluable data at given time point.|||participants|||Number
1317482|NCT02363946|Primary|Percentage Reduction From Baseline of AAT Up to Day 29|Clinical assay for total serum AAT level was used for Part A. A quantitative measurement of AAT was used for Part B. A negative percent reduction indicates a percentage increase. Baseline AAT levels consisted of a geometric mean based on 3 assessments taken prior to study drug administration: at 2 time points during the Screening window at least 5 days apart, and on Day -1.|Baseline, Days 3, 8, 15, 22 and 29|All participants who received a full dose of study drug with evaluable data at given time point.|||percentage reduction||Standard Deviation|Mean
1317483|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Half-Life (t1/2) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hours||Standard Deviation|Mean
1317484|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Terminal Elimination Rate Constant Obtained From the Slope of the Line (Kel) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||1/hour||Standard Deviation|Mean
1317485|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Area Under the Plasma Concentration Versus Time Curve From From Zero to Infinity (AUCinf) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hr*ng/mL||Standard Deviation|Mean
1317517|NCT02361736|Secondary|Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point|ACR is calculated by the urine trace albumin divided by the urine creatinine|-1d, 0d, 1d, 3d, 5d after surgery||||ratio||Standard Deviation|Mean
1317487|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Time to Maximum Observed Concentration (Tmax) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hour||Full Range|Median
1317488|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Maximum Observed Plasma Concentration (Cmax) for the Analytes AD00370 and ARC-Melittin-Like Peptide (MLP; Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||ng/mL||Standard Deviation|Mean
1317489|NCT02363946|Primary|Number of Participants With Clinically Significant Treatment-Emergent Abnormalities in Vital Signs, Electrocardiograms (ECGs), Pulmonary Function, Physical Findings, and Other Observations|Values collected include: vital signs (clinically concerning or symptomatic treatment emergent changes in heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, or temperature); ECGs (clinically significant changes from baseline were observed for ventricular rate, RR interval, QRS duration, QT interval or QT interval corrected for heart rate using Fridericia’s formula [QTcF]; treatment emergent clinically significant changes in ST segments, P wave or T wave morphology; cardiac telemetry monitoring); clinically significant abnormal physical examination findings; treatment emergent sensitivity to bee venom; pulmonary function (clinically significant worsening in spirometry parameters and carbon monoxide diffusing capacity of the lung for carbon monoxide [DLCO]).|Day 1 through Day 29 ± 1 day|All participants receiving at least 1 dose of study medication|||participants|||Number
1317490|NCT02363946|Primary|Number of Participants With Clinically Significant Treatment-Emergent Abnormalities in Laboratory Values|Laboratory values collected include: hematology (haemoglobin, lymphocytes, neutrophils, platelets, white cell count, monocytes); biochemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatine kinase, creatinine, gamma-glutamyltransferase, fasting glucose, troponin I); coagulation parameters (fibrinogen, international normalized ratio); and C-reactive protein.|Day 1 through Day 29 ± 1 day|All participants receiving at least 1 dose of study medication|||participants|||Number
1317491|NCT02363946|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Discontinuations Due to TEAEs|An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as defined as AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAEs are defined as is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.|From the first dose of study treatment through Day 29 ± 1 day|All participants receiving at least 1 dose of study medication|||participants|||Number
1317492|NCT02363933|Secondary|Percentage of Patients Who Experience a Adverse Event Possibly, Probably, or Definitely Attributable to Perampanel Treatment|The percentage of patients with unacceptable adverse events that are possibly, probably, or definitely related to perampanel treatment will be calculated. Unacceptable adverse events include all Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 4 or 5 toxicities that are possibly, probably, or definitely related to perampanel, as well as suicidal ideation (any grade) or suicide attempt (Grade 3-5).|24 Weeks|All patients treated with perampanel is included in the attributable adverse event rate.|||percentage of participants|||Number
1317493|NCT02363933|Primary|Percentage of Patients With ≥50% Seizure Reduction During the Maintenance Period Compared With Seizure Frequency Before Initiation of Perampanel|The primary objective of this study is to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma presenting refractory partial onset seizure activity. Efficacy will be assessed by the 50% responder rate, defined as the percentage of patients with a ≥50% seizure reduction during the maintenance period compared with the seizure frequency before initiation of perampanel. Seizure frequency during maintenance perampanel will be computed as the ratio of the total number of seizure episodes while receiving perampanel during the maintenance period and the number of days perampanel is administered|20 Weeks|Seizure frequency was not systematically gathered at screening. As the 50% responder rate requires an adequate baseline comparison, it is not possible to compute the 50% responder rate.||||||
1317494|NCT02363907|Primary|Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device|"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels <80 mg/dL"|Measured during clinic session during 7 day sensor wear period||||Percentage of matched pairs w/i %20/20||95% Confidence Interval|Number
1317495|NCT02363478|Secondary|Changes in the Severity of Esophageal Symptoms at Week 4|Severity of esophageal symptoms (dysphagia, heartburn, regurgitation and chest pain) was measured on a 100-point visual analogue scale (VAS) ranging from 0 (absent) to 100 (very severe). Even minor decrease in the VAS score for each symptom at week 4 considered as improvement.|before and after 4 weeks buspirone administration||||units on a scale||Standard Deviation|Mean
1317496|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration||||cm/sec||Standard Deviation|Mean
1317497|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration||||sec||Standard Deviation|Mean
1317498|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: i) Amplitude of Contractions at the Distal Part of the Esophagus and ii) Resting and Residual (Lower Esophageal Pressure) LES Pressure and IRP (Integrated Relaxation Pressure) at Week 4||before and after 4 weeks buspirone administration||||mmHg||Standard Deviation|Mean
1317499|NCT02363439|Primary|Number of Participants With Adverse Events|Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia|During receipt of study treatment on the trial.|Safety population|||Participants|||Count of Participants
1317500|NCT02363270|Primary|Overall Rate of Feeling Unreality|Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)|30 minutes||||Participants|||Count of Participants
1317501|NCT02362412|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.|Up to 22 weeks|Safety Analysis Set (SAF), which included participants who received at least one dose of study drug.|||Participants|||Number
1317502|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||Standard Deviation|Mean
1317503|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
1317504|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
1317505|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill)|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||Standard Deviation|Mean
1317506|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
1317507|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
1317508|NCT02362412|Secondary|Hamilton Depression Scale (HAM-D17)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
1317509|NCT02362412|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||UNITS ON A SCALE||95% Confidence Interval|Least Squares Mean
1317510|NCT02362373|Secondary|Number of Participants Continuing With IUD|Women continuing the IUD for contraception at 6 months|6 months||||participants|||Number
1317511|NCT02362373|Secondary|Change in Seizure Frequency|Number of participants with increased, unchanged or decreased mean monthly seizure frequency.|baseline to 6 months||||participants|||Number
1317512|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|3 out of 20 participants received oxcarbazepine while on IUD.|||percentage of participants|||Number
1317513|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.|from baseline to 6 months after LNG IUS insertion|5 out of 20 participants received levetiracetam while on IUD.|||percentage of participants|||Number
1317514|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|13 out of 20 participants received lamotrigine while on IUD.|||percentage of participants|||Number
1317515|NCT02362360|Primary|"Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good."|"Subjects will evaluate the fit to body for each product by answering the question How was the baseplates ability to fit to the body contours in the area around the stoma?. The question is answered with a 5-point scale ranging from very poor to very good."|21 +/- 3 days||||percentage of subjects answering|||Number
1317516|NCT02362321|Primary|Rate of Need for Surgery Drainage|The rate of success of conservative management was defined as the number of patients not requiring surgery in each treatment group during the 6 months following enrollment.|Within 6 months||||participants|||Number
1329610|NCT02107014|Primary|Change in IL-13 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1317527|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks||||units on a scale||Standard Error|Mean
1317528|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks||||units on a scale||Standard Error|Mean
1317529|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
1317530|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||units on a scale||Standard Error|Mean
1317531|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks||||units on a scale||Standard Error|Mean
1317532|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
1317533|NCT02360774|Secondary|Change in Glycemic Control|Hemoglobin A1C will be measured at baseline and at study completion.|18 weeks (duration of study)||||percent glycated hemoglobin||Standard Error|Mean
1317534|NCT02360774|Secondary|Change in Body Composition, Measured Using DXA Scanning.|Body composition will be measured at baseline and at study completion using DXA scanning.|18 weeks (duration of study)||||% fat||Standard Error|Mean
1317535|NCT02360774|Secondary|Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery|Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study.|18 weeks (duration of study)||||kcal||Standard Error|Mean
1317536|NCT02360774|Primary|Change in Body Weight|Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit.|18 weeks (duration of study)||||kg||Standard Error|Mean
1317537|NCT02360475|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to study end at Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.|||Participants|||Count of Participants
1317538|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 90 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
1317539|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 60 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
1317540|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 30 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
1317541|NCT02360475|Secondary|Concentrations of Palivizumab Competing Antibodies (PCA)|Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 0 pre-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
1317561|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration,amplitude is reported here as the average value from 20 chewing strokes in units of microvolts."|three months||||microvolts||Standard Deviation|Mean
1317542|NCT02360475|Secondary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).|At Day 90 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
1317543|NCT02360475|Secondary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).|At Day 60 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
1317544|NCT02360475|Primary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).|At Day 30 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
1317545|NCT02360475|Primary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).|At Day 0 pre-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
1317546|NCT02360475|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From vaccination at Day 0, up to Day 30 post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.|||Participants|||Count of Participants
1317547|NCT02360475|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|During the 30-Day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.|||Participants|||Count of Participants
1317548|NCT02360475|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1317549|NCT02360475|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
1317550|NCT02360228|Secondary|Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State|The investigators will compare peak frequency of functional connectivity from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze the change in peak frequency of functional connectivity as a pilot study for derivation of EEG biomarkers.|Baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed the study protocol.|||Hertz (Hz)||Standard Deviation|Mean
1317559|NCT02360059|Primary|Mean Change in Neuropathy|Change in neuropathy as assessed with the chemotherapy-induced peripheral neuropathy (CIPN) survey QLQ-CIPN20 between T1 and T5 where difference in mean area under the curve (AUC) between groups reported. The AUC for response from T1 to T5 is computed by fitting a series of trapezoids to the QLQ-CIPN20 data assessed at T1, T2, T3, T4, and T5, respectively, and summing up their areas [AUC calculated - base of a trapezoid corresponds to the number of days between assessments, and the heights correspond to two adjoining symptom responses, number of trapezoids depends on number of symptom assessments and sum of area for all trapezoids represents AUC of particular participant]. QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) using a 4-point Likert scale (1 = “not at all,” 2 = “a little,” 3 = “quite a bit,” and 4 = “very much”) with the higher score denoting more symptom burden.|Up to 14 weeks, assessed every 3 weeks ±1 week (T2, T3, T4, T5) during paclitaxel therapy|Study stopped early with only one participant, analysis not possible.||||||
1317551|NCT02360228|Other Pre-specified|Change in Electroencephalogram (EEG) Auditory Tasks: Click Train Task From Baseline|"The investigators will compare auditory responses during auditory tasks EEG recordings on the first and last day of stimulation. The investigators will also collect this data at the one week and one month follow up visits.~Auditory steady-state response (ASSR) from EEG data elicited by auditory click trains is considered as a hallmark of network dysfunction in schizophrenia. To obtain ASSR, auditory tones at a specific frequency (e.g., 40Hz) are presented for multiple trials and EEG data is analyzed to extract brain responses to the stimuli.~One common way to extract the brain responses from this task is phase coherence between trials. When external stimuli (click trains) occur, brain signals are synchronized to these stimuli and its coherence should be the highest at the stimulation frequency. Phase information for calculating the coherence can be obtained by time-frequency analysis. Averaged coherence across the multiple trials can represent the inter-trial phase coherence."|baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||inter-trial phase coherence||Standard Deviation|Mean
1317552|NCT02360228|Other Pre-specified|Change in Electroencephalogram (EEG) Auditory Tasks: Oddball Task From Baseline|"The investigators will compare auditory responses during auditory tasks EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers and look for increase in auditory responses.~Auditory oddball paradigm is an experimental design that has standard (low-pitch) and deviant (high-pitch) stimuli. Differences in ERP from these two stimuli can measure functions of sensory processing. Patients with schizophrenia often exhibit abnormal responses to the stimuli thus its discrepancy compared to healthy human participants can be a hallmark of symptoms in schizophrenia."|baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||micro volts||Standard Deviation|Mean
1317553|NCT02360228|Secondary|Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery of cognitive assessments assessing verbal memory and learning, working memory, motor function, verbal fluency, speed of processing, and executive function. Higher scores indicate better cognitive performance. The investigators will compare the BACS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures.~Verbal Memory: Score out of 75~Digit Sequencing: Score out of 28~Token Motor: Score out of 100~Fluency: No score limit~Symbol Coding: Score out of 110~Tower of London: Score out of 22~Reported score is the mean of these 6 subtests. Healthy controls (Keefe et al., 2006) scored 45.6 as a comparison."|baseline, five days post baseline, five weeks post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||scores on a scale||Standard Deviation|Mean
1317554|NCT02360228|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Scores|The investigators will compare the PANSS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures. Scores range from 30 to 210, with higher scores indicating more severe symptomology.|baseline, five days post baseline, five weeks post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||scores on a scale||Standard Deviation|Mean
1317555|NCT02360228|Secondary|Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline|The investigators will compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.|Baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed the study protocol.|||decibel (dB)||Standard Deviation|Mean
1317556|NCT02360228|Primary|Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score|The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assesses frequency, duration, location, loudness, belief of origin of voices, negative content, distress, disruption to life, and control over voices. All items are measured on a scale of 0 to 4, with a total possible score of 44. Higher scores indicate higher severity of auditory hallucinations. The investigators will compare the AHRS scores from immediately before the first stimulation and immediately after the last stimulation session as the investigator's primary outcomes measure.|Baseline, five days post baseline, 2 weeks post baseline, 5 weeks post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||proportion to baseline||Standard Deviation|Mean
1317557|NCT02360124|Secondary|Proportion of Inactive Root Caries Lesions|the proportion of active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination will be calculated. The calculation is to divide the number of caries lesions that have changed status from active to inactive (assessed in clinical examination) by the number of active caries lesions found at baseline|30 months|The participants were the active root caries lesions found at baseline in each group.|||percentage of inactive root caries|||Number
1317558|NCT02360124|Primary|Number of New Tooth Root Caries Lesions|the number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination|30 months||||new carious root surfaces||Standard Error|Mean
1317560|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration, duration here is reporteds the average value from 20 chewing strokes in units of millisecond."|three month||||millisecond||Standard Deviation|Mean
1317607|NCT02359305|Secondary|PACU Time|Time spent in the post-anesthesia care unit post-operatively.|45-60 minutes post-operatively||||minutes||Standard Deviation|Mean
1317562|NCT02359955|Secondary|Masticatory Efficiency Index|the masticatory efficiency is tested after patient wears complete denture for three months,each patient was given 4 gram dry peanuts, chewed for 20 seconds, then spat in the receptacle and rinsed mouth residue. The peanut particles were diluted to 1000 ml with distilled water, stirred for 1 minutes and standing for 2 minutes to suspension. Absorbance values(av) were measured at the wavelength of 590nm in a spectrophotometer. The higher the masticatory efficiency, the smaller the peanut particles, then the higher the av value, vice versa. Value of av was used to represent masticatory efficiency. For each patient, the test was conducted three times, and the average value of av was taken as the final result. A lower masticatory efficiency index indicates larger peanut particle size observed.|three months||||index score||Standard Deviation|Mean
1317563|NCT02359916|Secondary|Total Daily Vending Revenue in US$/Day|Total vending machine revenue under each condition|Number of days per condition were as follows - Baseline: 119 days, Discount only: 59 days, Delay only: 68 days, Delay + Discount: 49 days, Tax only: 73 days, Delay + Tax: 60 days|"The unit of analysis is vending revenue per day ($/day). Data from Baseline 1 and Baseline 2 were combined into a single arm/group (Baseline) in this analysis."|||$/day|Days|Standard Deviation|Mean
1317564|NCT02359916|Primary|Proportion of Healthy Snacks Purchased|For each experimental condition, we will calculate the proportion of healthy vs unhealthy snacks sold over 4 weeks.|28 weeks per vending location|"In this table, each vend is treated as an analyzed participant. No data were collected from individual human subjects. Analyses included all available data on healthy and regular snack vends. Data from Baseline 1 and Baseline 2 were combined into a single arm/group (Baseline) in statistical analyses."|||proportion of vends from healthy snacks|Vends||Number
1317565|NCT02359903|Other Pre-specified|Area Under the Plasma Concentration-time Curve at Steady State Phase||28 weeks||2016-12-31|12/2016||||
1317566|NCT02359903|Other Pre-specified|Maximum Concentration at Steady State||28 weeks||2016-12-31|12/2016||||
1317567|NCT02359903|Secondary|Frequency of Early Withdrawal Due to AE/SAE||30 weeks|||||||
1317568|NCT02359903|Secondary|Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected||screening / 14 weeks / 30 weeks|||||||
1317569|NCT02359903|Secondary|Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study||30 weeks|||||||
1317570|NCT02359903|Secondary|Total Frequency of AE/SAE Within the Whole Time of the Study||30 weeks|||||||
1317571|NCT02359903|Secondary|Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade||2 weeks|||||||
1317572|NCT02359903|Secondary|Mean Change of Chest Expansion Compared With Baseline||14 weeks / 30 weeks|||||||
1317573|NCT02359903|Secondary|Mean Change of SF36 Score Compared With Baseline||14 weeks / 30 weeks|||||||
1317574|NCT02359903|Secondary|Mean Change of MASES Score Compared With Baseline||14 weeks / 30 weeks|||||||
1317575|NCT02359903|Secondary|Mean Change of BASFI Score Compared With Baseline||14 weeks / 30 weeks|||||||
1317576|NCT02359903|Secondary|Mean Change of BASMI Score Compared With Baseline||14 weeks / 30 weeks|||||||
1317577|NCT02359903|Secondary|Mean Change of BASDAI Score Compared With Baseline||14 weeks / 30 weeks|||||||
1317578|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS40||14 weeks / 30 weeks|||||||
1317579|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS20||14 weeks / 30 weeks|||||||
1317580|NCT02359903|Secondary|Average Concentration of Infliximab at Steady State Phase||28 weeks|||||||
1317581|NCT02359903|Secondary|Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade||2 weeks / 28 weeks|||||||
1317582|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks|||||||
1317583|NCT02359903|Secondary|Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks|||||||
1317584|NCT02359903|Secondary|Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks|||||||
1317585|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade||2 weeks|||||||
1317586|NCT02359903|Secondary|Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.|2 weeks||||ng/ml||Inter-Quartile Range|Median
1317587|NCT02359903|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade||2 weeks|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.|||(ng/ml)*hour||Inter-Quartile Range|Median
1317588|NCT02359890|Secondary|Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)|The freedom from documented AF/AT/AFL based on electrocardiographic data|12 months|Effectiveness per Protocol Population, which is defined as enrolled subjects who underwent RF ablation procedure with study catheter and completed the 12 month visit.|||Percentage of Participants||95% Confidence Interval|Number
1317589|NCT02359890|Secondary|Percentage of Participants With Acute Success|Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).|End of procedure|Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.|||Percentage of participants||95% Confidence Interval|Number
1317590|NCT02359890|Secondary|Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)|This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure|Up to 30 days post Procedure|Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.|||Percentage of Participants|||Number
1317608|NCT02359305|Primary|Average FLACC Pain Score in the PACU|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain.|0-60 minutes post-operatively||||units on a scale 0-10||Standard Deviation|Mean
1317591|NCT02359890|Primary|Percentage of Participants With Early Onset Primary Adverse Events|Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.|Seven days post ablation procedure|The modified intent-to-treat (mITT) population was used, which consisted of enrolled subjects who met the eligibility criteria and had the study catheter inserted.|||Percentage of participants||95% Confidence Interval|Number
1317592|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM|Stage 2 BCD-054 - 180 mcg - SC/IM|4 weeks||||participants|||Number
1317593|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Stage 1|4 weeks||||participants|||Number
1317594|NCT02359877|Primary|AUC(0-∞), AUC(0-last) of Neopterin|Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration|0 to 672 hours||||(nmol/L)*hour||Inter-Quartile Range|Median
1317595|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin|Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively||||nmol/L*hour||Inter-Quartile Range|Median
1317596|NCT02359877|Primary|AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM|Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration|0 to 672 hours||||(pg/ml)*hour||Inter-Quartile Range|Median
1317597|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a|Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively||||(pg/ml)*hour||Inter-Quartile Range|Median
1317598|NCT02359851|Other Pre-specified|Changes in Molecular Characteristics of Uveal Melanoma When Treated With Pembrolizumab|Each relevant clinical characteristic will be recorded by the use of tables and/or graphs. The number and percentage of patients treated, and the primary reason for discontinuation will be displayed. Demographic variables (such as age) and baseline characteristics will be summarized by descriptive statistics. Compliance with pembrolizumab administration will be measured by patients: 1) receiving unscheduled study agent infusions/injections; 2) missing an infusion/injection. Numbers and percentages of patients and infusion/injection visits with any deviation in these measures will be reported.|Baseline up to 2 years|||||||
1317599|NCT02359851|Other Pre-specified|Change in PD-L1 Expression Status on Archival or Fresh Tissue From All Patients and Correlate With ORR|Differences in PFS and OS between subgroups will be assessed by the stratified logrank test. Differences in ORR between subgroups will be assessed by the Pearson chi-square test. No adjustments will be made for multiple comparisons.|Baseline up to 2 years|||||||
1317600|NCT02359851|Other Pre-specified|Changes in GNAQ/GNA11 Mutation Status on Each Patient Per Institutional Protocol|Differences in PFS and OS between subgroups will be assessed by the stratified logrank test. Differences in ORR between subgroups will be assessed by the Pearson chi-square test. No adjustments will be made for multiple comparisons.|Baseline up to 2 years|||||||
1317601|NCT02359851|Secondary|Number of Patients With Each Worst‐Grade Toxicity. Incidence of Adverse Events, Using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death. This endpoint will be reported descriptively without formal statistical analysis.|Up to 30 days after the last dose of trial treatment||||Participants|||Count of Participants
1317602|NCT02359851|Secondary|Response Duration|If sample size permits, response duration will be summarized descriptively using Kaplan-Meier medians and quartiles. Only the subset of patients who show a complete response or partial response will be included in this analysis.|Up to 3 years|Only 1 participant had a RECIST-defined response, which is ongoing and lasting 23.5 months.|||months|||Number
1317603|NCT02359851|Secondary|Overall Survival (OS) Defined as Number of Patients Surviving up to 3 Years.|The Kaplan-Meier method will be used to estimate the overall survival. Median survival and its 95% confidence interval will be estimated and reported.|Interval between the first dose of pembrolizumab and death for any reason, assessed up to 3 years|Patients received pembrolizumab treatment.|||Participants|||Count of Participants
1317604|NCT02359851|Secondary|Progression-Free Survival (PFS) Defined as Time From Treatment to Progression Defined by RECIST1.1 Criteria or Death.|PFS will be summarized using the method of Kaplan and Meier. Median PFS time with 95% confidence intervals will be reported. Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), progression will be defined as ≥ 20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest diameter recorded or the appearance of one or more new lesions, and/or appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.|Time from the first dose of pembrolizumab to progression, assessed up to 3 years.|Patients received treatment.|||months||95% Confidence Interval|Median
1317605|NCT02359851|Primary|Objective Response Rate (ORR), Defined as the Percentage of Patients Achieving a Confirmed Complete or Partial Response, as Defined by Immune-related Response Criteria (irRC)|Of note, response rates by RECIST 1.1 criteria will also be assessed although irRC will be used for the primary endpoint. The percentage of complete or partial response is calculated and 95% confidence interval is estimated using Wilson method.|Up to 3 years|Patients received pembrolizumab treatment and evaluated for response.|||% of patients achieving response||95% Confidence Interval|Mean
1317606|NCT02359435|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy|Intention to treat|||participants|||Number
1317611|NCT02359110|Secondary|VAS (Visual Analog Scale)|"The VAS is scored using a horizontal line 100mm in length. The scale is anchored by no pain (score of 0) and worst pain (score of 100)."|2 -6 hours|Our analysis uses all available data. Some participants were not in house for the full 6 hours of collection, others did not complete VAS at the respective time point. Therefore the number at each time point differs from the overall number of participants.|||units on a scale||95% Confidence Interval|Least Squares Mean
1317612|NCT02359110|Primary|NRS (Numerical Rating Scale)|The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.|2-8 hours|Our analysis uses all available data. Some participants were not in house for the full 8 hours of collection, others did not complete NRS at the respective time point. Therefore the number at each time point differs from the overall number of participants.|||units on a scale||95% Confidence Interval|Least Squares Mean
1317613|NCT02359058|Secondary|Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)|Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.|First dose to study completion plus 30-day safety follow-up (Up To 22 Months)|All enrolled participants who received at least one dose of the study drug and had evaluable immunogenicity data.|||Participants|||Count of Participants
1317614|NCT02359058|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.|First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)|All enrolled participants who received at least one dose of study drug and with measurable disease.|||Percentage of participants|||Number
1317615|NCT02359058|Secondary|Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab|Minimum Serum Concentration (Cmin) of Ramucirumab.|Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose|All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1317616|NCT02359058|Secondary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab|Maximum Serum Concentration (Cmax) of Ramucirumab.|Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion|All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317617|NCT02359058|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)|All enrolled participants who received at least one dose of study drug.|||Participants|||Count of Participants
1317618|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Urinalysis|To evaluate the safety by assessing the number of subjects with clinically significant urinalysis results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
1317619|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Clinical Chemistry Laboratory Results|To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
1317620|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Hematology Parameters|To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
1317621|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant 12-lead Electrocardiograms (ECGs)|To evaluate the safety by assessing the number of subjects with clinically significant 12-lead ECGs after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
1317622|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Pulse|To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
1317657|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
1317623|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Blood Pressure|To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
1317624|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event|To assess the safety by analyzing the number of subjects with at least one adverse event after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing.|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Partcipants|||Number
1317625|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events|To assess the safety summary of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
1317626|NCT02359045|Secondary|λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(1/h)||Geometric Coefficient of Variation|Geometric Mean
1317627|NCT02359045|Secondary|λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(1/h)||Geometric Coefficient of Variation|Geometric Mean
1317628|NCT02359045|Secondary|Terminal Elimination Rate Constant (λz ) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(1/hour)||Geometric Coefficient of Variation|Geometric Mean
1317629|NCT02359045|Secondary|Tmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Full Range|Median
1317630|NCT02359045|Secondary|Tmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Full Range|Median
1317658|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
1317659|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317631|NCT02359045|Secondary|Time to Reach Maximum Observed Concentration (Tmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Full Range|Median
1317632|NCT02359045|Secondary|t½λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Geometric Coefficient of Variation|Geometric Mean
1317633|NCT02359045|Secondary|t½λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Geometric Coefficient of Variation|Geometric Mean
1317634|NCT02359045|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Geometric Coefficient of Variation|Geometric Mean
1317635|NCT02359045|Secondary|C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
1317636|NCT02359045|Secondary|C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317637|NCT02359045|Secondary|Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317660|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317638|NCT02359045|Secondary|AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1317639|NCT02359045|Secondary|AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1317640|NCT02359045|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration {AUC (Last)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1317641|NCT02359045|Primary|Cmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
1317642|NCT02359045|Primary|Cmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317643|NCT02359045|Primary|Maximum Observed Plasma Concentration (Cmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317644|NCT02359045|Primary|AUC (0-72) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1317680|NCT02358668|Secondary|Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||cm||Standard Deviation|Mean
1317645|NCT02359045|Primary|AUC (0-72) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1317646|NCT02359045|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours After Dosing {AUC(0-72)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1317647|NCT02359045|Primary|AUC Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1317648|NCT02359045|Primary|AUC Assessed for Docosahexaenoic Acids (DHA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1317649|NCT02359045|Primary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC) Assessed for Eicosapentaenoic Acid (EPA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1317650|NCT02358876|Primary|Percentage of Kinesia One Assessments Performed|Percentage of Kinesia One assessments performed as directed|Two weeks||||percentage of home assessments completed||Standard Deviation|Mean
1317651|NCT02358863|Primary|The Proportion of Patients With Tumor Size Reduction (Objective Response Rate)|Objective response rate is the sum of partial responses plus complete responses.|1 year||||Participants|||Count of Participants
1317652|NCT02358668|Other Pre-specified|Changes in Complete Blood Count in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 4, Week 8, Week 12, and Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||g/dL||Standard Deviation|Mean
1317653|NCT02358668|Other Pre-specified|Changes in Measures of Liver Function in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 4, Week 8, Week 12, and Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320.|||IU/L||Standard Deviation|Mean
1317654|NCT02358668|Other Pre-specified|Changes in Serum Creatinine in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||umol/L||Standard Deviation|Mean
1317655|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
1317656|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
1317661|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317662|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317663|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Maximum Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317664|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Post-prandial Maximum Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317665|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16||||mmol/L||95% Confidence Interval|Mean
1317666|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 3 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317667|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 2 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317668|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 1 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
1317669|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 3 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||95% Confidence Interval|Mean
1317670|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 2 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||95% Confidence Interval|Mean
1317671|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 1 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||95% Confidence Interval|Mean
1317672|NCT02358668|Secondary|Changes in Measures of Exercise in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in the number of days per week that the subject spent walking for at least 10 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||Days||Standard Deviation|Mean
1317673|NCT02358668|Secondary|Changes in Measures of Nutritional Intake in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in daily calories intake from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||kcal||Standard Deviation|Mean
1317674|NCT02358668|Secondary|Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|"Changes to question of how full do you feel in the Appetite Questionnaire adopted from Hill and Blundell from baseline and Week 16. Scale score ranges from minimum of 0 to maximum of 10. 10 being the most full and 0 being the least full."|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||units on a scale||Standard Deviation|Mean
1317675|NCT02358668|Secondary|Changes in Quality of Life Measures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in WHOQOL-BREF physical health domain score from baseline to Week 16. This is a sub-scale of the WHOQOL-BREF. Possible scores range from minimal of 4 to maximum of 20. Higher score indicate better physical health domain.|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||units on a scale||Standard Deviation|Mean
1317676|NCT02358668|Secondary|Changes in Urate in Subjects Treated With High Dose and Lose Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
1317677|NCT02358668|Secondary|Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mg/L||Standard Deviation|Mean
1317678|NCT02358668|Secondary|Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in total cholesterol from baseline to Week 16.|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
1317679|NCT02358668|Secondary|Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||kg||Standard Deviation|Mean
1317682|NCT02358668|Secondary|Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group|Proportion of subjects with impaired fasting glucose, impaired glucose tolerance, both impaired fasting glucose and impaired glucose tolerance, HbA1c 5.7-6.4%, or type 2 diabetes at 30 days post-treatment|From baseline to 30 days post-treatment|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||percentage of subjects|||Number
1317683|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Glucagon-like Peptide 1 During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of glucagon-like peptide-1 from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||pmol/L*minute||Standard Deviation|Mean
1317684|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of C-peptide During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of C-peptide from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||ug/L*minute||Standard Deviation|Mean
1317685|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Insulin During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of insulin from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mIU/L*minute||Standard Deviation|Mean
1317686|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Glucose During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of glucose from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*minute||Standard Deviation|Mean
1317687|NCT02358668|Secondary|Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||umol/L||Standard Deviation|Mean
1317688|NCT02358668|Secondary|Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||percent glycated hemoglobin||Standard Deviation|Mean
1317689|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||Standard Deviation|Mean
1317690|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
1317691|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve for Glucose Levels >180mg/dL on Continuous Glucose Monitoring System|Area under curve for glucose levels >180 mg/dL over 72 hours|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||Standard Deviation|Mean
1317692|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
1317693|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Amplitude of Glucose Excursion on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
1317694|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose BTI320 and High Dose BTI320 Compared With Placebo in Mean Post-meal Maximum Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
1317695|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System|"Changes in 3-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system from baseline to Week 16.~Note that this is not a pharmacokinetic study and this is not pharmacokinetic data as we are not measuring drug levels. Here we are examining glucose levels after meals as one of the anticipated glycemic outcomes of using glucose-lowering therapy (BTI320 in this case). With data-analysis based on continuous glucose monitoring, it is conventional to present post-prandial (i.e. post-meal) glucose incremental area under curve at up to 3 hours. It is not meaningful to look at post-meal glucose changes at more than 3 hours after meal for the obvious reason that subject might have taken another meal by then."|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||Standard Deviation|Mean
1317696|NCT02358668|Primary|Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 4|Intention to treat, as defined by all subjects who have received at least one dose of BTI320.|||umol/L||Standard Deviation|Mean
1317697|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy.|4 weeks after end of all therapy (Study Week 16)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1317882|NCT02354599|Primary|Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
1317698|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
1317699|NCT02358044|Secondary|Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days|Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
1317700|NCT02358044|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.~The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial."|Up to Week 12|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
1317701|NCT02358044|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|All Subjects as Treated (ASaT) population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
1317702|NCT02358044|Primary|Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)|Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study was that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was non-inferior to the percentage in the SOF plus PR arm. A secondary statistical analysis was performed to determine whether the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was superior to the percentage in the SOF plus PR arm.|12 weeks after end of all therapy (Study Week 24)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
1317703|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 14|Percentage of adults and babies with scaling on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317704|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 14|Percentage of adults and babies with scaling on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317705|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 14|Percentage of adults and babies with scaling on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317706|NCT02357940|Primary|Percentage With Scaling on the Face at Day 14|Percentage of adults and babies with scaling on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317707|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 7|Percentage of adults and babies with scaling on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317708|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 7|Percentage of adults and babies with scaling on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317883|NCT02354599|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
1317711|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 1|Percentage of adults and babies with scaling on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317712|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 1|Percentage of adults and babies with scaling on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317713|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 1|Percentage of adults and babies with scaling on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317714|NCT02357940|Primary|Percentage With Scaling on the Face at Day 1|Percentage of adults and babies with scaling on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317715|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317716|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317717|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317718|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317719|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317720|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317721|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317722|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317723|NCT02357940|Primary|Percentage With Edema on the Torso at Day 14|Percentage of adults and babies with edema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317724|NCT02357940|Primary|Percentage With Edema on the Legs at Day 14|Percentage of adults and babies with edema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317725|NCT02357940|Primary|Percentage With Edema on the Arms at Day 14|Percentage of adults and babies with edema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317726|NCT02357940|Primary|Percentage With Edema on the Face at Day 14|Percentage of adults and babies with edema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317727|NCT02357940|Primary|Percentage With Edema on the Torso at Day 7|Percentage of adults and babies with edema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317728|NCT02357940|Primary|Percentage With Edema on the Legs at Day 7|Percentage of adults and babies with edema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317729|NCT02357940|Primary|Percentage With Edema on the Arms at Day 7|Percentage of adults and babies with edema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317730|NCT02357940|Primary|Percentage With Edema on the Face at Day 7|Percentage of adults and babies with edema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317731|NCT02357940|Primary|Percentage With Edema on the Torso at Day 1|Percentage of adults and babies with edema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317735|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317736|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317737|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317738|NCT02357940|Primary|Percentage With Edema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317739|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317740|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317741|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317742|NCT02357940|Primary|Percentage With Edema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317743|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 14|Percentage of adults and babies with erythema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317744|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 14|Percentage of adults and babies with erythema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317745|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 14|Percentage of adults and babies with erythema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317746|NCT02357940|Primary|Percentage With Erythema on the Face at Day 14|Percentage of adults and babies with erythema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317747|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 7|Percentage of adults and babies with erythema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317748|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 7|Percentage of adults and babies with erythema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317749|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 7|Percentage of adults and babies with erythema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317750|NCT02357940|Primary|Percentage With Erythema on the Face at Day 7|Percentage of adults and babies with erythema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317751|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 1|Percentage of adults and babies with erythema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317752|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 1|Percentage of adults and babies with erythema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317753|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 1|Percentage of adults and babies with erythema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317754|NCT02357940|Primary|Percentage With Erythema on the Face at Day 1|Percentage of adults and babies with erythema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317755|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317756|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317757|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317758|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317759|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317760|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317761|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317762|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
1317763|NCT02357901|Secondary|Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24|The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. The C-SSRS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.|Weekly - Week 2 through Week 24|Safety analysis set of participants who completed a C-SSRS during the treatment period.|||Participants|||Count of Participants
1317764|NCT02357901|Secondary|Worst Injection Site Pain From Injections 1-6 as Measured by Participant-Reported Visual Analog Scale (VAS)|"Injection site pain as measured by participant-reported VAS The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' on the left end and 'strongest pain ever' on the right end of the scale (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.~The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30, 60 and 120 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.~Data represents the worst pain recorded for each participant across all 6 injections and all VAS records. The mean value is presented."|Days 1, 29, 57, 85, 113, 141|Safety population|||units on a scale||Standard Deviation|Mean
1317765|NCT02357901|Secondary|Participants With Adverse Events During the Treatment Period|Treatment-emergent adverse event (TEAE) = any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition.|Day 1 through Week 24|Safety analysis set|||Participants|||Count of Participants
1317766|NCT02357901|Secondary|Total Number of Weeks of Abstinence as Assessed From Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24|The total number of weeks of abstinence was assessed from urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24. All missing reports for opioids were considered non-negative.|Weeks 5 through 24|Full analysis set|||weeks||Standard Error|Least Squares Mean
1317767|NCT02357901|Secondary|Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The SOWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate."|Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
1317884|NCT02354599|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
1317768|NCT02357901|Secondary|Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures|"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The COWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate."|Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
1317769|NCT02357901|Secondary|Change From Baseline in the Clinical Global Impression - Severity Scale (CGI-S) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The CGI-S was an assessment completed by the clinician to rate the severity of symptoms on an ordinal scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects; pathology drastically interferes in many life functions). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment.~Negative change from baseline values indicate an improvement in the severity of symptoms.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect."|Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
1317770|NCT02357901|Secondary|Change From Baseline in the Clinical Global Impression - Improvement Scale (CGI-I) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The CGI-I was used to rate the change in clinical status since the start of the treatment on an ordinal scale ranging from 1 (very much improved; nearly all better; good level of functioning; minimal symptoms; represents a very substantial change) to 7 (very much worse; severe exacerbation of symptoms and loss of functioning). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment.~Negative change from baseline values indicate an improved clinical global impression.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect."|Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
1317771|NCT02357901|Secondary|Participants Who Are Abstinent at Week 24|Participants with both a negative urine sample and negative self-report for illicit opioid use at Week 24.|Week 24|Full analysis set|||Participants|||Count of Participants
1317772|NCT02357901|Secondary|"Participants Who Complete the Week 24 Visit (Completers)"|A completer was defined as a participant who completed either the urine drug screen (UDS) or Timeline Followback (TLFB) assessment at the Week 24 visit.|Week 24|Full analysis set|||Participants|||Count of Participants
1317773|NCT02357901|Secondary|Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The opioid craving scale was a 100 mm scale with 0= 'no craving' on the left end and 100= 'strongest craving ever' on the right end of the scale. Participants marked where along the scale reflected their craving for opioids. The full range of the change from baseline scale was therefore 100 (no craving at baseline, strongest craving during study) to -100 (strongest craving at baseline, no craving during study).~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The opioid craving VAS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Negative change from baseline values indicate a lessening of craving symptoms.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect."|Baseline: Day 1 (prior to dosing), Weeks 5-24|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
1317774|NCT02357901|Secondary|Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24|Data represent the count of participants at various percentage levels in which self-reports were negative for illicit use of opioids. Self-reports were obtained from Timeline Followback (TLFB) interviews. All missing self-reports were considered non-negative.|Weekly from Weeks 5-24|Full analysis set|||Participants|||Count of Participants
1317775|NCT02357901|Secondary|Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24|Data represent the count of participants at various percentage levels in which urine samples tested negative for opioids. All missing reports for urine samples were considered non-negative.|Weekly from Weeks 5-24|Full analysis set|||Participants|||Count of Participants
1317776|NCT02357901|Secondary|Percentage of Participants Considered A Treatment Success|Treatment success is defined as a participant having ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use between weeks 5-24.|Weeks 5-24|Full analysis set|||percentage of participants|||Number
1317885|NCT02354599|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
1317777|NCT02357901|Primary|Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24|Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The primary endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. Missing urine drug screen(s) (UDS) samples and/or self-reports were considered as non-negative.|Weekly from Weeks 5-24|Full analysis set|||Participants|||Count of Participants
1317778|NCT02357485|Secondary|Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).|Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.|baseline to 3 months||||seconds||Standard Deviation|Mean
1317779|NCT02357485|Secondary|Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion|Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.|Baseline to 3 months||||degrees|Participants|Standard Deviation|Mean
1317780|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain|Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).|Baseline to 1 year||||units on a scale|Participants|Standard Deviation|Mean
1317781|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|"Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment).~WOMAC score: 0 (best) to 100 (worst)"|Baseline to 1 year||||units on a scale|Participants|Standard Deviation|Mean
1317782|NCT02357485|Primary|Safety as Measured by Adverse Events|Adverse Events were recorded during the entirety of the study.|Entire Study (1 year)|All 6 participants were included in the analysis|||percentage of participants|||Number
1317783|NCT02357459|Other Pre-specified|Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)||Weeks 1-24||||tablets (1 tablet = 500 mg)||Standard Error|Least Squares Mean
1317784|NCT02357459|Other Pre-specified|Time to Onset of Pain Relief|Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline|Baseline to >30% improvement (measured up to 30 days)||||days||95% Confidence Interval|Median
1317785|NCT02357459|Other Pre-specified|Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)||Weeks 1-24||||Participants|||Count of Participants
1317786|NCT02357459|Other Pre-specified|Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 1-24||||Participants|||Count of Participants
1317787|NCT02357459|Other Pre-specified|Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24|"The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient’s opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL).~A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life."|Weeks 4, 8, 12, and 24||||units on a scale||Standard Error|Least Squares Mean
1317788|NCT02357459|Other Pre-specified|Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Weeks 4, 8, 12, 16, 20 and 24||||units on a scale||Standard Error|Least Squares Mean
1317789|NCT02357459|Other Pre-specified|Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Weeks 4, 8, 12, 16, 20 and 24||||units on a scale||Standard Error|Least Squares Mean
1317790|NCT02357459|Other Pre-specified|Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Weeks 4, 8, 12, 16, 20, and 24||||units on a scale||Standard Error|Least Squares Mean
1317791|NCT02357459|Other Pre-specified|Change From Baseline to Each Week in Weekly Mean of the ADP Scores|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 1-11 & Weeks 13-24||||units on a scale||Standard Error|Least Squares Mean
1317792|NCT02357459|Secondary|AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline to 24 Weeks|AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for TCA IR 40 mg Relative to Placebo was not a pre-specified Secondary Outcome and therefore not reported|||ADP Pain Scores * Week||Standard Error|Least Squares Mean
1317793|NCT02357459|Secondary|Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline through 12 Weeks||||units on a scale||Standard Error|Least Squares Mean
1317794|NCT02357459|Secondary|AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline to 12 Weeks||||ADP Pain Scores * Week||Standard Error|Least Squares Mean
1317795|NCT02357459|Secondary|Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline to 12 Weeks|Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm|||ADP Pain Scores * Week||Standard Error|Least Squares Mean
1317796|NCT02357459|Primary|Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline and 12 Weeks|Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm.|||units on a scale||Standard Error|Least Squares Mean
1317797|NCT02357342|Secondary|Visual Acuity (Best Corrected Visual Acuity)|number of subjects with gain of 5 or more letters of visual acuity|baseline to 6 months||||participants||100% Confidence Interval|Number
1317798|NCT02357342|Primary|Visual Acuity|number of subjects with gain of 0-4 letters of visual acuity|Baseline to 6 months||||Participants|||Count of Participants
1317799|NCT02357342|Primary|Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography|Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group|Baseline to 6 months||||microns||Full Range|Mean
1317800|NCT02357264|Primary|Detection of Fluid in the Lungs|Detection of Fluid in the lungs in patients with pre-eclampsia vs. pregnant patients without pre-eclampsia|24-36 weeks||||Participants|||Count of Participants
1317801|NCT02357173|Primary|Point Prevalence Abstinence|% of participants with CO-verified cigarette abstinence at study week 16|week 16||||percentage of participants|||Number
1317802|NCT02357173|Primary|% Quit Attempts|% of participants who made any quit attempt during study|study enrollment to study week 16||||percentage of participants|||Number
1317803|NCT02357173|Primary|Independent Purchase of an ENDs Product|% of participants by group who purchased an ENDs product on their own during the study|study enrollment to study week 16||||percentage of participants|||Number
1317804|NCT02357173|Primary|Uptake of Electronic Nicotine Delivery Systems (ENDS)|% of participants by group used e-cigarettes in week 16|study week 16||||percentage of participants|||Number
1317805|NCT02356900|Primary|Muscle Phenotype Change|Immunofluorescence microscopy using citrate synthase staining|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
1317806|NCT02356900|Primary|COX-I Gene Expression Change|Real-time PCR|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
1317807|NCT02356900|Primary|Pgc-1a Coactivator Muscle Protein Content Change|Western analysis|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
1317808|NCT02356900|Primary|Tfam Muscle Protein Content Change|Western analysis|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
1317809|NCT02356900|Primary|Mitochondrial Mass Change|Immunofluorescence microscopy using citrate synthase staining|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
1317810|NCT02356900|Primary|Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)|Graded exercise test to exhaustion at simulated 15000 ft altitude|Baseline and <72 hrs Post-training|Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.|||mL/kg/min||Standard Deviation|Mean
1317811|NCT02356900|Primary|Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )|Graded exercise test to exhaustion at simulated 15000 ft altitude|Baseline and <72 hrs Post-training|Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.|||mL/kg/min||Standard Deviation|Mean
1317812|NCT02356783|Primary|Percentage of Patients With Available Step Count Data Post-procedure.|Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure.|Duration of 60 days after procedure.||||percentage of patients with step data|||Number
1317813|NCT02356783|Primary|Percentage of Patients With Available Step Count Data at Baseline.|Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer.|A week pre-procedure.||||percentage of patients with step data|||Number
1317814|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 24 hours||||mean number of doses used||Standard Deviation|Mean
1317815|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 12 hours||||mean number of doses used||Standard Deviation|Mean
1317816|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 6 hours||||mean number of doses used||Standard Deviation|Mean
1317819|NCT02356588|Secondary|Summed Pain Intensity Difference|"The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour.~The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|1 hour||||units on a scale||Standard Error|Least Squares Mean
1317820|NCT02356588|Secondary|Healthcare Professional Global Assessment|Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours||||Percentage of HCPs||95% Confidence Interval|Number
1317821|NCT02356588|Secondary|Patient Global Assessment|Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours||||Percentage of patients||95% Confidence Interval|Number
1317822|NCT02356588|Secondary|Time-weighted SPRID24|Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|24 hours||||units on a scale||Standard Error|Least Squares Mean
1317823|NCT02356588|Secondary|Time-weighted SPRID12|Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|12 hours||||units on a scale||Standard Error|Least Squares Mean
1317824|NCT02356588|Secondary|TOTPAR24|Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief.|24 Hours||||units on a scale||Standard Error|Least Squares Mean
1317825|NCT02356588|Secondary|TOTPAR12|Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief.|12 hours||||units on a scale||Standard Error|Least Squares Mean
1317826|NCT02356588|Secondary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).|The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|24 hours||||units on a scale||Standard Error|Least Squares Mean
1317827|NCT02356588|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).|"The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.~The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|12 hours||||units on a scale||Standard Error|Least Squares Mean
1317828|NCT02356562|Secondary|Percentage of Participants With Post-Treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last actual dose of active study drug|All participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the end of treatment and completed treatment. Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
1317829|NCT02356562|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.|Up to week 24|All participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
1317830|NCT02356562|Secondary|Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug|12 weeks after the last dose of active drug|All Part 2 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
1317831|NCT02356562|Primary|Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last dose of active drug|All Part 1 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
1317832|NCT02356471|Secondary|Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).|The fatigue VAS is a unidimensional measure of fatigue providing a range of scores from 0-100. A higher score indicates greater fatigue. Change in median (IQR) fatigue score from baseline to 90 days is reported.|baseline and 90 days|Only 6 subjects reported fatigue VAS at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
1317833|NCT02356471|Secondary|Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)|The pain VAS is a unidimensional measure of pain intensity providing a range of scores from 0–100. A higher score indicates greater pain intensity. Change in median (IQR) pain score from baseline to 90 days is reported.|baseline and 90 days|Only 6 subjects had pain VAS measured at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
1317834|NCT02356471|Secondary|Change in Health-related Quality of Life (FACT-G) Questionnaire|FACT-G is a 27-item compilation of general questions divided into 4 primary quality of life (QOL) domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The subscales are summed to produce a total score. The total score range is 0-108 and a higher score indicates better quality of life. Outcomes is to compare FACT-G at baseline and 90 days. Change in FACT-G is reported in median (IQR).|baseline and 90 days|Only 6 subjects reported FACT-G at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
1317835|NCT02356471|Secondary|Change in CHAMPS Between the Pre- and Post-operative Period|This outcome measure is to compare self-reported activity data (CHAMPS) during the pre- and post-operative period. Median (IQR) change in CHAMPS is reported. CHAMPS measures activity of the participant and how long they could do the activity. The score range is 0-108. Higher scores denotes better outcomes.|baseline and 90 days|5 subjects have CHAMPs data at baseline and 90 days.|||Times per week||Inter-Quartile Range|Median
1317836|NCT02356471|Secondary|Change in the Mobility Assessment Tool-Short Form (MAT-sf).|This outcome measure is to compare pre- and post-operative self-reported mobility using the Mobility Assessment Tool-Short Form (MAT-sf). Median (IQR) change in MAT-sf is reported. The score range is 30-80 and higher scores denotes better outcomes.|baseline and 90 days|Only 7 subjects had MAT-sf measured at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
1317837|NCT02356471|Secondary|Change in Pepper Assessment Tool for Disability (PAT-D)|This outcome measure is to compare pre- and post-operative self-reported mobility using the Pepper Assessment Tool for Disability (PAT-D). Median (IQR) change in PAT-D is reported.|baseline and 90 days|Data were not collected and therefore analysis cannot performed.||||||
1317838|NCT02356471|Secondary|Change in Duration of 400-meter Walk|This outcome measure is to compare pre- and post-operative mobility testing using the 400-meter walk. Median (IQR) change in 400 m walk from baseline to 90 days is reported. The duration it takes the participant to walk 400 meters will be recorded in seconds.|baseline and 90 days|Only 10 subjects had 400m walk measured at baseline and 90 days|||seconds||Inter-Quartile Range|Median
1317839|NCT02356471|Secondary|Change in Short Physical Performance Battery (SPPB)|This outcome measure is to compare pre- and post-operative mobility using the Short Physical Performance Battery (SPPB). Median (IQR) change in SPPB from baseline to 90 days is reported.The scale range is 0-16. Higher scores denotes better outcomes.|baseline and 90 days|Only 9 subjects had SPPB measured at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
1317840|NCT02356471|Secondary|Change in Daily Steps for Participants Before and After Major Oncologic Surgery|This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported.|baseline and 90 days|16 subjects had sufficient data for partial analysis.|||steps||Inter-Quartile Range|Median
1317841|NCT02356471|Primary|Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period|Feasibility will be defined as the number of patients who self-report wearing the CAM device at least 16 days of the 21 day period.|90 days|34 patients enrolled in study. 28 patients had data collected. Due to challenges associated with data collection, partial data was collected for 18 patients.|||Participants|||Count of Participants
1317842|NCT02356107|Primary|Change From Baseline in Hamilton Depression Rating Scale|The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression. HAM-D (outcome measure) was used to assess the level of depression at baseline and after 8 weeks of using the study drug. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.|8 weeks||||units on a scale||Standard Deviation|Mean
1317843|NCT02355977|Secondary|Bacterial Load|Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.|7 days|The analyzed units of the gene load of bacteria are log10.|||log10 (copies/ml)||Standard Deviation|Mean
1317844|NCT02355977|Secondary|Bleeding on Probing|BOP is evaluated for the treated tooth using the sulcus bleeding index (SBI) by Muhlemann with a range of 0 (no bleeding) to 5 (profuse bleeding)|7 days||||units on a scale||Standard Deviation|Mean
1317845|NCT02355977|Primary|Pocket Depth|PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.|7 days||||mm||Standard Deviation|Mean
1317846|NCT02355743|Secondary|Need for Central Line Replacement|This will be defined as a line removal and replacement due to infection, malfunction or other issues|24 weeks||||line replacements||Inter-Quartile Range|Median
1317847|NCT02355743|Secondary|Development of Line-associated Infection|This will be defined as a line associated infection not related to other co-infection (i.e. such as pneumonia, UTI)|24 weeks||||infections||Inter-Quartile Range|Median
1317848|NCT02355743|Primary|Development of CVAD Line Thrombosis|This will be defined as a thrombosis that is discovered due to clinical findings concerning for a possible thrombosis as identified by the treating physician including, but not limited to, swelling, color change, or pain in the extremity, CVAD not providing blood return and/or being able to be flushed.|24 weeks||||thromboses||Full Range|Mean
1317849|NCT02355691|Secondary|Number of Participants With Infection|"The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection.~Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism~Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields"|(Single point evaluation)-6 weeks post surgery visit|Measured all that enrolled and completed the treatment|||Participants|||Count of Participants
1329611|NCT02107014|Primary|Change in IL-12p70 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1317850|NCT02355691|Primary|Mean Wound Healing Scores by the ASEPSIS Criteria|A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.|(Single point evaluation)-2 weeks post surgery visit|Measured outcomes for all patients that completed the treatment|||units on a scale||Full Range|Mean
1317851|NCT02355275|Secondary|Numeric Pain Rating Scale|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain. This was measured at baseline (T1) and 4 weeks (T2)|4 weeks||||units on a scale||Full Range|Mean
1317852|NCT02355275|Primary|Oswestry Disability Index|Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The score is calculated by totaling the values marked, divided by 50 x 100. The greater the score the greater the disability. For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound. This outcome measure was reported at baseline (T1) and 4 weeks later (T2).|4 weeks||||units on a scale||Full Range|Mean
1317853|NCT02355158|Primary|Summary of Neuropathic Pain Symptom Inventory (NPSI)|The NPSI is a validated, self-administered questionnaire designed to evaluate the different symptoms of neuropathic pain. Each item is quantified on an 11-point (0-10) numeric scale. The NPSI includes 10 descriptors (plus 2 temporal items) that allow discrimination and quantification of 5 distinct clinically relevant dimensions of neuropathic pain syndromes. The Neuropathic Pain Symptom Inventory (NPSI) is a self-questionnaire designed to evaluate the different symptoms of neuropathic pain, which contains a list of descriptors reflecting spontaneous ongoing or paroxysmal pain, evoked pain (i.e., mechanical and thermal allodynia/hyperalgesia) and dysesthesia/paresthesia. Each of these items is quantified on an 11-point (0-10) numerical scale. NPSI total score was calculated and summarized descriptively at month 12 or the subjects last visit. The total score was calculated and summarized.|Month 12 or last visit|While 197 subjects received study drug, 172 completed the NPSI at the week 12 visit or at their last visit.|||units on a scale||Standard Deviation|Mean
1317854|NCT02355028|Secondary|Plasma Concentration of LHA510 and CRA398|Samples collected from subjects, after multiple topical ocular dosing of LHA510, were analyzed to determine concentrations of LHA510 and its metabolite, CRA398. Plasma LHA510 and CRA398 concentrations were quantitated by a validated liquid chromatography-tandem mass spectroscopy assay method. Below the limit of quantification (BLQ) is treated as zero.|Day 28, Day 84|This analysis population includes all subjects who were treated with LHA510, had at least 1 serum sample following exposure to the IP, and had no known specimen collection or analytical deviations, as identified by the Pharmacokineticist, that would have affected the integrity of the data [Pharmacokinetics (PK) Analysis Set].|||ng/mL||Standard Deviation|Mean
1317855|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in CNV Size by Visit|The size of CNV (area of new blood vessels in the choroid layer of the retina) was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in CNV size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 84|Extended PPS-A4 as observed|||mm^2||Standard Deviation|Mean
1317856|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Total Lesion Size by Visit|The total wet AMD lesion size was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in wet AMD lesion size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 84|Extended PPS-A4 as observed|||mm^2||Standard Deviation|Mean
1317857|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment – Foveal Involvement (PEDfi) Thickness by Visit|The thickness of pigment epithelial detachment involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of pigment epithelial detachment involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing Data Imputed Using LOCF.|||μm||Standard Deviation|Mean
1317858|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit|The thickness of subretinal fluid involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of subretinal fluid involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing Data Imputed Using LOCF.|||μm||Standard Deviation|Mean
1317859|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Lesion Thickness by Visit|The thickness of the neovascular lesion was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of the neovascular lesion may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing data imputed using LOCF.|||μm||Standard Deviation|Mean
1317886|NCT02354235|Secondary|Change From Baseline in 2-hour PPG|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 24.|Baseline, 24 Weeks|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1317860|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit|The thickness of the neuro-retina, at the level of the central subfield, was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing data imputed using LOCF.|||μm||Standard Deviation|Mean
1317861|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site|Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity was conducted in each eye individually using ETDRS charts and reported in number of letters read correctly. An increase (gain) in letters read from the baseline assessment indicates improvement. Only one eye (study eye) contributed to the analysis.|Day -1, Day 14, Day 28, Day 56, Day 84|Extended PPS-A4. Missing Data Imputed Using LOCF.|||letters||Standard Error|Least Squares Mean
1317862|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site|The thickness of the retina was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 14, Day 28, Day 56, Day 84|Extended PPS-A4. Missing data imputed using the Last Observation Carried Forward (LOCF) approach.|||μm||Standard Error|Least Squares Mean
1317863|NCT02355028|Secondary|Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56|The number of LUCENTIS® retreatment needs identified before or at the Day 28 and Day 56 visits (even if retreatment was applied at a later visit) for each subject was used in the analysis.|Day 28, Day 56|Extended PPS-A4|||Participants|||Count of Participants
1317864|NCT02355028|Secondary|Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84|The number of LUCENTIS retreatment needs identified before or at the Day 84 visit (even if retreatment was applied at a later visit) for each patient was used in the analysis|Up to Day 84|Extended PPS-A4|||participants|||Number
1317865|NCT02355028|Secondary|Time to First LUCENTIS® Retreatment Need Identification up to Day 84|The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS.|Day 14, Day 28, Day 56, Day 84|Extended PPS-A4 who required retreatment|||Participants|||Count of Participants
1317866|NCT02355028|Primary|Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84|For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.|Day 84|Extended PPS-A4|||Participants|||Count of Participants
1317867|NCT02354924|Secondary|Symptoms, Problems and Complaints and Incidence Rate|Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye|3 month||||eye|eye||Count of Units
1317868|NCT02354924|Secondary|Slit Lamp Findings|Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings|3 month||||eye|eye||Count of Units
1317869|NCT02354924|Primary|Visual Acuity|Visual acuity correctable to snellen 20/25 or better|3 months||||eye|eye||Count of Units
1317870|NCT02354833|Primary|Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP||At time of surgery, up to 2 hours||||mcg||Full Range|Median
1317871|NCT02354833|Primary|Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP||At time of surgery, up to 2 hours||||mg||Full Range|Median
1317872|NCT02354833|Secondary|Percentage of Participants Experiencing Both Nausea and Emesis||At time of surgery, up to 2 hours||||percentage of participants||95% Confidence Interval|Number
1317873|NCT02354833|Primary|Number of Rescue Boluses to Maintain SBP|Number of rescue boluses to maintain the SBP within 100-120% of baseline|At time of surgery, up to 2 hours||||rescue boluses|||Number
1317874|NCT02354599|Secondary|Number of Participants With Positive Response for Anti MT203 Antibody||Baseline, Hour 168, 336, Day 42, 84|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
1317875|NCT02354599|Secondary|Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration||Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84|The pharmacodynamic analysis set was defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacodynamic data.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
1317876|NCT02354599|Secondary|Terminal Elimination Half-Life (T1/2) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||day||Full Range|Median
1317877|NCT02354599|Secondary|Maximum Observed Serum Concentrations (Cmax) of MT203||Predose and at multiple time points (up to Day 84) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1317878|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||ng*day/mL||Standard Deviation|Mean
1317879|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Mean
1317887|NCT02354235|Secondary|Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose(PPG)|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 24.|Baseline, 24 Weeks|Full analysis set|||hour*mg/dL||Standard Error|Least Squares Mean
1317888|NCT02354235|Secondary|Change From Baseline in Body Weight|The change from Baseline in Body Weight collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||percentage of Body Weight||Standard Error|Least Squares Mean
1317889|NCT02354235|Secondary|Change From Baseline in Fasting Plasma Glucose(FPG)|The change from Baseline in Fasting Plasma Glucose collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||mg/dL||Standard Error|Least Squares Mean
1317890|NCT02354235|Primary|Change From Baseline in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||percentage of HbA1c||Standard Error|Least Squares Mean
1317891|NCT02354222|Secondary|Change From Baseline in 2-hour PPG|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 24.|Baseline, 24 Weeks|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1317892|NCT02354222|Secondary|Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose(PPG)|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 24.|Baseline, 24 Weeks|Full analysis set|||hour*mg/dL||Standard Error|Least Squares Mean
1317893|NCT02354222|Secondary|Change From Baseline in Body Weight|The change from Baseline in Body Weight collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||percentage of Body Weight||Standard Error|Least Squares Mean
1317894|NCT02354222|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in Fasting Plasma Glucose collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||mg/dL||Standard Error|Least Squares Mean
1317895|NCT02354222|Primary|Change From Baseline in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||percentage of HbA1c||Standard Error|Least Squares Mean
1317896|NCT02353871|Secondary|The Time to Onset of Treatment Response Based on the Subject’s Diary Card.|Median time to onset of treatment response: subjects asked to record their assessment of study treatment response in a diary card on Days 1 to 7. They responded 'yes' or 'no' to the following question: 'since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?'|Day 1 to 7|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. One subject from the placebo group was excluded from the analysis due to missing data.|||Days||95% Confidence Interval|Median
1317897|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject’s Level of Satisfaction With the Appearance of Their Glabellar Lines.|"Adjusted proportion of responders at each post-treatment visit (measured by the subject's level of satisfaction with the appearance of their glabellar lines).~4-point categorical scale: Grade 0 - very satisfied; Grade 1 - satisfied; Grade 2 - dissatisfied; Grade 3 - very dissatisfied.~A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
1317898|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.|"SSA~4-point photographic scale: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles – 3.~A responder at maximum frown was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate wrinkles (Grade 2) or severe wrinkles (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
1317899|NCT02353871|Secondary|The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~Adjusted proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at each post-treatment visit compared with Baseline.~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
1317914|NCT02353299|Secondary|Number of Participants With Adverse Events|Adverse events were defined by any negative event experienced by a participant during the study (assessed in the morning prior to participants leaving the lab) and included the washout period following each treatment.|throughout the study until the final study visit, up to 6 weeks||||Participants|||Number
1317959|NCT02350881|Primary|Pain at Pressure of MTP1|Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
1319129|NCT02320838|Secondary|Thermal Pain Threshold Post-treatment 20 Min.|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|at 20 min. post-treatment||||ºC||Standard Deviation|Mean
1317900|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at rest was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at rest at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit.; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
1317901|NCT02353871|Secondary|The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). Subjects who were not responders at Day 29 were excluded from the analysis.~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 57, 85, 113, 148 and 183|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
1317902|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
1317903|NCT02353871|Primary|The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown on Day 29 and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 29|Modified intent-to-treat (mITT) population included all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. Subjects who did not have available data at Day 29 were excluded from the analysis.|||Adjusted percentage of responders||95% Confidence Interval|Number
1317904|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 48 hours||||MUEs||Standard Deviation|Mean
1317905|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 6 participants who received rescue medication|Through 24 hours||||MUEs||Standard Deviation|Mean
1317906|NCT02353754|Primary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 72 hours postdose||||MUEs||Standard Deviation|Mean
1317907|NCT02353572|Primary|Maximally Tolerable Dose (MTD) of Both Melphalan and Bortezomib as Combination|MTD is defined as one dose below that which 33% of patients within cohort experienced dose limiting toxicity. Unacceptable toxicity is defined as intractable veno-occlusive disorder, new onset of renal failure requiring dialysis, acute heart failure of New York Heart Association class III/IV, or interstitial pneumonia requiring ventilator management for longer than 3 days or grade 4 neuropathy. A 100-day mortality/toxicity rate of 3% or more is considered unacceptable. Will consider as evidence an observed 100-day mortality/toxicity rate whose lower one-sided 90% confidence bound exceeds 3%.|100 days|The study was terminated, study endpoints were not reached.||||||
1317908|NCT02353468|Primary|Event Free Survival Rates by Land-mark Analysis|A Kaplan-Meier curve would have been used to describe the distribution.|up to 5 years|The study was terminated, study endpoints were not reached.||||||
1317909|NCT02353442|Secondary|Pain and Function at 4weeks (Pre and Post Treatment)|For these measures, the SPADI (Shoulder Pain and Disabilities Index) questionnaire was used, pre and post treatment. The is a self-assessment questionnaire with 5 questions about pain and 8 about functional activities. The final score (0-100) of the questionnaire is provided in percentage and a maximum score of 100 implies the worst possible condition.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||scores on a scale||Standard Deviation|Mean
1317910|NCT02353442|Secondary|Pressure Pain Threshold at 4weeks (Pre and Post Treatment).|It was measured by a digital algometer in kPa pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||kPa||Standard Deviation|Mean
1317911|NCT02353442|Secondary|Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).|The strength was evaluated with digital dynamometer in Newton pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||Newton||Standard Deviation|Mean
1317912|NCT02353442|Primary|Humeral Translations at 4weeks (Pre and Post Treatment).|It was assessed in millimeters with 3D system pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||Millimeters||Standard Error|Mean
1317913|NCT02353442|Primary|Scapular Kinematics at 4weeks (Pre and Post Treatment)|It was assessed in degrees with 3D system pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||degrees||Standard Error|Mean
1319130|NCT02320838|Secondary|Baseline Thermal Pain Threshold|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|Baseline at 0 min.||||ºC||Standard Deviation|Mean
1317915|NCT02353299|Secondary|Delayed Free Recall Task|"Delayed Free Recall Task was performed 15 minutes after final awakening the morning~Free Recall is a basic paradigm in the psychological study of memory. In this paradigm, participants were presented with a total of 16 words serially. They were informed prior to the task that memory for the presented words would be tested later in the session. Participants were asked to recall as many words as they can 15 minutes after final awakening in the morning"|15 minutes after final awakening the morning||||Number of words||Standard Deviation|Mean
1317916|NCT02353299|Secondary|Immediate Free Recall Task|"Immediate Free Recall will be performed at T-max for silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Free Recall is a basic paradigm in the psychological study of memory. In this paradigm, participants were presented with a total of 16 words serially. They were informed prior to the task that memory for the presented words would be tested later in the session."|directly after the encoding task||||Number of words||Standard Deviation|Mean
1317917|NCT02353299|Secondary|Berg Balance Test|"Berg Balance will be performed at T-max for silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Fall risk as impacted by gait was measured using the Berg Balance Scale (BBS). The BBS is a widely used clinical test of static and dynamic balance abilities. Comprising of 14 simple balance-related tasks, ranging from standing up from a sitting position to standing on one foot, the BBS takes 15–20 minutes to complete. Each component task is scored on a Likert scale: 0 (unable to perform) to 4 (performed independently). The sum of component scores yields the final BBS score (0-20: high fall risk; 21–40: medium fall risk; 41–56: low fall risk)."|at either 1.5 or 4 hours post dose||||sum of component scores||Standard Deviation|Mean
1317918|NCT02353299|Secondary|Tandem Walk Duration Over Five Trials|"Tandem walk will be performed at T-max for Silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Fall risk as impacted by balance was measured using the Tandem Walk Test (TWT), which assesses balance via a method of walking in which the toes of the back foot must touch the heel of the front foot at each step; this elicits postural control by reducing the base of support compared to normal walking. Endpoint: mean completion duration over five trials."|at either 1.5 or 4 hours post dose||||Seconds||Standard Deviation|Mean
1317919|NCT02353299|Secondary|Tandem Walk Step-Offs|"Tandem walk will be performed at T-max for Silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Fall risk as impacted by balance was measured using the Tandem Walk Test (TWT), which assesses balance via a method of walking in which the toes of the back foot must touch the heel of the front foot at each step; this elicits postural control by reducing the base of support compared to normal walking. Endpoints were the number of step-offs from the beam."|at either 1.5 or 4 hours post dose||||number of step offs||Standard Deviation|Mean
1317920|NCT02353299|Primary|Auditory Arousal Threshold (AAT) at T-max|"AAT will performed at T-max for Silenor and matching placebo at 4 hours post dose. Assessments performed at t max for zolpidem and placebo at 1.5 hours post dose.~An acoustic stimulus (1000 Hz tone) was presented through audiometric earphones (E-A-RTone 3A Insert Earphones). Tones began at 30 dB and increased by 5 dB until the participant woke up or the maximum dB-level (110 dB) was reached."|at either 1.5 or 4 hours post dose||||Decibels (dB)||Standard Deviation|Mean
1317921|NCT02352779|Primary|Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value|"BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).~MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue)."|Baseline to 6 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1317922|NCT02352363|Secondary|Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).|To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.|Month 12 reported||||mL/min/mmHg||Standard Deviation|Mean
1317923|NCT02352363|Primary|Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.|To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).|Month 12 reported||||Ratio (%)||Standard Deviation|Mean
1317924|NCT02352363|Primary|Pulmonary Safety Assessed by Forced Vital Capacity [FVC].|To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).|Month 12 reported||||Liters||Standard Deviation|Mean
1317925|NCT02352363|Primary|Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]|To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second [FEV1], over a 12 month period.|Month 12 reported||||Liters||Standard Deviation|Mean
1317926|NCT02352298|Primary|Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)|Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations <75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.|6 seconds||||percentage of participants|||Number
1317927|NCT02351960|Secondary|Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus|Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference.|Week 8|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.|||percentage of participants|||Number
1317928|NCT02351960|Secondary|Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms|The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP).|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here, 'n' is the number of participants who were analyzed for GERD assessments at specified time points.|||participants|||Number
1317929|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of nights||Full Range|Median
1317930|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of nights||Full Range|Median
1317931|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of nights||Full Range|Median
1317932|NCT02351960|Secondary|Percentage of 24-hour Acid Regurgitation-free Days|Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
1317933|NCT02351960|Secondary|Percentage of 24-hour Heartburn-free Days|Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
1317934|NCT02351960|Primary|Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants|EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated.|Up to Week 8|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
1317935|NCT02351960|Primary|Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants|NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.|Up to Week 4|Full analysis set (FAS) included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.|||percentage of days||Full Range|Median
1317936|NCT02351934|Secondary|Number of Participants With Hypokalemia|Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.|Up to 7 days|Intention to treat analysis|||Participants|||Count of Participants
1317937|NCT02351934|Secondary|Number of Participants With Acute Kidney Injury|Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event.|Up to 7 days|Intention to treat analysis|||Participants|||Count of Participants
1317938|NCT02351934|Secondary|Time to Stool Output||Up to 4 days|Intention to treat analysis|||hours||Inter-Quartile Range|Median
1317939|NCT02351934|Secondary|Number of Participants Requiring Nasogastric Tube Placement||Up to 7 days|Intention to Treat Analysis|||Participants|||Count of Participants
1317940|NCT02351934|Secondary|Number of Participants Readmitted to Mayo Clinic Within 30-days||Within 30 days of release from hospital|Intention to treat analysis|||Participants|||Count of Participants
1317941|NCT02351934|Primary|Length of Hospital Stay|Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.|Up to 7 days|Intent to treat analysis|||hours||Inter-Quartile Range|Median
1317957|NCT02350881|Primary|Pain During Walking|"Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
1317958|NCT02350881|Primary|Walking Perimeter|"Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : improved, same, worsened."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
1317942|NCT02351817|Primary|Product Acceptance|"Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products.~There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate.~The result presented below shows how many subjects preferred Test A/Test B over own product"|7 days per test period|One subject did not answer the preference question.|||participants|||Number
1317943|NCT02351505|Secondary|Proportion of Patients Who go Off Treatment Due to Adverse Reactions or Even Those Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
1317944|NCT02351505|Secondary|Tolerability of the Regimen Assessed Through Number of Patients Who Required Dose Modifications and/or Dose Delays||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
1317945|NCT02351505|Secondary|Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0|The incidence of severe (grade 3+) adverse events or toxicities will be described.|Up to 4 years||||percentage of patients|||Number
1317946|NCT02351505|Secondary|Frequency of Adverse Events Defined as Adverse Events That Are Classified as Either Not Related, Possibly, Probably, or Definitely Related to Study Treatment as Per NCI CTCAE v4.0|Summarized by descriptive statistics for each of the disease cohorts. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, review all adverse event data that is graded as 3, 4, or 5 and classified as either “unrelated” or “unlikely to be related” to study treatment in the event of an actual relationship developing.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
1317947|NCT02351505|Secondary|Overall Survival|Kaplan-Meier curves will be used to estimate overall survival. Consider Cox proportional hazards models to explore a limited set of confounding factors.|Date of study registration to the date of event (i.e., death) or the date of last follow-up if no event has occurred at their last evaluation assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
1317948|NCT02351505|Secondary|Disease Control Rate (CR, PR, and Stable Disease)|Estimates will be accompanied by exact binomial confidence intervals.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
1317949|NCT02351505|Secondary|Objective Response Rate (Complete Response [CR] or Partial Response [PR]) by RECIST|The overall response rate will be calculated as the number of PRs and CRs divided by the total number of evaluable patients. Estimates will be accompanied by exact binomial confidence intervals as well.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
1317950|NCT02351505|Primary|Progression Free Survival|Estimated by the method of Kaplan and Meier for each cohort. Appropriate one-sided 90% confidence boundary will also be calculated for the final test Kaplan–Meyer test statistic at 12 weeks.|Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
1317951|NCT02351037|Secondary|Clinical Benefit Rate - as Defined as the Proportion of Subjects Who Achieve CR, CRi, Morphologic Leukemia-free State, or Partial Remission (PR)|To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).|When the last subject enrolled completes approximately 12 months of treatment|||||||
1317952|NCT02351037|Secondary|Relapse-free Survival (RFS), Event-free Survival (EFS) and Overall Survival (OS)|To evaluate clinical efficacy by assessing relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).|When the last subject enrolled completes approximately 12 months of treatment|||||||
1317953|NCT02351037|Primary|Safety and Tolerability of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine|Number of Participants with Adverse Events and number of patients with lab abnormalities.The safety profile of ibrutinib was evaluated based on the incidence of adverse events (AEs) as well as clinically significant laboratory abnormalities and vital signs, and other malignancies. The safety evaluations performed in this study were standard and/or were required based on the safety data available from other clinical and preclinical settings.|Up to 30 days following the last dose of study drug.|||||||
1317954|NCT02351037|Primary|Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines|Dohner’s 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/µL]) or thrombocytopenia (<100 x 109/L [100 000/µL]) ; Morphologic leukemia-free state, Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts > 5%; or reappearance of blasts in the blood; or development of extramedullary disease.|When the last subject enrolled completes approximately 12 months of treatment.||||Participants|||Count of Participants
1317955|NCT02350881|Secondary|Survival of the Implant.|The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||percentage of implants|Participants||Number
1317956|NCT02350881|Primary|Pain at Rest|"Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
1329612|NCT02107014|Primary|Change in IL-12p40 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1317960|NCT02350881|Secondary|Bone Resorption|Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort|||percentage of implants|Participants||Number
1317961|NCT02350881|Secondary|Osteolysis|Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort|||percentage of implants|Participants||Number
1317962|NCT02350881|Primary|Pain at Passive Motion of MTP1|Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
1317963|NCT02350881|Primary|AOFAS Hallux-MTP-IP - PAIN Score|Pain is a sub-score of the AOFAS Hallux-MTP-IP score and is measured on a scale of 40 points - the higher value represents a minimal pain.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||units on a scale|Participants|Standard Deviation|Mean
1317964|NCT02350881|Primary|AOFAS Hallux-MTP-IP Score - Overall|"AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points. The AOFAS total score is then ranging from 0 to 100 points. A result over 80 points is considered good, below 20 points as bad."|mean 6.9 years follow-up (range 5.2 - 9.5)|number of implants analyzed (70 implants in 64 patients)|||units on a scale|Participants|Standard Deviation|Mean
1317965|NCT02350777|Primary|Peripheral Blood Counts Recovery (Response Will be Defined by Stable Blood Counts (ANC>1000, Hb>8 With Absolute Reticulocyte Count>20x10^9/L ,and Plt>50,000) Without Support of Blood Product Transfusions and/or Growth Factors.|will be documented by CBC checks every 2 weeks. Response will be defined by stable blood counts (ANC>1000, Hb>8 with absolute reticulocyte count>20x10^9/L ,and Plt>50,000) without support of blood product transfusions and/or growth factors.|1 year|No data were collected||||||
1317966|NCT02350569|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28||Days 1, 3, 5, 7, 14, 21, and 28|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1317967|NCT02350569|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~End of treatment virologic failure:~Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement."|Up to Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug|||percentage of participants|||Number
1317968|NCT02350569|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1317969|NCT02350569|Primary|Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event||Up to 4 weeks|Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1317970|NCT02350569|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1317971|NCT02349711|Secondary|Regulatory T Cells (Tregs)|Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry|baseline and week 6|A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples. Some samples could not be accurately measured for this outcome, so those samples were excluded from analysis.|||percentage of CD4+ T lymphocytes||Standard Error|Least Squares Mean
1317972|NCT02349711|Secondary|Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire|Symptoms included in this score are constipation, hard stools, and feeling of incomplete evacuation reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire. Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.|weeks 0, 1, 2, 3, 4, 5, 6, 7|Since this outcome had more than two time points, and since all randomized participants provided some weeks of survey data, all participants were included in the analysis (even those that were lost to follow up). The number of values (and thus the number analyzed) by week is also shown.|||units on a scale||Standard Error|Mean
1317973|NCT02349711|Secondary|Serum Total Immunoglobulin E (IgE)|Serum total immunoglobulin E (IgE) was quantified via ELISA|baseline and week 6|A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples.|||ng/mL||Standard Error|Mean
1317974|NCT02349711|Primary|Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ|MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)|up to 8 weeks from date of randomization|"Because this was an intent-to-treat study, all data from all randomized participants was considered for analysis. No imputation was done, so missing values excluded a participant from the analysis. While data from a participant may be missing, they were considered to have completed the study if they completed all study visits."|||units on a scale||Standard Error|Least Squares Mean
1317975|NCT02349685|Secondary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.~The eradication rate was evaluated by per-protocol analysis (PP)"|6 weeks after completion of eradication||||participants|||Number
1317976|NCT02349685|Primary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.~The eradication rate was evaluated by intention to treat (ITT)"|6 weeks after completion of eradication||||participants|||Number
1317977|NCT02349646|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|3, 6 and 12-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||Participants|||Count of Participants
1317978|NCT02349646|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|Baseline, 3, 6 and 12-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
1317979|NCT02349542|Secondary|Plasma Bupivacaine Levels|Blood samples will be drawn and analyzed to establish levels of bupivacaine detectable in the blood. Blood samples will be drawn at baseline (prior to injection), upon injection, at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours post-injection and analyzed to determine levels of bupivacaine present.|Up to 72 hours following injection|Blood draws were collected at the pre-defined intervals unless the patient was discharged prior to the blood collection time. 6 patients were discharged prior to the 48 hour collection time. 5 additional patients were discharged prior to the 72 hour collection time.|||ug/ml||Standard Deviation|Mean
1317980|NCT02349542|Primary|Adverse Events|Number of Participants with Adverse Events|Up to 72 hours following injection||||participants|||Number
1317981|NCT02349451|Secondary|Change From Baseline in Psoriasis Target Lesion Score at Week 12|Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||units on a scale||95% Confidence Interval|Least Squares Mean
1317982|NCT02349451|Secondary|Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12|PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||units on a scale||95% Confidence Interval|Least Squares Mean
1317983|NCT02349451|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||units on a scale||95% Confidence Interval|Least Squares Mean
1317984|NCT02349451|Secondary|ACRn at Week 12|ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.|At Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF): missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||percentage improvement||95% Confidence Interval|Mean
1317985|NCT02349451|Secondary|ACR70 Response Rate at Week 12|Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
1317986|NCT02349451|Secondary|ACR50 Response Rate at Week 12|Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
1319131|NCT02320838|Secondary|Mechanical Pain Threshold Post-treatment 40 Min.|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.|at 40 min. post-treatment||||N||Standard Deviation|Mean
1317987|NCT02349451|Secondary|ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab|Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
1317988|NCT02349451|Primary|American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo|Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Non-responder imputation (NRI): missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
1317989|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.|||microns||Standard Deviation|Mean
1317990|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.|||microns||Standard Deviation|Mean
1317991|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.|||microns||Standard Deviation|Mean
1317992|NCT02349360|Secondary|Composite Measure of Blood Chemistry Profiles|Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.|13 weeks|Subjects completing intervention and final blood draw after 4 week washout period.|||events|||Number
1317993|NCT02349360|Primary|Number of Participants Reporting Adverse Events|The number of participants reporting Adverse Events was reported.|13 weeks|Subjects completing the probiotic and the placebo intervention.|||Participants|||Count of Participants
1317994|NCT02349295|Secondary|Percentage of Participants Achieving ACR 70||Week 52 and up to 3 years||2020-07-31|07/2020||||
1317995|NCT02349295|Secondary|Percentage of Participants Achieving ACR 50||Week 52 and up to 3 Years||2020-07-31|07/2020||||
1317996|NCT02349295|Secondary|Percentage of Participants Achieving ACR20||Week 52 and up to 3 Years||2020-07-31|07/2020||||
1317997|NCT02349295|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab|The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).|All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)|The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
1317998|NCT02349295|Secondary|Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab|The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.|All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)|The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.|||micograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1317999|NCT02349295|Secondary|Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)|Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.|Week 24|All randomized participants who received at least 1 dose of ixekizumab and had evaluable anti-ixekizumab antibody measurement.|||Participants|||Number
1318000|NCT02349295|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline MCS data.|||Units on a Scale||Standard Error|Least Squares Mean
1318046|NCT02348723|Secondary|Incidence of Minor Bleeding Events|"Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented.~These are based on adjudicated data (blinded evaluation)"|during and up to 2 months post-ablation|AS|||percentage of participants|||Number
1318001|NCT02349295|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline PCS data.|||Units on a Scale||Standard Error|Least Squares Mean
1318002|NCT02349295|Secondary|Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score|The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no fatigue” and 10 representing “as bad as you can imagine.” Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline fatigue NRS data.|||Units on a Scale||Standard Error|Least Squares Mean
1318003|NCT02349295|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score data.|||Units on a Scale||Standard Error|Least Squares Mean
1318004|NCT02349295|Secondary|Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)|The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline DAS28-CRP data.|||Units on a Scale||Standard Error|Least Squares Mean
1318005|NCT02349295|Secondary|Change From Baseline in C-Reactive Protein (CRP)|C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline CRP data.|||milligram per liter (mg/L)||Standard Error|Least Squares Mean
1318006|NCT02349295|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity VAS|The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline Physicians Global Assessment of Disease Activity VAS score.|||Units on a Scale||Standard Error|Least Squares Mean
1318007|NCT02349295|Secondary|Change From Baseline in Patients Global Assessment of Disease Activity VAS|The patient’s overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline Patients Global Assessment of Disease Activity VAS score.|||Units on a Scale||Standard Error|Least Squares Mean
1318008|NCT02349295|Secondary|Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline TJC and SJC data.|||Units on a Scale||Standard Error|Least Squares Mean
1318162|NCT02347072|Secondary|FEV1 AUC12-24|Normalized FEV1 AUC12-24|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318009|NCT02349295|Secondary|Change From Baseline in Swollen Joint Count (SJC)|SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline SJC data.|||Swollen Joint Count||Standard Error|Least Squares Mean
1318010|NCT02349295|Secondary|Change From Baseline in Tender Joint Count (TJC)|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline TJC data.|||Tender Joint Count||Standard Error|Least Squares Mean
1318011|NCT02349295|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS)|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."|Baseline, Week 12|All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score data.|||Units on a Scale||Standard Error|Least Squares Mean
1318012|NCT02349295|Secondary|Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)|"The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, 0” indicates good score here."|Week 24|All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score data. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
1318013|NCT02349295|Secondary|Percentage of Patients Achieving Minimal Disease Activity (MDA)|It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients’ disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
1318014|NCT02349295|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75|The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.|Week 12|All randomized participants with baseline psoriatic lesion(s) involving ≥3% body surface area (BSA). NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
1318015|NCT02349295|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)|ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
1318016|NCT02349295|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)|ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
1318017|NCT02349295|Secondary|Percentage of Participants Achieving ACR20|ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 12|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
1318106|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilograms (kg) divided by height in square meter (m^2).|Day 1, Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
1318018|NCT02349295|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.|Baseline, Week 24|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
1318019|NCT02349295|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)|ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).|Week 24|All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
1318020|NCT02349152|Secondary|Glycemic Variability|Coefficient of variation|From the start of induction till 24 hours postoperatively|||||||
1318021|NCT02349152|Secondary|Development of Chronic Pain|Telephonic call Numeric pain scale|1, 3, 6 and 12 months after discharge from the hospital|||||||
1318022|NCT02349152|Secondary|Wound Hyperalgesia|Von frey hair objective testing|48 hours postoperatively and at Postoperative day seven|||||||
1318023|NCT02349152|Secondary|Emergence From Anesthesia|Time to extubation after completion of surgery in the operating room and intensive care unit|Immediate postoperative period until 30 days post-operatively||||Hours||Full Range|Median
1318024|NCT02349152|Secondary|Postoperative Pain|Visual analog scale for pain assessment & Total analgesic requirement (Morphine, oxycodone and tylenol used as analgesics)|Every hour for 48 hours postoperative period|||||||
1318025|NCT02349152|Secondary|Society of Thoracic Surgery Patient Outcomes|Postoperative outcomes collected from the Society of Thoracic Surgery (STS) database|30 day outcomes|||||||
1318026|NCT02349152|Secondary|Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)|Adreno-corticotrophic hormone (ACTH), Growth Hormone (GH) and Glucagon (measured as pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples: 30 mins after start of bypass (CPB 30) and end of bypass (CPB END), post-bypass and ICU 8 hours postoperative period|Perioperative period (Intraoperatively and 8 hours postoperatively)||||pg/ml||Full Range|Median
1318027|NCT02349152|Secondary|Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)|Inflammatory mediator levels, Interleukin-1b (IL-1b), Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNFa) (all measured in pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples:30 min start of bypass (CPB-30) and end of bypass (CPB-END), postbypass, ICU 8 hours postoperative period|Perioperative period (Intraoperatively and 8 hours postoperatively)||||pg/ml||Full Range|Median
1318028|NCT02349152|Secondary|Stress Hormone Levels-Cortisol (µg/dl)|Serum cortisol levels (measured as µg/dl) taken at: Prebypass, cardiopulmonary bypass (2 samples: at start of bypass and end of bypass), postbypass, ICU 8 hours postoperative period|Perioperative period (Intraoperatively and 8 hours postoperatively)||||µg/dl||Full Range|Median
1318029|NCT02349152|Secondary|Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability|Blood pressure (systolic, diastolic and mean), Heart rate every 5 minutes from induction of anesthesia till systemic heparinization before cardiopulmonary bypass|induction of anesthesia till systemic heparinization before cardiopulmonary bypass||2019-03-31|03/2019||||
1318030|NCT02349152|Secondary|Total Postoperative Regular Insulin|Total units of regular insulin required post-operatively|From ICU Admission (After Surgery) Until 24 hours postoperatively||||International Units||Full Range|Median
1318031|NCT02349152|Secondary|Postoperative Blood Glucose|Mean and peak blood glucose levels postoperatively|From ICU Admission (After Surgery) Until 24 hours postoperatively||||mg/dl||Full Range|Median
1318032|NCT02349152|Secondary|Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)|Blood glucose measured every hour|Intraoperative period; Induction to end of surgery||||Mg/dL||Full Range|Median
1318033|NCT02349152|Secondary|Number of Blood Glucose Values > 180 mg%|Blood glucose values that exceed 180 mg% will be counted|Intraoperative period, Induction to end of surgery||||number of glucose values >180mg%||Full Range|Median
1318034|NCT02349152|Secondary|Insulin Requirement|Average dose of insulin (Units/ml) calculated for each group in the intraoperative period|Intraoperative period; Induction to end of surgery||||Units/ml||Full Range|Mean
1318035|NCT02349152|Primary|Blood Glucose Values (More Than One ) > 180 mg%|"Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study.~(Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016)"|Intraoperative period||||Participants|||Count of Participants
1318047|NCT02348723|Secondary|Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA)|"Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.~Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.~Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.~These are based on adjudicated data (blinded evaluation).~Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presented"|during and up to 2 months post-ablation|AS|||percentage of participants|||Number
1318036|NCT02349061|Primary|Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24|SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician’s Global Assessment of Disease Activity (PGA). Composite response is defined as SRI-4 response in participants who do not meet treatment failure criteria. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well (0)-very poor (10).|Week 24|Full analysis set (FAS) included all participants who received at least one dose (partial or complete, intravenously [IV] or subcutaneously [SC]) of ustekinumab or placebo.|||Percentage of participants|||Number
1318037|NCT02349048|Secondary|Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR|The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported.|up to Week 30 for Arm A and Week 32 for Arm B|The ITT analysis set is defined as all enrolled participants who took at least 1 dose of SMV, SOF or DCV. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Percentage of Participants|||Number
1318038|NCT02349048|Secondary|Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR.|Up to Week 30 for Arm A and up to Week 32 for Arm B|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Participants|||Number
1318039|NCT02349048|Secondary|Number of Participants With Late Viral Relapse|Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable.|From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Participants|||Number
1318040|NCT02349048|Secondary|Number of Participants With Viral Relapse|Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during followup.|From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Participants|||Number
1318041|NCT02349048|Secondary|Percentage of Participants With On-Treatment Failure|Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been <LLOQ while on treatment.|Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Percentage of Participants|||Number
1318042|NCT02349048|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment|Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was <LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.|4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Percentage of Participants|||Number
1318043|NCT02349048|Secondary|Percentage of Participants With On-treatment Virologic Response|"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: <LLOQ undetectable, <LLOQ detectable, and <LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment."|Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV). Here 'n' signifies number of participants who were evaluable at each specified time point, for each arm, respectively.|||Percentage of Participants|||Number
1318044|NCT02349048|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.|12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Percentage of Participants|||Number
1318045|NCT02348723|Secondary|Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy|"Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented.~These are based on adjudicated data (blinded evaluation)"|during and up to 2 months post-ablation|AS|||percentage of participants|||Number
1318048|NCT02348723|Primary|Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH)|"Major bleeds were defined according to the ISTH definition of a major bleed, as follows~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or~Bleeding associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or~Fatal bleed~These are based on adjudicated data (blinded evaluation)~Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented."|during and up to 2 months post-ablation|The ablation set (AS) was the primary analysis set and included all patients in the treated set (TS) who started the ablation procedure|||percentage of participants||95% Confidence Interval|Number
1318049|NCT02348658|Secondary|Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.|Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
1318050|NCT02348658|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
1318051|NCT02348658|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
1318052|NCT02348658|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
1318053|NCT02348658|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
1318054|NCT02348658|Primary|Urinary Excretion Ratio of AML|Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||percentage of dose|||Number
1318055|NCT02348658|Primary|Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ|Urinary excretion ratio (percent [%] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||percentage of dose|||Number
1318056|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
1318057|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
1318058|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
1318059|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
1318060|NCT02348658|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML|AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
1318154|NCT02347085|Primary|FEV1 AUC0-24 on Day 29|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29|Day 29|Modified-Intent-to-Treat (MITT) Population|||Liters||95% Confidence Interval|Mean
1329613|NCT02107014|Primary|Change in IL-10 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1318061|NCT02348658|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1318062|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)||Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng/mL||Standard Deviation|Mean
1318063|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)||Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1318064|NCT02348359|Primary|Mean Change in Visual Acuity Score From Day -1 to Week52|The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.|Week 52|Analysis restricted to subjects who completed 52 weeks of treatment|||number of letters||Standard Deviation|Mean
1318065|NCT02347774|Secondary|Incidence Rate Per 1000 Person-years of Subjects With Major Adverse Cardiac Events (MACE)|"All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)~Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000."|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .|||incidence rate|||Number
1318066|NCT02347774|Secondary|Percentage of Subjects With Major Adverse Cardiac Events (MACE)|All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
1318067|NCT02347774|Secondary|Number of Subjects With Major Adverse Cardiac Events (MACE)|All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
1318068|NCT02347774|Secondary|Percentage of Subjects Who Discontinue Treatment Due to TEAE|A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
1318069|NCT02347774|Secondary|Number of Subjects Who Discontinue Treatment Due to TEAE|A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
1318070|NCT02347774|Secondary|Percentage of Subjects With Treatment Emergent Serious Adverse Events (SAE)|A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
1318071|NCT02347774|Secondary|Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)|A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
1318072|NCT02347774|Secondary|Percentage of Subjects With Treatment Emergent Adverse Events (TEAE)|A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
1318073|NCT02347774|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAE)|On-treatment A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
1318074|NCT02347774|Secondary|Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period|"All collected Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Week 0-12|"Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study One subject randomized in error to the placebo arm was never dosed .~medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed ."|||puffs (medication used)||Standard Error|Least Squares Mean
1318075|NCT02347774|Secondary|Change From Baseline in Health Status Measured by St. George’s Respiratory Questionnaire (SGRQ) Week 12/End of Study|"On-treatment Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .|||units on a scale||Standard Error|Least Squares Mean
1318076|NCT02347774|Secondary|Change From Baseline in Health Status Measured by St. George’s Respiratory Questionnaire (SGRQ) at Week 12/End of Study|"All collected Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .|||units on a scale||Standard Error|Least Squares Mean
1318077|NCT02347774|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC)Week 12|"On-treatment Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to. One subject randomized in error to the placebo arm was never dosed .|||liters||Standard Error|Least Squares Mean
1318078|NCT02347774|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12|"All collected Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to. One subject randomized in error to the placebo arm was never dosed .|||liters||Standard Error|Least Squares Mean
1318079|NCT02347774|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12|"On-treatment Spirometry was performed according to internationally accepted standards. Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1318080|NCT02347774|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|"All collected Spirometry was performed according to internationally accepted standards. Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .|||liters||Standard Error|Least Squares Mean
1318081|NCT02347761|Secondary|Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)|ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)I ncidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||events per 100 person-years|||Number
1318082|NCT02347761|Secondary|Percent of Subjects Who Discontinue Treatment Due to TEAE|ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation|||percentage of participants|||Number
1318083|NCT02347761|Secondary|Number of Subjects Who Discontinue Treatment Due to TEAE|ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation|||participants|||Number
1318084|NCT02347761|Secondary|Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE)|ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication|||percentage of participants|||Number
1318085|NCT02347761|Secondary|Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)|ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication|||participants|||Number
1318086|NCT02347761|Secondary|Percent of Subjects With Treatment Emergent Adverse Events (TEAE)|ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
1318087|NCT02347761|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAE)|ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
1318088|NCT02347761|Secondary|Percentage of Subjects With Major Cardiac Events (MACE)|ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
1318089|NCT02347761|Secondary|Number of Subjects With Major Adverse Cardiac Events (MACE)|ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
1329614|NCT02107014|Primary|Change in IL-9 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1318090|NCT02347761|Secondary|Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period|"ALL COLLECTED Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Week 0-12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||puffs (medication used)||Standard Error|Least Squares Mean
1318091|NCT02347761|Secondary|Change From Baseline in Health Status Measured by St. George’s Respiratory Questionnaire (SGRQ) Week 12/End of Study|"ON TREATMENT Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||scores on a scale||Standard Error|Least Squares Mean
1318092|NCT02347761|Secondary|Change From Baseline in Health Status Measured by St. George’s Respiratory Questionnaire (SGRQ) at Week 12/End of Study|"ALL COLLECTED Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||scores on a scale||Standard Error|Least Squares Mean
1318093|NCT02347761|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12|ON TREATMENT Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Change from baseline in trough FVC was calculated as the trough FVC value at Week 12 minus the morning trough FVC at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1318094|NCT02347761|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12|"ALL COLLECTED Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random"|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1318095|NCT02347761|Secondary|Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population|ON TREATMENT The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time points. If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC.Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements, including serial spirometry, serial ECGs, serial vital sign measurements, as well as Holter monitoring at Visit 6.|||liters||Standard Error|Least Squares Mean
1318096|NCT02347761|Secondary|Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population|ALL COLLECTED The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time point(s). If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements|||liters||Standard Error|Least Squares Mean
1318097|NCT02347761|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12|ON TEATMENT-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1318098|NCT02347761|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) “ALL COLLECTED” and “ON TREATMENT” data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study.” for all endpoints|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1318099|NCT02347657|Secondary|Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolites (M1 VX-661 and M2-VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)|This outcome was not planned to be assessed in Placebo arm.|Pre-morning dose on Week 16|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1318100|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in Body Weight at Week 24||Day 1, Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||kg||95% Confidence Interval|Least Squares Mean
1318101|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in BMI Z-score at Week 24 in Participants Less Than (<) 20 Years Old at the Time of Screening)|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score).|Day 1, Week 24|Analysis population included all randomized participants who received at least 1 dose of study drug and were <20 years of age at the time of screening. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
1318102|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in Sweat Chloride Through Week 24|Sweat samples were collected using an approved collection device.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1318103|NCT02347657|Secondary|Number of Participants With at Least One Pulmonary Exacerbation Pulmonary Exacerbation Through Week 24|Pulmonary exacerbation was defined as a new event or change in antibiotic therapy for greater than or equal to 4 sinopulmonary signs/symptoms. Time to event data was not collected and instead, Number of Subjects with first event were collected and are reported. Time-to-first pulmonary exacerbation was planned to be estimated using Kaplan-Meier (KM) estimates. However, due to less than 50% of events, time-to-first event data was not estimated. Instead, number of participants with at least one pulmonary exacerbation event were collected and are reported.|Day 1 through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug.|||Participants|||Count of Participants
1318104|NCT02347657|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 28 was considered treatment-emergent.|Day 1 up to Week 28|Safety Set included all participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
1318105|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
1318107|NCT02347657|Secondary|Number of Pulmonary Exacerbations Per Year|Pulmonary exacerbation was defined as a new event or change in antibiotic therapy for greater than or equal to 4 sinopulmonary signs/symptoms. Pulmonary exacerbation events per year (48 weeks) were reported.|Day 1 through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug.|||pulmonary exacerbation events per year|||Number
1318108|NCT02347657|Secondary|Relative Change From Baseline (Day 1) in ppFEV1 Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||95% Confidence Interval|Least Squares Mean
1318109|NCT02347657|Primary|Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||Percentage of predicted FEV1||95% Confidence Interval|Least Squares Mean
1318110|NCT02347605|Primary|Withdrawal Symptom Severity Score Assessed Via Questionnaire|Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure.|approximately 15 minutes||||units on a scale||Standard Error|Least Squares Mean
1318111|NCT02347605|Primary|Craving Symptom Severity Score Assessed Via Questionnaire|Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure.|approximately 15 minutes||||units on a scale||Standard Error|Least Squares Mean
1318112|NCT02347488|Secondary|Potentially High Extubation Risk|Number of participants experiencing ETT movement >4cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)||||Participants|||Count of Participants
1318113|NCT02347488|Secondary|Clinically Significant Movement|Number of participants experiencing ETT movement >1cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)||||Participants|||Count of Participants
1318114|NCT02347488|Secondary|Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device|The patients were examined after surgery (both immediately after surgery and at the end of the recovery room period) to determine if the patient suffered any irritation or minor injury to the face and oral structures. The patients were asked to fill out a questionnaire after recovery with questions about their overall experience with specific relation to any irritation and/or minor trauma to their face, oral structures, throat, jaw, and temporomandibular joint.|Immediately after surgery and 1-3 days following surgery, before discharge.|29 patients returned the survey (one patient was aphasic post-op and could not compete the survey)|||Participants|||Count of Participants
1318115|NCT02347488|Primary|Change in ETT Position|The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the supine position was measured. The endotracheal tube, once secured with either tape or the Haider airway device, encountered an axial force to simulate the endotracheal tube being pulled from the mouth. The force increased over approximately 5 seconds until the target of 15 N was reached or until the principal investigator deemed that the force be aborted to prevent possible tracheal extubation. The change in position, measured in cm, was recorded.|5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).||||centimeters||Standard Deviation|Mean
1318116|NCT02347189|Other Pre-specified|Number of Subjects With Successful Procedure|"A successful implant is defined as follows:~Melody TPV PB1016 is fixated within the desired location~RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is < 35 mmHg~No more than trace/trivial pulmonary regurgitation by angiography~Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant."|At Time Of Procedure||2019-06-30|06/2019||||
1318117|NCT02347189|Other Pre-specified|Number of Subjects With Serious Adverse Events, Related Adverse Events and Free From Stent Fracture, Intervention on the TPV and Death|"Serious procedure-related adverse events~Serious device-related adverse events at 6 months, 1 year and 2 years post-implant~Freedom from stent fracture at 6 months, 1 year and 2 years post-implant~Freedom from catheter re-intervention on the Melody TPV PB1016 at 6 months, 1 year and 2 years post-implant~Freedom from RVOT conduit reoperation at 6 months, 1 year and 2 years post-implant~Freedom from death (all-cause, procedural, and device-related) at 6 months, 1 year and 2 years post-implant"|6 Months, 1 Year, 2 Years||2019-06-30|06/2019||||
1318118|NCT02347189|Secondary|Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years|"Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following:~Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler~Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography~Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation."|2 Years||2019-06-30|06/2019||||
1318119|NCT02347189|Secondary|Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year|"Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following:~Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler~Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography~Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation."|1 Year||2019-06-30|06/2019||||
1318155|NCT02347072|Secondary|Peak Change From Baseline in IC Morning|Peak Change From Baseline in IC Morning|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318156|NCT02347072|Secondary|Peak Change From Baseline in IC (Inspiratory Capacity) Evening|Peak Change From Baseline in IC Evening|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318120|NCT02347189|Primary|Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months|"Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following:~Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and~Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and~Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation"|6 Months|28 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 6 months.|||Participants|||Count of Participants
1318121|NCT02347176|Secondary|Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12|Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Baseline (Day 1) and Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||units on a scale||Standard Error|Mean
1318122|NCT02347176|Secondary|Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12|SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.|Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||Percentage of participants|||Number
1318123|NCT02347176|Secondary|Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12|The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Baseline (Day 1) and Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||units on a scale||Standard Error|Mean
1318124|NCT02347176|Secondary|Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12|EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.|Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||Percentage of participants|||Number
1318125|NCT02347176|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
1318126|NCT02347176|Secondary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
1318127|NCT02347176|Secondary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events|Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
1318128|NCT02347176|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
1318157|NCT02347072|Secondary|Morning Pre-Dose Trough FEV1 on Day 30|Morning Pre-Dose Trough FEV1 on Day 30|Day 30|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318158|NCT02347072|Secondary|Morning Pre-Dose Trough FEV1 on Day 29|Morning Pre-Dose Trough FEV1 on Day 29|Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318159|NCT02347072|Secondary|Peak Change From Baseline in FEV1 Morning|Peak Change From Baseline in FEV1 Morning|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318129|NCT02347176|Primary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12|The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.|Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||Percentage of participants|||Number
1318130|NCT02347176|Primary|Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12|EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Baseline (Day 1) and Week 12|"The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||units on a scale||Standard Error|Mean
1318131|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up|"SE to quit smoking was assessed using the following question:~As of today, how confident are you that you can…stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 6 months|Participants who provided responses to this item at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
1318132|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up|"SE to quit smoking was assessed using the following question:~As of today, how confident are you that you can…stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 2 months|Participants who provided responses to this item at baseline and 2 month follow-up.|||scores on a scale||Standard Deviation|Mean
1318133|NCT02347124|Other Pre-specified|Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up|"Motivation to see a dentist was assessed using the following question:~As of today, how motivated are you to…see a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 6 months|Participants who provided responses to this item at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
1318134|NCT02347124|Other Pre-specified|Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up|"Motivation to see a dentist was assessed using the following question:~As of today, how motivated are you to…see a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 2 months|Participants who provided responses to this item at baseline and 2 month follow-up.|||scores on a scale||Standard Deviation|Mean
1318135|NCT02347124|Other Pre-specified|Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up|"Motivation to stop smoking was assessed using the following question:~As of today, how motivated are you to…Stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 6 months|Participants providing responses to this item at baseline and 6-month follow-up|||scores on a scale||Standard Deviation|Mean
1318136|NCT02347124|Other Pre-specified|Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up|"Motivation to stop smoking was assessed using the following question:~As of today, how motivated are you to…Stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 2 months|Participants providing responses to this item at baseline and 2 month follow-up|||scores on a scale||Standard Deviation|Mean
1318160|NCT02347072|Secondary|Peak Change From Baseline in FEV1 Evening|Peak Change From Baseline in FEV1 Evening|Baseline and Day 29|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
1318161|NCT02347072|Secondary|FEV1 AUC0-12|Normalized FEV1 AUC0-12|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318137|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up|"SE to see a dentist was assessed using the following question:~As of today, how confident are you that you can…See a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 6 months|Participants who provided responses to this item at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
1318138|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up|"SE to see a dentist was assessed using the following question:~As of today, how confident are you that you can…See a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 2 months|Participants who provided responses to this item at baseline and 2 follow-up.|||scores on a scale||Standard Deviation|Mean
1318139|NCT02347124|Other Pre-specified|Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up|"Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:~Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.~Responses and scoring to the adapted NHIS scale:~Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5~Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.~The scores have a range of 7 (minimum) to 35 (maximum).~The study outcome is the change in this score between BL and 6 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge."|Baseline to 6 months|Participants providing data for this measure at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
1318140|NCT02347124|Other Pre-specified|Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up|"Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:~Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.~Responses and scoring to the adapted NHIS scale:~Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5~Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.~The scores have a range of 7 (minimum) to 35 (maximum).~The study outcome is the change in this score between BL and 2 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge."|Baseline to 2 months|Participants providing data for this measure at the baseline and 2 month follow-up.|||scores on a scale||Standard Deviation|Mean
1318141|NCT02347124|Secondary|7 Day Point Prevalent Smoking Abstinence (PPA)|Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.|6 months post-enrollment|Complete case analysis limited to survey respondents.|||Participants|||Count of Participants
1318142|NCT02347124|Secondary|7 Day Point Prevalent Smoking Abstinence (PPA)|Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.|2 months post-enrollment|Analysis limited to survey respondents (i.e., complete cases only).|||Participants|||Count of Participants
1318143|NCT02347124|Secondary|7 Day Point Prevalent Abstinence (PPA)|7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers|2 months post-enrollment|All participants with missing data imputed as smokers.|||Participants|||Count of Participants
1318144|NCT02347124|Primary|Professional Dental Care Utilization in Past 6 Months|self-reported utilization of professional dental care during study observation period|6 months post-enrollment|All participants with missing data imputed as not having seen a dentist.|||Participants|||Count of Participants
1318145|NCT02347124|Primary|7 Day Point Prevalent Abstinence (PPA)|7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.|6 month post-enrollment|All participants with missing data imputed as smokers.|||Participants|||Count of Participants
1318146|NCT02347085|Secondary|Peak Change From Baseline in IC Following the Morning Dose on Day 29|Peak Change from Baseline in IC following the morning dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
1318147|NCT02347085|Secondary|Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29|Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
1318148|NCT02347085|Secondary|Morning Pre-Dose Trough FEV1 on Day 30|Morning Pre-Dose Trough FEV1 on Day 30|Day 30|MITT Population|||Liters||95% Confidence Interval|Mean
1318149|NCT02347085|Secondary|Morning Pre-Dose Trough FEV1 on Day 29|Morning Pre-Dose Trough FEV on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
1318150|NCT02347085|Secondary|Peak Change From Baseline in FEV1 on Day 29|Peak Change From Baseline in FEV1 following the morning dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
1318151|NCT02347085|Secondary|Peak Change From Baseline in FEV1 on Day 29|Peak Change From Baseline in FEV1 following evening Dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
1318152|NCT02347085|Secondary|FEV1 AUC0-12 on Day 29|FEV1 AUC0-12 on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
1318153|NCT02347085|Secondary|FEV1 AUC12-24 on Day 29|FEV1 AUC12-24 on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
1318163|NCT02347072|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24|Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29|Subjects in the Modified Intent to Treat (MITT) Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
1318164|NCT02346877|Secondary|Beliefs About Medicines Questionnaire (BMQ)|BMQ consists of two five-item scales assessing patients’ beliefs about the necessity of Enbrel® for controlling their rheumatoid arthritis and their concerns about potential adverse consequences of taking Enbrel®. Using a five-point Likert scale, on each of necessity and concerns, the individual items within both scales are summed. The total scores for the Necessity and Concerns Scales range from 5 to 25. Higher scores indicate stronger beliefs.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.||||||
1318165|NCT02346877|Secondary|Adherence to Study Drug up to 52 Weeks|A participant’s adherence is determined as a medication possession ratio (MPR) of at least 80%. The MPR is the ratio of the total number of weeks’ supply, based on pharmacy data, of Enbrel® divided by either 52 weeks or duration on study if a physician stops prescribing Enbrel® due to an adverse drug reaction or lack of efficacy.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.||||||
1318166|NCT02346877|Primary|Persistence of Study Drug Measured at 52 Weeks|A participant is persistent if the date of the last prescription filled plus the number of weeks supply of the prescription is greater than or equal to 52 weeks from enrolment and the eDiary confirms Enbrel® from the prescription was injected. A participant is not persistent if the last prescription filled plus the number of weeks supply of the prescription is less than 52 weeks from enrolment and the eDiary confirms there was no injection of Enbrel®, or, a participant is not persistent if the participant has a gap in treatment of more than 4 consecutive weeks for no medical reason at any time in the 52 week study period.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.||||||
1318167|NCT02346721|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1318168|NCT02346721|Secondary|HCV RNA Change From Baseline||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1318169|NCT02346721|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1318170|NCT02346721|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1318171|NCT02346721|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1318172|NCT02346721|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS) included all enrolled participants who took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1318173|NCT02346643|Primary|Pain Intensity in Overall Pain|"Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline~The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain)."|Post treatment at 3, 6 and 12 months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
1318174|NCT02346643|Primary|Pain Intensity in Primary Region of Pain|"Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline.~The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain)."|Post treatment at 3, 6 and 12 months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
1318175|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 48|The Week 16 Randomized Set (WK16RS) consisted of all subjects who achieved a PASI75 response at Week 16 and were re-randomized into the double-blind, placebo-controlled Maintenance Treatment Period.|||percentage of participants|||Number
1319132|NCT02320838|Secondary|Mechanical Pain Threshold Post-treatment 20 Min.|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|at 20 min. post-treatment||||N||Standard Deviation|Mean
1318176|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 16|The Randomized Set (RS) consisted of all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318177|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Physician’s Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 16|The Randomized Set (RS) consisted of all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318178|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 16|The Randomized Set (RS) consisted of all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318179|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 12|The Randomized Set (RS) consisted of all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318180|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Physician’s Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 12|The Randomized Set (RS) consisted of all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318181|NCT02346240|Primary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 12|The Randomized Set (RS) consisted of all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318182|NCT02345772|Secondary|QTA (Quantitative Texture Analysis)|QTA (Quantitative Texture Analysis): will be obtained from baseline mammogram and the correlation with clinical outcome after neoadjuvant therapy will be performed.|One year|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1318183|NCT02345772|Secondary|Partial Pathological Response Rate|Partial pathological response rate at the time of surgery and biomarker changes in breast cancer (biopsy vs residual tumor) before and after neoadjuvant chemotherapy Note: pPR, defined as residual invasive disease of 1cm, ypT1a-b.|One Year|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1318371|NCT02341859|Secondary|Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours||||participants|||Number
1318184|NCT02345772|Primary|Pathological Complete Remission Rate|To determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive breast cancer patients undergoing neoadjuvant chemoimmunotherapy (docetaxel, trastuzumab, pertuzumab) concurrently with neoadjuvant hormonal therapy with fulvestrant. Note: pCR, defined as the absence of invasive neoplastic cells of the primary tumor in the breast, remaining in-situ lesions are allowed, ypT0-is;|one year|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1318185|NCT02345720|Primary|Corneal Staining|The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.|30 Days Post Wear|The analysis population consists of all subjects that were dispensed a study lens.|||percentage of upper corneal quadrant||Standard Deviation|Mean
1318186|NCT02345720|Primary|Limbal Staining|Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.|30 Days Post Wear|The analysis population consist of all subjects that were dispensed a study lens.|||percentage of limbal area||Standard Deviation|Mean
1318187|NCT02345720|Primary|Upper Eye Lid Margin Staining|Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.|30 days Post wear|The analysis population consists of all subjects that were dispensed a study lens.|||mm^2||Standard Deviation|Mean
1318188|NCT02345642|Primary|Peak Venous Velocity|Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded.|Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied||||cm/s||Full Range|Mean
1318189|NCT02345460|Secondary|Number of Participants Experiencing Perioperative (30-day) Mortality|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 30 days|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
1318190|NCT02345460|Secondary|Number of Participants Achieving R0 Resection|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
1318191|NCT02345460|Secondary|Number of Participants Achieving Major Pathologic Response|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
1318192|NCT02345460|Secondary|Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
1318193|NCT02345460|Secondary|Incidence of Toxicities Greater Than Grade 2, Using the Common Terminology Criteria for Adverse Events Version 4.0|Toxicity evaluation will be enumeration of all major toxicities, with proportions calculated for each.|Up to 30 days after end of treatment or to the day prior to surgery|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
1318194|NCT02345460|Secondary|Overall Survival|Time from enrollment to death from any cause. Will be estimated with Kaplan Meier curves.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed.||||||
1318195|NCT02345460|Secondary|Progression-free Survival|Time from enrollment to the earlier of death or disease progression. Will be estimated with Kaplan Meier curves.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
1318196|NCT02345460|Primary|Number of Patients Undergoing Surgical Resection After Receiving at Least 4 of the 6 Courses of Preoperative Chemotherapy|Proportion will be estimated using a binomial test.|Up to 12 weeks|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
1318197|NCT02345369|Secondary|Harris Hip Score|Subjective outcome scores (modified Harris hip score) will be collected at 3 and 6 months after surgery.|6 months|no outcomes to report||||||
1318198|NCT02345369|Secondary|Time to Radiographic Union|Time to radiographic union and any occurrence of hardware failure, nonunion and malunion will be noted|6 months|no outcomes to report||||||
1318199|NCT02345369|Primary|Femoral Neck Shortening|Femoral neck shortening will be measured radiographically with femoral neck offset and the femoral neck shaft angle to be measured radiographically based on standardized computerized measurements based off of PACs images. TraumaCad software (Voyanthealth, Westchester, Il) will be utilized to obtain standardized measurements.|6 months|no outcomes to report||||||
1318200|NCT02345330|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|From the start of study treatment until death|Due to early termination of the study overall survival data was not collected and reported.||||||
1318201|NCT02345330|Secondary|Median Time to Progression (TTP)|TTP is defined as the number of days between the treatment initiation date (Study Day 1) and the earliest date of documented disease progression as defined by RECIST 1.1 or death that is not associated with prior disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study TTP data was not collected and reported.||||||
1318290|NCT02344342|Secondary|Minnesota Living With Heart Failure Questionnaire|It provides a total score (range 0–105, where 0 is best quality of life up to 105 as worst Health Related Quality of Life),|180 day follow up|2 patients completed the study, whose answers were not coded into the analysis for the questionnaire, therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.|||units on a scale||Full Range|Mean
1318202|NCT02345330|Secondary|Median Progression Free Survival (PFS)|Progression free survival (PFS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the first date of either disease progression at either local or any distant sites, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients were censored at their date of last assessment, if they were alive and without evidence of disease progression.|From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study PFS data was not collected and reported.||||||
1318203|NCT02345330|Secondary|Regression Rate of Treated and Untreated Lesions|The treated (injected, electroporated) lesion regression rate is defined as the percentage of patients who had at least one treated lesion that decreased in longest dimension by ≥ 30%. The untreated (non-injected, non-electroporated) lesion regression rate is defined as the percentage of patients who had at least one untreated lesion that decreased in longest dimension by ≥ 30%.|Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study regression rate data was not collected and reported.||||||
1318204|NCT02345330|Secondary|Best Overall Response Rate (BORR) by Immune-related Response Criteria (irRC)|BORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using irRC criteria. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥50% decrease in the product of the diameters from baseline.|Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study BORR by irRC data was not collected and reported.||||||
1318205|NCT02345330|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.|From first study treatment to 30 days after the last study treatment (up to 14.5 months)|All enrolled participants.|||Participants|||Count of Participants
1318206|NCT02345330|Primary|Best Overall Response Rate (BORR) by RECIST v1.1|BORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study BORR by RECIST v1.1 data was not collected and reported.||||||
1318207|NCT02345252|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 96|Spine BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 96|||||||
1318208|NCT02345252|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48|Spine BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 48|Participants in the spine DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.|||percentage change||Standard Deviation|Mean
1318209|NCT02345252|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 96|Hip BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 96|||||||
1318210|NCT02345252|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 48|Participants in the Hip DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.|||percentage change||Standard Deviation|Mean
1318211|NCT02345252|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline and Week 96|||||||
1318212|NCT02345252|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline and Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/uL||Standard Deviation|Mean
1318213|NCT02345252|Secondary|Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm||Week 96|||||||
1318214|NCT02345252|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm||Week 96|||||||
1318215|NCT02345252|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm||Week 48|Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on FTC/RPV/TDF prior to screening visit.|||percentage of participants|||Number
1318216|NCT02345252|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on FTC/RPV/TDF prior to screening visit|||percentage of participants|||Number
1318217|NCT02345226|Secondary|Change From Baseline in HIV Symptoms Index Score at Week 96|The HIV symptom index score will be determined using a patient reported outcome questionnaire.|Baseline and Week 96|||||||
1318218|NCT02345226|Secondary|Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48|The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don’t have this symptom; 1 = It doesn’t bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.|Baseline and Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1318219|NCT02345226|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 96|Spine BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 96|||||||
1318220|NCT02345226|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48|Spine BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 48|Participants in the Spine DXA Analysis Set (all randomized participants, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed.|||percentage change||Standard Deviation|Mean
1318221|NCT02345226|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 96|Hip BMD will be assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 96|||||||
1318222|NCT02345226|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline and Week 48|Participants in the Hip DXA Analysis Set (all randomized participants received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.|||percentage change||Standard Deviation|Mean
1318223|NCT02345226|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline and Week 96|||||||
1318224|NCT02345226|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline and Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/uL||Standard Deviation|Mean
1318225|NCT02345226|Secondary|Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm||Week 96|||||||
1318226|NCT02345226|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm||Week 96|||||||
1318227|NCT02345226|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm||Week 48|Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on EFV/FTC/TDF FDC prior to the screening visit|||percentage of participants|||Number
1318228|NCT02345226|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all participants who (1) were randomized into the study, (2) received at least 1 dose of study drug, and (3) were on EFV/FTC/TDF FDC prior to the screening visit|||percentage of participants|||Number
1318229|NCT02345161|Secondary|Number of Participants With at Least One On-treatment Bone Fracture Incident in the Extension Part of the Study|To evaluate the potential for bone systemic corticosteroid effects, the incidence of bone fractures was assessed. It was categorized as an adverse event of special interest.|Up to Week 52|Extension Population|||Participants|||Number
1318230|NCT02345161|Secondary|Number of Participants With at Least One On-treatment Bone Fracture Incident in the Treatment Period|To evaluate the potential for bone systemic corticosteroid effects, the incidence of bone fractures was assessed. It was categorized as an adverse event of special interest.|Up to Week 24|ITT Population|||Participants|||Number
1318231|NCT02345161|Secondary|Number of Participants Reporting an AESI of Oropharyngeal Origin in the Extension Part of the Study|Oropharyngeal examinations for clinical evidence of infection (e.g., Candida albicans) were performed at each clinic visit. All suspected cases of candidiasis were reported as AEs. The number of participants with oral candidiasis, candida infection, oral fungal infection, and oropharyngeal candidiasis were reported.|Up to Week 52|Extension Population|||Participants|||Number
1318232|NCT02345161|Secondary|Number of Participants Reporting an Adverse Event of Special Interest (AESI) of Oropharyngeal Origin in the Treatment Period|Oropharyngeal examinations for clinical evidence of infection (e.g., Candida albicans) were performed at each clinic visit. All suspected cases of candidiasis were reported as AEs. The number of participants with oral candidiasis, Candida infection, oral fungal infection, and oropharyngeal candidiasis were reported.|Up to Week 24|ITT Population|||Participants|||Number
1318233|NCT02345161|Secondary|Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52|Blood samples were collected for the measurement of bilirubin, creatinine, and urate at Baseline, Week 12, Week 24, and Week 52 of the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat).|Baseline and Week 52|Extension Population|||Micromoles per liter||Standard Deviation|Mean
1318234|NCT02345161|Secondary|Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24|Blood samples were collected for the measurement of bilirubin, creatinine, and urate at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Micromoles per liter||Standard Deviation|Mean
1318320|NCT02343081|Other Pre-specified|Kel|Rate at which Temozolomide is removed from the body.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4||||1/h||Standard Deviation|Mean
1318235|NCT02345161|Secondary|Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52|Blood samples were collected for the measurement of Glucose, calcium, CO2, chloride, magnesium, phophate, potassium, sodium, and urea at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||Mmol/L||Standard Deviation|Mean
1318236|NCT02345161|Secondary|Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24|Blood samples were collected for the measurement of Glucose, calcium, CO2, chloride, phophate, potassium, sodium, and urea at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1318237|NCT02345161|Secondary|Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT at Baseline, Week 12, Week 24 and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||International units per liter (IU/L)||Standard Deviation|Mean
1318238|NCT02345161|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT at Baseline, Week 12 and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||International units per liter (IU/L)||Standard Deviation|Mean
1318239|NCT02345161|Secondary|Change From Baseline in Albumin and Protein at Week 52|Blood samples were collected for the measurement of albumin and protein at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||g/L||Standard Deviation|Mean
1318240|NCT02345161|Secondary|Change From Baseline in Albumin and Protein at Week 24|Blood samples were collected for the measurement of albumin and protein at Baseline, Week 12 and Week 24. Change from Baseline (BL) was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). The maximum post BL values have been presented. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||g/L||Standard Deviation|Mean
1318241|NCT02345161|Secondary|Change From Baseline in Hematocrit at Week 52|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as Most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||Fraction of 1||Standard Deviation|Mean
1318242|NCT02345161|Secondary|Change From Baseline in Hematocrit at Week 24|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Fraction of 1||Standard Deviation|Mean
1318243|NCT02345161|Secondary|Change From Baseline in Hemoglobin at Week 52|Blood samples were collected for the measurement of hemoglobin at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||g/L||Standard Deviation|Mean
1318244|NCT02345161|Secondary|Change From Baseline in Hemoglobin at Week 24|Blood samples were collected for the measurement of hemoglobin at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Grams per liter (g/L)||Standard Deviation|Mean
1329615|NCT02107014|Primary|Change in IL-8 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1318245|NCT02345161|Secondary|Change From Baseline in Erythrocytes at Week 52|Hematology laboratory assessments included erythrocytes and was measured at Baseline, Week 12 and Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 52. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||10^12 cells/L||Standard Deviation|Mean
1318246|NCT02345161|Secondary|Change From Baseline in Erythrocytes at Week 24|Hematology laboratory assessments included erythrocytes and was measured at Baseline, Week 12 and Week 24. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 24. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||10^12 cells/L||Standard Deviation|Mean
1318247|NCT02345161|Secondary|Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52|Hematology laboratory assessments included Basophils, eosinophils, lymphocytes, monocytes,neutrophils, total neutrophil, leukocytes, and platelets; parameters were measured at Baseline (BL), Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 52. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||10^9 cells/L||Standard Deviation|Mean
1318248|NCT02345161|Secondary|Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24|Hematology laboratory assessments included basophils, eosinophils, lymphocytes, monocytes, neutrophils, total neutrophil, leukocytes, and platelets; parameters were measured at Baseline (BL), Week 12 and Week 24. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 24. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a repeat test). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||10^9 cells/Liter(L)||Standard Deviation|Mean
1318249|NCT02345161|Secondary|Change From Baseline in Pulse Rate at Week 52|Pulse rate was obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4, Week 24, and Week 52 or at the Study Treatment Discontinuation. Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline values for pulse rate at Week 52 were summarized and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization (generally Screening but could be a test repeat).|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Bpm||Standard Error|Least Squares Mean
1318250|NCT02345161|Secondary|Change From Baseline in Pulse Rate at Week 24|Pulse rate was obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4 and Week 24 or at the Study Treatment Discontinuation. Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline values for pulse rate at Week 24 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization (generally Screening but could be a test repeat).|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Bpm||Standard Error|Least Squares Mean
1318251|NCT02345161|Secondary|Number of Participants With Any Abnormal Holter Electrocardiogram (ECG) Finding at Week 24|The 24-hour holter measurements were obtained at Screening and 24 hours prior to Week 24 (Visits 1 and 6). The number of participants with clinically significant change (abnormal) were reported. Holter Monitoring Population: all participants in the ITT Population who had at least one holter monitoring evaluation.|Up to Week 24|Holter Monitoring Population; Only participants with analyzable data at the given time point were analyzed.|||Participants|||Number
1318252|NCT02345161|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 52|Vital signs were obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4, Week 24, and Week 52 or at the Study Treatment Discontinuation Visit. A single set of blood pressure (systolic and diastolic) measurements were taken after the participant had rested for 5 minutes in the sitting position. Change from Baseline values for systolic and diastolic BP (SBP and DBP) at Week 52 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization which records both systolic and diastolic BP (generally Screening but could be a test repeat).|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||mmHg||Standard Error|Least Squares Mean
1318253|NCT02345161|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 24|Vital signs were obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4 and Week 24 or at the Study Treatment Discontinuation Visit. A single set of blood pressure (systolic and diastolic) measurements were collected taken after the participant had rested for 5 minutes in the sitting position. Change from Baseline values for systolic and diastolic BP (SBP and DBP) at Week 24 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization which records both systolic and diastolic BP (generally Screening but could be a test repeat).|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
1318372|NCT02341859|Secondary|Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours||||participants|||Number
1318254|NCT02345161|Secondary|Change From Baseline in QTcB at Week 52|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24, and Week 52 or IP Discontinuation Visit. Change from Baseline in QTcB was summarized for each post-Baseline assessment up to Week 52. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Msec||Standard Deviation|Mean
1318255|NCT02345161|Secondary|Change From Baseline in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Week 24|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in QTcB was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Msec||Standard Deviation|Mean
1318256|NCT02345161|Secondary|Change From Baseline in QTcF and PR Interval at Week 52|Single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24 and Week 52 or IP Discontinuation Visit. Change from Baseline in ECG QTcF and PR interval was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).|Baseline and Week 52|Extension Population|||Msec||Standard Error|Least Squares Mean
1318257|NCT02345161|Secondary|Change From Baseline in Corrected QT Interval Using Fridericia’s Correction (QTcF) and PR Interval at Week 24|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in ECG QTcF and PR interval was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 24|ITT population|||Milliseconds (msec)||Standard Error|Least Squares Mean
1318258|NCT02345161|Secondary|Change From Baseline in Heart Rate at Week 52|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24 and Week 52 or IP Discontinuation Visit. Change from Baseline in ECG heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Bpm||Standard Deviation|Mean
1318259|NCT02345161|Secondary|Change From Baseline in Heart Rate at Week 24|A single 12-lead electrocardiogram (ECG) and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in ECG heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Beats per minute (Bpm)||Standard Deviation|Mean
1318260|NCT02345161|Secondary|Number of Participants With Any On-treatment CV Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Extension Part of the Study|Cardiovascular safety was monitored via AE reporting with categorization and analysis of adverse events of special interest (AESIs) including cardiac arrhythmia, cardiac failure, ischemic heart disease, hypertension, and central nervous system hemorrhages and cerebrovascular conditions. In addition, ECGs and vital signs were measured in all subjects and24-hour Holter monitoring was performed in a predefined subset. Pre-specified MACE analysis was conducted based on adjudicated CV deaths and investigator-reported non-fatal AEs. Number of participants with any of the following MACE events were to be included per the broad and narrow analyses: Broad MACE criteria (ischemic heart disease standardized MedDRA query [SMQ; myocardial infarction SMQ and other ischemic diseases]) and narrow MACE criteria (myocardial infarction [acute myocardial infarction]|Up to Week 52|Extension Population|||Participants|||Number
1318321|NCT02343081|Secondary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs and SAEs will be collected from the start of study treatment and until two weeks post last dose. If AEs or SAEs extend in time and are not resolved before the end of the 2-week follow up period, this period shall last until the event/s are resolved.|Up to two weeks post last dose|||||||
1318466|NCT02340000|Secondary|Willingness to Take the Study Antibiotic in the Future|whether participants said they would NOT take the antibiotic again|end of 10th day||||Participants|||Count of Participants
1318261|NCT02345161|Secondary|Number of Participants With Any On-treatment Cardiovascular (CV) Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Treatment Period|Cardiovascular safety was monitored via AE reporting with categorization and analysis of adverse events of special interest (AESIs) including cardiac arrhythmia, cardiac failure, ischemic heart disease, hypertension, and central nervous system hemorrhages and cerebrovascular conditions. In addition, ECGs and vital signs were measured in all subjects and24-hour Holter monitoring was performed in a predefined subset. Pre-specified MACE analysis was conducted based on adjudicated CV deaths and investigator-reported non-fatal AEs. Number of participants with any of the following MACE events were to be included per the broad and narrow analyses: Broad MACE criteria (ischemic heart disease standardized MedDRA query [SMQ; myocardial infarction SMQ and other ischemic diseases]) and narrow MACE criteria (myocardial infarction [acute myocardial infarction].|Up to Week 24|ITT Population|||Participants|||Number
1318262|NCT02345161|Secondary|Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study|All suspected pneumonias required confirmation as defined by the presence of new infiltrate(s) on chest x-ray AND at least 2 of the following signs and symptoms: Increased cough, Increased sputum purulence (colour) or production, Auscultatory findings of adventitious sounds , Dyspnea or tachypnea, Fever (oral temperature > 37.5 °C), Elevated WBC (>10,000/mm3 or >15 percent immature forms) orr Hypoxemia (HbO2 saturation <88 percent or at least 2 percent lower than Baseline value).|Up to Week 52|Extension Population|||Participants|||Number
1318263|NCT02345161|Secondary|Number of Participants With an On-treatment Penumonia Event in the Treatment Period|All suspected pneumonias required confirmation as defined by the presence of new infiltrate(s) on chest x-ray and at least 2 of the following signs and symptoms: Increased cough, Increased sputum purulence (colour) or production, Auscultatory findings of adventitious sounds , Dyspnea or tachypnea, Fever (oral temperature > 37.5 °C), Elevated white blood cells (WBC) (>10,000/millimeter [mm^3] or >15 percent immature forms) or Hypoxemia (hemoglobin/oxygen [HbO2] saturation <88 percent or at least 2 percent lower than Baseline value).|Up to Week 24|ITT Population.|||Participants|||Number
1318264|NCT02345161|Secondary|Number of Participants With Any On-treatment AE/SAEs in the Extension Part of the Study|An AE was any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. These included an exacerbation of a chronic or intermittent pre-existing condition. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or all events of possible drug-induced liver injury. Abnormal and clinically significant laboratory test results were also recorded as an AE or SAE. COPD exacerbations were an expected disease-related outcome and were not to be recorded as an AE, unless they met the definition of an SAE. Participants were not to be withdrawn from the study due to COPD exacerbations and their evaluation was an efficacy endpoint.|Up to Week 52|Extension Population|||Participants|||Number
1318265|NCT02345161|Secondary|Number of Participants With Any On-treatment Adverse Event (AE) and Serious Adverse Event (SAE) in the Treatment Period|An AE was any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. These included an exacerbation of a chronic or intermittent pre-existing condition. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or all events of possible drug-induced liver injury. Abnormal and clinically significant laboratory test results were also recorded as an AE or SAE. COPD exacerbations were an expected disease-related outcome and were not to be recorded as an AE, unless they met the definition of an SAE. Participants were not to be withdrawn from the study due to COPD exacerbations and their evaluation was an efficacy endpoint.|Up to Week 24|ITT Population|||Participants|||Number
1318266|NCT02345161|Secondary|Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52|The EXACT-PRO is a 14 item instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. EXACT-RS consists of 11 items from the 14 item EXACT-PRO instrument and has a scoring range of 0-40. Three subscales are used to describe different symptoms; dyspnoea (range 0-17), cough and sputum (range 0-11) and chest symptoms (range 0-12). Baseline was defined as the mean value during the period between Visits 1 and 2. Mean scores were calculated for each four weekly period and change from Baseline was calculated as four weekly score minus the Baseline value. Four weekly intervals were analyzed using a MMRM method with covariates of treatment group, smoking status (screening), geographical region, time period, baseline, baseline by time period and treatment by time period interactions. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).|Baseline to Week 52|Extension Population|||Scores on a scale||Standard Error|Least Squares Mean
1318267|NCT02345161|Secondary|Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24|The EXACT-PRO is a 14 item instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. EXACT-RS consists of 11 items from the 14 item EXACT-PRO instrument and has a scoring range of 0-40. Three subscales are used to describe different symptoms; dyspnoea (range 0-17), cough and sputum (range 0-11) and chest symptoms (range 0-12). Baseline was defined as the mean value during the period between Visits 1 and 2. Mean scores were calculated for each four weekly period and change from Baseline was calculated as four weekly score minus the Baseline value. Four weekly intervals were analyzed using a MMRM method with covariates of treatment group, smoking status (screening), geographical region, time period, baseline, baseline by time period and treatment by time period interactions. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).|Baseline to Week 24|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1318367|NCT02341859|Secondary|Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).|Baseline, 3 hours, 6 hours||||units on a scale||Standard Deviation|Mean
1318268|NCT02345161|Secondary|Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 52|The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, >=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1).|Up to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Exacerbations per participant per year||95% Confidence Interval|Mean
1318269|NCT02345161|Secondary|Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 24|The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, >=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1).|Up to Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Exacerbations per participant per year||95% Confidence Interval|Mean
1318270|NCT02345161|Secondary|Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 52|Participants were asked to complete the daily activity question as aprt of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline.|Up to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
1318271|NCT02345161|Secondary|Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 24|Participants were asked to complete the daily activity question as part of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline.|Up to Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
1318272|NCT02345161|Secondary|Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 52|The TDI measures change in the participant’s dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Weeks 4, 24 and 52. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions|Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1318273|NCT02345161|Secondary|Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24|The TDI measures change in the participant’s dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Week 4 and Week 24. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions.|Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1318274|NCT02345161|Primary|Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52|The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 52 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions.|Baseline to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1318368|NCT02341859|Secondary|Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).|Baseline and 6 hours||||units on a scale||Standard Deviation|Mean
1318275|NCT02345161|Primary|Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24|The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 24 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions|Baseline to Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1318276|NCT02345161|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 52 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. Extension Population: all participants in the ITT Population who were enrolled into the subset of participants with extension to 52 weeks.|Baseline to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
1318277|NCT02345161|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. ITT Population comprised of all randomized subjects excluding those who were randomized in error. Only participants with analyzable data at the given time point were analyzed.|Baseline to Week 24|ITT Population|||Liters (L)||Standard Error|Least Squares Mean
1318278|NCT02345031|Secondary|Pharmacokinetic of AUT00063, Plasma Levels|Exposure of AUT00063 ng/ml, in plasma levels at Day 28|28 Days||||ng||Standard Deviation|Mean
1318279|NCT02345031|Secondary|To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG|Number of Subjects With At Least One Treatment Emergent Adverse Event|42 Days||||Participants|||Count of Participants
1318280|NCT02345031|Secondary|Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28|Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population|28 days|FAS Population|||ms||95% Confidence Interval|Least Squares Mean
1318281|NCT02345031|Secondary|Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28|Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population|28 days|FAS Population|||ms||95% Confidence Interval|Least Squares Mean
1318282|NCT02345031|Primary|Change in Hearing Loss After 4 Weeks of Treatment|To compare the change in hearing using the QuickSIN test (speech in noise performance) from baseline (Day 1 to Day 28) between AUT00063 and placebo. The QuickSIN test measures the level of signal compared to the noise that is required to achieve 50% recognition. The test is administered in a sound booth at 70-dB HL binaurally via insert-ear phones. Three lists are administered to each individual subject and the threshold or 50% signal-to-noise ratio (SNR) is calculated as the mean of the three lists completed. Each list consists of six sentences with five key words to be scored per sentence. The sentences are presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult).|28 days|Full Analysis Set|||decibels (dB)||95% Confidence Interval|Least Squares Mean
1318283|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|15 min after removal of the urodynamics catheters||||units on a scale||Full Range|Median
1318284|NCT02344745|Secondary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|15 min after removal of the urodynamics catheters||||cm||Full Range|Median
1318285|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|At the time of catheter placement||||units on a scale||Full Range|Median
1318286|NCT02344745|Primary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|At the time of catheter placement||||cm||Full Range|Median
1318287|NCT02344407|Primary|Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.|Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry|One month|Participants with 1-month antibody data without elevated antibody levels at entry|||EU/mL||95% Confidence Interval|Geometric Mean
1318288|NCT02344407|Primary|Serious Adverse Events.|Number of Participants Experiencing Serious Adverse Events in First 30 Days|One month|All Participants Randomized|||Participants|||Count of Participants
1318289|NCT02344342|Secondary|Days to Hospitalization or Death (if it Occurs Within 180 Days)|Time to Hospitalization (if participant was hospitalized and did not die) or death whichever came first. In fact all participants who died in the follow up period were hospitalized first, so actual data reported below also represents time to hospitalization for all participants.|180 days|All participants who completed 180 days or died prior to 180 days (all who completed study and all listed in all cause mortality)|||days till hospitalization||95% Confidence Interval|Mean
1318291|NCT02344342|Secondary|Self Care for Heart Failure Index Score|The self care for heart failure index score ranges from 22 to 88 where 22 is the lowest score meaning cares for oneself least well and 88 means one is most confident or able to care for oneself properly.|180 day follow up|Two participants completed the study but did not answer all of the questions on this questionnaire, and therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.|||units on a scale||Full Range|Mean
1318292|NCT02344342|Primary|Number of Days Hospitalized or Dead in the 180 Day Follow up Period|This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm.|180 days (6 months)|The subjects included in this measure each completed the 180 follow up period or died within the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.|||Days|||Number
1318293|NCT02344251|Secondary|Safety Assessment: Rates of Adverse Events Reported|A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events.|30 days||||percentage of participants reporting AEs|||Number
1318294|NCT02344251|Primary|Medication Adherence|The primary outcome will be medication adherence as measured by percentage of doses taken among groups.|30 days||||percentage of doses taken||95% Confidence Interval|Number
1318295|NCT02343627|Primary|Number of Participants With Negative Fungal Culture|To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days|28 days||||Participants|||Count of Participants
1318296|NCT02343380|Secondary|Intra-individual Variations in the Values of Glucagon-like Peptide-1 After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min|These variables were not measured, since data were not collected.||||||
1318297|NCT02343380|Secondary|Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||ng/l x h||95% Confidence Interval|Mean
1318298|NCT02343380|Secondary|Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||ng/l x h||95% Confidence Interval|Mean
1318299|NCT02343380|Secondary|Variation in Morning Triglyceride and Free Fatty Acid (FFA) Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Triglycerides and FFA values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.~FFA concentrations were measured by a fluorometric assay. Plasma triglycerides were assayed by enzymatic colorimetric method.~Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min||||mmol/l*h||95% Confidence Interval|Mean
1318300|NCT02343380|Secondary|Variation in Morning Glucose and Insulin Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Glucose and insulin values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.~Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min||||ug/ml*h||95% Confidence Interval|Mean
1318301|NCT02343380|Primary|Intra-individual Variation in Morning Diet-induced Thermogenesis (DIT) Evaluated by Calorimetric Exam After the Consumption of a Meal at 8:00 am Compared With Evening DIT Evaluated by Calorimetric Exam After the Consumption of the Same Meal at 8:00 pm|Indirect calorimetry by Deltatrac II (DATEX, Division of Instruments Corp. Helsinki, Finland) is used to measure the rate of energy expenditure before- and after- the meal.Diet-induced thermogenesis is considered as the difference between average after-meal and basal energy expenditure.|Before and 180-min from the beginning of the meal||||kcal/min||95% Confidence Interval|Mean
1318302|NCT02343263|Secondary|Time to Return to Normal Activity|The postoperative pain assessment sheets will contain a daily entry for the estimated number of postoperative days until patient returned to normal activity level.|10 days|data not collected||||||
1318303|NCT02343263|Secondary|Postoperative Nausea & Emesis|The postoperative pain assessment sheets will contain a daily entry for the estimated number of episodes of vomiting the patient experienced.|10 days|data not collected||||||
1318304|NCT02343263|Secondary|Number of Required Calls to Healthcare Personnel (Either the Clinic or the Physician on Call Overnight)|The postoperative pain assessment sheets will contain a daily entry for the estimated number of required calls to the clinic or to the physician on call overnight.|10 days|data not collected||||||
1318305|NCT02343263|Secondary|Time to Return to Normal Diet|The postoperative pain assessment sheets will contain a daily entry for the estimated number of postoperative days until patient returned to normal diet.|10 days|data not collected||||||
1318306|NCT02343263|Secondary|Total Pain Medication Usage|The postoperative pain assessment sheets will contain a daily entry for the estimated total doses of pain medication required and will distinguish between the need for narcotic and non-narcotic pain medication requirements.|10 days|data not collected||||||
1318307|NCT02343263|Primary|Postoperative Pain; Study Terminated Due to FDA Requirement for a Investigational New Drug Application Requirement|Parents/caregivers will be asked to perform thrice daily pain assessments utilizing a validated postoperative pain measurement scale for the 10 days after surgery. study terminated due to FDA requirement for a investigational new drug application requirement|10 days|data not collected||||||
1318369|NCT02341859|Secondary|Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).|Baseline, 3 hours, 6 hours||||units on a scale||Standard Deviation|Mean
1318308|NCT02343263|Primary|Postoperative Hemorrhage; Study Terminated Due to FDA Requirement for a Investigational New Drug Application Requirement|Tonsillectomy (and adenotonsillectomy) are associated with a 3-5% postoperative hemorrhage risk from the tonsillectomy wound beds across the United States; our institution has a calculated average of between 4% - 5%. Parents will be contacted 2 to 3 weeks following their procedure and inquiries about post-operative bleeding will be made. Bleeding >1 tablespoon or that requires A) presentation to an emergency department, B) admission to a hospital, or C) return to the operating room will be considered significant post-operative hemorrhage. Distinction will also be made between early (<24 hours after surgery) and late (>24 hours after surgery) postoperative bleeding. The bleeding risk after 2 weeks from surgery is exceedingly small. No prior studies have identified any increased risk with utilizing either fibrin sealant or bupivacaine. This study will evaluate whether the intervention reduces bleeding risk.|14 days|Data not collected||||||
1318309|NCT02343159|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318310|NCT02343159|Secondary|Multiple Sclerosis Impact Scale (MSIS-29)|The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participants perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318311|NCT02343159|Secondary|Compliance Rates at Month 6 and 12|Compliance rates defined as the proportion of actual DMF doses taken per label according to feedback from MEMS data over total expected DMF doses per label during treatment period.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318312|NCT02343159|Secondary|Persistence Rates at Months 6 and 12|Persistence rates defined as the proportion of time on treatment over the study observation time period.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318313|NCT02343159|Secondary|Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 6|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318314|NCT02343159|Secondary|Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 6|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318315|NCT02343159|Secondary|Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318316|NCT02343159|Primary|Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318317|NCT02343081|Primary|AUC0-∞|Extent of absorption of Temozolomide from time (0) to infinity (∞) will be measured after oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.|||mcg*h/mL||Standard Deviation|Mean
1318318|NCT02343081|Primary|AUC0-t|Extent of absorption of Temozolomide from time (0) to the last quantifiable concentration (t) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough)|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.|||mcg*h/mL||Standard Deviation|Mean
1318319|NCT02343081|Other Pre-specified|T1/2|Time required for Temozolomide plasma concentration to decrease by 50%|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4||||hours||Standard Deviation|Mean
1329616|NCT02107014|Primary|Change in IL-7 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1318322|NCT02343081|Primary|Cmax|Rate of absorption of Temozolomide (Cmax) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.|||mcg/mL||Standard Deviation|Mean
1318323|NCT02343003|Other Pre-specified|Medication Usage|Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.|6 months and 12 months|17 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 25 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 17/76 in Cooled radiofrequency group and 2/75 in Corticosteroid injection group completed.|||milligrams||Standard Deviation|Mean
1318324|NCT02343003|Other Pre-specified|Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater|"Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months. The study subjects’ perception of treatment effect was reflected by the Global Perceived Effect (GPE). The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever."|6 months and 12 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 4/75 in Corticosteroid injection group completed.|||Participants|||Count of Participants
1318325|NCT02343003|Secondary|Oxford Knee Score|"Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months. The Oxford Knee Score is determined by a 12-question survey that measures knee function, and is scored on a scale that ranges from 0 - 48 points, with scores of 0 - 19 = severe arthritis, 20 - 29 = moderate to severe arthritis, 30 - 39 = mild to moderate arthritis, and 40 - 48 = satisfactory joint function."|6 months and 12 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 3/75 in Corticosteroid injection group completed.|||units on a scale||Standard Deviation|Mean
1318326|NCT02343003|Secondary|Numeric Rating Scale|"The number of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain."|12 months|52 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 12 month outcome. 4 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 12 month outcome.|||Participants|||Count of Participants
1318327|NCT02343003|Primary|Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.|Safety Endpoint: Number of subjects experiencing adverse events through final follow up.|6 months and 12 months||||Participants|||Count of Participants
1318328|NCT02343003|Primary|Numeric Rating Scale (NRS)|"The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain."|6 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 68 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome.|||Participants|||Count of Participants
1318329|NCT02342704|Secondary|Change From Baseline in SDMT at Week 52|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Baseline, Week 52|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
1318330|NCT02342704|Secondary|Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
1318331|NCT02342704|Secondary|Time to Complete Recovery From First Relapse|12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318332|NCT02342704|Secondary|Cumulative Risk of Relapse|A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318333|NCT02342704|Secondary|Time to First Relapse|A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318551|NCT02336763|Secondary|Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4||Within 3 months of study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
1318334|NCT02342704|Secondary|Proportion of Participants With No Evidence of Disease Activity (NEDA)|NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318335|NCT02342704|Secondary|Cumulative Number of New or Enlarging T2 Lesions||Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.|||lesions||Standard Deviation|Mean
1318336|NCT02342704|Secondary|Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52|As assessed by MRI.|Baseline, Week 52|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.|||percentage change||Standard Deviation|Mean
1318337|NCT02342704|Secondary|Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24|As assessed by magnetic resonance imaging (MRI).|Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.|||percentage change||Standard Deviation|Mean
1318338|NCT02342704|Secondary|Cumulative Number of New T1-Gd+ Lesions||Baseline, Week 4, Week 12, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment.|||lesions||Standard Deviation|Mean
1318339|NCT02342704|Primary|Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions||Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1318340|NCT02342561|Secondary|Description of Bacterial Skin Flora|Macroscopically unique colonies are isolated and analysed using Matrix-Assisted Laser Desorption/Ionization Time Of Flight analysis (MALDI-TOF). Finding are reported as prevalence of unique organism growth in the study population|Samples collected 75 minutes after drape application are analysed||||No. of cases|||Number
1318341|NCT02342561|Primary|Bacterial Quantity|The bacterial quantity of the skin in sampled using the cylinder sampling method and incubated for 36-48 hours. Manually counted growth is reported as log10 Colony forming units (CFU)/cm^2|Measured after skin disinfection and 75 minutes after drape application||||Log10 CFU/cm^2||Inter-Quartile Range|Median
1318342|NCT02342548|Secondary|Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score|The Clinical Global Impression of Improvement (CGI-I) is a global measure of improvement or change based on the clinician’s assessment of all available clinical data obtained from interviewing the participant. The CGI-I consists of a single 7-point rating of total improvement or change from baseline severity, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, “Compared to your participant’s condition at the beginning of treatment, how much has he/she changed?” Scores are: 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse.|Month 6 and Month 12|Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.|||units on a scale||Standard Deviation|Mean
1318343|NCT02342548|Secondary|Change From Baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score|The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington’s disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Maximum Chorea (TMC) is a subset of the TMS assessment, and composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment is rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms.|Baseline (Day 1), Month 6, and Month 12|Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.|||Units on a scale||Standard Deviation|Mean
1318344|NCT02342548|Secondary|Change From Baseline in Unified Huntington’s Disease Rating Scale (UHDRS) Total Motor Score|The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington’s disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Motor Score (TMS) assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural ability. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.|Baseline (Day 1), Month 6, and Month 12|Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.|||units on a scale||Standard Deviation|Mean
1318345|NCT02342548|Primary|Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category|Columbia Suicide Severity Rating Scale (C-SSRS) was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior, and was used in this study. C-SSRS responses were mapped onto the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Number of participants with any of the following behaviors occurring since last visit was summarized: completed suicide; suicide attempt; preparatory acts towards suicide; suicidal ideation; self-injurious behavior (no suicidal intent).|Baseline (Day 1), Weeks 2 and 4, Months 3, 6, 9 and 12, follow-up visit (7-14 days after the last dose of Month 12)|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 time point.|||Participants|||Count of Participants
1318552|NCT02336763|Primary|Reduction in Liver Metastasis||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
1318346|NCT02342548|Primary|Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity|Adverse events related to extrapyramidal symptoms included dystonia, akathisia, tardive dyskinesia). Severity was assessed by the investigator. Mild means the AE didn't interfere with the participant's usual function. Moderate means the AE interfered to some extent the participant's usual function. Severe means the AE interfered significantly with the participant's usual function.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
1318347|NCT02342548|Primary|Number of Participants With Laboratory Test Abnormalities (Normal Baseline)|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
1318348|NCT02342548|Primary|Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality)|Number of participants with white blood cell (WBC) count and absolute neutrophil count (ANC) meeting the following criteria is presented: (1) WBC count <0.6 *the lower limit of normal (LLN); (2) WBC count >1.5 times the upper limit of normal (ULN); (3) ANC <0.8*LLN; and (4) ANC >1.2*ULN.|1 year|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.|||Participants|||Count of Participants
1318349|NCT02342548|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria|Maximum absolute values and increases from baseline were summarized for PR interval (interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of the S wave corresponding to ventricular depolarization), and QTcF interval (time from ECG Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia’s formula). Number of participants with ECG data meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=140 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval increase from baseline >=25/50 percent; (7) QRS complex increase from baseline >=50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.|1 year|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.|||Participants|||Count of Participants
1318350|NCT02342548|Primary|Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria|Number of participants with vital signs data meeting the following criteria is presented: (1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); (2) standing SBP <90 mmHg; (3) supine diastolic blood pressure (DBP) <50 mmHg; (4) standing DBP <50 mmHg; (5) supine pulse rate <40 beats per minute (bpm); (6) supine pulse rate >120 bpm; (7) standing pulse rate <40 bpm; (8) standing pulse rate >140 bpm; (9) maximum increase from baseline in supine SBP >= 30 mmHg; (10) maximum increase from baseline in standing SBP >= 30 mmHg; (11) maximum increase from baseline in supine DBP >= 20 mmHg; (12) maximum increase from baseline in standing DBP >= 20 mmHg; (13) maximum decrease from baseline in supine SBP >=30 mmHg; (14) maximum decrease from baseline in standing SBP >=30 mmHg; (15) maximum decrease from baseline in supine DBP >=20 mmHg; (16) maximum decrease from baseline in standing DBP >=20 mmHg.|1 year|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.|||Participants|||Count of Participants
1318351|NCT02342548|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
1318352|NCT02342548|Primary|Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study treatment and up to 28 calendar days after the last administration of study treatment that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
1318370|NCT02341859|Secondary|Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).|Baseline, 3 hours, 6 hours||||units on a scale||Standard Deviation|Mean
1318353|NCT02342535|Primary|Change in Physical Activity (Minutes/Week)|To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity. Time (pre/post-intervention) was treated as a binary variable in order to measure changes in physical activity. Models controlled for accelerometer wear time and weekend day.|Baseline and 4 months|We did not collect any data from the children, so all the data analysis is from the data obtained from the 30 mothers. To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity.|||minute/week activity||Standard Deviation|Mean
1318354|NCT02342418|Secondary|This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects|The maximum concentration or Cmax value is measured in units of milligrams of tedizolid per liter of plasma.This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.|12 months||||Milligram per Liter||Full Range|Mean
1318355|NCT02342418|Primary|This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.|The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.|12 months||||hour*milligram/Liter||Full Range|Median
1318356|NCT02342288|Secondary|Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients|The secondary outcome is to evaluate factors (age, gender, duration of procedure, blood loss, intraoperative fluids, blood pressure, and carbon dioxide levels) looking for correlations with intraocular pressure changes.|prone; every 15 minutes; 1 hr until end of surgery|||||||
1318357|NCT02342288|Primary|Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position|The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP – two eye average baseline IOP obtained at first prone measurement).|Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery|Subjects who were undergoing elective lumbar spine surgery.|||mm Hg||95% Confidence Interval|Mean
1318358|NCT02342223|Secondary|Dermatology Life Quality Index (DLQI)|To evaluate the effects of Voluma injections on the subject’s quality of life (QOL) using the Dermatology Life Quality Index (DLQI). The DLQI is a validated 10-item questionnaire encompassing six different domains of QOL, including symptoms and feelings, daily activities, leisure, work/school, personal relationships, and treatment. Each question has four possible responses: “not at all/not relevant,” “a little,” “a lot,” and “very much” that corresponds to scores of 0, 1, 2, and 3, respectively, and a higher score suggests a higher level of QOL impairment. DLQI total score may range between 0 to 30.|Baseline to 12 months||||scores on a scale||Standard Deviation|Mean
1318359|NCT02342223|Secondary|Subject Satisfaction Questionnaire (SSQ)|To evaluate the benefits and effects of Voluma injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.|12 months||||percentage of total participants|||Number
1318360|NCT02342223|Secondary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post- treatment photography by participants.|Baseline to 12 months||||Participants|||Number
1318361|NCT02342223|Secondary|Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated lipoatrophy over 12 months by assessing changes in the Carruthers Lipoatrophy Severity Scale (CLSS) based on pre/post intervention photography by principal investigator (PI). CLSS is a 4-point grading scale (1 to 4, with a greater number indicating higher severity of HIV FLA). Grade 1: mild and localized facial lipoatrophy. Grade 2: deeper and longer atrophy, with the facial muscles beginning to show through. Grade 3: atrophic area is even deeper and wider, with the muscles clearly showing. Grade 4: lipoatrophy covers a wide area, extending up toward the eye sockets, and the facial skin lies directly on the muscles.|Baseline to 12 months||||Participants|||Number
1318362|NCT02342223|Primary|Percentage of Participants With Device or Procedure Related Adverse Events|To evaluate the safety of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by monitoring the incidence of adverse events (patient will keep a daily diary for initial 1 month and weekly phone calls will be made by study coordinator for initial 1 month to document possible adverse events, including injection site reactions, redness, bruising, swelling, and induration).|12 months|Common, transient adverse events reported in subject diaries include as follows.|||percentage of total participants|||Number
1318363|NCT02342223|Primary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator|"To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post-treatment photography by principal investigator (PI). GAIS is a 5-point rating scale, ranging from worse, no change, improved, much improved, and very much improved."|Baseline to 12 months||||participants|||Number
1318364|NCT02342197|Primary|Number of Oocytes Retrieved||12 months||||oocytes||Standard Deviation|Mean
1318365|NCT02341859|Secondary|Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)|6 hours|Preference is missing for 1 participant in the stenfilcon A/delefilcon A group whom did not answer preference question of which lens is preferred.|||participants|||Number
1318366|NCT02341859|Secondary|Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).|6 hours||||units on a scale||Standard Deviation|Mean
1318373|NCT02341859|Secondary|Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline||||participants|||Number
1318374|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours||||participants|||Number
1318375|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline||||participants|||Number
1318376|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|6 hours||||participants|||Number
1318377|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|Baseline||||participants|||Number
1318378|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)|6 hours||||participants|||Number
1318379|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)|Baseline||||participants|||Number
1318380|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)|6 hours||||participants|||Number
1318381|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)|Baseline||||participants|||Number
1318382|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)|6 hours||||participants|||Number
1318383|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)|Baseline||||participants|||Number
1318384|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)|6 hours||||participants|||Number
1318385|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)|Baseline||||participants|||Number
1318386|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.|6 hours||||participants|||Number
1318387|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.|Baseline||||participants|||Number
1318388|NCT02341859|Primary|Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)|6 hours||||microns||Standard Deviation|Mean
1318389|NCT02341859|Primary|Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)|6 hours||||mm||Standard Deviation|Mean
1318390|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
1318391|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
1318392|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
1318393|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
1318394|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
1318395|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
1318396|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
1318397|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|"Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe)~N - nasal, T - temporal, S - superior, I - interior"|Baseline||||units on a scale||Standard Deviation|Mean
1318398|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
1318399|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
1318400|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
1318401|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
1318402|NCT02341482|Secondary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318403|NCT02341482|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318404|NCT02341482|Secondary|Number of Participants With Significant Change in Physical Examination From Previous Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318405|NCT02341482|Secondary|Number of Participants With Significant Change in Neurological Examination From Previous Examination|The extended neurological examination, performed by a board certified neurologist, included observations for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318467|NCT02340000|Secondary|Nasal Colonization With Resistant Bacteria|Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds).|baseline|All 231 participants were analyzed together regardless of treatment.|||Participants|||Count of Participants
1329617|NCT02107014|Primary|Change in IL-6 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1318406|NCT02341482|Secondary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) interval, beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, QT interval corrected for heart rate (QTc) interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline; and QTcF >=450 to <480, 480 to <500 and >=500 msec or >=30 to 60 msec increase and also >=60 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318407|NCT02341482|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate more than (<)40 or less than (>)120 beats per minute (bpm); systolic blood pressure (SBP) more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318408|NCT02341482|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], urine cotinine, and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318409|NCT02341482|Secondary|Apparent Oral Clearance (CL/F) of PF-04958242|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1318410|NCT02341482|Secondary|Predose Concentration (Ctrough) of PF-04958242||0 hour at Day 1,Day 2,Day 3,Day 4,Day 7,Day 10,Day 13,Day 16,and Day 17 (pre-dose)|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1318411|NCT02341482|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-04958242||Day 1 to Day 17|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1318412|NCT02341482|Secondary|Time for Cmax (Tmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.|||hours||Full Range|Median
1318413|NCT02341482|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1318414|NCT02341482|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval, Where Tau = 12 Hours (AUCtau) of PF-04958242|AUCtau = area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau = 12 hours. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 3(0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose),Day 17(0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.|||picogram*hours per milliliter pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1318415|NCT02341417|Secondary|Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time|"Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.~Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dL||Inter-Quartile Range|Median
1318553|NCT02336763|Primary|Progression-free Survival||Up to 5 years|Study terminated early no analysis conducted. Subjects would need to be followed for up to 5 years to answer this objective. Subject 1 was followed 5 months and subject 2 was followed 2 months. Therefore, data was not collected from any subject for this Outcome Measure.||||||
1318416|NCT02341417|Secondary|Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time|"Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.~Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dL||Inter-Quartile Range|Median
1318417|NCT02341417|Secondary|Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time|"Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.~Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||percent change||Inter-Quartile Range|Median
1318418|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28|"The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.~For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
1318419|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15|"The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.~Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
1318420|NCT02341417|Secondary|Serum Phosphorus at Baseline, Week 11, and Week 28|Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline, week 11 and week 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dl||Inter-Quartile Range|Median
1318421|NCT02341417|Secondary|Serum Corrected Calcium at Baseline, Week 11, and Week 28|Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline, week 11 and week 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dL||Inter-Quartile Range|Median
1318422|NCT02341417|Secondary|Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28|For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline and weeks 23 and 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||mg/dL||Inter-Quartile Range|Median
1318423|NCT02341417|Secondary|Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28|For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline and weeks 23 and 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||mg/dL||Inter-Quartile Range|Median
1318424|NCT02341417|Secondary|Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28|For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.|Weeks 23 and 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
1329618|NCT02107014|Primary|Change in IL-5 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1318425|NCT02341417|Secondary|Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28|"This endpoint was analyzed in participants who received SOC only in parent study 20130356.~For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded."|Extension study baseline and weeks 23 and 28|Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.|||percent change||Inter-Quartile Range|Median
1318426|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28|"This endpoint was analyzed in participants who received SOC only in parent study 20130356.~For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded."|Extension study baseline and weeks 23 and 28|Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
1318427|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15|"This endpoint was analyzed in participants who received SOC only in parent study 20130356.~Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded."|Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15|Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
1318428|NCT02341417|Primary|Number of Participants With Adverse Events|Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a “yes” or “no” response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?|From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.|All enrolled participants who received at least one dose of study drug in the extension study.|||Participants|||Count of Participants
1318429|NCT02341144|Secondary|PACU Length of Stay (LOS)|duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||minutes||Full Range|Median
1318430|NCT02341144|Secondary|PACU Morphine Equivalents|morphine equivalents received in PACU|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||mg/kg||Full Range|Median
1318431|NCT02341144|Secondary|Pain Score of Zero|"proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being no pain"|from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||Participants|||Count of Participants
1318432|NCT02341144|Secondary|Time to First Narcotic|duration until patient received first dose of narcotic in PACU|from entry in post-anesthesia care unit (PACU) to first narcotic||||minutes||Full Range|Median
1318433|NCT02341144|Primary|Post Operative Pain Rating|Using the Wong-Baker FACES Pain Rating Scale (WBFPRS)- pain scores range from zero (no pain) to ten (worst pain) and the average score was reported|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||units on a scale||Full Range|Mean
1318434|NCT02340715|Primary|Number of Participants Successfully Contributing MRI Data|We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.|up to 4 weeks from imaging||||Participants|||Count of Participants
1318435|NCT02340663|Secondary|Stability -- Number of Splints Dislodged During Maximum Openings|Count of the number of participants whose individual splints were dislodged at least once when participants opened as wide as possible and then closed. The task was repeated five times. Counts are partitioned into the number dislodged < 1 mm, number dislodged between 1 - 2 mm, number dislodged between 2 - 3 mm, number dislodged between 3 - 4 mm and number dislodged between 4 - 5 mm.|4 Months|Data not available for one participant in the Michigan bite splint group.|||Participants|||Count of Participants
1318436|NCT02340663|Secondary|Stability -- Number of Splints Dislodged by Tapping|Count of the number of participants whose individual splints were dislodged at least once when participants tapped their teeth on the splint 5 times. Counts are partitioned into the number dislodged < 1 mm, and those dislodged between 1 - 2 mm.|4 months|Data not available from one participant in the Michigan bite splint group.|||Participants|||Count of Participants
1318437|NCT02340663|Secondary|Stability -- Number of Splints Dislodged During Border Movement Trials|Count of the number of participants whose individual splints were dislodged at least once when participants performed grinding-like movements of the teeth against the splint in extreme positions. These extreme movements and positions were performed 5 times. Counts are partitioned into those dislodged > 1 mm, those dislodged between 1 - 2 mm, those dislodged 2 - 3 mm, those dislodged 3 - 4 mm, those dislodged 4 - 5 mm, those dislodged 5 - 6 mm and those dislodged > 6 mm.|4 months|Data not available for one participant in the Michigan bite splint group.|||Participants|||Count of Participants
1318438|NCT02340663|Secondary|Stability -- Number of Splints Dislodged by Grinding|Count of the number of participants whose individual splints were dislodged at least once when participants ground their teeth against the splint to the left (5 times), to the right (5 times, and front to back (5 times). Count is partitioned into those dislodged by < 1 mm, between 1 - 2 mm, between 2 - 3 mm, between 3 - 4 mm, and > 6 mm. Categories between 4 and 6 mm are not included, as no splints fell into this range.|4 Months|Data not available for one participant in the Michigan bite splint group.|||Participants|||Count of Participants
1319133|NCT02320838|Secondary|Baseline Mechanical Pain Threshold|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|Baseline at 0 min.||||N||Standard Deviation|Mean
1318439|NCT02340663|Secondary|Stability -- Number of Splints Dislodged by Clenching|Count of the number of participants whose individual splints were dislodged at least once when participants clenched their teeth against the splint five times. Numbers are sorted into those that moved < 1 mm, those that moved between 1 - 2 mm, those that moved between 2 - 3 mm and those that moved > 6 mm during the performance of five repeats of clenching. Categories from 3 mm to 6 mm are not included, because no splints fell into this range of values.|4 months|Data not available for one participant in the Michigan bite splint group|||Participants|||Count of Participants
1318440|NCT02340663|Secondary|Stability -- Splint Movement During Jaw Movement Tasks|Movement of each subject's splint on the teeth, due to rocking or dislodgement, measured in millimeters during five repetitions of the following five tasks: clenching, grinding, moving jaw to extreme positions on the splint, tapping, opening maximally. For control, movements of the splint while the jaw was in a rest position (teeth apart, jaw relaxed) were also measured. The maximum movement during the five repetitions of each task was calculated for each subject and used in statistical analyses.|4 months|Data not available for one participant in the Michigan bite splint treatment group.|||millimeters||Standard Deviation|Mean
1318441|NCT02340663|Secondary|Fabrication Efficacy -- Oral Health Modified Gingival Index|Gums or gingiva around each tooth is quantified for absence of inflammation (0), mild inflammation around part of the gingiva next to the tooth (1), mild inflammation involving all of the gingiva next to the tooth (2), moderate inflammation (3), or severe inflammation (4). Average scores are created for the cheek side of the upper teeth (Buccal Upper), palate side of upper teeth (Lingual Upper), cheek side of lower teeth (Buccal Lower) and tongue side of lower teeth (Lingual Lower). Mean and standard deviation scores for each of these regions and for week 1 and month 4 are shown as descriptive statistics; statistical results for the between-subject effects are reported. Overall means for each treatment group (SOVA and Michigan splints) are also reported.|1 week and 4 months||||Units on a scale||Standard Deviation|Mean
1318442|NCT02340663|Secondary|Fabrication Efficacy -- Oral Health Plaque Index|The Rustogi et al. Modification of the Navy Plaque Index method of scoring plaque was used. This involves dividing the cheek-facing (Buccal) and the tongue/palate-facing (Lingual) surfaces of each tooth into 9 regions and scoring whether disclosed plaque is present (1) or absent (0) in each of these 9 regions. The total number of regions with plaque was then tabulated as the proportion of total regions for four mouth areas, viz., the cheek sides of the upper teeth (Buccal Upper), the cheek sides of the lower teeth (Buccal Lower), the palate sides of the upper teeth (Lingual Upper) and the tongue sides of the lower teeth (Lingual Lower). Overall means for each treatment group (SOVA and Michigan splints) are also reported.|1 week and 4 months||||proportion of total regions||Standard Deviation|Mean
1318443|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness|Splints were evaluated for sensation of tightness on the teeth. SOVA splints that were said to be too tight by the participants and that subsequently required intervention by the attending dentist to fix were graded as 1 (poor adaptation); Michigan splints that were said to be too tight by the participants and that required the attending dentist to spend > 15 minutes of the delivery appointment to fix were graded as 1 (poor adaptation); all splints not meeting these criteria were scored as 0 (good adaptation). Total participants in each group with poorly adapted splints is reported.|Day of Delivery||||Participants|||Count of Participants
1318444|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material|Splint rims were evaluated for thickness. Splints requiring modification by the attending dentist to remove excess material were graded as 1 (poor adaptation); splints that did not require removal of excess material were graded as 0 (good adaptation). Number of participants in each group whose splint manifest poor adaptation is reported.|Day of Delivery||||Participants|||Count of Participants
1318445|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation|Lip- and cheek-sides of splints were evaluated for contact with the premolar and molar teeth. Splints lacking contact (> 1 mm space between splint and teeth) were graded as 1 (poor adaptation); splints with < 1 mm space between splint and teeth, from molar to molar as 0 (good adaptation). Inter-proximal contacts Number of total participants with splints in each group with poor adaptation is reported.|Day of Delivery||||Participants|||Count of Participants
1318446|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation|Palate-side of splints was evaluated for contact with the palate. Splints that were > 1 mm from contact with palate, from molar to molar were graded as 1 (poor adaptation); splints in continuous contact or lacking contact < 1mm with palate, from molar to molar were graded as 0 (good adaptation). Number of participants with splints in each group with poor adaptation is reported.|Day of delivery||||Participants|||Count of Participants
1318447|NCT02340663|Secondary|Fabrication Efficacy -- Retention Trials, Month 4|Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.|4 months|Data not available for one SOVA participant.|||Number of occurrences out of 40.||Standard Deviation|Mean
1318448|NCT02340663|Secondary|Fabrication Efficacy -- Retention Trials Week 1|Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.|1 week|Data not available for one SOVA participant.|||Occurrences||Standard Deviation|Mean
1318449|NCT02340663|Secondary|Fabrication Efficacy -- Estimated Bite Forces During Stability Testing|Estimated bite forces in kilograms associated with performing each of the following tasks: moving the jaw in extreme positions with pressure against the splint (Border), clenching (Clench), grinding side to side (Grind Lateral), grinding front to back (Grind Protrusive), tapping hard on splint (Tap). Overall means for each treatment group (SOVA and Michigan splints) are also reported.|4 months||||kilograms||Standard Deviation|Mean
1318450|NCT02340663|Secondary|User Satisfaction -- Self-Report of Splint Fit|"Responses to the question, The splint fits well with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out during the final appointment."|4 months||||Units on a scale||Standard Deviation|Mean
1318451|NCT02340663|Secondary|User Satisfaction -- Ease of Instructions|"Responses to the question, The instructions were easy to follow with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants."|On day of delivery|One SOVA bite splint participant did not respond to this question. Michigan bite splint participants did not fabricate their splints; hence, this question was irrelevant for them.|||Participants|||Count of Participants
1318452|NCT02340663|Secondary|User Satisfaction -- Ease of Fabrication|"Responses to the question, The splint was easy to fabricate with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants."|On day of delivery|One SOVA bite splint participant did not respond. Participants with the Michigan bite splint did not fabricate their splints; hence, this question is irrelevant to them.|||Participants|||Count of Participants
1318453|NCT02340663|Secondary|Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation|"Responses to the question, The splint relaxes my jaw muscles. with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months||||Units on a scale||Standard Deviation|Mean
1318454|NCT02340663|Secondary|Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism|"Responses to the question, The splint helps my bruxism. with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months|Question not answered by one SOVA participant.|||Units on a scale||Standard Deviation|Mean
1318455|NCT02340663|Secondary|Functional Efficacy -- Tooth Wear|Tooth wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the teeth in the lower jaw on the delivery data were combined with high-resolution, computer-scanned models of the same teeth and jaw after 4 months of splint wear. Sites where teeth showed cratering due to dentin exposure were targeted to make these measurements. Changes in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of dentin exposure areas (~ 1 millimeter in diameter). Group means were compared with t-tests.|4 months|Mandibular models were not available for two SOVA patients.|||millimeters||Standard Deviation|Mean
1318456|NCT02340663|Secondary|Compliance -- Use of Alternative Devices|"Responses to the question, I use an additional splint with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months||||Units on a scale||Standard Deviation|Mean
1318457|NCT02340663|Secondary|Compliance -- Appliance Removal at Night|"Responses to the question, I frequently remove the splint during the night with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months||||Units on a scale||Standard Deviation|Mean
1318458|NCT02340663|Secondary|Splint Material Loss / 4 Months.|Splint wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the splint on the delivery date were combined with high-resolution, computer-scanned models of the same splint after 4 months of wear. Sites where teeth contacted the splints were identified, and material loss in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of a tooth cusp (~ 3 millimeters in diameter). Group means were compared with t-tests.|4 months|Three SOVA subjects and 1 Michigan subject were not included in the analysis, because the scanned models could not be successfully aligned. This was likely due to a warpage of the impressions taken, warpage in the stone models that were scanned, or error in the model scanning process.|||millimeters||Standard Deviation|Mean
1318459|NCT02340663|Secondary|Number of Bruxing Events Per Hour Sleep Per Night.|Polysomnographic monitors were used to evaluate masticatory muscle activity during sleep. Activity of jaw closing muscles found in the cheeks (masseter muscles) occur in bursts, where a burst is taken as evidence for a jaw clench. The total number of bursts recorded during the night was tabulated and then divided by the total hours of sleep. Means presented are based on data gathered on night 122 (4 months of splint wear) and compared with ANOVA.|4 months|Polysomnographic data were not available from 5 SOVA and 3 Michigan splint subjects due to data corruption. Corruption typically occurs when a subject either removes the device or an electrode while sleeping, or the recorded data are too noisy to analyze due to electronic interference while the subject is asleep.|||muscle bursts / hour||Standard Deviation|Mean
1318460|NCT02340663|Primary|Total Number of Nights of Splint Wear for Four Months Per Subject.|Count of the total number of entire nights that subjects wore the splint provided to them in the study.|4 months||||nights||Standard Deviation|Mean
1318461|NCT02340520|Secondary|Change in HDAC2 Levels|circulating Histone Deacetylase2 levels measured in blood sample|Baseline, Week 1 and 2||||µM/µg||Standard Error|Mean
1318462|NCT02340520|Primary|Bronchodilation|Change in FEV1 L and FVC L|Baseline, Week 1 and 2||||liters||Standard Deviation|Mean
1318463|NCT02340338|Secondary|Number of Participants With Seroconversion|ELISA IgG against rTSST-1|through day 70||||participants|||Number
1318464|NCT02340338|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Clinical observations and clinical laboratory values|through day 70||||participants with any solicited AE|||Number
1318465|NCT02340104|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose|AUC[0-∞] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng*h/mL).|Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose|All participants who received at least 1 dose of study drug.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1318468|NCT02340000|Secondary|SNOT-16 - Day 10|"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.~The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10)."|day 0, end of 10th day|The number of participants who gave ratings at day 10.|||units on a scale||Standard Deviation|Mean
1318469|NCT02340000|Secondary|Subjective Improvement - Day 10|"rating of a lot better or no symptoms"|end of 10th day|The number of participants who gave a rating at day 10.|||Participants|||Count of Participants
1318470|NCT02340000|Secondary|SNOT-16 - Day 3|"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.~The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3)."|day 0, end of 3 days of treatment|The number of participants who gave ratings at day 3.|||units on a scale||Standard Deviation|Mean
1318471|NCT02340000|Primary|"Subjective Improvement - Day 3 (Rating of a Lot Better or no Symptoms)"|"rating of a lot better or no symptoms"|end of 3 days of treatment|The number of participants who gave ratings at the end of day 3 of treatment|||Participants|||Count of Participants
1318472|NCT02339831|Secondary|General Pain|"Self-reported total pain medication consumption was recorded by patients and at the end of the four-week period converted into standard units for comparison as oxycodone equivalent dosage."|4-6 weeks post-op||||mg||Standard Deviation|Mean
1318473|NCT02339831|Secondary|General Functional Orthopaedic Outcome Measures|Knee society score is an objective patient reported outcome survey to measure a patient's functional ability before and after knee arthroplasty. It is measured on a scale of 1-100. A score between 80-100 indicated excellent functioning, a score between 70-79 indicates good functioning, a score between 60-69 indicates fair functioning, and a score below 60 indicates poor functioning.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
1318474|NCT02339831|Secondary|General Activity Orthopaedic Outcome Measures|Western Ontario and McMaster Universities Arthritis Index is measured on a scale of 0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
1318475|NCT02339831|Secondary|General Mental Orthopaedic Outcome Measures|Short form 36 mental health score. The scale is measured from 0-100. 0 is the lowest or worst possible level of functioning and 100 is the highest or best possible level of functioning.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
1318476|NCT02339831|Primary|Early Functional Outcome Knee Flexion|Knee-flexion was measured using an 8-inch goniometer.|4-6 weeks post op||||degrees||Standard Deviation|Mean
1318477|NCT02339831|Primary|Early Function Outcome Kinesthesia|Kinesthesia was measured by recording the angle of the flexed knee and documenting how close the patient was able to reproduce the angle with closed eyes. The differences were recorded in degrees using an 8-inch goniometer.|4-6 weeks post op||||degress||Standard Deviation|Mean
1318478|NCT02339831|Primary|Early Functional Outcome Proprioception|Biodex Balance Machine Score. The system consists of a multiaxial standing platform with a maximum tilt of 20 degrees. All participants were tested on level 8, and a balance index was calculated using the time and deviation (in degrees) on the platform relative to a neutral position. The normal range for adults 54-71 is 1.79 – 3.35. Lower values indicate better/greater stability.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
1318479|NCT02339831|Primary|Early Functional Outcome by Sit to Stand Test|"Sit-to-Stand test: After one demonstration of the sit-to-stand test, standing up from a seated position without support, two tests were timed and the better value recorded. Patient was asked to sit with back against chair and told to stand up without using any support. Arms were suggested to be folded in front of chest. Time started with recorded said Go."|4-6 weeks post-op||||seconds||Standard Deviation|Mean
1318480|NCT02339831|Primary|Early Functional Outcome Strength|Quadriceps strength measurements using a hand held dynamometer|4-6 weeks post-op||||newton meter||Standard Deviation|Mean
1318481|NCT02339584|Primary|Mean Diurnal IOP Change From Baseline at Month 3|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Month 3|Per Protocol Analysis Set. Missing Month 3 data were imputed using a last observation carried forward method (LOCF).|||mmHg||Standard Error|Mean
1318482|NCT02339506|Other Pre-specified|Hippocampal Memory (Paired Associative Learning Task)|Hippocampal memory will be evaluated pre and post with a paired associative learning task|1 day after ACTH||2018-12-31|12/2018||||
1318483|NCT02339506|Other Pre-specified|Pain (Quantitative Sensory Testing Using a Thermal Pain Testing Device)|Alterations in pain sensing will be evaluated pre and post with quantitative sensory testing using a thermal pain testing device, to evaluate the delayed effect of cosyntropin infusions.|1 day after ACTH||2018-12-31|12/2018||||
1318484|NCT02339506|Primary|Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)|Cardiovagal baroreflex sensitivity will be measured with the Modified Oxford Technique before, during, and after drug infusions, to evaluate the effects of cosyntropin infusions.|Baseline, 4-hours after infusion, 24-hours after infusion||||ms/mmHg||Standard Deviation|Mean
1318485|NCT02339389|Secondary|If Maternal Temperature Increases During Labor Analgesia|If maternal temperature increases during labor analgesia|4 hours||||Degree F||Standard Deviation|Mean
1318486|NCT02339389|Primary|Changes in Maternal Ventilation During Labor Analgesia|If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval|Ventilation parameters measured at 2 hour and 4 hour||||L/min||Standard Deviation|Mean
1318520|NCT02338492|Secondary|Summary of Change From Baseline Range of Motion by Visit and Test|Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm.|Baseline, 90, 180 and 360 Days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||degrees||Standard Deviation|Mean
1318487|NCT02339285|Other Pre-specified|Clinical Global Impressions (CGI) Raw Score|"This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 Severity of Illness on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients."|Day 5; F2 (4 weeks after completion of treatment)||||units on a scale||Standard Deviation|Mean
1318488|NCT02339285|Other Pre-specified|Change in Beck Depression Inventory (BDI) Score|This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms.|Baseline to Day 5; Baseline to F2||||units on a scale||Standard Deviation|Mean
1318489|NCT02339285|Other Pre-specified|Change in Montreal Cognitive Assessment (MoCA) Score|This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline.|Baseline to F2||||units on a scale||Standard Deviation|Mean
1318490|NCT02339285|Other Pre-specified|Change in Hamilton Depression Rating Scale (HDRS) Score|The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms.|Baseline to Day 5 of Stimulation; Baseline to F2||||units on a scale||Standard Deviation|Mean
1318491|NCT02339285|Secondary|Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention|The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.|Baseline to F2|Only participants that completed all sessions are used in this task (per protocol participants); N = 26|||decibel (dB)||Standard Deviation|Mean
1318492|NCT02339285|Secondary|Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation|The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.|Baseline to Day 5 of Stimulation|Only participants that completed all sessions are used in this task (per protocol participants); N = 26|||decibel (dB)||Standard Deviation|Mean
1318493|NCT02339285|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms.|Baseline to F2 (4 weeks after completion of the intervention)||||units on a scale||Standard Deviation|Mean
1318494|NCT02339246|Primary|Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate AUC(0-24).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.|||hr*ng/mL||Standard Deviation|Mean
1318495|NCT02339246|Primary|Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate C(max).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.|||ng/mL||Standard Deviation|Mean
1318496|NCT02339246|Primary|Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate T(max).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.|||hour||95% Confidence Interval|Median
1323308|NCT02226198|Secondary|HDL-C (mmol/L)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
1318497|NCT02339155|Secondary|Number of Participants With Urinalysis Parameters|Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters.|Day 57|Safety Population|||Participants|||Number
1318498|NCT02339155|Secondary|Number of Participants With Clinical Chemistry Parameters Outside Normal Range|Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Day 57|Safety Population.|||Participants|||Number
1318499|NCT02339155|Secondary|Number of Participants With Hematology Parameters Outside Normal Range|Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Day 57|Safety Population|||Participants|||Number
1318500|NCT02339155|Secondary|Change From Baseline in Temperature at Indicated Time Points|Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Degree celsius||Standard Deviation|Mean
1318501|NCT02339155|Secondary|Change From Baseline in Respiratory Rate at Indicated Time Points|Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Breaths per minute||Standard Deviation|Mean
1318502|NCT02339155|Secondary|Change From Baseline in Heart Rate at Indicated Time Points|Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
1318503|NCT02339155|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1318504|NCT02339155|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA.|Up to Day 183|Safety Population|||Participants|||Number
1318505|NCT02339155|Secondary|Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups|The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a >4-fold increase in toxin neutralizing activity [TNA] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay.|Days 29, 57 and 183|PP Population.|||Percent of Participants||95% Confidence Interval|Number
1318506|NCT02339155|Secondary|Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups|Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Days 57 and 183|PP Population.|||µg/mL||95% Confidence Interval|Geometric Mean
1318521|NCT02338492|Secondary|Summary of Procedure and Device-Related Complications Rate|Procedure and device-related complications rate presented at follow-up visits|up to day 90, up to day180 since day 90, up to 360 since day 180||||Participants|||Count of Participants
1318522|NCT02338492|Secondary|Assessment of Post-Surgery Status|Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication|Surgery & Discharge, 7-14, 30, 90, 180, 360 days||||Participants|||Count of Participants
1318507|NCT02339155|Primary|Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups|Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 [Day 1] and Week 2 [Day 15] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment [anti-PA Ab concentration at Week 4]).|Day 29|PP Population.|||Microgram/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1318508|NCT02339038|Primary|Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL).|At least 12 weeks after completion of medication|The analyses included all patients who received at least one dose of ledipasvir-sofosbuvir|||Participants|||Count of Participants
1318509|NCT02338843|Primary|An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP|Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.|Hour 3||||Participants|||Count of Participants
1318510|NCT02338713|Secondary|Number of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE)||Baseline up to 14 days after last dose of study drug (Day 21)|The safety analysis set included all participants who were enrolled and received at least 1 dose of dummy treatment.|||participants|||Number
1318511|NCT02338713|Secondary|Tmax: Time to Reach the Cmax for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK analysis set consisted of all participants who received at least 1 dose of dummy treatment and who had at least 1 measurable serum concentration of calcium in each treatment period.|||hours||Full Range|Median
1318512|NCT02338713|Secondary|AUC(0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set of included participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.|||hr*mmol/L||Geometric Coefficient of Variation|Geometric Mean
1318513|NCT02338713|Secondary|AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Calcium||Days 3 and 6: predose and at multiple time-points (up to 6 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.|||hour*millimoles per litre (hr*mmol/L)||Geometric Coefficient of Variation|Geometric Mean
1318514|NCT02338713|Secondary|Cmax: Maximum Observed Serum Concentration for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.|||millimoles per litre(mmol/L)||Geometric Coefficient of Variation|Geometric Mean
1318515|NCT02338713|Secondary|(Ca^2+ Ae24): Amount of Calcium Excreted in Urine From Time 0 to 24 Hours Post-dose|Ca2+ Ae0-24 was calculated as the urine volume of the urine collected from 0 to 24 hours multiplied by the calcium concentration measured in urine.|Days 3 and 6: pre-dose and at multiple time-points (upto 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period.|||mmol||Geometric Coefficient of Variation|Geometric Mean
1318516|NCT02338713|Secondary|PTH AUC (0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours for Parathyroid Hormone|The PTH AUC(0-24) is a measure of the area under the serum concentration-time curve from 0 to 24 hours of parathyroid hormone.|Days 3 and 6: pre-dose and at multiple time-points (up to 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the calcichew D3 reporting group|The PD serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1318517|NCT02338713|Primary|(Ca^2+ Ae6): Amount of Calcium Excreted in Urine From Time 0 to 6 Hours Post-dose|Ca^2+ Ae6 was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.|Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The pharmacokinetic(PK) urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period.|||millimoles (mmol)||Geometric Coefficient of Variation|Geometric Mean
1318518|NCT02338713|Primary|PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone|The PTH AUC(0-6) is a measure of the area under the serum concentration-time curve from 0 to 6 hours of parathyroid hormone.|Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The Pharmacodynamic(PD) serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period.|||hour*picogram per milliliter (hr*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1318519|NCT02338492|Secondary|Length of Hospital Stay|Length of hospital stay (from day of procedure to day of discharge)|From day of procedure until the day of hospital discharge (up to 36 days)||||Days||Standard Deviation|Mean
1318523|NCT02338492|Secondary|MSTS Upper Extremity Functional Outcome|Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.|90, 180, 360 days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||units on a scale||Standard Deviation|Mean
1318524|NCT02338492|Secondary|Activities of Daily Living Score Through All Follow-up Intervals|Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning.|Baseline, 90, 180 and 360 days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||units on a scale||Standard Deviation|Mean
1318525|NCT02338492|Secondary|Duration of Index Procedure|Duration of index procedure (hours)|1 Day||||hours||Standard Deviation|Mean
1318526|NCT02338492|Secondary|Pain at Palpation|Pain on palpation and clinical significance|90, 180 and 360 days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||Participants|||Count of Participants
1318527|NCT02338492|Primary|Summary of Clinical Safety Success|No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation|Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360||||Participants|||Count of Participants
1318528|NCT02338492|Primary|Change in Function|Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.|Baseline and 90 days|Subjects who had 90 Day data|||units on a scale||Standard Error|Least Squares Mean
1318529|NCT02338492|Primary|Change in Pain|Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).|Baseline and 90 days|Number of subjects who had a Day 90 visit|||units on a scale||Standard Error|Least Squares Mean
1318530|NCT02338336|Primary|Incidence of Zero Lesion Measurement|Percent of participants with lesion measurement either equal to 0 or greater than 0|6 weeks|ITT|||percentage of participants|||Number
1318531|NCT02338336|Primary|Lesion Assessment|Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data|6 weeks|Intent-to-treat|||millimeters||Standard Deviation|Mean
1318532|NCT02338076|Secondary|T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.|t-cell infiltrate in occluded skin versus occluded with petrolatum skin compared with normal skin ( healthy/not occluded skin)|3 days||||cells per micrometer squared||Standard Deviation|Mean
1318533|NCT02338076|Secondary|Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.|skin thickness difference between occluded skin biopsy versus occluded with petrolatum skin biopsy compared with normal skin biopsy was examined|3 days||||micrometer||Standard Deviation|Mean
1318534|NCT02338076|Primary|Measurement of Innate Immune Genes (IL6, IL8, and IL1B) in Skin Biopsy Samples With Petrolatum Occlusion, Normal Skin and Occlusion Without Petrolatum to See if There is Any Difference in Expression||3 days||||log of copy number||95% Confidence Interval|Mean
1318535|NCT02338076|Primary|Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.|The levels of expression of antimicrobial peptides (S100A8, S100A9, CCL20, PI3, lipocalin , human β-defensin 2 will be measured in skin biopsy samples with petrolatum occlusion, normal skin and occlusion without petrolatum to see if there is any difference in expression Please note- There is only 1 arm with 3 measures - for example, subject 1 had 3 biopsies and the outcome measure S100A8, S100A9, PI3, LIPOCALCIN, HUMAN B DEFENSIN were tested in all 3 biopsies. This is reported as the log of the number of copies. HUMAN B DEFENSIN and CCL20 was not collected. S100A7 and S100A12 were added to the analysis.|3 days||||log of copy number||95% Confidence Interval|Mean
1318536|NCT02337959|Secondary|Pair Preference Rating|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects|||units on a scale|Participants|Standard Error|Mean
1318537|NCT02337959|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 139 image pairs were included for the reader study. Of the 139 pairs, 122 were cadaver image pairs. Fifty-two (52) of the cadaver image pairs were from pediatric cadavers and seventy (70) pairs were from adult cadavers. A total of seventeen (17) adult live human subject pairs were included in the reader study.|||units on a scale|Participants|Standard Error|Mean
1318538|NCT02337491|Secondary|Overall Radiographic Response (ORR)|ORR was established based on Response Assessment in Neuro-Oncology (RANO) criteria. RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non-enhancing lesions, and stable or improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR, PR or PD.|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles (each cycle=42 days) was a mean (SD) of 4.5 (4.4) for Cohort A and 2.5 (2.7) for Cohort B.|The analysis dataset is comprised of all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
1318539|NCT02337491|Secondary|Overall Survival (OS)|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 25 months for each cohort.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
1318540|NCT02337491|Secondary|Progression-Free Survival (PFS)|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the date of last disease assessment. Per Response Assessment in Neuro-Oncology (RANO) criteria, PD is a >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition.|Disease was assessed radiographically for response every cycle on treatment and every 6 weeks long-term. Median PFS follow-up (months) was 25 for Cohort A and 26 for Cohort B.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
1318541|NCT02337491|Primary|6-Month Progression-Free Survival (PFS6)|"PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry.~Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria. PD is a >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition."|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles (cycle=42 days) was a mean (SD) of 4.5 (4.4) for Cohort A and 2.5 (2.7) for Cohort B. Assessment at week 72/cycle 12 pertains to the 6-month PFS.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||95% Confidence Interval|Number
1318542|NCT02337491|Primary|Pembrolizumab Dose Limiting Toxicity (DLT) [Cohort A Safety Lead-In]|A DLT is defined as an adverse event (AE) that (a) is >= grade 3 and related to the pembrolizumab with an attribution of possible, probably or definite, and (b) occurs during and/or begins during the first 42 days of study treatment, and (c) does not meet any of the following exception criteria: grade 3 immune-related AE that downgrades to <= grade 2 within 5 days, or <= grade 1/baseline within 14 days of onset; grade 3 asymptomatic endocrinopathy; grade 3 inflammatory reaction attribution to anti-tumor response; grade 3 pneumonitis, neurologic event, or uveitis that downgrades to <=grade 1 within 3 days; liver transaminase elevation <= 8 times institutional upper limit of normal (ULN); total bilirubin <= 5 times institutional ULN; any pre-existing lab abnormality that deteriorates to grade 3/4 and determine not clinically significant by Investigator, Overall Principal Investigator and Sponsor.|The evaluation for MTD occurred continuously through one cycle of treatment (42 days).|The analysis dataset is comprised of all participants who enrolled in the safety lead-in study.|||participants with DLT|||Number
1318543|NCT02337491|Primary|Pembrolizumab Maximum Tolerated Dose (MTD) [Cohort A Safety Lead-In]|The MTD of pembrolizumab in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1, 15 and 29 of each 42 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various regimens of dosing frequency of pembrolizumab 200 mg IV administered under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the pembrolizumab dose frequency regimen at which fewer than one-third of participants experience a DLT. If de-escalation does not occur per design, then the starting dose is the Recommended Phase II Dose (RP2D).|one cycle/42 days|The analysis dataset is comprised of all participants who enrolled in the safety lead-in study. Only dose level 0 was evaluated and no de-escalation doses were evaluated.|||mg every 3 weeks|||Number
1318544|NCT02337062|Primary|Number of Patients With Complete Response (Protection From PONV)|To assess the efficacy of APD421 at 5 mg in combination with a standard anti-emetic in the prevention of post-operative nausea and vomiting (PONV) in adult, surgical patients at high risk of PONV.|24 hours||||Participants|||Count of Participants
1318545|NCT02336958|Primary|Amount (ml) of Local Anesthetic Supplemented by Surgeon||during the intraoperative period||||ml||95% Confidence Interval|Mean
1318546|NCT02336958|Primary|Number of Patients With Required Supplementation of Local Anesthetic by Surgeon||during the intraoperative period||||participants|||Number
1318547|NCT02336763|Secondary|Disease-specific Survival|Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
1318548|NCT02336763|Secondary|Distant Failure Rates|Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
1318549|NCT02336763|Secondary|Overall Survival||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
1318550|NCT02336763|Secondary|Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4||More than 3 months after study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
1323309|NCT02226198|Secondary|HDL-C (mg/dL)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
1318554|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone|The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.|2 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
1318555|NCT02336607|Secondary|The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of The change of pulse wave velocity at baseline and from at least one visit after randomization.|||m/s||Standard Deviation|Mean
1318556|NCT02336607|Secondary|The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||m/s||Standard Deviation|Mean
1318557|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
1318558|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
1318559|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
1318560|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
1318561|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
1318562|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
1318563|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||Percentage||95% Confidence Interval|Number
1318564|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||Percentage||95% Confidence Interval|Number
1318565|NCT02336607|Primary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.||14 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||Percentage||95% Confidence Interval|Number
1318566|NCT02336594|Secondary|Incidence of Treatment-Emergent Adverse Events||7 weeks.||||Number of Participants|||Number
1318631|NCT02335346|Secondary|Percentage of Participants With Fall Events From Fall Questionnaire|Participants reported the details of their falls. Percentage equals the number of participants with fall events / total in treatment group * 100.|Baseline through Week 50|All enrolled participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1318567|NCT02336594|Secondary|Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine|PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.|Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.||||Percent||Standard Error|Mean
1318568|NCT02336594|Primary|AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|AUC∞ of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1318569|NCT02336594|Primary|AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|AUC last of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1318570|NCT02336594|Primary|Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|Cmax of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng/mL||95% Confidence Interval|Geometric Mean
1318571|NCT02336594|Primary|AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets|AUC∞ of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1318572|NCT02336594|Primary|AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets|AUC last of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1318573|NCT02336594|Primary|Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets|Cmax of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng/mL||95% Confidence Interval|Geometric Mean
1318574|NCT02336594|Primary|Apparent Terminal Half-life (t1/2)|t1/2 of RDEA3170 following various treatments.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||hr||95% Confidence Interval|Geometric Mean
1318575|NCT02336594|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)|AUC∞ of RDEA3170 the fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1318576|NCT02336594|Primary|Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)|AUC last of RDEA3170 in fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1318577|NCT02336594|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of RDEA3170 following various treatments.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||hr||Full Range|Median
1318578|NCT02336594|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax of RDEA3170 in fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng/mL||95% Confidence Interval|Geometric Mean
1318579|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 60 minutes post meal.|60 minutes post-meal||||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
1318580|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 30 minutes post meal.|30 minutes post-meal||||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
1318581|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)|Difference score (trt-control) of blood glucose at 120 minutes post meal.|120 minutes post-meal||||Difference score, trt-control (mg/dL)||Standard Deviation|Mean
1318582|NCT02336438|Secondary|Difference Score: Percent of Time With Elevated Blood Glucose|Percent of time within hyperglycemic blood glucose range (bg>140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg>140 in treatment condition minus % time with bg>140 in control condition.|10 days||||Difference score, trt-control (percent)||Standard Deviation|Mean
1318583|NCT02336438|Secondary|Difference Score: Percent of Time Within Normal Blood Glucose Limits|Percent of time within normal blood glucose limits (bg 70-140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time within normal limits in treatment condition minus % time within normal limits in control condition.|10 days||||Difference score, trt-control (percent)||Standard Deviation|Mean
1318584|NCT02336438|Primary|Difference Score: Percent of Time Spent in Hypoglycemic State|Percent of time within hypoglycemic blood glucose range (bg<70) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg<70 in treatment condition minus % time with bg<70 in control condition.|10 days||||Difference score, trt-control (percent)||Standard Deviation|Mean
1318585|NCT02336425|Secondary|Response to QGE031 Between Atopic Asthma and Non-atopic Asthma||Over 52 weeks (treatment) and 20 weeks (follow up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318586|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318587|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1323310|NCT02226198|Secondary|ApoB (g/L)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||g/L||Standard Deviation|Mean
1318588|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)||Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318589|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318590|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)||Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318591|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318592|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318593|NCT02336425|Secondary|QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318594|NCT02336425|Secondary|QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318595|NCT02336425|Primary|QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
1318596|NCT02336282|Secondary|Oral Trail Making Part B|Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||seconds||Standard Deviation|Mean
1318597|NCT02336282|Secondary|Oral Trail Making Part A|Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||seconds||Standard Deviation|Mean
1318598|NCT02336282|Secondary|Verbal Fluency|Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||raw score||Standard Deviation|Mean
1318599|NCT02336282|Secondary|Digit Span Backward|Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||raw score||Standard Deviation|Mean
1318600|NCT02336282|Secondary|NIH Toolbox Working Memory Function|The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory.|After active and sham interventions administered on day one and day two of the trial||||scores on a scale||Standard Deviation|Mean
1318601|NCT02336282|Secondary|NIH Toolbox Flanker Task|The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function.|After active and sham interventions administered on day one and day two of the trial||||scores on a scale||Standard Deviation|Mean
1318602|NCT02336282|Secondary|NIH Toolbox Card Sort Task|The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function.|After active and sham interventions administered on day one and day two of the trial||||scores on a scale||Standard Deviation|Mean
1318603|NCT02336282|Secondary|Neurocognitive Questionnaire: CCSS-NCQ|"The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges:~NCQ Task Efficiency: 9-27.~NCQ Emotional Regulation: 3-9.~NCQ Organization: 3-9.~NCQ Memory: 4-12."|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||scores on a scale||Standard Deviation|Mean
1318604|NCT02336282|Secondary|Digit Span Forward|Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||raw score||Standard Deviation|Mean
1318605|NCT02336282|Primary|Feasibility of At Home tDCS Intervention|This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10.|5 weeks after participant enrollment|Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25)|||Participants|||Count of Participants
1318606|NCT02336178|Secondary|Percentage of Infusions With Less Than Expected Therapeutic Effects (LETEs) in Prophylaxis Setting|Less than expected therapeutic effect (LETE) in the prophylaxis setting was defined as occurrence of any spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of BeneFIX (which was not used to treat a bleed).|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 dose of prophylaxis BeneFIX treatment during the study. Participants in each arm were not mutually exclusive.|||percentage of infusions|Prophylaxis Infusions|95% Confidence Interval|Number
1318607|NCT02336178|Secondary|Percentage of Infusions With Less Than Expected Therapeutic Effects (LETEs) in On-demand Setting|Less than expected therapeutic effect (LETE) in the on-demand setting was defined as 2 successive “no response” ratings recorded after 2 successive BeneFIX drug infusions, respectively.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||percentage of infusions|Bleeding Episodes|95% Confidence Interval|Number
1318608|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in Recovery Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 recovery infusion with BeneFIX during the study. Participants in each arm were not mutually exclusive.|||IU||Standard Deviation|Mean
1318609|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in Prophylaxis Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 dose of prophylaxis BeneFIX treatment during the study. Participants in each arm were not mutually exclusive.|||IU||Standard Deviation|Mean
1318610|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in On-demand Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||IU||Standard Deviation|Mean
1318611|NCT02336178|Secondary|Number of BeneFIX Infusions to Treat Each New Bleed|The number of BeneFIX infusions administered to treat each new bleed was calculated by adding the on-demand initial treatment and any on-demand follow-up treatments for the same bleed. If there was more than one bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||infusions|Bleeds|Standard Deviation|Mean
1318612|NCT02336178|Secondary|Number of Infusions Resulted in the Following Response to On-demand Treatment of Bleeds: Excellent, Good, Moderate, no Response|Response was assessed using 4-point On-Demand Hemostasis Efficacy Rating Scale. Excellent means definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered; good means definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode, or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered; moderate means probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; no response means no improvement between infusions or during the 24 hour interval following an infusion, or condition worsens. Both first infusions and follow-up infusions were included.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||infusions|Infusions||Number
1318613|NCT02336178|Secondary|Annualized Bleeding Rates (ABRs) in Participants Receiving On-demand Treatment With BeneFIX During Their On-demand Period|For on-demand period, the annualized bleeding rate (ABR) was derived for each participant by the following formula: ABR = number of bleeds in on-demand period / (number of days in on-demand period/365.25). The on-demand period was defined as the entire time of enrollment in the study (ie, from the date of the enrollment visit through the day before the Final/Early Termination visit) except time in any prophylaxis period. The breaks in the prophylaxis period were considered on-demand periods. For an on-demand regimen to have been qualified to have ABR calculated, the sum of its periods needed to be >= 14 days.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received on-demand treatment during on-demand period. Participants in each arm were not mutually exclusive.|||episodes/year||Standard Deviation|Mean
1318614|NCT02336178|Secondary|Number of Spontaneous/Non-traumatic Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX|The prophylaxis infusion time, bleed start time and bleed type (etiology) were used to determine the number of spontaneous, non-traumatic breakthrough bleeds that occurred <=48 hours after a prophylaxis infusion. If there was more than 1 bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence.|Up to 6 months or 50 exposure days whichever occurred first|All participants with any spontaneous/non-traumatic breakthrough bleeds within 48 hours of a prophylaxis dose. Participants in each arm were not mutually exclusive.|||breakthrough bleeds|Prophylaxis Infusions with Bleeds|Standard Deviation|Mean
1318642|NCT02334982|Secondary|Renal Clearance (CLr) for TAK-137|CLr is a measure of apparent clearance of the drug from the urine, calculated as CLr=Ae(0-t)/AUC(0-96).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||liters/hour||Standard Deviation|Mean
1318615|NCT02336178|Secondary|Annualized Bleeding Rates (ABRs) in Participants Receiving Prophylaxis Treatment With BeneFIX During Their Prophylaxis Period|For prophylaxis period, annualized bleeding rate (ABR) was derived for each participant by the following formula: ABR = number of bleeds in prophylaxis period / (number of days in prophylaxis period/365.25). A prophylaxis period was defined as time from first prophylaxis infusion through 6 calendar days after the day of last prophylaxis infusion, or the day of study conclusion visit, whichever was earlier. A break in the prophylaxis period was any period of 28 days or longer in which no prophylaxis infusions were given. For a prophylaxis regimen to have been qualified to have ABR calculated, the sum of its periods needed to be >=14 days.|Up to 6 months or 50 exposure days whichever occurred first|All participants who participated in at least 1 day of a prophylaxis period (ie, had at least 1 prophylaxis dose). Participants in each arm were not mutually exclusive.|||episodes/year||Standard Deviation|Mean
1318616|NCT02336178|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causality with the treatment or usage. A serious adverse event (SAE) was any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both serious and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.|Up to 7 months (28 calendar days after end of 6-month or 50-exposure day study treatment)|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||participants|||Number
1318617|NCT02336178|Primary|Number of Participants With Thrombotic Events|Thrombotic event was defined as any event associated with formation of a blood clot including catheter-associated thrombi and thrombotic complications.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||participants|||Number
1318618|NCT02336178|Primary|Number of Participants With Allergic Reactions|FIX product allergy was defined as a hypersensitivity reaction to a FIX product with symptoms such as hives, urticaria, tightness of chest, wheezing, hypotension, and anaphylaxis based on investigator’s judgments.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||participants|||Number
1318619|NCT02336178|Primary|Percentage of Participants Who Developed Factor IX Inhibitor|Factor IX (FIX) inhibitor development was defined as any Bethesda inhibitor titer greater than the laboratory’s normal range or Bethesda inhibitor titer >=0.6 Bethesda Unit (BU)/mL.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1318620|NCT02335710|Primary|Kinematics During Ramp Down Activity|AR of the femur during ramp down activity|3 months post-operative||||degrees||Standard Deviation|Mean
1318621|NCT02335710|Primary|Kinematics Translations During Ramp Down Activity|AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity|3 months post-operative||||mm||Standard Deviation|Mean
1318622|NCT02335710|Primary|Kinematics During Ramp up Activity|AR of the femur during Ramp Up activity|3 months post-operative||||degrees||Standard Deviation|Mean
1318623|NCT02335710|Primary|Kinematics Translations During Ramp up Activity|AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity|3 months post-operative||||mm||Standard Deviation|Mean
1318624|NCT02335710|Primary|Kinematics During Squat to Stand (S2S) Activity|Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S|3 months post-operative||||degrees||Standard Deviation|Mean
1318625|NCT02335710|Primary|Kinematics Translations During Squat to Stand (S2S) Activity|Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S|3 months post-operative||||mm||Standard Deviation|Mean
1318626|NCT02335710|Primary|Kinematics During Deep Knee Bend (DKB) Activity|Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB|3 months post-operative||||degrees||Standard Deviation|Mean
1318627|NCT02335710|Primary|Kinematics Translations During Deep Knee Bend (DKB) Activity|Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB|3 months post-operative||||mm||Standard Deviation|Mean
1318628|NCT02335502|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.|Baseline and End of Trial Visit|All subjects treated with the Axium implantable neurostimulator who completed their end of trial visit.|||Participants|||Count of Participants
1318629|NCT02335502|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|3, 6 and 12-Months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
1318630|NCT02335489|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|Baseline, 3, 6 and12-Months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
1318687|NCT02334267|Primary|Peridialytic Venous Blood Acetate Concentrations|Quantification of Peridialytic Venous Blood Acetate Concentrations|25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis|Per Protocol Population|||mmol/L||Standard Deviation|Mean
1318632|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score|Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1318633|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument.The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm with scores ranging from -0.111 to 1.0. A higher score indicates better health state.|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1318634|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)|36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-6); social functioning (range: 2-10); bodily pain (range: 2-11); vitality (range: 4-24); mental health (range: 5-30).|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1318635|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 millimeter (mm)(extreme).|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1318636|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)|Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1318637|NCT02335346|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1318638|NCT02335346|Secondary|Patient Global Impression-Improvement (PGI-I) at 50 Weeks|Patient Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1318639|NCT02335346|Primary|Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)|A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.|Baseline through Week 53|All enrolled participants who received at least one dose of study drug.|||Percentage of participants|||Number
1318640|NCT02335216|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|3, 6 and 12-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||Participants|||Count of Participants
1318641|NCT02335216|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|Baseline, 3, 6 and 12 Months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
1318643|NCT02334982|Secondary|Fraction of TAK-137 Excreted in Urine (Fe)|Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||percent excreted||Standard Deviation|Mean
1318644|NCT02334982|Secondary|Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t])|Total amount of drug excreted in urine from time 0 to time t, calculated as Sum (Cu*Vu), where Cu is the concentration of drug excreted in urine and Vu is the volume of urine excreted.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||mg||Standard Deviation|Mean
1318645|NCT02334982|Secondary|Apparent Volume of Distribution (Vz/F) for TAK-137_101|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||liters||Standard Deviation|Mean
1318646|NCT02334982|Secondary|Apparent Clearance (CL/F) for TAK-137_101|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-inf), expressed in liters per hour (L/hr).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||liters/hour||Standard Deviation|Mean
1318647|NCT02334982|Secondary|Terminal Elimination Half-life (T1/2) for TAK-137_101|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||hours||Standard Deviation|Mean
1318648|NCT02334982|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1318649|NCT02334982|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
1318650|NCT02334982|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||hours||Full Range|Median
1318651|NCT02334982|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||ng/mL||Standard Deviation|Mean
1318652|NCT02334982|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|Day 1 to 14 days after the last dose of study medication|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.|||percentage of participants|||Number
1318653|NCT02334982|Primary|Percentage of Participants With Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|Day 1 to 14 days after the last dose of study medication (Up to 30 Days)|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.|||percentage of participants|||Number
1318654|NCT02334982|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to 14 days after the last dose of study medication(Up to 30 days)|Safety population included all participants who received at least one dose of study medication. 8 of the 47 enrolled participants participated in Cohort 4 fed.|||percentage of participants|||Number
1318655|NCT02334813|Primary|Remission Duration|Percentage of patients in ongoing remission at 6 months|6 months||||Participants|||Count of Participants
1318656|NCT02334800|Secondary|Number of Participants With Concomitant Medications|Treatments taken after the first dose of study treatment were documented as concomitant treatments.|From screening through and including Day 6 for Cohort 1, and from screening through and including Day 9 for Cohorts 2, 3, and 4.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
1318688|NCT02334267|Primary|Peridialytic Arterialized Blood Acetate Concentrations|Quantification of Peridialytic Arterialized Blood Acetate Concentrations|Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis|Per Protocol Population|||mmol/L||Standard Deviation|Mean
1318689|NCT02334267|Primary|Peridialytic Venous Blood Bicarbonate Concentrations|Quantification of Peridialytic Venous Blood Bicarbonate Concentrations|25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis|Per Protocol Population|||mEq/l||Standard Deviation|Mean
1318657|NCT02334800|Secondary|Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)|Maximum increases from baseline for post baseline electrocardiogram values were summarized for PR interval, QRS complex, QT interval, QTcB (QT interval calculated using Bazett’s correction factor), and QTcF (QT interval calculated using Fridericia’s correction factor). The number of participants with maximum increase from baseline for post baseline electrocardiogram values meeting the following criteria was reported: (1) percent change of PR interval >=25/50%; (2) percent change of QRS complex >=50%; (3) QT interval 30 to <60 msec; (4) QT interval >= 60 msec; (5) QTcB 30 to <60 msec; (6) QTcB >= 60 msec; (7) QTcF 30 to <60 msec; and (8) QTcF >= 60 msec. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|||paticipant|||Number
1318658|NCT02334800|Secondary|Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)|Maximum absolute values of post baseline electrocardiogram were summarized for PR interval, QRS complex, QT interval, QTcB (QT interval calculated using Bazett’s correction factor), and QTcF (QT interval calculated using Fridericia’s correction factor). The number of participants with maximum absolute values of post baseline electrocardiogram meeting the following criteria was reported: (1) PR interval >=300 msec; (2) QRS complex >=140 msec; (3) QT interval 450 to <480 msec; (4) QT interval 480 to <500 msec; (5) QT interval >= 500 msec; (6) QTcB 450 to <480 msec; (7) QTcB 480 to <500 msec; (8) QTcB >= 500 msec; (9) QTcF 450 to <480 msec; (10) QTcF 480 to <500 msec; and (11) QTcF >=500 msec. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|||participant|||Number
1318659|NCT02334800|Secondary|Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria|The number of participants with post baseline vital signs values meeting the following criteria was reported: A. absolute value of supine systolic blood pressure less than (<) 90 mmHg; B. absolute value of diastolic blood pressure <50 mmHg; C. absolute value of supine pulse rate <40 bmp; D. absolute value of supine pulse rate larger than (>) 120 bmp; E. maximum increase from baseline in supine systolic blood pressure larger than and equal to (>=) 30 mmHg; F. maximum increase from baseline in supine diastolic blood pressure >=20 mmHg; G. maximum decrease from baseline in supine systolic blood pressure >=30 mmHg; and H. maximum decrease from baseline in supine diastolic blood pressure >=20 mmHg.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
1318660|NCT02334800|Secondary|Number of Participants With Physical Examination Test Abnormalities (Change From Prior Visit)|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
1318661|NCT02334800|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|Laboratory tests included tests that were performed under the categories of hematology, chemistry, urinalysis, other, and additional tests needed for Hy’s law.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, inclusive of baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participants|||Number
1318662|NCT02334800|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events|A serious adverse event is any untoward medical occurrence at any dose that resulted in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; or results in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity are counted as treatment emergent. Relatedness to palbociclib is assessed by the investigator (Yes/No).|The active reporting period for serious adverse events began from the time that the participant provided informed consent through and including 28 calendar days after the last administration of palbociclib.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
1318663|NCT02334800|Secondary|Number of Participants With Treatment Emergent Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity are counted as treatment emergent. Relatedness to palbociclib is assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Adverse events were recorded on the Case Report Form from the time the participant had taken at least 1 dose of palbociclib through the participant’s last visit.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
1318690|NCT02334267|Primary|Peridialytic Arterialized Blood Bicarbonate Concentrations|Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations|Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis|Per Protocol Population|||mEq/l||Standard Deviation|Mean
1318821|NCT02329964|Secondary|Time to Eye Opening|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.|from end of surgery to opening of the eyes to verbal commands||||seconds||Inter-Quartile Range|Median
1318664|NCT02334800|Secondary|Unbound Vz/F (Vz,u/F)|Vz,u/F is unbound Vz/F, where Vz/F is apparent volume of distribution after oral dose. It is obtained by dose/(AUCinf,u*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, and AUCinf,u is unbound AUCinf (area under the concentration-time curve from time 0 extrapolated to infinite time).|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||L||Geometric Coefficient of Variation|Geometric Mean
1318665|NCT02334800|Secondary|Apparent Volunm of Distribution After Oral Dose (Vz/F)|Vz/F is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. It is influenced by the fraction absorbed. It is obtained by dose/(AUCinf•kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, and AUCinf is the area under the concentration-time curve from time 0 extrapolated to infinite time.|pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
1318666|NCT02334800|Secondary|Time for Cmax (Tmax)|Tmax is time for maximum plasma concentration. It is observed directly from data as time of first occurrence of maximum plasma concentration.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics concentration population was defined as all participants enrolled and treated who had at least 1 palbociclib concentration|||hr||Full Range|Median
1318667|NCT02334800|Secondary|Terminal Half-Life (t1/2)|T1/2 is terminal half-life. It is obtained by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||hour (hr)||Standard Deviation|Mean
1318668|NCT02334800|Secondary|Fraction of Unbound Drug in Plasma (fu)|Fu is the fraction of unbound drug in plasma. It is obtained from measurement of protein binding.|Eight (8) hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ratio||Standard Deviation|Mean
1318669|NCT02334800|Secondary|Unbound Cmax (Cmax,u)|Cmax,u is unbound Cmax, where Cmax is maximum plasma concentration. It is obtained by fu*Cmax, where fu is fraction of unbound drug in plasma.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1318670|NCT02334800|Secondary|Unbound CL/F (CLu/F)|CLu/F is unbound CL/F, where CL/F is apparent clearance after oral dose. It is obtained by dose/AUCinf,u, where AUCinf,u is unbound AUCinf (area under the concentration-time curve from time 0 extrapolated to infinite time).|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1318671|NCT02334800|Secondary|Apparent Clearance After Oral Dose(CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance is obtained by dose/AUCinf, where AUCinf is the area under the concentration-time curve from time 0 extrapolated to infinite time.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1318672|NCT02334800|Secondary|Unbound AUClast (AUClast,u)|AUClast,u is unbound AUClast, where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. It is obtained by fu*AUClast, where fu is the fraction of unbound drug in plasma.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1318673|NCT02334800|Secondary|Area Under the Concentration‑Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)|AUClast is area under the plasma concentration time curve from time 0 to time of last quantifiable concentration. It is obtained from linear/log trapezoidal method.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1318674|NCT02334800|Secondary|Unbound AUCinf (AUCinf,u)|AUCinf,u is unbound AUCinf, where AUCinf is area under the concentration-time curve from time 0 extrapolated to infinite time. It is obtained by fu*AUCinf, where fu is the fraction of unbound drug in plasma.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1318675|NCT02334800|Primary|Maximum Plasma Concentration (Cmax)|Cmax is maximum plasma concentration. It is observed directly from data.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics concentration population was defined as all participants enrolled and treated who had at least 1 palbociclib concentration.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1318676|NCT02334800|Primary|Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)|AUCinf is area under the plasma concentration time curve from time 0 extrapolated infinite time. It is calculated as AUClast + (Clast/kel), where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1318677|NCT02334787|Secondary|AUC12h of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14||||ng･h/mL||Standard Deviation|Mean
1318678|NCT02334787|Secondary|AUC12h of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs||||ng･h/mL||Standard Deviation|Mean
1318679|NCT02334787|Primary|Cmax of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14||||ng/mL||Standard Deviation|Mean
1318680|NCT02334787|Primary|Cmax of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the Cmax of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr||||ng/mL||Standard Deviation|Mean
1318681|NCT02334527|Secondary|Number of Participants With Adverse Events|Characterize the safety profile of palbociclib in patients with metastatic UC after first-line chemotherapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|30 Days||||Participants|||Count of Participants
1318682|NCT02334527|Secondary|Response Rate (RR) - Total Number of Patients With Complete Response (CR) and/or Partial Response (PR)|Estimate response rate (RR) in patients with metastatic UC who have progressed after first-line chemotherapy. Response rate will be the number of patients with complete response and/or partial response. Response will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 Months||||Participants|||Count of Participants
1318683|NCT02334527|Secondary|Overall Survival (OS)|Overall survival is defined as the time from day 1 of treatment until death as a result of any cause.|Patients will be followed for up to 5 years after removal from study therapy or death, whichever occurs first.||||Months||95% Confidence Interval|Median
1318684|NCT02334527|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from D1 of treatment until progression or death as a result of any cause. Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|4 Months||||Months||95% Confidence Interval|Median
1318685|NCT02334527|Primary|Progression Free Survival|Estimate progression free survival (PFS) at 4 months in patients with metastatic urothelial cancer (UC) who have progressed after first-line chemotherapy. PFS is defined as the percent of patients who are alive and free from progression at 4 months.|4 Months||||Participants|||Count of Participants
1318686|NCT02334384|Primary|Number of Side-effects|Evaluate for evidence of side-effects from Antimicrobial TheraGauze packing of skin abscess wounds compared with standard of care (i.e. cotton wick or iodoform wick). Tests for statistical significance will be made for multiple potential side-effects including: 1) erythema around the wound packing, 2) increased pain at the wound site, 3) increased tenderness around the wound 4) increased discharge from the wound, 4) new rash, and 5) fever.|1 week||||Participants|||Count of Participants
1318691|NCT02333045|Secondary|Steady-state Area Under the Female Genital Tract Concentration-time Curve of Study Drug|Study drug concentrations will be measured from female genital tract.|7 days|Data were not collected at each visit as some participants declined providing samples. Due to the small number of observations, study drug concentrations were not determined for the samples provided.||||||
1318692|NCT02333045|Secondary|Steady-state Area Under the Plasma Concentration-time Curve of Study Drug|Study drug concentrations will be measured from blood.|7 days|Data were not collected at each visit as some participants declined providing samples. Due to the small number of observations, study drug concentrations were not determined for the samples provided.||||||
1318693|NCT02333045|Primary|Count of Total Cells Obtained From Cervicovaginal Lavage Samples|The count of CCR5+CD4+ T cells in the genital tract, before participants began study treatment, after 7 days of treatment, and during the post-treatment drug elimination period. The precise role of CCR5+CD4+ T cells in the female genital tract is unknown, however, higher cell counts may suggest the potential for more HIV target cells in the genital tract.|Baseline, Day 7, Day 14, Day 21|The analysis includes all available data collected during each study visit. Not all participants provided a sample at every study visit.|||cells||Standard Deviation|Mean
1318694|NCT02332902|Other Pre-specified|Determine How Orally Administered Everolimus Effects mTOR Signaling in NF-1 Tissues|Quantification via immunohistochemical staining of PTEN, pS6, p4EBP-1, TSC2, mTOR, NF-1, pAKT, VEGF-A and IGF-IR expression in biopsied neurofibroma tissue samples.|6 months|||||||
1318695|NCT02332902|Secondary|Number of Participants With Grade 3-4 Adverse Events|Determination if orally administered Afinitor is safe in patients a indicated by lack of Grade 3-4 adverse events during the trial period.|6 months||||Participants|||Count of Participants
1318696|NCT02332902|Primary|3D Photographic Measurement of Surface Volume|Photographs of selected lesions to measure surface volume.|6 months||||mm^3||95% Confidence Interval|Mean
1318697|NCT02332889|Primary|Tolerability (Number of Participants Without Adverse Events)||20 weeks||||Participants|||Count of Participants
1318698|NCT02332876|Primary|National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test|Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1318699|NCT02332824|Other Pre-specified|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Week 14|Safety analysis set included all participants who received at least one dose of the study drug for the treatment period.|||Participants|||Count of Participants
1318700|NCT02332824|Secondary|Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12)|Progression rate is defined as percentage of participants who have UACR ≥300 mg/gCr and whose UACR increased by ≥30% from the value at the end of the pre-treatment period [Week 0]. Meanwhile, the definition of transition to overt nephropathy also includes the case that UACR decreased to <300 mg/gCr after the transition to overt nephropathy.|Week 12|The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1318701|NCT02332824|Secondary|Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12)|Remission rate is defined as percentage of participants who have UACR <30 mg/gCr and whose UACR decreased by ≥30% from the value at the end of the pre-treatment period (Week 0).|Week 12|The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1318702|NCT02332824|Secondary|Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point|The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR. Reported data is geometric mean ratio of UACR at each assessment point relative to Baseline.|Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment|The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at particular timepoint.|||mg/gCr||95% Confidence Interval|Geometric Mean
1318703|NCT02332824|Primary|Change From End of Pre-treatment Period (Week 0) in Log-transformed Urine Albumin/Creatinine Ratio (UACR) at the End of Treatment Period (Week 12)|The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR.|Week 0 and Week 12|Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||log (mg/gCr)||95% Confidence Interval|Least Squares Mean
1318704|NCT02332798|Primary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318705|NCT02332798|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318706|NCT02332798|Primary|Number of Participants With Abnormalities in Physical Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318707|NCT02332798|Primary|Number of Participants With Abnormalities in Neurological Examination|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318708|NCT02332798|Primary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, and QTc using Fridericia’s formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and and QTcF >=450 to <480, 480 to <500 and >=500 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318709|NCT02332798|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<) 40 or greater than (>) 120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318710|NCT02332798|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were reported: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, phosphorus, cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), bicarbonate, uric acid, albumin, and total protein); urinalysis (color, appearance, specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
1318711|NCT02332798|Primary|Peak-to-Trough Ratio at Steady State (PTR)|PTR was calculated as Cmax divided by Cmin (that is defined as lowest concentration observed during the dosing interval). PTR steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1318712|NCT02332798|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax) (Steady State)|Accumulation ratio based on Cmax was calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose. Rac, Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1318713|NCT02332798|Primary|Observed Accumulation Ratio (Rac) (Steady State)|Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1). Rac steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 (ie. X = 14) were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1318776|NCT02331589|Secondary|Pro-inflammatory Cytokine|tumor necrosis factor-alpha, interleukin-6|3 weeks of KRG||||pg/mL||Standard Deviation|Mean
1318822|NCT02329964|Secondary|Time to First Spontaneous Breath|time from end of surgery to first spontaneous breaths|from end of surgery to first spontaneous breaths||||seconds||Inter-Quartile Range|Median
1318714|NCT02332798|Primary|Terminal Half-Life (t1/2) (Steady State)|Terminal half-life is the time measured for the plasma concentration to decrease by one half. t1/2 steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||hours||Standard Deviation|Mean
1318715|NCT02332798|Primary|Apparent Volume of Distribution (Vz/F) (Steady State)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
1318716|NCT02332798|Primary|Apparent Oral Clearance (CL/F) (Steady State)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1318717|NCT02332798|Primary|AUCτ (Steady State)|AUCτ steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1318718|NCT02332798|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1318719|NCT02332798|Primary|Tmax (Steady State)|Tmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||hours||Full Range|Median
1318720|NCT02332798|Primary|Time for Cmax (Tmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||hours||Full Range|Median
1318721|NCT02332798|Primary|Cmax (Steady State)|Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose)|The PK concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1318722|NCT02332798|Primary|Maximum Observed Plasma Concentration (Cmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The pharmacokinetic (PK) concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1318723|NCT02332720|Secondary|Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24)|SVR24 is defined as HCV RNA <LLOQ of 15 IU/mL 24 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.|Up to 40 weeks|Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.|||Percentage of participants||95% Confidence Interval|Number
1318724|NCT02332720|Primary|Number of Participants Who Had Study Drug Discontinued Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.|Up to 16 weeks|All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.|||Participants|||Count of Participants
1318823|NCT02329964|Primary|Recovery of T1 to 10%|we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes||||seconds||Inter-Quartile Range|Median
1318824|NCT02329964|Other Pre-specified|Anesthesia Time|time from propofol injection to extubation|from the anesthesia start to end||||minutes||Standard Deviation|Mean
1318725|NCT02332720|Primary|Number of Participants Experiencing an Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.|Up to 40 weeks|All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.|||Participants|||Count of Participants
1318726|NCT02332720|Primary|Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (<LLOQ, 15 IU/mL) 12 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.|Up to 20 weeks (Part A), up to 28 weeks (Part B)|Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.|||Percentage of participants||95% Confidence Interval|Number
1318727|NCT02332707|Primary|Percentage of Participants Discontinuing From Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|All randomized participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
1318728|NCT02332707|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)|The percentage of participants with HCV RNA < LLoQ 24 weeks after completing treatment (i.e., SVR24) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.|Up to 40 weeks|All randomized participants who received at least 1 dose of study drug and had SVR24 results available are included.|||Percentage of Participants||95% Confidence Interval|Number
1318729|NCT02332707|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks|All randomized participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
1318730|NCT02332707|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)|The percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) < Lower Limit of Quantification (LLoQ) 12 weeks after completing treatment (i.e., SVR12) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.|Up to 28 weeks|All randomized participants who received at least 1 dose of study drug and had SVR12 results available are included.|||Percentage of Participants||95% Confidence Interval|Number
1318731|NCT02332590|Secondary|Measurement of Anti-Drug Antibody (ADA) Levels||Over time, maximum to Week 306|||||||
1318732|NCT02332590|Secondary|Clinically Significant Changes in Vital Signs||Over time, maximum to Week 306|||||||
1318733|NCT02332590|Secondary|Clinically Significant Changes in ECG||Over time, maximum to Week 306|||||||
1318734|NCT02332590|Secondary|Clinically Significant Changes in Laboratory Values: Hematology, Clinical Chemistry, and Urinalysis||Over time, maximum to Week 306|||||||
1318735|NCT02332590|Secondary|Number of Participants With Adverse Events||Over time, maximum to Week 306|||||||
1318736|NCT02332590|Secondary|Sarilumab Exposure Assessed by Trough Serum Sarilumab Concentrations||Over time, maximum to Week 306|||||||
1318737|NCT02332590|Secondary|Change From Baseline in Individual ACR Component- ESR Level at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). The ESR is a blood test that can reveal inflammatory activity. Inflammation can cause the cells to clump together. The farther the red blood cells have descended, the greater the inflammatory response. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with ESR assessment both at baseline and Week 24.|||mm/hr||Standard Error|Least Squares Mean
1318738|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - CRP Level at Week 24|"ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). An elevated CRP level was considered a non-specific marker for RA. A reduction level indicates improvement. LS mean and SE at Week 24 were obtained using MMRM approach."|Baseline, Week 24|ITT population. Number of participants analyzed = participants with CRP assessment both at baseline and Week 24.|||mg/L||Standard Error|Least Squares Mean
1318739|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). Physician global VAS & participant global VAS was done on 100 mm horizontal anchored VAS, ranging from 0 “no arthritis activity” to 100 “maximal arthritis activity” and Pain VAS on 100 mm VAS, ranging from 0 “no pain” to 100 “worst pain”. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with individual ACR components assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.|||mm||Standard Error|Least Squares Mean
1318797|NCT02331368|Primary|The Number of Patients That Achieve Complete Response|The primary efficacy endpoint is complete response rate. The complete response rate was estimated by the observed proportion of complete responders at day 180. Complete response (CR) was defined as negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow and negative bone marrow flow cytometry.|180 days post-transplant|32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation.|||Participants|||Count of Participants
1318740|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - TJC and SJC at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with TJC and SJC assessment both at baseline and Week 24.|||joints||Standard Error|Least Squares Mean
1318741|NCT02332590|Secondary|Change From Baseline in Morning Stiffness VAS at Week 24|RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with morning stiffness VAS assessment both at baseline and Week 24.|||mm||Standard Error|Least Squares Mean
1318742|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318743|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed =participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
1318744|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
1318745|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
1318746|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
1318747|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Arthritis Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT Population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318798|NCT02331108|Secondary|Measurement of Blood Pressure|Blood pressure decrease after intravenous anesthetic induction|intraoperative|Percentage of patients whose blood pressure decreased after propofol administration|||percentage of patients|||Number
1318799|NCT02331108|Primary|Temperature Below 36.0 Degrees C|Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia|Intraoperative|Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia|||Percentage|||Number
1318748|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
1318749|NCT02332590|Secondary|Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
1318750|NCT02332590|Secondary|Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) at Week 24|RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well-being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10 that corresponds to the 7 domains. The values for each of these domains are weighed by participant assessment of relative importance and combined in a single and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with RAID assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318751|NCT02332590|Secondary|Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24|EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. EQ-5D specifically included to address concerns regarding the health economic impact of RA. EQ-5D-3L comprises of 5 questions on mobility, self-care, pain/discomfort, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional 3-level systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-3L-VAS records the participant’s self-rated health on a vertical VAS that allows the participants to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with EQ-5D-3L score assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1318752|NCT02332590|Secondary|Change From Baseline in CDAI at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant’s global disease activity (in cm), and physician’s global assessment of disease VAS (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. LS means and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with CDAI assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318753|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Remission (CDAI ≤2.8) at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant’s global disease activity (in cm), and physician’s global assessment (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.|||percentage of participants|||Number
1318754|NCT02332590|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28-ESR < 3.2) at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.|||percentage of participants|||Number
1318755|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP <2.6) at Week 24|DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by hs-CRP in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.|||percentage of participants|||Number
1318800|NCT02331108|Primary|Measurement of Core Temperature|Core temperature at 15 minute intervals|intraoperative||||degree C||Standard Deviation|Mean
1318825|NCT02329964|Other Pre-specified|Length of Stay in te Operating Room|LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.|time from in to out of the operating room||||minutes||Standard Deviation|Mean
1318756|NCT02332590|Secondary|Change From Baseline in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP Score) at Week 24|DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with DAS28-CRP score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318757|NCT02332590|Secondary|Change From Baseline in SF-36 - Mental Health Component Summary Score at Week 24|SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures HRQL in the last 4 weeks covering 2 summary measures: PCS and MCS. PCS with 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 - mental health component summary score assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318758|NCT02332590|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|The FACIT-F is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score range from 0 to 52, where higher score corresponds to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with FACIT-F score assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318759|NCT02332590|Secondary|Change From Baseline in Short-Form-36 (SF-36) - Physical Component Summary (PCS) Score at Week 24|SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures health-related quality of life (HRQL) in the last 4 weeks covering 2 summary measures: PCS and mental component summary (MCS). PCS with 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a sub-scale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 PCS score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318760|NCT02332590|Secondary|Change From Baseline in HAQ-DI at Week 24|Physical function was assessed by HAQ-DI. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with HAQ-DI assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318761|NCT02332590|Secondary|Percentage of Participants Achieving ACR20 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better health] - 3 [worst health]). ACR20 was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.|||percentage of participants|||Number
1318762|NCT02332590|Secondary|Percentage of Participants Achieving ACR70 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better health] - 3 [worst health]). ACR70 was defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.|||percentage of participants|||Number
1318818|NCT02330055|Secondary|Minimal & Mean SpO2|Basic pulseoximetry in the first night after delivery|48 hours after delivery||||percentage of hemoglobin in the blood||Inter-Quartile Range|Median
1318826|NCT02329964|Secondary|Time to Extubation|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation|from the end of surgery to extubate a tracheal tube||||seconds||Inter-Quartile Range|Median
1318763|NCT02332590|Secondary|Percentage of Participants Achieving ACR50 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (C-reactive protein [CRP] level); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by Health Assessment Questionnaire - Disability Index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.|||percentage of participants|||Number
1318764|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-ESR <2.6) at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants who discontinued treatment prior to Week 24 were analyzed as non-responders.|Week 24|ITT Population.|||percentage of participants|||Number
1318765|NCT02332590|Primary|Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the American College of Rheumatology (ACR) rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS); Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Least square (LS) mean and standard error (SE) at Week 24 were obtained using Mixed-effect model with repeated measures (MMRM) approach.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants. Number of participants analyzed = participants with DAS28-ESR assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1318766|NCT02332239|Secondary|Acceptability/Feasibility: Participant Satisfaction|The Customer Satisfaction Questionnaire (CSQ-8) developed by Larsen et al. (1979) is an 8-item survey where each item is scored 1 (poor) to 4 (excellent). It is scored by summing the individual item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.|8 weeks post-enrollment (close of intervention)||||units on a scale||Standard Deviation|Mean
1318767|NCT02332239|Secondary|Acceptability/Feasibility: Engagement of Intervention Group|Among the intervention group, how many participants responded to at least one of the daily text message queries, and how many requested on-demand support text-messages.|Enrollment to 16 weeks post-enrollment||||Participants|||Count of Participants
1318768|NCT02332239|Secondary|Acceptability/Feasibility: Follow Up Rate|Retention Rate: % of consented participants who completed follow up|8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)||||Participants|||Count of Participants
1318769|NCT02332239|Primary|Change in Peer Violence Involvement|The Physical Assault subscale of the Conflict Tactics Scale (CTS-2), developed by Straus et al. (1996), was used to analyze changes in past-two-month peer violence in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. There are 14 items that measure violent behavior, each scored based on how frequently the participant has experienced the behavior (0=never to 6=20+ times). Score is summed, so the minimum score possible is 14*0=0 (lowest level of violence) and the maximum score possible is 14*6=84 (highest level of violence).|Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)|Stratified by higher baseline violence (CTS score >=4)|||units on a scale||Full Range|Median
1318770|NCT02332239|Primary|Change in Depressive Symptoms|Becks Depression Inventory (BDI-2): To analyze changes in past-two-week depressive symptoms in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. The Beck Depression Inventory (BDI-2) is a 1996 revision of the BDI, developed in response to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV, which changed many of the diagnostic criteria for Major Depressive Disorder. Participants were asked to rate how they have been feeling for the past two weeks. It contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.|Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)|"Stratified by baseline moderate depressive symptoms (BDI>=20)."|||units on a scale||Standard Deviation|Mean
1318771|NCT02331940|Secondary|Hospitalization Rate|Number of patients needed hospitalization|6 months after treatment initiation||||participants|||Number
1318772|NCT02331940|Secondary|Sleepiness|Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness)|6 months after treatment initiation||||units on a scale||Standard Deviation|Mean
1318773|NCT02331940|Primary|Sleep Quality|"Sleep quality, meaning the architecture of sleep (amount of the different sleep stages across the sleep episode),consists of sleep efficiency (%) (total sleep time - TST divided by the total time in bed and multiplied by 100), REM (%TST) (rapid eye movement sleep divided by TST and multiplied by 100) and NREM (%TST) (non-rapid eye movement sleep divided by TST and multiplied by 100).~NORMAL RANGES Sleep efficiency: Normal is approximately 85 to 90% or higher. NREM (%TST): 75-80% REM (%TST) normally occupies about 20-25% of sleep time."|6 months after treatment initiation||||percentage of time||Standard Deviation|Mean
1318774|NCT02331940|Primary|Sleeping Oxygen Saturation|Mean sleeping oxygen saturation (%)|6 months after treatment initiation||||percentage of Oxygen Saturation||Standard Deviation|Mean
1318775|NCT02331589|Secondary|Adiponectin|enzyme-linked immunosorbent assay|3 weeks of KRG||||pg/mL||Standard Deviation|Mean
1318777|NCT02331589|Secondary|Fatigue as Measured by KRUPP’s Fatigue Severity Scale|"KRUPP’s fatigue severity scale.~The survey has nine questions as following:~my motivation is lower, when I am fatigued~exercise brings on my fatigue~I am easily fatigued~fatigue interferes with my physical functioning~fatigue causes frequent problems for me~my fatigue prevents sustained physical functioning~fatigue interferes with carrying out certain duties and responsibilities~fatigue is among my 3 most disabling symptoms~fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree).~Scores range from 9 to 63, with higher scores indicating higher fatigue"|3 weeks of KRG||||scores on a scale||Standard Deviation|Mean
1318778|NCT02331589|Primary|Liver Enzymes|aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase|3 weeks of KRG||||U/L||Standard Deviation|Mean
1318779|NCT02331446|Primary|Change in Superoxide Dismutase Activity||Weeks 0, 6 and 12||||U/mg protein||Standard Deviation|Mean
1318780|NCT02331446|Other Pre-specified|Chronic Use of Medication|Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||participants|||Number
1318781|NCT02331446|Other Pre-specified|Age|The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||years||Inter-Quartile Range|Median
1318782|NCT02331446|Other Pre-specified|Household Income|Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||US$||Inter-Quartile Range|Median
1318783|NCT02331446|Other Pre-specified|Educational Level|Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||participants|||Number
1318784|NCT02331446|Other Pre-specified|Change in Calories Intake|Measured by a 24-hour food recall and quantified in calories|Weeks 0 and 12||||cal||Standard Deviation|Mean
1318785|NCT02331446|Other Pre-specified|Change in Minutes Per Week of Physical Activity Out of Intervention|Measured by the commuting and leisure sections of the International Physical Activity Questionnaire|Week 0 and 12||||minutes per week||Inter-Quartile Range|Median
1318786|NCT02331446|Other Pre-specified|Change in Body Mass Index||Weeks 0 and 12||||kg/m²||Inter-Quartile Range|Median
1318787|NCT02331446|Secondary|Change in Handgrip Strength|Measured using a handgrip dynamometer and quantified in kilogram-force|Weeks 0 and 12||||kgf||Standard Deviation|Mean
1318788|NCT02331446|Secondary|Change in Performance in the Six-minute Walk Test||Weeks 0 and 12||||Meters||Standard Deviation|Mean
1318789|NCT02331446|Primary|Change in Glutathione Peroxidase Activity||Weeks 0, 6 and 12||||U/mg protein||Standard Deviation|Mean
1318790|NCT02331446|Primary|Change in Total Thiol Content||Weeks 0, 6 and 12||||nmol TNB/mg protein||Standard Deviation|Mean
1318791|NCT02331446|Primary|Change in Thiobarbituric Acid Reactive Substances||Weeks 0, 6 and 12||||nmol TBARS/mg protein||Standard Deviation|Mean
1318792|NCT02331446|Primary|Change in Butyrylcholinesterase Activity||Weeks 0, 6 and 12||||µmol BuSCh/h/mg of protein||Standard Deviation|Mean
1318793|NCT02331446|Primary|Change in Adenosine Deaminase Activity||Weeks 0, 6 and 12||||U/L||Standard Deviation|Mean
1318794|NCT02331446|Primary|Change in Interleukin-6||Weeks 0, 6 and 12||||pg/mL||Inter-Quartile Range|Median
1318795|NCT02331368|Secondary|The Estimated Percentage of Patients Alive at 2 Years||2 Years|32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation and were included in primary endpoint analysis.|||percentage of patients|||Number
1318796|NCT02331368|Secondary|The Estimated Percentage of Patients Alive Without Relapse or Progression at 2 Years|"Progression is defined as an increase of ≥ 25% from the lowest response value in any one or more of the following:~Serum M-component with an absolute increase ≥ 0.5 g/dL; and/or Urine M-component with an absolute increase ≥ 200 mg/24 hours; and/or Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be >100mg/l) Bone marrow plasma cell percentage (absolute % must be ≥10% Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium >11.5mg/100ml) that can be attributed solely to the plasma cell proliferative disorder"|2 Years|32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation and were included in primary endpoint analysis.|||percentage of patients||95% Confidence Interval|Number
1318819|NCT02330055|Secondary|Oxygen Desaturation Index > 3|ODI (oxygen desaturation index), assessed by pulse oximetry during the first night after delivery. ODI is defined as number of desaturation events per hour; a desaturation event is defined as drop in SpO2 of 3% or more from baseline SpO2. Baseline SpO2 is defined as the mean SpO2 of the SpO2 values taken over the preceding 120 seconds.|48 hours after delivery||||1/hr||Inter-Quartile Range|Median
1318820|NCT02330055|Primary|SpO2 < 90%|Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery|48 hours after delivery||||minutes||Inter-Quartile Range|Median
1318801|NCT02330588|Secondary|Parents' Concern About Children's Weight Status and Motivation to Change Lifestyle Behaviors Immediately Following the SBIRT.|"A brief, eight-item Likert scale questionnaire with established face validity has been adopted from Campbell et al. (2011) and will assess parents’ concern for and motivation to support their child’s lifestyle behaviors. Concern and motivation to change were measured on a 5-point Likert scale ('strongly disagree' [0] to 'strongly agree' [4]); for example, I am ready to change my child's lifestyle behaviors, a 0 would indicate that participants strongly disagree with this statement."|Measured at baseline||||units on a scale (0 to 4 Likert Scale)||95% Confidence Interval|Mean
1318802|NCT02330588|Primary|Feasibility (Parents' Uptake of the SBIRT)|Parents' uptake was determined by parents’ use (actual and self-reported) of obesity prevention resources (i.e., the proportion [reported in percentage] that actually or self-reported using resources out of the total number of participants that participated in follow-up), and the proportion (reported in percentage) of parents that reported discussing children’s weight with their pediatrician immediately following the SBIRT.|One-month follow-up|Participants who completed one-month follow-up.|||percentage of participants|||Number
1318803|NCT02330588|Primary|Feasibility (Parents’ Interest in the SBIRT.)|Parents' interest was determined by the proportion (indicated as a percentage) of parents that (i) enrolled among those approached to participate, (ii) ‘opted in’ to receive the tailored email report, and (iii) self-selected resources from the SBIRT; the latter two were recorded by back-end programming of the SBIRT.|Baseline|Parents who participated at baseline.|||percentage of parents|||Number
1318804|NCT02330523|Secondary|Wound Closure at 4-weeks|Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.|4-weeks||||mm||Standard Deviation|Median
1318805|NCT02330523|Secondary|New Bone Plus Graft Content at 6-months|"New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the new healing area."|Six Months||||percentage of total area||Standard Deviation|Mean
1318806|NCT02330523|Primary|Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months|The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.|Six Months||||mm||Standard Deviation|Mean
1318807|NCT02330276|Secondary|Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||ng/mL*24hr||Standard Deviation|Mean
1318808|NCT02330276|Secondary|Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||uU/mL*24 hr||Standard Deviation|Mean
1318809|NCT02330276|Secondary|Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||mg/dL*24hr||Standard Deviation|Mean
1318810|NCT02330276|Secondary|Change From Baseline in Major Safety Endpoints|Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN).|Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||participants|||Number
1318811|NCT02330276|Primary|Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites|This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers|Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||nM*hr||Standard Deviation|Mean
1318812|NCT02330172|Secondary|Recovery Time From Neuromuscular Blockade|We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9|from the injection of neostigmine or sugammadex up to 30 minutes||||minute||Standard Deviation|Mean
1318813|NCT02330172|Primary|Laryngoscopic Score|"Definitions for evaluation of Laryngoscopycondition.~: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.~Variables Excellent Good Poor"|At the beginning of surgery, the surgeon rated the laryngoscopy condition|"Definitions for evaluation of Laryngoscopycondition.~: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.~Variables Excellent Good Poor"|||Participants|||Count of Participants
1318814|NCT02330055|Secondary|Average Pulse Rate|As measured in beats per minute|48 Hours after delivery||||beats per minute||Inter-Quartile Range|Median
1318815|NCT02330055|Secondary|Pain-score on a Verbal Numerical Rating Scale|Assessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain.|48 hours after delivery||||units on a scale||Inter-Quartile Range|Median
1318816|NCT02330055|Secondary|STOP-BANG Score|The STOP BANG (This abbreviation consists of the first letter of each question in the questionnaire. S-Snore, T-Tired, O-Observed stop in breathing, P-High blood pressure, B-BMI, A - Age, N-Neck circumference, G-Gender. This questionnaire is a proven tool that can be used to screen for obstructive sleep apnea (OSA). This tool will assess if you are low, moderate or high risk group for sleep apnea. Scores range from 0-8. 0 indicates low risk for sleep apnea, 8 indicates high risk for sleep apnea.|48 hours after delivery||||units on a scale||Inter-Quartile Range|Median
1318817|NCT02330055|Secondary|P-SAP Score|A Perioperative sleep apnea prediction (P-SAP) Score. This score ranges from 0 to 69, 0 representing low risk of obstructive sleep apnea and 69 representing high risk of obstructive sleep apnea.|48 hours after delivery|The number analyzed per row differs from the overall number because the analysis was distinguished down by type of delivery and upper body position. Thus, 20 patients belong to each group as seen below.|||units on a scale||Inter-Quartile Range|Median
1318827|NCT02329964|Primary|Addition of Neuromuscular Blocking Agents|"Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed.~In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery.~We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery"|during surgery||||participants|||Number
1318828|NCT02329964|Primary|Surgical Rating Score|"describe by surgeon under his subjective opinion.~1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions"|during surgery||||score||Inter-Quartile Range|Median
1318829|NCT02329964|Primary|Recovery of T1 to 90%|we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes||||seconds||Inter-Quartile Range|Median
1318830|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .|||participants|||Number
1318831|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .|||participants|||Number
1318832|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|72 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .|||participants|||Number
1318833|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.~The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10"|72 hours after intradermal injection||||participants|||Number
1318834|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10.|||participants|||Number
1318835|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .|||participants|||Number
1318836|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|24 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .|||participants|||Number
1318837|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours before injection with drug.The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in in TB participants.|144 hours after injection||||participants|||Number
1318838|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours after injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|144 hours after injection||||participants|||Number
1318839|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 72 hours after injection with drug.The percentage of positive(positivenumber/total number*100%) is the sensitivity of IFN-γ in in TB participants.|72 hours after injection||||participants|||Number
1318840|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|72 hours after injection||||participants|||Number
1318841|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug. The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in TB Participants.|4 hours before injection and after signed ICF(informed consent forms)||||participants|||Number
1318842|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|before injection and after signed ICF(informed consent forms)||||participants|||Number
1318843|NCT02329730|Secondary|the Number of Participants With Adverse Events|"evaluate specific time point of vital signs, skin test reaction, blood routine, urine routine, liver and kidney function, electrocardiogram and adverse events as the incidence of adverse events in the participants .~Skin test reaction observation time: at the end of the skin test, skin test after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours; Vital signs evaluation time: 0 minutes before the subjects were intradermal injection, intradermal injection after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours, 144 hours.~Blood routine, urine routine, liver and kidney function, electrocardiogram (ecg) evaluation time: skin test before and 144 h after injection; adverse events evaluation time: participants signed a written informed consent to finish all the follow-up."|before injection to 144 hours (plus or minus 2 hours) after injection||||participants|||Number
1318844|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.~The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 ."|24 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .|||participants|||Number
1318845|NCT02329600|Secondary|Salivary Total Oxidative Capacity|total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment|one month after treatment||||umol/L||Standard Deviation|Mean
1318846|NCT02329600|Primary|Pain|pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment|one month after treatment||||units on a scale||Standard Deviation|Mean
1318847|NCT02329587|Secondary|Rates of Retention in Intervention|Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.|Approximately 6.5 weeks post-baseline||||Participants|||Count of Participants
1318848|NCT02329587|Secondary|Client Satisfaction Questionnaire-8: Total Score|The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.|1-month follow up (Approximately 11 weeks after baseline assessment)|All available data for participants who completed the 1-month follow-up assessment|||units on a scale||Standard Deviation|Mean
1318849|NCT02329587|Secondary|Yale-Brown Obsessive-Compulsive Scale: Total Score|The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.|1-month follow up (Approximately 11 weeks after baseline assessment)|All available data for participants who completed the 1-month follow-up assesment|||units on a scale||Standard Deviation|Mean
1318850|NCT02329587|Primary|Rates of Session Completion|Average number of intervention sessions completed|Approximately 6.5 weeks post-baseline||||Sessions||Full Range|Mean
1318851|NCT02329587|Primary|Client Satisfaction Questionnaire-8: Total Score|The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.|Post-treatment (approximately 6.5 weeks post-baseline)|All participants with available data on outcome measure|||units on a scale||Standard Deviation|Mean
1318852|NCT02329587|Primary|Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score|The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.|Post-treatment (approximately 6.5 weeks post-baseline)|All participants with available data at the outcome timepoint|||units on a scale||Standard Deviation|Mean
1318853|NCT02329431|Secondary|Child Visit No-shows Over 4 Months|We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit no-shows were measured by number of visits missed.|baseline to 4-month follow-up|Target child with any scheduled visits|||visits||Standard Deviation|Mean
1318854|NCT02329431|Secondary|Number of Clinic Visits Child Attended Over 4 Months|We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit attendance was measured by number of visits attended.|baseline to 4-month follow-up|Target child with any scheduled clinic visits|||visits||Standard Deviation|Mean
1318855|NCT02329431|Secondary|Parent Activation, Qualitative|We collected qualitative data on parent-provider communication after completion of the 4-week MePrEPA (metas, preguntar, escuchar, preguntar para aclarar/goals, questioning, listening, questioning to clarify) and parent support groups, in an effort to capture observed activation. We coded when the parent disagreed with therapist and when the parent mentioned speaking with child's teacher.|1 month|Completed baseline interview and had an audio-recorded visit|||Participants|||Count of Participants
1319134|NCT02320838|Secondary|Change From Baseline in Nerve Conduction Amplitude ( µV)|The compound action potential amplitudes ( µV) will be measured.|Baseline,immediately after treatment at 20 min..||||µV||Standard Error|Mean
1318856|NCT02329431|Secondary|Parental Stress Scale|Parent stress was measured with the 17-item Parental Stress Scale. The Parental Stress Scale is scored on a scale from 0 to 75, where higher scores reflect greater stress. It has been translated into Spanish, and has been shown to have excellent validity and reliability (for women, mean=22).|1 and 3 months|Completed a baseline interview|||scores on a scale||Standard Deviation|Mean
1318857|NCT02329431|Secondary|8-item Patient Health Questionnaire (PHQ-8)|Parent depression was measured with the 8-item Patient Health Questionnaire (PHQ-8). The PHQ-8 is scored on a scale from 0 to 27; a higher score reflects greater severity of depression. It has excellent validity and reliability. The parent PHQ-9 has been translated into Spanish and used successfully in Latina/o populations. A change of 5 points in the PHQ-8 is associated with a shift in level of depression.|1 and 3 months|Completed a baseline interview|||scores on a scale||Standard Deviation|Mean
1318858|NCT02329431|Primary|Patient Activation Measure|The Patient Activation Measure (PAM) captured parent activation on behalf of their child. The PAM is an adult self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100. Higher scores indicate higher activation. It is valid with excellent reliability. The PAM has been translated into Spanish and has been used successfully in Latina/o patient and general populations (mean=40). The PAM has also been used to measure activation of parents on behalf of their children (mean=70). A change of 4 points in the PAM is associated with improved health behaviors in the general population.|1 and 3 months|Completed a baseline interview|||scores on a scale||Standard Deviation|Mean
1318859|NCT02329223|Secondary|Percentage of Participants With Production of Anti-omalizumab Antibody|Serum samples were collected for anti-omalizumab antibody testing.|Week 24|The safety analysis set, which included all participants who received their assigned study treatment, were considered for the analysis. Only participants, who had antibody results (conclusive or inconclusive), were analyzed.|||Percentage of participants|||Number
1318860|NCT02329223|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement.|Baseline to Week 12|Only participants from the FAS, who were greater than age 16, were analyzed. The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1318861|NCT02329223|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|Complete responders are defined as participants who achieved UAS7 = 0.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Percentage of participants|||Number
1318862|NCT02329223|Secondary|Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12|Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Percentage of participants|||Number
1318863|NCT02329223|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1318864|NCT02329223|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Percentage of participants|||Number
1318865|NCT02329223|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1318876|NCT02328404|Primary|Sex Hormone Binding Globulin Concentration|"Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms.~One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration.~In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||nmol/L||Standard Deviation|Mean
1318866|NCT02329223|Secondary|Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1318867|NCT02329223|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria(CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1318868|NCT02329015|Other Pre-specified|Teacher Report Behavior Rating Inventory of Executive Function|Teacher reported 87 item questionnaire on students executive function and self regulation. The BRIEF for teachers measures 8 non-overlapping theoretically and empirically derived clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|One year|3 subjects missing from experimental group and 5 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
1318869|NCT02329015|Other Pre-specified|Student Self-Report Behavior Rating Inventory of Executive Function|An 80 item self-report questionnaire assessing executive function and self regulation. The BRIEF-SR measures 8 non-overlapping clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis. Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|1 year|9 subjects missing from experimental group and 9 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
1318870|NCT02329015|Other Pre-specified|Self Report Questionnaire (Child and Adolescent Mindfulness Measure)|A 10 item self-report measure assessing mindfulness skills (Scale 1-4). Items are reverse scored and summed (not mean). Higher scores mean more positive mindfulness skills. Min and maximum scores are 0-40.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
1318871|NCT02329015|Secondary|Warwick Edinburgh Mental Well Being Scale|A 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
1318872|NCT02329015|Secondary|Response to Stress Questionnaire (RSQ)|A 57-item self-report questionnaire that was used as a measure of emotional regulation We examined two of the five constructs (24 of the 57 items) within the RSQ as these were most directly theoretically relevant to expected changes due to yoga practice: voluntary engagement and involuntary engagement. Higher values represent higher levels of negative stress responses. Values for the voluntary engagement subscale represent the mean value across 9 questions on the survey and values for the involuntary subscale represent the mean value across 15 questions on the survey. Values for each item range from 0-3, trherefore the total mean values reported as outcomes range from 0-3.|1 year|Missing data: 2 from experimental group, none from control group|||units on a scale||Standard Deviation|Mean
1318873|NCT02329015|Primary|Academic Performance: Grade Point Averages|GPA was calculated as the numeric average of course scores of all courses taken by the student weighted by credit load of each course using a standard process within NYC public schools.|1 year|Intent to treat analysis. Data from all participants was available at baseline and at end of study.|||per cent||Standard Deviation|Mean
1318874|NCT02328937|Secondary|Limbal Redness|Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.|6-8 hours post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of this study.|||units on a scale||Standard Deviation|Mean
1318875|NCT02328937|Primary|Central Corneal Swelling|Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.|6-8 Hours Post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of the study.|||um||Standard Deviation|Mean
1318877|NCT02328404|Primary|Free Androgen Index|"Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG).~In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index.~One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||Ratio||Standard Deviation|Mean
1318878|NCT02328404|Primary|Total Testosterone Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment.~In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol.~One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms.~the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||nmol/L||Standard Deviation|Mean
1318879|NCT02328404|Primary|Serum Progesterone Level|"The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms.~The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level.~One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||nmol/L||Standard Error|Mean
1318880|NCT02328404|Secondary|Serum C-Reactive Protien Concentration|"Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment.~In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||mg/L||Standard Error|Mean
1318881|NCT02328404|Primary|Hirsutism Score|"The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth).~In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms."|3 months||||units on a scale||Standard Error|Mean
1318882|NCT02328404|Secondary|Serum Phosphorous Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||mmol/L||Standard Error|Mean
1318883|NCT02328404|Secondary|Serum Calcium Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||mmol/L||Standard Error|Mean
1318884|NCT02328404|Primary|Menstrual Regularity|"Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level > 4 ng/mL.~One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity.~In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol.~The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||participants|||Number
1318885|NCT02328404|Secondary|Serum Parathyroid Hormone Concentration|"Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period.~In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||Pg/ml||Standard Error|Mean
1319139|NCT02320838|Primary|Nerve Conduction Latency Immediately After Treatment|The compound action potential latencies will be measured and will be expressed in ms.|immediately after treatment at 20 min.||||ms||Standard Deviation|Mean
1318886|NCT02328404|Secondary|Body Mass Index|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be <25-30 kg/m^2.~Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms.~In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months)."|3 months||||kg/m^2||Standard Error|Mean
1318887|NCT02328404|Secondary|Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame.~In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI)."|3 months||||mmol/L||Standard Error|Mean
1318888|NCT02328404|Secondary|Serum Chromium Concentration|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be > 0.05 and < 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3.~In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||ppm||Standard Error|Mean
1318889|NCT02328404|Secondary|Serum 25-Hydroxy Vitamin D3 Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D > 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment .~In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms."|3 months||||ng/ml||Standard Error|Mean
1318890|NCT02328404|Primary|Ultrasound Examination of Number of Follicles and Ovarian Volume|"Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination.~In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic.~An improvement in PCOS prognosis clinically by ultrasound examination is defined by:~decreasing the number of follicles to < 12 follicles measuring 2-9 mm in diameter~decreasing ovarian volume to < 10 cm3"|3 months|The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value</= 0.05)|||participants|||Number
1318891|NCT02328105|Secondary|Duration of Disease Control|For subjects who achieve SD or better, duration of disease control will be measured from the treatment start date until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.|From date of treatment start to date of progression, or censored as described above.||2020-11-30|11/2020||||
1318892|NCT02328105|Secondary|Duration of Response|For subjects who achieve a CR or PR, response duration will be measured from the first day of the response until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.|From date of response to date of progression/death, or censored as described above.||2020-11-30|11/2020||||
1318893|NCT02328105|Secondary|Overall Survival|OS is defined as the duration of time from treatment start date to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.|From date of treatment start to date of death, or censored as described above.||2020-11-30|11/2020||||
1318894|NCT02328105|Secondary|Progression Free Survival|PFS is defined as the duration of time from treatment start date to time of progression or death. Disease progression may be determined objectively as per RECIST 1.1 or subjectively as determined by the investigator. Evidence for subjective progressions must be documented in the eMR. For objective disease progression, date of PD is date of the radiologic assessment that identified RECIST-defined progressive disease. For subjective disease progression, date of PD is the date that the clinician makes the determination of disease progression. If the subject died without documented disease progression, date of progression will be date of death. For surviving subjects who do not have objectively documented disease progression, PFS will be censored at the date of last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented disease progression, PFS will be censored at date of last radiologic assessment prior to commencement of subsequent therapy.|From date of treatment start to date of progression/death, or censored as described above.||2020-11-30|11/2020||||
1318895|NCT02328105|Secondary|Number of Subjects With Stable Disease or Response|Disease control is calculated for each subject indicating whether or not they achieved an overall response of stable disease or better by RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions, a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference, and SD is neither sufficient shrinkage to qualify for PR nor sufficient growth, >=20%, to indicate progression).|18 weeks|The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically).|||Participants|||Count of Participants
1323311|NCT02226198|Secondary|ApoB (mg/dL)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
1318896|NCT02328105|Primary|Number of Participants With a Response|The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.|Up to a planned 18 weeks|The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically)|||Participants|||Count of Participants
1318897|NCT02328040|Secondary|Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo|Serum glucagon concentrations were measured in the CL setting in the treatment arm, sitagliptin, compared to the placebo (Insulin monotherapy)|18 months||||Pmol/L||Standard Deviation|Mean
1318898|NCT02328040|Primary|Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo|Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy)|18 Months||||mg/dl||Standard Deviation|Mean
1318899|NCT02327429|Secondary|Change in Fasting High-density Lipoprotein Cholesterol|Fasting high-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
1318900|NCT02327429|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol|Low-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
1318901|NCT02327429|Secondary|Change in Fasting Total Cholesterol|Fasting total cholesterol measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
1318902|NCT02327429|Secondary|Change in Fasting Triglyceride|Fasting triglyceride measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
1318903|NCT02327429|Secondary|Change in Waist Circumference|Waist circumference measured pre-post intervention from baseline to 3 months|12 weeks||||cm||Standard Deviation|Mean
1318904|NCT02327429|Secondary|Change in Body Mass Index (BMI)|Body mass index calculated from weight measured pre-post and height measured pre-intervention from baseline to 3 months|12 weeks||||kg/m2||Standard Deviation|Mean
1318905|NCT02327429|Secondary|Change in Hemoglobin A1c (A1c)|Hemoglobin A1c measured in capillary blood pre-post intervention from baseline to 3 months|12 weeks||||% of A1c in blood||Standard Deviation|Mean
1318906|NCT02327429|Primary|Change in Cholesterol Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks||||milligrams||Standard Deviation|Mean
1318907|NCT02327429|Primary|Change in Calcium Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks||||milligrams||Standard Deviation|Mean
1318908|NCT02327429|Primary|Change in Sodium Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks||||milligrams||Standard Deviation|Mean
1318909|NCT02327429|Primary|Change in Added Sucrose Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
1318910|NCT02327429|Primary|Change in Dietary Fibre Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||grams||Standard Deviation|Mean
1318911|NCT02327429|Primary|Change in Saturated Fat Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
1318912|NCT02327429|Primary|Change in Total Fat Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
1318913|NCT02327429|Primary|Change in Protein Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
1318914|NCT02327429|Primary|Change in Carbohydrate Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
1318915|NCT02327429|Primary|Change in Energy Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||kcal||Standard Deviation|Mean
1318916|NCT02327143|Secondary|PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219||Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data|||hours||Full Range|Median
1318917|NCT02327143|Secondary|PK: Maximum Observed Concentration (Cmax) of LY2835219||Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1318918|NCT02327143|Primary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219||Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data|||nanogram*h/milliliter (ng∙h/mL)||Geometric Coefficient of Variation|Geometric Mean
1318919|NCT02327117|Primary|Hb Level 48 Hours After Total Knee Arthroplasty||48 hours after TKA||||gr/dL||Standard Deviation|Mean
1318920|NCT02327013|Secondary|Change in AAQoL Subscales - Relationships Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Relationship subscale is based on 5 items and ranges from 5 to 25. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1329619|NCT02107014|Primary|Change in IL-4 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1318921|NCT02327013|Secondary|Change in AAQoL Subscales - Life Outlook Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life Outlook subscale is based on 7 items and ranges from 7 to 35. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318922|NCT02327013|Secondary|Change in AAQoL Subscales - Psychological Health Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Psychological Health subscale is based on 6 items and ranges from 6 to 30. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318923|NCT02327013|Secondary|Change in AAQoL Subscales - Life Productivity Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life productivity subscale is based on 11 items and ranges from 11 to 55. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318924|NCT02327013|Secondary|Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Total score is based on all 29 items and ranges from 29 to 145. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318925|NCT02327013|Secondary|Change in WLQ Domain Scores - Output Demands|Output Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318926|NCT02327013|Secondary|Change in WLQ Domain Scores - Physical Demands|Physical Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318927|NCT02327013|Secondary|Change in WLQ Domain Scores - Mental-Interpersonal Work Demands|Mental-Interpersonal Work Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318928|NCT02327013|Secondary|Change in WLQ Domain Scores - Limitations Handling Time|Limitations Handling Time is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318929|NCT02327013|Secondary|Change in WLQ Using the Global Productivity Index|"The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from All of the Time (score 5) to None of the Time (score 0), or Does Not Apply to My Job. The Global Productivity Index is calculated as a weighed sum of the 4 dimensions, and ranges from 0.000 to 0.286. Reduction in score indicates less work limitation."|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||Index||Standard Error|Least Squares Mean
1318930|NCT02327013|Secondary|Change in SDS Item Scores - Number of Underproductive Days|This SDS item captures the number of underproductive days (see outcome 4)|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||days||Standard Error|Least Squares Mean
1319140|NCT02320838|Primary|Thermal Pain Threshold During Treatment|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|during treatment at 15 min.||||ºC||Standard Deviation|Mean
1318931|NCT02327013|Secondary|Change in SDS Item Scores - Number of Days Lost|This SDS item captures days lost from school or work (see outcome 4).|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||days||Standard Error|Least Squares Mean
1318932|NCT02327013|Secondary|Change in SDS Item Scores - Social Life|The SDS item social life is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318933|NCT02327013|Secondary|Change in SDS Item Scores - Work|The SDS item work is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318934|NCT02327013|Secondary|Change in SDS Item Scores - Family|The SDS item family is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318935|NCT02327013|Secondary|Change in PDQ-D Sub-scales - Planning and Organisation Sub-score|The PDQ-D planning and organisation sub-score consists of items 4, 8, 12, 16, and 20 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318936|NCT02327013|Secondary|Change in PDQ-D Sub-scales - Prospective Memory Sub-score|The PDQ-D prospective memory sub-score consists of items 3, 7, 11, 15, and 19 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318937|NCT02327013|Secondary|Change in PDQ-D Sub-scales - Retrospective Memory Sub-score|The PDQ-D retrospective memory sub-score consists of items 2, 6, 10, 14, and 18 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318938|NCT02327013|Secondary|Change in PDQ-D Subscales - Attention and Concentration Sub-score|The PDQ-D attention/concentration sub-score consists of items 1, 5, 9, 13, and 17 of the PDQ with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318939|NCT02327013|Secondary|Change in Perceived Deficits Questionnaire – Depression (PDQ-D) Total Score|The PDQ-D is a patient-rated scale designed to assess cognitive impairment/dysfunction adapted for MDD. Each item is rated on a scale from 0 (never) to 4 (almost always). The total score of the 20 items ranges from 0 to 80 with higher scores reflect greater subjective cognitive impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318940|NCT02327013|Secondary|Change in BRIEF-A Subscales - Emotional Control|The BRIEF-A subscale Emotional Control is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318941|NCT02327013|Secondary|Change in BRIEF-A Subscales - Working Memory|The BRIEF-A subscale Working Memory is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318942|NCT02327013|Secondary|Change in BRIEF-A Subscales - Task Monitor|The BRIEF-A subscale Task Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318943|NCT02327013|Secondary|Change in BRIEF-A Subscales - Self Monitor|The BRIEF-A subscale Self Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318944|NCT02327013|Secondary|Change in BRIEF-A Subscales - Shift|The BRIEF-A subscale Shift is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318945|NCT02327013|Secondary|Change in BRIEF-A Subscales - Planning/Organize|The BRIEF-A subscale Planning/Organize is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318946|NCT02327013|Secondary|Change in BRIEF-A Subscales - Organization of Materials|The BRIEF-A subscale Organization of Materials is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318947|NCT02327013|Secondary|Change BRIEF-A Subscales - Initiate|The BRIEF-A subscale Initiate is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318948|NCT02327013|Secondary|Change in BRIEF-A Subscales - Inhibit|The BRIEF-A subscale Inhibit is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318949|NCT02327013|Secondary|Change in BRIEF-A Using the Behavioural Regulation Index|The Behavioral Regulation Index (BRI) is an index score of the BRIEF-A and consists of 4 scales: inhibit, shift, emotional control, and self-monitor). Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318950|NCT02327013|Secondary|Response (Defined as a CGI-I Score of 1 or 2), Stage 1|The Clinical Global Impression – Global Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.|Week 6|CGI-I refers to study baseline and was for this reason analyzed for Stage 1 only.|||percentages of participants|||Number
1318951|NCT02327013|Secondary|Clinical Global Impression – Global Improvement (CGI-I) Score|The Clinical Global Impression – Global Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.|Week 6|CGI-I refers to study baseline and was for this reason analyzed for Stage 1 only.|||units on a scale||Standard Error|Least Squares Mean
1318952|NCT02327013|Secondary|Change in Clinical Global Impression – Severity of Illness (CGI-S) Score|The Clinical Global Impression – Severity of Illness (CGI-S) provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318953|NCT02327013|Secondary|Change in Adult ADHD Self-Report Scale (ASRS) Total Score|"The Adult ADHD Self-Report Scale (ASRS) is a patient-rated scale designed to assess the ADHD symptoms in adults based on the diagnostic criteria of DSM-IVTM. The ASRS consist of 18 items, each rated on a 5-point scale from Never to Very Often. The categories “Never” and “Rarely” were combined when calculating the total score to mirror the scoring of the AISRS, with 0 representing “Never”/”Rarely” and 3 representing “Very Often”. The Total Score ranges from 0 to 54. A reduction in score indicates less severity of ADHD."|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318954|NCT02327013|Secondary|Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score)|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined response rate was obtained by constructing an equally weighed estimate of the rate combining the two stages.|||percentage of participants|||Number
1318955|NCT02327013|Secondary|Change AISRS Hyperactivity/Impulsivity Sub-score|The AISRS hyperactive/impulsive subscale score consists of 9 items from the AISRS which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318956|NCT02327013|Secondary|Change in AISRS Inattention Sub-score|The AISRS inattentive subscale score consists of 9 items from the AISRS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318957|NCT02327013|Secondary|Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score|"The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from All of the Time (score 5) to None of the Time (score 0), or Does Not Apply to My Job. The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24,9%."|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||percentage of days lost||Standard Error|Least Squares Mean
1318958|NCT02327013|Secondary|Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score|The SDS comprises a series of patient rated scales designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and 3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment. The number of days lost and the number of underproductive days last from work/school due to symptoms are also captured. The total score is calculated as a sum of the 3 visual analogue scales, ranges from 0 to 30. A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318959|NCT02327013|Secondary|Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score|BRIEF-A is a validated questionnaire composed of 75-item within nine non-overlapping scales: 4 scales in the Behavioral Regulation Index (BRI) (inhibit, shift, emotional control, and self-monitor), and 5 scales in the Metacognition Index (MI) (initiate, working memory, plan/organise, task monitor, and organization of materials). Each item is rated on a 3-point scale with the numeric score of 1 to 3. The BRIEF-A yields an overall score (Global Executive Composite) composed of two index scores, the MI and the BRI. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318960|NCT02327013|Secondary|Inattention/Meta-cognition: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Using Metacognition Index|The Metacognition Index (MI) is an index score of the BRIEF-A consisting of 5 scales: initiate, working memory, plan/organise, task monitor, and organization of materials. Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
1318961|NCT02327013|Primary|Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
1318962|NCT02326844|Other Pre-specified|Secondary Mutation of Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2)|Patients will undergo a mandatory biopsy at baseline and Next Generation Sequencing to elucidate the secondary mutations of BRCA1 and BRCA2 will be performed.|Baseline||2020-03-31|03/2020||||
1318963|NCT02326844|Other Pre-specified|Forkhead Box 03 (FOXO3a), p53-binding Protein 1 (53BP1) and RAD51 (i.e., Eukaryote Gene) Biomarkers|Patients will undergo a mandatory biopsy at baseline and reverse phase protein microarray (RPPA)26 testing will be performed to determine the potential predictive biomarkers of subsequent poly (adenosine diphosphate [ADP]) ribose polymerase inhibitors (PARPi ) response.|Baseline||2020-03-31|03/2020||||
1318964|NCT02326844|Secondary|Progression Free Survival (PFS) on BMN673 (Talazoparib) to PFS From First Poly (ADP-ribose) Polymerase Inhibitor (PARPPi) Exposure|The median time to progression after receiving BMN673 will be compared informally to the time of progression for the same patients after receiving an initial PARPi exposure. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progressions).|3 months|This outcome measure was not done because the study was prematurely closed by the Cancer Therapy Evaluation Program (CTEP) sponsor following the enrollment of 3 subjects. We were unable to analyze biomarker endpoints due to insufficient number of samples after premature closure of the study.||||||
1318965|NCT02326844|Secondary|Duration of Response|Duration of response is the time between study enrollment and off-treatment date.|3 months||||months||Full Range|Median
1318966|NCT02326844|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v4.0. For a detailed list of events, see the adverse event module.|15 months||||Participants|||Count of Participants
1318967|NCT02326844|Primary|Objective Response (Complete Response (CR) + Partial Response (PR))|Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Every 2 cycles, an average of 64 days||||Participants|||Count of Participants
1318968|NCT02326649|Primary|Mean Difference in Stroke Volume Between CMR and SMIC|Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml|2 hours||||ml||95% Confidence Interval|Mean
1318969|NCT02326298|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|At Week 48|The Randomized Set included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
1318970|NCT02326298|Secondary|Proportion of Subjects Who Achieve a Physician’s Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.|At Week 48|The Randomized Set included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
1318971|NCT02326298|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients’ health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than of equal to (>=)4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015)a DLQI absolute score of lower than or equal to (=<)1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).|At Week 16|The Randomized Set included all subjects randomized into the study. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.|||Scores on a scale||Standard Error|Least Squares Mean
1318979|NCT02326272|Primary|Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 16|The Randomized Set (RS) included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318972|NCT02326298|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|At Week 16|The Randomized Set included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318973|NCT02326298|Primary|Proportion of Subjects Who Achieve a Physician’s Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.|At Week 16|The Randomized Set included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318974|NCT02326298|Primary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|At Week 16|The Randomized Set included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318975|NCT02326272|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients’ health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=)4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015)a DLQI absolute score of lower than or equal to (=<)1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).|Week 16|The Randomized Set (RS) included all subjects randomized into the study. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.|||Scores on a scale||Standard Error|Least Squares Mean
1318976|NCT02326272|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.|Week 48|The Randomized Set (RS) included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
1318977|NCT02326272|Secondary|Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 48|The Randomized Set included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
1318978|NCT02326272|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0 =no disease, the maximum score is 72=maximal disease.|Week 16|The Randomized Set (RS) included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318980|NCT02326272|Primary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person’s affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.|Week 16|The Randomized Set (RS) included all subjects randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
1318981|NCT02325856|Secondary|Complications During DW Adjustment|we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator).|1 year||||% of months in which compli|Participants||Number
1318982|NCT02325856|Primary|All-cause Hospitalization||1 year||||hospitalizations per patient-year||95% Confidence Interval|Number
1318983|NCT02325713|Secondary|Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters|Vital signs included oral body temperature, blood pressure and pulse rate. Body weight was recorded for physical examinations. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation including chemistry, hematology and urinalysis.|Baseline up to end of treatment (up to Day 32)|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.|||subjects|||Number
1318984|NCT02325713|Secondary|Palatability Assessment Based on Visual Analog Scale (VAS) Score|"Palatability was assessed in terms of Flavor, Smell, Sweetness, Overall liking of the medicine, Taste and Acceptability to swallow, each parameter assessed on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 indicates Did not like and 100 indicates very much liked. Flavor, Smell, Sweetness and Overall liking of the medicine were evaluated immediately after taking the medication (Day 1, 0 Hour) and Taste and Acceptability to swallow were assessed 2-5 minutes post administration of medication."|Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.|||millimiter (mm)||Standard Deviation|Mean
1318985|NCT02325713|Secondary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the stud drug.|Baseline up to end of treatment (up to Day 32)|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.|||subjects|||Number
1318986|NCT02325713|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ|AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of D-PZQ and Racemate PZQ.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1318987|NCT02325713|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose was influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|"The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, n signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively."|||Liters||Geometric Coefficient of Variation|Geometric Mean
1318988|NCT02325713|Secondary|Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
1319135|NCT02320838|Secondary|Change Current Density (mA/cm2)|Change in current density (mA/cm2), it will be recorded at 1 min. start of the treatment session and at 20 min of the same.|at 1 min. treatment session, at 20 min. treatment session|"Sham stimulation arm was not included in the analysis of change current density because in the Sham group no current was applied."|||mA/cm2||Standard Deviation|Mean
1318989|NCT02325713|Secondary|Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ|Frel was calculated for Treatment A versus Treatment B only. It was calculated by using AUC0-∞, with treatment A as the Test and treatment B as the Reference. Frel = AUC0-inf (test) / AUC0-inf (reference).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||percent bioavailability||Geometric Coefficient of Variation|Geometric Mean
1318990|NCT02325713|Secondary|Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ|λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1318991|NCT02325713|Secondary|Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ|AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||percentage of AUC0-inf||Geometric Coefficient of Variation|Geometric Mean
1318992|NCT02325713|Secondary|AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1318993|NCT02325713|Secondary|Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||hours||Full Range|Median
1318994|NCT02325713|Secondary|Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ|Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||hours||Geometric Coefficient of Variation|Geometric Mean
1318995|NCT02325713|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||hours||Full Range|Median
1318996|NCT02325713|Secondary|Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1318997|NCT02325713|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ)|AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ.|Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The pharmacokinetic (PK) population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, ‘N’ (number of participants analyzed) signifies those subjects who were evaluable for this outcome measure.|||Hour*nanograms per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1318998|NCT02325518|Secondary|Least Squares Mean Change From Baseline in IOP at 9 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 9 AM|Per Protocol Set (PPS)|||mmHg||95% Confidence Interval|Least Squares Mean
1318999|NCT02325518|Primary|Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 11 AM|This analysis population includes all subjects who received study medication and met inclusion/exclusion criteria prior to randomization (Per Protocol Set).|||mmHg||95% Confidence Interval|Least Squares Mean
1319000|NCT02324673|Primary|Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captured the occurrence, severity, and frequency of suicide related thoughts and behaviors at Day 11. The C-SSRS was only used for participants ≥ 7 years of age. The number of participants with results of “Yes” for Suicidal Ideation (Wish to be Dead and Non-Specific Active Suicidal Thoughts) and Suicidal Behavior (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior, and Suicidal Behavior) are reported.|Day 11|Participants from the Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product, who completed the C-SSRS.|||Participants|||Count of Participants
1319001|NCT02324673|Primary|Change From Baseline in Daily Seizure Activity|The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity.|Baseline and Day 11|EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for number of seizures per day at Day 11.|||number of seizures per day||Standard Deviation|Mean
1319002|NCT02324673|Primary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment|The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant’s mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness).|Baseline and Day 11|EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-S post-dose.|||scores on a scale||Standard Deviation|Mean
1319003|NCT02324673|Primary|Clinical Global Impression of Improvement (CGI-I) Assessment|The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.|Day 11|Efficacy Analysis Population (EFF), all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-I post-dose.|||scores on a scale||Standard Deviation|Mean
1319004|NCT02324673|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention.|From the first dose of study drug up to Day 17|Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product.|||Participants|||Count of Participants
1319005|NCT02324673|Primary|Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age|"Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC[0-inf] on Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 and Day 10|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for time linearity index.|||ratio||Standard Deviation|Mean
1319006|NCT02324673|Primary|Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol|"RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RAUC(0-12).|||ratio||Standard Deviation|Mean
1319007|NCT02324673|Primary|Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol|"RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RCmax.|||ratio||Standard Deviation|Mean
1319008|NCT02324673|Primary|Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cavg.|||ng/mL||Standard Deviation|Mean
1319136|NCT02320838|Secondary|Perception Current Comfortability|Participants will choose the current treatment that has found more comfortable|At the end of the third experimental session, 3 days|"Sham stimulation arm was not included in the analysis of perception current comfortability because in the Sham group no current was applied."|||Participants|||Count of Participants
1319009|NCT02324673|Primary|Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmin.|||ng/mL||Standard Deviation|Mean
1319010|NCT02324673|Primary|Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.|||ng*h/mL/(mg/kg)||Standard Deviation|Mean
1319011|NCT02324673|Primary|AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).|||ng*h/mL||Standard Deviation|Mean
1319012|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.~MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 10 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).|||ratio||Standard Deviation|Mean
1319013|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.~MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).|||ratio||Standard Deviation|Mean
1319014|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.~MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-inf).|||ratio||Standard Deviation|Mean
1319015|NCT02324673|Primary|MRCmax on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.~MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for metabolite to parent ratio.|||ratio||Standard Deviation|Mean
1319024|NCT02324673|Primary|Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for λz.|||1/h||Standard Deviation|Mean
1319016|NCT02324673|Primary|Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.~MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRCmax.|||ratio||Standard Deviation|Mean
1319017|NCT02324673|Primary|Dose Normalized AUC(0-inf) [AUC(0-inf)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf)/D.|||ng*h/mL/(mg/kg)||Standard Deviation|Mean
1319018|NCT02324673|Primary|AUC From Time 0 to Infinity [AUC(0-inf)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf).|||ng*h/mL||Standard Deviation|Mean
1319019|NCT02324673|Primary|AUC From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] on Day 1 for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-last).|||ng*h/mL||Standard Deviation|Mean
1319020|NCT02324673|Primary|Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.|||ng*h/mL||Standard Deviation|Mean
1319021|NCT02324673|Primary|Area Under the Plasma-Concentration Time Curve From 0 to 12 Hours Post-dose [AUC(0-12)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).|||ng*h/mL||Standard Deviation|Mean
1319022|NCT02324673|Primary|Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Vz/F.|||L/kg||Standard Deviation|Mean
1319023|NCT02324673|Primary|Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for CL/F.|||Liters (L)/h/kg||Standard Deviation|Mean
1319025|NCT02324673|Primary|Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for t1/2.|||h||Standard Deviation|Mean
1319026|NCT02324673|Primary|Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.|||h||Full Range|Median
1319027|NCT02324673|Primary|Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.|||hours (h)||Full Range|Median
1319028|NCT02324673|Primary|Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||ng/mL/(mg/kg)||Standard Deviation|Mean
1319029|NCT02324673|Primary|Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||ng/mL/(mg/kg)||Standard Deviation|Mean
1319030|NCT02324673|Primary|Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||ng/mL||Standard Deviation|Mean
1319031|NCT02324673|Primary|Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|Pharmacokinetic population (PK), all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
1319032|NCT02324660|Other Pre-specified|Cardiac Death|occurrence of cardiac death|1 year|||||||
1319033|NCT02324660|Other Pre-specified|Adverse Events|hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia|1 year after inclusion|||||||
1319034|NCT02324660|Secondary|Undiagnosed COPD|percentage of patients admitted to hospital for ACS and with undiagnosed COPD|2 months|||||||
1319035|NCT02324660|Secondary|Cardiac Adverse Events|cumulative occurrence of death, myocardial infarction and heart failure|1 year after inclusion||||partecipants|||Number
1319036|NCT02324660|Primary|COPD Diagnosis|COPD diagnosis confirmed by spirometry|2 months after inclusion||||participants|||Number
1319037|NCT02324504|Primary|Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)|"Successful placement (based upon review of chest radiograph) of the PICC as determined by the tip location of:~RA SVC junction (right atrium/superior vena cava) or~Distal or lower SVC"|Less than 24 hours||||Participants|||Count of Participants
1319038|NCT02324049|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event (AE) that occurred after administration of the first dose of study drug on Day 1 (Part A). A severe AE was defined as an AE that was incapacitating and required medical intervention. TEAEs were summarized cumulatively over the entire study and separately for Part C, data for all severe TEAEs throughout the entire study is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline to Week 142|Safety Population: all participants for whom informed consent had been obtained, who had a confirmed diagnosis of MPS IIIB, and who had received any amount of SBC-103.|||Participants|||Count of Participants
1319039|NCT02323854|Secondary|Number of Participants With Complete or Incomplete Tumor Ablation|The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells.|Same Day|Secondary endpoint results were available for 11 subjects. For the secondary results, there were no tumors in four out of 15 samples (26.6%). Therefore, assessment of tumor cannot be made.|||Participants|||Count of Participants
1319040|NCT02323854|Primary|Ablation Zone Shape|Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape|Same day|Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.|||Ratio||Standard Deviation|Mean
1319041|NCT02323854|Primary|Dose Response|Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.|1 Day|Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.|||percent difference||Standard Deviation|Mean
1319042|NCT02323048|Primary|"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire"|"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: “Feel Drug”, “Feel High”, “Like Drug”, and “Want More”. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."|End of study (time 0 and approximately 4 weeks later)||||units on a scale||Standard Deviation|Mean
1319043|NCT02322892|Other Pre-specified|Cellular Oxygen Consumption|Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzers|Post-surgery within 1 hour of arrival to the ICU|||||||
1319044|NCT02322892|Other Pre-specified|Global Oxygen Consumption (VO2)|VO2 will be measured with a Compact Anesthesia monitor|From arrival to ICU to extubation, limit 6 hours|||||||
1319045|NCT02322892|Other Pre-specified|Time on Vasopressors||Limit 60 days|||||||
1319046|NCT02322892|Other Pre-specified|Time on Mechanical Ventilation||Limit 60 days|||||||
1319047|NCT02322892|Other Pre-specified|Pyruvate Dehydrogenase (PDH) Enzyme Activity|PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method|Six hours after end of surgery surgery|||||||
1319048|NCT02322892|Other Pre-specified|Lactate Levels||Six hours after end of surgery surgery|||||||
1319049|NCT02322892|Secondary|Mortality||Until hospital discharge, limit 60 days||||participants|||Number
1319050|NCT02322892|Secondary|Length of Stay|Duration of intensive care unit stay|Until hospital discharge, limit 60 days||||days||Inter-Quartile Range|Median
1319051|NCT02322892|Secondary|Patients With Post-operative Complications|Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection|Until hospital discharge, limit 60 days||||participants|||Number
1319052|NCT02322892|Secondary|Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity|PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery.|Post-surgery within 1 hour of arrival to the ICU||||Percent change from baseline||Inter-Quartile Range|Median
1319053|NCT02322892|Primary|Lactate Levels||Post-surgery within 1 hour of arrival to the ICU|Modified intention to treat|||mmol/L||Inter-Quartile Range|Median
1319054|NCT02322879|Primary|Rise in Plasma Transaminases: Proportion of Responders.|Blood tests to monitor Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) were obtained on every visit prior dosing. ALT and AST were analyzed on a Roche Cobas c501 chemistry module at BIDMC. Responders was defined as peak ALT increased 2x baseline (average of first 3 days)|Daily during the treatment periods (D1-D14 and D29 to 42)||||Participants|||Count of Participants
1319055|NCT02322866|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319137|NCT02320838|Secondary|Habituation to Electrical Stimulation|The habituation to electrical stimulation along experimental session will be measured by recording the difference on current intensity (mA) at the start of the treatment session (1 min) and end of the same (20 min)|Start treatment session (1 min), end treatment session (20 min)|"Sham stimulation arm was not included in the analysis because for the habituation to the current the increased intensity was measured throughout the session and in the Sham group no current was applied"|||mA||Standard Deviation|Mean
1319056|NCT02322866|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319057|NCT02322866|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319058|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
1319059|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
1319060|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
1319061|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
1319077|NCT02322749|Secondary|The PK of the Metabolite N-desmethyl Selumetinib by Assessment of Cmax|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the Cmax of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1319062|NCT02322866|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Scale Success at Week 12|The investigator assessed the participant’s inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Week 12|ITT Population included all randomized participants.|||percentage of participants|||Number
1319063|NCT02322866|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319064|NCT02322788|Primary|Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)||4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods|Efficacy analysis set|||mg/mL||95% Confidence Interval|Least Squares Mean
1319065|NCT02322775|Secondary|Peripheral Blood Eosinophil Levels|"Peripheral blood eosinophil levels assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit.~Changes at Week 12 (respectively at Week 20) were calculated based on patients with both baseline and Week 12 (respectively Week 20)."|Baseline, Week 12 and Week 20|The safety analysis set comprised all patients who received at least one dose of IP. Patients were classified according to the treatment they actually received. A patient who has on one or several occasions received active treatment was classified as active.|||Cells/µL||Full Range|Median
1319066|NCT02322775|Secondary|Serum Concentrations (ng/mL)|Blood samples (processed to serum) for pharmacokinetic assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit. Serum concentrations of benralizumab were determined using a validated electrochemiluminescent (ECL) immunoassay.|Baseline, Week 12 and Week 20|The pharmacokinetic (PK) analysis set comprised all patients who received benralizumab and from whom PK blood samples were obtained are assumed not to be affected by factors such as protocol violations. Those patients who had at least 1 quantifiable serum PK observation post first dose were included in the PK analysis dataset.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1319067|NCT02322775|Secondary|Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12|"The asthma quality of life questionnaire for 12 years and older, AQLQ(S)+12, consists of 32 questions; all assessed on a 7-point scale from 7 to 1, where 7 represents no impairment and 1 represents severe impairment. The 4 individual domain scores (symptoms, activity limitations, emotional function, and environmental stimuli) are the means of the responses to the questions in each of the domains. The overall score is calculated as the mean response to all questions. The changes from baseline of AQLQ(S)+12 score are compared between benralizumab 30 mg Q4W and placebo by using the analyse of covariance (ANCOVA) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL) and region (Europe or North America) as fixed effects and baseline AQLQ(S)+12 score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Deviation|Mean
1319068|NCT02322775|Secondary|Asthma Exacerbations|An asthma exacerbation was defined as a worsening of asthma that led to use of systemic corticosteroids for at least 3 days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids) or an emergency room or urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above) or an inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. Number of patients experiencing an event included in the definition of asthma exacerbation was presented.|Up to Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Patients per number of exacerbations|||Number
1319069|NCT02322775|Secondary|Change From Baseline in Mean ACQ-6 Score at Week 12|"The asthma control questionnaire, ACQ-6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions. The changes from baseline of ACQ-6 score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline ACQ-6 score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Deviation|Mean
1319122|NCT02320838|Secondary|Tactile Threshold Post-treatment 40 Min.|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|at 40 min. post-treatment||||mN||Standard Deviation|Mean
1319123|NCT02320838|Secondary|Tactile Threshold Post-treatment 20 Min.|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|at 20 min. post-treatment||||mN||Standard Deviation|Mean
1319070|NCT02322775|Secondary|Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12|"Nocturnal awakenings due to asthma symptoms and requiring rescue medication use was recorded by the patient in the asthma daily diary each morning. Proportion of nights with nocturnal awakenings was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data for awakening due to asthma. The outcome variable for proportion of nights with nocturnal awakenings was the change from baseline at Week 12 in weekly proportion of nights with nocturnal awakenings. The changes are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline proportion of nights with nocturnal awakenings as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Proportion of nights||Standard Deviation|Mean
1319071|NCT02322775|Secondary|Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12|"The number of rescue medication inhalations and nebulizer treatments taken were recorded by the patient in the asthma daily diary twice daily. The number of inhalations (puffs) per day was calculated as [number of night inhaler puffs] + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times]. The changes from baseline in weekly total asthma rescue medication use (puffs) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma rescue medication use (puffs) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Puffs per day||Standard Deviation|Mean
1319072|NCT02322775|Secondary|Change From Baseline in Total Asthma Symptom Score at Week 12|"Asthma symptoms were recorded by the patient each morning and evening in the asthma daily diary. Symptoms were recorded using a scale of 0-3, where 0 indicates no asthma symptoms. The daily asthma symptom total score was calculated by taking the sum of the daytime score recorded in the evening and the nighttime score recorded the following morning. The weekly total asthma score was averaged from the daily scores over a 7 day period, with score ranging from 0 to 6, where 0 indicates no asthma symptoms. The changes from baseline of weekly total asthma score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Deviation|Mean
1319073|NCT02322775|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of evening PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline evening PEF (L/min) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||L/min||Standard Deviation|Mean
1319074|NCT02322775|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of morning PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline morning PEF (L/min) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||L/min||Standard Deviation|Mean
1319075|NCT02322775|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12|"The FEV1 (L) change from baseline are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) analysis with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline pre-bronchodilator FEV1 (L) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Litre||Standard Deviation|Mean
1319076|NCT02322749|Secondary|The PK of N-desmethyl Selumetinib by Assessment of the AUC(0-t)|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the AUC(0-t) of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319078|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC[0-t] of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319079|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The relative bioavailability of the TPGS capsules variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319080|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the Cmax of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1319081|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319082|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng * hour per mL (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1319083|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the maximum observed plasma concentration (Cmax) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The Pharmacokinetic (PK) analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||nanograms per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1319084|NCT02322528|Primary|Visual Quality|Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.|baseline, 30 minutes, week 1, week 2||||microns||Standard Deviation|Mean
1319085|NCT02322528|Primary|Ocular Surface Temperature of Both Eyes|Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.|baseline, 30 minutes, week 1, week 2||||degrees celcius||Standard Deviation|Mean
1319086|NCT02322229|Secondary|Change From Baseline in Central Foveal Thickness at Days 28 and 180|Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 180|Missing data is imputed using the LOCF method. CFT values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy.|||Microns||Standard Deviation|Mean
1319087|NCT02322229|Secondary|Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180|Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. One eye (study eye) contributed to the analysis.|Day 180|Full Analysis Set|||percentage of subjects|||Number
1319088|NCT02322229|Secondary|Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180|As described in Primary Outcome Measure|Baseline (Day 0), Day 7, Day 90, Day 180|Full Analysis Set. Missing data imputed for Days 90 and 180 using the LOCF method. Subjects who had vitrectomy are considered as 'no VMA resolution' after the timepoint of vitrectomy.|||percentage of subjects|||Number
1319089|NCT02322229|Secondary|Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)|The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. One eye (study eye) contributed to the analysis.|Day 7, Day 28, Day 90, Day 180|This analysis population includes all subjects in Full Analysis Set with MH at baseline (n=4). Subjects who had vitrectomy after MH closure are considered as 'no MH closure' after the timepoint of vitrectomy.|||percentage of subjects|||Number
1319090|NCT02322229|Secondary|Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180|BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using the LOCF method. BCVA values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy.|||letters||Standard Deviation|Mean
1319091|NCT02322229|Primary|Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD‐OCT) Evaluation|Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. One eye (study eye) contributed to the analysis.|Day 28|Full Analysis Set. Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMA resolution are considered as 'no VMA resolution' after timepoint of vitrectomy.|||percentage of subjects|||Number
1319092|NCT02322216|Primary|Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14|Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.|Baseline, Day 14|Per Protocol Set with non-missing data|||units on a scale||Standard Error|Mean
1319093|NCT02321527|Primary|Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique|Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contrast will be employed up to three times. If no contrast enhancement in lymphatics is observed, the case will be reported as a failure of the CEUS technique.|1 day||||Participants|||Count of Participants
1319094|NCT02321436|Secondary|Mean Duration of Concomitant Non-drug Therapy Sessions.|The duration of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject’s last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). Overall duration of concomitant therapies in the indication of “Post Stroke UL Spasticity” was computed for the period from first administration of Dysport® or placebo to last study visit. Concomitant non–drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.|From baseline up to Week 28|This analysis was performed on the safety population which includes all randomised subjects who received the study medication.|||days||Standard Deviation|Mean
1319095|NCT02321436|Secondary|Number of Concomitant Non-drug Therapy Sessions.|The number of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject’s last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). All concomitant therapies in the indication of “Post Stroke UL Spasticity” were counted by subject from first administration of Dysport® or placebo to last study visit. Concomitant non–drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.|From baseline up to Week 28|This analysis was performed on the safety population which includes all randomised subjects who received the study medication.|||Number of sessions|||Number
1319096|NCT02321436|Secondary|Global Assessment of Changes at Last Visit|"Global assessment of changes was assessed by the investigator from Week 4 up to (but not including) the visit when the reinjection criteria were met. This endpoint was assessed by the investigator using a 5-point Likert scale to answer the following question: How does your patient feel compared to his/her condition at the first visit?~Much better~Better~No change~Worse~Much worse~Results are reported overall for subjects with both symptomatic and asymptomatic spasticity."|From Week 4 up to Week 28|This efficacy analysis was performed on the ITT population which includes all randomised subjects who provided informed consent. No data is available for subjects who met their reinjection criteria at Visit 2 (Week 4).|||percentage of participants|||Number
1319124|NCT02320838|Secondary|Baseline Tactile Threshold|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|Baseline at 0 min.||||mN||Standard Deviation|Mean
1319125|NCT02320838|Secondary|Nerve Conduction Latency Post-treatment 40 Min.|The compound action potential latencies will be measured and will be expressed in ms.|at 40 min. post-treatment||||ms||Standard Deviation|Mean
1319097|NCT02321436|Secondary|Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.|"The Fugl-Meyer assessment is a validated tool for measuring motor functioning, balance, sensation, and joint functioning in the upper or lower limbs of subjects with post-stroke hemiplegia. The assessment scale is comprised of 155 items across 5 domains: motor functioning, sensory functioning, balance, joint range of motion and joint pain. For this study, only the UL motor part was assessed using the following criteria:~A. Upper Extremity (from 0 to 36) B. Wrist (from 0 to 10) C. Hand (from 0 to 14) D. Coordination / Speed (from 0 to 6)~Total motor function scores (A-D [from 0 to 66]) were calculated and LS mean changes from baseline up to (but not including) the visit when the reinjection criteria were met were reported.~Higher values for change from baseline indicated a better outcome."|From baseline up to Week 28|This analysis was performed on the ITT population and includes all randomised subjects who provided informed consent.|||units on a scale||Standard Error|Least Squares Mean
1319098|NCT02321436|Secondary|Mean Change in MAS of the Primary Targeted Muscle Group.|Increased muscle tone in the primary muscle group (selected by the investigator at the first visit, based on his/her clinical judgement and in agreement with the subject, in one of the following muscle groups: elbow flexors or pronators, wrist flexors, or finger flexors) was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Least Squares (LS) mean change from baseline to each subsequent visit (including the subject’s last study visit) of the MAS score is reported.|From baseline up to Week 28|This analysis was performed on the ITT population which includes all randomised subjects who provided informed consent.|||units on a scale||Standard Error|Least Squares Mean
1319099|NCT02321436|Primary|Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms|"The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 [no increase in muscle tone] to 4 [affected part rigid in flexion or extension]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL:~A Numeric Pain Rating Scale (NPRS) pain score ≥ 4 (NPRS ranges from 0 [no pain] to 10 [severe pain])~An impact on passive function measured by a score of ≥ 1 on the 4-point Likert scale (scale ranges from 0 [no impact] to 3 [severe impact])~An impact on active function measured by a score of ≥ 1 on the 4-point Likert scale~An involuntary movements score ≥1 on the 4-point Likert scale in relevant upper limb.~Results are reported overall for subjects with both symptomatic and asymptomatic spasticity."|From Week 4 up to Week 28|This analysis was performed on the Intention-To-Treat (ITT) population which includes all randomised subjects who provided informed consent.|||days||95% Confidence Interval|Median
1319100|NCT02320903|Secondary|Loeber Parental Knowledge Scale|Youth report of how much parents actually know about the youth's whereabouts/activities. This 5-item scale has a scored range of 0 (minimum score) - 15 (maximum score), with high scores indicating that the parent knows more about what teens are actually doing.|over 30 days of app usage|Youth/teens who used app only|||units on a scale||Standard Deviation|Mean
1319101|NCT02320903|Secondary|Parental Locus of Control Scale|Degree to which parents feel efficacious and confident in managing parenting challenges. This 20-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating that the parent has a higher sense of feeling efficacious in their role as a parent.|Change over 30 days of app usage (baseline to post-assessment)|All parents/caregivers who completed the study.|||units on a scale||Standard Deviation|Mean
1319102|NCT02320903|Secondary|Perceived Stress Scale (PSS)|Degree to which parents are experiencing stress related to parenting. This 10-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating more stress related to parenting.|Change over 30 days of app usage (baseline to post-assessment)|All parents/caregivers who completed the study.|||units on a scale||Standard Deviation|Mean
1319103|NCT02320903|Secondary|Loeber Parental Effectiveness Scale|"Degree to which parents feel that their parenting techniques are working in terms of managing teen behavior challenges. This 3-item scale has a scored range of 0 (minimum score) - 8 (maximum score), with high scores indicating better discipline effectiveness (e.g., I feel like the punishment I give works in curbing youth behavior)."|Change over 30 days of app usage (baseline to post-assessment)|All parents/caregivers who completed the study.|||units on a scale||Standard Deviation|Mean
1319104|NCT02320903|Secondary|Loeber Parental Consistency Scale|This measure of extent to which parents are consistent in their rules, expectations, and discipline techniques with youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage. This 5-item scale has a scored range of 0 (minimum score) - 10 (maximum score), with high scores indicating more consistent / better parental discipline follow-through.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
1319105|NCT02320903|Secondary|Loeber Positive Parenting Scale|This measure of extent to which parents express warmth and encouragement to youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 9-item scale has a scored range of 0 (minimum score) - 18 (maximum score), with high scores indicating more parental positivity.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
1319106|NCT02320903|Secondary|Loeber Parental Supervision Scale|This measure of extent to which parents supervise and monitor youth whereabouts was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 8-item scale has a scored range of 0 (minimum score) - 16 (maximum score), with high scores indicating more or better parental supervision/monitoring.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
1319126|NCT02320838|Secondary|Nerve Conduction Latency Post-treatment 20 Min.|The compound action potential latencies will be measured and will be expressed in ms.|at 20 min. post-treatment||||ms||Standard Deviation|Mean
1319127|NCT02320838|Secondary|Baseline Nerve Conduction Latency|The compound action potential latencies will be measured and will be expressed in ms.|Baseline at 0 min.||||ms||Standard Deviation|Mean
1319128|NCT02320838|Secondary|Thermal Pain Threshold Post-treatment 40 Min.|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|at 40 min. post-treatment||||ºC||Standard Deviation|Mean
1319107|NCT02320903|Secondary|Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale|The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the rule-breaking subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 34; a score of 9 or higher indicates clinically significant rule-breaking, defined as rule-breaking that is higher than that of 93% of teens in the United States.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
1319108|NCT02320903|Secondary|Achenbach System of Empirically-Based Assessment, Depression Subscale|The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the depression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 26; a score of 8 or higher indicates clinically significant depression, defined as depressive symptoms higher than that of 93% of teens in the United States.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately. Least squares means show amount of difference from pre- to post-testing in paired samples T tests.|||units on a scale||Standard Deviation|Mean
1319109|NCT02320903|Secondary|Achenbach System of Empirically-Based Assessment, Aggression Subscale|The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the aggression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 36; a score of 13 or higher indicates clinically significant aggression, defined as aggression that is higher than that of 93% of teens in the United States.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
1319110|NCT02320903|Primary|App Satisfaction - I Like Getting Prompts and Reminders|"Youth/teens in the study were prompted 3 times/week during period of app usage to rate, on a scale of 1 (strongly disagree) to 7 (strongly agree), I like getting prompts and reminders from the app."|up to 45 days|Only teens were provided with this question.|||units on a scale||Standard Deviation|Mean
1319111|NCT02320903|Primary|App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior|Three times each week, at random, youth/teens were asked to rate on a scale of 1 (strongly disagree) to 7 (strongly agree), my parent is noticing and rewarding good behavior. All ratings were averaged across full period of app use.|up to 45 days|Only youth/teens were provided this question.|||units on a scale||Standard Deviation|Mean
1319112|NCT02320903|Primary|App Satisfaction Rating - Overall Satisfaction|Parent/caregiver and teen was prompted randomly 3 times each week to rate on a scale of 1 (totally unsatisfied) to 7 (completely satisfied), overall, how satisfied are you with the app today?|up to 45 days|Parent/caregiver and teen participants were analyzed separately on this measure.|||units on a scale||Standard Deviation|Mean
1319113|NCT02320903|Primary|App Satisfaction Rating - I Have Ways to Intervene With my Teen.|Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), the app gives me new ways of intervening with my teen.|up to 45 days|Only parent/caregivers were given this question.|||units on a scale||Standard Deviation|Mean
1319114|NCT02320903|Primary|App Satisfaction Rating - the App Was Helpful Today|Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), how helpful was the app to you today?|up to 45 days|Only parent/caregivers were administered this measure.|||units on a scale||Standard Deviation|Mean
1319115|NCT02320903|Primary|App Usage - View Progress Graph (Points Earned Over Time)|Youth/teen points earned over time were depicted on a graph for each day of use. To view the graph, caregivers/parents and youth/teens had to click on an app button.|up to 45 days|Analyses performed separately for parents and teens.|||Participants|||Count of Participants
1319116|NCT02320903|Primary|App Usage - Viewed Parent Coaching Videos|The app included 5 brief video vignettes depicting an effective parenting technique.|up to 45 days|Only the parent/caregiver version of the app had this feature.|||Participants|||Count of Participants
1319117|NCT02320903|Primary|App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met|The percentage of participants who viewed notifications that the teen was or was not meeting a behavioral expectation. Both parents and teens had this capability.|up to 45 days|All parent/caregiver and teen participants analyzed|||Participants|||Count of Participants
1319118|NCT02320903|Primary|App Usage - Parent Set Geolocation Expectations for the Teen.|Percentage of parent/caregivers who set either required or off-limits locations for their teens.|up to 45-days||||Participants|||Count of Participants
1319119|NCT02320903|Primary|App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior|How many parents/caregivers set up a reward system and redeemed at least some points for the teen.|up to 45-days|Percent of caregivers who set and allocated points to the teen (teens who had points redeemed).|||Participants|||Count of Participants
1319120|NCT02320903|Primary|App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen|Percent of parents who set up a behavior plan for teen using app features.|up to 45-days|All parent/caregiver and teen participants analyzed.|||Participants|||Count of Participants
1319121|NCT02320838|Other Pre-specified|Skin Temperature|Skin temperature (ºC) will be recorded in all assessment times.|Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment||||ºC||Standard Deviation|Mean
1329620|NCT02107014|Primary|Change in IL-2 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1319142|NCT02320721|Post-Hoc|Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population.|||events per participant year|||Number
1319143|NCT02320721|Other Pre-specified|Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population.|||events per participant year|||Number
1319144|NCT02320721|Other Pre-specified|Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population included all randomized participants who actually received at least 1 dose or part of a dose of investigational medicinal product (IMP) and analyzed according to the treatment actually received.|||percentage of participants|||Number
1319145|NCT02320721|Secondary|Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
1319146|NCT02320721|Secondary|Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26|WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).|Baseline, Week 26|ITT population. Here ‘Overall number of participants analyzed’ signifies participants with available data for this outcome measure.|||scores on a scale||Standard Error|Least Squares Mean
1319147|NCT02320721|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.|Baseline, Week 26|ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure.|||mmol/L||Standard Error|Least Squares Mean
1319148|NCT02320721|Secondary|Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period|Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
1319149|NCT02320721|Secondary|Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period|Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
1319150|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
1319151|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
1319152|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
1319153|NCT02320721|Primary|Change in HbA1c From Baseline to Week 26|Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.|Baseline, Week 26|Intent-to-treat (ITT) population included all randomized participants regardless of whether the treatment kit was used, and analyzed according to the treatment group allocated by randomization.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1319154|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 8|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 8|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.|||units on a scale||Standard Deviation|Mean
1319155|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 1|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 1|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.|||units on a scale||Standard Deviation|Mean
1319156|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and one minute after investigational product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation at one minute after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to one minute after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.|||units on a scale||Standard Deviation|Mean
1319157|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and immediately after product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation immediately after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to immediately after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.|||units on a scale||Standard Deviation|Mean
1319158|NCT02320487|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.|Day 1 up to 36 months|The safety population included participants who received any amount of study treatment.|||percentage of participants|||Number
1319159|NCT02320487|Secondary|Number of Hospitalizations Due to Adverse Events (AEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.|Day 1 up to 36 months|The safety population included participants who received any amount of study treatment.|||hospitalizations||Standard Deviation|Mean
1319160|NCT02320487|Secondary|Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score|The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) module included assessments of fatigue, treatment side effects, disease symptoms, infection, social activities, and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.|Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 36 months) (1 cycle = 28 days)|The PRO Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.|||score on a scale||Standard Deviation|Mean
1319161|NCT02320487|Secondary|Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score|The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.|Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 36 months) (1 cycle = 28 days)|The PRO (patient-reported outcome) Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.|||score on a scale||Standard Deviation|Mean
1319162|NCT02320487|Secondary|Ctrough of Obinutuzumab After Cycle 4|Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.|Pre-infusion (0 hours) on Day 1 Cycle 5 (1 cycle = 28 days)|The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1319163|NCT02320487|Secondary|Minimum Observed Concentration (Ctrough) of Obinutuzumab After Cycle 2|Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.|Pre-infusion (0 hours) on Day 1 Cycle 3 (1 cycle = 28 days)|The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1319164|NCT02320487|Secondary|Duration of MRD-Negativity in Peripheral Blood Among Participants Who Achieved MRD-Negative Status|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.|Baseline up to 36 months|The ITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.|||months||95% Confidence Interval|Median
1319165|NCT02320487|Secondary|Time to MRD-Negative Status in Peripheral Blood|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.|Baseline up to 36 months|The ITT population included enrolled participants who received at least one dose of BG.|||months||95% Confidence Interval|Median
1319166|NCT02320487|Secondary|Percentage of Participants Who Achieved MRD-Negative Status in Peripheral Blood|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.|Baseline up to 36 months|The ITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.|||percentage of participants||95% Confidence Interval|Number
1319167|NCT02320487|Secondary|Percentage of Participants Who Achieved Minimal Residual Disease (MRD)-Negative Status in Bone Marrow|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in bone marrow aspirate. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.|Up to 36 months|The ITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.|||percentage of participants||95% Confidence Interval|Number
1319168|NCT02320487|Secondary|Overall Survival (OS)|OS was defined as the time from the start of induction treatment to death from any cause. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.|Day 1 until death from any cause (up to 36 months)|The ITT population included enrolled participants who received at least one dose of BG.|||months||95% Confidence Interval|Median
1319169|NCT02320487|Secondary|Progression-Free Survival (PFS), as Determined by the Investigator Using iwCLL NCI-WG Guidelines|PFS was defined as the time from the start of induction treatment (Day 1) to the first occurrence of disease progression, relapse as determined by the investigator using iwCLL NCI WG guidelines, or death (within 28 days after the last dose of study drug), whichever occurred first. Disease progression: at least one of the following: lymphadenopathy; increase in the liver or spleen size by 50% or more or the appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. Relapse: Having achieved CR or PR, but after a period of 6 or more months, having demonstrated evidence of disease progression. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.|Day 1 until disease progression, relapse, or death from any cause, whichever occurred first (up to 36 months)|The ITT population included enrolled participants who received at least one dose of BG.|||months||95% Confidence Interval|Median
1319170|NCT02320487|Secondary|Duration of Response Among Participants With Objective Response of CR or PR, as Determined by the Investigator Using iwCLL NCI-WG Guidelines|Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nodular partial response (nPR) to the first documentation of PD or death, whichever occurred first. CR, CRi, and PR are identified in previous outcome measures. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. Participants with post-baseline response assessments (excluding progressive disease) but with no end-of-induction treatment response available were censored on Day 1, and those with end-of-induction treatment response available but who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.|From the first assessment of CR, CRi, PR, or nPR (at up to approximately 228 to 258 days) until disease progression, relapse, or death from any cause, whichever occurred first (up to 36 months)|The ITT population included enrolled participants who received at least one dose of BG. Analysis performed for participants with response.|||months||95% Confidence Interval|Median
1319171|NCT02320487|Secondary|Percentage of Participants With Objective Response of CR or Partial Response (PR) at the End of Induction Therapy, as Determined by the Investigator Using iwCLL NCI-WG Guidelines|CR is defined in the previous outcome measure. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline.|2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)|The ITT population included enrolled participants who received at least one dose of BG.|||percentage of participants||95% Confidence Interval|Number
1319172|NCT02320487|Primary|Percentage of Participants With Complete Response (CR), as Determined by the Investigator Using International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) Guidelines|The CR rate was defined as CR or CR with incomplete blood count recovery (CRi), assessed by the investigator according to iwCLL NCI-WG criteria. The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi.|2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)|The intent-to-treat (ITT) population included enrolled participants who received at least one dose of BG.|||percentage of participants||95% Confidence Interval|Number
1319233|NCT02319148|Secondary|Terminal Elimination Half-Life (t1/2) of PF-00489791|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hour||Standard Deviation|Mean
1319173|NCT02320396|Secondary|Percentage of Participants With Impression Assessments of “Better” or “Much Better” as Assessed Participants at Week 2|The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The percentage of participants with assessments of “Better” and “Much better” graded by the participant (Participant’s Impression Rate) was reported and analyzed using Odds Ratio analysis.|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.|||percentage of participants|||Number
1319174|NCT02320396|Secondary|Percentage of Participants With Impression Assessments of “Better” or “Much Better” as Assessed by the Investigator at Week 2|The investigator assessed the participant’s symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant’s symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The evaluation result and reason for judgment (if needed) was recorded in the participant’s case report form. The investigator’s impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant’s own impression at Week 2. The percentage of participants with assessments of “Better” and “Much better” graded by the investigator (Investigator’s Impression Rate) was reported and analyzed using Odds Ratio analysis.|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.|||percentage of participants|||Number
1319175|NCT02320396|Secondary|Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy|Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible. Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319176|NCT02320396|Secondary|Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319177|NCT02320396|Secondary|Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 8 to 13 (Week 2) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319178|NCT02320396|Secondary|Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant’s diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319237|NCT02319148|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
1319179|NCT02320396|Secondary|Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319180|NCT02320396|Secondary|Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319181|NCT02320396|Secondary|Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|Nasal symptoms sub-scores rated in the participant’s diary included sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319182|NCT02320396|Secondary|Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment|The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant’s diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1319183|NCT02320396|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.|Up to 2 weeks|APaT; all participants who received ≥1 dose of study treatment.|||participants|||Number
1319184|NCT02320396|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor’s product, was also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|All Participants as Treated (APaT); all participants who received ≥1 dose of study treatment.|||participants|||Number
1319238|NCT02319148|Primary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1319185|NCT02320396|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy|The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or “none”] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or “none”] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant’s diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement – BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The Full Analysis Set (FAS); all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation (average score of 2 weeks).|||units on a scale||95% Confidence Interval|Least Squares Mean
1319186|NCT02320227|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 days||||participants|||Number
1319187|NCT02320227|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed local erythema by OB/GYN examination.|14 Days||||participants|||Number
1319188|NCT02320214|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 Days|female only|||participants|||Number
1319189|NCT02320214|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed erythema by OB/GYN examination.|14 Days|female only|||participants|||Number
1319190|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319191|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319192|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319193|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319194|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319195|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319196|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319197|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319198|NCT02320149|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319199|NCT02320149|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Weeks 6|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319200|NCT02320149|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319201|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319202|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319234|NCT02319148|Secondary|Apparent Oral Clearance (CL/F) of PF-00489791|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1319203|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319204|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
1319205|NCT02320149|Primary|Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12|The investigator assessed the participant’s inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||percentage of participants|||Number
1319206|NCT02320149|Primary|Absolute Change in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
1319207|NCT02319824|Secondary|Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers|Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative.|Up to 6 weeks post-treatment||||Participants|||Count of Participants
1319208|NCT02319824|Secondary|T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1|RECIST at 6 weeks after treatment (non-radiated tumors only)|At 6 weeks post-treatment||||Participants|||Count of Participants
1319209|NCT02319824|Primary|Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03|CTCAE v4.03|Up to 12 weeks post-treatment|treated patients|||participants|||Number
1319210|NCT02319668|Secondary|Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis|Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation|At Baseline|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||log (10) CFU/mL||Standard Deviation|Mean
1319211|NCT02319668|Secondary|Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery|Up to 7 days post implant surgery|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||log (10) CFE × Day||Standard Deviation|Mean
1319235|NCT02319148|Secondary|Apparent Volume of Distribution (Vz/F) of PF-00489791|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||liter||Geometric Coefficient of Variation|Geometric Mean
1319212|NCT02319668|Secondary|Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.|At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. n was number of participants evaluated at specific endpoint.|||log (10) CFE||Standard Deviation|Mean
1319213|NCT02319668|Primary|Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant.|At Day 3|Intent to treat (ITT) population (N=38): defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||log(10) colony forming equivalents (CFE)||Standard Deviation|Mean
1319214|NCT02319525|Secondary|Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement)|"Feasibility of the decision-aid vs. pamphlet was assessed using a single statement The education guide was easy to use. Patients rated this on 5-point ordinal scale ranging from “strongly agree” to “strongly disagree” (response options were: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The number of patients was compared between the two treatment arms."|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|One patient from pamphlet group did not respond to this question, therefore valid responses from pamphlet were 146, not 147|||Participants|||Count of Participants
1319215|NCT02319525|Secondary|"Acceptability (Number of Participants Rating Each Statement as Excellent)"|"Acceptability of the decision-aid (information quality and quantity, presentation style and usefulness) was assessed using a validated acceptability survey on 4-point scale ranging from “excellent” to “poor” (response options were: excellent, good, fair and poor). The number of patients rating each of the five statements as excellent (vs. other ratings) was compared between the two treatment arms."|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)||||Participants|||Count of Participants
1319216|NCT02319525|Secondary|Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication|This was done by analyzing the audio-recorded patient-physician discussion in patients with current lupus nephritis flare. The APCC is a validated instrument to measure ‘active patient participation.’ APCC assesses indicators and facilitators of patient participation. The unit of coding is the utterance, the oral analogue of a sentence. The range is 0 to unlimited. Patient participation is measured by the number of questions, number of concerns expressed, and act of assertiveness (e.g., preferences, introducing topics, making requests). These are ‘active’ forms of participation because of their influence on clinician behavior and the structure and content of the consultation. The APPC also assess clinician behaviors that facilitate and support patient participation, partnership-building and supportive talk (e.g., reassurance, empathy). We present doctor patient-centered communication. higher scores indicates better patient participation and communication.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication, who also agreed for an audio-recorded conversation.|||units on a scale||Standard Deviation|Mean
1319217|NCT02319525|Secondary|Patient Physician Communication (Interpersonal Processes of Care (IPC)|This was assessed using the interpersonal processes of care (IPC), an 18-item validated patient-reported measure of patient-physician communication and care processes. The score ranges from 18 (worst) to 90 (best) and the scale is a patient-reported measure of patient-physician communication and care processes.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.|||units on a scale||Standard Deviation|Mean
1319218|NCT02319525|Secondary|Control Preferences Scale: Patient Participation in Decision-making|This scale assessed how much decision-making control they would like to have versus actually experienced. There are 5 responses for 5 control options: active, active shared, collaborative, passive shared and passive, which were collapsed into active (active, active shared), collaborative, and passive (passive shared and passive), as previously (and pre-specified). Concordance was assessed between desired and actual role played by each patient. We present these data for patients with current flare only, since only they were making a decision about the immunosuppressive drugs; patients with past lupus flare were not included in the denominator.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication.|||participants|||Number
1319236|NCT02319148|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hour||Full Range|Median
1329621|NCT02107014|Primary|Change in IL-1Ra From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1319219|NCT02319525|Primary|Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)|Concordance between values related (for or against starting) immunosuppressive drugs with patients’ decision (to start or not start) immunosuppressive drugs, in those with adequate knowledge about benefits/harms of immunosuppressive drugs, assessed using validated instruments for values regarding immunosuppressive drugs, knowledge about immunosuppressive drugs, and treatment decision-making (patient’s decision to start immunosuppressive drug).|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.|||participants|||Number
1319220|NCT02319525|Primary|Change From Baseline in Decisional Conflict Scale Scores|Patient self-administered, validated measure of decisional conflict, most commonly used as the primary outcome in RCTs of decision aids (change score). The score ranges from 0 (no decisional conflict) to 100 (extreme decisional conflict). Decisional conflict represents a state of uncertainty about a choice or course of action and is more likely in situations involving high-stakes choices with important potential gains and losses, value tradeoffs in selecting a choice or a course of action (vs. the alternative) or uncertain outcomes.|Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet|||units on a scale||Standard Deviation|Mean
1319221|NCT02319486|Primary|Event Free Survival Rate|measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis|18 months||||participants|||Number
1319222|NCT02319317|Secondary|Driving Citations and Crashes|Difference between the intervention and control group on driving citations and crashes.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).|||||||
1319223|NCT02319317|Secondary|Self-report Driving Behaviors|Difference between the intervention and control group on self-report measures of driving behaviors.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).|||||||
1319224|NCT02319317|Secondary|Simulated Driving Performance|Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).|Baseline (Study Visit 1) through Study Visit 3|||||||
1319225|NCT02319317|Secondary|Adherence|Adherence among the intervention and control group to the intervention.|Baseline (Study Visit 1) through completion of the intervention.|||||||
1319226|NCT02319317|Secondary|Proportion of Participants Randomized|Proportion of participants screened, enrolled and randomized|Baseline (Study Visit 1)|||||||
1319227|NCT02319317|Primary|Retention of Participants|Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).||||Participants|||Count of Participants
1319228|NCT02319148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.|||participants|||Number
1319229|NCT02319148|Secondary|Number of Participants Who Used at Least 1 Concomitant Medication|Participants were to abstain from all concomitant treatments, except for the treatment of AEs. Treatments taken after the first dose of study treatment were documented as concomitant treatments.|Baseline up to Day 15 (final study evaluation)|The safety analysis population included all participants who received the study medication.|||participants|||Number
1319230|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.|||participants|||Number
1319231|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to Day 9|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.|||participants|||Number
1319232|NCT02319148|Secondary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.|||participants|||Number
1319239|NCT02319148|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The pharmacokinetic (PK) analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1319240|NCT02319044|Secondary|Duration of Response|Duration of objective response in patients with objective response based on BICR assessments according to RECIST v1.1. Duration of response was the time from the first documentation of Complete response/Partial response (which was subsequently confirmed) until the date of progression, death, or the last evaluable RECIST assessment for patients that did not progress. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off (per RECIST v1.1 as assessed by BICR).|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||Participants|||Number
1319241|NCT02319044|Secondary|Quality of Life|Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires: -The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3. -Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H&N35. The symptom and QoL/function improvement rate was defined as the number (%) of patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10 or EORTC QLQ-C30 scales) in that symptom/function from baseline. For QLQ-H&N35A a minimum clinically meaningful change was defined as a change in the score from baseline of >10 for scales/items|After 12 months|Full analysis set - all randomized patients|||% patients||95% Confidence Interval|Number
1319242|NCT02319044|Secondary|Overall Survival|Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status or patients who were lost to follow-up.|After 12 months|Full analysis set - all randomized patients|||% participants|||Number
1319243|NCT02319044|Secondary|Progression-free Survival (PFS)|Progression status at 12 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.|After 12 months|Full analysis set - all randomized patients|||% participants|||Number
1319244|NCT02319044|Secondary|Progression-free Survival (PFS)|Progression status at 6 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.|After 6 months|Full analysis set - all randomized patients|||% participants|||Number
1319245|NCT02319044|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR) at 12 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
1319246|NCT02319044|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR) at 6 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.|After 6 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
1319247|NCT02319044|Secondary|Time to Onset of Response From First Dose|Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||Months||Full Range|Median
1319248|NCT02319044|Secondary|Time to Response|Time to response in patients with objective response based on BICR assessments according to RECIST 1.1|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
1319249|NCT02319044|Secondary|Duration of Response - Participants Remaining in Response|Participants remaining in response - based on BICR assessments according to RECIST v1.1. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off.|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
1319250|NCT02319044|Secondary|Best Objective Response|The best response a patient has had during their time in the study|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
1319433|NCT02316366|Primary|Rate of Hospital Admission|After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.|4 hours||||percentage of participants||95% Confidence Interval|Number
1319251|NCT02319044|Primary|Objective Response Rate at 12 Months|Objective response rate (per RECIST 1.1 as assessed by blinded independent central review [BICR]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. criteria are: Complete response [CR] = disappearance of all target lesions since baseline; and partial response [PR] = at least a 30% decrease in the sum of the diameters of target lesions.|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants||95% Confidence Interval|Number
1319252|NCT02319044|Primary|Objective Response Rate at 6 Months|Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses|After 6 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants||95% Confidence Interval|Number
1319253|NCT02319031|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities|Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.|Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)|All treated participants: Enrolled participants who received at least 1 dose of study drug|||participants|||Number
1319254|NCT02319031|Secondary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)|SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Weeks 4 and 24|All treated participants: Enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1319255|NCT02319031|Primary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)|SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Week 12|All treated participants: Enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1319256|NCT02319005|Secondary|All-cause Mortality|Total number of deaths in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319257|NCT02319005|Secondary|Cardiovascular (CV) Hospitalization|Number of cardiovascular-related hospitalizations in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319258|NCT02319005|Secondary|Cardiovascular (CV) Mortality|Number of cardiovascular-related deaths in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319259|NCT02319005|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The difference between revusiran (ALN-TTRSC) and placebo group in the change from Baseline to 18 months in the Kansas City Cardiomyopathy Questionnaire|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319260|NCT02319005|Secondary|New York Heart Association (NYHA) Class|The difference between revusiran (ALN-TTRSC) and placebo group in the change from baseline to 18 months in the NYHA class|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319261|NCT02319005|Secondary|Composite Cardiovascular (CV) Mortality and Cardiovascular (CV) Hospitalization|Number of cardiovascular-related deaths and cardiovascular-related hospitalizations in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319262|NCT02319005|Primary|Serum TTR Levels|The difference between revusiran (ALN-TTRSC) and placebo group in the percent reduction in serum TTR levels over 18 months|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319497|NCT02313766|Primary|Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%|Time measured form face mask positioning until FEO2 reached 90% on the gas monitor|up to 5 min||||seconds||Inter-Quartile Range|Median
1319263|NCT02319005|Primary|6 Minute Walk Distance (6-MWD)|The difference between revusiran and placebo group in change from baseline to 18 months in the total distance walked in 6 minutes|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
1319264|NCT02318940|Secondary|Arterial Puncture|Percentage of participants with Arterial puncture aspiration|intraoperative, an average of 1 hour||||percentage of participants|||Number
1319265|NCT02318940|Secondary|Number of Attempts|Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts.|intraoperative, an average of 1 hour||||participants|||Number
1319266|NCT02318940|Secondary|Successful Installation|Percentage of participants with successful installation of guide without difficulty in the femoral vein|intraoperative, an average of 1 hour||||percentage of participants|||Number
1319267|NCT02318940|Primary|Installation on the First Try|Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle|intraoperative, an average of 1 hour||||percentage of participants|||Number
1319268|NCT02318797|Secondary|Change in Lab Monitoring - EKG|Frequency of EKG tests in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of EKG tests in 12 mo. period||Standard Deviation|Mean
1319269|NCT02318797|Secondary|Change in Lab Monitoring - Lipids|Frequency of lipid lab tests in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of lab tests in 12 mo. period||Standard Deviation|Mean
1319270|NCT02318797|Secondary|Change in Lab Monitoring - Glucose|Frequency of glucose lab tests in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of lab tests in 12 mo. period||Standard Deviation|Mean
1319271|NCT02318797|Secondary|Change in Medication Adherence - Antidepressants|Claims data used to calculate antidepressant medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill – last_end_Date) > 180 then MPR = (total days supply – (first_fill – last_end_Date) – 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed am antidepressant medication.|||Medication possession ratio||Standard Deviation|Mean
1319272|NCT02318797|Secondary|Change in Medication Adherence - Hypertension|Claims data used to calculate antihypertensive medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill – last_end_Date) > 180 then MPR = (total days supply – (first_fill – last_end_Date) – 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed a antihypertensive medication.|||Medication possession ratio||Standard Deviation|Mean
1319273|NCT02318797|Secondary|Change in Medication Adherence - Antipsychotics|Claims data used to calculate antipsychotic medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill – last_end_Date) > 180 then MPR = (total days supply – (first_fill – last_end_Date) – 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed a antipsychotic medication.|||Medication possession ratio||Standard Deviation|Mean
1319274|NCT02318797|Secondary|Change in Patient Satisfaction With Care|Change in patient satisfaction with care was assessed using the Patient Assessment of Care for Chronic Conditions (PACIC). Each item of the PACIC is on a 1 to 5 scale. The total score is the average of all 20 item scores. Higher scores represent increased frequency of structured chronic care.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
1319275|NCT02318797|Secondary|Change in Lab Monitoring - Overall|Frequency of lab tests (glucose, lipids, EKG) in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of lab tests in 12 mo. period||Standard Deviation|Mean
1319276|NCT02318797|Secondary|Change in Emergent Care Use (Claims Data)|Behavioral and physical health claims data will be obtained to determine frequency of emergent service use for participants over 12-month time periods.|Updated annually using claims data over 2 year active intervention period|# of individuals with 80% Medicaid eligibility in the 12 months prior to the data collection time point.|||frequency of visits in 12-month periods||Standard Deviation|Mean
1319277|NCT02318797|Secondary|Change in Functional Status (Sheehan Disability Scale)|Functional status is measured using the Sheehan Disability Scale which assesses functional impairment in three domains including: work/school, social and family life. Respondents rate the extent to which work/school, social life and home life or family responsibilities are impaired by symptoms. The three items from the Sheehan Disability Scale are summed together into a single measure of global functional impairment. This measure ranges from 0 to 30, with 0 being unimpaired and 30 being highly impaired.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
1319278|NCT02318797|Secondary|Change in Medication Adherence - Diabetes|Claims data used to calculate diabetes medication possession ratio (MPO) for participants diagnosed with diabetes in 6 month time periods. If the (first_fill – last_end_Date) > 180 then MPR = (total days supply – (first_fill – last_end_Date) – 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed a diabetes medication.|||Medication possession ratio||Standard Deviation|Mean
1319279|NCT02318797|Secondary|Change in Quality of Life (QLESQ)|Patient quality of life is measured using the QLESQ (Quality of Life Enjoyment and Satisfaction Questionnaire) in which participants respond on a scale of 1 (very poor) to 5 (very good) their level of satisfaction with a variety of social and physical domains. The total raw score ranges from 14 to 70 or 0-100%. Only the first 14 items yield the raw total score as the last two items are standalone. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score). The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. The information below reflects raw scores (rather than percentages).|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
1319280|NCT02318797|Secondary|Change in Hope (Hope Scale)|Assessed using the Hope Scale, an instrument designed to measure hope that has been previously used in health services research. Twelve items are rated on a four-point response scale ranging from “definitely false” to “definitely true” and summed to produce a total score. The hope scale ranges from 1 to 10, with 1 being no hope and 10 being filled with hope.|Baseline and every 6 months during the active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
1319281|NCT02318797|Primary|Change in Health Status ( SF-12v2™): Mental Health Sub-scale|Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The mental health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains (reverse of the weighting used for the physical health component summary score). Scores range from 0-100 and better mental health is indicated by a higher score.|Baseline and every 6 months during the active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||units on a scale||Standard Deviation|Mean
1319282|NCT02318797|Primary|Change in Engagement in Primary/Specialty Care|The frequency of primary/specialty care visits over two 12-month time periods.|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||Frequency of visits in 12-month periods||Standard Deviation|Mean
1319283|NCT02318797|Primary|Change in Health Status ( SF-12v2™): Physical Health Sub-scale|Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The physical health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains. Scores range from 0-100 and better physical health is indicated by a higher score.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||units on a scale||Standard Deviation|Mean
1319284|NCT02318797|Primary|Change in Patient Activation in Care (PAM, a 13-item Scale)|Assessed using the PAM, a 13-item scale that renders a total activation score. This measure gauges the knowledge, skills, and confidence of patients essential to managing their own health and health care. It divides into progressively higher levels of activation: starting to take a role, building knowledge and confidences, taking action, and maintaining behaviors. The raw score scale for the PAM ranges from 13 to 52. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||units on a scale||Standard Deviation|Mean
1319285|NCT02318693|Secondary|Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)|Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose <70, <60, <50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||Percent change||95% Confidence Interval|Least Squares Mean
1319286|NCT02318693|Secondary|Change From Baseline in 24-hour Mean Glucose Level|The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1319319|NCT02317809|Secondary|Pain Visual Analogue Scale (VAS) Score|The severity of pain was evaluated by the subject and recorded using a 100 millimeter (mm) visual analogue scale (VAS) ranging from 0 to 100, where 0 mm = no pain and 100 mm = worst possible pain.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified time point in each arm, respectively.|||mm||Standard Deviation|Mean
1319525|NCT02313155|Secondary|Change From Baseline in Body Temperature|Change from baseline in body temperature (oral) was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.|||degree celsius||Standard Deviation|Mean
1319287|NCT02318693|Secondary|Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal|The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1319288|NCT02318693|Secondary|Change From Baseline in the Standard Deviation of Blood Glucose Levels|SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1319289|NCT02318693|Primary|Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13|MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1319290|NCT02318667|Secondary|Correlation of Endoscopic Mayo Subscore With Ulcerative Colitis Endoscopic Index Of Severity (UCEIS©) Overall Score at Week 6 and Week 16|UCEIS© is a 3-item (vascular pattern, bleeding and erosion/ulceration) validated tool for assessing endoscopic severity of UC. Each item has 3 or 4 levels of severity and is given a score. The scores for each individual item are combined into a total score ranging from 1 to 11. A higher score indicates increased endoscopic severity of UC. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 6 and Week 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and UCEIS overall score at Week 6 and Week 16.|||rs coefficient||95% Confidence Interval|Number
1319291|NCT02318667|Secondary|Change From Baseline to Week 6 in ST2 Level According to Participant's Mayo Endoscopic Response at Week 16 (Maintained Response at Week 16 or Did Not Maintain Response at Week 16)|ST2, a serum biomarker, was collected prior to study drug administration. Comparison of participants who achieved endoscopic response [endoscopic Mayo subscore 0 or 1] at Week 6 and maintained response through Week 16 versus participants who did not maintain response throughout Week 16, regarding serum soluble ST2 at baseline, Week 6 and change between baseline and Week 6.|Baseline, Week 6|Analysis population includes all participants who had received study medication and achieved endoscopic response at Week 6.|||ng/mL||Standard Deviation|Mean
1319292|NCT02318667|Secondary|Change From Baseline to Week 6 in ST2 Levels in Participants With Active Versus Inactive UC|ST2, a serum biomarker, was collected prior to study drug administration. Active Ulcerative Colitis was defined as an endoscopic Mayo subscore ≥2 and inactive Ulcerative Colitis was defined as an endoscopic Mayo subscore of 0 or 1.|Baseline, Week 6|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity at Week 6.|||ng/mL||Standard Deviation|Mean
1319293|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Clinical Activity (Assessed by Total Mayo Score) at Week 6 and Week 16|ST2, a serum biomarker, was collected prior to study drug administration. The total Mayo Score, is a scale for assessing UC activity and is the sum of 4 subscores (assessment of stool frequency [0-3], rectal bleeding [0-3], Physician’s Global Assessment [0-3], and endoscopic Mayo subscore [0-3]) and has values that range from 0 to 12. Clinical remission: ≤2 points with no individual subscore > 1; Mildly active disease: 3-5 points; Moderately active disease: 6-10 points; Severely active disease: 11-12 points. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Weeks 6 and 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and total Mayo score at Weeks 6 and 16.|||rs coefficient||95% Confidence Interval|Number
1319294|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Faecal Calprotectin Levels at Baseline and Week 6 and Week 16|ST2 and faecal calprotectin, serum biomarkers, were collected prior to study drug administration. Faecal calprotectin is a surrogate marker for the presence of intestinal inflammation and response to treatment in participants with Inflammatory Bowel Disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Baseline, Weeks 6 and 16|Analysis population includes all participants who had received study medication and had a valid faecal calprotectin assessment at time point (Baseline, Week 6, and Week 16).|||rs coefficient||95% Confidence Interval|Number
1319344|NCT02317692|Primary|Engagement in Treatment - Homework Completion (% of Completed Homework)|(recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session)|8 weeks||||percentage of completed homework|Families|Standard Deviation|Mean
1319295|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 16|ST2, a serum biomarker, was collected prior to study drug administration. Geboes index, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 16 Geboes index score.|||rs coefficient||95% Confidence Interval|Number
1319296|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Endoscopic Activity (Assessed by Endoscopy Subscore of Mayo Score) at Week 16|ST2, a serum biomarker, was collected prior to study drug administration. Endoscopic Mayo subscore is one of 4 components that comprise the total Mayo Score, a scale for assessing ulcerative colitis (UC) activity. Endoscopic Mayo subscore ranges from 0-3: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 16 endoscopic Mayo subscore.|||rs coefficient||95% Confidence Interval|Number
1319297|NCT02318667|Primary|Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 6|ST2, a serum biomarker, was collected prior to study drug administration. Geboes index, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 6|Analysis population includes all participants who had received study medication, had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 6 Geboes index score.|||rs coefficient||95% Confidence Interval|Number
1319298|NCT02318667|Primary|Correlation of Serum Soluble Human Suppression of Tumorigenicity 2 (ST2) Levels With Endoscopic Activity of Disease (Assessed by Endoscopy Subscore of Mayo Score) at Week 6|ST2, a serum biomarker, was collected prior to study drug administration. Endoscopic Mayo subscore is one of 4 components that comprise the total Mayo Score, a scale for assessing ulcerative colitis (UC) activity. Endoscopic Mayo subscore ranges from 0-3: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). A higher score indicates more severe disease. Moderate correlation was defined as a Spearman correlation (rs) coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 6|Analysis population includes all participants who had received study medication, had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 6 endoscopic Mayo subscore.|||Spearman correlation (rs) coefficient||95% Confidence Interval|Number
1319299|NCT02318602|Other Pre-specified|Change From Baseline in Frequency of Seizures as a Measure of Seizure Control||through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
1319300|NCT02318602|Other Pre-specified|Clinical Global Impression of Improvement (CGI-I)|"The participant's overall clinical condition is compared to the one week period just before the start of medication (the baseline visit). The participant's condition is compared to the patient's condition at admission to the project [prior to starting treatment] on a 7-point scale, where 1=very much improved since the initiation of treatment; and 7=very much worse since the initiation of treatment.~The CGI-I will be completed for all participants, regardless of chronological and developmental age."|through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
1319301|NCT02318602|Other Pre-specified|Impact of Pediatric Epilepsy Scale (IPES)|"The IPES assesses the impact on academic achievement, participation in activities, health, relationships with family and with peers and siblings, social activities, self-esteem, and the caregiver’s hopes for their child’s future. It takes about 3 minutes for the parent to complete. Each of the 11 items is given a severity score of 0 (not at all) to 3 (a lot). The higher the score, the higher is the impact of epilepsy on that item. The highest total score possible is 33 (range 0–33).~The Impact of Pediatric Epilepsy Scale (IPES) is validated for subjects who are 2 to 16 years of age. Due to developmental delay characteristic of the study population, subjects through 18 years of chronological age will complete the IPES. Subjects over 18 years of chronological age will not complete the IPES."|through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
1319302|NCT02318602|Other Pre-specified|Clinical Global Impression of Severity (CGI-S)|"The severity of the participant's illness is rated on a seven-point scale, where 1=normal, not at all ill, and 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The score reflects the average severity level across the seven days.~The CGI-S will be completed for all participants, regardless of chronological and developmental age."|through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
1319303|NCT02318602|Secondary|Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)|For subjects 7 years of developmental age or older, the Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered to access suicidality. The appropriate adult version will be used in subjects 12 years of (developmental) age and older. The investigator will determine the participant's developmental age.|Up to Week 50||||Participants|||Count of Participants
1319345|NCT02317692|Primary|Engagement in Treatment - Sessions Attended|Number of sessions attended by each family (recorded by clinician)|8 weeks||||sessions|Families|Standard Deviation|Mean
1329622|NCT02107014|Primary|Change in IL-1β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1319304|NCT02318602|Secondary|Vineland Adaptive Behavior Scales (VABS)|"The Vineland Adaptive Behavior Scales measures the personal and social skills of individuals from birth through adulthood. Because adaptive behavior refers to an individual's typical performance of the day-to-day activities required for personal and social sufficiency, these scales assess what a person actually does, rather than what he or she is able to do.~The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. The 4 domains are Communication, Daily Living Skills, Motor Skills, and Maladaptive Behaviour Index. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. A rise in standard scores from Baseline indicates improvement.~The VABS will be completed for all participants."|Up to Week 48|The Safety Analysis Population (SAF) consisted of all participants in the enrolled population group (ENR) who received at least one dose of the investigational product.|||Score on a scale||Standard Deviation|Mean
1319305|NCT02318602|Primary|Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite||Up to Week 50|Insufficient data was collected to perform study analysis.||||||
1319306|NCT02318602|Primary|Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs||Up to Week 50||||Percentage of participants|||Number
1319307|NCT02318602|Primary|Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings||Up to Week 48||||Percentage of participants|||Number
1319308|NCT02318602|Primary|Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values|Laboratory values include chemistry and hematology, and urinary analysis.|Up to Week 50||||Percentage of participants|||Number
1319309|NCT02318602|Primary|Percentage of Participants With Serious Adverse Events|A serious adverse event is any untoward medical occurrence ( whether considered to be related to investigational product or not) that at any dose results in death, is life threatening, requires inpatient hospitalization, results in disability/incapacity, is a congenital abnormality/ birth defect, or medically significant as determined by an investigator.|Up to Week 50||||Percentage of participants|||Number
1319310|NCT02318602|Primary|Percentage of Participants With Adverse Events|An Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment.|Up to Week 50||||Percentage of participants|||Number
1319311|NCT02318303|Primary|Change in rTNSS From Baseline to End of Treatment|"Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.~The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).)~The severity scale for each symptom evaluation was defined as follows:~0 = absent (no sign/symptom evident)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])"|14 days|The full analysis set (FAS) included all randomized subjects who received at least one dose of randomized study medication and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.|||units on a scale||Standard Deviation|Mean
1319312|NCT02317809|Secondary|Neutralizing Antibodies (NAbs) Titers for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose, Day 8 post-dose, follow-up visit (Day 49)|Data could not be collected because as per spondor decision, there were no subjects evaluated for NAb due to low titers (noise) for the ADA .||||||
1319313|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) Titers for Follicle-stimulating Hormone (FSH) at Follow-up Visit||At follow-up visit (Day 49)|"Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here, Number of subjects analyzed included those who have positive ADAs values."|||Log Titers|||Number
1319314|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) Titers for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose and Day 8 post-dose for IMP intervention periods.|"Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here, Number of subjects analyzed included those who have positive ADAs values."|||Log Titers|||Number
1319315|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Follicle-stimulating Hormone (FSH) at Follow-up Visit||At follow-up visit (Day 49)|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
1319316|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose and Day 8 post-dose for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Subjects|||Number
1319317|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Titers for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Data could not be collected as there were no subjects with positive results for ADAs and NAbs.||||||
1319318|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
1319346|NCT02317692|Primary|Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)|Number of families who completed treatment (recorded by clinician)|8 weeks||||Families|Families||Count of Units
1323312|NCT02226198|Secondary|Non-HDL C (mmol/L)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
1319320|NCT02317809|Secondary|Number of Subjects With Local Tolerability/Injection Site Reactions (ISRs)|Injection site was assessed by the study site staff for any local reaction (redness, swelling, bruising, and itching). Redness and bruising were scaled as None (no visible redness or bruising); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising); Severe (>5.0 cm redness or bruising). Swelling was scaled as None (no swelling detected); Mild (palpable ‘firmness’ only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Itching was scaled as None (no itching); Mild itching; Moderate itching and Severe itching. Only those scale categories which report at least 1 subject were presented.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified injection site reaction at the specified time point for each arm, respectively.|||Subjects|||Number
1319321|NCT02317809|Secondary|Serum Estradiol Levels|Data was planned to be presented as per the sequence of treatment received.|Screening (up to 28 days), Day 1 (pre-dose) and Day 8 in Period 1, Day 1 (pre-dose), Day 8 and follow-up (Day 18) in Period 2|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||nanogram per liter (ng/L)||Standard Deviation|Mean
1319322|NCT02317809|Secondary|Number of Subjects With Follicle Size Greater Than (>)13 Millimeter|Transvaginal ultrasound (TVUS) was performed to determine the follicle size and number.|Day 1 (pre-dose) up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
1319323|NCT02317809|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Laboratory Assessments, Vital Signs or Electrocardiogram Findings||Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
1319324|NCT02317809|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a subject, regardless of causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs and non-serious AEs.|Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
1319325|NCT02317809|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration. Apparent volume of distribution (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
1319326|NCT02317809|Secondary|Apparent Serum Clearance (CL/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained is influenced by the fraction of the dose absorbed and was expressed as volume (Liter) per unit of time (hour).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1319327|NCT02317809|Secondary|Apparent Terminal Half-life (t1/2) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Terminal half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
1319328|NCT02317809|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||Hour (h)||Full Range|Median
1319329|NCT02317809|Secondary|Apparent Terminal Elimination Rate Constant (Lambda[z]) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|The elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Per Hour (1/hour)||Geometric Coefficient of Variation|Geometric Mean
1319330|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time Tlast Extrapolated to Infinity (%AUCextra,Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Area under the serum concentration-time curve from Tlast extrapolated to infinity given as a percentage of AUC0-inf. Data was not planned to be summarized if AUCextra,adj was less than 20%.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|As per statistical analysis plan, data was not planned to be summarized because AUCextra,adj was below 20% for all the participants.||||||
1319331|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC0-inf, Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
1319332|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Luteinizing Hormone (LH)|Baseline-corrected Cmax (Cmax,adj) = Cmax – baseline concentration.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
1319333|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Follicle-Stimulating Hormone (FSH)|Baseline-corrected Cmax (Cmax,adj) = Cmax – baseline concentration|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
1319334|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-t,Adj) for Luteinizing Hormone (LH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t – (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
1319335|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC 0-t,Adj) for Follicle-Stimulating Hormone (FSH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t – (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: All randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully down regulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
1319336|NCT02317744|Secondary|Body Mass Index (BMI)|BMI is calculated using measured height and weight.|6 month follow-up (an average of 6 months following treatment)||||kg/m^2||Full Range|Mean
1319337|NCT02317744|Secondary|Body Mass Index (BMI)|BMI is calculated using measured height and weight.|Post-treatment (at 3 months)||||kg/m^2||Full Range|Mean
1319338|NCT02317744|Primary|Binge Eating Frequency (Continuous)|Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).|6 month follow-up (an average of 6 months following treatment)||||binge eating days (out of 28)||Full Range|Mean
1319339|NCT02317744|Primary|Binge Eating Frequency (Continuous)|Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).|Post-treatment (at 3 months)||||binge eating days (out of 28)||Full Range|Mean
1319340|NCT02317692|Secondary|Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)|Socioeconomic status computed based on parental report of education and occupation (assessed on demographic form). Acculturation based on parental report on the Acculturation Rating Scale for Mexican Americans-II and the Mexican American Cultural Values for Adolescents and Adults.|8 weeks|We did not examine this outcome measure due to a lack of variability on the SES and acculturation measure.||||||
1319341|NCT02317692|Secondary|Change in Parental Functioning (Maternal Parenting Stress)|Pre-treatment to post-treatment change on summary score of Parenting Stress Index-Short Form (completed by mothers) Range=0-144; the larger the number, the greater stress Difference in mean pre and post scores for each group, so SD was not calculated.|8 weeks|Only mothers completed.|||units on a scale|Families||Number
1319342|NCT02317692|Secondary|Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)|Pre-treatment to post-treatment change on inattention subscale of Disruptive Behavior Disorders Rating Scale (completed by parent) Range=0-3; the larger the number, the greater the symptoms Difference in mean pre and post scores for each group, so SD was not calculated.|Baseline to 8 weeks||||units on a scale|Families||Number
1319343|NCT02317692|Primary|Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)|Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome)|8 weeks||||units on a scale|Families|Standard Deviation|Mean
1319347|NCT02317549|Primary|Number of Days Alive Without Cardiovascular, Renal or Pulmonary Organ Support|"The patient will be classified as having organ support if organ support is required through the use of:~Mechanical ventilation;~Vasopressors to maintain adequate blood pressure (BP), or~Renal replacement therapy."|Through day 28.|5 subjects were treated with LB1148, and 3 subjects were treated with placebo. Upon review of patient charts after the study was terminated, 1 patient on placebo was enrolled on the basis of a Glasgow Coma Score calculated while under sedation, which allowed SOFA score to meet study criteria and the patient to be inappropriately enrolled.|||days||Full Range|Mean
1319348|NCT02317510|Secondary|Headache|Group 1 and Group 2 Headache|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old.|||participants|||Number
1319349|NCT02317510|Secondary|Nausea/Vomiting|Group 1 and group 2 nausea/vomiting|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old.|||participants|||Number
1319350|NCT02317510|Secondary|Urinary Retention|Group 1 and Group 2 Urinary retention|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old|||participants|||Number
1319351|NCT02317510|Secondary|Intra-operative Shoulder Pain|Group 1 and Group 2 Intra-operative shoulder pain|during operation time, up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.|||participants|||Number
1319352|NCT02317510|Primary|Post-operative Shoulder Pain|Group 1 and Group 2 Post-operative shoulder pain|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old|||participants|||Number
1319353|NCT02317510|Secondary|Post-operative Abdominal Pain 24th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 24th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
1319354|NCT02317510|Secondary|Post-operative Abdominal Pain 12th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 12th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
1319355|NCT02317510|Secondary|Post-operative Abdominal Pain 6th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 6th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
1319356|NCT02317510|Secondary|Post-operative Abdominal Pain 4th Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 4th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
1319357|NCT02317510|Secondary|Post-operative Abdominal Pain 2nd Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 2nd hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
1319358|NCT02317510|Secondary|Duration of Anaesthesia|Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.|||minutes||Standard Deviation|Mean
1319359|NCT02317510|Primary|Duration of Operation|group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.|||minutes||Standard Deviation|Mean
1319360|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of AUCtau (MRAUCtau) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRAUCtau for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1319361|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of Css,Max (MRCss,Max) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRCss,max for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1329623|NCT02107014|Primary|Change in IL-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1319362|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance at Steady State (CLss/F) for AZD9291 Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291 by assessment of CLss/F after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1319363|NCT02317016|Secondary|Assessment of Minimum Plasma Concentration at Steady State (Css,Min) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,min over the dosing interval. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
1319364|NCT02317016|Secondary|Assessment of Time to Reach Maximum Plasma Concentration at Steady State (Tss,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of tss,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
1319365|NCT02317016|Secondary|Assessment of Maximum Plasma Concentration at Steady State (Css,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
1319366|NCT02317016|Secondary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUCtau) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of AUCtau. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanomolar * h (nM*h)||Geometric Coefficient of Variation|Geometric Mean
1319367|NCT02317016|Secondary|Assessment of Terminal Elimination Half-life (t1/2[lambda_z]) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of t1/2(lambda_z). Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Geometric Coefficient of Variation|Geometric Mean
1319368|NCT02317016|Secondary|Assessment of Apparent Volume of Distribution (Vz/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Vz/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||L||Geometric Coefficient of Variation|Geometric Mean
1319369|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance (CL/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of CL/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Litre / h (L/h)||Geometric Coefficient of Variation|Geometric Mean
1319370|NCT02317016|Secondary|Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration at Time “t” (AUC0-t) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of AUC0-t. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1323313|NCT02226198|Secondary|Non-HDL C (mg/dL)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
1319371|NCT02317016|Secondary|Assessment of Time to Maximum Plasma Concentration (Tmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of tmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
1319372|NCT02317016|Primary|Assessment of AUC From Time Zero Extrapolated to Infinity for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of AUC from time zero extrapolated to infinity. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng * h o u r per mL (ng*h/mL )||Geometric Coefficient of Variation|Geometric Mean
1319373|NCT02317016|Primary|Assessment of Maximum Plasma Concentration (Cmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Cmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1 [Period 1] and Day 32 [Period 3], respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1319374|NCT02316847|Primary|Change in Taste as Measured by a Taste Change Questionnaire|Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10).|Weeks 12, 24|Safety Population - Number of subjects with at least one change in taste after dose administration. 6 Adults at 12 Weeks and 4 Adults at 24 weeks. No Adolescents participated.|||units on a scale||Standard Deviation|Mean
1319375|NCT02316847|Primary|Change From Baseline (Screening) in Nasal Mucosa.|"Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation none to Grade 4 septal perforation."|Screening, Weeks 12, 24, 36, 48 and 51|Safety Population|||Participants|||Count of Participants
1319376|NCT02316847|Primary|Olfactory Changes as Measured by the Smell Identification Test (SIT)|The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5.|Screening, weeks 12, 24, 36, 48 and 51|Of 91 subjects in the Safety Population, data was available for 62 subjects at screening.|||Participants|||Count of Participants
1319377|NCT02316769|Secondary|Time to Intubation|Number of patients intubated in less than 90 seconds|Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.||||participants|||Number
1319378|NCT02316769|Primary|Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide||participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.||||participants|||Number
1319379|NCT02316678|Primary|Mortality Rate|"Incidence of death per 1000 person-years~Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD."|See Outcome Measure Description above|Patients treated with corticosteroids (CS) within the prior year and subsequently received either additional CS therapy meeting the definition of prolonged CS use or newly initiated anti-TNF therapy were included in the study.|||events per 1000 person-years|||Number
1319380|NCT02316613|Secondary|Number and Type of Hospitalization Associated With MabThera Perfusion|Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.|Up to 6 years|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||hospitalizations|Participants||Number
1319381|NCT02316613|Secondary|Function Assessment of Chronic Illness Therapy–General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score|"The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0–28; social well-being, scored 0–28; functional well-being, scored 0–28; emotional well-being, scored 0–24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, Not at all to 4, Very much). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items."|Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. n=number of evaluable questionnaires for each category.|||score on scale|Participants|Standard Deviation|Mean
1319382|NCT02316613|Secondary|Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase||Maintenance phase : 67.8 months|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one MabThera infusion over the maintenance therapy period. n=number of evaluable participants for each category.|||percentage of participants|||Number
1319383|NCT02316613|Secondary|MabThera Regimen: Time Between Cycles||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.|||days||Standard Deviation|Mean
1319384|NCT02316613|Secondary|MabThera Regimen: Number of Cycles of MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.|||number of cycles||Standard Deviation|Mean
1319385|NCT02316613|Secondary|MabThera Regimen: Infusion Duration||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.|||minutes (mn)||Standard Deviation|Mean
1319386|NCT02316613|Secondary|MabThera Regimen: Dose of MabThera|All participants who received MabThera treatment before the first disease progression were reported.|Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.|||milligram (mg)||Standard Deviation|Mean
1319387|NCT02316613|Primary|Number of Participants With Therapeutic Management After the First Study Disease Progression|After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.|||participants|||Number
1319388|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression|The therapeutic management of participants was decided by either “pluri-disciplinary consultation meeting,” “Only the physician in charge of the participant,” “Discussion between physicians,” or “Punctual consultation of an external physician.” Percentage of participants with each of these modalities of therapeutic decision was reported.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.|||percentage of participants|||Number
1319389|NCT02316613|Primary|Percentage of Participants With Injection Prophylaxis Treatment|Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number participants analyzed= all participants having had maintenance/observation period before the first study disease progression and received infection prophylaxis treatment.|||percentage of participants|||Number
1319390|NCT02316613|Primary|Percentage of Participants With Prescription of Injection Prophylaxis|Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed=all participants having had maintenance/observation period before the first study disease progression.|||percentage of participants|||Number
1319391|NCT02316613|Primary|Duration of MabThera Maintenance Therapy When Associated With Observation|Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one infusion of MabThera and completed maintenance therapy with MabThera when associated with observation period.|||months||Full Range|Median
1319392|NCT02316613|Primary|Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase|After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one MabThera infusion over the maintenance therapy period.|||percentage of participants|||Number
1319411|NCT02316470|Secondary|Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)|percentage of study participants with at least one unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
1319393|NCT02316613|Primary|Percentage of Participants With MabThera as Maintenance Therapy|During the maintenance period participants received four weekly infusion of MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those who entered in maintenance/observation after the first induction and before the first disease progression over the study.|||percentage of participants||95% Confidence Interval|Number
1319394|NCT02316613|Primary|Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase|Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||percentage of participants|||Number
1319395|NCT02316613|Primary|Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase|Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin’s lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||percentage of participants|||Number
1319396|NCT02316613|Secondary|Number of Participants Who Used MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||participants|||Number
1319397|NCT02316613|Secondary|Overall Survival (OS)|The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||months||95% Confidence Interval|Median
1319398|NCT02316613|Secondary|Time to Next Treatment|Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||months||95% Confidence Interval|Median
1319399|NCT02316613|Secondary|Progression Free Survival (PFS)|The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||months||95% Confidence Interval|Median
1319400|NCT02316613|Secondary|Percentage of Participants With Disease Characteristics at First Study Disease Progression|Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. n=number of evaluable participant for each disease characteristics.|||percentage of participants|||Number
1319401|NCT02316613|Secondary|Percentage of Participants With Number of Disease Progressions|Participants with at least one disease progression after the first study induction period were reported.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those participants who entered in maintenance/observation after the first induction and before the first disease progression over the study.|||percentage of participants|||Number
1319412|NCT02316470|Secondary|Rate of Study Participants With at Least One Related SAE|percentage of study participants with at least one related SAE starting up to Day 56 and up to Day 210|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
1319413|NCT02316470|Secondary|Rate of Study Participants With at Least One SAE (Serious Adverse Event)|percentage of study participants with at least one SAE starting up to Day 56 and up to Day 210|Day 56 and Day 210|Safety Population = study participants who received at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
1319427|NCT02316470|Secondary|SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 14, 28, 35, 120 and 210;|Days 14, 28, 35, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319402|NCT02316613|Secondary|Percentage of Participants With Last Induction Treatment Response|Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter’s syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed (N)=number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1319403|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase|At study inclusion, the therapeutic management of participants was decided by either “pluri-disciplinary consultation meeting,” “Only the physician in charge of the participant,” “Discussion between physicians,” or “Punctual consultation of an external physician.” Percentage of participants with each of these modalities of therapeutic decision was reported.|Baseline|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1319404|NCT02316548|Secondary|Number of Patients With Bowel Toxicity|Adverse events (AE) evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Bowel toxicity= abdominal distension/pain, colitis, colonic fistula/ hemorrhage/obstruction/perforation/stenosis/ulcer, diarrhea, enterocolitis, fecal incontinence/gastrointestinal/fistula/pain, ileal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, Ileus, jejunal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, lower gastrointestinal hemorrhage, rectal fistula/hemorrhage/mucositis/necrosis/obstruction/pain/perforation/stenosis/ulcer, small intestinal mucositis/obstruction/perforation/stenosis/ulcer, vomiting. Highest grade adverse event per subject counted. Grade refers to AE severity and ranges from 1 to 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1 Mild, 2 Moderate, 3 Severe, 4 Life-threatening or disabling, 5 Death related to AE.|From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months|Randomized eligible patients with adverse event data|||Participants|||Count of Participants
1319405|NCT02316548|Secondary|Disease Free Survival (DFS)|Disease free survival (DFS) is defined as the first occurrence of either: pelvic failure, distant metastasis, or death and was to be estimated by the Kaplan-Meier method and arms compared using the log-rank test. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. Distant metastases is defined as any hematogenous metastases and/or lymph node metastases above the L5-S1 interspace, documented by imaging (CT and/or MRI and/or bone scans). Due to early termination with few patients, only counts of events have been calculated.|From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months|Randomized eligible patients with disease assessment data|||Participants|||Count of Participants
1319406|NCT02316548|Primary|Pelvic Recurrence-free Survival (PRFS)|PRFS is defined as time free of pelvic recurrence or death, with patients who experience distant metastasis censored at the time of occurrence. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. PRFS was to be tested between arms in terms of a difference in cause-specific-hazards using the log-rank test and cumulative incidence of PRFS in the presence of competing risks was to be computed via cumulative incidence. Due to early termination with few patients, only counts of events have been calculated.|From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months|Randomized eligible patients with disease assessment data|||Participants|||Count of Participants
1319407|NCT02316470|Secondary|Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group|percentage of participants with solicited (sol.) local and systemic AEs within 7 days after each and after any vaccination (vacc.), collected via a subject diary with predefined terms, stratified by age group (subjects 50 - < 65 years and 65 years and older)|within 7 Days after each vaccination|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
1319408|NCT02316470|Secondary|Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group|percentage of study participants with at least one SAE, related SAE, unsolicited (unsol.) AE (incl. clinically significant laboratory parameter changes) and related unsolicited AE, starting up to Day 56 and Day 210, stratified by age group (subjects 50 - < 65 years and 65 years and older (65+))|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
1319409|NCT02316470|Secondary|Rates of Study Participants With at Least One Solicited Local and Systemic AE|percentage of study participants with solicited local and systemic AE within 7 days after each and after any vaccination, collected via a subject diary with predefined terms|within 7 Days after each vaccination|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
1319410|NCT02316470|Secondary|Rate of Study Participants With at Least One Related Unsolicited AE|percentage of study participants with at least one related unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
1319414|NCT02316470|Secondary|Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group|"Responder Rate for neutralizing antibodies against Toxin A (RR Tox A), against Toxin B (RR Tox B) and against both Toxin A and Toxin B (RR Tox A and B) on Days 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319415|NCT02316470|Secondary|Responder Rate (RR) for Toxin B Neutralizing Antibodies|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin B on Days 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319416|NCT02316470|Secondary|Responder Rate (RR) for Toxin A Neutralizing Antibodies|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin A on Days 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319417|NCT02316470|Secondary|Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120, 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319418|NCT02316470|Secondary|GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group|"GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||Titer||95% Confidence Interval|Geometric Mean
1319419|NCT02316470|Secondary|GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group|GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)|Days 0, 14, 28, 35, 56, 120, 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||EU/ml||95% Confidence Interval|Geometric Mean
1319420|NCT02316470|Secondary|SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group|Seroconversion Rate (SCR) for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)|Days 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319421|NCT02316470|Secondary|GMT for Toxin B Neutralizing Antibodies|"GMT for Toxin B neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||Titer||95% Confidence Interval|Geometric Mean
1319422|NCT02316470|Secondary|GMT for Toxin A Neutralizing Antibodies|"GMT for Toxin A neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||Titer||95% Confidence Interval|Geometric Mean
1319423|NCT02316470|Secondary|Geometric Mean Titer (GMT) for IgG Against Toxin B|Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;|Days 0, 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||EU/ml||95% Confidence Interval|Geometric Mean
1319424|NCT02316470|Secondary|Geometric Mean Titer (GMT) for IgG Against Toxin A|Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;|Days 0, 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||EU/ml||95% Confidence Interval|Geometric Mean
1319425|NCT02316470|Secondary|Seroconversion Rate (SCR) for IgG Against Toxin B|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin B;|Days 14, 28, 35, 56, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319426|NCT02316470|Secondary|Seroconversion Rate (SCR) for IgG Against Toxin A|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin A;|14, 28, 35, 56, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
1319428|NCT02316470|Primary|Seroconversion Rate (SCR) on Day 56|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;|Day 56|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of study participants||95% Confidence Interval|Number
1319434|NCT02315989|Secondary|Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable|Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).|Average 100 days after treatment.||||percentage of participants|||Number
1319435|NCT02315989|Secondary|Percentage of System Errors|During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly.|Average 100 days after treatment.||||percentage of system errors|||Number
1319436|NCT02315989|Primary|Rate and Severity of Adverse Reactions|After enrollment, each patient has to receive physical examination, laboratory tests, and image studies as baseline. During the course of radiotherapy, patients will have weekly evaluations in physicals and laboratory tests. Image studies are optional during treatment. In the follow-up periods, monthly exams, including regular physicals, markers in serum and urine and image studies to evaluation treatment responses, will be scheduled till 90 days after the end of treatment.|Average 90 days after treatment.||||participants|||Number
1319437|NCT02315560|Secondary|Quality of Life Questionnaire Scores|The NLUTD/DES questionnaire (Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome) has been validated and is reliable for assessing lower urinary tract and bowel dysfunction. The questionnaire is scored using a 5-point Likert scale. The questionnaire consists of a total of 14 questions, each question asking about a symptom. Question #7 specifically addresses nocturnal enuresis. A score of 4 indicates severe symptoms, while a score of 0 indicates none. The maximum score is 52, indicating the most severe symptoms, while the minimum score of zero indicates zero symptoms. Scores of 11 or greater indicate bladder or bowel dysfunction.|6 weeks||||units on a scale||Full Range|Mean
1319438|NCT02315560|Primary|Decrease in Nocturnal Enuresis|To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log. The outcome is the number of participants that had a clinical response with improvement of at least 1 wet night reduction during the 6-week stimulation period.|6 weeks||||Participants|||Count of Participants
1319439|NCT02315352|Secondary|Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication||2-5 minutes|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.|||Subjects|||Number
1319440|NCT02315352|Secondary|Number of Subjects With Mouth Feeling and Taste Description Evaluation|Mouth feeling was described in terms of “sweet”, “bitter”, “sticky” or “smooth” as per the experience of the subject with the trial medication.|2-5 minutes (After the IMP has been spat out)|The data for this outcome measure could not be evaluated as data were not collected according to protocol.||||||
1319441|NCT02315352|Secondary|Overall Palatability VAS Score at 2-5 Minutes|Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.|2-5 minutes (After the IMP has been spat out)|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.|||units on a scale||Standard Deviation|Mean
1319442|NCT02315352|Primary|Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])|Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.|0 minute (Right After the Spit-out of the IMP)|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.|||units on a scale||Standard Deviation|Mean
1319443|NCT02314689|Secondary|Nitric Oxide|Unposted|2 years||2018-12-31|12/2018||||
1319444|NCT02314689|Primary|Number of Participants With Grade 2 or Higher Adverse Event According to NCI Criteria||2 years||||participants|||Number
1319445|NCT02314637|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||mg/dL||Standard Deviation|Mean
1319446|NCT02314637|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||percent||Standard Deviation|Mean
1319447|NCT02314637|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.|||participants|||Number
1319448|NCT02314546|Secondary|Verbal Complaints|Recorded by the administering RN at one minute post-administration|1 minute post-administration||||participants|||Number
1319449|NCT02314546|Secondary|Verbal Complaint|Recorded by the administering RN at the time of administration.|At time of administration||||participants|||Number
1319450|NCT02314546|Secondary|RN Observed Behavioral Distress Score|Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration||||units on a scale||Standard Deviation|Mean
1319498|NCT02313675|Secondary|Opioid Consumption (Number of Pills Taken)|"Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively~Outcome measure reported below is mean number of opioid pills consumed per day."|7 days||||pills consumed||Full Range|Mean
1319451|NCT02314546|Secondary|Parental Observed Behavioral Distress Score|Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration||||units on a scale||Standard Deviation|Mean
1319452|NCT02314546|Primary|Time From Administration to Discharge||Minutes from administration to discharge||||minutes||Standard Deviation|Mean
1319453|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|15 minutes post-sedation|participants with available data at this time point|||participants|||Number
1319454|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|10 minutes post-sedation|participants with available data at this time point|||participants|||Number
1319455|NCT02314520|Secondary|Number of Participants With a Central Line Associated Blood Stream Infection|A Central access associated infection (CLABSI)|up to 10 weeks||||Participants|||Count of Participants
1319456|NCT02314520|Secondary|Number of Patients With Complications Related to Insertion|Any complication of insertion including technical failure|From the time of insertion until first confirmatory chest X-ray||||Participants|||Count of Participants
1319457|NCT02314520|Secondary|Number of Participants With Deep Venous Thrombosis||up to 10 weeks||||Participants|||Count of Participants
1319458|NCT02314520|Primary|Participants With Complications With Central Access Including Insertion|Aggregation of all complications associated with central access including insertion|up to 10 weeks||||Participants|||Count of Participants
1319459|NCT02314260|Secondary|Cut Off Value for Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% & specificity was 73% to failed induction|||probability|||Number
1319460|NCT02314260|Secondary|Cut Off Value for The Modified Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% and a specificity of 87% for failed induction.|||probability|||Number
1319461|NCT02314260|Secondary|Area Under Curve for The Bishop Score|to predict failed induction and comparing it to the area under curve for modified bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section. The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity), So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction of labour fails, the Y-axis of the curve is (sensitivity) and the x- axis is (1-specificity).|||probability||95% Confidence Interval|Number
1319462|NCT02314260|Primary|Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score|to predict failed induction and comparing it to the area under curve for bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section.The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity). So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|the area under the modified bishop score was 0.916 (95% [confidence interval ] 0.85–0.97). The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|||probability||95% Confidence Interval|Number
1319463|NCT02314247|Secondary|Progression Free Survival (PFS)|Duration of time from start of study treatment to date of disease progression or death from any cause.|Study treatment start date to date of disease progression or date of death. Patients without documented PD are censored on date of last radiologic assessment.|Intent to Treat population.|||Days||95% Confidence Interval|Median
1319464|NCT02314247|Secondary|Disease Control Rate (DCR)|Percentage of patients who have CR, PR, or SD lasting ≥ 8 weeks. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat (ITT) Population|||Percentage of participants||80% Confidence Interval|Number
1319465|NCT02314247|Secondary|Duration of Stable Disease, Including Patients With Partial Response|Duration of time from the date of start of study treatment to the date of disease progression. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment.|Those participants with stable disease, including those with partial response, as a subset of the Intent to Treat (ITT) population|||Days||95% Confidence Interval|Median
1319466|NCT02314247|Primary|Best Overall Response: Not Evaluable (NE)|Patients who could not be assessed quantitatively for disease response for any reason.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
1319499|NCT02313675|Primary|Postoperative Pain (Pain Scores From 0-10 Scale)|This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.|7 days||||units on a scale||95% Confidence Interval|Mean
1319954|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|Baseline||||participants|||Number
1319467|NCT02314247|Primary|Best Overall Response: Progressive Disease (PD)|Patients whose best overall response to study treatment was PD. Progression was defined as the first occurrence of progressive disease (PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
1319468|NCT02314247|Primary|Best Overall Response: Stable Disease (SD)|Patients whose best overall response to study treatment was SD (failure to attain criteria needed for CR or PR, or to meet criteria for PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
1319469|NCT02314247|Primary|Best Overall Response: Partial Response (PR)|Patients whose best overall response to study treatment was PR (regression of measurable disease and no new sites). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat (ITT) population|||Participants|||Count of Participants
1319470|NCT02314247|Primary|Best Overall Response: Complete Response (CR)|Patients who achieved CR (disappearance of all detectable evidence of disease). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
1319471|NCT02314247|Primary|Overall Response Rate (ORR)|Overall Response (OR) = Complete Response (CR) + Partial Response (PR). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Progression was defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Due to the limited enrollment in this study, only the Intent to Treat (ITT) Population, consisting of all patients who received at least 1 dose of study treatment (which is identical to the Safety Population), was evaluated for efficacy.|||Percentage of participants||80% Confidence Interval|Number
1319472|NCT02314169|Other Pre-specified|Expression of Biomarkers Using Immunohistochemistry and Blood Samples|Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. For continuous outcomes, t-test and analysis of variance will be used to compare outcome measures across patient characteristics. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square test or Fisher’s exact test will be used to test the association between two categorical variables. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.|Up to time of treatment discontinuation|||||||
1319473|NCT02314169|Secondary|Progression-free Survival|From initiation of treatment with nivolumab until the time of disease progression, time measured in months. Kaplan-Meier analysis performed to estimate the median progression-free survival with a 90% confidence interval.|From initiation of treatment with nivolumab until the time of disease progression, assessed up to 2 years||||months||90% Confidence Interval|Median
1319474|NCT02314169|Secondary|Overall Survival|Time measured from initiation of treatment with nivolumab till death. Kaplan-Meier analysis will be performed to estimate the median overall survival with a 95% confidence interval.|From initiation of treatment with nivolumab until death, assessed up to 2 years||||Months||95% Confidence Interval|Median
1319475|NCT02314169|Secondary|Summary Incidence of Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|The most frequent of adverse events measured relative to the total number of patients treated, and the toxicities tabulated by grade according to CTCAE.|Up to 100 days post-treatment||||participants|||Number
1319526|NCT02313155|Secondary|Change From Baseline in Pulse|Change from baseline in pulse was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.|||beats per minute||Standard Deviation|Mean
1319757|NCT02307318|Primary|Incidence of Thrombosis|Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.|4 hours post-surgery||||Participants|||Count of Participants
1319476|NCT02314169|Primary|Overall Response Rate: Number of Participants With Response|Responses assessed using computed tomography (CT) scans or magnetic resonance imaging according to standard Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria in order to assess disease progression. Complete Response (CR): Disappearance all target lesions; any pathological lymph nodes reduction in short axis to <10 mm (<1 cm). Partial Response (PR): > 30% decrease in sum diameters of target lesions. Progressive Disease (PD): > 20% increase in sum diameters lesions. (Note: appearance of one or > new lesions considered progressions). Stable Disease (SD): Neither shrinkage qualify for PR nor increase for PD.|Up to 2 years|Four participants were not evaluable for response and excluded from analysis.|||Participants|||Count of Participants
1319477|NCT02314117|Secondary|PK: Minimum Concentration (Cmin) of Ramucirumab|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab|Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI|All randomized participants who received ramucirumab and had evaluable PK data|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1319478|NCT02314117|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab|Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab|Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI|All randomized participants who received ramucirumab and had evaluable PK data.|||Microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1319479|NCT02314117|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.|Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1319480|NCT02314117|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|The time from the date of randomization to the first date observing ECOG PS ≥2 (that is, deterioration from baseline status of 0 or 1). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. ECOG Performance Status: 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled. Cannot carry on any selfcare.Totally confined to bed or chair,5- Dead.|Randomization to ECOG PS ≥2 (Up To 26 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=254 and Placebo + Cisplatin + Capecitabine= 260.|||months||95% Confidence Interval|Median
1319481|NCT02314117|Secondary|Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)|The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.|Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)|All randomized participants who provided data at baseline and cycle 6.|||units on a scale||Standard Deviation|Mean
1319482|NCT02314117|Secondary|Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale|Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment.|Randomization, First worsening in QoL (Up To 26 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=215 and Placebo + Cisplatin + Capecitabine=217|||months||95% Confidence Interval|Median
1319483|NCT02314117|Secondary|Duration of Response (DoR)|Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to <10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment.|Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)|All randomized participants. Participants censored : Ramucirumab + Cisplatin + Capecitabine= 23 and Placebo + Cisplatin + Capecitabine=10.|||months||95% Confidence Interval|Median
1319484|NCT02314117|Secondary|Time to Progression (TTP)|TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).|Randomization to Disease Progression (Up To 24 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=149 and Placebo + Cisplatin + Capecitabine=111.|||months||95% Confidence Interval|Median
1319500|NCT02313558|Primary|Gingivitis Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
1319485|NCT02314117|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions – CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).|Randomization to Disease Progression (Up To 26 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1319486|NCT02314117|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions – CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.|Randomization to Disease Progression (Up To 26 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1319487|NCT02314117|Secondary|Progression- Free Survival 2 (PFS2)|PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST.|Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=74 and Placebo + Cisplatin + Capecitabine=74.|||months||95% Confidence Interval|Median
1319488|NCT02314117|Secondary|Overall Survival (OS)|OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive.|Randomization to Death from Any Cause (Up To 30 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=88.|||months||95% Confidence Interval|Median
1319489|NCT02314117|Primary|Progression-free Survival (PFS)|PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.|Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)|First 508 randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=62.|||months||95% Confidence Interval|Median
1319490|NCT02314104|Secondary|Total Narcotic Usage in Morphine Equivalents||up to twenty-four hours postoperatively||||mg||Standard Deviation|Mean
1319491|NCT02314104|Secondary|Time Until First Request for Pain Medication||up to twenty-four hours postoperatively||||minutes||Inter-Quartile Range|Median
1319492|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|twenty-four hours postoperatively|Arm 1: one subject discharged prior to obtaining 24 hour pain score Arm 2: one subject discharged prior to obtaining 24 hour pain score Arm 3: four subjects discharged prior to obtaining 24 hour pain score|||units on a scale||Standard Deviation|Mean
1319493|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|six hours postoperatively|Arm 2: 6 hour pain score not obtained on one subject Arm 3: 6 hour pain score not obtained on one subject|||units on a scale||Standard Deviation|Mean
1319494|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|one hour postoperatively||||units on a scale||Standard Deviation|Mean
1319495|NCT02313766|Secondary|Discomfort of the Preoxygenation Phase Self Reported by the Patient|discomfort of the preoxygenation phase evaluated on a visual analogue scale (0 no discomfort - 100 maximal discomfort) just before PACU leaving|Before PACU leaving||||millimeters||Inter-Quartile Range|Median
1319496|NCT02313766|Secondary|Time Until SpO2=93%|time until SpO2=93% after endotracheal tube placement has been confirmed|up to 10 min||||seconds||Inter-Quartile Range|Median
1319501|NCT02313558|Primary|Plaque Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
1319502|NCT02313558|Primary|Gingivitis Assessment After 6 Weeks of Dentifrice Use|After 6 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.|6 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
1319503|NCT02313558|Primary|Plaque Assessment After 6 Weeks of Dentifrice Use|"After 6 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|6 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
1319504|NCT02313233|Primary|Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge|The Quality of Life (QoL) is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.|||units on a scale||Standard Deviation|Mean
1319505|NCT02313233|Primary|International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months.|||units on a scale||Standard Deviation|Mean
1319506|NCT02313233|Primary|Quality- Of- Life Index (QoL)|The QoL index is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Hatnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment|||units on a scale||Standard Deviation|Mean
1319507|NCT02313233|Secondary|Prostate-specific Antigen (PSA) Level|Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||ng/ml||Standard Deviation|Mean
1319508|NCT02313233|Secondary|Prostate Volume|It's related to progression of benign prostatic hyperplasia (BPH).|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||cm^3||Standard Deviation|Mean
1319509|NCT02313233|Secondary|Postvoid Residual Volume (PVR)|The PVR urine test measures the amount of urine left in the bladder after urination.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receivingHarnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||ml||Standard Deviation|Mean
1319510|NCT02313233|Secondary|Maximum Flow Rate (Qmax)|It's used to determine the degree of urinary difficulty.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment.|||ml/ sec||Standard Deviation|Mean
1319511|NCT02313233|Primary|International Prostate Symptom Score (IPSS)|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|For all subjects' medical histories in this study, there are one subject receiving Hatnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||units on a scale||Standard Deviation|Mean
1319512|NCT02313155|Secondary|GMT in SRH Antibody Titer (Cell Derived Antigen)|GMT in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
1319955|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|20 minutes||||units on a scale||Standard Deviation|Mean
1319513|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
1319514|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319515|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with a SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319516|NCT02313155|Secondary|GMT in HI Antibody Titer (Cell Derived Antigen)|GMT in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
1319517|NCT02313155|Secondary|GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
1319518|NCT02313155|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline HI <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319519|NCT02313155|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40|Seroprotection rate as measured by HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with an HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319520|NCT02313155|Secondary|GMT in SRH Antibody Titer (Egg-derived Antigen)|GMT in SRH antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
1319521|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (egg-derived antigen) as compared to baseline pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days after vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
1319522|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319523|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) was defined as percentage of participants with an SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319524|NCT02313155|Secondary|Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)|GMT in HI antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
1319956|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|Baseline||||units on a scale||Standard Deviation|Mean
1319527|NCT02313155|Secondary|Change From Baseline in Blood Pressure|Change from baseline in systolic and diastolic blood pressure was reported|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.|||millimeter mercury (mmHg)||Standard Deviation|Mean
1319528|NCT02313155|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|Laboratory values included hematology, biochemistry and urinalysis tests.|Baseline,up to 21 Days after drug administration (Day 22)|Safety analysis set was defined as all participants who received vaccination with the study drug.|||participants|||Number
1319529|NCT02313155|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (egg-derived antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
1319530|NCT02313155|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319531|NCT02313155|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.|Seroprotection rate as measured by HI antibody titer (egg-derived antigen) was defined as percentage of participants with the HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
1319532|NCT02313155|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.|||participants|||Number
1319533|NCT02313155|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.|||participants|||Number
1319534|NCT02312882|Primary|Percent Change in Severity of Alopecia Tool (SALT) Score|SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score.|0 and 3 months||||Percent change||Full Range|Median
1319535|NCT02312739|Secondary|Provider Ease of Insertion (0-100mm VAS)|Physician who did the procedure will complete a 0-100mm VAS on ease of insertion of the sterilization devices with anchors 0 equals no difficulty and 100 equals very difficult.|Within 5 minutes after the Essure® procedure||||units on a scale||Standard Deviation|Mean
1319536|NCT02312739|Secondary|Patient Satisfaction (5-point Likert Scale)|Patients were asked to rate their overall satisfaction with the procedure using a 5-point Likert scale (Very unsatisfied, Unsatisfied, Neutral, Satisfied, Very satisfied). Results were analyzed to portray the percentage of participants who felt satisfied at the listed interval levels.|Prior to discharge from clinic, approximately 30-45 minutes post-procedure||||percentage of participants|||Number
1319537|NCT02312739|Secondary|Change From Baseline in Patient Anxiety Scale After the Procedure|Participants were asked to complete a validated short form of the Spielberger State-Trait Anxiety Inventory (STAI) at baseline and at 3-5 minutes after the in-office sterilization procedure. On the STAI scale, participants rated five statements (I feel calm, I am tense, I feel upset, I am relaxed, I am worried) on a 1 - 4 scale (Not at all, Somewhat, Moderately, Very Much, totaling in a score from 0-20 (0 being least anxious, 20 being the most anxious).|At baseline before the procedure and at 3-5 minutes after the Essure® procedure||||units on a scale||Standard Deviation|Mean
1319538|NCT02312739|Primary|Pain Scale Measurement - Maximum Pain Experienced|The maximum pain that was experienced during the procedure is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at 3 to 5 minutes following completion of the procedure.|At 3-5 minutes after the procedure||||units on a scale||Standard Deviation|Mean
1319539|NCT02312739|Primary|Change From Baseline in Pain Scale Measurement During and After the Procedure|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at baseline, after paracervical block injection and after placement of second Essure® coil. A final pain assessment is done prior to discharge.|At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)||||units on a scale||Standard Deviation|Mean
1319540|NCT02312726|Other Pre-specified|Provider Ease-of-insertion|The provider who inserts the IUD will be asked to complete a 4-item Likert scale rating perceived difficultly of insertion: 1 = easy; 2 = somewhat easy; 3 = somewhat difficult, 4 = difficult.|Within 5 minutes following postpartum IUD insertion||||participants|||Number
1319565|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 8 hours to determine the percentage of hypothermia in both groups.|8 Hours of Infant Life||||Participants|||Count of Participants
1319541|NCT02312726|Secondary|Pain Score: Verbal Rating Scale (VRS)|This is a 4-item ordinal pain scale which has been used for pain level assessment. When prompted, patients will be asked to indicate which level of pain most accurately represents their pain level; 0 = No pain, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery. Women who undergo a postpartum interview will be asked to perform a recal VRS pain assessment||||participants|||Number
1319542|NCT02312726|Secondary|Pain Score: Visual Analog Scale (VAS)|This is a validated instrument used extensively in the assessment of acute pain. When prompted, patients will be asked to mark the continuous 100 mm VAS line at the point which most accurately represents their pain level; 0 = no pain, 100 = pain as bad as it could be.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery; women who undergo a postpartum interview will be asked to perform a recall VAS pain assessment||||units on a scale||Standard Deviation|Mean
1319543|NCT02312726|Primary|Assessment of Women’s Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews|A semi-structured interview guide(available in both English and Spanish) which was developed in consultation with an expert in qualitative methodology at the UNM Clinical & Translational Science Center (CTSC), and UNMH family planning experts, will be administered to all participants. The interview will incorporate the following domains of women’s perceptions of the postplacental IUD insertion experience: decisional influence, experience during the procedure, decisional regret, prior knowledge/ awareness of the method and postpartum contraception in general. The interview will conclude with an overall patient satisfaction score measured on a five-point Likert scale: 1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, 5 = very satisfied.|Within 24-48 hours after vaginal delivery, prior to hospital discharge|21 participants (out of the 68 included in the study) consented to an interview regarding their experience. We conducted 21 interviews; 9 with women who did not have an epidural and 12 with women who had an epidural.|||participants|||Number
1319544|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items|Number of minutes per week, on average, they are completing strengthening, stretching, and aerobic exercises. The minimum score is 0, and there is no maximum score; higher scores indicate more weekly activity.|baseline, 4 months, and 12 months||||minutes per week||95% Confidence Interval|Least Squares Mean
1319545|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)|"The Physical Activity Scale for the Elderly (PASE) is a self-report, 12-item scale that measures level occupational, household, and leisure activity during a one-week period. This scale was particularly developed for use among older adults; although all participants in the proposed study will not be age 65 or over, patients with knee OA typically have more limited physical activity than the general population. Therefore we believe this scale will be more applicable to our participant group than scales that were developed for younger adults.~The typical range for the total PASE score is 0-400, with higher scores indicating greater activity."|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319546|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale|The Brief Fear of Movement Scale is a six item scale for assessing fear of movement in OA. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from “strongly agree” to “strongly disagree.” The score ranges from 0-24 with higher scores indicating more fear of movement.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319547|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument|The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days, This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 33.1-77.8; higher scores indicate worse fatigue.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319548|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument|The PROMIS adult sleep related impairment item bank focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past seven days. This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 30.5-77.6; higher scores indicate worse sleep impairment.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319549|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient’s opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319550|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8|Depressive symptoms and severity will be assessed using the PHQ-8, a reliable and valid measure of depression71. The PHQ-8 is an eight-item survey derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic tool, and consists of items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV). Each of the eight questions is scored as 0 (not at all) to 3 (nearly every day), so that total scores range from 0 to 24, with higher scores indicating more depressive symptoms.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319551|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the timed up and go, there are no minimum or maximum scores (participants complete the task as quickly as they are able); shorter (lower) times indicate better function.|baseline, 4 months, and 12 months||||seconds||95% Confidence Interval|Least Squares Mean
1319552|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 30 second chair stand test, the minimum is 0 stands and there is no maximum scale score (participants complete as many stands as they can in 30 seconds; greater numbers of stands indicate better function.|baseline, 4 months, and 12 months||||number of stands from a chair in 30 sec||95% Confidence Interval|Least Squares Mean
1319553|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the unilateral stand test, scores scan range from 0-10 seconds, with higher time indicating better balance.|baseline, 4 months, and 12 months||||seconds||95% Confidence Interval|Least Squares Mean
1319554|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 2 minute step test, the minimum is 0 steps and there is no maximum scale score (participants complete as many steps as they can in 2 minutes); greater steps indicate better function.|baseline, 4 months, and 12 months||||number of steps taken in 2 minutes||95% Confidence Interval|Least Squares Mean
1319555|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale|This is a validated, 5-item questionnaire that assesses patients’ satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying). All 5 items are rated on a 7 point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). The total scale ranges from -15 to +15,with higher scores indicating greater satisfaction with function.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319556|NCT02312713|Primary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score|Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1319557|NCT02312154|Primary|Global Aesthetic Improvement Scale (Subject)|The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse|12 weeks||||scores on a scale||Standard Deviation|Mean
1319558|NCT02312154|Primary|Global Aesthetic Improvement Scale (Investigator)|The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.|12 weeks||||scores on a scale||Standard Deviation|Mean
1319559|NCT02312154|Primary|Erythema Index|"We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany).~The range of erythema index is 0~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) ~999 AU (most erythematous possible)"|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
1319560|NCT02312154|Primary|Melanin Index|"We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany).~The range of melanin index was 0 (as bright as possible) ~999 AU (Arbitrary Unit) (most dark possible)."|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
1319561|NCT02312154|Primary|Elasticity|"We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany).~The range of elasticity was 0 (most elastic possible as) ~400 AU(Arbitrary Unit) (inelastic as possible)"|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
1319562|NCT02312154|Primary|Hydration Level|"We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany).~The range of hydration level was 0 (as dry as possible) ~120 AU (Arbitrary Unit)(most moist possible)"|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
1319563|NCT02311972|Other Pre-specified|Exploratory Outcome: Caregiver Satisfaction and Ease of Use|Describe the caregiver satisfaction and ease of use for the InnerSense by using a provider questionnaire. Caregivers will rate the InnerSense feeding tube with traditional feeding tubes used in the Intensive Care Nursery.|First 24 hours of infant life.|||||||
1319564|NCT02311972|Secondary|Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm.|Temperatures measured by the abdomen thermistor will be compared with esophageal temperatures in each infant over 24 hours using pearson correlation coefficient.|Admission to 24 hours of infant life.|Intervention Group Only: Two infants with the InnerSense did not have skin temperatures dowloaded from the data logger due to data logger malfunction and one infant had a Squirrel monitor attached to the InnerSense tube that did not read or log temperatures. Therefore only data from 5 infants was available to analyze.|||Pearson Correlation Coefficient|||Number
1323314|NCT02226198|Secondary|TC (mmol/L)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
1319566|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 4 hours to determine the percentage of hypothermia in both groups.|4 Hours of Infant Life||||Participants|||Count of Participants
1319567|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 1 hour to determine the percentage of hypothermia in both groups.|1 Hour of Infant Life||||Participants|||Count of Participants
1319568|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared on admission to determine the percentage of hypothermia in both groups.|Admission||||Participants|||Count of Participants
1319569|NCT02311972|Primary|Mean Axillary Temperature at 4 Hours of Infant Life|The mean axillary temperature at 4 hours of age will be compared for infants in the InnerSense group and the standard of care group to determine if a significant difference is seen at 4 hours of life.|4 Hours of Infant Life||||Degrees Celsius||Standard Deviation|Mean
1319570|NCT02311972|Primary|Mean Axillary Admission Temperature|Mean axillary temperatures upon Admission from infants in the InnerSense group and the standard of care group will be compared to determine if a significant difference|Admission||||Degrees Celsius||Standard Deviation|Mean
1319571|NCT02311907|Secondary|Times to Onset of CTCAE Grade 3+ PN|Time to grade 3+ CIPN between GSH and placebo arms.|Up to 5 years from registration||||days||95% Confidence Interval|Median
1319572|NCT02311907|Secondary|Times to Onset of CTCAE Grade 2+ PN|Compare time to grade 2+ CIPN between GSH and placebo arms.|Up to 1 year|Number of Participants analyzed is 93 for Arm I due to error in date entered.|||days||Standard Error|Median
1319573|NCT02311907|Secondary|Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale|Proportion of grade 2+ and grade 3+ chemotherapy induced peripheral neuropathy (CIPN) at any time during or at the end of the TAXOL/CBDCA based chemotherapy between GSH and placebo arms. Neuropathy scale has grades 1 through 5 (1-mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening and Grade 5 Death related to AE).|Up to 1 year||||percentage of participants|||Number
1319574|NCT02311907|Secondary|Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN|Proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.|Up to 1 year||||percentage of participants|||Number
1319575|NCT02311907|Secondary|Percentage of Patients Delaying PC Chemotherapy Secondary to PN|Patients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.|Up to 1 year||||Percentage of participants|||Number
1319576|NCT02311907|Secondary|Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms|Descriptive statistics will be used to describe TAXOL/CBDCA acute pain syndrome incidence/severity between GSH and placebo arms. Pain was scored on a scale from 0-10, where 0 = ‘No aches or pains’ and 10 = ‘Aches or pains as bad as can be.’|Up to 1 year||||units on a scale||Full Range|Median
1319577|NCT02311907|Secondary|Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.|Quality of life was measured by FACT-O (on a 0 to 100 scale, higher scores represent better life quality) from baseline and at the end of TAXOL/CBDCA. The change in Quality of Life was calculated as the difference between baseline measure and end of treatment measure (with range from -100 to 100). A negative change represents a worsening in QOL from baseline to one year. Abbreviations used: Change from Baseline (chg from bsl)|Baseline to 1 year|FACT-O Change from Baseline to cycle 6 data available for 34 patients.|||units on a scale||Full Range|Median
1319578|NCT02311907|Secondary|Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)|A log-rank test and a Kaplan-Meier curve will be used to compare the recurrence free survival between GSH and placebo arms (for ovarian/fallopian tube/primary peritoneal patients only).|Up to 1 year|Patients without clinical evidence of disease.|||Median survival time in days||95% Confidence Interval|Median
1319579|NCT02311907|Primary|Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)).|The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale (higher scores indicated less symptoms and better quality of life). Generalized linear models (repeated measures analysis of variance [ANOVA] if data are complete) will be used to compare the CIPN between Glutathione (GSH) and placebo arms.|Every 28 day cycle, up to 6 cycles.||||Units on a scale 1-100||Standard Error|Least Squares Mean
1319580|NCT02311881|Secondary|Patient Global Assessment of Response to Therapy (PGART)|The PGART is a global assessment of the participant’s response to therapy, was measured using on a 5 point Likert scale as follows: 0=None (no good at all, ineffective), 1= Poor (some effect, but unsatisfactory), 2= Fair (reasonable effect, but could be better), 3= Good (satisfactory effect with occasional episodes of pain and/or stiffness), 4= Excellent (ideal response, virtually pain-free). Mean PGART scores from 5 point Likert scale was calculated periodically (at Week 4, Week 8, Week 12) for the 12 week treatment period.|Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||score on a scale||Standard Deviation|Mean
1319601|NCT02310789|Primary|Change in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Dependent Sweat Rate|CFTR-dependent sweat rate (C-sweat) was analyzed using a linear mixed model, combining on- and off-ivacaftor data.|Up to 79 days|Participants with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1319603|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56||Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
1319581|NCT02311881|Secondary|Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI)|Chronic Pain Sleep Inventory (CPSI) was assessed, based on the three questions: CPSI-1-'Trouble falling asleep': How often the participant had trouble falling asleep? , CPSI-3-'Awakening due to pain at night': How often the subject was awakened by pain during the night, CPSI-4- Awakening due to pain in the morning': How often the participant was awakened by pain in the morning? The participants responded to these questions via 0-100mm VAS, ranging from 0 (never) to 100 (always). Sleep problem index (SPI) was calculated as mean of these three CPSI questions, ranging from 0 (never affected by pain during sleep) to 100 (always affected by pain during sleep).|Baseline, Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified.|||mm||Standard Deviation|Mean
1319582|NCT02311881|Secondary|Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks|Participants recorded use of rescue medication daily in their patient diary. The mean number of doses of rescue medications taken per day during the 12-week treatment period was calculated.|every day up to 12 weeks|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified.|||number of rescue medication pills/day||Standard Deviation|Mean
1319583|NCT02311881|Secondary|Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12|Participants assessed their daily pain and stiffness each morning (upon awakening) during the 12-week treatment period using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain / no stiffness) to 10 (extreme pain / extreme stiffness). Composite daily pain/stiffness score was calculated as sum of scores of pain and stiffness each morning divided by 2, ranging from 0 (no pain/stiffness) to 10 (extreme pain/stiffness). The mean of pain, mean of stiffness, and mean pain /stiffness composite score was calculated. Change from baseline was calculated as the difference between Daily Pain, stiffness and composite score each morning with that at baseline and was presented per week. A negative change from Baseline indicated improvement.|Baseline, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||score on a scale||Standard Deviation|Mean
1319584|NCT02311881|Secondary|Number of Participants Classified as Responder|A participant was considered a “responder” if his/her improvement from baseline (change from baseline at week 12) satisfied at least one of the two criteria high’ or ‘moderate’ improvement as follows:- High improvement: 50% improvement from baseline in the last available WOMAC pain score or 60% improvement from baseline in the last available WOMAC physical function score. Moderate improvement: Fulfills two out of three criteria: 30% improvement from baseline in the last available WOMAC Pain score, 20% improvement from baseline in the last available WOMAC Physical Function score, 25% improvement from baseline in the last available GPAOA.|Baseline, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||participants|||Number
1319585|NCT02311881|Secondary|Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA)|"Participants performed an instantaneous GPAOA via a 0-100mm VAS, ranging from 0 (best ever) to 100 (worst ever) with respect to With respect to your arthritis condition, how would you describe yourself now? GPAOA was calculated periodically during the 12 week treatment period."|Baseline, Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||mm||Standard Deviation|Mean
1319586|NCT02311881|Secondary|Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 100=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 100=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 100=extreme stiffness). WOMAC Total Index was calculated at baseline and each time point as sum of scores of all 24 WOMAC questions divided by 2400, ranging from 0 (no pain/difficulty/stiffness) to 1 (extreme pain/ difficulty/stiffness). Change from baseline was calculated as WOMAC Total Index at specific time point minus WOMAC Total Index at baseline. A negative change from Baseline indicated improvement.|Baseline up to week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||mm||Standard Deviation|Mean
1319602|NCT02310776|Primary|Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)|Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians|Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.|Each participant was evaluated based on Breast Imaging-Reporting and Data System (BI-RADS) assessment for Automated and Handheld breast ultrasound exams. If participant had more than one lesion, each lesion was assessed and listed separately and if a participant did not have a lesion, she was entered once.|||Detection ratio of lesions|Participants|95% Confidence Interval|Number
1319709|NCT02308787|Other Pre-specified|Patient's WBC Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||cells x 10^9/L|Participants|Standard Deviation|Mean
1319587|NCT02311881|Secondary|Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC stiffness was measured using VAS ranging from 0mm (no stiffness) to 100mm (maximum stiffness) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 2 WOMAC stiffness categories: 1- after awakening in the morning; 2- later in the day. Mean WOMAC stiffness was calculated for baseline and each time point (sum of scores for 2 stiffness categories divided by 2). Change from baseline was calculated for each visit as mean WOMAC stiffness subscale score at specific time point minus mean WOMAC stiffness subscale score at baseline. A negative change from Baseline indicated improvement. The time-weighted mean change from baseline was calculated as area under the curve of change from baseline divided by nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||mm||Standard Deviation|Mean
1319588|NCT02311881|Secondary|Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Physical function was measured using VAS ranging from 0mm (no difficulty) to 100mm (extreme difficulty) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 17 WOMAC Physical function categories. Mean WOMAC Physical function was calculated for baseline and each time point (sum of scores for 17 physical function categories divided by 17). Change from baseline was calculated for each visit as mean WOMAC physical function subscale score minus mean baseline WOMAC physical function subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||mm||Standard Deviation|Mean
1319589|NCT02311881|Primary|Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Pain was measured using visual analogue scale (VAS) ranging from 0mm (no pain) to 100mm (extreme pain) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 5 WOMAC Pain items: 1-walking on flat, 2-going up down stairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. Mean WOMAC Pain subscale score was calculated at each visit as the sum of 5 pain category scores divided by 5. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to week 12|Modified intent to treat (mITT) population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||millimeter(mm)||Standard Error|Least Squares Mean
1319590|NCT02311309|Secondary|Lowest Hemoglobin|lowest peroperative hemoglobin concentration|one day|||||||
1319591|NCT02311309|Secondary|Preoperative Anemia|proportion of patients with preoperative anemia|one day|||||||
1319592|NCT02311309|Secondary|Transfusions|transfusion pattern in the whole cohort|one day||||number of participants|||Number
1319593|NCT02311309|Primary|Unanticipated Bleeding|From arrival in operating room until the patients leave post anesthesia care unit|one day||||percentage of participants|||Number
1319594|NCT02311153|Secondary|Presence or Absence of Airway Complications||Start of surgery through hospital discharge (approximately 6 hours)|Participants that started the study were analyzed.|||Participants|||Count of Participants
1319595|NCT02311153|Secondary|Post-op Pain Med Requirements|Recording pain medications given to patient as noted in the recovery room records and medication administration record|48 hour medicine requirement|Participants that started the study were analyzed. Data was missing for 5 participants in the Endotracheal intubation arm and 7 participants in the Laryngeal mask airway arm.|||Participants|||Count of Participants
1319596|NCT02311153|Secondary|Presence of Laryngeal Spasm|As recorded in anesthesia care record|From start of anesthesia through hospital discharge (approximately 6 hours)||||Participants|||Count of Participants
1319597|NCT02311153|Secondary|Recovery Time in Minutes|Minutes spent in recovery room as recorded in the recovery room record|time spent in recovery room after surgery (approximately 4 hours)|Participants that started the study were analyzed.|||minutes||Full Range|Mean
1319598|NCT02311153|Secondary|Anesthesia Time in Minutes|Start and stop time of anesthesia as recorded in anesthesia record|beginning and end of anesthesia (approximately 2 hours)||||minutes||Full Range|Mean
1319599|NCT02311153|Primary|Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score|Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).|intraoperative, within about 1 hour|Participants that started the study were analyzed. Data was missing for 1 participant in each arm.|||Participants|||Count of Participants
1319600|NCT02310789|Secondary|Change Sweat Chloride Production|Sweat chloride concentration was measured via the traditional sweat collection methods using the pilocarpine stimulation with the Macroduct device.|Up to 79 days|Participants with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1319710|NCT02308787|Other Pre-specified|Patients WBC Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure||||cells x 10^9/L|Participants|Standard Deviation|Mean
1319604|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28||Baseline, Day 4, 8, 10, 11, 14, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
1319605|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8||Baseline, Day 2, 5, 8|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
1319606|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56||Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
1319607|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28||Baseline, Day 4, 8, 10, 11, 14, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
1319608|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8||Baseline, Day 2, 5, 8|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells per millimeter cube (cells/mm^3)||Standard Deviation|Mean
1319609|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1319610|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline, Day 2, 5, 10, 11, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1319611|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1319612|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56|Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.|Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||pg/mL||Standard Deviation|Mean
1319613|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28|Serum samples for IP-10 were analyzed using a validated analytical assay. LLOQ for IP-10 was 10 pg/mL.|Baseline, Day 2, 5, 10, 11, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||pg/mL||Standard Deviation|Mean
1319614|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline|Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.|Baseline|Pharmacodynamic (PD) analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
1319615|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Renal Clearance|Renal clearance was calculated as amount of drug recovered unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hours on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
1319616|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%)|Aetau% was calculated as: 100*Aetau/dose. Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hours on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||percentage of dose recovered||Geometric Coefficient of Variation|Geometric Mean
1319617|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau)|Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hour on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||milligram||Geometric Coefficient of Variation|Geometric Mean
1319618|NCT02310750|Secondary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841|PTF was calculated as: Cmax-Cmin/Cavg. Cmax is the maximum observed plasma concentration of PF-06700841. Cmin is the minimum observed plasma concentration of PF-06700841. Cavg is the average observed plasma concentration of PF-06700841 calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.|MAD: pre­-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post­-dose on Day 10; MAD Psoriasis: pre­-dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1319619|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. CL/F =Dose of PF-06700841/AUCinf.|SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1319620|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||liter||Standard Deviation|Mean
1319621|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841|MRT= AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.|SAD: pre­-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre­-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post­-dose on Day 10; MAD Psoriasis: pre­-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||hour||Geometric Coefficient of Variation|Geometric Mean
1319622|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841|Plasma decay half-life is the time measured for the plasma concentration of PF-06700841 to decrease by one half.|SAD: pre-­dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post-dose on Day 1; MAD: pre­-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre­-dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||hour||Standard Deviation|Mean
1319623|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of of PF-06700841 (in mg) administered to a participant.|pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||[ng*hr/mL]/mg||Geometric Coefficient of Variation|Geometric Mean
1319624|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast(dn) was calculated by dividing AUClast by the exact dose of of PF-06700841 (in mg) administered to a participant.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.|||[ng*hr/mL]/mg||Geometric Coefficient of Variation|Geometric Mean
1319625|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06700841 (in mg) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.|||[nanogram*hour/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
1319626|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841|Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF 06700841 (in mg) administered to a participant.|SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||[nanogram/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
1319627|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1319628|NCT02310750|Secondary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841|Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.|MAD: pre­dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post­dose on Day 10; MAD Psoriasis: pre­dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1319629|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1319630|NCT02310750|Secondary|Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-­06700841||Pre-­dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1319631|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841||SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm|||hour||Full Range|Median
1319632|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841||SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1319633|NCT02310750|Primary|Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841||pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1319634|NCT02310750|Primary|Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1319711|NCT02308787|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||cells x 10^3/L|Participants|Standard Deviation|Mean
1319635|NCT02310750|Primary|Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1319636|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||mL/min||Standard Deviation|Mean
1319637|NCT02310750|Primary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mL/min||Standard Deviation|Mean
1319638|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milliliter per minute (mL/min)||Standard Deviation|Mean
1319639|NCT02310750|Primary|Number of Participants With Laboratory Abnormalities|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: <0.9*LLN,>1.1*upper limit of normal (ULN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN)|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
1319640|NCT02310750|Primary|Number of Adverse Events (AEs) According to Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild – AEs does not interfere with participant’s usual function b) moderate – AEs interferes to some extent with participant’s usual function c) severe – AEs interferes significantly with participant’s usual function.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||adverse events|||Number
1319641|NCT02310750|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the end of study (up to Day 8 in SAD cohort, Day 28 in MAD cohort, Day 56 in MAD Psoriasis cohort, Day 37 in Food effect cohort), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
1319642|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
1319643|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
1319644|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||bpm||Standard Deviation|Mean
1319645|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
1319712|NCT02308787|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||cells x 10^3/L|Participants|Standard Deviation|Mean
1319646|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||msec||Standard Deviation|Mean
1319647|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||millisecond (msec)||Standard Deviation|Mean
1319648|NCT02310750|Primary|Number of Participants With Change From Baseline in Physical Examinations|Physical examinations included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
1319649|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||degrees celsius||Standard Deviation|Mean
1319650|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||degree celsius||Standard Deviation|Mean
1319651|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||degree celsius||Standard Deviation|Mean
1319652|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
1319653|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
1319654|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
1319655|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mmHg||Standard Deviation|Mean
1319656|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mmHg||Standard Deviation|Mean
1319657|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1||Baseline, 24 hours post-dose on Day 1|Full analysis set (FAS) included all participants who were randomized to treatment and received at least 1 dose of study medication.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1319658|NCT02310646|Other Pre-specified|Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2|Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel)|Baseline to Week 2|In total 103 preferred foam and 105 preferred gel. 4 subjects ...|||percentage of subjects|||Number
1319659|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments|The VPM questionnaire was analysed the same way as the TPUQ. Numeric scores were calculated by assigning the following values to each response category: -3 = Extremely unappealing, -2 = Moderately unappealing, -1 = Slightly unappealing, 0 = Neutral, 1 = Slightly appealing, 2 = Moderately appealing, 3 = Extremely appealing. A summary score was defined as the sum of all questions and could range from -21 to 21.|At Week 1 and Week 2||||units on a scale||Standard Deviation|Mean
1319660|NCT02310646|Other Pre-specified|Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)|"Subjects in both arms (foam-gel; gel-foam) indicated whether they preferred latest topical treatment, LEO 90100 aerosol foam, Daivobet® gel, or did not have any preference.~The subjects compared the trial treatment used the previous week with the latest topical treatment (used within 3 months prior to baseline; CLTT analysis set). Each item was scored with either ‘prefer latest treatment’, ‘no preference’, or ‘prefer trial medication (foam or gel)’. A subject could prefer both study treatments over the latest topical treatment. The percentage is given for the number of subjects preferring foam and number of subjects preferring gel."|At Week 1 and Week 2|CLTT analysis set was defined by including all randomised subjects who had used topical anti-psoriatic medication on the treatment area (trunk and/or limbs) within 3 months prior to Baseline.|||percentage of subjects|||Number
1319713|NCT02308787|Primary|Adverse Events||during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.|||Number of subjects with at least 1 AE|||Number
1319661|NCT02310646|Other Pre-specified|Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments|"The TPUQ tool was used to evaluate the subject’s latest topical treatment at Baseline (used within 3 months prior to baseline). TPUQ assessments of trial treatments at Week 1 and Week 2.~Each response category (item 1 to 25) was assigned a numeric score from-2=strongly disagree to 2=strongly agree. For item 26 the assigned scores were from -2=very dissatisfied to 2=very satisfied.~Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6).~For each subject and each item, the latest topical treatment score was compared with each study treatment by calculating the difference between the scores, i.e., by subtracting the latest topical treatment score from each study medication score. The higher score signifies higher preference in that domain."|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1319662|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments|"Each response category (item 1 to 25) was assigned a numeric score (-2=strongly disagree, -1=slightly disagree, 0=neither agree nor disagree, 1=slightly agree, 2=strongly agree). For item 26, the assigned score were from -2=very dissatisfied to 2=very satisfied.~Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). Positive scores indicate agreement with domains’ items.~A total TPUQ summary score (item 1-25; score range -50 to +50) was also calculated. The summary scores were analysed in the same way as the individual questions. The higher score signifies higher preference in that domain."|2 weeks||||units on a scale||Standard Deviation|Mean
1319663|NCT02310646|Primary|Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics|"The SPA questionnaire was completed at Week 2 and consisted of 2 parts:~(i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from ‘very important factor’ to ‘not at all important factor’.~The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website."|2 weeks||||percentage of subjects|||Number
1319664|NCT02310581|Secondary|Percentage of Participants Who Used Rescue Medication for Pain|The percentage of participants who needed to take an alternate medication for pain relief during the study.|From Time 0 (first dose of study drug) up to Day 9|ITT Population included all participants who were randomized.|||percentage of participants|||Number
1319665|NCT02310581|Secondary|NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 24 hours after Time 0|ITT Population included all participants who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1319666|NCT02310581|Secondary|NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 8 hours after Time 0|ITT Population included all randomized participants.|||units on a scale||Standard Error|Least Squares Mean
1319667|NCT02310581|Secondary|NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 4 hours after Time 0|ITT Population included all participants who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1319754|NCT02307526|Primary|Systolic Blood Pressure||Average systolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.||||mm Hg||Standard Deviation|Mean
1319668|NCT02310581|Secondary|NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
1319669|NCT02310581|Secondary|NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline – pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.|Baseline and 4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
1319670|NCT02310581|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population.|||units on a scale||Standard Error|Least Squares Mean
1319671|NCT02310568|Secondary|Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores|Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8|Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a <50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of >= 16 at Week 4.|||percentage of participants|||Number
1319672|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1319673|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1319674|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 2|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8|Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng/mL||Standard Deviation|Mean
1319675|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 1|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng/mL||Standard Deviation|Mean
1319715|NCT02308787|Primary|Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure|(PLTpre - PLTpost) / PLTpre x 100%|on average this will be within 15 minutes after the end of the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||% change in PLT count in subject blood|Participants|Standard Deviation|Mean
1319676|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, “Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?” Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1319677|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1319678|NCT02310568|Secondary|Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2|A responder was defined as a participant with >= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1319679|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 1, 2, 3|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1319680|NCT02310568|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1319681|NCT02310568|Secondary|Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1319682|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 5, 6, 7, 8|Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) < 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of >=16 at Week 4. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1319683|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1319753|NCT02307526|Primary|Diastolic Blood Pressure||Average diastolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.||||mm Hg||Standard Deviation|Mean
1319684|NCT02310568|Primary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 4|Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1319685|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (>=)16 at Week 4.|||units on a scale||Standard Deviation|Mean
1319686|NCT02310126|Primary|Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.|CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|15 minutes post Contact Lens Insertion|The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.|||units on a scale||Standard Deviation|Mean
1319687|NCT02309723|Primary|Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures|Proportion of respondents who recommend that the patient's spouse take actions that would be appropriate if the patient has Alzheimer's disease, including: (1) discussion of advance care planning, (2) monitoring of patient's finances, (3) assessment of how compatible the patient's job is with his conditions, (4) the initiation of precautions to ensure the patient is properly taking his medications to manage hypertension and hyperlipidemia.|Online Survey - completion during the estimated 2-3 month field period||||participants|||Number
1319688|NCT02309723|Primary|Likelihood of Recommending a Medication Indicated for Alzheimer's Disease|Proportion of respondents who recommend a medication indicated for the treatment of Alzheimer's Disease, including Acetylcholinesterase inhibitors, N-methyl-D-aspartate receptor antagonists, Typical antipsychotics – e.g., Chlorpromazine (Thorazine), Haloperidol (Haldol), Atypical antipsychotics – e.g., Clozapine (Clozaril), Risperidone (Risperdal), Antidepressant – e.g., Citalopram (Celexa), Venlafaxine (Effexor), Antianxiety agent – e.g. Benzodiazepines, Buspirone (Buspar).|Online Survey - completion during the estimated 2-3 month field period||||participants|||Number
1319689|NCT02309723|Primary|Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss|Proportion of respondents who identify Alzheimer's Disease as the sole or a contributing factor that is responsible for the patient's cognitive complaint.|Online Survey - completion during the estimated 2-3 month field period||||participants|||Number
1319690|NCT02309411|Other Pre-specified|Anti-factor Xa Values at Specified Time Points|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. The anti-factor Xa assay is designed to measure plasma heparin, low molecular weight heparin and other anticoagulants. In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)|PDS included all subjects with at least one blood sample for clotting tests in accordance with the pharmacodynamic sampling strategy was included.|||microgram per liter (mcg/L)||Standard Deviation|Mean
1319691|NCT02309411|Secondary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points|Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)|PKS included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
1319692|NCT02309411|Secondary|Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. Day 30 (10-16 hours post-dose) was considered as a baseline.|Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)|PDS with evaluable subjects for this end point. PD parameters were evaluated only for subjects who received active study medication.|||Seconds||Standard Deviation|Mean
1319693|NCT02309411|Secondary|Change From Baseline in Prothrombin Time at Specified Time Points|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. Day 30 (10-16 hours post-dose) was considered as a baseline.|Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)|PDS with evaluable subjects for this end point. PD parameters were evaluated only for subjects who received active study medication.|||Seconds||Standard Deviation|Mean
1319714|NCT02308787|Primary|Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.|(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)|on average this will be within 15 minutes after the end of the procedure|At Site 2, percent processed platelets could only be calculated for 1 procedure in Subject 214; no waste bag (depletion product) platelet counts were available for the other 9 procedures performed at Site 2.|||% of processed platelets|Participants|Standard Deviation|Mean
1319694|NCT02309411|Secondary|Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging|The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects.|At the end of the 30-day treatment period|FAS included all enrolled children (before Amendment 4, all children were randomized by interactive voice/web response system [IxRS], after Amendment 4 all children were assigned to rivaroxaban by IxRS). Screening failures were excluded.|||Participants|||Count of Participants
1319695|NCT02309411|Secondary|Number of Subjects With Symptomatic Recurrent Venous Thromboembolism|Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test.|From start of the study treatment up to 30-days post study treatment period (approximately 60 days)|FAS included all enrolled children (before Amendment 4, all children were randomized by interactive voice/web response system [IxRS], after Amendment 4 all children were assigned to rivaroxaban by IxRS). Screening failures were excluded.|||Participants|||Count of Participants
1319696|NCT02309411|Primary|Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events|"Major bleeding is defined as overt bleeding and:~associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or~leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or~occurring in a critical site, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or~contributing to death.~Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:~medical intervention, or~unscheduled contact (visit or telephone call) with a physician, or~cessation (temporary) of study treatment, or~discomfort for the child such as pain or~impairment of activities of daily life (such as loss of school days or hospitalization)."|During or within 2 days after stop of study treatment (up to 32 days)|SAF included all subjects who received at least one dose of the study medication.|||Participants|||Count of Participants
1319697|NCT02309294|Primary|Number of Subjects That Showed no Significant Irritation|Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).|14 days||||participants|||Number
1319698|NCT02309112|Secondary|Patient Adherence Rate to Yoga Intervention|% of patients who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||percentage of participants|||Number
1319699|NCT02309112|Other Pre-specified|Patient's Health-related Quality of Life|Assessed via an online survey of a validated, cancer-specific survey instrument measuring health-related quality of life (QOL-CA/CS), (0 worst; 10 best possible). The QOL-CA/CS score was assessed pre and post yoga intervention.|6 weeks|Male (n=3) and female (n=9) adults undergoing conventional treatment for cancer diagnosis in Vancouver, Canada.|||units on quality of life scale||Full Range|Mean
1319700|NCT02309112|Other Pre-specified|Financial Cost of Delivering Yoga Intervention in a Clinical Setting|Calculation of the per participant cost of three types of yoga interventions (Group A, B and C). The financial data included cost of in-person instruction, cost of materials and time to design and implement intervention per participant in each yoga group.|10 weeks|Male (n=3) and female (n=10) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||dollars (USD)|||Number
1319701|NCT02309112|Other Pre-specified|Patient Acceptability of Yoga Intervention|Amount of satisfaction for adult cancer patients assessed via Likert-scale surveys; on scale of 1 to 10, 1 being not satisfied; 10 being extremely satisfied (i.e higher number, better outcome).|6 weeks|Adult male (n=3) and female (n=9) cancer patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||units on satisfaction scale||Full Range|Mean
1319702|NCT02309112|Secondary|Patient Adherence to Yoga Intervention|Number of participants who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||participants|||Number
1319703|NCT02309112|Primary|Feasibility of Patient Recruitment to Yoga Intervention|Number of participants eligible for randomization to yoga intervention during cancer treatment|10 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment in Vancouver, Canada for a cancer diagnosis; who have not participated in yoga the past month.|||participants|||Number
1319704|NCT02308787|Other Pre-specified|Total Blood Volume (TBV) Processed|The number of times the patient's total blood volume is processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||Number of TBVs processed|Participants|Standard Deviation|Mean
1319705|NCT02308787|Other Pre-specified|Waste Bag Volume||Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||mL|Participants|Standard Deviation|Mean
1319706|NCT02308787|Other Pre-specified|Procedure Duration||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||minutes|Participants|Standard Deviation|Mean
1319707|NCT02308787|Other Pre-specified|Average Inlet Flow Rate||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||mL/min|Participants|Standard Deviation|Mean
1319708|NCT02308787|Other Pre-specified|Whole Blood Processed (mL)|Volume of patients blood processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||mL|Participants|Standard Deviation|Mean
1319791|NCT02305277|Secondary|Tmax - Time of Occurrence of Cmax||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose||||hours||Full Range|Median
1319716|NCT02308748|Secondary|Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day.|Evening dose (moxifloxacin+diltiazem) versus afternoon dose (diltiazem alone).|5 weeks|All study participants that completed placebo, moxifloxacin and moxifloxacin + diltiazem|||ms||95% Confidence Interval|Mean
1319717|NCT02308748|Primary|Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day|After 3rd dose of mexiletine or lidocaine (evening dose) on treatment day when combined with dofetilide to evening dose on dofetilide alone day.|5 weeks|All study participants that completed placebo and dofetilide alone as well as dofetilide + mexiletine and/or dofetilide + lidocaine|||ms||95% Confidence Interval|Mean
1319718|NCT02308475|Secondary|Radiation Dose|Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.|1 Day|The planned statistical analyses were not performed.||||||
1319719|NCT02308475|Secondary|CTMP/SPECT MPI Disagreement|Evaluate the accuracy of CT myocardial perfusion and SPECT using a stress/rest and delayed enhancement MRI examination as gold-standard by means of Kappa analysis|1 Day|The planned statistical analyses were not performed.||||||
1319720|NCT02308475|Primary|Diagnostic Accuracy of Dynamic Perfusion CT|The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test.|1 Day|The planned statistical analyses were not performed.||||||
1319721|NCT02308371|Secondary|Number of Days in the PICU|Number of days for admission pediatric critical care unit (admission during which subject was enrolled into the study)|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)||||days||Standard Deviation|Mean
1319722|NCT02308371|Secondary|Number of Days on Ventilatory Support|Number of days subject was on ventilatory support (during time of subject enrollment) to the pediatric critical care unit. This included subjects that were intubated or was on a ventilator with a tracheotomy|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)||||days||Standard Deviation|Mean
1319723|NCT02308371|Secondary|Number of Hours on Vasopressors|Hours that a subject remained intubated during pediatric intensive care admission during subject recruitment|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)||||hours||Standard Deviation|Mean
1319724|NCT02308371|Primary|Total Fluid Bolused|Total fluid bolused within 48 hours after enrollment.|48 hours after enrollment||||ml/kg||Standard Deviation|Mean
1319725|NCT02308371|Primary|Total Fluid (ml/kg/Day) Given|Total fluid (ml/kg/day) given during the first 48 hours of enrollment|First 48 hours after enrollment||||ml/kg/day||Standard Deviation|Mean
1319726|NCT02308189|Secondary|Muscle Endurance (Time to Task Failure) % of Change|Time for successfully performing a sustained, submaximal muscle contraction|Baseline and following 10-weeks of exercise training. Values are calculated on % of change.|Study participants completing study.|||percentage of change from baseline||Standard Deviation|Mean
1319727|NCT02308189|Secondary|Muscle Strength % of Change|Maximal muscle strength|Baseline and following 10-weeks of exercise training. Values calculated are % of change|Study participants completing study.|||percentage of change from baseline||Standard Deviation|Mean
1319728|NCT02308189|Primary|Trunk Extensor Muscle Cross Sectional Area % of Change|The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.|Baseline and following 10-weeks of exercise training. Values are calculated from % change.|Per protocol analysis of completed study participants|||percentage of change||Standard Deviation|Mean
1319729|NCT02308124|Secondary|Changes in Health-related Quality of Life|"changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS)~SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores."|changes at 3 months after treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
1319730|NCT02308124|Secondary|Changes in Health-related Quality of Life|"changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline~SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores."|changes at 3 months after treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
1319731|NCT02308124|Secondary|Change of the Depression Score (Beck Depression Inventory-II )|"Change of the depression score after 3-month medical treatment compared to initial results.~21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression.~Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63"|after 3-month medical treatment.|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
1319755|NCT02307318|Secondary|Incidence of Hematoma and/or Ecchymosis|Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.|Day1||||Participants|||Count of Participants
1319732|NCT02308124|Secondary|Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).|"Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results.~OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity.~** OHQ total score minimal 0 ~ maximal 100"|after 3-month medical treatment.|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
1319733|NCT02308124|Primary|Change in Orthostatic BP Drop|Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.|after 3-month medical treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||mmHg||Standard Deviation|Mean
1319734|NCT02307838|Secondary|Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters|The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.|10 years|The FAS was considered for the analysis. Only participants who had 10 year correlation measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||Pearson correlation coeffcient|||Number
1319735|NCT02307838|Secondary|Percentage Brain Volume Change (PBVC)|PVBC was assessed by MRI. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||Percent change||Standard Deviation|Mean
1319736|NCT02307838|Secondary|Change From Baseline in Third Ventricle Diameter|Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for analysis. Only participants who had both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm||Standard Deviation|Mean
1319737|NCT02307838|Secondary|Third Ventricle Diameter|Third ventricle diameter was assessed by MRI.|10 years|The FAS was considered for the analysis. Only participants with 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm||Standard Deviation|Mean
1319738|NCT02307838|Secondary|Change From Baseline in Total Volume of T2 Lesion|Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants from the FAS who had both baseline and 10 years measurements were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm^3||Standard Deviation|Mean
1319739|NCT02307838|Secondary|Total Volume in T2 Lesion|Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).|10 years|The FAS was considered for the analysis. Only participants with measurements at 10 years were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm^3||Standard Deviation|Mean
1319740|NCT02307838|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score|MSFC is a composite measure encompassing information from the nine-hole peg test (arm dimension), timed 25 foot walk (leg dimension) and PASAT. The MSFC composite Z score was calculated as follows: (1) the average scores from the four trials on the 9-HPT (the two trials for each hand were averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals were averaged); (2) the average scores of two 25-Foot Timed Walk trials; (3) the number correct from the PASAT-3. The MSFC is based on the concept that scores for these three dimensions—arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This was done by creating Z-scores for each component of the MSFC, and averaging them to create an overall composite Z score.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline measurements for each MSFC component and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||Z score||Standard Deviation|Mean
1319741|NCT02307838|Secondary|Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score|The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||score on a scale||Standard Deviation|Mean
1319756|NCT02307318|Secondary|Changes in Circulation, Movement and Sensation|Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.|Day1||||Participants|||Count of Participants
1319742|NCT02307838|Secondary|Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is the last measure administered at each visit. It is presented on audio compact disc (CD) to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test result is the number of correct sums given (out of 60 possible). A positive change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||score on a scale||Standard Deviation|Mean
1319743|NCT02307838|Secondary|Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The time limit per trial is 300 seconds. The right and left hand scores were the time in seconds it took to insert and remove 9 pegs ((the average scores from the four trials on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged)). A negative change from baseline indicates improvement.|baseline from core study, CFTY720D2201 (NCT00333138), 10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||seconds||Standard Deviation|Mean
1319744|NCT02307838|Secondary|Percentage of Participants With First Use of a Wheelchair|First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.|10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Percentage of participants|||Number
1319745|NCT02307838|Secondary|Percentage of Participants With First Use of an Ambulatory Device|First use of an ambulatory device was considered from EDSS 6.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 6.0.|10 years|The FAS was considered for the analysis. Only participants with evaluable data were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Percentage of participants|||Number
1319746|NCT02307838|Secondary|Number of Participants Classified as Secondary Progressive MS (SPMS)|SPMS follows an initial relapsing-remitting course. Most people who are diagnosed with relapsing-remitting multiple sclerosis (RRMS) will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. Participants who were classified as SPMS were assessed.|10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
1319747|NCT02307838|Secondary|Number of Participants Not Using a Wheelchair or Being Bedridden|The number of participants not using a wheelchair or being bedridden was assessed.|10 years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
1319748|NCT02307838|Secondary|Number of Participants With EDSS <4 or <6|EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement.|10 years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
1319749|NCT02307838|Secondary|Number of Participants With Disability Progression|Disability progression is defined as: 1.5-point increase from baseline in participants with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in participants with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in participants with baseline EDSS score >5.0.|10 Years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
1319750|NCT02307838|Primary|Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)|EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||score on a scale||Standard Error|Least Squares Mean
1319751|NCT02307552|Primary|Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer|The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis|one year|Data were not collected because the study was discontinued due to lack of feasibility and negative results.||||||
1319752|NCT02307526|Primary|Heart Rate||Average heart rate of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees following pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.||||bpm||Standard Deviation|Mean
1319758|NCT02307318|Primary|Incidence of Arterial Bleeding|Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.|Day1||||Participants|||Count of Participants
1319759|NCT02307266|Primary|Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)|"To prevent bias, treatment adherence was assessed without subject’s knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100.~Analysis was performed on the worst-case population: Missing data were considered as non-adherence."|week 12|Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population.|||percentage of adherence||Standard Deviation|Mean
1319760|NCT02307188|Primary|Atrial Fibrillation Dominant Frequency|Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.|1 year|Because the quality of intracardiac electrogram data for the one patient to complete the study was not sufficient for analysis, this outcome measure was not analyzed.||||||
1319761|NCT02307123|Secondary|Glasgow Outcome Score (GOS)|GOS 1 = Death GOS 2 = Poor neurological outcome GOS 3 = Good neurological outcome Modified from the original 5 - step classification.|1 year||||percentage of good neurological outcome|||Number
1319762|NCT02307123|Primary|Mortality||1 year||||percentage of one year mortality|||Number
1319763|NCT02306928|Primary|50% fT>4xMIC: Free Piperacillin Concentration Maintained at a Level Fourfold the MIC for at Least 50% of the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||participants|||Number
1319764|NCT02306928|Secondary|Trough Piperacillin Plasma Concentration (Cmin)|Trough plasma concentration (Cmin) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||mg/L||Inter-Quartile Range|Median
1319765|NCT02306928|Secondary|The Area Under the Plasma-concentration Time Curve Concentration-time Curve From 0-8 Hours After the Studied Dose (AUC 0-8)|Area under the free plasma concentration-time curve (fAUC0-8) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||mg.hr/L||Inter-Quartile Range|Median
1319766|NCT02306928|Secondary|The Maximum Concentration of Piperacillin (Cmax)|Maximum plasma concentration was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||mg/L||Inter-Quartile Range|Median
1319767|NCT02306928|Primary|100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||participants|||Number
1319768|NCT02306759|Secondary|ED Length of Stay (Minutes)|ED Length of stay (minutes) throughout study period|throughout study completion||||minutes||Standard Deviation|Mean
1319769|NCT02306759|Secondary|Mean Consumption of Rescue Analgesia||at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)||||milligrams||Standard Deviation|Mean
1319770|NCT02306759|Secondary|Patient Satisfaction of Pain Control Based on a Likert Scale|Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.|At the end of study period||||units on a scale||Standard Deviation|Mean
1319771|NCT02306759|Secondary|Number of Participants With Adverse Events|Incidence or number of participants with adverse events.|during the study period|Nausea was reported in three patients who received placebo and one patient who received ketamine. Dreams was reported in 1 patient who received placebo and one patient who received ketamine.|||participants|||Number
1319772|NCT02306759|Primary|Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes|Change from Baseline of Pain as described by Numeric Rating Scale (NRS) [minimum:0, maximum 10] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.|15 minutes after administration of study intervention||||units on a scale||Inter-Quartile Range|Median
1319773|NCT02305446|Other Pre-specified|Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.|The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.|Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.|The analysis was performed on the all enrolled dataset.|||Participants|||Number
1319774|NCT02305446|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.|From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)|Analysis were evaluated on the Unsolicited Safety Set|||Subjects|||Number
1319775|NCT02305381|Secondary|HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target|Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.|After 30 weeks treatment|Full analysis set.|||percentage of subjects|||Number
1319776|NCT02305381|Secondary|HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target|Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.|After 30 weeks treatment|Full analysis set|||percentage of subjects|||Number
1319777|NCT02305381|Secondary|Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)|The DTSQs questionnaire was used to assess subjects’ treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening [<= 8.0% or > 8.0%] and use of metformin [yes or no]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.|week 0, week 30|Full analysis set|||scores on a scale||Standard Error|Least Squares Mean
1319778|NCT02305381|Secondary|Change in Systolic and Diastolic Blood Pressure|Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|week 0, week 30|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
1319779|NCT02305381|Secondary|Change in Insulin Dose|Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.|week 0, week 30|Full analysis set|||ratio||Standard Error|Least Squares Mean
1319780|NCT02305381|Secondary|Change in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|week 0, week 30|Full analysis set.|||mg/dL||Standard Error|Least Squares Mean
1319781|NCT02305381|Secondary|Change in Body Weight|Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|Week 0, week 30|Full analysis set.|||kg||Standard Error|Least Squares Mean
1319782|NCT02305381|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|Week 0, week 30|Full analysis set included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1319783|NCT02305329|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||h.ng/mL||Standard Deviation|Mean
1319784|NCT02305329|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t||before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||h.ng/mL||Standard Deviation|Mean
1319785|NCT02305329|Secondary|Tmax - Time of Occurrence of Cmax of 9-1067|tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||hours||Full Range|Median
1319786|NCT02305329|Primary|Cmax - Maximum Observed Plasma Concentration of 9-1067|Cmax - maximum observed plasma concentration of 9-1067.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||ng/mL||Standard Deviation|Mean
1319787|NCT02305316|Secondary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity|AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||ng.h/mL||Standard Deviation|Mean
1319788|NCT02305316|Secondary|Tmax - Time of Occurrence of Cmax of BIA 9-1067|tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||hours||Full Range|Mean
1319789|NCT02305316|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration|AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||ng.h/mL||Standard Deviation|Mean
1319790|NCT02305316|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||ng/mL||Standard Deviation|Mean
1319792|NCT02305277|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067|Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration|before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose||||ng.h/mL||Standard Deviation|Mean
1319793|NCT02305277|Primary|Cmax - Maximum Observed Plasma Concentration||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose||||ng/mL||Standard Deviation|Mean
1319794|NCT02305238|Secondary|Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52|Retinal and lesion characteristics were evaluated, using OCT, for the study eye at every visit. A participant was classified as without fluid if “Evidence of new or persistent fluid” on OCT was “No”.|Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||percentage of participants||95% Confidence Interval|Number
1319795|NCT02305238|Secondary|Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52||Baseline and week 52|The outcome measure is analyzed based on full analysis set (FAS) with number of subjects evaluable for this specific end point.|||um||95% Confidence Interval|Mean
1319796|NCT02305238|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52||Baseline and Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||percentage of participants||95% Confidence Interval|Number
1319797|NCT02305238|Secondary|Percentage of Participants Who Maintained Vision at Week 52|A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.|Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||percentage of participants||95% Confidence Interval|Number
1319798|NCT02305238|Primary|Mean Change From Baseline in BCVA at Week 52|Visual functions of the study eye (at every visit) were assessed, according to the ETDRS protocol as described in detail in the operation manual. A higher score represents better functioning.|Baseline and Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||letters||Standard Deviation|Mean
1319799|NCT02305017|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.|AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||ng.h/mL||Standard Deviation|Mean
1319800|NCT02305017|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification|AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||ng.h/mL||Standard Deviation|Mean
1319801|NCT02305017|Secondary|Tmax - Time of Occurrence of Cmax|Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||hours||Full Range|Mean
1319802|NCT02305017|Primary|Cmax - Maximum Plasma Concentration|Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||ng/mL||Standard Deviation|Mean
1319803|NCT02304926|Secondary|Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration|E-selectin was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||ng/ml||Standard Deviation|Mean
1319804|NCT02304926|Secondary|Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration|The intercellular adhesion molecule 1 (ICAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||ng/ml||Standard Deviation|Mean
1319805|NCT02304926|Secondary|Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration|The vascular cell adhesion molecule 1 (VCAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||ng/ml||Standard Deviation|Mean
1319806|NCT02304926|Primary|Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration|Levels of apolipoprotein B were determined by inmunonephelometry|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
1319807|NCT02304926|Secondary|Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy.The rolling velocity in the field of focus was determined by measuring the time required by 20 consecutive leukocytes to cover a distance of 100 μm.|Baseline, 4 weeks and 8 weeks||||micrometer/second||Standard Deviation|Mean
1319808|NCT02304926|Secondary|Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Adhesion was evaluated by counting the number of polymorphonuclear cells that maintained stable contact with human umbilical vein endothelial cells (HUVEC) for 30 seconds.|Baseline, 4 weeks and 8 weeks||||polymorphonuclear cells/mm2||Standard Deviation|Mean
1319809|NCT02304926|Primary|Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration|LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.|Baseline, 4 weeks and 8 weeks||||Angström||Standard Deviation|Mean
1319810|NCT02304926|Primary|Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration|Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
1319811|NCT02304926|Secondary|Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Leukocyte rolling was estimated as the number of leukocytes rolling over 100 μm2 of the endothelial monolayer during a 1-min period.|Baseline, 4 weeks and 8 weeks||||polymorphonuclear cells/min||Standard Deviation|Mean
1319812|NCT02304926|Secondary|Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (levels of glutathione (GSH)) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks||||Fluorescence Units||Standard Deviation|Mean
1319813|NCT02304926|Secondary|Membrane Potential Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (membrane potential) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks||||Fluorescence Units||Standard Deviation|Mean
1319814|NCT02304926|Secondary|Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (Reactive oxygen species (ROS) production) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks||||Fluorescence Units||Standard Deviation|Mean
1319815|NCT02304926|Secondary|Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (mitochondrial oxygen (O2) consumption) was measured at baseline and after treatment by Clark electrode|Baseline, 4 weeks and 8 weeks||||Nmol O2/min/million cells||Standard Deviation|Mean
1319816|NCT02304926|Primary|Triglycerides Before and After Simvastatin/Ezetimibe Administration|Triglyceride concentration were measured by enzymatic assay|Baseline, 4 weeks and 8 weeks||||mg/dl||Inter-Quartile Range|Median
1319817|NCT02304926|Primary|High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration|High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
1319818|NCT02304926|Secondary|Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (tumor necrosis factor α (TNF-α)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||pg/ml||Standard Deviation|Mean
1319819|NCT02304926|Secondary|Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (interleukin-6 (IL-6)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||pg/ml||Standard Deviation|Mean
1319820|NCT02304926|Secondary|Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration|Levels of high-sensitive C-reactive protein (hsCRP) were analysed by a latex-enhanced inmunonephelometric assay|Baseline, 4 weeks and 8 weeks||||mg/l||Standard Deviation|Mean
1319821|NCT02304926|Primary|Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration|Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald.|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
1319822|NCT02304926|Primary|Total Cholesterol Before and After Simvastatin/Ezetimibe Administration|Total cholesterol concentration was measured by enzymatic assay|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
1319823|NCT02304432|Secondary|Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)|Auditory evoked potential amplitude: P50 ratio (P50 S2/S1)|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||ratio|||Number
1319824|NCT02304432|Secondary|Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)|Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||microvolts squared|||Number
1319825|NCT02304432|Secondary|Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)|Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz.|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||microvolts|||Number
1319826|NCT02304432|Secondary|Auditory Evoked Potentials in Latency (Msec)|Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz.|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||msec|||Number
1319827|NCT02304432|Secondary|Brain Glycine/CR Ratio|Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex.|Baseline and Week 8 of DCS treatment|Data collected only during only one of the open label periods for financial and logistical reasons. Data were collected in week 8 of the first open-label DCS exposure in one subject and in week 8 of the second open-label DCS exposure in the other subject for logistical reasons.|||ratio||Full Range|Median
1319828|NCT02304432|Secondary|Neurocognitive Function|Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution, standard deviation of 10. Higher scores signify better functioning.|Baseline and Week 8 of open-label DCS treatment|The on DCS data were collected during week 8 of the first open-label portion of the study in one subject and in week 8 of the second open-label portion of the study in the other subject for logistical reasons.|||T scores||Full Range|Median
1319829|NCT02304432|Primary|Depression Symptom Scores|Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
1319830|NCT02304432|Primary|Mania Symptom Scores|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
1319831|NCT02304432|Primary|Depression Symptom Scores|Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
1319832|NCT02304432|Primary|Mania Symptom Scores|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
1319833|NCT02304432|Primary|Clinical Global Impression (CGI) Severity Scores|CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
1319834|NCT02304432|Primary|Clinical Global Impression (CGI) Severity Scores|CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
1319835|NCT02304432|Primary|Brief Psychiatric Rating Scale (BPRS) Scores|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
1319836|NCT02304432|Primary|Brief Psychiatric Rating Scale (BPRS) Scores|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
1319837|NCT02304432|Primary|Positive and Negative Symptom Scores|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
1319838|NCT02304432|Primary|Positive and Negative Symptom Scores|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
1319839|NCT02303743|Secondary|Patient Satisfaction Were Assessed With a Specific Questionnaire|Patient satisfaction were assessed with a specific questionnaire before colonoscopy. Patients were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers. The items read as follows: (1) “Do you have experience with a previous colonoscopy?”; (2) “Have you used the phone application?”; (3) “How easy was the preparation for colonoscopy?”; (4) “Which is your level of satisfaction with the bowel preparation?”; (5) “Would you like to repeat the same preparation in the future?”; (6) “Did you have any difficulty with the preparation?”. Patient responses to the questionnaire were categorical (yes or no; questions 1, 2, 5, and 6) or numerical scale answers (0 to 10), from very difficult or very bad (0 or close to 0) to very easy or very good (10 or close to 10) (items 3 and 4).|Day 1||||units on a scale||Standard Deviation|Mean
1319840|NCT02303743|Primary|Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure|The quality of bowel cleansing is evaluated after colonoscopy (Day 1). Baseline the patients initiated low fiber diet in the 24 hours prior to colonoscopy. The HCS uses a 5-point qualitative scale in 5 separate colon segments. HCS is the sum of 5 segments, ranging from 0 (worst possible outcome) to 20 (best possible outcome). Global score assesses the quality of bowel cleansing: Successful (A or B) / unsuccessful (C or D). A: All segments scored 3 or 4; B: One or more segments scored 2; C: One or more segments scored 1; and D: One or more segments scored 0.|Day 1||||units on a scale||Standard Deviation|Mean
1319841|NCT02303704|Secondary|Operative Mortality|Deaths due to surgical complication during or after surgery.|Within 30 days after surgical Procedure|all patients who underwent surgery and monitored for death due to surgical complication.|||participants|||Number
1319842|NCT02303704|Secondary|Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support|The need of IABPC (mechanical support) before surgery or during weaning from Cardiopulmonary bypass and in ICU to assist in maintaining hemodynamics of the patient.|24 hours before surgery and upto 1 week of surgical procedure.|All patients who underwent surgery and for whom IABP support was required.|||participants|||Number
1319843|NCT02303704|Secondary|Pharamacological Inotropic Support (Dobutamine)|The Need, Dose and duration of Dobutamine to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Dobutamine was used to wean off the patients from Cardiopulmonary Bypass.|||ug/kg/min||Standard Deviation|Mean
1319844|NCT02303704|Secondary|Pharmacological Inotropic Support (Nor-adrenaline)|The need, dose and duration of Nor-adrenaline infusion to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Nor-adrenaline was used to wean off the patients from Cardiopulmonary Bypass.|||ug/kg/min||Standard Deviation|Mean
1319845|NCT02303704|Secondary|Pharmacologic Inotropic Support (Adrenaline)|The need, dose and duration of adrenaline infusion to maintain hemodynamic stability after surgery were noted.|Upto 1 week after sugery|All patients in whom Adrenaline was used to wean off the patients from Cardiopulmonary Bypass.|||ug/kg/min||Standard Deviation|Mean
1319846|NCT02303704|Primary|Post-op CK-MB Levels|CK-MB is a marker of Myocardial Damage.|36 hours after surgery.|All patients in whom Peak CKMB levels were noted within 24 hours after surgery|||IU/L||Standard Deviation|Mean
1319847|NCT02302807|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale|The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.|Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)||||Participants||Standard Deviation|Mean
1319848|NCT02302807|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale|The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.|Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)||||Participants||Standard Deviation|Mean
1319849|NCT02302807|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale|The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.|Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)||||Participants||Standard Deviation|Mean
1319850|NCT02302807|Secondary|Maximum Observed Serum Atezolizumab Concentration (Cmax)|Cmax was measured for all participants that received at least one dose of Atezolizumab.|30 minutes post dose on Day 1 of Cycles 1||||mcg/mL||Standard Deviation|Geometric Mean
1319851|NCT02302807|Secondary|Percentage of Participants With Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)|ORR was defined as the percentage of participants, who had an objective response. Objective response was defined as either a complete response (CR) or partial response (PR) as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Objective response in this study did not need to be a confirmed response. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. ORR=CR+PR|Up to approximately 25 months after first participant enrolled||||Percentage of participants||95% Confidence Interval|Number
1319852|NCT02302807|Secondary|Minimum Observed Serum Atezolizumab Concentration (Cmin)|Cmin was measured for all participants that received at least one dose of Atezolizumab.|Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)|The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.|||mcg/mL||Standard Deviation|Geometric Mean
1319853|NCT02302807|Secondary|Percentage of Participants With Anti-therapeutic Antibodies (ATA) to Atezolizumab|Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was >/= 0.60 titer units at any time after initial drug initiation.|Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)|ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result.|||percentage of participants|||Number
1319854|NCT02302807|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to approximately 25 months after first participant enrolled|Safety analyses was performed on all randomized patients who received any amount of study treatment, with patients grouped according to whether any amount of atezolizumab was received including the case when atezolizumab was received in error.|||percentage|||Number
1319855|NCT02302807|Secondary|Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1|DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.|Up to approximately 25 months after first participant enrolled|DOR analyses was performed on the subset of patients who achieved an objective response.|||months||95% Confidence Interval|Median
1319856|NCT02302807|Secondary|Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1|PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of >/= 5 millimeters (mm).|Up to approximately 25 months after first participant enrolled|Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.|||months||95% Confidence Interval|Median
1319857|NCT02302807|Primary|Overall Survival (OS)|OS was defined as time from randomization to death from any cause.|Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled|Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.|||Months||95% Confidence Interval|Median
1319858|NCT02302716|Secondary|Percentage of Participants With Hypoglycemic Events|The percentage of participants (with at least 1 hypoglycemic event (total, severe, nocturnal, and others) or incidence during the study was analyzed using Fisher's exact test. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Endpoint [up to 24 weeks]|All randomized participants who had a post-baseline measurement for Hypoglycemic Events; last observation carried forward (LOCF).|||Percentage of participants|||Number
1319859|NCT02302716|Secondary|Rate of Hypoglycemic Events Adjusted Per 1 Year|The rate of hypoglycemic events were analyzed at baseline, titration, maintenance, and overall study periods and at endpoint using the Wilcoxon test. In addition, a negative binomial model was used as a sensitivity analysis. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Baseline through Endpoint [up to 24 weeks]|All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event; last observation carried forward (LOCF).|||Hypoglycemic events per 1 year||Standard Deviation|Mean
1319860|NCT02302716|Secondary|Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®|The percentage of participants with detected insulin antibodies were summarized as counts and percentages at baseline, at each visit, at the 24-week endpoint (LOCF), and overall for the 24-week treatment period.|Endpoint [up to 24 weeks]|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline with detectable anti-drug antibodies; last observation carried forward (LOCF).|||Percentage of participants|||Number
1319861|NCT02302716|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. LS means was determined by MMRM with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 4 and Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure.|||units on a scale||Standard Error|Least Squares Mean
1319862|NCT02302716|Secondary|Change From Baseline to 24 Weeks in Body Weight|Change from baseline in body weight. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Baseline, 24 Weeks|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure.|||Kilogram (kg)||Standard Error|Least Squares Mean
1319878|NCT02302365|Other Pre-specified|Pre-procedure WBC Count|Pre-procedure WBC count|Prior to Each Spectra Optia Apheresis Procedure|The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected.|||cells x 10^9/L|procedures|Standard Deviation|Mean
1319957|NCT02299869|Primary|Cosmetic Appearance Preference|Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference|20 minutes||||participants|||Number
1319863|NCT02302716|Secondary|Basal Insulin Dose Per Body Weight (U/kg/Day)|Basal Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose per Body Weight measure.|||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
1319864|NCT02302716|Secondary|Basal Insulin Dose Units Per Day|Units of Basal Insulin dose taken per day (U/day). Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose.|||Units per day (U/day)||Standard Error|Least Squares Mean
1319865|NCT02302716|Secondary|Intra-Participant Variability in Fasting Blood Glucose (FBG)|Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Intra-Participant FBG variability was calculated based on the standard deviation (SD) of the morning pre-meal BG value. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure.|||mmol/L||Standard Error|Least Squares Mean
1319866|NCT02302716|Secondary|Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values|Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Baseline, Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1319867|NCT02302716|Secondary|Percentage of Participants With HbA1c <7% and ≤6.5%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.|Endpoint [up to 24 weeks]|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).|||Percentage of participants|||Number
1319868|NCT02302716|Primary|Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)|"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit*treatment in the model."|Baseline, 24 weeks|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1319869|NCT02302365|Other Pre-specified|Waste Bag Volume|Volume of the depletion product|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets; One patient terminated the first procedure prematurely, resulting in a total of 57 units analyzed.|||mL|procedures|Standard Deviation|Mean
1319870|NCT02302365|Other Pre-specified|Platelet Change (% Change)|% change in patient's pre and post-depletion procedure platelet counts|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.|||percent change|procedures|Standard Deviation|Mean
1319871|NCT02302365|Other Pre-specified|Procedure Duration|The duration of the WBCD procedure measured in minutes|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets|||minutes|procedures|Standard Deviation|Mean
1319872|NCT02302365|Other Pre-specified|Whole Blood Flow mL/Min|Whole Blood Flow in mL/min measured during the white blood cell depletion procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Set|||mL/min|procedures|Standard Deviation|Mean
1319873|NCT02302365|Post-Hoc|Total Blood Volumes (TBV) Processed|Number of times the patient's TBV was processed during the apheresis procedure based on the patient's estimated TBV (Estimated by Nadler's formula for total blood volume of a human being based on gender, height, and weight).|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets|||TBV|procedures|Standard Deviation|Mean
1319874|NCT02302365|Other Pre-specified|Whole Blood Processed (mL)|Volume of patient's blood processed in mL during the apheresis procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets|||mL|procedures|Standard Deviation|Mean
1319875|NCT02302365|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure|Patient's platelet count post-depletion procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.|||cells x 10^3/L|procedures|Standard Deviation|Mean
1319876|NCT02302365|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure|Patient's platelet count pre-depletion procedure|Prior to Each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets.|||cells x 10^3/L|procedures|Standard Deviation|Mean
1319877|NCT02302365|Other Pre-specified|Post-procedure WBC Count|Post-procedure WBC count|Following apheresis procedure|Data were collected on a total of 58 procedures, however one patient terminated the first procedure prematurely and therefore did not have post-procedure data.|||cells x 10^9/L|procedure|Standard Deviation|Mean
1320514|NCT02288273|Secondary|Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient||Day 64/65||||mg/dL||Standard Error|Least Squares Mean
1319879|NCT02302365|Primary|Adverse Events|Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.|Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.|Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, < 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%).|||Number of subjects with at least 1 TEAE|||Number
1319880|NCT02302365|Primary|Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.|Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)|immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure|The CE of the WBCD procedures was measured from the waste bag (depletion product) contents from Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1.|||percent of processed WBCs|procedures|Standard Deviation|Mean
1319881|NCT02302365|Primary|Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure|Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%|immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure|The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected. One patient terminated the first procedure prematurely and therefore did not have post-procedure data, resulting in a total of 57 units analyzed.|||% change in subject's WBC count|procedures|Standard Deviation|Mean
1319882|NCT02302092|Secondary|Number of Participants With Clinically Significant Change in Physical Examination Findings|Physical examination consists of examinations of the following body systems: (1) cardiovascular system; (2) dermatologic system (3) ears, nose, throat; (4) extremities; (5) eyes; (6) gastrointestinal system; (7) genitourinary system; (8) lymph nodes; (9) musculoskeletal system; (10) nervous system; (11) respiratory system.|Day 1 up to Day 21|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
1319883|NCT02302092|Secondary|Number of Participants With Clinically Significant Change in Vital Signs|Vital signs included body temperature (axillary measurement), diastolic and systolic blood pressure (5 minutes), respiratory rate, and pulse (bpm).|Day 1 up to Day 21|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
1319884|NCT02302092|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Values|The number of participants with any markedly abnormal (above or below normal ranges) standard safety laboratory values was collected throughout study.|Day 21|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
1319885|NCT02302092|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment-Emergent-Adverse Events (TEAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Baseline up to Day 30|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
1319886|NCT02302092|Secondary|Percentage of Participants With a Superinfection at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. A superinfection was defined as growth of a uropathogen other than the original pathogen at a level greater than or equal to 10^4 CFU/mL at any time during the course of active therapy.|Baseline, Day 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for superinfection due to particular pathogen numbers in different time periods was not determined.||||||
1319887|NCT02302092|Secondary|Percentage of Participants With a New Infection at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. A new infection was defined as the isolation and growth of a uropathogen other than the original pathogen.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for new infection due to particular pathogen numbers in different time periods was not determined.||||||
1319888|NCT02302092|Secondary|Percentage of Participants With Microbiologic Persistence of the Unique Pathogen at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample was processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. Microbiological response at the TOC visit was be based on the same grades as for the EOT visit. The infection was considered to be persistent if the level of the uropathogen has increased by greater than or equal to 10^4 CFU/mL from the time of study entry to that of the EOT and TOC visits.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for persistence of particular pathogen numbers in different time periods was not determined.||||||
1319911|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)|Response of the participants to the treatment burden domain of the CFQ-R at the end of 3 months|3 months||||units on a scale||Standard Deviation|Mean
1319889|NCT02302092|Secondary|Percentage of Participants With Microbiologic Eradication of the Unique Pathogen at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Day 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. Microbiological response at the TOC visit was based on the same grades as for the EOT visit. The infection was considered to be eradicated if all uropathogens isolated at study entry at a level equal to or greater than 10^4 CFU/mL have decreased to less than 10^4 CFU/mL.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for eradication for particular pathogen numbers in different time periods was not determined.||||||
1319890|NCT02302092|Secondary|Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits|At Visit 3 (Day 3) and at the TOC (Days 14 to 21) and LFU visits (Day 30), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline.|Baseline, Days 3, 14 to 21 and 30|The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.|||percentage of participants|||Number
1319891|NCT02302092|Secondary|Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits|A urine sample was collected at EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine level of uropathogen. Cultures of urine sample were processed by calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 colony forming units per milliliter (CFU/mL). Microbiological success was defined as bacterial uropathogen level of <10^4 CFU/mL. Microbiological response was categorized as:microbiological eradication/persistence/new infection/superinfection. An infection was eradicated if all uropathogens isolated at study entry at a level ≥10^4 CFU/mL have decreased to <10^4 CFU/mL, persistent if level of uropathogen has increased by ≥10^4 CFU/Ml. A new infection, if there is isolation and growth of a uropathogen other than original pathogen and superinfection if there is growth of a uropathogen other than original pathogen at a level ≥10^4 CFU/mL. Microbiological success was assessed relative to baseline.|Baseline, Days 7 to 14 and 14 to 21|The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.|||percentage of participants|||Number
1319892|NCT02302092|Primary|Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit|At the EOT visit (Days 7 to 14), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline.|Baseline and Days 7 to 14|The micro-intent to treat (ITT) population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.|||percentage of participants|||Number
1319893|NCT02301975|Secondary|Change From Baseline in PM PEF|PEF was measured using an electric flow meter each evening. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||L/min||Standard Error|Least Squares Mean
1319894|NCT02301975|Secondary|Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20|The ACT was a five-item questionnaire developed as a measure of participant’s asthma control. The percentage of participants controlled, defined as having ACT score greater than or equal to 20 at the end of Week 24 were analyzed using logistic regression model with covariates of Baseline ACT score, region, sex, age and treatment group.|Week 24|ITT Population|||Percentage of participants|||Number
1319895|NCT02301975|Secondary|Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF)|PEF was measured using an electric flow meter each morning. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||Liter per minute (L/min)||Standard Error|Least Squares Mean
1319896|NCT02301975|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods|Change from Baseline in the percentage of symptom-free 24 hour period was evaluated. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value.Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||Percentage of symptom-free 24 hour perio||Standard Error|Least Squares Mean
1319909|NCT02301429|Primary|All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.|All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.|1 month|all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis|||Adverse Events|||Number
1319910|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)|Response of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months|3 months||||units on a scale||Standard Deviation|Mean
1319897|NCT02301975|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods|The number of inhalations of rescue medication used during the day and night were recorded by participants using an electronic diary (e-diary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1319898|NCT02301975|Primary|Change From Baseline in PM FEV1 Using Per Protocol (PP) Population|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations.|Baseline and Week 24|PP Population|||L||Standard Error|Least Squares Mean
1319899|NCT02301975|Primary|Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication.|Baseline and Week 24|ITT population|||Liter (L)||Standard Error|Least Squares Mean
1319900|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1319901|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1319902|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1319903|NCT02301936|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
1319904|NCT02301936|Secondary|HCV RNA Change From Baseline||Up to 24 weeks|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1319905|NCT02301936|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 1, 2, 4, 8,12, 16, 20, and 24|Full Analysis Set|||percentage of participants|||Number
1319906|NCT02301936|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug.|Posttreatment Week 4|Full Analysis Set|||percentage of participants|||Number
1319907|NCT02301936|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1319908|NCT02301936|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who took at least 1 dose of study drug|||percentage of participants|||Number
1319912|NCT02301377|Primary|Medication Adherence|Overall adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins based on prescription refill data. The actual number of prescriptions of each of the three medications filled in the 3-month period was divided by the number that should have been filled based on the prescribed amount of each medication and that value was multiplied by a 100 to generate a percentage.|3 months||||Percent Adherence||Standard Deviation|Mean
1319913|NCT02301364|Secondary|Overall Response Rate|This study will use the Macdonald criteria. Specific lesions must be evaluated serially, and comparative analysis of changes in the area of contrast enhancement, as well as the non-enhancing component, should be performed. Complete Response: Complete disappearance of all measurable and non-measurable disease. No new lesions. Partial Response: Great than or equal to 50% decrease over the baseline in the sum of products of perpendicular diameters of all measurable lesions. no progression of non-measurable disease. No new lesions. Stable/No Response: Does not qualify for CT, PR, or progression. Progressive Disease: 25% increase in the sum of products of all measureable lesions over smallest sum observes (or baseline if no decrease), OR clear clinical worsening of any non-measurable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|2 years||||Participants|||Count of Participants
1319914|NCT02301364|Secondary|Overall Survival|Overall survival time is defined as the time from treatment start to the date of death due to any cause.|2 years||||days||Full Range|Median
1319915|NCT02301364|Secondary|Number of Participants With Adverse Events|Adverse events be summarized based on the Common Toxicity Criteria version 4.0.|2 years||||Participants|||Count of Participants
1319916|NCT02301364|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the time from the date of treatment start to the date of the first documented PD or death due to any cause. PFS will be based on the investigator’s assessment of MRI, CSF studies and clinical presentation.|2 years||||days||Full Range|Median
1319917|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).|"Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.~Lower values represent a better outcome"|Time zero equals baseline (Day 1) up to Day 28||||units on a scale||Standard Deviation|Mean
1319918|NCT02301169|Secondary|Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period|11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.|Time zero equals baseline (Day 1) up to Day 28||||units on a scale||Standard Deviation|Mean
1319919|NCT02301169|Secondary|Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)|IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.|Time zero equals baseline (Day 1) up to Day 28||||units on a scale||Standard Deviation|Mean
1319920|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)|11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42||||units on a scale||Standard Deviation|Mean
1319921|NCT02301169|Primary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment|11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42||||units on a scale||Standard Deviation|Mean
1319922|NCT02300558|Secondary|Change From Baseline in Mean Nocturnal QTcF Interval to Week 24 (Lead V5; Holter)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM."|Baseline; Week 24|Participants in the the Full Analysis Set with available data were analyzed.|||msec||95% Confidence Interval|Mean
1319923|NCT02300558|Secondary|Change From Baseline in Mean Daily (Daytime and Nocturnal) QTcF Interval to Week 24 (Lead V5; Holter)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from predose to 6 hours postdose. Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM. Daily was computed as the average of daytime (AUC0-6/6) and nocturnal (AUC0-6/6), with both values required to compute the average."|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||msec||95% Confidence Interval|Mean
1319924|NCT02300558|Secondary|Change From Baseline in Mean Daytime QTcF Interval (AUC0-6/6) to Week 12 (Lead V5; Standard 12-lead ECG)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times) .~Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point."|Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||msec||95% Confidence Interval|Mean
1319925|NCT02300558|Primary|Change From Baseline in Mean Daytime QT Interval in Lead V5 Corrected for Heart Rate Using the Fridericia Formula (QTcF) Interval to Week 24 (Based on Standard 12-lead ECG Data)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times).~Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point."|Baseline; Week 24|Participants in Full Analysis Set (FAS) with available data were analyzed. FAS was defined as all enrolled participants who have confirmed LQT3 genotype, do not have confirmed LQT1 or LQT2 mutations, received at least 1 dose of active eleclazine, and have both a baseline and at least 1 postbaseline mean daytime QTcF interval (standard 12-lead).|||msec||Standard Deviation|Mean
1319926|NCT02300311|Secondary|Patient's Assessment of the Efficacy on the Last Individual Treatment Day|Patients were asked to rate the effect of the study medication for relieving their low back pain using a 4-point verbal rating scale (1=Poor, 2= Fair, 3=Good, 4=Very Good).|1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||percentage of participants|||Number
1319927|NCT02300311|Secondary|Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day|"Difference of average pain intensity from pre-dose baseline on the last individual treatment day (The last individual treatment day was the last day on which the patient had recorded the study drug applications within the patient diary). Pain intensity was assessed by the patient using 0-10 numerical rating scale (NRS).~Patients were given two 0-10 numerical rating scales (NRS) - to self-report of pain intensity at given time points for the period 0-8 hours post first dose and to self-report of average pain intensity they had at each treatment day. The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’. APIDtime point = APItime point - PI baseline (time point is the last individual treatment day (either Day 1, 2, 3 or 4 after drug administration)).~Means reported are the adjusted means."|Baseline and 1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||points on a scale||Standard Error|Mean
1319928|NCT02300311|Secondary|Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after trial medication application. The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’. PID4h= PI(4h) - PI(baseline). Means reported are the adjusted means.|Baseline and 4 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||points on a scale||Standard Error|Mean
1319929|NCT02300311|Primary|Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)|"Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after trial medication application.~The left side of each scale (0) is marked ‘no pain’ and the right side of the scale (10) is marked ‘worst pain possible’.~PID8h= Pain intensity (PI)8h - PI(baseline).~Means reported are the adjusted means."|Baseline and 8 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||points on a scale||Standard Error|Mean
1319930|NCT02300298|Secondary|AUC0-infinity of Docetaxel|This outcome measure presents the AUC0-infinity of docetaxel in plasma in cycles 1 and 2.|just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319931|NCT02300298|Secondary|Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|This outcome measure presents the Area under the concentration-time curve of nintedanib over the time interval from 0 extrapolated to infinity in plasma (AUC0-infinity) in cycle 1.|at 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319932|NCT02300298|Secondary|AUC0-tz of Docetaxel|This outcome measure presents AUC0-tz of docetaxel in plasma in cycles 1 and 2.|just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319933|NCT02300298|Secondary|Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 to Time of the Last Quantifiable Concentration (AUC0-tz)|This outcome measure presents the area under the concentration-time curve of nintedanib over the time interval from 0 to time of the last quantifiable concentration in plasma (AUC0-tz) in cycle 1.|at 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34and 47:55 after first drug administration of docetaxel in cycle 1.|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1319934|NCT02300298|Secondary|Cmax of Docetaxel|This outcome measure presents the Cmax of docetaxel in plasma in cycles 1 and 2.|just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)|PKS|||nanogram (ng)/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1319935|NCT02300298|Secondary|Maximum Measured Concentration (Cmax) of Nintedanib|This outcome measure presents the maximum measured concentration (Cmax) of nintedanib in plasma in cycle 1.|at 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.|Pharmacokinetic set (PKS) included all patients in treated set who had at least one valid drug plasma concentration available. This patient set was used for the analysis of pharmacokinetics.|||nanogram (ng)/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1319951|NCT02300025|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population.|||hrs||Full Range|Median
1319952|NCT02300025|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|Pharmacokinetic (PK) population included all participants who received at least one dose of cobimetinib and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1319953|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|20 minutes||||participants|||Number
1319936|NCT02300298|Primary|Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1|"DLT was defined as any of the following study drug related adverse events (AEs):~Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 non-haematological toxicity except transient electrolyte abnormality and isolated increase of gamma-glutamyltransferase (GGT); gastrointestinal toxicity, despite adequate supportive care~CTCAE grade 4 haematological toxicity; Neutrophil count decreased or white blood cell count (not associated with fever) for >7 days despite adequate supportive treatment~CTCAE grade 4 febrile neutropenia with fever ≥38.5 degrees~CTCAE grade ≥2 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase in conjunction with CTCAE grade ≥2 total bilirubin increase~Inability to resume nintedanib dosing within 14 days after stopping Investigators judged clinically as DLT after dose reduction and severity medically notable (CTCAE, version 3). Sponsor with safety review committee was allowed to confirm the adequacy of this judgment."|Cycle 1, from first administration of study medication up to 21 days thereafter.|Treated set 2 included all patients who were dispensed study medication and were documented to have taken at least one dose of study treatment, except replaced patients according to the trial clinical protocol.|||participants|||Number
1319937|NCT02300129|Primary|Total Number of Flushes for Each 2-week Period||Day 22 and Day 36/Early termination|Per protocol population of Period 2, N= 31|||Flushes count||Standard Deviation|Mean
1319938|NCT02300103|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1319939|NCT02300103|Secondary|HCV RNA Change From Baseline||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1319940|NCT02300103|Secondary|Percentage of Participants With HCV RNA < LLOQ On-treatment||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1319941|NCT02300103|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1319942|NCT02300103|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1319943|NCT02300103|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1319944|NCT02300025|Primary|Apparent Volume of Distribution (Vz/F)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F after the oral dose is influenced by the fraction absorbed.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||Liter||Standard Deviation|Mean
1319945|NCT02300025|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||Liter per hr (L/hr)||Standard Deviation|Mean
1319946|NCT02300025|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration of cobimetinib to decrease by one half.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||hr||Standard Deviation|Mean
1319947|NCT02300025|Primary|Apparent Terminal Elimination Rate Constant (λZ)|λZ was defined as the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||1 per hr (1/hr)||Standard Deviation|Mean
1319948|NCT02300025|Primary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC% extrapolated was defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as [AUC (0-∞) minus AUC(0-t]*100/ AUC (0-∞), where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-t) is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||% extrapolated||Standard Deviation|Mean
1319949|NCT02300025|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) was defined as AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t- ∞).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||ng*hr/mL||Standard Deviation|Mean
1319950|NCT02300025|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t) was defined as area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK Population.|||ng*hr/mL||Standard Deviation|Mean
1319958|NCT02299791|Primary|Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both|Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin.|Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months|clinic patients with diabetes who had a clinic encounter (in person or by telephone) within the previous year and were indicated for ACE/ARB and statin per current national care guidelines|||Participants|||Count of Participants
1319959|NCT02299635|Secondary|Number of Notch Genomic Alterations in Participants With NA+ mTNBC|Number of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
1319960|NCT02299635|Secondary|Number of Participants With Laboratory Test (Urinalysis) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 urinalysis test abnormalities for urine protein.|Day 1 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1319961|NCT02299635|Secondary|Number of Participants With Laboratory Test (Chemistry) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 chemistry test abnormalities|Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1319962|NCT02299635|Secondary|Number of Participants With Laboratory Test (Hematology) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 hematological test abnormalities.|Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles.|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1319963|NCT02299635|Secondary|Number of Participants With Treatment-Emergent AEs by CTCAE Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AEs were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1319964|NCT02299635|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as all deaths, regardless of cause, from treatment start until 28 days after the last dose and non-fatal events occurring after treatment start regardless of cause, up until 28 days after the last dose or until start of new anti-cancer treatment, whichever was first.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
1319965|NCT02299635|Secondary|Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood.|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.||||||
1319966|NCT02299635|Secondary|Pharmacodynamic (PD) Effects of PF‑03084014 in Tumor Specimens and Peripheral Blood|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.||||||
1319967|NCT02299635|Secondary|Pre-dose Serum Concentration (Ctrough) for PF-03084014||Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PK analyses were performed for this study.||||||
1319968|NCT02299635|Secondary|Type of Notch Genomic Alterations in Participants With NA+ mTNBC|Type of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
1319969|NCT02299635|Secondary|Overall Survival (OS) in Participants With NA+ or NA mTNBC|OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
1319970|NCT02299635|Secondary|One-Year Survival Probability in Participants With NA+ or NA mTNBC|Overall survival (OS) status (alive or not) at 1 year after study entry. The the survival probability at 1 year was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events.|1 year|Data for this outcome measure was not collected due to early termination of this study.||||||
1319971|NCT02299635|Secondary|Duration of Response (DR) in Participants With NA+ or NA mTNBC|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
1319972|NCT02299635|Secondary|Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC|The period from study entry until disease progression, death, whichever occurred first as per RECIST version 1.1.|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
1320053|NCT02298842|Secondary|Percent of Platelets Activated as Measured by P-selectin|Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||Percent of Platelets Activated||Standard Deviation|Mean
1319973|NCT02299635|Secondary|OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)|OR status based on assessment of confirmed CR or confirmed PR according to RECIST 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis <10 mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.||||||
1319974|NCT02299635|Primary|Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+)|OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than [<]10 millimeter [mm]). PR: Greater than or equal to (>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.||||||
1319975|NCT02299570|Secondary|Number of Subjects With Serious Adverse Events Through 24 Months|The number of subjects in each treatment group with serious adverse events will be calculated through 24 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.|24 months after last treatment with RBX2660|||||||
1319976|NCT02299570|Secondary|Number of Subjects With Adverse Events Through 12 Months|The number of subjects in each treatment group with adverse events will be calculated through 12 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.|12 months|||||||
1319977|NCT02299570|Primary|Efficacy of Active Treatment Compared to Placebo at Measured at 8 Weeks Post-treatment|The absence of C. difficile diarrhea without the need for retreatment at 56 days after administration of the last assigned study enema, will be compared between the number of subjects who receive two enemas of RBX2660 to the number of subjects who receive two enemas of placebo.|8 weeks after last assigned study treatment||||Participants|||Count of Participants
1319978|NCT02299427|Primary|Simulated Behavior With Dogs on Standardized Objective Scale|Coded behavior in dollhouse simulation. Specifically, in 7 simulated scenarios using a dollhouse that included child and dog characters, furniture, yard, etc., children heard a scene and explained/used the dolls to act what would happen next. For example, the experimenter acted a child doll playing in the kitchen near dog food and the doll dog entered, saw the child, and approached the food bowl. The experimenter said, “[Child’s Name] is playing around in the kitchen near [Dog name’s] food. [Dog’s name] comes into the kitchen and sees [Child’s Name] near his/her food bowl making him/her upset and start to growl. What will happen next?” The task was coded using objective coding criteria to score the child’s response as safe (1 point), safe but not optimal (0.5 points), or unsafe (0 points). Scores across the 7 scenarios were summed to yield a single score; possible range = 0=7. Higher scores indicate better safety. Inter-rater reliability on 30% of the sample was good; kappa = .90.|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure|||units on a scale||Standard Deviation|Mean
1319979|NCT02299427|Primary|Children's Behavior With Dogs on Standardized Objective Scale|Coded behavior using objective criteria during a semi-structured interaction with a live therapy dog. Specifically, we examined behavioral patterns for 15 tasks/activities/decisions the child made with the live dog. Sample tasks were when and how the child touched the dog, the extent to which the child was close or intimate to the dog, whether the child handled the dog’s toys, and whether the child interrupted the dog during its “rest time”. 7 of those hung together in factor analysis. Those 7 were standardized and then averaged to create the scale. It was transformed with linear transformation so all values are positive. Higher numbers indicate higher risk-taking. Theoretically the scale is 0-infinity; in practice most children scored between 0-4. The individual items had an average intercorrelation of .50 and Cronbach's alpha of .65.|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure|||units on a scale||Standard Deviation|Mean
1319980|NCT02299375|Secondary|Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate mean corpuscle volume. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Femtoliters||Standard Deviation|Mean
1319981|NCT02299375|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate mean corpuscle hemoglobin. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Picograms||Standard Deviation|Mean
1319990|NCT02299375|Secondary|Number of Participants With Abnormal Liver Events During the Treatment Period|Various liver chemistry parameters were monitored periodically to ensure the safety and tolerability of Losmapimod as compared to placebo. Study treatments were discontinued for par. if alanine aminotransferase (ALT) absolute >= 5xupper limit of normal (ULN) or; ALT >= 3xULN persists for >=4 Weeks or; ALT>=3x ULN and bilirubin >=2xULN or; ALT>=3x ULN and International normalized ratio (INR) >=1.5 or; ALT>=3x ULN and cannot be monitored weekly for 4 Weeks or; ALT>=3x ULN symptomatic.|Up to Week 53|mITT Population|||Participants|||Number
1319982|NCT02299375|Secondary|Change From Baseline in Red Blood Cell Count at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate Red blood cell count. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Trillion cells per liter (TI/L)||Standard Deviation|Mean
1319983|NCT02299375|Secondary|Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate calcium, chloride, glucose, potassium, sodium and blood urea nitrogenat the indicated time point. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Millimole (MMOL)/L||Standard Deviation|Mean
1319984|NCT02299375|Secondary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma glutamyl transferase at the indicated time point. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||International units (IU)/ L||Standard Deviation|Mean
1319985|NCT02299375|Secondary|Change From Baseline in Total Bilirubin, Direct Bilirubin, Uric Acid and Creatinine at the Indicated Time Point|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate total bilirubin, direct bilirubin, urice acid and creatinine. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Micromole (UMOL)/ L||Standard Deviation|Mean
1319986|NCT02299375|Secondary|Change From Baseline in Eosinophil Percentage at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate eosinophil percentage. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Percent change||Standard Deviation|Mean
1319987|NCT02299375|Secondary|Change From Baseline in Absolute White Blood Cell (WBC) Count, Total Neutrophil, Total Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Point|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate absolute WBC count, total neutrophil, total lymphocyte, basophil, absolute eosinophil, percentage eosinophil, monocyte and platelet count. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Giga cells per liter (G/L)||Standard Deviation|Mean
1319988|NCT02299375|Secondary|Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate hematocrit. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||L||Standard Deviation|Mean
1319989|NCT02299375|Secondary|Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate hemoglobin, total protein, albumin and MCHC. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Gram (G)/Liter (L)||Standard Deviation|Mean
1320540|NCT02287623|Secondary|Post Operative Opioid Use|Post operative opioid use from 0-24 hours after surgery.|0-24 hours||||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
1319991|NCT02299375|Secondary|Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total, SGRQ Symptoms Score, SGRQ Activity Score and SGRQ Impact Score Over Time|SGRQ-C is a health related quality of life questionnaire consisting of 14 questions. SGRQ-C total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. Components (Activity, Symptoms, Impacts) were calculated as 100 multiplied by summed weights from all positive items in that component divided by sum of weights for all items in that component. Score range for SGRQ-C total is 0-100. Maximum weights for Activity, Symptoms and Impacts component is 982.9, 566.2 and 1652.8 respectively. SGRQ-C was transformed to SGRQ for reporting. Higher scores indicate greater disease impact. Score at Day 1, pre-dose (Week 0) was considered as Baseline. Change from Baseline was calculated as score at indicated time point minus Baseline value. Only those par. with analyzable data at the given time points (represented by n=X, X in category titles) were included in analysis.|Baseline and up to Week 52|mITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1319992|NCT02299375|Secondary|Change From Baseline in Frequency of Short Acting Beta-agonist or Anti-cholinergic Use|Use of short acting bronchodilators (short-acting beta2-agonists or short-acting anti-cholinergic) was allowed and was recorded in daily patient diary. It included inhaled short-acting beta2-agonists (e.g. Ipratropium bromide, salbutamol, Ipratropium/salbutamol (albuterol) combination product) and short-acting anti-cholinergics (e.g., ipratropium bromide3). Use of these medications was allowed throughout the study except 4 hours prior to and during each clinic visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 52|mITT Population|||Average number of puffs per 24 hours||Standard Deviation|Mean
1319993|NCT02299375|Secondary|Plasma Losmapimod Maximum Concentration (Cmax) and Lowest Concentration (Ctrough) at Steady State|Pharmacokinetics of losmapimod was evaluated in participants with COPD using PK samples collected at pre-dose at Week 2 and Week 12. At Week 26, a sample was collected at pre-dose and a second sample was collected at 2 hours post-dose. Par. of mITT population that provided at least one observed concentration data in this study were considered for PK analysis (represented by n=X, X in the category titles). Drug plasma concentration-time data were modelled by nonlinear mixed effects modelling to develop a Population PK model. Cmax and Ctrough were estimated from the PK model.|Pre-dose at Weeks 2 and 12; pre-dose and at 2 hours post-dose at Week 26|PK Population.|||ng/ mL||95% Confidence Interval|Geometric Mean
1319994|NCT02299375|Secondary|Plasma Losmapimod Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the End of Dosing Interval (AUC[0-tau])|Pharmacokinetics (PK) of losmapimod was evaluated in participants with COPD using PK samples collected at pre-dose at Week 2 and Week 12. At Week 26, a sample was collected at pre-dose and a second sample was collected at 2 hours post-dose. Par. of mITT population that provided at least one observed concentration data in this study were considered for PK analysis. Drug plasma concentration-time data were modelled by nonlinear mixed effects modelling. AUC[0-tau] (tau=12 hours) was estimated from the model.|Pre-dose at Weeks 2 and 12; pre-dose and at 2 hours post-dose at Week 26|PK Population.|||hour (h)*nanogram (ng)/milliliter (mL)||95% Confidence Interval|Geometric Mean
1319995|NCT02299375|Secondary|Change From Baseline in Heart Rate (HR) Values at the Indicated Time Points|HR was assessed at Screening, Baseline (day 1, pre-dose) and post dose at Weeks 2, 4, 8, 12, 26, 39, 52 and at follow up (Week 53). Measurements were taken in a semi-recumbent position after 5 minutes rest. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the value at day 1, pre-dose. Par. were included in the analysis if they had at least one post-baseline measurement. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Beats per minute (bpm)||Standard Deviation|Mean
1319996|NCT02299375|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP were taken at Screening, Baseline (day 1, pre-dose) and post dose at Weeks 2, 4, 8, 12, 26, 39, 52 and at follow up (Week 53). Measurements were taken in a semi-recumbent position after 5 minutes rest. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the value at day 1, pre-dose. Par. were included in the analysis if they had at least one post-baseline measurement. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1319997|NCT02299375|Secondary|Number of Participants With Electrocardiogram (ECG) Findings|12-lead ECGs were obtained in triplicate at Screening then singly at Baseline (day 1, pre-dose) and post dose at Weeks 2, 4, 8, 12, 26, 39, 52 and at follow up (Week 53) using an ECG machine that automatically calculates the heart rate (HR) and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia’s formula (QTcF) or QT duration corrected for heart rate by Bazett’s formula (QTcB) intervals. Change in ECG findings were categorized as normal and abnormal. Abnormal ECG values could be clinically significant (CS) or not clinically significant (NCS), as determined by the investigator. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to 53 Weeks|mITT Population|||Participants|||Number
1319998|NCT02299375|Secondary|Change From Baseline in Spirometry Parameters in Pre and Post FEV1/FVC, Percent Predicted (PP) FEV1, PP FEV6 and PP FVC|Pre and post FEV1/FVC, PP FEV1, PP FEV6 and PP FVC were assessed at Screening, Day 1 pre-dose and Weeks 2, 4, 8, 12, 18, 26, 39 and 52. Par. were asked to withheld all bronchodilator therapy included ipratropiumn bromide and salbutamol/albuterol for at least 4 hours prior to the prebronchodilator spirometric test. Post-bronchodilator spirometric assessment was performed after inhalation of 400/360 µg of salbutamol/albuterol in 10-15 minutes. Day 1 (pre-dose) values were considered as Baseline values. Change from Baseline was calculated as value at indicated time point minus Baseline value. The maximum value of the 3 replicate assessments were used. Analysis performed using a mixed-effects repeated measures model. The adjusted mean values were summarized per treatment group. Par. were included in the analysis if they had at least one post-baseline measurement. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 52|mITT Population.|||Percentage||Standard Error|Mean
1320066|NCT02298192|Secondary|HbA1c Below 7.0%|Responders to HbA1c below 7% after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.|||participants|||Number
1319999|NCT02299375|Secondary|Change From Baseline in Spirometry Parameters in Pre and Post Forced Expiratory Volume in 1 Second (FEV1); Pre and Post Forced Vital Capacity (FVC); Pre and Post Forced Expiratory Volume in 6 Seconds (FEV6).|Pre and post FEV1, FVC and FEV6 were performed at Screening, Day 1 pre-dose and Weeks 2, 4, 8, 12, 18, 26, 39 and 52. Par. were asked to withheld all bronchodilator therapy included ipratropiumn bromide and salbutamol/albuterol for at least 4 hours prior to prebronchodilator spirometric test. Post-bronchodilator spirometric assessment was performed after inhalation of 400/360 micograms (µg) of salbutamol/albuterol in 10-15 minutes. Day 1 (pre-dose) values were considered as Baseline values. Change from Baseline was calculated as value at the indicated time point minus Baseline value. The maximum value of the 3 replicate assessments were used. Analysis performed using a mixed-effects repeated measures model. The adjusted mean values were summarized per treatment group. Par. were included in the analysis if they had at least one post-baseline measurement. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 52|mITT Population|||Liters||Standard Error|Mean
1320000|NCT02299375|Secondary|Number of Participants Having Any Adverse Events (AEs), Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. AEs were considered as on-treatment If AE onset date is on or after treatment start date & on or before treatment stop date. par. having any AE or SAE were included in analysis.|From the start of the study treatment up to 53 Weeks|mITT Population|||Participants|||Number
1320001|NCT02299375|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|The time to first moderate-severe COPD exacerbation in par. treated with losmapimod compared to placebo treated par. was evaluated. The time to the first on-treatment moderate-severe exacerbation was calculated as exacerbation onset date of first on-treatment exacerbation minus exposure start date plus 1. No statistical analysis was conducted. Data was summarized statistically only.|From the start of the study treatment up to 53 Weeks|mITT Population|||Days||Standard Deviation|Mean
1320002|NCT02299375|Primary|Annual Rate of Moderate and Severe Exacerbations of COPD|An exacerbation of COPD, is defined as the worsening of 2 or more major symptoms (dyspnea, sputum volume, sputum purulence) or the worsening of any 1 major symptom together with any 1 of the minor symptoms (sore throat, cold, fever without other cause, increased cough and wheeze), for at least 2 consecutive days. Moderate-severe exacerbations were defined as use of antibiotics and/or oral steroids and/or hospitalization. Summary only included exacerbations for which a date of resolution or death was provided. Analysis was performed by using Bayesian inference assuming non-informative priors. The mean exacerbation rate was adjusted for treatment group, smoking status, ICS use and region. The adjusted posterior median was summarized per treatment group. The number of exacerbation events per participant was assumed to follow a negative binomial distribution. Modified Intent-to-Treat (mITT) Population comprised of all randomized par. who received at least one dose of study treatment.|From the start of the study treatment up to 53 Weeks|mITT Population|||Exacerbations per participant per year||Standard Deviation|Median
1320003|NCT02299349|Secondary|MS04 Equivalent Consumption|in hospital total MS04 equivalent consumption|1 day following surgery||||mg||Inter-Quartile Range|Median
1320004|NCT02299349|Primary|Pain Scores (Visual Analog Pain Scores)|visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)|1 day following surgery||||units on a scale||Standard Deviation|Mean
1320005|NCT02299336|Secondary|Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Anatomic Outcomes|Mean change in central retinal thickness from baseline to week 52 based on quantification of ischemic areas|Week 52, Week 104||2019-05-31|05/2019||||
1320006|NCT02299336|Secondary|Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Visual Outcomes|Mean change in visual acuity from baseline to week 52 and baseline to week 104 based on quantification of ischemic areas|Week 52, Week 104||2019-05-31|05/2019||||
1320007|NCT02299336|Secondary|Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment|Evaluate the mean change in central retinal thickness before and after first focal laser treatment in patients treated with pro re nata aflibercept.|104 weeks|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||microns||Standard Error|Mean
1320008|NCT02299336|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy|Evaluation of the effect of laser on Early Treatment Diabetic Retinopathy Study best-corrected visual acuity outcomes. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|104 weeks|All participants receiving laser were included in analysis.|||letters||Standard Deviation|Mean
1320009|NCT02299336|Secondary|Number of Subjects That Receive Focal Laser Treatment.|Number of subjects that receive focal laser treatment from baseline to week 52 and from baseline to week 104.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
1320010|NCT02299336|Secondary|Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy|Number of subjects with stable, worsened, or improved diabetic retinopathy through 104 weeks.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
1320089|NCT02297815|Secondary|Experience Side Effects|Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting|14-20 days after ARTI diagnosis|Question was asked in the 14-20 interview so some subjects were lost to follow-up|||Participants|||Count of Participants
1320011|NCT02299336|Secondary|Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104.|Evaluate the number of subjects with no clinically-relevant diabetic macular edema (as defined in the protocol) on spectral domain optical coherence tomography from baseline to week 52 and baseline to week 104 in patients treated with aflibercept.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
1320012|NCT02299336|Secondary|Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104.|Evaluate the mean change in central retinal thickness from baseline to week 52 and baseline to week 104 in patients treated with aflibercept.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Microns||Standard Error|Mean
1320013|NCT02299336|Secondary|Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104|Evaluate the percentage of subjects with a gain or loss in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letters in patients treated with aflibercept from baseline to week 52 and baseline to week 104|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
1320014|NCT02299336|Secondary|Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Past and Future Anti-VEGF Treatment Burden|Mean number of injections in 52 weeks and 104 weeks based on quantification of ischemic areas|Week 52, Week 104 weeks||2019-05-31|05/2019||||
1320015|NCT02299336|Secondary|Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application.|Measure the role of focal laser treatment (fluorescein angiography-guided, if applicable) in decreasing the treatment burden among subjects who require ongoing aflibercept treatment in the management of diabetic macular edema.|Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks|Only participants who were eligible for focal laser treatment were analyzed.|||Injections||Standard Deviation|Mean
1320016|NCT02299336|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104|Evaluate the mean change over time in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity at week 52 from baseline and at week 104 from baseline. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||letters||Standard Error|Mean
1320017|NCT02299336|Primary|Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial|Measured by evaluating mean number of injections required for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial|Week 104||||injections||Standard Error|Mean
1320018|NCT02299258|Secondary|Adverse Events|bleeding, abdominal pain|up to 5 years||||participants|||Number
1320019|NCT02299258|Primary|Efficiency of Stents|number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study|up to 5 years||||participants|||Number
1320020|NCT02299206|Secondary|Parent/Caregiver Rating of Satisfaction With Use of the Product|Parents/caregivers will be given a questionnaire rating the use of the study products.|14 days|Study was terminated prior to analysis due to low enrollment.||||||
1320021|NCT02299206|Secondary|Assessment of Tolerability by the Infant|Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby’s diaper dermatitis, a VAS severity assessment of their baby’s diaper dermatitis, and observations related to product use and the baby’s comfort level|14 days|Study was terminated prior to analysis due to low enrollment.||||||
1320022|NCT02299206|Secondary|Parents/Caregivers Daily Scores Through Duration of the Study Period|Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby’s diaper dermatitis, a Visual Analogue Scale severity assessment of their baby’s diaper dermatitis, and observations related to product use and the baby’s comfort level|14 days|Study was terminated prior to analysis due to low enrollment.||||||
1320023|NCT02299206|Secondary|Change in Physician Assessment Diaper Dermatitis Scores to Day 7|For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.|7 days|Study was terminated prior to analysis due to low enrollment.||||||
1320024|NCT02299206|Primary|Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.|For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.|14 days|Study was terminated prior to analysis due to low enrollment.||||||
1320025|NCT02299089|Other Pre-specified|To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)|"Number of bowel movements and flushing during period 0 and 1, data is presented as patients experience symptoms~Bowel movement without flushing Bowel movement and flushing No Bowel movement or Flushing"|Baseline (Day 0), Day 84|Pharmacokinetic population|||participants|||Number
1320026|NCT02299089|Secondary|CAM2029 Effect on Growth Hormone (GH) (Acromegaly)|GH (growth hormone) levels measured on Day 84 in patients with acromegaly|Day 84|Pharmacokinetic population (5 acromegaly patients)|||participants|||Number
1320027|NCT02299089|Secondary|CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)|"Data is presented as number of patients~Within the reference limits (see below)~Above ULN (Upper Limits of Normal)~In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below.~REFERENCE VALUES~Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years)~Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)"|Day 84|Pharmacokinetic population (5 acromegaly subjects total)|||participants|||Number
1320028|NCT02299089|Secondary|Number of Adverse Events and Serious Adverse Events|Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0)|Day -28 to Day 84|Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84)|||Participants|||Count of Participants
1320029|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.|"Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL).~Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)"|(Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)|Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.|||ng/mL||Standard Deviation|Mean
1320030|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough|"Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84; Ctrough (ng/mL).~Ctrough; Concentration levels assessed prior to next injection for CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)"|(Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)|Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.|||ng/ml||Standard Deviation|Mean
1320031|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax|"Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL).~Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL)"|Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
1320032|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough|"Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Ctrough (ng/mL).~Ctrough; Concentration levels assessed prior to next injection for the final (Sandostatin LAR) dosing interval (ng/mL)."|Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
1320033|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.|"Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day*ng/mL).~AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals"|(Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)|Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.|||day*ng/mL||Standard Deviation|Mean
1320034|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC|"Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day*ng/mL).~AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day*ng/mL) for Sandostatin LAR."|Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)|Pharmacokinetic population|||day*ng/mL||Standard Deviation|Mean
1320035|NCT02299076|Primary|Outcome of Smoking Cessation Intervention|Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.|Every 30 days for up to 6 months post-enrollment||||Participants|||Count of Participants
1320036|NCT02299076|Primary|Average Number of Completed Sessions Per Participant|Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.|Every 30 days for up to 6 months post-enrollment||||Average Number of Sessions|Sessions|Inter-Quartile Range|Mean
1320037|NCT02298868|Secondary|Change in Severity of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured severity on a 0-10 analog scale (0 is no pain, 10 is most severe pain) and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess severity of muscle cramps. This was then compared to the end of therapy severity to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)||||units on a scale||Standard Deviation|Mean
1320141|NCT02295644|Primary|Self Report of Pain|Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever|Immediately before and after the intervention, difference used.||||Scores on pain intensity scale||Standard Deviation|Mean
1320038|NCT02298868|Secondary|Change in Frequency of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess frequency of muscle cramps. This was then compared to the end of therapy frequency to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)||||days/week||Standard Deviation|Mean
1320039|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)|Proportion of patients with somnolence at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
1320040|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)|Proportion of patients with endephalopathy at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
1320041|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)|Proportion of patients with dizziness at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
1320042|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)|Proportion of patients with nausea at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
1320043|NCT02298868|Secondary|Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured severity in a 0-10 analog scale (0 is no pain and 10 is most severe pain). These measures were repeated after 4 weeks of therapy and the difference was assessed (4 weeks of therapy-Baseline).|Baseline to end of 4 weeks of therapy||||units on a scale||Standard Deviation|Mean
1320044|NCT02298868|Secondary|Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps. This measures was repeated after 4 weeks of therapy and reported as the mean decrease in frequency of muscle cramps (4 weeks of therapy-Baseline).|Baseline to 4 weeks of therapy||||days/week||Standard Deviation|Mean
1320045|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)|Proportion of patients with headache at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
1320046|NCT02298842|Secondary|Platelet Morphology|Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||score on a scale||Standard Deviation|Mean
1320047|NCT02298842|Secondary|Percent of Platelets Exhibiting Hypotonic Shock Response|Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% of hypotonic shock response||Standard Deviation|Mean
1320048|NCT02298842|Secondary|Percent of Extent of Shape Change|Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% of extent of shape change||Standard Deviation|Mean
1320049|NCT02298842|Secondary|Percent of Platelets Activated as Measured by P-selectin|Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||Percent of Platelets Activated||Standard Deviation|Mean
1320050|NCT02298842|Secondary|Platelet Morphology|Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||scores on a scale||Standard Deviation|Mean
1320051|NCT02298842|Secondary|Percent of Platelets Exhibiting Hypotonic Shock Response|Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% of hypotonic shock response||Standard Deviation|Mean
1320052|NCT02298842|Secondary|Percent of Extent of Shape Change|Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% extent of shape change||Standard Deviation|Mean
1320067|NCT02298192|Primary|Change From Baseline in HbA1c|Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.|||percentage||Standard Deviation|Mean
1320054|NCT02298842|Primary|pH of Platelets at Day 7|The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||pH||Standard Deviation|Mean
1320055|NCT02298842|Primary|pH of Platelets at Day 5|The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||pH||Standard Deviation|Mean
1320056|NCT02298803|Secondary|deltaQTc|deltaQTc is the difference in QTc observed during periods of hypoglycemia and periods of normoglycemia (for those participants who experienced nocturnal hypoglycemia)|Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring||||milliseconds|||Number
1320057|NCT02298803|Secondary|Mean Amplitude of Glycemic Excursion (MAGE)|The MAGE results (in mmol/L) for the eight participants who experienced nocturnal hypoglycemia are included in the table below.|48 hours of continuous glucose monitoring|Only those participants who experienced nocturnal hypoglycemia (BGL <3.5 mmol/L for >20 minutes) are included in the analysis population|||mmol/L|||Number
1320058|NCT02298803|Secondary|Pearson's Correlation Coefficient of Delta QTc and a Measure of Glucose Variability, MAGE (Mean Amplitude of Glycemic Excursion).|MAGE, a commonly used index of glucose variability, was calculated using data obtained during continuous glucose monitoring. Analysis of correlation between MAGE and delta QTc was undertaken. Please note delta QTc represents the difference between average QTc length during hypoglycemia and average QTc length during normoglycemia.|Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring|The eight study participants who experienced nocturnal hypoglycemia are included in the analysis population.|||Correlation coefficient|||Number
1320059|NCT02298803|Primary|Change in Corrected QT Interval During Day Time Hypoglycaemia|The day time period for the study spanned from 7 am in the morning until 11 pm in the evening on two consecutive days. The change in the corrected QT interval during day time hypoglycemia was determined by calculating the difference between the average QTc interval length during periods of hypoglycemia (blood glucose level <3.5 mmol/L) and the average QTc interval length during periods of normoglycemia (blood glucose level >3.5 mmol/L) for the day time period. The average QTc interval was calculated using an individually optimised correction formula. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was positive, the participant experienced QTc prolongation during hypoglycemia. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was negative, the participant experienced QTc shortening during hypoglycemia.|Day time period (0700-2300) during the 48 hours of Holter monitoring||||Participants|||Count of Participants
1320060|NCT02298803|Primary|Change in the Corrected QT-interval During Nocturnal Hypoglycemia|The nocturnal time period for the study spanned from 11 pm in the evening until 7 am the following morning on two consecutive days. The change in the corrected QT interval during nocturnal hypoglycemia was determined by calculating the difference between the average QTc interval length during periods of hypoglycemia (blood glucose level <3.5 mmol/L) and the average QTc interval length during periods of normoglycemia (blood glucose level >3.5 mmol/L) for the nocturnal time period. The average QTc interval was calculated using an individually optimised correction formula. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was positive, the participant experienced QTc prolongation during hypoglycemia. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was negative, the participant experienced QTc shortening during hypoglycemia.|Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring||||Participants|||Count of Participants
1320061|NCT02298361|Primary|Proportion of Patients Who Lost Medicaid Coverage|Proportion of participants who lost Medicaid coverage after a period of insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to lose coverage).|6 months pre- through 16 months post-tool implementation||||participants|||Number
1320062|NCT02298361|Primary|Proportion of Patients Who Gained Medicaid Coverage|Proportion of participants who gained Medicaid coverage after a period of uninsurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to gain coverage).|6 months pre- through 16 months post-tool implementation||||participants|||Number
1320063|NCT02298361|Primary|Percent of Study Period Covered by Medicaid|Percent of total days in 22-month assessment period that each child was covered by Medicaid insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources).|6 months pre- through 16 months post-tool implementation||||participants|||Number
1320064|NCT02298192|Secondary|Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0-32|"Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated. One subject in the IDegLira (1WT) arm did not contribute to the analysis for this endpoint."|||Number of episodes|||Number
1320065|NCT02298192|Secondary|HbA1c Below or Equal to 6.5%|Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.|||particpants|||Number
1320068|NCT02298179|Secondary|Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N|Immunogenicity was measured in terms of the ratio of RSV F serum Nab titers to each of the RSV F serum total binding antibody titers to RSV proteins F, G and N at Days 1, 29, 57 and 181.|At Day 1, Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Adjusted Geometric Mean Ratio||95% Confidence Interval|Geometric Mean
1320069|NCT02298179|Secondary|Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1|Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose), with serum total binding antibody titers to each of the RSV proteins F, G, and N greater than the 3rd quartile of serum total binding antibody titers to RSV protein F at Day 1 (baseline).|At Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
1320070|NCT02298179|Secondary|Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N|Immunogenicity was measured in terms of the percentage of subjects with a ≥ 4-fold increase in serum total binding antibody to each of the RSV Proteins F, G and N from Day 1 (baseline) to all time points (Day 29 [28 days after the first dose], Day 57 [28 days after the second dose], and Day 181 [six months after the first dose]).|At Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
1320071|NCT02298179|Secondary|Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N|Immunogenicity was measured in terms of the geometric mean titers (GMTs) of the serum total binding antibody to each of the RSV proteins F, G and N at Day 1 (baseline), Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose).|At Day 1, Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Titers||95% Confidence Interval|Geometric Mean
1320072|NCT02298179|Secondary|Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1|Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose) with serum anti-RSV NAb titers greater than the 3rd quartile of serum anti-RSV NAb titers at Day 1 (baseline).|At Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
1320073|NCT02298179|Secondary|Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer|Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers from Day 1 to Day 29 (28 days after the first dose) and from Day 1 to Day 181 (six months after the first dose).|At Day 29 and at Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
1320074|NCT02298179|Secondary|Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers|Immunogenicity was measured in terms of GMTs of the serum anti-RSV neutralizing antibody (NAb) titers at Day 1, Day 29 (28 days after the first dose) and Day 181 (six months after the first dose).|At Day 1, Day 29 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29 and at Day 181.|||Titers||95% Confidence Interval|Geometric Mean
1320075|NCT02298179|Primary|Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)|"SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination.~Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment."|From study start (Day 1) until study completion (Day 394)|The analysis was based on the Unsolicited Safety Set, which included all subjects in the Exposed population with unsolicited AE data collected from study start (Day 1) until study completion (Day 394).|||Participants|||Count of Participants
1320076|NCT02298179|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|From Day 1 to Day 28 after each vaccination|The analysis was based on the Unsolicited Safety Set, which included all subjects in the Exposed population with unsolicited AE data collected after each vaccination.|||Participants|||Count of Participants
1320541|NCT02287623|Secondary|Postoperative Opioid Use|Use of opioids during 24-48 hours after surgery|24-48 hours||||Micrograms of fentanyl equivalents||Inter-Quartile Range|Median
1320077|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hours) to Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320078|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|From Day 4 through Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320079|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hours) through Day 3 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320080|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|Within 30 minutes after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320081|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hours) to Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320082|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|From Day 4 through Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320083|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hour) through Day 3 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320084|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|Within 30 minutes after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
1320085|NCT02298179|Primary|Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers|Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).|At Day 57|The analysis was based on PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and and for whom immunogenicity results collected from Day 1 (baseline) up to Day 57 were available at Day 1 and Day 57.|||Percentage of subjects||95% Confidence Interval|Number
1320086|NCT02298179|Primary|Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers|Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).|At Day 57|The analysis was based on the Per-Protocol Set (PPS), which included all subjects in the Full Analysis Set (FAS) Immunogenicity population who were not excluded due to the reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 57.|||Titers||95% Confidence Interval|Geometric Mean
1320087|NCT02297841|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24, 48, and 72 hours after patch application||||participants|||Number
1320088|NCT02297815|Secondary|Symptoms Present on Day 3|During 5-10 day interview, parents were asked about symptoms related to child's illness (otitis media: fever, ear pain, decreased appetite; sinusitis: fever, face/head pain, decreased appetite; pharyngitis: throat pain, fever, decreased appetite). Parent was asked if symptoms was present at diagnosis. If yes, had the symptom resolved. If yes, when. We assessed whether symptoms present at day 3 after diagnosis.|3 days after ARTI diagnosis|Among subjects who reported having at least one symptom at the time of diagnosis|||Participants|||Count of Participants
1320090|NCT02297815|Secondary|Required Additional Childcare|Among children who attend school or daycare, parent or another caretaker had to miss work or an obligation due to child's illness OR additional childcare had to be sought for the child.|5-10 days after ARTI diagnosis|Among children who attend school or daycare|||Participants|||Count of Participants
1320091|NCT02297815|Secondary|Missed School or Daycare From Illness|Among children who attend school or daycare, child had to miss school or day care due to illness|5-10 days after ARTI diagnosis|Among children who attend school or daycare|||Participants|||Count of Participants
1320092|NCT02297815|Primary|Health Related Quality of Life Score|The health related quality of life score was obtained using the PedsQL(TM) (Mapi Research Trust, Lyon, France. www.pedsql.org) Parent-Proxy Report Generic Core Scales and Parent Report Infant Scales administered during the 5-10 day interview. Briefly, the PedsQL(TM) is a 23-item questionnaire assessing developmentally appropriate metrics (questions vary by age group: 1-12 months, 13-24 months, 2-4 years, 5-7 years, 8-12 years) related to core dimensions of health and role functioning. Our primary outcome was the Total Scale Score, which is a summary score of physical, emotional, social, and school functioning. The score range is zero to 100 and higher scores indicate a better health-related quality of life.|5-10 days after ARTI diagnosis|1 subject did not respond to enough of the questions to obtain a score|||scores on a scale||Standard Deviation|Geometric Mean
1320093|NCT02297308|Secondary|Bleeding Complications at the Access Site|VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding|within 30 days of TAVI procedure||||participants|||Number
1320094|NCT02297308|Primary|Vascular Access Site Complications|Rate of VARC-2 defined vascular complications within 30 days of TAVI.|withn 30 days of TAVI procedure||||participants|||Number
1320095|NCT02297230|Secondary|To Acquire Descriptive Information on Patient Adherence to Therapy and on Quality of Life During Treatment.|Data were not collected as PI left institution prior to enrollment completion. Planned Statistical analysis was not performed for this secondary outcome measure.|12/2014 (up to 12 years)|||||||
1320096|NCT02297230|Secondary|To Store Core Biopsies of the Original Tumor Before and After Treatment (From the Surgical Specimen) for Future Molecular Biology Studies in LABC.||12/2014 (up to 12 years)|Data were not collected as PI left institution prior to enrollment completion. PI terminated protocol.||||||
1320097|NCT02297230|Secondary|To Assess the Pathological Response Rate and Compare it to That Achieved in Our Previous Phase I-II Trials of Concurrent Chemo-radiation.|Planned Statistical analysis was not performed for this secondary outcome measure.|12/2014 (up to 12 years)|Planned Statistical analysis was not performed for this secondary outcome measure. Study Terminated prematurely; PI left institution;||||||
1320098|NCT02297230|Primary|Feasibility & Efficacy of Chemo-radiation While Targeting Treatment, Based on: Original Tumor Characteristics; to be Followed by [Need for] Conventional Post-operative Chemotherapy||12/2014 (up to 12 years)|Data were not collected as PI left institution prior to enrollment completion. PI terminated protocol.||||||
1320099|NCT02297100|Other Pre-specified|Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.||30 days and 90 days post treatment|Data was not collected on one participant in the experimental group at 30 and 90 days post treatment. Data was not collected on two individuals at 30 days post treatment in the control group.|||mL||Standard Deviation|Mean
1320100|NCT02297100|Secondary|Change in Patient Performance in Uroflowmetry.|Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.|30 days and 90 days post treatment|No data was collected for two participants in the experimental group and one participant in the control group at 30 days. No data was collected for one participant in the experimental group at 90 days.|||ml/s||Standard Deviation|Mean
1320101|NCT02297100|Primary|The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire|The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes.|30 and 90 days post-treatment|One participant from the experimental group was lost to follow-up. Data was not collected at 30 days for bother and symptom for one participant in the control group.|||units on a scale||Standard Deviation|Mean
1320102|NCT02297100|Primary|The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.|The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.|30 and 90 days post treatment|One participant was lost to follow-up in the experimental group and no data was collected at 30 days on one participant in the control group.|||units on a scale||Standard Deviation|Mean
1320103|NCT02296931|Primary|Error in the Total Volume Dispensed and Flow Rate|This is the error value for the volume dispensed by the AutoSyp device relative to the volume intended to be dispensed. Preeclamptic subjects received an initial loading dose followed by a maintenance dose. The loading dose had a flow rate of 60 mL/hr and delivered 20 mL in a single 20 mL syringe. The maintenance dose was 5 mL/hr and dispensed 120 mL total through two 60 mL syringes. The healthy subjects experienced variable flow rates and dispensed volumes, so they do not have the same variables as the pre-eclamptic pregnant women in the outcome data tables below. Because of these differences in dosing the two arms of the study, healthy women and preeclamptic women have different outcome measure data.|1 day visit||||percentage of error||Full Range|Mean
1320104|NCT02296840|Secondary|Number of Participants With Post-operative Bleeding|The occurrence of post-operative bleeding at the surgical site for each participant will be assessed by review of the participant’s study records and clinical records and by questioning the caregiver in follow-up. If postoperative bleeding has occurred, details of the episode of bleeding will also be obtained (requirement for surgical intervention, observation at home, or observation at the hospital).|2 weeks after surgery|All study participants are included in this analysis.|||Participants|||Count of Participants
1320146|NCT02295020|Primary|Synovial Fluid Analysis (MCP - 1)|Monocyte chemotactic protein-1 - 1|Week 8 -day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
1320105|NCT02296840|Primary|Faces Pain Score|Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980.|2 weeks after surgery|Children who returned the completed the survey at two weeks post-surgery.|||units on a scale||Standard Deviation|Mean
1320106|NCT02296606|Primary|1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners|Two human assessors conducted and recorded the results of a clinical pupillary assessment on one patient within 5 minutes of one another. The researcher then conducted and recorded pupillary information on the same patient (within the same 5 minute window) using the NeurOptics Pupillometer.|9 months of pupillary assessments||||Kappa score|paired pupil assessments|95% Confidence Interval|Mean
1320107|NCT02296476|Secondary|Area Under the Concentration-time Curve of MK-8628 From Time 0 to Infinity (AUC 0-∞)|Blood samples were obtained at specified time points for the PK analysis of AUC 0-∞ of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The AUC 0-∞ was estimated indirectly using the dose and CL/F values. The AUC 0-∞ of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||μg•hours/Liter||Standard Deviation|Mean
1320108|NCT02296476|Secondary|Observed Minimum Concentration (Cmin) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Cmin of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. A single Cmin value for MK-8628 was estimated using dose and steady-state predose concentrations of MK-8628 on Days 29 and 57. The Cmin of MK-8628 after oral administration is presented.|Predose on Days 29 and 57|All participants who received MK-8628 and had predose blood samples drawn on Days 29 and 57 for steady state MK-8628 concentration. Participants in the 160 mg dose group were not analyzed for Cmin because they discontinued before Day 29.|||μg/Liter||Standard Deviation|Mean
1320109|NCT02296476|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Vz/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Vz/F was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Vz/F of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||Liters||Standard Deviation|Mean
1320110|NCT02296476|Secondary|Apparent Total Body Clearance (Cl/F) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Cl/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Cl/F was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Cl/F of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||Liters/hour||Standard Deviation|Mean
1320111|NCT02296476|Secondary|Apparent Terminal Half-Life (t1/2) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of t1/2 of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and t1/2 was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The t1/2 of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||hours||Standard Deviation|Mean
1320112|NCT02296476|Secondary|Time to Maximum Concentration (Tmax) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Tmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Tmax was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Tmax of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||hours||Standard Deviation|Mean
1320113|NCT02296476|Secondary|Observed Maximum Concentration (Cmax) of MK-8628|Blood samples were obtained at specified time points for the pharmacokinetic (PK) analysis of Cmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Cmax was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Cmax of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||μg/Liter||Standard Deviation|Mean
1320114|NCT02296476|Secondary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1|A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting >7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality lasting >7 days, or intolerable Grade 2 non-hematologic toxicity resulting in study treatment discontinuation or delay >7 days with or without dose reduction.|Up to Cycle 1 (Up to 28 days)|All participants who received at least 21 days of the planned dose of study drug during the first 28-day cycle or experienced a DLT.|||Participants|||Count of Participants
1320115|NCT02296476|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|The number of participants who discontinued study treatment due to an AE is presented.|Up to 6 Months|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
1320142|NCT02295280|Primary|Number of Participants With Adequate Relief of Headache as a Measure of Efficacy|Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.|Primary outcome was six hours post administration|Number in each arm with data at 6 hours who received either metoclopramide and diphenhydramine IV or codeine.|||Participants|||Count of Participants
1320116|NCT02296476|Secondary|Number of Participants Who Experienced at Least One Toxicity Grade 3-5 AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced ≥1 Grade 3-5 AE per National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03 criteria is presented. Grade 3 was classified as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care; Grade 4 was classified as potentially life-threatening or disabling; and Grade 5 was an AE resulting in death.|Up to 6 Months|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
1320117|NCT02296476|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced at least one AE is presented.|Up to 6 Months|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
1320118|NCT02296476|Secondary|Progression-free Survival|Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to RANO 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS was measured as the number of participants who were alive and progression-free for up to 6 months.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression.|||Participants|||Count of Participants
1320119|NCT02296476|Secondary|Overall Survival (OS)|OS was the time from the start of study treatment to the date of death. Participants were to be censored at their last contact if they were still alive at the cut-off date. OS was calculated for all participants who did not discontinue from the study due to disease progression.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since all participants discontinued the study due to disease progression, OS could not be calculated.||||||
1320120|NCT02296476|Secondary|Duration of Response (DOR)|DOR was the time from the first documented CR (complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically)or PR (≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically), as assessed by RANO 2010, until documentation of disease progression, or the date of the last tumor assessment (if there was no documented progression), or the last tumor assessment before the start of further antitumor therapy. DOR was calculated for all participants who experienced a CR or PR.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since no participants experienced a CR or PR, DOR could not be calculated.||||||
1320121|NCT02296476|Secondary|Objective Response Rate (ORR)|ORR was defined as the number of participants in the analysis population who experienced a Complete Response (CR: complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically) or a Partial Response (PR: ≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically) and was assessed using RANO 2010.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression.|||Participants|||Count of Participants
1320122|NCT02296476|Primary|Progression-free Survival (PFS) at 6 Months|Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS at 6 months was measured as the percentage of participants who were alive and progression-free at Month 6. PFS at 6 months was calculated for all participants who were actively enrolled in the study at the 6-month time point.|Month 6|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study magnetic resonance imaging (MRI). Since no participants reached the 6-month time point in the study, PFS at 6 months could not be calculated.||||||
1320123|NCT02296138|Secondary|Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.|Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Number of patients|||Number
1320143|NCT02295020|Primary|Visual Analog Scale|identifies pain level|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.||||||
1320144|NCT02295020|Primary|WOMAC|assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.||||||
1320124|NCT02296138|Secondary|Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.|Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Number of patients|||Number
1320125|NCT02296138|Secondary|Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.|Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient−year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Rate per patient−year||95% Confidence Interval|Least Squares Mean
1320126|NCT02296138|Secondary|Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.|Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Number of patients|||Number
1320127|NCT02296138|Primary|Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.|Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient−year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Rate per patient−year||99% Confidence Interval|Least Squares Mean
1320128|NCT02296099|Other Pre-specified|Pain at Bedtime (Average Pain)|Before going to bed each night the patient will record the average level of pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||score on a scale||Inter-Quartile Range|Median
1320129|NCT02296099|Other Pre-specified|Pain at Bedtime (Most Intense Pain)|Before going to bed each night the patient will record the most intense pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||score on a scale||Inter-Quartile Range|Median
1320130|NCT02296099|Other Pre-specified|Pain at Bedtime (Current Level of Pain)|Before going to bed each night the patient will record their pain level at that moment using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||score on a scale||Inter-Quartile Range|Median
1320131|NCT02296099|Other Pre-specified|Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit|A likert type scale will be used to have the patient rate their satisfaction with pain control at their two week postoperative visit. Count information for those who were very satisfied were provided.|2 weeks||||Participants|||Count of Participants
1320132|NCT02296099|Secondary|Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit|A likert type scale will be used to have the patient rate their satisfaction with pain control at their one week postoperative visit. Count information for those who were very satisfied were provided.|1 week||||Participants|||Count of Participants
1320133|NCT02296099|Secondary|Total Narcotic Consumption|Cumulative consumption postoperative days 1 - 3|Day 1 - 3||||morphine equivalents||Standard Deviation|Mean
1320134|NCT02296099|Secondary|Pain at Four Hours After Discharge Home|A visual analog scale (VAS) will be used to have the patient rate her pain four hours after being discharged home. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|1 day, 4 hours after discharge from Same Day Surgery||||score on a scale||Inter-Quartile Range|Median
1320135|NCT02296099|Secondary|Pain Upon Discharge From Same Day Surgery|A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from same day surgery. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|1 day||||score on a scale||Inter-Quartile Range|Median
1320136|NCT02296099|Secondary|Pain Upon Discharge From Post-anesthesia Care Unit (PACU)|A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from the PACU. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|1 day||||score on a scale||Inter-Quartile Range|Median
1320137|NCT02296099|Primary|Pain in the Morning|A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||scores on a scale||Inter-Quartile Range|Median
1320138|NCT02295774|Primary|Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy|Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.|2 weeks|FAS = 10|||number of positive biopsies|||Number
1320139|NCT02295644|Primary|Intraoral Muscle Temperature|Using digital thermometer on buccal mucosa, degrees celsius.|Immediately before and after the intervention, difference used.||||degrees Celsius, post minus pre||Standard Deviation|Mean
1320140|NCT02295644|Primary|Pressure Pain Threshold of the Masseter Muscle|Measuring pressure pain threshold using digital algometer|Immediately before and after the intervention, difference used.||||Kpa/Cm^2||Standard Deviation|Mean
1320147|NCT02295020|Primary|Synovial Fluid Analysis (MIP - 1alpha)|Macrophage Inflammatory Proteins - 1alpha|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
1320148|NCT02295020|Primary|Synovial Fluid Analysis (TNF-alpha)|Tumor necrosis factor - alpha in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
1320149|NCT02295020|Primary|Synovial Fluid Analysis (IL-8)|Interleukine 8 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
1320150|NCT02295020|Primary|Synovial Fluid Analysis (IL-6)|Interleukine 6 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
1320151|NCT02295020|Primary|KOOS - QOL|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||pg/mL||95% Confidence Interval|Least Squares Mean
1320152|NCT02295020|Primary|KOOS - Sport/Rec|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
1320153|NCT02295020|Primary|KOOS - ADL|Value at 8 weeks - value at day 0|week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
1320154|NCT02295020|Primary|KOOS - Symptoms|Value at 8 weeks - value at day 0|Week 8 - Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
1320155|NCT02295020|Primary|KOOS - Pain|Value at 8 weeks - value at day 0|Week 8- Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
1320156|NCT02294773|Other Pre-specified|Pregnancy Rate Per Body Mass Index Category||Up to cycle day 35||||pregnancies per cycle|||Number
1320157|NCT02294773|Other Pre-specified|Pregnancy Rate Per Semen Morphology Score|Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores.|Up to cycle day 35||||pregnancies per cycle|||Number
1320158|NCT02294773|Other Pre-specified|Pregnancy Rate Per Female Partner Age|Pregnancy rate will be compared between patients <35 and >35 at time of study entry.|Up to cycle day 35||||pregnancies per cycle|||Number
1320159|NCT02294773|Other Pre-specified|Per Cycle Pregnancy Rate Based on Infertility Diagnosis||Up to cycle day 35||||pregnancies per cycle|||Number
1320160|NCT02294773|Primary|Number of Pregnancies Achieved Per Menstrual Cycle.||Up to 3 months||||pregnancies per cycle|||Number
1320161|NCT02294734|Secondary|Number of Participants With Treatment Failures|Treatment failure types are presented as: recurrent exacerbations, prolonged treatment of current exacerbation (beyond 14 days), additional treatment with systemic / oral corticosteroids and / or antibiotics, and requirement for invasive mechanical ventilation.|13 weeks|ITT Population|||Participants|||Number
1320162|NCT02294734|Secondary|Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84|The chronic obstructive pulmonary disease (COPD) assessement test (CAT) and Modified Medical Research Council (MMRC) Dyspnea Scale were completed at the indicated timepoints: Baseline, Day 28 and Day 84. CAT and MMRC scales are prestned as: 1.I never cough/I cough all the time 2.I have no phelgm in my chest at all/My chest is completely full of phelgm 3. My chest does not feel tight at all/My chest feels very tight 4.Walk up hilll or stairs not breathless/Walk up hill or stairs very breathless 5. Not limited doing any home activities/Very limited doing any home activities 6. Confident leaving home/No confident leaving home 7. I sleep soundly/I don't sleep soundly because of my lung condition and 8. I have lots of energy/I have no energy at all. Baseline is defined as the assessment on Day 1. Score 0 indicates not troubled with breathlessness to 4:too breathless. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||Scores on a scale||Standard Deviation|Mean
1320163|NCT02294734|Secondary|Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment|Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).Note: values mentioned as 95% confidence interval below are in fact values of 95% Credible Interval.|Baseline, Day 28 and Day 84|ITT Population|||1/KPA*S||95% Confidence Interval|Median
1320164|NCT02294734|Secondary|Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment|sRaw is the measure of specific resistance. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||KPa*s||Standard Deviation|Mean
1320165|NCT02294734|Secondary|Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment|Functional residual capacity is the volume of air present in the lungs at the end of passive expiration. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||L||Standard Deviation|Mean
1320205|NCT02294604|Secondary|Microorganisms on Hands After Scrubbing|The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling||||colony forming unit||Standard Error|Mean
1320542|NCT02287623|Secondary|Post Operative Length of Stay||up to 30 days after surgery||||HOURS||Inter-Quartile Range|Median
1320166|NCT02294734|Secondary|Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment|Residual volume is a lung volume representing the amount of air left in the lungs after a forced exhalation. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.|Baseline, Day 28 and Day 84|ITT Population|||L||95% Confidence Interval|Median
1320167|NCT02294734|Secondary|Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment|TLC is the maximum amount of air that can fill the lungs. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.|Baseline, Day 28 and Day 84|ITT Population|||L||95% Confidence Interval|Median
1320168|NCT02294734|Secondary|Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment|DLco is diffusing capacity o f the lungs for carbon monoxide and is defined as the extent to which oxygen passes from the air sacs of the lungs into the blood. KCO is the carbon monoxide transfer coefficient. It is an index of the efficiency of alveolar transfer of carbon monoxide. Baseline is defined as the assessment on Day 2 and percent change from Baseline is the post-Baseline value minus Baseline value/100. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||Percent||Standard Deviation|Mean
1320169|NCT02294734|Secondary|Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28, and Day 84|ITT Population|||L/min||Standard Deviation|Mean
1320170|NCT02294734|Secondary|Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily|FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28, and Day 84|ITT Population|||mL||Standard Deviation|Mean
1320171|NCT02294734|Secondary|Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment|Trough concentrations are presented for Pre-dose Day 12, Pre-dose Day 28, Pre-dose Day 56, and Pre-dose Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose Day 12, Day 28, Day 56, and Day 84|PK Population|||pg/mL||Standard Deviation|Mean
1320172|NCT02294734|Secondary|Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose|Plasma samples were collected at pre-dose, 5 minutes (min), 3 hrs, and 24 hrs post-dose on Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Population: all participants in the Safety Population for whom a PK sample was obtained and analyzed. Safety Population comprises of all participants who were randomized.|Pre-dose, 5 min, 3 hrs and 24 hrs|Pharmacokinetic (PK) Population|||pg/mL||Standard Deviation|Mean
1320173|NCT02294734|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)|12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Clinically non-significant (CN) and Clinically significant (CS) abnormal ECG measurements are presented for Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population|||Participants|||Number
1320174|NCT02294734|Secondary|Number of Participants With Abnormal Vital Signs|Vital signs included high and low diastolic and systolic blood presure (BP), and high and low heart rate (HR). Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline . Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population|||Participants|||Number
1320175|NCT02294734|Secondary|Number of Participants With Abnormal Clinical Chemistry Parameters|Clinical Chemistry parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Calcium (Ca), Glucose, Potassium (K), Sodium (Na), and Total Bilirubin (TBL) at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population|||Participants|||Number
1320176|NCT02294734|Secondary|Number of Participants With Abnormal Hematology Parameters|Hematology parameter included Hematocrit (HCT), Hemoglobin (HB), Lymphocytes (LC), Platelet Count (PC), Total Neutrophils (TN), and White Blood Cell (WBC) count at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 Days)|All Subjects Population|||Participants|||Number
1320206|NCT02294604|Primary|Microorganisms on Hands Before Scrubbing|The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling||||colony forming unit||Standard Error|Mean
1320543|NCT02287623|Secondary|Number of Patients With Post Operative Nausea/Vomiting||0-72 hours||||participants|||Number
1320177|NCT02294734|Secondary|Number of Participants With Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were collected from the start of study treatment until the follow-up contact.|From start of IP through the Study Phase (84 days post-dose) (assessed up to follow-up duration of approximately 100 days)|All Subjects Population: all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1320178|NCT02294734|Secondary|Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment|Imaging trachea length/diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length/diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||ratio||Standard Deviation|Mean
1320179|NCT02294734|Secondary|Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment|Imaging trachea length and diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Millimeter (mm)||Standard Deviation|Mean
1320180|NCT02294734|Secondary|Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28|Change from Baseline in lung lobar volumes was measured at functional residual volume (FRC) and total lung capacity (TLC) scan conditions. Data was collected at longitudinal time points: Day 12 & Day 28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points the baseline is screening. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||L||95% Confidence Interval|Geometric Mean
1320181|NCT02294734|Secondary|Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|siRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Kpa*s||95% Confidence Interval|Geometric Mean
1320182|NCT02294734|Secondary|Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|iRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Kilopascal (Kpa)*s/L||95% Confidence Interval|Geometric Mean
1320183|NCT02294734|Secondary|Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|iVaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Milliliter (mL)||95% Confidence Interval|Geometric Mean
1320194|NCT02294682|Secondary|Change From Baseline in Hemoglobin, Protein and Albumin at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hemoglobin, total protein and albumin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Gram (G)/Liter (L)||Standard Deviation|Mean
1320207|NCT02294474|Other Pre-specified|Change in Daily Insulin Dose From Baseline to Week 26|Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 value.|Baseline, Week 26|Analysis was performed on safety population. Here, number analyzed in each row = participants with available data for specified categories.|||U/kg||Standard Deviation|Mean
1320184|NCT02294734|Primary|Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|siVaw is a measure of the volume in an individual’s airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|Intention to Treat (ITT) Population excluding the subject with a pacemaker.|||Milliliter/Liter (mL/L)||95% Confidence Interval|Geometric Mean
1320185|NCT02294682|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Dipstick urinalysis was done for glucose, ketones, occult blood, protein, potential hydrogen (pH) and specific gravity at Baseline visit Day 1 (pre-dose) and Test-of-Cure visit (Day 4 to 8). Results were presented as negative (normal) or other findings reported only if observed under microscopic examination trace, 1+, 2+, 3+, 4+ and 5+ glucose, ketones, occult blood and protein. pH results were categorized as per their pH values. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Participants|||Number
1320186|NCT02294682|Secondary|Change From Baseline in Erythrocytes Mean Corpuscular Volume at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular volume. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Femtoliters||Standard Deviation|Mean
1320187|NCT02294682|Secondary|Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular hemoglobin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Picograms||Standard Deviation|Mean
1320188|NCT02294682|Secondary|Change From Baseline in Erythrocytes at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes (red blood cell count). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)||||10^12/L||Standard Deviation|Mean
1320189|NCT02294682|Secondary|Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Urea at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate chloride, calcium, glucose, potassium, sodium and urea (blood urea nitrogen). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Millimole (MMOL)/L||Standard Deviation|Mean
1320190|NCT02294682|Secondary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase and Alkaline Phosphatase at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||International units (IU)/ L||Standard Deviation|Mean
1320191|NCT02294682|Secondary|Change From Baseline in Bilirubin, Direct Bilirubin and Creatinine at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate bilirubin, direct bilirubin and creatinine. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Micromole (UMOL)/ L||Standard Deviation|Mean
1320192|NCT02294682|Secondary|Change From Baseline in Lymphocyte, Monocyte, Neutrophil Basophil, Eosinophil, Leukocyte and Platelet Count at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate neutrophil, lymphocyte, basophil, eosinophil, monocyte, leukocyte and platelet count. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||10^9 cells/L||Standard Deviation|Mean
1320193|NCT02294682|Secondary|Change From Baseline in Hematocrit at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hematocrit. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Proportion of blood||Standard Deviation|Mean
1320544|NCT02287623|Secondary|Post Operative Opioid Use||48-72 hours||||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
1320195|NCT02294682|Secondary|Number of Participants With Abnormal Physical Examination Finding|Physical examination of respiratory, cardiovascular, abdomen, gastrointestinal, urogenital systems, pharyngeal and rectal examinations with collections of microbiology specimen was performed at the Baseline and TOC (Day 4 to 8) visit. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Participants|||Number
1320196|NCT02294682|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A single 12-lead ECGs were obtained at the Baseline, 2 hour post-dose, and at the TOC (Day 4 to 8) visit using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG was obtained prior to any vital sign measurements or blood draws scheduled on the same assessment day. For participants enrolled under protocol amendment 1, ECG was measured at Baseline visit Day 1 (pre-dose) only. ECG assessments were presented as abnormal-clinically significant (CS) and abnormal-not clinically significant (NCS) at the indicated time points. Only those participants available at the specified time points were analyzed (represented by n=X , X in the category titles).|Baseline visit and up to Day 8|Safety Population|||Participants|||Number
1320197|NCT02294682|Secondary|Change From Baseline in Respiratory Rate at the Indicated Time Points|Respiratory rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements was obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC Visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Breaths per minute||Standard Deviation|Mean
1320198|NCT02294682|Secondary|Change From Baseline in Temperature at the Indicated Time Points|Temperature was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Celsius||Standard Deviation|Mean
1320199|NCT02294682|Secondary|Change From Baseline in Pulse Rate at the Indicated Time Points|Pulse rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Beats per minute||Standard Deviation|Mean
1320200|NCT02294682|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points|BP was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8).Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1320201|NCT02294682|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia (defined as alanine aminotransferase [ALT] >=3 times upper limit of normal [ULN] and bilirubin >=2 times ULN [>35 percent direct] [or ALT >=3 times ULN and international normalization ratio INR>1.5, if INR is measured].|From start of the study treatment until Test-of-Cure visit (Day 4 to 8)|Safety Population: comprised of all randomized participants who received any dose of study medication.|||Participants|||Number
1320202|NCT02294682|Primary|Number of Participants With Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit|Pre-treatment urogenital, pharyngeal, and rectal swab specimens were obtained for bacteriological culture for neisseria (N.) gonorrhoeae at the Baseline visit. Test- of-Cure was defined by infection site (that is urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment. Pre-treatment urogenital specimens were obtained for nucleic acid amplification test (NAAT) assay to detect the presence of N. gonorrhoeae and chlamydia trachomatis at the Baseline visit. Only participants who had a pre-therapy N. gonorrhoeae isolate recovered from their urogenital specimen were evaluated. Microbiologically evaluable (ME) Population comprised of all randomized participants who had N. gonorrhoeae isolated from Baseline cultures of urogenital swab specimens, received any dose of gepotidacin, and returned for their TOC visit.|Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8)|ME Population|||Participants|||Number
1320203|NCT02294604|Secondary|Duration of Hand Washing|The secondary outcome is the duration of hand washing|Immediately||||Minute||Standard Error|Mean
1320204|NCT02294604|Secondary|Microorganisms on Hands After Surgery|The secondary outcomes is the colonies grown on bacterial culture plate|2 days after sampling||||colony forming unit||Standard Error|Mean
1320208|NCT02294474|Secondary|Percentage of Participants With Treatment-Emergent Anti-insulin Antibodies (AIAs)|Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were participants who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)|Analysis was performed on anti-insulin antibody population that included all participants from the safety population with at least one AIA sample available for analysis during the 6-months on-treatment period.|||percentage of participants|||Number
1320209|NCT02294474|Secondary|Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions|Percentage of participants with hypersensitivity reactions and injection site reactions were reported.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)|Analysis was performed on safety population.|||percentage of participants|||Number
1320210|NCT02294474|Secondary|Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)|Percentage of participants with at least one treatment emergent hypoglycemia reported at any time of the day were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)|Analysis was performed on safety population that included all participants randomized and exposed to at least 1 dose of investigational medicinal product (IMP) (SAR342434 or Humalog), regardless of the amount of treatment administered.|||percentage of participants|||Number
1320211|NCT02294474|Secondary|Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26|Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number analyzed in each row = participants with at least one post-baseline data during the 6-month period for specified categories.|||mmol/L||Standard Error|Least Squares Mean
1320212|NCT02294474|Secondary|Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26|The mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline mean 24-hour plasma glucose concentration assessment during 6-month study period.|||mmol/L||Standard Error|Least Squares Mean
1320213|NCT02294474|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline FPG assessment during the 6-months study period.|||mmol/L||Standard Error|Least Squares Mean
1320214|NCT02294474|Secondary|Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26|Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.|Week 26|Analysis was performed on ITT population.|||percentage of participants|||Number
1320215|NCT02294474|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, irrespective of compliance with the study protocol and procedures. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during the 6-month study period.|||percentage of HbA1c||Standard Error|Least Squares Mean
1320216|NCT02294461|Secondary|Number of Participants With Adverse Events|The Treatment-Emergent Adverse Events are defined as AEs with a possible or probable relationship to study drug. If participant was still on study drug at the analysis data cutoff date, then the length of the treatment-emergent period was calculated through the cutoff date.|From first dose of study drug up to data cut off date of 20 Sept 2015|Safety Analysis Set consisted of all randomized participants who received at least 1 dose of study drug.|||Participants|||Number
1320217|NCT02294461|Secondary|AUC From the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||μg·h/mL||Standard Deviation|Mean
1320218|NCT02294461|Secondary|Peak-Trough Ratio (PTR) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||Ratio||Standard Deviation|Mean
1320219|NCT02294461|Secondary|Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only)||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||L/h||Standard Error|Mean
1320220|NCT02294461|Secondary|Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2|N is the number of participants with available data at this time point.|From randomization up to data cutoff date of 20 Jan 2016; Day 2, 3, 8, 22, 29, 43, 57, 85, 86, 113, 141 and 169|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at least 1 time point.|||μg/mL||Standard Deviation|Mean
1320221|NCT02294461|Secondary|Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2|N is the number of participants with available data at this time point.|From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||μg/mL||Standard Deviation|Mean
1320222|NCT02294461|Secondary|AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point. Number of participants analyzed is the number of participants with available data at this time point.|||μg·h/mL||Standard Deviation|Mean
1320223|NCT02294461|Secondary|Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||μg/mL||Standard Deviation|Mean
1320224|NCT02294461|Secondary|Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||(h)||Full Range|Median
1320225|NCT02294461|Secondary|Best Overall Soft Tissue Response|Participants with measurable soft tissue disease at screening visit (i.e., at least one target lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) who have an objective response (complete response (CR) or partial response (PR)) during the study were included in the best overall soft tissue response assessment. The best overall soft tissue response was based on the investigator assessment using RECIST 1.1.|From randomization up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Participants|||Number
1320226|NCT02294461|Secondary|Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)|Best PSA response was defined as as ≥50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. Only participants who had both baseline and post-baseline assessments were included in the analysis.|Baseline up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Participants|||Number
1320227|NCT02294461|Secondary|Time to Initiation of Cytotoxic Chemotherapy|Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy. It included only therapies for prostate cancer. When multiple cytotoxic chemotherapies were initiated, the first chemotherapy was used to determine the time to event. Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of their last assessment indicating no evidence of cytotoxic chemotherapy usage.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 4.93 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
1320228|NCT02294461|Secondary|Time to First Skeletal-Related Event|Time to first skeletal-related event (SRE) was defined as the time from randomization to the first skeletal-related event, defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Participants who have not had a SRE at the time of the analysis were censored at their last assessment indicating no evidence of SRE.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 5.29 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
1320229|NCT02294461|Secondary|Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment|Duration of Radiographic Progression-free Survival (rPFS) was defined as the time from randomization to the rPFS event (deaths from any cause and radiographic disease progression). Radiographic disease progression is defined by RECIST 1.1 for soft tissue disease, or PCWG2 for bone lesions. If a participant met the criteria for more than 1 censoring rule, they were censored with the earliest censoring date. The radiographic progression date was the first date when progression definition was met, not confirmed.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo|Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
1320230|NCT02294461|Secondary|Duration of Overall Survival|Duration of overall survival was defined as the time from the randomization to deaths from any cause. For participants who were alive at the time of the data analysis, overall survival time was censored to the last know date the participants were known to be alive or data analysis cutoff date, whichever occurred first.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 8.02 months for enzalutamide and 5.55 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
1320231|NCT02294461|Primary|Time to Prostate-specific Antigen (PSA) Progression|The time to Prostate Specific Antigen (PSA) progression was defined as the time from randomization to the PSA progression. The PSA progression was defined according to the consensus guidelines of Prostate Cancer Clinical Trials Working Group 2 (PCWG2).For participants with PSA decline at Week 13, the PSA progression date was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which would be confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at Week 13, the PSA progression date was defined as the date when a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later. PSA progression at the time of the data analysis cutoff date could only be declared on or after week 13. Time to PSA progression was estimated using the Kaplan-Meier method. Participants without confirmed PSA progression were censored.|From randomization up to data cut off date of 20 Sept 2015; median follow-up time is 7.33 months for enzalutamide and 3.02 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
1320232|NCT02294019|Secondary|Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview.|Day1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.|||percentage of participants||95% Confidence Interval|Number
1320233|NCT02294019|Primary|Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.|Day 1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.|||percentage of participants||95% Confidence Interval|Number
1320234|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters|"Criteria for potentially clinically significant abnormalities:~Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Alkaline phosphatase: >1.5 ULN~Total bilirubin (TBILI): >1.5 ULN; >2 ULN~Conjugated bilirubin (CBILI): >1.5 ULN; >2 ULN~Unconjugated bilirubin: >1.5 ULN; >2 ULN~ALT and TBILI: ALT >3 ULN and TBILI >2 ULN~CBILI and TBILI: CBILI >35% TBILI and TBILI >1.5 ULN~Albumin: <=25 g/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
1320235|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters|"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromol/L; >=30% change from baseline; >=100% change from baseline~Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to < 60 mL/min; >=60 to <90 mL/min~Blood urea nitrogen: >=17 mmol/L~Uric acid: <120 micromol/L; >408 micromol/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
1320236|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes|"Criteria for potentially clinically significant abnormalities:~Sodium: <=129 mmol/L; >=160 mmol/L~Potassium: <3 mmol/L; >=5.5 mmol/L~Chloride: <80 mmol/L; >115 mmol/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
1320237|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters|"Criteria for potentially clinically significant abnormalities:~Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L unfasted or >=7 mmol/L fasted~Hemoglobin A1c (HbA1c): >8%~Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L~LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L~Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
1320246|NCT02293863|Secondary|Maximum Serum Concentration (Cmax ) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||mcg/mL||Standard Deviation|Mean
1320238|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters|"Criteria for potentially clinically significant abnormalities:~Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L~Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)~Red blood cells (RBC): >=6 Tera/L~Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L~White blood cells (WBC): <3.0 Giga/L (Non-Black[NB]) or <2.0 Giga/L (Black[B]); >=16.0 Giga/L~Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L~Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and < lower limit of normal (LLN); >4.0 Giga/L~Monocytes: >0.7 Giga/L~Basophils: >0.1 Giga/L~Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
1320239|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities|"Criteria for potentially clinically significant ECG abnormalities:~PR Interval: >200 millisecond (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%~QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%~QT Interval: >500 ms~QTc Bazett (QTc B): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms~QTc Fridericia (QTc F): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
1320240|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities|"Criteria for potentially clinically significant vital sign abnormalities:~Systolic blood pressure supine (SBP[S]): <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg~Diastolic blood pressure supine (DBP[S]): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg~Orthostatic systolic blood pressure (SBP[O]): <=-20 mmHg~Orthostatic diastolic blood pressure (DBP[O]): <=-10 mmHg~Heart rate supine (HR[S]): <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm~Weight: >=5% DFB; >=5% IFB"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
1320241|NCT02293902|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58) were considered treatment-emergent.|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population which included all randomized participants who actually received at least one dose or a partial dose of IMP.|||participants|||Number
1320242|NCT02293902|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24|American College of Rheumatology (ACR) response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); Swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant’s assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician’s global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant’s assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.|Week 24|Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who received at least one dose of investigational medicinal product (IMP) and had an evaluable primary endpoint, irrespective of compliance with the study protocol and procedures.|||percentage of participants|||Number
1320243|NCT02293863|Secondary|Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||mL||Standard Deviation|Mean
1320244|NCT02293863|Secondary|Observed Clearance (CL-obs) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||mL/day||Standard Deviation|Mean
1320245|NCT02293863|Secondary|Elimination Half-Life (Terminal t1/2) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||day||Standard Deviation|Mean
1320476|NCT02289157|Secondary|Number of Patients in Labor Versus no Labor Prior to Cesarean Section|Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320247|NCT02293863|Secondary|Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A|AUC0-inf is reported as day*microgram/milliliter (day*mcg/mL).|30 minutes (min) before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|Pharmacokinetic (PK)−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||day*mcg/mL||Standard Deviation|Mean
1320248|NCT02293863|Secondary|Duration of Ventilation||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||days||80% Confidence Interval|Median
1320249|NCT02293863|Secondary|Percentage of Participants Readmitted to Hospital Due to Any Cause||Days 30 and 60|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
1320250|NCT02293863|Secondary|Percentage of Participants With Secondary Complications of Influenza|The following were considered secondary complications of influenza: pneumonia, including hospital-acquired pneumonia (HAP) and ventilation-acquired pneumonia (VAP), exacerbations of chronic lung disease, myocarditis, acute respiratory distress syndrome (ARDS), otitis media, or other related complications.|From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
1320251|NCT02293863|Secondary|Percentage of Participants Using Antibiotics for Respiratory Infections||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
1320252|NCT02293863|Secondary|Duration of Intensive Care Unit (ICU) Stay||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||days||80% Confidence Interval|Median
1320253|NCT02293863|Secondary|Duration of Hospitalization||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||days||80% Confidence Interval|Median
1320254|NCT02293863|Secondary|Duration of Viral Shedding|Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the duration of viral shedding.|Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||days||80% Confidence Interval|Median
1320255|NCT02293863|Secondary|Peak Influenza A Viral Load|Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the peak Influenza A viral load expressed as log10 vp/mL.|Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||log10 vp/mL||Standard Deviation|Mean
1320256|NCT02293863|Secondary|Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus|Influenza A viral load was measured by quantitative polymerase chain reaction (qPCR) in nasopharyngeal samples at multiple time points during the study. AUEC is the area under the viral load-time curve expressed as log10 (viral particles/milliliter x hour) = log10 (vp/mL x hour).|Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||log10 (vp/mL x hour).||Standard Deviation|Mean
1320257|NCT02293863|Secondary|Percentage of Participants Who Died Due to Any Cause||Days 14, 30 and 60|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
1320258|NCT02293863|Secondary|Percentage of Participants With Clinical Resolution of Abnormal Vital Signs|Description: Clinical resolution of abnormal vital signs was defined as meeting three out of five of the following criteria: 1. SpO2 ≥ 95% without supplemental O2; 2. Respiratory rate < 24 breaths per minute without supplemental O2; 3. Core temperature < 37.2 Celsius (C) immediately prior to receipt of any antipyretic drug, and at least 6-8 hours from the last dose of antipyretic or core temperature > 36 C in participants who are initially hypothermic; 4. Heart rate (HR) < 100 beats/minute; 5. Systolic blood pressure (SBP) >90 mmHg. Reported here is the percentage of participants who had clinical resolution of at least three out of five abnormal vital signs by the end of study.|From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
1320301|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
1320259|NCT02293863|Secondary|Percentage of Participants With Clinical Failure|Clinical failure after 24 hours post-infusion of study drug was defined as progression to increased O2 requirement defined by an increase in oxygen supplementation from low flow oxygen (i.e., 2−6 liters per minute [L/min]) to high flow oxygen (i.e., > 6 L/min) or from oxygen supplementation alone to any positive pressure ventilation (PPV) or extracorporeal membrane oxygenation (ECMO), progression to ICU, prolonged ventilation or O2 support defined by > 2 weeks, or death.|24 hours after end of infusion (infusion duration = approximately 120 minutes) up to Day 60|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
1320260|NCT02293863|Secondary|Percentage of Participants by Clinical Status Using a Categorical Ordinal Outcome|The clinical status of participants was defined by five mutually exclusive categories: 1. Death; 2. In the Intensive Care Unit (ICU); 3. Non-ICU hospitalization, requiring supplemental oxygen (O2); 4. Non-ICU hospitalization, not requiring supplemental oxygen (O2); 5. Not hospitalized.|Days 1-7, 14 and 30|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants|||Number
1320261|NCT02293863|Primary|Time to Normalization of Respiratory Function|The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.|From randomization up to 60 days|Intent-to-treat infected (ITTi) population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||days||80% Confidence Interval|Median
1320262|NCT02293863|Primary|Number of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A|Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.|From randomization up to 60 days|Safety Population included all randomized participants who received study drug, with participants grouped according to the treatment actually received. Here, number analyzed are the participants who were evaluable for this outcome measure.|||participants|||Number
1320263|NCT02293863|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From randomization up to 60 days|Safety Population included all randomized participants who received study drug, with participants grouped according to the treatment actually received.|||percentage of participants|||Number
1320264|NCT02293538|Secondary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 14, after 2 hours of lens wear|Intention to treat participants with non-missing observations|||ICU||Standard Deviation|Mean
1320265|NCT02293538|Secondary|Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations|||hours||Standard Deviation|Mean
1320266|NCT02293538|Secondary|Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses|Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations|||percentage of participants|||Number
1320267|NCT02293538|Secondary|Mean Comfortable Lens Wear Time (Time Uncomfortable – Time Insertion) at Baseline and Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations|||hours||Standard Deviation|Mean
1320268|NCT02293538|Primary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 1, after 2 hours of lens wear|Intention to treat participants with non-missing observations|||ICU||Standard Deviation|Mean
1320269|NCT02293395|Primary|Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events|Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of >=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - <5 g/dl (or drop in hematocrit of 9 - <15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.|From start of study treatment until follow-up (up to 390 days)|Population analyzed included all randomized participants who had received at least one dose of study agent and had events that occurred between randomization and the last dose of the study agent plus 2 days or untreated participants who had events that occurred between randomization to 2 days thereafter.|||participants|||Number
1320270|NCT02292849|Secondary|Changes in Hamilton Depression Rating Scale Scores|Hamilton Depression Rating Scale mean change scores from baseline to 12 weeks. This scale measures severity of depressive symptoms (range=0-76), with higher scores indicating more sever depressive symptomatology.|Baseline and 12 weeks|Randomized clients|||units on a scale||Standard Deviation|Mean
1320271|NCT02292849|Primary|Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions|Number of Peer to Peer clients who attend > 80% of Behavioral Activation sessions|12 weeks|Clients assigned to receive Peer BA|||Participants|||Count of Participants
1320272|NCT02292849|Primary|Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification|Proportion of Peer to Peer coaches who undergo Behavioral Activation training and achieve certification|4 weeks prior to Baseline|This outcome analyzed Peer to Peer coaches who were eligible to provide the Behavioral Activation intervention|||Participants|||Count of Participants
1320273|NCT02292719|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|Up to 12 weeks after the last actual dose of active study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
1320274|NCT02292719|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.|Up to Week 12|ITT population|||percentage of participants||95% Confidence Interval|Number
1320275|NCT02292719|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
1320276|NCT02292537|Secondary|Number of Participants Taking Any Concomitant Medication Related to Dosing Procedure or Sham Procedure|Concomitant medications include prescription and over-the-counter medications administered to participants on or after the first day of study treatment.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure.|||participants|||Number
1320277|NCT02292537|Secondary|Number of Participants With Abnormal, Clinically Relevant Post-Baseline Worsening in Electrocardiogram (ECG) in Results|The number of participants with abnormal, clinically relevant worsening, defined as participants with an ECG interpreted as abnormal and clinically relevant, with a comparison with Baseline value is reported.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure.|||participants|||Number
1320278|NCT02292537|Secondary|Number of Participants With Clinically Significant Laboratory Parameter Abnormalities|Laboratory parameter changes assessed for clinical significance include serum chemistry, hematology, coagulation and urinalysis.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening clinical laboratory parameter findings were reported as AEs and are presented in the AE/SAE section of the results.|||participants|||Number
1320279|NCT02292537|Secondary|Number of Participants With Clinically Significant Physical Examination Abnormalities|Physical examination changes were assessed for clinical significance.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Physical examination clinical significance was not collected.||||||
1320280|NCT02292537|Secondary|Number of Participants With Clinically Significant Neurological Examination Abnormalities|Neurological changes assessed for clinical significance include assessment of mental status, level of consciousness, sensory function, motor function, cranial nerve function, and reflexes.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Neurological examination clinical significance was not collected.||||||
1320281|NCT02292537|Secondary|Number of Participants With Clinically Significant Weight Abnormalities|Weight changes assessed from Baseline to Month 15.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening weight abnormality findings were reported as AEs and are presented in the AE/SAE section of the results.|||participants|||Number
1320282|NCT02292537|Secondary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital signs assessed for clinical significance include resting blood pressure, pulse, respiratory rate, and temperature.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening vital sign findings were reported as AEs and are presented in the AE/SAE section of the results.|||participants|||Number
1320477|NCT02289157|Secondary|Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section|Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320283|NCT02292537|Secondary|Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death; an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. All participants with AEs were reported in this outcome measure, whereas in Adverse Event section there was at 5% reporting threshold to be met.|||participants|||Number
1320284|NCT02292537|Secondary|Proportion of Participants That Achieved Walking With Assistance|If the participant was unable to achieve walking with assistance at baseline but could achieve this at Month 15 then they were considered a responder. If they could not achieve this or if a participant terminated the study prior to the 15-month assessment due to treatment failure or death, then any imputed value was ignored and the participant was considered as a non-responder.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||Proportion of participants||95% Confidence Interval|Number
1320285|NCT02292537|Secondary|Proportion of Participants That Achieved Standing Alone|If the participant was unable to achieve standing alone at Baseline but could achieve this at Month 15 then they were considered a responder. If they could not achieve this or if a participant terminated the study prior to the 15-month assessment due to treatment failure or death, then any imputed value was ignored and the participant was considered as a non-responder.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||Proportion of participants||95% Confidence Interval|Number
1320286|NCT02292537|Secondary|Change From Baseline in Revised Upper Limb Module (RULM) Test|The RULM Test is used in patients with SMA to assess upper limb functional ability items that are reflective of activities of daily living (i.e., raise a can to mouth as if drinking, take a coin and place it in a box, remove the lid of a container). The RULM test has a total of 20 items with an entry item that serves as functional class identification and does not contribute to the total score. The remaining 19 scorable items reflect different functional domains and are graded on a 3-point system with a score of 0 (unable), 1 (able, with modification), and a maximum of 2 (able, no difficulty). There is only 1 item (item I) that is scored as a can/cannot score, with 1 as the highest score. Scorable items are summed for a total score range of 0-37, with higher scores increased great upper limb function. A positive change from Baseline indicates improvement.|Baseline and Month 15|ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline data were imputed using multiple imputation.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1320287|NCT02292537|Secondary|Number of New Motor Milestones Achieved Per Participant|New motor milestones are defined as sitting without support, hands-and-knees crawling, standing with assistance, walking with assistance, standing alone and walking alone.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||milestones achieved||Standard Deviation|Mean
1320288|NCT02292537|Secondary|Proportion of Participants That Achieved Any New Motor Milestone at Month 15|New motor milestones are defined as sitting without support, hands-and-knees crawling, standing with assistance, walking with assistance, standing alone and walking alone.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||Proportion of participants||95% Confidence Interval|Number
1320289|NCT02292537|Secondary|Proportion of Participants Who Achieved a 3-Point Increase From Baseline in HFMSE Score at Month 15|The HFMSE consists of 33 scored activities used to assess motor function in children with SMA. The scale was originally developed with 20 scored activities and was devised for use in children with SMA Type 2 and Type 3 with limited ambulation to give objective information on motor ability and clinical progression. The expanded scale includes an additional module of 13 items developed to allow for evaluation of ambulatory SMA patients. Participants were asked to do a specific activity (such as rolling) and they were then graded on the quality and execution of that movement on a scale of 0=being unable, 1=performed with some compensation, and 2=unaided. The overall score is the sum of the scores for all activities with a maximum achievable score of 66. Higher scores indicate increased motor function. A positive change from Baseline indicates improvement.|Baseline and Month 15|ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline HFMSE data were imputed using multiple imputation.|||Proportion of participants||95% Confidence Interval|Number
1320290|NCT02292537|Primary|Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15|The HFMSE consists of 33 scored activities used to assess motor function in children with SMA. The scale was originally developed with 20 scored activities and was devised for use in children with SMA Type 2 and Type 3 with limited ambulation to give objective information on motor ability and clinical progression. The expanded scale includes an additional module of 13 items developed to allow for evaluation of ambulatory SMA patients. Participants were asked to do a specific activity (such as rolling) and they were then graded on the quality and execution of that movement on a scale of 0=being unable, 1=performed with some compensation, and 2=unaided. The overall score is the sum of the scores for all activities with a maximum achievable score of 66. Higher scores indicate increased motor function. A positive change from Baseline indicates improvement.|Baseline and Month 15|ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline HFMSE data were imputed using the multiple imputation method.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1320291|NCT02292433|Secondary|Change From Baseline in Pre-Meal C-Peptide at Day 7|Time-matched change from baseline in pre-meal serum C-peptide on Day 7 of each period was analyzed. Pre-meal C-peptide levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||ng/mL||Standard Deviation|Mean
1320292|NCT02292433|Secondary|Change From Baseline in Pre-Meal Insulin at Day 7|Time-matched change from baseline in pre-meal serum insulin on Day 7 of each period was analyzed. Pre-meal insulin levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||micro international unit per milliliter||Standard Deviation|Mean
1320293|NCT02292433|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment|FPG was defined as plasma glucose measurements taken pre-breakfast, in the fasted state, and prior to dosing with study drug. Baseline was defined as the average of Hour 0 measurements taken on Day 0 and Day 1 in each intervention period. The measurement on the last day of treatment was defined as the average of Hour 0 measurements taken on Day 7 and Day 8 in each period.|Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||mg/dL||Standard Deviation|Mean
1320294|NCT02292433|Secondary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7|WMDG was defined as time-weighted mean daily glucose. WMDG was calculated by as the time-weighted mean of glucose levels at actual time points for glucose sampling, for Day 0 (Baseline) and Day 7.|Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7|The pharmacodynamic (PD) analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||mg/dL||Standard Deviation|Mean
1320295|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1320296|NCT02292433|Secondary|Accumulation Ratio (Rac) on Day 7 for PF-06455349|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1320297|NCT02292433|Secondary|Terminal Half-Life (t1/2) on Day 7 for PF-06455349|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) * 2/k el, where ‘k el’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||hour||Standard Deviation|Mean
1320298|NCT02292433|Secondary|Average Plasma Concentration (Cav) on Day 7 for PF­-06455349|Cav is the average plasma concentration during the 0 to 24 hour time period. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320299|NCT02292433|Secondary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF­-06455349|Ctrough is the concentration prior to study drug administration. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320300|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-­06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1320478|NCT02289157|Secondary|Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section|Cochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320302|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF­-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320303|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1320304|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF­-06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1320305|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
1320306|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320307|NCT02292433|Primary|Accumulation Ratio (Rac) on Day 7 for PF-04937319|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1320308|NCT02292433|Primary|Apparent Volume of Distribution on Day 7 for PF-04937319|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||liter||Geometric Coefficient of Variation|Geometric Mean
1320309|NCT02292433|Primary|Terminal Half-Life (t1/2) on Day 7 for PF-04937319|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where ‘k el’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Standard Deviation|Mean
1320310|NCT02292433|Primary|Apparent Oral Clearance on Day 7 for PF-04937319|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1320311|NCT02292433|Primary|Average Plasma Concentration (Cav) on Day 7 for PF-04937319|Cav is the average plasma concentration during the 0 to 24 hour time period.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320312|NCT02292433|Primary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319|Ctrough is the concentration prior to study drug administration.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320479|NCT02289157|Secondary|Number of Participants With Scheduled and Unscheduled Cesarean Section|Cochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320313|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1320314|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
1320315|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320316|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1320317|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
1320318|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|Pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1320319|NCT02292433|Primary|Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.|||participants|||Number
1320320|NCT02292433|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.|||participants|||Number
1320321|NCT02292212|Secondary|Device Malfunctions||Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)|The safety analysis population (SAA) that is comprised of all patients that received at least one session with the ViE-21|||malfunctions|||Number
1320322|NCT02292212|Primary|Activated Complement Factor III (C3a )|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. C3a was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of C3a level||Standard Deviation|Mean
1320323|NCT02292212|Primary|Platelet|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. Platelet count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of platelet level||Standard Deviation|Mean
1320324|NCT02292212|Primary|White Blood Cell (WBC)|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. WBC count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of WBC level||Standard Deviation|Mean
1320360|NCT02291549|Secondary|Decreased Sense of Smell Score|Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1320325|NCT02292212|Primary|Ultrafiltration Coefficient (KUF)|The KUF is important for regulating the rate and amount of fluid flow across the dialyzer membrane. It is calculated by dividing ultrafiltration rate with the transmembrane pressure (TMP). More specifically, transmembrane pressures were recorded at 10, 20, 30, 40 and 50 minutes after the initiation of the dialysis session with adjustment of the ultrafiltration rate at 0, 600, 1000, 1400 and 1800 mL/hr respectively. These determinations were made during the 2nd or 3rd treatment session during the 1st or 2nd week for control dialyzer (Pre-ViE phase), and for ViE-21 during week 3-8 and week 9-14 (ViE phase).|Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||mL/(hr*mmHg)||Standard Deviation|Mean
1320326|NCT02292212|Primary|Removal Rate of Beta-2-microglobulin (B2-MG)|"In order to calculate removal rate for B2-MG by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation.~Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100.~The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of B2MG removal||Standard Deviation|Mean
1320327|NCT02292212|Primary|Removal Rate of Albumin|"In order to calculate removal rate for albumin by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with hematocrit (HCT) at pre (HCTpre) and post (HCTpost).~Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100.~The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. The negative removal rate means the increase of serum concentration of albumin from pre to post dialysis session."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of albumin removal||Standard Deviation|Mean
1320328|NCT02292212|Primary|Removal Rate of Creatinine|"In order to calculate removal rate for creatinine by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation.~Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of creatinine removal||Standard Deviation|Mean
1320329|NCT02292212|Primary|Removal Rate of Urea|"In order to calculate removal rate for urea by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with Pre-dialysis concentration (Cpre) and Post-dialysis concentration (Cpost) of urea.~Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of urea removal||Standard Deviation|Mean
1320330|NCT02292186|Secondary|6-minute Walk Test Performance|Distance in meters walked in 6 minutes|Baseline, Month 6, and Month 12|Number of participants analyzed differs from baseline to 6 and 12 months due to study discontinuations|||meters||Standard Deviation|Mean
1320331|NCT02292186|Secondary|Clinical Effects of Long-term Dosing of ALN-TTRSC on Hospitalization|Hospitalization events were adjudicated by an independent committee as cardiovascular (CV) or non-CV events|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months||||Participants|||Count of Participants
1320332|NCT02292186|Secondary|Mortality|Total number of deaths in the study and total number of deaths adjudicated as being related to cardiovascular causes. Deaths were adjudicated by an independent adjudication committee as cardiovascular (CV) or non-CV events.|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months||||Participants|||Count of Participants
1320333|NCT02292186|Primary|Serum TTR Levels|Pharmacodynamic (PD) effect of long-term dosing of ALN-TTRSC on serum levels of TTR|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months|Long term samples not collected due to study termination; no data to analyze||||||
1320334|NCT02292186|Primary|Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.|The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study [drug] discontinuation.|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months||||Participants|||Count of Participants
1320335|NCT02291861|Secondary|Participants With Adverse Events During the Overall Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|The Safety Population was a subset of randomized participants and included all patients who were administered study drug (N=293).|||Participants|||Count of Participants
1320361|NCT02291549|Secondary|Nasal Obstruction/Congestion Score|Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms.|Day 90|Intent-to-treat population. Scoring for >=4 of 7 days immediately preceding the baseline and Day 90 visits was required. There were 34 (11.3%) participants with missing scores: 23 treatment and 10 control at Day 90 and 1 (treatment) at baseline. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1320336|NCT02291861|Secondary|Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points|"AIMS is an assessment tool used to detect and follow the severity of TD over time, composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.~Participants with missing data are classified as non-responders. The responder 95% CI is calculated with the Wilson (score) confidence limits. If any of the expected cell counts are < 5, exact Clopper Pearson limits are presented.~Data report the percentage of participants who responded to the percentage improvement indicated in each row."|Day 0 (Baseline), Week 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment.|||percentage of participants||95% Confidence Interval|Number
1320337|NCT02291861|Secondary|Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)|"AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.~MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure."|Day 0 (Baseline), Weeks 2, 4, 8 and 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included.|||percentage of baseline||Standard Error|Least Squares Mean
1320338|NCT02291861|Secondary|Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12|"Responders who had a 50% or greater improvement in total motor modified AIMS at Week 12 as compared to baseline were reported as a percentage of participants with an outcome at Week 12. The responder 95% CI is calculated with the Wilson (score) confidence limits.~AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement."|Day 0 (Baseline), Week 12|mITT population of participants. Participants with missing Week 12 data were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1320339|NCT02291861|Secondary|Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)|"The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (–3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as “much improved” or “very much improved” at the week 12 visit.~Patients whose status at week 12 was not known, as well as patients who were not “much improved” or~“very much improved” at the week 12 visit, were considered treatment failures. The success 95% CI was calculated with the Wilson (score) confidence limits."|Week 12|mITT population|||percentage of participants||95% Confidence Interval|Number
1320340|NCT02291861|Secondary|Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12|"The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life.~The following domains are evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 – 96. Negative change from baseline scores indicate improvement.~For patients with missing data at week 12, the baseline or last available value was used as the week 12 value."|Day 0 (Baseline), Week 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. One SD-809 12 mg/day participant was missing a baseline mCDQ-24.|||units on a scale||Standard Error|Least Squares Mean
1320341|NCT02291861|Secondary|Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)|"The CGIC is a single-item questionnaire that asks the investigator to assess a patient’s TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (–3) to very much improved (+3), to assess overall response to therapy.~A treatment success was defined as “much improved” or “very much improved” at the week 12 visit.~Patients whose status at week 12 was not known, as well as patients who were not “much improved” or “very much improved” at the week 12 visit, were considered treatment failures.~The success 95% confidence interval (CI) was calculated with the Wilson (score) confidence limits."|Week 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment.|||percentage of participants||95% Confidence Interval|Number
1320480|NCT02289157|Secondary|Number of Participants With Morbid Outcomes After Delivery||Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320342|NCT02291861|Primary|Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)|"AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.~MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure."|Day 0 (Baseline), Weeks 2, 4, 8 and 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included.|||units on a scale||Standard Error|Least Squares Mean
1320343|NCT02291718|Secondary|Variation in Contrast for the Entire Vascular System (coV)|The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.|30 minutes||||unitless||Standard Deviation|Mean
1320344|NCT02291718|Secondary|Hounsfield Unit Attenuation Values|Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.|30 minutes||||Hounsfield units||Standard Deviation|Mean
1320345|NCT02291718|Secondary|Signal to Noise Ratio|Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta.|30 minutes|Hiatus region of each subject group|||Signal-to-Noise Ratio||Standard Deviation|Mean
1320346|NCT02291718|Primary|Radiation Dose||30 minutes||||mSv||Standard Deviation|Mean
1320347|NCT02291679|Other Pre-specified|Percentage of 12-Week CSBM Overall Sustained Responders|"A 12-week CSBM Overall Sustained Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period, including ≥ 3 of the last 4 weeks. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
1320348|NCT02291679|Secondary|Change From Baseline in 12-Week Abdominal Discomfort|Abdominal discomfort was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal discomfort score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal discomfort scores reported during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
1320349|NCT02291679|Secondary|Change From Baseline in 12-Week Abdominal Bloating|Abdominal bloating was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal bloating score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal bloating scores reported during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
1320350|NCT02291679|Secondary|Percentage of Month 3 CSBM Responders|"A Month 3 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 3 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 3|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
1320351|NCT02291679|Secondary|Percentage of Month 2 CSBM Responders|"A Month 2 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 2 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 2|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
1320481|NCT02289157|Secondary|Number of Patients With Number of Clinic Visits|Number of clinic visits made by patients after surgery concerning wound morbidity per patient|Day of surgery to 30 days postoperative||||participants|||Number
1320352|NCT02291679|Secondary|Percentage of Month 1 CSBM Responders|"A Month 1 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 1 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 1|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
1320353|NCT02291679|Secondary|Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)|"A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥4 IVRS calls for the specified week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Participants in the Intent-to-Treat Population who reported >1 SBM/week during the Pretreatment Period (14 days prior to randomization). Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
1320354|NCT02291679|Secondary|Change From Baseline in 12-Week Straining Score|Straining was measured daily using a 5-point ordinal scale (1 = not at all; 2 = a little bit; 3 = a moderate amount; 4 = a great deal; 5 = an extreme amount). The participant's straining score for the Treatment Period is the average of the non-missing straining scores from the SBMs reported by the participant during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
1320355|NCT02291679|Secondary|Change From Baseline in 12-Week Stool Consistency Score|Stool consistency was measured daily using the 7-point ordinal Bristol Stool Form Scale (BSFS; 1 = separate hard lumps like nuts [difficult to pass]; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges [passed easily]; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces [entirely liquid]). The participant's BSFS score for the Treatment Period is the average of the non-missing BSFS scores from the SBMs reported by the participant during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
1320356|NCT02291679|Secondary|Change From Baseline in 12-Week SBM Frequency Rate|A participant's 12-week SBM Frequency Rate is the SBM rate (SBMs/week) calculated over the 12-weeks of the Treatment Period. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||SBMs/week||Standard Error|Least Squares Mean
1320357|NCT02291679|Secondary|Change From Baseline in 12-Week CSBM Frequency Rate|A participant's 12-week CSBM Frequency Rate is the CSBM rate (CSBMs/week) calculated over the 12 weeks of the Treatment Period. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||CSBMs/week||Standard Error|Least Squares Mean
1320358|NCT02291679|Primary|Percentage of 12-Week CSBM Overall Responders|"A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a bowel movement BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a primary endpoint; per protocol, data for the 145 μg dose arm were not collected for any pre-specified primary or secondary outcome measures.|||percentage of participants|||Number
1320359|NCT02291549|Secondary|Facial Pain/Pressure Score|Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values: 3 at baseline (1 treatment, 1 control)) and 2 at Day 90 (1 treatment, 1 control) No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1320407|NCT02289963|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.|||percent change||Standard Deviation|Least Squares Mean
1320362|NCT02291549|Secondary|Ethmoid Sinus Obstruction|Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline indicated reduction (improvement) in ethmoid sinus obstruction.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1320363|NCT02291549|Secondary|Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)|Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade >= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy.|Day 90|Intent-to-treat population, consisting of all patients in whom an implant or sham procedure was attempted. 2 participants did not complete Day 90 visit. No imputation of missing values was performed.|||Participants|||Count of Participants
1320364|NCT02291549|Primary|Bilateral Polyp Grade|Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1320365|NCT02291549|Primary|Nasal Obstruction/Congestion Score|Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.|Day 30|Intent-to-treat population. Scoring for >=4 days in 7 days before the baseline and Day 30 visits was required. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 4 (1.3%) participants (2 treatment, 2 control) with missing values at Day 30. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1320366|NCT02291510|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the first dose of study medication administration (0 h) to the time of the last quantifiable concentration following dose administration. Doses were administered 1 min prior to 0 h (standardized dinner) for qPM and BID dosing and 1 min prior to 12 h (standardized breakfast) for qAM and BID dosing.|Time points to create Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng/mL||Standard Error|Mean
1320367|NCT02291510|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration after the standardized dinner. Doses were administered 1 min prior to 0 h (standardized dinner) for once daily in the evening (qPM) and twice daily (BID) dosing and 1 min prior to 12 h (standardized breakfast) for once daily in the morning (qAM) and BID dosing.|Time points to create AUC (0-t) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng*h/mL||Standard Error|Mean
1320368|NCT02291419|Other Pre-specified|The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions||up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
1320369|NCT02291419|Secondary|Non-fatal Stroke|Time to first occurence of Non-fatal stroke. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
1320370|NCT02291419|Secondary|All-cause Death|Time to first occurence of All-cause death. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
1320371|NCT02291419|Secondary|Non-fatal Myocardial Infarction or Coronary Revascularization|Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
1320372|NCT02291419|Secondary|Cardiovascular Death|Time to first occurence of Cardiovascular death. The number of patients with events was reported.|Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
1320373|NCT02291419|Primary|Major Adverse Cardiovascular Events|Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
1320374|NCT02291237|Secondary|Change in Treadmill Exercise Time From Baseline to Week 12|Treadmill exercise time is the time to peak exercise.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||min||Standard Deviation|Mean
1320375|NCT02291237|Secondary|Change in Treadmill Exercise Time From Baseline to Week 24|Treadmill exercise time is the time to peak exercise.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||min||Standard Deviation|Mean
1320408|NCT02289963|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1320376|NCT02291237|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12|The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||Score||Standard Deviation|Mean
1320377|NCT02291237|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24|The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||Score||Standard Deviation|Mean
1320378|NCT02291237|Secondary|Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||mL/kg/min||Standard Deviation|Mean
1320379|NCT02291237|Primary|Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24||Baseline to Week 24|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed.|||mL/kg/min||Standard Deviation|Mean
1320380|NCT02290821|Primary|Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)|The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed.|24 hours||||units on a scale||Standard Deviation|Mean
1320381|NCT02290691|Secondary|Percentage of Subjects With Spontaneously Reported Adverse Events|"Subjects will be asked to report any other symptoms experienced in addition to the solicited immediate and vaccine reactogenicity events. Any other events reported will be tabulated as spontaneously reported adverse events."|28 days||||percentage of subjects|||Number
1320382|NCT02290691|Secondary|Percentage of Subjects With Solicited Local or Systemic Adverse Events|vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site pain, injection site tenderness, injection site itching, injection site swelling, injection site redness, injection site bruising, fever, fatigue, headache, nausea, chills, muscle ache.|7 Days|Data included in the analysis were collected on a 7-Day Diary Card from the safety population and grade >1.|||percentage of subjects|||Number
1320383|NCT02290691|Secondary|Percentage of Subjects With Immediate Complaints|"The following possible immediate complaints will be solicited following the 30 minute safety observation period post-vaccination: local pain, redness, induration/swelling, itching where the injection was given. The data will be reported as immediate complaints and presumed to be related to the test article. Any other symptom experienced at 30 minutes will be recorded as an adverse event."|Day 0||||percentage of participants|||Number
1320384|NCT02290691|Primary|The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 Days|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Immunogenicity Population.|||participants|||Number
1320385|NCT02290691|Primary|Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.|28 Days|Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the immunogenicity population.|||Titers||Standard Deviation|Geometric Mean
1320386|NCT02290509|Primary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.|Day 0 and Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.|||titer||95% Confidence Interval|Geometric Mean
1320387|NCT02290509|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)||Six months post-vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.|||participants|||Number
1320388|NCT02290509|Secondary|Number of Participants With Systemic and Injection Site Reactogenicity||Days 0-7|The Reactogenicity Population includes subjects who recorded any systemic reaction data and injection site reaction data following administration of study vaccine. This was two subjects less than the Safety Population.|||participants|||Number
1320409|NCT02289963|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Deviation|Least Squares Mean
1320389|NCT02290509|Primary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.|||percentage of participants||95% Confidence Interval|Number
1320390|NCT02289989|Secondary|Rate Skin Tolerance of Topical Agents|The patient or caregiver rated how well the patient tolerated the product after applying it on day 7 and 14. The scale was excellent, good, moderate and poor.|On day 7 and 14||||participants|||Number
1320391|NCT02289989|Secondary|Rate Cosmetic Acceptability of Topical Agents|The patient or caregiver rated how the product felt on their skin after applying the product, measuring the cosmetic acceptability on day 7 and 14. The scale was excellent, good, moderate and poor.|On day 7 and 14||||participants|||Number
1320392|NCT02289989|Secondary|Measure Presence of S. Aureus Colonization on Affected Skin|Bacterial culture of the affected area was done on day 0 and day 14.|Baseline to day 14||||participants|||Number
1320393|NCT02289989|Primary|Histological Improvement Measured by Confocal Microscopy|Confocal microscopy was done to the patient on day 0, day 14 and day 28. Due to technical difficulties, this outcome measure was not collected.|Baseline to day 28|Data not collected||||||
1320394|NCT02289989|Primary|Change of the Clinical Efficacy Rated by a Study Physician|Physician was asked to grade four characteristics: erythema, infiltration/papulation, excoriation and lichenification. The grade was none (0), mild (1), moderate (2) and severe (3).|Baseline to day 28||||participants|||Number
1320395|NCT02289989|Primary|The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25|"This was measured with two questions. The first one referred to the description of the lesion and it included six characteristics: clear, dry, scaly, redness, cracks/opening and oozing. The second questions asked to grade how itchy was the patient.~All characteristics were measured on a scale from 0 to 5 (0 none, 5 extremely bothered/losing sleep)."|From baseline to day 25||||participants|||Number
1320396|NCT02289963|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1320397|NCT02289963|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1320398|NCT02289963|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1320399|NCT02289963|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1320400|NCT02289963|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
1320401|NCT02289963|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1320402|NCT02289963|Secondary|Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1320403|NCT02289963|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1320404|NCT02289963|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percentage of participants|||Number
1320405|NCT02289963|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percentage of participants|||Number
1320406|NCT02289963|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1320410|NCT02289963|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Deviation|Least Squares Mean
1320411|NCT02289963|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1320412|NCT02289963|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
1320413|NCT02289963|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1320414|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
1320415|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1320416|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||Percent Change||Standard Error|Least Squares Mean
1320417|NCT02289963|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1320418|NCT02289898|Primary|Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms|Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.|Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).|Placebo/placebo arm and pooled demcizumab arms (ITT population).|||Participants|||Count of Participants
1320419|NCT02289833|Secondary|Serum Concentration of HER2 Extracellular Domain (ECD)||Pre-dose (within 2 days) on Day 1|Data were not collected for this outcome measure.||||||
1320420|NCT02289833|Secondary|Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)|The presence of ADAs in blood serum is an indication of the body's immune response to a drug.|Pre-dose (within 2 days) on Day 1 of Cycles 1 and 3; at treatment discontinuation/early termination, up to the clinical cutoff date (approximately 22 months)|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants with post-dose sample available for ADA analysis.|||percentage of participants|||Number
1320421|NCT02289833|Secondary|Maximum Observed Concentration (Cmax) for N2'- Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1)|Cmax is the maximum observed concentration of a drug and was measured in blood plasma.|Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycle 1 (one cycle=21 days); at treatment discontinuation/early termination, up to the clinical cutoff date (approximately 22 months)|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1320422|NCT02289833|Secondary|Clearance (CL) for Trastuzumab Emtansine and Total Trastuzumab|CL is a measure of the body’s elimination of a drug from blood serum over time.|Pre-dose and 30 minutes (min) post-infusion (inf.) on Day 1 of Cycles 1 and 3; post- inf. on Days 2, 3, 4 or 5, 8, and 15 of Cycle 1, and pre- inf. on Day 1 of Cycle 2 and Day 1 of Cycle 4 (cycle=21 days); discontin./termination, up to approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||mL/day/kg||Standard Deviation|Mean
1320443|NCT02289820|Secondary|Percentage of Participants With Post-dose Seroresponse to RSV by RSV A Microneutralization Assay|Seroresponse defined as a greater than or equal to (>=) 3-fold rise in titer from baseline. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.|Day 29|Immunogenicity population.|||Percentage of Participants||95% Confidence Interval|Number
1320423|NCT02289833|Secondary|Volume of Distribution (Vss) for Trastuzumab Emtansine and Total Trastuzumab|Vss is the volume of distribution of study drug at steady state.|Pre-dose and 30 minutes (min) post-infusion (inf.) on Day 1 of Cycles 1 and 3; post- inf. on Days 2, 3, 4 or 5, 8, and 15 of Cycle 1, and pre- inf. on Day 1 of Cycle 2 and Day 1 of Cycle 4 (cycle=21 days); discontin./termination, up to approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||milliliters kilogram (mL/kg)||Standard Deviation|Mean
1320424|NCT02289833|Secondary|Elimination Half-Life (t1/2) for Trastuzumab Emtansine and Total Trastuzumab|t1/2 is the time required for the drug serum concentration to be reduced to half.|Pre-dose and 30 minutes (min) post-infusion (inf.) on Day 1 of Cycles 1 and 3; post- inf. on Days 2, 3, 4 or 5, 8, and 15 of Cycle 1, and pre- inf. on Day 1 of Cycle 2 and Day 1 of Cycle 4 (cycle=21 days); discontin./termination, up to approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||days||Standard Deviation|Mean
1320425|NCT02289833|Secondary|AUCinf for Trastuzumab Emtansine and Total Trastuzumab|AUC (from zero to infinity) represents the total drug exposure over time in blood serum.|Pre-dose and 30 minutes (min) post-infusion (inf.) on Day 1 of Cycles 1 and 3; post- inf. on Days 2, 3, 4 or 5, 8, and 15 of Cycle 1, and pre- inf. on Day 1 of Cycle 2 and Day 1 of Cycle 4 (cycle=21 days); discontin./termination, up to approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||days times ug/mL (day* ug/mL)||Standard Deviation|Mean
1320426|NCT02289833|Secondary|Maximum Observed Concentration (Cmax) for Trastuzumab Emtansine and Total Trastuzumab|Cmax is the maximum observed concentration of a drug and was measured in blood serum.|Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycles 1 and 3 (one cycle=21 days); at treatment discontinuation/early termination, up to the clinical cutoff date (approximately 22 months)|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants.|||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
1320427|NCT02289833|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, whether or not considered related to the study drug. A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.|From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 22 months)|The safety-evaluable population included participants who received at least one dose of study treatment.|||percentage of participants|||Number
1320428|NCT02289833|Secondary|Percentage of Participants With Clinical Benefit as Per Investigator Assessment According to RECIST, v1.1|Clinical benefit is defined as having a CR or PR or stable disease (using RECIST, v1.1) at 6 months. Participants with no post-baseline response assessment are considered as experiencing no clinical benefit. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum while in the study. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From Day 1 to PD or death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1320429|NCT02289833|Secondary|Duration of Objective Response (DOR) Assessed According to RECIST v1.1|DoR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From first documented objective response to PD or death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with response.|||months||95% Confidence Interval|Median
1320430|NCT02289833|Secondary|Percentage of Participants With DOR Event of Disease Progression, Assessed According to RECIST v1.1|DOR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From first documented objective response to PD or death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with response.|||percentage of participants|||Number
1323315|NCT02226198|Secondary|TC (mg/dL)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
1320431|NCT02289833|Secondary|Progression-Free Survival (PFS) as Per Investigator Assessment According to RECIST v. 1.1|PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From Day 1 to PD or death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events.|||months||95% Confidence Interval|Median
1320432|NCT02289833|Secondary|Percentage of Participants With PFS Event of Disease Progression, as Per Investigator Assessment According to RECIST v. 1.1, or Death|PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From Day 1 to PD or death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug.|||percentage of participants|||Number
1320433|NCT02289833|Secondary|Overall Survival (OS)|OS is defined as the time from first study drug administration to death from any cause.|From Day 1 to death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events.|||months||95% Confidence Interval|Median
1320434|NCT02289833|Secondary|Percentage of Participants Who Died||From Day 1 to death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events.|||percentage of participants|||Number
1320435|NCT02289833|Primary|Percentage of Participants With Objective Response as Per Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v. 1.1)|Objective response is defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments ≥ 4 weeks apart, based on investigator assessment according to RECIST, Version 1.1. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Day 1 to disease progression (PD) or death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1320436|NCT02289820|Secondary|Percentage of Participants With Post-dose Cell-mediated Immune Response to RSV F by RSV F Peptide Pool IFNγ ELISPOT|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. The Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.|Day 8|Immunogenicity Population.|||Percentage of Participants||95% Confidence Interval|Number
1320437|NCT02289820|Secondary|GMFRs of Cellular Immune Response Against RSV by RSV F IFNγ ELISPOT Assay|The GMFRs assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples|Day 8|Immunogenicity Population.|||Fold rise||95% Confidence Interval|Geometric Mean
1320438|NCT02289820|Secondary|Geometric Mean Counts of Cellular Immune Response Against RSV by Respiratory Syncytial Virus Fusion Protein (RSV F) Interferon Gamma (IFNγ) Enzyme-linked Immunosorbent Spot (ELISPOT) Assay|The Geometric Mean Counts assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.|Baseline (Day 1) and Day 8|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||Spot forming counts per 10^6 PBMCs||95% Confidence Interval|Geometric Mean
1320439|NCT02289820|Secondary|Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies|The ratio of post-dose HAI antibody GMTs and GMFRs in the IIV group and the MEDI7510 plus IIV group was provided by strain and by cohort for Cohorts 2 and 3 to check the effect of MEDI7510 on IIV when administered together. Humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed on Day 29 by each strain (H1N1, H3N2, B/Yamagata).|Day 29|Immunogenicity Population.|||Ratio||95% Confidence Interval|Number
1320440|NCT02289820|Secondary|Percentage of Participants With Post-dose Seroresponse to RSV by Anti-F IgG Assay|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. Humoral immunity against RSV was assessed by an Anti-F IgG assay derived from the RSV-specific 4-plex MSD assay.|Day 29|Immunogenicity population.|||Percentage of Participants||95% Confidence Interval|Number
1320441|NCT02289820|Secondary|GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay|The Anti F IgG antibodies were derived from the RSV-specific 4-plex MSD assay developed on the Meso Scale discovery platform. Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.|Day 29, 61, 91, 181, 271, and 361|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||Fold rise||95% Confidence Interval|Geometric Mean
1320442|NCT02289820|Secondary|Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay|Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.|Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||F Ab Unit/mL||95% Confidence Interval|Geometric Mean
1320444|NCT02289820|Secondary|Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay|GMFRs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay from Baseline line through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.|Day 29, 61, 91, 181, 271, and 361|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||Fold rise||95% Confidence Interval|Geometric Mean
1320445|NCT02289820|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|GMTs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay at Baseline and the results through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A. Immunogenicity population is defined as all participants in ATP who had no protocol deviation judged to have the potential to interfere with generation or interpretation of an immune response.|Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361|Immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
1320446|NCT02289820|Primary|Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)|An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through the day of the last participant contact (Day 361 visit).|From Day 1 to Day 361|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
1320447|NCT02289820|Primary|Percentage of Participants With New Onset Chronic Diseases (NOCDs)|A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. All NOCDs were recorded from the time of dosing through the day of the last participant contact (Day 361 visit).|From Day 1 to Day 361|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
1320448|NCT02289820|Primary|Percentage of Participants With Treatment-emergent Serious Adverse Events|A serious adverse event (SAE) was an AE resulting in any of following reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk), persistent or significant disability/incapacity, congenital anomaly, and a medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|From Day 1 to Day 361|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
1320449|NCT02289820|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent were the events between administration of study drug and including the follow-up period through Day 29. The AEs were summarized using the Medical Dictionary for Regulatory Activities version 18.1.|From Day 1 to Day 29|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
1320450|NCT02289820|Primary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to [>=] 100.4°F [>=38°C] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The percentage of participants with solicited symptoms were recorded during Days 1 (day of dosing) through 7.|Day 1 to Day 7|As-treated Population (ATP) included all participants who received any amount of study drug.|||Percentage of Participants|||Number
1320451|NCT02289755|Secondary|Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion|Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%|7 days|All Participants (N=16) were included in the analysis.|||percentage change||Standard Deviation|Mean
1320452|NCT02289755|Primary|Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion|Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).|7 days|All Participants (N=16) completed treatment and were included in the analysis population.|||mg/day||Standard Deviation|Mean
1320453|NCT02289742|Secondary|Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 8, each product|This analysis population includes all randomized and exposed subjects with data at visit.|||percentage of subjects|||Number
1320454|NCT02289742|Primary|Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 12, each product|This analysis population includes all randomized and exposed subjects with data at visit.|||percentage of subjects|||Number
1320475|NCT02289157|Secondary|Number of Patients With Hypertension Versus no Hypertension|Cochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320482|NCT02289157|Secondary|Number of Patients With Emergency Room Visits After Discharge|Number of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.|Day of surgery to 30 days postoperative||||Participants|||Count of Participants
1320455|NCT02289469|Secondary|Patient Understanding|"Assessment of patient understanding of their medication regimen using 4 questions:~I understand what medicines I am supposed to take.~I understand how much medicine I am supposed to take at a time.~I understand what time of day to take each of my medicines.~I understand what each of my medicines is for. Participants had the following response options: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Due to formatting restrictions on this site and the results being nearly identical for each question, only answers to question 1 are reported below."|1 week|A convenience sample of 50 intervention patients was contacted by phone approximately 1 week after Emergency Department discharge to rate their understanding of their medication regimen.|||Participants|||Count of Participants
1320456|NCT02289469|Primary|Number of Participants With Changes/Updates in Medication List|Participants for whom nurses made updates or corrections to the medication history in electronic health record|1 day||||Participants|||Count of Participants
1320457|NCT02289456|Other Pre-specified|Percentage of Protocol Dose|The percentage of protocol specified dose administered during the induction and monotherapy periods. Percentage of protocol dose = (dose intensity / protocol weekly dose) * 100%; the protocol weekly dose of nab-paclitaxel is 66.67 mg/m2/week; the protocol weekly dose of carboplatin was 1.67 mg*min/mL/week.|From Day 1 of study drug treatment to end of study drug treatment; up to clinical data cut-off date of 24 February 2017; ; maximum treatment duration was 14.1 months.|The Treated Population consisted of all participants who received at least 1 dose of investigational product.|||Percentage of Protocol Dose||Full Range|Median
1320458|NCT02289456|Secondary|Number of Participants With TEAEs During the Induction and Monotherapy Periods|Treatment-emergent adverse events were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|From date of the first dose of IP until 28 days after the last IP dose and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; up to cutoff date of 24 Feb 2017; maximum treatment duration was 14.1 months|The Treated Population consisted of all participants who received at least 1 dose of IP.|||Participants|||Count of Participants
1320459|NCT02289456|Secondary|Kaplan Meier Estimate of Duration of Response|Duration of overall response was measured from the time measurement criteria were first met for CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline), whichever was first recorded, until the first date that recurrent disease or PD (at least a 20% increase in the sum of diameters of target lesions from nadir) was radiologically documented (taking as reference for PD the smallest measurements recorded on study). Median and 95% CI were estimated based on the Kaplan-Meier method.|From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|Participants in the Treated population with a CR or PR. Participants who were non-responders (i.e., did not achieve at least a PR) were excluded from this analysis.|||Months||Full Range|Median
1320460|NCT02289456|Secondary|Time to Response|Time to response was defined as the time from Day 1 of study treatment to the first occurrence of response (CR or PR) according to RECIST v1.1 guidelines. RECIST V1.1 criteria includes: - A Complete Response (CR) is the disappearance of all target lesions; - A Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline|From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|Treated Population; participants with a CR or PR|||Months||Full Range|Median
1320461|NCT02289456|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines|Overall tumor response is defined as the percentage of participants who achieved an objective confirmed CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline) according to RECIST V1.1 guidelines, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on Day 1 of study treatment.|Response assessments were evaluated every 2 cycles; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|Participants who achieved a partial or complete response.|||Percentage of participants||95% Confidence Interval|Number
1320462|NCT02289456|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|From Day 1 of study treatment to death from any cause; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|The Treated population consisted of all participants who received at least 1 dose of Investigational Product.|||months||95% Confidence Interval|Median
1320463|NCT02289456|Secondary|Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate)|Disease control rate was defined as the percentage of participants who had continued stable disease, complete or partial response during the course of the study, according to RECIST v1.1 guidelines, as evaluated by the investigator. RECIST V1.1 criteria includes: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease; - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir|Response assessments were evaluated every 6 weeks; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|The Treated population consisted of all participants who received at least 1 dose of IP|||Percentage of Participants||95% Confidence Interval|Number
1320483|NCT02289157|Secondary|Length of Stay After Readmission|Number of days in hospital after readmission for wound morbidity|After dismissal and readmitted within 30 days for wound morbidity||||days||Inter-Quartile Range|Median
1320464|NCT02289456|Secondary|Kaplan Meier Estimate of Progression-Free Survival (PFS)|Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator’s assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir|From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|The treated Population consisted of all participants who received at least 1 dose of investigational product.|||months||95% Confidence Interval|Median
1320465|NCT02289456|Secondary|Percentage of Participants With Dose Reductions During the Entire Study|A dose reduction occurs when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities.|From day 1 of IP until 28 days after the last dose of IP; maximum treatment duration was 14.1 months during the entire study|The treated population consisted of all participants who received at least 1 dose of Investigational Product.|||Percentage of Participants|||Number
1320466|NCT02289456|Secondary|Dose Intensity of Carboplatin During the Entire Study|Dose intensity for carboplatin during the entire study period was (mg*min/mL/week) = [cumulative dose for carboplatin in mg*min/mL] / [carboplatin dosing period in weeks].|From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months|The treated population consisted of all participants who received at least 1 dose of investigational Product.|||mg*min/mL/week||Standard Deviation|Mean
1320467|NCT02289456|Secondary|Dose Intensity of Nab-Paclitaxel During the Entire Study|Dose intensity for nab-paclitaxel during the entire study period was (mg/m^2/week) = [cumulative dose for nab-paclitaxel in mg/m^2] / [nab-paclitaxel dosing period in weeks]|From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months|The treated population consisted of all participants who received at least 1 dose of Investigational Product.|||mg/m^2/week||Standard Deviation|Mean
1320468|NCT02289456|Secondary|Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate)|Discontinuation Rate was measured as Percentage of Participants who Discontinued Study Treatment During the Induction Period|From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months|The Treated population consisted of all participants who received at least 1 dose of Investigational Product.|||Percentage of Participants|||Number
1320469|NCT02289456|Primary|Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs).|Treatment-emergent adverse events were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. A participant met the primary endpoint if: an AE was the reason for discontinuation as recorded in the electronic Case Report Form (eCRF) and the participant had no doses administered beyond Cycle 4. 95% confidence interval for the percentage was calculated using the Clopper Pearson method.|From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months|The Treated population consisted of all participants who received at least 1 dose of Investigational Product.|||Percentage of Participants||95% Confidence Interval|Number
1320470|NCT02289222|Secondary|Time to Progression Free Survival (PFS)|PFS will be measured in all participants. Survival and PFS functions were estimated using the Kaplan-Meier method. The Cox regression model was used to assess the following plausible risk factors for OS and PFS: age, isotype, number of cycles of therapy, and cytogenetic profile.|PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.||||Months||95% Confidence Interval|Median
1320471|NCT02289222|Secondary|PD-LI Expression On Myeloma Cells|The identification of a biomarker for response by evaluating PD-1/PDL-1 expression in patients’ bone marrow aspirate samples will be analyzed in order to help select patients for future anti-PD-1 therapy. The main exploratory biomarker analysis was to examine potential correlation between expression of PD-1 on T cells and PD-L1 on myeloma cells with clinical outcome using the following parameters: response rate focusing on responses ≥ very good partial response (VGPR) and PFS. SAS software (v.9.4; SAS Institute, Inc, Cary, NC) was used for statistical analyses.|Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months)|Data were analyzed for 29 samples.|||Participants|||Count of Participants
1320472|NCT02289222|Primary|The Number of Participants With Adverse Events|Establish the safety and tolerability of Pomalidomide and Dexamethasone in combination with MK-3475|24 month||||Participants|||Count of Participants
1320473|NCT02289157|Secondary|Number of Patients With Chorioamnionitis Versus no Chorioamnionitis|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320474|NCT02289157|Secondary|Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes|Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320484|NCT02289157|Secondary|Length of Postoperative Stay|Number of Days in Hospital after Initial Surgery|Length of Postoperative Stay||||days||Inter-Quartile Range|Median
1320485|NCT02289157|Primary|Number of Participants With Classification of Wound Morbidity|Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
1320486|NCT02289157|Primary|Number of Participants With Wound Complication|Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.|Day of surgery to 30 days postoperative||||Participants|||Count of Participants
1320487|NCT02289105|Other Pre-specified|Participant Selections on ADs and Declination Forms||Baseline - up to 1 year|||||||
1320488|NCT02289105|Secondary|Proportion of Participants Who Return a Signed AD|This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.|Baseline - up to 1 year||||proportion of participants||95% Confidence Interval|Number
1320489|NCT02289105|Secondary|Proportion of Participants Who Already Have ADs||Baseline - up to 1 year||||proportion of participants|||Number
1320490|NCT02289105|Primary|Proportion of Participants That Select to Complete an Advance Directive|We will analyze the effects of the active choice intervention on rates of completion.|Baseline - up to 1 year||||proportion of participants||95% Confidence Interval|Number
1320491|NCT02289079|Secondary|Patient Satisfaction as Assessed Via Patient Survey|To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.|assessed at 72 hours after injection||||participants satisfied with pain control|||Number
1320492|NCT02289079|Secondary|Post Operative Length of Stay|To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block|up to 30 days after surgery||||Hours||Standard Deviation|Mean
1320493|NCT02289079|Secondary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours||||scores on a scale||Full Range|Median
1320494|NCT02289079|Primary|Post Operative Opioid Use|To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block|0-72 hours after injection||||micrograms of fentanyl equivalents||Full Range|Median
1320495|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting|Data not collected at this time point.||||||
1320496|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.||||||
1320497|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.||||||
1320498|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting|Data not collected at this time point.||||||
1320499|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to injection of “deep” anesthesia in the breast parenchyma, within approximately 4 minutes of starting|Data not collected at this time point.||||||
1320500|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting|Data not collected at this time point.||||||
1320501|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the biopsy, within approximately 20 minutes of starting||||units on a scale||Standard Deviation|Mean
1320502|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting||||units on a scale||Standard Deviation|Mean
1320503|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the skin, within approximately 1 minute of starting||||units on a scale||Standard Deviation|Mean
1320504|NCT02288364|Primary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to anesthetizing, within approximately 1 minute of starting||||units on a scale||Standard Deviation|Mean
1320505|NCT02288312|Secondary|AUC0-∞ (BIA 2-005)|AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||ng.h/mL||Standard Deviation|Mean
1320506|NCT02288312|Secondary|Tmax (BIA 2-005)|tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||hours||Standard Deviation|Mean
1320507|NCT02288312|Secondary|AUC0-t (BIA 2-005)|AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||ng.h/mL||Standard Deviation|Mean
1320508|NCT02288312|Primary|Cmax (BIA 2-005)|Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||ng/mL||Standard Deviation|Mean
1330830|NCT02091752|Secondary|Patient Global Impression of Change (PGIC) Score||Week 1, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1320515|NCT02288273|Primary|Change in 24-hour Mean Weighted Glucose|Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).|Day 27/28||||(mg/dL)|(mg/dL)|Standard Deviation|Mean
1320516|NCT02288091|Secondary|Blood Biomarkers (FRAP) at Baseline and Week 12|Blood samples will be obtained at baseline and after 12 weeks of treatment to measure biomarkers of oxidative stress and damage such as ferric reducing antioxidant power (FRAP).|12 weeks|One (1) subject did not have blood drawn for FRAP analysis at the Baseline Visit. Four (4) subjects did not have blood drawn for FRAP analysis at the Week 12 visit. These missing samples are due to technical issues, such as a difficult blood draw or issue with sample processing.|||µM||Standard Deviation|Mean
1320517|NCT02288091|Secondary|Neuroimaging Biomarkers at Baseline and Week 12|Magnetic resonance spectroscopy (MRS) will be performed to measure the levels of glutathione in the motor cortex; levels of glutathione at Week 12 (post-treatment) will be compared to pre-treatment levels.|12 weeks|Five (5) subjects did not have a MRS done at the Baseline and Week 12 visits. Of the 20 that had a baseline MRS, 2 patients did not have a Week 12 MRS done. These missing MRS scans are due to technical difficulties, such as subjects were unable to complete the scan.|||mM||Standard Deviation|Mean
1320518|NCT02288091|Secondary|Blood Biomarkers (GSH) at Baseline and Week 12|Blood samples will be obtained at baseline and after 12 weeks of treatment to measure biomarkers of oxidative stress and damage such as glutathione (GSH).|12 weeks|Two (2) subjects did not have blood drawn for GSH analysis at the Baseline Visit. Five (5) subjects did not have blood drawn for GSH analysis at the Week 12 visit. These missing samples are due to technical issues, such as a difficult blood draw or issue with sample processing.|||ƥM||Standard Deviation|Mean
1320519|NCT02288091|Primary|Tolerability to Complete the Entire 12 Week Study on Study Drug.|Tolerability will be defined as the ability of subjects to complete the entire 12-week study on study drug.|12 weeks|Twenty-four (24) out of twenty-five (25) participants completed 12 weeks of study drug treatment.|||Participants|||Count of Participants
1320520|NCT02288091|Primary|Number of Participants Experiencing Adverse Events|Safety will be assessed by the occurrence of adverse events.|12 weeks|No expected adverse events of special interest, such as kidney stones and gout, occurred during the course of the study. However, twenty-two (22) out of twenty-five (25) participants did experience an adverse event during the course of the study.|||Participants|||Count of Participants
1320521|NCT02287883|Primary|PHQ-4|Patient Reported Emotional Functioning, scale 1 (anxious or depressed nearly every day) -5 (not at all anxious or depressed). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).|1 year|Patients who completed a survey at both baseline and at one-year follow-up.|||units on a scale||Standard Deviation|Mean
1320522|NCT02287883|Primary|PROMIS Short Form 12a|Patient-Reported Physical Functioning, scale 1 (unable to do activity) -5 (no difficulty). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).|1 year|Patients completing a survey at both baseline (2015) and one-year follow-up (2016).|||units on a scale||Standard Deviation|Mean
1320523|NCT02287883|Primary|PROMIS Short Form 8a|Patient Reported Social Functioning, scale 1 (always trouble or limited)-5 (never trouble or limited). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).|1 year|Patients who completed surveys at both baseline (2015) and at one year follow-up (2016).|||units on a scale||Standard Deviation|Mean
1320524|NCT02287779|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626)||Day 1 to Day 14|Pharmacokinetic set. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.||||||
1320525|NCT02287779|Secondary|Maximum Observed Plasma Concentration (Cmax) of Volixibat||Day 1 to Day 14|Pharmacokinetic set consisted of all participants in the safety analysis set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.||||||
1320526|NCT02287779|Secondary|Number of Participants With Stool Hardness Using Bristol Stool Chart|Stool hardness was assessed after each evacuation using the bristol stool chart, a medical aid designed to classify the form of human feces into 7 categories where type 1 is the hardest and type 7 is the softest.|Day -2 to Day 14|Pharmacodynamic set.|||participants|||Number
1320527|NCT02287779|Secondary|Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration|Serum 7- alpha-hydroxy-4-cholesten-3-one (C4) concentrations were reported.|Day -1 to Day 15|Pharmacodynamic set.|||nanogram per milliliter||Standard Deviation|Mean
1320528|NCT02287779|Secondary|Average Total Fecal Bile Acid (FBA) Concentration|Stool samples for the determination of total FBA were collected in 48-hour windows from 48 hours before dosing on Day 1 through Day 14. The average of daily total FBA excretion is calculated before (Day -1 and Day -2) as the first pre dose of IMP and after (Day 1-12) as the first post-dose of IMP. The FBA is calculated as Total FBA (micromoles) = FBA (micromol per liter) * weight (grams) divided by 10^3. Participants with fecal bile acid concentration and their average pre-first dose and average post-first dose were reported.|Day -2 up to Day 14|Pharmacodynamic set consisted of all participant in the safety analysis set for whom the primary pharmacodynamic data were considered sufficient and interpretable.|||nanomoles*gram per liter||Standard Deviation|Mean
1320529|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320530|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320531|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Twelve lead electrocardiogram parameters [(heart rate (HR), PR, RR, QRS and QT intervals and information on T-wave morphology (normal/abnormal) and U-wave morphology (absent/normal or abnormal)] were assessed.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320532|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Vital signs parameter included evaluation of orthostatic blood pressure, respiratory rate and body temperature.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320533|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Urinalysis parameters included evaluation of pH, glucose, protein, nitrites, leukocyte esterase, occult blood, ketones, bilirubin and specific gravity levels.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320534|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Standard chemistry parameters included evaluation of sodium, potassium, glucose, blood urea nitrogen, creatinine, calcium, chloride, thyrotropin, thyroxine, tri-iodothyronine, phosphorus, protein, bicarbonate or carbon dioxide, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, total bilirubin, urate, beta-human chorionic gonadotropin and follicle-stimulating hormone levels. Participant with TEAE related to standard chemistry were reported with hepatic enzyme increase.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set|||participants|||Number
1320535|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Coagulation included international normalized ratio, activated partial thromboplastin time and prothrombin time.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320536|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Thyroid hormone panel parameters included evaluation of thyroid hormones (TSH [thyroid stimulating hormone]; T3 [triiodothyronine] and T4 [thyroxine]).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320537|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Lipid panel parameters included evaluation of total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and low-density lipoprotein (LDL) cholesterol.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320538|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Fat soluble vitamin included vitamin A (serum retinol), vitamin D (serum 25-hydroxycholecalciferol) and vitamin E (serum alfa-tocopherol).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
1320539|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology|TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white blood cell count; total and differential, neutrophils (absolute), eosinophils (absolute), monocytes (absolute), basophils (absolute) and lymphocytes (absolute).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set included all participants for whom a randomization number was assigned and who had taken >= 1 dose of IMP.|||participants|||Number
1320545|NCT02287623|Primary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours after injection||||scores on a scale||Inter-Quartile Range|Median
1320546|NCT02287610|Other Pre-specified|Correlation Between Vectra DA and DAS28 at Each Assessed Time Point|Vectra DA and DAS28 data were collected, however not analyzed or correlated.|Baseline to Last Follow up visit (up to 18.7 weeks)|Analysis and correlations were not completed for this outcome measure.||||||
1320547|NCT02287610|Secondary|Assessment of Unsolicited Serious Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)||||Participants|||Count of Participants
1320548|NCT02287610|Secondary|Assessment of Unsolicited Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)||||Participants|||Count of Participants
1320549|NCT02287610|Secondary|Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)|The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants.|Baseline to Last Follow up visit (up to 18.7 weeks)||||milligrams||Standard Deviation|Mean
1320550|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked “Yes” (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – recent medical history was calculated for participants who had both baseline and follow-up recent medical history data. For this measure, the mean change from baseline is based on 33 participants.|||number of items checked||Standard Deviation|Mean
1320551|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to “Fatigue is no problem” and 10 to “Fatigue is a major problem” over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – fatigue (FAT) was calculated for participants who had both baseline and follow-up FAT data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320552|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)|The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: “3 or more times a week” (3), “1-2 times per week” (2), “1-2 times per month” (1), “Do not exercise regularly” (0), “Cannot exercise due to disability/handicap” (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – exercise (EX) was calculated for participants who had both baseline and follow-up EX data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320553|NCT02287610|Secondary|"Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)"|The Multidimensional Health Assessment Questionnaire (MDHAQ) – how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in “How do you feel” measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire - How do you feel today (compared to 1wk ago) from Baseline to Final Visit was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Error|Mean
1320554|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – morning stiffness, minutes (past week) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 30 participants.|||minutes||Standard Deviation|Mean
1320601|NCT02287376|Secondary|Safety Outcome (6.15 of 7)|• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
1320555|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – review of symptoms (ROS) was calculated for participants who had both baseline and follow-up ROS data. For this measure, the mean change from baseline is based on 33 participants.|||number of symptoms||Standard Deviation|Mean
1320556|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – patient global assessment (PTGL) was calculated for participants who had both baseline and follow-up PTGL data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320557|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)|For the Multidimensional Health Assessment Questionnaire (MDHAQ) – neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as “None” (score of 0), “Mild” (score of 1), “Moderate” (score of 2) or “Severe” (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – neck and back (NB) was calculated for participants who had both baseline and follow-up NB data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320558|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)|For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as “None” (score of 0), “Mild” (score of 1), “Moderate” (score of 2) or “Severe” (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – RADAI patient self-report joint count (PTJT) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320559|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) – pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to “No Pain” and 10 to “Pain as bad as it could be” because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Pain (PN) was calculated for participants who had both baseline and follow-up PN data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320560|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)|The change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as “without any difficulty” (score of 0), “with some difficulty” (score of 1.1), “with much difficulty” (score of 2.2) or “unable to do” (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Psychological status (PS) was calculated for participants who had both baseline and follow-up PS data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320701|NCT02285998|Secondary|Number of Participants With Systemic Reactogenicity|Solicited events of systemic reactogenicity reported during Day 0-7.|Days 0 through 7|Solicited systemic reactogenicity events include subjects who recorded any systemic reaction data.|||participants|||Number
1320561|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)|The change in Multidimensional Health Assessment Questionnaire (MDHAQ) – function (FN) was assessed by asking participants to score the performance of multiple activities as “without any difficulty” (score of 0), “with some difficulty” (score of 1), “with much difficulty” (score of 2) or “unable to do” (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Function (FN) was calculated for participants who had both baseline and follow-up FN data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320562|NCT02287610|Secondary|Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)|"Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up.~RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Routine Assessment of Patient Index Data (RAPID3) was calculated for participants who had both baseline and follow-up data required to calculate RAPID3. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320563|NCT02287610|Secondary|ACR-N From Baseline to Final Visit (Final Follow-up Visit)|ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set–Patient’s global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician’s global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR-N scores and 5 participants have only baseline data. ACR-N calculations were performed on data from 24 participants.|||percent change||Standard Deviation|Mean
1320564|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 70 a patient must demonstrate a >= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR70 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.|||percentage of particpants|||Number
1320565|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 50, a patient must demonstrate a >= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only Baseline data. The percentages were calculated based on 56 participants.|||percentage of participants|||Number
1320566|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 20, a patient must demonstrate a >= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.|||percentage of participants|||Number
1320567|NCT02287610|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)|"European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), >3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 >5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined.~DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity)."|Baseline to Last Follow up visit (up to 18.7 weeks)||||percentage of participants|||Number
1320568|NCT02287610|Secondary|Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)|Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Simple Disease Activity Index (SDAI) was calculated for participants who had both baseline and follow-up data required to calculate SDAI. For this measure, the mean change from baseline is based on 25 participants.|||units on a scale||Standard Deviation|Mean
1320569|NCT02287610|Secondary|Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)|"Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition.~As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Clinical Disease Activity Index (CDAI) was calculated for participants who had both baseline and follow-up data required to calculate CDAI. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
1320570|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.36 * the natural logarithm (ln) of (CRP + 1)] + [0.014 * PGA in mm] + 0.96. A negative change from baseline indicated improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Disease Activity Score in 28 Joints calculated with C-reactive protein (DAS28-CRP) was calculated for participants who had both baseline and follow-up data required to calculate DAS28-CRP. For this measure, the mean change from baseline is based on 25 participants.|||units on a scale||Standard Deviation|Mean
1320571|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * PGA in mm]. A negative change from baseline indicates improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in DAS28-ESR was calculated for participants who had both baseline and follow-up data required to calculate DAS28-ESR. For this measure, the mean change from baseline is based on 15 participants.|||units on a scale||Standard Deviation|Mean
1320585|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
1320572|NCT02287610|Secondary|Change in Physician’s Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|Physician’s Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to “Very Well’ and 10 to “Very Poor”. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician’s Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow-up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Physician’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Physician’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 37 participants.|||units on a scale||Standard Deviation|Mean
1320573|NCT02287610|Secondary|Change in Patient’s Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|Patient’s Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient’s Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Patient’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Patient’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 36 participants.|||units on a scale||Standard Deviation|Mean
1320574|NCT02287610|Secondary|Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. The change in duration of morning stiffness (minutes) was calculated for participants who had both baseline and follow-up morning stiffness data. For duration of morning stiffness, the mean change from baseline is based on 41 participants.|||minutes||Standard Deviation|Mean
1320575|NCT02287610|Primary|Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit|Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to “Not Severe at All” and 100 to “Extremely Severe”. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Mean change in severity of morning stiffness was calculated for participants who had both baseline and follow-up severity of morning stiffness data. For severity of morning stiffness, the mean change from baseline is based on 38 participants.|||units on a scale||Standard Deviation|Mean
1320576|NCT02287415|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.||||ng.h/mL||Standard Deviation|Mean
1320577|NCT02287415|Secondary|Tmax - Time of Occurrence of Cmax||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.||||hours||Full Range|Median
1320578|NCT02287415|Primary|Cmax - Maximum Steady-state Plasma Concentration||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.||||ng/mL||Standard Deviation|Mean
1320579|NCT02287402|Secondary|Body Weight at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||kg||Standard Deviation|Mean
1320580|NCT02287402|Secondary|Body Weight|"Summary statistics were calculated at each assessment time point for the body weight in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||kg||Standard Deviation|Mean
1320581|NCT02287402|Secondary|HbA1c at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||percent||Standard Deviation|Mean
1320582|NCT02287402|Secondary|Hemoglobin A1c (HbA1c)|"Summary statistics were calculated at each assessment time point for the HbA1c in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percent||Standard Deviation|Mean
1320583|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g OGTT at Follow-up|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the Full Analysis Set."|Follow-up at week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||mg/dL||Standard Deviation|Mean
1320584|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the Full Analysis Set."|Week 0, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||mg/dL||Standard Deviation|Mean
1321220|NCT02274870|Secondary|Pain Intensity at Rest|"Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.~Higher values represent a higher pain intensity or worse outcome."|24hrs||||VAS Scale||95% Confidence Interval|Mean
1320586|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
1320587|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to progression to type 2 diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
1320588|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to progression to Type 2 Diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
1320589|NCT02287402|Primary|Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)|"Frequency tabulations of the assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||participants|||Number
1320590|NCT02287402|Primary|Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)|"Frequency tabulations of the assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in the Full Analysis Set."|Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||participants|||Number
1320591|NCT02287376|Secondary|Safety Outcome (7 of 7)|• Physical examination findings including abnormal clinically significant findings|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented is a clinically significant change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Participants|||Count of Participants
1320592|NCT02287376|Secondary|Safety Outcome (6.24 of 7)|• Changes in clinical laboratory results: Urinalysis - Specific Gravity.|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Specific Gravity||Standard Deviation|Mean
1320593|NCT02287376|Secondary|Safety Outcome (6.23 of 7)|• Changes in clinical laboratory results: Urinalysis - pH.|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||pH||Standard Deviation|Mean
1320594|NCT02287376|Secondary|Safety Outcome (6.22 of 7)|• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320595|NCT02287376|Secondary|Safety Outcome (6.21 of 7)|• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320596|NCT02287376|Secondary|Safety Outcome (6.20 of 7)|• Changes in clinical laboratory results: Chemistry - LDH (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1320597|NCT02287376|Secondary|Safety Outcome (6.19 of 7)|• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320598|NCT02287376|Secondary|Safety Outcome (6.18 of 7)|• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
1320599|NCT02287376|Secondary|Safety Outcome (6.17 of 7)|• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320600|NCT02287376|Secondary|Safety Outcome (6.16 of 7)|• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320602|NCT02287376|Secondary|Safety Outcome (6.14 of 7)|• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320603|NCT02287376|Secondary|Safety Outcome (6.13 of 7)|• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1320604|NCT02287376|Secondary|Safety Outcome (6.12 of 7)|• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1320605|NCT02287376|Secondary|Safety Outcome (6.11 of 7)|• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1320606|NCT02287376|Secondary|Safety Outcome (6.10 of 7)|• Changes in clinical laboratory results: Chemistry - Albumin (g/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
1320607|NCT02287376|Secondary|Safety Outcome (6.9 of 7)|• Changes in clinical laboratory results: Hematology - Monocytes (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Monocytes||Standard Deviation|Mean
1320608|NCT02287376|Secondary|Safety Outcome (6.8 of 7)|• Changes in clinical laboratory results: Hematology - Lymphocytes (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Lymphocytes||Standard Deviation|Mean
1320609|NCT02287376|Secondary|Safety Outcome (6.7 of 7)|• Changes in clinical laboratory results: Hematology - Neutrophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Neutrophils||Standard Deviation|Mean
1320610|NCT02287376|Secondary|Safety Outcome (6.6 of 7)|• Changes in clinical laboratory results: Hematology - Eosinophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Eosinophils||Standard Deviation|Mean
1320611|NCT02287376|Secondary|Safety Outcome (6.5 of 7)|• Changes in clinical laboratory results: Hematology - Basophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Basophils||Standard Deviation|Mean
1320612|NCT02287376|Secondary|Safety Outcome (6.4 of 7)|• Changes in clinical laboratory results: Hematology - White Blood Cells (Cells * 10^9/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Cells * 10^9/L||Standard Deviation|Mean
1320613|NCT02287376|Secondary|Safety Outcome (6.3 of 7)|• Changes in clinical laboratory results: Hematology - Platelet Count (Cells * 10^9/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Cells * 10^9/L||Standard Deviation|Mean
1320614|NCT02287376|Secondary|Safety Outcome (6.2 of 7)|• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
1320615|NCT02287376|Secondary|Safety Outcome (6.1 of 7)|• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||L/L||Standard Deviation|Mean
1320616|NCT02287376|Secondary|Safety Outcome (5.5 of 7)|• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mm Hg||Standard Deviation|Mean
1320756|NCT02284555|Secondary|The Number of Subjects With Adverse Events and Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up at 7 and 14 Days Relative to the First Dose.||5 day treatment period and follow-up at 7 and 14 days||||participants|||Number
1320617|NCT02287376|Secondary|Safety Outcome (5.4 of 7)|• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mm Hg||Standard Deviation|Mean
1320618|NCT02287376|Secondary|Safety Outcome (5.3 of 7)|• Changes in vital sign measurements: Respiratory Rate (breaths/min).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||breaths/min||Standard Deviation|Mean
1320619|NCT02287376|Secondary|Safety Outcome (5.2 of 7)|• Changes in vital sign measurements: Heart Rate (beats/min).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||beats/min||Standard Deviation|Mean
1320620|NCT02287376|Secondary|Safety Outcome (5.1 of 7)|• Changes in vital sign measurements: Temperature (degrees C).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||degrees C||Standard Deviation|Mean
1320621|NCT02287376|Secondary|Safety Outcome (4 of 7)|• Deaths|3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320622|NCT02287376|Secondary|Safety Outcome (3 of 7)|• Withdrawals due to AEs|3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320623|NCT02287376|Secondary|Safety Outcome (2 of 7)|• Serious adverse events (SAEs)|3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320624|NCT02287376|Secondary|Safety Outcome (1 of 7)|• Treatment emergent AEs (TEAEs)|3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320625|NCT02287376|Primary|Pharmacokinetics Outcome (6 of 6)|• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min*ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min*ng/mL||Standard Deviation|Mean
1320626|NCT02287376|Primary|Pharmacokinetics Outcome (5 of 6)|• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min*ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min*ng/mL||Standard Deviation|Mean
1320627|NCT02287376|Primary|Pharmacokinetics Outcome (4 of 6)|• t1/2: terminal elimination half-life (min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min||Standard Deviation|Mean
1320628|NCT02287376|Primary|Pharmacokinetics Outcome (3 of 6)|• λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||1/min||Standard Deviation|Mean
1320629|NCT02287376|Primary|Pharmacokinetics Outcome (2 of 6)|• tmax: time to maximum concentration (min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min||Standard Deviation|Mean
1320630|NCT02287376|Primary|Pharmacokinetics Outcome (1 of 6)|• Cmax: maximum concentration (ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||ng/mL||Standard Deviation|Mean
1320631|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).|• Physical examination findings including abnormal clinically significant findings|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented is any new or worsened clinically significant abnormal change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Participants|||Count of Participants
1320632|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).|• Changes in clinical laboratory results: Urinalysis - Specific Gravity.|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Specific Gravity||Standard Deviation|Mean
1320702|NCT02285998|Secondary|Measure of Post-vaccination HAI GMTs|GMT titers for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.|||titer||95% Confidence Interval|Geometric Mean
1320633|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).|• Changes in clinical laboratory results: Urinalysis - pH.|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||pH||Standard Deviation|Mean
1320634|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).|• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320635|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).|• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320636|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).|• Changes in clinical laboratory results: Chemistry - LDH (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1320637|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).|• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320638|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).|• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
1320639|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).|• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320640|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).|• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320641|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).|• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
1320642|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).|• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
1320643|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).|• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1320644|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).|• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1330831|NCT02091752|Secondary|Change From Baseline in MPN-SAF TSS Score||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1320645|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).|• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
1320646|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).|• Changes in clinical laboratory results: Chemistry - Albumin (g/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
1320647|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).|• Changes in clinical laboratory results: Hematology - Monocytes (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Monocytes||Standard Deviation|Mean
1320648|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).|• Changes in clinical laboratory results: Hematology - Lymphocytes (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Lymphocytes||Standard Deviation|Mean
1320649|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).|• Changes in clinical laboratory results: Hematology - Neutrophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Neutrophils||Standard Deviation|Mean
1320650|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).|• Changes in clinical laboratory results: Hematology - Eosinophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Eosinophils||Standard Deviation|Mean
1320651|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).|• Changes in clinical laboratory results: Hematology - Basophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Basophils||Standard Deviation|Mean
1320652|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).|• Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||10^9/L||Standard Deviation|Mean
1320653|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).|• Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||10^9/L||Standard Deviation|Mean
1320654|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).|• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
1320655|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).|• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||L/L||Standard Deviation|Mean
1320656|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).|• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||mmHg||Standard Deviation|Mean
1320657|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).|• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||mmHg||Standard Deviation|Mean
1320658|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).|• Changes in vital sign measurements: Respiratory Rate (breaths/min).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||breaths/min||Standard Deviation|Mean
1320659|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).|• Changes in vital sign measurements: Pulse Rate (beats/min).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||beats/min||Standard Deviation|Mean
1320660|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).|• Changes in vital sign measurements: Temperature (degrees C).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||degrees C||Standard Deviation|Mean
1320661|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).|• Deaths|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320662|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).|• Withdrawals due to AEs|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320663|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).|• Serious adverse events (SAEs)|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320664|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).|• Treatment emergent AEs (TEAEs)|4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
1320665|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).|• Vz/F: apparent volume of distribution (mL).|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||mL||Standard Deviation|Mean
1320666|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).|• CL/F: apparent clearance (mL/hr).|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||mL/hr||Standard Deviation|Mean
1320667|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).|• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr*ng/mL||Standard Deviation|Mean
1320668|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).|• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr*ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr*ng/mL||Standard Deviation|Mean
1320669|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).|• t1/2: terminal elimination half-life (hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr||Standard Deviation|Mean
1320749|NCT02284854|Primary|Cmax (BIA 2-093) - the Maximum Plasma Concentration|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35||||ng/mL||Standard Deviation|Mean
1320670|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).|• λz: elimination rate constant (1/hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||1/hr||Standard Deviation|Mean
1320671|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).|• Tmax: time to maximum concentration (hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr||Full Range|Median
1320672|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).|• Cmax: maximum concentration (ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||ng/mL||Standard Deviation|Mean
1320673|NCT02287025|Secondary|Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire|Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
1320674|NCT02287025|Secondary|Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire|Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
1320675|NCT02287025|Secondary|Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension|Documented during visits as part of the interval history. All AEs will be reported in the CRF with a diagnosis, start/stop dates, action taken.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
1320676|NCT02287025|Secondary|Dose Intensity as Percentage of Planned Dose|Dose level 0 (standard starting dose) @ 160mg po qd. Dose level - 1 @ 120 mg po qd. Dose level - 2 @ 80 mg po qd. This schedule reflects the FDA-approved dosing specified in the prescribing information.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
1320677|NCT02287025|Secondary|Duration of Treatment||Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
1320678|NCT02287025|Primary|Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death||Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
1320679|NCT02286518|Secondary|Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1|Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected.|Day 1: 0 to 48 hours postdose|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||percentage of dose||Standard Deviation|Mean
1320680|NCT02286518|Secondary|Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3|Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||ratio||Standard Deviation|Mean
1320681|NCT02286518|Secondary|Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3|Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||ratio||Standard Deviation|Mean
1320682|NCT02286518|Secondary|Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114||Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||hour||Standard Deviation|Mean
1320683|NCT02286518|Secondary|AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3||Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||pg*hr/mL||Standard Deviation|Mean
1320684|NCT02286518|Secondary|AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2||Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||picogram*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
1320685|NCT02286518|Secondary|Cmax - Maximum Observed Plasma Concentration for TAK-114||Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
1320686|NCT02286518|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
1320687|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1|The safety analysis set includes all participants who received the study drug.|||participants|||Number
1320688|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)|Number of participants who had ECG shifts from “within normal limit” at baseline to “abnormal, clinically significant” after study drug administration were reported.|Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
1320689|NCT02286518|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
1320690|NCT02286518|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
1320691|NCT02286518|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)|The safety analysis set includes all participants who received the study drug.|||participants|||Number
1320692|NCT02286466|Secondary|Change in Depression Symptoms From Baseline to Post-assessment|Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a brief, validated measure of major depression per the criteria of the Diagnostic and Statistical Manual of Mental Disorders. Patients respond to 9 questions on a scale of 0 (not at all) to 3 (nearly every day). The total scale score ranges from 0 to 27, with higher scores indicating worse depression symptoms.|1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Patient Health Questionnaire-9 (PHQ-9).|||Units on a scale||Standard Error|Mean
1320693|NCT02286466|Secondary|Change in Mood Symptoms From Baseline to Post-assessment|Hospital Anxiety & Depression Scale (HADS): The HADS is a self-report instrument that was designed for medical patients and demonstrates adequate psychometric properties for use among individuals with cancer. Comprised of 14-items that are scored on a 4-point Likert scale, the instrument contains two subscales that measure anxiety and depression symptoms in the past week. Total scores for each subscale range from 0 (no distress) to 21 (maximum distress).|1) Baseline (within 2 weeks after enrollment), 2) and Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hospital Anxiety & Depression Scale (HADS).|||Units on a scale||Standard Error|Mean
1320694|NCT02286466|Secondary|Change in Quality of Life From Baseline to Post-assessment|Functional Assessment of Cancer Therapy-General: The FACT-G is a valid and reliable self-report, 27-item instrument, consisting of 4 subscales that evaluate physical, functional, emotional and social wellbeing during the past 7 days. Items are scored using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate better quality of life, while lower scores indicate worse quality of life.|1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Functional Assessment of Cancer Therapy-General (FACT-G).|||Units on a scale||Standard Error|Mean
1320695|NCT02286466|Primary|Change in Anxiety Symptoms From Baseline to Post-assessment|Hamilton Anxiety Rating Scale (HAM-A): The HAM-A is a clinician-administered interview used widely in psychiatry research to evaluate anxiety symptoms. Consisting of 14 items that are scored on a scale from 0 (not present) to 4 (very severe), the HAM-A total score ranges from 0 to 56, with higher scores indicating worse anxiety symptoms.|1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hamilton Anxiety Rating Scale (HAM-A).|||Units on a scale||Standard Error|Mean
1320696|NCT02286193|Secondary|Number of Participants Setting a Goal With Their CRS|Number of patients who completed at least one visit with the CRS and set a specific action-based goal with their CRS. Patients could meet with the CRS and receive referrals to resources without setting specific action-based goals. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months||||participants|||Number
1320697|NCT02286193|Primary|Number of Participants Receiving a Resource for Community Services|Number of patients who completed at least one visit with the CRS and were given a referral for at least one resource, service, or organization. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months||||participants|||Number
1320698|NCT02286102|Secondary|Hemoglobin Levels, Post-Op Day 2|Hemoglobin levels will be measured post-operatively day 2|2 days postop||||g/Dl (grams/deciliter)||Standard Deviation|Mean
1320699|NCT02286102|Secondary|Hemoglobin Levels, Post-Op Day 3|Hemoglobin levels will be measured post-operatively day 3|3 days postop||||g/Dl (grams/deciliter)||Standard Deviation|Mean
1320700|NCT02286102|Primary|Volume of Allogenic Blood Transfused Postoperatively|The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.|48 hours postoperative||||mL||Standard Deviation|Mean
1331697|NCT02074059|Secondary|PCO2|Arterial carbon dioxide|Within 3 Hours of Randomization|Safety Population|||percentage of arterial carbon dioxide||Standard Deviation|Mean
1320703|NCT02285998|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)|"Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination).~A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment."|Day 0 through and up to 32 weeks post vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.|||participants|||Number
1320704|NCT02285998|Secondary|Number of Participants With Unsolicited Adverse Events|Unsolicited adverse events reported in the 28 days following vaccine administration.|Days 0 through 28|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.|||participants|||Number
1320705|NCT02285998|Secondary|Number of Participants With Local Injection Site Reactogenicity|Solicited events of injection site reactogenicity reported during Day 0-7.|Days 0 through 7|Solicited local reactogenicity events include subjects who recorded any injection site reaction data.|||participants|||Number
1320706|NCT02285998|Secondary|Percentage of Participants With Seroconversion|Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.|||percentage of participants||95% Confidence Interval|Number
1320707|NCT02285998|Secondary|Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness|rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
1320708|NCT02285998|Secondary|Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness|"Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines.~CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat."|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
1320709|NCT02285998|Secondary|Number of Participants With Culture-confirmed Influenza-Like Illness|"Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines.~Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms:~Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)"|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
1320710|NCT02285998|Primary|Number of Participants With rtPCR-confirmed Influenza-Like Illness|rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
1320711|NCT02285907|Secondary|Plasma Amino Acids|Plasma amino acid concentrations were measured from the pre and hourly postprandial time points until dinner request following the Macronutrient and Fiber Matched BEEF meal and the Serving Size Matched Beef Meal. An average amino acid concentration was then determined from the change from baseline concentration for all available time points. Plasma amino acid analyses were performed through the University of Missouri-Columbia Agricultural Experiment Station Chemical Laboratories using cation-exchange chromatography (cIEC-HPLC) coupled with post-column ninhydrin derivatization and quantitation.|1 day|Four participants were excluded because of insufficient time points.|||pg/ml||Standard Error|Mean
1320712|NCT02285907|Primary|Food Cue-stimulate fMRI Brain Scans|Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category were presented in blocks of images. Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing). To determine the effects of protein type on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus [food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing] and protein source (BEEF vs. SOY) comparisons within the macronutrient and fiber–matched condition and the serving size–matched conditions, separately. The mean percent signal change in the maximum voxel within each region that displayed significant activation after the BEEF and SOY meals was then determined. Talairach coordinates for each region are presented for each row as (x;y;z).|3 hours||||percent signal change||Standard Error|Mean
1320713|NCT02285907|Primary|Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY)|The samples were collected in test tubes containing ethylenediaminetetraacetic acid. Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation. The plasma was separated and stored in microcentrifuge tubes at -80°C for future analysis. Plasma total glucagon-like peptide (GLP-1) and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay (Millipore, St. Charles, MO) and Magpix Luminex technologies (Luminex Corporation, Austin, TX). niAUC was calculated for perceived circulating GLP-1 and PYY throughout the testing period by computing the summation of the average change from baseline score (units of pg/ml) for each time point and the subsequent time point, multiplied by the difference in time (units of min) between the two time instances (also referred to as the trapezoidal rule).|1 Day||||pg/ml*min||Standard Error|Mean
1331698|NCT02074059|Primary|Serum Electrolytes||24 Hours Post Randomization|All randomized subjects|||mEq/L||Standard Deviation|Mean
1320714|NCT02285907|Primary|Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness|"Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days. The questionnaires contained a visual analog scale incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as “how strong is your feeling of” with anchors of “not at all” to “extremely.” Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated for perceived hunger and fullness by computing the summation of the average change from baseline score (units of mm) for each time point and the subsequent time point, multiplied by the difference in time (units of min) between the two measures (also referred to as the trapezoidal rule). For reported feelings of hunger, a higher score can be interpreted as feeling more hungry throughout the day. For reported feelings of fullness, a higher can be interpreted as feeling more full throughout the day."|1 Day||||mm*min||Standard Error|Mean
1320715|NCT02285907|Primary|Subsequent Food Intake|Ad libitum dinner and snacks were provided. Energy content and macronutrient content of these eating occasions were assessed.|1 Day||||kilocalories||Standard Error|Mean
1320716|NCT02285907|Primary|Eating Initiation|Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.|1 Day||||minutes||Standard Error|Mean
1320717|NCT02285777|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.|The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.|During the entire study period (from Day 0 up to Month 10)|Analysis was performed on Safety Set (overall)- included all screened subjects who provide informed consent and demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and have either post-vaccination reactogenicity data or post-vaccination unsolicited adverse event records.|||Participants|||Count of Participants
1320718|NCT02285777|Secondary|Number of Subjects Reporting Any Unsolicited AEs|The number of subjects reporting unsolicited AEs after any vaccination is reported. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Day 1 to Day 30 after any vaccination|Analysis was performed on Safety set (unsolicited AEs)- included all screened subjects who provided informed consent & demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and had post-vaccination unsolicited adverse event records.|||Participants|||Count of Participants
1320719|NCT02285777|Secondary|Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)|Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.|Day 1 (6 hours) to Day 7 after vaccination|Analysis was performed on Safety Set (solicited AEs & other solicited reactions)-included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & a study vaccination, & provided post-vaccination reactogenicity data.|||Participants|||Count of Participants
1320720|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ (≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128) against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.|||Percentages of subjects||95% Confidence Interval|Number
1320721|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ (≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128) against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.|||Percentages of subjects||95% Confidence Interval|Number
1320722|NCT02285777|Secondary|HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.|The immunogenicity of three doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at 1 and 4 months after the 3-dose vaccination series.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Titers||95% Confidence Interval|Geometric Mean
1320750|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
1320751|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
1320723|NCT02285777|Secondary|Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)||2018-06-30|06/2018||||
1320724|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ (≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128) against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
1320725|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ (≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128) against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
1320726|NCT02285777|Secondary|HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Titers||95% Confidence Interval|Geometric Mean
1320727|NCT02285777|Secondary|Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
1320728|NCT02285777|Secondary|Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series|The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).|At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Months 6, 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, got subject ID & vaccination, & provided serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain before Month 6 & at Months 7 & 10|||Percentage||Standard Deviation|Mean
1320729|NCT02285777|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.|The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Months 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Months 7 & 10.|||Percentages of subjects|||Number
1320752|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
1320753|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
1320754|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
1320755|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
1320730|NCT02285777|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.|The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 10|||Percentages of subjects|||Number
1320731|NCT02285777|Primary|Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.|The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Month 7)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination,& who provided evaluable serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 7.|||Percentages of subjects|||Number
1320732|NCT02285270|Secondary|Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.||||||
1320733|NCT02285270|Secondary|Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.||||||
1320734|NCT02285270|Primary|Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.||||||
1320735|NCT02284893|Secondary|Mean Change in Fasting Plasma Glucose (FPG)||Baseline (randomization) to Week 26|randomized subjects|||mg/dl||Standard Error|Mean
1320736|NCT02284893|Secondary|Mean Change in Total Body Weight||Baseline (randomization) to Week 26|randomized subjects|||kg||Standard Error|Mean
1320737|NCT02284893|Secondary|Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%||week 26|randomized subjects|||Percentage of subjects|||Number
1320738|NCT02284893|Primary|Mean Change in HbA1c||Baseline (randomization) to Week 26|"The Randomized Subjects data set consists of all randomized subjects who received at least~1 dose of double-blind study drug during the double-blind treatment period. Data in this data set were analyzed based on randomized treatment group, even if the treatment they received was different"|||percentage (%)||Standard Error|Least Squares Mean
1320739|NCT02284880|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|"Reference - MF - marketed formulation Test - TBM - to-be-marketed~BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period||||ng.hr/ml||Standard Deviation|Mean
1320740|NCT02284880|Primary|Tmax - Time of Occurrence of Cmax|"Reference - MF - marketed formulation Test - TBM - to-be-marketed~BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period||||hours||Full Range|Median
1320741|NCT02284880|Primary|Cmax - Maximum Plasma Concentration|Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period||||ng/ml||Standard Deviation|Mean
1320742|NCT02284867|Secondary|Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups|CD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.|2 years||||participants|||Number
1320743|NCT02284867|Primary|Uterine Natural Killer Cells In Preterm Labor|Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample|2 years||||participants|||Number
1320744|NCT02284854|Primary|AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg~CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35||||ng*h/mL||Standard Deviation|Mean
1320745|NCT02284854|Primary|AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35||||ng*h/mL||Standard Deviation|Mean
1320746|NCT02284854|Primary|AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35||||ng*h/mL||Standard Deviation|Mean
1320747|NCT02284854|Primary|Cmax (CBZE) - the Maximum Plasma Concentration|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily~CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35||||ng/mL||Standard Deviation|Mean
1320748|NCT02284854|Primary|Cmax (CBZ) - the Maximum Plasma Concentration|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35||||ng/mL||Standard Deviation|Mean
1320757|NCT02284555|Primary|Apparent Eradication of Nasal Carriage of SA|Apparent eradication demonstrated by a semi-quantitative score of negative or zero using a broth enriched culture microbial assay.|48 hours after the last dose of mupirocin 2%||||participants|||Number
1320758|NCT02284516|Secondary|Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42|Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).|Baseline to Day 14 and Day 42|ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively.|||units on a scale||Standard Deviation|Mean
1320759|NCT02284516|Primary|Change From Baseline in Patient-Reported Eye Dryness Score to Day 84|Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).|Baseline to Day 84|Intent to treat (ITT) population included all randomized participants who took at least 1 dose of investigational product with last observation carried forward (LOCF). Here, n = number of participants analyzed for the specific categories of each arm, respectively.|||units on a scale||Standard Deviation|Mean
1320760|NCT02284386|Primary|The Apparent Terminal Elimination Half-life (t1/2el)||Baseline through Day 14||||hours||Standard Deviation|Mean
1320761|NCT02284386|Primary|The Apparent Terminal Elimination Rate Constant (λz)||Baseline through Day 14||||1/hours||Standard Deviation|Mean
1320762|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)||Baseline through Day 14||||hours x ng/mL||Standard Deviation|Mean
1320763|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)||Baseline through Day 14||||hours x ng/mL||Standard Deviation|Mean
1320764|NCT02284386|Primary|Time to Peak Plasma Concentration (Tmax)||Baseline through Day 14||||hours||Full Range|Median
1320765|NCT02284386|Primary|Maximum Plasma Concentration (Cmax)||Baseline through Day 14|Of 15 subjects, one subject was removed as an outlier|||ng/mL||Standard Deviation|Mean
1320766|NCT02284347|Secondary|Device Safety Profile as Measured by the Overall Adverse Event Rate|Overall adverse event rate|2 weeks||||Percentage of participants with an AE|||Number
1320767|NCT02284347|Primary|Device-related Adverse Event Point Estimate|The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.|2 weeks|Participants|||Adverse Events||95% Confidence Interval|Number
1320768|NCT02284347|Primary|Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium|Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium|At time of surgery|All patients that completed the study|||Number of sinuses|||Number
1320769|NCT02284243|Secondary|Number of Subjects With Complete Protection From PONV||24 hours|mITT population, including all randomized subjects who received at least one study dose|||participants|||Number
1320770|NCT02284243|Secondary|Time to First Rescue Medication Use|Kaplan Meier analysis of time to first use of rescue analgesia 50th percentile of subjects. Rescue analgesia (oral oxycodone) was available to subjects with inadequately controlled pain. All doses of rescue analgesia administered were recorded and the time from the first study dose to first rescue analgesia in each subject was evaluated. A longer time to first rescue is better.|48 hours|mITT population, including all randomized subjects who received at least one study dose|||hours||95% Confidence Interval|Median
1320771|NCT02284243|Secondary|Use of Rescue Medication (Oral Opioids)|Number of subjects requiring rescue medication (Oral opioids) within 48 hours after first study dose|48 hours|mITT population, including all randomized subjects who received at least one study dose|||participants|||Number
1320772|NCT02284243|Secondary|Number of Subjects With Significant Pain Improvement Following the First Study Dose.||6 hours|mITT population, including all randomized subjects who received at least one study dose|||participants|||Number
1320773|NCT02284243|Secondary|Time to Perceptible and Meaningful Pain Relief|Kaplan-Meier analysis of time to perceptible and meaningful pain relief for 50th percentile of subjects. Time to perceptible pain relief and time to meaningful pain relief were measured using the double-stopwatch method. The first stopwatch was given to each subject with the instructions to stop the watch when they first perceive pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they are first experiencing meaningful pain relief (time to meaningful relief). A shorter time to pain relief is better.|6 hours|mITT population, including all randomized subjects who received at least one study dose|||minutes||95% Confidence Interval|Median
1320774|NCT02284243|Secondary|SPID at Various Other Time Points|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|Up to 48 Hours|mITT population, including all randomized subjects who received at least one study dose|||units on a scale||Standard Deviation|Mean
1320775|NCT02284243|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48).|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|48 hours|mITT population, including all randomized subjects who received at least one study dose|||units on a scale||Standard Deviation|Mean
1320776|NCT02284165|Secondary|Number of Participants Who Died Within 12 Months of Stroke Hospitalization|Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.|||participants|||Number
1320777|NCT02284165|Secondary|Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.|All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.|||participants|||Number
1320778|NCT02284165|Secondary|Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.|Institutionalization (primary living location in a nursing home for long-term care and not for rehabilitation or short-term skilled stay) as measured by patient or proxy family member report on 12-month follow-up phone call.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 patients met these criteria.|||participants|||Number
1320779|NCT02284165|Secondary|Quality of Life (QOL)|EuroQOL-5 Dimensions (EQ-5D) to assess health-related quality of life by asking and scoring the level of severity (1 = no problems, 2 = some problems, 3 = extreme problems) in 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score for each question is added together to provide total score, which is converted to provide a range from 1 (maximum and highest health state for quality of life) down to 0 (lowest health state and quality of life).|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 323 patients met these criteria.|||units on a scale||Inter-Quartile Range|Median
1320780|NCT02284165|Secondary|Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge|12-month functional status as measured by modified Rankin scale scores ranging between 0 (no symptoms) and 6 (death), among patients discharged to inpatient rehabilitation or skilled nursing facility. Outcome measure reports number of participants with Rankin score of 3-6. The outcome was not assessed among patients discharged home.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 participants met these criteria.|||participants|||Number
1320781|NCT02284165|Primary|Home-time|Number of days alive and living outside of inpatient care|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehab or skilled nursing care and without survival limitations identified in-hospital. 69,212 patients met these criteria.|||days||Standard Deviation|Mean
1320782|NCT02284165|Primary|Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services|Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.|discharge through 90 days|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, analyzed as one cohort rather than by arm to differentiate the different types of rehabilitation services within the full patient population.|||participants|||Number
1320783|NCT02283840|Primary|Tmax BIA 2-005 - Time of Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration||||hours||Standard Deviation|Median
1320784|NCT02283840|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration||||ng.h/mL||Standard Deviation|Mean
1320785|NCT02283840|Primary|Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration||||ng/mL||Standard Deviation|Mean
1320786|NCT02283827|Secondary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration||||hours||Standard Deviation|Median
1320787|NCT02283827|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|"AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time~BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate"|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration||||ng*h/mL||Standard Deviation|Mean
1320788|NCT02283827|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration||||ng/mL||Standard Deviation|Mean
1320789|NCT02283814|Secondary|AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.||Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h||||ng.h/mL||Standard Deviation|Mean
1320790|NCT02283814|Primary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h||||hours||Standard Deviation|Mean
1320791|NCT02283814|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h||||ng/mL||Standard Deviation|Mean
1320792|NCT02283788|Secondary|QTcF - QT Interval Corrected Using Fridericia’s Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose|||||||
1320793|NCT02283788|Secondary|QTcB - QT Interval Corrected for Heart Rate Using Bazett’s Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose|||||||
1320794|NCT02283788|Primary|QTcI - QT Interval Individually Corrected for Heart Rate - Day 5||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose||||msec||Standard Deviation|Mean
1320795|NCT02283749|Secondary|Overall Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo|To measure overall survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo|During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment||||Participants|||Count of Participants
1320796|NCT02283749|Secondary|Progression-free Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo|To measure progression-free survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo. Post 1 year of follow up the number of patients that remain stable or responding|During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment|Post 1 year of follow up the number of patients that remain stable or responding|||Participants|||Count of Participants
1320797|NCT02283749|Primary|Number of Symptomatic Skeletal Events (SSE) in Patients Receiving Xofigo With NSCLC and Bone Metastases|Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases|Approximately every 2 months for up to a year||||Number of participants experiencing SSE|||Number
1320798|NCT02283411|Secondary|The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG).|Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the capillary blood glucose (BG) value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for capillary blood glucose (BG) levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had approximately112 capillary blood glucose (BG) samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the BG value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG levels <80 mg/dL.|14 days|A total number of 11444 paired points between sensor glucose readings and BG glucose are used as the denominator to calculate the percentage of sensor glucose readings that are within ±20% of the BG reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG glucose levels <80 mg/dL.|||Percentage of paired points|Pairs||Number
1320799|NCT02283411|Secondary|The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated.|The Continuous Glucose Error Grid Analysis (CG-EGA) in the Hypoglycemic range (YSI ≤ 70 mg/dL), in the Euglycemic range (70 < YSI ≤ 180 mg/dL) and in the Hyperglycemic range (YSI > 180 mg/dL) were evaluated.|14 days|A total of 13566 paired points between sensor glucose readings and YSI glucose were used to calculate and evaluate the percentage of sensor glucose readings at different glucose rates of change and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges) in System P only.|||% of paired points|Pairs||Number
1320800|NCT02283411|Secondary|The Trend Accuracy of the System P Device Performance Was Evaluated.|Trend accuracy of the device performance was assessed by comparing of the glucose rate of change results between the sensor glucose readings and YSI reference results for System P only.|14 days|A total number of 13566 paired points between sensor glucose readings and YSI glucose are used as the denominator to calculate the absolute difference between the rates of change corresponding to Sensor Reading (GM) and YSI results.|||Percentage of paired points|Pairs||Number
1320801|NCT02283411|Primary|Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants.|Safety of the Abbott Sensor Based Glucose Monitoring Systems, including adverse device effects and serious adverse device effects were assessed for all participants enrolled in the study.|Safety was evaluated throughout the subject’s study participation.|All 125 subjects who participated in the study are included in this outcome measure.|||Participants|||Count of Participants
1320802|NCT02283411|Primary|The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI).|Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL.|14 days|A total number of 14284 paired points between sensor glucose readings and YSI glucose are used as the denominator to calculate the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL.|||percentage of paired points|Pairs||Number
1320835|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Per protocol|||participants|||Number
1320803|NCT02283268|Secondary|Pharmacokinetics: Volume of Distribution at Steady State (Vss)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Vss will be calculated as the clearance multiplied with the mean residence time.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||dL/kg||Geometric Coefficient of Variation|Geometric Mean
1320804|NCT02283268|Secondary|Pharmacokinetics: Elimination Phase Half-life (T1/2)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Terminal or disposition half-life (T1/2) will be calculated as ln2/λz where λz is the terminal elimination rate constant as calculated in WinNonlin NCA using at least three quantifiable concentrations.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours||Geometric Coefficient of Variation|Geometric Mean
1320805|NCT02283268|Secondary|Pharmacokinetics: Incremental Recovery (IR)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Incremental recovery will be calculated as (Cmax minus Cpreinfusion) divided by the dose (IU/kg) where kg refers to the body weight at the time of dosing and Cmax is the observed maximum concentration before correction for pre-infusion values.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||IU/dL||Standard Deviation|Mean
1320806|NCT02283268|Secondary|Pharmacokinetics: Clearance (CL)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Clearance will be calculated as dose (IU/kg) divided by the area under the curve time 0 to infinity.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||dL/hour/kg||Geometric Coefficient of Variation|Geometric Mean
1320807|NCT02283268|Secondary|Pharmacokinetics: Mean Residence Time (MRT)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Mean residence time will be calculated as area under the first moment curve from time 0 to infinity divided by the area under the curve time 0 to infinity minus T/2 where T is the duration of the infusion.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours||Geometric Coefficient of Variation|Geometric Mean
1320808|NCT02283268|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC 0-∞ /Dose)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. The area under the plasma concentration/time curve from time 0 to infinity and the area under the first moment curve from time 0 to infinity will be calculated as the sum of AUC or AUMC from time 0 to the time of last quantifiable concentration plus a tail area correction calculated as Ct/λz and Ct/λz(t+1/λz), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and λz is the terminal or disposition rate constant.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours*IU/dL||Geometric Coefficient of Variation|Geometric Mean
1320818|NCT02283268|Secondary|Intraoperative Actual Blood Loss Relative to Predicted Blood Loss|Actual blood loss relative to predicted blood loss will be calculated as [Actual Blood loss (mL)] divided by [Predicted Blood Loss (mL) multiplied by 100.|Day 0 (at completion of surgery)|Number of participants analyzed is 11, as for 3 participants the actual and the predicted blood loss was zero and for 1 participant the predicted blood loss was not collected. Therefore 'actual blood loss relative to predicted blood loss' could not be calculated. The full analysis data set was used for the analysis of this outcome measure.|||Percent||Standard Deviation|Mean
1321221|NCT02274870|Primary|Pain Intensity at Movement|"Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.~Higher values represent a higher pain intensity or worse outcome."|24hrs||||VAS Scale||95% Confidence Interval|Mean
1320809|NCT02283268|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion (AUC 0-72 h/Dose)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. The area under the plasma concentration/time curve from 0 to 72 hours post-infusion will be computed using the linear trapezoidal rule. For the calculation of AUC(0-72h) the levels at 72 hours will be linearly interpolated/extrapolated from the 2 nearest sampling time points.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours*IU/dL||Geometric Coefficient of Variation|Geometric Mean
1320810|NCT02283268|Secondary|Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins, Mouse Immunoglobulin G (IgG) or Recombinant Furin (rFurin)|Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.|Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Participants|||Count of Participants
1320811|NCT02283268|Secondary|Number of Participants Who Developed Inhibitory and Total Binding Antibodies to Von Willebrand Factor (VWF) and Inhibitory Antibodies to Factor VIII (FVIII)|Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.|Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Participants|||Count of Participants
1320812|NCT02283268|Secondary|Occurrence of Severe Allergic Reactions (eg, Anaphylaxis)|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for severe allergic reactions.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Adverse Events|||Number
1320813|NCT02283268|Secondary|Occurrence of Thrombotic Events|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for thrombotic events.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Adverse Events|||Number
1320814|NCT02283268|Secondary|Occurrence of Adverse Events|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Adverse Events|||Number
1320815|NCT02283268|Secondary|Daily Intra- and Postoperative Weight-adjusted Dose of rVWF With or Without ADVATE||Daily, from day of surgery through postoperative Day 14 (± 2 days)|Number of participants analyzed is different for the time points according to individual treatment. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||IU/kg||Inter-Quartile Range|Median
1320816|NCT02283268|Secondary|Intraoperative Hemostatic Efficacy Score as Assessed by the Operating Surgeon|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.~Excellent: Intraoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject.~Good: Intraoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject.~Moderate: Intraoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate.~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate."|Day 0 (at completion of surgery)|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||Participants|||Count of Participants
1320817|NCT02283268|Secondary|Intraoperative Actual Versus Predicted Blood Loss Score as Assessed by the Operating Surgeon|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.~Excellent: Intraoperative blood loss was less than or equal to the maximum blood loss expected for the type of procedure performed in a hemostatically normal subject (≤ 100%).~Good: Intraoperative blood loss was up to 50% more than the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (101-150%) Moderate: Intraoperative blood loss was more than 50% of the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (>150%).~None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of clotting factor replacement regimen."|Day 0 (at completion of surgery)|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||Participants|||Count of Participants
1320834|NCT02282813|Secondary|Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Intent to treat|||participants|||Number
1320819|NCT02283268|Secondary|Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon|"The predicted blood loss will be estimated preoperatively by the operating surgeon based on a hemostatically normal individual of the same sex, age, stature and co-morbidities as the participant.~The actual blood loss will be assessed consisting of the estimated blood loss, including into swabs, towels and suction during the procedure, per the anesthesiologist's record."|Day 0 (at completion of surgery)|For predicted blood loss the number of participants analyzed is 14 as for one participant (included in the major surgery reporting group) the predicted blood loss was not collected. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||mL||Standard Deviation|Mean
1320820|NCT02283268|Primary|Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician)|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.~Excellent: Intra-, and postoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject.~Good: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject.~Moderate: Intra-, and postoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate.~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate."|24 hours after last peri-operative infusion or at completion of Day 14 (± 2 days) visit, whichever occurs earlier|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||Participants|||Count of Participants
1320821|NCT02282982|Secondary|Proportion of Participants With a Particular Co-morbidity|The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
1320822|NCT02282982|Secondary|Median Duration of Oxygen Administration During Hospitalizations|The median duration of mechanical oxygen administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
1320823|NCT02282982|Secondary|Median Duration of Mechanical Ventilation Administration During Hospitalizations|The median duration of mechanical ventilation administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
1320824|NCT02282982|Secondary|Proportion of Participants With Co-morbidities During Hospitalizations|The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
1320825|NCT02282982|Secondary|Proportion of Participants With Missed Doses of Palivizumab|The proportion of participants with missed or delayed doses of palivizumab was documented.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
1320826|NCT02282982|Secondary|Proportion of Participants Who Received Mechanical Ventilation While Hospitalized|The proportion of participants who received mechanical ventilation while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
1320827|NCT02282982|Secondary|Proportion of Participants Who Received Supplemental Oxygen While Hospitalized|The proportion of participants who received supplemental oxygen while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
1320828|NCT02282982|Secondary|Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)|The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
1320829|NCT02282982|Secondary|Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants|The number of hospitalized participants admitted to the Intensive Care Unit was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
1320830|NCT02282982|Secondary|Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test|The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
1320831|NCT02282982|Primary|Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection|Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
1320832|NCT02282982|Primary|Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test|Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
1320833|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Per protocol|||participants|||Number
1320836|NCT02282813|Primary|Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Intent to treat|||participants|||Number
1320837|NCT02282722|Secondary|Patient-Reported Prognostic Understanding in Median Years|Prognostic understanding was assessed by asking patients about their understanding of the prognosis of the typical patient with their condition (<1 year, 1-2 years, 2- 3 years, 3-5 years, 5-10 years, >10 years). This measure was adapted from the CANCORS trial.|3 months||||years||Inter-Quartile Range|Median
1320838|NCT02282722|Secondary|Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment|Emotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable.|3 months||||units on a scale||Standard Deviation|Mean
1320839|NCT02282722|Secondary|Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale|Decisional Regret was assessed at the 3-month survey using Brehaut’s 5-item decisional regret scale, with scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret.|3 months||||units on a scale||Standard Deviation|Mean
1320840|NCT02282722|Secondary|Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team||3 months||||Participants|||Count of Participants
1320841|NCT02282722|Secondary|Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores|Satisfaction with communication during treatment decision-making process was assessed via 5 items from the Patient Assessment of Cancer Communication Experiences (PACE). Scores were averaged (“does not apply” excluded), creating a score of 1 to 4, with 4 being the most satisfied.|2 weeks||||units on a scale||Standard Deviation|Mean
1320842|NCT02282722|Secondary|Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process|Achievement of preferred role in decision-making was assessed by the Control Preferences Scale; patients indicate the role they played in their treatment decision which is compared to their preferred role (assessed at baseline).|2 weeks||||Participants|||Count of Participants
1320843|NCT02282722|Secondary|Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores|Decisional Conflict was assessed by a modified version of the 4 item SURE instrument of Legare at al which assesses whether patients 1) are sure of the best treatment option, 2) know the risks and benefits of their treatment options, 3) are clear about which risks and benefits matter to them, and 4) whether they have sufficient support to make their treatment decision. We expanded items 2 and 3 into four separate items assessing risks and benefits individually. Responses were summed, resulting in a scale of 0-6, where 0 indicates maximum conflict and 6 indicates no conflict|2 weeks||||units on a scale||Standard Deviation|Mean
1320844|NCT02282722|Secondary|Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy|Patients were asked “according to your doctor, what is the goal of the chemotherapy?” with the ability to choose any/all of the following response options: cure, control cancer growth, alleviate symptoms, prolong life, or other. Selecting either control cancer growth, and/or alleviate symptoms, and/or prolong life were defined as accurate understanding; “to cure” was considered inaccurate.|2 weeks||||Participants|||Count of Participants
1320845|NCT02282722|Secondary|Number of Patients With Accurate Understanding of Chemotherapy Risks|Patients were asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration, with separate items for nausea/vomiting, diarrhea, neuropathy, and hair loss. Patients' responses were correlated to the known side effect profile of their chemotherapy regimen and coded as accurate or inaccurate.|2 weeks||||Participants|||Count of Participants
1320846|NCT02282722|Primary|Number of Patients With Accurate Understanding of Chemotherapy Benefits|"Patients were asked How likely do you think that chemotherapy is to cure your cancer? with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of not at all likely was considered accurate. All other responses, including don't know, were considered inaccurate."|3 months||||Participants|||Count of Participants
1320847|NCT02282631|Secondary|Number of Participants Who Met Physical Activity Guidelines|"Number of participants who met physical activity guidelines, i.e. at least 60 minutes of moderate-to-vigorous physical activity (MVPA) a day, measured by accelerometer (ActiGraph GT3X+); cut points of intensity by Evenson et al (2008) (sedentary <100 counts per minute (cpm); light >100cpm; moderate >=2296cpm; vigorous >=4012cmp), epoch 10 seconds. Valid wear was at least 6h/day on at least 3 days (weekdays or weekends).~NOTE: the above criterion of 10h/day for at least 5 days was changed before the start of the fieldwork, although not on this website. We found studies which suggested that wearing the accelerometer 6h/day on at least three days, with or without weekend days, were sufficient to assess overall levels of physical activity. Consistent with these findings, this new minimum wear criterion was adopted in the present study."|9 weeks|14 participants in the control school (2 dropouts after baseline) and 15 in the intervention school (0 dropouts). Participants wore the accelerometer twice in the study, for one week each time. N of valid recordings= N children who met the minimum wear target (6h/day on at least 3 days) overall; only valid recordings were used to assess overall PA|||N children who met PA guidelines|N of valid recordings available overall||Number
1320848|NCT02282631|Primary|Parental ATS Reports by SMS|"Number of parental ATS reports by SMS.~In this case, for comparability with data from paper reports, one SMS reports refers to a week in which at least one SMS report was received from the parent.~Parental SMS reports were only possible in those weeks when the child was not wearing the accelerometer. Parents who had chosen to report ATS by SMS were requested to report by paper on the weeks when the child wore the accelerometer (once at baseline, and once at post-baseline), and could report ATS by SMS in all other weeks."|8 weeks after baseline|- 'One SMS report' refers to a week in which at least one SMS report of ATS was received from the parent throughout the study. The above 'number of units analyzed' refers to the total number of weeks, for all participants, in which parents could have reported ATS throughout the study.|||N weeks with at least one SMS reply|N weeks with at least one SMS reply||Number
1320860|NCT02282631|Primary|Number of Participants Who Returned Their Accelerometers on Time at the End of the Baseline Week|Number of participants who returned their accelerometer to the researcher on the designated day, at end of baseline week (all children wore the accelerometer at the same time)|1 week||||Participants|||Count of Participants
1320849|NCT02282631|Primary|Differences in MVPA During the Hour Before the Classes, Based on Child Report|differences in minutes of MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on child report (i.e. child reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.|||minutes of MVPA|trips to school|Standard Deviation|Mean
1320850|NCT02282631|Primary|Differences in MVPA During the Times Reported by the Parent, Based on Child Report|differences in minutes of MVPA between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on child report (i.e. child reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.|||minutes of MVPA|trips to school|Standard Deviation|Mean
1320851|NCT02282631|Primary|Differences in MVPA During the Hour Before the Classes, Based on Parental Report|differences in MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on parental report (i.e. parent reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.|||minutes of MVPA|trips to school|Standard Deviation|Mean
1320852|NCT02282631|Primary|Differences in MVPA During the Times Reported by the Parent, Based on Parental Report|differences in minutes of moderate-to-vigorous physical activity (MVPA) between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on parental report (i.e. parent reported whether the trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|"Trips to school reported, irrespective of the school where they were reported. No comparisons between control and intervention school due to the low number of non-active trips. Number of Participants Analyzed in the ATS Trips Arm is the total N of participants whose parents reported ATS and provided data for MVPA. Likewise for Non-ATS Trips."|||minutes of MVPA|trips to school|Standard Deviation|Mean
1320853|NCT02282631|Primary|Active Travel to School Based on Child Report|Percentage of active trips to school based on child report. This data is from all the trips reported by children, whether parental reports exist for the same day or not. For that reason, this differs from the number of trips reported in 'Agreement Between Parent and Child Reports' because in that case, both parent and child reports were required for the same day.|9 weeks (one week at baseline plus eight weeks after baseline)|Children in Year 5 (age 9-10); reports of ATS were collected from the parent and from the child at baseline (week 0) and weekly during the post-randomisation period (week 1 to 8); ATS trips=active trips to school. This data are only from child reports of ATS.|||% ATS trips|N trips to school reported by child||Number
1320854|NCT02282631|Primary|Active Travel to School Based on Parental Report|Active travel to school (ATS) refers to the behaviour of travelling to school by human-powered means as opposed to motorised transportation, for example by walking or cycling. This was based on parental ATS reports.|9 weeks (one week at baseline plus eight weeks after baseline)|Reports of ATS from parent and from child at baseline (week 0) and weekly during the post-randomisation period (week 1-8); ATS trips=active trips to school. This data is from all trips reported by the parent whether child ATS reports are available for the same days or not; this differs from N trips in 'Agreement Between Parent and Child Reports'|||% ATS trips|total N trips to school (parent-reported||Number
1320855|NCT02282631|Primary|Agreement Between Parent and Child Reports|"Inter-rater agreement between parent and child ATS* reports~*Active Travel to School"|9 weeks (one week at baseline plus eight weeks after baseline)||||Kappa score|N trips to school with both reports|95% Confidence Interval|Number
1320856|NCT02282631|Primary|Child ATS Reports Returned|"Number of child ATS* reports returned to the researcher (myself) throughout the study. Child ATS reports were always on paper.~*Active Travel to School"|9 weeks (one week at baseline plus eight weeks after baseline)|N of child ATS reports (always on paper) - is the total number of child ATS reports that could have been returned to the researcher throughout the study|||N child ATS reports returned|N of child ATS reports||Number
1320857|NCT02282631|Primary|Parental ATS Paper Reports Returned|"N parental ATS* paper reports returned to researcher(me)~*Active Travel to School~Paper reports with at least 1 box had been ticked out of the five boxes on the form (there was 1 box for each day of the week).~ATS reports were collected weekly, i.e. on the baseline week and on each of the eight post-baseline weeks. Accelerometers were only used twice; once at baseline (1week) and once at post-baseline (1week).~Parental paper ATS reports were preferred by 6 families, but on the 2 accelerometer weeks all participants had to use a paper reports including usual SMS respondents. In contr. group: all used paper reports at baseline (1st accel. week) (n=14), 6 usual paper respondents at post-baseline (6x8 weeks = 48), 6 SMS respondents who had to paper-report on the 2nd accel.week (both dropouts were SMS respondents & left too early for a 2nd accel.), so total N possible paper reports 14 + 48 + 6=68. Int. school: 15 participants & 8 usual paper respondents, total=15 + (8 x 8) + 7=86"|9 weeks (one week at baseline plus eight weeks after baseline)|The above number of participants corresponds to all participants in each group. The overall N of units analysed takes into account that although only some participants (6 in CG; 8 in IG) had chosen to report ATS by paper reports at baseline, everybody was expected to report by ATS paper report on the two weeks where the accelerometer was worn.|||N of parental ATS paper reports returned|N of parental ATS paper reports||Number
1320858|NCT02282631|Primary|Accelerometers Lost or Damaged|Number of accelerometers lost or damaged in this study|9 weeks (one week at baseline plus eight weeks after baseline)||||N of accelerometers lost or damaged|Total N times accelerometer was worn||Number
1320859|NCT02282631|Primary|Number of Participants Who Returned Their Accelerometers on Time at the End of the Post-baseline Week|Number of participants who returned their accelerometer on time to the researcher (myself) on the designated day, at end of post-baseline week. This was the second week of wear for participants. Whereas all participants were assessed concurrently at baseline, different subsamples were assessed every week at post-baseline.|8 weeks after baseline|Participants who stayed long enough in the study to wear the accelerometer a second time, at post-baseline|||Participants|||Count of Participants
1320861|NCT02282631|Primary|Retention of Participants|Number of participants who remained in the study until the end.|September 2014 to December 2014|There were 14 participants in the control school, and 15 participants in the intervention school, at baseline. In the post-baseline weeks, there were two dropouts in the control school, and none in the intervention school.|||N children retained for the whole study|||Number
1320862|NCT02282631|Primary|Recruitment of Participants|Number of participants recruited in this study.|Sep 2014 to December 2014|Number of participants approached to take part in the study|||N of children who took part in the study|||Number
1320863|NCT02282631|Primary|School Retention|% of schools who were retained for the whole duration of the study (out of the two who took part)|September 2014 to December 2014||||% schools retained for the whole study|||Number
1320864|NCT02282631|Primary|Schools Who Accepted to Take Part|Percentage of schools who accepted to take part in this study|May 2014 to June 2014|123 schools were approached; 4 accepted to take part but only 2 were selected to take part|||% schools who accepted to take part|||Number
1320865|NCT02282605|Secondary|The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests.||Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.||||participants|||Number
1320866|NCT02282605|Secondary|AUC of the Semi-quantitative SA Scores From Nasal Swabs|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Mean changes from baseline (0h) to each timepoint (Day 1,12 h; Day 2, 24 h: Day 3, 48h; Day 4, 84h; Day 7, 144h; Day 14, 312h) were calculated by treatment for the semi-quantitative SA scores. The AUC of the semi-quantitative SA scores were calculated for the two-day treatment period (AUC Day1- Day2); through the two day treatment period and up to discharge (AUC Day 1- Day4); and over the two-day treatment period, discharge and follow-up (AUC Day1- Day14). AUC was calculated by means of a trapezoidal rule using a standard algorithm. A higher AUC is indicative of a higher bacterial growth.|2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up|A comparison between treatment groups was performed separately for each AUC with an ANCOVA model with AUC as dependent variable, treatment as fixed effect and baseline SA (0 hours) as covariate. The AUC is a cumulative measure, comparison could be performed only within the same time period therefore data was normalised over time.|||units on a scale||Standard Deviation|Mean
1320867|NCT02282605|Secondary|Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score|The number of subjects with absence of SA from nasal swabs at the specified time-points..|Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose)||||participants|||Number
1320868|NCT02282605|Secondary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14.|Exploratory comparisons between active groups versus placebo of the percentage of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.|||participants|||Number
1320869|NCT02282605|Primary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).|Exploratory comparisons between active groups versus placebo of the number of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.|||participants|||Number
1320870|NCT02282527|Secondary|Number of Subjects With Immunogenicity Response|Blood samples for immunogenicity testing were collected at Weeks 1 (Baseline), 9, 17, and 20. Any samples that tested positive for alpha₁-PI antibodies were tested for neutralizing antibodies and antibody titer. Immunogenicity testing was performed using validated assays in a multitiered approach. Samples collected at Week 1 (Baseline) and at Weeks 9 and 20 were tested for immunogenicity while samples collected at Week 17 were to be tested for immunogenicity only if deemed appropriate (eg, unexpected PK profile).|Weeks 1, 9, 17, and 20||||Participants|||Count of Participants
1320871|NCT02282527|Secondary|AUC(0-7 Days) Based on Functional Activity|The exploratory PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC 0-7 days) using a functional activity assay of alpha₁-PI, at approximate steady state in subjects with AATD.|pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose||||mg*h/mL||Standard Deviation|Mean
1320872|NCT02282527|Primary|AUC(0-7 Days) Based on Antigenic Content|The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD.|pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose||||mg*h/mL||Standard Deviation|Mean
1320873|NCT02281773|Secondary|Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)|Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.|Baseline, Week 6 and Week 12|TS|||Unit on Scale||Standard Deviation|Mean
1320883|NCT02281591|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
1332622|NCT02057549|Secondary|Number of Participants Admitted to the Hospital After Emergency Department Visit||2 hours after study medication given||||Participants|||Count of Participants
1320874|NCT02281773|Secondary|Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom)|Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49.|Baseline and Week 12|This endpoint was not analysed because as per internal Boehringer Ingelheim rules, descriptive statistics are not calculated if data is available for less than 2/3rds of participants.||||||
1320875|NCT02281773|Secondary|Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment|Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patient’s overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms.|Up to 12 weeks|FAS|||Unit on Scale||Standard Deviation|Mean
1320876|NCT02281773|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment|Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patient’s severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.|||Unit on Scale||Standard Error|Least Squares Mean
1320877|NCT02281773|Secondary|Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment|Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patient's non missing responses. If >5 items were missing, the total score was missing.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.|||Unit on Scale||Standard Error|Least Squares Mean
1320878|NCT02281773|Primary|Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS)|"C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non−specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non−fatal suicide attempt, Completed suicide) or Self−injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are yes and no type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition."|Up to 12 weeks|TS (Number of subjects with a post baseline C−SSRS)|||Percentage of Participants|||Number
1320879|NCT02281773|Primary|Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS)|Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.|Baseline, Week 6 and Week 12|TS|||Unit on Scale||Standard Deviation|Mean
1320880|NCT02281773|Primary|Occurrence of Protocol-specified Adverse Events of Special Interest (AESI)|Occurrence of Protocol-specified adverse events of special interest (AESI).|Up to 20 weeks|The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.|||Percentage of Participants|||Number
1320881|NCT02281773|Primary|Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests)|Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests).|Up to 20 weeks|The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.|||Percentage of Participants|||Number
1320882|NCT02281773|Primary|Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment|MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as “learn and confirm” model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.|||Unit on Scale||Standard Error|Least Squares Mean
1321387|NCT02271477|Secondary|Time of Procedures|Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure|From time 0 to 30 minutes after spinal anesthesia||||minutes||Standard Deviation|Mean
1320884|NCT02281591|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
1320885|NCT02281591|Primary|Tmax - the Time of Occurrence of Cmax||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||hours||Standard Deviation|Mean
1320886|NCT02281591|Primary|Cmax - the Maximum Plasma Concentration||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||ng/mL||Standard Deviation|Mean
1320887|NCT02281526|Secondary|Cmax - Peak Plasma Concentration|Day 1 - Cmax Peak plasma concentration|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1320888|NCT02281526|Primary|Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).|"Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast).~BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites."|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.||||h·ng/mL||Standard Deviation|Mean
1320889|NCT02281448|Secondary|AUC0-t|AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.||||pg.h/mL||Standard Deviation|Mean
1320890|NCT02281448|Secondary|Tmax|Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.||||h||Standard Deviation|Mean
1320891|NCT02281448|Secondary|Cmax|Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.||||pg/mL||Standard Deviation|Mean
1320892|NCT02281448|Primary|Cmax - Maximum Observed Plasma BIA 2-194 Concentration|Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.|Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.||||ng/mL||Standard Deviation|Mean
1320893|NCT02281422|Primary|AUC(0-12h) - AUC From Time Zero to 12h|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites~AUC - area under the plasma concentration versus time curve"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.||||ng*h/mL||Standard Deviation|Mean
1320894|NCT02281422|Secondary|Tmax (hr) - Time at Which Cmax Occurred|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites~Cmax - maximum observed plasma drug concentration"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.||||hours||Standard Deviation|Mean
1320895|NCT02281422|Primary|Cmax - Peak Plasma Concentration|BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.||||ng/mL||Standard Deviation|Mean
1320896|NCT02281357|Secondary|Annual Asthma Exacerbation Rate (AAER) up to Week 40.|"AAER up to Week 40 in the tralokinumab group was compared to that seen in the placebo group. The response variable was the number of exacerbations the patient experienced up to Week 40, with the logarithm of the time at risk in years of experiencing an exacerbation included as offset in the model.~AAER = number of exacerbations*365.25/(follow-up date - date of randomisation + 1).~Asthma exacerbation was defined as a worsening of asthma that led to any of the following:~Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.~An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids.~An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma."|Baseline (Week 0) up to Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Adjusted rate (events/year)||95% Confidence Interval|Number
1320897|NCT02281357|Secondary|The Number of Patients With ≥50% Reduction in Final Average Daily OCS Dose at Week 40.|"The 40-week treatment period consisted of 3 phases: an induction phase (Week 0 to Week 12) where patients remained on their optimised OCS dose; an OCS reduction phase (Week 12 to Week 32) where OCS dose reduction could have started at Week 12 with the possibility of dose titration every 4 weeks to reach the lowest possible OCS dose; and a maintenance phase (Week 32 to Week 40) where patients remained on the OCS dose reached at Week 32 to demonstrate asthma control was maintained after achieving the lowest OCS dose.~The number of patients with ≥50% reduction in average daily OCS dose is presented. The final daily percent change from baseline was defined as {(Final daily average dose - baseline daily average dose)/baseline daily average dose}*100%. If this resulted in a value of -50% or less (more negative), that patient was classified as having at least a 50% reduction in final daily average OCS dose."|At Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
1320920|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
1320898|NCT02281357|Secondary|The Number of Patients With Final Daily Average OCS Dose ≤5 mg at Week 40.|"The 40-week treatment period consisted of 3 phases: an induction phase (Week 0 to Week 12) where patients remained on their optimised OCS dose; an OCS reduction phase (Week 12 to Week 32) where OCS dose reduction could have started at Week 12 with the possibility of dose titration every 4 weeks to reach the lowest possible OCS dose; and a maintenance phase (Week 32 to Week 40) where patients remained on the OCS dose reached at Week 32 to demonstrate asthma control was maintained after achieving the lowest OCS dose.~The number of patients with a final daily average OCS dose ≤5.0 mg is presented. For patients prescribed a fixed daily dose, then the average OCS dose was defined as the prescribed dose. For patients on a regimen where a different amount of OCS was to be taken each day, then the average OCS dose was defined as the average amount prescribed to be taken each day."|At Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
1320899|NCT02281357|Primary|Percent Change From Baseline in the Final Daily, Average, OCS Dose at Week 40 While Not Losing Asthma Control.|"The 40-week treatment period consisted of 3 phases: an induction phase (Week 0 to Week 12) where patients remained on their optimised OCS dose; an OCS reduction phase (Week 12 to Week 32) where OCS dose reduction could have started at Week 12 with the possibility of dose titration every 4 weeks to reach the lowest possible OCS dose; and a maintenance phase (Week 32 to Week 40) where patients remained on the OCS dose reached at Week 32 to demonstrate asthma control was maintained after achieving the lowest OCS dose. Criteria used to assess asthma control included lung function assessments (forced expiratory volume in 1 second and morning peak expiratory flow), night awakenings, and the use of rescue medication and systemic corticosteroids.~The least squares (LS) mean percent change from baseline in average daily OCS dose is presented. The final daily percent change from baseline was defined as {(Final daily average dose - baseline daily average dose)/baseline daily average dose}*100%."|Baseline (Week 0) and Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Percent change from baseline||Standard Error|Least Squares Mean
1320900|NCT02281318|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24|The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. ACQ-5 score is the mean score of 5 questions, each assessed on a 0-6 point scale to give a mean ranging between 0-6 with lower scores indicating better outcome. The five questions inquired about the frequency and/or severity of symptoms over the previous week. The response options for all these questions consisted of a zero (no impairment/limitation) to six (total impairment/limitation) scale. The mean change from Baseline was calculated as the value at Week 24 minus the Baseline value for each participant and analyzed using a mixed model repeated measures allowing for covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable), Baseline % predicted FEV1 and visit, plus interaction terms for visit by Baseline and visit by treatment group.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.|||Scores on a scale||Standard Error|Least Squares Mean
1320901|NCT02281318|Secondary|Percentage of Participants Achieving a 4 Point or Greater Reduction From Baseline in SGRQ Score at Week 24|The percentage of participants achieving a 4 point or greater reduction from Baseline in SGRQ (scored from 0-100 with lower scores indicating better outcome) at Week 24 was compared between treatment groups using a logistic regression model with covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and Baseline % predicted FEV1.|Baseline (Visit 2-latest pre-dose assessment) and Week 24|mITT Population. Participants with a missing Baseline covariate value were excluded from the analysis model.|||Percentage of participants|||Number
1320902|NCT02281318|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 24|FEV1 is the volume of air that can be forced out in one second after taking a deep breath. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline for each subject and was analyzed using a mixed model repeated measures adjusting for Baseline absolute pre-bronchodilator FEV1, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study and visit, plus interaction terms for visit by Baseline and visit by treatment group.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.|||Milliliters (mL)||Standard Error|Least Squares Mean
1320903|NCT02281318|Primary|Mean Change From Baseline (BL) in St. George’s Respiratory Questionnaire (SGRQ) Score at Week 24|SGRQ consisted of 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure Quality of Life in par. with diseases of airway obstruction, measuring symptoms, impact, and activity. Questions were completed by the par. with a recall over the past 4 weeks. SGRQ Total Score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100 to get a %. Change from BL in SGRQ was calculated as value at Week 24 minus value at BL for each par. and was analyzed using mixed model repeated measures allowing for covariates of BL value, region, BL maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1 and visit, plus interaction terms for visit by BL and visit by treatment group. Modified Intent-to-Treat (mITT) Population consisted of all randomized par. who received >= 1 dose of drug.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.|||Scores on a scale||Standard Error|Least Squares Mean
1320904|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4||||participants|||Number
1320938|NCT02280863|Secondary|Percentage of Time Within Glucose Range of 70-180 mg/dL||Up to 10 days|Participants who completed the protocol were included in the analysis.|||percentage of time in range||Standard Deviation|Mean
1320905|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
1320906|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||participants|||Number
1320907|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4||||participants|||Number
1320908|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
1320909|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||participants|||Number
1320910|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Week 4||||participants|||Number
1320911|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
1320912|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 Minutes after PDT||||participants|||Number
1320913|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT||||participants|||Number
1320914|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||participants|||Number
1320915|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4||||participants|||Number
1320916|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
1320917|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT||||participants|||Number
1320918|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||participants|||Number
1320919|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4||||participants|||Number
1320939|NCT02280863|Secondary|Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort|Median an glucose values are reported as assessed by fingerstick glucose meter value.|Up to 10 days|Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
1320921|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT||||participants|||Number
1320922|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||participants|||Number
1320923|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4||||participants|||Number
1320924|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24 hours post PDT#1|One subject did not have assessment performed|||participants|||Number
1320925|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||participants|||Number
1320926|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4||||participants|||Number
1320927|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 hours after PDT|One subject did not have assessment performed|||participants|||Number
1320928|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||participants|||Number
1320929|NCT02281136|Primary|The Terminal Exponential Half-life (T1/2,z)|The terminal slope will be calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.|1 day|T1/2,z could not be determined in 4 subjects|||hours||Geometric Coefficient of Variation|Geometric Mean
1320930|NCT02281136|Primary|AUCt|AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1320931|NCT02281136|Primary|Time at Which Cmax is Attained (Tmax) for ALA|Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day||||hours||Full Range|Median
1320932|NCT02281136|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA|Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples wiere taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.|1 day||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1320933|NCT02280863|Secondary|Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort||Up to 10 days|Data are presented for the Adult Cohort - Integrated System Interface and the Adolescent Cohort only. Participants who completed the protocol were included in the analysis.|||percentage of readings||Standard Deviation|Mean
1320934|NCT02280863|Secondary|Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface||Up to 10 days|Data are presented for the Adult Cohort - Medtronic Android Interface only|||percentage of readings||Inter-Quartile Range|Median
1320935|NCT02280863|Secondary|Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort||Up to 10 days|Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.|||percentage of time||Inter-Quartile Range|Median
1320936|NCT02280863|Secondary|Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts||Up to 10 days|Data are presented for adult cohorts only.|||percentage of time||Standard Deviation|Mean
1320937|NCT02280863|Secondary|Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL||Up to 10 days|Participants who completed the protocol were included in the analysis.|||percentage of tests||Standard Deviation|Mean
1320940|NCT02280863|Secondary|Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts|Mean glucose values are reported as assessed by fingerstick glucose meter value.|Up to 10 days|Data are presented for adult cohorts only.|||mg/dL||Standard Deviation|Mean
1320941|NCT02280863|Secondary|Mean Glucose Values|Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).|Up to 10 days|Participants who completed the protocol were included in the analysis.|||mg/dL||Standard Deviation|Mean
1320942|NCT02280863|Primary|Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness|"Our definition of a subject successfully participating in a cohort is:~No more than one meter glucose value <50 mg/dL and no values <40 mg/dL~No more than two episodes with meter glucose values remaining >300 mg/dL for more than 1 hour that are unrelated to an infusion set failure~No ketonemia >1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure~No seizures or loss of consciousness while system is on and functional"|Up to 10 days||||Participants|||Count of Participants
1320943|NCT02280811|Secondary|Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells|Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment.|one month after treatment|One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.|||% PD-1 circulating lymphocytes||Full Range|Mean
1320944|NCT02280811|Secondary|Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders|Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry.|One month after treatment|One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.|||percentage of cells||95% Confidence Interval|Mean
1320945|NCT02280811|Secondary|Number of Participants With a Dose Limiting Toxicity (DLT)|A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease.|19 months and 7 days||||Participants|||Count of Participants
1320946|NCT02280811|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|19 months and 7 days||||Participants|||Count of Participants
1320947|NCT02280811|Primary|Duration of Response|Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to one year||||months||95% Confidence Interval|Mean
1320948|NCT02280811|Primary|Objective Tumor Response Rate (Complete or Partial Response)|Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|4 years||||participants|||Number
1320949|NCT02280811|Primary|Maximum Tolerated Dose (MTD)|The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.|participants were followed for the duration of hospital stay, an average of 3 weeks||||# of cells x 10^11|||Number
1320950|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at 24 Hours After Transfusion|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter −24 hour diameter)/24 hour diameter × 100.|24 hours after transfusion||||percentage of brachial artery diameter||Standard Deviation|Mean
1320951|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at Baseline|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline||||percentage of brachial artery diameter||Standard Deviation|Mean
1320967|NCT02280187|Secondary|The Number of Adverse Events of Interest|An adverse event was considered an event of interest (AEI) if an adverse event was considered important to follow. These included reactions described in the EU product label, events monitored in the EU Risk Management Plan, events that were considered possible related to the treatment by the investigator, and events that had serious health consequences for patients (e.g. hospitalization).|12 months||||events|||Number
1320952|NCT02280499|Secondary|ASES Shoulder Score Index|The American Shoulder and Elbow Surgeon's (ASES) evaluation is used to document the improvement in pain, function and range of motion after shoulder injury. The ASES Shoulder Score Index is calculated from the ASES patient related questionnaire and ranges from 0-100 with a higher score indicating improvement in pain and function.|10Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The ASES Shoulder Score Index was calculated for 27 participants. As the score is a patient reported outcome the score could be completed at home increasing the number of available scores.|||units on a scale||Standard Deviation|Mean
1320953|NCT02280499|Secondary|Constant Murley Score|The Constant Murley Score is a shoulder outcome score to determine the functionality of the shoulder after the treatment of a shoulder injury. The score ranges from 0 to 100 with a higher score indicating better shoulder function.|10 Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The Constant Murley Score was incomplete for 3 participants and therefore the number of participants analyzed is 23.|||units on a scale||Standard Deviation|Mean
1320954|NCT02280499|Primary|Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components|The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.|up to 10 years||||Percentage survivorship||95% Confidence Interval|Number
1320955|NCT02280473|Secondary|Change From Baseline in the Schirmer Test|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||mm/5 min||Standard Deviation|Mean
1320956|NCT02280473|Secondary|Change From Baseline in the Combined Corneal and Conjunctival Staining Scores|The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||Scores on a Scale||Standard Deviation|Mean
1320957|NCT02280473|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||Seconds||Standard Deviation|Mean
1320958|NCT02280473|Secondary|Change From Baseline in the OSDI© Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Day 7|Intent-to-Treat: All randomized patients|||Scores on a Scale||Standard Deviation|Mean
1320959|NCT02280473|Primary|Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||Scores on a Scale||Standard Deviation|Mean
1320960|NCT02280226|Primary|Mean Blood Flow Measurement Under Apnea Using MRI|Blood flow pattern in subjects undergoing maximum apnea.|Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements||||ml/s||Standard Deviation|Mean
1320961|NCT02280226|Primary|Cardiac Function: Duration of Apnea|Alteration of cardiac function in subjects undergoing maximum apnea.|every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements||||sec||Standard Deviation|Mean
1320962|NCT02280187|Secondary|Fusion Rates in Subgroups|Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.|12 months||||percentage of participants|||Number
1320963|NCT02280187|Secondary|Fusion Status at the Last Assessment Performed by 12 Months|According to the study protocol, fusion status was determined to be either success or no success based on the images. If fusion failed at 1 level, the fusion was considered to be failed for the patient. The fusion rate at the last assessment is reported.|12 months|The subjects with the image that unable to determine fusion status and the assessment not done” were not taken into account.|||percentage of participants|||Number
1320964|NCT02280187|Secondary|The Number of Unplanned Secondary Spine Interventions in Subgroups|The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).|12 months||||participants|||Number
1320965|NCT02280187|Secondary|The Number of Subjects Having Secondary Spine Surgical Intervention|The number of subjects who had secondary spine surgical intervention at index level treated with InductOs and other level (either never treated or treated without InductOs) through 12 months is reported.|12 months||||participants|||Number
1320966|NCT02280187|Secondary|AEI Categorisation|The number of AEIs is presented by the categories predefined in the study protocol. The AEI MedDRA coded terms are presented in Section of serious adverse event.|12 months||||events|adverse event||Number
1320968|NCT02280187|Primary|Instrumentations Used for Stabilization|The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.|during surgery|The total levels in the summary are higher than total amount of levels because multiple answers are possible.|||spine level|Spine level||Number
1320969|NCT02280187|Primary|Supplemental Fixation|The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).|During surgery|The total levels across all the rows are higher than total number of levels analyzed because some levels may be represented in more than one rows.|||spine level|Spine level||Number
1320970|NCT02280187|Primary|Placement of the Matrix Wetted With InductOs|The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.|During surgery|The total levels across all the rows are higher than total number of levels analyzed because multiple answers are possible.|||spine level|Spine level||Number
1320971|NCT02280187|Primary|The Interbody Device Brand/Generic Names Used With InductOs|The number of spine levels with InductOs is presented by interbody brand/generic names.|during surgery||||spine level|Spine level||Number
1320972|NCT02280187|Primary|Primary Surgical Approaches Used for Implantation of InductOs|The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.|During surgery||||spine level|Spine level||Number
1320973|NCT02280187|Primary|Spine Levels Treated|The number of spine levels from the occiput to S1 is presented.|During surgery||||spine level|Spine level||Number
1320974|NCT02280187|Primary|The Primary Diagnostic Indication for InductOs Use|The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.|Baseline||||percentage of participants|||Number
1320975|NCT02280122|Primary|Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)|First off all patients rinsed with tap water for 30 seconds. Then they spat out the water and waited for 1 min. Now patients rinsed with 5ml of purified water for 30 seconds and spat this sample back into the test cup. Approximately 2 ml of the sampled saliva was now sampled with a syringe. After a filter was put onto the syringe 3 drops of the saliva were pressed through the filter into the ELISA kit. After 5 to 10 min the result was read from the test kit [21]. If both the control and test stripes were visible the respective test was positive (i.e. ≥ 25 ng aMMP 8 per ml). The clinical examiner (SIB) judged the results by simple visual inspection. Already a faint test stripe was judged as positive test. All test results were photographed with 2fold magnification. All images of the test were then evaluated by a second examiner (PE) who was blinded for the clinical diagnoses.|5 minutes||||percentage of true cases (sens./spec.)||95% Confidence Interval|Number
1320976|NCT02279862|Secondary|Prostate Specific Antigen Response Rate|PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown.|From baseline to PSA response (assessed up to December 2016, approximately 48 months)|All randomized participants|||Participants|||Count of Participants
1320977|NCT02279862|Secondary|Time to Pain Progression|Pain progression was defined as an increase in BPI-SF pain Item #3 score of >= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown.|From randomization until pain progression (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
1320978|NCT02279862|Secondary|Prostate Specific Antigen Progression-free Survival (PSA PFS)|Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown.|From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
1320979|NCT02279862|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown.|From randomization to death from any cause (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
1320980|NCT02279862|Primary|Radiographic Progression-free Survival (rPFS)|rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.|From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
1320981|NCT02279862|Secondary|Number of Participants Who Experienced Immune-related Adverse Events (irAEs)|The total number of participants with immune-related adverse events of any grade is reported for each arm.|From first dose of ipilimumab to last dose plus 90 days|All treated participants|||Participants|||Count of Participants
1320982|NCT02279667|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||ng*h/mL||Standard Deviation|Mean
1320983|NCT02279667|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||ng*h/mL||Standard Deviation|Mean
1320984|NCT02279667|Primary|Tmax - the Time of Occurrence of Cmax|Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||hours||Full Range|Median
1320985|NCT02279667|Primary|Cmax - the Maximum Plasma Concentration|Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1320986|NCT02279641|Primary|Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)|Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol|22 days||||ug||95% Confidence Interval|Geometric Mean
1320987|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of RDEA3170 Alone and In Combination with Allopurinol|22 days||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1320988|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol|22 days||||μg*hr/mL||95% Confidence Interval|Geometric Mean
1320989|NCT02279641|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax of RDEA3170 Alone and In Combination with Allopurinol|22 days||||ng/mL||95% Confidence Interval|Geometric Mean
1320990|NCT02279641|Secondary|Incidence of Treatment-Emergent Adverse Events||22 days||||Number of participants|||Number
1320991|NCT02279641|Primary|Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine||22 days||||Percentage (%)||Standard Error|Mean
1320992|NCT02279641|Primary|Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)|CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination|22 days||||mL/min||95% Confidence Interval|Geometric Mean
1320993|NCT02279641|Primary|Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)|Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||mg||95% Confidence Interval|Geometric Mean
1320994|NCT02279641|Primary|Apparent Terminal Half-life (t1/2)|t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination|22 days||||hr||95% Confidence Interval|Geometric Mean
1320995|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||μg·hr/mL||95% Confidence Interval|Geometric Mean
1320996|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||μg·hr/mL||95% Confidence Interval|Geometric Mean
1320997|NCT02279641|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination|22 days||||hr||Full Range|Median
1320998|NCT02279641|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||μg/mL||95% Confidence Interval|Geometric Mean
1320999|NCT02279498|Secondary|Coefficient of Nitrogen Absorption (CNA)|Change from baseline in coefficient of nitrogen absorption|Baseline, 7 weeks|Analysis population evaluates observed case data without multiple imputation for missing values|||percent of nitrogen ingested||Standard Deviation|Mean
1321000|NCT02279498|Secondary|Coefficient of Fat Absorption (CFA)|Change from baseline in coefficient of fat absorption|Baseline, 7 weeks|Analysis population evaluates observed case data without multiple imputation for missing values|||fat absorbed as % of fat ingested||Standard Deviation|Mean
1321001|NCT02279498|Primary|Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline|The primary endpoint evaluates the difference between treatment arms in change from baseline in coefficient of fat absorption (CFA). As such, descriptive statistics for individual treatment arms are not provided in this measure, but are reported in the secondary endpoints|Baseline, 7 weeks|Analysis population evaluates all subjects who received at least one dose of study drug. Missing Visit 7 CFA values were multiply imputed using baseline CFA, baseline BMI, sex, age, acid suppression usage, and region.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1321002|NCT02279420|Primary|Mean Percent Total Body Weight Loss|Percent total body weight loss calculated through 12 months post procedure|1 Year||||percentage of TBW||Standard Deviation|Mean
1321003|NCT02279407|Secondary|Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)|To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.|||ratio of % liver fat||95% Confidence Interval|Geometric Mean
1321039|NCT02278146|Primary|Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study|Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.|up to 3 weeks||||participants|||Number
1321284|NCT02273323|Secondary|Diastolic Blood Pressure Sitting|Diastolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
1321004|NCT02279407|Primary|Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)|To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.|||ratio of % liver fat||95% Confidence Interval|Geometric Mean
1321005|NCT02279108|Secondary|Number of Patients With ICG Allergy|allergy is : redness, edema, itching, larynges edema and/or allergic shock|Month 2||||Participants|||Count of Participants
1321006|NCT02279108|Secondary|Number of Patients With ICG Allergy|allergy is : redness, edema, itching, larynges edema and/or allergic shock|1 hour after the end of the surgery||||Participants|||Count of Participants
1321007|NCT02279108|Secondary|Number of Patients With ICG Allergy|allergy is : redness, edema, itching, larynges edema and/or allergic shock|peroperative||||Participants|||Count of Participants
1321008|NCT02279108|Secondary|Comparison Between Groups of Time Surgery Node|time from incision time to the last node surgery|Peroperative||||minuts||Inter-Quartile Range|Median
1321009|NCT02279108|Secondary|Time From Injection of One Dose ICG Injection to Incision Time|time from injection of one dose ICG injection to incision time|Peroperative||||minutes||Inter-Quartile Range|Median
1321010|NCT02279108|Secondary|Comparison Between Groups of Anesthesia Time|time from the injection of anesthesic to the waking|Peroperative||||minutes||Full Range|Median
1321011|NCT02279108|Secondary|Comparison Between Groups of the Time of the Surgery|time from incision to wound closure|Peroperative||||minuts||Inter-Quartile Range|Median
1321012|NCT02279108|Secondary|Number of Lymph Nodes ICG Negative and Tc Positive|Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive|Peroperative||||lymph nodes|lymph nodes||Number
1321013|NCT02279108|Secondary|Number of Lymph Nodes ICG Positive and Tc Negative|Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative|Peroperative||||lymph nodes|Lymph nodes||Number
1321014|NCT02279108|Secondary|Number of Lymph Nodes ICG Positive and Tc Positive|Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive|Peroperative||||lymph nodes|lymph nodes||Number
1321015|NCT02279108|Primary|Number of Patients With Less Than Two Lymph Nodes Detected|Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone|peroperative||||Participants|||Count of Participants
1321016|NCT02279082|Primary|Number of Participants With Treatment Emergent Adverse Events||6 months||||Participants|||Count of Participants
1321017|NCT02278939|Secondary|Change in Body Mass Index (BMI)|Change in body mass index per group|Baseline to 3 months|Overweight/obese English-speaking Filipino American adults, were randomized either to the Intervention group (received a combination of mobile app, social media and in-person diabetes prevention intervention) or the active control group.|||kg/m^2||Standard Deviation|Mean
1321018|NCT02278939|Secondary|Percent of Weight|Percent of weight change from baseline to 3-months by group|Baseline to 3 months|Overweight/obese English-speaking Filipino American adults were randomized either to the Intervention group or the active control.|||percent of weight||Standard Deviation|Mean
1321019|NCT02278939|Secondary|Weight Change in Kilogram|Weight change in kilogram by group|Baseline to 3 months|Overweight/obese English-speaking Filipino American adults were randomized in a 1:1 ratio either to the intervention group or active control group.|||kilograms||Standard Deviation|Mean
1321020|NCT02278939|Primary|Number of Participants Who Completed the Study|Able to recruit and enroll the participant sample size goal and at least 85% of participants enrolled complete the study program|Baseline to 6-months|Eligible participants enrolled and randomized =67. Sixty-one participants completed the study: Intervention group =28; Active Control = 33. A multi-level regression analysis with intention-to-treat was performed which accounted for missing data. Feasibility will be measured/considered > 85% completion and retention rate. Study feasibility was 91%|||participants|||Number
1321021|NCT02278783|Secondary|Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response)|To determine the frequency of clinical benefit (stable disease, partial, and complete response) according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria|Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months|Study was terminated early, no analysis performed.||||||
1321022|NCT02278783|Secondary|Estimate Progression Free Survival|To estimate progression free survival for patients treated with this regimen|At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months|Study was terminated early, no analysis performed.||||||
1321023|NCT02278783|Primary|Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported.|Patients will remain on treatment for approximately 4-6 months on average.||||participants|||Number
1321024|NCT02278783|Primary|6 Month Progression Free Survival (PFS)|To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers|Patients will be checked for PFS after 6 months on treatment||||participants|||Number
1321040|NCT02278003|Secondary|Memory Threshold|At the presentation of each picture, the child will be asked whether or not he/she remembers having seen it previously. Each response will be coded as correct (true positives and true negatives) or incorrect (false positives and false negatives).|1 year||||Hit rate||Standard Deviation|Mean
1321285|NCT02273323|Secondary|Systolic Blood Pressure Sitting|Systolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
1321025|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.|||percentage of participants||95% Confidence Interval|Number
1321026|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.|||percentage of participants||95% Confidence Interval|Number
1321027|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.|||percentage of participants||95% Confidence Interval|Number
1321028|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.|||percentage of participants||95% Confidence Interval|Number
1321029|NCT02278614|Primary|Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye|"the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye.~Two relevant time points are considered for this primary criteria: D0 and Day 84."|Day 84|"The primary efficacy analysis (mean change in IOP from baseline to Day 84) was performed on the mITT set (236 patients).~mITT set: All ITT patients with at least one baseline and one post-randomisation efficacy assessment following study treatment.~242 patients described in the participant flow correpsond to the ITT & Safety set."|||mm Hg||Standard Error|Least Squares Mean
1321030|NCT02278562|Secondary|Change in Skeletal Muscle Net Protein Balance|Skeletal muscle net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the skeletal muscles.|baseline and 3 months|The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.|||μg/100 ml/min||Inter-Quartile Range|Median
1321031|NCT02278562|Secondary|Change in Whole-body Net Protein Balance|Whole-body net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the whole body|baseline and 3 months|The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.|||mg/kg/min||Inter-Quartile Range|Median
1321032|NCT02278562|Primary|Change in Leucine Disposal Rate (LDR)|LDR is a sensitive laboratory assessment of amino acid metabolism|baseline and 3 months|The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.|||mg/kg/min||Inter-Quartile Range|Median
1321033|NCT02278484|Secondary|Number of Subjects Who Undergo a Revision or Additional Surgery During the Study|Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported|Procedure-6 month follow up|All participants|||Participants|||Count of Participants
1321034|NCT02278484|Secondary|Change in Quality of Life From Baseline Through Completion|Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score.|Baseline to 6-month follow-up|All participants|||Units on a scale||Standard Deviation|Mean
1321035|NCT02278484|Primary|Complications|Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.|Index procedure through 3-month follow-up|All participants|||participants|||Number
1321036|NCT02278484|Primary|Technical Success: Sinuses Successfully Treated With Balloon Dilation|Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.|Index procedure|All sinus dilations attempted in all participants|||sinus dilation attempts|Sinuses||Number
1321037|NCT02278146|Secondary|Overactive Bladder Arm|Percentage of participants with less daily voids from baseline to 3 weeks.|up to 3 weeks||||percentage of participants|||Number
1321038|NCT02278146|Secondary|Stress Incontinence Arm|Percentage of participants with less daily leaks from baseline to 3 weeks.|up to 3 weeks||||percentage of subjects|||Number
1321041|NCT02278003|Primary|Sedation Threshold|During the 10-minute infusion of propofol, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task.|1 year||||Participants|||Count of Participants
1321042|NCT02277769|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
1321043|NCT02277769|Secondary|Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set which included all randomized participants who received any study drug, and was analyzed based on the treatment received.|||percentage of participants|||Number
1321044|NCT02277769|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment|Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
1321045|NCT02277769|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321046|NCT02277769|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321047|NCT02277769|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321048|NCT02277769|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321049|NCT02277769|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321100|NCT02277119|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Measurements|RNFL thickness measured|1 Hour||||Microns||Standard Deviation|Mean
1321050|NCT02277769|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321051|NCT02277769|Secondary|Change From Baseline in Percent Body Surface Area (BSA) to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of body surface area||Standard Deviation|Mean
1321052|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of particpants|||Number
1321053|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
1321054|NCT02277769|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321055|NCT02277769|Secondary|Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321056|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
1321057|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.|Baseline to Week 4|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
1321058|NCT02277769|Secondary|Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321101|NCT02277119|Primary|Optic Disc Measurements (Optic Disc Size)|Reporting of the Optic Disc Size difference between the Maestro and iVue|1 Hour||||Mircrons squared||Standard Deviation|Mean
1321059|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.|||percentage of participants|||Number
1321060|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
1321061|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|Week 16|Full analysis set included all randomized participants.|||percentage of participants|||Number
1321062|NCT02277769|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of “0” or “1” and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.|Week 16|Full analysis set included all randomized participants.|||percentage of participants|||Number
1321063|NCT02277743|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
1321064|NCT02277743|Secondary|Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
1321065|NCT02277743|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment|Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
1321102|NCT02277093|Secondary|Overall Survival (OS)|-The follow-up time for OS was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016.|Through completion of follow-up (median follow-up was 6.61 months)||||months||95% Confidence Interval|Median
1321066|NCT02277743|Secondary|Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321067|NCT02277743|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321068|NCT02277743|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321069|NCT02277743|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321070|NCT02277743|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321071|NCT02277743|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321072|NCT02277743|Secondary|Change From Baseline in Percent Body Surface Area (BSA) to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of body surface area||Standard Deviation|Mean
1321073|NCT02277743|Secondary|Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
1321074|NCT02277743|Secondary|Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
1321075|NCT02277743|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321103|NCT02277093|Secondary|Time to Progression (TTP)||Through completion of follow-up (median follow-up was 6.61 months)|Only patients who had their first measurement scans were evaluable for this outcome measure.|||months||Standard Deviation|Mean
1321076|NCT02277743|Secondary|Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1321077|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
1321078|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and subjects with missing peak NRS at Week 4 were considered as non-responders.|Baseline to Week 4|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
1321079|NCT02277743|Secondary|Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
1321080|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.|||percentage of participants|||Number
1321081|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
1321082|NCT02277743|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
1321083|NCT02277743|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points at Week 16|"IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders."|Week 16|Full analysis set included all randomized participants.|||percentage of participants|||Number
1324312|NCT02205801|Secondary|Total Pain Medication Utilization|Total operative opioid dosages administered converted to effective mg of Hydromorphine.|At follow up appointment 1-2 weeks postoperatively||||mg||Standard Deviation|Mean
1321084|NCT02277691|Secondary|Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit|The change in home morning SPB and DBP measured at End of Week 12, End of Treatment (Up to Week 52) relative to baseline.|Baseline (End of Run-in Period, Week 0), End of Week 12 and End of Treatment (Up to Week 52)|The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analysed at the given time­point.|||mmHg||Standard Deviation|Mean
1321085|NCT02277691|Secondary|Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit|The change in office trough SBP and DBP measured at Weeks 12 last observation was carried forward (LOCF) and 52 (LOCF) relative to baseline. Sitting blood pressure was measured at least 3 times. Each measurement session ended once blood pressure was found stable at 2 consecutive measurements. The average of the last 2 measurements of office sitting blood pressure was used.|Baseline (End of Run-in Period, Week 0) and Weeks 12 (LOCF) and 52 (LOCF)|The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analyzed at the given timepoint.|||mmHg||Standard Deviation|Mean
1321086|NCT02277691|Primary|Number of Participants With Markedly Abnormal Clinical Laboratory Tests|The number of participants with any markedly abnormal clinical laboratory test values collected throughout study. RBC = Red blood cells, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit. Laboratory vallues were considered abnormal if they were beyond the values defined in categories.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
1321087|NCT02277691|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG)|Reported TEAE is categorized into cardiac disorders and investigations system organ class (SOC) related to ECG.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
1321088|NCT02277691|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Body Weight|Reported TEAE is categorized into investigations System Organ Class (SOC) related to body weight.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
1321089|NCT02277691|Primary|Number of Participants With Markedly Abnormal Vital Signs Values|Vital signs included supine and standing systolic and diastolic blood pressure (SBP and DBP) respectively and office sitting pulse. Vital signs were considered abnormal if they were beyond the values defined in categories.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
1321090|NCT02277691|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
1321091|NCT02277639|Primary|Number of Participants With Engraftment|The primary objective is to determine event free survival with durable stable engraftment of donor cells at one year.|One Year||||Participants|||Count of Participants
1321092|NCT02277626|Primary|Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest|Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)|End of study visit per intervention||||units on a scale||Full Range|Mean
1321093|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
1321094|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
1321095|NCT02277626|Secondary|Dry Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry|End of study visit per intervention||||gram||Full Range|Mean
1321096|NCT02277626|Primary|Wet Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion|End of study visit per intervention||||grams||Full Range|Mean
1321097|NCT02277249|Primary|Patient Discomfort With Digoxin Injection (Pain Score)|"Pain score (indicated by patient reporting pain level from 0 (no hurt) to 5 (hurts worst) at time of digoxin injection)"|At time of study (immediate)||||Units on a scale||Standard Deviation|Mean
1321098|NCT02277119|Primary|Optic Disc Measurement (Cup Size)|Reporting of the Cup size difference between the Maestro and iVue|1 Hour||||Microns cubed||Standard Deviation|Mean
1321099|NCT02277119|Primary|Full Retinal Thickness Measurement|Full Retinal Thicknesses Measurement|1 Hour|Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.|||Microns||Standard Deviation|Mean
1321104|NCT02277093|Secondary|Overall Response Rate (ORR)|"The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.~Using RECIST 1.1~The follow-up time was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016."|Through completion of follow-up (median follow-up was 6.61 months)||||Participants|||Count of Participants
1321105|NCT02277093|Secondary|Toxicity Profile and Tolerability as Measured by Reportable Adverse Events|"The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.~Reportable adverse events will be tracked for 28 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events that are greater than or equal to grade 2 and are considered possibly, probably, or definitely related to study treatment."|Up to 28 days following last day of study treatment||||adverse event|||Number
1321106|NCT02277093|Primary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.~Progression - at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Through completion of follow-up (median follow-up was 6.61 months)||||months||Inter-Quartile Range|Median
1321107|NCT02276612|Secondary|Change From Baseline in CD4 Percentage at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||percentage||Standard Deviation|Mean
1321108|NCT02276612|Secondary|Change From Baseline in CD4 Percentage at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with on-treatment data were analyzed.|||percentage||Standard Deviation|Mean
1321109|NCT02276612|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
1321110|NCT02276612|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
1321111|NCT02276612|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1321112|NCT02276612|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1321113|NCT02276612|Primary|Incidence of Treatment-Emergent Adverse Events|The percentage of participants experiencing any treatment-emergent adverse event was summarized.|Up to Week 48|Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1321114|NCT02276612|Primary|Incidence of Treatment-Emergent Serious Adverse Events|The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.|Up to Week 48|Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1321115|NCT02276560|Primary|Rate of N2 Nodal Clearance|N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance|3 Months|The only patient registered before funding was withdrawn could not complete treatment due to adverse events.||||||
1321116|NCT02276274|Secondary|Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)|Laboratory assessments included hematology, serum chemistry and urinalysis. Any laboratory-related TEAE reported at any time point were reported in this measure.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
1321117|NCT02276274|Secondary|Number of Participants With Significant Change From Baseline in Electrocardiograms|Clinically significant change in electrocardiograms observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
1321118|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Body Weight|Clinically significant change participant's body weight observed at any time point are reported.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
1321119|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (infra-axillary), supine blood pressure resting more than 5 minutes (systolic and diastolic [Millimeters of mercury]), respiratory rate and pulse (beats per minute). Clinically significant change in vital signs observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
1323606|NCT02220764|Other Pre-specified|Number of of Fixed Dental Prostheses (FDPs) With Rough Surface|Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.|3 years||||FDPs with rough surface|||Number
1321120|NCT02276274|Secondary|Number of Participants Reporting 1 or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to the day of discharge (Day 4) in the second intervention period|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
1321121|NCT02276274|Secondary|Tmax: Time to Reach Emax|Time to reach Emax for the first time was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||hour||Full Range|Median
1321122|NCT02276274|Secondary|Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity|Maximum inhibition rate of plasma DPP-4 activity was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||percentage of inhibition||Standard Deviation|Mean
1321123|NCT02276274|Secondary|AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours|Area under the inhibition rate of plasma DPP-4 activity-time curve from time 0 to 24 hours was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||percentage of inhibition*hour||Standard Deviation|Mean
1321124|NCT02276274|Secondary|DPP-4 Activity|DPP-4 activity was assessed from the plasma samples collected from the participants.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||nanomole/minute/milliliter (nmoL/min/mL)||Standard Deviation|Mean
1321125|NCT02276274|Secondary|Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity|DPP-4 activity and inhibition rate of DPP-4 activity was assessed from the plasma samples collected from the participants. Inhibition of DPP-4 enzyme was used to determine the antihyperglycemic activity of the investigational product.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||percentage of inhibition||Standard Deviation|Mean
1321126|NCT02276274|Primary|CLr: Renal Clearance of Metformin|CLr is a measure of apparent clearance of the drug from the urine.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
1321127|NCT02276274|Primary|CLr: Renal Clearance of SYR-322Z|CLr is a measure of apparent clearance of the drug from the urine. The clearance is the rate at which waste substances are cleared from the blood.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
1321128|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321129|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321130|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321131|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321132|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321286|NCT02273323|Secondary|Diastolic Blood Pressure Supine|Diastolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
1321133|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 24 hours post dose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321134|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321135|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321136|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321137|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321138|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
1321139|NCT02276274|Primary|Mean Residence Time (MRT) for Metformin|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
1321140|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
1321141|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for Metformin|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
1321142|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for Metformin|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr^-1||Standard Deviation|Mean
1321143|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1321144|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Metformin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Full Range|Median
1321145|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for Metformin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1321222|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 12|Participants with a positive anti-etanercept antibody binding response at week 12|||percentage of participants||95% Confidence Interval|Number
1321146|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: Subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
1321147|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1321148|NCT02276274|Primary|AUC (0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin|AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1321149|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Standard Deviation|Mean
1321150|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Standard Deviation|Mean
1321151|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr^-1||Standard Deviation|Mean
1321152|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng*hr/mL||Standard Deviation|Mean
1321153|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Full Range|Median
1321154|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng/mL||Standard Deviation|Mean
1321155|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Standard Deviation|Mean
1321167|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||nanogram*milliliter per hour (ng*hr/mL)||Standard Deviation|Mean
1321156|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng*hr/mL||Standard Deviation|Mean
1321157|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng*hr/mL||Standard Deviation|Mean
1321158|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
1321159|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322Z|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). (AUMC [0-inf]) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
1321160|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).|3 hours prior to administration, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours after administration|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
1321161|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322Z|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
1321162|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr^-1||Standard Deviation|Mean
1321163|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1321164|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hour (hr)||Full Range|Median
1321165|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322Z|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1321166|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
1321180|NCT02275767|Primary|% Vital Bone Formation (Histological)|histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation||||percentage of total area||Standard Deviation|Mean
1334072|NCT02029521|Primary|Height Percentile|Height Percentile adjusted for sex and age|3 months|All participants.|||Percentile adjusted for age and sex||Standard Deviation|Mean
1321168|NCT02276222|Secondary|Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects|"Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment.~Values affected by other medication use were to be set to missing."|Up to Week 48|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1321169|NCT02276222|Secondary|Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke|All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.|up to week 48|Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.|||event per 1000 person years|||Number
1321170|NCT02276222|Secondary|Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke|All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.|Up to 48 Weeks|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
1321171|NCT02276222|Secondary|Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke|All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs “myocardial infarction”, “other ischemic heart disease”, “central nervous system hemorrhages and cerebrovascular conditions”) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
1321172|NCT02276222|Primary|Percentage of Subjects Who Discontinue the Study Due to TEAE|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to 48 Weeks|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
1321173|NCT02276222|Primary|Number of Subjects Who Discontinue the Study Due to TEAE|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
1321174|NCT02276222|Primary|Percentage of Subjects With Treatment-emergent Serious Adverse|A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
1321175|NCT02276222|Primary|Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)|A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
1321176|NCT02276222|Primary|Percentage of Subjects With Treatment-emergent Adverse Events|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
1321177|NCT02276222|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
1321178|NCT02276040|Primary|Change in Blood Serum Levels of Bupivocaine From Baseline|Bupivocaine levels measured in the blood that is collected in a surgical drain post surgery. Blood samples will be tested for change in serum bupivicaine levels from baseline.|Change from baseline at 2 and 5 hours post-dose||||ug/cc||Inter-Quartile Range|Median
1321179|NCT02275767|Secondary|% Residual Graft Material (Histological)|histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation||||percentage of total area||Standard Deviation|Mean
1321181|NCT02275611|Secondary|Change in Percentage Heavy Drinking Days|A heavy drinking day is defined by consumption of 5 or more standard drinks for men, 4 or more standard drinks for women. The outcome measure is the change in percentage of heavy drinking days as determine by the Timeline Followback interview between the baseline 90 day period and the first 4 weeks of intranasal test treatment in the outpatient setting.|90 days prior to admission and 4 weeks in the outpatient setting|This assessment was done only in the outpatient phase.|||percentage of heavy drinking days change||Standard Deviation|Mean
1321182|NCT02275611|Secondary|Total mg of Lorazepam for Detoxification|"Cumulative lorazepam received (2 mg doses)~After initiation of test treatments, CIWA scores and vital signs were obtained every 4 hours or whenever subjects or staff reported/observed significant increases in symptoms. Lorazepam (2 mg dose) was given if CIWA scores were >7, diastolic blood pressure rose to >120, or heart rate rose to >110. An additional 2 mg was given 1 hour after each lorazepam dose if CIWA scores and/or vital signs remained elevated."|48 hours after initiation of intranasal test doses|This assessment was done only in the inpatient withdrawal phase.|||cumulative lorazepam doses (mg)||Standard Deviation|Mean
1321183|NCT02275611|Primary|Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score|The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).|Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments|This assessment was done only in the inpatient withdrawal phase.|||units on a scale||Standard Deviation|Mean
1321184|NCT02275546|Primary|Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion|Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.|Up to 48 hours after vaginal ring insertion|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
1321185|NCT02275546|Primary|Percentage of Participants With Successful Ring Insertion|Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.|Day 1 (immediately after vaginal ring insertion)|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
1321186|NCT02275481|Primary|Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.|Up to 90 days|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol.||||||
1321187|NCT02275364|Secondary|VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 2 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.|||Units on a scale||Standard Deviation|Mean
1321188|NCT02275364|Secondary|Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 30 minutes|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.|||Units on a scale||Standard Deviation|Mean
1321189|NCT02275364|Secondary|Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)|"Regional measures of breathing-related cortical activity were derived by determining Functional Connectivity and Event-related percentage signal change.~Functional connectivity analyzes of fMRI data where spontaneous (i.e. while the participant is at rest) signal changes in one brain region are regressed against other regions, to identify regions sharing similar functional properties.~Event-related functional magnetic resonance imaging (efMRI) detects changes in the BOLD hemodynamic response to neural activity associated with certain event. In this case, the events were pre-defined by collecting additional data during the scan; participant respiration was determined using a simple pressure-sensitive respiration belt. Events time-locked to peak inspiration and expiration were defined separately, and regressed against brain activity, showing brain regions that were more or less active during each event type."|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was prespecified to evaluate the effect on nasal strips on the breathing related brain activity without the use of nasal decongestant|||% signal change||Standard Deviation|Mean
1321190|NCT02275364|Primary|Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)|Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to evaluate the effect on nasal strips on the measure of brain activity without the use of nasal decongestant.|||% signal change||Standard Deviation|Mean
1321191|NCT02275364|Primary|Anatomical Measures: Volume (Multiple Volume Reading)|Determination of averaged volume reading during the MRI (Average of 8 sub-regions)|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.|||mm^3||Standard Deviation|Mean
1321192|NCT02275364|Primary|Cerebral Blood Flow (CBF)|CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject’s whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject’s T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not evaluated in this outcome measure as it was pre-specified to to analyze effect of nasal strips on the cerebral blood without the use of nasal decongestant.|||ml/100g/min||Standard Deviation|Mean
1321193|NCT02275364|Primary|Anatomical Measure: Volume (Single Volume Reading)|Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.|||mm^3||Standard Deviation|Mean
1321194|NCT02275364|Primary|Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task|Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to analyze effect on nasal strips on the brain activity without the use of nasal decongestant|||% Signal||Standard Deviation|Mean
1321195|NCT02275364|Primary|Anatomical Measures : Cross Sectional Area|Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.|||mm^2||Standard Deviation|Mean
1321196|NCT02275156|Secondary|Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)|"Serum PCSK9 concentrations were determined using a qualified ELISA. The LLOQ of the assay was 15 ng/mL.~Log-transformed baseline PCSK9 was included in the model as a covariate and participant as a random effect."|Baseline and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set|||percent change||95% Confidence Interval|Geometric Mean
1321197|NCT02275156|Secondary|Area Under the Effect Curve From Baseline to Day 57 (AUECday1-57) for Low-density Lipoprotein Cholesterol (LDL-C)|The derived log-transformed AUECday1-57 for direct LDL-C was analyzed using a mixed-effect analysis of variance model. Log-transformed baseline LDL-C was the covariate.|4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set|||mg/dL*day||95% Confidence Interval|Geometric Mean
1321198|NCT02275156|Secondary|Number of Participants With Anti-evolocumab Antibodies|Blood samples were tested using an electrochemiluminescence-based bridging immunoassay to detect antibodies capable of binding to evolocumab.|57 days|Safety analysis set|||participants|||Number
1321199|NCT02275156|Secondary|Number of Participants With Clinically Relevant Vital Sign or Clinical Laboratory Changes|The investigator reviewed vital signs and laboratory test results and determined whether an abnormal value in an individual participant represented a clinically significant change from the participant’s baseline values.|57 days|Safety analysis set|||participants|||Number
1321200|NCT02275156|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal;~life threatening (places the participant at immediate risk of death);~requires in patient hospitalization or prolongation of existing hospitalization;~results in persistent or significant disability/incapacity;~congenital anomaly/birth defect;~other medically important serious event.~The investigator assessed whether each adverse event was possibly related to the study drug."|From the first dose of study drug up until Day 57|Safety analysis set (all participants who received at least 1 dose of study drug)|||participants|||Number
1321201|NCT02275156|Primary|Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) for Evolocumab||Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|PK analysis set|||day*μg/mL||Standard Deviation|Mean
1321202|NCT02275156|Primary|Maximum Observed Serum Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.|Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Pharmacokinetic (PK) analysis set (all participants for whom at least 1 PK parameter could be adequately estimated)|||μg/mL||Standard Deviation|Mean
1321203|NCT02275052|Secondary|Change From Baseline in Inspiratory Capacity (IC) 3 Hours Post-dose at Week 12 of Each Treatment Period|IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Standard body plethysmography techniques were used for lung volumes. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period. Mean Baseline is the mean of the Baselines for each par. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each par. IC 3-hours post-dose was measured from the value obtained 3 hours after dosing on Day 2 and Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit (Day 2 or Week 12), smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1338039|NCT01968135|Secondary|Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred||over the 14 day course of study drug||||days||Full Range|Median
1321204|NCT02275052|Secondary|Change From Baseline in Functional Residual Capacity (FRC) 3 Hours Post-dose at Week 12 of Each Treatment Period|FRC is defined as the amount of air still left in the lungs after breathing out normally. Standard body plethysmography techniques were used for lung volumes. Baseline is the assessment recorded before dosing on Day 1 of each period. Mean Baseline is the mean of the Baselines for each participant. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. FRC 3 hours post-dose was measured from the value obtained 3 hours after dosing on Day 2 and Week 12. Analysis was performed using a repeated measures model and the following covariates were included: period Baseline, mean Baseline, period, treatment, visit, smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1321205|NCT02275052|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|Trough FEV1 is a measure of lung function and is defined as the mean of FEV1 values obtained 23 and 24 hours after dosing on the previous day. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline was the assessment recorded before dosing on Day 1 of each period. Mean Baseline is the mean of the Baselines for each participant. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Analysis was performed using a repeated measures model and the following covariates were included: period Baseline, mean Baseline, period, treatment, visit, smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1321206|NCT02275052|Primary|Change From Baseline in Exercise Endurance Time (EET) Post-dose at Week 12 of Each Treatment Period|EET post-dose at W12 is defined as the EET obtained 3 hours after dosing at W12. EET was measured using the externally paced field walking test called endurance shuttle walk test (ESWT). Change from BL in EET at W12 was analyzed using a repeated measures model with covariates of period walking speed, mean walking speed, period, trt, visit (Day 2, W6 and W12), smoking status, visit by period walking speed, visit by mean walking speed and visit by trt interactions. BL was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each par. is the mean of the levels used for the ESWT in each of the two trt periods. Period walking speed for each par. and trt period is the difference between the level for that par. and period and the mean walking speed for that par. Intent-to-treat (ITT) Population: all randomized par., excluding those who were randomized in error, and par. who discontinued trt (off-trt).|Baseline (BL) and at Week (W) 12 of each treatment (trt) period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Seconds (s)||Standard Error|Least Squares Mean
1321207|NCT02274948|Secondary|Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo|ALT was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||Iu/l||95% Confidence Interval|Mean
1321208|NCT02274948|Secondary|Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo|Triglyceride was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||mmol/l||95% Confidence Interval|Mean
1321209|NCT02274948|Secondary|Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo|"HOMA IR (Homeostatic model -Insulin Resistance) was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.~Homeostatic model (HOMA-IR = fasting blood sugar(mmol/l) × fasting insulin(mmol/l) ÷ 22.5)"|One year||||units on a scale||95% Confidence Interval|Mean
1321210|NCT02274948|Secondary|Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo|Fasting insulin was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||pmol/l||95% Confidence Interval|Mean
1321211|NCT02274948|Primary|Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo|BMI and Percentage Fat Mass SDS was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||Z score||95% Confidence Interval|Mean
1321212|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||Baseline|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Full Range|Mean
1321213|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||2hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
1321214|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||4hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
1321215|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||12hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
1321216|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||24hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
1321223|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 24|Participants with a positive anti-etanercept antibody binding response at week 24|||percentage of participants||95% Confidence Interval|Number
1321224|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12||Week 12|Participants with available antibody response data at week 12|||percentage of participants||95% Confidence Interval|Number
1321225|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24||Week 24|Participants with available antibody response data at week 24|||percentage of participants||95% Confidence Interval|Number
1321226|NCT02274792|Primary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study|Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.|Primary Antibody Analysis Set included all enrolled participants who received ≥ 1 dose of investigational product and had both a baseline and ≥ 1 post-baseline serum obtained for anti-etanercept antibody assessment, excluding participants with a negative antibody response at week 12 and missing antibody assessment at week 24.|||percentage of participants||95% Confidence Interval|Number
1321227|NCT02274766|Secondary|Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)|A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 4, 8, and 12 visits.|Baseline to Week 12|MITT population|||hours||Standard Error|Least Squares Mean
1321228|NCT02274766|Primary|Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score|The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.|Baseline to Week 12|MITT population|||units on a scale||Standard Error|Least Squares Mean
1321229|NCT02274688|Secondary|Drug Use Problems|The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1321230|NCT02274688|Secondary|Number of Participants With One or More Emergency Department Visits Over Time|The investigators used population level data on emergency department health service use for the intent-to-treat sample|The investigators assessed emergency department service use over the course of the study.||||Participants|||Count of Participants
1321231|NCT02274688|Secondary|Number of Patients Carrying a Weapon|The investigation used a single yes/no item to assess whether the patient was carrying a weapon.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||Participants|||Count of Participants
1321232|NCT02274688|Secondary|Number of Participants With Suicidal Ideation|The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of > 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||Participants|||Count of Participants
1321233|NCT02274688|Secondary|Functional Status|The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. No other subscales will be used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1321234|NCT02274688|Secondary|Alcohol Use Problems|The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1321235|NCT02274688|Primary|Change in Depression Symptoms Over the Course of the Six Months After Injury|The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1321236|NCT02274688|Primary|Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury|The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1321237|NCT02274688|Primary|Change in Post Traumatic Concerns Over the Course of the Six Months After Injury|The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||Participants|||Count of Participants
1321238|NCT02274675|Secondary|Wrist's Active Range of Motion|"Introduction: Wrist's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in by moving with their own effort.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized AROM for normal wrist flexion-extension is about 144 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The wrist's AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the subject will move their wrist to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
1321268|NCT02273908|Secondary|Patient Global Improvement of Change (PGIC)|The PGIC is a subject-rated instrument that measures change in the subject’s overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set|||participants|||Number
1321239|NCT02274675|Secondary|Wrist's Passive Range of Motion|"Introduction: Wrist's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in flexion-extension directed by a person manually.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized PROM for normal wrist flexion-extension is about 164 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The wrist PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the wrist will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and store as report in its software."|Passive range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
1321240|NCT02274675|Secondary|Forearm's Passive Range of Motion|"Introduction: Forearm's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition.The normalized forearm pronation-supination is about 169 angular degree, a person who is able to achieve or over this range is considered normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The forearm PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the forearm will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and stored as report in its software."|Passive range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
1321241|NCT02274675|Secondary|Forearm's Active Range of Movement|"Introduction: Forearm's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The normalized AROM for normal forearm pronation-supination is about 157 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree will be 0.~Procedure: The forearm AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60’ and elbow flexed at 90-120’ supported by an adjustable arm rest with strap and the subject will move their forearm to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
1321242|NCT02274675|Secondary|Spasticity Level of Wrist|"Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale.~Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed.~Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch."|Spasticity level of wrist at week 6|Stroke subjects in rehabilitation centre.|||Scores||Standard Deviation|Mean
1321243|NCT02274675|Secondary|Motor Function Assessment of Hand Movement|"Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement.~Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.~Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor function of hand function at week 6|Stroke subjects in rehabilitation centre.|||Scores||Standard Deviation|Mean
1321244|NCT02274675|Primary|Motor Impairment of Wrist and Forearm|"Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.~Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.~Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor impairment of wrist and forearm at week 6|Stroke subjects in rehabilitation centre.|||Scores||Standard Deviation|Mean
1321245|NCT02274558|Secondary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6|Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)|Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).|||Participants|||Count of Participants
1321246|NCT02274558|Secondary|Clinical Global Impression of Change - TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).|||scores on a scale||Standard Error|Least Squares Mean
1323743|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|4 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1321247|NCT02274558|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline and Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).|||scores on a scale||Standard Error|Least Squares Mean
1321248|NCT02273973|Secondary|Percentage of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to 22 weeks|The safety population includes all randomized participants who received at least one dose of taselisib or placebo.|||percentage of participants|||Number
1321249|NCT02273973|Secondary|Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS.|Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||score on a scale||Standard Deviation|Mean
1321250|NCT02273973|Secondary|Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant’s assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS.|Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||score on a scale||Standard Deviation|Mean
1321251|NCT02273973|Secondary|Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI||From Baseline to Surgery (Weeks 17-18)|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percent change||95% Confidence Interval|Number
1321252|NCT02273973|Secondary|Preoperative Endocrine Prognostic Index (PEPI ) Score|To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).|Week 16|Data were not collected for this outcome measure.||||||
1321253|NCT02273973|Secondary|Central Assessments of Changes in Ki67 Levels|Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.|From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18)|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage||95% Confidence Interval|Number
1321254|NCT02273973|Secondary|Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321255|NCT02273973|Secondary|Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321256|NCT02273973|Secondary|Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321269|NCT02273908|Secondary|Clinical Global Impression of Change (CGIC)|The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set|||participants|||Number
1321257|NCT02273973|Secondary|Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321258|NCT02273973|Secondary|Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321259|NCT02273973|Secondary|Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321260|NCT02273973|Secondary|Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants|Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321261|NCT02273973|Secondary|Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321262|NCT02273973|Primary|Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants|Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321263|NCT02273973|Primary|Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321264|NCT02273973|Primary|Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System|Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321265|NCT02273973|Primary|Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1|Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
1321266|NCT02273908|Other Pre-specified|Number of Patients With Adverse Events||Visit2(week4),Final Visit(Week8 or discontinuation)|Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.|||participants of related AEs|||Number
1321267|NCT02273908|Secondary|Work Productivity and Activity Impairment Scale (WPAI:LBP)|"The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline.~In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities."|Final Visit (Week8 or discontinuation)|Full Analysis Set|||percentage of time missed||Standard Deviation|Mean
1324760|NCT02196714|Secondary|Change in QRS Duration From Pre-dose to 12 Hours Post Dose|Change in QRS duration from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
1321270|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -|"The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together.~The Visual Analogue Scale (VAS) is designed to rate the subject’s current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
1321271|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-|The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject’s level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, “confined to bed”). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
1321272|NCT02273908|Secondary|Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)|The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||scores on a scale||Standard Error|Least Squares Mean
1321273|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||scores on a scale||Standard Error|Least Squares Mean
1321274|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||scores on a scale||Standard Error|Least Squares Mean
1321275|NCT02273908|Primary|Change From Baseline in Pain Related Sleep Interference Scale (PRSIS – Past Week Recall)|The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.|Baseline, Final Visit (Week 8)|Full Analysis Set; consisted of subjects who had at least one evaluable observation from any of the patient-reported outcomes, and only evaluable subjects who contributed to the particular outcome were evaluated in each analysis. 'n' signifies number of participants who were evaluable for specified categories at different time points|||scores on a scale||Standard Error|Least Squares Mean
1321276|NCT02273752|Secondary|Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Response rate will be measured at different time points, e.g. 8, 16, and 24 weeks, and will be summarized as percentage of stable disease, complete remission or partial remission along with 95% confidence interval.|Up to 24 weeks|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321277|NCT02273752|Secondary|Type of Treatments for Stomatitis|Type of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321278|NCT02273752|Secondary|Frequency of Treatments for Stomatitis|Frequency of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321279|NCT02273752|Secondary|Dose Interruptions and Adjustments|Dose interruptions and adjustments will be made on a per subject basis and total for the population.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321280|NCT02273752|Secondary|Percentage of Days on Therapy|Percentage of days on therapy will be calculated using the formula: (expected - actual days)/expected x 100.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321281|NCT02273752|Secondary|Downstream Markers of Mammalian Target of Rapamycin (mTOR) Function Measured in Peripheral Blood Mononuclear Cells|Pharmacodynamics will be evaluated for phosphorylated and non-phosphorylated ribosomal protein S6 kinase, protein kinase B, and eukaryotic translation initiation factor 4E-binding protein 1.|Up to day 15 of course 1|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321282|NCT02273752|Secondary|Progression Free Survival (PFS)|PFS will be evaluated based on rates of cancer progression and time to progression in the population. Progression will be determined using standard RECIST criteria. The median PFS for this study will be estimated by Kaplan-Meier method along with 95% confidence interval.|6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321283|NCT02273752|Primary|Incidence of Stomatitis|Stomatitis graded rates and severity will be evaluated and recorded per World Health Organization and Common Terminology Criteria for Adverse Events criteria in the study population.|Day 29|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
1321287|NCT02273323|Secondary|Systolic Blood Pressure Supine|Systolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
1321288|NCT02273323|Secondary|Endothelium-independent Vasodilation|Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter|2.5 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||percentage of change in diameter||95% Confidence Interval|Least Squares Mean
1321289|NCT02273323|Primary|Flow Mediated Dilation|"Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:~1 minute baseline scan to measure the baseline diameter of artery~5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter"|Before and 2 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||percentage of change in diameter||Standard Deviation|Least Squares Mean
1321290|NCT02273310|Secondary|Acceptability of Intervention|Families in the FTC group rated acceptability of participating in the intervention workshop. This measure was completed at the workshop (between baseline and 6 month assessments). This measure utilized a 5-point Likert-type scale (with the possible range of scores as 1-5), with higher scores indicating more positive feedback. Individual item scores are presented here. Participant results indicated a range of scores from from 2-5.|post intervention||||units on a scale||Standard Deviation|Mean
1321291|NCT02273310|Secondary|Number of Accommodations Provided to Families by Schools|Number of Accommodations Provided to Families by Schools As reported by caregivers|6 months||||Number of Accommodations||Standard Deviation|Mean
1321292|NCT02273310|Secondary|School Functioning-Absences|School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences.|6 months||||Weeks (1 week = 7 days)||Standard Deviation|Mean
1321293|NCT02273310|Primary|Child-Reported Health Related Quality of Life-School Functioning Subscale|Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.|6 months||||units on a scale||Standard Deviation|Mean
1321294|NCT02273180|Other Pre-specified|Change in Daily Insulin Dose From Baseline to Week 26 and Week 52|Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively.|Baseline, Week 26, Week 52|Analysis was performed on safety population. Here, number analyzed in each row = participants with available data for specified categories.|||U/kg||Standard Deviation|Mean
1321295|NCT02273180|Secondary|Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)|Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Analysis was performed on anti-insulin antibody population that included all participants randomized and exposed to at least 1 dose of IMP (SAR342434 or Humalog) with at least one AIA sample available for analysis during the 12-month on-treatment period.|||percentage of participants|||Number
1321296|NCT02273180|Secondary|Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions|Percentage of participants with hypersensitivity reactions and injection site reactions were reported.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Analysis was performed on safety population.|||percentage of participants|||Number
1321297|NCT02273180|Secondary|Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year|Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Analysis was performed on safety population that included all participants randomized and exposed to at least 1 dose of investigational medicinal product (IMP) (SAR342434 or Humalog), regardless of the amount of treatment administered.|||events per participant-year|||Number
1321298|NCT02273180|Secondary|Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26|Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number analyzed in each row = participants with at least one post-baseline data during the main 6-month period for specified categories.|||mmol/L||Standard Error|Least Squares Mean
1321388|NCT02271477|Secondary|Percentage of Participants Administered Vasoactive Drug|"Total amount of vasoactive drug administered for each group; for vasoactive drug we intended the use both of atropine than vascular amine"|30 minutes after spinal anesthesia||||percentage of participants|||Number
1321389|NCT02271477|Secondary|Total Amount of IV Fluid at the End of the Procedure|To assess if there is a difference between all treatments in the total quantity of fluids amount|30 minutes after spinal anesthesia||||milliliters (mL)||Inter-Quartile Range|Median
1321299|NCT02273180|Secondary|Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26|Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline mean 24-hour plasma glucose concentration assessment during the main 6-month period.|||mmol/L||Standard Error|Least Squares Mean
1321300|NCT02273180|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline FPG assessment during the main 6-month period.|||mmol/L||Standard Error|Least Squares Mean
1321301|NCT02273180|Secondary|Percentage of Participants With HbA1c <7.0% at Week 26|Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.|Week 26|Analysis was performed on ITT population.|||percentage of participants|||Number
1321302|NCT02273180|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, irrespective of compliance with the study protocol and procedures. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during the main 6-month period.|||percentage of HbA1c||Standard Error|Least Squares Mean
1321303|NCT02273167|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. PDR defined as the number of patients with at least one polyp in the overall colon.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analysed is based on the mFAS. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).|||Participants|||Number
1321304|NCT02273167|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug|||Participants|||Count of Participants
1321305|NCT02273167|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321306|NCT02273167|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321307|NCT02273167|Primary|Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321324|NCT02273050|Secondary|Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24 weeks of double-blinded treatment.|Baseline to Week 24|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||Percentage of patients|||Number
1321308|NCT02273167|Primary|Number of Patients With Successful Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321309|NCT02273141|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the overall colon.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321310|NCT02273141|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321311|NCT02273141|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).|||Participants|||Count of Participants
1321312|NCT02273141|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|One day (day before colonoscopy).|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321313|NCT02273141|Primary|Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus SP+MS was evaluated using a non-inferiority study design.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321314|NCT02273141|Primary|Number of Patients With Successful Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus SP+MS was evaluated using a non-inferiority study design.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321315|NCT02273115|Secondary|Neonatal Outcome: Neonatal Weight||Assessed from birth through discharge, on average 2 days after birth||||grams||Standard Deviation|Mean
1321316|NCT02273115|Secondary|Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7||Assessed from birth through discharge, on average 2 days after birth||||Participants|||Count of Participants
1321317|NCT02273115|Secondary|Obstetric Complications||Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period||||Participants|||Count of Participants
1321318|NCT02273115|Secondary|Regional Analgesia|Regional analgesia used during Foley ripening|Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours||||Participants|||Count of Participants
1321319|NCT02273115|Secondary|Number of Vaginal Deliveries||Assessed after delivery, on average occurring between 24-48 hours||||Participants|||Count of Participants
1321320|NCT02273115|Secondary|Time to Foley Expulsion||0-12 hours||||hours||Inter-Quartile Range|Median
1321321|NCT02273115|Secondary|Total Time to Delivery||On average, 24-36 hours||||hours||Inter-Quartile Range|Median
1321322|NCT02273115|Secondary|Number of Participants With Time to Delivery Achieved Within 12 Hours|Number of participants with a time from Foley placement to delivery less than or equal to 12 hours|Within 12 hours||||Participants|||Count of Participants
1321323|NCT02273115|Primary|Delivery Rate|The rate of women who deliver in less than or equal to 24 hours from Foley placement.|Within 24 hours||||Participants|||Count of Participants
1321325|NCT02273050|Secondary|Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 120-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 prior to rescue|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration, and participated in a meal tolerance test.|||mmol/L||Standard Error|Least Squares Mean
1321326|NCT02273050|Secondary|Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c ≤ 6.5% at the end of 24 weeks of double-blinded treatment.|Week 24 (prior to rescue)|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||Percentage of patients|||Number
1321327|NCT02273050|Secondary|Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 180-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 prior to rescue|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration, and participated in a meal tolerance test.|||mmol*min/L||Standard Error|Least Squares Mean
1321328|NCT02273050|Secondary|Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in fasting plasma glucose at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 prior to rescue|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||mmol/L||Standard Error|Least Squares Mean
1321329|NCT02273050|Secondary|Glycemic Response Defined as HbA1c < 7.0% at Week 24|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c < 7.0% at the end of 24 weeks of double-blinded treatment.|Week 24 (prior to rescue)|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||Percentage of patients|||Number
1321330|NCT02273050|Primary|Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 (prior to rescue)|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||% HbA1c||Standard Error|Least Squares Mean
1321331|NCT02273037|Secondary|Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery)|"Compare the proportion of cesarean delivery between the Pinard and Doppler group.~(Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted delivery)"|Birth||||Participants|||Count of Participants
1321332|NCT02273037|Secondary|Identification of Abnormal Fetal Heart Rate|Compare the incidence of identification of abnormal fetal heart rate in labour in the Pinard and Doppler group.|In labour||||Participants|||Count of Participants
1321333|NCT02273037|Primary|Quality of Partograms|To assess the quality of partographs using a standardized scoring system to audit overall completion and quality, and fetal heart rate monitoring specifically. The investigators will compare the audit results between partographs in the Pinard and Doppler group.|in labour|||||||
1321334|NCT02273037|Primary|Stillbirth and Neonatal Death|Compare the incidence of fresh stillbirth and neonatal death (within 24h of age) in the Pinard group (current practice) and the Doppler group (study intervention).|0-24hour of delivery||||Participants|||Count of Participants
1321335|NCT02272803|Secondary|PFS Rate at 1 Year|The number of participants with PFS at 1 year post-randomization was divided by the total number randomized in that arm and expressed as a percentage. PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.|1 year|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
1321336|NCT02272803|Secondary|Progression Free Survival (PFS) in Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone Therapy|PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.|From randomization to the date of first documented tumor progression or death due to any cause (assessed up to February 2017, approximately 24 months)|All randomized participants|||months||95% Confidence Interval|Median
1321354|NCT02271984|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ)||Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||hour||Full Range|Median
1324761|NCT02196714|Secondary|Change in QRS Axis From Pre-dose to 12 Hours Post Dose|Change in QRS axis from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||QRS axis||Full Range|Mean
1321337|NCT02272803|Secondary|Objective Response Rate (ORR) in All Treated Participants|"ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until documented response (assessed up to February 2017, approximately 24 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1321338|NCT02272803|Primary|Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)|"ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until documented response (assessed up to February 2017, approximately 24 months)|Participants treated with E-Ld|||Percentage of participants||70% Confidence Interval|Number
1321339|NCT02272725|Secondary|Exercise-Associated Hyponatremia|The count of participants experiencing exercise-associated hyponatremia (defined as < 135 mEq) will be estimated from measured point-of-care blood test at the finish line immediately following completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours||||Participants|||Count of Participants
1321340|NCT02272725|Secondary|Perceived Exertion|A Borg score of perceived exertion will be measured at the finish line immediately following completion of a 50 mile ultramarathon to measure what affect ibuprofen had on perceived exertion as analgesia may have made the endurance event perceived as less exertional. Scores range from 7 - 20, with higher scores indicative of greater amount of exertion.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours||||units on a scale||Standard Deviation|Mean
1321341|NCT02272725|Primary|Acute Kidney Injury|The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours||||Participants|||Count of Participants
1321342|NCT02271984|Secondary|Number of Subjects With Clinical Significant Laboratory Abnormalities, Electrocardiogram (ECG), Physical Examination and Vital Signs Reported as Treatment Emergent Adverse Events|Any clinically significant changes in laboratory evaluations ECGs,physical examination (body weight) and vital signs (temperature, blood pressure, pulse rate) were recorded as treatment emergent adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, hematocrit, red blood cell count, mean cell hemoglobin [MCH], MCH concentration, mean cell volume, white cell count, platelets, neutrophils, lymphocytes, monocytes, eosinophils, Basophils); serum chemistry (sodium, potassium, calcium, inorganic phosphate, creatinine, total protein, albumin, urea, uric acid, aspartate aminotransferase [AST], alanine aminotransferase [ALT] gamma glutamyl transpeptidase, total bilirubin, alkaline phosphatase, glucose, triglycerides cholesterol); urinalysis (protein, glucose, ketones, pH, blood, leukocytes, nitrite); The 12-lead ECGs were recorded after the subjects had rested for at least 5 minutes in supine position.|From the first dose of study drug administration up to 3-10 days after the last dose of the study drug (up to a maximum of 7 weeks)|The safety analysis set consisted of all subjects who received at least one dose of the trial medication and who had follow-up safety assessments.|||Subjects|||Number
1321343|NCT02271984|Secondary|Palatability Score|"Each administration was assessed at 0 minutes on Day 1 for flavor, smell, sweetness, overall liking of the medicine and at 2-5 minutes on Day 1 for taste in mouth and acceptability to swallow using a modified 100 millimeter (mm), visual analog scale (VAS) incorporating a facial hedonic scale, where lower score (0) indicates not acceptable/not liked at all and higher score (100) indicates very acceptable/liked very much."|0 min for flavor, smell, sweetness, overall liking; 2-5 minutes post dose for taste in mouth and acceptability on Day 1|The safety analysis set consisted of all subjects who received at least one dose of the trial medication and who had follow-up safety assessments.|||millimeter (mm)||Standard Deviation|Mean
1321344|NCT02271984|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were adverse events that occurred between the first dose of study drug and up to 3-10 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Subjects who discontinued and who died due to TEAEs were also reported.|From the first dose of study drug administration up to 3-10 days after the last dose of the study drug (up to a maximum of 7 weeks)|The safety analysis set consisted of all subjects who received at least one dose of the trial medication and who had follow-up safety assessments.|||Subjects|||Number
1321384|NCT02271698|Primary|Change in Opioid Consumption|mg of morphine equivalents|6, 12, 18, 24, 36 hours after surgery|Participants who completed pain score at specified time-points.|||mg of morphine equivalents||Standard Deviation|Mean
1321345|NCT02271984|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-Praziquantel (L-PZQ)|The Vz/f was defined as the theoretical volume in which the total amount of L-PZQ required to uniformly distribute to produce the desired plasma concentration of L-PZQ. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant (lambda z) (Vz/f=Dose/( AUC0-inf* lambda z).|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1321346|NCT02271984|Secondary|Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-Praziquantel (L-PZQ)|The CL/f of L-PZQ was a measure of the rate at which it was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. The CL/F of L-PZQ from plasma was calculated using the formula: Dose divided by area under the concentration time curve from time zero to infinity (AUC0-inf).|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
1321347|NCT02271984|Secondary|Apparent Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ)|The lambda z was calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||per hour (1/hour)||Geometric Coefficient of Variation|Geometric Mean
1321348|NCT02271984|Secondary|Relative Bioavailability (Frel) of L-Praziquantel (L-PZQ)|Relative bioavailability (Frel) was calculated for L-PZQ only (treatment A versus treatment B) using the formula: Frel = (AUC0-inf (test or Treatment A)/AUC0-inf (reference or treatment B)) multiplied by 100.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The PK population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||Percentage bioavailability||95% Confidence Interval|Geometric Mean
1321349|NCT02271984|Secondary|Apparent Terminal Half-life (T1/2) of L-Praziquantel (L-PZQ)|The apparent terminal half-life was calculated by dividing natural log 2 with lambda z (ln2/lambda Z); where lambda Z is the terminal rate constant.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||hour||Full Range|Median
1321350|NCT02271984|Secondary|Maximum Observed Concentration in Plasma (Cmax) of L-Praziquantel (L-PZQ) After Dose Adjustment||Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The PK population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1321351|NCT02271984|Secondary|Extrapolated Area Under the Concentration Time Curve (AUC) From Time Tlast to Infinity Given as Percentage From AUC0-inf (AUCextra) of L-Praziquantel (L-PZQ)|Extrapolated AUC from time tlast to infinity given as percentage from AUC0-inf. AUCextra =(last predicted concentration [Clast pred] divided by terminal elimination rate constant [lambda z]) divided by AUC0-inf., where Clast pred is the last predicted concentration.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||Percent extrapolated||Geometric Coefficient of Variation|Geometric Mean
1321352|NCT02271984|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of L-Praziquantel (L-PZQ) After Dose Adjustment|The AUC (0-t) was defined as the area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration at or above the lower limit of quantification (AUC0-t) of L-PZQ.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1321353|NCT02271984|Secondary|Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ)|Time prior to the first measurable (non-zero) concentration (tlag) of drug L-PZQ|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||hour||Full Range|Median
1321355|NCT02271984|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1321356|NCT02271945|Secondary|Time to Response (TTR)|Time to response (TTR) defined as the time from the start of study drug administration until the first documentation of disease response. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
1321357|NCT02271945|Secondary|Overall Survival (OS)|Overall survival defined as the time from the start of study drug administration until death due to any cause.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
1321358|NCT02271945|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the start of study drug administration until the first documentation of disease progression or death due to any cause, whichever occurs first.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
1321359|NCT02271945|Secondary|Duration of Disease Control|Duration of disease control is defined as the time period from the start of disease control event to the event of disease progression.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
1321360|NCT02271945|Secondary|Number of Participants With Disease Control|Disease control includes CR (disappearance of all evidence of disease), PR (regression of measurable disease and no new sites), or SD for at least 8 weeks.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
1321361|NCT02271945|Secondary|Duration of Complete Response|Duration of Complete Response defined as time from start of first documented Complete Response [CR] to the time of disease progression or death, whichever occurs first. Only participants who have achieved complete response assessed by investigator were evaluated.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
1321362|NCT02271945|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680|A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study.|30 min prior to infusion of MEDI-551 on Day 1 of Cycles 1, 2, 6, 9, and 12 and up to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Number
1321363|NCT02271945|Secondary|Terminal Half-Life (t1/2) of MEDI0680|Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.|EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||h||Full Range|Median
1321364|NCT02271945|Secondary|Terminal Half-Life (t1/2) of MEDI551|Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.|EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||h||Full Range|Mean
1321365|NCT02271945|Secondary|Mean Peak and Trough Concentrations of MEDI0680|The mean peak and Trough concentration of MEDI0680 were observed. Peak is the end of infusion measurement and the Trough is the pre-dose measurement.|EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||mcg/mL||Standard Deviation|Mean
1321366|NCT02271945|Secondary|Mean Peak and Trough Concentrations of MEDI551|The mean peak and Trough concentration of MEDI551 were observed. Peak is the end of infusion measurement and the Trough is the pre-dose measurement.|End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||mcg/mL||Standard Deviation|Mean
1321367|NCT02271945|Primary|Number of Participants With Best Overall Response|The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: complete response (disappearance of all evidence of disease), partial response (regression of measurable disease and no new sites), stable disease (SD), progessive disease (PD), and non- evaluable (NE).|Day 1 to Day 28 of Cycle 13 (28-day cycle)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
1321385|NCT02271698|Primary|Change in Visual Analogue Pain Score|Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where “0” represents no pain and “10” represents worst pain ever.|6, 12, 18, 24, 36 hours after surgery|Participants who completed pain score at specified time-points.|||units on a scale||Standard Deviation|Mean
1321386|NCT02271529|Primary|Mean Percent Change in Stent Length Upon Deployment||Immediately following completion of the stent placement procedure|There were 63 implanted stents, an assessment of stent length change was not available for 2 stents.|||percentage of change in stent length|Participants|Standard Deviation|Mean
1321368|NCT02271945|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities|Vital signs included parameters such as blood pressure, temperature, respiratory rate, and pulse oximetry. An abnormal vital signs and physical findings that was judged by the investigator to be medically significant was reported an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the end of study treatment.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
1321369|NCT02271945|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities|An abnormal laboratory findings that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the end of study drug.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
1321370|NCT02271945|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. SAE is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
1321371|NCT02271945|Primary|Maximum Tolerated Dose (MTD) of MEDI-551|The Maximum Tolerated Dose, defined as the highest dose where less than or equal to (<= 1) out of 6 subjects experiences a dose limiting toxicity (DLT) during the DLT evaluation period (Day 1 to Day 28 of Cycle 1) or the highest protocol specified dose not exceeding MTD.|Day 1 to Day 28 of Cycle 1 (28-day cycle)|Evaluable Population for DLT included all participants in the dose escalation portion who received all protocol assigned doses and completed safety follow-up during the first 28-day period of therapy, or experienced a DLT during the DLT evaluation period.|||mg/kg|||Number
1321372|NCT02271880|Secondary|Followup Medication Adherence|Continued monitoring of prescribed doses taken over 12-month followup period|30 months|||||||
1321373|NCT02271880|Secondary|Maintenance of Medication Adherence|Continued monitoring of prescribed doses taken over 12-month monitoring period|18 months|||||||
1321374|NCT02271880|Secondary|Impairment Rating Scale|Parent and adolescent ratings of functional impairment|Posttreatment (6 months)|||||||
1321375|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale|Parent and adolescent ratings of Attention Deficit Hyperactivity Disorder (ADHD) and comorbid symptoms|Posttreatment (6 months)|||||||
1321376|NCT02271880|Primary|Medication Adherence|Percentage of prescribed doses taken as measured by electronic monitoring devices.|Posttreatment (6 months)|||||||
1321377|NCT02271854|Secondary|Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.|"Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome.~Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i."|48 hours||||units on a scale (NRS)||Standard Deviation|Mean
1321378|NCT02271854|Primary|Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.|The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) – 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) – T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.|24 hours||||units on a scale (NRS)||Standard Deviation|Mean
1321379|NCT02271698|Other Pre-specified|Change in Interleukin 6 and 10 Levels|Interleukin levels and the ratio will assess pro and anti inflammatory processes in the patients|Sample immediately prior to incision and at 10-14, 22-26 and 33-39hours after surgery.|||||||
1321380|NCT02271698|Other Pre-specified|Change in Macrophage Proliferation|Macrophage totals and differentiation will be assessed within patients and between groups.|Samples will be taken immediately pre incision and will be repeated at 33-39hours|||||||
1321381|NCT02271698|Secondary|Change in Functional Status as Measured by Brief Pain Inventory Questionnaire|Brief pain inventory questionnaire will be administered generating a score (0-70). Higher scores reflect higher perceived pain interference.|Baseline at Enrollment, 3 and 6 months after surgery|Participants who completed questionnaire|||units on a scale||Inter-Quartile Range|Median
1321382|NCT02271698|Secondary|Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire|Brief pain inventory questionnaire will be administered generating a score (0-40). Higher scores reflect higher perceived pain.|Baseline at enrollment, 3 months and 6 months after surgery|Participants who completed questionnaire|||units on a scale||Inter-Quartile Range|Median
1321383|NCT02271698|Secondary|Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index|The Western Ontario and McMaster Universities Osteoarthritis Index measures 17 items for functional limitation (score range 0–68). Higher score = higher difficulty with the task.|30 days, 3 and 6 months following surgery|Participants who completed questionnaire|||units on a scale||Inter-Quartile Range|Median
1321390|NCT02271477|Primary|Rate of Arterial Hypotension|To compare rates of arterial hypotension (previously define by international standard) after spinal anesthesia in patients who have undergone volemic optimization according to Trans-thoracic Echocardiography with patients who have been treated according to the current standard on the intention to treat population.|30 minute after spinal anesthesia|Rate of arterial hypotension after standardized spinal anesthesia|||percentage of participants|||Number
1321391|NCT02271217|Secondary|Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)|"The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility.~Walk-12 Score = 100 * [(Mean of the 12 items) – 1]/(5-1)"|Baseline, week 12|Includes all randomized subjects who took at least one dose of double-blind study treatment, had at least one 2MinWT assessment during the placebo run-in period, and at least one 2MinWT assessment during the double-blind treatment period.|||units on a scale||Standard Deviation|Mean
1321392|NCT02271217|Primary|Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12|"The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered Responders."|Week 12|Includes all randomized subjects who took at least one dose of double-blind study treatment, had at least one 2MinWT assessment during the placebo run-in period, and at least one 2MinWT assessment during the double-blind treatment period.|||participants|||Number
1321393|NCT02270944|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Safety was assessed as the number of subjects who reported SAEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From Day 1 to Day 181 (end of the study)|Analyses were evaluated on the Unsolicited AEs Safety Set (i.e. all subjects in the exposed set who provided information about post vaccination unsolicited AEs). There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.|||Subjects|||Number
1321394|NCT02270944|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Safety was assessed as the number of subjects who reported unsolicited AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From Day 1 to Day 181 (end of the study)|Analyses were evaluated on the Unsolicited AEs Safety Set (i.e. all subjects in the exposed set who provided information about post vaccination unsolicited AEs). There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.|||Subjects|||Number
1321395|NCT02270944|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Safety was assessed as the number of subjects who reported solicited local and solicited systemic AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From 6 hours through Day 7 post-vaccination|Analyses were evaluated on the Solicited Safety Set (i.e. all subjects in the exposed set with data on post vaccination local or systemic AEs or other signs of reactogenicity). For 3 treated subjects in the Liquid GBS trivalent vaccine group, no safety data were available and for 4 subjects from both groups, no solicited safety data were reported.|||Participants|||Count of Participants
1321396|NCT02270944|Primary|Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Ib data are not yet available due to testing to be completed with new assay currently in development.|At Day 31 after a single vaccination||2019-12-31|12/2019||||
1321397|NCT02270944|Primary|Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 after a single vaccination|All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding & provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.|||µg/mL||95% Confidence Interval|Geometric Mean
1321398|NCT02270944|Primary|Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 after a single vaccination|All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding & provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.|||µg/mL||95% Confidence Interval|Geometric Mean
1321399|NCT02270684|Primary|Knee Osteoarthritis Outcome Score (KOOS)|The KOOS is a validated tool to measure pain and quality of life in patients after TKA|Baseline, 4, 10, 24 weeks|Due to early termination, no evaluable data was collected||||||
1321400|NCT02270515|Primary|Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models|Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|Baseline (0) to 18 months|All records with data for the KDQOL scale score (dependent variable) and covariates were included in the analysis. Two participants were excluded due to missing data for covariates: dialysis vintage and PCP at baseline. The previous table (adjusted means) shows the number of records with complete data for each visit.|||units on a scale||Standard Error|Mean
1321401|NCT02270515|Primary|Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted|"Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.~Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|Baseline (0) to 18 months|Ns shown in the table are the number of records at each visit with data for the KDQOL scale score and all covariates. All available records were used to estimate the adjusted means. For all scales, N=173 participants; 2 were excluded due to missing data for covariates: dialysis vintage and PCP at baseline.|||units on a scale||Standard Error|Mean
1321402|NCT02270515|Primary|Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted|Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|Baseline (0) to 18 months|Overall number of participants analyzed are the number who completed the KDQOL at each visit. They differ slightly from the number of participants in the flow chart due to missing KDQOL data. Ns are slightly lower for some scale scores due to missing items (see below).|||units on a scale||Standard Deviation|Mean
1321403|NCT02269943|Secondary|Apparent Volume of Distribution (Vz/F) Of CC-486|Apparent volume of distribution, calculated as [(CL/F)/λz].|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1321404|NCT02269943|Secondary|Apparent Total Clearance (CL/F) Of CC-486|Apparent volume of distribution, calculated as [(CL/F)/λz].|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
1321405|NCT02269943|Secondary|Terminal Half-Life (t1/2) of CC-486|Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 was only calculated when a reliable estimate for λz could be obtained.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1321406|NCT02269943|Secondary|Time to Reach Maximum Concentration (Tmax) Of CC-486|Time to Cmax, obtained directly from the observed concentration versus time data.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Hours||Full Range|Median
1321407|NCT02269943|Secondary|Maximum Observed Concentration (Cmax) Of CC-486|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1321408|NCT02269943|Secondary|Area Under the Plasma Concentration -Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0-∞) Of CC-486|Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1321409|NCT02269943|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t)|Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1321410|NCT02269943|Secondary|Number of Participants With Treatment Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|From date of first dose of study treatment to 28 days after last dose of study treatment; up to final data cut-off date of 08 August 2017; median treatment duration was 257 days for CC-486 200 mg and 114.5 days for CC-486 300 mg|The Safety Population included all participants who received at least 1 dose of IP.|||Participants|||Count of Participants
1321411|NCT02269943|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks From the Date of the First Treatment, or CR or PR According to RECIST 1.1 Criteria and Based on an Independent Radiology Assessment|Disease Control Rate (DCR) was defined as the percentage of participants with a CR, PR, confirmed ≥ 4 weeks after the criteria for response were first met, or stable disease for ≥ 16 weeks from the first treatment, based on independent radiology assessment using RECIST 1.1 criteria. A complete response was defined as the disappearance of all target lesions and non-target lesions; a partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease|Tumor response was assessed every 6 weeks for the first 3 evaluations then every 9 weeks until disease progression. As of the cut-off date of 08 August 2017 the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose|Efficacy Evaluable Population = enrolled participants who met eligibility criteria and either received 2 cycles of IP at any dose and discontinued treatment for progressive disease or received 4 cycles of IP and had at least 2 post-screening tumor exams.|||percentage of participants||90% Confidence Interval|Median
1321412|NCT02269943|Secondary|Kaplan Meier Estimate of Overall Survival|Overall survival was the time from the first dose of study drug to patient death from any cause. Participants who did not die were censored at the last known time the patient was alive date or the clinical data cutoff date, whichever was earlier.|From Day 1 of study treatment to the first date of progressive disease or death; up to data cut-off date of 08 August 2017; overall median follow-up time for censored participants was 20.4 months|The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments.|||months||90% Confidence Interval|Median
1321413|NCT02269943|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on an Independent Radiology Assessment According to RECIST 1.1 Criteria|PFS was defined as the time from the date of start of the study treatment to the date of disease progression or death (any cause) on or prior to the data cut-off date for the statistical analysis, whichever occurred earlier, based on an independent radiology assessment of response using RECIST v1.1 criteria. Progressive disease was defined as at least a 20% increase in the sum of diameters of target or non-target lesions from nadir or appearance of a new lesion.|From Day 1 of documented disease progression; up to data cut off date of 08 August 2017; median follow-up time for censored participants was 12.3 months|The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments.|||months||90% Confidence Interval|Median
1321414|NCT02269943|Primary|Percentage of Participants Who Achieved a Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Based on an Independent Radiology Assessment (IRA)|"Overall response rate was defined as the combined incidence of Complete Response (CR) or Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met, based on independent radiology assessment according to RECIST 1.1 criteria.~Complete response was defined as the disappearance of all target lesions and non-target lesions; Partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline."|Tumor response was assessed every (Q) 6 weeks for the first 3 evaluations then Q 9 weeks until disease progression as of the cut-off date of 08 August 2017; the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose|The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments.|||percentage of participants||90% Confidence Interval|Number
1321415|NCT02269709|Secondary|IVC Pressure|Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care.|Baseline and Follow Up Number 1 (approximately 24 -72 hours later)|Subjects who had undergone the Fontan operation and who had a central line placed. Blood pressure values were obtained from chart review.|||mmHg||Standard Error|Mean
1321416|NCT02269709|Primary|Shear Wave Speed (Liver Stiffness)|ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.|0-6 months|As shown in the participant flow, data was not captured for follow up time points 1 and 2 for 1 participant. At time point 3 data is only available for 5 participants.|||meters per second||Standard Deviation|Mean
1321417|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. Images were only recorded during the wall and clavicle position, not during the natural standing position. Pressure mat parameters were recorded for both arm positions and compared to the natural standing position (arms hanging on either side).|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions and pressure mat recording in the two positions and the natural standing position.|||percentage of pressure under||Standard Deviation|Mean
1321418|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
1321419|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
1321420|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
1321421|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
1321422|NCT02269488|Primary|Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250|"Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number.~Solicited symptoms are events that are considered likely to occur post dosing. For this study, solicited symptoms include Fever ≥ 100.4°F (38.0°C) by any route, Runny/stuffy nose, Sore throat, Cough, Headache, Generalized muscle aches, Decreased activity level (lethargy) or tiredness/weakness, Decreased appetite and Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) will be omitted when, according to the judgment of the investigator, the subject is too young to reliably report a particular symptom"|14 days post vaccination||||subjects|||Number
1321423|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population|||Participants|||Number
1321424|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)|through the end of the influenza surveillance period, up to end Apr (6 months)||||Participants|||Number
1321425|NCT02269475|Primary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population|||Participants|||Number
1321426|NCT02269098|Other Pre-specified|ED Visits and Hospitalizations|number ED visits and hospitalizations pre and post intervention as self-reported by participants|12 weeks|Self reported Number of ED visits and hospitalizations 3 months prior to and 3 months after the intervention|||number of ED visits and hospitlizations|||Number
1321427|NCT02269098|Secondary|Hypoglycemia|Hypoglycemia was defined as BG < 70mg/dL. Severe hypoglycemia was defined as BG <40mg/dL and/or requiring assistance to treat. We tracked the total number of hypoglycemia episodes in each group.|4 weeks|we collected data on the total number of hypoglycemia episodes in each group, not the number or participants with hypoglycemia as some participants had more than 1 episode and we wanted to capture those as separate incidents.|||total incidents of hypoglycemia|||Number
1321428|NCT02269098|Secondary|Blood Glucose < 180mg/dL|Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline|4 weeks||||participants|||Number
1321429|NCT02269098|Primary|Medication Adherence|Score on 8 item Modified Morisky Medication Scale used to assess medication adherence. This scale is a structured and widely used self reported questionnaire used to assess medication taking behaviors.The total score ranges from 0 to 8. A score of 0 is considered “high”adherence, 1 to 2 is considered “medium” adherence, and >2 is considered “low” adherence.|4 weeks|33 patients in the intervention group and 30 in the control group completed the scale at baseline and at 4 weeks and their data was analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1321430|NCT02269098|Primary|Hemoglobin A1C at 4 Weeks|Hemoglobin A1C at index/baseline visit in the ED and at 4 weeks. A1C was measured using the Bayer A1C-Now+ point of care test system device. If the reading was over 13%, the upper limit of the assay, a venous sample A1C was sent to the hospital lab for analysis.|4 weeks|Participants who completed the full 4 week study period were included in the primary outcomes analysis.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1321431|NCT02268994|Secondary|Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline|The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.|Baseline and week 16||||mg/dL||Standard Error|Least Squares Mean
1321432|NCT02268994|Secondary|Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)|Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period|Week 16||||Participants|||Count of Participants
1321433|NCT02268994|Secondary|Mean Change in Ferritin at the End of 16 Weeks Minus Baseline|The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.|Baseline and week 16||||ng/mL||Standard Error|Least Squares Mean
1321434|NCT02268994|Secondary|Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline|The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.|Baseline and week 16||||% saturation||Standard Error|Least Squares Mean
1321435|NCT02268994|Secondary|Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline|The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.|Baseline and week 16||||g/dL||Standard Error|Least Squares Mean
1321436|NCT02268994|Primary|Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period|Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.|Week 16||||Participants|||Count of Participants
1321437|NCT02268877|Primary|Emergency Department Length-of-Stay|The time the patient is placed in room to the time that the patient is discharged/admitted.|48 hours||||minutes||Inter-Quartile Range|Median
1324762|NCT02196714|Secondary|Change in PR Interval From Pre-dose to 12 Hours Post Dose|Change in PR Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
1321438|NCT02268877|Primary|Time to Definitive Diagnosis|The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart|24 hours||||minutes||Inter-Quartile Range|Median
1321439|NCT02268864|Secondary|Number of Participants With Viral Relapse|Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA <LLOQ (undetectable) at EOT and had HCV RNA >=LLOQ during the follow-up period.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||participants|||Number
1321440|NCT02268864|Secondary|Number of Participants With Viral Breakthrough|Participants were considered to have had viral breakthrough if they had a confirmed greater than (>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA >100 IU/mL while previously having achieved HCV RNA <LLOQ when on study treatment.|Up to Week 24|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||participants|||Number
1321441|NCT02268864|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie, <LLOQ detectable or greater than equal to (>=) LLOQ at EOT.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants|||Number
1321442|NCT02268864|Secondary|Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24)|Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 24 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants||95% Confidence Interval|Number
1321443|NCT02268864|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4)|Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 4 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants||95% Confidence Interval|Number
1321444|NCT02268864|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (<LLOQ) (detectable or undetectable).|At 12 weeks after end of treatment|The intent-to-treat (ITT) analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants||95% Confidence Interval|Number
1321445|NCT02268526|Secondary|Half-life (T1/2) for CSJ148 Only at Day 85|T1/2 is the terminal elimination half-life [time]|Day 85|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||day||Standard Deviation|Mean
1321446|NCT02268526|Secondary|Lambda_z for CSJ148 Only at Day 85|Lambda_z is the terminal elimination rate constant [1/day] at Day 85|Day 85|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||1/day||Standard Deviation|Mean
1321447|NCT02268526|Secondary|Accumulation Ratio(Racc) for CSJ148 Only at Day 85|Accumulation ratio(Racc) is Racc: Accumulation ratio, calculated by AUCtau (Day 85) divided by AUCtau (for the 1st dose at Day 1).|Day 1 and Day 85|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||Ratio||Standard Deviation|Mean
1321448|NCT02268526|Secondary|Trough Serum Concentration (Ctrough) for CSJ148 Only|Ctrough is The observed plasma (or serum or blood) concentration at the end of a drug administration dosing interval [ug / mL]|Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||ug/mL||Standard Deviation|Mean
1321449|NCT02268526|Secondary|Maximum Serum Concentration During the Dosing Interval (Cmax) for CSJ148 Only|Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration [ug / mL] for CSJ148 only|Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||ug/mL||Standard Deviation|Mean
1321450|NCT02268526|Secondary|Area Under the Serum Concentration-time Curve During the Dosing Interval (AUCtau) for CSJ148 Only|PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The AUCtau was calculated using a linear trapezoidal method|Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||day*ug/mL||Standard Deviation|Mean
1321451|NCT02268526|Secondary|Proportion of Participants Developing HCMV Disease|Proportion of participants developing HCMV disease|98 days|PD analysis set (Cohort 2) -included 59 patients, 27 patients (31%) were excluded.|||proportion of participants||90% Confidence Interval|Number
1321452|NCT02268526|Secondary|Number of Times That Preemptive HCMV Therapy is Required -Cohort 2|Among those who required preemptive therapy, the number of times preemptive therapy was required. (Cohort 2)|98 days|PD analysis set (Cohort 2) -included 59 patients, 27 patients (31%) were excluded.|||number of times||90% Confidence Interval|Least Squares Mean
1321453|NCT02268526|Secondary|Time to Start of Preemptive HCMV Therapy Cohort 2|The time to start preemptive therapy is defined as the number of days between initial dose of study drug and the earlier of (1) the start of preemptive therapy, and (2) the development of HCMV disease or death due to HCMV disease, or (3) censored at the EoT visit if no therapy required for Cohort 2|98 days|PD analysis set (Cohort 2) -included 59 patients, 27 patients (31%) were excluded.|||days||Standard Deviation|Mean
1321454|NCT02268526|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of participants with adverse events as a measure of safety and tolerability. Patients treated with CSJ148 in Cohorts 1 and 2 were pooled to simplify the safety analyses.|98 days|Safety Analysis Set- Eighty-six patients were enrolled in the study and all were included in the safety analysis set|||Count of Participants|||Number
1324763|NCT02196714|Secondary|Change in Heart Rate From Pre-dose to 12 Hours Post Dose|Change in Heart Rate from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||Beats/Min||Full Range|Mean
1321455|NCT02268526|Primary|Number of Participants Who Require Preemptive HCMV Therapy|Number of participants who require preemptive HCMV therapy. The definition of requiring preemptive anti-HCMV therapy was meeting either one of the following conditions: 1. the plasma HCMV DNA level is >= 1000 copies/mL (with or without HCMV disease) or 2. the plasma HCMV DNA level is < 1000 copies/mL, but HCMV disease was reported|98 days|Full Analysis Set - included all 86 patients enrolled in the study|||Count of Participants|||Number
1321456|NCT02268396|Secondary|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage of correct advances|||Number
1321457|NCT02268396|Secondary|Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)|Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount)|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage|||Number
1321458|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage|||Number
1321459|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage of devices|||Number
1321460|NCT02268396|Secondary|Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage of Devices|||Number
1321461|NCT02268396|Primary|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage|||Number
1321462|NCT02268214|Secondary|Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events|Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Participants|||Count of Participants
1321463|NCT02268214|Secondary|Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24|Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Percentage||Standard Error|Least Squares Mean
1321464|NCT02268214|Secondary|Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24|Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||mg/dL||Standard Error|Least Squares Mean
1321465|NCT02268214|Secondary|Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24|Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||mg/dL||Standard Error|Least Squares Mean
1321466|NCT02268214|Secondary|Adjusted Mean Percent Change in Body Weight From Baseline at Week 24|Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Kg||Standard Error|Least Squares Mean
1321467|NCT02268214|Secondary|Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24|Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||IU||Standard Error|Least Squares Mean
1321468|NCT02268214|Primary|Adjusted Mean Change in HbA1c From Baseline at Week 24|Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Percentage of hemoglobin||Standard Error|Least Squares Mean
1321469|NCT02268058|Other Pre-specified|Number of Headaches a Day|the patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period.|one week||||headaches per day||Full Range|Median
1321470|NCT02268058|Other Pre-specified|Headache Intensity Per Day for One Week|The Numerical Rating Scale (NRS) will be used to capture the intensity of the headache experience. The NRS was initially developed for acute post procedural pain and is now a common measure for headache and disease related pain with well established reliability and validity as a self report measure in this age group. Children meeting the inclusion criteria also meet the criteria for self report. The numerical rating scale includes indicators from 0 to 10 with 0 being the ‘no pain’ and 10 being ‘the worst pain ever’. The child when diarizing the headaches will report a pain intensity score for each headache type in their one week headache diary. Study participants and their parent will be given instruction regarding reporting the headache instruction. The headache intensity scores were averaged for the day per participant.|one week||||units on a scale||Full Range|Median
1321471|NCT02268058|Secondary|Percentage of Study Participants That Returned to School at One Week Post Concussion|patients/family were asked if the child returned to school one week after their injury|one week||||percentage of participants|||Number
1321472|NCT02268058|Primary|Number of Headache Days|study participants completed a one week diary at home stating if they had headaches.|one week||||number of headache days||Full Range|Mean
1321473|NCT02267850|Primary|Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.|The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.|Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.||||months||Standard Deviation|Mean
1321474|NCT02267837|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.||||millimeters per week (mm/wk)|arches|Standard Deviation|Mean
1321475|NCT02267824|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.||||millimeters per week (mm/wk)||Standard Deviation|Mean
1321476|NCT02267629|Secondary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 4 Weeks||||Participants|||Count of Participants
1321477|NCT02267629|Primary|Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.|Patients self-rated the severity of their obsessions and compulsions using the YBOC Challenge Scale, a 10-item self-report form that assesses Obsessive Compulsive Disorder (OCD) symptoms (i.e., time spent, degree of control, severity) [total score range = 0 – 40 ] over the previous 60 minutes. The higher the number on the YBOCCS, the more severe the symptoms.|Baseline and 230 minutes post infusion||||units on a scale||Standard Deviation|Mean
1321478|NCT02267538|Other Pre-specified|Length of Stay in Hospital After Surgery|Results was presented as median (95% confidence interval).|From end of surgery until discharge from hospital or 30 days after surgery||||days||95% Confidence Interval|Median
1321479|NCT02267538|Other Pre-specified|Length of Stay in the Intensive Care Unit|Results was presented as median (95% confidence interval).|From end of surgery until discharge from Intensive Care Unit or 30 days after surgery||||hours||95% Confidence Interval|Median
1321480|NCT02267538|Other Pre-specified|Subjective Sleep Quality|Subjective sleep quality was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = best sleep, 10 = the worst possible sleep).|During the first five days after surgery||||units on a scale||Inter-Quartile Range|Median
1321481|NCT02267538|Other Pre-specified|Pain Intensity|Pain intensity was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = no pain, 10 = the worst possible pain).|During the first five days after surgery||||units on a scale||Inter-Quartile Range|Median
1321482|NCT02267538|Secondary|Incidence of Non-delirium Complications After Surgery|Non-delirium complications was defined as any conditions other than delirium that occurred during the first 30 days after surgery and required therapeutic intervention.Complications listed here were not considered adverse events in this study.|Occurrence of non-delirium complications will be monitored until 30 days after surgery.||||Participants|||Count of Participants
1321483|NCT02267538|Secondary|Cognitive Function|"Cognitive function was assessed with the Mini Mental State Examination (MMSE) at baseline (the day before surgery) and on the sixth day after surgery, and with modified telephone interview for cognitive status (m-TICS) on the 30th day after surgery.~The introduction of MMSE scale has been explained in the baseline part in the result section.~The Telephone Interview for Cognitive Status-modified scale(m-TICS) is one of the most popular telephone interview-based screening instruments for mild cognitive impairment and dementia. It consists 11 items including wordlist memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis, which score ranges from 0 to 48, with higher scores indicating better cognitive function"|on the sixth day after surgery, and on the 30th day after surgery|5 patients (3 in CTRL group and 2 in DEX group) did not complete the MMSE test on postoperative day 6;17 patients (12 in CTRL group and 5 in DEX group) did not complete the m-TICS test on postoperative day 30|||units on a scale||Inter-Quartile Range|Median
1321484|NCT02267538|Primary|Incidence of Postoperative Delirium|Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery.|During the first five days after surgery||||Participants|||Count of Participants
1321485|NCT02267447|Other Pre-specified|Death Due to Causes Other Than CVD||up to 12 years||||deaths|||Number
1321790|NCT02258373|Secondary|Percentage of Time With Sensor Value <70 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
1321486|NCT02267447|Primary|Major Cardiovascular Disease Event|The primary outcome of interest was a major CVD event resulting in hospitalization or sudden death from CVD. Respondents were followed from the survey administration date until the earliest of: incident event, death due to causes other than CVD (defined as a competing risk), loss to follow-up (defined as loss of health care eligibility), or end of study (31 December 2012).|up to 12 years||||Cardiovascular disease event|person-years||Number
1321487|NCT02267187|Secondary|Assessment of Cellular Properties of the Cells Within the Fat Graft|Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft.|Assessed at time of operative procedure||||percentage of ASCs within the SVF||Standard Deviation|Mean
1321488|NCT02267187|Primary|Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative.|Facial volume appearance is based on the established Facial Volume Appearance Scale (FVAS). The scale is from 1-3 where 1 indicates no improvement and 3 indicates noticeable improvement of facial volume appearance.|screen, 7-21 days, 3, and 9 months post-operative||||units on FVAS scale||Standard Deviation|Mean
1321489|NCT02267187|Primary|Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.||Assessed at 7-21 days, 3 months, 9 months||||milliliters||Standard Deviation|Mean
1321490|NCT02267135|Secondary|Change From Baseline in Subject Assessment of Scaling (Scalp Only)|"Change from baseline in the Subject Assessment of Scaling (scalp only)~Scale of 0-10 with 10 being the most scaling"|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
1321491|NCT02267135|Secondary|Change From Baseline in Subject Assessment of Itching|"Change from baseline in the Subject Assessment of Itching~Scale of 0-10 with 10 being the most itchy"|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
1321492|NCT02267135|Secondary|Change From Baseline in Subject Assessment of Pain|"Change from baseline in the Subject Assessment of Pain~Scale of 0-10 with 10 being the most painful"|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
1321493|NCT02267135|Secondary|Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)|IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
1321494|NCT02267135|Secondary|Psoriasis Area and Severity Index 100 (PASI 100)|PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis|12 weeks||||Percent of Participants|||Number
1321495|NCT02267135|Secondary|Psoriasis Area and Severity Index 90 (PASI 90)|PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
1321496|NCT02267135|Secondary|Psoriasis Area and Severity Index 75 (PASI 75)|PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis|12 weeks|Full Analysis Set|||Percent of participants|||Number
1321497|NCT02267135|Secondary|Time to 50% Reduction in PSSI Score up to Week 12|"Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm~The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo"|12 weeks|Full Analysis Set|||weeks||95% Confidence Interval|Median
1321498|NCT02267135|Secondary|Psoriasis Scalp Severity Index 100 (PSSI 100) Response|PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
1321499|NCT02267135|Secondary|Psoriasis Scalp Severity Index 75 (PSSI 75) Response|PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
1321500|NCT02267135|Secondary|Change From Baseline in PSSI Score|Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
1321501|NCT02267135|Secondary|Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)|IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
1321502|NCT02267135|Primary|Psoriasis Scalp Severity Index 90 (PSSI 90)|"PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis~Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of yes"|12 weeks|Full Analysis Set|||Percent of Participants|||Number
1321503|NCT02267083|Other Pre-specified|Number of Subjects With Tumor Response Per RECIST 1.1|Tumor assessments using contrast enhanced computerized tomography (CT) scan of the Chest/Abdomen/Pelvis were performed to assess overall tumor burden. Response rate (RR), where response is defined as complete response (CR), partial response (PR), or stable disease (SD). Determination of CR or PR requires confirmation at the time of the next tumor assessment. An outcome of SD requires at least one assessment 6 weeks after the initiation of dosing. Progression is defined using RECIST 1.1, as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Assessed during screening, then every 6 weeks for the first 24 weeks on study, and then every 9 weeks for the next 24 weeks for up to 1 year. Subjects will be in the study for up to 1 year, or until disease progression or unacceptable toxicity.|An on-study tumor assessment was done on 19 subjects within the ITT population; 2 subjects died before having a RECIST 1.1 measurement.|||Participants|||Count of Participants
1321504|NCT02267083|Secondary|Number of Subjects Experiencing Adverse Events|Subjects who received at least one dose were included in safety analyses. Adverse events were tabulated by System Organ Class (SOC) and Preferred Term (PT) and coded using MedDRA Version 19.1. Safety and tolerability was determined by frequency, nature, and severity of adverse events and the profile of toxicities.|From the beginning of study treatment and up to 12 months|Subjects who received at least one dose of GPX-150 were included in the safety analyses.|||Participants|||Count of Participants
1323744|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|3 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1321505|NCT02267083|Secondary|Number of Subjects Progression-free at Six Months Per RECIST 1.1|This secondary efficacy endpoint is the progression-free rate (PFR) at 6 months, obtained from the Kaplan-Meier curve for progression-free survival (PFS).|6 months from the beginning of the study treatment|Consists of all subjects in the safety population who had at least one on-study tumor assessment using RECIST 1.1 (19 subjects). One subject withdrew consent before first on-study tumor assessment and two subjects died before first on-study tumor assessment.|||Participants|||Count of Participants
1321506|NCT02267083|Primary|Number of Subjects Progression-free at 12 Months Per RECIST 1.1|The primary efficacy endpoint is the number of patients who were progression-free at 12 months, which is obtained by inversion of the Kaplan-Meier curve for progression-free survival (PFS) at 12 months. Of note, the statistical comparison to historical sarcoma data described in the protocol was not performed due to an enrollment of less than the planned sample size of 30 subjects. Progression is defined using RECIST 1.1, as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|12 months from the beginning of study treatment|Consists of all subjects in the safety population (22 subjects) and who had at least one on-study tumor assessment using RECIST 1.1 (19 subjects). One subject withdrew consist before first on-study tumor assessment and two subjects died before first on-study tumor assessment.|||Participants|||Count of Participants
1321507|NCT02266875|Secondary|30 Day All Cause Mortality|Documented mortality at 30 days post discharge|30 days post discharge||||Participants|||Count of Participants
1321508|NCT02266875|Secondary|30 Day Readmission|Documented hospital readmission 30 days post discharge|30 days post discharge||||Participants|||Count of Participants
1321509|NCT02266875|Primary|Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale|"This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein 0 indicates no difficulty breathing, and 10 indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates very, very slight (just noticeable) difficulty in breathing.~A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing."|Pre-treatment (baseline) vs. 24 hours post-treatment||||units on a scale||Standard Deviation|Mean
1321510|NCT02266810|Secondary|Occlusion/Restenosis (Propel Nova Cohort)|"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:~0=Patent~Restenosed/Partially Occluded~Occluded"|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
1321511|NCT02266810|Secondary|Inflammation (Propel Nova Cohort)|The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.|Day 30||||100-mm VAS|sinus sides|Standard Deviation|Mean
1321512|NCT02266810|Secondary|Need for Surgical Interventions (Propel Nova Cohort)|"Need for Surgical Interventions by clinical investigators at Day 30~Need for Surgical Interventions by clinical investigators at Day 30.~Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.~Adhesions/Scarring was assessed based on a 4-point scale as follows:~0= No visible granulation/scarring in the FSO~Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)~Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)~Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)"|Day 30||||percentage of evaluable sinuses|sinus sides||Number
1321513|NCT02266810|Secondary|Need for Post-operative Interventions (Propel Nova Cohort)|"Need for post-operative interventions by clinical investigators at Day 30.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
1321514|NCT02266810|Secondary|Occlusion/Restenosis (Propel Mini Cohort)|"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:~0=Patent~Restenosed/Partially Occluded~Occluded"|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
1321515|NCT02266810|Secondary|Inflammation (Propel Mini Cohort)|The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.|Day 30||||100-mm VAS|sinus sides|Standard Deviation|Mean
1321516|NCT02266810|Secondary|Need for Surgical Interventions (Propel Mini Cohort)|"Need for Surgical Interventions by clinical investigators at Day 30.~Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.~Adhesions/Scarring was assessed based on a 4-point scale as follows:~0= No visible granulation/scarring in the FSO~Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)~Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)~Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)"|Day 30||||percentage of evaluable sinuses|sinus sides||Number
1321517|NCT02266810|Secondary|Need for Post-operative Interventions (Propel Mini Cohort)|"Need for post-operative interventions by clinical investigators at Day 30~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
1321534|NCT02266381|Secondary|Perioperative Complications|Complication is defined as any adverse event occurred intraoperatively or ≤ 30 days postoperatively. Complications included fever, systemic Inflammatory Response Syndrome, septic shock, extravasations, bleeding necessitating transfusion, and sever bleeding necessitating selective renal artery embolization.|intraoperatively or ≤ 30 days postoperatively||||Participants|||Number
1321518|NCT02266810|Primary|Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)|"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|Of the 80 patients who had their endoscopy recorded at day 30 for grading by independent reviewer; 19 patients could not be included in the test due to missing data. Data were considered missing if the independent reviewer could not grade a video on one or both treatment sinus sides.|||percentage sinus requiring intervention||95% Confidence Interval|Number
1321519|NCT02266810|Primary|Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)|"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|ITT population|||percent sinuses requiring intervention||95% Confidence Interval|Number
1321520|NCT02266797|Secondary|Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.|The outcomes of surgery will be examined through the 1 year post-operative appointment.|12 months|Data not available due to premature halting of study||||||
1321521|NCT02266797|Secondary|Examine the Impact of Dexamethasone on Radicular Pain.|This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.|12 months|Data not available due to premature halting of study||||||
1321522|NCT02266797|Secondary|Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.|This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.|Immediate post-operatively|Data not available due to premature halting of study||||||
1321523|NCT02266797|Secondary|The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.|Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.|12 months|Data not available due to premature halting of study||||||
1321524|NCT02266797|Primary|The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.|Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.|12 months|Data not available due to premature halting of study||||||
1321525|NCT02266797|Primary|Intravenous Corticosteroids Effect on Post-operative Dysphagia|The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.|12 months|Data not available due to premature halting of study||||||
1321526|NCT02266472|Secondary|AUC0-infinity of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1321527|NCT02266472|Secondary|AUC0-infinity of Empagliflozin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1321528|NCT02266472|Primary|Cmax of Metformin in Plasma|Maximum measured concentration of the metformin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1321529|NCT02266472|Primary|Cmax of Empagliflozin in Plasma|Maximum measured concentration of the empagliflozin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1321530|NCT02266472|Primary|AUC0-tz of Metformin in Plasma|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1321531|NCT02266472|Primary|AUC0-tz of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|Pharmacokinetic set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1321532|NCT02266381|Secondary|Change in Hemoglobin Concentration|Change in hemoglobin concentration is assessed by comparing the preoperative hemoglobin level with 24-hour postoperative hemoglobin level.|within 24 hours after MPCNL||||g/L||Standard Deviation|Mean
1321533|NCT02266381|Secondary|Operation Time|Operation time is defined as the time from puncture to the placement of the nephrostomy tube.|intraoperatively||||min||Standard Deviation|Mean
1321535|NCT02266381|Primary|Stone Free Rate|Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter >4 mm.|one day after MPCNL||||Participants|||Number
1321536|NCT02266277|Other Pre-specified|Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR)|We calculated the percent of patients who used the portal or IVR to self-report influenza vaccine completion outside of the medical group, measured on April 1, 2015. We used as our denominator all those patients who received portal messages (10,000) and all those who received IVR calls (15,000).|Months 11-16||||Participants|||Count of Participants
1321537|NCT02266277|Secondary|Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Months 11-16||||Participants|||Count of Participants
1321538|NCT02266277|Primary|Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season|To determine the impact of our interventions on influenza vaccine completion for the 2014-15 influenza season, we calculated frequencies and performed intention-to-treat bivariate analyses of randomized patients (30,000 patients), assessing whether randomization group was associated vaccine completion. Due to differential rates of vaccination at baseline between portal users and non-users, analyses in these groups were conducted separately. We then performed multivariate logistic regression analyses. We created dummy variables for assignment to the portal message arm (among portal users) and for assignment to the Interactive Voice Recognition (IVR) call arm (among both portal users and, separately, among non-portal users). Including these dummy variables and adjusting for demographic and practice-level covariates, we modeled the odds of receiving an influenza vaccine in the 2014-15 influenza season.|Months 11-16|Using computer-generated random number assignments, we selected 20,000 portal users and 10,000 non portal users (total of 30,000 patients) from the eligible population.|||Participants|||Count of Participants
1321539|NCT02265848|Other Pre-specified|Preferability|At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one.|End of treatment visit on visit 4|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||participants|||Number
1321540|NCT02265848|Secondary|Patient's Global Impression of Change (PGIC)|PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||units on a scale||Full Range|Mean
1321541|NCT02265848|Secondary|Oswestry Disability Index Questionnaire (ODI).|ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||units on a scale||Full Range|Mean
1321542|NCT02265848|Primary|Numeric Pain Rating Scale (NPRS)|Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||units on a scale||Full Range|Mean
1321543|NCT02265796|Secondary|Ischemia Driven Revascularization or Hospitalization|Number of participants who reported adverse events for ischemia driven revascularization or hospitalization|4 month|the incidence of ischemia driven hospitalization or catheterization was assessed for all subjects.|||Participants|||Count of Participants
1321544|NCT02265796|Secondary|Subjective Well Being|overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4|Compare from baseline to month 4||||Participants|||Count of Participants
1321545|NCT02265796|Primary|Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks|"The SAQ quantifies patients’ physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated.~Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."|Change in baseline to 16 weeks|by intention to treat, 46 subjects had baseline and follow up SAQ data completed at 16 weeks|||units on a scale||Standard Deviation|Mean
1321563|NCT02263911|Primary|PK: Maximum Concentration (Cmax) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1321564|NCT02263911|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1321546|NCT02265783|Primary|"Report the Time Until the Device Posts Sensor Off After the Sensor is Removed"|A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend – Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.|1 minute per event, multiple events per subject. Total duration up to 1 hour|20 subjects participated. There were errors with the data collection device for one subject and the data was unusable.|||Percent||95% Confidence Interval|Mean
1321547|NCT02265237|Secondary|Percentage of Participants in Arms A, B and C With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1321548|NCT02265237|Secondary|Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA >= LLOQ with at least 6 weeks of treatment.|Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1321549|NCT02265237|Secondary|Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
1321550|NCT02265237|Secondary|Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
1321551|NCT02265237|Primary|Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||97.5% Confidence Interval|Number
1321552|NCT02264977|Secondary|Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab|Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (endoleak type IA or IB) OR the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (type III endoleak).|1 month post procedure|Two participants not assessed for endoleaks at 1 month.|||Participants|||Count of Participants
1321553|NCT02264977|Secondary|Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab||1 month post procedure|One participant not assessed for patency at 1 month.|||Participants|||Count of Participants
1321554|NCT02264977|Primary|Number of Participants With Primary Procedural Side Branch Patency|The presence of forward flow through the implanted Side Branch Component into the target branch vessel.|At conclusion of the treatment procedure (day 0)||||Participants|||Count of Participants
1321555|NCT02264977|Primary|Number of Participants With Successful Study Device Deployment|Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.|During treatment procedure (day 0)||||Participants|||Count of Participants
1321556|NCT02264977|Primary|Number of Participants With Successful Study Device Access|Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.|During treatment procedure (day 0)||||Participants|||Count of Participants
1321557|NCT02264821|Primary|Morphine Consumption|Morphine consumption with PCAIV|30 hours after spinal injection T0||||milligrammes||Inter-Quartile Range|Median
1321558|NCT02264821|Secondary|Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.|Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?|30 hours after spinal injection|||||||
1321559|NCT02264821|Primary|Duration of Effective Analgesia|T0 until first request of morphine PCAIV|30 hours after spinal injection T0||||minutes||Inter-Quartile Range|Median
1321560|NCT02264249|Secondary|Procedure Complications (Decrease in Oxygen Saturation)|The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.|1 day||||participants|||Number
1321561|NCT02264249|Secondary|pH of Gastric Fluid of Different Bowel Preparation Regimens|The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day||||pH||Standard Deviation|Mean
1321562|NCT02264249|Primary|Residual Gastric Volumes of Different Bowel Preparation Regimens|The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day||||mL||Standard Deviation|Mean
1321565|NCT02263911|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1321566|NCT02263833|Other Pre-specified|Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL||Up to 4 years|||||||
1321567|NCT02263833|Other Pre-specified|Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion||Up to 4 years|||||||
1321568|NCT02263833|Primary|Percentage of Participants With an Adverse Drug Reaction (ADR)|ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as “definitely related”,“probably related”, “possibly related”, and “unknown” by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as “Unexpected”. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera.|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.|||percentage of participants|||Number
1321569|NCT02263833|Primary|Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event|An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.|||percentage of participants|||Number
1321570|NCT02263365|Other Pre-specified|Length of Index Admission||30 day|Data was not collected.||||||
1321571|NCT02263365|Secondary|Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care||30 days|Data was not collected.||||||
1321572|NCT02263365|Secondary|Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission||30 day|Data was not collected.||||||
1321573|NCT02263365|Primary|Incidence of 30 Day Readmission (Severe Dehydration)||30 day|Data was not collected.||||||
1321574|NCT02263131|Secondary|Percentage of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, and a Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer||Day28(+7)|||||||
1321575|NCT02263131|Secondary|GMR of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)|||||||
1321576|NCT02263131|Secondary|GMT of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)|||||||
1321577|NCT02263131|Secondary|Physical Examination Finding, Vital Signs||Day28(+7)|||||||
1321578|NCT02263131|Primary|Percentage of Subjects Achieving Seroconversion and Seroprotection for HI Antibody After Administration of the Study Vaccine|Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2), * Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40|up to Day28(+7)||||percentage of participants||95% Confidence Interval|Number
1321579|NCT02263131|Primary|Solicited Local & General Adverse Event, Unsolicited Adverse Event|Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia|up to Day28(+7)||||percentage of paticipants||95% Confidence Interval|Number
1321580|NCT02263118|Secondary|Mean Change in Weight-for-Age Z-score|"We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.~We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies."|Baseline at December 2013 and 23 weeks later in May 2014||||z-score||95% Confidence Interval|Mean
1321581|NCT02263118|Secondary|Number of Text-messages Exchanged in Virtual Communities|We were interested in the activity of virtual communities in terms of sent text-messages.|December 2013 - May 2014, 23 weeks|"In virtual communities, participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the hybrid setup, participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional."|||Number of text messages|||Number
1321582|NCT02263118|Secondary|Qualitative Nature of Health-related Text-messages|Specifically, we were interested in classifying individual text-messages as social support or health related.|December 2013 - May 2014, 23 weeks||||Number of text messages|Participants||Number
1321791|NCT02258373|Secondary|Measures of Glycemic Variability: Coefficient of Variation|Coefficient of variation = SD/mean|Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percent||Inter-Quartile Range|Median
1321583|NCT02263118|Primary|Number of Participants With Changes in Knowledge|Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).|December 2013 - May 2014, 23 weeks||||participants|||Number
1321584|NCT02262754|Secondary|Plasma Concentration of Naproxen|Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||ng/mL||Standard Deviation|Mean
1321585|NCT02262754|Secondary|Plasma Concentration of PF-06372865|Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||ng/mL||Standard Deviation|Mean
1321586|NCT02262754|Secondary|Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4|Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.|Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
1321587|NCT02262754|Secondary|Patient Global Impression of Change (PGI-C) Score|PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||90% Confidence Interval|Least Squares Mean
1321588|NCT02262754|Secondary|Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4|Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||90% Confidence Interval|Least Squares Mean
1321589|NCT02262754|Secondary|Chronic Low Back Pain (CLBP) Responder Index Analysis|Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.|Week 1, 2, 3, 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
1321590|NCT02262754|Secondary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4|This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.|Baseline, Week 2, Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||Standard Deviation|Mean
1321591|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||units on a scale||90% Confidence Interval|Mean
1321592|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 1, 2, 3|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||Standard Deviation|Mean
1321593|NCT02262754|Secondary|Amount of Rescue Medication Used by the Participants|The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||mg||Standard Deviation|Mean
1321594|NCT02262754|Secondary|Number of Days Participants Used the Rescue Medication|The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||days||Standard Deviation|Mean
1321616|NCT02262728|Secondary|Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)||Follow-up Week 24 (Week 36)|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units per Liter (U/L)||Standard Deviation|Mean
1321595|NCT02262754|Secondary|Number of Participants Using Rescue Medication|Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||participants|||Number
1321596|NCT02262754|Secondary|Time to Withdrawal Due to Lack of Efficacy|"Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as Insufficient Clinical Response. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization."|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||days||90% Confidence Interval|Median
1321597|NCT02262754|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy|Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
1321598|NCT02262754|Secondary|Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
1321599|NCT02262754|Secondary|Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||percent change||Standard Deviation|Mean
1321600|NCT02262754|Secondary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||90% Confidence Interval|Least Squares Mean
1321601|NCT02262754|Primary|Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit|PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.|End of treatment (Day 30), follow-up (Day 44)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||units on a scale||90% Confidence Interval|Least Squares Mean
1321602|NCT02262754|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior =3 (“Yes” on “preparatory acts or behavior”), suicidal ideation =4 (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Screening, Baseline, Week 1, 2, 3, 4|Data was not collected for this outcome measure as per study team’s decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.||||||
1321603|NCT02262754|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Follow-up (44 days)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, n signifies the number of participants evaluable for the specific category."|||participants|||Number
1321604|NCT02262754|Primary|Number of Participants With Vital Sign Abnormalities|Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Baseline up to Follow-up (44 days)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1321605|NCT02262754|Primary|Number of Participants With Laboratory Abnormalities|Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).|Baseline up to 28 days after the last dose of study treatment (Day 56)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
1321606|NCT02262754|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 28 days after the last dose of study treatment (Day 56)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1321607|NCT02262754|Primary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4|Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||units on a scale||90% Confidence Interval|Mean
1321608|NCT02262728|Secondary|Percentage of Participants With SVR12 Who Maintain to Have HCV RNA <LLOQ Until the End of 5 Years Follow up|Percentage of participants with SVR12 who continue to have HCV RNA <LLOQ (15 IU/mL) will be reported after the completion of the follow-up phase.|Week 24 up to Week 276||2021-01-31|01/2021||||
1321609|NCT02262728|Secondary|Percentage of Participants With Viral Relapse|Viral relapse is defined as participants who do not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ (15 IU/mL) at Week 16, 24 or 36.|Week 16, 24 and 36|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint (viral relapse) analysis was zero.||||||
1321610|NCT02262728|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1321611|NCT02262728|Secondary|Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The C0h is the pre-dose plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1321612|NCT02262728|Secondary|Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmin is the minimum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.|||ng/mL||Standard Deviation|Mean
1321613|NCT02262728|Secondary|Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmax is the maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.|||nanogram per Millilieters (ng/mL)||Standard Deviation|Mean
1321614|NCT02262728|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.|||ng.h/mL||Standard Deviation|Mean
1321615|NCT02262728|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|Tmax is the time to reach maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analysed for this outcome measure at specific time point.|||Hours||Full Range|Median
1327858|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12||Baseline, Week 12|Due to changes in planned analyses the data was not collected for this outcome measure.||||||
1321617|NCT02262728|Secondary|Percentage of Participants With HCV NS3/4A Sequence, NS5A and NS5B After End of Treatment in Participants Not Achieving SVR|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. All subjects in this study achieved SVR12. Therefore, reasons for not achieving SVR12 are not applicable.|Baseline, Day 3, Week 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and Year 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 after end of treatment|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint analysis was zero.||||||
1321618|NCT02262728|Secondary|Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)|Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was <LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.|Week 16 and Week 36|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here , 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Percentage of Participants||95% Confidence Interval|Number
1321619|NCT02262728|Secondary|Percentage of Participants With On-Treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: <LLOQ undetectable, <LLOQ detectable, and <LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment.|Week 1, 2, 4, 6, 8, 10, 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Percentage of Participants|||Number
1321620|NCT02262728|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.|Week 24|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1321621|NCT02262078|Primary|Change in Pulmonary Capillary Wedge Pressure During Exercise|Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured in millimeters of mercury (mmHg)|Baseline, after study drug dosing, approximately 4 minutes after starting exercise||||millimeters of mercury||Standard Deviation|Mean
1321622|NCT02262039|Secondary|Mean ETCO2|mean End-tidal carbon dioxide concentration in the expired air|intraoperative||||mmHg||Standard Deviation|Mean
1321623|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|12 hours post-op||||units on a scale||Standard Deviation|Mean
1321624|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.|6 hours post-op||||units on a scale||Standard Deviation|Mean
1321625|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|1 hour post-op||||units on a scale||Standard Deviation|Mean
1321626|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalent - mean in mg|Operative and Post-operative (until time of discharge, typically 2-4 days)||||mg||Standard Deviation|Mean
1321627|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Post-operative (until time of discharge, typically 2-4 days)||||mg||Standard Deviation|Mean
1321628|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Intra-Operative on day of surgery||||mg||Standard Deviation|Mean
1321629|NCT02261974|Secondary|Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)|"The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a worse outcome. The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening."|6 months|This population consists of all randomized subjects who completed a 6 month assessment.|||Units on a Scale||Standard Error|Mean
1321630|NCT02261974|Secondary|Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)|Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1–7 where 1 = “Very Loose” and 7 = “Very Tight”. The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit.|6 months|This population consists of all randomized subjects who completed a 6 month assessment.|||Units on a Scale||Standard Error|Mean
1321644|NCT02261493|Secondary|Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest|The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest|||Percentage of Subjects||95% Confidence Interval|Number
1327907|NCT02134925|Secondary|Adenoma Recurrence Rate Assessed Using Surveillance Exams||Up to 3 years||2019-11-30|11/2019||||
1321631|NCT02261974|Secondary|Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score|Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent’s concern with the perception of laxity (“looseness”) and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient’s experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient’s partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning.|6 months|This population consists of all randomized subjects with a 6 month assessment.|||Units on a Scale||Standard Error|Mean
1321632|NCT02261974|Primary|Reporting Adverse Events (AEs)|Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.|6 months|"Table includes treatment-emergent adverse events (AEs), defined as AEs that began or worsened in severity after treatment.~This population consists of all subjects who were randomized and who received a complete or partial treatment."|||Participants|||Count of Participants
1321633|NCT02261974|Primary|Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score|The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item’s score can range from 0–5 (or 1–5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.|6 months|This population consists of all randomized subjects who completed the six month assessment.|||Units on a Scale||Standard Error|Mean
1321634|NCT02261948|Secondary|Change in DLCO (Diffusion Lung CO)|Levosimendan induced changes on DLCO ( Diffusion Lung CO). DLCO is measured by the single breath-constant expiratory flow technique (Sensor Medics 2200, Yorba Linda, CA) and we calculate also the DLCO adjusted for hemoglobin. Dilution of CH4 is used to measure alveolar volume.|48 hours||||ml/mmHg/min||Standard Deviation|Mean
1321635|NCT02261948|Secondary|Changes in VE/VCO2|Levosimendan induced changes on VE/VCO2 (VE: Expired Volume - VCO2: carbon dioxide production) relationship|48 hours||||VE/VCO2 Slope||Standard Deviation|Mean
1321636|NCT02261948|Primary|Change in Peak VO2 (Oxygen Consumption )|Primary endpoints: Levosimendan induced changes in peak VO2 (Oxygen consumption )|48 hours||||ml/kg/min||Standard Deviation|Mean
1321637|NCT02261818|Primary|Depression With PHQ-9|PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.|at 8 weeks|Patient participants|||units on a scale||Standard Deviation|Mean
1321638|NCT02261805|Secondary|Objective Response Rate|Objective response rate included the count of confirmed complete responses (CR) and partial responses (PR) and was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|2 years||||Participants|||Count of Participants
1321639|NCT02261805|Primary|Maximum Tolerated Dose|The dose of ganetespib at which 1 or more out of 3-6 patients experiences a dose-limiting toxicity|1 year||||mg/m^2|||Number
1321640|NCT02261493|Secondary|Time to Retreatment Eligibility|Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.|12 Months|Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation|||Days||Standard Deviation|Median
1321641|NCT02261493|Secondary|Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©|"The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is I look older than my actual age because of my facial lines with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis."|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11|||Percentage of Subjects||95% Confidence Interval|Number
1321642|NCT02261493|Secondary|Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points|The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject’s appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ|||Percentage of Subjects||95% Confidence Interval|Number
1321643|NCT02261493|Secondary|Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5|"The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks How satisfied are you with the effect your treatment had on your facial lines? Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported."|Day 60|Intent-to-Treat: all randomized subjects with data reported at this time point|||Percentage of Subjects||95% Confidence Interval|Number
1321659|NCT02261428|Secondary|Time to Entering Trachea|We count the required time needed to insert catheter into trachea (seconds).|An average of 15 seconds|The 19 interventions with each catheter was used randomly|||Sec||Standard Deviation|Mean
1321645|NCT02261493|Secondary|Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation|"The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of none and mild are reported."|Day 30|"Intent-to-Treat: all randomized subjects with a score of none and mild on the FWS at maximum eyebrow elevation"|||Percentage of Subjects||95% Confidence Interval|Number
1321646|NCT02261493|Primary|Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation|The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects|||Percentage of Subjects||95% Confidence Interval|Number
1321647|NCT02261467|Secondary|Time to Retreatment Eligibility|Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.|12 Months|Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation|||Days||Standard Deviation|Median
1321648|NCT02261467|Secondary|Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©|"The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is I look older than my actual age because of my facial lines with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis."|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11|||Percentage of Subjects||95% Confidence Interval|Number
1321649|NCT02261467|Secondary|Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points|The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject’s appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ|||Percentage of Subjects||95% Confidence Interval|Number
1321650|NCT02261467|Secondary|Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5|"The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks How satisfied are you with the effect your treatment had on your facial lines? Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported."|Day 60|Intent-to-Treat: all randomized subjects with data reported at this time point|||Percentage of Subjects||95% Confidence Interval|Number
1321651|NCT02261467|Secondary|Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest|The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest|||Percentage of Subjects||95% Confidence Interval|Number
1321652|NCT02261467|Secondary|Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation|"The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of none and mild are reported."|Day 30|"Intent-to-Treat: all randomized subjects with a score of none and mild on the FWS at maximum eyebrow elevation"|||Percentage of Subjects||95% Confidence Interval|Number
1321653|NCT02261467|Primary|Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation|The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects|||Percentage of Subjects||95% Confidence Interval|Number
1321654|NCT02261428|Secondary|Presence of Blood on Catheter Immediately After Each Intervention|Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).|Within 2 seconds after catheter withdrawal.||||Catheters with presence of blood|||Number
1321655|NCT02261428|Secondary|Diastolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the diastolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.||||mmHg||Standard Deviation|Mean
1321656|NCT02261428|Secondary|Systolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the systolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.||||mmHg||Standard Deviation|Mean
1321657|NCT02261428|Secondary|Heart Rate Immediately After Intervention|Immediately after each intervention recorded the heart rate (beats per minute).|Within 2 seconds after catheter withdrawal.||||Βeats per minute||Standard Deviation|Mean
1321658|NCT02261428|Secondary|Respiratory Rate Immediately After Intervention|Recorded the respiratory rate (breaths per minute), immediately after intervention|Within 2 seconds after catheter withdrawal.||||Βreaths per minute||Standard Deviation|Mean
1321660|NCT02261428|Primary|Number of Attempts Before Entering Trachea|We count the required attempts to insert catheter into trachea (number of attempts)|An average of 15 seconds||||Attempts||Standard Deviation|Mean
1321661|NCT02260986|Other Pre-specified|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16|ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with ACQ-5 value at baseline.|||units on a scale||Standard Error|Least Squares Mean
1321662|NCT02260986|Other Pre-specified|Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16|The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
1321663|NCT02260986|Secondary|Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52|Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||events|||Number
1321664|NCT02260986|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52|Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||percentage of participants|||Number
1321665|NCT02260986|Secondary|Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52|Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||events|||Number
1321666|NCT02260986|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52|Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = “Infection and Infestations” or SOC = “Skin and Subcutaneous Tissue Disorders”. Blinded adjudication was performed and finalized by the study medical monitor before database lock.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||percentage of participants|||Number
1321667|NCT02260986|Secondary|Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||events|||Number
1321792|NCT02258373|Secondary|Mean Glucose||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||mg/dl||Standard Deviation|Mean
1321668|NCT02260986|Secondary|Number of Flares Through Week 52|Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.|Baseline up to Week 52|All safety analysis were performed on safety analysis set (SAF) that included all randomized participants who received any study drug, and were analyzed as-treated.|||flares|||Number
1321669|NCT02260986|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
1321670|NCT02260986|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52|The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
1321671|NCT02260986|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52|The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
1321672|NCT02260986|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Error|Least Squares Mean
1321673|NCT02260986|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52|SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Error|Least Squares Mean
1321674|NCT02260986|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||Percentage of BSA||Standard Error|Least Squares Mean
1321675|NCT02260986|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Error|Least Squares Mean
1321676|NCT02260986|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
1321793|NCT02258373|Primary|Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Standard Deviation|Mean
1321677|NCT02260986|Secondary|Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52|Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||days||Standard Deviation|Mean
1321678|NCT02260986|Secondary|Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
1321679|NCT02260986|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
1321680|NCT02260986|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
1321681|NCT02260986|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
1321682|NCT02260986|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
1321683|NCT02260986|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percentage of BSA||Standard Error|Least Squares Mean
1321684|NCT02260986|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
1321685|NCT02260986|Secondary|Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
1321693|NCT02260986|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points at Week 52|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of “0” or “1” and a reduction from baseline of ≥2 points at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of participants|||Number
1321686|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.|Baseline to Week 2|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
1321687|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.|Baseline to Week 4|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
1321688|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.|Baseline to Week 24|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
1321689|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.|||percentage of participants|||Number
1321690|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
1321691|NCT02260986|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
1321692|NCT02260986|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of participants|||Number
1321788|NCT02258373|Secondary|Percentage of Time With Sensor Values <50 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
1321694|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.|||percentage of participants|||Number
1321695|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
1321696|NCT02260986|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percentage of participants|||Number
1321697|NCT02260986|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Score of “0” or “1” and Reduction From Baseline of ≥2 Points at Week 16|"IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported."|Baseline to Week 16|All efficacy analyses were performed on the Full Analysis Set (FAS), which included all randomized participants. Efficacy analyses were based on the treatment allocated by interactive voice response system/ interactive web response system (IVRS/IWRS) at randomization (as randomized).|||percentage of participants|||Number
1321698|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Fatigue|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321699|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Headache|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321700|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Arthralgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321701|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Myalgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321702|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Pyrexia|Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321703|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Pain|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321704|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Swelling|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321705|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Erythema|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
1321706|NCT02260882|Secondary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after primary vaccination|Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window|||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
1321707|NCT02260882|Primary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after revaccination|Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window.|||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
1321708|NCT02260791|Other Pre-specified|Trough Adalimumab Concentration|Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).|Week 2, Week 4, Week 12, Week 20, and Week 24|The Pharmacokinetic Analysis Set (PKAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and had at least 1 serum adalimumab concentration result after receiving randomised treatment.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
1321709|NCT02260791|Other Pre-specified|Percentage of Patients Developing Anti-drug Antibodies (ADAs)|Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.|Baseline and last sampling day|The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment. The Safety Analysis Set was used for all safety analyses. Patient safety data were analysed according to treatment actually received.|||percentage of patients|||Number
1321710|NCT02260791|Secondary|DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)|The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.|Baseline, Week 12 and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
1321711|NCT02260791|Secondary|DAS28-CRP Score Over Time|The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
1321789|NCT02258373|Secondary|Percentage of Time With Sensor Values <60 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
1321712|NCT02260791|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
1321713|NCT02260791|Secondary|Patient's Assessment of Pain|An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured (“No pain” at 0 and “Intolerable pain” at 100). Patient's assessment of pain is a value of the individual ACR core set variables.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
1321714|NCT02260791|Secondary|Physician Assessment of Disease Activity|Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
1321715|NCT02260791|Secondary|Patient Assessment of Disease Activity|Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
1321716|NCT02260791|Secondary|Analysis of Serum C-Reactive Protein (CRP) Concentration|Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||mg/L||Standard Deviation|Mean
1321717|NCT02260791|Secondary|Tender Joint Count|Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||Count / Score||Standard Deviation|Mean
1321718|NCT02260791|Secondary|Swollen Joint Count|Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||Count / Score||Standard Deviation|Mean
1321719|NCT02260791|Secondary|ACR70 Response Rates Over Time|"An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||percentage of responders||95% Confidence Interval|Number
1321720|NCT02260791|Secondary|ACR50 Response Rates Over Time|"An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||percentage of responders||95% Confidence Interval|Number
1321721|NCT02260791|Secondary|ACR20 Response Rates Over Time|"An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment.Patients were analysed according to the randomised treatment in the primary analysis.|||percentage of responders||95% Confidence Interval|Number
1321722|NCT02260791|Secondary|Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score|The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient’s RA. A higher score indicates higher disease activity.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
1321723|NCT02260791|Primary|American College of Rheumatology (ACR) 20 Response Rate|"The primary efficacy endpoint was the ACR20 response rate at Week 24.~An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])"|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||Percentage of participants||95% Confidence Interval|Number
1321724|NCT02260492|Secondary|Number of Participants With Adverse Events||From Screen (Day -28) until 1 week post last treatment|One subject who was assigned OT329 SOLIS received placebo treatment kit in error. The mistake was discovered on Day 1 and the patient was removed from the study. The patient was included in the OT329 SOLIS group for the intent-to-treat analysis but was put in the Placebo group for the Safety analysis as defined by the Statisical Analysis Plan.|||Participants|||Count of Participants
1321725|NCT02260492|Primary|FEV1 Trough|Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.|Post-4 weeks of treatment|Intent-to-Treat|||Liters||Standard Deviation|Mean
1321726|NCT02260492|Primary|Area Under the Serial FEV1-time Curve (AUC 0-12h)|Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.|0-12 hours after dosing on Day 1|Intent-to-treat (ITT)|||Liters||Standard Deviation|Mean
1321727|NCT02260440|Secondary|Overall Survival (OS)|Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.|Up to 2 years|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).|||months||95% Confidence Interval|Median
1321728|NCT02260440|Secondary|Progression-free Survival (PFS)|Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).|||months||95% Confidence Interval|Median
1321729|NCT02260440|Primary|Objective Response Rate (ORR)|The objective response rate is estimated by the proportion (percentage) of participants with the best response of complete response (CR), or partial response (PR) by RECIST 1.1 criteria, with corresponding exact 95% confidence limits being reported. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 14 months|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).|||percentage of participants||95% Confidence Interval|Number
1321730|NCT02260401|Secondary|Healthcare Utilization|We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)|24 months||2017-04-30|04/2017||||
1321731|NCT02260401|Primary|Utilization of ESI|We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months|24 months||||number of ESI between 18-24 months||Standard Deviation|Mean
1321732|NCT02260388|Secondary|PROMIS Sleep Disturbance Short Form v1.0 8a|"Higher scores for sleep disturbance represents worse outcome (more sleep disturbance).~T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.~Higher scores equals more of the concept being measured"|12 weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||T-Score||Standard Deviation|Mean
1323745|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|2 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1321733|NCT02260388|Secondary|PROMIS Fatigue Short Form v1.0 8a|"Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population."|12 Weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||T-Score||Standard Deviation|Mean
1321734|NCT02260388|Secondary|PROMIS Pain Interference Short Form v1.0 8a T Score|"Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population."|12 weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||T-Score||Standard Deviation|Mean
1321735|NCT02260388|Secondary|SF12 Health Composite Scores|"SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient’s point of view.~Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.~Scores are calibrated so that 50 is the average score or norm, standard deviation = 10.~Higher scores indicate better health for both mental and physical component summary scores."|12 weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||Norm-Based Standardization Score||Standard Deviation|Mean
1321736|NCT02260388|Primary|Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit|The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions.|12 weeks||||Participants|||Count of Participants
1321737|NCT02259608|Secondary|Cytokine Production Measured by ELISA Compared to Baseline|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens|0 weeks and 2 weeks||||ratio||Full Range|Mean
1321738|NCT02259608|Primary|Cytokine Production Measured by ELISA Compared to Baseline|"Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination.~Baseline is set as 1."|0 weeks and 3 months|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens|||ratio||Full Range|Mean
1321739|NCT02259582|Primary|To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.|Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.|Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.||||Participants|||Count of Participants
1321740|NCT02259400|Secondary|Death||1 month||||participants|||Number
1321741|NCT02259400|Secondary|Late Onset Sepsis||after fifth days of life up 2 month of life||||participants|||Number
1321742|NCT02259400|Secondary|Early Onset Sepsis||5days from birth||||participants|||Number
1321743|NCT02259400|Secondary|Newborns Who Received Multiple Surfactant Doses||10 days||||participants|||Number
1321744|NCT02259400|Secondary|Necrotizing Enterocolitis (NEC)||1 month||||participants|||Number
1321745|NCT02259400|Secondary|Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)||first week of life||||participants|||Number
1321746|NCT02259400|Secondary|Retinopathy of Prematurity (ROP)||3 month of life||||participants|||Number
1321747|NCT02259400|Secondary|Periventricular Leukomalacia (PVL)||3 month of life||||participants|||Number
1321748|NCT02259400|Secondary|Intraventricular Hemorrhage (IVH)||1 month of life||||participants|||Number
1321749|NCT02259400|Secondary|Pneumothorax (PNX)||10 days||||participants|||Number
1321750|NCT02259400|Secondary|Bronchopulmonary Dysplasia (BPD)||36 weeks of postconceptional age or time of discharge|2 newborns died in bipap group|||participants|||Number
1321751|NCT02259400|Secondary|Death||2 month||||participants|||Number
1321752|NCT02259400|Primary|Failure of NIV Support|NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.|10 days||||participants|||Number
1321753|NCT02259400|Primary|Duration of NIV Support|DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT|10 days||||HOURS||Inter-Quartile Range|Median
1321754|NCT02259348|Post-Hoc|Median Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation||||days||Full Range|Median
1321755|NCT02259348|Post-Hoc|Mean of Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation||||days||Standard Deviation|Mean
1321756|NCT02259348|Secondary|Rate of Transplant-related Mortality (TRM)|The cumulative incidence of transplant related mortality will be estimated using Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the competing risk events.|100 days post transplantation|All six participants who received the protocol-defined treatment were evaluable for this analysis. One participant died of a non-transplant related cause (leukemia) prior to day 100. Although this participant did not complete the study to Day 100 post-transplantation, they were still evaluable for TRM.|||participants|||Number
1321757|NCT02259348|Secondary|Incidence and Severity of Chronic GvHD|"The cumulative incidence of chronic GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of chronic GvHD will be described. Chronic GvHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with incidence by severity is given."|one year post transplantation||||participants|||Number
1321758|NCT02259348|Secondary|Incidence and Severity of Acute GvHD|The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|100 days post transplantation|Two of six participants did not experience any acute GvHD.|||participants|||Number
1321759|NCT02259348|Secondary|Overall Survival (OS)|The Kaplan-Meier estimate of OS along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) – date of transplant and all participants surviving at the time of analysis without events will be censored. The number of participants surviving to one-year post-transplantation is given.|one year post transplantation||||participants|||Number
1321760|NCT02259348|Secondary|Event-free Survival (EFS)|The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) – date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.|one year post transplantation||||participants|||Number
1321761|NCT02259348|Secondary|Incidence of Malignant Relapse|The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The number of participants with incidence of malignant relapse is given. Relapse was evaluated using standard WHO criteria for each disease.|one year post transplantation||||participants|||Number
1321762|NCT02259348|Primary|Percentage of Participants Engrafted by Day 42 Post-transplant|To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation||||percentage of participants|||Number
1321763|NCT02258529|Secondary|Changes in Health-Related Quality of Life|Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.||Due to the early termination of the study, data were not available for all participants, and therefore this prespecified analysis was not conducted.||||||
1321764|NCT02258529|Secondary|Overall Survival|Overall survival was defined as the interval from enrollment to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
1321765|NCT02258529|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1321766|NCT02258529|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1321767|NCT02258529|Secondary|Time to Response|Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1321768|NCT02258529|Secondary|Idelalisib Trough and Peak Plasma Concentrations||Predose and 1.5 hour postdose at Weeks 2, 4, and 12|Pharmacokinetic (PK) Analysis Set: all participants in the ITT Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.|||ng/mL||Standard Deviation|Mean
1321769|NCT02258529|Secondary|Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings|The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.|Up to 24 weeks plus 30 days|ITT Analysis Set: all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1321770|NCT02258529|Secondary|Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death||Up to 24 weeks plus 30 days|Intent-to-Treat (ITT) Analysis Set: all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1321771|NCT02258529|Primary|Overall Response Rate|Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1328644|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/μL||Standard Deviation|Mean
1321772|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.|Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.|4 weeks|33 subjects completed the 4 week study.|||percentage of days in a week||Standard Deviation|Mean
1321773|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.|"Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.~Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose."|4 weeks|33 subjects completed the 4 week study.|||percentage of days in a week||Standard Deviation|Mean
1321774|NCT02258477|Primary|Responses to the Control of Eating Questionnaire|"Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked what one food makes it most difficult for you to control eating? and question #10 asked  What time are you particularly vulnerable to this one food. Higher ratings are consistent with a more significant or more frequent outcome.~Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order)."|4 weeks|33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.|||units on a scale||Standard Deviation|Mean
1321775|NCT02258412|Primary|Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas|Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.|On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas||||log(10) transformed CFU||95% Confidence Interval|Mean
1321776|NCT02258373|Secondary|Number of Participants With >=1 Serious Adverse Event Other Than SH|"A serious adverse event is any untoward occurrence that:~Results in death.~Is life-threatening; (a non-life-threatening event which, had it been more severe, might have become life-threatening, is not necessarily considered a serious adverse event).~Requires inpatient hospitalization or prolongation of existing hospitalization.~Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (sight threatening).~Is a congenital anomaly or birth defect.~Is considered a significant medical event by the investigator based on medical judgment."|Between baseline (randomization) and 6 months||||Participants|||Count of Participants
1321777|NCT02258373|Secondary|Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=1.0 mmol/L||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
1321778|NCT02258373|Secondary|Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=0.6 mmol/L||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
1321779|NCT02258373|Secondary|Number of Participants With >=1 Diabetic Ketoacidosis (DKA) Events||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
1321780|NCT02258373|Secondary|Number of Participants With >=1 Severe Hypoglycemia Events||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
1321781|NCT02258373|Secondary|Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event||Between baseline (randomization) and 6 months|Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.|||Participants|||Count of Participants
1321782|NCT02258373|Secondary|Change in HbA1c||Between baseline (randomization) and 6 months|Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.|||mmol/mol||Standard Deviation|Mean
1321783|NCT02258373|Secondary|Percentage of Days With at Least 20 Minutes of Sensor Glucose Values >300 mg/dl||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of days||Inter-Quartile Range|Median
1321784|NCT02258373|Secondary|Percentage of Time With Sensor Values > 300 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
1321785|NCT02258373|Secondary|Percentage of Time With Sensor Values > 250 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
1321786|NCT02258373|Secondary|Percentage of Time With Sensor Values >180 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
1321787|NCT02258373|Secondary|Percentage of Days With at Least 20 Minutes of Sensor Glucose Values <60 mg/dl||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of days||Inter-Quartile Range|Median
1328645|NCT02121795|Secondary|Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis||Week 48|Full Analysis Set|||percentage of participants|||Number
1321794|NCT02258334|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine|Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.|||Titer ratios||95% Confidence Interval|Geometric Mean
1321795|NCT02258334|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1321796|NCT02258334|Secondary|Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1321797|NCT02258334|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.|Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1321798|NCT02258334|Primary|Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1321799|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
1321800|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
1321801|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.||||||
1321802|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
1321803|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
1321804|NCT02257918|Secondary|Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
1321805|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
1321806|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
1321807|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 6|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
1321808|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 1 (Baseline)|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
1321809|NCT02257918|Secondary|Number of Participants With Clinical Cure in Each Study Arm|A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator’s assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator’s assessment was the final adjudicator.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.|||Participants|||Count of Participants
1321810|NCT02257918|Secondary|Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.|||Participants|||Count of Participants
1324764|NCT02196714|Secondary|Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||mmol/L||Full Range|Mean
1321811|NCT02257918|Secondary|Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm|Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
1321812|NCT02257918|Primary|Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.|Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.|Day 1 through Day 31|All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.|||Participants|||Count of Participants
1321813|NCT02257918|Primary|Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.|||Participants|||Count of Participants
1321814|NCT02257684|Secondary|The Immunogenicity of IV Pegcristaspase by Testing Anti-pegcrisantaspase and Anti-PEG Binding and Neutralizing Antibodies||30 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
1321815|NCT02257684|Secondary|The SAA Levels Over Time Following Repeated Administration in Children and Young Adults ALL/LBL and Hypersensitivity to Pegaspargase||30 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
1321816|NCT02257684|Secondary|The Pharmakokinetic (PK) Profile of IV Pegcrisantaspase in Children and Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase. Pharmakokinetic Profiles to be Assessed Are: Half Life, Elimination Rate, Tmax, Cmax, AUC.||14 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
1321817|NCT02257684|Primary|The Serum Asparaginase Activity 14 Days After the First Infusion of Study Drug and the Adverse Events in All Participants.||1 Year|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
1321818|NCT02257684|Primary|The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1||15 days during Course 1|Only 1 of the first 4 patients dosed achieved the predefined serum asparaginase activity (SAA) level above the 0.1 IU/mL therapeutic threshold 14 days following the first IV pegcrisantaspase dose in Course 1 (Primary Objective of the study).|||SAA Level IU/mL|||Number
1321819|NCT02257385|Secondary|Change From Baseline in Weighted Mean (WM) FEV1 Over 0-6 Hour Post-dose at Day 84|BL FEV1 was the mean of the 2 assessments made 30 and 5 min PD on Day 1. WM FEV1 derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1 and 84 using the 0-6 hr post-dose FEV1 measurements collected on that day, which included PD FEV1 (taken 30 and 5 min prior to dosing on Day 1 and the 30 and 5 min reading prior to dosing on Day 84) and post-dose FEV1 measurements at 1, 3 and 6 hr post-dose.WM change from BL was the WM at at the visit minus the BL value. Analysis was performed using a RM model with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1) center group, day, day by BL and day by trt interaction, where day was nominal. Only par with data available at the specified TP were analyzed but all par w/o missing covariate information and with >=1 post-BL measurement were included in the analysis.|Baseline and Day 84|ITT Population|||Liters||Standard Error|Least Squares Mean
1321820|NCT02257385|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the 2 assessments made 30 and 5 minutes (min) pre-dose (PD) on Day 1. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after dosing on Day 84 (at Week 12 + 1 day). Analysis was performed using mixed model repeated measures (RM) with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1), center group, day, day by BL interaction and day by trt interaction, where day was nominal.|Baseline (BL) and Day 85|Per Protocol (PP) Pop: all ITT Pop par who were not full protocol deviators considered to impact efficacy. Only par with data available at the specified time points (TP) were analyzed but all par without (w/o) missing covariate information and with >= 1 post BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1321833|NCT02256891|Other Pre-specified|MRI|"MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.~Higher grades are worse radiographic outcomes."|6 months||||scores on a scale||Standard Deviation|Mean
1321821|NCT02257372|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated by performing six-hour serial spirometry from the pre-dose FEV1 and post-dose FEV1 measurements at 15 minutes, 30 minutes, 1 hour, 3 hours and 6 hours. Baseline FEV1 is the mean of the two assessments made 30 and 5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as weighted mean value on Day 84 minus the Baseline value. Analysis was performed using mixed model repeated measures with covariates of treatment, baseline FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA , smoking status, Day, Day by baseline interaction and Day by treatment interaction, where Day is nominal.|Baseline and Day 84|ITT population|||Liter||Standard Error|Least Squares Mean
1321822|NCT02257372|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 was measured using spirometry. BL FEV1 is the mean of the two assessments made 30 and 5 minutes (min) pre-dose on Day 1.Change from BL was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis was performed using mixed model repeated measures with covariates of treatment, BL FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA, smoking status, Day, Day by BL interaction and Day by treatment interaction, where Day is nominal.|Baseline (BL) and Day 85|Intent-to-treat (ITT) population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only participants with data available at specific timepoint were analyzed.|||Liter||Standard Error|Least Squares Mean
1321823|NCT02256982|Primary|Number of Participants Post Operative/Radiation Therapy Complications|Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.|90 Days||||participants|||Number
1321824|NCT02256969|Primary|Tear Break Up Time (TBUT)|TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.|4 week Time Point||||Seconds||Standard Deviation|Mean
1321825|NCT02256969|Primary|Corneal Fluorescein Staining (CFS)|Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|4 week Time Point||||units on a scale||Standard Deviation|Mean
1321826|NCT02256969|Primary|Symptom Assessment in Dry Eye (SANDE)|A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.|4 week Time Point||||units on a scale||Standard Deviation|Mean
1321827|NCT02256969|Primary|Ocular Surface Disease Index (OSDI)|A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|4 week Time Point||||units on a scale||Standard Deviation|Mean
1321828|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|24 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
1321829|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|6 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
1321830|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|Baseline|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
1321831|NCT02256891|Other Pre-specified|Supraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|24 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
1321832|NCT02256891|Other Pre-specified|Supraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|6 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
1321834|NCT02256891|Other Pre-specified|Spraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|Baseline|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
1321835|NCT02256891|Primary|Return to Function|Western Ontario Rotator Cuff Index|24 months|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a 24 month measure than those that completed the entire study.|||units on a scale||Standard Deviation|Mean
1321836|NCT02256891|Primary|Return to Function|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|6 months||||units on a scale||Standard Deviation|Mean
1321837|NCT02256891|Primary|Return to Function|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|Baseline||||units on a scale||Standard Deviation|Mean
1321838|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1321839|NCT02256553|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, was also an AE.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1321840|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1321841|NCT02256553|Primary|Percentage of Participants Who Experienced at Least One Event of Local Swelling|Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1321842|NCT02256488|Secondary|Number of Subjects With Unsolicited Adverse Events|Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.|Day 1 through day 22|Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination.|||Subjects|||Number
1321843|NCT02256488|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.|Day 1 through day 7 (without 30 min)|Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination|||Subjects|||Number
1329624|NCT02106962|Secondary|Local Infection|After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study|2 months|no local infection in any particioant|||participants||Full Range|Mean
1321844|NCT02256488|Secondary|Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.|"Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).~Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.~HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.~According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%."|Day 22|FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed “as randomized” (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).|||percentages of subjects||95% Confidence Interval|Number
1321845|NCT02256488|Primary|Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.|Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.|Day 22|Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis.|||Titers||95% Confidence Interval|Geometric Mean
1321846|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||Full Range|Median
1321847|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||Full Range|Median
1321848|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - All Participants|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||Full Range|Median
1321849|NCT02256436|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE was assessed.|Up to approximately 20 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1321850|NCT02256436|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants were monitored for the occurrence nonserious AEs for up to 30 days after last dose of study treatment and for serious AEs for up to 90 days after last dose of study treatment. The number of participants who experienced an AE was assessed.|Up to approximately 23 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1321851|NCT02256436|Secondary|ORR Per Modified RECIST - All Participants|ORR per modified RECIST was defined as the percentage of participants in the analysis population who had a Complete Response (irCR: complete disappearance of all lesions [and no new lesions] confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented) or a Partial Response (irPR: decrease in tumor burden ≥50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation). ORR per modified RECIST was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1321885|NCT02255565|Secondary|Clinical Global Impressions-ADHD - Severity|The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|once a week for 6 weeks||||units on a scale||Standard Deviation|Mean
1321852|NCT02256436|Secondary|PFS Per Modified RECIST - All Participants|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per modified (immune-related [ir]) RECIST, progressive disease (irPD) was defined as: increase in tumor burden ≥25% relative to minimum recorded tumor burden confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. PFS per modified RECIST was assessed by blinded independent radiologist review in all randomized participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1321853|NCT02256436|Secondary|ORR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in participants with PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1321854|NCT02256436|Secondary|ORR Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in participants with strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1321855|NCT02256436|Secondary|Objective Response Rate (ORR) Per RECIST 1.1 - All Participants|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1321856|NCT02256436|Primary|PFS Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1321857|NCT02256436|Primary|OS - Participants With PD-L1 Positive Tumors|OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. OS was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1321858|NCT02256436|Primary|PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1321859|NCT02256436|Primary|OS - Participants With Strongly PD-L1 Positive Tumors|OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with a programmed cell death-ligand 1 (PD-L1) combined proportion score (CPS) ≥10% were considered to have a strongly PD-L1 positive tumor status. The OS was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322083|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 48 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1321860|NCT02256436|Primary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1321861|NCT02256436|Primary|Overall Survival (OS) - All Participants|OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1321862|NCT02256358|Primary|Emergence Agitation|The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.|During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes||||participants|||Number
1321863|NCT02256345|Secondary|Change in Aortic Augmentation Index|Percent change in augmentation index, whereas augmentation index at each time point (visit) is defined as the amplitude of the second peak to the first peak of the aortic pulse wave form multiplied by 100: augmentation index = (P2/P1)×100.|Baseline, end of week 1, end of week 2||||Percent change in augumentation index||95% Confidence Interval|Mean
1321864|NCT02256345|Secondary|Change in Mitochondrial Oxidative Capacity for Each Dose|Percent change in oxidative capacity (oxyhemoglobin levels) before and after occlusion|Baseline, end of week 1, end of week 2||||Percent change in oxidative capacity||95% Confidence Interval|Mean
1321865|NCT02256345|Secondary|Change in Vasodilatory Reserve for Each Dose|Percent change in peak vascular resistance from rest to peak exercise|Baseline, end of week 1, end of week 2||||%change in peak vascular resistance||95% Confidence Interval|Mean
1321866|NCT02256345|Primary|Change in Peak Oxygen Uptake (VO2) From Baseline Upto 1 Week of Administration for Each Dose|Peak oxygen uptake (VO2) defined as the average value obtained during the last 30 seconds of exercise.|Baseline, end of week 1, end of week 2||||L/min||95% Confidence Interval|Mean
1321867|NCT02256267|Primary|PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219||Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours|All participants who received at least 1 dose of study drug and have evaluable PK data.|||nanogram x hour per mL (ng x h/mL)||Geometric Coefficient of Variation|Geometric Mean
1321868|NCT02256267|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219||Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours|All participants who received at least 1 dose of study drug and have evaluable PK data.|||nanogram per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
1321869|NCT02256072|Secondary|Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months|Overall satisfaction with the intervention or attention control as measured by the “Satisfaction with Intervention Tool.” Tests will be performed at a two-sided 5% significance level.|baseline, post-intervention, 1 month, and 3 months|Due to errors in the data collection method, it is not possible to summarize the data for reporting.||||||
1321870|NCT02256072|Secondary|Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months|Knowledge of home services score at all follow-up time points as measured by “Understanding of Home Services” assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.|||units on a scale||Standard Deviation|Mean
1321871|NCT02256072|Secondary|Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months|Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.|||units on a scale||Standard Deviation|Mean
1321872|NCT02256072|Secondary|Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months|Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the “Planning Perception” assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.|||units on a scale||Standard Deviation|Mean
1321873|NCT02256072|Primary|Planning Behavior Score at 1-month|The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the “Planning Implementation (Behavior)” assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%.|baseline and 1 month|All randomized participants with a complete planning behavior score at baseline and one-month.|||units on a scale||Standard Deviation|Mean
1321874|NCT02255760|Secondary|Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902|Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.|Days 1 (pre-dose), 15, 29, and 61|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
1321875|NCT02255760|Secondary|MEDI3902 Serum Clearance (CL) of MEDI3902|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||milliliters/day||Standard Deviation|Mean
1321876|NCT02255760|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||milliliters||Standard Deviation|Mean
1321877|NCT02255760|Secondary|Terminal Phase Elimination Half-life (t1/2)|The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Days||Standard Deviation|Mean
1321878|NCT02255760|Secondary|Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose|The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||micrograms/milliliter||Standard Deviation|Mean
1321879|NCT02255760|Secondary|Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||micrograms*day/milliliters||Standard Deviation|Mean
1321880|NCT02255760|Primary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.|Day 1 to Day 7|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
1321881|NCT02255760|Primary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.|Day 1 to Day 29|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
1321882|NCT02255760|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)|An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.|Day 1 to Day 61|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
1321883|NCT02255760|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 to Day 29|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
1321884|NCT02255565|Secondary|Clinical Global Impression - Improvement (CGI-I)|The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.|once a week for 6 weeks||||units on a scale||Standard Deviation|Mean
1321886|NCT02255565|Primary|ADHD Rating Scale - IV|Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.|once a week for 6 weeks||||units on a scale||Standard Deviation|Mean
1321887|NCT02255279|Secondary|Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Percentage of subjects||95% Confidence Interval|Number
1321888|NCT02255279|Secondary|Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to <72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Ratios||95% Confidence Interval|Geometric Mean
1321889|NCT02255279|Secondary|Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Percentages of subjects||95% Confidence Interval|Number
1321890|NCT02255279|Primary|Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.|"Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.~The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007)."|Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Titers||95% Confidence Interval|Geometric Mean
1321891|NCT02255279|Primary|Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22|Number of non-naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.|From Day 1 to Day 22|Analysis performed on the Unsolicited Safety Set.|||Participants|||Number
1321892|NCT02255279|Primary|Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.|Number of naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.|From Day 1 to Day 50|Analysis performed on the Unsolicited Safety Set.|||Participants|||Number
1321893|NCT02255279|Primary|Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of non-naive subjects ≥36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.|||Participants|||Number
1321894|NCT02255279|Primary|Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects ≥ 36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.|||Participants|||Number
1321895|NCT02255279|Primary|Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.|Number of non-naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.|||Participants|||Number
1321896|NCT02255279|Primary|Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.|||Participants|||Number
1321897|NCT02255149|Primary|Bone Height|Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.|5 months||||millimeters||Full Range|Mean
1321898|NCT02255097|Secondary|OS in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for OS. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Months||95% Confidence Interval|Median
1322084|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 36 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1321899|NCT02255097|Secondary|OS in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for OS. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Months||95% Confidence Interval|Median
1321900|NCT02255097|Secondary|Overall Survival (OS) in All Participants|OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication|||Months||95% Confidence Interval|Median
1321901|NCT02255097|Secondary|PFS in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for PFS by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Months||95% Confidence Interval|Median
1321902|NCT02255097|Secondary|PFS in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for PFS. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Months||95% Confidence Interval|Median
1321903|NCT02255097|Secondary|Progression-free Survival (PFS) in All Participants|PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication|||Months||95% Confidence Interval|Median
1321904|NCT02255097|Secondary|DOR in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for DOR based n RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50% and a best overall response as confirmed complete response or partial response|||Months||Full Range|Median
1321905|NCT02255097|Secondary|DOR in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for DOR based on RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1% and a best overall response as confirmed complete response or partial response|||Months||Full Range|Median
1321906|NCT02255097|Secondary|Response Duration (DOR) in All Participants|DOR was based on RECIST 1.1 and measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a best overall response as confirmed complete response or partial response|||Months||Full Range|Median
1321907|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for ORR by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Percentage of participants||95% Confidence Interval|Number
1321908|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for ORR by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Percentage of participants||95% Confidence Interval|Number
1321909|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in All Participants|ORR was assessed by modified RECIST 1.1 by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1321910|NCT02255097|Secondary|ORR by RECIST Version 1.1 in Human Papilloma Virus (HPV)-Positive Tumors|Participants with a HPV-positive tumor biopsy were evaluated for ORR by RECIST 1.1. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a HPV-positive tumor|||Percentage of participants||95% Confidence Interval|Number
1321911|NCT02255097|Secondary|ORR by RECIST 1.1 in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Percentage of participants||95% Confidence Interval|Number
1321912|NCT02255097|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment; up to 25 months|All participants who received at least one dose of study medication|||Participants|||Number
1321913|NCT02255097|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 months of follow-up, up to 27 months|All participants who received at least one dose of study medication|||Participants|||Number
1321914|NCT02255097|Primary|ORR by RECIST Version 1.1 in Strong Programmed Cell Death Ligand 1 (PD-L1)-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD L-1 was determined by immunohistochemistry (IHC) and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Percentage of participants||95% Confidence Interval|Number
1322018|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 2 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
1321915|NCT02255097|Primary|Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|ORR was assessed by RECIST 1.1 by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1321916|NCT02254772|Secondary|Median Time to Progression (TTP)|Tumor progression was assessed as any new lesion or increase by ≥ 50% of any previously-involved site after treatment nadir.|Up to 2 years|1 participant had stable disease, but did not provide a final follow-up at 2 years.|||Months||Full Range|Median
1321917|NCT02254772|Secondary|Tumor Response|"Tumor response was assessed per the Cheson Criteria for low-grade B-cell lymphomas.~Complete Response (CR) – No evidence disease. Partial Response (PR) – Regression of measurable disease with no new sites Progressive Disease (PD) – Any new lesion or increase by ≥ 50% of any previously-involved site after treatment nadir.~Stable Disease (SD) – Any status that is not CR; PR; or PD. See references (Cheson BD, et al. J Clin Oncol. Apr 1999;17(4):1244. PubMed ID 10561185."|Up to 2 years|Note that 1 participants initially experienced a partial response (PR), but later had progressive disease (PD).|||participants|||Number
1321918|NCT02254772|Primary|Dose-limiting Toxicity (DLT) of Ipilimumab Plus a Fixed Dose of SD-101 (1 mg/Week)|"To determine the safety and tolerability of SD-101 (1 mg/week) and local low dose radiation plus escalating doses of subcutaneously (SC)-administered ipilimumab, the incidence of dose-limiting toxicities (DLT) will be assessed according to the following DLT definitions. Related adverse events (AEs) are toxicities. “Treatment” includes radiation therapy.~Grade 4 treatment-related AE~Any drug-related AE ≥ Grade 3, including injection site reaction~≥ Grade 3 treatment-related clinical autoimmune reaction involving major organs (defined as liver, pancreas, lung, heart, kidney, bowel, bone marrow, eye, or central nervous system) which does not resolve to baseline or Grade 1 within 6 weeks~Treatment-related AE ≥ Grade 3 that persists despite adequate/maximal medical therapy and/or prophylaxis, EXCEPT~Treatment-related skin rash ≤ Grade 3, that does not require systemic steroid therapy or other immunosuppressive therapy OR~Grade 3 flu-like AEs~Uveitis ≥ Grade 2"|Up to 10 weeks|Only the starting dose level of 10 mg ipilimumab plus SD-101 (1 mg/week) was evaluated. The dose level of ipilimumab could not be escalated due to inability to obtain a higher concentration of ipilimumab.|||Dose-limiting toxicity events|||Number
1321919|NCT02254551|Secondary|Overall Response|Number of patients with confirmed Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Progressive Disease (PD) or Stable Disease (SD) according to International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=5% or less plasma cells in bone marrow, disappearance of soft tissue plasmacytoma, negative immunofixation on serum and urine. VGPR=Serum and urine M-protein detectable by immunofixation but not by electrophoresis, disappearance of any soft tissue plasmacytomas that were present at baseline. PR= at least 50% reduction from baseline in serum M-protein and at least 90% reduction from baseline in 24hr urinary M-protein. PD=Increase of 25% or more from nadir in serum or urine proteins. SD= not meeting criteria for CR, VGPR, PR or PD.|Every 3 weeks up to 48 weeks|Of 7 enrolled patients, 1 was deemed ineligible and was excluded from efficacy analyses. At a median follow-up of 6 weeks, 3 patients in Cohort 1 had progressive disease and 3 had stable disease. Study was terminated after reviewing data from this first lead-in cohort.|||Participants|||Count of Participants
1321920|NCT02254551|Primary|Time to Disease Progression|Time to progression (TTP) is measured from Day 1 of study drug administration to disease progression using International Myeloma Working Group (IMWG) Uniform Response Criteria.|every 3 weeks up to 48 weeks, then every 3 months thereafter up to 3 years from initiation of study treatment.|This outcome measure was to be assessed during the expansion phase of the study. The study closed early and did not proceed to this phase of the study. There is no data to report for this outcome measure.||||||
1321921|NCT02254551|Primary|Maximum Tolerated Dose (MTD) of LDE225 Plus Bortezomib|During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.|every 3 weeks up to 48 weeks|||||||Number
1321922|NCT02254486|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. PDR defined as the number of patients with at least one polyp in the overall colon.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321923|NCT02254486|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321924|NCT02254486|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. ADR defined as the number of patients with at least one adenoma in the overall colon.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321925|NCT02254486|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug|||Participants|||Count of Participants
1321926|NCT02254486|Primary|Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate Solution was evaluated using a non-inferiority study design.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321927|NCT02254486|Primary|Number of Patients With Successful Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
1321928|NCT02254460|Primary|Fractional Iron Absorption|Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.|Day 15|Per protocol (PP) population, defined as all participants who received at least one study treatment administration and who did not have any protocol violations deemed to affect evaluation of the iron absorption. This analysis was conducted on PP population.|||% Iron Absorbed||Standard Deviation|Mean
1321929|NCT02254421|Secondary|Percentage of All-Cause Mortality Among Participants Through Day 28||Up to Day 28|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||percentage of participants||95% Confidence Interval|Number
1321930|NCT02254421|Secondary|Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28||Up to Day 28|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||percentage of participants||95% Confidence Interval|Number
1321931|NCT02254421|Secondary|Number of Supplemental O2-Free Days Through Day 28||Up to Day 28|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||days||Inter-Quartile Range|Median
1321932|NCT02254421|Primary|Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9|The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.|Baseline to Day 9|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||log10 copies/mL||Standard Error|Mean
1321933|NCT02254408|Secondary|Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality|"Participants were considered to have an event if either condition is met:~Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or;~Participant dies prior to or on Day 28"|Up to Day 28|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1321934|NCT02254408|Primary|Percentage of Participants Who Developed a Lower Respiratory Tract Complication|"A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee:~Primary RSV lower respiratory tract infection (LRTI)~Secondary bacterial LRTI~LRTI due to unusual pathogens~Lower respiratory tract complication of unknown etiology"|Up to Day 28|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1321935|NCT02254408|Primary|Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9|The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.|Baseline; Day 9|Full Analysis Set: participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the quantitative real-time polymerase chain reaction (RT-qPCR) assay in the Day 1 nasal sample, as determined by RT-qPCR.|||log10 copies/mL||Standard Deviation|Mean
1321936|NCT02254304|Secondary|Body Mass Index (BMI)|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|Baseline, Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||Kg/m^2||Standard Deviation|Mean
1321937|NCT02254304|Secondary|Expanded Disability Status Scale (EDSS) Score|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).|Baseline, Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||Units on a scale||Standard Deviation|Mean
1321938|NCT02254304|Secondary|Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination|An AE was any untoward medical occurrence in a subject or clinical investigation in a subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to drug treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AE/ADR was planned to be reported for both the arms together.|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||subjects|||Number
1321939|NCT02254304|Secondary|Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score|The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. The scores of the MMAS-8 range from 0 to 8. This self-report scale consists of 7 items answered with a yes or no and 1 item with a 5-point Likert scale. A score below 6 indicates low adherence, a score between 6 to < 8 indicates medium adherence and a score of 8 indicates high adherence.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||subjects|||Number
1321940|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Amount of work done by subjects in spite of multiple sclerosis was presented under different percentages (0-100%)|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||Subjects|||Number
1321941|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects accomplished less work due to MS were presented.|Month 12|"Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure."|||subjects|||Number
1321942|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per day missed from work by subjects were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||hours per day||Standard Deviation|Mean
1321943|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS).|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any partial days from work due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subjects|||Number
1321944|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of full days missed from work by subjects were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days||Standard Deviation|Mean
1321964|NCT02254304|Primary|Time to the First Relapse for CIS Subjects|"A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for Rebif in CIS Subjects arm."|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||months||Inter-Quartile Range|Median
1321945|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS).|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any full days from work due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subjects|||Number
1321946|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of working days missed by relative or friend due to subjects' MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days||Standard Deviation|Mean
1321947|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects whose relatives or friends missed work due to subjects' MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subject|||Number
1321948|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per week assistant worked for subject due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||hours per day||Standard Deviation|Mean
1321949|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days per week assistant worked for subject due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days per week||Standard Deviation|Mean
1321950|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who paid someone to assist them due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subjects|||Number
1321951|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days subjects hospitalized due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days||Standard Deviation|Mean
1321952|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of times subjects visited emergency room due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants analyzed” signifies number of subjects evaluable for this outcome measure.|||emergency room visits||Standard Deviation|Mean
1321953|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits by healthcare professional to subjects' home were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||visits||Standard Deviation|Mean
1321954|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Subjects who took consultations with specialists, general practitioners for MS were presented.|Month 12|"Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects who visited to doctors for MS."|||subjects|||Number
1321955|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits to clinic by subjects due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects who visited clinic for MS.|||visits||Standard Deviation|Mean
1321956|NCT02254304|Secondary|Overall Evaluation of RebiSmart Use as Assessed by Investigator|Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||subjects|||Number
1321957|NCT02254304|Secondary|Number of Subjects With Reasons of Missed Injections|Number of subjects with the reasons of missed injections were presented. Aspartate transaminase and alanine transaminase are abbreviated as ALT and AST respectively. Glutamic oxaloacetic transaminase and glutamic pyruvic transaminase are abbreviated as GOT and GPT respectively.|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects who missed the injections are evaluable for this outcome measure.|||subjects|||Number
1321958|NCT02254304|Secondary|Mean Number of Relapses in RMS Subjects|A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||relapses||Standard Deviation|Mean
1321959|NCT02254304|Secondary|Percentage of Subjects Free From Disability Progression|Expanded Disability Status Scale is abbreviated as EDSS.|Baseline up to 12 months|Data could not be analyzed for this outcome because this EDSS progression requires EDSS to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.||||||
1321960|NCT02254304|Secondary|Percentage of Subjects Free From Clinical Disease Activity|Expanded Disability Status Scale is abbreviated as EDSS.|Baseline up to 12 months|Data could not be analyzed for this outcome because this is a composite outcome dependent on subjects free from relapses and EDSS progression, where EDSS progression requires to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.||||||
1321961|NCT02254304|Secondary|Percentage of Subjects Who Prematurely Terminated Treatment and Reasons|Percentage of subjects who prematurely terminated treatment and reasons were presented.|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||percentage of subjects|||Number
1321962|NCT02254304|Secondary|Percentage of Subjects With Relapse by Adherence Category|A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with relapses by adherence categories (<=50%, >50-75%, >75-90%, >90%) were presented. Adherence missing are the subjects who withdrew before 12 months and who did not have any relapses before withdrawal.|Month 12|"Full analysis set was used. Here Number analyzed signifies those subjects who were evaluable for specified categories. There were no subjects analyzed for certain categories (that is, “Number analyzed”= 0) because no subjects were evaluable for that arm in the specified category."|||percentage of subjects|||Number
1321963|NCT02254304|Secondary|Percentage of Subjects With Treatment Adherence|According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with treatment adherence under different categories (<=50%, >50-75%, >75-90%, >90%) were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||percentage of subjects|||Number
1321965|NCT02254304|Primary|Percentage of Relapse-free RMS Subjects|"A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for Rebif in RMS Subjects arm."|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||percentage of subjects|||Number
1321966|NCT02254252|Secondary|Side-effects|Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications|1 month|||||||
1321967|NCT02254252|Primary|Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris|One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient’s description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).|1 month||||participants|||Number
1321968|NCT02254252|Primary|Angina Episode Intensity|One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.|1 month||||units on a scale||Standard Deviation|Mean
1321969|NCT02254252|Primary|Angina Episode Frequnecy|One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.|1 month||||episodes per week||Standard Deviation|Mean
1321970|NCT02253654|Secondary|Number of RBC Units Transfused Overall and During Each Study Period|The number of red blood cell (RBC) units transfused during the study and during each study period.|Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41|Primary analysis set with available data in each study period|||participants|||Number
1321971|NCT02253654|Secondary|Weekly Epoetin Alfa Dose at Each Visit||Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35|Primary analysis set with available data at each time point|||units||Standard Deviation|Mean
1321972|NCT02253654|Secondary|Percentage of Participants With Hemoglobin Excursions at Each Visit|An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.|Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point|||percentage of participants|||Number
1321973|NCT02253654|Secondary|Hemoglobin Intra-subject Variability|Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.|The evaluation period (weeks 13 to 37)|Primary analysis set|||g/dL||Standard Deviation|Mean
1321974|NCT02253654|Secondary|Hemoglobin Rate of Change at Each Visit|Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.|Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point|||g/dL/2 weeks||Standard Deviation|Mean
1321975|NCT02253654|Secondary|Percentage of Participants With Transfusion Events Overall and During Each Study Period|The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.|Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41|Primary analysis set with available data in each study period|||percentage of participants|||Number
1321976|NCT02253654|Secondary|Hemoglobin Concentration at Each Visit||Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point|||g/dL||Standard Deviation|Mean
1321977|NCT02253654|Primary|Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period|Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.|The evaluation period (weeks 13-37)|The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.|||percentage of hemoglobin measurements||Standard Deviation|Mean
1321978|NCT02253173|Other Pre-specified|PK Substudy - Hormone Concentration Assessments (Serum Estradiol, Estrone and Estrone Conjugates; SHBG)|Blood samples will be obtained from a subset of subjects at pre-selected sites to characterize PK parameters (AUC, tmax, Cmin, Cmax, Cavg) and to measure SHBG|Pre-treatment, Day 2, Weeks 2 and 12|||||||
1321979|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Satisfaction|"Change from Baseline to Week 12 in FSFI Domain Score (Satisfaction) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
1322034|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)||within 5 minutes upon completion of procedure||||cells*10^3/µL||Standard Deviation|Mean
1321980|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Pain|"Change from Baseline to Week 12 in FSFI Domain Score (Pain) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
1321981|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Orgasm|"Change from Baseline to Week 12 in FSFI Domain Score (Orgasm) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
1321982|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Lubrication|"Change from Baseline to Week 12 in FSFI Domain Score (Lubrication) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
1321983|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Desire|"Change from Baseline to Week 12 in FSFI Domain Score (Desire) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
1321984|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Arousal|"Change from Baseline to Week 12 in FSFI Domain Score (Arousal) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
1321985|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) - Total Score|"Change from Baseline to Week 12 in FSFI Total Score as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
1321986|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 12 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3~Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321987|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 8 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3~Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321988|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 6 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3~Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321989|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 2 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain) = 3~Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321990|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 12 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline|||units on a scale||Standard Error|Least Squares Mean
1321991|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 8 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321992|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 6 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline|||units on a scale||Standard Error|Least Squares Mean
1321993|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 2 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321994|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 12 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline|||units on a scale||Standard Error|Least Squares Mean
1321995|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 8 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321996|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 6 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321997|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 2 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321998|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 12 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1321999|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 8 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 8"|Baseline to Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322000|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 6 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 6"|Baseline to Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322001|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 2 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322002|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 12 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322003|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 8 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322004|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 6 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322005|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 2 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322006|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 12 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322007|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 8 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322008|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 6 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322009|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 2 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322010|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 8 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322011|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 6 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322012|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 2 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322013|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 8 in vaginal pH as compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
1322014|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 6 in vaginal pH as compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
1322015|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 2 in vaginal pH as compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
1322016|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 8 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
1322017|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 6 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
1322035|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)||within 5 minutes upon completion of procedure||||cells*10^3/mL||Standard Deviation|Mean
1322019|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Superficial Cells|Change from Baseline to Week 8 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
1322020|NCT02253173|Secondary|Secondary Efficacy Endpoints- Vaginal Superficial Cells|Change from Baseline to Week 6 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
1322021|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Superficial Cells|• Change from Baseline to Week 2 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
1322022|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia)|"• Change from Baseline to Week 12 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1322023|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal pH|• Change from Baseline to Week 12 in vaginal pH as compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
1322024|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells|• Change from Baseline to Week 12 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
1322025|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal Superficial Cells|• Change from Baseline to Week 12 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
1322026|NCT02253160|Secondary|MNC Product Contamination/Purity - RBC Concentration (10^6/µL)||within 5 minutes upon completion of procedure||||RBC*10^6/µL||Standard Deviation|Mean
1322027|NCT02253160|Secondary|MNC Collection Efficiency (CE2%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure||||percent||Standard Deviation|Mean
1322028|NCT02253160|Other Pre-specified|Post-collection Platelet Loss in Subject|The percent change from pre-collection platelet count to post-collection subject platelet count.|24-hours after last collection procedure||||percent change||Standard Deviation|Mean
1322029|NCT02253160|Other Pre-specified|Device Deficiencies|Any time a device or disposable does not function as described in the Operator’s Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.|24-hours after last collection procedure|All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.|||events|||Number
1322030|NCT02253160|Secondary|Procedure Time (Minutes)||within 5 minutes upon completion of procedure||||minutes||Standard Deviation|Mean
1322031|NCT02253160|Secondary|Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)|A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.|within 5 minutes upon completion of procedure|Five collections also collected plasma for this sub-study.|||cells*10^3/µL||Standard Deviation|Mean
1322032|NCT02253160|Secondary|MNC Blood Product Volume (mL)|The produced unit of MNCs collected into the blood bag.|within 5 minutes upon completion of procedure||||mL||Standard Deviation|Mean
1322033|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.|||percent||Standard Deviation|Mean
1322038|NCT02253160|Secondary|MNC Collection Efficiency (CE1%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.|||percent||Standard Deviation|Mean
1322039|NCT02253160|Secondary|CD34+ Collection Efficiency (CE2 %)|Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure||||percent||Standard Deviation|Mean
1322040|NCT02253160|Primary|CD34+ Collection Efficiency (CE1 %)|The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure||||percent||Standard Deviation|Mean
1322041|NCT02253147|Secondary|Number of Subjects Receiving Re-treatment||Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow)|||Participants|||Count of Participants
1322042|NCT02253147|Secondary|Number of Subjects Receiving Touch-up Treatment||Week 2||||Participants|||Count of Participants
1322043|NCT02253147|Secondary|Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)||Week 2||||mL||Standard Deviation|Mean
1322044|NCT02253147|Secondary|Subject’s Satisfaction Score|Subjective 5-point scale with 1 being ‘very satisfied’ and 5 being ‘very dissatisfied’|Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
1322045|NCT02253147|Secondary|Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire|"The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient’s perspective.~FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').~The subject was instructed as follows: “These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:”, and provided response.~How deep your nasolabial fold are?~How your nasolabial folds look when your face is relaxed (still)?~How old your nasolabial folds make you look?~How your nasolabial folds look when you smile?~How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome."|Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
1322046|NCT02253147|Secondary|"Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale."|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse.~GAI was assessed using the baseline photograph. Subjects will be instructed: “Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale”.~Each side of the face was assessed independently."|Weeks 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
1322047|NCT02253147|Secondary|"Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)"|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of “much improved, improved, no change, worse, and much worse”.~GAI was assessed using the baseline photograph. Each side of the face was assessed independently."|Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
1322048|NCT02253147|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
1322049|NCT02253147|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
1322050|NCT02253147|Secondary|Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)|WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being ‘absent’ and 5 being ‘extreme’.|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
1331699|NCT02074059|Primary|Oxygen Saturation Levels|Oxygen saturation as determined by pulse oximetry|Within 3 Hours of Randomization|Safety Population|||percentage of oxygen saturation||Standard Deviation|Mean
1322051|NCT02253147|Secondary|Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)|WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being ‘absent’ and 5 being ‘extreme’.|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
1322052|NCT02253147|Secondary|Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®|VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain|During Injection and 5, 15, 30 minutes post-injection|VAS are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for pain assessment after touch-up treatment are based on number of patients receiving Touch-up treatment|||units on a scale||Standard Deviation|Mean
1322053|NCT02253147|Secondary|Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®|"The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).~The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and “other”.~The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate “other” if the subject experienced a sign/symptom that is not listed.~The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)"|During 14 days after initial treatment (D0) and touch-up (2 weeks)|CTR are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (RHA-UD N=32/Perl N=47)|||Participants|||Count of Participants
1322054|NCT02253147|Primary|Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.|"WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being ‘absent’ and 5 being ‘extreme’.~BLE =Blinded Live Evaluator"|Baseline and 24 weeks after last treatment||||units on a scale||95% Confidence Interval|Mean
1322055|NCT02252965|Secondary|Percentage of Subjects Who Are Compliant to Treatment|Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects|||Number
1322056|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)|Percentage of subjects with HbA1c <7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.|||percentage of subjects||95% Confidence Interval|Number
1322057|NCT02252965|Secondary|Percentage of Subjects Who Are Totally Intolerant to the Treatment|Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1322058|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7%||Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.|||percentage of subjects||95% Confidence Interval|Number
1322059|NCT02252965|Secondary|Percentage of Subjects With Marked Hyperglycemia|Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.|||percentage of subjects||95% Confidence Interval|Number
1322060|NCT02252965|Secondary|Percentage of Subjects With Hypoglycemia|Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter [mmol/L]).|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1322061|NCT02252965|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16|The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.|Baseline, Week 8 and 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
1322062|NCT02252965|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16||Baseline, Week 1, 2, 4, 8, 12,16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.|||Millimole Per Liter (mmol/L)||Standard Deviation|Mean
1322085|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 24 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1322063|NCT02252965|Secondary|Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1322064|NCT02252965|Primary|Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1322065|NCT02252965|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16||Baseline, Week 16|"Per-protocol (PP) population included all subjects who were randomly allocated to a treatment based on intent to treat and were compliant with protocol (absence of any major protocol violations). Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Percentage of HbA1c||Standard Error|Least Squares Mean
1322066|NCT02252939|Secondary|QuickDASH (Disability of the Arm, Shoulder, and Hand)||Day 1, baseline|Data were not collected||||||
1322067|NCT02252939|Secondary|Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint|Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)|Day 1, baseline|All patients with TMC Arthrosis analyzed for hyperextension of MCP joint.|||Participants|||Count of Participants
1322068|NCT02252939|Primary|Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age|Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.|Baseline at Day 1|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"|||Years||Inter-Quartile Range|Median
1322069|NCT02252744|Primary|Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease||1 day||||participants|||Number
1322070|NCT02252718|Primary|Interrater Variability (IV)|The outcome measures were interrater variability in the stool assessment by the parent and MD1 made in vivo and in the assessment by the parent in vivo and by MD2 based on the photograph(s). The IV was evaluated by calculating the proportion of exact agreement and the κ statistics for nominal data (colour) and weighted κ values for items in which there is a natural ordering of categories (consistency and amount). Correlation, based on the value of kappa (κ), was categorized as poor (κ ≤ 0.2), fair (0.21 ≤ κ ≤ 0.40), moderate (0.41 ≤ κ ≤ 0.60), good (0.61 ≤ κ ≤ 0.80) or excellent (0.81 ≤ κ ≤ 1.00).|<5min after defecation||||kappa value||95% Confidence Interval|Number
1322071|NCT02252445|Secondary|Analgesics|The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients infused with tramadol were counted.|||participants|||Number
1322072|NCT02252445|Secondary|Dizziness|Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dizziness were counted.|||participants|||Number
1322073|NCT02252445|Secondary|Blurred Vision|Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with blurred vision were counted.|||participants|||Number
1322074|NCT02252445|Secondary|Flushing|Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with flushing were counted.|||participants|||Number
1322075|NCT02252445|Secondary|Dry Mouth|Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dry mouth were counted.|||participants|||Number
1322076|NCT02252445|Secondary|Vomiting|Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with vomiting were counted.|||participants|||Number
1322077|NCT02252445|Secondary|Nausea|Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with nausea were counted.|||participants|||Number
1322078|NCT02252445|Secondary|Hemodynamic Parameters|Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.|0, 1, 5, 10 minute postoperatively||||mmHg||Standard Deviation|Mean
1322079|NCT02252445|Secondary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|0, 6 and 24 hour postoperatively|Patients with score >0 will be counted.|||participants|||Number
1322080|NCT02252445|Primary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|1 hour postoperatively|Patients with score >0 were counted.|||participants|||Number
1322081|NCT02252354|Secondary|Part 2: Clearance (CL) for [14C]-TAK-385|CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L/hr||Standard Deviation|Mean
1322082|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 72 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1322086|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 12 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1322087|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 8 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1322088|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 4 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1322089|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 2 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1322090|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 1 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
1322091|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose||Standard Deviation|Mean
1322092|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose||Standard Deviation|Mean
1322093|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of recovered radioactivity||Standard Deviation|Mean
1322094|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of recovered radioactivity||Standard Deviation|Mean
1322095|NCT02252354|Secondary|Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.|Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percent recovery of radioactivity||Standard Deviation|Mean
1322096|NCT02252354|Secondary|Part 2: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L||Standard Deviation|Mean
1322097|NCT02252354|Secondary|Part 1: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||Liter (L)||Standard Deviation|Mean
1322098|NCT02252354|Secondary|Part 2: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L/hr||Standard Deviation|Mean
1322122|NCT02252146|Primary|Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications|Frequency of adverse events, injection site reactions, and concomitant medications observed|Up to 2 years from first patient visit|Safety population|||Participants|||Count of Participants
1331700|NCT02074059|Primary|All Cause Mortality||Within 36 Weeks PMA|Safety Population|||participants|||Number
1322099|NCT02252354|Secondary|Part 1: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L/hr||Standard Deviation|Mean
1322100|NCT02252354|Primary|Part 2: Absolute Bioavailability for the Oral Tablet Formulation|Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage bioavailability||Standard Deviation|Mean
1322101|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
1322102|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
1322103|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Geometric Mean
1322104|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
1322105|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Geometric Mean
1322106|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
1322107|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng/mL||Standard Deviation|Geometric Mean
1322108|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq/mL||Standard Deviation|Geometric Mean
1322109|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
1322110|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
1322111|NCT02252354|Primary|Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).|Day 1 pre-dose and various time-points (up to Day 288) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percent recovery of radioactivity||Standard Deviation|Mean
1322112|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
1322113|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
1322114|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Geometric Mean
1322115|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
1322116|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1322117|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
1322118|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1322119|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq/mL||Standard Deviation|Geometric Mean
1322120|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
1322121|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
1323746|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|1 hour post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1322123|NCT02252133|Primary|Success Rate of Lens Centration After 7 ± 2 Days of Wear|Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as “optimal” or “slight decentration. One eye (study eye) was analyzed.|Day 7, each product|This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.|||percentage of subjects|||Number
1322124|NCT02252042|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE in Participants With PD-L1 ≥1% CPS|The number of all participants with PD-L1 ≥1% CPS who discontinued study treatment due to an AE is presented.|Up to approximately 2 years|The safety population consisted of all randomized participants with PD-L1 ≥1% CPS who received at least one dose of study treatment.|||Participants|||Count of Participants
1322125|NCT02252042|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE in All Participants|The number of all participants who discontinued study treatment due to an AE is presented.|Up to approximately 2 years|The safety population consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
1322126|NCT02252042|Secondary|Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants with PD-L1 ≥1% CPS who experienced at least one AE is presented.|Up to approximately 27 months|The safety population consisted of all randomized participants with PD-L1 ≥1% CPS who received at least one dose of study treatment.|||Participants|||Count of Participants
1322127|NCT02252042|Secondary|Number of Participants Who Experienced At Least One Adverse Event (AE) in All Participants|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented.|Up to approximately 27 months|The safety population consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
1322128|NCT02252042|Secondary|PFS Per Modified RECIST 1.1 in Participants With PD-L1 ≥1% CPS|PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1. The PFS per modified RECIST for all participants with PD-L1 ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322129|NCT02252042|Secondary|PFS Per Modified RECIST in All Participants|PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1. The PFS per modified RECIST for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322130|NCT02252042|Secondary|TTP Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The TTP per RECIST 1.1 for all participants with PD-L1 ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||Full Range|Median
1322162|NCT02251613|Primary|Mean Ocular Itching at 7 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).|Day 1, 7 minutes post-CAC|This analysis population includes all randomized participants.|||units on a scale|Participants|Standard Deviation|Mean
1322131|NCT02252042|Secondary|Time to Progression (TTP) Per RECIST 1.1 in All Participants|TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The TTP per RECIST 1.1 for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322132|NCT02252042|Secondary|DOR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. DOR assessments were based on blinded central imaging vendor review with confirmation. The DOR per RECIST 1.1 for all participants with PD-L1 ≥1% CPS who experienced a confirmed CR or PR is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS who demonstrated a confirmed CR or PR per RECIST 1.1. Participants are included in the treatment group to which they were randomized.|||Months||Full Range|Median
1322133|NCT02252042|Secondary|Duration of Response (DOR) Per RECIST 1.1 in All Participants|For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. DOR assessments were based on blinded central imaging vendor review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants who demonstrated a confirmed CR or PR per RECIST 1.1. Participants are included in the treatment group to which they were randomized.|||Months||Full Range|Median
1322134|NCT02252042|Secondary|ORR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1322135|NCT02252042|Secondary|Objective Response Rate (ORR) Per RECIST 1.1 in All Participants|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1322136|NCT02252042|Secondary|PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322137|NCT02252042|Secondary|Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322138|NCT02252042|Secondary|OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. The OS for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322139|NCT02252042|Primary|Updated Final OS for All Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The updated OS for all participants is presented. These OS results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years (Database update on 13-Oct-2017)|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322140|NCT02252042|Primary|Initial Overall Survival (OS) for All Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all participants is presented. These initial OS results are based on a data cutoff date of 15-May-2017 with a database lock date of 04-Jun-2017. At the time of the database lock of 04-Jun-2017, there was incomplete collection of survival data for 12 participants.|Up to approximately 2 years (Database lock on 04-Jun-2017)|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1322141|NCT02252016|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|24 weeks after completing study therapy (Week 36)|The FAS consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response.|||Percentage of participants||95% Confidence Interval|Number
1322142|NCT02252016|Primary|Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.|||Percentage of Participants|||Number
1322143|NCT02252016|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All-Participants-as-Treated (APaT) population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.|||Percentage of Participants|||Number
1322144|NCT02252016|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|12 weeks after completing study therapy (Week 24)|The Full Analysis Set (FAS) consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response.|||Percentage of participants||95% Confidence Interval|Number
1322145|NCT02251990|Other Pre-specified|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Study Therapy (SVR4)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in this efficacy analysis.|4 weeks after end of all therapy (Study Week 16)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in this efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
1322146|NCT02251990|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the secondary efficacy analysis.|24 weeks after end of all therapy (Study Week 36)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in the secondary efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
1322147|NCT02251990|Primary|Percentage of Participants That Discontinued From Study Therapy Due to AEs During the DB Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. A participant could discontinue from treatment but continue to participate in the study as long as consent was not withdrawn. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.|DB Treatment period (up to 12 weeks)|All randomized participants who received at least one dose of study treatment during the double-blind treatment period.|||percentage of participants|||Number
1322148|NCT02251990|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.|DB Treatment period plus first 14 follow-up days (up to 14 weeks)|All randomized participants who received at least one dose of study treatment during the double-blind treatment period.|||percentage of participants|||Number
1322149|NCT02251990|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification (LLOQ) of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the primary efficacy analysis.|12 weeks after end of all therapy (Study Week 24)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in the primary efficacy analysis.|||percentage of participants||97.5% Confidence Interval|Number
1322150|NCT02251912|Secondary|Alcohol Craving|Mean weekly Penn Alcohol Craving Scale (PACS) scores.The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from: Minimum: 0 Maximum: 30 Lower scores are associated with better outcomes.|12 weeks||||units on a scale||Standard Error|Least Squares Mean
1322151|NCT02251912|Primary|Mean Weekly Drinks Per Drinking Day|The mean number of standard drinks (the amount of alcohol in a standard drink is roughly equivalent to the amount of alcohol in a 12 ounce beer) consumed by subjects on days when they drank alcoholic beverages each week averaged over the 12-week trial.|12 weeks||||number of drinks per drinking day||Standard Error|Least Squares Mean
1322152|NCT02251912|Primary|Proportion of Heavy Drinking Days|Mean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).|12 weeks||||proportion of days per week||Standard Error|Least Squares Mean
1322153|NCT02251886|Primary|Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment|Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment|4 weeks||||participants|||Number
1322154|NCT02251717|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1322155|NCT02251717|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1322156|NCT02251717|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug|||percentage of participants|||Number
1322157|NCT02251717|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1322158|NCT02251652|Secondary|Change in Actinic Keratoses by Anatomic Site|To evaluate the number of AKs (both hypertrophic and non-hypertrophic) before therapy by anatomic site (dorsal hand) at Day 57 as compared to baseline|Baseline and Day 57|Comparisons of proportion of responders between treated and control hands|||percent change|Actinic Keratoses lesions|Standard Deviation|Mean
1322159|NCT02251652|Secondary|Change in Number of All Actinic Keratoses|To evaluate and compare the mean reduction in number of all AKs (hypertrophic and non-hypertrophic) on the dorsal hands of the combination cryotherapy- ingenol mebutate treated side vs. the cryotherapy alone side on Day 57 as compared to baseline|Baseline and Day 57|Comparisons of proportion of responders between treated and control hands|||percent change|Actinic Keratoses lesions|Standard Deviation|Mean
1322160|NCT02251652|Primary|Safety of Combination Therapy vs Cryotherapy Alone|To evaluate the safety of cryotherapy plus ingenol mebutate on dorsal hands and compare it to the safety of cryotherapy alone looking at Adverse Events.|Day 57||||Participants|||Count of Participants
1322161|NCT02251613|Secondary|Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).|Day 1, 20 minutes post-CAC|This analysis population includes all randomized participants.|||units on a scale|Participants|Standard Deviation|Mean
1322177|NCT02250443|Secondary|Pharmacokinetics (PK) Parameter of Cmax|To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins & 4 hours post-dose on Day 1.|Day 1|Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data|||ug/mL||Standard Deviation|Mean
1322163|NCT02251561|Secondary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.|||percentage of participants|||Number
1322164|NCT02251561|Primary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.|||percentage of participants|||Number
1322165|NCT02250807|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ.|Up to follow-up week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
1322166|NCT02250807|Secondary|Percentage of Participants With Viral Breakthrough|Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ.|Up to follow-up Week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
1322167|NCT02250807|Secondary|Percentage of Participants With On-Treatment Failure|Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., <LLOQ detectable or >=LLOQ.|through 12 weeks (EOT)|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
1322168|NCT02250807|Secondary|Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed.|Week 2, 3, 4, 12 and EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
1322169|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)|Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable.|At 24 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants||95% Confidence Interval|Number
1322170|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)|SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT.|4 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants||95% Confidence Interval|Number
1322171|NCT02250807|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)|SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.|12 weeks after EOT|Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants||95% Confidence Interval|Number
1322172|NCT02250703|Secondary|Presence of Amnesia to Mask Induction|Yes or No (if the patient remembers mask induction)|Day 0: at the time of discharge of the patient from the recovery room|7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part|||Participants|||Count of Participants
1322173|NCT02250703|Secondary|Wake up Behavior|"assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4~calm~not calm but easily calmed~moderately agitated or restless~combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory"|Day 0: At the end of surgery when the patient recovers from anesthesia||||Participants|||Count of Participants
1322174|NCT02250703|Secondary|Acceptance of Mask Induction|"on a scale of 1 to 4~excellent( cooperative)~good( slight fear, easily calmed)~fair ( moderate fear, not calmed with reassurance)~Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory"|Day 0: At the time when anesthesia is induced||||Participants|||Count of Participants
1322175|NCT02250703|Primary|University of Michigan Sedation Scale|"Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)~University of Michigan Sedation Scale:~0 -Awake/Alert~1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.~2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.~3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.~4 – Unarousable~Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory"|Day 0:Just before the patient will be brought to the operating room||||Participants|||Count of Participants
1322176|NCT02250443|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|The time to reach the maximum concentration after drug administration|Day 1|Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data|||hr||Full Range|Median
1322178|NCT02250443|Secondary|Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was equal or more than 2% at Week 8 and 16 were considered responders|Baseline, Day 1, 57, 113|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Percentage Change||Standard Deviation|Mean
1322179|NCT02250443|Secondary|Changes From Baseline in Muscle Function 6 Minute Walking Distance|The effect of BYM338 on additional muscle function measures (6 minute walking distance). The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.|Baseline,Day 1, 113, 169, 365, 533, 729|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Meters||Standard Deviation|Mean
1322180|NCT02250443|Secondary|Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)|The effect of BYM338 on additional muscle function measures (hand-grip and pinch-grip dynamometry).|Baseline,Day 1, 113, 169, 365, 533, 729|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Newtons||Standard Deviation|Mean
1322181|NCT02250443|Secondary|Changes From Baseline in Muscle Strength.|Quadriceps muscle strength was measured, Quadriceps Quantitative Muscle Testing (QMT) by portable fixed dynamometry (PFD). A negative change from baseline indicates deterioration|Baseline, Day 1, 113, 169, 365, 533, 729|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Newtons||Standard Deviation|Mean
1322182|NCT02250443|Secondary|Changes From Baseline in Physical Function Reported by Patients|Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. Due to the no-signal this analysis was cancelled.|Baseline, Week 104|Due to the early study termination and the small sample size in this open-label trial, this PRO analysis was cancelled.||||||
1322183|NCT02250443|Secondary|Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing|To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins & 4 hours post-dose on Day 1. Pre-dose only on each subsequent administration|Day 29, 85, 169, 253, 337, 421, 505, 589, 673, 757, 1177|Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data|||ng/mL||Standard Deviation|Mean
1322184|NCT02250443|Secondary|Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)|To assess the effect of multiple doses of BYM338 on lean body mass as measured by DXA in terms of change from baseline.|Baseline, Day 1, 57, 113, 169, 365, 533, and day 729|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data|||Percentage Change in LBM||Standard Deviation|Mean
1322185|NCT02250443|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity|Up to 29 month|safety analysis set - included all patients that received at least one dose of study drug. No statistical analysis provided for Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During this extension study|||Participants|||Number
1322186|NCT02250417|Secondary|Sleep Efficiency|Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.|measured during each of the two sleep study sessions (Study Visits 2 and 3)|Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.|||percentage of total recording time||Standard Deviation|Mean
1322187|NCT02250417|Post-Hoc|Apnea-hypopnea Index (AHI)- Modified Analysis|"AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in breathing per hour of sleep.~These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual’s sleep apnea.~This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.~The modified analysis compares the AHI within each participant where time spent in the supine position is greater than time spent in non-supine position from either the baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study."|Baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study.|Modified analysis compares the AHI when the time spent in supine position is greater than in the non-supine position either during the baseline sleep study or the non-Wave night.The baseline PSG is the clinical PSG that was the basis of the inclusion to the study performed prior to randomization.|||events/hr||Standard Deviation|Mean
1322188|NCT02250417|Secondary|Objective Sleep Quality|Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.|measured during each of the two sleep study sessions (Study Visits 2 and 3)|Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.|||mins||Standard Deviation|Mean
1322216|NCT02249585|Secondary|Mean Arterial Blood Pressure (MBP)|Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.|1, 30, 60, 90, and 120 minutes after onset of laparoscopy||||mmHg||Standard Deviation|Mean
1323747|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|30 minutes post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1322189|NCT02250417|Primary|Apnea-hypopnea Index (AHI)- Intention to Treat Analysis|"AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep.~These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual’s sleep apnea.~This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface."|measured during each of the two sleep study sessions (Study Visits 2 and 3)|The study compares the difference in AHI within each study subject with and without the use of the Wave Sleep Surface during visit 2 and 3 (intention to treat analysis).|||events/hr||Standard Deviation|Mean
1322190|NCT02250326|Secondary|Percentage of Participants With Study Drug Dose Reductions|A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.|Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 23 Dec 2017 for nab-paclitaxel and Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of investigational product.|||Percentage of Participants|||Number
1322191|NCT02250326|Secondary|Dose Intensity Per Week of Durvalumab|Dose intensity was the cumulative dose divided by the dosing period in weeks).|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who randomized or assigned and received at least 1 dose of investigational Product.|||mg/week||Standard Deviation|Mean
1322192|NCT02250326|Secondary|Dose Intensity Per Week of CC-486|Dose intensity was the cumulative dose divided by the dosing period in weeks.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who randomized or assigned and received at least 1 dose of IP.|||mg/ week||Standard Deviation|Mean
1322193|NCT02250326|Secondary|Dose Intensity Per Week of Nab-Paclitaxel|Dose intensity was the cumulative dose divided by the dosing period in weeks.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of IP.|||mg/m^2/week||Standard Deviation|Mean
1322194|NCT02250326|Secondary|Percentage of Participants Who Discontinued Study Treatment|The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|Treated population included all participants who were randomized or assigned and received at least 1 dose of study drug.|||percentage of participants|||Number
1322195|NCT02250326|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period|TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks|Safety Population included all participants who were randomized or assigned and received at least 1 dose of study drug.|||Participants|||Count of Participants
1322196|NCT02250326|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months|ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||Months||95% Confidence Interval|Median
1322197|NCT02250326|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria|Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||percentage of participants||95% Confidence Interval|Number
1322309|NCT02246998|Secondary|Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24||Baseline; Week 24|Full Analysis Set|||cells/uL||Standard Deviation|Mean
1322198|NCT02250326|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria|"Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows:~Complete Response is the disappearance of all target lesions;~Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline;~Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks."|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||Percentage of Participants||95% Confidence Interval|Number
1322199|NCT02250326|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator|Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.|From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months|Intent to Treat Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||months||95% Confidence Interval|Median
1322200|NCT02250274|Secondary|Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)||Day 7|There were too few samples collected within each group to conduct a reasonable analysis of this outcome. The samples collected are being stored for potential future use.||||||
1322201|NCT02250274|Secondary|Antibody Dependent Cellular Cytotoxicity (ADCC) Titers||Change from Baseline to 28 days|Fold change in NK cell degranulation|||Fold change||95% Confidence Interval|Geometric Mean
1322202|NCT02250274|Secondary|Polymerase Chain Reaction (PCR) Confirmed Influenza Illness||Onset >13 days after vaccination and before April 1, 2015||||participants|||Number
1322203|NCT02250274|Primary|Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza||Change from Baseline to 28 days||||Titers||95% Confidence Interval|Geometric Mean
1322204|NCT02249819|Primary|Mean Change in Picture-naming Accuracy Score|The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).|baseline, discharge|All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.|||score||Standard Deviation|Mean
1322205|NCT02249728|Secondary|Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)|area under the plasma concentration vs time curve to the last timepoint|0 to 72 hours|PK Population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1322206|NCT02249728|Secondary|Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours|Ratio of whole blood, plasma [14C] PBT2 at 24 hours|0 to 24 hours|PK population|||ratio [14C] PBT2||Geometric Coefficient of Variation|Geometric Mean
1322207|NCT02249728|Secondary|Safety and Tolerability of PBT2|As assessed by the number of participants with adverse events|72 h post oral dose|Safety Population|||participants|||Number
1322208|NCT02249728|Secondary|Oral PK Profile of PBT2 as Assessed by AUC(0-last)|Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .|72 h post oral dose||||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
1322209|NCT02249728|Secondary|IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)|Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .|0 to 72 h post oral dose|PK Population|||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
1322210|NCT02249728|Primary|Mass Balance|Amount excreted as a percentage of the administered dose (%Ae)|168 h (7 days) post dose|PK Population|||percentage of administered dose||Standard Deviation|Geometric Mean
1322211|NCT02249728|Primary|Absolute Bioavailability of PBT2 (F%)|Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).|0 to 72 hours post oral dose|PK Population|||percentage of absolute bioavailability||Standard Deviation|Mean
1322212|NCT02249585|Secondary|Surgical Rating Scale|The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.|1 min after laparoscopic procedure||||Participants|||Count of Participants
1322213|NCT02249585|Secondary|Pulmonary Compliance|Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).|1, 30, 60, 90, and 120 minutes after onset of laparoscopy||||mL/cmH2O||Standard Deviation|Mean
1322214|NCT02249585|Secondary|PaO2|PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).|1, 30, 60, 90, and 120 minutes after onset of laparoscopy||||kPa||Standard Deviation|Mean
1322215|NCT02249585|Secondary|Stroke Volume Index (SVI)|Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.|1, 30, 60, 90, 120 min after onset of laparoscopy||||mL/beat/m^2||Standard Deviation|Mean
1323748|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|prior to the initial ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1322217|NCT02249585|Primary|Cardiac Index|Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.|30 min after onset of laparoscopy||||L/min/m^2||Standard Deviation|Mean
1322218|NCT02249104|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks||||Percent change||Standard Deviation|Mean
1322219|NCT02249104|Secondary|Percent Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks||||Percent change||Standard Deviation|Mean
1322220|NCT02249104|Secondary|Mean Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks||||Lesions counted||Standard Deviation|Mean
1322221|NCT02249104|Secondary|Mean Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks||||Lesions counted||Standard Deviation|Mean
1322222|NCT02249104|Secondary|Percent Change From Baseline in Total Lesion Count||Baseline and 8 weeks||||Percent change||Standard Deviation|Mean
1322223|NCT02249104|Primary|Mean Change From Baseline in Total Lesion Count||Baseline and 8 weeks||||Lesions counted||Standard Deviation|Mean
1322224|NCT02249065|Secondary|Inflammatory Lesions|Change from baseline in facial inflammatory lesion count|14 days (Day 1 (Baseline) and Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||lesions||Standard Deviation|Mean
1322225|NCT02249065|Secondary|Facial Redness Visual Analog Scale (VAS)|The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS|14 days (Day 1 (Baseline), Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants|||Count of Participants
1322226|NCT02249065|Secondary|Subject Treatment Satisfaction Questionnaire|Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)|14 days (Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants||Standard Deviation|Mean
1322227|NCT02249065|Secondary|Subject Facial Redness Questionnaire|Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)|14 days (Day 1 (Baseline) and Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants||Standard Deviation|Mean
1322228|NCT02249065|Primary|Pre-Treatment Clinician Erythema Assessment (CEA)|The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.|14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)|Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants|||Count of Participants
1322229|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|3 month post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.|||percentage change from baseline||Standard Deviation|Mean
1322230|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|1 Month post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.|||percentage change from baseline||Standard Deviation|Mean
1322231|NCT02249052|Secondary|Subject Satisfaction|Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire|6 months|1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants|||participants satisfied|||Number
1322232|NCT02249052|Secondary|Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months|Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.|Baseline and 6 months|All study participants|||Percent change from baseline||Standard Deviation|Mean
1322233|NCT02249052|Secondary|Responder Analysis|The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline|Baseline and 6 months|All 19 participants|||participants|||Number
1322234|NCT02249052|Primary|Percent Change From Baseline in Surface Area of the Lipoma at Six Months|"The primary efficacy outcome is lipoma visible surface area defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit."|Baseline and 6 months post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.|||percentage change from baseline||Standard Deviation|Mean
1322235|NCT02248818|Other Pre-specified|EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction|EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest|8 hours after dose|Safety population|||uV2||Standard Deviation|Mean
1322236|NCT02248818|Other Pre-specified|EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest|8 hours after dose|Safety population|||uV2||Standard Deviation|Mean
1322237|NCT02248818|Other Pre-specified|EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest|8 hours after dose|Safety population|||uV2||Standard Deviation|Mean
1322238|NCT02248818|Secondary|Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD|Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 & 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]|Day 12 compared to Day 1|Pharmacokinetic population, MAD Cohorts 5 & 7|||ratio||Standard Deviation|Mean
1322239|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose|Pharmacokinetic population (subjects dosed with AZD8108)|||hours||Full Range|Median
1322240|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed|||Percent||Geometric Coefficient of Variation|Geometric Mean
1322241|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)|Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed|||Percent|Participants with urine volume data|Geometric Coefficient of Variation|Geometric Mean
1322242|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic population (subjects dosed with AZD8108)|||hours||Full Range|Median
1322243|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322244|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322245|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322246|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 & 7, Cohort 6 dod not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322247|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322248|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322249|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108|Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322250|NCT02248818|Primary|Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal|Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal|Day -1 to 7 days after last dose|Safety population|||Participants|||Number
1322251|NCT02248766|Primary|Subjective Assessments- Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)|Baseline, 1 week, 2 week, 4 week||||units on a scale||Standard Deviation|Mean
1322252|NCT02248766|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 week, 2 week, 4 week||||logMar||Standard Deviation|Mean
1322253|NCT02248727|Primary|Subjective Assessments. - Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)|Baseline, 1 Week, 2 Week, 4 Week||||units on a scale||Standard Deviation|Mean
1322254|NCT02248727|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 Week, 2 Week, 4 Week||||logMar||Standard Deviation|Mean
1322255|NCT02248675|Secondary|Insomnia Severity Index (ISI)|A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
1322256|NCT02248675|Secondary|Patient Health Questionnaire-9 (PHQ-9)|A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
1322257|NCT02248675|Secondary|Perceived Treatment Beliefs (PTS)|A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
1322258|NCT02248675|Primary|Columbia Suicide Severity Rating Scale (C-SSRS)|The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
1322259|NCT02248558|Secondary|Cost-effectiveness of Developing HIV Testing Promotional Videos|Cost-effectiveness of developing the crowdsourced video compared to the conventional video|Up to one year||||USD|||Number
1322260|NCT02248558|Secondary|Likelihood of HIV Testing|"All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be very unlikely, 1 will be unlikely, 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported."|Up to one day||||Participants|||Count of Participants
1322261|NCT02248558|Primary|First-Time HIV Testing|All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.|Up to 4 weeks following the video intervention||||Participants|||Count of Participants
1322262|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322263|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322264|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322265|NCT02248480|Secondary|Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria|A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1322266|NCT02248480|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1322310|NCT02246998|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm||Week 24|Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug.|||percentage of participants|||Number
1322267|NCT02248480|Secondary|Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322268|NCT02248480|Secondary|Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.|Baseline,Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1322269|NCT02248480|Secondary|Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322270|NCT02248480|Secondary|Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
1322271|NCT02248480|Secondary|Change From Baseline on the Patient Global Assessment Illness (PGAI) Score||Baseline, Week 14|Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced.||||||
1322272|NCT02248480|Secondary|Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322273|NCT02248480|Secondary|Percentage of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1322274|NCT02248480|Secondary|Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score|Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach’ including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
1322275|NCT02248480|Secondary|Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)|36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) − min{raw score}] / (max {raw score} − min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
1322276|NCT02248480|Secondary|Change From Baseline on the Clinical Global Impression of Severity (CGI-S)|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322277|NCT02248480|Secondary|Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)|Patient’s Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322278|NCT02248480|Primary|Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322279|NCT02248285|Primary|Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel|Describing of etiology of diarrheal illness in the study as identified by each method|Seven to ten days after enrollment||||Participants|||Count of Participants
1322280|NCT02248246|Secondary|Percentage of Participants With Hemostasis at the IMV|Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). “Yes” is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV.|Intraoperatively|Safety Set - all subjects in whom the procedure was started.|||percentage of participants||95% Confidence Interval|Number
1322281|NCT02248246|Primary|Percentage of Participants With Hemostasis at the IMA|Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). “Yes” is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA.|Intraoperatively|Safety Set - all subjects in whom the procedure was started.|||percentage of subjects||95% Confidence Interval|Number
1322282|NCT02248103|Secondary|Bone Defect Area|linear measurements collected from a digital radiography program to estimate percentage of defect fill.|Baseline and 6 months||||"mm^2"||Standard Deviation|Mean
1322283|NCT02248103|Secondary|Pocket Depth|Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months||||mm||Standard Deviation|Mean
1322284|NCT02248103|Primary|Clinical Attachment Level|Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months|defects|||mm||Standard Deviation|Mean
1322285|NCT02247960|Secondary|Number of Participants With Bacteria in Urine|Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.|3 months|10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing.|||Participants|||Count of Participants
1322286|NCT02247960|Secondary|Number of Participants Positive for Clostridium Difficile|Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).|3 months|this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)|||Participants|||Count of Participants
1322287|NCT02247960|Primary|Number of Participants With a Positive Urinary Tract Infection|After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.|12 months|this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)|||Participants|||Count of Participants
1322288|NCT02247765|Primary|SpO2 Accuracy During Motion Conditions - MaxN Sensor|For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.|up to 6 months||||Accuracy Root Mean Square|||Number
1322289|NCT02247765|Primary|SpO2 Accuracy During Motion Conditions - MaxA Sensor|For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.|up to 6 months||||Accuracy Root Mean Square|||Number
1322290|NCT02247739|Other Pre-specified|Immunogenicity|Number of participants analyzed for neutralizing C1INH-specific antibodies and neutralizing rhC1INH-specific antibodies after confirmed anti-C1INH and anti rhC1INH IgM or IgG antibodies|20 weeks|Participants analyzed for Neutralizing antibodies after confirmed testing of anti-C1INH and anti rhC1INH IgM or IgG antibodies. Count of participants displays the number of positives.|||Participants|||Count of Participants
1322333|NCT02246998|Secondary|PK Parameter: Clast for COBI|Clast is defined as the last observable concentration of drug.|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the COBI PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322291|NCT02247739|Secondary|Percentage of Participants Achieving at Least 50% Reduction in Number of Attacks|Percentage of participants achieving at least 50% reduction in the number of attacks normalized to a 28-day period as compared to the placebo treatment period|28 days|Both the rhC1INH twice weekly treatments and the rhC1INH once weekly treatment periods are compared to the placebo treatment for the safety population. One subject withdrew before receiving any treatment and is excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
1322292|NCT02247739|Secondary|Number of Participants With Adverse Events|Number of participants that experienced Treatment Emergent Adverse Events observed in safety population|20 weeks|Safety Population: All patients who received at least a partial injection of study drug. The statistical analyses are based on the actual treatment the patient received.|||Participants|||Count of Participants
1322293|NCT02247739|Primary|Number of HAE Attacks|Average number of HAE attacks normalized to a 28 day period|28 days|Intent-to-Treat (ITT) Population: All patients who were randomized into one of the treatment sequences. The statistical analyses are based on the treatments to which the patient was randomized to receive during that treatment period.|||attacks||95% Confidence Interval|Mean
1322294|NCT02247401|Secondary|Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm|Post-treatment relapse was defined as defined as confirmed HCV RNA > LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Up to 12 weeks after first dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1322295|NCT02247401|Secondary|Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm|On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.|Up to 12 or 24 weeks after first dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1322296|NCT02247401|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|Screening until 30 days after last dose|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1322297|NCT02247401|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.|12 weeks after last dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1322298|NCT02247063|Secondary|Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline|Self-reported VAS from 0 (no pain) to 10 (worst possible pain)|One month after tDCS sessions compared to baseline (6 weeks)||||participants|||Number
1322299|NCT02247063|Primary|Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline|Self-reported VAS from 0 (no pain) to 10 (worst possible pain)|Post tDCS sessions compared to baseline (one week)||||participants|||Number
1322300|NCT02247011|Primary|Serum Creatinine|Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.|5 years||||umol/l||Standard Error|Mean
1322301|NCT02247011|Primary|Serum Alkaline Phosphatase|Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.|5 years||||U/L||Standard Deviation|Mean
1322302|NCT02247011|Primary|Biochemical Markers|Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.|5 year||||mmol/L||Standard Deviation|Mean
1322303|NCT02247011|Primary|Bone Turnover Markers and 25(OH)D|C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)|5 year||||ng/ml||Inter-Quartile Range|Median
1322304|NCT02247011|Primary|Bone Mineral Density|bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)|5 year||||g/cm^2||Inter-Quartile Range|Median
1322305|NCT02247011|Primary|Vertebral Fracture Incidence|Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)|5 year||||participants|||Number
1322306|NCT02247011|Primary|Non-vertebral Fracture Incidence|Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).|5 year|In 1100 participants, 975 of them finished the questionnaire|||participants|||Number
1322307|NCT02246998|Secondary|Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities|Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.|Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)|Safety Analysis Set|||Percentage of participants|||Number
1322308|NCT02246998|Secondary|Percentage of Participants Experiencing Adverse Events (AEs)|Incidences of adverse events and laboratory abnormalities will be summarized.|Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)|Safety Analysis Set|||Percentage of participants|||Number
1322311|NCT02246998|Secondary|PK Parameter: AUCinf for Iohexol|AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” on Day 1 and Weeks 4, 8, 16, and 24|Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed.|||h*µg/mL||Standard Deviation|Mean
1322312|NCT02246998|Secondary|PK Parameter: t1/2 for TFV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the TFV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322313|NCT02246998|Secondary|PK Parameter: AUCtau for TFV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the TFV PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1322314|NCT02246998|Secondary|PK Parameter: λz for TFV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the TFV PK Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
1322315|NCT02246998|Secondary|PK Parameter: Ctau for TFV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the TFV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322316|NCT02246998|Secondary|PK Parameter: Tlast for TFV|Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322317|NCT02246998|Secondary|PK Parameter: Clast for TFV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the TFV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322318|NCT02246998|Secondary|PK Parameter: Tmax for TFV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the TFV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322319|NCT02246998|Secondary|PK Parameter: Cmax for TFV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322320|NCT02246998|Secondary|PK Parameter: t1/2 for RTV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the RTV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322321|NCT02246998|Secondary|PK Parameter: λz for RTV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the RTV PK Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
1322322|NCT02246998|Secondary|PK Parameter: AUCtau for RTV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the RTV PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1322323|NCT02246998|Secondary|PK Parameter: Ctau for RTV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the RTV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322324|NCT02246998|Secondary|PK Parameter: Tlast for RTV|Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322325|NCT02246998|Secondary|PK Parameter: Clast for RTV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the RTV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322326|NCT02246998|Secondary|PK Parameter: Tmax for RTV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the RTV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322327|NCT02246998|Secondary|PK Parameter: Cmax for RTV||Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322328|NCT02246998|Secondary|PK Parameter: t1/2 for COBI|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the COBI PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322329|NCT02246998|Secondary|PK Parameter: AUCtau for COBI|AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the COBI PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1322330|NCT02246998|Secondary|PK Parameter: λz for COBI|λz is defined as the terminal elimination rate constant.|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the COBI PK Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
1322331|NCT02246998|Secondary|PK Parameter: Ctau for COBI|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the COBI PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322332|NCT02246998|Secondary|PK Parameter: Tlast for COBI|"Tlast is defined as the time of Clast.~Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation."|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322352|NCT02246673|Secondary|Incidence of Treatment-Emergent Adverse Events||10 weeks||||Number of participants|||Number
1322334|NCT02246998|Secondary|PK Parameter: Tmax for COBI|Tmax is defined as the time of Cmax.|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the COBI PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1322335|NCT02246998|Secondary|Pharmacokinetic (PK) Parameter: Cmax for COBI|Cmax is defined as the maximum observed concentration of drug in plasma.|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post “time zero” at Weeks 4, 8, 16, and 24|Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1322336|NCT02246998|Secondary|Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
1322337|NCT02246998|Secondary|Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
1322338|NCT02246998|Secondary|Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
1322339|NCT02246998|Secondary|Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
1322340|NCT02246998|Secondary|Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)||Up to 24 weeks plus 30 days|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
1322341|NCT02246998|Secondary|Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)||Up to 24 weeks plus 30 days|Safety Analysis Set|||Participants|||Count of Participants
1322342|NCT02246998|Primary|Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24|MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL|Week 24|Participants in the PD Analysis Set with available data were analyzed.|||mL/min/1.73m^2||Standard Deviation|Mean
1322343|NCT02246998|Primary|Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24|GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL|Week 24|Participants in the PD Analysis Set with available data were analyzed.|||mL/min||Standard Deviation|Mean
1322344|NCT02246998|Primary|Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24||Week 24|Participants in the pharmacodynamics (PD) analysis Set (all treated participants in each group, who have evaluable baseline and at least 1 postbaseline aGFR and /or eGFR at any visit) with available data were analyzed.|||mL/min||Standard Deviation|Mean
1322345|NCT02246777|Primary|Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.|Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||percentage of eyes|Eyes||Number
1322346|NCT02246777|Primary|Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.|Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat Analysis Set with non-missing data|||percentage of eyes|Eyes||Number
1322347|NCT02246777|Primary|Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||percentage of eyes|Eyes||Number
1322348|NCT02246777|Primary|Percent Change From Baseline in IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.|Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||percent change|Eyes|Standard Deviation|Mean
1322349|NCT02246777|Primary|Change From Baseline in IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.|Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||mmHG|Eyes|Standard Deviation|Mean
1322350|NCT02246777|Primary|Mean Intraocular Pressure (IOP)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||mmHG|Eyes|Standard Deviation|Mean
1322351|NCT02246764|Primary|Extent of Exposure|Exposure to study medication in days for all treatment groups|12 months|Safety Population|||days||Standard Deviation|Mean
1322354|NCT02246673|Secondary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1322355|NCT02246673|Secondary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||ng·hr/mL||95% Confidence Interval|Geometric Mean
1322356|NCT02246673|Secondary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||hr||Full Range|Median
1322357|NCT02246673|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||ng/mL||95% Confidence Interval|Geometric Mean
1322358|NCT02246673|Primary|Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)|Percentage (%) change from baseline in fractional excretion of uric acid.|28 days||||Percentage (%)||Standard Error|Mean
1322359|NCT02246673|Primary|Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)|Percentage (%) change from baseline in renal clearance of uric acid.|28 days||||Percentage (%)||Standard Error|Mean
1322360|NCT02246673|Primary|Urine Uric Acid % Change (0-24h) (Aeur, CB)|Percentage (%) change from baseline in the amount of uric acid recovered in urine.|28 days||||Percentage (%)||Standard Error|Mean
1322361|NCT02246673|Primary|Serum Urate Maximum Percentage (%) Change (Emax, CB)|Maximum observed percentage (%) change from baseline in serum urate concentrations.|28 days||||Percentage (%)||Standard Error|Mean
1322362|NCT02246660|Primary|6-Minute Walk Distance, Meters|Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.|Baseline and 6 month follow-up||||meters||Standard Deviation|Mean
1322363|NCT02246621|Secondary|PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20||Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose|All randomized participants who received at least one dose of study drug with evaluable PK data.|||liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1322364|NCT02246621|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20||Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose|All randomized participants who received at least one dose of study drug with evaluable PK data.|||nanogram*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1322365|NCT02246621|Secondary|Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale|"The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).~Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients, per Pickard et al (2007)."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
1322366|NCT02246621|Secondary|Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L)|"The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.~Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients, per Pickard et al (2007)."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
1322367|NCT02246621|Secondary|Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire|"The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, Not at all; 2, A little; 3, Quite a bit; to 4, Very much . All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
1322375|NCT02246621|Primary|Progression Free Survival (PFS)|PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Months||95% Confidence Interval|Median
1322368|NCT02246621|Secondary|Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores|"EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Symptom scale ranges from: 1, Not at all; 2, A little; 3, Quite a bit; to 4, Very much. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.~EORTC change score definitions are described in Cocks et al, (2012) and differ according to each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline"|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
1322369|NCT02246621|Secondary|Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores|"EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Functional scale options are defined on a 7-point scale ranging from 1, Very poor to 7, Excellent. A linear transformation is applied to standardize the raw scores to range between 0 and 100. For functional domains and global health status, higher scores represent a better level of functioning. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate. EORTC change score definitions are described in Cocks et al, (2012) and differ for each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
1322370|NCT02246621|Secondary|Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])|CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) * 100.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
1322371|NCT02246621|Secondary|Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])|DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
1322372|NCT02246621|Secondary|Duration of Response (DoR)|DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.|CR or PR to Disease Progression or Death Due to Any Cause (Up to 26 Months)|All randomized participants who received at least one dose of study drug and first evidence of CR or PR as assessed by the investigator.|||Months||95% Confidence Interval|Median
1322373|NCT02246621|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
1322374|NCT02246621|Secondary|Overall Survival (OS)|OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)||2021-12-31|12/2021||||
1322376|NCT02246608|Secondary|Growth Factors|Fluid collected from the wound will be examined for the presence of growth factors and interleukins.|12 weeks|Data ended up not being collected for subjects and analysis was not completed for this outcome. Only have data on wound healing from wound measurements.||||||
1322378|NCT02246582|Secondary|Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)|Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.|||percentage||Standard Deviation|Mean
1322379|NCT02246582|Secondary|Retrospective Re-Analysis (MARD With 1 Additional Calibration)|Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.|||percentage||Standard Deviation|Mean
1322380|NCT02246582|Primary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)|Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.|||percentage||Standard Deviation|Mean
1322381|NCT02246309|Other Pre-specified|Clinical Pregnancy Rate|Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer|4 weeks||||Participants|||Count of Participants
1322382|NCT02246309|Secondary|Embryo Quality|Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)|Three Days||||Embryos||Standard Error|Mean
1322383|NCT02246309|Primary|Personnel Effort|Number of minutes spent by laboratory personnel technical staff in support of each system|Three days||||technical staff minutes spent per embryo|embryos|Standard Error|Mean
1322384|NCT02246166|Secondary|Body Temperature Reduction|Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||°C (degree Celsius)||Standard Error|Least Squares Mean
1322385|NCT02246166|Secondary|Cough Severity Assessment|Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322386|NCT02246166|Secondary|Sneezing Severity Assessment|Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322387|NCT02246166|Secondary|Runny Nose Severity Assessment|Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322388|NCT02246166|Secondary|Nasal Congestion Severity Assessment|Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1324765|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)|12 hours|Safety Population|||μg/L||Standard Deviation|Mean
1322389|NCT02246166|Secondary|Extremities Pain Severity Assessment|Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322390|NCT02246166|Secondary|Headache Severity Assessment|Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322391|NCT02246166|Secondary|Sore Throat Severity Assessment|Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322392|NCT02246166|Secondary|Global Assessment of Treatment|After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: “How well did the test medication control your symptoms?” (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Participants|||Number
1322393|NCT02246166|Primary|Symptom Severity Assessment at 4 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use."|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322394|NCT02246166|Primary|Symptom Severity Assessment at 3 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use."|3 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322395|NCT02246166|Primary|Symptom Severity Assessment at 2 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use."|2 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322396|NCT02246166|Primary|Symptom Severity Assessment at 1 Hour|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use."|1 hour|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322444|NCT02243202|Secondary|Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26|Percentage of participants with weight loss >= 5 percent were analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1322397|NCT02246166|Primary|Symptom Severity Assessment at 30 Minutes|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use."|30 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322398|NCT02246166|Primary|Symptom Severity Assessment at 15 Minutes|"Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use."|15 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1322399|NCT02246114|Primary|Primary Outcome of Serum Cotinine Levels|The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.|1 year|Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.||||||
1322400|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before induction of anesthesia||||units on a scale m-YPAS||Standard Deviation|Mean
1322401|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before entering operation room||||units on a scale m-YPAS||Standard Deviation|Mean
1322402|NCT02246062|Primary|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (< 30).|24 hours before surgery||||units on a scale m-YPAS||Standard Deviation|Mean
1322403|NCT02245412|Secondary|To Evaluate the Pharmacokinetic (PK) Parameters of IV ALXN1007|AUC|Treatment Period (8 weeks) and Follow-up Period (180days).|Due to early termination of the study and the clinical development of ALXN1007 program, a number of pre-specified PK analyses were not completed. As a result, pharmacokinetic final evaluations of ALXN1007 for the cohorts 20 mg/kg of ALXN1007 once weekly and 20 mg/kg of ALXN1007 twice weekly are not available.|||h*ug/mL||Full Range|Median
1322404|NCT02245412|Secondary|To Evaluate the Pharmacokinetic (PK) Parameters of IV ALXN1007|Cmax|Treatment Period (8 weeks) and Follow-up Period (180days).|Due to early termination of the study and the clinical development of ALXN1007 program, a number of pre-specified PK analyses were not completed. As a result, pharmacokinetic final evaluations of ALXN1007 for the cohorts 20 mg/kg of ALXN1007 once weekly and 20 mg/kg of ALXN1007 twice weekly are not available.|||ug/mL||Full Range|Median
1322405|NCT02245412|Secondary|To Evaluate the Pharmacokinetic (PK) Parameters of IV ALXN1007|Tmax|Treatment Period (8 weeks) and Follow-up Period (180days).|Due to early termination of the study and the clinical development of ALXN1007 program, a number of pre-specified PK analyses were not completed. As a result, pharmacokinetic final evaluations of ALXN1007 for the cohorts 20 mg/kg of ALXN1007 once weekly and 20 mg/kg of ALXN1007 twice weekly are not available.|||hours||Full Range|Median
1322406|NCT02245412|Primary|Overall Acute GVHD Response Rate at Day 28|Percentage of subjects with overall acute GVHD response|day 28|One of the patients in the 10 mg/kg once weekly group was prematurely discontinued from the Treatment Period after receiving a single infusion of ALXN1007 due to lack of confirmed GI GVHD by biopsy.|||Participants|||Count of Participants
1322407|NCT02245360|Secondary|Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment|measurement of IgE in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.|||UA/ml||Standard Deviation|Mean
1322408|NCT02245360|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum|measurement of IgG4 in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.|||mgA/L||Standard Deviation|Mean
1322409|NCT02245217|Primary|RECIST 1.1 Therapeutic Responses to 1 Cycle|The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a >30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion|1 month||||participant responses based on RECIST1.1|||Number
1322680|NCT02238925|Primary|Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)|Time-matched QTcF Changes From Baseline after the start of first infusion|21 days|All subjects who received any dose of study drug and had at least 1 time-matched change from baseline in ECG parameters.|||msecs||Standard Deviation|Mean
1322410|NCT02245217|Primary|FLT Therapeutic Responses to 1 Cycle|The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.|1 month|Patients who completed both baseline and follow-up imaging. A synthesis failure for FLT occurred on the follow-up imaging for one patient, so that patient was excluded from the FLT analysis.|||participant responses based on EORTC|||Number
1322411|NCT02245217|Primary|FDG Therapeutic Responses to 1 Cycle|The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.|1 month||||participant responses based on EORTC|||Number
1322412|NCT02244944|Secondary|Reduction in Hepatic Fat Fraction|Determine if Ezetimibe-Ursodiol combination therapy reduces total fat in the liver as assessed by MRI|6 months|The trial was terminated early. No data was collected to analyze the primary outcome measure.||||||
1322413|NCT02244944|Secondary|Increase in Plasma Lathosterol|Determine if Ezetimibe-Ursodiol combination therapy promotes a net-negative sterol balance as evidenced by an increase in the cholesterol synthesis intermediate, lathosterol, in plasma.|6 months|The trial was terminated early. No data was collected to analyze the secondary outcome measure.||||||
1322414|NCT02244944|Primary|Reduction in Serum Alanine Transaminase (ALT)|Determine if Ezetimibe-Ursodiol combination therapy improves liver function tests (ALT)|6 months|The trial was terminated early. No data was collected to analyze the primary outcome measure.||||||
1322415|NCT02244840|Secondary|Convenience|Questionnaires|3 minute|||||||
1322416|NCT02244840|Primary|Anal Resting Pressure Change|before and after bidet/sitz bath for 3 minute|3 minute||||mmHg||Standard Deviation|Mean
1322417|NCT02244619|Post-Hoc|Hospital Length of Stay (LOS)|Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.|Pre-op admission to hospital discharge||||Hours||Inter-Quartile Range|Median
1322418|NCT02244619|Post-Hoc|Post-Anesthesia Care Unit (PACU) Length of Stay, Hours|PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.|PACU admission time until PACU discharge time||||Hours||Inter-Quartile Range|Median
1322419|NCT02244619|Other Pre-specified|Time to First Rescue Opioid (PRN Order)||During post-op period up to 24 hrs after surgery||||Minutes||Inter-Quartile Range|Median
1322420|NCT02244619|Other Pre-specified|Time to First Ambulation - 10 Feet||During post-op period up to 24 hours after surgery||||Hours||Inter-Quartile Range|Median
1322421|NCT02244619|Other Pre-specified|Post-operative Nausea and Vomiting||During post-op period up to 24 hrs after surgery||||Participants|||Count of Participants
1322422|NCT02244619|Secondary|Patient-rated Pain in the Post-operative Period|Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.|Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery||||Visual analog pain scale (0-10)||Inter-Quartile Range|Median
1322423|NCT02244619|Primary|Total Post-operative Use of Opioids|Post-operative use of opioids, measured in morphine milligram equivalent (MME) units|During post-op period up to 24 hrs after surgery||||Morphine milligram equivalents (MME)||Inter-Quartile Range|Median
1322424|NCT02244580|Secondary|Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS|Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS|5 years||||Hazard ratio||95% Confidence Interval|Number
1322425|NCT02244580|Secondary|Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)|High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)|5 years||||Hazard ratio||95% Confidence Interval|Number
1322426|NCT02244580|Primary|5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™|Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))|5 year from the date of patient randomisation||||percentage of analyzed participants|||Number
1322427|NCT02243943|Secondary|Sedation|using the Leiden observer alertness score (1 alert - 5 sedated)|45 minutes post surgery||||sedation scale (1 alert - 5 sedated)||95% Confidence Interval|Mean
1322428|NCT02243943|Secondary|Pain|using the 1-10 numeric rating scale|45 minutes post surgery||||Numeric rating scale. 1(low)-10(maximum)||95% Confidence Interval|Mean
1322429|NCT02243943|Primary|Mean Lowest Saturation|Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery|45 minutes post surgery||||percentage of oxygen saturation||95% Confidence Interval|Mean
1322430|NCT02243293|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1322445|NCT02243202|Primary|Percent Change From Baseline in Body Weight at Week 26|The percent change from baseline in body weight at Week 26 was analysed.|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Percent Change||Standard Error|Least Squares Mean
1322431|NCT02243293|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population) with evaluable data.|||percentage of participants||95% Confidence Interval|Number
1322432|NCT02243293|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)|SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1322433|NCT02243293|Primary|Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1322434|NCT02243293|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
1322435|NCT02243280|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit|||percentage of participants||95% Confidence Interval|Number
1322436|NCT02243280|Secondary|Percentage of Participants With On-treatment Virologic Failure|The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment|Intention-to-treat population: all participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1322437|NCT02243280|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|Intention-to-treat population: all participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1322438|NCT02243280|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intention-to-treat population: all participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1322439|NCT02243202|Other Pre-specified|Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26|Percentage of participants with weight loss >= 10 percent at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.|||Percentage of Participants|||Number
1322440|NCT02243202|Other Pre-specified|Change From Baseline in Pulse Rate at Week 26|Change from baseline in pulse rate at week 26|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Beats Per Minute (Beats/Min)||Standard Error|Least Squares Mean
1322441|NCT02243202|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Change from baseline in diastolic blood pressure (DBP) at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1322442|NCT02243202|Secondary|Absolute Change From Baseline in Body Weight at Week 26|Absolute change from baseline in body weight was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Kilogram (Kg)||Standard Error|Least Squares Mean
1322443|NCT02243202|Secondary|Change From Baseline in Systolic Blood Pressure at Week 26|Change from baseline in systolic blood pressure was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1325416|NCT02182895|Secondary|Percentage of Blood Glucose Readings in 70-140 mg/dL Range|Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.|Days 2 to 5|completed subjects|||% of blood glucose readings|||Number
1322446|NCT02243176|Secondary|Change From Baseline in Body Weight|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||kg||Standard Error|Least Squares Mean
1322447|NCT02243176|Secondary|Change From Baseline in HOMA-β|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||mU/mmol||Standard Error|Least Squares Mean
1322448|NCT02243176|Secondary|Change From Baseline in 2H Postprandial Glucose (2HPPG)|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||mmol/l||Standard Error|Least Squares Mean
1322449|NCT02243176|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||mmol/l||Standard Error|Least Squares Mean
1322450|NCT02243176|Secondary|Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events|Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c<7.0% without GI adverse events.|Whole study duration|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||percentage of participants|||Number
1322451|NCT02243176|Secondary|Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%|Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c<7.0%|24 weeks|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||percentage of participants|||Number
1322452|NCT02243176|Secondary|Proportion (%) of Patients With Any GI Adverse Events|Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.|24 weeks|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||percentage of participants|||Number
1322453|NCT02243176|Primary|Absolute Change From Baseline in HbA1c at Week 24 (DAO)|The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.|From baseline to 24 week|The Per Protocol analysis set was a subset of the Full analysis set that included subjects who did not have significant protocol deviations that affect the study outcome. The exclusions from the PP analysis set was determined prior to database lock.|||% (HbA1c)||Standard Error|Least Squares Mean
1322454|NCT02243176|Primary|Absolute Change From Baseline in HbA1c at Week 24 (DAO)|Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||% (HbA1c)||Standard Error|Least Squares Mean
1322455|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months (from Baseline)||||units on a scale||Standard Deviation|Mean
1322456|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months (from Baseline)||||units on a scale||Standard Deviation|Mean
1322457|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
1322458|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months (from Baseline)||||units on a scale||Standard Deviation|Mean
1322459|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months (from Baseline)||||units on a scale||Standard Deviation|Mean
1342649|NCT01911065|Primary|Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV||Day 0 to Day 35||||Participants|||Count of Participants
1322460|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
1322461|NCT02243007|Secondary|Local Control Rate|The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated||||||
1322462|NCT02243007|Secondary|Rate of Pathologic Downstaging|The number of participants achieving a reduction in the pathological staging of the primary cancer.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated||||||
1322463|NCT02243007|Secondary|Correlation of Biomarkers With PFS|Analysis of the correlation between selected bio-markers and progression free survival.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated||||||
1322464|NCT02243007|Secondary|30-day Post-operative Mortality Rate|Number of patients who died following surgery.|30 Days|Study ended prematurely, no results available||||||
1322465|NCT02243007|Secondary|Surgical Morbidity Rate|Number of patients experiencing a specific surgery related morbidity|within 30 days of surgery|Study ended prematurely, no results available||||||
1322466|NCT02243007|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days|Baseline, 28 Days||||participants|||Number
1322467|NCT02243007|Secondary|Overall Survival Rate|Overall survival rate at five years using Kaplan-Meier survival analysis|Baseline, 5 Years|Study terminated before endpoint was reached, no data available||||||
1322468|NCT02243007|Secondary|Pathologic Complete Response Rate (pCR).|Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.|18 Months|No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response.||||||
1322469|NCT02243007|Primary|Survival Rate at 18 Month|Number of participants surviving after 18 months of study follow-up|18 Month||||Participants|||Count of Participants
1322470|NCT02242994|Secondary|Error Rate of Communication|Amount of typing errors per sentence|At time of experiment||||errors||Standard Deviation|Mean
1322471|NCT02242994|Primary|Speed of Communication|Measure time (in minutes) to type 3 pre-set sentences|Immediately||||minutes||Standard Error|Mean
1322472|NCT02242643|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
1322473|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
1322474|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
1322475|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
1322476|NCT02242643|Secondary|Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.|"Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature < 38.0°C but with missing values for at least one day during the solicited period.~Grade 3 fever was defined as temperature greater than (>) 39.0°C."|During a 2-day (Days 0-1) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
1322477|NCT02242643|Secondary|Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) follow-up period after each vaccination.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Days||Full Range|Median
1322478|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
1322479|NCT02242643|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting ‘Yes’ for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day (Day 0 – Day 6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
1322480|NCT02242643|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1322481|NCT02242643|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1322482|NCT02242643|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1322483|NCT02242643|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Mean
1322508|NCT02241889|Secondary|Percent of Time of CBG>180 mg/dl|Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percentage of time||95% Confidence Interval|Mean
1322585|NCT02239692|Secondary|Ascending Colon Cleansing Responder Status (ITT)|Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.|||percentage of subjects|||Number
1322484|NCT02242643|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1322485|NCT02242643|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains|"Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria)."|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1322486|NCT02242630|Other Pre-specified|Safety|Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.|6 weeks|||||||
1322487|NCT02242630|Secondary|Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale|Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.|6 weeks||||units on a scale||95% Confidence Interval|Mean
1322488|NCT02242630|Primary|Change in Shoulder Function, as Measured by the QuickDASH ®|The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)|6 weeks||||units on a scale||95% Confidence Interval|Mean
1322489|NCT02242305|Secondary|Percentage of Event for Time to Therapeutic Effect|This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.|From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.|||Percentage of event|||Number
1322490|NCT02242305|Secondary|Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination|Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).|Up to 3 days.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.|||Participants|||Number
1322491|NCT02242305|Secondary|Global Assessment of Tolerability by Investigator on a 4-point Scale|The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).|Day 3.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.|||Participants|||Number
1322492|NCT02242305|Secondary|Number of Patients With Adverse Events|The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.|Up to 3 days.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.|||Participants|||Number
1322493|NCT02242305|Secondary|Global Assessment of Efficacy by Patient on 4-point Scale|The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).|Post 3 days of treatment.|Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.|||Participants|||Number
1322494|NCT02242305|Secondary|Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)|The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 – 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: “How many times have the spasm-like pains occurred today?” 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.|Up to 3 days.|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.|||Units on a scale||Standard Deviation|Mean
1322652|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 24|Analysis population consisted of observed data only.|||Participants|||Count of Participants
1322495|NCT02242305|Primary|Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA|"The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from no pain to the most severe pain imaginable)."|3 days (1 day)|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.|||Units on a scale|||Number
1322496|NCT02242201|Other Pre-specified|Number of Participants Reporting a NRS Pain Score Greater Than 3|Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.|3 month follow up|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||Participants|||Count of Participants
1322497|NCT02242201|Other Pre-specified|Number of Participants Reporting Complications Since Surgery|Complications were collected by telephone interview after surgery.|Post-operative Day 1 Through 3 - Month Follow-up|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||Participants|||Count of Participants
1322498|NCT02242201|Other Pre-specified|Change in Short Form-36 (SF-36) Quality of Life Mental Component|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 3 months|Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||units on a scale||Standard Deviation|Mean
1322499|NCT02242201|Other Pre-specified|Change in Short Form-36 (SF-36) Quality of Life Physical Component|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 3 months|Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||units on a scale||Standard Deviation|Mean
1322500|NCT02242201|Other Pre-specified|Post-Operative Pain Score|Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.|3 month follow-up|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||units on a scale||Inter-Quartile Range|Median
1322501|NCT02242201|Other Pre-specified|Change in Unipedal Stance Time|Length of time in seconds a patient could stand on involved leg|Baseline, 3 months|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||seconds||Inter-Quartile Range|Median
1322502|NCT02242201|Other Pre-specified|Hospital Length of Stay|Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.|Post-operative Day 1 through discharge (approximately 3 days)||||days||Inter-Quartile Range|Median
1322503|NCT02242201|Secondary|Total Opioid Consumption During Hospitalization|Measured in daily oral morphine equivalents (OME)|Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2|For Post Operative Day (POD) 2, data were missing for 26 subjects (7 in the PNB group, 9 in the PAI-R group, and 10 in the PAI-L group).|||Oral morphine equivalent in milligrams||Inter-Quartile Range|Median
1322504|NCT02242201|Primary|Maximum Postoperative Pain Score|Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.|Post-Operative Day 1 (0600-1200)||||units on a scale||Inter-Quartile Range|Median
1322505|NCT02242019|Primary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 36 Weeks|Some subjects had multiple toenails with onychomycosis disease involvement that were treated and analyzed, resulting in a total of 139 study toenails being analyzed.|||millimeters (mm)|Participants|Standard Deviation|Mean
1322506|NCT02242019|Secondary|Change in Percent (%) of Onychomycosis Disease Involvement|The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.|Baseline and 36 Weeks||||percentage of disease involvement|Participants|Standard Deviation|Mean
1322507|NCT02242019|Primary|Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|Baseline and 36 Weeks||||toenails|Participants||Number
1322653|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 12|Analysis population consisted of observed data; ie. subjects with data at Week 12.|||Participants|||Count of Participants
1322509|NCT02241889|Secondary|Number of Events With CBG <50 mg/dl|Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||occurrences of blood glucose < 50 mg/dl|||Number
1322510|NCT02241889|Secondary|Number of Events With CBG Between 70 – 180 mg/dl|Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||# of events||95% Confidence Interval|Mean
1322511|NCT02241889|Secondary|Number of Events Capillary Blood Glucose (CBG) <70 mg/dl|Number of events measured with capillary blood glucose <70 mg/dl.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||occurrences of blood glucose < 70 mg/dl||95% Confidence Interval|Mean
1322512|NCT02241889|Secondary|Percent of Time With Sensed Glucose > 180 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percent of time||95% Confidence Interval|Mean
1322513|NCT02241889|Secondary|Percent of Time With Sensed Glucose < 50 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percent of time||95% Confidence Interval|Mean
1322514|NCT02241889|Secondary|Number of Carbohydrate Treatments|Assess the number of rescue carbohydrate treatments.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||carbohydrate treatments||95% Confidence Interval|Mean
1322515|NCT02241889|Secondary|Mean of the Mean Sensed Glucose Per Participant|Assess the mean sensed glucose per participant using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||mg/dl||95% Confidence Interval|Mean
1322516|NCT02241889|Primary|Percent of Time With Sensed Glucose Between 70-180 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads.|from start of exercise (~hour 12) until study completion (hour 21)|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percent of time||95% Confidence Interval|Mean
1322517|NCT02241889|Primary|Percent of Time With Sensed Glucose < 70 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.|from start of exercise (~hour 12) until study completion (hour 21)|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percentage of time||95% Confidence Interval|Mean
1322518|NCT02241785|Secondary|Change in MSIS-29 Physical Impact Scores From Baseline (Day -1) to Reset Baseline (Week 8)|The MSIS-29 is a brief self-administered MS-specific instrument measuring physical (20 items) and mental/psychological (9 items) impact of MS. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.|Baseline (Day -1) to Reset Baseline (Week 8)|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.|||units on a scale||Standard Deviation|Mean
1322519|NCT02241785|Secondary|Pre- and Post-Natalizumab Infusion Annualized Relapse Rate (ARR) Comparison at Month 12|An MS relapse was defined as the onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by new objective abnormalities on a neurological examination, and not explained solely by non-MS processes such as fever, infection, severe stress, or drug toxicity. 95% confidence interval is based on a Poisson regression model.|From 12 months prior to natalizumab infusion and 12 months post-natalizumab infusion|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.|||relapses per subject-year||95% Confidence Interval|Number
1322520|NCT02241785|Secondary|Proportion of Participants With NEDA From Week 8 (Reset Baseline) to Week 104|Proportion of participants with NEDA from Week 8 (Reset Baseline) to Week 104 (with no 12-week confirmed EDSS progression determined at Week 116). NEDA was defined as follows: no EDSS progression (12-week sustained); no relapses; no Gd+ lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of CUA lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.|from Week 8 (Reset Baseline) to Week 104|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1322521|NCT02241785|Secondary|Change in T1 Unenhancing Lesion Volume and T2 Lesion Volume From Baseline (Day -1) to Reset Baseline (Week 8)|As measured by magnetic resonance imaging.|Baseline (Day -1) to Reset Baseline (Week 8)|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.|||cc||Standard Deviation|Mean
1322558|NCT02240030|Secondary|PD Patient Diary|Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.|post week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||hours||95% Confidence Interval|Least Squares Mean
1322522|NCT02241785|Primary|Proportion of Participants With No Evidence of Disease Activity (NEDA) From Reset Baseline (Week 8) to Week 56|The proportion of participants with NEDA, defined as follows: no Expanded Disability Status Scale (EDSS) progression (12-week sustained); no relapses; no gadolinium enhancing (Gd+) lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of combined unique active (CUA) lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.|Reset Baseline (Week 8) to Week 56|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
1322523|NCT02241720|Primary|Number of Participants With Stable Disease at Eight Weeks Post-Treatment|Patients had disease assessed by CT scans. Stable Disease is defined by any response better than Progression as defined by RECIST 1.1. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 months - 3 months treatment and 8 weeks post end of treatment visit|3 subjects did not complete an 8 week EOT visit for: Death, Patient W/D, AE.|||Participants|||Count of Participants
1322524|NCT02241551|Secondary|Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT|This will be measured using the FACT-HB questionaire|Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
1322525|NCT02241551|Secondary|Radiological Response Rate to Therapy|Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy|Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
1322526|NCT02241551|Secondary|Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues|This wil be measured in tissues that are obtained at screening and in the resected tumour specimen|Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
1322527|NCT02241551|Secondary|Time to Disease Progression||Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
1322528|NCT02241551|Secondary|Ca19-9 Response to Neoadjuvant Chemotherapy||Up to 5 years|Patient did not receive three cycles of treatment - data were not collected / zero total participants were analyzed.||||||
1322529|NCT02241551|Secondary|Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1|According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)|Up to 5 years|Patient was not treated - no data collected.||||||
1322530|NCT02241551|Secondary|R0 Resection Rates in Borderline Resectable Pancreatic Cancer||Up to 5 years|Patient did not receive three cycles of treatment - data were not collected.||||||
1322531|NCT02241551|Primary|Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control|Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.|up to 5 years|Patient did not receive three cycles of treatment - data were not collected.||||||
1322532|NCT02241486|Primary|Pain Relief|Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.|60 min|No participants are included in this analysis because the trial was terminated prematurely. As a result, data to assess primary and secondary study aims are incomplete or entirely unavailable for summary or statistical comparisons.||||||
1322533|NCT02241187|Secondary|Safety of Administration of PEGPH20 and Cetuximab|in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.|1 year|The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.||||||
1322534|NCT02241187|Primary|Effects of PEGPH20|administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.|1 year|The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.||||||
1322535|NCT02240680|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term ‘baseline’ refers to the last observation prior to the administration of any randomised study medication|Baseline and Week 24|Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.|||milligram/decilitre||Standard Error|Least Squares Mean
1322536|NCT02240680|Secondary|Percentage of Patients With HbA1c Lowering by at Least 0.5%.|The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.|24 weeks|Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.|||Percentage of patients (%)||95% Confidence Interval|Number
1322537|NCT02240680|Secondary|Percentage of Patients With HbA1c on Treatment <7.0%|This is the percentage of patients with HbA1c on treatment <7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.|24 weeks|Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.|||Percentage of Patients (%)||95% Confidence Interval|Number
1322654|NCT02239679|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all) Unknown"|Week 52||||Participants|||Count of Participants
1322538|NCT02240680|Secondary|Percentage of Patients With HbA1c<8.0%|This is the percentage of patients with HbA1c on treatment <8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.|24 weeks|Full analysis set (Non-completers considered failure)(FAS (NCF)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.|||Percentage of patients (%)||95% Confidence Interval|Number
1322539|NCT02240680|Secondary|Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.|Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.|24 weeks|Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.|||Percentage of patients (%)||95% Confidence Interval|Number
1322540|NCT02240680|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.|This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term ‘baseline’ refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.|Baseline and Week 24|Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.|||Percentage (%) of HbA1c||Standard Error|Least Squares Mean
1322541|NCT02240654|Primary|Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.|"Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.~Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.~SPAF:Stroke & systemic embolism in adult patients with non-valvular AF"|Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.|The study population included new users of dabigatran etexilate in the study period. New users were defined as those patients who initiated treatment with dabigatran etexilate during the study period and who had not used it during the previous year.|||percentage of participants||95% Confidence Interval|Number
1322542|NCT02240628|Secondary|Pain Intensity|"A blinded independent observer will rate pain on Propofol injection according to a pain scale.~No pain.~Mild pain(associated with facial expression of pain).~Moderate Pain(Pulling/withdrawal of arm).~Severe Pain(Screaming)."|During Propofol injection.||||participants|||Number
1322543|NCT02240628|Primary|Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.||During propofol injection.||||participants|||Number
1322544|NCT02240589|Secondary|Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)|The TBI-QOL Anger item bank includes 38 hierarchically ordered items designed to measure the full continuum of anger in a way which is both sensitive and appropriate for TBI. The TBI-QOL Anger item bank can be administered as a computer-adaptive test (CAT), allowing precise measurement of self-reported anger using only 4-8 adaptively selected items. Using CAT technology, an individual participant’s responses to the TBIQoL Anger scale generated a T-score (Mean=50; SD=10) with a range of 0 (lowest anger) to 100 (greatest anger).|Week 24||||scaled score||Standard Deviation|Mean
1322545|NCT02240589|Secondary|Behavior Rating Inventory of Executive Function (BRIEF) Inhibit|The Behavior Rating Inventory of Executive Function (BRIEF) Inhibit subscale is a rating scale completed by the participant and independently by an observer that assesses the ability to control impulses (inhibitory control) and to stop engaging in a behavior. The frequency of behaviors indicated by items is rated on a 3-point scale (never, sometimes, often). The raw score for the Inhibit subscale is the sum of ratings for the 8 items included in this measure. This sum was converted to a T-score (mean=50; SD=10) for analysis. Higher scores suggest a higher level of dysfunction in a specific domain of executive functions.|Week 24||||t-score||Standard Deviation|Mean
1322546|NCT02240589|Secondary|Stroop Interference|Stroop Interference Test is a neuropsychological test to assess a person's executive function. Specifically, the test is thought to reflect selective attention, cognitive flexibility and processing speed. The raw score for this measure is the number of items correctly identified within 45 seconds. The raw score was converted to a T-score (mean=50; SD=10) for analysis. Higher scores reflect better performance and less interference on reading ability.|Week 24||||t-score||Standard Deviation|Mean
1322573|NCT02239926|Secondary|Mean Abdominal Pain|Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.||||||
1322547|NCT02240589|Secondary|Trail Making Part B|Neuropsychological test of visual attention and executive functioning. The trail making tests are thought to reflect a variety of cognitive processes including attention, visual search and scanning, sequencing and shifting, psychomotor speed, abstraction, flexibility, ability to execute and modify a plan of action, and ability to maintain two trains of thought simultaneously. In Trails B, the participant is instructed to draw lines to connect numbers and letters in an alternating numeric and alphabetic sequence as rapidly as possible. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded. The unit of measure in seconds is converted to a scaled score (mean =10, SD = 3) using the Heaton et al. norms with lower scores indicating better performance.|Week 24||||scaled score||Standard Deviation|Mean
1322548|NCT02240589|Secondary|BVMT-R Learning|Brief Visuospatial Memory Test-Revised (BVMT-R) Learning measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) over 3 learning trials. The Learning raw score is the sum of the higher number of correctly recalled designs on either Trial 2 or Trial 3 minus the number of correctly recalled designs on Trial 1. A higher score is a better score. The raw score was converted to a T-score (Mean=50; SD=10) for analysis.|Week 24||||t-score||Standard Deviation|Mean
1322549|NCT02240589|Secondary|Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall|Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) after a 25 minute delay. The delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score. The raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis.|Week 24||||t-score||Standard Deviation|Mean
1322550|NCT02240589|Secondary|CVLT-II Trials 1-5 Free Recall Total|Neuropsychological test used to assess an individual's verbal memory abilities. California Verbal Learning Test-Second Edition (CVLT-II) Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis. The total A1–5T score reflects accurate recall over the five learning trials of the first list, and is most often used as a summary index of learning on the CVLT-II, with higher scores reflecting better performance.|Week 24||||t-score||Standard Deviation|Mean
1322551|NCT02240589|Primary|California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall|Neuropsychological test used to assess an individual's verbal memory abilities. The California Verbal Learning Test-Second Edition (CVLT-II) Long Delay Free Recall measures total word list items recalled after a 20-minute delay. The raw score is converted to a Z-score (Mean=0; SD=1) which was used for statistical analysis. Higher scores reflect worse performance (i.e., more recall errors) on this variable.|Week 24||||z-score||Standard Deviation|Mean
1322552|NCT02240368|Secondary|Entropy Awaking|In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia||||units on a scale||Inter-Quartile Range|Median
1322553|NCT02240368|Secondary|BISPECTRAL Index Awaking|In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia||||units on a scale||Inter-Quartile Range|Median
1322554|NCT02240368|Primary|Entropy|"The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.~Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours||||units on a scale||95% Confidence Interval|Number
1322555|NCT02240368|Primary|BISPECTRAL Index|"The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.~Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours||||units on a scale||95% Confidence Interval|Number
1322556|NCT02240329|Primary|Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution|The total cough count (CTot) was determined by counting all cough events that occurred following each presentation of capsaicin solution. CTot was made, in real time, by two investigators and confirmed via review of the recorded cough airflow signal. Capsaicin concentration necessary to elicit a two cough threshold response (C2) within 30 seconds of presentation, on at least two (out of three) trials of that concentration, was identified from the cough count record. An average across all measurements was performed for the analysis.|Day 1||||cough events following stimulation||Standard Deviation|Mean
1322557|NCT02240329|Primary|Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration|Following 30 seconds of tidal breathing (to allow for acclimation to the facemask), participants were instructed to “take a sharp breath in” whereupon the nebulized capsaicin solution was automatically administered by the dosimeter. Following each aerosol presentation, the participant was instructed to rate their UTC using a modified Borg Rating Scale where 1 = no UTC and 10 = maximum UTC. Between presentations, participants were given a minimum of a one-minute rest period where they were offered water. An average across all measurements was performed for the analysis.|Day 1||||Units on a Borg scale||Standard Error|Mean
1322559|NCT02240030|Secondary|UPDRS Part III at 10 Min.|Change from Predose in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.|week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||units on a scale||95% Confidence Interval|Least Squares Mean
1322560|NCT02240030|Secondary|Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12|Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.|week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||Participants|||Count of Participants
1322561|NCT02240030|Secondary|UPDRS Part III Motor Score at 20 Minutes|Change from Predose in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.|at week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||units on a scale||97.5% Confidence Interval|Least Squares Mean
1322562|NCT02240030|Secondary|Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.|Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed|at week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||Participants|||Count of Participants
1322563|NCT02240030|Primary|Unified Parkinson’s Disease Rating Scale (UPDRS) Part III|Primary Efficacy Analysis: Change from Predose in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.|30 minutes post-dose at week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||units on a scale||Standard Error|Least Squares Mean
1322564|NCT02239978|Secondary|Cortical Excitability|Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.|TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.|"As noted in our protocol, TMS was assessed in a subgroup of participants with PD. Seven of the 28 PD participants and 0 of the control group (healthy adults) were assessed. PD participants were assessed ON and OFF levodopa. We chose this approach because 1) this aim was exploratory in nature, and 2) MEPs of healthy adults are well characterized."|||% max stim output||Standard Deviation|Mean
1322565|NCT02239978|Secondary|Change in First Step Length|Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication||||meters||Standard Deviation|Mean
1322566|NCT02239978|Primary|Change in Steps After Postural Perturbation|Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication|"We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms."|||Number of steps||Standard Deviation|Mean
1322567|NCT02239978|Primary|Change in Movement of Center of Mass (COM) After Postural Perturbation|Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication|"We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms."|||meters||Standard Deviation|Mean
1322568|NCT02239939|Other Pre-specified|Changes in Lower Extremity Physical Function|SPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.|Baseline and 22 weeks||||units on a scale||Standard Deviation|Mean
1322569|NCT02239939|Other Pre-specified|Change in Body Weight|Body weight|Baseline and 22 weeks||||kg||Standard Deviation|Mean
1322570|NCT02239939|Secondary|Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)|"Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where 0' equals no fatigue at all, and 5 equals extreme fatigue."|baseline and 22 weeks||||units on a scale||Standard Deviation|Mean
1322571|NCT02239939|Secondary|Change in Hip Bone Density|Hip bone density as measured by DXA.|Basleine and 22 weeks||||g/cm2||95% Confidence Interval|Mean
1322572|NCT02239939|Primary|Change in Lean Mass Measured by DXA|Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).|Baseline and 22 weeks||||Kg||Standard Deviation|Mean
1322584|NCT02239692|Secondary|Frequency and Intensity of Adverse Events||From baseline (screening) up to day 10 after colonoscopy|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.|||subjects|||Number
1322574|NCT02239926|Primary|Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).|BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.||||||
1322575|NCT02239770|Secondary|Mean Systolic Blood Pressure|Systolic blood pressure was measured using an electronic sphygmomanometer just prior to film administration and at every 30 minutes after film administration for the duration of each study visit.|Part 1: Systolic blood pressure was measured at baseline and at every 30 minutes, up to 180 minutes post film administration. Part 2: Systolic blood pressure was measured at baseline and at every 30 minutes, up to 660 minutes post film administration.|Participants in Part 1 of the study were not assessed past 180 minutes post film administration, as this was the extent of the study visit.|||mmHg||Standard Deviation|Mean
1322576|NCT02239770|Secondary|Questionnaire of Smoking Urges-Brief Mean Total Score by Dose Group|"The Questionnaire of Smoking Urges-Brief (QSU-Brief) with a possible total score range of 10 to 70 was used to measure cigarette craving at baseline and at several points throughout the study visit for each participant. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving.~Part 1: The QSU-Brief was measured at baseline and at 15, 35, 55, 80, 140, and 200 minutes post film administration.~Part 2: The QSU-Brief was measured at baseline and at 50, 110, 230, 290, 410, 470, 590, and 690 minutes post FIRST film administration."|Part 1: The QSU-Brief was measured at baseline and at 15, 35, 55, 80, 140, and 200 minutes post film administration. Part 2: The QSU-Brief was measured at baseline and at 50, 110, 230, 290, 410, 470, 590, and 690 minutes post FIRST film administration.|This was a two part study. Participants in Part 1 and Part 2 were not assessed on the QSU-Brief measure at the same time intervals due to the differing study visit structures.|||score on a scale||Standard Deviation|Mean
1322577|NCT02239770|Primary|Peak Plasma Nicotine Concentrations Following Ingestion of a Single (Phase 1) or Repeated (Phase 2) Doses of Nicotine Film|"In Phase 1, a trained nurse will implant an intravenous (IV) indwelling catheter in each participant. Participants will place a film containing zero, 2, or 4 mg of nicotine in their mouths and blood will be drawn every 10 minutes thereafter for the next 60 minutes, and then every 30 minutes for the next 2 hours (11 blood draws in all over 3 hours after using the nicotine film).~In Phase 2, all 12 participants will receive an IV catheter and randomly allocated to consume 4 films over 12 hours in each of the following orders (a) 0,0,0,0 mg (b) 2,2,2,2 or (c) 4,4,0,4. A blood sample will be drawn at baseline prior to each film administration, and then at 30, 45, 60 and 120 minutes after each film administration and when the film is reported dissolved (20 blood draws in total)."|10 min - 12 hours|Because the placebo nicotine film does not deliver any nicotine to the blood, peak plasma nicotine levels cannot be observed in the 0 mg Nicotine Film arm (Part 1) and 0, 0, 0, 0 mg Nicotine Film Regimen (Part 2).|||ng/mL||Full Range|Mean
1322578|NCT02239744|Secondary|Fractional Exhaled Nitric Oxide|FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.|within 1 hour after the two-day intervention||||ppb||Standard Deviation|Geometric Mean
1322579|NCT02239744|Primary|Lung Function|A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers’ recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.|Within 1 hour after the end of the two-day intervention|Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time.|||L||Standard Deviation|Geometric Mean
1322580|NCT02239744|Secondary|Blood Pressure|After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.|Within one hour after the 2-day intervention||||mmHg||Standard Deviation|Geometric Mean
1322581|NCT02239744|Primary|Circulating Biomarkers|Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.|Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days||||ng/ml||Standard Deviation|Geometric Mean
1322582|NCT02239692|Secondary|Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)|Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.|||subjects|||Number
1322583|NCT02239692|Secondary|Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)|Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.|||subjects|||Number
1322586|NCT02239692|Primary|Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.|||score on a scale||Standard Deviation|Mean
1322587|NCT02239692|Primary|Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.|||score on a scale||Standard Deviation|Mean
1322588|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322589|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322590|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322591|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322592|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322593|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322594|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||Participants|||Count of Participants
1322595|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Screening||||Participants|||Count of Participants
1322655|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 4|Analysis population consisted of observed data; ie. subjects with data at Week 4.|||Participants|||Count of Participants
1322596|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322597|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322598|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322599|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322600|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322601|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322602|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||Participants|||Count of Participants
1322603|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Screening||||Participants|||Count of Participants
1322604|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322605|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322606|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322607|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322608|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322609|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322610|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1||||Participants|||Count of Participants
1322611|NCT02239679|Other Pre-specified|Stinging/Burning|"﻿Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.~STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable"|During PDT #1||||Participants|||Count of Participants
1322612|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||Participants|||Count of Participants
1322613|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Screening||||Participants|||Count of Participants
1322614|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322615|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322616|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322617|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322618|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322619|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322620|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1||||Participants|||Count of Participants
1322621|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||Participants|||Count of Participants
1322622|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Screening||||Participants|||Count of Participants
1322623|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322624|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322679|NCT02238925|Secondary|Serum Copper Levels Change From Baseline|Change from Baseline to Induction 1, Day 5|During 1st induction (up to 5 days)|All subjects who received at least 1 dose of study drug and copper data were collected.|||μg/dL||Standard Deviation|Mean
1322625|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322626|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322627|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322628|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322629|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1||||Participants|||Count of Participants
1322630|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||Participants|||Count of Participants
1322631|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Screening||||Participants|||Count of Participants
1322632|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322633|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322634|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322635|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322636|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322681|NCT02238782|Primary|Absolute Bioavailability|To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100|0 to 72 hours post-dose||||% of bioavailability||90% Confidence Interval|Geometric Mean
1322637|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322638|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Baseline||||Participants|||Count of Participants
1322639|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Screening||||Participants|||Count of Participants
1322640|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322641|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322642|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322643|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322644|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322645|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after photodynamic therapy (PDT) #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322646|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||Participants|||Count of Participants
1322647|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Screening||||Participants|||Count of Participants
1322648|NCT02239679|Secondary|Duration of Response|Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first|within 52 weeks after Baseline|Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.|||weeks||Standard Deviation|Mean
1322649|NCT02239679|Secondary|Recurrence Rate|Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).|Week 52|Analysis population consisted of observed data only|||number of lesions|number of lesions||Count of Units
1322650|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 52|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322651|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 36|Analysis population consisted of observed data only|||Participants|||Count of Participants
1322656|NCT02239679|Primary|Total Number of AKs in Treatment Area|Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.|Week 52|Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.|||lesions||Standard Error|Least Squares Mean
1322657|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 4||||Degrees||Standard Deviation|Mean
1322658|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 3||||Degrees||Standard Deviation|Mean
1322659|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 2||||Degrees||Standard Deviation|Mean
1322660|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4||||Units on a scale||Full Range|Mean
1322661|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3||||Units on a scale||Full Range|Mean
1322662|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4||||Units on a scale||Full Range|Mean
1322663|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2||||Units on a scale||Full Range|Mean
1322664|NCT02239289|Secondary|Fear of Movement Level|Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.|Week 4||||units on a scale||Full Range|Mean
1322665|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3||||Units on a scale||Full Range|Mean
1322666|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2||||Units on a scale||Full Range|Mean
1322667|NCT02239289|Secondary|Disability Level|Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.|Week 4||||units on a scale||Full Range|Mean
1322668|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 1||||Degrees||Standard Deviation|Mean
1322669|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 4||||ratio||Standard Deviation|Mean
1322670|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 3||||ratio||Standard Deviation|Mean
1322671|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 2||||ratio||Standard Deviation|Mean
1322672|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 1||||Ratio||Standard Deviation|Mean
1322673|NCT02239094|Primary|Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8|"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.~Nine of the items are based upon patient report, and one is on the rater’s observation during the rating interview. MADRS items are rated on a 0–6 continuum (0=no abnormality, 6=severe)."|Week 8||||units on a scale||Standard Deviation|Mean
1322674|NCT02239094|Primary|Montgomery-Asberg Rating Scale for Depression (MADRS)|"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.~Nine of the items are based upon patient report, and one is on the rater’s observation during the rating interview. MADRS items are rated on a 0–6 continuum (0=no abnormality, 6=severe)."|Baseline||||units on a scale||Standard Deviation|Mean
1322675|NCT02238977|Primary|Depression Severity|"Depression severity as measured by the 25-item Hamilton Depression Rating Scale. The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient/participant and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score the more severe the depression. The scale is scored by summing the total of all items. The maximum possible total score is 66 and the minimum is 0. A score > 17 is considered compatible with a diagnosis of major depression. A score < 10 is considered clinical remission.~The interview and scoring takes about 15 minutes."|up to 12 weeks|Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.|||units on a scale|||Number
1322676|NCT02238925|Secondary|Cmax||Induction 1, Day 5||||ng/ml||Standard Deviation|Mean
1322677|NCT02238925|Secondary|Tmax||Induction 1, Day 5||||hours||Full Range|Median
1322678|NCT02238925|Secondary|Complete Response Rate||Following 1st induction, following 2nd induction if applicable|Efficacy population: All subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
1342698|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
1322682|NCT02238483|Secondary|Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough FEV1/FVC Ratio||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||L/L||Standard Deviation|Mean
1322683|NCT02238483|Secondary|Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Vital Capacity (FVC)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||Litres||Standard Deviation|Mean
1322684|NCT02238483|Secondary|Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Expiratory Volume in 1 Second (FEV1)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||Litres||Standard Deviation|Mean
1322685|NCT02238483|Secondary|Dyspnea (Transitional Dyspnea Index (TDI) Score)|The Baseline/Transitional Dyspnea Index (BDI/TDI) provides a multidimensional measure of dyspnea in relation to activities of daily living. The BDI provides a measure of dyspnoea at a single state, the baseline, and the TDI evaluates changes in dyspnoea from the baseline state. The instrument consists of three components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these three components are rated in five grades from 0 (severe) to 4 (unimpaired), and are summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea are rated for each component by seven grades from -3 (major deterioration) to +3 (major improvement), and are added to form a total TDI score from -9 to +9. Positive scores indicate an improvement, and a change from the BDI or a difference between treatments of 1 point has been estimated to constitute the minimum clinically important difference.|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. Only patients with post-baseline TDI scores were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1322686|NCT02238483|Secondary|Health Related Quality of Life (as Assessed by St Georges Respiratory Questionnaire for COPD Patients [SGRQ-C])|The SGRQ-C is a modified version of the St. George’s Respiratory Questionnaire, which has been developed to measure the impact of respiratory disease on health status. The SGRQ-C includes 14 questions in 3 domains: symptoms; activity; and impacts. Scores range from 0 to 100 with higher scores indicating benefit. Change in total score from pre study-treatment baseline to Week 12 end of treatment visit are reported.|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||scores on a scale||Standard Deviation|Mean
1322687|NCT02238483|Secondary|Symptoms of COPD (Using the EXACT for Respiratory Symptoms [E-RS] Total Score, a Subset of Items From the EXACT Diary)|The EXACT for Respiratory Symptoms (E-RS) scale is a derivative instrument comprising a subset of 11 of the EXACT items to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||scores on a scale||Standard Error|Least Squares Mean
1322688|NCT02238483|Secondary|Annual Exacerbation Rate of Symptom Defined Exacerbations (as Defined by the EXACT Daily Diary)|"For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date – Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Exacerbations / year||Standard Error|Least Squares Mean
1322689|NCT02238483|Secondary|Time to First Symptom Defined Exacerbation (as Defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] Daily Diary)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
1322690|NCT02238483|Secondary|Annual Exacerbation Rate of Moderate and Severe Exacerbations (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)|"For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date – Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Exacerbations / year||Standard Error|Least Squares Mean
1322691|NCT02238483|Secondary|Time to First Moderate or Severe Exacerbation (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
1322714|NCT02238080|Secondary|Serum IL-6 Level||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1322715|NCT02238080|Secondary|Serum CRP Level||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.|||milligrams per liter (mg/L)||Standard Deviation|Mean
1322692|NCT02238483|Secondary|Annual Exacerbation Rate of Moderate and Severe Exacerbations|"For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date – Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Exacerbations / year||Standard Error|Least Squares Mean
1322693|NCT02238483|Secondary|Time to First Moderate or Severe Exacerbation||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
1322694|NCT02238483|Secondary|Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs (Including Drop-outs Due to Any Cause)|"For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Event Rate = No. of Events*365.25 / (Follow-up date – Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Events / year||Standard Error|Least Squares Mean
1322695|NCT02238483|Secondary|Time to First Event of Moderate or Severe COPD Exacerbations or Early Drop-out (Including Drop-outs Due to Any Cause)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
1322696|NCT02238483|Secondary|Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs Related to Worsening of COPD Symptoms (i.e. Composite Endpoint, ExDo)|"For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Event Rate = No. of Events*365.25 / (Follow-up date – Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Events / year||Standard Error|Least Squares Mean
1322697|NCT02238483|Primary|Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
1322698|NCT02238379|Secondary|Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer|Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.|Within 30 minutes of study visit commencing|1 participant lost to follow-up; data indicates number of participants with alcohol in their system|||Participants|||Count of Participants
1322699|NCT02238379|Secondary|Number of Participants Endorsing Substance Use|The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, & O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.|Within 30 minutes of study visit commencing|1 participant lost to follow-up; count of participants where substance dependence indicated|||Participants|||Count of Participants
1322700|NCT02238379|Secondary|Early Experience|"The investigators will employ the Parental Bonding Instrument (Parker, Tupling, & Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from very like to very unlike. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39."|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss); 1 participant did not know their father and did not complete the measure for paternal assessment|||units on a scale||Standard Deviation|Mean
1322701|NCT02238379|Secondary|Stress|The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)|||units on a scale||Standard Deviation|Mean
1322716|NCT02238080|Secondary|Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories.|||mcg/kg||Standard Deviation|Mean
1342699|NCT01910389|Secondary|Change in MLHFQ Score From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.||||||
1322702|NCT02238379|Secondary|Anxiety|The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)|||units on a scale||Standard Deviation|Mean
1322703|NCT02238379|Secondary|Smoking|Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.|Within 30 minutes of study visit commencing|1 participant was lost to follow-up|||Participants|||Count of Participants
1322704|NCT02238379|Secondary|Depression|The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)|||units on a scale||Standard Deviation|Mean
1322705|NCT02238379|Primary|Latency Non-Social|The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); 2 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis|||milliseconds||Standard Deviation|Mean
1322706|NCT02238379|Primary|Latency Social|The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis|||milliseconds||Standard Deviation|Mean
1322707|NCT02238379|Primary|Amplitude Non-Social|The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)|||microvolts||Standard Deviation|Mean
1322708|NCT02238379|Primary|Amplitude Social|The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participant was a statistical outlier and removed from oxytocin and placebo arms|||microvolts||Standard Deviation|Mean
1322709|NCT02238080|Secondary|Serum Hemoglobin Level||Baseline, Month 6|ITT population. 'Number analyzed' included participants evaluable for individual categories.|||grams per deciliter (g/dL)||Standard Deviation|Mean
1322710|NCT02238080|Secondary|Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose||Day 1|As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.||||||
1322711|NCT02238080|Secondary|Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose||Day 1|As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.||||||
1322712|NCT02238080|Secondary|Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
1322713|NCT02238080|Secondary|Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
1322717|NCT02238080|Secondary|Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis.|||percentage of participants|||Number
1322718|NCT02238080|Primary|Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Day 1|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
1322719|NCT02238080|Primary|Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Day 1|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
1322720|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322721|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
1322722|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322723|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
1322724|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322725|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
1322726|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for their preference of treatment frequency and baseline ESA frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Preferred treatment frequency included: once a month (O/M), twice a month (B/M), once a week (O/W), twice a week (B/W), three times a week (T/W) or other (any other frequency]). Frequency of baseline ESA use included: three times a week, twice a week, once a week, every 2 weeks (Q2W), every 4 weeks (Q4W) or other (any other frequency). Percentage of participants by each preferred treatment frequency and baseline ESA frequency was reported."|Baseline, Month 6|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322727|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by ESA Type|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and their preference of treatment frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency and ESA type was reported."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322756|NCT02237092|Secondary|Level of Sensory Blocks|Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra|After spinal anesthesia, average 20 minutes.||||Block level level of thoracic vertebrae||Standard Error|Median
1322728|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency was reported."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
1322729|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their need for improvement in the frequency of each treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'improvement is very necessary'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322730|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their need for improvement in the frequency of treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'Improvement is very necessary'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
1322731|NCT02238067|Secondary|Percentage of Participants With Interest in Learning to Inject Independently|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants responded 'yes' or 'no' to the question: 'Would you be interested in learning to inject independently?' ’ Percentage of participants who responded ‘yes’, was reported.|Baseline, Month 6|All enrolled participants who did not inject independently. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
1322732|NCT02238067|Secondary|Percentage of Participants by Different Injection Administration Modes|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked: 'How do you currently inject the anemia treatment?' and reported any of the 5 possible answers: Independently, by a family member, nurse at home, nurse at the clinic or other. Percentage of participants with each injection administration modes was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
1322733|NCT02238067|Secondary|Percentage of Participants by Different CKD Stages|Assessment was performed by physician via a satisfaction survey on anemia treatment. CKD stages were based on participant’s answer to the survey question. No specific method of assessment for CKD stage was specified. Percentage of participants with each CKD stage was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
1322734|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6. Here 'n' signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322735|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
1322736|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6|||percentage of participants||95% Confidence Interval|Number
1322737|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1322738|NCT02238067|Primary|Percentage of Participants by ESA Types at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6|||percentage of participants||95% Confidence Interval|Number
1322739|NCT02238067|Primary|Percentage of Participants by ESA Types at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.|Baseline|All enrolled participants|||percentage of participants||95% Confidence Interval|Number
1322757|NCT02237092|Primary|Classification Grade of Intra-abdominal Hypertension (IAH)|Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)|Before spinal anesthesia, average 10 minutes.||||mm Hg||Standard Error|Median
1322740|NCT02238028|Primary|Circulating Biomarkers——ET-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.|Up to 24 hours||||pg/ml||Standard Deviation|Geometric Mean
1322741|NCT02238028|Primary|Circulating Biomarkers——P- Selectin,VCAM-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours||||ng/ml||Standard Deviation|Geometric Mean
1322742|NCT02238028|Primary|Circulating Biomarkers——Fibrinogen，vWF|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours||||µg/ml||Standard Deviation|Geometric Mean
1322743|NCT02238028|Primary|Heart Rate Variability—pNN50|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.|Up to 24 hours||||percentage of ms||Standard Deviation|Geometric Mean
1322744|NCT02238028|Primary|Heart Rate Variability—LF/HF|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|Up to 24 hours||||ratio||Standard Deviation|Geometric Mean
1322745|NCT02238028|Primary|Heart Rate Variability-SDNN,SDANN, rMSSD|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.|Up to 24 hours||||ms||Standard Deviation|Geometric Mean
1322746|NCT02238028|Primary|Blood Pressure|The blood pressure were measured by automatic blood pressure monitor during the intervention study.|up to 24 hours||||mmHg||Standard Deviation|Mean
1322747|NCT02238028|Primary|Heart Rate Variability-LF Power,HF Power,VLF Power|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|up to 24 hours||||ms^2||Standard Deviation|Geometric Mean
1322748|NCT02237118|Secondary|Assessment of the Surrounding Skin.|assessment of the surrounding skin.|21 days||||percentage of patients|||Number
1322749|NCT02237118|Secondary|Safety|Adverse Event, Adverse Device Event|21 days||||Participants|||Count of Participants
1322750|NCT02237118|Secondary|Condition of the Wound, Will be Assesst by the Investigator.|wound size estimation, assesstemnt of the wound,|21 days|Missing value for some patients|||Participants|||Count of Participants
1322751|NCT02237118|Secondary|Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.|Complete healing at day 21, will be measured using PictZar system.|21 days||||percentage of wound size reduction||Standard Deviation|Mean
1322752|NCT02237118|Primary|Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)|To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.|21 days|intention to treat.Participants with None painfull dressing removal.|||participants|||Number
1322753|NCT02237092|Secondary|Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg||After spinal anesthesia, average 20 minutes.||||Number of pregnants with Blocks = > Th4|||Number
1322754|NCT02237092|Secondary|The Level of IAP|The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks|After spinal anesthesia, average 20 minutes.||||mm Hg||Standard Error|Median
1322755|NCT02237092|Primary|Obesity and IAP|Effect of obesity on the level of IAP|Before spinal anesthesia, average 10 minutes.||||mm Hg||Standard Error|Median
1322758|NCT02237092|Primary|The Level of Intra-abdominal Pressure (IAP)|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.|Before spinal anesthesia, average 10 minutes.||||mm Hg||Standard Error|Median
1322759|NCT02236767|Primary|The Saving Inventory-Revised (SI-R) Total Score|The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.|Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up||||units on a scale|||Number
1322760|NCT02236611|Primary|Change From Baseline in Trough FEV1 on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis|||Liter||Standard Error|Least Squares Mean
1322761|NCT02236598|Secondary|Changes in Insulin Sensitivity|Matsuda Insulin Sensitivity Index was calculated as: 10,000 / square root of [fasting glucose x fasting insulin x mean glucose x mean insulin during Oral Glucose Tolerance Test]).|Baseline to 3 months||||AUC - unitless,||Standard Deviation|Mean
1322762|NCT02236598|Secondary|Changes in Insulin Secretion as Measured by 2-hour Insulin Area-under-the-curve (AUC)|Changes in Insulin Secretion as measured by 2-hour insulin area-under-the-curve (AUC – measured via the trapezoidal method) of 2 hours from the 3-hour OGTT.|Baseline to 3 months||||AUC - pg*min/mL||Standard Deviation|Mean
1322763|NCT02236598|Secondary|Changes in Fasting, 1-hour, and 2-hour Post-challenge Glucose Levels in mg/dL|Changes in fasting, 1-hour, and 2-hour post-challenge glucose levels in mg/dL|Baseline to 3 months||||mg/dL||Standard Deviation|Mean
1322764|NCT02236598|Primary|Change in Glucose Tolerance as Measured by Area-under-the-curve|Change in glucose tolerance, as measured by change in glucose area-under-the-curve (Area Under the Curve (AUC) – measured via the trapezoidal method) of 2 hours from the 3-hour Oral Glucose Tolerance Test (OGTT).|Baseline to 3 months||||AUC - mg*min/dL||Standard Deviation|Mean
1322765|NCT02236546|Secondary|Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation|The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.|Baseline to day 21|Due to loss of funding data were not collected||||||
1322766|NCT02236546|Secondary|Progression-free Survival (PFS)|Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.|Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years|Due to loss of funding data were not collected||||||
1322767|NCT02236546|Secondary|Objective Response (OR)|The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.|Day 84|Due to loss of funding data were not collected||||||
1322768|NCT02236546|Primary|Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST|The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.|Baseline to the completion of 6 courses of treatment|Due to loss of funding data were not collected||||||
1322769|NCT02236338|Other Pre-specified|Incidence of Objective Post-procedure Bruising|Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.|During post procedure recovery period in clinic, an expected average of 2 hours after surgery.||||units on a scale||Full Range|Median
1322770|NCT02236338|Other Pre-specified|Incidence of Post-procedure Pain|Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.|During post procedure recovery period in clinic, an expected average of 2 hours after surgery.||||units on a scale||Full Range|Median
1322771|NCT02236338|Secondary|Incidence Rate of Acute Complications|Number of acute complications at one and 6 weeks post intervention|up to 6 weeks post intervention||||number of complications|||Number
1322772|NCT02236338|Primary|Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.||Annual follow up, up to 75 months|The mean long-term followup in the EVLA group was 44 (12–64) months, and the mean long-term follow-up in the RFA group was 42 (12–75) months.|||percentage of total participants|||Number
1322773|NCT02236130|Secondary|Patient/Family Satisfaction With Pain Management|Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.|one week after the surgery||||Participants|||Count of Participants
1322774|NCT02236130|Primary|Total Hydrocodone Dose (mg/kg)||day 2 and day 8 after the surgery||||mg/kg||Standard Deviation|Mean
1322816|NCT02234752|Secondary|Free Tryptophan (TRP)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||µM||Standard Deviation|Mean
1322775|NCT02235987|Primary|Participants With Trough Human Growth Hormone < 2.5 ug/mL||Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.|Baseline: an 8 hour untreated human growth hormone (hGH) profile was obtained in the period between 15 and 7 days prior to the first study treatment administration.|||participants with trough hGH < 2.5 µg/mL|||Number
1322776|NCT02235870|Other Pre-specified|Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group|Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)|6 Months|Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks|||Participants|||Count of Participants
1322777|NCT02235870|Primary|Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)|Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%|6 months|Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks|||Participants|||Count of Participants
1322778|NCT02235870|Primary|Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups|Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin|24 Weeks|Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks|||%TBL||Standard Error|Least Squares Mean
1322779|NCT02235831|Primary|Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.|Day 5, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).|||diopter*logMar|||Number
1322780|NCT02235493|Secondary|Performance-Oriented Mobility Assessment-Gait Subtest (POMA-G) - Change From Baseline to Last Overall|The POMA-G is a 7-component assessment that is used to evaluate gait performance. The second component has 4 sub-components. Scores of 0, 1 or 2 are assigned to 2 components while scores of 0 or 1 are assigned to the rest of the 4 components and 4 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients’ aged 5 to 15 years, inclusive.||||units on a scale||Inter-Quartile Range|Median
1322781|NCT02235493|Primary|Modified Performance-Oriented Mobility Assessment-Gait Subtest (MPOMA-G) - Change From Baseline to Last Overall|The MPOMA-G is a 5-component assessment that is used to evaluate gait performance. The first component has 4 sub-components. For 2 components and 2 sub-components, scores of 0 or 1 are assigned while scores of 0, 1 or 2 are assigned to the rest of the 2 components and 2 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients’ aged 5 to 15 years, inclusive.||||units on a scale||Inter-Quartile Range|Median
1322782|NCT02235454|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)|Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).|imaging approximately 10 minutes|All usable images of one eye of each participant|||correlation coefficient|||Number
1322783|NCT02235311|Secondary|Community-Acquired Pneumonia|As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment|8 weeks||||Participants|||Count of Participants
1322784|NCT02235311|Secondary|Clostridium Difficile Diarrhea|Clostridium difficile confirmed by polymerase chain reaction (PCR)|8 weeks||||Participants|||Count of Participants
1322785|NCT02235311|Secondary|Rate of Rebleed|"Per patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management~High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management"|8 weeks||||Participants|||Count of Participants
1322786|NCT02235311|Primary|Ulcer Healing|as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management|8 weeks|1 ulcer located in duodenum, clean-base; randomized single-blinded to proton pump inhibitor (PPI) twice daily|||Participants|||Count of Participants
1322787|NCT02235285|Primary|Post Surgical Complications and Reoperation Rate During Breast Augmentation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.|5 years||||percentage of participants||Standard Deviation|Mean
1322788|NCT02235077|Other Pre-specified|Day 60 Mortality|All participants will be contacted by telephone at 60 days, +/- 3 days post randomization to assess vital status (death).|60 days post randomization||||Participants|||Count of Participants
1322789|NCT02235077|Secondary|96 Hour Change in Dyspnea Visual Analog Scale|Dyspnea visual analog scale change from randomization to 96 hours. Scale range 0-100 with 100 being the best possible score.|Randomization to 96 hours||||units on a scale||Standard Deviation|Mean
1322790|NCT02235077|Secondary|Presence of Outpatient Worsening Heart Failure Symptoms Through Day 30|Outpatient worsening heart failure symptoms will be assessed from discharge through Day 30|Hospital discharge through Day 30|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||Participants|||Count of Participants
1322791|NCT02235077|Secondary|Change in Loop Diuretics Requirements From Baseline to 30 Days|Medications will be reviewed to assess loop diuretic dose requirements through Day 30 following randomization|Randomization through Day 30|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||mg||Standard Deviation|Mean
1322792|NCT02235077|Secondary|96 Hour Change in Serum Potassium Levels|Change in serum potassium levels at 96 hours as compared to baseline.|Baseline, 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||mEq/L||Standard Deviation|Mean
1322793|NCT02235077|Secondary|96 Hour Change in Body Weight|Baseline body weight assessment will be completed, and changes in weight documented daily through 96 hours or earlier discharge|Randomization through 96 hours or earlier discharge||||pounds||Standard Deviation|Mean
1322794|NCT02235077|Secondary|96 Hour Net Fluid Output|Fluid intake and urine output will be assessed daily while in hospital through 96 hours. Net fluid output (output minus input) through 96 hours is reported.|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||ml||Standard Deviation|Mean
1322795|NCT02235077|Secondary|96 Hour Change in Serum Creatinine|Renal function via serum creatinine, will be assessed at randomization and daily through 96 hours|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||mg/dl||Standard Deviation|Mean
1322796|NCT02235077|Secondary|96 Hour Change in Dyspnea Likert Score|Dyspnea relief via 7-point Likert scale will be assessed at randomization, 96 hours, and at discharge. The Likert score was defined as 1=markedly improved, 2=moderately improved, 3=minimally improved; 4=no change, 5=minimally worse, 6=moderately worse, and 7=markedly worse as compared with the degree of dyspnea present at randomization.|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||Participants|||Count of Participants
1322797|NCT02235077|Secondary|96 Hour Change in Clinical Congestion Score|Clinical congestion score will be assessed at randomization, 96 hours, and at discharge. Scale consisted of sum of six signs and symptoms of congestion, each scored 0-3. Zero indicates no sign/symptom and 3 indicates worst case of sign/symptom. Score range 0-18 with 18 being worst score.|Randomization through 96 hours||||units on a scale||Standard Deviation|Mean
1322798|NCT02235077|Primary|96 Hour Change in NT-proBNP|The Core Laboratory at Vermont will determine NT-proBNP levels for calculation of the endpoint from samples obtained at randomization and 96 hours respectively. NT-proBNP was converted to log scale.|Randomization to 96 hours||||log pg/ml||Standard Deviation|Mean
1322799|NCT02235064|Secondary|Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum||12 weeks postpartum||||Participants|||Count of Participants
1322800|NCT02235064|Secondary|Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum||8 weeks postpartum||||Participants|||Count of Participants
1322801|NCT02235064|Secondary|Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum||12 weeks postpartum||||Participants|||Count of Participants
1322802|NCT02235064|Secondary|Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum||8 weeks postpartum||||Participants|||Count of Participants
1322803|NCT02235064|Secondary|Reported Infant Weight at 12 Weeks Following Delivery||12 weeks postpartum||||Grams||Full Range|Mean
1322804|NCT02235064|Secondary|Reported Infant Weight at 8 Weeks Following Delivery||8 weeks postpartum||||Grams||Full Range|Mean
1322805|NCT02235064|Secondary|Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum||4 weeks postpartum||||Participants|||Count of Participants
1322806|NCT02235064|Secondary|Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum||4 weeks postpartum||||Participants|||Count of Participants
1322807|NCT02235064|Secondary|Reported Infant Weight at 4 Weeks Following Delivery||4 weeks postpartum||||Grams||Full Range|Mean
1322808|NCT02235064|Secondary|Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital|The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens|Discharge from hospital to 12 weeks postpartum||||Participants|||Count of Participants
1322809|NCT02235064|Primary|Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital|"Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment~0 = No postpartum depression up to 12 weeks following discharge from hospital~1 = Postpartum depression up to 12 weeks following discharge from hospital"|Discharge from hospital to 12 weeks postpartum||||Participants|||Count of Participants
1322810|NCT02234752|Secondary|PIC/KYN|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||AUC Ratio|||Number
1322811|NCT02234752|Secondary|KYNA/KYN|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||AUC Ratio|||Number
1322812|NCT02234752|Secondary|KYN/TRP|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||AUC Ratio|||Number
1322813|NCT02234752|Secondary|Picolinic Acid (PIC)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS* AUC is mass spectrometry times area under the curve.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||MS* AUC||Standard Deviation|Mean
1322814|NCT02234752|Secondary|Kynurenine (KYN)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||µM||Standard Deviation|Mean
1322815|NCT02234752|Secondary|Kynurenic Acid (KYNA)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS* AUC is mass spectrometry times area under the curve.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||MS* AUC||Standard Deviation|Mean
1322817|NCT02234752|Primary|Change in Level of Cognition|The primary outcome measure will be the change in level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). In schizophrenia, usual composite scores are 20-39. In healthy controls, usual composite scores are normalized to 40-60. Higher values of composite scores mean better cognition. Test scores are normalized to healthy controls, therefore no min-max range is available. Final scores calculated by MATRICS Consensus Cognitive Battery software. Exact minimum/maximum are not known to provider. Overall composite scores are reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||units on a scale|||Number
1322818|NCT02234479|Primary|Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy|The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.|12 months|Participants were analyzed for skin changes (during weekly visits with physician) during radiation treatment. Only 15 participants from each group completed the study, 1 subject from Group A and 3 subjects from Group B withdrew.|||participants|||Number
1322819|NCT02234427|Primary|Differential Gene Expression|Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area|2-weeks|The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.|||FPKM for HBG1 Gene||Standard Error|Mean
1322820|NCT02234362|Secondary|Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)|"Processing speed, working memory, visuospatial processing and attention was assessed by the Digit Symbol Substitution Test (DSST).~The DSST test requires the examinee to transcribe a unique geometric symbol with its corresponding Arabic number. The examinee is initially shown a key containing the numbers from 1 to 9. Under each number there is a corresponding geometric symbol. The examinee is then shown a series of boxes containing numbers in the top boxes, and blank boxes below them. After a short practice trial, they are then asked to copy the corresponding geometric symbol under each number. The raw score is the number of correct items completed within the prescribed time limit. Higher scores indicate faster processing speed, working memory, and visuospatial processing and attention. The range of scores is 0-63."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322821|NCT02234362|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)|"Menopause related symptoms were assessed using the Greene Climacteric Scale (GCS). The Greene Scale provides a brief measure of menopause symptoms. It can be used to assess changes in different symptoms, before and after menopause treatment. Three main areas are measured:~1. Psychological (items 1-11). 2. Physical (items 12-18). 3. Vasomotor (items 19, 20).~A higher score indicates that menopause symptoms are more bothersome. The range of scores is from 0 to 63."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322822|NCT02234362|Secondary|Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)|Pain symptoms were assessed by the Pain Assessment (PEG). The PEG is a three-item scale assessing pain intensity and interference. A higher score indicates more pain symptoms. The range of scores is from 0 to 30.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322823|NCT02234362|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)|Severity of illness was assessed by the Clinical Global Impression-Severity (CGI-S) Scale. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The range of scores is 0-7. Higher scores indicate greater severity of illness.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322824|NCT02234362|Secondary|Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)|Fatigue symptoms were assessed by the Clinical Global Impression-Fatigue (CGI-F) scale.The CGI-F is a single item global assessment scales to specifically evaluate symptoms of fatigue. Higher scores indicate more fatigue symptoms. The range of scores is from 0-7.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322849|NCT02233985|Primary|Score Respiratory Distress|It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.|Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay|All patients with respiratory distress in moderate to severe stage until a stage of mild respiratory distress or difficulty breathing submitted.|||units on a scale||95% Confidence Interval|Median
1322825|NCT02234362|Secondary|Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)|"Quality of life, menopause-specific, is assessed by the Menopause Specific Quality of Life (MENQOL).~The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a 1 and endorsement a 2, plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8. Higher scores indicate that menopause symptoms are more bothersome."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322826|NCT02234362|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)|Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. The range of scores is 0-21.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322827|NCT02234362|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)|Anxiety was measured by self-report responses to Beck Anxiety Inventory (BAI). It is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults. Higher scores on the BAI indicate more anxiety symptoms. The range of BAI scores is from 0 to 63, with 0-9=Minimal anxiety, 10-16=Mild anxiety, 17-29=Moderate anxiety, and 30-63=Severe anxiety.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322828|NCT02234362|Secondary|Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)|Cognition and physical functioning was measured by self-report responses to Cognitive and Physical Functioning Questionnaire (CPFQ).The range of scores is from 7-42. Higher scores indicate lower cognitive and executive functioning.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
1322829|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)|"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.~Severity of VMS:~The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe"|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||units on a scale||Standard Deviation|Mean
1322830|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||hot flashes per night||Standard Deviation|Mean
1322831|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)|"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.~Severity of VMS:~The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe"|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||units on a scale||Standard Deviation|Mean
1322832|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||hot flashes per day||Standard Deviation|Mean
1322850|NCT02233842|Primary|Time From Cancer Diagnosis to the Date of the Interview|Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).|up to 24 years||||years||Full Range|Median
1322833|NCT02234362|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)|The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60.|Baseline and Week 8 (Visit 5)|The analyzable population includes all 24 participants who initiated medication treatment and returned for at least one assessment after starting vortioxetine. A last observation carried forward (LOCF) analysis was used.|||units on a scale||Standard Deviation|Mean
1322834|NCT02234115|Secondary|Number of Participants With Adverse Events (AEs)|Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.|336 days|Safety population|||Participants|||Count of Participants
1322835|NCT02234115|Primary|Efficacy of Leuprolide Mesylate (LMIS 50mg)|The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).|baseline to 28 days, 28 days to 336 days|ITT|||percentage of participants||95% Confidence Interval|Mean
1322836|NCT02234011|Primary|Observing if Ketamine May Cause a Decrease in OCD Symptoms|"Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).~The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate."|Baseline to Week 5|One subject had a screening visit, but was never enrolled in the treatment portion and therefore never had any sort of treatment analysis performed on her data.||||||
1322837|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of PI scores of >= 2||Standard Deviation|Mean
1322838|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of PI scores of >= 3||Standard Deviation|Mean
1322839|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of MGI scores of >= 3||Standard Deviation|Mean
1322840|NCT02233998|Secondary|Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of BI scores of 0||Standard Deviation|Mean
1322851|NCT02233842|Primary|Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis|Current and former smokers who were smoking at the time of their cancer diagnosis.|Day 1 of interview||||participants|||Number
1322852|NCT02233842|Primary|Number of Smokers at the Time of the Interview|Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.|Day 1 of interview||||participants|||Number
1322841|NCT02233998|Secondary|Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of PI scores of 0 or 1||Standard Deviation|Mean
1322842|NCT02233998|Secondary|Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of MGI scores of 0 or 1||Standard Deviation|Mean
1322843|NCT02233998|Secondary|Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322844|NCT02233998|Primary|Whole Mouth Mean Plaque Index (PI) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322845|NCT02233998|Primary|Whole Mouth Mean Modified Gingival Index (MGI) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1322846|NCT02233985|Secondary|Frequency of Complications of the Disease Itself|The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.||2017-05-31|05/2017||||
1322847|NCT02233985|Secondary|Hospital Readmission|After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.||2017-05-31|05/2017||||
1322848|NCT02233985|Primary|Hours of Hospital Stay|Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.|All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge.|||hours||95% Confidence Interval|Median
1322853|NCT02233842|Primary|Number of Participants to Achieve Saturation in an English-language Paper Questionnaire|Saturation is defined as satisfactory measurement of performance without need of further review.|Last subject interviewed, an average of 5 months||||participants|||Number
1322854|NCT02233803|Secondary|Change From BL in Asthma Control Test (ACT) at 4 Wks for Each TP|ACT was basically a five item questionnaire, to measure participant’s asthma control. It comprised of five possible answers to each question, associated with a score of 1 to 5 (1=poor control and 5=good control), wherein the scores from each question were summed to give an overall score (5=poor control and 25=complete control). ACT was recommended during each visit and was completed by the participant before any procedures were performed, avoiding any influence of the participants response. Change from BL was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific(PS) BL, treatment group and period, with participant as random effect. PS BL value, is pre-dose assessment collected on D1 of each TP. SL BL, is arithmetic mean of PS BL values of participant. Participants with an ACT below 15 were excluded from the study.|BL up to W4 (each TP)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||units on scale||Standard Error|Least Squares Mean
1322855|NCT02233803|Secondary|FEV1 Area Under the Curve (AUC) (0-10 h) at D1 of Each TP|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. FEV1 AUC (0 to 10h) was measured at beginning of each TP. AUC was derived using values observed at the following timepoints: 0 minute (pre-morning dosing), 5 minutes (m), 15m, 30m, 1, 2, 5, and 10h; post morning dosing FEV1 values on D1 of each TP. Pre-dose was taken as, 0h timepoint on the visit of interest, and all subsequent timepoints were calculated relative to that timepoint. FEV1 AUC was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific(PS) BL, treatment group and period, with participant as random effect.|(0-10 h) at D1 (each TP)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||L*hrs||Standard Error|Least Squares Mean
1322856|NCT02233803|Primary|Change From Baseline (BL) in Trough Morning Forced Expiratory Volume in One Second (FEV1) at Day (D)29|FEV1 is maximal amount of air, forcefully exhaled in one second. Trough FEV1 is defined as morning prebronchodilator and predose: 12 hours (h) after last evening dose D28 at end of each TP. Measured by spirometer in morning, before using bronchodilator and pre-dosing at wk1 D1 and wk4 D29 of each TP and test was performed within 30 minutes prior to dosing. Change from BL was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific (PS) BL, treatment group and period, with participant as random effect. PS BL value is pre-dose assessment collected on D1 of each TP. SL BL is arithmetic mean of PS BL values of participant. If only one of PS BL value is missing for participant, SL BL took value of other BL. If both PS BL values were missing, SL BL was set to missing. Period level BL=PS BL - associated SL BL.|BL (D1) and D29 (each TP)|The intent to treat (ITT) population comprised of all randomized participants who received at least one dose of study treatment. This population was based on the treatment to which the participant was randomized. Only those participants with data available at the indicated time points were analyzed.|||Litre (L)||Standard Error|Least Squares Mean
1322857|NCT02233647|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322858|NCT02233647|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322859|NCT02233647|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322860|NCT02233647|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322861|NCT02233647|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322862|NCT02233647|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322916|NCT02231918|Primary|PTF|Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||% of PTF||Geometric Coefficient of Variation|Geometric Mean
1322863|NCT02233647|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322864|NCT02233647|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322865|NCT02233647|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322866|NCT02233647|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322867|NCT02233647|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322868|NCT02233647|Secondary|"Peak Ratings of Nauseated/Queasy/Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated/Queasy/Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322869|NCT02233647|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322870|NCT02233647|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322871|NCT02233647|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322872|NCT02233647|Secondary|"Peak Ratings of Good Effect on the Visual Analog Scale"|"Subjects rated their feelings of Good Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322873|NCT02233647|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322874|NCT02233647|Secondary|"Peak Ratings of Bad Effect on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322875|NCT02233647|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322876|NCT02233647|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322877|NCT02233647|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 stimulant items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322878|NCT02233647|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1322879|NCT02233647|Primary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||Degrees Fahrenheit||Standard Error|Mean
1322880|NCT02233647|Primary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||Beats per Minute||Standard Error|Mean
1322881|NCT02233647|Primary|Peak Diastolic Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
1322882|NCT02233647|Primary|Peak Systolic Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
1322883|NCT02233543|Secondary|Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation|The time during the night spent below 90 % in blood oxygen saturation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy.|Post 4 weeks administration of QVA149, post 4 weeks administration of placebo|Only randomized participants with data from both treatments were analyzed.|||Percent||Standard Error|Least Squares Mean
1322884|NCT02233543|Primary|Mean Night-time Blood Oxygenation|The mean night-time blood oxygenation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy.|Post 4 weeks administration of QVA149, post 4 weeks administration of placebo|Only randomized participants with data from both treatments were analyzed.|||Percent Oxygenation||Standard Error|Least Squares Mean
1322885|NCT02233309|Primary|Pressure in the Caudal Epidural Space|After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.|Immediately post bolus|Due to errors in data collection or protocol violations, 5 patients were excluded leaving 31 patients for analysis.|||mmHg||Standard Deviation|Mean
1322886|NCT02233296|Primary|Pharmacokinetics - AUC0-inf (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participants with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||ng.h/mL||Standard Deviation|Mean
1322917|NCT02231918|Primary|CLR,ss|Renal clearance of the analyte at steady state (CLR(0-12),ss ).|12h after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1322887|NCT02233296|Primary|Pharmacokinetics - AUC0-t (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participantss with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||ng.h/mL||Standard Deviation|Mean
1322888|NCT02233296|Secondary|Tolerability|Tolerability was defined as the number of participants that did not withdraw from the study early due to adverse events.|15 days|All the participants included in the study who received at least one dose of lasmiditan (n=30). Participant disposition was considered for all participants under the fed condition and then all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).|||participants|||Number
1322889|NCT02233296|Secondary|Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).|Safety was evaluated in all participants (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.|Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days|All the participants included in the study who received at least one dose of lasmiditan (n=30). Adverse events were considered in all participants under the fed condition and then in all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).|||participants with adverse events|||Number
1322890|NCT02233296|Primary|Pharmacokinetics - Tmax (Hours)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participants with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||hours||Standard Deviation|Mean
1322891|NCT02233296|Primary|Pharmacokinetics - Cmax (ng/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participants with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||ng/mL||Standard Deviation|Mean
1322892|NCT02233101|Secondary|Other Complications|"Any other complications listed below:~DVT or PE~Return to the OR within 30 days~Re-admission within 30 days~Superficial infection~Deep infection~Periprosthetic fracture~Cerebrovascular accident or Transient ischemic attack~Dislocation"|participants will be followed for the duration of hospital stay, an expected average of no more than 30 days||||participants|||Number
1322893|NCT02233101|Primary|Number of Participants Who Required Blood Transfusion|Patient hemoglobin will be measured during and after surgery for the first 24 hours to determine if a blood transfusion is indicated.|during or within 24 hours after surgery||||participants|||Number
1322894|NCT02232880|Secondary|Change in Inflammatory Markers|changes in plasma and T cell markers of activation and T cell cytokine production from randomization to end of 24 weeks of treatment|6 months|No patients received treatment prior to study termination||||||
1322895|NCT02232880|Secondary|Change in Brachial Artery Reactivity|change in brachial artery reactivity measured at randomization and after 24 weeks of treatment|6 months|No patients received treatment prior to study termination||||||
1322896|NCT02232880|Secondary|Change in Blood Pressure|Changes in the rate of change of blood pressure estimated by automated in office cuff measurements and ambulatory blood pressure at 12 weeks after randomization|6 months|No patients received treatment prior to study termination.||||||
1322897|NCT02232880|Primary|Change in Systolic Blood Pressure From Randomization to End of Treatment|Ambulatory blood pressure monitoring will be used at the end of the 4 weeks standardized treatment and at the end of 6 months randomized treatment with abatacept or placebo. The change in systolic blood pressure from these 2 recordings will be the primary endpoint.|6 months|No patients received treatment prior to study termination||||||
1322918|NCT02231918|Primary|fe 0-12,ss|Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).|12 hours after last study drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||% of PPX excreted||Geometric Coefficient of Variation|Geometric Mean
1322919|NCT02231918|Primary|Ae 0-12,ss|Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).|12 hours after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng||Geometric Coefficient of Variation|Geometric Mean
1322898|NCT02232698|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).~There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).~The ANCOVA adjusts for baseline DTSQs (status version)."|Baseline and Day 208||||units on a scale||Standard Deviation|Mean
1322899|NCT02232698|Secondary|System Utilisation|System utilisation assessed by percentage of sensor glucose data collected by the intervention group|Days 15 to 208|112 subjects included in the analysis, 7 were not included due to missing data.|||percentage of sensor glucose collected||Standard Deviation|Mean
1322900|NCT02232698|Secondary|Number of Glucose Measurements Performed|Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.|Days 1 to 208||||number of measurements per day||Standard Deviation|Mean
1322901|NCT02232698|Secondary|Time in Range|Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
1322902|NCT02232698|Secondary|Time Spent >180 mg/dL and >240 mg/dL|Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
1322903|NCT02232698|Secondary|Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL|Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194-208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||number of episodes per day||Standard Deviation|Mean
1322904|NCT02232698|Secondary|Time Spent <55 mg/dL and <40 mg/dL|Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
1322905|NCT02232698|Secondary|HbA1c at 6 Months|Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1|Baseline and Day 208||||percentage of Glycated Haemoglobin||Standard Deviation|Mean
1322906|NCT02232698|Primary|Time Spent <70 mg/dL|Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
1322907|NCT02232178|Primary|T1/2z|Terminal half-life.|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.|Per protocol PK population.|||hours||Standard Deviation|Mean
1322908|NCT02232178|Primary|Tmax|Time to maximum plasma concentration.|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.||||hours||Standard Deviation|Mean
1322909|NCT02232178|Primary|AUC0-last|Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.||||ng/mL∙hr||Standard Deviation|Mean
1322910|NCT02232178|Primary|Cmax|Maximum drug plasma concentration|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.||||ng/mL||Standard Deviation|Mean
1322911|NCT02232126|Secondary|30-day Readmission Among Intervention Participants|The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.|30-days|Analysis among Intervention group ONLY for this outcome|||30-day hospital readmissions|||Number
1322912|NCT02232126|Primary|30-day Hospital Readmission|The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.|30-days post hospitalization||||30-day hospital readmissions|||Number
1322913|NCT02231918|Secondary|Vital Signs (Pulse Rate)|Vital signs (Pulse rate (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h|Safety analysis set|||bpm||Standard Deviation|Mean
1322914|NCT02231918|Secondary|Vital Signs (Systolic and Diastolic Blood Pressure)|Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1322915|NCT02231918|Secondary|Number of Patients With Drug Related Adverse Events|Number of patients with adverse events due to study drug.|From first drug administration until 24 hours after last study drug administration, upto 48 days|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.|||participants|||Number
1322982|NCT02230995|Secondary|AUC0-infinity of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322920|NCT02231918|Primary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||L||Geometric Coefficient of Variation|Geometric Mean
1322921|NCT02231918|Primary|CL/F,ss|Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1322922|NCT02231918|Primary|MRTpo,ss|Mean residence time of the analyte in the body at steady state (MRTpo,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||h||Geometric Coefficient of Variation|Geometric Mean
1322923|NCT02231918|Primary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
1322924|NCT02231918|Primary|λz,ss|Terminal rate constant in plasma at steady state (λz,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1322925|NCT02231918|Primary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).|0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322926|NCT02231918|Primary|Tmin,ss|Time from dosing to minimum concentration at steady state (Tmin,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||hours||Full Range|Median
1322927|NCT02231918|Primary|Tmax,ss|Time from dosing to maximum concentration at steady state (Tmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||hours||Full Range|Median
1322928|NCT02231918|Primary|Cavg|Average concentration of the analyte in plasma at steady state (Cavg).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322929|NCT02231918|Primary|Cpre,N|Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322930|NCT02231918|Primary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Standard Deviation|Geometric Mean
1322931|NCT02231918|Primary|Cmax,ss|Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322932|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Tapping Frequency as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The tapping frequency was calculated as the number of taps between the onsets of the first and the last tap divided by the time in between. The mean changes from Baseline to Day 28 in the tapping frequency for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Hertz||Standard Deviation|Mean
1323064|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 758 Days||||Participants|||Count of Participants
1322933|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Variability of Peak TF as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the variability of TF for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
1322934|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of ITI as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of ITI for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322935|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IPI as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of IPI for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322936|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of TD as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of TD for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322937|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IOI as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of IOI for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322938|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Tapping Frequency as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The tapping frequency was calculated as the number of taps between the onsets of the first and the last tap divided by the time in between. The mean changes from Baseline to Day 28 in the tapping frequency for the left and right hands are presented as raw data. GLS mean ratios are in original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Hertz||Standard Deviation|Mean
1322939|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Variability of Peak TF as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the variability of TF for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
1322940|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of ITI as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of ITI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322941|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IPI as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IPI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322942|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of TD as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of TD for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322943|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IOI as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IOI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322957|NCT02231580|Primary|Numbers of Patients Experiencing Treatment Emergent Adverse Events (TEAEs).|The safety and tolerability of BN82451B versus placebo was determined after oral administration b.i.d. for 28 days in patients with HD. Numbers of patients experiencing TEAEs, including information on seriousness, intensity, drug relationship and those leading to withdrawal are presented for all doses of BN82451B and placebo.|From Day 1 to end of study (a period of up to 7 weeks).|The Safety Population consisted of all randomised patients who received at least one dose of study medication.|||Participants|||Number
1323065|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 393 Days||||Participants|||Count of Participants
1322944|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Tapping Frequency (Freq) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of TD in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The tapping frequency was calculated as the number of taps between the onsets of the first and the last tap divided by the time in between. The mean changes from Baseline to Day 28 in the tapping frequency for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Hertz||Standard Deviation|Mean
1322945|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Variability of Peak Tapping Forces (TF) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of TD in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the variability of TF for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
1322946|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Inter Tap Intervals (ITI) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of ITI in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of ITI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322947|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Inter Peak Intervals (IPI) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of tap IPI in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IPI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322948|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Tap Durations (TD) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of TD in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of TD for the left and right hands are presented a raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322949|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Inter Onset Intervals (IOI) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of tap IOI in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IOI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
1322950|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Isometric Grip Forces as Determined by Manumotography|The coordination of isometric grip forces in the precision grip between the thumb and index finger were assessed by Manumotography. Grip forces were assessed during grip initiation, object transport and in a static holding phase. Subjects were instructed to grasp and lift a device equipped with a force transducer and 3D position sensor in the precision grip between thumb and index finger and hold it stable adjacent to a marker 10 centimetres high. Grip forces and 3D position and orientation of the object were recorded. Mean isometric grip forces and grip force variability in the static phase (expressed as coefficient of variation = standard deviation/mean x 100 [GFV-C]) were calculated during a 15 second period. 5 trials of 20 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the mean isometric grip forces of each hand are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Newton||Standard Deviation|Mean
1322951|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Grip Force Variability as Determined by Manumotography|The coordination of isometric grip forces in the precision grip between the thumb and index finger were assessed by Manumotography. Grip forces were assessed during grip initiation, object transport and in a static holding phase. Subjects were instructed to grasp and lift a device equipped with a force transducer and 3D position sensor in the precision grip between thumb and index finger and hold it stable adjacent to a marker 10 centimetres high. Grip forces and 3D position and orientation of the object were recorded. Mean isometric grip forces and grip force variability in the static phase (expressed as coefficient of variation = standard deviation/mean x 100 [GFV-C]) were calculated during a 15 second period. 5 trials of 20 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the grip force variability of each hand are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
1322952|NCT02231580|Secondary|Change From Baseline to Day 28 in the Orientation-index as Determined by Choreomotography|Choreatic (involuntary) movements were assessed using Choreomotography by calculating a position-index and orientation-index. Patients were asked to grasp and lift a device equipped with an electromagnetic sensor, and were asked to hold the device as stable as possible. 3D changes in position (x, y and z) and orientation (roll, pitch and yaw) were recorded and used to calculate a position-index and an orientation-index. This method provided an objective measure of the involuntary movements. 5 trials of 20 seconds duration were performed with each hand, and the start and end of each trial was signalled by a cueing tone. The mean changes from Baseline to Day 28 in the orientation-index of the right and left hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||radians per second (radians/s)||Standard Deviation|Mean
1322953|NCT02231580|Secondary|Change From Baseline to Day 28 in the Position-index as Determined by Choreomotography|Choreatic (involuntary) movements were assessed using Choreomotography by calculating a position-index and orientation-index. Patients were asked to grasp and lift a device equipped with an electromagnetic sensor, and were asked to hold the device as stable as possible. Three dimensional (3D) changes in position (x, y and z) and orientation (roll, pitch and yaw) were recorded and used to calculate a position-index and an orientation-index. This method provided an objective measure of the involuntary movements. 5 trials of 20 seconds duration were performed with each hand, and the start and end of each trial was signalled by a cueing tone. The mean changes from Baseline to Day 28 in the position-index of the right and left hands are presented as raw data. The statistical analyses present geometric least squares (GLS) mean ratios in the original units.|Baseline (Day-1) to Day 28|The Pharmacodynamic (PD) population consisted of all subjects from the safety population who have not reported major protocol violations impacting quantitative measures of motor function (Q-motor) evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||metres per second (m/s)||Standard Deviation|Mean
1322954|NCT02231580|Secondary|Time to Peak Plasma Concentration (Tmax)|Tmax is the empirical time of Cmax and was determined for BN82451B and its metabolites BN2468 and BN7167 on Days 1, 14 and 28. Day 1 data represent the PK after the first dose (Tmax). The data for Days 14 and 28 represent the Tmax at steady state (Tmax,ss) at the initial cohort dose and following dose escalation, respectively. Data is presented for cohorts 1 and 2, as the study terminated prior to dosing of cohort 3.|Days 1, 14 and 28|The PK population consisted of all subjects from the safety population who had no major protocol deviations affecting the PK variables and who had a sufficient number of plasma BN82451B concentrations to estimate the main PK parameters.|||hours||Full Range|Median
1322955|NCT02231580|Secondary|Peak Plasma Concentration (Cmax)|Cmax was determined for BN82451B and its metabolites BN2468 and BN7167 on Days 1, 14 and 28. Day 1 data represent the PK after the first dose (Cmax). The data for Days 14 and 28 represent the Cmax at steady state (Cmax,ss) at the initial cohort dose and following dose escalation, respectively. Data is presented for cohorts 1 and 2, as the study terminated prior to dosing of cohort 3.|Days 1, 14 and 28|The PK population consisted of all subjects from the safety population who had no major protocol deviations affecting the PK variables and who had a sufficient number of plasma BN82451B concentrations to estimate the main PK parameters.|||ng/mL||Standard Deviation|Mean
1322956|NCT02231580|Secondary|Area Under the Plasma Concentration Time Curve (AUC)|The AUC was determined for BN82451B and its metabolites BN2468 and BN7167 within a dosage interval (0-12 hours) on Days 1, and 14 and 28. Day 1 data represent the AUC after the first dose (AUC[0-12]). The data for Days 14 and 28 (AUC[τ,ss]) represent the AUC at steady state at the initial cohort dose and following dose escalation, respectively. Data is presented for cohorts 1 and 2, as the study terminated prior to dosing of cohort 3.|0-12 hours on Days 1, 14 and 28|The PK population consisted of all subjects from the safety population who had no major protocol deviations affecting the PK variables and who had a sufficient number of plasma BN82451B concentrations to estimate the main PK parameters.|||hours*nanograms per millilitre (h*ng/mL)||Standard Deviation|Mean
1322958|NCT02231177|Secondary|Clinical Relevant Abnormalities in Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinically relevant abnormalities in vital signs (blood pressure and pulse rate), physical examination, blood chemistry, haematology, urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Any adverse events which occurred within 14 days following the last drug administration were assigned to the last study treatment administered.|From drug administration until 14 days following the last drug administration|Treated Set. All randomised patients who received at least one dose of trial medication were included in the treated set.|||participants|||Number
1322959|NCT02231177|Secondary|FEV1 Change From Baseline|"Mean change from baseline in forced expiratory volume in one second (FEV1). Pulmonary function test.~The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.|||L||Standard Deviation|Mean
1322960|NCT02231177|Secondary|FVC Change From Baseline|"Mean change from baseline in forced vital capacity (FVC). Pulmonary function test.~The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.|||L||Standard Deviation|Mean
1322961|NCT02231177|Secondary|Concentration of Tiotropium in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1322962|NCT02231177|Secondary|Concentration of Olodaterol in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1322963|NCT02231177|Secondary|Tmin,ss of Tiotropium|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
1322964|NCT02231177|Secondary|Tmin,ss of Olodaterol|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
1322965|NCT02231177|Secondary|Cmin,ss of Tiotropium|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1322966|NCT02231177|Secondary|Cmin,ss of Olodaterol|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1322967|NCT02231177|Secondary|fe(0-24,ss) of Tiotropium|"Fraction of Tiotropium eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||percentage of tiotropium dose||Geometric Coefficient of Variation|Geometric Mean
1322968|NCT02231177|Secondary|fe(0-24,ss) of Olodaterol|"Fraction of Olodaterol eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||percentage of olodaterol dose||Geometric Coefficient of Variation|Geometric Mean
1322969|NCT02231177|Secondary|Tmax,ss of Tiotropium|Time from dosing to the maximum concentration of Tiotropium in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
1322970|NCT02231177|Secondary|Tmax,ss of Olodaterol|Time from dosing to the maximum concentration of Olodaterol in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
1322971|NCT02231177|Secondary|AUC(0-tz,ss) of Tiotropium|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Tiotropium.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322972|NCT02231177|Secondary|AUC(0-tz,ss) of Olodaterol|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Olodaterol.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322973|NCT02231177|Secondary|AUC(0-4h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=4 h at steady state (AUC(0-4h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322974|NCT02231177|Secondary|AUC(0-2h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval 0 to 2 hours at steady state (AUC(0-2h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322975|NCT02231177|Secondary|Cmax,ss of Tiotropium|"Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1322976|NCT02231177|Secondary|AUC(0-6h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=6 h at steady state (AUC(0-6h,ss)).~As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Tiotropium. Based on the given definition AUC(0-6h,ss) was selected as secondary endpoint.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322977|NCT02231177|Secondary|Ae(0-24h,ss) of Olodaterol|"Amount of Olodaterol that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||ng||Geometric Coefficient of Variation|Geometric Mean
1322978|NCT02231177|Primary|Ae(0-24h,ss) of Tiotropium|"Amount of Tiotropium that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||ng||Geometric Coefficient of Variation|Geometric Mean
1322979|NCT02231177|Primary|Cmax,ss of Olodaterol|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1322980|NCT02231177|Primary|AUC(0-1h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval t1=0 to t2=1 hour at steady state (AUC(0-1h,ss)).~As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Olodaterol. Based on the given definition AUC(0-1h,ss) was selected as primary endpoint.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic (PK) set which included all patients in the treated set who provided at least one of the PK parameters in at least one treatment period and completed the trial without any important protocol violations, it is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1322981|NCT02231164|Primary|Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1|This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.|Up to 6 months.|Randomised Set: The randomised set included all randomised patients.|||Percentage of participants|||Number
1322983|NCT02230995|Secondary|AUC0-infinity of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
1322984|NCT02230995|Primary|Cmax of Metformin in Plasma|Maximum measured concentration of the metformin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1322985|NCT02230995|Primary|Cmax of Empagliflozin in Plasma|Maximum measured concentration of empagliflozin in plasma (Cmax)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1322986|NCT02230995|Primary|AUC0-tz of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|Pharmacokinetic Set (PKS): This analysis set included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1322987|NCT02230995|Primary|AUC0-tz of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
1322988|NCT02230956|Secondary|Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale|Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.|Baseline, Week 24|Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.|||score on a scale||Standard Deviation|Mean
1322989|NCT02230956|Secondary|Patient Global Impression of Change (GIC) Using a 7-Point Scale|The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.|Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1322990|NCT02230956|Secondary|Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale|The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1322991|NCT02230956|Secondary|Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale|The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1322992|NCT02230956|Primary|Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale|Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.|Baseline, Week 8|Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.|||score on a scale||Standard Deviation|Mean
1322993|NCT02230904|Secondary|Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||units on a scale||Standard Deviation|Mean
1323889|NCT02215161|Secondary|Incidence of Non-serious Adverse Events|Incidence of non-serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 3 years after treatment start||||events|||Number
1322994|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2|"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
1322995|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1|"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
1322996|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
1322997|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
1322998|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group “less than or equal to 70 % adhered or patch detachment” which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
1322999|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group “less than or equal to 70 % adhered or patch detachment” which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
1323042|NCT02230306|Secondary|Progression-free Survival (PFS)|Time (number of months) from first documented evidence of overall Complete Response (CR) or Partial Response (PR) until time of first documented disease progression or death due to any cause (for individual patients). Progression as defined by RECIST 1.1 (Response Evaluation Criteria In Solid Tumors) is a ≥ 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.|Up to 5 years|Patients who received study treatment and were assessed by MRI every 8 weeks.|||months|||Number
1323000|NCT02230904|Primary|Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = > 95 - 100 % of the patch area adheres~1 = > 90 - 95 % of the patch adheres~2 = > 85 - 90 % of the patch adheres~3 = > 80 - 85 % of the patch adheres~4 = > 75 - 80 % of the patch adheres~5 = > 70 - 75 % of the patch adheres~6 = ≥ 50 - 70 % of the patch adheres~7 = < 50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline.~The average of patches 1 and 2 is presented by Treatment Arm below."|Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||units on a scale||Standard Deviation|Mean
1323001|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 2 (PSS2)|Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21.|11 weeks|intention-to-treat|||units on a scale||Standard Deviation|Mean
1323002|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 1 (PSS1)|Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60.|0-11 weeks|intention-to-treat|||units on a scale||Standard Deviation|Mean
1323003|NCT02230761|Primary|Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported|Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.|11 weeks|intention-to-treat|||participants|||Number
1323004|NCT02230683|Secondary|Concentration of Caspase 3/7 RLU|Median change of concentration of Caspase 3/7 Relative Light Units from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT||||RLU||Full Range|Median
1323005|NCT02230683|Secondary|Change in Aspartate Aminotransferase (AST)|Median change of AST from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT||||U/L||Full Range|Median
1323006|NCT02230683|Secondary|Change in Alanine Aminotransferase (ALT)|Median change of ALT from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT||||U/L||Full Range|Median
1323007|NCT02230683|Primary|Change in cCK18/M30|Median change of caspase-cleaved cytokeratin serum levels (cCK18/M30) from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)||||U/L||Full Range|Median
1323008|NCT02230683|Primary|cCK18/M30|Absolute Mean Change of caspase-cleaved cytokeratin serum levels (cCK18/M30); the statistical analysis is based on the mean change in log-transformed cCK18/M30 from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Change from Baseline to Day 28/EOT||||U/L||Standard Deviation|Mean
1323009|NCT02230683|Primary|Hepatic Venous Pressure Gradient (HVPG)|Mean change of HVPG [mmHg] from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)|23 subjects were enrolled, of whom 22 were evaluable for the HVPG endpoint. 1 subject discontinued at day 1.|||mmHg||Standard Deviation|Mean
1323010|NCT02230670|Secondary|Change From Baseline to Month 3 in MELD Score|"The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula:~MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43~MELD scores are reported as whole numbers, so the result of the equation above is rounded. Notes: If the patient has been dialyzed twice within the last 7 days, then the value for serum creatinine used should be 4.0. Any value less than one is given a value of 1 (i.e. if bilirubin is 0.8, a value of 1.0 is used) to prevent the occurrence of scores below 0 (the natural logarithm of 1 is 0, and any value below 1 would yield a negative result). The higher the MELD score the more severe the disease state."|3 Months|FAS|||units on a scale||Standard Error|Least Squares Mean
1323011|NCT02230670|Primary|Change From Baseline at Month 3 in cCK18/M30|Data was log-transformed for analysis purposes|3 months|Full analysis set|||U/L||Standard Error|Least Squares Mean
1323012|NCT02230670|Primary|Change From Baseline at Month 3 in cCK18/M30|Baseline, Month 3, and change between for cCK18/M30|3 months|FAS|||U/L||Full Range|Median
1323013|NCT02230566|Secondary|Change From Baseline in Impactful Clinical Problem Total Score at UX003 Treatment Week 24|The 3 most impactful clinical problems as reported by the subject/parent/caregiver during the Clinical Problem Evaluation were scored on a Likert scale from 1 (very little problem) to 7 (an extreme amount) at randomization and post-randomization visits. At post-randomization visits, each clinical problem was again scored for impact on daily activities. Total scores ranged from 3 to 21; lower scores reflect less impact on daily life. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) The change from baseline up to UX003 Treatment Week 24 were analyzed by GEE modeling, including baseline value, and the post-UX003 initiation treatment week as a categorical variable. The covariance structure within participants is assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Error|Least Squares Mean
1323043|NCT02230306|Secondary|Overall Response|Response to study treatment achieved by individual patients as indicated by an overall change in size of the sum of diameters from baseline of up to 5 intracranial target lesions and up to 5 extracranial target lesions.|Until disease progression, less than or equal to 5 years.|Patients who received study treatment and were assessed by MRI every 8 weeks.|||centimeters|||Number
1323014|NCT02230566|Secondary|Percentage of Individual Clinical Response (ICR) Responders at UX003 Treatment Week 24|Percentage of participants who were ICR responders based on MID criteria at Week 24. At the Randomization visit, the physician queried the participant or parent/caregiver about signs and symptoms of MPS VII that interfered most with the participant’s daily life. Answers were mapped to an appropriate clinical outcome measure (e.g., difficulty walking could map to the 6MWT; breathing problems to FVC). The clinical outcome ranked with the highest impact on daily life that could be reliably completed by the participant and met a threshold level of impairment was selected as the ICR for that participant. ICR response was assessed based on a positive change (according to pre-specified MID criteria) of each participant’s ICR. Agresti–Coull confidence interval with nominal coverage ≥ 95%.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||percentage of participants||95% Confidence Interval|Number
1323015|NCT02230566|Secondary|Change From Baseline in Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale at UX003 Treatment Week 24|The PedsQL 18-item scale is comprised of 3 dimensions: general fatigue (6 items), sleep/rest fatigue (6 items) and cognitive fatigue (6 items). Each item has a 5-point Likert response scale that is reverse scored and transformed to a 0 to 100 scale with higher scores indicating less fatigue. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Change from baseline in PedsQL total fatigue score was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and ≥1 post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Error|Least Squares Mean
1323016|NCT02230566|Secondary|Change From Baseline in Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) Scores at UX003 Treatment Week 24|BOT-2 was administered to evaluate treatment-related changes in 4 domains assessing both fine and gross motor function: balance (score 0 to 37), fine motor precision (score 0 to 41), manual dexterity (score 0 to 45), and running speed/agility (score 0 to 52). Higher scores indicate more motor proficiency; a positive change from baseline indicates improvement. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Change from baseline in BOT-2 was analyzed by GEE modeling based on observed data. The GEE model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Error|Least Squares Mean
1323017|NCT02230566|Secondary|Change From Baseline in Uncorrected Visual Acuity at UX003 Treatment Week 24|Visual acuity was measured (corrected and uncorrected) using a standard eye chart and recorded for each eye independently. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. The change in the number of lines from pre-treatment baseline to 24 weeks of treatment was evaluated. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) A positive change from baseline indicates improvement. Change from baseline in uncorrected visual acuity was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and at least one post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||lines||Standard Error|Least Squares Mean
1323018|NCT02230566|Secondary|Change From Baseline in Shoulder Flexion and Extension Maximum Range of Motion at UX003 Treatment Week 24|Goniometry was used to measure (in degrees) the maximum passive shoulder range of motion in both flexion and extension. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Change from baseline in shoulder flexion-left was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and at least one post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||degrees||Standard Error|Least Squares Mean
1323019|NCT02230566|Secondary|Change From Baseline in Pulmonary Function Testing: Maximum Ventilatory Ventilation (MVV) at UX003 Treatment Week 24|Spirometry was administered to participants who did not require invasive ventilatory support or have a tracheostomy to measure MVV. The percent predicted values were calculated after testing using published normative data. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.)|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|No change from baseline was calculated and no GEE analysis was performed due to lack of data at baseline and/or UX003 Treatment Week 24.||||||
1323020|NCT02230566|Secondary|Change From Baseline in Pulmonary Function Testing: Percentage of Predicted Forced Vital Capacity (FVC%Pred) at UX003 Treatment Week 24|Spirometry was administered to participants who did not require invasive ventilatory support or have a tracheostomy and measured percentage of predicted FVC. The percent predicted values were calculated after testing using published normative data. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) No GEE analysis was performed for FVC due to the limitation of the sample size.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||percentage predicted FVC||Standard Deviation|Mean
1323021|NCT02230566|Secondary|Change From Baseline in 6-Minute Walk Test (6MWT) at UX003 Treatment Week 24|The total distance walked (in meters) in a 6-minute period was measured. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) A positive change from Baseline indicates improvement. Change from baseline in 6MWT was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and at least one post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||meters||Standard Error|Least Squares Mean
1323022|NCT02230566|Secondary|Multi-Domain Responder Index (MDRI) Score at UX003 Treatment Week 24|MDRI score, calculated as the total response score at UX003 Treatment Week 24 across 6 domains: 6-Minute Walk Test, forced vital capacity predicted value, shoulder flexion, visual acuity, and Bruininks-Oseretsky Test of Motor Proficiency fine motor and gross motor capacity. For each domain, a minimally important difference (MID) was pre-specified. Changes from before treatment (baseline) to 24 weeks after treatment in each domain variable were scored against pre-specified MIDs. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) An improvement or decline ≥ MID was scored either as a +1 or -1, respectively, and a change <MID was scored as 0. The integration of benefit occurred by summing the responses (-1, +1, 0) across all 6 domain variables to derive the MDRI score, with a range of -6 (greatest possible decline) to +6 (greatest possible improvement).|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Deviation|Mean
1323023|NCT02230566|Primary|European Union (EU) and Rest of World: Percentage Change From Baseline in Urinary Glycosaminoglycan (uGAG) Dermatan Sulfate (DS) at UX003 Treatment Week 24|"Baseline was defined as the average of all assessments prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect was subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Percent change from baseline in uGAG DS was analyzed by generalized estimating equation (GEE) modeling based on observed data. The GEE model included included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within subjects was assumed to be exchangeable.~In the United States (US), this was considered a secondary outcome measure. Per guidance from the Food and Drug Administration (FDA), no primary efficacy variable was declared in the US. Efficacy was to be based on the totality of the clinical data on a per participant basis."|Baseline (defined as the average of all assessments prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||percentage change||Standard Error|Least Squares Mean
1323044|NCT02230306|Primary|Objective Intracranial Response (OIRR)|Change in overall size of the sum of diameters from baseline of up to 5 intracranial target lesions in response to study treatment, achieved by individual patients.|Until disease progression, less than or equal to 5 years.|Patients who received study treatment and were assessed by MRI every 8 weeks.|||centimeters|||Number
1323066|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 208 Days||||Participants|||Count of Participants
1323024|NCT02230540|Primary|Residual Volume Less Than 100ml|"The primary endpoint was “Residual volume less than 100 ml (Yes/No)” assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.~Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.~Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from “300ml – collected volume <100ml” to “collected volume > 200ml”, were used to interpret the primary endpoint."|2-4 hours||||Subjects with successful catheterization|||Number
1323025|NCT02230384|Other Pre-specified|Adverse and Serious Adverse Events|Monitoring of reported or elicited Adverse and Serious Adverse Events|6 weeks|||||||
1323026|NCT02230384|Secondary|Laboratory and EKG Measures|Labs and EKG will be done at screening and end of the 6 week study, in addition Liver and Renal and Hematology Labs will be drawn two more times in each phase to assess safety|Once at baseline screening, and once at the end of the study|||||||
1323027|NCT02230384|Secondary|Monitoring of Psychiatric Symptoms Including Psychopathology and Suicidal Behavior|Psychiatric symptoms and suicide ratings using Positive and Negative Syndrome Scale (PANSS) and the Columbia Suicide Severity Rating Scale (CSSRS) scales will determine ongoing safety, and will be conducted at each visit in each 3 week phase of the study|Once at every scheduled visit|||||||
1323028|NCT02230384|Secondary|Cognitive Functions|Performance on standardized cognitive tasks to determine potential mechanisms of drug efficacy|Assessed at Visits 2, 9, 11 and 18|||||||
1323029|NCT02230384|Secondary|Withdrawal When Quit|Severity of withdrawal symptoms will be assessed with standard self-report measures each day during the quit week only of each phase. Data will be analysed when quit criteria were met.|during each quit week|||||||
1323030|NCT02230384|Primary|Quit Status|"Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week)~Numbers reported are collapsed across medication conditions for each medication order."|Daily - Mon-Fri during the quit week in each phase|All participants who completed Phase 1 and Phase 2 of the of the study were included in the analysis.|||days abstinent||Standard Error|Mean
1323031|NCT02230332|Other Pre-specified|Fractional Exhaled Nitrix Oxide||8 weeks after randomization||||parts per billion||95% Confidence Interval|Geometric Mean
1323032|NCT02230332|Other Pre-specified|Asthma Control Test (ACT)|Asthma Control Test : Score calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled.|8 weeks after randomization||||units on a scale||95% Confidence Interval|Mean
1323033|NCT02230332|Other Pre-specified|Salivary Alpha Amylase Ratio (Post-Salmeterol / Pre-Salmeterol)|Salivary Alpha Amylase (sAA) levels from saliva samples obtained through passive drooling, before and 1 hour after Salmeterol administration. The outcome is expressed as the ratio of the Post-Salmeterol to the Pre-Salmeterol sAA levels.|8 weeks after randomization||||ratio||95% Confidence Interval|Mean
1323034|NCT02230332|Secondary|Beta-2 Adrenergic Receptor Agonist-induced cAMP Production|Peripheral blood mononuclear cells cAMP concentrations measured using isoproterenol (ISO) as a beta-2 adrenergic receptor agonist, and using phosphate buffered saline (PBS) as a positive control. The outcome is expressed as the ratio of cAMP concentration using ISO relative to cAMP concentration using PBS.|8 weeks after randomization||||ratio||95% Confidence Interval|Geometric Mean
1323035|NCT02230332|Secondary|Peripheral Blood Mononuclear Cell ADRB2 Cell Surface Density||8 weeks after randomization||||number of receptors per cell||95% Confidence Interval|Geometric Mean
1323036|NCT02230332|Primary|Salmeterol Protected Methacholine Challenge PC20|Following administration of Salmeterol, the concentration of Methacholine required to produce a 20% drop in FEV1 - measured in mg/ml and reported on log base 2 scale.|8 weeks after randomization||||mg/ml on log base 2 scale||95% Confidence Interval|Mean
1323037|NCT02230306|Secondary|Health-related Quality of Life as Measured by The Functional Assessment of Cancer Therapy (FACT) - Brain (FACT-Br)|"The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales. The brain subscale is usually used along with the core (general) questionnaire that includes 27 items. The measure yields information about total QOL, as well as information about the dimensions of physical well-being, social/family well-being, emotional well being, functional well-being, and disease-specific concerns. Patients rate all 5 items using a five-point Likert scale ranging from 0 not at all to 4 very much. Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items). Scoring range is 0-200."|Up to 5 years||||scores on a scale|||Number
1323038|NCT02230306|Secondary|Early Markers of Progression in Peripheral Blood||Up to 5 years|Zero participants were analyzed for this outcome.||||||
1323039|NCT02230306|Secondary|Immune Modulation in Peripheral Blood||Up to 5 years|Data were not able to be collected and thus zero participants were analyzed for this outcome.||||||
1323040|NCT02230306|Secondary|Duration of Response|Change in relative apparent diffusion coefficient (rADC) as measured by MRI as early predictor of response value/result for each patient|Until disease progression, less than or equal to 5 years.|Patients for whom response duration data was obtainable in those that received MRI tumor assessments every 8 weeks.|||months|||Number
1323041|NCT02230306|Secondary|Overall Survival (OS)|Number of months of survival for individual patients.|Up to 5 years||||months|||Number
1323045|NCT02230085|Primary|CPAP Therapy Adherence|Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.|90 days|103 patients CPAP therapy adherence data was collected. 3 patients data was either lost or unable to be downloaded.|||participants|||Number
1323046|NCT02229864|Secondary|Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 1123 days||||Participants|||Count of Participants
1323047|NCT02229864|Secondary|Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 393 days||||Participants|||Count of Participants
1323048|NCT02229864|Secondary|Number of Subjects With Late Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|31 to 393 days||||Participants|||Count of Participants
1323049|NCT02229864|Secondary|Number of Subjects With Subacute Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|>1 to 30 days||||Participants|||Count of Participants
1323050|NCT02229864|Secondary|Number of Subjects With Acute Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|≤ 1 day||||Participants|||Count of Participants
1323051|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 1123 Days||||Participants|||Count of Participants
1323052|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 758 Days||||Participants|||Count of Participants
1323053|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 393 Days||||Participants|||Count of Participants
1323054|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 208 Days||||Participants|||Count of Participants
1323055|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 37 Days||||Participants|||Count of Participants
1323056|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
1323057|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 1123 Days||||Participants|||Count of Participants
1323058|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 758 Days||||Participants|||Count of Participants
1323059|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 393 Days||||Participants|||Count of Participants
1323060|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 208 Days||||Participants|||Count of Participants
1323061|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 37 Days||||Participants|||Count of Participants
1323062|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
1323063|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 1123 Days||||Participants|||Count of Participants
1323067|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 37 Days||||Participants|||Count of Participants
1323068|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
1323069|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 1123 Days||||Participants|||Count of Participants
1323070|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 758 Days||||Participants|||Count of Participants
1323071|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 393 Days||||Participants|||Count of Participants
1323072|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 208 Days||||Participants|||Count of Participants
1323073|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 37 Days||||Participants|||Count of Participants
1323074|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
1323075|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 1123 Days||||Participants|||Count of Participants
1323076|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 758 Days||||Participants|||Count of Participants
1323077|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 393 Days||||Participants|||Count of Participants
1323078|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 208 Days||||Participants|||Count of Participants
1323079|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 37 Days||||Participants|||Count of Participants
1323080|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
1323081|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 1123 Days||||Participants|||Count of Participants
1323082|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 758 Days||||Participants|||Count of Participants
1323083|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 393 Days||||Participants|||Count of Participants
1323084|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 208 Days||||Participants|||Count of Participants
1323085|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 37 days||||Participants|||Count of Participants
1323086|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
1323087|NCT02229864|Primary|Drug Clearance (CL)|"The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~Calculated as: CL = Dose/AUC0 - ∞ ."|0 to 30 days||||Liter/hour||Full Range|Median
1323088|NCT02229864|Primary|Terminal Elimination Half-life (t1/2term)|"The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~calculated as: t1/2term = 0.693/λz."|0 to 30 days||||Hours||Full Range|Median
1323089|NCT02229864|Primary|Terminal Elimination Rate Constant (λz)|The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.|0 to 30 days||||1/hour||Full Range|Median
1323119|NCT02229487|Primary|GLP-1 Levels in Response to Oral Glucose Tolerance Test|Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels|2 weeks||||pmol/l.h||Inter-Quartile Range|Median
1325417|NCT02182895|Primary|Mean Daily Blood Glucose Levels During Hospital|mean of average daily blood blood glucose for each patient day|Hospital days 2-5|Inpatients with diabetes|||mg/dL||Standard Deviation|Mean
1323090|NCT02229864|Primary|AUC 0-infinity|"AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~calculated as: AUC0-∞ = AUClast + (Clast/λz)~The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:~%AUC0-∞ex = (AUC0-∞ – AUClast)/ AUC0-∞ * 100"|0 to 30 days||||ng*h/mL||Full Range|Median
1323091|NCT02229864|Primary|AUC Last|Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.|0 to 30 days||||ng*h/mL||Full Range|Median
1323092|NCT02229864|Primary|AUC24h|Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.|0 to 24 hours||||ng*h/mL||Full Range|Median
1323093|NCT02229864|Primary|Time of Maximum (Tmax)|Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days||||Hours||Full Range|Median
1323094|NCT02229864|Primary|Maximum Concentration (Cmax)|Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days||||nanograms per milliliter||Full Range|Median
1323095|NCT02229539|Secondary|Alternative Analgesics Use in the Continuation Phase||Up to 4 hours post-treatment|||||||
1323096|NCT02229539|Secondary|Pain Score in the Continuation Phase||Up to 4 hours post-treatment|||||||
1323097|NCT02229539|Secondary|The Length of Time in the Continuation Phase||Up to 4 hours post-treatment|||||||
1323098|NCT02229539|Secondary|Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase, as Measured by Item 9 in the Patient-reported Questionnaire After 4 Hours||Up to 4 hours post-treatment|||||||
1323099|NCT02229539|Secondary|The Incidence of Using Alternative Analgesics Between 1 and 4 Hours After Initial Mouthwash||Up to 4 hours post-treatment|||||||
1323100|NCT02229539|Secondary|The Total Drowsiness Increase as Measured by the Numerical Analogue Scale of Drowsiness Questionnaires||Up to 4 hours post-treatment every 4 hours while on treatment|||||||
1323101|NCT02229539|Secondary|The Total Stinging or Burning From the Oral Rinse as Measured by the Numerical Analogue Scale of Stinging or Burning From the Oral Rinse in the Questionnaires||Up to 4 hours post-treatment|||||||
1323102|NCT02229539|Secondary|The Total Unpleasant Taste of the Oral Rinse as Measured by the Numerical Analogue Scale of Taste of the Oral Rinse in the Questionnaires||Up to 4 hours post-treatment|||||||
1323103|NCT02229539|Primary|Mean Area Under the Curve (AUC) of Total Pain Reduction|Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis.|Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment|All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and had mouth and throat pain data at baseline and at least one time point beyond baseline.|||units on a scale*time scale||Standard Deviation|Mean
1323104|NCT02229513|Secondary|Requirement of Cesarean Hysterectomy||During surgery and in the PACU (approximately 3 total hours)||||participants|||Number
1323105|NCT02229513|Secondary|Total Blood Loss Greater Than 1000 cc||Intra-op, Post-Op||||participants|||Number
1323106|NCT02229513|Secondary|Requirement of Blood Products||During surgery and in the PACU (approximately 3 total hours)||||participants|||Number
1323107|NCT02229513|Secondary|Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions||Intraoperatively||||participants|||Number
1323108|NCT02229513|Secondary|Bakri Bulb Placement||Intraoperatively||||participants|||Number
1323109|NCT02229513|Secondary|Use of Cytotec||Intraoperatively||||participants|||Number
1323110|NCT02229513|Secondary|Use of Hemabate||Intraoperatively||||participants|||Number
1323111|NCT02229513|Secondary|Use of Methergine||Intraoperatively||||participants|||Number
1323112|NCT02229513|Other Pre-specified|Uterine Temperature After Wrap Removed||Immediately following hysterotomy repair||||degrees Fahrenheit||Standard Deviation|Mean
1323113|NCT02229513|Other Pre-specified|Total Time Uterus Wrapped||During hysterotomy repair||||minutes||Standard Deviation|Mean
1323114|NCT02229513|Other Pre-specified|Patient Temperature||Pre-op, Intra-op, Post-Op||||degrees Fahrenheit||Standard Deviation|Mean
1323115|NCT02229513|Secondary|Use of Extra Oxytocin||Intraoperatively||||participants|||Number
1323116|NCT02229513|Secondary|Use of Uterotonic Medications||During surgery and in the PACU (approximately 3 total hours)||||participants|||Number
1323117|NCT02229513|Secondary|Change in Pre- vs Post-operative Hematocrit||48 hours post operative period||||percent||Standard Deviation|Mean
1323118|NCT02229513|Primary|Blood Loss|At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.|During surgery and in the PACU (approximately 3 total hours)||||cc||Standard Deviation|Mean
1323120|NCT02229474|Secondary|Zarit Burden Interview|The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.|Immediately post-intervention|people attending CST|||units on a scale||Inter-Quartile Range|Median
1323121|NCT02229474|Secondary|Hospital Anxiety and Depression Scale|The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.|Immediately post-intervention|People attending CST|||units on a scale||Inter-Quartile Range|Median
1323122|NCT02229474|Secondary|Adapted Alzheimer's Disease Assessment Scale-cognitive Scale|The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.|Immediately post-intervention|People attending CST|||units on a scale||Standard Deviation|Mean
1323123|NCT02229474|Secondary|Identification and Intervention for Elderly Africans Cognitive Screen|The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.|Immediately post-intervention|People attending CST|||units on a scale||Inter-Quartile Range|Median
1323124|NCT02229474|Secondary|Zarit Burden Interview|The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.|Baseline|People attending CST|||units on a scale||Inter-Quartile Range|Median
1323125|NCT02229474|Secondary|Hospital Anxiety and Depression Scale|The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.|Baseline|People attending CST|||units on a scale||Inter-Quartile Range|Median
1323126|NCT02229474|Secondary|Adapted Alzheimer's Disease Assessment Scale-cognitive Scale|The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.|Baseline|people attending CST|||units on a scale||Standard Deviation|Mean
1323127|NCT02229474|Secondary|Identification and Intervention for Elderly Africans Cognitive Screen|The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.|Baseline|people attending CST|||units on a scale||Inter-Quartile Range|Median
1323128|NCT02229474|Secondary|World Health Organization Brief Quality of Life Scale|The scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.|Four weeks post intervention|people atending CST sessions|||units on a scale||Inter-Quartile Range|Median
1323129|NCT02229474|Primary|World Health Organization Brief Quality of Life Scale|The WHOQOL-Bref will assess quality of life in patients and carers. The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale|Immediately post-intervention|Groups attending CST sessions|||units on a scale||Inter-Quartile Range|Median
1323130|NCT02229474|Primary|World Health Organization Brief Quality of Life Scale|The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale|Baseline|Analysis for QOL data comparing pre- and post intervention scores|||units on a scale||Inter-Quartile Range|Median
1323131|NCT02229461|Secondary|Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 1 at time point Day 7/1 Hour, Day 7/3 Hour, Day 7/6 Hour, Day 7/12 Hour was 12.|||percentage||95% Confidence Interval|Mean
1323132|NCT02229461|Secondary|Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 4 at time point Day 7/1 Hour was 12; 11 in group 6, 7 in Group 5, 12 in Group 6 at Day 16/1 Hour.|||percentage||95% Confidence Interval|Mean
1323133|NCT02229461|Secondary|Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)|Percentages are based on the number of participants in the Evaluable Population in each treatment group.|||percentage||95% Confidence Interval|Mean
1323134|NCT02229461|Primary|Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value – Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.|At hour 24 on Day 16 post treatment|Percentages are based on the number of participants in the Evaluable Population in each treatment group.|||percentage||95% Confidence Interval|Mean
1323135|NCT02229396|Secondary|Change in Systolic Blood Pressure From Baseline to Week 28|To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1323136|NCT02229396|Secondary|Percentage of Patients Achieving HbA1c <7% at Week 28|To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% of patients||95% Confidence Interval|Number
1323137|NCT02229396|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 2|To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 2|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1323138|NCT02229396|Secondary|Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28|To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% of patients||95% Confidence Interval|Number
1323139|NCT02229396|Secondary|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test|To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1323140|NCT02229396|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 28|To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment|||mg/dL||95% Confidence Interval|Least Squares Mean
1323141|NCT02229396|Secondary|Change in Body Weight From Baseline to Week 28|To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||kg||95% Confidence Interval|Least Squares Mean
1323142|NCT02229396|Primary|Change in HbA1c From Baseline to Week 28|To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% HbA1c||95% Confidence Interval|Least Squares Mean
1323143|NCT02229383|Secondary|Change in Seated SBP From Baseline to Week 28|To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1323144|NCT02229383|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 28, no Weight Gain at Week 28, and no Major Hypoglycemia Over 28 Weeks|To compare the percentage of patients achieving HbA1c <7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% of patients||95% Confidence Interval|Number
1323145|NCT02229383|Secondary|Change From Baseline to Week 28 in Daily Insulin Dose|To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||units||95% Confidence Interval|Least Squares Mean
1323146|NCT02229383|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 28|To compare the percentage of patients achieving HbA1c <7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% of patients||95% Confidence Interval|Number
1323147|NCT02229383|Secondary|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test|To compare the change from baseline in 2-hour postprandial glucose after a standard Meal Tolerance Test achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1323148|NCT02229383|Secondary|Change in Body Weight From Baseline to Week 28|To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||kg||95% Confidence Interval|Least Squares Mean
1342700|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.||||||
1323149|NCT02229383|Primary|Change in HbA1c From Baseline to Week 28|To compare the change from baseline in HbA1c achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% HbA1c||95% Confidence Interval|Least Squares Mean
1323150|NCT02229318|Secondary|Ease of Preparation of FruitiVits|"Ease of preparation of FruitiVits was rated on a scale of 1-5:~(very easy)~(moderately easy)~(neither easy nor difficult)~(moderately difficult)~(very difficult).~Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients"|Day 8 of trial|Children aged 4 to 8 years.|||participants|||Number
1323151|NCT02229318|Primary|Acceptability of FruitiVits|"The study product was rated on a scale of 1-5:~(liked very much)~(liked moderately)~(neither liked nor disliked)~(disliked moderately)~(disliked very much)."|Day 8 of trial|Children aged 4 to 8 years.|||participants|||Number
1323152|NCT02229227|Secondary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters|A single 12-lead ECG recordings were performed in a participant in semi recumbent position for 10 to 15 minutes before obtaining the ECG. Any clinically significant favorable and unfavorable findings are reported.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1323153|NCT02229227|Secondary|Number of Participants With Vital Signs of Clinical Concern|Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values. Assessment of vitals were performed with the participant in a semi recumbent or seated position having rested in this position for at least 5 minutes before each reading. The potential clinical concern values were: SBP: <100 millimeters of mercury (mmHg) and >170 mmHg, DBP: <50 mmHg and >110 mmHg and pulse rate: <50 beats per minute (bpm) and > 120 bpm. Number of participants with vital signs of clinical concern are presented.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1323154|NCT02229227|Secondary|Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26|Lipid parameters included TC, LDL-c, HDL-c, TG and FFA. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. LDL-c and FFA were collected as part of the lipid panel and results were reviewed by investigators for individual participants. Change from Baseline at Week 10 and Week 26 was not assessed for these parameters. Analysis of these parameters was not a specific study objective and would not have any impact on study conclusions. Only those parameters with data values have been presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Baseline, Week 10 and Week 26|Safety Population.|||Millimoles per Liters||Standard Deviation|Mean
1323155|NCT02229227|Secondary|Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26|Urine samples were collected for analysis of leukocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of leukocytes in urine at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Participants|||Number
1323156|NCT02229227|Secondary|Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26|Urine samples were collected for analysis of erythrocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of erythrocytes in urine at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Participants|||Number
1323157|NCT02229227|Secondary|Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Safety Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Week 0 and Week 26|Safety Population.|||Participants|||Number
1323158|NCT02229227|Secondary|Mean Specific Gravity at Week 0 and Week 26|Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney’s ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Week 0 and Week 26|Safety Population.|||Ratio||Standard Deviation|Mean
1323159|NCT02229227|Secondary|Mean Creatinine at Week 0 and Week 26|Urine samples were collected for analysis of creatinine. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean creatinine at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Micromoles per Liter||Standard Deviation|Mean
1323160|NCT02229227|Secondary|Mean Albumin at Week 0 and Week 26|Urine samples were collected for analysis of albumin. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean albumin at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Milligrams per Liter||Standard Deviation|Mean
1323161|NCT02229227|Secondary|Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26|Urine samples were collected for analysis of albumin/creatinine ratio. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean urine albumin/creatinine ratio at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Grams per mole||Standard Deviation|Mean
1323173|NCT02229227|Secondary|Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26|Total number of weekly insulin injections (7 days) to achieve glycemic control at Baseline/Randomization and Week 4, 10, 18, and 26 are presented. Only those participants available at the specified time points were analyzed represented by n=X,X in category titles.|Baseline (Day -1) and Weeks 4, 10, 18 and 26|FA Population.|||Insulin Injections||Standard Deviation|Mean
1323162|NCT02229227|Secondary|Number of Participants With Clinical Chemistry Values of Clinical Concern|Clinical chemistry parameters and their potential clinical concern values were: albumin (>5 g/L above ULN or below LLN), alkaline phosphatase(>3 x ULN), alanine aminotransferase (>3 x ULN), aspartate aminotransferase (>3 x ULN), carbon dioxide content (<16 millimoles per Liter [mmol/L] and > 40 mmol/L), blood urea nitrogen (>2 x ULN), calcium (<1.8 mmol/L and >3.0 mmol/L), chloride (none), creatinine (>159 micromoles/Liter), direct bilirubin (>1.35 x ULN), gamma glutamyl transferase (>3 x ULN), glucose (fasting) (<3 mmol/L and >22 mmol/L), magnesium (<0.411 mmol/L and >1.644 mmol/L), phosphate (>0.323 mmol/L above ULN or below LLN), potassium (>0.5 mmol/L below LLN and >1.0 mmol/L above ULN), sodium (>5 mmol/L above ULN or below LLN), triglycerides (> 9.04 mmol/L), total bilirubin (>1.5 x ULN), total protein (>15 g/L above ULN or below LLN) and uric acid (>654 umol/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1323163|NCT02229227|Secondary|Number of Participants With Hematology Values of Clinical Concern|Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: Hematocrit >0.05 below lower limit of normal (LLN) and >0.04 above upper limit of normal (ULN), hemoglobin: >20 grams cells per Liter (g/L) below LLN and >10 g/L above ULN, lymphocytes: <0.5 x LLN, neutrophils: <1 giga cells per liter (GI/L), platelets: <80 GI/L and >500 GI/L, segmented neutrophils: <0.5 x LLN, RBC count: >1 GI/L below LLN and >5 GI/L above ULN and none for basophils, eosinophils, monocytes, neutrophil bands and RBC count. Only those parameters for which at least one value of potential clinical concern was reported are summarized.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1323164|NCT02229227|Secondary|Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms|Number of participants with hypoglycemia with blood glucose <56 mg/dL (<3.1 mmol/L), regardless of symptoms are presented.|Up to Week 26|Safety Population.|||Participants|||Number
1323165|NCT02229227|Secondary|Number of Participants With Daytime and Nocturnal Hypoglycemia|Daytime hypoglycemia was defined as hypoglycemic events with an onset between 06:00 hours and 00:00 hours (inclusive), and nocturnal hypoglycemia (in total and by category), defined as hypoglycemic events with an onset between 00:01 hours and 05:59 hours (inclusive). Number of participants with daytime and nocturnal hypoglycemia (in total and by category) are presented.|Up to Week 26|Safety Population.|||Participants|||Number
1323166|NCT02229227|Secondary|Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)|The American Diabetes Association has categorized hypoglycemic events as follows: Severe, documented symptomatic, asymptomatic, probably symptomatic and pseudohypoglycemia. Number of participants with hypoglycemic events in total are also presented.|Up to Week 26|Safety Population.|||Participants|||Number
1323167|NCT02229227|Secondary|Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26|Hypoglycemic events with confirmed home plasma glucose monitoring <3.9 millimoles per Liter and/or requiring third party intervention were severe, documented symptomatic (DS) and asymptomatic hypoglycemic events. Participants with more than one hypoglycemic event are counted in all categories reported. Any severe, documented symptomatic, and asymptomatic hypoglycemic events in 3-month intervals (i.e., from Day 0 to Week 12, >Week 12 to Week 26) are presented.|Up to Week 26|Safety Population.|||Percentage of participants|||Number
1323168|NCT02229227|Secondary|Number of Participants With Other AE of Special Interest|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a MP, whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. AE of special interest included hypoglycemic events, cardiovascular events, gastrointestinal events, injection site reactions, potential systemic allergic reactions, pancreatitis, pancreatic cancer, malignant neoplasms following treatment with insulin, diabetic retinopathy events, appendicitis, liver events, pneumonia, and atrial fibrillation/flutter.|Up to Week 26|Safety Population.|||Participants|||Number
1323169|NCT02229227|Secondary|Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication|AE is any untoward medical occurrence in a participant, temporally associated with use of medicinal product (MP), whether or not considered related to MP. AE can be any unfavorable, unintended sign (also an abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population: All participants who received at least 1 dose of randomized study medication. A participant randomized to Albiglutide + Insulin glargine by mistake received Insulin Lispro + Insulin Glargine instead. Since this participant received actual treatment as Insulin Lispro + Insulin Glargine, was summarized as such in Safety Population.|Up to Week 26|Safety Population.|||Participants|||Number
1323170|NCT02229227|Secondary|Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26|Percentage of participants achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia are presented.|Week 26|FA Population.|||Percentage of participants|||Number
1323171|NCT02229227|Secondary|Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26|Percentage of participants achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia are presented.|Week 26|FA Population.|||Percentage of participants|||Number
1323172|NCT02229227|Secondary|Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26|Percentage of participants achieving HbA1c <7.0% without weight gain are presented.|Week 26|FA Population.|||Percentage of participants|||Number
1323316|NCT02226198|Primary|LDL-Cholesterol (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH|||mmol/L||Standard Deviation|Mean
1323174|NCT02229227|Secondary|Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits|Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily bolus insulin (insulin lispro) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Weeks 4, 10, 18, and 26|FA Population.|||International Units||Standard Error|Least Squares Mean
1323175|NCT02229227|Secondary|Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits|Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily basal insulin (insulin glargine) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Weeks 4, 10, 18, and 26|FA Population.|||International Units||Standard Error|Least Squares Mean
1323176|NCT02229227|Secondary|Total Daily Insulin Dose at Week 4, Week 10 and Week 18|Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 4, Week 10 and Week 18 is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Weeks 4, 10, and 18|FA Population.|||International Units||Standard Error|Least Squares Mean
1323177|NCT02229227|Secondary|Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26|Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants meeting prespecified criteria for severe, persistent hyperglycemia up to Week 26 are presented.|Up to Week 26|FA Population.|||Participants|||Number
1323178|NCT02229227|Secondary|Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26|Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants who met prespecified criteria for severe, persistent hyperglycemia at Week 26 are presented.|Week 26|FA Population.|||Participants|||Number
1323179|NCT02229227|Secondary|Number of Participants Achieving a HbA1c <6.5% up to Week 26|Number of participants achieving a HbA1c <6.5% up to Week 26 are presented.|Up to Week 26|FA Population.|||Participants|||Number
1323180|NCT02229227|Secondary|Number of Participants Achieving a HbA1c <6.5% at Week 26|Number of participants achieving a HbA1c <6.5% at Week 26 are presented.|Week 26|FA Population.|||Participants|||Number
1323181|NCT02229227|Secondary|Number of Participants Achieving HbA1c <7.0% up to Week 26|HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% up to Week 26 are presented.|Up to Week 26|FA Population.|||Participants|||Number
1323182|NCT02229227|Secondary|Number of Participants Achieving HbA1c <7.0% at Week 26|HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% at Week 26 are presented.|Week 26|FA Population.|||Participants|||Number
1323183|NCT02229227|Secondary|Change From Baseline to Week 26 in FPG|FPG was measured at Baseline (Day -1) up to Week 26. FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the FSG values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline to Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
1323184|NCT02229227|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|FPG was measured at Baseline (Day -1). FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the fasting serum glucose (FSG) values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline and Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
1323185|NCT02229227|Secondary|Change From Baseline to Week 26 in HbA1c|HbA1c is glycosylated hemoglobin and was measured up to Week 26. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Baseline to Week 26|FA Population.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1323186|NCT02229227|Secondary|Total Daily Insulin Dose at Week 26|Insulin dose at Week 26 was defined as the prescribed insulin dose at Week 25. Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 26 is presented. Only those participants available at the specified time points were analyzed.|Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||International Units||Standard Error|Least Squares Mean
1324437|NCT02203630|Secondary|Mean Sequential Organ Failure Assessment (SOFA) Score|Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality|Up to 28 days|data was not collected||||||
1323187|NCT02229227|Secondary|Change From Baseline to Week 26 in Body Weight|Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Change from Baseline to Week 26 in body weight are presented. FA Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Baseline (Day -1) to Week 26|FA Population.|||Kilograms||Standard Error|Least Squares Mean
1323188|NCT02229227|Secondary|Change From Baseline in Body Weight at Week 26|Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline (Day -1) and Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
1323189|NCT02229227|Secondary|Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26|Severe hypoglycemia was considered as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 milligrams per deciliters (mg/dL) (<=3.9 millimoles per liters [mmol/L]).|Up to Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1323190|NCT02229227|Secondary|Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26|Participants who did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 were those participants treated with once-weekly albiglutide that were able to replace prandial insulin without lispro re-introduction through Week 26. Number of participants treated with once-weekly albiglutide that were able to discontinue insulin lispro at Week 4 and did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 have been presented.|Up to Week 26|FA Population.|||Participants|||Number
1323191|NCT02229227|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline (Day -1) and Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1323192|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment||||percent of participants|||Number
1323193|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment||Baseline, end of treatment||||percent of participants|||Number
1323194|NCT02229214|Secondary|Change in Cystatin C From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment cystatin C measurements.|||mg/L||Standard Error|Mean
1323195|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR"|Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after treatment iGFR measurements.|||mL/min/1.73 m^2||Standard Error|Mean
1323196|NCT02229214|Secondary|Change in Cystatin C From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment cystatin C measurements.|||mg/L||Standard Error|Mean
1323197|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment serum creatinine measurements.|||mg/dL||Standard Error|Mean
1323198|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment serum creatininine measurements|||mg/dL||Standard Error|Mean
1323199|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR."|Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment iGFR measurements.|||mL/min/1.73 m^2||Standard Error|Mean
1323214|NCT02228395|Secondary|Apparent Clearance (CL/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1323200|NCT02228980|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine|"Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).~Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever >39.5˚C; Crying abnormal - >3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)"|Day 0 up to Day 7 post any vaccination|Solicited injection site and systemic reactions were assessed in the Safety Population.|||Participants|||Number
1323201|NCT02228980|Other Pre-specified|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
1323202|NCT02228980|Other Pre-specified|Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
1323203|NCT02228980|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1323204|NCT02228720|Secondary|Sino-Nasal Outcome Test (SNOT) 22|Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110|Baseline, Day 30, Day 90|Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate|||units on a scale||Standard Deviation|Mean
1323205|NCT02228720|Secondary|Degree of Inflammation|Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia|||units on a scale|Sinuses|Standard Deviation|Mean
1323206|NCT02228720|Secondary|Adhesion/Scarring Grade 2 & 3|Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia|||percentage of evaluable sinuses|Sinuses||Number
1323207|NCT02228720|Secondary|Ostial Patency|Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia|||percentage of evaluable sinuses|Sinuses||Number
1323208|NCT02228720|Primary|Device Placement Success Rate|Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.|Baseline Procedure|Attempted frontal and maxillary sinus ostia|||Percentage of attempted sinuses|Sinuses||Number
1323209|NCT02228395|Secondary|Dose Normalized AUCinf (AUCinf[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1323210|NCT02228395|Secondary|Dose Normalized AUClast (AUClast[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1323211|NCT02228395|Secondary|Dose Normalized Cmax (Cmax[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||mg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1323212|NCT02228395|Secondary|Terminal Elimination Half-Life (t1/2)|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1323213|NCT02228395|Secondary|Apparent Volume of Distribution (Vz/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||liters||Geometric Coefficient of Variation|Geometric Mean
1324438|NCT02203630|Secondary|Number of Days Hemodialysis Needed||Up to 28 days|only participants that required dialysis|||days|||Number
1323215|NCT02228395|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1323216|NCT02228395|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1323217|NCT02228395|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hours||Full Range|Median
1323218|NCT02228395|Secondary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1323219|NCT02228395|Primary|Number of Participants With Abnormal Neurological Examination Findings|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA)|Baseline up to Day 10||||participants|||Number
1323220|NCT02228395|Primary|Number of Participants With Abnormal Physical Examination Findings|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 10||||participants|||Number
1323221|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.|||participants|||Number
1323222|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.|||participants|||Number
1323223|NCT02228395|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.|||participants|||Number
1323224|NCT02228395|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration.|The safety analysis population included all participants who received the study medication.|||participants|||Number
1323238|NCT02227485|Primary|Pocket Depth|It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||mm||Standard Deviation|Mean
1324439|NCT02203630|Secondary|Number of Days Mechanical Ventilation Needed||Up to 28 days|only participants that required mechanical ventilation|||days|||Number
1323225|NCT02228395|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline|The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.|||participants|||Number
1323226|NCT02227810|Secondary|Hospitalization Outcomes|The total days that participants stay in the respiratory care center (RCC).|the day participants were discharged from RCC|t test|||days||Standard Deviation|Mean
1323227|NCT02227810|Primary|Pulmonary Function|The pulmonary function as assessed by the measurement of tidal volume.|end of intervention|t -test|||ml||Standard Deviation|Mean
1323228|NCT02227810|Primary|Muscle Strength|The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.|end of intervention||||units on a scale||Standard Deviation|Mean
1323229|NCT02227810|Primary|Level of Activity of Daily Life|The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).|end of intervention||||units on a scale||Standard Deviation|Mean
1323230|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])|Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable Lp(a) data.|||percent||95% Confidence Interval|Median
1323231|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity|Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable cholesterol efflux capacity|||percent||95% Confidence Interval|Median
1323232|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)|Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable apoB data.|||percent||95% Confidence Interval|Median
1323233|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Non-HDL-C|Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.|Baseline, 3 Months|All randomized participants who had evaluable non-HDL-C data.|||percent||95% Confidence Interval|Median
1323234|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)|Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants with evaluable apoAI data.|||percent||95% Confidence Interval|Median
1323235|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)|Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.|Baseline, 3 Months|All randomized participants who had evaluable HDL-C data.|||percent||95% Confidence Interval|Median
1323236|NCT02227784|Primary|Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)|Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable LDL-C data|||percent||95% Confidence Interval|Median
1323237|NCT02227485|Primary|Modified Gingival Index|"0= Absence of inflammation~Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary~Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary~moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary~severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||units on a scale||Standard Deviation|Mean
1323239|NCT02227485|Secondary|Satisfaction of Patients|"We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.~This VAS ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:~Not satisfied at all~Not satisfied adequately~Not good-Not bad (So So)~Mostly Satisfied~Fully satisfied"|Up to 2 week||||participants|||Number
1323240|NCT02227485|Secondary|Number of Participants With Adverse Events||Up to 2 weeks||||participants|||Number
1323241|NCT02227485|Primary|Bleeding Index|"presence of bleeding of the gum when probing it: 0= No bleeding~1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||units on a scale||Standard Deviation|Mean
1323242|NCT02227485|Primary|Plaque Index|"0 No plaque~A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.~Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.~Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||units on a scale||Standard Deviation|Mean
1323243|NCT02227368|Secondary|Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET)||26 Weeks|ITT population is the analysis population. Twelve subjects without evaluable baseline were excluded from the analysis.|||log(Second)||95% Confidence Interval|Mean
1323244|NCT02227368|Primary|Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET)||26 Weeks|ITT population is the analysis population. Six subjects without evaluable baseline were excluded from the analysis.|||log(Second)||95% Confidence Interval|Mean
1323245|NCT02227329|Primary|Number of Catheter-Related Blood Stream Infections|The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and >1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.|1 year||||infections|||Number
1323246|NCT02227316|Secondary|Maximum Nausea Intensity|Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
1323247|NCT02227316|Secondary|Anti-Emetic Consumption|Mean dose of anti-emetic medication in milligrams given over 24 hours|24 hours||||Milligrams||Standard Deviation|Mean
1323248|NCT02227316|Secondary|Opioid Consumption|Mean opioid consumption in morphine equivalents over 24 hours|24 hours||||Morphine equivalent||Standard Deviation|Mean
1323249|NCT02227316|Secondary|Mean Nausea Intensity|Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
1323250|NCT02227316|Primary|Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen|Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
1323251|NCT02227316|Primary|Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen|Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
1323252|NCT02227121|Primary|Defibrillation Outcome|Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.|Day of procedure|Only subjects with ventricular fibrillation successfully induced were eligible for analysis|||Participants|||Count of Participants
1323253|NCT02227108|Secondary|Systemic Clearance (CL) After the First Dose of Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||milliliter per hour per kilogram||Full Range|Mean
1323254|NCT02227108|Secondary|Terminal Phase Elimination Half Life (t1/2) After the First Dose of Cycle 1|Terminal phase elimination half-life is the time measured for the serum/plasma concentration to decrease by one half, calculated as natural logarithmic (log)-transformed (ln) value of 2 divided by elimination rate constant (lambda); that is [ln(2)/lambda]. Elimination rate constant (lambda) was estimated via linear regression of the time versus log concentration.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||hour||Full Range|Median
1324440|NCT02203630|Secondary|Number of Direct Current (DC) Cardioversion Events||Up to 28 days||||DC cardioversion events|||Number
1323255|NCT02227108|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) After the First Dose of Cycle 1|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|Safety population who provided at least one measurable Pharmacokinetic concentration.|||hour||Standard Deviation|Mean
1323256|NCT02227108|Secondary|Maximum Observed Drug Concentration in Plasma (Cmax) After the First Dose of Cycle 1|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|Safety population who provided at least one measurable Pharmacokinetic concentration.|||nanogram per milliliter||Standard Deviation|Mean
1323257|NCT02227108|Secondary|Area Under the Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC0-last] After the First Dose of Cycle 1|AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC0-t is defined as AUC from time zero to the last data point above the lower limit of quantification.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
1323258|NCT02227108|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUC0-inf) After the First Dose of Cycle 1|AUC (0-infinity) = Area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (tinfinity). It was calculated by extrapolating the concentrationtime curve from time zero to infinity using the linear/log trapezoidal rule.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion of Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
1323259|NCT02227108|Secondary|Number of Participants With Positive Anti-drug Antibody (ADA) and Neutralizing Antibodies (NAb)|Immunogenicity assessment included determination of antidrug (moxetumomab pasudotox) antibodies and neutralizing antidrug antibodies in serum samples. Titers and specificity were determined for NAb-positive participants. Specificity were observed in participants who had ADAs directed to the PE38 domain of moxetumomab pasudotox and increase in titers were observed in participants who tested ADA-positive at baseline. Moxetumomab pasudotox ADA-titer is a validated immunoassay, which determines titers or levels of ADAs present in ADA-positive samples.|Prior to the Start of Each Cycle for Cycles 1, 2, 3, and Subsequent Odd-Numbered Cycles, End of Treatment, and 30 Day Follow-up Visit, up to 1 year|"Safety population includes all participants who received any amount of moxetumomab pasudotox. Here, number of participants analysed, N included participants with at least one post-baseline sample."|||participants|||Number
1323260|NCT02227108|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Participants who experienced vital signs abnormalities recorded as TEAEs were reported.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
1323261|NCT02227108|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Participants were evaluated for ECG abnormalities.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
1323262|NCT02227108|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAE)|Laboratory tests were grouped according to hematology, serum chemistry, and urinalysis. Laboratory abnormalities with toxicity grades according to NCI CTCAE Version 4.03 were derived according to laboratory values and reported as treatment-emergent adverse events.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
1323263|NCT02227108|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Treatment-emergent adverse events (TEAEs), were defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
1323264|NCT02227108|Secondary|Overall Survival (OS)|OS was determined as the time from the start of treatment with moxetumomab pasudotox until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.|Baseline to end of study or last contact date, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||Full Range|Median
1323265|NCT02227108|Secondary|Progression-Free Survival (PFS)|PFS was measured from the start of treatment with moxetumomab pasudotox until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||Full Range|Median
1323266|NCT02227108|Secondary|Duration of Overall Response (DOR)|DOR was to be defined as the duration from the first documentation of overall response to the first documented disease progression. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||Full Range|Median
1323267|NCT02227108|Secondary|Duration of Complete Response (DOCR)|DOCR was defined as the duration from the first documentation of CRc to the first documented disease progression.The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|"Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||months|||Number
1323268|NCT02227108|Secondary|Percentage of Participants Who Were Neutropenic at Study Entry and Who Experienced Hematologic Activity (HA)|The percentage of participants who were neutropenic at study entry and experienced HA after treatment with moxetumomab pasudotox was evaluated. The Clopper Pearson (Exact) 95% CI was calculated.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
1323269|NCT02227108|Secondary|Time to Transplant to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox|The time to SCT was defined as the duration from the start of treatment with moxetumomab pasudotox until the date when the subject became eligible for SCT. The time to SCT was to be summarized using the Kaplan-Meier method, and was only to be evaluated for the subgroup of subjects who became eligible for SCT after treatment with moxetumomab pasudotox.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy population included participants who received moxetumomab pasudotox, completed a baseline disease assessment and had at least one post-baseline assessment. Since study was terminated prematurely, no participant received SCT after treatment with moxetumomab pasudotox, hence data were not collected for this Outcome measure.||||||
1323270|NCT02227108|Secondary|Percentage of Participants Who Became Eligible to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox|The percentage of participants who became eligible for SCT after treatment with moxetumomab pasudotox were provided. The Clopper Pearson (Exact) 95% CI was calculated.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
1323271|NCT02227108|Secondary|Bone Marrow Blast Percentage Change|Change in bone marrow blast percentage from baseline was evaluated. If the percentage (%) blasts (at least 200 cells counted) is less than (<) 5%, it is considered as M1, 5 to 25% considered as M2, greater than (>) 25% considered as M3. Stages with the higher blasts relate to worse outcomes.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|"The intent to treat (ITT) population included all participants who entered the study. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||percentage of participants|||Number
1323272|NCT02227108|Secondary|Best Overall Response (BOR)|The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number and percentage of participants for the following categories: CRc, PR, HA, SD, PD, and not evaluable. Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes and in size of liver or spleen. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
1323273|NCT02227108|Secondary|Time to Overall Response|Time to overall response was evaluated using the Kaplan-Meier method.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||95% Confidence Interval|Median
1323274|NCT02227108|Secondary|Overall Response Rate (ORR)|The ORR, defined as the percentage of participants with CRc or partial response (PR), was estimated; the Clopper Pearson (Exact) 95% CI was calculated. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1323283|NCT02226549|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants|||Number
1323284|NCT02226549|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1324441|NCT02203630|Secondary|Use of Corticosteroid|number of days participants received a corticosteroid|Up to 28 days||||days|||Number
1323275|NCT02227108|Secondary|Percentage of Participants With Minimal Residual Disease (MRD)-Negative CRc Rate|The MRD-negative CRc rate was defined as the percentage of participants who achieved CRc and became MRD-negative as determined by flow cytometry performed by a central analysis laboratory. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
1323276|NCT02227108|Primary|Percentage of Participants With Composite Complete Response (CRc)|The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts. The efficacy assessments were evaluated as per investigator assessment.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1323277|NCT02226562|Secondary|Mean Change From Baseline in VRS at Week 4|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Deviation|Mean
1323278|NCT02226562|Secondary|Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Deviation|Mean
1323279|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Gram (g)||Standard Deviation|Mean
1323280|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Gram(g)||Standard Deviation|Mean
1323281|NCT02226562|Secondary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Scores on scale||Standard Deviation|Mean
1323282|NCT02226562|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
1324442|NCT02203630|Secondary|Number of Times an Anti-arrhythmic Agent is Used||Up to 28 days||||events|||Number
1323285|NCT02226549|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1323286|NCT02226198|Secondary|Abnormal Vital Signs|Safety and tolerability will be described in terms of abnormal vital signs|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||participants|||Number
1323287|NCT02226198|Secondary|Physical Exam Abnormalitites|Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.|Screening, Week 0, week 6, week 12 and week 18, week 24||||participants|||Number
1323288|NCT02226198|Secondary|ECG Abnormalities|Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)|Week 0||||participants|||Number
1323289|NCT02226198|Secondary|Urinalysis Abnormalitites|Safety and tolerability will be described in terms of abnormal urine laboratory values|Week 0, week 6, week 12 and week 18||||participants|||Number
1323290|NCT02226198|Secondary|ApoB/ApoA|Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
1323291|NCT02226198|Secondary|Non-HDL C/HDL C|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
1323292|NCT02226198|Secondary|TC/HDL C|Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
1323293|NCT02226198|Secondary|LDL C/HDL C|Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
1323294|NCT02226198|Secondary|TG (mmol/L)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
1323295|NCT02226198|Secondary|TG (mg/dL)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
1323296|NCT02226198|Secondary|Tanner Stage|"Stages for fem (Pubic hair, Breasts):~(Preadol,Preadol)~(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)~(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)~(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)~(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)~1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred."|Week 0 (start of cross-over)||||stage||Standard Deviation|Mean
1323297|NCT02226198|Secondary|Weight|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18||||kg||Standard Deviation|Mean
1323298|NCT02226198|Secondary|Height Z-score|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18||||ratio||Standard Deviation|Mean
1323299|NCT02226198|Secondary|Height|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18||||cm||Standard Deviation|Mean
1323300|NCT02226198|Secondary|Abnormal Serum Levels|Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||participants|||Number
1323301|NCT02226198|Secondary|AE's Leading to Discontinuation|Safety and tolerability will be described in terms of rate of discontinuations due to adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||adverse events|||Number
1323302|NCT02226198|Secondary|Adverse Events|Safety and tolerability will be described in terms of frequency and severity of adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||adverse events|||Number
1323303|NCT02226198|Secondary|Trough Concentrations|Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.|Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)||||ng/mL||Standard Deviation|Mean
1323304|NCT02226198|Secondary|LDL-C From End of Placebo (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)||||mmol/L||Standard Deviation|Mean
1323305|NCT02226198|Secondary|LDL-C From End of Placebo (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)||||mg/dL||Standard Deviation|Mean
1323306|NCT02226198|Secondary|LDL-C, Not on Apheresis (mmol/L)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis|||mmol/L||Standard Deviation|Mean
1323307|NCT02226198|Secondary|LDL-C, Not on Apheresis (mg/dL)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis|||mg/dL||Standard Deviation|Mean
1323317|NCT02226198|Primary|LDL-Cholesterol (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH|||mg/dL||Standard Deviation|Mean
1323318|NCT02226172|Secondary|Psychometric Validation of the MPN-SAD in the Randomised Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
1323319|NCT02226172|Secondary|Glasdegib PK Parameters in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Cycle 1, Day 15|PK Parameter Analysis Population||||||
1323320|NCT02226172|Secondary|Kaplan-Meier Estimate of Overall Survival in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
1323321|NCT02226172|Secondary|Median Duration of SVR in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
1323322|NCT02226172|Secondary|Participant Reported Outcomes of Health Related Quality of Life and Health Status in the Randomised Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
1323323|NCT02226172|Secondary|Percentage of Participants Achieving Anemia Response (Transfusion Dependent Versus Independent) in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
1323324|NCT02226172|Secondary|Monthly Mean Change From Baseline in Overall TSS in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Weeks 12, 24, 36 and 48|FAS||||||
1323325|NCT02226172|Secondary|Percentage of Participants Achieving SVR ≥50% as Measured by MRI/CT Scan at Week 24 in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Week 24|FAS||||||
1323326|NCT02226172|Secondary|Time to Reach Cmax (Tmax) in the Lead-in Cohort|Tmax was the time of the first occurrence of Cmax observed directly from the plasma concentration data.|Cycle 1, Day 15|PK Parameter Analysis Population|||Hours||Full Range|Median
1323327|NCT02226172|Secondary|Area Under the Glasdegib Plasma Concentration Versus Time Profile at the End of a Dosing Interval (AUCtau) in the Lead-in Cohort|AUCtau was the area under the glasdegib plasma concentration-time profile from time zero to the end of the dosing interval (24 hours) estimated by non-compartmental PK analysis using the linear/log trapezoidal method.|Cycle 1, Day 15|PK Parameter Analysis Population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1323328|NCT02226172|Secondary|Maximum Observed Glasdegib Plasma Concentration (Cmax), Minimum Glasdegib Plasma Concentration Observed Prior to the Next Dose (Cmin), and Average Observed Glasdegib Plasma Concentration (Cavg) in the Lead-in Cohort|Cmax was the highest plasma concentration of glasdegib observed directly from the plasma concentration data. Cmin was the lowest plasma concentration of glasdegib observed directly from the plasma concentration data. Cavg was the average concentration at steady state estimated using non-compartmental pharmacokinetic (PK) analysis.|Cycle 1, Day 15|PK Parameter Analysis Population - included all enrolled participants treated who had at least 1 of the PK parameters of interest and were dose compliant (at steady state for glasdegib ).|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1323329|NCT02226172|Secondary|Percentage of Participants Achieving Anemia Response (Transfusion Dependent Versus Independent) in the Lead-in Cohort|Anemia response was defined as transfusion-independent participants with a ≥20 gram per liter (g/L) increase in hemoglobin (Hb) level where baseline Hb level was <100 g/L, or baseline transfusion-dependent patients becoming transfusion-independent post-baseline. Transfusion dependency before the start of study treatment was defined as transfusions of ≥6 units of packed red blood cells in the 12 weeks prior to start of study treatment, for a final pre-treatment Hb of <85 g/L. In addition, the most recent transfusion episode must have occurred in the 28 days prior to study enrollment. Response in transfusion-dependent patients required absence of any packed red blood cell transfusions during any consecutive rolling 12-week interval during the treatment phase, capped by a Hb level of ≥85 g/L.|Baseline to end of treatment|Lead-in Analysis Set|||Percentage of participants|||Number
1323330|NCT02226172|Secondary|Monthly Mean Change From Baseline in Overall Total Symptom Score (TSS) in the Lead-in Cohort|The MPN-SAD assessed the impact of 9 myelofibrosis symptoms, at their worst, over the past 7 days and over the past 24 hours on a scale of 0 (absent) to 10 (worst imaginable). The 9 symptoms are early satiety, abdominal discomfort, inactivity, night sweats, pruritus, bone pain, pain below the ribs on the left-hand side, fatigue and shortness of breath. The TSS is the sum of the individual scores, excluding inactivity and shortness of breath. The TSS at Week 24 is the average of the daily total scores from the last 28 days of symptom scores immediately prior to Week 24. A higher score indicates worse symptoms.|Weeks 12, 24, 36 and 48|Lead-in Analysis Set|||Score on a scale||Standard Deviation|Mean
1323331|NCT02226172|Secondary|Percentage of Participants Achieving ≥50% Reduction From Baseline in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm-Symptom Assessment Diary (MPN-SAD) at Week 24 in the Lead-in Cohort|The MPN-SAD assessed the impact of 9 myelofibrosis symptoms, at their worst, over the past 7 days and over the past 24 hours on a scale of 0 (absent) to 10 (worst imaginable). The 9 symptoms are early satiety, abdominal discomfort, inactivity, night sweats, pruritus, bone pain, pain below the ribs on the left-hand side, fatigue and shortness of breath. The TSS is the sum of the individual scores, excluding inactivity and shortness of breath. The TSS at Week 24 is the average of the daily total scores from the last 28 days of symptom scores immediately prior to Week 24. A higher score indicates worse symptoms.|Week 24|Lead-in Analysis Set|||Percentage of participants|||Number
1324443|NCT02203630|Secondary|Number of Uses of Rate-controlling Agent|includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil|Up to 28 days||||number of uses|||Number
1323332|NCT02226172|Secondary|Percentage of Participants Achieving SVR ≥35% as Measured by Magnetic Resonance Imaging/Computed Tomography Scan at Week 24 in the Lead-in Cohort|MRI (CT scan may have been permitted if MRI was contraindicated) of the spleen and the liver was performed at baseline, then every 12 weeks while the participant was on treatment. The same method of assessment used at baseline was used for the duration of the trial to ensure consistency. Spleen volume was assessed by a central, independent blinded reader.|Week 24|Lead-in Analysis Set - included all participants treated in the lead-in portion of the study. Only participants who remained on treatment at Week 24 underwent MRI/CT scan.|||Percentage of participants|||Number
1323333|NCT02226172|Primary|Percentage of Participants Achieving Spleen Volume Reduction (SVR) ≥35% as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) Scan at Week 24 in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Week 24|Full Analysis Set (FAS) - included all participants in the randomized Phase 2 component of the study who were randomized with study drug assignment designated according to initial randomization.||||||
1323334|NCT02226003|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.|||millimeters of mercury||95% Confidence Interval|Least Squares Mean
1323335|NCT02226003|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.|||millimeters of mercury||95% Confidence Interval|Least Squares Mean
1323336|NCT02226003|Secondary|Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach|Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.|||Kilograms||95% Confidence Interval|Least Squares Mean
1323337|NCT02226003|Secondary|Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.|Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.|||Percentage of participants|||Number
1323338|NCT02226003|Secondary|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach|Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.|||milligrams/deciliter||95% Confidence Interval|Least Squares Mean
1323339|NCT02226003|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.|||milligrams/deciliter||95% Confidence Interval|Least Squares Mean
1323340|NCT02226003|Primary|Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Up to Week 26|ASaT population consisted of all randomized participants who received at least one dose of a study drug.|||Percentage of Participants|||Number
1323341|NCT02226003|Primary|Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Up to Week 28|All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.|||Percentage of Participants|||Number
1323342|NCT02226003|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.|||Percentage||95% Confidence Interval|Least Squares Mean
1323343|NCT02225860|Secondary|Change in Mean Serum Copeptin Level From Baseline to Week 1|Mean serum copeptin level at week one which will reflect the effect of low osmolar diet alone.|baseline to week 1|At week 1, there was a nonsignificant (t-test) increase in plasma copeptin to 7.1 ±5.6 in the low osmolar diet group and to 6.1 ±5.5 in the control group. The change in mean plasma copeptin level between baseline and week1 was not statistically significant between groups.|||pmol/L||Standard Deviation|Mean
1323344|NCT02225860|Secondary|Change in Total Daily Urinary Solutes From Baseline to Week 2|"Total daily urinary solutes (this will serve as a surrogate for diet adherence and is known to be associated with lower vasopressin secretion).~Total daily solutes is the total amount of osmoles detected in 24 hours urine collection."|Baseline to week 2||||mOsm/Day||Standard Deviation|Mean
1323345|NCT02225860|Primary|Change in Mean Serum Copeptin From Baseline (a Reflection of Endogenous Vasopressin Production) at Week 2|The copeptin level will reflect the combined effect of low osmolar diet and adjusted water intake at week 2|Baseline to week 2||||pmole/L||Standard Deviation|Mean
1323346|NCT02225080|Secondary|Occurence of Adverse Event|Adverse event that occured between days 21-30 post-operatively|Between days 21-30|||||||
1323347|NCT02225080|Secondary|Occurence of Adverse Event|Adverse event that occured between days 7-14 post-operatively|between days 7-14|||||||
1323348|NCT02225080|Secondary|Occurence of Adverse Event|Adverse event that occured 72 hours post-operatively|first 72 hours post-op|||||||
1323349|NCT02225080|Secondary|Occurrence of Adverse Events||Day 30|||||||
1323350|NCT02225080|Primary|Patient's Outcome|Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)|Day 30||||Participants|||Count of Participants
1323351|NCT02224846|Secondary|"Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2"|"Participants with “yes” responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.~GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?"|Month 3, Month12, Month 24|All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2.|||percentage of participants|||Number
1323352|NCT02224846|Secondary|Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments|Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.|Month 6, Month 12, Month 18, Month 24|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||Percentage of participants|||Number
1323353|NCT02224846|Secondary|Percentage of Participants Achieving Normal Erectile Functioning|Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.|Month 1, Month 3|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||Percentage of partcipants|||Number
1323354|NCT02224846|Secondary|"Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary"|Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.|Month 1, Month 3|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||Percentage of participants||Standard Deviation|Mean
1323355|NCT02224846|Secondary|Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments|IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.|Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24|All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||units on a scale||Standard Error|Least Squares Mean
1323356|NCT02224846|Secondary|Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score|IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.|Baseline, Month 1; Baseline, Month 3|All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||units on a scale||Standard Error|Least Squares Mean
1323599|NCT02220920|Secondary|Percent Change in Body Weight||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of body weight at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."|||percent change||Standard Error|Least Squares Mean
1323357|NCT02224846|Primary|Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation|Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through Month 12|All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.|||percentage of participants|||Number
1323358|NCT02224846|Primary|Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through Month 12|All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.|||Percentage of participants|||Number
1323359|NCT02224820|Secondary|Pharmacokinetics|IdeS T1/2 in alpha phase. One patient who interrupted dose was excluded.|Up to 21 days||||h||Inter-Quartile Range|Mean
1323360|NCT02224820|Secondary|Immunogenicity|Presence of Anti-Drug Antibodies formation in serum throughout a 64 day period|Up to 64 days||||participants|||Number
1323361|NCT02224820|Secondary|Pharmacodynamics|IgG cleavage and regeneration measured by ELISA|Up to day 64||||µg/mL||Standard Deviation|Mean
1323362|NCT02224820|Secondary|Safety|Adverse events (all clinical laboratory tests, vital signs and ECG jugded as clinically significant were reported as AEs)|9 weeks||||Adverse events|||Number
1323363|NCT02224820|Primary|Efficacy|Efficacy was defined as the IdeS dosing scheme in the majority of the patients resulting in human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as mean fluorescent intensity (MFI) of less than 1100, within 24 hours from dosing. MFI was determined by single antigen bead (SAB) assay and detection of complement fixating ability (CIq Screen) in serum.|24 hours||||MFI||Inter-Quartile Range|Mean
1323364|NCT02224729|Secondary|Count of Participants That Experience Overall Survival (OS)|The amount of participants that start treatment with BBd and survive at least one year post treatment completion.|1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
1323365|NCT02224729|Secondary|Count of Participants That Experience Progression-free Survival (PFS)|The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.|1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
1323366|NCT02224729|Secondary|Count of Participants That Experience Very Good Partial Remission (VGPR)|Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and >90% reduction of M-protein in serum and urine|Up to 1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
1323367|NCT02224729|Secondary|Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0|All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.|Up to 1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Adverse Events|||Number
1323368|NCT02224729|Primary|Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd|ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.|At least 140 days|4 subjects were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
1323369|NCT02224690|Secondary|Subject/Caregiver Global Impression Of Change Assessment (S/CGIC)|The S/CGIC was used to assess the participant’s overall condition on a 7-point scale, using the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse” (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant’s overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant’s last evaluation was performed.|Baseline to Last Visit (Day 99) or ET|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
1323370|NCT02224690|Secondary|Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period|Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
1323422|NCT02223871|Secondary|Change From Baseline in Blood Pressure to End of Study (EOS)|Vital signs, including diastolic and systolic blood pressure (DBP/SBP), were measured at each outpatient visit up to 7 days after ACT-451840 administration, every day during confinement or when malaria symptoms were presented and at the end of study visit (EOS). Other measures were performed if required.|Day 28 (EOS)||||mmHg||Full Range|Median
1323371|NCT02224690|Secondary|Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
1323372|NCT02224690|Primary|Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: (frequency during the treatment period - frequency during baseline/frequency during baseline) * 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) *28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline.|Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
1323373|NCT02224664|Secondary|Ratio of Accumulation for Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751|Rac was obtained from AUCtau after last dose divided by AUCtau after first dose, where AUC(tau) = Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.|Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|Data was not collected since this outcome measure was not planned to be analyzed.||||||
1323374|NCT02224664|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reporting arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1323375|NCT02224664|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751|Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.|Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reporting arm, respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1323376|NCT02224664|Secondary|Apparent Clearance (CL/F) of PF-06649751|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1323377|NCT02224664|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reprting arm, respectively.|||hour||Full Range|Median
1323378|NCT02224664|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time points for each reporting arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1323379|NCT02224664|Secondary|Apparent Volume of Distribution (Vz/F) of L-Dopa|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
1323380|NCT02224664|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of L-Dopa|Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (C last).|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1323381|NCT02224664|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time of L-Dopa|AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1323382|NCT02224664|Secondary|Terminal Half-Life (t1/2) of L-Dopa|Terminal half-life is the time measured for the plasma concentration of drug to decrease by one half. It was calculated as dividing the natural logarithm to the base e (Log e)*2/k el, where k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
1323383|NCT02224664|Secondary|Apparent Clearance (CL/F) of L-Dopa|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1323384|NCT02224664|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of L-Dopa||Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1323385|NCT02224664|Secondary|Maximum Observed Plasma Concentration (Cmax) of L-Dopa||Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa pharmacokinetic (PK) parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1323386|NCT02224664|Primary|Change From Baseline in Parkinson’s Disease Diary For Participants With Motor Fluctuations at Day 20|According to Parkinson’s disease diaries of participants “OFF” time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. “ON” time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. “ON” time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. “OFF” time and “ON” time with TD were generally considered to be “bad time” with regard to motor function, whereas “ON” time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be “good time”.|Baseline, Day 20|Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,‘n’ signifies those participants who were evaluable at specified time points for each reporting arm. This outcome measure was not planned to be assessed in lead-in period (L-dopa).|||hour||Standard Deviation|Mean
1323387|NCT02224664|Primary|Change From Baseline in Parkinson’s Disease Diary For Participants With Motor Fluctuations at Day 13|According to Parkinson’s disease diaries of participants “OFF” time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. “ON” time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. “ON” time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. “OFF” time and “ON” time with TD were generally considered to be “bad time” with regard to motor function, whereas “ON” time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be “good time”.|Baseline, Day 13|Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,‘n’ signifies those participants who were evaluable at specified time points for each reporting arm.This outcome measure was not planned to be assessed in lead-in period (L-dopa).|||hour||Standard Deviation|Mean
1323388|NCT02224664|Primary|Number of Participants With Categorical Scores on The Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of “yes” on “actual attempt”), 3: preparatory acts toward imminent suicidal behavior (“yes” on “aborted attempt”, “interrupted attempt”, “preparatory acts or behavior”), 4: any suicidal behavior or ideation, suicidal ideation (“yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent”), 7: self-injurious behavior, no suicidal intent (“yes” on “has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 2. This outcome measure was not planned to be assessed in lead-in period (L-dopa).|||participants|||Number
1323389|NCT02224664|Primary|Number of Participants With Clinically Significant Neurological Examination Abnormality|The complete or full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. Findings were considered abnormal as confirmed by a certified neurologist.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.|||participants|||Number
1323390|NCT02224664|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings|Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator’s decision.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.|||participants|||Number
1323391|NCT02224664|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia’s Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1323392|NCT02224664|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for vital sign abnormality included supine pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, supine and standing SBP of >=30 mmHg maximum (max.) increase from baseline (IFB) and and decrease from baseline (DFB) in same posture, supine and Standing DBP of >=20 mmHg max. increase and decrease from baseline in same posture. Categories in which there was atleast 1 abnormality are reported in this outcome measure.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, ‘n’ signifies the number of participants evaluable for the specific category.|||participants|||Number
1323393|NCT02224664|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb),hematocrit, red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN),mean corpuscular Hgb, mean corpuscular volume, mean corpuscular Hgb concentration:<0.9*LLN, greater than (>)1.1*upper limit of normal(ULN),platelet:<0.5*LLN,>1.75*ULN,lymphocyte,neutrophil:<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN, WBC:<0.6*LLN, >1.5*ULN;total bilirubin>1.5*ULN, aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase:>3.0*ULN,total protein,albumin:<0.8*LLN,>1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN, uric acid>1.2*ULN;sodium<0.95*LLN,>1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN,>1.1*ULN;glucose<0.6*LLN,>1.5*ULN,urine pH:<4.5, >8; urine: WBC, RBC greater than or equal to (>=)20/high performance field, bacteria: >20; urobilinogen, urine: glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin: >=1.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1323394|NCT02224664|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (up to Day 30) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.|||participants|||Number
1323395|NCT02224625|Primary|Grading Scale for Visual Evaluation of Skin Condition|"Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.~Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.~Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading"|21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)|Participants received more than one product at a time.|||Scores Ranging (0-7)||Full Range|Mean
1323396|NCT02224560|Secondary|Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment|The S/CGIC was used to assess the participant’s overall condition on a 7-point scale, using the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse” (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant’s last evaluation was performed.|Baseline to Last Visit (Day 99) or ET|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
1323397|NCT02224560|Secondary|Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period|Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
1323398|NCT02224560|Secondary|Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic, or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
1323399|NCT02224560|Primary|Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline.|Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
1323400|NCT02224508|Secondary|Depressive Symptoms|Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|2 weeks prior to interview||||units on a scale||95% Confidence Interval|Mean
1323401|NCT02224508|Secondary|Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale|PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|1 week prior to interview||||units on a scale||95% Confidence Interval|Mean
1323402|NCT02224508|Primary|Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).|Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|1 year prior to interview|Prevalent chronic opioid therapy (COT) patients defined as having received at least 70 days supply of opioids in the 90 days prior to sample selection, at least 70 days supply of opioids in at least one of the 3 other quarters in the preceding year, and at least 45 days supply of opioids in the other two quarters.|||proportion of COT patients||95% Confidence Interval|Number
1323403|NCT02224404|Secondary|Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance|Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm|6 weeks||||units on a scale||Inter-Quartile Range|Median
1323404|NCT02224404|Primary|Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)|the subjects will be measured by the following variables; maceration,|6 weeks||||participants|||Number
1323405|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 AUC|Assessment of the PK of AZ5104 and AZ7550 AUC using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Ratio||Full Range|Geometric Mean
1323406|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 Cmax|Assessment of the PK of AZ5104 and AZ7550 Cmax using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Ratio||Full Range|Geometric Mean
1323407|NCT02224053|Secondary|AUC of AZ5104 and AZ7550|Area under the plasma concentration-time curve from zero to infinity of AZ5104 and AZ7550 (metabolites to AZD9291)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
1323408|NCT02224053|Secondary|Cmax of AZ5104 and AZ7550|Assessment of the PK of AZ5104 and AZ7550 (metabolites to AZD9291) using the maximum plasma concentration, Cmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM||Full Range|Geometric Mean
1323423|NCT02223871|Secondary|Terminal Half-life [t(1/2)]|Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose|From pre-dose to144 hours after study drug adminsitration|Per protocol set|||Hours||95% Confidence Interval|Geometric Mean
1323409|NCT02224053|Secondary|Vz/F of AZD9291|Assessment of the PK of AZD9291 using the apparent volume of distribution, Vz/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L||Full Range|Geometric Mean
1323410|NCT02224053|Secondary|CL/F of AZD9291|Assessment of the PK of AZD9291 using the apparent plasma clearance, CL/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L/h||Full Range|Geometric Mean
1323411|NCT02224053|Secondary|λz|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal rate constant, λz|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||1/h||Full Range|Geometric Mean
1323412|NCT02224053|Secondary|t(1/2)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal half-life, t(1/2)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||h||Full Range|Geometric Mean
1323413|NCT02224053|Secondary|Tlag|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using lag time before observation of quantifiable analyte concentrations in plasma, tlag|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||h||Full Range|Median
1323414|NCT02224053|Secondary|Tmax|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using time to reach maximum plasma concentration, tmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||h||Full Range|Median
1323415|NCT02224053|Secondary|AUC(0-72)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from time zero to 72 hours, AUC(0-72)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
1323416|NCT02224053|Secondary|AUC(0-t)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from zero extrapolated to o the time of the last quantifiable concentration, AUC(0-t)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
1323417|NCT02224053|Primary|Cmax of AZD9291|Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma concentration (Cmax).|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM||Full Range|Geometric Mean
1323418|NCT02224053|Primary|AUC of AZD9291|Area under the plasma concentration-time curve from zero to infinity for AZD9291|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
1323419|NCT02223871|Post-Hoc|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a New Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated following the data-driven method by Marquart et al. (2015), removing potential lag and tail phases prior to log-linear regression modeling."|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 8 with the method described by Marquart et al., 2015)|||Ratio||95% Confidence Interval|Mean
1323420|NCT02223871|Secondary|Change From Baseline in Respiratory Rate to End of Study (EOS)||Day 28 (EOS)||||Breaths/min||Full Range|Median
1323421|NCT02223871|Secondary|Change From Baseline in Body Temperature up to End of Study (EOS)|Body temperature was measured orally|Day 28 (EOS)||||Degree Celsius||Full Range|Median
1325490|NCT02181127|Secondary|Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl||2 weeks|||||||
1323424|NCT02223871|Secondary|Areas Under the Plasma Concentration-time Curve of ACT-451840|"Two AUCs were calculated using non-compartmental analysis: AUC(0-t) from pre-dose to last time-point of measure and AUC(0-inf) from pre-dose and extrapolated to infinity.~Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose"|From pre-dose to144 hours after study drug administration||||ng*h/mL||95% Confidence Interval|Geometric Mean
1323425|NCT02223871|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840|tmax was directly derived from the plasma concentration-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to144 hours after study drug administration||||Hours||Full Range|Median
1323426|NCT02223871|Secondary|Maximum Plasma Concentration (Cmax) of ACT-451840|Cmax was directly derived from the plasma concentrations-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to 144 hours after study drug adminsitration||||ng/mL||95% Confidence Interval|Geometric Mean
1323427|NCT02223871|Primary|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated using an objective standardized approach (observed data over 48 h)"|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 5)|||Ratio||95% Confidence Interval|Mean
1323428|NCT02223754|Primary|Contact Lens Fitting|Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percentage of Subject Eyes|Subject Eyes||Number
1323429|NCT02223754|Primary|Limbal Conjunctival Injection|The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percentage of Subject Eyes|Subject Eyes||Number
1323430|NCT02223754|Primary|Bulbar Conjunctival Injection|The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percentage of Subject Eyes|Subject Eyes||Number
1323431|NCT02223754|Primary|Corneal Staining|Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject’s inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8 - 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||percentage of Subject Eyes|Subject Eyes||Number
1323432|NCT02223754|Primary|Near Binocular Visual Acuity (LogMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
1323433|NCT02223754|Primary|Intermediate Binocular Visual Acuity (LogMAR)|Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
1323434|NCT02223754|Primary|Distance Binocular Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.|8- 12 Days post wear|The analysis population consists of subjects that have completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
1323435|NCT02223754|Primary|Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8 -12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
1323436|NCT02223715|Secondary|Recurrence or Not After 2 Months Follow-up|"The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment.~Unknown includes patient lost, data missing"|From the time of CDI diagnosis to 2 months follow-up||||participants|||Number
1325491|NCT02181127|Secondary|Percentage of Study Days With Mean BG < 154 mg/dl||2 weeks|||||||
1325492|NCT02181127|Secondary|Percentage of All BG Values Less Than 70 mg/dl||2 weeks|||||||
1323437|NCT02223715|Secondary|Clinical Complication|This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected.|From the time of CDI diagnosis to recovery or recurrence||||participants|||Number
1323438|NCT02223715|Primary|Status at the End of CDI Episode|The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.|From the time of CDI diagnosis to the end of the treatment||||participants|||Number
1323439|NCT02223715|Primary|Patient Demographics|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.|At the study at the time of CDI diagnosis enrollment|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.|||participants|||Number
1323440|NCT02223650|Secondary|Proportion of Subjects With Near Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks||||participants|||Number
1323441|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks||||participants|||Number
1323442|NCT02223650|Secondary|Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).|||participants|||Number
1323443|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks||||participants|||Number
1323444|NCT02223650|Secondary|Binocular Near Visual Acuity|Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.|8 weeks||||prism diopters||Standard Deviation|Mean
1323445|NCT02223650|Secondary|Distance Visual Acuity|Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance|8 weeks||||prism diopters||Standard Deviation|Mean
1323446|NCT02223650|Secondary|Stereoacuity|Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.|8 weeks||||log arcsecond||Standard Deviation|Mean
1323447|NCT02223650|Secondary|Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).|||participants|||Number
1323448|NCT02223650|Secondary|Proportion of Subjects With Distance Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks||||participants|||Number
1323449|NCT02223650|Secondary|Distribution of Near Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks||||participants|||Number
1323450|NCT02223650|Secondary|Distribution of Distance Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks||||participants|||Number
1323451|NCT02223650|Secondary|Mean Near Exotropia Control Score|"At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a triple control score, which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control."|8 weeks||||points on control score scale||Standard Deviation|Mean
1323452|NCT02223650|Primary|Mean Distance Exotropia Control Score|"At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a “triple control score,” which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.~*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50."|8 weeks||||points on control score scale||Standard Deviation|Mean
1323453|NCT02223429|Secondary|Mean Percent Signal Change in Right Lateral Septum|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between AVP treatment and placebo treatments (AVP-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the AVP group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was conducted in the AVP groups only per protocol. One person from each order of administration were excluded from the analysis due to motion issues in their imaging data.|||Percent signal change||Standard Deviation|Mean
1323454|NCT02223429|Secondary|Mean Percent Signal Change in Primary Auditory Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo group only.|||Percent signal change||Standard Deviation|Mean
1323455|NCT02223429|Secondary|Difference in Cry Rating Scores Between AVP and Placebo|"The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under AVP and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents not at all and 7 represents extremely. Difference is defined as AVP minus placebo scores."|Baseline, Visit 2 (Up to 10 days)|Analysis was completed according to protocol for all participants who were administered AVP in combination with placebo at any time point during the study.|||units on a scale||Standard Deviation|Mean
1323456|NCT02223429|Secondary|Difference in Cry Rating Scores Between OT and Placebo|"The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under OT and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents not at all and 7 represents extremely. Difference is defined as OT minus placebo scores."|Baseline, Visit 2 (Up to 10 days)|Of the 15 participants who were administered oxytocin in combination with placebo at any time point during the study, data were analyzed for 14 participants. One participant was excluded from the analysis due to missing data.|||units on a scale||Standard Deviation|Mean
1323457|NCT02223429|Secondary|Change in Plasma Levels of Oxytocin (OT)|Peripheral levels of OT will be assessed via assay of plasma collected.|Baseline, Visit 2 (Up to 10 days)|Zero participants were analyzed as samples were not assayed.||||||
1323458|NCT02223429|Secondary|Change in Plasma Levels of Vasopressin (AVP)|Peripheral levels of AVP will be assessed via assay of plasma collected.|Baseline, Visit 2 (Up to 10 days)|Zero participants were analyzed as AVP samples were not assayed.||||||
1323459|NCT02223429|Primary|Mean Percent Signal Change in the Anterior Cingulate Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|Analysis was conducted in the OT+placebo groups only.|||Percent signal change||Standard Deviation|Mean
1323460|NCT02223429|Primary|Mean Percent Signal Change in the Visual Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
1323461|NCT02223429|Primary|Mean Percent Signal Change in Caudate Nucleus|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
1323462|NCT02223429|Primary|Mean Percent Signal Change in Right Medial Orbitofrontal Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
1323463|NCT02223429|Primary|Mean Percent Signal Change in Right Ventral Striatum|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
1323600|NCT02220920|Secondary|Change in Fasting Plasma Glucose||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of fasting plasma glucose at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."|||mg/dL||Standard Error|Least Squares Mean
1323464|NCT02223429|Primary|Mean Percent Signal Change in Ventral Tegmental Area (VTA)|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
1323465|NCT02223364|Secondary|Balance Testing on Operative Leg Using Unipedal Stance Time|In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.|baseline, approximately 12 weeks|Intent-to-treat analysis|||seconds||Inter-Quartile Range|Median
1323466|NCT02223364|Secondary|Hospital Length of Stay|The hospital length of stay was measured from the date of admittance until the date of discharge.|Approximately 3 days|Intent-to-treat analysis|||days||Inter-Quartile Range|Median
1323467|NCT02223364|Secondary|POD 2 Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 2, approximately 12 am to 12 am next day|Intent-to-treat analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).|||mg OME||Inter-Quartile Range|Median
1323468|NCT02223364|Secondary|POD 1 Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 1, approximately 12 am to 12 am next day|Intent-to-treat analysis|||mg OME||Inter-Quartile Range|Median
1323469|NCT02223364|Secondary|POD 0 Post-PACU Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 0, approximately 12 pm to 12 am|Intent-to-treat|||mg OME||Inter-Quartile Range|Median
1323470|NCT02223364|Secondary|PACU Opioid Use|Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|Approximately 2 hours after entry in PACU|Intent-to-treat analysis|||mg OME||Inter-Quartile Range|Median
1323471|NCT02223364|Secondary|Intraoperative Opioid Use|Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|During the procedure, approximately 2 hours after start of the procedure|Intent-to-treat analysis|||mg OME||Inter-Quartile Range|Median
1323472|NCT02223364|Secondary|Preoperative Daily Opioid Use|Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.|baseline|Intent-to-Treat Analysis|||mg oral morphine equivalents (OME)||Inter-Quartile Range|Median
1323473|NCT02223364|Secondary|Maximum Pain POD 2 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 2, approximately 12 am to 12 am next day|Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).|||units on a scale||Inter-Quartile Range|Median
1323474|NCT02223364|Secondary|Average Pain POD 2 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 2, approximately 12 am to 12 am next day|Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on Peripheral Nerve Block (PNB) arm, 1 on Ropivacaine (PAI-R) arm, and 3 on Liposomal Bupivacaine (PAI-L) arm).|||units on a scale||Inter-Quartile Range|Median
1323475|NCT02223364|Secondary|Maximum Pain POD 1 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 1, approximately 12 am to 12 am next day|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
1323476|NCT02223364|Secondary|Average Pain POD 1 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 1, approximately 12 am to 12 am next day|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
1323477|NCT02223364|Secondary|Maximum Pain Post-PACU|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-operative Day 0, approximately 12 pm to 12 am|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
1323478|NCT02223364|Secondary|Average Pain Post-Postanesthesia Care Unit (PACU)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-operative Day 0, approximately 12 pm to 12 am|Intent-to-Treat analysis|||units on a scale||Inter-Quartile Range|Median
1323479|NCT02223364|Primary|Maximum Pain Post-Operative Day (POD) 1 (Morning)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-Operative Day 1, approximately 6 am to 12:00 pm|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
1323480|NCT02223338|Secondary|Average Number of Antibiotics to Which Isolated Organisms Were Resistant|Average number of antibiotics to which isolated organisms were resistant, isolated organisms include only coagulase negative Staphylococcus species and Staphylococcus aureus. Antibiotics are those described in the methods section.|Through study completion, average of 4 weeks|All isolates of coagulase negative Staphylococcus and Staphylococcus aureus|||antibiotics||Standard Deviation|Mean
1323493|NCT02223260|Primary|Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS|||second||Standard Deviation|Mean
1323601|NCT02220920|Primary|Change in HbA1c From Baseline||baseline and Week 16|Full analysis set, last observation carried forward|||Percent||Standard Error|Least Squares Mean
1325493|NCT02181127|Secondary|Percentage of the Above Subset of BG Values Less Than 70 mg/dl||2 weeks|||||||
1323481|NCT02223338|Primary|Number of Participants With Resistance of Ocular Flora to Commonly Used Post-injection Prophylactic Antibiotics|"Resistance of all coagulase negative staph and staph aureus species to a panel of commonly used antibiotics will be determined and compared between groups. Resistance will be measured using minimum inhibitory concentrations which will be tested on the Siemens MicroScan instrument by doubling broth dilutions. Antibiotic susceptibility interpretations using the categories S for susceptible, I for Intermediate and R for Resistance based on the Clinical and Laboratory Standards Institute (CLSI) guidelines.~Ciprofloxacin will be tested using the Biomerieux E test strip. The test directly quantifies antimicrobial susceptibility in terms of discrete MIC values on a continuous gradient strip. The MIC values are also based on the CLSI guidelines giving interpretations of S, I or R.~For information on other antibiotics to be tested, please contact the investigator or provide more characters for input."|Cultured organisms will be subjected to resistance panels once they have grown and been identified. Cultures will be followed for 7 days total, and if no growth is recorded at that time they will be considered sterile.|All culture positive samples growing Staphylococcus aureus or coagulase negative Staphylococcus species.|||Participants|||Count of Participants
1323482|NCT02223260|Secondary|Global Assessment of Acceptability and Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability and acceptability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set|||percentage of participants|||Number
1323483|NCT02223260|Secondary|Incidence of All AEs During the Treatment Period|Percentage of patients with all adverse events (AEs) during the treatment period (including REP).|Within two days after the administration of trial medication, up to 3 days|Treated set|||percentage of participants|||Number
1323484|NCT02223260|Secondary|Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.|"Percentage of patients with Incidence of all bleeding events(major, clinically relevant non-major (CRNM) & minor) during the treatment period (including the residual effect period).Bleeding events were classified as follow:~Major bleeding: 1) Fatal bleeding 2) Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL (20 g/L) in 24-h-period 3) Bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system 4) Bleeding that required surgical intervention in an operating suite. CRNM bleeding: 1) Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition 2) Bleeding that required medical or surgical intervention to restore haemostasis, other than in an operating suite. Minor bleeding defined as any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding."|Within two days after the administration of trial medication, up to 3 days|Treated set|||Percentage of participants|||Number
1323485|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters dTT (AntiFactor IIa activity) values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||R-Square|||Number
1323486|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters ECT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||R-Square|||Number
1323487|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters APTT values. For our simple regression model, R-squared is equal to the square of Pearson’s coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||R-Square|||Number
1323488|NCT02223260|Primary|Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||ratio||Standard Deviation|Mean
1323489|NCT02223260|Primary|Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||Ratio||Standard Deviation|Mean
1323490|NCT02223260|Primary|Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||ratio||Standard Deviation|Mean
1323491|NCT02223260|Primary|Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS|||second||Standard Deviation|Mean
1323492|NCT02223260|Primary|Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS|||second||Standard Deviation|Mean
1323494|NCT02223260|Primary|Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate|Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate.|2 hours (h) and 12h after drug administration on day 1|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least 1 PK/PD observation and had no important Protocol violations (PVs) with respect to statistical analysis of Pharmacokinetic (PK) or Pharmacodynamic (PD ) endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1323495|NCT02223065|Primary|Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
1323496|NCT02223065|Primary|Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
1323497|NCT02223065|Primary|Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
1323498|NCT02223065|Primary|Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
1323499|NCT02223065|Primary|Dapagliflozin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1 to 3 (Period 1) and Day 8 to 10 (Period 2)|Evaluable PK Population|||ng/mL||90% Confidence Interval|Geometric Mean
1323500|NCT02223065|Primary|Saxagliptin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng/mL||90% Confidence Interval|Geometric Mean
1323501|NCT02222870|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 28 post-final vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1323502|NCT02222870|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 28 post-final vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1323503|NCT02222870|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1323504|NCT02222870|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1323505|NCT02222870|Primary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|"Solicited Injection-site: 6 to < 36 months - Tenderness, Erythema, and Swelling; 3 to < 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to < 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to < 9 years - Fever, Headache, Malaise, and Myalgia.~Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-any injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1323506|NCT02222818|Secondary|Percentage of Effective CRT Pacing During AF (Superiority Test)|The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.|||percentage of effective CRT pacing||Standard Deviation|Mean
1323507|NCT02222818|Primary|Percentage of Effective CRT Pacing During AF (Non-inferiority Test)|The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.|||percentage of effective CRT pacing||Standard Deviation|Mean
1323508|NCT02222558|Primary|Percentage of Responders|Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.|Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24|Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.|||percentage of subjects|||Number
1325494|NCT02181127|Secondary|Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime||2 weeks|||||||
1323509|NCT02222493|Secondary|Serum Concentration Versus Time Summary: Period 3||Pre dose on Day 379, 435 and 547|Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.|||nanograms/milliliters||Standard Deviation|Mean
1323510|NCT02222493|Secondary|Serum Concentration Versus Time Summary: Period 2||Pre dose on Day 211, 267, 379 and 547|Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.|||nanograms/milliliters||Standard Deviation|Mean
1323511|NCT02222493|Secondary|Serum Concentration Versus Time Summary: Period 1||Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29|Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.|||nanograms/milliliters||Standard Deviation|Median
1323512|NCT02222493|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3|ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.|Baseline (Week 54 pre-dose) up to Week 78|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323513|NCT02222493|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2|ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.|Baseline (Week 30 pre-dose) up to Week 54|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323514|NCT02222493|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1|ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.|Baseline (Day 1) up to Week 30|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323515|NCT02222493|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3||Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligrams/litres||Standard Deviation|Mean
1323516|NCT02222493|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2||Baseline (Week 30 pre-dose), Week 38, 46 and 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligrams/litres||Standard Deviation|Mean
1323517|NCT02222493|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1||Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligram/litres||Standard Deviation|Mean
1323518|NCT02222493|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3|PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician’s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.|Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1323519|NCT02222493|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2|PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician’s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.|Baseline (Week 30 pre-dose), Week 38, 46 and 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1323602|NCT02220907|Secondary|Change From Baseline in Body Weight|The change from Baseline in Body Weight collected at Week 52.|Baseline, 52 Weeks|Full analysis set, last observation carried forward|||percentage of Body Weight||Standard Deviation|Mean
1323520|NCT02222493|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain (PAAP), Patient’s Global Assessment of Arthritis (PGA) and Physician’s Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1|PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician’s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.|Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1323521|NCT02222493|Secondary|Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3|Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.|Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||joints||Standard Deviation|Mean
1323522|NCT02222493|Secondary|Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2|Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.|Baseline (Week 30 pre-dose), Week 38, 46 and Week 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||joints||Standard Deviation|Mean
1323523|NCT02222493|Secondary|Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1|Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.|Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||joints||Standard Deviation|Mean
1323524|NCT02222493|Secondary|Number of Participants With Laboratory Abnormalities: Period 3|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.|Baseline (Week 54 pre-dose) up to Week 78|"Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||participants|||Number
1323525|NCT02222493|Secondary|Number of Participants With Laboratory Abnormalities: Period 2|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.|Baseline (Week 30 pre-dose) up to Week 54|"Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||participants|||Number
1323526|NCT02222493|Secondary|Number of Participants With Laboratory Abnormalities: Period 1|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.|Baseline (Day 1) up to Week 30|"Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||participants|||Number
1323603|NCT02220907|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in Fasting Plasma Glucose collected at Week 52.|Baseline, 52 Weeks|Full analysis set, last observation carried forward|||mg/dL||Standard Deviation|Mean
1323527|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3|AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.|Baseline (Week 54 pre-dose) up to Week 78|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323528|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2|AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.|Baseline (Week 30 pre-dose) up to Week 54|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323529|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1|AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.|Baseline (Day 1) up to Week 30|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323530|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.|Baseline (Week 54 pre-dose) up to Week 78|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323531|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.|Baseline (Week 30 pre-dose) up to Week 54|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323532|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Week 30|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
1323533|NCT02222493|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3|EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.|Week 62, 70 and Week 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
1323534|NCT02222493|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2|EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.|Week 38, 46 and Week 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323535|NCT02222493|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1|EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.|Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323550|NCT02222246|Secondary|Incidence of the Administration of Naloxone During Emergency Department Visit|Naloxone administered during the Emergency Department stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323536|NCT02222493|Secondary|Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3|ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.|Week 62, 70 and 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
1323537|NCT02222493|Secondary|Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2|ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.|Week 38, 46 and 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323538|NCT02222493|Secondary|Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1|ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient’s global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.|Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323539|NCT02222493|Secondary|Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3|DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.|Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1323540|NCT02222493|Secondary|Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2|DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.|Baseline (Week 30 pre-dose), Week 38, 46 and 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1323551|NCT02222246|Secondary|Incidence of the Need for Supplemental Oxygen During Emergency Department Visit|Need for supplemental oxygen during the Emergency Department stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323604|NCT02220907|Secondary|Change From Baseline in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.|Baseline, 52 Weeks|Full analysis set, last observation carried forward|||percentage of HbA1c||Standard Deviation|Mean
1323605|NCT02220907|Primary|Number of Participants With Adverse Events||52 Weeks||||participants|||Number
1325495|NCT02181127|Secondary|Number of Hypoglycemic Events as Determined From BG Measurements||2 weeks|||||||
1325496|NCT02181127|Secondary|MARD vs. All BG Measurements||2 weeks|||||||
1323541|NCT02222493|Secondary|Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1|DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.|Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30|The ITT Population was defined as all participants who were randomized to study treatment.|||units on a scale||Standard Deviation|Mean
1323542|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3|ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.|Week 62, 70 and 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
1323543|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2|ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.|Week 38, 46 and 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323544|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1|ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.|Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323545|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.|Week 62, 70 and 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
1323546|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.|Week 38, 46 and 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323547|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.|Week 2, 4, 6, 12, 22 and 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
1323548|NCT02222493|Primary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).|Week 14|The ITT Population was defined as all participants who were randomized to study treatment. The primary analyses for ACR20 at Week 14 were performed with the missing data imputed using a non-responder imputation method.|||participants|||Number
1323549|NCT02222246|Secondary|Incidence of the Need for Assistive Ventilation|Intubation or other assistive ventilation techniques - including bag, valve, or mask was performed during the ED stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1325497|NCT02181127|Secondary|Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime||2 weeks|||||||
1325498|NCT02181127|Secondary|Mean CGMG During Exercise||2 weeks|||||||
1323552|NCT02222246|Secondary|Incidence of Sedation During Emergency Department Visit|"Severe-to moderate sedation at any point from placement until discharge, based on sedation data collected every 30 minutes during that time period. Thus, a sedation variable was derived in which 0=no and 1=yes that moderate-severe sedation was reported by the patient at least once during the placement to discharge time interval. Sedations scoring was as follows: None was defined as awake and alert, Mild sedation was defined as responds to voice, Moderate sedation was defined as responds to touch, with or without voice and Severe sedation was defined as somnolent, difficult to arouse."|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323553|NCT02222246|Secondary|Incidence of Respiratory Distress (YES) During Emergency Department Visit|Respiratory distress at any point from placement until discharge, based on data collected every 30 minutes during that time period. Thus, a respiratory distress variable was derived in which 0=no and 1=yes that respiratory distress was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323554|NCT02222246|Secondary|Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit|Saturation of peripheral capillary oxygen < 95% (SPO2 < 95%) at any point from placement until discharge, based on SPO2 data collected every 30 minutes during that time period. Thus, a SPO2 variable was derived in which 0=no and 1=yes that SPO2 < 95% was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323555|NCT02222246|Secondary|Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit|Decrease in diastolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A diastolic variable was derived in which 0=no and 1=yes that a > 20% decrease of baseline diastolic blood pressure was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323556|NCT02222246|Secondary|Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit|Decrease in systolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A systolic variable was derived in which 0=no and 1=yes that a >= 20% decrease of baseline systolic blood pressure was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323557|NCT02222246|Secondary|Incidence of Vomiting During Emergency Department Visits|Vomiting at any point from placement until discharge, based on vomiting data collected every 30 minutes during that time period. Thus, a vomiting variable was derived in which 0=no and 1=yes that vomiting was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323558|NCT02222246|Secondary|Incidence of Nausea During Emergency Department Visits|Nausea at any point from placement until discharge, based on nausea data collected every 30 minutes during that time period. Thus, a nausea variable was derived in which 0=no and 1=yes that nausea was reported by the patient at least once during the placement to discharge time interval.|From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.|||Emergency Department Visits|Emergency Department Visits||Count of Units
1323559|NCT02222246|Secondary|Change in Pain Visual Analogue Scale (VAS) Scores Over Time|"Pain severity was assessed at arrival and every 30 minutes until discharge from the ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating “no pain” and 100 indicating “pain as bad as it could be” or “worst imaginable pain”. Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED.~A hierarchical random coefficients regression model for repeated measurements (type of mixed hierarchical mixed-effect model) was conducted on the pain scores collected at six time points (arrival, post-placement 30-min, 60-min, 90-min,120-min, discharge) to evaluate the trajectory of change in pain. Discharge occurred at 120 minutes or later during each visit, with the exception of one discharge at 54 minutes."|Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours|The entire observation period was not evaluated because the patient-specific protocol has a shorter time to discharge, and, there was data missing at random after 120 minutes. To avoid a biased result, the mixed model was conducted on the data collected every 30 minutes during initial 120 minutes (2 hours) and at discharge.|||Units on a 100 mm VAS|Emergency Department Visits|Standard Deviation|Mean
1323594|NCT02220998|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1323595|NCT02220998|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1323596|NCT02220998|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1323560|NCT02222246|Primary|Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)|Each ED study visit was the unit of analysis for the statistical methods addressing the primary outcome. The primary outcome was change in pain score from arrival to discharge. Pain severity was assessed at arrival and discharge from ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating “no pain” and 100 indicating “pain as bad as it could be” or “worst imaginable pain”.Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED. Thus, the difference in pain scores were calculated as the arrival minus discharge VAS scores, with higher positive pain difference or change scores indicating greater pain reduction.|Arrival in ED to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Units on a 100 mm VAS|Emergency Department Visits|Standard Deviation|Mean
1323561|NCT02222207|Secondary|Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.|||percentage of participants|||Number
1323562|NCT02222207|Secondary|Percentage of Participants With Individual Changes in BCVA of Greater Than Equal to (>=) 0 Letters of Vision From Study Week 4 to Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Week 4, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.|||percentage of participants|||Number
1323563|NCT02222207|Primary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A|Participants were assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS protocol. ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.|||Score on scale||Standard Deviation|Mean
1323564|NCT02222207|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A|Participants will be assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS. The participant’s ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 4|Full Analysis Set (FAS): included participants who received at least one dose of study medication.|||Score on scale||Standard Deviation|Mean
1323565|NCT02222181|Secondary|Diastolic Blood Pressure|Diastolic pressure <90 mmHg|weekly||||mmHg||Standard Deviation|Mean
1323566|NCT02222181|Secondary|Glycemia|Normal levels: 70-99mg/dL; diabetic: >121mg/dL.|two months||||mg/dL||Standard Deviation|Mean
1323567|NCT02222181|Secondary|Triglycerides|Normal level: 150mg/dL|three months||||mg/dL||Standard Deviation|Mean
1323568|NCT02222181|Secondary|Total Cholesterol|Total Cholesterol <200 mg/dL|Total Cholesterol||||mg/dL||Standard Deviation|Mean
1323569|NCT02222181|Secondary|Systolic Blood Pressure|Systolic pressure <140 mmHg|weekly||||mmHg||Standard Deviation|Mean
1323570|NCT02222181|Primary|Clinical Dementia Rating (CDR)|CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)|six months||||score||Standard Deviation|Mean
1323571|NCT02222181|Primary|Mini-mental State Examination (MMEE)|MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)|six months||||score||Standard Deviation|Mean
1323572|NCT02222129|Secondary|Time to First Opioid Use.|Time to first opioid use.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||||||
1323573|NCT02222129|Secondary|Length of Hospital Stay.|Length of hospital stay.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||||||
1323574|NCT02222129|Secondary|Visual Analog Pain Scores.|Visual analog pain scores.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||||||
1323575|NCT02222129|Primary|Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay|Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||mg (morphine equivalents)||Inter-Quartile Range|Median
1323576|NCT02221947|Other Pre-specified|Pharmacokinetic Parameters of Bryostatin.|Preliminary evaluation of pharmacokinetics and pharmacodynamics (Cmax, Tmax, AUClast).|Bryostatin plasma concentration pre-dose and at 15 min, 30 min, 1 hr, 1.5 hr, 2hr, 3hr and 6rs post dose.|Subjects who received a single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour (PK population)|||bryostatin plasma concentration (ng/mL)||Standard Deviation|Mean
1323597|NCT02220920|Secondary|"Percentage of Participants With Adverse Events and Hypoglycemia and Blood Glucose Decreased"||Week 16|"Safety analysis set. Safety Population reflects the as treated population, and one Canagliflozin (TA-7284) + Insulin participant actually received Placebo + Insulin."|||percentage of participants|||Number
1323598|NCT02220920|Secondary|Change in Blood Pressure||baseline and Week 16|Full analysis set, last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1323577|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|"HVLT-R (Hopkins Verbal Learning Test–Revised™) delayed recall (change from baseline). A 12-item word list: 3 learning trials. Score range = 0-12. The lower the number, the more impaired.~Repeatable Battery of Assessments for Neuropsychological Status (RBANS) figure recall; change from baseline. Score Range: 0-20. The lower the number, the more impaired. Digit Symbol Coding (observed), Score range: 0-125. The lower the number, the more impaired.~Clinical Dementia Rating- Sum of Boxes (CDR-SB, observed). Sum of 6 investigated domains (Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, Personal Care). Each subtest range is 0-3; Sum of all 6 subtest scores gives total CDR-SB score (range= 0-18).The higher the number, the more impaired.~Mini Mental State Exam, version 2 (MMSE-2), change from baseline. The MMSE-2 measures aspects of cognitionon a scale of 0-30. Lower scores indicate greater cognitive impairment."|Specified timepoints within 2 weeks post study drug infusion||||units on a scale||Standard Deviation|Mean
1323578|NCT02221947|Primary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|"Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall; change from baseline. HVLT consists of a 12-item word list drawn from 3 semantic categories, presented in 3 learning trials. Score range = 0-12. The lower the number, the more impaired.~Repeatable Battery of Assessments for Neuropsychological Status (RBANS) figure recall; change from baseline. Total Score Range: 0-20. Each portion of the drawing is scored 1 point for correctness and completeness and 1 point for being placed properly in relation to the rest of the drawing. Drawing and placement scores are summed for the item total. To obtain subtest total score, the drawing and placement scores are summed for each item. The lower the number, the more impaired."|48 hours post start of study drug infusion||||units on a scale, change from baseline||Standard Deviation|Mean
1323579|NCT02221947|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Evaluate the safety and tolerability of bryostatin 1 (hereinafter referred to as bryostatin) in patients with Alzheimer's Disease (AD) following a single intravenous (IV) dose.|Within 2 weeks of study drug dosing||||event|||Number
1323580|NCT02221674|Other Pre-specified|Change From Baseline (Visit 1, After Surgery) in Pain Intensity|"The change from baseline in pain intensity using the Face, Legs, Activity, Cry, Consolability Scale (FLACC Scale) at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 15 hours after a single dose of tapentadol.~The FLACC Scale is a behavioral scale for scoring postoperative pain in young children. It includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The scale is scored in a range of 0–10 with 0 representing no pain.~The pain intensity scores were summarized descriptively per scheduled time point."|Baseline; up to 15 hours after study medication|"For the Arm/Group Participants aged 6 months to less than 2 years only 7 values were available at the timepoint 6 hours after administration."|||units on a scale||Standard Deviation|Mean
1323581|NCT02221674|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
1323582|NCT02221674|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
1323583|NCT02221674|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
1325499|NCT02181127|Secondary|Percentage of Subjects With Mean CGMG < 154mg/dl||2 weeks|||||||
1323584|NCT02221674|Primary|Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
1323585|NCT02221674|Primary|Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP administration|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
1323586|NCT02221674|Primary|Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP administration|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
1323587|NCT02221648|Secondary|Number of Subjects Showing Improvement on Quality of Life Scale for Pain|The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.|6 weeks||||participants|||Number
1323588|NCT02221648|Secondary|Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment"|6 weeks||||participants|||Number
1323589|NCT02221648|Primary|Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)|The primary outcome measure in this protocol is the proportion of subjects that have VAS <4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by “no pain” (score of 0) and “worst imaginable pain” (score of 10).|6 weeks||||participants|||Number
1323590|NCT02221557|Primary|Percentage Change in Radiographic Measurement of Alveolar Ridge Height|Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).|Change from baseline to 6 months||||percentage of change||Standard Deviation|Mean
1323591|NCT02220998|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1323592|NCT02220998|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1323593|NCT02220998|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12||||percentage of participants||95% Confidence Interval|Number
1342777|NCT01909804|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1323607|NCT02220764|Secondary|Number of Fixed Dental Prostheses (FDPs) With Chip/s|Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.|3 years||||FDPs with chip/s|||Number
1323608|NCT02220764|Primary|Number of Fixed Dental Prostheses (FDPs) With Failure|"Failure was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period."|3 years||||FDPs with failure|||Number
1323609|NCT02220205|Secondary|Percent Change in Comfort Placing IUDs From Pre- to Post-insertion|Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.|Baseline to three months||||Percent change in comfort|||Number
1323610|NCT02220205|Primary|Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice|"Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.~Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better."|Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice||||Percent of tasks performed correctly||Inter-Quartile Range|Median
1323611|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.|||seconds||Standard Deviation|Mean
1323612|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.|||seconds||Standard Deviation|Mean
1323613|NCT02219997|Primary|Change in Braking Reaction Time From No-glare to Glare|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, up to Day 30|This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).|||seconds||Standard Deviation|Mean
1323614|NCT02219932|Secondary|Change From Baseline in ABILHAND Score Over 24 Weeks|"The ABILHAND Questionnaire measures a participant’s perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 (poor manual ability) to 100 (good manual ability); a positive change indicates an improvement in manual ability.~Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline ABILHAND and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the Day 1 assessment."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment and available data.|||units on a scale||Standard Error|Least Squares Mean
1323615|NCT02219932|Secondary|Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks|"The BBS is a widely used assessment tool to identify balance impairment. Functional activities such as reaching, bending, transferring, and standing are evaluated on the test to evaluate balance. Participants are asked to complete 14 tasks that are rated from 0 (cannot perform) to 4 (normal performance) for a total of 56 points. BBS scores range from 0 (poor balance) to 56 (good balance); a positive change indicates improvement.~Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline BBS and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1323632|NCT02219685|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4, 12, and 24 weeks after stopping study treatment with LDV/SOF, respectively.|Posttreatment Weeks 4, 12, and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1332623|NCT02057549|Primary|Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication||1 hour after study medication given||||Participants|||Count of Participants
1323616|NCT02219932|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks|"The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 (no impact of MS) to 100 (extreme impact of MS); a negative change indicates an improvement in function.~Data are based on a mixed model for repeated measures (MMRM) model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline MSIS-29 physical score and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1323617|NCT02219932|Secondary|Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks|"TUG is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.~A responder is defined as a participant with a mean improvement of at least 15% in TUG speed over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. Estimated proportion obtained from binomial proportions. There are 2 TUG tests given, and the average across the 2 tests is used to calculate average speed. Healthy participants below the age of 79 are expected to complete this task in 7-10 seconds (American College of Rheumatology). Missing data are handled using multiple imputation and baseline is defined as the mean over Screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||proportion of participants|||Number
1323618|NCT02219932|Primary|Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks|"MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking.~A responder is defined as a participant with a mean improvement of at least 8 points over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. If a participant has a mean MSWS-12 score of < 0.5 over the double-blind period, and a baseline MSWS-12 score of < 8 points, the participant is counted as a responder. A participant who indicates they cannot walk at all on MSWS-12 during any double-blind visit, and who shows severe disability and an inability to walk on other efficacy assessments is counted as a non-responder. Estimated proportion obtained from binomial proportions."|Baseline to 24 weeks|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||proportion of participants|||Number
1323619|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring the extent of negative attitudes about the future (pessimism) as perceived by adolescents and adults. The BHS consists of 20 true-false statements. Each of the 20 statements is scored 1 or 0. Of the 20 true-false statements, 9 are keyed FALSE, and 11 are keyed TRUE to indicate endorsement of pessimism about the future. The item scores are summed to yield a total score that can range from 0 to 20 with higher scores indicating greater hopelessness.|Baseline; Posttreatment Weeks 4 and 24|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1323620|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-report instrument for measuring the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The item scores are summed to yield a derived total score that can range from 0 to 63 with lower values indicating less depression.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1323621|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment|Activity impairment was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall activity impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from performing regular activities).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1323622|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment|Impairment in overall work productivity was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall work impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from working).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1323623|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1323624|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)|The CLDQ-HCV is a disease-specific questionnaire measuring health-related quality of life. CLDQ-HCV scores are calculated using participant responses to 29 questions divided into 4 domains: Activity/Energy, Emotion, Worry, and Systemic. An overall CLDQ-HCV score is calculated by taking the mean of all domain scores. Overall CLDQ-HCV scores range between 1 and 7, with higher scores representing better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1323625|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.|Baseline; Posttreatment (PT) Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1323626|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1323627|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
1323628|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
1323629|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
1323630|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
1323631|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
1323633|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1323634|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1323635|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1323636|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1323637|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1323638|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal myoinositol was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set|||ratio||Standard Deviation|Mean
1323639|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal choline was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set|||ratio||Standard Deviation|Mean
1323640|NCT02219685|Primary|Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal N-acetylaspartate (NAA) + N-acetylaspartylglutamate (NAAG) was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.|||ratio||Standard Deviation|Mean
1323641|NCT02219516|Primary|Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)|CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||mL/min||95% Confidence Interval|Geometric Mean
1323642|NCT02219516|Primary|Total Body Clearance Corrected for Bioavailability (CL/F)|CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||L/hr||95% Confidence Interval|Geometric Mean
1323643|NCT02219516|Primary|Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)|CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||L/hr||95% Confidence Interval|Geometric Mean
1323644|NCT02219516|Primary|Apparent Terminal Half-life (t1/2)|t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||hr||95% Confidence Interval|Geometric Mean
1323645|NCT02219516|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)|AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||ng.hr/mL||95% Confidence Interval|Geometric Mean
1323646|NCT02219516|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||ng.hr/mL||95% Confidence Interval|Geometric Mean
1323647|NCT02219516|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||hr||Full Range|Median
1323648|NCT02219516|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||ng/mL||95% Confidence Interval|Geometric Mean
1323649|NCT02219516|Secondary|Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine||Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)||||Maximum Percentage (%) Change||Standard Error|Mean
1323650|NCT02219516|Secondary|Incidence of Treatment-Emergent Adverse Events||5 weeks||||Number of participants|||Number
1323651|NCT02219503|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
1323652|NCT02219503|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
1323653|NCT02219503|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|"Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.~The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis."|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
1323654|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score|MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.|||percentage of participants|||Number
1323655|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score|The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.|||percentage of participants|||Number
1323656|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest|The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.|||percentage of participants|||Number
1323657|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests|"Improvement was defined as:~increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin~decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin~decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein~increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count~decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio."|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12 for the respective parameter.|||percentage of participants|||Number
1323658|NCT02219477|Secondary|Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12|Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method.|Up to 12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug and who had an assessment.|||percentage of participants||95% Confidence Interval|Number
1323725|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|12 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323659|NCT02219477|Secondary|Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure|On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window.|Up to 24 weeks during treatment|Intent to treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1323660|NCT02219477|Secondary|Percentage of Participants With SVR12 in Group 3|SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.|||percentage of participants|||Number
1323661|NCT02219477|Primary|Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2|SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.|12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.|||percentage of participants||95% Confidence Interval|Number
1323662|NCT02219464|Secondary|Number of Participants Who Needed Airway Assistance Interventions|(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).|During surgical procedure||||Participants|||Count of Participants
1323663|NCT02219464|Primary|Number of Participants With Oxygen Saturations Below 92%||During surgical procedure||||Participants|||Count of Participants
1323664|NCT02219282|Secondary|Insertion Time of Laryngeal Mask|Duration of insertion (second) Laryngeal Mask;second|During placement of Laryngeal Mask||||seconds||Standard Deviation|Mean
1323665|NCT02219282|Secondary|Ease of Placement Laryngeal Mask|Ease (according to Likert scale 1-4 point from easy to diffucult).|During Laryngeal mask placement||||Participants|||Count of Participants
1323666|NCT02219282|Secondary|Haemodynamic Response to Insertion of Airway Device.|Mean blood pressure (MBP) (mmHg) were recorded in both groups.|Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion||||mmHg||Standard Deviation|Mean
1323667|NCT02219282|Secondary|Oropharyngeal Leak Pressure|Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.|Baseline||||cm H20||Standard Deviation|Mean
1323668|NCT02219282|Primary|Number of Participants With Successful Laryngeal Mask Placement|The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.|Baseline|For one patient in each group, dentulous and edentulous, insertion of the LMU was unsuccessful on the third attempt, and these patients were intubated; therefore, these two patients were excluded from the study and were not included in the statistical analysis|||Participants|||Count of Participants
1323669|NCT02219256|Primary|Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
1323670|NCT02219256|Primary|Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
1323671|NCT02219256|Secondary|Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)|Results for ADA analysis were reported.|Baseline up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. Due to change in planned analysis testing of NAb activity of ADA positive samples was not analysed.|||percentage of participants|||Number
1323672|NCT02219256|Secondary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079||Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose|The PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.6 mg/kg SC dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.|||ng*day/mL||Standard Deviation|Mean
1323673|NCT02219256|Secondary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079||Day 1 pre-dose and at multiple time points (up to Day 78) post-dose|The PK analysis set:all participants who received study drug and had at least 1 measurable serum concentration of TAK-079.A valid AUClast was derived for TAK-079 0.6 mg/kgSC dose group only, since serum concentrations of TAK-079 were either below the LLOQ at all PK sampling time-points or too limited to estimate AUClast reliably for remaining arms.|||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Mean
1323674|NCT02219256|Secondary|Cmax: Maximum Observed Serum Concentration for TAK-079||Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose|The pharmacokinetic(PK) analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.03, 0.06 mg/kg IV and 0.6 SC mg/kg dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1323675|NCT02219256|Primary|Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
1323676|NCT02219256|Primary|Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant’s usual activities) and severe (causes considerable interference with the participant’s usual activities).|First dose up to Day 94|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
1323677|NCT02219087|Secondary|Hospital Readmission Not Including Admissions Planned Procedures||Participants will be followed for 30 days after leaving the hospital.||||participants|||Number
1323678|NCT02219087|Secondary|Total Cost of Care (Dollars)||Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Dollars||Full Range|Median
1323679|NCT02219087|Secondary|Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay|"Nausea~Vomiting~Constipation~Ileus~Pruritus~Respiratory depression~Over-sedation"|Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||participants|||Number
1323680|NCT02219087|Secondary|Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)||Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Milligrams||Standard Deviation|Mean
1323681|NCT02219087|Secondary|Length of Stay (LOS, in Days)||Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Days||Standard Deviation|Mean
1323682|NCT02219087|Secondary|Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay|VAS was measured using a scale that ranged from 0 to 10. Higher scores indicate more pain, or a worse outcome. Patients had pain measured a variable number of times following surgery before discharge. Mean VAS score during the hospital stay for each patient was calculated|Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Units on a scale||Standard Deviation|Mean
1323683|NCT02219087|Primary|Number Physical Therapy Sessions Necessary for Discharge|Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.|Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Physical Therapy Sessions||Standard Deviation|Mean
1323684|NCT02219009|Secondary|Proportion of Time During the Study Period When Participants Wear Their Patches|Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants’ patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.|Baseline to Week 8|ITT population - all participants who entered the trial and used the MIND1 system.|||% of time participants wore patch||Standard Deviation|Mean
1323685|NCT02219009|Secondary|Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.|Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.|Baseline to Week 8|ITT population - all participants who entered the trial and used the MIND1 system.|||percentage of participants||95% Confidence Interval|Number
1323686|NCT02219009|Primary|Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)|Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.|Baseline to Week 8|The intent-to-treat (ITT) population - all participants who entered the trial and used the MIND1 system|||percentage of participants||95% Confidence Interval|Number
1323742|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|6 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1323687|NCT02218697|Secondary|Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.|"Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4.~The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F."|At 28 days post-vaccination with Pneumovax™ 23|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1323688|NCT02218697|Secondary|Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)|"Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.~POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group."|At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1323689|NCT02218697|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|"The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml.~PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.~POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group."|At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1323690|NCT02218697|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1323691|NCT02218697|Secondary|Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1323692|NCT02218697|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1323693|NCT02218697|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 0 and Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1323694|NCT02218697|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1323695|NCT02218697|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|Within the 28-day (Days 0-27) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1323696|NCT02218697|Secondary|Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)|"Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.~Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination."|During the entire study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1323697|NCT02218697|Secondary|Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.|Throughout the study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1323698|NCT02218697|Secondary|Duration of Solicited General AEs.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Days||Full Range|Median
1323699|NCT02218697|Secondary|Duration of Local Adverse Events|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Days||Full Range|Median
1323700|NCT02218697|Secondary|Number of Subjects Reporting Solicited General Adverse Events (AEs)|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (>)39.0°C.~*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain"|Within 7 days (Days 0 - 6) after each dose and across doses.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1323701|NCT02218697|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs)|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 100mm.|Within 7 days (Days 0 - 6) after each dose and across doses.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1323702|NCT02218697|Primary|Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).|Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).|At 28 days after Pneumovax™ 23 vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||ug per ml||95% Confidence Interval|Geometric Mean
1323703|NCT02218697|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 28 post Influsplit™ Tetra vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1323704|NCT02218541|Secondary|Number of Participants With Provisional Crown Fit at Delivery|To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'|8 weeks post surgery||||Participants|||Count of Participants
1323705|NCT02218541|Secondary|Number of Participants With a Soft Tissue Response of Bleeding|To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.|6 months post surgery||||Participants|||Count of Participants
1323706|NCT02218541|Primary|Number of Participants With Abutment Margin Exposure > 0|Margin exposure of the abutment between groups at 6 months post surgery.|up to 6 months post surgery||||Participants|||Count of Participants
1323707|NCT02218307|Secondary|Quality of Life in Chronic Rhinosinusitis Patients|Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named Visual Analog Scale for Nasal Obstruction/Congestion. VAS for nasal obstruction is scale from 0 to 100 where 100 mean worse.|3 months||||Units on a scale||Standard Deviation|Mean
1323708|NCT02218307|Primary|Quality of Life in Chronic Rhinosinusitis Patients|"Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named SNOT 20 ( 20 questions for Sino-Nasal Outcome Test)~Snot20:~Scale 1 to 5 for 20 symptoms numbered below where 5 is the worst symptom. Total SNOT is scale from 0-100 where 100 is the worst.~The following are the elements:~1. need to blow 2. sneezing 3. runny nose 4. cough 5. postnasal drip 6. Thick nasal discharge 7. Ear fullness 8. Dizziness 9. Ear pain 10. facial pain/pressure 11. difficulty falling asleep 12. wake up at night 13. lack of a good night's sleep 14. wake up tired 15. Fatigue 16. Reduced productivity 17. Reduced concentration 18. frustrated/ restless/irritable 19. sad 20. Embarrassed"|3 months||||Units on a scale||Standard Deviation|Mean
1323709|NCT02218268|Primary|Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.|Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.|From baseline to one hour then 2 hours||||Percent of Pulse Pressure||95% Confidence Interval|Mean
1323710|NCT02218216|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided|Baseline to 3 months|Study was terminated and no subject outcome data were collected||||||
1323711|NCT02218203|Primary|Percent Change in Peak Pain Intensity|Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.|30 minutes post-infusion (Cmax)|Central neuropathic pain following SCI; we present the primary efficacy endpoint (percent change in peak pain intensity) of this nested IV lidocaine dose-response clinical trial independent of the dextromethorphan doses, because the distribution of the dextromethorphan doses is balanced across the lidocaine treatment arms.|||percentage change from baseline||Standard Error|Mean
1323712|NCT02218164|Secondary|Occurence of Treatment Related Serious Adverse Events (SAEs)|Number of participants with treatment emergent SAEs, overall and per Event Description.|1 year|All participants|||Participants|||Count of Participants
1323713|NCT02218164|Secondary|Overall Survival (OS)|OS: The time from registration to death or date of last contact. Participants with overall survival at 1 year. Kaplan–Meier estimator will be utilized.|1 year|All participants who received study treatment.|||Participants|||Count of Participants
1323714|NCT02218164|Secondary|Progression Free Survival (PFS)|PFS: Alive without RECIST progression. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|1 year|All participants|||months||95% Confidence Interval|Median
1323715|NCT02218164|Primary|Objective Response Rate (ORR)|ORR: Stable Disease (SD); Partial Response (PR); Complete Response (CR). Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|9 weeks per participant|All participants|||Participants|||Count of Participants
1323716|NCT02217982|Other Pre-specified|Number of Participants With Pre-Existing GI Conditions|The tertiary objective is to gather further data regarding pre-existing conditions (GE reflex, gastric bypass, stomach ulcer, etc) and their possible relationship to GI symptoms when initiating DMF.|7 Weeks|||||||
1323717|NCT02217982|Secondary|Diarrhea Reduction|The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.|7 Weeks|Not enough patients qualified and the study was terminated early.||||||
1323718|NCT02217982|Primary|Reported GI Symptoms|The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.|7 Weeks|Trial was shut down early as not enough patients qualified with GI symptoms their first 2 weeks after initiating DMF therapy||||||
1323719|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VerifyNow|12 hours|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||hours||Inter-Quartile Range|Median
1323720|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With MEA|12 hours|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||hours||Inter-Quartile Range|Median
1323721|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VASP|12 hours||||hours||Inter-Quartile Range|Median
1323722|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VerifyNow|2 hours|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||Percentage of Patients With HPR|||Number
1323723|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With MEA|2 hours|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Percentage of Patients With HPR|||Number
1323724|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VASP|2 hours||||Percentage of Patients With HPR|||Number
1323726|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|6 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323727|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|4 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323728|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|3 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323729|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|2 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323730|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|1 hour post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323731|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|30 minutes post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323732|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|prior to the initial ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
1323733|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|12 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323734|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|6 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323735|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|4 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323736|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|3 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323737|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|2 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323738|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|1 hour post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323739|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|30 minutes post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323740|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|prior to the initial ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
1323741|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|12 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
1323749|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6)|Exposure to ticagrelor metabolite during the first 6 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose||||ng*h/mL||Inter-Quartile Range|Median
1323750|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h)|Exposure to ticagrelor during the first 6 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose||||ng*h/mL||Inter-Quartile Range|Median
1323751|NCT02217878|Secondary|Time to Maximum Concentration for AR-C124910XX|Time to maximum concentration (Tmax) for AR-C124910XX|12 hours||||hours||Inter-Quartile Range|Median
1323752|NCT02217878|Secondary|Time to Maximum Concentration for Ticagrelor|Time to maximum concentration (Tmax) for ticagrelor|12 hours||||hours||Inter-Quartile Range|Median
1323753|NCT02217878|Secondary|Maximum Concentration of AR-C124910XX|Maximum concentration (Cmax) of AR-C124910XX|12 hours||||ng/mL||Inter-Quartile Range|Median
1323754|NCT02217878|Secondary|Maximum Concentration of Ticagrelor|Maximum concentration (Cmax) of ticagrelor|12 hours||||ng/mL||Standard Deviation|Mean
1323755|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)|Exposure to ticagrelor metabolite during the first 12 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||ng*h/mL||Standard Deviation|Mean
1323756|NCT02217878|Primary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)|Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||ng*h/mL||Standard Deviation|Mean
1323757|NCT02217800|Primary|The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment.||23 hours following each treatment||||participants with trough hGH < 2.5 µg/mL|||Number
1323758|NCT02217527|Secondary|Cognitive Function on Continuous Performance Task (CPT) for Those With CO<10 During First Assessment Day (Mon) of Attempt to Quit Smoking During Both JNJ and Plac Quit Periods|This measure of cognitive performance (mean of median speed of correct responding on computer keyboard to letters and numbers) was assessed only on Monday (day 1) of the 0-5 days during each drug/placebo condition. Data only from those shown to have CO<10 ppm were analyzed, to confirm responding during abstinence while on drug/placebo condition. Cognitive testing consisted of standard Continuous Performance Task (CPT), on active JNJ and on placebo phases. This measure is assessed to determine potential mechanism of drug efficacy in relieving disrupted cognitive processing function caused by tobacco deprivation and withdrawal.|first day during quit week on JNJ, and during quit week on placebo.|Only those participants able to quit or sharply limit smoking exposure during both JNJ and the placebo phases of testing, defined as those with CO<10 during both tests of cognitive performance when tobacco abstinent.|||ms time of correct responding||Standard Deviation|Mean
1323759|NCT02217527|Secondary|Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo|"Severity of withdrawal symptoms will be assessed with standard self-report measure of Minnesota Nicotine Withdrawal Scale (MNWS) each quit day during one week only on active JNJ, and each quit day during one week on placebo. Ratings are made on 0-100 visual analog scale, with 0=not at all to 100=very much, and are averaged to create a total score also ranging from 0-100. Higher scores indicate more severe withdrawal."|only on days quit while on JNJ or on placebo|Withdrawal severity on quit days for smokers interested in quitting soon, while attempting to quit briefly during one week on active JNJ or one week on placebo.|||units on a scale||Standard Deviation|Mean
1323760|NCT02217527|Primary|Quit Status|"Complete abstinence from smoking for 24 hr is counted as a quit day and is assessed daily from Mon-Fri for just one week, on the JNJ active drug and one week on placebo. This same Mon-Fri procedure for one week (only) is done for both drug phases. Total outcome in each drug condition therefore is number of quit days out of the five assessment days (range 0-5)."|up to one week each drug phase (0-5)|Smokers trying to quit each day during 5-day period on active JNJ, and then during 5-day period on placebo, in crossover design.|||number of days quit||Standard Deviation|Mean
1323761|NCT02217280|Primary|Circumferential Contrast Spread|"Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.~This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord)."|1 hour||||Participants|||Count of Participants
1323762|NCT02217280|Primary|Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.|Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.|1 hour||||cm||Standard Deviation|Mean
1323763|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Five-year Period From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)||||participants|||Number
1323764|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Age Group From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)||||participants|||Number
1323765|NCT02216695|Primary|Incidence of AKI-D From 1998-9 to 2012-13|The population incidence of acute kidney injury requiring dialysis (AKI-D) was calculated using mid-year population of England in each year from 1998 to 2013 and expressed as people per million population. This was calculated by dividing number of cases by mid year population of England and multiplying by million.|15-years||||cases per million population|||Number
1323766|NCT02216695|Primary|Secular Trends in the Mortality After Acute Kidney Injury From 1998 to 2013|A retrospective cohort study of patients with acute kidney injury in England over a period of fifteen years, describing the trends in the mortality of acute kidney injury.|Participants will be followed for the duration of hospital stay (average of 15 days)||||participants|||Number
1323767|NCT02216591|Other Pre-specified|Change in Mean Percent Adherence Across All Antiretroviral Medications||Baseline and 10 weeks||||Percent of doses||Standard Deviation|Mean
1323768|NCT02216591|Secondary|Change in Delay Discounting|Measured by Monetary-Choice Questionnaire (MCQ), a standardized task that measures delay discounting. Participants are presented with choices between smaller, immediate rewards and larger, delayed rewards (e.g., “Would you prefer $54 today or $80 in 30 days?). Participants’ hyperbolic discount parameter (k value) is determined by fitting data to the following discount function equation: Vimmediate = Vdelayed / (1 + kD), in which V is the reward value in dollars and D is delay in days. K-values on this scale can range from 0.00016 to 4.00 and to normalize scores, these values were ranked from 1 to 13 for analyses. A higher rank indicates greater delay discounting.|Baseline and 10 weeks||||Mean K value rank for MCQ||Standard Deviation|Mean
1323769|NCT02216591|Primary|Change in Working Memory|Standardized neuropsychological tests of working memory used in this study were the Paced Auditory Serial Addition Task-50 and Neuropsychological Assessment Battery Digits Forward/Digits Backward Test. Using the most up-to-date published normative data, raw test scores were converted to T-scores that corrected for demographic factors such as age and education. T scores can range from 0 to 100, with 50 being average and higher scores indicating better function. The overall working memory score was computed by averaging T-scores of each of the individual tests. To examine intervention effects on working memory outcomes, we conducted a 2 (Arm: ACT vs. CON) × 2 (Time: Baseline vs. Post) mixed-model general linear model analyses. Time was the within-subjects factor defined by baseline versus 10 week follow-up, and study arm was the between-subjects factor. Age and years of education were included as covariates. The means reported here are the mean scores at 10 weeks.|Baseline and 10 weeks||||mean T score on working memory tests||Standard Error|Mean
1323770|NCT02216526|Secondary|Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Cetaphil Group one value is missing for that question.|||units on a scale||Standard Deviation|Mean
1323771|NCT02216526|Secondary|Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.~Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.|||units on a scale||Standard Deviation|Mean
1323772|NCT02216526|Secondary|Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.|||units on a scale||Standard Deviation|Mean
1323773|NCT02216526|Secondary|Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.|||units on a scale||Standard Deviation|Mean
1323781|NCT02216526|Secondary|Quality of Sleep. Question 3. Awake All Night (0) – Awake Very Little (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
1324313|NCT02205801|Secondary|Post Operative Nausea Score|"Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means very severe)."|At 2 weeks after operation||||units on a scale||Standard Deviation|Mean
1323774|NCT02216526|Secondary|Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Excipial Group one value is missing for that question.|||units on a scale||Standard Deviation|Mean
1323775|NCT02216526|Secondary|Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline). One value in the Cetaphil Group is missing for this question.|||units on a scale||Standard Deviation|Mean
1323776|NCT02216526|Secondary|Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline|"Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.~Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
1323777|NCT02216526|Secondary|Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Baseline|Only participants not being cognitively impaired were able to answer the quastionnaires (in total n = 32/133 at baseline). One value in the Excipial Group is missing for this question.|||units on a scale||Standard Deviation|Mean
1323778|NCT02216526|Secondary|Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
1323779|NCT02216526|Secondary|Quality of Sleep. Question 5. Bad Sleep (0) – Good Sleep (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
1323780|NCT02216526|Secondary|Quality of Sleep. Question 4. Not Back to Sleep (0) – Back to Sleep Immediately (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
1323851|NCT02216097|Secondary|Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were QTc absolute value >=450 milliseconds (msec) or QTc absolute change >=30 msec.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
1323782|NCT02216526|Secondary|Quality of Sleep. Question 2. Never Fall Asleep (0) – Immediately Fall Asleep (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
1323783|NCT02216526|Secondary|Quality of Sleep. Question 1. Light Sleep (0) – Deep Sleep (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
1323784|NCT02216526|Secondary|Quality of Sleep. Question 5. Bad Sleep (0) – Good Sleep (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline)|||units on a scale||Standard Deviation|Mean
1323785|NCT02216526|Secondary|Quality of Sleep. Question 4. Not Back to Sleep (0) – Back to Sleep Immediately (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents being not cognitively impaired were able to answer the questionnaires (in total 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
1323786|NCT02216526|Secondary|Quality of Sleep. Question 3. Awake All Night (0) – Awake Very Little (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
1323787|NCT02216526|Secondary|Quality of Sleep. Question 2. Never Fall Asleep (0) – Immediately Fall Asleep (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133).|||units on a scale||Standard Deviation|Mean
1323788|NCT02216526|Secondary|Quality of Life Sum Score at Day 56 +/-3|Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from ‘5’ (all the time) to ‘0’ (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. ‘In the last two weeks … I was happy’ or ‘…I was relaxed’. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.|Day 56 +/-3|Only residents being cognitively not impaired were able to answer the questionnaires (in total n = 28/117 at the end of the study).|||units on a scale||Standard Deviation|Mean
1323789|NCT02216526|Secondary|Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3|Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification|Day 56 +/-3|In total n = 16 participants were loss to follow up after eight weeks (end of the study).|||Participants|||Count of Participants
1323790|NCT02216526|Secondary|Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3|Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification|Day 28 +/-3|In total n = 13 participants were loss to follow up after 4 weeks.|||Participants|||Count of Participants
1323791|NCT02216526|Secondary|Number of Participants With Skin Tears at Day 56 +/-3|Clinical assessment aof the presence of skin tears according to the STAR Classification|Day 56 +/-3|In total n = 16 participants were loss to follow up after eight weeks (end of the study).|||Participants|||Count of Participants
1323792|NCT02216526|Secondary|Number of Participants With Skin Tears at Day 28 +/-3|Clinical assessment aof the presence of skin tears according to the STAR Classification|Day 28 +/-3|In total n = 13 participants were loss to follow up after 4 weeks.|||Participants|||Count of Participants
1323793|NCT02216526|Secondary|Number of Participants With Skin Tears at Baseline|Clinical assessment of the presence of skin tears according to the STAR Classification|Baseline||||Participants|||Count of Participants
1323794|NCT02216526|Secondary|Number of Participants With Pressure Ulcer at Day 56 +/-3|Clinical assessment of the presence of a pressure ulcer.|Day 56 +/-3|At the end of the study, in total n = 16 participants were loss to follow up.|||Participants|||Count of Participants
1323795|NCT02216526|Secondary|Number of Participants With Pressure Ulcer at Day 28 +/-3|Clinical assessment of the presence of pressure ulcer.|Day 28 +/-3|After 4 weeks of the study, in total n= 13 participants were loss to follow up.|||Participants|||Count of Participants
1323890|NCT02215161|Secondary|Time to PSA Progression|Time between the first evaluation at which the response criteria are met and the first documentation of PSA (Prostate-Specific Antigen) progression or death. Progression is defined as a rise in PSA of 50% above nadir value or 25% above baseline if there is no decline.|Time between the first evaluation at which the response criteria are met and the first documentation of PSA progression or death or up to 3 years||||weeks||Full Range|Median
1323796|NCT02216526|Secondary|Quality of Life Sum Score at Baseline|Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from ‘5’ (all the time) to ‘0’ (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. ‘In the last two weeks … I was happy’ or ‘…I was relaxed’. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.|Baseline|Only residents being cognitively not impaired were able to answer the questionnaires (At baseline n = 32/133)|||units on a scale||Standard Deviation|Mean
1323797|NCT02216526|Secondary|Quality of Sleep. Question 1. Light Sleep (0) – Deep Sleep (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
1323798|NCT02216526|Secondary|Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline|Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification|Baseline||||Participants|||Count of Participants
1323799|NCT02216526|Secondary|Number of Participants With a Pressure Ulcer at Baseline|Clinical assessment of the presence of a pressure ulcer.|Baseline||||Participants|||Count of Participants
1323800|NCT02216526|Secondary|Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from ‘5’ (no pruritus) to ‘25’ (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example ‘What year is it?’ or ‘Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as ‘cognitively impaired’."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
1323801|NCT02216526|Secondary|Skin Surface pH|Changes in Skin surface pH at the lower leg. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.|Baseline, Day 56 +/- 4|At Day 56 +/- 3 data of six participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 32/36 participants were analyzed.|||units on a scale||Standard Deviation|Mean
1323802|NCT02216526|Secondary|Transepidermal Water Loss (TEWL)|Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.|Baseline, Day 56 +/- 4|At Day 56 +/- 3 data of twelve participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 36/40 participants were analyzed. In Group II (Excipial) 38/41 participants were analyzed. In Group III (Standard Skin care) 31/36 participants were analyzed.|||g/m2/h||Standard Deviation|Mean
1323803|NCT02216526|Secondary|Stratum Corneum Hydration (SCH)|Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.Values > 40 a.u. are often considered ‘normal’, whereas values < 40 a.u. are regarded as typical for dry Skin.|Baseline, Day 56 +/- 4|At Day 56 +/- 3 data of four participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 34/36 participants were analyzed.|||arbitrary units||Standard Deviation|Mean
1323804|NCT02216526|Primary|Change From Baseline in Overall Dry Skin Score (ODS)|Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.|Baseline; Day 56+/-4|At Day 56 +/- 3 data of two participants to calculate the Change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group III (Standard Skin care) 35/36 participants were analyzed.|||units on a scale||Standard Deviation|Mean
1323805|NCT02216422|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
1323891|NCT02215161|Secondary|Abiraterone Resistance Status (Primary Versus Acquired)|Comparison of radiographic progression free survival between patients with primary abiraterone resistance and acquired abiraterone resistance using a Cox proportional hazards model.|At baseline|The study was terminated due to unacceptable toxicity. Data on resistance type was not collected.||||||
1323806|NCT02216422|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
1323807|NCT02216422|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
1323808|NCT02216357|Secondary|Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.||Study Day 2 and 3||||Participants|||Count of Participants
1323809|NCT02216357|Secondary|Incidence and Severity of Asthmatic Reactions During the Treatment Period||Study Day 1 through 3||||Participants|||Count of Participants
1323810|NCT02216357|Secondary|Amount of Rescue Medication Required During the Aspirin Challenge|The amount of rescue medication required during the aspirin challenge|Study Day 2 and 3||||number of rescue medications||Standard Deviation|Mean
1323811|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3||||Participants|||Count of Participants
1323812|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3||||Participants|||Count of Participants
1323813|NCT02216357|Secondary|Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3||||Participants|||Count of Participants
1323814|NCT02216357|Secondary|Incidence and Severity of Treatment-emergent Adverse Events||Up to Study Day 7|Number of subject reporting at least one adverse event|||Participants|||Count of Participants
1323815|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Up to Study Day 2||||Participants|||Count of Participants
1323816|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Up to Study Day 2||||Participants|||Count of Participants
1323817|NCT02216357|Primary|Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Study Day 2||||Participants|||Count of Participants
1323818|NCT02216123|Secondary|Volume of Distribution (Vc/F) of TQ|Apparent population central volume of distribution of TQ|Day 2, Day 3, Day 8, Day 15, Day 29, Day 60 and Day 180|Safety Population|||Liters||90% Confidence Interval|Median
1323819|NCT02216123|Secondary|Oral Clearance (CL/F) of TQ|Apparent population oral clearance of TQ|Day 2, Day 3, Day 8, Day 15, Day 29, Day 60 and Day 180|Safety Population|||Liters per hour||90% Confidence Interval|Median
1323820|NCT02216123|Secondary|Number of Participants With Action Taken to Treat a Hemolysis Event|Health outcomes were evaluated based on the actions taken by the participants to treat hemolysis events. The number of participants in Brazil who attended the trial clinic to treat a hemolysis event has been presented. The aim of this outcome measure was to determine the action taken by a participant due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major differences in action taken by the participants with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan.|Up to Day 180|Safety Population|||Participants|||Number
1323821|NCT02216123|Secondary|Number of Participants With Action Taken to Treat Relapse Episode of P. Vivax Malaria|Health outcomes were evaluated based on the actions taken by the participants to treat relapse episode of P vivax malaria. The number of participants with the type of action taken to treat relapse episode of P vivax malaria has been presented by country. Participants may be represented in more than one category, so the total number of participants may be less than the number quoted. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Safety Population|||Participants|||Number
1323822|NCT02216123|Secondary|Number of Participants or Care Givers Who Had Taken Time Off From Normal Occupation Due to a Hemolysis Event|Health outcomes were evaluated based on total time lost by participants or care givers due to a hemolysis event. The number of participants or care givers who took days off from work due to a hemolysis event has been presented based on the normal occupation. The aim of this outcome measure was to determine the time taken off by participants due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major differences in time taken off by participants with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan.|Up to Day 180|Safety Population|||Participants|||Number
1323823|NCT02216123|Secondary|Number of Participants or Care Givers Who Had Taken Time Off From Normal Occupation Due to Relapse Episode of Malaria|Health outcomes were evaluated based on total time lost by participants or care givers due to an episode of malaria. The number of participants or care givers who had taken off from their normal occupation due to relapse episode of P vivax malaria has been presented by country. Participants may be represented in more than one category, so the total number of participants may be less than the number quoted. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Safety Population|||Participants|||Number
1324444|NCT02203630|Secondary|Number of Patients With ST-segment Abnormalities on ECG|ST Elevation of 1 mm in 2 or more consecutive leads or Horizontal or downsloping ST depression of 1 mm in 2 or more consecutive leads|Up to 28 days||||Participants|||Count of Participants
1323824|NCT02216123|Secondary|Cost Incurred With Purchase of Medications Associated With Hemolysis Event|Health outcomes were evaluated based on the cost of medications purchased. The total medication cost associated with hemolysis event has been presented. Medications recorded as “Other” and medications without costs are excluded from the analysis. The aim of this outcome measure was to determine the cost to a participant due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major cost differences with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan.|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
1323825|NCT02216123|Secondary|Cost Incurred With Purchase of Medications Associated With Relapse Episode of P. Vivax Malaria|Health outcomes were evaluated based on the cost of medications purchased. The total medication cost for paracetamol associated with relapse episode of P vivax malaria has been presented. Medications recorded as “Other” and medications without costs are excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
1323826|NCT02216123|Secondary|Cost Associated With a Hemolysis Event|Health outcomes were evaluated based on cost incurred due to clinically relevant hemolysis. The total cost was evaluated based on the amount spent on treatment, transport, medication and test. The costs associated with hemolysis event has been presented. The aim of this outcome measure was to determine the cost to a participant due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major cost differences with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan.|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
1323827|NCT02216123|Secondary|Cost Associated With Relapse Episode of P Vivax Malaria|Health outcomes were evaluated based on the total costs spent on treatment, transport, medication and tests. The cost was summarized according to the place at which the participant went to for care (drug shop, trial clinic, other clinic, hospital emergency center, other). The costs associated with a relapse episode of P. vivax malaria has been presented. Participants may be represented in more than one category, so the total number of participants may be less than the number quoted. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Safety Population. Only those participants who experienced a relapse or who had a follow-up visit for a relapse were included in the analysis.|||US Dollars (USD)||Standard Deviation|Mean
1323828|NCT02216123|Secondary|Change From Baseline in Percent Methemoglobin|Methemoglbin is an oxidized and inactive form of hemoglobin. Methemoglobin assessment was made with the aid of a non-invasive signal extraction pulse CO-Oximeter handheld machine. The change from Baseline in percent methemoglobin by treatment, time and sex has been summarized. The latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo) was considered as Baseline value. Change from Baseline is the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 120|Safety Population|||Percent change||Standard Deviation|Mean
1323829|NCT02216123|Secondary|Number of Participants With Retinal Changes From Baseline|Ophthalmic assessments were carried out at pre-qualified sites prior to randomization and at Days 29 and 90 and at withdrawal follow-up. Assessments were carried out at Day 180 (and up to resolution) if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Change from Baseline was calculated as the value at post dose visit minus the Baseline value. The number of participants with definite retinal change and questionable (ques) retinal change from Baseline has been presented. The number of participants with maximum change post-Baseline (definite when absent or questionable at Baseline) has been presented for either eye. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Ophthalmic Safety Population|||Participants|||Number
1323830|NCT02216123|Secondary|Number of Participants With Change in Best Corrected Visual Acuity Test Scores|Ophthalmic assessments were carried out at pre-qualified sites prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Change from Baseline is the value at post dose visit minus the Baseline value. Best corrected visual acuity was assessed individually for each eye. Scores were recorded as a ratio. The values were used to derive a logMAR score for statistical analysis where logMAR=-1x log10 (ratio score). The number of participants with change in Best Corrected Visual Acuity Test Scores from Baseline has been presented where possible change is defined as a change from Baseline >=0.12 to <0.3 and definite change is defined as a change from Baseline >=0.3 logMAR score. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Ophthalmic Safety Population|||Participants|||Number
1323831|NCT02216123|Secondary|Number of Participants With Keratopathy|Ophthalmic assessments were carried out at pre-qualified sites prior to randomization and at Days 29 and 90 and at withdrawal follow-up visit. Assessments were carried out at Day 180 (and up to resolution) if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. The number of participants displaying keratopathy in each eye has been summarized for each visit. The number of participants with new keratopathy at any time post Baseline is also reported. Ophthalmic Safety Population comprised of all participants in the Safety Population who have results from any eye assessments. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Ophthalmic Safety Population|||Participants|||Number
1323832|NCT02216123|Secondary|Number of Participants With P. Falciparum|Microscopic blood slides (two thick film and one thin film slide) were prepared and examined for asexual parasite count. The number of participants with positive P. falciparum asexual parasite count post Baseline has been summarized for each treatment arm.|Up to Day 180|mITT Population|||Participants|||Number
1323928|NCT02214121|Secondary|Percentage of Days of Opioid Analgesic Use (Age >=4) - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
1323833|NCT02216123|Secondary|Change From Baseline in Temperature|Vital signs were performed twice a day on Days 1 through 3, at least 4 hours apart, and immediately prior to PK measurements. The mean and standard deviation of pulse rate has been presented. The values presented does not include Day 3 assessments for participant number 570. Baseline value is defined as the latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo). Change from Baseline is the value at post dose minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Safety Population|||Celsius||Standard Deviation|Mean
1323834|NCT02216123|Secondary|Change From Baseline in Pulse Rate|Vital signs were measured twice a day on Days 1 through 3, at least 4 hours apart, and immediately prior to PK measurements. The mean and standard deviation of pulse rate has been presented. The values presented does not include Day 3 assessments for participant number 570. Baseline value is defined as the latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo). Change from Baseline is the value at post dose minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Safety Population|||beats per minute||Standard Deviation|Mean
1323835|NCT02216123|Secondary|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP)|Vital signs were measured twice a day on Days 1 through 3, at least 4 hours apart, and immediately prior to pharmacokinetic (PK) measurements. MAP was calculated as the sum of SBP and two times DBP divided by 3. The mean and standard deviation of SBP, DBP and MAP has been presented. The values presented does not include Day 3 assessments for participant number 570. Baseline value is defined as the latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo). Change from Baseline is the value at post dose minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Safety Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1323836|NCT02216123|Secondary|Number of Participants With Electrocardiogram (ECG) Findings|12 lead ECG was performed with the participant in a semi-supine position having rested in this position for at least 10 minutes. ECG assessments were performed in triplicate at screening followed by single ECGs 12 hours after the first dose of study medication and at Day 29. The number of participants with abnormal-clinically significant ECG findings have been presented. The 12 Hour Post Randomized Treatment (11.5-12.5 Hours) timepoint included all readings taken between 11.5 and 12.5 hours post randomized treatment. The 12 Hour Post Randomized Treatment (8-72 Hours) timepoint is a sensitivity analysis of the 12 Hour post randomized treatment timepoint, including all readings taken between 8 and 72 hours post randomized treatment. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 29|Safety Population|||Participants|||Number
1323837|NCT02216123|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) is defined as any untoward medical occurrence in a participant under clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations such as important medical events and events of possible drug induced liver injury with hyperbilirubinemia. TEAEs are defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ). Number of participants with TEAEs and serious TEAEs have been presented.|Up to Day 180|Safety Population|||Participants|||Number
1323838|NCT02216123|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Mid-stream urine was collected and analyzed for bilirubin, glucose, ketones, leukocyte esterase (LE), nitrites, occult blood, proteins and urobilinogen by dipstick method. The number of participants with abnormal urinalysis results (Trace, +, ++, +++, ++++) has been presented. Only those participants with data available at the specified data points were analyzed.|Up to Day 120|Safety Population|||Participants|||Number
1323839|NCT02216123|Secondary|Number of Participants With Hematology Laboratory Data Outside the Reference Range|Blood samples were collected for the evaluation of hematology parameters including eosinophils, leukocytes, lymphocytes, neutrophils, platelets, reticulocytes and methemoglobin. The number of participants with hematology laboratory data outside the extended normal range (F3) has been presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Participants having both High and Low values for Normal Ranges at any post-baseline visits for safety parameters were counted in both the High and Low categories.|Up to Day 120|Safety Population|||Participants|||Number
1323840|NCT02216123|Secondary|Number of Participants With Clinical Chemistry Laboratory Data Outside the Reference Range|Plasma or serum samples were anlalyzed to evaluate clinical chemistry parameters such as alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, creatine kinase, creatinine, glomerular filtration rate (GFR), indirect bilirubin and urea. The number of participants with clinical chemistry laboratory values outside the extended normal range (F3) has been presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Safety Population consisted of all randomized participants who received at least one dose of blinded study medication.|Up to Day 120|Safety Population|||Participants|||Number
1323852|NCT02216097|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
1324445|NCT02203630|Secondary|Total Time in Arrhythmia||Up to 28 days|only participants with arrhythmias included|||minutes|||Number
1323841|NCT02216123|Secondary|Number of Participants With Genetically Homologous and Genetically Heterologous P. Vivax Infections|Two drops of peripheral blood were collected onto pre-printed filter paper for subsequent deoxyribonucleic acid (DNA) extraction and polymerase chain reaction (PCR) analysis of Plasmodium species on all participants at screening (Day 1; pre-dose) and; if necessary, at the time of the first recrudescence/relapse or re-infection. PCR of the P. vivax genes, was used to distinguish between genetically homologous and genetically heterologous infection. The number of participants with genetically homologous and genetically heterologous P. vivax infections has been summarized for each treatment group. Only those participants with an infection occuring on or after Study Day 33 were analyzed.|Up to Day 180|mITT Population. Only those participants who had a recurrence of infection were included in the analysis.|||Participants|||Number
1323842|NCT02216123|Secondary|Number of Participants With Recrudescence|Recrudescence is defined as any P. vivax parasitemia occurring on or before Day 32 (that is, blood stage treatment failure). A participant was considered to have had a recrudescence if both of the following were true: a) Participant had a positive P. vivax asexual parasite count at Baseline and demonstrated clearance (that is, did not have two negative asexual P. vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval). b) Participant had a positive genetically homologous asexual P. vivax parasite count, after their zero count in Days 1 to 5, but on or before Study Day 32. The number of participants with recrudescence before Study Day 33 has been presented.|Up to Day 32|mITT Population|||Participants|||Number
1323843|NCT02216123|Secondary|Time to Gametocyte Clearance|Gametocyte clearance time is defined as time from first dose until the first slide that was gametocyte negative and remained so at the next slide reading. The time taken to achieve gametocyte clearance was analyzed by Kaplan-Meier method.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
1323844|NCT02216123|Secondary|Time to Fever Clearance|Fever clearance time is defined as the time from first dose of treatment to the time when body temperature falls to normal within Study Days 1-4 and remains normal for at least 48 hours up to the Day 8 visit. Fever clearance was considered to have been achieved once an initial temperature of more than 37.4 degree Celsius is reduced to a value less than or equal to 37.4 degree Celsius, in the absence of value more than 37.4 degree Celsius in the following 48 hours up to the Day 8 visit. The time taken to achieve fever clearance was analyzed by Kaplan-Meier method.|Up to Day 9|mITT Population|||Hours||95% Confidence Interval|Median
1323845|NCT02216123|Secondary|Time to Parasite Clearance|Parasite clearance time is defined as time needed to clear asexual parasite from the blood that is, parasite numbers falling below the limit of detection in the thick blood smear and remaining undetectable after 6 to 12 hours later. The time to achieve parasite clearance was analyzed by Kaplan-Meier methodology. The median parasite clearance time along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
1323846|NCT02216123|Secondary|Time to Relapse of P. Vivax Malaria|Relapse is defined by a positive blood smear with or without vivax symptoms. Relapse is described as any recurrence of malaria that occurred after Day 32 of the study. The time to relapse was analyzed by the Kaplan-Meier method. The median number of days to relapse along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Days||95% Confidence Interval|Median
1323847|NCT02216123|Secondary|Rate of Relapse-free Efficacy at Four Months Post Dose|A participant was considered to have demonstrated recurrence-free efficacy at 4 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P. vivax parasitemia. c) Participant had no positive asexual P. vivax parasite count at any assessment prior to or on Study Day 130 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment after Study Day 109 (up to and including Study Day 130). e) Participant is parasite-free at 4 months. The rate of relapse-free efficacy was estimated by Kaplan-Meier methodology. The percentage of participants who were relapse-free at 4 months post dose has been presented along with 95% confidence interval.|4 months post dose|mITT Population|||Percentage of participants||95% Confidence Interval|Number
1323848|NCT02216123|Secondary|Rate of Relapse-free Efficacy at Six Months Post Dose|A participant was considered to have demonstrated relapse-free efficacy at 6 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P. vivax parasitemia defined as two negative asexual P. vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval. c) Participant had no positive asexual P. vivax parasite count at any assessment prior to or on Study Day 201 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment. e) Participant is parasite-free at 6 months. The rate of relapse-free efficacy was estimated by Kaplan-Meier methodology. The percentage of participants who were relapse-free at 6 months post dose has been presented along with 95% confidence interval.|6 months post dose|Microbiologic-Intent-To-Treat (mITT) Population comprised of all randomized participants who received at least one dose of blinded study medication and had microscopically-confimed P. vivax parasitemia at Baseline.|||Percentage of participants||95% Confidence Interval|Number
1323849|NCT02216123|Primary|Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis.|Clinically relevant hemolysis is defined as a decrease in hemoglobin of >=30% or >3 g/dL from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL at any visit after the first dose of study medication. Despite additional efforts, no females with moderate G6PD-deficiency were enrolled that experienced clinically-significant hemolysis during the study; hence, the end point could not be estimated.|Up to Day 180|Safety Population||||||
1323850|NCT02216123|Primary|Percentage of Participants With Clinically Relevant Hemolysis.|Clinically relevant hemolysis is defined as a decrease in hemoglobin of >=30% or >3 grams per deciliter (g/dL) from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL at any visit after the first dose of study medication. The percentage of participants with clinically relevant hemolysis has been summarized. Safety Population comprised of all randomized participants who received at least one dose of blinded study medication.|Up to Day 180|Safety Population|||Percentage of participants||95% Confidence Interval|Number
1324446|NCT02203630|Secondary|Number of Participants With Arrhythmia Events||Up to 28 days||||Participants|||Count of Participants
1324447|NCT02203630|Primary|Maximum Heart Rate||Up to 28 days||||beats/minute||Full Range|Mean
1323853|NCT02216097|Secondary|Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); chemistry (glucose); urinalysis (dipstick) (urine pH, urine glucose, urine protein, urine blood, urine ketones, urine bilirubin, urine nitrite, urine leukocyte esterase); urinalysis microscopy (urine red blood cell, urine white blood cell, urine bacteria). Only parameters with abnormal values were reported.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
1323854|NCT02216097|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration that were absent before treatment or that worsened relative to pretreatment state. AEs included non-serious AEs and SAEs.|Baseline up to 28 days after last study drug administration (Day 35)|The safety analysis population included all participants who received study medication.|||participants|||Number
1323855|NCT02216097|Secondary|Number of Participants With Abnormal Physical Examination Findings|The full physical examination included head, ears, eyes, nose, mouth, skin, heart, and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline to up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
1323856|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left Amygdala|Difference measured in BOLD fMRI percent signal change in the left amygdala in fearful versus neutral faces during face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.||||||
1323857|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right Amygdala|Difference measured in BOLD fMRI percent signal change in the right amygdala in fear versus neutral faces during the emotional face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.||||||
1323858|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)|Difference measured in BOLD fMRI percent activation in the bilateral vmPFC during the fear extinction recall phase of the fear extinction paradigm.|Baseline, Day 2|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.||||||
1323859|NCT02216097|Primary|Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral Amygdala|Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance that resulted in data integrity and quality issues.||||||
1323860|NCT02215954|Secondary|Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire|"The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.~Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer~Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer"|Day 0 - Day 1|Intention-To-Treat Analysis set|||percentage of participants||95% Confidence Interval|Number
1323861|NCT02215954|Secondary|Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire|"The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.~Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)~Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)~Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)~Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)~Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)"|Day 0 - Day 1|Intention-To-Treat Analysis set|||units on a scale||95% Confidence Interval|Mean
1323862|NCT02215954|Secondary|The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale|The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set|||units on a scale||95% Confidence Interval|Mean
1323887|NCT02215161|Secondary|PSA Decline of ≥50% at 12 Weeks Post Therapy Initiation|The number of patients experiencing a PSA decline from baseline of at least 50% in PSA at 12 weeks following the initiation of study therapy.|At 12 weeks post therapy initiation||||Participants|||Count of Participants
1324448|NCT02203578|Secondary|T Cell Kinetics - Reconstitution||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1323863|NCT02215954|Secondary|The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale|The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set|||percentage of participants|||Number
1323864|NCT02215954|Primary|The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale|The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set|||percentage of participants|||Number
1323865|NCT02215252|Secondary|Plasma Concentration of PF-05089771|All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.|Baseline, Week 2 and Week 4|The PK concentration analysis set included all randomized participants who received at least one dose of study medication and who had at least 1 measurable concentration.|||ng/ml||Standard Deviation|Mean
1323866|NCT02215252|Secondary|Fasted Low Density Lipoprotein (LDL) Cholesterol|Percentage Change from Baseline in LDL cholesterol Friedewald by PEG|Baseline, Week 2 and Week 4|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Perecent change||Standard Deviation|Mean
1323867|NCT02215252|Secondary|Fasted Total Cholesterol Values|Percentage Change from Baseline in Fasted Total Cholesterol values|Baseline, Week 2 and Week 4|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Percent change||Standard Deviation|Mean
1323868|NCT02215252|Secondary|Number of Participants With Laboratory Test Values of Potential Clinical Importance|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.|Screening, Day 1, Day 15 and Day 29|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Participants|||Number
1323869|NCT02215252|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.|Screening to Day 36, and Day 64|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Participants|||Number
1323870|NCT02215252|Secondary|Number of Days Participants Take Rescue Medication|Number of days participants take rescue medication per week.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||days||Standard Deviation|Mean
1323871|NCT02215252|Secondary|Total Amount of Rescue Medication Per Week|Total amount of rescue medication participants take per week|Baseline, Week 1, Week 2, Week 3, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||mg||Standard Deviation|Mean
1323872|NCT02215252|Secondary|Daily Sleep Interference Scale Score (DSIS).|Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||number on a scale||Standard Deviation|Mean
1323873|NCT02215252|Secondary|Patient’s Global Impression of Change Score (PGIC).|"Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, Improved, No Change and Worse."|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
1323874|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Total Score|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1323888|NCT02215161|Secondary|Comparison of Leukocyte Exportin 1 (XPO-1) and Macrophage Inhibitory Cytokine-1 (MIC-1) Gene Expression Levels Pre- and Post-Selinexor Treatment|Total RNA isolated from leukocytes of patients will be used for quantitative polymerase chain reaction analysis (qPCR) in order to compare expression levels of XPO-1 and MIC-1 as a function of selinexor dose and total time on treatment.|On days 1 and 15 of course 1 and on day 1 of courses 2 and 3|The study was terminated due to unacceptable toxicity. Data was not collected.||||||
1343037|NCT01904760|Other Pre-specified|Sleep Quality in PACU|Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day|||||||
1323875|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1323876|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1323877|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1323878|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1323879|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain|Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1323880|NCT02215252|Secondary|Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score|Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).|Baseline, Week 1, Week 2, Week 3, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1323881|NCT02215252|Secondary|Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score|Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1323882|NCT02215252|Primary|Daily Pain Numeric Rating Scale (NRS)|The endpoint average pain score, based on the mean of the last 7 days’ daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1323883|NCT02215161|Secondary|Incidence of Serious Adverse Events|Incidence of serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 3 years after treatment start||||events|||Number
1323884|NCT02215161|Secondary|Time to Confirmed Development of >= 2 New Bone Lesions That Cannot be Attributable to Bone Scan Flare|Defined as time interval between the date of treatment initiation and the date of documented new lesions. Evaluation criteria is defined by the PSAWG2 (Prostate-Specific Antigen Working Group 2) criteria for bone scan evaluation. The time will be 'backdated' to when the >= 2 new lesions were detected if a second scan is done to confirm progression.|At week 8, 16, 24, and every 12 weeks thereafter up to 3 years after treatment start|The study was terminated due to unacceptable toxicity. Data was not collected.||||||
1323885|NCT02215161|Secondary|Serum Selinexor Levels|Serum selinexor trough levels as a function of dose and time since last dose|At day 1 of course 1, each treatment day until end of treatment up to 3 years|The study was terminated due to unacceptable toxicity. Data was not collected.||||||
1323886|NCT02215161|Secondary|Reduction in Pain for Symptomatic Patients, Measured Using the Brief Pain Inventory (BPI), Short Form|"The effect of selinexor on persistent pain associated with bone metastasis, measured using the Brief Pain Inventory (BPI), Short Form. 0 denotes ‘‘no pain’’ and 10, ‘‘pain as bad as you can imagine."|At baseline and day 1 of every following cycle until end of treatment or 3 years after study start|The study was terminated due to unacceptable toxicity. Only baseline data was collected.|||units on a scale||Full Range|Median
1345192|NCT01869686|Secondary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||days||Full Range|Median
1323892|NCT02215161|Primary|Radiographic Progression Free Survival (rPFS)|Defined as the time from study start until one of the following events occurs: >= 2 new bone lesions on technetium bone scan; Response Evaluation Criteria in Solid Tumors (RECIST)-defined tumor progression; clinical deterioration requiring a change in prostate cancer therapy, or at clinician discretion; surgery or radiation to treat a prostate cancer related indication; or death from any cause.|From study start up to 3 years||||weeks||Full Range|Median
1323893|NCT02214615|Secondary|Carbamazepine Affects Mean Duration of Pain Episode||15 days||||minutes|||Number
1323894|NCT02214615|Primary|Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation||15 days||||minutes|||Number
1323895|NCT02214420|Primary|Sustained Viral Response|Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.|12 weeks||||Participants|||Count of Participants
1323896|NCT02214277|Secondary|Captured Debris Histopathology (Observational)||Post-procedure|Only Test Arm patients had debris samples collected. Only samples with evaluable filters were used in the analysis.|||Participants|||Count of Participants
1323897|NCT02214277|Primary|Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days|Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.|30 Days Post-Procedure|Safety Arm and Test Arm. ITT with imputation.|||Participants|||Count of Participants
1323898|NCT02214277|Primary|Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.|Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.|Day 2-7 Post-Procedure|ITT with Imputation. Test Arm compared to the Control Arm.|||mm3||Inter-Quartile Range|Median
1323899|NCT02214238|Secondary|PAP Compliance|Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 31 had usable data for analysis after using both devices. Compliance was compared between devices independent of which order the participants used each device.|||Minutes||Standard Deviation|Mean
1323900|NCT02214238|Secondary|PAP Treatment Comfort|Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 35 had usable data for analysis after using each device. PAP treatment comfort was compared between devices independent of which order the participants used each device.|||Units on a Scale||Full Range|Median
1323901|NCT02214238|Primary|PAP Treatment Efficacy|The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 37 had usable data for analysis after using each device. AHI was compared between devices independent of which order the participants used each device.|||Events per hour||Standard Deviation|Mean
1323902|NCT02214225|Secondary|The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.|The number of participants reporting Serious Adverse Events for 6 months following vaccination.|For 6 months following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
1323903|NCT02214225|Secondary|The Frequency and Severity of Unsolicited AEs.|The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
1323904|NCT02214225|Secondary|The Frequency of Cellulitis-like Reaction and Cellulitis.|The number of subjects experiencing at least one episode of each event.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
1323905|NCT02214225|Secondary|The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).|The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.|For 7 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
1324449|NCT02203578|Secondary|Rate of Documented Infection||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1323906|NCT02214225|Secondary|Seroconversion Rates|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants||95% Confidence Interval|Number
1323907|NCT02214225|Secondary|Seroprotection Rates Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants||95% Confidence Interval|Number
1323908|NCT02214225|Secondary|Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Fold Change Titer (GMFI)||95% Confidence Interval|Geometric Mean
1323909|NCT02214225|Secondary|Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||95% Confidence Interval|Geometric Mean
1323910|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants analyzed|||Number
1323911|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).|"Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.~(GMT dispersion values are based on unadjusted GMT values.)"|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||Full Range|Geometric Mean
1323912|NCT02214225|Secondary|The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).|Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants analyzed|||Number
1323913|NCT02214225|Secondary|Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).|"Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.~Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint."|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||Full Range|Geometric Mean
1324450|NCT02203578|Secondary|Total Duration of Immunosuppressive Therapy||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1323914|NCT02214225|Primary|The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.|SCR (defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants|||Number
1323915|NCT02214225|Primary|Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).|Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||Full Range|Geometric Mean
1323916|NCT02214186|Primary|Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index|Renal dysfunction was stratified by the Acute Kidney Injury Network (AKIN) index in three stages, in terms of creatinine increase from baseline: stage 1 included an interval of 150–200%, stage 2 200%–300%, and stage 3 more than 300% or hemodialysis|Postoperative renal dysfunction||||participants|||Number
1323917|NCT02214186|Secondary|Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare activated partial thromboplastin time (APPT) and relation with control (R) in the restrictive and liberal groups.~APPT is a laboratory test that evaluates the efficiency of the intrinsic pathway of coagulation. The unit of measure is seconds and the results are presented as relation (R) with control."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (R) with control patients.|||ratio||Standard Deviation|Mean
1323918|NCT02214186|Other Pre-specified|Urine Output During Cesarean Section in Severe Pre-eclampsia|Urine output during cesarean section in severe pre-eclampsia under two different regimes of hydration (restrictive and liberal)|urine output during cesarean section (an average of 60 minutes)||||ml/h||Inter-Quartile Range|Median
1323919|NCT02214186|Secondary|International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare International Normalized Ratio (INR) of Prothrombin Time (PT) in the restrictive and liberal groups in preoperative, first and second day postoperative.~PT is expressed in seconds and the entered values represented the INR of PT among study participants and a control population."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (INR) with control patients.|||ratio||Inter-Quartile Range|Median
1323920|NCT02214186|Secondary|Platelets in Restrictive Fluid Management of Severe Preeclampsia|Compare platelets count in the restrictive and liberal groups during the first and second post-operative days.|preoperative, first and second day postoperative||||thrombocytes/mm3||Standard Deviation|Mean
1323921|NCT02214186|Secondary|Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration|Proteinuria in severe pre-eclampsia submitted to cesarean section under different regimes of hydration. Analyses in pre-operative and post-operative period.|Proteinuria in severe pre-eclampsia in in pre-operative and post-operative period||||g/dl||Inter-Quartile Range|Median
1323922|NCT02214186|Secondary|Cystatin C as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (Cystatin C) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative||||mg/L||Standard Deviation|Mean
1323923|NCT02214186|Secondary|Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (NGAL) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative||||mg/L||Inter-Quartile Range|Median
1323924|NCT02214186|Primary|Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy|Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.|preoperative, first and second day postoperative|Were included in the analysis the patients who violated the protocol and lost follow-up (intention to treat analysis)|||mg/dl||Inter-Quartile Range|Median
1323925|NCT02214121|Other Pre-specified|Haemorrhagic Events - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received. Erroneously treated patients will be accounted for in the actual treatment group.|||Number of events|||Number
1323926|NCT02214121|Other Pre-specified|Haemorrhagic Events - Part A||From randomisation to Part A (week 0) through Visit 4 (week 2)|All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||Number of events|||Number
1323927|NCT02214121|Secondary|Percentage of Days of Absence From School or Work (Age >=6) - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
1324124|NCT02209181|Secondary|Pain Relief (PAR) Scores at 5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1323929|NCT02214121|Secondary|Percentage of Days of Analgesic Use (Age >= 4) - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
1323930|NCT02214121|Secondary|Mean Intensity of Pain (Age >=4) - Part B|Pain measured using the Faces Pain Scale, range 0-10 (0, 2, 4, 6, 8, 10), where 0 is no pain|During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Mean score on scale||Standard Deviation|Mean
1323931|NCT02214121|Secondary|Percentage of Days With Pain (Age >=4) - Part B|Pain measured using the Faces Pain Scale, range 0-10 (0, 2, 4, 6, 8, 10), where 0 is no pain|During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
1323932|NCT02214121|Secondary|Percentage of Days Hospitalized for Vaso-occlusice Crisis or Other Complications of Sickle Cell Disease - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
1323933|NCT02214121|Secondary|Number of Vaso-occlusive Crises Requiring Hospitalization or Emergency Department Visits - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Number of events||Standard Deviation|Mean
1323934|NCT02214121|Secondary|Number of Vaso-occlusive Crises - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Number of events||Standard Deviation|Mean
1323935|NCT02214121|Secondary|Oral Clearance (CL/F) - Part B|The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||L/h||Standard Deviation|Geometric Mean
1323936|NCT02214121|Secondary|Oral Clearance (CL/F) - Part A|The PK parameter presented were derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||L/h||Standard Deviation|Geometric Mean
1323937|NCT02214121|Secondary|Assessment of AR-C124910XX Concentration - Part B|AR-C124910XX is the active metabolite of Ticagrelor|PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
1323938|NCT02214121|Secondary|Assessment of AR-C124910XX Concentration - Part A|AR-C124910XX is the active metabolite of Ticagrelor|In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
1323939|NCT02214121|Secondary|Assessment of Ticagrelor Concentration - Part B||PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
1323940|NCT02214121|Secondary|Assessment of Ticagrelor Concentration - Part A||In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
1323941|NCT02214121|Primary|Area Under the Plasma Concentration Time Curve (AUC) - Part B|The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||ng*h/mL||Standard Deviation|Geometric Mean
1324451|NCT02203578|Primary|Incidence of cGVHD||At 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1323942|NCT02214121|Primary|Area Under the Plasma Concentration Time Curve (AUC) - Part A|The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng*h/mL||Standard Deviation|Geometric Mean
1323943|NCT02214121|Primary|Maximum Plasma Concentration (Cmax) - Part B||PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
1323944|NCT02214121|Primary|Maximum Plasma Concentration (Cmax) - Part A||PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
1323945|NCT02214121|Primary|P2Y12 Reaction Units (PRU) - Part B||PRU measurements are taken after 4 weeks of double blind treatment at the end of Part B.|The PD analysis set is a subset of the safety analysis set, including all patients having at least one PRU measured. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||P2Y12 reaction units||Standard Deviation|Mean
1323946|NCT02214121|Primary|P2Y12 Reaction Units (PRU) - Part A||PRU measurements are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14). Up to 8 hours post-dose (6 hours following protocol amendment) Visit 2 and 3, and up to 2 hours Visit 4.|The PD analysis set is a subset of the safety analysis set, including all patients having at least one PRU measured. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||P2Y12 reaction units||Standard Deviation|Mean
1323947|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up|Test the efficacy of low dose haloperidol in reducing cognitive impairment at post-operative follow-up among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. Cognitive status is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS measures attention, language, visuospatial/constructional abilities, and memory. It is made up of 12 subtests. The subtests produce 5 index scores and a total scale score. All the subtest scores are summed to calculate a Total Index score. The Total Index score is presented. The Total Index score scale is from 0-100 with higher scores indicating less cognitive impairment.|Up to 3 months after hospital discharge on average.||||Units on a scale||Standard Deviation|Mean
1323948|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay|Test the efficacy of low dose haloperidol in reducing ICU and hospital length of stay among patients who are status post esophagectomy or pneumonectomy compared to placebo.|Date of hospital admission through date of hospital discharge, up to 3 weeks on average.||||Days||Standard Deviation|Mean
1323949|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing Days With Delirium|Test the efficacy of low dose haloperidol in reducing the number of days with delirium among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.|Up to 30 days||||Days with Delirium||Standard Deviation|Mean
1323950|NCT02213900|Primary|Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence|Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.|Up to 30 days||||Participants|||Count of Participants
1323951|NCT02213666|Primary|Intracardiac and Transesophageal Echo Results|The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.|Time of Clinical Procedure Only (Average 6 hours)||||participants|||Number
1323952|NCT02213510|Secondary|Patient Incision Pain|Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).|3 months||||units on a scale||Standard Deviation|Mean
1323953|NCT02213510|Secondary|Patient Incision Pain|At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).|2 weeks||||units on a scale||Standard Deviation|Mean
1323954|NCT02213510|Secondary|Patient Incision Pain|At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).|1 day (discharge)||||units on a scale||Standard Deviation|Mean
1323955|NCT02213510|Secondary|Patient Rating of Scar|"At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months||||units on a scale||Standard Deviation|Mean
1324452|NCT02203578|Primary|Incidence of cGVHD||At 9 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1323956|NCT02213510|Secondary|Patient Satisfaction With Scar|"Patient will complete questionnaires that includes assessments of the following:~Pain~Closure Method Comfort~Closure Method Satisfaction~Scar Satisfaction~Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months||||units on a scale||Standard Deviation|Mean
1323957|NCT02213510|Secondary|Patient Comfort|At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).|2 weeks||||units on a scale||Standard Deviation|Mean
1323958|NCT02213510|Secondary|Surgeon Satisfaction With Scar|"At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months||||units on a scale||Standard Deviation|Mean
1323959|NCT02213510|Secondary|Surgeon Evaluation Based on the Wound Evaluation Scale (WES)|"The surgeon will complete an assessment of the following:~Closure Method Satisfaction~Scar Satisfaction~Wound Healing as judged by Wound Evaluation Scale~Scale rated on 1 (least favorable) to 6 (most favorable)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 Months||||units on a scale||Standard Deviation|Mean
1323960|NCT02213510|Secondary|Surgeon Wound Evaluation Scale (WES)|At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).|2 weeks||||units on a scale||Standard Deviation|Mean
1323961|NCT02213510|Primary|Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)|Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).|3 Months|Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.|||mm||Standard Deviation|Mean
1323962|NCT02213510|Primary|Overall Closure Time|Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)|2 weeks||||seconds||Standard Deviation|Mean
1323963|NCT02213250|Secondary|Number of Subjects With Thrombogenicity||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
1323964|NCT02213250|Secondary|Number of Participants With Allergic Reactions||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
1323965|NCT02213250|Secondary|Number of Participants With Inhibitor Development||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
1323966|NCT02213250|Secondary|Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)||Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
1323967|NCT02213250|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)|Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.|Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
1323968|NCT02213250|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.|From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis set was defined as all participants who received at least 1 dose of BeneFIX.|||Particpants|||Number
1323969|NCT02213250|Primary|Incremental Recovery|Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.|Pre-dose, 0.25, 0.5 and 1 hour post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||(IU/dL)/(IU/Kg)||Geometric Coefficient of Variation|Geometric Mean
1323970|NCT02213250|Primary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
1323971|NCT02213250|Primary|Plasma Decay Half-Life (t½)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||hours||Standard Deviation|Mean
1323972|NCT02213250|Primary|Mean Residence Time (MRT)|AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||hours||Geometric Coefficient of Variation|Geometric Mean
1323973|NCT02213250|Primary|Terminal Phase Rate Constant (Kel)|Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1323974|NCT02213250|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||milliliter/kilogram (mL/kg)||Geometric Coefficient of Variation|Geometric Mean
1323975|NCT02213250|Primary|Time to Reach Cmax (Tmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||hours||Full Range|Median
1323976|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||IU*hr/ml||Geometric Coefficient of Variation|Geometric Mean
1323977|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||IU*hour/milliliter (IU*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1323978|NCT02213250|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||IU/milliliter (IU/mL)||Geometric Coefficient of Variation|Geometric Mean
1323979|NCT02213198|Primary|Engagement in Treatment|Whether patient kept appointment post TCC|baseline throught study completion|All patients for whom survey (call data) were available post TCC discharge|||Participants|||Count of Participants
1323980|NCT02213198|Primary|Subjective Quality of Life|The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life|baseline through study completion|All patients with baseline and at least one follow up on QOL|||units on a scale||Standard Deviation|Mean
1323981|NCT02213055|Primary|Number of Participants Free of Live Head Lice and Free of Viable Eggs|"A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.~At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice."|Day after first treatment and Day 14 of study|There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.|||Participants|||Number
1323982|NCT02212977|Secondary|Closure Materials Cost|Per unit cost for suture and octylcyanoacrylate|Baseline||||dollars|||Number
1323983|NCT02212977|Secondary|Closure Time|To compare closure time and associated costs between these two methods of skin closure.|Baseline||||minutes||Standard Deviation|Mean
1323984|NCT02212977|Secondary|Healing-incision Cosmesis Score by Visual Analogue Scale|To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.|3 months|Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.|||units on a scale||Standard Deviation|Mean
1323985|NCT02212977|Primary|Number of Participants With Complication of Infection|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months||||participants|||Number
1323986|NCT02212977|Primary|Number of Participants With Complication of Wound Dehiscence|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months||||participants|||Number
1323987|NCT02212834|Primary|Number of Breast Cancers Detected|Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI|12 months post surveillance exam||||cancers detected|exams||Number
1323988|NCT02212457|Secondary|Number of Subjects Reporting Any Serious AE (SAE)|The number of subjects reporting any SAE, possibly or probably related SAE(s), medically-attended AEs, AEs leading to premature withdrawal, AEs leading to death, AEs leading to hospitalization and AEs leading to dose reduction, interruption and delay in study vaccination during the entire study period is reported.|During the entire study period upto study completion, an average of 2 years|Analysis was done on all subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status, received a subject ID, received a study vaccination and have post-vaccination unsolicited AE records.|||Subjects|||Number
1324125|NCT02209181|Secondary|Pain Relief (PAR) Scores at 4 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1323989|NCT02212457|Secondary|Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity.|Number of subjects reporting any solicited local or systemic AEs and other indicators of reactogenicity from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.|At Day 1 (6 hours) to Day 7 after vaccination|Analysis was done on all subjects in the Solicited Safety Set-all screened subjects who provided informed consent & provided demographic &/ other baseline screening measurements,regardless of the subject’s randomization & vaccination status in the trial,received a subject ID,provided post-vaccination reactogenicity data & received study vaccination|||Subjects|||Number
1323990|NCT02212457|Secondary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination|The number of subjects reporting unsolicited AEs and possibly or probably related unsolicited AEs is reported.|Day 1 through Day 30 after any vaccination|Analysis was done on subjects in the Unsolicited Safety Set -all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status, received a subject ID, received a study vaccination & have either post-vaccination reactogenicity records.|||Subjects|||Number
1323991|NCT02212457|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination|Within 30 minutes after vaccination||2018-11-30|11/2018||||
1323992|NCT02212457|Secondary|Number of Subjects Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity.|Number of subjects reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after each vaccination.|Within 30 minutes after vaccination|Analysis was done on subjects in Solicited Safety Set - all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status in the trial, received a subject ID,provided post-vaccination reactogenicity data & received a study vaccination|||Subjects|||Number
1323993|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ LLQ for Serogroups C and Y, and for Three Serogroup B Test Strains.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥ LLQ for serogroups C and Y, and for three serogroup B test strains (M14459, M01-0240364 and M07-0241084) is reported.|At Month 0, Month 2, Month 3, Month 7 and Month 13.||2018-11-30|11/2018||||
1323994|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ at Each Time Point Against Serogroups A, C, W and Y and Serogroup B Test Strains|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ against serogroups A, C, W and Y and serogroup B test strains, was described.|At Month 0, Month 2, Month 3, Month 7 and Month 13||2018-11-30|11/2018||||
1323995|NCT02212457|Secondary|Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains.|The kinetic of immune response (at Months 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test strains, is reported.|At Month 2, Month 3, Month 7 and Month 13||2018-11-30|11/2018||||
1323996|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Serogroups A, C, W and Y and Serogroup B Test Strains|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against serogroups A, C, W and Y and serogroup B test strains, is reported.|At Month 0, Month 2, Month 3, Month 7 and Month 13.||2018-11-30|11/2018||||
1323997|NCT02212457|Secondary|hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the hSBA GMTs against serogroups A,C, W and Y and serogroup B test strains is reported.|At Month 0, Month 2, Month 3, Month 7 and Month 13||2018-11-30|11/2018||||
1323998|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2 month schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.|At Month 2, Month 3, Month 7 and Month 12||2018-11-30|11/2018||||
1323999|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroup B Test Strains.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 6 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against serogroup B test strains at 1 month after the last meningococcal vaccination.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3/Month 7)||2018-11-30|11/2018||||
1324000|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains.|The immunogenicity of the MenABCWY vaccine was compared to the immunogenicity of the Bexsero™ vaccine, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.|At Day 71||2018-11-30|11/2018||||
1324001|NCT02212457|Secondary|hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule is compared with those administered according to 0, 6 months schedule, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.|At Month 7||2018-11-30|11/2018||||
1324010|NCT02212197|Secondary|Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)|The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.|Days 0-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||ng/dL||Inter-Quartile Range|Median
1324002|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains.|"A sufficient immune response following Bexsero™ vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, was demonstrated. Criterion: the immune response will be considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titers ≥ LLQ is greater than 75% for each of the four serogroup B test strains.~The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab."|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)||2018-11-30|11/2018||||
1324003|NCT02212457|Secondary|hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains|The immunogenicity of MenABCWY vaccine, administered according to 0, 2 months schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.|At Month 0 (baseline), Month 2, Month 3, Month 7, and Month 13||2018-11-30|11/2018||||
1324004|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3/Month 7)|Analysis was done on the FAS 1 month after the last meningococcal vaccination. Analysis for this outcome measure was carried out only on the subjects in the ABCWY_0_2 group and ABCWY_0_2_6 group in the FAS 1 month after the last meningococcal vaccination, at each visit.|||Percentages of subjects||95% Confidence Interval|Number
1324005|NCT02212457|Secondary|hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.|"The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule is compared with those administered according to 0, 2 months schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.~The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated only in the ABCWY_ 0_2 and ABCWY_0_2_6 Groups.~The analysis was done on the Full analysis set (FAS) 1 month after the last meningococcal vaccination. 1 month post last meningococcal vaccination corresponds to Month 3 for ABCWY_0_2 Group and Month 7 for ABCWY_0_2_6 Group."|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3/Month 7)|Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.|||Titers||95% Confidence Interval|Geometric Mean
1324006|NCT02212457|Primary|Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains.|"The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero™) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported.~The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.~This outcome measure was evaluated only in the rMenB_0_2 and ABCWY_ 0_2 Groups."|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)|Analysis was done on the Per Protocol Set (PPS)–Month 3, ie,subjects in All Enrolled Set who:received a study vaccination, provided evaluable serum samples at pre- & post-vaccination, with results available for at least 1 serogroup B test strain & who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis|||Titers||95% Confidence Interval|Geometric Mean
1324007|NCT02212301|Primary|Time Controlled Visual Acuity|The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17” LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3” LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.|8 hours post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).|||LogMAR||Standard Deviation|Mean
1324008|NCT02212301|Primary|Tear Film Kinetics|The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.|8 hour post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.|||Seconds||Standard Deviation|Mean
1324009|NCT02212197|Secondary|Mean Prostate Specific Antigen (PSA) Concentration|The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.|Days 0-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||ng/mL||Inter-Quartile Range|Median
1324032|NCT02210208|Secondary|Part B Secondary Outcome.|Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.|14 days with 2 visits|ITT population|||Participants|||Count of Participants
1324453|NCT02203578|Primary|Incidence of cGVHD||At 6 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1324011|NCT02212197|Secondary|Time (Days) to Testosterone Recovery After Dose 3|The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.|Days 56-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||days||Standard Deviation|Mean
1324012|NCT02212197|Primary|Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.|Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324013|NCT02212197|Primary|Apparent Terminal Half-life (t½) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.|Days 0-28 and Days 56-84|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||hour||Standard Deviation|Mean
1324014|NCT02212197|Primary|Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).|84 days|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324015|NCT02212106|Secondary|The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The number of subjects experiencing at least one SAE.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Number of subjects|||Number
1324016|NCT02212106|Secondary|The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
1324017|NCT02212106|Secondary|The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
1324018|NCT02212106|Secondary|The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
1324019|NCT02212106|Secondary|The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.|Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
1324020|NCT02212106|Secondary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.|||Percentage of subjects|||Number
1324021|NCT02212106|Primary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.|||Percentage of subjects|||Number
1324022|NCT02212028|Secondary|Platelet Reactivity Index (PRI)|The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.|||PRI||95% Confidence Interval|Least Squares Mean
1324023|NCT02212028|Primary|P2Y12 Reaction Units (PRU)|The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.|||PRU||95% Confidence Interval|Least Squares Mean
1324024|NCT02211534|Secondary|Change in Pain Intensity - Average Pain Intensity|Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO).|At Days 75, 90, 150 and 240, as compared to Baseline|Data were not collected.||||||
1324025|NCT02211534|Secondary|Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm)|The maximal circumference of the calf and circumference of the thigh at 10 cm and 15 cm cranial to the superior pole of the patella of the index knee will be measured using a tape measure.|Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||cm||Standard Deviation|Mean
1324026|NCT02211534|Secondary|Change From Baseline in Range of Motion (ROM)|The degree of passive (movement of the knee with the aid of study personnel) and active (subject moving the knee) knee flexion and extension tolerated by the subject will be recorded. ROM will be assessed in the sitting position using a goniometer.|Days 0 (Baseline) and Day 75||||degrees of motion||Standard Deviation|Mean
1324027|NCT02211534|Secondary|Analgesic Consumption|Consumption of opioid analgesics in the preceding 24 hours will be self-reported by the subject in the ePRO diary on a daily basis during the 10-day run-in period, treatment period and through Day 75. The results below display the difference in opioid analgesic consumption from baseline to Day 56-60. Subject recorded the number of tablets consumed.|Day 56 to Day 60 (compared to baseline)|Number of Participants Analyzed differs from numbers above due to the number of subjects reporting opioid analgesic consumption in their ePRO diary.|||Number of tablets taken||Standard Deviation|Mean
1324028|NCT02211534|Secondary|Patient Global Impression of Change (PGIC)|"Responder Analysis at Day 75 (patents stating they are Improved to Much Improved) using the Patient Global Impression of Change (PGIC). PGIC is a 7-point validated categorical scale of overall change in status since initiation of treatment with the study device. PGIC allows subjects to integrate into one overall evaluation the different aspects of their response to treatment, including pain reduction, improvement in functioning and side effects. Subjects select one of the following response at the end of treatment: Very Much Worse, Much Worse, Minimally Worse, No Change, Minimally Improved, Improved, or Much Improved."|Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||Participants|||Count of Participants
1324029|NCT02211534|Secondary|Beck Depression Inventory (BDI)|"Responders: Defined as subjects with a 5-point decrease in Beck Depression Inventory (BDI) score.~BDI is a validated self-reported assessment of current symptoms of depressive disorders, with total scores ranging from 0 to 63. The BDI scale consists of 21 groups of statements with each score/response ranging from 0 to 3. Higher scores represent greater depression. The BDI was conducted at baseline prior to study device treatments and again at Day 61."|Responders at Day 75 (compared to baseline)|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||Participants|||Count of Participants
1324030|NCT02211534|Secondary|Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)|Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 categories: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Patients are asked to answer questions relating to these categories and respond with Never/None/Not at all, Rarely/Monthly/Mild, Sometimes/Moderate/Weekly, Often/Severe/Daily or Always/Extreme/Totally/Constantly. Each response gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The mean change in score from baseline to Day 75 is displayed below.|Mean change from Day 0 to Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||units on a scale||Standard Deviation|Mean
1324031|NCT02211534|Primary|Change in Pain Intensity|"Percent change from Baseline in Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). A score of 0 represents 'No Pain' while a score of 10 represents Worst Pain Imaginable."|Assessed at Day 60 as compared to Baseline|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 60 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 60 assessment. Subjects without a Day 60 assessment were left out of the analysis.|||Units on a scale||Standard Deviation|Mean
1324033|NCT02210208|Secondary|Part A Secondary Outcome.|"Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.~Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing."|14 days with 2 visits|ITT population|||Participants|||Count of Participants
1324034|NCT02210208|Primary|Part B|Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).|14 days with 2 visits|ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.|||Participants|||Count of Participants
1324035|NCT02210208|Primary|Part A: Number of Participants With Healing|Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).|14 days|ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.|||Participants|||Count of Participants
1324036|NCT02210195|Primary|Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.|Week 0 and Week 8||||drinks/week||Standard Deviation|Mean
1324037|NCT02210195|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).|Week 0 and Week 8||||ng/mg||Standard Deviation|Mean
1324038|NCT02210091|Post-Hoc|Pharmacokinetics (PK): Plasma Half-life Ratio of BAX 855 to ADVATE|This is a descriptive summary of the ratio of plasma half-life in the same subject for BAX 855 compared to ADVATE based on the final covariate model (first observation tabulation).|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||hours (hr)||Full Range|Mean
1324039|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - Chromogenic Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.~For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category Chromogenic assay - BAX 855~For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.~Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 Exposure Days [EDs], whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6.|||IU/dL : IU/kg||Standard Deviation|Mean
1324040|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - One Stage Clotting Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.~For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category One stage clotting assay - BAX 855~For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.~Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 EDs, whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6|||IU/dL : IU/kg||Standard Deviation|Mean
1324041|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A non-compartmental model approach was implemented to analyze IR data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||IU/dL : IU/kg||Standard Deviation|Mean
1324061|NCT02210091|Primary|Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)|Inhibitory antibodies to FVIII were measured using the Nijmegen modification of the Bethesda assay. Incidence of an FVIII inhibitory antibody was defined as an inhibitor level ≥0.6 Bethesda units [BU].|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the BAX 855 Safety Analysis Set who developed an inhibitor at any time plus participants who did not develop an inhibitor, had 50 or more exposure days (EDs) to BAX 855 and had FVIII Inhibitory test results after 50 EDs.|||participants|||Number
1324454|NCT02203578|Primary|Incidence of cGVHD||At 3 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1324042|NCT02210091|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||litre (L)||Standard Deviation|Mean
1324043|NCT02210091|Secondary|Pharmacokinetics (PK): Plasma Half-life (T1/2)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||hours (hr)||Standard Deviation|Mean
1324044|NCT02210091|Secondary|Pharmacokinetics (PK): Clearance (CL)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||L/hr||Standard Deviation|Mean
1324045|NCT02210091|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||hours (hr)||Standard Deviation|Mean
1324046|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion Per Dose, (AUC0-∞/Dose)||(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|The PK parameters were derived using a non-compartmental estimation approach using a flexible sampling design to provide point and interval estimates for summary PK parameter using a batch method. AUC/Dose is not a standard output parameter so this calculation was not done.||||||
1324047|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion (AUC0-∞)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set.|||IU•hr/L||Standard Deviation|Mean
1324062|NCT02210052|Primary|Number of Procedures in Which Temperature of Screws Increased|The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.|2 hours|There were 6 participants, but some participants had more than 1 procedure. There were a total of 10 procedures analyzed.|||procedures|Procedures||Number
1324048|NCT02210091|Secondary|Positive Post-baseline Binding Antibodies to Factor VIII (FVIII), Polyethylene Glycol-Factor VIII (PEG-FVIII), PEG and Chinese Hamster Ovary (CHO) Proteins|"Binding antibodies to FVIII and PEG-FVIII, as well as to PEG, were measured using enzyme-linked immunosorbent assay (ELISA). Both immunoglobulin G (IgG) and immunoglobulin M (IgM) binding antibodies for FVIII, BAX 855, and PEG were tested at each study visit. Testing for binding antibodies to CHO was performed on citrate-anti-coagulated plasma using an ELISA employing polyclonal anti-human IgG antibodies.~This outcome measure includes antibodies that were transient (antibody developed after exposure to BAX 855 but not present at study termination/completion) and pre-existent (antibody originally present before exposure to BAX 855)."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set: Data not available for 1 participant in the 6 to <12 years group as participant was prematurely withdrawn from study.|||participants|||Number
1324049|NCT02210091|Secondary|Number of Clinically Significant Changes in Clinical Laboratory Parameters (Hematology, Clinical Chemistry, Lipids)|"The HEMATOLOGY PANEL consisted of complete blood count: hemoglobin, hematocrit, erythrocytes (ie, red blood cell count), leukocytes (ie, white blood cell count) with differential (ie, basophils, eosinophils, lymphocytes, monocytes, and neutrophils), mean corpuscular volume, mean corpuscular hemoglobin concentration, and platelet count.~The CLINICAL CHEMISTRY PANEL consisted of sodium, potassium, chloride, bicarbonate, total protein, albumin, ALT, aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, and glucose.~The LIPID PANEL consisted of cholesterol, very low density lipoprotein, low density lipoprotein, high density lipoprotein, and triglycerides.~For each laboratory parameter value that changed from normal at baseline to abnormal at any subsequent study visit, the Investigator determined if the value was clinically significant, or not."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||clinically significant findings|||Number
1324050|NCT02210091|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs: body temperature (°C), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (mmHg). For each vital sign value that changed from normal at baseline to abnormal at any subsequent study visit, the Investigator determined if the value was clinically significant (i.e. and adverse event), or not.|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||participants|||Number
1324051|NCT02210091|Secondary|Non-serious Adverse Events Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||adverse events|||Number
1324052|NCT02210091|Secondary|Serious Adverse Events (SAEs) Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||serious adverse events|||Number
1324053|NCT02210091|Secondary|Hemostatic Efficacy Rating for Bleeding Episodes Treated With BAX 855 at Resolution of Bleed|"Rating Scale for Treatment of Bleeding Episodes (BEs) (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the Full Analysis Set who had treated bleeding episodes.|||bleeding episodes|bleeding episodes||Number
1324054|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.|||IU/kg|bleeding episodes|Standard Deviation|Mean
1324055|NCT02210091|Secondary|Consumption of BAX 855: Number of Infusions Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.|||infusions||Standard Deviation|Mean
1324056|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||IU/kg||Standard Deviation|Mean
1324057|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||IU/kg||Standard Deviation|Mean
1324058|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||infusions per year||Standard Deviation|Mean
1324059|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||infusions per month||Standard Deviation|Mean
1324060|NCT02210091|Secondary|Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during the prophylaxis period was assessed based upon each individual bleeding episode, spontaneous or traumatic, recorded in the participant´s diary and/or recorded in the physician/nurse/study site notes.~The annualized bleeding rate was analyzed using a generalized linear model framework assuming a negative binomial distribution with a logarithmic link function and presence or absence of target joints and age cohort as covariates and duration of the observation period in years as offset. Point estimates for the mean and 95% confidence intervals are presented."|During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Full Analysis Set: All participants who received at least 1 dose of BAX 855 in either PK or prophylaxis part of study|||bleeding episodes per year||95% Confidence Interval|Mean
1324089|NCT02209506|Secondary|Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ratio||Standard Deviation|Mean
1324063|NCT02210000|Secondary|Trough Plasma Concentration of Camicinal on Day 28 and Day 84|A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.|Day 28 and Day 84|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||NANOGRAM PER MILLILITER (NG/ML)||Standard Deviation|Mean
1324064|NCT02210000|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.|Up to end of follow up (100 days)|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
1324065|NCT02210000|Secondary|Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period|Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (<30 G/L), calcium low (<2 or >2.75 millimoles per Liter [mmol/L]), creatinine (>44 micromoles per Liter change from baseline), Glucose (<3 or >18 mmol/L), potassium (<3.0 or >5.5 mmol/L), sodium (<130 or >150 mmol/L), and carbon di oxide (CO2) (<18 or >35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
1324066|NCT02210000|Secondary|Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period|Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC <1.5 Giga per Liter [G/L]), hemoglobin (<25 or >25 G/L), hematocrit (<0.075 or >0.075 %), platelet count (<100 or >500 G/L), lymphocytes low (<0.8 G/L), and white blood cells (WBC <3 G/L or >20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration >53 nano-grams per milliliter (ng/mL).|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
1324067|NCT02210000|Secondary|Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days|The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of < 110 and > 220 milliseconds (msec), QRS interval of <75 and > 110 msec, absolute QTc interval of > 450 to ≤ 480 or > 480 to ≤ 500 or >500 msec, and increase from Baseline in QTc of > 30 to ≤ 60 msec or >60 msec was considered as of abnormal.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
1324068|NCT02210000|Secondary|Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day|Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
1324069|NCT02210000|Secondary|Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days|Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (>160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.|Up to 100 days|Safety Population comprised of participants who received at least one dose of the study drug and were followed-up for at least one post-Baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
1324090|NCT02209506|Secondary|Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ratio||Standard Deviation|Mean
1324091|NCT02209506|Secondary|Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15|M-I is the inactive metabolite of MLN3126.|Day 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng/mL||Standard Deviation|Mean
1324070|NCT02210000|Secondary|Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12|Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7, 8; fullness/early satiety subscale was mean of items 4, 6, 10, 11; bloating subscale was mean of items 5, 9. Total GCSI-DD score was mean of 3 subscales. For all, 0 indicated absence of symptom and higher score indicated greater severity of symptoms. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.|Baseline (Screening) and Week 12|ITT Population. Only those participants available at the time of assessment were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1324071|NCT02210000|Primary|Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI–DD) at Week 12|The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.|Week 12|Intent-to-treat (ITT) Population comprised of all randomized participants.|||Percentage of responders|||Number
1324072|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1324073|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1324074|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1324075|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1324076|NCT02209766|Primary|Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)|Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)|from first dosing (Day1) until follow-up (Day25)||||subjects|||Number
1324077|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
1324078|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1324079|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
1324080|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1324081|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
1324082|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1324083|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
1324084|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1324085|NCT02209506|Secondary|CLr: Renal Clearance of MLN3126 and Its Metabolite|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr). M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.||||||
1324086|NCT02209506|Secondary|Fe (0-4): Fraction of Dose of MLN3126 and Its Metabolite Excreted Unchanged in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.||||||
1324087|NCT02209506|Secondary|Ae (0-4): Amount of MLN3126 and Its Metabolite Excreted in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.||||||
1324088|NCT02209506|Secondary|Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ratio||Standard Deviation|Mean
1324092|NCT02209506|Secondary|Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1|M-I is the inactive metabolite of MLN3126.|Day 1: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng/mL||Standard Deviation|Mean
1324093|NCT02209506|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||hours||Standard Deviation|Mean
1324094|NCT02209506|Secondary|CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)|M-I is the inactive metabolite of MLN3126.|Day 1: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||liter per hour (L/hr)||Standard Deviation|Mean
1324095|NCT02209506|Secondary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng*hr/mL||Standard Deviation|Mean
1324096|NCT02209506|Secondary|AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng*hr/mL||Standard Deviation|Mean
1324097|NCT02209506|Secondary|AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng*hr/mL||Standard Deviation|Mean
1324098|NCT02209506|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||nanogram*hour per milliliter (ng*hr/mL||Standard Deviation|Mean
1324099|NCT02209506|Secondary|Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||hours||Full Range|Median
1324100|NCT02209506|Secondary|Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1324101|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by Takeda Global Research and Development Center, Inc. (TGRD). Criteria for markedly abnormal vital signs included body temperature, systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1324102|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistry, and urinalysis, during the treatment period.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1324103|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Electrocardiogram Measurements at Least Once Post Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1324104|NCT02209506|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)|A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1324105|NCT02209454|Secondary|t1/2|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h||95% Confidence Interval|Geometric Mean
1324106|NCT02209454|Secondary|Tmax|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h||Full Range|Median
1324107|NCT02209454|Primary|AUC(0-t)|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 125.00% for AUC(0-t).|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h*ng/mL||95% Confidence Interval|Geometric Mean
1324108|NCT02209454|Secondary|AUC(0-∞)|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h*ng/mL||95% Confidence Interval|Geometric Mean
1324109|NCT02209454|Primary|Cmax|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 133.00% for Cmax.|Up to 24h post-dose (pre-dose, T+5’, T+10’, T+15’, T+20’, T+30’, T+40’, T+50’, T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||ng/mL||95% Confidence Interval|Geometric Mean
1324110|NCT02209259|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS) Depression|A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|1 day||||T-score||Standard Deviation|Mean
1324111|NCT02209259|Secondary|Pain Intensity|10 point pain scale, where 0 is no pain and 10 is the most pain|1 day||||units on a scale||Standard Deviation|Mean
1324112|NCT02209259|Primary|Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity|A computerized assessment of upper extremity physical function measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.|1day||||T-score||Standard Deviation|Mean
1324113|NCT02209181|Secondary|Subject Global Evaluation|How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).|Completed at hour 12 or at time of the first rescue medication (hours post dose).|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||percentage of participants|||Number
1324114|NCT02209181|Secondary|Duration of Pain Relief After Dosing (Time to Rescue Medication)|Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given.|Completed at time of the first rescue medication (hours post dose), estimated up through Day 2|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||minutes||95% Confidence Interval|Median
1324115|NCT02209181|Secondary|Pain Relief (PAR) Scores at 24 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324116|NCT02209181|Secondary|Pain Relief (PAR) Scores at 16 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324117|NCT02209181|Secondary|Pain Relief (PAR) Scores at 12 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324118|NCT02209181|Secondary|Pain Relief (PAR) Scores at 11 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324119|NCT02209181|Secondary|Pain Relief (PAR) Scores at 10 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324120|NCT02209181|Secondary|Pain Relief (PAR) Scores at 9 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324121|NCT02209181|Secondary|Pain Relief (PAR) Scores at 8 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324122|NCT02209181|Secondary|Pain Relief (PAR) Scores at 7 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324123|NCT02209181|Secondary|Pain Relief (PAR) Scores at 6 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324126|NCT02209181|Secondary|Pain Relief (PAR) Scores at 3 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324127|NCT02209181|Secondary|Pain Relief (PAR) Scores at 2 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324128|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1.5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324129|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1 Hour Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324130|NCT02209181|Secondary|Pain Relief (PAR) Scores at 45 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324131|NCT02209181|Secondary|Pain Relief (PAR) Scores at 30 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324132|NCT02209181|Secondary|Pain Relief (PAR) Scores at 15 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324133|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324134|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324135|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324136|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324137|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324138|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324139|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324140|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324141|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324314|NCT02205801|Secondary|Post Operative Pain|Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).|At four hour after operation||||units on a scale||Standard Deviation|Mean
1324142|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324143|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324144|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324145|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324146|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324147|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324148|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324149|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324150|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324151|NCT02209181|Primary|Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)|Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).|6 Hours|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1324152|NCT02209064|Other Pre-specified|Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System|Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey|Access through end of procedure||||participants|||Number
1324153|NCT02209064|Secondary|Percentage of Participants With a Pericardial Effusion of >80ml|Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.|Access through discharge/approximately 4 days||||percentage of participants|||Number
1324154|NCT02209064|Secondary|Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System|EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.|access through procedure completion||||percentage of patients|||Number
1324155|NCT02209064|Primary|Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System|EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.|Through discharge / approx 4 days|Percentage of patients in whom epicardial access was successful using the EpiAccess system. Successful access is defined as the ability to introduce a guide wire into the epicardial space.|||percentage of patients|||Number
1324156|NCT02208349|Secondary|Overall Success|Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.|up to 24 hours, duration of the study (approximately 34 months)||||Participants|||Count of Participants
1345193|NCT01869686|Secondary|Maximum Observed Concentration (Cmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
1324157|NCT02208349|Primary|Number of Participants With Successful First Intubation Attempt (First Pass Attempt)|Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube.|less than 24 hours, collected for the duration of the study (approximately 34 months)||||Participants|||Count of Participants
1324158|NCT02208310|Secondary|Participants With at Least One Crohn's Related Emergency Department (ED) Visit|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related ED visits occurred in the 1 subject|Day 180||||participants|||Number
1324159|NCT02208310|Secondary|Change in Fatigue Measurements|"Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180||||units on a scale|||Number
1324160|NCT02208310|Secondary|Quality of Life Measure Changes|"change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).~Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180||||units on a scale|||Number
1324161|NCT02208310|Secondary|Percent With Escalation of Therapy|Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||Participants|||Count of Participants
1324162|NCT02208310|Secondary|Changes in Fecal Calprotectin|Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.|1 year|Results were not collected on any subjects||||||
1324163|NCT02208310|Secondary|Change in C-reactive Protein|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here.|Day 180||||mg/dL|||Number
1324164|NCT02208310|Secondary|Change in Modified Harvey-Bradshaw Index (HBI Without Examination)|"modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI."|Day 180||||units on a scale (0-16)|||Number
1324165|NCT02208310|Secondary|Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related surgeries occurred in the 1 subject|Day 180||||CD-related surgery occurred|||Number
1324166|NCT02208310|Secondary|Steroid Prescription Given (Dichotomous 0/1)|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred|Day 180||||Steroid prescription occurred|||Number
1324167|NCT02208310|Secondary|Crohn's Related Hospitalizations|Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||CD-related hospitalization occurred|||Number
1324168|NCT02208310|Primary|Incidence of Nephrolithiasis|Incidence of nephrolithiasis associated with hypercalcemia (>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||Participants|||Count of Participants
1324169|NCT02208310|Primary|Hypercalcemia|Hypercalcemia is presented as number of participants with Calcium >10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||Participants|||Count of Participants
1324170|NCT02208310|Primary|Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions|"Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180||||participants|||Number
1324171|NCT02207972|Secondary|Number of Participants Without Angle Adjustments in Space Success|the number of participants with successes without any readjustment of the angle in the space|immediate||||Participants|||Count of Participants
1324172|NCT02207972|Secondary|Number of Participants With Successful First Attempt|The number of participants who had first attempt success to locate the epidural space and midline position|Immediate|Pregnant patients in labor requesting neuraxial analgesia|||Participants|||Count of Participants
1324173|NCT02207972|Primary|Number of Participants With Accurate Epidural Placement|Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position|2 hours||||Participants|||Count of Participants
1324181|NCT02207803|Secondary|Exemplary Care Scale-Provide Subscale|4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.|2 months post-hospital discharge|This is patient-report only at post-test, hence it does not use the full sample.|||units on a scale||Standard Deviation|Mean
1324182|NCT02207803|Primary|Zarit Burden Interview|22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.|2 months post-hospital discharge|Data are from caregivers only, hence not the full sample.|||units on a scale||Standard Deviation|Mean
1324174|NCT02207907|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.|The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth|Baseline, 6,12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Mean
1324175|NCT02207907|Secondary|Bleeding Index at 6, 12 and 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Baseline, 6, 12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a Scale||Standard Error|Mean
1324176|NCT02207907|Secondary|Modified Gingival Index (MGI) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|Baseline, 6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Mean
1324177|NCT02207907|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks.|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|Baseline, 6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||number of gingival bleeding sites||Standard Error|Mean
1324178|NCT02207907|Primary|Modified Gingival Index (MGI) at 24 Weeks|The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|Baseline, 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Mean
1324179|NCT02207907|Primary|Number of Gingival Bleeding Sites at 24 Weeks|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|Baseline, 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.|||number of gingival bleeding sites||Standard Error|Mean
1324180|NCT02207829|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis|||Liter||Standard Error|Least Squares Mean
1324315|NCT02205801|Primary|Intraoperative Fentanyl Administration|The total amount of Fentanyl administered during the procedure will be recorded.|During the procedure||||mcg||Standard Deviation|Mean
1324183|NCT02207634|Secondary|Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score|Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Reaction Time (RTI) test assessed the cognitive domain of psychomotor speed (detecting and responding to a stimulus). Participants held down a button until a spot appeared in 1 of 5 circles on the screen. As soon as possible after the spot flashed up, the patient lifted their finger from the button and touched the circle in which the spot appeared. The RTI median 5-choice reaction time was the median duration between the onset of the stimulus and the release of the button. Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
1324184|NCT02207634|Secondary|Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score|"The CANTAB PAL test assesses visuospatial episodic memory (storing/retrieving information by associating an event with a time and place). Boxes on the screen opened up one at a time to reveal a number of patterns. Participants were asked to remember the location of each pattern. After all the boxes had been opened, each pattern was then shown in the center of the screen in a randomized order, and the patient should touch the box where they think each pattern was hidden. The PAL total errors adjusted comprised the number of errors committed by a patient plus an adjustment for the estimated number of errors the patient would have made on any stages that were not reached.~Z score represents the standardized measure of how far an individual patient deviates from the study cohort average at baseline. A higher Z score indicated better performance. The mean change from baseline averaged across all the visits is reported."|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
1324185|NCT02207634|Secondary|Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score|"Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) between-errors test assesses the cognitive domain of working memory (holding material in mind while that material is being actively processed). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found.~The SWM between-errors score is the number of times that a patient revisited a box in which a token had previously been found. The Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported."|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
1324186|NCT02207634|Primary|Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score|"Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function.~The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found.~The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported."|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
1324187|NCT02207621|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups|12 Months|The Safety Population included all randomized subjects who received at least 1 dose of study medication and was used to summarize safety variables. The safety population summarized subjects as treated for purpose of analysis. One (1) subject did not receive study drug as randomized, shown in the Participant Flow|||days||Standard Deviation|Mean
1324188|NCT02207621|Primary|Intraocular Pressure (IOP)|The primary efficacy outcome is mean intraocular pressure (IOP)|3 months|The Per Protocol (PP) population includes all subjects who did not have a major protocol violation likely to seriously affect the primary outcome of the study. This is the primary population for efficacy analyses.|||mmHg||Standard Deviation|Mean
1324189|NCT02207608|Primary|Visual Analogue Scale for Pain|1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)|Before and after six weeks of treatment (end of induction course)||||units on a scale||Standard Deviation|Mean
1324364|NCT02204579|Primary|Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).|||participants|||Number
1324190|NCT02207569|Secondary|Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe|Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.|Assessed at 30 days, 6 months, and 1 year|The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation. Only subjects with echo can be analyzed.|||percentage of participants|||Number
1324191|NCT02207569|Secondary|Hemodynamic Performance - Aortic Valve Area|Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2|Assessed at baseline, 30 days, 6 months, and 1 year|The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation - only subjects with echo can be analyzed.|||cm²||Standard Deviation|Mean
1324192|NCT02207569|Secondary|Major Vascular Complication|"Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR~>~Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR~>~Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR~>~The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR~>~Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR~>~Surgery for access site nerve injury OR~>~Permanent access related nerve injury"|Assessed at 30 days post-implantation|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system.|||percentage of participants||95% Confidence Interval|Number
1324193|NCT02207569|Secondary|Hemodynamic Performance -Mean Gradient|Mean gradient by Doppler echocardiography.|Assessed at baseline, 30 days, 6 months, and 1 year|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system. Only subjects with echo can be analyzed.|||mmHg||Standard Deviation|Mean
1324194|NCT02207569|Secondary|Percent Resheath and Recapture Success Rate|Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.|Assessed intra-procedurally|65 patients had resheath or recapture feature used during the 241 attempted procedures.|||percentage of resheath or recapture|||Number
1324195|NCT02207569|Secondary|Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days|Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure|Assessed at 30 days|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed. Additionally, these patients did NOT have ICD or PPM at the time of the index procedure.|||percentage of participants||95% Confidence Interval|Number
1324196|NCT02207569|Secondary|Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate|"Fatal bleeding (BARC type 5) OR~>~Bleeding in a critical organs, such as intracranial, intraspinal,~> intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR~>~Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR~>~Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* > (BARC type 3b)"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
1324197|NCT02207569|Secondary|Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).|"Stage 2~Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR~>~Urine output <0.5 mL/kg/h for >12 but <24 h > Stage 3 >~1) Increase in serum creatinine to ≥300% (>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR~Urine output <0.3 ml/kg/h for ≥24 h OR~>~Anuria for ≥12 h"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
1324198|NCT02207569|Secondary|Percent VARC II Combined Safety Endpoint at 30 Days|"VARC II composite safety endpoint rate includes percent freedom from the following components:~All-cause mortality~All stroke (disabling and non-disabling)~Life-threatening bleeding~Acute kidney injury: stage 2 or 3 (including renal replacement therapy).~Coronary artery obstruction requiring intervention.~Major vascular complication.~Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
1324199|NCT02207569|Secondary|Coronary Artery Obstruction Requiring Intervention.|Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
1324296|NCT02206776|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 1 Week||||Participants|||Count of Participants
1324200|NCT02207569|Secondary|Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)|Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.|Assessed at 30 days post-implantation|The safety subset includes all subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, or any monitoring line placed.|||percentage of overall patients||95% Confidence Interval|Number
1324201|NCT02207569|Primary|Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)|Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.|Assessed at 24 hours to 7 days post implantation|Subset includes all subjects who are implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system|||percentage of partcipants||95% Confidence Interval|Number
1324202|NCT02207569|Primary|Percent Device Success Rate Between 24 and 7 Day|"Percentage of patients with Device Success defined as:~Absence of procedural mortality, AND~Correct positioning of a single Evolut R valve into the proper anatomical location, AND~Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity < 3m/sec, AND~Absence of moderate or severe prosthetic valve regurgitation"|Assessed at 24 hours to seven days post implantation|All subjects implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system|||percentage of overall device success||95% Confidence Interval|Number
1324203|NCT02207569|Primary|Percentage of Patients With Disabling Stroke at 30 Days|"Stroke Diagnostic Criteria:~>~Acute episode of focal or global neurological deficit with at least 2 of the following:~change in level of consciousness >~hemiplegia, hemiparesis~numbness or sensory loss affecting 1 side >~dysphasia or aphasia~hemianopia~amaurosis fugax >~other neurological signs or symptoms consistent with stroke~2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist~3.) Confirmation of the diagnosis by at least 1 of the following:~Neurological specialist >~Neuroimaging procedure, or on clincial grounds alone > Stroke: durations of neural deficit > 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death~Defined by VARC II:~> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
1324204|NCT02207569|Primary|All-cause Mortality at 30 Days by Percent|Percentage of patients that died by any cause at 30 days|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of partcipants||95% Confidence Interval|Number
1324205|NCT02207530|Secondary|Quality of Life|"Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires:~The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3.~Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H&N35.~Function or global health status/quality of life improvement was defined as patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (an increase from baseline score ≥10). Symptom improvement was defined as 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10).~Scale improvement was defined as patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10)."|12 months|Full analysis set - included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.|||% of participants||95% Confidence Interval|Number
1324206|NCT02207530|Secondary|Overall Survival (OS)|Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status, or who were lost to follow-up.|12 months|Full analysis set - included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.|||% of participants|||Number
1324207|NCT02207530|Secondary|Progression-free Survival|"Progression status based on BICR assessments according to RECIST v1.1 at time of PFS analysis.~Progression was defined as the time from the date of first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression."|12 months|Full analysis set - included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.|||% of participants|||Number
1324208|NCT02207530|Secondary|Disease Control at 6 Months|"Disease control (DCR) at 6 months based on BICR assessments according to RECIST v1.1.~DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD):~Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following the start of study treatment.~Method 2: Patients who had a best objective response of CR or PR within 24 weeks or had demonstrated SD for a minimum interval of 16 weeks following the start of study treatment."|6 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||% of participants|||Number
1324209|NCT02207530|Secondary|Time to Onset of Response From First Dose|Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||Months||Full Range|Median
1324455|NCT02203578|Primary|Incidence of cGVHD||At 1 month after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1324210|NCT02207530|Secondary|Duration of Response|"Duration of objective response in patients with objective response based on BICR assessments according to RECIST v1.1.~Duration of response was the time from the first documentation of complete or partial response until the date of progression (which was subsequently confirmed), death, or the last evaluable RECIST assessment for patients that did not progress.~An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off."|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||Participants|||Number
1324211|NCT02207530|Secondary|Duration of Response- Participants Remaining in Response|"Participants remaining in response - based on BICR assessments according to RECIST v1.1.~An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off."|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||% of participants|||Number
1324212|NCT02207530|Secondary|Best Objective Response|"Best objective response based on BICR assessments according to RECIST v1.1. Response required confirmation after 4 weeks.~Unconfirmed complete (CR) or partial response (PR) refers to CR or PR achieved but either no confirmation assessment was performed or a confirmation assessment was performed but response was not confirmed."|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||% of participants|||Number
1324213|NCT02207530|Primary|Objective Response Rate (ORR)|"Objective response rate (per RECIST 1.1 as assessed by blinded independent central review [BICR]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR.~Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. criteria are: Complete response [CR] = disappearance of all target lesions since baseline; and partial response [PR] = at least a 30% decrease in the sum of the diameters of target lesions."|12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease at baseline according to BICR|||% of participants||95% Confidence Interval|Number
1324214|NCT02207491|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups.|3 months|Safety Population: all randomized subjects who received at least 1 dose of study medication. The safety population summarizes subjects as treated for purpose of analysis. Three (3) subjects received incorrect study medication from that to which they were randomized, shown in the Participant Flow.|||days||Standard Deviation|Mean
1324215|NCT02207491|Primary|Intraocular Pressure (IOP)|The primary efficacy outcome is mean IOP|3 months|Per-Protocol (PP) Population. The PP population includes subjects who did not have major protocol violations likely to seriously affect the primary outcome of the study. The PP population summarizes subjects as treated for purpose of analysis.|||mmHg||Standard Deviation|Mean
1324216|NCT02207478|Secondary|The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone|Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.|Up to half year||||seconds||Standard Deviation|Mean
1324217|NCT02207478|Primary|The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB|The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.|Up to half year||||participants|||Number
1324218|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324219|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324220|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324310|NCT02205814|Secondary|Change in WOMAC INDEX|The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT population (n=431).|||units on a scale||Standard Deviation|Mean
1324221|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.|During a 3 day (Days 0-2) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324222|NCT02207413|Secondary|Duration of Solicited General AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Days||Full Range|Median
1324223|NCT02207413|Secondary|Duration of Solicited Local AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Days||Full Range|Median
1324224|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>)39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324225|NCT02207413|Secondary|Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF.~Data of 2 independent groups were pooled."|During the 2 days (Day 0-Day 1) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to <5 years, with at least one vaccine administration documented.|||Subjects|||Number
1324226|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324227|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.~Fever = temperature of ≥ 38°C/100.4°F by any route"|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324228|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Fold increase||95% Confidence Interval|Geometric Mean
1324229|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
1324255|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. >50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
1324230|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
1324231|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
1324232|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Fold increase||95% Confidence Interval|Geometric Mean
1324233|NCT02207413|Secondary|Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
1324234|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
1324235|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|The analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were avail|||Titers||95% Confidence Interval|Geometric Mean
1324236|NCT02207413|Secondary|Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses.|Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
1324237|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0).~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1324294|NCT02207088|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.|Up to 24 weeks|All randomized participants who received at least one dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1324238|NCT02207413|Secondary|Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1324239|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
1324240|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1324241|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 to 35 months, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
1324242|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
1324243|NCT02207413|Primary|Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
1324244|NCT02207413|Primary|Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days)|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
1324245|NCT02207413|Primary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses.|Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
1324295|NCT02207088|Primary|Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least one dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1324456|NCT02203578|Primary|Incidence of aGVHD||At 28 days after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
1324246|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
1324247|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
1324248|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) .|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
1324249|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|"Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling.~Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination."|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
1324250|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 5-17 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.|||Days||Full Range|Median
1324251|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 3-4 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.|||Days||Full Range|Median
1324252|NCT02207413|Primary|Duration of Solicited Local AEs in Subjects Aged 3-17 Years.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Days||Full Range|Median
1324253|NCT02207413|Primary|Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
1324254|NCT02207413|Primary|Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.|||Subjects|||Number
1324365|NCT02204579|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).|||participants|||Number
1324256|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days following vaccination)|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~1 subject withdrew consent in the Influsplit Tetra_LP Adult Group and did not complete the study but was administered a study vaccine dose."|||Subjects|||Number
1324257|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
1324258|NCT02207413|Primary|Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years.|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) post-vaccination period|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~N = Number of subjects with the symptom and without the missing confirmed grade"|||Days||Full Range|Median
1324259|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
1324260|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
1324261|NCT02207400|Secondary|Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks|Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).|Baseline, 6, 12, 24 and 32 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||colony forming units per sample||Standard Deviation|Mean
1324262|NCT02207400|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.|The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1324263|NCT02207400|Secondary|Bleeding Index (BI) at 6, 12 and 24 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a Scale||Standard Deviation|Mean
1324278|NCT02207244|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324264|NCT02207400|Secondary|Modified Gingival Index (MGI)) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1324265|NCT02207400|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Baseline, 6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Number of bleeding sites||Standard Deviation|Mean
1324266|NCT02207400|Primary|Modified Gingival Index (MGI) at 24 Weeks|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1324267|NCT02207400|Primary|Number of Gingival Bleeding Sites at 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Number of bleeding sites||Standard Deviation|Mean
1324268|NCT02207244|Secondary|Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Week 24|PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab.|||Percentage of participants|||Number
1324269|NCT02207244|Secondary|Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Baseline and Week 16|PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.|||units on a scale||Standard Deviation|Mean
1324270|NCT02207244|Secondary|Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.|Week 16|Population analyzed included only randomized participants who had an ss-IGA score greater than or equal to (>=) 2 at baseline. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.|||percentage of participants|||Number
1324311|NCT02205814|Primary|Change in WOMAC A|The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.|from baseline up to 2 weeks after randomisation|The primary efficacy analysis was performed on the ITT-population (n=431).|||units on a scale||Standard Deviation|Mean
1324271|NCT02207244|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324272|NCT02207244|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324273|NCT02207244|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324274|NCT02207244|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline, Week 16|Randomized analysis set included all participants who were randomized at Week 0 and with a baseline DLQI score. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.|||units on a scale||Standard Deviation|Mean
1324275|NCT02207244|Secondary|Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.|Through Week 48|Randomized analysis set included all participants who were randomized at Week 0 and who achieved a PASI 90 response at Week 28, were re-randomized to continue guselkumab or receive placebo and with at least one PASI assessment post Week 28.|||Percentage of Participants|||Number
1324276|NCT02207244|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 24|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324277|NCT02207244|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324279|NCT02207244|Primary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324280|NCT02207244|Primary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324281|NCT02207231|Secondary|Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Week 24|PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.|||percentage of participants|||Number
1324282|NCT02207231|Secondary|Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Baseline and Week 16|PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.|||units on a scale||Standard Deviation|Mean
1324283|NCT02207231|Secondary|Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Week 16|Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (>=) 2 at baseline.|||percentage of participants|||Number
1324284|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324285|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324286|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324287|NCT02207231|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Baseline, Week 16|Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.|||units on a scale||Standard Deviation|Mean
1324288|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.|||percentage of participants|||Number
1324289|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.|||percentage of participants|||Number
1324290|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.|||percentage of participants|||Number
1324291|NCT02207231|Primary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324292|NCT02207231|Primary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
1324293|NCT02207088|Secondary|Percentage of Participants With Post-Treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last dose of study drug|All randomized participants who received at least one dose of study drug (ITT population) with HCV RNA < LLOQ at the end of treatment and completed treatment.|||percentage of participants||95% Confidence Interval|Number
1332659|NCT02056639|Secondary|Number of Subjects Experiencing Chorioamnionitis|Chorioamnionitis was recorded and analyzed for participants in each group.|Time of delivery||||Participants|||Count of Participants
1324297|NCT02206607|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration in Period 4|The safety analysis population included all participants who received at least 1 dose of open-label, sponsor-provided metformin.|||participants|||Number
1324298|NCT02206607|Secondary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||hour||Standard Deviation|Mean
1324299|NCT02206607|Secondary|Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1324300|NCT02206607|Secondary|Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||hours||Full Range|Median
1324301|NCT02206607|Secondary|Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)|Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1324302|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1324303|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324304|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324305|NCT02206607|Secondary|Maximum Observed PF-04937319 Plasma Concentration (Cmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324306|NCT02206607|Primary|Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1|MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose|The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1324307|NCT02206607|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1324308|NCT02205814|Secondary|Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate|Response based on change ≥ 20 % from baseline for EQ-5D-5L index value|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT-population (n=431).|||percentage of responders|||Number
1324309|NCT02205814|Secondary|Responder Rate According to OMERACT-OARSI Criteria|Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.|from baseline up to 6 weeks after randomisation|The secondary efficacy variables were analysed in the ITT population (n=431).|||percentage of responders|||Number
1324316|NCT02205476|Other Pre-specified|Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit|Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.|52 weeks after initial scar revision surgery in study B5301001|The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.||||||
1324317|NCT02205476|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.||||||
1324318|NCT02205476|Primary|Part B: Number of Participants With Clinical Laboratory Abnormalities|Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.||||||
1324319|NCT02205476|Primary|Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.||||||
1324320|NCT02205476|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
1324321|NCT02205476|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
1324322|NCT02205476|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
1324323|NCT02205476|Primary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
1324324|NCT02205333|Secondary|Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)|The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).|All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)|All the participants who received at least a one dose of MEDI6469.|||Participant|||Number
1324325|NCT02205333|Secondary|Terminal Phase Elimination Half-Life (T1/2)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||Day||Standard Deviation|Mean
1324754|NCT02196766|Secondary|Burning Sensation Right After Insertion (Subjective Rating)|Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline||||units on a scale||Standard Deviation|Mean
1324326|NCT02205333|Secondary|Systemic Clearance (CL)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||liter per day||Standard Deviation|Mean
1324327|NCT02205333|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||day*microgram per milliliter||Standard Deviation|Mean
1324328|NCT02205333|Secondary|Maximum Observed Serum Concentration (Cmax)|The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||microgram per milliliter||Standard Deviation|Mean
1324329|NCT02205333|Secondary|Overall Survival (OS)|The OS was the duration from the start of study treatment until death due to any cause.|From Study entry until early termination (up to 1 year)|As-treated population|||Months||95% Confidence Interval|Median
1324330|NCT02205333|Secondary|Progression-free Survival (PFS)|Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.|From Study entry until early termination (up to 1 year)|As-treated population|||Months||95% Confidence Interval|Median
1324331|NCT02205333|Secondary|Duration of Response (DOR)|Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.|From Study entry until early termination (up to 1 year)|All the participants with an OR were included.|||Days|||Number
1324332|NCT02205333|Secondary|Disease Control Rate|Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for >= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.|From study entry until early termination (up to 1 year)|As-treated population|||Percentage of participants|||Number
1324333|NCT02205333|Secondary|Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment >= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.|From study entry until early termination (up to 1 year)|As-treated population|||Percentage of participants|||Number
1324334|NCT02205333|Secondary|Best Overall Response (BOR)|Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.|From study entry until early termination (up to 1 year)|As-treated population|||Percentage of participants|||Number
1350638|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 12.|week 12||||ng/dL||Standard Deviation|Mean
1324335|NCT02205333|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs|Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
1324336|NCT02205333|Primary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs|Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
1324337|NCT02205333|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
1324338|NCT02205333|Primary|Number of Participants With Treatment-emergent Serious Adverse Events|A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
1324339|NCT02205333|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population: all the participants who received any study treatment.|||Participant|||Number
1324340|NCT02205333|Primary|Number of Participants With DLTs|The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any >=Grade 2 pneumonitis that did not resolve to <=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to <=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (>=) Grade 3 lymphopenia (unless clinically significant).|From the first dose of study treatment through 28 days after the first dose (up to 28 days)|DLT-evaluable population|||Participant|||Number
1324341|NCT02205333|Primary|Maximum Tolerated Dose (MTD) of MEDI6469|The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.|From the first dose of study treatment through 28 days after the first dose (up to 28 days)|DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.|||milligram per kilogram (mg/kg)|||Number
1324342|NCT02204748|Primary|Femoro-tibial Kinematics - Ramp Down|Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative||||degrees||Standard Deviation|Mean
1324343|NCT02204748|Primary|Femoro-tibial Kinematics - Gait|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative||||degrees||Standard Deviation|Mean
1324344|NCT02204748|Primary|Femoro-tibial Kinematics - Deep Knee Bend|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative||||degrees||Standard Deviation|Mean
1324345|NCT02204748|Secondary|Max Ground Reaction Force - Ramp Down|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative||||percentage of body weight||Standard Deviation|Mean
1324755|NCT02196766|Secondary|Stinging Sensation Right After Insertion (Subjective Rating)|Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline||||units on a scale||Standard Deviation|Mean
1352691|NCT01763918|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1324346|NCT02204748|Secondary|Max Ground Reaction Force - Gait|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative||||percentage of body weight||Standard Deviation|Mean
1324347|NCT02204748|Secondary|Max Ground Reaction Force - Deep Knee Bend|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative||||percentage of body weight||Standard Deviation|Mean
1324348|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative||||mm||Standard Deviation|Mean
1324349|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Gait|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative||||mm||Standard Deviation|Mean
1324350|NCT02204748|Primary|Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative||||mm||Standard Deviation|Mean
1324351|NCT02204657|Secondary|Hypoglycemia||28 weeks until delivery||||episodes per patient||Inter-Quartile Range|Median
1324352|NCT02204657|Primary|Glycemic Control by Measurement of HbA1c||From 28 weeks until delivery||||mean percentage||Standard Deviation|Mean
1324353|NCT02204579|Secondary|Change From Baseline in Fractional Excretion of Calcium (FECa) at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here n=number of participants analysed for specified category at the specified time points in each arm respectively.|||Fraction of excretion||Standard Deviation|Mean
1324354|NCT02204579|Secondary|Elimination Half-life (t1/2) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.|||hour||Standard Deviation|Mean
1324355|NCT02204579|Secondary|Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all randomized participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least one day of infusion.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1324356|NCT02204579|Secondary|Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.|||nanogram*hour per milliliter(ng·h/mL)||Standard Deviation|Mean
1324357|NCT02204579|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795||Baseline (Predose), and 15, 30 Minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment pharmacokinetic (PK) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.|||nanogram*hour per millilitre (ng·h/mL)||Standard Deviation|Mean
1324358|NCT02204579|Primary|Change From Baseline in Serum Parathyroid Hormone (PTH) at Specified Time Point||Baseline (Predose), 5.5 Hours, 8 Hours Postdose|Post amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||nanogram/liter (ng/L)||Standard Deviation|Mean
1324359|NCT02204579|Primary|Change From Baseline in Urinary Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||millimole/liter (mmol/L)||Standard Deviation|Mean
1324360|NCT02204579|Primary|Change From Baseline in Serum Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||millimole/liter (mmol/L)||Standard Deviation|Mean
1324361|NCT02204579|Primary|Change From Baseline in Ionised Calcium at Specified Timepoint||Baseline (Predose), 4 Hours and 8 Hours Postdose|Post-amendment pharmacodynamic (PD) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||millimole/liter (mmol/L)||Standard Deviation|Mean
1324362|NCT02204579|Primary|Number of Participants With Clinically Significant Abnormalities Related to Physical Examination||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).|||participants|||Number
1324363|NCT02204579|Primary|Number of Participants With Potentially Clinically Important Laboratory Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).|||participants|||Number
1324366|NCT02204449|Other Pre-specified|Cardiac Rehabilitation Enrollment in Site Closer to Home|A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.|8 weeks after patient is discharged from hospital||||participants|||Number
1324367|NCT02204449|Secondary|Cardiac Rehabilitation Referral|A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.|12 weeks after patient has been discharged from hospital||||participants|||Number
1324368|NCT02204449|Primary|Cardiac Rehabilitation Enrollment|A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.|12 weeks after patient is discharged from hospital||||participants|||Number
1324369|NCT02204410|Primary|Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)|"The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline and 12 Weeks|Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.|||units on a scale||Standard Deviation|Mean
1324370|NCT02204410|Primary|Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)|"The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored Never, Sometimes, or Often. Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation."|Baseline and 12 Weeks|Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.|||units on a scale||Standard Deviation|Mean
1324371|NCT02204371|Secondary|PK/PD Modeling Analysis to Characterize the Relationship Between Pazopanib Trough Concentrations and Epistaxis Frequency and Duration/Severity|A repeated categorical event per time interval PK/PD modeling analysis was planned (data permitting) to characterize the relationship between pazopanib trough concentrations and epistaxis frequency and duration/severity. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.|Weeks 3, 6, 9 and 12|Pharmacokinetic/Pharmacodynamic Population||||||
1324372|NCT02204371|Secondary|Graphical Exploration of PK/Pharmacodynamic (PD) Relationships Between Pazopanib Exposure and Selected PD|Graphical exploration of PK/PD relationships between pazopanib exposure and selected parameters was to be explored if data permitted. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.|Weeks 3, 6, 9 and 12|Pharmacokinetic/Pharmacodynamic Population||||||
1324373|NCT02204371|Secondary|Plasma Concentration of GW786034 at the Indicated Time Points|Predose (trough) blood samples were collected at weeks 3, 6, 9, and 12. Blood samples for pharmacokinetic (PK) profile were collected at pre-dose, 1, 2, 3, 4, 6 and 8 hours post dose. Area under the curve (0-tau), Concentration tau (Ctau), and maximum concentration (Cmax) following repeat administration was to be studied if data permitted.|Weeks 3, 6, 9 and 12|Pharmacokinetic Population: The Pharmacokinetic Population includes participants who had a pharmacokinetic sample obtained and analyzed. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||µg/mL||Standard Deviation|Mean
1324374|NCT02204371|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|From start of investigational product (IP) through the Study Phase (12 weeks post-dose) (assessed up to 28 weeks)|Safety Population|||Participants|||Number
1324375|NCT02204371|Secondary|Number of Participants With Urinalysis Data Meeting Criteria of Potential Clinical Concern|Protein – values of clinical concern if change from “trace” at baseline to 3+ any time on-therapy or from 0 at baseline to 2+ any time on-therapy.|Up to Week 16|Safety Population|||Participants|||Number
1324376|NCT02204371|Secondary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern|The following ECG parameters were analyzed: PR, QRS, QT, corrected QT [QTc] intervals. Criteria for clinical concern:. QT where value is > 450, QT[QTc] where value is > 450, PR where value is < 110 or > 220, QRS where value is < 75 or >110.|Up to Week 16|Safety population|||Participants|||Number
1324377|NCT02204371|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|The following laboratory parameters were analyzed in supine position after 10 minutes rest: Diastolic blood pressure (DBP), Systolic blood pressure (SBP) and Heart rate (HR). Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.|Up to Week 16|Safety Population|||Participants|||Number
1324387|NCT02204371|Primary|Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Duration of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population|||Minutes|||Number
1324756|NCT02196766|Primary|Ocular Health - Corneal Staining|Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
1324378|NCT02204371|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern|The following laboratory parameters were analyzed: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, lymphocytes; alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), total bilirubin, albumin, total protein, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, calcium, total carbondioxide, glucose, magnesium, and ferritin. Only those parameters for which at least one value of clinical concern are reported in the table. Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.|Up to Week 16|Safety Population: The Safety Population comprises of all participants who received at least one dose of study treatment. This population is based on the treatment the participant actually received.|||Participants|||Number
1324379|NCT02204371|Secondary|Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12|SF-36v2 is a generic HR QOL instrument with 36 items covering 8 subscales (SS) clustering into 2 global scores, the physical component summary score (PCS: physical functioning (PF), role physical (RP), bodily pain (BP), and general health (GH)) and mental component summary score (MCS: vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH)). All scores are normalized so that mean score for a representative US population = 50, with a standard deviation = 10. Information was used to observe a direction in overall QOL. Ranges are shown below. Higher scores represent better QOL and minimum important differences are PF, 3; RP, 3; BP, 3; GH, 2; VT, 2; SF, 3; RE, 4; and MH, 3 PCS, 2; MCS, 3. Response Consistency Index (RCI) measures the consistency of responses to individual survey responses. Lower the score the more consistent the individual responses. SF-6D Health Utility Index (HUI) Score = 0 (worst measured health state) to 1 (best measured health state).|Day (D) 1, Week (W) 6 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
1324380|NCT02204371|Secondary|Change From Baseline in Ferritin at the Indicated Time Points|Only pre-infusion ferritin values have been included in the analyses. All ferritin measurements that fall within 5 days of iron infusion date are considered post-infusion. Baseline ferritin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline is calculated as the difference between the Post dose value at indicated visit minus Baseline value. Par. were evaluated at baseline, treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and follow-up period (16, 20, 24 and 28).|Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||µg per L||Standard Deviation|Mean
1324381|NCT02204371|Secondary|Change From Baseline in the Average of the Last 3 Ferritin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)|For post-Baseline ferritin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-infusion ferritin values have been included in the analyses. Baseline ferritin value is the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of ferritin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of ferritin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.|Baseline, Week 9, Week 10.5 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.|||micrograms per liter (µg per L)||Standard Deviation|Mean
1324382|NCT02204371|Primary|Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval|Baseline PRBC transfused is defined as the number of units of PRBC transfused during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total units of PRBCs transfused during the entire dosing and follow-up period was listed by 4 week interval. Individual participant data been reported.|Over the last 4 weeks of run-in and at 4 week intervals during dosing and follow-up|Pharmacodynamic Population|||Number of units|||Number
1324383|NCT02204371|Primary|Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval|Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the entire dosing and follow-up period was listed by 4 week interval. Individual participant data has been reported.|Last 4 weeks of run-in and during last 4 weeks of dosing period|Pharmacodynamic Population|||Milligram|||Number
1324384|NCT02204371|Primary|Total Iron Intake Over the Last 4 Weeks of the Dosing Period|Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the last 4 weeks of run-in and during last 4 weeks of dosing period was listed. Individual participant data has been reported.|Last 4 weeks of run-in and during last 4 weeks of dosing period|Pharmacodynamic Population|||Milligram|||Number
1324385|NCT02204371|Primary|Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Intensity of epistaxis based on daily diaries has been reported as total gushing and total non gushing from Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population|||Number of gushing/non-gushing nosebleeds|||Number
1324386|NCT02204371|Primary|Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Frequency of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population|||Number of nosebleeds|||Number
1324411|NCT02203630|Other Pre-specified|Inotropes Used||Up to 28 days|||||||
1324412|NCT02203630|Other Pre-specified|Diuretic Agents Used||Up to 28 days|||||||
1324388|NCT02204371|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Only pre-transfusion hemoglobin values have been included in the analyses. All hemoglobin values that fall within 5 days of packed red blood cells (PRBC) transfusion are considered as post-transfusion values. Baseline hemoglobin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the Post dose value at the indicated visit minus the Baseline value. Par. were evaluated at Treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and Follow-up period (Weeks 16, 20, 24 and 28).|Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||g/L||Standard Deviation|Mean
1324389|NCT02204371|Primary|Change From Baseline in the Average of the Last 3 Hemoglobin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)|For post-Baseline hemoglobin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-transfusion hemoglobin values have been included in the analyses. Baseline hemoglobin value is the average of the last two measurements during the run-in period. . Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of hemoglobin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of hemoglobin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.|Baseline, Week 9, Week 10.5 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1324390|NCT02204371|Primary|Change From Baseline in Epistaxis Severity Score at the Indicated Time Points|The Epistaxis (nose bleeding) severity score (ESS) is a 6-item par-reported outcome measure designed to be a uniform epistaxis severity scoring system to assess the effectiveness of specific treatments on HHT-related epistaxis. Four questions document epistaxis frequency, duration, intensity and need for treatment, whereas two additional questions detail the presence of anemia and if a par has required a blood transfusion as a consequence of their epistaxis. Questions are variably weighted and results are tabulated on a 0-10 scale (0=no disease, 10 = severe disease). The minimum important difference is 0.71. Baseline is the Day1 pre-dose assessment value. Change from Baseline is calculated as the Post dose value at the indicated visit minus the Baseline value. Par were evaluated at Baseline, Treatment period (Weeks 6 and 12) and Follow-up period (Weeks 16, 20, 24 and 28). Only those par available at the indicated timepoints were analysed (specified by n=X in the category titles).|Baseline, Week 6, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population: All par. who received at least one dose of study treatment (Safety Population) and who also provided data from at least one pharmacodynamic assessment (hemoglobin, ferritin, epistaxis daily diary).|||Scores on a scale||Standard Deviation|Mean
1324391|NCT02204319|Other Pre-specified|Change in the Vulvar Pain Functional Scale Questionnaire|"Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst.~Worst reported score of functional impact =33. No functional impact = 0"|Baseline, and after last treatment visit at Week 8|women average age of 26 +/- 5.533 Years with appropriate diagnoses|||percent change||Standard Deviation|Mean
1324392|NCT02204319|Secondary|Change in Patient Specific Functional Scale Questionnaire|Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.|Baseline, and two weeks following last treatment at Week 8|women average 26+/- 5.533 Years of age who were not pregnant with appropriate diagnoses|||units on a scale||Standard Deviation|Mean
1324393|NCT02204319|Primary|Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit|"III. Q-tip testing:~. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment.~• Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS"|Average of all sites Compared from baseline visit and at 8 week (from start) follow up||||percent change from first to last Rx||Standard Deviation|Mean
1324394|NCT02204007|Secondary|Operative Time|Duration of the surgical case|time of surgery||||minutes||Full Range|Mean
1324395|NCT02204007|Primary|Acetabular Shell Version and Inclination|A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version & inclination measured in degrees) of the acetabular shell|within 2 weeks of surgery||||degrees||Full Range|Mean
1324396|NCT02203916|Secondary|Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6|Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
1324397|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic SBP Response at Week 6|SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
1324413|NCT02203630|Other Pre-specified|Anti-hypertensive Agents Used||Up to 28 days|||||||
1324398|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic DBP Response at Week 6|Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
1324399|NCT02203916|Secondary|Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)|The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
1324400|NCT02203916|Primary|Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)|The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||mmHg||Standard Error|Least Squares Mean
1324401|NCT02203786|Secondary|Winnings on Slot Machine Upon Completion of Game|Credits|15-minutes||||credits||Standard Deviation|Mean
1324402|NCT02203786|Secondary|Speed of Play on Slot Machine Game|Number of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager.|15-minutes||||individual spins/15-minutes||Standard Deviation|Mean
1324403|NCT02203786|Secondary|Betting Behaviour in Laboratory-based Slot Machine Game|Risk taking was operationally defined as credits wagered per spin (mean computed for total spins)|1x per test session (total of 4 test sessions) for duration of the study: 4 weeks (1 session/week)||||credits/spin on slot machine||Standard Deviation|Mean
1324404|NCT02203786|Secondary|Cognitive Task Performance|Response time to words (gambling, alcohol, positive affect, negative affect) as a percentage of neutral categorized words (parts of a building). This provides an index of the relative salience of stimuli from these four categories against a baseline of reaction to words with no clinical relevance or emotional valence. Smaller scores indicate faster relative response time to the test stimuli vs. neutral stimuli (i.e., greater salience)|At key points during testing: immediately after the slot machine, at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)||||percentage of neutral categorized words||Standard Deviation|Mean
1324405|NCT02203786|Secondary|Diastolic Blood Pressure (DBP)|Measure changes from baseline, especially physiologic reactivity to the slot machine and amphetamine.|At key points in testing: immediately after the slot machine game (change from session baseline), and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)(change from session baseline).||||mm Hg||Standard Deviation|Mean
1324406|NCT02203786|Primary|Subjective Reinforcement Self-report Scales|Self-reported Confidence to Refrain from Gambling (0 - 10) was assessed at test session baseline, before the slot machine and after the slot machine (Phase 1); and before amphetamine and at peak amphetamine (Phase 2). The maximum score (10) denotes complete confidence to refrain from gambling (i.e., NO urge or compulsion to gamble); the minimum score (0) denotes complete lack of confidence to refrain from gambling (i.e., overwhelming urge to gamble). Scores between 10 and 0 denote intermediate confidence to refrain from gambling with LOWER scores denoting less confidence to refrain from gambling -- i.e., GREATER urge or compulsive motivation to gamble. Scores shown are based on single item visual analogue ratings 0-10 from each participant at the specified time point. The mean (SD) of these single item ratings is presented for each sub-group.|At key points in testing: immediately after the slot machine game, and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration).||||units on a scale||Standard Deviation|Mean
1324407|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|1 week|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval)."|||rating of visual distortion symptoms||Standard Deviation|Mean
1324408|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|Baseline|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion)."|||rating of visual distortion symptoms||Standard Deviation|Mean
1324409|NCT02203721|Primary|Uncorrected Intermediate Visual Acuity|Uncorrected Intermediate Visual Acuity at 6 months.|6 months|Intent to Treat population|||LogMAR||Standard Error|Mean
1324410|NCT02203721|Primary|Distance Corrected Intermediate Visual Acuity|FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.|At 6 months|Intent to Treat Population|||LogMAR||Standard Error|Mean
1324457|NCT02203565|Primary|Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy|"Stanford Radiation Dermatitis Scoring System:~Grade Clinical finding~0 No skin change~1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection"|Baseline to up to 6 weeks after completion of therapy|Patients with complete data for analysis. While 20 patients were enrolled in the study, only 14 had data available for analysis.|||Participants|||Count of Participants
1324458|NCT02203331|Secondary|Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
1324459|NCT02203331|Secondary|Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
1324460|NCT02203331|Secondary|Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
1324461|NCT02203331|Secondary|Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
1324462|NCT02203331|Secondary|Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||units on a scale||Standard Deviation|Mean
1324463|NCT02203331|Secondary|Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.|Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||units on a scale||Standard Deviation|Mean
1324471|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
1324464|NCT02203331|Primary|Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.|Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)|The dose-response analysis was performed using the MCP-Mod method with groups containing LNG, ATZ + LNG, and Placebo. It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||units on a scale||Standard Deviation|Mean
1324465|NCT02203162|Primary|Change in Cough Reflex Sensitivity (Log C5)|Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|Baseline, 15 minutes, and 24 hours post-exposure to e-cig.||||log C5||95% Confidence Interval|Mean
1324466|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
1324467|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
1324468|NCT02203149|Primary|Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to Study Week 12 in Part 2|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 12. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants|||Number
1324469|NCT02203149|Primary|Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 16. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants|||Number
1324470|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
1324472|NCT02203149|Primary|Part 1: Percentage of Participants That Discontinued Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.|Up to Study Week 12 in Part 1|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants|||Number
1324473|NCT02203149|Primary|Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).|Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants|||Number
1324474|NCT02203149|Primary|Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.|12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)|The primary efficacy analysis was assessed in all treatment-naïve participants randomized to the Part 2 Immediate Treatment Arm who received ≥1 dose of study treatment and had any follow-up efficacy measurement. No other arms were analyzed for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1324475|NCT02203032|Secondary|Percentage of Participants With an Investigator’s Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||percentage of participants|||Number
1324476|NCT02203032|Secondary|Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||visits||Standard Deviation|Mean
1324477|NCT02203032|Secondary|Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||visits||Standard Deviation|Mean
1324478|NCT02203032|Primary|Number of Visits at Which Participants Achieved an Investigator’s Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants’ psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||visits||Standard Deviation|Mean
1324479|NCT02202980|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit||Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1324611|NCT02201420|Primary|Localization|Count of subjects with a localization by Tc 99m tilmanocept by imaging. Localization is based on the use of SPECT imaging and defined as the accumulation of radioactivity at intensity greater than background.|Up to 4 days||||participants|||Number
1324480|NCT02202980|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1324481|NCT02202980|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1324482|NCT02202980|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1324483|NCT02202980|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1324484|NCT02202785|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of MLN0264 (ATA development) using a laboratory test. Neutralizing ATA assessment was performed for ATA-positive samples only.|Pre-dose of each 21 day cycle and 30 days after last dose of study medication (Up to 7.9 months)|Safety Population included all participant who received any amount of MLN0264.|||Participants|||Number
1324485|NCT02202785|Secondary|Percentage of Participants With Reduction From Baseline in Tumor Size|The percentage of participants with the best percentage of tumor reduction from baseline in the sum of the diameter was calculated|Day 21 of each 21-day cycle, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Approximately 13.9 months)|Response-Evaluable Population was defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 post-baseline response assessment.|||percentage of participants|||Number
1324486|NCT02202785|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and sent to a laboratory to be tested for conjugated and unconjugated antibodies.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure.n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
1324487|NCT02202785|Secondary|MLN0264 Serum Concentrations|Blood samples were collected and sent to a laboratory to be tested for serum concentrations of MLN0264.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"Pharmacokinetic (PK)-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
1324488|NCT02202785|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|From the first dose through 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.|||Participants|||Number
1324489|NCT02202785|Secondary|Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|GCC H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining for a total possible H-score 0 to 600. Separate consent is required to obtain archival tumor specimens for GCC expression assessment prior to screening.|From pre-screening through end of study (approximately 18 months)|Safety population included all participants who received any amount of MLN0264.|||scores on a scale||Full Range|Mean
1324490|NCT02202785|Secondary|Serum Concentration of Monomethyl Auristatin E (MMAE)|Blood samples were collected and sent to a laboratory to be tested for MMAE.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
1324491|NCT02202785|Secondary|Cmax: Maximum Observed Serum Concentration for MLN0264||Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|Cmax was not a pre-specified secondary outcome measure. No data was collected.||||||
1324492|NCT02202785|Secondary|Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|Until death or 6 months after the last patient completes treatment—whichever occurs first (Up to 16 months)|Safety population included all participants who received any amount of MLN0264.|||days||Full Range|Median
1324612|NCT02201394|Primary|Platelet Aggregation Using Multiplate Analyzer|Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU * min.|Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dose|Patients with stable CVD|||10 AU * min||Standard Deviation|Mean
1324493|NCT02202785|Secondary|Disease Control Rate|Disease control rate is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) with a minimum of 12 weeks' duration. Investigator response is based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
1324494|NCT02202785|Secondary|Duration of Response|Duration of response is defined as the time from the date of first documentation of a Partial Response or better to the date of first documentation of disease progression or relapse based on investigator assessment using RECIST version 1.1 guidelines. Per RECIST version 1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions.|From first documented response until disease progression (Up to 16 months)|Participants from the Response-Evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment, who had a response.|||days||Full Range|Median
1324495|NCT02202785|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||days||Full Range|Median
1324496|NCT02202785|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding including measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.|||Participants|||Number
1324497|NCT02202785|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant serum chemistry, hematology, coagulation or urinalysis result. Clinically significant results are those that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.|||Participants|||Number
1324498|NCT02202785|Primary|Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (Up to 16 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
1324499|NCT02202759|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of MLN0264 (ATA development) using a laboratory test. Neutralizing ATA assessment was performed for ATA-positive samples only.|Pre-dose of each 21 day cycle and 30 days after last dose of study medication (Up to 10.7 months)|Safety Population included all participant who received any amount of MLN0264.|||participants|||Number
1324500|NCT02202759|Secondary|Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|Analysis of GCC protein expression levels in tumor tissue (fresh biopsy pretreatment and whenever a biopsy is considered medically safe and technically feasible) was performed using a semiquantitative immunohistochemistry (IHC) assay and the total GCC H-Score was determined. GCC H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining for a total possible H-score 0 to 600. Separate consent was required to obtain archival tumor specimens for GCC expression assessment prior to screening.|Approximately 20 months|Safety population included all participants who received any amount of MLN0264.|||scores on a scale||Full Range|Mean
1324501|NCT02202759|Secondary|Number of Participants With Reduction From Baseline in Tumor Size|The number of participants with the best percentage of tumor reduction from baseline in the sum of the diameter was calculated.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable Population was defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 postbaseline response assessment.|||participants|||Number
1324502|NCT02202759|Secondary|Serum Concentration of Monomethyl Auristatin E (MMAE)|Blood samples were collected and sent to a laboratory to be tested for MMAE.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
1324503|NCT02202759|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and sent to a laboratory to be tested for conjugated and unconjugated antibodies.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
1324504|NCT02202759|Secondary|MLN0264 Serum Concentrations|Blood samples were collected and sent to a laboratory to be tested for serum concentrations of MLN0264.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"Pharmacokinetic (PK)-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
1324505|NCT02202759|Secondary|Cmax: Maximum Observed Serum Concentration for MLN0264|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|Cmax was not a pre-specified secondary outcome measure. No data was collected.||||||
1324506|NCT02202759|Secondary|Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|Until death or 6 months after the last patient completes treatment—whichever occurs first (Up to 17 months)|Response-evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 postbaseline response assessment.|||days||Full Range|Median
1324507|NCT02202759|Secondary|Disease Control Rate|Disease control rate is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) with a minimum of 12 weeks' duration. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) of target lesions, taking as reference the smallest sum LD since the treatment started and no new lesions. Investigator response is based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
1324508|NCT02202759|Secondary|Duration of Response|Duration of response is defined as the time in days from the date of first documentation of a confirmed response to the date of first documentation of disease progression. Per RECIST v1.1 for target lesions and assessed by magnetic resonance imaging (MRI) - CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|From first documented response until disease progression (Up to 16.7 months)|Participants from the Response-Evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment, who had response.|||days||Full Range|Median
1324509|NCT02202759|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time Frame: Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||days||Full Range|Median
1324510|NCT02202759|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding including measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.|||participants|||Number
1324511|NCT02202759|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant serum chemistry, hematology, coagulation or urinalysis result. Clinically significant results are those that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.|From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.|||participants|||Number
1324512|NCT02202759|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug will be determined by the Investigator.|From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.|||participants|||Number
1324682|NCT02198235|Secondary|Block Duration|When did the nerve block entirely wear off?|24 hours and 48 hours after the popliteal block is given||||hours||95% Confidence Interval|Median
1324513|NCT02202759|Primary|Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (up to 17 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
1324514|NCT02202538|Secondary|Borg Rating of Perceived Exertion (BRPE) for Walking Indoors|"The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.~6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion"|8 weeks||||units on a scale||Standard Deviation|Mean
1324515|NCT02202538|Secondary|Functional Independence Measure (FIM) Score for Walking Indoors|"FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.~7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance~1: total assistance~Reference: rehabmeasures.org"|8 weeks||||units on a scale||Standard Deviation|Mean
1324516|NCT02202538|Secondary|Walking Index for Spinal Cord Injury (WISCI-II) Assessment|"Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.~0:unable~parallel bars, braces, help of 2 persons,<10m~parallel bars, braces, help of 2 persons,10m~parallel bars, braces, help of 1 person,10m~parallel bars, no braces, help of 1 person,10m~parallel bars, braces, no help,10m~walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m~8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m~Reference: rehabmeasures.org"|8 weeks||||units on a scale||Standard Deviation|Mean
1324517|NCT02202538|Primary|Percentage of Subjects That Could Don/Doff the Device Independently|The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.|8 weeks||||percentage|||Number
1324518|NCT02202538|Primary|Average Time to Don/Doff Device|Time needed for an individual to don or doff the device.|8 weeks||||minutes||Standard Deviation|Mean
1324519|NCT02202538|Primary|Timed Up and Go (TUG) Test|Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.|8 weeks||||seconds||Standard Deviation|Mean
1324520|NCT02202538|Primary|Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study|Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.|4 weeks, 8 weeks||||meters/second||Standard Deviation|Mean
1324521|NCT02202538|Primary|Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)|Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.|8 weeks||||percentage of participants|||Number
1324522|NCT02202317|Secondary|Comparison of Y-90 PET/CT to Y90 SPECT|Number of participants with a similar Y90 distribution depicted on Post Y90 delivery PET/CT and SPECT modalities, specifically comparing Y90 distribution within the treated tumors.|12 Months||||Participants|||Count of Participants
1324523|NCT02202317|Secondary|Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans.|Number of participants demonstrating a similar treatment distribution depicted by Tc99mMAA(Technetium-99m macroaggregated albumin) Brehmsstrahlung scans vs. achieved Y-90 distribution on the Internal Pair Production PET/CT scans.|12 months||||Participants|||Count of Participants
1324524|NCT02202317|Primary|Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.|Number of participants with detected extrahepatic non-target embolization. A qualitative comparison between the two modalities (Y-90 PET/CT and Brehmsstrahlung SPECT) as to the conspicuity of the abnormality would have been conducted had any participant had that result.|12 months||||Participants|||Count of Participants
1324525|NCT02202252|Other Pre-specified|Length of Hospital Stay||Participants will be followed for the duration of hospital stay, an expected average of 5 days||||days||Full Range|Median
1324526|NCT02202252|Secondary|Seroma Formation|Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..|Twenty-four hours after removal of the drains up to 4 weeks||||participants|||Number
1324527|NCT02202252|Primary|Patient Comfort Scale|Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).|Postoperative 5 days||||units on a scale||Full Range|Median
1324528|NCT02202161|Secondary|Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10)|The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14|PK population.|||Hour×ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324683|NCT02198235|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given||||units on a scale||Standard Deviation|Mean
1324529|NCT02202161|Secondary|Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses|The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin.|Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14|PK population.|||Hour||Full Range|Median
1324530|NCT02202161|Secondary|Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2).|Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14|PK population.|||Ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324531|NCT02202161|Secondary|Ratio to Baseline in Fasting Apolipoprotein B|Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Baseline (pre-dose Day -1) and Day 7, 14|Safety population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1324532|NCT02202161|Secondary|Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides|Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Baseline (pre-dose Day -1) and Day 7, 14|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1324533|NCT02202161|Secondary|PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10])|PK population. Only those participants available at the specified time points were analyzed.|Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14|PK population. Only those participants available at the specified time points were analyzed.|||Hour×ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324534|NCT02202161|Secondary|PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax)|The time at which Cmax observed was determined directly from the raw concentration-time data.|Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14|PK population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
1324535|NCT02202161|Secondary|PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax)|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided.|Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14|The PK population was used which was defined as participants from the safety population who had plasma metformin, sitagliptin, and/or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Least Squares Mean
1324536|NCT02202161|Primary|Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding|Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15.|Up to Day 15|Safety population|||Participants|||Count of Participants
1324537|NCT02202161|Primary|Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels)|GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in >=2 levels.|Day 7 and 14|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1324538|NCT02202161|Primary|Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14|The site staff classified participant’s stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.|Up to Day 15 (administered after every in-house bowel movement)|"Safety population. Only those participants available at the specified time points were analyzed. For each BSFS scale rating the Number of Participants Analyzed represents the number of participants reporting that rating not the number evaluated."|||Events|||Number
1324684|NCT02198040|Secondary|Frequency of Elbow Hemarthrosis|Number of elbow hemarthrosis in the month prior to study|Screening visit (pretreatment assessment)||||bleeding events||Standard Deviation|Mean
1324539|NCT02202161|Primary|Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14|The site staff classified participant’s stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.|Up to Day 15 (administered after every in-house bowel movement)|Safety population|||Count of bowel movements||Standard Deviation|Mean
1324540|NCT02202161|Primary|Change From Baseline in Vital Signs Assessments-heart Rate|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.|Baseline (pre-dose Day -1) and Day 7, 15|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1324541|NCT02202161|Primary|Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.|Baseline (pre-dose Day -1) and Day 7, 15|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1324542|NCT02202161|Primary|Change From Baseline in Vital Signs Assessments-temperature|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.|Baseline (pre-dose Day -1) and, Day 7, 15|Safety population. Only those participants available at the specified time points were analyzed.|||Degree Celsius||Standard Deviation|Mean
1324543|NCT02202161|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline|Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented.|Up to Day 15|Safety population|||Participants|||Count of Participants
1324544|NCT02202161|Primary|Summary of Urinalysis Data-mean pH|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline (pre-dose Day -1), Day 7 and 15|Safety population. Only those participants available at the specified time points were analyzed.|||Unit on a scale||Standard Deviation|Mean
1324545|NCT02202161|Primary|Summary of Urinalysis Data-mean Specific Gravity|Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline (pre-dose Day -1), Day 7 and 15|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1324546|NCT02202161|Primary|Number of Participants With Abnormal Urinalysis Data|Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, >30, WBC: none seen, 0-5, 1, 2, 4, <5, 6-10, 11-30, 19, >30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality.|Baseline (pre-dose Day -1), Day 7 and 15|Safety population.|||Participants|||Count of Participants
1324547|NCT02202161|Primary|Number of Participants With Abnormal Clinical Chemistry With PCI|Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: >=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: >=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: >=1.5× ULN).|Up to Day 15|Safety population.|||Participants|||Count of Participants
1324548|NCT02202161|Primary|Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI)|Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided.|Up to Day 15|Safety population|||Participants|||Count of Participants
1324549|NCT02202161|Primary|Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) >= 3× upper limit of normal (ULN) and total bilirubin >=2 × ULN (>35% direct) or ALT >=3 × ULN and international normalized ratio >1.5.|Up to 14 days (treatment period)|Safety population.|||Participants|||Count of Participants
1324550|NCT02202161|Primary|Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour])|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment.|Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours)|Safety population was used which was defined as all participants enrolled into the study who received at least one dose of study drug (including GSK2330672, GSK2330672-matched placebo, sitagliptin and metformin). Only those participants available at the specified time points were analyzed.|||Mg/deciliter||Standard Deviation|Mean
1324551|NCT02202135|Primary|Clinical Response at TOC|Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose.|7 to 20 days after last dose of study drug|Randomized|||Participant|||Number
1324552|NCT02201953|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1324553|NCT02201953|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1324554|NCT02201953|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1324555|NCT02201953|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1324556|NCT02201953|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1324557|NCT02201953|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1324558|NCT02201940|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1324559|NCT02201940|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1324560|NCT02201940|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1324561|NCT02201940|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1324562|NCT02201940|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1324563|NCT02201940|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1324564|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1324565|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1324566|NCT02201901|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1324567|NCT02201901|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1324568|NCT02201901|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1324569|NCT02201901|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1324570|NCT02201901|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1324571|NCT02201901|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|The Full Analysis Set (FAS): participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1324572|NCT02201784|Other Pre-specified|Pulse Rate, Mean Arterial Pressure, SpO2|Intragroup and intergroup variation compared|8 hours|||||||
1324573|NCT02201784|Secondary|Duration of Motor Block|Time when the Bromage score will be back to zero|8 hours||||minutes||Standard Deviation|Mean
1324574|NCT02201784|Secondary|Onset of Motor Block to Bromage3|Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).|8 hours||||minutes||Standard Deviation|Mean
1324575|NCT02201784|Secondary|Time to Maximum Cephalic Spread of Sensory Block||8 hours||||minutes||Standard Deviation|Mean
1324576|NCT02201784|Secondary|Median Maximum Level of Sensory Blockade|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|8 hours|||||||
1324577|NCT02201784|Secondary|Onset of Sensory Block at T10|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|30 minutes||||minutes||Standard Deviation|Mean
1324578|NCT02201784|Primary|Duration of Analgesia|Defined as time for first analgesic request by the patient|8 hours||||minutes||Standard Deviation|Mean
1324579|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters|ECG change data was reported as qualitative results, as per change in planned analysis. It was categorized as: normal; abnormal, not clinically significant or abnormal, clinically significant.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1324580|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate||Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||bpm|||Number
1324581|NCT02201524|Secondary|Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||degree celsius||Standard Deviation|Mean
1324582|NCT02201524|Secondary|Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||respiration per minute (resp/min)||Standard Deviation|Mean
1324583|NCT02201524|Secondary|Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||beats per minute (bpm)||Standard Deviation|Mean
1324584|NCT02201524|Secondary|Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1324585|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values|HSV DNA samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1324586|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values|CMV samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1324587|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values|EBV samples were collected and changes from baseline were evaluated by the principal investigator (PI) for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in adverse event (AEs) or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1324588|NCT02201524|Secondary|Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Reference range for measurements is 0-0.5 mg/dL and lower limit of detection is less than (<) 0.015 mg/dL. Any value <0.015 mg/dL is imputed as 0.0075 mg/dL.|Baseline, Week 1, 2, 3, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1324589|NCT02201524|Secondary|Change From Baseline in Lipid Ratios at Week 2, 4 and 8|The ratio of LDL-C/HDL-C was reported.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ratio||Standard Deviation|Mean
1324590|NCT02201524|Secondary|Change From Baseline in Fasting Lipids at Week 2, 4 and 8|Participants were required to fast 9 hours prior to sampling for lipid profile which included following parameters: low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), cholesterol, triglycerides.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1324591|NCT02201524|Secondary|Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8|The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicating more severity. Participants with response of clear and almost clear were reported. 90 percent confidence intervals were calculated using clopper-pearson (exact) method.|Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
1324592|NCT02201524|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 90 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
1324593|NCT02201524|Secondary|Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 75 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
1324685|NCT02198040|Secondary|Characteristics of the Patients|Age of patients included in teh study (years)|Screening visit (pretreatment assessment)||||years||Standard Deviation|Mean
1324594|NCT02201524|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 50 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
1324595|NCT02201524|Secondary|Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1324596|NCT02201524|Secondary|Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1324597|NCT02201524|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 4|The modified intent to treat (mITT) analysis set included all randomized participants who received at least 1 dose of the randomized study drug (PF-04965842 or placebo). Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1324598|NCT02201446|Secondary|MIF||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed|||ng/ml||Standard Deviation|Mean
1324599|NCT02201446|Secondary|IL-6||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed|||pg/ml||Standard Deviation|Mean
1324600|NCT02201446|Secondary|TNF-α||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed|||pg/ml||Standard Deviation|Mean
1324601|NCT02201446|Secondary|Death||up to 28 days||||participants|||Number
1324602|NCT02201446|Secondary|Days of Unassisted Ventilation||1 year||||days||Inter-Quartile Range|Mean
1324603|NCT02201446|Secondary|Length of Hospital Stay||1 year||||days||Inter-Quartile Range|Mean
1324604|NCT02201446|Secondary|Length of Stay in the ICU||1 year|not collected for healthy volunteers|||days||Inter-Quartile Range|Mean
1324605|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed.|||ng/ml||Standard Deviation|Mean
1324606|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 1||||ng/ml||Standard Deviation|Mean
1324607|NCT02201446|Primary|Acute Physiology and Chronic Health Evaluation (APACHE) II Scores|APACHE II scores range from 0 to 71. A higher values represent a worse outcome.|up to 28 days|not collected for healthy volunteers|||Scores on a scale||Standard Deviation|Mean
1324608|NCT02201446|Primary|Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)||up to 28 days|not collected for healthy volunteers|||ratio||Standard Deviation|Mean
1324609|NCT02201446|Primary|Number of Participants Receiving Mechanical Ventilation||up to 28 days|not collected for healthy volunteers|||participants|||Number
1324610|NCT02201420|Secondary|Time to Localization|Number of Participants with Localization at One Hour|1 hour||||participants localizing in 1 hour|||Number
1324613|NCT02201394|Primary|P2Y12 Reaction Unit (PRU)|Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.|Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose|Patients with stable CVD|||PRU||Standard Deviation|Mean
1324614|NCT02201329|Secondary|Area Under the Concentration-Time Curve of Volasertib 200 mg in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|This outcome measure presents area under the concentration-time curve of Volasertib 200 mg + Azacitidine 75 mg/m^2 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|-0.05 hours before drug administration and 0:30 (hours:minutes), 1:00, 1:30, 2:00, 3:00, 4:00, 24:30, 48:30, 96:30, 144:30 and 335:55 after drug administration.|Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1324615|NCT02201329|Secondary|Maximum Measured Concentration of the Volasertib 200 mg in Plasma (Cmax)|This outcome measure presents maximum measured concentration of Volasertib 200 mg in plasma (Cmax).|-0.05 hours before drug administration and 0:30 (hours:minutes), 1:00, 1:30, 2:00, 3:00, 4:00, 24:30, 48:30, 96:30, 144:30 and 335:55 after drug administration.|Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324616|NCT02201329|Secondary|Overall Objective Response (OR): Complete Remission (CR), Partial Remission (PR), or Marrow CR (mCR)|This outcome measure presents overall Objective Response (CR+PR+mCR). Response to treatment was evaluated according to the International Working Group (IWG) 2006 criteria. Best response was tabulated from all available data, with each patient being classified into one of the categories defined in CR, PR, mCR.|Up to 9 months.|Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.|||Participants|||Number
1324617|NCT02201329|Primary|Maximum Tolerated Dose of Volasertib|This outcome measure presents MTD of Volasertib in Combination with Azacitidine. The MTD was defined as the highest dose level at which Dose Limiting Toxicities (DLTs) were reported in not more than 1 in 6 evaluable patients during Cycle 1.|Up to 57 days.|MTD Set: This patient set included all patients in the treated set who were evaluable for MTD determination.|||mg|||Number
1324618|NCT02201329|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|"This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLT was defined as any of the following Adverse Events (AEs) considered to be related to the study drug (Volasertib and/or Azacitidine).~Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 drug-related non-haematologic toxicity.~Drug-related AEs that led to inability to deliver the full dose of the study drugs (Volasertib and/or Azacitidine) according to the assigned dose level within Cycle 1.~Absence of haematological recovery (sustained CTCAE grade ≥3 thrombocytopenia <50000/mm^3 and/or neutropenia <1000/mm^3) after completing Cycle 1 and lasting at least until Day 57 (from Day 1 of Cycle 1) despite complete marrow blast clearance on Day 29 (<5% blasts in the bone marrow.~Any other drug-related AEs that required treatment delay of ≥4 weeks between the Cycle 1 and Cycle 2 (i.e., Cycle 2 was not started until Day 57 of Cycle 1))."|Up to 57 days.|MTD Set: This patient set included all patients in the treated set who were evaluable for MTD determination.|||Participants|||Number
1324619|NCT02201056|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng*hr/mL||Standard Deviation|Mean
1324620|NCT02201056|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng*hr/mL||Standard Deviation|Mean
1324621|NCT02201056|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng/mL||Standard Deviation|Mean
1324622|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1324623|NCT02201056|Primary|Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1324624|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1324625|NCT02201056|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.|Day 1 to Day 30|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
1324626|NCT02200536|Secondary|Change in Mother's Reported Bottle-feeding Practice.|Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.|Baseline (T0) and after one month (T1)||||percentage of mothers|||Number
1324627|NCT02200536|Primary|Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.|Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.|Baseline (T0) and after one month (T1)||||percentage of mothers|||Number
1324628|NCT02200510|Primary|Change From Baseline on Disease Self-efficacy Measure at 6 Weeks|"Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 [not at all sure] to 5 [very sure]) developed by Edwards (see References).~Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome)."|baseline, 6 weeks (post-intervention)|Participants with completed baseline and post measures.|||units on a scale||Standard Deviation|Mean
1324629|NCT02200458|Primary|Number of Participants for Whom Successful Visualization of Vasculature Was Achieved||One day||||participants|||Number
1324630|NCT02200328|Secondary|Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.||||||
1324631|NCT02200328|Primary|The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.||||||
1324632|NCT02200055|Secondary|Amount of Intraoperative Fluids|The amount of IV fluids each patient received during the surgical procedure|intraoperative measurement|The population of participants with recorded data on the amount of IV fluids used during surgery|||mL||Standard Deviation|Mean
1324633|NCT02200055|Secondary|American Society of Anaesthesiologists Physical Status Classification Scale|"A classification scale to assess the fitness of patients before surgery~The ASA score is a subjective assessment of a patient’s overall physical health. The scale ranges from 1 to 5.~ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive"|preoperative|An ASA classification was recorded for each participant|||units on a scale||Standard Deviation|Mean
1324634|NCT02200055|Secondary|Study Characteristics of Participants: Body Mass Index|Body Mass Index was recorded for each study participant at baseline|baseline measurement|Baseline BMI was recorded for each participant|||kg/m^2||Standard Deviation|Mean
1324635|NCT02200055|Secondary|Urine Output|Overall urine output was collected preoperative|preoperative measurement|This population of participants recorded their urine output under preoperative conditions|||mL||Standard Deviation|Mean
1324636|NCT02200055|Secondary|Daily Fluid Balance (Intakes and Outputs)|Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period|Sum of intakes and outputs each day while inpatient, an average of 8 days|This was the final amount of participants who met all study eligibility requirements|||mL||Standard Deviation|Mean
1324637|NCT02200055|Secondary|Percent Intracellular Water Volume|Intracellular water volume was recorded for each participant before surgical procedure.|Preoperative measurement|This population includes data on participants with recorded intracellular water volume measurements|||percent of total water volume||Standard Deviation|Mean
1324638|NCT02200055|Secondary|Percent Extracellular Water Volume|Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.|6 hours postoperative measurement|This population contains data with extracellular water volume measurements taken post-operative|||percent of total water volume||Standard Deviation|Mean
1324639|NCT02200055|Secondary|Percent Intracellular Water Volume|Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.|6 hour postoperative measurement||||percent of total water volume||Standard Deviation|Mean
1324640|NCT02200055|Secondary|Percent Extracellular Water Volume|Extracellular water volume was recorded for each participant before surgical procedure.|preoperative measurement|This is the final number of participants who met all study eligibility requirements|||percent of total water volume||Standard Deviation|Mean
1324641|NCT02200055|Primary|Bioimpedance Assessment|Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.|Average measurement, in ohms, taken daily for approximately 8-10 days|This population of participants has their bioimpedance assessment taken daily for approximately 8-10 days postoperative. One average across this time frame was recorded|||ohms||Standard Deviation|Mean
1324642|NCT02200055|Primary|Bioimpedance Assessment|Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure|6 hours postoperative measurement||||ohms||Standard Deviation|Mean
1324643|NCT02200055|Primary|Bioimpedance Assessment|Bioimpedance assessment measurements were recorded for each participant before the surgical procedure|preoperative measurement|This is the population of participants with bioimpedance measurements taken preoperative|||ohms||Standard Deviation|Mean
1324757|NCT02196714|Secondary|Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose|Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
1324758|NCT02196714|Secondary|Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose|Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
1324644|NCT02199795|Secondary|Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment|"The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.~Lower times are considered to be a better outcome.~For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged."|Baseline and End of Treatment (6 weeks)||||seconds||Standard Deviation|Mean
1324645|NCT02199795|Secondary|Change in Ankle Movement Tracking Error at End of Treatment|"Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.~Lower errors are considered to be better outcomes.~For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement."|Baseline and End of Treatment (6 weeks)||||units on a scale||Standard Deviation|Mean
1324646|NCT02199795|Secondary|Change in 10-Meter Walk Test|Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.|Baseline and End of Treatment (6 weeks)||||seconds||Standard Deviation|Mean
1324647|NCT02199795|Primary|Change in Lower Extremity Fugl-Meyer Score at End of Treatment|"The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged."|Baseline and End of Treatment (6 weeks)||||units on a scale||Standard Deviation|Mean
1324648|NCT02199717|Primary|Sedentary Time|To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.|||minutes per day||Standard Deviation|Mean
1324649|NCT02199717|Primary|MVPA|To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.|||minutes per day||Standard Deviation|Mean
1324650|NCT02199652|Secondary|Insomnia Severity Index|"This is a self report scale, with 7 items scored 0-7, producing a total score range 0-28.~Higher scores are worse Score 0-7 is interpreted as no insomnia problem 8-14 subclinical insomnia 15-21 moderate insomnia 22-28 severe insomnia"|8 weeks||||units on a scale||Standard Error|Least Squares Mean
1324651|NCT02199652|Secondary|Disturbing Dreams and Nightmare Severity Index|This is a self report scale, with 5 items, producing a total score with a range from 0-37. Higher scores are worse. A score greater than 10 is considered to indicate a clinically relevant problem with nightmares and/or bad dreams|8 weeks||||units on a scale||Standard Error|Least Squares Mean
1324652|NCT02199652|Primary|Change Score for Scale for Suicide Ideation|"There will be data on the Scale for Suicide Ideation collected at the end of each week of treatment up to 8 weeks. Our apriori primary outcome is the change score in Scale for Suicide Ideation from baseline to the last observation.~This is a self report scale, with 19 items which measure present suicidality, each scored 0-2.~The total scale has a range from 0-38, with higher scores being worse"|change score from baseline to last observation, up to 8 weeks||||units on a scale||Standard Error|Least Squares Mean
1324653|NCT02199574|Primary|The Apparent Terminal Elimination Rate Constant (λz)||From time of study drug administration through Day 7 postdose||||1/hours||Standard Deviation|Mean
1324654|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))||From time of study drug administration through Day 7 postdose||||hours*ng/mL||Standard Deviation|Mean
1324655|NCT02199574|Primary|Apparent Terminal Elimination Half-life||From time of study drug administration through Day 7 postdose||||hours||Standard Deviation|Mean
1324656|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))||From time of study drug administration through Day 7 postdose||||hours*ng/mL||Standard Deviation|Mean
1324657|NCT02199574|Primary|Time to Maximum Plasma Concentration (Tmax)||From time of study drug administration through Day 7 postdose||||hours||Full Range|Median
1324658|NCT02199574|Primary|Maximum Plasma Concentration (Cmax)||From time of study drug administration through Day 7 postdose||||ng/mL||Standard Deviation|Mean
1324718|NCT02197247|Secondary|Assessment of Css,Max for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
1324659|NCT02199509|Secondary|Percent Change of the Sum of Eyes and Upper Face, Lower Face and Jaw and Tongue Subscores of the GDS Rating Scale|The Global Dystonia Severity Scale provides a severity rating for ten body regions, i.e.,1) eyes and upper face, 2) lower face, 3) jaw and tongue, 4) larynx, 5) neck, 6) shoulder and proximal arm, 7) distal arm and hand including elbow, 8) pelvis and upper leg, 9) distal leg and foot, and 10) trunk. Each body area is rated from 0 to 10, with 0 representing no dystonia present in that body area and 10 representing severe dystonia. The secondary outcome measure includes the sum of the eyes and upper face, lower face and jaw and tongue subscores of the GDS rating scale and represents the percent change from baseline to either 3 and 6 weeks or 11 and 14 weeks (representing the end of the three week titration period (3 weeks and 11 weeks) and the post-3 week period (6 weeks and 14 weeks) at the maximum tolerated dose for Levetiracetam or Placebo). The total range of these combined sub scores is 0-30, with higher scores indicating more severe dystonia and 0 indicating absence of|3, 6, 11 and 14 compared to baseline||||Percentage of change||Standard Deviation|Mean
1324660|NCT02199509|Secondary|Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of Burke-Fahn-Marsten Dystonia Rating Scale (BFM)|The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of ten body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The secondary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 3 weeks or 11 weeks (representing the end of the three week titration period up to the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia.|3 and 11 weeks compared to baseline||||percent change||Standard Deviation|Mean
1324661|NCT02199509|Primary|Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of the Burke-Fahn-Marsden (BFM) Dystonia Scale.|The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of nine body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The primary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 6 weeks or 14 weeks (representing the end of the 3 week period at the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia.|6 and 14 weeks compared to baseline||||percent change||Standard Deviation|Mean
1324662|NCT02199041|Secondary|Number of Participants With Transplant-related Morbidity|"Any patient who had adverse events listed either as probable or definite in the first 100 days post-transplant are counted as transplant-related morbidity. The cumulative incidence of transplant-related morbidity will be estimated using the Kalbfleisch-Prentice method. Deaths before day 100 are the competing risk events.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced at least one-transplant-related morbidity is provided."|100 days after transplantation||||Participants|||Count of Participants
1324663|NCT02199041|Secondary|Number of Participants With Transplant-related Mortality (TRM)|"TRM is any death in remission and related to protocol therapy. The cumulative incidence of TRM was estimated using the Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the completing events.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced TRM is provided."|100 days after transplantation||||Participants|||Count of Participants
1324664|NCT02199041|Secondary|Number of Participants With Secondary Graft Failure|"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided."|100 days after transplantation||||Participants|||Count of Participants
1324665|NCT02199041|Secondary|Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT|"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007\cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided."|100 days after transplantation||||Participants|||Count of Participants
1324666|NCT02199041|Secondary|Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT|"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007\cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided."|100 days after transplantation||||Participants|||Count of Participants
1324667|NCT02199041|Secondary|Number of Participants With Overall Survival (OS)|"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) – date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided."|One year after transplantation||||Participants|||Count of Participants
1324668|NCT02199041|Secondary|Number of Participants With Event-free Survival (EFS)|"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) – date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided."|One year after transplantation||||Participants|||Count of Participants
1324669|NCT02199041|Secondary|Number of Participants With Malignant Relapse|"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007\cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided"|One year after transplantation||||Participants|||Count of Participants
1324670|NCT02199041|Primary|Number of Participants With Neutrophil Engraftment|Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided.|Until day 42 post-transplant||||Participants|||Count of Participants
1324671|NCT02198963|Primary|Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin|"Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.~Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study."|21 days|Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites|||units on a scale||Standard Deviation|Mean
1324672|NCT02198833|Secondary|Device Specific Adverse Event Assessments|Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.|15 Days|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.||||||
1324673|NCT02198833|Secondary|Assess the Microbial Coverage and Biofilm Formation on Catheter Surface|Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.|Day 15 or upon removal of Foley Catheter|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.||||||
1324674|NCT02198833|Secondary|Time to Occurrence of Asymptomatic Bacteruria or Funguria|Urine cultures will be obtained every third day to assess for the presence of microbial growth.|15 days|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.||||||
1324675|NCT02198833|Primary|Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection|Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.|15 Days|No analysis completed due to inability to place study catheter due to persistent bacterial colonization.||||||
1324676|NCT02198430|Secondary|Measure of Weight|Measure of weight|Screening visit (pretreatment assessment)||||Kg||Standard Deviation|Mean
1324677|NCT02198430|Secondary|Assessment of Clinical Patient Variables|Hemophilia type measuring (A or B)|Screening visit||||Percentage of Participants with Hemophil|||Number
1324678|NCT02198430|Primary|Assess the Perception of Quality of Life|Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).|Screening visit|The score ranges from 0 (poor QoL) to 100 points (good perception of QoL).|||points||Standard Deviation|Mean
1324679|NCT02198430|Primary|Assess the Joint Damage|Measurement with Haemophilia Joint Health Score 2.1 (HJHS)|Screening visit|Haemophilia Joint Health Score assesses joint health in patients with hemophilia. It consists of eight dimensions: swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. The higher the score, the higher).|||points||Standard Deviation|Mean
1324680|NCT02198235|Secondary|Median Time to Requiring Oral Opioids|Did patient have pain requiring oral opioids?|24 hours after the popliteal block is given||||hours||95% Confidence Interval|Median
1324681|NCT02198235|Secondary|Numeric Rating Scale (NRS) Pain Score at Rest|Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given||||units on a scale||Standard Error|Mean
1324686|NCT02198040|Primary|Assessment of Radiological Joint Deterioration|Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)|Screening visit (pretreatment assessment)|It has made an analysis by intention to treat with the 27 patients included in the study. It has been estimated the radiological joint damage means (and standard deviation) for elbow joint.|||points||Standard Deviation|Mean
1324687|NCT02198040|Primary|Changes in the Pain Perception of Elbow|Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)||||points||Standard Deviation|Mean
1324688|NCT02198040|Primary|Changes in Biceps Strength|Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study|||points||Standard Deviation|Mean
1324689|NCT02198040|Primary|Changes in the Circumference of Arm|Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study|||cm||Standard Deviation|Mean
1324690|NCT02198040|Primary|Changes in Range of Motion of Elbow|Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study.|||degrees||Standard Deviation|Mean
1324691|NCT02197806|Primary|Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye|UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.|Baseline, Day 3|Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA|||Percentage of Patients|||Number
1324692|NCT02197481|Secondary|Total Bilirubin|serum total bilirubin on 3 postoperative day (umol/L)|3 postoperative day||||umol/l||Standard Deviation|Mean
1324693|NCT02197481|Secondary|Number of Participants Requiring a Blood Transfusion|Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively|2 days||||participants|||Number
1324694|NCT02197481|Secondary|Duration of Postoperative Hospital Stay|Time from day of operation to day of discharge|an expected average of 12 days||||days||Standard Deviation|Mean
1324695|NCT02197481|Secondary|Biliary Leakage|Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems|90 days||||participants|||Number
1324696|NCT02197481|Secondary|Morbidity||90 days||||participants|||Number
1324697|NCT02197481|Secondary|Mortality|Operative mortality was defined as any death resulting from a complication during surgery|90 days||||participants|||Number
1324698|NCT02197481|Secondary|Liver Transection Time|liver transection time was calculated from the beginning to the end of the liver resection|an expected average of 40 minutes||||min||Standard Deviation|Mean
1324699|NCT02197481|Primary|The Total Blood Loss|Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection|an expected average of 80 minutes||||ml||Standard Deviation|Mean
1324700|NCT02197455|Secondary|Mean Change in Skindex 16 Scores|Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition|3 months||||units on a scale||Full Range|Mean
1324701|NCT02197455|Primary|Mean Change in Severity of Alopecia Tool (SALT) Score|SALT score range is from 0 (no hair loss) to 100 (100% hair loss)|3 months||||percent change in SALT score||Standard Deviation|Mean
1324702|NCT02197273|Secondary|Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days||Date of discharge through 30 days following discharge||||participants|||Number
1324703|NCT02197273|Secondary|Time to Post-operative Rescue Opioids (Hours)||Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days||||hours||Full Range|Median
1324704|NCT02197273|Primary|Length of Stay in Hospital (Days)||Participants were followed for the duration of hospital stay, an expected average of 3 days||||days||Full Range|Median
1324705|NCT02197247|Secondary|Assessment of the Metabolic Ratios of AUCtau for AZ5104 and AZ7550 (MRAUCtau)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for AUCtau (MRAUCtau). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1324706|NCT02197247|Secondary|Assessment of the Metabolic Ratios of Css,Max for AZ5104 and AZ7550 (MRCss,Max)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for Css,max (MRCss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1324707|NCT02197247|Secondary|Assessment of CLss/F for Rifampicin|Rate and extent of absorption of rifampicin by assessment of CLss/F. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.||||L/h||Geometric Coefficient of Variation|Geometric Mean
1324708|NCT02197247|Secondary|Assessment of CLss/F for AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apparent plasma clearance following oral administration and multiple dosing (CLss/F). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.||||Litre per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1324709|NCT02197247|Secondary|Assessment of Css,Min for Rifampicin|Rate and extent of absorption of rifampicin by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1324710|NCT02197247|Secondary|Assessment of Css,Min for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
1324711|NCT02197247|Secondary|Assessment of Tss,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of tss,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
1324712|NCT02197247|Secondary|Assessment of Tss,Max for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of time to reach maximum plasma concentration at steady state (tss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
1324713|NCT02197247|Secondary|Assessment of AUCtau for Rifampicin|Rate and extent of absorption of rifampicin by assessment of AUCtau. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1324714|NCT02197247|Secondary|Assessment of AUCtau for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1324715|NCT02197247|Secondary|Assessment of AUCtau for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1324716|NCT02197247|Secondary|Assessment of AUCtau for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1324717|NCT02197247|Secondary|Assessment of Css,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of Css,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1324719|NCT02197247|Secondary|Assessment of Css,Max for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
1324720|NCT02197247|Secondary|Assessment of Css,Max for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of Css,max. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
1324721|NCT02197247|Primary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval for AZD9291 After Dosing Alone and in Combination With Rifampicin (AUCtau)|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 following AZD9291 and rifampicin at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM * hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
1324722|NCT02197247|Primary|Assessment of Maximum Plasma Concentration for AZD9291 After Dosing Alone and in Combination With Rifampicin (Css,Max)|Rate and extent of absorption of AZD9291 by assessment of maximum plasma concentration at steady state (Css,max). AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
1324723|NCT02197234|Secondary|AUC(0-t) of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by assessment of area under the plasma concentration time curve from time zero to last quantifiable dose|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng.h/mL||Full Range|Geometric Mean
1324724|NCT02197234|Secondary|AUC of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng.h/mL||Full Range|Geometric Mean
1324725|NCT02197234|Secondary|Cmax of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of maximum plasma simvastatin acid concentration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng/mL||Full Range|Geometric Mean
1324726|NCT02197234|Secondary|CL/F of Simvastatin|Rate and extent of absorption of simvastatin by assessment of apparent clearance following oral administration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||L/h||Full Range|Geometric Mean
1324727|NCT02197234|Secondary|Tmax of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by time to Cmax|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||hours||Full Range|Median
1324728|NCT02197234|Primary|AUC of Simvastatin|Pharmacokinetics of simvastatin by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng.h/mL||Full Range|Geometric Mean
1324729|NCT02197234|Primary|Cmax of Simvastatin|Pharmacokinetics of simvastatin by assessment of maximum plasma simvastatin concentration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng/mL||Full Range|Geometric Mean
1324730|NCT02197130|Secondary|Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: “Compared to your subject’s condition at the beginning of treatment, how much has your subject changed?”. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. n is the number of evaluable participants in each visit.|Week 13 & Week 26|All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements will not contribute to the analysis, except in the description of the baseline values.|||units on a scale||Standard Deviation|Mean
1324731|NCT02197130|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit|The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.n is the number of evaluable participants in each visit|||participants|||Number
1324732|NCT02197130|Secondary|Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.|The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The Total Maximum Chorea (TMC) was a subset of the TMS assessment. It was composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment was rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. n is the number of evaluable subjects in each visit.|Baseline, Week 13, Week 26|All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.|||units on a scale||Standard Deviation|Mean
1324733|NCT02197130|Secondary|Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). EPS were reported AEs of dystonia and akathisia.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
1324734|NCT02197130|Secondary|Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)|Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval (Fridericia's correction) increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval (Fridericia's correction) increase from baseline change >=60 msec.|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
1324735|NCT02197130|Secondary|Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)|The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia’s formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia’s correction) >=500 msec|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
1324736|NCT02197130|Secondary|Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)|The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP >= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP >=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP >=20 mmHg|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
1324737|NCT02197130|Secondary|Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)|The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (>=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP >= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP >=20 mmHg; Criterion D: maximum increase from baseline in standing DBP >=20 mmHg|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
1324738|NCT02197130|Secondary|Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)|Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (<) 90 millimeter of mercury(mmHg); Criterion B: standing SBP < 90 mmHg; Criterion C: supine DBP <50 mmHg; Criterion D: standing DBP <50 mmHg; Criterion E: supine pulse rate < 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (>)120 BPM; Criterion G: standing pulse rate < 40 beats per minute(BPM); Criterion H: standing pulse rate >120 BPM;|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
1324752|NCT02196766|Primary|Ocular Health - Limbal Redness|Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
1324753|NCT02196766|Primary|Ocular Health - Conjunctival Redness|Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
1324739|NCT02197130|Secondary|Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).|Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
1324740|NCT02197130|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).|Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
1324741|NCT02197130|Secondary|Number of Participants With Serious Adverse Events|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
1324742|NCT02197130|Secondary|Number of Participants With Adverse Events|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
1324743|NCT02197130|Secondary|Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria|The criteria for temporary study suspension was as follow: Criterion A: WBC count <=3000 cells/mm3 but >= 2000 cells/mm3 or ANC <= 1500 cells/mm3 but >= 1000 cells/mm3; Criterion B: WBC <= 2000 cells/mm3 or ANC <= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC <= 500 cells/mm3|Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
1324744|NCT02197130|Primary|Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.|The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.|Baseline, Week 26|All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.|||units on a scale||Standard Deviation|Mean
1324745|NCT02197065|Secondary|Peri-operative Rise in Interleukin-6 (IL-6) Levels|The change in the level of IL-6 from baseline to POD2 in 16 arthroplasty patients randomized (1:1) to atorvastatin 40mg versus placebo.|Change from preoperative to postoperative day 2|16 arthroplasty patients|||pg/mL||Inter-Quartile Range|Median
1324746|NCT02197065|Primary|Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)|The change in the level of hs-CRP from baseline to POD2 in 20 orthopedic patients randomized (1:1) to atorvastatin 40mg versus placebo.|Change from preoperative to post-operative day 2||||mg/L||Inter-Quartile Range|Median
1324747|NCT02197065|Primary|Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I|The percentage of orthopedic patients with a ≥ 10 pg/mL rise in high-sensitivity cardiac troponin I (hs-cTnI) from baseline pre-operatively to post-operative day (POD)2|change from preoperative to postoperative day 2|20 orthopedic surgery patients.|||percentage of patients|||Number
1324748|NCT02196922|Secondary|Quality of Life|Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)|Baseline and Day 90||||units on a scale||Full Range|Mean
1324749|NCT02196922|Primary|Emergency Department Visits|Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period|Days 0-90|Intention to Treat population (all participants to COM or TSM)|||participants group mean ED visits/90 day||Standard Deviation|Mean
1324750|NCT02196922|Primary|Hospitalizations|Number of hospitalizations during the 90 day observation period|Baseline and Day 90|Intention to treat population (all participants who are randomized to either COM or TSM.|||participant mean hospitalizations/90 day||Standard Deviation|Mean
1324751|NCT02196766|Primary|Ocular Health - Papillary Conjunctivitis|Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
1324766|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)|12 hours|Safety Population|||mL/min/1.73m2||Standard Deviation|Mean
1324767|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||μmol/L||Standard Deviation|Mean
1324768|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||mmol/L||Standard Deviation|Mean
1324769|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||g/L||Standard Deviation|Mean
1324770|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||IU/L||Standard Deviation|Mean
1324771|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)|12 Hours|Safety Population|||10^12cells/L||Standard Deviation|Mean
1324772|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)|12 Hours|Safety Population|||pg/cell||Standard Deviation|Mean
1324773|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)|12 Hours|Safety Population|||fL||Standard Deviation|Mean
1324774|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population|||g/L||Standard Deviation|Mean
1324775|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population|||Ratio||Standard Deviation|Mean
1324776|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population|||10^9cells/L||Standard Deviation|Mean
1324777|NCT02196714|Primary|Lambda z|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||1/h||Full Range|Mean
1324778|NCT02196714|Primary|Lambda z|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||1/h||Full Range|Mean
1324779|NCT02196714|Primary|Vd/F|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L||Full Range|Mean
1324780|NCT02196714|Primary|Vd/F|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L||Full Range|Mean
1324781|NCT02196714|Primary|CL/F|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L/h||Full Range|Mean
1324782|NCT02196714|Primary|CL/F|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L/h||Full Range|Mean
1324783|NCT02196714|Primary|T 1/2|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h||Full Range|Mean
1324784|NCT02196714|Primary|T 1/2|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h||Full Range|Mean
1324785|NCT02196714|Primary|Tmax|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)|Day 1|Pharmacokinetic Population|||h||Full Range|Mean
1324786|NCT02196714|Primary|Tmax|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)|Day 1|Pharmacokinetic Population|||h||Full Range|Mean
1324787|NCT02196714|Primary|AUC 0-∞|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
1324788|NCT02196714|Primary|AUC 0-∞|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
1324789|NCT02196714|Primary|AUC 0-t|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
1324790|NCT02196714|Primary|AUC 0-t|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
1324791|NCT02196714|Primary|AUC 0-12|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
1324792|NCT02196714|Primary|AUC 0-12|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
1324793|NCT02196714|Primary|Cmax|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||pg/mL||Full Range|Mean
1324794|NCT02196714|Primary|Cmax|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||pg/mL||Full Range|Mean
1324795|NCT02196701|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24||Baseline and week 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||mg/L||Standard Error|Least Squares Mean
1324796|NCT02196701|Secondary|Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324797|NCT02196701|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percent change||Standard Error|Least Squares Mean
1324798|NCT02196701|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||units on a scale||Standard Error|Least Squares Mean
1324799|NCT02196701|Secondary|Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|"The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.~A decrease in BSA affected by psoriasis indicates improvement."|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percent change||Standard Error|Least Squares Mean
1324800|NCT02196701|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|"The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.~A decrease in BSA affected by psoriasis indicates improvement."|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percentage of body surface area||Standard Error|Least Squares Mean
1324801|NCT02196701|Secondary|Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:~0 (Cleared): No evidence of scaling, erythema, or plaque elevation;~1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;~2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;~3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;~4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;~5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.~The percentage of participants achieving a score of clear (0) or minimal (1) is reported."|Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324802|NCT02196701|Secondary|Percent Change From Baseline in PASI Score|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percent change||Standard Error|Least Squares Mean
1324803|NCT02196701|Secondary|Change From Baseline in PASI Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||units on a scale||Standard Error|Least Squares Mean
1324804|NCT02196701|Secondary|Percentage of Participants Who Achieved a PASI 100 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1325587|NCT02178787|Primary|To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).|CO2 reactivity will be measured as the slope of regression between TCD_BFV and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.|one year||||cm/sec||Standard Error|Mean
1324805|NCT02196701|Secondary|Percentage of Participants Who Achieved a PASI 90 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324806|NCT02196701|Secondary|Percentage of Participants Who Achieved a PASI 75 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324807|NCT02196701|Secondary|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324808|NCT02196701|Secondary|Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time|"Participants were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied"|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX and with available data at each time point..|||Participants|||Count of Participants
1324809|NCT02196701|Secondary|Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time|"Study investigators were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject’s current treatment regimen? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied"|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX with available data at each time point.|||Participants|||Count of Participants
1324810|NCT02196701|Secondary|Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time|"Participants were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Baseline, week 8 and week 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324811|NCT02196701|Secondary|Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time|"Study investigators were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject’s current treatment regimen? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Baseline, week 8 and week 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324812|NCT02196701|Primary|Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment|"Participants were asked to complete the following questionnaire at week 16:~Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Week 16|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324813|NCT02196701|Primary|Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment|"Study investigators were asked to complete the following questionnaire at week 16:~Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject’s current treatment regimen? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Week 16|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
1324814|NCT02196675|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||days||Standard Deviation|Mean
1324815|NCT02196675|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||milliliters||Standard Deviation|Mean
1324816|NCT02196675|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.|||days||Standard Deviation|Mean
1324817|NCT02196675|Secondary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|ll subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
1324818|NCT02196675|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
1324819|NCT02196506|Secondary|Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulations With Anxious Distress as Specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).|To assess the change from end of Phase A (Week 8) to end of Phase B (Week 14) in MADRS Total Score for the subpopulations with anxious distress as specified in DSM-V. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.|From baseline (end of Phase A [Week 8]) to week 14|Subpopulation of Anxious Distress Sample: Comprised of all participants in the Efficacy Sample who had anxious distress as specified in DSM-V.|||Units on a scale||Standard Error|Least Squares Mean
1324820|NCT02196506|Secondary|Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulation With <25% Improvement From Baseline of Phase A to End of Phase A in MADRS Total Score|To assess the change from end of Phase A (Week 8 visit) to end of Phase B (Week 14 visit) in MADRS Total Score for the subpopulation with < 25% improvement from baseline of Phase A (Week 0) to end of Phase A (Week 8) in MADRS Total Score. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.|From baseline (end of Phase A [Week 8]) to week 14|Subpopulation of <25% Improvement Sample: Comprised of all participants in the Efficacy Sample who had <25% improvement at the end of Phase A in MADRS Total Score.|||Units on a scale||Standard Error|Least Squares Mean
1324821|NCT02196506|Secondary|Change in the Sheehan Disability Scale (SDS) From Baseline to End of Treatment|To assess the change in the Sheehan Disability Scale (SDS) Score (the mean of 3 individual item scores) from Baseline (End of Phase A [Week 8]) to Week 14 (End of Phase B). SDS was a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life, and family life/home responsibility. Each item was scored using a scale of 0 to 10 (a higher score indicates symptoms have disrupted work, social life, and family life/home responsibility extremely). The maximum total score was 30; 0 = not at all, to 30 = extremely.|From baseline (end of Phase A [Week 8]) to week 14|The primary analysis was performed on Efficacy Sample which included all randomized participants who took at least one dose of trial medication in Phase B and who have both an end of Phase A (Week 8) and at least one post-randomization MADRS Total Score during Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1324822|NCT02196506|Primary|Change in the Montgomery-Asberg Depression|To assess the change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Baseline (End of Phase A [Week 8]) to Week 14. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The rater decided whether the rating lied on predefined scale steps (0, 2, 4, 6) or between them (1, 3, 5). The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.|From baseline (end of Phase A [Week 8]) to week 14|The primary analysis was performed on Efficacy Sample which included all randomized participants who took at least one dose of trial medication in Phase B and who have both an end of Phase A (Week 8) and at least one post-randomization MADRS Total Score during Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1324823|NCT02196259|Primary|Functional Connectivity|"The imaging experiments and analysis of subject-specific data will lead to maps corresponding to separate measures: resting state functional connectivity maps. The outcome of interest is whether ketamine reduces functional connectivity between the anterior (subgenual anterior cingulate corte, sgACC) and posterior regions (posterior cingulate cortex, PCC) of the default mode network. This is the z-score of the functional connectivity correlation.~Timepoints for Initial fMRI were: Time 1:Immediately before Infusion, Time 2: After washout (Approx. 40 min after end of infusion).~Timepoints for Depression were: Time 1: 1 Day before Infusion, Time 2: 1 Day after Infusion"|8 minutes scans, acquired between 1 day and 3 days (see above)|Primary outcome measure is functional connectivity as measured using the MRI scans, which is only in the Initial MRI and Depression Arms.|||z score||Standard Error|Mean
1324824|NCT02196168|Secondary|Progression Free Survival|Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.|Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 months||||months||95% Confidence Interval|Median
1324825|NCT02196168|Secondary|Progression Free Survival|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (20% increase in the sum of the longest diameter of target lesions or a measurable increase in a non-target lesion, or the appearance of new lesions) or death, whichever occurs first.|Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months||||months||95% Confidence Interval|Median
1324826|NCT02196168|Secondary|Overall Survival|Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.|12 months||||months||95% Confidence Interval|Median
1324827|NCT02196168|Secondary|Levels of Predictive Biomarkers|Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.|Up to day 4 of course 1|No data are available as decision was made by PI not to do the analysis due to small number of patients.||||||
1324828|NCT02196168|Secondary|Levels of Pharmacodynamic Biomarkers|Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.|Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4|No data are available as decision was made by PI not to do the analysis due to small number of patients||||||
1324829|NCT02196168|Secondary|Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug|Up to 1 year||||adverse events|||Number
1324830|NCT02196168|Primary|Overall Response Rate (Complete Plus Partial Response) Using RECIST Criteria v1.1|Per Response Evaluation Criteria in solid Tumors (RECIST1.1) Target lesions are assessed as Complete Response(CR), Disappearance of all target lesions; Partial Response (PR),30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), At least a 20% increase (minimum 5 mm) from smallest sum (nadir); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Nontarget lesions are assessed as Complete Response (CR), Disappearance of all non-target lesions; Non-CR/Non-PD, Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; Progressive Disease (PD),Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Overall Response(OR); PR=CR+non-CR/non-PD,SD=SD+non-PD; PD=PD+presence of any non-target lesions|Up to 1 year||||Participants|||Number
1324831|NCT02196077|Secondary|Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment||Visit 12-13 (7 days)|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Puffs||95% Confidence Interval|Least Squares Mean
1324832|NCT02196077|Secondary|Transition Dyspnea Index (TDI) Focal Score on Day 29|Min/Max Range of TDI scale -9 (major deterioration) to +9 (major improvement)|Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods.|||Index||Full Range|Least Squares Mean
1324833|NCT02196077|Secondary|Forced Vital Capacity (FVC) AUC0-12 on Day 29||Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
1324834|NCT02196077|Secondary|Peak Change From Baseline in FEV1 on Day 1||Day 1|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
1324835|NCT02196077|Secondary|Peak Change From Baseline in FEV1 (in Liters) Day 29||Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
1324836|NCT02196077|Secondary|Peak Change From Baseline in FEV1 (in Liters) Day 15||Day 15|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
1324837|NCT02196077|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days||Over 28 days|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
1324838|NCT02196077|Primary|FEV1 AUC0-12 on Day 29|Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)|Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods.|||Liters||95% Confidence Interval|Least Squares Mean
1324839|NCT02195986|Secondary|Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo|Evaluation and comparison between Estradiol Vaginal Cream, Estrace®, and Placebo treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.|Day 8|The Intent-to-treat (ITT) population was used for the Superiority Analysis which consisted of all randomized subjects that used at least one dose of Estradiol Vaginal Cream, Estrace®, or Placebo and returned for at least one post-baseline visit|||Participants|||Count of Participants
1324840|NCT02195986|Secondary|Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence|Evaluation and comparison between Estradiol Vaginal Cream and Estrace® treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.|Day 8|The Per Protocol population was used for the secondary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed secondary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation|||Participants|||Count of Participants
1324841|NCT02195986|Primary|Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo|"Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8.~A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5."|Study Day 8|The Intent-to-treat (ITT) population was used for the comparison of active treatments versus placebo analysis which consisted of all randomized subjects that used at least one dose of Test, Reference or Placebo and returned for at least one post-baseline visit.|||Participants|||Count of Participants
1324842|NCT02195986|Primary|Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence|"Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8.~A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5."|Study Day 8|The Per Protocol population was used for the primary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed primary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation|||Participants|||Count of Participants
1324843|NCT02195713|Primary|Urine Output of SOC Device Versus Accuryn|Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.|2 - 5 days||||Patients with airlocks||95% Confidence Interval|Number
1324844|NCT02195700|Secondary|Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis|"This outcome is similar to the primary outcome except that AIMS was read locally.~AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. This outcome reports the local reading of AIMS data.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement.~A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point (weeks 2, 4, 6, 9, and 12), treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate."|Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12|modified intent to treat analysis. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading.|||units on a scale||Standard Error|Least Squares Mean
1324845|NCT02195700|Secondary|Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12|"Response level represents the % improvement in AIMS from baseline. AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia).~Patients with a missing AIMS score were considered to be AIMS nonresponders."|Day 0 (Baseline), Week 12|modified intent to treat population.|||percentage of participants|||Number
1324846|NCT02195700|Secondary|Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis|"AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative percent change from baseline score indicates improvement.~The MMRM model includes fixed effects for treatment, time point (weeks 2, 4, 6, 9, 12), treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. Patient is a random effect."|Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12|modified intent to treat population. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading.|||percentage change||Standard Error|Least Squares Mean
1324856|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
1324847|NCT02195700|Secondary|Participants With Adverse Events for the Overall Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population|||Participants|||Count of Participants
1324848|NCT02195700|Secondary|Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24)|The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains are evaluated in the CDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 (no impairment) to 96 (severe impairment). Negative change from baseline scores indicate improvement.|Day 0 (Baseline), Week 12 with last observation carried forward|modified intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1324849|NCT02195700|Secondary|Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)|The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (–3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as “much improved” or “very much improved” at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not “much improved” or “very much improved” at the week 12 visit, were considered treatment failures.|Week 12|modified intent to treat population|||percentage of participants|||Number
1324850|NCT02195700|Secondary|Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)|The CGIC is a single-item questionnaire that asks the investigator to assess a patient’s TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (–3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as “much improved” or “very much improved” at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not “much improved” or “very much improved” at the week 12 visit, were considered treatment failures.|Week 12|modified intent to treat population|||percentage of participants|||Number
1324851|NCT02195700|Primary|Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis|"AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement.~A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point, treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. An unstructured covariance model was used."|Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12|The Modified ITT (mITT) Population was defined as all patients in the ITT Population who received study drug and had at least 1 centrally read post-baseline assessment of the AIMS from at least 1 scheduled post-baseline time point. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading.|||units on a scale||Standard Error|Least Squares Mean
1324852|NCT02195687|Secondary|Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
1324853|NCT02195687|Secondary|Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire|Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.|Baseline, Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline|||Percentage of Subjects|||Number
1324854|NCT02195687|Secondary|Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)|Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
1324855|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
1324881|NCT02195414|Secondary|OCT Endpoint||5 years||2020-10-31|10/2020||||
1324857|NCT02195687|Primary|Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
1324858|NCT02195583|Secondary|Percentage Comparative Acid Resistance (% CAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||Percentage of CAR||Standard Error|Least Squares Mean
1324859|NCT02195583|Secondary|Percentage Net Acid Resistance (% NAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||Percentage of NAR||Standard Error|Least Squares Mean
1324860|NCT02195583|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||microgram per square centimeter(μg/cm^2)||Standard Error|Least Squares Mean
1324861|NCT02195583|Primary|Percentage Surface Microhardness Recovery (% SMHR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.|Baseline to 4 hours|The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||Percentage of SMHR||Standard Error|Least Squares Mean
1324862|NCT02195427|Secondary|Number of Subjects Receiving Re-treatment||Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow)|||Participants|||Count of Participants
1324863|NCT02195427|Secondary|Number of Subjects Receiving Touch-up Treatment.||Week 2||||Participants|||Count of Participants
1324864|NCT02195427|Secondary|Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)||Week 2||||mL||Standard Deviation|Mean
1324865|NCT02195427|Secondary|Subject’s Satisfaction Score|Subjective 5-point scale with 1 being ‘very satisfied’ and 5 being ‘very dissatisfied’|Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
1324866|NCT02195427|Secondary|Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire|"The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient’s perspective.~FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').~The subject was instructed as follows: “These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:”, and provided response.~How deep your nasolabial fold are?~How your nasolabial folds look when your face is relaxed (still)?~How old your nasolabial folds make you look?~How your nasolabial folds look when you smile?~How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome."|Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
1324882|NCT02195414|Secondary|OCT Endpoint||2 years||2017-10-31|10/2017||||
1324883|NCT02195414|Secondary|OCT Endpoint|proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.|6 months||2016-04-30|04/2016||||
1324884|NCT02195414|Secondary|Angiographic Endpoint||5 years||2020-10-31|10/2020||||
1324885|NCT02195414|Secondary|Angiographic Endpoint||2 years||2016-10-31|10/2016||||
1324867|NCT02195427|Secondary|"Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale."|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse that evaluate the aesthetic improvement from baseline.~GAI was assessed using the baseline photograph. Subjects will be instructed: Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale.~Each side of the face was assessed independently."|Weeks 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
1324868|NCT02195427|Secondary|"Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE)."|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse that evaluate the aesthetic improvement from baseline.~GAI was assessed using the baseline photograph. Each side of the face was assessed independently."|Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
1324869|NCT02195427|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
1324870|NCT02195427|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
1324871|NCT02195427|Secondary|Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI|TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being ‘absent’ and 5 being ‘extreme’ TI = Treating Investigator|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||WSRS Delta from V1||Standard Deviation|Mean
1324872|NCT02195427|Secondary|Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE|TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being ‘absent’ and 5 being ‘extreme’ BLE = Blinded Live Evaluator|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||WSRS Delta from V1||Standard Deviation|Mean
1324873|NCT02195427|Secondary|Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).|VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain|During Injection and 5, 15, 30 minutes post-injection|"1 subject randomized to the GA/J cohort received injections with DL/J and was placed in the DL/J cohort for safety evaluation; So: N=75 for DL/J SAFT population and N=72 for GA/J SAFT population.~Number of patients after touch-up treatment are based on number of patients receiving Touch-up treatment (GA N=47/J-GA N=49/DL N=50/J-DL N=53)"|||VAS score||Standard Deviation|Mean
1324874|NCT02195427|Secondary|Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).|"The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).~The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and other.~The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate other if the subject experienced a sign/symptom that is not listed.~The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)"|During 14 days after initial treatment (D0) and touch-up (2 weeks)|"1 subject randomized to the GA/J cohort received injections with DL/J and was placed in the DL/J cohort for safety evaluation; So: N=75 for DL/J SAFT population and N=72 for GA/J SAFT population.~Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (GA N=47/J-GA N=49/DL N=50/J-DL N=53)"|||Participants|||Count of Participants
1324875|NCT02195427|Primary|Non-inferiority of the Delta of TEOSYAL® RHA GA and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE).|TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being ‘absent’ and 5 being ‘extreme’ BLE = Blinded Live Evaluator|Baseline and 24 weeks after last treatment||||units on a scale||97.5% Confidence Interval|Mean
1324876|NCT02195414|Secondary|MSCT Endpoint||3 years||2018-10-31|10/2018||||
1324877|NCT02195414|Secondary|MSCT Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|1 year||2016-10-31|10/2016||||
1324878|NCT02195414|Secondary|IVUS Endpoint||5 years||2020-10-31|10/2020||||
1324879|NCT02195414|Secondary|IVUS Endpoint||2 years||2017-10-31|10/2017||||
1324880|NCT02195414|Secondary|IVUS Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|6 months||2016-04-30|04/2016||||
1324886|NCT02195414|Secondary|Angiographic Endpoint|In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).|6 months||2016-04-30|04/2016||||
1324887|NCT02195414|Secondary|Scaffold Thrombosis||5 years||2020-10-31|10/2020||||
1324888|NCT02195414|Secondary|Scaffold Thrombosis||4 years||2019-10-31|10/2019||||
1324889|NCT02195414|Secondary|Scaffold Thrombosis||3 years||2018-10-31|10/2018||||
1324890|NCT02195414|Secondary|Scaffold Thrombosis||2 years||2017-10-31|10/2017||||
1324891|NCT02195414|Secondary|Scaffold Thrombosis||1 year||2016-10-31|10/2016||||
1324892|NCT02195414|Secondary|Scaffold Thrombosis||6 months||2016-04-30|04/2016||||
1324893|NCT02195414|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤1day), subacute (>1day ≤30 days) and late (>30 days).~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days."|30days||||participants|||Number
1324894|NCT02195414|Secondary|Acute Success (Clinical Device and Clinical Procedure)|"Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).~Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success."|acute||||participants|||Number
1324895|NCT02195414|Secondary|Patient Oriented Composite Endpoint||5 years||2019-10-31|10/2019||||
1324896|NCT02195414|Secondary|Patient Oriented Composite Endpoint||4 years||2018-10-31|10/2018||||
1324897|NCT02195414|Secondary|Patient Oriented Composite Endpoint||3 years||2017-10-31|10/2017||||
1324898|NCT02195414|Secondary|Patient Oriented Composite Endpoint||2 years||2016-10-31|10/2016||||
1324899|NCT02195414|Secondary|Patient Oriented Composite Endpoint||1 year||2016-10-31|10/2016||||
1324900|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|6 months||2016-04-30|04/2016||||
1324901|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|30 days||||participants|||Number
1324902|NCT02195414|Secondary|Target Lesion Failure||5 years||2020-10-31|10/2020||||
1324903|NCT02195414|Secondary|Target Lesion Failure||4 years||2019-10-31|10/2019||||
1324904|NCT02195414|Secondary|Target Lesion Failure||3 years||2018-10-31|10/2018||||
1324905|NCT02195414|Secondary|Target Lesion Failure||2 years||2017-10-31|10/2017||||
1324906|NCT02195414|Secondary|Target Lesion Failure||1 year||2016-10-31|10/2016||||
1324907|NCT02195414|Secondary|Target Lesion Failure|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|6 months||2016-04-30|04/2016||||
1324908|NCT02195414|Primary|Target Lesion Failure(TLF)|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|30 days||||participants|||Number
1324909|NCT02195011|Secondary|Median Overall Survival|Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive.|up to 18 months|Includes all patients who received treatment.|||Months||95% Confidence Interval|Median
1324910|NCT02195011|Secondary|Median Progression-Free Survival|Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.|At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months.|Includes all patients who received treatment.|||months||95% Confidence Interval|Median
1324911|NCT02195011|Secondary|Number of Patients With an Objective Response (CR or PR)|Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.|At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months|Includes all patients who have received study treatment.|||Participants|||Count of Participants
1324912|NCT02195011|Primary|The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety|A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.|up to 15 months|All patients who receive at least one dose of treatment.|||Participants|||Count of Participants
1324920|NCT02194699|Secondary|Number of Patients With ≥1 Asthma Exacerbation up to Week 52|The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
1325021|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1324913|NCT02194699|Secondary|Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential|Assessments of ADA were performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for the presence of neutralising antibodies (nAb). ADA prevalence was defined as proportion of the study population having drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration. Note: 'positive' is denoted by 'pos' in some category titles.|Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)|The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
1324914|NCT02194699|Secondary|Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72|To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.|Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up)|All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients in the biomarker positive and negative PK populations and with data available at the timepoints of testing were included in the analyses.|||micrograms/millilitre||Geometric Coefficient of Variation|Geometric Mean
1324915|NCT02194699|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of ‘since the last scheduled visit’. Total number of assessments was calculated across all patients for the following healthcare encounter category:~• Spirometry."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Assessments|||Number
1324916|NCT02194699|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of ‘since the last scheduled visit’. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:~• Hospitalisations (hospitalisations, intensive care and/or general care)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Days|||Number
1324917|NCT02194699|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of ‘since the last scheduled visit’. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:~Ambulance transport,~Emergency room visits,~Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),~Home visits (home visit, physician and/or other healthcare professional),~Telephone calls (telephone calls to physician and/or nurse), and~Advanced pulmonary function test."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Encounters|||Number
1324918|NCT02194699|Secondary|WPAI+CIQ: Activity Impairment at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient’s ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient’s experience over the previous 7 days.~The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.~Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percent impairment||Standard Deviation|Mean
1324919|NCT02194699|Secondary|Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient’s ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient’s experience over the previous 7 days.~The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.~Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).~Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/(Q7+Q8)*100; Presenteeism = (Q9/10)*100).~Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percent productivity loss||Standard Deviation|Mean
1326127|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects|||percent change||Standard Deviation|Mean
1324921|NCT02194699|Secondary|Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])|The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percentage of nights with awakenings||Standard Deviation|Mean
1324922|NCT02194699|Secondary|Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52|Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||L/min||Standard Deviation|Mean
1324923|NCT02194699|Secondary|Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)|Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Puffs/day||Standard Deviation|Mean
1324924|NCT02194699|Secondary|Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1324925|NCT02194699|Secondary|AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52|"The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).~AAER = number of exacerbations*365.25 / (follow-up date – date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
1324926|NCT02194699|Secondary|Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score|The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score >1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1324927|NCT02194699|Secondary|Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score|The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1324965|NCT02193178|Primary|Anterior Ocular Health - Bulbar and Limbal Redness|Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1324928|NCT02194699|Secondary|Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)|Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1324929|NCT02194699|Secondary|Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)|Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percent change from baseline||Standard Deviation|Mean
1324930|NCT02194699|Primary|Annualised Asthma Exacerbation Rate (AAER) up to Week 52|"Asthma exacerbation was defined as a worsening of asthma that led to any of the following:~Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.~An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).~An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.~AAER = number of exacerbations*365.25 / (follow-up date – date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).~AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
1324931|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|12 hours||||colony forming units||Standard Error|Mean
1324932|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|Baseline||||colony forming units||Standard Deviation|Mean
1324933|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|12 hours||||colony forming units||Standard Error|Mean
1324934|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|Baseline||||colony forming units||Standard Deviation|Mean
1324935|NCT02194088|Secondary|Side Effects|The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)|baseline and 1 hour pain measurement|Participants were analyzed in terms of whether they endorsed or not the side effects (yes/no) Participants were not analyzed in terms of severity degree|||Participants|||Count of Participants
1324936|NCT02194088|Secondary|Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief|Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism|baseline and 1 hour pain measurement|Data were not collected||||||
1324937|NCT02194088|Primary|Pain Scores on Standardized Experimental Pain Testing|Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)|baseline and 1 hour pain measurement||||units on a scale||Standard Deviation|Mean
1324938|NCT02194062|Secondary|Lund-Kennedy Scoring for Nasal Endoscopy|The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.|6 months post-op||||units on a scale||95% Confidence Interval|Mean
1324939|NCT02194062|Primary|SNOT-22 Scores|SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.|6 months post-op.||||units on a scale||95% Confidence Interval|Mean
1324966|NCT02193178|Primary|Anterior Ocular Health - Palpebral Hyperemia and Roughness|Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1333291|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for rash/hives.|24 hours||||Participants|||Count of Participants
1324940|NCT02193828|Secondary|Composite Responder Analysis|A composite responder is a subject who had an improved assessment [values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)] on the investigator global assessment and had a satisfied assessment [values of 1 (very satisfied) or 2 (quite satisfied)] on the subject assessment.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.|||participants|||Number
1324941|NCT02193828|Secondary|Subject Satisfaction With Treatment|Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.|||units on a scale||Standard Deviation|Mean
1324942|NCT02193828|Secondary|Investigator Global Assessment of Improvement With Treatment|Investigators were asked to determine the degree of improvement in the subject’s treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.|||units on a scale||Standard Deviation|Mean
1324943|NCT02193828|Secondary|Change From Baseline in Nodular Pain of the Treated Nodule at Day 57|After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.|||units on a scale||Standard Deviation|Mean
1324944|NCT02193828|Secondary|Percent Change From Baseline in Hardness of the Treated Nodule at Day 57|A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.|||percentage of change||Standard Deviation|Mean
1324945|NCT02193828|Secondary|Change From Baseline in Consistency of the Treated Nodules at Day 57|Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.|||units on a scale||Standard Deviation|Mean
1324946|NCT02193828|Secondary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound|Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.|||percentage of change||Standard Deviation|Mean
1324947|NCT02193828|Primary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements|Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on Modified Intent-to-Treat (mITT) population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.|||percentage of change||Standard Deviation|Mean
1324948|NCT02193815|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg.|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.|||participants|||Number
1324967|NCT02193178|Primary|Lens Fit Acceptance|General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.|||units on a scale|eyes|Standard Deviation|Mean
1325022|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1324949|NCT02193815|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.|||participants|||Number
1324950|NCT02193815|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.|Baseline up to 28 days after last study drug administration (Day 21)|The safety population included all enrolled participants who received at least 1 dose of investigational product.|||participants|||Number
1324951|NCT02193815|Secondary|Global Clinical Assessment at Day 1, 8 and 12|"Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as 0 (unchanged)."|Day 1, Day 8, Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||participants|||Number
1324952|NCT02193815|Secondary|Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB|The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.|Day 1 (baseline) up to Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers*day||Standard Deviation|Mean
1324953|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8||Day 1 (Baseline), Day 8|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
1324954|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
1324955|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
1324956|NCT02193815|Primary|Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12|Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.|Day 1 (Baseline), Day 12|The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
1324957|NCT02193178|Primary|Investigator Acceptability|Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.|Baseline and 2 weeks||||percentage of subjects|||Number
1324958|NCT02193178|Primary|Overall Preference|Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks||||percentage of subjects|||Number
1324959|NCT02193178|Primary|Preference - Handling|Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|Missing data for handling preference for one participant.|||percentage of subjects|||Number
1324960|NCT02193178|Primary|Preference - Vision|Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks||||percentage of subjects|||Number
1324961|NCT02193178|Primary|Subjective Preference - Comfort|Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks||||percentage of subjects|||Number
1324962|NCT02193178|Primary|Visual Acuity|Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||LogMAR||Standard Deviation|Mean
1324963|NCT02193178|Primary|Anterior Ocular Health - Conjunctival Staining and Indentation|Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1324964|NCT02193178|Primary|Anterior Ocular Health - Corneal Staining|Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
1324968|NCT02193178|Primary|Lens Fit - Overall Stability|Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.|||units on a scale|eyes|Standard Deviation|Mean
1324969|NCT02193178|Primary|Lens Fit - Rotation|Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.|||percentage of eyes|eyes||Number
1324970|NCT02193178|Primary|Overall Satisfaction|Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
1324971|NCT02193178|Primary|Handling|Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
1324972|NCT02193178|Primary|Overall Vision|Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.|2 weeks prior to baseline, Baseline, 2 weeks post|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
1324973|NCT02193178|Primary|Overall Comfort|Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
1324974|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks||||units on a scale||Standard Deviation|Mean
1324975|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks||||units on a scale||Standard Deviation|Mean
1324976|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
1324977|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||units on a scale||Standard Deviation|Mean
1324978|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks||||units on a scale||Standard Deviation|Mean
1324979|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
1324980|NCT02193087|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set|Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.|Days 8, 15, 91, 97 and 104|"The Safety Laboratory Sub-Set included randomly chosen participants from each treatment group for whom samples for clinical safety lab tests were collected and who received at least one vaccination dose. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
1324981|NCT02193087|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Up to 6 Months after the last dose (9 months)|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1324982|NCT02193087|Secondary|Percentage of Participants With Any Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|Up to Day 28 after each vaccination|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1324983|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity|The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1324984|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity|The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.|||percentage of participants|||Number
1324985|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs)|Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1324986|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)|Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the Safety Set (SS) with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.|||percentage of participants|||Number
1324987|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Months 1 and 4|PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. “n” in each of the categories is the number of participants with data available at the given time-point.|||percentage of participants||95% Confidence Interval|Number
1324988|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1, and have no major protocol violations. Participants seropositive at Baseline are not included.|||percentage of participants||95% Confidence Interval|Number
1324989|NCT02193087|Secondary|Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B|Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.|Months 1 and 4|"PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. n in each of the categories is the number of participants with data available at the given time-point."|||titer||90% Confidence Interval|Least Squares Mean
1324990|NCT02193087|Primary|Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined|"Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.~A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis."|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included.|||titer||90% Confidence Interval|Least Squares Mean
1324991|NCT02193074|Secondary|Number of Participants With Clinically Significant Changes From Baseline in Urinalysis Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
1325020|NCT02192814|Other Pre-specified|The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5|No descriptive statistics have been calculated for this exploratory Outcome Measure.|From Day -1 to Day 5|||||||
1324992|NCT02193074|Secondary|Summary of Shifts in 12-lead Electrocardiogram (ECG) Results|Shift to ‘abnormal, not clinically significant’ includes ‘unknown’ or ‘normal’ to ‘abnormal, not clinically significant’. Shift to ‘abnormal, clinically significant’ includes ‘unknown’ or ‘normal’ to ‘abnormal, clinically significant’.|up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and whose baseline value was not abnormal and who had at least one post-baseline value.|||participants|||Number
1324993|NCT02193074|Secondary|Number of Participants Meeting Selected Vital Sign Criteria Post-Baseline||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and had an assessment.|||participants|||Number
1324994|NCT02193074|Secondary|Number of Participants With AEs Corresponding to Changes in Blood Chemistry Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
1324995|NCT02193074|Secondary|Number of Participants With AEs Corresponding to Changes in Hematology Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
1324996|NCT02193074|Secondary|Number of Participants Experiencing Adverse Events (AEs), Serious AEs (SAEs) and Discontinuations Due to AEs|AE: any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. SAE: any AE that in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening: that is, poses an immediate risk of death at the time of the event; requires in-patient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect in the offspring of the participant (whether male or female); is an important medical event in the opinion of the Investigator or Sponsor.|Screening through Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
1324997|NCT02193074|Secondary|Time to Death or Permanent Ventilation in the Subgroup of Participants Above the Study Median Disease Duration|Estimated proportion of participants who died or required permanent ventilation (EAC-adjudicated events) among participants above the study median disease duration (13.1 weeks), by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were above the study median disease duration.|||proportion of participants|||Number
1324998|NCT02193074|Secondary|Time to Death or Permanent Ventilation in the Subgroup of Participants Below the Study Median Disease Duration|Estimated proportion of participants who died or required permanent ventilation (EAC-adjudicated events) among participants below the study median disease duration (13.1 weeks), by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were below the study median disease duration.|||proportion of participants|||Number
1324999|NCT02193074|Secondary|Percentage of Compound Muscular Action Potential (CMAP) Responders|CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. A participant was defined as a CMAP responder if the CMAP amplitude at the peroneal nerve was increasing to or maintained at ≥ 1 mV (comparing to the baseline) based on assessment at the later of the Day 183, Day 302, or Day 394 study visits. Results are based on all available data.|assessed at the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)|||percentage of participants|||Number
1325000|NCT02193074|Secondary|Percentage of Participants Not Requiring Permanent Ventilation||Up to Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure.|||percentage of participants|||Number
1325001|NCT02193074|Secondary|Summary of Time to Death|Estimated proportion of participants who died by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died. Results are based on all available data.|||proportion of particiants|||Number
1325002|NCT02193074|Secondary|Percentage of Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) Responders|A participants was considered a CHOP-INTEND responder if the change from baseline in CHOP-INTEND total score is ≥ 4 points based on assessment at the later of the Day 183, Day 302, or Day 394 study visits. CHOP-INTEND tests includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Results are based on all available data.|assessed at Baseline and the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)|||percentage of participants|||Number
1325003|NCT02193074|Primary|Time to Death or Permanent Ventilation|Estimated proportion of participants who died or required permanent ventilation by a given study day, based on the Kaplan-Meier product-limit method. Time to death or permanent ventilation was defined as either tracheostomy or ≥ 16 hours ventilation/day continuously for > 21 days in the absence of an acute reversible event. This endpoint was adjudicated by a blinded, independent group of experienced clinicians, the Event Adjudication Committee (EAC), based on review of clinical study data and supporting information. Results are based on all available data.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died or required permanent ventilation.|||proportion of participants|||Number
1325004|NCT02193074|Primary|Percentage of Motor Milestones Responders|"The definition of a motor milestones responder was based on improvement in the motor milestones categories in Section 2 of the Hammersmith Infant Neurological Examination (HINE), with the exclusion of voluntary grasp, as follows:~(i) subject demonstrates ≥ 2-point increase in the motor milestones category of ability to kick or achievement of maximal score on that category (touching toes), or a 1-point increase in the motor milestones category of head control, rolling, sitting, crawling, standing, or walking, and (ii) among the motor milestone categories, with the exclusion of voluntary grasp, there are more categories where there is improvement as defined in (i) than worsening. (For the category of ability to kick, worsening is defined as ≥ 2-point decrease or decrease to the lowest possible score of no kicking. For the other categories, worsening is defined as ≥ 1-point decrease.) The lowest possible score for the HINE is 0 (zero), and the highest possible score for the HINE is 28."|assessed at the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)|||percentage of participants|||Number
1325005|NCT02192905|Secondary|Social Problem Solving Inventory|The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.|16-week follow-up||||Total score||Standard Deviation|Mean
1325006|NCT02192905|Secondary|% Weight Change|Measured in pounds with a digital scale|16 week follow-up||||percentage of pounds||Standard Deviation|Mean
1325007|NCT02192905|Secondary|% Weight Change|Measured in pounds with a digital scale|8-week follow-up||||percentage of pounds||Standard Deviation|Mean
1325008|NCT02192905|Secondary|Problem Solving Inventory|The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.|8-week follow-up||||Total score||Standard Deviation|Mean
1325009|NCT02192905|Primary|Feasibility (Retention Rates)|Total attendance at groups and total withdrawn from the study|8-weeks||||Participants|||Count of Participants
1325010|NCT02192905|Primary|Feasibility (Recruitment Rates)|Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)|Baseline|Of the total number of participants screened for this study (n=559), 7.69% (n=43) were enrolled into the intervention.|||Participants|||Count of Participants
1325011|NCT02192905|Primary|Feasibility (Total Habits Attempted)|Total amount of new habits attempted during the study|8-week follow-up||||mean habits attempted||Standard Deviation|Mean
1325012|NCT02192905|Primary|Feasibility (Total Uses)|Mean total uses of the problem solving function of the mobile application|8-week follow-up||||mean uses of the app||Standard Deviation|Mean
1325013|NCT02192879|Other Pre-specified|Serious Adverse Events Associated With Regional Catheter Placement|Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored|postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days|only patients who had a catheter|||serious adverse events|||Number
1325014|NCT02192879|Secondary|Highest VAS Pain Scores With Coughing|Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days||||units on a scale||Standard Deviation|Mean
1325015|NCT02192879|Secondary|Incidence of Major Postoperative Complication|Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise||||complications|||Number
1325016|NCT02192879|Secondary|Cumulative Postoperative Opioid Requirement|Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.|postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days||||mg||Standard Deviation|Mean
1325017|NCT02192879|Secondary|Gastrointestinal Recovery|Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.|postoperatively until return of bowel function, up to 7 days||||days||Standard Deviation|Mean
1325018|NCT02192879|Secondary|Hospital Length of Stay|Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise||||days||Standard Deviation|Mean
1325019|NCT02192879|Primary|Highest VAS Pain Score at Rest|Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days||||units on a scale||Standard Deviation|Mean
1325023|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1325024|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1325025|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1325026|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1325027|NCT02192814|Primary|The Total Number of Subject Withdrawal Due to Adverse Events During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||participants|||Number
1325028|NCT02192814|Primary|The Total Number of Subjects Experiencing at Least One Adverse Event During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||participants|||Number
1325029|NCT02192684|Primary|Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo|To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.|8 weeks||||AHI events/hour||Inter-Quartile Range|Median
1325030|NCT02192606|Secondary|Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy|The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.|Time of Procedure End||||millileters||Standard Deviation|Mean
1325031|NCT02192606|Primary|Vaginal Cuff Closure Times|The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.|Start of vaginal cuff closure to end of vaginal cuff closure||||minutes||Standard Deviation|Mean
1325032|NCT02192541|Other Pre-specified|Number of Participants Who Had a Dose Limiting Toxicity (DLT)|A DLT is defined as an adverse event that is related (possibly, probably, or definitely) to administration of study drugs during cycle one and is a Grade ≥ 3 non-hematological toxicity. Grade ≥3 non-hematological toxicity felt to be related to study medications are: Grade 3 diarrhea if it is refractory to treatment; Grade 3 nausea and vomiting if it is refractory to anti-emetic therapy and unable to be corrected; rise in creatinine to Grade 3, not corrected to Grade 1 or less within 48 hours with intravenous (IV) fluids; Any Grade 4 corrected QT interval (QTc) prolongation; Grade 4 neutropenia ≥5 days or febrile neutropenia,...).|Cycle one (28 days)||||Participants|||Count of Participants
1325033|NCT02192541|Secondary|Number of Cycles on Treatment|The number of 28-day treatment cycles (ganetespib on days 1, 8, and 15; ziv-aflibercept on days 1 and 15) administered to each evaluable patient. Number represents treatment cycles that were started; not all cycles were completed.|up to 5 months|The number of participants who were evaluable for response|||cycles||Full Range|Median
1325034|NCT02192541|Secondary|Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)|Radiologic response assessments by computed tomography (CT) scans were performed at baseline and every two cycles to evaluate tumor response based on the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Baseline and every 2 months up to 5 months||||Participants|||Count of Participants
1325035|NCT02192541|Secondary|Modulation of Epidermal Growth Factor Receptor (EGFR) Expression|To evaluate for tumor distribution of EGFR, patients were to undergo 89Zr-immuno-positron emission tomography (PET) imaging with 89Zr-labeled EGFR-targeting panitumumab antibody evaluate modulation of EGFR client protein prior to and after treatment with the combination of ganetespib and ziv-aflibercept. Panitumumab is a fully human monoclonal antibody that targets EGFR and competes with endogenous ligands to block stimulation of EGFR. 89z-immuno-PET imaging with panitumumab as a targeting ligand allows for quantification of EGFR within tumors.|Cycle 1 Day 16|Data were not collected from any participant for this Outcome Measure. As the trial was closed before the maximum tolerated dose (MTD) was established, patients were not enrolled to an expansion phase, and samples for pharmacodynamics analysis were not obtained.||||||
1325102|NCT02190721|Secondary|Participants With Severe Neutropenia|Count of participants who had an incidence of severe neutropenia, defined as any value of absolute neutrophil count (ANC) <0.5 * 10^9/L at any time.|ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|The Full Analysis Set (FAS) included all patients in the ITT population who received at least 1 dose of tbo-filgrastim and had at least 1 post baseline efficacy assessment.|||Participants|||Count of Participants
1325036|NCT02192541|Secondary|Modulation of Hypoxia-Inducible Factor 1 (HIF-1) Alpha|To determine whether the combination of ganetespib and ziv-aflibercept modulated intratumoral Hypoxia-inducible factor 1 (HIF-1)-alpha expression, tumor biopsies were to be analyzed for change in HIF-1-alpha expression by immunofluorescence assay (IFA). Paired pre-and post-combination treatment samples were to be compared for qualitative changes in levels of HIF-1- alpha expression. Cores were to be normalized against the percentage of tumor within the sample.|Cycle 2, Day 7|Data were not collected from any participant. Biopsies were to be collected from an expansion cohort treated at the maximum tolerated dose, after the conclusion of the dose escalation phase. Trial was closed before the MTD was established, patients were not enrolled to an expansion phase, and samples for pharmacodynamics analysis were not obtained.||||||
1325037|NCT02192541|Primary|Maximum Tolerated Dose (MTD) of the Combination of Ganetespib and Ziv-aflibercept|MTD is defined as the dose level at which no more than 1 of 6 patients experience a dose limiting toxicity (DLT) during the first cycle of the treatment, and the dose level below that at which at least 2 (of <6) patients have a DLT as a result of the drug. Determination of DLT is based on the first cycle of treatment.|Cycle one (28 days)|An MTD was not established because no MTD data were collected. The trial was terminated before the MTD was reached due to the decision of the drug supplier to suspend further clinical development of ganetespib.||||||
1325038|NCT02192541|Primary|Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs|Adverse Events were graded according to Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the Adverse Event. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event (AE). AEs were considered possibly attributable to both study drugs, except where otherwise noted. Star (*) symbol indicates that the AE is possibly related to Ziv-aflibercept and unlikely to be related to Ganetespib.|Date treatment consent signed to date off study, approximately 12 months and 44 days||||Participants|||Count of Participants
1325039|NCT02192541|Primary|Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 12 months and 44 days||||Participants|||Count of Participants
1325040|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants|Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation. Here, ‘N’ signifies those participants who were evaluable for this measure. Data for this outcome measure was planned to be analyzed in smokers and former smokers.|||years||Standard Error|Mean
1325041|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted|Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for each arm. Data for this outcome measure was planned to be analyzed in smokers and former smokers.|||years||Standard Error|Mean
1325042|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Smoking Status of Participants|Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation.|||participants|||Number
1325043|NCT02192164|Secondary|Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24|Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Week 12, 24|All treated participants with available post-baseline documentation.|||percent change||Standard Deviation|Mean
1325054|NCT02191579|Secondary|Change From Baseline in Headache Impact Test (HIT-6) Total Score|"The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a “best to worst” scoring.~A negative change from Baseline (a lower score) indicates improvement."|Baseline (Day 1) to the last 28-day period ending with Week 30|Participants from the ITT Set, all randomized participants, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325044|NCT02192164|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.|Week 12, 24|All treated participants with available post-baseline documentation.|||percentage of participants|||Number
1325045|NCT02192164|Secondary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Week 12|All treated participants with available post-baseline documentation.|||units on a scale||Standard Deviation|Mean
1325046|NCT02192164|Primary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90–100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline (Day 1), Week 24|All treated participants with available post-baseline documentation.|||units on a scale||Standard Deviation|Mean
1325047|NCT02191865|Secondary|Number (%) of Subjects With Drug-related Adverse Events (AEs)|Number (%) of subjects with drug-related Adverse events (AEs)|(AEs) during the 'on-treatment' period (from administration of trial medication until the end of the 28-day residual effect period); Up to 29 days|TS|||percentage of participants|||Number
1325048|NCT02191865|Secondary|AUC (0-tz) of Nintedanib|AUC (0-tz) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1325049|NCT02191865|Primary|Cmax of Nintedanib|Cmax (Maximum measured concentration of the Nintedanib in plasma)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325050|NCT02191865|Primary|AUC (0-inf) of Nintedanib|AUC (0-inf) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 extrapolated to infinity)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1325051|NCT02191605|Primary|Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery|Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.|self-reported use during 90 days prior to delivery of their baby||||Participants|||Count of Participants
1325052|NCT02191605|Primary|Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery|Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.|self-reported use during 7 days prior to delivery of their baby||||Participants|||Count of Participants
1325053|NCT02191579|Secondary|Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days|Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 70% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.|Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32|ITT Set included all randomized participants.|||percentage of participants|||Number
1325738|NCT02175212|Secondary|Cause-specific Survival|Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse|5 years||||participants|||Number
1325055|NCT02191579|Secondary|Change From Baseline in the Frequency of Headache Days Per 28-day Period|Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. A negative change from Baseline (less headache days) indicates improvement.|Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32|ITT Set included all randomized participants.|||days||Standard Deviation|Mean
1325056|NCT02191579|Primary|Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days|Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.|Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32|ITT Set included all randomized participants.|||percentage of participants|||Number
1325057|NCT02191267|Secondary|Beta-Amyloid (Aβ) Protein Uptake.|Mean and standard deviation for standardized uptake value ratios (SUVr) for posterior cingulate, superior parietal, lateral frontal, medial frontal, lateral temporal, and occipital brain regions. Each [F18]-Florbetapir (Beta-Amyloid) scan consisted of a 70-minute dynamic acquisition after bolus intravenous injection of 10 mCi of [18F]-Florbetapir. SUVr images were constructed from the sum of the 50-70 minute frames resulting in late SUVr distribution maps.|Day 2 - of 2 day study.||||SUVr||Standard Deviation|Mean
1325058|NCT02191267|Primary|Tau Protein Uptake..|Whole brain mean (and standard deviation) cortical value derived from standardized uptake value ratio (SUVr). Each [F18]-T807 tau scan consisted of a 60-minute dynamic acquisition after bolus intravenous injection of 10 mCi of [18F]-T807, followed by a second 20-minute dynamic imaging (list mode) acquisition from 80-100 minutes. SUVr images were constructed from the sum of the 80-100 minute frames resulting in late SUVr distribution maps.|Day 1 - of 2 day study.||||SUVr||Standard Deviation|Mean
1325059|NCT02191137|Secondary|Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)|Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient’s exercise capacity. The distance walked by the patient in 6 minutes was measured.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for 6MWD at week 24.|||Meters||Standard Deviation|Mean
1325060|NCT02191137|Secondary|Change From Baseline to Weeks 16 and 24 in the 6MWD|"Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient’s exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Week 16 to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 67 patients were evaluable for 6MWD at week 24.|||Meters||Standard Deviation|Mean
1325061|NCT02191137|Secondary|Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)|The Modified Borg Dyspnea Scale assessed the intensity of the patient’s dyspnea from 0 (best) to 10 (worst).|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for Modified Borg Dyspnea Scale at Week 24.|||Scores||Standard Deviation|Mean
1325062|NCT02191137|Secondary|Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale|"The Modified Borg Dyspnea Scale assessed the intensity of the patient’s dyspnea from 0 (best) to 10 (worst). In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Week 16 to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 58 patients were evaluable for Modified Borg Dyspnea Scale at week 24.|||Scores||Standard Deviation|Mean
1325063|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)|"Functional class was determined by the WHO classification:~I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.~III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for WHO Function Class at Week 24.|||Percentage of participants|||Number
1325064|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class|"Functional class was determined by the WHO classification:~I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.~III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.~In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for WHO Function Class at Week 16 or Last Before.|||Percentage of participants|||Number
1325065|NCT02191137|Secondary|Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)|SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient’s point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for PCS and MCS at Week 24.|||Scores||Standard Deviation|Mean
1325066|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score|"SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient’s point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 73 patients were evaluable for PCS and MCS at Week 4.|||Scores||Standard Deviation|Mean
1325067|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)|The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ percentage of productivity loss at week 24.|||Percentage||Standard Deviation|Mean
1325068|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)|The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ at Week 24.|||Scores||Standard Deviation|Mean
1325069|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss|"The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 37 patients were evaluable for WLQ percentage of productivity loss at week 4.|||Percentage||Standard Deviation|Mean
1325070|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores|"The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 52 patients were evaluable for WLQ at week 4.|||Scores||Standard Deviation|Mean
1325071|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)|For the physical and emotional dimension scores, the MCID was a 4-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.|||Percentage of Participants|||Number
1325072|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)|For the physical and emotional dimension scores, the MCID was a 4-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients were evaluable for LPH physical dimension score at week 24.|||Percentage of Participants|||Number
1325073|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)|For LPH total score, the MCID was an 11-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.|||Percentage of Participants|||Number
1325148|NCT02190604|Primary|Part 3: Number of Participants (Patients) With Reported Adverse Events Receiving QBW251|All adverse events and serious adverse events (in patients) reported.|Day 1 to Day 56|Safety analysis set: All randomized patients were included in the safety analysis|||Participants|||Number
1325074|NCT02191137|Secondary|Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24|"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH emotional dimension score at week 4.|||Percentage of Participants|||Number
1325075|NCT02191137|Secondary|Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24|"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH physical dimension score at week 4.|||Percentage of Participants|||Number
1325076|NCT02191137|Secondary|Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24|"For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at week 4.|||Percentage of participants|||Number
1325077|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)|The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.|||Scores||Standard Deviation|Mean
1325078|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score|"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH emotional dimension score at week 16 or before.|||Scores||Standard Deviation|Mean
1325079|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)|The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for LPH physical dimension score at Week 24.|||Scores||Standard Deviation|Mean
1325080|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score|"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Weeks 4, 16, and 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH physical dimension score at week 16 or before.|||Scores||Standard Deviation|Mean
1325081|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)|The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.|||Scores||Standard Deviation|Mean
1325082|NCT02191137|Secondary|Change From Baseline to Weeks 4 and 16 in the LPH Total Score|"The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4 and Week 16|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at Week 4.|||Scores||Standard Deviation|Mean
1325101|NCT02190721|Secondary|Duration of Severe Neutropenia|The duration of severe neutropenia was derived by counting the number of days with absolute neutrophil count (ANC) values <0.5 * 10^9/L.|ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325083|NCT02191137|Primary|Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score|The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No’ to 5 ’Very much’. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.|Baseline to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 66 patients were evaluable for LPH total score at Week 24.|||Scores||Standard Deviation|Mean
1325084|NCT02191046|Secondary|the Contamination in Nasal Irrigation Devices|compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism|at second week after treatment|||||||
1325085|NCT02191046|Primary|the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children|For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment|compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment|The S5- score is the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).|||units on a scale||Standard Deviation|Mean
1325086|NCT02191033|Secondary|Smoking Abstinence|biochemically confirmed point prevalence of self reported past 7-day abstinence|6- and 12- weeks||||Participants|||Count of Participants
1325087|NCT02191033|Primary|Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.|We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.|6- and 12- weeks||||Participants|||Count of Participants
1325088|NCT02191033|Primary|Study Enrollment- Number of Participants Who Join the Study|We will report the number of persons who join the study.|baseline||||Participants|||Count of Participants
1325089|NCT02190903|Primary|Number of Participants With Postoperative Delirium After Hip Fracture Surgery|Delirium will be assessed by the Confusion Assessment Method Instrument (CAM), a validated method of assessing delirium based on the presence of both (1) an acute onset of signs and symptoms with a fluctuating course AND (2) inattention; PLUS (3) disorganized thinking OR (4) an altered level of consciousness.|Up to 5 days post hip fracture surgery||||Participants|||Count of Participants
1325090|NCT02190721|Secondary|Participants With Febrile Neutropenia During the First Cycle of Chemotherapy|Febrile neutropenia was defined as an axillary or external ear temperature >38.3°C (100.94°F) or 2 consecutive readings >37.8°C (100.04°F) at least 2 hours apart and an ANC <0.5 * 10^9/L. The efficacy variable was evaluated for up to 21 days from the start of the first cycle of chemotherapy.|(relative to tbo-filgrastim therapy) Days -7 to Day 14|Full analysis set|||Participants|||Count of Participants
1325091|NCT02190721|Secondary|Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Chemotherapy||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325092|NCT02190721|Secondary|Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Chemotherapy||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325093|NCT02190721|Secondary|Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Tbo-filgrastim Administration||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325094|NCT02190721|Secondary|Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Tbo-filgrastim Administration||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325095|NCT02190721|Secondary|Time to ANC Recovery To ≥2.0 * 10^9/L From ANC Nadir||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325096|NCT02190721|Secondary|Time to ANC Recovery To ≥1.0 * 10^9/L From ANC Nadir||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325097|NCT02190721|Secondary|Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Chemotherapy||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325098|NCT02190721|Secondary|Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Tbo-filgrastim Administration||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
1325099|NCT02190721|Secondary|Absolute Neutrophil Count (ANC) Nadir|ANC nadir (measured in 10^9/L) is the lowest ANC recorded.|ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||*10^9/L||Standard Deviation|Mean
1325100|NCT02190721|Secondary|Area Under The Serum Drug Concentration By Time Curve Of Absolute Neutrophil Count (AUC ANC)||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||*10^9/L * days||Standard Deviation|Mean
1325201|NCT02188849|Other Pre-specified|Serum Creatinine|Serum creatinine levels|Twelve weeks||||mg/dl||Standard Deviation|Mean
1325103|NCT02190721|Secondary|Terminal Elimination Rate (Lambda-z)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||1/hr||Standard Deviation|Mean
1325104|NCT02190721|Secondary|Percentage of the AUC0–∞ That Is Due To the Extrapolation (%AUCext)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||percent of AUC0–∞||Standard Deviation|Mean
1325105|NCT02190721|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||liters||Standard Deviation|Mean
1325106|NCT02190721|Secondary|Apparent Clearance (CL/F)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose of Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||L/hour||Standard Deviation|Mean
1325107|NCT02190721|Secondary|Elimination Half-life (t1/2)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||hours||Standard Deviation|Mean
1325108|NCT02190721|Secondary|AUC From Time 0 to Infinity (AUC0-inf)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||hr*pg/mL||Standard Deviation|Mean
1325109|NCT02190721|Secondary|Area Under The Serum Concentration-Time Curve From Time 0 To 12 Hours Postdose (AUC0-12)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. In 4 participants, serum concentrations of tbo-filgrastim were not obtained through 12 hours and as a result, AUC0-12 could not be calculated.|||hr*pg/mL||Standard Deviation|Mean
1325110|NCT02190721|Secondary|Area Under The Serum Concentration-Time Curve From Time 0 To Time Of Last Quantifiable Concentration (AUClast)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set|||hr*pg/mL||Standard Deviation|Mean
1325111|NCT02190721|Secondary|Time to Maximum Observed Serum Concentration (Tmax) of Tbo-Filgrastim||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set|||Hours||Full Range|Median
1325112|NCT02190721|Secondary|Maximum Observed Serum Concentration (Cmax) of Tbo-Filgrastim||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|Pharmacokinetic (PK) analysis set|||pg/mL||Standard Deviation|Mean
1325113|NCT02190721|Secondary|Participants With Positive Immunogenicity Findings Tested at Four Study Timepoints|"Blood was drawn for the assessment of anti-drug antibody (ADA) at screening, at the end-of-study visit, and at 30 and 90 days after the last administration of tbo-filgrastim in chemotherapy (CTX) cycle 1.~The main endpoint from the assessment was the presence of antibodies in the sample, reported as positive or negative. Participants with positive results are summarized."|Baseline (Day -21), Day 21 (end of study visit), Day 51 (30 Day follow-up) and Day 111 (90 Day follow-up)|Safety analysis set|||Participants|||Count of Participants
1325114|NCT02190721|Primary|Participants Who Were Alive at the 90 Day Follow-Up|Summary of participant survival at 90 day follow-up.|90 days post end of study visit (111 days from start of tbo-filgrastim administration)|Safety analysis set|||Participants|||Count of Participants
1325115|NCT02190721|Primary|Participants With Negative Shifts From Baseline to End of Study in Spleen Sonography Findings|"The investigator assessed spleen sonography findings as normal, abnormal not clinically significant, or abnormal clinically significant.~Data representing counts of participants with a negative shift from baseline in spleen sonography findings (including shifts from normal to abnormal, not clinically significant) are presented."|Baseline: Day -21, Day 21 (end of study visit)|Safety analysis set|||Participants|||Count of Participants
1325116|NCT02190721|Primary|Participants With Injection Site Reactions to Tbo-Filgrastim Administration|Using Local Tolerability Assessment Scale ranging from Pain severity 0 (Absent) to 3 (Spontaneously painful)|Day 1 (start of tbo-filgrastim administration) up to Day 14|Safety analysis set|||Participants|||Count of Participants
1325117|NCT02190721|Primary|Participants With Negative Shifts From Baseline to End of Study in Physical Exam Findings|"Physical examination was performed at screening and at the end-of-study visit. The following body systems were marked as normal or abnormal and if abnormal, whether clinically significant: Head, ears, eyes, nose and throat (HEENT), chest and lungs, heart, abdomen, skin, lymph nodes and neurological.~Any physical examination finding that is judged by the investigator as a clinically significant change (worsening) compared with a baseline value were considered as an adverse event.~Counts of participants with a negative shift from baseline in any of the body systems (including shifts from normal to abnormal, not clinically significant) are presented."|Baseline: Day -21, Day 21 (end of study visit)|Safety analysis set|||Participants|||Count of Participants
1325118|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Electrocardiogram Results|"Triplicate 12-lead ECGs were conducted at screening, predose, 4 and 6 hours postdose on day 1 of tbo-filgrastim administration, and at the end-of-study visit. The ECGs were interpreted by both the investigator and a qualified physician at the central diagnostic center as normal, abnormal not clinically significant, or abnormal clinically significant. The following parameters were measured/derived for each ECG assessment: heart rate, PR interval, RR interval, QT interval, corrected QT interval according to Fridericia’s formula (QTcF), corrected QT interval according to Bazett’s formula (QTcB), QRS duration, and QRS axis.~The count of participants with potentially clinically significant ECG findings is reported."|Day 1 (start of tbo-filgrastim administration) pre-dose, 4 hours post dose and 6 hours post dose; Day 21 (end of study visit)|Safety analysis set|||Participants|||Count of Participants
1325119|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs|"Vital sign tests included Pulse Rate (bpm), Systolic BP (mmHg), Diastolic BP (mmHg), Respiratory Rate (bpm), and Temperature (°C).~Only tests with potentially clinically significant abnormal results are reported."|Day 1 (start of tbo-filgrastim administration) up to Day 21|Safety analysis set|||Participants|||Count of Participants
1325120|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Hematology Results|"Hematology tests included Basophils ABS (x 10^9/L), Basophils (%), Eosinophils ABS (x 10^9/L), Eosinophils (%), Hematocrit (%), Hemoglobin (g/L), Lymphocytes Absolute Count (ABS) (x 10^9/L), Lymphocytes (%), Monocytes ABS (x 10^9/L), Monocytes (%), Neutrophils ABS (x 10^9/L), Neutrophils (%), Platelets (x 10^9/L), Red Blood Cell (RBC) (x 10^12/L), White Blood Cell (WBC) (x 10^9/L).~Only tests with potentially clinically significant abnormal results are reported.~ULN = upper limit of normal"|Day 1 (start of tbo-filgrastim administration) up to Day 21|Safety analysis set|||Participants|||Count of Participants
1325121|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results|"Serum chemistry tests included alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, indirect bilirubin, total bilirubin, calcium, creatinine, gammaglutamyl transpeptidase (GGT), glucose, potassium, lactate dehydrogenase (LDH), phosphate, sodium and uric acid.~Only tests with potentially clinically significant abnormal results are reported.~ULN = upper limit of normal"|Day 1 (start of tbo-filgrastim administration) up to Day 21|Safety analysis set|||Participants|||Count of Participants
1325122|NCT02190721|Primary|Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. A treatment-emergent AE (TEAE) is an AE occurring during the timeframe. A non-TEAE is any AE not considered a TEAE.~Severity was rated by the investigator using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale where 3=severe but not life-threatening, 4=life-threatening and 5=death. Relation of AE to treatment was determined by the investigator (related=reasonable possibility). Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|Non-TEAE: signing of informed consent to Day -1 (last day of CTX in week 1). And > 30 days after last dose of tbo-filgrastim (Day 46+). TEAE timeframe: Day 1 (start of tbo-filgrastim) to <= 30 days after the last dose (up to Day 45)|Safety analysis set. The safety analysis set included all enrolled patients who received at least 1 dose of tbofilgrastim.|||Participants|||Count of Participants
1325123|NCT02190604|Secondary|Part 2: CLr in Healthy Volunteers|Pharmacokinetics of QBW251 in urine: renal clearance following drug administration. In this analysis CLr will be reported using urine samples taken on Day 1 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1; Day 14 was calculated as urine was only collected up to 12 hours on Day 1 thus CLr cannot be calculated.|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
1325124|NCT02190604|Secondary|Part 2: Ae0-t in Healthy Volunteers|Pharmacokinetics of QBW251 in urine: amount of drug excreted in urine from time zero until last measurable concentration. In this analysis Ae0-t will be reported using urine samples taken on Day 1 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
1325125|NCT02190604|Secondary|Part 3: Time to Maximum Concentration (Tmax)|Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 in patients|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
1325126|NCT02190604|Secondary|Part 3: Tlast in CF Patients|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable day 1 and day 14|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
1325127|NCT02190604|Secondary|Part 3: Maximum Concentration (Cmax) in CF Patients|Observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Day 1and day 14 from patients|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ng/mL||Standard Deviation|Mean
1325128|NCT02190604|Secondary|Part 3: Plasma Concentration at the Last Quantifiable Time Point (Clast) of QBW251 in CF Patients|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day2|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ng/mL||Standard Deviation|Mean
1325129|NCT02190604|Secondary|Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of QBW251 in CF Patients|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ng × hr /mL||Standard Deviation|Mean
1325130|NCT02190604|Secondary|Part 2: T1/2 in Healthy Volunteers|terminal elimination half-life (T1/2). In this analysis T1/2 will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
1325131|NCT02190604|Secondary|Part 2: Racc in Healthy Volunteers|Accumulation ratio (Racc). In this analysis Racc will be reported using blood samples taken on Days 1 - 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 - 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||Ratio||Standard Deviation|Mean
1325132|NCT02190604|Secondary|Part 2: Vz/F in Healthy Volunteers|Apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||Liters||Standard Deviation|Mean
1325133|NCT02190604|Secondary|Part 2: CL/F in Healthy Volunteers|apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
1325134|NCT02190604|Secondary|Part 2: Cav in Healthy Volunteers|The average drug concentration in plasma during multiple dosing. In this analysis Cav will be reported using blood samples taken on Days 1 and 14 are from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ug/L||Standard Deviation|Mean
1325135|NCT02190604|Secondary|Part 2: AUC0-t|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration. In this analysis AUC0-t will be reported using blood samples taken on Day 14 are from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)||||hr*ng/mL||Standard Deviation|Mean
1325136|NCT02190604|Secondary|Part 2: Time to Maximum Concentration (Tmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
1325137|NCT02190604|Secondary|Part 2: Maximum Concentration (Cmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: observed maximum plasma concentration following QBW251 at steady state. In this analysis Cmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ug/L||Standard Deviation|Mean
1325147|NCT02190604|Secondary|Part 3:Change in Forced Expiratory Volume in 1 Second (FEV1) at Day 15|Forced Expiratory Volume in 1 second (FEV1) will be measured via spirometer according to international standards. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation|Baseline and Day 15|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis|||Liters||Standard Error|Least Squares Mean
1325202|NCT02188849|Secondary|Twelve Minutes Walk|Measurement of the distance that a participant can walk during 12 minutes|Twelve weeks||||meters||Standard Deviation|Mean
1325138|NCT02190604|Secondary|Part 2: AUCtau in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: the area under the plasma concentration-time curve from time zero to end of the dosing interval tau. In this analysis AUCtau will be reported. Samples taken on Days 1 and 14 from healthy volunteers|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr*ng/mL||Standard Deviation|Mean
1325139|NCT02190604|Secondary|Part 1: Vz/F in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||Liters||Standard Deviation|Mean
1325140|NCT02190604|Secondary|Part 1: CL/F in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the CL/F goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
1325141|NCT02190604|Secondary|Part 1: AUCinf in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration time curve from time zero to infinity. In this analysis AUCinf will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUCinf goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr*ng/mL||Standard Deviation|Mean
1325142|NCT02190604|Secondary|Part 1: T1/2 in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: terminal elimination half-life. In this analysis T1/2 will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the T1/2 goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
1325143|NCT02190604|Secondary|Part 1: Time to Maximum Concentration (Tmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In this part of the study a single dose was administered and samples were collected up to 5 days. As a result the Tmax is one value as the concentration-time curve goes to Day 5 (for some lower does QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
1325144|NCT02190604|Secondary|Part 1: Maximum Concentration (Cmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Days 1- 5 are from healthy volunteers|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ug/L||Standard Deviation|Mean
1325145|NCT02190604|Secondary|Part 1: AUC0-t in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUC0-t). In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUC0-t goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 2-5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
1325146|NCT02190604|Secondary|Part 3: Change in Cystic Fibrosis Questionnaire-Revised Reported Outcomes|Change in Cystic Fibrosis Questionnaire data will be obtained from patient reported outcomes (CFQ-R PRO). Respiratory Domain, cores range from 0 to 100, with higher scores indicating better health, a change of 4 is considered clinically relevant|Baseline and Day 14|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis|||Units on a scale||Standard Error|Least Squares Mean
1325203|NCT02188849|Secondary|Quadriceps Isometric Strength|Measurement of quadriceps isometric force using a quadriceps table|Twelve weeks||||Newtons||Standard Deviation|Mean
1325149|NCT02190604|Primary|Part 3: Change in Lung Clearance Index (LCI) From Baseline to Day 15|Change in Lung Clearance Index (LCI) will be conducted according to international standards in cystic fibrosis patients. Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test, A reduction in mean change from baseline for LCI2.5 indicates improvement.|Baseline and Day 15|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis|||Ratio||Standard Deviation|Mean
1325150|NCT02190604|Primary|Part 1 and 2:Number of Participants (Healthy Volunteers) With Reported Adverse Events Receiving QBW251|All adverse events (in healthy volunteers) reported.|Day 1 to Day 36|All treated subjects were included in the data analysis. Subjects were analyzed according to the study treatment(s) received.|||Participants|||Number
1325151|NCT02190591|Other Pre-specified|Third and Fourth Degree Lacerations|Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery|within the last 15-30 minutes of birth|participants with vaginal delivery only|||Participants|||Count of Participants
1325152|NCT02190591|Secondary|Dilation to Second Stage Labor|Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation|thirty minutes after epidural given to birth of baby|Included participants with vaginal delivery only|||minutes||Standard Deviation|Mean
1325153|NCT02190591|Primary|Delivery Rate|Rate of patients who deliver by cesarean section|.5-72 hours||||participants|||Number
1325154|NCT02190435|Secondary|Radiation Exposure|Intraoperative fluoroscopy exposure time for lag screw placement (seconds)|Intraoperative||||seconds||Standard Deviation|Mean
1325155|NCT02190435|Primary|Tip-to-apex Distance|Distance between lag screw tip and head surface as measured on the ADAPT system|Intraoperative||||mm||Standard Deviation|Mean
1325156|NCT02189954|Secondary|Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour|The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour|Postoperative 24.hour|Chi Square Test for categorical variables, for constant variables t test when suitable for normal distribution and when unsuitable for normal distrubition Mann Whitney U have been used for analysis. p < 0.05 was considered significant.|||units on a scale||Full Range|Median
1325157|NCT02189954|Primary|Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour|The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour|Postoperative 1.hour||||units on a scale||Full Range|Median
1325158|NCT02189941|Secondary|Safety and Tolerability of Deferiprone Sustained Release Tablets|The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests|From time of dose until 24 hours post dose|All subjects who received at least one dose of study medication and had at least one safety assessment|||participants|||Number
1325159|NCT02189941|Primary|Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide|Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||h||Standard Deviation|Mean
1325160|NCT02189941|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||h||Standard Deviation|Mean
1325161|NCT02189941|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||mcg/mL||Standard Deviation|Mean
1325162|NCT02189941|Primary|AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||mcg*h/mL||Standard Deviation|Mean
1325163|NCT02189941|Primary|AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||mcg*h/mL||Standard Deviation|Mean
1325164|NCT02189915|Secondary|Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy|Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless.|8 weeks||||Phosphocreatine levels (unitless)||Standard Deviation|Mean
1325165|NCT02189915|Primary|Depression Rating Scores|Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.|8-week||||units on a scale||Standard Deviation|Mean
1325204|NCT02188849|Primary|Rectus Femoris Cross Sectional Height|Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound|Twelve weeks||||cm||Standard Deviation|Mean
1325205|NCT02188784|Secondary|Change From Baseline in Ventilatory Efficiency Defined by Ve/VCO2|Change from baseline in Ventilatory Efficiency defined by Ve/VCO2 (carbon dioxide output) as measured by CPET|Measured at BL week 16|All randomized patients with available change data|||VE/VCO2 Slope||Standard Deviation|Mean
1325166|NCT02189863|Secondary|Standard Deviation of Lateral Positioning|The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).|||meters||Standard Deviation|Mean
1325167|NCT02189863|Primary|Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)|Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).|||seconds||Standard Deviation|Mean
1325168|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein(a) Production Rate (PR)|The production rate of lipoprotein(a) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline and Day 50|Efficacy Analysis Set with available data|||percent change||Standard Error|Least Squares Mean
1325169|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR)|The fractional catabolic rate (the percentage of lipoprotein(a) (Lp[a]) which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.|Efficacy Analysis Set with available data|||percent change||Standard Error|Least Squares Mean
1325170|NCT02189837|Secondary|Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)|The production rate of apolipoprotein B-100 in LDL was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate the production rate.|Baseline and Day 50|Efficacy Analysis Set|||percent change||Standard Error|Least Squares Mean
1325171|NCT02189837|Secondary|Percent Change From Baseline in LDL-C at Day 50|LDL-C was measured using ultrcentrifugation.|Baseline and Day 50|Efficacy Analysis Set with available data at both time points|||percent change||Standard Error|Least Squares Mean
1325172|NCT02189837|Primary|Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR)|The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation, and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.|Efficacy Analysis Set including all randomized and dosed participants who completed baseline and Day 50 measurements.|||percent change||Standard Error|Least Squares Mean
1325173|NCT02189759|Secondary|Duration of Kangaroo Mother Care|Skin to skin contact between baby and mother|Duration of hospitalization-an average of 2 weeks|"Infants in Standard Kanagroo Mother Care to one hour after birth and Standard Kangaroo Mother care to discharge groups received kangaroo mother care only during breastfeeding"|||Hours||Standard Error|Mean
1325174|NCT02189759|Secondary|Number Infants Admitted to the Neonatal Intensive Care Unit|Any admission to the neonatal intensive care unit for higher level care|Duration of hospitalization-an average of 2 weeks||||Participants|||Count of Participants
1325175|NCT02189759|Primary|Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge|Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth|At discharge or 24 hours after birth (whichever is first)||||Participants|||Count of Participants
1325176|NCT02189759|Primary|Number of Infants With Axillary Temperature <36.0 Degrees Celsius|Temperature taken per axilla using digital thermometer|Time of birth to 1 hour||||Participants|||Count of Participants
1325177|NCT02189668|Secondary|Number of Participants With Complicated Appendicitis|Number of Participants with complicated appendicitis|1 year||||Participants|||Count of Participants
1325178|NCT02189668|Primary|Number of Participants That Did Not Have an Appendectomy|Number of Participants that did not have an Appendectomy|1 year||||Participants|||Count of Participants
1325179|NCT02189382|Secondary|Change From Baseline in Tactile Threshold|"Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a yes response was repeated. If a second yes was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive yes responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure."|30 days||||Grams (g)||Standard Deviation|Mean
1325206|NCT02188784|Secondary|Change From Baseline in O2 Uptake Kinetics as Assessed by Mean Response Time From CPET|To determine the impact of oral Fe repletion on O2 Uptake Kinetics as measured by CPET|Measured at BL week 16|All randomized patients with available change data|||seconds||Standard Deviation|Mean
1325180|NCT02189382|Primary|Change From Baseline Air Challenge|The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.|30 days||||units on a scale||Standard Deviation|Mean
1325181|NCT02189317|Secondary|Difference in Time to First Opioid Use|The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."|||hours||Standard Deviation|Mean
1325182|NCT02189317|Secondary|Change in Home Opioid Use|The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."|||miligrams||Standard Deviation|Mean
1325183|NCT02189317|Primary|Change in Numerical Rating Scale (NRS) Pain Score|The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to “no pain” and ten is equal to “worst possible” pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."|||units on a scale||Standard Deviation|Mean
1325184|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1325185|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
1325186|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DHA||This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.|PK Population|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1325187|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DHA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
1325188|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1325189|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
1325190|NCT02189252|Primary|Baseline-adjusted Cmax for Plasma Total EPA + Total DHA|Cmax: Maximum measured plasma concentration over the time span specified|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population|||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
1325191|NCT02189252|Primary|Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA|AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population|||hr*nmol/mL||Geometric Coefficient of Variation|Geometric Mean
1325192|NCT02189161|Secondary|Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition|Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)|0-2 weeks Prior RFA and after 9-12 months post RFA||||units on a scale||Full Range|Median
1325193|NCT02189161|Secondary|Subject Tolerability: Post -Ablation Anal Pain|Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)|within 4 weeks post RFA||||units on a scale||Full Range|Median
1325194|NCT02189161|Primary|Related Adverse Events|Adverse event : Device relationship - Definite, Probable, Possible|Within 12 months post RFA||||number of participants|||Number
1325195|NCT02189122|Primary|Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection|Data are given for 162.5 mg study day|||ng/mg creatinine||Inter-Quartile Range|Median
1325196|NCT02189122|Primary|Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
1325197|NCT02189122|Primary|Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
1325198|NCT02189122|Primary|Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
1325199|NCT02189122|Primary|Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
1325200|NCT02189122|Primary|Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
1325207|NCT02188784|Secondary|Change in Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical Summary Score|"To determine the impact of oral Fe repletion on Health Status: KCCQ.~KCCQ is a 23-item, self administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQs questions are used to calculate scores in ten domains. Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall summary: a combined measure of all the above.~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Measured at Baseline, Week 8 and Week 16|All randomized patients with available change data|||units on a scale||Standard Deviation|Mean
1325208|NCT02188784|Secondary|Change in Plasma NT-pro BNP|To determine the impact of oral Fe repletion on Plasma N-terminal pro-B-type natriuretic peptide (NT-pro BNP)|Measured at Baseline and Week 16|All randomized patients with available change data|||pg/ml||Standard Deviation|Mean
1325209|NCT02188784|Secondary|Change From Baseline in Sub-maximal Exercise Capacity as Assessed by the 6 Minute Walk Test (6MWT)|To determine the impact of oral Fe repletion on Submaximal exercise capacity as measured by 6MWT|Measured at BL, week 8 and week 16|All randomized patients with available change data|||meters||Standard Deviation|Mean
1325210|NCT02188784|Primary|Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption)|To determine if oral Fe (Iron) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks.|Baseline (BL) and Week 16|All randomized patients with available change data|||mL/min||Standard Deviation|Mean
1325211|NCT02188589|Secondary|Secondary Efficacy Endpoint|"Nasal patency assessed by validated NOSE (Nasal Obstruction Symptom Evaluation) Questionnaire. The NOSE score uses a 0 - 20 point scale to capture severity of breathing symptoms, with higher scores indicating more severe symptoms than lower scores. NOSE scores are converted to a 100-point scale by multiplying the total score by 5."|6 months||||scores on a scale||Standard Deviation|Mean
1325212|NCT02188589|Primary|Implant Related Adverse Events|Implant related adverse events|6 months||||implant related adverse events|Number of Implants||Number
1325213|NCT02187887|Primary|Alcohol-related Consequences|"Brief Young Adult Alcohol Consequences Questionnaire. This is a 21 item measure of alcohol-related consequences experienced by young adults. Participants indicate whether or not they have experienced each of the consequences in the past month (1 = yes, 0 = no). Scores range from 0 to 21 with higher scores indicated a greater number of consequences experienced.~Citation: Kahler, C. W., Strong, D. R., & Read, J. P. (2005). Toward efficient and comprehensive measurement of the alcohol problems continuum in college students: The Brief Young Adult Alcohol Consequences Questionnaire. Alcoholism: Clinical and Experimental Research, 29(7), 1180-1189."|Past month (30 days)||||consequences at follow-up month||Standard Deviation|Mean
1325214|NCT02187887|Primary|Alcohol Use|Total drinks per week in the past 30 days|Past month (30 days)||||drinks per week at follow-up month||Standard Deviation|Mean
1325215|NCT02187861|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax|Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.|||hours*ng/mL||Standard Deviation|Mean
1325216|NCT02187861|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax|Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population|||hours*ng/mL||Standard Deviation|Mean
1325217|NCT02187861|Secondary|Maximum Plasma Concentration (Cmax) of Venetoclax||Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1325218|NCT02187861|Secondary|Time to Maximum Plasma Concentration (Tmax) of Venetoclax||Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax.|||hours||Full Range|Median
1325219|NCT02187861|Secondary|Apparent Volume of Distribution (Vd) of Venetoclax|Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd.||||||
1325220|NCT02187861|Secondary|Apparent Clearance (CL) of Venetoclax|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL.||||||
1325739|NCT02175212|Secondary|Overall Survival: Estimated Percentage of Participants Alive at 5 Years|Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.|5 years||||percentage of patients||95% Confidence Interval|Number
1325221|NCT02187861|Secondary|Overall Survival (OS)|OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.|Baseline until death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population|||months||95% Confidence Interval|Median
1325222|NCT02187861|Secondary|Percentage of Participants Who Died Due to Any Cause||Baseline until death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population|||percentage of participants|||Number
1325223|NCT02187861|Secondary|Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan|EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.|Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population|||months||95% Confidence Interval|Median
1325224|NCT02187861|Secondary|Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy|PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.|Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population|||percentage of participants|||Number
1325225|NCT02187861|Secondary|Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan|PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population|||months||95% Confidence Interval|Median
1325226|NCT02187861|Secondary|Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death|PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population|||percentage of participants|||Number
1325227|NCT02187861|Secondary|Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan|DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.|From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1325228|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan up to Data Cut-off (06 April 2017)|OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years [cut-off date 06 April 2017])|ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.|||percentage of participants|||Number
1325229|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan|OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325821|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|3-9 years||2024-06-30|06/2024||||
1325230|NCT02187861|Secondary|Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan|OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325231|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan|OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325232|NCT02187861|Secondary|Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan|OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325233|NCT02187861|Secondary|Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan|CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325234|NCT02187861|Secondary|Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan|CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325235|NCT02187861|Secondary|Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325236|NCT02187861|Secondary|Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325237|NCT02187861|Secondary|Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325270|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6|DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
1333292|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for insomnia.|24 hours||||Participants|||Count of Participants
1325238|NCT02187861|Primary|Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)|CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
1325239|NCT02187809|Secondary|Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.||||||
1325240|NCT02187809|Secondary|Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.||||||
1325241|NCT02187809|Secondary|Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures||Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.||||||
1325242|NCT02187809|Primary|Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.||||||
1325243|NCT02187809|Primary|Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years||Baseline and from Day 0 to Day 360|At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.||||||
1325244|NCT02187809|Primary|Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study|||participants|||Number
1325245|NCT02187809|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.|||participants|||Number
1325246|NCT02187744|Secondary|Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.|The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.|Cycles 1 through 6|All participants who received at least 1 dose of study drug.|||Number of participants|||Number
1325247|NCT02187744|Secondary|Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.|The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.|Cycles 1 through 6|All participants who received at least 1 dose of study drug.|||Number of participants|||Number
1325248|NCT02187744|Secondary|Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.|ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.|Cycle 6/End of treatment|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1325249|NCT02187744|Secondary|Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.|Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.|Cycle 6/End of treatment|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1325250|NCT02187744|Secondary|Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.|Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.|Cycles 1 through 6|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||μg/mL||Standard Deviation|Mean
1325251|NCT02187744|Primary|Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.|The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.|Cycle 5|All participants who were HER2+ and randomized into the study; and who had received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1325252|NCT02187055|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant’s response (with the exception of 2 negatively stated), the greater the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Month 6|FAS|||Units on a scale||Standard Error|Least Squares Mean
1325253|NCT02187055|Secondary|Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6|"The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state."|Month 6|FAS|||Units on a scale||Standard Error|Least Squares Mean
1325254|NCT02187055|Secondary|Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6|The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.|Month 6|FAS|||Percentage of impairment||Standard Error|Least Squares Mean
1325255|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325256|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325257|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325258|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325259|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent’s view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325260|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325271|NCT02187055|Secondary|Percentage of Participants Achieving CDAI ≤10 at Month 6|CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
1325902|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|5 years||2022-12-31|12/2022||||
1325261|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325262|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325263|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6|The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325264|NCT02187055|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6|The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325265|NCT02187055|Secondary|Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.|Month 6|FAS|||Percentage of participants|||Number
1325266|NCT02187055|Secondary|Change From Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI) at Month 6|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Month 6|FAS|||Units on a scale||Standard Error|Least Squares Mean
1325267|NCT02187055|Secondary|Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6|ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.|Month 6|FAS|||Percentage of participants|||Number
1325268|NCT02187055|Secondary|Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6|ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.|Month 6|FAS|||Percentage of participants|||Number
1325269|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6|DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
1325272|NCT02187055|Secondary|Percentage of Participants Achieving SDAI ≤11 at Month 6|SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, >3.4 to 11 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
1325273|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6|DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission.|Month 6|FAS|||Percentage of participants|||Number
1325274|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6|DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission.|Month 6|FAS|||Percentage of participants|||Number
1325275|NCT02187055|Secondary|Percentage of Participants Achieving CDAI ≤2.8 at Month 6|CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.|Month 6|FAS|||Percentage of participants|||Number
1325276|NCT02187055|Secondary|Percentage of Participants Achieving SDAI ≤3.3 at Month 6|SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.|Month 6|FAS|||Percentage of participants|||Number
1325277|NCT02187055|Secondary|Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6|To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).|Month 6|FAS|||Percentage of participants|||Number
1325278|NCT02187055|Secondary|Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6|DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325279|NCT02187055|Secondary|Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6|DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325280|NCT02187055|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6|CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325281|NCT02187055|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6|SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
1325282|NCT02187055|Primary|Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6|ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.|Month 6|Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab).|||Percentage of participants|||Number
1325283|NCT02187029|Secondary|Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg||Standard Deviation|Mean
1325284|NCT02187029|Secondary|Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary xanthine cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg||Standard Deviation|Mean
1325285|NCT02187029|Secondary|Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary uric acid cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg||Standard Deviation|Mean
1325286|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up||Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mcg/mL||Standard Deviation|Mean
1325287|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up|Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.|Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1325288|NCT02187029|Secondary|Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14|PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).|Day 1, Day 7, and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||ng/mL||Standard Deviation|Mean
1325289|NCT02187029|Secondary|Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14|Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).|0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14|All participants randomized and treated who have at least 1 measureable concentration; n=number of participants analyzed in each respective arm.|||ng/mL||Standard Deviation|Mean
1325290|NCT02187029|Secondary|Duration of Gout Flare Attacks|Duration of gout flare attacks with participants who developed gout flare attacks.|Baseline up to Day 42|Participants who developed gout flare attacks (Duration was not assessed as no participant developed gout flare attacks).||||||
1325291|NCT02187029|Secondary|Incidence and Severity of Gout Flare Attacks||Baseline up to Day 42|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.|||participants|||Number
1325292|NCT02187029|Secondary|Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14|Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation.|24 hours post dose on Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.|||participants|||Number
1325293|NCT02187029|Secondary|Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up||Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg/dL||Standard Deviation|Mean
1325294|NCT02187029|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to < 480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec from baseline.|Baseline up to Day 16|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
1325295|NCT02187029|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
1325296|NCT02187029|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
1325325|NCT02186223|Secondary|Incidence of Acute Proximal Deep Vein Thrombosis||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
1325297|NCT02187029|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events.|Baseline up to 28 days after last study drug administration (Day 42)|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
1325298|NCT02187029|Primary|Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14||Day 14 Hour 24|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to “Cohort 2: PF-06743649 5 mg” termination after 2 days of dosing.|||percent (%)||Standard Deviation|Mean
1325299|NCT02187029|Primary|Baseline of Serum Uric Acid|An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.|Baseline (pre-dose Day 1)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.|||milligram per deciliter(mg/dL)||Standard Deviation|Mean
1325300|NCT02187016|Secondary|Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|28 days||||units on a scale||Standard Error|Least Squares Mean
1325301|NCT02187016|Secondary|Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|14 days||||units on a scale||Standard Error|Least Squares Mean
1325302|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|28 days||||units on a scale||Standard Error|Least Squares Mean
1325303|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|14 days||||units on a scale||Standard Error|Least Squares Mean
1325304|NCT02187016|Secondary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28|MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).|28 days||||units on a scale||Standard Error|Least Squares Mean
1325305|NCT02187016|Primary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14|MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).|14 days||||units on a scale||Standard Error|Least Squares Mean
1325306|NCT02186938|Secondary|Number of Participants Requiring a Ventilator|The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator|The number of participants requiring a ventilator after surgery.||||participants|||Number
1325307|NCT02186938|Primary|ICU Stay|The primary outcome is length of ICU stay.|Participants were assessed for their ICU duration in number of hours.||||hours||Full Range|Mean
1325308|NCT02186873|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on Scale||Standard Deviation|Mean
1325309|NCT02186873|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16|The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of “yes” on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on Scale||Standard Deviation|Mean
1325310|NCT02186873|Secondary|Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16|Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient’s global assessment of disease activity, total back pain, function (BASFI), inflammation.|Week 16|FAS included all participants who were randomized in the study.|||Percentage of Participants|||Number
1325311|NCT02186873|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16|The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
1325312|NCT02186873|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16|The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
1325313|NCT02186873|Primary|Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16|ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient’s global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.|Week 16|The full analysis set (FAS) included all participants who were randomized in the study.|||Percentage of Participants|||Number
1325314|NCT02186873|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16|The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
1325315|NCT02186873|Secondary|Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16|The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.|Week 16|FAS included all participants who were randomized in the study.|||Percentage of Participants|||Number
1325316|NCT02186873|Secondary|Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16|An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.|Week 16|FAS included all participants who were randomized in the study.|||Percentage of Participants|||Number
1325317|NCT02186808|Secondary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.|prosthesis delivery, 5 years|5 year data. Not all initially treated patients could be followed over the 5 years.|||percentage of successful implants|Participants||Number
1325318|NCT02186808|Primary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.|prosthesis delivery, 1 year|78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.|||percentage of successful implants|Participants||Number
1325319|NCT02186665|Primary|Success of Investigator's Global Assessment (IGA)|"The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).~The IGA was evaluated at each visit on the following 0 to 4 point scale:~0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation~- Almost Clear: Just perceptible erythema, no induration, and no scaling~- Mild: Mild erythema, no induration, and mild or no scaling~- Moderate: Moderate erythema, mild induration, and mild or no scaling~- Severe: Severe erythema, moderate to severe induration, and scaling of any degree"|Baseline to Week 8|ITT: All randomized subjects to whom study medication was dispensed.|||Participants|||Count of Participants
1325320|NCT02186587|Primary|Distance Measured During 6-minute Walk Test|Subjects will walk for 6 minutes and the distance covered will be measured in feet.|6 months||||feet||Standard Deviation|Mean
1325321|NCT02186223|Secondary|Incidence of PEs Averted|During the pre-removal cavogram, the presence of significant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.|During the pre-removal cavogram (An average of 6.8 days after device insertion)||||Participants|||Count of Participants
1325322|NCT02186223|Secondary|Incidence of Major Bleeding Event||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
1325323|NCT02186223|Secondary|Incidence of Catheter Related Blood Stream Infections||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
1325324|NCT02186223|Secondary|Incidence of Catheter Related Thrombosis||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
1325326|NCT02186223|Primary|Freedom From Clinically Significant PE or Fatal PE During Treatment Period|"Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.~Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death."|Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
1325327|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 24 hour diameter)/24 hour diameter × 100.|24 hours after infusion||||percentage of brachial artery diameter||Standard Error|Mean
1325328|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 4 hour diameter)/4 hour diameter × 100.|4 hours after infusion||||percentage of brachial artery diameter||Standard Error|Mean
1325329|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline||||percentage of brachial artery diameter||Standard Error|Mean
1325330|NCT02185534|Secondary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))|Comparison of the pharmacokinetic profile in terms of the area under the plasma concentration-curve from time zero to the time of last quantifiable clopidogrel or SR26334 concentration, AUC(0-last), of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325331|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)|Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325332|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))|Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of clopidogrel sourced in Europe and Japan.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US). AUC(0-inf) could not be reliably calculated for many of these subjects.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1325333|NCT02185339|Other Pre-specified|Postoperative Pain|"Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by “no pain” (score of 0) and “pain as bad as it could be” (score of 10).~Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h."|Postoperative 2 days||||Scores on a scale||Standard Deviation|Mean
1325334|NCT02185339|Other Pre-specified|Surgical Condition|Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)|At completion of pneumoperitoneum surgery||||Participants|||Number
1325335|NCT02185339|Other Pre-specified|Cardiac Index|"Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative||||L/min/m^2||Standard Deviation|Mean
1325336|NCT02185339|Other Pre-specified|Stroke Volume Variation|"Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative||||% of mean stroke volume||Standard Deviation|Mean
1325337|NCT02185339|Secondary|Pulmonary Shunt|"Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative||||% of shunt||Standard Deviation|Mean
1325338|NCT02185339|Secondary|Estimated Dead Space|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative||||% of respiratory dead space||Standard Deviation|Mean
1325339|NCT02185339|Secondary|Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative||||mmHg||Standard Deviation|Mean
1325340|NCT02185339|Secondary|Arterial Oxygen Tension/Inspired Oxygen Fraction|Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative||||mmHg||Standard Deviation|Mean
1325341|NCT02185339|Primary|Thoracopulmonary Compliance|"Was measured with a patient spirometry monitor through a flow sensor.~Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP)."|intraoperative||||ml/cmH2O||Standard Deviation|Mean
1325342|NCT02185183|Primary|Number of Participants With Improved in Disease Activity||15 weeks||||participants|||Number
1325343|NCT02185131|Primary|Level of Depressive Symptoms|Level of depressive symptoms, as indicated by the score on the Beck Depression Inventory. The Beck Depression Inventory II scoring range is as follows: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms and 29-63 severe depressive symptoms.|12 Weeks||||Units on a scale||Standard Deviation|Mean
1325344|NCT02185131|Primary|Drinks Per Drinking Day|Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.|12 Weeks||||Drinks per drinking day||Standard Deviation|Mean
1325345|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Inferior)|Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325346|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Temporal)|Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325347|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Superior)|Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325348|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Nasal)|Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325349|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Inferior)|Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325350|NCT02185105|Primary|Anterior Ocular Health - CornealStaining (Superior)|Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325351|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Temporal)|Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325352|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Nasal)|Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325353|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Central)|Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
1325354|NCT02185105|Primary|Lens Fitting - Rotation/Mislocation|Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).|Baseline, 15min & 6hrs||||degrees||Standard Deviation|Mean
1325355|NCT02185105|Primary|General Lens Fit - Fit Acceptance|Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
1325356|NCT02185105|Primary|Investigator's Assessment of Stability|Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.|15min & 6hrs||||degrees||Standard Deviation|Mean
1325357|NCT02185105|Primary|Subjective Rating For Handling - Removal|Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)|1 min||||units on a scale||Standard Deviation|Mean
1325358|NCT02185105|Primary|Subjective Rating For Handling - Insertion|Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)|1 min||||units on a scale||Standard Deviation|Mean
1325359|NCT02185105|Primary|Subjective Rating For Comfort Preference|Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)|1min, 15min, 3hrs, 6hrs||||percentage of subjects|||Number
1325360|NCT02185105|Primary|Subjective Rating For Comfort - Comfort Since Last Visit|Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)|15min, 3hrs, 6hrs||||units on a scale||Standard Deviation|Mean
1325361|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Acceptance|Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
1325362|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Deposits|Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
1325363|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Wettability|Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
1325364|NCT02184624|Secondary|Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire|After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported|Day 1|Modified Intent-to-Treat Population.|||Percentage of participants|||Number
1325365|NCT02184624|Secondary|Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire|After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.|Day 1|Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis.|||Percentage of participants|||Number
1325366|NCT02184624|Secondary|Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique|If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.|Day 1|Modified Intent-to-Treat Population|||Participants|||Number
1325367|NCT02184624|Secondary|Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP|An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.|Day 1|Modified Intent-to-Treat Population.|||Percentage of participants|||Number
1325368|NCT02184624|Secondary|Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP|A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.|Day 1|Modified Intent-to-Treat Population|||Percentage of participants|||Number
1325369|NCT02184624|Secondary|Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet|An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.|Day 1|Modified Intent-to-Treat Population.|||Percentage of participants|||Number
1325370|NCT02184624|Primary|Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet|A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.|Day 1|Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet.|||Percentage of participants|||Number
1325371|NCT02184572|Secondary|Number of Subjects Reporting Measles-like Illness|"Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:~maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea."|During Day 5 to Day 12 post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325372|NCT02184572|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|Day 0 through the end of the study (Day 180)|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325396|NCT02184208|Primary|Successful Extubation|Successful extubation without the use of noninvasive ventilation or requiring reintubation|Within 24 hours of extubation||||Participants|||Count of Participants
1325373|NCT02184572|Secondary|Number of Subjects Reporting AEs of Specific Interest|AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.|Day 0 through the end of the study (Day 180)|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325374|NCT02184572|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any ‘solicited’ AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325375|NCT02184572|Secondary|Number of Subjects Reporting MMR Specific Solicited General AEs|Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325376|NCT02184572|Secondary|Number of Subjects Reporting Any Rash|Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325377|NCT02184572|Secondary|Number of Subjects Reporting Any Fever|Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325378|NCT02184572|Secondary|Number of Subjects With Any Solicited General AEs|Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 15-day (Days 0-14) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325379|NCT02184572|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325380|NCT02184572|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||IU/mL||95% Confidence Interval|Geometric Mean
1325381|NCT02184572|Secondary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration < 4 IU/mL) before vaccination.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
1325382|NCT02184572|Secondary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.|At Day 42 post vaccination|According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps, or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||EU/mL||95% Confidence Interval|Geometric Mean
1325383|NCT02184572|Secondary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration < 5 EU/mL) before vaccination.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
1325384|NCT02184572|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||mIU/mL||95% Confidence Interval|Geometric Mean
1325397|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for HCTZ|Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1326013|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|90 days||2018-12-31|12/2018||||
1325385|NCT02184572|Secondary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before vaccination.|At Day 42 post vaccination|According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
1325386|NCT02184572|Primary|Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination|Fever was assessed for temperature equal to/above (≥) 38.0°C and above (>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.|During Day 5 to Day 12 post-vaccination period|Analysis was performed on Total Vaccinated cohort (TVC) which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
1325387|NCT02184494|Other Pre-specified|Fatigue/Depression Assessment|"Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.~Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms."|Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus unable to be added to analysis.|||units on a scale||Standard Deviation|Mean
1325388|NCT02184494|Other Pre-specified|Health and Activity Questionnaire|"Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant’s degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.~Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant’s ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence."|Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus, clearly unable to be added to analysis.|||units on a scale||Standard Deviation|Mean
1325389|NCT02184494|Other Pre-specified|Neurological Function|Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.|Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.|The MS and healthy, older adults populations were not required to be assessed with the UPDRS because the assessment materials were for PD populations, specifically.|||units on a scale||Standard Deviation|Mean
1325390|NCT02184494|Secondary|Resting Energy Expenditure|Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.|Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.|"1 of the 12 PD participants had severe claustrophobia, and could not tolerate the breathing mask on their face.~1 of the 12 PD participants, and 1 of the 8 healthy, older adults participants: dysfunctional equipment, and thus invalid results."|||kcal||Standard Deviation|Mean
1325391|NCT02184494|Primary|Blood Lactate Response|Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise|Before, immediately after, and 10 minutes after the squatting exercise protocol|"2 of the 8 participants in the healthy, older adults group did not return for this visit, and thus, were not included in analysis.~1 of the 12 MS participants did not return for this visit, and thus, were not included in analysis."|||mmol/L||Standard Deviation|Mean
1325392|NCT02184442|Secondary|Effective Orifice Area - Change From Baseline||1 Year|Valve Implant Population; Please note that echo data was not available for all patients.|||cm^2||Standard Deviation|Mean
1325393|NCT02184442|Secondary|Total Aortic Regurgitation - Change From Baseline|"Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.~Total regurgitation at one year was analyzed in the valve implant population."|1 Year|Please note that all the valve-implant population do not have echo data.|||Grade||Standard Deviation|Mean
1325394|NCT02184442|Secondary|NYHA Classification - Change From Baseline|New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.|Baseline and 1 Year|Please note that all the patients were not available for a NYHA functional assessment|||Units on a scale||Standard Deviation|Mean
1325395|NCT02184442|Primary|Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization|All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year|1 Year||||participants|||Number
1325398|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for HCTZ|Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325399|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Amlodipine|Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1325400|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Amlodipine|Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325401|NCT02183675|Secondary|Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours|Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state|0-6 hours (h), 6-12h and 12-24h after drug administration on day 10|PK set|||mg||Geometric Coefficient of Variation|Geometric Mean
1325402|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Telmisartan|Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1325403|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Telmisartan|Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325404|NCT02183519|Primary|Peak Expiratory Flow Rate|Peak expiratory flow rate is the maximum volume of air that is expelled per unit time for each cough in a cough epoch. Measured in liters/second.|1-2 hours||||Liters of air/second||Standard Deviation|Mean
1325405|NCT02182999|Secondary|Patient's Overall Satisfaction With Pain Management|Patient satisfaction with pain management was investigated on a numeric rating scale (NRS; scale 0-10) as part of routine examination 6 weeks after the procedure. Higher numbers indicate higher patients satisfaction.|6 weeks||||units on a scale||Standard Deviation|Mean
1325406|NCT02182999|Secondary|Patient's Overall Satisfaction With Surgery|Patient satisfaction with surgery was investigated on a numeric rating scale (NRS; scale 0-10) as part of routine examination 6 weeks after the procedure. Higher numbers indicate higher patients satisfaction.|6 weeks||||units on a scale||Standard Deviation|Mean
1325407|NCT02182999|Secondary|American Orthopaedic Foot and Ankle Society Score (AOFAS)|The American Orthopedic Foot and Ankle Society Score (AOFAS-Score, Forefoot Version) is comprised of nine questions and coveres three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. The scale ranges from 0 to 100, with higher values representing a better outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
1325408|NCT02182999|Primary|Peak Postoperative Numeric Rating Scale (NRS) for Pain|The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were assessed by members of the nursing staff every 4 hours for 48 hours after the procedure (until discharge). Patients were instructed to rate their pain level on a scale from 0 to 10, with 0 meaning “no pain” and 10 indicating “pain as bad as it could be”. Peak postoperative numeric rating scale (NRS) for pain was calculated for each group (Placebo, Ropivacaine) by adding the highest recorded NRS score for pain of all patients in each group (Placebo, Ropivacaine) to obtain the mean peak postoperative NRS score.|First 48 postoperative hours||||units on a scale||Standard Deviation|Mean
1325409|NCT02182999|Primary|Average Postoperative Numeric Rating Scale (NRS) for Pain|The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were assessed by members of the nursing staff every 4 hours for 48 hours after the procedure (until discharge). Patients were instructed to rate their pain level on a scale from 0 to 10, with 0 meaning “no pain” and 10 indicating “pain as bad as it could be”. Average postoperative numeric rating scale (NRS) for pain was calculated for each group (Placebo, Ropivacaine) by adding all postoperative NRS scores of all patients in each group (Placebo, Ropivacaine) to obtain the mean postoperative NRS score.|First 48 postoperative hours||||units on a scale||Standard Deviation|Mean
1325410|NCT02182895|Secondary|Patient Satisfaction|Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.|At the time of discharge or Day 5||||Score||Standard Deviation|Mean
1325411|NCT02182895|Secondary|Length of Hospital Stay|Number of days in hospital|Admission to discharge, an expected average of 5 days|completed|||days||Standard Deviation|Mean
1325412|NCT02182895|Secondary|Variability in Glucose Levels|Mean amplitude of glycemic excursions|Days 2 to 5|Patients who allowed a CGMS.|||mmol/L||Standard Deviation|Mean
1325413|NCT02182895|Secondary|Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)|Proportion of BG readings in the severe hyperglycemic range.|Days 2 to 5|completed|||% of blood glucose readings >200|||Number
1325414|NCT02182895|Secondary|Incidence of Hypoglycemia (BG <70 mg/dL)|Number of BG readings <70 mg/dL in each group|Days 2 to 5|completed|||number of events|||Number
1325415|NCT02182895|Secondary|Dose of Insulin|Average daily amount of insulin used|Days 2 to 5|completed subjects|||Units||Standard Deviation|Mean
1325418|NCT02182830|Secondary|Change From Baseline in Trough Seated DBP (mmHg) at Week 24|"Change from baseline in trough seated DBP (mmHg) at Week 24 is secondary endpoint. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
1325419|NCT02182830|Secondary|Change From Baseline in Trough Seated DBP (mmHg) at Week 12|"Change from baseline in trough seated DBP (mmHg) at Week 12 is secondary endpoint. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 12 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
1325420|NCT02182830|Secondary|Change From Baseline in Trough Seated SBP (mmHg) at Week 24|"Change from baseline in trough seated SBP (mmHg) at Week 24 is secondary endpoint. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
1325421|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24|"Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 24 is secondary endpoint. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
1325422|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12|"Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 12. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 12 weeks|FAS (LOCF-H)|||mmHg||Standard Error|Mean
1325423|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24|"Change from baseline in mean 24-hour ambulatory SBP (mmHg) at Week 24 is secondary endpoint. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
1325424|NCT02182830|Secondary|Change From Baseline in Trough Seated SBP at Week 12|"Change from baseline in trough seated SBP (mmHg) at Week 12 is presented. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 12 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
1325425|NCT02182830|Secondary|Change From Baseline in Body Weight at Week 24|"Changes from baseline in body weight at Week 24 is presented. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 24 weeks|FAS OC|||kilogram (kg)||Standard Error|Mean
1325426|NCT02182830|Secondary|Changes From Baseline in Trough Mean Ambulatory SBP at Week 12|"Changes from baseline in trough mean ambulatory SBP at Week 12 is presented. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 12 weeks|FAS LOCF-H|||millimeter of mercury (mmHg)||Standard Error|Mean
1325427|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12|"Change from baseline in mean 24-hour ambulatory Systolic blood pressure SBP at Week 12 is presented. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 12 weeks|FAS LOCF-H; LOCF-H= Last observation carried forward without values following antidiabetic rescue medication and/or a change in antihypertensive therapy|||millimeter of mercury (mmHg)||Standard Error|Mean
1325428|NCT02182830|Primary|Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks|"Change from baseline in HbA1c (%) at 24 weeks is presented. The term “baseline” refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis."|baseline and 24 weeks|"Full analysis set (FAS) observed cases (OC); FAS: All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value.~Observed cases will set all values measured after antidiabetic rescue medication to missing"|||percentage of glycated haemoglobin||Standard Error|Mean
1325429|NCT02182115|Primary|Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.|Participants with no SA post-treatment, proportion (%) of participants in each study arm that had no SA detected on the post-treatment cultures from the 4 body sites sampled with swab cultures.|Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.||||Participants|||Count of Participants
1325430|NCT02181790|Primary|Change in Dermatology Life Quality Index (DLQI) at Week 8 From Baseline|reduction in DLQI from baseline after 16 treatments with the excimer laser in the first phase of the study|baseline and week 8|study terminated before study completion, no data collected||||||
1325431|NCT02181790|Primary|Psoriasis Area and Severity Index (PASI)|The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) from baseline after 16 treatments with the excimer laser in the first phase of the study.|baseline and week 12|study terminated before study completion, no data collected||||||
1325440|NCT02181673|Secondary|Percentage of Participants Who Achieved an ACR 50 Response at Week 14|The ACR 50 response is defined as: greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 14|The full analysis set (FAS) included all participants who were randomized.|||Percentage of Participants|||Number
1333293|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for headache.|24 hours||||Participants|||Count of Participants
1325432|NCT02181673|Secondary|Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline and Week 14|"The full analysis set (FAS) included all participants who were randomized. Here N (number of participants analyzed) signifies the number of participants evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1325433|NCT02181673|Secondary|Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14|The ACR 70 response is defined as greater than or equal to (>=) 70 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=70% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 14|The full analysis set (FAS) included all participants who were randomized.|||Percentage of participants|||Number
1325434|NCT02181673|Secondary|Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24|The ACR 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 24|The full analysis set (FAS) included all participants who were randomized.|||Percentage of participants|||Number
1325435|NCT02181673|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline and Week 14|"The full analysis set (FAS) included all participants who were randomized. Here N (number of participants analyzed) signifies the number of participants evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1325436|NCT02181673|Secondary|Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline|Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.|Baseline and Week 14|"Population included all Randomized participants With Dactylitis (Score >0) at Baseline. Here N (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1325437|NCT02181673|Secondary|Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline|Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).|Baseline and Week 14|"Population included all randomized participants with Enthesitis at Baseline. Here N (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1325438|NCT02181673|Secondary|Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.|Baseline and Week 24|FAS for structural damage endpoints (FAS-SD) defined as participants in the FAS who were treated and had a non-missing baseline total modified vdH-S score for the analysis.|||units on a scale||Standard Error|Mean
1325439|NCT02181673|Secondary|Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.|Week 14|The analysis set included randomized participants with greater than or equal to (>=) 3 percent (%) body surface area (BSA) Psoriasis Skin Involvement at Baseline.|||Percentage of participants|||Number
1325441|NCT02181673|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 14|"The full analysis set (FAS) included all participants who were randomized. Here N (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1325442|NCT02181673|Primary|Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14|The ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 14|The full analysis set (FAS) included all participants who were randomized.|||Percentage of Participants|||Number
1325443|NCT02181634|Other Pre-specified|Banking Biospecimens for Future Assessment|Optional specimen banking of patient blood specimens (including serum, plasma and buffy coat) as well as fixed left-over tissue specimens when available from all enrolled patients in this trial for possible future molecular, pharmacogenomic, and/or proteomic testing.|Prior to Cycle 1, Day 1; Cycle 1, Day 8; Cycle 3, Day 1 and at Off Treatment|||||||
1325444|NCT02181634|Other Pre-specified|hENT Expression|Correlate hENT1 (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
1325445|NCT02181634|Other Pre-specified|CDA Expression|Correlate CDA (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
1325446|NCT02181634|Other Pre-specified|Fibrosis Expression|Correlate fibrosis (low, intermediate and high) by trichrome staining with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
1325447|NCT02181634|Other Pre-specified|Stromal SPARC Expression|Correlate stromal SPARC (high versus low) expression by immunohistochemistry (IHC) with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
1325448|NCT02181634|Other Pre-specified|Change in Circulating Tumor Cells (CTCs)|Correlate change in CTCs to median PFS, OS, TTP, ORR and DCR.|Prior to Cycle 1, Day 1; Cycle 1 Day 8; Cycle 3, Day 1 and at Off Treatment|||||||
1325449|NCT02181634|Secondary|Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline|Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between OS and maximum change in CA 19-9.|CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment|Eligible and treated patients with CA 19-9 data available|||months||95% Confidence Interval|Median
1325450|NCT02181634|Secondary|Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline|Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between PFS and maximum change in CA 19-9.|CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment|Eligible and treated patients with CA 19-9 data available|||months||95% Confidence Interval|Median
1325451|NCT02181634|Secondary|Disease Control Rate (DCR)|Disease control rate is the proportion of patients achieved complete response, partial response or stable disease per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. Stable disease is defined as neither sufficient shrinkage to qualify for complete or partial response nor sufficient increase to qualify for progression. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.|Every 3-6 months for up to 3 years|Eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
1325452|NCT02181634|Secondary|Overall Response Rate (ORR)|Overall response rate is defined as the proportion of patients with complete response or partial response per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.|Every 3-6 months for up to 3 years|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
1325453|NCT02181634|Secondary|Time To Progression (TTP)|TTP was defined as the time from date of first dose of study therapy to date of removal from study for progression. Patients who have not experienced progression were censored at the date of last disease evaluation. Progression is evaluated using Solid Tumor Response Criteria (RECIST) Version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters/axes of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm over the nadir. The appearance of new lesions or unequivocal progression of existing non-target lesions also constitutes disease progression.|Every 3-6 months for up to 3 years|Eligible and treated|||months||95% Confidence Interval|Median
1325454|NCT02181634|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first.|Every 3-6 months for up to 3 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1325455|NCT02181634|Secondary|Overall Survival (OS)|OS is defined as the time from enrollment until death or last patient contact.|Every 3-6 months for up to 3 years|Eligible and treated|||months||95% Confidence Interval|Median
1325487|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia||2 weeks|||||||
1325456|NCT02181634|Primary|Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)|"Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions."|Assessed at 6 months|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
1325457|NCT02181530|Secondary|Time to OZURDEX® Re-Injection in the Study Eye||Up to 17 Months|All participants who had OZURDEX® re-injection.|||days||Standard Deviation|Mean
1325458|NCT02181530|Secondary|Time to Improvement of 3 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported.|Baseline, Up to 17 Months|All participants with improvement of 3 lines or more in BCVA.|||days||Standard Deviation|Mean
1325459|NCT02181530|Secondary|Time to Improvement of 2 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported.|Baseline, Up to 17 Months|All participants with improvement of 2 lines or more in BCVA.|||days||Standard Deviation|Mean
1325460|NCT02181530|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the given time-point.|||μm||Standard Deviation|Mean
1325461|NCT02181530|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 17 Months|All participants.|||percentage of participants|||Number
1325462|NCT02181530|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye|BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as “approxETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 17 Months|All participants.|||percentage of participants|||Number
1325463|NCT02181530|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the time-point.|||units on a scale||Standard Deviation|Mean
1325464|NCT02181517|Secondary|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 16, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||microns||Standard Deviation|Mean
1325465|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||percentage of participants|||Number
1325466|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||percentage of participants|||Number
1325467|NCT02181517|Secondary|Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||letters||Standard Deviation|Mean
1325468|NCT02181517|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit.|||letters||Standard Deviation|Mean
1325469|NCT02181504|Secondary|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening.|Baseline, Week 16, Week 20|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||microns||Standard Deviation|Mean
1325470|NCT02181504|Secondary|Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥10 letters are noted.|Baseline, 20 Weeks|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Percentage of Patients|||Number
1325471|NCT02181504|Secondary|Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥15 letters are noted.|Baseline, 20 Weeks|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Percentage of Patients|||Number
1325472|NCT02181504|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.|Baseline, Week 20|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Letters||Standard Deviation|Mean
1325473|NCT02181504|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.|Baseline, Week 16|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Letters||Standard Deviation|Mean
1325474|NCT02181426|Primary|PACU Opiate Consumption|Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).|Less than 1 day (PACU stay in the postoperative period)|The study enrolled 112 patient with 28 patients randomized to each group.|||IV Morphine Equivalents (mg)||Standard Error|Mean
1325475|NCT02181387|Primary|Neuraxial Analgesic Drug Consumption Per Hour|subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery.|up to 24 hours||||milliliters||Standard Deviation|Mean
1325476|NCT02181140|Secondary|Complication Rates|Complication rates of EUS FNA|day 0 and day 14||||participants|||Number
1325477|NCT02181140|Secondary|EUS Pro Core FNA: Histology Samples|Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples|day 0 and day 14|Histology (not cytology) samples for Pro-core Needle|||participants|||Number
1325478|NCT02181140|Primary|Diagnostic Accuracy|"Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts.~The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard."|up to 1 year||||Diagnostic accuracy (%)|||Number
1325479|NCT02181127|Secondary|Documented Episodes of Nausea and Fraction on Glucagon vs. Placebo Days||2 weeks|||||||
1325480|NCT02181127|Secondary|Total Glucagon Dosing (mcg/kg/24 Hours)||2 weeks|||||||
1325481|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM – 7:00 AM)||2 weeks|||||||
1325482|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM – 7:00 AM)||2 weeks|||||||
1325483|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM – 11:00 PM)||2 weeks|||||||
1325484|NCT02181127|Secondary|• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM – 11:00 PM)||2 weeks|||||||
1325485|NCT02181127|Secondary|Insulin Total Daily Dose||2 weeks|||||||
1325486|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia||2 weeks|||||||
1325500|NCT02181127|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements.|"Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean):~< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl"|2 weeks|||||||
1325501|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 70 mg/dl||2 weeks|||||||
1325502|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 60 mg/dl||2 weeks|||||||
1325503|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 50 mg/dl||2 weeks|||||||
1325504|NCT02181127|Secondary|Time With CGM Glucose Less Than 70 mg/dl Overnight and During Daytime||2 weeks|||||||
1325505|NCT02181127|Primary|Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl||From t=0 to study stop after 2 weeks||||mg/dl/min||Standard Deviation|Mean
1325506|NCT02180893|Secondary|Participant Satisfaction Score|Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)|48 hours||||units on a scale||Standard Deviation|Mean
1325507|NCT02180893|Secondary|Participant Satisfaction|Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)|48 hours||||"percentage of yes responders"|||Number
1325508|NCT02180893|Primary|Visual Analog Scale (VAS) Pain Scores|Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain|24 hours||||units on a scale||Standard Deviation|Mean
1325509|NCT02180893|Primary|Postoperative Fentanyl||24 hours||||microgram/kilogram||Standard Deviation|Mean
1325510|NCT02180828|Secondary|Total Adverse Events|Total adverse events(cases)|at day 7-14 follow up||||participants|||Number
1325511|NCT02180828|Secondary|Adverse Events 4|Skin sensitivity, urticaria rash, erythematous rash, irritation|at day 7-14 follow up||||participants|||Number
1325512|NCT02180828|Secondary|Adverse Events 3|Gastrointestinal tract: abdominal pain, diarrhoea, nausea|at day 7-14 follow up||||participants|||Number
1325513|NCT02180828|Secondary|Adverse Events 2|Vulvovaginal pruritus, burning, irritation, and bleeding|at day 7-14 follow up||||participants|||Number
1325514|NCT02180828|Secondary|Adverse Events 1|Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.|at day 7-14 follow up||||participants|||Number
1325515|NCT02180828|Primary|Therapeutic Efficacy 4|Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.|at days30-35 follow-up||||participants|||Number
1325516|NCT02180828|Primary|Therapeutic Efficacy 3|Mycological cure of clotrimazole group and fluconazole group|at days 7-14 follow-up||||participants|||Number
1325517|NCT02180828|Primary|Therapeutic Efficacy 2|The clinical cure rates of clotrimazole and fluconazol|at days 30-35 follow-up||||participants|||Number
1325518|NCT02180828|Primary|Therapeutic Efficacy 1|The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.|7-14 days after treatment (=visit 2)|PPS|||participants|||Number
1325519|NCT02180646|Other Pre-specified|Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||2018-08-31|08/2018||||
1325520|NCT02180646|Other Pre-specified|Post-meal Insulin Level (AUC [0-4])|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||||min*pg/ml||Standard Error|Mean
1325521|NCT02180646|Secondary|Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||||min*pg/ml||Standard Error|Mean
1325522|NCT02180646|Primary|Plasma Glucose Level Post-meal (AUC [0-4])|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||||min*pg/ml||Standard Error|Mean
1325523|NCT02180438|Other Pre-specified|Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events||24 weeks||||Participants|||Count of Participants
1325524|NCT02180438|Other Pre-specified|Interim Analysis at 24 Weeks of HIV-2 Virologic Failure|Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml)|24 weeks||||Participants|||Count of Participants
1325525|NCT02180438|Other Pre-specified|Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event||24 weeks||||Participants|||Count of Participants
1325526|NCT02180438|Other Pre-specified|Interim 24 Weeks Analysis of Death||24 weeks||||participants|||Number
1325527|NCT02180438|Secondary|Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF||48 weeks||||Participants|||Count of Participants
1325528|NCT02180438|Secondary|Switching Off Stribild Prior to 48 Weeks||48 Weeks||||Participants|||Count of Participants
1325529|NCT02180438|Secondary|< 50 CD4 T-cell Increase at 48 Weeks From Baseline||48 weeks||||Participants|||Count of Participants
1325530|NCT02180438|Secondary|CD4 T-cell Count at 48 Weeks < Baseline||48 weeks||||Participants|||Count of Participants
1325531|NCT02180438|Secondary|Grade 3 or 4 Adverse Events|Adverse event per NIH/DAIDS criteria|48 weeks||||Participants|||Count of Participants
1325532|NCT02180438|Primary|Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)||48 weeks||||Participants|||Count of Participants
1325533|NCT02180438|Primary|New WHO Stage 3 or 4 Event|New AIDS defining event per WHO criteria|48 weeks||||Participants|||Count of Participants
1325534|NCT02180438|Primary|Death|Number of Participants Experiencing Death within the study period|48 weeks||||Participants|||Count of Participants
1325597|NCT02178475|Secondary|Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis|The number of participants who received pegfilgrastim prophylaxis from cycle 1 until a cycle when other G-CSF prophylaxis was administered, and this G-CSF or a different G-CSF agent (not pegfilgrastim) was received as prophylaxis at each remaining cycle of the chemotherapy course.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||participants|||Number
1325535|NCT02180230|Secondary|Cumulative Survival Rates of the Implants|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|implant insertion to follow-up visits (6, 12, 36 and 60 months)|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.|||percentage of surviving implants|Participants||Number
1325536|NCT02180230|Primary|Marginal Bone Remodeling|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.~Missing data was not imputed and not included in evaluation."|from implant insertion to 6, 12, 36 and 60 months|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.|||mm|Participants|Standard Deviation|Mean
1325537|NCT02180061|Secondary|ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC)|The ORR, using irRC, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (irCR; complete disappearance of all tumor lesions, whether measureable or not, and no new lesions) or a Partial Response (irPR; decrease in sum of the products of the 2 largest perpendicular diameters of 50% or greater) at any time during the study, based on central radiology review.|Up to 24 months|The FAS population consisted of all allocated participants who had irRC measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1325538|NCT02180061|Secondary|ORR Per Investigator Assessment Using RECIST 1.1|The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.|Up to 24 months|The FAS population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by Investigator review and received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1325539|NCT02180061|Primary|Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Up to 24 months|The Full Analysis Set (FAS) population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1325540|NCT02180061|Primary|Number of Participants Discontinuing Treatment Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to last dose of study drug (Up to 24 months)|The APaT population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1325541|NCT02180061|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1325542|NCT02179892|Secondary|Mean Time of First Opioid Use|The time of first opioid use after surgery will be recorded for up to 72 hours.|Post-surgery (Up to 72 Hours)||||hours||Standard Deviation|Mean
1325543|NCT02179892|Secondary|Mean Visual Analogue Scale (VAS) Pain Score With Movement|The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.|Post-Surgery 24 Hours, 48 Hours, 72 Hours||||units on a scale||Standard Deviation|Mean
1325544|NCT02179892|Secondary|Mean Visual Analogue Scale (VAS) Pain Score at Rest|The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.|Post-Surgery 24 Hours, 48 Hours, 72 Hours||||units on a scale||Standard Deviation|Mean
1325545|NCT02179892|Primary|Mean Opioid Consumption|The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.|Post Surgery (Up to 72 Hours)||||milligrams||Standard Deviation|Mean
1325546|NCT02179424|Secondary|Smoking Reduction|Reduced at least 50% of cigarette consumption|6 month follow-up and 12 month follow-up||||participants|||Number
1325547|NCT02179424|Primary|Smoking Quit Rate|smoking quit rate was defined as the self-reported 7-day point prevalence abstinence|6 month follow-up and 12 month follow-up|In Phase 2, a sample of 642 employees enrolled in the study and chose 1 among the 4 conditions for smoking cessation.|||participants|||Number
1325630|NCT02177136|Primary|Change From Baseline in Serum Alkaline Phosphatase (ALP)|The primary efficacy analysis will compare the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate.|Baseline and 24 weeks|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
1326128|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
1325548|NCT02179424|Primary|Employers' KAP|"A questionnaire aimed to examine the employers'/ managerial staff’s knowledge, attitudes and practices in promoting smoking cessation in the workplace.~The questionnaires consist of three parts:~Employers's knowledge was assessed by measuring the average number of correct answers on questions about smoking and quitting (Scale 1-7).~Employers' attitude was assessed by measuring the average number agreeing items about their willingness to support employees to quit which included implementation of measures to show support for smoking cessation in the workplace or participation in smoking cessation programme (Scale 1-17).~Employers' practice was assessed by the level of smoking ban in the workplace as reported by the employer. (Scale 1-4; 1: not prohibited, 2: prohibited by not strictly, 3: Strictly prohibited and 4: absolutely strictly prohibited)."|Before the health talk|In Phase 1, questionnaires were sent out to 580 companies and 292 of the company employers returned the complete questionnaire. These 292 employers were not participating in the Phase 2 of this study.|||units on a scale||Standard Deviation|Mean
1325549|NCT02179398|Secondary|Specificity of Standard Biological Marker for SBI|Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation||||percentage of patients (specificity)||95% Confidence Interval|Number
1325550|NCT02179398|Secondary|Sensitivity of Standard Biological Marker for SBI|Sensitivity of standard biological marker for SBI: WBC ≥ 15’000/mm³ and/or bands ≥ 1’500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation||||percentage of patients (sensitivity)||95% Confidence Interval|Number
1325551|NCT02179398|Secondary|Specificity of a Lab-score ≥ 3||at 72 hours from PED presentation||||percentage of patients (specificity)||95% Confidence Interval|Number
1325552|NCT02179398|Secondary|Sensitivity of a Lab-score ≥ 3||at 72 hours from PED presentation||||percentage of patients (sensitivity)||95% Confidence Interval|Number
1325553|NCT02179398|Secondary|Hospitalization Rate||at PED presentation||||participants|||Number
1325554|NCT02179398|Secondary|Presence of Serious Bacterial Infection||at 72 hours from PED presentation||||participants|||Number
1325555|NCT02179398|Primary|Antibiotic Prescription Rate||at PED (Pediatric Emergency Department) presentation|children 7 days – 36 months old presenting to the PED with fever without source (FWS) ≥38.0°C (≥ 100.4°F) after a thorough history and careful examination|||participants|||Number
1325556|NCT02178995|Post-Hoc|Hit Reaction Time (Open-Label)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.||||Milliseconds||Standard Deviation|Mean
1325557|NCT02178995|Post-Hoc|Hit Reaction Time (Double Blind)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.||||ms||Standard Deviation|Mean
1325558|NCT02178995|Post-Hoc|Remaining CPT Variables (Double-blind Portion)|"Remaining CPT variables are automatically calculated by the program. They were not pre-specified variables of interest nor intentional post-hoc analyses. They are included ONLY for completeness of data submission.~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Placebo vs 10mg vs 20mg (visits 2, 3, 4)||||Units||Standard Deviation|Mean
1325559|NCT02178995|Post-Hoc|Remaining CPT Variables (Open-label)|"These are automatically-calculated CPT variables which were not pre-specified variables of interest or intentional post-hoc analyses. They are included ONLY for completeness of data. They include hit reaction time (HRT), variability (VAR), and perseverations (PRS).~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Baseline vs end of open-label (week 8)|Note: One participant's CPT data was invalid|||Units||Standard Deviation|Mean
1325560|NCT02178995|Post-Hoc|QOLIE-89 Additional Subscales (Open-label)|"These are the remaining subscales of the QOLIE-89. These were not pre-specified variables of interest or intentional post-hoc analyses, but are automatically calculated in scoring the QOLIE-89 and are included ONLY for completeness of data submission.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Visit 1 (baseline) vs end of open-label (week 8)||||Points||Standard Deviation|Mean
1325598|NCT02178475|Secondary|Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred|The number of chemotherapy cycles during which complications of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Cycles of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered, in which no G-CSF prophylaxis was administered.|||cycles|cycles||Number
1325561|NCT02178995|Other Pre-specified|Neuropsychiatric Questionnaires|"Beck Depression Inventory, Beck Anxiety Inventory, Apathy Evaluation Scale. These were not primary or secondary variables of interest given methylphenidate's primary expected action being on cognition. Included given one author's interest, as other studies suggesting psychiatric improvements (particularly apathy and depression) with methylphenidate.~BDI is a common clinical and research measure of depression. It has 21 questions and is scored 0 (no depression) to 63 (most severe depression). A higher score is worse.~BAI is a measure of anxiety, which also has 21 questions and is scored 0 (no anxiety) to 63 (most severe anxiety). A higher score is worse.~AES is a measure of clinical apathy, and is an 18-item scale. It rates symptoms as not at all, slightly, somewhat, or a lot, which are then converted to numerical values 1 (least apathy) to 4 (most apathy). Scores range from 18 (no apathy) to 72 (most apathy)."|Baseline (Visit 1) vs end of Open-label (week 8)||||Points||Standard Deviation|Mean
1325562|NCT02178995|Other Pre-specified|Stimulant Side-effects Checklist|"This is a questionnaire covering common stimulant side-effects, intended to help monitor for any significant or common adverse effects.~The scale lists 16 common stimulant side effects rated 0 (absent) to 9 (serious). Minimum score is 0, maximum is 144. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)||||Points||Standard Deviation|Mean
1325563|NCT02178995|Other Pre-specified|Adverse Events Profile (Open-Label)|"This is a side-effects reporting scale for anti-epileptic medications. Because it encompasses cognitive and non-cognitive side effects, it was not considered one of our main cognitive/quality of life outcomes of interest. It is used in other studies of AED side effects, however, so was included.~The scale consists of 19 symptoms rated 1 (Never a problem) to 4 (Always or often a problem). Minimum score is 19, maximum score is 76. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)||||Points||Standard Deviation|Mean
1325564|NCT02178995|Secondary|CPT Outcomes (Secondary Variables) (Open-label Portion)|"Omissions, commissions, and hits~Hits” represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions” are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions” are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Baseline (Visit 1) vs end of Open-label (week 8)|Note: one epilepsy participant's CPT data was invalid/unusable due to pressing the wrong button during the trial.|||Points||Standard Deviation|Mean
1325565|NCT02178995|Secondary|QOLIE-89 Selected Cognitive Subscales (Open-label)|"Pre-selected secondary variables were cognitive subscales on the QOLIE-89 felt likely to be affected by MPH: attention/concentration; memory; language; energy/fatigue.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Comparing baseline (visit 1) to end of open-label (end of week 8)||||Points||Standard Deviation|Mean
1325566|NCT02178995|Secondary|Seizure Frequency/Severity (Double-blind Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Seizure rate during 28 days prior to study compared to during randomized, single-dose portion, rate adjusted to seizures per 28 patient days.|Only participants who were present in both groups are included here.|||Seizures per 28 at-risk days||Standard Deviation|Mean
1325567|NCT02178995|Secondary|CPT Scores (Double-blind Portion) (Secondary Variables)|"Secondary variables in CPT: hits, omissions, commissions~Hits” represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions” are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions” are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Difference between scores on MPH 20mg, 10mg, or placebo during randomized visits weeks 2, 3, or 4||||Units||Standard Deviation|Mean
1325568|NCT02178995|Primary|QOLIE-89 Aggregate Score|"QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects. The aggregate score is the overall calculated score. Note: most of its questions are specific to patients with epilepsy, and therefore the questionnaire cannot be validly completed by healthy controls. Therefore, only participants with epilepsy completed the questionnaire.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Change from baseline to end of methylphenidate open label treatment (end month 2)||||Points||Standard Deviation|Mean
1325569|NCT02178995|Primary|Seizure Frequency (Open-label Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Randomized portion is followed by 1-month open-label portion.|This analysis only compares the 28 participants who were present in both groups. Participants who participated only in the double-blind portion are represented in that analysis.|||Seizures per 28 at-risk days||Standard Deviation|Mean
1325570|NCT02178995|Primary|MCG (Open-label Portion)|MCG paragraph memory test is a measure verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.||||Points||Standard Deviation|Mean
1325571|NCT02178995|Primary|Symbol-digit Matching Test (Open Label Phase)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.||||points||Standard Deviation|Mean
1353415|NCT01753557|Secondary|Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration||36 weeks||||percentage of subjects achieving SVR12||95% Confidence Interval|Number
1325572|NCT02178995|Primary|Conners CPT Outcomes (Primary Variables) (Open-Label Portion)|"Within-groups comparison (between visit 1 and visit 5 within patients with epilepsy, comparing scores at baseline to scores on methylphenidate) as well as a comparison against healthy controls who repeated the cognitive measures an equal number of times (to assess and control for test/retest and placebo improvements).~D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|Difference between scores at baseline (visit 1) and on methylphenidate open-label (visit 5), compared to untreated healthy controls|PLEASE NOTE: One participant with epilepsy did not record any usable data for Conners CPT due to pressing the wrong key throughout large portions of the trial. Therefore, he is not included in CPT variables (but is included in other analyses).|||Units||Standard Deviation|Mean
1325573|NCT02178995|Primary|MCG Paragraph Memory Test (Double-blind Portion)|MCG paragraph memory test is a measure of verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo, randomized to be given at weeks 2, 3, or 4||||Points||Standard Deviation|Mean
1325574|NCT02178995|Primary|Symbol-digit Matching Test (Double-blind Portion)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo during double-blind portion during which medication was randomized to weeks 2, 3, or 4.||||points||Standard Deviation|Mean
1325575|NCT02178995|Primary|Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables)|"Scores on this test measure attentiveness/vigilance and response time. Primary measures are: D', HRTSD D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|difference in scores on specific variables between MPH 20mg, 10mg, and placebo (randomized to administration at weeks 2, 3, or 4)||||Units||Standard Deviation|Mean
1325576|NCT02178800|Secondary|Proportion of Injectable Hormonal-contraception-using Female Participants Who Reach a Safety or Tolerability Endpoint as Defined Above||Measured through Week 81 for Cohort 1 and Week 85 for Cohort 2|||||||
1325577|NCT02178800|Secondary|Number of Incident HIV Infections Through the Study Period, Including Number With Treatment Emergent Resistance||Measured through Week 81 for Cohort 1 and Week 85 for Cohort 2|||||||
1325578|NCT02178800|Secondary|Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners, Episodes of Unprotected Anal and/or Vaginal Intercourse) During the Study Period Using a Standardized Assessment Tool (in Aggregate Only)||Measured through Week 81 for Cohort 1 and Week 85 for Cohort 2|||||||
1325579|NCT02178800|Secondary|Proportion of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future||Measured through Week 81 for Cohort 1 and Week 85 for Cohort 2|||||||
1325580|NCT02178800|Secondary|Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)|Stratified by age, gender, race, ethnicity, weight, body mass index (BMI), and smoking status (by cohort only)|Measured through Week 81 for Cohort 1 and Week 85 for Cohort 2|||||||
1325581|NCT02178800|Secondary|Proportion of Participants Experiencing Grade 2 or Higher Clinical AEs and Laboratory Abnormalities (Safety) and Any AE That Leads to Discontinuation (Tolerability) in the Oral Phase and Washout Period||Measured through Week 5|||||||
1325582|NCT02178800|Secondary|Proportion of Participants Experiencing Grade 2 or Higher Clinical AEs and Laboratory Abnormalities During 52 Weeks Following Final Injection (Safety) and Any AE That Leads to Discontinuation (Tolerability) During the Aggregate Oral and Injectable Phases||Measured through Week 81 for Cohort 1 and Week 85 for Cohort 2|||||||
1325583|NCT02178800|Secondary|Proportion of Participants Who Discontinue Either Oral or Injectable Study Product for Reasons of Toxicity, Tolerability, or Acceptability Prior to Completion of the Full Oral and Injectable Phases||Measured through Week 81 for Cohort 1 and Week 85 for Cohort 2|||||||
1325584|NCT02178800|Primary|Proportion of Participants Who Receive at Least 1 Injection and Who Discontinue Receiving Injections Prior to the Full Course of Injections|Due to intolerability of injection (including but not limited to injection site reaction [ISR]), frequency of injections, burden of study procedures, or any AE|Measured through Week 85|||||||
1325585|NCT02178800|Primary|Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)||Measured through Week 41|This includes participants who receive at least one injection in the study.|||Participants|||Count of Participants
1325586|NCT02178787|Secondary|To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox).|CO2 reactivity will be measured as the slope of regression between UT_BF or UT_Ox and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.|one year|The data analysis has determined that UT_BF and UT_OX signals were not reliable and required further algorithm modification and development during post processing (e.g. raw data signal to noise, signal averaging) that are beyond the scope of the study. Therefore, the results were inconsistent and inconclusive. No results to report.||||||
1325588|NCT02178696|Secondary|Montgomery-Asberg Depression Rating Scale|"Designed in 1979 by researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale. MADRS was used to assess symptoms during the open label antidepressant treatment phase, so results are described as mean scores at each bi-weekly visit.~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 where 0 is no depression and 60 is most extreme depression.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts~Usual cutoff points are:~0 to 6 – normal[5] /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Screening, week 0, week 2, week 4, week 8 and week 10||||Units on a scale||Standard Deviation|Mean
1325589|NCT02178696|Secondary|Hamilton Depression Rating Scale Scores|"The total score is obtained by summing the score of each item, 0–4 (symptom is absent, mild, moderate, or severe) or 0–2 (absent, slight or trivial, clearly present). For the 17-item version, scores can range from 0 to 54, with 0 meaning no depression, and 54, severe depression.~The Hamilton Depression Rating Scale was used to assess symptoms during the open label antidepressant treatment phase, so results are described as mean scores at each bi-weekly visit."|Screening, week 0, week 2, week 4, week 8 and week 10||||Units on a scale||Standard Deviation|Mean
1325590|NCT02178696|Secondary|Changes From Baseline in PHQ-9 Depression Scores.|"The Patient Health Questionnaire-9, is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression, based on participant answers. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression, respectively. The minimum possible score is 0 and the maximum possible score is 27.~The PHQ-9 and QIDS were used to assess changes in mood during the placebo intervention (first 2 weeks), and therefore results are described as changes from the inactive to the active condition."|From Pre to post- active placebo, and from pre to post- inactive placebo (1 week intervention)|"Changes in PHQ-9 score from the beginning of the active/inactive placebo and the end of active/inactive PET scan.~Approximately 1-2 weeks between the two conditions."|||Units on a scale||Standard Deviation|Mean
1325591|NCT02178696|Secondary|Changes From Baseline in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) Score|"This scale is a self-report measure of depression with 16 items.~Questions in the QIDS – SR-116 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16).~Severity of depression can be judged based on the total score: 1-5= No depression; 6-10= Mild depression; 11-15= Moderate depression; 16-20= Severe depression; 21-27= Very severe depression.~The PHQ-9 and QIDS were used to assess changes in mood during the placebo intervention (first 2 weeks), and therefore results are described as changes from the inactive to the active condition."|From Pre to post- active placebo, and from pre to post- inactive placebo (1 week intervention)|"Changes in QIDS-16SR from screening active/inactive placebo condition to the post scan active/inactive placebo condition.~Approximately 1-2 weeks between the two conditions."|||Units on a scale||Standard Error|Mean
1325592|NCT02178696|Secondary|Changes in Dopamine (D 2/3) Binding Potential During PET.|"Binding Potential= Bmax/Kd (receptor concentration/affinity). This is the most common measure of in vivo receptor binding with PET.~Striatal changes in D2/3 receptor binding potential during PET from the Inactive to the Active condition.~Positive numbers presented here represented reductions in binding potential from the inactive to the active condition."|(90 minute PET scan) assessed at Weeks 1 and 2|Data was only collected in 26 subjects as proposed.|||Binding potential ratio||Standard Deviation|Mean
1325593|NCT02178696|Primary|Changes in BOLD Response During Reward fMRI Task (Monetary Incentive Delay, MID)|% BOLD signal changes in the nucleus accumbens from the Inactive to the Active Placebo condition.|(90 minute fMRI scans) assessed at Weeks 1 and 2|Data was missing in 11 subjects due to movement artifacts, or incidental findings that made the data not usable.|||% BOLD changes from Inactive to Active||Standard Deviation|Mean
1325594|NCT02178696|Primary|Changes in Mu-opioid Binding Potential During PET|"Binding Potential = Bmax/Kd (receptor concentration/affinity). This is the most common measure of in vivo receptor binding with positron emission tomography. Whole brain changes in mu-opioid receptors binding potential during PET from the Inactive to the Active placebo condition.~Positive numbers presented here represent reductions in binding potential from the inactive to the active condition."|(90 minute PET scans) assessed at Weeks 1 and 2|Data in four subjects was missing due to failure in the synthesis of the radio tracer for at least one of the two scans.|||Binding potential ratio||Standard Deviation|Mean
1325595|NCT02178540|Primary|The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device|Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU.|1 Day|The Full Analysis Set (FAS) included all enrolled patients who completed an HF assessment as defined by completion of inhalation of the contents of at least one capsule and related HF assessment.|||Patients failing to understand IFU|||Number
1325596|NCT02178475|Secondary|Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis|On-schedule pegfilgrastim primary prophylaxis was defined as participants who received pegfilgrastim in cycle 1 and continued to receive pegfilgrastim across all cycles, administered 1-3 days after the end of cytotoxic chemotherapy in each cycle.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received pegfilgrastim across all cycles, administered 1- 3 days after the end of cytotoxic chemotherapy in each cycle.|||participants|||Number
1327226|NCT02145468|Secondary|Number of Participants With All-cause Mortality Through to Week 12 and Week 24|Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1325599|NCT02178475|Secondary|Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred|The number of chemotherapy cycles during which an event of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Cycles of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||cycles|cycles||Number
1325600|NCT02178475|Secondary|Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis|The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced complications of febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered|||participants|||Number
1325601|NCT02178475|Secondary|Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis|The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||participants|||Number
1325602|NCT02178475|Secondary|Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis|The number of febrile neutropenia events that occurred during a cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|All FN events observed for participants in the primary analysis set|||febrile neutropenia events|febrile neutropenia events||Number
1325603|NCT02178475|Secondary|Percentage of Participants Who Experienced Complications of Febrile Neutropenia|Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|primary analysis set|||percentage of participants||95% Confidence Interval|Number
1325604|NCT02178475|Secondary|Reasons for Discontinuation of G-CSF Prophylaxis|"Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.~Data includes both temporary and permanent discontinuation of G-CSF prophylaxis. Participants may have more than 1 discontinuation reason."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||participants|||Number
1325605|NCT02178475|Secondary|Reasons for Discontinuation of Pegfilgrastim Prophylaxis|"Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.~Data includes both temporary and permanent pegfilgrastim discontinuation."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.|||Participants|||Count of Participants
1325606|NCT02178475|Secondary|Number of Cycles With no G-CSF Prophylaxis|A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|All cycles of chemotherapy for participants in the primary analysis set|||cycles|cycles||Number
1325607|NCT02178475|Secondary|Number of Cycles With No Pegfilgrastim Prophylaxis|A cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|All cycles of chemotherapy for participants in the primary analysis set|||cycles|cycles||Number
1325608|NCT02178475|Secondary|Characteristics of Participants Who Discontinued G-CSF Prophylaxis|"Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.~Data includes both temporary and permanent discontinuation of G-CSF prophylaxis."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||participants|||Number
1325609|NCT02178475|Secondary|Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis|"Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.~Data includes both temporary and permanent pegfilgrastim discontinuation."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.|||participants|||Number
1325822|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|3-8 years||2024-06-30|06/2024||||
1325610|NCT02178475|Secondary|Number of Participants Who Discontinued G-CSF Prophylaxis|"Participants who discontinued G-CSF prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.~Discontinuation was categorized as either temporary (participant received G-CSF prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no G-CSF prophylaxis was administered, and no G-CSF prophylaxis was administered in any subsequent cycle, OR participant did not receive G-CSF prophylaxis in the last cycle of chemotherapy)."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||participants|||Number
1325611|NCT02178475|Secondary|Number of Participants Who Discontinued Pegfilgrastim Prophylaxis|"Participants who discontinued pegfilgrastim prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.~Discontinuation was categorized as either temporary (participant received pegfilgrastim prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no pegfilgrastim prophylaxis was administered, and other G-CSF prophylaxis (i.e. not pegfilgrastim) was administered in all subsequent cycles, OR participant did not receive pegfilgrastim prophylaxis in the last cycle of chemotherapy, and other G-CSF prophylaxis was administered)."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||participants|||Number
1325612|NCT02178475|Primary|Percentage of Participants With Febrile Neutropenia|Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1325613|NCT02178059|Primary|Maximum Observed Plasma Concentration (Cmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.|||nmol/L||95% Confidence Interval|Geometric Mean
1325614|NCT02178059|Secondary|Terminal Half-life (t1/2)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||hour||Geometric Coefficient of Variation|Geometric Mean
1325615|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1325616|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||nmol*h/L||95% Confidence Interval|Geometric Mean
1325617|NCT02178059|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||hour||95% Confidence Interval|Median
1325618|NCT02178059|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.|||nmol*h/L||95% Confidence Interval|Geometric Mean
1325619|NCT02177266|Other Pre-specified|Number of Participants With Serious and Non-Serious Adverse Events||Baseline - 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.||||||
1325620|NCT02177266|Secondary|Trans-thoracic Echocardiography for Constriction||Baseline to 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.||||||
1325621|NCT02177266|Primary|Number of Patients With Post Cardiac Surgery Atrial Fibrillation or Post-pericardiotomy Syndrome.||Baseline to 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.||||||
1325622|NCT02177201|Primary|Postoperative Vomiting|Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition|First 24 hours postoperative||||participants|||Number
1325623|NCT02177136|Secondary|Change From Baseline in Plasma C4||Baseline and 24 weeks|Intent-To-Treat Population|||ng/mL||Inter-Quartile Range|Median
1325624|NCT02177136|Secondary|Change From Baseline in Plasma Fibroblast Growth Factor-19 (FGF-19)||Baseline and 24 weeks|Intent-to-Treat Population|||pg/mL||Inter-Quartile Range|Median
1325625|NCT02177136|Secondary|Change From Baseline in Serum Gamma-Glutamyl Transferase (GGT)||Baseline and 24 weeks|Intent-To-Treat Population|||U/L||Inter-Quartile Range|Median
1325626|NCT02177136|Secondary|Change From Baseline in Serum Direct Bilirubin||Baseline and 24 weeks|Intent-To-Treat Population|||umol/L||Inter-Quartile Range|Median
1325627|NCT02177136|Secondary|Change From Baseline in Serum Total Bilirubin||Baseline and 24 weeks|Intent-To-Treat Population|||umol/L||Inter-Quartile Range|Median
1325628|NCT02177136|Secondary|Change From Baseline in Serum Aspartate Aminotransferase (AST)||Baseline and 24 weeks|Intent-to-Treat Population|||U/L||Inter-Quartile Range|Median
1325629|NCT02177136|Secondary|Change From Baseline in Serum Alanine Transaminase (ALT)||Baseline and 24 weeks|Intent-To-Treat Population|||U/L||Inter-Quartile Range|Median
1325631|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age|Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age|At Days 8, 15,50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites, TRC with HRIG Groups|||Percentages of Subjects||95% Confidence Interval|Number
1325632|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age|Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites TRC with HRIG Groups.|||IU/mL||95% Confidence Interval|Geometric Mean
1325633|NCT02177032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Day 1 to Day 366|Unsolicited Safety Set- All subjects in the Exposed Population who have post vaccination unsolicited adverse event records. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.|||Subjects|||Number
1325634|NCT02177032|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)|Solicited Safety Set- All subjects in the Exposed Population who provide post vaccination solicited adverse event data. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.|||Subjects|||Number
1325635|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age|Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is only applicable for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.|||Percentages of Subjects||95% Confidence Interval|Number
1325636|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age|Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.|||IU/mL||95% Confidence Interval|Geometric Mean
1325637|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age|"Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.~Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)"|At Days 8, 15,50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.|||Percentages of Subjects||95% Confidence Interval|Number
1325638|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age|"Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.~RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)"|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.|||IU/mL||95% Confidence Interval|Geometric Mean
1325639|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age|"Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.~RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population."|At Days 8, 15, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.|||Percentages of Subjects||95% Confidence Interval|Number
1325648|NCT02176655|Secondary|Satisfaction|To assess subject satisfaction with treatment results comparing VVD-101 vs. placebo. Satisfaction was measured on a 7 point Likert scale whereas 0 = extremely dissatisfied and 6 = extremely satisfied.|24 Hours Post Treatment for 3 Headaches (estimated 6 months)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
1325640|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age|"Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.~Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population."|At Days 8, 15, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.|||IU/mL||95% Confidence Interval|Geometric Mean
1325641|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs|"Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.~Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population."|Study Day 50|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis|||IU/mL||95% Confidence Interval|Geometric Mean
1325642|NCT02177032|Primary|"Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences (4-sites, 1-week to That of 2-sites, TRC ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)"|"Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.~Non-inferiority of the immune response of the new 4-sites, 1-week ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended 2-sites, TRC ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population."|Study day 50 (D50)|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.|||Percentages of Subjects||95% Confidence Interval|Number
1325643|NCT02176837|Primary|Cerebral Vasospasm|Cerebral digital subtraction angiographies will be reviewed at at least 2 time points, including at the time of diagnosis of angiographic vasospasm immediately before treatment with nitrite and after up to 180 minutes of nitrite infusion. Radiographs will be compared to determine whether increased flow of radiographic dye is visualized following initiation of nitrite infusion.|180 minutes|Patients who received sodium nitrite|||Participants|||Count of Participants
1325644|NCT02176655|Other Pre-specified|Meaningful Headache Relief|Time to meaningful headache relief for VVD-101 vs. placebo. Meaningful headache relief is defined as experiencing substantial relief as reported by the subject.|Time of Onset to Meaningful Headache Relief (up to 24 hours)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||minutes||Standard Deviation|Mean
1325645|NCT02176655|Other Pre-specified|Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment|Comparison of headache severity 2 hours post treatment of headache treated with VVD-101 with each associated hangover symptom items on the AHS taken before treatment. Individual Hangover Symptoms Scores range from 0 [None] to 7 [Incapacitating]. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms.Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Before Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
1325646|NCT02176655|Other Pre-specified|Number of Drinks Consumed Compared to Pain Severity 2 Hours Post Treatment|Comparison of the number of drinks consumed at one sitting with pain severity 2 hours post treatment for headaches treated with VVD-101. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Time of Last Sitting to 2 Hours Post Treatment (estimated 14 hours)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||Number of Drinks Consumed||Standard Deviation|Mean
1325647|NCT02176655|Secondary|Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment|Comparison of Acute Hangover Scale (AHS) score before treatment with headache pain severity 2 hours post treatment for headaches treated with VVD-101. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Before Treatment of 3 Headaches to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
1325823|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-7 years||2024-06-30|06/2024||||
1325824|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-6 years||2023-12-31|12/2023||||
1325649|NCT02176655|Secondary|Number of Participants With Consistent Response to VVD-101|To assess the consistency of response to VVD-101 over the three active treatments of VVD-101. Consistency is defined as meeting the requirements of headache relief 2 hours post treatment for 2 out of 3 active treated headaches. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Response to Treatment of Three Headaches (estimated 6 months)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||participants|||Number
1325650|NCT02176655|Secondary|Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment|Number of headaches with sustained headache pain freedom at 24 hours post treatment for VVD-101 vs. placebo. Sustained headache pain freedom is defined as no pain 2 hours post treatment and headache freedom continuing for 24 hours post treatment without rescue. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Time of Treatment to 24 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 28 headaches were analyzed for this endpoint.|||Headaches|Headaches||Number
1325651|NCT02176655|Secondary|Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment|Number of headaches relieved (no head pain) at 2 hours post treatment for VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.|||Headaches|Headaches||Number
1325652|NCT02176655|Secondary|Number of Headaches Relieved|Headache relief from before treatment, at 30 minutes, 1 hour, and 2 hours post treatment in attacks treated with VVD-101 vs. placebo. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.|||Headaches|Headaches||Number
1325653|NCT02176655|Secondary|Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment|Change in headache severity from before treatment, at 30 minutes, and 1 hour post treatment in attacks treated with VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment through 1 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
1325654|NCT02176655|Primary|Headache Severity 2 Hours Post Treatment|Headache severity 2 hours post treatment in sumatriptan succinate 12.5 mg and acetylsalicylic acid 325 mg (VVD-101) vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment through 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
1325655|NCT02176642|Other Pre-specified|Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain|To compare bother from medication side effects between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). The questionnaire was completed at baseline and at 6 weeks. The TSQMvII side effects domain at each time point was transformed into a score from 0 (extremely dissatisfied) to 150 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.|Baseline, 6 weeks|Two patients in the placebo+PTN group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1325656|NCT02176642|Other Pre-specified|Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain|To compare treatment satisfaction between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). Patients completed the questionnaire at baseline and again at 6 weeks. The TSQMvII satisfaction domains at each timepjoint were transformed into a score from 0 (extremely dissatisfied) to 100 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.|Baseline, 6 weeks|Two patients in the placebo+PTN group and 1 patient in the oxybutynin+PTNS group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1325657|NCT02176642|Other Pre-specified|Change in the Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is a 7-question score assessing how urinary incontinence affects a patient's various activities and feelings. The range of possible scores is from 0 (not at all) to 28 (a great deal). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|1 patient in the oxybutynin+PTNS group did not complete the 6 week IIQ-7 questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1325658|NCT02176642|Other Pre-specified|Change in the Urinary Distress Inventory (UDI-6)|The UDI-6 is a 6-question inventory of how frequently and how much bother patients have from overactive bladder symptoms. The scores range from 0 (not at all) to 24 (a great deal of bother). We compared the change in scores from baseline to 6 weeks between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|1 patient in the oxybutynin+PTNS group did not complete the 6 week UDI-6 questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1325659|NCT02176642|Other Pre-specified|Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2|Part 2 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 13 questions, with scores ranging from 13 (least amount of bother) to 78 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 2 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|Four patients in the oxybutynin+PTNS group and 1 patient in the placebo+PTNS did not submit their OABq-SF part 2 at the end of the study, so they were unable to be included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1325660|NCT02176642|Other Pre-specified|Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1|Part 1 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 6 questions, with scores ranging from 6 (least amount of bother) to 36 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 1 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|3 patients in the oxybutynin+PTNS group did not submit their OABq-SF at the end of the study, so they were unable to be included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1325661|NCT02176642|Other Pre-specified|Change in the Patient Global Impression of Improvement (PGI-I)|The Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better to) 7 (Very much worse).|Baseline, 6 weeks|2 patients in the oxybutynin+PTNS group and one patient in the placebo+PTNS group did not complete the 6 week PGI-I questionnaire so they were not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1325662|NCT02176642|Secondary|Change in 24hr Pad Weight|To compare the change, from baseline, in 24h pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo. Change in median 24h pad weight from baseline to 6 weeks was compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|Six participants in the placebo+PNTS group and 3 patients in the oxybutynin+PTNS group did not provide a pad weight at the end of the study, and thus were unable to have the pad weight change score calculated.|||grams||Inter-Quartile Range|Median
1325663|NCT02176642|Primary|Change in Median Number of UUI Episodes Per Day|To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated [post-treatment UUI/day minus pre-treatment UUI/day].|Baseline, 6 weeks|3 patients in each group did not provide bladder diaries at their 6 week visit, so did not have information available to calculate the primary outcome measure. Median change in UUI episodes/day from baseline to 6 weeks was compared between 2 groups using Wilcoxon Rank Sum test.|||Urge urinary incontinence episodes/day||Inter-Quartile Range|Median
1325664|NCT02176525|Secondary|Body Temperature|The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint.|Visit 1, Visit 7|Treated set.|||degree (°C)||Standard Deviation|Mean
1325665|NCT02176525|Secondary|Assessment of Global Tolerability on a 4-point Scale|The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator.|day 6|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
1325666|NCT02176525|Secondary|Number of Patients With Abnormal Findings in Physical Examination|The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study.|up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
1325667|NCT02176525|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse event (AE)|up to 14 days|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
1325668|NCT02176525|Secondary|Number of Patients With Abnormal Changes in Laboratory Tests|Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events.|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
1325669|NCT02176525|Secondary|Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)|Number of patients with a new onset of an abnormal finding by central assessment are presented.|up to 14 days|Treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation. Only patients included having no missing ECG measurements .|||participants|||Number
1325670|NCT02176525|Secondary|Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).|Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
1325691|NCT02176421|Secondary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
1325671|NCT02176525|Secondary|Plasma Concentration Time Profiles|Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated.|up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325672|NCT02176525|Secondary|Vz/F,ss|"Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||Litre (L)||Geometric Coefficient of Variation|Geometric Mean
1325673|NCT02176525|Secondary|CL/F,ss|"Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||Millilitre per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1325674|NCT02176525|Secondary|t1/2,ss|"Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||h||Full Range|Median
1325675|NCT02176525|Secondary|λz,ss|"Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||1/h||Full Range|Median
1325676|NCT02176525|Secondary|AUC0-∞,ss|"Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1325677|NCT02176525|Secondary|AUCτ,ss|"Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1325678|NCT02176525|Secondary|Tmax,ss|Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||h||Full Range|Median
1325679|NCT02176525|Secondary|Cmin,ss|"The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss).~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325680|NCT02176525|Secondary|Cmax,ss|"The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss).~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)"|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325681|NCT02176525|Secondary|AUC0-τ|Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS|||Nanogram*hours/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1325682|NCT02176525|Secondary|Tmax|Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS|||hours (h)||Full Range|Median
1325683|NCT02176525|Secondary|Cmin|Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325684|NCT02176525|Secondary|Cmax|Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|The PK set (PKS) included all patients in the full analysis set (FAS) with evaluable PK data. FAS included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1325685|NCT02176525|Secondary|Time Dependent Change From Baseline in Viral Load (VL)|Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint.|Baseline, up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||log10 (U/L)||Standard Deviation|Mean
1325686|NCT02176525|Primary|Virologic Response (VR)|Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented.|Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1325687|NCT02176421|Secondary|Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)|Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject’s overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse).|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
1325688|NCT02176421|Secondary|Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
1325689|NCT02176421|Secondary|Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
1325690|NCT02176421|Secondary|Injector Ease of Use on an 11-Point Scale|The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy).|Day 0|All subjects with data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
1325735|NCT02175368|Secondary|Clinical Quality|The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points.|1 week, 1 year, 2 years, 3 years|||||||
1325692|NCT02176421|Primary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Month 1|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
1325693|NCT02176356|Secondary|Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area|Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ). Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325694|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant's Perioral Lines Severity|The investigator assessed the participant’s perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) [best], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)[worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325695|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Oral Commissures Severity|The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325696|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Nasolabial Folds Severity|The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) [best], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle). A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325697|NCT02176356|Secondary|Change From Baseline in the Investigator’s Assessment of the Participant’s Overall Mid-Face Volume Deficit Using the 6-Point MFVDS|The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) [best], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325698|NCT02176356|Secondary|Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)|The investigator assessed the participant’s eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325699|NCT02176356|Secondary|Change From Baseline in Investigator’s Assessment of the Severity of Crow’s Feet Lines (CFLs) at Maximum Smile Using the FWS|The investigator assessed the severity of the participant’s CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325700|NCT02176356|Secondary|Change From Baseline in Investigator’s Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)|The investigator assessed the severity of the participant’s GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1325701|NCT02176356|Secondary|Participant's Self- Perception of Age (SPA)|Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today? Participants recorded how many years younger or older they thought their facial appearance made them look. A negative result indicates improvement (a younger appearance).|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||years||Standard Deviation|Mean
1325702|NCT02176356|Secondary|Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire|Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
1325736|NCT02175368|Primary|Number of Participants With Clinical Success|Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.|1 week||||Participants|||Count of Participants
1325825|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-5 years||2022-12-31|12/2022||||
1325703|NCT02176356|Secondary|Change From Baseline in Social Confidence Using an 8-item Questionnaire|Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
1325704|NCT02176356|Secondary|Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)|Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||years||Standard Deviation|Mean
1325705|NCT02176356|Secondary|Change From Baseline in Aging Appearance Using a 7-item Questionnaire|Participants rated how they look now using a 7-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
1325706|NCT02176356|Primary|Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire|Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Modified Intent-to-Treat (mITT) population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
1325707|NCT02176343|Primary|Mean IOL Rotation|Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||degrees||Standard Deviation|Mean
1325708|NCT02176343|Primary|Mean Best Corrected Distance Visual Acuity (BCDVA)|VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
1325709|NCT02176343|Primary|Mean Uncorrected Intermediate Visual Acuity|VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
1325710|NCT02176343|Primary|Mean Uncorrected Near Visual Acuity|VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
1325711|NCT02176343|Primary|Mean Uncorrected Distance Visual Acuity|Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
1325712|NCT02176343|Primary|Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D|Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism > 1.00 D.|||percentage of subjects|||Number
1325713|NCT02176343|Primary|Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D|Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||percentage of subjects|||Number
1325737|NCT02175212|Secondary|Late Toxicity|"Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.~Scoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer–Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.~CV events were defined according to the World Health Organization criteria"|5 years||||percentage of patients|||Number
1325714|NCT02176343|Primary|Mean Percent Reduction in Cylinder|Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||percent change||Standard Deviation|Mean
1325715|NCT02176291|Secondary|Brief Symptom Inventory--Anxiety Subscale (BSI)|"Measure of Anxiety Theoretical Range 0-2.4 with lower numbers indicating a better outcome.~We calculated the mean change in anxiety for both groups using Phase 1 week 12 time point (baseline) and Phase 2 week 8 time point (final time point)."|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1325716|NCT02176291|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"Measure of depression severity, range of 0-60~We calculated the mean change in depression severity for both groups using baseline MADRS and week 8 MADRS scores.~Greater mean change represents better outcome."|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1325717|NCT02176018|Secondary|Adverse Events|Compare the number of adverse events in the Nuedexta arm vs. the placebo arm.|Baseline (Day 0) to Treatment Period Month 3 (Day 116)||||Number of Adverse Events|||Number
1325718|NCT02176018|Secondary|Headache Health Score|Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life.|Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.|||units on a scale||Standard Deviation|Mean
1325719|NCT02176018|Secondary|Migraine Disability Assessment Scale (MIDAS)|"MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) how many days in the last 3 months... questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following:~0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability"|Visit 2 (Day 28) to Visit 5 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.|||units on a scale||Standard Deviation|Mean
1325720|NCT02176018|Secondary|Acute Medication Use in Each Treatment Period Month|The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.|||Number of medication doses||Standard Deviation|Mean
1325721|NCT02176018|Secondary|50% Headache Reduction|The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm.|Baseline (Day 0) to Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Participants|||Count of Participants
1325722|NCT02176018|Secondary|Headache Duration in Each Treatment Period Month|The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours.|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.|||Hours||Standard Deviation|Mean
1325723|NCT02176018|Secondary|Headache Severity in Each Treatment Period Month|The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain.|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.|||units on a scale||Standard Deviation|Mean
1325724|NCT02176018|Secondary|Migraine Days in Each Treatment Period Month|The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Number of Migraine days||Standard Deviation|Mean
1325725|NCT02176018|Secondary|Headache Days in Treatment Period Month 3|The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.|End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Number of headache days||Standard Deviation|Mean
1325726|NCT02176018|Primary|Headache Days in Each Treatment Period Month|The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.|Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Number of Headache days||Standard Deviation|Mean
1325727|NCT02175771|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period|"Spirometry measurements were obtained before the AM dose of study drug for the randomization visit (Day 1), at each of the treatment visits and at the early termination visit if applicable. At each visit where FEV1 was assessed, the highest acceptable results from each session were recorded.~The analysis is based on a mixed model for repeated measures (MMRM) with adjustment for baseline FEV1, sex, age, (pooled) investigational center, visit, treatment, and treatment-by-visit. An unstructured covariance matrix is used in the MMRM model."|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicable|The full analysis set (FAS) included all participants in the intent-to-treat (ITT) population who received at least 1 dose of study drug and had at least 1 post-baseline trough FEV1 assessment.|||liters||Standard Error|Least Squares Mean
1325728|NCT02175771|Secondary|Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period|"Samples for 24-hour urine cortisol were collected at baseline (Day 1, pretreatment), and Weeks 14 and 26. For participants requiring early termination (ET), this evaluation was performed at the ET visit. For participants requiring ET for safety reasons, the visit was not delayed in order to collect the 24-hour urine cortisol.~The analysis is based on a mixed model for repeated measures (MMRM) model with adjustment for visit, treatment, and a treatment*visit interaction. The urine cortisol result is log transformed prior to analysis and the results are back transformed after modeling. An unstructured covariance matrix is used in the MMRM model."|Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicable|A urine cortisol analysis subset of the safety population was defined that included participants whose urine samples did not have confounding factors at any visit that could affect the interpretation of the results.|||mcg/24 hours||95% Confidence Interval|Geometric Mean
1325729|NCT02175771|Secondary|Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings|A 12 lead ECG was conducted at the screening visit and week 26 or the early termination visit. A qualified physician at a central diagnostic center was responsible for interpreting the ECG. The worst post-baseline finding for the participant is summarized. Endpoint refers to the last observation carried forward.|Screening (Day -14), Endpoint (week 26 if study was completed)|Safety population of participants with both screening and endpoint ECGs|||Participants|||Count of Participants
1325730|NCT02175771|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values during the Treatment period.~Significance criteria:~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute"|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint|Safety population of participants with a baseline and postbaseline vital sign value.|||Participants|||Count of Participants
1325731|NCT02175771|Secondary|Participants With Positive Swab Test Results for Oral Candidiasis|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit by a qualified healthcare professional. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.~This outcomes indicates how many participants had positive swab test results. The total number of participants who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Participants with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol."|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint|Safety population|||Participants|||Count of Participants
1325732|NCT02175771|Primary|Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 26 of the Treatment Period|"Safety population which included all randomized participants who received at least 1 dose of randomized study drug.~The randomization allocation ratio of 3:1 (study drug: active comparator) should be taken into account when comparing treatment groups within treatment/strength cohorts"|||Participants|||Count of Participants
1325733|NCT02175745|Primary|Percent Agreement of 18F FDOPA PET With Pathology|For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.|Up to 30 minutes post-injection (at time of scan)||||percentage of agreement (sensitivity)|||Number
1325734|NCT02175745|Primary|Number of Suspicious Lesions Identified by 18F FDOPA PET|The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.|Up to 30 minutes after injection of F18 FDOPA||||suspicious lesion(s)|||Number
1325740|NCT02175212|Secondary|Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years|Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).|5 years||||percentage of participants||95% Confidence Interval|Number
1325741|NCT02175212|Primary|Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years|Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).|5 years||||percentage of patients||95% Confidence Interval|Number
1325742|NCT02175199|Secondary|Lens Comfort 1-10 Scale Response|"Subject was instructed, Please rate your comfort with the study lenses, using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together."|Day 30|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||units on a scale||Standard Deviation|Mean
1325743|NCT02175199|Secondary|Lens Comfort Likert Response at Day 14|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only."|Day 14|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||percentage of subjects|||Number
1325744|NCT02175199|Primary|Lens Comfort Likert Response at Day 30|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only."|Day 30|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||percentage of subjects|||Number
1325745|NCT02175121|Secondary|Apparent Clearance (CL/F)|Apparent oral clearance of PF-06291874.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1325746|NCT02175121|Secondary|Minimum Plasma Concentration (Cmin)|Minimum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325747|NCT02175121|Secondary|Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours)|Area under the PF-06291874 plasma concentration-time profile from time zero to time tau, the dosing interval, where tau=24 hours.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1325748|NCT02175121|Secondary|Time to Reach Cmax (Tmax)|Time to maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||hour (hr)||Full Range|Median
1325749|NCT02175121|Secondary|Maximum Plasma Concentration (Cmax)|Maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1325750|NCT02175121|Secondary|Percent Change From Baseline in Lipoprotein A|The Lipoprotein A percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325751|NCT02175121|Secondary|Percent Change From Baseline in Apolipoprotein B100|The Apolipoprotein B100 was calculated as the difference between total Apolipoprotein B and Apolipoprotein B48 and analyzed the percent change from baseline (defined as mean of Day 0 and Day 1) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325752|NCT02175121|Secondary|Percent Change From Baseline in LDL Size|The LDL size percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325826|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-4 years||2021-12-31|12/2021||||
1325753|NCT02175121|Secondary|Percent Change From Baseline in Total LDL Particles|Total LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325754|NCT02175121|Secondary|Percent Change From Baseline in Very Small LDL Particles|Very small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325755|NCT02175121|Secondary|Percent Change From Baseline in Small LDL Particles|Small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325756|NCT02175121|Secondary|Percent Change From Baseline in Medium Small LDL Particles|Medium small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325757|NCT02175121|Secondary|Percent Change From Baseline in Large LDL Particles|Large LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325758|NCT02175121|Secondary|Percent Change From Baseline in Oxidized LDL|Oxidized LDL percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325759|NCT02175121|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325760|NCT02175121|Secondary|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325761|NCT02175121|Secondary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)|LDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325762|NCT02175121|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325763|NCT02175121|Secondary|Percent Change From Baseline in Triglycerides|Triglycerides percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
1325764|NCT02175121|Secondary|Change From Baseline in Fasting Plasma Glucose|Fasting plasma glucose response change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||mg/dL||Standard Deviation|Mean
1325827|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|3-10 years||2024-06-30|06/2024||||
1325765|NCT02175121|Secondary|Change From Baseline in Mean Daily Glucose|The mean daily glucose was determined from the area under the concentration (AUC) of the glucose concentrations measured at nominal times 0, 0.5, 1, 1.5, 2, 4, 6, 10, 12, 15 and 24 hours post dose. Mean daily glucose change from baseline (defined as Day 0) on Day 28.|Baseline and Day 28|The full analysis set (FAS) was used in the analysis of the pharmacodynamic (PD) parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||mg/dL||Standard Deviation|Mean
1325766|NCT02175121|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 msec; >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 milliseconds (msec); >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1325767|NCT02175121|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern|Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1325768|NCT02175121|Primary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1325769|NCT02175121|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
1325770|NCT02174861|Secondary|CHU Substudy: Number of Participants With Adverse Events|"Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.~Injection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms.~An adverse device effect (ADE) is any adverse event related to the use of a medical device."|From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks.|All randomized participants who received at least one dose of erenumab in the CHU substudy.|||Participants|||Count of Participants
1325771|NCT02174861|Secondary|Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours|"The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.~A qualified headache was defined as follows:~a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or~a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or~a headache of any duration for which acute headache treatment was administered."|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.|||hours / month||Standard Deviation|Mean
1325772|NCT02174861|Secondary|Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days|Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.|||acute migraine treatment days / month||Standard Deviation|Mean
1325792|NCT02173704|Secondary|Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)|Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered.|At Day 305 and Day 335|Analysis was done on FAS population Day 335. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Percentage of subjects||95% Confidence Interval|Number
1353968|NCT01746264|Secondary|Total Cholesterol|Total cholesterol levels were measured by an enzymatic colorimetric assay.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
1325773|NCT02174861|Secondary|Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit.~At least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1325774|NCT02174861|Secondary|Change From Study 20120295 Baseline in Monthly Migraine Days|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the number of migraine days during the 4 weeks prior to each study visit – the number of migraine days during the 4-week baseline phase."|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The number of participants analyzed includes participants with available data at each time point.|||migraine days / month||Standard Deviation|Mean
1325775|NCT02174861|Primary|CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use|At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.|Day 29 (week 4) and day 57 (week 8) of the substudy|All randomized participants who received at least 1 dose of erenumab in the CHU substudy.|||Participants|||Count of Participants
1325776|NCT02174861|Primary|Number of Participants With Adverse Events|Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.|From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).|All enrolled participants who received at least 1 dose of erenumab|||Participants|||Count of Participants
1325777|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Handling of Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available handling of inhaler satisfaction data|||Percentage of participants|||Number
1325778|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available inhaler satisfaction data|||Percentage of participants|||Number
1325779|NCT02173769|Secondary|Patient Satisfaction: Overall Satisfaction|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available satisfaction data|||Percentage of participants|||Number
1325780|NCT02173769|Secondary|General Health of the Patient After 4-6 Weeks|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks.~The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|4-6 weeks|FAS including patients with available PGE score at end of study visit|||Percentage of participants|||Number
1325781|NCT02173769|Secondary|General Health of the Patient at Baseline|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination.~The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|Baseline|FAS including patients with available PGE score at baseline|||Percentage of participants|||Number
1325782|NCT02173769|Secondary|Absolute Changes in the PF-10 Score|"Absolute changes in the PF-10 score.~The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|4-6 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1325783|NCT02173769|Primary|"Percentage of Participants With Therapeutic Success"|"Percentage of participants with therapeutic success defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks.~The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|Baseline and 4-6 weeks|Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.|||Percentage of participants|||Number
1325819|NCT02173379|Secondary|Number of Participants With Target Lesion Failure (TLF)|The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)|1 year||2018-12-31|12/2018||||
1325820|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|3-10 years||2024-06-30|06/2024||||
1325784|NCT02173704|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.|"Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.~SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination.~Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason."|Throughout the study period (Day 1 to Day 335)|Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records.|||Number of participants|||Number
1325785|NCT02173704|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines|Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.|From day 1 to day 7 after each vaccination|Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records.|||Number of subjects|||Number
1325786|NCT02173704|Secondary|Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.|"Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age.~Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration."|From Day 1 to Day 28 after vaccination|Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.|||Number of participants|||Number
1325787|NCT02173704|Secondary|Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.|"Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months.~Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C)"|From day 1 (6 hours) to day 7 after each vaccination|Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.|||Number of participants|||Number
1325788|NCT02173704|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.|"Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months.~Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness."|From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination)|Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.|||Number of participants|||Number
1325789|NCT02173704|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines|Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines [Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines [Priorix® and Varilrix® vaccine],as compared to when only routine vaccines were administered.|At Day 1,Day 152,Day 305, Day 335|Analysis was done on FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Percentages of subjects||95% Confidence Interval|Number
1325790|NCT02173704|Secondary|hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.|GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305).|At Day 1, Day 152, Day 305 and Day 335|Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
1325791|NCT02173704|Secondary|hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines|hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered.|At Day 1, Day 152, Day 305 and Day 335|Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Titer||95% Confidence Interval|Geometric Mean
1325793|NCT02173704|Primary|Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B.|Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).|At Day 1 and at one month after the third vaccination (Day 152)|Analysis was done on Full Analysis Set (FAS) population day 152. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Percentages of subjects||95% Confidence Interval|Number
1325794|NCT02173548|Secondary|Hospital Admission for Acute Decompensated Heart Failure|Number of participants admitted to hospital for acute decompensated heart failure|24 weeks||||Participants|||Count of Participants
1325795|NCT02173548|Secondary|Change in Quality of Life Questionnaire-Duke Activity Status Index (DASI)|Two independent questionnaires will be used to assess quality of life and HF symptoms. The Duke Activity Status Index (DASI) questionnaire is a 12-question, yes/no, instrument that allows for the calculation of perceived functional capacity, in which each question describes a different physical activity and the questions are weighted according to their degree of physical exertion. Higher scores indicate greater functional capacity. The questionnaire will be administered at 0, 4, 12 and 24 weeks in accordance with cardiopulmonary test (CPET) and echocardiography. Scores range from zero to 58.2 with higher scores indicating higher functional status.|Baseline to 12 weeks||||units on DASI scale||Inter-Quartile Range|Median
1325796|NCT02173548|Secondary|Change in Quality of Life Questionnaire-Minnesota Living With Heart Failure Questionnaire (MLWHF)|The Minnesota Living with Heart Failure questionnaire (MLWHF) is a 21-question graded questionnaire that has been extensively used to measure impairment in quality of life in patients with HF, with higher scores reflecting increased burden of HF symptoms. The questionnaire will be administered in accordance with cardiopulmonary test (CPET) and echocardiography. Scores range from zero to 105 with lower scores indicating better quality of life.|Baseline to 24 weeks||||units on MWLHF scale||Inter-Quartile Range|Median
1325797|NCT02173548|Secondary|Change in Inflammation (C Reactive Protein Levels)|The change C reactive protein (CRP) levels will be reported at 12 weeks. Higher C reactive protein levels indicate greater inflammation.|Baseline to 12 weeks||||mg/l||Inter-Quartile Range|Median
1325798|NCT02173548|Secondary|Change in Diastolic and Contractile Reserve (e' Velocity and E/e' Ratio)|Exercise stress echocardiography will be performed at baseline and 12 weeks to measure diastolic and contractile reserve. We will perform an assessment before initiation of exercise and immediately after cessation of peak exercise.|Baseline to 12 weeks|Data not available for all participants.|||ratio||Inter-Quartile Range|Median
1325799|NCT02173548|Secondary|Echocardiographic Assessment of Diastolic and Systolic Function (Left Ventricular Ejection Fraction)|Structural and functional echocardiographic parameters include left and right ventricular dimensions, mass, systolic and diastolic function. (Change in e')|12 weeks||||cm/second||Inter-Quartile Range|Median
1325800|NCT02173548|Primary|Change in Ventilatory Eefficiency|Absolute changes in ventilatory efficiency (VE/VCO2 [carbon dioxide] slope) after 12 weeks treatment. This will compare patients treated with anakinra vs placebo, and provide a randomized, double-blinded assessment of the effects of IL-1β blockade on aerobic exercise performance.|Baseline to 12 weeks||||VE/VO2 slope||Inter-Quartile Range|Median
1325801|NCT02173548|Primary|Change in Aerobic Exercise Capacity|Absolute changes in aerobic exercise capacity (peak VO2) after 12 weeks treatment. This will compare patients treated with anakinra and provide a randomized, double-blinded assessment of the effects of IL-1β blockade on aerobic exercise performance.|Baseline to 12 weeks||||ml/kg/min||Inter-Quartile Range|Median
1325802|NCT02173535|Primary|Number of Subject in Agreement (Enhance Eyes)|"Subjects' responses to the question Enhance my overall appearance were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints|||Participants|||Number
1325803|NCT02173535|Primary|Number of Subject in Agreement (Defines Eyes)|"Subjects' responses to the question Define my eye were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints|||Participants|||Number
1325804|NCT02173535|Primary|Number of Subject in Agreement (Bigger Eyes)|"Subjects' responses to the question Make my eye look bigger were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints|||Participants|||Number
1325805|NCT02173392|Secondary|Immunogenicity|Presence of binding or neutralizing anti-brodalumab antibodies|60 days||||participants|||Number
1325806|NCT02173392|Primary|Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab|Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection|60 days|Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed|||(day*mg/mL)||Standard Deviation|Mean
1325807|NCT02173392|Primary|Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.|Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection|60 days|Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two|||milligrams per milliliter||Standard Deviation|Mean
1354119|NCT01744392|Secondary|Blood Pressure at 6 Months|Clinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,|6 months||||mmHg||Standard Deviation|Mean
1325808|NCT02173379|Other Pre-specified|Patient Reported Outcomes (PRO)|"Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|5 years||2022-12-31|12/2022||||
1325809|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|3 years||2020-12-31|12/2020||||
1325810|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|1 year||2018-12-31|12/2018||||
1325811|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|6 months||2018-12-31|12/2018||||
1325812|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|1 month||2018-12-31|12/2018||||
1325813|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|Baseline||2018-12-31|12/2018||||
1325814|NCT02173379|Secondary|Number of Participants With Cumulative Stent/Scaffold Thrombosis|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|0 to 30 Days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325815|NCT02173379|Secondary|Number of Participants With Target Lesion Failure (TLF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325816|NCT02173379|Secondary|Number of Participants With Target Lesion Failure (TLF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325817|NCT02173379|Secondary|Number of Participants With Target Lesion Failure (TLF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325818|NCT02173379|Secondary|Number of Participants With Target Lesion Failure (TLF)|The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)|7 years||2024-06-30|06/2024||||
1325828|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|3-9 years||2024-06-30|06/2024||||
1325829|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|3-8 years||2024-06-30|06/2024||||
1325830|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components||3-7 years||2024-06-30|06/2024||||
1325831|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components||3-6 years||2023-12-31|12/2023||||
1325832|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components||3-5 years||2022-12-31|12/2022||||
1325833|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components||3-4 years||2021-12-31|12/2021||||
1325834|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325835|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325836|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325837|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||7 years||2024-06-30|06/2024||||
1325838|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||6 years||2023-12-31|12/2023||||
1325839|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||5 years||2022-12-31|12/2022||||
1325840|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||4 years||2021-12-31|12/2021||||
1325841|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||3 years||2020-12-31|12/2020||||
1325842|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||2 years||2019-12-31|12/2019||||
1325843|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||1 year||2018-12-31|12/2018||||
1325844|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||270 days||2018-12-31|12/2018||||
1325845|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||180 days||2018-12-31|12/2018||||
1325846|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||90 days||2018-12-31|12/2018||||
1325847|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325848|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325849|NCT02173379|Secondary|Number of Participants With Rehospitalization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325850|NCT02173379|Secondary|Number of Participants With Rehospitalization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325851|NCT02173379|Secondary|Number of Participants With Rehospitalization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325852|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|7 years||2024-06-30|06/2024||||
1325853|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|6 years||2023-12-31|12/2023||||
1325854|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|5 years||2022-12-31|12/2022||||
1325855|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|4 years||2021-12-31|12/2021||||
1325856|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|3 years||2020-12-31|12/2020||||
1325857|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|2 years||2019-12-31|12/2019||||
1325858|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|1 year||2018-12-31|12/2018||||
1325859|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|270 days||2018-12-31|12/2018||||
1325860|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|180 days||2018-12-31|12/2018||||
1325861|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|90 days||2018-12-31|12/2018||||
1325862|NCT02173379|Secondary|Number of Participants With Rehospitalization|"Coronary artery disease (CAD) related~Cardiovascular, non-CAD related~Non-cardiovascular related"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325879|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|90 days||2018-12-31|12/2018||||
1354120|NCT01744392|Secondary|Blood Pressure at Baseline|Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,|baseline||||mmHg||Standard Deviation|Mean
1325863|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained|Very late (>1 year post stent implantation)||2018-12-31|12/2018||||
1325864|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Late (30 days - 1 year post stent implantation)||2018-12-31|12/2018||||
1325865|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Subacute (>24 hours - 30 days post stent implantation)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325866|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Acute (0 - 24 hours post stent implantation)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325867|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325868|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325869|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325870|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|7 years||2024-06-30|06/2024||||
1325871|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|6 years||2023-12-31|12/2023||||
1325872|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|5 years||2022-12-31|12/2022||||
1325873|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|4 years||2021-12-31|12/2021||||
1325874|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|3 years||2020-12-31|12/2020||||
1325875|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|2 years||2019-12-31|12/2019||||
1325876|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|1 year||2018-12-31|12/2018||||
1325877|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|270 days||2018-12-31|12/2018||||
1325878|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|180 days||2018-12-31|12/2018||||
1325880|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325881|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325882|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325883|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325884|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325885|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|7 years||2024-06-30|06/2024||||
1325886|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|6 years||2023-12-31|12/2023||||
1325887|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years||2022-12-31|12/2022||||
1325888|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years||2021-12-31|12/2021||||
1325889|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|3 years||2020-12-31|12/2020||||
1325890|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|2 years||2019-12-31|12/2019||||
1325891|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|1 year||2018-12-31|12/2018||||
1325892|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|270 days||2018-12-31|12/2018||||
1325893|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|180 days||2018-12-31|12/2018||||
1325894|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|90 days||2018-12-31|12/2018||||
1325895|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325896|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325897|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325898|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325899|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325900|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|7 years||2024-06-30|06/2024||||
1325901|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|6 years||2023-12-31|12/2023||||
1354444|NCT01739361|Secondary|Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo|serum creatinine measurements at 72 hours|72 hours||||mg/dL||Inter-Quartile Range|Median
1325903|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 years||2021-12-31|12/2021||||
1325904|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|3 years||2020-12-31|12/2020||||
1325905|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|2 years||2019-12-31|12/2019||||
1325906|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|1 year||2018-12-31|12/2018||||
1325907|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|270 days||2018-12-31|12/2018||||
1325908|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|180 days||2018-12-31|12/2018||||
1325909|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|90 days||2018-12-31|12/2018||||
1325910|NCT02173379|Secondary|Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325911|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325912|NCT02173379|Secondary|Cardiac Death/TV-MI/ID-TLR (TLF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325913|NCT02173379|Secondary|Number of Participants Expereienced Cardiac Death/TV-MI/ID-TLR (TLF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325914|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325915|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|7 years||2024-06-30|06/2024||||
1325916|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|6 years||2023-12-31|12/2023||||
1325917|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|5 years||2022-12-31|12/2022||||
1325918|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|4 years||2021-12-31|12/2021||||
1325919|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|3 years||2020-12-31|12/2020||||
1325920|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|2 years||2019-12-31|12/2019||||
1325921|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|1 year||2018-12-31|12/2018||||
1325922|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|270 days||2018-12-31|12/2018||||
1325923|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|180 days||2018-12-31|12/2018||||
1325924|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|90 days||2018-12-31|12/2018||||
1325925|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325926|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325927|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325928|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325929|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|7 years||2024-06-30|06/2024||||
1325930|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|6 years||2023-12-31|12/2023||||
1325931|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|5 years||2022-12-31|12/2022||||
1325932|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|4 years||2021-12-31|12/2021||||
1325933|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|3 years||2020-12-31|12/2020||||
1325934|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|2 years||2019-12-31|12/2019||||
1325935|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|1 year||2018-12-31|12/2018||||
1325936|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|270 days||2018-12-31|12/2018||||
1325937|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|180 days||2018-12-31|12/2018||||
1325938|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|90 days||2018-12-31|12/2018||||
1325939|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325940|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325941|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325942|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325943|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325944|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|7 years||2024-06-30|06/2024||||
1326734|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Day 89-90||||minutes||Standard Deviation|Least Squares Mean
1325945|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|6 years||2023-12-31|12/2023||||
1325946|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|5 years||2022-12-31|12/2022||||
1325947|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|4 years||2021-12-31|12/2021||||
1325948|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|3 years||2020-12-31|12/2020||||
1325949|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|2 years||2019-12-31|12/2019||||
1325950|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|1 year||2018-12-31|12/2018||||
1325951|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|270 days||2018-12-31|12/2018||||
1325952|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|180 days||2018-12-31|12/2018||||
1325953|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|90 days||2018-12-31|12/2018||||
1325954|NCT02173379|Secondary|Number of Participants Experienced All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325955|NCT02173379|Secondary|Number of Participants Experienced All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325956|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325957|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325958|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325959|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|7 years||2024-06-30|06/2024||||
1325960|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|6 years||2023-12-31|12/2023||||
1325961|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|5 years||2022-12-31|12/2022||||
1325962|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|4 years||2021-12-31|12/2021||||
1325963|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|3 years||2020-12-31|12/2020||||
1325964|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|2 years||2019-12-31|12/2019||||
1325965|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|1 year||2018-12-31|12/2018||||
1325966|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|270 days||2018-12-31|12/2018||||
1325967|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|180 days||2018-12-31|12/2018||||
1325968|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|90 days||2018-12-31|12/2018||||
1325969|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325970|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325971|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325972|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325973|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325974|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|7 years||2024-06-30|06/2024||||
1325975|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|6 years||2023-12-31|12/2023||||
1325976|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|5 years||2022-12-31|12/2022||||
1325977|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|4 years||2021-12-31|12/2021||||
1325978|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|3 years||2020-12-31|12/2020||||
1325979|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|2 years||2019-12-31|12/2019||||
1325980|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|1 year||2018-12-31|12/2018||||
1325981|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|270 days||2018-12-31|12/2018||||
1325982|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR.~-TVR includes all TVR, excluding TLR"|180 days||2018-12-31|12/2018||||
1325983|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|90 days||2018-12-31|12/2018||||
1325984|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325985|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1325986|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1325987|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1325988|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1325989|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|7 years||2024-06-30|06/2024||||
1325990|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|6 years||2023-12-31|12/2023||||
1326973|NCT02150954|Secondary|Incidence of Uterine Hyperstimulation|Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.|during admission for delivery, up to approximately 4 days||||participants|||Number
1325991|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|5 years||2022-12-31|12/2022||||
1325992|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|4 years||2021-12-31|12/2021||||
1325993|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|3 years||2020-12-31|12/2020||||
1325994|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|2 years||2019-12-31|12/2019||||
1325995|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|1 year||2018-12-31|12/2018||||
1325996|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|270 days||2018-12-31|12/2018||||
1325997|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|180 days||2018-12-31|12/2018||||
1325998|NCT02173379|Secondary|Number of Participants withTarget Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|90 days||2018-12-31|12/2018||||
1325999|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326000|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326001|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1326002|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1326003|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1326004|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|7 years||2024-06-30|06/2024||||
1326005|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|6 years||2023-12-31|12/2023||||
1326006|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|5 years||2022-12-31|12/2022||||
1326007|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|4 years||2021-12-31|12/2021||||
1326008|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|3 years||2020-12-31|12/2020||||
1326009|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|2 years||2019-12-31|12/2019||||
1326010|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|1 year||2018-12-31|12/2018||||
1326011|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|270 days||2018-12-31|12/2018||||
1326012|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|180 days||2018-12-31|12/2018||||
1326014|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326015|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326016|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|10 years||2024-06-30|06/2024||||
1326017|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|9 years||2024-06-30|06/2024||||
1326018|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.|8 years||2024-06-30|06/2024||||
1326019|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|7 years||2024-06-30|06/2024||||
1326020|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|6 years||2023-12-31|12/2023||||
1326021|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|5 years||2022-12-31|12/2022||||
1326022|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years||2021-12-31|12/2021||||
1326023|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|3 years||2020-12-31|12/2020||||
1326024|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|2 years||2019-12-31|12/2019||||
1326025|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|1 year||2018-12-31|12/2018||||
1326026|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|270 days||2018-12-31|12/2018||||
1326027|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|180 days||2018-12-31|12/2018||||
1326028|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|90 days||2018-12-31|12/2018||||
1326122|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter.|||percent change||Standard Deviation|Mean
1326029|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326030|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326031|NCT02173379|Secondary|Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)|Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).|In-hospital (≤ 7days)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326032|NCT02173379|Secondary|Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)|Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.|In-hospital (≤ 7days)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of target lesions|Target lesions||Number
1326033|NCT02173379|Secondary|Number of Participants With Powered Angina|"Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).~This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first."|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326034|NCT02173379|Secondary|Powered TLF, Tested for Non-inferiority of Absorb BVS to XIENCE|This analysis will consist of ~2610 subjects in ABSORB IV.|1 year||2018-12-31|12/2018||||
1326035|NCT02173379|Primary|Number of Participants With Target Lesion Failure (TLF)|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1326036|NCT02173054|Secondary|Reduction of Severity of Acne: Acne Severity Index (ASI)|"The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)~Decrease of ASI score are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week||||units on a scale||Standard Deviation|Mean
1326037|NCT02173054|Primary|Skin Tolerability: Transepidermal Water Loss (TEWL)|Skin tolerability was assessed by measuring TEWL with the Tewameter TM300|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.||||g/m^2h||Standard Deviation|Mean
1326038|NCT02173054|Primary|Skin Tolerability: Skin Sebum Content and Skin Hydration|Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.||||µg/cm^2||Standard Deviation|Mean
1326039|NCT02173054|Secondary|Reduction of Severity of Acne|"Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks~Total acne lesions = inflammatory + noninflammatory acne lesions~Reduction of lesions counts are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week||||Lesions||Standard Deviation|Mean
1326040|NCT02173054|Primary|Reduction of Undesirable Effects|"Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.~The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown."|2nd week, 4th week, and 8th week|The reasons for drop out were lack of compliance (n=1, group A: adapalene gel alone) and consent withdrawal at patient's request (n=1, group C: adapalene with Eucerin)|||participants|||Number
1326041|NCT02172755|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p||||ng.h/mL||Standard Deviation|Mean
1326129|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline|Readings were taken from the medical record and the data may not have been present at the exact time frames.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects|||percent change||Standard Deviation|Mean
1326042|NCT02172755|Secondary|Tmax - Time of Maximum Observed Concentration|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p||||hours||Standard Deviation|Mean
1326043|NCT02172755|Primary|Maximum Drug Concentration (Cmax)|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p||||ng/mL||Standard Deviation|Mean
1326044|NCT02172742|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h|Steady-state Area Under the Plasma Concentration-time Profile Over 24 h of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose||||ng*h/mL||Standard Deviation|Mean
1326045|NCT02172742|Secondary|Tmax - Time of Occurrence of Cmax at Steady-state|Time of Occurrence of Cmax Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose||||hours||Full Range|Median
1326046|NCT02172742|Primary|Cmax - Maximum Steady-state Plasma Concentration|Cmax - Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
1326047|NCT02172625|Secondary|Superoxide Dismutase (SOD)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. This is another protective antioxidant enzyme measured from whole blood. The SOD enzymatic assay from Genova Diagnostics is designed to measure the activity of the SOD enzyme in the cytosol. The SOD assay is designed to measure the activity of SOD enzyme from whole blood. The SOD activity is determined spectrophotometrically based on the ability of the SOD compound to reduce reactive oxygen species in an enzymatic reaction necessary for the produc tion of an optically active compound.|Baseline, 30 days, 57 days, and 88 days||||U/g Hb x 1000||Standard Deviation|Mean
1326048|NCT02172625|Secondary|Whole Blood Glutathione Content (GSH)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. The total whole blood glutathione assay is designed to measure the level of glutathione in whole blood. The samples is first completely lysed and proteins are precipitated. The supernatant is then reduced and combined with a spectrophotometrically reactive compound which generates a detectable absorption peak. When compared to known concentrations of glutathione under the same reaction conditions a determination of glutathione levels in blood is determined.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community|||umol/L x 10||Standard Deviation|Mean
1326049|NCT02172625|Secondary|Total Antioxidant Capacity (TAC)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Total antioxidant capacity (TAC). The TAC measures the overall collective power of the blood to neutralize free radicals. Specifically, the TAC assay measures the antioxidant capacity of a serum sample via the ability of the antioxidants within the sample to neutralize a spectrophotometrically active compound that is optically active when oxidized. The decrease in color intensity of the compound when compared to the standard, Trolox, under the same reaction conditions is equivalent to the serum antioxidant capacity of the serum sample.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community|||mmol/L||Standard Deviation|Mean
1326050|NCT02172625|Secondary|Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)|"This is a questionnaire that assessed quality of life across 4 domains over the supplementation period.~Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable).~Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable).~Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable).~Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable)."|Baseline, 30 days, 57 days, and 88 days|Healthy community runners.|||units on a scale||Standard Deviation|Mean
1326051|NCT02172625|Secondary|Glutathione Peroxidase (GPX)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Glutathione peroxidase (GPX). This is a measure of glutathione peroxidase activity in red blood cell lysates sampled fromwhole blood. The level of GPX in the sample is determined spectrophotometrically based on the ability of the compound to catalyze a reduction reac- tion in the presence of glutathione. The change in the absorption level of the substrate is then utilized to determine the level of GPX present in the sample. The result is expressed as units of GPX relative to the gram amount of hemoglobin in the sample.|Baseline, 30 days, 57 days, and 88 days||||U/g Hb||Standard Deviation|Mean
1326052|NCT02172625|Primary|Lipid Peroxides (TBARS)|Lipid peroxides (TBARS) is a measure of oxidative damage in the blood. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline, 30 days, 57 days, and 88 days|The values reported here are the values in a fasted state. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|||umol/L||Standard Deviation|Mean
1326053|NCT02172625|Primary|5-km Running Time|5-km running performance time was measured twice at the beginning of the study, and then once post-supplementation. The best 5 km time from both initial sessions was counted as the baseline 5-km time. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline and 88 (SD 4) days|Runners from the Louisville, KY, USA, community|||minutes||Standard Deviation|Mean
1326054|NCT02172040|Secondary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
1326055|NCT02172040|Secondary|Mean Log-transformed Celecoxib Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms.|||log(ng/mL)||Standard Deviation|Mean
1326056|NCT02172040|Secondary|Mean Log-transformed Amlodipine Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms.|||log(pg/mL)||Standard Deviation|Mean
1326057|NCT02172040|Secondary|Mean Non-transformed Celecoxib Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms.|||ng/mL||Standard Deviation|Mean
1326058|NCT02172040|Secondary|Mean Non-transformed Amlodipine Plasma Concentration||24 hours post-dose on Day 14|Pharmacokinetic (PK) population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms.|||pg/mL||Standard Deviation|Mean
1326059|NCT02172040|Secondary|Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight)||Baseline and 2 weeks|ITT Population as defined for primary outcome|||mmHg||Standard Deviation|Mean
1326060|NCT02172040|Secondary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday)||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
1326061|NCT02172040|Secondary|Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
1326062|NCT02172040|Secondary|Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight)||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
1326063|NCT02172040|Secondary|Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)||Baseline and 2 weeks|ITT population as described for primary outcome|||mmHg||Standard Deviation|Mean
1326064|NCT02172040|Primary|Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk)|Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug [i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug].|1 month|Safety population: all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1326065|NCT02172040|Primary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint||Baseline and 2 weeks|Intent-to-treat (ITT): All randomized participants who received at least 1 dose of study drug and had at least a valid baseline ambulatory blood pressure monitor measurement (ABPM) and either: a) a valid Day 13-14 ABPM, where participant completed treatment or b) a valid Day 6-7 or Day 0-1 ABPM, where participant was withdrawn early.|||mmHg||Standard Deviation|Mean
1326066|NCT02171611|Secondary|Assessment of Tolerability by Investigator.|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated Set|||Percentage of Participants|||Number
1326067|NCT02171611|Secondary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with investigator defined drug−releated Adverse events.|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated set|||Percentage of participants|||Number
1326068|NCT02171611|Secondary|Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.|"Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events.~There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests."|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated Set|||Percentage of participants|||Number
1326069|NCT02171611|Secondary|Vz/F for Free Dabigatran|Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||Liter||Geometric Coefficient of Variation|Geometric Mean
1326177|NCT02169453|Primary|tEmax - Time of Occurrence of Emax||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||hours||Standard Deviation|Mean
1326070|NCT02171611|Secondary|Vz/F for Total Dabigatran|Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||Liter||Geometric Coefficient of Variation|Geometric Mean
1326071|NCT02171611|Secondary|CL/F for Free Dabigatran|Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||mL (milliliter)/min (minute)||Geometric Coefficient of Variation|Geometric Mean
1326072|NCT02171611|Secondary|CL/F for Total Dabigatran|Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||mL (milliliter)/min (minute)||Geometric Coefficient of Variation|Geometric Mean
1326073|NCT02171611|Secondary|MRTpo for Free Dabigatran|Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
1326074|NCT02171611|Secondary|MRTpo for Total Dabigatran|Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
1326075|NCT02171611|Secondary|t1/2 for Free Dabigatran|Terminal half-life of the analyte in plasma (t1/2) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
1326076|NCT02171611|Secondary|t1/2 for Total Dabigatran|Terminal half-life of the analyte in plasma (t1/2) for total dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
1326077|NCT02171611|Secondary|λz for Free Dabigatran||-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||1/hour||Geometric Coefficient of Variation|Geometric Mean
1326078|NCT02171611|Secondary|λz for Total Dabigatran|Terminal rate constant in plasma (λz) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||1/hour||Geometric Coefficient of Variation|Geometric Mean
1326079|NCT02171611|Secondary|Tmax for Free Dabigatran|Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Full Range|Median
1326080|NCT02171611|Secondary|Tmax for Total Dabigatran|Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Full Range|Median
1326081|NCT02171611|Secondary|AUC0-tz for Free Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1326082|NCT02171611|Secondary|AUC0-tz for Total Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1326083|NCT02171611|Primary|Cmax for Free Dabigatran|Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1326084|NCT02171611|Primary|Cmax for Total Dabigatran|Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1326085|NCT02171611|Primary|AUC0-inf for Free Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1326123|NCT02170519|Primary|Number of Treatment Failures|"Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:~Cardiac Index (CI) >/= 1.8 L/min/m2~Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine~MAP </= 50 mmHg (or as appropriate for age in pediatrics).~SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}"|as long as subject was on drug up to approximately 24 hours||||participants|||Number
1326086|NCT02171611|Primary|AUC0-inf for Total Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PK-Per protocol set (PK-PPS): This subject set included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations with respect to the evaluation of relative bioavailability and who did not vomit at or before 2 times the median tmax.|||ng(nanogram)*h(hour)/mL(milliliter)||Geometric Coefficient of Variation|Geometric Mean
1326087|NCT02171247|Primary|Attenuation of the Ascending Aorta and Coronary Arteries|The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.|during scan, approximately 3 hours||||CNR||Standard Deviation|Mean
1326088|NCT02171247|Primary|Motion Artifact|The outcome will be measured by individual scores. The scores from multiple readers will be averaged.|during scan, approximately 3 hours|Data was not collected and therefore not analysed||||||
1326089|NCT02171247|Primary|Image Quality|Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.|during scan, approximately 3 hours||||% of coronary branches visualized|||Number
1326090|NCT02171247|Primary|Contrast to Noise Ratio|Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation − myocardium attenuation) / SD of mean noise attenuation.|during scan, approximately 3 hours||||CNR||Standard Deviation|Mean
1326091|NCT02171234|Primary|Total Number of Adverse Events|Total Number of Adverse Events.|up to 20 weeks||||Total Number of AE|||Number
1326092|NCT02171234|Secondary|AUC0-τ|"AUC0-τ - Area under the plasma concentration time curve to last measurable time point~Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose"|Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose||||ng.h/ml||Standard Deviation|Mean
1326093|NCT02171234|Secondary|Cmax|Cmax - Maximum observed plasma concentration|Day 1 and Day 8||||ng/ml||Standard Error|Mean
1326094|NCT02171195|Primary|Total Number of Adverse Events|An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product|up to 20 weeks||||Number of Adverse Events|||Number
1326095|NCT02170779|Secondary|Beck Depression Inventory II (BDI II)|"The BDI-II is a standardized self-report questionnaire to quantify depression.~The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63."|at average of 4 months||||units on a scale||Standard Deviation|Mean
1326096|NCT02170779|Secondary|Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)|"The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity.~The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352."|at average of 4 months||||units on a scale||Standard Deviation|Mean
1326097|NCT02170779|Secondary|Spasticity Measured by the Modified Ashworth Scale|"The modified Ashworth Scale is a standard clinical and research method to quantify spasticity.~Each of the 6 leg groups is given a scale of 0-4.~0 - Normal. No increase in muscle tone.~- Mild. Barely increased muscle tone. (catch)~- Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance)~- Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop)~- Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24."|at average of 4 months||||units on a scale||Standard Deviation|Mean
1326098|NCT02170779|Secondary|Multiple Sclerosis Impact Scale (MSIS-29)|"The MSIS-29 is designed to measure the physical and psychological impact of MS.~Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact."|at average of 4 months||||units on a scale||Standard Deviation|Mean
1326099|NCT02170779|Secondary|Modified Fatigue Impact Scale (MFIS)|This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue.|at average of 4 months||||units on a scale||Standard Deviation|Mean
1326100|NCT02170779|Secondary|2 Minute Walk Test|The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured.|at average of 4 months|One subject was unable to complete this physical assessment at the visit.|||feet||Standard Deviation|Mean
1326101|NCT02170779|Secondary|Timed up and go Test|"The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair.~The best score of the two attempts was analyzed."|at average of 4 months|One subject was unable to complete this physical assessment at the visit.|||seconds||Standard Deviation|Mean
1326102|NCT02170779|Secondary|Timed 25 Foot Walk|"The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects.~The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet."|at average of 4 months|One subject was unable to complete this physical assessment at the visit.|||seconds||Standard Deviation|Mean
1326124|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
1326125|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.|||percent change||Standard Deviation|Mean
1326103|NCT02170779|Primary|MS Walking Scale-12 (MSWS-12)|"The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time.~Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient’s score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability."|at average of 4 months||||units on a scale||Standard Deviation|Mean
1326104|NCT02170688|Primary|Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU)|Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement.|baseline, post-dose imaging (approximately 1hr)||||Hounsfield units (HU)||Standard Deviation|Mean
1326105|NCT02170688|Secondary|Difference in Volume of Contrast Used, Measured in Milliliters||baseline, post-dose imaging (approximately 1hr)||||Milliliters||Standard Deviation|Mean
1326106|NCT02170662|Secondary|Percent Change in Hair Diameter|The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.|Baseline to week 17; Week 17 to week 34|Data not analyzed, and therefore not reported.||||||
1326107|NCT02170662|Secondary|Percent Change in the Target Area Vellus Hair Count|Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness|Baseline to week 17; and week 17 to week 34||||Percent change of vellus hair count||Full Range|Mean
1326108|NCT02170662|Secondary|Percent Change in the Target Area Terminal Hair Count|Terminal hairs are those which grow beyond a cm and contribute to overall hair density.|Baseline to week 17; and week 17 to week 34||||percent change of terminal hair count||Full Range|Mean
1326109|NCT02170662|Primary|Percent Change in Target Area Total Hair Count|The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.|Baseline to week 17; and week 17 to week 34|intention to treat (ITT)|||percentage change in total hair count||Full Range|Mean
1326110|NCT02170649|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo)|Area under the plasma concentration versus time curve from time zero to infinity (AUC0-oo) of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||ng.h/mL||Standard Deviation|Mean
1326111|NCT02170649|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t)|Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||ng.h/mL||Standard Deviation|Mean
1326112|NCT02170649|Secondary|Time of Occurrence of Cmax (Tmax)|Time of occurrence of Cmax of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||hours||Full Range|Median
1326113|NCT02170649|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||ng/mL||Standard Deviation|Mean
1326114|NCT02170532|Secondary|Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.||||||
1326115|NCT02170532|Secondary|Change in Tremor Assessment Measured by a Scale|Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).|Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.||||||
1326116|NCT02170532|Secondary|Change in Heart Rate||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.||||||
1326117|NCT02170532|Secondary|Change in 8 Hour Area-under-the-curve FEV1||0 to 8 hours post dose||||percentage of change||Standard Deviation|Mean
1326118|NCT02170532|Primary|Change in Maximum Forced Expiratory Volume at One Second (FEV1)||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|The same 10 subjects received each of the 5 treatments in the same order. Subjects 1-5 were not included in 6 and 8 hour time points.|||percentage of change||Standard Deviation|Mean
1326119|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
1326120|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline|SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.|||percent change||Standard Deviation|Mean
1326121|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
1326126|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
1326130|NCT02170376|Primary|t1/2 - Terminal Plasma Half-life|t1/2 - Terminal plasma half-life of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||Hours||Standard Deviation|Mean
1326131|NCT02170376|Primary|AUC0-5 - AUC Over 5 Hours|AUC0-5 - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng.h/mL||Standard Deviation|Mean
1326132|NCT02170376|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.|AUC0-t - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng.h/mL||Standard Deviation|Mean
1326133|NCT02170376|Primary|AUC0-∞ - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase|AUC0-∞ of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng.h/mL||Standard Deviation|Mean
1326134|NCT02170376|Primary|Tmax - Time of Occurrence of Maximum Plasma Concentration|Tmax - Time to Reach maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||hours||Standard Deviation|Mean
1326135|NCT02170376|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng/mL||Standard Deviation|Mean
1326136|NCT02170363|Secondary|Stroke Free Survival|Percentage of participants free of debilitating stroke (Modified Rankin Score > 3)|6 months||||percentage of participants|||Number
1326137|NCT02170363|Secondary|Rehospitalizations|Frequency and incidence of rehospitalizations|As they occurred, Baseline through 180 Days|Number of Participants with Rehospitalizations According to Rehospitalization Type|||Participants|||Count of Participants
1326138|NCT02170363|Secondary|Reoperations|Frequency of reoperations|As they occurred, Baseline through 180 Days|Twenty-nine (58%) did not have reoperation|||Number of re-operations by reason|||Number
1326139|NCT02170363|Secondary|Device Malfunctions|Frequency and incidence of device malfunction|As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome||||Number of events|||Number
1326140|NCT02170363|Secondary|All Adverse Events|Frequency of pre-defined anticipated adverse events|As they occurred, Baseline through 180 Days||||% of Participants with Adverse Events|||Number
1326141|NCT02170363|Secondary|Functional Status - New York Heart Association (NYHA) Classification|NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|Baseline, Month 1, Month 3, Month 6|Only patients alive, capable and willing to perform test are included.|||percentage of participants|||Number
1326142|NCT02170363|Secondary|Functional Status - Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|Baseline, Month 1, Month 3, Month 6|Only patients alive, capable and willing to perform test are included.|||meters||Full Range|Median
1326143|NCT02170363|Secondary|Quality of Life (EQ-5D-5L)|The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.|Baseline, Month 1, Month 3, Month 6|Patients alive and capable of performing the test at 6 months|||Units on a EQ-5D-5L Score scale||Full Range|Median
1326144|NCT02170363|Primary|Survival|Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data|6 months|All 50 patients were analyzed when the last patient reached the 6-month primary endpoint on May 26, 2015|||Percentage of Participants who Survived||97.5% Confidence Interval|Number
1326145|NCT02170220|Primary|Cmaxu: Maximum Observed Unbound Plasma Concentration for Vortioxetine|Maximum Observed Unbound Plasma Concentration (Cmaxu) is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
1326178|NCT02169453|Primary|Emax - Maximum Inhibition of COMT Activity|Emax - Maximum inhibition of Catechol-O-Methyltransferase (COMT) activity|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||pmol/mg Hb/h||Standard Deviation|Mean
1326146|NCT02170220|Primary|AUC(0-inf)u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf)u is a measure of total unbound plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1326147|NCT02170220|Primary|AUC(0-tlqc)u: Area Under the Unbound Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|AUC(0-tlqc)u is a measure of total unbound plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]u).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1326148|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA39835|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
1326149|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA34443|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
1326150|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
1326151|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine Metabolite Lu AA34443|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1326152|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1326153|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA39835|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1326154|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA34443|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1326155|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|Pharmacokinetic (PK) Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
1326156|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 17 (8 weeks after the last dose of study drug)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326157|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326179|NCT02169453|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng.h/mL||Standard Deviation|Mean
1326158|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326159|NCT02170207|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326160|NCT02170207|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1326161|NCT02170077|Primary|"The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as Responders) in a Treatment Period Compared to the Baseline Period"||baseline, week 12||||percentage of responders|||Number
1326162|NCT02170064|Secondary|Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase|"The efficacy variables were the percentage change in seizure frequency during each 4-week treatment period compared to the baseline phase.~Seizures were recorded in the patient’s diary during the baseline phase and during the following 4-week treatment periods.~Seizure frequency for each patient was standardised to a frequency per 28 days period (i.e., mean daily frequency multiplied by 28). Changes in seizure frequency were analysed for each age group separately."|Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).||||percent change||95% Confidence Interval|Median
1326163|NCT02170064|Primary|Time of Occurrence of Cmax (Tmax).||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose||||hours||Standard Deviation|Mean
1326164|NCT02170064|Primary|Maximum Observed Plasma Drug Concentration (Cmax) Post-dose||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose||||ng/mL||Standard Deviation|Mean
1326165|NCT02170025|Primary|Change of Sweat Chloride Content From Baseline|Sweat chloride samples were obtained by using a Macroduct induction and collection device according to standard procedures.|Baseline, at day 14 and day 28 in study part 1|Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.|||mmol/L||Standard Deviation|Mean
1326166|NCT02169895|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|AUC0-t - area under the plasma concentration-time curve of benserazide.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.||||ng.h/mL||Standard Deviation|Mean
1326167|NCT02169895|Primary|Tmax - Time of Occurrence of Cmax|tmax - time of occurrence of Cmax of benserazide|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||hours||Full Range|Median
1326168|NCT02169895|Primary|Maximum Observed Plasma Drug Concentration (Cmax)|Cmax - Maximum observed plasma drug concentration of benserazide|pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng/mL||Standard Deviation|Mean
1326169|NCT02169479|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Area under the plasma concentration-time curve for levodopa|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng.h/mL||Standard Deviation|Mean
1326170|NCT02169479|Primary|Tmax - Time of Occurrence of Cmax of Levodopa|Tmax - time of occurrence of Cmax of levodopa.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||hours||Full Range|Median
1326171|NCT02169479|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng/mL||Standard Deviation|Mean
1326172|NCT02169466|Primary|Tmax - Time to Cmax|Primary pharmacokinetic parameter: tmax - time to Cmax|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||hours||Full Range|Mean
1326173|NCT02169466|Primary|AUC0-∞ - AUC From Time Zero to Infinity|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||ng.h/mL||Standard Deviation|Mean
1326174|NCT02169466|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||ng.h/mL||Standard Deviation|Mean
1326175|NCT02169466|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||ng/mL||Standard Deviation|Mean
1326176|NCT02169453|Primary|AUEC0-24 - Area Under the Effect-time Curve From t=0h to t=24h||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||pmol/mg Hb/h.h||Standard Deviation|Mean
1326180|NCT02169453|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - Area under the plasma concentration-time curve to last measurable time point for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng.h/mL||Standard Deviation|Mean
1326181|NCT02169453|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng/mL||Standard Deviation|Mean
1326182|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng.h/mL||Standard Deviation|Mean
1326183|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||hours||Full Range|Median
1326184|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng/mL||Standard Deviation|Mean
1326185|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng.h/mL||Standard Deviation|Mean
1326186|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||hours||Full Range|Median
1326187|NCT02169440|Primary|Cmax = Maximum Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng/mL||Standard Deviation|Mean
1326188|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng.h/mL||Standard Deviation|Mean
1326189|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||hours||Full Range|Median
1326190|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng/mL||Standard Deviation|Mean
1326191|NCT02169427|Secondary|Tmax - Time to Attain Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29||||hours||Standard Deviation|Mean
1326192|NCT02169427|Secondary|Cmax - Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29||||ng [eq]/mL||Standard Deviation|Mean
1326193|NCT02169427|Primary|Cumulative Recovery of [14C]-Radioactivity|"AEurine: Cumulative Recovery of [14C]-Radioactivity in urine AEfaeces: Cumulative Recovery of [14C]-Radioactivity in urine AEair: Cumulative Recovery of [14C]-Radioactivity in urine AEtotal: Cumulative Recovery of [14C]-Radioactivity in urine~Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards"|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29||||Recovery % of dose||Standard Deviation|Mean
1326194|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose||||ng.h/mL||Standard Deviation|Mean
1326195|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
1326196|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||hours||Standard Deviation|Mean
1326197|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide )|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1326282|NCT02167139|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24||||percentage of participants|||Number
1326198|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa)|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
1326199|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
1326200|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||hours||Standard Deviation|Median
1326201|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1326202|NCT02169336|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48).|Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|48 hours||||units on a scale||Standard Deviation|Mean
1326203|NCT02169219|Secondary|Vasculitis Damage Index (VDI)|The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60.|24 months||||units on a scale||Inter-Quartile Range|Mean
1326204|NCT02169219|Secondary|Early Treatment Failures|Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry|4 weeks||||Participants|||Count of Participants
1326205|NCT02169219|Secondary|Severe Flares|Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items|6 months||||Participants|||Count of Participants
1326206|NCT02169219|Secondary|Limited Flares|Number of limited flares defined as a new occurrence or worsening of one or more minor BVAS/WG items and a total BVAS/WG ≤ 3|6 months||||Participants|||Count of Participants
1326207|NCT02169219|Secondary|Sustained Complete Remission|Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period.|6 months||||Participants|||Count of Participants
1326208|NCT02169219|Secondary|Partial Remission|Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3.|8 weeks||||Participants|||Count of Participants
1326209|NCT02169219|Secondary|Disease Response|Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score at 4 weeks.|4 weeks|Number of patients having a disease response|||Participants|||Count of Participants
1326210|NCT02169219|Primary|Complete Remission|We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months.|6 months||||Participants|||Count of Participants
1326211|NCT02169115|Secondary|To Assess the Safety of Omalizumab in UF Patients|Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|112 days|||||||
1326212|NCT02169115|Secondary|To Assess Long-term Effects of Omalizumab in UF Patients|To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed|112 days|||||||
1326213|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity|Change in patient global assessment of disease severity assessed by visual analogue scale by the patient from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days|||||||
1326214|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity|Change in physician global assessment of disease severity assessed by visual analogue scale by a physician from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days|||||||
1326215|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days|Change in number of symptom free days as assessed by a patient diary from baseline to day 70 after treatment with omalizumab compared to placebo|70 days|||||||
1326216|NCT02169115|Secondary|To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life|Change in quality of life scores assessed by Dermatology Life Quality Index (DLQI) and UF specific life quality questions from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days|||||||
1326217|NCT02169115|Primary|Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo|Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.|70 days||||wheal development up to four pins||Standard Deviation|Mean
1326218|NCT02168816|Secondary|Number of Participants With Ulcer Resolution|Six months following completion of treatment, the researchers record whether each participant's ulcer has resolved.|Six Months|The analysis population comprises all randomized participants who had a six month follow-up appointment.|||Participants|||Count of Participants
1326219|NCT02168816|Primary|Number of Participants With Bone Infection|Six months following completion of treatment, the researchers record evidence of bone infection for each participant. A negative diagnosis is made when there is (i) an absence of infection based on clinical examination and (ii) down-trending of inflammatory markers. Otherwise, a positive diagnosis is made.|Six Months|The analysis population comprises all randomized participants who had a six month follow-up appointment.|||Participants|||Count of Participants
1326220|NCT02168777|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Dose-limiting toxicities (DLTs) were analyzed in the maximum tolerated dose (MTD) analysis set, in which only the six first patients of each dose escalation Cohort could be included according to the modified Rolling-6 method that was applied in this study.|At Cycle 1|MTD analysis set: all participants who completed Cycle 1 or discontinued during Cycle 1 due to an adverse event or DLT in the dose escalation part.|||Participants|||Number
1326221|NCT02168777|Secondary|Progression-free Survival During Phase 2|Progression-free survival was defined as the time from date of treatment assignment to date of first observed disease progression or death due to any cause, if death occurred while the participant was in the study and before progression was observed.|From start of treatment until progression is documented|Phase 2 part was not conducted.||||||
1326222|NCT02168777|Secondary|Time to Progression During Phase 2|Time to progression was defined as the time (days) from the treatment start date to the disease progression on or following the start date. Participants not experiencing progression at the database cutoff date for primary completion were censored at the last assessment.|From start of treatment until progression is documented|Phase 2 part was not conducted.||||||
1326223|NCT02168777|Secondary|Overall Survival During Phase 2|Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date.|Up to 12 months after last patient first visit|Phase 2 part was not conducted.||||||
1326224|NCT02168777|Secondary|Tumor Response During Phase 1b as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target and non-target tumor lesions, PR was defined as a decrease of at least 30% in the sum of diameters of target lesions, SD was defined neither sufficient shrinkage for PR nor sufficient increase for PD, PD was defined as an increase of at least 20% in the sum of diameters of target lesions.|From start of treatment until progression is documented|Full analysis set|||Participants|||Number
1326225|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Multiple Dose (Tmax,md) for Regorafenib and Its Metabolites M-2 and M-5|Time to reach maximum drug concentration in plasma after multiple dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose. On Day 21, one patient in Cohort 0 was dose reduced and the other patient was not dosed. Therefore no patient was evaluable.|||h||Full Range|Median
1326226|NCT02168777|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 h (AUC(0-24)) After Single (First) Dose for Regorafenib and Its Metabolites M-2 and M-5|Area under the plasma concentration-time curve from 0 to 24 h after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose|PK analysis set for single dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
1326227|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Regorafenib and Its Metabolites M-2 and M-5|Time to reach maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose|PK analysis set for single dose.|||h||Full Range|Median
1326228|NCT02168777|Secondary|Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Regorafenib and Its Metabolites M-2 and M-5|Maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose|PK analysis set for single dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
1326229|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Multiple Dose (Tmax,md) for Refametinib and Its Metabolite M-11|Time to reach maximum drug concentration in plasma after multiple dose for Refametinib and its metabolite M-11. Median and full range were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose. On Day 21, one patient in Cohort 0 was dose reduced and the other patient was not dosed. Therefore no patient was evaluable.|||h||Full Range|Median
1326230|NCT02168777|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 8 h (AUC(0-8)) After Single (First) Dose for Refametinib and Its Metabolite M-11|Area under the plasma concentration-time curve from 0 to 8 h after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose|PK analysis set for single dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
1326231|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Refametinib and Its Metabolite M-11|Time to reach maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Median and full range were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose|PK analysis set for single dose.|||h||Full Range|Median
1326373|NCT02164864|Secondary|Time to First Adjudicated MI|Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326232|NCT02168777|Secondary|Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Refametinib and Its Metabolite M-11|Maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose|PK analysis set for single dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
1326233|NCT02168777|Primary|Tumor Response During Phase 2 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|Up to 12 months|Phase 2 part was not conducted.||||||
1326234|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-5|Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
1326235|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-2|Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
1326236|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib|Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
1326237|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-5|Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
1326238|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-2|Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
1326239|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib|Maximum drug concentration in plasma after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
1326240|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib Metabolite M-11|Area under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
1326241|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib|Area under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
1326242|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11|Maximum drug concentration in plasma after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
1326243|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib|Maximum drug concentration in plasma after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|Pharmacokinetic (PK) analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
1326244|NCT02168491|Secondary|Change in Body Weight From Baseline to End of Study|A change between two time points is reported. Time Frame: baseline and 12 weeks.|12 weeks||||weight in kg||Standard Deviation|Mean
1326245|NCT02168491|Secondary|Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)|"Patients will be instructed to record all insulin injections and a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) during a one-week prestudy run-in period to confirm compliance and document current metabolic control and doses of premixed insulin.~Patients will be asked to record not only glucose profiles (at least 4 measurements per day) but also the occurrence of hypoglycemic symptoms or other adverse effects daily throughout the study.~During the last week of the study patients will be asked to again record a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) and drug injections to confirm compliance and document metabolic control."|12 weeks||||glucose in mg/dl||95% Confidence Interval|Mean
1326246|NCT02168491|Primary|Change in HbA1c From Baseline to End|A change between two time points is reported. Time Frame: baseline and 12 weeks.|12 weeks||||HbA1c in percent||Standard Deviation|Mean
1326247|NCT02168478|Primary|Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)|"ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). 0= no visible erythema; 0.5= slight, barely perceptible erythema; 1= mild erythema; 2= moderate erythema; 3= marked erythema; 4= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization."|48, 96 and 168 Hours||||percentage of patients w allergic rxn|||Number
1326248|NCT02168439|Other Pre-specified|Anxiolysis Satisfaction|"Likert scale parent, child life and proceduralist survey~5 point likert scale asking how satisfied the parent or proceduralist is with the anxiolysis from the medication.~1 being not satisfied at all, 3 neutral, 5 very satisfied."|Day 1||||units on a scale||Standard Deviation|Median
1326249|NCT02168439|Other Pre-specified|Need for Procedural Sedation|Whether the patient required procedural sedation for completion of the procedure|Day 1||||percentage of participants|||Number
1326250|NCT02168439|Other Pre-specified|Procedure Completion|note of whether the procedure was able to be completed|Day 1||||percentage of participants|||Number
1326251|NCT02168439|Secondary|VAS for Anxiety as Completed by Caregiver and Observer|"VAS, Visual Analog Scale for anxiety. Scale from 0-10 written on a 10 cm horizontal line with the extremes labeled as no anxiety to very anxious.~Vertical line is drawn on the scale at the level of anxiety. The distance was measured.~Higher numbers equal higher anxiety."|Day 1||||units on a scale||Standard Deviation|Mean
1326252|NCT02168439|Secondary|mYPAS Scores at Other Time Points|mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.|Day 1||||units on a scale||95% Confidence Interval|Median
1326253|NCT02168439|Primary|mYPAS Score as Completed by Researchers to Assess Anxiety|"Primary outcome was the mYPAS scores at the time of positioning for procedure.~mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious."|Day 1||||units on a scale||95% Confidence Interval|Median
1326254|NCT02168387|Secondary|Change in Quantity and Quality of Suctioned Mucus||baseline and 48 hours|These data were not obtained due to technical difficulties.||||||
1326255|NCT02168387|Secondary|Change in Capnography (Vd/Vt)|The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement.|baseline and 48 hours||||ratio||Standard Deviation|Mean
1326256|NCT02168387|Primary|Improvement of Atelectasis|"An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows:~0 Complete resolution of collapse~Partial collapse of 1 segment or lobe~Partial collapse of ≥ 2 segments or lobes~Complete collapse of 1 segment or lobe~Complete collapse of ≥ 2 segments or lobes~In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation)."|after 48 hours of therapy||||participants|||Number
1326257|NCT02168361|Secondary|Serum HCV RNA Level||4 and 12 weeks into therapy|All participants that received at least a single dose of medication|||IU/ml||Full Range|Median
1326258|NCT02168361|Primary|Proportion of Participants With Sustained Virologic Response 12 (SVR-12)|Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy|12 weeks post-therapy|All participants that received at least a single dose of medication|||participants|||Number
1326259|NCT02168309|Secondary|Total Length of Hospital Stay in Days|Secondary outcome|0-10 days||||days||Standard Deviation|Mean
1326260|NCT02168309|Primary|Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication|Primary outcome|24 hours||||hours||Standard Deviation|Mean
1326261|NCT02168270|Secondary|Using Radiologic Measurements for Tumor Response|The measurement of effect will be based on the Macdonald criteria|Up to 52 weeks|This outcome measure was not analyzed as all patients had progressive disease by 2 cycles of treatment.||||||
1326262|NCT02168270|Secondary|Changes in Serum Levels of Ascorbic Acid (Using HPLC With Coulometric Electrochemical Detection)|Correlation of intracellular glutathione (in peripheral blood mononuclear cells) with ascorbic acid levels during therapy with ascorbic acid and temozolomide will be summarized using descriptive statistics to summarize changes over time.|Baseline to up to 52 weeks|No patients were analyzed as all experienced progressive disease after 2 cycles of treatment.||||||
1326263|NCT02168270|Primary|Incidence Rates of Adverse Events, Graded According to the NCI Common Toxicity Criteria for Adverse Events Version 4.0|The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.|Up to 30 days after last administration of study medication|This study was terminated after only 4 patients enrolled. Incidence rates of adverse event could not be describe by dose level.||||||
1326264|NCT02168270|Primary|Maximum Tolerated Dose of Ascorbic Acid in Combination With Temozolomide, Defined as the Highest Dose Tested Which Results in Dose Limiting Toxicity (DLT) in no More Than One of Six Evaluable Patients|Graded by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 4.0. DLT incidence will be described by dose level.|56 days|This study was terminated as subjects had disease progression so no subjects were evalable.||||||
1326265|NCT02167893|Secondary|Percentage of Participants With Disease-specific Survival|Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.|Baseline up to 96 weeks|No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.||||||
1326266|NCT02167893|Secondary|Percentage of Participants With Metastasis-free Survival||Baseline up to 96 weeks|No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.||||||
1326974|NCT02150954|Secondary|Time to Foley Expulsion or Removal|Time from foley balloon placement until the expulsion or removal of the foley balloon.|foley bulb placement until removal, up to 10 hours||||hours||Inter-Quartile Range|Median
1326267|NCT02167893|Secondary|Percentage of Participants With Overall Survival (OS) Based on TNM Classification|OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis.|Baseline up to 96 weeks or death (which ever occurs first)|The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
1326268|NCT02167893|Secondary|Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification|PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis.|Baseline up to 96 weeks|The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
1326269|NCT02167893|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 96|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1326270|NCT02167893|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 96|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1326271|NCT02167867|Primary|Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6|Circumference in inches for the waist, hips and both thighs were measured and added together to give a total circumference measurement at baseline and at the end of the 2 weeks of treatment. The change in the total circumference measurement from baseline to the end of treatment was calculated. A decrease (-) in circumference measurement suggests study success and an increase (+) in circumference measurement suggests study failure. A decrease (-) of 3.52 inches (-3.52 inches) or more is positive for study success based on prior published results.|Baseline and 2 weeks||||inches||Standard Deviation|Mean
1326272|NCT02167867|Primary|Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions.|The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated|two weeks||||participants|||Number
1326273|NCT02167867|Primary|Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments|The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated.|Baseline||||participants|||Number
1326274|NCT02167815|Secondary|Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.||16 weeks|the way to collect data differed to much betwen the sites, no analysis could be done.||||||
1326275|NCT02167815|Secondary|Users Feedback After Handling or Use as a Measure of Performance.|"Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor~1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition."|16 weeks||||participants|||Number
1326276|NCT02167815|Secondary|Pain Scores on the Visual Analog Scale|Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.|16 weeks||||units on a scale (VAS)||Standard Deviation|Mean
1326277|NCT02167815|Primary|Changes From Baseline in Condition of the Peri Wound Skin|Deteriorationin of skin condition , Mepilex XT and Standard care (%)|16 weeks|Intention to treat, change from baseline in condition of the peri-wound skin.|||percentage of subjects|||Number
1326278|NCT02167217|Primary|Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)|Bayley III Gross Motor Scaled Score measures motor development. This is normed for typically developing children and follow a bell shaped curve. The scale has mean of 10 +/-3 for children at all ages and is bell shaped. Therefore the two standard deviation range is 16 to 4 with higher values indicated better performance. Lower values have been shown to be common in boys with DMD and it this study the baseline average score was 4.2.|One year|We analyzed the change in the gross motor score after one year. An increase indicates improvement compared to peers|||units on a scale||Standard Deviation|Mean
1326279|NCT02167139|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 24, Week 52|||||||
1326280|NCT02167139|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52||||percentage of participants|||Number
1326281|NCT02167139|Secondary|ACR20||Week 52||||percentage of participants|||Number
1326283|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events/1,000 person-years|||Number
1326284|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events/1,000 person-years|||Number
1326285|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events/1,000 person-years|||Number
1326286|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events|Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events per 1,000 person-years|||Number
1326287|NCT02166697|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)|SADR are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Number
1326288|NCT02166697|Primary|Number of Participants Reporting One or More Adverse Drug Reactions (ADR)|ADR are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Number
1326289|NCT02166476|Secondary|Pharmacokinetic (PK) Characterization Of Plasma Exposure Of Meropenem/Vaborbactam|"This outcome measure focused on PK assessment of participants in the meropenem/vaborbactam group who met MITT criteria and had at least 1 plasma PK sample drawn. Sparse PK sampling on Day 1 was performed 3-3.5 hours and 5-6 hours after the start of the first 3-h IV study drug infusion. Samples were not collected around the 30-minute infusions. Samples were collected from both groups to maintain the blind; however, only PK samples for the meropenem/vaborbactam group were analyzed. The area under the curve (AUC) was generated using a Population PK model and post hoc estimates of each participants' PK parameters, including AUC0-24, were generated.~The AUC during 24 hours (AUC0-24) for Day 1 and at steady-state are presented in micrograms (ug)·hour/mL."|Day 1|PK population: Participants in the MITT population (all participants screened, randomized, and received at least 1 dose of study drug) and had at least 1 plasma PK sample drawn. Due to renal impairment, 28 participants received a reduced dose of the study drug (1 g meropenem/1 g vaborbactam).|||ug·hour/mL||Standard Deviation|Mean
1326290|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (EMA) In The ME Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the EMA criteria as a reduction in baseline bacterial pathogen(s) to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
1327839|NCT02135432|Secondary|Number of Adverse Events Experienced by the Ivacaftor Subjects and Placebo Subjects.|Number of adverse events per subject in each the Ivacaftor subjects and placebo subjects|baseline to 2 weeks||||adverse events|||Number
1326291|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (EMA) In The m-MITT Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the EMA criteria as a reduction in baseline bacterial pathogen(s) to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
1326292|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (FDA) In The ME Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the FDA criteria as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
1326293|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (FDA) In The m-MITT Population|This secondary outcome measure focused on the per-pathogen (Enterobacter cloacae [E. cloacae], Enterococcus faecalis [E. faecalis], Escherichia coli [E. coli], Klebsiella pneumoniae [K. pneumoniae]) microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the FDA criteria as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
1326294|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The ME Population|This secondary outcome measure focused on a clinical outcome of Cure in the ME population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
1326295|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The Clinical Evaluable (CE) Population|This secondary outcome measure focused on a clinical outcome of Cure in the CE population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|CE population: all participants who received ≥1 dose of drug (MITT), had no key inclusion/exclusion criteria violations, had a clinical outcome (Cure, Improvement, Failure) at EOIVT, received 80-120% of expected IV doses, missed ≤1 IV dose in the first 48 hours, missed ≤2 consecutive IV doses overall, received ≥6 doses (Failure) or ≥9 doses (Cure).|||Participants|||Count of Participants
1326296|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The m-MITT Population|This secondary outcome measure focused on a clinical outcome of Cure in the m-MITT Population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
1326372|NCT02164864|Secondary|Time to First Adjudicated Stroke|"Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.~Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction"|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326297|NCT02166476|Secondary|Proportion Of Participants In The ME Population Who Achieved A Microbiologic Outcome Of Eradication|This secondary outcome measure focused on a microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture (FDA) or <10^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
1326298|NCT02166476|Secondary|Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication|This secondary outcome measure focused on a microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, end of treatment (EOT), TOC, and late follow up (LFU). Eradication was defined as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture (FDA) or <10^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as a uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
1326299|NCT02166476|Secondary|Proportion Of Participants In The ME Population With Overall Success|This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14) and TOC (Days 15-23)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
1326300|NCT02166476|Secondary|Proportion Of Participants In The m-MITT Population With Overall Success|This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success at TOC was defined as a clinical outcome of Cured and a microbiologic outcome of Eradication. Overall success at EOIVT was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14) and TOC (Days 15-23)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
1326301|NCT02166476|Primary|Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit|This was the primary outcome measure for the EMA. For this measure, a microbiologic outcome of Eradication was defined using the EMA’s CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). The ME population included all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|TOC (Days 15-23)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
1326302|NCT02166476|Primary|Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit|This was the primary outcome measure for the European Medicines Agency (EMA). For this measure, a microbiologic outcome of Eradication was defined using the EMA’s CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Test of cure (TOC) (Days 15-23)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
1326310|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Peripheral Volume (Vp/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Vp/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||L|||Number
1326303|NCT02166476|Primary|Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit|This was the primary outcome measure for the Food and Drug Administration (FDA). For this composite outcome measure, overall success was achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at the end of intravenous treatment (EOIVT). Cure was defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. Eradication was defined using the FDA's colony-forming units (CFU)/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
1326304|NCT02166346|Secondary|Upper and Lower Extremity Muscle Strength Measurements|Upper and lower extremity muscle strength measurements, using a hand held dynamometer, at the beginning and end of each arm. Change in muscle strength between baseline and end (8 weeks) of each intervention are provided.|baseline and end (8 weeks) of each intervention||||Pounds||95% Confidence Interval|Mean
1326305|NCT02166346|Primary|Walking Speed During Timed 25-foot Walk|In this cross-over study, walking speed was recorded 4 times for each subject while in both the dalfampridine and placebo arms. The results average all of the times while on damfampridine and compares them to the average of the times while on placebo.|Every 2 weeks during each 8 week intervention|In this cross-over study, walking speed was recorded 4 times for each subject while in both the dalfampridine and placebo arms. The results average all of the times while on damfampridine and compares them to the average of the times while on placebo.|||feet/second||Full Range|Mean
1326306|NCT02165826|Secondary|Median Simulated Absolute Change From Baseline in FEV1 at Weeks 4 and 12|The PK model predicted the total PDE4 inhibitory activity and the median simulated Change from Baseline (CFB) in FEV1 at Week 4 and the Change from Baseline in FEV1 at Week 12 during 12 weeks of treatment with roflumilast 500 μg OD based on 1000 participants simulated. Results are reported for the set of reference participants defined according to the covariates [weight, smoking status, sex, age, race, COPD severity, concomitant long acting muscarinic antagonist (LAMA) and Percent FEV1 reversibility] included in the final model and tPDE4i. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. FEV-1: Pre-dose and Weeks 4 and 12|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration. The number of participants analyzed is the number of participants simulated. Measured values are predicted values.|||milliliters (mL)|||Number
1326307|NCT02165826|Secondary|Median Simulated Percentage of Participants With Adverse Events of Interest|The PK model predicted the total PDE4 inhibitory activity and the median simulated percentage of participants with Adverse Events of Interest during 12 weeks of treatment based on 1000 participants simulated. Results are reported for the set of reference participants defined according to the covariates [weight, smoking status, sex, age and long acting muscarinic antagonist (LAMA)] included in the final model and tPDE4i. Adverse Events of Interest (AEI) for PK analyses included: headache, diarrhea, nausea, vomiting, abdominal pain, appetite disorders, sleep disorders, angioedema, psychiatric disorders (anxiety, nervousness), psychiatric disorders (depression, suicidal ideation, behaviour) and weight loss.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. AEIs: 12 Weeks|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration. Number of participants analyzed is the number of participants simulated. Measured values are predicted values.|||percentage of participants|||Number
1326308|NCT02165826|Secondary|Summary Statistics of Predicted Total PDE4 Inhibitory Activity (tPDE4i)|tPDE4i was derived using in-vitro constants for protein binding and biochemical activity (IC50). An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Adverse Events of Interest (AEI) for PK analyses included: headache, diarrhea, nausea, vomiting, abdominal pain, appetite disorders, sleep disorders, angioedema, psychiatric disorders (anxiety, nervousness), psychiatric disorders (depression,suicidal ideation,behaviour) and weight loss.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. Down-titration: Pre-dose and 1,2,3,4,6 hours post-dose at Days 1 and 14 and pre-dose at Days 28 and 56.|"PK Set included all participants who had at least 1 quantifiable PK concentration. n in the category is the number of participants with available data. Study design only includes the 250 µg OD and 500 µg OD arms for analyses of this outcome measure. Measured values are predicted values reported as median and 90% prediction interval."|||unitless||90% Confidence Interval|Median
1326309|NCT02165826|Secondary|Total PDE4 Inhibitory Activity (tPDE4i)|tPDE4i was derived using in-vitro constants for protein binding and biochemical activity (IC50). tPDE4i is reported for a set of reference participants defined according to the covariates included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. Down-titration: Pre-dose and 1,2,3,4,6 hours post-dose at Days 1 and 14 and pre-dose at Days 28 and 56.|Participants from the PK Set, all participants who had at least 1 quantifiable PK concentration, with data available. Study design only includes the 250 µg arm for analyses of this outcome measure in the Down-Titration period. Measured values are predicted values reported as median and 90% prediction interval.|||unitless||90% Confidence Interval|Median
1326355|NCT02164929|Secondary|Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)|Complications using a Modified Postoperative Morbidity Survey (MPMS)|Participants will be followed for the duration of hospital stay, an estimated 1 week|Data not collected||||||
1326356|NCT02164929|Secondary|Quality of Recovery|Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.|72 hours||||Units on a scale||Standard Deviation|Mean
1326311|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Central Volume (Vc/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Vc/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||liters (L)|||Number
1326312|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Oral Clearance (CL/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for CL/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||liters per hour (L/h)|||Number
1326313|NCT02165826|Secondary|Population PK Model Point Estimate for Absorption Rate Constant (Ka) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Ka are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||units per hour (1/h)|||Number
1326314|NCT02165826|Secondary|Change From Baseline in Treatment Satisfaction Scores During the Down-Titration Period|Participants will be asked to assess their satisfaction with their COPD therapy at each visit. The participants will rate their treatment satisfaction on a 7-point scale where 0=very satisfied, 1=satisfied, 2=somewhat satisfied, 3=neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5=dissatisfied and 6=very dissatisfied. A negative change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|"Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1326315|NCT02165826|Secondary|Change From Baseline in Treatment Satisfaction Scores During the Main Period|Participants will be asked to assess their satisfaction with their COPD therapy at each visit. The participants will rate their treatment satisfaction on a 7-point scale where 0=very satisfied, 1=satisfied, 2=somewhat satisfied, 3=neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5=dissatisfied and 6=very dissatisfied. A negative change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
1326316|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) During the Down-Titration Period|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication.|||Liters||Standard Deviation|Mean
1326317|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) During the Main Period|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||Liters||Standard Deviation|Mean
1326318|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) During the Main Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||Liters||Standard Deviation|Mean
1326319|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) During the Down-Titration Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|"Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication. n in each category is the number of participants with data available at the given time-point."|||Liters||Standard Deviation|Mean
1326320|NCT02165826|Secondary|Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason During Down-Titration Period||Baseline DT (Day 1 of Down-Titration Period) to Week 8 (Down-Titration Period)|Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication.|||percentage of participants|||Number
1326357|NCT02164929|Secondary|Pain Scores|"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated."|Participants will be followed for the duration of hospital stay, an estimated 1 week||||Units on a scale||Standard Deviation|Mean
1326321|NCT02165826|Secondary|Change From Baseline (V0DT) in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) to Final Visit of the Down-Titration Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication A positive change from Baseline indicates improvement.|Baseline (V0DT) [assessment at end of main period] and Final Visit of Down-Titration Period (Up to Day 56)|Participants from the Down-Titration Period Full Analysis Set (FAS), all randomized participants who entered this period, regardless of whether they took study medication, with data available for analysis.|||Liters||Standard Deviation|Mean
1326322|NCT02165826|Secondary|Percentage of Participants With Adverse Events of Interest|Adverse events of interest to evaluate tolerability are defined as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain.|Baseline to Week 12 (Main Period)|SAS included all randomized participants who took at least one dose of study medication.|||percentage of participants|||Number
1326323|NCT02165826|Primary|Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason|The primary endpoint is the percentage of participants prematurely discontinuing study treatment for any reason during the Main Period from Visit 1 (V1) to Last Visit (Vend). Discontinuation is defined as permanently stopping randomized treatment; participants who resume randomized treatment after an interval will not be counted as having discontinued. The analysis used discontinuations occurring during the Main Period, irrespective of whether a participant subsequently entered into the Down-Titration Period.|Baseline to Week 12 (Main Period)|Safety Analysis Set (SAS) included all randomized participants who took at least one dose of study medication.|||percentage of participants|||Number
1326324|NCT02165761|Primary|Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points|Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.|14 days after index procedure|"In the GORE® Hybrid Vascular Graft Group 19 out of 23 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis.~In the Non-heparin bonded synthetic graft Group 16 out of 19 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis."|||Participants|||Count of Participants
1326325|NCT02165722|Primary|Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age|Change in cumulative vaccination rates from baseline to end of year 1 for HPV series completion (e.g., receipt of third dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.|Baseline period to post-intervention||||percent change in vaccination rates|||Number
1326326|NCT02165722|Primary|Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age|Change in cumulative vaccination rates from baseline to end of year 1 for HPV series initiation (e.g., receipt of first dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.|Baseline period to post-intervention|HPV series initiation stratified by age of 11-13 years and 14-17 years of age. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.|||percent change in vaccination rates|||Number
1326327|NCT02165462|Secondary|Age of Patients With Haemophilia||Screening visit||||years||Standard Deviation|Mean
1326328|NCT02165462|Secondary|Body Mass Index of Patients With Haemophilia|The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit||||kg/m2||Standard Deviation|Mean
1326329|NCT02165462|Secondary|Height of the Patients With Haemophilia|The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit||||cm||Standard Deviation|Mean
1326330|NCT02165462|Secondary|Joint Bleeding Before the Assessment||Screening visit||||participants|||Number
1326331|NCT02165462|Secondary|Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)|Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).|Screening visit||||participants|||Number
1326332|NCT02165462|Secondary|Weight of the Patients With Haemophilia|The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)|Screening visit||||Kg||Standard Deviation|Mean
1326333|NCT02165462|Primary|Assessment of Maximal Velocity of Movement|Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum speed (Vmax) was calculated as the maximum value of the first integral of the force-time curve for bilateral contractions, left-sided and right-sided|||m/s||Standard Deviation|Mean
1326334|NCT02165462|Primary|Assessment of Rate of Development During the Acceleration Phase|Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit||||N/s||Standard Deviation|Mean
1326335|NCT02165462|Primary|Change of Joint Condition Based on Clinical Assessment|"Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage).~The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4)"|Screening visit||||Units on a scale (range 0-24)||Standard Deviation|Mean
1326336|NCT02165462|Primary|Assessment of Rate of Development During the Preparation Phase|Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit||||N/s||Standard Deviation|Mean
1326337|NCT02165462|Primary|Assessment of Maximal Peak Force|Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum peak force (MPF) is defined as the maximum achieved in the force-time curve during the dynamic test plantar flexion for both bilateral conditions as right and left unilateral, normalized to body weight of the participants (N / kg value)|||N/kg||Standard Deviation|Mean
1326358|NCT02164929|Primary|Postoperative Opioid Consumption|If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.|24 hours after surgery||||mcg||Standard Deviation|Mean
1326338|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Acceleration Phase|Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"|||percentage||Standard Deviation|Mean
1326339|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Preparation Phase|Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the preparation phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"|||percentage||Standard Deviation|Mean
1326340|NCT02165462|Primary|Assessment of Bilateral Index of Maximal Peak Force|Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).|Screening visit|"Bilateral rates was calculated during the preparation phase and during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions. Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"|||percentage||Standard Deviation|Mean
1326341|NCT02165202|Primary|Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase|Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US.|Up to 52 weeks|Participants who received at least one injection and were followed up to 52 weeks are included in this analysis.|||Participants|||Count of Participants
1326342|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the VAS for Pain.|A secondary outcome of this study is pain as measured by the validated visual-analog scale (VAS) for pain. The VAS pain instrument measures pain on a scale from 0 cm (no pain) to 10 cm (extreme pain)|Measured at one month post-injection.||||centimeters measured on a visual scale||Standard Deviation|Mean
1326343|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.|A secondary outcome of this study is the patient-reported sensitivity to coldness as measured by the McCabe Cold Sensitivity score. Patients' answers on this validated instrument are scored on a scale from 0 (no sensitivity) to 400 (extreme sensitivity), where a higher number represents a worse outcome.|Measured at one month post-injection.||||Units on a scale||Standard Deviation|Mean
1326344|NCT02165111|Secondary|Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.|A secondary outcome of this study is severity of Raynaud's symptoms as measured by the self-reported Quick-DASH score. The Quick-DASH scores measures the degree of hand and upper extremity function on a scale of 0 (not limited) to 100 (severely limited) where a higher value represents a worse outcome.|Measured at one month post-injection.||||Units on a scale||Standard Deviation|Mean
1326345|NCT02165111|Secondary|Number of Ulcers as Measure of Digital Ulcer Healing|A secondary outcome of this study is the number of digital ulcers as determined by clinical examination. Mean number of ulcers was calculated as total number of ulcers / total number of hands in each group.|Measured at one month post-injection.||||Number of ulcers||Standard Deviation|Mean
1326346|NCT02165111|Secondary|Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.|"Raynaud's Condition Score is a patient-reported, validated outcomes scale that measures the severity of Raynaud's phenomenon on a scale of 0 (No difficulty) to 10 (Extreme difficulty), where higher values represent a worse outcome.~Data from each weekly report were combined using a statistical model (generalized linear population-average model) to calculate a weekly rate of change for each participant's hand, where a negative value represents a improvement over time and a positive value represents worsening over time."|Weekly rate of change over the four-month study period.||||change in RCS/week||95% Confidence Interval|Mean
1326347|NCT02165111|Primary|Change in Digital Blood Flow From Pre- to Post-injection.|The primary outcome measure is change in blood flow to the fingers, from a pre-injection baseline to post-injection follow-up visit as measured by non-invasive laser Doppler imaging.|Measured pre-injection and at one month post-injection.||||Blood flow, measured in LDI flux units,||95% Confidence Interval|Mean
1326348|NCT02165072|Primary|Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters.|Day 1 of ICU admission||||Percent change||Standard Deviation|Mean
1326349|NCT02165072|Primary|Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury.|Day 1 of ICU admission||||cm||Standard Deviation|Mean
1326350|NCT02164929|Secondary|Length of Stay||Participants will be followed for the duration of hospital stay, an estimated 1 week||||Days||Standard Deviation|Mean
1326351|NCT02164929|Secondary|Number of Epidural-related Side Effects||Participants will be followed for the duration of hospital stay, an estimated 1 week||||Number of side effects|||Number
1326352|NCT02164929|Secondary|Time to First Ingestion of Solid Food||Participants will be followed for the duration of hospital stay, an estimated 1 week||||Days||Standard Deviation|Mean
1326353|NCT02164929|Secondary|Opioid Related Side Effects|Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.|Participants will be followed for the duration of hospital stay, an estimated 1 week||||side effects|||Number
1326354|NCT02164929|Secondary|Time to First Bowel Movement||Participants will be followed for the duration of hospital stay, an estimated 1 week||||days||Standard Deviation|Mean
1326359|NCT02164916|Other Pre-specified|Overall Response Rate in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years from randomization|Eligible and analyzable patients with measurable disease.|||Participants|||Count of Participants
1326360|NCT02164916|Other Pre-specified|Overall Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years from randomization|Eligible and analyzable patients|||months||95% Confidence Interval|Median
1326361|NCT02164916|Other Pre-specified|Progression-free Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|From date of Step 3 Crossover registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.|Up to 3 years from randomization|All eligible and analyzable patients.|||months||95% Confidence Interval|Median
1326362|NCT02164916|Other Pre-specified|Overall Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years from randomization|All eligible and analyzable patients with measurable disease.|||Participants|||Count of Participants
1326363|NCT02164916|Other Pre-specified|Overall Survival|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years from randomization|Eligible and analyzable patients|||months||95% Confidence Interval|Median
1326364|NCT02164916|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
1326365|NCT02164916|Primary|Progression-free Survival|From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.|Up to 3 years from randomization|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
1326366|NCT02164864|Secondary|Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG|Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326367|NCT02164864|Secondary|Time to First Adjudicated Unplanned Revascularisation by PCI/CABG|Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326368|NCT02164864|Secondary|Time to Composite Endpoint of Death or First Thrombotic Event|Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326369|NCT02164864|Secondary|Time to Composite Endpoint of Death + MI + Stroke|Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326370|NCT02164864|Secondary|Time to First Adjudicated ST|Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326371|NCT02164864|Secondary|Time to First Adjudicated SE|"Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.~SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326374|NCT02164864|Secondary|Time to Adjudicated All Cause Death|Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326375|NCT02164864|Secondary|Time to Adjudicated CV|"Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.~CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326376|NCT02164864|Secondary|Time to Adjudicated Non-CV|"Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.~Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV"|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326377|NCT02164864|Secondary|Time to Adjudicated Undetermined Cause of Death|"Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.~This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was “patient died”) or when there was insufficient supporting information or detail to assign the cause of death."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326378|NCT02164864|Primary|Time to First Adjudicated ISTH MBE or CRNMBE|"Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.~Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.~Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.~Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
1326379|NCT02164539|Secondary|Change in Clinic FEV1 Following 2 Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment Dose at Visit 5/Day 28|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Reversibility was measured at Visit 1 and Visit 2 for study eligibility by change in clinic FEV1 within 20 to 60 minutes following 4 inhalations of albuterol/salbutamol and again measured 3 hours after dosing at Visit 5 by change in clinic FEV1 30 minutes following 2 inhalations of albuterol/salbutamol. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-albuterol/salbutamol FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
1326380|NCT02164539|Secondary|Change From Trough in Clinic Forced Expiratory Volume (FEV1) at 3 Hours Post-study Treatment at Visit 5/Day 28|FEV1 was measured in the morning by spirometry. At Visit 5, after trough FEV1 is measured, subject received investigational product. 3 hours post-dose, spirometry was repeated and subject then received 2 puffs of albuterol/salbutamol. After 30 minutes,spirometry was repeated.. Change from Baseline in clinic trough (pre-dose) FEV1 is the difference in the trough value at 3 hours post-dose peak FEV1 and the Baseline value. If the trough value or the Baseline was missing, then change from Baseline was considered as missing. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis done using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-dose trough FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
1326381|NCT02164539|Secondary|Change From Baseline in Daily Morning (AM) PEF (Pre-dose and Pre-rescue Bronchodilator) Measured at Home and Averaged Over the Last 21 Days of Treatment Phase A|Peak expiratory flow (PEF) stability limit was calculated from AM PEF measurements on the 7 days preceding Visit 3 as mean AM PEF from the available 7 days preceding Visit 3 x 80%. PEF stability limit serves as a benchmark of the participants run-in COPD status and used for comparison during the treatment phase to assess subject safety. Change from Baseline over the last 21 days of Treatment Phase A is the difference between the last 21 days of Treatment Phase A and the appropriate Baseline week. The last 21 days of Treatment Phase A include the AM assessments on the date of Visit 6. AM assessments include the date of Visit 6 and the 20 consecutive days preceding the date of Visit. Analysis performed using analysis of covariance with covariates of treatment, age, sex, Baseline AM PEF, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and from Day 8 through Day 29|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters per minute (L/min)||Standard Error|Least Squares Mean
1326382|NCT02164539|Secondary|Mean Change From Baseline in E-RS Total Scores at the End of Treatment Phase A|A daily symptoms score for exacerbations of chronic pulmonary disease tool - Respiratory Symptoms (E-RS) is derived by summing the 11 item-level E-RS scores and has a theoretical range of 0-40, with higher values indicating more severe respiratory symptoms. The Baseline E-RS score is defined as the mean within-subject daily score over the 7 days prior to randomization, with data present for a minimum of 4 of the 7 days. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate Baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline score, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1326383|NCT02164539|Secondary|Mean Change From Baseline in Rescue Medication Use at the End of Treatment Phase A|All participants received the albuterol/salbutamol via MDI as a rescue medication on an as-needed basis. Total daily rescue medication use for a given day is the sum of daytime albuterol/salbutamol use recorded in PM and nighttime albuterol/salbutamol use recorded in AM the next day. The number of puffs of albuterol (salbutamol) MDI used in the last 12 hours for relief of symptoms were recorded morning and evening in the eDiary by the participants. End of Treatment Phase A is the last 7 days of Treatment Phase A. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline rescue medication use, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.|||Puffs||Standard Error|Least Squares Mean
1326384|NCT02164539|Primary|Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29)|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 value obtained at Visit 6, approximately 24 hours after morning dosing on Visit 5. ITT population is comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and Day 29|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters||Standard Deviation|Mean
1326385|NCT02164396|Primary|Lid-Parallel Conjunctival Folds (LIPCOF)|LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade).|Baseline, 2-, 4-, 8- and 12-Week Follow-up|The analysis population consists of all subjects that completed the study without a major protocol deviation.|||Score|observations|Standard Deviation|Mean
1326386|NCT02164318|Secondary|Count of Participants Using Their AVF for Dialysis|Successful use of AVF at 12 months in dialysis dependent patients. Not relevant in participants that are predialysis or that discontinue dialysis prior to AVF use.|12 months post surgery|Only subjects who were on dialysis at 12 months are included in the analysis. Only 5 participants were on dialysis at this time.|||Participants|||Count of Participants
1326387|NCT02164318|Secondary|Count of Participants With a Patent Fistula|Determination that AVF is patent (has blood flow, no occlusion).|3 months post surgery|Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.|||Participants|||Count of Participants
1326388|NCT02164318|Primary|Count of Participants With Mature Arteriovenous Fistula (AVF)|Use of AVF for dialysis for dialysis dependent participants, or fistula deemed mature based on physical exam in predialysis participants (diameter >6 mm, blood flow >600 ml by ultrasound or estimated by physical exam).|3 month post surgery to create AVF|Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.|||Participants|||Count of Participants
1326389|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
1326390|NCT02163915|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
1326391|NCT02163915|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||hours||Full Range|Median
1327930|NCT02134184|Other Pre-specified|To Compare the T- and B-cell Response to Licensed IM TIV in Elderly Individuals Dependent on the Presence and Duration of CMV Infection by Analyses of Vaccine-induced Plasmablasts, Antibodies and Antigen-specific T Cells||Day 0 to Day 28|||||||
1326392|NCT02163915|Secondary|Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137|Maximum observed steady-state plasma concentration during a dosing interval.|Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||ng/mL||Standard Deviation|Mean
1326393|NCT02163915|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1326394|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
1326395|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
1326396|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
1326397|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
1326398|NCT02163915|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 up to Day 14|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
1326399|NCT02163733|Secondary|t1/2 of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of the terminal half-life.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||h||Full Range|Geometric Mean
1326400|NCT02163733|Secondary|Tmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of time to Cmax.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||h||Full Range|Median
1326401|NCT02163733|Secondary|AUC(0-120) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 120 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM*h||Full Range|Geometric Mean
1326402|NCT02163733|Secondary|AUC(0-t) of AZ5104 and AZ7550|Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291).|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM*h||Full Range|Geometric Mean
1326403|NCT02163733|Secondary|Cmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM||Full Range|Geometric Mean
1326404|NCT02163733|Secondary|AUC(0-72) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM*h||Full Range|Geometric Mean
1326752|NCT02155985|Secondary|Change in Expression of CD14dimCD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD14dimCD16+||95% Confidence Interval|Mean
1326405|NCT02163733|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||L||Full Range|Geometric Mean
1326406|NCT02163733|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||L/h||Full Range|Geometric Mean
1326407|NCT02163733|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||h||Full Range|Geometric Mean
1326408|NCT02163733|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||h||Full Range|Median
1326409|NCT02163733|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
1326410|NCT02163733|Secondary|AUC(0-t) of AZD9291|Area under the plasma concentration curve from time zero to last quantifiable dose.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
1326411|NCT02163733|Secondary|AUC of AZD9291|Area under the plasma concentration curve from zero extrapolated to infinity.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
1326412|NCT02163733|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients had at least 1 dose AZD9291 and had sufficient postdose PK to determine parameter without important protocol deviations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax). Note 1 patient missing key 8 hour sample so not included in Cmax analysis.|||nM||Full Range|Geometric Mean
1326413|NCT02163733|Primary|AUC(0-72) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
1326414|NCT02163538|Secondary|Time Required to Complete Procedure||End of surgery up to 4 hours||||Minutes||Inter-Quartile Range|Median
1326415|NCT02163538|Secondary|Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.||During procedure||||minutes||Inter-Quartile Range|Median
1326416|NCT02163538|Secondary|Need for Second Energy Device Intra-operatively||18 months||||Participants|||Count of Participants
1326417|NCT02163538|Secondary|Estimated Blood Loss||18 months||||mL||Inter-Quartile Range|Median
1326418|NCT02163538|Secondary|Intra- and Post-operative Complications||18 months||||Participants|||Count of Participants
1326419|NCT02163538|Primary|Raw Task Load Index (TLX) Score Assigned by Surgeons|"The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding.~Mental Demand Physical Demand Temporal Demand Performance Effort Frustration"|18 months||||units on a scale||Inter-Quartile Range|Median
1326585|NCT02158975|Secondary|Duration of Response|Time from documentation of tumor response to disease progression.|24 months after initiation of study treatment|Although 12 patients were analyzable, only one patient responded to treatment and therefore only 1 patient is represented for the duration of response.|||months|||Number
1326420|NCT02163499|Primary|Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365|Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population|Study Days 85 to 365|"The Extended Phase Intent To Treat populations (EP-ITT) included subjects who received at least one dose of ZS in the EP and have at least one S-K assessment after administration of Extended Phase ZS.~Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases."|||Percentage of participants||95% Confidence Interval|Number
1326421|NCT02163499|Primary|Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase|Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population|72 Hours|"The Intent To Treat populations for the Acute Phase (AP-ITT) included subjects who received at least one dose of ZS with at least one S-K assessment after administration of Acute Phase ZS.~Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases."|||Percentage of participants||95% Confidence Interval|Number
1326422|NCT02163499|Secondary|Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.|Mean S-K levels months 3 to 12(EP Days 85, 113, 141, 176, 211, 239, 267, 295, 330, 365 and EOS),months 6 to 9, and months 9 to 12.|Study days 85 to 365|Extended phase ITT population|||mmol/L||Standard Deviation|Mean
1326423|NCT02163499|Secondary|Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12|Proportion of Subjects with mean S-K between 3.5 and 5.5 mmol/L during Extended Dosing Phase - ITT Population|Study Days 85 to 365|Extended phase ITT population|||Proportion of participants||95% Confidence Interval|Number
1326424|NCT02163421|Primary|Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration|Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis.|Day 1: predose and on multiple time points (up to Day 127)|The pharmacokinetic analysis set included all randomized participants who received study treatment and who had at least 1 measurable pharmacokinetic concentration.|||percentage of drug||95% Confidence Interval|Number
1326425|NCT02163395|Secondary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at Week 26, Month 24 and Month 36|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.|||percentage of participants||95% Confidence Interval|Number
1326426|NCT02163395|Secondary|Mean Bone Level Changes (Distal and Mesial)|A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.|Measured at Week 26, Month 12, Month 24 and Month 36|Standardised bone level measurements provided for the ITT population. Missing data were not imputed.|||mm||Standard Deviation|Mean
1326427|NCT02163395|Secondary|The Implant Success|"According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply.~Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics)~Absence of implant mobility on manual palpation~Absence of any continuous peri-implant radiolucency"|Measured at Week 26, Month 12, Month 24 and Month 36|Implant success rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.|||percentage of participants||95% Confidence Interval|Number
1326428|NCT02163395|Primary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at 12 months +/- 4 weeks after implant placement|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.|||percentage of participants||95% Confidence Interval|Number
1326429|NCT02163187|Secondary|Quality of Life|QOL and urinary continence will be assessed at the start of the study (Baseline), after initial stimulation (Step 1-Wire Stimulation), and at each point in the crossover trial (Step 2-Implantation and Step 3-Crossover). Graphical displays will be used to explore data distributions of all secondary outcome measures over time. We assume no period effect and will evaluate the treatment effect using the paired t-test (and a repeated measures ANOVA to include other covariates in the model) for each of our main outcome measures, EuroQOL5, FIQOL, LARS and Bladder function. We will test for period effect to confirm this.|3 years|Study terminated early due to low accrual. Data were not collected.||||||
1326430|NCT02163187|Primary|Change in Bowel Function|Bowel function will be assessed by using the MSK BFI. We have chosen the BFI because it is widely endorsed to assess the clinical problem that these patients have. The BFI is a 19 item instrument to which a patient responds using a 5-point Likert scale, ranging from Always to Never.|3 years|Study terminated early due to low accrual. Data were not collected.||||||
1326431|NCT02162979|Secondary|Change in Dose of Anti-parkinsonian Medications||7 weeks|||||||
1326432|NCT02162979|Secondary|"Percent Change in on Time"|"on time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change."|4 weeks|||||||
1326433|NCT02162979|Primary|Change in Duration of Dyskinesia.||2 weeks|||||||
1326434|NCT02162862|Primary|Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm|PSQI score range is 0-21 with higher score indicating greater sleep disturbance.|Baseline (week 0) to end of study (week 14)||||units on a scale||Standard Deviation|Mean
1326435|NCT02162862|Primary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm|MFI score range is 0-100. Higher score indicates higher level of fatigue.|Baseline (week 0) to end of study (week 14)||||units on a scale||Standard Deviation|Mean
1327931|NCT02134184|Secondary|Number of Participants With Related Adverse Events||Day 0 to Day 28||||Participants|||Count of Participants
1326436|NCT02162758|Secondary|Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score|The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).|Baseline and Month 12|The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||units on scale||Standard Deviation|Mean
1326437|NCT02162758|Secondary|Percentage of Participants With Erosive Esophagitis (EE)|The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.|Baseline up to Month 12|The ITT population where EE assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||percentage of participants|||Number
1326438|NCT02162758|Secondary|Percentage of Participants With Recurrence of IM With Dysplasia|Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.|Month 12|The ITT population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||percentage of participants|||Number
1326439|NCT02162758|Primary|Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)|Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.|Month 12|The Intent-to-treat (ITT) population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||percentage of participants|||Number
1326440|NCT02162680|Primary|Differences in Patients' Perceptions of Pain Between Treatment Methods|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.|at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute||||units on a scale||Standard Deviation|Mean
1326441|NCT02162576|Secondary|Percent Change in the Proportion of Participants With Well-controlled Asthma|Daily control status was assessed based upon the timing and frequency of SABA actuations according to NAEPP guidelines. The proportion of the study cohort defined as well controlled, not well controlled and poorly controlled was assessed weekly throughout the program.|Baseline and study exit (approximately 13 months)||||percent change|||Number
1326442|NCT02162576|Secondary|Percent Change in the Proportion of Participants With an Asthma-free Day|Each 24-hour period without an actuation of a rescue inhaler was counted as an asthma-free day. The proportion of participants with an asthma-free day was calculated for each day of the program, with the denominator including all active participants on that day of the program, defined as those that synced after that date.|Change from baseline period to study exit (approximately 13 months)||||percentage change|||Number
1326443|NCT02162576|Primary|Change in Rescue Inhaler Actuations/Person/Day|The Propeller Health sensor permits the capture of objective time and location data on each actuation of the rescue inhaler. The mean number of rescue inhaler events per participant per day will be assessed for each day in the study, and the difference between the baseline month and all subsequent months will be evaluated.|Change from baseline to study exit, up to 13 months||||puffs per participant per day||Standard Deviation|Mean
1326444|NCT02161757|Secondary|Number of Patients Positive for Anti-drug Antibodies (ADAs)|ADA assessments performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for neutralising antibodies (nAb). ADA prevalence defined as proportion of study population with drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) defined as sum of treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive defined as having ≥1 post-baseline ADA positive assessment and not fulfilling conditions of persistently positive. Treatment-boosted ADA defined as baseline positive ADA titer boosted to a 4-fold or higher level following drug administration. In some category titles 'positive' is denoted by 'pos'.|Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)|The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
1326445|NCT02161757|Secondary|Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72|To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.|Blood samples were collected pre-dose at Baseline (Week 0), and at Week 4, Week 8, Week 26, Week 52 and Week 72 (follow-up)|All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients with data available at the timepoints of testing were included in the analysis.|||micrograms/millilitre||Geometric Coefficient of Variation|Geometric Mean
1326586|NCT02158975|Secondary|Median Overall Survival Time|Overall Survival (OS) is defined as the time from study start until death.|24 months after initiation of study treatment|Five patients died between start of treatment and database lock. Patients who were alive at the time of the database lock (March 31st, 2017) were administratively censored.|||months||95% Confidence Interval|Median
1327932|NCT02134184|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to Day 28||||Participants|||Count of Participants
1326446|NCT02161757|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of ‘since the last scheduled visit’. Total number of assessments was calculated across all patients for the following healthcare encounter category:~• Spirometry."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Assessments|||Number
1326447|NCT02161757|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of ‘since the last scheduled visit’. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:~• Hospitalisations (hospitalisations, intensive care and/or general care)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Days|||Number
1326448|NCT02161757|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of ‘since the last scheduled visit’. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:~Ambulance transport,~Emergency room visits,~Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),~Home visits (home visit, physician and/or other healthcare professional),~Telephone calls (telephone calls to physician and/or nurse), and~Advanced pulmonary function test."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Encounters|||Number
1326449|NCT02161757|Secondary|WPAI+CIQ: Activity Impairment at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient’s ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient’s experience over the previous 7 days.~The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.~Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis.|||Percent Impairment||Standard Deviation|Mean
1326450|NCT02161757|Secondary|Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient’s ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient’s experience over the previous 7 days. The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.~Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).~Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/ (Q7+Q8)*100; Presenteeism = (Q9/10)*100).~Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis.|||Percent productivity loss||Standard Deviation|Mean
1326451|NCT02161757|Secondary|Number of Patients With ≥1 Asthma Exacerbation up to Week 52|The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
1326452|NCT02161757|Secondary|Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])|The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Percentage of nights with awakenings||Standard Deviation|Mean
1326453|NCT02161757|Secondary|Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52|Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||L/min||Standard Deviation|Mean
1326587|NCT02158975|Secondary|Median Progression Free Survival Time|Progression Free Survival (PFS) is defined as the time from study start until disease progression or death.|24 months after initiation of study treatment|5 of the 12 patients withdrew prior to progression and therefore progression free survival was censored at their time of withdraw.|||months||95% Confidence Interval|Median
1326454|NCT02161757|Secondary|Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)|Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Puffs/day||Standard Deviation|Mean
1326455|NCT02161757|Secondary|Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1326456|NCT02161757|Secondary|AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52|"The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).~AAER = Number of Exacerbations*365.25 / (Follow-up date – Date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
1326457|NCT02161757|Secondary|Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score|The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score >1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1326458|NCT02161757|Secondary|Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score|The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1326459|NCT02161757|Secondary|Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)|Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1326460|NCT02161757|Secondary|Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)|Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Percent change from baseline||Standard Deviation|Mean
1326588|NCT02158975|Secondary|Number Patients That Experience Adverse Events, Grades 3-5|To assess the safety and tolerability of MLN9708, the number of patients experiencing Adverse Events (AEs) greater than or equal to grade 3 will be recorded.|30 days after the last dose of study drug||||participants|||Number
1326461|NCT02161757|Primary|Annualised Asthma Exacerbation Rate (AAER) up to Week 52|"Asthma exacerbation was defined as a worsening of asthma that led to any of the following:~Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.~An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).~An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.~AAER = number of exacerbations*365.25 / (follow-up date – date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).~AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
1326462|NCT02161562|Secondary|The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from week 8 of initial dosing phase and week 8 of second dosing phase.|Week 8 of initial dosing phase and week 8 of second dosing phase|Only Groups A2 and B2 participants, who had UAS7 scores collected at week 8 of initial dosing period and week 8 of second dosing period, were analyzed.|||Participants|||Number
1326463|NCT02161562|Secondary|Change in Urticaria Activity Score Over 7 Days (UAS7) Between Baseline and End of Second Dosing Period|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7 days before Baseline and the last 7 days of the second dosing period.|7 days prior to Baseline visit, and last 7 days of second dosing period|Group A (n=178) and Group B (n=136) participants were considered for the analysis. Only Group A and Group B participants who had both baseline and week 44 UAS7 scores collected, were analyzed.|||score on a scale||Standard Deviation|Mean
1326464|NCT02161562|Secondary|The Change in Urticaria Activity Score Over 7 Days (UAS7) From Baseline to Week 24 in Group B Participants|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7-day period prior to Baseline visit and the last 7 days prior to the week 24 visit of initial dosing period. A negative change from baseline indicates improvement.|7 days prior to Baseline visit, and last 7 days prior to week 24 of the initial dosing period|Group B participants (n=136) were considered for the analysis. Only Group B participants, who had both baseline and week 24 UAS7 scores collected, were analyzed.|||score on a scale||Standard Deviation|Mean
1326465|NCT02161562|Secondary|Difference in Urticaria Activity Score Over 7 Days (UAS7) Between End of Initial Dosing Period and the End of the Second Dosing Period, in Group B3 Participants Who Did Not Respond to the Initial Dosing Period|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the initial dosing period and the last 7 days of the second dosing period. A negative change indicates improvement.|last 7 days of initial dosing period, week 24, and last 7 days of second dosing period, week 36|Group B3 participants (n=43) were considered for the analysis. Only B3 participants, who had UAS7 scores collected at both weeks 24 and 44, were included in the analysis.|||score on a scale||Standard Deviation|Mean
1326466|NCT02161562|Secondary|Time to Relapse (Urticaria Activity Score Over 7 Days (UAS7) ≥ 16) After Drug Withdrawal in Participants Who Responded to Initial Dosing Period (Retreatment A2 and B2)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the time between end of initial dosing period to first occurence of UAS7 ≥ 16 will be evaluated.|study drug withdrawal period, weeks 24 through 32|The Retreatment participants were analyzed (A2=12, B2=44).|||Weeks||Standard Deviation|Mean
1326467|NCT02161562|Secondary|Number of Participants With Urticaria Activity Score Over 7 Days (UAS7)≤6 at the End of the Second Dosing Period, in Participants Who Stepped-up Treatment Dosing (Step-up A3)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.|Last 7 days of the second dosing period|Group A3 participants (n=141) were considered for the analysis. Only Group A3 participants, who had UAS7 scores collected at the end of the second dosing period, were analyzed.|||Participants|||Number
1326468|NCT02161562|Secondary|The Difference in Urticaria Activity Score Over 7 Days (UAS7) Between the Start and End of the Second Dosing Period, in Participants That Step-up Treatment Dose During the Initial Dosing Period (Step-up A3)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7 days prior to the second dosing period, and the last 7 days of the second dosing period. A negative change indicates improvement.|7 days prior to start of second dosing period and last 7 days of Second Dosing Period|Group A3 participants (n=141) were considered for the analysis. Only Group A3 participants, who had UAS7 scores collected at the start and end of the second dosing period, were analyzed.|||score on a scale||Standard Deviation|Mean
1326728|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Day 89-90||||HOMA-IR value||Standard Deviation|Least Squares Mean
1326469|NCT02161562|Primary|Number of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.|Last 7 days of second dosing period, 44 weeks|Participants from groups A2 (n=12) and B2 (n=44) were considered for the analysis. Only Groups A2 and B2 participants, who had UAS7 scores collected at end of the second dosing period, were analyzed.|||Participants|||Number
1326470|NCT02161549|Primary|Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System|Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System|during colonoscopy procedure after cleansing with CleanUp System|the mean and standard deviation of the average score after cleansing the colon using the Motus CleanUp System|||units on a scale||Standard Deviation|Mean
1326471|NCT02161484|Other Pre-specified|Incidence of Complications (e.g. Frequency of Foot-drop).|Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, “Foot Drop”, allergic reaction will be recorded|48 hours after the start of the surgery||||Number of complications|||Number
1326472|NCT02161484|Secondary|Total Amount of Local Anesthetic in 48 Hours Post Operatively|Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)|48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
1326473|NCT02161484|Secondary|Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively||48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
1326474|NCT02161484|Secondary|Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively||48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
1326475|NCT02161484|Secondary|Amount of Oxycodone for the First 48 h Post Operatively|Including number of dose and mg).|48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
1326476|NCT02161484|Secondary|Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively||48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
1326477|NCT02161484|Primary|Numeric Rating Scale (NRS) Pain Assessment|Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.|48 hours after the start of surgery||||units on a scale||Standard Deviation|Mean
1326478|NCT02161484|Primary|Numeric Rating Scale (NRS) Pain Assessment|Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.|24 hours after the start of surgery||||units on a scale||Standard Deviation|Mean
1326479|NCT02161484|Primary|Numeric Rating Scale (NRS) Pain Assessment|Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.|6 hours after the start of surgery||||units on a scale||Standard Deviation|Mean
1326480|NCT02161146|Secondary|Conjunctival Hyperemia Score|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.|||score on a scale|Participants|Standard Deviation|Mean
1326481|NCT02161146|Primary|Ocular Itching Score|Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.|||score on a scale|Participants|Standard Deviation|Mean
1326482|NCT02161016|Other Pre-specified|Time to Full Weight-bearing|This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.|up to 24 months|||||||
1326483|NCT02161016|Secondary|CT Scan|A CT scan will be done at 6 months in order to assess bone fusion.|6 months|||||||
1326484|NCT02161016|Secondary|Foot Ankle Disability Index|The Foot Ankle Disability Index (FADI) is a self-report of function that assesses activities of daily living, with scores ranging from 0 to 100.|24 months|||||||
1326485|NCT02161016|Secondary|SF-36 Score|The SF-36 is a survey for health and well-being.|24 months|||||||
1326486|NCT02161016|Primary|AOFAS Foot-and-Ankle Score|The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.|24 months|||||||
1326540|NCT02159859|Primary|Mean Time to Cmax of Ertapenem in Hemodialysis Patients|Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||hours||Standard Deviation|Mean
1326487|NCT02160990|Secondary|Aggregate Satiation Symptom Score|"Postprandial fullness, nausea, bloating, and pain were measured 30 minutes after the liquid meal using 100 mm horizontal visual analog scales (VAS). The subscale scores could each range from none(0) to worst ever (100) at the left and right ends of the lines for each symptom. These satiation symptom scores (postprandial fullness, nausea, bloating, and pain) were combined to generate a total scale score with a different total scale range (0 - 400 mm) with 0 mm indicating none and 400 indicating worst ever."|Visit 3, approximately 30 min after ingestion of nutrient drink test||||mm||Inter-Quartile Range|Median
1326488|NCT02160990|Secondary|Buffet Meal Intake (kcal)|"Five hours after the standard egg meal ingested to measure gastric emptying, subjects were invited to eat, over a 30 minute period, a standard all you can eat meal. This meal consisted of either meat or vegetable lasagna, vanilla pudding, and skim milk. Personnel from the study team weighed the food servings post-meal and reported the amount of food left from single portions partially consumed. The total kcal of the food consumed was analyzed by using validated software."|"Visit 4, approximately 30 minutes after start of all you can eat meal"||||kcal||Inter-Quartile Range|Median
1326489|NCT02160990|Secondary|Maximum Tolerated Volume|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 5.|Visit 3, approximately 30 minutes after liquid meal||||mL||Inter-Quartile Range|Median
1326490|NCT02160990|Secondary|Satiation Expressed as Volume to Fullness|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Visit 3, approximately 30 minutes after liquid meal||||mL||Inter-Quartile Range|Median
1326491|NCT02160990|Secondary|Change in Body Weight||baseline, day 30||||kg||Inter-Quartile Range|Median
1326492|NCT02160990|Secondary|Percentage of Gastric Contents Emptied at 1 Hour|Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 1 hour.|Visit 4, approximately 1 hours after radiolabeled meal was ingested||||percentage of meal emptied||Inter-Quartile Range|Median
1326493|NCT02160990|Primary|Gastric Emptying Half-time (T 1/2) of Solids|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).|time frame is 30 days after the initiation of dose.||||minutes||Inter-Quartile Range|Median
1326494|NCT02160977|Secondary|VAS(Visual Analogue Scale/Score) of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a worse outcome|6 months||||units on a scale||Standard Deviation|Mean
1326495|NCT02160977|Secondary|HSS(Hospital for Special Surgery) Score of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a better outcome|6 months||||units on a scale||Standard Deviation|Mean
1326496|NCT02160977|Primary|Proprioception of the Knee Post Operation|"Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation.~Scale Name:degree scale range:0~180 degree,and a higher values represent a worse outcome"|six months||||units on a scale||Standard Error|Mean
1326497|NCT02160873|Secondary|Urine Volume|Measurement of total urine output.|24 hour||||mililiters||Standard Deviation|Mean
1326498|NCT02160873|Other Pre-specified|Exercise Metabolism|Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio|24 hours||||Respiratory exchange ratio||Standard Deviation|Mean
1326499|NCT02160873|Secondary|Urine Specific Gravity|Changes in urine specific gravity will be measured pre and post a 10K time trial run on a treadmill|24 hours||||Urine specific gravity||Standard Deviation|Mean
1326500|NCT02160873|Primary|Running Performance|10K time trial on a treadmill|24 hours||||minutes||Standard Deviation|Mean
1326501|NCT02160314|Primary|Treatment-emergent Serious Adverse Event|proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event|3 month|Intent-to-treat (ITT)|||participants|||Number
1326502|NCT02160145|Other Pre-specified|Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up|The mean change from baseline in urine specific gravity for the double-blind treatment period collection timepoints and post-treatment follow up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.|Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.|The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented.|||unitless||Standard Deviation|Mean
1326503|NCT02160145|Other Pre-specified|Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up|The mean change from baseline in urine osmolality for the double-blind treatment period collection timepoints and post-treatment follow-up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.|Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.|The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented.|||milliosmole per kilogram (mOSm/kg)||Standard Deviation|Mean
1326729|NCT02156271|Secondary|Interleukin 6 (IL-6)||Day 89-90||||pg/mL||Standard Deviation|Least Squares Mean
1326504|NCT02160145|Secondary|Mean Annualized Slope of eGFR Change|"To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula.~The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented."|Pretreatment baseline to post-treatment follow-up (up to 61 weeks).|The key secondary endpoint efficacy population consisted of all randomized subjects who took at least 1 dose of IMP after randomization, and have a baseline (average of up to 3 eGFR values observed during screening and placebo run-in periods) and at least 1 post-randomization evaluation in eGFR during the double-blind treatment period.|||mL/min/1.73m^2/year||Standard Error|Least Squares Mean
1326505|NCT02160145|Primary|The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.|"The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration.~The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods."|Pretreatment baseline to post-treatment follow-up (up to 61 weeks).|The primary endpoint efficacy population consisted of all subjects who were in the randomized sample, took at least 1 dose of investigational medicinal product (IMP) after randomization, and had a baseline and at least 1 valid post-treatment evaluation in eGFR (i.e at least 1 week off-treatment).|||mL/min/1.73 m^2/year||Standard Error|Least Squares Mean
1326506|NCT02160002|Post-Hoc|Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA)|Growth velocity in terms of weight (g/kg/day), considering infant weight at 24 hours after successful wean to crib and weight at 36 weeks postmenstrual age (PMA).|24 hours after successful wean to 36 weeks postmenstrual age (PMA)|257 infants (136 LW, 121 HW) remained in hospital at 36 weeks PMA w/ weight measured at 36 weeks PMA. 26 (10 LW, 16 HW) were still in incubator at 36 weeks PMA, 31 (16 LW, 15 HW) were missing weight after 24 hrs of successful wean, and 4 (LW) w/ weights measured at 24 hrs after successful wean were missing date of 24 hr weight after successful wean|||grams/kilograms/day||Standard Deviation|Mean
1326507|NCT02160002|Secondary|Length of Stay (LOS) Following Randomization to Hospital Discharge|The number of days the infant stayed in hospital after randomization to the study until discharge.|From randomization through discharge.|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have the date of discharge.|||days||Inter-Quartile Range|Median
1326508|NCT02160002|Secondary|Transferred to a Non-Network Hospital|Number of infants transferred to another non-Network hospital.|Status (discharge, death, transfer to another facility, or 120 days)|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.|||Participants|||Count of Participants
1326509|NCT02160002|Secondary|Death Among Enrolled Infants||Status (discharge, death, transfer to another facility, or 120 days)|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.|||Participants|||Count of Participants
1326510|NCT02160002|Secondary|Readmission to the Hospital Within 1 Week of Discharge|Number of infants re-hospitalized within 1 week (7 days) of discharge.|Discharge through 1 week after discharge.|174 infants in the Lower Weight group and 168 infants in the Higher Weight group had post discharge follow-up.|||Participants|||Count of Participants
1326511|NCT02160002|Secondary|Postmenstrual Age (PMA) at Discharge|Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge.|Discharge|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have postmenstrual age (PMA) at discharge data.|||weeks||Inter-Quartile Range|Median
1326512|NCT02160002|Secondary|Growth Parameters: Head Circumference at Status|Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.|Status (discharge, death, transfer to another facility, or 120 days)|182 infants in the Lower Weight group and 173 infants in the Higher Weight group have the head circumference at status data.|||centimeters||Standard Deviation|Mean
1326513|NCT02160002|Secondary|Growth Parameters: Length at Status|Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.|Status (discharge, death, transfer to another facility, or 120 days)|174 infants in the Lower Weight group and 169 infants in the Higher Weight group have the length at status data.|||centimeters||Standard Deviation|Mean
1326514|NCT02160002|Secondary|Growth Parameters: Weight at Status|Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.|Status (discharge, death, transfer to another facility, or 120 days)|185 infants in the Lower Weight group and 177 infants in the Higher Weight group had their weights recorded upon reaching status.|||grams||Standard Deviation|Mean
1326515|NCT02160002|Secondary|Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)|Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA).|Start of weaning from incubator through 36 weeks postmenstrual age (PMA)|There were 257 (136 LW and 121 HW) infants who remained in the hospital at 36 weeks PMA that have weights measured at 36 weeks PMA. Twenty six infants (10 LW and 16 HW) who were still in the incubator at 36 weeks PMA and 20 infants (7 LW and 13 HW) missing the date of start of weaning were excluded from the analysis.|||grams/kilograms/day||Standard Deviation|Mean
1326516|NCT02160002|Secondary|Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)|Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings.|Through completion of 2 weaning attempts|178 infants in the Lower Weight group and 167 infants in the Higher Weight group have the data on whether weaning from incubator to crib was successful after two attempts at weaning.|||Participants|||Count of Participants
1326582|NCT02159040|Secondary|Duration of Response|Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse per IWG 2006 criteria.|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326517|NCT02160002|Secondary|Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)|Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days).|From start of weaning from the incubator to crib through discharge (up to 120 days)|There were 163 infants in the Lower Weight group that were successfully weaned from incubator to the crib; discharge date was missing for one of these infants. There were 159 infants in the Higher Weight group that were successfully weaned from incubator to the crib; 4 infants were missing start of weaning dates because of protocol violations.|||days||Inter-Quartile Range|Median
1326518|NCT02160002|Primary|Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)|Number of days the infant stays in hospital after birth until discharge home (up to 120 days).|From birth through discharge|185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available.|||days||Inter-Quartile Range|Median
1326519|NCT02159950|Other Pre-specified|Effects of Tasquinimod on the Inhibition of Immune Cells||Up to week 50|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326520|NCT02159950|Secondary|Time to PSA Progression||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326521|NCT02159950|Secondary|Progression-free Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326522|NCT02159950|Secondary|Overall Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326523|NCT02159950|Secondary|Objective Response Rates (Partial or Complete)||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326524|NCT02159950|Secondary|Immune Response (Arm 2 Only)||Week 0|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326525|NCT02159950|Secondary|Immune Response||Week 50|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326526|NCT02159950|Secondary|Immune Response||Week 26|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326527|NCT02159950|Secondary|Immune Response||Week 10|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326528|NCT02159950|Secondary|Immune Response||Week 6|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326529|NCT02159950|Secondary|Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4|The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.|Up to 3 years|All treated and eligible patients.|||participants|||Number
1326530|NCT02159950|Secondary|Duration of PSA Response||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326531|NCT02159950|Secondary|Change in PSA Response|PSA doubling time, PSA slope|Baseline to up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326532|NCT02159950|Primary|Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024||Baseline up to 50 weeks|Due a Lack of funding data was not collected and no patients were analyzed.||||||
1326533|NCT02159898|Secondary|GERD-HRQL|"Evaluate symptoms of gastric reflux as assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument at 4 weeks following treatment.~Scale:~0 = No symptom~= Symptoms noticeable but not bothersome~= Symptoms noticeable and bothersome but not every day~= Symptoms bothersome every day~= Symptoms affect daily activity~= Symptoms are incapacitating to do daily activities"|4 Weeks Following Treament|Results at week 4, number of patients analyzed differs from baseline due to inability to continue to follow the patients due to death or lost to follow up.|||units on a scale||Standard Deviation|Mean
1326534|NCT02159898|Primary|Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment|"The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment.~Scale:~0 = able to eat normal diet / no dysphagia.~= able to swallow some solid foods~= able to swallow only semi solid foods~= able to swallow liquids only~= unable to swallow anything / total dysphagia"|2 Weeks Following Treatment|1 patient was randomized but not treated and other patients are not included|||units on a scale||Standard Deviation|Mean
1326535|NCT02159859|Other Pre-specified|Number of Participants With Any Adverse Events|Evaluation of any adverse events will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
1326536|NCT02159859|Secondary|Number of Participants With Injection Site Reaction|Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
1326537|NCT02159859|Secondary|Number of Participants With Headache|Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
1326538|NCT02159859|Secondary|Number of Participants With Nausea and Vomiting|Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
1326539|NCT02159859|Secondary|Number of Participants With Diarrhea|Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
1326583|NCT02159040|Secondary|Time to Response|Time to response is defined as time from the date of the first dose of study treatment to the date of the first documented hematologic improvement.|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326730|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Day 89-90||||ng/mL||Standard Deviation|Least Squares Mean
1326541|NCT02159859|Primary|Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients|Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||hours||Standard Deviation|Mean
1326542|NCT02159859|Primary|Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients|Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||h*ug/mL||Standard Deviation|Mean
1326543|NCT02159859|Primary|Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients|Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||mcg/ml||Standard Deviation|Mean
1326544|NCT02159859|Primary|Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients|Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||mcg/ml||Standard Deviation|Mean
1326545|NCT02159768|Secondary|Transmission of Airtraq View of Larynx|The view of the larynx will be captured by the handphone attached to the Airtraq layryngoscope, and then transmitted to a second investigator.|Intra operative measurement, time frame within 5 minutes|The larynx could be visualized in all 30 patients using the handphone attached to the Airtraq. The images of the larynx could be transmitted to a remote assistant in all 30 patients.|||participants|||Number
1326546|NCT02159768|Primary|Visualization of Larynx With the Airtraq Laryngoscope and Handphone|The efficacy of viewing the larynx via the handphone attached to the Airtraq laryngoscope will be assessed.|Intra operative|Study participants in whom the Airtraq handphone visualization system was studied|||participants|||Number
1326547|NCT02159547|Secondary|Adverse Effects|The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.|45th minutes||||participants|||Number
1326548|NCT02159547|Primary|Visual Analogue Scale Change|Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.|45 minutes||||units on a scale||95% Confidence Interval|Median
1326549|NCT02159482|Secondary|Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response|The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis.|4 weeks|Five subjects analysed due to one subject not completing blood draws.|||percentage of participants|||Number
1326550|NCT02159482|Primary|Proportion of Clinical Responders (Complete Response + Partial Response)|Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.|4 weeks||||percentage of participants|||Number
1326551|NCT02159469|Secondary|Safety and Tolerability|"Incidence of adverse events throughout the study~Incidence and severity of injection site reactions throughout the study"|52 weeks|TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.|||Participants|||Count of Participants
1326552|NCT02159469|Primary|Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)|The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.|12 weeks|The Population consisted of all patients who received at least 1 dose of the investigational product. Percentage was calculated using the number of patients in the column heading as the denominator.|||Participants|||Count of Participants
1326553|NCT02159365|Secondary|Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period|An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Date of first dose up to 60 days post last dose (approximately 4 years)||2018-08-31|08/2018||||
1326554|NCT02159365|Primary|Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2 at Primary Endpoint|Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|From Day 1 to End of cycle 2 treatment (approximately 56 days)|All Treated Participants|||participants||95% Confidence Interval|Number
1326584|NCT02159040|Primary|Overall Response Rate Per IWG 2006 Criteria|ORR (inclusive of CR, PR and HI) per IWG 2006 criteria including erythroid response, platelet response and neutrophil response over the course of one year. Hematologic improvement must be maintained for at least 8 weeks in order to count as HI.|1 year|Only one patient in trial. No analysis will ever be done.||||||
1326555|NCT02159352|Secondary|Number of Participants With Abnormalities in Urinalysis and Other Chemistry Testing Results|Criteria for marked abnormalities on laboratory test results: urinary dipstick blood: ≥2 if pretreatment (PreRx) <1, ≥2 if PreRx is missing or ≥2*PreRx if PreRx ≥1. Urinary microscopic red blood cell (RBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Urinary microscopic white blood cell (WBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Lactate dehydrogenase >1.25*upper limit of normal (ULN) if PreRx ≤ULN, >1.25*ULN if PreRx is missing and >1.5*PreRx if PreRx >ULN.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.|||participants|||Number
1326556|NCT02159352|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test Results|Criteria for marked abnormalities in test results: Platelet count >1.5*upper limits of normal (ULN) value, >1.5*ULN if pretreatment (PreRx) value is missing, <0.85*lower limit of normal (LLN) if PreRx ≥LLN, <0.85*LLN if PreRx is missing, <0.85*PreRx if PreRx <LLN. Leukocytes >1.2*ULN if LLN ≤PreRx ≤ULN, >1.2*ULN if PreRx is missing, >1.5*PreRx if PreRx >ULN, >ULN if PreRx <LLN, <0.85*PreRx if PreRx <LLN, <0.9*LLN if LLN ≤PreRx ≤ULN, <0.9*LLN if PreRx is missing and <LLN if PreRx >ULN. Lymphocytes >7.5*10^3 c/uL and <0.75*10^3 c/uL. Neutrophils <0.85*PreRx if PreRx <1.5*ULN, <1.5*ULN if PreRx ≥1.5*ULN and <1.5*ULN if PreRx is missing.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.|||participants|||Number
1326557|NCT02159352|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|Abnormalities in ECG findings included: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, and second- or third-degree heart block.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All participants who received at least 1 dose of study drug|||participants|||Number
1326558|NCT02159352|Secondary|Number of Participants With Abnormalities in Vital Sign Measurements|Criteria for abnormalities in vital sign measurements: Diastolic blood pressure: Value >90 and change from baseline > 0 or value < 55 and change from baseline <-10. Systolic blood pressure: Value >140 and change from baseline >20 or value <90 and change from baseline <-20. Heart rate: Value >100 and change from baseline >30 or value <55 and change from baseline <-15. Respiration: Value >16 or change from baseline >10. Temperature: Value >38.3°C or change from baseline >1.6°C.|From start of study treatment (Day 1) to study discharge (up to 15 days)|Participants who received at least 1 dose of study drug|||participants|||Number
1326559|NCT02159352|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (Day 1) to study discharge for AEs (up to 15 days); Day 1 to 30 days after last dose of study treatment for SAEs (up to 44 days)|All participants who received at least 1 dose of study drug|||participants|||Number
1326560|NCT02159352|Secondary|Dose-normalized Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]/D) of Daclatasvir|AUC(TAU)/D was obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1326561|NCT02159352|Secondary|Dose-normalized Maximum Observed Plasma Concentration (Cmax/D) and Dose-normalized Plasma Concentration Observed at 24 Hours Postdose (C24/D) of Daclatasvir|Cmax/D and C24/D are obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1326562|NCT02159352|Secondary|Plasma Concentration Observed at 24 Hours Postdose (C24) of Daclatasvir|C24 was obtained from concentration time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1326563|NCT02159352|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was obtained from concentration-time plot of daclatasvir by using non-compartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.|||hours||Full Range|Median
1326564|NCT02159352|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]) for Daclatasvir|AUC(TAU) was the area under the curve from time zero to end of dosing interval. AUC(TAU) was obtained from concentration-time plot of daclatasvir using noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles. Number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1326565|NCT02159352|Primary|Maximum Observed Plasma Concentration (Cmax) for Daclatasvir|Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1326566|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||seconds||Standard Deviation|Mean
1326567|NCT02159118|Secondary|Operator Satisfaction With Manual Device and Powered Device|Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.|Within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the requires sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||units on a scale||Standard Deviation|Mean
1326568|NCT02159118|Secondary|Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device|Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.|within 4 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||units on a scale||Standard Deviation|Mean
1326569|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||seconds||Standard Deviation|Mean
1326570|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device|number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||needle passes|Participants|Standard Deviation|Mean
1326571|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||mm3||Standard Deviation|Mean
1326572|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||mm||Standard Deviation|Mean
1326573|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||mm||Standard Deviation|Mean
1326574|NCT02159118|Primary|Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device|Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.|within 24 hours of bone marrow sampling procedure|All participants enrolled in the study were included in analysis, as the required sample size for the study was met. No subjects were excluded from analysis. Analysis was made per protocol.|||% Hematopoetic tissue present||Standard Deviation|Mean
1326575|NCT02159040|Secondary|Prevalence of MDS/AML Related Gene Mutations|Prevalence of the following mutations in the study population (TP53, EZH2, ETV6, RUNX1, ASXL1, other mutation that is present in ≥ 5% of patients)|Baseline|Only one patient in trial. No analysis will ever be done.||||||
1326576|NCT02159040|Secondary|Rate of Infection|Median number of infections (positive bacterial, viral or fungal culture, or infection requiring IV antimicrobial, or infection resulting in hospitalization or death) in patients treated with azacitidine alone vs. azacitidine + deferasirox|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326577|NCT02159040|Secondary|Incidence of Adverse Events|Incidence of adverse events (AEs) overall and by severity, and serious adverse events (SAEs).|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326578|NCT02159040|Secondary|Change in Serum Ferritin|Change in Serum Ferritin|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326579|NCT02159040|Secondary|Time to AML Transformation|Time to AML transformation is defined as time from the date of the first dose of study treatment to the date of the first documented bone marrow blast count ≥ 20% per WHO classification 1999.|Up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326580|NCT02159040|Secondary|Overall Survival|Overall survival is defined as time from the date of the first dose of study treatment to the date of death from any cause.|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326581|NCT02159040|Secondary|Progression Free Survival|Progression free survival is defined as time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse per IWG 2006 criteria.|Up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
1326589|NCT02158975|Primary|Objective Response Rate|The percentage of patients with an objective response rate will be determined. The overall response will be based on response in each compartment (skin, blood, lymph nodes and viscera) using a global composite scoring system. Objective response is considered (CR) Complete Response (Complete disappearance of all clinical evidence of disease), CRu (Complete Response Unconfirmed), or (PR) Partial Response (Regression of measurable disease).|Up to 24 months after initiation of study treatment|12 analyzable patients|||percentage of patients||95% Confidence Interval|Number
1326590|NCT02158936|Secondary|Cmax -Pharmacokinetic Parameter of Azacitidine|An analysis of variance (ANOVA) on Cmax . The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + ltrombopag:azacitidine + placebo PK parameter ratios.|Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose|All patients with evaluable azacitidine dosing, actual sampling time, and azacitidine concentration data were included in the NCA dataset and analysis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1326591|NCT02158936|Secondary|AUC0-infinity -Pharmacokinetic(s) Parameter of Azacitidine|An analysis of variance (ANOVA) on AUC0-infinity. The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + eltrombopag:azacitidine + placebo PK parameter ratios.|Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose|all patients with evaluable azacitidine dosing, actual sampling time, and azacitidine concentration data were included in the NCA dataset and analysis|||hr.ng/mL||Geometric Coefficient of Variation|Geometric Mean
1326592|NCT02158936|Secondary|Summary of Post-Hoc Estimates of Steady-state Eltrombopag AUC0 Infinity Pharmacokinetic Parameters for a 50 mg Dose|Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163)|Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose|All patients with evaluable eltrombopag dosing, actual sampling time, and eltrombopag concentration data were included in the population PK dataset and analysis.|||hr.μg/mL||Geometric Coefficient of Variation|Geometric Mean
1326593|NCT02158936|Secondary|Summary of Post-Hoc Estimates of Steady-state Eltrombopag Cmax and Cmin Pharmacokinetic Parameters for a 50 mg Dose|Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163)|Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose|All patients with evaluable eltrombopag dosing, actual sampling time, and eltrombopag concentration data were included in the population PK dataset and analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1326594|NCT02158936|Secondary|Medical Resource Utilization (MRU): Use of Site Specific Medical Resources|MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||visits|||Number
1326595|NCT02158936|Secondary|Medical Resource Utilization (MRU): Event and Use of Site Specific Medical Resources - Non-study Laboratory Tests|MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||tests|||Number
1326596|NCT02158936|Secondary|Medical Resource Utilization (MRU): Event -Hospitalizations Inpatient and Outpatient|MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||days||Standard Deviation|Mean
1326597|NCT02158936|Secondary|Functional Assessment of Chronic Disease Therapy-fatigue Subscale (FACIT-Fatigue) (ITT)|"The FACIT-Fatigue subscale measures severity and impact of fatigue on functioning and Health Related QoL experienced in the past 7 days. Scale is a 13 item measure of fatigure. Items are scored on a 0-4 response scale ranging from not at all to very much so. All items are summed to create a single fatigure score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatiigue (The FACIT Fatigue Scale is owned by David Cella, Ph.D.)"|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||scores||Standard Deviation|Mean
1326598|NCT02158936|Secondary|Response Levels in All Domains of Euroquol-5 Dimensions of Health, 3 Response Levels (EQ-5D-3L™)|The EQ-5D is a general health status and health utility measure which captures 5 dimensions of health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. (EQ-5D is a trademark of the Stichting EuroQol Group) . C=cycle, D=Day|From Day 1 to 4-week follow-up up to approximately 2 years||||participant|||Number
1326599|NCT02158936|Secondary|Number of of Subjects With Azacitidine Dose Delays, Dose Reductions, Interruptions|The proportion of subjects with any delay, reduction or interruption in dosage of Azacitidine excluding those for non-medical reasons will be analyzed|From Day 1 to 4-week follow-up up to approximately 2 years||||participant|||Number
1326600|NCT02158936|Secondary|Bleeding Adverse Events (AEs) >= Grade 3|Bleeding will be assessed by recording AEs or serious adverse events (SAEs) as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|From Day 1 to 4-week follow-up up to approximately 2 years||||participant|||Number
1326601|NCT02158936|Secondary|Number of Participants Who Were Platelet Transfusion Independent (ITT Set)|Platelet transfusion independence is defined for each cycle as the number of participants who continue to the end of a cycle without requiring a platelet transfusion|From Day 1 to end of study treatment up to approximately 2 years||||participants|||Number
1326602|NCT02158936|Secondary|Hematologic Improvement (HI) in Platelets, Neutrophils, and Hemoglobin Based on the Modified IWG Criteria for MDS (ITT)|HI based on the modified IWG criteria for MDS. HI – Platelets (BL <100Gi/L), response criteria= BL <20: increase to>20 and 100% at least for 56 days or BL >=20: absolute increase of >=30. HI – Neutrophils (BL <1.0 Gi/L), response criteria=100% increase and an absolute increase >0.5 Gi/L over BL for at least 56 days. HI-Hemoglobin (BL <g/dL), response criteria=Hgb increase by >=1.5 g/dL over BL, RBC transfusions(given for Hgb<=9.0) reduced by >=4 per 8w from BL|From Day 1 to 4-week follow-up (samples collected weekly in Cycle 1, Days 1 and 15 in Cycles 2-6 and Day 1 of Cycles >=7)||||participants|||Number
1326603|NCT02158936|Secondary|Best Disease Response From Central Review (ITT)|Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS|At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first||||participant|||Number
1326604|NCT02158936|Secondary|Best Disease Response From Investigator Assessment (ITT)|Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS|At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first||||participant|||Number
1326605|NCT02158936|Secondary|Summary of AML Progression From Investigator Assessment and Central Review (ITT)|"Progression to AML in MDS patients with baseline bone marrow blast < 20% was defined as meeting definition of disease progression according to the modified 2006 IWG response criteria for MDS with the additional requirement that bone marrow blast or peripheral blast increases from < 20% at baseline to ≥ 20% postbaseline. Progression assessment For patients with:~Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts"|First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years|The intent-to-treat (ITT) population included all the patients randomized in the study|||participants|||Number
1326606|NCT02158936|Secondary|Summary of Progression Free Survival From Central Review (ITT)|"Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with:~Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts"|First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years|The intent-to-treat (ITT) population included all the patients randomized in the study|||participants|||Number
1326607|NCT02158936|Secondary|Summary of Progression Free Survival From Investigator Assessment (ITT)|Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts|First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years|The intent-to-treat (ITT) population included all the patients randomized in the study|||participants|||Number
1326608|NCT02158936|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause and deaths have been presented. Subjects still alive at the time of the analysis and subjects who have withdrawn from the study will be censored at the time of last contact|Randomization until death or end of study, approximately 2 years||||deaths (events)|||Number
1326609|NCT02158936|Primary|Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy|A subject is defined as being platelet transfusion independent if they received no platelet transfusions within the first 4 cycles of treatment with azacitidine. Subjects who died or withdrew from investigational product within the first four cycles were treated as failures (i.e. not transfusion independent) in the analysis|4 cycles (Cycle = 28 days)|Intent-to-Treat population, comprised of all randomized patients|||Participants|||Number
1326610|NCT02158728|Primary|Number of Electrocardiograms (ECGs) Collected|Collected were the number of ECGs received from the enrolled subjects, the number of ECGs with SVT (supraventricular tachycardia) episodes, and the number of ECGs with SVT episodes qualified for algorithm development and validation of the potential new ICD. The ECG data were collected continuously during the indicated procedure (ICD/CRT-D implant, ICD/CRT-D change-out, electrophysiology (EP) study (including non invasive EP study)|After recorded ECGs had been received, which were collected until the end of the indicated procedure|Total number of ECGs received from the 80 enrolled subjects.|||ECG|||Number
1326611|NCT02158572|Other Pre-specified|Cycle Control|Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.|1 year|Subjects that reported BTB and/or BTS|||Episodes/cycle||Standard Deviation|Mean
1326612|NCT02158572|Other Pre-specified|Self-reported Patch Adhesion|"Patch adhesion was reported using the following 5-point scoring method:~0: ≥ 90% adhered (none to minimal lift)~≥ 75% adhered but < 90% (some edges showing lift)~≥ 50% adhered but < 75% (at least half of system lifts off)~< 50% (more than half of the patch lifts off, but the patch remains attached)~Patch completely detached."|1 year|Subjects that reported patch adhesion|||Score||Standard Deviation|Mean
1326613|NCT02158572|Other Pre-specified|Self-reported Skin Itching at Application Site|"Self-reported skin itching at application site was assessed using the following scoring method:~0: None~Mild~Moderate~Severe"|1 year|Subjects who reported itching at the application site|||Score||Standard Deviation|Mean
1326614|NCT02158572|Other Pre-specified|Self-reported Skin Irritation at Application Site|"Self-reported skin irritation at application site was assessed using the following scoring method:~0: None~Mild~Moderate~Severe"|1 year|Subjects who reported irritation at the application site.|||Score||Standard Deviation|Mean
1326627|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female|"Risk group is defined as the patients whose airway length from medial incisor to carina is below 23cm.~Conventional method : depth of intubation is 21cm at the medial incisor for female.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
1326615|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI , PPI|"Contraception efficacy measured by Pearl Index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.~PPI dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.~Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)"|1 year|PPI population|||Pearl Index||95% Confidence Interval|Number
1326616|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 30 kg/m2, Per-Protocol-Instructions (PPI) Dataset|"Contraception efficacy measured by Pearl Index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.~PPI Efficacy Dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.~Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)"|1 year|PPI population|||Pearl Index||95% Confidence Interval|Number
1326617|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 30 kg/m2, ITT Dataset|Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 30 kg/m2, ITT dataset. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|1 year|ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.|||Pearl Index||95% Confidence Interval|Number
1326618|NCT02158572|Primary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.|The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|1 year|ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.|||Pearl Index||95% Confidence Interval|Number
1326619|NCT02158442|Primary|Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.|Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the efficacy of Timentin delivered by PILP procedure (Treatment Group) versus intravenous delivery (Control Group) at reducing microbiological load in subjects with diabetes, and significant wound infection of the lower limb.|Day 3|"Treatment Group: 5 of the 5 analyzable microbiological loads resulted in a reduction. 1 was not analyzable.~Control Group: 3 of the 3 analyzable microbiological loads resulted in a reduction. 4 were not analyzable."|||participants|||Number
1326620|NCT02158364|Secondary|Number of Participants With Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to Day 28|"Vaccinated Safety Analysis Set included all participants who received measles/rubella combined vaccine Takeda as the second vaccination. Here number of participants analyzed are participants evaluable for this outcome measure."|||Participants|||Count of Participants
1326621|NCT02158364|Primary|Number of Participants With Serious Adverse Drug Reactions (ADRs)|Serious ADRs are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, ADRs were assessed as endpoint.|Up to Day 28|"Vaccinated Safety Analysis Set included all participants who received measles/rubella combined vaccine Takeda as the second vaccination. Here number of participants analyzed are participants evaluable for this outcome measure."|||Participants|||Count of Participants
1326622|NCT02158273|Secondary|Change From Baseline in Standard Drinks Per Week at 1 Week|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.|1 week||||drinks/week||Standard Deviation|Mean
1326623|NCT02158273|Primary|Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period|The four Visual Analog Scale (VAS) questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. Each VAS scale item score ranges from 1-20 where a one indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four VAS item scores (i.e. Intent, Impulse, Relief, Strength) and ranges in value from 4-80 with higher scores indicative of a worse outcome.|1 week following administration of fenofibrate||||units on a scale||Standard Deviation|Mean
1326624|NCT02158247|Primary|Airway Length vs Height in Female||Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
1326625|NCT02158247|Primary|Airway Length vs Height in Male||Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
1326626|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 23cm.~Conventional method : depth of intubation is 21cm at the medial incisor for female.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
1326628|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 25cm.~Conventional method : depth of intubation is 23cm at the medial incisor for male.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
1326629|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is below 25cm.~Conventional method : depth of intubation is 23cm at the medial incisor for male.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
1326630|NCT02158247|Primary|Comparison of Airway Length Between Male and Female|Airway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
1326631|NCT02158039|Primary|Number of Subjects With Complete or Partial Ablation of the Treated Cyst|Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)|1 year after final treatment||||participants|||Number
1326632|NCT02158039|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability|1 year after final treatment||||participants|||Number
1326633|NCT02157948|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)||Baseline, month 1, month 6 and month 12|"The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
1326634|NCT02157948|Secondary|Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)||Baseline, month 1, month 6 and month 12|"The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
1326635|NCT02157948|Primary|Percent Change From Baseline in Lumbar Spine BMD|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 12|The primary efficacy analysis subset included all randomized participants who had a baseline lumbar spine DXA BMD measurement and at least 1 postbaseline lumbar spine DXA BMD measurement. Postbaseline BMD values obtained at the early termination visit were carried forward as the month-12 value.|||percent change||Standard Deviation|Mean
1326636|NCT02157935|Secondary|Nights With Awakening Due to COPD|"Nighttime awakening due to COPD symptoms correspond to the severity of nocturnal symptoms from COPD.~The average number of awakening per night over the treatment period was analyzed. It was derived as the number of night with awakening divided by the total number of nights with data in the recording period. Change from baseline period on awakening was summarized and compared between two arms using a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline on awakening were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 603 patients in Symbicort group and 610 patients in Formoterol group had valid data and included in analysis.|||awakening/night||Standard Deviation|Mean
1326637|NCT02157935|Secondary|Total Rescue Medication Use (Average Puffs/Day)|"Use of rescue medication is a measure of symptoms that need to be treated with a short-acting bronchodilator.~The average daily use across the observation period was used for analysis. Change from baseline was summarized and compared between two arms using a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline on rescue medication use were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 602 patients in Symbicort group and 607 patients in Formoterol group had valid data and included in analysis.|||puffs/day||Standard Deviation|Mean
1326638|NCT02157935|Secondary|Pre-dose/Pre-bronchodilator FEV1 at the Study Site|FEV1 from pre-dose spirometry is a measurement of lung function. The change from baseline on pre-dose FEV1 was summarized and compared between Symbicort and Formoterol groups using a mixed model.|From Run-in W -4 to EoT W 26|The change from baseline in pre-dose FEV1 were analyzed on randomized patients with a baseline pre-dose FEV1 and at least one post-baseline value. Among 1219 patients who were randomized, only 588 patients in Symbicort group and 589 patients in Formoterol group had valid data and included in analysis.|||L||Standard Deviation|Mean
1326639|NCT02157935|Secondary|St. George’s Respiratory Questionnaire (SGRQ)|"SGRQ is a standardized, self-administered tool for measuring impaired health and perceived wellbeing in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study.~The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact).~Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100:~zero (0) score indicating no impairment of quality of life.~The total SGRQ score ranging from 0 to 100 is a summary score utilizing responses to all items calculated using weights attached to each item of the questionnaire.~Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status.~The change from baseline was statistically summarized and compared between two arms in a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline in SGRQ were analyzed on randomized patients with a baseline SGRQ and at least one post-baseline value. Among 1219 patients who were randomized, only 589 patients in Symbicort group and 593 patients in Formoterol group had valid data and included in analysis.|||scores on a scale||Standard Deviation|Mean
1326640|NCT02157935|Secondary|Number of Patients With Moderate or Severe COPD Exacerbation.|"The number of patients who developed moderate or severe COPD exacerbation during treatment period were reported. Cox proportional hazards regression model was fitted to data to compare the two treatment arms .~The hazard ratio and 95% CI were estimated."|From randomzation to EoT W 26||||Participants|||Number
1326641|NCT02157935|Primary|The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days|"The annual COPD exacerbation rate was analyzed and compared between two arms.~Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years.~The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model.~Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations.~Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics.~Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting)."|Randomization at Week 0 to End of Treatment (EoT) W 26|Full analysis set including all randomized subjects|||COPD exacerbations per year||95% Confidence Interval|Least Squares Mean
1326642|NCT02157909|Primary|Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes|With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of “no re-fit,” an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.|Dispense (Day 0), Week 1|This analysis population includes all randomized and treated subjects.|||percentage of subjects|||Number
1326643|NCT02157883|Secondary|AUC of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations, where AUC possible to calculate, and including Period 2 data (all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).|||nM*h||Full Range|Geometric Mean
1326644|NCT02157883|Secondary|Cmax of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of maximum plasma AZ7550 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and including Period 2 data (since all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).|||nM||Full Range|Geometric Mean
1326645|NCT02157883|Secondary|AUC of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).|||nM*h||Full Range|Geometric Mean
1326646|NCT02157883|Secondary|Cmax of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of maximum plasma AZ5104 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).|||nM||Full Range|Geometric Mean
1326647|NCT02157883|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||L||Full Range|Geometric Mean
1326648|NCT02157883|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||L/h||Full Range|Geometric Mean
1326649|NCT02157883|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||hours||Full Range|Geometric Mean
1326650|NCT02157883|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||hours||Full Range|Median
1326731|NCT02156271|Secondary|Change in Total Sleep Time|Change in sleep time will be determined by PSG.|Day -1-0, Day 89-90|Data was not collected, and therefore not analyzed.||||||
1326651|NCT02157883|Secondary|AUC(0-t) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration curve from time zero to last quantifiable dose|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM*h||Full Range|Geometric Mean
1326652|NCT02157883|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM*h||Full Range|Geometric Mean
1326653|NCT02157883|Primary|AUC of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM*h||Full Range|Geometric Mean
1326654|NCT02157883|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM||Full Range|Geometric Mean
1326655|NCT02157623|Secondary|Patient Satisfaction Survey|Overall patient satisfaction with the technique will be assessed using a simple survey.|6 months|||||||
1326656|NCT02157623|Secondary|Pain Score on a Visual-Analog Scale|Tolerability, defined as pain during treatment using Red light versus Blue light PDT, will be assessed.|6 months|||||||
1326657|NCT02157623|Primary|Tumor Clearance Rate|The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared.|6 months|study terminated, no outcomes||||||
1326658|NCT02157376|Secondary|Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase|"Criteria for a significant upper GI bleeding as described in primary outcome measure or,~Criteria for a non-significant upper GI bleeding as:~Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or,~Persistent gastroccult- positive coffee ground material~During IMP treatment Day 1-2:~Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline.~During IMP treatment Day 3-14:~Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or,~Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.|||proportion of participants|||Number
1326659|NCT02157376|Primary|The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase|"Criteria for a clinically significant upper GI bleeding as:~Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or,~Persistent gastroccult- positive coffee ground material~During IMP treatment Day 1-2:~Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline.~During IMP treatment Day 3-14:~Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.|||% of participants|||Number
1326660|NCT02157298|Secondary|Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%|Proportion of participants with mean daily insulin dose reduction greater than or equal 10% from baseline to week 16 (LOCF) between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) value|||percentage of participants||95% Confidence Interval|Least Squares Mean
1326661|NCT02157298|Secondary|Total Mean Daily Insulin Dose|Mean change in calculated mean daily insulin dose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||IU/Day||95% Confidence Interval|Least Squares Mean
1326662|NCT02157298|Secondary|Total Body Weight|Mean change in total body weight from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||kg||95% Confidence Interval|Least Squares Mean
1326663|NCT02157298|Secondary|Fasting Plasma Glucose|Mean change in fasting plasma glucose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||mg/dL||95% Confidence Interval|Least Squares Mean
1326664|NCT02157298|Primary|Adjusted Mean Change in HbA1c Levels|Mean change in HbA1c levels from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||percentage of hemoglobin glycosylated||95% Confidence Interval|Least Squares Mean
1326665|NCT02157168|Other Pre-specified|Informed Decision Making Regarding the Healthcare System and Their Health|The short form of the Patient Activation Measure (PAM), a measure of patient engagement in their healthcare. PAM levels of engagement with Level 4 being the highest level.|Baseline and 6 months|IG1 group members that completed the baseline and 6-month survey and CG and IG2 group members that complete the 6-month survey.|||Participants|||Count of Participants
1326666|NCT02157168|Secondary|The Impact of the Intervention on Preventable Hospital Stays|The number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment.|6 months|Members who had a hospital visit during the first 6 months of enrollment.|||Participants|||Count of Participants
1326667|NCT02157168|Secondary|The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits|The number and percentage of new members who had avoidable emergency department (ED) visits during their first 6 months of enrollment.|6 months|Members who had an ED visit during the first 6 months of their enrollment.|||Participants|||Count of Participants
1326668|NCT02157168|Secondary|The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services|The number and percentage of new members who had at least one preventive visit (i.e., well woman visit, cervical cancer screening, sexually transmitted infection (STI) screening, STI counseling, contraception counseling or immunizations) during their first 6 months of enrollment.|6 months||||Participants|||Count of Participants
1326669|NCT02157168|Primary|Identify and Utilization of Primary Care Provider (PCP)|The number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.|6 months||||Participants|||Count of Participants
1326670|NCT02157116|Secondary|Overall Survival||Approximately 10 years|Due to insufficient accrual, the study was stopped prior to completing the 10 year followup for survival.||||||
1326671|NCT02157116|Secondary|Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction||During induction, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.||||||
1326672|NCT02157116|Secondary|Number of Grade III/IV Non-hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.||||||
1326673|NCT02157116|Secondary|Number of Grade III/IV Hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.||||||
1326674|NCT02157116|Primary|Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy||at the end of the study, estimated 2.5 years|Due to insufficient accrual, gene analysis was not performed.||||||
1326675|NCT02157116|Primary|Induction Response|Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.|Between 2 and 3 weeks after induction|Due to insufficient accrual, data analysis was not performed.||||||
1326676|NCT02157103|Secondary|Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab|Participants may switch from subcutaneous bevacizumab on study to standard of care intravenous bevacizumab. In these participants, we will measure decrease of edema after this switch. A further decrease in edema after making this switch would suggest intravenous to be superior to subcutaneous as regards decreasing edema. The therapeutic benefit of bevacizumab as regards GBM is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in edema. For purposes of this study, any reduction in edema by 25% or more will be considered a response.|Within 2 months of starting intravenous bevacizumab|One patient did not switch to standard of care intravenous bevacizumab.|||Participants|||Count of Participants
1326677|NCT02157103|Secondary|Number of Toxicities Reported in Study Participants|Subcutaneous bevacizumab may have toxicities unique to the subcutaneous administration and not seen with intravenous bevacizumab. During the first 3 weeks we will watch for such toxicities. Toxicities will be described and graded using the Common Toxicity Criteria for Adverse Effects (CTCAE) v3.|During first 3 weeks of study||||Toxicities|||Number
1326678|NCT02157103|Primary|Number of Participants With Change in Peritumoral Enhancement/Edema|To describe MRI response regarding edema and enhancement of glioblastoma and radiation-related brain enhancement when treated with subcutaneous bevacizumab daily. The therapeutic benefit of bevacizumab as regards glioblastoma multiforme (GBM) is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in enhancement and reduction in edema. For purposes of this study, any reduction in enhancement/edema by 25% or more will be considered a response.|1 cycle (3 weeks)||||Participants|||Count of Participants
1326679|NCT02156466|Secondary|Percentage of Subjects With Exacerbation of Psoriasis|Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit >=125% of baseline PASI).|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
1326680|NCT02156466|Secondary|Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85|The BSA is the physician’s evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district.|Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85|"Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). Here n signifies those subjects who were evaluable for this outcome measure at the specified time points."|||percent change||Standard Deviation|Mean
1326700|NCT02156466|Primary|Average Concentration (Cav) Post Third Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326681|NCT02156466|Secondary|Percentage of Subjects With Static Physician’s Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline|The static Physician’s Global Assessment (sPGA) scale rated the investigator’s overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported.|Day 8, 15, 22, 29, 36, 43, 50, 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
1326682|NCT02156466|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline, Day 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).|||units on a scale||Standard Deviation|Mean
1326683|NCT02156466|Secondary|Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
1326684|NCT02156466|Primary|Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841|The observed serum concentration immediately before second dose.|Pre-dose (0 hours) on Day 15|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326685|NCT02156466|Primary|Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326686|NCT02156466|Primary|Accumulation Ratio of AUC (Racc(AUC))|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1326687|NCT02156466|Primary|Accumulation Ratio of Cmax (Racc (Cmax))|Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1326688|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
1326689|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
1326690|NCT02156466|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||Liters||Geometric Coefficient of Variation|Geometric Mean
1326691|NCT02156466|Primary|Apparent Clearance (CL/f) Post Third Dose of MSB0010841|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||L/day||Geometric Coefficient of Variation|Geometric Mean
1326692|NCT02156466|Primary|Terminal Rate Constant (λz) Post Third Dose of MSB0010841|Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
1326693|NCT02156466|Primary|Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where ‘λz’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
1326694|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour||Full Range|Median
1326695|NCT02156466|Primary|Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour||Full Range|Median
1326696|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour||Full Range|Median
1326697|NCT02156466|Primary|Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841|Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
1326698|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
1326699|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post First Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
1326701|NCT02156466|Primary|Average Concentration (Cav) Post First Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326702|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326703|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326704|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1326705|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1326706|NCT02156466|Primary|Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the third dose.|Pre-dose (0 hours) on Day 29|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1326707|NCT02156466|Primary|Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the first dose.|Pre-dose (0 hours) on Day 1|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1326708|NCT02156466|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841|Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*ug/mL||Geometric Coefficient of Variation|Geometric Mean
1326709|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326710|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326711|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326712|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*microgram per milliliter (day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1326732|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|baseline||||units on a scale||Standard Deviation|Mean
1326713|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Third Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||ng/mL||Standard Deviation|Mean
1326714|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Second Dose||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||ng/mL||Standard Deviation|Mean
1326715|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After First Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received first dose of MSB0010841 without protocol deviations affecting PK, and who provide evaluable PK data. Here “n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1326716|NCT02156466|Primary|Levels of Pre-existing Anti-MSB0010841 Antibody Titers||Pre-dose on Day 1|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.|||log10titer|||Number
1326717|NCT02156466|Primary|Levels of Anti-MSB0010841 Antibody Titers||Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.|||log10titer|||Number
1326718|NCT02156466|Primary|Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])|Data were presented for MSB0010841 combined group and placebo.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
1326719|NCT02156466|Primary|Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)|Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value > 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.|Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “Number of subjects analyzed” signifies those subjects who were evaluable for this endpoint and “n” signifies those subjects who were evaluable at the specified time point.|||mm|||Number
1326720|NCT02156466|Primary|Number of Subjects With Local Injection Site Reactions (ISRs)|The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising area); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising area); Severe (>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable ‘firmness’ only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.|Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “n” signifies those subjects who were evaluable for the specified injection site reaction. Subjects may be represented in more than 1 category.|||subjects|||Number
1326721|NCT02156466|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).|||subjects|||Number
1326722|NCT02156271|Secondary|Interleukin 6 (IL-6)||Baseline||||pg/mL||Standard Deviation|Mean
1326723|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Baseline||||HOMA-IR value||Standard Deviation|Mean
1326724|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Baseline||||mg/L||Standard Deviation|Mean
1326725|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.|Baseline||||minutes||Standard Deviation|Mean
1326726|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Baseline||||minutes||Standard Deviation|Mean
1326727|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|day 89 - 90||||units on a scale||Standard Deviation|Least Squares Mean
1326733|NCT02156271|Primary|Change in Metabolic Syndrome (MetSyn)||Baseline, Day 30, Day 60, Day 89-90|Data was not collected, and therefore not analyzed.||||||
1327933|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||g/dL||Standard Deviation|Mean
1326735|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset.|Day 89-90||||minutes||Standard Deviation|Least Squares Mean
1326736|NCT02156167|Primary|Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test|"The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions.~Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810)."|3 months after initial upgraded fitting|One subject did not visit the clinic for the 3 months follow-up, a second subject did not perform the speech in noise test at the 3 months follow-up due to tiredness|||dB SNR||Standard Deviation|Mean
1326737|NCT02155985|Secondary|Change in Brachial Artery Flow-mediated Dilation (FMD) From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of brachial artery diameter||95% Confidence Interval|Mean
1326738|NCT02155985|Secondary|Change in Urine Thromboxane Per Creatinine From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
1326739|NCT02155985|Secondary|Change in Serum Thromboxane B2 From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
1326740|NCT02155985|Secondary|Change in Kynurenine to Tryptophan Ratio From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||1000 ng/ml kynurenine : ng/ml tryptophan||95% Confidence Interval|Mean
1326741|NCT02155985|Secondary|Change in D-dimer From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
1326742|NCT02155985|Secondary|Change in IL-6 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
1326743|NCT02155985|Secondary|Change in Expression of PD-1+ on CD8+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD8+ expressing PD-1+||95% Confidence Interval|Mean
1326744|NCT02155985|Secondary|Change in Expression of PD-1+ on CD4+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD4+ expressing PD-1+||95% Confidence Interval|Mean
1326745|NCT02155985|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD8+ expressing CD38+HLA-DR+||95% Confidence Interval|Mean
1326746|NCT02155985|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD4+ expressing CD38+HLA-DR+||95% Confidence Interval|Mean
1326747|NCT02155985|Secondary|Change in Expression of CD69+ on CD14+CD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD14+CD16+ expressing CD69+||95% Confidence Interval|Mean
1326748|NCT02155985|Secondary|Change in Expression of CD14+CD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD14+CD16+||95% Confidence Interval|Mean
1326749|NCT02155985|Secondary|Change in Expression of CD69+ on CD14+CD16- From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD14+CD16- expressing CD69+||95% Confidence Interval|Mean
1326750|NCT02155985|Secondary|Change in Expression of CD14+CD16- From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD14+CD16-||95% Confidence Interval|Mean
1326751|NCT02155985|Secondary|Change in Expression of CD69+ on CD14dimCD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD14dimCD16+ expressing CD69+||95% Confidence Interval|Mean
1326753|NCT02155985|Secondary|Change in sCD163 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
1326754|NCT02155985|Secondary|Tolerability|Tolerability was summarized as the number of participants successfully completing the protocol-defined treatment period.|Treatment dispensation to Week 12|All randomized participants.|||Participants|||Count of Participants
1326755|NCT02155985|Secondary|Safety|"Safety was summarized as the highest grade sign/symptom, laboratory event, or diagnosis per participant.~Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table."|After study entry to Week 16|All randomized participants.|||Participants|||Count of Participants
1326756|NCT02155985|Primary|Change in sCD14 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. Differences between arms are expressed as the percent difference between mean fold changes."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population. Participants 1) without baseline AND week 11/12 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) with a serious bacterial infection while on treatment, or 4) with <70% self-reported adherence (based on all available days of recall) to study treatment were excluded.|||fold change||95% Confidence Interval|Mean
1326757|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
1326758|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
1326759|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
1326760|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
1326761|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores|The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
1326762|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
1326763|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores|The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
1326764|NCT02155881|Primary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
1326765|NCT02155543|Primary|Maximal Plasma Concentration (Cmax) of AGN-223575|Concentrations of AGN-223575 were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 24 hours post-dose. The Cmax is reported.|Day 15|Pharmacokinetic Population: AGN-223575-treated subjects in cohorts with pharmacokinetic samples (i.e., Cohorts 2 to 5)|||Nanograms/Milliliters (ng/mL)||Standard Deviation|Mean
1326766|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 14 (2 weeks post injections)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire|||Percentage of Participants|||Number
1326767|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 0 (post last injection)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire|||Percentage of Participants|||Number
1326768|NCT02155322|Primary|Percentage of Participants Discontinuing Study Drug Because of AEs|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose to last dose of treatment; up to 12 months|All participants who received at least one dose of study drug.|||Percentage of participants|||Number
1326769|NCT02155322|Primary|Percentage of Participants Experiencing Adverse Events (AEs)|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose through follow-up; up to 13 months|All participants who received at least one dose of study drug.|||Percentage of participants|||Number
1326770|NCT02155309|Primary|Efficacy: Number of Head Movements During Rotation|During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).|40 min||||Number of head tilts||Standard Deviation|Mean
1326771|NCT02155283|Other Pre-specified|Change in Amount of Pain Determined by the NRS at the 1-week Follow-up After the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|4 weeks||||units on a scale||Standard Deviation|Mean
1326772|NCT02155283|Secondary|Change in Heart Rate Variability (and the Autonomic System)|"Gather information regarding:~Autonomic nervous system activity by measuring heart rate variability (HRV)."|3 weeks, 4 weeks|||||||
1326773|NCT02155283|Secondary|Change in Symmetry of Muscle Function on Either Side of the Spine|"Gather information regarding:~Symmetry of muscle function about the spine using static surface electromyography (SEMG)"|3 weeks, 4 weeks|||||||
1326774|NCT02155283|Secondary|Change in Functional Health Status by ODI|Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)|3 weeks, 4 weeks|||||||
1326775|NCT02155283|Secondary|Change in Proprioception and Vestibular Function.|"Gather information regarding:~Balance and Fall Prevention using digital posturography"|3 weeks, 4 weeks|||||||
1326776|NCT02155283|Primary|Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|3 weeks|Completers per protocol|||units on a scale||Standard Deviation|Mean
1326777|NCT02155010|Secondary|Patient's Anxiety|We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.|up to 3 days||||points||Standard Deviation|Mean
1326778|NCT02155010|Primary|Incidence of Hypotension|We compare incidence rate of hypotension during infusion of dexmedetomidine|up to 3 hours||||participants|||Number
1326779|NCT02154906|Secondary|Change in Radiographic Bone Level|measurement of radiographic bone level at the time of surgical intervention will be compared with measurement of bone level 6 months after surgery|baseline and 6 months after surgery||||mm||Standard Deviation|Mean
1326780|NCT02154906|Primary|Change in Clinical Attachment Level (CAL)|measurement of CAL at the time of surgical intervention will be compared with measurement of CAL and bone level 6 months after surgery|baseline and 6 months after surgery||||mm||Standard Deviation|Mean
1326781|NCT02154425|Primary|The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)|Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.|From Day 0 to Day 14 or 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326782|NCT02154425|Primary|The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable. Measurement on day 28 applies to subjects on a CZP 400mg Q4W dosing regimen only.|||mg/kg/day||Full Range|Median
1326783|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14|Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326784|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326785|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326786|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326787|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326788|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326789|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
1326790|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326791|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14|Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Mean
1326792|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326793|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326794|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326795|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326796|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326797|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326798|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0|Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.|Day 0|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
1326799|NCT02154386|Secondary|Change in Buccal Ridge Height|Ridge height measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge height are determined (negative number signifies loss of ridge height)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting||||change in bone height (mm)||Standard Deviation|Mean
1326800|NCT02154386|Secondary|Change in Ridge Width|Ridge width measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge width are determined (negative number signifies loss of ridge width)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting||||ridge width change (mm)||Standard Deviation|Mean
1326801|NCT02154386|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|after removal of bone core from site of dental implant placement at 18-20 weeks following tooth extraction and grafting||||percentage of vital bone||Standard Deviation|Mean
1326802|NCT02154243|Secondary|Length of Stay||Length of the hospital stay (average of 4 days)|DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.||||||
1326803|NCT02154243|Primary|Change in Orthostatic Hypotension Questionnaire Score||From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)|DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.||||||
1326804|NCT02154139|Secondary|Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy|Recurrence-free survival was determined in participants who were treated with the drug as adjuvant therapy, and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
1326805|NCT02154139|Secondary|Percentage of Participants With Progression Free Survival|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
1326806|NCT02154139|Secondary|Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions greater than or equal to (>=) 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of >= 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Week 24, 48,96|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
1326807|NCT02154139|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.|||participants|||Number
1326808|NCT02154139|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.|||participants|||Number
1326809|NCT02154087|Primary|Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247|The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects’ quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).|Wound fluid samples were to be collected one week after the initial dose of HP802-247.|Due to the failure of HP802-247-09-029 to show superiority over its vehicle in study 802-247-09-029, this study was terminated after enrollment of one of the proposed 25 subjects. No data was collected.||||||
1326810|NCT02154061|Primary|Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30|Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples|At day 30|"The Overall Number of Participants analyzed for IIV Flu Vaccine with Antibiotics is 15, as one participant received antibiotics and did not receive vaccine. The study personnel were unable to draw blood on her at the vaccination day- therefore she was part of the safety population and not the immunogenicity population."|||Participants|||Count of Participants
1326811|NCT02154048|Primary|Time to First Analgesic Dose||48 hours|one subject in the Local Anesthetic (LA) Control Group was not analyzed because subject did not return the data sheet|||hours||Standard Deviation|Mean
1326812|NCT02153827|Secondary|Upper Quarter Y Balance Test|Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.|6 months||||cm of reach divided by limb length||Standard Deviation|Mean
1326813|NCT02153827|Secondary|Shoulder Active Range of Motion|Degrees of shoulder elevation with 0 being the least and 180 being the greatest.|6 months||||Degrees||Standard Deviation|Mean
1326814|NCT02153827|Secondary|Numeric Pain Rating Scale|0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.|6 months||||units on a scale 0-10||Standard Deviation|Mean
1326815|NCT02153827|Secondary|Global Rating of Change|Global rating of change is a single item questionnaire asking about total change since beginning treatment. The scale ranges from -7 (a great deal worse) to +7 (a great deal better). The unit of measure is scores on a scale.|6 months||||units on a scale||Standard Deviation|Mean
1326816|NCT02153827|Primary|Change in Western Ontario Rotator Cuff Index|shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.|6 months||||units on a scale derived from 100cm vas||Standard Deviation|Mean
1326881|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1326817|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
1326818|NCT02153788|Secondary|Mean Change in the Distress Thermometer|A clinical tool that has been validated widely especially in cancer patients, to detect clinically significant emotional distress. This is a one-item scale that asks participants to rate their distress on scale from 0-100. Lower scores represent less distress and higher scores indicate greater distress.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
1326819|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
1326820|NCT02153788|Secondary|Mean Change in Piper Fatigue Score|A multidimensional scale for measuring fatigue, whose validity and reliability have been established across many patient populations including cancer patients, HIV, pregnancy, and myocardial infarction. There are 22 questions, in 3 subscales that measure behavioral, affective meaning, sensory and cognitive/mood aspects of fatigue, each scored on an 11-point likhert scale with a score of 0-10, 0 indicating no fatigue and 10 indicating the most severe fatigue. The Piper Fatigue Scale can range from 0 to 220 with higher scores indicating greater fatigue.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
1326821|NCT02153788|Secondary|Mean Change in Self-reported Total Sleep Time|Mean change in self-reported total sleep time from randomization to the end of the open label phase|Randomization to the end of the open label phase, approximately 1 week|Data not collected, and therefore not analyzed.||||||
1326822|NCT02153788|Secondary|Mean Change in Self Reported Total Sleep Time|Mean change in self reported Total Sleep Time from Randomization to Final Study Visit in the placebo-controlled phase.|Randomization to final study visit, approximately 12 weeks|Data not collected, and therefore not analyzed.||||||
1326823|NCT02153788|Primary|Mean Change in the Insomnia Severity Index|Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.|Randomization to final study visit, approximately 12 weeks||||units on a scale||Standard Deviation|Mean
1326824|NCT02153736|Secondary|Test of Infant Motor Performance (TIMP)|The TIMP is a standardized and norm references test of motor control and posture in infants 4 months of age and younger which is commonly used with infants starting at 34 weeks of post-menstrual age. Change in raw score from baseline to end of the intervention is reported. The TIMP raw score ranges from 0 to 142. A higher score represented greater performance in motor control and posture.|Baseline to End of intervention|Full Sample after infants lost to follow up who are not included in this analysis.|||Raw Score on the TIMP||Inter-Quartile Range|Median
1326825|NCT02153736|Secondary|Bayley Scales of Infant and Toddler Development (Bayley).|The Bayley-III is a norm references standardized developmental assessment of Motor, Cognitive, and Language skills. Composite scores for each domain have a mean of 100 and a standard deviation of 15. A score of 85-115 is considered average. Higher composite scores represent higher or better performance on that subtest. The Bayley was administered at the final follow-up visit and 3 months after the intervention ended.|3 month post intervention|At 3 months post intervention the sample was consistent with that described in the study sample post lose to followup.|||Mean Composite Score on Bayley||Standard Deviation|Mean
1326826|NCT02153736|Secondary|Parent Child Early Relational Assessment (PCERA)|The Parent-Child Early Relational Assessment (PCERA; Clark, 2010; Clark, 1999) was designed to assess mother-infant interaction. In this study PCERA was scored from a video of the feeding interaction. The PCERA is a 65-item observational rating scale (29 parental, 27 infant, and 8 dyadic), designed to assess the amount, duration, and intensity of interaction. Each item was rated on a 3-point ordinal scale with 1-2 indicating an area of concern, 3 indicating an area for some concern and 4- 5 indicating an area of strength. Eight subscales constructed from items of the PCERA have been theoretically derived and confirmed by factor analysis (Clark, 1999; Clark et al., 1997). For ease of analysis this scale was transformed to a -1 to +1 range. Scores were recorded as 1 or 2 = -1, 3= 0, 4 or 5 = 1. The total PCERA score is the mean of all the subscale mean scores and ranged -1 (highest risk of atypical interactions) to +1 (most positive interactions).|Baseline, End phase 1, End of intervention, 1 month post intervention|The sample varied some between visits do to a lack of video taping the parent child interaction on a few occasions because the parent who consented to the study was not present at the time of the visit and the visit could not be rescheduled. The 3 month post intervention visit was dropped.|||Mean Score on PCERA||Standard Deviation|Mean
1326840|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Evening COPD Symptom Severity|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
1326956|NCT02151253|Secondary|Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)|Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week|week 4 of each phase.||||Nocturic Events||Standard Deviation|Mean
1326827|NCT02153736|Secondary|Early Feeding Skill Assessment (FES)|The Early Feeding Skills (EFS) was used to assess the infant’s oral feeding skills during the video recorded feeding described above. The EFS is a 26-item observational tool that can be used from the start of oral feeding through the maturation of feeding skills. Each item can score 1-3 with one representing the least skill or high frequency of problem (an area of clinical concern), and three representing mature skill or absence of problem (area of strength). Subscales included were ability to maintain engagement in feeding, ability to organize oral-motor functioning, ability to coordinate swallowing, and ability to maintain physiological stability. The sum of all the items in a subscale divided by the number of items in the subscale gives the subscale score of 1-3. The sum of all subscales was used to create an EFS total score which could range from 2 to 12 with a higher score reflecting a better feeding performance.|Baseline, End phase 1, End of intervention, 1 and 3 months post intervention|Some infants were not able to orally feed in which case this measure was not included. In addition, some visits were missing feeding assessments for missing data. Thus the sample included varied some between visits.|||EFS Total score||Standard Deviation|Mean
1326828|NCT02153736|Primary|Early Problem Solving Indicator (EPSI)|Problem-solving behaviors were assessed using the Early Problem Solving Indicator (EPSI). The EPSI is the cognitive subtest of the Individual Growth and Development Indicators designed to measure infant and toddler play-based problem-solving through 36 months of age. It defines problem-solving as consisting of visual exploration, object manipulation and memory. The infant was video-recorded interacting with 3 standard toys: pop-up animals toy, 6 seriated, plastic cups, and a gum ball machine with 5 balls. Infants were given each toy for 2 minutes. The frequency of 4 mutually exclusive behaviors (look, explore, function, solution) were coded using definitions from the EPSI protocol. time. The total number of problem solving behaviors was calculated as a sum of look, explore, function, and solution for each infant at each visit and reported as the total EPSI frequency with a higher frequency reflecting more problem solving behaviors.|End of intervention, 1 and 3 months post intervention|Same as primary population with the 2 infants lost to follow up not included.|||# of Problem Solving Behaviors in 6 min||Standard Deviation|Mean
1326829|NCT02153736|Primary|Reaching (Toy Contact Duration)|Duration the infant is in contact with the target is used to quantify changes in reaching.|1 month post intervention||||Seconds||Standard Deviation|Mean
1326830|NCT02153489|Other Pre-specified|Change From Baseline in Number of Steps Per Day||Week 3 of treatment||||Number of steps per day||Standard Error|Least Squares Mean
1326831|NCT02153489|Other Pre-specified|Change From Baseline in Duration of at Least Moderate Activity|Moderate activity was defined as any physical activity >3 metabolic equivalents|Week 3 of treatment||||Minutes||Standard Error|Least Squares Mean
1326832|NCT02153489|Other Pre-specified|Change From Baseline in Total Sleep Time||Week 3 of treatment||||Minutes||Standard Error|Least Squares Mean
1326833|NCT02153489|Other Pre-specified|Change From Baseline in Sleep Efficiency|Sleep efficiency is calculated as the total sleep time as a proportion of total time in bed|Week 3 of treatment||||Percentage of total time in bed||Standard Error|Least Squares Mean
1326834|NCT02153489|Other Pre-specified|Change From Baseline in Proportion of Sleep Stage REM as a Percentage of Total Sleep Time||Week 3 of treatment||||Percentage of total sleep time||Standard Error|Least Squares Mean
1326835|NCT02153489|Other Pre-specified|Change From Baseline in Oxygen Desaturation Index (ODI) Per Hour of Total Sleep Time|The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. In this study, any event with a 4% decrease in blood oxygen levels counted towards the total|Week 3 of treatment||||Events/hr||Standard Error|Least Squares Mean
1326836|NCT02153489|Other Pre-specified|Change From Baseline in Apnea-hypopnea Index (AHI) Per Hour of Total Sleep Time|The Apnea Hypopnea Index (AHI) is used to indicate the severity of obstructive sleep apnea. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep|Week 3 of treatment||||Events/hr||Standard Error|Least Squares Mean
1326837|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Evening Activities|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
1326838|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Early Morning Activities|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
1326839|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Night-time COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
1326954|NCT02151461|Secondary|Change From Baseline to Day 28 in Incremental Plasma Glucose Area Under the Curve (AUC)|The baseline incremental (baseline-subtracted) glucose AUC0-3h was evaluated for treatment differences at baseline.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of Incremental Plasma Glucose AUC change from day 1-day 28 Evaluable Population (n=73)|||mg*hrs/dL||Standard Deviation|Mean
1326841|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Early Morning COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
1326842|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC12-24hr||12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment||||L/sec*hr||Standard Error|Least Squares Mean
1326843|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC0-12hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment||||L/sec*hr||Standard Error|Least Squares Mean
1326844|NCT02153489|Other Pre-specified|Change From Baseline in Peak FEV1||Week 3 of treatment||||Liters/sec||Standard Error|Least Squares Mean
1326845|NCT02153489|Other Pre-specified|Change From Baseline in Morning Trough FEV1||Week 3 of treatment||||Liters/sec||Standard Error|Least Squares Mean
1326846|NCT02153489|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment||||L/sec*hr||Standard Error|Least Squares Mean
1326847|NCT02153476|Secondary|1) Non-surgical Closure of Full Thickness Macular Holes 2) Best Corrected Visual Acuity (BCVA) 3) Need for Pars Plana Vitrectomy (PPV)|The secondary endpoints of this study are the observations of: (a) non-surgical closure of full thickness macular holes; (b) BCVA; and (c) need for pars plana vitrectomy.|90 days|||||||
1326848|NCT02153476|Primary|Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)|The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT.|90 Days||||Participants|||Count of Participants
1326849|NCT02153398|Secondary|Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||L||Standard Deviation|Mean
1326850|NCT02153398|Secondary|Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||L/h||Standard Deviation|Mean
1326851|NCT02153398|Secondary|Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||hour||Standard Deviation|Mean
1326852|NCT02153398|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||hour||Full Range|Median
1326853|NCT02153398|Secondary|Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||μmol/L||Standard Deviation|Mean
1326854|NCT02153398|Secondary|AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||μmol*h/L||Standard Deviation|Mean
1326855|NCT02153398|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the pharmacokinetics (PK).|||μmol*h/L||Standard Deviation|Mean
1326856|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326857|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326870|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Patient Diaries|"The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
1326858|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326859|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326860|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326861|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326862|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326863|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
1326864|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Patient Diaries|"The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
1326865|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
1326866|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Patient Diaries|"The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
1326867|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Patient Diaries|"The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no heartburn at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
1326868|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Patient Diaries|"The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
1326869|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
1326880|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse [beats per minute (bpm)], and resting blood pressure and after standing.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1326871|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Patient Diaries|"The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
1326872|NCT02153346|Secondary|Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points|WPAI is a self-administered instrument to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days and yields 4 types of scores: Absenteeism (work time missed/missed due to other reasons); Presenteeism (actual time worked); Work Productivity Loss (affected productivity while working); and Activity Impairment (affected regular activities). The following parameters were presented: Hours (Hrs) missed due to asthma (HMA), Hrs missed due to other reasons (HMO), and Hrs actually worked (HAW); all in the last 7 days.|At BL, 4-Month, 8-Month and 12-Month FUP|Source Population. Only par. with available data in each category (represented by n=X in the category title) were analyzed. Among the 101 par., 35 (35%) were retired and 59 (58%) were working. Only par. working were who completed the WPAI questionnaire were included in the analysis (56 at BL; 49 at 4 months; 37 at 8 months; 44 at FUP).|||Hours||Standard Deviation|Mean
1326873|NCT02153346|Primary|Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP|Costs of asthma may vary depending on the participant’s asthma severity. Asthma severity was based on the standard definitions for severity and ACQ scores: Mild (<0.75), Moderate (>0.75) and Severe (any ACQ score). The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).|BL and 12-month FUP|Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).|||Canadian Dollars||Standard Deviation|Mean
1326874|NCT02153346|Primary|Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP|Costs of asthma are greater when the asthma is sub-optimally managed and controlled and varies depending on the par. asthma control. Asthma control was assessed using the Asthma Control Questionnaire (ACQ) and par. were asked to recall their experiences during the previous week and respond to the 6 specified questions on a 7-point Likert scale (0=well-controlled; 6=maximum impairment [poorly controlled]; a score of ≤0.75 indicates well controlled symptoms. The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA). Only 59 par. were active workers. When stratified by asthma control and severity each stratum had a sample less than 59. Although results are presented. data may not be reliable due to the low number of par. in each stratum.|BL and 12-month FUP|Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).|||Canadian Dollars||Standard Deviation|Mean
1326875|NCT02153346|Primary|Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)|Participants completed questionnaires within 2 weeks post-recruitment, 4, 8 and 12 months to measure indirect cost of disease, specifically related to productivity. The following questionnaires were used: WPAI helps to determine presenteeism, absenteeism, and total cost calculation (TCC) possible (number of days during the year of study), while VOLP is used to assess the impact of health conditions on lost productivity in monetary units (United states dollars). The following parameters were calculated: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).|BL and at 12-month FUP|Source Population: all par. with asthma diagnosed by respirologist and followed at outpatient asthma clinic of the HSCM and registered in BD-Asthma/RESP. Only par. with available data in each category (represented by n=X in the category title) were analyzed. One third of par. selected were retired. Only 59 were active workers (52 at BL; 40 at FUP).|||US Dollars||Standard Deviation|Mean
1326876|NCT02153099|Secondary|Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for ENV8058 (TAK-058)|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK population included all enrolled participants.|||hours||Standard Deviation|Mean
1326877|NCT02153099|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for ENV8058 (TAK-058)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.|||ng*hr/mL||Standard Deviation|Mean
1326878|NCT02153099|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ENV8058 (TAK-058)|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.|||ng*hr/mL||Standard Deviation|Mean
1326879|NCT02153099|Secondary|Cmax: Maximum Observed Plasma Concentration for ENV8058 (TAK-058)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|Pharmacokinetic (PK) Population included all enrolled participants.|||ng/mL||Standard Deviation|Mean
1326957|NCT02151253|Secondary|Mean Number of Minutes Napped Per Day Based on Sleep Diary|measurements are for the preceding week|week 4 of each phase.||||minutes napped per day||Standard Deviation|Mean
1326882|NCT02153099|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|Baseline up to Day 30|Safety population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1326883|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function|"Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1326884|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence|"Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1326885|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning|"Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1326886|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening|"Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1326887|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality|"Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1326888|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration|"Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1326889|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset|"Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1326890|NCT02153086|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||number of awakenings||Standard Deviation|Mean
1326891|NCT02153086|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||hours||Standard Deviation|Mean
1326892|NCT02153086|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||minutes||Standard Deviation|Mean
1326893|NCT02153086|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1326894|NCT02152605|Secondary|Change From Baseline (BL) in Mean Number of Puffs of Rescue Medication Per Day Used Over Weeks 1-12|Albuterol/salbutamol(A/S) was used as rescue medication and was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout treatment periods. The number of puffs of rescue medication (A/S) per day over the entire 12 week treatment period was recorded and analyzed. For rescue use, ‘day’ is referred as the period between one record of rescue use and the next. Total puffs of rescue for each day = number of salbutamol puffs + (2 x number of salbutamol nebules). Analysis performed using mixed model repeated measures with covariates of BL(mean number of total puffs over the duration from First Day; defined as Latest of [7 days before Visit 2 and day after Visit 1] to Last Day(defined as Day before Visit 2)), smoking status, centre group, four-week period, treatment and period by BL interaction. Change from BL used weeks 1-4, 5-8, and 9-12 as covariates in the model and the overall least squares mean change for weeks 1-12 is estimated.|Week 1 amd Week 12|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents all par. in the ITT population without missing covariate information and with at least one post BL measurement.|||puffs per day||Standard Error|Least Squares Mean
1326895|NCT02152605|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 28, 56 and 84. Baseline is defined as the assessment taken pre-dose on Treatment Day 1. Trough FEV1 is defined as the FEV1 value obtained 24 hours after the previous morning's dosing. Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liter||Standard Error|Least Squares Mean
1326896|NCT02152605|Primary|Change From Baseline in Mean St.George’s Respiratory Questionnaire (SGRQ) Total Score at Day 84|The SGRQ is a disease-specific questionnaire, self-completed by participants(par), used to evaluate the effect of UMEC/VI on health-related quality of life as compared to placebo in par with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Analysis was performed using mixed model repeated measures with covariates of Baseline (scores recorded prior to dosing on Day 1) SGRQ total score, centre group, smoking status, Day, treatment(trt), Day by Baseline interaction and Day by trt interaction, where Day is nominal. Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Score on scale||Standard Error|Least Squares Mean
1326897|NCT02152566|Primary|Treatment Efficacy|The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.|During 1 night of Sleep on PSG|Out of 6 patient enrolled, 2 withdrew before participating in the study, 1 did not turn up to his appointment. From 3 participants who took part in the study,1 had a positive diagnosis of Cheyne-Stokes Respiration (CSR). The 1 patient who underwent treatment found the device too uncomfortable therefore no outcome measure data were available.||||||
1326898|NCT02152371|Secondary|Rate of Hypoglycemic Events up to 28 Weeks|The rate of total hypoglycemic events any type per 30 days is presented. The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||rate of hypoglycemic events per 30 days||Standard Deviation|Mean
1326899|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)||28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
1326955|NCT02151461|Primary|Change From Baseline to Day 28 in Absolute Plasma Glucose Area Under the Curve (AUC) 0-3hr|The primary endpoint for NS 0100 01 was the absolute plasma glucose AUC (0-3 hr) change from Day 1 to Day 28.|0, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs and 3 hrs|Mixed Model Inferential Statistical Analysis of Plasma Glucose AUC change from day 1-day 28 Evaluable Population (n=73)|||mg*hrs/dL||Standard Deviation|Mean
1326900|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants achieving target HbA1c of <7.0% at 28 weeks without documented symptomatic hypoglycemia are presented. Documented symptomatic hypoglycemia is defined as any time a participant experienced symptoms and or signs associated with hypoglycemia and had a plasma glucose of <=70 mg/dL.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values|||percentage of participants|||Number
1326901|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants who achieved a target HbA1c target of <7%, without weight gain and without documented symptomatic hypoglycemia at 28 weeks were analyzed using regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data.Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
1326902|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%|Percentage of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had a baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
1326903|NCT02152371|Secondary|Number of Participants With Dulaglutide Anti-Drug Antibodies|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 12 and 28. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline, Week 12 and Week 28|All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.|||participants|||Number
1326904|NCT02152371|Secondary|Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1326905|NCT02152371|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of cases of acute pancreatitis confirmed by adjudication. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1326906|NCT02152371|Secondary|Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1326907|NCT02152371|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The percentage of participants with self-reported hypoglycemic events is presented.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1326908|NCT02152371|Secondary|Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events|Cardiovascular (CV) adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the sponsor. Deaths occurring during the study treatment period and nonfatal CV AEs were to be adjudicated. Nonfatal CV events that were to be adjudicated were myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (CVA/stroke), and transient ischemic attack (TIA).|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study.|||participants|||Number
1326909|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose|Least Square (LS) Means of the insulin dose change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline insulin dose as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who one dose of study drug and had evaluable baseline and post-baseline insulin glargine data.|||units (u)||Standard Error|Least Squares Mean
1326910|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Body Weight|LS means of the body weight change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline body weight as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data.|||kilogram(kg)||Standard Error|Least Squares Mean
1326911|NCT02152371|Secondary|Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)|The LS means of the 7-point SMPG change from baseline to primary endpoint at week 28 was measured using a MMRM analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline SMPG as covariate.|Baseline, 28 Weeks|All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline SMPG data.|||mg/dL||Standard Error|Least Squares Mean
1326951|NCT02151461|Secondary|Change in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)|Effect on insulin sensitivity across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of HOMA-IR. Some of the samples collected were not viable and could not be included in the analysis. So, the total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.|||HOMA units||Standard Deviation|Mean
1326912|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)|FSG is a test to determine glucose levels after an overnight fast. LS means FSG change from baseline to primary endpoint at week 28 was calculated using a mixed effects model for repeated measures (MMRM) analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline FSG as covariate.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline FSG data.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
1326913|NCT02152371|Primary|Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post- baseline HbA1c.|||percentage of change||Standard Error|Least Squares Mean
1326914|NCT02152007|Other Pre-specified|Standardized Photographs|An expert in the disease who is blinded to the study treatment will read the photographs of the callus area taken at each study visit. The reader will assess changes to the calluses based on criteria such as blisters, cracks, small/large size, and red or bloody spots on the callus. Change in calluses will be reported for both the right and left foot.|Each study visit over 39 weeks|||||||
1326915|NCT02152007|Other Pre-specified|Investigator Assessment of Local Tolerability|Investigator assessment of local tolerability at the application sites on the plantar surfaces will be evaluated by the Investigator according to a 4-point scale (0, 1, 2, or 3; none to severe) with regard to: erythema, pruritis, stinging/burning, and crusting/erosion|Prior to application of study drug and within 15-45 minutes after application of study drug at each visit for 39 weeks||||units on a scale||Standard Deviation|Mean
1326916|NCT02152007|Secondary|Daily Assessments Recording in the PC Measurement Diary||Weekly for 39 weeks|||||||
1326917|NCT02152007|Secondary|Weekly Assessments Recorded in the PC Quality of Life Index|Patient-reported weekly assessment in the PC Quality of Life Index|Weekly for 39 weeks|||||||
1326918|NCT02152007|Primary|Evaluation of Systemic Absorption Through Measurement of Serum Sirolimus Trough Levels|The primary outcome measure for this Phase 1b safety study is evaluation of system absorption through measurement of serum sirolimus trough levels. The limit of detection of the assay was 2.0 ng/mL.|Two weeks and every 1-2 months for 24 weeks or within 2 weeks after the last dose of study drug|Starting at week 13, visit 4, there were only 14 participants with available data.|||participants|||Number
1326919|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Food Effect (FE)|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration||||% of subject with TEAEs related to SM|||Number
1326920|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Multiple Ascending Dose (MAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|No drug-related TEAEs were reported for the dose levels of 50 mg md and 400 mg md.|||% of subject with TEAEs related to SM|||Number
1326921|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Single Ascending Dose (SAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration||||% of subject with TEAEs related to SM|||Number
1326922|NCT02151981|Other Pre-specified|Number of Deaths|Total number of deaths at the time of the analysis|From randomisation until death, up to 19 months (at the time of analysis).|Full Analysis Set (all randomised patients)|||Number of participants|||Number
1326923|NCT02151981|Secondary|Tumour Shrinkage by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||% change from baseline||Standard Deviation|Mean
1326952|NCT02151461|Secondary|Change in Hemoglobin A1c (HbA1c)|Changes in HbA1c which is a marker of long-term glucose control was assessed.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 28 Evaluable Population (n=73)|||percent||Standard Deviation|Mean
1326924|NCT02151981|Secondary|Disease Control Rate (DCR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD at >=6 weeks, prior to any progressive disease (PD).|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||% of participants|||Number
1326925|NCT02151981|Secondary|Duration of Response (DoR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||months||95% Confidence Interval|Median
1326926|NCT02151981|Secondary|Objective Response Rate (ORR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||% of participants|||Number
1326927|NCT02151981|Primary|Progression Free Survival (PFS) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||Months|Events|95% Confidence Interval|Median
1326928|NCT02151851|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24|The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. Each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3. A total score is computed from the item scores using the scoring rules provided by the index's author. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline.|Baseline, Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~LOCF = last observation carried forward. Only subjects with available HAQ-DI scores at week 24 were included."|||units on a scale||Standard Deviation|Mean
1326929|NCT02151851|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 24|The assessments are based on a 70 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 70 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~NRI = non-responder imputation."|||percentage of participants|||Number
1326930|NCT02151851|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 24|The assessments are based on a 50 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 50 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~NRI = non-responder imputation."|||percentage of participants|||Number
1326931|NCT02151851|Primary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 24|The assessments are based on a 20 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~NRI = non-responder imputation."|||percentage of participants|||Number
1326953|NCT02151461|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose for the fixed dose leucine and metformin combination treatments A, B and C was evaluated.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of Fasting Plasma Glucose change from day 1-day 28 Evaluable Population (n=73)|||mg/dL||Standard Deviation|Mean
1326932|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326933|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326934|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326935|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326936|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326937|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1326938|NCT02151786|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1326939|NCT02151786|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1326940|NCT02151773|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.|||participants|||Number
1326941|NCT02151773|Primary|Number of Participants With Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, adverse drug reactions were assessed as endpoint.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.|||participants|||Number
1326958|NCT02151253|Secondary|Mean Number of Naps/Day|measurements are for the preceding week|week 4 of each phase.||||naps per day||Standard Deviation|Mean
1326942|NCT02151643|Secondary|Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms.|Day 1 to Day 29|Safety Set|||score on a scale||Standard Deviation|Mean
1326943|NCT02151643|Secondary|Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3–5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2).|Day 1 to Day 29|ITT population.|||mg^2/dL^2||Standard Deviation|Mean
1326944|NCT02151643|Secondary|Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.|Day 1 to Day 29|ITT population.|||percent||Standard Deviation|Mean
1326945|NCT02151643|Secondary|Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.|Day 1 to Day 29|ITT population.|||ng/mL||Standard Deviation|Mean
1326946|NCT02151643|Secondary|Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.|Day 1 to Day 29|ITT population.|||g/dL||Standard Deviation|Mean
1326947|NCT02151643|Primary|Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory.|Day 1 to Day 29|Intent-to-Treat (ITT) population.|||mg/dL||Full Range|Mean
1326948|NCT02151461|Secondary|Change From Baseline to Day 28 in Fasting Plasma Insulin Concentration|Effect on fasting plasma insulin concentrations across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment was evaluated.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of Plasma Insulin AUC and Incremental AUC change from day 1-day 28 Evaluable Population (n=73). Some collected were not viable. So, the total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.|||h*uIU/mL||Standard Deviation|Mean
1326949|NCT02151461|Secondary|Plasma Insulin Absolute and Incremental Meal Tolerance Test Area Under the Curve (AUC) 0-2hr|Change in meal tolerance test insulin area under the curve (0-2 hr) from Day 1 to Day 28 for fixed-dose leucine and metformin combination treatments.|Baseline,Day 28|Mixed Model Inferential Statistical Analysis of Plasma Insulin AUC and Incremental AUC change from day 1-day 28 Evaluable Population (n=73). Some samples collected were not viable. The total samples collected were still the same but since they couldn't included in the analysis, exact number analyzed is referenced.|||h*ulU/ml||Standard Deviation|Mean
1326950|NCT02151461|Secondary|Change In 7-Point Glucose Profiles|The meal induced glucose change in pre-meal and post-meal glucose were measured 7 times during the day. Subjects self-monitored blood glucose (preprandial and postprandial) concentrations at least 7 times, including before and 1 to 2 hours after breakfast, lunch, dinner, and snacks). For each study day, the pre-meal values from the 7 point test for each subject were averaged to generate a single pre-meal glucose value. Similarly, for each study day the post-meal values from the 7-point test for each subject were averaged to generate a single post-meal glucose value. The average change from baseline (i.e., [(Mean Pre/Post-meal value at Day 28 - Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 21- Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 7- Mean Pre/Post-meal value at Baseline)]/ 3) over multiple time points listed in Time Frame. The mean pre-meal and post-meal values for baseline, day7, day 21 and day28 were used for comparison.|Baseline, Day 7, Day 21, Day 28|Mixed Model Inferential Statistical Analysis of 7 point glucose change from day 1-day 28 Evaluable Population (n=73). Some of the samples collected were not viable and could not be included in the analysis. The total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.|||mg/dL||Standard Deviation|Mean
1326959|NCT02151253|Secondary|Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)|Scale consists of a 7 point likert rating scale where the anchors were 1= ”normal”; 2= ”borderline sleepiness”; 3= ”mild sleepiness”; 4= ”moderate sleepiness”; 5= ”marked sleepiness”; 6= ”severe sleepiness”; and 7= ”among the most extremely sleepy individuals”|week 4, of each phase||||units on a scale||Standard Deviation|Mean
1326960|NCT02151253|Primary|Change From Baseline in Epworth Sleepiness Scale [ESS]|Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4.|Baseline, Week 4 of each phase||||units on a scale||Standard Deviation|Mean
1326961|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326962|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326963|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326964|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326965|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326966|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 – 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326967|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 8|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326968|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 4|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326969|NCT02151058|Primary|Lobene Stain Index Composite Score at Day 15|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1326970|NCT02150954|Secondary|Neonatal Outcome: Late Fetal Heart Rate Decelerations|Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.|during admission for delivery, up to approximately 4 days||||neonates|||Number
1326971|NCT02150954|Secondary|Neonatal Outcome: Placental Abruption|number of participants with placental abruption|during admission for delivery, up to approximately 4 days||||participants|||Number
1326972|NCT02150954|Secondary|Neonatal Outcome: Birthweight||at time of birth (0 to 1 hour)||||gram||Standard Deviation|Mean
1326975|NCT02150954|Secondary|Time to Active Labor|Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.|during admission for delivery, up to approximately 4 days||||hours||Inter-Quartile Range|Median
1326976|NCT02150954|Secondary|Rate of Cesarean Delivery|Number of participants having a cesarean delivery|during admission for delivery, up to approximately 4 days||||participants|||Number
1326977|NCT02150954|Primary|Time to Delivery|Time from foley balloon placement until neonate delivery|foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)||||hours||Inter-Quartile Range|Median
1326978|NCT02150954|Primary|Time to the Second Stage of Labor|The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.|foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)||||hours||Inter-Quartile Range|Mean
1326979|NCT02150499|Secondary|Number and Percentage of Subjects Determined to be Stabilized After Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1|||||||
1326980|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes|||||||
1326981|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes|||||||
1326982|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1|||||||
1326983|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1|||||||
1326984|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1||||Number of Discontinuations|||Number
1326985|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1||||Number of Serious Adverse Events|||Number
1326986|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1||||Number of Adverse Events|||Number
1326987|NCT02150460|Primary|Pain Score for Cataract Surgery|Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes||||units on a scale||Standard Deviation|Mean
1326988|NCT02150460|Secondary|Duration of Cataract Surgery (Minutes)|Time interval from conjunctival incision to application of eye pad|At the end of surgery||||minutes||Standard Deviation|Mean
1326989|NCT02150460|Secondary|Acceptability of the Anaesthetic Block to the Subject|Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye|25 minutes||||participants|||Number
1326990|NCT02150460|Secondary|Surgeon Satisfaction Score for Local Anaesthetic Block|Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)|20 minutes||||units on a scale||Full Range|Median
1326991|NCT02150460|Secondary|Total Number of Injections|Total number of injections required to achieve an akinesia score of <4|15 minutes||||injections||Standard Deviation|Mean
1326992|NCT02150460|Secondary|Volume of Anaesthetic Drug (ml)|Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery|10 and 15 minutes||||milliliters||Standard Deviation|Mean
1326993|NCT02150460|Primary|Pain Score for Local Anaesthetic Injection|Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes||||units on a scale||Standard Deviation|Mean
1326994|NCT02150460|Primary|Complications of Local Anaesthetic Injection|"Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc~Local complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc"|0,10 and 15 minutes||||participants|||Number
1326995|NCT02150460|Primary|Supplementary Injection(s)|After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later|5 minutes||||participants|||Number
1326996|NCT02150460|Primary|Time Taken to Achieve Adequate Akinesia|Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of <4 and was evaluated at 10 and 15 minutes.|10 minutes and 15 minutes||||participants|||Number
1326997|NCT02150343|Secondary|Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo|The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 50-52 weeks after randomisation.|Weeks 50 to 52 after randomisation||||Days||Standard Error|Least Squares Mean
1326998|NCT02150343|Secondary|Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo|"Mean RMS (Rescue medication score) in HDM-SPIRE treatment groups compared with placebo groups.~The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 50-52 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
1326999|NCT02150343|Secondary|Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo|"TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
1327000|NCT02150343|Secondary|Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo|"Mean daily Total Non-nasal Symptom Score (TNNSS) in HDM-SPIRE treatment groups compared to placebo. TNNSS was the sum of all the non-nasal symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TNNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
1327001|NCT02150343|Secondary|Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo|"Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in HDM-SPIRE treatment groups compared with placebo.~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
1327002|NCT02150343|Secondary|Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline|"A Global Impression of Change in Rhinoconjunctivitis Symptoms assessment was completed by subjects at the final follow-up visit. Subjects rated their overall allergy symptoms at the end of the study relative to baseline on a seven-point scale as follows:0. very much better; 1. moderately better; 2. a little better; 3. unchanged; 4. a little worse; 5. moderately worse; 6. very much worse.~For reporting the individual categories were grouped as follows: moderately or very much better; any improvement; no change and any worsening. Subjects could therefore be reported in more than group and the total number reported does not match the overall number of participants analysed."|Weeks 50 to 52 after randomisation|The overall number of participants analysed represents the number of subjects that completed the assessment, not all subjects that completed the study (651) completed the Clinical Global Impression of Change (633).|||Participants|||Count of Participants
1327003|NCT02150343|Secondary|Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo|"The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (50-52 weeks after randomisation).~RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). Questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six.~A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
1327004|NCT02150343|Primary|Combined Score of Symptoms and Allergy Medication|"The primary endpoint was mean Combined Score (CS) over a 3 week period (50-52 weeks after randomisation) in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. A higher score indicated more severe symptoms or greater use of allergy rescue medication and thus a low score indicated a better outcome.~CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing, blocked nose and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe); TRSS was divided by the number of symptoms (8) to provide an average score per symptom of 0-3.~The RMS score ranged from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
1327005|NCT02150213|Primary|Incidence of Uterine Endometrial Stromal Sarcomas|Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)|||Participants|||Number
1327147|NCT02146352|Primary|Safety/Adverse Event Outcome 4|Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent migration/dislodgement could be assessed|||percentage of patients|||Number
1327006|NCT02150213|Primary|Incidence of Adrenal Cortical Adenomas|Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full analysis Set: included all patients who signed informed consent to enter the study|||Particpants|||Number
1327007|NCT02150109|Secondary|Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from subjects WITH and WITHOUT diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour||||Number who strongly agree,agree,neutral|||Number
1327008|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.|||Blood glucose results within +/- 20%|||Number
1327009|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.|||Blood glucose results within +/- 20%|||Number
1327010|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.|||Blood glucose results within +/- 20%|||Number
1327011|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.|||Blood glucose results within +/- 15%|||Number
1327012|NCT02150109|Secondary|Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from persons WITH diabetes (329) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour||||number who strongly agree,agree,neutral|||Number
1327013|NCT02150109|Secondary|Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|326 (329-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. One subject had no BG result obtained by study staff. One subject's staff-obtained BG result was not evaluable due to protocol deviation.|||Blood glucose results within 15mg/dL/15%|||Number
1327014|NCT02150109|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|318 (329-11) Blood glucose results were analyzed. Eleven (11) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.|||Blood glucose results within 15mg/dL/15%|||Number
1327030|NCT02149264|Secondary|Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.|||ng/dL||Standard Deviation|Mean
1327015|NCT02150109|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|324 (329-5) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Three subjects did not obtain meter BG result after three attempts.|||Blood glucose results within 15mg/dL/15%|||Number
1327016|NCT02150044|Secondary|Tube Retention|Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|1 week||||ears|Participants||Number
1327017|NCT02150044|Secondary|Procedure Success|Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)||||participants|||Number
1327018|NCT02150044|Primary|Ear Outcome Success|Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)||||ears|Participants||Number
1327019|NCT02149875|Secondary|Barthel Index Score|Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence|At 11-day and 21-day after therapy||||units on a scale||Standard Deviation|Mean
1327020|NCT02149875|Primary|National Institutes of Health Stroke Scale Score|Scores range from 0 to 42, with higher scores indicating increasing severity|At 11-day and 21-day after therapy||||units on a scale||Standard Deviation|Mean
1327021|NCT02149342|Other Pre-specified|Clearance of Field Cancerization in Hyperspectral Images|Data not collected|3 months|||||||
1327022|NCT02149342|Secondary|Pain Assesment (Visual Analog Scale)|Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed.|12 hours||||Mean maximal pain VAS score||Full Range|Mean
1327023|NCT02149342|Secondary|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe.|One week||||participants|||Number
1327024|NCT02149342|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|Baseline, 3 months||||percentage of lesions in complete respon|Participants|Full Range|Mean
1327025|NCT02149342|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|Baseline, 3 months|One patient was excluded from the histological analysis because one biopsied lesion clinically taken as an AK appeared histologically to be seborrheic eczema.|||percentage of complete histological clea|Participants|Full Range|Mean
1327026|NCT02149303|Primary|Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization|"Proportion of Index events by anatomic location and type are presented. The categories of Unknown and Other presented below correspond to, Unknown: Unknown location of bleeding met the criteria for major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).~Other: Other types of bleeding represent a combined category of all other locations of bleeding whose incidence was <1.7%."|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites|||Percentage of events|||Number
1327027|NCT02149303|Primary|Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release|Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites|||Percentage of participants|||Number
1327028|NCT02149303|Primary|Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.|Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites|||Percentage of participants|||Number
1327029|NCT02149264|Secondary|Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.|||ng/dL||Standard Deviation|Mean
1333294|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for itching.|24 hours||||Participants|||Count of Participants
1327031|NCT02149264|Secondary|Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to adverse event after Day 14 visit and not included in the analysis.|||hr||Full Range|Median
1327032|NCT02149264|Secondary|Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.|||ng*hr/dL||Standard Deviation|Mean
1327033|NCT02149264|Secondary|Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone|A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.|||ng/dL||Standard Deviation|Mean
1327034|NCT02149264|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Score|"Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains:~PCS:~Physical Functioning (2 items, questions 2-3)~Role-Physical (2 items, questions 4-5)~Bodily Pain (1 item, question 8)~General Health (1 item, question 1)~MCS:~Vitality (1 item, question 10)~Social Functioning (1 item, question 12)~Role-Emotional (2 items, questions 6-7)~Mental Health (2 items, questions 9 and 11)~PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||units on a scale||Standard Deviation|Mean
1327035|NCT02149264|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score|"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain (categorical in nature) are scored from 1-4. The scores are converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue)."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||units on a scale||Standard Deviation|Mean
1327036|NCT02149264|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Score|"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:~Erectile function (6 items, questions 1-5 and 15) (Score range:1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||units on a scale||Standard Deviation|Mean
1327037|NCT02149264|Secondary|The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|At 14, 35 and 56|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||percentage of subjects|||Number
1327038|NCT02149264|Primary|The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL|The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.|At Day 90|Full Analysis Set (FAS) population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||percentage of subjects||95% Confidence Interval|Number
1327091|NCT02148107|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related Adverse events (AEs)|From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days|Treated set|||Percentage of participants|||Number
1327039|NCT02149108|Secondary|Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment|Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Percentage of participants|||Number
1327040|NCT02149108|Secondary|Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment|Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Percentage of participants|||Number
1327041|NCT02149108|Primary|Overall Survival (OS)|"OS was defined as the time from randomisation to the time of death from any cause.~Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm."|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Months||95% Confidence Interval|Median
1327042|NCT02149108|Primary|Progression-Free Survival (PFS) by Central Review Assessment|"PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first.~Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm."|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Months||95% Confidence Interval|Median
1327043|NCT02148809|Other Pre-specified|Change IN Plasma Volume PV|"An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370– 1,295 kBq [10–30 mCi]) in saline.~Measurement was performed directly before surgery in the holding area and 6 hours after surgery.~Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate."|preoperative and 6 hours postoperatively||||ml||Standard Deviation|Mean
1327044|NCT02148809|Primary|Change in Total Blood Volume|The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.|preoperatively and 6 hours postoperatively||||ml||Standard Deviation|Mean
1327045|NCT02148718|Secondary|Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12|The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI < 5) at Week 12.|Up to Week 12|ITT population|||percentage of participants|||Number
1327046|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||mg/dL||Standard Deviation|Mean
1327047|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||ratio||Standard Deviation|Mean
1327048|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||sec||Standard Deviation|Mean
1327049|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||mg/kg||Standard Deviation|Mean
1327050|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||U/L||Standard Deviation|Mean
1327051|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||mm/1h||Standard Deviation|Mean
1327092|NCT02147899|Secondary|Number of Patients With a Normal Nugent Score|The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.|Study Days 21-30|mITT|||Participants|||Count of Participants
1327052|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||cellsx10^6/uL||Standard Deviation|Mean
1327053|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||cellsx10^3/uL||Standard Deviation|Mean
1327054|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||% volume||Standard Deviation|Mean
1327055|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time [aPTT], international normalized ratio [INR], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||g/dL||Standard Deviation|Mean
1327056|NCT02148718|Secondary|Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12|The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
1327057|NCT02148718|Secondary|Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12|The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
1327058|NCT02148718|Secondary|European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12|"The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components:~The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0.~The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively.~A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented."|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
1327059|NCT02148718|Secondary|European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12|"The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL) and consists of 2 components:~The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0.~The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively.~A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented."|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
1327060|NCT02148718|Secondary|Percentage of Participants With Clinical Remission at Weeks 2 and 4|Clinical remission defined as HBI < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.|Weeks 2 and 4|ITT population|||percentage of participants||95% Confidence Interval|Number
1327061|NCT02148718|Secondary|Percentage of Participants With Clinical Response at Week 1|Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.|Week 1|ITT population|||percentage of participants||95% Confidence Interval|Number
1327062|NCT02148718|Primary|Percentage of Participants With Clinical Response at Day 4|Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.|Day 4|Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1327063|NCT02148588|Secondary|Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire|"Composite scores on NPSI (Neuropathic Pain Symptom Inventory) questionnaire before and 40 minutes after the peripheral nerve block.~The NPSI assesses participant ranking of specific neuropathic pain descriptors, each ranked on a 0-10 scale, where 0 represents no burning/squeezing/electric shocks (etc), and 10 represents worst burning/squeezing/electric shocks (etc).~The scores on individual questions are grouped (averaged) into the three following subscales (each subscale scores ranging from 0 to 10):~Burning pain~Paroxysmal pain~Paresthesia/dysesthesia"|baseline and 40 min||||units on a scale||Standard Deviation|Mean
1327064|NCT02148588|Secondary|Change in the Intensity of Brush Sensation|"The intensity of brush sensation (application of SENSELab Brush-05) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful brushing sensation); lower scores represent reduced sensitivity (0=no brushing sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Standard Deviation|Mean
1327065|NCT02148588|Secondary|Change in the Intensity of Pinprick Sensation|"The intensity of pinprick sensation (application of Semmes-Weinstein monofilament #6.1, ~100g target force) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful sharp); lower scores represent reduced sensitivity (0=no pricking sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Standard Deviation|Mean
1327066|NCT02148588|Secondary|Change in the Intensity of Warm Sensation|"The intensity of warm sensation (application of roller heated up to 40 degrees Celsius) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful hot); lower scores represent reduced sensitivity (0=no warmth sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Standard Deviation|Mean
1327067|NCT02148588|Secondary|Change in the Intensity of Cold Sensation|"The intensity of cold sensation (application of roller cooled down to 20 degrees Celsius) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful cold); lower scores represent reduced sensitivity (0=no cold sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Inter-Quartile Range|Median
1327068|NCT02148588|Primary|Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block.|"Reduction in spontaneous pain intensity in the painful extremity from baseline to 30 minutes after a peripheral nerve block.Spontaneous pain intensity was measured on 0-10 numerical rating scale (NRS), where 0 represents no pain, and 10 represents worst pain imaginable"|baseline and 30 minutes|ITT|||units on a scale||Inter-Quartile Range|Median
1327069|NCT02148523|Secondary|Morisky Medication Adherence Scale (MMAS)|"The secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: “Yes” = 0 and “No” = 1 (and 0 = 0 and 1-4 = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: 0 = High Adherence; 1-2 = Medium Adherence; 3-8 = Low Adherence."|90 days||||units on a scale||Inter-Quartile Range|Median
1327070|NCT02148523|Primary|Statin Adherence|The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.|90 days||||percentage of correct statin doses||Standard Deviation|Mean
1327071|NCT02148445|Secondary|Cotinine (Continued Smokers Only)|Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded|||ng/mg creatinine||Standard Deviation|Geometric Mean
1327072|NCT02148445|Secondary|Carcinogen Exposure (Continued Smokers Only)|Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded|||pg/mg creatinine||Standard Deviation|Geometric Mean
1327073|NCT02148445|Secondary|Carbon Monoxide Exposure (Continued Smokers Only)|Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis, non-smokers at each time point excluded|||parts per million (ppm)||Standard Deviation|Mean
1327074|NCT02148445|Secondary|Average Cigarettes Per Day (Continued Smokers Only)|"Average number of cigarettes per day over one year, among continued smokers. All participants were asked During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day? at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking."|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis, non-smokers at each time point excluded|||cigarettes per day||Standard Deviation|Mean
1327075|NCT02148445|Secondary|Cotinine|Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis|||ng/mg creatinine||Standard Deviation|Geometric Mean
1327093|NCT02147899|Secondary|Number of Patients With Therapeutic Cure|Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.|Study Days 21-30|||||||
1327076|NCT02148445|Secondary|7-day Abstinence|"Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days? They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO <=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table."|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis. Missing responses were coded as smokers.|||Participants|||Count of Participants
1327077|NCT02148445|Secondary|Cardiac-related Hospital Visits|Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||Participants|||Count of Participants
1327078|NCT02148445|Secondary|Respiratory-related Hospital Visits|Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||Participants|||Count of Participants
1327079|NCT02148445|Secondary|Respiratory Symptoms|Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||units on a scale||Standard Deviation|Mean
1327080|NCT02148445|Secondary|Respiratory Function|Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.|Month 12|n=4 deceased participants excluded from analysis. Participants with missing data excluded.|||% of predicted||Standard Deviation|Mean
1327081|NCT02148445|Secondary|Carcinogen Exposure|Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis.|||pg/mg creatinine||Standard Deviation|Geometric Mean
1327082|NCT02148445|Secondary|Carbon Monoxide Exposure|Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||parts per million (ppm)||Standard Deviation|Mean
1327083|NCT02148445|Secondary|Average Cigarettes Per Day|"Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?"|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||cigarettes per day||Standard Deviation|Mean
1327084|NCT02148445|Secondary|Quit Attempts|Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis.|||number of quit attempts||Standard Deviation|Mean
1327085|NCT02148445|Secondary|Sustained Abstinence|"6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have 6-month sustained abstinence."|Month 6 through Month 12|n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.|||Participants|||Count of Participants
1327086|NCT02148445|Primary|Smoking Abstinence (Point Prevalent)|7-day point prevalent abstinence at 12 months, confirmed by exhaled CO <=10|Month 12|n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.|||Participants|||Count of Participants
1327087|NCT02148107|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
1327088|NCT02148107|Secondary|AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
1327089|NCT02148107|Secondary|Cmax (Maximum Measured Concentration of the Analyte Inplasma)|"Cmax (maximum measured concentration of the analyte inplasma).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
1327090|NCT02148107|Secondary|AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)|"AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
1327095|NCT02147899|Primary|Cure of Bacterial Vaginosis|"Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH Whiff test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)"|Study Days 21-30|mITT|||Participants|||Count of Participants
1327096|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 12||||units on a scale||Standard Deviation|Mean
1327097|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 8||||units on a scale||Standard Deviation|Mean
1327098|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 4||||units on a scale||Standard Deviation|Mean
1327099|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 12||||units on a scale||Standard Deviation|Mean
1327100|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 8||||units on a scale||Standard Deviation|Mean
1327101|NCT02147691|Secondary|Visual Analog Scale (VAS)|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 4||||units on a scale||Standard Deviation|Mean
1327102|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 12||||units on a scale||Standard Deviation|Mean
1327103|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 8||||units on a scale||Standard Deviation|Mean
1327104|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 4||||units on a scale||Standard Deviation|Mean
1327105|NCT02147691|Secondary|Lesion Counts||Week 12||||lesions||Standard Deviation|Mean
1327106|NCT02147691|Secondary|Lesion Counts||Week 8||||lesions||Standard Deviation|Mean
1327107|NCT02147691|Secondary|Lesion Count||Week 4||||lesions||Standard Deviation|Mean
1327108|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 12||||units on a scale||Standard Deviation|Mean
1327109|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 8||||units on a scale||Standard Deviation|Mean
1327110|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 4||||units on a scale||Standard Deviation|Mean
1327111|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.|Baseline||||units on a scale||Standard Deviation|Mean
1327112|NCT02147691|Secondary|Erythema Visual Analog Scale (VAS) Assessment (Subject)|Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)|Baseline||||units on a scale||Standard Deviation|Mean
1327113|NCT02147691|Secondary|Clinician's Erythema Assessment|Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.|Baseline||||units on a scale||Standard Deviation|Mean
1327114|NCT02147691|Secondary|Lesion Counts|The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line|Baseline||||lesions||Standard Deviation|Mean
1327115|NCT02147691|Primary|Investigator Global Assessment (IGA) at Baseline|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Baseline|Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis.|||units on a scale||Standard Deviation|Mean
1327116|NCT02147587|Other Pre-specified|Number of Participants With Clinically Significant Abnormal Laboratory Parameters|Participants with the following abnormalities were discontinued from the study: 2 sequential absolute neutrophil counts (ANC) <1000/mm^3; 2 sequential hemoglobin values <8.0 g/dL or decreases of >30% from baseline value; 2 sequential absolute lymphocyte count <500/mm^3; 2 sequential platelet counts <75,000/mm^3; 2 sequential alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations >=3 times the upper limit of normal (X ULN) with a total bilirubin value >=2X ULN, elevated international normalized ratio (INR), or accompanied by signs/symptoms consistent with hepatic injury; 2 sequential ALT or AST elevations >=5X ULN regardless of total bilirubin or accompanying symptoms; confirmed increases in serum creatinine (SCr) >50% over the average of screening and baseline values; a confirmed positive urine pregnancy test or refusal to use appropriate contraception in a woman of childbearing potential.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
1327117|NCT02147587|Other Pre-specified|Number of Participants With Clinical Herpes Zoster Events by Severity|Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
1327118|NCT02147587|Other Pre-specified|Number of Participants With Zoster Vaccine-Related AEs by System Organ Class|Zoster vaccine-related AEs included General Disorders and Administration Site Conditions (injection site erythema, pain, pruritis, rash, swelling; vaccination site erythema, pruritus, rash), Infections and Infestations (disseminated herpes zoster), and Musculoskeletal and Connective Tissue Disorders (myalgia). All zoster vaccine-related AEs were mild, except for the herpes zoster AE classified under Infections and Infestations, which was moderate in severity.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
1327119|NCT02147587|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 16 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
1327120|NCT02147587|Secondary|Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12|VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=)1.5 was defined as a responder.|Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||percentage of participants||80% Confidence Interval|Number
1327121|NCT02147587|Secondary|Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12|The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.|Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||[gp]ELISA units/mL||80% Confidence Interval|Geometric Mean
1327122|NCT02147587|Secondary|Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12||Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||fold rise||80% Confidence Interval|Geometric Mean
1327123|NCT02147587|Primary|Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4|VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).|Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||fold rise||80% Confidence Interval|Geometric Mean
1327124|NCT02147561|Secondary|Physician Global Assessment of Outcome on a 3-Point Scale|Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment|||Patients|||Number
1327125|NCT02147561|Secondary|Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment|||Scores on a Scale||Standard Deviation|Mean
1327126|NCT02147561|Primary|Percentage of Patients With Adverse Events|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|28 Days|Safety Population: patients enrolled in the study who received study drug|||Percentage of Patients|||Number
1327127|NCT02147522|Other Pre-specified|Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score|The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.|baseline, 6- and 12-month follow-ups|Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).|||units on a scale||Standard Deviation|Mean
1327128|NCT02147522|Secondary|Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)|The Physical Component Summary (PCS) is a norm-based score standardized to the general U.S. population with a mean of 50, and a SD of 10. Scores range from 0 to 100, a higher score indicating better physical health.|baseline, 6- and 12-month follow-ups|Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).|||units on a scale||Standard Deviation|Mean
1327129|NCT02147522|Primary|Response Rate – 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline|"The PHQ-9, which establishes provisional depressive disorder diagnosis as well as grades depressive symptom severity, will be obtained from all study subjects at recruitment and during the four waves of data collection (up to 12 months). The PHQ-9 scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day), with possible scores ranging from 0 to 27, with cut points of 5,10,15, and 20 representing the thresholds for mild, moderate, moderately severe, and severe depression. A validated Spanish version of the PHQ-9 will be used. Clinically meaningful improvement of depressive symptoms was assessed as a ≥50% score reduction since baseline assessment."|6- and12-month follow-ups|Analyses for hypothesis testing related to the evaluation of AHH effects were carried out according to the intention-to-treat rule consistent with standard practice in clinical trials.|||Participants|||Count of Participants
1327148|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 3|Freedom from surgery for access-site related perforation|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
1327934|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||g/dL||Standard Deviation|Mean
1327130|NCT02147288|Primary|Post-operative Seroma Formation|Quantitative assessment of fluid collection in pre-defined anatomic regions will be performed via ultrasound examination approximately two weeks following removal of drains (either JP or NPWT-associated)|Two weeks following drain removal|Among 21 completers (standard of care group); one outlier was excluded from the analysis; 20 subjects were analyzed. Among 22 completers (experimental group), one outlier and 1 who did not have an ultrasound (i.e., fluid was not measured) were excluded, leaving 20 subjects for analysis.|||cm^3||Full Range|Mean
1327131|NCT02147184|Other Pre-specified|The Moderating Effect of the Short Allele of the Serotonin Transporter-Linked Polymorphic Region (5HTTLPR) Gene on the Association Between SSRI Use and the Primary Outcomes||2 years||2019-12-31|12/2019||||
1327132|NCT02147184|Secondary|Cortical Thickness at 20% Radius|This is cortical thickness as measured by pQCT.|At baseline and every 4 months up to 2 years.|The figures below may be lower than the overall numbers above due to exclusions for movement artifacts and premature drop outs.|||mm||Standard Deviation|Mean
1327133|NCT02147184|Secondary|Cortical Volumetric BMD at 20% Radius||At baseline and every 4 months up to 2 years.|This was the original sample size per group but the figures below reflect attrition and data exclusion due to movement artifacts.|||mg/cm^3||Standard Deviation|Mean
1327134|NCT02147184|Secondary|Lumbar Spine Bone Mineral Density (BMD) Z-score|This is a Z-score adjusted for sex, age, race, and height.|At baseline and every 8 months up to 2 years.|This was the initial sample size per group but the figures below reflect attrition or data excluded due to artifact.|||Z-score (Age-Sex-Height-Race Specific)||Standard Deviation|Mean
1327135|NCT02147184|Primary|Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio|Bone-specific alkaline phosphatase (ng/mL) is a marker of bone formation while C-terminal telopeptide (ng/mL) is a marker of bone resorption.|At baseline and every 4 months up to 2 years.|The figures below might be less than the stated numbers above depending on availability of serum samples, the performance of the assay, and premature attrition.|||Ratio||Standard Deviation|Mean
1327136|NCT02147184|Primary|Osteocalcin to C-terminal Telopeptide Ratio|Osteocalcin (ng/mL) is a bone formation marker and C-terminal telopeptide (ng/mL) a marker of bone resorption.|At baseline and every 4 months up to 2 years.|The figures below may be lower based on availability of serum, performance of the assay, and premature attrition.|||Ratio||Standard Deviation|Mean
1327137|NCT02147184|Primary|Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius|Volumetric bone mineral density (vBMD) at the nondominant radius (4% and 20% sites) was measured, at study entry and every four months, with peripheral quantitative computed tomography (pQCT), using a Stratec XCT‐2000 scanner (Stratec, Inc., Pforzheim, Germany). Image analysis was performed using the manufacturer’s software package, version 6.0. pQCT scans compromised by movement were rejected. Quality control and calibration of the equipment were performed daily.|At baseline and every 4 months up to 2 years.|This was the starting sample size. However, the figures below reflect participant attrition and exclusion of scans due to movement artifact.|||mg/cm^3||Standard Deviation|Mean
1327138|NCT02147184|Primary|Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race)|Whole-body dual energy x-ray absorptiometry (DXA) scan was obtained using a Hologic QDR DELPHI-4500A unit or a Hologic Discovery A unit (Hologic, Inc, Bedford, MA). The two DXA units were cross-calibrated.|At baseline and every 8 months up to 2 years.|These are the starting sample size but the figures below reflect participant attrition.|||Z score (age-sex-height-race specific)||Standard Deviation|Mean
1327139|NCT02147093|Primary|Near LogMAR Visual Acuity|Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
1327140|NCT02147093|Primary|Distance LogMAR Visual Acuity|Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
1327141|NCT02146599|Primary|Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery|Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.|Baseline and 1 week|Of the 295 participants who provided data for this analysis (monofocal participants , n=138; accommodating participants, n=34; and multifocal participants, n=123), corrective visual aids (i.e., spectacles, contact lenses) post intraocular lens (IOL) surgery were required by 88 participants.|||participants|||Number
1327142|NCT02146482|Secondary|Change in Pain in Other Body Parts|The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. This data was not analyzed due to the focus of the project on lower back pain.|At the conclusion of each work day for 12 weeks and 8 weeks later|||||||
1327143|NCT02146482|Primary|Change in Back Pain|The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to agree or disagree with 24 different statements related to their back pain. The end score is the sum of the agreed statements. The score ranges from 0 (no disability) to 24 (maximum disability).|Baseline (Week 1) and Follow-Up (Week 18)||||units on a scale||Full Range|Median
1327144|NCT02146352|Secondary|Technical Success Outcome Measure 2|Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps|30 or 60 Day Post-procedure|Per Protocol|||percentage of patients|||Number
1327145|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 6|Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
1327146|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 5|Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent was removed and tissue at site of stent implant was observed at time of removal|||percentage of patients|||Number
1327149|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 2|Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
1327150|NCT02146352|Secondary|Clinical Success Outcome Measure|Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days|30 or 60 days post-procedure|Entire patient cohort|||percentage of patients|||Number
1327151|NCT02146352|Secondary|Technical Success Outcome Measure 1|Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System|Index Procedure|Per Protocol|||percentage of patients|||Number
1327152|NCT02146352|Secondary|Lumen Patency Outcome Measure|Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.|30 and/or 60 days post-procedure|Per Protocol|||percentage of patients|||Number
1327153|NCT02146352|Secondary|Stent Retention Outcome Measure|Stent Retention: The stent must remain in place for up to 60 days|30 or 60 days post-procedure|Per Protocol Population|||percentage of patients|||Number
1327154|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 1|Freedom from access site-related bleeding requiring transfusion|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
1327155|NCT02146326|Secondary|Patient Engagement-Missed Appointments|Patient engagement was assessed by the proportion of missed appointments (when the client cancelled or did not show for a scheduled appointment divided by the total scheduled). This data was retrieved from client medical records at the agencies. Data from 3 time periods were analyzed (6 months prior to baseline through baseline, baseline to 6 months, and 6 months to 12 months). The below table illustrates the missed appointments for each time period.|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to missing data (medical records not available) and clients discontinuing treatment at their respective agency.|||appointments at mental health agency||Standard Deviation|Mean
1327156|NCT02146326|Secondary|Quality of Care Total|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.) and then refined to 22 items through data collected and analyzed in this study. This scale for clients was adapted from the one developed for staff. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327157|NCT02146326|Secondary|Quality of Care-Inattentive Care|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Inattentive care was measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327158|NCT02146326|Secondary|Quality of Care-Negative Interactions|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Negative Interactions were measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327159|NCT02146326|Secondary|Quality of Care-Person Centered Care|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Person Centered Care was measured with a subset of questions from this scale. The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327160|NCT02146326|Secondary|Client Satisfaction Questionnaire|Engagement was assessed with patient satisfaction using the Client Satisfaction Questionnaire, an 8-item satisfaction checklist (e.g., How would you rate the quality of service you have received? and, If a friend were in need of similar help, would you recommend [name of agency] to him or her?). The item scores were averaged. Scale: 1 to 4 with response text dependent upon the question (e.g., 1-Poor to 4-Excellent, 1-No, definitely not to 4-Yes, definitely, or 1-Quite dissatisfied to 4-Very satisfied).|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327161|NCT02146326|Secondary|Generalized Anxiety Disorder (GAD-7)|"Anxiety was assessed with the 7-item Generalized Anxiety Disorder (GAD-7). It can be scored continuously on a 0-21 severity scale and cutpoints have been established for estimating the probability of the 4 most common and clinically relevant anxiety disorders – generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Scale: 0 (not at all), 1 (several days), 2 (more than half the days), 3 (nearly every day)~Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of Internal Medicine. May 22 2006;166(10):1092-1097.~Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. Mar 6 2007;146(5):317-325."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327179|NCT02146326|Secondary|Confidence: Client Interaction|"Staff were asked, How confident are you that you can consistently interact with consumers/clients in a relaxed, non-judgmental way? Scale: 1 (not at all confident) to 10 (extremely confident)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327223|NCT02145468|Secondary|Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24|Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327162|NCT02146326|Secondary|Patient Health Questionnaire 9-item (PHQ-9)|"The PHQ-9 is a brief, self-report assessment. It provides a summed total score that indicates likelihood of major depressive disorder. Scores ≥10 are considered a positive screen (sensitivity 88%, specificity 88%) and also effectively measures response to treatment (<5 indicate remission, of 5-9 indicate partial response, and ≥10 indicates no response). Item scores are summed and averaged (range: 0-27). Scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 4 (Nearly every day). When problems are identified, the difficulty of those problems are rated on 4 point scale (Not difficult at all to Extremely difficult).~Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine. Sep 2001;16(9):606-613.~American Psychiatric Association. Diagnostic and statistical manual of mental disorders - Text Revision (4th ed.). Washington, DC: American Psychiatric Association; 2000."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327163|NCT02146326|Secondary|Short-Form Health Survey (SF-12)-Mental Health Functioning|"Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).~Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 –233."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327164|NCT02146326|Secondary|Short-Form Health Survey (SF-12)-Physical Health Functioning|"Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).~Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 –233."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327165|NCT02146326|Secondary|Patient Activation Measure-Mental Health (PAM-MH)-0 to 100 Scale|"Competence related to mental health management was assessed with the 13-item Patient Activation Measure-Mental Health (PAM-MH) (e.g., I know what each of my prescribed mental health medications does.). Each question was answered on a 4-point Likert-type scale: 1 (Strongly Disagree) to 4 (Strongly Agree). Higher scores=greater activation.~Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Services Research. Dec 2005;40(6 Pt 1):1918-1930."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327166|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Bonds Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the bonds subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
1327167|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Goals Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the goals subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
1327168|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Tasks Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the tasks subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
1327180|NCT02146326|Secondary|Importance: Client Interaction|"Staff were asked, How important is it for you to consistently interact with consumers/clients in a relaxed, non-judgmental way? Scale: 1 (not at all important) to 10 (extremely important)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327224|NCT02145468|Secondary|Number of Participants With CHD Death Events Through to Week 12 and Week 24|Number of participants with CHD death events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327169|NCT02146326|Secondary|Working Alliance Inventory (WAI)|"Perceived relatedness was assessed with this short form of the patient version of the WAI and is 12 items (e.g., We agree on what is important for me to work on.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
1327170|NCT02146326|Secondary|Health-Care Climate Questionnaire|"Perceived autonomy support was assessed with this 15-item scale (e.g., I am able to be open with [name] at our meetings.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)~Williams GC, McGregor HA, King D, Nelson CC, Glasgow RE. Variation in perceived competence, glycemic control, and patient satisfaction: relationship to autonomy support from physicians. Patient Education & Counseling. Apr 2005;57(1):39-45."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
1327171|NCT02146326|Secondary|Medication Adherence Rating Scale (MARS) - Medication Attitudes - 10-item|"Medication attitudes (for clients who are prescribed medications for their mental health) was rated with the MARS, a 10-item scale assessing attitudes toward medication (e.g., It is unnatural for my mind and body to be controlled by medication.). The items scores were summed and averaged (range: 0-10). Scale: 0 (No) to 1 (Yes)~Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients who reported they are not prescribed medications for their mental health, and/or missing data.|||units on a scale||Standard Deviation|Mean
1327172|NCT02146326|Secondary|Medication Adherence Rating Scale (MARS) - Medication Adherence - 4-item|"Medication adherence (for clients who are prescribed medications for their mental health) was rated with a subset of 4 items from the MARS, a 10-item scale assessing attitudes toward medication (e.g., Do you ever forget to take your medication? Are you careless at times about taking your medicine?). The item scores were summed and averaged (range: 0-4). Scale: 0 (No) to 1 (Yes)~Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients reporting they are not prescribed medications for their mental health, and/or missing data.|||units on a scale||Standard Deviation|Mean
1327173|NCT02146326|Secondary|Adult State Hope Scale|"Hope was assessed with clients using the 12-item Adult State Hope Scale (e.g., I can think of many ways to get the things in life that are most important to me.). The item scores were averaged. Scale: 1 (Definitely False) to 8 (Definitely True)~Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. Journal of Personality and Social Psychology. 1996;70(2):321 - 335."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327174|NCT02146326|Secondary|Staff Turnover|Number of staff participants who separated from their respective agency before their anticipated study completion date. The mental health agencies provided separation dates, if applicable, for staff study participants.|Measured with staff at 12 months||||Participants|||Count of Participants
1327175|NCT02146326|Secondary|Perceptions of Supervisory Support|The 19 item Perceptions of Supervisory Support Scale was used to gather information on staff's experience of interactions with their supervisors (e.g., How often did you think supervision improved your relationship with your supervisor?). The item scores were averaged. Scale: 1 (never) to 6 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327176|NCT02146326|Secondary|Quality of Care-Total|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies participating in this project and then refined to 22 items through data collected and analyzed in this study. Items were related to person or client centered care, work conscientiousness, errors, interactions with clients, and how stress affects client interactions or outcomes. The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327177|NCT02146326|Secondary|Quality of Care: Discordant Care|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Discordant Care was measured with a subset of questions from this scale (e.g., I had conflicts with clients.). The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327178|NCT02146326|Secondary|Quality of Care: Person Centered Care|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Person Centered Care was measured with a subset of questions from this scale (e.g., I felt like I was able to really show compassion to a client.). The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1333295|NCT02043704|Secondary|Time to First Rescue Narcotic|The time from the end of surgery to the time any IV narcotic is given.|24 hours||||minutes||Inter-Quartile Range|Median
1327181|NCT02146326|Secondary|Confidence: Reduce Work-Related Stress|"Staff were asked, How confident are you that you can reduce your work-related stress in your life? Scale: 1 (not at all confident) to 10 (extremely confident)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327182|NCT02146326|Secondary|Importance: Reduce Work-Related Stress|"Staff were asked, How important is it for you to reduce your work-related stress right now? This single item score was averaged. Scale: 1 (not at all important) to 10 (extremely important)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327183|NCT02146326|Secondary|Emotional Labor Scale: Genuine Emotions|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Genuine Emotions is a subset of these questions (e.g., The emotions that I express to clients are genuine). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327184|NCT02146326|Secondary|Emotional Labor Scale: Deep Acting|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Deep Acting is a subset of these questions (e.g., I try to actually experience the emotions that I must show to clients). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327185|NCT02146326|Secondary|Emotional Labor Scale: Surface Acting|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Surface Acting is a subset of these questions (e.g., I put on an act in order to deal with clients in an appropriate way). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327186|NCT02146326|Secondary|Home Life Interference With Work|"Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is family conflict with work. The measure consists of a series of statements regarding one’s work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.~Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work–family conflict. Journal of Vocational Behavior. 2000;56(2):249-276."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327187|NCT02146326|Secondary|Work Interference With Home Life|"Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is work conflict with family. The measure consists of a series of statements regarding one’s work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.~Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work–family conflict. Journal of Vocational Behavior. 2000;56(2):249-276."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327188|NCT02146326|Secondary|Turnover Intentions-Likely to Leave|"This is the second of two questions in which staff were asked about turnover intentions. Staff were asked, How likely are you to leave your job in the next six months? Scale: 1 (Not likely at all), 2 (Not very likely), 3 (Somewhat likely), 4 (Very likely)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327189|NCT02146326|Secondary|Turnover Intentions-Considered Leaving|"This is the first of two questions in which staff were asked about turnover intentions. Staff were asked, How often have you seriously considered leaving your job in the past six months? Scale: 1 (Never), 2 (Once every few months), 3 (Once a month), 4 (several times a month), 5 (Once a week), 6 (Several times a week)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327190|NCT02146326|Secondary|Job Satisfaction|"Job satisfaction was assessed with one item from the Job Diagnostics Survey: Overall, I am satisfied with my job. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)~Hackman JR, Oldham GR. The Job Diagnostic Survey: An Instrument for the Diagnosis of Jobs and the Evaluation of Job Redesign Projects. 1974."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327208|NCT02146001|Secondary|Change in Objectively-monitored Moderate-to-vigorous Physical Activity|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period.|Change from baseline to 12 weeks||||bouted minutes/week||Standard Error|Least Squares Mean
1327225|NCT02145468|Secondary|Number of Participants With CV Death Events Through to Week 12 and Week 24|Number of participants with CV death events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327191|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Personal Accomplishment|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).~Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327192|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Depersonalization|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).~Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327193|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Emotional Exhaustion|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were asked to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).~Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
1327194|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG -- Post DMPA Add Back COC HSG||HSG on OC after DMPA||||Participants|||Count of Participants
1327195|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - DMPA HSG|HSG during DMPA treatment|HSG on DMPA||||Participants|||Count of Participants
1327196|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - OC HSG|HSG during OC treatment|HSG on OC||||Participants|||Count of Participants
1327197|NCT02146248|Primary|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal|Assessment of patency at luteal phase exam|luteal phase HSG||||Participants|||Count of Participants
1327198|NCT02146248|Primary|Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular|Assessment of patency at follicular phase exam|follicular phase HSG||||Participants|||Count of Participants
1327199|NCT02146105|Secondary|Change in Biomechanical Outcomes|Participants will be asked to partake in a complete kinematic, kinetic, and electromyographic analysis of gait and static postures using floor-embedded force plates, a 9-camera motion capture system, and a wireless electromyography system. Knee adduction moment (KAM; Nm/kg), normalized electromyography to a percentage of their maximal effort (%MVIC), and muscular co-activation (%) are the variables of interest.|Week 1 and Week 13|||||||
1327200|NCT02146105|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness is assessed using a sub maximal oxygen consumption cycle ergometer test. Heart rate is monitored using a Polar Heart Rate monitor and the test is terminated upon one of two conditions: a) volitional fatigue, or b) within 10 beats of 85% of the age-predicted maximum heart rate is achieved. Values are recorded in mL/kg/min.|Week 1 and Week 13|||||||
1327201|NCT02146105|Secondary|Change in Subjective Scales|The Centre of Epidemiologic Studies Depression Scale (19-items), the Athens Insomnia Scale (8-items), and the Perceived Stress Scale (10-items) will be given to the participants to gather information on feelings of depression, sleeping patterns, and perceived stress, respectively.|Week 1 and Week 13|||||||
1327202|NCT02146105|Secondary|Change in Stair Ascent and Descent|Participants are asked to climb a standard flight of 9 stairs as quickly and safely as possible without compromising safety. Stair ascent and descent are assessed individually. Time to climb the stairs are recorded (in seconds) and averaged over two trials.|Week 1 and Week 13|||||||
1327203|NCT02146105|Secondary|Change in Timed Up and Go (TUG)|Participants are asked to raise from a standard chair, walk forward 3-metres until an orange cone is reached, walk around the cone, then walk back to the chair and sit down. The test is to be completed as quickly and safely as possible without running. The trial is repeated a second time and the quickest time (in seconds) is recorded.|Week 1 and Week 13|||||||
1327204|NCT02146105|Secondary|Change in 30-second Chair Stand|Participants are asked to cross their arms over their chest and rise and sit back down in a chair as many times as possible in 30 seconds.|Week 1 and Week 13|||||||
1327205|NCT02146105|Secondary|Change in Six Minute Walk Test (6MWT)|Participants are asked to walk as far as possible for a total of six minutes at a self-selected pace in an obstruction-free rectangular hallway. Distance traveled is recorded in metres (m).|Week 1 and Week 13|||||||
1327206|NCT02146105|Primary|Change in Knee Pain|Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.|Week 1 and Week 13|||||||
1327207|NCT02146105|Primary|Change in Knee Extensor Torque|Knee extensor torque (Newton*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.|Week 1 and Week 13||||Nm||Standard Deviation|Mean
1327222|NCT02145468|Secondary|Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24|Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327209|NCT02146001|Secondary|Change in Physical Function (Short Physical Performance Battery [SPPB])|Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best).|Change from baseline to 12 weeks||||points||Standard Error|Mean
1327210|NCT02146001|Primary|Change in Objectively Monitored Sedentary Behavior|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.|Change from baseline to 12 weeks||||hours/day||Standard Error|Least Squares Mean
1327211|NCT02145754|Primary|Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)|number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field|weekly examination during 9 weeks of cultivating for individual specimen|Each participant provided two skin samples for analysis, one sample was cultivated in MKP, the other in BSK-H media.|||culture-positive skin samples|||Number
1327212|NCT02145676|Secondary|Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1327213|NCT02145676|Secondary|Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1327214|NCT02145676|Secondary|Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1327215|NCT02145676|Secondary|Change From Baseline in Pain on an 11-Point Scale|The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = “no pain” to 10 = “pain as bad as can be imagined”. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1327216|NCT02145676|Secondary|Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1327217|NCT02145676|Primary|Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1327218|NCT02145468|Secondary|Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24|Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327219|NCT02145468|Secondary|Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327220|NCT02145468|Secondary|Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24|Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327221|NCT02145468|Secondary|Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24|Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327935|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||g/dL||Standard Deviation|Mean
1327227|NCT02145468|Secondary|Number of Participants Re-hospitalized Within 30 Days of Discharge|Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.|Within up to 30 days of post discharge|ITT Population|||Participants|||Number
1327228|NCT02145468|Secondary|Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24|Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.|Week 12, Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, in the category titles).|||Participants|||Number
1327229|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327230|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327231|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327232|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327233|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327234|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327235|NCT02145468|Secondary|Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327236|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327237|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327238|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327239|NCT02145468|Secondary|Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24|Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
1327240|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.|Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.|Week 12 and Week 24|ITT Population|||Participants|||Number
1327241|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24|Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.|Week 12 and Week 24|ITT Population|||Participants|||Number
1327242|NCT02145468|Secondary|Number of Participants With First Occurrence of MACE Through Week 24|Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.|Up to Week 24|ITT Population.|||Participants|||Number
1327243|NCT02145468|Primary|Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12|The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.|Up to 12 weeks|Intent-To-Treat (ITT) Population. ITT population comprised of all randomized participants.|||Participants|||Number
1327260|NCT02145299|Primary|Technical Success|Technical success, defined as the ability to facilitate complete intraluminal crossing of a CTO into the true distal lumen with a TruePath or a CROSSER device and/or any subsequent conventional guidewire, as confirmed by IVUS imaging|Day of operation||||percentage of participants|||Number
1327244|NCT02145390|Other Pre-specified|Identification of New Predictive and Prognostic Biomarkers for Response to Neoadjuvant Chemotherapy, and Bladder Preservation.|To perform exploratory molecular analysis to identify new predictive and prognostic biomarkers for response to neoadjuvant chemotherapy, and bladder preservation. Blood, urine and tumor tissue for muscle invasive bladder cancer. Blood, urine and tumor tissue will be collected pre and post-neoadjuvant chemotherapy, post-cystectomy or chemoradiation, and at any time point of distant metastases.|Up to 1 year Post-Treatment, About 2 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
1327245|NCT02145390|Other Pre-specified|Evaluation of Known Predictive and Prognostics Biomarkers for Complete Response to Neoadjuvant Chemotherapy and Bladder Preservation.|To evaluate known predictive and prognostic biomarkers for complete response to neoadjuvant chemotherapy and bladder preservation. Blood, urine and tumor tissue will be collected pre- and post-neoadjuvant chemotherapy, post-cystectomy or chemoradiation, and at any time point of distant metastases.|Up to 1 year Post-Treatment, About 2 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
1327246|NCT02145390|Secondary|Rate of Overall Survival in Study Participants|Rate of Overall Survival in Study Participants. Overall survival (OS) is defined as the time elapsed from the start of neoadjuvant chemotherapy until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.|Up to 3 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
1327247|NCT02145390|Secondary|Rate of Acute and Late Grade 2 or Higher Treatment-Related GU, GI and Hematologic Toxicity.|The rate of acute and late grade 2 or higher (CTCAE v4.0) treatment-related genitourinary (GU), gastrointestinal (GI) and hematologic toxicity of bladder preservation in study participants.|Up to 2 years Post-Treatment|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
1327248|NCT02145390|Secondary|Rate of Failure-Free Survival (FFS) at Two Years|The two year rate of failure free survival (FFS) in study participants. This will include locoregional recurrence, and distant metastases. FFS is defined as absence of any failures (locoregional, distant metastasis, and death) during the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy.|2 Years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
1327249|NCT02145390|Primary|Rate of Failure-Free Survival With Intact Bladder (FFSIB) in Study Participants|Rate of failure free survival with intact bladder (FFSIB) at two years in subjects undergoing bladder preservation. FFSIB is defined by the absence of any failures (locoregional, distant metastasis, and death) and bladder preservation (no radical cystectomy for any causes) after definitive chemoradiation. FFSIB is defined as the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy. For failure-free patients (without failure events and no radical cystectomy), FFSIB will be censored at the last date of documented failure-free bladder preservation (FFBP) status.|2 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
1327250|NCT02145299|Secondary|Angiographic Perforation Classification and Rate|"Evaluated in-hospital. The occurrence of any extravasation of contrast during the procedure (detected by the physician performing the procedure, or preferentially the Angiographic Core Laboratory) will be tabulated according to the standard Type 1-3 classification. Type 1 – Extraluminal crater without contrast extravasation~Type 2 – Perivascular blush without contrast jet extravasation~Type 3 – Contrast jet extravasation through frank (≥1 mm) perforation"|Day of operation|These data were not fully captured and summarized as the study was terminated.||||||
1327251|NCT02145299|Secondary|Target Vessel Revascularization|A repeat revascularization procedure (percutaneous or surgical) of the index procedure target vessel. TVR is classified as clinically-driven if the repeat intervention is driven by clinical findings (ischemic symptoms).|30 days post operation||||percentage of participants|||Number
1327252|NCT02145299|Secondary|Ankle-brachial Index (ABI)|The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm|baseline to 30 days post operation||||ratio||Standard Deviation|Mean
1327253|NCT02145299|Secondary|Target Lesion Revascularization|Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis.|30 days post operation||||percentage of participants|||Number
1327254|NCT02145299|Secondary|Index Limb Amputation|Need for limb amputation|Day of Operation through 30 days post operation||||participants|||Number
1327255|NCT02145299|Secondary|Walking Capacity|"Change in walking capacity from baseline to 30 days, measured by the Walking Impairment Questionnaire. The questionaire is a subjective measure of patient-perceived walking performance developed for individuals with peripheral arterial disease. Used to evaluate the change in walking capacity study endpoint."|Baseline and 30 days post operation|These data were not fully captured and summarized as the study was terminated.||||||
1327256|NCT02145299|Secondary|Symptomatic Improvement|Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days|Baseline, and 30 days post operation||||percentage of participants|||Number
1327257|NCT02145299|Secondary|Clinical Success|Clinical Success defined as procedure success in the absence of in-hospital all-cause death, index limb amputation above the ankle, and TLR.|Day of operation|These data were not fully captured and summarized as the study was terminated.||||||
1327258|NCT02145299|Secondary|Procedural Success|Procedural success, defined as technical success and (1) residual stenosis <50% in the treated segment (2) and improved distal flow by angiography following the procedure|Day of operation|Due to early study termination for reason unrelated to safety, rather enrollment challenges, part the Procedural Success definition required % residual stenosis which was going to be a Core Laboratory assessment to eliminate bias and maintain consistency in the analysis. With only 8 subjects enrolled, laboratory analysis was not undertaken.||||||
1327259|NCT02145299|Primary|In-hospital Safety|In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR)|Operation through 30 day follow up||||percentage of participants|||Number
1327261|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
1327262|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
1327263|NCT02145156|Primary|Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
1327264|NCT02145156|Primary|Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.|||participants|||Number
1327265|NCT02145156|Primary|Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.|||participants|||Number
1327266|NCT02145156|Primary|Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.|||participants|||Number
1327267|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
1327268|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
1327269|NCT02145156|Primary|Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
1327270|NCT02145156|Primary|Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.|||participants|||Number
1327271|NCT02145156|Primary|Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.|||participants|||Number
1327272|NCT02145156|Primary|Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.|||participants|||Number
1327572|NCT02139137|Secondary|Change in Functional Impairment; Sheehan Disability Scale|Range: 0-30; greater values indicate greater disability severity ratings|Baseline, Week 4|Data at one time point for one participant in the LIC condition are not available.|||units on a scale||Standard Deviation|Mean
1327273|NCT02144675|Primary|Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients|The clinical trial will be based on a sequential monitoring so that we will have a 90% confidence that choline magnesium trisalicylate (CMT) based modulation of NF-kB transcriptional targets and/or drug efflux occurs in at least 50% of patients.|24 hours||||Participants|||Count of Participants
1327274|NCT02144519|Secondary|Changes in Nutritional Quality of Snacks|We will assess quality of snacks served at the ASPs in terms of number of fruits and vegetables served per week. These analyses were performed at the ASP level with a sample size of 20 (10 per arm)|Spring of Year 1, Year 2, and Year 3|Direct observation of the number of days per week a fruit or vegetable was served|||Days/Week Fruit/Vegetables served|Afterschool Programs|Standard Deviation|Mean
1327275|NCT02144519|Primary|Change in Percentage of Children Meeting Physical Activity Policy|We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity. The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry. All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+. The accelerometers were distilled using 5-second epochs. When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on). Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off). Children wore the monitors for their entire attendance at the ASPs. Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior. Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.|Spring of Year 1, Year 2, and Year 3|Analysis based on the percentage of children (boys and girls, separately) achieving the 30 min MVPA standard|||Percent children achieving MVPA standard|||Number
1327276|NCT02144337|Primary|Feasibility: Number of Participants With Adverse Events|Number of participants experiencing and/or reporting adverse events.|Participants were followed from baseline to research completion||||number of participants|||Number
1327277|NCT02144337|Secondary|Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)||0 months (baseline) and 6 months (follow-up)|||||||
1327278|NCT02144337|Secondary|Change in Clinical Outcome Measures (Hba1c, Height, Weight)|Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up.|0 months (baseline) and 6 months (follow-up)|||||||
1327279|NCT02144337|Secondary|Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)||0 months (baseline) and 6 months (follow-up)|||||||
1327280|NCT02144337|Secondary|Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self‐Perceptions of Adequacy in and Predilection for Physical Activity)||0 months (baseline) and 6 months (follow-up)|||||||
1327281|NCT02144337|Primary|Feasibility: Rate of Adherence to the Intervention|Attendance at physical activity sessions and completion of activity diary Intervention group only as the Control group were not exposed to any intervention.|Participants were monitored for the duration of the STAK programme (6 weeks)||||percentage of the intervention group|||Number
1327282|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T3|Response rate at T3||||Number of participants|||Number
1327283|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T2|Response rate at T2||||number of participants|||Number
1327284|NCT02144259|Other Pre-specified|Contraceptive Satisfaction|"Satisfaction will be measured in response to the question, How satisfied are you with your current birth control method? This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from Very Good to Very Poor. Good or Very Good responses will be analyzed as having been satisfied with the method."|1 year||||percentage of women satisfied w. method|||Number
1327285|NCT02144259|Secondary|Pregnancy Rate|The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.|1 year||||number of pregnancies|||Number
1327286|NCT02144259|Primary|Weight|Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups|6 months from postpartum (baseline)||||percent weight lost||Standard Deviation|Mean
1327287|NCT02144220|Secondary|Percentage of Patients Who Felt That the Recommendations Improved Their Health||6 months||||percentage of participants|||Number
1327288|NCT02144220|Secondary|Feasibility (Descriptive)|Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.|6 months||||percentage of visits|||Number
1327289|NCT02144220|Secondary|Acceptability|- The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal >80%)|6 months||||percentage of participants|||Number
1327290|NCT02144220|Primary|Change in Quality of Life as Measured by the PDQ-39 Assessment Tool|The impact on Quality of life (QoL) as measured by the change in PDQ-39 score from baseline to 6 months. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality over the last month. 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Number
1327291|NCT02144220|Primary|Feasibility|The percent of telemedicine visits completed as scheduled. (Goal >80%)|6 months||||percentage of visits|||Number
1327292|NCT02144012|Secondary|Patient-Reported Outcomes: Number of Participants Who Completed the FACT-Taxane Questionnaire|The FACT - Taxane is a self-reported instrument which measures the HRQOL of participants receiving taxane containing chemotherapy. The FACT-Taxane consists of 16 items and was designed to assess the impact of taxane treatment-related symptoms from the participant’s perspective.|Days 1 and 8 of Cycles 1 and 2 and on the first day of each subsequent 21-day cycle thereafter as well as at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.|||Participants|||Count of Participants
1327573|NCT02139137|Secondary|Change in General Anxiety: Spielberger State-Trait Anxiety Inventory|Range: 20-80; higher scores indicate greater symptom severity|Baseline, Week 4||||units on a scale||Standard Deviation|Mean
1327293|NCT02144012|Secondary|Patient-Reported Outcomes: Number of Participants Who Completed the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire|The FACT-B (version 4) is a self-reported instrument which measures health-related quality of life (HRQOL) of participants with breast cancer.The FACT-B includes the breast cancer sub-scale (BCS) and is comprised of nine items specific to assessing patients’ HRQOL in breast cancer.|On the first Day of each 21-day Cycle (Day 1, 22, 43, etc.) and at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.|||Participants|||Count of Participants
1327294|NCT02144012|Secondary|Immunogenicity: Percentage of Positive Anti-Therapeutic Antibody (ATA) Response to Trastuzumab Emtansine||Day 1, Cycle 1 (Day 1), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Only participants with at least one post-dose sample available for ATA analysis were analyzed for this outcome measure.|||percentage of participants|||Number
1327295|NCT02144012|Secondary|Pharmacokinetics: Serum Concentrations of Study Medications|Pharmacokinetic (PK) parameters were to be determined in a subset of participants. PK samples from the first 100 Chinese participants were planned to be collected.|Day 1, Cycle 1 (Day 1), Day 1, Cycle 2 (Day 22), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)|No PK analyses were performed as no participants were enrolled from China and no samples were collected.||||||
1327296|NCT02144012|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions. Disease progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.|||months||95% Confidence Interval|Median
1327297|NCT02144012|Secondary|Objective Response Rate (ORR)|ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1. Tumor assessments were performed with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (OR) = CR + PR.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1327298|NCT02144012|Secondary|OS Truncated at 2 Years|OS truncated at 2 years was defined as the time from the date of randomization to the date of death from any cause, with deaths occurring beyond 2 years after the participant's randomization date censored at 2 years.|At 24 months|Data for this outcome measure were not collected and are therefore not reported. The study was terminated before the time point for data collection of this outcome measure.||||||
1327299|NCT02144012|Secondary|One-Year Survival Rate|One-year survival rate as determined by Kaplan-Meier estimates.|At 12 months|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.|||percentage of participants||95% Confidence Interval|Median
1327300|NCT02144012|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.|||months||95% Confidence Interval|Median
1327301|NCT02144012|Primary|Safety: Percentage of Participants With Significant Decline in Left Ventricular Ejection Fraction (LVEF)|Significant decline in LVEF was defined as LVEF below 50% and decrease from baseline of 15% points or more. Echocardiogram or multiple-gated acquisition (MUGA) scan was used to assess LVEF.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
1327302|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events Leading to Dose Reduction||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
1327303|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events Leading to Treatment Interruption||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
1327304|NCT02144012|Primary|Percentage of Participants With Adverse Events Leading to Treatment Discontinuation||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
1327305|NCT02144012|Primary|Safety: Percentage of Participants With Grade 3 and 4 AEs|Grade 3 and 4 AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Grade 3 was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living, including bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 was defined as life-threatening consequences; urgent intervention indicated.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
1327306|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
1327307|NCT02144012|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.|At time of clinical data cut-off (up to 20 months)|The intent-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.|||months||95% Confidence Interval|Median
1327308|NCT02143947|Secondary|Maximum First Ray Complex Plantarflexion During Stance|The first ray complex plantarflexion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum first ray complex plantarflexion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||Degrees||Standard Deviation|Mean
1327309|NCT02143947|Secondary|Maximum Forefoot Inversion During Stance|The forefoot inversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum forefoot inversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||Degrees||Standard Deviation|Mean
1327310|NCT02143947|Secondary|Maximum Electromyographic Activity of Lower Leg Muscles|The maximum electromyographic activity of the lower leg muscles is with respect to the barefoot condition. The electromyographic activity of the lower extremity muscles were recorded during the stance phase of walking while barefoot and while wearing their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization). All electromyographic measurements were taken at the 5 week time point. The peak electromyographic activity during the stance phase of barefoot walking was determined. The electromyographic activity during the orthotic condition was amplitude normalized to the barefoot condition by dividing the electromyographic activity of the orthotic condition by the peak barefoot electromyographic activity and multiplying by 100. The stance phase of walking was then divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the peak amplitude normalized electromyographic activity of each subphase det|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||percentage of maximum electromyo actvity||Standard Deviation|Mean
1327311|NCT02143947|Primary|Maximum Rearfoot Eversion Motion During Stance|The rearfoot eversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum rearfoot eversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||Degrees||Standard Deviation|Mean
1327312|NCT02143583|Secondary|Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season|"The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms).~For each question the answer is quoted from 0: no troubled to 6: extremely troubled; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case"|between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : patients having received at least 4 injections of AllerT or placebo in AN004T|||units on a scale||Standard Deviation|Mean
1327313|NCT02143583|Primary|Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season|"The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3).~The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows:~0 = no medication~= subject took topical antihistamine~= subject took oral antihistamine~= subject took oral corticosteroids"|from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : participants having received at least 4 injections of AllerT or placebo in AN004T|||units on a scale||Standard Deviation|Mean
1327574|NCT02139137|Secondary|Change in Depression: Beck Depression Inventory|Scale Range: 0-63; higher scores indicate greater symptom severity|Baseline, Week 4||||units on a scale||Standard Deviation|Mean
1327314|NCT02143141|Secondary|Nausea/Vomiting|The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting.|24 hours||||units on a scale||Standard Deviation|Mean
1327315|NCT02143141|Secondary|Itching|The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching.|24 hours||||units on a scale||Standard Deviation|Mean
1327316|NCT02143141|Primary|Pain|Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.|24 hours||||units on a scale||Standard Deviation|Mean
1327317|NCT02143102|Primary|Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.|Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)|Assessed on tissue samples collected within 30 days of non-invasive imaging||||mm2||95% Confidence Interval|Mean
1327318|NCT02143102|Primary|Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.|Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)|Assessed on tissue samples collected within 30 days of non-invasive imaging||||mm2||95% Confidence Interval|Mean
1327319|NCT02142738|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The ORR through the data cutoff date of 09 May 2016 is presented for each treatment group.|Through data cutoff data of 09 May 2016 (Up to approximately 1.6 years)|The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1327320|NCT02142738|Secondary|Overall Survival (OS) Rate at Month 6|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. In those instances where participants were confirmed to be alive on the visit cut-off date of 09 May 2016, survival was censored as of 09 May 2016. The OS rate at Month 6 was calculated.|Month 6|The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1327321|NCT02142738|Primary|Progression Free Survival (PFS) Rate at Month 6|PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists’ (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The PFS rate at Month 6 was calculated.|Month 6|The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1327322|NCT02142712|Other Pre-specified|CT or MRI of Head Without Contrast|MRI of head or CT head done as part of your follow up care at 3 months. This will give us the information about the effect of dextromethorphan effect on the final brain damage from stroke.|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.||||||
1327323|NCT02142712|Primary|Barthel Index|"It is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. It yields a score of 0-20.~The ten variables addressed in the Barthel scale are:~presence or absence of fecal incontinence~presence or absence of urinary incontinence~help needed with grooming~help needed with toilet use~help needed with feeding~help needed with transfers (e.g. from chair to bed)~help needed with walking~help needed with dressing~help needed with climbing stairs~help needed with bathing"|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.||||||
1327324|NCT02142712|Primary|Glasgow Coma Scale (GCS)|Glasgow Coma Scale (GCS) is assessed by physical neurological examination of the subject by a qualified neurologist. GSC is a common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. The initial score correlates with the severity of brain injury and prognosis. It estimates Coma severity based on Eye (4), Verbal (5), and Motor (6) criteria with the following total score of between 3 (indicating deep unconsciousness) and 15 (indicating no issues).|Baseline|Data was collected only for the baseline visit, since the participants did not come back for follow-ups.|||Glasgow Coma Scale|||Number
1327325|NCT02142712|Primary|National Institutes of Health Stroke Severity (NIHSS) Scale|NIHSS is a tool used by healthcare providers to objectively quantify the degree of impairment caused by a stroke. It is composed of 11 items. Each item scores a specific ability between a score of 0-4. Usually, for each item, a score of 0 indicates normal function in that specific ability, while a higher score indicates some level of impairment. The individual scores from each item are added together to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|Baseline|NIHSS data was only collected for the baseline visit, since the participants did not come back for follow-ups.|||NIHSS scale|||Number
1327627|NCT02138097|Secondary|Proportion of Days Covered for MarketScan Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in MarketScan cohort|||days covered||Standard Deviation|Mean
1327326|NCT02142712|Primary|Modified Rankin Score|"The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke.It is one of the most widely used clinical outcome measure for stroke clinical trials. The score is given according to following scale.~0- No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|8 days and 3 months from the baseline|The data was not collected since the participants did not come back for follow-ups.||||||
1327327|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.|Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.|||ratio||Standard Deviation|Geometric Mean
1327328|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||ratio||Standard Deviation|Geometric Mean
1327329|NCT02142504|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.|Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.|||titer||Standard Deviation|Geometric Mean
1327330|NCT02142504|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||titer||Standard Deviation|Geometric Mean
1327331|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum GII.4 VLP Antibody Titers (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-Like particle (VLP) as measured by HBGA binding assay.|Baseline and Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data for this outcome measure|||percentage of participants||95% Confidence Interval|Number
1327332|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum GI.1 VLP Antibody Titers (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by HBGA binding assay.|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1327333|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.|Baseline and Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1327334|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||ratio||Standard Deviation|Geometric Mean
1327335|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||ratio||Standard Deviation|Geometric Mean
1327336|NCT02142504|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||titer||Standard Deviation|Geometric Mean
1327337|NCT02142504|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||titer||Standard Deviation|Geometric Mean
1327338|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum Anti-norovirus GII.4 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particles (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1327628|NCT02138097|Secondary|Proportion of Days Covered for United Healthcare Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in United Healthcare cohort|||days covered||Standard Deviation|Mean
1327339|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum Anti-norovirus GI.1 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1327340|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1327341|NCT02142504|Secondary|Percentage of Participants With Unsolicited Adverse Events (AEs) After the Second Injection|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Days 365 through 393|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
1327342|NCT02142504|Secondary|Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the Second Injection|Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
1327343|NCT02142504|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the vaccination on Day 365.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
1327344|NCT02142504|Secondary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the vaccination on Day 365.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
1327345|NCT02142504|Primary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE occurred if the participant experienced an AE that required early termination because continued participation imposed an unacceptable risk to the participant's health or the participant was unwilling to continue because of the AE.|Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
1327346|NCT02142504|Primary|Percentage of Participants With Adverse Events of Special Interest (AESI) After the Second Injection|AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.|From second injection (Day 365) to 6 months after second injection (Up to Day 545)|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
1327347|NCT02142504|Primary|Percentage of Participants With Adverse Events of Special Interest (AESI) After the First Injection|AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.|From first injection (Day 1) to second injection pre-dose (Up to Day 365)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
1327348|NCT02142504|Primary|Percentage of Participants With Serious Adverse Events (SAEs) After the Second Injection|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|From second injection (Day 365) to 6 months after second injection (Up to Day 545)|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
1327349|NCT02142504|Primary|Percentage of Participants With Serious Adverse Events (SAEs) After the First Injection|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|From first injection (Day 1) to second injection pre-dose (Up to Day 365)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
1327350|NCT02142504|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs) After the First Injection|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Days 1 through 28|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
1327377|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at End of Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327351|NCT02142504|Primary|Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the First Injection|Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each injection. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
1327352|NCT02142504|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the primary injection.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
1327353|NCT02142504|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
1327354|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327355|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||degrees|Participants|Standard Deviation|Mean
1327356|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||degrees|Participants|Standard Deviation|Mean
1327357|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327358|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327359|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327360|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327361|NCT02142361|Primary|Clinicians Assessment Corneal Coverage-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327362|NCT02142361|Primary|Clinician's Assessment Corneal Coverage-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327363|NCT02142361|Primary|Clinician's Assessment Lens Centration- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327364|NCT02142361|Primary|Clinician's Assessment Lens Centration-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327365|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327366|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327367|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327368|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327369|NCT02142361|Primary|Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||LogMAR||Standard Deviation|Mean
1327370|NCT02142361|Primary|Clinician's Objective Assessment Monocular High Contrast Distance Visual|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||LogMAR||Standard Deviation|Mean
1327371|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Overall|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327372|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Lens Fit|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327373|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Vision|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327374|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Handling|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm.~Sum of percentage for the Study Lens Arm=101 as, Category title-  Somewhat dissatisfied- 1.7 was rounded to 2."|||percentage of eyes|Participants||Number
1327375|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
1327376|NCT02142361|Primary|Participant's Subjective Rating for Lens Pair Preference|Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.|1 week|"All 60 paticipants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm. Vision category data for one participant was not collected."|||Percentage of eyes|Participants||Number
1327378|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327379|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327380|NCT02142361|Primary|Participant's Subjective Rating for Night Vision Quality|Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327381|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality End of the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327382|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327383|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327384|NCT02142361|Primary|Participant's Subjective Rating for Overall Vision Satisfaction|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327385|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Fit Stability|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327386|NCT02142361|Primary|Participant's Subjective Rating for Lens Handling - Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327387|NCT02142361|Primary|Participant's Subjective Rating for Overall Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327388|NCT02142361|Primary|Participant's Subjective Rating for Dryness Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327389|NCT02142361|Primary|Participant's Subjective Rating for Dryness During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327390|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327391|NCT02142361|Primary|Participant's Subjective Rating for Lens Comfort Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327392|NCT02142361|Primary|Participant's Subjective Rating for Lens Initial Comfort|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
1327393|NCT02142283|Secondary|Neurological Deterioration From Baseline NIHSS Score|"Neurological deterioration from baseline NIHSS score through Day 5-7/discharge (whichever is earlier) post randomization. Neurological deterioration is defined as ≥ 4 point increase in the NIHSS score from the baseline score.~The calculated difference in NIHSS scores was assessed at baseline and Day 5-7/discharge (two time points).~The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0."|5-7 days|ITT|||Participants|||Count of Participants
1327394|NCT02142283|Secondary|Revascularization Rates|"Revascularization rates at 24 hours from randomization are based on the assessment of vessel patency utilizing CTA/MRA and processed by the CT-MR core laboratory. Revascularization at 24 hours was defined as the presence of partial or complete recanalization.~CTA/MRA images utilized ionizing radiation exposure."|24 hours|ITT|||Participants|||Count of Participants
1327395|NCT02142283|Secondary|All Cause Mortality||90 days|ITT|||Participants|||Count of Participants
1327396|NCT02142283|Secondary|Early Response|"The proportion of subjects with early response at Day 5-7/Discharge (whichever is earlier), defined as a National Institutes of Health Stroke Scale (NIHSS) drop of ≥10 from baseline or NIHSS score 0 or 1.~The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0."|5-7 Days||||Participants|||Count of Participants
1327397|NCT02142283|Secondary|Good Functional Outcome|"Proportion of participants with functional independence~mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.~Functional Independence:~0 - no symptoms at all~- no significant disability despite symptoms; able to carry out all usual duties and activities~- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance"|90 days|ITT|||Participants|||Count of Participants
1327398|NCT02142283|Primary|Stroke-related Mortality, Primary Safety Outcome||90 days|ITT|||Participants|||Count of Participants
1327399|NCT02142283|Primary|Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome|"Number of participants with functional independence~mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.~Functional Independence:~0 - no symptoms at all~- no significant disability despite symptoms; able to carry out all usual duties and activities~- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance"|90 days|ITT|||Participants|||Count of Participants
1327400|NCT02142283|Primary|Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome|"mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.~Functional Independence:~0 - no symptoms at all~- no significant disability despite symptoms; able to carry out all usual duties and activities~- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~- moderate disability; requiring some help, but able to walk without assistance~- moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~- severe disability; bedridden, incontinent and requiring constant nursing care and attention~- dead"|90 days|ITT|||score on a scale||Standard Deviation|Mean
1327401|NCT02142153|Other Pre-specified|Pharmacokinetics|Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples).|Single dose|||||||
1327402|NCT02142153|Secondary|Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities|Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit|Single dose||||participants|||Number
1327403|NCT02142153|Primary|Number of Subjects With Adverse Events|Adverse events will be collected from the time of screening until the final study visit|Single dose|Full analytical set|||participants|||Number
1327404|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
1327405|NCT02141997|Secondary|Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score from 2.8 to ≤ 10 at Week 12. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
1327406|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
1327407|NCT02141997|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. LDA is defined as a DAS28 (hsCRP) score from 2.6 to < 3.2 at Week 12. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
1327408|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12|Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
1327409|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12|Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
1327410|NCT02141997|Secondary|Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. A negative change from baseline represents improvement. n=the number of participants with evaluable data at each time point. LOCF was used (only post-baseline values were carried forward).|Baseline, Weeks 2, 4, 6, 8, and 12|Subjects in the FAS with a baseline value and at least 1 post-baseline value|||units on a scale||95% Confidence Interval|Least Squares Mean
1327411|NCT02141997|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire – Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Full analysis set (FAS) defined as all randomized participants with at least 1 dose of study drug.|||percentage of participants|||Number
1327412|NCT02141984|Secondary|Parent’s Global Assessment for Effectiveness|Parent’s global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.|||Participants|||Count of Participants
1327413|NCT02141984|Secondary|Physician's Global Assessment of the Disease|The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.|||participants|||Number
1327414|NCT02141984|Secondary|Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment|Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity.|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.|||active joint||Standard Deviation|Mean
1327415|NCT02141984|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.|Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)|Safety analysis set: All participants who received at least one administration of Humira during the study (after informed consent or first administration of Humira) and for 70 days following the last scheduled administration of Humira.|||participants|||Number
1327416|NCT02141867|Secondary|Duration of Critical Care Stay||Upto 30 days||||Days||Inter-Quartile Range|Median
1327417|NCT02141867|Secondary|Admission to Critical Care After Surgery||Upto 30 days||||participants|||Number
1327418|NCT02141867|Secondary|Duration of Hospital Stay||Upto 30 days||||Days||Inter-Quartile Range|Median
1327419|NCT02141867|Primary|Mortality|In hospital mortality|Upto 30 days||||participants|||Number
1327420|NCT02141854|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12 of the Treatment Period|Safety population|||Participants|||Count of Participants
1327440|NCT02141620|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327534|NCT02140164|Secondary|Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline|Visual Acuity was measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|Baseline and 12 Months||||eyes|eyes||Number
1327421|NCT02141854|Secondary|Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1|"The baseline forced expiratory volume in 1 second (FEV1) was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, the baseline trough FEV1 was treated as missing.~Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.~Values of NA indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%."|Day 1 of the Treatment Period (predose and postdose)|Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.|||hours||95% Confidence Interval|Median
1327422|NCT02141854|Secondary|Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old|"The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient’s quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.~Positive change from baseline scores indicate improved quality of life."|Day 1 (predose, baseline), end of trial (up to week 12)|Full analysis set of participants who contributed at least once to analysis and were >= 18 years old|||units on a scale||Standard Error|Least Squares Mean
1327423|NCT02141854|Secondary|Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12|The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.|up to Week 12 of the Treatment Period|Full analysis set|||probability||95% Confidence Interval|Number
1327424|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period|"Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week.~The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures."|Days -6 to Day 1 (predose, baseline), up to week 12|Full analysis set|||puffs||Standard Error|Least Squares Mean
1327425|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary.~Daytime Symptom Score:~0=No symptoms~1=Symptoms for 1 short period~2=Symptoms for 2+ short periods~3=Symptoms for most of the day - did not affect normal daily activities~4=Symptoms for most of the day - did affect normal daily activities~5=Symptoms so severe that I could not go to work or perform normal daily activities~Nighttime Symptom Score (determined in the AM):~0=No symptoms~1=Symptoms causing me to wake once (or wake early)~2=Symptoms causing me to wake twice or more (including waking early)~3=Symptoms causing me to be awake for most of the night~4=Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM)."|Days -6 to Day 1 (predose, baseline), to Week 12|Full analysis set|||units on a scale||Standard Error|Least Squares Mean
1327426|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment|"Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary.~The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week."|Days -6 to Day 1 (predose, baseline), Day 1 (postdose) daily until Week 12|Full analysis set|||liters/minute||Standard Error|Least Squares Mean
1327427|NCT02141854|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Trough FEV1 is a morning spirometry taken predose and pre-rescue bronchodilator. The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1).|Day 1 (predose, baseline), Week 12|If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.|||liters||Standard Error|Least Squares Mean
1327441|NCT02141620|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327468|NCT02141516|Primary|Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
1327428|NCT02141854|Primary|Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12|A subset of patients performed postdose serial spirometry. Data from these assessments were used to analyze the primary endpoint of baseline-adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value.|Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours|A subset of patients who performed postdose serial spirometry at the baseline visit and week 12.|||liters||Standard Error|Least Squares Mean
1327429|NCT02141633|Secondary|Echocardiogram|to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers|MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers||||ΔMPAP (mmHg)||Standard Error|Mean
1327430|NCT02141633|Primary|Airway Blood Flow|compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers|before and 15 minutes after albuterol inhalation||||ΔQaw (ul/min/ml)||Standard Error|Mean
1327431|NCT02141620|Secondary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||degrees Fahrenheit||Standard Error|Mean
1327432|NCT02141620|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||beats per minute||Standard Error|Mean
1327433|NCT02141620|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
1327434|NCT02141620|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
1327435|NCT02141620|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327436|NCT02141620|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327437|NCT02141620|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327438|NCT02141620|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327439|NCT02141620|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327521|NCT02140567|Primary|Specificity of the Syncope Prediction Algorithm|Number of tilt-negative participants corrected identified as negative by the syncope prediction algorithm|Tilt Test with average duration of 1 hour||||Participants|||Count of Participants
1327442|NCT02141620|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327443|NCT02141620|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327444|NCT02141620|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327445|NCT02141620|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327446|NCT02141620|Secondary|"Peak Ratings of Nauseous on the Visual Analog Scale"|"Subjects rated their feelings of Nauseous on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327447|NCT02141620|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327448|NCT02141620|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327449|NCT02141620|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327450|NCT02141620|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327451|NCT02141620|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327452|NCT02141620|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327467|NCT02141516|Primary|Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1327453|NCT02141620|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327454|NCT02141620|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327455|NCT02141620|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327456|NCT02141620|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1327457|NCT02141620|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.||||Number of Cocaine Choices||Standard Deviation|Mean
1327458|NCT02141581|Other Pre-specified|Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination||Baseline to Day 7|||||||
1327459|NCT02141581|Secondary|Number of Participants With Related Adverse Events|Number of participants with Related Adverse Events with a 0% Frequency Threshold|Baseline to Day 28||||Participants|||Count of Participants
1327460|NCT02141581|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Baseline to Day 28||||Participants|||Count of Participants
1327461|NCT02141516|Primary|Number Of Subjects With Unsolicited Adverse Events (AEs).|Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).|At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)|Analysis was done on the Unsolicited Safety Set (all subjects in the exposed set with postvaccination unsolicited AE records).|||participants|||Number
1327462|NCT02141516|Secondary|Number of Subjects Reporting Solicited Local and Systemic AEs.|Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.|From Day 1 until Day 7 after any vaccination.|Analysis was done on Solicited Safety Set (all subjects in the exposed set with any solicited AE data).|||participants|||Number
1327463|NCT02141516|Primary|Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Percentage of Subjects||95% Confidence Interval|Number
1327464|NCT02141516|Primary|ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
1327465|NCT02141516|Primary|Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||IU/mL||95% Confidence Interval|Geometric Mean
1327466|NCT02141516|Primary|Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Percentage of Subjects||95% Confidence Interval|Number
1327522|NCT02140567|Primary|Sensitivity of the Syncope Prediction Algorithm|Number of tilt-positive participants corrected predicted by the syncope prediction algorithm|Tilt Test with average duration of 1 hour||||Participants|||Count of Participants
1327523|NCT02140372|Secondary|Platelet Adhesion: 2 Hours||2 hours||||percentage of adhered platelets||Inter-Quartile Range|Median
1327469|NCT02141516|Primary|Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Percentage of Subjects||95% Confidence Interval|Number
1327470|NCT02141516|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine)|Analysis was done on Full Analysis Set (all subjects in the enrolled set who: received a study vaccination and provided an evaluable serum sample at 1 month after the second dose of rMenB+OMV NZ, with assay result available for at least one of the serogroup B indicator strains or M10713 strain or ELISA).|||Percentage of Subjects||95% Confidence Interval|Number
1327471|NCT02141360|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided|Baseline to 3 months|Study was terminated and no subject outcome data were collected||||||
1327472|NCT02141217|Secondary|Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1327473|NCT02141217|Secondary|Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1327474|NCT02141217|Secondary|Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5|CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but ‘no change’ or ‘worsening from BL’ in other s/sx (like increased leucocyte count/tooth mobility), the inv’s opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with ‘no change’ or ‘worsening from BL’ in these other s/sx were considered as cl failures and termed ‘Without Considering Cl Jdg of Inv’, even though main s/sx are 'cured' or 'improved'. .|Day 5|ITT-E Population|||Participants|||Number
1327475|NCT02141217|Secondary|Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5|ITT-E Population. Only the participants with Day 5 assessments were considered for analysis.|||Participants|||Number
1327476|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-to-Treat (ITT) Population (randomized as per treatment allocation): all randomized participants who received at least one dose of study medication. If the post-Baseline assessment of clinical success response was missing then “Clinical Success” is considered as “No” i.e. the participant was treated as “Clinical Failure”.|||Percentage of participants|||Number
1327524|NCT02140372|Secondary|Platelet Adhesion: Baseline||Baseline||||percentage of adhered platelets||Inter-Quartile Range|Median
1327525|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine epinephrine|2 hours||||percentage of max platelet aggregation||Inter-Quartile Range|Median
1327477|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-To-Treat-Efficacy (ITT-E) Population: all participants in the ITT participants who had at least one post-Baseline assessment of clinical success response (clinical response based on assessment on odontogenic infection and VAS Score).|||Percentage of participants|||Number
1327478|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Per-Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (defined as all randomized participants who received at least one dose of study medication) who were without major protocol violations and had end of treatment clinical response assessment available.|||Percentage of participants|||Number
1327479|NCT02140957|Secondary|Current Nighttime Bottle Use|Current nighttime bottle use.|2 years||||participants|||Number
1327480|NCT02140957|Secondary|Current Bottle Use|Current daytime bottle use.|2 years||||participants|||Number
1327481|NCT02140957|Primary|Change in Iron Depletion|Iron depletion (serum ferritin < 10 μg/L).|Baseline, 2 years||||percentage of participants|||Number
1327482|NCT02140788|Secondary|Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items|The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization.|baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
1327483|NCT02140788|Secondary|Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
1327484|NCT02140788|Secondary|Changes in C-reactive Protein and Sedimentation Rates||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
1327485|NCT02140788|Secondary|Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
1327486|NCT02140788|Primary|Change in Weight||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
1327487|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at One Month After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128, against serogroups A, C, W, Y, at one month after the 2-dose vaccination series.|One month after the second vaccination (month 3)|Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||percentage of subjects||95% Confidence Interval|Number
1327488|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at One Month After the 2-dose Vaccination Series.|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at one month after the 2-dose vaccination series, is reported.|One month after the second vaccination (month 3)|Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||percentage of subjects||95% Confidence Interval|Number
1327489|NCT02140762|Secondary|HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at four months after the 2-dose vaccination series.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||95% Confidence Interval|Geometric Mean
1327490|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128, against serogroups A, C, W, Y at four months after the 2-dose vaccination series.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentages of subjects||95% Confidence Interval|Number
1327491|NCT02140762|Secondary|HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against serogroup B test strains, at four months after the 2-dose vaccination series.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||95% Confidence Interval|Geometric Mean
1327492|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at four months after the 2-dose vaccination series, is reported.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||percentage of subjects||95% Confidence Interval|Number
1327493|NCT02140762|Secondary|Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains at four months after the 2-dose vaccination series is reported.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
1327494|NCT02140762|Secondary|Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject|The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at four months after the 2-dose vaccination series is reported.|Baseline, four months after second vaccination (month 6)|Analysis was done on FAS effectiveness (month 6).|||Mean percentage of strains||Standard Deviation|Mean
1327495|NCT02140762|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.|"The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|Four months after the second vaccination (month 6)|Analysis was done on FAS effectiveness (month 6).|||Percentage of subjects||Standard Deviation|Mean
1327496|NCT02140762|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.|"The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|Four months after the second vaccination (month 6)|Analysis was done on FAS effectiveness (month 6): All subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at four months after the 2-dose series (Visit Month 6).|||Percentage of subjects||Standard Deviation|Mean
1327497|NCT02140762|Secondary|Number of Subjects Reporting Unsolicited AEs.|Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).|From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.|Analysis was done on the unsolicited safety set, ie, all subjects in the exposed set with any unsolicited adverse event data and/or indicators of unsolicited adverse events. Analysis for AEs leading to withdrawal was done on All Enrolled Set population.|||Subjects|||Number
1327498|NCT02140762|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.|From day 1 (6 hours) until day 7 after any vaccination|Analysis was done on Solicited Safety Set: all subjects in the All Exposed Set who have provided any solicited adverse event data and/or other indicators or reactogenicity|||subjects|||Number
1327499|NCT02140762|Secondary|hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.|One month after the second vaccination (month 3)|Analysis was done on FAS Immunogenicity (Month 3)|||Titers||95% Confidence Interval|Geometric Mean
1327500|NCT02140762|Secondary|hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.|One month after the second vaccination (month 3)|Analysis was done on FAS Immunogenicity (Month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||95% Confidence Interval|Geometric Mean
1327501|NCT02140762|Secondary|Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA >= 1:4 and enc-hSBA titer >= 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.|One month after the second vaccination (month 3)|Analysis was done on FAS Immunogenicity (Month 3): all subjects in the All Enrolled Set who received a study vaccination, provided evaluable serum samples respectively at 1 month post-second vaccination (Visit Month 3) whose immunogenicity assay result is available for at least one N. meningitidis serogroup B test strain or serogroups A, C, W or Y.|||Percentage of Subjects||95% Confidence Interval|Number
1327502|NCT02140762|Secondary|Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject|The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.|Baseline, one month after second vaccination (month 3)|Analysis was done on FAS effectiveness (month 3)|||Mean percentages of strains||Standard Deviation|Mean
1327503|NCT02140762|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination|"The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|One month after the second vaccination (month 3)|Analysis was done on FAS effectiveness ( month 3)|||Percentage of subjects||Standard Deviation|Mean
1327504|NCT02140762|Primary|Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.|"The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|One month after the second vaccination (month 3)|Analysis was done on Full Analysis Set (FAS) effectiveness (month 3): all subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at one month after the 2-dose series (Visit Month 3).|||Percentages of subjects||Standard Deviation|Mean
1327505|NCT02140645|Primary|Binary EMR Characteristic: Pancreatitis|"The missing EMR characteristic pancreatitis defined as participants with any note of prior pancreatitis.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic pancreatitis was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
1327506|NCT02140645|Primary|Binary EMR Characteristic: Retinopathy|"The missing EMR characteristic retinopathy defined as participants with any note of diabetic retinopathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic retinopathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
1327507|NCT02140645|Primary|Binary EMR Characteristic: Nephropathy|"The missing EMR characteristic nephropathy defined as participants with any note of diabetic nephropathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic nephropathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
1327508|NCT02140645|Primary|Binary EMR Characteristic: Neuropathy|"The missing EMR characteristic neuropathy defined as participants with any note of diabetic neuropathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic neuropathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
1327509|NCT02140645|Primary|Missing EMR Characteristic: Diastolic BP|"The missing EMR characteristic diastolic BP defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic diastolic BP was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||mmHg||Standard Deviation|Mean
1327510|NCT02140645|Primary|Missing EMR Characteristic: Systolic BP (Blood Pressure)|"The missing EMR characteristic systolic BP defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic systolic BP was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||mmHg||Standard Deviation|Mean
1327511|NCT02140645|Primary|Missing EMR Characteristic: Total Cholesterol|"The missing EMR characteristic total cholesterol defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic total cholesterol was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||mg/dl||Standard Deviation|Mean
1327512|NCT02140645|Primary|Missing EMR Characteristic: eGFR (Glomerular Filtration Rate)|"The missing EMR characteristic eGFR defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic eGFR was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||ml/min per 1.73 m^2||Standard Deviation|Mean
1327513|NCT02140645|Primary|Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin))|"The missing EMR characteristic HbA1c defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic HbA1c was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage||Standard Deviation|Mean
1327514|NCT02140645|Primary|Missing EMR Characteristic: BMI (Continuous)|"The missing EMR characteristic BMI is BMI value. Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics BMI as continuous outcomes.~The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Kg/m^2||Standard Deviation|Mean
1327515|NCT02140645|Primary|Missing EMR Characteristic: BMI (Body Mass Index)|"The missing EMR characteristic BMI defined as not obese, overweight, obese, severe obesity.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic BMI was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
1327516|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes (Continuous)|"The missing EMR characteristic duration of diabetes defined as starting year/starting age of diabetes.~Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics duration of diabetes as continuous outcomes.~The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Months||Standard Deviation|Mean
1327517|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes|"The missing EMR characteristic duration of diabetes defined as >7, 5-6, 3-5, 1-3, <1 (in years) in duration.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic duration of diabetes was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
1327518|NCT02140645|Primary|Missing EMR (Electronic Medical Record) Characteristic: Smoking|"The missing EMR characteristic smoking defined as current, unknown, versus past/never smoker.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic smoking was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
1327519|NCT02140593|Secondary|The Surgical Rating Score During Fascial Closure|After last suture of fascial closure surgical conditions are rated on a 5 point scale|Immediatly after fascial closure||||units on a scale||Full Range|Mean
1327520|NCT02140593|Primary|Surgical Rating Score|The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)|After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes||||units on a scale||Full Range|Median
1327535|NCT02140164|Secondary|Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||||dB||Standard Deviation|Mean
1327536|NCT02140164|Secondary|Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months|Two participants had to switch to HVF 10-2; therefore they were not included in the analysis.|||dB||Standard Deviation|Mean
1327537|NCT02140164|Secondary|Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||||dB||Standard Deviation|Mean
1327538|NCT02140164|Secondary|Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months||||decibels (dB)||Standard Deviation|Mean
1327539|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported.|Pre-treatment and 12 Months|Participants had non-recordable ERGs; therefore, changes could not be measured.||||||
1327540|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported.|Pre-Treatment and 6 Months|Participants had non-recordable ERGs; therefore, changes could not be measured.||||||
1327541|NCT02140164|Secondary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to the Average of the Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||||microns||Standard Deviation|Mean
1327542|NCT02140164|Primary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to the Average of the Pre-treatment Values.|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months|Participants receiving investigational product (IP) at the Month 6 visit were included in the primary efficacy analysis.|||microns||Standard Deviation|Mean
1327543|NCT02140060|Primary|Mean IOP at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.|Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM|"This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, n is the number of subjects with non-missing values at the specific time point for each arm, respectively."|||mmHg||Standard Error|Mean
1327544|NCT02139982|Primary|Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|The cross-sectional area(CSA, cm2) of Radial/ulnar Artery was assessed with B-mode imaging. Probe was kept perpendicular to the long axis of the artery to obtain the largest oval arterial section. The image at end diastole was chosen and measured with the cine loop.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)||||cm^2||Standard Deviation|Mean
1327545|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)|Skin temperature was measured at the thenar. change= 30min after brachial plexus block minus baseline|Baseline,30 min after brachial plexus block||||℃||Standard Deviation|Mean
1327546|NCT02139982|Secondary|Success of Brachial Plexus Block ( Phase 2)|Success of Brachial Plexus Block(BPB) was defined as the absence of sensation to in all innervation areas of above four nerves (musculocutaneous, ulnar, radial, and median nerves) 30min. after the BPB and no pain during the surgery.|30 min after brachial plexus block||||participants|||Number
1327547|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)|Skin temperature(Ts) was measured at four different points within the cutaneous innervation areas of the musculocutaneous(lateral skin of forearm), ulnar(hypothenar region), radial (thumb-index web) and median(thenar) Specific points were located with skin marker to provide consistency of measurement.|baseline, 30 min after specific nerve block, 30 min after brachial plexus block||||℃||Standard Deviation|Mean
1327548|NCT02139982|Primary|Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)|"These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX), resistance index (RI), and pulsatility index (PI),The cross-sectional area of the artery imaging.Blood flow (BF) = TAMAX× CSA×60s.~Relative ratio of hemodymanic parameter=30 min after brachial plexus block divide by baseline"|baseline, 30 min after brachial plexus block||||ratio||Inter-Quartile Range|Median
1327549|NCT02139982|Primary|Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX),and was measured by Pulsed-wave Doppler(PWD) ultrasound.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)||||cm/s||Standard Deviation|Mean
1327550|NCT02139943|Primary|Percentage of Participants With Adverse Events||Up to 22 Weeks|Safety Analysis Set included all randomized participants who took at least 1 dose of double-blind study drug.|||percentage of participants|||Number
1327551|NCT02139943|Primary|Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight|Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.|Week 18|Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug. 'N (Number of Participants Analyzed)’ signifies participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1327552|NCT02139878|Secondary|Glucose|Plasma blood glucose concentrations|Up to 4 weeks||||mmol/L||Standard Error|Mean
1327553|NCT02139878|Primary|Blood Pressure|Systolic blood pressure|Up to 4 weeks||||mm Hg||Standard Error|Mean
1327554|NCT02139644|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12 of the Treatment Period|Safety population|||Participants|||Count of Participants
1327555|NCT02139644|Secondary|Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1|"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Baseline FEV1 was the average of 2 FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, baseline was treated as missing. Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.~Values of 9999 indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%."|Day 1 of the Treatment Period (predose and postdose)|Full analysis set: a subset of patients who performed postdose serial spirometry on Day 1|||hours||95% Confidence Interval|Median
1327556|NCT02139644|Secondary|Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old|"The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self-administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient’s quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score of 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.~Positive change from baseline scores indicate improved quality of life."|Day 1 (predose, baseline), end of trial (up to week 12)|FAS patients who contributed at least once to analysis and were >= 18 years old|||units on a scale||Standard Error|Least Squares Mean
1327557|NCT02139644|Secondary|Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12|The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.|up to Week 12 of the Treatment Period|FAS|||probability||95% Confidence Interval|Number
1327558|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period|Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week. The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures.|Days -6 to Day 1 (predose, baseline), up to week 12|FAS of patients who contributed at least once to the analysis|||puffs||Standard Error|Least Squares Mean
1327559|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary (range 0-9).~Daytime Symptom Score:~0=No symptoms~Symptoms for 1 short period~Symptoms for 2+ short periods~Symptoms for most of the day - did not affect normal daily activities~Symptoms for most of the day - did affect normal daily activities~Symptoms so severe that I could not go to work or perform normal daily activities~Nighttime Symptom Score (determined in the AM):~0=No symptoms~Symptoms causing me to wake once (or wake early)~Symptoms causing me to wake twice or more (including waking early)~Symptoms causing me to be awake for most of the night~Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM)."|Days -6 to Day 1 (predose, baseline) to Week 12|Full analysis set of patients who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
1327571|NCT02139176|Primary|Number of Women Who Came With Their Partners and Received Couple Counseling and Testing|Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.|three months||||Female participants receiving CHTC|||Number
1327560|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment|Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary. The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week.|Days -6 to Day 1 (predose), Day 1 (postdose) daily until Week 12|Full analysis set of patients who contributed at least once to the analysis.|||liters/minute||Standard Error|Least Squares Mean
1327561|NCT02139644|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|"Trough FEV1 was a morning spirometry taken predose and pre-rescue bronchodilator. If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.~The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1)."|Day 1 (predose, baseline), Week 12|Full analysis set|||liters||Standard Error|Least Squares Mean
1327562|NCT02139644|Primary|Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12|"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Data from these assessments were used to analyze the primary endpoint of baseline adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement.~The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value."|Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours|Full analysis set: a subset of patients who performed postdose serial spirometry at the baseline visit and week 12|||liters||Standard Error|Least Squares Mean
1327563|NCT02139358|Secondary|Overall Survival (OS)|Median overall survival (in months) for all participants evaluable for response. The length of time from the start of treatment that participants are still alive.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
1327564|NCT02139358|Secondary|Phase II: Progression Free Survival (PFS)|Median progression free survival (in months) for all participants evaluable for response. The time-to-event data will be summarized using Kaplan-Meir curve method for all patients who are evaluable for the ORR endpoint. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions.|Up to 12 months|All participants|||months||95% Confidence Interval|Median
1327565|NCT02139358|Primary|Phase II: Objective Response Rate (ORR)|Objective Response Rate: Response according to Response Evaluation in Solid Tumors (RECIST) 1.1 for the combination of gemcitabine+trastuzumab+pertuzumab at the recommended phase II dose. Complete Response (CR): Disappearance of all evidence of tumor for at least two cycles of therapy. Tumor markers must be normal. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking a reference the baseline sum longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions.|Up to 36 Months|All participants who have undergone 2 treatment cycles followed by a response scan and have documented best response data available.|||Participants|||Count of Participants
1327566|NCT02139358|Primary|Phase I: Recommended Phase II Dose (RP2D)|The RP2D dose in mg/m^2 of gemcitabine along with standard doses of pertuzumab (840 mg loading/420 mg maintenance) and Herceptin (8 mg/kg loading, 6 mg/kg maintenance). Safety data to be described using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 terminology. Any participant who receives any dose of the study treatment will be evaluated for the safety/toxicity endpoints in the trial.|6 Months|All participants enrolled during Phase 1|||dose in mg/m^2|||Number
1327567|NCT02139228|Secondary|Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as the percentages of subjects with Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS) (i.e. All subjects in the All Enrolled Set with no reportable protocol deviations).|||Percentage of subjects||95% Confidence Interval|Number
1327568|NCT02139228|Primary|Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS)-All subjects in the All Enrolled Set with no reportable protocol deviations.|||Concentration in μg/mL||95% Confidence Interval|Geometric Mean
1327569|NCT02139176|Secondary|Male Linkage to Care|It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center.|one month from male presentation to the clinic|These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population.|||partners linked to care|||Number
1327570|NCT02139176|Secondary|Female First Option B+ Follow-up Visit|It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared.|three months||||participants|||Number
1327575|NCT02139137|Secondary|Clinician Administered PTSD Scale Total Score - Responder Status|Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score|Week 4|Number of participants analyzed is based on the number of participants who completed the post-treatment CAPS interview.|||Participants|||Count of Participants
1327576|NCT02139137|Primary|Change in Clinician Administered PTSD Scale; Re-experiencing|"Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below.~Scale range: 0-40, higher values indicate greater symptom severity"|Baseline, Week 4||||units on a scale||Standard Error|Mean
1327577|NCT02139046|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
1327578|NCT02139046|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1327579|NCT02139046|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
1327580|NCT02139007|Secondary|Osteonecrosis of the Jaw|Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .|Baseline to 6 months following enrollment||||Participants|||Count of Participants
1327581|NCT02139007|Secondary|Atypical Femoral Fracture|Patient reported fracture rate at 6 months after enrollment via follow-up survey|Baseline to 6 months following enrollment||||Participants|||Count of Participants
1327582|NCT02139007|Secondary|Clinical Fracture Rate|Patient reported fracture rate at 6 months following enrollment via survey.|Baseline to 6 months following enrollment||||Participants|||Count of Participants
1327583|NCT02139007|Primary|All Study Sites-Length of Time to 1st Participant Enrolled|Mean time from study initiation to 1st participant enrolled.|Length of time t for sites to recruit/enroll 1st participant|For sites enrolling at least one patient, the average (SD) time from contract execution to the first patient recruited.|||Months|Sites|Standard Deviation|Mean
1327584|NCT02139007|Primary|All Study Sites--Length of Time to Site IRB Approval|Mean time to gain site IRB approval|Length of time to site IRB approval||||Days|Sites|Standard Deviation|Mean
1327585|NCT02139007|Primary|All Study Sites--Length of Contracting Procedures|Mean time Between Clinical Site Recruitment and Contract Execution|Length of time Between Clinical Site Recruitment and Contract Execution|Nine sites from six states (AL, CO, NM, CT, CA, and PA) participated in this pilot study.|||Months|Sites|Standard Deviation|Mean
1327586|NCT02138838|Secondary|Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.|||mg/dL||Standard Error|Least Squares Mean
1327587|NCT02138838|Secondary|Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.|||mg/dL||Standard Error|Least Squares Mean
1327588|NCT02138838|Secondary|Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.|||percent change||Standard Error|Least Squares Mean
1327589|NCT02138838|Secondary|Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20||Efficacy assessment period, weeks 17 to 20|This analysis was conducted using the full analysis set. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.|||percentage of participants|||Number
1327590|NCT02138838|Primary|Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period|"Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.~This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint."|Baseline and the efficacy assessment period (EAP), weeks 17 to 20|The full analysis set (all randomized participants) was used for this analysis. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.|||percentage of participants|||Number
1327591|NCT02138838|Primary|Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15|"Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.~This endpoint was the primary endpoint in the US only."|Baseline and weeks 11 to 15|The analysis was conducted using the full analysis set; participants who had no week 11 or 15 iPTH values were considered non-responders (non-responder imputation).|||percentage of participants|||Number
1327772|NCT02135900|Primary|Lowest Oxygen Saturation (L SO2)|Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Percentage of oxygen saturation||95% Confidence Interval|Mean
1327592|NCT02138825|Post-Hoc|Number of Serious Adverse Events During Safety Follow-up Phase|At the time of study termination, all participants entered safety follow-up phase regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.|From start of safety follow-up phase until end of study|Safety analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
1327593|NCT02138825|Post-Hoc|Number of Deaths Per Study Phase for Placebo Group|In the main study treatment phase participants received Placebo until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants were treated with Riociguat. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE.|From start of treatment to end of study|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
1327594|NCT02138825|Post-Hoc|Number of Deaths Per Study Phase for Riociguat Group|In the main study treatment phase participants received Riociguat until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants continued with Riociguat treatment. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE.|From start of treatment to end of study|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
1327595|NCT02138825|Secondary|Number of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); >15% decrease in the 6MWD test; worsening of WHO functional class.|From baseline to week 26|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
1327596|NCT02138825|Primary|Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26|The 6MWD test is designed to evaluate a patient’s exercise capacity while performing an everyday activity.|Baseline to 26 weeks|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Meter||Standard Deviation|Mean
1327597|NCT02138747|Secondary|Number of Participants With Adverse Events|Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug.|Baseline to EOT (Week 18) and follow up (Week 20)|Safety Analysis Set consisted of all participants who received at least 1 dose of double-blind study drug (SAF).|||Participants|||Number
1327598|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|"Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit.~Last observation carried forward imputation (LOCF) was utilized."|||Micturitions||Standard Error|Least Squares Mean
1327599|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|Full Analysis Set Incontinence (FAS I) consisted of all participants in the FAS who had at least 1 incontinence episode in the baseline 3-day micturition diary and at least 1 postbaseline diary during period 1.Last observation carried forward imputation (LOCF) was utilized.|||Incontinence Episodes||Standard Error|Least Squares Mean
1327600|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication|Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
1327601|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication|Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
1327602|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication|Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
1327603|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB|Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Unit on a Scale||Standard Error|Mean
1327604|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant’s Fulfillment of OAB Medication Expectations|The final item score for overall assessment of patient’s fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
1327605|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control|Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
1327606|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control|OAB control was scored from 0 to 100, with higher scores indicating better OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
1327607|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.|Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
1327608|NCT02138747|Secondary|Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.|"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (“strong preference for period 1,” “mild preference for period 1,” “no preference,” “mild preference for period 2,” “strong preference for period 2”). Participants who selected either a “mild preference” or “strong preference” were considered as having a preference for a specific study drug and participants who selected “no preference” were considered as having no preference for one study drug over the other study drug."|Week 18 (End of Period 2)|Full Analysis Set (FAS-PNP [Preference/No Preference]) consisted of all randomized participant who took at least 14 days of double-blind study drug in each treatment period and had filled out the patient preference form.|||Percentage of participants|||Number
1327609|NCT02138747|Primary|Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)|The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).|Week 8 (End of Period 1) and Week 18 (End of Period 2)|The Full Analysis Set (FAS) comprised of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Least Squares Mean
1327610|NCT02138578|Secondary|Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms|All patients will be followed to assess the development of treatment related pain, and resultant usage of analgesics (drug classification and dosage) for treatment related pain. Incidence and severity of pain will be recorded for all patients, using the Common Terminology Criteria for Adverse Events (CTCAE), as will any resultant use of analgesics, and these will be compared between the two arms and analyzed in the non-randomized SBRT cohort.|Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
1327611|NCT02138578|Secondary|Overall Survival Time||36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
1327612|NCT02138578|Secondary|Metastasis Free Survival Time||36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
1327613|NCT02138578|Secondary|Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms|Patient time away from work/home secondary to treatment will be captured via patient questionnaire as a number of days and will be summarized descriptively by treatment group. Any differences between treatment groups will be tested by a two-sample t-test or nonparametric Mann-Whitney test.|Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
1327832|NCT02135445|Secondary|Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
1327614|NCT02138578|Secondary|Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms|QOL scores will be summarized descriptively by treatment at each time point using the Convalescence and Recovery Evaluation (CARE) and SF-12 quality of life assessments . Any differences between treatment groups will be tested in the context of a general linear model with terms for treatment, time, treatment time and possibly other patient level covariates that might explain QOL.|Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
1327615|NCT02138578|Primary|Cumulative Incidence of Grade 2 and Greater Toxicities|The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used).|up to 30 days after the last study treatment|Although no patients reported toxicity, the trial had poor accrual and patients were unable to be followed per protocol.|||Participants|||Count of Participants
1327616|NCT02138578|Primary|Proportion of Patients With Local Control of Disease|On imaging, local control will be defined as when the treated lesion shows no enhancement.|12 months|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
1327617|NCT02138461|Primary|Tolerability of Medications as Measured by the COMTOL Validated Instrument|Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.|at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study||||percentage of patients|||Number
1327618|NCT02138227|Secondary|Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers|Requester staff self-report assessment utilizing a seven-point scale to rate his/her own comfort and satisfaction with the overall request process following each family contact. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The assessment was performed using a Likert scale ratin with a range of 1 to 7, with higher values representing better outcomes.|Baseline and continuously for 3 years post intervention||||units on a scale|Organ Donation Encounters|Standard Deviation|Mean
1327619|NCT02138227|Secondary|Change in Requesters' Aggregated Relational Communication Skills|Using a family interview, we will examine the family's experience with the donation process, specifically focusing on family self-report of comfort, satisfaction with the communication and decision-making process, content of the conversation, and measurement of the relational aspects of the communication. The instrument is based on a well-developed interview that was used in a seminal study of family experience and decision-making for organ donation in acute care hospital settings. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The aggregate scores of fourteen (14) 7-point scale items with an aggregate range of 14 to 98. Higher values represent a better outcome.|Baseline and continuously for 3 years post intervention||||units on a scale|Total organ donation approach encounters|Standard Deviation|Mean
1327620|NCT02138227|Primary|Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients|OPO requesters completed a brief, web-based survey after every family approach, regardless of whether the family ultimately consented to donation. Rates of baseline and post-intervention consent to donation were compared. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level.|Baseline and continuously for 3 years post intervention||||Percentage of successful requests|Total organ donation approach encounters||Number
1327621|NCT02138097|Secondary|Persistence at 12 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in MarketScan cohort|||Percentage of participants|||Number
1327622|NCT02138097|Secondary|Persistence at 6 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in MarketScan cohort|||Percentage of participants|||Number
1327623|NCT02138097|Secondary|Persistence at 3 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in MarketScan cohort|||Percentage of participants|||Number
1327624|NCT02138097|Secondary|Persistence at 12 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in United Healthcare cohort|||Percentage of participants|||Number
1327625|NCT02138097|Secondary|Persistence at 6 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in United Healthcare cohort|||Percentage of participants|||Number
1327626|NCT02138097|Secondary|Persistence at 3 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in United Healthcare cohort|||Percentage of participants|||Number
1327629|NCT02138097|Secondary|Treatment Discontinuation for Marketscan Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in Marketscan cohort|||participants/1000 participant years|||Number
1327630|NCT02138097|Secondary|Treatment Discontinuation for United Healthcare Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in United Healthcare cohort|||participants/1000 participant years|||Number
1327631|NCT02138097|Primary|Subsequent Insulin Initiation for MarketScan Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in MarketScan cohort|||participants/1000 participant years|||Number
1327632|NCT02138097|Primary|Subsequent Insulin Initiation for United Healthcare Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in United Healthcare cohort|||participants/1000 participant years|||Number
1327633|NCT02138097|Primary|Treatment Augmentation for MarketScan Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in MarketScan cohort|||participants/1000 participant years|||Number
1327634|NCT02138097|Primary|Treatment Augmentation for United Healthcare Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in United Healthcare cohort|||participants/1000 participant years|||Number
1327635|NCT02138097|Primary|Treatment Switching for MarketScan Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in MarketScan cohort|||participants/1000 participant years|||Number
1327636|NCT02138097|Primary|Treatment Switching for United Healthcare Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in United Healthcare cohort|||participants/1000 participant years|||Number
1327637|NCT02138097|Primary|Proportion of Initiators for MarketScan Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in MarketScan cohort|||Percentage of participants|||Number
1327638|NCT02138097|Primary|Proportion of Initiators for United Healthcare Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in the United Healthcare cohort|||Percentage of participants|||Number
1327639|NCT02138006|Secondary|Morbidity of Cardiovascular Complications|Morbidity of: coronary heart disease, stroke and renal failure|Up to 28 years||||participants|||Number
1327640|NCT02138006|Primary|Cardiovascular Mortality|All cause mortality and composite mortality from myocardial infarction, stroke and renal failure|Up to 28 years||||participants|||Number
1327641|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT|||participants|||Number
1327642|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT|||participants|||Number
1327643|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|4 Weeks after PDT #1|ITT|||participants|||Number
1327644|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|2 Weeks after PDT #1|ITT|||participants|||Number
1327645|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|ITT|||participants|||Number
1327833|NCT02135445|Secondary|Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
1327646|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT|||participants|||Number
1327647|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|ITT|||participants|||Number
1327648|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks after PDT #1|ITT|||participants|||Number
1327649|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|4 Weeks after PDT #1|ITT|||participants|||Number
1327650|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks after PDT #1|ITT|||participants|||Number
1327651|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|ITT|||participants|||Number
1327652|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT|||participants|||Number
1327653|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT|||participants|||Number
1327654|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT|||participants|||Number
1327655|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|4 Weeks after PDT #1|ITT|||participants|||Number
1327656|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT|||ITT|||Number
1327657|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 Hours after PDT #1|ITT|||participants|||Number
1327658|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT|||participants|||Number
1327659|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT|||participants|||Number
1327660|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT|||participants|||Number
1327661|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT|||participants|||Number
1327662|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT|||participants|||Number
1327663|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|4 Weeks after PDT #1|ITT|||participants|||Number
1327664|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 weeks after PDT #1|ITT|||participants|||Number
1327665|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|ITT|||participants|||Number
1327666|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1|ITT|||participants|||Number
1327667|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT|||participants|||Number
1327668|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT|||participants|||Number
1327669|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT|||participants|||Number
1327670|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|4 Weeks after PDT #1|ITT|||participants|||Number
1327671|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT|||participants|||Number
1327672|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|ITT|||participants|||Number
1327673|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1|ITT|||participants|||Number
1327674|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT|||participants|||Number
1327675|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT|||participants|||Number
1327834|NCT02135445|Secondary|Number of Participants With TEAEs Related to Physical Findings||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
1327676|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT|||participants|||Number
1327677|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT|||participants|||Number
1327678|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT|||participants|||Number
1327679|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT|||participants|||Number
1327680|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|ITT|||participants|||Number
1327681|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT|||participants|||Number
1327682|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT|||participants|||Number
1327683|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT|||participants|||Number
1327684|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT|||participants|||Number
1327685|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT|||participants|||Number
1327686|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT|||participants|||Number
1327687|NCT02137785|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|ITT|||participants|||Number
1327688|NCT02137785|Secondary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8|ITT|||participants|||Number
1327689|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 8|ITT using observed data only|||percentage of baseline lesions cleared||Standard Deviation|Mean
1327690|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 12|ITT using observed data only|||percentage of baseline lesions cleared||Standard Deviation|Mean
1327691|NCT02137785|Primary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|ITT|||participants|||Number
1327835|NCT02135445|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
1327692|NCT02137772|Other Pre-specified|Percentage of Participants Discontinued From Study Medication Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 14 post-transplant|All randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
1327693|NCT02137772|Other Pre-specified|Percentage of Participants With One or More Adverse Events up to Week 48 Post-transplant|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 48 post-transplant|All randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
1327694|NCT02137772|Secondary|Time to Initiation of Pre-emptive Therapy for CMV Viremia (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)|The need for anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The outcome was calculated from the day of transplantation to the start of anti-CMV pre-emptive therapy, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not initiate pre-emptive therapy.|Up to Week 24 post-transplant|All randomized participants who received at least one dose of study drug and had no detectable CMV viral DNA on the day treatment was initiated.|||Percentage of participants||95% Confidence Interval|Number
1327695|NCT02137772|Secondary|Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 24 Post-transplant|Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.|Up to Week 24 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 24-week visit window were considered treatment failure (i.e. NC=F approach was used).|||Percentage of participants|||Number
1327696|NCT02137772|Secondary|Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 14 Post-transplant|Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.|Up to Week 14 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 14-week visit window were considered treatment failure (i.e. NC=F approach was used).|||Percentage of participants|||Number
1327697|NCT02137772|Secondary|Percentage of Participants With CMV End-organ Disease up to Week 14 Post-transplant|CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.|Up to Week 14 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. A participant with a missing value up to Week 14 was excluded from the analysis (i.e., Data as observed [DAO] approach was used).|||Percentage of participants|||Number
1327698|NCT02137772|Secondary|Percentage of Participants With CMV End-organ Disease up to Week 24 Post-transplant|CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.|Up to Week 24 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. A participant with a missing value up to Week 24 was excluded from the analysis (i.e., Data as observed [DAO] approach was used).|||Percentage of participants|||Number
1327699|NCT02137772|Secondary|Percentage of Participants With Clinically-significant CMV Infection up to Week 14 Post-transplant|Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.|Up to Week 14 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 14-week visit window were considered treatment failure (i.e. NC=F approach was used).|||Percentage of participants|||Number
1327700|NCT02137772|Secondary|Time to Onset of Clinically-significant CMV Infection (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)|Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. Time to onset of clinically-significant CMV infection was defined from the day of transplantation to the day the participant developed clinically-significant CMV infection, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not develop clinically-significant CMV infection.|Up to Week 24 post-transplant|All randomized participants who received at least one dose of study drug and had no detectable CMV viral DNA on the day treatment was initiated.|||Percentage of participants||95% Confidence Interval|Number
1327701|NCT02137772|Primary|Percentage of Participants With Clinically-significant CMV Infection up to Week 24 Post-transplant|Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.|Up to Week 24 post-transplant|The Full Analysis Set (FAS) was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1 (randomization). Participants who prematurely discontinued or had a missing outcome through the 24-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used).|||Percentage of participants|||Number
1327702|NCT02137603|Secondary|Thirty Day Complication Rate|Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation|Thirty days||||participants|||Number
1327703|NCT02137603|Primary|Post Operative Length of Stay||Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours||||Hours||Standard Deviation|Mean
1327704|NCT02137512|Other Pre-specified|Reported Adverse Events|Reported adverse events during the 5-month extension phase.|Extension phase 5-month period||2016-08-31|08/2016||||
1327705|NCT02137512|Other Pre-specified|Episodes of Severe Hypoglycemia Events|Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327706|NCT02137512|Other Pre-specified|Episodes of DKA Events|Episodes of DKA events that occurred during the 5-month extension phase.|Extension phase 5-month period||2016-08-31|08/2016||||
1327707|NCT02137512|Other Pre-specified|Glucose Coefficient of Variation (CV)|Glucose coefficient of variation in CGM measured glucose values over the course of the 5-month extension phase.|Extension phase 5-month period||2016-08-31|08/2016||||
1327708|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >300 mg/dL|Percentage of CGM measured glucose values >300 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327709|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >250 mg/dL|Percentage of CGM measured glucose values >250 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327710|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values >180 mg/dL|Percentage of CGM measured glucose values >180 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327711|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values 70-180 mg/dL|Percentage of CGM measured glucose values 70-180 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327712|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <70 mg/dL|Percentage of CGM measured glucose values <70 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327713|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <60 mg/dL|Percentage of CGM measured glucose values <60 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327714|NCT02137512|Other Pre-specified|Percentage of CGM Measured Glucose Values <50 mg/dL|Percentage of CGM measured glucose values <50 mg/dL in the 5-month extension phase of study system use at home in day+night closed-loop configuration.|Extension phase 5-month period||2016-08-31|08/2016||||
1327715|NCT02137512|Other Pre-specified|Mean CGM Sensor Glucose|Mean glucose during study system use at home during the extension phase in day+night closed-loop configuration|Extension phase 5-month period||2016-08-31|08/2016||||
1327716|NCT02137512|Other Pre-specified|Change in HbA1c|Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase.|Extension phase 5-month period||2016-08-31|08/2016||||
1327717|NCT02137512|Secondary|High Blood Glucose Index (HBGI)|High blood glucose index (HBGI) in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period. HBGI is a metric specifically designed to calculate the risk for hyperglycemia as reflected by blood glucose data. The HBGI is a non-negative quantity that increases when the number and/or extent of high blood glucose readings increases.|2-weeks|One participant was excluded due to missing baseline CGM data.|||[ln(mg/dL)]^1.084||Inter-Quartile Range|Median
1327718|NCT02137512|Secondary|Area Under the Curve (AUC) Glucose >180 mg/dL|Area under the Curve (AUC) glucose >180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.|||mg/dL * hours||Inter-Quartile Range|Median
1327719|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values >180 mg/dL|Percentage of time CGM measured glucose values >180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.|||percentage of sensor hours||Inter-Quartile Range|Median
1327720|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values >250 mg/dL|Percentage of time CGM measured glucose values >250 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.|||percentage of sensor hours||Inter-Quartile Range|Median
1327856|NCT02135029|Secondary|Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1327721|NCT02137512|Secondary|Low Blood Glucose Index (LBGI)|Low blood glucose index (LBGI) in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period. LBGI is a metric specifically designed to calculate the risk for hypoglycemia as reflected by blood glucose data. The LBGI is a non-negative quantity that increases when the number and/or extent of low blood glucose readings increases.|2-weeks|One participant was excluded due to missing baseline CGM data.|||[ln(mg/dL)]^1.084||Inter-Quartile Range|Median
1327722|NCT02137512|Secondary|Area Under the Curve (AUC) Under 180 mg/dL|Area under the Curve (AUC) under 180 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data|||mg/dL * hours||Inter-Quartile Range|Median
1327723|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values <50 mg/dL|Percentage of time CGM measured glucose values <50 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.|||percentage of sensor hours||Inter-Quartile Range|Median
1327724|NCT02137512|Secondary|Percentage of Time CGM Measured Glucose Values <60 mg/dL|Percentage of time CGM measured glucose values <60 mg/dL in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data|||percentage of sensor hours||Inter-Quartile Range|Median
1327725|NCT02137512|Secondary|Glucose Coefficient of Variation|Measure of CGM glucose variability in the 2 weeks of study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.|||percentage||Inter-Quartile Range|Median
1327726|NCT02137512|Secondary|Percentage of Time Sensor Glucose Values 70 to 180 mg/dL|Percentage of time sensor glucose values 70 to 180 mg/dL during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data|||percentage of sensor hours||Inter-Quartile Range|Median
1327727|NCT02137512|Secondary|Mean Glucose|Mean glucose during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data.|||mg/dl||Standard Deviation|Mean
1327728|NCT02137512|Secondary|Time Spent in Hypoglycemia- Overnight Closed-loop Only|Percent median time spent with sensor glucose ≤70 mg/dl during study system use at home in closed-loop configuration at night only when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data|||percentage of hours||Inter-Quartile Range|Median
1327729|NCT02137512|Primary|Time Spent in Hypoglycemia- 24 Hour Closed Loop|Percent median time spent with sensor glucose ≤70 mg/dl during study system use at home in day+night closed-loop configuration when compared with the 2-weeks baseline sensor-augmented pump period.|2-weeks|One participant was excluded due to missing baseline CGM data|||percentage of hours||Inter-Quartile Range|Median
1327730|NCT02137447|Secondary|Composite Secondary Outcomes of Non-infectious Abdominal Wound Complications, Damage to the Skin Caused by the Dressing, Need to End the Treatment Prior to Discharge or Prior to 5-7 Post-operative Days, and Need for Reapplication of the System.|"Secondary (composite) outcomes:~other non infectious abdominal wound complications,~damage to the skin caused by the dressing~need to end the treatment prior the discharge OR prior to 5 -7 post- operative days.~need for re-application of the system for any reason"|4 weeks||||Participants|||Count of Participants
1327731|NCT02137447|Primary|Number of Participants With Surgical Site Infections Within 1 Month (4 Weeks ) From Index Operation|Incidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network|30 days||||Participants|||Count of Participants
1327732|NCT02137382|Secondary|Percentage of Days With Formed/Normal Stools|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/ number of days recorded in diary).|5 days|Per protocol|||percentage of days||Standard Deviation|Mean
1327733|NCT02137382|Secondary|Percentage of Days With no Abdominal Pain|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain/ number of days recorded in diary).|5 days|Per protocol|||percentage of days||Standard Deviation|Mean
1327734|NCT02137382|Secondary|Percentage of Days With no Flatulence|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary).|5 days|Per protocol|||percentage of days||Standard Deviation|Mean
1327735|NCT02137382|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period|5 days|Per protocol|||number of stools per day||Standard Deviation|Mean
1327736|NCT02137382|Secondary|Total Fat Excretion|Total amount of fat excreted during the stool collection period in grams.|5 days|Per protocol|||Grams||Standard Deviation|Mean
1327737|NCT02137382|Secondary|Coefficient of Nitrogen Absorption (CNA).|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|5 days|Per protocol|||percentage of nitrogen intake||Standard Deviation|Mean
1327738|NCT02137382|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|5 days|Per protocol|||percentage of fat intake||Standard Deviation|Mean
1327746|NCT02136914|Secondary|Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24|The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.|Baseline to Week 24|MITT population|||units on a scale||Standard Error|Least Squares Mean
1327857|NCT02135029|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1327739|NCT02137226|Primary|The Proportion of Patients Meeting ACR20 Response Criteria at Week 24|ACR20 at Week 12 and Week 24 are standard outcome criteria that are widely accepted for regulatory purposes to demonstrate efficacy in treating the signs and symptoms of Rheumatoid arthritis (RA). The proportion of patients meeting the ACR20 response criteria was assessed at Week 12 and Week 24 to provide a robust comparison with US-licensed Humira® data. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient’s assessment of pain, Patient’s global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score ([DAS]), Physician’s global assessment of disease activity, Patient’s assessment of physical function, as measured by the Health Assessment Questionnaire – Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein [CRP]).|Week 24|Full Analysis Set. Patients who discontinued treatment prior to the time-point had their binary response imputed as non-responder, a method commonly known as non-responder imputation. For truly missing data at the component level, multiple imputation was used.|||Percentage of Patients|||Number
1327740|NCT02137226|Secondary|The Percentage of Patients With Investigator-assessed Drug-related Adverse Events (AEs) During the Treatment Phase|The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator-assessed drug related AEs were AEs with a relationship to drug ticked “yes” according to the Investigator. Overall results are presented from Day 1 up to Week 58 and are based on the initial randomization groups. The comparison therefore focuses on patients who received BI 695501 continuously versus patients who received Humira® continuously for the long term assessment of safety. One patient was initially treated with Humira and discontinued prior to Week 24. This patient was mistakenly re randomized to BI 695501 but not treated. For safety this was counted in Humira not re-randomized group (as treated), and for other analysis sets, this patient was counted in the Humira to BI 695501 group (as randomized).|From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks|The Safety Analysis Set contained all patients who received at least one dose of trial drug.|||Percentage of Patients|||Number
1327741|NCT02137226|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 and Week 24|"The DAS28 (ESR) score was derived using the following formulae:~DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.7*ln(ESR)~Where:~TJC28 = 28 joint count for tenderness~SJC28 = 28 joint count for swelling~Ln (ESR) = natural logarithm of ESR~GH = General Health component of the DAS (patient’s global assessment of disease activity). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Actual number of patient analysed (N) is mean number of subjects in the analysis set with DAS28(ESR) results computable across the multiply imputed data sets. It is 319.6, 317.1 for week 12 and 313.9, 315.1 for week 24 for BI 695501 and US-licensed Humira® respectively."|Baseline, Week 12 and Week 24|Full Analysis Set. Patients who discontinued treatment prior to the time-point had their binary response imputed as non-responder, a method commonly known as non-responder imputation. For truly missing data at the component level, multiple imputation was used.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1327742|NCT02137226|Primary|The Proportion of Patients Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 12|The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient’s assessment of pain, Patient’s global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score (DAS)), Physician’s global assessment of disease activity, Patient’s assessment of physical function, as measured by the Health Assessment Questionnaire – Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein (CRP)).The Full Analysis Set contained all enrolled patients who were randomized to trial drug and who received at least one dose of trial drug and had all efficacy measures relevant for the co-primary efficacy endpoints measured at baseline and at least once post- baseline.|Week 12|Full Analysis Set. Patients who discontinued treatment prior to the time-point had their binary response imputed as non-responder, a method commonly known as non-responder imputation. For truly missing data at the component level, multiple imputation was used.|||Percentage of Patients|||Number
1327743|NCT02136914|Secondary|Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms|The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24.|Baseline to Week 12 and Week 24|MITT population|||Participants|||Count of Participants
1327744|NCT02136914|Secondary|Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)|The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each Part contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD.|Baseline (BL) to Week 12 (W12) and Week 24 (W24)|MITT population|||units on a scale||Standard Error|Least Squares Mean
1327745|NCT02136914|Secondary|Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)|A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 8, 12, 18, and 24 visits.|Baseline (BL) to Week 12 (W12) and Week 24 (W24)|MITT population|||hours||Standard Error|Least Squares Mean
1327770|NCT02136004|Primary|Time to Hemostasis|Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis|procedural, usually within 15 minutes of enrollment|All subjects enrolled|||minutes||95% Confidence Interval|Mean
1327747|NCT02136914|Primary|Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12|The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.|Baseline to Week 12|MITT population|||units on a scale||Standard Error|Least Squares Mean
1327748|NCT02136498|Secondary|Number of Days of Varenicline Use|Number of days varenicline was used|5 mo follow-up||||Mean number of days||Standard Deviation|Mean
1327749|NCT02136498|Primary|Point Prevalence Abstinence|Self-report of no-smoking, even a puff during the last 7 days.|5 month follow-up|Intent to treat analyses with missing cases imputed as smokers.|||Percentage of people not smoking|||Number
1327750|NCT02136420|Primary|Percent Change in Manual Control Performance After Exposure to Hypogravity|"Note that this applies to arms 6-9 only.~Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects completed a manual control task in which their charge was randomly perturbed in roll tilt, and they used a joystick to attempt to keep themselves aligned with upright, while in the dark. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We calculated their performance by calculating the standard deviation of chair position across time, with a smaller number indicating better performance. Then we calculated the percent change in their performance between 1 Gz and 0.5 Gz."|1 session||||percentage change||Standard Deviation|Mean
1327751|NCT02136420|Primary|Interaural Perceptual Motion Threshold|"This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Interaural translation refers to translations in the horizontal plane to the subject's left or right.~This outcome measure applies only to arm 5 subjects."|2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication||||cm per sec||Standard Deviation|Geometric Mean
1327752|NCT02136420|Primary|Roll Perceptual Motion Threshold|"This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Roll tilt means rotations about an axis that is Earth-horizontal.~This outcome measure applies only to arm 5 subjects."|2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication||||deg per sec||Standard Deviation|Geometric Mean
1327753|NCT02136420|Primary|Yaw Perceptual Motion Threshold|"This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Yaw rotation means rotations about an axis that is perpendicular to gravity.~This outcome measure applies only to arm 5 subjects."|2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication||||deg per sec||Standard Deviation|Geometric Mean
1327754|NCT02136420|Primary|Percent Change in Roll Tilt Perception After Exposure to Hypogravity|"Note that this applies to arms 1-4 only.~Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects were repeatedly roll tilted to angles between 11 and 19 degrees, and then reported their perceived tilt angle using a subjective visual vertical task. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We hypothesized that, after entering hypogravity, subjects would tend to underestimate their tilt angle. We calculated the percent change in their perception of tilt between 1 Gz and 0.5 Gz."|1 session||||percentage change||Full Range|Mean
1327755|NCT02136238|Primary|Physical Function Performance 10 Test Score|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.||||units on a scale||Standard Deviation|Mean
1327756|NCT02136238|Primary|Sternal Displacement During Towel Folding Task|Distance sternum is displaced while folding a towel was measured in meters.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.||||meters||Standard Deviation|Mean
1327757|NCT02136134|Secondary|Overall Survival (OS)|Overall Survival was measured from the date of randomization to the date of the participant's death.|Up to the end of the study (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
1327758|NCT02136134|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1327771|NCT02135900|Primary|Mean Oxygen Saturation (M SO2)|Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Percentage of oxygen saturation||95% Confidence Interval|Mean
1327759|NCT02136134|Secondary|Overall Response Rate (ORR)|The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Up to disease progression (approximately of 3 years)|The response-evaluable analysis set is defined as participants who have confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment and had at least 1 post baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1327760|NCT02136134|Secondary|Percentage of Participants With a Very Good Partial Response (VGPR) or Better|Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The response evaluable analysis set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment, and had at least 1 post baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1327761|NCT02136134|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
1327762|NCT02136134|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
1327763|NCT02136004|Secondary|Procedure Success|Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days|through 30 days +/- 7 days|All subjects enrolled.|||Participants|||Count of Participants
1327764|NCT02136004|Secondary|Rate of Combined Minor Access Site Closure-related Complications|Secondary safety endpoint - rate of combined minor access site closure-related complications|through 30 +/- 7 days|All subjects enrolled|||complications|||Number
1327765|NCT02136004|Secondary|Device Success|Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression|procedural, usually within 15 minutes of enrollment|All subjects enrolled|||Participants|||Count of Participants
1327766|NCT02136004|Secondary|Time to Hospital Discharge|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward|through hospital discharge, usually within 24 hours|All subjects enrolled|||hours||95% Confidence Interval|Mean
1327767|NCT02136004|Secondary|Time to Discharge Eligibility|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)|prior to hospital discharge, usually within 24 hours|All subjects enrolled|||hours||95% Confidence Interval|Mean
1327768|NCT02136004|Secondary|Time to Ambulation|Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site|prior to hospital discharge, usually within 24 hours|All subjects enrolled|||hours||95% Confidence Interval|Mean
1327769|NCT02136004|Primary|Rate of Combined Major Access Site Closure-related Complications|Primary safety endpoint - rate of combined major access site closure-related complications|Through 30 days +/- 7 days|All subjects enrolled|||complications|||Number
1327773|NCT02135900|Primary|Apnea Index (AI)|Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Number of apneas per hour sleep||95% Confidence Interval|Mean
1327774|NCT02135900|Primary|Apnea Hypopnea Index|Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Apneas or hypopneas per hour sleep||95% Confidence Interval|Mean
1327775|NCT02135848|Secondary|Relationship of Pharmacokinetic Parameters to the Pharmacodynamic Assessments Performed in This Study|A formal pharmacokinetic /pharmacodynamic analysis and pharmacokinetic /pharmacodynamic modelling for exposure relationships to endpoints was planned. The data for this outcome was not collected.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|The data for this outcome measure was not collected.||||||
1327776|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter - Time to Maximum Plasma Concentration (T-max) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last)|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
1327777|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter -Area Under the Curve (AUC [0-t])|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration Population. Only those participants available at the specified time points were analyzed.|||Nanogram x hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1327778|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter- Maximum Plasma Concentration (Cmax) and Trough Concentration (Ctau)|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration population comprised of all participants from whom a pharmacokinetic sample had been obtained and analyzed. Only those participants available at the specified time points were analyzed.|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1327779|NCT02135848|Secondary|Change From Baseline in Lipids (Total Cholesterol [TC], Triglycerides [TG], High Density Lipoprotein Cholesterol [HDLc] and Low Density Lipoprotein Cholesterol [LDLc])|Blood samples for analysis of fasting levels of lipid panel (TC, TG, HDLc and LDLc) was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Millimoles/Liter (MMOL/L)||Standard Deviation|Mean
1327780|NCT02135848|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Blood samples for analysis of fasting levels of hsCRP, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Milligrams/Liter (mg/L)||Standard Deviation|Mean
1327781|NCT02135848|Secondary|Change From Baseline in Hematocrit|Blood samples for analysis of fasting levels of hematocrit was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
1327782|NCT02135848|Secondary|Change From Baseline in Hemoglobin|Blood samples for analysis of fasting levels of hemoglobin was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Grams per Liter||Standard Deviation|Mean
1327783|NCT02135848|Secondary|Change From Baseline in Erythropoietin Concentration|Blood samples for analysis of fasting levels of erythropoietin, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Units per Liter||Standard Deviation|Mean
1327836|NCT02135445|Primary|Percentage of Participants With Effective Castration Rate Over 25 Weeks|Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits.|Day 1 Week 5 up to Day 1 Week 25|Safety population included all participants who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1327784|NCT02135848|Secondary|Change From Baseline in the Maximal Distance Covered During a Six-Minute Walk Test|The Six-Minute Walk Test was performed by the participant walking at a self-selected pace for 6 minutes through a pre-defined walking course. When the Six-Minute Walk Test and Bilateral Heel Raise Test were conducted at the same study visit, the participant was allowed to rest a minimum of one hour between these tests. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Feet||Standard Deviation|Mean
1327785|NCT02135848|Secondary|Change From Baseline in Total Exercise Time to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||seconds||Standard Deviation|Mean
1327786|NCT02135848|Secondary|Change From Baseline in Total Work Performed to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||kilogram-meters||Standard Deviation|Mean
1327787|NCT02135848|Secondary|Change From Baseline in Total Number of Contractions to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Contractions||Standard Deviation|Mean
1327788|NCT02135848|Secondary|Change From Baseline in Total Exercise Time to Onset of Claudication|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Seconds||Standard Deviation|Mean
1327789|NCT02135848|Secondary|Change From Baseline in Total Work Performed to Onset of Claudication|BHRT is a method to assess muscle performance in participants with claudication. Participants with peripheral artery disease (PAD) and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to BHRT. Test familiarization consisted of the participant performing heel raises to onset of claudication. BHRT was conducted with an electrogoniometer instrumented on the index leg (leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until participant stopped due to intolerable claudication pain/fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||kilogram-meters||Standard Deviation|Mean
1327837|NCT02135432|Other Pre-specified|Pharmacokinetics as Described by AUC12 of Subjects Receiving Ivacaftor||baseline to 2 weeks|||||||
1327852|NCT02135029|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24||Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
1327790|NCT02135848|Secondary|Change From Baseline in Total Number of Contractions to Onset of Claudication|At Visit 1 (-21 to -10 days), the participant was introduced to the bilateral heel raise test (BHRT). Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg. Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. The index leg was defined as the leg that met the inclusion symptomatic and hemodynamic criteria (ankle brachial index [ABI] ≤ 0.90) with the lowest ABI considered if both legs were affected. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population comprised of all participants who provided pharmacodynamic data, i.e. bilateral heel-raise data or six-minute-walk-test data. Only those participants with data available at the indicated time points were analyzed.|||Contractions||Standard Deviation|Mean
1327791|NCT02135848|Primary|Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance|Hematology parameters included platelet count, red blood cell (RBC) count, white blood cell WBC count (absolute), hemoglobin, hematocrit, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with clinical hematology abnormalities of potential clinical importance are presented.|Up to 67 days|Safety Population.|||Participants|||Count of Participants
1327792|NCT02135848|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|Clinical chemistry analyte of potential clinical concern included albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium and bicarbonate. Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to 67 days|Safety Population.|||Participants|||Count of Participants
1327793|NCT02135848|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital signs included heart rate, systolic and diastolic blood pressure and were performed with the participant in a supine position after the participant had rested for at least 5 minutes. Number of participants with vital signs of potential clinical importance are presented.|Up to 39 days|Safety Population.|||Participants|||Count of Participants
1327794|NCT02135848|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve lead ECGs were recorded with the participant lying supine, having rested in this position for at least 5 minutes before each recording. Full 12 lead ECGs were recorded using an ECG device that automatically calculated the heart rate and measured PR, QRS, RR, QT and QT, QT corrected by Bazett's formula (QTcB) and QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant [NCS] and clinically significant [CS]) ECG findings are presented.|Up to 39 days|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1327795|NCT02135848|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 67 days|Safety population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1327796|NCT02135692|Secondary|Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline|"Blood samples were collected to assess hematology laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category."|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327797|NCT02135692|Secondary|Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline|"Blood samples were collected to assess clinical chemistry laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category. Alanine Aminotransferase=ALT. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)."|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327798|NCT02135692|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)|Blood samples were collected for the determination of ADA just prior to administration of mepolizumab. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. The highest value post-Baseline visit are based on each participant's highest post-Baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-Baseline would be positive for a participant who had both negative and positive post-Baseline results. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327855|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ratio||Standard Deviation|Mean
1327799|NCT02135692|Secondary|Change From Baseline in Pulse Rate|Vital sign measurements including pulse rate was done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|Baseline (Week 0) to Week 168|AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Beats per minute||Standard Deviation|Mean
1327800|NCT02135692|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|Baseline (Week 0) to Week 168|AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Millimeter of mercury||Standard Deviation|Mean
1327801|NCT02135692|Secondary|Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline|Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Participants with maximum change from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327802|NCT02135692|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG)|Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)..|Baseline (Week 0) to Week 172|AT Population|||Milliseconds||Standard Deviation|Mean
1327803|NCT02135692|Secondary|Number of Participants With AEs Including Both Systemic (Allergic and Non-allergic) and Local Site Reactions|AEs were collected from the Baseline visit until the follow-up visit (Week 172). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. Number of participants with AEs including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions have been presented.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327804|NCT02135692|Secondary|Number of Participants Hospitalized Due to Adverse Events Including Asthma Exacerbations|AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327805|NCT02135692|Secondary|Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events|AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Number of participants withdrawn due to lack of efficacy and adverse events from the study have been presented.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327806|NCT02135692|Secondary|Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline and Weeks 24, 48, 72, 96, 120, 144 and 168. Spirometry was performed within 1 hour of the Baseline assessment. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Data between first dose date and earliest of Withdrawal date/last dose + 28 days considered on-treatment.|Baseline (Week 0) to Week 168|AT Population|||Milliliter||Standard Deviation|Mean
1327853|NCT02135029|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24||Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
1327807|NCT02135692|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score|The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|Baseline (Week 0) to Week 168|AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
1327808|NCT02135692|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose+28 days.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
1327809|NCT02135692|Primary|Annualized Rate of On-treatment Exacerbations Per Year|Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids intravenous (IV) or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. On-Treatment data between first dose date and earliest of Withdrawal date/last dose + 28 days was considered for analysis. Analysis of the number of exacerbations was performed using a negative binomial generalized linear model.|Baseline (Week 0) to Week 172|As Treated (AT) Population. AT Population included all participants who received at least one dose of mepolizumab within study 201312.|||Exacerbations per year||95% Confidence Interval|Mean
1327810|NCT02135614|Secondary|Rate of Unplanned Medical Encounters|The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.|Up to Day 28|Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.|||encounters per participant||95% Confidence Interval|Number
1327811|NCT02135614|Secondary|Number of Hospitalization-Free Days Following Presatovir Administration||Up to Day 28|Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.|||days||Inter-Quartile Range|Median
1327812|NCT02135614|Secondary|Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5|The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.|Baseline to Day 5|Participants in the Evaluable Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
1327813|NCT02135614|Primary|Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5|The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.|Baseline to Day 5|Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.|||log10 copies/mL||Standard Error|Mean
1327814|NCT02135445|Secondary|Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score|EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Baseline and last post-baseline value up to Week 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||units on scale||Standard Error|Least Squares Mean
1327838|NCT02135432|Secondary|Change in COPD as Measured by Change in Percentage of FEV1 as Measured in Each Group|Spirometry will be analyzed by ATS criteria, and the best of three reproducible efforts will be used to calculate FEV1 in comparison to Hankinson standards. The primary analysis will be the change in FEV1% from day 0 to day 14 within subject, and will be tested against the null hypothesis that no change occurs using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks||||percentage of FEV1||Standard Deviation|Mean
1327815|NCT02135445|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'Very poor' to 7 'Excellent'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.|Baseline and last post-baseline value up to Week 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||units on scale||Standard Error|Least Squares Mean
1327816|NCT02135445|Secondary|Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score|AMS scale is a self-administered questionnaire used to 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between none (1) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.|Day 1 of Weeks 5, 13, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||percent change||Standard Deviation|Mean
1327817|NCT02135445|Secondary|Serum Sex Hormone-Binding Globulin (SHBG) Level||Baseline, Day 1 of Week 2, 5, 13, 25 and 29|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||nmol/L||Standard Deviation|Mean
1327818|NCT02135445|Secondary|Serum Follicle-Stimulating Hormone (FSH) Level||Baseline, Day 1 of Week 2, 5, 13, 25 and 29|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||International units per liter (IU/L)||Standard Deviation|Mean
1327819|NCT02135445|Secondary|Serum Luteinizing Hormone (LH) Level||Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||milli-international units per milliliter||Standard Deviation|Mean
1327820|NCT02135445|Secondary|Plasma Concentrations of TAK-385||Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dose|Safety population where TAK-385 assessments were available. Safety population included all participants who received at least one dose of study medication.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1327821|NCT02135445|Secondary|Serum PSA Concentration||Day 1 of Week 13, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||mcg/L||Standard Deviation|Mean
1327822|NCT02135445|Secondary|PSA Nadir||Baseline up to Day 1 Week 25|Safety population included all participants who received at least one dose of study medication.|||microgram per liter (mcg/L)||Standard Deviation|Mean
1327823|NCT02135445|Secondary|Percent Change From Baseline in Serum PSA Concentration||Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||percent change||Standard Deviation|Mean
1327824|NCT02135445|Secondary|Number of Participants With PSA Response of >=50% and >=90% Reduction|Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.|Day 1 Week 13|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
1327825|NCT02135445|Secondary|Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone||Day 1 Week 25 up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1327826|NCT02135445|Secondary|Percentage of Participants Who Have Recovered to Baseline Value of Testosterone||Up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1327827|NCT02135445|Secondary|Estimated Time to Testosterone Recovery (TTR)|TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or >280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT).|Up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
1327828|NCT02135445|Secondary|Time to Achieve Profound Castration|Time to profound castration is defined as days from first dose to first testosterone measurement that is <20 ng/dL.|Baseline up to Week 37|Safety population included all participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
1327829|NCT02135445|Secondary|Time to Achieve Effective Castration|Time to effective castration is defined as days from first dose to first testosterone measurement that is <50 ng/dL.|Baseline up to Week 37|Safety population included all participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
1327830|NCT02135445|Secondary|Average Percent Change in Prostate Size|Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13.|Baseline, Day 1 Week 9 to Day 1 Week 13|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||percent change||Standard Deviation|Mean
1327831|NCT02135445|Secondary|Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
1327840|NCT02135432|Secondary|Change in COPD as Measured by Nasal Potential Difference|Evaluate the efficacy of ivacaftor treatment in patients with COPD including measures of CFTR activity and clinical outcome as measured by change in nasal potential difference measurement in each group. These data will be used to test the null hypothesis of no change in nasal potential difference (ΔLow Chloride plus isoproterenol) using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks||||millivolts||Standard Deviation|Mean
1327841|NCT02135432|Primary|Change in COPD as Measured by the Sweat Analysis in Each Group|sweat analysis is measured by performing a sweat test in each participant. The primary analysis will compare the within group change in sweat chloride before (day 1) and after (day 14) ivacaftor or placebo administration and will be used to test the null hypothesis of no change in sweat chloride using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks|8 patients were analyzed in the ivacaftor Arm because 8 patients were randomized to study drug and only 4 patients were randomized in the placebo arm because 4 patients received placebl|||mmol/L||Standard Deviation|Mean
1327842|NCT02135094|Secondary|Comparison of Pain Level Using Global Rating of Change (GROC) Scale.|"Participants were asked to report how their body feels overall compared to the day before, on days when the ultrasound device (or placebo) were applied. The score was reported after the 4-hour treatment completion and rated on a 15-point global rating of change scale, with -7 being a very great deal worse than the day before, 0 being no change from the day before, and +7 being a very great deal better than the day before. The weekly average GROC and average GROC for the entire study (Overall) were assessed."|Week 1, Week 2, Week 3, Week 4, Overall||||units on a scale||Standard Deviation|Mean
1327843|NCT02135094|Secondary|Change in Pain Rated on Numeric Rating Scale (NRS) From Pre-treatment to 30 Minutes Into Treatment, 2 Hours Into Treatment, and Post-treatment (4 Hours Into Treatment)|The numeric rating scale (NRS) was used to assess pain before treatment, 30 minutes into treatment, 2 hours into treatment, and post-treatment. NRS range was from 0-10 with 0 being in no pain and 10 the worst pain possible. Change in pain was calculated by subtracting intra-treatment and post-treatment average scores from pre-treatment average score.|Day 1 through Week 4||||units on a scale||95% Confidence Interval|Mean
1327844|NCT02135094|Secondary|Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.|Participants recorded pain rated on the numeric rating scale (NRS) at 4 time points: before treatment, 30 minutes into treatment, 2 hours into treatment, and directly after treatment. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. The average time point scores across the study is used to assess pain during treatment.|Day 1 through Week 4||||units on a scale||Standard Deviation|Mean
1327845|NCT02135094|Primary|Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.|The Day 1 pre-treatment score was used to find the change in pain each week, rated on the numeric rating scale (NRS). NRS was rated from 0-10 with 0 being in no pain and 10 the worst pain possible. Weekly averaged post-treatment scores were subtracted from Day 1 pre-treatment score.|Day 1 through Week 1, Week 2, Week 3, and Week 4||||units on a scale||95% Confidence Interval|Mean
1327846|NCT02135094|Primary|Pain on the Numeric Rating Scale (NRS)|Patients applied the ultrasound device when trapezius muscle pain exceeds a score of 3 or higher by numeric rating scale (NRS). NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. Device maybe be worn safely for 4 h per day for 7 days a week. Participants recorded NRS score daily (pre-treatment) and on days when the device was applied participants recorded pain 30 minutes into treatment, 2 hours into treatment and post-treatment (after 4 hours). The post-treatment score is used to find the week average and standard deviation.|Week 1, Week 2, Week 3, Week 4||||units on a scale||Standard Deviation|Mean
1327847|NCT02135029|Secondary|Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations||Baseline (Day 1) up to Week 30|Safety analysis set included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1327848|NCT02135029|Secondary|Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively|Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.|Week 4, 12, 24 and 30 (Follow-up)|Safety analysis set: all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for the arm. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.|||titer||Standard Deviation|Mean
1327849|NCT02135029|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Participants with at least one positive ADA titer greater than or equal to (>=) 6.23 or positive nAb titer >=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.|Baseline up to Week 30|Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.|||participants|||Number
1327850|NCT02135029|Secondary|Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations||Baseline (Day 1) up to Week 30|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1327851|NCT02135029|Secondary|Plasma PF-04950615 Concentrations at Weeks 12 and 24|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter [mcg/mL]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.|Week 12 and 24|Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for the arm.|||mcg/mL||Standard Deviation|Mean
1327854|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ratio||Standard Deviation|Mean
1327859|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified timepoint for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1327860|NCT02135029|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1327861|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1327862|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1327863|NCT02135029|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327864|NCT02135029|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327865|NCT02135029|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327866|NCT02135029|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327867|NCT02135029|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline, Week 24|FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
1327868|NCT02135029|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327869|NCT02135029|Secondary|Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327870|NCT02135029|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327871|NCT02135029|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327872|NCT02135029|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1327873|NCT02135029|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percent (%) change||Standard Deviation|Mean
1327874|NCT02135016|Secondary|The Block Level of Epidural Anesthesia|The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).|20 mins after epidural anesthesia||||units on a scale||Standard Deviation|Mean
1327875|NCT02135016|Secondary|The Heart Rate|The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||beats per minute||Standard Deviation|Mean
1327876|NCT02135016|Secondary|The Mean Blood Pressure|The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||mmHg||Standard Deviation|Mean
1327908|NCT02134925|Primary|Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)|The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank‐Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.|Week 0 to week 12||||IgG ratio||Full Range|Median
1327877|NCT02135016|Secondary|The Bispectral Index|The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||units on a scale||Standard Deviation|Mean
1327878|NCT02135016|Primary|The Effect-site Concentration of Propofol|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||µg/ml||Standard Deviation|Mean
1327879|NCT02134977|Secondary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event was occurred in breast cancer female.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.|||participants|||Number
1327880|NCT02134977|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.|||participants|||Number
1327881|NCT02134977|Secondary|Percentage of Participants With Positive Change in Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was the change in agents good? and the options of the answers were very good, somewhat good, whether or not the change in agents was good cannot be determined, somewhat bad, very bad."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
1327882|NCT02134977|Secondary|Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in pain at the time of injection due to the change in agents? and the options of the answers were significantly relieved, slightly relieved, whether or not the pain worsened or was relieved cannot be determined, worsened slightly, and worsened significantly."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
1327883|NCT02134977|Secondary|Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in adverse drug reactions (e.g., menopausal-like symptoms such as hot flushes, injection-site abnormalities) due to the change in agents? and the options of the answers were events became much less severe, events became less severe, whether or not the events became severe cannot be determined, events became slightly more severe, and events became very severe."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
1327884|NCT02134977|Secondary|Percentage of Participants Who Worried About the Effect of the Medicinal Agent|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you worry about the effect? and the options of the answers were not at all worried, not too worried, no thought either way, somewhat worried, and very worried."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
1327885|NCT02134977|Secondary|Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did you feel relief from financial burden (example, 3 months’ drug costs and transportation fee) due to the change in agents? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief. The sum of all the categories is not 100% because of rounding error."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
1327886|NCT02134977|Secondary|Percentage of Participants Who Felt Relief From Physical and Emotional Burden|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you feel relief from physical and emotional burden? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
1327909|NCT02134717|Secondary|Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells|CCR5 expression among these immune effector cells before and after CCR5 inhibition.|6 weeks|Study was terminated before data were collected for this outcome measure.||||||
1327910|NCT02134717|Secondary|Mononuclear Cell (MNC) Activation and T-cell Differentiation|MNC activation and T-cell differentiation before and after CCR5 inhibition.|6 weeks|Study was terminated before data were collected for this outcome measure.||||||
1327887|NCT02134977|Secondary|Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did the change in agents reduce the frequency of your medical visits? and the answers were categorized as very much reduced, somewhat reduced, unchanged. Change in medicinal agents means participants with a historical diagnosis of premenopausal breast cancer who switched to leuprorelin acetate sustained-release 11.25 mg injection kit from a 4-week adjuvant therapy with a LH-RHa 1 month depot preparation as part of daily medical practice."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
1327888|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 48|Efficacy assessment population where Week 48 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327889|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 12|Efficacy assessment population where Week 12 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327890|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Baseline|Efficacy assessment population where baseline assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327891|NCT02134977|Primary|Score of QOL-ACD-B at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327892|NCT02134977|Primary|Score of QOL-ACD-B at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327893|NCT02134977|Primary|QOL-ACD Breast (QOL-ACD-B) Score at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score was calculated over score range 0-100 for item 1 to 18 as ((a sum of 18 items)/18-1)*25). Score for physical condition and pain was calculated over score range 0-100 for item 1 to 6 as ((a sum of 6 items)/6-1)*25)). Score for health-care and illness satisfaction was calculated over score range 0-100 for item 7 to 10 as ((a sum of 4 items)/4-1)*25)), where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327911|NCT02134717|Primary|Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc|General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage|6 weeks|Data could not be analyzed||||||
1327936|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||percent of red blood cells in blood||Standard Deviation|Mean
1327894|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 48|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327895|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 12|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale:5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327896|NCT02134977|Primary|Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
1327897|NCT02134951|Other Pre-specified|Pharmacological Blood-oxygen-level Dependent (pharmacoBOLD) Response|Compare changes inpharmacoBOLD in response to infusion of ketamine vs. placebo, as measured by resting state functional magnetic resonance imaging. Calculated by post-pre changes, with higher values indicating higher response|Day 14||||BOLD signal units||Standard Error|Mean
1327898|NCT02134951|Primary|Glutamate + Glutamine (Glx) Response|Compare changes in Glx response to infusion of ketamine vs placebo, as measured by proton magnetic resonance spectroscopy (¹H MRS). Calculated by post-pre changes in the Glx over creatinine ratios, with higher values indicating higher Glx/creatinine ratios.|Day 1|Glx response in 1st 15 minutes post ketamine|||Glx over creatinine ratio||Standard Error|Mean
1327899|NCT02134925|Other Pre-specified|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.||Up to 3 years|||||||
1327900|NCT02134925|Other Pre-specified|Establishment of a Biospecimen Repository Archive Including Live Cells, Plasma, and Germline DNA for Future Immunologic and Other Assays||Up to 3 years|||||||
1327901|NCT02134925|Other Pre-specified|Change in MUC1 Expression|Descriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post‐baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t‐tests.|Baseline to up to 3 years|||||||
1327902|NCT02134925|Other Pre-specified|Change in Levels of Circulating MDSC in Peripheral Blood Mononuclear Cells by Flow Cytometry|MDSC levels will be correlated with anti‐MUC1 antibody levels and adenoma recurrence. Descriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post‐baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t‐tests.|Baseline to up to 3 years|||||||
1327903|NCT02134925|Other Pre-specified|Anti‐MUC1 Antibody Titer by ELISA|Comparisons between MUC1 and placebo will be performed using a two‐sample t‐test or Wilcoxon rank sum test, as appropriate. All categorical variables will be analyzed using chi‐square tests or Fisher’s exact test.|At approximately week 156|||||||
1327904|NCT02134925|Secondary|Number of Patients With at Least a 2‐Fold Increase in the IgG Ratio|The frequency and percentage of patients with at least a 2‐fold increase in the IgG Ratio will be calculated and compared between the MUC1 vaccine and placebo. The Fisher’s exact test will be used.|At 12 weeks||||Participants|||Count of Participants
1327905|NCT02134925|Secondary|Incidence of Participant-reported Injection Site Reaction Collected Using the Participant Completed Vaccine Report Card|Descriptive statistics will be used to summarize these data and compare the data between study arms.|Up to 57 weeks||2019-11-30|11/2019||||
1327906|NCT02134925|Secondary|Booster Response|The key secondary endpoint for Part 2 will assess the booster response at week 55 vs. week 52 for the vaccine as compared to placebo.|At week 55||2019-11-30|11/2019||||
1327912|NCT02134587|Secondary|Quality of ADE Reports|Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form.|Two days|The subjects were assessed regarding pharmacovigilance´s skills prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in contribute on the improvement of the quality of information inserted on the form.|||percent of correctly filled forms||Full Range|Median
1327913|NCT02134587|Secondary|Knowledge (Awareness) Regarding Pharmacovigilance|Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals.|Two days|The subjects were assessed regarding pharmacovigilance´s knowledge prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in aware health professionals to report adverse drug events.|||percentage of right answers||Full Range|Median
1327914|NCT02134587|Primary|Absolute Number of ADE Reporting (Change Behavior of Health Professionals)|Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.|12 months|Before educational intervention, health professionals reported only three adverse drug events, related to therapeutic failure. However, after the study, the number of reports rise 70-fold, since subjects reported 165 medication errors, 26 adverse drug reactions, 18 quality deviations, 5 therapeutic failure and one off-label use.|||absolute number of adverse drug events|||Number
1327915|NCT02134522|Secondary|Changes in Two Hour Glucose|2 hour glucose measured by an oral glucose tolerance test done at baseline and 12 weeks. Data are presented as mg/dl.|baseline and 12 weeks||||mg/dl|||Number
1327916|NCT02134522|Primary|Changes in Hepatic Fat Content|Abdominal MRI to measure percent liver fat done at baseline and 12 weeks.|baseline and 12 weeks|Presented is the change from baseline to 12 weeks in a single patient.|||percentage of hepatic liver fat|||Number
1327917|NCT02134314|Other Pre-specified|Graft Survival|Number of Participants with Graft Survival at 90 Days Post-Transplant|Day 90 Post-transplant||||Participants|||Count of Participants
1327918|NCT02134314|Other Pre-specified|Rate of Acute Cellular Rejection (ACR)|Number of acute cellular and antibody mediated rejection episodes by day 90.|Up to 90 days post-transplant||||episodes|||Number
1327919|NCT02134314|Other Pre-specified|Patient Survival|Patient survival at 90 days post-transplantation|Up to 90 days post-transplant||||Participants|||Count of Participants
1327920|NCT02134314|Other Pre-specified|Overall Incidence of Serious Adverse Events|Overall incidence of serious adverse events in the C1INH and placebo groups, number of events.|Up to 9 months post-transplant||||events|||Number
1327921|NCT02134314|Secondary|Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)|"DGF Scale:~Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation >70%~Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of >70% with need for dialysis~Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation <70% with no need for dialysis~Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of <70% with need for dialysis."|First 7 days post-transplant||||Participants|||Count of Participants
1327922|NCT02134314|Secondary|Mean Number of Patients on Dialysis|Mean number of patients on dialysis at 15 to 30 days post-transplant|15 to 30 days post-transplantation||||Participants|||Count of Participants
1327923|NCT02134314|Secondary|24h Urine Output|24 hour urine output post-transplantation measured in milliliters|24 hours post-transplant||||milliliters||Standard Deviation|Mean
1327924|NCT02134314|Secondary|Creatinine Clearance|Creatinine clearance calculated based on serum creatinine, milliliters per minute.|Up to 90 days post-transplant||||ml/minute||Standard Deviation|Mean
1327925|NCT02134314|Secondary|Serum Creatinine|Mean serum creatinine on day 90 in mg/dL|Up to 90 days post-transplant||||mg/dL||Standard Deviation|Mean
1327926|NCT02134314|Primary|Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.|Mean quantity of dialysis sessions per patient in the first 7 days post transplant.|First 7 days post-transplant||||dialysis sessions||Standard Deviation|Mean
1327927|NCT02134314|Primary|Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.|Number of patients in the C1INH and placebo groups with serum creatinine reduction of < 30% from 24 to 48 hours post-transplant.|First 7 days post-transplant||||Participants|||Count of Participants
1327928|NCT02134314|Primary|Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.|The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia).|First 7 days post-transplant||||Participants|||Count of Participants
1327929|NCT02134314|Primary|Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.|Number of participants in the C1INH and placebo groups with serum creatinine >3mg/dL on postoperative day 5|First 7 days post-transplant||||Participants|||Count of Participants
1334065|NCT02029521|Secondary|C-Reactive Protein (CRP)|CRP was measured to determine if this test fell during the course of treatment.|6 months|All participants.|||milligrams per liter||Standard Deviation|Mean
1327937|NCT02134119|Secondary|Hematological Measures -Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||percent of red blood cells in blood||Standard Deviation|Mean
1327938|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||percent of red blood cells in blood||Standard Deviation|Mean
1327939|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||ng/mL||Standard Deviation|Mean
1327940|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||ng/mL||Standard Deviation|Mean
1327941|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||ng/mL||Standard Deviation|Mean
1327942|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||mU/mL||Standard Deviation|Mean
1327943|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||mU/mL||Standard Deviation|Mean
1327944|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||mU/mL||Standard Deviation|Mean
1327945|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||M/uL||Standard Deviation|Mean
1327946|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||M/uL||Standard Deviation|Mean
1327947|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||M/uL||Standard Deviation|Mean
1327948|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|35-days||||ml/kg/min||Standard Deviation|Mean
1327949|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|0-days (baseline)||||ml/kg/min||Standard Deviation|Mean
1327950|NCT02134015|Secondary|Part A: Objective Response Rate (ORR) in HRG Low Participants|"Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response or partial response~Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable."|by trial termination (at 20 months)|Evaluable participants in the full analysis set|||Participants|||Count of Participants
1327951|NCT02134015|Secondary|Part A: Objective Response Rate (ORR) in HRG High Participants|"Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response (CR) or partial response (PR)~Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response [in the order of CR, PR, stable disease (SD), and progressive disease (PD)] among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable."|by trial termination (at 20 months)|Evaluable participants in the full analysis set|||Participants|||Count of Participants
1327952|NCT02134015|Secondary|Part B: Key Secondary Efficacy Endpoint: PFS, TTD|PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (TTD, as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.|4 years|No participants were analyzed for Part B endpoints because the trial was terminated at the end of Part A.||||||
1327953|NCT02134015|Secondary|Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants|Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial|by trial termination (at 20 months)||||Participants|||Count of Participants
1327954|NCT02134015|Secondary|Part A: Overall Survival in HRG High Participants|Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial|by trial termination (at 20 months)||||Participants|||Count of Participants
1327955|NCT02134015|Primary|Part B: Overall Survival|Percentage of participants still alive at the end of Part B|4 years|No participants were analyzed for Part B endpoints because the trial was terminated at the end of Part A.||||||
1327956|NCT02134015|Primary|Part A: Progression Free Survival (PFS) in Heregulin-low Participants|"PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.~Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table."|by trial termination (at 20 months)||||months||80% Confidence Interval|Number
1327957|NCT02134015|Primary|Part A: Progression Free Survival (PFS) in Heregulin-high Participants|"PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.~Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table."|by trial termination (at 20 months)||||months||80% Confidence Interval|Number
1327958|NCT02133781|Other Pre-specified|To Investigate the Effects of Age and Vaccine Type on B-cell Responses to Influenza Vaccine||Day 0 to 28|||||||
1327959|NCT02133781|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1327960|NCT02133781|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
1327961|NCT02133664|Primary|Controlled Oral Word Association Test (COWAT)|The COWAT is a letter fluency test. Participants are asked to generate as many words as possible beginning with a particular letter of the alphabet during one minute. Alternate versions using 3 letters are used for each examination. The change in total number of words produced for the 3 letters from baseline to 12 weeks will be the outcome.|baseline to 12 weeks|Only participant who completed COWAT at both baseline and 12 weeks were analyzed|||words||Standard Deviation|Mean
1327962|NCT02133664|Primary|California Verbal Learning Test-II (CVLT-II)|"CVLT-II is a measure of verbal learning/memory. It is comprised of lists containing 16 words, each of which fit into one of four categories of shopping list items. Five trials are administered followed by presentation of a different list. Free and cued recall of the original list is assessed. The change in long delay free recall from baseline to 12 weeks will be the measurement used for outcome."|baseline to 12 weeks|Only participants who completed CVLT-II at baseline and 12 weeks were analyzed|||correct responses||Standard Deviation|Mean
1327963|NCT02133664|Primary|Stroop Color-Word Test|The Stroop test assess attention and executive function.The task consists of 3 tasks with only red, green, and blue colors used. The first task asks the subject to name the colors of spots on cards. If a subject can perform this task the second task is performed in which a subject must read the names of colors listed on cards (which are printed in congruent colors). In the third task, the subject is shown a series of words naming colors but the words and colors are mismatched; so the word “yellow” may be red, the word “blue” may be green and so forth. The subject is instructed to ignore the word and name the color. The subject will have the tendency to read the word rather than name the color, the so-called Stroop effect. This third part of the test is referred to as the interference condition and is the critical measurement. The change in time it takes to complete the interference from baseline to 12 weeks is the outcome measure.|baseline to 12 weeks|Analysis occurs only for participants who completed Stroop at both baseline and 12 weeks|||seconds||Standard Deviation|Mean
1327964|NCT02133664|Primary|Paced Auditory Serial Addition Task (PASAT)|The PASAT is a measure of working memory and sustained attention frequently used in multiple sclerosis treatment outcome studies. The examinee is presented with a series of numbers at 2 second intervals on an audiotape and responds by always adding the last two numbers on the tape before the next number is presented. The change in total number of correct responses from baseline to 12 weeks is the measurement for the outcome.|Baseline to 12 weeks|Only participants who completed PASAT at both baseline and 12 weeks were analyzed.|||correct responses||Standard Deviation|Mean
1327965|NCT02133534|Primary|Improved Counts of Endothelial Progenitor Cells|Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.|baseline, 30 days|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
1327966|NCT02133508|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality.|Up to 8 months|All eligible participants|||percentage of participants|||Number
1327967|NCT02133508|Secondary|Overall Survival|Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause.|Up to 8 months|All eligible participants|||months||95% Confidence Interval|Median
1327968|NCT02133508|Secondary|Progression-free Survival (PFS) According to RECIST v1.1|PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants|||days||95% Confidence Interval|Median
1327969|NCT02133508|Primary|Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants|||percentage of participants|||Number
1327970|NCT02133508|Primary|Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants|||percentage of participants|||Number
1327971|NCT02133352|Secondary|Change in BNP Cardiac Biomarker|"Assess the change from baseline in BNP cardiac biomarkers after 180 days of twice daily ranolazine.~Cardiac biomarkers may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days||||pg/mL||Standard Deviation|Mean
1327972|NCT02133352|Secondary|Change in Echocardiogram Parameters (LVEF)|"To assess the changes from baseline in echocardiographic parameters (left ventricular geometry and function, LVEF, evidence of diastolic dysfunction, SPAP, right ventricular geometry and function, degree of tricuspid regurgitation) after 180 days of twice daily ranolazine.~An additional echo may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days||||LVEF %||Standard Deviation|Mean
1327973|NCT02133352|Secondary|Change in Cardiac Size and Function|"Assess changes from baseline in measurements of cardiac size and function obtained by MRI after 180 days of twice daily ranolazine.~An additional MRI may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days||||% ejection fraction||Standard Deviation|Mean
1327974|NCT02133352|Secondary|6 Minute Walk Test (6MWT)|Assess the change from baseline in 6 minute walk test (6MWT) after 180 days of twice daily ranolazine Optional follow up for some patients also includes 6MWT.|180 days||||meters||Standard Deviation|Mean
1327975|NCT02133352|Secondary|Percent Change in Other Hemodynamic Parameters|"Assess % change in other hemodynamic parameters, by RHC, from baseline afeter 180 days of ranolazine.~Right atrial pressure (RAP) Systolic pulmonary artery pressure (SPAP) Diastolic pulmonary artery pressure (DPAP) Cardiac output (CO) Cardiac index (CI)"|180 days||||percent change||Standard Deviation|Mean
1327976|NCT02133352|Primary|Percent Change in mPAP, PAOP and Pulmonary Vascular Resistance (PVR)|"Assess the percent change in mPAP, PAOP and pulmonary vascular resistance (PVR) by RHC.~Additional RHC completed at optional follow up for patients remaining on ranolazine upon completion of 180 day period."|180 days|We hypothesize that patients with pulmonary hypertension associated with diastolic left ventricular dysfunction treated with Ranolazine (initiated at 500 mg twice daily and increased to 1000mg twice daily) would have improved hemodynamic parameters, functional capacity and exercise tolerance compared to baseline.|||percentage change||Standard Deviation|Mean
1327977|NCT02133235|Primary|Time Required for Proper Placement of the Endobronchial Blocker||10-15 minutes||||seconds||Standard Deviation|Mean
1327978|NCT02133235|Primary|Surgical Grading for Lung Isolation|A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement|10-15 minutes||||participants|||Number
1327979|NCT02133131|Secondary|Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)|The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 16 weeks|Analysis of SVR4 is ongoing and results will be indicated in a future report.||||||
1327980|NCT02133131|Primary|Number of Participants Discontinuing Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population consists of all participants who received ≥1 dose of study drug.|||Number of participants|||Number
1327981|NCT02133131|Primary|Number of Participants Experiencing at Least 1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All Participants as Treated (APaT) population consists of all participants who received ≥1 dose of study drug.|||Number of participants|||Number
1327982|NCT02133131|Primary|Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)|The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 24 weeks|The Per Protocol (PP) population includes all randomized and treated participants who did not have protocol deviations that may substantially affect the results of the primary and secondary endpoints.|||Percentage of participants||95% Confidence Interval|Number
1327983|NCT02133066|Secondary|Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients|If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics.|Participants will be followed until discontinuation of antibiotics, an expected average of 2 days||||hours||95% Confidence Interval|Median
1327984|NCT02133066|Secondary|Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients|If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization.|Participants will be followed for the duration of the hospital stay, an expected average of 2 days||||hours||95% Confidence Interval|Median
1327985|NCT02133066|Secondary|Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group|Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group|30 minutes||||percentage success||95% Confidence Interval|Number
1327986|NCT02133066|Primary|Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group|First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group|30 minutes||||percent success||95% Confidence Interval|Number
1327987|NCT02132949|Secondary|Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause.|Baseline up to death (approximately 6.5 years)|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
1327988|NCT02132949|Secondary|Invasive Disease Free Survival (iDFS) Determined by the Investigator According to RECIST v1.1|iDFS is defined as the time from the first date of no disease (the date of surgery) to the first documentation of progressive invasive disease, relapse, or death. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions.|Baseline until disease progression or death due to any cause up to approximately 6.5 years (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks] and every 3 months thereafter until study completion or early termination)|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
1327989|NCT02132949|Secondary|Event-Free Survival Determined by the Investigator According to RECIST v1.1|EFS is defined as the time from enrollment to the first occurrence of progressive disease, relapse, or death from any cause. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions.|Baseline until disease progression or death due to any cause up to approximately 6.5 years (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks] and every 3 months thereafter until study completion or early termination)|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
1327990|NCT02132949|Secondary|Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period|Clinical response was classified as either complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD: neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. 95% CIs are calculated with the use of the Clopper-Pearson method.|Baseline until disease progression or death due to any cause up to 24 weeks (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks])|ITT population|||percentage of participants||95% Confidence Interval|Number
1327991|NCT02132949|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR) Evaluated at the Time of Surgery Based on Local Pathologist's Assessment After Surgery|tpCR is defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes.|24 weeks after neoadjuvant therapy (Post 8 cycles of neo-adjuvant therapy [cycle length=2¬3 weeks])|ITT population|||percentage of participants||95% Confidence Interval|Number
1327992|NCT02132949|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Pertuzumab||Screening then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 6.5 years)|"ITT population. Here, number of participants analyzed include those who were evaluable for the outcome."|||percentage of participants|||Number
1327993|NCT02132949|Secondary|Percentage of Participants With Drop in LVEF of at Least 10 Points From Baseline and to Below 50% at End of Study|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs will be calculated with the use of the Clopper-Pearson method.|Baseline up to approximately 6.5 years|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
1327994|NCT02132949|Secondary|Percentage of Participants With NYHA Class III and IV Heart Failure at the End of Study|LVSD is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95% CIs will be calculated with the use of the Clopper-Pearson method.|Baseline up to approximately 6.5 years|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
1327995|NCT02132949|Secondary|Percentage of Participants With Drop in LVEF of at Least 10 Points From Baseline and to Below 50% During the Adjuvant Treatment Period at Primary Completion Date (03 March 2016)|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs was calculated with the use of the Clopper-Pearson method.|Cycle 9 to Cycle 21 (cycle length=3 weeks; up to approximately 8 months) up to clinical cut-off date, 03 March 2016 (Month 20)|Safety analysis population who have started adjuvant treatment and were analyzable at the clinical cut-off date (03 March 2016).|||percentage of participants||95% Confidence Interval|Number
1327996|NCT02132949|Secondary|Percentage of Participants With NYHA Class III and IV Heart Failure During the Adjuvant Treatment Period at Primary Completion Date (03 March 2016)|LVSD is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95% CIs was calculated with the use of the Clopper-Pearson method.|Cycle 9 to Cycle 21 (cycle length=3 weeks; up to approximately 8 months) up to clinical cut-off date, 03 March 2016 (Month 20)|Safety analysis population who have started adjuvant treatment and were analyzable at the clinical cut-off date (03 March 2016).|||percentage of participants||95% Confidence Interval|Number
1327997|NCT02132949|Primary|Percentage of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) of at Least 10 Percentage Points From Baseline and to Below 50% During the Neoadjuvant Treatment Period|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs are calculated with the use of the Clopper-Pearson method.|Baseline to 24 weeks|Safety analysis population|||percentage of participants||95% Confidence Interval|Number
1327998|NCT02132949|Primary|Percentage of Participants With New York Heart Association (NYHA) Class III and IV Heart Failure During the Neoadjuvant Treatment Period|Symptomatic left ventricular systolic dysfunction (LVSD) is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95 percent (%) confidence intervals (CIs) are calculated with the use of the Clopper-Pearson method.|Baseline to 24 weeks|Safety analysis population included all participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1327999|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4; Baseline to Week 8||||units on a scale||95% Confidence Interval|Mean
1328000|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4||||units on a scale||95% Confidence Interval|Mean
1328001|NCT02132936|Secondary|Time to ‘Treatment Success’ According to PGA.|"Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.~‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline."|From Baseline to Week 12||||weeks||Inter-Quartile Range|Median
1328002|NCT02132936|Secondary|Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.|Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.|Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel||||percentage of subjects|||Number
1328003|NCT02132936|Primary|Treatment Success According to the PGA|"To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.~Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician’s Global Assessment of Disease Severity (PGA).~‘Treatment success’ was defined as achieving ‘clear’ or ‘almost clear’ for subjects with at least ‘moderate’ disease at baseline and ‘clear’ for subjects with ‘mild’ disease at baseline."|4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel||||percentage of subjects|||Number
1328004|NCT02132884|Other Pre-specified|Progression Free Survival (Arm A)|The progression free survival of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.|Time from start of second line treatment to time of progression or death, whichever occurs first, assessed up to 2 year|||||||
1328005|NCT02132884|Other Pre-specified|Response Rate Defined by RECIST 1.1 (Arm A)|The response rate of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.|Up to 2 years|||||||
1328006|NCT02132884|Other Pre-specified|Incidence of Non-protocol Testing (Arm A)|The incidence of non-protocol testing of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.|Up to 2 years|||||||
1328007|NCT02132884|Other Pre-specified|Concordance of Variants (Arm B)|The concordance of variants identified when sequencing will be performed on samples from the same patient collected at baseline and follow-up time points will also be measured.|Up to 2 years|||||||
1328008|NCT02132884|Secondary|Proportion of Arm B Patients Whose Second Line Therapy is Changed as a Result of Physician Access to CancerCode-50 Results|To assess the effect of sequencing on clinical practice and decision making the proportion of Arm B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results will be computed. This comparison will be based on information provided by the treating physician before being exposed to the sequencing results, and information obtained from a from post-treatment chart review.|Up to 2 years|||||||
1328009|NCT02132884|Secondary|Response Rate Defined by RECIST 1.1|The response rate (with 95% two-sided confidence intervals) will be computed separately by arm. One-sided chi-square or Fisher’s exact tests (alpha = .1) will be used to evaluate differences in response rates between arms.|Up to 2 years|||||||
1328010|NCT02132884|Primary|Progression Free Survival|A chi-square test (one-sided; alpha = .1) will be used to assess the efficacy of treating patients with targeted agents based in the Cancer-Code-50 in the second line setting. For each patient “success” will be defined as being progression free for at least 3 months following initiation of second line therapy. Progression free survival times will be characterized separately by arm using the method of Kaplan and Meier.|Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months|||||||
1328011|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale – Current (VASS-C), current stress level is ranked on a 0 – 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question “Please rate your current stress level."|week 3||||units on a scale||Standard Deviation|Mean
1328012|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale – Current (VASS-C), current stress level is ranked on a 0 – 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question “Please rate your current stress level."|week 2||||units on a scale||Standard Deviation|Mean
1328031|NCT02132767|Secondary|Time to Conversion to Sustained, Stable Non-AF Rhythm||Up to index hospital discharge or 7 days post surgery, whichever came first|All randomized patients (intent to treat)|||days||Inter-Quartile Range|Median
1328013|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale – Current (VASS-C), current stress level is ranked on a 0 – 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question “Please rate your current stress level."|week 1||||units on a scale||Standard Deviation|Mean
1328014|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:~20-44 Normal Range~45-59 Mild to Moderate Anxiety Levels~60-74 Marked to Severe Anxiety Levels~75-80 Extreme Anxiety Levels"|week 3||||units on a scale||Standard Deviation|Mean
1328015|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:~20-44 Normal Range~45-59 Mild to Moderate Anxiety Levels~60-74 Marked to Severe Anxiety Levels~75-80 Extreme Anxiety Levels"|week 2||||units on a scale||Standard Deviation|Mean
1328016|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:~20-44 Normal Range~45-59 Mild to Moderate Anxiety Levels~60-74 Marked to Severe Anxiety Levels~75-80 Extreme Anxiety Levels"|week 1||||units on a scale||Standard Deviation|Mean
1328017|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 3||||units on a scale||Standard Deviation|Mean
1328018|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 2||||units on a scale||Standard Deviation|Mean
1328019|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 1||||units on a scale||Standard Deviation|Mean
1328020|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 3||||ratio of errors (see OM description)||Standard Deviation|Mean
1328021|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 2||||ratio of errors (see OM description)||Standard Deviation|Mean
1328022|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 1||||ratio of errors (see OM description)||Standard Deviation|Mean
1328023|NCT02132767|Secondary|Cost (Hospital)|Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups|Within 60 days of randomization|||||||
1328024|NCT02132767|Secondary|AF- or Treatment-related Events||Within 60 days of randomization|||||||
1328025|NCT02132767|Secondary|Outpatient Interventions|Compare frequency of outpatient visits between groups for any cause and AF-related causes|Within 60 days of randomization||||hospital stays < 24 hours|||Number
1328026|NCT02132767|Secondary|Length of Stay (Rehospitalization, Including ED Visits)|Compare frequency of readmissions between groups for any cause and AF-related hospitalizations|Within 60 days of randomization||||days||Inter-Quartile Range|Median
1328027|NCT02132767|Secondary|Length of Stay (Index Hospitalization)|Overall length of stay for the index hospitalization|Within 60 days post surgery||||days||Inter-Quartile Range|Median
1328028|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization|60 days after randomization||||participants|||Number
1328029|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization|30 days after randomization||||participants|||Number
1328030|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge|Hospital discharge||||participants|||Number
1328032|NCT02132767|Primary|Total Number of Days in Hospital|The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.|Within 60 days of randomization|All randomized patients (intent to treat)|||days||Inter-Quartile Range|Median
1328033|NCT02132637|Secondary|Beta Cell Function|Beta cell function assessed by the change between pre meal tolerance test and 30 minutes post meal tolerance test in C-peptide corrected insulin/Glucose (ΔC-peptide corrected insulin/ΔGlucose). LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|0-30 minutes during the meal tolerance test on the day following the standard dose|All randomized participants who received at least one dose of study drug and had evaluable ΔC-peptide data were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
1328034|NCT02132637|Secondary|Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion|Glucose AUC excursion within 3 hours after each meal assessed by the AUC of adjusted glucose (= observed glucose – preprandial glucose) from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Preprandial to 3 Hours Postprandial during the day following the standard dose|All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis.|||mg/dL*h||Standard Error|Least Squares Mean
1328035|NCT02132637|Secondary|Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)|Glucose AUC within 3 hours after each meal assessed by the AUC of glucose from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Preprandial to 3 Hours Postprandial during the day following the standard dose|All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis.|||mg/dL*h||Standard Error|Least Squares Mean
1328036|NCT02132637|Secondary|Fasting Blood Glucose|Fasting blood glucose (FBG) was measured by self-monitored blood glucose. LS means were calculated by MMRM analysis with fixed effects of treatment, dosing day, sequence, period, interaction of treatment and dosing day, baseline basal insulin dose stratification factor, and baseline FBG.|Day 1, Day 2, and Day 3 Following Double Dose|All randomized participants who received the double dose of study drug and had evaluable fasting blood glucose data were included in the analysis.|||mg/dL||Standard Error|Least Squares Mean
1328037|NCT02132637|Secondary|Duration of Glucose ≤70 mg/dL|The duration in minutes of each hypoglycemia episode with glucose ≤70 mg/dL (3.9 mmol/L) was calculated from start time to end time. The duration for a participant was the sum of the durations over the multiple hypoglycemia episodes. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||Minutes per participant||Standard Error|Least Squares Mean
1328038|NCT02132637|Secondary|Time to the Nadir Glucose|Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). The average time was calculated by dividing the sum of time from double dose to the nadir glucose for participants with blood glucose ≤70 mg/dL (3.9 mmol/L) by the number of participants with blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis.|||hours||Standard Deviation|Mean
1328039|NCT02132637|Secondary|Nadir Glucose|Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis.|||mg/dL||Standard Error|Least Squares Mean
1328040|NCT02132637|Secondary|Percentage of Participants With Hypoglycemia|The percentage was calculated by dividing the number of participants with hypoglycemia events defined as blood glucose ≤70 mg/dL (3.9 mmol/L) by the total number of participants analyzed, multiplied by 100.|Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||percentage of participants|||Number
1328041|NCT02132637|Secondary|Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose|The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100.|Predose to 12 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||percentage of participants|||Number
1328042|NCT02132637|Primary|Percentage of Participants With Clinically Significant Hypoglycemia|The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 milligrams per deciliter (mg/dL) (3.0 millimole per liter [mmol/L]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||percentage of participants|||Number
1328043|NCT02132611|Secondary|Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours||||percentage of procedures||95% Confidence Interval|Number
1328238|NCT02130284|Primary|Severe Hypoglycemia|Evaluation of incidence of severe hypoglycemia during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
1328044|NCT02132611|Primary|Major Adverse Cardiac Event (MACE)|"A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.~30-Day MACE is composed of:~Cardiac death~Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave~Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure"|30 Days||||Percent Probability of Freedom from MACE||95% Confidence Interval|Number
1328045|NCT02132572|Primary|Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant|Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.|3 to 10 years|Per Protocol: Subjects who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants 3 to 10 years prior to data collection|||Percentage of Subjects|||Number
1328046|NCT02132468|Secondary|Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1|The objective response rate (complete response, partial response, progressive disease, or stable disease) was determined by the investigator assessment of the participant's CT or MRI using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) for target lesions. Partial Response (PR) is when there is at least 30% decrease in sum of the longest diameter of the target lesions. Progressive Disease (PD) is when there is at least 20% increase in the sum of the longest diameter of the target lesions, as well as an absolute increase of at least 5 mm (including appearance of new lesions). Stable Disease (SD) is when there neither a PR nor PD is noted.|Baseline and 4 months|Modified Intent-to-Treat|||Participants|||Count of Participants
1328047|NCT02132468|Primary|Number of Participants With Improved, Stable, or Worsened Change In Serotonin Biomarker Levels From Baseline|The mean change from baseline in serotonin biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.|Baseline and 4 months|Participants who had serotonin biomaker samples taken at baseline and at 4 months.|||Participants|||Count of Participants
1328048|NCT02132468|Primary|Number of Participants With Improved, Stable, or Worsened Change In 5-hydroxyindoleacetic Acid (5-HIAA) Biomarker Levels From Baseline|The mean change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.|Baseline and 4 months|Participants who had 5-hydroxyindoleacetic acid (5-HIAA) biomaker sample taken at baseline and at 4 months.|||Participants|||Count of Participants
1328049|NCT02132468|Primary|Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline|The mean change from baseline in chromogranin A (CgA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.|Baseline and 4 months|Safety Population|||Participants|||Count of Participants
1328050|NCT02132247|Secondary|Plasma Concentration of Diclofenac||Day 2 and either Day 4, 7 or 14, depending upon pain resolution|One participant missed a blood draw.|||ng/mL||Standard Deviation|Mean
1328051|NCT02132247|Secondary|Patient Assessment of Pain on a 6-point Scale|"Wong-Baker FACES Scale 6-point scale:~No Hurt - 0; Hurts Little Bit - 1; Hurts Little More - 2; Hurts Even More - 3; Hurts Whole Lot - 4; Hurts Worst - 5."|Up to 2 weeks, depending upon pain resolution||||units on a scale||Standard Deviation|Mean
1328052|NCT02132247|Secondary|Investigator Assessment of the Global Response to Therapy on a 5-point Scale|5-point scale: No clinical improvement in pain intensity and/or functional performance - 1; Slight clinical improvement in pain intensity and/or functional performance - 2; Moderate clinical improvement in pain intensity and/or functional performance - 3; Marked clinical improvement in pain intensity and/or functional performance - 4; Restoration of normal functional performance in the absence of any pain - 5.|Up to 2 weeks, depending upon pain resolution||||Participants|||Count of Participants
1328053|NCT02132247|Primary|Dermatologic Assessment at the Patch Application Site|None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6.|Up to 2 weeks, depending upon pain resolution||||Units on a scale||Standard Deviation|Mean
1328054|NCT02132169|Secondary|Safety of AC 170 0.024% Compared to Its Vehicle|Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients).|Up to 12 Weeks|Intent to Treat (ITT)|||adverse events|||Number
1328055|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1328056|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1328057|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1328058|NCT02132117|Secondary|Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement.|Baseline, Day 1 (Hour 1)|ITT Population included all randomized participants.|||percentage of participants|||Number
1328375|NCT02127892|Secondary|Number of Participants With Donor-derived CD3+ T Lymphocytes >/= 100/mm3|Absolute number of donor-derived CD3+ T lymphocytes >/= 100/mm3 in participating subjects.|1 year||||Participants|||Count of Participants
1328059|NCT02132117|Secondary|Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29|Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: “Right now, how much does your face burn because of your facial redness?” using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants, with data available for analysis at the given time-point. Only participants who had a SA-RFR score of 1-4 at Baseline are included in the Analysis.|||score on a scale||Standard Deviation|Mean
1328060|NCT02132117|Secondary|Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29|Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: “Right now, how satisfied are you with the effect your study medication had on your facial redness?” using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported.|Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants with data available for analysis.|||percentage of participants|||Number
1328061|NCT02132117|Secondary|Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29|DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.|||percent change in area of redness||Full Range|Median
1328062|NCT02132117|Secondary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.|||percentage of participants|||Number
1328063|NCT02132117|Primary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales|The investigator assessed the participant’s overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Intent-to-treat (ITT) Population included all randomized participants.|||percentage of participants|||Number
1328064|NCT02131662|Other Pre-specified|Estimated Dose-response Curve Based on Amenorrhea - δ|The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. δ is hill slope parameter which measures sensitivity of the response to the dose range of the drug, determining the steepness of the dose-response curve.|After end of the initial bleeding episode until the end of treatment||||Slope|||Number
1328065|NCT02131662|Other Pre-specified|Estimated Dose-response Curve Based on Amenorrhea - ED50|The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. ED50 is the dose at which 50% of Emax were achieved.|After end of the initial bleeding episode until the end of treatment||||mg|||Number
1328066|NCT02131662|Other Pre-specified|Estimated Dose-response Curve Based on Amenorrhea - E0 and Emax|The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. E0 is the amenorrhea rate for placebo; Emax is the maximum effect attributable to the drug (compared with the basal effect with dose at d=0 [placebo group], the maximum increase of drug effect).|After end of the initial bleeding episode until the end of treatment||||Percentage|||Number
1328067|NCT02131662|Other Pre-specified|Percentage of Subjects With HMB Response During the Last 28 Days of Treatment||Last 28 Days of Treatment||||Percentage of subjects|||Number
1328068|NCT02131662|Other Pre-specified|Percentage of Subjects With Amenorrhea (Defined as MBL < 2 mL) During the Last 28 Days of Treatment||Last 28 Days of Treatment||||Percentage of subjects|||Number
1328079|NCT02131636|Secondary|Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9|The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as “very satisfied” or “satisfied” are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29.|Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1328100|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling||||LogMAR||Standard Deviation|Mean
1328069|NCT02131662|Other Pre-specified|Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)|The ability of the MP to identify subjects with HMB (defined as > 80 mL of blood loss during bleeding episode) per 28 days against the the current gold standard (i.e. AH method) was assessed. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MP method for detecting heavy menstrual bleeding were calculated against AH method. Sensitivity = true positive/(true positive + false negative)*100; Specificity = true negative/(true negative + false positive)*100; PPV = true positive/(true positive + false positive)*100; NPV = true negative/(true negative + false negative)*100. MP version 2014 was originally defined based on studies in healthy subjects. And MP version 2016 was developed for study population of women with heavy bleeding.|At baseline|An analysis set for the assessment of the interchangeability of the MP and the AH method to judge MBL included all screened subjects (except subjects in Japan) with any sanitary product data for which there is any matching pair of MP score and AH value available. A total of 399 subjects were included in this analysis set.|||Percentage|||Number
1328070|NCT02131662|Other Pre-specified|Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea|The final exposure-response model was used to simulate the percentage of subjects below 90% of the maximum probability of induced amenorrhea (that is, all days with bleeding intensity 1 = none) for the selected doses 1, 2 and 3 mg (see table below).|From start of the study treatment to Day 84 (treatment period)||||Percentage of subjects|||Number
1328071|NCT02131662|Other Pre-specified|Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan|Area-under-the-curve (AUC) of vilaprisan between 0 and 24 hours post-dose at steady-state achieving 50% of maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with induced-amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.|From start of the study treatment to Day 84 (treatment period)|The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267).|||mcg*h/L||95% Confidence Interval|Number
1328072|NCT02131662|Other Pre-specified|Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea|Maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.|From start of the study treatment to Day 84 (treatment period)|The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267).|||Percentage of subjects||95% Confidence Interval|Number
1328073|NCT02131662|Secondary|Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI|Pelvic Magnetic resonance imagings (MRI), without contrast agents, were performed for volume measurements of the uterus and fibroids preferably using 1.5 Tesla scanners or higher. Images were sent to the imaging core laboratory for evaluation. Volume measurements of the uterus and fibroids were performed centrally by independent radiologist(s).|From baseline to end of follow-up period||||mL||Full Range|Median
1328074|NCT02131662|Secondary|Time to Onset of Controlled Bleeding|Onset of controlled bleeding was defined by the first day, for which the MBL (assessed by MP, Version 2014) for all subsequent 28-day periods up to the end of the treatment period was less than 80 mL. Kaplan-Meier estimated time to onset of controlled bleeding (days) was reported.|During treatment period||||Days||Inter-Quartile Range|Median
1328075|NCT02131662|Secondary|Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)|"In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively."|From baseline to end of follow-up||||mL||Standard Deviation|Mean
1328076|NCT02131662|Primary|Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment|Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.|After end of the initial bleeding episode until the end of treatment, up to 12 weeks||||Percentage of subjects|||Number
1328077|NCT02131636|Secondary|Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 1 (Hour 1)|Intent-to-Treat: all randomized patients|||Percentage of Pateints|||Number
1328078|NCT02131636|Secondary|Change From Baseline on the SA-RFR Questionnaire Item #4|The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1328121|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D|Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|Baseline||||percentage of subjects|||Number
1328080|NCT02131636|Secondary|Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)|Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients with data at the time point|||Percent Change||Standard Deviation|Mean
1328081|NCT02131636|Secondary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1328082|NCT02131636|Primary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales|The investigator assessed the patient’s overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1328083|NCT02131532|Primary|Feasibility of Follow-up Assessment at Three Months After the End of Treatment|Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.|3 months after the end of treatment||||participants|||Number
1328084|NCT02131532|Primary|Feasibility of Telephone-delivered Booster Sessions|Numbers of participants who attended the booster session as planned and those who rearranged the session|3 months after the end of treatment||||participants|||Number
1328085|NCT02131532|Primary|Attendance of Treatment Sessions|Number of participants who completed all treatment sessions.|3 months after the end of treatment||||participants|||Number
1328086|NCT02131532|Primary|Feasibility of Recruitment Process|The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.|3 months after the end of treatment||||participants|||Number
1328087|NCT02131532|Secondary|SIS - Social Activity|The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328088|NCT02131532|Secondary|SIS - Hand Function|The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328089|NCT02131532|Secondary|SIS - Mobility|The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328090|NCT02131532|Secondary|SIS - Daily Activities|The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328091|NCT02131532|Secondary|SIS - Communication|The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328092|NCT02131532|Secondary|SIS - Emotion|The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328093|NCT02131532|Secondary|SIS - Memory and Thinking|The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328094|NCT02131532|Secondary|SIS - Physical Strength|The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328095|NCT02131532|Secondary|Stroke Impact Scale (SIS) - General Rating of Recovery|The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328096|NCT02131532|Secondary|Nottingham Extended Activities of Daily Living (NEADL)|The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328097|NCT02131532|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328098|NCT02131532|Secondary|Fatigue Assessment Scale (FAS)|"This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study).~The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity."|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
1328099|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling||||LogMAR||Standard Deviation|Mean
1328179|NCT02131064|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death from any cause.|From randomization until death (up to approximately 45 months)||2019-01-31|01/2019||||
1328101|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling||||LogMAR||Standard Deviation|Mean
1328102|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328103|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328104|NCT02131402|Primary|Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328105|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A|Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).|Baseline||||units on a scale||Standard Deviation|Mean
1328106|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D|Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)|Baseline||||units on a scale||Standard Deviation|Mean
1328107|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).|Baseline||||units on a scale||Standard Deviation|Mean
1328108|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|1 hour post settling||||percentage of eyes|Eyes||Number
1328109|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|1 hour post settling||||percentage of eyes|Eyes||Number
1328110|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).|1 hour post settling||||percentage of eyes|Eyes||Number
1328111|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328112|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328113|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328114|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328115|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328116|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328117|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|1 hour post settling||||percentage of subjects|||Number
1328118|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|1 hour post settling||||percentage of subjects|||Number
1328119|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A|Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|1 hour post settling||||percentage of subjects|||Number
1328120|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A|Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|Baseline||||percentage of eyes|||Number
1334066|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted.|6 months|PFT's not done on children under age of 5.|||Percent predicted||Standard Deviation|Mean
1328122|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|Baseline||||percentage of subjects|||Number
1328123|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).|1 hours post settling||||units on a scale||Standard Deviation|Mean
1328124|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328125|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A|Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328126|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A|Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).|Baseline||||units on a scale||Standard Deviation|Mean
1328127|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).|Baseline||||units on a scale||Standard Deviation|Mean
1328128|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D|Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).|Baseline||||units on a scale||Standard Deviation|Mean
1328129|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328130|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D|Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328131|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).|1 hour post settling||||units on a scale||Standard Deviation|Mean
1328132|NCT02131324|Primary|The Percentage of Subjects With HPA Axis Suppression.|HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)|Day 15|All summaries and analyses were performed on the safety population. All subjects who received at least one confirmed dose of study product and provided any post-baseline safety information were included in the safety population. No imputation was made for missing safety data.|||percentage of participants|||Number
1328133|NCT02131311|Secondary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||percentage of subjects|||Number
1328134|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of a 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||grams/usage period||Inter-Quartile Range|Median
1328135|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||number of episodes/usage period||Inter-Quartile Range|Median
1328136|NCT02131311|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = ‘Not at all,’ 1= ‘Slightly,’ 2 = ‘Moderately,’ or 3 ‘Greatly.’ The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at end of treatment"|||units on a scale||Inter-Quartile Range|Median
1328137|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||grams/usage period||Inter-Quartile Range|Median
1328138|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||episodes/usage period||Inter-Quartile Range|Median
1328139|NCT02131311|Primary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||percentage of subjects|||Number
1334067|NCT02029521|Secondary|Forced Vital Capacity|Percent predicted of forced vital capacity.|6 months|PFT's not done on children under age of 5.|||Percent Predicted||Standard Deviation|Mean
1328140|NCT02131272|Secondary|Incidence of Adverse Events (AEs)|The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment.|weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.|||Number of events|||Number
1328141|NCT02131272|Secondary|Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.|Weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.|||Number of episodes|||Number
1328142|NCT02131272|Secondary|Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.|Weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.|||Number of episodes|||Number
1328143|NCT02131272|Secondary|Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment|Proportion of subjects achieving HbA1c below 7.5% is presented as percentage of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.|At week 26|Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).|||Percentage of subjects|||Number
1328144|NCT02131272|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.|Proportion of subjects achieving HbA1c <7.0% is presented as percentage of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.|At week 26|Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).|||Percentage of subjects|||Number
1328145|NCT02131272|Secondary|Change in Body Weight Standard Deviation Score (SDS)|Change in body weight standard deviation score (SDS) from baseline to week 26. In order to reduce the variability in body weight measurements, SDS were calculated. SDS for weight was derived by comparing the actual measurements with standard growth charts for the United States. Standard values provided by the standard growth charts according to the subject’s sex and age at the time of the measurement were used to calculate the SDS.|week 0, week 26|Full analysis set included all the randomised subjects.|||standard deviation score||Standard Deviation|Mean
1328146|NCT02131272|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.|week 0, week 26|Full analysis set included all the randomised subjects.|||Percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1328147|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE|Up to Week 96|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328148|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328149|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328209|NCT02130635|Secondary|Part A: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15|Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.|Day 7 and Day 15|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
1328150|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE at Week 48|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328151|NCT02131233|Secondary|Percentage of Participants With a SAE After 96 Weeks of Treatment|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328152|NCT02131233|Secondary|Percentage of Participants With a Serious Adverse Event (SAE) at Week 48|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328153|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328154|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328155|NCT02131233|Secondary|Percentage of Participants With an AE After 96 Weeks of Treatment|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328156|NCT02131233|Secondary|Percentage of Participants With an Adverse Event (AE) at Week 48|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1328157|NCT02131233|Secondary|Change From Baseline in CD4 Cell Count at Week 96|CD4 cells were counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values.|Baseline and Week 96|All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.|||cells/mm^3||95% Confidence Interval|Mean
1328158|NCT02131233|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values.|Baseline and Week 48|All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.|||cells/mm^3||95% Confidence Interval|Mean
1328207|NCT02130635|Secondary|Part B: Number of Times Rescue Medication Was Used by Participants Daily, During the Treatment Period|Rescue medication was identified from concomitant medication records and the patient diaries which were provided to the participants to record data throughout the treatment period. Only participants who used rescue medication were analyzed. The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.|Day 1 to Day 15|Safety Population|||Number of times||Standard Deviation|Mean
1328159|NCT02131233|Secondary|Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96|From blood samples collected at week 96, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA “snapshot” approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.|Week 96|All randomized participants who received at least one dose of study treatment|||Percentage of participants|||Number
1328160|NCT02131233|Primary|Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48|From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA “snapshot” approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.|Week 48|All randomized participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
1328161|NCT02131064|Secondary|Percentage of Participants With ATA to Trastuzumab||Baseline (Pre-trastuzumab [0 hr] infusion [infusion duration = 90 min] on Day 1 of Cycle 1); post-baseline (Pre-trastuzumab infusion [0 hr] on Day 1 of Cycle 6) (each cycle = 21 days) in neoadjuvant and adjuvant period||2019-01-31|01/2019||||
1328162|NCT02131064|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TDM-1|Participants were considered post-baseline ATA positive if they had ATAs post-baseline that were either treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a negative or missing ATA result at baseline, and at least one positive ATA result post-baseline. Participants had treatment-enhanced ATAs if they had a positive ATA result at baseline, and at least one positive ATA result post-baseline that was greater than or equal to (>/=) 0.60 titer units higher than the result at baseline.|Baseline (Pre-TDM1 [0 hr] infusion [infusion duration = 90 min] on Day 1 of Cycle 1); post-baseline (Pre-TDM1 infusion [0 hr] on Day 1 of Cycle 6) (each cycle = 21 days) in neoadjuvant period|ITT population, including participants from T-DM1 + P arm only. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category.|||percentage of participants|||Number
1328163|NCT02131064|Secondary|Serum Levels of Plasma DM1-Containing Catabolites Concentrations (in ng/mL) (Nonreducible Thioether Linker [MCC]-DM1 and Lysine [Lys]-MCC-DM1)||Pre-study treatment infusion (0 hr) (infusion duration = 90 min) on Day 1 of Cycle 1 (cycle length = 21 days) in neoadjuvant period; 15-30 min post-study treatment infusion on Day 1 of Cycle 1 and 6 in neoadjuvant and adjuvant period||2019-01-31|01/2019||||
1328164|NCT02131064|Secondary|Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) Concentrations|DM1 is the metabolite of trastuzumab emtansine. Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|Pre-study treatment infusion (0 hr) (infusion duration = 90 min) on Day 1 of Cycle 1 (cycle length = 21 days); 15-30 min post-study treatment infusion on Day 1 of Cycle 1 and 6 in neoadjuvant period|PK population. Overall number of participants analyzed = Participants in PK Population evaluable for this outcome measure. Number Analyzed = participants evaluable for specified category.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1328165|NCT02131064|Secondary|Cmin of Trastuzumab Emtansine and Total Trastuzumab|Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|Pre-study treatment infusion (0 hr) (infusion duration = 90 min) on Day 1 of Cycle 6 (cycle length = 21 days) in neoadjuvant period|PK population. Overall number of participants analyzed = Participants in PK Population evaluable for this outcome measure. Number Analyzed = participants evaluable for specified category.|||mcg/mL||Standard Deviation|Mean
1328166|NCT02131064|Secondary|Minimum Observed Serum Concentration (Cmin) of Trastuzumab|Only participants who received trastuzumab were to be analyzed for this outcome.|Pre-study treatment infusion (0 hours [hr]) (infusion duration = 90 min) on Day 1 of Cycle 6 (cycle length = 21 days) in neoadjuvant period|PK population. Overall number of participants analyzed = Number of participants in PK Population with evaluable samples at a given timepoint.|||mcg/mL||Standard Deviation|Mean
1328167|NCT02131064|Secondary|Cmax of Trastuzumab Emtansine and Total Trastuzumab|Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|15-30 min post-study treatment infusion (infusion duration = 90 min) on Day 1 of Cycle 1 and 6 (each cycle = 21 days) in neoadjuvant period|PK population. Overall number of participants analyzed = Participants in PK Population evaluable for this outcome measure. Number Analyzed = participants evaluable for specified category.|||mcg/mL||Standard Deviation|Mean
1328168|NCT02131064|Secondary|Maximum Observed Serum Concentration (Cmax) of Trastuzumab|Only participants who received trastuzumab were to be analyzed for this outcome.|15-30 minutes (min) post-study treatment infusion (infusion duration = 90 min) on Day 1 of Cycle 1 and 6 (each cycle = 21 days) in neoadjuvant period|Pharmacokinetic (PK) population:all participants who received at least one dose of T-DM1 (in T-DM1 + P arm) or TCH (in TCH + P arm), and had at least one post-treatment serum sample. Overall number of participants analyzed=Participants in PK Population evaluable for this outcome. Number Analyzed=participants evaluable for specified category.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1328169|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Increase in Symptom Subscales|Participants rated their symptoms on EORTC QLQ C-30 and mQLQ-BR23, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates greater degree of symptoms. Clinically meaningful increase in symptoms was defined as an increase in score (deterioration) of 11 points in nausea and vomiting, pain, dyspnea; increase of 9 points in insomnia; increase of 14 points in appetite loss; increase of 15 points in diarrhea, constipation; increase of 10 points in fatigue, systemic therapy side effects, hair loss.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category.|||percentage of participants|||Number
1328208|NCT02130635|Secondary|Part B: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15|Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.|Day 7 and Day 15|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
1328170|NCT02131064|Secondary|Time to Clinically Meaningful Deterioration in Function Subscale|Participants rated their function on EORTC QLQ C-30, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better functioning. Time to deterioration was defined as the time from baseline to first 10-point (or greater) decrease as measured by physical function; to first 14-point (or greater) decrease as measured by role function, to first 7-point (or greater) decrease as measured by cognitive function. Median time to deterioration was estimated with Kaplan-Meier method. The 95% CI for the median was computed using the method of Brookmeyer and Crowley.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1328171|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Deterioration in Function Subscales|Participants rated their function on EORTC QLQ C-30, with total score and single-item (physical, cognitive and role functioning) scores ranging from 0 (worst) to 100 (best); where higher score indicates better functioning. Clinically meaningful deterioration was defined as a decrease in score of 10 points in physical function; decrease of 7 points in cognitive function and decrease of 14 points in role function.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1328172|NCT02131064|Secondary|Time to Clinically Meaningful Deterioration in GHS/QoL Score|Participants rated their quality of life (global health status) on EORTC QLQ C-30, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better quality of life. Time to deterioration was defined as the time from baseline to first 10-point (or greater) decrease as measured by GHS/QoL. All valid GHS/QoL questionnaires of the neoadjuvant phase including surgery were used. Participants without deterioration were censored at the time of completing the last GHS/QoL plus 1 day. Median time to deterioration was estimated with Kaplan-Meier method. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1328173|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Score|Participants rated their quality of life (global health status) on European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ- C30), with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better quality of life. Clinically meaningful deterioration in GHS/QoL was defined as a decrease in score of 10 points in GHS/QoL.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = Number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1328174|NCT02131064|Secondary|Percentage of Participants by Response for Hair Loss Single Item|Participants answered the Question “Have you lost any hair?”, from the mQLQ-BR23, on a 5-point scale (1 ‘Not at all’, 2 ‘A little’, 3 'Somewhat', 4 ‘Quite a bit’, 5 ‘Very much’). Percentage of participants by each response was reported.|Baseline, Cycle 3, Cycle 5 of neoadjuvant period (each cycle = 21 days); pre-surgery visit (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category. Percentage values are based on ITT N.|||percentage of participants|||Number
1328175|NCT02131064|Secondary|Percentage of Participants by Response for Skin Problem Single Items|Participants answered the Question 1 “Did itching skin bother you?” and Question 2 “Have you had skin problems?”, from the mQLQ-BR23, on a 5-point scale (1 ‘Not at all’, 2 ‘A little’, 3 'Somewhat', 4 ‘Quite a bit’, 5 ‘Very much’). Percentage of participants by each response was reported.|Baseline, Cycle 3, Cycle 5 of neoadjuvant period (each cycle = 21 days); pre-surgery visit (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category. Percentage values are based on ITT N.|||percentage of participants|||Number
1328176|NCT02131064|Secondary|Percentage of Participants by Response for Neuropathy Single Item|Participants answered the question “Did you have tingling hands/feet?”, from the Modified Quality of Life Questionnaire Breast Cancer 23 (mQLQ-BR23), on a 5-point scale (1 ‘Not at all’, 2 ‘A little’, 3 'Somewhat', 4 ‘Quite a bit’, 5 ‘Very much’). Percentage of participants by each response was reported.|Baseline, Cycle 3, Cycle 5 of neoadjuvant period (each cycle = 21 days); pre-surgery visit (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment. Overall number of participants analyzed = participants evaluable for this outcome measure. Number Analyzed = participants evaluable for the specified category. Percentage values are based on ITT N.|||percentage of participants|||Number
1328177|NCT02131064|Secondary|Percentage of Participants With Selected Adverse Events (AEs)|Selected AEs included hepatotoxicity, pulmonary toxicity, cardiac dysfunction, neutropenia, thrombocytopenia, peripheral neuropathy, hemorrhage, infusion related reaction (IRR)/hypersensitivity, IRR/Hypersensitivity symptoms, rash, diarrhea and mucositis. An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|Neoadjuvant phase (Baseline up to Cycle 6, each cycle = 21 days)|Safety Population comprised all participants who received at least one full or partial dose of any study treatment. Participants were analyzed according to the treatment they actually received.|||percentage of participants|||Number
1328178|NCT02131064|Secondary|Percentage of Participants Who Received Breast-Conserving Surgery (BCS)|BCS rate was defined as the percentage of participants who achieve BCS out of the ITT population of participants without inflammatory breast cancer.|6 months|A subset of ITT population including participants who had non-inflammatory breast cancer at baseline. Participants were analyzed according to their randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1328180|NCT02131064|Secondary|Invasive Disease-free Survival (IDFS)|IDFS is defined only for participants who undergo surgery. Participants who do not undergo surgery will be excluded from the analysis. IDFS is defined as the time from surgery to the first documented occurrence of an IDFS event, defined as: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast as the original primary lesion); Ipsilateral local−regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Distant recurrence (i.e., evidence of breast cancer, excluding ipsilateral invasive or local-regional breast cancer, in any anatomic site that has been either histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); Contralateral invasive breast cancer; and death from any cause.|From surgery to the first documented occurrence of IDFC event (up to approximately 45 months)||2019-01-31|01/2019||||
1328181|NCT02131064|Secondary|Event-free Survival (EFS) Assessed by Investigator Based on Radiological, Clinical and Histological Assessment|EFS is defined as the time from randomization to disease progression or disease recurrence (local, regional, distant, or contralateral, invasive or non-invasive), or death from any cause.|From randomization up to disease progression or recurrence or death (up to approximately 45 months)||2019-01-31|01/2019||||
1328182|NCT02131064|Primary|Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples|tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.|Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|ITT population. Participants were analyzed according to their randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1328183|NCT02130999|Other Pre-specified|Number of Participants That Reported Suicidal Ideation, Suicidal Behavior, or Suicide Attempts.|Number of Participants that reported suicidal ideation, suicidal behavior, or suicide attempts per treatment arm and overall.|Baseline to End of Study Day 5 (± 2 days).||||participants|||Number
1328184|NCT02130999|Secondary|Number of Participants With Adverse Events|Number of participants with treatment-emergent adverse event per treatment arm and overall.|From Baseline to End of Study; Day 5 (± 2 days).||||participants|||Number
1328185|NCT02130999|Secondary|Metabolite-to-parent AUC(Inf) Ratios After Oral Administration of a Single 20 mg Dose and IV Administration of a Single 2 mg Dose of Tasimelteon|Comparison of the metabolite-to-parent AUC(inf) ratios for the oral and IV routes.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||metabolite to parent AUC (inf) ratios||Standard Deviation|Mean
1328186|NCT02130999|Secondary|AUC(Inf) of Tasimelteon’s Metabolites After a Single Oral and I.V. Dose|The mean +/- SD for the AUC(inf) of tasimelteon’s metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|Only 11 subjects could be analyzed for M11.|||h*ng/mL||Standard Deviation|Mean
1328187|NCT02130999|Secondary|Cmax of Tasimelteon's Metabolites After an Oral and I.V. Dose of Tasimelteon|The mean +/- SD for the Cmax of tasimelteon’s metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||ng/mL||Standard Deviation|Mean
1328188|NCT02130999|Secondary|Total Clearance of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|CL of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||(mL/min)||Standard Deviation|Mean
1328189|NCT02130999|Secondary|T1/2 of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|T1/2 of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours pos-dose||||hour||Standard Deviation|Mean
1328190|NCT02130999|Secondary|AUC (Inf) of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|AUC (inf) of Tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||(h*ng/mL)||Standard Deviation|Mean
1328191|NCT02130999|Secondary|Cmax of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|Cmax of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||ng/mL||Standard Deviation|Mean
1328192|NCT02130999|Primary|Absolute Bioavailability After a Single Oral Dose of Hetlioz™(Tasimelteon) 20mg|The absolute bioavailability (F) of tasimelteon will be estimated from the dose-corrected AUC(inf) after oral and I.V. administration using an analysis of variance (ANOVA) model with treatment, period, sequence, and subject within sequence as the classification variables, using natural log-transformed data. The geometric mean ratio (GMR), oral-to-I.V., and its associated 90% confidence interval (CI) will be used as the estimate of F and its variability.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||Geometric Mean Ratio (%)||90% Confidence Interval|Geometric Mean
1328193|NCT02130635|Secondary|Part B: Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Screening and Follow-up|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded.|Screening (up to 30 days prior to Day 1) and Follow-up (approximately Day 19)|Safety Population|||Liters||95% Confidence Interval|Mean
1328194|NCT02130635|Secondary|Part B: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline|Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
1328195|NCT02130635|Secondary|Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline|Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes [min] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
1328196|NCT02130635|Secondary|Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
1328197|NCT02130635|Secondary|Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Micromoles/Liter (micromol/L)||Standard Deviation|Mean
1328198|NCT02130635|Secondary|Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||International Units per Liter (IU/L)||Standard Deviation|Mean
1328199|NCT02130635|Secondary|Part B: Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||g/L||Standard Deviation|Mean
1328200|NCT02130635|Secondary|Part B: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||fL||Standard Deviation|Mean
1328201|NCT02130635|Secondary|Part B: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||pg||Standard Deviation|Mean
1328202|NCT02130635|Secondary|Part B: Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Ratio||Standard Deviation|Mean
1328203|NCT02130635|Secondary|Part B: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^12 cells/Liter (TI/L)||Standard Deviation|Mean
1328204|NCT02130635|Secondary|Part B: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||g/L||Standard Deviation|Mean
1328205|NCT02130635|Secondary|Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1328206|NCT02130635|Secondary|Part B: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of study treatment until follow-up (assessed for approximately 19 days)|Safety Population|||Participants|||Number
1328237|NCT02130284|Primary|Diabetic Ketoacidosis|Evaluation of DKA during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
1328210|NCT02130635|Secondary|Part B: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7|Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Concentration values were log-transformed. Day 7 sampling could be done on Day 7 or Day 8.|Day 7 immediately after dosing|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
1328211|NCT02130635|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7|Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Day 7 sampling could be done on Day 7 or Day 8.|Day 7 immediately after dosing|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
1328212|NCT02130635|Secondary|Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose|A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Concentration measurements were log-transformed. Only those participants who were available at the indicated time points were analyzed (represented by n=X,X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.|Pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, and 6 h post-dose on Day 1|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
1328213|NCT02130635|Secondary|Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose|A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Only those participants who were available at the indicated time points were analyzed (represented by n=X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.|Day 1 (Pre-dose, 5 min, 30 min, 1, 2, 4 & 6 hours post-dose)|PK Population: participants in the Safety Population for whom a PK sample was obtained and analyzed.|||pg/mL||95% Confidence Interval|Geometric Mean
1328214|NCT02130635|Primary|Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14|This outcome measure was used to estimate the inhibition levels of various doses of GSK2269557 by analyzing inflammatory cytokines IL6, IL8, and TNF alpha using Bayesian methods of statistical analysis, using non-informative prior distributions for all modeling parameters. Posterior medians (adjusted median response) and 95% credible intervals are reported here as medians and 95% confidence intervals respectively. 95% credible interval is reported as 2-sided 95% confidence in the statistical analyses. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 7 (pre-dose) and Day 14 (24 h post-dose)|Safety Population|||Picograms/milliliter (pg/mL)||95% Confidence Interval|Median
1328215|NCT02130635|Primary|Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points|Baseline is Day 1 pre-dose. FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded. Baseline was the maximum of the planned pre-dose measurements on Day 1. Change from Baseline at any post-dose time point was calculated as the post-dose value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 1 (1 h post-dose), Day 7 (pre-dose and 1 h post-dose), and Day 14 (24 h post-dose)|Safety Population|||Liters||95% Confidence Interval|Mean
1328216|NCT02130635|Primary|Part A: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline|Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Clinical significance was judged by the investigator. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
1328217|NCT02130635|Primary|Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline|Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes [min] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). Potential clinical concern range for SBP was <85 millimeters of mercury (mmHg) (low) and >160 mmHg (high), for DBP <45 mmHg (low) and >100 mmHg (high) and for HR <40 bpm and >110 bpm. All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
1328218|NCT02130635|Primary|Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
1328219|NCT02130635|Primary|Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Micromoles/Liter (micromol/L)||Standard Deviation|Mean
1328220|NCT02130635|Primary|Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||International Units per Liter (IU/L)||Standard Deviation|Mean
1328221|NCT02130635|Primary|Part A: Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||g/L||Standard Deviation|Mean
1328222|NCT02130635|Primary|Part A: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Femtoliters (fL)||Standard Deviation|Mean
1328223|NCT02130635|Primary|Part A: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Picograms (pg)||Standard Deviation|Mean
1328224|NCT02130635|Primary|Part A: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^12 cells/Liter (TI/L)||Standard Deviation|Mean
1328225|NCT02130635|Primary|Part A: Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Ratio||Standard Deviation|Mean
1328226|NCT02130635|Primary|Part A: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 h post-dose)|Safety Population|||Grams/Liter (g/L)||Standard Deviation|Mean
1328227|NCT02130635|Primary|Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1328228|NCT02130635|Primary|Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of study treatment until follow-up (assessed for approximately 19 days)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Number
1328229|NCT02130622|Secondary|The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).||4 weeks|Insufficient recruitment resulting in insufficient data to analyze||||||
1328230|NCT02130622|Secondary|Use of Rescue Medication|"Frequency of use of the rescue medication meclizine"|4 weeks|Data not collected||||||
1328231|NCT02130622|Secondary|Occurrence of Adverse Events||4 weeks|Insufficient recruitment resulting in insufficient data to analyze||||||
1328232|NCT02130622|Primary|Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4.||4 weeks|Insufficient recruitment resulting in insufficient data to analyze||||||
1328233|NCT02130284|Other Pre-specified|Device Metric/Performance - All Device Deficiencies||From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||device performance issues|||Number
1328234|NCT02130284|Other Pre-specified|Sensor Performance: Accuracy|MARD (Mean Absolute Relative Difference) between sensor glucose value and YSI. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|Total of 71 subjects completed the study. However, two subjects who withdrew also had YSI and Sensor glucose values. Therefore, total of 73 subjects contributed to sensor accuracy analysis|||percentage||Standard Deviation|Mean
1328235|NCT02130284|Other Pre-specified|PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.|Hypoglycemic event rate among 71 subjects who underwent the PLGM experiment. Hypoglycemic events are defined based on: occurrence of 2 or more continuous YSI <= 65 mg/dL during in-clinic procedures.|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|Two subjects were excluded from analysis because the site staff did not set the pump up correctly prior to YSI and the PLGM feature was never set to activate.|||percentage of total subjects|||Number
1328236|NCT02130284|Primary|Rescue Events During In-clinic Procedues||From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
1334068|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|3 months||||participants|||Number
1328239|NCT02130284|Primary|Unanticipated Device Effect (UADE)|Evaluation of incidence of UADE during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
1328240|NCT02130284|Primary|Serious Adverse Events (SAE)|Evaluation of incidence of SAE during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
1328241|NCT02130258|Primary|Post-epidural Cold Pain Threshold QST Results|The thermode is placed on the subject's arm. During the cold pain threshold test, the plate slowly decreases in temperature.The subject will stop the test when the plate is at their minimal tolerable temperature. This temperature is recorded and can range from 32-0 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.|4 weeks after the epidural injection||||Degrees Celsius||Standard Deviation|Mean
1328242|NCT02130258|Primary|Post-epidural Continued Pain Modulation (CPM)|CPM is a type of QST where the thermode is placed on the subject's non painful arm. Heat stimulation (47 degrees C, 4 seconds) was delivered to the thermode 4 times and the subject rated the pain felt by the heat stimulation on a visual analog scale (VAS) of 0-10. During the second heat stimulation, the subject immersed their hand (opposite from the arm with the thermode) in 12 degree C water and then rated the pain felt by the heat on a VAS of 0-10 (10 is the worst pain a subject can imagine, 0 is no pain). The final 2 heat stimuli were delivered (without using the hand submerged in water). This same test was repeated with the thermode on the subject's leg with radicular pain. The subject placed their hand contralateral to the painful leg in the cold water during the second heat stimulation. The VAS scores from each heat stimulation were averaged for the non-painful arm and the painful leg. The difference in averages between the arm and leg were then analyzed.|4 weeks after the epidural injection||||units on a scale||Standard Deviation|Mean
1328243|NCT02130258|Primary|Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results|QST tests for changes in spinal nerves. A small metal plate, called a thermode, is placed on the subject's arm. During the warm sensation test, the plate slowly increases in temperature.The subject will stop the test as soon as the plate feels warm. This temperature is recorded and can range from 32-53 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.|Baseline measurement before the epidural injection||||Degrees Celsius||Standard Deviation|Mean
1328244|NCT02130193|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)Score in Part B|Participants completed a PGIC questions at Week 4, 8, 16, 24, 40 and 52. Response options were on a 7 point Likert scale ranging from much better to much worse. PGIC was re-coded from a categorical to numerical value prior to analysis as: much worse = -3, worse = -2, slightly worse = -1, no change = 0, slightly better = 1, better = 2, much better = 3.A categorical summary of PGIC is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328245|NCT02130193|Secondary|Number of Participants With Patient Global Rating of Severity (PGRS) Score in Part B|PGRS is a single global question and was asked to participants to rate their COPD severity on a four point scale ranging from 1-4 (1=mild, 2=moderate, 3=severe, 4=very severe). Participants completed PGRS at Week 0, 4, 8, 16, 24, 40 and 52. Baseline was considered as score on Day 1. A categorical summary of PGRS is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328246|NCT02130193|Secondary|Number of Participants With Physician’s Global Assessment (PGA) Readings in Part B|The PGA is a single item clinician reported outcome measure assessing the overall severity of COPD. Physicians rated disease severity on a four point scale ranging from 1-4 (1=mild, 2=moderate, 3=severe, 4=very severe) at Week 0, 4, 8, 16, 24, 40 and 52. Baseline was considered as score on Day 1. A categorical summary of PGA is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328247|NCT02130193|Secondary|Change From Baseline for COPD Assessment Test (CAT) at the Indicated Time Points in Part B|The CAT is a validated, 8 item questionnaire which has been developed designed to measure overall COPD-related health status for the initial assessment and longitudinal follow up of par. with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (no impairment) to 5 (maximum impairment) with a total scoring range of 0 - 40. CAT was assessed at Baseline (Day 1), Day 28, Day 112, Day 168, Day 280 and Day 364 where Baseline was considered as score on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
1328248|NCT02130193|Secondary|Monthly Weighted Means of EXACT-RS Domain Scores in Part B|EXACT-RS is a tool which consists of 11 items from the 14 item EXACT-PRO instrument, intended to capture information related to the respiratory symptoms of COPD. EXACT-RS domains included breathlessness, cough and chest symptoms. The EXACT-RS has a scoring range of 0-40, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
1328249|NCT02130193|Secondary|Assessment of Severity of EXACT-PRO Events in Part B|EXACT-PRO tool was used to measure severity of COPD exacerbations in participants. Severity was indicated by the maximum EXACT-PRO total score during the course of event (from day of onset to day of recovery).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
1328399|NCT02127567|Secondary|The Score for Completeness of Reporting for Trial Design|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328250|NCT02130193|Secondary|Assessment of Duration of EXACT-PRO Events in Part B|Duration is the length of time in days from onset to recovery. It was calculated as the difference in days between day of onset and day of recovery. Onset of event was identified as either an increase in EXACT-PRO score of >=12 points above the par. current mean Baseline for 2 consecutive days, with Day 1 of the 2 days serving as Day 1 onset of the event, or an increase of >=9 points above the par. current mean Baseline for 3 consecutive days, with Day 1 of the 3 days serving as Day 1 onset of the event. Duration was 3-day rolling average was used, which was initiated on Day 1 of onset and ended on Day 1 of Recovery. Recovery was defined as the first day in which par. experienced a persistent, sustained improvement in their condition i.e. decrease in the rolling average EXACT-PRO total score >=9 point from the maximum observed value (highest rolling average EXACT-PRO total score observed the first 14 days of the event) during the first 14 days of an event that is sustained for 7 days.|Up to Day 392 in Part B|ITT Population|||Days||Standard Deviation|Mean
1328251|NCT02130193|Secondary|Time to First EXACT-PRO Event in Part B|The hazard ratio for the DNX versus placebo comparison, along with 95% credible interval and posterior probability was derived and a Bayesian Cox proportional hazards model was used for statistical analysis. The analysis was performed on ITT Population. One participant was excluded from analysis.|Up to Day 392 in Part B|ITT Population|||Days||Standard Deviation|Mean
1328252|NCT02130193|Secondary|Time to First HCRU COPD Exacerbation in Part B|HCRU COPD exacerbations are defined as moderate or severe exacerbations based on requirement of new prescription antibiotics or oral corticosteroids, hospitalization or emergency room visits for management of COPD exacerbation. The time to the first on-treatment HRCU exacerbation were summarized by treatment group. It was analyzed using a Bayesian Cox proportional hazards model. The hazard ratio for the danirixin vs. placebo comparison, along with 95 percent credible interval, was derived, with terms for treatment group, smoking status and country. Posterior probabilities of the ratio of the percentage of par. with an HCRU exacerbation, adjusted for time to first exacerbation, in the danirixin group relative to the placebo group were calculated. 1 par. was excluded from analysis.|Up to Day 392 in Part B|ITT Population|||Days||Standard Deviation|Mean
1328253|NCT02130193|Secondary|Monthly Weighted Means of Exacerbations of EXACT-PRO Total Score in Part B|EXACT-PRO is a 14 item patient reported outcome instrument designed to capture information on the occurrence, frequency, severity, and duration of COPD exacerbations. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed on the EXACT-PRO monthly weighted mean AUC data. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
1328254|NCT02130193|Secondary|Number of EXACT-PRO Exacerbations Per Year in Part B|EXACT-PRO is a 14 item patient reported outcome instrument designed to capture information on the occurrence, frequency, severity, and duration of COPD exacerbations. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. For par. with less than 364 days on-treatment, the annual exacerbation rate was imputed as the number of recorded on-treatment exacerbations, divided by the number of 4-week treatment period intervals for which the par. was in the study, multiplied by 13. For par. with 364 or more days on-treatment, the annual exacerbation rate was calculated as the number of recorded exacerbations between study days 1 and 364. Statistical analysis was done using a Bayesian Cox model, assuming a negative binomial distribution for the underlying exacerbation rate. The exacerbation rates and the ratio (danirixin/placebo), were estimated and 95 percent credible intervals were produced using non-informative priors. 1 par. was excluded from analysis.|Up to Day 392 in Part B|ITT Population|||Exacerbations per year||Standard Deviation|Mean
1328255|NCT02130193|Secondary|AUC(0-12) of Danirixin in Part B|AUC (0-12) of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population|||Hour*ng/mL||95% Confidence Interval|Geometric Mean
1328256|NCT02130193|Secondary|Tmax of Danirixin in Part B|Tmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population|||Hour||Full Range|Median
1328257|NCT02130193|Secondary|Cmax of Danirixin in Part B|Cmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population|||ng/mL||95% Confidence Interval|Geometric Mean
1328268|NCT02130193|Primary|Change From Baseline in Urine Power of Hydrogen (pH) at Day 14 in Part A|Urinalysis including urine pH was done at Screening and Day 14 in Part A. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population|||pH||Standard Deviation|Mean
1328269|NCT02130193|Primary|Number of Participants With Urinalysis Dipstick Results in Part B|Test strip urinalysis was done for glucose, ketones, occult blood and protein at Screening and on Day 28, 168, 224 and 364 in Part B. Results were presented as negative, trace, 1+, 2+ and 3+ for glucose, ketones, occult blood and protein. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328258|NCT02130193|Primary|Monthly Weighted Means of Exacerbations of Chronic Pulmonary Disease Tool-respiratory Symptoms (EXACT-RS) Total Score in Part B|EXACT-RS is a tool which consists of 11 items from the 14 item EXACT- patient reported outcomes (EXACT-PRO) instrument, intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The EXACT-RS has a scoring range of 0-40, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed on the EXACT-RS monthly weighted mean AUC data. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
1328259|NCT02130193|Primary|Number of Health Care Resource Utilization (HCRU) Defined COPD Exacerbations Per Year in Part B|HCRU COPD exacerbations are defined as moderate or severe exacerbations based on requirement of new prescription antibiotics or oral corticosteroids, hospitalization or emergency room visits for management of COPD exacerbation. For par. with less than 364 days on-treatment, the annual exacerbation rate was imputed as the number of recorded on-treatment exacerbations, divided by the number of 4-week treatment period intervals for which the par. was in the study, multiplied by 13. For par. with 364 or more days on-treatment, the annual exacerbation rate was calculated as the number of recorded exacerbations between study days 1 and 364. Statistical analysis was done using a Bayesian Cox model, assuming a negative binomial distribution for the underlying exacerbation rate. The exacerbation rates along with the ratio (danirixin/placebo), were estimated and corresponding 95 percent credible intervals were produced using non-informative priors. 1 par. was excluded from the analysis.|Up to Day 392 in Part B|ITT Population|||Exacerbations per year||Standard Deviation|Mean
1328260|NCT02130193|Primary|Area Under the Blood Concentration-time Curve (AUC) Over Dosing Interval (AUC[0-12]) of Danirixin in Part A|AUC (0-12) of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods. A Bayesian random effects model was performed adjusting for the trial as a random effect. A non-informative normal prior distribution was used. Point estimates and corresponding 90 percent credible intervals were constructed.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population|||Hour*ng/mL||95% Confidence Interval|Geometric Mean
1328261|NCT02130193|Primary|Time of Occurrence of Cmax (Tmax) of Danirixin in Part A|Tmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population|||Hour||Full Range|Median
1328262|NCT02130193|Primary|Maximum Observed Plasma Concentration (Cmax) of Danirixin in Part A|Cmax of danirixin was derived from the Pharmacokinetics (PK) samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods. PK Concenteration Population comprised of par. in the ITT Population and who had provided at least one on-treatment blood sample for determination of danirixin concentration.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1328263|NCT02130193|Primary|Change From Baseline in FEV1 and FVC at the Indicated Time Points in Part B|FEV1 and FVC were performed at Screening and on Day 1, 28, 56, 112, 168, 280, 364 and at Follow-up (Day 378 to 392) in Part B. FEV1 and FVC assessments at each time point (post-bronchodilator) were taken in triplicate. The maximum of the triplicate assessments were used. Baseline was considered as the measurement obtained at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Statistical analysis was performed using a repeated measures mixed effects model in a Bayesian framework. The estimate of the treatment difference and corresponding 95 percent credible interval was constructed for the difference between danirixin and placebo for each visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Liter||Standard Deviation|Mean
1328264|NCT02130193|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points in Part A|FEV1 measures how much air a person can exhale during a forced breath in 1 second. FVC is the total amount of air exhaled during the FEV test. FEV1 and FVC were performed at Screening and on Day 1, 14 and at Follow-up visit (Day 21 to 28). FEV1 and FVC assessments at each time point (post-bronchodilator) were taken in triplicate. The maximum of the triplicate assessments were used. Baseline was considered as the measurement obtained at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population|||Liter||Standard Deviation|Mean
1328265|NCT02130193|Primary|Change From Baseline in Urine Specific Gravity of Urine in Part B|Urinalysis including urine specific gravity was done at Screening and on Day 28, 168 and 364 in Part B. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 392 in Part B|ITT Population|||urine specific gravity||Standard Deviation|Mean
1328266|NCT02130193|Primary|Change From Baseline in Urine Specific Gravity of Urine in Part A|Urinalysis including urine specific gravity was done at Screening and Day 14 in Part A. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population|||urine specific gravity||Standard Deviation|Mean
1328267|NCT02130193|Primary|Change From Baseline in Urine pH in Part B|Urinalysis including urine pH was done at Screening and on Day 28, 168 and 364 in Part B. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||pH||Standard Deviation|Mean
1328270|NCT02130193|Primary|Number of Participants With Urinalysis Dipstick Results in Part A|Test strip urinalysis was done for glucose, ketones, occult blood and protein at Screening and Day 14 in Part A. Results were presented as negative, trace, 1+, 2+ and 3+ for glucose, ketones, occult blood and protein. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 28 in Part A|ITT Population|||Participants|||Number
1328271|NCT02130193|Primary|Number of Participants With Clinical Chemistry Values of Potential Clinical Importance in Part B|Blood samples were collected at Screening and on Day 28, 168 and 364 in Part B to evaluate clinical chemistry parameters which included ALT, albumin, ALP, AST, total bilirubin, calcium, bicarbonate, chloride, creatinine, direct bilirubin, GGT, glucose, potassium, total protein, sodium, BUN and uric acid. Clinical chemistry values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328272|NCT02130193|Primary|Number of Participants With Clinical Chemistry Values of Potential Clinical Importance in Part A|Blood samples were collected at Screening and Day 14 in Part A to evaluate clinical chemistry parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, calcium, bicarbonate, chloride, creatinine, direct bilirubin, gamma glutamyl transferase (GGT), glucose, potassium, total protein, sodium, blood urea nitrogen (BUN) and uric acid. Additional liver monitoring chemistry (ALT, AST, ALP and total and direct bilirubin) was done on Day 1 pre-dose. Clinical chemistry values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
1328273|NCT02130193|Primary|Number of Participants With Hematology Values of Potential Clinical Importance in Part B|Blood samples were collected at Screening and on Day 28, 168, and 364 in Part B to evaluate hematology parameters which included hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCHC, MCH, MCV, RBC count, WBC count, platelet count and reticulocyte count. Hematology values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328274|NCT02130193|Primary|Number of Participants With Hematology Values of Potential Clinical Importance in Part A|Blood samples were collected at Screening and Day 14 in Part A to evaluate hematology parameters which included hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count, platelet count and reticulocyte count. Hematology values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
1328275|NCT02130193|Primary|Number of Participants With Abnormal 12-lead ECG in Part B|12-lead ECG was taken on Day 1 pre-dose and on Day 28, 168 and at Follow-up (Day 378 to 392) in Part B using an ECG machine. Participants with abnormal-NCS and abnormal-CS findings were sumarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328276|NCT02130193|Primary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) in Part A|12-lead ECG was taken on Day 1 pre-dose and on Follow-up visit (Day 21 to 28) in Part A using an ECG machine. Triplicate reading were taken on Day 1 pre-dose. Participants with abnormal-clinically not significant (NCS) and abnormal-clinically significant (CS) findings were sumarized.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
1328277|NCT02130193|Primary|Number of Participants With Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Pulse Rate and Respiratory Rate Abnormalities of Potential Clinical Importance in Part B|Vital signs including SBP, DBP, pulse rate and respiratory rate were taken on Day 1 pre-dose and on Day 28, 56, 112, 168, 280, 364 and at Follow-up (Day 378 to 392) in Part B. Measurements were obtained in a semi-supine/ supine position after 5 minutes rest. The mean of replicate assessments at any given time point was used as the value for that time point. SBP <90 or >160 mmHg, DBP <40 or >110 mmHg, pulse rate <35 or >120 bpm and respiratory rate <8 or >30 breaths per minute were considered as values of potential clinical importance and were presented as 'High' or 'Low' values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
1328278|NCT02130193|Primary|Number of Participants With Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Pulse Rate, Respiratory Rate and Body Temperature Abnormalities of Potential Clinical Importance in Part A|Vital signs including SBP, DBP, pulse rate, respiratory rate and body temperature were taken on Day 1 pre-dose and on Day 14 and at Follow-up (Day 21 to 28) in Part A. Measurements were obtained in a semi-supine/ supine position after 5 minutes rest. The mean of replicate assessments at any given time point was used as the value for that time point. SBP <90 or >160 millimeter of mercury (mmHg); DBP <40 or >110 mmHg, pulse rate <35 or >120 beats per minute (bpm) and respiratory rate <8 or >30 breaths per minute were considered as values of potential clinical importance and were presented as 'High' or 'Low' values. Intent-to-Treat (ITT) Population comprised of all randomized par. who received at least one dose of study medication.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
1328279|NCT02130193|Primary|Number of Participants With Any AE and SAE in Part B|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were categorized as SAE. Participants with AE or SAE occurrences >= 5 percent were summarized.|Up to Day 392 in Part B|All Subjects Population|||Participants|||Number
1328280|NCT02130193|Primary|Number of Participants With Any Adverse Event (AE) and, Serious Adverse Event (SAE) in Part A|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were categorized as SAE. Participants with any AE or SAE were summarized. Participants with AE or SAE occurrences >= 5 percent were summarized. All Subjects Population comprised of all participants who were screened and for whom a record existed on the study database.|Up to Day 28 in Part A|All Subjects Population|||Participants|||Number
1328281|NCT02130063|Secondary|Change in TSAT||From baseline to week 1, 2, 4, and 5||||percent||Standard Deviation|Mean
1328282|NCT02130063|Secondary|Change in S-ferritin Concentration||From baseline to week 1, 2, 4, and 5|FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.|||ng/mL||Standard Deviation|Mean
1328283|NCT02130063|Secondary|Change in Hb Concentration||From baseline to week 2, 4 and 5|FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.|||g/dL||Standard Deviation|Mean
1328284|NCT02130063|Primary|Number of Subjects With an Hb Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5|"The primary efficacy endpoint of the trial was the proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. ‘Any time’ implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder.~Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised."|From baseline to week 5|FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.|||participants|||Number
1328285|NCT02129777|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328286|NCT02129777|Secondary|Change From Baseline in EQ-5D-VAS Score at Week 12|EQ-5D-VAS is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (“Worst imaginable health state”) to 100 mm (“Best imaginable health state”); higher scores indicate a better health state.|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||millimeter (mm)||Standard Error|Least Squares Mean
1328287|NCT02129777|Secondary|Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12|EQ-5D-Index score is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000. The higher score indicates a better health state perceived by the participant.|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328288|NCT02129777|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328289|NCT02129777|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-point rating scale for determining the impact of dermatological conditions on the participant’s quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Maximum total score is 30, where 0-1 represents “No effect at all on participant's life” and 21-30 “Extremely large effect on participant's life” - higher scores indicating poorer quality of life.|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328290|NCT02129777|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Duration of stiffness was elicited in response to a standard question included in the portable device.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||minutes||Standard Error|Least Squares Mean
1328291|NCT02129777|Secondary|Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of morning stiffness by marking a horizontal line with “No stiffness” at the left extreme and “Very severe stiffness” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of stiffness experienced by the participant since waking on that particular day.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328292|NCT02129777|Secondary|Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their severity of joint pain by marking a horizontal line with “No pain” at the left extreme and “Worst pain imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of pain experienced during the previous 24 hours.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328293|NCT02129777|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of itching by marking a horizontal line with “No itch” at the left extreme and “Worst itch imaginable” at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of itching experienced during the previous 24 hours.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328294|NCT02129777|Secondary|Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12|Assessment of BSA with psoriasis was performed by means of the palm method, where the palm of the participant’s hand represented 1% of BSA. The affected areas were then calculated by their size compared to the participant’s palm.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of total body surface area||Standard Error|Least Squares Mean
1328295|NCT02129777|Secondary|Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe).|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328296|NCT02129777|Secondary|Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). ‘Clear’ and 'Almost clear’ included all participants who had scored a 0 or 1.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
1328297|NCT02129777|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). Participants who had >=2 point improvement are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
1328298|NCT02129777|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 90% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
1328308|NCT02129192|Primary|Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet|Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|FEAS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328299|NCT02129777|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 50% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
1328300|NCT02129777|Secondary|Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
1328301|NCT02129777|Secondary|Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6 and 10|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
1328302|NCT02129777|Primary|Percentage of Participants Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90–100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.|Week 12|Full analysis set (FAS) where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
1328303|NCT02129725|Primary|Insulin-stimulated AKT Phosphorylation|"measured using Western blot for pAkt and for total Akt from muscle biopsies obtained at the end of the baseline hyperinsulinemic clamp and the three-month hyperglycemic clamp.~The ratio of pAkt to Akt expression was calculated at each time point and the change in ratio from 0 to 3 months is presented."|3 months||||change in ratio||Standard Deviation|Mean
1328304|NCT02129608|Primary|Change in Weight|The change in weight from baseline to 3 months|3 months||||kg||Standard Deviation|Mean
1328305|NCT02129608|Primary|Change in Waist Circumference|The change in waist circumference from baseline to 3 months|3 months||||cm||Standard Deviation|Mean
1328306|NCT02129192|Secondary|Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet|Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|FEAS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328307|NCT02129192|Secondary|Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity|Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328334|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.|Up to Posttreatment Week 12|Participants in the Full Analysis Set with available data were analyzed|||Percentage of participants|||Number
1328309|NCT02129192|Primary|Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration|Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328310|NCT02129192|Primary|Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet|Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|Food effect analysis set (FEAS) which included healthy subjects of treatment sequence TRRTT in the TS who were judged appropriate to continue to period 5 by the investigator, had evaluable PK variables for both feeding conditions and did not have an important protocol violation relevant to relative bioavailability evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328311|NCT02129192|Primary|Maximum Measured Concentration (Cmax) of the Analytes in Plasma|Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|Pharmacokinetic set (PKS) which included all healthy subjects in the TS who had evaluable PK variables for both treatments (i.e. had data of at least one analyte for both test and reference products) in periods 1, 2, 3 and 4. Subjects who had an important protocol violation relevant to PK evaluation were to be excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328312|NCT02129062|Primary|Overall Survival Time|The time measurement from beginning treatment to recurrent or progressive disease is objectively documented. Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups such as age groups, or Philadelphia chromosome-positive versus Philadelphia chromosome-negative B-ALL. Progressive disease is defined as a doubling of the peripheral blasts and an absolute increase of > 5 x 10^9/L.|Up to thirty days after after completion of study treatment anticipated to be 12 weeks for total of 16 weeks|Study terminated early due to slow enrollment, insufficient data . One participant was not evaluable due to early death, other two participants were removed from the study within 30 days of study start due to disease progression prior to scheduled treatment evaluations.||||||
1328313|NCT02129062|Primary|Objective Response Rate (ORR)|ORR is defined as the proportion of participants with complete or partial response. Response definitions of Complete Response (CR): disappearance of leukemia as indicated by <5% marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) >1000/μL & platelets >100,000/μL. C1 extramedullary disease status required. CR with incomplete count recovery (CRi): CR except with ANC <1000/μL and/or platelets <100,000/μL. Partial response (PR): improved or no worsening of ALL as indicated by no peripheral blood blasts, neutrophils >1000/μL, platelets >100,000μL, and either or both of the following: >50% decrease in marrow blast percentage, compared to pretreatment value, & marrow blast percentage ≥ 5% and ≤ 25%. C2 extramedullary disease status. Treatment failures are defined as participants who fail to achieve CR, CRi or PR.|3 months after treatment|One of three participants was not evaluable for response.|||percentage of participants|||Number
1328314|NCT02128997|Secondary|Postpartum Length of Stay||Until hospital discharge and then for 4 weeks follow up||||days||Inter-Quartile Range|Median
1328315|NCT02128997|Secondary|Tingling Pain Scores|On postoperative day 2, all patients were administered a pain scale: Rank tingling pain (0–10), 10 being worst possible tingling pain|Postpartum day 2||||Unit on a scale||Inter-Quartile Range|Median
1328316|NCT02128997|Secondary|Pain Scores|On postoperative day 2, all patients were administered a pain scale: Rank sharp pain (0–10), 10 being worst possible sharp pain.|Postpartum day 2||||Unit on a scale||Inter-Quartile Range|Median
1328317|NCT02128997|Primary|Number of Participants With Wound Complications|The primary outcome variable was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening|Four weeks after cesarean section||||Participants|||Count of Participants
1328318|NCT02128932|Secondary|Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)|Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment|After 30 weeks treatment|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||Count of participants|||Number
1328319|NCT02128932|Secondary|Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)|The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject’s treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||Score on a scale||Standard Error|Least Squares Mean
1328335|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Breakthrough|"Viral breakthrough was defined as either:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment~HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values"|Up to Posttreatment Weak 12|Full Analysis Set|||Percentage of participants|||Number
1328320|NCT02128932|Secondary|Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™|The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject’s overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||T-scores||Standard Error|Least Squares Mean
1328321|NCT02128932|Secondary|Change in Systolic Blood Pressure.|Change in systolic blood pressure from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||mmHg||Standard Error|Least Squares Mean
1328322|NCT02128932|Secondary|Change in Diastolic Blood Pressure.|Change in diastolic blood pressure from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||mmHg||Standard Error|Least Squares Mean
1328323|NCT02128932|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||mg/dL||Standard Error|Least Squares Mean
1328324|NCT02128932|Secondary|Change in Body Weight From Baseline|Change in body weight from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||Kg||Standard Error|Least Squares Mean
1328325|NCT02128932|Primary|Change in HbA1c From Baseline|Change in HbA1c from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomized semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||percentage||Standard Error|Least Squares Mean
1328326|NCT02128919|Other Pre-specified|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.|Baseline and after 5 tDCS sessions||||Units on a scale||Standard Deviation|Least Squares Mean
1328327|NCT02128919|Secondary|Change From Baseline in Cognitive Performance|The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance. Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests. We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.|Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)||||MATRICS domain difference scores||Standard Deviation|Least Squares Mean
1328328|NCT02128919|Primary|Change From Baseline in Cigarette Craving|"The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings. Scores ranged from a minimum of 1 (Strongly Disagree) to a maximum of 7 (Strongly Agree) and were determined by self-reported responses to 10 statements about having cravings for smoking. Scores closer to 1 after treatment would indicate a better outcome. Responses to each of the 10 items in the scale were summed for one total score. With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70."|Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)|Findings are based on31 subjects (15 active tDCS and 16 sham tDCS) who completed this QSU-Brief questionnaire in at baseline and after 5 tDCS sessions.. Complete sample who entered study and were randomized were 33 subjects 24 male and 9 female, but all subjects did not complete QSU brief rating scale..|||Units on QSU-Brief Scale||Standard Error|Least Squares Mean
1328329|NCT02128867|Other Pre-specified|Sa02|SaO2 will be measured during 15 minutes of treatment time|15 minutes|||||||
1328330|NCT02128867|Other Pre-specified|Heartrate|heartrate will be measured during 15 min of treatment time|15 minutes|||||||
1328331|NCT02128867|Secondary|Duration of Reflux Episodes|duration of reflux episodes will be measured during 15 min of treatment time|15 minutes|||||||
1328332|NCT02128867|Primary|Number of Refluxes|number of refluxes will be counted over a period of 15 minutes ( treatment time )|15 minutes||||number of refluxes||Standard Deviation|Mean
1328333|NCT02128542|Secondary|Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment|Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L.|Pretreatment and Posttreatment Week 12|Participants who relapsed and qualified for sequencing analysis were analyzed.|||participants|||Number
1328400|NCT02127567|Secondary|The Score for Completeness of Reporting for Outcomes|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328336|NCT02128542|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1328337|NCT02128542|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug|||Percentage of participants|||Number
1328338|NCT02128542|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1328339|NCT02128490|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
1328340|NCT02128490|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1328341|NCT02128490|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
1328342|NCT02128269|Primary|Safety and Tolerability of Intravenous (IV) ALXN1007 as Measured by Percentage of Patients Reporting Adverse Events||Treatment Period (24 weeks)||||Participants|||Count of Participants
1328343|NCT02128217|Secondary|Concentration of Tenofovir (TFV) in Plasma|Concentration of tenofovir (TFV) in plasma among participants who took TFV for treatment of HIV infection.|Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who started first dose of study treatment and also took tenofovir (TFV) for treatment of HIV infection.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328344|NCT02128217|Secondary|Concentration of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs)|Concentration of tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs). This outcome is measured in Cohort 1 only.|Baseline (before SOF + RBV dosing), EOT (end of study treatment), 12 weeks after end of HCV study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV and who were also taking tenofovir disoproxil fumarate (TDF) for treatment of HIV infection.|||fmol/10^6 cells||Geometric Coefficient of Variation|Geometric Mean
1328345|NCT02128217|Secondary|Cellular Concentration of Tenofovir Diphosphate (TFV-DP)|Cellular concentration of tenofovir diphosphate (TFV-DP) from dried blood spot samples.|Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who started first dose of study treatment and also took tenofovir disoporxil fumarate (TDF) for treatment of HIV infection.|||fmol/punch||Geometric Coefficient of Variation|Geometric Mean
1328346|NCT02128217|Secondary|Ribavirin Concentration in Plasma|Ribavirin concentration in plasma. This outcome was evaluated in Cohort 1 only.|4, 8, and 12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328347|NCT02128217|Secondary|Adherence as Measured by LDV/SOF Pill Count|The count and percentage of participants who had a pill count consistent with 100% of LDV/SOF doses taken.. This outcome measure was evaluated in Cohort 2 only.|8 weeks after starting study treatment.|Participants in Cohort 2 who successfully enrolled and received first dose of LDV/SOF.|||Participants|||Count of Participants
1328348|NCT02128217|Secondary|Self-reported Adherence to LDV/SOF|Count and percentage of participants who reported having taken all doses of LDV/SOF. This outcome measure was evaluated in Cohort 2 only.|1, 2, 4, and 8 weeks after starting study treatment.|Participants in Cohort 2 who successfully enrolled and received first dose of LDV/SOF.|||Participants|||Count of Participants
1328349|NCT02128217|Secondary|Adherence as Measured by RBV Pill Count|The count and percentage of participants who had a pill count consistent with 100% of RBV doses taken. This outcome measure was evaluated in Cohort 1 only.|12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV.|||Participants|||Count of Participants
1328350|NCT02128217|Secondary|Self-reported Adherence to RBV|Count and percentage of participants who reported having taken all doses of RBV. This outcome measure was evaluated in Cohort 1 only.|1, 2, 4, 8 and 12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.|||Participants|||Count of Participants
1328351|NCT02128217|Secondary|Adherence as Measured by SOF Pill Count|The count and percentage of participants who had a pill count consistent with 100% of SOF doses taken. This outcome measure was evaluated in Cohort 1 only.|12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.|||Participants|||Count of Participants
1328352|NCT02128217|Secondary|Self-reported Adherence to SOF|Count and percentage of participants who reported having taken all doses of SOF. This outcome measure was evaluated in Cohort 1 only.|1, 2, 4, 8 and 12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.|||Participants|||Count of Participants
1328353|NCT02128217|Secondary|Change in CD4+ Cell Count|The change in CD4+ cell count from baseline to 12 weeks after the end of study treatment.|Baseline to 12 weeks after end of study treatment. Duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who successfully enrolled and recieved first dose of treatment.|||cells/mm^3||Standard Deviation|Mean
1328354|NCT02128217|Secondary|Count of Participants With HIV-1 RNA <50 Copies/mL|Because all except one participant had HIV-1 RNA < 50 copies/mL, participants were categorized according to whether or not their HIV-1 RNA was <5 copies/mL at each follow-up evaluation.|4 and 12 weeks after start of study treatment for Cohort 1. 4 and 8 weeks after start of study treatment for the 8-week regimen used in Cohort 2)|Participants who enrolled successfully, received HIV ARV regimen at entry and started first dose of treatment|||Participants|||Count of Participants
1328355|NCT02128217|Secondary|Count and Percentage of Participants With an Adverse Event by Type.|The adverse events considered were Grade 2 or higher adverse events (primary diagnosis, primary sign and symptom, or a primary lab), SAE according to ICH criteria, or treatment-limiting adverse events. Participants may experience more than one type of adverse event.|Any time from start of treatment to 28 days after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who successfully enrolled and received first dose of treatment.|||Participants|||Count of Participants
1328356|NCT02128217|Secondary|Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations|Percentage of participants who developed SOF- or LDV-associated resistance mutation found within HCV Virologic Failure participants. HCV virologic failure was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable.|At time of HCV virologic failure; any time from start of study treatment to 24 weeks after end of study treatment. Duration of study treatment for Cohort 1 and 2 were 12 and 8 weeks, respectively.|Participants who observed an HCV virologic failure after successfully enrolling for first dose of treatment.|||Percentage of participants|||Number
1328357|NCT02128217|Secondary|Number of Participants Who Had HCV Virologic Relapse|HCV virologic relapse was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable.|From end of study treatment through to 24 weeks after end of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who successfully enrolled and started first dose of treatment.|||Participants|||Count of Participants
1328358|NCT02128217|Secondary|Percentage of Participants With HCV RNA Undetectable After End of Study Treatment|"HCV RNA undetectable is defined as an HCV RNA measurement <LLOQ, TND. If there was no measurement at a scheduled time, then the participant was considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements were undetectable. This outcome measure was referred to as SVR2, SVR4, SVR8 and SVR24 where SVR means sustained virologic response.~A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method."|2, 4, 8 and 24 weeks after last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|"Participants who successfully enrolled and started first dose of treatment.~Note that one participant in Cohort 2 was lost to follow-up prior to week 24 and is imputed as not having SVR24 at week 24. This participant, however, had HCV RNA < LLOQ, TND at all moments from week 4 of study treatment."|||Percentage of participants||90% Confidence Interval|Number
1328359|NCT02128217|Secondary|Percentage of Participants With HCV RNA Undetectable During Study Treatment|"HCV RNA undetectable was defined as an HCV RNA measurement <LLOQ, TND. If there was no measurement at a scheduled time, then the participant was considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements were undetectable.~A two-sided 90% confidence interval was calculated for each proportion using the Blyth-Still-Casella method."|1, 2, 4, 8 and, for the 12-week regimen, 12 weeks after starting study treatment.|Participants who successfully enrolled and started first dose of treatment.|||Percentage of participants||90% Confidence Interval|Number
1328360|NCT02128217|Primary|Percentage of Participants With an Occurrence of a Grade ≥ 2 Adverse Event, Serious AE According to ICH Criteria, or Treatment-limiting AE.|"Any adverse event occurring after initiation of study treatment through to 28 days after the date of last dose of study treatment was included (except that an event that was ongoing at the same grade from before start of study treatment was excluded). Adverse events consisted of Grade ≥ 2 primary diagnosis, primary sign/symptoms, and primary laboratory abnormality. It also included any serious adverse event according to ICH criteria and any treatment-limiting AE (ie, an AE reported as the reason for permanent discontinuation of study treatment).~A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method."|From initiation of study treatment to 28 days after last dose of study treatment. The duration for study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who enrolled and started first dose of study treatment.|||Percentage of participants||90% Confidence Interval|Number
1328361|NCT02128217|Primary|Percentage of Participants With Sustained Virologic Response 12 (SVR12)|"SVR12 was defined as HCV RNA undetectable less than the lower limit of quantification, Target Not Detected (<LLOQ TND) of the assay at 12 weeks after date of last dose of study treatment.~For both Cohort 1 and Cohort 2, the 12 week measurement used for determining SVR12 was the measurement obtained closest to 84 days (i.e. 12*7 days), within the window 79 to 112 days inclusive. If a participant did not have an HCV RNA measurement within this window, then the participant was considered as having detectable HCV RNA at 12 weeks unless the preceding and subsequent HCV RNA measurements were both undetectable (<LLOQ TND).~A two-sided 90% confidence interval was calculated for this percentage using the Blyth-Still-Casella method."|At 12 weeks after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who enrolled and started at least one dose of study treatment|||Percentage of participants||90% Confidence Interval|Number
1328362|NCT02128074|Primary|Change in Hemoglobin From Baseline to the End of 8-week Treatment Period||8 weeks||||g/dL||Standard Deviation|Mean
1328374|NCT02127892|Other Pre-specified|Number of Participants With Veno-occlusive Disease (VOD) - Moderate and Severe|Evaluation of veno-occlusive disease determined by the presence of the following features; fluid retention, weight gain, leaky capillary syndrome, painful liver enlargement, refractoriness to platelet tranfusion and hyperbilirubinemia|100 days||||Participants|||Count of Participants
1328363|NCT02127970|Other Pre-specified|Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response|The SSTI-C Questionnaire is an 11-item self-reported questionnaire that measures subjective experiences of the participant. One of the items assessed was overall satisfaction with treatment. Participants answered the question: “Overall, how satisfied were you with your antibiotic treatment?” using one of the following responses: Extremely satisfied, Moderately satisfied, Not at all satisfied, Slightly satisfied and Very satisfied. The percentage of participants in each category is reported.|EOT (Day 14-15)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
1328364|NCT02127970|Other Pre-specified|Percentage of Participants by Resource Utilization Categories|Resource Utilization Categories included: Any additional visits (including urgent care), Any additional procedures, Any additional tests, Any home visits or nursing care and Any ER Visits. The percentage of participants in each category is reported.|Final Visit (Day 28 +/- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
1328365|NCT02127970|Other Pre-specified|Change From Baseline in Participant's Assessment of Pain|Using the Brief Pain Inventory Scale, participants rated their pain “right now” on a scale where: 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 + /- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||pain score||Standard Deviation|Mean
1328366|NCT02127970|Other Pre-specified|Percentage of Participants With Complete Resolution of Local Signs of Infection|Resolution of Local Signs of Infection that include absence of purulence/drainage, erythema, heat/localized warmth, pain/tenderness to palpation, fluctuance, and swelling/induration.|Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
1328367|NCT02127970|Other Pre-specified|Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline|A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given.|Day 3-4 and EOT (Day 14-15)|Microbiological Intent-to-treat (MicroITT) Population included all ITT participants who had at least 1 Gram-positive bacterial pathogen isolated at Baseline. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
1328368|NCT02127970|Other Pre-specified|Percentage of Participants by Investigator Assessment of Clinical Outcome|A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given. An unsuccessful outcome was the opposite of successful. An Indeterminate outcome was defined as any of the data needed to determine a successful or unsuccessful outcome were missing.|Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
1328369|NCT02127970|Other Pre-specified|Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)|Clinical Success was defined as localized fluctuance and heat/warmth that if present at Baseline must be improved and no worse than mild. Clinical Failure was defined as the opposite to success. Clinical status was Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.|EOT (Day 14-15)|ITT Population included all randomized participants regardless of whether or not they received study drug.|||percentage of participants|||Number
1328370|NCT02127970|Secondary|Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)|Clinical Success is defined as follows: For evaluation at EOT visit, lesion area must be decreased by ≥80% from baseline and at FV lesion area must be decreased by ≥90% from baseline; Temperature is ≤37.6°C; Local signs of tenderness to palpation and swelling/induration are no worse than mild; For evaluation at EOT visit, local signs of fluctuance and localized heat/warmth must be improved from baseline and no worse than mild, and at FV local signs of fluctuance and localized heat/warmth must be absent; for participants with a wound infection the severity of purulent drainage is improved and no worse than mild relative to baseline. Clinical Failure is defined as the opposite to success or if the participant died during the study period up to visit or received study therapy for ABSSSI beyond the protocol treatment period. Clinical status is Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.|End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of study drug)|ITT Population included all randomized participants regardless of whether or not they received study drug.|||percentage of participants|||Number
1328371|NCT02127970|Primary|Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug|Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant’s ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpendicular width) relative to the baseline measurement.|Up to 48-72 hours after the initiation of study drug|ITT Population included all randomized participants regardless of whether or not they received study drug.|||percentage of participants|||Number
1328372|NCT02127892|Other Pre-specified|Overall Survival|Overalls survival of patient at 1 year post transplant|1 year||||Participants|||Count of Participants
1328373|NCT02127892|Other Pre-specified|Number of Participants With Graft Versus Host Disease (GVHD) - Grade III or IV|GVHD disease surveillance done by clinical evaluation, to include history, physical examination, specifically for rash, jaundice, liver dysfunction, nausea and vomiting, diarrhea and failure to thrive.|1 year||||Participants|||Count of Participants
1328376|NCT02127892|Primary|Number of Participants With Engraftment|Engraftment is defined as recovery of blood counts (neutrophil and platelet engraftment) with cells of donor origin, documented by either bone marrow or peripheral blood chimerism assays after hematopoietic stem cell transplant.|100 day||||Participants|||Count of Participants
1328377|NCT02127710|Secondary|Elimination Half-Life of AZD6094 After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||Hours||Standard Deviation|Mean
1328378|NCT02127710|Secondary|Mean Residence Time of AZD6094 After Single Dose|The number of patients analysed represent the number of evaluable PK parameters for this endpoint.|24 Hours||||Hours||Standard Deviation|Mean
1328379|NCT02127710|Secondary|Apparent Total Clearance of AZD6094 From Plasma After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||L/hour||Standard Deviation|Mean
1328380|NCT02127710|Secondary|Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose (Time Zero to Last Measurement)|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||h*ng/mL||Standard Deviation|Mean
1328381|NCT02127710|Secondary|Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||h*ng/mL||Standard Deviation|Mean
1328382|NCT02127710|Secondary|Apparent Volume of Distribution of AZD6094 Following Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||Liters||Standard Deviation|Mean
1328383|NCT02127710|Secondary|Time to Peak Plasma Concentration of AZD6094 After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||Hours||Full Range|Median
1328384|NCT02127710|Secondary|Peak Plasma Concentration of AZD6094 Following Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||ng/mL||Standard Deviation|Mean
1328385|NCT02127710|Secondary|Duration of Response|Duration of Response is the time from the first documentation of confirmed complete response/partial response until the date of progression, or death in the absence of progression. There were 8 responders: one of whom subsequently progressed or died and seven of whom were still classified as responders at the time of data cut-off and were therefore censored. It was not possible to determine a median or 75th percentile.|Up to 12 months||||Weeks||Inter-Quartile Range|Median
1328386|NCT02127710|Secondary|Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.|12 week summary for patients in the Safety analysis set by MET Status. The number of patients analysed represent the number of evaluable patients at the 12 week timepoint.|12 Weeks (at 12 week timepoint)||||Percent change||Standard Deviation|Mean
1328387|NCT02127710|Secondary|Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set|12 week summary for patients in the Efficacy analysis set, by MET status. The numbers of patients analysed represent the numbers evaluable at the 12 week timepoint.|12 Weeks (at 12 weeks timepoint)||||Percent change||Standard Deviation|Mean
1328388|NCT02127710|Secondary|Overall Survival Stratified by c-MET Status in the Safety Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
1328389|NCT02127710|Secondary|Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
1328390|NCT02127710|Secondary|Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
1328391|NCT02127710|Secondary|Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
1328392|NCT02127710|Primary|Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set|The primary outcome measure was ORR, defined as the proportion of patients with either a confirmed complete response/partial response by investigator assessment according to RECIST v1.1.|12 Months|ORR was assessed on the safety analysis set, consisting of all patients who received at least one dose of the study drug (n = 109).|||Participants|||Count of Participants
1328393|NCT02127710|Primary|Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set|The primary outcome measure was ORR, defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to RECIST v1.1.|12 Months|ORR was assessed on the efficacy analysis set, consisting of all patients with measurable disease, PRCC confirmed by a central laboratory and received at least 1 dose of AZD6094 (n = 84).|||Participants|||Count of Participants
1328394|NCT02127710|Primary|Objective Response Rate (RECIST Version 1.1)|The primary outcome measure was Objective Response Rate (ORR), defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to Response Evaluation Criteria for Solid Tumours (RECIST) v1.1.|Up to 12 months|ORR was assessed on the efficacy analysis set, consisting of all patients with measurable disease, PRCC confirmed by a central laboratory and have received at least 1 dose of AZD6094 (n = 84).|||Participants|||Count of Participants
1328395|NCT02127632|Secondary|Throat Pain According to Visual Analogue Scale|Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, 1 hr and 24 hr after the end of surgery according to Visual Analogue Scale. (range min. 0, max.10; >4 analgesia planned)|postoperative 1st and 24th hours||||point||Standard Deviation|Mean
1328396|NCT02127632|Secondary|Evaluation of Gastric Distention|To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)|Baseline||||units on a scale||Standard Deviation|Mean
1328397|NCT02127632|Primary|Mean Airway Pressures|"The measure is the mean airway pressure (cmH2O):~T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device"|At first and last 10 minutes of pneumoperitoneum||||cmH20||Full Range|Mean
1328398|NCT02127567|Secondary|Average Score for Completeness of Reporting of Essential Elements|Completeness of reporting scores calculated based on essential elements to report, on a scale from 0 to 10, 0 being the lowest and10 the highest|one time four hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328401|NCT02127567|Secondary|The Score for Completeness of Reporting for Interventions|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328402|NCT02127567|Secondary|The Score for Completeness of Reporting for Participants|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328403|NCT02127567|Secondary|The Score for Completeness of Reporting for Blinding|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328404|NCT02127567|Secondary|The Score for Completeness of Reporting for Randomization|The score for completeness of reporting (0-10) for the manuscript section randomization, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328405|NCT02127567|Primary|The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.|Completeness of reporting will be determined according to a grading rubric individualized to each study protocol, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
1328406|NCT02127372|Primary|Phase II - Radiographic Response|"The percentage of patients with a complete or partial response.~Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|After Cycle 6, approximately 18 weeks.||||percentage of participants||95% Confidence Interval|Number
1328407|NCT02127372|Secondary|Change in Gd-MRI Measurement|The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.|Day 7|Because the study was terminated prior to completion, correlative studies were not run.||||||
1328408|NCT02127372|Secondary|Phase 2: 1 Year Survival|Phase II: Percentage of patients alive 1 year from the start of protocol treatment.|1 year||||percentage of participants||95% Confidence Interval|Number
1328409|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.|||mg/m2|||Number
1328410|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of STI571|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.|||mg|||Number
1328411|NCT02127307|Primary|Relationship Between the Occurrence of Death and 123I-mIBG Uptake on Planar Scintigraphy With Heart to Mediastinum (H/M) Ratio of <1.60 vs H/M ≥1.60|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. H/M ratios were categorized as ‘Low’ and ‘High’ based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data, as reflected by the H/M ratio, for identifying HF participants at lower risk of death during 60 months of follow-up.|From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months|Efficacy population was 961 participants who received investigational medicinal product (IMP) and had a diagnostic 3 hour 50 minute planar image in MBG311 or MBG312. Here, 'n' signifies number of participants with available data for specified category.|||number of death or other adverse events|||Number
1328412|NCT02127281|Secondary|Knee Extension|Median knee extension (degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Inter-Quartile Range|Median
1328413|NCT02127281|Secondary|Hip Range of Motion|Median hip range of motion (extension, in degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Inter-Quartile Range|Median
1328414|NCT02127281|Secondary|VR-12 Questionnaire|Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively.|90 days postoperatively||||units on a scale||Standard Deviation|Mean
1328415|NCT02127281|Secondary|Hip Range of Motion (Flexion)|Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Standard Deviation|Mean
1328416|NCT02127281|Secondary|Timed-up-and-go Test|Median Timed-up-and-go test (seconds)|4 weeks postoperatively||||seconds||Inter-Quartile Range|Median
1328417|NCT02127281|Secondary|HOOS and KOOS Scores at 90 Days Postoperatively|Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.|90 days postoperative|The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups|||units on a scale||Inter-Quartile Range|Median
1328418|NCT02127281|Secondary|HOOS and KOOS Scores at 90 Days Postoperatively|Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.|90 days postoperative|The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups|||units on a scale||Standard Deviation|Mean
1328420|NCT02127281|Primary|Readmission Rates|Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision|Within 90 days after surgery|"80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat.~80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat"|||Participants|||Count of Participants
1328421|NCT02127281|Primary|Re-operation Rates|Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision|Within 90 days after surgery|"80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat.~80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat"|||Participants|||Count of Participants
1328422|NCT02127281|Primary|Number of Patients With Wound Complications|Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.|Within 90 days after surgery|"80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat.~80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat"|||participants|||Number
1328423|NCT02126839|Secondary|Summary of Participants With Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).~Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|6 Months|Safety Analysis set includes all participants who receive at least 1 dose of study drug. In this population, treatment is assigned based upon the treatment participants actually receive, regardless of the treatment to which they were randomized.|||participants|||Number
1328424|NCT02126839|Secondary|Baseline Adjusted Peak Expiratory Flow (PEF) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Serial PEF measurements were obtained via spirometry. PEF measures for purpose of serial PEF assessment (pre and postdose) were collected from the spirometer assessed PEF, utilizing the values from the efforts selected based on the highest of 3 acceptable FEV1 maneuvers.|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|Full analysis set|||Liters/min*hour||Standard Error|Least Squares Mean
1328425|NCT02126839|Primary|Baseline Adjusted Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Following measurement of the baseline FEV1 and dose administration on Days 1 and 22, FEV1 values (highest of 3 acceptable maneuvers) will be obtained at 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±10), 120 (±10), 240 (±10), and 360 (±10) minutes after the completion of dosing. Predicted FEV1 values were computed and adjusted for age, height, and gender according to Eigen et al (Eigen et al 2001) for participants 4 to 5 years of age and to Quanjer et al (Quanjer et al 1995) for participants aged 6 to 11 years using ATS criteria (American Thoracic Society/European Respiratory Society Statement 2007).|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|The full analysis set (FAS) includes all participants in the ITT population who receive at least 1 dose of study medication and have at least 1 postbaseline assessment of the primary endpoint.|||% predicted FEV1/hour||Standard Error|Least Squares Mean
1328426|NCT02126748|Secondary|Oxygen Saturation (SaO2)|oxygen saturation (SaO2) measured by pulse -oximetry|before, after and 1h after treatment|||||||
1328427|NCT02126748|Secondary|Heartrate||before, after and 1h after intervention|||||||
1328428|NCT02126748|Secondary|Wang Score||before treatment, immediately after treatment and 1h after treatment|||||||
1328429|NCT02126748|Primary|Length of Hospital Stay|Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)|6 days||||days||Standard Deviation|Mean
1328430|NCT02126670|Secondary|Irritation Score|Percentage of participants with moderate or severe overall irritation at end of treatment.|up to Day 57|Overall irritation|||percentage of participants|||Number
1328431|NCT02126670|Primary|Treatment Success at End of Study Visit|Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions|up to Day 57|Per protocol|||percentage of participants||95% Confidence Interval|Number
1328432|NCT02126319|Primary|Pca Related Intrusive Ideation|Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979). The full scale consists of two subscales, intrusive ideation and avoidant ideation but only the intrusive ideation subscale was used in the present study. The instrument has been used extensively in the cancer literature (Schwartz et al., 2002). Cronbach’s alpha for the intrusion subscale in the present study was 0.82. Values range from zero to 35, with higher values indicating higher level of intrusive ideation. Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.|Six months||||units on a scale||Standard Deviation|Mean
1328433|NCT02126319|Primary|Negative Expectations Regarding Pca Risk|Negative expectations related to Pca risk screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., “Screening may have a negative impact on my health insurance”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of five items). Cronbach’s alpha for the scale was 0.80. A higher score indicates more negative expectations.|Six months||||units on a scale||Standard Deviation|Mean
1328434|NCT02126319|Primary|Pca-related Positive Expectations|Positive expectations regarding the effects of screening were assessed using two items on a five-point scale (“Regular screening will ensure that I stay healthy” and “Regular screening will prolong my life”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of the two items). Cronbach’s alpha for the scale was 0.76. Higher score indicates more positive expectations.|six months||||units on a scale||Standard Deviation|Mean
1328435|NCT02126319|Primary|Pca Perceived Risk|Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., “Do you feel as though you are the kind of person who is likely to develop prostate cancer?”) or comparing themselves to other men at risk for Pca (e.g., “Given your ethnicity, what are your chance of getting prostate cancer?”) on a five-point scale (Lerman et al., 1996). Reported means are based on a scale from one to five (based on the average of the four items). Cronbach’s alpha for the scale was 0.83. A higher score indicates higher Pca perceived risk.|six months||||units on a scale||Standard Deviation|Mean
1328436|NCT02126319|Primary|Pca Risk-related Knowledge|Knowledge about Pca risk was measured using an eight item scale prepared for this study. It consisted of true/false items [e.g., “An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer”]. Correct responses received a value of one, whereas false responses received a zero. Values ranged between zero and eight. Higher score means better knowledge of risk and issues.|six months||||units on a scale||Standard Deviation|Mean
1328437|NCT02126319|Primary|Pca Related Intrusive Ideation|Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979). The full scale consists of two subscales, intrusive ideation and avoidant ideation. In this study only the intrusive ideation subscale was used. The instrument has been used extensively in the cancer literature (Schwartz et al., 2002). Values range from 0 to 35, with higher values indicating a higher level of intrusive ideation. Cronbach’s alpha for the intrusion subscale in the present study was 0.82. Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.|three weeks||||units on a scale||Standard Deviation|Mean
1328438|NCT02126319|Primary|Negative Expectations Regarding Pca Risk|Negative expectations related to Pca screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., “Screening may have a negative impact on my health insurance”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of five items). Cronbach’s alpha for the scale was 0.80. A higher score indicates more negative expectations.|three weeks||||units on a scale||Standard Deviation|Mean
1328439|NCT02126319|Primary|Pca-related Positive Expectations|Positive expectations regarding the effects of screening were assessed using two items on a five-point scale (“Regular screening will ensure that I stay healthy” and “Regular screening will prolong my life”). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of the two items). Cronbach’s alpha for the scale was 0.76. Higher score indicates more positive expectations.|three weeks||||units on a scale||Standard Deviation|Mean
1328440|NCT02126319|Primary|Pca Perceived Risk|Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., “Do you feel as though you are the kind of person who is likely to develop prostate cancer?”) or comparing themselves to other men at risk for Pca (e.g., “Given your ethnicity, what are your chance of getting prostate cancer?”) on a five-point scale (Lerman et al., 1996). Reported means are based on a scale from one to five (based on the average of the four items). Cronbach’s alpha for the scale was 0.83. A higher score indicates higher Pca perceived risk.|three weeks||||units on a scale||Standard Deviation|Mean
1328441|NCT02126319|Primary|Pca Risk-related Knowledge|Knowledge about Pca risk was measured using an eight item scale prepared for this study. It consisted of true/false items [e.g., “An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer”]. Correct responses received a value of one, whereas false responses received a zero. Values ranged between zero and eight. Higher score means better knowledge of risk and issues.|three weeks||||units on a scale||Standard Deviation|Mean
1328442|NCT02126306|Primary|Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol|"Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made.~Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included."|Total score from baseline compared with week 40.||||participants|||Number
1328443|NCT02125877|Secondary|Dererasirox Plasma Concentration|Blood samples were collected to assess deferasirox concentration. Dose-adjusted calculations are presented: (concentration/actual dose)*20 for participants on DFX-DT and (concentration/actual dose)*14 for participants on DFX-FCT.|Week 3, day 1, pre-dose (0 hour (h)) and 2 h post-dose; week 13, day 1, pre-dose (0 hour (h)) and 2 h post-dose; and week 21, day 1, pre-dose (0 hour (h)) and 2 h post-dose|The Pharmacokinetic analysis set for all participants was considered for this analysis, but only participants with non-missing values were included in the analysis.|||umol/L||Standard Deviation|Mean
1328444|NCT02125877|Secondary|Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)|Blood samples were collected to assess Tmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed|||hour||Full Range|Median
1328445|NCT02125877|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax)|Blood samples were collected to assess Cmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed|||umol/L||Standard Deviation|Mean
1328446|NCT02125877|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|Blood samples were collected to assess AUClast.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed.|||umol/L*h||Standard Deviation|Mean
1328447|NCT02125877|Secondary|Weekly Dose Violation Rate|The dose violation is defined as a dose either missed completely or not taken in accordance with the timing instruction (no later than 12:00 pm. The rate was calculated as [number of dose violations/drug exposure (days)] x 100.|weeks 1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||percent dose violation||Standard Deviation|Mean
1328448|NCT02125877|Secondary|Number of Participants With Weekly Average Compliance of Medication Consumption|A compliance questionnaire assessed whether the medication was taken. Weekly average compliance was calculated when there were at least four non-missing daily responses.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Participants|||Number
1328449|NCT02125877|Secondary|Weekly Average of Daily Scores of the Gastrointestinal (GI) Symptom Diary|The GI symptom diary consisted of 6 items, five which were scored using a 0 - 10 rating scale with item appropriate anchors to rate the symptom, for example, Pain in your belly: 0 = no pain and 10 = worst pain. The GI diary summary score was created using the 10 point response scale for the 5 items. The GI symptom daily diary had a minimum score of 0 and a maximum score of 50. The weekly average score for the 7 days was calculated for each individual item and the GI summary score was created from these weekly averages. Higher scores indicated worse symptoms. A meaningful difference between two treatment arms was determined to be 0.3 point.|weeks -1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||score on a scale||Standard Deviation|Mean
1328450|NCT02125877|Secondary|Palatability Questionnaire Score|"The palatability questionnaire consisted of 4 items. The first item measured the taste and aftertaste of the medication and were scored a on a 5-point response scale. The second item offered an additional response option of no aftertaste. The last 2 items referred to whether the medication was taken, i.e. swallowed or vomited, and how the participant perceived the amount of medication to be taken. The palatability summary score was calculated using a scoring matrix from items 1, 3 and 4 scores and the score ranges from 0 - 11. Higher scores indicated the best palatability. A meaningful difference between two treatment arms was determined to be 1 point."|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||score on a scale||Standard Deviation|Mean
1328451|NCT02125877|Secondary|Mean Domain Scores of the Modified Satisfaction With Iron Chelation Therapy (Modified SICT)|The modified SICT consisted of 13 items that represent 3 domains: adherence, satisfaction and concerns. The adherence domain consisted of 7 items, 6 which were measured using a 5-point response scale and was calculated by summing the 6 items. The score range from 6 to 30 and higher scores indicated worse adherence. The satisfaction domain consisted of 3 items, 2 which were measured using a 5-point response scale and was calculated by summing the 2 items. The score range from 2 to 10 and higher scores indicated worse satisfaction. The concerns domain consisted of 3 items to address any concerns or worries with his/her medication. All 3 items were measured on a 5-point response scale and were calculated by summing the 3 items. The score range from 3 to 15 and higher scores indicated fewer concerns. For all three domains, the meaningful difference between two treatment arms was determined to be 1 point.|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||score on a scale||Standard Deviation|Mean
1328452|NCT02125877|Secondary|Frequency of Selected Gastro-intestinal (GI) Adverse Events|The percentage of participants with any GI adverse event, diarrhea, constipation, nausea, vomiting, abdominal pain was assessed.|28 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
1328453|NCT02125877|Primary|Overall Safety as Measured by Changes in Laboratory Values From Baseline|The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.|baseline (BL), 30 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
1328454|NCT02125877|Primary|Overall Safety as Measured by Frequency of Adverse Events|The percentage of participants with adverse events, serious adverse events and deaths was assessed.|28 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
1328455|NCT02125838|Primary|Asses to Mean Pressure|mean pressures within the times below (cmH20) T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|during procedure||||cmH20||Standard Deviation|Mean
1328456|NCT02125838|Primary|Asses to Peak Pressure|peak pressure (cmH20) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|intraoperative period||||cmH20||Standard Deviation|Mean
1328457|NCT02125838|Secondary|Incidence of Post-operative Sore Throat|Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr and 24 hr after the end of surgery.|Baseline|||||||
1328458|NCT02125838|Secondary|Haemodynamic Response to Insertion of Airway Device|Systolic blood pressure and heart rate at two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal .|Baseline|||||||
1328459|NCT02125838|Secondary|Ease of Orogastric Tube Placement Classification|Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.|Baseline|Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.|||participants|||Number
1328460|NCT02125838|Secondary|Evaluation of Gastric Distention|To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)|Baseline||||units on a scale||Standard Deviation|Mean
1328461|NCT02125838|Secondary|Quality of View According to Surgeon by Rate Scale|"Quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device by Rate Scale.~Grade of quality of view were evaluated between 1-4 points (1-poor to 4-excellent)"|intraoperative period||||percentage of participants|||Number
1328462|NCT02125838|Primary|Asses to Ventilation Parameters|tidal volume (ml) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|intraoperative period||||ml||Standard Deviation|Mean
1328463|NCT02125734|Secondary|Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.|The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. One patient with missing data for this analysis.|||Participants|||Number
1328464|NCT02125734|Secondary|Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.|Patient preference after experiencing both treatments. The patient’s preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Three patients were missing data for the patient preference analysis.|||Participants|||Number
1328465|NCT02125734|Primary|Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation|Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.|week 4|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period|||Liters||95% Confidence Interval|Least Squares Mean
1328466|NCT02125604|Primary|Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS|Percentage of days with GI events as reported on MAGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The ST categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||percentage of days||Standard Deviation|Mean
1328467|NCT02125604|Secondary|Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events||Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate.|||percentage of participants|||Number
1328468|NCT02125604|Secondary|Percentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events|Dose reductions are defined as participants who take any dimethyl fumarate 120 mg or 0 mg since initiation of dimethyl fumarate 240 mg.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate.|||percentage of participants|||Number
1328469|NCT02125604|Secondary|Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category|Symptomatic therapies were classified into 10 categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (eg, Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (NSAID; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in 'All therapies'.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||days||Standard Deviation|Mean
1328478|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Vital Signs|Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements, all measured 6 hours post-dose. Study personnel used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
1328470|NCT02125604|Secondary|Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category|Symptomatic therapies were classified into 10 main categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (includes Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (non-steroidal anti-inflammatory drug [NSAID]; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). Participants may have taken > 1 symptomatic therapy but were counted only once for the 'All therapies' summary.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.|||participants|||Number
1328471|NCT02125604|Secondary|Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12|The cumulative percentage of dimethyl fumarate-treated participants with relapsing-remitting multiple sclerosis who required symptomatic therapy up to Week 4, Week 8, and Week 12 were estimated using the Kaplan-Meier method.|Week 4, Week 8, Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.|||percentage of participants|||Number
1328472|NCT02125604|Primary|Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS|The percentage of days with GI events as reported on MOGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The symptomatic therapy (ST) categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||percentage of days||Standard Deviation|Mean
1328473|NCT02125604|Primary|Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS|The MAGISS is a questionnaire about the overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) following drug administration (acute symptoms). MAGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||units on a scale||Standard Deviation|Mean
1328474|NCT02125604|Primary|Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS|The MOGISS is a questionnaire about overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. MOGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||units on a scale||Standard Deviation|Mean
1328475|NCT02125604|Primary|Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)|The MAGISS is a questionnaire in which participants reported overall acute gastrointestinal-related events, (especially symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) for each 10 hours after the AM and PM doses of study drug. Participants who rated the intensity of gastrointestinal-related events reported on MAGISS, included the duration of the gastrointestinal-related events and each symptomatic therapy used in the eDiary are presented.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.|||Participants|||Number
1328476|NCT02125604|Primary|Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about the severity of overall gastrointestinal-related events, including specifically symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence for 24 hours before the AM dose. Participants who rated the intensity of symptoms reported on the MOGISS and included each symptomatic therapy used in the eDiary are presented.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.|||Participants|||Number
1328477|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results|Subjects underwent a standard 12-lead ECG 6 hours post-dose. The investigator assessed if the ECG tracing was normal or abnormal; if abnormal, the investigator made a determination of whether or not the abnormality was clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
1328497|NCT02124603|Secondary|Antibiotic Susceptibility|Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.|At least 14 days before surgery|Percentage of isolates susceptibility to antibiotics|||percentage of susceptible isolates|Participants||Number
1328479|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Laboratory Results|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters, all measured 6 hours post-dose. All clinical laboratory assays were performed according to the laboratory’s normal procedures. Reference ranges were supplied by the laboratory and were used to assess the clinical laboratory data for clinical significance and out-of-range pathological changes. The investigator assessed out-of-range clinical laboratory values for clinical significance and indicated whether or not the values were clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
1328480|NCT02125292|Secondary|Number of Participants Who Experienced an Adverse Event|Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.|4 days|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
1328481|NCT02125292|Primary|Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis|"The participants were asked to answer Yes or No to the following question: Would you be willing to take medicine this way on a regular basis if necessary? The number of participants who answered Yes is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
1328482|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement The aftertaste (if present) was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
1328483|NCT02125292|Primary|Number of Participants Who Detected an Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered Yes or No to the following question: Was there an aftertaste? The number of participants who answered Yes is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
1328484|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine|"A taste assessment was completed immediately after investigational product was administered to assess the subject’s taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement The taste was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
1328485|NCT02124863|Primary|Number of Refluxes|Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV|during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.|All patients receiving IPV were their own controls|||number of refluxes||Standard Deviation|Mean
1328486|NCT02124811|Secondary|Inflammatory Markers|"Markers of inflammation at baseline are presented by high or low baseline C-Reactive Protein levels. Increased levels of inflammatory markers indicate that the body is experiencing infection, trauma, or other illness. Normal ranges for inflammatory markers can vary by lab and patient characteristics; general normal ranges are presented below.~Tumor necrosis factor (TNF) alpha is a cytokine associated with systemic inflammation and the normal range for TNF alpha is <5.6 picograms per milliliter (pg/ml).~Interleukin 1 (IL-1) beta is a pro-inflammatory cytokine implicated in pain, inflammation and autoimmune conditions. The normal range for IL-1 beta is <3.9 pg/ml.~Interleukin 6 (IL-6) is secreted by T cells and macrophages stimulating an immune response during infection and after trauma. The normal range for IL-6 is < 5 pg/ml.~Interleukin 10 (IL-10) is a cytokine impacting immunoregulation and inflammation. The normal range for IL-10 is <2 pg/ml."|Baseline|Participants completing the baseline visit are included in this analysis.|||pg/ml||Standard Deviation|Mean
1328487|NCT02124811|Secondary|Global Assessment of Functioning (GAF) Score|Social, occupational, and psychological functioning was to be assessed using the Global Assessment of Functioning (GAF) in the initial study protocol.|Baseline, Week 12|A protocol amendment removed the GAF outcome measure as this information was determined to be non-essential. To reduce participant burden, data were not collected for this outcome measure.||||||
1328488|NCT02124811|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Score|Perceived quality of life and general well being was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item questionnaire asking participants to rate how satisfied they have been with heath related qualities on a 5-point scale where 1 = very poor and 5 = very good. Raw scores of the Q-LES-Q-SF range from 14 to 70 and higher scores indicate higher life enjoyment and satisfaction.|Baseline, Week 12|Participants who completed the study are included in this analysis|||units on a scale||Standard Deviation|Mean
1328498|NCT02124603|Primary|Positive Culture in Subjects Scheduled for Cataract Surgery|Number of participants with positive culture at the screening visit|At least 14 days before surgery|Number of participants with positive culture|||subjects|||Number
1328499|NCT02124460|Post-Hoc|Parent Very Satisfied With Information he/She Received About Resources in the Community|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received community resources were included in this analysis.|||Participants|||Count of Participants
1328489|NCT02124811|Primary|General Psychopathology Score of the Positive and Negative Syndrome Scale (PANSS)|General symptoms of schizophrenia/schizoaffective disorder were measured using the general psychopathology subscale of the Positive and Negative Syndrome Scale (PANSS). The PANSS is scored by the clinician-researcher after an interview with the patient and it is the most commonly used measure for assessing the symptoms of schizophrenia. Sixteen items measure general psychopathology symptoms of somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Items are scored on a scale of 1 to 7 where 1 means the symptom is absent and 7 means the symptom is extreme. Total scores for this subscale can range from 16 to 112 where higher scores indicate more severe symptoms. A reduction in the score indicates an improvement in symptom severity.|Baseline, Week 12||||units on a scale||Standard Deviation|Mean
1328490|NCT02124811|Primary|Brief Assessment of Cognition in Schizophrenia (BACS) Score|The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcomes in patients with schizophrenia (verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive function). BACS takes less than 35 minutes to complete and was administered on an electronic tablet for this study. The composite score is a T-score that averages the standardized scale scores of each of the six tests. The composite T-score has a mean of 50 and a standard deviation of 10. Scores below 50 indicate lower than average cognition while scores above 50 indicate higher than average cognition. A prior study found that the BACS mean composite score for schizophrenia patients was 25.96 while healthy controls had a mean score of 47.00.|Baseline, Week 12|This analysis includes participants who completed the study and who completed the BACS. One participant in the high CRP did not complete this test at either time point.|||units on a scale||Standard Deviation|Mean
1328491|NCT02124811|Primary|Negative Subscale Score of the Positive and Negative Syndrome Scale (PANSS)|Negative symptoms (representing a loss of normal functions) of schizophrenia/schizoaffective disorder were measured with the negative subscale of the Positive and Negative Syndrome Scale (PANSS). The PANSS is scored by the clinician-researcher after an interview with the patient and it is the most commonly used measure for assessing the symptoms of schizophrenia. Seven items measure the negative symptoms of blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity & flow of conversation, and stereotyped thinking. The items are scored on a scale of 1 to 7 where 1 means the symptom is absent and 7 means the symptom is extreme. The total summed score for the negative subscale ranges between 7 and 49 where higher scores indicate more severe symptoms. A reduction in the score indicates an improvement in symptom severity.|Baseline, Week 12|Participants who completed the study are included in this analysis.|||units on a scale||Standard Deviation|Mean
1328492|NCT02124811|Primary|Positive Subscale Score of the Positive and Negative Syndrome Scale (PANSS)|Positive symptoms (representing unusual thought content) of schizophrenia/schizoaffective disorder were measured with the positive subscale of the Positive and Negative Syndrome Scale (PANSS). The PANSS is scored by the clinician-researcher after an interview with the patient and it is the most commonly used measure for assessing the symptoms of schizophrenia. Seven items measure the positive symptoms of delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The items are scored on a scale of 1 to 7 where 1 means the symptom is absent and 7 means the symptom is extreme. The total summed score for the positive subscale ranges between 7 and 49 where higher scores indicate more severe symptoms. A reduction in the score indicates an improvement in symptom severity.|Baseline, Week 12|Participants who completed the study are included in this analysis.|||units on a scale||Standard Deviation|Mean
1328493|NCT02124798|Secondary|Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic)|Assessment was performed for suitability of the auto injector for self-administration of belimumab by participant with SLE outside the clinic setting. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections outside of the clinic without assistance were included.|Weeks 3, 5, 6, and 7 (Outside clinic)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
1328494|NCT02124798|Secondary|Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic)|The main objective was to assess the suitability of the auto injector for self-administration of belimumab by participants with SLE. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.|Weeks 4 and 8 (Inside clinic)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
1328495|NCT02124798|Primary|Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic)|The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.|Weeks 1 and 2 (Inside clinic)|The intention-to-treat (ITT) population was defined as all participants who were enrolled and treated with at least 1 dose of belimumab. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
1328496|NCT02124603|Secondary|Eradication Rate|Number of participants having positive culture at the screening visit with bacterial eradication before surgery|Day of surgery|Number of participants with positive culture at the screening visit|||partecipants|||Number
1328572|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity|Safety determined by the severity of treatment emergent adverse events.|1 day post last consumption||||Percentage of subjects|||Number
1328500|NCT02124460|Post-Hoc|Received Text Messages or Emails From Connect 4 Health|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.|||Participants|||Count of Participants
1328501|NCT02124460|Post-Hoc|Received Information From Connect 4 Health About Resources in the Community|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.|||Participants|||Count of Participants
1328502|NCT02124460|Post-Hoc|Parent Very Satisfied With Content of Connect 4 Health Text Messages or Emails.|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received text messages were included in this analysis.|||Participants|||Count of Participants
1328503|NCT02124460|Post-Hoc|Increased Satisfaction With Care at Harvard Vanguard Medical Associates (HVMA)|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.|||Participants|||Count of Participants
1328504|NCT02124460|Secondary|Change in Consumption of Sugar-sweetened Beverages and Juice|Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.|baseline and 1 year||||times/day||95% Confidence Interval|Mean
1328505|NCT02124460|Secondary|Change in Fruit and Vegetable Consumption|Number of times the child consumed of vegetables and fruits yesterday|baseline and 1 year||||times/day||95% Confidence Interval|Mean
1328506|NCT02124460|Secondary|Change in Physical Activity|In the past week, how many days the child was physically active for a total of at least 60 minutes per day.|baseline and 1 year||||days/week||95% Confidence Interval|Mean
1328507|NCT02124460|Secondary|Change in Sleep|Average hours/day spent sleeping|baseline and 1 year||||hours/day||95% Confidence Interval|Mean
1328508|NCT02124460|Secondary|Change in Screen Time|Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.|baseline and one year||||hours/day||95% Confidence Interval|Mean
1328509|NCT02124460|Primary|Change in Parent Resource Empowerment|The five items in the scale assessed parents’ perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach’s α for this score was 0.87.|Baseline to one-year follow-up||||units on a scale||95% Confidence Interval|Mean
1328510|NCT02124460|Primary|Change in Quality of Life|The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0–100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.|baseline and one year||||units on a scale||95% Confidence Interval|Mean
1328511|NCT02124460|Primary|Change in BMI z Score|Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.|baseline and one year||||BMI z score units||95% Confidence Interval|Mean
1328512|NCT02124304|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. Participants were asked to rate the intensity of an exercise on a scale from 0 to 10, 0 being no resistance and 10 being the maximum resistance.|12 exercises during one 1 hour session||||units on a scale, ranging from 0 to 10||Full Range|Mean
1328513|NCT02124304|Primary|Percent of Peak Activation (%PA)|8 muscles during 12 exercises were analyzed in 30 subjects, totaling 2880 data points. At the beginning of the study, peak activation (PA) was assessed for each muscle during full flexion-extension, used as a reference exercise. For each subject, the EMG signals of the muscles during the 12 exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the PA for each muscle was determined, it was compared to the PA of the reference exercise for the respective muscle group, and expressed as a percent of the peak activation (%PA). In some cases the %PA is greater than 100%. This is possible as the PA was assessed during a full flexion-extension movement. During an exercise some muscles generated greater PA and therefore when the calculations were performed the %PA was greater than 100%. Due to the extensive amount of data, we have provided the Left Cervical Paraspinals %PA results for each exercise.|One 1 hour session||||Percentage of Peak Activation (%PA)||Full Range|Mean
1328533|NCT02124044|Primary|The Percentage of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.|12 weeks after stop of treatment|Subjects who received treatment drugs per arm as listed in the Outcome Measure Description|||Percentage of subjects|||Number
1328573|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence|Safety determined by the incidence of treatment emergent adverse events.|1 day post last consumption||||% of patients with adverse events|||Number
1328514|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1|"Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, number of participants analyzed signifies participants with valid and determinate assay results for specified strain at both the specified blood draws."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
1328515|NCT02124161|Secondary|Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers|"Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than <1:10 and after Vaccination 1 (post-vaccination 1) HAI titer >=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer >=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1328516|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, number of participants analyzed signifies total participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed."|Immediately before Vaccination 2, 1 month after Vaccination 2|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
1328517|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
1328518|NCT02124161|Secondary|Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)|"Percentage of participants achieving predefined OPA antibody titer >= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results to the specified serotype."|1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1328519|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 168 to 196 days after Vaccination 2|Safety population included all participants who received at least 1 dose of vaccination.|||percentage of participants|||Number
1328520|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."|||percentage of participants|||Number
1328521|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."|||percentage of participants|||Number
1328522|NCT02124161|Primary|Percentage of Participants With Treatment-­Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 1|Safety population included all participants who received at least 1 dose of vaccination.|||percentage of participants|||Number
1328523|NCT02124161|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)|"HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies participants with a determinate HAI titer to the given strain."|1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1328524|NCT02124161|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes|"Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with a determinate OPA titer to the given serotype."|1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1328525|NCT02124122|Primary|Mean Daily Temperature|Mean of body temperatures recorded on study days listed, averaged across all participants at all time points|Study days 1-5, 8,12, 15, 18, 28, and 36||||Degrees Celsius||Standard Deviation|Mean
1328526|NCT02124122|Primary|Number of Participants With Positive Blood Culture for L Reuteri||Participants are followed an average of 36 days||||Participants|||Count of Participants
1328527|NCT02124083|Primary|Number of Participants With Tolerabilty of 400 mg Vorinostat in Niemann-Pick Disease, Type C1|The number of Niemann-Pick Disease, type C1 patients completing 3 month 400 mg phase|3 months|All participants completing 200 mg phase and starting 400 mg phase|||Participants|||Number
1328528|NCT02124083|Primary|Number of Participants With Tolerabilty of 200 mg Vorinostat in Niemann-Pick Disease, Type C1|The number of Niemann-Pick Disease, type C1 patients completing 3 month 200 mg phase|3 months|All participants who started study|||Participants|||Number
1328529|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum LGALS3|Serum concentration of LGALS3 (galectin-3). Galectin-3 is a carbohydrate-binding lectin whose expression is associated with inflammatory cells including macrophages, neutrophils, and mast cells. LGALS3 normal range = 1.4-5.3 ng/ml.|Baseline|All participants who started study|||ng/mL||Standard Deviation|Mean
1328530|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum LGALS3|Serum concentration of LGALS3 (galectin-3). Galectin-3 is a carbohydrate-binding lectin whose expression is associated with inflammatory cells including macrophages, neutrophils, and mast cells. LGALS3 normal range = 1.4-5.3 ng/ml.|6 months|All participants completing both 200 and 400 mg phases|||ng/mL||Standard Deviation|Mean
1328531|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum Cathepsin D|Serum concentration of Cathepsin D. Cathepsin D is an aspartyl protease involved in protein catabolism and tissue remodeling. Cathepsin D normal range = 220-515 ng/ml.|Baseline|All participants who started study|||ng/mL||Standard Deviation|Mean
1328532|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum Cathepsin D|Serum concentration of Cathepsin D. Cathepsin D is an aspartyl protease involved in protein catabolism and tissue remodeling. Cathepsin D normal range = 220-515 ng/ml.|6 months|All participants completing both 200 and 400 mg phases|||ng/mL||Standard Deviation|Mean
1328534|NCT02123966|Secondary|Change Pre-to-post Treatment in Oral Health Impact Profile Assessment|Oral health related quality of life will be assessed before and after topical sirolimus therapy using the 14-item Oral Health Impact Profile instrument that measures subject's perceptions of the impact of oral conditions on their well-being.|Pre treatment and after the 28 day (4 weeks) cycle of treatment|Data was not accessible and therefore the analysis was not conducted.||||||
1328535|NCT02123966|Primary|Percentage of Participants With a Subjective Sensitivity Score Response|The sensitivity score is one question on a self-reported assessment tool from the NIH consensus documents. The question asks: “Your mouth sensitivity at its WORST” with a score 0-10, 10 being the worst. Response was defined as a 3 point reduction in sensitivity score from pre-to-post treatment.|Pre treatment and after the 28 day (4 weeks) cycle of treatment|The analysis population is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
1328536|NCT02123849|Secondary|Change in Buccal Cells Via Karyometric Analysis||Baseline to up to one week post-intervention|Data were not collected||||||
1328537|NCT02123849|Secondary|Whole-genome Gene Expression - Number of Canonical Pathways Differentially Expressed|Gene set enrichment analysis was performed on the MSigDB canonical pathways with the intent to discover differentially expressed genes after aspirin intervention.|Baseline to 12 weeks|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||canonical pathway|||Number
1328538|NCT02123849|Secondary|Persistence of the Change in the Smoking-related Gene Expression Signature Score in the Nasal Epithelium One Week Off Agent Intervention|Change in nasal smoking-related gene expression signature score from baseline to 1 week post-intervention was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 1 week post-intervention|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
1328539|NCT02123849|Secondary|Persistence of the Change in the Lung Cancer-related Gene Expression Signature Score in the Nasal Epithelium One Week Off Agent Intervention|Change in the lung cancer-related gene expression signature score from baseline to one week off agent intervention was compared between the two study arms. Prior research showed that higher scores were observed in lung cancer cases than healthy controls. A decreased score implicated a favorable intervention effect. There is no minimum or maximum score.|Baseline to 1 week post-intervention|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
1328540|NCT02123849|Secondary|Changes in Lung Cancer-related Gene Expression Signature Score in the Nasal Epithelium|Change in lung cancer-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that the score was higher in lung cancer cases than healthy controls. A decreased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 12 weeks (End-of-Intervention)|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
1328541|NCT02123849|Secondary|Gender Effect on Smoking-related Gene Expression Signature Score|Change in nasal smoking-related gene expression signature score was compared between male and female participants. The gender comparison was not stratified by arm because of the small sample size. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 12 weeks (End-of-Intervention)|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
1328542|NCT02123849|Secondary|Number of Participants Experiencing Possibly/Probably/Definitely-related Adverse Events||Up to 2 weeks post-treatment||||Participants|||Count of Participants
1328543|NCT02123849|Secondary|Changes in Urine Prostaglandin E2 Metabolite (PGE-M) Levels|Urinary PGE-M was used as a biomarker of cyclooxygenase (COX) mediated arachidonic acid metabolism. Decreased PGE-M implicated inhibition of COX mediated pathway.|Baseline to 12 weeks (End-of-Intervention)||||ng/mg creatinine||Standard Deviation|Mean
1328544|NCT02123849|Secondary|Changes in Urine Leukotriene E4 (LTE(4)) Levels|Urinary LTE(4) was used as a biomarker 5-lipoxygenase (5-LOX) mediated arachidonic acid metabolism. Decreased LTE4 implicated inhibition of the 5-LOX mediated pathway.|Baseline to 12 weeks (End-of-Intervention)||||pg/mg creatinine||Standard Deviation|Mean
1328545|NCT02123849|Primary|Changes in Smoking-related Gene Expression Signature Score in Nasal Epithelium|Change in nasal smoking-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 12 weeks (End-of-Intervention)|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
1328546|NCT02123745|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.|After each participant has been infiltrated, an expected average of 1 hour||||participants|||Number
1328547|NCT02123745|Secondary|Infiltrated Volume When Yellow Notification Issued|The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour||||mL|Participants|Standard Deviation|Mean
1328548|NCT02123745|Secondary|Infiltrated Volume When Red Notification Issued|The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour||||mL|Participants|Standard Deviation|Mean
1328549|NCT02123745|Secondary|Yellow Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour||||percentage of infiltrations|Participants|95% Confidence Interval|Number
1328550|NCT02123745|Primary|Red Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour||||percentage of infiltrations|Participants|95% Confidence Interval|Number
1328551|NCT02123472|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Microgram per milliliter(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1328552|NCT02123472|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hours||Standard Deviation|Median
1328553|NCT02123472|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||hour*microgram per milliliter (h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1328554|NCT02123459|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hours||Standard Deviation|Median
1328555|NCT02123459|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1328556|NCT02123459|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hours*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1328557|NCT02123446|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable PK data.|||hours||Standard Deviation|Median
1328558|NCT02123446|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
1328559|NCT02123446|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hour*microgram per milliliter(h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1328560|NCT02123329|Secondary|Health Related Quality of Life|Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters|6 month|Unfortunately patients didnt return at 6 months to fill the QOL questionnaire this is why we dont have data to report on this measure||||||
1328561|NCT02123329|Primary|Objective Smoking Abstinence|Smoking abstinence as objectively verified by the CO exhaled test at 12 months|12 months||||Participants|||Count of Participants
1328562|NCT02123329|Primary|Self-reported Continuous Abstinence|Defined as having smoked no cigarettes since quit day at 12 months|12 months||||participants|||Number
1328563|NCT02123329|Primary|Self-reported 30-day Point Prevalence Abstinence|Defined as having smoked no cigarettes in the last 30 days|12 months||||Participants|||Count of Participants
1328564|NCT02123329|Primary|Self-reported 7-day Point Prevalence Abstinence|Defined as having smoked no cigarettes for the previous 7 days|12 months||||Participants|||Count of Participants
1328565|NCT02123329|Primary|Self-reported Continuous Abstinence|Defined as having smoked no cigarettes since quit day|6 months||||Participants|||Count of Participants
1328566|NCT02123329|Primary|Self-reported 30-day Point Prevalence Abstinence|Defined as having smoked no cigarettes in the last 30 days|6 months||||Participants|||Count of Participants
1328567|NCT02123329|Primary|Self-reported 7-day Point Prevalence Abstinence|Defined as having smoked no cigarettes for the previous 7 days|6 months||||Participants|||Count of Participants
1328568|NCT02123329|Primary|Self-reported Continuous Abstinence at 3 Months|Self-reported continuous abstinence defined as having smoked no cigarettes since quit day|3 months||||Participants|||Count of Participants
1328569|NCT02123329|Primary|Self-reported 30 Day Smoking Abstinence|Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days|3 months||||Participants|||Count of Participants
1328570|NCT02123329|Primary|Self-reported 7-day Point Prevalence Abstinence|Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days|3 months||||Participants|||Count of Participants
1328571|NCT02123017|Secondary|Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant|Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable|1 day post last consumption||||units on a VAS scale||Standard Deviation|Mean
1328574|NCT02123017|Primary|Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.|Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.|10-14 hours post last consumption||||units on a scale||Standard Deviation|Mean
1328575|NCT02122796|Secondary|Change in Ability to Cope Post Intervention|Change in ability to cope on a single question 11-point Numeric Rating Scale (NRS) where 0 equals absence of an ability to cope and 10 equals complete ability to cope. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Coping Day 1 - Pre-Coping Day 1). . A higher score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
1328576|NCT02122796|Secondary|Change in Nausea Post Intervention|Change in nausea on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no nausea and 10 equals most severe nausea. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Nausea Day 1 - Pre-Nausea Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
1328577|NCT02122796|Secondary|Change in Anxiety Post Intervention|Change in anxiety on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no anxiety and 10 equals most severe anxiety. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Anxiety Day 1 - Pre-Anxiety Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
1328578|NCT02122796|Secondary|Change in Pain Post Intervention|Change in pain on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no pain and 10 equals most severe pain. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Pain Day 1 - Pre-Pain Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
1328579|NCT02122796|Primary|Number of Patients Eligible Compared to the Number Approached and Enrolled|Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.|One year|A total of 252 women were scheduled to receive a unilateral or bilateral mastectomy during the study period. Of those, 61 were eligible for study participation, and there were 30 women who provided consent and were randomized.|||Participants|||Count of Participants
1328580|NCT02122549|Primary|Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.|The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).|24 hours or longer|Subjects who wore the HWD 1000 for a minimum of 24 hours.|||percentage of time worn||Standard Deviation|Mean
1328581|NCT02122445|Secondary|Perceived Exertion|The amount of perceived exertion was reported for each of the 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), by 20 subjects, totaling 240 data points. This was measured using the TheraBand(R) Resistance Intensity Scale for Exercise (RISE Scale). Participants were asked to rate their perceived exertion on a scale of 0 to 10, 0 being no resistance and 10 being maximum resistance. The results of the 20 subjects were averaged for each exercise at each time point.|Perceived Exertion||||units on a scale, from 0 to 10||Full Range|Mean
1328582|NCT02122445|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.|% Maximal Voluntary Isometric Contracion (%MVIC)||||% of Max Voluntary Isometric Contraction||Full Range|Mean
1328583|NCT02122406|Primary|Hospital Anxiety and Depression Scale (HADS)|Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.|1 day of enrollement||||participants|||Number
1328584|NCT02122146|Secondary|Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328599|NCT02122146|Secondary|Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3]|AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328585|NCT02122146|Secondary|Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]|Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328586|NCT02122146|Secondary|Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3]|Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328587|NCT02122146|Secondary|Trop-2 Expression Levels on Archived Tissue [Part 2 & 3]|Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression|Day 1|No participant was analyzed due to study termination||||||
1328588|NCT02122146|Secondary|Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328589|NCT02122146|Secondary|Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3]|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328590|NCT02122146|Secondary|Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3]|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328591|NCT02122146|Secondary|Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328592|NCT02122146|Secondary|Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328593|NCT02122146|Secondary|Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3]|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328594|NCT02122146|Secondary|Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328595|NCT02122146|Secondary|Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328596|NCT02122146|Secondary|Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3]|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328597|NCT02122146|Secondary|Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3]|AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328598|NCT02122146|Secondary|Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3]|AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328600|NCT02122146|Secondary|Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Cmax of unconjugated payload PF-06380101 was observed directly from data|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328601|NCT02122146|Secondary|Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3]|Cmax of total antibody PF-06479118 was observed directly from data|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328602|NCT02122146|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3]|Cmax of PF-06664178 was observed directly from data|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
1328603|NCT02122146|Secondary|Overall Number of Participants With Objective Tumor Response [Part 2 & 3]|Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In)|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|No participant was analyzed due to study termination||||||
1328604|NCT02122146|Secondary|Overall Number of Participants With Objective Tumor Response[Part 1]|Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|Of all enrolled 31 patients who were treated, 1 participant from the 0.60mg/kg cohort and 1 participant from the 4.20mg/kg cohort did not have post-dose tumor evaluations for they were discontinued form study prior to having disease assessment .|||participants|||Number
1328605|NCT02122146|Secondary|Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3]|Number of participants with the presence of anti-PF-06664178 antibodies|Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment|No participant was analyzed due to study termination||||||
1328606|NCT02122146|Secondary|Overall Incidence of Anti-PF-06664178-Antibodies[Part 1]|Number of participants with the presence of anti-PF-06664178 antibodies|Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment|All enrolled participants who started treatment|||participants|||Number
1328607|NCT02122146|Secondary|Number of Participants With Laboratory Abnormalities[Part 1]|Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.|Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)|All enrolled participants who started treatment.|||participants|||Number
1328608|NCT02122146|Secondary|Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1]|An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.|From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)|All enrolled participants who started treatment|||participants|||Number
1328609|NCT02122146|Primary|Number of Participants With Laboratory Abnormalities [Part 2 & 3]|Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.|On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)|No participant was analyzed due to study termination||||||
1328610|NCT02122146|Primary|Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]|An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.|Day 1 up to Day 21|No participant was analyzed due to study termination||||||
1328643|NCT02121795|Secondary|Percent of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis||Week 96|||||||
1328611|NCT02122146|Primary|First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)|Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.|Day 1 up to Day 21|All enrolled participants who started treatment. One of participants that experienced DLTs in PF-06664178 4.80mg/kg group was a late DLT that occurred at the beginning of Cycle 2 and was classified as a late DLT.|||participants|||Number
1328612|NCT02121860|Primary|Cmax|Maximum concentration (Cmax)|48 Hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328613|NCT02121860|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose||||RLU||Inter-Quartile Range|Median
1328614|NCT02121860|Secondary|Levels of cCK18/M30|Caspase-cleaved cytokeratin levels (cCK18M30)|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose||||U/L||Inter-Quartile Range|Median
1328615|NCT02121860|Primary|AUC|Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);|48 Hours|The analyzed sample size was 36 subjects: 12 subjects with mild, and 8 subjects each with moderate and severe hepatic impairment, and with normal hepatic function.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328616|NCT02121847|Secondary|Change From Baseline in Conjunctival Redness in the Worse Eye|Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
1328617|NCT02121847|Secondary|Change From Baseline in the Interblink Interval in the Worse Eye|The interblink interval measures the time (seconds) between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Seconds||Standard Deviation|Mean
1328618|NCT02121847|Secondary|Change From Baseline in Tear Film Break-up Time in the Worse Eye|TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Seconds||Standard Deviation|Mean
1328619|NCT02121847|Secondary|Change From Baseline in Ocular Discomfort on a 4-point Scale|Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6||||Scores on a Scale||Standard Deviation|Mean
1328620|NCT02121847|Secondary|Change From Baseline in OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
1328621|NCT02121847|Primary|Change From Baseline in Font Size|The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Size||Standard Deviation|Mean
1328622|NCT02121847|Primary|Change From Baseline in Words Read Incorrectly|The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Words||Standard Deviation|Mean
1328623|NCT02121847|Primary|Change From Baseline in Reading Rate|Reading speed is assessed as the number of words read correctly in 2 minutes.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Words/Minute||Standard Deviation|Mean
1328624|NCT02121847|Primary|Change From Baseline in Watching TV on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
1328625|NCT02121847|Primary|Change From Baseline in Working With a Computer or Bank Machine on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
1328626|NCT02121847|Primary|Change From Baseline in Driving at Night on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
1328627|NCT02121847|Primary|Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
1328628|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye|Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
1328629|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye|Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
1328630|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye|Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
1328631|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye|Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
1328632|NCT02121834|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258||Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs|All participants who received at least one dose of study drug and had measurable Cmax PK concentrations after dosing.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1328633|NCT02121834|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258||Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs|All participants who received at least one dose of study drug and had measurable AUC PK concentrations after dosing.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1328634|NCT02121834|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline to Study Completion (Up to 14 Weeks)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1328635|NCT02121808|Other Pre-specified|Vital Signs|Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described.|At the end of a 5 minutes pre-oxygenation period|||||||
1328636|NCT02121808|Secondary|Patient's Comfort|Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described.|At the end of a 5 minutes pre-oxygenation period|||||||
1328637|NCT02121808|Secondary|Respiratory Mechanics|Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described.|At the end of a 5 minutes pre-oxygenation period|||||||
1328638|NCT02121808|Secondary|Diaphragmatic Amplitude.|Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described.|After a 5 minutes pre-oxygenation period|||||||
1328639|NCT02121808|Primary|Functional Residual Capacity|Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.|After a 5 minutes pre-oxygenation period||||ml||Standard Deviation|Mean
1328640|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|||||||
1328641|NCT02121795|Secondary|Percent Change From Baseline in Hip and Spine BMD at Week 96||Baseline; Week 96|||||||
1328642|NCT02121795|Secondary|Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis||Week 96|||||||
1328646|NCT02121795|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.|||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
1328647|NCT02121795|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Hip DXA Analysis Set (participants who were randomized and received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.|||percentage of change in hip BMD (g/cm^2)||Standard Deviation|Mean
1328648|NCT02121795|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis||Week 48|Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug|||Percentage of participants|||Number
1328649|NCT02121535|Secondary|AUC0-∞ for Hydrochlorothiazide|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328650|NCT02121535|Primary|AUC0-tz for Hydrochlorothiazide|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328651|NCT02121535|Primary|Cmax for Hydrochlorothiazide|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328652|NCT02121535|Primary|Cmax for Amlodipine|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328653|NCT02121535|Primary|AUC0-tz for Amlodipine|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328654|NCT02121535|Secondary|AUC0-∞ for Amlodipine|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328655|NCT02121535|Secondary|AUC0-∞ for Telmisartan|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328656|NCT02121535|Primary|Cmax for Telmisartan|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328657|NCT02121535|Primary|Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|"Pharmacokinetic set (PKS):~included all subjects in the TS who had evaluable pharmacokinetic (PK) variables for both test drug and reference drugs. Subjects who had an important protocol violation (PV) for relevant PK evaluation were excluded from the PKS."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328658|NCT02121522|Secondary|Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29|Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing.|Baseline and day 29|Treated set (OC). Observed Case (OC): This method analysed only available data that were observed while patients were on treatment, ie., missing data were not imputed.|||mm²||Standard Deviation|Mean
1328659|NCT02121522|Primary|Change From Baseline in CRT as Measured by SD-OCT on Day 29|Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.|Baseline (day 1) and day 29|Treated set (WOCF). Missing values are imputed by the worst observation carried forward (WOCF) measurement (including baseline).|||μm||Standard Deviation|Mean
1328660|NCT02121509|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328671|NCT02121483|Primary|Cmax|Maximum measured concentration in plasma (Cmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1328661|NCT02121509|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1328662|NCT02121509|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1328663|NCT02121509|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328664|NCT02121509|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1328665|NCT02121509|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS1500 Fast and PKS1500 Fed, included all treated subjects in Part 1 and Part 2, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1328666|NCT02121483|Secondary|Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake|"Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1).~For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as fixed effect and ‘MDG at baseline’ as continuous covariate.~Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with plasma glucose profile data on both visits|||mg/dL||Standard Error|Mean
1328667|NCT02121483|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake|"Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake.~For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘FPG at baseline’ as continuous covariate.~Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with FPG data on both visits|||mg/dL||Standard Error|Mean
1328668|NCT02121483|Secondary|Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake|"Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake.~For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including ‘treatment’ as a fixed effect and ‘UGE at baseline’ and ‘FPG at baseline’ as continuous covariates. Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with UGE data on both visits|||g/24h||Standard Error|Mean
1328669|NCT02121483|Primary|t1/2|Terminal half-life in plasma (t1/2).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||hours||Geometric Coefficient of Variation|Geometric Mean
1328670|NCT02121483|Primary|Tmax|Maximum measured concentration in plasma (tmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||hours||Full Range|Median
1328758|NCT02120794|Secondary|Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups|Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9%|Baseline and 1 year after screening||||percentage||Standard Deviation|Mean
1328672|NCT02121483|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1328673|NCT02121483|Primary|AUC0-inf|Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1328674|NCT02121418|Secondary|Response Rate|Rate of Complete Response or Complete Response with Incomplete Count Recovery|Up to 2 years||||participants|||Number
1328675|NCT02121418|Primary|Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS|Compared to historical data of a completed Southwestern Oncology Group (SWOG) trial of azacitidine and gemtuzumab ozogamicin.|At 6 months||||participants|||Number
1328676|NCT02121210|Secondary|Serum Sarilumab Concentration|Trough Concentration (Ctrough).|Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30|Analysis was performed on pharmacokinetic (PK) population consisted of all randomized population actually received at least one or partial dose of IMP, with at least one post-dose, non-missing serum sarilumab concentration. Number of participants analyzed=participants with serum sarilumab concentration assessment at specified time-points.|||ng/mL||Standard Deviation|Mean
1328677|NCT02121210|Primary|Percentage of Participants With Incidence of Antidrug Antibodies (ADA)|ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.|From Baseline to Week 30 [End of study (EOS)]|Analysis was performed on immunogenicity population included all randomized participants who received at least one dose of sarilumab with at least one post-dose, evaluable ADA sample.|||Percentage of participants|||Number
1328678|NCT02121067|Secondary|Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.|Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.|6 months postpartum|Of the 50 participants who enrolled and had an LNG-IUS placed at 2 weeks postpartum, only 43 were available at 6 months postpartum to provide data for expulsion.|||Participants|||Count of Participants
1328679|NCT02121067|Primary|Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.|Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?|Day 14-20 postpartum||||Participants|||Count of Participants
1328680|NCT02121067|Primary|Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.|A dichotomous, yes/no answer to the following question “Would you recommend Mirena placement at two-weeks postpartum to a friend?”|6 months postpartum|Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome.|||Participants|||Count of Participants
1328681|NCT02121041|Primary|24 Hour Blood Pressure Average at the End of 4 Month Participation.||Participants will be on study average of 4 months.||||mm Hg||Standard Deviation|Mean
1328682|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – I Would Recommend This Product to Another Parent.|Questions were answered immediately post-treatment by participant’s caregiver. Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328683|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328684|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328685|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328759|NCT02120794|Secondary|Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups|Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7%|Baseline and 1 year after screening||||percentage||Standard Deviation|Mean
1328686|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328687|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328688|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328689|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328690|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328691|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328692|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328693|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328694|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328695|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328696|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328697|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328760|NCT02120794|Primary|Overall Mean Change in A1C|The overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.|Baseline and 1 year after screening||||percentage||95% Confidence Interval|Mean
1328698|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328699|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328700|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328701|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328702|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328703|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328704|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328705|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328706|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328707|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328708|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328709|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328761|NCT02120664|Secondary|Variability of PET Images in Young Healthy Control Subjects.|Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|Young healthy controls enrolled in the study|||SUVr||Standard Deviation|Mean
1328710|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328711|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328712|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328713|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328714|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328715|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328716|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328717|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328718|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328719|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328720|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328721|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328796|NCT02119936|Secondary|Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV)|The investigators will measure HF-HRV in 1-minute segments during HRVB, and will test whether coherence score, as recorded by the HRVB device, correlates with HF-HRV.|Baseline to in-patient follow-up (5 to 7 days in between)|HF-HRV data was not collected||||||
1328722|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328723|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328724|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328725|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328726|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328727|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328728|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328729|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328730|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Feels Soft|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328731|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Healthy|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328732|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment – Overall, my Baby’s Skin Looks Smooth|Questions were answered immediately post-treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328733|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328734|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328735|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328736|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328737|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328738|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Feels Soft|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328739|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Healthy|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328740|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment – Overall, my Baby’s Skin Looks Smooth|Questions were answered before treatment by participant’s caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant’s skin, and affected area’s look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from ‘I don’t have an opinion’ to ‘strongly disagree.’|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
1328741|NCT02120833|Secondary|Corneometer Measurement on Day 14 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
1328742|NCT02120833|Secondary|Corneometer Measurement on Day 7 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
1328743|NCT02120833|Secondary|Corneometer Measurement on Day 3 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
1328744|NCT02120833|Secondary|Corneometer Measurement on Day 2 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
1328745|NCT02120833|Secondary|Corneometer Measurement on Day 1 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
1328746|NCT02120833|Secondary|Corneometer Measurement on Day 0 – Post-Treatment - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3.|Baseline to Post -Treatment on Day 0|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
1328747|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328748|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328749|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328750|NCT02120833|Secondary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328751|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328752|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328753|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328754|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328755|NCT02120833|Primary|Investigator’s Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator’s Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328756|NCT02120833|Primary|Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1328757|NCT02120794|Secondary|Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups|Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c > 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c > 9%|Baseline and 1 year after screening||||percentage||Standard Deviation|Mean
1334069|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5|||Percent predicted||Standard Deviation|Mean
1328762|NCT02120664|Secondary|Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid|Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer’s disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete the florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.|||centiloid||Standard Deviation|Mean
1328763|NCT02120664|Primary|Florbetapir SUVr Conversion to Centiloid Units|Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer’s disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete a florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.|||centiloid||Standard Deviation|Mean
1328764|NCT02120625|Secondary|Number of Participants With Serious and Non-Serious Adverse Events||Up to 6 weeks||||Participants|||Count of Participants
1328765|NCT02120625|Primary|EMG Evidence of Lesion of the Targeted Medial Branches|EMG evidence of lesion of the targeted medial branches (Percentage of positive lesions)|3-6 weeks post radiofrequency ablation||||percentage of lesions|Lesions|95% Confidence Interval|Number
1328766|NCT02120625|Primary|Volume of Lesions Were Recorded by the Reading Radiologists|Volume of lesions were recorded by the reading radiologists, including proximity to medial branches|7 days||||cubic millimeters||95% Confidence Interval|Mean
1328767|NCT02120625|Primary|Percentage of Patients With Magnetic Resonance Imaging (MRI) Evidence of Tissue Ablation/Edema at Targeted Lumbar Medial Branches|Documentation of Magnetic Resonance Imaging (MRI) evidence of tissue ablation/edema at targeted lumbar medial branches as they course around the superior articular process and transverse process juncture of the vertebrae|7 days|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production. EMG of lumbar multifidi for medial branch lesion documentation was carried out and percent of successful lesions recorded and analyzed.|||percentage of participants|||Number
1328768|NCT02120443|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.|24 hours|Three participants were excluded for significant protocol deviations.|||IV sites||95% Confidence Interval|Number
1328769|NCT02120443|Secondary|Normal Tissue Yellow Notification Rate|The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method.|24 hours|Three participants were excluded due to significant protocol deviations.|||yellow notifications per day||95% Confidence Interval|Mean
1328770|NCT02120443|Primary|Normal Tissue Red Notification Rate|The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method.|24 hours|Three subjects were excluded from analysis due to significant protocol deviations.|||red notifications per day||95% Confidence Interval|Mean
1328771|NCT02120417|Primary|Percentage of Participants Achieving Overall Survival|Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.|Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants||95% Confidence Interval|Number
1328772|NCT02120417|Secondary|Percentage of Participants Achieving Clinical Benefit Rate|Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
1328797|NCT02119936|Secondary|Change in State-Trait Anxiety Inventory From Baseline to In-patient Follow up (5-7 Days).|State-trait anxiety scores range from 40-80 with higher scores indicative of greater anxiety|Baseline to in-patient follow-up (5 to 7 days in between)|No in-patient follow up was completed due to patients moving off antepartum unit prior to meeting the 5-7 day in-patient criteria||||||
1328798|NCT02119936|Primary|Feasibility of Using HRVB Among Hospitalized Pregnant Women|The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.|Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)||||Participants|||Count of Participants
1328773|NCT02120417|Secondary|Duration of Response (DOR)|The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||months||80% Confidence Interval|Median
1328774|NCT02120417|Secondary|Percentage of Participants Achieving Objective Response Rate|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
1328775|NCT02120417|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.|Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||months||95% Confidence Interval|Median
1328776|NCT02120417|Primary|Median Survival|Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.|Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||months||95% Confidence Interval|Median
1328777|NCT02120417|Primary|Overall Survival (OS)|Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.|Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||Participants|||Count of Participants
1328778|NCT02120300|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)||Baseline; Weeks 12, 24, and Posttreatment Week 12|Participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1328779|NCT02120300|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)||Weeks 4, 8, 12, 16, 20, and 24|Only the participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
1328780|NCT02120300|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1328781|NCT02120300|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1328782|NCT02120300|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1328783|NCT02120300|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1328784|NCT02120300|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1328785|NCT02120300|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1328799|NCT02119871|Secondary|Duration of the De-airing Procedure|Duration of the de-airing procedure counted in minutes.|Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||minutes||Inter-Quartile Range|Median
1328859|NCT02118961|Secondary|Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 10 EU/mL.|28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||percentage of Participants||95% Confidence Interval|Number
1328786|NCT02120027|Secondary|Sustained Analysis of Response for Abdominal Pain AND Stool Consistency Over First 24-week Double-blind Treatment Period|Weekly response for abdominal pain intensity AND stool consistency over the first 24 weeks of treatment in at least 50% of the weeks of treatment (12 out of 24 weeks) with at least 2 weeks of response in the last 4 weeks of treatment (week 21 to 24). The patient will be considered a weekly responder as defined for the primary endpoint.|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
1328787|NCT02120027|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over the First 24 Weeks of Treatment in at Least 50% of the Weeks (12 Out of 24)|"The patient was considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved.~Weekly e-diary assessment of IBS degree-of-relief of overall on signs or symptoms over the last 7 days was collected using a balanced 7-point Likert scale with 1= Completely relieved/improved, 2= Considerably relieved/improved, 3=Somewhat relieved/improved, 4= Unchanged, 5= Somewhat worse, 6=Considerably worse, 7= As bad as I can imagine."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
1328788|NCT02120027|Secondary|Weekly Response for Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient was considered a weekly stool consistency responder if she met the following criterion:~Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
1328789|NCT02120027|Secondary|Weekly Response for Abdominal Pain Intensity Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:~Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
1328790|NCT02120027|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:~Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline (patients reported their worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain);~Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline (patients reported their stool consistency response using the Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea)."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
1328791|NCT02120001|Secondary|Microbiological Colonization of Distal Airways|Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a specimen from the distal airways immediately before extubation.|At extubation (An expected average of 7 days)||||Log colony form unit (CFU)/ mL||Standard Deviation|Mean
1328792|NCT02120001|Primary|Endotracheal Tube Colonization|Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).|At extubation (an expected average of 7 days)||||Log colony form unit (CFU)/ mL||Standard Deviation|Mean
1328793|NCT02119936|Secondary|Change in Warwick Edinburgh Mental Well Being Scale From Baseline to In-patient Follow up (5-7 Days).|The Warwick Edinburgh Mental Well Being Scale is a 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.|Baseline to in-patient follow-up (5 to 7 days in between)|All participants were discharged from the antepartum unit prior to 5-7 days in-patient so these study data were not collected.||||||
1328794|NCT02119936|Secondary|Change in Linear Analog Self-Assessment (LASA) From Baseline to In-patient Follow up (5-7 Days).|The Linear Analog Self-Assessment (LASA) form measures patient quality-of-life. Scores range from 6-30 with higher scores indicative of greater well-being.|Baseline to in-patient follow-up (5 to 7 days in between)|All participants were discharged from antepartum unit prior to 5-7 days in-patient so these study data were not collected.||||||
1328795|NCT02119936|Secondary|Correlation of HRVB Feedback With Varying Levels of Clinical Depression and Anxiety|The investigators will stratify our population based on the depression screen used at the baseline visit. These groups will include those with severe, moderate, or lack of depression. The investigators will then compare these groups to the finds from the surveys on maternal mood and the difference noticed among the groups due to the HRVB tools.|Baseline to in-patient follow-up (5 to 7 days in between)|All participants were discharged from the antepartum unit prior to 5-7 days in-patient so these data were not collected.||||||
1328800|NCT02119871|Primary|Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.|7-10 minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||Participants|||Count of Participants
1328801|NCT02119871|Primary|Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.|3-6 minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||Participants|||Count of Participants
1328802|NCT02119871|Primary|Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.|0-3 minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||Participants|||Count of Participants
1328803|NCT02119871|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and the left middle cerebral artery will be reported.|Period of ten minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||gaseous cerebral microemboli||Inter-Quartile Range|Median
1328804|NCT02119871|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and the left middle cerebral artery will be reported.|Time from cardiac ejection to finished de-airing, an average on 5-10 minutes|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||gaseous cerebral microemboli||Inter-Quartile Range|Median
1328805|NCT02119871|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and the left middle cerebral artery will be reported.|Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent (LVAV) in order to evaluate:1. the impact on de-airing of unilateral open pleura compared to bilateral open pleurae, and 2. the impact on de-airing of a right superior pulmonary vein vent compared to LVAV.|||gaseous cerebral microemboli||Inter-Quartile Range|Median
1328806|NCT02119676|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event (AE) during the study that began or worsened on or after the date of first dose of investigational product.|Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2.|Safety Population consists of all enrolled participants that received at least one dose of study drug.|||percentage of participants|||Number
1328807|NCT02119676|Secondary|Percentage of Participants Achieving Disease Control|Disease control as measured by the percentage of participants whose best response was complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||percentage of participants||95% Confidence Interval|Number
1328808|NCT02119676|Secondary|Duration of Response|Duration of response is defined as the time from response (CR/PR) until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|No data displayed because outcome measure has not been analyzed. Duration of response analyses was not done since there were no responders in Substudy 1 and very few responders in Substudy 2 at data cutoff (27JAN2016 for Substudy 1 and 11Feb2016 for Substudy 2). Duration of response analysis was not done in both substudies.||||||
1328809|NCT02119676|Secondary|Overall Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions without new lesion; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions, non-target lesion not progressed, and no new lesion; Progressive Disease=20% increase in sum of longest diameter of target lesions, or non-target lesion progression, or identification of new lesion; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants randomized.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||percentage of responders||95% Confidence Interval|Number
1328810|NCT02119676|Secondary|Progression Free Survival (PFS)|Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||months||95% Confidence Interval|Median
1328811|NCT02119676|Primary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.|Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||months||95% Confidence Interval|Median
1328812|NCT02119663|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).|||Participants|||Count of Participants
1328813|NCT02119663|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
1328814|NCT02119663|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumours RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by RECIST at any post baseline visit. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
1328815|NCT02119663|Secondary|Percentage of Participants Achieving Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants||95% Confidence Interval|Median
1328816|NCT02119663|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
1328817|NCT02119663|Primary|Overall Survival (OS)|Overall survival is reported here based on the number of deaths from randomization until the data cut-off.|Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||Participants|||Count of Participants
1328818|NCT02119650|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring (or worsening of any pre-existing) after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.|||Participants|||Count of Participants
1328819|NCT02119650|Secondary|Duration of Response|For objective responders, the duration of response is defined as the difference of the end of response and the start of response. The start of a response was the first visit where the subject achieves PR or better based on RECIST v1.1 criteria. The end of response was the first visit after PD based on RECIST v1.1 criteria.|From the start of response to the end of response; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||weeks||80% Confidence Interval|Median
1328820|NCT02119650|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||Participants|||Count of Participants
1328821|NCT02119650|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum Longest Diameter (LD) recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions or increase in disease burden for subjects with only nonmeasurable disease.|Randomization to disease progression, or death due to any cause if sooner; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||Months||95% Confidence Interval|Median
1328822|NCT02119650|Primary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis were censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.|Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||months||80% Confidence Interval|Median
1328823|NCT02119325|Secondary|Tmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
1328824|NCT02119325|Secondary|AUC for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU*min/mL||Standard Deviation|Mean
1328825|NCT02119325|Secondary|Cmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU/mL||Standard Deviation|Mean
1328826|NCT02119325|Secondary|Tmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
1328827|NCT02119325|Secondary|AUC for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU*min/mL||Standard Deviation|Mean
1328828|NCT02119325|Secondary|Cmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU/mL||Standard Deviation|Mean
1328857|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies||28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||EU/mL||95% Confidence Interval|Geometric Mean
1328858|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies||28-42 days after vaccination||||IU/mL||95% Confidence Interval|Geometric Mean
1328829|NCT02119325|Secondary|Tmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
1328830|NCT02119325|Secondary|AUC for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole*min/L||Standard Deviation|Mean
1328831|NCT02119325|Secondary|Cmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole/L||Standard Deviation|Mean
1328832|NCT02119325|Secondary|Tmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
1328833|NCT02119325|Secondary|AUC for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole*min/L||Standard Deviation|Mean
1328834|NCT02119325|Secondary|Cmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole/L||Standard Deviation|Mean
1328835|NCT02119325|Secondary|Tmax for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
1328836|NCT02119325|Secondary|AUC for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg*min/dL||Standard Deviation|Mean
1328837|NCT02119325|Secondary|Cmax for Triglyceride in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
1328838|NCT02119325|Secondary|Tmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
1328839|NCT02119325|Secondary|AUC for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg*min/dL||Standard Deviation|Mean
1328860|NCT02118961|Secondary|Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.|28-42 days after vaccination||||percentage of Participants||95% Confidence Interval|Number
1328840|NCT02119325|Secondary|Cmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
1328841|NCT02119325|Primary|Cmax for Triglyceride in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
1328842|NCT02119325|Primary|Cmax for Glucose in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
1328843|NCT02119299|Secondary|Device Compliance|Device compliance is calculated as 100*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).|Week 16||||% of eating episodes with device use||Standard Deviation|Mean
1328844|NCT02119299|Secondary|Percentage Total Body Loss and Treatment Compliance Correlation|The measured relationship between SMART device usage and total weight loss.|16 weeks|Per Protocol Population|||Pearson correlation|||Number
1328845|NCT02119299|Secondary|Proportion of Subjects Achieving ≥12% EWL||16 weeks|Per Protocol Population|||Participants|||Count of Participants
1328846|NCT02119299|Secondary|Proportion of Subjects Achieving ≥4% Weight Loss||16 weeks|Per Protocol Population|||Participants|||Count of Participants
1328847|NCT02119299|Secondary|Mean Absolute Weight Loss (kg)||16 weeks|Per Protocol Population|||Body weight (kg)||Standard Deviation|Mean
1328848|NCT02119299|Secondary|Mean Percentage Excess Weight Loss (EWL)||16 weeks|Per Protocol Population|||percentage of excess weight loss||Standard Deviation|Mean
1328849|NCT02119299|Primary|Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0||16 weeks|Per Protocol population|||% TBL||Standard Deviation|Mean
1328850|NCT02119299|Primary|Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0||16 weeks|Per Protocol Population|||Participants|||Count of Participants
1328851|NCT02119286|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1328852|NCT02119286|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1328853|NCT02119104|Primary|Number of Participants With Adverse Reactions|An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.|The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.|The safety analysis population comprised of participants who had received Prevenar 13 at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
1328854|NCT02118961|Secondary|Percentage of Participants With Adverse Events||28-42 days following vaccination||||percentage of participants|||Number
1328855|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||titer ratio||95% Confidence Interval|Geometric Mean
1328856|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination||||titer ratio||95% Confidence Interval|Geometric Mean
1334070|NCT02029521|Secondary|Forced Vital Capacity|Forced vital capacity percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5|||percent predicted||Standard Deviation|Mean
1328861|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies|Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.|pre-vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||percentage of Participants||95% Confidence Interval|Number
1328862|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies|Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.|pre-vaccination and 28-42 days after vaccination||||percentage of Participants||95% Confidence Interval|Number
1328863|NCT02118896|Post-Hoc|Efficacy Failure|Efficacy failure was defined as BCAR, graft loss, death, or an unknown outcome at the end of the study period. Start, event and censor times for the Kaplan-Meier analyses of efficacy failure were (Event time: onset of first episode of BCAR, graft loss, or death after study start, Censor Time: day of withdrawal (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study). No Kaplan-Meier estimates for PMR-EC-1210 due to the short subject participation period and the low number of subjects|Up to 5.75 years ((69 months (phase II) and 33 months (phase III)).|The study analysis population for this endpoint consisted of participants with efficacy failure.|||participants with efficacy failure|||Number
1328864|NCT02118896|Secondary|Number of Participants With Adverse Events|An AE was defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have a causal relationship with treatment. An AE was, therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the study drug, whether or not related to the study drug. Causally-related is defined as a highly probably, probably, possible, not assessable or missing relationship as assessed by the investigator. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life threatening: did not refer to event which hypothetically might have caused death if more severe); resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; required inpatient hospitalization/led to prolongation of hospitalization (treatment/observation/examination caused by AE was considered serious); other medically important events.|From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).|FAS population.|||participants with adverse events|||Number
1328865|NCT02118896|Secondary|Time to First BCAR Episode|The time to first acute rejection episode was defined as the number of days from day 1 (defined as the day of study enrollment) to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.|Up to 1344 days (3.75 years).|The study analysis population for this endpoint consisted of subjects with biopsy confimed acute rejection.|||days||Standard Deviation|Mean
1328866|NCT02118896|Secondary|Biopsy-confirmed Acute Rejection (BCAR) Episodes|FAS population. Evaluation of biopsy specimens performed by local histopathologist following “Histological Grading of Biopsies for Rejection” using grading relevant to type of organ allograft. Spontaneously resolving AR defined as episode not treated with new/increased corticosteroid medication, antibodies/any other medication and resolved irrespective of any MR4/MMF/azathioprine dose changes; corticosteroid sensitive AR was an episode which was treated with new/increased corticosteroid medication only and resolved, irrespective of any MR4, MMF or azathioprine dose changes; corticosteroid resistant AR was an episode which did not resolve following treatment with corticosteroids, if it was not treated with corticosteroids first but only with antibodies, it was included in this category; corticosteroid resistant AR episodes were further classified into episodes which resolved with further treatment and those which did not respond to further treatment/were ongoing at EOS/withdrawal.|Up to 6 years.|FAS population.|||participants with with BCAR episodes|||Number
1328867|NCT02118896|Primary|Graft Survival|Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood’s formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).|Study analysis population for this primary endpoint consisted of the FAS.|||survival probability||95% Confidence Interval|Number
1328868|NCT02118896|Primary|Participant Survival|Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood’s formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years (66 months (phase II) and 24 months (phase III)).|The population for analysis was the Full Analysis Set (FAS) which included all subjects who received at least one dose of study drug, MR4, while participating in one of the phase II Pharmacokinetics (PK) or phase III studies and at least one dose of MR4 during this study.|||survival probability||95% Confidence Interval|Number
1328869|NCT02118831|Secondary|Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)|Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).|baseline and month 4||||pg/mL||95% Confidence Interval|Mean
1328870|NCT02118831|Primary|Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses|Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.|Up to 4 months||||nM||Standard Deviation|Mean
1328911|NCT02118441|Secondary|Number of Attempts|An attempt was defined as a new purposeful penetration of the skin with the needle (i.e., following complete withdrawal of the needle from the skin).|up to 5 minutes||||number of attempts||Inter-Quartile Range|Median
1328871|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 36|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 36|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1328872|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 29|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 29|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1328873|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 22|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. In this outcome, percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 22|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed N signifies those participants who were analyzed in this outcome measure."|||percentage of participants|||Number
1328874|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 15|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1= mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 15|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were analyzed in this outcome measure."|||percentage of participants|||Number
1328875|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 8|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 8|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1328876|NCT02118792|Other Pre-specified|Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score at Day 29|The DFI was a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It was completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question was scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score was the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1328877|NCT02118792|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1328895|NCT02118766|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position. Clinical significance of change from baseline value was determined by investigator.|Baseline, Day 29|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
1328878|NCT02118792|Other Pre-specified|Change From Baseline in Children’s Dermatology Life Quality Index (CDLQI) Score at Day 29|The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children’s (aged 2-15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the children’s life; 2-6 = small effect on the children’s life; 7-12 = moderate effect on the children’s life; 13-18 = very large effect on the children’s life; 19-30 = extremely large effect on the children’s life. Higher scores indicate more impact on quality of life of children.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1328879|NCT02118792|Other Pre-specified|Time to Improvement in Pruritus|Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.|Baseline (Day 1) up to Day 29|"ITT population included all participants who were randomized and received study drug. Here, N'' signifies those participants who were evaluable for this outcome measure."|||days||95% Confidence Interval|Median
1328880|NCT02118792|Secondary|Change From Baseline in Signs of Atopic Dermatitis at Day 29|Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.|Baseline, Day 29|ITT population included all participants who were randomized and received study drug. Here, 'n' signifies those participants who were evaluable at specific time point for each arm.|||units on a scale||Standard Deviation|Mean
1328881|NCT02118792|Secondary|Time to Achieve Treatment Success Based on Investigator’s Static Global Assessment (ISGA)|Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.|Baseline up to Day 29|ITT population included all participants who were randomized and received study drug.|||days||95% Confidence Interval|Median
1328882|NCT02118792|Secondary|Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.|Day 29|ITT population included all participants who were randomized and received study drug.|||percentage of participants|||Number
1328883|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Baseline|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Baseline (Day 1)|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1328884|NCT02118792|Primary|Number of Participants With Clinically Significant Laboratory Values|Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Bilirubin, Blood Urea Nitrogen, Glucose, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Erythrocytes, Potassium, Protein, Sodium. Clinically significant laboratory abnormalities were defined as abnormal laboratory test values that have clinical manifestations or require medical intervention, as per investigator’s discretion.|Baseline up to Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
1328885|NCT02118792|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position and after the participant had been calmly sitting or lying face up for a minimum of 5 minutes. Clinical significance of change from baseline value was determined by investigator.|Baseline (Day 1), Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
1328886|NCT02118792|Primary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8|ECG parameters that were analyzed: PR interval, QRS interval, QT interval and corrected QT interval based on Fridericia’s formula (QTcF). Clinical significance of change from baseline in ECG findings was determined by investigator.|Baseline, Day 8|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
1328887|NCT02118792|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study, that were absent before treatment or that worsened relative to pre-treatment state.|AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
1328888|NCT02118792|Primary|Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29|ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.|Day 29|ITT population included all participants who were randomized and received study drug.|||percentage of participants|||Number
1328889|NCT02118766|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant’s quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant’s life; 2-6 = small effect on the participant’s life; 7-12 = moderate effect on the participant’s life; 13-18 = very large effect on the participant’s life; 19-30 = extremely large effect on the participant’s life. Higher scores indicate more impact on quality of life of participants.|Baseline, Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1328890|NCT02118766|Other Pre-specified|Time to Improvement in Pruritus|Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.|Baseline up to Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, 'N' signifies those participants who were evaluable for this measure.|||days||95% Confidence Interval|Median
1328891|NCT02118766|Secondary|Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29|Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.|Baseline, Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1328892|NCT02118766|Secondary|Time to Achieve Treatment Success Based on Investigator’s Static Global Assessment (ISGA)|Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.|Baseline (Day 1) up to Day 29|Intent to treat population included all randomized participants who received the study drug.|||days||95% Confidence Interval|Median
1328893|NCT02118766|Secondary|Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.|Day 29|Intent to treat population included all randomized participants who received the study drug.|||percentage of participants|||Number
1328894|NCT02118766|Primary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29|Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Blood Urea Nitrogen, Creatinine, Hematocrit, Hemoglobin, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Red blood cell count, White blood cell count, Total bilirubin and Glucose (nonfasting), Potassium, Total Protein, and Sodium. Clinical significance of change from baseline value was determined by investigator.|Baseline, Day 29|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
1328910|NCT02118441|Secondary|Number of Re-directions|A re-direct was defined as the needle being purposefully withdrawn at least 5 mm and re-directed (but not removed from the skin entirely).|up to 5 minutes||||number of re-directs||Inter-Quartile Range|Median
1328896|NCT02118766|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.|AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
1328897|NCT02118766|Primary|Percentage of Participants Who Achieved Treatment Success Based on Investigator’s Static Global Assessment (ISGA) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.|Day 29|Intent to treat population included all randomized participants who received the study drug.|||percentage of participants|||Number
1328898|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)|Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.|Up to 72 weeks|Predictive values of previous virological response could not be analyzed as the SVR24 rate was based on one participant.||||||
1328899|NCT02118597|Secondary|Predictive Value of HCV Disease Characteristics|HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.|Screening (before Week 1)|Predictive values of HCV disease characteristics could not be analyzed as the SVR24 rate was based on one participant.||||||
1328900|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Liver Fibrosis|The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of sub-categories of liver fibrosis could not be analyzed as the SVR24 rate was based on one participant.||||||
1328901|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate|Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of participant demographics could not be analyzed as the SVR24 rate was based on one participant.||||||
1328902|NCT02118597|Secondary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 72 weeks|ITT population included all enrolled participants.|||participants|||Number
1328903|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation|Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.|||participants|||Number
1328904|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation Due to Futility|Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.|||participants|||Number
1328905|NCT02118597|Secondary|Number of Participants With Virological Relapse|Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.|Week 49 up to Week 72|ITT population included all enrolled participants.|||participants|||Number
1328906|NCT02118597|Secondary|Number of Participants With Virological Breakthrough|Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.|Up to Week 48|ITT population included all enrolled participants.|||participants|||Number
1328907|NCT02118597|Secondary|Percentage of Participants With Virological Response|Virological response is defined as HCV RNA <15 IU/mL.|Weeks 4, 8, 12, and 24|Intent to treat (ITT) population included all enrolled participants. Here, 'n' indicated number of participants with virological response data at evaluated time points.|||percentage of participants|||Number
1328908|NCT02118597|Primary|Sustained Virological Response 24 (SVR24) Rate|The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.|24 weeks after end of treatment (EOT) at Week 72|Due to the early termination of the study follow-up of the vast majority of the participants was not possible and data were not collected. Therefore, results for this outcome measure are based on one participant.|||percentage of participants|||Number
1328909|NCT02118441|Secondary|Complication Rate (Hematoma)|A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization|up to 5 minutes||||percentage of participants|||Number
1330832|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS)||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1328912|NCT02118441|Primary|Time to Successful Radial Arterial Catheterization|The time to successful radial arterial catheterization was defined as time zero to time of placement. Time zero for the DP group began when the anesthesiologist’s fingers were placed on the patient with the purpose of palpating the artery. Time zero for the US group began when the US transducer was first placed on the patient’s skin for the purpose of identifying the radial artery. Time to placement was defined as the interval from time zero until the time at which an arterial tracing was viewed on the monitor.|up to 5 minutes||||seconds||Inter-Quartile Range|Median
1328913|NCT02117934|Primary|Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response|Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B|Week 28|Per-Protocol Diabetes Population:Randomized subjects with type 2 diabetes mellitus (clinical diagnosis of T2DM taking at least oral or non-insulin injectable hypoglycemic agent and/or insulin) who received all study injections, had no major protocol deviations, and had anti-HBs levels obtained within the study visit window at Week 28.|||Percentage of participants||95% Confidence Interval|Number
1328914|NCT02117934|Primary|Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest|The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor’s office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.|Week 56|Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data|||percentage of participants|||Number
1328915|NCT02117687|Secondary|Study Product Use|The number of times the study product is administered per day is recorded.|Day 8, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Number of Times/Day||Standard Deviation|Mean
1328916|NCT02117687|Secondary|Conjunctival Hyperaemia in the Study Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
1328917|NCT02117687|Secondary|Change From Baseline in Conjunctival Staining in the Study Eye|The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
1328918|NCT02117687|Secondary|Change From Baseline in Corneal Staining in the Study Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
1328919|NCT02117687|Secondary|Work Productivity and Activity Impairment Questionnaire Score|The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, who did not adhere to a pre-defined list of protocol violation criteria, and who had data for this data point|||Scores on a Scale||Standard Deviation|Mean
1328920|NCT02117687|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Seconds||Standard Deviation|Mean
1328921|NCT02117687|Secondary|Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale|Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).|Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
1328922|NCT02117687|Secondary|Subject Assessment of Treatment Acceptability on a 5-Point Scale|Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).|Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
1329482|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The weights of 41 adult patients receiving intranasal placebo|1 day||||kg|||Number
1328923|NCT02117687|Secondary|Subject Global Assessment of Treatment Efficacy on a 5-Point Scale|Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
1328924|NCT02117687|Secondary|Subject Assessment of Dry Eye Symptoms on a 5-Point Scale|Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
1328925|NCT02117687|Secondary|Change From Baseline in the Schirmer Test in the Study Eye|The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Millimeters (mm)/5 Minutes||Standard Deviation|Mean
1328926|NCT02117687|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. Scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement and a positive number change from baseline represents a worsening.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
1328927|NCT02117687|Secondary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
1328928|NCT02117687|Primary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
1328929|NCT02117648|Primary|PK: Maximum Concentration (Cmax) of Abemaciclib||Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96,120,144,168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose|All participants who received at least 1 dose of study drug and had evaluable cmax data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1328930|NCT02117648|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib||Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose|All participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) data.|||nanogram*hour/milliliter(mL) ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1328931|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 65 to 85 who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328932|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328933|NCT02117570|Primary|Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328934|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328935|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328936|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328937|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine.|||Percentage of participants||95% Confidence Interval|Number
1328938|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine|||Participants||95% Confidence Interval|Number
1328939|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328959|NCT02117414|Secondary|System-related Complications|Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.|Implant to 4 months post-implant|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.|||Successful participants|||Number
1329483|NCT02108171|Secondary|Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine|Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.|1 day||||bpm||Standard Deviation|Mean
1328940|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328941|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328942|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.|||Percentage of participants||95% Confidence Interval|Number
1328943|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328944|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days after Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
1328945|NCT02117544|Secondary|Low Contrast Visual Acuity (LCVA) Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
1328946|NCT02117544|Secondary|HCVA Intermediate Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
1328947|NCT02117544|Secondary|HCVA Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
1329076|NCT02115646|Primary|Scar Elasticity, Baseline vs 15-months|This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Deviation|Mean
1328948|NCT02117544|Primary|High Contrast Visual Acuity (HCVA) Near Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
1328949|NCT02117479|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).|||Participants|||Count of Participants
1328950|NCT02117479|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
1328951|NCT02117479|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
1328952|NCT02117479|Secondary|Percentage of Participants Achieving Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants||95% Confidence Interval|Median
1328953|NCT02117479|Secondary|Progression-free Survival (PFS)|Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
1328954|NCT02117479|Primary|Overall Survival (OS)|Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.|Randomization until death due to any cause; up to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||Participants|||Count of Participants
1328955|NCT02117414|Secondary|Atrial Sensing Amplitude|Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.|MRI/waiting visit to 1-month post-MRI/Waiting visit|Only subjects with measured atrial sensing amplitude values at both the pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.|||Successful participants|||Number
1328956|NCT02117414|Secondary|Atrial Pacing Capture Threshold (APCT)|Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid APCT measurements pre-MRI/waiting period and post-MRI/waiting period.|||Successful participants|||Number
1328957|NCT02117414|Secondary|Superior Vena Cava (SVC) Defibrillation Impedance|Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured SVC defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.|||Successful participants|||Number
1328958|NCT02117414|Secondary|RV Defibrillation Impedance|Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured RV defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an RV defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.|||Successful participants|||Number
1328960|NCT02117414|Primary|Ventricular Sensing Amplitude (R-wave)|Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.|||Successful participants|||Number
1328961|NCT02117414|Primary|Ventricular Pacing Capture Threshold (VPCT)|Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid VPCT measurements pre-MRI/waiting period and post-MRI/waiting period.|||Successful participants|||Number
1328962|NCT02117414|Primary|MRI-related Events|Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.|MRI procedure to 1-month post-MRI|A total of 156 subjects underwent an MRI scan at the MRI/waiting period visit; of them 147 were followed through the one month post-MRI visit or later and are included in the analysis.|||Participants free of MRI-related events|||Number
1328963|NCT02117310|Primary|Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.|The researcher will administer ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case. This study will determine feasibility of other larger clinical trials using this method.|During surgery||||Participants|||Count of Participants
1328964|NCT02117193|Secondary|Breath Alcohol||6 months|||||||
1328965|NCT02117193|Secondary|Profile of Mood States||6 months|||||||
1328966|NCT02117193|Secondary|Hydration Status|Urine Specific Gravity|After each sequence, up to 8 hours||||g/ml||Standard Deviation|Mean
1328967|NCT02117193|Primary|Biochemical Responses|Glucose after each situation in the morning|After each sequence, up to 8 hours||||mg/dl||Standard Deviation|Mean
1328968|NCT02117193|Primary|Neuromuscular Performance|knee extensor isometric torque|After each sequence, up to 8 hours||||Nm||Standard Deviation|Mean
1328969|NCT02117193|Primary|Aerobic Performance|Aerobic performance will be determined through the subject's heart rate|After each sequence, up to 8 hours||||bpm||Standard Deviation|Mean
1328970|NCT02117050|Secondary|Annualized Relapse Rate (ARR)|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Episodes indicated by neurologist as “relapse” in the subjects chart were to be recorded.|Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1328971|NCT02117050|Secondary|Change From Baseline in Number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24||Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1328972|NCT02117050|Secondary|Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24|WPAI-GH questionnaire is a subject reported quantitative assessment of general health conditions on productivity. The Total WPAI-GH score assessment was to be done on an 11-point scale ranging 0 to 10, with 0 indicating that health problems had no effect on work and 10 indicating that health problems completely prevented from working.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1328973|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects, convenience and global satisfaction sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects, convenience and global satisfaction, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1328974|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects and convenience sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects and convenience, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1328975|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24|The TSQM (Version II) is an 11-item validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Total TSQM score was the average of individual sub-scale scores (effectiveness, side effects, convenience and global satisfaction) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12 and Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1329064|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.|||percentage of participants||95% Confidence Interval|Number
1328976|NCT02117050|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24|The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. MSQoL-54 is a 54 item questionnaire which covers 12 sub-scales along with two summary scores, and two additional single-item measures. The 12 sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The 2 summary scores are the physical health composite summary and the mental health composite summary. The 2 additional single item measures are satisfaction with sexual function and change in health. Each of the 12 sub-scale scores, the 2 summary scores and 2 single item measures were to be converted into an overall Total Score ranging from 0-100, where higher scores indicated better health status.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1328977|NCT02117050|Secondary|Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24|PDDS questionnaire was to be used to assess the walking ability of subjects. Subjects were to describe their walking ability on scale ranging from 0 to 8, where 0 indicated normal walking and 8 indicated subject’s condition as bedridden. Lesser score indicated better walking ability.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
1328978|NCT02117050|Primary|Change From Baseline in Treatment Satisfaction Score Determined by the Global Satisfaction Sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Global satisfaction sub-scale of TSQM was to be used to measure overall satisfaction with medication using a 100-point scale. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for primary endpoint was not collected.||||||
1328979|NCT02116972|Other Pre-specified|Time to Onset of Pain Relief|Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing >30% improvement from the weekly average daily pain score at baseline.|Baseline up to 24 Weeks after administration of study treatment|Time to onset of pain relief for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||days||95% Confidence Interval|Median
1328980|NCT02116972|Other Pre-specified|Proportion of Patients Experiencing a >20%, 30% and 50% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Week 12|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|12 weeks|||||||
1328981|NCT02116972|Other Pre-specified|Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure)|Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in PGIC for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||units on a scale||Standard Error|Least Squares Mean
1328982|NCT02116972|Other Pre-specified|Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Change from baseline to each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A pain for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||units on a scale||Standard Error|Least Squares Mean
1328983|NCT02116972|Other Pre-specified|Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure)|Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported|||units on a scale||Standard Error|Least Squares Mean
1328984|NCT02116972|Other Pre-specified|Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine.Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group"|Baseline and Up to Week 24|Randomized patients who received study drug.|||units on a scale||Standard Error|Least Squares Mean
1328985|NCT02116972|Other Pre-specified|Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
1329075|NCT02115646|Primary|Scar Thickness|This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||mm||Standard Deviation|Mean
1328986|NCT02116972|Other Pre-specified|Change From Baseline to Week 12 for WOMAC C (Function Subscale)|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5- point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
1328987|NCT02116972|Other Pre-specified|Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria|Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.|Weeks 4, 8 and 12|Percent of responders according to Outcomes Measures in OMERACT-OARSI strict criteria for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||Participants|||Count of Participants
1328988|NCT02116972|Secondary|Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline and Weeks 16, 20 and 24|Randomized patients who received study drug.|||units on a scale||Standard Error|Least Squares Mean
1328989|NCT02116972|Secondary|Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
1328990|NCT02116972|Secondary|Change From Baseline to Week 12 for WOMAC C (Function Subscale)|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
1328991|NCT02116972|Primary|Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no painand 10 indicates pain as bad as you can imagine."|Baseline and Week 12|Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm|||units on a scale||Standard Error|Least Squares Mean
1328992|NCT02116803|Primary|Number of Participants With Adverse Events of Grades 3 and 4 Severity|Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row.|Until the last patient discontinued dovitinib up to 30 months|Safety set: the Safety set included all patients who received at least one dose of study medication. Safety set was identical to Full Analysis Set for this study.|||Participants|||Count of Participants
1328993|NCT02116621|Other Pre-specified|Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks|Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1328994|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1328995|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1328996|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1330833|NCT02091752|Secondary|Change From Baseline in Spleen Length and Spleen Volume||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1328997|NCT02116621|Other Pre-specified|Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1328998|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1328999|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329000|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329001|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329002|NCT02116621|Other Pre-specified|Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329003|NCT02116621|Other Pre-specified|Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks|Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329004|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329005|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1330834|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1329006|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329007|NCT02116621|Other Pre-specified|Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329008|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329009|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329010|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329011|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329012|NCT02116621|Other Pre-specified|Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329013|NCT02116621|Other Pre-specified|Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks|Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329014|NCT02116621|Other Pre-specified|Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks|Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.|26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329223|NCT02111369|Primary|Change in Acoustic Spectrograms|"Objective Voice Assessment~• Using the Computerized Speech Laboratory speech and voice analysis system (KayPENTAX, Montvale, NJ)"|baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.||||||
1329015|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329016|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329017|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329018|NCT02116621|Other Pre-specified|Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329019|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329020|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329021|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329022|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329023|NCT02116621|Other Pre-specified|Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329224|NCT02111369|Primary|Change in Global Voice Rating|"Patient-Reported Measure~• 0-7 ranking"|Baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.||||||
1329024|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329025|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329026|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329027|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329028|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329029|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329030|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329031|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329032|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329033|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale|Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
1329034|NCT02116621|Primary|Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks|Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1329035|NCT02116582|Secondary|Number of Participants With Adverse Events (AEs)|A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).|From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.|||Participants|||Number
1329036|NCT02116582|Secondary|Time to PSA Progression|The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progression median. A 2-sided 95% CI was provided for this estimate using the BC method.|From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.|||Months||95% Confidence Interval|Median
1329037|NCT02116582|Secondary|Percentage of Participants With a Prostate-specific Antigen (PSA) Response|PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution.|From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.|||Percentage of participants||95% Confidence Interval|Number
1329049|NCT02116361|Primary|Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Week 6|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Error|Least Squares Mean
1329038|NCT02116582|Secondary|Overall Survival (OS)|OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discontinued study drug. OS median was estimated using the KM method. A 2-sided 95% CI was provided for this estimate using the BC method.|From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years.|The analysis population consisted of the SAF.|||Months||95% Confidence Interval|Median
1329039|NCT02116582|Primary|Radiographic Progression-free Survival (rPFS)|Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer & Crowley (BC) method.|From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.|The analysis population consisted of the safety analysis set (SAF) which consisted of all participants who took at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
1329040|NCT02116530|Secondary|Frequency of Rescue Medication|Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.|Day 2 to Day 6 after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had rescue medication data at each time point.|||Participants|||Count of Participants
1329041|NCT02116530|Secondary|Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire|Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).|Baseline and day 2 to 6 days after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had toxicities data at each time point.|||units on a scale||Standard Deviation|Mean
1329042|NCT02116530|Secondary|Proportion of Patients With Complete Response|Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.|0 to 120 hours after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had data on emetic and use of rescue medication questions.|||percentage of participants|||Number
1329043|NCT02116530|Secondary|Median Nausea Scores|Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).|Baseline and Day 2 to Day 6 after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data at each time point.|||units on a scale||Full Range|Median
1329044|NCT02116530|Primary|Proportion of Patients With no Nausea|No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.|0 to 120 hours after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data.|||percentage of participants|||Number
1329045|NCT02116361|Secondary|Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)|The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|24 Weeks|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Error|Least Squares Mean
1329046|NCT02116361|Secondary|Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)|The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Baseline|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
1329047|NCT02116361|Secondary|Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score|The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|24 Weeks|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Error|Least Squares Mean
1329048|NCT02116361|Secondary|Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score|The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Baseline|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
1329114|NCT02114892|Secondary|Creatinine at Week 12.|The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12|Baseline. Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||µmol/l||Standard Deviation|Mean
1329050|NCT02116361|Primary|Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Baseline|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
1329051|NCT02116322|Secondary|Diagnostic Yield of the FNA Using Corkscrew Technique|Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis.|30 days||||percentage of masses|||Number
1329052|NCT02116322|Primary|Number of Participants With Adverse Events as a Measure of Safety||30 days||||participants|||Number
1329053|NCT02116309|Secondary|Number of Patients Who Developed Severe Post-ERCP Pancreatitis|Severity of PEP defined using the consensus grading as Mild PEP that results in hospitalization (or prolongation of existing hospitalization) for ≤3 days. Moderate PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for 4-10 days. Severe PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for > 10 days, or leads to the development of pancreatic necrosis or pseudocyst, or requires additional endoscopic, percutaneous, or surgical intervention.|up to 30 days after ERCP||||Participants|||Count of Participants
1329054|NCT02116309|Primary|Number of Patients Who Developed Post-ERCP Pancreatitis|The primary outcome variable of interest is the incidence of post ERCP pancreatitis (PEP) as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis and 2) amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure and 3) Hospitalization or prolongation of existing hospitalization for at least 2 days.|24 hours after ERCP||||Participants|||Count of Participants
1329055|NCT02115984|Primary|The Quantity of Leukocytes and Neutrophils in the Blood of Patients||Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)||||10^9 cells/L||Inter-Quartile Range|Median
1329056|NCT02115828|Secondary|The Effect of Vismodegib on PSA Responses|The effect of vismodegib on PSA responses will be assessed as the number of patients with participants with ≥50% PSA reductions at any time point during study|Up to 1 Year|Seven patients were evaluable for PSA response. One participant had no measurable PSA production at enrollment, and PSA remained <0.01 throughout the study. A second patient had disease progression prior to the first on-study PSA evaluation.|||participants|||Number
1329057|NCT02115828|Secondary|AKT1 Expression in Tumor Biopsies|The tumor biopsies were evaluated for changes to Hh-regulated transcript, AKT1, between pre-treatment and post-treatment|Up to 1 Year|One patient did not receive a post-treatment biopsy, and another patient had insufficient tissue for evaluation from the repeat biopsy|||expression fold change||Full Range|Median
1329058|NCT02115828|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined by the Prostate Cancer Working Group 2 (PCWG2) criteria using RECIST 1.1 criteria for each patient. PFS is defined as the time of first dose (a) until prostate specific antigen (PSA) progression (by 25% increase in PSA from nadir) or death and (b) until any evidence of progression (by 25% increase in PSA from nadir, a new lesion on bone or CT scan, or physical examination) or death. PFS will be assigned to the earliest observed time.|Up to 1 Year||||months||95% Confidence Interval|Median
1329059|NCT02115828|Secondary|GLI1 Expression|Suppression by vismodegib in tumor tissue of Hh-regulated transcripts and proteins was defined as the change from baseline in expression levels of GLI1 in situ tissue expression by mRNA in situ hybridization.|Up to 1 Year|One patient did not receive a post-treatment biopsy, and another patient had insufficient tissue for evaluation from the repeat biopsy|||expression fold change||Full Range|Median
1329060|NCT02115828|Primary|The Proportion of mCRPC Patients Treated With Vismodegib Who Achieve a Pharmacodynamic (PD) Response in Tumor Biopsies|The primary endpoint is the proportion of mCRPC patients treated with vismodegib who achieve a pharmacodynamic (PD) response in tumor biopsies, defined as both a decrease in GLI1 mRNA greater than 1.2 times the standard deviation (SD) of the baseline values and a ≥50% (≥2-fold) reduction in GLI1 messenger ribonucleic acid (mRNA) expression in metastatic tumor biopsies after 4 weeks of treatment when comparing post-treatment biopsy to pre-treatment biopsy in the same patient.|Up to 1 year|The design had 90% power to detect a true 65% PD response rate across patients, with a false-positive rate of 3.3% under the null hypothesis that vismodegib has no effect in downregulating Gli1 expression.|||Participants|||Count of Participants
1329061|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline|Day 8|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.|||percentage of participants||95% Confidence Interval|Number
1329062|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
1329063|NCT02115815|Secondary|Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Baseline (Day 1), Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."|||spot forming counts per 10^6 PBMCs||95% Confidence Interval|Geometric Mean
1329065|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||fold rise||95% Confidence Interval|Geometric Mean
1329066|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||titer||95% Confidence Interval|Geometric Mean
1329067|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.|||percentage of participants||95% Confidence Interval|Number
1329068|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||fold rise||95% Confidence Interval|Geometric Mean
1329069|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||titer||95% Confidence Interval|Geometric Mean
1329070|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving investigational product and was assessed by investigator as medically significant.|From Day 1 to Day 361|As-treated Population (ATP) included participants who received any study investigational product.|||participants|||Number
1329071|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state.|From Day 1 to Day 28|As-treated Population (ATP) included participants who received any study investigational product.|||participants|||Number
1329072|NCT02115815|Primary|Number of Participants With Solicited Symptoms|Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (>=) 100.4 degrees F by any route from Day 1 to Day 7.|Day 1 to Day 7|As-treated Population (ATP) included participants who received any study investigational product.|||participants|||Number
1329073|NCT02115646|Secondary|POSAS|The Patient and Observer Scar Assessment Scale (POSAS) is a validated scale that measures both the patient assessment and the observer assessment on the quality (height, color, stiffness, thickness, symptoms, relief, surface area) of the scar. Scores range from 0-60, with 60 being the worst quality of scar.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Error|Mean
1329074|NCT02115646|Secondary|Quality of Life|The 36-Item Short Form Survey (SF-36) is a validated quality of life measurement tool. It measures 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. It is scored on a 0-100 scale, with 100 being the least bothersome to quality of life.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Deviation|Mean
1329077|NCT02115646|Primary|Scar Pigmentation, Baseline vs 15-months|Using the colorimeter, will measure change in pigmentation of the scar at the conclusion of the study. This tool measures the pigment in a scar, with a possible range of 0-100, with 100 being the darkest hyperpigmentation, and 0 being no hyperpigmentation.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Deviation|Mean
1329078|NCT02115581|Primary|Improvement in Left Ventricular Filling Abnormality|Doppler-derived transmitral blood flow and pulmonary venous blood flow data were used for grading of the severity of diastolic filling abnormality in patients before and after the intervention. Diastolic filling abnormality was categorized as: 1- normal 2- abnormal relaxation 3- pseudonormal 4- restricted pattern based on echo data. The proportion of patients who showed improvement in the diastolic function grading was compared between the study groups.|6 months||||Percentage|||Number
1329079|NCT02115581|Primary|Improvement in Left Ventricular Ejection Fraction|Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography|6 months||||Percentage||Standard Deviation|Mean
1329080|NCT02115581|Secondary|Adverse Events|Number of patients with evidence of adverse reaction to coenzyme Q10 including nausea, vomiting, changes in blood pressure, neurological signs or any abnormal behavior like disquiet in young children.|6 months||||Participants|||Number
1329081|NCT02115347|Secondary|Number of Participants Who Experienced an Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 19 days|The analysis population was defined as all treated participants. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||Participants|||Number
1329082|NCT02115347|Secondary|Cmax for Fraction of Ertugliflozin Unbound in Plasma (Cmax,u)|Maximum plasma concentration for unbound drug (ertugliflozin only).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the Cmax,u parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1329083|NCT02115347|Secondary|Maximum Plasma Concentration (Cmax) of Ertugliflozin|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the Cmax parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1329084|NCT02115347|Secondary|AUCinf for Fraction of Ertugliflozin Unbound in Plasma (AUCinf,u)|Area under the plasma concentration-time profile from time zero extrapolated to infinite time for unbound drug (ertugliflozin only) (AUCinf, u).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUCinf,u parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1329085|NCT02115347|Secondary|AUClast for Fraction of Ertugliflozin Unbound in Plasma (AUClast,u)|Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) for unbound drug (ertugliflozin only).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUClast,u parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1329086|NCT02115347|Primary|AUC From Hour 0 to Infinity (AUCinf) for Ertugliflozin|Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUCinf parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1329087|NCT02115347|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin|Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (AUClast).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUClast parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1329088|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA levels <LLoQ 24 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 36|The FAS consists of all randomized participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1329115|NCT02114892|Secondary|Low Density Lipoproteins (c-LDL) at Week 12|The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
1329089|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA levels <LLoQ 4 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 16|The FAS consists of all randomized participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1329090|NCT02115321|Secondary|Percentage of Participants With HCV RNA <LLoQ at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Weeks 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.||||||
1329091|NCT02115321|Secondary|Percentage of Participants With HCV RNA Undetectable at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.||||||
1329092|NCT02115321|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores in CP-B Participants|The MELD score provides an objective and granular assessment of liver improvement as a continuous variable. The calculation of MELD score is based on three biochemical variables (serum bilirubin, creatinine and international normalized ratio [INR] of prothrombin time). The MELD equation is as follows: 9.57 x ln(creatinine mg/dL) +3.78 x ln(bilirubin mg/dL) +11.2 x ln (INR) + 6.43. Scores are multiplied by 10 and rounded to the nearest whole number and range from 6 (less ill) to 40 (gravely ill). MELD scores were determined at Baseline (Day 1) and again at Week 12, Follow-up (FU) Week 12 (Week 24), and FU Week 24 (Week 36). Change from baseline in MELD score = Post-baseline MELD score - baseline MELD score.|Baseline and Weeks 12, 24, and 36|All CP-B participants in the FAS (all randomized participants who received at least one dose of study medication) with available data.|||Units on a scale||Standard Deviation|Mean
1329093|NCT02115321|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|The APaT population consisted of all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
1329094|NCT02115321|Primary|Number of Participants Experiencing an Adverse Event (AE) During Treatment and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 weeks|The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
1329095|NCT02115321|Primary|Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 24|The Full Analysis Set (FAS) consists of all randomized participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1329096|NCT02115269|Secondary|Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack|Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)|baseline|Patients who took trip tans in the past (data are from Safety set which included all enrolled patients who have taken at least one dose of IndoProCaf).|||percentage of participants|||Number
1329097|NCT02115269|Secondary|Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 48 hours|Patients who had headache relapse. Headache relapse was defined as a worsening of headache attack after 24 hours of the initial dosing and pain-free at 2h but no later than 48 hours of initial IndoProCaf dosing.|||percentage of participants|||Number
1329098|NCT02115269|Secondary|Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 2 hours|Patients who took second IndoProCaf dose at 2 hours post-dose|||percentage of participants|||Number
1329099|NCT02115269|Secondary|Time to Significant Pain Reduction|Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 24 hours post-dose|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.|||participants|||Number
1329100|NCT02115269|Primary|Percentage of Patients Who Are Satisfied With IndoProCaf Treatment|Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers.|up to 24 hours post dose|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.|||percentage of participants|||Number
1330835|NCT02091752|Secondary|Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1329101|NCT02115269|Primary|Percentage of Patients With Significant Pain Reduction|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 2 hours|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.|||percentage of participants|||Number
1329102|NCT02115256|Secondary|Tachycardia|Number of participants that had tachycardia|average of 1 hour||||Participants|||Count of Participants
1329103|NCT02115256|Secondary|Need for Cesarean Delivery|Number of participants that needed a cesarean delivery|average of 1 hour||||Participants|||Count of Participants
1329104|NCT02115256|Secondary|Hypotension|Number of participants with hypotension|average of 1 hour||||Participants|||Count of Participants
1329105|NCT02115256|Primary|Successful Version of the Fetus Into the Vertex Position|Number of participants that had successful version of the fetus into the vertex position.|average of 1 hour||||Participants|||Count of Participants
1329106|NCT02114931|Secondary|Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).~The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity."|Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70|Full analysis set with available data at each time point|||units on a scale||Standard Deviation|Mean
1329107|NCT02114931|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response|"A participant was a responder if the following 3 criteria for improvement from Baseline of the parent study were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70|The full analysis set (all participants enrolled in the extension study) with available data at each time point|||percentage of participants|||Number
1329108|NCT02114931|Primary|Percentage of Participants Who Developed Antibodies to ABP 501|"Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study."|Up to week 72|The anti-drug antibody analysis set includes participants who received at least 1 dose of ABP 501 in the extension study and who had at least 1 evaluable antibody test assay against ABP 501 in the extension study.|||percentage of participants|||Number
1329109|NCT02114931|Primary|Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results|"Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:~1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal."|From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks|Safety analysis set|||participants|||Number
1329110|NCT02114931|Primary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:~1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question “is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product” was yes.~A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening (places the subject at immediate risk of death)~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks|The safety analysis set included all participants enrolled and treated with at least 1 dose of ABP 501 in the extension study.|||participants|||Number
1329111|NCT02114892|Primary|Diastolic Blood Pressure at Week 12|The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mmHg||Standard Deviation|Mean
1329112|NCT02114892|Primary|Waist Circumference at Week 12|Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||cm||Standard Deviation|Mean
1329113|NCT02114892|Secondary|Uric Acid at Week 12.|The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12|Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||µmol/l||Standard Deviation|Mean
1330836|NCT02091752|Primary|Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1329116|NCT02114892|Secondary|Total Cholesterol at Week 12|The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
1329117|NCT02114892|Secondary|Body Mass Index at Week 12|The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||kg/m2||Standard Deviation|Mean
1329118|NCT02114892|Secondary|Weight at Week 12.|The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||kg||Standard Deviation|Mean
1329119|NCT02114892|Primary|Total Insulin Sensitivity at Week 12.|The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||unitless||Standard Deviation|Mean
1329120|NCT02114892|Primary|Total Insulin Secretion at Week 12.|The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||unitless||Standard Deviation|Mean
1329121|NCT02114892|Primary|First Phase of Insulin Secretion at Week 12.|The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||unitless||Standard Deviation|Mean
1329122|NCT02114892|Primary|Systolic Blood Pressure at Week 12.|The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mmHg||Standard Deviation|Mean
1329123|NCT02114892|Primary|Fasting Glucose Levels at Week 12.|The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mmol/L||Standard Deviation|Mean
1329124|NCT02114892|Primary|High Density Lipoprotein (c-HDL) Levels at Week 12.|The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
1329125|NCT02114892|Primary|Triglycerides Levels at Week 12|The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
1329126|NCT02114697|Primary|Plaque Volume of Carotid Arteries|Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events.|Baseline, 18 months, 36 months|This analysis includes all participants who completed the MRI at each time point. Most participants did not return for the follow up MRI measurements.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
1329127|NCT02114268|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.|Predose and Day 15, 31, 91, 181, 271 and 361|The As-treated Population included participants who receive any study investigational product.|||participants|||Number
1329128|NCT02114268|Secondary|Volume of Distribution (Vz) for MEDI8897|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||milliliter (ml)||Standard Deviation|Mean
1329129|NCT02114268|Secondary|Systemic Clearance (CL) for MEDI8897|Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||ml per day||Standard Deviation|Mean
1329157|NCT02114151|Secondary|Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants.|Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Participants|||Number
1329130|NCT02114268|Secondary|Terminal Phase Elimination Half Life (t1/2) for MEDI8897|The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here ‘n’ signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||Day||Standard Deviation|Mean
1329131|NCT02114268|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897|The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||Day*microgram per milliliter||Standard Deviation|Mean
1329132|NCT02114268|Secondary|Maximum Observed Serum Concentration (Cmax) for MEDI8897|The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
1329133|NCT02114268|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897|The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||Day||Standard Deviation|Mean
1329134|NCT02114268|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.|From start of study drug administration up to Day 391 (Day 361 +/- 30 days)|The As-treated population included participants who receive any study investigational product.|||participants|||Number
1329135|NCT02114216|Secondary|PAR2 and IL-8 Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers’ instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks||||Fold change||Standard Error|Mean
1329136|NCT02114216|Primary|TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers’ instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks||||Fold change||Standard Error|Mean
1329137|NCT02114203|Secondary|Time for Maximum Observed Plasma Concentration (Tmax) of PF-04447943||Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1|The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.|||hours||Full Range|Median
1329138|NCT02114203|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04447943||Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1|The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1329139|NCT02114203|Secondary|Area Under the Curve From Time Zero to 12 Hours Post Dose (AUC(0-12h)) of PF-04447943|AUC(0-12h) referred to area under the plasma concentration-time curve from 0 to 12 hours post dose.|Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1|The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.|||nanogram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
1329500|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1329140|NCT02114203|Primary|Number of Participants With Laboratory Test Abnormalities|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, serum creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and high sensitivity C-reactive protein), urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone and serum human chorionic gonadotropin, urine drug screening). Abnormality was determined by the investigator.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
1329141|NCT02114203|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to follow-up visit (30 days post last dose on Day 29) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.|Day 1 to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
1329142|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease|The following symptoms were assessed: anemia; fatigue; chronic pain; acute pain; infections; fever; swelling hands; swelling feet; abdominal swelling; pale skin; pale nail beds; yellow tint to skin; whites of eyes turned yellow; stroke. Number of participants with changes from baseline deemed potentially clinically important by the investigator is presented.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
1329143|NCT02114203|Primary|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=200 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval percent increase from baseline >=25/50 percent; (7) QRS complex percent increase from baseline >=25/50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
1329144|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings|Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical importance of physical examination changes was determined by the investigator.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
1329145|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function|Clinical assessment of neurologic functions included cranial nerve function, coordination, deep tendon reflexes, muscle strength, and reflexes (left and right ankles). Clinical importance of neurologic function changes was determined by the investigator.|Baseline up to Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
1329146|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs|Number of participants with changes from baseline in vital signs meeting the following criteria is presented: (1) maximum increase from baseline in supine systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg); (2) maximum increase from baseline in supine diastolic blood pressure (DBP) >=20 mmHg; (3) maximum decrease from baseline in supine SBP >=30 mmHg; and (4) maximum decrease from baseline in supine DBP >=20 mmHg.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
1329147|NCT02114177|Secondary|Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale|"The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening."|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
1329168|NCT02114151|Primary|Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment.|Week 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants||95% Confidence Interval|Number
1329148|NCT02114177|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores|The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
1329149|NCT02114177|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
1329150|NCT02114177|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)|HCVSIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
1329151|NCT02114177|Secondary|Percentage of Participants With Viral Relapse|Percentage of participants who did not achieve sustained virologic response 12, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1329152|NCT02114177|Secondary|Percentage of Participants With Viral Breakthrough|Percentage of participants with greater than 1 log10 IU/mL increase in plasma Hepatitis C virus ribonucleic acid level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been less than 25 IU/mL.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
1329153|NCT02114177|Secondary|Percentage of Participants Achieving a On-treatment Virologic Response|Ontreatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Day 14, Day 28, End of treatment (Week 8 or Week 12)|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of participants|||Number
1329154|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|Participants considered to have achieved SVR24, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 24 weeks after the Actual end of study drug treatment.|24 weeks after the end of treatment (EOT) (Week 32 or Week 36)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1329155|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)|Participants considered to have achieved SVR4, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 4 weeks after the actual end of study drug treatment.|4 weeks after the end of treatment (EOT) (Week 12 or Week 16)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1329156|NCT02114177|Primary|Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.|12 weeks after the end of treatment (EOT) (Week 20 or Week 24)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1329209|NCT02112370|Secondary|Maximum of Measured Diastolic Blood Pressures|The maximal diastolic blood pressure is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||mmHg||Standard Deviation|Mean
1329210|NCT02112370|Secondary|Maximum of Measured Systolic Blood Pressures|The maximal systolic blood pressure is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||mmHg||Standard Deviation|Mean
1329158|NCT02114151|Secondary|Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24|"The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health)."|Baseline, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a Scale||Standard Error|Mean
1329159|NCT02114151|Secondary|Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of Participants|||Number
1329160|NCT02114151|Secondary|Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a Scale||Standard Error|Mean
1329161|NCT02114151|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12|The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline, Week 4, Week 12 and Follow-Up Week 12|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a Scale||Standard Error|Mean
1329162|NCT02114151|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period.|During the Follow-up (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1329163|NCT02114151|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL).|Up to End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants|||Number
1329164|NCT02114151|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|Intent-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Percentage of Participants|||Number
1329165|NCT02114151|Secondary|Percentage of Participants With On-treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Week 2, 4 and End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of Participants|||Number
1329166|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment.|Week 36|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants||95% Confidence Interval|Number
1329167|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment.|Week 16|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants||95% Confidence Interval|Number
1329169|NCT02113579|Secondary|Global Subjective VAS Score at Week 4|At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:“Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.” The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
1329170|NCT02113579|Secondary|Global Subjective VAS Score at Week 2|At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:“Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product.” The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
1329171|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
1329172|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
1329173|NCT02113579|Secondary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||percentage of participants|||Number
1329174|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||grams||Standard Error|Least Squares Mean
1329175|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
1329176|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||grams||Standard Error|Least Squares Mean
1329177|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
1329625|NCT02106962|Primary|Clotting TIme|After completing dialysis, the clotting time of the arteriovenous fistula of each participant was measured, using either Tranexamic Acid 5% or Tranexamic Acid 25% and compared to the regular clotting time of the AV Fistula without using the Tranexamic Acid|13 minutes||||minutes||Full Range|Mean
1329178|NCT02113579|Primary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|4 Weeks|Analysis was based on Full Analysis Set, which included all randomized subjects.|||percentage of participants|||Number
1329179|NCT02113449|Primary|Provide a Score From 1-7 to Some Statements, Depending on How Much You Think Each Statement Applies or Does Not Apply to the Spray Product That You Used|A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it. You can use any score from 1 to 7 to indicate how much or how little you think the statement applies to this product|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329180|NCT02113449|Primary|How Often do You Think This Spray Product Would Last for You Personally?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329181|NCT02113449|Primary|Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329182|NCT02113449|Primary|How Many Packages Would You Buy?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience.This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329183|NCT02113449|Primary|If the Product You Just Tried (After At-home Use) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329184|NCT02113449|Primary|Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option. It was done to compare the spray with the product selected by the participant in Q1. There were 11 points between the two products that participants could divide anyways thet wanted (11-0, 10-1, 9-2, 8-3, 7-4 or 6-5 etc). The more the participant liked a product compared to other, the higher the number of points were to be given to that product.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329185|NCT02113449|Primary|Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329186|NCT02113449|Primary|Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329187|NCT02113449|Primary|If the Product You Just Tried (After First Dose) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329188|NCT02113449|Primary|Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first use. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329189|NCT02113449|Primary|Which One Product That Relieves Nasal Congestion do You Buy Most Often?|"There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked as part of screening survey prior to concept viewing. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that didnot perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
1329190|NCT02113436|Secondary|Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 2 (TP2)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant in a patient diary twice daily (daytime and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP2 (Week 24). Scores ranged from 0 (none) to 3 (severe) and maximum score is 6 per day. Change from Baseline in the asthma symptom scores at daytime plus night time at the end of TP2 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]).The end of the TP2 value is a mean value of the last 7 consecutive days during the TP2 (excluding the last day of the TP2). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who received at least one dose of open-label medication in the TP2 were analyzed.|Baseline and Week 24|ITT Population|||Scores on a scale||Standard Deviation|Mean
1329191|NCT02113436|Secondary|Mean Change From Baseline in Use of Rescue Medication (Percentage of Days With Rescue-free 24-hour Period) at the End of Treatment Period 1 (TP1)|The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population|||Percentage of days||Standard Error|Least Squares Mean
1329192|NCT02113436|Secondary|Mean Change From Baseline in Use of Rescue Medication (Number of Occasions Used During a 24-hour Period) in Treatment Period 1 (TP1)|The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary from Baseline (Week -1) until Week 8. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8 weeks in TP1 were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population|||Occasions per 24 hours||Standard Error|Least Squares Mean
1329193|NCT02113436|Secondary|Mean Change From Baseline in Japanese Pediatric Asthma Control Program (JPAC) Score at the End of Treatment Period 1 (TP1)|Severity and control statuses based on Japanese pediatric guideline for the treatment and management of asthma (JPGL) can be assessed according to JPAC. Theoretically range of JPAC score was 0 (poor control) to 18 (complete control) point. JPAC questionnaire was recorded at Baseline (Week -2) and Week 8 by the participant's parent or legally acceptable representative who knew the participant's asthma for the last month. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.|Baseline and Week 8|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1329194|NCT02113436|Secondary|Number of Participants With at Least One Asthma Exacerbation in Treatment Period 1 (TP1)|The definition of exacerbations was amended during the study. <Original> An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral, or depot) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. <Amendment> An asthma exacerbation is defined as deterioration of asthma requiring the use of prednisone or hydrocortisone equivalent systemic corticosteroids for at least 3 days, or requiring the use of dexamethasone or betametasone equivalent systemic corticosteroids (oral, intravenous or intramuscular), or requiring the use of systemic depot corticosteroids once, or an in-patient hospitalization that required treatment for respiratory symptom with wheezing, or emergency department visit due to asthma that required intravenous systemic corticosteroids.|Up to 8 weeks|ITT Population|||Participants|||Number
1329211|NCT02112370|Primary|NRS Pain Scores for the First 12 Hours|"The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)~Unlike the general NRS pain score as reported in the post-operative 48 hour result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place."|Postoperative 12 hours||||points||Standard Deviation|Mean
1329212|NCT02111863|Secondary|Overall Survival (OS) of Patients Receiving a Lymphocyte Depleting Preparative Regimen|OS is defined as the time between the first day of treatment to the day of death or date last known alive.|up to 3 years||||months||Full Range|Median
1329195|NCT02113436|Secondary|Mean Change From Baseline in Daytime Asthma Symptoms Score at the End of Treatment Period 1 (TP1)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the day in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at day time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
1329196|NCT02113436|Secondary|Mean Change From Baseline in Night-time Asthma Symptoms Score at the End of Treatment Period 1 (TP1)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the night in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at night time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1329197|NCT02113436|Primary|Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 1 (TP1)|The participant’s parent or legally acceptable representative made entries asthma symptom experienced by the participant in a patient diary twice daily (day time and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 6 per day. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population: all randomized par. who received at least one dose of study medication.|||Scores on a scale||Standard Error|Least Squares Mean
1329198|NCT02113124|Primary|Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating|5 ml of blood will be acquired following a 8-hour fasting period to determine baseline concentrations of amino acids. A meal will then be provided and another blood sample will be acquired 90 minutes after completing the meal to examine the change in amino acid concentration. These samples will be used to determine the levels of each essential amino acid present.|Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal||||µM||Standard Error|Mean
1329199|NCT02113007|Secondary|Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.|Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.|up to 4 weeks||||participants|||Number
1329200|NCT02113007|Secondary|Progression Free Survival (PFS)|Six and twelve-month CNS progression-free survival rate.|6 and 12 months|The study closed early due to slow accrual; outcome measure not reached.||||||
1329201|NCT02113007|Primary|Overall Response Rate|Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.|approximately 32 weeks|The study closed early due to slow accrual. This outcome measure was not reached.||||||
1329202|NCT02112448|Secondary|Length of Stay|Length of stay will be recorded for each subject.|From date of randomization until the date of first documented progression or date of death from any cause or discharge, whichever came first, assessed up to 100 months||||days||Standard Deviation|Mean
1329203|NCT02112448|Primary|Total Morphine Dosage|Total dose of morphine used will be recorded for each patient.|24 hours||||mg/kg||Standard Deviation|Mean
1329204|NCT02112370|Secondary|Pain Killer Dose|Change in pain killer usage with time|0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation||||vials (15mg ketorolac per vial)||Standard Deviation|Mean
1329205|NCT02112370|Secondary|NRS Change|"Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)"|0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation||||scores on a scale||Standard Deviation|Mean
1329206|NCT02112370|Secondary|Operation Time|The amount of time taken from start to the end of surgery|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||minutes||Standard Deviation|Mean
1329207|NCT02112370|Secondary|Blood Loss Amount|The blood loss amount is estimated at the end of surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||ml||Standard Deviation|Mean
1329208|NCT02112370|Secondary|Maximum of Measured Heart Rates|The maximal heart rate is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||beats per minute||Standard Deviation|Mean
1329213|NCT02111863|Primary|Objective Response Rate of Patients With Metastatic Melanoma|Objective response is defined as complete response + partial response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|approximately 2 years||||percentage of participants|||Number
1329214|NCT02111863|Primary|Count of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|2 years and 59 days||||Participants|||Count of Participants
1329215|NCT02111772|Secondary|Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection Evaluated Without Cough.|Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|4 days|One asthmatic subject completed the study, but was dropped according to protocol because that subject acquired a cold after enrollment, but before rhinovirus inoculation. One subject without asthma was dropped according to protocol, because they did not develop a cold after inoculation with rhinovirus.|||units on a scale||95% Confidence Interval|Mean
1329216|NCT02111772|Primary|Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection|The primary endpoint will be based on the comparison of cumulative lower respiratory tract symptom scores (CLRTS) in the asthmatic subjects compared to the non-asthmatic subjects over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, shortness of breath, and cough. Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 24. The scores recorded daily could range from 0 to 24.|4 days|One asthmatic subject completed the study, but was dropped according to protocol because that subject acquired a cold after enrollment, but before rhinovirus inoculation. One subject without asthma was dropped according to protocol, because they did not develop a cold after inoculation with rhinovirus.|||units on a scale||95% Confidence Interval|Mean
1329217|NCT02111603|Secondary|Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA)|"Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Relative composition of the main individual bile acids (cholic acid (CA), chenodeoxycholic acid (CDCA), deoxycholic acid (DCA), lithocholic acid (LCA) and ursodeoxycholic acid (UDCA)) in 48 hour stool collection after colesevelam treatment were compared to baseline values.~The concordance correlation coefficient (rc) measures agreement between two variables. The concordance correlation satisfies -1 ≤ rc ≤ +1. A value of rc = +1 corresponds to perfect agreement. A value of rc = -1 corresponds to perfect negative agreement, and a value of rc = 0 corresponds to no agreement."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||concordance correlation coefficient||Standard Error|Mean
1329218|NCT02111603|Secondary|Change in Stool Frequency (Number of Stools Per Week)|Change in stool frequency from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||Number of stools per week||Standard Error|Mean
1329219|NCT02111603|Secondary|Change in Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Form Scale. The Bristol Stool Form Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||units on a scale||Standard Error|Mean
1329220|NCT02111603|Secondary|Change in Fecal Fat Excretion|Change in fecal fat excretion from baseline in response to treatment with colesevelam|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||g/day||Standard Error|Mean
1329221|NCT02111603|Secondary|Change in Fasting Serum C4|Change in fasting serum C4 from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||ng/mL||Standard Error|Mean
1329222|NCT02111603|Primary|Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam|Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||uM||Standard Error|Mean
1334073|NCT02029521|Primary|Weight Percentile at 3 Months|Weight Percentile at 3 months adjusted for sex and age|3 months|All participants.|||Weight Percentile, sex and age adjusted||Standard Deviation|Mean
1329225|NCT02111369|Primary|Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score|"The CAPE-V is a clinically validated perceptual voice assessment tool that is used to describe the severity of auditory-perceptual attributes of a voice problem, in a way that can be communicated among clinicians. Participant's speech is recorded and evaluated by trained listeners. Listeners indicate overall tremor severity by making a tick mark on a 1 to 100 mm visual analog scale. Total scores range from 0 to 100 where 0 is the best score and 100 is the worst score."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).|||units on a scale||Standard Deviation|Mean
1329226|NCT02111369|Primary|Change in Voice-Related Quality Of Life (VRQOL) Questionnaire Score|"The VRQOL is a ten question self-reported measure that asks patients to rate responses from 1-5 (1=none, not a problem, 2=a small amount, 3=a moderate (medium) amount, 4=a lot, 5=problem is as bad as it can be). Total scores range from 0 to 100. A higher score indicates more problems interfering with day to day activities."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).|||units on a scale||Standard Deviation|Mean
1329227|NCT02111369|Primary|Change in Quality of Life in Essential Tremor (QUEST) Questionnaire Score|The QUEST questionnaire is a 30 item self-reported essential tremor-specific quality of life scale that asks participants to rate responses (never/no, rarely, sometimes, frequently, always/yes, or not applicable). Total scores range between 0 to 100 where 0 is the best score and 100 is the worst score. A higher score indicates a lower quality of life.|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).|||units on a scale||Standard Deviation|Mean
1329228|NCT02111252|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer|Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22||||Fold Change||95% Confidence Interval|Geometric Mean
1329229|NCT02111252|Secondary|Seroconversion Rate of SRH Antibody Titer|Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22||||percentage of participants||95% Confidence Interval|Number
1329230|NCT02111252|Secondary|Seroprotection Rate of SRH Antibody Titer|Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.|||percentage of participants||95% Confidence Interval|Number
1329231|NCT02111252|Secondary|GMT of Single Radial Hemolysis (SRH) Antibody Titer|GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.|||mm^2||95% Confidence Interval|Geometric Mean
1329232|NCT02111252|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer|Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination|Day 22|The full analysis set was used.|||titer||95% Confidence Interval|Geometric Mean
1329233|NCT02111252|Secondary|Change From Baseline in Safety Electrocardiogram (ECG) Parameters|The ECG data will be analyzed into 3 categories, `normal`, `abnormal but not clinically significant` and `abnormal clinically significant`. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).|Day 1 and Day 22||||participants|||Number
1329234|NCT02111252|Secondary|Change From Baseline in Blood Pressure|For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.|Day 1 (Baseline), Day 8, Day 22||||mmHg||Standard Deviation|Mean
1329235|NCT02111252|Primary|Geometric Mean Fold Increase in HI Antibody Titer|Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22|The full analysis set was used.|||Fold Change||95% Confidence Interval|Geometric Mean
1329236|NCT02111252|Primary|Seroconversion Rate of HI AntibodyTiter|Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22||||Percentage of participants||95% Confidence Interval|Number
1329237|NCT02111252|Primary|Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer|Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22|The full analysis set was used.|||Percentage of participants||95% Confidence Interval|Number
1329238|NCT02111252|Primary|Number of Participants With Solicited Injection Site and Systemic Adverse Events|Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.|For 22 days|The safety analysis set, comprised the volunteers who received a single dose of 0.5 mL TAK-850, was used.|||participants|||Number
1329239|NCT02111200|Primary|Total Nitrogen as a Conjugate of the Drug|The objective of this protocol is to directly compare the efficacy of benzoate, phenylbutyrate and a combination of the two, to conjugate nitrogenous compounds in healthy volunteers. The nitrogenous compound of interest in each arm would be based on the medication used. This would be hippuric acid in the benzoate arm, phenylacetylglutamine in the phenylbutyrate arm, and hippuric acid AND phenylacetylglutamine in the MIX arm.|4 days per arm||||mmol/24 hours||Standard Deviation|Mean
1329282|NCT02110693|Primary|Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
1329240|NCT02111200|Primary|Urinary PAGN Excretion|The objective of this protocol is to directly compare the efficacy of benzoate, phenylbutyrate and a combination of the two, to conjugate nitrogenous compounds in healthy volunteers. The nitrogenous compound of interest in each arm would be based on the medication used. This would be hippuric acid in the benzoate arm, phenylacetylglutamine in the phenylbutyrate arm, and hippuric acid AND phenylacetylglutamine in the MIX arm. The mean phenylacetylglutamine levels in the benzoate arm would thus be 0.|4 days per arm||||mmol/24 hours||Standard Deviation|Mean
1329241|NCT02111200|Primary|Urinary Hippuric Acid|The objective of this protocol is to directly compare the efficacy of benzoate, phenylbutyrate and a combination of the two, to conjugate nitrogenous compounds in healthy volunteers. The nitrogenous compound of interest in each arm would be based on the medication used. This would be hippuric acid in the benzoate arm, phenylacetylglutamine in the phenylbutyrate arm, and hippuric acid AND phenylacetylglutamine in the MIX arm. The mean hippuric acid levels in the phenylbutyrate arm would thus be 0.|4 days per arm||||mmol/24 hours||Standard Deviation|Mean
1329242|NCT02111174|Secondary|Number of Patients Who Stopped Using Neuroleptics at 28 Days|This will be assessed by concomitant medication review by a study team member during the 10 days of treatment. Follow-up was assessed as participant self-report over the last 10 days; all opiates were further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.|28 days post-intervention|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||Participants|||Count of Participants
1329243|NCT02111174|Secondary|Number of Patients Who Stopped Using Opioids at 28 Days|This will be assessed by concomitant medication review by a study team member during the 10 days of treatment. Follow-up was assessed as participant self-report over the last 10 days; all opiates were further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.|28 days post-intervention|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||Participants|||Count of Participants
1329244|NCT02111174|Secondary|Changes in Patient Reported Motor Outcomes at 3 Months|This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 3 months||||units on a scale||Standard Deviation|Mean
1329245|NCT02111174|Secondary|Changes in Patient Reported Motor Outcomes at 2 Months|This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 2 months||||units on a scale||Standard Deviation|Mean
1329246|NCT02111174|Secondary|Changes in Patient Reported Motor Outcomes at 28 Days|This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 28 days|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||units on a scale||Standard Deviation|Mean
1329247|NCT02111174|Secondary|Changes in Patient Reported Sensory Outcomes at 3 Months|This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 3 months||||units on a scale||Standard Deviation|Mean
1329248|NCT02111174|Secondary|Changes in Patient Reported Sensory Outcomes at 2 Months|This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 2 months||||units on a scale||Standard Deviation|Mean
1329249|NCT02111174|Secondary|Changes in Patient Reported Sensory Outcomes at 28 Days|This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 28 days|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||units on a scale||Standard Deviation|Mean
1329250|NCT02111174|Secondary|Change in Pain at 3 Months as Measured by the Modified Brief Pain Index|To determine the change in pain from day 0 to 3 months (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.|Change from baseline to 3 months||||units on a scale||Standard Deviation|Mean
1329251|NCT02111174|Secondary|Change in Pain at 2 Months as Measured by the Modified Brief Pain Index|To determine the change in pain from day 0 to 2 months (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.|Change from baseline to 2 months||||units on a scale||Standard Deviation|Mean
1334188|NCT02027402|Secondary|Operative Time||1day||||minutes||Standard Deviation|Mean
1329252|NCT02111174|Primary|Change in Pain as Measured by the Modified Brief Pain Index at 28 Days|To determine the change in pain from day 0 to day 28 (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.|Change from baseline to 28 days|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||units on a scale||Standard Deviation|Mean
1329253|NCT02111096|Secondary|Number of Participants With Hypoglycemic Events|Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L), is presented. The number of subjects with an event are subjects who had at least one episode of documented symptomatic hypoglycemia during the time period.|Baseline through 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after study drug and/or starting rescue therapy.|||Participants|||Count of Participants
1329254|NCT02111096|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L),is presented. Rate: (30 days) is calculated as: (number of episodes during the time period divided by the number of days during the time period) multiplied by 30.|Baseline through 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||number of episodes per day|||Number
1329255|NCT02111096|Secondary|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021||Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,|All participants who received at least 1 dose of study drug and had evaluable PK data.|||Liters (L)||95% Confidence Interval|Number
1329256|NCT02111096|Secondary|Population Pharmacokinetics: Apparent Clearance of LY2409021|Reported as a Population Estimate with % Standard Errors of Estimation (SEE), 5th-95th confidence interval.|Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||Liters per hour (L/h)||95% Confidence Interval|Number
1329257|NCT02111096|Secondary|Change From Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)|7-point profile consists of pre-meal and 2-hour postprandial SMBG measurements for the morning, midday, and evening meals in 1 day and at 3 AM (nocturnal blood glucose measurement). Pre-meal measurements were taken before the subject began eating the meal. Participants recorded their glucose measurements in their study diaries.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||mg/dL||Standard Deviation|Mean
1329258|NCT02111096|Secondary|Change From Baseline to 6 Months in Pulse Rate|Seated pulse rate was measured in triplicate throughout the study. At each visit, all available pulse measurements for a subject were averaged to provide the pulse for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||beats per minutes (bpm)||95% Confidence Interval|Least Squares Mean
1329259|NCT02111096|Secondary|Change From Baseline to 6 Months in Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured in triplicate throughout the study. At each visit, all available blood pressure measurements for a subject were averaged to provide the blood pressure for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||millimeters of mercury (mm/Hg)||95% Confidence Interval|Least Squares Mean
1329260|NCT02111096|Secondary|Change From Baseline to 6 Months in Fasting Plasma Glucose|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug,have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||milligram per decililiter (mg/dL)||95% Confidence Interval|Least Squares Mean
1329261|NCT02111096|Secondary|Change From Baseline to 6 Months in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||percent of HbA1c||95% Confidence Interval|Least Squares Mean
1329262|NCT02111096|Secondary|Change From Baseline to 6 Months in Body Weight|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||kilograms (kg)||90% Confidence Interval|Least Squares Mean
1329263|NCT02111096|Secondary|Change From Baseline to 6 Months in Fasting Blood Glucagon|Glucagon values assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||picomol per liter (pmol/L)||95% Confidence Interval|Least Squares Mean
1334189|NCT02027402|Primary|Complication|complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.|2 weeks||||participants|||Number
1329264|NCT02111096|Secondary|Change From Baseline to 6 Months in Fasting Lipids Levels|Lipid values (cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of randomized study drug, have data at baseline and at least 1 post-baseline time point.|||millimol per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1329265|NCT02111096|Secondary|Frequency of Hepatobiliary Adverse Events of Special Interest (AESI)|Number of participants with ALT or AST greater than 3 times the upper limit of normal at a post-baseline visit. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1329266|NCT02111096|Secondary|Change From Baseline to 6 Months in Alanine Aminotransferase Levels|Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, baseline data and at least 1 post-baseline time point.|||microgram per Liter (µ/L)||95% Confidence Interval|Least Squares Mean
1329267|NCT02111096|Primary|Change From Baseline to 6 Months in Hepatic Fat Fraction|The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have usable MRI HFF data at baseline and at least 1 post-baseline time point, excluding any data collected after stopping study drug.|||percentage||95% Confidence Interval|Least Squares Mean
1329268|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Curve(AUC)||Zero to infinity [AUC(0-∞)]|All participants who had at least one study treatment and had evaluable PK data.|||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1329269|NCT02111083|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.|||hours||Geometric Coefficient of Variation|Geometric Mean
1329270|NCT02111083|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.|||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
1329271|NCT02111083|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|Day1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacodynamic(PD) data.|||grams (g)||Geometric Coefficient of Variation|Geometric Mean
1329272|NCT02111083|Secondary|Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PK data.|||hours||Full Range|Median
1329273|NCT02111083|Primary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)||Day 1, predose through 8 hours post dose in each period|All participants who had at least one study treatment and had evaluable PK data.|||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1329274|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1329275|NCT02110693|Secondary|Cannabis Positive Oral Fluid Test|Positive Oral Fluid Cannabis testing.|baseline|Adult Primary Care Patients with oral fluid test results|||Spearman Correlation|||Number
1329276|NCT02110693|Secondary|Smokeless Tobacco Questionnaire|Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.|baseline|Adult Primary Care patients|||Spearman Correlation||95% Confidence Interval|Number
1329277|NCT02110693|Secondary|Cigarette Smoking Risk|Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.|baseline|Adult Primary Care patients|||Spearman Correlation||95% Confidence Interval|Number
1329278|NCT02110693|Secondary|Risky Alcohol Use|Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).|Baseline|Adult Primary Care Patients|||Spearman Correlation||95% Confidence Interval|Number
1329279|NCT02110693|Secondary|Unhealthy Cannabis Use|The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use|Baseline||||Spearman Correlation||95% Confidence Interval|Number
1329280|NCT02110693|Secondary|High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)|The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
1329281|NCT02110693|Primary|Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|adult primary care patients|||Sensivity||95% Confidence Interval|Number
1329283|NCT02110693|Primary|Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
1329284|NCT02110693|Primary|Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care population|||Sensitivity||95% Confidence Interval|Number
1329285|NCT02110693|Primary|Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
1329286|NCT02110381|Secondary|Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)|Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.|8 weeks||||Participants|||Count of Participants
1329287|NCT02110381|Secondary|Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)|Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.|8 weeks||||Participants|||Count of Participants
1329288|NCT02110381|Primary|Change in Blood Pressure|Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.|8 weeks and 16 weeks|9 subjects in each group were analyzed. These subjects represent the individuals who passed started the intervention phase of the study.|||mmHg (millimeters of mercury)||Standard Deviation|Mean
1329289|NCT02110277|Secondary|Pathologic Diagnosis and in Vivo Imaging|To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging.|5 years|0 participants analyzed since study was terminated prematurely.||||||
1329290|NCT02110277|Primary|To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb|To develop a method of analyzing PAI ovarian tissue images measuring oxy and deoxy hemoglobin as well as the ratio of deoxy/oxy Hb to recognize the presence of ovarian abnormalities and compare changes seen with ultrasound to changes seen with PAI.|5 years|Study prematurely terminated and no results analyzed.||||||
1329291|NCT02110238|Primary|WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.|Change from Baseline (CFB) over Weeks 3, 6, and 12|Per Protocol: All subjects with at least 1 post baseline primary outcome measure and no important protocol deviations.|||millimeter||95% Confidence Interval|Least Squares Mean
1329292|NCT02110147|Secondary|Patients With Levels of Uridine in the Plasma Consistent With Expected Therapeutic Benefit|HOA is principally a chronic uridine deficiency disorder. The purpose of uridine triacetate administration is to provide an exogenous source of uridine. Therefore, plasma uridine levels were assessed at various time points (prior to dosing, 30 min, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours) following uridine triacetate dosing to ensure levels of uridine consistent with previously observed symptomatic improvement from administration of uridine were achieved. The table below shows the number of participants with uridine levels consistent with or exceeding previously observed symptomatic improvements.|Days 1 and 28||||Participants|||Count of Participants
1329293|NCT02110147|Secondary|Patients With Stable or Improved Orotic Acid and Orotidine Levels|Significantly elevated urine orotic acid levels are characteristic of patients with HOA. Therefore, urinary orotic acid and orotidine levels were assessed in patients at baseline (on uridine or uridine naïve) and on Day 28 and Day 42 following the switch to uridine triacetate. The table below shows the number of participants with stable or improved orotic acid and orotidine levels at Day 28 and Day 42 compared to baseline.|Days 28 and 42||||Participants|||Count of Participants
1329294|NCT02110147|Primary|Patients With Stable Predetermined Principal Hematologic Parameters|Hereditary orotic aciduria patients will be taking uridine triacetate as replacement therapy for uridine. The primary outcome measure will be based on predetermined principal hematologic parameter(s) based on the patient's response(s) to oral uridine when dosing is switched from oral uridine to oral uridine triacetate. The primary outcome measure in patients not previously receiving uridine replacement therapy will be improvement in the patient's principal affected hematologic parameter(s) on Days 28 and 42 compared to baseline (Day 0) of the Main Study.|Days 28 and 42||||Participants|||Count of Participants
1329295|NCT02109731|Primary|Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG)|The pre-study AHI (before the NAP treatment was applied) was measured and quantified and compared to the post study AHI (after three months of NAP treatment) and the difference between pre and post therapy is reported. The AHI is an hourly rate of breathing disturbance (apneas and hypopneas per hour) that is calculated while subjects are evaluated during an overnight sleep study, with polysomnography applied (PSG). For example, while a subject is spending the night in the PSG laboratory sleeping, his/her breathing is evaluated for evidence of apneas and hypopneas during various stages of sleep. Sleep is measured with electroencephalography. And breathing is measure with respiratory excursions via chest/abdominal plethysmography recordings and airflow from the nose/mouth.|three months|subjects with a diagnosis of OSA|||events per hour||Standard Deviation|Mean
1329324|NCT02109445|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
1329296|NCT02109640|Secondary|Pain Scores|"Overall Benefit of Analgesia Score (OBAS): Score range 0-28 with low score=high benefit. Summed from subscales of 0-4 for the following questions:~Please rate your current pain at rest on a scale between 0⁄4 minimal pain and 4⁄4 maximum imaginable pain~Please grade any distress and bother from vomiting in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from itching in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from sweating in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from freezing in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from dizziness in the past 24 h (0⁄4 not at all to 4⁄4 very much)~How satisfied are you with your pain treatment during the past 24 h (0⁄4 not at all to 4⁄4 very much) Lehmann N. British Journal of Anaesthesia 105 (4): 511–18 (2010)"|Postoperative day 3||||units on a scale||Full Range|Median
1329297|NCT02109640|Secondary|Total Opioid Analgesia Consumption|Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant|Total postoperative period of analgesic consumption, an average of 1 week||||milligram morphine equivalents||Standard Deviation|Mean
1329298|NCT02109640|Primary|Prevalence of Postoperative Gut Dysfunction|The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation.|Day 3 post-op||||Participants|||Count of Participants
1329299|NCT02109497|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event||Up to 19 days after first dose of caffeine|Safety population|||participants|||Number
1329300|NCT02109497|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg|PK Per Protocol Population, as defined as all participants who received scheduled doses of both caffeine and PBT2 and had sufficient samples collected to determine PK parameters from plasma concentrations of caffeine on Day 1 and Day 12.|prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48 hours post each dose.||||ng*hr/mL||Standard Deviation|Mean
1329301|NCT02109484|Secondary|Rotavirus Shedding After Administration of Rotarix in Infants Receiving 3 Doses of Vaccine or Placebo.|Percent of infants who shed rotavirus at any timepoint after receiving 3 doses of study vaccine and one dose of Rotarix. Infants received Rotarix vaccination beginning on Day 84. Stool specimens were collected from these infants on the 5th, 7th and 9th day following first administration of Rotarix. This test was performed as a novel functional assessment of the ability to suppress local gut multiplication of the vaccine strain contained in Rotarix.|Rotarix vaccination on Day 84 to day 91||||Participants|||Count of Participants
1329302|NCT02109484|Primary|Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8])|Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.|Baseline to Day 84|Enrolled infants who received placebo, 10 mcg, 30 mcg or 60 mcg V2-VP8.|||Participants|||Count of Participants
1329303|NCT02109484|Primary|Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses|Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.|Baseline to day 84||||Participants|||Count of Participants
1329304|NCT02109484|Primary|Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse.|Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third vaccination). Confidence intervals are displayed as percentages.|Baseline to day 84|Enrolled infants who received 3 vaccinations and with pre and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
1329305|NCT02109484|Primary|Number of Participants Reporting Any Non-Serious Adverse Event|all adverse events will be recorded over the duration of the 6 month follow up period.|6 mo following first vaccination||||Participants|||Count of Participants
1329306|NCT02109484|Primary|Number of Participants With Serious Adverse Events|Number of participants experiencing a Serious Adverse Event within 28 days of a vaccination and at any time during the study|within 28 days of a study dose and at any time|All subjects that received at least one dose of P2-VP8 vaccine or placebo|||Participants|||Count of Participants
1329307|NCT02109484|Primary|Number of Participants With Vaccine Induced Reactions|Maximum severity of all local reactions or systemic reactogenicity after any vaccination|7 days following each dose||||Participants|||Count of Participants
1329308|NCT02109458|Secondary|Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB|Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.|Approximately 1 week upon receipt of pathology report||||participants|||Number
1329309|NCT02109458|Secondary|Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone|Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.|Approximately 1 week upon receipt of pathology report||||participants|||Number
1329310|NCT02109458|Primary|Incidence of Pneumothorax|Presence of pneumothorax assessed in participants with successful completion of biopsy.|Immediately after procedure||||participants|||Number
1329311|NCT02109458|Primary|Feasibility|Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)|Immediately following procedure||||participants|||Number
1330269|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1329312|NCT02109445|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30) - Phase 2|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline till end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.||||||
1329313|NCT02109445|Secondary|Change From Baseline in European Quality of Life Questionnaire (EQ-5D) - Phase 2|EQ-5D: 6-item participant rated questionnaire to assess health-related quality of life in terms of a single utility score. There were 2 components: a Health State Profile and a Visual Analog Scale. Published weights are available that allow for the creation of a single summary score. Overall scores range from 0-1, with low scores representing a higher level of dysfunction.|Baseline till end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.||||||
1329314|NCT02109445|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score - Phase 2|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Day 1 of Cycle 1 and subsequent cycles; end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.||||||
1329315|NCT02109445|Secondary|Progression-free Survival (PFS) in Phase 2|PFS was defined as the time from the date of first dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date – date of randomization +1) divided by 30.4.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for PFS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for PFS.||||||
1329316|NCT02109445|Secondary|1-year and 2-year OS in Phase 2|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS.||||||
1329317|NCT02109445|Secondary|Duration of Response (DR) for Phases 1 and 2|Duration of response (DR) defined as the difference in days between the first date criteria for progression occurred or the participant died due to any cause and the first date that criteria for a PR or CR were met. DR calculated as (months) = (progression/death date - first date of OR + 1) divided by 30.4. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 8 weeks until disease progression or unacceptable toxicity (up to 5 years)|No participants were analyzed for this outcome measure as there were no participants with OR in Phase 1 and Phase 2 was not done.||||||
1329318|NCT02109445|Secondary|Number of Participants With Objective Response (OR) in Phase 2|"Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Screening till 28-35 days post last administration of study drug|No participants were analyzed for this outcome measure as Phase 2 was not done.||||||
1329319|NCT02109445|Secondary|Number of Participants With Objective Response (OR) in Phase 1|"Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Screening till 28-35 days post last administration of study drug|All enrolled participants in Phase 1 who were eligible for enrollment, received study treatment, had measurable disease and adequate baseline assessments, and had at least 1 on-study tumor assessment, were considered evaluable for response. Only 1 participant was evaluable for OR in Phase 1.|||participants|||Number
1329320|NCT02109445|Secondary|Plasma Decay Half-life (t1/2) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
1329321|NCT02109445|Secondary|Plasma Decay Half-life (t1/2) for Nab-P and GEM in Phase 1||Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||hours||Standard Deviation|Mean
1329322|NCT02109445|Secondary|Volume of Distribution at Steady State (Vss) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
1329323|NCT02109445|Secondary|Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1||Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||liters||Geometric Coefficient of Variation|Geometric Mean
1329325|NCT02109445|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1||PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||hours||Full Range|Median
1329326|NCT02109445|Secondary|Systemic Clearance (CL) of PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
1329327|NCT02109445|Secondary|Systemic Clearance (CL) of Gemcitabine in Phase 1||Cycle 1 Days 1 and 15|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||liter (L)/minute (min)||Geometric Coefficient of Variation|Geometric Mean
1329328|NCT02109445|Secondary|Systemic Clearance (CL) of Nab-paclitaxel in Phase 1||Cycle 1 Days 1-3, and 15-17|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||liter (L)/hour (hr)||Geometric Coefficient of Variation|Geometric Mean
1329329|NCT02109445|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
1329330|NCT02109445|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1||PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1329331|NCT02109445|Secondary|Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 2|AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau), and AUC from time 0 to last measured concentration (AUClast).|Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
1329332|NCT02109445|Secondary|Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1|AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau, tau=12 hours), and AUC from time 0 to last measured concentration (AUClast).|PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the pharmacokinetic (PK) parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1329333|NCT02109445|Secondary|Number of Participants With Worsening QTc Results in Phase 2|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4.|Screening, Cycle 1 Days 1 and 22, Cycles 2 and 3 Day 1, end of treatment|Due to early termination, Phase 2 was not performed and thus no participants were analyzed for this outcome measure.||||||
1329334|NCT02109445|Secondary|Number of Participants With Worsening QTc Results in Phase 1|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4.|Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment|All enrolled participants in Phase 1 who had at least 1 ECG assessment after receiving PF-03084014.|||participants|||Number
1329335|NCT02109445|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Phases 1 and 2|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate, weight and body surface area.|Baseline up to 28-35 days after treatment discontinuation|All enrolled participants in Phase 1, or all randomized participants in Phase 2, who received at least 1 dose of study medication. Due to early termination of the study, vital sign evaluations were not performed.||||||
1329336|NCT02109445|Secondary|Number of Participants With Laboratory Abnormalities in Phase 2|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]).|Screening; Days 1, 8, 15 of each cycle; up to 28-35 days post last administration of study drug|Due to early termination, Phase 2 was not performed and thus no participants were included in this analysis.||||||
1329351|NCT02109107|Secondary|Change in Body Weight|Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.|Baseline and 6 weeks||||pounds||Standard Deviation|Mean
1329337|NCT02109445|Secondary|Number of Participants With Laboratory Abnormalities in Phase 1|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]).|Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug|All participants who received any study treatment.|||participants|||Number
1329338|NCT02109445|Secondary|Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 2|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening.|Baseline up to 28-35 days post last administration of study drug|No participants were analyzed since Phase 2 was not performed.||||||
1329339|NCT02109445|Secondary|Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening.|Baseline up to 28-35 days post last administration of study drug|All enrolled participants in Phase 1 who received at least 1 dose of study medication.|||participants|||Number
1329340|NCT02109445|Primary|Overall Survival (OS) in Phase 2|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS.||||||
1329341|NCT02109445|Primary|Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1|DLT was defined as any of the following events occurring during the first cycle of treatment and considered at least possibly-related to study medication: any Grade 3 or 4 clinically-relevant non-hematologic and/or hematologic toxicity, delay of more than 2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities.|Cycle 1 (28 days)|All enrolled participants who received study treatment and who either experienced DLT during the first cycle, or completed the 1-cycle observation period, were considered evaluable for DLT. Only 2 of the 3 participants were evaluable for DLTs.|||participants|||Number
1329342|NCT02109172|Primary|Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)|Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.|Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose||||mL||Standard Error|Least Squares Mean
1329343|NCT02109159|Secondary|Number of Access to the Video Generated as a Result of Video Sharing by Each Participant|The distribution of the numbers of access to the video that each participant generated will be compared using the data collected with the computer programme to track access to the videos.|After 14 days of sending the online videos||||Number of views||95% Confidence Interval|Mean
1329344|NCT02109159|Primary|Number of Participants Who Forwarded the Video|A computer programme to track the access to the videos has been made. The number of people who forwarded the video will be analysed based on the data collected with this programme.|After 14 days of sending the online videos||||participants|||Number
1329345|NCT02109133|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 24hours after operation||||participants|||Number
1329346|NCT02109133|Other Pre-specified|Post-operative Nausea||During 24hours after operation||||events|||Number
1329347|NCT02109133|Secondary|Overall Surgical Condition|overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.|At the end of the Steep trendelenburg position, an average of 1 hour||||units on a scale||Inter-Quartile Range|Median
1329348|NCT02109133|Primary|Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade|maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade|Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position||||mmHg||Standard Deviation|Mean
1329349|NCT02109107|Secondary|Subject Satisfaction With Study Outcome Rating|At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?”, using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied|6 weeks||||participants|||Number
1329350|NCT02109107|Secondary|Change in Body Mass Index (BMI)|Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.|Baseline and 6 weeks||||kg/m2||Standard Deviation|Mean
1329418|NCT02108171|Other Pre-specified|Patients With Postoperative Shivering in Two Groups|Patients With postoperative shivering in Two Groups. the occurrence of postoperative shivering|1 day||||participants|||Number
1329352|NCT02109107|Primary|Change in Combined Circumference Measurements|"Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success.~A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success."|Baseline and 6 weeks||||inches||Standard Deviation|Mean
1329353|NCT02109042|Primary|PK: Area Under the Concentration Curve of Blosozumab|The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.|Predose and daily up through 7 days postdose|Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.|||picomoles times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
1329354|NCT02109042|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab|The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.|Predose and daily up through 7 days postdose|Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.|||picomoles per milliliter||Geometric Coefficient of Variation|Geometric Mean
1329355|NCT02108977|Primary|Cost Analysis|Labor (including training) and non-labor (e.g., equipment cost) inputs required to provide counseling via telephone versus videoconferencing. Patient travels costs will be included via self-report.|Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)|Travel distance data not applicable to the Teleconferencing group.|||Loss of Productivity Cost in US Dollars||Inter-Quartile Range|Median
1329356|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS|Five counselors agreed to be interviewed. We asked them to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within 4 weeks after study data collection was completed|||||||
1329357|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS|We asked the subjects to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within six weeks of receiving genetic counseling|A subsample of patients in each modality was interviewed to qualitatively assess the satisfaction with the counseling they received, and the benefits and limitations of the modality, whether it was by phone or video.|||participants|||Number
1329358|NCT02108977|Primary|Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale|6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5)|Within two weeks of receiving genetic counseling||||points on a scale of 30 (most satisfied)||Standard Deviation|Mean
1329359|NCT02108977|Primary|Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment|Subjects will be asked 8 True/False genetics-related questions before and after counseling to assess improvement and retention of genetic counseling knowledge and information|Pre- and post- (within 2 weeks) genetic counseling||||Number of correct answers (out of 8)||Standard Deviation|Mean
1329360|NCT02108951|Secondary|Mean M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML)|"Quality of life was assessed using the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) self-administered questionnaire for adult CML patients. The questionnaire consisted of 13 core questions in part I measuring the severity of symptoms, 6 questions in part 2 assessing the interference of symptoms on daily living. The CML component of the MDASI provided an additional 7 CML-specific symptom items: diarrhea, swelling, rash/skin change, muscle soreness/cramping, bruising/bleeding easily, malaise, and headache. In part I (13 questions) and the CML component (7 questions) each question was scored from 0 to 10 where 0 indicates a symptom is not present and 10 indicate the symptom is as bad as you can imagine. For part 1 the total score can therefore range from 0 to 130 and for CML 0 to 70. Part 2 is also recorded on a 0 to 10 scale, but 0 now indicates that the symptom “did not interfere” and 10 “interfered completely”. The total score can range from 0 to 60."|Baseline, week 12, 24, 48, 96|The full analysis set (FAS) consists of all patients enrolled into the study. 'n' in the categories represents the number of patients with evaluable data for MDASI part 1/MDASI part 2/CML component at different time points. Week 96 includes end of study results for patients that did not complete the study.|||units on a scale||Standard Deviation|Mean
1329361|NCT02108951|Secondary|Number of Patients With Events Reported at Baseline That Have Shown an Improvement in Non-hematological AE Severity Compared to Week 12 Visit|The total number of patients that have showed improvement with respect to CTCAE grades at the time of the 12-week visit are reported. Improved is defined as prior to, or at the time of the 12-week visit, the AE has completely resolved.|Baseline, week 12 (month 3)|The Safety Set (SS) consisted of all patients in the FAS who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
1329362|NCT02108951|Secondary|Time to Event Free Survival (EFS)|"EFS was defined as the time from date of baseline visit to the first occurrence of any of the following: Disease progression, treatment failure or death from any cause, whichever was earlier. Patients who did not have an event of interest were censored at earliest of the following:~the date of the 24-month visit;~the date of loss to follow-up;~the date of withdrawal from the study for any reason other than lack of efficacy/progressive disease, tolerance to reduced dose or death"|96 weeks (24 months)|There were no patients in the study who were recorded as experiencing treatment failure.||||||
1329419|NCT02108171|Other Pre-specified|Patients With Postoperative Vomiting in Two Groups|Patients With postoperative vomiting in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day||||participants|||Number
1329420|NCT02108171|Other Pre-specified|Patients With Postoperative Nausea in Two Groups|Patients With postoperative nausea in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day||||participants|||Number
1329363|NCT02108951|Secondary|Time to Progression-free Survival (PFS)|"PFS was defined as the time from the date of baseline visit to the date of earliest progression-defining event: namely progression (or withdrawal due to progression to blast crisis (BC) or accelerated phase (AP) disease), or death from any cause.~Patients who did not progress were censored at earliest of the following:~the date of the 24-month visit;~the date of loss to follow-up;~the date of discontinuation of study treatment for any reason other than progression to BC, or AP disease, or death"|96 weeks (24 months)|The FAS consists of all patients enrolled into the study. There were no withdrawals due to progression to BC or AP disease, and there were no recorded deaths during the study.||||||
1329364|NCT02108951|Secondary|Kaplan-Meier Estimates of Time to Deep Molecular Response (MR4.5)|"Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels is measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy. MR4.5 corresponds to a~BCR-ABL ratio 0.0032% IS using RQ-PCR. The derivation of time to molecular response for patients in the study was measured from the date of first nilotinib use, defined as follows:~Days to MR4.5 = date of assessment where BCR-ABL ratio is 0.0032% IS - date of baseline + 1."|96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. N represents all patients in FAS who achieved MR4.5.|||days||95% Confidence Interval|Median
1329365|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MR4.5 Based on BCR-ABL Over Time After the Switch to Nilotinib|MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set. n = number of patients with evaluable data at the defined time point|||percentage of patients|||Number
1329366|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MR4.0 Based on BCR-ABL Over Time After the Switch to Nilotinib|MR4.0 corresponds to a BCR-ABL ratio 0.01% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set|||percentage of patients|||Number
1329367|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MMR Based on BCR-ABL Over Time After the Switch to Nilotinib|MMR corresponds to a BCR-ABL ratio 0.1% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72 and 96|Full analysis set. n = number of patients with evaluable data at the defined time point|||percentage of patients|||Number
1329368|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With no Response Based on BCR-ABL Over Time After the Switch to Nilotinib|No response corresponds to a BCR-ABL ratio < 0.1% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set. n = number of patients with evaluable data at the defined time point|||percentage of patients|||Number
1329369|NCT02108951|Primary|Number of Patients With MR4.5 Response by Baseline BCR-ABL Response Level Within 24 Months|"Deep Molecular Response (MR4.5) rate is defined as the percentage of patients who have achieved a 4.5 -log reduction in Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels. BCR-ABL levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. 'n' in categories indicates patients achieved or did not achieve MR4.5 during 24 months|||Participants|||Count of Participants
1329370|NCT02108951|Primary|Duration of Prior TKI Therapy for Patients Based on MR4.5 Achievement Status Within 24 Months|"Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~Deep molecular response (MR4.5) rate was defined as the percentage of patients who have achieved a 4.5-log reduction (MR4.5) in BCR-ABL levels during the 24 months following the commencement of nilotinib therapy. MR4.5 corresponds to a BCR-ABL ratio 0.0032% IS using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.|||months||Standard Deviation|Mean
1329371|NCT02108951|Primary|Major Molecular Response (MMR) Rate: Percentage of Patients Who Have Achieved a 3 Log Reduction in BCR-ABL Levels Within 12 Months and 24 Months|Major Molecular Response (MMR) rate is defined as the percentage of patients who have achieved a 3 log reduction in BCR-ABL levels at 12 months and at 24 months following the commencement of nilotinib therapy. Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood at the 12 and 24 months following the commencement of nilotinib therapy. MMR corresponds to a BCR-ABL ratio 0.1% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 * the baseline Value, the patient will be classified as achieving a 1 log drop.|Baseline, 48 weeks (12 months), 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.Analysis of MMR was undertaken on the subgroup of the FAS that was not at MMR at baseline.|||Percentage of participants||95% Confidence Interval|Number
1329372|NCT02108951|Primary|Molecular Response (MR4.0) Rate: Percentage of Patients Who Have Achieved a 4.0-log Reduction in BCR-ABL Level Within 12 Months and 24 Months|"Molecular Response (MR4.0) rate is defined as the percentage of patients who have achieved a 4-log reduction in BCR-ABL levels at 12 months and 24 months following the commencement of nilotinib therapy. Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~MR4.0 corresponds to a BCR-ABL ratio 0.01% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patients were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 48 weeks (12 months), 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. Analysis of MR4.0 was undertaken on the subgroup of the FAS that was not at MR4.0 at baseline.|||Percentage of participants||95% Confidence Interval|Number
1329373|NCT02108951|Primary|Deep Molecular Response (MR4.5) Rate: Percentage of Patients Who Have Achieved a 4.5-log Reduction in BCR-ABL Level Within 24 Month|"Deep Molecular Response (MR4.5) rate is defined as the percentage of patients who have achieved a 4.5 -log reduction in Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels. BCR-ABL levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.|||Percentage of participants||95% Confidence Interval|Number
1329374|NCT02108691|Secondary|Changes in LDLc/HDLc|LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||ratio||Standard Deviation|Mean
1329375|NCT02108691|Secondary|Changes in Non-HDLc|Non-HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||mg/dl||Standard Deviation|Mean
1329376|NCT02108691|Secondary|Changes in LDLc|LDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||mg/dl||Standard Deviation|Mean
1329377|NCT02108691|Secondary|Changes in BMI(Body Mass Index)|BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||kg/m^2||Standard Deviation|Mean
1329378|NCT02108691|Secondary|Changes in Weight|Weight was measured in study visit 1(0 week)and visit 3(8 week).|8 weeks||||kg||Standard Deviation|Mean
1329379|NCT02108691|Secondary|Changes in Percent Body Fat|Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks||||percentage||Standard Deviation|Mean
1329380|NCT02108691|Primary|Changes in Body Fat Mass|Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks||||g||Standard Deviation|Mean
1329381|NCT02108652|Secondary|Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab||Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.|||percentage of participants|||Number
1329382|NCT02108652|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)|Cohort 2 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.|||mcg/mL||Standard Deviation|Mean
1329383|NCT02108652|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)|Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.|||microgram(s)/milliliter (mcg/mL)||Standard Deviation|Mean
1329384|NCT02108652|Secondary|Percentage of Participants Alive at 1-year||1-year|Cohort 2 ITT Population|||percentage of participants||95% Confidence Interval|Number
1329385|NCT02108652|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to the time of death from any cause on study.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
1329386|NCT02108652|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
1329387|NCT02108652|Secondary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population.|||percentage of participants||95% Confidence Interval|Number
1329388|NCT02108652|Secondary|PFS as Assessed by the Investigator According to Modified RECIST|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
1329389|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
1329480|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The heights of 41 adult patients receiving intranasal placebo|1 day||||cm|||Number
1329390|NCT02108652|Secondary|PFS as Assessed by the Investigator According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
1329391|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
1329392|NCT02108652|Secondary|Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
1329393|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
1329394|NCT02108652|Secondary|DOR as Assessed by the Investigator According to Modified RECIST|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
1329395|NCT02108652|Secondary|DOR as Assessed by the Investigator According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
1329396|NCT02108652|Secondary|Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
1329397|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population.|||percentage of participants||95% Confidence Interval|Number
1329398|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population included Intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 2 ITT population included all participants from Cohort 2 who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1329399|NCT02108288|Secondary|Tmax of Latanoprost Acid||Day 1 and Day 7||||min||Full Range|Median
1329400|NCT02108288|Secondary|Tmax of Carteolol||Day 1 and Day 7||||h||Full Range|Median
1329401|NCT02108288|Primary|Cmax of Latanoprost Acid||Day 1 and Day 7||||pg/mL||Standard Deviation|Mean
1329402|NCT02108288|Primary|Cmax of Carteolol||Day 1 and Day 7||||ng/mL||Standard Deviation|Mean
1329403|NCT02108223|Secondary|Implantation Rates|Implantation rate is the percentage of embryos which successfully undergo implantation|up to 9 months||||percentage of embryo implantation|||Number
1329404|NCT02108223|Secondary|Fertilization Rate|fertilization rate used to measure how many oocytes become fertilized by sperm cells|up to 9 month||||percentage of fertilized oocytes|||Number
1329405|NCT02108223|Secondary|Number of Mature Oocyte|median number of mature oocytes retrieved per participant|up to 9 month||||oocytes||Standard Deviation|Median
1329406|NCT02108223|Secondary|the Number of Oocytes Retrieved|median number of oocytes retrieved per participant|up to 9 month||||oocytes||Standard Deviation|Median
1329407|NCT02108223|Primary|Pregnancy Rate|percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)|Up to 9 month|In Group 1, transfer procedure could not be performed one patient. In Group 2, the cycle was cancelled in two patients. Oocyte could not be obtained in one patient during OPU. In other 2 patients, transfer couldn’t be done. In Group 3 transfer procedure could not be performed in one patient. The pregnancy rates per embryo transfer were calculated.|||percentage of pregnant participants|||Number
1329408|NCT02108171|Secondary|Perioperative Hypertonsion Episodes|Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.|1 day||||participant|||Number
1329409|NCT02108171|Secondary|Perioperative Hypotension Episodes|Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.|1 day||||participant|||Number
1329410|NCT02108171|Secondary|Perioperative Tachycardia Episodes|Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s.|1 day||||participant|||Number
1329411|NCT02108171|Secondary|Perioperative Bradycardia Episodes|Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s.|1 day||||participant|||Number
1329412|NCT02108171|Secondary|Number of Participants With Satisfaction Score <2|"Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU).~Satisfaction score <2 was considered to be better for the patient"|1 day||||participant|||Number
1329413|NCT02108171|Secondary|Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine|Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine.|1 day||||mmHg||Standard Deviation|Mean
1329414|NCT02108171|Secondary|Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine|"4-point anxiety score:~= combative~= anxious~= calm~= amiable. Anxiety score >2 was considered to be better for the preoperative patients."|1 day||||units on a scale||Inter-Quartile Range|Median
1329415|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Dexmedetomidine (DEX) Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day||||units on a scale|||Number
1329416|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Placebo Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day||||units on a scale|||Number
1329417|NCT02108171|Other Pre-specified|Patients With Intra-operative Awareness in Two Groups|Patients With intra-operative awareness in Two Groups. patients receiving intranasal placebo or dexmedetomidine|1 day||||participants|||Number
1329421|NCT02108171|Other Pre-specified|Number of Participants With VAS >50|Patients with postoperative analgesia in two groups. analgesic requests within 2 h after extubation were recorded. An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day||||Number of Participants with VAS >50|||Number
1329422|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group at Pre-induction|HR in the dexmedetomidine group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
1329423|NCT02108171|Other Pre-specified|HR in the Placebo Group at Pre-induction|HR in the placebo group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
1329424|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group Before Intranasal Drugs|HR in the dexmedetomidine group Before Intranasal Drugs . HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
1329425|NCT02108171|Other Pre-specified|HR in the Placebo Group Before Intranasal Drugs|HR in the placebo group Before Intranasal Drugs HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
1329426|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at extubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329427|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at extubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329428|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at emergence.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329429|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal placebo at emergence.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329430|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at return of spontaneous breathing.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329431|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal placebo at return of spontaneous breathing.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329432|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine on removal of operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329433|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo on removal of operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329481|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The weights of 40 adult patients receiving intranasal dexmedetomidine|1 day||||kg|||Number
1329434|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine before inserting operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329435|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo before inserting operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329436|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at tracheal intubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329437|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at tracheal intubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml–1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg–1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
1329438|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at extubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329439|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of propofol after intranasal placebo at extubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329440|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at emergence.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329441|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of propofol after intranasal placebo at emergence.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329442|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at return of spontaneous breathing.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329443|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal placebo at return of spontaneous breathing.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||ug/ml|||Number
1329444|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine on removal of operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329445|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo on removal of operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329446|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine before inserting operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329447|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo before inserting operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
1329448|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at tracheal intubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml–1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml–1 at 2-min intervals to maintain the Narcotrend index between ‘D0’ and ‘E1’ until the end of surgery."|1 day||||µg/ml|||Number
1329449|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal placebo at tracheal intubation.~Propofol was infused intraoperatively to a target-controlled infusion (TCI) plasma concentration of 2.5μg∙ml–1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml–1 at 2-min intervals to maintain the Narcotrend index between ‘D0’ and ‘E1’ until the end of surgery."|1 day||||µg/ml|||Number
1329450|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Dexmedetomidine|Time to extubation of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and extubation|1 day||||minutes|||Number
1329451|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Placebo|Time to extubation of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and extubation|1 day||||minutes|||Number
1329452|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Dexmedetomidine|Time to consciousness of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and consciousness.|1 day||||minutes|||Number
1329453|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Placebo|Time to consciousness of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and consciousness.|1 day||||minutes|||Number
1329454|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Dexmedetomidine|Time to spontaneous breathing of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day||||minutes|||Number
1329455|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Placebo|Time to spontaneous breathing of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day||||minutes|||Number
1329456|NCT02108171|Secondary|Number of Participants With Anxiety Score >2|"satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction.~Anxiety score >2 was considered to be better for the patient."|1 day||||participant|||Number
1329457|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Dexmedetomidine|Satisfaction scores of patients receiving intranasal dexmedetomidine. Satisfaction used a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day||||units on a scale|||Number
1329458|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Placebo|Satisfaction scores of patients receiving intranasal placebo. satisfaction was assessed using a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day||||units on a scale|||Number
1329459|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Anxiety score of Patients Receiving Intranasal dexmedetomidine at Pre-induction.~The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day||||units on a scale|||Number
1329460|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo at Pre-induction|Anxiety score of Patients Receiving Intranasal Placebo at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day||||units on a scale|||Number
1329461|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Anxiety score of Patients Receiving Intranasal dexmedetomidine Before Intranasal Drugs.~The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day||||units on a scale|||Number
1329462|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|Anxiety score of Patients Receiving Intranasal Placebo Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day||||units on a scale|||Number
1329463|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine After Extubation|"Modified OAA/S score of patients receiving intranasal dexmedetomidine after extubation.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
1329464|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo After Extubation|"Modified OAA/S score of patients receiving intranasal placebo After extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
1329465|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Modified OAA/S score of patients receiving intranasal dexmedetomidine at Pre-induction.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
1329466|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo at Pre-induction|"Modified OAA/S score of patients receiving intranasal placebo at Pre-induction.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
1329467|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal dexmedetomidine Before intranasal drugs Modified Observer’s Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
1329468|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal placebo Before intranasal drugs Modified Observer’s Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
1329469|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Dexmedetomidine|Duration of surgery of patients receiving intranasal dexmedetomidine. Duration from surgery beginning to anesthesia ending|1 day||||minutes|||Number
1329470|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Placebo|Duration of surgery of patients receiving intranasal placebo Duration from surgery beginning to anesthesia ending|1 day||||minutes|||Number
1329471|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Dexmedetomidine|Duration of anesthesia of patients receiving intranasal dexmedetomidine Duration from anesthesia intubation to anesthesia ending|1 day||||minutes|||Number
1329472|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Placebo|Duration of anesthesia of patients receiving intranasal placebo Duration from anesthesia intubation to anesthesia ending|1 day||||minutes|||Number
1329473|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Dexmedetomidine|Duration of minutes From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal dexmedetomidine surgical data of Patients Receiving Intranasal dexmedetomidine.|1 day||||minutes|||Number
1329474|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to anesthesia intubation of Patients Receiving Intranasal Placebo surgical data of patients receiving intranasal placebo|1 day||||minutes|||Number
1329475|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Dexmedetomidine|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal dexmedetomidine surgical data of patients receiving intranasal dexmedetomidine|1 day||||minutes|||Number
1329476|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to arrival at operating room of patients receiving intranasal placebo surgical data of patients receiving intranasal placebo|1 day||||minutes|||Number
1329477|NCT02108171|Other Pre-specified|Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine|"American Society of Anesthesiologists (ASA) status of patients receiving intranasal placebo or dexmedetomidine.~ASA I: No organic, physiologic, biochemical or psychiatric disturbance ASA II: A patient with mild systemic disease that results in no functional limitation.~ASA III: A patient with severe systemic disease that results in functional impairment.~ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund condition in a patient who is not expected to survive with or without the operation.~ASA VI: Declared brain death patient whose organs are being harvested for transplantation."|1 day||||participant|||Number
1329478|NCT02108171|Other Pre-specified|Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine|Baseline characteristics (sex)of patients receiving intranasal placebo or dexmedetomidine The sex of 81 adult patients receiving intranasal placebo or dexmedetomidine|1 day||||participants|||Number
1329479|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The heights of 40 adult patients receiving intranasal placebo|1 day||||cm|||Number
1329484|NCT02108171|Secondary|Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine|"Modified Observer’s Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine.~Modified Observer’s Assessment of Alertness/Sedation Scale:~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus."|1 days||||units on a scale||Inter-Quartile Range|Median
1329485|NCT02108171|Primary|Extubation Time After Intranasal Dexmedetomidine Premedication|The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration|1 days||||min||Standard Deviation|Mean
1329486|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||Percent change||Standard Error|Least Squares Mean
1329487|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||Percent change||Standard Error|Least Squares Mean
1329488|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A1 ITT population.|||percent change||Standard Error|Least Squares Mean
1329489|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1329490|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1329491|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1329492|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).|||percent change||Standard Error|Least Squares Mean
1329493|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1329494|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1329495|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1329496|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|mITT population.|||percentage of participants|||Number
1329497|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis|"Calculated LDL-C goal was defined as:~<100 mg/dL (2.59 mmol/L) for heFH or non-FH participants who had a history of documented congestive heart disease (CHD), or~<120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases (ischemic stroke, peripheral artery disease, chronic kidney disease or diabetes) or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.~Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in imputation model."|Up to Week 24|ITT population.|||percentage of participants|||Number
1329498|NCT02107898|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1329499|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1338206|NCT01965665|Primary|Change in Sepsis Rate|Patients will be assessed weekly for sepsis or until frame is removed.|weekly from baseline until frame removal, up to 16 weeks|Data not collected||||||
1329501|NCT02107898|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1329502|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
1329503|NCT02107898|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1329504|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
1329505|NCT02107898|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1329506|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
1329507|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1329508|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1329509|NCT02107898|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1329510|NCT02107703|Secondary|Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire|EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, Short Term Follow Up (Up To 31 Months)|All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-BR23 data at short term follow up for each BR23 items.|||Units on a scale||Standard Error|Least Squares Mean
1329511|NCT02107703|Secondary|Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, Short Term Follow Up (Up To 31 Months)|All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.|||units on a scale||Standard Error|Least Squares Mean
1329557|NCT02107092|Secondary|Proportion of Subjects With Average Serum Potassium Values ≤ 5.5 mmol/L|The proportions of subjects with average S-K values ≤ 5.5 mmol/L during Extended Dosing Study Days 8 to 337, inclusive|11 months|Entered Extended Dosing Phase, received study drug and had post baseline S-K values during the Extended Dosing Phase. The analysis population includes 121 subjects, where there is one subject who only had end-of-study post-baseline measurement and therefore was not presented in the participants analyzed.|||Proportion of Participants||95% Confidence Interval|Number
1329512|NCT02107703|Secondary|Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, End of Study (Up To 31 Months)|All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.|||mm||Standard Error|Least Squares Mean
1329513|NCT02107703|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20|Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20.|Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose|All randomized participants who received at least one dose of 150 mg study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 PK data.|||Nanograms*hour/milliliters (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1329514|NCT02107703|Secondary|Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, End of Study (Up To 31 Months)|All randomized participants who received at least one dose of study drug with a baseline and at least 1 post-baseline result.|||score on a scale||Standard Error|Least Squares Mean
1329515|NCT02107703|Secondary|Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])|Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.PD was at least a 20% increase in sum of the diameters of target lesions,with reference being the smallest sum on study and an absolute increase of at least 5 mm or unequivocal progression of non-target lesions,or 1 or more new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1329516|NCT02107703|Secondary|Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])|Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1329517|NCT02107703|Secondary|Duration of Response (DOR)|DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants with response.|||Months||95% Confidence Interval|Median
1329518|NCT02107703|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1329519|NCT02107703|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|From Date of Randomization until Death Due to Any Cause (Up To 80 Months)|All randomized participants. Censored participants: Abemaciclib=361.|||Months||95% Confidence Interval|Median
1330270|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1329520|NCT02107703|Primary|Progression-Free Survival (PFS)|PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants. Censored participants: Abemaciclib=224.|||Months||95% Confidence Interval|Median
1329521|NCT02107599|Secondary|Change in Scan Interpretation Reliability After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.~NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative~Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection||||Fleiss Kappa||95% Confidence Interval|Number
1329522|NCT02107599|Primary|Change in Reader Accuracy After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.~NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative~Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection||||Net Reclassification Index|||Number
1329523|NCT02107482|Secondary|Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12||12 weeks||||Percent Change in Target Lesion Pruritus||Standard Deviation|Mean
1329524|NCT02107482|Secondary|The Percentage of Change in Target Lesion Score||12 weeks||||percentage of change in TLS||Standard Deviation|Mean
1329525|NCT02107482|Primary|The Percentage of Lesions With a Clear or Almost Clear Rating (Target Lesion Score of 3 or Less) on Target Lesion Scoring at Week 12||12 weeks||||percentage of lesions changed|||Number
1329526|NCT02107443|Secondary|Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Caregiver Satisfaction With Communication About Age-related Issues.|We will compare the effect of the intervention on caregiver satisfaction (the modified health care climate questionnaire-age for the caregiver). Will apply linear mixed model methodology. The total caregiver-HCCQ scores will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. A 95% credible (“confidence”) interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each site.|At 4-6 weeks, 3 months and 6 months following the intervention||2018-10-31|10/2018||||
1329527|NCT02107443|Secondary|Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers.|Patient HRQoL will be assessed with the Functional Assessment Cancer therapy (FACT-G) and Caregiver HRQoL (burden) will be assessed with the Caregiver Reactions Assessment (CRA). We will include geriatric assessment impairment (at baseline and follow up) to evaluate if these influence patient-reported HRQoL differently in the intervention versus the usual care group. We will also compare whether the uptake of the geriatric assessment recommendations influences patient reported HRQoL and caregiver burden. Data from the intervention arm will be fit to a linear mixed model with the FACT-G or CRA as the outcome, number and percent (number implemented/number recommended) of interventions as the fixed effect, and National Cancer Institute Community Oncology Research Program (NCORP) site as a random effect independent of residual error. Analyses will be adjusted for treatment status.|At 4-6 weeks, 3 months and 6 months following the intervention||2018-10-31|10/2018||||
1329528|NCT02107443|Primary|Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified]|Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. HCCQ contains 7 questions, scale: 0-28. The higher the score the more satisfied the patients is with communication with their oncologists about age related concerns. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. 95% credible (“confidence”) interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each site.|Within 1-7 days of the baseline audio-recorded clinic consultation|"All baseline patients who were evaluable for this primary aim were included in this analysis.~Arm I patients excluded (2 patients withdrew, 19 patients with no HCCQ).~Arm II patients excluded (3 patients withdrew, 9 no HCCQ)."|||HCCQ total score||95% Confidence Interval|Least Squares Mean
1329529|NCT02107443|Primary|Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified]|A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. The geriatric assessment was used to define which age related topics discussed between patients and providers would be coded. Will apply linear mixed model methodology. The total number of conversations will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. A 95% credible (“confidence”) interval will be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using the Best Linear Unbiased Predictors (BLUP) of the mean response for each site.|Baseline|"All baseline patients who were evaluable for this primary aim were included in this analysis.~Arm I patients excluded because 2 withdrew, 1 expired, 4 no audio captured and 2 primary aim protocol violations.~Arm II patients excluded (3 withdrew, 1 no audio captured)."|||Number of Conversations||95% Confidence Interval|Least Squares Mean
1329530|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|12 months after surgery|||||||
1329531|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|6 months after surgery|||||||
1329532|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|3 months after surgery|||||||
1329533|NCT02107339|Secondary|Chronic Persistent Surgical Pain|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|One month after surgery|||||||
1329534|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postoperative day 3||||units on a scale||Inter-Quartile Range|Median
1329535|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|postoperative day 2||||units on a scale||Inter-Quartile Range|Median
1329536|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postopertive day 1||||units on a scale||Inter-Quartile Range|Median
1329537|NCT02107339|Secondary|Pain Scores Postoperative Day 3|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 72 hours after PACU admission||||units on a scale||Inter-Quartile Range|Median
1329538|NCT02107339|Secondary|Pain Scores on Postoperative Day 2|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 48 hours after PACU admission||||units on a scale||Inter-Quartile Range|Median
1329539|NCT02107339|Secondary|Pain Scores on Postoperative Day One|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores one day after PACU admission||||units on a scale||Inter-Quartile Range|Median
1329540|NCT02107339|Secondary|Pain Scores 2 Hours After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 120 minutes after PACU admission||||units on a scale||Inter-Quartile Range|Median
1329541|NCT02107339|Secondary|Pain Scores 1 Hour After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 60 minutes after PACU admission||||units on a scale||Inter-Quartile Range|Median
1329542|NCT02107339|Secondary|Pain Scores Postanesthesia Care Unit (PACU) Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|First 5 minutes after PACU arrival||||units on a scale||Inter-Quartile Range|Median
1329543|NCT02107339|Secondary|Hydromorphone Use Third 24 Hours||48-72 hours after surgery||||milligrams||Inter-Quartile Range|Median
1329544|NCT02107339|Secondary|Hydromorphone Use Second 24 Hours||24-48 hours after surgery||||milligrams||Inter-Quartile Range|Median
1329545|NCT02107339|Primary|Hydromorphone Use at 24 Hours||Use of hydromorphone at 24 hours||||milligrams||Inter-Quartile Range|Median
1329546|NCT02107313|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events||Up to 15 days after the first dose of PBT2|Safety Population, as defined as all participants who received at least one dose of study drug|||participants|||Number
1329547|NCT02107313|Primary|Area Under the Concentration-Time Curve (AUC 0-t)||prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose|PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters.|||h*ng/mL||Standard Deviation|Mean
1329548|NCT02107274|Secondary|Spirometric Values: Forced Vital Capacity (FVC)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), Iong acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)||||Litres||Standard Deviation|Mean
1329558|NCT02107092|Primary|Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L|The proportions of subjects with average serum potassium (S-K) values ≤ 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive|11 months|Entered Extended Dosing Phase, received study drug and had post baseline S-K values during the Extended Dosing Phase. The analysis population includes 121 subjects, where there is one subject who only had end-of-study post-baseline measurement and therefore was not presented in the participants analyzed.|||Proportion of Participants||95% Confidence Interval|Number
1329549|NCT02107274|Secondary|Spirometry Value; Forced Expiratory Volume at 1 Second (FEV1)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), long acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)||||Litres||Standard Deviation|Mean
1329550|NCT02107274|Secondary|Health Status: St George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire is to be administered at visits 3, 6 and 8 inclusive. It should be administered in a quiet room where the participant can answer the questions without interruption, prior to any other protocol related procedures|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)||||Units||Standard Deviation|Mean
1329551|NCT02107274|Primary|24 Hour Sputum Volume|Each participant must be instructed and enabled to collect 24 hour sputum volumes over the 24 hours prior to visits 3, 6 and 8, inclusive. As this is the primary endpoint of the study, it is critical that 24 hour sputum volumes are measured and recorded accurately, observing the following protocol: The subject should be given a sterile jar to collect the sputum, which has been weighed previously for convenience. Each jar will be labelled with subject name, start and finish time/date The collection should commence on rising in the morning and complete 24 hours later. Ensure that the sputum sample has minimal saliva in the collection Instruct subject to collect all sputum produced spontaneously or after coughing over a single daytime 24 hour period. The sample should come from the lungs and should not be salivary. Encourage subject not to swallow sputum, but to collect. Each 24 hour collection period should be as similar as possible in terms of physiotherapy and exercise regimens|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|A total of 90 subjects were recruited. Among them, 78 subjects fulfilled the inclusion criteria and were randomized. Only 68 subjects completed the study and were subjected for analysis. We targeted to recruit 80 subjects and a dropout rate of 20% was anticipated as stated in the protocol.|||gram||Standard Deviation|Mean
1329552|NCT02107196|Secondary|Evaluation of Rebound Effects|"Comparison between average abdominal pain intensity (worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain) and average stool consistency score (the patients reported Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea) during the 4-week RW presented as change to baseline.~The analysis only included the patients randomised to ibodutant in the 12-week treatment period and re-randomised to placebo for the 4-week RW period. Baseline was considered as the average abdominal pain intensity/stool consistency in the 2-week Run-in period."|4 weeks|modified RW population: only patients randomised to ibodutant in the 12-week treatment period and re-randomized to placebo for the 4-week RW period (excluding patients from one site, where a potential serious breach of GCP was reported, and another site, where disqualification proceedings against the Investigator were confirmed by FDA).|||units on a scale||Standard Deviation|Mean
1329553|NCT02107196|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||percentage of responders|||Number
1329554|NCT02107196|Secondary|Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly stool consistency responder if she meets the following criterion:~Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stool Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||percentage of responders|||Number
1329555|NCT02107196|Secondary|Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:~Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||percentage of responders|||Number
1329556|NCT02107196|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:~Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;~Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stoll Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The primary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||Percentage of Responders|||Number
1329595|NCT02107014|Primary|Change in Eotaxin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329559|NCT02107014|Primary|Change in Overall Fibromyalgia Symptoms From Baseline.|"Visual analog scale (0-100) anchored at no symptoms at 0 and worst possible symptoms at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score."|Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||units on a scale||Standard Error|Mean
1329560|NCT02107014|Primary|Change in Pain From Baseline.|"Visual analog scale (0-100) anchored at no pain at 0 and worst possible pain at 100. Improvement in pain would be indicated by a decrease in the score."|Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||units on a scale||Standard Error|Mean
1329561|NCT02107014|Primary|Change in IL-22 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329562|NCT02107014|Primary|Change in FaSL From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329563|NCT02107014|Primary|Change in GROa From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329564|NCT02107014|Primary|Change in Resistin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329565|NCT02107014|Primary|Change in Leptin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329566|NCT02107014|Primary|Change in PAI-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329567|NCT02107014|Primary|Change in PDGF-BB From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329568|NCT02107014|Primary|Change in ENA-78 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329569|NCT02107014|Primary|Change in VCAM-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329570|NCT02107014|Primary|Change in ICAM-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329571|NCT02107014|Primary|Change in BDNF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329572|NCT02107014|Primary|Change in M-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329573|NCT02107014|Primary|Change in FGF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329574|NCT02107014|Primary|Change in EGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329575|NCT02107014|Primary|Change in NGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329576|NCT02107014|Primary|Change in VEGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329577|NCT02107014|Primary|Change in VEGF-D From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329578|NCT02107014|Primary|Change in HGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329579|NCT02107014|Primary|Change in SCF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329580|NCT02107014|Primary|Change in PIGF-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329581|NCT02107014|Primary|Change in TNF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329582|NCT02107014|Primary|Change in TNF-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329583|NCT02107014|Primary|Change in IFN-γ From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329584|NCT02107014|Primary|Change in IFN-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329585|NCT02107014|Primary|Change in IFN-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329586|NCT02107014|Primary|Change in TGF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329587|NCT02107014|Primary|Change in TGF-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329588|NCT02107014|Primary|Change in CD40L From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329589|NCT02107014|Primary|Change in TRAIL From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329590|NCT02107014|Primary|Change in MIG From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329591|NCT02107014|Primary|Change in MCP-3 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329592|NCT02107014|Primary|Change in MCP-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329593|NCT02107014|Primary|Change in MIP-1β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329594|NCT02107014|Primary|Change in RANTES From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
1329626|NCT02106923|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin|Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1329627|NCT02106923|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin|Maximum measured concentration of metformin in plasma|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1329628|NCT02106923|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin|Maximum measured concentration of empagliflozin in plasma (Cmax).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1329629|NCT02106923|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1329630|NCT02106923|Primary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1329631|NCT02106923|Primary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1329632|NCT02106832|Primary|Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Days||95.1% Confidence Interval|Median
1329633|NCT02106832|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)|FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Liter||Standard Deviation|Mean
1329634|NCT02106832|Secondary|Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)|The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1329635|NCT02106832|Secondary|Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)|New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of participants|||Number
1329660|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)|||Percentage of subjects||95% Confidence Interval|Number
1329636|NCT02106832|Secondary|Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)|The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1329637|NCT02106832|Secondary|Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)|Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of participants|||Number
1329638|NCT02106832|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Count of Participants
1329639|NCT02106832|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Count of Participants
1329640|NCT02106832|Primary|Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Days||99.9% Confidence Interval|Median
1329641|NCT02106728|Secondary|Change in Caregiver Functioning|EDSIS measures impact of ED.Subscales:Nutrition:0-32;Guilt:0-20;Dysregulated Behaviour:0-28;Social Isolation:0-16;Total: 0-96.Higher scores mean more negative appraisals of caregiving.Scores are summed.2)FQ measures criticism in families. Subscales:Critical Comments: 10-40;Emotional over-involvement: 10-40;Total:20-80.Higher scores mean higher perceived criticism.Scores are summed.3)SPS measures perceived social support. Attachment:4-16;Social Integration:4-16;Reassurance of Worth:4-16;Reliable Alliance Guidance:4-16;Opportunity for Nurturance:4-16;Total:24-96.Higher scores indicate higher social support.Scores are summed.4)Devaluation of consumers and consumer families measures perceived discrimination and stigma. Two subscales are:devaluation of consumers(8-32);devaluation of consumer’s families (7-28).Higher scores indicate higher levels of perceived discrimination and stigma. Subscales are summed separately.5)BDI, scored from 0-63:higher scores indicate higher levels of depression|Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment||||units on a scale||Standard Deviation|Mean
1329642|NCT02106728|Primary|Change in Weight|Change in weight is measured to gauge if there has been a loss, gain, or maintenance.|Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)||||pounds||Standard Deviation|Mean
1329643|NCT02106728|Primary|Dropout|3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)|3 months post enrollment||||participants|||Number
1329644|NCT02106494|Secondary|Rate of No Emetic Episodes|To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
1329645|NCT02106494|Secondary|Overall Complete Control Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
1329646|NCT02106494|Secondary|Delayed Complete Control (CC) Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
1329647|NCT02106494|Secondary|Overall Complete Response Rate|To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
1329648|NCT02106494|Primary|Delayed Phase Complete Response (CR) Rate|Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
1329659|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 151 (one month before the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Percentage of subjects||95% Confidence Interval|Number
1329649|NCT02106403|Secondary|Overall Sensory Liking of Study Products|Overall sensory liking of the study products was assessed immediately, 3min, 5 min and 15 min after products application. The assessment was done on a 9 point categorical scale where 1= Dislike it extremely, 2= Dislike it very much, 3= Dislike it moderately, 4= Dislike it slightly, 5= Neither like it nor dislike it, 6= Like it slightly, 7= Like it moderately, 8= Like it very much, 9= Like it extremely.|Immediatey, 3 min, 5 min and 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
1329650|NCT02106403|Primary|Participant-perceived Cooling Sensation at 15 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application.|At 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
1329651|NCT02106403|Primary|Participant-perceived Cooling Sensation at 5 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application.|At 5 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
1329652|NCT02106403|Primary|Participant-perceived Cooling Sensation at 3 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application.|At 3 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
1329653|NCT02106403|Primary|Participant-perceived Cooling Sensation Immediately Post Product Application|The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling).|Immediately after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
1329654|NCT02106390|Secondary|Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)|A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect.|Throughout the whole study period (from Day 1 upto Day 331)|Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent & demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record|||Participants|||Count of Participants
1329655|NCT02106390|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.|From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)|Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent & demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record|||Participants|||Count of Participants
1329656|NCT02106390|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)|Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination|From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)|Analysis was performed on the Solicited Safety Set. The solicited safety set included all subjects who provide informed consent & provide demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the trial and received a subject ID and provided post vaccination solicited adverse events data|||Participants|||Count of Participants
1329657|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
1329658|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination (Day 301).|||Percentage of subjects||95% Confidence Interval|Number
1329856|NCT02104804|Secondary|The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)||Baseline to Average of Weeks 20 and 24|232 and 229 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 229 for this outcome measure respectively.|||mg/dL||95% Confidence Interval|Least Squares Mean
1329661|NCT02106390|Secondary|Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y|"Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.~For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was <4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4)."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
1329662|NCT02106390|Secondary|Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301).~This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups.~For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was <2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2)."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination (Day 301).|||Percentage of subjects||95% Confidence Interval|Number
1329663|NCT02106390|Secondary|Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y|Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301).|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301).|||Ratio||95% Confidence Interval|Geometric Mean
1329664|NCT02106390|Secondary|Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains|Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301).|At Day 331 (one month after fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301).|||Ratio||95% Confidence Interval|Geometric Mean
1329665|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y|Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
1329666|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination (Day 301).|||Percentage of subjects||95% Confidence Interval|Number
1329667|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y|Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Percentage of subjects||95% Confidence Interval|Number
1329668|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)|||Percentage of subjects||95% Confidence Interval|Number
1329669|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
1329693|NCT02106156|Primary|Percentage of Participants With End of Treatment (EOT) Response|EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.|||percentage of participants|||Number
1329670|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301).|||Percentage of subjects||95% Confidence Interval|Number
1329671|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Percentage of subjects||95% Confidence Interval|Number
1329672|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at baseline (day 1)|||Percentage of subjects||95% Confidence Interval|Number
1329673|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.|"Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 331 (One month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
1329674|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.|"Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301).|||Percentage of subjects||95% Confidence Interval|Number
1329675|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151).|||Percentage of subjects||95% Confidence Interval|Number
1329676|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline(Day 1)|||Percentage of subjects||95% Confidence Interval|Number
1329677|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.|"hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331).|||Titers||95% Confidence Interval|Geometric Mean
1329678|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.|"hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination(Day 301)|||Titers||95% Confidence Interval|Geometric Mean
1329679|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y|"hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151).|||Titers||95% Confidence Interval|Geometric Mean
1329680|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.|"hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)|||Titers||95% Confidence Interval|Geometric Mean
1329681|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination( Day 331).|||Titers||95% Confidence Interval|Geometric Mean
1329682|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination( Day 301).|||Titers||95% Confidence Interval|Geometric Mean
1329683|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Titers||95% Confidence Interval|Geometric Mean
1329684|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (day 1).|||Titers||95% Confidence Interval|Geometric Mean
1329685|NCT02106390|Primary|hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y|"hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs.~This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1329686|NCT02106390|Primary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains|"Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1329687|NCT02106156|Secondary|Percentage of Participants With the Most Frequent Concomitant Medications|Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.|At Baseline (Day 1)|Only main analysis set had evaluable data for this outcome measure.|||percentage of participants|||Number
1329688|NCT02106156|Secondary|Duration of Peginterferon Alfa-2a Therapy|Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.|||weeks||Full Range|Median
1329689|NCT02106156|Secondary|Percentage Cumulative Dose of Ribavirin Received|Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.|||percentage of cumulated dose||Full Range|Median
1329690|NCT02106156|Secondary|Percentage Cumulative Dose of Peginterferon Alfa-2a Received|Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.|||percentage of cumulated dose||Full Range|Median
1329691|NCT02106156|Primary|Percentage of Participants With Serious Adverse Drug Reactions (SADR)||Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.|||percentage of participants|||Number
1329692|NCT02106156|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.|||percentage of participants|||Number
1329694|NCT02106156|Primary|Percentage of Participants With Early Virologic Response (EVR)|EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.|At Week 12|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 12.|||percentage of participants|||Number
1329695|NCT02106156|Primary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.|At Week 4|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.|||percentage of participants|||Number
1329696|NCT02105987|Secondary|Number of Participants With Incidence of Genotypic and Phenotypic Resistance Meeting Confirmed Virologic Withdrawal Criteria Over 24 Weeks|Genotypic and phenotypic testing was conducted for participants who met the confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 c/mL any time after Day 1. The sample from the “suspected virologic withdrawal criterion” visit was tested for HIV-1 PRO and RT genotype and phenotype and HIV-1 integrase genotype and phenotype (i.e., the first of the two consecutive results >=400 c/mL). At the time of the data cut-off for this Week 24 analysis, no participants met the confirmed virologic withdrawal criteria over 24 weeks; therefore, the virologic analyses were not assessed.|Baseline and up to 24 weeks|Viral Genotypic and Phenotypic Populations: Comprised of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time confirmed virologic withdrawal criterion was met.||||||
1329697|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Glucose at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
1329698|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Soluble CD163 at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
1329699|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Insulin at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
1329700|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Homostat Model Assess of Insulin Resistance at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
1329701|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, D-Dimer at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
1329702|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, C-reactive Protein at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
1329703|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Percent||95% Confidence Interval|Geometric Mean
1329704|NCT02105987|Secondary|Percent Change From Baseline in Bone Marker Analytes at Week 24|Outcome Measure Description: Bone biomarkers analytes include bone specific alkaline phosphatase, osteocalcin, procollagen 1 n-terminal propeptide, type I collagen c-telopeptides and were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, age, sex (male or female), body mass index (BMI) (<25 kilogram per meter [kg/m] or >=25 kg/m), smoking status (never smoked or former smoker or current smoker), Baseline vitamin D (no vitamin D use at Baseline or vitamin D use at Baseline), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Percent||95% Confidence Interval|Geometric Mean
1329770|NCT02105467|Other Pre-specified|Percentage of Participants Achieving Sustained Virologic Response at 4 Weeks After the End of Treatment (SVR4)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR4 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 4 weeks after the end of all study therapy.|Week 16 (4 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.|||Percentage of participants||95% Confidence Interval|Number
1329705|NCT02105987|Secondary|Change From Baseline in Urine Albumin/Creatinine Ratio at Week 24|Renal markers included urine albumin/creatinine ratioand summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Gram per mole (G/mol) creatinine||95% Confidence Interval|Least Squares Mean
1329706|NCT02105987|Secondary|Change From Baseline in Urea at Week 24|Renal markers included urea and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1329707|NCT02105987|Secondary|Change From Baseline in GFR From Creatinine Adjusted Using MDRD Enzymatic Equation at Week 24|Renal markers included GFR from creatinine adjusted using modification of diet in renal disease (MDRD) enzymatic equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||mL/second/1.73 meter square||95% Confidence Interval|Least Squares Mean
1329708|NCT02105987|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) From Creatinine Adjusted Using CKD-EPI Equation at Week 24|Renal markers included GFR from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI) equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||mL/second||95% Confidence Interval|Least Squares Mean
1329709|NCT02105987|Secondary|Change From Baseline in Creatinine at Week 24|Renal markers included creatinine and summarized based on an observed case (OC) data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Micromoles per liter (umol/L)||95% Confidence Interval|Least Squares Mean
1329710|NCT02105987|Secondary|Change From Baseline in Treatment Satisfaction at Week 4 and Week 24|The HIV treatment satisfaction questionnaire (TSQ) is a 10 item self-reported scale. Individual item scores range from 6 (very satisfied) to 0 (very dissatisfied). The treatment satisfaction total score (range 0-60) is the sum of all the 10 individual items. The general satisfaction/Clinical subscale (range 0-30) is the sum of the 5 clinical items and the lifestyle/ease subscale (range 0-30) is the sum of the remaining 5 lifestyle items. Last observation carried forward (LOCF) were used for the analysis. If a participant had a missing value at Week 24, his previous non-missing available value while on the same treatment was carried forward (ie the Week 4 or withdrawal value is used in the Week 24 summary for participants in the ABC/DTG3TC with missing Week 24 value). Data were analyzed using an ANCOVA model with factors including treatment, Baseline score and stratification factor. Treatment group difference (ABC/DTG/3TC-cART) estimate and 95% CI were presented.|Baseline, Week 4 and Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Units on a scale||Standard Error|Mean
1329711|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Total Cholesterol/HDL Cholesterol Ratio) at Week 24|Change from Baseline for fasting lipid parameter total cholesterol/HDL cholesterol ratio. Adjusted mean is the estimated mean change from Baseline at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points.|||Ratio||95% Confidence Interval|Least Squares Mean
1329712|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24|Change from Baseline for each fasting lipid parameters included cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Adjusted mean is the estimated mean change from Baseline in each parameter at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1329785|NCT02105324|Secondary|Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period|Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.|5 days|All randomized participants who completed both periods of the study. Reported for the Bionic Pancreas period only.|||percentage of time||Standard Deviation|Mean
1329713|NCT02105987|Secondary|Number of Participants With AEs Leading to Withdrawal Over 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia.|Baseline and up to 24 weeks|Safety Population|||Participants|||Number
1329714|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent hematology toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population|||Participants|||Number
1329715|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent chemistry toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population|||Participants|||Number
1329716|NCT02105987|Secondary|Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS estimates the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population: all participants who received at least one dose of study drug.|||Participants|||Number
1329717|NCT02105987|Secondary|Number of Participants in the Virologic Non-response Category From the Snapshot Analysis at Week 24|Virologic non-responders were defined as the participants with a viral load >=50 c/mL in the Week 24 analysis window. Virologic non-response includes participants who had HIV-1 RNA >=50 c/mL, who discontinued for lack of efficacy, who discontinued for other reasons while not suppressed, data in window but not <50 c/mL, and who changed ART regimen at Week 24. Difference is calculated as the proportion on ABC/DTG/3TC - proportion on current ART regimen.|Week 24|ITT-E Population|||Participants|||Number
1329718|NCT02105987|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24|Change from Baseline in CD4+ cell counts were assessed at Baseline, Weeks 4, 8, 16 and 24. No imputation for missing data or premature discontinuation was performed and the observed values were used. Baseline value is defined as the last pre-treatment value observed. Change from Baseline was calculated as the observed value minus the Baseline value. The Week 24 data were summarized.|Baseline and Week 24|ITT-E Population. Only participants with non-missing CD4 data at Week 24 are included.|||Cells per cubic millimeter (cells/mm^3)||Inter-Quartile Range|Median
1329719|NCT02105987|Primary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm|The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a “virology first” hierarchy. Virologic Success (e.g., <50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use HIV-1 RNA data from the late switch phase, even if such data is within the Week 24 analysis window). A virologic failure occurs when a participant changes to their ART regimen (e.g., addition of other ARTs to the study-specified regimens, or switches in components of the current ART regimen).|Week 24|Intent-to-Treat Exposed (ITT-E) Population: all participants randomized to ABC/DTG/3TC and receive at least one dose of study drug or randomized to remain on current ART regimen and continue in the study past Day 1.|||Participants|||Number
1329720|NCT02105974|Secondary|Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation|Time to first on-treatment exacerbation was analysed using a Cox proportional hazards model with terms for treatment, reversibility status and percent predicted FEV1 at screening. Exacerbation of COPD is defined by a worsening of symptoms requiring additional treatment. Moderate COPD exacerbation is worsening symptoms of COPD that require treatment with antibiotics and/or systemic corticosteroids. Severe COPD exacerbation is worsening symptoms of COPD that require treatment with in-patient hospitalization. The number of participants with On-Treatment moderate or severe COPD exacerbations are presented.|From the start of double blind study medication until visit 7 (week 12)/Early withdrawal|ITT Population|||Participants|||Number
1329786|NCT02105324|Secondary|Number of Severe Hypoglycemic Events|A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study.|||severe hypoglycemic events|||Number
1331446|NCT02076243|Secondary|Median Progression Free Survival|every eight weeks will reassess efficacy by imaging and can continue treatment if no progression and expect will be up to an average 5 years|average 5 years|study terminated, results not collected||||||
1329721|NCT02105974|Secondary|Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 12 (Visit 7) each morning and prior prior to taking study medication (i.e., single-blind and double-blind study medication), supplemental medication (albuterol [salbutamol] if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) or oxitropium bromide (applicable sites in Japan) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Rescue-free 24-hour periods are defined as the 24-hour periods in which the rescue medication (albuterol [salbutamol]) was not used. The percentage of 24-hour periods are summarized for the entire treatment period (12 weeks). Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, reversibility status (stratum), baseline (week -1) and region.|BL (Week -1), Week 1 to Week 12|ITT Population, all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.|||Percentage of rescue-free periods||Standard Error|Least Squares Mean
1329722|NCT02105974|Primary|Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, reversibility status (stratum), BL, region, day, day by BL and day by treatment interactions.|Baseline to Day 84|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liter||Standard Error|Least Squares Mean
1329723|NCT02105961|Secondary|Change From Baseline in Mean COPD Assessment Test (CAT) Score|The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on CAT scale||Standard Error|Least Squares Mean
1329724|NCT02105961|Secondary|Change From Baseline in Mean Total St. George’s Respiratory Questionnaire (SGRQ) Score|The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ , designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores range from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product.Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on SGRQ scale||Standard Error|Least Squares Mean
1329725|NCT02105961|Secondary|Rate of COPD Exacerbations Requiring Emergency Department (ED) Visits and/or Hospitalizations (Hosp)|COPD exacerbations requiring an ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. This analysis was performed on the mITT population.|From randomization to Week 52|mITT Population|||Exacerbations requiring ED/hosp per year||95% Confidence Interval|Least Squares Mean
1329726|NCT02105961|Secondary|Time to First Moderate/Severe Exacerbation|Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis of time to first moderate/severe exacerbation was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.|From randomization to Week 52|mITT Population|||Percentage of participants||95% Confidence Interval|Number
1329727|NCT02105961|Primary|Rate of Moderate or Severe Exacerbations|Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the modified intent-to-treat (mITT) Population (all randomized participants who received at least one dose of study treatment).|From randomization to Week 52|mITT Population|||Moderate/severe exacerbations per year||95% Confidence Interval|Least Squares Mean
1329753|NCT02105636|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Best overall response (BOR) was defined as the best response designation, recorded between the date of randomization and the date of progression, as assessed by the investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response assessments will contribute to the BOR assessment. For participants who continue treatment beyond progression, the BOR was determined based on response assessments up to the time of initial RECIST 1.1 progression.|Randomization to disease progression or study drug is discontinued, whichever occurs first; Approximately 5 years||2019-09-30|09/2019||||
1329728|NCT02105948|Secondary|Change From Baseline in Mean CAT Score in the mITT Population|The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Participants with a Baseline and at least one post-Baseline assessment were included in the analysis. Mean change from Baseline in CAT score at Week 52 has been presented. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on CAT scale||Standard Error|Least Squares Mean
1329729|NCT02105948|Secondary|Change From Baseline in Mean Total SGRQ Score in the mITT Population|The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ, designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores ranges from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on SGRQ scale||Standard Error|Least Squares Mean
1329730|NCT02105948|Secondary|Rate of COPD Exacerbations Requiring ED Visit and/or Hosp in the mITT Population|COPD exacerbations requiring ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on mITT Population. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|From randomization to Week 52|mITT Population|||Exacerbations requiring ED/hosp per year||95% Confidence Interval|Least Squares Mean
1329731|NCT02105948|Secondary|Time to First Moderate/Severe Exacerbation in the mITT Population|Kaplan Meier estimates of the probability of a moderate/severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). The analysis was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|From randomization to Week 52|mITT Population|||Percentage of participants||95% Confidence Interval|Number
1329732|NCT02105948|Secondary|Change From Baseline in Mean COPD Assessment Test (CAT) Score in Participants in the High Stratum|The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.|Baseline and Week 52|mITT-H Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on CAT scale||Standard Error|Least Squares Mean
1329733|NCT02105948|Secondary|Change From Baseline in Mean Total St. George’s Respiratory Questionnaire (SGRQ) Score in Participants in the High Stratum|The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ, designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores ranges from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.|Baseline and Week 52|mITT-H Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on SGRQ scale||Standard Error|Least Squares Mean
1329734|NCT02105948|Secondary|Rate of COPD Exacerbations Requiring an Emergency Department (ED) Visit and/or Hospitalization (Hosp.) in Participants in the High Stratum|COPD exacerbations requiring an ED visit and/or hosp. occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on mITT-H Population.|From randomization to Week 52|mITT-H Population|||Exacerbations requiring ED/hosp per year||95% Confidence Interval|Least Squares Mean
1329735|NCT02105948|Secondary|Time to First Moderate/Severe Exacerbation in Participants in the High Stratum|Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis was performed on the mITT-H Population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.|From randomization to Week 52|mITT-H Population|||Percentage of participants||95% Confidence Interval|Number
1329736|NCT02105948|Primary|Rate of Moderate or Severe Exacerbations in the mITT Population|Moderate and severe exacerbations occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the mITT Population which comprised of all randomized participants who received at least one dose of trial medication. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|From randomization to Week 52|mITT Population|||Moderate/severe exacerbations per year||95% Confidence Interval|Least Squares Mean
1329857|NCT02104804|Secondary|Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%||At Week 24|229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||% of participants|||Number
1329737|NCT02105948|Primary|Rate of Moderate or Severe Exacerbations in Participants in the High Stratum|Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization ( >= 24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from investigational product by subjects who remained in the study, were included in the analysis. The analysis was performed on the mITT high stratum (mITT-H) Population which comprised of participants in the mITT Population (all randomized participants who received at least one dose of study treatment) with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior.|From randomization to Week 52|mITT-H Population|||Moderate/severe exacerbations per year||95% Confidence Interval|Least Squares Mean
1329738|NCT02105740|Secondary|Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)|Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.|The study was done with each patient in the first three consecutive weeks after randomization|Were allocated 24 cancer patients, aged between 40-70 years, of both genders, with depression and anxiety score ≥ 9 in Hospital Anxiety and Depression Scale (HADS). One patient of the control group left the research.|||units on a scale||Standard Deviation|Mean
1329739|NCT02105740|Primary|Change of Pain Score in the Visual Analogue Scale|Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.|The study was done with each patient in the first three consecutive weeks after randomization|24 cancer patients were allocated. They were aged between 40-70 years, of both genders, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS). One patient of the control group left the research.|||units on a scale||Standard Deviation|Mean
1329740|NCT02105701|Secondary|Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|24 weeks after the end of all study treatment (up to 40 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1329741|NCT02105701|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.|||Number of participants|||Number
1329742|NCT02105701|Primary|Number of Participants Experiencing Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.|||Number of participants|||Number
1329743|NCT02105701|Primary|Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|12 weeks after the end of all study treatment (up to 28 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1329744|NCT02105688|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24): Immediate Treatment Arm|Blood is drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 is defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method is used to construct 95% confidence intervals for the SVR24 rate. As pre-specified in the protocol, the Deferred Treatment Arm will not be included in the secondary efficacy analysis.|24 weeks after end of all therapy (Study Week 36)||2019-05-31|05/2019||||
1329745|NCT02105688|Primary|Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. For this study, the primary safety analysis compared the safety data in the Immediate Treatment Arm during the double-blinded treatment period to those of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period (up to 12 weeks)|APaT Population; all participants who received at least one dose of study treatment.|||percentage of participants|||Number
1329767|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|baseline||||units on a scale||Standard Deviation|Mean
1329768|NCT02105558|Primary|Number of Participants With Vaginal Birth After Cesarean (VBAC)||at the time of delivery||||Participants|||Count of Participants
1329746|NCT02105688|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. For this study, the primary safety analysis compared the safety data in the Immediate Treatment Arm during the double-blinded treatment period to those of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period plus first 14 follow-up days (up to 14 weeks)|All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.|||percentage of participants|||Number
1329747|NCT02105688|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12): Immediate Treatment Arm|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. As pre-specified in the protocol, the Deferred Treatment Arm was not included in the primary efficacy analysis.|12 weeks after end of all therapy (Study Week 24)|Modified FAS (mFAS): All randomized participants in the Immediate Treatment Arm receiving ≥1 dose of study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. Deferred Treatment Arm was not included in primary efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
1329748|NCT02105662|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)|FAS; all allocated participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1329749|NCT02105662|Primary|Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Treatment Period (up to 12 weeks)|APaT Population; all participants who received at least one dose of study treatment.|||percentage of participants|||Number
1329750|NCT02105662|Primary|Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Treatment Period plus first 14 follow-up days (up to 14 weeks)|All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.|||percentage of participants|||Number
1329751|NCT02105662|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.|12 weeks after end of all therapy (Study Week 24)|Full Analysis Set (FAS); all allocated participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1329752|NCT02105636|Other Pre-specified|Number of Participants With Death, Study Drug-Related Death, Serious Adverse Events (SAEs), and Study Drug-Related SAEs in All Treated Participants at Primary Endpoint|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Date of first dose of study drug to 30 days post last dose of study drug, approximately 18 months|All Treated Participants: All randomized participants who received at least one dose of study drug|||participants|||Number
1329769|NCT02105467|Secondary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks After the End of Treatment (SVR24)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR24 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 24 weeks after the end of all study therapy.|Week 36 (24 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.|||Percentage of participants||95% Confidence Interval|Number
1329754|NCT02105636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria), or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants without any on study tumor assessments and did not die were censored on their date of randomization. Participants who received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.|Randomization to disease progression or death, whichever occurs first; Approximately 5 years||2019-09-30|09/2019||||
1329755|NCT02105636|Primary|Overall Survival (OS) Rate in All Randomized Participants at Primary Endpoint|The overall survival rate is the probability that a participant will be alive at 3, 6, 9, and 12 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 3, 6, 9, and 12 months|All randomized participants|||percent probability of OS||95% Confidence Interval|Number
1329756|NCT02105636|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) occurred at 218 deaths.|From date of randomization to date of death, approximately 18 months|All randomized participants.|||months||95% Confidence Interval|Median
1329757|NCT02105558|Secondary|Time From Second Stage of Labor to Delivery|The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm).|from the second stage of labor to delivery (about 6 to 174 minutes)|Because 2 in the epidural arm and 6 in the CSE arm never dilated to 10cms and were c-sectioned, it was not possible to obtain this value for these 8 participants. For 1 in the epidural arm and 1 in the CSE arm, delivery time was not recorded and so the time from the second stage of labor to delivery could not be determined for these 2 participants.|||minutes||Standard Deviation|Mean
1329758|NCT02105558|Secondary|Time From Regional Anesthesia to Delivery||from regional anesthesia to delivery (about 86 - 1205 minutes)|For 2 participants in the CSE group, delivery time was not recorded and so the time from regional anesthesia to delivery could not be determined.|||minutes||Standard Deviation|Mean
1329759|NCT02105558|Secondary|Neonatal Outcome as Assessed by (APGAR) Score|Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.|5 minutes after birth||||units on a scale||Standard Deviation|Mean
1329760|NCT02105558|Secondary|Neonatal Outcome as Assessed by (APGAR) Score|Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.|1 minute after birth||||units on a scale||Standard Deviation|Mean
1329761|NCT02105558|Secondary|Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS)|Maternal Satisfaction was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of satisfaction.|24 hours after regional anesthesia|Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.|||units on a scale||Standard Deviation|Mean
1329762|NCT02105558|Secondary|Childbirth Experience as Assessed by a Visual Analogue Scale (VAS)|Childbirth experience was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a better childbirth experience.|24 hours after regional anesthesia|Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.|||units on a scale||Standard Deviation|Mean
1329763|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|24 hours after regional anesthesia|Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.|||units on a scale||Standard Deviation|Mean
1329764|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|60 minutes after regional anesthesia|Data for 1 participant in the epidural arm were not recorded.|||units on a scale||Standard Deviation|Mean
1329765|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|30 minutes after regional anesthesia||||units on a scale||Standard Deviation|Mean
1329766|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|15 minutes after regional anesthesia||||units on a scale||Standard Deviation|Mean
1329888|NCT02103855|Secondary|Number of Participants With Pancreas Transplant Rejection|Pancreas Rejection as measured by serum amylase, serum lipase.|1 year||||Participants|||Count of Participants
1329771|NCT02105467|Primary|Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 12 (end of Blinded Treatment)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.|||Percentage of participants|||Number
1329772|NCT02105467|Primary|Percentage of Participants Experiencing at Least One Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to Week 14 (14 days after the Blinded Treatment was completed)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.|||Percentage of participants|||Number
1329773|NCT02105467|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA <Lower Limit of Quantification (<15 IU/mL) 12 weeks after the end of all study therapy.|Week 24 (12 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.|||Percentage of participants||95% Confidence Interval|Number
1329774|NCT02105454|Secondary|Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy|SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
1329775|NCT02105454|Primary|Percentage of Participants Discontinuing Study Drug Due to an Adverse Event|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 12 weeks|All participants as treated population defined as all participants who received at least one dose of study medication.|||Percentage of participants|||Number
1329776|NCT02105454|Primary|Percentage of Participants Experiencing Adverse Events|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)|All participants as treated population defined as all participants who received at least one dose of study medication.|||Percentage of participants|||Number
1329777|NCT02105454|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
1329778|NCT02105324|Secondary|Percentage of Participants Using Pramlintide During the Usual Care Period|The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.|5 days|All participants who completed both periods of the study. Results are reported for the Usual Care period only.|||percentage of participants|||Number
1329779|NCT02105324|Secondary|Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period|The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.|5 days|All participants who completed both periods of the study. Results are reported for the Usual Care period only.|||percentage of participants|||Number
1329780|NCT02105324|Secondary|Number of Unscheduled CGM Sensor Changes|The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.|5 days|All randomized participants who completed both periods of the study.|||CGM sensor changes|||Number
1329781|NCT02105324|Secondary|List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution||5 days|Data was not collected and analyzed to this level of detail.||||||
1329782|NCT02105324|Secondary|Reliability Index|Reliability index was calculated as the percentage of time values were actually recorded by CGM.|Day 1, Days 1-5, and Days 2-5 in each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1329783|NCT02105324|Secondary|Change From Baseline in Body Weight|The change in body weight collected at Day 5 of each period relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.|5 days|All randomized participants who completed both periods of the study.|||kg||Standard Deviation|Mean
1329784|NCT02105324|Secondary|Percentage of Time Without CGM Monitoring Data|Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.|5 days|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1329787|NCT02105324|Secondary|Mean Nausea Index Score Using a Visual Analogue Scale (VAS)|Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores from Day 1 to Day 5 were calculated|Day 1, Days 1-5, and Days 2-5 in each period|All randomized participants who completed both periods of the study.|||cm||Standard Deviation|Mean
1329788|NCT02105324|Secondary|Number of Bionic Pancreas Local Infusion Site Reactions|Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||infusion site reactions|||Number
1329789|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Days 2-5|All randomized participants who completed both periods of the study.|||unscheduled infusion set changes|||Number
1329790|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Days 1-5|All randomized participants who completed both periods of the study.|||unscheduled infusion set changes|||Number
1329791|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Day 1|All randomized participants who completed both periods of the study.|||unscheduled infusion set changes|||Number
1329792|NCT02105324|Secondary|Carbohydrate Intake|Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was <80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study.|||g/kg/day||Standard Deviation|Mean
1329793|NCT02105324|Secondary|Daily Bolus Insulin Dose in the Bionic Pancreas Period|The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant’s body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).|Day 1 through Day 5|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||U/kg/day||Standard Deviation|Mean
1329794|NCT02105324|Secondary|Daily Basal Insulin Dose in the Bionic Pancreas Period|The bionic pancreas automatically adapted insulin dosing to each individual’s needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).|Day 1 through Day 5|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||U/kg/day||Standard Deviation|Mean
1329795|NCT02105324|Secondary|Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm|Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).|Day 1, Days 1-5, and Days 2-5 of each period|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||µg/kg/day||Standard Deviation|Mean
1329796|NCT02105324|Secondary|Insulin Total Daily Dose|Insulin total daily dose is reported in units per kilogram per day (U/kg/day).|11 days|All randomized participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
1329797|NCT02105324|Secondary|Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15–20 min was less than 3.9 mmol/L.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||grams of carbohydrate||Full Range|Median
1329798|NCT02105324|Secondary|Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||carbohydrate interventions||Full Range|Median
1329799|NCT02105324|Secondary|Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care|The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.|Day 1, Days 1-5, and Days 2-5 of the Usual Care Period|All randomized participants who completed both periods of the study.|||percentage of days|||Number
1329800|NCT02105324|Secondary|Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-5||||times below threshold||Standard Deviation|Mean
1329801|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <183 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
1329802|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <169 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
1329803|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <154 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
1329804|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of values||Standard Deviation|Mean
1329805|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dL (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dL (2.8 mmol/L).|Days 1 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of values||Standard Deviation|Mean
1329806|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Day 1|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).|Day 1 of each period|All randomized participants who completed both periods of the study.|||percentage of values||Standard Deviation|Mean
1329807|NCT02105324|Secondary|Mean Plasma Glucose Values|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
1329808|NCT02105324|Secondary|Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-5||||times below threshold||Standard Deviation|Mean
1329809|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <183 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
1329810|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <169 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
1329811|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <154 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
1329812|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1329813|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Days 1 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1329814|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Day 1|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL(2.8 mmol/L), < 70 mg/dL (3.9 mmol/L), 70-180 mg/dL (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Day 1 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1329815|NCT02105324|Secondary|Mean CGMG Values|Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.|Day 1 and Days 1-5 in each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
1329889|NCT02103855|Primary|Serum Creatinine at Year 1|Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.|1 year|4 subjects who completed 1 year of Belatacept were analyzed.|||mg/dl||Standard Deviation|Mean
1329816|NCT02105324|Primary|Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5|Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 through 5 was calculated.|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1329817|NCT02105324|Primary|Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5|Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
1329818|NCT02105285|Secondary|Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 8 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
1329819|NCT02105285|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
1329820|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration||||mmHg||Standard Error|Mean
1329821|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration||||mmHg||Standard Error|Mean
1329822|NCT02105285|Secondary|Intraocular Pressure at Week 8 Predose|"Comparison of each group in intraocular pressure at Week 8 Predose. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 Predose||||mmHg||Standard Error|Mean
1329823|NCT02105285|Primary|Decrease From Baseline in Intraocular Pressure at Week 8 Predose|"Comparison of each group in change from baseline in intraocular pressure. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group."|Baseline, Week 8 Predose||||mmHg||95% Confidence Interval|Mean
1329824|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
1329855|NCT02104804|Secondary|Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24||Baseline to 24 weeks|232 and 230 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||IU||95% Confidence Interval|Least Squares Mean
1329890|NCT02103855|Primary|Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)|Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept|Baseline and 1 year||||ml/min/1.73m2||Standard Deviation|Mean
1329825|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
1329826|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration||||mmHg||Standard Error|Mean
1329827|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration||||mmHg||Standard Error|Mean
1329828|NCT02105272|Secondary|Intraocular Pressure at Week 8 Predose|Comparison of each group in intraocular pressure at Week 8 Predose. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.|Week 8 Predose||||mmHg||Standard Error|Mean
1329829|NCT02105272|Primary|Decrease From Baseline in Intraocular Pressure||Baseline, week 8 predose||||mmHg||95% Confidence Interval|Mean
1329830|NCT02105116|Secondary|Progression Free Survival Probability for CR|Calculated using Kaplan-Meier estimation method. Corresponding 95% confidence interval will be provided. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study for failure to reach complete remission. Hence no outcomes are available.|At 2 years|||||||
1329831|NCT02105116|Primary|Response Rate, Determined by Duration of Complete Remission|Patients will be scored as being in continuous remission at 2 years or having relapsed sooner. Of the 6 patients enrolled, all were ineligible to enter the treatment phase of the study for failure to reach complete remission for allogenic treatment.|Up to 2 years|||||||
1329832|NCT02105116|Primary|Response Rate, Determined by Allogeneic Cell Therapy-related Mortality|Patients' response rate will be determined by allogeneic cell therapy-related mortality. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study for failure to reach complete remission. Hence no outcomes are available.|Up to 2 years|||||||
1329833|NCT02105116|Primary|Adverse Events Related to Experimental Therapy|"Patients will be observed for incidence of adverse events related to experimental therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.~Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study because of failure to reach complete remission. None of the enrolled patients received experimental therapy (allogeneic donor lymphocyte therapy). The one death occurred while receiving standard therapy prior to eligibility for experimental allogeneic therapy. The remained of patients were ineligible for experimental therapy because they did not obtain a complete remission after standard induction chemotherapy."|Up to 2 years|||||||
1329834|NCT02105012|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score|The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum|Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)|MITT|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1329835|NCT02105012|Secondary|Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA|Change from baseline in mean number of puffs of rescue Ventolin HFA|Baseline to Last 7 Days of Treatment|MITT|||Puffs/Day||95% Confidence Interval|Least Squares Mean
1329836|NCT02105012|Secondary|Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Baseline to Last 7 Days of Treatment Period|MITT|||Liters/min||95% Confidence Interval|Least Squares Mean
1329837|NCT02105012|Secondary|Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Baseline to Last 7 Days of Treatment Period|MITT|||Liters/min||95% Confidence Interval|Least Squares Mean
1329838|NCT02105012|Primary|Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period|Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.|Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)|Modified Intent to Treat Population (MITT)|||Liters||95% Confidence Interval|Least Squares Mean
1329839|NCT02104947|Secondary|Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial|"Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial.~Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|after the first vial of idarucizumab and before the start of second vial on Day1|Treated Set|||percentage||95% Confidence Interval|Median
1329840|NCT02104947|Secondary|Cmin,1 of Unbound Sum (Free) Dabigatran|Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.|Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial|The Pharmacokinetic Set (PKS): This analysis set was used for all PK analyses and was defined as all patients in the Treated Set who provided at least one PK data point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1329841|NCT02104947|Secondary|Time to Cessation of Bleeding (for Group A Only)|Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.|from the first infusion up to 24 hours after the last infusion on Day 1|Treated set with patients who stopped bleeding within 24 hours|||hours||95% Confidence Interval|Median
1329842|NCT02104947|Secondary|Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively|Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.|within 24 hours of surgery|Treated Set|||percentage of participants||95% Confidence Interval|Number
1329843|NCT02104947|Secondary|Duration of Reversal|Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.|from the first infusion up to 24 hours after the last infusion on Day 1|Treated Set|||hours||Standard Deviation|Mean
1329844|NCT02104947|Secondary|Reversal of aPTT and TT From Central Laboratory|"Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).~Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|from the end of the first infusion up to 4 hours after the last infusion on Day 1|Treated Set|||percentage||95% Confidence Interval|Median
1329845|NCT02104947|Primary|Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT|"Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.~Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).~Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|from the end of the first infusion up to 4 hours after the last infusion on Day 1|Treated Set|||percentage||95% Confidence Interval|Median
1329846|NCT02104895|Secondary|Excellent Cosmesis|Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects|5 years||||percentage of participants|||Number
1329847|NCT02104895|Secondary|Acute Skin Toxicity|"Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced Acute skin toxicity ≥ grade 2"|5 years||||percentage of participants|||Number
1329848|NCT02104895|Primary|Ipsilateral Breast Tumor Recurrence|"We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced Ipsilateral Breast Tumor Recurrence"|5-year||||percentage of participants|||Number
1329849|NCT02104830|Secondary|Duration From ANC Nadir to ANC < 2.0 x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
1329850|NCT02104830|Secondary|Neutropenia Duration, Any Grade||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
1329851|NCT02104830|Secondary|Low Level (Nadir) ANC x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||cells x 10^9/L||Standard Deviation|Mean
1329852|NCT02104830|Secondary|The Incidence of Severe Neutropenia (Grade 3-4)||16 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||participants|||Number
1329853|NCT02104830|Secondary|The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);||2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
1329854|NCT02104830|Primary|Duration of Neutropenia CTCAE Grade 4|The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).|3 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
1329891|NCT02103439|Secondary|Biochemical Response|Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy|12 weeks||||percentage of patients|||Number
1329858|NCT02104804|Secondary|Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test||Baseline to 24 weeks|215 and 211 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||mg/dL||95% Confidence Interval|Least Squares Mean
1329859|NCT02104804|Secondary|Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test||Baseline to 24 weeks|213 and 206 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||mg*min/dL||95% Confidence Interval|Least Squares Mean
1329860|NCT02104804|Primary|Change in HbA1c From Baseline to Week 24||Baseline to 24 weeks|229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||Percentage change||95% Confidence Interval|Least Squares Mean
1329861|NCT02104739|Secondary|Peak Forearm Blood Flow|Peak forearm blood flow via strain gauge venous occlusion plethysmography|6 hours after meal|Though 16 completed the exenatide, saxagliptin, and placebo arms, data is only reported for 15 because the study team was unsuccessful in collecting data for the first study patient. Data for the exenatide extended-release (ER) arm was only collected at baseline and 3 hours.|||mL per minute per 100mL of tissue||Standard Error|Mean
1329862|NCT02104739|Secondary|Peak Forearm Blood Flow|Peak forearm blood flow via strain gauge venous occlusion plethysmography|3 hours after meal|Though 16 completed the exenatide, saxagliptin, and placebo arms, data is only reported for 15 because the study team was unsuccessful in collecting data for the first study patient. Data for the exenatide extended-release (ER) arm was only collected at baseline and 3 hours.|||mL per minute per 100mL of tissue||Standard Error|Mean
1329863|NCT02104739|Secondary|Peak Forearm Blood Flow|Peak forearm blood flow via strain gauge venous occlusion plethysmography|baseline|Though 16 completed the exenatide, saxagliptin, and placebo arms, data is only reported for 15 because the study team was unsuccessful in collecting data for the first study patient. Data for the exenatide extended-release (ER) arm was only collected at baseline and 3 hours.|||mL per minute per 100mL of tissue||Standard Error|Mean
1329864|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|6 hours after meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
1329865|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|4 hours after meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
1329866|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|2 hours after meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
1329867|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|baseline|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
1329868|NCT02104739|Secondary|Triglycerides|triglycerides|6 hours after ingestion of meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
1329869|NCT02104739|Secondary|Triglycerides|triglycerides|4 hours after ingestion of meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
1329870|NCT02104739|Secondary|Triglycerides|triglycerides|2 hours after ingestion of meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
1329871|NCT02104739|Secondary|Triglycerides|triglycerides|baseline|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
1329872|NCT02104739|Primary|Monocyte NfkB Levels as Detected by Western Blotting|Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.|2 hours after ingestion of meal||||NfkB p65 arbitrary units||Standard Error|Mean
1329873|NCT02104739|Primary|Monocyte NfkB Levels as Detected by Western Blotting|Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.|baseline||||NfkB p65 arbitrary units||Standard Error|Mean
1329874|NCT02104505|Secondary|Mucociliary Clearance as Affected by Gamma Tocopherol|On day 11 of treatment (approximately 6 hours after the daily dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.|after 11 days of gamma tocopherol or placebo treatment|Due to the crossover study design, only participants who completed both arms of the study were included in the analysis.|||% of labeled particles cleared from lung||Standard Deviation|Mean
1329875|NCT02104505|Secondary|Mucociliary Clearance (MCC) Associated With CCRE Challenge as Affected by Gamma Tocopherol|On day 14 of treatment (approximately 6 hours after the final dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.|after 14 days of gamma tocopherol or placebo treatment|Due to the crossover design of the study, only participants who completed both arms of the study were included in the analysis.|||% of labeled particles cleared from lung||Standard Deviation|Mean
1329876|NCT02104505|Secondary|Chronic Eosinophilic Airway Inflammation as Affected by Gamma Tocopherol|The sputum eosinophils were measured at baseline (immediately prior to dosing) and again after 14 days of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare sputum eosinophils per mg before and after gamma tocopherol treatment.|after 14 days of gamma tocopherol or placebo treatment|Since this study employs a crossover design, only participants who completed both arms of the study were included in the final analysis.|||eosinophils per mg sputum||Standard Deviation|Mean
1330271|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1329877|NCT02104505|Primary|Comparison of Change in Sputum Percent Neutrophils (PMN)s Following Inhaled Clinical Center Reference Endotoxin (CCRE) Challenge as Affected by Gamma Tocopherol|In asthmatic individuals, exposure to CCRE is expected to increase PMNs in the sputum. The sputum PMNs were measured at baseline (immediately prior to dosing) and again on day 14 of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare the change in PMNs from baseline to post treatment after exposure to CCRE|after 14 days of gamma tocopherol or placebo treatment|Since this study employed a crossover design, only participants who completed both arms of the study were included in the analysis.|||change in percentage of PMNs in sputum||Standard Deviation|Mean
1329878|NCT02104427|Secondary|the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF|determine circulating CD34+ cell counts in peripheral blood|Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)|There were 5 patients who achived target number of CD34+ cells (>=5.0*10^6 cells/kg) within two leukapheresis sessions and therefore didn't undergo addtional sessions. Among 7 patients who undergone 6 sessions, there were 1 patient didn't collect blood sample at 4h, 6h post-infusion and post-leukapheresis, and 1 patient 6h post-infusion not done.|||cells/µL||Full Range|Median
1329879|NCT02104427|Secondary|Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions|The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥6.0 x 10^6 cells/kg was collected within 5 leukapheresis sessions. Each patient’s CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions.|Day 5 to Day 9|There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.|||Proportion of patients||95% Confidence Interval|Number
1329880|NCT02104427|Secondary|Proportion of Patients From Whom a Total Number of CD34+ Cells ≥2.5 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions|The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥2.5 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. Each patient’s CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.|Day 5 to Day 8|There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.|||Proportion of patients||95% Confidence Interval|Number
1329881|NCT02104427|Primary|Proportion of Patients From Whom a Total Number of CD34+ Cells ≥5.0 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions|The primary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥5.0 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. For the primary efficacy endpoint, each patient’s CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.|Day 5 to Day 8|There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.|||Proportion of participants||95% Confidence Interval|Number
1329882|NCT02104219|Other Pre-specified|Rickets Severity Sale - RSS|The RSS is a 10-point scale, developed for nutritional rickets, that evaluates the degree of metaphyseal cupping and fraying and the proportion of growth plate affected (10 points = severe cupping/fraying, 0 points = absence of cupping/fraying).|Any available data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment value during the period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.|||units on a scale||Inter-Quartile Range|Median
1329883|NCT02104219|Secondary|Change in Weight Z-score From Baseline to Last Assessment|Weight measurements were assigned a Z-score which was calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while Post baselines are time points after Baseline during the defined age period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.|||Z-score||Inter-Quartile Range|Median
1329884|NCT02104219|Secondary|Change in Height Z-score From Baseline to Last Assessment|Height measurements were assigned to Z-scores which were calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients’ aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while post baselines are time points after Baseline during the defined age period.||||Z-score||Inter-Quartile Range|Median
1329885|NCT02104219|Primary|Radiographic Global Impression of Change - RGI-C|The RGI-C scale is a 7-point ordinal scale that is used to evaluate musculoskeletal characteristics of HPP (eg, metaphyseal fraying, demineralization of distal metaphyses). The scores range from -3 (severe worsening) to +3 (complete or near-complete healing).|Between Baseline (earliest available, complete, and readable x-ray set) and all available, readable post-Baseline x-ray sets during the period of patients' aged 5 to 15 years, inclusive.|Patients diagnosed with juvenile-onset HPP.|||units on a scale||Inter-Quartile Range|Median
1329886|NCT02103855|Secondary|Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.|Fasting Serum Glucose level measured at 1 year after conversion from Tacrolimus to Belatacept.|1 Year|4 subjects who completed 1 year of Belatacept.|||mg/dl||Standard Deviation|Mean
1329887|NCT02103855|Secondary|Change From Baseline Serum Hemoglobin A1c|Pancreas Transplant Function was measured by assessing change in Pre HbA1c to Post HbA1c at1 year after conversion.|Baseline and 1 year||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1329892|NCT02103439|Primary|Early Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving early virologic response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks||||percentage of patients|||Number
1329893|NCT02103439|Secondary|Viral Breakthrough|Proportion of patients in each groups with level of Hepatitis C Virus ribonucleic acid > 15 IU/ml after Hepatitis C Virus ribonucleic acid was not present or Hepatitis C Virus ribonucleic acid was increased by more than 1log10 from baseline at 4 or 12 weeks of treatment|screening data and at 4 or 12 weeks of treatment.||||percentage of patients|||Number
1329894|NCT02103439|Secondary|Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving rapid virological response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks||||percentage of patients|||Number
1329895|NCT02103439|Secondary|Rapid Virological Response|Proportion of randomized patients achieving rapid virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks||||percentage of patients|||Number
1329896|NCT02103439|Primary|Early Virological Response|Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks||||percentage of patients|||Number
1329897|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)|The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. “Overall Vision” was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
1329898|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Handling and Overall Vision)|The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
1329899|NCT02103309|Secondary|Mean Investigator-Rated Lens Fit|Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
1329900|NCT02103309|Primary|Mean Investigator-Rated Lens Centration|Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
1329901|NCT02103114|Secondary|Length of Time to Delayed Sternal Closure Measured in Days|Study the safety profile of dosing the ATIII by monitoring the length of time to delayed sternal closure measured in days|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||days||Standard Deviation|Mean
1329902|NCT02103114|Secondary|Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage|Study the safety profile of dosing the ATIII by monitoring the incidence (number) of newly diagnosed intracranial hemorrhage|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||participants|||Number
1329903|NCT02103114|Secondary|Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria|"Study the safety profile of dosing the ATIII by monitoring the incidence of new onset renal failure, defined by stage 3 of the Acute Kidney Injury Network (AKIN) criteria.~Serum creatinine increase ≥26.5 μmol/l (≥0.3 mg/dl) or increase to 1.5–2.0-fold from baseline, urine output <0.5 ml/kg/h for 6 hours~Serum creatinine increase >2.0–3.0-fold from baseline, urine output <0.5 ml/kg/h for 12 hours~Serum creatinine increase >3.0-fold from baseline or serum creatinine ≥354 μmol/l (≥4.0 mg/dl) with an acute increase of at least 44 μmol/l (0.5 mg/dl) or need for Renal replacement therapy (RRT), urine output <0.3 ml/kg/h for 24 h or anuria for 12 hours or need for RRT"|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||count of participants|||Number
1329904|NCT02103114|Secondary|Incidence (Number) of Thrombotic Events Documented|Study the safety profile of dosing the ATIII by monitoring the incidence (number) of thrombotic events documented.|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||events|||Number
1329905|NCT02103114|Secondary|Incidence of Mediastinal Exploration Within 24 Hours Postoperatively|Study the safety profile of dosing the ATIII by monitoring the incidence of mediastinal exploration within 24 hours postoperatively|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||count of participants|||Number
1329906|NCT02103114|Secondary|Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively|Study the safety profile of dosing the ATIII by monitoring the incidence of extracorporeal membrane oxygenation (ECMO) support within 24 hours postoperatively.|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||number|||Number
1329907|NCT02103114|Secondary|Length of Post Operative Ventilation in Days|Length of post operative ventilation in days|ICU arrival (Time 5) to Time 7 (Post-Operative Day 4)||||days||Standard Deviation|Mean
1329908|NCT02103114|Secondary|Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively|Total Dose of rescue recombinant factor 7a (VIIa) used intraoperatively|Intraoperatively||||mcg||Standard Deviation|Mean
1329909|NCT02103114|Secondary|Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group|Number of total blood product units (including packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units) transfused 24 hours post-operatively for each group (not total units transfused for each subject)|24 Hours Post-Operatively||||Units|||Number
1329993|NCT02101112|Secondary|Relative Bioavailability (Frel) of Apixaban|Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet).|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ratio||Geometric Coefficient of Variation|Geometric Mean
1329910|NCT02103114|Secondary|Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group|Number of packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units transfused 24 hours post-operatively for each group (not total units transfused for each subject)|24 Hours Post-Operatively|Unable to be calculated accurately as blood products given in CPB prime were only designated in Units administered and not mls (no record of how many mls present in each unit). Therefore unable to back calculate total mls given from start of surgery to 24 hours postop|||Units|||Number
1329911|NCT02103114|Secondary|Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters|Chest Tube output (protamine time plus 24 hours) in milliliters|protamine time plus 24 hours||||milliters||Inter-Quartile Range|Median
1329912|NCT02103114|Secondary|Volume of Postoperative Blood Loss|Volume of postoperative blood loss from 10min post protamine administration to 24 hour post protamine administration- (ml/kg)|From 10min post protamine administration to 24 hour post protamine administration||||ml/kg||Standard Deviation|Mean
1329913|NCT02103114|Secondary|Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively|Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively|Baseline (Intraoperatively)||||count of participants|||Number
1329914|NCT02103114|Secondary|Total Volume of Fresh Frozen Plasma Given Prior to CPB|Total volume of Fresh Frozen Plasma given prior to CPB, including the pump prime (ml/kg)|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||ml/kg||Standard Deviation|Mean
1329915|NCT02103114|Secondary|Time From Protamine Administration to Skin Dressing|Time from protamine administration to skin dressing|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||minutes||Inter-Quartile Range|Median
1329916|NCT02103114|Secondary|Total Volume of Blood Products While on CPB|Total volume of blood products exposed intraoperatively including the pump prime (ml/kg)|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||mls||Standard Deviation|Mean
1329917|NCT02103114|Secondary|Protamine Dose Determined by Hemostasis Management System Machine (mg/kg)|Protamine dose determined by Hemostasis Management system machine (mg/kg)|T1 (Baseline) to T5 (Arrival in ICU)||||mg/kg||Inter-Quartile Range|Median
1329918|NCT02103114|Secondary|Total Dose of Heparin While on Cardiopulmonary Bypass|Total dose of Heparin while on Cardiopulmonary Bypass|T1 (Baseline) to T5 (Arrival in ICU)||||units||Inter-Quartile Range|Median
1329919|NCT02103114|Secondary|Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group|Evidence of decreased inflammation represented by a decrease in inflammatory markers in the ATIII group.|Baseline (T1) to Post-Operative Day 4 (T7)|Laboratory testing not performed.||||||
1329920|NCT02103114|Secondary|Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level.|Evidence of a decreased amount of residual heparin at the Intensive Care Unit arrival time point (T5) represented by a decreased anti factor Xa level.|T5 (Intensive Care Unit Arrival)|In both arms, heparin level was undetectable as Anti factor Xa level was less than or equal to 0.1 IU/ml in all subjects.|||International Units/milliter||Standard Deviation|Mean
1329921|NCT02103114|Secondary|Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the D dimer of the control and ATIII groups at T1 (Baseline), T5 (Arrival in Intensive Care Unit), T6 (Post-Operative Day 2) and T7 (Post-Operative Day 4).|T1, T5, T6 and T7||||mcg/ml||Inter-Quartile Range|Median
1329922|NCT02103114|Secondary|Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the ATIII (functional assay) of the control and ATIII groups at T4 (just prior to coming off of CPB). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage.|T4 (just prior to coming off of CPB)||||% Functional Activity||Inter-Quartile Range|Median
1329923|NCT02103114|Secondary|Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean of the ATIII (functional assay) of the control and ATIII groups at T1, T2, T3, T5, T6 and T7 (Baseline, 30 min after study drug, 30 min on CPB, Arrival in ICU, POD 2, and POD 4). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage.|T1, T2, T3, T5, T6 and T7||||% Functional Activity||Standard Deviation|Mean
1329924|NCT02103114|Secondary|Difference in the Mean and SD of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Times 5-Time 7 (ICU Arrival to Post Operative Day 4)|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and SD of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at times 5-Time 7 (ICU arrival to Post Operative Day 4)|ICU arrival (Time 5) to Time 7 (Post-operative Day 4)|The laboratory was unable to perform this blood assay due to technical difficulties and no results were generated.||||||
1329925|NCT02103114|Primary|Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in ICU)|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU).|Time 5 (on arrival in ICU)|The laboratory was unable to perform this blood assay due to technical issues and no results were generated.||||||
1329926|NCT02103062|Other Pre-specified|Kaplan Meier Estimate of PFS by Investigator Assessment|PFS was measured as time from the date of first dose to the date of disease progression according to RECIST 1.1 or death from any cause, whichever was earlier.|Up to 241 days|Intent-to-treat Population defined as participants who received treatment and met all eligibility criteria|||weeks||95% Confidence Interval|Median
1329994|NCT02101112|Secondary|Terminal Plasma Half-life (T-HALF) of Apixaban|Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body.|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||hours||Standard Deviation|Mean
1329927|NCT02103062|Secondary|Number of Participants With Adverse Events|A treatment emergent adverse events (TEAE) was defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and Severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Lifethreatening; Grade 5-Fatal;|Time of the first dose of study treatment to 28 days after the last dose of study drug; maximum treatment duration was 24 weeks|Safety population includes all participants who received at least one dose of study treatment|||participants|||Number
1329928|NCT02103062|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion was met to the date of disease progression based on investigational assessment following RECIST 1.1.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. Duration of response was not analyzed as there were no responders observed in the study.||||||
1329929|NCT02103062|Secondary|Percentage of Participants With Stable Disease for ≥ 8 Weeks, or Complete or Partial Response According to RECIST Version 1.1; Disease Control Rate (DCR)|DCR was defined as the combined incidence of stable disease confirmed CR or PR and stable disease (SD) measured at the Week 8 assessment or later.|At week 8 and later; up to day 241|ITT Population defined as participants who received treatment and met all eligibility criteria|||Percentage of participants||95% Confidence Interval|Number
1329930|NCT02103062|Secondary|Overall Response Rate (ORR)|"ORR was defined as the combined incidence of Complete Response (CR) and Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met based on RECIST 1.1. Tumor responses were assessed every 2 cycles using RECIST 1.1 and defined as:~Complete response-disappearance of all target lesions~Partial response- At least a 30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)~Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir."|Up to 241 days|ITT population defined as participants who received treatment and met all eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1329931|NCT02103062|Secondary|Overall Survival|Overall Survival was the time from the first dose of study drug to patient death from any cause.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. The study was stopped early and the analysis of overall survival was not performed.||||||
1329932|NCT02103062|Primary|Progression Free Survival (PFS) Rate as Measured at Week 8|PFS rate was measured by Investigator Assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the start of study treatment to disease progression or death from any cause, whichever occurred first.|At week 8 assessment period; up to 56 days|Per the Simon 2-stage design, only 30 participants from Stage 1 (the first 15 participants in the Intent to Treat (ITT) population from each cohort) were included. The ITT population was defined as those who received treatment and met all eligibility criteria; four ineligible participants were excluded based on the protocol deviations/violations|||percentage of participants||95% Confidence Interval|Number
1329933|NCT02102932|Secondary|AUC(0-tz) of Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
1329934|NCT02102932|Secondary|AUC(0-tz) of Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
1329935|NCT02102932|Primary|Cmax for Metformin|Maximum measured concentration of the metformin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1329936|NCT02102932|Primary|Cmax for Empagliflozin|Maximum measured concentration of the empagliflozin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1329937|NCT02102932|Primary|AUC(0-∞) for Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
1331447|NCT02076243|Primary|Response Rate|the percentage of subjects who develop Complete Response (CR) or Partial Response (PR)|at week 8 post treatment|study terminated, results not collected||||||
1329938|NCT02102932|Primary|AUC(0-∞) for Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
1329939|NCT02102490|Secondary|Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score|EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Cycle 6 Day 1|All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data.|||Participants|||Count of Participants
1329940|NCT02102490|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20|Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20|Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose|All enrolled participants who received at least one dose of study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 pharmacokinetic (PK) data.|||Nanograms*hour/milliliters (ng*h/mL)]||Geometric Coefficient of Variation|Geometric Mean
1329941|NCT02102490|Secondary|Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Cycle 6 Day 1|All randomized participants with a baseline and at least 1 post-baseline mBPI-sf data.|||Participants|||Count of Participants
1329942|NCT02102490|Secondary|Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)|Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1329943|NCT02102490|Secondary|Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])|Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1329944|NCT02102490|Secondary|Progression Free Survival (PFS)|PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)|All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=35.|||Months||95% Confidence Interval|Median
1329945|NCT02102490|Secondary|Duration of Response (DOR)|DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.|From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1329995|NCT02101112|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Time of maximum observed plasma concentration (Tmax) measured in hours (h)|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||hours||Full Range|Median
1329946|NCT02102490|Secondary|Overall Survival (OS)|OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|From Date of First Dose until Death Due to Any Cause (Up To 27 Months)|All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=70.|||Months||95% Confidence Interval|Median
1329947|NCT02102490|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1329948|NCT02102464|Other Pre-specified|Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month|Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). The mean change in comfortable contact lens wear time from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month.|1 Month|Intent to Treat (all randomized subjects)|||hours per day|Eyes|95% Confidence Interval|Mean
1329949|NCT02102464|Other Pre-specified|Mean Change in Dry Eye Questionnaire From Baseline at 1 Month|The mean change in dry eye symptoms from Baseline based on the SPEED questionnaire score was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|1 Month|Intent to Treat (All randomized subjects)|||units on a scale|Eyes|95% Confidence Interval|Mean
1329950|NCT02102464|Other Pre-specified|Mean Change in Meibomian Gland Score From Baseline at 1 Month|The mean change in meibomian gland score from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving crossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.|1 Month|Intent to Treat (All randomized subjects)|||units on a scale|Eyes|95% Confidence Interval|Mean
1329951|NCT02102464|Other Pre-specified|Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months|Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). A pre-specified exploratory analysis was to compare the mean change in comfortable contact lens wear time between Baseline and 3 Months for the LipiFlow group vs. untreated control.|3 Months|Intent to Treat (ITT) of all randomized subjects|||hours per day||95% Confidence Interval|Mean
1329952|NCT02102464|Secondary|Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months|The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|3 Months|Intent to Treat (ITT) Population of all randomized subjects.|||units on a scale||95% Confidence Interval|Mean
1329953|NCT02102464|Primary|Mean Change in Meibomian Gland Score From Baseline at 3 Months|The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.|3 Months|Intent to Treat (ITT) Population of all randomized subjects.|||units on a scale|Eyes|95% Confidence Interval|Mean
1330022|NCT02100670|Secondary|Time of Onset of Meaningful Pain Relief (TOMR)|TOMR was measured by time when participants reported PRS ≥ 2, i.e. “some” or “meaningful” pain relief|up to 10 days (end of study)|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
1329954|NCT02102399|Secondary|Post-treatment Questionnaire (Compliance With Intervention)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their degree of compliance on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). It was considered compliance the answers moderate and a lot in comparison of not at all/somewhat, considered as no compliance. The results were presented in frequency/percentage of subjects in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of subjects|||Number
1329955|NCT02102399|Secondary|Post-treatment Questionnaire (Easier to Talk)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of subjects|||Number
1329956|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Clearer)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of subjects|||Number
1329957|NCT02102399|Primary|Change in GNE|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||Decibel (dB)||Standard Deviation|Mean
1329958|NCT02102399|Primary|Change in Noise|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||Decibel (dB)||Standard Deviation|Mean
1329959|NCT02102399|Primary|Change in Shimmer|Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%|Baseline, 6 weeks||||percentage of shimmer||Standard Deviation|Mean
1329960|NCT02102399|Primary|Change in Jitter|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||percentage of jitter||Standard Deviation|Mean
1329961|NCT02102399|Primary|Change in Fundamental Frequency|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||Hertz (Hz)||Standard Deviation|Mean
1329962|NCT02102399|Primary|Change in Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||units on a scale||Standard Deviation|Mean
1329963|NCT02102399|Primary|Acoustic Analysis (GNE) 2|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
1329964|NCT02102399|Primary|Acoustic Analysis (Noise) 2|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
1329965|NCT02102399|Primary|Acoustic Analysis (Shimmer) 2|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.~Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of shimmer||Standard Deviation|Mean
1329966|NCT02102399|Primary|Acoustic Analysis (Jitter) 2|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of jitter||Standard Deviation|Mean
1329967|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency) 2|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Hertz (Hz)||Standard Deviation|Mean
1329968|NCT02102399|Primary|Voice Handicap Index (VHI-10) 2|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||units on a scale||Standard Deviation|Mean
1329969|NCT02102399|Primary|Acoustic Analysis (GNE)|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
1329970|NCT02102399|Primary|Acoustic Analysis (Noise)|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
1329971|NCT02102399|Primary|Acoustic Analysis (Shimmer)|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.~Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of shimmer||Standard Deviation|Mean
1329972|NCT02102399|Primary|Acoustic Analysis (Jitter)|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of jitter||Standard Deviation|Mean
1329973|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Symptoms Improvement)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of participants|||Number
1329974|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency)|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Hertz (Hz)||Standard Deviation|Mean
1329975|NCT02102399|Primary|Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||units on a scale||Standard Deviation|Mean
1329976|NCT02102204|Secondary|Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies|The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).|Baseline and every 6 months (up to 24 months)|Participants who received at least 1 dose of etelcalcetide in the current study with a post-baseline antibody result during this study|||participants|||Number
1329977|NCT02102204|Secondary|Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters|The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.|Baseline to end of treatment; median duration of treatment was 563 days.|Participants who received at least 1 dose of etelcalcetide in the current study (20130213).|||participants|||Number
1329978|NCT02102204|Secondary|Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL|"The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.~If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula:~cCa (mg/dL) = total calcium (mg/dL) + (4 – albumin [g/dL])*0.8. If serum albumin was > 4.0 g/dL no correction was made."|From day 1 to months 6, 12, and 18|Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at the beginning of the time interval.|||percentage of participants||95% Confidence Interval|Number
1329979|NCT02102204|Secondary|Percentage of Participants With Serum Phosphorus ≤ the ULN|Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.|Months 6, 12, and 18|Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1330023|NCT02100670|Secondary|Time of Onset of Pain Relief (TOPR)|TOPR was measured by time when participants reported PRS ≥ 1, i.e. a “little” or “perceptible” pain relief’.|Baseline to 10 days (end of study)|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
1329980|NCT02102204|Secondary|Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal|The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.|Months 6, 12, and 18|Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1329981|NCT02102204|Primary|Number of Participants With Adverse Events|"A serious adverse event is an AE that met at least 1 of the following criteria:~fatal~life threatening~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event.~The relationship of each AE to study treatment was assessed by the investigator.~The following AE grading scale was used:~Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable."|From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.|Participants who received at least 1 dose of etelcalcetide in the current study (20130213).|||participants|||Number
1329982|NCT02101983|Secondary|Mean Cost Savings||3 months|Data was not collected from the participants for this outcome measure.||||||
1329983|NCT02101983|Secondary|Number of Participants Who Successfully Completed the of Quality of Life Form|Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life.|3 months|Subjects must have an unequivocal diagnosis of AML in a documented complete remission, age >/= 55 years with a good performance status and adequate renal and hepatic function. Subjects who decline participation as an outpatient will be approached to participate in the quality of life comparison group.|||Participants|||Count of Participants
1329984|NCT02101983|Primary|Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.|To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.|3 months|Subjects with a documented unequivocal diagnosis of AML in complete remission, age >/= 55 years, with good performance status and adequate renal and hepatic function. Subjects who are eligible for standard of care inpatient HiDAC consolidation will be approached to participate in the Quality of Life comparison group.|||Participants|||Count of Participants
1329985|NCT02101359|Primary|The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.||Day 0|Modified ITT (mITT) Set: All randomised patients for whom there was evidence they used the study medication, and who satisfied the non-inclusion criterion concerning unauthorized previous and concomitant medications. Patients were assigned to the treatment group as treated.|||percentage of responders|||Number
1329986|NCT02101294|Secondary|Measurement of Increase in Wrist Swelling Following FingerRelief Typing|Before and after the typing session, the subject's wrist was measured. The mean change score of all participants is reported here.|Pre and Post||||centimeters||Standard Deviation|Mean
1329987|NCT02101294|Primary|Length of Time Typing FingerRelief Prior to Experiencing Symptoms of CTS|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure, averaged across the two typing sessions that were FingerRelief.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside||||minutes||Standard Deviation|Mean
1329988|NCT02101294|Secondary|Measurement of Wrist Swelling Following Cessation of QWERTY Typing|Before and after typing, the subject's wrists were measured with a tape measure. The change score is reported here.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside||||centimeters||Standard Deviation|Mean
1329989|NCT02101294|Primary|Length of Time Typing QWERTY Prior to Experiencing Symptoms of CTS (Carpal Tunnel Syndrome)|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure. Length of time typing at each QWERTY session was averaged across the two sessions to determine Length of time typing QWERTY.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside||||minutes||Standard Deviation|Mean
1329990|NCT02101190|Primary|Area Under the Curve (AUC0-t)|BIA 9-1067 AUC0-t following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose||||ng.hr/mL||Standard Deviation|Mean
1329991|NCT02101190|Primary|Tmax - Time to Reach Cmax|BIA 9-1067 Tmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose||||hours||Full Range|Median
1329992|NCT02101190|Primary|Cmax - Maximum Plasma Concentration of BIA 9-1067|BIA 9-1067 Cmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1330062|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period||Baseline, Week 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1329996|NCT02101112|Secondary|Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion|Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to May 2014; approximately 6 weeks|All randomized and treated participants|||participants|||Number
1329997|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration [AUC (0-T)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ng*h/mL||90% Confidence Interval|Geometric Mean
1329998|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) [AUC (INF)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ng*h/mL||90% Confidence Interval|Geometric Mean
1329999|NCT02101112|Primary|Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ng/mL||90% Confidence Interval|Geometric Mean
1330000|NCT02101021|Secondary|Randomized Treatment Phase: Overall Response Rate|The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR)|Baseline up to the Last Tumor Assessment Date, up to 3 years|The study was discontinued before initiation of the randomized treatment phase.||||||
1330001|NCT02101021|Secondary|Randomized Treatment Phase: Progression-Free Survival (PFS)|Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause|Baseline up to the Date of Event or Censoring, up to 3 years|The study was discontinued before initiation of the randomized treatment phase.||||||
1330002|NCT02101021|Secondary|Lead-In Phase: Overall Response Rate (ORR)|The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1.|Baseline up to the Last Tumor Assessment Date, up to 3 years|All Enrolled Analysis Set|||Participants|||Count of Participants
1330003|NCT02101021|Secondary|Lead-In Phase: Progression-Free Survival (PFS)|Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study.|Baseline up to the Date of Event or Censoring, up to 3 years|All Enrolled Analysis Set|||Months||Inter-Quartile Range|Median
1330004|NCT02101021|Secondary|Lead-In Phase: Overall Survival (OS)|Overall survival was defined as the time interval from first dose date of MMB to death from any cause|Baseline up to the Date of Death or Censoring, up to 3 years|All Enrolled Analysis Set|||Months||Inter-Quartile Range|Median
1330005|NCT02101021|Primary|Randomized Treatment Phase: Overall Survival (OS)|Overall survival was defined as the time interval from first dose date of MMB to death from any cause|Baseline up to the Date of Death or Censoring, up to 3 years|The study was discontinued before initiation of the randomized treatment phase.||||||
1330006|NCT02101021|Primary|Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events|"Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment.~No statistical analysis was planned or performed for this endpoint."|Up to 28 Days|DLT-Evaluable Analysis Set: participants in the Safety Analysis Set who completed all treatment and safety procedures through Day 28, inclusive, or experienced a DLT prior to Day 29. Participants in the DLT-Evaluable Analysis Set with available data were analyzed.|||percentage of participants|||Number
1330007|NCT02101008|Secondary|Progression Free Survival||Every 56 days - for up to two years||||days||Standard Deviation|Mean
1330008|NCT02101008|Primary|Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Response to treatment will be measured by RECIST evaluation at disease assessment time-points from date of randomization until the date of first documented progression or death from any cause whichever came first (up to five years).||||participants|||Number
1330009|NCT02100839|Secondary|Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change|Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.|Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57||||Max % Change Versus Baseline||Standard Deviation|Mean
1330063|NCT02100514|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1330010|NCT02100839|Primary|Number of Participants Who Incurred Moderate Treatment Emergent Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57||||Number of Participants|||Number
1330011|NCT02100839|Primary|Number of Participants Who Incurred Mild Treatment Emergent Adverse Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57||||Number of Participants|||Number
1330012|NCT02100839|Primary|Number of Participants Who Incurred at Least One Treatment Emergent Event|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57||||participants|||Number
1330013|NCT02100826|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
1330014|NCT02100826|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data|||Hours||Standard Deviation|Median
1330015|NCT02100826|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||hour*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1330016|NCT02100670|Secondary|Patient's Global Assessment in Response to Treatment (PGART)|PGART was measured at the end of study in a scale from 0-4 (Where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent)|up to Day 10|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Participants|||Number
1330017|NCT02100670|Secondary|Time to Complete Recovery|Time to complete recovery measured as the day with complete relief of ankle pain (Participant-rated NRS scores were 0 for pain intensity at rest and pain) and swelling (Participants did not have any apparent swelling nor experience any pain or limitation of movement of the injured ankle as determined by the Principal Investigator or designee during the course of an ankle exam).|up to 240 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
1330018|NCT02100670|Secondary|Ankle Swelling|"Ankle swelling measured by figure of eight method of injured ankle."|Day 1 (baseline), 3, and 7|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Millimeters||Standard Deviation|Mean
1330019|NCT02100670|Secondary|Skin Temperature|Skin temperature was measured by thermal imaging.|At 10, 30, 60 minutes, 4 and 6 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||degree celsius (°C)||Standard Deviation|Mean
1330020|NCT02100670|Secondary|Total Pain Relief (TOTPAR)|TOTPAR was calculated as sum of the products of PRS with time interval from one time point to the other. PRS was measured at each time point on a scale: 0= No pain relief, 1= A little or perceptible pain relief, 2= Meaningful pain relief, 3= A lot of relief, 4= Complete relief. The possible range of TOTPAR for 0-6 hours was from 0 to 24, for 0-12 hours was from 0 to 48, for 0-24 hours was from 0 to 96, for 0-72 hours was from 0 to 288, for 24-72 hours was from 0 to 192 and for 0-168 hours was from 0 to 672.|Baseline to 168 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||PRS Score (0 – 4 scale)||Standard Deviation|Mean
1330021|NCT02100670|Secondary|Time of Onset of Cooling Sensation (TOCS)|Time of onset of cooling sensation measured by time when subjects reported to have a ‘cooling effect as an enhancement of pain relief’. To assess this endpoint, participants were asked at 10, 30 minutes and at 1, 4, 6 hours post first dose “Do you feel a cooling sensation at the injured ankle from the study gel?|up to 6 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
1330064|NCT02100514|Secondary|Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1330024|NCT02100670|Secondary|Sum of Pain Intensity Difference (SPID)|SPID was calculated as the time weighted sum of pain intensity differences (PID) from 0 to 7 Days. PID was calculated as PI at a given time point 't' subtracted by the PI at baseline. PI was measured on NRS scale from 0 (no pain) to 10 (extreme pain). The possible range of SPID for 0-6 hours was from -60 to 60, for 0-12 hours was from -120 to 120, for 0-1 day was from -240 to 240, for 0-3 days was from -720 to 720, for 0-7 days was from -1680 to 1680. A higher value of SPID indicates greater pain relief.|Baseline to Day 7|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||score on a scale||Standard Deviation|Mean
1330025|NCT02100670|Secondary|Pain Relief Score (PRS)|Pain relief was measured at each time point using a 5-point Pain Relief Scale ranging from 0-4 while at rest (Where: 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief). Participants assessed the degree of ankle pain relief using the PRS scores at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after the first day of treatment.|Day 1 to Day 7|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome.|||score on a scale||Standard Deviation|Mean
1330026|NCT02100670|Secondary|PID at Rest|"PID at rest was calculated as PI at a given time point’t’ (at rest) subtracted by the PI at baseline. Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain).~PI was measured at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing."|Baseline to 10 days|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome.|||score on a scale||Standard Deviation|Mean
1330027|NCT02100670|Secondary|Pain Intensity Difference (PID) on Movement|"PID on movement, calculated as PI at a given time 't' (after walking 5 steps on a flat surface) subtracted by the PI at baseline.~Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain). PI was measured at baseline (prior to treatment) and at 10, 30 minutes (min.) and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing."|Baseline to 10 days|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome.|||score on scale||Standard Deviation|Mean
1330028|NCT02100670|Secondary|AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo|AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing.|up to 72 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||NRS Score (0 – 10 scale) * hrs||Standard Deviation|Mean
1330029|NCT02100670|Primary|Area Under the Curve From Day 1 to Day 3 (AUC1-3 Days) of Pain Intensity(PI) on Movement for Diclofenac/Methanol Gel and Placebo Gel|AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing.|up to 72 hours|Intent-to-Treat (ITT) population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||NRS Score (0 – 10 scale) * hrs||Standard Deviation|Mean
1330030|NCT02100644|Secondary|Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation of the Investigational Product and/or Withdrawal From the Study, Drug-related AEs, Deaths and Serious Adverse Events (SAEs) Throughout the Study|An AE is defined as untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgement and all events of possible drug-induced liver injury.|From the start of study treatment until follow-up (up to 50 weeks)|Safety Population: comprised of participants who received at least one dose of the investigational product during the LTG Escalation Phase.|||Participants|||Number
1330031|NCT02100644|Secondary|Percentage of Participants Who Completed or Discontinued From the Study|Following cases were considered for participants to have completed a part of or whole of the study. For whole period completion: participants who completed the last LTG and VPA Maintenance Phase visit (M5) in the LTG and VPA Maintenance Phase and follow-up examination. For LTG Escalation Phase completion: participants who reached 200 mg/d of LTG (or 100-200 mg/d of LTG if there were safety concerns) within 8-18 weeks of the phase. For VPA Reduction Phase completion: participants who completed the last fixed dose of VPA Reduction Phase visit (0 mg/d) (FR4) of the phase. For LTG and VPA Maintenance Phase completion: participants who completed M5 of the phase. Participants who met any of the withdrawal criteria after the start of investigational product were considered to have discontinued the study. Percentage of participants who completed or discontinued/withdrawn from the study is presented.|Up to 50 weeks|Enrolled Population: comprised of all participants who had a Baseline (Week 0) visit.|||Percentage of participants|||Number
1330272|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330032|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) in Participants Aged 15-17 Years|QOLIE-AD-48 is a questionnaire analyzed according to the scoring manual at Baseline, at the end of the LTG/VPA Maintenance Phase and withdrawals for participants aged 15-17 years (n=6). Particpants who has started by QOLIE-AD-48 were using the same questionnaire even after 18 years old. Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-AD-48 has 8 subscale items (epilepsy impact, memory/concentration, physical fuctioning, stigma, social support, school behavior, attitudes towards epilepsy and health perceptions). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-AD-48 is world widely used for the QOL assessment of non-adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).|||Units on a scale||Standard Deviation|Mean
1330033|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy-31-P (QOLIE-31-P) in Participants Aged 18 Years and Older|QOLIE-31-P is a questionnaire analyzed according to the scoring manual at Baseline, at the end of LTG/VPA Maintenance Phase and withdrawals for the participants aged 18 years and older (n=26, excluding 1 participant withdrawn due to protocol violation). Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-31-P has 7 subscale items (energy, mood, daily activities, cognition, medication effect, seizure worry and overall QOL). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-31-P is world widely used for the QOL assessment of adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
1330034|NCT02100644|Secondary|Number of Days in Total That Epileptic Seizures Occurred up to the LTG and VPA Maintenance Phase|The participants with no seizure, had no record in seizure dairy. Only those participants with more than one seizure were assessed for this Outcome Measure.|Baseline and up to 46 weeks|FAS Population|||Days|||Number
1330035|NCT02100644|Primary|Percent Change in the VPA Dose|Percent change in VPA dose is calculated as (pre-dose - post-dose) / pre-dose x 100. Pre-dose is the VPA dose at the Baseline visit and post-dose is the last VPA dose during the LTG and VPA Maintenance Phase.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|FAS Population|||Percentage of reduction||Standard Deviation|Mean
1330036|NCT02100644|Primary|Percentage of Participants Who Achieved Reduction in Daily VPA Dose|The VPA dose reduction from Baseline is defined as post VPA dose minus the Baseline VPA dose < 0. Baseline VPA dose is the dose at the Baseline visit (Week 0) and the post VPA dose is the last VPA dose during the LTG and VPA Maintenance Phase. Percentage of participants with dose reduction during the LTG and VPA Maintenance Phase is presented.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|Full analysis set (FAS): comprised of all participants in the Safety Population who provided at least one efficacy data after the first dose of the investigational product during the LTG Escalation Phase.|||Percentage of participants||95% Confidence Interval|Number
1330037|NCT02100579|Secondary|Length of Hospitalization|The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.|0 to 192 hours||||hours||95% Confidence Interval|Mean
1330038|NCT02100579|Secondary|Visual Analog Scale Pain Score|Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.|Pain burden at 36hr||||scores*hours||Inter-Quartile Range|Median
1330039|NCT02100579|Primary|Opioid Consumption (mg morEq)|Opioid consumption (morphine equivalents)|36 hours||||Morphine Equivalents||Inter-Quartile Range|Median
1330040|NCT02100514|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 log2 unit was considered to be ADA positive and nAb titer >=1.58 log2 unit was considered to be nAb positive.|Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110|"All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, n signifies number of participants who were evaluable at specified time points."|||percentage of participants|||Number
1330041|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period||Baseline, Week 58 (follow up), 71, 84, 97, 110|All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period).|||percent change||Standard Deviation|Mean
1330042|NCT02100514|Secondary|Number of Participants Who Changed Concomitant Medication During Extension Period|In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.|Week 58 follow-up to Week 110|All participants who consented for extension period.|||Participants|||Count of Participants
1330043|NCT02100514|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) unit was considered to be nAb positive.|Baseline up to Week 58|"Analysis set included all participants who received at least 1 dose of PF-04950615 150 mg. This outcome measure was planned not to be analysed for placebo reporting arm. Here N signifies number of subjects who were evaluable for this outcome measure."|||Percentage of participants|||Number
1330065|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1330044|NCT02100514|Secondary|Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to end of study (up to 110 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
1330045|NCT02100514|Secondary|Plasma Concentration Versus Time Summary of PF-04950615||Week 12, 24, 52|"Analysis set included participants who received at least 1 dose of PF-04950615. This outcome measure was planned not to be analysed for placebo reporting arm. Here, n signifies those participants who were evaluable at specified time points."|||microgram per milliliter||Standard Deviation|Mean
1330046|NCT02100514|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
1330047|NCT02100514|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
1330048|NCT02100514|Secondary|Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants evaluable at specified time points."|||ratio||Standard Deviation|Mean
1330049|NCT02100514|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||ratio||Standard Deviation|Mean
1330050|NCT02100514|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330051|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330052|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330053|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330054|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330055|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330056|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330057|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1330058|NCT02100514|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1330059|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1330060|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1330061|NCT02100514|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1330066|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1330067|NCT02100514|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1330068|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1330069|NCT02100514|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1330070|NCT02100514|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, Number of participants analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1330071|NCT02100475|Secondary|Number of Treatment-emergent Confirmed Hypoglycaemic Episodes|Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL).|Week 0 - 26|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (31 subjects). Confirmed hypoglycaemic episodes were reported by 2 subjects in IDegLira arm and 2 subjects in IDegLira + IAsp arm.|||Number of episodes|||Number
1330072|NCT02100475|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|FAS included all randomised subject (31 subjects). Missing data were imputed using the LOCF method.|||Kilograms||Standard Deviation|Mean
1330073|NCT02100475|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|Full analysis set (FAS) included all randomised subjects (31 subjects). Missing data were imputed using the last observation carried forward (LOCF) method.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1330074|NCT02100410|Secondary|Handling on Removal|Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.|||units on a scale||Standard Deviation|Mean
1330075|NCT02100410|Secondary|Lens Awareness|Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.|||units on a scale||Standard Deviation|Mean
1330076|NCT02100410|Primary|Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear|Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.|||percentage of lenses|||Number
1330077|NCT02100280|Secondary|CRP|Blood samples are collected from the antecubital vein of the arm not used for IV infusion 48 hr after the end of operation for analysis of CRP.|48 hr after end of operation||||pg / ml||Standard Deviation|Mean
1330078|NCT02100280|Secondary|IL-8|Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 8.|1 hr after end of operation||||pg / ml||Standard Deviation|Mean
1330079|NCT02100280|Secondary|IL-1β|Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of IL-1β.|30min before end of operation||||pg / ml||Standard Deviation|Mean
1330080|NCT02100280|Secondary|TNF-α|Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of TNF-α.|30min before end of operation||||pg / ml||Standard Deviation|Mean
1330081|NCT02100280|Primary|IL-6|Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.|1 hr after the end of operation||||pg / ml||Standard Deviation|Mean
1330082|NCT02100228|Secondary|Number of Participants Who Used Image Guidance Approach|An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|Full analysis set included all randomized participants.|||participants|||Number
1330083|NCT02100228|Secondary|Duration of Hospital Stay of Participants|Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Full analysis set included all randomized participants. Here N signifies number of participants who were evaluable for this specified outcome measure."|||hours||Full Range|Median
1330193|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms||Day 5||||percentage of participants|||Number
1330084|NCT02100228|Secondary|Number of Participants With Their Rhythm Status|Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute).|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Safety data set included all treated participants (randomized participants who received at least one dose of study drug). Here N signifies number of participants who were evaluable for this specified outcome measure."|||participants|||Number
1330085|NCT02100228|Secondary|Number of Cardioversion Attempt of Participants|Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|Full analysis set included all randomized participants.|||participants|||Number
1330086|NCT02100228|Secondary|Number of Participants With Different Type of Cardioversion Events|Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Full analysis set included all randomized participants. Here N signifies number of participants who were evaluable for this specified outcome measure."|||participants|||Number
1330087|NCT02100228|Secondary|Time to First Attempt of Cardioversion|Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Full analysis set included all randomized participants. Here, N (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure."|||days||Full Range|Median
1330088|NCT02100228|Primary|Number of Participants With All Cause Death||Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Full analysis set included all randomized participants.|||participants|||Number
1330089|NCT02100228|Primary|Number of Participants With Clinically Relevant Non-Major Bleeding Events|Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life.|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Safety data set included all treated participants (randomized participants who received at least one dose of study drug).|||participants|||Number
1330090|NCT02100228|Primary|Number of Participants With Major Bleeding Event|Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Safety data set included all treated participants (randomized participants who received at least one dose of study drug).|||participants|||Number
1330091|NCT02100228|Primary|Number of Participants With Systemic Embolism Event|Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing.|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Full analysis set included all randomized participants.|||participants|||Number
1330092|NCT02100228|Primary|Number of Participants With Acute Stroke Event|An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Full analysis set included all randomized participants.|||participants|||Number
1330093|NCT02100189|Secondary|Tolerability of FISH Spongy Cytology|Tolerability is defined as the patient's willingness to repeat procedure.|After completion of FISH and EGD|Intent to Treat (ITT)|||percentage of subjects tolerating test|||Number
1330094|NCT02100189|Secondary|Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.|At the time of sponge cytology procedure|Intent to Treat (ITT)|||adverse events|||Number
1330095|NCT02100189|Primary|Specificity of Sponge Cytology Using FISH|All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test’s sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.|At the time of sponge cytology and EGD|Per protocol|||Percentage of non-cases among neg tests||95% Confidence Interval|Number
1330096|NCT02100189|Primary|Sensitivity of Sponge Cytology Using FISH|All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test’s sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.|At the time of sponge cytology and EGD|Analysis was per protocol|||percentage of cases among positive tests||95% Confidence Interval|Number
1330097|NCT02100124|Secondary|Contraceptive Adherence|Percentage of surveys where contraceptive adherence was high|24 months||||percentage of surveys||Standard Deviation|Mean
1330098|NCT02100124|Secondary|Contraceptive Method Satisfaction|percentage of surveys where very satisfied with contraceptive method|24 months||||percentage of surveys||Standard Deviation|Mean
1330099|NCT02100124|Secondary|Effectiveness of Contraceptive Method|Percentage of surveys where most effective contraceptive method used|24 months||||percentage of surveys||Standard Deviation|Mean
1330100|NCT02100124|Primary|Contraceptive Use|Percentage of surveys with any contraceptive use|24 months||||percentage of surveys||Standard Deviation|Mean
1330101|NCT02100007|Secondary|Estimate the Overall Survival (OS)|41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.|Up to 2 years||||months||95% Confidence Interval|Median
1330102|NCT02100007|Secondary|Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan|Overall response rate was defined as the total number of patients with Complete Response plus Partial Response. All efficacy assessments were to include a baseline assessment and follow-up assessments at a minimum of every 8 weeks for the first 6 cycles, then every 12 weeks thereafter, while receiving study drug. Tumor response and progression-free survival were assessed using RECIST 1.1 criteria or GCIG criteria for CA-125 levels.|Response was assessed throughout the trial up to 13 months|Part 1 (N =12), Part 2 (N=29)|||participants|||Number
1330103|NCT02100007|Secondary|Mean Terminal Half-life (t 1/2)|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.|||hours||Standard Deviation|Mean
1330104|NCT02100007|Secondary|Minimum Plasma Concentration (Cmin) of ME-344|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.|||ng/mL||Standard Deviation|Mean
1330105|NCT02100007|Secondary|Time to Maximum Plasma Concentration for ME-344 (Tmax)|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1|||hours||Full Range|Mean
1330106|NCT02100007|Secondary|Maximum Plasma Concentration (Cmax)|Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data from 13 patients who received treatment in Part 1 of the study.|||ng/mL||Standard Deviation|Mean
1330107|NCT02100007|Primary|Number of Serious Adverse Events|The SAE Profile will be determined by the number of SAEs|Through study completion- an average of 2 years|46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.|||SAEs|||Number
1330108|NCT02100007|Primary|Number of Adverse Events|The AE Profile will be determined by the number of AEs regardless of severity|Through study completion- an average of 2 years|46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.|||adverse events|||Number
1330109|NCT02099838|Other Pre-specified|Change of DBil From Baseline at Week 12|Measuring venous level of DBil(direct bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in DBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||mmol/L||Standard Deviation|Mean
1330110|NCT02099838|Other Pre-specified|Change of TBil From Baseline at Week 12|Measuring venous level of TBil(total bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in TBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||mmol/L||Standard Deviation|Mean
1330111|NCT02099838|Other Pre-specified|Change of AST From Baseline at Week 12|Measuring venous level of AST at the start of the trail and at week 12 in all subjects, then analyzing the change in AST from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||U/L||Standard Deviation|Mean
1330112|NCT02099838|Other Pre-specified|Change of ALT From Baseline at Week 12|Measuring venous level of ALT at the start of the trail and at week 12 in all subjects, then analyzing the change in ALT from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||U/L||Standard Error|Mean
1330113|NCT02099838|Secondary|Change of LDL From Baseline at Week 12|Measuring venous level of LDL(Low-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of LDL to analyze the change in LDL from baseline at week 12 and compare that between experiment group and control group, since the LDL wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mmol/L)||Standard Deviation|Mean
1330114|NCT02099838|Secondary|Change of HDL From Baseline at Week 12|Measuring venous level of HDL(High-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then analyzing the change in HDL from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
1330115|NCT02099838|Secondary|Change of TG From Baseline at Week 12|Measuring venous level of TG(Triglyceride) at the start of the trail and at week 12 in all subjects, then analyzing the change in TG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
1330116|NCT02099838|Secondary|Change of TC From Baseline at Week 12|Measuring venous level of TC(Total Cholesterol) at the start of the trail and at week 12 in all subjects, then analyzing the change in TC from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
1330117|NCT02099838|Secondary|Change of 2-hour Postprandial Insulin From Baseline at Week 12|Measuring venous level of 2-hour postprandial insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of 2-hour postprandial insulin to analyze the change in 2-hour postprandial insulin from baseline at week 12 and compare that between experiment group and control group, since the 2-hour postprandial insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mU/L)||Standard Deviation|Mean
1330118|NCT02099838|Secondary|Change of Fasting Insulin From Baseline at Week 12|Measuring venous level of fasting insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of fasting insulin to analyze the change in fasting insulin from baseline at week 12 and compare that between experiment group and control group, since the fasting insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mU/L)||Standard Deviation|Mean
1330119|NCT02099838|Secondary|Change of 2hPPG From Baseline at Week 12|Measuring venous level of 2hPPG(2-hour postprandial glucose) at the start of the trail and at week 12 in all subjects, then analyzing the change in 2hPPG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
1330120|NCT02099838|Secondary|Change of FPG From Baseline at Week 12|Measuring venous level of FPG(fasting plasma glucose) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of FPG to analyze the change in FPG from baseline at week 12 and compare that between experiment group and control group, since the FPG wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mmol/L)||Standard Deviation|Mean
1330121|NCT02099838|Primary|Change of HbA1c From Baseline at Week 12|Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then using the natural logarithm of HbA1c to analyze the change in HbA1c from baseline at week 12 and compare that between experiment group and control group, since the HbA1c wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. Intention to treat analysis and last observational carried forward(LOCF) imputation method.|||ln(percent)||Standard Deviation|Mean
1330122|NCT02099708|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
1330123|NCT02099708|Secondary|Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|"Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.~Participants could be counted in more than 1 treatment category."|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
1330124|NCT02099708|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
1330125|NCT02099708|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
1330126|NCT02099708|Secondary|Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
1330127|NCT02099708|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcer.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||Participants|||Number
1330128|NCT02099708|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
1330129|NCT02099708|Primary|Frequency of Adverse Drug Reactions|Frequency was defined as the number of participants for each adverse event Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set (SAS) - All participants who received at least 1 dose of open-label study drug.|||participants|||Number
1330130|NCT02099682|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
1330131|NCT02099682|Secondary|Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
1330132|NCT02099682|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
1330133|NCT02099682|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
1330134|NCT02099682|Secondary|Presence of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
1330135|NCT02099682|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcers.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
1330136|NCT02099682|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of endoscopic examinations.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
1330137|NCT02099682|Primary|Frequency of Adverse Drug Reactions|Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set - All participants who received at least 1 dose of lansoprazole.|||participants|||Number
1330138|NCT02099461|Primary|Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells|Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.|Baseline and Day 28|Pharmacodynamic analysis set with non-missing data|||log ratio||Standard Deviation|Mean
1330139|NCT02099344|Secondary|Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft|Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.|12 months|||||||
1330140|NCT02099344|Primary|Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft|The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.|12 months|Data not collected due to early study termination||||||
1330141|NCT02099318|Other Pre-specified|Wasted Number of Aneurysm Clips|Number of of aneurysm clips wasted according to OR records.|At time of surgery-Time (minutes/seconds) from first aneurysm clip attempt to final clip placement|Data was lost; no results can be reported||||||
1330142|NCT02099318|Other Pre-specified|Microsurgical Time|"Number of minutes of total microsurgical time:~Defined as the time elapsed from the time the aneurysm was first observed in the OR microscope until the time that the final clip was applied"|At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placement|Data was lost; no results can be reported||||||
1330143|NCT02099318|Other Pre-specified|Temporary Clip Time|"Total Number of minutes of temporary clip occlusion:~Defined as the time the temporary clip is released from the clip applier until the temporary clip is removed. (For several temporary occlusions, a cumulative total of all temporary occlusions and total time of overall temporary occlusion time as observed in the operating microscope's video.)"|At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removal|Data was lost; no results can be reported||||||
1330144|NCT02099318|Secondary|Number of Trial Aneurysm Clips Used But Not Implanted|"Number of Clips evaluated:~Defined as clips that were brought in proximity to the aneurysm for evaluation (i.e., were visible in the microscopic field) but were not applied, as observed in the operating microscope's video."|At time of surgery-Time (minutes/seconds) from first clip to contact aneurysm to final clip placement|Data was lost; no results can be reported||||||
1330145|NCT02099318|Primary|Aneurysm Clip Time|"Number of Clipping attempts:~Applying a clip (i.e., closing a clip on the aneurysm)~Removing a clip (i.e., a clip was applied on the aneurysm and then removed)~Adjusting a clip (i.e., the clip was applied on the aneurysm and then opened, adjusted, and closed again)."|At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)|Data was lost; no results can be reported||||||
1330146|NCT02099266|Secondary|Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.|Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.|28 days||||Participants|||Count of Participants
1330147|NCT02099266|Secondary|Determine the Effects of HBO Therapy on Neutrophil Count Recovery.|Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.|Daily measurement of neutrophil counts up to 90 days post transplant.||||Days||Full Range|Median
1330148|NCT02099266|Primary|Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation|Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.|Toxicity assessment with 24hrs of treatment|One patient treatment was shortened by approximately 10 minutes because of nausea attributed to concomitant medications.|||Participants|||Count of Participants
1330149|NCT02099110|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26: Excluding Rescue Approach|This change from baseline reflects the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the systolic blood pressure change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||mm Hg||95% Confidence Interval|Least Squares Mean
1330150|NCT02099110|Secondary|Change From Baseline in Static Beta-Cell Sensitivity to Glucose Index at Week 26; Excluding Rescue Approach|Static beta-cell sensitivity to glucose index (SBCSGI) estimates the ratio of insulin secretion (expressed in pmol/min) related to above-basal glucose concentration (expressed in mmol/L * L) following a meal. Blood samples were collected before and after a standard meal and glucose, insulin, and C-peptide levels were analyzed. The C-peptides minimal model was used to estimate the insulin secretion rate (ISR). Analysis included both non-model-based [including insulinogenic index with C-peptide, glucose area under the curve (AUC)/insulin AUC] and model-based [beta cell function and insulin secretion rate at 9 mM glucose] testing. Analysis was performed with non-linear least squares using the Software Architecture Analysis Method (SAAM) II software. SBCSGI was expressed in units of 10^-9 min^-1. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|30 min. before and 0, 15, 30, 60, 90, 120, and 180 minutes following the start of the standard meal at Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the beta-cell responsivity static component change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||SBCSGI (10^-9min^-1)||95% Confidence Interval|Least Squares Mean
1330151|NCT02099110|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <7% (<53 mmol/Mol) (Raw Proportions): Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||Percentage of participants|||Number
1330152|NCT02099110|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Excluding Rescue Approach|Blood glucose was measured on a fasting basis after at least a 10-hour fast. This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the FPG change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1330194|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms||Day 5||||percentage of participants|||Number
1330153|NCT02099110|Secondary|Change From Baseline in Body Weight at Week 26: Excluding Rescue Approach|This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the body weight change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||Kilograms||95% Confidence Interval|Least Squares Mean
1330154|NCT02099110|Primary|Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.|Up to 52 weeks|The analysis population consists of all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
1330155|NCT02099110|Primary|Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.|Up to 54 weeks|The analysis population consists of all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
1330156|NCT02099110|Primary|Change From Baseline in A1C at Week 26: Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||Percentage||95% Confidence Interval|Least Squares Mean
1330157|NCT02099084|Other Pre-specified|Urine Volume at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. Urine was collected twice: from the start of the ingestion of the meal to 2 hours, and 2-8 hours. The total volume of urine collected was the sum of these two collections.|Start of the ingestion of the radiolabeled meal until 8 hours after the meal||||mL||Standard Deviation|Mean
1330158|NCT02099084|Other Pre-specified|Stool Weight at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. After 8 hours a stool collection was taken.|approximately 8 hours after ingestion of radiolabeled meal||||g||Standard Deviation|Mean
1330159|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal||||ratio||Standard Deviation|Mean
1330160|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal||||mg||Standard Deviation|Mean
1330161|NCT02099084|Primary|Overall Gut Transit|Given the variable extent of the residual length of the small intestine and colon, the proportion emptied from the body at 6 hours was assessed as an overall estimate of the whole gut transit. The 6-hour values for intra-abdominal counts were then compared with the 100% reference values of counts (at time zero, which is immediately after ingestion of the radiolabeled meal) to determine the percentage of isotope retained in the abdomen. 100% minus the percentage of retained isotope reflected the amount emptied from the GI tract.|baseline, approximately 6 hours after ingestion of radiolabeled meal||||Percentage of isotope emptied||Standard Deviation|Mean
1330162|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal||||mg||Standard Error|Mean
1330163|NCT02099084|Primary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested||||minutes||Standard Deviation|Mean
1330164|NCT02099006|Secondary|Reduction in Tampon Test Pain|"Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of 0 was defined as no pain, and a score of 10 was defined as worst imaginable pain."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.|||units on a scale||Standard Deviation|Mean
1330195|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms||Up to Day 8 (total collection)||||percentage of participants|||Number
1330165|NCT02099006|Primary|Reduction in Daily Genital Pain.|"Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of 0 was defined as no pain and a score of 10 was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.|||units on a scale||Standard Deviation|Mean
1330166|NCT02098746|Primary|Frequency of Serious Adverse Drug Reactions|Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).|||participants|||Number
1330167|NCT02098746|Secondary|Change From Baseline in Fasting Insulin Level|Tabulation of fasting insulin level and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.|||μU/dL||Standard Deviation|Mean
1330168|NCT02098746|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulation of fasting blood glucose level and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.|||mg/dL||Standard Deviation|Mean
1330169|NCT02098746|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of HbA1c values and the changes from Baseline at each test time point (test value at each test time point after Baseline – test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.|||percent||Standard Deviation|Mean
1330170|NCT02098746|Primary|Frequency of Adverse Drug Reactions|Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).|||participants|||Number
1330171|NCT02098733|Secondary|Fasting Insulin Level|Tabulated fasting insulin level at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||μU/dL||Standard Deviation|Mean
1330172|NCT02098733|Secondary|Change From Baseline in Fasting Insulin Level|Tabulated the changes from baseline at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||μU/dL||Standard Deviation|Mean
1330173|NCT02098733|Secondary|Fasting Blood Glucose Level|Tabulated fasting blood glucose level from baseline at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||mg/dL||Standard Deviation|Mean
1330174|NCT02098733|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||mg/dL||Standard Deviation|Mean
1330175|NCT02098733|Secondary|Glycosylated Hemoglobin (HbA1c)|Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1330176|NCT02098733|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1330177|NCT02098733|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|For 12 months|All enrolled participants with available data.|||participants|||Number
1330196|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms||Up to Day 8 (total collection)||||percentage of participants|||Number
1330213|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
1330178|NCT02098395|Secondary|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes|Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.|Weeks 0-26|Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.|||episodes|||Number
1330179|NCT02098395|Secondary|Change From Baseline in Body Weight|Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.|||kg||Standard Deviation|Mean
1330180|NCT02098395|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1330181|NCT02098369|Secondary|PROMIS - Ability to Participate in Social Roles and Activities|Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
1330182|NCT02098369|Secondary|PROMIS - Satisfaction With Social Roles and Activities|Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
1330183|NCT02098369|Secondary|PROMIS - Emotional Distress - Depression|Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
1330184|NCT02098369|Secondary|PROMIS - Sleep Disturbance|Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
1330185|NCT02098369|Secondary|PROMIS - Emotional Distress - Anxiety|Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
1330186|NCT02098369|Secondary|PROMIS - Fatigue|Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
1330187|NCT02098369|Secondary|PROMIS - Physical Function|Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
1330188|NCT02098369|Primary|Adherence to Supplemental O2 Prescription|Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day|60 days|All participants with evaluable data for oxygen use across all equipment.|||Participants|||Count of Participants
1330189|NCT02098304|Secondary|User Experience|Completion of User Questionnaires after imaging with the Calcivis System|0 day|User Questionnaires comprised nine questions and users were asked to tick the most appropriate response i.e. extremely easy, easy etc. No numerical values were assigned to the responses.|||User questionnaires|||Number
1330190|NCT02098304|Secondary|Patient Experience|Completion of Patient Questionnaires after imaging with the Calcivis System|Day 0|Patient Questionnaires comprised five questions and the patient was asked to tick the most appropriate response i.e very good, good etc. No numerical values were assigned to the responses|||Patient Questionnaires|Participants||Number
1330191|NCT02098304|Primary|Measure Safety of the Calcivis Caries Imaging System|Collection of all adverse events recorded and reported throughout the duration of the study|Day 0 and Day 7|Adverse events|||adverse events|||Number
1330192|NCT02098304|Primary|Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System|% agreement calculated as no. of teeth where ICDAS assessment & Calcivis System assessment is in agreement/total number of teeth assessed multiplied by 100. Agreement defined as a sound tooth without luminescence & an unsound tooth with luminescence.|Day 0|All 42 patients recruited are included in the Safety Population, which included any subjects on whom the Calcivis System was used. 31 patients are included in the Agreement Population which included all subjects with at least one tooth with an eligible image. From the 31 patients, 65 teeth were analysed; in some patients multiple teeth were imaged.|||percentage agreement|Participants|95% Confidence Interval|Number
1330197|NCT02098109|Secondary|Comparison of the Readmission Rate Between the Two Arms|Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse|Up to Day 100|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.|||Participants|||Count of Participants
1330198|NCT02098109|Secondary|Comparison of the Time to Platelet Engraftment Between the Two Arms|Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.|Up to Day 100|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1330199|NCT02098109|Secondary|Comparison of the Time to Neutrophil Engraftment Between the Two Arms|Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.|Up to Day 30 post-infusion|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1330200|NCT02098109|Secondary|Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms|-Adverse events will be assessed using CTCAE version 4.0|Up to 20 days after last apheresis (Day 25-Day 28)||||participants|||Number
1330201|NCT02098109|Primary|Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms||Day 5||||cells/kg||Standard Deviation|Mean
1330202|NCT02097992|Primary|Airway Blood Flow Reactivity (Delta Qaw)|percentage of change on airway blood flow induced by albuterol.|Immediate or 4 weeks||||% of change||Standard Error|Mean
1330203|NCT02097849|Secondary|Number of Participants With Abnormalities in Vital Signs|Temperature increase: > 38 celcius (C) or ≥ 1 C increase from baseline. Pulse increase: > 120 beats per minute (bpm) or > 20 bpm increase from baseline. Pulse decrease: < 50 bpm or > 20 bpm decrease from baseline. Systolic blood pressure (SBP) increase: > 180 millimeters of mercury (mmHg) or > 40 mmHg from baseline. SBP decrease: < 90 mmHg or > 30 mmHg decrease from baseline. Diastolic blood pressure (DBP) increase: > 105 mmHg or > 30 mmHg increase from baseline. DBP decrease: < 50 mmHg or > 20 mmHg decrease from baseline.|Screening to Week 4|Participants who had a baseline assessment and at least one postbaseline assessment.|||participants|||Number
1330204|NCT02097849|Secondary|Number of Participants With Shifts From Baseline in Blood Chemistry|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.|Screening to Week 4|n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.|||participants|||Number
1330205|NCT02097849|Secondary|Number of Participants With Shifts From Baseline in Hematology|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.|Screening to Week 4|n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.|||participants|||Number
1330206|NCT02097849|Secondary|Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.|Day 1 to Week 4|Participants who received at least one vaccination.|||participants|||Number
1330207|NCT02097849|Secondary|Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.|||ratio||Inter-Quartile Range|Median
1330208|NCT02097849|Secondary|Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||ratio||Inter-Quartile Range|Median
1330209|NCT02097849|Secondary|Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||ratio||Inter-Quartile Range|Median
1330210|NCT02097849|Secondary|Ratio of Serum Tetanus Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination||||ratio||Inter-Quartile Range|Median
1330211|NCT02097849|Secondary|Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.|||percentage of participants||95% Confidence Interval|Number
1330212|NCT02097849|Secondary|Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.|||percentage of participants||95% Confidence Interval|Number
1330246|NCT02097537|Secondary|The Summary Statistics of PC20|PC20 : the concentration of methacholine causing 20% fall in FEV1.|Visit 1 (Day 1)||||mg/mL||Standard Deviation|Mean
1330214|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
1330215|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
1330216|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
1330217|NCT02097849|Secondary|Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
1330218|NCT02097849|Primary|Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
1330219|NCT02097823|Other Pre-specified|Number of Participants With Adverse Events.|Olanzapine will be considered tolerable if less than 10% of patients experience a grade III or IV adverse event attributable to olanzapine.|Ongoing, throughout the study. Will be fully evaluated in approximately 1 year, at the conclusion of data collection. Each patient will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks.||||participants|||Number
1330220|NCT02097823|Secondary|Good Control of Nausea|"Good control of nausea will be ratings <25 on visual analog scale by parents and <2 on baxter retching faces scale by patients. Will look at the proportions of patients with good control of nausea.~The visual analog scale ranged from 0-100, with 0 being no nausea and 100 being very very severe nausea. The Baxter retching faces scale ranged from 0-10 using only even numbers (0,2,4,6,8,10) and each number has a corresponding face depicting someone experiencing varying levels of nausea, with 0 being no nausea and 10 being a picture of face vomiting."|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.|could only analyze cycles where subjects had returned completed forms|||percentage of participant w/good control|||Number
1330221|NCT02097823|Secondary|Complete Response in Delayed Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the delayed phase (25-120 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of participants with CR|||Number
1330222|NCT02097823|Secondary|Complete Response in Acute Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the acute phase (0-24 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of participants with CR|||Number
1330223|NCT02097823|Secondary|Complete Response in Overall Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the overall phase (0-120 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of participants with CR|||Number
1330224|NCT02097823|Primary|Feasibility of Recruitment and Data Collection.|Primary objective of this study is to determine the feasibility of recruitment and data collection for conducting a larger trial. Recruitment and data collection will be feasible if at least 20 subjects can be recruited in 1 year and there is a 90% form completion rate.|Approximately 1 year after study opens, at the conclusion of data collection. Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of completed forms|Administered forms||Number
1330225|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1330226|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score joint space narrowing of 0-4 (9 gradations) is assigned to 13 joints in each hand and 6 joints in each foot. The maximum joint space narrowing score is 38 x 4.0 = 152 which is normalized to a score of 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1330247|NCT02097537|Secondary|The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation||Visit 1 (Day 1)||||percentage of the subjects|||Number
1330273|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330227|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1330228|NCT02097745|Secondary|Change From Baseline in the Total Genant-modified Sharp Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1330229|NCT02097745|Secondary|Percentage of Participants With no Radiographic Progression From Baseline to Year 5|Radiographic progression was defined as a change of ≤ 0 in the total Genant-modified Sharp score. The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1330230|NCT02097745|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT-F is a 13-item participant self-reporting questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
1330231|NCT02097745|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
1330232|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
1330233|NCT02097745|Secondary|Change From Baseline in the American College of Rheumatology n (ACRn) Response|The ACRn response was defined as each participant’s least favorable percentage change from Baseline in 3 measures, tender joint count, swollen joint count (28 assessed joints), and improvement score achieved in at least 3 of the 5 remaining ACR parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity, right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain, right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). A higher change percentage indicates greater improvement from Baseline. The ACRn response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage change||Standard Deviation|Mean
1330248|NCT02097537|Primary|The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL|"The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer.~For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more.~The concentration of methacholine causing 20% fall in FEV1 is PC20."|Visit 1 (Day 1)||||percentage of the subjects|||Number
1330234|NCT02097745|Secondary|Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage of participants|||Number
1330235|NCT02097745|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity was defined as a DAS28 score ≤ 3.2. DAS28 remission was defined as a DAS28 score < 2.6. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage of participants|||Number
1330236|NCT02097745|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28)|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score represents higher disease activity. A negative change score indicates improvement. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
1330237|NCT02097745|Primary|Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage of participants|||Number
1330238|NCT02097732|Other Pre-specified|Immune Correlates|Exploratory endpoints: Interval changes in immune markers in the blood|6 months|||||||
1330239|NCT02097732|Other Pre-specified|Imaging Correlates on Dynamic-contrast Enhanced MRI of the Brain|Exploratory endpoints: Interval changes in dynamic MRI parameters such as perfusion, blood volume, vascular permeability (Ktrans), and diffusion tensor imaging; the change in 3D tumor volume.|6 months|||||||
1330240|NCT02097732|Secondary|Time to Progression|Time to progression in the brain due to treated metastases or new brain metastases. Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) was used to assess response. Progression was defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 wk from the date first documented.|Up to 40 months|||||||
1330241|NCT02097732|Secondary|Intracranial Response Rate|Response of treated (irradiated) brain metastases to combination therapy with ipilimumab and stereotactic radiosurgery using immune-related response criteria.|Up to 12 months||||Participants|||Count of Participants
1330242|NCT02097732|Secondary|Regional (Intracranial) Control Rate|The proportion of patients in each arm who are free from progression in the index (radiated) lesions and free from new brain metastases at 6 months.|6 months||||Participants|||Count of Participants
1330243|NCT02097732|Secondary|Overall Survival Rate||Up to 40 months|||||||
1330244|NCT02097732|Primary|Local Control Rate|"The number of patients in each arm who are free from progression in the index (radiated) lesions in the brain at 6 months.~Immune related response criteria was used to assess response to treatment. Immune-related Progressive Disease (irPD) in this trial is defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented."|6 months||||Participants|||Count of Participants
1330245|NCT02097719|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication with data at the noted time point|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1330249|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||IU/mL||90% Confidence Interval|Geometric Mean
1330250|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||U/mL||90% Confidence Interval|Geometric Mean
1330251|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||IU/mL||90% Confidence Interval|Geometric Mean
1330252|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||ug/mL||90% Confidence Interval|Geometric Mean
1330253|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||mIU/mL||90% Confidence Interval|Geometric Mean
1330254|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||IU/mL||90% Confidence Interval|Geometric Mean
1330255|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects|GMCs of these IgG proteins were measured to assess potential interference of PATH-wSP with 10-valent pneumococcal conjugate vaccine (Synflorix). GMCs of Cohort 1 were measured at a different time point than those in Cohort 2, so results are presented separately.|12 weeks (Cohort 1) and 4 weeks (Cohort 2) post-vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||ug/mL||90% Confidence Interval|Geometric Mean
1330256|NCT02097472|Secondary|Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin|Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||Participants|||Count of Participants
1330257|NCT02097472|Secondary|Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin|Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||Participants|||Count of Participants
1330258|NCT02097472|Secondary|Fold Change in IgG Response to PiaA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330259|NCT02097472|Secondary|Fold Change in IgG Response to PiuA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330260|NCT02097472|Secondary|Fold Change in IgG Response to SPWCA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330261|NCT02097472|Secondary|Fold Change in IgG Response to PcpA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330262|NCT02097472|Secondary|Fold Change in IgG Response to StkP Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330263|NCT02097472|Secondary|Fold Change in IgG Response to BCH0785 Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330264|NCT02097472|Secondary|Fold Change in IgG Response to PhtD Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330265|NCT02097472|Secondary|Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330266|NCT02097472|Secondary|Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330267|NCT02097472|Secondary|Fold Change in IgG Response to PspA-Fam1 (ELISA)|Measured using ELISA|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330268|NCT02097472|Secondary|Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)|Measured using ELISA|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
1330274|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330275|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330276|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD|Measured using ELISA|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330277|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330278|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA|Measured using ELISA|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330279|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA|Measured using ELISA|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
1330280|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein|MSD Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330281|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein|MSD Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330282|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein|MSD Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330283|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330284|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330285|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330286|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330287|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay||0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
1330288|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein|Measured using meso scale discovery (MSD).|0 days, 28 days (Dose 1) and 56 days (Dose 2)|Insufficient sample|||titer||90% Confidence Interval|Geometric Mean
1330289|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay|Measured with enzyme-linked immunosorbent assay (ELISA).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||titer||90% Confidence Interval|Geometric Mean
1330290|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay|Measured with enzyme-linked immunosorbent assay (ELISA).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||titer||90% Confidence Interval|Geometric Mean
1330291|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330292|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330293|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330294|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330295|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330296|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 2: includes diffuse macular/maculopapular/morbilliform rash"|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330297|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330298|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330299|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 1: does not interfere with activity Grade 2: interferes with activity"|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330300|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330301|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 2 includes use of non-narcotic pain reliever for more than 24 hours."|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330302|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Headache Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours."|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330303|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330304|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
1330305|NCT02097303|Other Pre-specified|Overall Response Rate|Determination of measurable disease progression or response was based on modified RECIST criteria. Reported is the number of participants with either a partial or complete response, and who had radiological extraskeletal progression.|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||Participants|||Count of Participants
1330306|NCT02097303|Primary|Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)|"Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI)~Pain Severity: Pain severity is the composite of scores of worst pain, least pain, average pain, and pain now. CMI criteria: Decrease >30% at two consecutive visits in Pain Severity Score in 24 hours without an increase in analgesic use.~Pain interference: Pain interference is the composite scores on general activity, mood, walking ability, normal work, relationships with others, sleep and enjoyment of life. CMI criteria: Decrease by 1.25 points or more compared with baseline at two consecutive visits.~Transient Pain Flare: Based on the work of Atkinson et al, a transient pain flare was assessed by pain at its worst in 24 hours. CMI criteria: > 2 points on the BPI-SF Worst Pain scale and subsequent reduction after initiation of Ra-223 and during the first 3 cycles."|Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.||||Participants|||Count of Participants
1330307|NCT02097303|Other Pre-specified|Bone Imaging Response (Number of Participants With Progression and Stable Disease)|Bone imaging response was assessed at baseline and at EOT visit. Progression was defined as two or more additional lesions in comparison to the baseline.|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||Participants|||Count of Participants
1330308|NCT02097303|Secondary|Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment|[Not Specified]|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||Lesions||Standard Deviation|Mean
1330309|NCT02097303|Secondary|Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment|[Not specified]|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||ng/dL||Standard Deviation|Mean
1330914|NCT02090088|Secondary|Number of Participants With Spontaneous and Elective Abortions or Stillbirths|Number of each of spontaneous abortions, elective abortions, and stillbirths among mothers who received Nplate® therapy at any time during the pregnancy.|9 months (during pregnancy)|All enrolled participants|||participants|||Number
1330310|NCT02097303|Secondary|Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported.|All adverse events relevant to advanced mCRPC subjects as well as adverse events of interest for both Abiraterone Acetate plus Prednisone and Radium Ra 223 dichloride will be reported.|Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.||||Adverse Events|||Number
1330311|NCT02097303|Primary|Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria|"Following Quality of Life questionnaires were given at each visit:~FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the PCS (Range 1-156, higher scores better).~The FACT-General (FACT-G) is a 28 item QOL measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), Emotional (0-24) Well-being, and Satisfaction with Treatment was not assessed for this study (The total range was between 1-108, higher scores better)~FACT-TOI is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better)~PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better)."|Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.|Improvement at the EOT visit was defined as increase from baseline of >= 10 points for FACT-P Total Scale. >9 points for FACT-G Total and FACT-TOI scales, and >=3 points for the remaining scales.|||Participants|||Count of Participants
1330312|NCT02097290|Secondary|LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome|"This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:~A device-determined threshold~A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests~A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above."|3-month follow up visit|A total of 182 unique subjects in whom a paired LVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an LVAT threshold test outcome and core lab determined threshold test outcome.|||percentage of appropriate outcome||95% Confidence Interval|Number
1330313|NCT02097290|Secondary|RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome|"This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:~A device-determined threshold~A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests~A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above."|3-month follow up visit|A total of 157 unique subjects in whom a paired RVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an RVAT threshold test outcome and core lab determined threshold test outcome.|||percentage of appropriate outcome||95% Confidence Interval|Number
1330314|NCT02097290|Primary|The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold – ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis."|1-month and 3-month follow up visits|A total of 300 paired datasets (from 175 unique subjects in whom LVAT threshold was available), each dataset consisting of a ambulatory LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||Percentage of accurate threshold|LVAT ambulatory threshold paired dataset|95% Confidence Interval|Number
1330315|NCT02097290|Primary|The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold – ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold – ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis."|1-month and 3-month follow up visits|A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||Percentage of RVAT ambulatory thresholds|RVAT ambulatory threshold paired dataset|95% Confidence Interval|Number
1330316|NCT02097290|Primary|The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold – core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold – core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis."|1-month and 3-month follow up visits|A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||Percentage of commanded LVAT thresholds|Commanded LVAT thresholds-paired dataset|95% Confidence Interval|Number
1330317|NCT02097290|Primary|The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold – core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold – core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis."|1-month and 3-month follow-up visits|A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||percentage of commanded RVAT thresholds|Commanded RVAT thresholds paired dataset|95% Confidence Interval|Number
1330318|NCT02097290|Primary|Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate|Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.|3 months|Implant + Attempt Subjects|||Percentage of participants||95% Confidence Interval|Number
1330319|NCT02097238|Secondary|PK Parameters of Eribulin Mesylate|Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the area under the curve, clearance and half-life will be calculated. The analytic unit for monitoring for excessive toxicity will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.|Per Cycle Incidence of dose limiting toxicity.||2017-12-31|12/2017||||
1330320|NCT02097238|Secondary|Number of Cycles Where a Dose Limiting Toxicity Was Identified|Each cycle where the patient receives eribulin and does not receive nonprotocol anticancer therapy will be considered in the analysis. A dose limiting toxicity is defined to be: Day 8 eribulin dose is held due to Grade 3 or Grade 4 nonhematological toxicity attributable to the investigational drug and does not resolve to meet eligibility or baseline criteria by Day 11. Any ≥ Grade 3 nonhematological toxicity attributable to the investigational drug with the specific exclusion of: Grade 3 nausea and vomiting < 3 days duration Grade 3 liver enzyme elevation, including ALT/AST/GGT, that returns to Grade ≤ 1 or baseline prior to the time for the next treatment cycle.|39 cycles were considered for this analysis|19 patients were treated on protocol therapy. Thirty-nine cycles were reported for the analysis of dose limiting toxicity.|||Cycle|Cycles||Number
1330321|NCT02097238|Primary|RECIST Response|The number of patients who experience a complete or partial response according the the RECIST criteria as defined in Eisenhauer et al. Eur J Cancer 45:228-47, 2009.|First 5 cycles of protocol therapy||||participants|||Number
1330322|NCT02097238|Primary|Disease Control Success|The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.|Four Months following enrollment on the study||||participants|||Number
1330323|NCT02097134|Secondary|Vision Acuity, Assessed According to the Amblyopia Treatment Study Visual Acuity Testing Protocol|Estimated by the average visual acuity amongst patients evaluated with a 95% confidence interval.|1 year after therapy|||||||
1330324|NCT02097134|Secondary|Rate of Metastases of Retinoblastoma||Up to 2 years|||||||
1330325|NCT02097134|Secondary|Probability of Ocular Salvage||2 years|||||||
1330326|NCT02097134|Secondary|Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy|The occurrence of each grade 3 or higher CTCAE adverse experience will be recorded in each patient-cycle. The percentage of patients with each toxicity will be tabulated per cycle according to the methodology in place for the study progress report at the time.|Up to 5 years|||||||
1330327|NCT02097134|Primary|Number of Patients Experiencing Feasibility Failure|Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likely related treatment.|Up to 4 months|All Patients who are eligible and evaluable for the feasibility outcome are included in this outcome|||participants|||Number
1330328|NCT02097108|Secondary|High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks||baseline to week 24||||mg/dl||Standard Deviation|Mean
1330329|NCT02097108|Secondary|Triglycerides Baseline and After 24 Weeks||baseline to week 24||||mg/dl||Standard Deviation|Mean
1330330|NCT02097108|Secondary|Total Cholesterol Baseline and After 24 Weeks||baseline to week 24||||mg/dl||Standard Deviation|Mean
1330331|NCT02097108|Primary|Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction|A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.|baseline to week 12|all patients|||percentage of participants||95% Confidence Interval|Number
1330332|NCT02097056|Secondary|Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores|The NPI-Q assessed twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient’s caregiver who was asked if the behavior described is present in the patient. If “Yes”, the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.|Baseline, Week 12, and Week 24 (Follow up visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.|||Scores on a scale||Standard Deviation|Mean
1330333|NCT02097056|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. The mean change was analyzed by Wilcoxon’s signed rank test.|Baseline, Week 12, and Week 24 (Final visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.|||Scores on a scale||Standard Deviation|Mean
1330334|NCT02097056|Primary|Overall Summary of Adverse Events (AEs)|Safety of study drug was assessed by clinical laboratory assessments, vital signs, weight, 12-lead electrocardiogram (ECG), physical and neurological examination. Treatment-Emergent Adverse Events (TEAEs) were defined as any event not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Serious adverse events were defined as AEs that led to or were life-threatening, resulted in or prolonged hospitalization, caused important or long-lasting disability, caused congenital abnormality or malformation, or resulted in death. Adverse drug reactions were defined as any harmful or unintended reaction to study treatment and were considered possibly related or probably related to study drug. Specific AEs and SAEs due to changes in clinical laboratory assessments, vital signs, weight, ECG, and physical and neurological exam are listed in the safety section.|Baseline (Day 1) up to Week 24|Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment.|||Percentage of participants|||Number
1330335|NCT02097030|Secondary|Ocular Health - Biomicroscopy|The investigator’s objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)|3 Days Follow-up|Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study.|||units on a scale||Standard Deviation|Mean
1330336|NCT02097030|Secondary|Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up||||units on a scale||Standard Deviation|Mean
1330337|NCT02097030|Secondary|Lens Fit and Performance - Fit Acceptance|The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up||||units on a scale||Standard Deviation|Mean
1330338|NCT02097030|Secondary|Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).|Baseline and 3 days follow-up||||units on a scale||Standard Deviation|Mean
1330339|NCT02097030|Secondary|Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)|Baseline and 3 day follow-up||||units on a scale||Standard Deviation|Mean
1330340|NCT02097030|Secondary|Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);|Baseline and 3 days follow-up||||units on a scale||Standard Deviation|Mean
1330341|NCT02097030|Secondary|Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).|Baseline and 3 days follow-up||||units on a scale||Standard Deviation|Mean
1330915|NCT02090088|Secondary|Number of Children Born With a Specific Pattern of Minor Birth Defects|Only those infants who have received medical evaluation and who have three or more minor defects will be considered “affected” for purposes of the evaluation of a pattern of minor defects.|At birth|Children born with 3 or more minor birth defects||||||
1330342|NCT02097030|Secondary|Overall Satisfaction|Participant’s subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
1330343|NCT02097030|Secondary|Overall Satisfaction, Dryness|Participant’s subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
1330344|NCT02097030|Secondary|Overall Satisfaction, Handling|Participant’s subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
1330345|NCT02097030|Secondary|Overall Satisfaction, Comfort|Participant’s subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
1330346|NCT02097030|Secondary|Overall Satisfaction, Vision|Participant’s subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
1330347|NCT02097030|Secondary|Subjective Response for Dryness|Participant’s subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
1330348|NCT02097030|Secondary|Subjective Response for Handling (Insertion and Removal)|Participant’s subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|3 days follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
1330349|NCT02097030|Secondary|Subjective Response for Insertion|Participant’s subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|Baseline|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
1330350|NCT02097030|Secondary|Subjective Response for Vision|Participant’s subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
1330351|NCT02097030|Secondary|Subjective Response for Comfort|Participant’s subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
1330352|NCT02097030|Primary|Overall Lens Preference - Hydrogel vs. Filcon II 3|Participant’s subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|30 subjects|||participants|||Number
1330353|NCT02097030|Primary|Overall Lens Preference - All Study Lenses|Participant’s subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
1330354|NCT02096952|Primary|Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score|"The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.~The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score."|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
1330355|NCT02096900|Post-Hoc|Modified Yale Preoperative Anxiety Scale (mYPAS) Score at Separation (mYPAS2) Based on Baseline (mYPAS1) Score.|"Midazolam group participants will be separated into two groups; non-anxious (mYPAS1 ≤ 30) at baseline and anxious (mYPAS1 > 30) at baseline. The mYAPS2 scores of these two groups will be compared to the mYPAS2 scores of the Zolpidem group participants.~The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children that takes less than a minute to preform. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. A cut off 30 on the m-YPAS scale was found to balance the high specificity and sensitivity while maintaining high positive predictive value. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious."|Up to 24 hours including pre-operative, peri-operative and post-operative periods.||||units on a scale||Inter-Quartile Range|Median
1330356|NCT02096900|Secondary|Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)|"Parental/caregiver anxiety, was assessed using the validated State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire.~The STAI is compromised of separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel “right now, at this moment”. The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how respondents generally feel. The score ranges from 20 (most relaxed) to 80 (highest stress).~The baseline STAI inventory was completed by e parent/caregiver after obtaining the informed consent in the preoperative holding area and before the subject was separated from the caregiver. Baseline STAI inventory consisted of form STAIY-1 (State Anxiety) and form STAIY-2 (Trait Anxiety) anxiety.~After caregiver/patient separation,form STAIY-1(State Anxiety) was completed again by the caregiver."|Preoperative holding area from the time of informed consent until caregiver/patient separation.|only total of 51 subjects were analyzed. Caregivers of 29 subjects were given incorrect form to fill at time of separation rendering data not applicable for analysis for the 29 subjects.|||units on a scale||Standard Deviation|Mean
1330357|NCT02096900|Secondary|Presence of Emergence Delirium During Recovery|Presence or absence of emergence delirium during recovery, will be assessed using the pediatric anesthesia emergence delirium (PAED) scale recorded at 5-minute intervals for 20 minutes following the child's spontaneous eye opening. PAED score of ≥12 at any time indicates presence of emergence delirium.|Up to 30 minutes after child's first eye opening in the post-operative period.||||Participants|||Count of Participants
1330358|NCT02096900|Secondary|Mask Acceptance Score|"Mask acceptance by the patient, will be measured on a 4-point scale adapted from a similar trial.~Score of 1 and 2 indicates satisfactory mask acceptance. Score of 3 or 4 indicates unsatisfactory mask acceptance during induction of general anesthesia."|During induction of general anesthesia.||||Participants|||Count of Participants
1330359|NCT02096900|Primary|Patient Anxiety at the Time of Separation|"The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures.~The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious."|Up to 24 hours including preoperative, preoperative, and postoperative periods.||||units on a scale||Inter-Quartile Range|Median
1330360|NCT02096861|Secondary|The Short Inflammatory Bowel Disease Questionnaire|"SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.~Higher values of SIBDQ represent a better patient disease outcome."|Baseline and Week 54|Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.|||scores on a scale||Standard Deviation|Mean
1330361|NCT02096861|Secondary|The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)|"SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.~Higher values of SIBDQ represent a better patient disease outcome."|Up to Week 30|"Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.~CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group"|||scores on a scale||Standard Deviation|Mean
1330362|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Remission at Week 54|Clinical remission was defined as an absolute CDAI score of less than 150 points.|Week 54||||Participants|||Count of Participants
1330363|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Remission at Week 30|Clinical remission was defined as an absolute CDAI score of less than 150 points.|Week 30|CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group|||Participants|||Count of Participants
1330364|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Remission at Week 6|Clinical remission was defined as an absolute CDAI score of less than 150 points.|Week 6|CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group|||Participants|||Count of Participants
1330365|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54|A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.|Week 54||||Participants|||Count of Participants
1330366|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30|A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.|Week 30|CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group|||Participants|||Count of Participants
1330367|NCT02096861|Primary|The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6|A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.|at Week 6|"CT-P13 treatment group including CT-P13 - CT-P13 and CT-P13 - Remicade treatment groups.~Remicade treatment group including Remicade - Remicade and Remicade - CT-P13 treatment groups."|||Participants|||Count of Participants
1330368|NCT02096835|Other Pre-specified|Need of Postoperative Metoclopramide|the number of patients who needed metoclopramide as a rescue medicine postoperatively|within 48h after operation||||participants|||Number
1330369|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively|including retching and vomiting|within 24h after operation||||participants|||Number
1330370|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively||within 24h after the operation||||participants|||Number
1330371|NCT02096835|Primary|Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively|the total number including nausea, retching and vomiting within 24h after operation|within 24h after operation||||participants|||Number
1330372|NCT02096744|Secondary|Cmax (Maximum Concentration of Clonidine in Plasma)|Cmax (maximum concentration of clonidine in plasma) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1330373|NCT02096744|Secondary|AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity)|AUC 0-inf(area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330374|NCT02096744|Primary|Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7)|Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1330375|NCT02096744|Primary|AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h)|AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330376|NCT02096731|Primary|Community Acquired Pneumonia|"The community acquired pneumonia rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.~Pt. = Patient"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.|||No.of incident Pneumonia/1000 pt./year|||Number
1330377|NCT02096731|Primary|Cardiac Arrhythmia|The cardiac arrhythmia (CA) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.|||No. of incident CA/1000patients /year|||Number
1330378|NCT02096731|Primary|Heart Failure|The heart failure (HF) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.|||No. of incident HF/1000patients/year|||Number
1330379|NCT02096731|Primary|Stroke|The stroke rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.|||No. of incident stroke/1000patients/year|||Number
1330380|NCT02096731|Primary|Myocardial Infarction|"The acute myocardial infarction (MI) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.~No. = Number"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.|||No. of incident MI/1000patients/ year|||Number
1330381|NCT02096718|Secondary|AUC 0-inf of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330382|NCT02096718|Primary|Cmax of Afatinib (BIBW 2992)|Maximum measured concentration of the analyte in plasma|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1330417|NCT02096263|Secondary|Number of Subjects With SAEs.|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the 31-day (Days 0-30) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.|||Participants|||Count of Participants
1330383|NCT02096718|Primary|AUC 0-tz of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330384|NCT02096705|Secondary|Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24|The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||International Units (IU)||Standard Error|Mean
1330385|NCT02096705|Secondary|Adjusted Mean Change in Body Weight From Baseline to Week 24|Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||kilograms||Standard Error|Mean
1330386|NCT02096705|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24|The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||mg/dL||Standard Error|Mean
1330387|NCT02096705|Primary|Adjusted Mean Change in HbA1c From Baseline to Week 24|The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||percentage of hemoglobin||Standard Error|Mean
1330388|NCT02096692|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|All participants who had measurable R-waves at both pre-MRI and and 1 Month Post-MRI.|||percentage of participants||95% Confidence Interval|Number
1330389|NCT02096692|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
1330390|NCT02096692|Primary|MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
1330391|NCT02096679|Secondary|Pharmacokinetics of AZD9291 and Urine [14C] Total Radioactivity by Assessment of Percentage (or Fraction) of Actually Administered Dose / Radioactivity (Feu)|Pharmacokinetics of AZD9291 and urine [14C] total radioactivity by assessment of percentage (or fraction) of actually administered dose / radioactivity (feu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Percentage of administered dose||Standard Deviation|Mean
1330392|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Urine [14C] Total Radioactivity by Assessment of Urine Concentration or Concentration Equivalent x Urine Volume (Aeu)|Pharmacokinetics of AZD9291, its metabolites and urine [14C] total radioactivity by assessment of urine concentration or concentration equivalent x urine volume (Aeu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nmol||Standard Deviation|Mean
1330393|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve AUC|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve AUC, derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
1330394|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of WBR to PR (AUC(WBR)/AUC(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of WBR to PR (AUC(WBR)/AUC(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
1330395|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of Plasma AZD9291, AZD7550 or AZD5104 (PL) to Plasma Radioactivity (PR) AUC(PL)/AUC(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of plasma AZD9291, AZD7550 or AZD5104 (PL) to plasma radioactivity (PR) AUC(PL)/AUC(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
1338583|NCT01961115|Secondary|Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0_v2||Up to 1 year|Data were not collected||||||
1330396|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Whole Blood Radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of whole blood radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
1330397|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Plasma AZD9291, AZ7550 or AZ5104 (PL) to Plasma Radioactivity (Cmax(PL)/Cmax(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of plasma AZD9291, AZ7550 or AZ5104 (PL) to plasma radioactivity (Cmax(PL)/Cmax(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
1330398|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Metabolite to Parent Ratio, AZ7550 or AZ5104 (M/PCmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax metabolite to parent ratio, AZ7550 or AZ5104 (M/PCmax), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
1330399|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Metabolite to Parent Ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC Adjusted for Differences in Molecular Weight (M/PAUC)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC metabolite to parent ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC adjusted for differences in molecular weight (M/PAUC), derived from the curves taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Ratio||Full Range|Geometric Mean
1330400|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Rate Constant (λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination rate constant (λz), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||1/h||Full Range|Geometric Mean
1330401|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Half-life (t1/2,λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination half-life (t1/2,λz), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||hour||Full Range|Mean
1330402|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Volume of Distribution (Vz/F)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of apparent volume of distribution (Vz/F), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L||Full Range|Mean
1330403|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Oral Clearance (CL/F)|Pharmacokinetics of AZD9291 plasma, whole blood and plasma [14C] radioactivity by assessment of apparent oral clearance (CL/F), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L/h||Full Range|Mean
1330404|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Lag Time Before Observation of Quantifiable Analyte Concentrations (Tlag)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of lag time before observation of quantifiable analyte concentrations (tlag), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||hours||Inter-Quartile Range|Median
1338787|NCT01958346|Secondary|Sore Throat Grade on First Postoperative Day|Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe|Postoperative day one||||participants|||Number
1330405|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Time to Cmax (Tmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of by assessment of time to Cmax (tmax), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||hours||Inter-Quartile Range|Median
1330406|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Maximum Plasma Concentration (Cmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of maximum plasma concentration (Cmax), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM||Full Range|Geometric Mean
1330407|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to 24 Hours AUC(0-24)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 24 hours AUC(0-24), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
1330408|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of 72 Hours AUC(0-72)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 72 hours AUC(0-72), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
1330409|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration AUC(0-t)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-t), derived from the curve taken during the treatment period.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
1330410|NCT02096679|Primary|Percentage of Radioactive Dose of [14C] Radiolabelled AZD9291 Recovered in Urine, Faeces, and in Total.|The percentage of radioactive dose of [14C] radiolabelled AZD9291 recovered in urine, faeces, and in total, up to Day 85.|Blood samples (hrs) – 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992. Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016. Faeces: 0-24h and then as per urine.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Percentage radioactive dose recovered||Standard Deviation|Mean
1330411|NCT02096575|Secondary|Visual Analog Scale to Measure Anticipated Pain.|Anticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Anticipated pain assessed on average within 30 minutes before procedure||||units on a scale||Standard Deviation|Mean
1330412|NCT02096575|Secondary|Pain Management Satisfaction|Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.||||units on a scale||Standard Deviation|Mean
1330413|NCT02096575|Secondary|Visual Analog Scale for Post-procedure Pain|A quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale administered on average 20 minutes after procedure completed||||units on a scale||Standard Deviation|Mean
1330414|NCT02096575|Secondary|Visual Analog Scale Score for Baseline Pain|A quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Baseline pain assessment on average within 30 minutes before procedure||||units on a scale||Standard Deviation|Mean
1330415|NCT02096575|Primary|Visual Analog Pain Score for Mean Maximum Procedural Pain|"The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed.~Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain"|Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure||||units on a scale||Full Range|Mean
1330416|NCT02096458|Primary|Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets|The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.|Day 1|The populations consisted of all enrolled participants.|||Seconds||Full Range|Mean
1331701|NCT02074059|Primary|Peri-Dosing Events|Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone|Within 48 Hours after Initiation of Study Treatment|Safety Population|||participants|||Number
1330418|NCT02096263|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.|||Participants|||Count of Participants
1330419|NCT02096263|Secondary|Number of Subjects With Specific AEs.|Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)|During the 31-day (Days 0-30) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.|||Participants|||Count of Participants
1330420|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.|||Participants|||Count of Participants
1330421|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.|||Participants|||Count of Participants
1330422|NCT02096263|Secondary|Antibody Concentrations for Anti-HBs.|Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
1330423|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-HBs.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330424|NCT02096263|Secondary|Antibody Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||titres||95% Confidence Interval|Geometric Mean
1330425|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330426|NCT02096263|Secondary|Antibody Concentrations for Anti-PRP.|Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
1330427|NCT02096263|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.|The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330428|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-PRP.|A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330447|NCT02096263|Secondary|Antibody Concentrations for Anti-HBs.|Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
1330429|NCT02096263|Secondary|Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.|"Booster response to PT, FHA and PRN antigens was defined as:~For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off.~For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration.~For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration.~The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN."|At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330430|NCT02096263|Secondary|Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.|At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1330431|NCT02096263|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositve subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.|At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330432|NCT02096263|Secondary|Antibody Concentrations for Anti-D.|Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1330433|NCT02096263|Secondary|Antibody Concentrations for Anti-T.|Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1330434|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-D.|A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330435|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-T.|A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
1330436|NCT02096263|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 up to 6 months post-primary vaccination (Month 10)|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1330437|NCT02096263|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-primary vaccination period.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1330438|NCT02096263|Secondary|Number of Subjects With Specific Adverse Events (AEs).|Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)|From Month 0 up to 6 months post primary-vaccination (Month 10)|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1330448|NCT02096263|Secondary|Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
1331169|NCT02082184|Secondary|Number of Glucose Measurements Performed|Number of blood glucose fingerstick tests per day by intervention and control group during days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208.|Days 15 to 208||||number of measurements per day||Standard Deviation|Mean
1330439|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following any dose.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330440|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following Dose 3.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330441|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following Dose 2.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330442|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following Dose 1.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330443|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-vaccination period following any dose.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330444|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA|During the 4-day (Days 0-3) post-vaccination period following Dose 3|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330445|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-vaccination period following Dose 2|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330446|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-vaccination period following Dose 1|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
1330449|NCT02096263|Secondary|Antibody Concentrations for Anti-PRP.|Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
1330450|NCT02096263|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.|The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
1330451|NCT02096263|Secondary|Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
1330452|NCT02096263|Secondary|Antibody Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||titres||95% Confidence Interval|Geometric Mean
1330453|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
1330454|NCT02096263|Secondary|Antibody Concentrations for Anti-D.|Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1330455|NCT02096263|Secondary|Antibody Concentrations for Anti-T.|Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1330456|NCT02096263|Secondary|Number of Seroprotected Subjects Against Diphtheria (D).|A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
1330457|NCT02096263|Secondary|Number of Seroprotected Subjects Against Tetanus (T).|A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
1330458|NCT02096263|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositve subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
1330459|NCT02096263|Primary|Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1330460|NCT02096107|Secondary|Infection|Compare the rates of post-transplant infections, including CMV, BK, and admissions to the hospital for infectious causes in each group.|2 year||||percentage of subjects with infection|||Number
1330461|NCT02096107|Secondary|Adverse Drug Reactions|Measure and compare the incidence of significant immunosuppressant-related adverse drug reactions for each group.|2 year||||Participants|||Count of Participants
1330462|NCT02096107|Secondary|Percentage of Participants Discontinuing or Modifying Immunosuppressant Use|Measure and compare the rates of immunosuppressant discontinuation and modification for each group.|2 year||||percentage of participants|||Number
1330463|NCT02096107|Secondary|Kidney Allograft Survival|Compare the patient and graft survival rates at one-year post-transplant in each group.|1 year||||percentage of patients graft survival|||Number
1331170|NCT02082184|Secondary|Time Spent >180 mg/dL and >240 mg/dL|Difference in time >180 mg/dL and >240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208||||hours per day||Standard Deviation|Mean
1330464|NCT02096107|Secondary|Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR)|Measure and compare the estimated GFR (using the 4-variable modified MDRD equation) in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen, both at one year and two years post-transplant.|1 year||||mL/min/1.73 m^2||Standard Deviation|Mean
1330465|NCT02096107|Primary|Kidney Allograft Fibrosis Assessment|"Measure and compare the change in interstitial fibrosis (morphometric analysis of trichrome stained slides) at one-year post-transplant in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen.~The scale is a percentage of the tissue that demonstrates fibrosis. The scale range is 0 to 100%. The higher the percentage, the worse the fibrosis and the poorer the prognosis. A lower score (percentage) is therefore better."|1 year|The number of subjects analyzed for the fibrosis assessment was 15 in each group, because biopsy samples for both baseline and end of follow-up were only able to be obtained from 15 subjects per group.|||% of fibrosis||Inter-Quartile Range|Mean
1330466|NCT02096081|Secondary|Subject Perception of Treatment Peak Effect|Assessment of subject perception of date of treatment peak effect using a take-home diary|Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
1330467|NCT02096081|Secondary|Subject Perception of Treatment Onset|Assessment of subject perception of date of treatment onset using a take-home diary|Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||days||Full Range|Median
1330468|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 4 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|4 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
1330469|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 3 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|3 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
1330470|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 2 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|2 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
1330471|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 1 month from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|1 month from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
1330472|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 4 months from treatment.|4 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330473|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 3 months from treatment.|3 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330474|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 2 months from treatment.|2 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330475|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 1 month from treatment.|1 month from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330476|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 4 months from baseline.|4 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330477|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 3 months from baseline.|3 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330478|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 2 months from baseline.|2 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330479|NCT02096081|Primary|Efficacy, Measured as the Percentage of Participants Who Responded to Treatment|Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.|1 Month from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
1330480|NCT02096042|Primary|Overall Response Rate|Response defined as number of participants with complete response (CR), CR with incomplete platelet recovery (CRp), CR with insufficient hematological recovery (CRi) or partial remission (PR).|Response assessed after four 28-day cycles, up to 120 days|Study was stopped with only one participant; no analysis done on outcome.||||||
1330481|NCT02096042|Primary|Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination With 5-Azacytidine|MTD defined as maximum dose at which <33% of patients experience a dose-limiting toxicity (DLT) during cycle 1.|After 1, 28 day cycle|Study terminated early.||||||
1330482|NCT02095873|Other Pre-specified|Aortal Pulse Wave Velocity (aPWV)|Aortal pulse wave velocity is measured by a non-invasive oscillometric device.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|Subjects for which PWV data were obtained at baseline and post 8-weeks treatment.|||m/s||Inter-Quartile Range|Median
1330483|NCT02095873|Secondary|Flow-mediated Dilatation (FMD)|Brachial artery FMD will be assessed. Ultrasound imaging of the brachial artery will be performed. Percent FMD will be calculated using the averaged minimum mean brachial artery diameter at baseline compared to the largest mean values obtained after either release of the forearm occlusion.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|All subjects completing the study per protocol|||percentage of baseline value||Inter-Quartile Range|Median
1330484|NCT02095873|Secondary|Finger-fold Capillary Density by Capillaroscopy|After 20 min seated at rest, measurements are made with the subject seated and the left hand at heart level. Nail-fold capillaries in the dorsal skin of the third finger are visualized using a stereo microscope linked to a monochrome digital camera. Capillary density is defined as the number of capillaries per mm2 of nail-fold skin and is computed as the mean of 4 measurements.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|All subjects with where baseline and post-8 treatment data were obtained.|||number of capillaries per mm2||Inter-Quartile Range|Median
1330485|NCT02095873|Primary|Area Under the Curve for Oral Glucose Tolerance Test (oGGT)|A standard 75 g glucose oGTT will be performed, as routinely used in clinical practice. Participants will be instructed to eat carbohydrate rich diet (> 150 g/day) for at least three days before the test, followed by an overnight fast. Participants will be instructed to have comparable macronutrient composition of the dinner before the respective study days in the metabolic unit. During the oGTT both capillary and venous blood samples will be collected after 0, 15, 30, 60, 90 and 120 min. To minimize the inconvenience of repeated blood tests during the oGTT, a venous cannula will be inserted, under sterile conditions, prior to the test, for blood sampling.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|Highly overweight/obese (BMI>27.5 kg/m2) subgroup, based on subject BMI at study entry.|||mM h||Standard Error|Mean
1330486|NCT02095691|Secondary|Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.|||percentage of participants|||Number
1330487|NCT02095691|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.|||percentage of participants|||Number
1330488|NCT02095691|Secondary|Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.|||mmHg||Standard Deviation|Mean
1330623|NCT02093923|Secondary|Apparent Clearance (CL/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||liters/day||Standard Deviation|Mean
1330489|NCT02095691|Secondary|Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The safety analysis population consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
1330490|NCT02095691|Primary|Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.|Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
1330491|NCT02095561|Secondary|HPV Positivity|Calculated as the percentage of women with positive HPV test over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within 6 months after the CHW visits|Population included in the HPV self-testing group to calculate positivity includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.|||percentage of positive tests/tested wome|||Number
1330492|NCT02095561|Secondary|CIN2+ Detection Rate|calculated as the percentage of women with histologically confirmed CIN2+ over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within one year after the CHW visits|Population included in the HPV self-testing group to calculate CIN2+ detection rate includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.|||percentage of CIN2+/ women screened|||Number
1330493|NCT02095561|Secondary|Acceptability|Defined as the proportion of women from the intervention group who were offered self-testing and accepted, as documented in the questionnaire, independently of if they ended up with a test in the information system.|within 6 months||||participants|||Number
1330494|NCT02095561|Primary|Screening Uptake|The primary outcome was screening uptake, defined as: a) the proportion of participant women with any HPV test (self-test or HPV at health centers) in the information system, in the 6 months after the CHW visit, and b) the proportion of women in the intervention group with a self-test in SITAM, in the same 6 month period.|within 6 months after the intervention||||participants|||Number
1330495|NCT02095535|Primary|Length of Drying Time|Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.|At Chloraprep application||||seconds||Standard Deviation|Mean
1330496|NCT02095223|Secondary|Change From Baseline in Quadriceps Hoffmann Reflex|We will record muscle reflex activity by delivering a short percutaneous (through the skin) electrical stimulation to femoral nerve located in the inguinal fold. We will measure the reflex response of the quadriceps with surface electromyography. Subjects will be positioned comfortably in a lying-down position on a treatment table. Stimuli will be delivered to the femoral nerve by increasing the intensity in small increments with a 10-sec rest interval after each stimulus, until the maximum H-reflex amplitude is recorded (Hmax). The H-reflex represents the proportion of the quadriceps motor neuron pool that is available for voluntary contraction and the M-wave represents the total volume of the quadriceps motor neuron pool and will be used to normalize the H-reflex recordings as H:M ratio. This measurement will be performed bilaterally.|Baseline and 14 days|This measure was exclude from the study protocol due to an issue with the equipment utilized to generate the electical pulse. No participants of this study completed the Hoffmann reflex testing protocol at baseline or follow-up visits.||||||
1330497|NCT02095223|Primary|Change From Baseline in Quadriceps Central Activation Ratio|Subjects will be secured to a chair (Biodex multi-mode dynamometer) with their knees and hips bent to approximately 90-degrees. Subjects will perform a maximal, voluntary isometric knee extension contraction (MVIC) with continuous verbal encouragement from the tester. Once the MVIC reaches a plateau (representing subjects' maximal effort) an electrical stimulus will be manually triggered and delivered directly to the quadriceps through 2 stimulating electrodes which will be secured to the subjects' anterior thigh. The stimulus will cause the quadriceps to twitch resulting in a temporary increase in force production which we will measure. A ratio between the MVIC force and the highest force achieved due to the electrical stimulation will be calculated - this is called the central activation ratio.|Baseline and 14 days||||percentage change from baseline||Standard Deviation|Mean
1330498|NCT02095197|Secondary|Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score|This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent.|1 month|Both demonstrate a difference from pretreatment baseline (P=0.05).|||Participants|||Count of Participants
1330499|NCT02095197|Secondary|Patient Global Impression of Change Score (PGIC) Less Than 3|"PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as:~1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse.~A PGIC score less than 3 means the patient reported much improved to very much improved."|1 month||||Participants|||Count of Participants
1330518|NCT02094898|Secondary|CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation|The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
1330500|NCT02095197|Secondary|Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)|The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject’s medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus).|1 month||||Participants|||Count of Participants
1330501|NCT02095197|Primary|Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain|"The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period.~Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain).~Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)"|1 month||||percentage of participants||95% Confidence Interval|Number
1330502|NCT02095158|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales|The investigator assessed the participant’s overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 6-hour evaluation period (hours 3 and 6) post-dose.|Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose|Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement.|||percentage of participants|||Number
1330503|NCT02095158|Primary|Percentage of Participants With Treatment-Related Adverse Events|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.|56 Weeks|Safety population included all participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1330504|NCT02095106|Other Pre-specified|Patient Satisfaction|Patient satisfaction with the treatment was measured at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) with a survey that was presented to the patient or parent, asking them to rate the satisfaction on a scale from 1 (less satisfied) to 100 (more satisfied).|4 weeks post-injury||||units on a scale||Full Range|Mean
1330505|NCT02095106|Other Pre-specified|Pain|Pain was evaluated at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) using the Faces Pain Scale, a validated, highly reliable scale commonly used in the pediatric population. The Faces Pain Scale is a numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of “no pain” (0) to “very much pain” (10). Participant is asked to point to the face that shows how much participant hurts at the time of assessment [right now].|4 weeks post-injury||||score||Full Range|Mean
1330506|NCT02095106|Other Pre-specified|Physical Function|Physical function was evaluated using the Activities Scale for Kids - Performance (ASKp) at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) - to ensure that the measurement represented only the time in which the participant received each type of intervention. The ASKp is a validated, highly reliable, self-reported measure that assesses physical function in children between 5 and 15 years. Scale ranges from 0 to 100 with higher scores representing more physical activity.|4 weeks post-injury||||units on a scale||Full Range|Mean
1330507|NCT02095106|Other Pre-specified|Itchiness|"Itchiness was assessed using a visual analog scale at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type). This scale consisted of a horizontal line of 100 mm presented to the patient, with the term no itching at the left end of the scale and the term strong itching appearing at the right end of the scale."|4 weeks post-injury||||units on a scale||Full Range|Mean
1330508|NCT02095106|Secondary|Number of Participants Without Skin Irritation at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type)|Skin changes were assessed after removal of the cast by an independent observer blinded to the type of cast that had been removed, with digital photographs obtained and analyzed using Image J Image Processing and Analysis Software to calculate the surface area of any described skin changes as a percentage of total skin area originally covered by the cast.|4 weeks post-injury||||Participants|||Count of Participants
1330509|NCT02095106|Primary|Number of Participants Without Fracture Displacement at 8 Weeks Post Injury|The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.|8 weeks post injury||||Participants|||Count of Participants
1330510|NCT02094937|Secondary|Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20)|Asthma control test is a five item questionnaire with each response rating from 1 to 5 (1 is severe and 5 is no event) of asthma events over previous 4-weeks. The questions were designed to be self-completed by the participant. The percentage of participants with ACT score >=20 at the end of the Period 2 were analyzed using a logistic regression model including covariates for baseline ACT score, gender, age and treatment group.|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.|||Percentage of participants||95% Confidence Interval|Number
1331291|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1330511|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2|The total ACT score is the sum of the scores attributed to the five questions, ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >=20 indicates well-controlled asthma. The questions were designed to be self-completed by the participant. Mean change from Baseline was calculated as ACT score at the end of Period 2 (Week 20) minus Baseline value. The Baseline value was the predose value at randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean(LSM)].|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.|||Score on scale||Standard Error|Least Squares Mean
1330512|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2|The time during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Participants who did not require inhalation of salbutamol (rescue medication) for 24-hours were captured with the help of a daily dairy, all participants were required to record use of rescue medication daily for day and night time separately on e-diary. Mean change from Baseline was calculated as percentage of rescue free 24 hour period during Period 2 (Week 9 to Week 20) minus Baseline value. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1330513|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2|Participants who were symptom free for 24-hours were assessed with the help of a daily Dairy. It included the details on daily asthma symptom scores ranging from 0 (no symptoms) to 5-symptoms so severe that participant could not perform normal activity [morning] or to 4-symptoms so severe that participants could not sleep at all [nightly]. Mean change from Baseline was calculated as percentage of symptom free 24 hours during Period 2 (Week 9 to Week 20) minus Baseline. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed|||Percentage of symptom-free 24-h period||Standard Error|Least Squares Mean
1330514|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2|Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter which determines person's ability to breathe out air. PEF was measured each morning and evening prior to study medication or any rescue salbutamol inhalation aerosol use, using an electronic peak flow meter. Mean change from Baseline was calculated as PEF value averaged during Period 2 (Week 9 to Week 20) minus Baseline. Data is presented separately for morning(AM) and evening(PM) assessments. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8) separately for morning and evening. Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified timepoints were analyzed|||Liter per minute (L/min)||Standard Error|Least Squares Mean
1330515|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2|FEV measures amount of air a person can exhale during a forced breath. The amount of air exhaled in one second of the forced breath is FEV1. Trough FEV1 was measured between 3pm and 11pm excluding Visit 1. Highest value from the three acceptable measurements were recorded. Change from Baseline was calculated as adjusted mean FEV1 value during Period 2 minus Baseline. The Baseline value was the predose value at the randomization (Visit 5: Week 8). Analysis of covariance (ANCOVA) Model was used with covariates of baseline FEV1, gender, age and treatment group. The adjusted mean from this model is presented [least square mean (LSM)].|Week 20|ITT population. Number of participants available for the last post-baseline value during Period 2 were used for analysis.|||Liter||Standard Error|Least Squares Mean
1330516|NCT02094937|Primary|Percentage of Participants With 'Well-controlled Asthma' at the End of Period 2|Asthma symptom scores(SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity[morning] or to 4-symptoms so severe that par could not sleep at all[nightly]. “Well-controlled asthma” was defined as having no exacerbation/asthma worsening, no night-time symptoms, a best pre-bronchodilator forced expiratory volume in 1 second ≥80% at clinic, and ≥2 per week of: daytime symptoms on ≤1 day, rescue use on ≤1 day, or morning peak expiratory flow ≥80% of the best effort value. “Well-controlled asthma” at the end of period 2 was assessed in the week prior to Visit 11 (Week 20). Percentage of participants were calculated as the number of participants with “well-controlled asthma” divided by total number participants excluding withdrawals prior to visit 11 (end of period 2) other than asthma worsening/exacerbation. A Logistic Regression Model was used with covariates of Baseline FEV1, gender, age and treatment group.|Week 20|ITT population. Participants who withdrew prior to Visit 11 for the reasons other than exacerbation were excluded.|||Percentage of Participants||95% Confidence Interval|Number
1330517|NCT02094937|Primary|"Percentage of Participants (Par) Withdrawn From the Study Due to Poorly-controlled Asthma During Period 2"|Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity [morning] or to 4-symptoms so severe that par could not sleep at all [nightly]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF <80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) < 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced.|From Week 9 to Week 20|Intent-to-treat (ITT) population defined as participants randomized to treatment and who received at least one dose of randomized study medication in Period 2.|||Percentage of Participants||95% Confidence Interval|Number
1331292|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1330519|NCT02094898|Secondary|Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation|The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
1330520|NCT02094898|Secondary|MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
1330521|NCT02094898|Secondary|MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
1330522|NCT02094898|Secondary|MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
1330523|NCT02094898|Secondary|MADRS Factor 4 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion|||units on a scale||Standard Deviation|Mean
1330524|NCT02094898|Secondary|MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
1330525|NCT02094898|Secondary|MADRS Factor 3 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
1330526|NCT02094898|Secondary|MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
1330527|NCT02094898|Secondary|MADRS Factor 2 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
1330528|NCT02094898|Secondary|MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
1330529|NCT02094898|Secondary|MADRS Factor 1 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
1338788|NCT01958346|Primary|Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.||At Intubation||||participants|||Number
1330530|NCT02094898|Secondary|MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation|The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
1330531|NCT02094898|Primary|MADRS Total Score at Baseline and Last Acute Phase Observation|The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
1330532|NCT02094885|Secondary|Percentage of Participants With Potential Bleeding-related Adverse Events|Percentage of participants with potential bleeding-related adverse events by study group|30-days follow-up||||percentage of participants||95% Confidence Interval|Number
1330533|NCT02094885|Secondary|Number of Participants Requiring Alternative Treatment Due to Treatment Failure*|Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.|Intra-operative, 10 minutes following randomization||||participants|||Number
1330534|NCT02094885|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application|Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.|Intra-operative, 3 and 6 minutes following randomization||||percentage of participants||95% Confidence Interval|Number
1330535|NCT02094885|Primary|Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.|Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.|Intra-operative, 10 minutes following randomization||||percentage of patients||95% Confidence Interval|Number
1330536|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||units on a scale||Standard Deviation|Mean
1330537|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||units on a scale||Standard Deviation|Mean
1330538|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) – Filcon II 3 and Nelfilcon A|"The ophthalmologist’s objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).~N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||percentage of the area of each zone||Standard Deviation|Mean
1330539|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) – Filcon II 3 and Etafilcon A|"The ophthalmologist’s objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).~N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||percentage of the area of each zone||Standard Deviation|Mean
1330540|NCT02094677|Secondary|High Contrast Visual Acuity – Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||logMAR||Standard Deviation|Mean
1330541|NCT02094677|Secondary|High Contrast Visual Acuity – Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||logMAR||Standard Deviation|Mean
1330542|NCT02094677|Secondary|Lens Surface Deposition – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||units on a scale||Standard Deviation|Mean
1330543|NCT02094677|Secondary|Lens Surface Deposition – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||units on a scale||Standard Deviation|Mean
1330544|NCT02094677|Secondary|Lens Fit, Tightness – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||percentage of tightness||Standard Deviation|Mean
1330545|NCT02094677|Secondary|Lens Fit, Tightness – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||percentage of tightness||Standard Deviation|Mean
1330546|NCT02094677|Secondary|Lens Fit, Post-Blink Movement – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||mm steps||Standard Deviation|Mean
1330547|NCT02094677|Secondary|Lens Fit, Post-Blink Movement – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||mm steps||Standard Deviation|Mean
1330548|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|After 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||participants|||Number
1330549|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|Baseline|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||participants|||Number
1330550|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||participants|||Number
1330551|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|"The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).~N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||participants|||Number
1330552|NCT02094677|Secondary|Lens Wettability – Filcon II 3 and Nelfilcon A|The ophthalmologist’s objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||units on a scale||Standard Deviation|Mean
1330553|NCT02094677|Secondary|Lens Wettability – Filcon II 3 and Etafilcon A|The ophthalmologist’s objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||units on a scale||Standard Deviation|Mean
1330554|NCT02094677|Secondary|Lens Handling (Removal) – Filcon II 3 and Nelfilcon A|Participant’s subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330555|NCT02094677|Secondary|Lens Handling (Removal) – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330556|NCT02094677|Secondary|Lens Handling – Filcon II 3 and Nelfilcon A|Participant’s subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330557|NCT02094677|Secondary|Lens Handling – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330558|NCT02094677|Secondary|Lens Dryness - Filcon II 3 and Nelfilcon A|Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330559|NCT02094677|Secondary|Lens Dryness – Filcon II 3 and Etafilcon A|Participant’s subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330560|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Nelficon A|Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330561|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Etafilcon A|Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
1330562|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|6 hours||||participants|||Number
1330563|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|3 hours||||participants|||Number
1330564|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|"Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.~(5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A)."|Baseline visit||||participants|||Number
1330565|NCT02094664|Secondary|Duration of O2 Use|Duration on supplemental O2 was measured in hours.|Subjects will be followed for the duration of oxygen requirement until oxygen discontinued||||hours||Standard Deviation|Mean
1330566|NCT02094664|Secondary|Length of Hospital Stay|Length of hospital stay is measured in days and counted from day of admission to day of discharge.|Subjects will be followed for the duration of hospital stay until discharge||||days||Standard Deviation|Mean
1330567|NCT02094664|Primary|Change in Respiratory Rate (RR) From Baseline|Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.|Baseline, Hour 1, Hour 4, Hour 8, and Hour 12||||breaths per minute||Standard Deviation|Mean
1330568|NCT02094664|Primary|Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.|The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.|Baseline, Hour 1, Hour 4, Hour 8, and Hour 12||||units on a scale||Standard Deviation|Mean
1330569|NCT02094612|Secondary|Other Health Services Use|"Update: Outcome measure reported is number of psychiatric and ED visits during the 6 month follow up period.~Use of healthcare services outside of pediatrics, including the emergency room and psychiatric services."|Baseline to six months||||visits|||Number
1330570|NCT02094612|Secondary|Satisfaction With Care|"Update: Outcome measure reported is number of participants who responded very satisfied with their ADHD care on 5-point Likert scale.~Likert scale single item measure of how satisfied the pediatric patient's parent was with care received"|Six months||||Participants|||Count of Participants
1330571|NCT02094612|Secondary|Medication Adherence|"Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits.~Sustained use of ADHD medication"|Baseline to six months||||Participants|||Count of Participants
1330572|NCT02094612|Secondary|Persistence in Care|"Update: Outcome measure reported is the # of participants who attended all study follow-up visits.~Use of pediatric health care services"|Baseline to Six Months||||Participants|||Count of Participants
1330573|NCT02094612|Secondary|Academic Performance|Academic performance will be measured by student report cards, and converted to a standardized scale|Baseline and Six Months|Academic performance was not measured, as there were a very low number of report cards collected (11 of 25 in Quotient arm and 16 of 33 in UC arm).||||||
1330574|NCT02094612|Secondary|ADHD Symptomatology|"Outcomes reported are average SNAP IV scores at baseline and 6 monhts. ADHD symptomatology is measured by the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), developed by James Swanson, Edith Nolan and William Pelham. We used the 18-item self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) symptoms in children and young adults. Each question measures the frequency of a variety of symptoms or behaviors.The subscales measure Inattention (9 items) and Hyperactivity/impulsivity (9 items), using 0-3 rating, 0=not at all, 1=just a little, 2=quite a bit, or 3=very much. Each 9-item subscale results in a score in range 0-27. The two subscale scores were averaged to create a single score for the 18-item SNAP."|6 months post baseline||||Score on a scale||Standard Deviation|Mean
1330624|NCT02093923|Secondary|Area Under the Plasma Concentration-time Curve (AUC)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||day*ng/mL||Standard Deviation|Mean
1330575|NCT02094612|Primary|Number of Participants With 25% Reduction in SNAP Scores|Outcome measure reported is the number of participants with at least one 25% reduction in SNAP between visits. In treatment of ADHD, the therapeutic dose is defined as a 25% reduction in SNAP IV score between consecutive clinic visits. SNAP is itemized rating scale (Swanson, Nolan, and Pelham-IV Questionnaire) designed to measure ADHD symptoms and severity on a 4 point scale. It is based on DSM IV criteria, and is designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults ages 6–18.|One month, 3 month and six month follow ups|Fifty eight (58) participants completed the study (i.e., had their 6 month follow up appointment) when the study was terminated.|||Participants|||Count of Participants
1330576|NCT02094573|Secondary|Patient-reported Symptoms Global Health Status/Quality of Life (QoL) Scores|"Patient-reported symptoms global health status/quality of life (QoL) scores were based on questions 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30). The first 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and last 2 questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Six single-item scales also are included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores for multi-item scales and single-item measures will be linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher (better) level of functioning."|Up to 30 days after the last dose of study drug or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, n represents number of participants who were evaluable at specific time point.|||unit on a scale||Standard Deviation|Mean
1330577|NCT02094573|Secondary|Pre-dose Brigatinib Plasma Concentration||Day 1 Cycle 1 pre-dose; Cycle 2 pre-dose and at multiple time points (up to 6-8 hours) post dose; Cycles 3, 4 and 5 pre-dose and at 1-8 hours post dose|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/ml||Standard Deviation|Mean
1330578|NCT02094573|Secondary|Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug up to 30 days following the last dose of study drug (up to 20 months)|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
1330579|NCT02094573|Secondary|Overall Survival (OS)|OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. Intracranial OS was calculated by Kaplan-Meier estimation.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||months||95% Confidence Interval|Median
1330580|NCT02094573|Secondary|Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader).|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||months||95% Confidence Interval|Median
1330581|NCT02094573|Secondary|Disease Control Rate|Disease control rate (DCR) is defined as the proportion of randomized participants who were confirmed to have achieved CR or PR or have a best overall response as stable disease (SD) for 6 weeks or more after initiation of the study drug. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||percentage of participants||95% Confidence Interval|Number
1330582|NCT02094573|Secondary|Time on Treatment|Time on treatment is defined as the time from the first to the last dose of study drug. For participants who have not discontinued, time on treatment was censored as of the last dose of the study drug.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|Safety population included all participants who received at least one dose of study drug.|||days||Standard Deviation|Mean
1330607|NCT02094261|Secondary|Progression-Free Survival (PFS)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment.|||months||95% Confidence Interval|Median
1330583|NCT02094573|Secondary|Duration of Response|Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the progressive disease is objectively documented or death. Patients without progressive disease or death were censored at the last valid response assessment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants who had confirmed CR or PR were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1330584|NCT02094573|Secondary|Time to Response|Time to response is defined as the time interval from the date of the first dose of the study drug until the initial observation of CR or PR for participants with confirmed CR/PR. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants who had confirmed CR or PR were evaluable for this outcome measure.|||months||Full Range|Median
1330585|NCT02094573|Secondary|Intracranial CNS Progression Free Survival (PFS) in Participants With Active Brain Metastases|Intracranial CNS PFS as evaluated by IRC is defined as the time interval from the date of the first dose of the study drug until the first date at which intracranial CNS disease progression, an increase of 20% or more in the sum of diameters of intracranial CNS target lesions, unequivocal progression of non-target lesions, or the appearance of new lesions in the intracranial CNS, was objectively documented by a scan, or death due to any cause, whichever occurred first.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with active brain metastases at baseline were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
1330586|NCT02094573|Secondary|Confirmed Intracranial Central Nervous System Objective Response Rate (CNS ORR) in Participants With Only Non-measurable Active Brain Metastases|Confirmed intracranial CNS ORR is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 as evaluated by IRC after the initiation of study drug. Confirmed responses were those that persisted on repeat imaging 4 weeks or more after initial response. CR for target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis). CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date:29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with only non-measurable active brain metastases at baseline were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1330587|NCT02094573|Secondary|Confirmed Intracranial Central Nervous System Objective Response Rate (CNS ORR) in Participants With Measurable Active Brain Metastases|Confirmed intracranial CNS ORR is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 as evaluated by IRC after the initiation of study drug. Confirmed responses were those that persisted on repeat imaging 4 weeks or more after initial response. CR for target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis). CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date:29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with measurable active brain metastases at baseline were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1330588|NCT02094573|Secondary|Confirmed Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)|ORR assessed by the IRC, is defined as the proportion of the participants with confirmed Clinical response (CR) or partial response (PR) according to RECIST v1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 95% confidence interval was calculated.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||percentage of participants||95% Confidence Interval|Number
1330589|NCT02094573|Primary|Confirmed Objective Response Rate (ORR) as Assessed by Investigator|ORR assessed by the investigator, is defined as proportion of the participants with confirmed Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 (confirmed ≥4 weeks after initial response), after initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 97.5% confidence interval was calculated. The treatment regimen was considered to have achieved the primary objective when lower bound of the 97.5% confidence interval for ORR assessed by investigator is greater than 20%.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|Intention to Treat (ITT) Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||percentage of participants||97.5% Confidence Interval|Number
1330590|NCT02094534|Secondary|Mean Nighttime, Daytime, and Fasting Glucose Levels|Mean glucose levels (by continuous glucose monitoring (CGM)) in Type 1 diabetes patients treated with ORMD-0801, compared to the mean glucose levels (by continuous glucose monitoring) for patients treated with placebo.|last two days (day 6 and day 7, averaged)|Intent to treat (ITT) population; This measurement is reported for those subjects who had at least 80% of the CGM readings. This explains why there are two fewer subjects from the ITT population reported for this endpoint.|||mg/dL||Standard Deviation|Mean
1330591|NCT02094534|Primary|Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements|Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.|Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)|Intend-to-treat polpulation|||mg/dL||Standard Deviation|Mean
1330592|NCT02094443|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End|ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1330593|NCT02094443|Secondary|Percentage of Participants With End of Treatment Response (ETR)|ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued).|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1330594|NCT02094443|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment|4 weeks|Full Analysis Set|||percentage of participants|||Number
1330595|NCT02094443|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment|2 weeks|Full Analysis Set|||percentage of participants|||Number
1330596|NCT02094443|Secondary|Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment|SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.|Up to 24 weeks posttreatment|Full Analysis Set|||percentage of participants|||Number
1330597|NCT02094443|Primary|Change From Baseline in Alanine Aminotransferase (ALT) at Week 12|ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.|Baseline, Week 12|Participants in the safety set with available data at the given time point|||U/L||Standard Deviation|Mean
1330598|NCT02094443|Primary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12|The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.|Baseline, Week 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1330599|NCT02094352|Primary|Pain Reduction|Evidence of changes in NRS pain scores between baseline and six months post infusion|6 months post infusion|Study terminated early due to lack of enrollment. We did not analyze any data.||||||
1330600|NCT02094326|Secondary|Exposure Time of Methotrexate|methotrexate|6 years||||months||Standard Deviation|Mean
1330601|NCT02094326|Secondary|Percentage of Patients Who Receive Subcutaneous Methotrexate||6 years||||percentage of participants||95% Confidence Interval|Number
1330602|NCT02094326|Secondary|Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment||6 years||||percentage of participants||95% Confidence Interval|Number
1330603|NCT02094326|Secondary|Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal||6 years||||percentage of participants||95% Confidence Interval|Number
1330604|NCT02094326|Secondary|Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question||6 years||||percentage of participants||95% Confidence Interval|Number
1330605|NCT02094326|Primary|Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice||6 years||||percentage of participants||95% Confidence Interval|Number
1330606|NCT02094300|Primary|Number of Patients With Major Complications|Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.|30 days|There were 8 patients experienced 30-day major complications.|||participants|||Number
1330608|NCT02094261|Secondary|Disease Control Rate (DCR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.|||% of participants||95% Confidence Interval|Number
1330609|NCT02094261|Secondary|Duration of Response (DoR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.|||months||Full Range|Median
1330610|NCT02094261|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.|||% of participants||95% Confidence Interval|Number
1330611|NCT02093962|Primary|Overall Survival|To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo|2 years||||Participants|||Count of Participants
1330612|NCT02093949|Secondary|Spontaneous AF at the Beginning of the Procedure|Spontaneous AF at the beginning of the procedure|baseline||||Participants|||Count of Participants
1330613|NCT02093949|Secondary|Mean LA Volume|Left Atrial volume before ablation in ml|baseline||||ml||Standard Deviation|Mean
1330614|NCT02093949|Secondary|Maximum Sustained AF Duration|duration of the longest AF epiodes in months before ablation|from first AF episode to baseline||||months|||Number
1330615|NCT02093949|Secondary|Number of Patients With Major Adverse Events During and up to 18 Months After Procedure|Adverse events|18 months post ablation|"Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation.~Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"|||participants|||Number
1330616|NCT02093949|Secondary|Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation|% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.|18 Months post ablation|"Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation.~Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"|||% of participants|||Number
1330617|NCT02093949|Secondary|Radiofrequency Time (Min)||up to 300 min||||min|||Number
1330618|NCT02093949|Secondary|% of Patients With Sinus Rhythm Conversion During the Procedure||180 min||||% of participants|||Number
1330619|NCT02093949|Primary|Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure|percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure|up to 240 min||||Percentage of participants|||Number
1330620|NCT02093923|Other Pre-specified|HAE Attack Rate Per Week|The pre-specified, primary efficacy analysis was based on subjects in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Days 8 to 50; predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and subject is a random effect in the GEE model with independence working correlation structure.|Baseline, Day 8 to Day 50|Only subjects who had a baseline attack rate of at least 2 attacks in the last 3 months prior to enrollment are included.|||attacks/week||Standard Error|Mean
1330621|NCT02093923|Secondary|Terminal Elimination Half-life (t1/2)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||days||Standard Deviation|Mean
1330622|NCT02093923|Secondary|Apparent Volume of Distribution (Vd/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||liters||Standard Deviation|Mean
1330625|NCT02093923|Secondary|Time to Maximum Plasma Concentration (Tmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||days||Standard Deviation|Mean
1330626|NCT02093923|Secondary|Maximum Plasma Concentration (Cmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||ng/mL||Standard Deviation|Mean
1330627|NCT02093923|Primary|Proportion of Patients With Serious Adverse Events|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening experience: “life-threatening” referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.~Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.~Resulted in persistent or significant disability or incapacity.~Was a congenital anomaly or birth defect.~Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with serious adverse events.|||percentage of participants|||Number
1330628|NCT02093923|Primary|Number of Patients With Serious Adverse Events (SAEs)|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening experience: “life-threatening” referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.~Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.~Resulted in persistent or significant disability or incapacity.~Was a congenital anomaly or birth defect.~Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with serious adverse events|||participants|||Number
1330629|NCT02093923|Primary|Proportion of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with Treatment-Emergent Adverse Events (TEAE)|||percentage of participants|||Number
1330630|NCT02093923|Primary|Number of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with Treatment-Emergent Adverse Events (TEAE).|||participants|||Number
1330631|NCT02093897|Secondary|Number of Subjects With Inhibitor Formation to rVIII-SingleChain|The number of subjects who develop inhibitors to rVIII-SingleChain, defined as a rVIII-SingleChain antibody titer of at least 0.6 Bethesda Units (BU) per mL after receiving study drug.|At screening, then after dosing at approximately monthly intervals for 6 months, then every 3 months until reaching 50 EDs, and at the end of study visit (up to approximately 12 months).||||participants|||Number
1330632|NCT02093897|Secondary|Clearance (Cl) of rVIII-SingleChain|Clearance (Cl) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population|||mL/h/kg||Standard Deviation|Mean
1330633|NCT02093897|Secondary|Area Under the Concentration Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUC0–t), baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population|||IU*h/dL||Standard Deviation|Mean
1330634|NCT02093897|Secondary|Half-life (t1/2) of rVIII-SingleChain|Half-life (t1/2) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population|||hour||Standard Deviation|Mean
1330635|NCT02093897|Secondary|Incremental Recovery|Incremental recovery expressed as (IU/dL)/(IU/kg) corrected for subject's predose plasma FVIII activity measured using the chromogenic substrate assay.|At 1 hour after the start of infusion|PK Population|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1330636|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Year||Up to 1 year|Subjects assigned to the on-demand treatment regimen.|||number of infusions per subject per year||Full Range|Median
1330637|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Month||Up to 1 year|Subjects assigned to the on-demand treatment regimen.|||number of infusion per subject per month||Full Range|Median
1330638|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Bleeding Event||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||IU/kg per event||Full Range|Median
1330639|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Year||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||IU/kg per subject per year||Full Range|Median
1330640|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Month||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||IU/kg per subject per month||Full Range|Median
1330641|NCT02093897|Secondary|Percentage of Bleeding Episodes Requiring 1, 2, 3, or More Than 3 Infusions of rVIII-SingleChain to Achieve Hemostasis.||Up to 1 year|Efficacy Population|||Percentage (%) of bleeding episodes|Number of Treated Bleeds||Number
1330642|NCT02093897|Secondary|Annualized Bleeding Rate|The annualized bleeding rate was defined as the number of bleeding episodes requiring treatment divided by the efficacy evaluation period in days, x 365.25, and is presented separately for the on-demand regimen and the prophylaxis regimens.|Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||Treated bleeding episodes per year||Inter-Quartile Range|Median
1330643|NCT02093897|Primary|Treatment Success|"Rate of treatment success where treatment success of a bleeding episode is defined as a rating of excellent or good based on the investigator's overall clinical assessment of hemostatic efficacy (using a 4-point scale of excellent, good, moderate or poor/no response) on the on-demand and prophylaxis regimens combined. The rate of success was based on the number of treated bleeding events; there were 347 treated bleeding events in the Efficacy Population."|Up to 1 year|Efficacy Population|||Percentage of treated bleeding events|Treated bleeding events|95% Confidence Interval|Number
1330644|NCT02093819|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1330645|NCT02093819|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax (maximum measured concentration of the analyte in plasma)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1330646|NCT02093819|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events|AEs were recorded throughout the trial|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.|||percentage of participants|||Number
1330647|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.|Baseline and 12 months||||sessions/week||Full Range|Mean
1330648|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.|Baseline and 12 months||||minutes/week||Full Range|Mean
1330649|NCT02093702|Primary|Mean Change in Diastolic Blood Pressure||Baseline and 12 months||||mm Hg||Full Range|Mean
1330650|NCT02093702|Primary|Mean Change in Total Cholesterol: HDL-C Ratio||Baseline and 12 months||||mmol/L:mmol/L||Full Range|Mean
1330651|NCT02093702|Primary|Mean Change in Triglycerides (TGs)||Baseline and 12 months||||mmol/L||Full Range|Mean
1330652|NCT02093702|Primary|Mean Change in LDL-C||Baseline and 12 months||||mmol/L||Full Range|Mean
1330653|NCT02093702|Primary|Mean Change in HDL-C||Baseline and 12 months||||mmol/L||Full Range|Mean
1330654|NCT02093702|Primary|Mean Change in Serum Total Cholesterol||Baseline and 12 months||||mmol/L||Full Range|Mean
1330655|NCT02093702|Primary|Mean Change in Body Mass Index||Baseline and 12 months||||kg/m^2||Full Range|Mean
1330656|NCT02093702|Primary|Mean Change in Waist Circumference||Baseline and 12 months||||cm||Full Range|Mean
1330657|NCT02093702|Primary|Mean Change in Systolic Blood Pressure||Baseline and 12 months||||mm Hg||Full Range|Mean
1330658|NCT02093702|Primary|Mean Change in Hemoglobin A1c (HbA1c) Levels||Baseline and 12 months||||mmol/mol||Full Range|Mean
1330659|NCT02093689|Primary|Change in Pupil Diameter|Change in pupil diameter over time from surgical baseline to the end of the surgical procedure determined by video capture during ILR.|Intraoperative|Pupil measurement methodology determined not to be appropriate in this population and data were not analyzed from any participant.||||||
1330660|NCT02093520|Secondary|Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months|Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.|||Participants|||Count of Participants
1330732|NCT02092649|Secondary|Change in Whole Body Resting Carbohydrate Oxidation From Baseline||Baseline, 6 weeks, 12 weeks||||percent change||Standard Deviation|Mean
1330733|NCT02092649|Secondary|Change in Whole Body Resting Fat Oxidation From Baseline||Baseline, 6 weeks, 12 weeks||||percent change||Standard Deviation|Mean
1330661|NCT02093520|Secondary|Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months|Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.|||Participants|||Count of Participants
1330662|NCT02093520|Primary|Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months|Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.|||Participants|||Count of Participants
1330663|NCT02093390|Secondary|Plasma Trough Concentrations for Atorvastatin|Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
1330664|NCT02093390|Secondary|Plasma Trough Concentrations for Fluconazole|Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
1330665|NCT02093390|Secondary|Fraction Excreted Unchanged (Fe) of TAK-385|Fraction of TAK-385 excreted in the urine unchanged.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||percent of TAK-385||Standard Deviation|Mean
1330666|NCT02093390|Secondary|Apparent Total Body Clearance (CL/F) of TAK-385||Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||liters/hour||Standard Deviation|Mean
1330667|NCT02093390|Secondary|Terminal Disposition Half-life (t1/2) of TAK-385|Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||hours||Standard Deviation|Mean
1330668|NCT02093390|Secondary|AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385|Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
1330669|NCT02093390|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385|Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||hours||Full Range|Median
1330670|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Laboratory Tests|Blood samples were collected for analysis of clinical chemistry and hematological parameters and urine samples were obtained for urinalysis. Clinical laboratory evaluations were performed at central and /local laboratories.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.|||participants|||Number
1330671|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings|A 12-lead ECG was administered on Days 1,9,10,11,15.|Baseline and First dose of study drug through Day 15||||participants|||Number
1330672|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Vital Signs|Vital sign measurements included oral temperature, heart rate, supine (after 3 to 5 minutes in this position) and standing (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.|||participants|||Number
1330673|NCT02093390|Secondary|Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.|||participants|||Number
1330674|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10|Area under the plasma concentration-time curve from time 0 to infinity.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
1330675|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1|Area under the plasma concentration-time curve from time 0 to infinity.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
1330676|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
1330677|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
1330678|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
1330679|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 (Predose and multiple time points up to 120 hours postdose)|Pharmacokinetic (PK)-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
1330680|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330681|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - AUC0-τ|Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330682|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330683|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - AUC0-τ|Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330684|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1330685|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ|Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||microgram x hour/millilitre (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1330686|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1330687|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - Cmax ss|Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1330688|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1330689|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - Cmax ss|Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||micrograms per millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1330734|NCT02092649|Secondary|Change in Maximum Oxygen Consumption From Baseline||Baseline, 12 weeks||||percent change||Standard Deviation|Mean
1330690|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1330691|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - Cmax ss|Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1330692|NCT02093234|Secondary|Change in Medication Adherence|Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent|baseline and 1 year||||units on a scale||Standard Deviation|Mean
1330693|NCT02093234|Secondary|Change in Hemoglobin A1C|Change in HbA1c after 1 year from baseline|Baseline and 1 year||||Percentage of total hemoglobin||Standard Error|Mean
1330694|NCT02093234|Secondary|Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument|"Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24.~Low distress < 12 : moderate / high distress > or = 12."|Baseline and 1 year||||units on a scale||Standard Error|Mean
1330695|NCT02093234|Primary|Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1|The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.|baseline and 1 year|Sample size estimates were based on the study hypotheses and the associated primary endpoint. Dropouts were analyzed using intention to treat methodology.|||incomplete behaviors/goals||Standard Error|Mean
1330696|NCT02093221|Secondary|Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime||Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||mmol/L||Standard Deviation|Mean
1330697|NCT02093221|Secondary|Change From Baseline for Mean Daily Insulin Dose Requirements||Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||U/kg/day||Standard Deviation|Mean
1330698|NCT02093221|Secondary|Number of Overall Severe Hypoglycemic Episodes|Severe hypoglycemia defined according the ADA Workgroup on Hypoglycemia definition, as follows: An event requiring assistance of another person to actively administer carbohydrate, glucagons, or other resuscitative actions.|104 weeks|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||Participants|||Count of Participants
1330699|NCT02093221|Secondary|Change From Baseline for HbA1c Levels||Weeks 14, 27, 39, 52, 69, 87, and 104|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||percentage of change from baseline||Standard Deviation|Mean
1330700|NCT02093221|Secondary|Change From Baseline for MMTT Stimulated C-peptide 2h AUC||Weeks 14, 27, 39, 69, 87, and 104|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||min*nmol/L||Standard Deviation|Mean
1330701|NCT02093221|Primary|Change From Baseline in Mixed Meal Tolerance Test (MMTMT) Stimulated C-peptide 2 Hour Area Under the Concentration-time Curve (AUC)|"C-peptide concentration during MMTT with high protein energy drink. Dose for time frame refers to intake of high protein energy drink."|Week 52||||min*nmol/L||Standard Deviation|Mean
1330702|NCT02093026|Secondary|Time Since Last Treatment Course|Time since last treatment course = The last day of the last dose of rituximab to date of last contact. Date of last contact is the last available date of efficacy, complete medication start date, laboratory, adverse event assessments, early withdrawal visit, date of last contact, or date of death.|Baseline up to 10 years|ITT Population. Here, number of participants analyzed = participants who entered into safety follow-up.|||years||Standard Deviation|Mean
1330703|NCT02093026|Secondary|Percentage of Participants Who Discontinued Treatment Due to Insufficient Response||First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)|Safety Population. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
1330704|NCT02093026|Secondary|Change From Baseline in Total Rheumatoid Factors (RF) at 24 Weeks Following Each Course||24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|The data for this outcome measure was not analyzed as this outcome was removed per changes in the planned analysis. Per changes in the planned analysis, only key efficacy parameters were analyzed as the long-term efficacy of rituximab is well established.||||||
1330705|NCT02093026|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
1330706|NCT02093026|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*Patient's Global Assessment of Disease Activity. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to less than or equal to (≤) 5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
1330707|NCT02093026|Secondary|Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hour]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*square root (sqrt)(TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR <= 3.2 implied low disease activity (LDA) and DAS28-ESR <2.6 = clinical remission.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
1330708|NCT02093026|Secondary|American College of Rheumatology Index of Improvement (ACRn) Response|The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient’s assessment of disease activity; patient’s global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value [either CRP or ESR]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
1330709|NCT02093026|Secondary|Percentage of Participants With ACR50 and ACR70 Response|A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
1330710|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Seventh Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after seventh course of rituximab (median duration of 406.7 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1330711|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Sixth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after sixth course of rituximab (median duration of 354.4 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1330735|NCT02092649|Primary|Change in Resting Metabolic Rate From Baseline|Percent change in resting metabolic rate|Baseline, 6 weeks, 12 weeks||||percent change||Standard Deviation|Mean
1330736|NCT02092610|Secondary|Implant Survival||60 months|"These data are already presented in the Longterm Survival of Implant section."||||||
1331766|NCT02071849|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
1330712|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Fifth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after fifth course of rituximab (median duration of 297.3 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1330713|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Fourth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after fourth course of rituximab (median duration of 232 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1330714|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Third Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after third course of rituximab (median duration of 162.9 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1330715|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Second Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after second course of rituximab (median duration of 90.9 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1330716|NCT02093026|Primary|Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course|A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after first course of rituximab (up to approximately 26 weeks)|Intent to treat (ITT) Population included all participants who received any part of an infusion of study medication under Study WA16855. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
1330717|NCT02092961|Other Pre-specified|DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1330762|NCT02092220|Other Pre-specified|Mean Daily Basal Insulin Dose|Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).|Day 1, Days 2 to 11, each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
1330763|NCT02092220|Other Pre-specified|Number of Unscheduled Infusion Set Replacements||11 days|All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm.|||Infusion Set Relacements|||Number
1330718|NCT02092961|Other Pre-specified|OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS erosions score was based on 25 joints and ranged from 0 to 250 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
1330719|NCT02092961|Other Pre-specified|Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|Joint space narrowing score was based on 20 joints, scored from MRI images and ranged from 0 to 80 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, JSN = joint space narrowing, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
1330720|NCT02092961|Other Pre-specified|OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS osteitis score was based on 25 joints, scored from MRI images, and ranged from 0 to 75 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
1330721|NCT02092961|Primary|OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
1330722|NCT02092857|Primary|Number of Antigen-presenting B Cells||10 weeks||||percentage of CD20+ B cells|||Number
1330723|NCT02092662|Secondary|Handwriting Off-paper Time.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The time the pen is on air is measured. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...|||||||
1330724|NCT02092662|Secondary|Handwriting Pressure.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...|||||||
1330725|NCT02092662|Secondary|% Maximum Voluntary Contraction.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.|||||||
1330726|NCT02092662|Primary|Muscle Onset Time.|Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.|the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1||||seconds||Standard Deviation|Mean
1330727|NCT02092662|Secondary|Handwriting Velocity|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.|T1 at the beginning of the hospital stay and follow up at T2 one month later.|||||||
1330728|NCT02092662|Secondary|Muscle Co-activation Index.|Assessed by surface electromyography device. Indicate for the level by which muscles contract at the same time and amplitude. It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|||||||
1330729|NCT02092662|Primary|Fugl-Meyer Assessment.|zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.||||units on a scale||Standard Deviation|Mean
1330730|NCT02092649|Secondary|Change in Fasted Blood Triglyceride Concentration From Baseline||Baseline, 12 weeks||||percent change||Standard Deviation|Mean
1330731|NCT02092649|Secondary|Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days||Baseline, 6 weeks, 12 weeks||||percent variability||Standard Deviation|Mean
1330737|NCT02092610|Secondary|Soft Tissue Status|"To evaluate the status of the soft tissue at the implant site.~The scale Holgers Index 4 is designed to capture signs and symptoms of inflammation or infection at the site of implantation. The scale should be completed at the visit.~The scale consists of the following steps:~0. No irritation. Epidermal debris removed, if present~Slight redness. Local temporary treatment, if needed~Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated~Reddish and moist; sometimes granulations tissue, revision surgery is indicated~Removal of the abutment/implant necessary due to infection R. Removal of abutment/implant for reasons not related to skin problems"|At the single 60 months visit|Five year follow up population|||% of participants|||Number
1330738|NCT02092610|Secondary|Longterm Survival of Implant|"To compare the long term survival of the novel implant and abutment and the standard implant and abutment in the Baha system.~All patients will be asked if they have experienced any implant osseointegration problems which would have made the implant to get loose. The time from implant implantation until implant loss or removal will be collected. In case of implant removal, reason for removal shall be recorded."|At the single 60 months visit|Survival population, all patients in the ITT population in the original study CAG5173 (all randomized patients who get surgery).|||% survival rate of implants|||Number
1330739|NCT02092610|Primary|Implant Stability|To show superiority of the novel implant compared to standard implants regarding stability of the implants measured as ISQ values at the abutment level. The ISQ value ranges from 1 to 100, the higher ISQ value, the higher the implant stabilty. Mean AUC 0-60 months ISQ represents a weighted average of the implant stability during the 60 months from start of the CAG5173 study to the measurement in this study CBAS5562. The ISQ 5 years value represents the single ISQ measurment at 5 years.|At the single 60 months visit|The 5 year follow up population consisted of the patients in the ITT population (all randomized subjects who received surgery) in the CAG5173 study who attended this study which was a 5-year follow up visit.|||ISQ scores||Standard Deviation|Mean
1330740|NCT02092441|Other Pre-specified|Satisfaction Measured on a 5-point Likert Scale|"Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 (completely unsatisfied) to 5 (completely satisfied)"|10 minutes post intervention||||5 point Likert Scale||Inter-Quartile Range|Median
1330741|NCT02092441|Secondary|Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention|"Scale ranges from 0 (no pain) to 10 (worst pain imaginable)"|10 minutes post intervention||||VNRS||Inter-Quartile Range|Median
1330742|NCT02092441|Primary|Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention|"Primary outcome is nausea and vomiting measured on a scale from 0 (no nausea) to 10 (worst nausea imaginable) Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention."|10 minutes post intervention||||VNRS||Inter-Quartile Range|Median
1330743|NCT02092415|Primary|Muscle Perfusion|Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.|baseline and 1 min post occlusion||||IU/s||Standard Error|Mean
1330744|NCT02092389|Secondary|Correlation Between fC and Workability Determined by WPAI:UC Questionnaire|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
1330745|NCT02092389|Secondary|Correlation Between fC and Patient's QoL Determined by the sIBDQ|fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The sIBDQ is a disease-specific health-related QoL questionnaire, able to detect and define meaningful clinical changes in IBD patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
1330746|NCT02092389|Secondary|Correlation Between fC and Disease Activity Determined by Partial Mayo Score|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
1330747|NCT02092389|Secondary|Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score|A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
1330748|NCT02092389|Secondary|Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ)|The sIBDQ is a disease-specific health-related quality of life (QoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). Increased scores correspond to an improvement in QoL.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
1330764|NCT02092220|Other Pre-specified|Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM||11 days|All randomized participants who completed both periods.|||percentage of possible values||Standard Deviation|Mean
1330765|NCT02092220|Secondary|Number of Participants With Skin Rash||11 days of each period|All randomized participants who completed both periods of the study.|||Participants|||Count of Participants
1330749|NCT02092389|Secondary|Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire|The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-UC is calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
1330750|NCT02092389|Primary|Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided.|Month 12|Enrolled participants with Month 12 data at the time of study termination|||percentage of participants|||Number
1330751|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA <LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.|||Percentage of participants||95% Confidence Interval|Number
1330752|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA <LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.|||Percentage of participants||95% Confidence Interval|Number
1330753|NCT02092350|Primary|Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 12|The APaT population includes all enrolled participants who received at least one dose of study drug.|||Participants|||Number
1330754|NCT02092350|Primary|Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 14|The All Participants as Treated (APaT) population includes all enrolled participants who received at least one dose of study drug.|||Participants|||Number
1330755|NCT02092350|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)|The modified Full Analysis set (mFAS) includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.|||Percentage of participants||95% Confidence Interval|Number
1330756|NCT02092311|Other Pre-specified|Post-varicocelectomy Testicular Atrophy|development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery|6months||||Participants|||Number
1330757|NCT02092311|Secondary|Post-varicocelectomy Hydrocele|Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery|6months||||Participants|||Number
1330758|NCT02092311|Primary|Recurrent Varicocele|post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery|6 months||||participants|||Number
1330759|NCT02092285|Primary|Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54|The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician’s global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.|Baseline (Week 0), Week 6, Week 30, Week 54|The analysis population for the evaluation of efficacy during the maintenance period was the Full Analysis Set (FAS205) consisting of participants who received at least 1 dose of golimumab.|||Percentage of Participants||95% Confidence Interval|Number
1330760|NCT02092220|Other Pre-specified|CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads|This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM.|11 days|All randomized participants who completed both periods.|||percent difference||Standard Deviation|Mean
1330761|NCT02092220|Other Pre-specified|Mean Daily Bolus Insulin Dose|Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).|Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
1330766|NCT02092220|Secondary|Change From Baseline in Hemoglobin|The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.|Baseline and Day 12 of each period|All randomized participants who completed both periods of the study.|||grams/deciliter (mg/dL)||Standard Deviation|Mean
1330767|NCT02092220|Secondary|Change From Baseline in Body Weight|The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.|Baseline and Day 12 of each period|All participants who completed both periods of the study.|||kilograms||Standard Deviation|Mean
1330768|NCT02092220|Secondary|Mean Nausea Index Score Using a Visual Analog Scale (VAS)|Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.|Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.|||cm||Standard Deviation|Mean
1330769|NCT02092220|Secondary|Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly|Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.|11 days|All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only|||percentage of time||Standard Deviation|Mean
1330770|NCT02092220|Secondary|Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm||Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
1330771|NCT02092220|Secondary|Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm|Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).|Day 1, Days 2 to 11, Days 1 to 11 of each period|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||µg/kg/day||Standard Deviation|Mean
1330772|NCT02092220|Secondary|Insulin Total Daily Dose|Insulin total daily dose is reported in units per kilogram per day (U/kg/day).|Day 1, Days 1 to 11, Days 2 to 11 of each period|All participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
1330773|NCT02092220|Secondary|Total Grams of Carbohydrate Taken for Hypoglycemia|"The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged.~The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported."|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.|||grams of carbohydrate per day||Standard Deviation|Mean
1330774|NCT02092220|Secondary|Number of Reported Carbohydrate Interventions for Hypoglycemia|The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.|||interventions per day||Standard Deviation|Mean
1330775|NCT02092220|Secondary|Number of Episodes of Symptomatic Hypoglycemia|The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.|||episodes per day||Standard Deviation|Mean
1330776|NCT02092220|Secondary|Number of Participants With Severe Hypoglycemic Events|A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.|11 days of each period|All participants who completed both periods of the study.|||Participants|||Count of Participants
1330777|NCT02092220|Secondary|Anti-Insulin and Anti-Glucagon Antibodies on Day 12||Day 12 of each period|No data was collected for Anti-Insulin and Anti-Glucagon Antibodies.||||||
1330778|NCT02092220|Secondary|1,5-anhydroglucitol on Day 12||Day 12 of each period|No data was collected for 1,5-anhydroglucitol.||||||
1330779|NCT02092220|Secondary|Glycated Albumin on Day 12||Day 12 of each period|No data was collected for Glycated Albumin.||||||
1330780|NCT02092220|Secondary|Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care|The percentage of days that participants reported the CGM device was being worn and working properly is reported.|Days 1-11 of each period|All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm.|||percentage of days|||Number
1330781|NCT02092220|Secondary|Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-11||||hypoglycemic events||Standard Deviation|Mean
1330782|NCT02092220|Secondary|Percentage of Participants With Mean CGMG < 154 mg/dl|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.|Day 1, Days 2 to11, Days 1 to11 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
1330783|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:~< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1330784|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:~< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Days 1 to 11 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1330785|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Day 1|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:~< 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Day 1 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1330786|NCT02092220|Secondary|Mean CGMG Values|Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.|Day 1 and Days 1 to 11 in each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
1330787|NCT02092220|Primary|Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11|Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
1330788|NCT02092220|Primary|Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11|Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.|||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
1330789|NCT02092168|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration|AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration|Day 1 and Day 7||||ng.h/mL||Standard Deviation|Mean
1330790|NCT02092168|Primary|Tmax - Time to Reach Cmax|Tmax - Time to reach maximum plasma concentration of BIA 9-1067|Day 1 and Day 7||||hours||Full Range|Median
1330791|NCT02092168|Primary|Cmax - Maximum Plasma Concentration|Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067|Day 1 and Day 7||||ng/mL||Standard Deviation|Mean
1330792|NCT02092116|Secondary|Part B: Level of HIV-1 Transcription.|At day 105, 112 and 119 patients receive romidepsin and 4 hours after each administration HIV transcription is measured as unspliced HIV-1 RNA.|Day 105, 112 and 119|All available samples were included in this analysis; 3 withdrew consent and 2 (3 for day 119) did not have analyzable samples.|||copies/10^6 CD4+ T cells||Standard Deviation|Mean
1330793|NCT02092116|Secondary|Part B: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Safety and tolerability evaluation of romidepsin and Vacc-4x in combination with GM-CSF as measured by adverse events (AE) and serious adverse events (SAE).|287 days||||participants|||Number
1330794|NCT02092116|Secondary|Part A: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus. Estimates of Change From Baseline of the Size of the Latent HIV-1 Reservoir in CD4+ Cells.|"Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.~Total HIV-1 DNA was measured at Day 84"|Day 56/84|1 patient did not have a quantifiable load of total HIV-1 DNA at Day 84 and 2 patients diod not have a quantifiable load of replication competent provirus at day 56.|||copies/10^6 CD4+ T cells||Standard Deviation|Mean
1330795|NCT02092116|Primary|Part B: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus.|"Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.~Blood samples were obtained at Day 0, Day 105 and Day 161."|Day 161/175|"4 patients were excluded; 3 discontinued and 1 sample was not eligible for analysis.~Sensitivity of the qVOA was low; 2/3 of all measurements were under the limit of detection. 6 subjects had quantifiable viral outgrowth on baseline, 8 had viral outgrowth after immunization (Day 105) and 6 had viral outgrowth after romidepsin (Day 161)."|||Estimated % change from baseline||95% Confidence Interval|Mean
1330796|NCT02092116|Primary|Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Safety and tolerability evaluation as measured by adverse events (AE) and serious adverse events (SAE).|3 weeks||||participants|||Number
1330797|NCT02091986|Secondary|Number of Patients With an Asthma Exacerbation During Study|Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.|Week 0 (baseline) up to Week 12|"All patients randomized who:~received at least one dose of study medication;~data collected after randomisation. Patients accounted for according to the treatment they actually received."|||Partcicipants|||Number
1330798|NCT02091986|Secondary|Change From Baseline to Study Period Average in Overall PAQLQ Score|"Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).~The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1–7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated."|Week 0 (baseline), week 4, week 8, week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||unit on a scale||95% Confidence Interval|Least Squares Mean
1330810|NCT02091986|Primary|Change From Baseline to Week 12 in 1h Post-dose FEV1|1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint.~Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
1330799|NCT02091986|Secondary|Change From Baseline to End of Study Average in Total Daily Reliever Medication|End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Number of reliever medication use||Standard Deviation|Mean
1330800|NCT02091986|Secondary|Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms|End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Percentage of nighttime awakenings||Standard Deviation|Mean
1330801|NCT02091986|Secondary|Change From Baseline to End of Study Average in Total Asthma Symptoms|"End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).~Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma~= Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated~= Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep~= Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep~Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6)."|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||units on a scale||Standard Deviation|Mean
1330802|NCT02091986|Secondary|Change From Baseline to Week 12 in 15 Min Post-dose FEV1|15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
1330803|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FVC|Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
1330804|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FEF25-75|Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters per minute||95% Confidence Interval|Least Squares Mean
1330805|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose PEF|Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters per minute||95% Confidence Interval|Least Squares Mean
1330806|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FEV1|Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
1330807|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose FVC|1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
1330808|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose FEF25-75|1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters per second||95% Confidence Interval|Least Squares Mean
1330809|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose PEF|1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint.~Patients accounted for according to the treatment to which they were randomized."|||Liters per minute||95% Confidence Interval|Least Squares Mean
1330811|NCT02091960|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a patient administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption or discontinuation of study medication, or was clinically significant in the opinion of the investigator.~An AE was defined as serious if it resulted in any of the following outcomes:~Death~Was life-threatening~Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions~Congenital anomaly, or birth defect~Inpatient hospitalization or prolongation of hospitalization~Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out."|From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever was first; median duration of treatment was 70 days, and the maximum was 660 days.|The safety analysis set included all participants who received at least 1 or partial dose of study drug.|||Participants|||Count of Participants
1330812|NCT02091960|Secondary|Time to Response|Time to response was defined as the time from the first date of enzalutamide treatment to initial CR or PR and was calculated for participants with a CR or PR.|From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set with a best overall response of CR or PR|||days||95% Confidence Interval|Median
1330813|NCT02091960|Secondary|Duration of Response|Duration of response was defined as the time from the date of first documentation of response (CR or PR) until the date of disease progression per RECIST 1.1. Participants who initiated another anti-tumor therapy before documented PD, progressed after missing two or more consecutive radiological assessments or who died before disease progression were censored at the date of the last radiological assessment showing no progression.|Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set participants with a best overall response of CR or PR|||days||95% Confidence Interval|Median
1330814|NCT02091960|Secondary|Time to Progression|Time to progression was defined as the time from the first date of enzalutamide treatment until the date of disease progression per RECIST 1.1. Participants who initiated another anti-tumor therapy before documented PD, who progressed after missing two or more consecutive radiological assessments or who died before disease progression were censored at the date of the last radiological assessment showing no progression.|From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy analysis set|||days||Full Range|Median
1330815|NCT02091960|Secondary|Progression-free Survival|"Progression-free survival was defined as the time from the date of first dose of enzalutamide until the date of disease progression per RECIST 1.1, or death from any cause on study, whichever occurred first. Participants who initiated another antitumor therapy before documented progressive disease (PD) or death, or who progressed or died after missing 2 or more consecutive radiological assessments were censored at the date of the last radiological assessment showing no progression.~Progressive disease was defined as a ≥ 20% increase in the size of target lesions and at least a 5 mm increase in size of target lesions from smallest size on study, or unequivocal progression of non-target lesions, or any new lesions."|From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set|||days||95% Confidence Interval|Median
1330816|NCT02091960|Secondary|Best Overall Response Rate|"Best overall response was the best response across all time points, based on investigator assessments.~Best overall response rate was defined as the percentage of evaluable participants with a best objective response of confirmed complete response (CR) or partial response (PR) at any time during the study per RECIST 1.1.~Complete response was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all < 10 mm in short axis.~Partial response was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions with persistence of non-target lesions and no new lesions.~PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date of scan that PR or CR was first observed."|Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set|||percentage of participants||95% Confidence Interval|Number
1330817|NCT02091960|Secondary|Overall Response Rate at Week 24|"Overall response rate was defined as the percentage of evaluable participants with a best objective response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1.~Complete response was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all < 10 mm in short axis.~Partial response was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions with persistence of non-target lesions and no new lesions.~PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date of scan that PR or CR was first observed."|24 weeks|Efficacy evaluable set|||percentage of participants||95% Confidence Interval|Number
1330827|NCT02091856|Primary|Beck Depression Inventory-II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents the post-intervention assessment."|Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
1330828|NCT02091778|Primary|Change in Peri-wound Skin|Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin|12 weeks|number of patients with healthy/intact peri-wound skin that increased from baseline to final visit. (From 6 to 14)|||participants|||Number
1330829|NCT02091752|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores||Baseline, Day 1, Week 8, Week 12, Week 16, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
1330818|NCT02091960|Primary|Clinical Benefit Rate (CBR)|"Clinical benefit rate was defined as the percentage of evaluable participants with best objective response of confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or prolonged stable disease (≥ 24 weeks).~Complete response (CR) was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all < 10 mm in short axis.~Partial response (PR) was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions, with persistence of non-target lesions and no new lesions.~Stable disease (SD) was defined as < 30% decrease and < 20% increase in the size of target lesions, persistence of non-target lesions, and no new lesions.~PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date that PR or CR was first observed. SD required confirmation with equivalent or improved assessment no less than 8 weeks after enrollment."|Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days.|The efficacy evaluable set (EES) includes all enrolled participants who had centrally assessed androgen receptor positive (AR+; defined as ≥ 10% of tumor cells with nuclear expression), received at least one dose of study drug, and had at least one available post baseline tumor assessment.|||percentage of participants||95% Confidence Interval|Number
1330819|NCT02091869|Other Pre-specified|Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans|We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.|Six months|Mobile phone usage was not assessed in the paper asthma action plan group.|||times per week||Full Range|Median
1330820|NCT02091869|Other Pre-specified|Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans|We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.|Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. Three participants did not use the mobile app per protocol.|||days per week||Full Range|Median
1330821|NCT02091869|Secondary|Change in Asthma Self-Efficacy Scores|"The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from “not at all sure” (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to “completely sure” (5 points). Total score range from 14-70. The attack prevention scale range from 6-30 and attack management range from 8-40. The higher score represent a greater degree of self-efficacy. The Cronbach’s α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention)."|Baseline and Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol.|||units on a scale||Full Range|Median
1330822|NCT02091869|Primary|Change in Asthma Control Test Scores|"The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5)."|Baseline and Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. The biostatistician was not be involved in testing or intervention procedures.|||units on a scale||Full Range|Median
1330823|NCT02091856|Primary|Beck Depression Inventory II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents the measure of depression at 6 month after the intervention."|Absolute values (average score) of BDI-II at 37 weeks (follow-up)|Only 10 participants from the C-CBT and 9 participants from the R-CBT completed the follow-up assessment questionnaires. Participants from the Wailt-List Control Group were lost at follow-up.|||units on a scale||Standard Deviation|Mean
1330824|NCT02091856|Secondary|Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR)|"The Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR) was designed to measure participant’s level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents a secondary outcome measure for depression taken immediately after the intervention."|Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
1330825|NCT02091856|Secondary|Quality of Life Inventory (QOLI)|"The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality.~This represents the post-intervention assessment."|Absolute values (average score) of QOLI at 11 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
1330826|NCT02091856|Secondary|Beck Anxiety Inventory (BAI)|"The Beck Anxiety Inventory (BAI) was designed to measure participant’s level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.~This represent the post-intervention assessment."|Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
1330837|NCT02091739|Secondary|MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12|The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.|Week 1, 2, 8, and 12|The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||units on a scale||Standard Error|Least Squares Mean
1330838|NCT02091739|Secondary|MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12|uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.|Baseline, Week 8 and 12|Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||g/min||Standard Error|Least Squares Mean
1330839|NCT02091739|Primary|MP: Participant's Global Impression of Change Scale (GICS) at Week 4|The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.|Week 4|The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||units on a scale||Standard Error|Least Squares Mean
1330840|NCT02091739|Primary|MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4|uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.|Baseline and Week 4|Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||gram per minute (g/min)||Standard Error|Least Squares Mean
1330841|NCT02091726|Secondary|Participant Fully Satisfied and Would Recommend to Friends and Family|Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?|4 weeks|104 men came for their 4-week followup, but 1 man did not complete the satisfaction questions.|||participants|||Number
1330842|NCT02091726|Secondary|Cosmetic Result Excellent|Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line|4 weeks|104 men came for their 4-week followup but the doctor(s) failed to note the cosmetic result in 2 men.|||participants|||Number
1330843|NCT02091726|Secondary|Wound Separation|Wound separation caused by adhesive failure (minor --requires no treatment)|4 weeks|Wound dehiscence < 2 cm. None required treatment. There were no participants with wound dehiscence > 2 cm.|||participants|||Number
1330844|NCT02091726|Secondary|Completely Healed at 4 Weeks|Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present|4 weeks||||participants|||Number
1330845|NCT02091726|Primary|Time for Procedure|Intraoperative time, total|1 hour||||Min||Inter-Quartile Range|Median
1330846|NCT02091466|Primary|Maternal Hypothermia|Hypothermia was measured by means of tympanic temperatures.|60 minutes|Sample size was calculated to be 20 subjects in each group to ensure that a difference of 0.5ºC at 60 minutes could be detected at significance level of 5% with a statistical power of 90%, assuming the standard deviation of differences to be 0.5ºC, considering a temperature below 36.0ºC could be considered hypothermia|||Centigrades||Standard Deviation|Mean
1330847|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
1330848|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
1330849|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
1330850|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
1330851|NCT02091414|Secondary|Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
1330852|NCT02091414|Secondary|Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1330853|NCT02091414|Secondary|Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
1330854|NCT02091414|Secondary|Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
1330855|NCT02091414|Primary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week|Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.|Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1330856|NCT02091375|Secondary|Caregiver Global Impression Of Change (CGIC)|The CGIC was used to assess the participant’s overall condition on a 7-point scale using the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse” (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant’s overall condition as a memory aid for the CGIC questionnaire at subsequent visits.|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
1330857|NCT02091375|Secondary|Change From Baseline In Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score|The Vineland-II scores (standard scores and adaptive levels for each adaptive behavior domain, the adaptive behavior composite, and the maladaptive behavior index score and level) were assessed by the participant’s caregiver. Scores were analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6 to 12 years, and 13 to 18 years) as covariates and treatment group as a fixed factor. Higher scores represent greater levels of functioning except for the maladaptive behavior index, for which a negative change from baseline represents an improvement in condition.|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
1330858|NCT02091375|Secondary|Change From Baseline In Quality Of Life In Childhood Epilepsy (QOLCE) Score|The QOLCE questionnaire was completed by the parent or caregiver of participants aged 4 years and above. The change from baseline in the overall quality of life score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. Zero represents the lowest or poorest category and 100 represents the highest level of functioning. The overall quality of life score was calculated by taking the mean of the subscale scores.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
1330859|NCT02091375|Secondary|Change From Baseline In Epworth Sleepiness Scale (ESS) Score|The ESS questionnaire was completed by the participant’s caregiver. The change from baseline in the ESS score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6- to 2 years and 13 to 18 years) as covariates and treatment group as a fixed factor. The total score was the sum of the 8 item-scores and ranged from 0 to 24. A higher total score represents greater levels of daytime sleepiness.|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
1330860|NCT02091375|Secondary|Change From Baseline In Sleep Disruption 0 To 10 Numerical Rating Scale (0 to 10 NRS) Score|The sleep disruption 0 to 10 NRS questionnaire was completed by the participant’s caregiver. The caregiver was asked ‘On a scale of ‘0 to 10’, please indicate the number that best describes your child’s sleep disruption in the last week.’ The markers ranged from 0 = ‘slept extremely well’ to 10 = ‘unable to sleep at all’. The change from baseline in the sleep disruption 0 to 10 numerical rating scale score was analyzed using an analysis of covariance (ANCOVA) model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. A negative change from baseline represents an improvement in sleep. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant’s last evaluation was performed.|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
1330861|NCT02091375|Secondary|Number Of Participants With Inpatient Hospitalizations Due To Epilepsy|Inpatient hospitalizations due to epilepsy were recorded by the participant or caregiver and through the serious adverse events (SAE) reporting process.|Baseline to Safety Follow-up (Day 137)|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||participants|||Number
1330862|NCT02091375|Secondary|Number Of Participants Using Rescue Medication|The use of rescue medication was recorded by the participant or caregiver using a paper diary.|Baseline to EOT (Day 99) or ET|Safety Analysis Set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the actual treatment they received.|||Participants|||Count of Participants
1330863|NCT02091375|Secondary|Caregiver Global Impression Of Change In Seizure Duration (CGICSD)|Seizure duration was assessed qualitatively using the CGICSD. Caregivers were asked “Since the patient started treatment, please assess the average duration of the patient’s seizures (comparing their condition now to their condition before treatment)”; responses included decrease, no change, or increase in average duration. For each seizure type, only participants with at least 1 seizure for the corresponding seizure type, reported at any time during the study, were included.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
1331171|NCT02082184|Secondary|Frequency of Episodes <70 mg/dL and <55 mg/dL|Difference in frequency of episodes <70 mg/dL and <55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208||||number of episodes per day||Standard Deviation|Mean
1330864|NCT02091375|Secondary|Percentage Change From Baseline In Non-Convulsive Seizure Frequency During The Treatment Period|Non-convulsive seizures (myoclonic, partial, or absence) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Only participants with non-convulsive seizures during the baseline period were included. Negative percentages show an improvement from baseline.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||percent change||Inter-Quartile Range|Median
1330865|NCT02091375|Secondary|Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period|Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
1330866|NCT02091375|Secondary|Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period|Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
1330867|NCT02091375|Primary|Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period|Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) * 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) * 28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline.|Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||percent change||Inter-Quartile Range|Median
1330868|NCT02091362|Secondary|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021|Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.|All randomized participants who received at least 1 one dose of study drug and had at least one measureable drug concentration.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1330869|NCT02091362|Secondary|Population Pharmacokinetics: Apparent Clearance of LY2409021|Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1330870|NCT02091362|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
1330871|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)|Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
1330872|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures|Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
1330873|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate|Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||beats/minute||95% Confidence Interval|Least Squares Mean
1330989|NCT02085785|Primary|Number of Individuals That Were Randomized of Those Contacted (Feasibility)|Specific components include yield by method, recruitment rate, refusal rates and reasons|During recruitment (expected duration of 12-15 months)|313 individuals were assessed for this outcome measure. Note that the number analyzed are those that we contacted via a mailing or who contacted the study after seeing a study flyer.|||participants|||Number
1330874|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure|Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
1330875|NCT02091362|Primary|Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure|Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
1330876|NCT02091206|Secondary|Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations|Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22).|Predose on Days 1 and 22|Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.|||percent change|||Number
1330877|NCT02091206|Secondary|Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22|AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation.|Predose and 2-6 hours postdose on Days 1 and 22|Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.|||hours * nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
1330878|NCT02091206|Primary|Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented.~A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module."|Baseline (Day 1) through Safety follow-up visit (Day 60)|Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.|||Participants|||Count of Participants
1330879|NCT02090894|Secondary|Relative Level of IGF-1 mRNA in the Skin|IGF-1 mRNA per 100,000 beta-2 microglobulin mRNA|untreated and LaserGenesis treated, three months after treatment|untreated and laser treated biopsies were taken from each subject|||relative mRNA||Standard Error|Mean
1330880|NCT02090894|Primary|Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers|Number of double positive cells per 1000 total basal layer keratinocytes|untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB|untreated and laser treated biopsies were taken from each subject|||positive cells/1000 basal layer cells||Standard Deviation|Mean
1330881|NCT02090855|Secondary|Specificity Percentage of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Percentage of Specificity|||Number
1330882|NCT02090855|Primary|Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Percent of Sensitivity|||Number
1330883|NCT02090855|Secondary|Number of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Number of Blinded Image Intrepretations|||Number
1330884|NCT02090855|Primary|The Number of Abnormal Blinded Visual PET Image Interpretations.|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Number of Blinded Image Interpretations|||Number
1330885|NCT02090777|Primary|Glaucoma Medication Adherence|Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage. The average of the participants percentage of time they adhered to using the medication will be reported.|6 Months||||percentage of adherence time||Standard Deviation|Mean
1330990|NCT02085720|Secondary|Sleep and Health Questionnaire Result||1 year||||% of participants|||Number
1330991|NCT02085720|Secondary|AHI Result||1 year||||% of participants|||Number
1330886|NCT02090764|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.~Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.~The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain."|Visit 3 (Day 6-7)|"Intent-to-treat clinical (ITTC) population was defined as all randomized patients.~The % of clinical success for the treatment comparison were calculated excluding the unable to determine: OZN (112/203), PLB (78/199)"|||percentage of Participants|||Number
1330887|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS|For the EQ-VAS, the participant was instructed to draw a line on a 20-cm vertical scale at the point that best describes his or her own health, where 0 represents the “worst imaginable health state” and 100 represents the “best imaginable health state.”|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330888|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330889|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330890|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330891|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330892|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility|EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has “no problems” (1), “some problems” (2), or “severe problems” (3). A negative change from Baseline indicates improvement.|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330893|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330894|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or early termination (ET)|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1330895|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
1330896|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
1330897|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
1330898|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
1330899|NCT02090413|Secondary|Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48|Participant-reported flushing events (which include redness, warmth, tingling, and/or itching of the skin) during Weeks 13 to 48 of treatment were recorded in the CRF.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
1330900|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). For participants with more than 1 flushing event during a visit interval, the average duration for the visit interval was used.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||hours||Standard Deviation|Mean
1330901|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MGFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 12|Although designated as a secondary endpoint, the duration of flushing events based on MGFSS could not be calculated because specific flushing events with start and end times was not captured in the MGFSS.||||||
1330902|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||units on a scale||Standard Deviation|Mean
1330903|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||units on a scale||Standard Deviation|Mean
1330904|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
1330905|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||percentage of participants|||Number
1330906|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||units on a scale||Standard Deviation|Mean
1330907|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||units on a scale||Standard Deviation|Mean
1330908|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
1330909|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the first 4 weeks treatment, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants evaluable at given time point.|||percentage of participants|||Number
1330910|NCT02090088|Secondary|Number of Participants With Adverse Events||Throughout pregnancy and for up to 6 weeks after delivery|All enrolled participants|||participants|||Number
1330911|NCT02090088|Secondary|Number of Infants With Adverse Events|In the first year of life, the incidence of all serious adverse events, as well as of nevi (birthmarks) and angiomata (benign tumors with blood vessels or lymph vessels), among infants whose mothers received Nplate® therapy at any time during the pregnancy.|12 months from birth|Children born to enrolled participants during the study|||infants|||Number
1330912|NCT02090088|Secondary|Number of Children Born With Intrauterine Growth Restriction|Number of children born with intrauterine growth restriction (weight, length or head circumference less than tenth percentile for sex and gestational age) among mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study|||children|||Number
1330913|NCT02090088|Secondary|Number of Children With Preterm Birth or Low Birth Weight|Number of children with preterm birth (<37 weeks gestation) or low birth weight (<2,500 grams) among children born to mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study|||children|||Number
1330992|NCT02085720|Secondary|CPAP Compliance Among Chinese Elderly|Elderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).|1 year||||hours||Standard Deviation|Mean
1330916|NCT02090088|Secondary|Number of Children Born With Any 3 or More Minor Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A minor structural defect is defined as a defect which occurs in less than 4% of the population but which has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes).|At birth|Children born to enrolled participants during the study|||children|||Number
1330917|NCT02090088|Primary|Number of Children Born With Major Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (eg, a cleft lip), require surgery, or are life-limiting).|At birth|Children born to enrolled participants during the study|||children|||Number
1330918|NCT02089737|Secondary|Overall Survival|Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.|Up to Week 42 or death (whichever occurred first)|All participants that received panitumumab monotherapy as a third-line or later therapy.|||weeks||95% Confidence Interval|Median
1330919|NCT02089737|Secondary|Progression-free Survival|Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Up to Week 42 or death (whichever occurred first)|Participants who were included in the efficacy analysis set and received panitumumab monotherapy as a third-line or later therapy.|||Months||95% Confidence Interval|Median
1330920|NCT02089737|Primary|Number of Participants With Adverse Drug Reactions|The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.|Baseline through Week 42|Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing.|||Participants|||Number
1330921|NCT02089347|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine|Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling >100 mm. Grade 3 systemic reactions: Fever, >39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of Participants|||Number
1330922|NCT02089347|Secondary|Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine|Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration was assessed in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1330923|NCT02089347|Secondary|Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).~Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population|||Percentage of Participants|||Number
1330924|NCT02089347|Secondary|Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine|Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration were assessed in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1330925|NCT02089347|Secondary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
1330926|NCT02089347|Secondary|Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Pre-vaccination (Day 0)|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
1330941|NCT02087995|Primary|The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.|The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels > 80 mg/dL or within 20 mg/dL at the reference glucose levels < 80 mg/dL.|7-day wear period|For the demographic and other baseline characteristic information, data from all 51 enrolled subjects was summarized.|||Units analyzed% matched pairs w/i %20/20|||Number
1330927|NCT02089347|Primary|Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).~Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population|||Percentage of Participants|||Number
1330928|NCT02089347|Primary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
1330929|NCT02089347|Primary|Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT|"Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Post-vaccination booster response was determined in the per-protocol population|||Percentage of Participants|||Number
1330930|NCT02089191|Secondary|Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.|Hour 12|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||percent distortion per second||Standard Deviation|Mean
1330931|NCT02089191|Primary|Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.|Day 1, Hour 12, each period|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||seconds||Standard Deviation|Mean
1330932|NCT02089113|Primary|Absence of Cells in Anterior Chamber of the Study Eye||Day 14||||percentage of participants|||Number
1330933|NCT02088957|Secondary|Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration|This variable was not analyzed and no results are available.||||||
1330934|NCT02088957|Secondary|Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration||Between 15 minutes to 12 hours after first acute iv administration|This variable was not analyzed and no results are available.||||||
1330935|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the Last Acute Intravenous (iv) Administration That Occurred Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.||||||
1330936|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration on Day 1|This variable was not analyzed and no results are available.||||||
1330937|NCT02088957|Secondary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.||||||
1330938|NCT02088957|Primary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.||||||
1330939|NCT02088177|Primary|Number of Participants Receiving the Second Injection of Study Medication|The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.|Weeks 1 - 5||||Participants|||Count of Participants
1330940|NCT02088177|Primary|Change in Marijuana Use|Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1|Weeks 1 - 8||||days||Standard Deviation|Mean
1330942|NCT02087943|Secondary|Number of Participants With TEAEs During the Apremilast Exposure Period|A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg|Safety population includes all participants who received at least one dose of IP. These were Apremilast participants as treated.|||participants|||Number
1330943|NCT02087943|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period|A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 12|Safety population includes all participants who received at least one dose of IP.|||participants|||Number
1330944|NCT02087943|Secondary|The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4|The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 (“no pruritus”) to 10 (“the worst pruritus imaginable”). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.|Baseline to Week 4|All participants who were randomized as specified in the protocol and who received at least one dose of IP with a baseline and at least 1 postbaseline value at or before Week 4 were included. LOCF.|||percent change||Standard Error|Least Squares Mean
1330945|NCT02087943|Secondary|Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12|The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.|Baseline to Week 12|ITT includes all participants who were randomized as specified in the protocol and received at least one dose of IP. LOCF.|||percentage of participants|||Number
1330946|NCT02087943|Secondary|Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician’s Global Assessment of Acute Signs (sPGA-A) at Week 12.|The sPGA-A is intended to assess the global severities (ie, a “visual average” integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4).|Baseline to Week 12|ITT includes all participants who were randomized as specified per protocol and received at least one dose of IP. LOCF for missing data handling.|||percentage of participants|||Number
1330947|NCT02087943|Primary|Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.|EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.|Baseline to Week 12|All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12.|||percent change||Standard Error|Least Squares Mean
1330948|NCT02087774|Primary|Change From Baseline to After Intervention for After-Exercise Heart Rate|"Immediate cool-down, after-exercise heart rate was taken.~Difference in heart rate from baseline measurements is reported"|Baseline to 12 weeks later||||beats per minute||95% Confidence Interval|Mean
1330949|NCT02087774|Primary|Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes|"Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed.~Difference in laps completed from baseline was taken."|Baseline to 12 weeks later||||Difference in Laps Completed||95% Confidence Interval|Mean
1330950|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores while standing in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.~Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days||||units on a scale||Standard Deviation|Mean
1330951|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores at rest in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.~Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days||||units on a scale||Standard Deviation|Mean
1330952|NCT02087748|Primary|Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours|"The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days||||units on a scale||Standard Deviation|Mean
1330953|NCT02087670|Secondary|Oxygen Consumption||8 weeks||||ml/min||Standard Deviation|Mean
1330954|NCT02087670|Primary|Natriuretic Brain Pro-peptid||8 weeks||||pg/ml||Full Range|Median
1330955|NCT02087514|Primary|Non-transferrin-bound Iron Level (AUC)|Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).|0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion|52 out of the 60 enrolled subjects completed the study and were included in data analysis.|||microMole*hr/L||Inter-Quartile Range|Median
1330956|NCT02087423|Secondary|Duration of Response|"DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring – date of first response + 1). DoR was only analyzed for Cohort 2. Cohort 2: Median DoR was 12.3 months in the PD-L1 high (TC>=25%) group at DCO (Q3 was NR). Of the 7 evaluable subjects, the median DoR was not reached in the PD-L1 low/neg group (TC <25%); therefore the DoR number of participants analyzed field has been entered as 0 and the DoR results field has been left blank."|Time from response to progression, death, or last assessment||||Months||Inter-Quartile Range|Median
1330957|NCT02087423|Secondary|Time to Response|Time to response (per RECIST 1.1 as assessed by the ICR) is defined as the time from the date of first dose until the date of first documented response (which is subsequently confirmed). TTR was only analyzed for Cohort 2.|Responses recorded during 12 month treatment period||||Months||Full Range|Median
1330958|NCT02087423|Primary|Objective Response Rate|Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography (CT)/magnetic resonance imaging (MRI) were performed at the times specified in schedule of assessments. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the ICR were used to derive the primary variable of ORR .|Responses recorded during 12 month treatment period|The “FAS – evaluable for response per ICR” set, included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the ICR.|||% of patients evaluable for response||95% Confidence Interval|Number
1330959|NCT02087241|Secondary|Assess Overall Survival in Each Treatment Arm|Overall survival is defined as the time from the date of randomization until death due to any cause.|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|Overall Survival (OS) data were not collected.||||||
1330960|NCT02087241|Secondary|Assess the Duration of Response in Each Treatment Arm|Duration of response is defined as the time from the date of first documented response until the date of documented progression or any cause death.|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|Duration of response data were not collected.||||||
1330961|NCT02087241|Secondary|Assess the Disease Control Rate in Each Treatment Arm|the disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD).|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)||||Percentage of Participants||90% Confidence Interval|Number
1330962|NCT02087241|Secondary|Assess the Objective Response Rates in Each Arm|The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)||||Percentage of Participants||90% Confidence Interval|Number
1330963|NCT02087241|Primary|Progression Free Survival|Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.|6 months|Progression-Free Survival data were not collected.||||||
1330964|NCT02087176|Primary|Objective Response Rate|Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.|Up to 20 months|Thirty-two (32) subjects were enrolled in Part A, but the study was terminated early. Patients on-study at the time the study was terminated have been censored.|||Percentage of Participants||90% Confidence Interval|Number
1330965|NCT02087176|Secondary|Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel|Venous blood samples taken for determination of AZD1775, metabolites of 1775 on Cycle 1, Day 1 pre-dose and 2 hours post dose, Cycle 2 Day 1 pre-dose and 2 hours post dose, and Cycle 4 pre-dose and 2 hours post dose. However, the study was terminated early by the sponsor; therefore, pharmacokinetic data were not collected.|Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity|The study was terminated early by the sponsor. Pharmacokinetic data have not been analyzed.||||||
1330966|NCT02087059|Secondary|Summary of Summary of EORTC QLQ-C30 Responses by Time|The QLQ-C30 version 1.0 (QLQ-C30) incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|24 weeks|FAS|||units on a scale||Standard Deviation|Mean
1330967|NCT02087059|Secondary|Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time|The modified MFSAF v2.0 diary captures a patient's symptom severity on a scale of 0 (absent) to 10 (worst imaginable),with a maximal summary score of 60|24 weeks||||score on a scale||Standard Deviation|Mean
1330968|NCT02087059|Secondary|Charge in Spleen Size From Baseline up to the Specified Week|Number of patients with spleen length reduced by ≥ 50% up to specified week|Baseline, 24 weeks||||particiapants|||Number
1330969|NCT02087059|Secondary|Charge in Spleen Size From Baseline at Specified Week|Number of patients with spleen length reduced by ≥ 50% at specified week|Baseline, 24 weeks||||particiapants|||Number
1330970|NCT02087059|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24 weeks||||Participants|||Number
1330971|NCT02086786|Other Pre-specified|Positive and Negative Syndrome Scale (PANSS) Total Score|"The change in PANSS score from Baseline by visit 48.~The PANSS combines 3 subscales: The positive scale (7 items), the negative scale (7 items) and the general psychopathology scale (16 items).~PANSS Items Scores: 1 = Absent, 2 = Minimal, 3 = Mild, 4 = Moderate, 5 = Moderate Severe, 6 = Severe, 7 = Extreme.~Subscales are summed to compute a total score Range for each of the subscales: Positive scale (7-49); Negative scale (7-49); General psychopathology scale (16-112) Range for the PANSS total scale: 30-210 PANSS total score ≤70: stable schizophrenia PANSS total score between >70: decompensated schizophrenia"|Baseline, Days 5, 7, 10, 14, 18, and 21 post Dose 1; Dose 2, 3 and 4 post dose; Days 5, 7, 10, 14, 18, and 21 post Dose 2, 3, and 4; Days 25, 28, 32, 37, 42, 60, 75, 90, and 105 post Dose 4; Day 120 post Dose 4 or early termination.|The analysis was conduct in the Intent-to-Treat (ITT) Population, which includes all patients in Safety Population with baseline (Day -1) efficacy data and at least 1 post-baseline efficacy evaluation. ITT Population includes 66 patients; 33 on each arm.|||points||Standard Deviation|Mean
1330972|NCT02086786|Secondary|Accumulation Ratio (RA) for Active Moiety|Defined as AUC (0-28 days) after the 4th dose divided by the AUC (0-28 days) of the first dose.|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1330973|NCT02086786|Primary|PTF for Active Moiety|Peak to Trough Fluctuation ratio for the Active Moiety|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conduct in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1330974|NCT02086786|Primary|Terminal Half-life (t1/2) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 12 patients in the gluteal and 19 in the deltoid group had concentration amenable to evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1330975|NCT02086786|Primary|Time to Peak Concentration (Tmax) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||h||Full Range|Median
1330976|NCT02086786|Primary|AUCτ for Active Moiety|AUCτ is the area under the curve over the dosing interval (τ), where the dosing interval is 28 days|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population: 43 patients (20 in the gluteal and 23 in the deltoid site injection group). As determined by the pharmacokineticist, for Dose 4th analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1330977|NCT02086786|Primary|Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 11 patients in the gluteal and 18 in the deltoids had concentration amenable to evaluation.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1330978|NCT02086786|Primary|Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoids had concentration amenable to evaluation..|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1330979|NCT02086786|Primary|Trough Plasma Concentration (Cmin) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1330980|NCT02086786|Primary|Peak Plasma Concentration (Cmax) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1330981|NCT02086708|Primary|Measure Liver Elasticity Value Using Sonoelastography.|Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).|Day one||||kPa||95% Confidence Interval|Mean
1330982|NCT02086591|Other Pre-specified|Exploratory Objective|To investigate change in plasma matrix metalloproteinase 9 (MMP9) levels as a biomarker of treatment response; to assess plasma matrix metalloproteinase 9 (MMP9) expression by immunohistochemistry (IHC) and correlate to response in order to test the hypothesis that elevated intratumoral levels of plasma matrix metalloproteinase 9 (MMP9) can predict response to doxycycline. To assess activation/expression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kb) and Signal transducer and activator of transcription 3 (STAT 3) pathways in archived tumor by immunohistochemistry (IHC) to predict response or resistance to doxycycline.|One year|No data displayed because Outcome Measure has zero total participants analyzed||||||
1330983|NCT02086591|Secondary|Percentage of Patients With Progression Free Survival|Progression free survival is defined as the percentage of patients with stable disease or no death. Stable disease is defined as less than a partial response but is not progressive disease. Partial Response (PR)-At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses as determined byFDG-PET for CT scan. No increase should be observed in the size of other nodes, liver, or spleen. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients should be considered partial responders.|One year|Data was collected on all patients who were enrolled.|||percentage of participants|||Number
1330984|NCT02086591|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of patients with disease progression. Progression is defined as:~Appearance of a new lesion on fluorodeoxyglucose (FDG)-positron emission tomography or computerized tomography~≥50% increase in sum of the product of the node dimensions (SPD) of more than one node or in greatest diameter of any previously identified node >1 cm in its short axis from nadir.~To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Three months||||percentage of participants|||Number
1330985|NCT02085785|Secondary|Change in 6-minute Walk Distance|Change in 6-minute walk distance (ft) from baseline to follow-up|Baseline and at follow-up assessment (20-weeks after randomization)|Baseline carried forward if 20-week follow-up data not collected|||feet||95% Confidence Interval|Mean
1330986|NCT02085785|Secondary|Change in Weight|Changes between baseline and 20-weeks later (end of intervention)|Baseline and follow-up assessment (20-weeks after randomization)|Those who were not assessed at 20 weeks were assumed to have the same values as at baseline (last observation carried forward)|||pounds||95% Confidence Interval|Mean
1330987|NCT02085785|Secondary|Acceptability|Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend|At follow-up assessment (20-weeks follow-up)|Number who reported that they would recommend the program to a friend. Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information. The number analyzed are those who completed the 20-week follow-up measure.|||Participants|||Count of Participants
1330988|NCT02085785|Secondary|Feasibility - Retention|Number of randomized individuals who complete baseline and study exit visit|Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)||||participants|||Number
1331172|NCT02082184|Secondary|Time Spent <70 mg/dL and <55 mg/dL|Difference in time <70 mg/dL and <55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208||||hours per day||Standard Deviation|Mean
1330993|NCT02085720|Secondary|Prevalence of Restless Leg Syndrome (RLS)|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.|3 years||||% of participants|||Number
1330994|NCT02085720|Primary|Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly|Subjects who have completed the questionnaires and consented for sleep study are invited to undergo a portable at-home sleep study (EMBLETTA). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea hypopnea index (AHI) based on recording time. AHI is the average number of events per hour while 5-15 events per hour denotes mild OSA, 16-30 events moderate OSA, and >30 events severe OSA. Obstructive sleep apnea syndrome is defined as AHI 15 events or above or AHI being 5 or above pulus ESS 10 or more. This measure is reporting the percentage of participants with OSAS.|3 years||||% of participants|||Number
1330995|NCT02085161|Secondary|Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment|Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Liter||Standard Error|Least Squares Mean
1330996|NCT02085161|Secondary|One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment|One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Liter||Standard Error|Least Squares Mean
1330997|NCT02085161|Secondary|One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment|One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Liter||Standard Error|Least Squares Mean
1330998|NCT02085161|Secondary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Second||Standard Error|Geometric Mean
1330999|NCT02085161|Secondary|Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12|Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don’t do because of health reasons - 0, and don’t do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Units on a scale||Standard Error|Least Squares Mean
1331000|NCT02085161|Secondary|Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment|Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Multiple of 9.8*(meters / (second^2))||Standard Error|Least Squares Mean
1331001|NCT02085161|Secondary|Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12|Average daily walking time measured by the activity monitor in the week prior to Week 12.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Second||Standard Error|Least Squares Mean
1331002|NCT02085161|Primary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 8|Full analysis set (FAS): This patient set included all patients in the Treated set (TS) who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Second||Standard Error|Geometric Mean
1331003|NCT02084797|Other Pre-specified|Fluid Intake|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)|||||||
1331004|NCT02084797|Other Pre-specified|Performance|To determine if exercise performance, as determined by overall exercise time, was affected in response to the V2R antagonist, agonist and placebo conditions.|4 trials (4 weeks)|||||||
1331005|NCT02084797|Other Pre-specified|Sodium Palatability Ratings|To determine if sodium preference ratings were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)|||||||
1331006|NCT02084797|Other Pre-specified|Thirst Rating|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 trials (4 weeks)|||||||
1331007|NCT02084797|Other Pre-specified|Core Temperature|Measurement of core temperature using an ingestible CorTemp sensor during the V2R antagonist, agonist and placebo trials will allow researchers to assess if fluid homeostasis and thermoregulation were intertwined in response to each pharmacological intervention.|4 trials (4 weeks)|||||||
1331008|NCT02084797|Other Pre-specified|Body Weight|Changes in body weight during the V2R antagonist, agonist and placebo conditions will provide researchers with an additional measure of overall fluid balance (fluid in versus fluid out) as well as an estimate of overall sweat water losses.|4 trials (4 weeks)|||||||
1331009|NCT02084797|Secondary|Saliva Sodium Concentration|Measurement of salivary sodium concentration will allow us to determine if the V2R antagonist, agonist and placebo interventions activate aquaporin-5 (AQP5) water channels that are also located in sweat glands. If the V2R acts on the sweat glands through AQP5, there should be parallel changes in sweat, urine and saliva sodium concentrations with each pharmaceutical intervention.|4 trials (4 weeks)||||mEq/L||Standard Deviation|Mean
1331010|NCT02084797|Secondary|Blood Sodium Concentration|Measurement of blood sodium concentration will determine if normonatremia (blood sodium concentrations within the normal physiological range of 135-145mmol/L) were maintained throughout the trial with appropriate fluid intake during the V2R antagonist, agonist and placebo intervention trials.|4 study trials (4 weeks)||||mEq/L||Standard Deviation|Mean
1331011|NCT02084797|Secondary|Urine Sodium Concentration After the Steady-state Portion of the Trial|Changes in urine sodium concentration after use of the V2R antagonist, agonist and placebo interventions will verify whether or not pharmacologic activation or inhibition was successfully induced.|4 study trials (4 weeks)||||mEq/L||Standard Deviation|Mean
1331012|NCT02084797|Primary|Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial|Changes in sweat sodium concentration will parallel changes in urine sodium concentration with use of the V2R antagonist, agonist and placebo if the primary hypothesis is true (sweat sodium is regulated by the V2R, similar to how urine sodium is regulated by principle cells located within in the kidney collecting duct)|4 study trials (4 weeks)||||mEq/L||Standard Deviation|Mean
1331013|NCT02084706|Primary|Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection|Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced.|Our outcome measure was collected within the 60 seconds before and following the steroid injection.||||units on a scale||Standard Deviation|Mean
1331014|NCT02084628|Secondary|Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question|Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).|Images were taken pre-injection and post-injection (within about 15 minutes)||||number of responses|||Number
1331015|NCT02084628|Secondary|Change in Diagnosis for the Combined Images Compared With Precontrast Images|Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.|Images were taken pre-injection and post-injection (within about 15 minutes)||||participants|||Number
1331016|NCT02084628|Secondary|Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)||||participants|||Number
1331017|NCT02084628|Secondary|Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question|"Biliary system included~Gall bladder~Cystic duct~Common bile duct~Right main bile duct~Left main bile duct"|Images were taken pre-injection and post-injection (within about 15 minutes)||||number of responses|||Number
1331018|NCT02084628|Secondary|Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)||||number of responses|||Number
1331019|NCT02084628|Secondary|Number of Lesions Detected for the Combined Images||Images were taken pre-injection and post-injection (within about 15 minutes)||||number of lesions|||Number
1331020|NCT02084628|Secondary|Number of Lesions Detected for the Pre-contrast Images||Images were taken pre-injection||||number of lesions|||Number
1331021|NCT02084628|Primary|Number of Subjects With Serious Adverse Events|An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|From the signing of the informed consent form until the 6 month post MRI follow-up||||participants|||Number
1331022|NCT02084628|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.|From the signing of the informed consent form until the 6 month post MRI follow-up||||participants|||Number
1331023|NCT02084628|Primary|Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images|Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.|Images were taken pre-injection and post-injection (within about 15 minutes)||||participants|||Number
1331024|NCT02084238|Secondary|Safety Assessment|Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.|up to Day 180||2015-11-30|11/2015||||
1331025|NCT02084238|Secondary|Number of Relapses|Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months.|24 weeks||2015-11-30|11/2015||||
1331026|NCT02084238|Secondary|SELENA SLEDAI Score|"Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points, score> 8 means the disease is moderate-to-severe active."|week 0, week 10||||score||Standard Deviation|Median
1331027|NCT02084238|Secondary|The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients|Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.|week 0 and week 10||||g/L||Full Range|Median
1331028|NCT02084238|Secondary|Immunological Responses|Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study.|week 0 and week 10|regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells|||Percentage of CD4+ T cells||Full Range|Median
1331029|NCT02084238|Primary|Number of Participants Who Were SLE Responders (SRI)|SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.|week 2，week 4，week 6，week 8，week 10||||paticipants|||Number
1331030|NCT02084134|Secondary|Percentage of Patients Discharged on Glucocorticoids|Patient charts were reviewed to identify patients who were discharged on prednisone|1 day (Day of hospital discharge)||||Participants|||Count of Participants
1331031|NCT02084134|Primary|Number of Participants With Adrenal Insufficiency|Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test|6 weeks following surgery||||Participants|||Count of Participants
1331032|NCT02084082|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
1331033|NCT02084082|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1331034|NCT02084082|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331054|NCT02083965|Secondary|CL as Measured by Two-Stage Chromogenic Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1331035|NCT02084082|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
1331036|NCT02084082|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1331037|NCT02084082|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1331038|NCT02084069|Primary|Atrial Fibrillation Incidence After Open Cardiac Valve Repair||Within 5 days after open cardiac valve repair||||participants|||Number
1331039|NCT02084056|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 2000 fast and PKS 2000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1331040|NCT02084056|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1331041|NCT02084056|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331042|NCT02084056|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1331043|NCT02084056|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1331093|NCT02083380|Secondary|Kaplan-Meier Estimate of New Infection Rate|Kaplan-Meier estimate of number of patients with new infections|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% population with new infection|||Number
1331044|NCT02084056|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1331045|NCT02083965|Secondary|Development of Inhibitor as Measured by the Nijmegen-Modified Bethesda Assay|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the proportion of subjects with a confirmed inhibitor was calculated using the Clopper-Pearson method for a binomial proportion. Percentage of participants with confirmed inhibitor development was summarized overall.|Predose, Month 3, Month 6/early withdrawal. Additionally: If inhibitor suspected; at 10-15 EDs; 2-4 weeks prior to scheduled surgery; preoperatively on day of surgery; 1-2 weeks post-surgery; at last postoperative visit (last 2 for major surgery only)|The Safety Analysis Set included participants who received at least 1 dose of rFVIIIFc.|||percentage of participants||95% Confidence Interval|Number
1331046|NCT02083965|Secondary|Vz as Measured by Two-Stage Chromogenic Clotting Assay|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
1331047|NCT02083965|Secondary|DNAUC as Measured by Two-Stage Chromogenic Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1331048|NCT02083965|Secondary|AUCext as Measured by Two-Stage Chromogenic Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
1331049|NCT02083965|Secondary|Lambda Z as Measured by Two-Stage Chromogenic Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||1/h||95% Confidence Interval|Geometric Mean
1331050|NCT02083965|Secondary|AUClast as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1331051|NCT02083965|Secondary|Tmax as Measured by Two-Stage Chromogenic Clotting Assay|Time at which maximum activity (Cmax) is observed.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
1331052|NCT02083965|Secondary|MRT as Measured by Two-Stage Chromogenic Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
1331053|NCT02083965|Secondary|Vss as Measured by Two-Stage Chromogenic Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
1331173|NCT02082184|Secondary|Time in Range|Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range) using ANCOVA.|Baseline and Days 194 to 208||||hours per day||Standard Deviation|Mean
1331055|NCT02083965|Secondary|t½ as Measured by Two-Stage Chromogenic Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
1331056|NCT02083965|Secondary|Cmax as Measured by Two-Stage Chromogenic Clotting Assay|Maximum measured concentration of rFVIIIFc.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL||95% Confidence Interval|Geometric Mean
1331057|NCT02083965|Secondary|IR, K Value as Measured by Two-Stage Chromogenic Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1331058|NCT02083965|Secondary|AUCinf as Estimated From the FVIII Activity Data as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1331059|NCT02083965|Secondary|Terminal Exponential Volume of Distribution (Vz) as Measured by aPTT|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
1331060|NCT02083965|Secondary|Dose Normalized Area Under the Curve (DNAUC) as Measured by aPTT Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1331061|NCT02083965|Secondary|Percentage of AUCinf From the Last Data Point to Infinity (AUCext) as Measured by aPTT Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
1331062|NCT02083965|Secondary|Terminal Exponential Rate Constant (Lambda Z) as Measured by aPTT Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z) .|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||1/h||95% Confidence Interval|Geometric Mean
1331063|NCT02083965|Secondary|Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1331064|NCT02083965|Secondary|Time of Cmax (Tmax) as Measured by aPTT Clotting Assay|Time at which maximum activity (Cmax) is observed.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
1331065|NCT02083965|Secondary|Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
1331174|NCT02082184|Primary|HbA1c at 6 Months|Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.|Baseline and Day 194||||percentage of Glycated Haemoglobin||Standard Deviation|Mean
1331066|NCT02083965|Secondary|Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
1331067|NCT02083965|Secondary|Clearance (CL) as Measured by the aPTT Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1331068|NCT02083965|Secondary|Half-life (t½) as Measured by aPTT Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
1331069|NCT02083965|Secondary|Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay|Maximum measured concentration of rFVIIIFc.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL||95% Confidence Interval|Geometric Mean
1331070|NCT02083965|Primary|Incremental Recovery (IR, K Value) as Estimated From the FVIII Activity Data Measured by aPTT Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL||95% Confidence Interval|Geometric Mean
1331071|NCT02083965|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by Activated Partial Thromboplastin Time (aPTT) Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1331072|NCT02083861|Secondary|Muscle Strength Change From Baseline in Treated Knee|Muscle strength in flexion, extension, and rotation were measured using JTECH muscle testing equipment.|Baseline to 6 Weeks|17 patient subset was assessed for muscle strength pilot data.|||Newtons||95% Confidence Interval|Mean
1331073|NCT02083861|Secondary|Range of Motion Change From Baseline in Treated Knee|JTech equipment was used to evaluate range of motion range of motion using an inclinometer (www.jtechmedical.com) in flexion and extension of the treated knee. 0 degrees is fully extended and 150 degrees is normal flexion. Positive flexion change indicates improvement in flexion. Negative extension indicates improvement in extension.|Baseline, Week 6|17 patient subset was assessed for range of motion pilot data.|||Degrees||95% Confidence Interval|Mean
1331074|NCT02083861|Secondary|Quality of Life (WOMAC) Change From Baseline|WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index). WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400).|Baseline, Week 6|Patients that completed the entire study were included in analysis.|||units on a scale||95% Confidence Interval|Mean
1331075|NCT02083861|Primary|Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion|The numeric rating scale (NRS) was used to assess change in pain from baseline to study conclusion. NRS range from 0-10 with 0 being no pain and 10 the worst pain possible.|Baseline, Week 6|Patients that completed the entire study were included in analysis.|||units on a scale||95% Confidence Interval|Mean
1331094|NCT02083380|Secondary|Kaplan-Meier Estimate of Recrudescence|Kaplan-Meier estimate of number of patients with recrudescence|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% patients with recrudescence|||Number
1331095|NCT02083380|Secondary|Kaplan-Meier Estimate of Recurrence|Kaplan-Meier estimate of number of recurrent infections (either recrudescence or new infection)|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% population recurring|||Number
1331076|NCT02083679|Secondary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the first trial treatment given (Sym004 or one of the individual Platinum-Doublet therapies) or if they worsened after receiving first dose of treatment.|Day 1 up to 28 days after last dose of study drug (up to 53 weeks)|The safety analysis set included all 15 subjects who were administered any dose of the trial medication.|||subjects|||Number
1331077|NCT02083679|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not >5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not >5 days; fatigue/headache lasting < 7 days; nausea/vomiting/diarrhoea lasting not >3 days; asymptomatic Grade 3 increase in liver function tests that resolve to baseline within 7 days; Mucositis >= Grade 3 lasting < 7 days; Grade 3 hyperglycemia that resolves in < 7 days; any laboratory values >Grade 3 without any clinical correlate (resolve within 5 days); Grade 3 skin toxicities that resolve to Grade 2 within 7 days; Grade 3/4 hypomagnesemia that resolves within 5 days. Subjects with DLTs presented based on investigator and SMC decision.|Day 1 to Day 21 of Cycle 1|The dose limiting toxicity set included all 15 subjects in the safety analysis set (SAF) who received all planned trial medication doses during the first 21 days following the first dose of Sym004.|||Subjects|||Number
1331078|NCT02083406|Secondary|PQ Cmax|PQ Maximum observed concentration|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331079|NCT02083406|Secondary|Piperaquine (PQ) AUC(0-168h)|PQ Area under the plasma concentration versus time curve|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1331080|NCT02083406|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331081|NCT02083406|Primary|OZ439 AUC(0-168h)|OZ439 Area under the plasma concentration (AUC) versus time curve|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for pharmacokinetics (PK) parameter estimation|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1331082|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>=0.5 to <= 2 Years)|Artefenomel concentration on Day 7 in African Patients >= 0.5 to <=2 years. All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331083|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>2 to <= 5 Years)|Artefenomel concentration on Day 7 in African Patients >2 to <= 5 years. All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331084|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (> 5 Years)|Artefenomel concentration on Day 7 in African Patients > 5 years. All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331085|NCT02083380|Other Pre-specified|Artefenomel Cday7 Asian Patients (All Ages)|Artefenomel concentration on Day 7 in Asian Patients (all ages). All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331086|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>=0.5 to <= 2 Years)|Piperaquine concentration at Day7 in African patients >= 0.5 and <= 2 years|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331087|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>2 to <= 5 Years)|Piperaquine concentration at Day7 in African patients > 2 and <= 5years|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331088|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (> 5 Years)|Piperaquine concentration at Day7 in African patients > 5 years|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331089|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Asia (All Ages)|Piperaquine concentration at Day7 in Asian patients all ages|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331090|NCT02083380|Secondary|PRR48|Parasite reduction ratio at 48 hours post dose|0, 6, 12, 18, 24, 30, 36 and 48 hours post dose|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. Subjects with sufficient data points to determine PRR48|||ratio||Inter-Quartile Range|Median
1331091|NCT02083380|Secondary|Fever Clearance Time|Time to fever clearance (hours)|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||hours||95% Confidence Interval|Median
1331092|NCT02083380|Secondary|Parasite Clearance Time|Time post dose to parasite clearance|0, 6, 12, 18, 24, 30, 36, 48 and 72 hours post dose|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||hours||95% Confidence Interval|Median
1331767|NCT02071849|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
1331096|NCT02083380|Secondary|Crude ACPR at Day 63 in the ITT Population|Crude adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
1331097|NCT02083380|Secondary|Crude ACPR at Day 42 in the ITT Population|Crude adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
1331098|NCT02083380|Secondary|Crude ACPR at Day 28 in the ITT Population|Crude adequate clinical and parasitological response at Day 28 in the ITT population|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
1331099|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331100|NCT02083380|Secondary|PCR-adjusted ACPR at Day 42 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331101|NCT02083380|Secondary|PCR-adjusted ACPR at Day 28 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 28. Intent to Treat ( ITT) population.|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331102|NCT02083380|Secondary|Crude ACPR at Day 63 in the PP Population|Crude adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
1331103|NCT02083380|Secondary|Crude ACPR at Day 42 in the PP Population|Crude adequate clinical and parasitological response at Day 42|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR unajusted (crude)||95% Confidence Interval|Number
1331104|NCT02083380|Secondary|Crude ACPR at Day 28 in the PP Population|Crude adequate clinical and parasitological response at Day 28|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
1331105|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the PP Population|PCR-adjusted adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331106|NCT02083380|Secondary|PCR - Adjusted ACPR at Day 42 in the PP Population|PCR - adjusted adequate clinical and parasitological response at Day 42|Days 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331107|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331108|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331109|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331110|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331111|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331112|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331113|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population (All Patients)|"Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP).~95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
1331114|NCT02083263|Secondary|Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).|After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.|1 month|||||||
1331115|NCT02083263|Primary|Lung Function: Lung Clearance Index|Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.|up to 3 months||||lung clearance index||Standard Deviation|Mean
1331116|NCT02083185|Secondary|Change From Baseline in EORTC QLQ-C30|The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A positive change from Baseline in quality og life or functioning scales and negative change from Baseline in symptom or difficulties scales indicates improvement.|Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||score on a scale||Standard Deviation|Mean
1331128|NCT02083185|Secondary|Number of Participants With TEAES Related to Clinical Laboratory Test Results|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1331768|NCT02071849|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
1331117|NCT02083185|Secondary|Percent Change From Baseline of Aging Male Survey (AMS) Total Score|AMS scale is a self-administered questionnaire used to: 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between 1=none to 5=extremely severe for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.|Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||percent change||Standard Deviation|Mean
1331118|NCT02083185|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score|EORTC QLQ-PR25 is an EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer consisting of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions use are answered using a 4-point scale: 1=Not at all to 4 =Very much. All raw domain scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). A positive change from Baseline in activity or functioning scales and negative change from Baseline in symptom scales indicates improvement.|Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||score on a scale||Standard Deviation|Mean
1331119|NCT02083185|Secondary|Serum Sex Hormone-binding Globulin (SHBG) Concentrations|Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility.|Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
1331120|NCT02083185|Secondary|Serum Follicle Stimulating Hormone (FSH) Concentrations|Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility.|Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||IU/L||Standard Deviation|Mean
1331121|NCT02083185|Secondary|Serum Luteinizing Hormone (LH) Concentrations|Blood was collected and serum concentrations of LH in milli international units per milliliters (mIU/mL) were obtained using a validated laboratory test at a central laboratory facility.|Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||mIU/mL||Standard Deviation|Mean
1331122|NCT02083185|Secondary|TAK-385 Plasma Concentrations||Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dose|Safety population included all randomized participants who received at least 1 dose of study drug (TAK-835). Here 'n' is the number of participants analyzed at the specific timepoint.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1331123|NCT02083185|Secondary|Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL||During Weeks 1 to 24|Safety population included all randomized participants who received at least 1 dose of study drug. If a participant has all post first dose testosterone measurements >= 50 ng/dL, the participant’s time to castration was censored at the last testosterone measurement that is >= 50 ng/dL.|||days||Full Range|Median
1331124|NCT02083185|Secondary|Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24|Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility.|Day 1 of Weeks 13 and 25|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||μg/L||Standard Deviation|Mean
1331125|NCT02083185|Secondary|Prostate-Specific Antigen Nadir|PSA nadir is the lowest PSA achieved after treatment.|During Weeks 1 to 24|Safety population included all randomized participants who received at least 1 dose of study drug. Here number of participants analyzed are participants evaluable for this outcome measure.|||micrograms per liter (µg/L)||Standard Deviation|Mean
1331126|NCT02083185|Secondary|Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks|PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction.|Week 5, Day 1|Safety population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1331127|NCT02083185|Secondary|Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any AE that results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1331129|NCT02083185|Secondary|Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings|A single 12-lead ECG was performed. ECGs were read and interpreted locally and reviewed if indicated by the study monitor. ECG abnormalities were reported as AEs.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1331130|NCT02083185|Secondary|Number of Participants With TEAEs Related to Physical Examination|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10) including slit lamp examination of the anterior eye. Any TEAEs Related to physical examination were reported.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1331131|NCT02083185|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs|Vital signs included oral temperature, pulse rate, supine systolic and diastolic blood pressure, standing systolic and diastolic blood pressure, and weight. Any TEAEs that were associated with vital signs were reported.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1331132|NCT02083185|Primary|Percentage of Participants With Effective Castration Rate Over 24 Weeks|Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits beginning after 4 weeks of treatment.|Day 1 of Week 5 to Day 1 of Week 25|Safety population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1331133|NCT02083107|Other Pre-specified|Change in Hematocrite Value||24 hours postoperative from baseline hematocrite value||||Percentage Hematocrit||Standard Deviation|Mean
1331134|NCT02083107|Secondary|Incidence of Adverse Effects||24 hours||||no. of cases experiencing side effects|||Number
1331135|NCT02083107|Secondary|Incidence of Wound Sepsis||upto one week||||no. of cases experiencing wound sepsis|||Number
1331136|NCT02083107|Secondary|Need for Postoperative Blood Transfusion||average 24 hours||||participants|||Number
1331137|NCT02083107|Secondary|Need for Extra Analgesics||average 24 hours||||participants|||Number
1331138|NCT02083107|Secondary|Time to Resume Bowel Habits||average 24 hours||||hours||Standard Deviation|Mean
1331139|NCT02083107|Secondary|APGAR Score|The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).|1minute and 5 minutes from delivery of the fetus||||units on a scale||Standard Deviation|Mean
1331140|NCT02083107|Other Pre-specified|Change in Hemoglobin Concentration||24 hours postoperative from baseline hemoglobin||||gram/dL||Standard Deviation|Mean
1331141|NCT02083107|Secondary|Need for Extra Ecbolics (Oxytocin).||from start of cesarean section till the end of operation (average one hour)||||participants|||Number
1331142|NCT02083107|Primary|Intraoperative Blood Loss||from start of cesarean section till the end of operation (average one hour)||||millilitres||Standard Deviation|Mean
1331143|NCT02082912|Secondary|Change in Functional Motor Task Performance||Baseline and at end of 3 weeks of treatment|||||||
1331144|NCT02082912|Secondary|Change in Memory and Information Processing Speed||Baseline and at end of 3 weeks of treatment|||||||
1331145|NCT02082912|Secondary|Change in Depressive Symptoms||Baseline and at end of 3 weeks of treatment|||||||
1331146|NCT02082912|Secondary|Change in Stroke Impact Scale Score||Baseline and at end of 3 weeks of treatment|||||||
1331147|NCT02082912|Primary|Mean Change in Grip Strength of Affected Hand|Hand-grip strength was assessed using the whole hand and defined as the average of 3 trials using a calibrated Jamar dynamometer (Jamar Dynamometer, Asimow Engineering Co., Santa Monica, CA), with the elbow flexed to 90º and the forearm in a neutral position. This is the standardized method for measuring hand-grip strength with a Jamar dynamometer recommended by the American Society of Hand Therapists. Change was calculated by subtracting baseline from outcome at week 3.|Baseline, 3 weeks (end of treatment)||||Newton||Standard Deviation|Mean
1331148|NCT02082769|Other Pre-specified|Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline||Baseline and Final Visit (up to 26 weeks)||||umol/l||Standard Deviation|Mean
1331149|NCT02082769|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit||Final Visit (up to 26 weeks)||||percentage of participants|||Number
1331150|NCT02082769|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)||Last 3 visits (any last 3 visits up to week 26)||||percentage of participants|||Number
1331151|NCT02082392|Secondary|Blind Assessment—Patient Version|rates subject's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.|8 weeks|Data were not collected||||||
1331152|NCT02082392|Secondary|California Pharmacotherapy Alliance Scale (CALPAS)—Patient Version|24 item Likert scale rating the patient's assessment of the therapeutic alliance, particularly about medication issues, with the clinician. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy.|8 weeks|Data were not collected||||||
1331153|NCT02082392|Secondary|Schedule for Adaptive and Nonadaptive Personality (SNAP)|this questionnaire is a widely used assessment tool for personality disorders that we will also use to identify predictors of response to varying visit frequency.|8 weeks|Data were not collected||||||
1331154|NCT02082392|Secondary|Revised Life Orientation Test (LOT-R)|scale developed to assess individual differences in generalized optimism versus pessimism. Degree of optimism on this scale has been correlated with the magnitude of placebo response observed in studies of placebo analgesia, and we will determine whether LOT-R scores moderate effects of therapeutic contact.|8 weeks|Data were not collected||||||
1331155|NCT02082392|Secondary|Cornell Treatment Preference Index|"scale used in mental health studies to document the type and strength of patients' treatment preferences. We will use a modified version in this study asking subjects Based on your experience and how you feel right now, which of the visit frequencies in this study would be your first choice? The strength of this preference will be measured on a 5-point Likert scale."|8 weeks|Data were not collected||||||
1331156|NCT02082392|Secondary|Client Satisfaction Questionnaire 8 (CSQ 8)|self-administered scale with items rating respondents’ satisfaction with mental health services they are receiving on a 4 point Likert scale. Use of the CSQ 8 will allow us to determine whether CFM and RFM are associated with differences in participant satisfaction.|8 Weeks|Data were not collected||||||
1331157|NCT02082392|Secondary|Treatment Credibility and Expectancy Scale (CES)|"8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. For this study, the primary measure of expectancy will be item 4: By the end of the treatment period, how much improvement in your depressive symptoms do you think will occur? (0-100%)."|8 Weeks|Data were not collected||||||
1331158|NCT02082392|Secondary|Quick Inventory of Depressive Symptoms—Self Report (QIDS-SR) 16 Item Scale|rating scale for depressive symptoms based on DSM criteria. A self-report measure for depressive symptoms is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies (e.g., STAR*D) due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression|8 Weeks|Data were not collected||||||
1331159|NCT02082392|Secondary|Blind Assessment—Clinician Version|Rates clinician's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.|8 weeks|Data were not collected||||||
1331160|NCT02082392|Secondary|California Pharmacotherapy Alliance Scale (CALPAS)—Clinician Version|24 item Likert scale rating the clinician's assessment of the therapeutic alliance, particularly about medication issues, with the patient. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy. Prior studies using the CALPAS reported an association between therapeutic alliance and outcome, and some studies found alliance mediated the effect of expectancy on depression outcome.|Baseline week|Data were not collected||||||
1331161|NCT02082392|Secondary|Treatment Emergent Symptom Scale|rating scale for physical symptoms reported during the study. This is a standard means of recording drug-related adverse effects that will allow us to assess whether contact frequency is associated with differences in side effects among study subjects.|Baseline week|Data were not collected||||||
1331162|NCT02082392|Secondary|CGI Severity and Improvement|"scales developed to measure the clinician’s view of subjects’ global functioning before and after initiating a study medication. The CGI correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points.~7-point scale: 0 = Not assessed 4 = Moderately ill~1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients"|Baseline week||||units on a scale||Standard Deviation|Mean
1331163|NCT02082392|Secondary|Hamilton Anxiety Rating Scale (HARS) 14-item Scale|Scale for anxiety symptoms administered by trained rater. The HARS is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0–56, where <17 indi-cates mild severity, 18–24 mild to moderate severity and25–30 moderate to severe.|Baseline week||||units on a scale||Standard Deviation|Mean
1331164|NCT02082392|Primary|Hamilton Rating Scale for Depression|"scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 17 items.~sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression"|Baseline week||||units on a scale||Standard Deviation|Mean
1331165|NCT02082288|Primary|Clinical Pregnancy|A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.|6 weeks||||participants|||Number
1331166|NCT02082262|Primary|Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale|Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Day 70|Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score|||Scores on a Scale||Standard Deviation|Mean
1331167|NCT02082184|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).~There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).~The ANCOVA adjusts for baseline DTSQs (status version)."|Baseline and Day 194||||units on a scale||Standard Deviation|Mean
1331168|NCT02082184|Secondary|System Utilisation|Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.|Days 15 to 208|138 subjects included in the analysis, 11 were not included due to missing data.|||percentage of sensor glucose collected||Standard Deviation|Mean
1331175|NCT02082158|Secondary|To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs|Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.|||units on a scale||Standard Deviation|Mean
1331176|NCT02082158|Primary|To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs|Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.|||units on a scale||Standard Deviation|Mean
1331177|NCT02081859|Secondary|Implantation Rate|Percent of embryos implanted assessed at time of ultrasound|6 weeks||||Percentage of embryos|||Number
1331178|NCT02081859|Primary|Clinical Pregnancy Rate|Patients will have a ultrasound to document fetal heart rate approximately 6 weeks after start of IVF cycle.|6 weeks||||Participants|||Count of Participants
1331179|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT|"The Cognitive/Emotional Impacts domain consists of 4 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to not at all/with no difficulty at all and value 4 corresponds to very much/extremely/ not able at all. The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Cognitive/Emotional Impacts domain score is determined based on the 4 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Mean
1331180|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT|"The Physical Impacts domain consists of 7 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to not at all/with no difficulty at all and value 4 corresponds to very much/extremely/ not able at all. The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Physical Impacts domain score is determined based on the 7 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Mean
1331181|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT|"The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to no symptoms and value 4 corresponds to very severe symptoms. The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiovascular Symptoms domain score is determined based on the daily scores of the 5 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Median
1331182|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT|"The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means no symptom and value 4 corresponds to very severe symptoms.The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Mean
1331183|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Variable Vision)|The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331253|NCT02081014|Secondary|Glucagon Area Under the Curve (AUC) (Fasting)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(pg/ml)*hour||Standard Error|Mean
1331184|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Redness)|The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331185|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Lens Awareness)|The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331186|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)|The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331187|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Irritation/Discomfort)|The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331188|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)|The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331189|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Dryness)|The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331190|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)|The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331191|NCT02081677|Primary|Tarsal Abnormalities|Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported.|1-, 2- and 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
1331192|NCT02081677|Primary|Corneal Staining|Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
1331193|NCT02081677|Primary|Corneal Neovascularization|Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
1331194|NCT02081677|Primary|Conjunctival Injection|Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
1331195|NCT02081677|Primary|Corneal Edema|Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
1331254|NCT02081014|Secondary|Glucagon Cmax (Post-insulin)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subject who received at least one dose of study drug|||pg/ml||Standard Error|Mean
1331196|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Burning/Stinging)|The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331197|NCT02081677|Primary|Lens Fitting Characteristics|Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.|Post Lens Fitting and 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
1331198|NCT02081677|Primary|Visual Acuity (LogMAR)|Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.|4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Eyes|Standard Deviation|Mean
1331199|NCT02081677|Primary|Bulbar Conjunctival Redness|Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.|Baseline and 2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale|Subject Eye|Standard Deviation|Mean
1331200|NCT02081677|Primary|Limbal Conjunctival Redness|Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.|Baseline and 2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale|Subject Eye|Standard Deviation|Mean
1331201|NCT02081677|Primary|Corneal Staining (Type)|Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.|||Units on a scale|Subject Eyes|Standard Deviation|Mean
1331202|NCT02081677|Primary|Corneal Staining (Depth)|Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.|||Units on a scale|Subject Eyes|Standard Deviation|Mean
1331203|NCT02081677|Primary|Corneal Staining (Area)|Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.|||Units on a scale|Subject Eyes|Standard Deviation|Mean
1331204|NCT02081599|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg/dL||Standard Error|Least Squares Mean
1331205|NCT02081599|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*hr/dL||Standard Error|Least Squares Mean
1331206|NCT02081599|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.|||mg/dL||Standard Error|Least Squares Mean
1331255|NCT02081014|Secondary|Glucagon Cmax (Fasting)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||pg/ml||Standard Error|Mean
1331207|NCT02081599|Primary|Change From Baseline in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1331208|NCT02081586|Secondary|Body Mass Index Change|Change in Body Mass Index from baseline to post intervention|baseline to 16 weeks|Of 13 initially randomized, there were 2 dropouts and one was withdrawn from the study.|||kg/m^2||Full Range|Mean
1331209|NCT02081586|Secondary|Diabetes Distress Scale- Change Score|Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Percent change of mean score between baseline and 16 weeks is reported. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.|baseline to 16 weeks|Of thirteen initially randomized, one was withdrawn prior to treatment, one is missing data, and two dropped out. Therefore we do not have change scores for these pariticipants.|||percent change||Full Range|Mean
1331210|NCT02081586|Secondary|MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence|Electronically measured medication adherence, percent adherence over entire study phase. Change score was not evaluated, this measure is to determine feasability of use over time. Percent adherence is measured by the number of correct doses per day divided by the number of prescribed doses per day X 100. Percent adherence was calculated as the percentage of the prescribed doses of the medication actually taken by the patient over 16 weeks|16 weeks||||percent adherent||Full Range|Mean
1331211|NCT02081586|Primary|Computer System Usability Questionnaire (CSUQ)|"The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78.~Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability."|16 weeks|As per protocol, usability was analyzed for participants administered phone CBT, regardless of duration. Six subjects completed the CSUQ. Of ten initially assigned treatment, one was withdrawn prior to treatment, one missed the CSUQ, and two dropped out. Treatment as usual Arm did not use the phone.|||units on a scale (1-7)||Standard Deviation|Mean
1331212|NCT02081586|Primary|HbA1c Level Change Scores From Baseline to 16 Weeks|Change from baseline HbA1c level to post intervention|baseline to 16 weeks|per protocol|||percent||Standard Deviation|Mean
1331213|NCT02081573|Secondary|Body Mass Index|Change in Body Mass Index from before to after treatment|12 weeks|Change BMI over time.|||kg/m^2||Standard Deviation|Mean
1331214|NCT02081573|Secondary|HbA1c Level|Change in HbA1c from before to after treatment|12 weeks||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1331215|NCT02081573|Secondary|Medication Beliefs Scale|Change in medication beliefs from before and after intervention. Adapted from Horne, R., Weinman, J., Hankins, M. (1999). The Beliefs About Medicines Questionnaire: The Development and Evaluation of a New Method for Assessing the Cognitive Representation of Medications. Psychology and Health 14: 1-24.|12 weeks|||||||
1331216|NCT02081573|Secondary|Diabetes Distress Scale|Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Change of mean score is reported. Change in score from baseline to post followup. Lower score means less distress. Scale range is from 1-6. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.|12 weeks|Change in score from baseline to post followup|||mean of scale items||Standard Deviation|Mean
1331217|NCT02081573|Secondary|Morisky Questionnaire|Brief scale of adherence to medications. Morisky 5 items was used. Mean score presented. Scale range is from 5-13. Lower score is better adherence. Mean change from baseline to 12 weeks is examined.|12 weeks|Mean change from baseline to 12 weeks.|||mean of scale items||Standard Deviation|Mean
1331218|NCT02081573|Primary|Acceptability Questionnaire.|The acceptability questionnaire measures feasibility and acceptability of the Brief CBT protocol. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean and ranges from 1-7. In this adaptation, lower scores are better satisfaction.|12 weeks|Mean acceptability of the Brief CBT protocol.|||mean of scale items||Standard Deviation|Mean
1331219|NCT02081443|Secondary|PRI Measured by VASP|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|4 hours||||%PRI||Standard Error|Mean
1331220|NCT02081443|Secondary|PRI Measured by VASP|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|1 hour||||%PRI||Standard Error|Mean
1331221|NCT02081443|Primary|Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|Baseline||||%PRI||Standard Error|Mean
1331222|NCT02081365|Secondary|Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment||||units on a scale||Standard Error|Mean
1331223|NCT02081365|Secondary|Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment||||units on a scale||Standard Error|Mean
1331224|NCT02081365|Secondary|Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants’ anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients’ overall distress and impairment due to their dental phobia symptoms and assigned a clinician’s severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before dental appointment to one-month after dental appointment||||units on a scale||Standard Error|Mean
1331225|NCT02081365|Primary|Change in Modified Dental Anxiety Scale|The Modified Dental Anxiety Scale a five-item self-report measure that assesses fear of dental procedures, including drilling, scaling and polishing (i.e., cleaning), and local anesthetic injections. Sample items include, “If you went to your dentist for treatment tomorrow, how would you feel?” and “If you were about to have your tooth drilled, how would you feel?” Items are rated on a five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored > 19 on the MDAS at baseline or endorsed at least two MDAS items > 4 to have high dental anxiety.|Change from one week before dentist appointment to 1 month after dentist appointment||||units on a scale||Standard Error|Mean
1331226|NCT02081248|Secondary|Consent Rate on Parent Trial|The consent rate is the rate at which participants provided consent to participate in the parent trial.|Within 7 days of consent discussion|Consent rates are computed specific to each trial|||Participants|||Count of Participants
1331227|NCT02081248|Secondary|Participant Information Location Time|Participants are asked to identify select items within the consent document and the time taken to locate items is measured. Patients who were not able to identify a given section were assigned the maximum time allotted to find each section (180 seconds).|Within 7 days of consent discussion|Participants completing the information location assessment|||seconds||Inter-Quartile Range|Median
1331228|NCT02081248|Secondary|Participant Satisfaction With Consent Process|A short study specific questionnaire and selected questions from the Quality of Informed Consent (QuIC) supplement questionnaire will query participants about their overall satisfaction with the consent process, helpfulness of information provided, and comprehension of key study-specific elements of treatment. Seven questions are included, each scored on a five point Likert scale. The overall score is the average of the item scores, ranging from 1.0 to 5.0, with a higher score indicating a higher level of satisfaction.|Within 7 days of consent discussion|Participants completing the satisfaction questionnaire|||units on a scale||Inter-Quartile Range|Median
1331229|NCT02081248|Secondary|State Trait Anxiety Inventory (STAI) Score|The State Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes. It has two subscales: the State Anxiety Scale evaluates the current state of anxiety, asking how respondents feel “right now,” and Trait Anxiety Scale evaluating relatively stable aspects of “anxiety proneness”. The STAI has 40 items, 20 items allocated to each subscale, with each item scored on a 4 point Likert scale. The subscale scores shown are averages of the items in the subscale ranging from 1.0 to 4.0, with a higher score indicating a greater level of anxiety.|Within 7 days of consent discussion|Participants completing the STAI assessment|||units on a scale||Inter-Quartile Range|Median
1331230|NCT02081248|Secondary|Newest Vital Sign (NVS) Score|The Newest Vital Sign is a screening tool that identifies patients at risk for low health literacy. It consists of a nutritional label accompanied by five questions about information on the label. The score is equal to the number of questions answered correctly.|Within 7 days of consent discussion||||Participants|||Count of Participants
1331231|NCT02081248|Secondary|REALM-R Score|The Rapid Estimate of Adult Literacy in Medicine—Revised (REALM-R) is an 8-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. The score is computed as the number of words out of 8 that the patient pronounces correctly.|Within 7 days of consent discussion||||Participants|||Count of Participants
1331232|NCT02081248|Secondary|Modified Deaconess Informed Consent Comprehension Test (DICCT)|The Modified Deaconess Informed Consent Comprehension Test (DICCT) uses semi-structured interviews to assess subject's understanding of the study for which they participated in an informed consent discussion. This modification of the DICCT has 11 items, each scored from 0 to 2 (0 = incorrect, 1 = partially correct, 2 = correct). The item scores are summed to produce a total score ranging from 0 to 22. A higher score indicates a higher level of comprehension.|WIthin 7 days of consent discussion|Participants completing the modified DICCT assessment|||units on a scale||Inter-Quartile Range|Median
1331233|NCT02081248|Secondary|Quality of Informed Consent Part B (QuIC-B) Score|The Quality of Informed Consent Part B measures participants' perception of their understanding of cancer clinical trials to address 13 independent domains of informed consent. The QuIC-B is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of perceived understanding.|Within 7 days of consent discussion|Participants completing the QuIC-B assessment|||units on a scale||Inter-Quartile Range|Median
1331256|NCT02081014|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment|From first dose until follow-up call, up to 7 weeks per subject|All randomized subjects who received at least one dose of study drug|||participants|||Number
1331234|NCT02081248|Primary|Quality of Informed Consent Part A (QuIC-A) Score|The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.|Within 7 days of consent discussion|Participants completing the QuIC-A assessment|||units on a scale||Standard Deviation|Mean
1331235|NCT02081183|Primary|Serum Albumin|Albumin is a protein made by the liver. A serum albumin test measures the amount of this protein in the clear liquid portion of the blood. Decreased serum albumin levels can be an indicator of liver and/or kidney disease, The normal range is 3.4 - 5.4 grams (g)/dL.|18 months|Data were not analyzed because the study was terminated early.||||||
1331236|NCT02081183|Primary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly participants typically have smaller muscle mass.|18 months|Data were not analyzed because the study was terminated early.||||||
1331237|NCT02081183|Primary|Urinary Protein|Protein in urine is an indicator of kidney function. An increased urinary protein level indicates decreased kidney function. Normal values are approximately 0 to 8 milligrams per deciliter (mg/dL).|18 months|Data were not analyzed because the study was terminated early.||||||
1331238|NCT02081183|Primary|Creatinine Clearance|Creatinine clearance in an indicator of kidney function. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult values are 97 to 137 milliliters per minute (mL/min) for males and 88 to 128 mL/min for females.|18 months|Data were not analyzed because the study was terminated early.||||||
1331239|NCT02081079|Secondary|Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12||Baseline; Weeks 2, 4, 8, and 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1331240|NCT02081079|Secondary|Percentage of Patients With Virologic Failure|"Virologic failure was defined as either:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or~Relapse:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment"|Up to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1331241|NCT02081079|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1331242|NCT02081079|Primary|Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1331243|NCT02081079|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 or 5 HCV infection who were enrolled and received at least on dose of study drug.|||percentage of participants|||Number
1331244|NCT02081014|Secondary|Glucose Tmax (Post-insulin)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
1331245|NCT02081014|Secondary|Glucose Tmax (Fasting)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
1331246|NCT02081014|Secondary|Glucose AUC (Post-insulin)|Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(mg/dl)*minutes||Standard Error|Mean
1331247|NCT02081014|Secondary|Glucose AUC (Fasting)|Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(mg/dl)*minutes||Standard Error|Mean
1331248|NCT02081014|Secondary|Glucose Cmax (Post-insulin)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||mg/dl||Standard Error|Mean
1331249|NCT02081014|Secondary|Glucose Cmax (Fasting)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||mg/dl||Standard Error|Mean
1331250|NCT02081014|Secondary|Glucagon Tmax (Post-insulin)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
1331251|NCT02081014|Secondary|Glucagon Tmax (Fasting)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
1331252|NCT02081014|Secondary|Glucagon AUC (Post-insulin)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(pg/ml)*hour||Standard Error|Mean
1331257|NCT02081001|Secondary|Infusion Site Discomfort Score at 30 Minutes|Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 30 minutes post-dosing|All treated subjects|||mm||Standard Deviation|Mean
1331258|NCT02081001|Secondary|Infusion Site Discomfort Score at 10 Minutes|Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 10 minutes post-dosing|All treated subjects|||mm||Standard Deviation|Mean
1331259|NCT02081001|Secondary|Glucose AUC|Area under the plasma concentration time curve for glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||(mg/dl)*minutes||Standard Deviation|Mean
1331260|NCT02081001|Secondary|Glucagon AUC|Area under the plasma concentration time curve for glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||(pg/dl)*minutes||Standard Deviation|Mean
1331261|NCT02081001|Secondary|Glucose Tmax|Time to maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.|||minutes||Standard Deviation|Mean
1331262|NCT02081001|Secondary|Glucagon Tmax|Time to maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||minutes||Standard Deviation|Mean
1331263|NCT02081001|Secondary|Glucose Cmax|Maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||mg/dl||Standard Deviation|Mean
1331264|NCT02081001|Secondary|Glucagon Cmax|Maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||pg/dl||Standard Deviation|Mean
1331265|NCT02081001|Primary|Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)|The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||minutes||Standard Deviation|Mean
1331266|NCT02081001|Primary|Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)|The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.|||minutes||Standard Deviation|Mean
1331267|NCT02080871|Other Pre-specified|Major Amputation|Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome|9 Months|Population includes subjects followed for at least 240 days.|||Participants|||Count of Participants
1331268|NCT02080871|Other Pre-specified|Target Lesion Revascularization (TLR)|Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome|9 Months|Population includes subjects followed for at least 240 days.|||Participants|||Count of Participants
1331269|NCT02080871|Other Pre-specified|Myocardial Infarction (MI)|Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome|30 Days|Population includes subjects followed for at least 30 days.|||Participants|||Count of Participants
1331270|NCT02080871|Other Pre-specified|Device or Procedure-related Death|Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome|30 Days|Population includes subjects followed for at least 30 days.|||Participants|||Count of Participants
1331271|NCT02080871|Secondary|Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)|Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
1331272|NCT02080871|Secondary|Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)|Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
1331273|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Own Health State|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
1331274|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Own Health State|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
1331275|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
1331276|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
1331277|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
1331278|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
1331279|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Usual Activities|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
1331280|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Usual Activities|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
1331281|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Self Care|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
1331282|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Self Care|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
1331283|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Mobility|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
1331284|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Mobility|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
1331285|NCT02080871|Secondary|Change in Ankle Brachial Index (ABI)|Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||ratio index|limbs|Full Range|Mean
1331286|NCT02080871|Secondary|Change in Ankle Brachial Index (ABI)|Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||ratio index|limbs|Full Range|Mean
1331287|NCT02080871|Secondary|Number of Participants With Change in Rutherford Category|"Number of participants with change in Rutherford Category from pre-procedure at 9 months.~Rutherford Categories:~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene"|9 Months|Population includes subjects followed for at least 240 days and relevant data.|||Participants|||Count of Participants
1331288|NCT02080871|Secondary|Number of Participants With Change in Rutherford Category|"Number of participants with change in Rutherford Category from pre-procedure at 30 days.~Rutherford Categories:~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene"|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
1331289|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)|Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1331290|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)|Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1331293|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)|Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1331294|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)|Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1331295|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1331296|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
1331297|NCT02080871|Secondary|Percentage of Participants With Secondary Patency|Kaplan-Meier estimate of secondary patency at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
1331298|NCT02080871|Secondary|Percentage of Participants With Secondary Patency|Kaplan-Meier estimate of secondary patency at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
1331299|NCT02080871|Secondary|Percentage of Participants With Primary Assisted Patency|Kaplan-Meier estimate of primary assisted patency at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
1331300|NCT02080871|Secondary|Percentage of Participants With Primary Assisted Patency|Kaplan-Meier estimate of primary assisted patency at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
1331301|NCT02080871|Secondary|Percentage of Participants With Primary Patency|Kaplan-Meier estimate of primary patency at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
1331302|NCT02080871|Secondary|Percentage of Participants With Primary Patency|Kaplan-Meier estimate of primary patency at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
1331303|NCT02080871|Secondary|30-Day Clinical Success|Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
1331304|NCT02080871|Secondary|Acute Procedural Success|Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.|Discharge|Population includes subjects followed through discharge and had relevant procedural data.|||Participants|||Count of Participants
1331305|NCT02080871|Primary|Composite of Major Adverse Events (MAEs)|Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.|9 months|Population includes enrolled subjects who either experienced the defined event or were followed for at least 240 days.|||percentage of subjects experiencing MAE||95% Confidence Interval|Number
1331306|NCT02080832|Other Pre-specified|fMRI Brain Activation in Right Orlandic Operculum|Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.|Baseline||||percent of significant voxels in cluster|||Number
1331307|NCT02080832|Other Pre-specified|fMRI Brain Activation in Right Precentral Gyrus|Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.|Baseline||||percent of significant voxels in cluster|||Number
1331308|NCT02080832|Other Pre-specified|fMRI Brain Activation in Right Inferior Frontal Gyrus|Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.|Baseline||||Percent of significant voxels in cluster|||Number
1331309|NCT02080832|Primary|Cocaine Use/Treatment Effectiveness Score (TES)|Number of benzoylecgonine negative urines divided by the total number of urines collected|8 weeks of treatment||||percentage of negative urines|||Number
1331310|NCT02080819|Primary|Cocaine Treatment Outcome|Treatment effectiveness score based on number of positive urine drug screens|Baseline to 12 weeks||||positive drug screens||Standard Deviation|Mean
1331311|NCT02080780|Primary|Peak Plasma Concentration (Cmax) of 2% Diltiazem|To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.|9 days||||ng / mL||Standard Deviation|Mean
1331312|NCT02080546|Secondary|Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing|a difference between arms in the proportion of patients who have at least one of the following post-operatively: vaginal vault granulation tissue, vaginal cuff separation/dehiscence, or vaginal apex infection|4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination|This secondary objective was not evaluated|||participants||95% Confidence Interval|Number
1331313|NCT02080546|Primary|Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy|"distance in millimeters over which thermal tissue injury extends (henceforth referred to as injury)."|up to 36 months|49 participants were included in the cut/coag arm and 52 participants in the V mode arm. Thermal injury was assessed at the anterior margin in 91 specimens and at the posterior margin in 93 specimens.|||mm|Participants|Full Range|Mean
1339240|NCT01953224|Other Pre-specified|Frequency of App Use Over 12 Weeks|Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app|12 weeks|||||||
1331314|NCT02080507|Secondary|Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score|The Q-Les-SF assesses the degree of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. The minimum raw score is 14, and the maximum score is 70. Higher scores indicate better satisfaction with life domains (physical health, feelings, work, household duties, school/course work, leisure time activities, and social relations).|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1331315|NCT02080507|Primary|Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1331316|NCT02080481|Secondary|Percentage of Time With Perfect Needle Visibility|Percentage of time that perfect needle visibility was visualized on ultrasound.|From start of block procedure until block placement||||percentage of time||Standard Deviation|Mean
1331317|NCT02080481|Secondary|> 1 Block Attempt|Number of block attempts was collected for each patient as > 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it.|from start of block procedure until block placement||||Participants|||Count of Participants
1331318|NCT02080481|Secondary|Block Failure|Number of patients who had block failure|start of surgery until femoral nerve block completion||||Participants|||Count of Participants
1331319|NCT02080481|Primary|Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System||time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery.||||seconds||Inter-Quartile Range|Median
1331320|NCT02080312|Secondary|Extension of Contrast From Perilymph to CSF|The fundus of the internal auditory canal (IAC) was visually inspected to determine if there was conspicuous, subtle, or no enhancement extending in the setting of prior IT contrast injection, indicating permeability of the cochlear modiolus.|24 hours post injection||||participants|||Number
1331321|NCT02080312|Primary|"Cochlear Endolymphatic Hydrops (EH)"|The relative volume of the scala media of the basal turn of the cochlea (non-enhancing endolymph) was visually assessed relative to the scala tympani and scala vestibuli (enhancing perilymph) on delayed post-IT contrast FLAIR MRI sequences. Cases were characterized as: No Cochlear EH (no perceptible distention of the scala media), Cochlear EH (perceptible distention of the scala media), or Absent enhancement (no contrast in the cochlear perilymph)|24 hours post injection||||participants|||Number
1331322|NCT02080312|Primary|"Vestibular Endolymphatic Hydrops (EH)"|The relative volume of the non-enhancing endolymphatic space was visually assessed relative to the enhancing perilymphatic space on delayed post-IT contrast FLAIR MRI sequences and characterized as <34%, 34-50% or >50% of endolymphatic/perilymphatic volume.|24 hours post injection||||participants|||Number
1331323|NCT02080091|Secondary|Retinal Center Subfield Thickness|Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.|24 months|23 Patients received ILUVIEN, one patient was treated bilaterally|||microns|Participants|Standard Deviation|Mean
1331324|NCT02080091|Primary|Number of Patients With Ocular Adverse Events||24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally|||participants|Participants||Number
1331325|NCT02080091|Primary|Visual Acuity|Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.|24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally|||LogMAR|Participants|Standard Error|Mean
1331326|NCT02079909|Secondary|ADCS-ADL|The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.|52 weeks||||units on a scale||Standard Error|Mean
1331327|NCT02079909|Primary|CGIC|The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient’s clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.|52 weeks||||units on a scale||Standard Error|Mean
1331328|NCT02079909|Primary|ADAS-cog|The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).|52 weeks||||units on a scale||Standard Error|Mean
1331329|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurement|Vital signs were oral body temperature, respiration rate, supine blood pressure (after 5 minutes resting), and pulse rate.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the vital sign tests on Day 8 of each treatment period.|||percentage of participants|||Number
1331330|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests|Percentage of participants with markedly abnormal safety laboratory tests (Hematology, Serum Chemistry and Urinalysis) collected throughout the study.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the laboratory tests during treatment.|||percentage of participants|||Number
1331769|NCT02071849|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Error|Mean
1331331|NCT02079844|Secondary|Percentage of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 until Day 63|Safety population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1331332|NCT02079844|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Positive subscale consists of 7 items which assesses the positive symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. General psychopathology subscale consists of 16 items which assesses the general symptoms of schizophrenia with subscale score ranging from 16 to 96, where higher score indicates greater severity. A negative change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||score on a scale||Standard Error|Least Squares Mean
1331333|NCT02079844|Secondary|Change From Baseline in Frontal Theta Power (EEG) During N-Back Working Memory Task|EEG, a test that measures brain electrical activity, was performed during the n-back task. In the n-back task participants are required to monitor a series of letters and report when the current letter matches the letter n integers back, where n=1 (1-back) or n=2 (2-back), the latter requiring a greater working memory resources. The task requires continuous updating of information stores. In the 0-back condition (which does not require manipulation of material in working memory), participants respond to the appearance of a pre-specified letter. The task consists of alternating 30-second (s) blocks of 0-back with 1-back, and 2-back conditions, with letters displayed every 2 s for 1 s within each block. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||μV||Standard Error|Least Squares Mean
1331334|NCT02079844|Secondary|Change From Baseline in High Beta/Low Gamma Power During Resting EEG|Participants are asked to open and close their eyes in 30 second alternating blocks to maintain an approximately constant level of arousal. The eyes closed EEG, a test that measures brain electrical activity, is dominated by alpha (8-14Hz) and the eyes open EEG dominated by beta (14-30Hz eyes open) with the two states analyzed separately to increase sensitivity to drug effects in these bands. Ratio is calculated as High Beta/Low Gamma Power. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||ratio||Standard Error|Least Squares Mean
1331335|NCT02079844|Secondary|Change From Baseline in Amplitude of the C1 Component of the Visual Evoked Potentials at the Midline Occipital Electrode (Oz)|EEG, a test that measures brain electrical activity was used. Participants had a baseline Visual Evoked Potentials (VEP) recording (2 minute checkerboard VEP) followed by a period of high frequency stimulation (2 minutes 9 Hz checkerboard stimulation). The VEP was repeated 2 minutes after the end of high frequency stimulation. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||μV||Standard Error|Least Squares Mean
1331336|NCT02079844|Secondary|Change From Baseline in Mismatch Negativity (MMN) Amplitude at the Midline Frontal Electrode (Fz)|EEG, a test that measures brain electrical activity was performed during the MMN. The MMN is an auditory event related potential that is elicited by any discriminable change in auditory stimulation irrespective of the participant or participant's attention. The response to stimuli is being recorded by EEG electrodes while participants read a book. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||μV||Standard Error|Least Squares Mean
1331337|NCT02079844|Secondary|Change From Baseline in P300 Amplitude at the Midline Parietal Electrode (Pz)|"Brain electrical activity changes were quantified with electroencephalogram (EEG) battery tests. The P300 occurs after the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli. It reflects allocation of attention and activation of immediate memory.~The amplitude of P300 indexes brain actions when the mental representation of the stimulus environment is updated, while its latency indexes stimulus classification speed unrelated to response selection processes. The participants are instructed to push a button when hearing the target stimulus, but not when hearing the standard. They are asked to press the button as fast as possible. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||microvolts (μV)||Standard Error|Least Squares Mean
1331338|NCT02079844|Secondary|Ventral Striatum Activation During the Reward Trials|"BOLD fMRI, a test that measures brain activity, was used during the Reward Task (Monetary Incentive Delay Test). Participants were instructed to respond as quickly as possible to a light-flash on the display screen. The flash was preceded by an arrow icon that informed participants about the consequences of their response to the flash stimulus. Four conditions were included in the paradigm, as follows:~Win condition (arrow up): win 2 pound sterling if the response was sufficiently fast.~Avoidance of loss condition (arrow down: lose 2 pound sterling if the response was too slow.~Verbal control (vertical double arrow): no gain or loss of money.~Passive control condition (horizontal double arrow): No response was required. Each of the above conditions was presented at least 10 times in a random order. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||unitless parameter estimates||Standard Error|Least Squares Mean
1331339|NCT02079844|Secondary|Ventrolateral Prefrontal (VLPF) Cortex and Orbitofrontal (OFX) Cortex Activation During the Shift Trials|BOLD fMRI, a test that measures brain activity, was used during the Shifting Task at VLPF and OFX. Participants worked out which pair in a stimulus set consisting of a face and a building; transparent and overlapping, was the target. 1 pair appeared on the left of the screen, the other on the right. In each trial, participants indicated using a button box which side of the screen they thought the target was located on. Every second response, feedback was presented on the screen for 0.6 seconds, indicating whether or not the stimulus chosen was the target. If both of the last 2 choices were correct, the feedback was the word ‘‘correct’’ in green; otherwise, the feedback was the word ‘‘incorrect’’ in red. After 3 positive feedback events, a change of target occurred. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||unitless parameter estimates||Standard Error|Least Squares Mean
1331340|NCT02079844|Secondary|Change From Baseline in Category Fluency Animal Naming Scores|The Category Fluency test assesses the participant's speed of processing. The test is administered orally, with the participant naming as many animals as he can in 1 minute. The key outcome variable for the test is the total number of correct, valid category words in 60 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||correct words||Standard Error|Least Squares Mean
1331341|NCT02079844|Secondary|Change From Baseline in Brief Assessment of Cognition in Schizophrenia: Symbol-Coding|The Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding assesses the participant's speed of processing. The test is a timed paper-and-pencil test in which the participant uses a key to write digits that correspond to nonsense symbols. The key outcome variable for this task is the total number of correct, valid symbols in 90 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||correct symbols||Standard Error|Least Squares Mean
1331342|NCT02079844|Secondary|Change From Baseline in the Continuous Performance Test (CPT)|The CPT is a computerized test that assesses the participant’s attention and vigilance. The participant was asked to attend to digits flashing on a computer screen and to click the mouse when the same string of digits flashed consecutively. The test consisted of 3 trials: the first contained 2-digit sequences, the second contained 3-digit sequences, and the third contained 4-digit sequences. Scoring was based the number of correct hits. The total score was an average of the 3 trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||correct hits||Standard Error|Least Squares Mean
1331343|NCT02079844|Primary|Dorsolateral Prefrontal Cortex Activation During the Rewarded Delayed Response Working Memory|BOLD Functional magnetic resonance imaging (fMRI) changes in the blood-oxygen-level-dependent (BOLD) - signal, which changes in response to neural activity. Baseline fMRI measurements will be followed by rewarded delayed response Working Memory (WM) task measurements in which participants are required to remember the spatial location of a target stimulus (a dot) relative to a fixation cross. Participants are given feedback indicating success or failure. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||unitless parameter estimates||Standard Error|Least Squares Mean
1331355|NCT02079610|Secondary|Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on HDRS are from from 0 to 50, with higher scores indicating more severe depression. Usual cutoff points are:~0 to 7 – normal /symptom absent 8 to 16 – mild depression 17 to 23 – moderate depression >24 – severe depression"|baseline and 2 weeks|One participant in each group did not complete all study visits|||units on a scale||Standard Deviation|Mean
1331702|NCT02073747|Primary|Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.|We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.|Change in serum lactate from baseline to 1 hour||||mmol/L||95% Confidence Interval|Mean
1331344|NCT02079844|Primary|Change From Baseline in Hopkins Verbal Learning Test (HVLT) Score|The HVLT assesses the participant's verbal learning. The test consists of a list of 12 words from three taxonomic categories which are presented orally, and the participant is asked to recall as many as possible after each of three learning trials. The key outcome variable for this task is the total correct responses in the three learning trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.|||correct responses||Standard Error|Least Squares Mean
1331345|NCT02079844|Primary|Change From Baseline in Spatial Span Test Score|The Spatial Span test assesses the participant’s working memory. During this task, participants are presented with a board containing blue blocks randomly arranged. The rater first taps out a pattern of blocks, beginning with two blocks and increasing with participant proficiency, and the participant is tasked with tapping the same pattern. After discontinuation of this part of the subtest, the participant is then tasked with tapping out the reverse pattern after the rater's demonstration. These patterns also begin with two blocks and increase with participant proficiency. The total score for this subtest ranges from 0 (worst) to 32 (best). A positive change from Baseline indicates improvement. Analysis of Variance (ANOVA) with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.|||score on a scale||Standard Error|Least Squares Mean
1331346|NCT02079805|Secondary|Number of Participants With Treatment-Emergent Adverse Events||Up to Week 12|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||participants|||Number
1331347|NCT02079805|Secondary|Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||μg/mL||Standard Deviation|Mean
1331348|NCT02079805|Secondary|Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in HOMA-β collected at week 12 or final visit relative to baseline was reported. Homeostasis model assessment of beta cell function measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||percent||Standard Deviation|Mean
1331349|NCT02079805|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in the values of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||percent||Standard Deviation|Mean
1331350|NCT02079805|Secondary|Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||µU/mL||Standard Deviation|Mean
1331351|NCT02079805|Secondary|Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||mg/dL||Standard Deviation|Mean
1331352|NCT02079805|Primary|Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)|Change from the start of the treatment period (baseline) at the end of the treatment period (Week 12) was reported. Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405).|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||HOMA-R Score||Standard Deviation|Mean
1331353|NCT02079649|Secondary|Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline].|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.|||hours x units on a scale||Standard Error|Mean
1331354|NCT02079649|Primary|Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline]. Both eyes contributed to the analysis.|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.|||hours x units on a scale||Standard Error|Mean
1339241|NCT01953224|Other Pre-specified|Acceptability|Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability|12 weeks|||||||
1331356|NCT02079610|Secondary|Change From Baseline Beck Depression Inventory at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on BDI are from from 0 to 63, with higher scores indicating more severe depression. Usual cutoff points are:~0 to 13 – normal /symptom absent 14 to 19 – mild depression 20 to 28 – moderate depression >29 – severe depression"|baseline and 2 weeks|One participant in each group did not complete all study visits|||units on a scale||Standard Deviation|Mean
1331357|NCT02079610|Primary|Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are:~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|baseline and 2 weeks|1 participant in each group did not complete all study visits|||units on a scale||Standard Deviation|Mean
1331358|NCT02079532|Secondary|Rheumatoid Factor (RF)|Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||IU/mL||Standard Deviation|Mean
1331359|NCT02079532|Secondary|Erythrocyte Sedimentation Rate (ESR)|Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm/hr||Standard Deviation|Mean
1331360|NCT02079532|Secondary|C-Reactive Protein (CRP)|Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mg/dL||Standard Deviation|Mean
1331361|NCT02079532|Secondary|Patient's Assessment of Pain|Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no pain” and the right-hand (100 mm) as “unbearable pain”.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm||Standard Deviation|Mean
1331362|NCT02079532|Secondary|Patient's Assessment of Disease Activity|Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as “maximum disease activity” (maximum arthritis disease activity).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm||Standard Deviation|Mean
1331363|NCT02079532|Secondary|Physician's Global Assessment of Disease Activity|Physicians assessed the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as “maximum disease activity” (maximum arthritis disease activity).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm||Standard Deviation|Mean
1331364|NCT02079532|Secondary|Tender Joint Count (TJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||tender joints||Standard Deviation|Mean
1331365|NCT02079532|Secondary|Swollen Joint Count (SJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||swollen joints||Standard Deviation|Mean
1331366|NCT02079532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit.|Weeks 8, 16, and 24|ITT population|||percentage of participants|||Number
1331367|NCT02079532|Secondary|SF-36 Domain Scores|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
1331368|NCT02079532|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
1331442|NCT02076321|Primary|Compare the Time to Union of Fractures and Osteotomies in Skeletally Immature Patients Administered NSAIDs for Pain Control, Versus Those Administered Acetaminophen for Pain Control.||The subject will be enrolled/assessed up to 6 months post-injury/osteotomy.||||Days||Full Range|Mean
1331443|NCT02076243|Secondary|Safety and Tolerability|number of participants with adverse events as a measure of safety and tolerability|up to 5 years||||Participants|||Count of Participants
1331369|NCT02079532|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
1331370|NCT02079532|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
1331371|NCT02079532|Secondary|Percentage of Participants Achieving a Response By EULAR Category|Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score of >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Weeks 8, 16, and 24|ITT population|||percentage of participants|||Number
1331372|NCT02079532|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24|Percentage of participants with remission defined as DAS28 <2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population|||percentage of participants|||Number
1331373|NCT02079532|Secondary|Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24|Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).|Week 24|ITT population|||percentage of participants|||Number
1331374|NCT02079532|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate|The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of >1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1.|Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit|||percentage of participants|||Number
1331375|NCT02079532|Secondary|DAS28 Score|The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient’s Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening and Weeks 8, 16, and 24|ITT population; n (number) = number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
1331376|NCT02079532|Primary|Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient’s Global Assessment of Disease Activity (participant-ated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|Intent to Treat (ITT) population: all participants who signed informed consent, received at least 1 dose of study drug, and where DAS28 was measured at least once under study medication (Weeks 8, 16, or 24 or unscheduled or withdrawal visit up to Week 24); those with no RA or no DAS28 score at screening were excluded, regardless if treated or not.|||scores on a scale||Standard Deviation|Mean
1331377|NCT02079519|Secondary|Overall Survival|Overall survival was defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 1 year)|||||||
1331378|NCT02079519|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of study drug to disease progression or death due to progression.|Baseline to the end of the study (up to 1 year)|||||||
1331379|NCT02079519|Primary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of the original monoclonal protein from the blood and urine on at least 2 determinations 6 weeks apart; < 5% plasma cells in the bone marrow on at least 2 determinations 6 weeks apart; if a skeletal survey is available, no increase in the size or number of lytic bone lesions; and the disappearance of soft tissue plasmacytomas for at least 6 weeks. A partial response was defined as a ≥ 50% reduction of monoclonal protein in the blood on at least 2 determinations 6 weeks apart; if present, reduction in 24-hour urinary light chain excretion by either ≥ 90% or to < 200 mg for at least 2 determinations 6 weeks apart; ≥ 50% reduction in the size of tissue plasmacytomas for at least 6 weeks; and if a skeletal survey is available, no increase in the size or number of lytic bone lesions.|Baseline to the end of the study (up to 1 year)|Intent-to-treat population: All participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1340181|NCT01940484|Primary|Mean Hemoglobin Value at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
1331380|NCT02079311|Primary|The Difference in Core Body Temperature in the Two Treatment Groups.|Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.|Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.||||degree celsius||Standard Deviation|Mean
1331381|NCT02079246|Secondary|Change in Cognitive Aspects of Mental Function|Change from Baseline III to Week 52 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline III (start of OLEX-MEM, Week 28) to Week 52|All patients who took at least one dose of IMP or memantine in the OLEX-MEM.|||units on a scale||Standard Error|Mean
1331382|NCT02079246|Secondary|Change in Cognitive Aspects of Mental Function|Change from Baseline II to Week 28 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
1331383|NCT02079246|Secondary|Change in Behavioural Disturbance|Change from Baseline II to Week 28 in Neuropsychiatric Inventory (NPI) total score. The NPI is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
1331384|NCT02079246|Secondary|Change in Daily Functioning|Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The ADCS-ADL23 is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
1331385|NCT02079246|Secondary|Clinical Global Impression Score|Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28. The ADCS-CGIC is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).|Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
1331386|NCT02079246|Secondary|Change in Cognition|Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score. The ADAS-cog is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
1331387|NCT02079246|Primary|Number of TEAEs in the OLEX-MEM|A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).|From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)|All patients who took at least one dose of IMP or memantine in the OLEX-MEM.|||TEAEs|||Number
1331388|NCT02079246|Primary|Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX|A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.|Baseline II (start of OLEX, week 0) to end of OLEX (week 28)|All patients who took at least one dose of IMP in the OLEX.|||TEAEs|||Number
1331389|NCT02078492|Secondary|Adverse Effect of Headache|The number of study patients who reported headache after administration of medication|120 minutes||||Participants|||Count of Participants
1331390|NCT02078492|Secondary|Adverse Effect of Nausea|The number of study patients who reported nausea after administration of medication|120 minutes||||Participants|||Count of Participants
1331391|NCT02078492|Secondary|Adverse Effect of Dizziness|the number of study patients who reported having dizziness after administration of medication.|120 minutes||||Participants|||Count of Participants
1331392|NCT02078492|Primary|Pain Score at 30 Minutes|Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.|30 minutes||||pain score||Standard Deviation|Mean
1331393|NCT02078193|Other Pre-specified|Number of Participants With Chronic Kidney Rejection|Incidence of chronic kidney rejection|One year||||participants|||Number
1331394|NCT02078193|Secondary|Safety|Incidence of infections|one year|Number of participants with infections|||Participant|||Number
1331395|NCT02078193|Primary|Change of Donor Specific Antibodies (DSA)|DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.|one year||||percent change in DSAs||Standard Deviation|Mean
1331444|NCT02076243|Secondary|Treatment Response|correlation of response to first line treatment with Nab-Paclitaxel with SPARC expression, with target lesions measured at the longest diameter of each non-lymph node lesion and the short axis for target lymph nodes|at week 8 post treatment|study terminated, results not collected||||||
1331396|NCT02078180|Secondary|Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage|Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the maximum concentration. The maximum concentration depends on the rate of drug release and so looking at this value can help us compare differences between formulation.|4 days||||nanogram/milliliter||Standard Error|Mean
1331397|NCT02078180|Primary|Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage|Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).|4 days||||h*nanogram/milliliter||Standard Deviation|Mean
1331398|NCT02077374|Secondary|Levels of flCK18/M65|Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Full Range|Median
1331399|NCT02077374|Secondary|Levels of Caspase 3/7 RLU|Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||RLU||Full Range|Median
1331400|NCT02077374|Secondary|Levels of cCK18/M30|Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Full Range|Median
1331401|NCT02077374|Secondary|Change in Aspartate Aminotransferase (AST)|Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo.|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Full Range|Median
1331402|NCT02077374|Primary|Relative Percent Change in Alanine Aminotransferase (ALT)|Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Baseline to Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||Relative percent change||Standard Deviation|Mean
1331403|NCT02077374|Primary|Change in Alanine Aminotransferase (ALT)|Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Standard Deviation|Mean
1331404|NCT02077140|Other Pre-specified|Subject's Satisfaction With Study Treatment (Exploratory Analysis)|Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent|up to 72hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||Participants|||Count of Participants
1331405|NCT02077140|Other Pre-specified|Time to First Use of Opioid Analgesia (Exploratory Analysis)||up to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||hours||95% Confidence Interval|Median
1331406|NCT02077140|Other Pre-specified|Total Use of Opioid Analgesia (Exploratory Analysis).||over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||morphine mg equivalent||Standard Deviation|Mean
1331407|NCT02077140|Other Pre-specified|Summed Pain Intensity Scores (Exploratory Analysis)|The theoretical range for SPI-24, SPI-48, SPI-72, and SPI-96 is 0 to 230, 0-470, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).|over 1 to 24hr, 1 to 48 hrs, 1 to 72hrs, and 1 to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||units on a scale||Standard Deviation|Mean
1331408|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Phase Rate Constant (λz)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||/hr||Standard Deviation|Mean
1331409|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Plasma Half-life (t½)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||hrs||Standard Deviation|Mean
1331852|NCT02070640|Secondary|Incidence of Anatomic Identification With NIRF-C|Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.|Intraoperative||||percentage of biliary anatomy observatio|||Number
1331410|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Lag Time Before First Measurable Drug Concentration (Tlag)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||hrs||Full Range|Median
1331411|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Time to Maximum Plasma Concentration Observed (Tmax)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||hrs||Full Range|Median
1331412|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Maximum Observed Plasma Concentration (Cmax)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||pg/mL||Standard Deviation|Mean
1331413|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||h*pg/mL||Standard Deviation|Mean
1331414|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||h*pg/mL||Standard Deviation|Mean
1331415|NCT02077140|Secondary|Subject's Satisfaction With Study Treatment|Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent|up to 72hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||Participants|||Count of Participants
1331416|NCT02077140|Secondary|Time to First Use of Opioid Analgesia||up to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||hours||95% Confidence Interval|Median
1331417|NCT02077140|Secondary|Total Use of Opioid Analgesia Over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs.|Total use of opioid analgesia over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs. The analgesia administered was converted to a morphine equivalent by using a standard conversion table.|over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||morphine mg equivalent||Standard Deviation|Mean
1331418|NCT02077140|Secondary|Summed Pain Intensity Scores Over 1- 24hrs (SPI-24), 1- 72hrs (SPI-72) and 1- 96hrs (SPI-96)|The theoretical range for SPI-24, SPI-72, and SPI-96 is 0 to 230, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).|over 1 to 24hrs, 1 to 72hrs, and 1 to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
1331419|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Windowed Worst Observation Carried Forward (WOCF)|Similar to SPI-48, the theoretical range for this WOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to each instance of rescue medication is carried forward through for a window based on the approximate half-life of the drug, replacing the raw NRS scores post-rescue for each patient until the end of the pharmacological activity window, at which point calculations revert to raw NRS as applicable. Note that WOCF SPI-48 may include multiple adjustment windows for each patient, depending on the number or rescue events and the active life of the medication selected.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
1331420|NCT02077140|Primary|Integrated Summed Pain Intensity Over 1- 48hrs (SPI-48) and Total Opioid Intake in First 48hrs --Sensitivity Analysis Using Silverman Method|This sensitivity analysis is an integrated assessment of summed pain intensity over 1 to 48hrs (SPI-48) and total opioid intake (ME0-48) in first 48hrs. Briefly, subjects were ranked according to SPI-48 regardless of the treatment received (including Standard of Care, SOC). The mean of all the ranks for this variable was calculated. Then, the percent difference for each individual rank from the pooled mean rank was computed. This process was repeated for total opioid intake in the first 48hrs (ME0-48). The integrated endpoint for each subject was the sum of the rank order percent differences for SPI-48 and ME0-48. The theoretical minimum and maximum on the integrated endpoint are -197% and +197% in this study. Lower scores are better, indicative of less pain and/or less opioid intake.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||percent difference||Standard Deviation|Mean
1331421|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Last Observation Carried Forward (LOCF)|Similar to SPI-48, the theoretical range for this LOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical to SPI-48 in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to rescue is carried forward through 48 hours, replacing the raw NRS scores post-rescue for each patient as applicable.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
1331422|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48) From Cohort 1 to 3|Summed pain intensity is a time-weighted average pain score in numeric rating scale (NRS) over 1 to 48hrs (SPI-48). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours). The theoretical range for SPI-48 is 0 to 470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Time 0 was defined as the time the capsule was closed.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
1331423|NCT02076919|Secondary|Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.|||mmHg||Standard Error|Least Squares Mean
1331424|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.|||mmHg||Standard Error|Least Squares Mean
1331425|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.|||mmHg||Standard Error|Least Squares Mean
1331426|NCT02076919|Secondary|Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.|||mmHg||Standard Error|Least Squares Mean
1331427|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.|||mmHg||Standard Error|Least Squares Mean
1331428|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part 2|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.|||participants|||Number
1331445|NCT02076243|Secondary|Prevalence of SPARC Expression|prevalence of SPARC expression in advanced squamous cell cancer of the skin. The tumor specimen used to determine SPARC expression wll be obtained from a biopsy previously performed as standard of care (such as to establish the diagnosis).|at baseline|study terminated, results not collected||||||
1331429|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part I|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.|||participants|||Number
1331430|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.|||mmHg||Standard Error|Least Squares Mean
1331431|NCT02076919|Secondary|The Terminal Elimination Half-life [Time] (T1/2), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||hour||Standard Deviation|Mean
1331432|NCT02076919|Secondary|The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||ng*h/mL||Standard Deviation|Mean
1331433|NCT02076919|Secondary|The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||hour||Standard Deviation|Mean
1331434|NCT02076919|Secondary|The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||ng/mL||Standard Deviation|Mean
1331435|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.|||participants|||Number
1331436|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.|||participants|||Number
1331437|NCT02076776|Other Pre-specified|The Stroke Impact Scale (SIS)|This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.|Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)||||units on a scale||Standard Deviation|Mean
1331438|NCT02076776|Secondary|The Fugl-Meyer Assessment (FMA)|This is a 33 item assessment of post-stroke UE impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.|Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)||||units on a scale||Standard Deviation|Mean
1331439|NCT02076776|Primary|Wolf Motor Function Test (WMFT)|This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.|Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)||||units on a scale||Standard Deviation|Mean
1331440|NCT02076334|Secondary|Creatine Kinase||baseline, 24 hrs and 48 hrs post||||u/L||Standard Error|Mean
1331441|NCT02076334|Primary|Maximal Voluntary Contraction (MVC)||up to 72 hours||||Newton-meters||Standard Deviation|Mean
1331448|NCT02076178|Secondary|Number of Participants Who Experienced Maximum Clinical Chemistry Including Liver Chemistry and Hematology Toxicities in the Oral Phase by Grades|The severity of clinical chemistry including liver chemistry and hematology toxicities was graded according to the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. Data for maximum clinical chemistry and hematology toxicities for oral phase (Day 1 upto Week 4) by grades have been presented.|Up to Week 4|Safety population.|||Participants|||Count of Participants
1331449|NCT02076178|Secondary|Number of Participants Who Received Concurrent Medication in Overall Study Duration|The concurrent medications that were consumed by participants during the injection phase were of the class nervous system, musculo-skeletal system, genito-urinary systems and sex hormones, various, respiratory system, dermatologicals, alimentary tract and metabolism, anti-infectives for systemic use, sensory organs, systemic hormonal preparations excluding sex hormones, blood and blood forming organs, cardiovascular system, anti-neoplastic and immunomodulating agents, anti-parasitic products, insecticides and repellents . The participants who took medication from any of the above class of during the during the overall study duration injection phase (Day 1 until Week 41) have been presented.|Up to Week 41|The Randomized Population comprised of all participants who met study criteria were randomly assigned to treatment in the study with the exception of any participants with documented evidence of not having consumed any amount of study medication.|||Participants|||Count of Participants
1331450|NCT02076178|Secondary|Number of Participants With AE, Grade 2-4 AE and Serious Adverse Events (SAE) in the Oral Phase|Clinical AE were graded using the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The grades were: 1 (mild)=Symptoms causing no or minimal interference with usual social and functional activities; 2 (moderate)= Symptoms causing greater than minimal interference with usual social and functional activities; 3 (severe)= Symptoms causing inability to perform usual social and functional activities; 4 (potentially life threatening): Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data has been presented for any Grade 2 or higher event in the injection phase for injection phase (Week 5- Week 41).|Up to Week 4|Safety population.|||Participants|||Count of Participants
1331451|NCT02076178|Secondary|Number of Participants With Severity of ISRs and ISR Symptoms for Injection Phase Defined by Grades and Needle Length|Acceptability of cabetogravir injections was assessed number of participants who had severe ISRs and ISR symptom. ISR examination for severity included an assessment of pain, pruritis, warm to touch, bruising, discoloration, erythema, swelling, induration and bump events. Common ISR Symptoms for Injection Phase included pain, erythema, nodules and any other ISRs with greater or equal to five participants. Data has been presented for the injection phase (W5-W41) by grades and needle length.|Up to Week 41|Safety injection population.|||Participants|||Count of Participants
1331452|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Tmax and t½ by Demographic Factor BMI and Needle Length in the Injection Phase|The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for tmax and t½ by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI). Assessments was also performed for tmax and t½ by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed.|||Days||Standard Deviation|Mean
1331453|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Ctau and Cmax by Demographic Factor BMI and Needle Length in the Injection Phase|"The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for Ctau and Cmax by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI.~). Assessments was also performed for Ctau and Cmax by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square."|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed.|||micrograms per milliter||Geometric Coefficient of Variation|Geometric Mean
1331454|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for AUC(0-tau) by Demographic Factor Body Mass Index (BMI) and Needle Length in the Injection Phase|The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for AUC (0-tau) by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI). Assessments was also performed for AUC (0-tau) by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed.|||hour*microgram per milliter||Geometric Coefficient of Variation|Geometric Mean
1331455|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Time to Maximum Observed Concentration (Tmax), Apparent Terminal Phase Half-life for (t½) in the Injection Phase|Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for tmax defined as the time to the maximum observed plasma concentration and t½ defined as the time taken for the concentration of drug in the blood to decrease by half of the original amount.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time points were analyzed.|||days||Standard Deviation|Mean
1331456|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Concentration at the End of the Dosing Interval (Ctau) and Maximum Observed Concentration (Cmax) in the Injection Phase|Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for Ctau defined as the concentration at the end of the dosing interval and Cmax defined as the maximum observed plasma concentration.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time points were analyzed.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1331457|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Area Under the Plasma Concentration-time Curve Over the Dosing Interval [AUC(0-tau)] in the Injection Phase|Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for AUC(0-tau) a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (i.e.12 hours).|Up to Week 41|The pharmacokinetic parameter population comprised of all participants who underwent plasma pharmacokinetic sampling and have evaluable cabotegravir parameters estimated. Only those participants available at the specified time points were analyzed.|||hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1331458|NCT02076178|Primary|Number of Participant With ISR for the Injection Phase Defined by Maximum Grades|Common ISR included pain, erythema, nodules and any other ISR with greater or equal to 5 participants. The number of participants who experienced pain events by needle length, swelling events by needle length, bump events by needle length for injection phase by maximum grades have been presented for the injection phase (Week 5-Week 41).|Up to Week 41|Safety Injection population.|||Participants|||Count of Participants
1331459|NCT02076178|Primary|Change From Baseline in Vital Sign Assessment for Heart Rate (HR) in the Injection Phase|Vital signs measurements were performed for HR following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41.|Baseline (Week 5) to Week 41|Safety population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1331460|NCT02076178|Primary|Change From Baseline in Vital Sign Assessment for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Injection Phase|Vital signs measurements were performed for SBP and DBP following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41.|Baseline (Week 5) to Week 41|Safety population. Only those participants available at the specified time points were analyzed.|||millimeters of mercury||Standard Deviation|Mean
1331461|NCT02076178|Primary|Number of Participants Who Had Abnormal Electrocardiogram (ECG) Findings in the Injection Phase|Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant following 5 minutes of rest in a semi-supine position. ECGs were performed at Week 5, Week 17, Week 29 and Week 41 in the injection phase (Week 5-Week 41). ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto Week 41 have been presented. There were no A-CS findings for ECG in the injection phase.|Up to Week 41|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1331462|NCT02076178|Primary|Number of Participants Who Experienced Grade 2 or Higher Laboratory Results in the Injection Phase|The severity of laboratory results was graded according to the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. Data for Number of participants who experienced grade 2 or higher laboratory results in the injection phase (Week 5-Week 14) have been presented.|Up to Week 41|Safety Injection population.|||Participants|||Count of Participants
1331463|NCT02076178|Primary|Number of Participants Who Recieved Injection Site Reaction (ISR) Related Concomitant Medication in the Injection Phase|The concurrent medications that were consumed by participants during the injection phase were of the class nervous system, musculo-skeletal system, genito urinary systems and sex hormones, various, respiratory system, dermatologicals, alimentary tract and metabolism, sensory organs, systemic hormonal preparations, excluding sex hormones, blood and blood forming organs, cardiovascular system. The participants who took medication from any of the above class of during the injection phase (Week 5-Week 41) have been presented.|Up to Week 41|The randomized population was defined as all participants who met the study criteria and were randomly assigned to treatment in the study.|||Participants|||Count of Participants
1331487|NCT02075840|Secondary|Area Under The Concentration-Time Curve (AUC) of Alectinib||Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331729|NCT02072980|Secondary|Average Coefficient of Friction at 15 Minutes|Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 15 minutes|This analysis population includes all participants who completed the study.|||unitless||Standard Deviation|Mean
1331464|NCT02076178|Primary|Number of Participants With Any Grade 2 or Higher Event in the Injection Phase|Clinical adverse event (AE) were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The grades were: 1 (mild)=Symptoms causing no or minimal interference with usual social and functional activities; 2 (moderate)= Symptoms causing greater than minimal interference with usual social and functional activities; 3 (severe)= Symptoms causing inability to perform usual social and functional activities; 4 (potentially life threatening): Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data has been presented for any Grade 2 or higher event in the injection phase for injection phase (Week 5- Week 41).|Up to Week 41|Safety Injection population was defined as all participants enrolled in the study who received at least one injection of study medication.|||Participants|||Count of Participants
1331465|NCT02076009|Secondary|Duration of Response (DOR)|DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to the date of first documented evidence of PD until 3 years|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.|||months||95% Confidence Interval|Median
1331466|NCT02076009|Secondary|Time to Response|Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.|From randomization up to first documented CR or PR until 3 years|Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.|||months||95% Confidence Interval|Median
1331467|NCT02076009|Secondary|Overall Survival (OS)|Overall survival was measured from the date of randomization to the date of the participant's death.|Up to approximately 5 years (anticipated) after the last participant is randomized|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.|||months||95% Confidence Interval|Median
1331468|NCT02076009|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.|||percentage of participants|||Number
1331469|NCT02076009|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^- 4 threshold.|From randomization to the date of first documented evidence of PD until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.|||percentage of participants|||Number
1331470|NCT02076009|Secondary|Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better|VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1331488|NCT02075840|Secondary|Percentage of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm|Safety (SAF) population included all participants who received at least one dose of any study drug.|||Percentage of Participants|||Number
1331761|NCT02071849|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min||Standard Deviation|Mean
1331471|NCT02076009|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From randomization to disease progression until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.|||months||95% Confidence Interval|Median
1331472|NCT02076009|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to either disease progression or death whichever occurs first until 3 years|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.|||months||95% Confidence Interval|Median
1331473|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
1331474|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
1331475|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
1331476|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
1331477|NCT02075840|Secondary|Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score|The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
1331543|NCT02075463|Secondary|Change From Baseline in Hematocrit at Week 16|Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||Fraction of 1|||Number
1331478|NCT02075840|Secondary|Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1331479|NCT02075840|Secondary|Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1331480|NCT02075840|Secondary|Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)|The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1331481|NCT02075840|Secondary|Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)|The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1331482|NCT02075840|Secondary|Tmax of Alectinib Metabolite||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hours||Full Range|Median
1331483|NCT02075840|Secondary|Cmax of Alectinib Metabolite||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1331484|NCT02075840|Secondary|AUC of Alectinib Metabolite||Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331485|NCT02075840|Secondary|Time to Reach Cmax (Tmax) of Alectinib||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hours||Full Range|Median
1331486|NCT02075840|Secondary|Maximum Concentration (Cmax) of Alectinib||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1331544|NCT02075463|Secondary|Mean Corpuscular Hemoglobin (MCH) at Week 16|Data has been presented for only those participants who were available at indicated time points.|Week 16|Safety population|||pg|||Number
1331489|NCT02075840|Secondary|CNS DOR IRC-assessed According to RECIST v1.1 Criteria|CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.|First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.|||months||95% Confidence Interval|Median
1331490|NCT02075840|Secondary|Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria|CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure (number of participants with measurable/non-measurable CNS lesions at baseline).|||Percentage of Participants||95% Confidence Interval|Number
1331491|NCT02075840|Secondary|Percentage of Participants With OS Event|Overall survival (OS) was defined as the time from randomization to death from any cause.|From randomization until death (up to 43 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1331492|NCT02075840|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from randomization to death from any cause.|From randomization until death (up to 43 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1331493|NCT02075840|Secondary|Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators|DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.|First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.|||Months||95% Confidence Interval|Median
1331494|NCT02075840|Secondary|Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria|ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
1331495|NCT02075840|Secondary|Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria|CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.|Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1331496|NCT02075840|Secondary|Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria|CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.|Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1331497|NCT02075840|Secondary|Percentage of Participants With PFS Event by IRC|PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1331498|NCT02075840|Secondary|PFS Independent Review Committee (IRC)-Assessed|PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1331545|NCT02075463|Secondary|Mean Corpuscular Volume (MCV) at Week 16|Data has been presented for only those participants who were available at indicated time points.|Week 16|Safety population|||Femtoliter (fL)|||Number
1331499|NCT02075840|Primary|Percentage of Participants With PFS Event by Investigator Assessment|PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1331500|NCT02075840|Primary|Progression-Free Survival (PFS) by Investigator Assessment|PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1331501|NCT02075658|Secondary|Improvement in Cardiac Output With the AirSeal Device.|"Assuming cardiac output of approximately 5.0 L/min with the conventional device, we will have 96% power to detect as significant an improvement in cardiac output to 5.5 L/min using a two-group Satterwaite t-test and assuming variance of 0.25.~Cardiac out put is defined by the volume of blood pumped by the heart in a given amount of time."|Day 1 (Day of Procedure)||||volume per minute||Standard Deviation|Mean
1331502|NCT02075658|Primary|AirSeal Reduction in the Variance of Intra-abdominal Pressure|Our primary aim is to show reduction in the variance of intra-abdominal pressure throughout the operative procedure when using the AirSeal device compared to a conventional insufflator. Based on preliminary data, we assume pressures maintained at a mean of 15 through out surgery for both devices and a variance of 3.6 with the conventional insufflator.|Day 1 (Day of Procedure)||||mmHg||Standard Deviation|Mean
1331503|NCT02075632|Secondary|Number of Days of Use|The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.|Day 1-Day 14|A subject was evaluable for summaries of number of days of use, if he or she used the study medication at least once and provided use information at Visit 2. Data for 4 subjects was not available for this analysis.|||Days||Standard Deviation|Mean
1331504|NCT02075632|Secondary|Number of Times Per Day Participants Used the Product|The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects.|Day1-Day14|A subject was evaluable for average number of applications per day and maximum number of applications per day if he or she used the study medication at least once and provided use information at Visit 2. Data for four subjects was not available for this analysis.|||Applications||Standard Deviation|Mean
1331505|NCT02075632|Primary|Number of Participants With Incorrect Duration of Use of the Medication|Incorrect duration of use was defined as the use of study medication for more than 7 consecutive days and/or more than three times in a day. Participants were asked the reasons of doing so and they were allowed to select multiple reasons also, if applicable.|Day1-Day 14|A participant was evaluable for analysis of the rate of incorrect use if he or she used the study medication at least once and provided use information at least 8 days after the enrollment visit.|||Participants|||Number
1331506|NCT02075541|Secondary|Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.|Frequency of specific CD8+ T-cells were measured by flow cytometry ICS expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L).The frequency of specific CD8+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.|At Day 0, Day 90, Day 270 and at Day 450.|Analysis was performed on a sub-cohort of participants from the ATP cohort for Immunogenicity, including approximately 40 subjects (20/each group), for which an additional blood sample was taken at the specified time points. The analysis was only performed on those subjects with available results for the analyzed outcome variable.|||CD8+ T-cells/ million cells||Standard Deviation|Mean
1331507|NCT02075541|Secondary|Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.|Frequency of specific CD4+ T-cells were measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers [such as Interleukin-2 (IL-2), IL-13, IL-17, Interferon-γ (IFN-γ), Tumor Necrosis Factor-α (TNF-α) and Cluster of Differentiation 40 Ligand (CD40L)].The frequency of specific CD4+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.|At Day 0, Day 90, Day 270 and at Day 450.|Analysis was performed on a sub-cohort of participants from the ATP cohort for Immunogenicity, including approximately 40 subjects (20/each group), for which an additional blood sample was taken at the specified time points. The analysis was only performed on those subjects with available results for the analyzed outcome variable.|||CD4+ T-cells/ million cells||Standard Deviation|Mean
1331508|NCT02075541|Secondary|Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens.|Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 7 EL.U/mL for anti-PilA.|At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.|Analysis was performed on the ATP cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.|||El.U/mL||95% Confidence Interval|Geometric Mean
1331509|NCT02075541|Secondary|Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens.|Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 8 EL.U/mL for anti-PE.|At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450|Analysis was performed on the ATP cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1331510|NCT02075541|Secondary|Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens.|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay was 153 EL.U/mL for anti-PD.|At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.|Analysis was performed on the According to Protocol (ATP) cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1331511|NCT02075541|Primary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.|From first vaccination (Day 0) up to study conclusion (Day 450).|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331512|NCT02075541|Primary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination (Day 0) up to study conclusion (Day 450).|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331513|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 450.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331514|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 270.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331515|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 90.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331516|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 67.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331517|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 60.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331518|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 30.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331519|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 7.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331546|NCT02075463|Secondary|Reticulocyte Hgb Content (CHr) at Week 16|Data has been presented for only those participants who were available at indicated timepoints|Week 16|Safety population consisted of all participants who received at least one dose of study drug|||Picogram (pg)|||Number
1332202|NCT02061969|Secondary|Number of Participants With Acute Complications|Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).|over 6 months||||Participants|||Count of Participants
1331520|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 0.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331521|NCT02075541|Primary|Number of Subjects With Any Unsolicited AEs|Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 30-day follow-up period (from Day 60 to Day 89) following the second dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331522|NCT02075541|Primary|Number of Subjects With Any Unsolicited AEs.|Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 30-day follow-up period (from Day 0 to Day 29) following the first dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331523|NCT02075541|Primary|Number of Subjects With Any Solicited General AEs|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever (defined as oral temperature equal to or above 37.5 °C). Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 60 to Day 66) following the second dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331524|NCT02075541|Primary|Number of Subjects With Any Solicited General AEs.|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 0 to Day 6) following the first dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331525|NCT02075541|Primary|Number of Subjects With Any Solicited Local AEs.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 60 to Day 66) after second dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331526|NCT02075541|Primary|Number of Subjects With Any Solicited Local Adverse Events (AEs).|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 0 to Day 6) after first dose.|Analysis was performed on the Total Vaccinated Cohort (TVC) that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
1331527|NCT02075515|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Subjects|||Number
1331528|NCT02075515|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Subjects|||Number
1331529|NCT02075515|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Subjects|||Number
1331530|NCT02075515|Secondary|Number of Days With Any Solicited General Symptoms|The number of days with any general symptoms reported during the solicited post-vaccination period.|During the 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
1332203|NCT02061969|Secondary|Changes in Cognitive Function|Data on changes in cognitive function were not collected|over 6 months|Data were not collected||||||
1331531|NCT02075515|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature= temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptom sheets filled in.|||Subjects|||Number
1331532|NCT02075515|Secondary|Number of Days With Any Solicited Local Symptoms|The number of days with any local symptoms reported during the solicited post-vaccination period.|During the 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
1331533|NCT02075515|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities.|Within 7 days (Days 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptoms sheet filled in.|||Subjects|||Number
1331534|NCT02075515|Secondary|Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA|"Vaccine response was defined as:~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
1331535|NCT02075515|Secondary|Anti-gE Humoral Immunogenicity|Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||mIU/mL||95% Confidence Interval|Geometric Mean
1331536|NCT02075515|Primary|Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value|Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).|At Month 3|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
1331537|NCT02075463|Secondary|Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points|Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose [PrD]), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour [hr] post-dose [PoD), and at W12 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.|Day 1, Week 4 and Week 12|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
1331538|NCT02075463|Secondary|Final Dose of GSK1278863|For the first 4 weeks, subjects received 12mg QD of GSK1278863 with dose decrease permitted at Week 2. After 4 weeks of treatment with GSK1278863, need for dose adjustment was evaluated at visits 4, 8 and 12, to maintain hemoglobin within the target range. Target range was defined as: Hgb Criteria of 10.0 to 11.5 g/dL. Data has been presented for only those participants who were available at indicated time points.|Up to 16 Weeks|ITT population|||mg|||Number
1331539|NCT02075463|Secondary|Maximum Observed Change From Baseline in Erythropoietin (EPO)|Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was reported. Baseline value for EPO is the last pre-dose value on Day 1. Change from baseline is calculated as the maximum observed value minus the baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) to Week 16|ITT population|||international units(IU)/Liter (L)||Standard Deviation|Mean
1331540|NCT02075463|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF in the subjects was reported. Baseline value for VEGF is the last pre-dose value on Day 1. Percent change was calculated as 100 multiplied by exponential (log observed maximum value minus log Baseline value) minus 1. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) to Week 16|ITT population|||Percent change||95% Confidence Interval|Geometric Mean
1331541|NCT02075463|Secondary|Change From Baseline in Reticulocyte Number at Week 16|Baseline value for reticulocyte number is the pre-dose value on Day 1. Change from Baseline in reticulocyte number was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||10^12/L|||Number
1331542|NCT02075463|Secondary|Change From Baseline in Red Blood Cell (RBC) at Week 16|Baseline value for RBC (or erythrocytes) is the last pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points|Baseline (Day 1) and Week 16|ITT population|||10^12/L|||Number
1331762|NCT02071849|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||percentage of blood volume||Standard Deviation|Mean
1331547|NCT02075463|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the last pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||µmol/ L|||Number
1331548|NCT02075463|Secondary|Change From Baseline in Total Iron at Week 16|Baseline value for total iron is the last pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||Micromoles (µmol)/L|||Number
1331549|NCT02075463|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 16|Transferrin saturation is measured in percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change is 100 times [exponential (log Week 16 value minus log Baseline value) -1]. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Percent change in transferrin||95% Confidence Interval|Geometric Mean
1331550|NCT02075463|Secondary|Change From Baseline in Transferrin at Week 16|Baseline value for transferrin is the last pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Percent change||Standard Deviation|Mean
1331551|NCT02075463|Secondary|Change From Baseline in Ferritin at Week 16|Baseline value for ferritin is the last pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Micrograms/Liter||Standard Deviation|Mean
1331552|NCT02075463|Secondary|Percent Change From Baseline in Hepcidin at Week 16|Hepcidin is a regulator of iron metabolism. Baseline value for hepcidin is the pre-dose value on Day 1. Percent change was calculated as 100 multiplied by [exponential (log Week 16 value - log Baseline value) minus 1]. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Percent change in hepcidin||95% Confidence Interval|Geometric Mean
1331553|NCT02075463|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The number of participants who reached the Hgb stopping criteria of Hgb concentration <7.5 g/dL from baseline to Week 16 were presented. Participants who were available at the indicated time point were analyzed.|Up to Week 16|ITT population|||Participants|||Number
1331554|NCT02075463|Secondary|Number of Participants With Hgb in the Target Range at Week 16|The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 16 were analyzed. Participants who were available at the indicated time point were analyzed.|Week 16|ITT population|||Participants|||Number
1331555|NCT02075463|Secondary|Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16|Number of participants achieving at least 1 g/dL increase in Hgb from baseline at Week 16 were presented. Participants who were available at the indicated time point were analyzed.|Baseline and Week 16|ITT population.|||Participants|||Number
1331556|NCT02075463|Secondary|Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point|The percentage of time in Hgb levels were in target range (10.0 to 11.5 g/dL) between Weeks 12 and 16 for a participant was calculated by adding the total number of days that Hgb is within target range while on treatment during Weeks 12 to 16 and dividing by the total number of days the participant remained on treatment during Weeks 12 to 16 (using Rosendaal linear interpolation method). Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated. Participants who were available at the indicated time point were analyzed.|Week 12 to Week 16|ITT population.|||Percentage of days||Standard Deviation|Mean
1331557|NCT02075463|Secondary|Change From Baseline in Hgb Levels at Week 16|Hgb values measured at Week 16 are presented. Change from baseline was calculated as Week 16 minus baseline value . Participants who were available at the indicated time point were analyzed.|Week 16|ITT population.|||g/dL||Standard Deviation|Mean
1331558|NCT02075463|Primary|Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16|Percentage of participants with increased Hgb >=1 g/dL (if baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if baseline Hgb is 9.5-<10 g/dL), or within the target range and not dropped by >0.5 g/dL (if baseline Hgb is >= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed|Week 16|ITT population: participants who received at least one dose of drug, have a baseline Hgb and at least one corresponding on treatment Hgb assessment.|||Percentage of participants||95% Confidence Interval|Number
1331559|NCT02075411|Other Pre-specified|Failure of Nerve Block Procedures|We will determine the proportion of failure of the nerve block procedures as assessed by absence of a sensory block in the distribution of the femoral or sciatic nerves. The analysis will be of the numerical rating scale (NRS) scores immediately on arrival (baseline) in the recovery room and then every 6 hours over the first 72 hours post-op in the 2 groups.|72 hours post-operatively|Sample size was too small to conduct outcome analysis||||||
1331560|NCT02075411|Secondary|Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group|Determine the duration of analgesia in the 2 groups. Analgesic duration will be the time interval between the end of the operation and the time of first administration of opioid for pain relief|72 hours post-operatively|Sample size was too small to conduct outcome analysis||||||
1331561|NCT02075411|Primary|Opioid Pain Medication|total postoperative opioid pain medication used during the first 72 hours after the procedure|72 hours post-operatively|Sample size was too small to conduct outcome analysis||||||
1331562|NCT02075320|Secondary|Reader Preference|To evaluate radiologists confidence in evaluating lung nodules of all sizes comparing s-DCT to CT. Readers will be scored using a 7 point Likert scale from -3 to +3. Negative scores in favor of CT and positive scores more in favor of s-DCT. Readers rated images based on shape/morphology, calcifications, and architectural distortion|1 year following imaging||||units on a scale||Standard Deviation|Mean
1331563|NCT02075320|Secondary|Specificity of s-DCT (Percentage) for Malignant Lesions.|"Specificity for this objective is defined as the ability of the s-DCT system to identify a lesion as non-malignant over the course of 1 year post s-DCT. The gold standard will vary depending on the clinical situation as follows:~In the subset of who undergo a biopsy of a suspicious lesion, the pathology report will be the gold standard.~If a biopsy is not performed, but CT scan is performed within the 1 year timeframe, and a diagnosis of malignancy based on this nodule is made, the CT scan will be the gold standard.~If a biopsy or CT scan is not performed, but the clinical records indicate the lesion is malignant (within the one year timeframe), this will be the gold standard."|1 year following imaging|Insufficient numbers of patients had follow-up biopsies, imaging, or follow-up. Ratio could not be calculated as the denominator is 0.||||||
1331564|NCT02075320|Primary|Specificity|Specificity for our study is defined as the ability of s-DCT to correctly identify the absence of a lung nodule as confirmed by CT (gold standard).|1 year following imaging|All subjects|||percentage of negative scans|||Number
1331565|NCT02075320|Primary|Sensitivity|Sensitivity for our study is defined as the ability of s-DCT to detect a lung lesion known to exist based on non-contrast CT (the gold standard) for any sized lung nodule.|1 year following imaging||||percentage of positive scans|||Number
1331566|NCT02075255|Secondary|Inspiratory Capacity|Change from baseline in inspiratory capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
1331567|NCT02075255|Secondary|Functional Residual Capacity|Change from baseline in functional residual capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
1331568|NCT02075255|Secondary|Vital Capacity|Change from baseline in vital capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
1331569|NCT02075255|Secondary|Residual Volume|Change from baseline in residual volume|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
1331570|NCT02075255|Secondary|Total Lung Capacity|Change from baseline in total lung capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
1331571|NCT02075255|Secondary|Percent Change From Baseline in Blood Eosinophil Counts|Percent change from baseline in blood eosinophil counts at week 28|Change from baseline at Week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||percent change||Standard Deviation|Mean
1331572|NCT02075255|Secondary|Anti-drug Antibody Response|Number and percentage of patients in different ADA response categories|From baseline to follow-up Week 36|Safety analysis set|||Participants|||Count of Participants
1331573|NCT02075255|Secondary|Serum Concentration of Benralizumab|Pre-dose serum concentrations at each visit|Pre-first dose to Week 36|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331574|NCT02075255|Secondary|Extent of Exposure|Duration of exposure from first dose date to last dose date.|From first dose to Week 24|Safety analysis set|||Days||Standard Deviation|Mean
1331575|NCT02075255|Secondary|AQLQ(s)+12 Responders (Improvement) at Week 28|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. Improvement is defined as AQLQ(S)+12 (End of treatment - baseline)>=0.5. No change is defined as AQLQ(S)+12 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as AQLQ(S)+12 (End of treatment - baseline) <= -0.5. Baseline is defined as the last AQLQ(S)+12 score prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable score at week 28 are considered as non-responder.|Week 28|Full analysis set|||Participants|||Number
1331576|NCT02075255|Secondary|Change From Baseline at Week 28 in AQLQ(S)+12 (Overall)|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
1331577|NCT02075255|Secondary|ACQ-6 Responders (Improvement) at Week 28|Improvement is defined as ACQ-6 (End of treatment - baseline) <= -0.5. No change is defined as ACQ-6 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as ACQ-6 (End of treatment - baseline) >= 0.5. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations and rescue medication.Scores range from 0 (totally controlled) to 6 (severely uncontrolled). Baseline is defined as the last non-missing value prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable ACQ-6 at week 28 are considered non-responder.|Week 28|Full analysis set|||Participants|||Number
1331578|NCT02075255|Secondary|Change From Baseline to Week 28 in ACQ-6|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
1331579|NCT02075255|Secondary|Change From Baseline to Week 28 in the Proportion of Nights With Awakening Due to Asthma Requiring Rescue Medication|Baseline is defined as the proportion of nights from the evening of study day -14 to the morning of study day 1.Each timepoint is calculated as bi-weekly proportions based on daily diary data. If more than 50% of data are missing in a 14 day period then this will be considered as missing.Proportion of nights with noctural awakenings is defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Proportion||Standard Deviation|Mean
1331580|NCT02075255|Secondary|Change From Baseline to Week 28 in Home Lung Function (Evening Peak Expiratory Flow)|Evening peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Liter/min||Standard Deviation|Mean
1332204|NCT02061969|Secondary|Total Daily Dose of Insulin|Total daily dose of insulin (units)|over 6 months||||U/day||Standard Deviation|Mean
1331581|NCT02075255|Secondary|Change From Baseline to Week 28 in Home Lung Function (Morning Peak Expiratory Flow)|Morning peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Liter/min||Standard Deviation|Mean
1331582|NCT02075255|Secondary|Change From Baseline to Week 28 in Rescue Medication Use|Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this will be considered as missing. The number of inhalations (puffs) per day will be calculated as follows: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times].|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||number of puffs per day||Standard Deviation|Mean
1331583|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Nighttime)|Asthma symptoms during night time are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
1331584|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Daytime)|Asthma symptoms during daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
1331585|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Total)|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
1331586|NCT02075255|Secondary|Change From Baseline to Week 28 in Pre-bronchodilator FEV1|Baseline is defined as the last non-missing value prior to the first dose of study treatment. Change from baseline to Week 28 in two treatment groups is compared to placebo group.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Liter||Standard Deviation|Mean
1331587|NCT02075255|Secondary|Number of Days in Hospital Due to Asthma|Number of days in hospital due to asthma, if none, 0 day is considered|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set|||Days||Standard Deviation|Mean
1331588|NCT02075255|Secondary|The Annualized Rate of Asthma Exacerbations That Are Associated With an Emergency Room Visit or a Hospitalization|The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator that are associated with an emergency room visit or a hospitalization adjusted by the time of follow-up.|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set|||events/year||95% Confidence Interval|Least Squares Mean
1331589|NCT02075255|Secondary|The Annualized Rate of Asthma Exacerbation|The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator adjusted by the time of follow-up.|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set|||events/year||95% Confidence Interval|Least Squares Mean
1331590|NCT02075255|Secondary|Time to the First Asthma Exacerbation Requiring Hospitalization or ER Visit|Time to the first exacerbation requiring hospitalization or ER visit post randomisation|The time from randomisation to the date of first asthma exacerbation associated with hospitalization or ER over 28 weeks.|Full analysis set|||Days||95% Confidence Interval|Median
1331591|NCT02075255|Secondary|Time to the First Asthma Exacerbation|Time to the first occurrence of asthma exacerbation post randomisation|The time from randomisation to the date of first asthma exacerbation over 28 weeks|Full analysis set|||Days||95% Confidence Interval|Median
1331592|NCT02075255|Secondary|Number and Percentage of Patients With ≥1 Asthma Exacerbation|Number and percentage of patients with at least one post randomisation asthma exacerbation.|Immediately following the randomisation through Study Week 28|Full analysis set|||Participants|||Count of Participants
1331593|NCT02075255|Secondary|The Proportion of Patients With Average Final OCS Dose ≤5.0 mg Daily at Visit 14, While Maintaining Asthma Control|Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Participants|||Number
1332205|NCT02061969|Secondary|Number of Hypoglycemic Events < 40mg/dl|total number of severe hypoglycemia (< 40 mg/dl).|over 6 months||||events|||Number
1331594|NCT02075255|Secondary|The Proportion of Patients With ≤5.0 mg Reduction on Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control.|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Participants|||Number
1331595|NCT02075255|Secondary|The Proportion of Eligible Patients With ≥100% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set, eligible for 100% reduction (ie, patients with baseline OCS dose <= 12.5 mg)|||Participants|||Number
1331596|NCT02075255|Secondary|The Percentage of Patients With ≥50% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Participants|||Count of Participants
1331597|NCT02075255|Secondary|Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control for Patients With Baseline Eosinophils >=300/uL|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set, baseline blood eosinophil >=300/uL|||Percent||95% Confidence Interval|Median
1331598|NCT02075255|Secondary|Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control|Number and percentage of patients in different categories of percent reduction from baseline in final OCS dose.|Week 28|Full analysis set|||Participants|||Count of Participants
1331599|NCT02075255|Primary|Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose–final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Percent||95% Confidence Interval|Median
1331600|NCT02075125|Secondary|Pre-procedure Platelet Reactivity Index (PRI)|Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).|||percentage||Inter-Quartile Range|Median
1331601|NCT02075125|Secondary|Number of Participants With Low Platelet Reactivity|Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
1331602|NCT02075125|Secondary|Pre-procedure P2Y12 Reaction Units (PRU)|Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).|||PRU units||Inter-Quartile Range|Median
1331603|NCT02075125|Secondary|Adverse Drug Reaction|Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number, compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
1331604|NCT02075125|Secondary|Bleeding Event|Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
1331605|NCT02075125|Secondary|Major Adverse Cardiac and Cerebrovascular Events|Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
1332206|NCT02061969|Secondary|Number of Hypoglycemic Events < 70mg/dl|total number of hypoglycemic events (<70 mg/dl)|over 6 months||||events|||Number
1331606|NCT02075125|Primary|Number of Participants With High Platelet Reactivity|Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
1331607|NCT02075073|Secondary|Time to Cmax (Tmax)||57 days||||hour||Standard Deviation|Mean
1331608|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)||57 days||||µg·h/mL||Standard Deviation|Mean
1331609|NCT02075073|Primary|Maximum Serum Concentration (Cmax)||57 days||||µg/mL||Standard Deviation|Mean
1331610|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)||57 days||||µg·h/mL||Standard Deviation|Mean
1331611|NCT02075021|Secondary|the Number of Patients Who Achieve Complete Response (CR) or Partial Response (PR) (Phase II)|The response will be determined using the International Uniform Response Criteria for Multiple Myeloma.|up to 2 years|Results were not analyzed due to lack of sufficient data. PI left the institution.||||||
1331612|NCT02075021|Primary|Maximum Tolerated Dose (Phase I)|Dose limiting toxicity will be accessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|4 weeks|Results were not analyzed due to lack of sufficient data. PI left the institution.||||||
1331613|NCT02075008|Primary|Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|52 weeks|The safety set, which included all participants, was analyzed.|||Participants|||Count of Participants
1331614|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331615|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331616|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331617|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331618|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331619|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life||Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331620|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331621|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331622|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331623|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331624|NCT02074995|Primary|Efficacy Measure by Change in Lean Body Mass (LBM)|Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.|Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
1331625|NCT02074995|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with adverse events as a measure of safety and tolerability|Over 1 year||||Participants|||Number
1331626|NCT02074982|Secondary|Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).~PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52"|Week 52|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.|||percentage of participants|||Number
1331627|NCT02074982|Secondary|Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).~Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4"|Week 4|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.|||percentage of participants|||Number
1331628|NCT02074982|Primary|Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).~PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16"|Week 16|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.|||Percentage of Participants|||Number
1331629|NCT02074904|Secondary|Mean Alcohol Consumption|change in mean alcohol consumption from baseline to 9 weeks|baseline to 9 weeks|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
1331630|NCT02074904|Secondary|Heavy Drinking Days|change in number of heavy drinking days from baseline to 9 weeks|baseline to 9 weeks|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
1331631|NCT02074904|Secondary|Change in Gamma-glutamyl Transferase (GGT) or Carbohydrate-deficient Transferrin (CDT) Levels|Change in gamma-glutamyl transferase (GGT) or carbohydrate-deficient transferrin (CDT) levels after 9 weeks of treatment.|baseline and Visit 9 (9 weeks)|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
1331632|NCT02074904|Secondary|Drinking Days|change in drinking days from baseline to 9 weeks|baseline and 9 weeks|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
1331633|NCT02074904|Primary|fMRI Response in the Ventral Striatum/Medial Orbitofrontal Cortex During Alcohol Cue Exposure|At baseline (prior to randomization), brain and behavioral responses will be significantly greater during alcohol cue exposure compared to non-alcohol cue exposure. Following 6 weeks of study drug, individuals receiving topiramate will demonstrate greater reductions in brain activity and drinking behavior compared to individuals receiving placebo. Individuals receiving placebo will exhibit responses similar to baseline responses.|baseline to after 6 weeks of study drug|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
1331634|NCT02074735|Primary|Heavy Drinking Days Per Week|"Heavy drinking days are defined as 4 or more drinks for women, 5 or more drinks for men in a single day. Participants self-reported the type and amount of alcohol consumed during each assessment period. From this information, number of standard drinks per day was calculated using the following formula: (number of drinks) x (oz per drink) x (alcohol by volume or ABV). The average number of heavy drinking days was calculated by dividing the number of heavy drinking days per week by the number of days in the assessment period."|12 weeks||||days/week||Standard Deviation|Mean
1331635|NCT02074709|Primary|Postoperative Pain Score on Coughing at 6 hr|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at 6 hr after surgery||||units on a scale||Standard Deviation|Mean
1331636|NCT02074553|Secondary|Time to Reach Last Quantifiable Plasma Concentration (Tlast) of Alectinib and RO5468924|Tlast is the time from alectinib administration to reach last quantifiable concentration of alectinib and its major pharmacologically active metabolite RO5468924.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Full Range|Median
1331637|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ratio||Standard Deviation|Geometric Mean
1331638|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for AUC(0-last)|AUC(0-last) is the area under the plasma concentration versus time curve from time zero to the time of last measured concentration. AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-last) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ratio||Standard Deviation|Geometric Mean
1331639|NCT02074553|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ratio||Standard Deviation|Geometric Mean
1331640|NCT02074553|Secondary|Adjusted r^2 Value (Rsq) for Regression Estimation of Kel for Alectinib and RO5468924||Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||no units||Standard Deviation|Mean
1332207|NCT02061969|Secondary|HbA1c|HbA1c at 6 month|6 months||||percent of glycosylated hemoglobin||Standard Deviation|Mean
1331641|NCT02074553|Secondary|Percent Extrapolated AUC(0-inf) (AUC%Extrap[0-inf]) for Alectinib and RO5468924|The AUC%extrap(0-inf), that is, area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUC%extrap(0-inf) = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf); where AUC(0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time and AUC(0-last) is area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration. The function of this parameter is to provide information about what percentage of the theoretical curve AUC(0-inf) was possible to determine experimentally (AUC0-last).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||percent AUC||Standard Deviation|Mean
1331642|NCT02074553|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||liters||Standard Deviation|Mean
1331643|NCT02074553|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||liters/hour||Standard Deviation|Mean
1331644|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-last)|AUC(0-last) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib + RO5468924. AUC(0-last) is presented in nmol*hour/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||nmol*hour/L||Standard Deviation|Mean
1331645|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||nmol/L||Standard Deviation|Mean
1331646|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||nmol*hour/L||Standard Deviation|Mean
1331647|NCT02074553|Secondary|Elimination Rate Constant (Kel) of Alectinib and RO5468924|First-order terminal elimination rate constant (Kel) was calculated as the negative slope of the linear regression of the terminal phase in plasma alectinib and RO5468924 concentration versus time profile using appropriate time points. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||1/hour||Standard Deviation|Mean
1331648|NCT02074553|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Standard Deviation|Mean
1331649|NCT02074553|Secondary|AUC(0-last) of RO5468924|AUC(0-last) is the area under the RO5468924 plasma concentration versus time curve from time zero to the time of last measured concentration of RO5468924. RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
1331650|NCT02074553|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
1331651|NCT02074553|Secondary|Tmax of RO5468924|Tmax is the time from alectinib administration to reach Cmax for RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Full Range|Median
1331652|NCT02074553|Secondary|Cmax of RO5468924|Cmax is the maximum observed plasma RO5468924 concentration, presented in ng/mL. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng/mL||Standard Deviation|Mean
1331653|NCT02074553|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib|Tmax is the time from alectinib administration to reach Cmax for alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Full Range|Median
1331654|NCT02074553|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed plasma alectinib concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng/mL||Standard Deviation|Mean
1331763|NCT02071849|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||percentage of blood volume||Standard Deviation|Mean
1331655|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib|AUC(0-last) is the area under the alectinib plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
1331656|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|The Pharmacokinetic (PK) analysis set included all participants who received the reference formulation 50% SLS alectinib (Treatment A) and at least 1 test formulation (Treatments B, C, or D) and provided adequate PK assessments.|||ng*hour/mL||Standard Deviation|Mean
1331657|NCT02074514|Secondary|Percentage of Participants With Virologic Failure and Viral Relapse|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1331658|NCT02074514|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1331659|NCT02074514|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1331660|NCT02074514|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1331661|NCT02074384|Primary|Portion of Study Participants Reporting Greater Utility From AGP vs. Traditional Glucose Data Reports|Patients will use either SMBG or CGM for a two week period following their screening visit. At the end of the two week period they will return to the study site to download their device and have an AGP report printed. They will then complete a preference and utility survey.|At the end of the two week SMBG or CGM period||||participants|||Number
1331662|NCT02074358|Secondary|Mean Change From Baseline Temperature on Day 4 and Day 7|Temperature was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period and was measured in degrees centigrade (C). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had temperature data at baseline and post baseline were analyzed.|||C||Standard Deviation|Mean
1331663|NCT02074358|Secondary|Mean Change From Baseline in Respiration Rate on Day 4 and Day 7|Respiration Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Respiration Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in respirations (breaths) per minute. Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had respiration rate data at baseline and post baseline were analyzed.|||breaths per minute||Standard Deviation|Mean
1331664|NCT02074358|Secondary|Mean Change From Baseline in Heart Rate on Day 4 and Day 7|Heart Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Heart Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in beats per minute (bpm). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had heart rate data at baseline and post baseline were analyzed.|||bpm||Standard Deviation|Mean
1331665|NCT02074358|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7|Blood pressures were recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Blood pressure was measured after the participant had been seated quietly for at least 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had blood pressure data at baseline and post baseline were analyzed.|||mmHg||Standard Deviation|Mean
1331666|NCT02074358|Secondary|Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF|Single 12-lead ECGs were obtained at screening, Day -1 of Period 1, and Days 4 and 7 of each treatment period after the participant had been supine for at least 5 minutes. Pulse Rate (PR), Complex of Q, R, S waves (QRS), and contraction of ventricle between the beginning of the Q wave and end of the T wave (QT) were measured in milliseconds (msec). QT was corrected by the Fridericia method (QTcF) and measured in msec. Baseline was Day -1 of first treatment period. Crossover study: same participant with out of range ECG intervals could be reported in multiple arms.|Day -1 first treatment period, Days 4 and 7 each treatment period|Those participants who received any study medication and had available ECG data at baseline and Days 4 and 7 in each treatment period were analyzed.|||participants|||Number
1331764|NCT02071849|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
1331667|NCT02074358|Secondary|Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population|Blood, urine samples obtained at screening, Days -1, 4, and 7 of each treatment period, and study discharge (Day 11 of Treatment Period 3). MA: Leukocyte White Blood Cells (WBC) *10^3 cells per microliter (c/µL); High (H): > 1.2*upper limits normal (ULN) if lower limits normal (LLN) <= pre-therapy (PreRx) <= ULN; > 1.2*ULN if PreRx = Missing; > 1.5*PreRx if PreRx > ULN; > ULN if PreRx < LLN. Alanine Aminotransferase (ALT) units per liter (U/L); H: > 1.25*PreRx if PreRx > ULN; > 1.25*ULN if PreRx <= ULN; > 1.25*ULN if PreRx = Missing. Total and Direct Bilirubin in milligrams/deciliter (mg/dL) H: > 1.1*ULN if PreRx <= ULN;> 1.1*ULN if PreRx = Missing; > 1.25*PreRx if PreRx > ULN. Blood in Urine H: >= 2*PreRx if PreRx >= 1; >= 2 if PreRx < 1; >= 2 if PreRx = Missing. Urine Red Blood Cells (RBC) and Urine WBC/ high powered field (hpf) H: >= 2 if PreRx = Missing; >= 2 if PreRx < 2; >= 4 if PreRx >= 2. Crossover study: same participant with MA could be reported in multiple arms.|Day 1 (first dose) to Day of Study Discharge (Day 11 of Treatment Period 3)|All participants who received any study medication and had available laboratory test data were analyzed. n=number of participants evaluated.|||participants|||Number
1331668|NCT02074358|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Medical Dictionary for Regulatory Activities (MedDRA) version 17.0 was used.|Day 1 to 30 days Post Last Dose|Treated population: All participants who received at least one dose of study medication were analyzed.|||participants|||Number
1331669|NCT02074358|Secondary|Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. T-HALF was measured in hours|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||hours||Standard Deviation|Mean
1331670|NCT02074358|Secondary|Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Cmin was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331671|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
1331672|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-24) was measured in ng*h/mL.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1331673|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
1331674|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-12) was measured in ng*hours/mL (ng*h/mL)|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1331675|NCT02074358|Secondary|Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Tmax was measured in hours.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||hours||Full Range|Median
1331676|NCT02074358|Secondary|Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) assay within the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331677|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||fraction||95% Confidence Interval|Mean
1331678|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, pre-apixaban dose. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||seconds||95% Confidence Interval|Mean
1331679|NCT02074358|Primary|PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. A dedicated software program (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting “thrombogram” curve. Pre-dose Apixaban baseline was Day 1 pre-dose (0 hour). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period.|Day 1 pre-dose apixaban (pre-apixaban Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM*minute||95% Confidence Interval|Mean
1331680|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour (pre-dose apixaban). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA velocity index was measured in nM/min.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM/min||95% Confidence Interval|Mean
1331694|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Local Reactions|Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
1340182|NCT01940484|Primary|Mean Hemoglobin Value at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
1331681|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM||95% Confidence Interval|Mean
1331682|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||minutes||95% Confidence Interval|Mean
1331683|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Anti-FXa activity was measured using a validated method at Esoterix Coagulation Laboratory (Englewood, CO) using the Diagnostica Stago Rotachrom (Registered) Heparin assay on a STA-Compact (Registered) analyzer. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. The results of this chromogenic assay were reported in low molecular weight heparin (LMWH) activity units per milliliter (U/mL), which are equivalent to international units per milliliter (IU/mL) with assay reportable range: 0.1 to 18.4 IU/mL.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||U/mL||95% Confidence Interval|Mean
1331684|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||fraction||95% Confidence Interval|Mean
1331685|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. PT (Neoplastin CT+), PT (Recombiplastin 2G) and activated partial thromboplastin time (aPTT) parameters were measured in seconds.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||seconds||95% Confidence Interval|Mean
1331695|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)|Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
1331696|NCT02074345|Primary|Number of Participants With Adverse Events|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.|For 64 Weeks|Full Analysis Set (FAS) included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
1331686|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Velocity Index parameter was measured in nM per minute (nM/min).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM/min||95% Confidence Interval|Mean
1331687|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Peak height parameter was measured in nanomolar (nM).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM||95% Confidence Interval|Mean
1331688|NCT02074358|Secondary|PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Lag Time and Time to Peak parameters were measured in minutes.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||minutes||95% Confidence Interval|Mean
1331689|NCT02074358|Primary|Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. Dedicated software (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting “thrombogram” curve. Pre-infusion baseline= sample on Day 4, 3 hours post apixaban dose (just prior to IV infusion of PCC or placebo). Samples on Day 4 were obtained at 0 (pre-dose), 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. ETP was measured as nanomolar*minute (nM*min).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM*min||95% Confidence Interval|Mean
1331690|NCT02074345|Secondary|Geometric Mean Titer (GMT) of Anti-PRP Antibody|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.|||μg/mL||95% Confidence Interval|Geometric Mean
1331691|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.|||percentage of participants||95% Confidence Interval|Number
1331692|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.|||percentage of participants||95% Confidence Interval|Number
1331693|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Systemic Reactions|Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
1331703|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||percentage of participants|||Number
1331704|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1331705|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24||Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||percentage of participants||95% Confidence Interval|Number
1331706|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||percentage of participants||95% Confidence Interval|Number
1331707|NCT02073656|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24||Baseline; Week 12, Posttreatment Weeks 12 and 24|Participants in the Safety Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1331708|NCT02073656|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment||Weeks 4, 8, and 12|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
1331709|NCT02073656|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1331710|NCT02073656|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8||Baseline; Weeks 1, 2, 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1331711|NCT02073656|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1331712|NCT02073656|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1331713|NCT02073656|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1331714|NCT02073656|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who enrolled and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1331715|NCT02073461|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331716|NCT02073461|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331717|NCT02073461|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331718|NCT02073461|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331719|NCT02073461|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331720|NCT02073461|Secondary|Percent of Subjects With Adverse Events|Adverse events which were observed in 5% or more patients with either group are listed.|up to 12 weeks||||percentage of participants|||Number
1331721|NCT02073461|Primary|Percent Changes From Baseline in Total Lesion Counts|Median percent reductions from Baseline in total lesion count (ITT-LOCF)|Baseline - Week 12||||percent change||Full Range|Median
1331722|NCT02073448|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331723|NCT02073448|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331724|NCT02073448|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331725|NCT02073448|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331726|NCT02073448|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
1331727|NCT02073448|Secondary|Percent of Subjects With Adverse Events||up to 12 weeks||||percentage of participants|||Number
1331728|NCT02073448|Primary|Percent Changes From Baseline in Total Lesion Counts||Baseline - Week12||||percent change||Full Range|Median
1331730|NCT02072980|Primary|Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn|Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 16 hours|This analysis population includes all participants who completed the study.|||unitless||Standard Deviation|Mean
1331731|NCT02072928|Primary|Change From Baseline in Anticholinergic Drug Use|Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted.|Baseline, 9 Months|Treatment responders for whom pharmacy data is available|||Doses of Anticholinergic Drugs||Standard Error|Mean
1331732|NCT02072421|Secondary|Major Vascular Complications|Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure.|30 days||||participants|||Number
1331733|NCT02072421|Secondary|Revascularization|Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure|30 days||||participants|||Number
1331734|NCT02072421|Secondary|Stroke|Stroke through 30 days post-procedure|30 days||||participants|||Number
1331735|NCT02072421|Secondary|All-Cause Mortality|all-cause mortality through 30 days post-procedure|30 days||||participants|||Number
1331736|NCT02072421|Primary|Major Adverse Cardiac Event (MACE)|MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days.|30-days||||participants|||Number
1331737|NCT02072226|Secondary|Percentage of Participants With Serious Adverse Events|A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|From baseline to Day 90|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
1331738|NCT02072226|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From baseline up to Day 90: Non-serious adverse events were collected through the Day 30 visit. Serious adverse events were collected through the end of study at Day 90.|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
1331739|NCT02072226|Secondary|Percentage of Participants Who Died Due to Stroke and Neurological Disorders|Reported here is the percentage of participants who died due to stroke and neurological disorders.|From baseline to Day 90|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
1331740|NCT02072226|Secondary|Overall Mortality|Reported here is the percentage of participants who died due to any cause during the study.|From baseline to Day 90|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
1331741|NCT02072226|Secondary|Percentage of Participants With Any ICH|To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.|Within 36 hours after study drug administration on Day 1|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
1331742|NCT02072226|Secondary|Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )|ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.|Within 36 hours after study drug administration on Day 1|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
1331743|NCT02072226|Secondary|Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS|Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0−1, National Institutes of Health Stroke Scale (NIHSS) Score 0−1, Barthel Index [BI] greater than or equal to 95, and Glasgow Outcome Scale [GOS] equal to 1. mRS Score 0−1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales.|Day 90|ITT population included all randomized participants.|||percentage of participants|||Number
1331744|NCT02072226|Secondary|Distribution of Participants Across the Ordinal mRS|mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death before Day 90. Reported are the percentages of participants for all scores on the mRS.|Day 90|ITT population included all randomized participants.|||percentage of participants|||Number
1331765|NCT02071849|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
1331745|NCT02072226|Primary|Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90|mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.|Day 90|Intent-to-Treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1331746|NCT02072200|Secondary|Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12|Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects.|12 weeks|ITT set was 145 patients, but 11 patients data was not assessed except baseline score.|||scores on a scale||Standard Deviation|Mean
1331747|NCT02072200|Secondary|Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale|The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking.|Baseline and 12 weeks|ITT population was 145, but 3 patients were not assessed for primary efficacy parameter of morning stiffness severity. So, Last Observation Carried Forward (LOCF) was not done for these 3 patients after baseline . Other patients' missing data were handled using LOCF method.|||mm||Standard Deviation|Mean
1331748|NCT02072200|Primary|Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary|"Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.~Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure."|Baseline and 12 weeks|ITT set = 145 patients. Missing data was handled as LOCF.|||minutes||Standard Deviation|Mean
1331749|NCT02072096|Other Pre-specified|Change From Baseline in Mini-mental State Examination (MMSE) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.||||||
1331750|NCT02072096|Other Pre-specified|Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.||||||
1331751|NCT02072096|Other Pre-specified|Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.||||||
1331752|NCT02072096|Secondary|Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)|The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline eGFR data.|||milliliter per minute/1.73 square meter||Standard Deviation|Mean
1331753|NCT02072096|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline BMI data.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
1331754|NCT02072096|Secondary|Change From Baseline of Urinary Albumin to Creatinine Ratio|The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline urinary albumin to creatinine ratio.|||milligram per millimole (mg/mmol)||Standard Deviation|Mean
1331755|NCT02072096|Secondary|Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.|||Participants|||Number
1331756|NCT02072096|Secondary|Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.|||percentage of participants|||Number
1331757|NCT02072096|Primary|Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia|Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c > upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c > upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose <3.0 mmol/L. Success is defined as lacking of failure.|Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1331758|NCT02071849|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min/m^2||Standard Deviation|Mean
1331759|NCT02071849|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min/m^2||Standard Deviation|Mean
1331760|NCT02071849|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min||Standard Deviation|Mean
1331770|NCT02071849|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
1331771|NCT02071849|Secondary|Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Deviation|Mean
1331772|NCT02071849|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||g||Standard Deviation|Mean
1331773|NCT02071849|Secondary|Left Ventricular (LV) Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||g||Standard Deviation|Mean
1331774|NCT02071849|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
1331775|NCT02071849|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
1331776|NCT02071849|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
1331777|NCT02071849|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
1331778|NCT02071849|Secondary|NYHA Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years postprocedure|Participants with an evaluation of this measure.|||Participants|||Count of Participants
1331779|NCT02071849|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months postprocedure|Participants with an evaluation of this measure.|||Participants|||Count of Participants
1331780|NCT02071849|Secondary|Aortic Insufficiency (AI) at 2 Years|Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure.|||Participants|||Count of Participants
1331781|NCT02071849|Secondary|Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.||2 years||||percentage of participants||95% Confidence Interval|Number
1331782|NCT02071849|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|2 years postprocedure||||percentage of participants||95% Confidence Interval|Number
1331783|NCT02071849|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|6 months postprocedure||||percentage of participants||95% Confidence Interval|Number
1331784|NCT02071849|Secondary|Implant Procedure Success|Success is defined as the absence of specified adverse events evaluated through discharge following the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.|discharge or 14 days postprocedure, whichever comes first||||percentage of participants||95% Confidence Interval|Number
1331785|NCT02071849|Primary|Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months|Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)|6 months postprocedure|Participants with an echocardiogram evaluable for this measure.|||Participants|||Count of Participants
1331786|NCT02071849|Primary|Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.||6 months postprocedure||||percentage of participants||95% Confidence Interval|Number
1331787|NCT02071823|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067|Day 1||||ng·h/mL||Standard Deviation|Mean
1331788|NCT02071823|Primary|AUCt - Cumulative Area Under the Plasma Concentration Time Curve|AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067|Day 1||||ng·h/mL||Standard Deviation|Mean
1331789|NCT02071823|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of BIA 9-1067|Day 1||||ng/mL||Standard Deviation|Mean
1331790|NCT02071810|Primary|Number of Patients With at Least One Adverse Event||participants will be followed for the duration of hospital stay, an expected average of 6 weeks||||Number of patients|||Number
1331803|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 30 days|30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions||Number
1332923|NCT02047500|Secondary|Percentage of Subjects With Disease Control According to RECIST Version 1.1 Criteria||Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment|||||||
1331791|NCT02071771|Secondary|Lens Oscillation at Blink at Day 10|Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.|Day 10, each product|This analysis group includes all randomized subjects at the UK site with data at visit who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||degrees||Standard Deviation|Mean
1331792|NCT02071771|Primary|High Contrast Time Controlled Visual Acuity (TCVA) at Day 10|TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||VA units||Standard Deviation|Mean
1331793|NCT02071420|Primary|Change in Occupational Physical Activity From Baseline to 16 Weeks|Occupational physical activity (primary outcome) will be measured objectively with the GENEActiv physical activity monitor. The monitor will be worn on the right ankle and will be worn for 5 working days during all non-bathing hours. The outcome measure will be change in occupational activity (average counts/work day) from baseline to 16 weeks. The measure will be calculated as follows: 16 weeks value - baseline value.|Baseline and 16 weeks||||Average counts/work day||95% Confidence Interval|Mean
1331794|NCT02071108|Other Pre-specified|Exploratory Endpoint|The clinical protocol provided for an Exploratory Secondary Endpoint to assess the ability of the device to achieve ≤30% residual stenosis without adjunctive PTA as assessed by the investigator via visual estimate.|Day of Procedure|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions||Number
1331795|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||Rutherford Clinical Category||95% Confidence Interval|Mean
1331796|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Lithoplasty treatment was successfully completed|||Ankle Brachial Index||95% Confidence Interval|Mean
1331797|NCT02071108|Secondary|Patency|Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions|95% Confidence Interval|Number
1331798|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 6 months|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions||Number
1331799|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 6 months|6 months|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of participants|||Number
1331800|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||change in RCC from baseline||95% Confidence Interval|Mean
1331801|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed. Four subjects were not included in the analysis because ABI could not be measured due to non-compressible disease that inhibited accurate ABI measurement.|||change in ABI score from baseline||95% Confidence Interval|Mean
1331802|NCT02071108|Secondary|Patency|Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5).|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted. Due to device malfunctions, one subject received partial treatment. To provide a more accurate account of actual device usage, the subject was omitted from the analysis of device usage only.|||percentage of lesions|lesions|95% Confidence Interval|Number
1331804|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 30 days.|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of participants|||Number
1331805|NCT02071108|Secondary|Technical Success:|The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of lesions|lesions|95% Confidence Interval|Number
1331806|NCT02071108|Secondary|Clinical Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of participants||95% Confidence Interval|Number
1331807|NCT02071108|Secondary|Device Success|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment attempted|||percentage of lesions|lesions|95% Confidence Interval|Number
1331808|NCT02071108|Primary|Procedural Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted.|||percentage of lesions|lesions|95% Confidence Interval|Number
1331809|NCT02071108|Primary|Composite of New-onset Major Adverse Events (MAE)|Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.|30 days||||participants|||Number
1331810|NCT02071095|Secondary|Percent Change in CD4+ Tcell-associated HIV-1 RNA as Compared to Baseline|CD4+ Tcell-associated HIV-1 RNA to determine whether Poly-ICLC disrupts viral latency in HIV-1-infected individuals on anti-retroviral therapy.Viral transcription assessed by monitoring cell associated HIV-1 RNA. Percent change compared to baseline.|Baseline, Day 2, Day 4, Day 8, Day 28||||percent change||Standard Deviation|Mean
1331811|NCT02071095|Secondary|NK Cell Number|Natural killer cells or NK cells are part of the innate immune defense against infection and cancer.|at 48 weeks||||cells/µL||Standard Deviation|Mean
1331812|NCT02071095|Secondary|CD8 CD38 (Mean of Fluorescence)|the CD38-activation marker on CD8 T-cells (CD8/CD38).|Day 8||||mean fluorescent intensity (MFI)||Standard Deviation|Mean
1331813|NCT02071095|Secondary|Plasma Interferon-gamma-inducible Protein-10 (IP-10) Level|One of the biomarkers of cellular immune activation and exhaustion quantified by flow cytometry. Normal range is 7.8–500 pg/ml.|Day 2 and Day 4||||pg/ml||Standard Deviation|Mean
1331814|NCT02071095|Primary|Number Participants With Adverse Events|Safety measured by number of participants with adverse events.|Up to 48 weeks||||Participants|||Count of Participants
1331815|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 48|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1331816|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 24|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Inter-Quartile Range|Median
1331817|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBe at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
1331818|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
1331819|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBs at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
1331820|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
1331821|NCT02071082|Secondary|Percentage of Participants With Normalized ALT at Week 48|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 48|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.|||percentage of participants|||Number
1331822|NCT02071082|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 24|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.|||percentage of participants|||Number
1331823|NCT02071082|Secondary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.|Week 48|Full Analysis Set|||percentage of participants|||Number
1331824|NCT02071082|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1331825|NCT02071082|Primary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.|Week 24|Full Analysis set|||percentage of participants|||Number
1331826|NCT02071082|Primary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, had at least 1 post-Day 1 plasma HBV DNA or HIV-1 RNA result while on study, and had no major protocol violations from the eligibility criteria.|||percentage of participants|||Number
1331827|NCT02070965|Primary|The Number of Subjects With HPA Axis Suppression||Day 15|Three subjects in the 28 day DFD01 Treatment Group, three subjects in the 14 day Comp01 Treatment Group, and one subject in the 14 day DFD01 Treatment Group did not have ACTH stimulation test results.|||Participants|||Count of Participants
1331828|NCT02070744|Secondary|PC Phase: Time to Reach Cmax (Tmax) of VX-661 and IVA||Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses.|||hour||Full Range|Median
1331829|NCT02070744|Secondary|PC Phase: Area Under the Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12h) of IVA||Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||hr*ng/mL||Standard Deviation|Mean
1331830|NCT02070744|Secondary|PC Phase: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24h) of VX-661|Pharmacokinetic (PK) sampling was performed up to 12 hours post-dose on Day 85. For Arm VX-661 50 mg q12h + IVA 150 mg q12h (VX-661 q12h regimen), area under the concentration versus time curve from time 0 to 12 hours (AUC0-12h) was multiplied by 2 to obtain AUC0-24h.|Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||Hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
1331831|NCT02070744|Secondary|PC Phase: Maximum Plasma Concentration (Cmax) of VX-661 and IVA||Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1331832|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in CFQ-R Respiratory Domain Score Through Week 40|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||units on a scale||95% Confidence Interval|Least Squares Mean
1331833|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 12|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||units on a scale||95% Confidence Interval|Least Squares Mean
1331834|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline BMI at Week 40|BMI was calculated using following formula: BMI = Weight in kg/height in m^2. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||kg/m^2||95% Confidence Interval|Least Squares Mean
1331835|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline Body Mass Index (BMI) at Week 12|BMI was calculated using following formula: BMI = Weight in kg/height in square meter (m^2). Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||Kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
1331836|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in Body Weight at Week 40|Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||kg||95% Confidence Interval|Least Squares Mean
1331837|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Body Weight at Week 12|Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||kilogram (kg)||95% Confidence Interval|Least Squares Mean
1331850|NCT02070692|Primary|Bleeding Days|The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.|180 days||||days||Standard Deviation|Mean
1331838|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in Sweat Chloride Through Week 40|Sweat samples were collected using an approved collection device. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||mmol/L||95% Confidence Interval|Least Squares Mean
1331839|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Sweat Chloride Through Week 12|Sweat samples were collected using an approved collection device. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||Millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1331840|NCT02070744|Secondary|OLE Phase: Relative Change From Baseline in Percent Predicted FEV1 Through Week 40|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||Percent change||95% Confidence Interval|Least Squares Mean
1331841|NCT02070744|Secondary|PC Phase: Relative Change From Baseline in Percent Predicted FEV1 Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||Percent change||95% Confidence Interval|Least Squares Mean
1331842|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in Percent Predicted FEV1 Through Week 40|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in OLE phase.|||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1331843|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1331844|NCT02070744|Primary|OLE Phase: Number of Participants With Treatment-Emergent AEs and SAEs|AE: Any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase) up to 364 days|Safety Set was defined as all participants who received at least 1 dose of study drug in OLE Phase.|||Participants|||Count of Participants
1331845|NCT02070744|Primary|PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: Any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase) up to 112 days|Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase.|||Participants|||Count of Participants
1331846|NCT02070692|Secondary|Number of Participants Experiencing Ovulation After First Use of Study Drug|A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.|30 days|Number of subjects analyzed are those that provided urine samples. No subject who provided urine samples was excluded from this analysis.|||Participants|||Count of Participants
1331847|NCT02070692|Secondary|Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)|Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.|180 days|Number of subjects analyzed is the number of subjects who completed a final study visit (either completion of full study or early termination visit) to provide a final estimation of satisfaction.|||units on a scale||Standard Deviation|Mean
1331848|NCT02070692|Primary|Consecutive Bleeding-free Days After Study Drug|Consecutive bleeding-free days after study drug|up to 180 days|Number of subjects analyzed is the number of subjects who started taking the study drug. One subject in the tamoxifen arm and there in the placebo arm did not initiate study drug.|||days||Standard Deviation|Mean
1331849|NCT02070692|Primary|Bleeding/Spotting Days|Bleeding/spotting days|30 days|Number of patients analyzed is number of patients who completed 30 days of follow up. Two subjects in the tamoxifen arm and three in the placebo arm were lost to follow up prior to 30 days.|||days||Standard Deviation|Mean
1331851|NCT02070640|Secondary|Time to Complete NIRF-C and IOC|The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.|Intraoperative||||minutes||Full Range|Mean
1331853|NCT02070640|Primary|Complications Related to ICG|A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.|From time of injection to 1st post-op follow-up||||% of Participants with Complications|||Number
1331854|NCT02070588|Secondary|Operator Set MRI Parameters|To record operator-adjusted parameters of the novel software on the MRI system|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected||||||
1331855|NCT02070588|Secondary|Subject Demographics|To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected||||||
1331856|NCT02070588|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected||||||
1331857|NCT02070484|Secondary|Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion|CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.|6 and 12 months|The study was terminated due to low enrollment; therefore, CT scans at 6 and 12 months were not conducted.||||||
1331858|NCT02070484|Primary|Oswestry Disability Index|The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.|12 months|The study was terminated due to low enrollment; therefore, this endpoint was not analyzed.||||||
1331859|NCT02070380|Secondary|Lesion-brain Contrast-to-noise Ratio|"The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is the mean difference in CNR (MultiHance - Dotarem)"|5-10 minutes Postdose||||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
1331860|NCT02070380|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is “the mean difference in LBR postdose (MultiHance – Dotarem)”|5-10 minutes Postdose||||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
1331861|NCT02070380|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||Participant Exams|||Number
1331862|NCT02070380|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||participant exams|||Number
1331863|NCT02070380|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||participant exams|||Number
1331864|NCT02070380|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||participant exams|||Number
1331865|NCT02070380|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations|||participant exams|||Number
1331866|NCT02070302|Primary|Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.|Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.|Baseline-Week 18||||Pounds of Force (LBF)||Standard Deviation|Mean
1332924|NCT02047500|Secondary|Duration of Overall Response According to RECIST Version 1.1 Criteria||Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment|||||||
1331867|NCT02070302|Primary|Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.|Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.|Baseline to Week 18||||milliseconds||Standard Deviation|Mean
1331868|NCT02070302|Primary|Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.|Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline|Baseline, week 6, week 12, and week 18.||||milliseconds||Standard Deviation|Mean
1331869|NCT02070302|Primary|Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.|Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.|Baseline to Week 18||||% change||Standard Deviation|Mean
1331870|NCT02070302|Primary|Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.|Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40|Baseline-Week 18|Levine functional severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. This scale ranges from 1 (no symptoms) to 5 (severe symptoms). The function severity scale indicate interference of the symptoms on activities of daily living. Mean values reported for each group.|||Scores on a scale||Standard Deviation|Mean
1331871|NCT02070302|Primary|Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.|Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55.|Baseline-Week 18|Levine symptom severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. It ranges from 1 (no symptoms) to 5 (severe symptoms). This scale indicate how severe the CTS symptoms feel to the patient. Mean values (std deviation) are reported both Onabot and Placebo groups.|||Scores on a scale||Standard Deviation|Mean
1331872|NCT02070237|Secondary|Supraprophylactic Range Anti Xa Level|We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).|3.5-4 hours after the third dose of Lovenox (enoxaparin)||||participants|||Number
1331873|NCT02070237|Primary|Anti Xa Level|Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.|3.5-4 hours after the third dose of Lovenox (enoxaparin)||||IU/mL||95% Confidence Interval|Mean
1331874|NCT02069093|Secondary|Blood Concentration of Everolimus and Exemestane|Blood samples were collected and analyzed.|28 days (pre-dose)|The PK analysis set, which was a subset of the FAS, was considered for the analysis. However, only participants who had evaluable data were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331875|NCT02069093|Secondary|Dose Intensity of Everolimus and Exemestane|The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||mg/day||Full Range|Median
1331876|NCT02069093|Secondary|Number of Participants With All Grades of Stomatitis|The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|The FAS, consisting of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash), was considered for the analysis. However, only those participants, who were evaluable for stomatitis grade, were analyzed.|||Participants|||Number
1331877|NCT02069093|Secondary|Median Number of Mouthwashes Per Day|The median number of mouthwashes per day was assessed.|56 days|FAS: The FAS set consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||Number of mouthwashes||Full Range|Median
1331878|NCT02069093|Secondary|Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less|The number of days to achieve resolution of stomatitis from grade 2 or greater to grade 1 or less was assessed. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||Days||Full Range|Median
1331879|NCT02069093|Primary|Number of Participants With Stomatitis Grade ≥ 2|The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|Full analysis set (FAS): The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||Participants|||Number
1331880|NCT02068547|Secondary|Neck Pain Affects Every Day Activities|Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.|24 Months|||||||
1331881|NCT02068547|Secondary|Physical and Mental Health From Subject's Point of View|Short Form 36 (SF-36) is a profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.|24 months|||||||
1331882|NCT02068547|Primary|Rate of Fusion|Rate of fusion – (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.|6 months, 12 months, 24 months|||||||
1332136|NCT02063230|Primary|Cmax of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised Cmax outcome measure|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1331883|NCT02068495|Secondary|Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment|Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg.|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given time point.|||Percentage of Participants|||Number
1331884|NCT02068495|Secondary|Changes From Baseline in Pulse Rate at Final Assessment|Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months).|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||Beats per minute||Standard Deviation|Mean
1331885|NCT02068495|Secondary|Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment|Reported data are changes in DBP from baseline at final assessment (up to 12 months).|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mmHg||Standard Deviation|Mean
1331886|NCT02068495|Secondary|Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment|Reported data are changes in SBP from baseline at final assessment (up to 12 months).|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mmHg||Standard Deviation|Mean
1331887|NCT02068495|Primary|Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to 12 Months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
1331888|NCT02068495|Primary|Number of Participants Who Experience at Least One Adverse Events||Up to 12 Months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
1331889|NCT02068443|Secondary|Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings|Number of participants who had ECG findings changed from “normal” or “abnormal but not clinically relevant” at Baseline to “abnormal and clinically relevant”.|Baseline and Weeks 12 and 24|"Safety Analysis Set, all participants who received at least 1 dose of study drug, with ECG values normal or abnormal not clinically significant at Baseline."|||participants|||Number
1331890|NCT02068443|Secondary|Percentage of Participants With TEAEs Related to Vital Signs|Vital signs included sitting systolic and diastolic blood pressures (mmHg) (measured after resting for ≥ 5 minutes) and pulse rate (beats per minute [bpm]).|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1331891|NCT02068443|Secondary|Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis|The percentage of participants with any clinically relevant safety laboratory changes (chemistry, hematology and urinalysis) collected throughout study and recorded as AEs.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1331892|NCT02068443|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1331893|NCT02068443|Secondary|Fasting Blood Glucose|The value of the fasting plasma glucose collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||mg/dL||Standard Deviation|Mean
1331894|NCT02068443|Secondary|Change From Baseline in Fasting Blood Glucose|The change in the value of the fasting plasma glucose collected at Weeks 2, 4, 8, 12, 16, 20 and 24 relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||mg/dL||Standard Deviation|Mean
1331895|NCT02068443|Secondary|Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period|HbA1c (NGSP) is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The percentage of participants with HbA1c levels of ≥6.0, ≥7.0 and ≥8.0 at the end of Screening (Baseline) with change to target values <6.0, <7.0 and <8.0 respectively at EOT.|Baseline and EOT (Up to Week 24)|FAS included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1331896|NCT02068443|Secondary|HbA1c (NGSP)|The value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percent||Standard Deviation|Mean
1332208|NCT02061969|Primary|Mean Fasting Blood Glucose Level|The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.|6 months||||mg/dl||Standard Deviation|Mean
1331897|NCT02068443|Secondary|Change From Baseline in HbA1c (NGSP)|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 2, 4, 8, 12, 16, 20, 24, and EOT relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percent||Standard Deviation|Mean
1331898|NCT02068443|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses.|Baseline and End of Treatment (EOT) (Up to Week 24)|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.|||percent||Standard Error|Least Squares Mean
1331899|NCT02068222|Secondary|The Percentage of Subjects With Post-Treatment Relapse|Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.|Within 12 weeks after the last dose of study drug||||percentage of participants||95% Confidence Interval|Number
1331900|NCT02068222|Secondary|The Percentage of Subjects With Virologic Failure During Treatment|Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.|Up to Treatment Week 12||||percentage of participants||95% Confidence Interval|Number
1331901|NCT02068222|Secondary|The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)|SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.|24 weeks after last dose of study drug||||percentage of participants||95% Confidence Interval|Number
1331902|NCT02068222|Primary|The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)|SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.|12 weeks after last dose of study drug||||percentage of participants||95% Confidence Interval|Number
1331903|NCT02068157|Secondary|Serum Alkaline DNase (SADA) Activity|SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.|Up to 12 months|The published assay could not be validated in murine samples. As such, no human samples were analyzed.||||||
1331904|NCT02068157|Primary|Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1|Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 months|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1331905|NCT02068027|Secondary|Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worst score from Day -14 to Day -8) to End-of-Treatment (worst score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “worst pain in the past 24 hours in the painful areas of the feet” from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the endpoint, the change in worst pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline worst pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
1331906|NCT02068027|Primary|Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score|The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the “average pain in the past 24 hours in the painful areas of the feet” averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model.|The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
1331907|NCT02067858|Other Pre-specified|Correlation of Imaging Response With Serum Protein and Peptide Profiles|Research blood draws looking at imaging repsonse before and after radiation in relationship to serum protein and peptide profiles|2 years|Blood draw samples were not drawn nor analyzed for this study||||||
1331908|NCT02067858|Secondary|Assess Progression-free Survival|Number of patients with Progression Free Survival at 2 Years|2 years||||Participants|||Count of Participants
1331909|NCT02067858|Primary|Assess Clinical Response Rate and Local Control Following SBRT Treatment of Patients With Early Stage NSCLC|The Number of Patients that completed SBRT|2 years||||Participants|||Count of Participants
1331910|NCT02067728|Secondary|BMI Z-score Change for Ages 11-17 Years||Baseline and 6 months post encounter||||BMI z-score||Standard Deviation|Mean
1331911|NCT02067728|Secondary|BMI Z-score Change for Ages 4-10 Years||Baseline and 6 months post encounter||||BMI z-score||Standard Deviation|Mean
1332444|NCT02058940|Secondary|Percentage of Hypotensive Episodes (SBP<100 mmHg)|Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.|Over 48 hours from infusion initiation||||percentage of measurements|||Number
1331912|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 6 months post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 6 months post encounter.|||percentage of participants|||Number
1331913|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 1 month post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 1 month post encounter.|||percentage of participants|||Number
1331914|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 6 months post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|6 months post encounter|This analysis population only includes those participants who initially set an obesiogenic focused goal at their well child check and then responded to the survey 6 months after to rate their success level in achieving that goal.|||percentage of participants|||Number
1331915|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 1 month post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|1 month post encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 1 month after the medical encounter to rate their level of success in achieving that goal.|||percentage of participants|||Number
1331916|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 6 months after the encounter. Success defined as response of 2-4 on survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months after encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 6 months after the medical encounter when goal was set.|||percentage of participants|||Number
1331917|NCT02067728|Other Pre-specified|Obesity Follow-up Adherence|Subjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter|6 months after the encounter|This analysis population only includes the subjects who were identified as obese at their initial appointment and had a 6 month follow up appointment scheduled at that time.|||percentage of participants|||Number
1331918|NCT02067728|Other Pre-specified|Perception of Patient Centeredness of Encounter|Patient centeredness survey which measures the parent's and patient's (if 12 years and older) perception of how patient centered the communication was with the provider. Survey Coding for Patient Centeredness: 1=Not at all; 2=A little; 2.5=Can't say; 3=Somewhat; 4=A lot|1 month after the encounter||||units on a scale||Standard Deviation|Mean
1331919|NCT02067728|Other Pre-specified|BMI Z-score Change for All|Anthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter.|Baseline and 6 months after the encounter|The number of participants analyzed is low because returning for measurement checks was optional at 6 months & only 28% usual care and 27% intervention group attended. We also included chart abstraction measurements for those who had a return clinic visit with measurements within 6 months +/- 2 months from initial encounter.|||BMI z-score||Standard Deviation|Mean
1331920|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 1 month after the encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month after the encounter|This analysis population only includes the participants who set an obesiogenic goal at the initial appointment and completed the 1 month post survey to rate their success level in achieving that goal.|||percentage of participants|||Number
1331921|NCT02067728|Primary|Percentage of Patients With Documented Goal Setting|Health behavior change goal documented in charting of well-child visits.|2 weeks from encounter|Manual chart review of the electronic medical record (EMR) was completed by the Research Team for all enrolled subjects in both study groups. Goal documentation was defined as any type of goal consisting of an active verb written either on the FNPA Tool which was completed during the well child visit or in Physician notes in the EMR for the visit.|||percentage of participant charts|||Number
1331922|NCT02067676|Secondary|Interferon Titers Among All Cohorts|CRM197-specific interferon-y (IFNy) responses measured from PBMC on day0, 28 and 56|Day 0, 28 and 56||||GMTs||95% Confidence Interval|Geometric Mean
1331923|NCT02067676|Secondary|Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses|"Anti-CRM^197 IgG ASC Responses - GMTs with 95% CI.~A positive immunoglobulin A (IgA)-ASC response will be defined as a > twofold increase over the baseline value of the ASCs per 10^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma)."|Study Days 0-56||||GMTs||95% Confidence Interval|Geometric Mean
1331924|NCT02067676|Secondary|Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells|"Anti-CPS IgG ASC Responses - GMTs with 95% CI.~A positive immunoglobulin A (IgA)-ASC response will be defined as a > twofold increase over the baseline value of the ASCs per 10^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma)."|Study Days 0-56||||GMTs||95% Confidence Interval|Geometric Mean
1332007|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Creatinine|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Creatinine"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||umol/L||Standard Deviation|Mean
1331925|NCT02067676|Secondary|Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)|"Primary immunologic parameters, serum samples were assessed for the antibody titers against Campylobacter jejuni conjugate vaccine1 (CJCV1) using ELISA (enzyme-linked immunosorbent assay) based methods.~Antibody-secreting cell(s) (ASCs): >0.5 per 10(6) Peripheral blood mononuclear cell (PBMCs) in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10(6) PBMCs. ((6) is superscript).~= Seroconversion was defined as >4fold increase in endpoint titer between pre- and post-vaccine samples and a post-vaccine reciprocal titer >10.~= Response is defined as a >2fold increase over the baseline value of ASC per 10(6) PBMCs, when the number of ASCs is >0.5 per 10(6) PBMCs in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccine value was greater than 1.0 per 10(6) PBMCs."|Study Days 0-56|Campylobacter jejuni conjugate vaccine (1CJCV1); antibody-secreting cell(s) (ASCs); Peripheral blood mononuclear cell (PBMCs)|||% of immune response|||Number
1331926|NCT02067676|Primary|Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)|Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions through targeted physical exams, symptom surveys, and other adverse event (AE) monitoring. All subjects will be observed in the clinic for at least 30 minutes after receipt of the investigational product. Approximately 48 hours after vaccination, subjects will return to the Clinical Trials Center for observation and reporting of any local and/or systemic AEs. Seven days after vaccine administration, subjects will return to the Clinical Trials Center to review their memory aids with study personnel and to report any AEs. In addition to planned visits, if a subject experiences any unanticipated AE, the subject will be seen by one of the study investigators. All AEs will be coded for onset date, duration, severity, and potential relationship to the investigational product.|up to 7 days|Rates of all AEs were analyzed by Pearson’s Chi-square test (or Fisher’s exact test if assumptions were not met for Pearson’s Chi-square) to compare groups.|||Adverse Events|||Number
1331927|NCT02067611|Other Pre-specified|Amount of Rescue Medication (Acetaminophen) Consumed Per Day for Target Knee Pain.|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331928|NCT02067611|Other Pre-specified|Change From Baseline Over Time in VAS Pain Scores for the Target Knee From Daily Diary Data.|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331929|NCT02067611|Other Pre-specified|Investigator’s Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331930|NCT02067611|Other Pre-specified|Subject’s Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331931|NCT02067611|Other Pre-specified|Investigator's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331932|NCT02067611|Other Pre-specified|Subject's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331933|NCT02067611|Secondary|Characterize the Pharmacokinetics of X0002|Cmax, Tmax, AUCs, apparent terminal elimination rate constant, apparent terminal elimination half-life will be calculated.|at the Week 2, week 3, week 4 and Week 12|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331934|NCT02067611|Secondary|To Assess the Effect of X0002 Spray Compared to Placebo on Difficulty Performing Daily Activities|"A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.~The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1332102|NCT02063672|Secondary|Percentage of Participants Without Minor Limb Amputation|Minor limb amputation is defined as amputation of a part of the foot below the ankle.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1331935|NCT02067611|Secondary|To Evaluate the Effect of X0002 Spray Compared to Placebo for the Relief of Joint Stiffness|"A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.~The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 4, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331936|NCT02067611|Secondary|To Assess the Safety and Tolerability of Multiple Doses of X0002 When Administered as a Topical Spray|"A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.~The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|2, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331937|NCT02067611|Primary|To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee|"The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at 4 weeks of treatment, and will be analyzed using an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates. The primary comparisons of interest will be the difference between active Group A (low dose) and combined placebo, active Group B (middle dose) and combined placebo, and active Group C (high dose) and combined placebo.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|4 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
1331938|NCT02067585|Secondary|Glucose||6 hours||||mmol/L||Standard Deviation|Mean
1331939|NCT02067585|Secondary|Glucose||4 hours||||mmol/L||Standard Deviation|Mean
1331940|NCT02067585|Secondary|Glucose||90 minutes||||mmol/L||Standard Deviation|Mean
1331941|NCT02067585|Secondary|Glucose||30 minutes||||mmol/L||Standard Deviation|Mean
1331942|NCT02067585|Secondary|Blood Glucose||0 minute||||mmol/L||Standard Deviation|Mean
1331943|NCT02067585|Primary|Triglyceride||6 hours||||mmol/L||Standard Deviation|Mean
1331944|NCT02067585|Primary|Triglyceride||4 hours||||mmol/L||Standard Deviation|Mean
1331945|NCT02067585|Primary|Triglyceride||90 minutes||||mmol/L||Standard Deviation|Mean
1331946|NCT02067585|Primary|Triglycerides||30 minutes||||mmol/L||Standard Deviation|Mean
1331947|NCT02067585|Primary|Triglycerides Post-prandial||0 minutes||||mmol/L||Standard Deviation|Mean
1331948|NCT02067533|Primary|Knee Range of Motion (ROM)|in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.|1 year after total knee arthroplasty||||degree||Standard Deviation|Mean
1331949|NCT02067273|Primary|Present Pain Intensity|Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.|Baseline, post-treatment, one week follow-up|Data from participants who completed the study were analyzed.|||Units on a scale||Standard Deviation|Mean
1331950|NCT02066922|Secondary|Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1|Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject’s current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.|Baseline, Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.|||Eyes|||Number
1331951|NCT02066922|Primary|Change in Average Central Corneal Curvature From Dispense at Week 1|Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.|Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.|||diopters||Standard Deviation|Mean
1331952|NCT02066896|Secondary|Salivary Flux Measurement|"The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C.~Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min."|6 weeks||||ml/min||Standard Deviation|Median
1331953|NCT02066896|Secondary|Salivary Biomarker Analysis. Beta 2 Microglobulin.|"The saliva in Sögren`s syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium.~The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885).~The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren`s syndrome 5,3 +/- 4,6 microg/ml.~This measure was done in the samples of saliva before and after the lasertherapy for all patients."|6 weeks||||microg/ml||Standard Deviation|Median
1332103|NCT02063672|Secondary|Percentage of Participants Without Major Limb Amputation|Major limb amputation is defined as amputation of the lower limb above the ankle.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1331954|NCT02066896|Primary|The Xerostomia Inventory|"The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more.~Bellow we describe all the 11 questions:~I sip liquids to aid in swallowing food~My mouth feels dry when eating a meal~I get up at night to drink~My mouth feels dry~I have difficulty in eating dry foods~I suck sweets or cough lollies to relieve dry mouth~I have difficulties swallowing certain foods~The skin of my face feels dry~My eyes feel dry~My lips feel dry~The inside of my nose feels dry __________________________________________________________~Score:~Never’ (1), Hardly ever’ (2), Occasionally’ (3), Fairly often’ (4), Very often’ (5)"|6 weeks|Intent to treat population. Last observation carried forward imputation method.|||units on a scale||Standard Deviation|Mean
1331955|NCT02066857|Secondary|Change in SF-12 QOL|The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities.|Baseline, Month 3|No participants completed this survey as this outcome measure was removed from the protocol. No data were collected.||||||
1331956|NCT02066857|Secondary|Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score|The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||units on a scale||Standard Deviation|Mean
1331957|NCT02066857|Primary|Mean Pain Score|"Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing no pain and 10 representing the worst pain imaginable. The assessment was completed at all study visits."|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||units on a scale||Standard Deviation|Mean
1331958|NCT02066857|Primary|Complication Rate|The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.|Duration of Study (Up to 3 Months)|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||Participants|||Count of Participants
1331959|NCT02066857|Primary|Change in Grip Strength|Grip strength will be assessed by bilateral dynamometer testing.|Baseline, Month 3|Data for this outcome measure are not available for analysis.||||||
1331960|NCT02066857|Primary|Mean Mayo Wrist Score|The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||units on a scale||Standard Deviation|Mean
1331961|NCT02066857|Primary|Change in Wrist Range of Motion (ROM)|Wrist ROM will be assessed by a goniometer exam.|Baseline, Month 3|Data for this outcome measure are not available for analysis.||||||
1331962|NCT02066740|Primary|Successful Stent Deployment|Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.|Procedure||||percentage - successful stent deployment|Participants||Number
1331963|NCT02066740|Primary|Absence of Stent Elongation|Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length|Intra operative||||percentage absence of stent elongation|Participants||Number
1331964|NCT02066727|Secondary|Complication Related With Nerve Block|Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively|during operation, 0.5,24hour postoperatively|||||||
1331965|NCT02066727|Primary|Median Effective Concentration(EC50)|"Median effective concentration(EC50) was not calculated per-participants, the up-and-down sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration.~For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows."|10min||||mg/ml(the concentration of lidocaine)||95% Confidence Interval|Number
1331966|NCT02066415|Secondary|Number of Participants Who Developed Antibodies to Erenumab|"Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).~Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.~If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies."|Baseline and weeks 2, 4, 8, 12 and 24|Randomized participants who received at least one dose of study drug and with available post-baseline antibody data. This endpoint was analyzed in the erenumab treatment groups only.|||Participants|||Count of Participants
1331967|NCT02066415|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:~Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE."|From the first dose of study drug up to 16 weeks after the last dose (24 weeks)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1331968|NCT02066415|Secondary|Change From Baseline in Cumulative Monthly Headache Hours|"The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.~A qualified headache was defined as follows:~a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or~a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or~a headache of any duration for which acute headache treatment was administered."|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|"The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.~The number of participants analyzed includes those with observed data at week 12."|||hours / month||95% Confidence Interval|Least Squares Mean
1331969|NCT02066415|Secondary|Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days|Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|"The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.~The number of participants analyzed includes those with observed data at week 12."|||acute migraine treatment days / month||95% Confidence Interval|Least Squares Mean
1331970|NCT02066415|Secondary|Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of treatment.~At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|"The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.~Participants with missing post-baseline data were counted as non-responders."|||percentage of participants|||Number
1331971|NCT02066415|Primary|Change From Baseline in Monthly Migraine Days|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week treatment phase – the number of migraine days during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement. The number of participants analyzed includes those with observed data at week 12.|||migraine days / month||95% Confidence Interval|Least Squares Mean
1331972|NCT02066402|Secondary|Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
1331973|NCT02066402|Secondary|Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
1331974|NCT02066402|Secondary|Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
1331975|NCT02066402|Secondary|Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
1331976|NCT02066402|Secondary|Investigator’s Assessment of Clinical Response at Day 7 Visit|The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other.|Baseline and Day 7 visit|ITT|||Percentage of participants|||Number
1331977|NCT02066402|Secondary|Investigator’s Assessment of Clinical Response at 48-72 Hours|The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other.|Baseline and at 48-72 hours|ITT|||Percentage of participants|||Number
1331978|NCT02066402|Secondary|Overall Investigator’s Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set|The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.|Baseline and post-therapy evaluation visit (7-14 days after Day 11)|CE-PTE|||Percentage of participants|||Number
1331979|NCT02066402|Secondary|Overall Investigator’s Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set|The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.|Baseline and post-therapy evaluation visit (7-14 days after Day 11)|ITT|||Percentage of participants|||Number
1331980|NCT02066402|Secondary|Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set|Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.|Baseline and EOT visit (Day 11)|CE-EOT|||Percentage of participants|||Number
1331981|NCT02066402|Secondary|Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set|Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48‑72 H Visit.|Baseline and EOT visit (Day 11)|ITT|||Percentage of participants|||Number
1331982|NCT02066402|Primary|Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.|Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.|Baseline and 48-72 hours visit|ITT|||Percentage of participants|||Number
1331983|NCT02066233|Secondary|Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy|"Subjects were asked the following question: Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future? Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test."|Two weeks|Two subjects on the reflux and/or heartburn arm didn't answer this question.|||Participants|||Count of Participants
1331984|NCT02066233|Primary|Median Tolerability Score on 10-point Visual Analog Scale (VAS)|"On the 10-point VAS, 0 represented the worst experience and 10 the best experience."|Within 48 hours||||units on a scale||Full Range|Median
1331985|NCT02066129|Secondary|Number of Participants Hospitalized for Asthma|Number of participants hospitalized for asthma during the 48 week treatment period.|end of 48 week treatment period||||Participants|||Count of Participants
1331986|NCT02066129|Secondary|Unscheduled Emergency Department (ED) or Urgent Care Visits for Asthma|Rate of emergency department (ED) or urgent care visits for asthma during the 48 week treatment period.|end of 48 week treatment period||||visits per year||95% Confidence Interval|Least Squares Mean
1331987|NCT02066129|Secondary|Yellow Zone Albuterol Use|Use of albuterol rescue medication during 7-day yellow zone episodes.|end of 48 week treatment period||||number of albuterol puffs||95% Confidence Interval|Least Squares Mean
1331988|NCT02066129|Secondary|Yellow Zone Asthma Symptoms|Study participants completed a daily symptom diary. They scored the following diary elements on a scale from 0-3 (none-severe): Cough, Wheeze, Trouble Breathing, Interference With Activities. A combined score was calculated as the sum of the 4 elements and ranged from 0 to 12. The study intervention was based on yellow-zones as noted in the Study Description. This outcome was based on diary data including 21 days, beginning 7 days prior to the onset of the yellow-zone intervention and ending 14 days after the onset of the intervention. The total symptom burden outcome was defined as the sum of the combined score on each diary day and ranged from 0 to 252 (max combined score of 12 per day multiplied by 21 days). A score of zero would indicate no symptoms over the entire 21 days. A score of 252 would indicate severe cough, wheeze, shortness of breath, and interference with activities on all of the 21 days.|end of 48 week treatment period||||units on a scale||95% Confidence Interval|Least Squares Mean
1331989|NCT02066129|Primary|Asthma Exacerbations|The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.|end of 48 week treatment period||||exacerbations per year||95% Confidence Interval|Least Squares Mean
1331990|NCT02066051|Secondary|Number of Participants Who Experienced Adverse Events|Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.|12 months||||participants|||Number
1331991|NCT02066051|Primary|Number of Participants Who Responded to Intense Pulsed Light (IPL)|Participants received treatment over 4 months and were monitored for safety and response for an additional 8 months. The symptoms were scored with the Standard Patient Evaluation of Eye Dryness (SPEED2) questionnaire. The SPEED questionnaire presents the four most commonly experienced dry eye symptom groups and asks patients to tick a box for all symptoms that apply to them. The frequency section ratings run from 0 (never) to 3 (constant), and the severity section ratings run from 0 (no problems) to 4 (intolerable), for a total score ranging from 0 (no problem) to 28 (severe problems). Over a 30% improvement in the SPEED2 score equated a response. None of the subjects were expected to get a complete response due to the nature of the damage to their ocular surface from GVHD.|12 months||||participants|||Number
1331992|NCT02065895|Other Pre-specified|Nighttime Time-in-target 5.0-8.33mmol/l (Controller Set-point Plus and Minus 15 mg/dL)|Night-time in target range 5.0-8.33, following the 3 hour controller initialization period blood glucose remained at or near target.|On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 12:00 AM to 6:00 AM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors|Analysis was limited to the 6 subjects completing all 3 nighttime periods per protocol|||percentage of time in target range||Inter-Quartile Range|Median
1331993|NCT02065895|Secondary|Peak and Nadir Postprandial Glucose Concentration|Highest and lowest glucose concentrations obtained during breakfast meal.|On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 8:00 AM to 12:00 PM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors|Analysis was limited to the 5 subjects completed all aspects of the study per protocol (i.e. 5 subjects who completed all three scheduled breakfast meals).|||mmol/l||95% Confidence Interval|Mean
1331994|NCT02065895|Primary|Glucose Area Under the Curve (AUC) Breakfast|Glucose Area Under the Curve (AUC) Breakfast defines the total exposure to glucose during breakfast. Breakfast is typically considered the most difficult meal to control; low AUC is desirable.This outcome measure was analyzed for each of the three calibration error values (high error, no error and low error).|On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 8:00 AM to 2:00 PM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors||||mmol/l/min||95% Confidence Interval|Mean
1331995|NCT02065453|Primary|The Primary Endpoint of This Study is Time Difference Between Cauterizing One Side of the Uterine Attachments, From the Round Ligament to the Uterine Artery on One Side, to the Time Detaching the Same Tissues on the Other Side|duration of surgery|Primary outcome study data is collected with the first incision and completed with skin closure at the completion of the surgery.|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min)|||minutes||Full Range|Median
1331996|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)|To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
1331997|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)|To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
1331998|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Bicarbonate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Bicarbonate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
1331999|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Blood Urea Nitrogen"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
1332000|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Protein|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Protein"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||g/L||Standard Deviation|Mean
1332001|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Albumin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Albumin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||g/L||Standard Deviation|Mean
1332002|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Phosphate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Phosphate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
1332003|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Chloride|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Chloride"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
1332004|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Potassium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Potassium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
1332005|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Sodium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Sodium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
1332006|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Total Bilirubin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Total Bilirubin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||umol/L||Standard Deviation|Mean
1332104|NCT02063672|Secondary|Percentage of Participants Without All-Cause Death|Mortality from any cause.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1332008|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alkaline Phosphatase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ukat/L||Standard Deviation|Mean
1332009|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Aspartate Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ukat/L||Standard Deviation|Mean
1332010|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alanine Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ukat/L||Standard Deviation|Mean
1332011|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Glucose|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Glucose"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
1332012|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Platelets|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Platelets"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||10^9/L||Standard Deviation|Mean
1332013|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Leukocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Leukocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||10^9/L||Standard Deviation|Mean
1332014|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Hemoglobin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Hemoglobin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||g/L||Standard Deviation|Mean
1332015|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Erythrocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Erythrocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||10^12/L||Standard Deviation|Mean
1332016|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1332017|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332018|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332019|NCT02064985|Secondary|Safety---Vital Signs Over Time---Pulse Rate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Pulse Rate)"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||BEATS/MIN||Standard Deviation|Mean
1332020|NCT02064985|Secondary|Safety---Vital Signs Over Time---Weight|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Weight)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||kg||Standard Deviation|Mean
1332021|NCT02064985|Secondary|Safety---Vital Signs Over Time---Height|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Height)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||cm||Standard Deviation|Mean
1332022|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(4)|Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1332023|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(3)|Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332024|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(1)|The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332025|NCT02064985|Secondary|Safety---Causally Related Adverse Events by System Organ Class and Preferred Term|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Assessment of adverse events"|Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||Participants|||Number
1332026|NCT02064985|Secondary|Safety---All Allowed Concomitant Medications During Study Treatment|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Concomitant medications"|All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||Participants|||Number
1332027|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---hematocrit|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---hematocrit"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ratio||Standard Deviation|Mean
1332028|NCT02064985|Secondary|Safety---Physical Examination, Summary of Abnormalities|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Physical examination"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||Participants|||Number
1332029|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax|To determine Cmax ratio of metabolite to that of the parent compound on Day 7|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
1332030|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax|To determine Cmax ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
1332031|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
1332032|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332033|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
1332034|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332035|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(2)|The pharmacokinetics parameters of ticagrelor on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
1332036|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(2)|The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332037|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(3)|The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
1332038|NCT02064985|Secondary|AUEC(Final Extent) on Day 7|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||%*h||Standard Deviation|Mean
1332039|NCT02064985|Secondary|AUEC(Final Extent) on Day 1|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||%*h||Standard Deviation|Mean
1332040|NCT02064985|Secondary|TIPA(Max)---Day 7|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||hour||Inter-Quartile Range|Median
1332041|NCT02064985|Secondary|TIPA(Max)---Day 1|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||hour||Inter-Quartile Range|Median
1332042|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 7|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||% change from baseline||Standard Deviation|Mean
1332043|NCT02064985|Primary|IPA on Day 7|"The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||% IPA||Standard Deviation|Mean
1332044|NCT02064985|Secondary|Safety---Vital Signs Over Time---Blood Pressure|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (seated blood pressure [BP])"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmHg||Standard Deviation|Mean
1332045|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(1)|Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332046|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 1|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (e.g., non-compliance with study drug) will be included in the PD analysis set.|||% change from baseline||Standard Deviation|Mean
1332105|NCT02063672|Secondary|Percentage of Participants Without Major Vascular Complications (≤30 Day)|Freedom from major vascular complications at 30 days follow-up|30 Days|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1332137|NCT02063230|Primary|AUC (0 to Infinity) of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised AUC outcome measure|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1332047|NCT02064985|Primary|IPA on Day 1|"The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||% IPA||Standard Deviation|Mean
1332048|NCT02064920|Secondary|Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment|OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.|Weeks 4, 8, 12 and 16|All participants who received study medication and yielded at least one measurement for that endpoint.|||Percentage of Corrrect Responses||Standard Deviation|Mean
1332049|NCT02064920|Primary|One-card Learning (OCL) Measurement Over 12 Weeks of Treatment|OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.|Weeks 4, 8, 12 and 16|All participants who received study medication and yielded at least one measurement for that endpoint.|||Score on a scale||Standard Deviation|Mean
1332050|NCT02064907|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5|AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
1332051|NCT02064907|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1|AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
1332052|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
1332053|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
1332054|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng/mL||Standard Deviation|Mean
1332055|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng/mL||Standard Deviation|Mean
1332056|NCT02064894|Secondary|Serious Adverse Event - Side Effects and Serious Adverse Events|To verify the occurence of any serious adverse event, such as respiratory depression or deep sedation, during all the time-periods of the study|60, 90 and 120 minutes||||Participants|||Count of Participants
1332057|NCT02064894|Primary|Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm|"Percentage of participants which pain intensity has decreased under 30 mm on the VAS at 60 minutes.~The Visual Analogue Scale is a 0 to 100 mm continuous scale measuring the pain intensity. Score of 0=No Pain; Score of 100=Worst imaginable pain"|60 minutes post-analgesia||||Percentage of participants||95% Confidence Interval|Number
1332058|NCT02064439|Secondary|Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days|The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.|Up to 12 months, at least 6 months||||participants|||Number
1332059|NCT02064439|Secondary|Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism|The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.|Up to 12 months, at least 6 months||||participants|||Number
1332119|NCT02063672|Primary|Percentage of Participants With Primary Patency at 1 Year|Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.|12 Months|All subjects who completed a 12-Month follow-up visit|||Percentage of Participants||95% Confidence Interval|Number
1332060|NCT02064439|Primary|Number of Participants With First Treatment-emergent Major Bleeding|"The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.~Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant."|Up to 12 months, at least 6 months||||participants|||Number
1332061|NCT02064439|Primary|Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism|"The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.~Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant."|Up to 12 months, at least 6 months||||participants|||Number
1332062|NCT02064270|Secondary|Need for Antibiotics|The need for additional antibiotics will be recorded.|35 days (+/- 14 days)||||Participants|||Count of Participants
1332063|NCT02064270|Secondary|Return to the Operating Room|Information regarding the subject returning to the operating room within the research study time-frame will be recorded.|35 days (+/- 14 days)||||Participants|||Count of Participants
1332064|NCT02064270|Secondary|Number of Participants With Complications|Complications experienced by the subject within the study period time-frame will be recorded.|35 days (+/- 14 days)||||participants|||Number
1332065|NCT02064270|Secondary|User-friendliness for Patient|"User-Friendliness of PICO device:~Easy to use (no difficulties, no instruction needed)~Slightly difficult (needed instruction)~Minor difficulties (but able to use effectively)~Difficult (not able to use effectively)"|7 days||||Participants|||Count of Participants
1332066|NCT02064270|Secondary|Drainage Amount|"Incision Drainage:~Slight (barely noticed)~Moderate (significant amount, but did not have to change dressing)~Extensive (had to change dressing)"|35 days (+/- 14 days)||||Participants|||Count of Participants
1332067|NCT02064270|Primary|Incision Appearance Based on VAS (Incision Healing Assessment Form)|Visual Analog Pain Scale (VAS): PICO Study Incision Healing Assessment Form. Used to represent the assessment of incision healing based on in-person visual appearance, or appearance based on standard digital photograph. This number is reported as a total score on a 0-100 scale, with 0 being poor incision healing and 100 being excellent incision healing.|35 days (+/- 14 days)||||units on a scale||Standard Deviation|Mean
1332068|NCT02064231|Primary|Degree of Leakage|Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).|14 days||||units on a scale|baseplates|Standard Deviation|Mean
1332069|NCT02064205|Secondary|Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.|"The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between.~The satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B).~Area under the curves were calculated of the time curves."|Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.|Only in condition A and B blood was drawn and satiety hormones were analyzed.|||(mcg*min)/mL||Standard Deviation|Mean
1332070|NCT02064205|Secondary|The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)|The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)|one day||||mm*min||Standard Deviation|Mean
1332071|NCT02064205|Primary|Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.|Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.|Four hours or 1.5 hour after consumption of a pre-load at up to day 22|Energy intake|||kJ||Standard Deviation|Mean
1332072|NCT02063880|Secondary|Number of Participants With Potential Drug Toxicity|Participants with adverse events that are deemed to be potentially related to medications.|6 months post-HAART initiation||||participants|||Number
1332073|NCT02063880|Secondary|Number of Participants With Evidence of Immune Reconstitution and Inflammatory Syndrome (IRIS)|Confirmed, possible or likely IRIS based on external independent review|6 months post-HAART initiation||||participants|||Number
1332074|NCT02063880|Primary|All-cause Mortality||6 months post-HAART initiation||||participants|||Number
1332075|NCT02063854|Secondary|Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)|New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra’s height was reduced from the baseline by at least 20% and by at least 4 mm.|Baseline to Month 12|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percentage of participants|||Number
1332135|NCT02063230|Primary|Dose Normalized AUC, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1332076|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit|Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332077|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332078|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332079|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332080|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332081|NCT02063854|Secondary|Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit|The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332082|NCT02063854|Secondary|Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit|The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332083|NCT02063854|Secondary|Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit|The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332084|NCT02063854|Secondary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit|The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
1332085|NCT02063854|Primary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study|The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and End of Study (up to Month 12)|Full Analysis Set (FAS), all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percent change||Standard Deviation|Mean
1332086|NCT02063737|Secondary|Intentions Subscale of the SFAB|An individual’s intent to engage in behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work with higher scores indicating greater intent. Range is 0 (strongly agree) to 100 (strongly disagree).|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332087|NCT02063737|Secondary|Habits Subscale of the SFAB|Endorsement of behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work ranging from 0 (strongly agree) to 100 (strongly disagree). Strongly agree (lower score) is associated with high level of endorsement of behaviors (habits) that promote improved alertness.|end of study at the 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332088|NCT02063737|Secondary|Environmental Constraints Three Subscale of the SFAB|Degree of importance of personal/work-life barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her responsibilities unrelated to the organization as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332089|NCT02063737|Secondary|Environmental Constraints Two Subscale of the SFAB|Degree of importance of employer policies that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer’s policies and organizational related procedures/protocols as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332090|NCT02063737|Secondary|Environmental Constraints One Subscale of the SFAB|Degree of importance of employer based barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer’s policies and organizational related procedures/protocols as factors that inhibit the individual’s ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332091|NCT02063737|Secondary|Importance Subscale of SFAB|Level of importance an individual places on the need to maintain alertness and reduce feelings of fatigue and/or sleepiness while at work ranging from 0 (strongly disagree) to 100 (strongly agree). Strongly agree (higher score) is associated with high level of importance (endorsement) placed on the need to maintain alertness and reduce feelings of fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332092|NCT02063737|Secondary|Knowledge-two Subscale of the SFAB|Perceived degree of evidence that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332093|NCT02063737|Secondary|Knowledge-one Subscale of SFAB|Perception that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332094|NCT02063737|Secondary|Self Efficacy Subscale of the SFAB|Degree of confidence from 0 (cannot do at all) to 100 (highly certain can do) for completing activities. Higher scores indicate the individual has a high-level of self-confidence he/she can perform select behaviors that may improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332095|NCT02063737|Secondary|Normative Beliefs Scale Two Subscale of the SFAB|Belief of people's views if they thought you were very fatigued mentally or physically while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332096|NCT02063737|Secondary|Normative Beliefs Scale One Subscale of the SFAB|Belief of people's views if they thought you were sleepy and fighting the urge to sleep while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332097|NCT02063737|Secondary|Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work on future shifts. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332098|NCT02063737|Secondary|Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|Assessed at the end of 90-day study period|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
1332099|NCT02063737|Primary|Self-Reported Fatigue at End of Shift Work|Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).|At the end of scheduled work shifts during a 90 day study period|Analysis using intention to treat.|||units on a scale|Participants|Standard Error|Least Squares Mean
1332100|NCT02063672|Secondary|Percentage of Participants Without Any Target Limb Reinterventions|Any surgical intervention in the target limb.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1332101|NCT02063672|Secondary|Percentage of Participants Without Target Vessel Revascularizations (TVR)|A TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1332106|NCT02063672|Secondary|Change in Quality of Life From Baseline|"EQ-5D is a standardized tool to assess patient-reported mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, or slight, moderate, severe, or extreme problems. Patients choose the appropriate level in each of the 5 dimensions, which results in a 1-digit number for each dimension. The digits for the 5 dimensions are converted into a single EQ-5D™ index score based on a set of population-based preference weights. For the U.S. general population, possible EQ-5D™ index scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. A downloadable scoring file is available at: https://www.ahrq.gov/rice/EQ5Dscore.htm.~The EQ VAS records a patient’s self-rated health on a vertical visual analogue scale, where the endpoints are labeled ‘The best health you can imagine’ (100) and ‘The worst health you can imagine’ (0). A higher VAS value indicates a higher quality of life."|6 months and 12 Months|All participants with evaluable data|||units on a scale||Standard Deviation|Mean
1332107|NCT02063672|Secondary|Change in Walking Impairment Questionnaire From Baseline|The Walking Impairment Questionnaire (WIQ) is a validated questionnaire that evaluates walking ability with a focus on walking distance, walking speed, and the ability to climb stairs. Participants answer each item on a Likert scale from 0 for “unable to do” to 4 for “no difficulty”, and each response is weighted based on the difficulty of the task. The overall score is determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. The overall score ranges from 0–100 with lower scores indicating lower performance.|6 months and 12 months|All participants with evaluable data|||units on a scale||Standard Deviation|Mean
1332108|NCT02063672|Secondary|Change of Resting Ankle Brachial Index (ABI) From Baseline|The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).|6 months and 12 months|All participants with evaluable data|||ratio||Standard Deviation|Mean
1332109|NCT02063672|Secondary|Change of Rutherford Classification From Baseline|The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.|6 months and 12 months|All patients with evaluable data.|||units on a scale||Standard Deviation|Mean
1332110|NCT02063672|Secondary|Percentage of Participants With Sustained Clinical Benefit Compared to Baseline|Sustained clinical benefit is defined as an improvement in Rutherford Classification compared to baseline and freedom from target vessel revascularization. The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.|6 months and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1332111|NCT02063672|Secondary|Percentage of Participants Without Target Lesion Revascularization (TLR)|TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.|6 months and 12 months|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
1332112|NCT02063672|Secondary|Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)|Clinically-driven TLR is defined as revascularization of the target vessel with evidence of target vessel diameter stenosis >50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms), OR revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.|6 months and 12 months|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
1332113|NCT02063672|Secondary|Percentage of Participants With Secondary Patency at 6 Months and 12 Months|Secondary patency is defined as the absence of Binary Restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.|6 months and 12 months|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
1332114|NCT02063672|Secondary|Percentage of Participants With Primary Patency at 6 and 12 Months|Primary Patency is defined as Freedom from CEC-adjudicated Clinically-Driven TLR and from Core laboratory-adjudicated Binary Restenosis. Binary restenosis is based on threshold Doppler peak systolic velocity ratio (PSVR) ≥ 2.5 (together with waveform analysis & color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).|6 months and 12 months|All participants with evaluable data at each time point.|||Percentage of Participants||95% Confidence Interval|Number
1332115|NCT02063672|Secondary|Percentage of Participants With Procedural Success|Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, amputation of the target limb, or repeat revascularization of the target lesion) during the index procedure and through the hospital stay.|During the Index Procedure (90 mins)|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
1332116|NCT02063672|Secondary|Percentage of Participants With Technical Success|Technical success of the balloon procedure is defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion and a successful withdrawal of the study system with the achievement of < 30% residual percent stenosis without deployment of a bail-out stent.|During the Index Procedure (90 mins)||||Percentage of Participants||95% Confidence Interval|Number
1332117|NCT02063672|Secondary|Percentage of Participants With Device Success|Device success is defined as, on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.|During the Index Procedure (90 mins)|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
1332118|NCT02063672|Primary|Percentage of Participants Without Primary Safety Events|Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year|12 Months|All participants with 12-month evaluable data for the primary safety endpoint.|||Percentage of Participants||95% Confidence Interval|Number
1332120|NCT02063659|Secondary|Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline|Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.The Placebo arm is not included because all participants in the Placebo arm were receiving SSA therapy at Baseline.|||counts/day||Standard Deviation|Mean
1332121|NCT02063659|Secondary|Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points|The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.|Baseline and 12 weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||counts/day||Standard Deviation|Mean
1332122|NCT02063659|Secondary|Change From Baseline in Abdominal Pain Averaged Across All Time-Points|Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||score on a scale||Standard Deviation|Mean
1332123|NCT02063659|Secondary|Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points|Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||counts/day||Standard Deviation|Mean
1332124|NCT02063659|Secondary|Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points|Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||score on a scale||Standard Deviation|Mean
1332125|NCT02063659|Secondary|Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks|Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||counts/day||Standard Deviation|Mean
1332126|NCT02063659|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks)|Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.|||Participants|||Count of Participants
1332127|NCT02063659|Primary|Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels|u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||percentage change of mg/24 hours||Standard Deviation|Mean
1332128|NCT02063659|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)|Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.|||Participants|||Count of Participants
1332129|NCT02063516|Other Pre-specified|Amount of Air Added to Keep Cuff Pressure 60cmH20.|The accuracy of the intrinsic cuff pressure indicator is assessed by documenting which colour band the indicator is displaying when inflated according to manufacturers instructions, and measuring the numeric cuff pressure at the same time with a standard analogue cuff pressure gauge. The manufacturer has documented what pressure range is meant to be indicated by each of three colour ranges.|30 minutes, 60 minutes, 90 minutes and 120 minutes||||ml||Standard Deviation|Mean
1332130|NCT02063516|Secondary|Anatomic Position|This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O.|5 min|"Fiber-optic scoring system:~1, clear view of vocal cord 2, Only arytenoids visible 3, Only epiglottis visible 4, No laryngeal structures visible"|||participants|||Number
1332131|NCT02063516|Primary|Oropharyngeal Seal Pressure|This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.|5 min||||cmH2O||Standard Deviation|Mean
1332132|NCT02063230|Primary|Dose Normalized Cmax, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1332133|NCT02063230|Primary|Dose Normalized AUC, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1332134|NCT02063230|Primary|Dose Normalized Cmax, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1332138|NCT02063217|Primary|Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline|Overnight (01:00 to 11:00) differences in CSF amyloid beta from baseline (07:00 to 19:00) between 1) sleep-deprived and control participants and 2) sleep-induced and control participants.|Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00|Participants in good general health who had CSF collected every 2 hours for 36 hours while undergoing with sleep deprivation, sleep induction with drug, or control conditions.|||percent increase from mean baseline||Standard Error|Mean
1332139|NCT02063035|Secondary|Post-operative Blood Transfusions During Hospitalization|All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.|From end of surgery on Day 1 to end of hospital stay up to approximately 5 days||||units of blood||Inter-Quartile Range|Median
1332140|NCT02063035|Secondary|Hospital Length of Stay in Days|The number of days the participants stayed in the hospital after surgery was recorded.|From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks||||days||Inter-Quartile Range|Median
1332141|NCT02063035|Secondary|Blood Loss Volume Following Surgery|Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.|From end of surgery on Day 1 to end of hospital stay up to approximately 5 days||||mL||Inter-Quartile Range|Median
1332142|NCT02063035|Primary|Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge|Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.|From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery|Only participants, for whom both preoperative and postoperative time points were collected, are reported in this outcome measure.|||grams per deciliter (g/dL)||Inter-Quartile Range|Median
1332143|NCT02062905|Secondary|Conjunctival Redness|"Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; 0 = no redness)"|14 days post insertion||||units on a scale (0 - 4)||Standard Deviation|Mean
1332144|NCT02062905|Primary|Ocular Itching|"Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; 0 = no itching)"|14 days post insertion||||units on a scale (0 -4)||Standard Deviation|Mean
1332145|NCT02062879|Secondary|Median Pain Score|Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.|Participants will be followed for their entire hospital stay, an expected average of 1 week||||scores on a scale||Inter-Quartile Range|Median
1332146|NCT02062879|Secondary|Breakthrough Daily Opioid Requirement|Breakthrough daily opioid requirement in milligrams of morphine equivalents/day|Participants will be followed for their entire hospital stay, an expected average of 1 week||||mg morphine equivalents/day||Inter-Quartile Range|Median
1332147|NCT02062879|Primary|Total Daily Opioid Requirement|Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents|Participants will be followed for their entire hospital stay, an expected average of 1 week.||||mg morphine equivalents/day||Inter-Quartile Range|Median
1332148|NCT02062801|Secondary|Urgent Cesarean Delivery|Incidence of urgent cesarean delivery|Within 30 minutes of combined spinal epidural (CSE) placement||||participants|||Number
1332149|NCT02062801|Secondary|Tetanic (Sustained) Uterine Contraction (TUC)|Incidence of Tetanic (sustained) Uterine Contraction (TUC)|Within 30 minutes of combined spinal epidural (CSE) placement||||participants|||Number
1332150|NCT02062801|Primary|Early Profound Fetal Bradycardia|Incidence of early profound fetal bradycardia|Within 30 minutes of combined spinal epidural (CSE) placement||||participants|||Number
1332151|NCT02062710|Primary|Change in Cough Reflex Sensitivity to Capsaicin|increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|2 hours after study drug administration||||log C5 (uM)||Standard Error|Mean
1332152|NCT02062658|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|2 weeks||||participants|||Number
1332153|NCT02062645|Secondary|SBP and DBP in Patients With High Sodium Intake at Week 4 and 8|Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.|At week 4 and 8|All patients received amlodipine/valsartan 160/5 mg daily at Day 0 and were up titrated to amlodipine/valsartan 160/10 mg daily at visit 2 (week 4) if their hypertension can not be controlled. The duration of treatment period was 8 weeks.|||mmHg||Standard Deviation|Mean
1332154|NCT02062645|Secondary|Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8|Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day)|At week 4 and 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||Percentage of participants|||Number
1332155|NCT02062645|Secondary|Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8|Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.|baseline, week 4, week 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||mmHg||Standard Deviation|Mean
1332199|NCT02061969|Secondary|Total Number of Complications|Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality.|6 months||||events|||Number
1332156|NCT02062645|Secondary|Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8|Change in systolic blood pressure measured in office from baseline at week 4 and 8.|baseline, week 4, week 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||mmHg||Standard Deviation|Mean
1332157|NCT02062645|Primary|Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8|Control rate of BP defined as BP lower than 140/90 mmHg at office visits|At week 4 and 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||Percentage of Participants|||Number
1332158|NCT02062580|Secondary|Vaccine Immunogenicity|Percent of CD4+ T cells expressing Ki67 after stimulation in vitro with BCG.|6 weeks after BCG vaccination|Analysis population n is smaller than enrollment numbers as we calculated that that only 28 were needing in each arm to detect a difference.|||percentage of Ki67% CD4+ T cells||Inter-Quartile Range|Median
1332159|NCT02062580|Primary|T Cell Activation|Percentage of all CD4+ T cells expressing HLADR (NOT BCG-specific activation as in Tchakoute et al and as in secondary outcome). The n is smaller than the enrollment number as some participants were lost to follow-up, some were excluded due to HIV infection etc, and some samples did not have sufficient cells to analyse.|at 6 weeks||||percentage of CD4+ T cells||Inter-Quartile Range|Median
1332160|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2||Up to 5 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2.|||Percentage of participants|||Number
1332161|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1||Up to 5 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.|||Percentage of participants|||Number
1332162|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2||Up to 42 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2|||Percentage of participants|||Number
1332163|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1||Up to 42 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.|||Percentage of participants|||Number
1332164|NCT02062502|Secondary|Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)||Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)|The analysis population is All Subjects as Treated with temperature data at the time of assessment.|||Percentage of participants|||Number
1332165|NCT02062502|Primary|Geometric Mean Titer of VZV Antibodies|Antibody titers were measured with gpELISA.|6 weeks (43 days) after vaccination 1|The analysis population is participants with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1332166|NCT02062502|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL||6 weeks (43 days) after vaccination 1|The analysis population is participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.|||Percentage of participants|||Number
1332167|NCT02062450|Primary|Implant Survivorship|Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.|2-year postoperative||||percentage of implants|||Number
1332168|NCT02062450|Secondary|Clinical Performance - HARRIS Score|The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered “excellent”, between 80 and 90 “good”, between 70 and 80 “mediocre” and less than 70 “poor”.|2-year postoperative||||percentage of partipants|||Number
1332169|NCT02062450|Secondary|Clinical Performance - HOOS Score|The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.|2 years postoperative||||units on a scale of 100||Standard Deviation|Mean
1332170|NCT02062450|Secondary|Clinical Performance - PMA Score|"Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician.~It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) :~a score between 15 and 18 points is defined as good,~a score between 12 and 14 points is defined as average,~a score inferior to 12 is defined as bad"|2 years postoperative||||units on a scale||Standard Deviation|Mean
1332171|NCT02062450|Primary|Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative||||percentage of participants|||Number
1332172|NCT02062450|Primary|Number of Participants With an Implant Dislocation After Surgery|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative|2 implants dislocations were reported in the 379 patients making up the Total Safety Population, of which 1 concerned a Primary surgery and the other concerned a Revision surgery. In both cases, orthopaedic reduction was performed without changing the implant.|||participants|||Number
1332200|NCT02061969|Secondary|Total Number of Hospital Visits|Total number of hospital visits during the study period|6 months||||visits|||Number
1332173|NCT02062437|Other Pre-specified|General Performance: Radiological Assessment.|"Radiological assessment is based on :~Cup radiological signs of osteolysis or radiolucencies.~Stem radiological signs of osteolysis or radiolucencies.~Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification)~Other Radiological signs"|2-year Follow-up visit|Patients with X-ray data available|||participants|||Number
1332174|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|2-year follow-up visit|Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.|||score on a scale||Standard Deviation|Mean
1332175|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).~Normal values (usually observed range of motions) are:~extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).~Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|2-year Follow-up visit|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities|||Degrees||Standard Deviation|Mean
1332176|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|Baseline|Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.|||score on a scale||Standard Deviation|Mean
1332177|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).~Normal values (usually observed range of motions) are:~extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).~Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|Baseline|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities|||Degrees||Standard Deviation|Mean
1332178|NCT02062437|Primary|Number of Participants With Adverse Events|"Surgical incidents.~Post-operative complications.~Failure and revisions analysis."|2-year follow-up visit|The total of 80 patients were seen for their 2-Year follow-up visit.|||participants|||Number
1332179|NCT02062385|Secondary|Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens|The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers >=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers >=0.1 IU/mL, 3) antipertussis toxin antibody titers >=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers >=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI.|Baseline and between 28 and 51 days after the third DTaP vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.|||Percentage of participants||95% Confidence Interval|Number
1332180|NCT02062385|Secondary|Percentage of Participants With Any Adverse Event|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor’s product, is also an adverse event.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up|||Percentage of participants|||Number
1332181|NCT02062385|Secondary|Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3|The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer >=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV.|Baseline and between 28 and 56 days after the third OPV vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.|||Percentage of participants||95% Confidence Interval|Number
1332182|NCT02062385|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis|The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as >=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.|||Participants|||Number
1332183|NCT02062385|Secondary|Percentage of Participants With Intussusception|Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed.|Up to 15 months|All Subjects as Treated with safety follow-up|||Percentage of participants|||Number
1332201|NCT02061969|Secondary|Total Number of Emergency Room Visits|Total number of emergency room visits during the study period|6 months||||visits|||Number
1332184|NCT02062385|Secondary|Percentage of Participants With Vomiting or Diarrhea|Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up|||Percentage of participants|||Number
1332185|NCT02062385|Secondary|Percentage of Participants With Elevated Temperature|Elevated temperature (temperature >=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature >=37.5 °C or an adverse event of pyrexia was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with follow-up specific to the endpoint|||Percentage of participants|||Number
1332186|NCT02062385|Primary|Number of Participants With Any Severity of Rotavirus Gastroenteritis|The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.|||Participants|||Number
1332187|NCT02062359|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 months||||participants|||Number
1332188|NCT02062359|Secondary|Persistence of Genetically Engineered, Adoptively Transferred Cluster of Differentiation 62L (CD62L) + Derived Lymphocytes|Estimate the persistence of cells via enzyme linked immunosorbent spot (ELISPOT) and tetramer analysis by fluorescence activated cell sorting (FACS).|3 months|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 22 subjects was needed to perform an analysis.||||||
1332189|NCT02062359|Primary|Objective Response (Complete Response (CR) + Partial Response (PR)) of Melanoma Tumors|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 months|None of the participants achieved a complete response or partial response and no data were collected for this assessment.||||||
1332190|NCT02062294|Secondary|Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|6 months|Safety Analysis population (SAP) comprised all 14 participants which entered study.|||participants|||Number
1332191|NCT02062294|Primary|Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis|Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.|6 months|Per Protocol (PP) population comprised all 14 participants receiving Valganciclovir within 10 days post-transplantation for at least 70 days and for whom source data from the time period between liver transplantation until 6 months post-transplantation was available.|||participants|||Number
1332192|NCT02062177|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)|one day|||||||
1332193|NCT02062177|Secondary|Time (Minutes) to Dischargeability of Patient From Endoscopic Unit|After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.|one day|||||||
1332194|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure|Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)|at 24-72 hours after procedure||||units on a scale||Standard Deviation|Mean
1332195|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge|When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)|before discharge||||units on a scale||Standard Deviation|Mean
1332196|NCT02062177|Primary|Endoscopist's Satisfaction (Visual Analog Scale) About Sedation|Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist|at the end of the exam||||units on a scale||Standard Deviation|Mean
1332197|NCT02061969|Secondary|Mortality|Mortality is defined as death occurring during admission at the LTC facility|over 6 months||||Participants|||Count of Participants
1332198|NCT02061969|Secondary|Incidence of Acute Kidney Injury|Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy|over 6 months||||events|||Number
1332209|NCT02061748|Secondary|All-cause Death (Post-hoc Analysis)|"This outcome measure describes the incidence of death for dabigatran and warfarin in the post-hoc analysis.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332210|NCT02061748|Secondary|All-cause Death (Primary Analysis)|This outcome measure describes the incidence of death for dabigatran and warfarin in the primary analysis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332211|NCT02061748|Secondary|Pulmonary Embolism (Post-hoc Analysis)|"This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the post-hoc analysis.~Pulmonary embolism includes acute pulmonary heart disease. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332212|NCT02061748|Secondary|Pulmonary Embolism (Primary Analysis)|This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the primary analysis. Pulmonary embolism includes acute pulmonary heart disease. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332213|NCT02061748|Secondary|Deep Vein Thrombosis (Post-hoc Analysis)|"This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the post-hoc analysis.~Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332214|NCT02061748|Secondary|Deep Vein Thrombosis (Primary Analysis)|This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the primary analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332215|NCT02061748|Secondary|Venous Thromboembolism (Post-hoc Analysis)|"This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the post-hoc analysis.~Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332216|NCT02061748|Secondary|Venous Thromboembolism (Primary Analysis)|"This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the primary analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332253|NCT02061683|Secondary|Percentage of Patients With an Adverse Event of Conjunctival Hyperemia|Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|3 Months|Safety population defined as all enrolled patients who completed at least 1 follow-up visit|||Percentage of Patients|||Number
1332217|NCT02061748|Secondary|MI (Post-hoc Analysis)|"This outcome measure describes the incidence of MI for dabigatran and warfarin in the post-hoc analysis.~MI includes the acute myocardial infarction. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332218|NCT02061748|Secondary|Myocardial Infarction (MI) (Primary Analysis)|This outcome measure describes the incidence of MI for dabigatran and warfarin in the primary analysis. MI includes the acute myocardial infarction. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332219|NCT02061748|Secondary|TIA (Post-hoc Analysis)|"This outcome measure describes the incidence of TIA for dabigatran and warfarin in the post-hoc analysis.~TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332220|NCT02061748|Secondary|Transient Ischemic Attack (TIA) (Primary Analysis)|"This outcome measure describes the incidence of TIA for dabigatran and warfarin in the primary analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332221|NCT02061748|Secondary|Other Major Bleeds (Post-hoc Analysis)|"This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the post-hoc analysis.~Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332222|NCT02061748|Secondary|Other Major Bleeds (Primary Analysis)|"This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the primary analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332223|NCT02061748|Secondary|Major Urogenital Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the post-hoc analysis.~Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332224|NCT02061748|Secondary|Major Urogenital Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the primary analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332276|NCT02061358|Primary|Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group|Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||participants|||Number
1332225|NCT02061748|Secondary|Major Lower GI Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the post-hoc analysis.~Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332226|NCT02061748|Secondary|Major Lower GI Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the primary analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332227|NCT02061748|Secondary|Major Upper GI Bleeding (Post-hoc Analysis)|This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major upper GI bleeding includes acute, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without (w/wo) obstruction and with hemorrhage and perforation w/wo obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. This was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332228|NCT02061748|Secondary|Major Upper GI Bleeding (Primary Analysis)|This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the primary analysis. Major upper GI bleeding includes acute gastric ulcer, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute gastrojejunal ulcer, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without obstruction and with hemorrhage and perforation with/without obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332229|NCT02061748|Secondary|Major GI Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332230|NCT02061748|Secondary|Major GI Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the primary analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332231|NCT02061748|Secondary|Major Extracranial Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332232|NCT02061748|Secondary|Major Extracranial Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the primary analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332233|NCT02061748|Secondary|Major Intracranial Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332234|NCT02061748|Secondary|Major Intracranial Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the primary analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332235|NCT02061748|Secondary|Hemorrhagic Stroke (Post-hoc Analysis)|"This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the post-hoc analysis. Hemorrhagic stroke includes: Subarachnoid hemorrhage and intracerebral hemorrhage but excludes these codes if “traumatic brain injury” or “rehabilitation care” as primary code is present.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332236|NCT02061748|Secondary|Hemorrhagic Stroke (Primary Analysis)|"This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the primary analysis. Hemorrhagic stroke includes: subarachnoid hemorrhage, intracerebral hemorrhage but excludes these codes if “traumatic brain injury” or “rehabilitation care” as primary code is present.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332237|NCT02061748|Secondary|Ischemic Stroke (Post-hoc Analysis)|"This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the post-hoc analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332238|NCT02061748|Secondary|Ischemic Stroke (Primary Analysis)|"This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332239|NCT02061748|Primary|Major Bleeding (Post-hoc Analysis)|This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332240|NCT02061748|Primary|Major Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis.~Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332241|NCT02061748|Primary|Stroke (Post-hoc Analysis)|This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332242|NCT02061748|Primary|Stroke (Primary Analysis)|"This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis.~Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.~Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if “traumatic brain injury” or “rehabilitation care” is present.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
1332243|NCT02061696|Secondary|Pain Score||Up to 37 days post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332244|NCT02061696|Secondary|Patient Satisfaction|Assessed by a patient satisfaction questionnaire.|Up to 37 days post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332245|NCT02061696|Secondary|Minor Access Site Related Complications|Observation of any minor access site related complications.|Up to 37 days post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332246|NCT02061696|Secondary|Ability to Sit up at 45-degree Angle|The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.|15 minutes of successful hemostasis|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332247|NCT02061696|Secondary|Time to Ambulation|Time from sheath removal until the participant can stand or walk 20 feet without rebleeding. Ambulation can be evaluated at 1,2, and 4 hours post sheath removal until the participant can ambulate.|Up to 1 day post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332248|NCT02061696|Secondary|Time to Actual Discharge|Time following procedural sheath removal until actual discharge.|Up to 1 day post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332249|NCT02061696|Secondary|Time to Discharge Eligibility|The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.|Up to 1 day post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332250|NCT02061696|Secondary|Time to Hemostasis|Difference between the time the procedural sheath is removed and hemostasis is observed.|From procedural sheath removal until hemostasis is achieved.|Data not analyzed as the test device became unavailable and the study was terminated.||||||
1332251|NCT02061696|Secondary|AXERA 2 Access System Success|Achievement of femoral artery access with AXERA and placement of procedural sheath.|At the time of the femoral artey access procedure up to 1 hour post procedure|Data was not analyzed as the device became unavailable and the study was terminated.||||||
1332252|NCT02061696|Primary|Number of Participants With Any Site-Related Major Adverse Events|Observation of any major access site related complications (number of participants).|Up to 37 days post procedure||||Participants|||Count of Participants
1332660|NCT02056639|Secondary|Number of Participants That Experienced Neonatal Death|Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.|Between birth and 28 days of age||||Participants|||Count of Participants
1332254|NCT02061683|Primary|Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).|Month 3|All enrolled patients with data available for analysis|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1332255|NCT02061592|Primary|Monocular logMar Visual Acuity - Standard Low Contrast Bright|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1- week Follow-up|Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.|||LogMar|Eyes|Standard Deviation|Mean
1332256|NCT02061592|Primary|Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1-week follow-up|Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.|||LogMar|Eyes|Standard Deviation|Mean
1332257|NCT02061592|Primary|Overall Vision|Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1- week Follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.|||units on a scale||Standard Deviation|Mean
1332258|NCT02061592|Primary|Overall Comfort|Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1-week follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.|||units on a scale||Standard Deviation|Mean
1332259|NCT02061540|Other Pre-specified|Change From Baseline for Other Biochemical Markers of Cholestasis: Total Cholesterol, Low Density Lipoprotein Cholesterol|Total cholesterol (TC) level and low density lipoprotein cholesterol (LDLC) level were considered as biochemical markers of cholestasis.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||mg/dL||Standard Deviation|Mean
1332260|NCT02061540|Secondary|Change From Baseline in Pruritus as Measured by Adult Itch Reported Outcome (ItchRO) Weekly Sum Score|The Adult ItchRO instrument was completed twice daily using an electronic diary (eDiary). Each morning and evening score had a range from 0-10, with the higher score indicating increasing itch severity. The following was used for assessing the Adult ItchRO daily score: The score which represented the most severe itching for the day (morning or evening) was taken for each day as the daily score (maximum daily score of 10); If only 1 of the 2 scores was available for the day, the score that was available was used as the daily score; If both the morning and the evening scores were missing, the score was considered missing for the day.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||units on scale||Standard Deviation|Mean
1332261|NCT02061540|Secondary|Change From Baseline in Bilirubin Levels at Week 14|Total Bilirubin and Direct (Conjugated) Bilirubin levels were evaluated.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1332262|NCT02061540|Secondary|Change From Baseline in Liver Enzyme Levels in Serum|Levels of liver enzymes such as Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in serum were evaluated.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||units per liter (U/L)||Standard Deviation|Mean
1332263|NCT02061540|Primary|Change From Baseline in Fasting Serum Bile Acid Level at Week 14|Serum bile acid levels were evaluated using blood samples collected.|Baseline, Week 14|Modified intent-to-treat (mITT) population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||micromoles per liter||Standard Deviation|Mean
1332264|NCT02061540|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. TEAEs were AEs with a start date on or after the first dose of investigational product and started prior to the last dose of investigational product plus 14 days.|From start of study drug administration until Week 18|Safety population included all participants who received at least 1 dose of the investigational product.|||participant|||Number
1332661|NCT02056639|Secondary|Spontaneous Preterm Birth Rates||Less than 37 weeks gestation||||Participants|||Count of Participants
1332265|NCT02061358|Secondary|CLr by Treatment Group: UV-4|CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing.L/h|||L/h||Geometric Coefficient of Variation|Geometric Mean
1332266|NCT02061358|Secondary|Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group|fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||percentage of dose||Standard Deviation|Mean
1332267|NCT02061358|Secondary|Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group|Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.|||mg||Standard Deviation|Mean
1332268|NCT02061358|Secondary|t(1/2) by Treatment Group: UV-4|t(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||hours||Full Range|Median
1332269|NCT02061358|Secondary|Vz/F by Treatment Group: UV-4|Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by [λ(z) × AUC(0-inf)].|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||L||Geometric Coefficient of Variation|Geometric Mean
1332270|NCT02061358|Secondary|CL/F by Treatment Group: UV-4|CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1332271|NCT02061358|Secondary|AUC(0-inf) by Treatment Group: UV-4|AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.|||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
1332272|NCT02061358|Secondary|AUC(0-last) by Treatment Group: UV-4|AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
1332273|NCT02061358|Secondary|Tmax by Treatment Group: UV-4|Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||hours||Full Range|Median
1332274|NCT02061358|Secondary|Cmax by Treatment Group: UV-4|Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332275|NCT02061358|Primary|Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group|Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.|Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Participants|||Number
1332662|NCT02056639|Secondary|Average Birth Weight of Babies in Each Group|The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.|Time of delivery||||grams||Full Range|Mean
1332277|NCT02061358|Primary|Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)|Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Participants|||Number
1332278|NCT02061358|Primary|Subjects With Serious Adverse Event (SAEs) by Treatment Group|Subjects with AEs considered serious by the investigator|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Subjects with at least 1 SAE|||Number
1332279|NCT02061358|Primary|Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group|TEAEs are those AEs occurring only after administration of investigational product|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Subjects with at least 1 TEAE|||Number
1332280|NCT02061280|Secondary|Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 6, week 12) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Final Visit (Visit 6, Week12)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. Thus, the caregiver did not complete the Research Participant Assessment at Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
1332281|NCT02061280|Secondary|Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 6, week 12) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Final Visit (Visit 6, Week12)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
1332282|NCT02061280|Primary|Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Screening (Visit 1, week -8)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. Thus, the caregiver did not complete the Research Participant Assessment at Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
1332283|NCT02061280|Primary|Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Screening (Visit 1, week -8)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
1332284|NCT02060890|Other Pre-specified|Number of Participants Reaching 12 Months Progression Free Survival|Treatment efficacy derived from specialized Tumor Board suggestion, defined by 12 month progression free survival.|12 month progression free survival|Number of patients who chose to pursue treatment based on genomic informed recommendations|||Participants|||Count of Participants
1332285|NCT02060890|Other Pre-specified|Successful Generation of Patient-derived Xenograft (PDX) Genomic Models|Number of patient-derived xenograft (PDX) models successfully derived from patient tumor samples.|Within 12 months after tissue collection|Nine patients had sufficient tissue sent for PDX model development.|||Participants|||Count of Participants
1332286|NCT02060890|Other Pre-specified|Tumor Markers vs. Treatment Response|Frequency with which unique tumor markers can be detected in the blood circulation and correlation with disease burden and response. Plasma samples were collected for circulating tumor DNA (ctDNA) analysis for all 16 patients. Analysis of these samples is underway.|12 months||2018-02-28|02/2018||||
1332287|NCT02060890|Secondary|Number of Patients Who Chose to Pursue Treatment|Number of patients who chose to pursue treatment based on these genomics-informed treatment recommendations|Within 35 days from surgery to making genomic informed treatment recommendation||||Participants|||Count of Participants
1332310|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||percentage of participants|||Number
1332288|NCT02060890|Primary|Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery|To demonstrate feasibility, we would want the treatment recommendation to be fully complete within 35 calendar days in at least 85% of patients for which sufficient RNA and DNA is available.|35 days from surgery to making genomic informed treatment recommendation|16 pts had tumor tissue for analysis; 15 of 16 patients received treatment recommendations within 35 days of surgery.|||Participants|||Count of Participants
1332289|NCT02060838|Primary|Time to Platelet Aggregation as Measured Using Collagen–Adenosine (ADP)|The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture.|Just prior to re-transfusion, assessed up to 5 minutes||||seconds||Inter-Quartile Range|Median
1332290|NCT02060838|Primary|Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)|The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture.|Just prior to re-transfusion, assessed up to 5 minutes||||seconds||Inter-Quartile Range|Median
1332291|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained at 2 weeks."|2 Weeks||||hours||Standard Deviation|Mean
1332292|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained for habitual lens at baseline."|Baseline||||hours||Standard Deviation|Mean
1332293|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.|2 Weeks|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.|||units on a scale|Eyes|Standard Deviation|Mean
1332294|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.|Baseline|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.|||units on a scale|Eyes|Standard Deviation|Mean
1332295|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.|2 Weeks||||logMar||Standard Deviation|Mean
1332296|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||logMar||Standard Deviation|Mean
1332297|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.|Baseline||||logMar||Standard Deviation|Mean
1332298|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.|2 Weeks||||units on a scale|Lenses|Standard Deviation|Mean
1332299|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale|Lenses|Standard Deviation|Mean
1332300|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.|Baseline||||units on a scale|Lenses|Standard Deviation|Mean
1332301|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.|2 Weeks||||units on a scale|Lenses|Standard Deviation|Mean
1332302|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale|Lenses|Standard Deviation|Mean
1332303|NCT02060539|Secondary|Lens Movement - Habitual Lenses|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.|Baseline||||units on a scale|Lenses|Standard Deviation|Mean
1332304|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.|2 Weeks||||percentage of lenses|Lenses||Number
1332305|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.|Dispense||||percentage of lenses|Lenses||Number
1332306|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
1332307|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||percentage of participants|||Number
1332308|NCT02060539|Primary|Handling Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
1332309|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
1332311|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
1332312|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||percentage of participants|||Number
1332313|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
1332314|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1332315|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
1332316|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 weeks||||units on a scale||Standard Deviation|Mean
1332317|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1332318|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
1332319|NCT02060539|Primary|Vision Quality (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
1332320|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1332321|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
1332322|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1332323|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
1332324|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
1332325|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1332326|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
1332327|NCT02060539|Primary|Comfort (Insertion)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
1332328|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1332329|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
1332330|NCT02060539|Primary|Dryness (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
1332331|NCT02060539|Secondary|Lens Centration - Habitual Lenses|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.|Baseline||||percentage of lenses|Lenses||Number
1332332|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1332333|NCT02060526|Secondary|Maximum Observed Drug Concentration (Cmax) of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Serum|Cmax of rhHNS in serum was evaluated using enzyme-linked immunosorbent assay (ELISA) method and liquid chromatography tandem mass spectrometry (LC-MS) method.|Predose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 12 h, 24 h, and 48 h post-dose on Week 0 and Week 48|Pharmacokinetic (PK) population included all participants who received HGT-1410, participated in the scheduled PK studies, and had sufficient samples available for analysis.|||ng/ml||Standard Deviation|Mean
1332334|NCT02060526|Secondary|Concentration of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Cerebrospinal Fluid (CSF)|Concentration of rhHNS in CSF was assessed using validated enzyme-linked immunosorbent assay (ELISA) method.|Pre-dose, 4, 48 hours on Week 0 and Week 48|Pharmacokinetic (PK) population included all participants who received HGT-1410, participated in the scheduled PK studies, and had sufficient samples available for analysis.|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
1332335|NCT02060526|Secondary|Change From Baseline in Concentration of GAG in Urine at Week 48|The concentration of GAG in urine was normalized to the urine creatinine value and reported as milligram (mg) GAG per millimole (mmol) creatinine.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||mg GAG/mmol creatinine||Standard Deviation|Mean
1332336|NCT02060526|Secondary|Change From Baseline in Concentration of Glycosaminoglycan (GAG) in Cerebrospinal Fluid (CSF) at Week 48|Change from baseline in concentration of GAG in CSF at Week 48 was reported.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||micromolar||Standard Deviation|Mean
1332337|NCT02060526|Secondary|Change From Baseline in Total Cortical Grey Matter Volume at Week 48|The change from baseline in grey matter volume at Week 48 was assessed by magnetic resonance imaging (MRI).|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||cubic centimeter (cc)||Standard Deviation|Mean
1332338|NCT02060526|Secondary|Change From Baseline in Development Quotient (DQ) Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III) at Week 48|The BSID-­III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The DQ is a means to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID-­III DQ score is based on the cognitive domain. A positive value indicates improvement in health and cognition.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||percentage of chronological age||Standard Deviation|Mean
1332339|NCT02060526|Secondary|Change From Baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II) Development Quotient (DQ) Score at Week 48|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). A positive value indicates improvement in health and cognition.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||percentage of chronological age||Standard Deviation|Mean
1332340|NCT02060526|Secondary|Number of Participants With Positive Anti-recombinant Human Heparan-N-Sulfatase (rhHNS) Antibody in Serum at Week 48|A participant was considered positive if they had at least 1 positive result during the study. Once a participant reported antibody positive, they were considered positive for the remainder of the study.|Baseline (Week 0) up to Week 48|Safety population included all participants who received a dose of HGT-1410 using either the IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety followup data.|||participants|||Number
1332341|NCT02060526|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product related. This included an exacerbation of a pre-existing condition. TEAEs were defined as AE occurring on or after the time of first IDDD implantation or LP procedure to the end of study (EOS) visit (+30 days).|Baseline (Week 0) up to Week 52|Safety population included all participants who received a dose of HGT-1410 using the IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety follow-up data.|||participants|||Number
1332342|NCT02060526|Secondary|Number of Participants With Serious Adverse Events (SAE)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product related. This included an exacerbation of a pre-existing condition. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline (Week 0) up to Week 52|Safety population included all participants who received a dose of HGT-1410 either using IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety follow-up data.|||participants|||Number
1332356|NCT02059395|Primary|Skill Retention Estimated From the Change of AHA Heartsaver Total Score From Immediate Post-test to Retention Test|The official AHA Heartsave adult CPR AED Skill Sheet checklist for single-rescuer BLS was used to capture participants' skills for single-rescuer BLS and defibrillation with an AED. The AHA Heartsaver checklist has 11 action items, participant receives 1 point when an action on the checklist is performed. Therefore, the total score range from 0-11, with higher values represent a better outcome. Immediate post-test and retention test skill performance were evaluated by 2 independent raters. Skill retention was estimated by calculating the change in score from immediate post-test to retention test.|Baseline and 4 months||||units on a scale||Full Range|Mean
1332343|NCT02060526|Primary|Number of Participants With Overall Response Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III)|The BSID-­III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The development quotient (DQ) is a means to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID-­III DQ score is based on the cognitive domain. A positive value indicates improvement in health and cognition. Overall response was the maximum decline in the DQ of 10 points or less over 48 weeks. Number of participants with the overall response were reported here.|Baseline (Week 0) up to Week 48|ITT population included all randomized participants.|||participants|||Number
1332344|NCT02060461|Primary|Evaluation of LASIK Flap Thickness|Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.|3 months|Contralateral eyes|||micrometers|eyes|Standard Deviation|Mean
1332345|NCT02060058|Other Pre-specified|The Other Responses in the mITT Population/Safty- HBV Virologic Response|HBV virologic response, defined as serum HBV DNA levels to < 200 IU/mL at follow-up week 24 among patients with detectable HBV DNA at baseline|week 24||||participants|||Number
1332346|NCT02060058|Secondary|Key Secondary Endpoint of This Clinical Trial-SVR in mITT|The total 7 patients had SVR by mITT in this clincial-trial, which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of Boceprevir|week 24|MITT population included subjects receiving ≥ 1 dose of boceprevir.|||participants|||Number
1332347|NCT02060058|Primary|Number of Full Analysis Set Participants Who Received HCV Anti-viral Therapy With Sustained Virological Response (SVR)|The methods used to assess this outcome measure is by full-analysis set (FAS), which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of any antiviral medication (Boceprevir/peginterferon/ribavirin)|week 24|"For survey the total 12 chronic hepatitis C patients by FAS in different arms in this clinical- trial.~Outcome Measure Data Table: For survey the total 8 chronic hepatitis C patients had SVR by FAS in different arms in this clinical- trial."|||participants|||Number
1332348|NCT02059993|Primary|Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment||baseline and follow-up at 36 months|4 participants withdrew before the end of study. Two subjects were lost to follow-up in the control group, and 4 patients (all of them had no SCCE) with very poor CPAP compliance were also excluded.|||mm Hg||Standard Deviation|Mean
1332349|NCT02059993|Other Pre-specified|Cardiovascular and Cerebrovascular Events||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month|||||||
1332350|NCT02059993|Secondary|Change in Epworth Sleepiness Scale (ESS)||1 month，3 month，6 month，12 month，18 month，24 month，30 month，36 month|||||||
1332351|NCT02059993|Secondary|Change in Glucose and Lipid Metabolism||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month|||||||
1332352|NCT02059928|Primary|Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure|External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated.|Up to 12 hour data collection period|Inclusion criteria included: age ≥ 18 year old, presence of an IO placed by EMS or in the Emergency Department, and planned admission to the Medical or Surgical Intensive Care Unit. Patients were excluded if they had anticipated surgery within 12 hours of IO placement, ongoing infection at the placement site.|||percentage of IO pressure to cuff pressu|||Number
1332353|NCT02059902|Primary|Narcotic Consumption (Measured in mg/kg Narcotic Consumption)|The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution.|24-hours post surgery||||mg/kg narcotic consumption||Inter-Quartile Range|Median
1332354|NCT02059642|Secondary|Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events|Safety assessments will be based on changes from Baseline of clinical AEs reported by the subject or observed by the Investigator and concomitant medication use, treatment adherence (eg, dropouts due to AEs)|6 weeks|Safety population|||Percentage of participants with TEAEs|||Number
1332355|NCT02059642|Primary|Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks|Primary efficacy endpoint: change from Baseline in the total ADHD symptom score with adult prompts of the CAARS-Inv. The CAARS is a scale to assess the presence and severity of ADHD symptoms and behaviors in adults. During an interview with the investigator, subject rates items pertaining to their behavior using a 4-point Likert-style format ranging from 0 (‘Not at all’) to 3 (‘Very much). The scale measures ADHD symptoms across clinically significant domains using a 30 item questionnaire, while examining the manifestations of those symptoms. The scale includes an assessment of 9 inattentive symptoms (Subset A) and 9 hyperactive & impulsive symptoms (Subset B). The total ADHD symptom score, Subset C (the sum of the inattentive symptom scores from Subset A and the hyperactive & impulsive symptoms from Subset B) is the primary outcome measure. Scores of the scale for Subset C, comprised of scores from 18 questions,range from 0 (no ADHD symptoms) to 54, highest rating of ADHD symptoms.|baseline, 6 weeks|Intent to Treat|||Change in Score from Baseline||95% Confidence Interval|Least Squares Mean
1332357|NCT02059291|Secondary|Percentage of Participants of Canakinumab Responders From Epoch 2 Who Maintained a Clinically Meaningful Response (Absence of New Flares) (40 Weeks)|A responder was defined as a participant who had no flare between week 16 and week 40.|40 weeks|The re-randomized set was analyzed.|||Percentage of participants|||Number
1332663|NCT02056639|Primary|Number of Participants With Preterm Delivery||Less than 34 weeks gestation||||Participants|||Count of Participants
1332358|NCT02059291|Secondary|Percentage of Participants With Normalized Serum Amyloid A (SAA) Level|Normalized SAA was defined as SAA <= 10 mg/L.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
1332359|NCT02059291|Secondary|Percentage of Participants With the Serologic Remission|Serologic remission was defined as C-reactive protein <= 10 mg/L.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
1332360|NCT02059291|Secondary|Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2|The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
1332361|NCT02059291|Primary|Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks)|Resolution of the initial disease flare is defined as: Physician's Global Assessment of Disease activity (PGA) <2 and C-reactive protein (CRP) within normal range (<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
1332362|NCT02059278|Secondary|Mean Deviation in Visual Field|Visual Field was performed using an automated perimeter according to the sites standard protocol. This test measures the angle of the visual field from the central visual axis. Visual Field Testing generates a numerical scale as its main result which shows the retinal sensitivities at the different test locations, expressed in Decibels (dB). The mean deviation in the visual field reflects the overall depression (deviation from normal values). Negative values indicate a reduction in visual field. The analysis performed is the mean change from baseline at Day 84.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||Decibels (dB)||Standard Deviation|Mean
1332363|NCT02059278|Secondary|Ophthalmoscopy|Number of participants with eye abnormalities following ophthalmoscopy. Direct ophthalmoscopy with dilation included assessment of the optic nerve head for pallor and cupping. A dilated fundus examination consisting of the vitreous, optic nerve, macula, and peripheral retina was conducted. Results are reported as the number of subjects with clinical significant abnormalities at Day 84 that were not clinically significant at Baseline.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||Participants|||Count of Participants
1332364|NCT02059278|Secondary|Slit Lamp Examination|Number of participants with eye abnormalities following routine slit lamp examination. The anterior segment of the eye including lids, cornea, conjunctiva, anterior chamber, iris and lens were evaluated with a routine slit lamp examination and any abnormalities observed were reported.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||Participants|||Count of Participants
1332365|NCT02059278|Secondary|Visual Acuity|Visual Acuity was measured using the Corrected Snellen Visual Acuity method reported as the Logarithm Minimum Angle of Resoution (logMAR) change from baseline. The Snellen eye chart was used with the subject's current corrected lens prescription at a distance equivalent to 20 feet. Results from the Snellen chart were converted to the logMAR scale which is the standard tool for reporting visual acuity outcomes.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||logMAR units||Standard Deviation|Mean
1332366|NCT02059278|Primary|Intraocular Pressure|"Evaluation of intraocular pressure using Goldmann applanation tonometry.~Primary outcome was the between group difference in the change from baseline in IOP at each of 9 assessment points.~Equivalence was achieved if the 95% Confidence Intervals were within 1.5 mmHg at all 9 time points"|Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84|The Per Protocol population was the primary efficacy population and consisted of those subjects in the ITT population who had no major protocol violations and no missing data points|||mm Hg||Standard Deviation|Mean
1332367|NCT02059187|Secondary|Percentage of Participants With Hemoglobin A1C <6.5% at Week 24|Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24.|Week 24|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.|||Percentage of participants|||Number
1332368|NCT02059187|Secondary|Percentage of Participants With Hemoglobin A1C <7% at Week 24|Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24.|Week 24|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.|||Percentage of participants|||Number
1332369|NCT02059187|Secondary|Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24|7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1332370|NCT02059187|Secondary|Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24|Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1332973|NCT02046382|Other Pre-specified|Total Amount of Ibuprofen During Inpatient Stay|Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.|2-7 days||||mg||Standard Deviation|Mean
1332371|NCT02059187|Secondary|Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24|Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
1332372|NCT02059187|Secondary|Daily Basal Insulin Dose (Units) at Week 24|The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
1332373|NCT02059187|Secondary|Percentage of Participants Experiencing an AE Over the 24-week Treatment Period|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE.|Up to 24 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1332374|NCT02059187|Secondary|Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24|Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels </= 70mg/dL (</= 3.9mmol/L) could also be reported as adverse events at the discretion of the investigator.|Up to 24 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1332375|NCT02059187|Secondary|Change From Baseline in Participant Body Weight at Week 24|Change from baseline in participant body weight at Week 24.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||kilograms||Standard Deviation|Mean
1332376|NCT02059187|Primary|Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24|Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.|Up to 24 weeks|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percentage of participants|||Number
1332377|NCT02059187|Primary|Change From Baseline in Participant Hemoglobin A1C Level at Week 24|A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percent A1C||95% Confidence Interval|Least Squares Mean
1332378|NCT02059174|Secondary|M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the Second 12 Hours After Dosing (AUC12-24)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC12-24 is a measure of the total amount of drug in the plasma from Hour 12 to Hour 24. Analysis was performed on log scale with results back transformed to original scale.|From 12 to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg∙hr/mL||95% Confidence Interval|Geometric Mean
1332379|NCT02059174|Secondary|M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the First 12 Hours After Dosing (AUC0-12)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-12 is a measure of the total amount of drug in the plasma from the dose to Hour 12. Analysis was performed on log scale with results back transformed to original scale.|Up to 12 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg∙hr/mL||95% Confidence Interval|Geometric Mean
1332380|NCT02059174|Primary|M1 Glargine Metabolite PK: Maximum Plasma Concentration (Cmax)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Analysis was performed on log scale with results back transformed to original scale.|Up to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg/mL||95% Confidence Interval|Geometric Mean
1332381|NCT02059174|Primary|M1 Glargine Metabolite Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC0-24)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Analysis was performed on log scale with results back transformed to the original scale|Up to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg∙hr/mL||95% Confidence Interval|Geometric Mean
1332382|NCT02059174|Primary|PD: Maximum Glucose Infusion Rate (GIRmax)|Maximum glucose infusion rate (GIR[max]) based on smoothed data for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 30 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).|||mg/kg/min||95% Confidence Interval|Mean
1332383|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the Second 12 Hours After Dosing (GIR-AUC12-24hr)|The area under the glucose infusion rate curve from hours 12 to 24 after injection (AUC[GIR{12-24}]) for participants who received either MK-1293 or Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|From 12 to 24 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).|||mg/kg||95% Confidence Interval|Mean
1332384|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the First 12 Hours After Dosing (GIR-AUC0-12hr)|The area under the glucose infusion rate curve from hours 0 to 12 after injection (AUC[GIR{0-12}]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 12 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||mg/kg||95% Confidence Interval|Mean
1332385|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over 24 Hours After Dosing (GIR-AUC0-24hr)|The area under the glucose infusion rate curve from hours 0 to 24 after injection (AUC[GIR{0-24}]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 24 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).|||mg/kg||95% Confidence Interval|Mean
1332386|NCT02059174|Primary|Comparison of MK-1293 and EU-Approved Lantus Duration of Pharmacodynamic Action During a 30-Hour Euglycemic Clamp Study|Duration of Action (DOA) is defined as the length of time from dosing to End of Action. End of Action is defined as the time point at which plasma glucose has been above 150 mg/dL for 30 minutes and no glucose has been infused for 30 minutes. Median and max below are reported for the length of clamp duration (i.e. 30 hours).|Up to 30 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||Hours||Full Range|Median
1332387|NCT02059161|Secondary|Bolus Insulin Dose Per kg of Body Weight at Week 24|Bolus Insulin Dose per kg of Body Weight at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
1332388|NCT02059161|Secondary|Bolus Insulin Dose at Week 24|Bolus Insulin Dose at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
1332389|NCT02059161|Secondary|Basal Insulin Dose Per kg of Body Weight at Week 24|Basal Insulin Dose per kg of Body Weight at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
1332390|NCT02059161|Secondary|Basal Insulin Dose at Week 24|Basal Insulin Dose at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
1332391|NCT02059161|Secondary|Bolus Insulin Dose Per kg of Body Weight at Week 52|Bolus Insulin Dose per kg of Body Weight at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
1332392|NCT02059161|Secondary|Bolus Insulin Dose at Week 52|Bolus Insulin Dose at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
1332393|NCT02059161|Secondary|Basal Insulin Dose Per kg of Body Weight at Week 52|Basal Insulin Dose per kg of Body Weight at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
1332394|NCT02059161|Secondary|Basal Insulin Dose at Week 52|Basal Insulin Dose at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
1332395|NCT02059161|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.|Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment.|52 weeks|The analysis population included all randomized, treated participants with a Week 52 A1C measurement.|||Percentage of participants|||Number
1332396|NCT02059161|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.|Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment.|24 weeks|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.|||Percentage of participants|||Number
1332397|NCT02059161|Secondary|Change From Baseline in 7-point SMBG at Week 52|The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1332974|NCT02046382|Secondary|Length of Stay|Length of hospital stay (admission to discharge) will be collected.|2-7 days||||hours||Inter-Quartile Range|Median
1332398|NCT02059161|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24|The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1332399|NCT02059161|Secondary|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment.|Up to Week 52|The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 52.|||Percentage of participants|||Number
1332400|NCT02059161|Secondary|Change From Baseline in FPG at Week 52|Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1332401|NCT02059161|Secondary|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units/kg.||95% Confidence Interval|Least Squares Mean
1332402|NCT02059161|Secondary|Total Insulin Dose at Week 52|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units||95% Confidence Interval|Least Squares Mean
1332403|NCT02059161|Secondary|Change From Baseline in AIA Titer After 52 Weeks of Treatment|This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0.|Baseline and Week 52|The analysis population included all randomized, treated participants who had AIA data at baseline and Week 52.|||AIA Titers||Standard Deviation|Mean
1332404|NCT02059161|Secondary|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52|Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline.|Up to Week 52|The analysis population included all randomized, treated participants who had data for AIA at baseline and Week 52.|||Percentage of participants|||Number
1332405|NCT02059161|Secondary|Percentage of Participants With Confirmed Positive AIA Up Through Week 52|Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline.|Up to Week 52 including baseline|The analysis population included all randomized, treated participants who had data for AIA at or before Week 52.|||Percentage of participants|||Number
1332406|NCT02059161|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1332407|NCT02059161|Secondary|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units/kg.||95% Confidence Interval|Least Squares Mean
1332408|NCT02059161|Secondary|Total Insulin Dose at Week 24|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units||95% Confidence Interval|Least Squares Mean
1332409|NCT02059161|Secondary|Change From Baseline in A1C at Week 52|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percent||95% Confidence Interval|Least Squares Mean
1332410|NCT02059161|Primary|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment.|Up to Week 24|The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 24.|||Percentage of participants|||Number
1332411|NCT02059161|Primary|Change From Baseline in AIA Titer After 24 Weeks of Treatment|This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer.|Baseline and Week 24|The analysis population included all randomized, treated participants who had AIA data at baseline and Week 24.|||AIA Titers||Standard Deviation|Mean
1332412|NCT02059161|Primary|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24|Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.|Up to Week 24|The analysis population included all randomized, treated participants who were AIA negative at baseline and had data for AIA at or before Week 24.|||Percentage of participants|||Number
1332443|NCT02058940|Secondary|Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)|Calculated from blood pressure measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||percentage of patients|||Number
1332413|NCT02059161|Primary|Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24|Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.|Up to Week 24|The analysis population included all randomized, treated participants who had data for AIA at or before Week 24.|||Percentage of participants|||Number
1332414|NCT02059161|Primary|Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percent||95% Confidence Interval|Least Squares Mean
1332415|NCT02059148|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)|Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219.|Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1332416|NCT02059148|Secondary|Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||hour (h)||Full Range|Median
1332417|NCT02059148|Secondary|Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1332418|NCT02059148|Secondary|Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1332419|NCT02059148|Primary|Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||hour (h)||Full Range|Median
1332420|NCT02059148|Primary|Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||nanogram*hour/mL (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1332421|NCT02059148|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1332422|NCT02059135|Other Pre-specified|Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality|Maternal and fetal/neonatal outcomes of specific interest were defined in the protocol. Maternal subjects were assessed through 4-6 weeks post delivery to determine if outcomes had occurred. Neonatal outcomes were assessed from birth until 36 weeks post menstrual age, or through the 4-6 week post delivery visit (if 36 weeks PMA occurs <28 days following delivery). A second fetal/neonatal composite outcome was the avoidance of fetal/neonatal mortality and neonatal morbidity [BPD, IVH grade ≥ 3, cystic PVL, ROP stage ≥ 3, late sepsis, and NEC (Bell’s stage ≥ 2)].|Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery).|ITT|||participants|||Number
1332423|NCT02059135|Secondary|Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)|"Composite score was calculated based on the following fetal and neonatal events: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), cystic periventricular leucomalacia (PVL), retinopathy of prematurity (ROP), late Sepsis, necrotizing enterocolitis (NEC) and mortality (fetal and neonatal). The endpoint is measured on a 5 point scale where 0 represents no outcomes experienced and no mortality, and 4 represents death, as shown below. Should the same outcome occur more than once, it will only be counted once.~Score Outcome 0 No events, no mortality~One event, no mortality~Two events, no mortality~Three or more events, no mortality~Death"|Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)|ITT|||scores on a scale of 0 to 4||Standard Deviation|Mean
1332424|NCT02059135|Primary|Increase in Gestational Age in Days|Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.|Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.|ITT|||days||Full Range|Median
1332425|NCT02059070|Secondary|Post-operative Oxycodone Use (mg)|The total amount of oxycodone medication (mg) that the patient consumed in the 24 hours post surgery.|The 24 hour period following surgery||||mg||Standard Deviation|Mean
1332426|NCT02059070|Other Pre-specified|Highest Patient Pain Level|The Visual analog pain scale ranges from 0 to 10, with higher scores indicating higher pain|Within 36 hours of surgery||||VAS units on a scale||Standard Deviation|Mean
1332427|NCT02059070|Secondary|Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test|For ultrasonographic evaluation if caudad movement of the hemidiaphragm was observed, the distance was measured recorded and assigned a positive (+) value. If paradoxical cephalad movement of the diaphragm was observed, the distance was given a negative value (-). Each measurement was performed 3 times and the best value was recorded.|Within 36hrs following surgery||||percentage of baseline change||Standard Deviation|Mean
1332428|NCT02059070|Primary|Forced Expiratory Volume at 1 Second (% Change From Baseline)||Within the first 4 days following surgery||||percentage of change from baseline||Standard Deviation|Mean
1332429|NCT02059005|Secondary|Number of Hospitalizations and Use of Emergency Services|Days of hospitalization and days of use of acute emergency services after Baseline. Participants self-reported their service utilization for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported their service utilization since the last assessment date.|0, 3, 6, months|The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed.|||Days of ER or Hospital Utilization||Standard Deviation|Mean
1332430|NCT02059005|Secondary|Change in Treatment Session Attendance From Baseline|Treatment sessions attended for alcohol or drug use issues over time. Participants self-reported attendance for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported attendance since the last assessment date.|0, 3, 6, months|The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed.|||Days of attending treatment sessions||Standard Deviation|Mean
1332431|NCT02059005|Primary|Change in Substance Use Rates From Baseline|Urinalysis confirmed self-reported days of use for any substance, including alcohol, cocaine, marijuana, opiates, sedatives, and hallucinogens over time. Participants reported substance use for the 90 days prior to the assessment date.|0, 3, 6 months|The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed.|||Days of Substance Use||Standard Deviation|Mean
1332432|NCT02058992|Secondary|Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4|"PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition."|Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
1332433|NCT02058992|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||number of awakenings||Standard Deviation|Mean
1332434|NCT02058992|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||hours||Standard Deviation|Mean
1332435|NCT02058992|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||minutes||Standard Deviation|Mean
1332436|NCT02058992|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 weeks|SAS was defined as participants who were enrolled and completed the study.|||participants|||Number
1332437|NCT02058992|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator’s opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 6 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.|||participants|||Number
1332438|NCT02058940|Secondary|Median Hospital Length of Stay|Defined as the number of days admitted to the hospital|From enrollment to 30 days post study drug discontinuation||||days||Inter-Quartile Range|Median
1332439|NCT02058940|Secondary|Median Intensive Care Unit Length of Stay|Defined as the number of days admitted to the Intensive Care Unit|From enrollment to 30 days post study drug discontinuation||||days||Inter-Quartile Range|Median
1332440|NCT02058940|Secondary|Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion||24 hours|The institutional review board requested the study team limit exenatide concentration sampling to during the infusion. Samples were not collected after discontinuation of study drug. As such, this pharmacokinetic parameter is not reported.||||||
1332441|NCT02058940|Secondary|Exenatide Elimination Rate Constant After Discontinuation of Infusion||24 hours|The institutional review board requested the study team limit exenatide concentration sampling to during the infusion. Samples were not collected after discontinuation of study drug. As such, this pharmacokinetic parameter is not reported.||||||
1332442|NCT02058940|Secondary|Correlation of Exenatide Concentrations With Creatinine Clearance|Spearman's correlation coefficient calculated from exenatide concentrations and urine creatinine measurements collected for all patients during the study period. A correlation coefficient is a numerical measure of some type of correlation, meaning a statistical relationship between two variables. Spearman's correlation coefficient assumes values in the range from −1 to +1, where +1 indicates the strongest possible agreement and −1 the strongest possible disagreement.|Over 48 hours from infusion initiation||||correlation coefficient|||Number
1332975|NCT02046382|Secondary|Number of Participants With Narcotic Associated Side Effects|Only outcome for nausea/emesis is reported.|2-7 days||||Participants|||Count of Participants
1332445|NCT02058940|Secondary|Median Daily Cerebral Perfusion Pressure|Calculated from hourly measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation|No patients with an admitting diagnosis of Subarachnoid Hemorrhage received ICP or CPP monitoring as part of standard of care and therefore data is not reported.||||||
1332446|NCT02058940|Secondary|Median Daily Intracranial Pressure|Calculated from hourly measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation|No patients with an admitting diagnosis of Subarachnoid Hemorrhage received ICP or CPP monitoring as part of standard of care and therefore data is not reported.||||||
1332447|NCT02058940|Secondary|Percentage of Patients Experiencing Metabolic Crisis|Metabolic crisis is defined as cerebral microdialysate glucose concentration <0.7 mmol/L in combination with lactate pyruvate ratio >40. Calculated from hourly microdialysis samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation|No patients received invasive intracranial multimodal monitoring as a part of their standard of care, as such, these endpoints were not collected.||||||
1332448|NCT02058940|Secondary|Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)|Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||percentage of patients|||Number
1332449|NCT02058940|Secondary|Percentage of Hypoglycemic Episodes (<80 mg/dL)|Percentage of hypoglycemic episodes is calculated as the total number of glucose measurements <80 mg/dL for all patients/total number of glucose measurements collected for all patients.|Over 48 hours from infusion initiation||||percentage of measurements|||Number
1332450|NCT02058940|Secondary|Percentage of Patients Requiring Rescue Insulin Infusion Protocol|Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment|Over 48 hours from infusion initiation||||percentage of patients|||Number
1332451|NCT02058940|Secondary|Median Insulin Use|Calculated from number of insulin units administered over 48 hours starting at infusion initiation|Over 48 hours from infusion initiation||||units/kg||Inter-Quartile Range|Median
1332452|NCT02058940|Secondary|Glycemic Variability|Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||mg/dL||Inter-Quartile Range|Median
1332453|NCT02058940|Secondary|Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)|Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||minutes||Inter-Quartile Range|Median
1332454|NCT02058940|Secondary|Percentage of Glucose Measurements Within Goal Range|Percentage of glucose measurements within goal range is calculated as the number of glucose measurements within goal range (110-180 mg/dL) for all patients/total number of glucose measurements collected for all patients.|Over 48 hours from infusion initiation||||percentage of measurements|||Number
1332455|NCT02058940|Secondary|Median Glucose Concentration During Exenatide Infusion|Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||mg/dL||Inter-Quartile Range|Median
1332456|NCT02058940|Primary|Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria|Feasibility is defined as the percentage of patients 1) experiencing severe hypoglycemia (<40 mg/dL); 2) achieving glucose measurements within goal (110-180 mg/dL); and 3) experiencing nausea requiring discontinuation of exenatide therapy. The pre-specified criteria for determining feasibility includes the following: 1) at least 75% of patients achieving glucose measurements within goal (110-180 mg/dL) and 2) no more than 25% of patients experiencing severe hypoglycemia (<40 mg/dL) or nausea requiring exenatide discontinuation.|Over 48 hours from infusion initiation||||percentage of patients|||Number
1332457|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|6 months||||units of analgesics||Standard Deviation|Mean
1332458|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|3 months||||units of analgesics||Standard Deviation|Mean
1332459|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|1 month||||units of analgesics||Standard Deviation|Mean
1332460|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|1 week||||units of analgesics||Standard Deviation|Mean
1332461|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.|6 months||||units on a scale||Standard Deviation|Mean
1332462|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.|3 months||||units on a scale||Standard Deviation|Mean
1332558|NCT02058069|Secondary|Participants With Limb Alignment Difference <4.38 Degrees|The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure.|Pre-op Plan, 3 Month Post Op|Participants = knees|||Participants|||Count of Participants
1332463|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score. To assess the QOL, a SF-36 was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The score range is 0-100 and higher scores denotes better outcomes.|1 month||||units on a scale||Standard Deviation|Mean
1332464|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.|1 week||||units on a scale||Standard Deviation|Mean
1332465|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|6 months||||units on a scale||Standard Deviation|Mean
1332466|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|3 months||||units on a scale||Standard Deviation|Mean
1332467|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|1 month||||units on a scale||Standard Deviation|Mean
1332468|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain Score (VAS). It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|Baseline and 1 Week Post Injection||||units on a scale||Standard Deviation|Mean
1332469|NCT02058628|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication|Adverse events are defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse events are defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect and medically significant. TEAEs and TESAEs were reported up to 12 weeks.|Up to Week 12|ITT population.|||Participants|||Count of Participants
1332470|NCT02058628|Secondary|Absolute Change From Baseline in Total Score as Per Children’s Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12|This outcome measure was a measure of QOL. The CDLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0–3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The CDLQI was for participants with 12 to 16 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1332482|NCT02058589|Secondary|Number of Subjects With Changes in Allograft Function|Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented.|From 1 month post last vaccination (Month 2) until study end (Month 13)|The analysis was performed on subjects with pre and post vaccination serum creatinine data available from Month 2 to Month 13, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332471|NCT02058628|Secondary|Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12|This outcome measure was a measure of quality of life (QOL). The DLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0–3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The DLQI was for participants with 17 to 45 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1332472|NCT02058628|Secondary|Number of Treatment Adherent Participants at Week 12|The general assessment of ‘overall satisfaction’ with study therapy was assessed at week 12 on a 0-4 point rating scale (0-Very satisfied, 1- Satisfied, 2- Neutral, 3- Unsatisfied and 4- Very unsatisfied).|Week 12|MITT population.|||Participants|||Count of Participants
1332473|NCT02058628|Secondary|Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)|The product acceptability and preference questionnaire (PAP-Q ) served as a patient satisfaction score and was performed only once at the final study visit (ie, after 12 weeks (V5) or earlier in case of premature termination). Severity of each facial acne sign and symptom (scaling, redness, dryness, burning, itching) was based on a 0-5 point rating scale (0- None, 1- Very minimal, 2- Mild, 3- Moderate, 4- Severe, 5- Very severe).|Week 12|MITT population.|||Participants|||Count of Participants
1332474|NCT02058628|Secondary|Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12|Tolerability was assessed by the participants based on a 0–3 point rating scale for stinging/burning (S/B) and pruritus of the face (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the Baseline visit to post-baseline visits.|Baseline (Day 1), Weeks 2, 4, 8 and 12|MITT population.|||Participants|||Count of Participants
1332475|NCT02058628|Secondary|Number of Participants With Participant Global Change Assessment Score 12 Weeks|An SGCA was conducted by the participant to assess the efficacy of treatment on Week 2, 4, 8 and 12 as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse and missing.|Weeks 2, 4, 8 and 12|MITT population.|||Participants|||Count of Participants
1332476|NCT02058628|Secondary|Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12|Tolerability was assessed by investigator on a 0-3 point rating scale for erythema (0- None, 1- Slight, 2- Some and 3- Very red), dryness (0- None, 1- Slight, 2- Some and 3- Very dry) and peeling (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the baseline visit to post-baseline visits. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12|MITT population.|||Participants|||Count of Participants
1332477|NCT02058628|Secondary|Number of Participants With Change From Baseline in Investigator’s Static Global Assessment (ISGA) to Weeks 2,4,8 and 12|ISGA was conducted at all study visits. The area considered for the ISGA was confined to the face. A 0–5 point rating scale was used: 0 means Clear- Clear skin with no IL or NIL, 1 means Almost Clear- Rare NIL with no more than one small IL, 2 means Mild- Some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3 means Moderate- Up to many NIL and may have some IL, but no more than one small nodular lesion, 4 means Severe- Up to many NIL and IL, but no more than a few nodular lesions and 5 means Very Severe- Many NIL and IL and more than a few nodular lesions, may have cystic lesions.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population.|||Participants|||Count of Participants
1332478|NCT02058628|Secondary|Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count|The average time to 50 percent reduction of the calculated total lesion count was analyzed by determination of the number of days between Baseline and the first visit with a 50 percent reduction of the count.|Week 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Days||Full Range|Median
1332479|NCT02058628|Secondary|Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12|A count of IL (papules and pustules, including nasal lesions),NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.|Baseline (Day 1) up to Week 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1332480|NCT02058628|Secondary|Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12|A count of IL (papules and pustules, including nasal lesions), NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.|Baseline (Day 1) up to Week 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Lesions||Standard Deviation|Mean
1332481|NCT02058628|Primary|Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 – Superiority Analysis|A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values. Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores.|Baseline (Day 1) and Week 4|Modified intent-to-treat (MITT) population consisted of all participants in the ITT analysis set who had a baseline measurement of the number of IL and who had at least one post-baseline measurement of the number of IL.|||Percent change||Standard Deviation|Mean
1332483|NCT02058589|Secondary|Number of Subjects With Renal Allograft Rejection|Renal allograft rejection was confirmed through biopsy.|From 1 month post last vaccination (Month 2) until study end (Month 13).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332484|NCT02058589|Secondary|Number of Subjects With Any pIMDs|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From 1 month post last vaccination (Month 2) until study end (Month 13).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332485|NCT02058589|Secondary|Number of Subjects With Any and Related SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination.|From 1 month post last vaccination (Month 2) until study end (Month 13).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.If a subject reported a SAE exactly 1 month post-last vaccination (Month 2), it is possible that he/she might have also been taken into consideration for the Day0 up to Month2 SAEs assessment|||Participants|||Count of Participants
1332486|NCT02058589|Secondary|Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells|Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/10 million CD4+ T-cells); For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.|At Months 2 and 13|The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).|||Participants|||Count of Participants
1332487|NCT02058589|Secondary|Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells|Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS).|At Months 0, 2 and 13|The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
1332488|NCT02058589|Secondary|Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by ELISA.|At Months 1, 7 and 13|The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1332489|NCT02058589|Secondary|Anti-gE Antibody Concentrations|Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL.|At Months 0, 1, 2, 7 and 13|The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1332490|NCT02058589|Primary|Number of Subjects With Changes in Allograft Function|Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented.|From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on subjects with pre and post vaccination serum creatinine data available up to Month 2, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332491|NCT02058589|Primary|Number of Subjects With Renal Allograft Rejection|Renal allograft rejection was confirmed through biopsy.|From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332492|NCT02058589|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination.|From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332493|NCT02058589|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332516|NCT02058537|Other Pre-specified|Change From Baseline Composite Vital Signs to Day 7|Vital signs include temperature, heart rate, breathing rate, and blood pressure. This variables will be measured during the study in order to assess any negative systemic effects of the study drug. These measurements are assessed as a composite and not individually therefore are grouped together as one outcome measure.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.||||||
1332494|NCT02058589|Primary|Number of Subjects With Unsolicited Symptoms (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332495|NCT02058589|Primary|Days With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].|Within 7 days (Days 0-6) after each dose and overall/dose|The analysis was performed on the subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Days||Inter-Quartile Range|Median
1332496|NCT02058589|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain.|Within 7 days (Days 0-6) after each dose and across doses|The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332497|NCT02058589|Primary|Days With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling.|Within 7 days (Days 0-6) after each dose and overall/dose|The analysis was performed on the subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Days||Inter-Quartile Range|Median
1332498|NCT02058589|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Pain when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Days 0-6) after each dose and across doses.|The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
1332499|NCT02058589|Primary|Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter [mIU/ml]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).|At Month 2.|The analysis was performed on the According-to-Protocol (ATP) cohort for humoral immunogenicity, which included all evaluable subjects up to Month 2, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1332500|NCT02058563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1332501|NCT02058563|Secondary|Number of Subjects Reporting Adverse Events Prompting ER Visits|Occurrence of AEs prompting emergency room (ER) visits.|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1332502|NCT02058563|Secondary|Number of Subjects Reporting NOCDs|Occurrence of new onset chronic diseases (NOCDs)|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1332503|NCT02058563|Secondary|Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)|Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||subjects|||Number
1332504|NCT02058563|Secondary|Number of Subjects Reporting Solicited Rash Symptom|Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
1332505|NCT02058563|Secondary|Number of Subjects Reporting Unsolicited AEs|Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1332976|NCT02046382|Primary|Total Oxycodone (mg)|Total oxycodone (mg) for breakthrough pain during inpatient stay|approximately 2 - 7 days||||mg||Standard Deviation|Mean
1332506|NCT02058563|Secondary|Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.|Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
1332507|NCT02058563|Secondary|Number of Subjects Reporting Fever|Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever >39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
1332508|NCT02058563|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter >50mm. Grade 3 swelling = swelling with surface diameter >50mm.|During the 4-day (Days 0-3) post-vaccination period|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
1332509|NCT02058563|Secondary|Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.|For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
1332510|NCT02058563|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).|"Seroresponse was defined as:~Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
1332511|NCT02058563|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).|"Seroresponse was defined as:~Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
1332512|NCT02058563|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)|"Seroresponse was defined as:~Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
1332513|NCT02058563|Primary|Anti-rubella Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
1332514|NCT02058563|Primary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||EU/mL||95% Confidence Interval|Geometric Mean
1332515|NCT02058563|Primary|Anti-measles Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
1332517|NCT02058537|Secondary|Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7|This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.||||||
1332518|NCT02058537|Primary|Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7|The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.||||||
1332519|NCT02058498|Secondary|Number of Patients Who Document Their Physical Activity|8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.|Baseline to 6 weeks, repeated measure at 4 months||||participants|||Number
1332520|NCT02058498|Secondary|Quality of Life at Baseline, 6 Weeks, and 4 Months|Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.|Baseline, 6 weeks, 4 months||||units on a scale||Standard Deviation|Mean
1332521|NCT02058498|Primary|Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)|The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).|Baseline, 6 weeks||||MET||Full Range|Median
1332522|NCT02058290|Secondary|Patient Satisfaction With Pain Treatment After Surgery|Responses to question pertaining to patient satisfaction with pain treatment|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||participants|||Number
1332523|NCT02058290|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||participants|||Number
1332524|NCT02058290|Primary|Health Economic Benefits - Length of Stay (LOS)|Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||days||Full Range|Median
1332525|NCT02058290|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||dollars||Standard Deviation|Mean
1332526|NCT02058290|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||mg||Standard Deviation|Mean
1332527|NCT02058160|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.|||percentage of participants|||Number
1332528|NCT02058160|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.|||percentage of participants|||Number
1332529|NCT02058160|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.|||events per subject-year|||Number
1332530|NCT02058160|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.|||percentage of participants|||Number
1332531|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.|||percentage of participants|||Number
1332532|NCT02058160|Secondary|Change in 2-hour PPG From Baseline to Week 30|Change in PPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline PPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
1332533|NCT02058160|Secondary|Change in FPG From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline FPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
1332534|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
1332535|NCT02058160|Secondary|Change in Daily Insulin Glargine Dose From Baseline to Week 30||Baseline, Week 30|mITT population. The analysis included scheduled measurements obtained up to the date of last injection of IMP. Here, number of participants analyzed= participants with insulin glargine dose assessment during study period.|||Units (U)||Standard Error|Least Squares Mean
1332536|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
1332537|NCT02058160|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline 7-point SMPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
1332538|NCT02058160|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.|||kg||Standard Error|Least Squares Mean
1332539|NCT02058160|Secondary|Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period. Missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
1332540|NCT02058160|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30||Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.|||percentage of participants|||Number
1332541|NCT02058160|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.|||percentage of HbA1c||Standard Error|Least Squares Mean
1332542|NCT02058147|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not have been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk of injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.|||percentage of participants|||Number
1332543|NCT02058147|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.|||percentage of participants|||Number
1332544|NCT02058147|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.|||Events per subject-year|||Number
1333201|NCT02045238|Primary|Rate of Admission|Patients staying longer than 24h are considered to be admitted to ward.|24 hours|Number of participants analyzed was too small to obtain statistic significance|||participants|||Number
1332545|NCT02058147|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) was performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.|||percentage of participants|||Number
1332546|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication.|Baseline up to Week 30|mITT population. Participants without Week 30 value for HbA1c were counted as non-responders.|||percentage of participants|||Number
1332547|NCT02058147|Secondary|Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 2-hour PPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
1332548|NCT02058147|Secondary|Average Daily Insulin Glargine Dose at Week 30|The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy.|Week 30|mITT population. Here, number of participants analyzed = participants with insulin glargine dose assessment during study period. Data of this endpoint was planned to be analyzed for Insulin Glargine/Lixisenatide FRC and Insulin glargine arms only, not for lixisenatide arm.|||Units (U)||Standard Error|Least Squares Mean
1332549|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
1332550|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
1332551|NCT02058147|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.|Baseline, Week 30|mITT population. Here,number of participants analyzed = participants with baseline and at least one post baseline 7-point SMPG assessment during study period.|||mmol/L||Standard Deviation|Least Squares Mean
1332552|NCT02058147|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analysed = participants with baseline and at least one post-baseline FPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
1332553|NCT02058147|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.|||kg||Standard Error|Least Squares Mean
1332554|NCT02058147|Secondary|Change in Plasma Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF).|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
1332555|NCT02058147|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30|Participants without Week 30 value for HbA1c were counted as non-responders.|Week 30|mITT population.|||percentage of participants|||Number
1332556|NCT02058147|Primary|Change in HbA1c From Baseline to Week 30|"Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine.~Change in HbA1c was calculated by subtracting baseline value from Week 30 value."|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1332557|NCT02058069|Other Pre-specified|Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)|"The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes.~The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment."|Pre-Op, 3 Month Post Op [change assessed between the two time periods]|participants = knees.|||units on a scale||Standard Deviation|Mean
1332559|NCT02058069|Secondary|Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative|Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.|pre-op plan, 3 Month Post Op|Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes).|||degrees||Standard Deviation|Mean
1332560|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|3 Month Post Op|participants = knees.|||intra-operative complications|||Number
1332561|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.|participants = knees.|||intra-operative complications|||Number
1332562|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.|participants = knees.|||intra-operative complications|||Number
1332563|NCT02057952|Secondary|Change in Diastolic Blood Pressure Baseline to 12 Months|Diastolic blood pressure change from baseline to 12 months. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months; negative value indicates decrease in blood pressure).|12 Months|Participants who completed 12 month follow-up|||mmHg||Standard Deviation|Mean
1332564|NCT02057952|Secondary|Change in Diastolic Blood Pressure at 6 Months|Change in pressure from baseline to 6 months|6 Months||||mmHg||Standard Deviation|Mean
1332565|NCT02057952|Secondary|Change in Systolic Blood Pressure|Change in pressure from baseline to 6 months|6 Months||||mmHg||Standard Deviation|Mean
1332566|NCT02057952|Secondary|Change in SF 36 From Baseline to 6 Months|The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.|6 Months||||units on a scale||Standard Deviation|Mean
1332567|NCT02057952|Secondary|Cost-effectiveness|The cost effectiveness ratios were calculated by dividing the difference in total cost per arm by the difference in percent of subjects with 2+ kg weight loss|12 months||||Total Cost / 100 participants|||Number
1332568|NCT02057952|Secondary|Change in Systolic Blood Pressure|Systolic blood pressure. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months). Negative value indicates decrease in blood pressure.|12 Months|Participants who completed 12 month follow-up|||mmHg||Standard Deviation|Mean
1332569|NCT02057952|Secondary|Change in Short Form 36 Survey Score|The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.|Baseline to 12 Months|The analysis of change based on participants with complete Short Form 36 (SF36) scores at baseline and 12 months.|||score on scale||Standard Deviation|Mean
1332570|NCT02057952|Primary|Change in Body Weight From Baseline to 6 Months.|Change in body weight from baseline to 6 months.|12 months|Analysis are based on number of participants with complete weight data at baseline and 6 months.|||pounds||Standard Deviation|Mean
1332571|NCT02057952|Primary|Attendance Reported in Minutes|Minutes of participation in study sessions.|12 Months|Usual care participants didn't have access to the experimental treatments. In person and video conference arm participants were all eligible for participation.|||minutes||Full Range|Median
1332572|NCT02057952|Primary|Body Weight|Change in weight from baseline to 12 months reported in pounds.|Baseline to 12 Months|The number of participants analyzed is based on the number of participants who completed weight data at baseline and 12 months.|||pounds||Standard Deviation|Mean
1332573|NCT02057874|Secondary|Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Overall Survival (OS)|Proportional hazard model will be employed to assess the ability of the longitudinal change (relative to pretreatment baseline) in each of the 3T MR imaging metrics (Ktrans, ADC, MTR, and APTasym) to predict patient survival outcomes, time-to-progression (TTP) and progression-free survival (PFS) as well as overall survival (OS). The calibration of prediction will be validated by computing the difference between predicted survival and Kaplan-Meier survival estimates at a fixed time, which estimates the over-optimism of the difference using bootstrapping.|Baseline to up to 6 months post-TACE|Due to loss of funding data were not collected||||||
1332574|NCT02057874|Secondary|Correlation of Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Pathological Response Within Explanted Tissue Following Orthotopic Liver Transplant (OLT)|Histopathological features on explanted livers following OLT, including percentage necrosis and cellular density as determined by hematoxylin and eosin staining, as well as the extent of fibrosis as determined by collagen staining, will be assessed for correspondence with findings on ex vivo 3T MRI.|Subset of patients undergoing OLT: within 12 hours following surgery|Due to loss of funding data were not collected||||||
1332575|NCT02057874|Secondary|Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Changes in the Ratio of Viable-to-necrotic Tumor Volume|Longitudinal changes in 3T MRI-derived measures and the change in the ratio of viable vs. necrotic tumor will be assessed by using a GLM approach in which the underlying temporal correlation can be modeled via an autoregressive order one (AR(1)) structure, validated by computing Akaike Information Criterion (AIC) against the other common structures, e.g., unstructured and constant correlation.|Baseline to up to 12 weeks post-TACE|Due to loss of funding data were not collected||||||
1332576|NCT02057874|Secondary|Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Time-to-progression (TTP).|Proportional hazard model will be employed to assess the ability of the longitudinal change (relative to pretreatment baseline) in each of the 3T MR imaging metrics (Ktrans, ADC, MTR, and APTasym) to predict patient survival outcomes, time-to-progression (TTP) and progression-free survival (PFS) as well as overall survival (OS). The calibration of prediction will be validated by computing the difference between predicted survival and Kaplan-Meier survival estimates at a fixed time, which estimates the over-optimism of the difference using bootstrapping.|Baseline to up to 6 months post-TACE|Due to loss of funding data were not collected||||||
1332577|NCT02057874|Primary|Correlation of Changes in Imaging Biomarkers (Ktrans, ADC, MTR, and APTasym) as Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively, With Changes in Tumor Volume (mRECIST).|The following will be longitudinally measured using 3 Tesla (3T) magnetic resonance imaging (MRI) prior to transarterial chemoembolization (TACE) and 2-4, 4-8, and 12 weeks following TACE: 1) the volume transfer coefficient (Ktrans), measured by dynamic contrast-enhanced (DCE) MRI; 2) the apparent diffusion coefficient (ADC), measured by diffusion-weighted (DW) MRI; 3) the magnetization transfer ratio (MTR), measured by magnetization transfer (MT) MRI; and 4) the amide proton transfer asymmetry (APTasym), measured by chemical exchange saturation transfer (CEST) MRI. We will use a general linear model (GLM) approach to measure the association between changes in each of the above imaging metrics (relative to pretreatment baseline) and changes in tumor volume (according to standard-of-care modified RECIST) at 3 or 6 month follow-up, accounting for the effect of potential confounders, e.g., age and size of the tumor at baseline.|Baseline to up to 12 weeks post-TACE|Due to loss of funding data were not collected||||||
1332578|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2) - Overall|Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
1332579|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2)|Terminal half-life (T1/2) of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
1332580|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1332581|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1332582|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1332583|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1332584|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Full Range|Median
1332604|NCT02057757|Secondary|Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28)|Number of study participants (e.g., adult and children) admitted to the intensive care unit (ICU) by time point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.|Measured through Day 28 or participants' last day in the ICU||||Participants|||Count of Participants
1332585|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax)|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Full Range|Median
1332586|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax) - Overall|Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1332587|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax)|Maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1332588|NCT02057835|Primary|Percentage of Participants With Drug Related Adverse Events|Percentage of participants with drug related adverse events (AEs)|From drug administration until 31 days after drug administration, 31 days|Treated set|||Percentage of participants|||Number
1332589|NCT02057757|Secondary|Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28|Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||10^3 cells/mcL||Standard Deviation|Mean
1332590|NCT02057757|Secondary|Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28|Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||g/dL||Standard Deviation|Mean
1332591|NCT02057757|Secondary|Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28|Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||percentage of blood||Standard Deviation|Mean
1332592|NCT02057757|Secondary|Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28|Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||mg/L||Standard Deviation|Mean
1332593|NCT02057757|Secondary|Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28|Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.|Measured on Day 3, Day 7, and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||U/L||Standard Deviation|Mean
1332594|NCT02057757|Secondary|Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28|Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||mg/dL||Standard Deviation|Mean
1332595|NCT02057757|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs)|Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).|Measured through Day 28 or participants' last day of hospitalization|The analysis is based on the safety population.|||Participants|||Count of Participants
1332596|NCT02057757|Secondary|Number of Participants Reporting Adverse Events (AEs)|Number of study participants with at least one Adverse Event During Study Duration|Measured through Day 28 or participants' last day of hospitalization|Analysis was based on the safety population.|||Participants|||Count of Participants
1332597|NCT02057757|Secondary|Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)|Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.|Measured through Day 3|Efficacy analysis of Intent to Treat population|||Participants|||Count of Participants
1332598|NCT02057757|Secondary|Use of Systemic Corticosteroids|Number of study participants taking Systemic Steroids during first 5 days.|Measured within First 5 Days|The analysis was based on the Intent to Treat (ITT) population.|||Participants|||Count of Participants
1332599|NCT02057757|Secondary|Number of Participants Who Are Re-hospitalized Within 28 Days|Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).|Measured through Day 28|The Adult (>=18 Years) population includes 126 participants (63 in NTZ arm; 63 in Placebo arm). The Children (<18 Years) population includes 131 participants (67 in NTZ arm; 64 in Placebo arm)|||participants|||Number
1332600|NCT02057757|Secondary|Number of Participants Using Antibiotics/Antivirals During Hospitalization|Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.|Measured through participants' first 5 days of hospitalization||||Participants|||Count of Participants
1332601|NCT02057757|Secondary|Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)|Study participant (e.g., adults and children) answers (e.g., yes) to global assessment questions measured daily through Day 14 and then again on Day 28.|Measured daily through Day 14 and on Day 28||||days||Standard Error|Mean
1332602|NCT02057757|Secondary|Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study|Number of study participants (e.g., adults and children) with the presence of a complication (pneumonia, respiratory failure requiring mechanical ventilation, acute respiratory distress syndrome [ARDS], sepsis, or bronchiolitis) during the study .|Measured through Day 28 or participants' last day of hospitalization||||Participants|||Count of Participants
1332603|NCT02057757|Secondary|Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28)|Study participants (e.g., adults, children) requiring mechanical ventilation (e.g., intubation/extubation) at study time points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.|Measured through Day 28 or participants' last day of hospitalization||||Participants|||Count of Participants
1332605|NCT02057757|Secondary|Number of Participants Who Require Oxygen Use|Number of study participants who require use of supplemental oxygen at time points (e.g., Any time, Day 0, Day 3, Day 7, Day 14, and Day 28)|Measured through Day 28 or participants' last day of hospitalization||||Participants|||Count of Participants
1332606|NCT02057757|Secondary|Duration of Fever in Study Participants|Study participants' duration (hours) of fever measured daily through Day 14 and then again on Day 28. The total duration in hours from the visit when fever was registered for the study participant until the next visit when no fever was registered for the study participant.|Measured each day through Day 14 and on Day 28||||hours||Standard Error|Mean
1332607|NCT02057757|Secondary|Number of Participants Who Experienced Clinical Symptoms|Measured daily through Study Day 14 and then again on Study Day 28|Measured through Day 28||||Participants|||Count of Participants
1332608|NCT02057757|Secondary|Number of Participants Who Died Within the First 5 Days|Total Deaths of Participants, including Deaths within First 5 Days|Measured within First 5 Days|The Adult (>=18 Years) population includes 126 participants (63 in NTZ arm; 63 in Placebo arm). The Children (<18 Years) population includes 131 participants (67 in NTZ arm; 64 in Placebo arm)|||participants|||Number
1332609|NCT02057757|Secondary|Number of Participants Hospitalized on Days 3, 7, 14, and 28|The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.|Measured at Day 3, Day 7, Day 14, and Day 28|Number of study participants - adults (>= 18 years) and children (< 18 years) in the Intent-to-Treat population (ITT) hospitalized by time point|||participants|||Number
1332610|NCT02057757|Primary|Time to Hospital Discharge|The time to hospital discharge measured through Day 28.|Measured through Day 28||||Days||Standard Error|Mean
1332611|NCT02057692|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An AE was any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.TEAEs were defined as AEs/SAEs that started or worsened after the study drug treatment.|Baseline up to Week 17 (follow up)|The Safety Population included all participants who were randomly assigned to study treatment and received at least one dose of the study drug.|||Participants|||Count of Participants
1332612|NCT02057692|Secondary|Change From Baseline to Endpoint (Week 13/Early Termination) in Total and Direct Bilirubin Concentrations|Liver enzyme levels of total bilirubin and direct bilirubin were reported here.|Baseline, Week 13/Early Termination|mITT population included all participants randomly assigned to study treatment, receiving at least 1 dose of treatment, and having at least 1 post baseline observer itch reported outcome (ItchRO[Obs]) average daily score.|||Milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
1332613|NCT02057692|Secondary|Change From Baseline to Endpoint (Week 13/Early Termination) in Liver Enzyme Levels|Liver enzyme levels of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase and gamma glutamyl transferase were reported here.|Baseline, Week 13/Early Termination|mITT population included all participants randomly assigned to study treatment, receiving at least 1 dose of treatment, and having at least 1 post baseline observer itch reported outcome (ItchRO[Obs]) average daily score.|||Unit per liter (U/L)||Standard Error|Least Squares Mean
1332614|NCT02057692|Secondary|Change From Baseline to Endpoint (Week 13/Early Termination) in Fasting Serum Bile Acid (sBA) Level|Fasting sBA level was measured by using a liquid chromatography mass spectrometry method. Total serum bile acid concentrations were calculated as sum of individual bile acid concentration.|Baseline, Week 13/Early Termination||2018-11-30|11/2018||||
1332615|NCT02057692|Primary|Change From Baseline to Endpoint (Week 13/Early Termination) in Pruritus|Pruritus was assessed using Itch report outcome measure (ItchRO[Obs]) measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). ItchRO(Obs) score ranged from 0 to 4, with the higher score indicating increasing itch severity. The highest score between the morning and evening ItchRO(Obs) reports represented the daily score: a measure of the worst itching over the previous 24-hour period.|Baseline, Week 13/Early Termination|Modified Intent-to-Treat Population (mITT) population included all participants randomly assigned to study treatment, receiving at least 1 dose of treatment, and having at least 1 post baseline observer itch reported outcome (ItchRO[Obs]) average daily score.|||Unit on a scale||Standard Error|Least Squares Mean
1332616|NCT02057549|Secondary|Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication||1 hour after study medication given||||Participants|||Count of Participants
1332617|NCT02057549|Secondary|Nausea Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.|1 hour after study medication given||||units on a scale||Standard Deviation|Mean
1332618|NCT02057549|Secondary|Nausea Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.|before study medication given||||units on a scale||Standard Deviation|Mean
1332619|NCT02057549|Secondary|Pain Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.|1 hour after study medication given||||units on a scale||Standard Deviation|Mean
1332620|NCT02057549|Secondary|Pain Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.|before study medication given||||units on a scale||Standard Deviation|Mean
1332621|NCT02057549|Secondary|Emergency Department Length of Stay (EDLOS)|"The time frame starts from the moment of receiving the study drug to the time when the decision for final disposition is made. Usually after symptoms are controlled, patients are given a PO challenge (food or drink) in order to establish if they are OK to go home. If symptoms return, additional medications are given, the treatment is consider failed and they are admitted to the Hospital.~Patients will not be followed up if admitted to any service. The study ends when final disposition is made.~Patients follow up after final disposition is not part of the study and will not be done."|at the time the decision for final disposition is made (about 8 hours)||||hours||Inter-Quartile Range|Median
1332624|NCT02057406|Primary|Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values.|Endpoint EPA values are mean values adjusted for age, race, sex, treatment site, and the baseline EPA value. Red blood cell/plasma EPA values are expressed as a percent of total identified fatty acids.|Week 12|"The numbers at baseline reflect the total number of patients who provided samples for the assay of omega 3 percentage of total fatty acids.~The numbers at endpoint reflect the total number of patients included in the intention to treat analysis."|||percentage of total fatty acids||Standard Error|Mean
1332625|NCT02057406|Primary|Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores.|Endpoint HAMD scores are mean values adjusted for age, race, sex, treatment site, and the baseline HAMD value. The range for the HAMD scores is 0 to 52 with higher scores indicating a greater severity of depressive symptoms.|Week 12||||units on a scale||Standard Error|Mean
1332626|NCT02057393|Primary|Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes|The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.|2 weeks||||number of sentinel nodes per patient||Standard Deviation|Mean
1332627|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 12 weeks after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.||||||
1332628|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 7 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.||||||
1332629|NCT02057276|Primary|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 3 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.||||||
1332630|NCT02057250|Secondary|Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab|AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).|Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85|Pharmacokinetic(PK) population included all randomized participants who received at least 1 dose of IMP and have least 1 PK parameter calculated using non compartmental methods following the first (Day 1) or sixth administration (Day 71). Here, Number Analyzed = participants with available data for specified category for each arm, respectively.|||mg*day/L||Standard Deviation|Mean
1332631|NCT02057250|Primary|Number of Validated AID Associated Product Technical Failures (PTFs)|A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was “no” to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.|Baseline up to Week 12|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of investigational medicinal product (IMP) with AID and attended at least 1 post-baseline visit during AID assessment phase of the study.|||PTFs|Injections||Number
1332632|NCT02057237|Secondary|Prostate Specific Antigen (PSA) Response Rate|"Continue increase of serum PSA beyond 8 weeks indicate PSA progression. Response and progression will be primarily evaluated in this study using PSA response criteria from the Prostate Cancer Working Group 2. Criteria used to define response include: at least a 50% decline in PSA, confirmed by a second measurement ≥4 weeks later. PSA progression is defined by a >25% increase from baseline in patients whose PSA did not decrease, and of 50% from the nadir value in patients whose PSA decreased. This increase in PSA must be >5 ng/ml, and confirmed by a second measurement, at least 1 week later; PSA nadir is defined as the minimum PSA value that was confirmed by a second measurement.~PSA progression free survival is defined as the time between the randomization date and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first."|PSA progression free survival and excessive toxicity. Plan to keep the patients on Mitotane for atleast 8 weeks, despite increasing level of PSA as other trials shown early increase in PSA followed by a subsequent decline.|||||||
1332633|NCT02057237|Primary|The Primary Endpoint is the Proportion of Patients Maintained on Mitotane After 12 Consecutive Weeks of Therapy. A Positive Outcome Would be Seeing 50% or More Patients Maintained on Therapy. Secondary Endpoint Include Proportion of Adverse Events||maintain 50% of the patients on Mitotane at the 12 week mark|As only 1 patient was accrued to this trial, no data analysis was performed.||||||
1332634|NCT02057068|Secondary|BEF-SHI Total Number of Negative Sleep Hygiene Behaviors|Total Number of negative sleep hygiene indicators from the BEFSHI - Bedtime Environmental Features and Sleep Hygiene Index (e.g., nighttime caffeine, nighttime snacking-sugar, nicotine, excessive alcohol, excessive daytime napping, television, tablet and computer use in bedroom after 9 pm etc.) Participants are asked to respond yes (1) or no (0) to a series of sleep hygiene behaviors considered detrimental to sleep. Scores are summed. Possible scores range from 0-8 with a greater score indicating a greater number of negative sleep hygiene behaviors endorsed.|Baseline (T1) and Post-Intervention (T2) - 8 Weeks||||units on a scale||Standard Deviation|Mean
1332635|NCT02057068|Secondary|Mean Sleep Efficiency|Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep.|Baseline (T1) and Post-Intervention (T2) - 8 Weeks||||percentage of sleep/time in bed||Standard Deviation|Mean
1332636|NCT02057068|Primary|Subjective Sleep Quality|Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score > 5 (some evidence for 8) is indicative of poor sleep quality.|Baseline (T1) and Post-Intervention (T2) - 8 Weeks||||units on a scale||Standard Deviation|Mean
1332637|NCT02056834|Primary|Mean Time to Union|Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function|12 months||||months||Standard Deviation|Mean
1332638|NCT02056834|Secondary|Lysholm Knee Scale|The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The survey was administered to subject at follow-up visits and comprises 8 subscales related to limp, support, stair climbing, squatting, walking, running and jumping as well as a question related to the atrophy of the thigh. The responses to these 8 questions are graded to provide a maximum result of 100 points.|12 months||||participants|||Number
1332639|NCT02056834|Secondary|VAS Leg Pain Frequency|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain frequency was rated on a 100-mm visual analog scale where zero indicated no pain at all and 100 represented pain always.|12 months||||units on a scale||Standard Deviation|Mean
1332640|NCT02056834|Secondary|VAS Leg Pain Intensity|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain intensity was rated on a 100-mm visual analog scale where zero indicated no pain at all, and 100 represented the worst possible pain.|12 months||||units on a scale||Standard Deviation|Mean
1332641|NCT02056834|Secondary|SF-12 Short Form Health Survey Mental Composite Score (MCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and at follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months||||units on a scale||Standard Deviation|Mean
1332642|NCT02056834|Secondary|SF-12 Short Form Health Survey Physical Composite Score (PCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and all follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months||||units on a scale||Standard Deviation|Mean
1332643|NCT02056834|Secondary|Peri-operative Complications||12 months||||participants|||Number
1332644|NCT02056834|Secondary|Extension Ability and Stability|"The following was assessed:~extension ability of the knee~stability of the knee in extension"|12 months||||participants|||Number
1332645|NCT02056834|Secondary|Surgeon’s Satisfaction With the Product|Satisfaction with product was assessed by the surgeon post-operatively, where surgeons indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated absolutely unacceptable, while a score of 100 indicated very satisfying.|Post-surgery||||units on a scale||Standard Deviation|Mean
1332646|NCT02056834|Secondary|Patient’s Satisfaction|Satisfaction with treatment was assessed by the subjects, where subjects indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|12 months||||units on a scale||Standard Deviation|Mean
1332647|NCT02056834|Secondary|Anatomical Gradings Assessed Radiographically|"The following was assessed:~depression of knee joint: presence or absence~condylar widening (enlargement of the knee joint): presence or absence~angulation; valgus/varus (abnormal outward/inward turning of the knee): presence or absence"|12 months||||participants|||Number
1332648|NCT02056834|Secondary|Total Range of Motion||12 months||||participants|||Number
1332649|NCT02056834|Secondary|Patients Who Reached Full Weight Bearing||12 months||||participants|||Number
1332650|NCT02056834|Secondary|Absorption Rate of Calcium Phosphate Cement|Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.|12 months||||percentage of absorption at 12 months||Standard Deviation|Mean
1332651|NCT02056834|Primary|Articular Subsidence|Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators|12 months||||participants|||Number
1332652|NCT02056834|Primary|Fracture Union|Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays|12 months||||participants|||Number
1332653|NCT02056652|Secondary|Number of Subjects Experiencing Chorioamnionitis|The AE of Chorioamnionitis was captured for each group.|Time of delivery||||Participants|||Count of Participants
1332654|NCT02056652|Secondary|Number of Subjects Experiencing Neonatal Death|Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group.|Between birth and 28 days of age||||Participants|||Count of Participants
1332655|NCT02056652|Secondary|Number of Participants Experiencing Spontaneous Rupture of Membranes|Rupture of membranes before 34 weeks gestation was captured in each group.|Less than 34 weeks gestation||||Participants|||Count of Participants
1332656|NCT02056652|Secondary|Number of Participants That Experienced Spontaneous Preterm Births on Trial|The number of spontaneous births that occurred in participants on trial before 37 weeks was captured.|Before 37 weeks gestation||||Participants|||Count of Participants
1332657|NCT02056652|Secondary|Average Birth Weight of Babies Born on Trial|The birth weights of babies born in the pessary group was compared to those born in the no pessary group|Time of delivery||||grams||Full Range|Mean
1332658|NCT02056652|Primary|Number of Subjects Experiencing Preterm Birth|Birth before 37 weeks gestation was captured.|Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)||||Participants|||Count of Participants
1332664|NCT02056431|Secondary|Number of Participants With Minimally Effective Dose in 12 Months|Count of patients who ever received a minimally effective dose of the medications they started on during the 12 months following treatment start (measured post only).|12 months|1179 Patient completed the close out survey|||Participants|||Count of Participants
1332665|NCT02056431|Primary|Change in Patient Quality of Life at Baseline and 8 Months|"The primary outcome measure is change in quality of life from baseline at eight months following study entry. We calculated the EuroQOL (EQ-5D) from the Global Health Scale, a 10-item Patient-Reported Outcomes Measurement Information System measure developed and validated in patients with neuropathy as part of the Quality of Life in Neurological Disorders Measures. The range for EQ-5D is 0-1, with 0 being the worst and 1 being the best."|Baseline and 8 months|1179 patients completed the close out survey|||units on a scale||Standard Deviation|Mean
1332666|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 24 hours (msec)|24 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332667|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 12 hours (msec)|12 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332668|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 8 hours (msec)|8 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332669|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 6 hours (msec)|6 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332670|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 4 hours (msec)|4 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332671|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 3 hours (msec)|3 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332672|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 2 hours (msec)|2 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332673|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour 30 min (msec)|1 hour 30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332674|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour (msec)|1 hour|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332675|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 30 minutes (msec)|30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
1332676|NCT02056171|Other Pre-specified|Change in Delirium Severity|Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores.|Baseline and 3 days of study drug initiation|Change in CAPD score from baseline to day 3. A decrease in total score implies an improvement in delirium. An increase in total score implies worsening delirium.|||units on a scale||Full Range|Median
1332677|NCT02056171|Secondary|Total ICU Days With Delirium|Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.|Within 10 days after study enrollment||||days||Full Range|Mean
1332678|NCT02056171|Primary|Time to First Resolution of Delirium|Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium [CAPD]). If delirium did not resolve within the 10 day period, this defaults to 10 days.|Within the first 10 days after study enrollment|All participants are included in analysis.|||days||Full Range|Mean
1332679|NCT02055430|Other Pre-specified|Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)|"age, site of stones, size of stones, degree of hydronephrosis~they were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week|||||||
1332680|NCT02055430|Secondary|The Number of Subsequent Interventions Needed for Clearance of Stones .|The number of subsequent interventions needed for clearance of stones after normalization of serum creatinine in relation to initial urinary drainage method using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure|6 months|||||||
1332681|NCT02055430|Primary|Complications of Each Drainage Method|"complications of initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure (mucosal complications, failure of insertion, slippage, fever and infection, hematuria, leakage)~complications were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week|||||||
1332682|NCT02055430|Primary|Period to Return to Normal Creatinine|"period required for normalization of serum creatinine after initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with obstructive calcular anuria and Acute Renal Failure~serum creatinine was compared to normal values in matched healthy children"|1 week||||days||Standard Deviation|Mean
1332683|NCT02055404|Primary|Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)|"Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: N/A; Not visible; Slightly visible, not acceptable; Slightly visible, acceptable; Clearly visible; More visible than necessary. Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. Visibility of Rotation Mark is reported as the percentage of assessments rating the rotation mark as Clearly visible or Slightly visible, acceptable."|Day 1|The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.|||Percentage of assessments|||Number
1332684|NCT02055365|Primary|Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).|Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.|Day 1, Day 3, Week 1, and Week 2|All participants received the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). RNA-Seq data from whole blood (PAXgene) for 9 participants were analyzed for differential gene expression at day 1, day 3, week 1, and week 2 after administration of the Hepatitis B Vaccine (Recombinant) (dose #1).|||number of genes at FDR<0.05|||Number
1332685|NCT02055365|Primary|Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).|Number of differentially expressed genes at time point versus prevaccination baseline (p<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.|Day 1, Day 3, Week 1, and Week 2|All participants received the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). RNA-Seq (RNA sequencing) data from whole blood (PAXgene) for 9 participants were analyzed for differential gene expression at day 1, day 3, week 1, and week 2 after administration of the Hepatitis B Vaccine (Recombinant) (dose #1).|||number of genes at p<0.05|||Number
1332686|NCT02055352|Secondary|Change in Health Status - SGRQ-C|St George’s Respiratory Questionnaire short version questionnaire will be completed by participants. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline, week 12 and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Score on a scale||Standard Error|Least Squares Mean
1332687|NCT02055352|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|Baseline and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Liters||Standard Error|Least Squares Mean
1332688|NCT02055352|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.|24 weeks|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients that were not discontinued before Visit 3 (day 28±3).|||Puffs||Standard Deviation|Mean
1332689|NCT02055352|Secondary|Change in Health Status - mMRC|Modified Medical Research Council scale (mMRC) questionnaire will be completed by participants. 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing|Baseline, week 12 and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Score on a scale||Standard Error|Least Squares Mean
1332690|NCT02055352|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Baseline and week 12|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Liters||Standard Error|Least Squares Mean
1332691|NCT02054910|Secondary|% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.|Subjects will be asked about employment at 6 months post procedure|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
1332692|NCT02054910|Secondary|Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure|The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group|baseline to 6 months|All subjects were lost to follow up by 6 months; since everyone dropped out at different times before the 6 month point, the data would not be evaluable.||||||
1332693|NCT02054910|Secondary|Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.|"The Beck's Depression scale was used to indicate subject's depression:~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression."|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
1332694|NCT02054910|Secondary|Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline|the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
1332695|NCT02054910|Secondary|Mean Quality of Life Score Between Each Group at 6 Months|The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).|6 months post baseline|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
1332696|NCT02054910|Primary|Change in Pain Response Over a 6 Month Period of Time Using the VAS Score|Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.|baseline to 6 months|All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject||||||
1332697|NCT02054897|Secondary|Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target|Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|At 30 weeks of treatment|Full analysis set|||Percentage of subjects|||Number
1332698|NCT02054897|Secondary|Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target|Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|At 30 weeks of treatment|Full analysis set|||Percentage of subjects|||Number
1332699|NCT02054897|Secondary|Change in Systolic and Diastolic Blood Pressure|Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set|||mmHg||Standard Deviation|Mean
1332700|NCT02054897|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set. Number of subject analysed=subjects who contributed to the analysis.|||mmol/L||Standard Deviation|Mean
1332701|NCT02054897|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set|||kilogram(s)||Standard Deviation|Mean
1332702|NCT02054897|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set|||Percentage of HbA1c||Standard Deviation|Mean
1332703|NCT02054754|Other Pre-specified|Pharmacodynamic Biomarker Assessment|Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.|Pre-dose, 1, 6 and 24 hours post dose|||||||
1332704|NCT02054754|Secondary|Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose|Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.|Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose||||ng.h/mL||Standard Deviation|Mean
1332705|NCT02054754|Primary|Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters|"Safety and tolerability based on the number of participants with adverse events. Assessment and comparison to baseline of the following:~Physical exam~Safety bloods and urinalysis~12-lead ECG~Vital signs"|Participants will be followed until follow up visit, 6-11 days after dosing||||participants|||Number
1332706|NCT02054715|Other Pre-specified|To Explore the Effects of Intervention Assignment on Clinical Trial Participation.|Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates. To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate.|Day 49-56|The population for this outcome is 192 (PE) + 170 (MP) = 362 Note: There were 3 individuals (MP) who did not answer this question. This is defined as follow-up 2 (Day 49-56).|||Participants|||Count of Participants
1332707|NCT02054715|Secondary|The Decisional Conflict Scale (DCS)|The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision. In the present study, it will be keyed to the decision about therapeutic clinical trial participation. Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale. Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict.|Day 49-56|The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).|||Percentage of DCS (0 - 100)||Standard Error|Mean
1332722|NCT02054572|Secondary|Number of Participants With Anti-etelcalcetide Antibodies|The presence of anti-etelcalcetide antibodies was assessed and confirmed using a dual-flow cell biosensor immunoassay at baseline (day -1) and at the end of study visit (day 39).|Day -1 and day 39|Participants who received any amount of [¹⁴C]etalcalcetide|||participants|||Number
1332708|NCT02054715|Secondary|The Decision Regret Scale (DRS)|The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five. The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret. Higher scores are worse.|Day 49-56|The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).|||percentage of DRS (0 - 100)||Standard Error|Mean
1332709|NCT02054715|Primary|Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale|Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision. Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal. Larger number is better. All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared).|Day 3 to 7|There were 219 (PE) + 199 (MP) = 418 at Baseline. The population for this outcome is 211 (PE) + 192 (MP) = 403 This is defined as follow-up 1 (Day 3-7).|||percentage of PDMS (0 - 100)||Standard Error|Mean
1332710|NCT02054702|Secondary|Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score|The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1332711|NCT02054702|Secondary|Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score|"The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject’s quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 not well at all to 5 very well. The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant."|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1332712|NCT02054702|Secondary|Response Rate by Study Week|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||percentage of participants|||Number
1332713|NCT02054702|Secondary|Mean Change in Clinical Global Impression–Improvement (CGI-I) Score at Week 6|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||Units on a scale||Standard Deviation|Mean
1332714|NCT02054702|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||Units on a scale||Standard Error|Least Squares Mean
1332715|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
1332723|NCT02054572|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event (TRAE) is any adverse event (AE) that per investigator review has a reasonable possibility of being caused by the investigational product.|From first dose of etelcalcetide to day 39|Participants who received any amount of [¹⁴C]etalcalcetide|||participants|||Number
1332716|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Identification Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
1332717|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Detection Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
1332718|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment.|||z-score||Standard Error|Least Squares Mean
1332719|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery of Early Phase Battery Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
1332720|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Composite Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
1332721|NCT02054702|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a mixed model repeated measures (MMRM) analysis with an unstructured variance covariance structure.|||Units on a scale||Standard Error|Least Squares Mean
1332724|NCT02054572|Secondary|Hemodialysis Extraction Ratio for Etelcalcetide During Hemodialysis on Day 4||Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ratio||Standard Deviation|Mean
1332725|NCT02054572|Secondary|Hemodialysis Clearance of Etelcalcetide During Hemodialysis on Day 4||Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||mL/hr||Standard Deviation|Mean
1332726|NCT02054572|Secondary|Area Under the Curve From Time Zero to 10 Days Post-dose (AUC10d) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng/mL||Standard Deviation|Mean
1332727|NCT02054572|Secondary|Area Under the Curve From Time Zero to 3 Days Post-dose (AUC3d) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng/mL||Standard Deviation|Mean
1332728|NCT02054572|Secondary|Last Observed Plasma Concentration (Clast) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng/mL||Full Range|Median
1332729|NCT02054572|Secondary|Time to Last Observed Plasma Concentration of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||days||Full Range|Median
1332730|NCT02054572|Secondary|Maximum Observed Concentration (Cmax) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng/mL||Standard Deviation|Mean
1332731|NCT02054572|Secondary|Time to Maximum Observed Concentration (Tmax) of Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||minutes||Full Range|Median
1332732|NCT02054572|Primary|Area Under the Venous Plasma Concentration-time Curve Obtained During Hemodialysis on Day 4 for Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng*day/mL||Standard Deviation|Mean
1332733|NCT02054572|Primary|Area Under the Arterial Plasma Concentration-time Curve Obtained During Hemodialysis on Day 4 for Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng*day/mL||Standard Deviation|Mean
1332734|NCT02054572|Primary|Area Under the Curve From Time Zero to 10 Days Post-dose (AUC10d) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng-eq/mL||Standard Deviation|Mean
1332735|NCT02054572|Primary|Area Under the Curve From Time Zero to 3 Days Post-dose (AUC3d) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng-eq/mL||Standard Deviation|Mean
1332736|NCT02054572|Primary|Apparent Terminal Half-life (T½) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||days||Standard Deviation|Mean
1332753|NCT02053753|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event (TRAE) is any treatment-emergent adverse event (AE) that per investigator review has a reasonable possibility of being caused by the investigational product.|From the first dose of denosumab through day 126|All participants who received denosumab|||participants|||Number
1332737|NCT02054572|Primary|Last Observed Plasma Concentration (Clast) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng-eq/mL||Full Range|Median
1332738|NCT02054572|Primary|Time to Last Observed Plasma Concentration of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||days||Full Range|Median
1332739|NCT02054572|Primary|Maximum Observed Concentration (Cmax) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng-eq/mL||Standard Deviation|Mean
1332740|NCT02054572|Primary|Time to Maximum Observed Concentration (Tmax) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma|Total radioactive counts in plasma was determined by accelerator mass spectrometry (AMS).|Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||minutes||Full Range|Median
1332741|NCT02054572|Primary|Cumulative Excretion of Radioactivity|The total radioactivity in excreta (urine and feces) or dialysate and dialysis membrane is expressed as a percentage of the total radioactive [¹⁴C] administered (dose). Total radioactive counts in dialysate, dialyzer, feces, and urine were determined by accelerator mass spectrometry (AMS). Radioactivity excreted during non-sampled days was estimated by interpolation and extrapolation of the measured data.|Day 1 to day 176|Participants who received any amount of [¹⁴C]etelcalcetide with available excretion data|||Percentage of administered dose||Standard Deviation|Mean
1332742|NCT02054481|Secondary|Time to Loss of PASI50 Response|Time to loss of PASI50 response.|From first drug administration until end of follow-up period, up to 48 weeks|FAS|||Days||95% Confidence Interval|Median
1332743|NCT02054481|Secondary|Achievement of sPGA Clear or Almost Clear at Week 12|"Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12.~sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe)."|Week 12|FAS|||Percentage of participants||95% Confidence Interval|Number
1332744|NCT02054481|Secondary|Percentage Change in PASI Score From Baseline at Week 12|"Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS including patients with available data.|||Percentage of PASI score||Standard Deviation|Mean
1332745|NCT02054481|Secondary|Achievement of PASI90 at Week 24|"Percentage of participants who achieved PASI90 at Week 24.~PASI score ranges from 0 (best) to 72 (worst)."|Week 24|FAS|||Percentage of participants||95% Confidence Interval|Number
1332746|NCT02054481|Secondary|Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12|"Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS|||Percentage of participants||95% Confidence Interval|Number
1332747|NCT02054481|Secondary|Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12|"Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS|||Percentage of participants||95% Confidence Interval|Number
1332748|NCT02054481|Secondary|Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24|"Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline, Week 12 and Week 24|FAS|||Percentage of participants||95% Confidence Interval|Number
1332749|NCT02054481|Primary|Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12|"Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|Full Analysis Set (FAS) which included all randomised patients who received at least 1 dose of trial medication and was based on the randomised treatment.|||Percentage of participants||95% Confidence Interval|Number
1332750|NCT02054325|Secondary|The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment|"Skin hyperpigmentation was defined as a brownish hue stain superimposing the previous treated vein site (by visual photographic analyses). Skin hyperpigmentation was firstly evaluated according to its occurence and labeled as Yes or No. Afterwards, when there was stain in the previous treated area, a line was drawn on the stain with Image J software , and the Mean Percent of Skin Hyperpigmentation was proportionaly compared with length of vein treated, previuos mesuread (mean and SD)."|Two months after treatment.||||Percent of Skin Hyperpigmentation||Standard Deviation|Mean
1332751|NCT02054325|Primary|Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.|Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.|Mean Percent of reticular vein disappearance two months after treatment||||% of Reticular Veins that Disappeared||Standard Deviation|Mean
1332752|NCT02053753|Secondary|Number of Participants Who Developed Anti-denosumab Antibodies||Predose on day 1, and days 29, 67 and 127|All participants who received denosumab|||participants|||Number
1340183|NCT01940484|Primary|Mean Hemoglobin Value at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
1332754|NCT02053753|Secondary|Time to Reach Maximum Percent Inhibition (Tmax) of Serum CTX1|Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.|Day 1 predose up to day 127|The pharmacodynamic analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.|||days||Full Range|Median
1332755|NCT02053753|Secondary|Maximum Percent Inhibition (Imax) of Serum CTX1|Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.|Day 1 predose up to day 127|The pharmacodynamic analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.|||percent inhibition||Standard Deviation|Mean
1332756|NCT02053753|Secondary|Area Under the Serum C-telopeptide (CTX1) Percent Inhibition-Time Curve From Time 0 to 18 Weeks Post-dose (AUEC0-18 Weeks)|"Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.~AUEC0-18 weeks was estimated using the linear-log trapezoidal method."|Day 1 predose up to day 127|"The pharmacodynamic (PD) analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.~Eleven participants were excluded from the analysis of AUEC0-18 weeks because no samples after week 16 were collected."|||day*percent inhibition||Standard Deviation|Mean
1332757|NCT02053753|Secondary|Half-life (T1/2) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The PK concentration analysis set; 2 participants were excluded from all PK analyses because insufficient samples were available for calculation of PK variables and a further 11 participants were excluded from the analysis of T1/2 because all samples after week 16 were missing.|||days||Standard Deviation|Mean
1332758|NCT02053753|Secondary|Time to Maximum Observed Concentration (Tmax) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The pharmacokinetic (PK) concentration analysis set includes all participants who received denosumab and had at least one PK sample collected. Two participants were excluded from all PK analyses because insufficient samples were available (≥ 3 missing consecutive samples) for calculation of PK variables.|||days||Full Range|Median
1332759|NCT02053753|Primary|Area Under the Drug Concentration-time Curve From Time 0 to 18 Weeks Post-dose (AUC0-18 Weeks) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The PK concentration analysis set; 2 participants were excluded from all PK analyses because insufficient samples were available for calculation of PK variables and a further 11 participants were excluded from the analysis of AUC0-18 weeks because all samples after week 16 were missing.|||day*μg/mL||Standard Deviation|Mean
1332760|NCT02053753|Primary|Maximum Observed Drug Concentration (Cmax) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The pharmacokinetic (PK) concentration analysis set includes all participants who received denosumab and had at least one PK sample collected. Two participants were excluded from all PK analyses because insufficient samples were available (≥ 3 missing consecutive samples) for calculation of PK variables.|||μg/mL||Standard Deviation|Mean
1332761|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.|||unit on a scale||Standard Deviation|Mean
1332762|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|The EORTC Quality of Life Questionnaire (QLQ-C30) was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.|||unit on a scale||Standard Deviation|Mean
1332763|NCT02053610|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants who were reported as not having started re-treatment or new anti−leukemic therapy were censored at the last visit date they were assessed with regard to start of new treatment or the date of death.|||months||95% Confidence Interval|Median
1332782|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase II)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|11-12 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
1332764|NCT02053610|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1332765|NCT02053610|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with response.|||months||95% Confidence Interval|Median
1332766|NCT02053610|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants who were not reported as having died at the time of the analysis were censored at the date when they were last known to be alive.|||months||95% Confidence Interval|Median
1332767|NCT02053610|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants. Participants were censored at the date of last tumor assessment. In cases where no tumor assessment is available, participants were censored at the date of randomization plus one day.|||months||95% Confidence Interval|Median
1332768|NCT02053610|Secondary|Percentage of Participants With Best Overall Response [Time Frame: Randomization to Clinical Cutoff (Median Observation 14.2 Months)]|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi, PR or nodular Partial Response (nPR). CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1332769|NCT02053610|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. Complete Response (CR) required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. Partial Response (PR) required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 39 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
1332770|NCT02053610|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff (median observation 14.2 months)|ITT participants included all randomized participants.|||percentage of participants|||Number
1332783|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values.|Week 13|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
1332771|NCT02053610|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 18.8 months GClb and 18.6 months RClb)|Intent-to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.|||months||95% Confidence Interval|Median
1332772|NCT02053610|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 39 months)|ITT population included all randomized participants.|||percentage of participants|||Number
1332773|NCT02053610|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 39 months)|Intent--to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.|||months||95% Confidence Interval|Median
1332774|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|9-12 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
1332775|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|3-6 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
1332776|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|9-12 weeks|Participants with usable data included in the results|||accelerometry units/day||Standard Deviation|Mean
1332777|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|3-6 weeks|Participants with usable data included in the results|||accelerometry units/day||Standard Deviation|Mean
1332778|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|11-12 weeks|Participants with usable data included in the results|||Hours/day||Standard Deviation|Mean
1332779|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|5-6 weeks|Participants with usable data included in the results|||Hours/day||Standard Deviation|Mean
1332780|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 13|Participants with usable data included in the results|||pg/mL||Standard Deviation|Mean
1332781|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 7|Participants with usable data included in the results|||pg/mL||Standard Deviation|Mean
1332874|NCT02051595|Primary|Circulating Vancomycin Concentration|Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.|Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)||||µg/mL||Standard Deviation|Mean
1332784|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).|Week 7|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
1332785|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 13|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
1332786|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 7|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
1332787|NCT02053493|Secondary|Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.|Self reported participant preference for study period 1 vs. study period 2.|Week 13|Participants with usable data included in the results|||participants|||Number
1332788|NCT02053493|Secondary|Six Minute Walk Distance (Phase II)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 13|Participants with usable data included in the results|||meters||Standard Deviation|Mean
1332789|NCT02053493|Secondary|Six Minute Walk Distance (Phase I)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 7|Participants with usable data included in the results|||meters||Standard Deviation|Mean
1332790|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase I)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|5-6 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
1332791|NCT02053168|Secondary|Incidence of Seroma||24 Months||||events|||Number
1332792|NCT02053168|Secondary|Number of Related Post-operative Visits Unrelated to Standard of Care||24 Months||||events|||Number
1332793|NCT02053168|Secondary|Number of Study Related Post Operative New Hospital Admissions||24 Months||||events|||Number
1332794|NCT02053168|Secondary|Number of Study Related Post Operative Surgical Procedures||24 Months||||events|||Number
1332795|NCT02053168|Secondary|Length of Hospital Stay|Measured from end of index procedure to hospital discharge|10 Months||||days||Standard Deviation|Mean
1332796|NCT02053168|Secondary|Surgical Procedure Time|Measured from incision to closure (skin to skin).|Duration of index procedure (mean of 242.5 mins)||||minutes||Standard Deviation|Mean
1332797|NCT02053168|Secondary|Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)|Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.|Baseline and 24 months postoperative|All participants with non-missing values at both baseline and respective post procedure assessment.|||units on a scale||Standard Deviation|Mean
1332798|NCT02053168|Secondary|Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)|Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.|Baseline and 24 months postoperative|All participants with non-missing values at both baseline and respective post procedure assessment.|||units on a scale||Standard Deviation|Mean
1332799|NCT02053168|Secondary|Carolinas Comfort Scale (CCS) Total Score - Change From Baseline|The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.|Baseline and 24 months postoperative|All participants with non-missing values at both baseline and respective post procedure assessment.|||units on a scale||Standard Deviation|Mean
1332800|NCT02053168|Secondary|Number of Participants With Device Related Adverse Events|In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.|24 Months||||Participants|||Count of Participants
1332919|NCT02047747|Secondary|Treatment-emergent Adverse Events||End of Treatment (4-6 weeks after permanent discontinuation of study treatment for any reason)|The study was terminated due to slow enrollment. Please see adverse event section for additional information.||||||
1332801|NCT02053168|Primary|Number of Participants With Hernia Recurrence|A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.|1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months||||Participants|||Count of Participants
1332802|NCT02052895|Primary|Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis|For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.|Up to 7 days|Out of 196 Sepsis/SIRS patients, 6 were excluded due to inclusion/exclusion criteria violation and 4 were excluded due to insufficient data for Sepsis/SIRS adjudication|||probability||95% Confidence Interval|Least Squares Mean
1332803|NCT02052752|Secondary|To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Units on a scale||Standard Deviation|Mean
1332804|NCT02052752|Secondary|To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Units on a scale||Standard Deviation|Mean
1332805|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion’s diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion’s widest or highest points.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Percentage change||Standard Deviation|Mean
1332806|NCT02052752|Secondary|To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Units on a scale||Standard Deviation|Mean
1332807|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion’s swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion’s highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant|Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Percentage change||Standard Deviation|Mean
1332808|NCT02052752|Primary|To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.|The Investigator assessed and score each target lesion’s swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion’s highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure|Baseline to Day 4|The analysis population consists of the intent-to-treat (ITT) population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Percentage change||Standard Error|Mean
1332809|NCT02052661|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
1332810|NCT02052661|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0–30) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
1332920|NCT02047747|Primary|Intra-cranial Objective Response Rate|Intra-cranial objective response rate at 2 months as assessed by the Response Assessment in Neuro-oncology (RANO) criteria|2 months|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data not available.||||||
1332811|NCT02052661|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
1332812|NCT02052661|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
1332813|NCT02052661|Secondary|Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix-B Kinder Vaccine.|The amnestic response to the challenge dose was defined as: for initially seronegative subjects, antibody concentration ≥ 10mIU/mL; for initially seropositive subjects, antibody concentration at least four times the pre-challenge antibody concentration.|One month after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Subject|||Number
1332814|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|1 month after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Subject|||Number
1332815|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|Before the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix hexa during first two years of life, for whom the serological results were available.|||Subject|||Number
1332816|NCT02052661|Secondary|Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.|Before (PRE) and 1 month after (POST) the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix hexa during first two years of life, for whom the serological results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1332817|NCT02052661|Primary|Anti-HBs Immune Response|Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.|One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Subject|||Number
1332818|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose|PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|1 hour post loading dose|10 patients were included in the PD analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. Out of the 10 patients in the PD analysis, 1 patient in Ticagrelor group does not have PRU value at 1 hour post loading dose.|||PRUs||Standard Deviation|Mean
1332819|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose|PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|0.5 hours post loading dose|10 patients were included in the pharmacodynamic (PD) analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. 3 out 13 randomized pateints are excluded (1 patient without any PRU data, 2 pateints with protocol deviations)|||PRUs||Standard Deviation|Mean
1332820|NCT02052596|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to study end (Day 0 to Month 14)|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1332821|NCT02052596|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1332921|NCT02047500|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)||Baseline up to Day 30 after the last dose of study treatment|||||||
1332822|NCT02052596|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.|From first vaccination up to study end (Day 0 to Month 14)|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1332823|NCT02052596|Secondary|Number of Days With Solicited Symptoms|"The number of days with local and general symptoms have been assessed during the solicited post-vaccination period.~0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses"|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Days|Doses with the symptom|Inter-Quartile Range|Mean
1332824|NCT02052596|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose|"Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination.~0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses"|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1332825|NCT02052596|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine|"Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm).~0 implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups.~3. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses."|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1332826|NCT02052596|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose|"Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm).~0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses"|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1332827|NCT02052596|Primary|Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens|Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|At 1 month post-Dose 1 (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1332828|NCT02052596|Primary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens|Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|At 1 month post-Dose 1 (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1332829|NCT02052596|Primary|Antibody Concentrations Against Glycoprotein E (Anti-gE)|Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.|At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1332830|NCT02052596|Primary|Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group|"This outcome was required only for the GSK1437173A Group. Vaccine response defined as:~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At 1 month post-Dose 2 (Month 3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available, only for subjects in the GSK1437173A Group.|||Participants|||Count of Participants
1332894|NCT02050321|Primary|Rate of Development of cSCC at 6 Months (Biopsy Confirmed).||6 months post treatment|Per the PI: There is no measurable or interpretable data for this study. Only two patients were enrolled before the study closed to accrual due to recent FDA approvals of drugs for melanoma.Patients were removed from protocol prior to reaching data points or the completing the study.||||||
1332831|NCT02052544|Primary|Overall Sensitivity and Specificity of Pefakit and Hemosil.|Sensitivity is the proportion of positive cases identified as positive. Specificity is the proportion of negative cases identified as negative. The Sensitivity and Specificity of Pefakit and Hemosil were calculated for the overall study population and separately for each of the three medical centers. Sensitivity and Specificity of Pefakit and Hemosil were each assessed relative to the reference method (Biophen)|within 2 - 4 days|AVS (all valid subjects) population: All valid subjects with no major deviation affecting outcome.413 samples total analyzed|||percentage of cases||95% Confidence Interval|Number
1332832|NCT02052466|Secondary|Passive Shoulder Range of Motion - External Rotation|External rotation|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
1332833|NCT02052466|Secondary|Passive Shoulder Range of Motion - Abduction|Abduction|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
1332834|NCT02052466|Secondary|Passive Shoulder Range of Motion - Flexion|Flexion|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
1332835|NCT02052466|Secondary|Active Shoulder Range of Motion - External Rotation|External rotation|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
1332836|NCT02052466|Secondary|Active Shoulder Range of Motion - Abduction|Abduction|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
1332837|NCT02052466|Secondary|Active Shoulder Range of Motion - Flexion|Flexion|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
1332838|NCT02052466|Secondary|Shoulder Strength - External Rotation|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
1332839|NCT02052466|Secondary|Shoulder Strength - Internal Rotation|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
1332840|NCT02052466|Secondary|Shoulder Strength - Abduction|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
1332841|NCT02052466|Secondary|Shoulder Strength - Flexion|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
1332842|NCT02052466|Secondary|Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)|"The Penn Shoulder Score is a shoulder-specific patient reported outcome measure. Best possible score is 100; worst possible score is 0. There are 3 sub-scores: pain (3 questions, 30 possible points), satisfaction (1 question, 10 possible points), and function (20 questions, 60 possible points). Total score is the sum of the 3 sub-scores. For all sub-scores, higher is better.~The pain questions are based on a 10-point numeric rating scale. Points are added for the pain sub-score.~The satisfaction question asks the patient to rate their satisfaction with their shoulder. It is based on a 10-point numeric rating scale, with 0 as not satisfied and 10 as very satisfied.~The function sub-score has 20 questions concerning activities of daily living. The response options are: 0 (can't do at all), 1 (can do with much difficulty), 2 (can do with some difficulty) and 3 (can do with no difficulty). If all activities can be done without difficulty, a score of 60 is achieved."|At least 24 months after reverse TSA||||Scores on the Penn Shoulder Score scale||Standard Deviation|Mean
1332843|NCT02052466|Primary|Actual Versus Predicted Scapular Notching|At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.|At least 24 months after reverse TSA|Patients who had video motion analysis of their range of motion at minimum 2 year follow-up|||percentage of accurate predictions|||Number
1332844|NCT02052440|Secondary|Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group.|The null hypotheses of no difference in the cumulative inpatient dosages of symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. Total benzodiazepine administration received from 0 to 72 hours was summed for each patient in each arm. A mean of this cumulative dose was then calculated for each arm and is reported below.|72 hours|Cumulative dose of symptom driven benzodiazepine|||Milligram of Diazepam||Standard Deviation|Mean
1332845|NCT02052440|Secondary|Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group|The null hypotheses of no difference in the maximum dose of inpatient symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. All maximum doses for each treatment arm given anytime between 0 and 72 hours were recorded and a mean calculated for each treatment arm.|72 hours|Maximum dose of symptom driven benzodiazepine|||Milligram of Diazepam||Standard Deviation|Mean
1332846|NCT02052440|Secondary|Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .|Severity of alcholol withdrawal will be assessed by monitoring SEWS scores in both baclofen and placebo group. This score is reported as a cumulative unit on scale ranging from 0 to 23. A value of 1-6 represents mild alcohol withdrawal, 7-12 moderate and >12 severe. Values will be measured 24 hours, 48 hours and 72 hours. A mean of these values was calculated.|Over 72 hours||||Unit on Scale||Standard Deviation|Mean
1332847|NCT02052440|Primary|Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS).|Prevention of progression to Severe Alcohol withdrawal as assessed by Severity of Ethanol Withdrawal Score (SEWS). A score of > 7 represents moderate alcohol withdrawal and a score > 12 severe alcohol withdrawal. Reported below as number of patients in each group progressing to moderate or severe alcohol withdrawal as assessed by SEWS score.|Within 72 hours||||Participants|||Count of Participants
1332922|NCT02047500|Secondary|Tumor Metabolic Response Assessed by Positron Emission Tomography (PET) Scans According to European Organization for Research and Treatment of Cancer (EORTC) Criteria||Baseline and 8 weeks after Day 1 of Cycle 1|||||||
1332848|NCT02052414|Other Pre-specified|Patient Global Impression of Change (PGIC)|Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|15 Weeks.||||units on a scale||Standard Deviation|Mean
1332849|NCT02052414|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status.|15 weeks.|FM patients who took study medication.|||units on a scale||Standard Deviation|Mean
1332850|NCT02052414|Secondary|Self Reported Side Effects.|Side / adverse effects were assessed at each follow up visits and resulted are as follows.|15 Weeks|Subject who experienced pain, acute delirium, symptoms related to adhesions due to prior surgical procedures, extremity swelling, and possible drug interactions discontinued medications. Other reported side effects dissipated after subjects reached therapeutic dose of 1800mg of study medication taken at bedtime.|||participants|||Number
1332851|NCT02052414|Secondary|Medical Outcome Study (MOS) Sleep Questionnaires|"Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas.~Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5)."|15 weeks||||Hours||Standard Error|Mean
1332852|NCT02052414|Primary|Numeric Pain Rating System (NPRS)|Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable).|15 weeks|All subjects had diagnosis of fibromyalgia and met the inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
1332853|NCT02052141|Secondary|Number of Participants With C1 Esterase Inhibitor (C1 INH) Antibodies in Plasma|The presence of C1 INH antibodies in plasma samples was determined using a proprietary enzyme-linked-immunosorbent-assay. Number of participants with C1 INH Antibodies was reported.|Pre-dose, 1 week post treatment (Week 13, Week 25) and 1 month post treatment follow-up (Week 28)|Safety set included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
1332854|NCT02052141|Secondary|Plasma Concentration of Complement C4|Concentration of Complement C4 in plasma was determined using an automated nephelometric assay.|Pre-dose and 1 h post-dose at Week 1 (Dose 1) and Week 6 (Dose 12); Pre-dose, 1, 2, 4 and 8 h post-dose at Week 12 (Dose 24) of each intervention period|PK set consisted of all pariticipants in the safety set with no major deviations related to investigational product intake and evaluable PK profiles.|||Milligram per liter (mg/L)||Standard Deviation|Mean
1332855|NCT02052141|Secondary|C1 Esterase Inhibitor (C1 INH) Functional Activity in Plasma|The functional activity of C1 INH in plasma samples was determined by a chromogenic assay.|Pre-dose and 1 h post-dose at Week 1 (Dose 1) and Week 6 (Dose 12); Pre-dose, 1, 2, 4 and 8 h post-dose at Week 12 (Dose 24) of each intervention period|PK set consisted of all pariticipants in the safety set with no major deviations related to investigational product intake and evaluable PK profiles.|||Units per milliliter (U/mL)||Standard Deviation|Mean
1332856|NCT02052141|Secondary|Plasma Concentration of C1 Esterase Inhibitor (C1 INH) Antigen|C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.|Pre-dose and 1 hour (h) post-dose at Week 1 (Dose 1) and Week 6 (Dose 12); Pre-dose, 1, 2, 4 and 8 h post-dose at Week 12 (Dose 24) of each intervention period|Pharmacokinetic (PK) set consisted of all pariticipants in the safety set with no major deviations related to investigational product intake and evaluable PK profiles.|||Gram per liter (g/L)||Standard Deviation|Mean
1332857|NCT02052141|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Dose Group|An adverse event (AE) was any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant participating in a clinical study with the sponsor’s product, regardless of causal relationship. TEAEs were defined as events that started or worsened on or after the date and time of the first dose of investigational product and up to 7 days after the last dose of investigational product.|From start of study treatment up to 25 weeks|Safety set included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
1332858|NCT02052141|Secondary|Normalized Number of Angioedema Attacks Per Month Requiring Acute Treatment in a Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Attacks that began then appeared to resolve and then reappeared without a symptom-free calendar day reported after the appearance of resolution were considered 1 attack. Any events of swelling due to trauma or symmetrical nonpainful swelling of the lower extremities were not considered an angioedema attack. The number of attacks requiring acute treatment was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From start of treatment up to 12 weeks during each intervention period|FAS included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Angioedema attacks per month||Standard Deviation|Mean
1332895|NCT02050048|Secondary|Number of Participants With Adverse Events Related to Fluid Overload|A portion of the study will assess whether there is a significant risk of adverse events related to fluid overload states in the high volume (HV) intervention arm. We anticipate the rate of adverse events in patients randomized to the HV arm to be small. By using more modest, weight based regimens, we aim to optimize benefit while eliminating overly aggressive fluid administration and causing undue harm.|Phase II portion (~1 year)|||||||
1332859|NCT02052141|Secondary|Cumulative Daily-severity Score of Angioedema Attacks Normalized Per Month in a Treatment Period|Severity of the angioedema attack sign/symptom was characterized as None: no symptom; Mild: noticeable but easily tolerated by the participant and did not interfere with routine activities; Moderate: interfered with the participant’s ability to attend school or participate in family life and social/recreational activities; Severe: significantly limited the participant’s ability to attend school or participate in family life and social/recreational activities. Symptom severity score was assigned as Mild = 1, Moderate = 2 and Severe = 3. Cumulative daily-severity score was the sum of the severity scores recorded for every day of reported symptoms in a treatment period. Cumulative daily-severity score normalized per month [(raw score/number of days of participation in that treatment period)*30.4] was reported here. Cumulative daily-severity score normalized per month ranged from 0 to 15.6 and higher scores represent worse symptoms.|From start of treatment up to 12 weeks during each intervention period|FAS included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1332860|NCT02052141|Secondary|Cumulative Attack-severity Score of Angioedema Attacks Normalized Per Month in a Treatment Period|Severity of the angioedema attack sign/symptom was characterized as None: no symptom; Mild: noticeable symptom but easily tolerated by the participant and did not interfere with routine activities; Moderate: symptom interfered with the participant’s ability to attend school or participate in family life and social/recreational activities; Severe: symptom significantly limited the participant’s ability to attend school or participate in family life and social/recreational activities. Symptom severity score was assigned as Mild = 1, Moderate = 2 and Severe = 3. Cumulative attack severity score was the sum of the maximum symptom severity scores recorded for each angioedema attack in a treatment period. Cumulative attack-severity score normalized per month [(raw score/number of days of participation in that treatment period)*30.4] was reported here. Cumulative attack-severity score normalized per month ranged from 0 to 10.4 and higher scores represent worse symptoms.|From start of treatment up to 12 weeks during each treatment period|FAS included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1332861|NCT02052141|Primary|Normalized Number of Angioedema Attacks Per Month in a Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Attacks that began then appeared to resolve and then reappeared without a symptom-free calendar day reported after the appearance of resolution were considered 1 attack. Any events of swelling due to trauma or symmetrical nonpainful swelling of the lower extremities were not considered an angioedema attack. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From start of treatment up to 12 weeks during each treatment period|Full Analysis Set (FAS) included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Angioedema attacks per month||Standard Deviation|Mean
1332862|NCT02052011|Primary|Coronary Flow Reserve|Compare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control. This is the ratio between stress and rest myocardial blood flow in response to stress.|4 weeks||||ratio||Standard Deviation|Mean
1332863|NCT02051816|Secondary|Grade View of the Glottis|Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt. Higher grades on the 1-4 scale indicate worse glottic views.|1 hour||||units on a scale||Standard Deviation|Mean
1332864|NCT02051816|Secondary|Number of Esophageal Intubations Per Group|Number of esophageal intubations Per Study Group|1 hour||||number of esophageal intubations|||Number
1332865|NCT02051816|Secondary|Ventilator-free Days|Number of days alive and free of mechanical ventilation after endotracheal intubation|28 days||||DAYS||Standard Deviation|Mean
1332866|NCT02051816|Secondary|Adjusted Lowest Arterial Oxygen Saturation During Procedure|Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs.|1 hour||||PERCENT SATURATION||Standard Deviation|Mean
1332867|NCT02051816|Secondary|ICU-mortality|Death from any cause in the ICU and at anytime after the procedure|28 days||||Participants|||Count of Participants
1332868|NCT02051816|Secondary|Procedure-related Mortality|Death within 1 hour of beginning the procedure|1 hour||||Participants|||Count of Participants
1332869|NCT02051816|Primary|Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death).|The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death).|1 hour||||percent arterial oxygen saturation||Inter-Quartile Range|Median
1332870|NCT02051816|Primary|Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator’s Past Number of Procedures With the Equipment Used.|The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator’s past number of procedures with the equipment used.|1 hour||||participants|||Number
1332871|NCT02051790|Primary|Agreement Between Expert Panel and Clinical Practice Reads|Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.|Scan acquired 50-60 minutes post injection||||Weighted Kappa statistic||95% Confidence Interval|Number
1332872|NCT02051686|Secondary|Number of Participants That Required an Allogenic Transfusion||Perioperative (hospitalized period)||||Participants|||Count of Participants
1332873|NCT02051686|Primary|Intra-operative Blood Loss||Day of Surgery||||Milliliters||Standard Deviation|Mean
1332875|NCT02051426|Primary|Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours|RAVLT measures short term verbal memory, verbal learning, susceptibility to (proactive and retroactive) interference, retention of information after a certain period of time during which other activities are performed and recognition memory. The test consists of a list of 15 common nouns, which are read to the subject in five consecutive trials (trials 1 through 5); each reading is followed by a free-recall task. In trial 6, an interface list of 15 new common nouns is presented, followed by free recall of these new nouns. In trial 7, without additional reading, subjects are again asked to recall the first list. Twenty minutes later, without an additional reading, subjects are asked to recall once more the first list (trial 8). The RAVLT score range from 0-90 correctly recalled words. For trial 7 the score ranges from 0 to 15 correctly recalled words.|Baseline, 2 hours post intervention||||units on a scale||Standard Deviation|Mean
1332876|NCT02051426|Primary|Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours|"The d-prime score is a score given to each participant on a scale of 0.0 - 1.0 in which discrimination sensitivity is measured. A score of 0 equates to no sensitivity whereas a score of 1.0 equates to perfect sensitivity."|Baseline, 2 hours post intervention||||units on a scale||Standard Deviation|Mean
1332877|NCT02051426|Primary|Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours|The subject was asked to point on the VAS scale according to his anxiety level. VAS anxiety scale 0 to 10 ( 0 [no anxiety] to 10 [maximum anxiety] ).|Baseline, 2 hours post intervention||||units on a scale||Standard Deviation|Mean
1332878|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-Dose|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan=abnormal clinically significant.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
1332879|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
1332880|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis. LLN=lower limit of normal. ULN=upper limit of normal.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
1332881|NCT02051335|Secondary|Percentage of Participants Who Experience at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any adverse event, regardless of relationship to study drug that occurs or worsens after the first dose of study drug and no more than 14 days after the last dose of study drug.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
1332882|NCT02051335|Secondary|Change From Baseline in the Spatial Working Memory (SWM) Total Number of Between Errors at the 10-Box Stage and the 12-Box Stage at All Time-points Assessed After Scopolamine Administration|SWM assesses the ability to retain spatial information and manipulate it in working memory. In this task, colored boxes are shown on the screen, and participants must search for blue tokens by touching the colored boxes to open them. When the blue token has been found the participant has to place the token in the black column (‘home’) on the right-hand side of the screen by touching this area. The participant must not return to a box where a token has previously been found. The task becomes more difficult as the number of boxes increases (one trial at each of 6-box and 8-box stages; three trials at each of 10-box and 12-box stages). Between Errors is the total number of times the participant revisits a box in which a token has previously been found in the same problem. The possible range of errors is 0 (best) to 1040 (worst). Lower number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||errors||Standard Deviation|Mean
1332883|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) Median Latency at All Time-points Assessed After Scopolamine Administration|RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. Assessment will be based on a median latency. The possible range for RVP median latency is 100 (worst) to 1900 (best). Higher number in the test indicates a better outcome. “Median latency” is a measure captured by computerized test measure and given as “one” time value (between 100 and 1900). The “mean” of these values is presented.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||msec||Standard Deviation|Mean
1332893|NCT02050321|Secondary|Adverse Events|The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Baseline through 30 Days post Treatment|Per the PI: Although there is no measurable or interpretable data for this study. One patient had higher than normal liver lab results and was removed from study treatment due to grade and severity. Patient safety was evaluated.|||Participants|||Count of Participants
1332884|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) A Prime Signal Detection at All Time-points Assessed After Scopolamine Administration|RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. A prime (A′) is a signal detection measure that reflects target sensitivity regardless of the participant’s tendency, or bias, to respond. Detection sensitivity for RVP A’ prime: 0 to 1. Lower numbers in the test indicates worsening in the performance.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||unitless||Standard Deviation|Mean
1332885|NCT02051335|Secondary|Change From Baseline in the Paired Associates Learning (PAL) Total Number of Errors Adjusted at All Time-points Assessed After Scopolamine Administration|PAL assesses visuospatial associative learning and memory. Boxes are displayed on the screen and open in a randomised order to reveal a number of patterns. The patterns are then displayed in the middle of the screen, one at a time, and the participant must touch the box where the pattern was originally located. If the participant makes an error, the patterns are re-presented to remind the participant of their locations. If the participant has not responded correctly within six attempts, ie, one presentation and five re-presentations, the task is terminated. As the task progresses the difficulty level increases with the number of patterns to be remembered. For participants who fail to complete all levels, an adjusted total is calculated that takes into account errors predicted in the stages that were not attempted. The possible range for total errors is 0 (best) to 91 (worst). Fewer number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||errors||Standard Deviation|Mean
1332886|NCT02051335|Secondary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate and Delayed Recall at 2 and 4 Hours After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||correct responses||Standard Deviation|Mean
1332887|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||correct responses||Standard Deviation|Mean
1332888|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Delayed Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period. Baseline is defined as the assessment 1 hour before roflumilast/donepezil administration (3 hours before scopolamine administration).|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||correct responses||Standard Deviation|Mean
1332889|NCT02051296|Primary|Time to Pain Resolution|the time until patient answers no pain at surgical site for three consecutive days|up to 365 days|94 CTR enrolled and randomized, 83 completed and reached endpoint (43 in minocycline group and 40 in placebo group) 37 TFR enrolled and randomized, 31 completed and reached endpoint (15 in minocycline group and 16 in placebo group)|||DAYS||Full Range|Median
1332890|NCT02050334|Secondary|Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.|||hours||Standard Error|Mean
1332891|NCT02050334|Secondary|Pharmacokinetics (PK)|Time to Reach Maximum Observed Plasma Concentration (Tmax)|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.|||hours||Standard Error|Mean
1332892|NCT02050334|Primary|Unsolicited Adverse Event Reports|Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.|Minimum of 24 hours after each dose.|All 18 subjects analyzed, per protocol.|||Unsolicited Adverse Event Reports|||Number
1332896|NCT02050048|Primary|Development of Post-ERCP Pancreatitis|Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.|Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure||||participants|||Number
1332897|NCT02049931|Secondary|the Progression of Body Compression Ratio Over All Follow-up Assessments|The anterior body compression ratio was assessed by calculating the ratio between the vertical height of the most compressed anterior section of the injured vertebral body and the posterior vertebral body height at that level|2 weeks, 6 weeks, and 12 weeks after compression fracture||||ratio||Standard Deviation|Mean
1332898|NCT02049931|Secondary|General Health Status|The general health status was assessed with use of the Short Form-36 Health Survey (SF-36) at the initial enrollment and 12 weeks after compression fracture.The raw scores for the eight subscales and the two summaries of the SF-36 (Physical Function,Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotion, and Mental Health, as well as the Physical Component Summary [PCS] and the Mental Component Summary [MCS]) were transformed into norm-based 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, and the higher the score the less disability. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|at the initial enrollment and 12 weeks after compression fracture||||units on a scale||Standard Deviation|Mean
1332899|NCT02049931|Secondary|Oswestry Disability Index (ODI)|The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).|at 2 weeks, 6 weeks, and 12 weeks after compression fracture.||||units on a scale||Standard Deviation|Mean
1332900|NCT02049931|Secondary|Visual Analog Pain Scale (VAS) for Back Pain|The VAS for back pain comprised a 10-cm line with “none” (0) on one end and “disabled pain” (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score.|2 weeks, 6 weeks, 12 weeks after injury||||units on a scale||Standard Deviation|Mean
1332901|NCT02049931|Primary|Oswestry Disability Index (ODI) at 12 Weeks|The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).|12 weeks after injury||||units on a scale||95% Confidence Interval|Mean
1332902|NCT02049450|Secondary|Pharmacokinetics (PK) Parameter of Cmax|"Cmax (1h) of INC424 by actual dose administered from 10mg bid to 20mg bid. Plasma PK samples were collected at Day 1, Week 2, and Week 12. Cmax was collected within a +/- 1 hour post dose.~n= number of patients with valid PK samples as per definition of the PK analysis set."|Day 1, Week 2 (Day 15), Week 12 (Day 85)|The PK analysis set includes all patients with at least one evaluable PK sample at any visit.|||ng/mL||Standard Deviation|Mean
1332903|NCT02049450|Secondary|Pharmacokinetics (PK) Parameter of Cmin|C min of INC424 by actual dose administered from 10mg bid to 20mg bid. Plasma PK samples were collected at Day 15 (Week 2), and Day 85 (Week 12). Cmin was collected immediately prior to dosing. n= number of patients with valid PK samples as per definition of the PK analysis set.|week 2, week 12|The PK analysis set includes all patients with at least one evaluable PK sample at any visit.|||ng/mL||Standard Deviation|Mean
1332904|NCT02049450|Secondary|Percentage Change in Spleen Length (cm) Below the Left Coastal Margin|Change of spleen length from baseline over time measured by palpitation by time|baseline, weeks 1,2,3,4,6,12,18,24,30|The Safety Set consists of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.|||percentage change in spleen length||Standard Deviation|Mean
1332905|NCT02049450|Secondary|Percentage Change in Mean Pre-transfusion Hemoglobin by 6 Week Time Intervals|Change from baseline in pre-transfusion hemoglobin levels|baseline, weeks 0 - 30|The Safety Set consists of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.|||percentage change of hemoglobin levels||Standard Deviation|Mean
1332906|NCT02049450|Secondary|Percentage Change in Spleen Volume (cm3)|Change of spleen volume from baseline at week 12 and week 30 as measured by magnetic imaging resonance (MRI) or computed tomography (CT).|baseline, week 12, week 30|The Safety Set consisted of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.|||percentage change||Standard Deviation|Mean
1332907|NCT02049450|Primary|Change of Hematocrit Adjusted Volume of Red Blood Cells (RBC)|Change of RBC transfusion requirement measured as percent change of the hematocrit-adjusted volume of transfused RBC and observed during within on-treatment interval (any time-points of RBC transfusion between week 6 and week 30 driven by the individual patient’s need) compared to baseline (defined by pre-treatment interval between Week – 24 to start of treatment).|week 6 to week 30 interval|Per-Protocol Set (PPS) consisted of a subset of patients in the Safety Set who were compliant with requirements of the Study Protocol. Patients were excluded from the PPS if: they had no or incomplete history of RBC transfusions within 24 weeks prior to the first dose of ruxolitinib or discontinued treatment with ruxolitinib prior to Week 18.|||% change of hematocrit-adjusted volume||Standard Deviation|Mean
1332908|NCT02049385|Primary|MADRS Change at Day 7|Change in Montgomery Asberg Depression Rating Scale (MADRS) from baseline to 7 days post-treatment. The range of values is from 0 – 60, with a higher score indicating increased depressive symptoms. A score of 7-19 indicates mild depression; 20-34 indicates moderate depression; >34 indicates severe depression.|7 days|The analysis included those subjects who started treatment and completed treatment with Diazoxide or Placebo through at least 7 days.|||percentage of change in units of scale||Full Range|Median
1332909|NCT02049151|Secondary|Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI−CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI−CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported.|Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months|Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline.|||subjects|||Number
1332910|NCT02049151|Secondary|Time to Progression (TTP)|TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death.|Time from date of randomization until PD, assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).||||||
1332911|NCT02049151|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment.|Time from date of randomization until PD or death, assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).||||||
1332912|NCT02049151|Secondary|Time to Symptom Progression (TTSP)|TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks.|Time from date of randomization until progressive disease (PD), assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).||||||
1332913|NCT02049151|Primary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.|Time from date of randomization until death, assessed maximum up to 16 months|Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline. Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).|||subjects|||Number
1332914|NCT02048904|Primary|Change in Microalbuminuria Level|Decrease in microalbuminuria level|Six months|Zero participants were analyzed due to early termination of study related to technical/operational difficulties at the study site.||||||
1332915|NCT02048891|Secondary|Patients Comfort During the Luteal Phase||During 2 weeks from day of oocyte retrieval|||||||
1332916|NCT02048891|Primary|Fetal Heart Activity 1 Month After Oocyte Retrieval|Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval|1 month after oocyte retrieval||||participants with fetal heart activity|||Number
1332917|NCT02048241|Primary|Number of Participants That Were Responders|Overall response to treatment is defined as at least a 70% decline in both the Modified Overt Aggression Scale (MOAS) score and the Symptom Checklist-6 (SCL-6) from randomization to end of study. The MOAS measures the severity of explosive overt aggression. The score can range from 0 (no overt aggressive) and it has no theoretical upper limit (incidents could be too many to count). The higher the score, the more serious the aggression; the lower the score, the less serious the aggression. Response to treatment is defined as a 70% or more reduction in the MOAS at the end of the study. The SCL-6 uses 6 subscale items from the larger SCL that measure hostility or irritability on a scale of 1 (not at all) - 5 (definitely). The raw score ranges from 6 (no irritability) to 30 (severe irritability). The lower the score is, the better the outcome. The % decline vary from 0%-100%. A 70% or more decline in the SCL-6 score at the end of study is a response.|up to 8 weeks||||Participants|||Count of Participants
1332918|NCT02048072|Primary|RMSSD Normal Breathing|"Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR or pulse intervals.~It is calculated as the square root of the mean of the squares of the successive differences between adjacent RR intervals or pulse intervals.~In this study pulse intervals were measured non-invasively during five minutes, while subjects were supine, breathing regularly.~Measurements were done at two timepoints t=0 and t=4,5hours. RMSSD was compared between these two timepoints."|t-4,5 hours||||milliseconds||95% Confidence Interval|Mean
1332925|NCT02047500|Secondary|Percentage of Subjects With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) Criteria||Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment|||||||
1332926|NCT02047500|Secondary|Progression Free Survival (PFS) Time||Time from enrollment to progressive disease (PD) or occurrence of death due to any cause within 120 days of either first administration of study drug or the last tumor assessment|||||||
1332927|NCT02047500|Primary|Number of Subjects Experiencing Dose Limiting Toxicity (DLT)||Up to Day 28 of Cycle 1|One patient not evaluable as they did not complete cycle 1|||Participants|||Count of Participants
1332928|NCT02047227|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.|15 to 20 days post r-hCG administration (Day 132)|MITT Analysis Set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
1332929|NCT02047227|Secondary|Clinical Pregnancy Rate|Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.|35-42 days post r-hCG administration (Day 154)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
1332930|NCT02047227|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|35-42 days post r-hCG administration (Day 154)|"MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||percent sacs per embryo|||Number
1332931|NCT02047227|Secondary|Live Birth Rate|Live birth rate was defined as the percentage of subjects with at least one live-born neonate.|Approximately 180 days following ongoing pregnancy determination (Day 365)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
1332932|NCT02047227|Secondary|Ongoing Pregnancy Rate|Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).|70 days after embryo transfer (Day 185)|Modified intent-to-treat (MITT) analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
1332933|NCT02047227|Primary|Number of Oocytes Retrieved|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|At approximately 34 to 38 hours after r-hCG administration (Day 113)|Intent-to-treat (ITT) analysis set included all subjects randomized who received at least 1 dose of GONAL-f or Pergoveris.|||oocytes||Standard Deviation|Mean
1332934|NCT02046993|Primary|Comparison Between Mean Home Systolic and Diastolic Blood Pressure HSBP and HDBP Readings at 6 Months Between the Smartphone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|6 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected|||mmHg||Standard Deviation|Mean
1332935|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings at 3 Months Between Smart Phone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|3 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected|||mmHg||Standard Deviation|Mean
1332936|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|baseline|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected|||mmHg||Standard Deviation|Mean
1332937|NCT02046993|Secondary|Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention|This is a 6-items scale for measuring confidence of patients in self management of their chronic disease. Each item has a likert scale from 1 to 10 with 10 as most confident. Higher score indicating higher self-efficacy|6 months||||units on a scale||Standard Deviation|Mean
1332938|NCT02046993|Primary|Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline|At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will meaure blood pressure after 15 minutes rest with validated electronic automated sphygmanometer ( ) . Four blood pressure readings taken at 1 minute interval will done for each subject and the mean of the second and third reading would be used for the primary outcome ,|baseline, 3rd month and 6 month|Intention to treat analysis was used and the last known data were carried forward to replace missing values for drop-outs.|||mmHg||Standard Deviation|Mean
1332939|NCT02046993|Primary|Percentage of Subjects Doing Home BP Monitoring|Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week|Baseline, 3rd month, 6th month||||percentage of subjects doing HBPM|||Number
1332940|NCT02046980|Primary|Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus||2 days|217 patients enrolled in the study but 8 retracted their agreements.|||participants|||Number
1332941|NCT02046863|Primary|Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming|Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.|Within two days of standard clinical DBS programming session||||Percentage change||Standard Deviation|Mean
1332942|NCT02046772|Secondary|Time of Hospitalization|To see if the hospitalization time is shortened or not by the experimental treatment.|Up to 72 hours after the intervention||||participants|||Number
1332943|NCT02046772|Secondary|Number of Adverse Events|To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.|Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge||||participants|||Number
1332944|NCT02046772|Secondary|Greater and Earlier Mobilization Measured by Bromage Scale.|"To assess whether the administration of morphine chloride in addition to a low dose solution of local intradural anaesthetic (bupivacaine) improves the mobilization of the patients after surgery more than the single intradural administration of bupivacaine.~Total Score in the Bromage Scale goes from 1 to 5, where:~1: complete motor blocking - 2: capable to move the feet - 3: moves the feet and bends the knee - 4: raise the leg straight more or less than 30 degrees but no against resistance - 5: raise the leg straight more than 30 degrees against resistance (no motor blocking)"|During the first 24 hours after surgery and at the entry and exit of the resuscitation unit||||units on a scale||Standard Deviation|Mean
1332945|NCT02046772|Primary|Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.|To compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.|Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge||||units on a scale||Standard Deviation|Mean
1332946|NCT02046772|Primary|Measurement of Time to Start the Anaesthetic Effect|To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.|First 20 minutes between administration and beginning of surgery||||minutes||Standard Deviation|Mean
1332947|NCT02046616|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|FACIT-F consisted of 40 questions/statements assessing chronic illness therapy with special emphasis on fatigue over the past 7 days, with each item rated 0 (not at all) to 4 (very much). During score calculations, negatively-worded item scales (e.g., “I have a lack of energy”) were reversed so that higher scores indicated more favorable conditions. The total FACIT-F score was the sum of all item scores and ranged 0-160, and the brief FACIT-F score was the sum of 13 item scores and ranged 0-52, where higher scores indicate greater well-being. Change from baseline was averaged among all participants. Positive values indicate improvement in well-being.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1332948|NCT02046616|Secondary|Compliance With Treatment According to Percentage of Injections Administered|Participants were provided with diary cards to record home injections. Compliance with treatment was calculated individually for each participant as the actual number of injections as a percentage of the planned number of injections (up to the point of discontinuation for those who discontinued study treatment prematurely) and then averaged among all participants.|Baseline up to Week 24|ITT Set|||percentage of injections||Standard Deviation|Mean
1332949|NCT02046616|Secondary|Change From Baseline in HAQ-DI Score|HAQ-DI consisted of 20 questions assessing ADLs in 8 domains (dress/groom, arise, eat, walk, reach, grip, hygiene) with each item rated 0 (no difficulty) to 3 (unable to do). The highest score recorded for any question in a domain determined the score for that domain, unless assistance was required. The total HAQ-DI score was the sum of domain scores divided by the number of domains answered/scored, for a single score range of 0-3, where higher scores indicate increased functional disability. Change from baseline was averaged among all participants. Negative values indicate improvement in ability to perform ADLs.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1332950|NCT02046616|Secondary|Change From Baseline in Patient Global Assessment of RA-Related Pain According to VAS|PGA of RA-related pain was scored 0-100 mm on a VAS, where higher scores indicate greater perceived pain. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA-related pain.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||mm||Standard Deviation|Mean
1333195|NCT02045264|Primary|Time to Peak Plasma Concentration (Tmax) of Icatibant and Metabolites|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||hr||Standard Deviation|Mean
1332951|NCT02046616|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity According to VAS|PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||mm||Standard Deviation|Mean
1332952|NCT02046616|Secondary|Soluble Interleukin-6 Receptor (sIL-6R) Concentration|sIL-6R concentration was determined, averaged among all participants, and expressed in nanograms per milliliter (ng/mL).|Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)|ITT Set|||ng/mL||Standard Deviation|Mean
1332953|NCT02046616|Secondary|Tocilizumab Concentration|Tocilizumab concentration was determined, averaged among all participants, and expressed in micrograms per milliliter (mcg/mL).|Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)|ITT Set. The Analysis was conducted on those participants with quantifiable tocilizumab concentration at the specified assessment.|||mcg/mL||Standard Deviation|Mean
1332954|NCT02046616|Secondary|Number of Participants With Neutralizing Anti-Tocilizumab Antibodies|Participants were evaluated for the presence of anti-tocilizumab antibodies. Confirmatory assays were performed in the case of a positive screen assay result.|Baseline to FU Week 8 (up to 32 weeks overall)|ITT Set|||participants|||Number
1332955|NCT02046616|Secondary|Percentage of Participants With At Least One Adverse Event Leading to Dosage Modification|The percentage of participants with at least one adverse event leading to dose/frequency reduction or temporary dose hold was reported.|Baseline up to Week 24|ITT Set|||percentage of participants|||Number
1332956|NCT02046616|Secondary|Change From Baseline in SJC|SJC was taken as the number of swollen joints out of 28 assessed joints.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||swollen joints|Joints|Standard Deviation|Mean
1332957|NCT02046616|Secondary|Change From Baseline in TJC|TJC was taken as the number of tender joints out of 28 assessed joints.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||tender joints|Joints|Standard Deviation|Mean
1332958|NCT02046616|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)|SDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, physician assessment of disease activity, and laboratory-derived C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total SDAI score range was 0-86, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1332959|NCT02046616|Secondary|Change From Baseline in CDAI at Weeks 2, 4, 8, 16, 20, and 24|CDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1332960|NCT02046616|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response was assessed by change from baseline and absolute DAS28-ESR score. EULAR response classification was as follows: Good (change >1.2 with absolute score </=3.2), Moderate (change >1.2 with absolute score >3.2 or change >0.6 with absolute score </=5.1), None (change </=0.6 or absolute score >5.1). DAS28-ESR was based on TJC, SJC, and PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. The percentage of participants meeting criteria for each level of EULAR response was reported.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set|||percentage of participants|||Number
1332961|NCT02046616|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response|ACR response was assessed on the basis of percent improvement (20% for ACR20, 50% for ACR50, 70% for ACR70) in both TJC and SJC as well as at least three of the following: physician assessment of disease activity, PGA of disease activity, PGA of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either ESR or C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, out of 68 and 66 assessed joints, respectively. PGA and physician assessments were scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity or pain. HAQ-DI was scored using participant responses to 20 questions assessing activities of daily living (ADLs), with total score scale of 0-3, where higher scores indicate increased functional disability. The percentage of participants meeting criteria for each level of ACR response was reported.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set|||percentage of participants|||Number
1332962|NCT02046616|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)-Erythrocyte Sedimentation Rate (ESR) Score|DAS28-ESR was based on TJC, SJC, PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1332963|NCT02046616|Primary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12|CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline, Week 12|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1332964|NCT02046564|Secondary|The Mean Change From Baseline in the Self-rating Version of Montgomery-Åsberg Depression Rating Scale (MADRS-S) Total Score|The MADRS-S is a patient-reported scale based on MADRS, administered to evaluate the level of depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored from 0 to 3, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 27, with higher score indicating worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
1332965|NCT02046564|Secondary|The Mean Change From Baseline in the Apathy Scale (AS) Total Score|The AS consists of 14 items. Items 1-8 are scored as follows: 3= Not at all, 2= Slightly, 1= Some, 0= A lot. Items 9-14 are scored as follows: 0= Not at all, 1= Slightly, 2= Some, 3= A lot. Total score ranges from 0-42, with higher score indicating worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
1332966|NCT02046564|Secondary|The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score|The SASS is a self-rating scale which assesses the social motivation and behavior in participants with depression. The SASS consists of 21 items covering the different aspects of social interactions, global social attitude, and self-perception. Each item is scored from 0 to 3, with higher scores indicating better condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
1332967|NCT02046564|Secondary|The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score|"The HAM-D is a clinician-rated scale which evaluates the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on.~Each item is scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 52, with higher score indicating worse condition."|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
1332968|NCT02046564|Secondary|The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)|The CGI-S Scale is a clinician-rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
1332969|NCT02046564|Secondary|The Clinical Global Impression - Improvement (CGI-I) Improvement Rate|The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient’s condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. CGI-I Improvement Rate is the percentage of subjects whose CGI-I score is 1 or 2.|6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||percentage of participants|||Number
1332970|NCT02046564|Secondary|The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate|"The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.~MADRS Remission Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more and whose MADRS total score is 10 points or less."|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||percentage of participants|||Number
1332971|NCT02046564|Secondary|The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate|"The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.~MADRS Response Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more."|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||percentage of participants|||Number
1332972|NCT02046564|Primary|The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.Summed subscales are combined to compute a total score. Total score ranges from 0 to 60, with higher score indicating worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
1332977|NCT02046369|Secondary|Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score|Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The CGI-BP-S is a three-question clinician-rated assessment of the subject’s current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity.|baseline and week 6|the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
1332978|NCT02046369|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.|ADHD-RS total score: changes from baseline over time -ANCOVA-LS Mean and SE for change from baseline are based on ANCOVA. The Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:% Max = 100 × (Raw Score – Minimum Score) / (Maximum Score – Minimum Score),where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.|baseline and week 6|The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
1332979|NCT02046369|Secondary|Change From Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS) Score as Compared to Placebo.|CGAS Score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures|baseline and week 6|the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
1332980|NCT02046369|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.|"PQ-LES-Q percentage maximum possible score: changes from baseline over time - mixed model for repeated measures~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures"|baseline|the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment on any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
1332981|NCT02046369|Secondary|Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.|PARS score: changes from baseline over time - mixed model for repeated measures-LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6‑17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. The PAR total score over all 7 questions ranges in value from 0 to 35.|baseline and week 6|The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
1332982|NCT02046369|Primary|Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline|"CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.~The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness.~The primary efficacy endpoint will be assessed between the placebo and treatment group."|baseline, Week 6|The ITT population includes all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
1332983|NCT02046265|Primary|Human Papilloma Virus (HPV) Vaccine #1 Acceptance||For each participant, at end of first study visit. Will assess until all subjects enrolled in study.|All participants in the analysis were eligible to recieve the HPV vaccine.|||Participants|||Count of Participants
1332984|NCT02046226|Secondary|Incidence of Complete Wound Closure|number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks.|3 months|Study subjects were not available to provide data when the secondary outcome was to be reported, and thus there are no secondary outcome data to report.||||||
1332985|NCT02046226|Primary|Rate of Wound Healing|Percentage reduction in target wound area (length x width).|3 months|Study subjects were not available to provide data when the primary outcome was to be reported, and thus there are no primary outcome data to report.||||||
1332986|NCT02046200|Secondary|Stress-induced Alcohol Craving|Alcohol Urge Questionnaire (AUQ)|pre-post exposure to an imaginal stress script|The stress paradigm (pre-post exposure to an imaginal stress script) was not implemented from the outset of the study due to feasibility reasons. In particular, the investigators were concerned that the timing of the stress exposure might contaminate the effects of the alcohol administration.||||||
1332987|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Half-life (T1/2)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48||||hours||Standard Deviation|Mean
1332988|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.|||ng*h/mL||Standard Deviation|Mean
1332989|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Time to Cmax (Tmax)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.|||hours||Standard Deviation|Mean
1332990|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Peak Concentration (Cmax)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.|||ng/mL||Standard Deviation|Mean
1332991|NCT02046200|Primary|Adverse Effects|Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion.|During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl|All randomized subjects included.|||adverse effect count|||Number
1332992|NCT02046200|Primary|Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)|Cue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6.|6 hours post-medication administration||||scores on a scale||Standard Deviation|Mean
1332993|NCT02046200|Primary|Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale|Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below.|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
1332994|NCT02046200|Primary|Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale|Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below.|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
1332995|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - High Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Are you high? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
1332996|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - More Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Would you like more of the drug right now? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
1332997|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - Like Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Do you like the effects you are feeling right now? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
1332998|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - Feel Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Do you feel any drug effects? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
1332999|NCT02046200|Primary|Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)|Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree).|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
1333202|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|Baseline||||drinks per drinking day||Standard Deviation|Mean
1333000|NCT02046200|Primary|Diastolic Blood Pressure|"Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).~Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.|||mmHg||Standard Deviation|Mean
1333001|NCT02046200|Primary|Systolic Blood Pressure|"Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).~Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.|||mmHg||Standard Deviation|Mean
1333002|NCT02046200|Primary|Heart Rate|"Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).~During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.|||BPM||Standard Deviation|Mean
1333003|NCT02046148|Secondary|Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum)|"Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross).~Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the median, minimum and maximum."|At Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Sores on a scale||Full Range|Median
1333004|NCT02046148|Secondary|Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation)|"Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross).~Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the mean and standard deviation."|At Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Scores on a scale||Standard Deviation|Mean
1333005|NCT02046148|Secondary|Infants Apgar Scores (Median, Minimum and Maximum)|Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar scores between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.|At 1, 5 and 10 minutes|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Scores on a scale||Full Range|Median
1333006|NCT02046148|Secondary|Infants Apgar Scores (Mean - Standard Deviation)|Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar score between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.|At 1, 5 and 10 minutes|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Scores on a scale||Standard Deviation|Mean
1333007|NCT02046148|Secondary|Birth Length and Head Circumference of Infants (Median - Minimum and Maximum)|Length and head circumference at birth were summarized by reporting the median and minimum and maximum|At birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Centimeter||Full Range|Median
1333008|NCT02046148|Secondary|Birth Length and Head Circumference of Infants (Mean - Standard Deviation)|Length and head circumference at birth were summarized by reporting the mean and standard deviation.|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Centimeter||Standard Deviation|Mean
1333009|NCT02046148|Secondary|Birth Weight of Infants (Median, Minimum and Maximum)|Weight at birth was summarized by reporting the median and the minimum and maximum.|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Kilogram||Full Range|Median
1333010|NCT02046148|Secondary|Birth Weight of Infants (Mean-Standard Deviation)|Weight at birth was summarized by reporting the mean and standard deviation,|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Kilogram||Standard Deviation|Mean
1333041|NCT02045979|Secondary|AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) based on the last observed concentration at time of last measureable concentration (tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation of Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333011|NCT02046148|Secondary|Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Birth through Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Infant Subjects|||Number
1333012|NCT02046148|Secondary|Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Study Day 32 through Day 180 postpartum|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Maternal Subjects|||Number
1333013|NCT02046148|Secondary|Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Study Day 1 through Study Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Maternal Subjects|||Number
1333014|NCT02046148|Secondary|Percentage of Maternal Subjects With Any Unsolicited AEs|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes inter-current illnesses or injuries and exacerbation of pre-existing conditions.|From Study Day 1 through Study Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Maternal Subjects|||Number
1333015|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7|Percentage and frequency of maternal subjects with solicited local and solicited systemic adverse events up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 1-7 (from 6 hours through Day 7 post-vaccination)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
1333016|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 4-7|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
1333017|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 1-3 (from 6 hours through Day 3 post-vaccination)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
1333018|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|Up to 30 minutes post-vaccination|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
1333019|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels – Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Delivery||2019-12-31|12/2019||||
1333020|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels – Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Delivery||2019-12-31|12/2019||||
1333021|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels – Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific Ia GBS IgG antibody levels (anti-Ia) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Delivery|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
1333022|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||2019-12-31|12/2019||||
1333023|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||2019-12-31|12/2019||||
1333024|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels – Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
1333025|NCT02046148|Primary|Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||2019-12-31|12/2019||||
1333026|NCT02046148|Primary|Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)||2019-12-31|12/2019||||
1333042|NCT02045979|Secondary|AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira®|Area under the concentration time curve (AUC) from time zero to 1032 hours post dose (AUC 0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® PK is the abbreviation for Pharmacokinetic(s).|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333027|NCT02046148|Primary|Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
1333028|NCT02046148|Primary|Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for seortype III were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Birth, Day 42 and Day 90||2019-12-31|12/2019||||
1333029|NCT02046148|Primary|Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The data for serotype Ib were not available at the time of the posting (new assay currently in development and to be validated before the results release).|At Birth, Day 42 and Day 90||2019-12-31|12/2019||||
1333030|NCT02046148|Primary|Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Birth, Day 42 and Day 90|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
1333031|NCT02046122|Secondary|Rate of Hematopoietic Recovery|Hematopoietic recovery as measured by the date of the first of three consecutive laboratory values where the absolute neutrophil count (ANC) ≥ 500/μl , the date of the first of three consecutive laboratory values obtained on different days where the platelet count was > 20,000/μl without transfusion.|2 years after completion of therapy|||||||
1333032|NCT02046122|Secondary|Rate of Immune Recovery|Immune recovery determined by measurements of cytokine profiles, lymphocyte and natural killer (NK) enumeration and flow-based assays, measured prior to induction, prior to each round of consolidation, 8 weeks after the last cycle of consolidation, and every 3 months after treatment for up to 2 years|2 years after completing therapy|||||||
1333033|NCT02046122|Secondary|Rate of Efficacy|Efficacy as measured by the percentage of subjects with a complete remission.|2 years after completing therapy|||||||
1333034|NCT02046122|Secondary|Percentage of Subjects With Unacceptable Toxicity|Grade IV CTCAE toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting >7 days, Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days, or death|8 weeks after the last cell infusion||||percentage of participants|||Number
1333035|NCT02046122|Secondary|Percentage of Subjects With Acute GVHD|Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days|8 weeks after last cell infusion||||percentage of participants|||Number
1333036|NCT02046122|Secondary|Overall Survival|Overall survival 2 years after completing adoptive transfer therapy|2 years after completing therapy|||||||
1333037|NCT02046122|Secondary|Disease Free Survival|1 year disease free survival rate following adoptive transfer|one year following adoptive transfer|||||||
1333038|NCT02046122|Primary|Number of Subjects With Unacceptable Toxicity|"Unacceptable toxicity is defined as:~i. Grade III or IV acute GVHD (aGVHD) of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days;~ii. Grade IV Common Terminology Criteria for Adverse Events (CTCAE) toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting >7 days~iii. Treatment-related mortality (TRM)"|up to 8 weeks after last cell infusion||||Participants|||Count of Participants
1333039|NCT02046005|Primary|Contemplation Ladder|Measures willingness to change any of 4 RA-related behaviors compared to baseline using generalized estimating equations to compare the PRE-RA groups to the comparison arm.|Immediately, 6 weeks, and 6 months after intervention||||Participants|||Count of Participants
1333040|NCT02045979|Secondary|Number (Proportion) of Subjects With Drug Related Adverse Events|"All events with an onset after the first administration of the trial medication up to a period of 70 days after the last administration of the trial medication (i.e., end of the REP) was assigned to the treatment phase for evaluation and was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication.~All safety data were displayed and analyzed using descriptive statistical methods. No formal inferential analyses were planned for safety comparisons. Tabulations of frequencies and proportions, as appropriate were used for the evaluation of categorical (qualitative) data, and tabulations of descriptive statistics were used to analyze continuous (quantitative) data."|Day 1 through Day 71|The safety analysis set consisted of all subjects who received the single dose of trial medication (BI 695501, US-licensed Humira® or EU-approved Humira®).|||participants|||Number
1333043|NCT02045979|Secondary|AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 648 hours post dose (AUC 0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333044|NCT02045979|Secondary|AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 480 hours post dose (AUC 0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333045|NCT02045979|Secondary|AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 312 hours post dose (AUC 0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333046|NCT02045979|Secondary|AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 168 hours post dose (AUC 0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333047|NCT02045979|Primary|Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®|Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®.|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|The PK analysis set.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1333048|NCT02045979|Primary|Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®|Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333049|NCT02045979|Primary|Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®.~Abbreviation used: Pharmacokinetics (PK)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|PK analysis set consisted of all randomized subjects who received the single dose of trial medication (BI 695501, US-licensed - or EU-approved Humira®), had at least one evaluable primary PK endpoint and were without important protocol deviations or violations thought to significantly affect the PK of BI 695501, US-licensed - or EU-approved Humira®|||microgram (µg)*hour (h)/millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
1333050|NCT02045875|Secondary|Overall Adherence to Dulera 100/5 and 200/5|"Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark~Overall interval value was the mean of daily percent"|3 months|Data was only collected in the interventional group.|||percent of prescribed doses per day||Standard Deviation|Mean
1333051|NCT02045875|Secondary|Adherence to Dulera 100/5 and 200/5|"Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark~Adherence was calculated by taking the number of doses actually taken divided by the number of doses prescribed and multiplying by 100."|week 2. months 1, 2, and 3|Data was only collected in the interventional group.|||percent of prescribed doses||Standard Deviation|Mean
1333052|NCT02045875|Primary|Asthma Control|Asthma Control Questionnaire measured at each office visit. ACQ integrates values by 6 clinical questions related to symptoms and the value related to FEV1% predicted with a total score ranging from 0-6 and higher values indicating poorer asthma control.|Baseline, one, two and three months|All patients who completed ACQ at 4 clinical visits were included in the analysis|||units on a scale||Standard Deviation|Mean
1333053|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume|PVR volume was assessed by ultrasonography or a bladder scanner.|Baseline and Months 1, 3, 6, 9, 12|SAF population with data available at each time point. LOCF was used for EoT.|||mL||Standard Deviation|Mean
1333054|NCT02045862|Secondary|Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT|The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333064|NCT02045862|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333296|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.|24 hours|Count reported for nausea/vomiting.|||Participants|||Count of Participants
1333055|NCT02045862|Secondary|Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT|The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333056|NCT02045862|Secondary|Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333057|NCT02045862|Secondary|Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333058|NCT02045862|Secondary|Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333059|NCT02045862|Secondary|Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT|The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333060|NCT02045862|Secondary|Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT|The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333061|NCT02045862|Secondary|Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT|The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.|Baseline and Months 1, 3, 6, 9, 12|FAS with data available at each time point. Participants with less < 8 micturitions per 24 hours at baseline were not included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1333062|NCT02045862|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333063|NCT02045862|Secondary|Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333065|NCT02045862|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333066|NCT02045862|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
1333067|NCT02045862|Secondary|Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6, 12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values during the study are included in the analysis. LOCF was used for EoT.|||percentage of activity Impairment||Standard Deviation|Mean
1333068|NCT02045862|Secondary|Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6, 12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.|||percentage of overall work impairment||Standard Deviation|Mean
1333069|NCT02045862|Secondary|Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6, 12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.|||percentage of impairment while working||Standard Deviation|Mean
1333070|NCT02045862|Secondary|Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6,12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.|||percentage of work time missed||Standard Deviation|Mean
1333071|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
1333072|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
1333073|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
1333196|NCT02045264|Primary|Peak Plasma Concentration (Cmax) of Icatibant and Metabolites|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
1333074|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS populaton; LOCF was used for EoT.|||Participants|||Count of Participants
1333075|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and 12 Months|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
1333076|NCT02045862|Secondary|Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT|The PGIC is a 2-part questionnaire, assessing both the change in the patient’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Month 12|FAS population with data available. LOCF was used for EoT.|||percentage of participants|||Number
1333077|NCT02045862|Secondary|Percentage of Participants in Each Category of Patient’s Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT|The PGIC is a 2-part questionnaire, assessing both the change in the patient’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Month 12|FAS population with data available. LOCF was used for EoT.|||percentage of participants|||Number
1333078|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)|The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1333079|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS|The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1333080|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1333081|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1333082|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1333083|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1333084|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1334059|NCT02029521|Primary|Fecal Calprotectin|Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.|6 months|All participants.|||Micrograms/gram feces||Standard Deviation|Mean
1333085|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score|The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1333086|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit|The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF was used for EoT.|||pads||Standard Error|Least Squares Mean
1333087|NCT02045862|Secondary|Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit|The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF was used for EoT.|||pads||Standard Error|Mean
1333088|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours|The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 pads used at baseline were included in the analysis. LOCF was used for EoT.|||pads||Standard Error|Least Squares Mean
1333089|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.|||nocturia episodes||Standard Error|Least Squares Mean
1333090|NCT02045862|Secondary|Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit|A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.|||nocturia episodes||Standard Error|Mean
1333091|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours|"A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.|||nocturia episodes||Standard Error|Least Squares Mean
1333092|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Participants with ≥ 1 urgency episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency episodes||Standard Error|Least Squares Mean
1333093|NCT02045862|Secondary|Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition|The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit.|Baseline and Months 3, 6, 12|FAS population with data available at each time point.|||mL||Standard Error|Least Squares Mean
1333094|NCT02045862|Secondary|Change From Baseline to EoT in Corrected Micturition Frequency|Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.|Baseline and Month 12|FAS population; LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
1333095|NCT02045862|Secondary|Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)|The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||days||Standard Error|Mean
1333197|NCT02045238|Secondary|Incidence of Adverse Effects|Any adverse effects directly attributable to treatment shall be noted. Mere lack of improve or worsening of symptoms attributable to the disease clinical course will not be considered as adverse effects.|24 hours|Number of patients too small to achieve statistical significance|||participants|||Number
1333096|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||micturitions||Standard Error|Least Squares Mean
1333097|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1333098|NCT02045862|Secondary|Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Mean
1333099|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1333100|NCT02045862|Secondary|Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit|The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||days||Standard Error|Mean
1333101|NCT02045862|Secondary|Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit|The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.|Months 1, 3, 6, 9, 12|FAS population with with data available at each time point; LOCF was used for EoT.|||incontinence-free days||Standard Error|Mean
1333102|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
1333103|NCT02045862|Secondary|Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||incontinence episodes||Standard Error|Mean
1333104|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||incontinence episodes||Standard Error|Least Squares Mean
1333105|NCT02045862|Secondary|Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)|The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and Week 52|FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1333106|NCT02045862|Secondary|Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Week 52|FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1333107|NCT02045862|Secondary|Change From Baseline to EoT in Mean Volume Voided Per Micturition|The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.|Baseline and Week 52|FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.|||mL||Standard Error|Least Squares Mean
1333108|NCT02045862|Primary|Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.|Baseline and Week 52|FAS population; LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
1333109|NCT02045862|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.|Baseline and Week 52|FAS population; Last observation carried forward (LOCF) was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
1333110|NCT02045862|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).|From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)|The analysis population was the safety analysis set (SAF), which consisted of all participants who received ≥ 1 dose of double-blind study drug and excluded participants from one site due to protocol noncompliance.|||Participants|||Count of Participants
1333111|NCT02045836|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the period starting after 30 days post last vaccination up to study end (Month 3 – Month 14 for the Co-Ad Group &amp; Month 5 – Month 16 for the Control Group)|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
1333112|NCT02045836|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to 30 days post last vaccination (Month 0 – Month 3 for the Co-Ad Group &amp; Month 0 – Month 5 for the Control Group)|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
1333113|NCT02045836|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the first dose up to 30 days post last vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
1333114|NCT02045836|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|From the first dose up to 30 days post last vaccination period||||Participants|||Count of Participants
1333115|NCT02045836|Secondary|Number of Days With Any Solicited Local and General Symptoms|The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0.|Within 7 days (Days 0 - 6) after each vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||days||Inter-Quartile Range|Median
1333116|NCT02045836|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|This analysis was performed on the Total Vaccinated cohort, including subjects with at least one vaccine dose administered, only on those subjects with completed symptom sheets.|||Participants|||Count of Participants
1333117|NCT02045836|Secondary|Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Days 0 - 6) after vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
1333118|NCT02045836|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.|Within 7 days (Days 0 - 6) after each vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
1333198|NCT02045238|Secondary|Rate of Readmission After Discharge|The mere attendance to the Emergency Department will not be isolately considered, as it may be due to a scheduled reevaluation.|5 days|||||||
1333199|NCT02045238|Secondary|Time to Discharge|Actual time to discharge was considered of secondary importance as it can be influenced by individual considerations like patient age or time of the day.|24 hours|||||||
1333119|NCT02045836|Primary|Adjusted GMCs Between Groups|The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations|At 1 month after last vaccine dose|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1333120|NCT02045836|Primary|Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups|The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).|At 1 month after vaccination|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1333121|NCT02045836|Primary|Anti-pneumococcal Antibody Titers|Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.|At one month post-dose (Month 1)|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1333122|NCT02045836|Primary|Anti-glicoprotein E (gE) Antibody Concentrations|Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).|At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1333123|NCT02045836|Primary|Number of Subjects With a Vaccine Response for Anti-gE Antibodies|"Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as :~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration"|At Month 3|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
1333124|NCT02045797|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Samples for urinalysis assessment was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for Glucose, Ketones, Occult Blood, Protein and pH. Participants with abnormal urinalysis result was reported.|Up to day 28|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1333125|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Hematocrit|Blood samples for assessment of hematology parameter of hematocrit was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Ratio||Standard Deviation|Mean
1333126|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocytes|Blood samples for assessment of hematology parameter of erythrocyte was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Trillion cells per liter||Standard Deviation|Mean
1333127|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)|Blood samples for assessment of hematology parameter of EMCV was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Femtoliter||Standard Deviation|Mean
1333128|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)|Blood samples for assessment of hematology parameter of EMCH was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Picograms||Standard Deviation|Mean
1333139|NCT02045797|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Breaths per minute||Standard Deviation|Mean
1333129|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin|Blood samples for assessment of hematology parameters of EMCHC and hemoglobin was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Gram per liter||Standard Deviation|Mean
1333130|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets|Blood samples for assessment of hematology parameters of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Giga cells per liter||Standard Deviation|Mean
1333131|NCT02045797|Secondary|Estradiol Values at Baseline|Blood samples for assessment of clinical chemistry parameter of estradiol was collected at Baseline (Day 1). No post-baseline values were reported.|Baseline (Day 1)|Safety Population. Only those participants available at the indicated time points were analyzed.|||Picomole per liter||Standard Deviation|Mean
1333132|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated|Blood samples for assessment of clinical chemistry parameter of estimated creatinine clearance was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Milliliter per minute||Standard Deviation|Mean
1333133|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea|Blood samples for assessment of clinical chemistry parameters of calcium, carbon dioxide, chloride, glucose, magnesium, potassium, sodium and urea was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Millimole per liter||Standard Deviation|Mean
1333134|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate|Blood samples for assessment of clinical chemistry parameters of bilirubin, creatinine, direct bilirubin and urate was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Micromoles per liter||Standard Deviation|Mean
1333135|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein|Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Gram per liter||Standard Deviation|Mean
1333136|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)|Blood samples for assessment of clinical chemistry parameters of ALT, ALP, AST, FSH and GGT was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||International units per liter||Standard Deviation|Mean
1333137|NCT02045797|Secondary|Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings|The 12-lead ECGs was obtained at Day 1, Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for corrected QT, using Fridericia formula (QTcF), corrected QT using Bazett’s formula (QTcB) and QRS intervals. The number of participants with maximum post-baseline ECG value exceeding the following limits have been reported: QTcB/QTcF interval > 450 and ≤ 480 millisecond (msec), QTcB/QTcF interval > 480 and ≤ 500 msec, QTcB/QTcF interval > 500 msec, QRS interval < 70 msec and QRS interval > 120 msec.|Up to Day 28|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1333138|NCT02045797|Secondary|Change From Baseline in Vital Sign: Body Temperature|Body temperature was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Celcius||Standard Deviation|Mean
1340184|NCT01940484|Primary|Mean Hemoglobin Value at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
1333140|NCT02045797|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Beats per minute||Standard Deviation|Mean
1333141|NCT02045797|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Millimeters of mercury||Standard Deviation|Mean
1333142|NCT02045797|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or all events of possible drug-induced liver injury with hyperbilirubinemia.|Up to Day 28|Safety population comprised the same set of participants from MITT population and received at least one dose of study medication.|||Participants|||Count of Participants
1333143|NCT02045797|Secondary|Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens|Reduction in susceptibility was defined as a >=4-fold increase in minimum inhibitory concentration (MIC) or >=6 millimeter decrease in zone size between an isolate obtained at Baseline and the same pathogen at subsequent visits.|Up to Day 28|Modified MITT Population.|||Participants|||Count of Participants
1333144|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy|Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1333145|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy|Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1333146|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy|Samples for assessment of PK parameter tmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
1333147|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy|Samples for assessment of PK parameter tmax was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
1333148|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy|Samples for assessment of PK parameter Cmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1333149|NCT02045797|Secondary|Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy|Samples for assessment of PK parameter Cmax was done on at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population consisted of all participants in the PK concentration population for whom valid and evaluable PK parameters were derived. Only those participants available at the indicated time points were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1333189|NCT02045264|Secondary|Safety Evaluation Measured by Percentage of Subjects With Not Clinically Significant Abnormalities in ECG Results||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||percentage of participants|||Number
1333150|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|Microbiological outcome was determined by comparing Baseline blood culture, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA, MRSA and all Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333151|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for all Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333152|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for other Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333153|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333154|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333155|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT.|||Number of pathogens|||Number
1333190|NCT02045264|Secondary|The Percentage of Subjects With Any Injection Site Reactions.||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||percentage of participants|||Number
1333191|NCT02045264|Secondary|The Total Number of Treatment-Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were those that started after the single dose of icatibant.|TEAEs were collected after the single dose of icatibant until follow up, 5-7 days after icatibant administration|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||Treatment Emergent Adverse Events|||Number
1333156|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333157|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333158|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333159|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333160|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333161|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained at post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333192|NCT02045264|Primary|Total Body Clearance (CL/F) of Icatibant|The rate at which a drug is removed from the body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||mL/hr||Standard Deviation|Mean
1333162|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|The microbiological outcome was determined by comparing Baseline bacteriology blood culture, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA, MRSA and all Gram-positive aerobic pathogens in blood sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333163|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for all Gram-positive aerobic pathogens in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333164|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for other Gram-positive aerobic pathogens in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333165|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MSSA in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333166|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MRSA in lesion sample has been presented.|Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
1333167|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT consisted of all randomized participants who received at least one dose of study medication and had a Gram-positive pathogens identified from their Baseline bacteriology lesion sample.|||Number of pathogens|||Number
1333193|NCT02045264|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Icatibant and Metabolites|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
1333168|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as no increase in the total surface area of the lesion (as calculated by digital imaging) compared to post therapy visit and no further administration of antibacterial therapy for the lesion under study. Clinical recurrence was defined as death of participant; increase in the area of the lesion compared to post therapy visit or administration of additional antibacterial therapy for the lesion under study before the efficacy endpoint assessment for participants who were a clinical success at post therapy visit. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Day 21 to Day 28|MITT population.|||Participants|||Count of Participants
1333169|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Day 12 to Day 18|MITT population.|||Participants|||Count of Participants
1333170|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at Early Efficacy Visit|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Up to Day 3|MITT population.|||Participants|||Count of Participants
1333171|NCT02045797|Primary|Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate|Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.|Up to Day 3|Modified Intent-to-Treat (MITT) population consisted of all randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
1333172|NCT02045732|Secondary|Concentration of PF-06342674||Baseline through Day 127/Early Termination|Participants in the placebo arm did not receive PF-06342674. Due to the early termination of the study, the small enrollment number and minimal data, concentration data were listed but not summarized, and pharmacokinetic (PK) parameters were not calculated for the PF-06342674 0.25 mg/kg arm.|||nanogram/milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
1333173|NCT02045732|Primary|Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)|Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32.|Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
1333174|NCT02045732|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug. The QTcF interval of the participant in the placebo arm was in this range of 450 to <480 msec at Baseline. This participant experienced a decrease in QTcF of 30 to <60 msec on Day 30, which then returned to baseline levels on Day 57.|||participants|||Number
1333175|NCT02045732|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
1333194|NCT02045264|Primary|Drug Concentration Half-Life (T1/2) of Icatibant and Metabolites|The time it takes for the blood plasma concentration of a substance to halve.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||hr||Standard Deviation|Mean
1333200|NCT02045238|Primary|Time to Attain Discharge Criteria|Discharge criteria are: Room air saturation >94% AND respiratory rate < 60 AND Respiratory Distress Assessment Instrument (RDAI) score inferior than 4, maintained over a 4 hour period.|24 hours|||||||
1333176|NCT02045732|Primary|Number of Participants With Clinical Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
1333177|NCT02045732|Primary|Number of Treatment-Emergent AEs and SAEs by Severity|AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||adverse events|||Number
1333178|NCT02045732|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
1333179|NCT02045511|Secondary|Change From Baseline in SF-36 Physical Component at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~Measure collected via one-on-one interview conducted by trained data collectors.~Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.~Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = [4-71]."|3 months||||units on a scale||Standard Deviation|Mean
1333180|NCT02045511|Secondary|Change From Baseline in SF-36 Mental Component at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~Data were collected via one-on-one interviews with trained data collectors.~Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.~Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = [2-74]."|3 months||||units on a scale||Standard Deviation|Mean
1333181|NCT02045511|Secondary|Change From Baseline in PHQ-9 at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~[1] Measure Description: Measure collected via one-on-one interview conducted by trained data collectors.~Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27.~Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression.~Change from baseline to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity."|3 months||||units on a scale||Standard Deviation|Mean
1333182|NCT02045511|Secondary|Change From Baseline in Revised UCLA at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~[1] Measure Description: Measure was collected via a one-on-one interview conducted by a trained data collector.~20-item Likert-type scale. Total score is sum of the 20 items, scores range from 20 to 80. Lower values equate to lower levels of loneliness and higher values equate to higher levels of loneliness.~Perry et al., 1990 uses the following score ranges:~20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness"|3 months||||units on a scale||Standard Deviation|Mean
1333183|NCT02045511|Secondary|Change From Baseline in Revised QDS at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~[1] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector.~Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5)~Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best)~Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference."|3 months||||units on a scale||Standard Deviation|Mean
1333184|NCT02045511|Primary|Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~Measure Description: Measure was collected through a one-on-one interview with a trained data collector.~Scoring:~0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap"|3 months||||units on a scale||Standard Deviation|Mean
1333185|NCT02045264|Secondary|Change From Baseline in Pulse Rate||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||beats per minute||Standard Deviation|Mean
1333186|NCT02045264|Secondary|Change From Baseline in Systolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||mmHg||Standard Deviation|Mean
1333187|NCT02045264|Secondary|Change From Baseline in Diastolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||mmHg||Standard Deviation|Mean
1333188|NCT02045264|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Icatibant and Metabolites|AUC0-t is the area under the plasma concentration versus time curve extrapolated from time 0 to to the last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
1333203|NCT02045108|Primary|Alcohol Approach Bias|For each participant, bias is computed by taking the median response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick. Group means of these medians are presented as the outcome measure.|1 week after treatment|Three participants in the Sham TDCS/Active Retraining, one participant in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||milliseconds||Standard Deviation|Mean
1333204|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|8 weeks post-baseline|Two participants in the Active TDCS/Active Retraining, four participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and three participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
1333205|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|5 weeks post-baseline|One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
1333206|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|4 weeks post-baseline|One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
1333207|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|3 weeks post-baseline|Two participant in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
1333208|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|2 weeks post-baseline|Two participants in the Active TDCS/Sham retraining and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
1333209|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|1 week post-baseline||||standard drinks per drinking day||Standard Deviation|Mean
1333210|NCT02045108|Primary|Alcohol Approach Bias|For each participant, bias is computed by taking the median response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick. Group means of these medians are presented as the outcome measure.|Baseline||||milliseconds||Standard Deviation|Mean
1333211|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day of the prior 30 days. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|Screening Visit|At-risk alcohol drinkers ages 21-30|||drinks per drinking day||Standard Deviation|Mean
1333212|NCT02044991|Secondary|Disability|Disability is measured at baseline (0 weeks) and week 8 using the Oswestry Disability Index (ODI), which is a measure of low back pain that ranges from 0 points to 100 with higher scores indicating greater disability. The change in disability between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.|||change score on the ODI scale||Full Range|Median
1333213|NCT02044991|Secondary|Pelvic Functioning|Pelvic functioning is measured at baseline (0 weeks) and week 8 using the Pelvic Girdle Questionnaire (PGQ), which ranges from 0 to 100 points with higher scores revealing greater pelvic girdle pain. The change in pelvic functioning between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.|||change score on the PGQ scale||Full Range|Median
1333214|NCT02044991|Primary|Change in Pain|Pain is measured using the Pain Numeric Rating Scale (NRS), which ranges from 0 to 10 with higher scores indicating greater pain. This measure is recorded at baseline (0 weeks) and 8 weeks. The change in pain between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.|||change score on the NRS pain scale||Full Range|Median
1333215|NCT02044848|Primary|Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test|Study was terminated and no data were collected for the Outcome Measure.|Week 52|Study was terminated and no data were collected for the Outcome Measure||||||
1333297|NCT02043704|Primary|Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery|Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.|24 hours||||mgs||Inter-Quartile Range|Median
1333216|NCT02044822|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1333217|NCT02044822|Secondary|Overall Survival|Overall survival was defined as the interval from the start of study treatment to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
1333218|NCT02044822|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1333219|NCT02044822|Secondary|Complete Response Rate|Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1333220|NCT02044822|Secondary|Nodal Response Rate|Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1333221|NCT02044822|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1333222|NCT02044822|Primary|Overall Response Rate|Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1333223|NCT02044458|Other Pre-specified|Failure Rates of the Placement of a Foley Catheter|To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette|Followed throughout patient's hospital stay, approximately 10 days||||failed attempt|||Number
1333224|NCT02044458|Secondary|Pain Assessed by Visual Analog Scale (VAS)|To compare the pain assessed by visual analogue scale(VAS), in women randomly allocated to ridged stylette or no ridged stylette. Patient-assessed pain level was determined by verbally asking patients to assess their pain (on a scale from 0-10 [no pain-worst pain]) following taping of the catheter tail. Pain was only assessed once.|Followed throughout patient's hospital stay, approximately 10 days|The pain level of one successful attempt with stylette was not recorded.|||units on a scale||95% Confidence Interval|Mean
1333225|NCT02044458|Primary|Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.|Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).|Followed throughout patient's hospital stay, approximately 10 days|The insertion time of two failed attempts with no stylette were not recorded.|||minutes||Inter-Quartile Range|Median
1333226|NCT02044419|Primary|λz|Elimination rate constant estimated from individual linear regression of the terminal part of the log concentration vs time curve of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||1/h||Standard Deviation|Mean
1333227|NCT02044419|Primary|AUC0-∞|Area under the plasma concentration vs time curve from zero to infinity of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||ng*h/mL||Standard Deviation|Mean
1333228|NCT02044419|Primary|t1/2|Terminal elimination half-life of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||h||Standard Deviation|Mean
1333229|NCT02044419|Primary|Tmax|Time to reach maximum plasma concentration of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||hours||Full Range|Median
1333230|NCT02044419|Primary|Cmax|Maximum observed concentration of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||ng/mL||Standard Deviation|Mean
1333298|NCT02043704|Primary|Pain While Active - 18 hr|Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.|18 hours||||mm||Inter-Quartile Range|Median
1333231|NCT02044419|Primary|AUC0-t|Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||ng*h/mL||Standard Deviation|Mean
1333232|NCT02044393|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)|AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity).|from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1333233|NCT02044393|Primary|Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)|Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).|From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1333234|NCT02044393|Primary|AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)|AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.|from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|Pharmacokinetic Set (PKS): included all subjects from the TS who provided at least one primary or secondary pharmacokinetic endpoint in any period that is judged as evaluable for pharmacokinetics and is not affected by protocol violations relevant to the statistical evaluation of bioavailability|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1333235|NCT02044380|Primary|Safety Assesment|"Safety was assessed by:~All serious adverse events (SAEs)~All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib~Non-serious AEs assessed by the treating physician as related to afatinib."|From first administration of treatment until 28 days after last drug administration, up to 80 weeks.|Treated set|||Percentage of participants|||Number
1333236|NCT02044367|Secondary|Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Palatability question: How do you rank the taste? with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.|||participants|||Number
1333237|NCT02044367|Secondary|Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Acceptability question: Would you accept to take this medication for chronic use? with 3 possible answers: Yes - No - I am not sure."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.|||participants|||Number
1333238|NCT02044367|Secondary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333239|NCT02044367|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333240|NCT02044367|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333241|NCT02044367|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
1333242|NCT02044302|Secondary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation One Month|The study was terminated after 2 subjects enrolled and outcomes were never summarized.||||||
1333243|NCT02044302|Secondary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation Week 1|The study was terminated after 2 subjects enrolled and outcomes were never summarized.||||||
1333244|NCT02044302|Primary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain you had. The other numbers mean that pain is in perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation Day 1|The study was terminated after 2 subjects enrolled and outcomes were never fully collected not summarized.||||||
1333245|NCT02044094|Secondary|"Change From Placebo in VAS Score for Do You Feel Sedated? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333246|NCT02044094|Secondary|"VAS Score for Do You Feel Sedated? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333247|NCT02044094|Secondary|"Change From Placebo in VAS Score for Does the Drug Have Any Bad Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333248|NCT02044094|Secondary|"VAS Score for Does the Drug Have Any Bad Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333249|NCT02044094|Secondary|"Change From Placebo in VAS Score for Does the Drug Have Any Good Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333270|NCT02043808|Secondary|Deep Vein Thrombosis|"Event rate of deep vein thrombosis.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333299|NCT02043652|Secondary|Number of Patients Reporting Relapses|Evaluate the relapse rate, that is reappearance of parasites, for up to 6 months after treatment.|6 months||||Participants|||Count of Participants
1333250|NCT02044094|Secondary|"VAS Score for Does the Drug Have Any Good Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333251|NCT02044094|Secondary|"Change From Placebo in VAS Score for Do You Feel Any Drug Effect? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333252|NCT02044094|Secondary|"VAS Score for Do You Feel Any Drug Effect? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333253|NCT02044094|Secondary|"Change From Placebo in VAS Score for How High Are You Right Now? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy 6 mg / 18 mg"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333254|NCT02044094|Secondary|"VAS Score for How High Are You Right Now? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333255|NCT02044094|Secondary|"Change From Placebo in VAS Score for Do You Like the Drug? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333271|NCT02043808|Secondary|Venous Thromboembolism|"Event rate of venous thromboembolism.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1340468|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1333256|NCT02044094|Secondary|"Visual Analog Scale (VAS) Score for Do You Like the Drug? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333257|NCT02044094|Secondary|Change From Placebo in Reinforcing Effects (Breakpoint) by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)|"This endpoint explores the correlation between the reinforcing effects of hydromorphone and simulated mu opioid receptor occupancy.~Data are reported as change from placebo least square mean of Log10 transformed values for reinforcing effects. Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||log10 transformed ratio||95% Confidence Interval|Least Squares Mean
1333258|NCT02044094|Secondary|Predicted mu Opioid Receptor Occupancy (μORO) by Mean Buprenorphine Concentrations and Study Week|"A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed to model the relationship between buprenorphine plasma concentrations and brain μORO based on 2 published clinical trials. This model used individual buprenorphine plasma concentrations measured to derive muORO individual predictions that were further described using summary statistics. The relationship between buprenorphine plasma concentration and μORO was best described by a maximal effect (Emax) model:~µORO = E(max)*Cp / EC(50) + Cp~Where Cp is the plasma concentration of buprenorphine, Emax is the maximal μORO, and EC50 is the plasma concentration of buprenorphine that is expected to achieve 50% of the maximal μORO. A direct (instantaneous) relationship between buprenorphine plasma concentration and µORO, i.e. without equilibration delay, was assumed.~Row title format: Study Week: buprenorphine plasma concentrations for placebo/ 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population|||percentage receptor occupancy||Standard Deviation|Mean
1333259|NCT02044094|Secondary|Plasma Concentrations of Buprenorphine Summarized by Study Week|"PK Sampling Schedule:~Day -17 to -15: before hydromorphone admin~Day -4: before Suboxone admin~Day 2: 24 hours after RBP-6000 admin~Days 5-7, 12-14, 19-21 and 26-28: immediately before hydromorphone admin~Days 29: before RBP-6000 admin~Day 30: 24 hours after RBP-6000 admin~Days 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, and 82-84: immediately before hydromorphone admin"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT|||ng/mL||Standard Deviation|Mean
1333260|NCT02044094|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"TEAE=any untoward medical occurrence that develops or worsens in severity after administration of study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required intervention to prevent one of the outcomes listed above.~All adverse events that occurred between Day 1 to Day 91 are reported under the Depot Buprenorphine treatment arm.~Adverse events that occurred on the day of a hydromorphone challenge are also reported under the appropriate hydromorphone challenge arm."|Depot Buprenorphine: Day 1 to Day 91. The three hydromorphone challenge levels were randomly assigned to one day in each of the three-day groupings spanning 12 weeks: Days 5-7, 11-14, 19-21, 26-28, 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, 82-84|Safety; one participant was administered the first RBP-6000 injection but no hydromorphone challenges. Investigators did not assess AEs for potential relatedness to hydromorphone.|||Participants|||Count of Participants
1333261|NCT02044094|Secondary|Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value at Weeks 1-12|"The ability of RBP-6000 to reduce the reinforcing effects of hydromorphone used money as a choice alternative to hydromorphone.~Reinforcing Effects Tasks began no earlier than 5 hours after randomised hydromorphone administration for each day. Each test consisted of the participant making 12 choices between a preference for working for the amount of hydromorphone dosed earlier that day or for money (each choice therefore has a scale of 0-12). The hydromorphone break point value is the ratio of the highest number of choices for hydromorphone to the highest number of choices for money. Hydromorphone breakpoint values were then analysed by week using a repeated measures mixed-effects model with period, hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect. Analyses were carried out on the log10 transformed hydromorphone breakpoint value."|Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28), 5 (Days 33-35), 6 (Days 40-42), 7 (Days 47-49), 8 (Days 53-56), 9 (Days 61-63), 10 (Days 68-70), 11 (Days 75-77), 12 (Days 82-84)|Intent to treat population|||log10 transformed ratio||Standard Error|Least Squares Mean
1333272|NCT02043808|Secondary|Myocardial Infarction|"Event rate of myocardial infarction.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333300|NCT02043652|Primary|Number of Patients With Adequate Clearance of Parasites and Symptoms|Investigators, according to WHO guidelines, will evaluate patients at regular intervals to evaluate symptom and parasitemia clearance.|28 days||||Participants|||Count of Participants
1333262|NCT02044094|Secondary|Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~A repeated measures mixed-effects analysis of variance (ANOVA) was performed with the log transformed hydromorphone break point value as the dependent variable with period, hydromorphone sequence and hydromorphone dose as fixed effects, and subject nested within hydromorphone sequence as a random effect.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1333263|NCT02044094|Primary|"Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question Do You Like the Drug? Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures"|"The study's primary objective was to determine if the opioid blocking effect for the first injection of buprenorphine 300 mg (RBP-6000) on Day 1 was not inferior to placebo when challenged by hydromorphone.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone administration on the challenge days listed in the time frame field. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis."|Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28)|The intent-to-treat (ITT) population included all subjects who received at least 1 dose of RBP-6000 and had at least 1 complete sequence (i.e., 0 mg [placebo], 6 mg and 18 mg hydromorphone in the randomised order) of hydromorphone challenges following administration of RBP-6000.|||units on a scale||Standard Error|Least Squares Mean
1333264|NCT02043938|Other Pre-specified|Propofol, Sevoflurane, and Remifentanil Interaction.|For all study groups (i.e. P, S, PR, and SR), the estimated PD model parameters that represent remifentanil interactions are Theta1 and Theta2, which are unit-less values. Theta1 and Theta2 are zero for all volunteers not receiving remifentanil. In case an interaction between remifentanil and propofol or sevoflurane exists, the estimate for Theta1 will be significantly different from zero. If the interaction in the 4 ng/mL group exceeds the estimated interaction for the 2 ng/mL group, Theta2 will be significantly higher than zero.|6 weeks|18 participants experienced the remifentanil 2 ng/mL intervention, and 18 participants experienced the remifentanil 4 ng/mL intervention.|||Index||Standard Error|Mean
1333265|NCT02043938|Other Pre-specified|Patient State Index (PSI) Comparison, C50 (Propofol, Propofol+Remifentanil)|Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50).|6 weeks|All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR).|||ug/mL||Standard Error|Mean
1333266|NCT02043938|Other Pre-specified|Patient State Index (PSI) Comparison, C50 (Sevoflurane, Sevoflurane+Remifentanil)|Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50).|6 weeks|All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR).|||%vol||Standard Error|Mean
1333267|NCT02043938|Primary|Patient State Index (PSI) Comparison, Baseline and Emax|Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50).|6 weeks|All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR).|||index||Standard Error|Mean
1333268|NCT02043808|Secondary|Death|"Event rate of death, due to any cause.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333269|NCT02043808|Secondary|Pulmonary Embolism|"Event rate of pulmonary embolism.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333273|NCT02043808|Secondary|Transient Ischemic Attack|"Event rate of transient ischemic attacks.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333274|NCT02043808|Secondary|Major Other Bleeding|"Event rate of major other bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333275|NCT02043808|Secondary|Major Urogenital Bleeding|"Event rate of major urogenital bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333276|NCT02043808|Secondary|Major Lower GI Bleeding|"Event rate of major lower gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333277|NCT02043808|Secondary|Major Upper GI Bleeding|"Event rate of major upper gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333278|NCT02043808|Secondary|Major GI Bleeding|"Event rate of major gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333279|NCT02043808|Secondary|Major Extracranial Bleeding|"Event rate of major extracranial bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333280|NCT02043808|Secondary|Major Intracranial Bleeding|"Event rate of major intracranial bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333281|NCT02043808|Secondary|Hemorrhagic Stroke|"Event rate of hemorrhagic stroke.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333282|NCT02043808|Secondary|Ischemic Stroke|"Event rate of ischemic stroke.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333283|NCT02043808|Primary|Major Bleeding|"Event rate of major bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333284|NCT02043808|Primary|Stroke (Hemorrhagic, Ischemic)|"Event rate of stroke (hemorrhagic, ischemic).~Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65–74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
1333285|NCT02043782|Primary|Degree of Leakage|The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.|14 +/- 3 days||||units on a scale|Participants|Standard Deviation|Mean
1333286|NCT02043704|Other Pre-specified|Time to First Flatus/Bowel Movement|Length of time from the end of surgery to the time of first flatus or bowel movement.|9000 minutes||||minutes||Inter-Quartile Range|Median
1333287|NCT02043704|Secondary|Time to Ambulation|Length of time from the end of surgery to the time of ambulation.|1800 minutes||||minutes||Inter-Quartile Range|Median
1333288|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for urinary retention.|24 hours||||Participants|||Count of Participants
1333289|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for respiratory depression.|24 hours||||Participants|||Count of Participants
1333290|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for shortness of breath.|24 hours||||Participants|||Count of Participants
1333303|NCT02043379|Secondary|Immunoglobulin Concentration in Peritoneal Dialysis Drainage|Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative.|24 hours post-op||||mg/dL||Inter-Quartile Range|Median
1333304|NCT02043379|Secondary|Tumor Necrosis Factor Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/dL||Inter-Quartile Range|Median
1333305|NCT02043379|Secondary|Interleukin-8 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/dL||Inter-Quartile Range|Median
1333306|NCT02043379|Secondary|Interleukin-6 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
1333307|NCT02043379|Secondary|Interleukin-1b Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
1333308|NCT02043379|Secondary|Interleukin-12p70 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
1333309|NCT02043379|Secondary|Interleukin-10 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
1333310|NCT02043379|Secondary|Respiratory Variables|Total time duration of post-operative length of mechanical ventilation until hospital discharge|until extubation, an average of 2 days||||hours||Inter-Quartile Range|Median
1333311|NCT02043379|Secondary|Respiratory Variables|Time until first extubation in hours|until extubation, an average of 2 days||||hours||Inter-Quartile Range|Median
1333312|NCT02043379|Secondary|Fluid Overload Variables|The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.|0-48 hours post-CPB||||militers/kilogram||Inter-Quartile Range|Median
1333313|NCT02043379|Secondary|Intensive Care Unit Length of Stay|The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0.|1 month||||hours||Inter-Quartile Range|Median
1333314|NCT02043379|Secondary|Mortality|Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge .|Approximately 1 month||||subjects|||Number
1333315|NCT02043379|Secondary|Immunoglobulin Concentration in Chest Tube Drainage|Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative.|24 hours post-op||||mg/dL||Inter-Quartile Range|Median
1333316|NCT02043379|Secondary|Interferon-gamma Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|Pre-operative to 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
1333317|NCT02043379|Secondary|Plasma Immunoglobulins|Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op|5 days post-op||||mg/dL||Standard Deviation|Mean
1333318|NCT02043379|Secondary|Hospital Discharge|From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days.|Approximately 1 month||||days||Inter-Quartile Range|Median
1333319|NCT02043379|Secondary|Respiratory Variables|Alive, ventilator free days will be recorded at hospital discharge.|until Hospital Discharge, an average of 30 days||||days||Inter-Quartile Range|Median
1333320|NCT02043379|Secondary|Post-operative Inotrope Score|"The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a normal scale or range used for this calculation."|first 48 hours post-CPB||||inotropic score||Inter-Quartile Range|Median
1333321|NCT02043379|Secondary|Fluid Overload Variables|The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.|0-24 hours post-CPB||||mililiters/kilogram||Inter-Quartile Range|Median
1333322|NCT02043379|Secondary|Post-operative Plasma Albumin|Plasma albumin will be assessed at 24 and 48 hours.|up to 48 hours post CPB||||g/dL||Standard Deviation|Mean
1333323|NCT02043379|Primary|Blood Stream Infection Within 1 Week of Surgery||7 days||||subjects|||Number
1333324|NCT02043379|Primary|Blood Stream Infection|Any positive blood culture during the post-operative period until hospital discharge|until Hospital Discharge, an average of 30 days||||subjects|||Number
1333325|NCT02043379|Primary|Post-operative Infection|Any positive culture or treatment for culture negative sepsis within 1 week of surgery|within 1 week of surgery||||Subjects|||Number
1333326|NCT02043379|Primary|Post-Operative Infections|The primary endpoint of this study is incidence of post-operative infections through hospital discharge|until Hospital Discharge, an average of 30 days||||subjects|||Number
1333993|NCT02030535|Secondary|QT Change From Patient Baseline at Individual Post-dose Time Points|QT change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333327|NCT02043366|Secondary|Normalized Area of Hyperalgesia Around the Incision|The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a ‘painful’, ‘sore’ or ‘sharper’ feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.|24 hours after surgery||||cm^2||Standard Deviation|Mean
1333328|NCT02043366|Secondary|Cumulative Sufentanyl Consumption|Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively|24 hours|||||||
1333329|NCT02043366|Secondary|Total Dose of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour after surgery|||||||
1333330|NCT02043366|Secondary|Occurrence of Side Effects|Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus|24 hours|||||||
1333331|NCT02043366|Secondary|Time of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour post surgery|||||||
1333332|NCT02043366|Secondary|Pain Score (NRS)|The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.|3h, 6h, 12h, and 24h after surgery|||||||
1333333|NCT02043366|Primary|Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm|The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively|24 hours after surgery||||g||Standard Deviation|Mean
1333334|NCT02043145|Primary|Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale|The Investigator assessed the severity of the patient’s glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.|||score on a scale||Standard Deviation|Mean
1333335|NCT02043145|Primary|Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale|The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.|||score on a scale||Standard Deviation|Mean
1333336|NCT02043145|Primary|Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale|Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.|||score on a scale||Standard Deviation|Mean
1333337|NCT02043145|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)|An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event.|4 Years|Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.|||participants|||Number
1333338|NCT02043132|Secondary|Number of Participants Experiencing Infection as a Surgical Site Complication|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Infection"|up to 6-weeks post-operatively||||Participants|||Count of Participants
1333339|NCT02043132|Secondary|Number of Participants Experiencing Hematoma as a Surgical Site Complication|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Hematoma"|up to 6-weeks post-operatively||||Participants|||Count of Participants
1333340|NCT02043132|Secondary|Number of Participants Experiencing Deep Vein Thrombosis|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Deep venous thrombosis"|up to 6-weeks post-operatively||||Participants|||Count of Participants
1334060|NCT02029521|Primary|Height Percentile|The subjects were measured over the course of the study to determine if treatment improved height percentile.|6 Months|All participants.|||Percentile adjusted for age and sex||Standard Deviation|Mean
1333341|NCT02043132|Secondary|Number of Participants Experiencing Myocardial Infarction|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Myocardial infarction"|up to 6-weeks post-operatively||||Participants|||Count of Participants
1333342|NCT02043132|Secondary|Number of Participants Experiencing Pulmonary Embolism|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Pulmonary Embolism"|up to 6-weeks post-operatively||||Participants|||Count of Participants
1333343|NCT02043132|Primary|Total Drain Output|Total Drain Output as measured postoperatively 0-48 hours|0-48 hours postoperatively||||mL||95% Confidence Interval|Mean
1333344|NCT02043132|Primary|Total Hemoglobin Loss|Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x [Hb(initial)(g/L) - Hb(final)(g/L)] + Hb(transfused)|Preoperative through Postoperative Days 1 and 2||||g||95% Confidence Interval|Mean
1333345|NCT02043132|Primary|Total Blood Loss|Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)|Preoperative through Postoperative Days 1 and 2||||Total Blood Loss (mL)||Standard Deviation|Mean
1333346|NCT02043015|Secondary|Acceptability of Provider Training|Measured as the number of providers who accept the training related to MSM-specific healthcare.|12 months|The mandatory MSM-specific training had already been completed for health care providers in Cape Town, thus the training specified by the study protocol was no longer necessary.||||||
1333347|NCT02043015|Secondary|Acceptability of Post-exposure Prophylaxis (PEP)|Measured as the number of men who report an eligible exposure who accept and initiate PEP.|12 months|Participants who tested HIV-negative at baseline and were followed prospectively.|||Participants|||Count of Participants
1333348|NCT02043015|Secondary|Serodiscordant Unprotected Anal Intercourse (UAI)|Measured as any self-reported unprotected anal intercourse in the last three or six months with a partner of opposite or unknown HIV status, as self-reported in the questionnaire at each study visit.|Month 3, 6, and 12|The analysis population includes all prospectively followed participants who completed the survey.|||Participants|||Count of Participants
1333349|NCT02043015|Secondary|Number of HIV Tests During Study|The number of HIV tests per participant administered during the study period.|12 months|This analysis includes all participants enrolled for prospective follow-up at baseline.|||HIV tests||Standard Deviation|Mean
1333350|NCT02043015|Secondary|Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake|VCT and CVCT is measured as the number and percentage of participants who completed VCT in the study period as part of the study visits and the number and percentage of participants who self-reported VCT outside of their study visits. These are compared to the number and percentage of participants who self-reported having VCT in the year prior at baseline. CVCT is measured as the number and percentage of participants who completed a CVCT session as part of the study.|12 months|Participants who tested HIV-negative at baseline and were enrolled for prospective follow-up.|||Participants|||Count of Participants
1333351|NCT02043015|Secondary|Lubricant Use|Measured as the number and percentage of participants who used condom-compatible lubricant during their most recent anal sex act, among those who also used a condom at their most recent anal sex act.|Months 3, 6, and 12|This analysis includes all participants enrolled for prospective follow-up at baseline who self-reported using a condom during their most recent anal sex reported.|||Participants|||Count of Participants
1333352|NCT02043015|Secondary|Condom Use|Condom use is measured as the number of male anal sex partners that the study participant always used condoms with in the prior three or six months, as self-reported reported in the questionnaire at each study visit.|Months 3, 6, and 12|This analysis includes all participants enrolled for prospective follow-up at baseline.|||Sex partners|Sex partners||Count of Units
1333353|NCT02043015|Primary|Number of Participants With New HIV Infection|Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.|12 months|The population includes all participants who were HIV-negative at baseline.|||Participants|||Count of Participants
1333354|NCT02043015|Primary|Use of PrEP|Uptake of PrEP by study participants was measured as the number and percentage of enrolled participants eligible for PrEP at the baseline and 3-month study visits who choose to initiate PrEP at a visit one month later.|4 months|Of the 80 participants who were HIV-negative at the baseline visit, 60 were PrEP-eligible based on behavioral and clinical criteria. At the Month 3 visit, participants who were not already on PrEP could be assessed for PrEP eligibility again. Participants could be counted as PrEP-eligible at both the Baseline and Month 3 time points.|||Participants|||Count of Participants
1333355|NCT02043015|Primary|Retention in the Cohort|The ability of the study to retain participants for full study period was assessed. Retention was measured by the number and percentage of enrolled participants attending study visits through the 12-month study period.|12 months|This analysis includes all participants enrolled for prospective follow-up at baseline. Twenty of the participants tested HIV-positive at baseline, and the remaining 80 tested HIV-negative.|||Participants|||Count of Participants
1333356|NCT02042924|Primary|Percentage of Proliferating Bone Marrow in the Femur|The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.||||||
1333357|NCT02042924|Primary|Difference in Water Fat|The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.||||||
1333358|NCT02042924|Primary|Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days|The difference in percentage of proliferating bone marrow will be calculated for the following sites: skull, proximal humeri, ribs, clavicles, cervical spine, thoracic spine, lumbar spine, sacrum, pelvis and proximal femur.|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.||||||
1333359|NCT02042911|Secondary|Number of Subjects With Clinically Significant Physical Examination Values|Number of subjects with abnormal or severe values of vital signs, electrocardiogram, and physical examination including ECOG performance status|Up to 30 months||||participants|||Number
1333360|NCT02042911|Secondary|Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to adverse event|Up to 30 months||||participants|||Number
1333361|NCT02042911|Secondary|Adverse Events|All undesirable medical events experienced by the subject treated with the investigational product (including abnormal changes in laboratory values) are treated as adverse events and evaluated for safety.|Up to 30 months||||participants|||Number
1333362|NCT02042911|Secondary|Overall Survival (OS)|The period from the date of patient registration to the date of death.|Up to 30 months||||months||95% Confidence Interval|Median
1333363|NCT02042911|Secondary|Duration of Remission|The period from the day of CR or PR confirmation to recurrence/relapse.|Up to 30 months||||months||95% Confidence Interval|Median
1333364|NCT02042911|Secondary|Progression-free Survival (PFS)|The period from the first day of the study drug administration (Day1) to progressive disease (PD), recurrence/relapse, or death.|Up to 30 months||||months||95% Confidence Interval|Median
1333365|NCT02042911|Secondary|Complete Remission Rate (CR+CRi) Based on IWCLL Guideline||Up to 30 months||||Percentage of participants||95% Confidence Interval|Number
1333366|NCT02042911|Secondary|National Cancer Institute-sponsored Working Group (NCI-WG) Response Rate (CR+nPR+PR) Based on IWCLL Guideline|"The criteria for nPR and PR based on IWCLL guideline are shown below.~nPR: Fulfills all CR criteria other than residual lymphoid nodules confirmed by bone marrow examination.~PR: Fulfills two or more items from Group A and one or more items from Group B for a minimal duration of 8 weeks.~Group A;~50% or greater reduction in lymphocyte count in peripheral blood from baseline~50% or greater reduction (size reduction) in Sum of the products of the greatest diameters (SPD) and no new lesion emergence or no new enlarged lymph node~A decrease in the size of the liver and/or spleen by 50% more~A decrease in marrow infiltration or lymphoid nodules by 50% more Group B;~1) Neutrophil count ＞1.5×10^9/L or 50% improvement from baseline 2) Platelet count ＞100×10^9/L or 50% improvement from baseline 3) Hemoglobin 11.0 g/dL or 50% improvement from baseline without transfusions"|Up to 30 months||||Percentage of participants||95% Confidence Interval|Number
1333367|NCT02042911|Primary|Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline|"The criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR).~CR: Assessment should be made at least 8 weeks after completion of administration.~Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter)~No hepatomegaly or splenomegaly~Absence of B symptoms~Meet the following laboratory test values;~lymphocyte count in peripheral blood: ＜4.0×10^9/L~neutrophil count: ＞1.5×10^9/L~platelet count: 100×10^9/L~hemoglobin: 11.0 g/dL without transfusions~less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules).~No new lesion emergence~CRi: Fulfills all of the following criteria~Delayed anemia, thrombocytopenia, or neutropenia is observed.~Fulfills all CR criteria other than 4).~Delayed symptoms are all judged to be caused by drug."|Up to 30 months||||Percentage of participants||95% Confidence Interval|Number
1333368|NCT02042872|Secondary|Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the total hip.|Baseline and 12 months||||g/cm2||Standard Deviation|Mean
1333369|NCT02042872|Primary|Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the distal femur and proximal tibia by using a customized research software program supplied by the manufacturer. This measurement will be the primary determinant (dependent measure) of difference among the treatment and control groups, and they will be followed over time at the previously specified time points.|Baseline and 12 months||||g/cm2||Standard Deviation|Mean
1333370|NCT02042534|Secondary|Number of Participants With Modified Rankin Score of 0 or 1 at Week 4|"modified Rankin Score~0 : No symptoms at all~: No significant disability despite symptoms; able to carry out all usual duties and activities~: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~: Moderate disability; requiring some help, but able to walk without assistance~: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~: Severe disability; bedridden, incontinent and requiring constant nursing care and attention~: Dead"|at 1 month|Modified ITT (mRS 0,1 at Week 4, n(%)|||participants|||Number
1333371|NCT02042534|Secondary|Length of Hospitalization|Time to event will be calculated|at 1month||||days||Standard Deviation|Mean
1333372|NCT02042534|Secondary|The Number of Patients With Recurrent Ischemic Lesion|Recurrent ischemic lesion confirmed by relevant neuroimagings|at 1 month|Modified ITT|||Participants|||Number
1333373|NCT02042534|Secondary|The Number of Patients With Intracranial Bleeding|Intracranial bleeding confirmed by relevant neuroimagings|at 1 month|Modified ITT|||Participants|||Number
1333374|NCT02042534|Primary|Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging|"Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month~Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 1 month"|1 month after randomization|"modified Intention to treat: 95 / 88 (Rivaroxaban/Warfarin)~Per protocol: 93 / 87 (Rivaroxaban/Warfarin)~Safety: 98 / 90 (Rivaroxaban/Warfarin)"|||Participants|||Number
1333375|NCT02042443|Secondary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
1333388|NCT02042131|Secondary|Beck Scale for Suicide Ideation (BSSI)|The BSSI is used to evaluate the intensity of the patient’s specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation.|1 month, 3 months, and 6 months||||units on a scale||Standard Error|Mean
1333376|NCT02042443|Secondary|Objective Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 2 years from registration|All eligible and analyzable patients with measurable disease.|||Participants|||Count of Participants
1333377|NCT02042443|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse event reporting followed the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 2 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.|||Participants|||Count of Participants
1333378|NCT02042443|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
1333379|NCT02042404|Other Pre-specified|Determine the Incidence of Serious Device- and Procedure-related Adverse Events.|The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.|120 days|Both Primary Cohort and Roll-in Cohort were included in all safety analyses.|||serious device- or procedure-related AEs|||Number
1333380|NCT02042404|Secondary|Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.|Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.|||dB difference in HINT scores||Standard Deviation|Mean
1333381|NCT02042404|Secondary|Functional Gain Over the Frequency Range From 2000 to 10,000 Hz|10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.|||dB difference in Soundfield Hearing||Standard Deviation|Mean
1333382|NCT02042404|Primary|Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment|"The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of No Hearing Change for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less."|Baseline and 120 days|43 subjects available for analysis between enrollment/treatment and 120 day measurement.|||dB difference in Unaided Hearing||Standard Deviation|Mean
1333383|NCT02042404|Primary|Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.|Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.|||percentage of words correctly identified||Standard Deviation|Mean
1333384|NCT02042274|Secondary|Blood Glucose|Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.|Baseline, 3 months, 5 months||||mmol/L||Standard Deviation|Mean
1333385|NCT02042274|Primary|Blood Triglyceride|Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.|Baseline, 3 months, 5 months|Healthy adults, ranging in age from 18-65 years.|||mmol/L||Standard Deviation|Mean
1333386|NCT02042131|Other Pre-specified|Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician|Doctoral-level clinicians (i.e., physicians or psychologists) who were blind to treatment condition made a determination regarding psychiatric inpatient admission (either admit or not admit) immediately following the intervention.|Immediately post-intervention||||Participants|||Count of Participants
1333387|NCT02042131|Secondary|Inpatient Psychiatric Hospitalization Days|Mean number of days of inpatient psychiatric hospitalization|6 months||||days||Standard Error|Mean
1333412|NCT02041325|Secondary|Quantity of Subjects With a T-cell Response|Participants who displayed a T cell responses against HbSAg following vaccination|6 weeks||||participants|||Number
1333413|NCT02041325|Secondary|Safety|Number of participants with adverse events as a measure of safety and tolerability|6 weeks||||participants|||Number
1333389|NCT02042131|Primary|Estimated Proportion of Participants With Suicide Attempt|Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent|6 months|all participants enrolled, regardless of dropout or withdrawal|||estimated proportion of participants|||Number
1333390|NCT02041533|Secondary|Disease-related Symptom Improvement Rate by Week 12|The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.|From date of randomization to week 12|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
1333391|NCT02041533|Secondary|Time to Response in Participants With PD-L1 Expression >= 5%|Time to Response (TTR) was defined as the time from randomization to the date of the first response (CR or PR), as assessed by IRRC assessment. TTR was evaluated for responders only. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months)|All randomized participants with a confirmed response and PD-L1 expression >= 5%|||months||Full Range|Median
1333392|NCT02041533|Secondary|Duration of Response in Participants With PD-L1 Expression>= 5%|Duration of Response (DOR) was summarized for participants with objective response and was defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression as determined by IRRC assessment (per RECIST v1.1) or death due to any cause, whichever occurs first. DOR censoring rules were the same as the PFS primary definition. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir|From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months)|All randomized participants with a confirmed response and PD-L1 expression >= 5%|||months||Full Range|Median
1333393|NCT02041533|Secondary|Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%|ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression >= 5%|||Percentage of participants||95% Confidence Interval|Number
1333394|NCT02041533|Secondary|Overall Survival in All Randomized Participants|Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.|From date of randomization to date of death (assessed up to August 2016, approximately 28 months)|All randomized participants|||months||95% Confidence Interval|Median
1333395|NCT02041533|Secondary|Overall Survival in Participants With PD-L1 Expression >= 5%|Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.|From date of randomization to date of death (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression >= 5%|||months||95% Confidence Interval|Median
1333396|NCT02041533|Secondary|Progression-Free Survival in All Randomized Participants|Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.|From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)|All randomized participants|||months||95% Confidence Interval|Median
1333414|NCT02041325|Primary|Positive for Hepatitis B Surface Antigen|The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).|6 weeks||||participants|||Number
1333415|NCT02041286|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour||||participants|||Number
1333397|NCT02041533|Primary|Progression-Free Survival in Participants With PD-L1 Expression >= 5%|Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.|From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression levels >= 5%|||months||95% Confidence Interval|Median
1333398|NCT02041520|Secondary|Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||UI/L||95% Confidence Interval|Mean
1333399|NCT02041520|Secondary|Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||UI/L||95% Confidence Interval|Mean
1333400|NCT02041520|Secondary|Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM||95% Confidence Interval|Mean
1333401|NCT02041520|Secondary|Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM||95% Confidence Interval|Mean
1333402|NCT02041520|Secondary|Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||copies/ml||95% Confidence Interval|Mean
1333403|NCT02041520|Secondary|Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM/ml||Standard Deviation|Mean
1333404|NCT02041520|Secondary|Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM||95% Confidence Interval|Mean
1333405|NCT02041520|Primary|Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||nM/mg protein||95% Confidence Interval|Mean
1333406|NCT02041377|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour||||participants|||Number
1333407|NCT02041377|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|133 (134-1) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol.|||Blood glucose results|||Number
1333408|NCT02041377|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|129 (134-5) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had low blood sugar and AST result was not evaluable per protocol. One subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.|||Blood glucose results|||Number
1333409|NCT02041377|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|131 (134-3) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.|||Blood glucose results|||Number
1333410|NCT02041377|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|132 (134-2)Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had no fingerstick result.|||Blood glucose results|||Number
1333411|NCT02041325|Secondary|Phenotypic Changes|Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.|6 weeks||||cells/cmm||Full Range|Median
1333416|NCT02041286|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE.|||Blood glucose results|||Number
1333417|NCT02041286|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|130 (136-6) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for one (1) subject. Three (3) subjects had low blood sugar; AST results were not evaluable per protocol.|||Blood glucose results|||Number
1333418|NCT02041286|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|132 (136-4) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject lab reference replicates were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.|||Blood glucose results|||Number
1333419|NCT02041286|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available.|||Blood glucose results|||Number
1333420|NCT02041221|Primary|Number of Subjects With Adverse Events|The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients|Two (2) Weeks||||participants|||Number
1333421|NCT02041091|Secondary|Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications|Area under the concentration time curve in medium body weight group after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1333422|NCT02041091|Secondary|Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications|Maximum serum concentration of tabalumab in medium body weight group, after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1333423|NCT02041091|Secondary|Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score|The SQAAQ is a 12-item questionnaire using a 7-point Likert scale (from “Strongly Disagree” as 1 to “Strongly Agree” as 7) that provides assessment of ease of use and confidence with using a prefilled syringe or auto-injector to administer a subcutaneous injection of drug. The 12 items are: A-Easy for me to learn how to use, B-Easy for me to unlock, C- Easy to hold in my hand when I inject my dose, D- Easy to inject my dose, E- Easy to know that my dose is complete, F- Easy to store the device in my refrigerator, G- Easy to remove needle shield/cover, H- Easy to pick up, I- Overall, easy to use, J- The device is stable against my skin during the injection, K- I am confident in my ability to use the device, L- I am confident my dose is complete.|Week 0, Week 4 and Week 8|Safety population: all randomized patients who received at least 1 dose of study treatment.|||units on a scale||Standard Deviation|Mean
1333424|NCT02041091|Secondary|Number of Participants Developing Anti-Tabalumab Antibodies|Participants with treatment-emergent anti-tabalumab antibodies were participants who had any samples from baseline up to and through Week 12 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of tabalumab. Percentage of participants with anti-tabalumab antibodies = (number of participants with treatment-emergent anti-tabalumab antibodies / number of participants assessed)*100.|Week 0 through Week 12|Safety population: all randomized participants who received at least 1 dose of study treatment. Participants with a baseline sample and at least 1 evaluable sample after administration of study drug OR participants with no baseline sample and all evaluable post-baseline samples.|||Participants|||Count of Participants
1334061|NCT02029521|Primary|Weight Percentile|Weight percentile, adjusted for sex and age|6 months|All participants.|||Percentile adjusted for age and sex||Standard Deviation|Mean
1333425|NCT02041091|Secondary|Number of Participants Reporting Incomplete Tabalumab Dose Administration|Participants reporting incomplete dose administration from the study drug administration log.|Week 0 through Week 12|Safety population: all randomized patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1333426|NCT02041091|Secondary|Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight|Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg). PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.|||ug*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1333427|NCT02041091|Secondary|Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight|Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval , stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg).PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1333428|NCT02041091|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose|Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.|||microgram*hour per milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1333429|NCT02041091|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose|Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.|||microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
1333430|NCT02040844|Secondary|Mean RQLQ Score|"The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007).~The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six.~A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
1333431|NCT02040844|Secondary|Mean Allergy Medication Score (AMS)|"Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups.~The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
1333432|NCT02040844|Secondary|Mean Component Scores of the TRSS (Ocular)|"Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the original CP007 study"|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
1333450|NCT02040766|Secondary|Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period|The analysis of change from baseline in the weekly average of daily evening PEF across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening PEF.|Day 1 (baseline), weeks 1-12|Full analysis set|||liters||Standard Error|Least Squares Mean
1333433|NCT02040844|Secondary|Mean Component Scores of the TRSS (Nasal)|"TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks 1 year after completing the original CP007 study."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
1333434|NCT02040844|Secondary|Mean TRSS|"Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo.~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the first study (CP007)."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
1333435|NCT02040844|Primary|Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])|"The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007).~CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3.~AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6."|1 year after completing CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
1333436|NCT02040792|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)||Baseline to 28 days||||mL||Standard Error|Least Squares Mean
1333437|NCT02040779|Secondary|Participants With Findings During Oropharyngeal Examination During Treatment|Oropharyngeal examinations were performed at every visit by a qualified healthcare professional: during treatment visits are summarized. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area for culturing. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation.|Visits at weeks 2, 4, 8, 12|Safety population|||Participants|||Count of Participants
1333438|NCT02040779|Secondary|Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period|"Criteria for the select vital signs that showed a potentially clinically relevant abnormal result are:~Sitting systolic BP (low); <=90 mm Hg and decrease of >=20 mm Hg from baseline~Sitting diastolic BP (high): >=105 mm Hg and increase of >=15 mm Hg from baseline~Baseline is defined as the last available assessment prior to the first dose of double-blind study treatment (usually Day 1 predose)."|Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12|Safety population|||Participants|||Count of Participants
1333439|NCT02040779|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition.|Day 1 up to Week 12|The safety population included all randomly assigned patients (ITT population) who took 1 or more doses of study drug. In this population, treatment was assigned based upon the treatment patients actually received, regardless of the treatment to which they were randomized.|||Participants|||Count of Participants
1333440|NCT02040779|Secondary|Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period|"A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient’s overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol."|Treatment period: Day 1 up to Week 12|Full analysis set|||Participants|||Count of Participants
1333441|NCT02040779|Secondary|Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period|"The time to patient study drug treatment withdrawal due to worsening asthma was defined as the number of days elapsed from the date of randomization to the date of withdrawal due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient’s overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol."|Treatment period: daily from Day 1 up to Week 12|Full analysis set|||days||95% Confidence Interval|Median
1333442|NCT02040779|Secondary|Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"Asthma symptom scores were recorded in the patient’s diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications.~The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9.~Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of study treatment, including the morning assessment at the randomization visit.~The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy,"|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|Full analysis set|||units on a scale||Standard Error|Least Squares Mean
1333443|NCT02040779|Secondary|Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12|"Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control.~The LS means, difference of LS means and its 95% CI, and p-value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week and treatment by week interaction.~Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including morning usage at the randomization visit."|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|FAS|||inhalations||Standard Error|Least Squares Mean
1333444|NCT02040779|Secondary|Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period|"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.~The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction."|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|Full analysis set|||L/minute||Standard Error|Least Squares Mean
1333445|NCT02040779|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period|"Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 12-week treatment period.~PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts.~Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit.~The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction."|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|Full analysis set (FAS)|||L/minute||Standard Error|Least Squares Mean
1333446|NCT02040779|Primary|Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received|"The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'.~The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment."|Baseline (Day 1 predose), weeks 2, 4, 8 and 12|The full analysis set (FAS) included all patients in the intent to treat (ITT) population who received at least 1 dose of study drug and had at least 1 postbaseline trough morning (pre-dose and pre-rescue bronchodilator) assessment of FEV1.|||liters||Standard Error|Least Squares Mean
1333447|NCT02040766|Secondary|Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period|"Time to withdrawal due to meeting stopping criteria was defined as number of days elapsed from the date of first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria.~Kaplan-Meier estimates (median and 95% CI of the median) are not applicable if the proportion of participants withdrawn is less than 0.5."|Day 1 to 12 weeks|Full analysis set|||Days||95% Confidence Interval|Median
1333448|NCT02040766|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12|The total daily asthma symptom score is the average of the daytime and nighttime scores analyzed using an mixed model for repeated measures (MMRM). Baseline was defined as the average of recorded morning and evening asthma symptom scores over the 7 days before randomization. Daytime Scores range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities; Nighttime Scores range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The daily asthma symptom score was therefore 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night.|Day 1 (baseline), weeks 1-12|Full analysis set|||units on a scale||Standard Error|Least Squares Mean
1333449|NCT02040766|Secondary|Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12|The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) across the 12 weeks was analyzed using a mixed model for repeated measures (MMRM).|Day 1 (baseline), weeks 1-12|Full analysis set|||Number of inhalations||Standard Error|Least Squares Mean
1333451|NCT02040766|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF calculated across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF.|Day 1 (baseline), weeks 1-12|Full analysis set|||liters||Standard Error|Least Squares Mean
1333452|NCT02040766|Primary|Standardized Baseline-adjusted Trough Morning Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk))|Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. Baseline was defined as baseline trough morning percent predicted FEV1. Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used.|Day 1 (baseline), Weeks 2, 4, 8, 12|The full analysis set (FAS) included all patients in the ITT population who received at least 1 dose of study drug and had at least 1 post baseline trough morning (pre-dose and pre-rescue bronchodilator) assessment of percent predicted FEV1.|||liters||Standard Error|Least Squares Mean
1333453|NCT02040623|Primary|Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.|Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.|Baseline to 12 weeks|The per-protocol (PP) population excludes subjects with significant protocol deviations or with early study termination|||units on a scale||Standard Deviation|Mean
1333454|NCT02040532|Other Pre-specified|Quality of Life-Menopause Specific|"The Quality of life-Menopause specific is assessed by the Menopause Specific Quality of Life (MENQOL).~The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1–3), psychosocial (items 4–10), physical (items 11–26), and sexual (items 27–29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain’s items by the number of items within that domain. Non-endorsement of an item is scored a “1” and endorsement a “2,” plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had MENQOL data at baseline and study completion.|||scores on a scale||Full Range|Mean
1333455|NCT02040532|Other Pre-specified|Quality of Life-Overall|Quality of life-Overall was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a 16-item self-report questionnaire that assesses enjoyment of and satisfaction with life. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70 with higher scores indicating higher quality of life enjoyment and satisfaction.|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had Q-LES-Q data at baseline and study completion.|||scores on a scale||Full Range|Mean
1333456|NCT02040532|Primary|Sleep Quality and Disturbances Over Past Month|"Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score.~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had PSQI data at baseline and study completion.|||scores on a scale||Full Range|Mean
1333457|NCT02040532|Primary|Severity of Insomnia|"Severity of insomnia was measured throughout the study using the Insomnia Severity Index (ISI) .The ISI is a 7-item scale that evaluates the severity of insomnia retrospectively over the past week. The scale is more specific to insomnia symptoms than the Pittsburgh scale (PSQI), which focuses more broadly on overall sleep quality.~The ISI score ranges from a minimum of 0 to 28. A score of 0-7=no clinically significant insomnia, 8-14=subthreshold insomnia, 5-21=clinical insomnia (moderate severity), 22-28=clinical insomnia (severe), with higher values indicating more severe insomnia."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had ISI data at baseline and study completion.|||scores on a scale||Full Range|Mean
1333458|NCT02040532|Primary|Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.|Baseline, study completion at 7 weeks|Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.|||vasomotor symptoms (VMS) per night||Full Range|Mean
1333472|NCT02039817|Secondary|Levels of cCK18|Biomarker cCK18 (Cleaved cytokeratin 18) PK evaluations from pre-dose to 48 hours|48 hours||||U/L||Inter-Quartile Range|Median
1333473|NCT02039817|Primary|AUC|Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast|48 hours|7 subjects were used in the calculation of AUC0-inf for the healthy volunteer group as one subject had no identifiable terminal log-linear phase.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333474|NCT02039778|Secondary|Quality of Life|The impact of ScRT on health-related quality of life (HRQOL) as assessed by EORTC Quality of Life Questionnaire (EORTC QLQ-C30)/Brain Cancer Module (BCM 20), Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and Activities of Daily Living Scale (ADLS) during ScRT.|36 months|no data available due to no subject completed the study. data not collected||||||
1333459|NCT02040532|Primary|Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.|Baseline, study completion at 7 weeks|Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.|||vasomotor symptoms (VMS) per day||Full Range|Mean
1333460|NCT02040532|Primary|Reason for Non-tolerability and Discontinuation of Gabapentin|Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion|Baseline, Week 4 Visit, and study completion at 7 weeks|Four subjects initiated treatment with gabapentin but discontinued prior to study completion due to side effects.|||Participants|||Count of Participants
1333461|NCT02040532|Primary|Tolerability of Gabapentin|Tolerability of gabapentin was assessed by self-report at the week 1, week 4 and week 7 contacts by asking participants to complete the SAFTEE-SI and CPFQ questionnaires and prompting subjects to report any adverse events at each study visit. Tolerability of gabapentin is defined as the proportion of participants that is able to increase the dose from 300-mg to 600-mg and to remain on the higher dose for the duration of the trial.|Baseline, Week 4 visit, and study completion at 7 weeks|All 26 participants who initiated treatment with gabapentin were included in this analysis.|||Participants|||Count of Participants
1333462|NCT02040428|Secondary|Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment|The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS|Intra-operative, prior initiation of final chest wall closure.||||Participants|||Number
1333463|NCT02040428|Secondary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.|Intraoperative, 10 minutes following treatment application||||Participants|||Number
1333464|NCT02040428|Secondary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.|Intraoperative, 6 minutes following treatment application|The secondary endpoint analyses were based on the Intent to Treat (ITT) analysis set.|||Participants|||Number
1333465|NCT02040428|Primary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.|Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure|Intraoperative, 3 minutes following treatment application|The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set, consisting of all randomized subjects.|||Participants|||Number
1333466|NCT02040116|Primary|Grade of Infusion Related Reactions With Rapid Infusion Will be Reported|Patients are given therapy on day 1 and if infusion is tolerated with < grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The grade of infusion reaction is measured for all patients and in all infusions given. According to the National Cancer Institute, there are 5 grades of IRR. In general, grade 1 reactions are classified as asymptomatic or only mild symptoms that do not require intervention. Grade 2 reactions are classified as moderate with minimal, local, or noninvasive interventions required. Grade 3 reactions are classified as severe and medically significant, but not immediately life-threatening. These reactions require hospitalization or prolongation of a current hospitalization. Grade 4 reactions are classified as life-threatening with urgent interventions required. Grade 5 reactions are classified as death related to an adverse drug event.|14 Days|Due to their being no reactions, the Grade of reactions for Standard infusion will and can not be reported, as the lowest grade requires there to be a reaction.||||||
1333467|NCT02040116|Secondary|Change in Chair Time With Rapid Infusion Will be Reported|The amount of time spent administering the rituximab will be compared to the time from the first infusion to the second infusion. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|14 Days||||Hours||Full Range|Mean
1333468|NCT02040116|Primary|Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported|Patients are given therapy on day 1 and if infusion is tolerated with < grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The number of infusion reaction is measured for all patients and in all infusions given.|14 Days||||infusion reactions|||Number
1333469|NCT02040077|Secondary|Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.|Participant willingness (yes or no) to recommend the intervention to a family member or friend.|Immediately after the intervention (an average of 10 minutes).||||Participants|||Count of Participants
1333470|NCT02040077|Primary|Knowledge Gain|"The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention.~At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as true, false, or I don't know (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses."|Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.||||units on a scale||Standard Deviation|Mean
1333471|NCT02039817|Primary|Cmax|Maximum concentration (Cmax)|48 hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333475|NCT02039778|Secondary|Neurocognition|The potential neurocognitive effects of ScRT by the Hopkins Verbal Learning Test (HVLT), Mini-mental status exam (MMSE), Trail Making Tests A/B (TMT), and Controlled Word Association Test (COWAT).|36 month|no data available due to no subject completed the study. data not collected||||||
1333476|NCT02039778|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The short-and long-term toxicity of ScRT (and compare to historical controls).|36 months||||Participants|||Count of Participants
1333477|NCT02039778|Primary|Progression-free Survival|The progression-free survival of patients with newly diagnosed HGG treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).|12 months|no data available due to no subject completed the study. data not collected||||||
1333478|NCT02039778|Primary|Overall Survival|The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).|12 months||||Participants|||Count of Participants
1333479|NCT02039687|Secondary|Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters|Patients reporting at least one treatment emergent adverse event (TEAE) or serious TEAE|Continuous reporting from baseline through 16 weeks||||Participants|||Count of Participants
1333480|NCT02039687|Secondary|Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires|"Change in mean score from baseline to Day 28 is recorded for each outcome. Brief Pain Inventory (BPI), Pain Severity - scale of 0 (no pain) to 10 (worst pain imaginable) in 4 time frames, averaged.~BPI, Pain Interference - scale of 0 (does not interfere) to 10 (completely interferes) how pain interferes with 7 lifestyle parameters, averaged.~Small Fiber Neuropathy Screening List (SFNSL) - scale of 0 to 84 (higher score indicates greater neuropathy), sum of 21 questions.~Neuropathic Pain Symptom Inventory (NPSI) - scale of 0 (least pain) to 10 (most pain) in 10 questions, summed. Total score range from 0 to 100.~Fatigue Assessment Scale (FAS) - scale of 1 (never) to 5 (always) in 10 questions related to fatigue, summed. Total score range from 0 to 50, with 0 being the best possible score and 50 the worst.."|Baseline to 28 days|Questionnaires incomplete for some subjects|||units on a scale||Standard Deviation|Mean
1333481|NCT02039687|Secondary|Change in Intra-epidermal Nerve Fiber Density (IENFD)|Measurement of small fiber density in skin biopsies. Density is reduced in sarcoidosis patients, an indication of neuropathy.|Baseline and 28 days||||fibers/mm||Standard Deviation|Mean
1333482|NCT02039687|Secondary|Change in the 6 Minute Walk Test|Measurement of the distance a patient can walk in 6 minutes|Baseline and 28 days||||meters||Standard Deviation|Mean
1333483|NCT02039687|Primary|Change in Corneal Nerve Fiber Area|Measurement of corneal nerve fiber area is a non-invasive procedure performed at baseline and at the end of dosing and at 12 weeks follow-up. The nerve fiber area in sarcoidosis patients is reduced compared to normal humans, a measurement of small fiber loss.|Baseline and 28 days||||µm^2||Standard Deviation|Mean
1333484|NCT02039674|Secondary|Part 2 Cohort G: Duration of Response (DOR)|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.|Up to 2 years|The analysis population consisted of all randomized Cohort G participants.|||Months||Full Range|Median
1333485|NCT02039674|Secondary|Part 2 Cohort G: Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause.|Up to 2 years|The analysis population consisted of all randomized Cohort G participants.|||Months||95% Confidence Interval|Median
1333486|NCT02039674|Secondary|Part 2 Cohort G: Progression-Free Survival (PFS)|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS was assessed by BICR.|Up to 2 years|The analysis population consisted of all randomized Cohort G participants.|||Months||95% Confidence Interval|Median
1333487|NCT02039674|Primary|All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.|Cycle 1 (Up to 21 days)|The DLT evaluable population consisted of all participants who completed the first cycle of study treatment or who discontinued from the study due to a drug-related AE.|||Participants|||Count of Participants
1333488|NCT02039674|Primary|Part 2 Cohort H: ORR|ORR was defined as the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by BICR.|Up to 2 years|The analysis population consisted of all treated Cohort H participants. One participant was excluded from the efficacy analysis population due to a protocol violation. This participant did not have non-small cell lung cancer.|||Percentage of Participants||95% Confidence Interval|Number
1333489|NCT02039674|Primary|Part 2 Cohort G: Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).|Up to 2 years|The analysis population consisted of all randomized Cohort G participants.|||Percentage of Participants||95% Confidence Interval|Number
1333490|NCT02039427|Other Pre-specified|Potential Side Effects Associated With the Study Drugs|Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.|at 1, 6 and 24 hours after extubation||||Participants|||Count of Participants
1333491|NCT02039427|Secondary|The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy|"The investigator asked scales to patients at 1, 6 and 24h after extubation. PH was assessed using a 4-grade scale (0–3): 0, none; 1, mild (noticed by the patient only); 2, severe (obvious to observer); 3 aphonia (silence of voice)~● Incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign"|at 1, 6 and 24 hours after thyroidectomy||||Participants|||Count of Participants
1333492|NCT02039427|Primary|The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy|"The investigator asked scales to patients at 1, 6 and 24h after extubation. POST was defined as discomfort at larynx or pharynx at rest and during swallowing after surgery and was assessed using a 4-grade scale (0–3) based on verbal responses to questions: 0, none; 1, mild (less severe than with a cold); 2, moderate (similar with a cold); 3 severe (more severe than with a cold)~● Incidence of sore throat : if patient rates sore throat scale more than 1, investigator will record as positive symptom."|at 1, 6 and 24 hours after thyroidectomy||||Participants|||Count of Participants
1333493|NCT02039414|Secondary|Maternal Lipid Oxidation|The investigators will measure maternal lipid oxidation rate using indirect calorimetry (True One 2400, Parvo Medics, Sandy, UT) before, during, and after acute exercise. This will involve placing a hoodlike device over the subject's head as they lay supine (rest).During exercise, this involved using a mouthpiece and noseclips. Using both techniques, The investigators will be able to calculate lipid oxidation rates from the volumes of CO2 produced and volumes of O2 used.The reported measure is lipid oxidation rate during exercise. The equation used to calculate lipid oxidation is: lipid oxidation (g/min) = 1.695 VO2- 1.701 VCO2 .|Visit 2 (32-37 weeks gestation)- reported lipid oxidation is the average of lipid oxidation over the course of the 30min exercise bout (i.e. data collected at minutes 8-10, minutes 18-20, and minutes 28-30 of exercise, all averaged together).|Of the 40 women consented, only 32 (16 per group) completed all study visits and have lipid oxidation data.|||g/min||Standard Deviation|Mean
1333494|NCT02039414|Secondary|Maternal Inflammation|High-Sensitivity C-reactive protein was measured.|This was taken while fasted and under resting conditions at the beginning of visit 2 (between 32 and 37 weeks gestation). This value was only measured at baseline (i.e. one timepoint).|Of the 40 women consented, only 32 (16 in each group, completed the study visits). Thus, these 32 have CRP data.|||mg/L||Standard Deviation|Mean
1333495|NCT02039414|Primary|Neonatal Insulin Resistance|Infant HOMA-IR will be determined by measuring umbilical cord plasma glucose and insulin concentrations at parturition vis cord blood collection. Cord blood will be collected within 30 min of delivery, centrifuged for 10 min at 3000rpm to remove plasma, and stored at -80.|Immediately after delivery|We could not obtain cord blood on all infants (thus, specimens were obtained fro 14 obese active and 12 obese inactive women). Due to medical emergencies or lack-of cord blood available, there were several instances where these specimens could not be obtained by the study team.|||HOMA_IR, unitless measure||Standard Deviation|Mean
1333496|NCT02039414|Primary|Neonatal Adiposity|Within 48 hours of delivery, neonatal body composition (% fat mass) will be measured by skin fold thickness measurement and by air displacement plethysmography (Pea Pod, Life Measurement, Inc., Concord, CA) in the CRU at WUSM.|24-48 hr after delivery|Several babies were not able to be measured for this part of the study- the primary reason being a weekend delivery that was discharged before measurements could be obtained by the study team. Our clinical research unit was not open on weekends to the the Peapod scans. This explains why there were only 15 babies per group for this outcome.|||% fat||Standard Deviation|Mean
1333497|NCT02039115|Primary|Stricture Formation|Primary outcome measure is the rate of symptomatic esophageal stricture formation.|98 weeks||||Participants|||Count of Participants
1333498|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
1333499|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 9 participants from the usual care arm and 9 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
1333500|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 12 participants from the usual care arm and 7 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
1333501|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 11 participants from the usual care arm and 7 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
1333502|NCT02038959|Secondary|Minutes Spend on Last Parkinson's Disease Provider Visit||One year|Data was not collected on 10 participants in the usual care arm and 28 participants in the virtual visits arm.|||minutes||Inter-Quartile Range|Median
1333994|NCT02030535|Secondary|Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333503|NCT02038959|Secondary|Change in Patient Assessment of Chronic Illness Care|We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team.|baseline to one year|Data was not collected in 16 participants from the usual care arm and 12 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
1333504|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 8 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
1333505|NCT02038959|Secondary|Change in Montreal Cognition Assessment|We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition.|baseline to one year|Data was not collected on 6 participants in the usual care arm and 9 participants in the virtual visits arm.|||units on a scale||Standard Error|Mean
1333506|NCT02038959|Secondary|Change in EQ-5D Index Value|EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
1333507|NCT02038959|Primary|Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39|Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson’s disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson’s Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.|Baseline to One year|Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm.|||units on a scale||Standard Error|Mean
1333508|NCT02038959|Primary|Feasibility of Virtual Visits for Parkinson Disease|Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.|One year||||participants|||Number
1333509|NCT02038946|Secondary|Overall Response Rate (ORR) Based on Investigator Assessments|"ORR is determined by investigator assessments according to the 2007 revised IWG Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants.~CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.~PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)"|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017)|All treated participants|||percentage||95% Confidence Interval|Number
1333510|NCT02038946|Secondary|Progression Free Survival (PFS) Based on IRRC Assessment|PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation.|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017)|All treated participants|||months||95% Confidence Interval|Median
1333511|NCT02038946|Secondary|Partial Remission (PR) Rate Based on IRRC Assessment|"PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 revised IWG Criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage.~PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)"|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017)|All treated participants|||percentage||95% Confidence Interval|Number
1333512|NCT02038946|Secondary|Complete Remission Rate (CRR) Based on IRRC Assessment|"CRR is defined as the number of subjects with a BOR of CR according to the 2007 revised IWG Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage.~CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement."|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017)|All treated participants|||percentage||95% Confidence Interval|Number
1333513|NCT02038946|Secondary|Duration of Response (DOR) Based on IRRC Assessments|"DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first.~CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.~PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)"|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017)|All treated participants|||months||95% Confidence Interval|Median
1333536|NCT02038907|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Baseline (Day 1) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333514|NCT02038946|Primary|Overall Response Rate (ORR) as Determined by IRRC|ORR is determined by an independent radiologic review committee (IRRC) according to the 2007 revised International Working Group (IWG) Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the total number of treated participants and expressed as a percentage. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017)|All treated participants|||percentage||95% Confidence Interval|Number
1333515|NCT02038933|Secondary|Objective Response Rate (ORR) Per Investigator Assessment|"ORR is defined as the number of subjects with a BOR of CR or PR, according to investigator assessment, divided by the number of treated subjects.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1333516|NCT02038933|Secondary|Progression Free Survival|PFS is defined as the time from first dosing date to the date of the first documented progression, as determined by an IRRC according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first.|From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants|||months||95% Confidence Interval|Median
1333517|NCT02038933|Secondary|Duration of Partial Remission|"Duration of PR is defined as the time from first documentation of PR to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on IRRC assessment, or death due to any cause, whichever occurs first.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (assessed up to April 2016, approximately 25 months)|All participants with BOR of PR|||months||Full Range|Median
1333518|NCT02038933|Secondary|Rate of Partial Remission|"PR rate is defined as the number of subjects with a BOR of PR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From date of first dose to date of documentation of PR (assessed up to April 2016, approximately 25 months)|All treated participants|||Percent of participants with BOR of PR||95% Confidence Interval|Number
1333519|NCT02038933|Secondary|Duration of Complete Remission|"The duration of CR is defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow [if required], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on IRRC assessment, or death due to any cause, whichever occurs first.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (Assessed up to April 2016, approximately 25 months)|All participants with BOR of CR|||months||Full Range|Median
1333520|NCT02038933|Secondary|Complete Remission Rate|Complete Remission Rate is defined as the number of subjects with a BOR of CR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of first dose to date of documented CR|All treated participants|||Percent of participants with BOR of CR||95% Confidence Interval|Number
1333521|NCT02038933|Secondary|Duration of Response (DOR)|DOR is defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of first response to the date of documented disease progression or death, whichever occurs first (assessed up to April 2016, approximately 25 months)|All participants with BOR of CR or PR|||months||95% Confidence Interval|Median
1333522|NCT02038933|Primary|Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment|ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1333723|NCT02035696|Secondary|Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 50 post vaccination over day 1|Analysis was done on PPS|||Ratios||95% Confidence Interval|Number
1333523|NCT02038907|Secondary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participants is unwilling to continue because of the AE.|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333524|NCT02038907|Secondary|Percentage of Participants With Significant New Medical Conditions|"Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder.~Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment."|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333525|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
1333526|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
1333527|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
1333528|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333529|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333530|NCT02038907|Secondary|GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays|"GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
1333531|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333532|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333533|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333534|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333535|NCT02038907|Secondary|Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333995|NCT02030535|Secondary|Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333537|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333538|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333539|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333540|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
1333541|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
1333542|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333543|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333544|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333545|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333546|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333547|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
1333548|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
1333549|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333550|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
1333551|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333552|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333553|NCT02038907|Secondary|Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)|"Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
1333554|NCT02038907|Primary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 393|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333555|NCT02038907|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Day 1 up to Day 56|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333556|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 2|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.|||degrees Celsius||Standard Deviation|Mean
1333557|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 1|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.|||degrees Celsius||Standard Deviation|Mean
1333558|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333559|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333560|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333561|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
1333562|NCT02038907|Primary|Percentage of Participants With a Seroresponse (Pan-Ig ELISA)|Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 56|Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.|||percentage of participants||95% Confidence Interval|Number
1333807|NCT02033499|Secondary|Number of Participants on Specified Diabetes Medications at Baseline and Follow-up|Number of participants taking each of the following medications at baseline and follow-up: metformin, sulfonylurea, glinides, Glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), and dipeptidyl peptidase IV (DPP-IV).|Baseline and 52 weeks|Medication regimens vary among patients.|||Participants|||Count of Participants
1333563|NCT02038829|Secondary|Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)|A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.|Over 7 days|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
1333564|NCT02038829|Secondary|Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)|A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.|Over 7 days|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
1333565|NCT02038829|Secondary|Standardized Change From Baseline in FEV1 AUC(0-12hours)|The standardized FEV1 AUC(0-12) on Day 7 was calculated using the trapezoidal rule from the changes in FEV1 from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval).|Day 7|Efficacy Population: all subjects who were randomized to treatment, received at least one dose of study medication, and had at least one trough FEV1 evaluation and the corresponding baseline FEV1 for at least one treatment period.|||Liters||Standard Error|Least Squares Mean
1333566|NCT02038829|Primary|Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period|Baseline and Day 7|Efficacy Population: all subjects who were randomized to treatment, received at least one dose of study medication, and had at least one trough FEV1 evaluation and the corresponding baseline FEV1 for at least one treatment period.|||liters||Standard Error|Least Squares Mean
1333567|NCT02038790|Secondary|Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)|"Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment.~SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format."|Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)|Per protocol set.||||||
1333568|NCT02038790|Secondary|Dissolution Time of Intervention as Recorded by a Trained Observer|The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||minutes||Standard Deviation|Mean
1333569|NCT02038790|Secondary|Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....|"Choices to the question above are:~More effective as a treatment for opioid dependence~Equally effective as a treatment for opioid dependence~Less effective as a treatment for opioid dependence~The same medication that I normally use"|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333570|NCT02038790|Secondary|Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......|"Choices to the question above are:~Crush and snort~Liquefy and inject~Not able to abuse this formulation"|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333571|NCT02038790|Secondary|Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication|Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333572|NCT02038790|Secondary|Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'|Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333573|NCT02038790|Secondary|Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?|Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333574|NCT02038790|Secondary|Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?|Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333575|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333724|NCT02035696|Secondary|Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~The CHMP criterion is mean geometric ratio (GMR) >2.5"|Day 50 post vaccination over day 1|Analysis was done on FAS|||Ratios||95% Confidence Interval|Number
1333576|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333577|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333578|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333579|NCT02038790|Secondary|Participant Assessments With Regard to Ease of Dissolution of Interventions|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333580|NCT02038790|Secondary|Participant Preference With Regard to Overall Taste of Interventions|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333581|NCT02038790|Primary|Overall Intervention Preference As Assessed by Participants|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
1333582|NCT02038764|Secondary|Accumulation Ratio (Rac) on Day 71|Accumulation ratio was calculated from AUCinf at last dose/AUCinf at first dose, where AUCinf is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). On Day 71, 3 participants in cohort 1 had reportable Rac values.|0, 1, 4, hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 71, 3 participants in cohort 1 had reportable Rac values.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1333583|NCT02038764|Secondary|Apparent Volume of Distribution (Vz/F) on Day 71|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. On Day 71, 1 participant in cohort 1, 5 participants in cohort 2, and 7 participants in cohort 3 had reportable Vz/F values|0, 1, 4 hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 71, 1 participant in cohort 1, 5 participants in cohort 2, and 7 participants in cohort 3 had reportable Vz/F values|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1333584|NCT02038764|Secondary|Plasma Decay Half-Life (t1/2) on Day 71|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. On Day 71, 2 participants in cohort 1, 5 participants in cohort 2, and 7 participants in cohort 3 had reportable values for t1/2|0, 1, 4 hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 71, 2 participants in cohort 1 , 5 participants in cohort 2, and 7 participants in cohort 3 had reportable values for t1/2|||hr||Standard Deviation|Mean
1333585|NCT02038764|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 and Day 71|Time to reach maximum observed plasma concentration was observed directly from data as time of first occurrence on Day 1 and Day 71. On Day 71, 2 participants in cohort 4 had reportable Tmax values|0, 1, 4 hours post-dose on Day 1 and Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed.On Day 71, 2 participants in cohort 4 had reportable Tmax values|||hr||Full Range|Median
1333586|NCT02038764|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 1 and Day 71|Maximum serum concentration was observed directly from data on Day 1 and Day 71. On Day 71, 2 participants in cohort 4 had reportable Cmax values|0, 1, 4 hours post-dose on Day 1 and Day 71|All enrolled participants treated who had at least 1 concentration value. On Day 71, 2 participants in cohort 4 had reportable Cmax values|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333587|NCT02038764|Secondary|Apparent Oral Clearance (CL/F) on Day 71|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. On Day 71, 6 participants in cohort 1 had reportable CL/F values|0,1,4 hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. Day 71, 6 participants in cohort 1 had reportable CL/F values|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
1333888|NCT02032433|Secondary|Problems Related to Drug Abuse|Assessed via the ASI-Lite modules, completed at baseline, week 24, and at each of the follow up visits. Assessed by teh EuroQuol (EQ-5D), completed at baseline, then every 4 weeks and at each follow up visit.|Weeks 0-36|||||||
1333588|NCT02038764|Secondary|Area Under Concentration-Time Curve From Time Zero to Time Tau(AUCtau) on Day 1 and Day 71|Area under the concentration-time profile from time 0 to time tau (τ), the dosing interval, where tau = 168 hours for once a week dosing; tau = 336 hours for once every 2 weeks dosing. On Day 1, 3 participants in cohort 1 had reportable AUCtau values. On Day 71, 6 participants in cohort 1 and 2 participants in cohort 4 had reportable AUCtau values|0,1,4 hours post-dose on Day 1 and Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 1, 3 participants in cohort 1 had reportable AUCtau values. On Day 71, 6 participants in cohort 1 and 2 participants in cohort 4 had reportable AUCtau values|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1333589|NCT02038764|Primary|Number of Participants With Serum Anti-PF-06342674 Antibody Response Listed by Visit|Number of participants with serum anti-PF-06342674 antibody response to the intramuscular tetanus vaccine was reported. Positive Anti-PF-06342674 Antibody response is defined as anti-tetanus toxoid immunoglobulin G (IgG) titer value >=100|Day 1, Day 15, Day 29, Day 57, Day 85, and Day127 and follow-up visits|All participants who received at least 1 dose of study medication.|||participants|||Number
1333590|NCT02038764|Primary|Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Increases From Baseline)|Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg >= 25/50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333591|NCT02038764|Primary|Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Absolute Value)|The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=200 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia’s formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia’s correction) >=500 msec|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333592|NCT02038764|Primary|Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Increases From Baseline)|The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in systolic BP >= 30 mmHg; Criterion B: maximum increase from baseline in diastolic BP >= 20 mmHg|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333593|NCT02038764|Primary|Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Decreases From Baseline)|The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in systolic BP >= 30 mmHg; Criterion B: maximum decrease from baseline in diastolic BP >=20 mmHg|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333594|NCT02038764|Primary|Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Absolute Values)|Number of participants with vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: SBP <90 millimeter of mercury(mmHg); Criterion B: DBP <50 mmHg; Criterion C: pulse rate < 40 beats per minute(BPM); Criterion D: pulse rate >120 BPM|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333595|NCT02038764|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The following laboratory test parameters were evaluated in this study: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),coagulation (partial thromboplastin time, prothrombin, and prothrombin international ratio), liver function(total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose, glycosylated, and hemoglobin), and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, urobilinogen, qualitative bilirubin, nitrites, leukocyte, esterase and microscopy).|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333596|NCT02038764|Primary|Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events Listed by CTCAE Grade|Any blood glucose values <55 mg/dL with or without symptoms was reported as adverse events of hypoglycemia. CTCAE version 4.03 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333597|NCT02038764|Primary|Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events|Number of participants with all-causality treatment-emergent hypoglycemic adverse events was reported. Any blood glucose values less than(<)55 mg/dL with or without symptoms was reported as adverse events of hypoglycemia.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333630|NCT02037776|Secondary|Change From Baseline in Short-form Health Survey-8 (SF-8)|"The SF-8 scores comprised of Physical component summary (PCS) scores (ranging between 5.32-70.69, higher value represents a better outcome) and Mental component summary (MCS) scores (ranging between 10.11-74.51, higher value represents a better outcome), and a total scores of PCS and MCS using a formula specified in SF-8 Scoring Algorithm.~The point scores of SF-8 are calculated from changes from baseline in PCS and MCS at final evaluation."|Baseline and week 8||||units on a scale||Standard Deviation|Mean
1333598|NCT02038764|Primary|Number of Participants With All-Causality TEAEs Listed by Common Terminology Criteria for Adverse Events (CTCAE) Grade|TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. CTCAE version 4.03 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333599|NCT02038764|Primary|Number of Participants With Treatment-Related TEAEs|Number of participants with treatment-related TEAEs were reported. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333600|NCT02038764|Primary|Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs)|Number of participants with all-causality treatment emergent adverse events were reported. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. TEAEs included both serious and non-serious AE|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333601|NCT02038764|Primary|Number of Participants With Dose Limiting or Intolerable Treatment Related Adverse Events (AEs)|Number of participants with dose limiting or intolerable treatment related adverse events (AEs) was reported. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
1333602|NCT02038543|Secondary|Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Glycolate (UGIc)|The overall contribution of Hyp catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled [15N,13C5]-Hyp that is circulating in the plasma.|Participants will be followed for the duration of the study infusion and observations, an average of 24 hours|2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.|||percent converted||Standard Error|Mean
1333603|NCT02038543|Primary|Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Oxalate (UOx)|The overall contribution of hydroxyproline catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled [15N,13C5]-Hyp that is circulating in the plasma.|Participants will be followed for the duration of study infusion and observation, an average of 24 hours.|2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.|||percent converted||Standard Error|Mean
1333604|NCT02038075|Other Pre-specified|Post Treatment Health Interview (PTHI)|Frequency, intensity, and location of each patient’s accessing of medical services will be assessed via medical record review.|24 months|||||||
1333605|NCT02038075|Other Pre-specified|Suicide Cognitions Scale (SCS)|The SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness).|24 months|||||||
1333606|NCT02038075|Other Pre-specified|Interpersonal Needs Questionnaire (INQ)|The INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness).|24 months|||||||
1333607|NCT02038075|Other Pre-specified|Suicide Intent Scale|The SIS is a 15-item, interviewer-administered assessment of the intensity of an individual’s intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters’ perceptions of the attempt.|24 months|||||||
1333608|NCT02038075|Other Pre-specified|Structured Clinical Interview for DSM-IV, Axis I and II (SCID)|The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.|Intake|||||||
1333609|NCT02038075|Secondary|Beck Anxiety Inventory|The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.|24 months|||||||
1333610|NCT02038075|Secondary|Beck Hopelessness Scale (BHS)|The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.|24 months|||||||
1333611|NCT02038075|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.|24 months|||||||
1333612|NCT02038075|Secondary|Scale for Suicide Ideation (SSI)|The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient’s specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.|24 months|||||||
1333629|NCT02037776|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HAD)|"The HAD is a 14-item scale with 2 subscales of depression (Question 1, 3, 5, 7, 9, 11, and 13) and anxiety (Question 2, 4, 6, 8, 10, 12, and 14). Each item on the questionnaire is scored from 0 to 3 (ranging from 0 to 21, lower value represents a better outcome).~The point scores of HAD are calculated from changes from baseline in overall (sum of scores for depression and anxiety, i.e., total point score ranging from 0 to 42, lower value represents a better outcome), depression, and anxiety at final evaluation."|Baseline and week 8||||score||Standard Deviation|Mean
1333613|NCT02038075|Primary|Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up|The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).|24 months|intent to treat|||estimated percentage w/ suicide attempt|||Number
1333614|NCT02038023|Secondary|Safety as Measured by Number of Adverse Events|To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days.|4 weeks after infusion and 4 weeks post-partum||||minor adverse events|||Number
1333615|NCT02038023|Secondary|Percent Transferrin Saturation||4 weeks post infusion or post-partum|Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60|||percent saturation (Fe/TIBC)||Standard Deviation|Mean
1333616|NCT02038023|Secondary|Serum Ferritin||4 weeks post infusion or post-partum|Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60|||ng/mL||Standard Deviation|Mean
1333617|NCT02038023|Primary|Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).||4 weeks after infusion or post-partum|Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60|||Participants|||Count of Participants
1333618|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 72 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333619|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 60 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333620|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 48 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333621|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 36 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333631|NCT02037776|Secondary|Change From Baseline in Global Overall Symptom (GOS)|The GOS scale are calculated by a total score of a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem over 8 questions. The point scores of GOS are calculated from changes from baseline at final evaluation.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1333622|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 24 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333623|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 12 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333624|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 6 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333625|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 3 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333626|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 30 min post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333627|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 15 min post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
1333628|NCT02037893|Primary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)|"The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Baseline and 1 hour after a single dose|Intent-to-Treat population|||units on a scale||Standard Deviation|Mean
1333996|NCT02030535|Secondary|RR Change From Patient Baseline at Individual Post-dose Time Points|RR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333632|NCT02037776|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)|"PAGI-SYM questionnaire is composed of the following 6 categories that consisted of Questions 1 to 20 (each question composed of 6 subscales, i.e., point scores from 0 to 5, lower value represents a better outcome). Subscale scores are calculated by averaging across items in each category. A total score (lower value represents a better outcome, ranging from 0 to 5) is calculated as the mean of the subscale scores.~Heartburn/Regurgitation, Nausea/Vomiting, Postprandial Fullness/Early satiety, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain~The point scores of PAGI-SYM are calculated from changes from baseline in total score and each category score at final evaluation."|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1333633|NCT02037776|Secondary|Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)|"The modified FSSG questionnaire is composed of 7 questions regarding GERD symptoms (Questions 1-7, scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and 7 questions regarding dyspeptic symptoms (Questions 8-14, each question scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and a total scores, ranging from 0 to 56, lower value represents a better outcome of the all questions (Questions 1-14). Each question was assigned a score based on the frequency of symptoms.~The point scores of modified FSSG are calculated from changes from baseline in each score for all symptoms (sum of point scores from Questions 1-14), GERD symptoms, and dyspeptic symptoms at final evaluation."|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1333634|NCT02037776|Primary|Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)|"Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories:~Significantly improved~Improved~Slightly improved~No change~Slightly worse~Worse~Much worse~The numbers of patients at the final evaluation (i.e, the latest evaluable time point of the all patients including discontinued patients) are shown by category."|8 weeks||||Participants|||Count of Participants
1333635|NCT02037607|Primary|Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism|The number of participants with post-operative ultrasound without evidence of thromboembolism|within 72 hours after surgery||||Participants|||Count of Participants
1333636|NCT02037568|Secondary|Caregiver Reaction Assessment|"The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
1333637|NCT02037568|Secondary|Change in Caregiver Telomerase Activity Over Time|Telomerase activity will be assessed as a measure of the ability to reverse cellular aging processes. Because telomerase activity were not normally distributed, the data were log transformed.|Baseline (prior to transplant), 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||log (enzyme unit)||95% Confidence Interval|Least Squares Mean
1333638|NCT02037568|Secondary|Change in Caregiver Telomere Length Over Time|Telomere length was assessed as a measure of cellular aging in blood samples from participants. Because telomere length were not normally distributed, the data were log transformed.|Baseline (prior to transplant), 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||log (T/S ratio)||95% Confidence Interval|Least Squares Mean
1333639|NCT02037568|Secondary|Change in Adrenal Activity Over Time|Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis. Because hair cortisol were not normally distributed, the data were log transformed.|Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant.|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||log (pg/mg)||95% Confidence Interval|Least Squares Mean
1333640|NCT02037568|Secondary|Spielberger State-Trait Anxiety Inventory|"The Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety)."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
1333641|NCT02037568|Secondary|Center for Epidemiological Studies Depression Scale|"Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
1333642|NCT02037568|Secondary|Perceived Stress Scale|"The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
1333643|NCT02037568|Primary|Caregiver Distress - Principal Component Analysis|Caregiver Distress is a composite score is created from a principal component analysis (PCA). This PCA extracted the first principal component from summary variables of Center for Epidemiological Studies Depression Scale, Spielberger State and Trait Anxiety Inventory, and Perceived Stress Scale. The composite distress score has a mean of 0.0 and SD of 1.0, scale ranges from -2.06 - 3.73. Higher score indicates greater distress.|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
1333644|NCT02037568|Primary|Functional Assessment of Cancer Treatment - Blood/Marrow Transplant|"Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT) is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-148. Higher score indicates better life quality."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Patient Control group missing responses (n = 14). Caregiver Intervention group: missing responses (n = 6).|||units on a scale||95% Confidence Interval|Least Squares Mean
1333645|NCT02037477|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with markedly abnormal laboratory values for Chemistry, Hematology and Urinalysis during the study is reported.|At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
1333646|NCT02037477|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings||At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
1333647|NCT02037477|Secondary|Number of Participants With Abnormal Changes From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
1333648|NCT02037477|Secondary|Frequency of Adverse Events|The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.|31 days|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
1333649|NCT02037477|Primary|Intragastric pH Time Course Over 24 Hours|Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.|At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)|Pharmacodynamic (PD) Analysis Set - Participants receiving study medication who completed protocol procedures without serious violation of the protocol were eligible for PD analysis. All 10 subjects from Cohort 1 were included. Three subjects in Cohort 2 were excluded from the PD analysis set, which therefore consisted of 7 subjects.|||percentage of time||Standard Deviation|Mean
1333650|NCT02037425|Other Pre-specified|Neuronal Regrowth|Compare neuronal regrowth in the skin biopsies with duration of benefit of onabotulinumtoxinA in Groups A, B, C from baseline to 12 weeks post randomization. Neuronal regrowth change was scored on a 0-3 point scale with 0 being no change from baseline in regrowth and 3 being significant change from baseline.|Baseline & Week 12 Post Randomization|Only a subset of subjects (n = 14) completed this endpoint for the trial based on the protocol design.|||units on a scale||Standard Deviation|Mean
1333651|NCT02037425|Secondary|Duration of onabotulinumtoxinA Over 3 Injection Cycles|Compare duration of benefit of onabotulinumtoxinA response through 3 injection cycles as measured by headache days per week (including the last 4 weeks of every injection cycle). A percent of responders was calculated using a 30% reduction of the number of headache days compared to average number of headache per week during baseline.|Weeks 9, 10, 11, 12, 21, 22, 23, 24, 33, 34, 35, 36 Post Randomization||||percentage of responders|||Number
1333652|NCT02037425|Secondary|Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles|Compare the consistency of duration of onabotulinumtoxinA response by the group assignment at 12 weeks to assessments at 24, and 36 weeks evaluations as measured by the number of responders. A responder is defined as a 30% reduction from baseline in the number of headache days.|Weeks 12, 24, and 36 Post Randomization||||participants|||Number
1333653|NCT02037425|Secondary|Acute Medication Usage|Comparison of acute medication usage between Groups A, B, and C during baseline, Treatment Period 1, 2, and 3.|From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days||||number of medications used||Standard Deviation|Mean
1333654|NCT02037425|Secondary|Sleep Quality Question|Comparison between Group A, B, and C for sleep quality scores measured at baseline and weeks 12, 24, and 36 post-randomization. A single sleep quality question was asked indicating quality of sleep over the past four weeks. The scale ranged from 1-5, with 1 being very poor quality and 5 being very good quality of sleep.|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
1333655|NCT02037425|Secondary|State-Trait Anxiety Inventory (STAI)|Comparison between Group A, B, and C for STAI scores measured at baseline and weeks 12, 24, and 36. Scores range from 20-80, with 20 indicating lower levels of anxiety most generally, and 80 indicating higher levels of anxiety most generally.|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
1333656|NCT02037425|Secondary|Beck Depression Inventory II (BDI-II)|Comparison between Group A, B, and C for BDI-II scores measured at baseline and weeks 12, 24, and 36. A total score of 0-10 = these ups and downs are considered normal, 11-16 = mild mood disturbance,17-20 = borderline clinical depression, 21-30 = moderate depression, 31-40 = severe depression, over 40 = extreme depression|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
1333657|NCT02037425|Secondary|Physician Global Impression of Change (PGIC)|Comparison between Group A, B, and C for PGIC scores measured at weeks 12, 24, and 36. the PGIC scale scores range from 0-7 with 0 being Very Much Worse and 7 being Very Much Improved. A higher score indicates a greater impression of change.|Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
1333658|NCT02037425|Secondary|Social Readjustment Rating Scale (SRRS)|Comparison between Group A, B, and C for SRRS scores (impact of common stressors) measured at baseline and weeks 12, 24, and 36. Scores can range from 0 to an undetermined amount, as subjects are allowed to rate unlisted events according to their own sense of stress. A total lower than 150 suggests a low level of stress and a low probability of developing a stress-related disorder. Scores greater than 150 suggest higher levels of stress and higher probabilities of developing stress-related disorders.|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
1333659|NCT02037425|Secondary|Migraine Disability Assessment Scale (MIDAS)|"Comparison between Group A, B, and C for MIDAS total scores (effect migraine headaches have on subjects daily function) measured at baseline and weeks 12, 24, and 36.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
1333660|NCT02037425|Secondary|Headache Days|Comparison of headache days per month over each injection cycle between Groups A, B, and C (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Subjects will remain in their assigned groups based on assessment at 12 weeks.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days||||number of headache days||Standard Deviation|Mean
1333661|NCT02037425|Primary|Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C|Compare the duration of onabotulinumtoxinA response through the 3 injection cycles of the study for Groups A, B, and C as measured by headache days during each period (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Duration of response is defined as a 30% reduction in the number of headache days compared to baseline.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days||||percentage of responders|||Number
1333662|NCT02037425|Primary|Subject Global Impression of Change|Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C. Subject global impression of change was measured on a 7 point scale with 0 being Very Much Worse and 7 Very Much Improved.|Weeks 12, 24, and 36 Post Randomization|Subjects included in this outcome measure analysis include those completing treatment period 1 injection cycle and returning at visit 3.|||units on a scale||Standard Deviation|Mean
1333663|NCT02037347|Secondary|Time-to-cessation of Epidermal Necrosis||The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days||||days|||Number
1333664|NCT02037347|Secondary|Time-to-mucosal Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days|Adverse event experienced by participant precluded measuring this outcome.||||||
1333665|NCT02037347|Primary|Time-to-cutaneous Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days||||days|||Number
1333666|NCT02036840|Primary|Number of Subjects With Antibiotic Related Adverse Event||24 hours||||participants|||Number
1333667|NCT02036775|Secondary|Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss|Plateau time during which concentration of the analyte in plasma exceeds 75% of Cmax ss (T(C>75% Cmax ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||hours||Full Range|Median
1333668|NCT02036775|Secondary|Time Period When Concentration of the Analyte Exceeds Cav ss|Time period when the concentration of the analyte exceeds Cav ss (T (C>Cav ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||hours||Full Range|Median
1333669|NCT02036775|Secondary|Peak-trough Swing|Peak-trough swing (PTS) calculated as ((Cmax,ss - Cmin,ss / Cav,ss)*100)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||percentage of ng/mL||Standard Deviation|Mean
1333670|NCT02036775|Secondary|Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma|Peak-trough fluctuation between minimum and maximum concentration of the analyte in plasma (PTF)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng/mL||Standard Deviation|Mean
1333671|NCT02036775|Secondary|Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State|Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax ss). For Lasolvan 30mg and Lasolvan 60mg, tmax ss was determined as tmax ss 0-12 and tmax ss 12-24.|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||hours||Full Range|Median
1333672|NCT02036775|Secondary|Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State|Average concentration of the analyte in plasma in the time interval of 0 to 24 h at steady state (Cav ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333673|NCT02036775|Secondary|Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval|Steady state concentration of the analyte in plasma at the end of dosing interval (Cmin ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333674|NCT02036775|Secondary|Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)|Metric which characterises the rate of absorption at steady state (Cmax ss/AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||1/h||Geometric Coefficient of Variation|Geometric Mean
1333997|NCT02030535|Secondary|Peak RR Change From Patient Baseline Over All Post-dose Time Points|Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333675|NCT02036775|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg|Area under the concentration-time curve of the analyte in plasma at steady state during 0-24 h, adjusted to a daily dose of 60 mg (AUCss 0-24 norm)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333676|NCT02036775|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State|Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1333677|NCT02036775|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|Pharmacokinetic (PK) set relative bioavailability set (PK-BA set) which includes all subjects in the treated set who completed 3 periods and for whom the PK profiles in 3 periods could be adequately characterized in respect to at least 1 of the PK parameters of primary interest without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1333678|NCT02036580|Secondary|Immunogenecity|The incidence rate of positive serum antibodies to tralokinumab will be reported.|From baseline to Week 48|Safety population|||Patients|||Number
1333679|NCT02036580|Secondary|Serum Tralokinumab Concentration Data|Serum tralokinumab concentration data will be summarized by treatment group.|From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48)|PK population|||Microgram per milliliter||Standard Deviation|Mean
1333680|NCT02036580|Primary|Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events|Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.|From baseline to Week 48 (treatment-emergent only)|Safety population|||Patients|||Number
1333681|NCT02036541|Primary|Mean Change in IOP From Baseline|Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.|12 Months|All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.|||mmHg||Standard Deviation|Mean
1333682|NCT02036541|Primary|Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications|Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.|12 Months|All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.|||Participants|||Count of Participants
1333683|NCT02036515|Secondary|Change From Baseline in EQ-5D-3L Score at Week 52|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy."|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).|||Score on a scale||95% Confidence Interval|Least Squares Mean
1333684|NCT02036515|Secondary|Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy."|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).|||Score on a scale||95% Confidence Interval|Least Squares Mean
1333685|NCT02036515|Secondary|Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ visual analogue score (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best)."|Baseline|Analysis population included all randomized participants who took at least one dose of study medication and had a baseline EQ-5D-3L measurement.|||Score on a scale||Standard Deviation|Mean
1333686|NCT02036515|Secondary|Change From Baseline in HOMA-%β at Week 52|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).|||Percentage||95% Confidence Interval|Least Squares Mean
1333687|NCT02036515|Secondary|Change From Baseline in HOMA-%β at Week 26|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).|||Percentage||95% Confidence Interval|Least Squares Mean
1333688|NCT02036515|Secondary|Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]|Baseline|Analysis population included all randomized participants who took at least one dose of study medication and had HOMA-%β measurement at baseline.|||Percentage||Standard Deviation|Mean
1333689|NCT02036515|Secondary|Time to Initiation of Glycemic Rescue by Week 52|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days.|Up to week 52|Analysis population included all randomized participants who took at least one dose of trial treatment.|||Days|||Number
1333690|NCT02036515|Secondary|Time to Initiation of Glycemic Rescue by Week 26|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days. Below data include data from 1 participant in the Placebo arm who continued Phase A treatment for an additional 30 days.|Up to Week 26 (plus 30 days for 1 placebo participant)|Analysis population included all randomized participants who took at least one dose of trial treatment|||Days|||Number
1333691|NCT02036515|Secondary|Percentage of Participants Receiving Glycemic Rescue Medication by Week 52|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).|Week 52|Analysis population included all randomized participants who took at least one dose of trial treatment.|||Percentage of participants|||Number
1333692|NCT02036515|Secondary|Percentage of Participants Receiving Glycemic Rescue Medication by Week 26|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).|Week 26|Analysis population included all randomized participants who took at least one dose of trial treatment.|||Percentage of participants|||Number
1333693|NCT02036515|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 52|The change from baseline is the Week 52 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
1333694|NCT02036515|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26|The change from baseline is the Week 26 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
1333695|NCT02036515|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 52|The change from baseline is the Week 52 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
1333696|NCT02036515|Secondary|Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percentage of participants|||Number
1333697|NCT02036515|Secondary|Change From Baseline in Body Weight at Week 52|The change from baseline is the Week 52 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).|||kg||95% Confidence Interval|Least Squares Mean
1333698|NCT02036515|Secondary|Change From Baseline in FPG at Week 52|The change from baseline is the Week 52 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
1333699|NCT02036515|Secondary|Change From Baseline in Hemoglobin A1C at Week 52|A1C is measured as percent. Thus this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
1333700|NCT02036515|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26|The change from baseline is the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
1333701|NCT02036515|Secondary|Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percentage of participants|||Number
1333702|NCT02036515|Secondary|Change From Baseline in Body Weight at Week 26|The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).|||kg||95% Confidence Interval|Least Squares Mean
1333703|NCT02036515|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
1333704|NCT02036515|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to Week 52|Analysis population consisted of all randomized participants who took at least one dose of study medication.|||Percentage of participants|||Number
1333705|NCT02036515|Primary|Percentage of Participants Experiencing An Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to Week 54|Analysis population consisted of all randomized participants who took at least one dose of study medication.|||Percentage of participants|||Number
1333706|NCT02036515|Primary|Change From Baseline in Hemoglobin A1C at Week 26|A1C is measured as percent. Thus this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
1333707|NCT02036424|Primary|Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven|Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.|baseline to month seven||||microns|Participants|Standard Deviation|Mean
1333708|NCT02036424|Primary|Mean Visual Acuity Change|Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.|baseline to month 7||||ETDRS letters|Participants|Standard Deviation|Mean
1333709|NCT02036320|Primary|"Lens Does Not Exhibit Hula Hoop Effect"|"The number of subjects that did not exhibit a hula hoop effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp."|15 mins post insertion|The analysis population consists of subjects that completed all study visits, without a major protocol deviation|||Subject|||Number
1333710|NCT02036320|Primary|Cosmetic Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Eyes|Eyes||Number
1333711|NCT02036320|Primary|Mechanical Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Eyes|Eyes||Number
1333712|NCT02035748|Secondary|Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)|Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 180|Full Analysis Set. Missing data is imputed using LOCF. CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.|||micrometers||Standard Deviation|Mean
1333713|NCT02035748|Secondary|Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180|Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.|Day 180|Full Analysis Set|||percentage of subjects|||Number
1333714|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis.|Baseline, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after the timepoint of vitrectomy.|||percentage of subjects|||Number
1333715|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline|The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis.|Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after MH closure were considered as 'no MH closure' after the timepoint of vitrectomy.|||percentage of subjects|||Number
1333716|NCT02035748|Secondary|Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance|BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. BCVA values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.|||letters||Standard Deviation|Mean
1333717|NCT02035748|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD‐OCT) Evaluation|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.|Baseline, Day 28|This analysis population includes all subjects who received treatment with IP and had at least one post-treatment measurement of SD-OCT (FAS). Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after timepoint of vitrectomy.|||percentage of subjects|||Number
1333718|NCT02035696|Secondary|Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine|Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)|Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209|Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data|||Subjects|||Number
1333719|NCT02035696|Secondary|Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine|Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)|Day 1 to Day 7|Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h –day3, day4-day7 and 6h – day 7) as these subjects did not provide any post vaccination solicited safety data|||Subjects|||Number
1333720|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI"|Day 1 and Day 50 post vaccination|Analysis was done on PPS|||Percentages of subjects||95% Confidence Interval|Number
1333721|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI"|Day 1 and Day 50 post vaccination|Analysis was done on PPS|||Percentage of subjects||95% Confidence Interval|Number
1333722|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 1 and Day 50 post vaccination|Analysis was done on PPS|||Percentages of subjects||95% Confidence Interval|Number
1333725|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%~The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70%"|Day 1, Day 50 post vaccination|Analysis was done on FAS|||Percentages of subjects||95% Confidence Interval|Number
1333726|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer~The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%~The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40%"|Day 50 post vaccination|Analysis was done on Full analysis set|||Percentages of subjects||95% Confidence Interval|Number
1333727|NCT02035696|Primary|Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine|Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.|Day 1 to Day 3|Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points).|||percentage of participants|||Number
1333728|NCT02035696|Primary|Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer|Day 50 post vaccination|Analysis was done on PP population|||Percentages of subjects||95% Confidence Interval|Number
1333729|NCT02035696|Primary|Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 50/Day 1|Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis|||Ratios||95% Confidence Interval|Number
1333730|NCT02035553|Primary|Antipsychotic Efficacy|Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions [Domain A]+Hallucinations [Domain B]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.|Day 43|All randomized subjects who received at least one dose of study treatment and have both a Baseline and at least one post-Baseline NPI-NH psychosis score evaluation.|||Score on the NPI-NH scale||95% Confidence Interval|Least Squares Mean
1333731|NCT02035475|Secondary|Surgical Complications|Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include “no complications” (0), “minor complications” (1), and “major complications” (2).|4 months||||participants|||Number
1333732|NCT02035475|Primary|Incidence of Lymphoceles|Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis.|4 months|Lymphoceles were identified by CT scan at 3 months post surgery.|||participants|||Number
1333733|NCT02035345|Primary|Number of Patients With Carboplatin Reactions of Different Severity|To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.|2 Years|Among the 15 patients enrolled, the HSR rate was 40% which occurred after a median of 2 protocol treatments, which prompted early termination of this study.|||participants|||Number
1333734|NCT02035345|Primary|Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program|To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program|2 Years|Total number of patients in the study that received carboplatin via slowed infusion.|||participants|||Number
1333735|NCT02035332|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat|||participants|||Number
1333736|NCT02035332|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.|Day of procedure|Subjects completing treatment|||Minutes||Standard Deviation|Mean
1334062|NCT02029521|Secondary|Vitamin E|Serum Vitamin E levels were measured to determine if treatment affected this test.|6 months|All participants.|||milligrams per liter||Standard Deviation|Mean
1333737|NCT02035332|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12-months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75. A score of 0 represents no bleeding.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)|||participants|||Number
1333738|NCT02034916|Other Pre-specified|Time to Deterioration in Disease Specific Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)|Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the symptom score based on the EORTC-QLQ-BR23, whichever occurred first. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much) within each scale.|Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
1333739|NCT02034916|Other Pre-specified|Time to Deterioration in Global Health Status/Quality of Life (QOL) and Functional Status as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the functional status score and global health status/QOL score based on the EORTC-QLQ-C30, whichever occurred first. EORTC-QLQ-C30 questionnaire is a standardized instrument developed to assess the quality of life of people with cancer. EORTC-QLQ-C30 functional subscale includes 5 items: physical, role, emotional, cognitive, and social functioning. All of the single items of functional status subscale measures and global health status/QOL subscale range from 0 to 100, where higher scores represent a better level of functioning/quality of life.|Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
1333740|NCT02034916|Secondary|Trough Concentration Versus Time Summary of Talazoparib|Concentrations below the limit of quantitation values less than or equal to (<=) 25 picogram per milliliter (pg/mL) were set as zero. Pharmacokinetic (PK) analysis was not done separately for each reporting arm and cohorts were combined for PK analysis.|Predose on Day 1 of Cycle 1, 2, 3 and 4|PK population included all participants who received at least 1 dose of talazoparib and had evaluable PK assessments.|||pg/mL||Standard Deviation|Mean
1333741|NCT02034916|Secondary|Number of Participants With Atleast 1 Concomitant Medication|Number of participants taking any non-study medications, therapies, including herbal supplements during the treatment-emergent period for the management of an adverse event or for the treatment of any other disease.|From first dose of study drug up to 30 days after the last dose or before initiation of a new anticancer treatment, whichever occurred first (up to the data cutoff date [01 Sep 2016])|Safety population included all participants who received at least 1 dose of talazoparib.|||participants|||Number
1333742|NCT02034916|Secondary|Number of Participants With Clinically Significant Change From Baseline in Physical Findings|Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator’s decision.|Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||participants|||Number
1333743|NCT02034916|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria for clinically significant vital sign changes: 1) Blood pressure: systolic blood pressure (SBP): >=30 millimeters of mercury (mmHg) increase from baseline, diastolic blood pressure (DBP): >=20 mmHg decrease from baseline; 2) Heart rate (HR): absolute HR > 120 beats per minute (bpm) and >30 bpm increase from baseline, absolute HR <50 bpm and >20 bpm decrease from baseline; 3) Weight: >10% decrease from baseline. Number of participants with any clinically significant change in abnormalities for blood pressure, heart rate and weight are reported in this outcome measure.|Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])|Safety population included all participants who received at least 1 dose of talazoparib.|||participants|||Number
1333744|NCT02034916|Secondary|Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameters|Laboratory tests included hematology (hemoglobin [low], leucocytes [low], lymphocytes [low], neutrophils [low], platelets [low]) and serum chemistry (alanine aminotransferase [high], albumin [low], alkaline phosphatase [high], aspartate aminotransferase [high], bilirubin [high], calcium [low], glucose [high], magnesium [low], phosphate [low], potassium [high], potassium [low], sodium [high], sodium [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for hematology and chemistry laboratory parameters is reported in this outcome measure.|Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])|Safety population included all participants who received at least 1 dose of talazoparib.|||participants|||Number
1333805|NCT02034162|Primary|Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1333745|NCT02034916|Secondary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: ‘Is the AE leading to study discontinuation or death?’ as ‘yes’.|Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])|Safety population included all participants who received at least 1 dose of talazoparib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.|||participants|||Number
1333746|NCT02034916|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A treatment-related SAE was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria.|Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])|Safety population included all participants who received at least 1 dose of talazoparib. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.|||participants|||Number
1333747|NCT02034916|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria . A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])|Safety population included all participants who received at least 1 dose of talazoparib.|||participants|||Number
1333748|NCT02034916|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of study drug to death due to any cause. For participants without a death date at the time of data cutoff or permanently lost to follow-up, OS was right-censored at the date the participant was last known to be alive on or before the data cutoff date.|From first dose of study drug until death due to any cause (up to the data cutoff date [01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
1333749|NCT02034916|Secondary|Progression Free Survival (PFS)|PFS was defined as the time in months from the first dose of study drug to the first documentation of PD by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PFS event at the analysis were censored at last tumor assessment date prior to data cutoff or date of new anticancer treatment initiation, whichever occurred first.|From first dose of study drug until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
1333750|NCT02034916|Secondary|Duration of Response (DOR)|DOR: Time from first documentation of CR or PR, to PD by IRF assessment using RECIST 1.1, or to death due to any cause, whichever occurred first. CR: Disappearance of all non-nodal target and non-target lesions, with target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PD or death at the analysis date were censored at last tumor assessment date prior to on or before initiation of a new anticancer therapy or before the data cutoff date.|From first documentation of CR or PR until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])|TEP included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan + 1 week window. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1333751|NCT02034916|Secondary|Clinical Benefit Rate-24 (CBR-24)|CBR24: Percentage of participants with a best response of CR, PR or stable disease (SD) sustained for at least 24 weeks, as assessed by IRF using RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. SD: Neither PR nor progression of disease (PD) criteria met. SD follow PR only when sum increases by less than 20% from the nadir, but previously seen 30% decrease from baseline no longer hold. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions.|From randomization until data cutoff date (01 Sep 2016)|TEP included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan + 1 week window.|||percentage of participants||95% Confidence Interval|Number
1333752|NCT02034916|Primary|Objective Response Rate (ORR)|ORR: Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1). CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to less than (<) 10 millimeter (mm) in short axis. PR: Greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions, compared to the sum at baseline. Response evaluation was done by an independent radiology facility (IRF).|From randomization until data cutoff date (01 Sep 2016)|Tumor-evaluable population (TEP) included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan plus (+) 1 week window.|||percentage of participants||95% Confidence Interval|Number
1333753|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Percentage of participants||95% Confidence Interval|Number
1333754|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Percentage of participants||95% Confidence Interval|Number
1333755|NCT02034877|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination|GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination, 1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Fold rise||95% Confidence Interval|Geometric Mean
1333756|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Titers||95% Confidence Interval|Geometric Mean
1333757|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Titers||95% Confidence Interval|Geometric Mean
1334063|NCT02029521|Secondary|White Blood Cell Count|White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.|6 months|All participants.|||1000 cells/mm^3||Standard Deviation|Mean
1333758|NCT02034877|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Within 1 month after 13vPnC vaccination|Safety population included all participants who received 1 dose of 13vPnC vaccination.|||Percentage of participants|||Number
1333759|NCT02034799|Secondary|Incidence of Potential Bleeding-related Adverse Events||Through 30-day follow-up||||participants|||Number
1333760|NCT02034799|Secondary|Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.||Through 30-day follow-up||||participants|||Number
1333761|NCT02034799|Secondary|Hemostasis at the TBS at 3 Minutes Following Treatment Application|The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS.|Intra-operative, 3 minutes following randomization||||% of participants||95% Confidence Interval|Number
1333762|NCT02034799|Primary|Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.|The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.|Intra-operative, 6 minutes following randomization||||% of participants||95% Confidence Interval|Number
1333763|NCT02034708|Primary|Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent|"Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale:~0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion."|Up to 15 days after randomization|Patients with at least one valid assessment of the primary outcome and without major protocol deviation|||percentage of patients|||Number
1333764|NCT02034591|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes >1.2* upper limits of normal (ULN) , Basophils >3%, Eosinophils >1.5*ULN, Blood Urine >=2, Red Blood Cell (RBC) Urine >=2, White Blood Cell (WBC) Urine >=2|Day 1 to 30 days after last dose of study drug|All randomized participants|||participants|||Number
1333765|NCT02034591|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0|Day 1 to 30 days after last dose of study drug|All randomized participants|||participants|||Number
1333766|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333767|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333768|NCT02034591|Secondary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng/mL||90% Confidence Interval|Geometric Mean
1333769|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333770|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333771|NCT02034591|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available pharmacokinetic (PK) data|||ng/mL||90% Confidence Interval|Geometric Mean
1333998|NCT02030535|Secondary|Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333772|NCT02034578|Secondary|Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests|Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX.|Screening, Day -1, Day 4 of Periods, 1, 2, and 3|Participants who received study drug were analyzed.|||participants|||Number
1333773|NCT02034578|Secondary|Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings|12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge.|Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3|All participants who received study drug were analyzed.|||participants|||Number
1333774|NCT02034578|Secondary|Mean Plasma Elimination Half-Life (T-HALF) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||h||Standard Deviation|Mean
1333775|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL.|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333776|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333777|NCT02034578|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. Maximum observed plasma concentration (Tmax) was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3||||h||Full Range|Median
1333778|NCT02034578|Primary|Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||ng/mL||90% Confidence Interval|Geometric Mean
1333779|NCT02034578|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 12|All participants who received study drug were analyzed.|||participants|||Number
1333780|NCT02034565|Secondary|Number of Participants With Marked Laboratory Abnormalities|Clinical laboratory tests were performed pre-study and at selected times throughout the study. Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes < 0.9* lower limits of normal (LLN), absolute neutrophils + bands <= 1.500 10*3 cells/microliter, white blood cells (WBC) urine value >= 2+. These laboratory abnormalities were not considered clinically significant and therefore not adverse events.|Pre-study screen (Day -1) to Day 8 or day of study discharge|All treated participants|||participants|||Number
1333806|NCT02034162|Primary|Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The intent-to-treat (ITT) analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1334190|NCT02027311|Secondary|Event of Hypoxia|Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%|Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase||||Hypoxia events|||Number
1333781|NCT02034565|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related Adverse Events (AEs), Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v13).|Day 1 to 30 days after last dose of study drug|All treated participants|||participants|||Number
1333782|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333783|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data|||ng*h/mL||90% Confidence Interval|Geometric Mean
1333784|NCT02034565|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pharmacokinetic (pk) data|||ng/mL||90% Confidence Interval|Geometric Mean
1333785|NCT02034552|Secondary|Overall Survival (OS)||From randomization to the date of radiological disease progression, up to 7.5 years|Data were not collected and are anticipated to be reported in November, 2018.||||||
1333786|NCT02034552|Secondary|Time to First Symptomatic Skeletal Event (SSE)||From randomization to first SSE or death, up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.||||||
1333787|NCT02034552|Secondary|Symptomatic Skeletal Event-free Survival (SSE-FS)||From randomization to the earlier SSE or death, up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.||||||
1333788|NCT02034552|Secondary|Time to Radiological Bone Progression by Treatment Group||From randomization to radiological bone progression up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.||||||
1333789|NCT02034552|Secondary|Radiological Progression-free Survival (rPFS)||From randomization to radiological disease progression or death from any cause, up to 30 months|Data were not collected and are anticipated to be reported in November, 2018.||||||
1333790|NCT02034552|Primary|Patient Bone Scan Response Rate|Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software. Responder (R): 30% or greater resolution of the BSLA compared to baseline. Stable Disease (SD): Not meeting the criteria for R, PD, or UE. Progressive Disease (PD): Two or more new areas of radiotracer uptake attributable to metastatic disease in regions of bone that had not previously shown radiotracer uptake or greater than 30% increase from baseline in BSLA attributable to metastatic disease. Unable to Evaluate (UE): Assigned if bone scan results cannot be interpreted due to inconsistent image acquisition parameters compared to the reference scan, incomplete imaging, or other similar technical deficiencies.|At 24 weeks|Imaging endpt analysis set (IMG): consists of mITT subj. (ITT subj. who received at least one dose of each study drug as randomized) with evaluable imaging scan at baseline, eg. bl quantitated technetium-99 bone scan imaging of sufficient completeness and quality to be assessable and having a non-zero BSLA, as determ. by the central reviewer.|||Percentage|||Number
1333791|NCT02034513|Secondary|FPG (Fasting Plasma Glucose)|Fasting plasma glucose values at week 32 and week 64.|Week 32 and Week 64|Results are based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.|||mmol/L||Standard Deviation|Mean
1333792|NCT02034513|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64.|Week 32, Week 64|Both descriptive analysis and statistical analysis were based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1333793|NCT02034513|Secondary|Incidence of Treatment Emergent Adverse Events|Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|During 32 weeks of treatment for each treatment period|The trial followed a cross over design. Results are based on the SAS.|||Event|||Number
1333794|NCT02034513|Secondary|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period|Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.|||Percentage of subjects|||Number
1333999|NCT02030535|Secondary|Heart Rate Change From Patient Baseline at Individual Post-dose Time Points|Heart rate change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||bpm||Standard Deviation|Mean
1333795|NCT02034513|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period|Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.|||Event|||Number
1333796|NCT02034513|Primary|Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).|A 16-week treatment period.|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (SAS: subjects receiving at least 1 dose of the investigational product, IDeg or its comparator, IGlar). Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.|||Event|||Number
1333797|NCT02034162|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole|The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||ng*h/mL||Standard Deviation|Mean
1333798|NCT02034162|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole|The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||nanogram hour per Milliliters(ng*h/mL)||Standard Deviation|Mean
1333799|NCT02034162|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole|The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||hours||Full Range|Mean
1333800|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)|The open-label follow-up safety analysis set consisted of all randomized participants who received a 500-mg chewable tablet of mebendazole at Visit 3. Here 'N' signifies number of participants analysed for this outcome measure.|||participants|||Number
1333801|NCT02034162|Secondary|Maximum Plasma Concentration (Cmax) of Mebendazole|The Cmax is the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|Pharmacokinetic (PK) population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
1333802|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percent change in egg count|||Number
1333803|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percent change in egg count|||Number
1333804|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Visit 3 (Day 19 +/-2)|The safety analysis set consisted of all randomized participants who received 1 dose of study agent (mebendazole or placebo) at baseline. Here 'N' signifies number of participants analysed for this outcome measure.|||participants|||Number
1334071|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age|3 months|BMI percentile not available for children under 2 years of age.|||Percentile adjusted for age and sex||Standard Deviation|Mean
1333808|NCT02033499|Secondary|Baseline Health Care Utilization and at 52 Weeks|Primary care visits, hospitalization, urgent care, and emergency room and emergency medical service (EMS) visits recorded at baseline and 52 weeks.|Baseline and 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able provide this information, yet did provide blood samples for A1c testing and vice versa.|||number of events||Standard Deviation|Mean
1333809|NCT02033499|Secondary|Hypoglycemia Frequency|Number of participants with hypoglycemia events for the 52 week intervention period.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to provide information for this measure, yet did provide blood samples for A1c testing and vice versa.|||Participants|||Count of Participants
1333810|NCT02033499|Secondary|Change in Patient-Provider Communication From Baseline to 52 Weeks|Change from baseline patient perception of communication with their provider at 52 weeks using the Communication Assessment Tool (CAT). Scale scores range from 1 to 5, with 5 being the best communication.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
1333811|NCT02033499|Secondary|Change Diabetes Empowerment Scale - Short Form (DES-SF) From Baseline to 52 Weeks|Changes in diabetes-specific self-efficacy using the Diabetes Empowerment Scale - Short Form from baseline at 52 weeks. The scale ranges from 1 to 5, with 5 indicating most empowered.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing.|||units on a scale||Standard Deviation|Mean
1333812|NCT02033499|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire Subscale Scores From Baseline to 52 Weeks|Change from baseline patient satisfaction with treatment at 52 weeks using the Diabetes Treatment Satisfaction Questionnaire subscales, overall satisfaction and satisfaction with blood glucose control. For overall satisfaction, the range is 0-36, with 36 (high score) being the most satisfied. For satisfaction with blood glucose control, the subscale range is 0 to 12, with 0 (low score) indicating the most satisfaction.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing.|||units on a scale||Standard Deviation|Mean
1333813|NCT02033499|Secondary|Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks|Change in the SDCA subscales (general diet, specific diet, exercise, blood sugar testing, and foot care), a multidimensional measure of diabetes self-management activities, from baseline at 52 weeks will be assessed. For each subscale, the score is the mean number of days specified subscale activities occurred. Each subscale ranges from 0 to 7, with 7 the best score possible.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
1333814|NCT02033499|Secondary|Change in Diabetes Symptom Checklist- Revised (DSC-R) Overall Score From Baseline to 52 Weeks|Change in diabetes-related symptom frequency and perceived severity from baseline at 52 weeks using the Diabetes Symptom Checklist-Revised. Overall score ranges from 0 to 170, with 170 indicating the worse symptom severity.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
1333815|NCT02033499|Secondary|Change in Problem Areas in Diabetes Scores From Baseline to 52 Weeks|The change from baseline Problem Areas in Diabetes (PAID) scores will be assessed at 52 weeks. The PAID is a widely used tool to assess psychological and social stress associated with diabetes. The PAID scores range from 0 to 100, with 100 indicating the most distress.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
1333816|NCT02033499|Primary|Mean Difference in Health-related Quality of Life Scores From Baseline to 52 Weeks|Change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life. Each subscale score ranges from 0 – 100, with 100 being the best quality of life score.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete the SF-36, yet did provide blood samples for A1c testing.|||Units on a scale||Standard Deviation|Mean
1333817|NCT02033499|Primary|Absolute Change in % Hemoglobin A1c From Baseline at 52 Weeks|Absolute Change in Glycemic Control (% Hemoglobin A1c) from baseline at 52 weeks|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to provide blood samples yet were able to complete all or part of the patient interview.|||Percent Hemoglobin A1c||Standard Deviation|Mean
1333818|NCT02033369|Secondary|Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale|"A validated self-rated scale shown to assess consummatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108."|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
1333819|NCT02033369|Secondary|Change in Clinical Global Improvement - Severity Scale|Seven-point Likert scale rating clinical severity of mental illness from 1 (least severe) to 7 ( most severe). Physician-rated scale. One item.|6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
1333820|NCT02033369|Secondary|Change in the Apathy Evaluation Rating Scale|A validated self-rated 18 item scale assessing apathy. Items were rated from 1 (not at all true) to 4 (very true). Higher scores indicate lower apathy, lower scores indicate higher apathy. Lowest possible score is 18, highest possible score is 72.|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
1333821|NCT02033369|Secondary|Change in Mood and Anxiety Symptom Questionnaire, Short Form|Change in Mood and Anxiety Symptom Questionnaire, Short Form. A 62-item scale assessing anxiety and depression. Items were measured on a scale of 1-5, higher number indicating higher levels of symptoms.The lowest possible score was 62, and the highest 310.|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
1333822|NCT02033369|Secondary|Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale|"A validated self-rated scale shown to assess anticipatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108."|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
1333823|NCT02033369|Secondary|Change in Snaith Hamilton Pleasure Scale|"Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as strongly disagree (1), disagree (2), agree (3), or strongly agree (4). The lowest possible score was 14, the highest possible score was 56."|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
1333824|NCT02033369|Primary|Change in Hamilton Rating Scale for Depression|Hamilton Rating Scale for Depression (HRSD), 17-item version. This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 6, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression)|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
1333825|NCT02033317|Primary|Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)||Day -7 Through Day -1 and Day 1 Through Day 7||||mg/Day||Standard Deviation|Mean
1333826|NCT02033317|Primary|Change in Serum Potassium (Day 1 to Day 8)||Day 1 and Day 8||||mmol/L||Standard Deviation|Mean
1333827|NCT02033213|Secondary|Total Volume of Administered Intraoperative Fluid|Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.|End of surgery||||milliliters||Standard Deviation|Mean
1333828|NCT02033213|Secondary|Duration of Surgery|Total time of Lewis-Tanner procedure will be measured and compared between two groups.|End of surgery.||||minutes||Standard Deviation|Mean
1333829|NCT02033213|Primary|Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).|10 minutes, 6 hours||||mmol/L||Standard Deviation|Mean
1333830|NCT02033213|Primary|Lactate Values During and After Esophageal Carcinoma Surgery|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.|10 minutes, 6 hours||||mmol/L||Standard Deviation|Mean
1333831|NCT02033213|Primary|Creatinine Values During and After Esophageal Carcinoma Surgery|At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.|10 minutes, 6 hours||||μmol/L||Standard Deviation|Mean
1333832|NCT02033213|Primary|Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)|At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.|10 minutes, 6 hours||||mmHg||Standard Deviation|Mean
1333833|NCT02033200|Secondary|Change From Baseline in Intraocular Pressure 24 Hour Post Dosing|Intraocular pressure was measuring using the Goldman applanation tonometry|24 hours||||mm Hg||Standard Deviation|Mean
1333834|NCT02033200|Secondary|Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing||24 hours||||total error score||Standard Deviation|Mean
1333835|NCT02033200|Secondary|Change From Baseline in Pupil Dilation 24 Hour Post Dosing||24 hour||||mm||Standard Deviation|Mean
1333836|NCT02033200|Secondary|Change From Baseline in Visual Acuity 24 Hours Post Dosing||24 hours||||LogMar||Standard Deviation|Mean
1333837|NCT02033200|Primary|Change From Baseline in Intraocular Pressure 1 Hour Post Dosing|Intraocular Pressure was measured using the Goldman applanation tonometry|1 hour||||mm Hg||Standard Deviation|Mean
1333838|NCT02033200|Primary|Change From Baseline in Pupil Dilation 1 Hour Post Dosing|Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.|1 hour||||millimeter||Standard Deviation|Mean
1333839|NCT02033200|Primary|Change From Baseline in Visual Acuity 1 Hour Post Dosing|Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read.|1 hour||||LogMar||Standard Deviation|Mean
1333840|NCT02033200|Primary|Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing|Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced.|1 hour||||total error score||Standard Deviation|Mean
1333841|NCT02033174|Primary|Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake|In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R&D Systems, Inc. Minneapolis, USA) was conducted.|Baseline and 5 days|All participants who completed all study visits were included|||percentage of change in TAC||Inter-Quartile Range|Median
1334064|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.|6 months|All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age|||Percentile adjusted for age and sex||Standard Deviation|Mean
1333842|NCT02032901|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Day 1 first dose to last dose plus 7 days|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Participants|||Number
1333843|NCT02032901|Primary|Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||percentage of participants||95% Confidence Interval|Number
1333844|NCT02032901|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, ''n'' signifies number of participants evaluable for the specified category.|||Percentage of participants||95% Confidence Interval|Number
1333845|NCT02032901|Secondary|Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.|Baseline, Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies the number of evaluable participants with or without cirrhosis in the reporting arm and time point, respectively.|||Percentage of participants||95% Confidence Interval|Number
1333846|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
1333847|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 6, 8 (treatment period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
1333848|NCT02032901|Secondary|Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)|EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Up to the end of treatment (up to 24 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||percentage of participants||95% Confidence Interval|Number
1333849|NCT02032901|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)|cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
1333850|NCT02032901|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)|RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
1333851|NCT02032901|Primary|Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
1333852|NCT02032888|Secondary|Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results|Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1–3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9–1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1–10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6–5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1–5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4.|From screening up to week 24 of post treatment follow­-up|All participants who received at least 1 dose of study drug|||Participants|||Number
1333853|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.|All participants who received at least 1 dose of study drug|||Participants|||Number
1333854|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)|All participants who received at least 1 dose of study drug.|||Participants|||Number
1333855|NCT02032888|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR is defined as hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.|At Follow-up Week 12|All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype.|||Percentage of participants||95% Confidence Interval|Number
1333856|NCT02032888|Secondary|Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants with HCV RNA levels <LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment|All participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1333857|NCT02032888|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24|Participants with hepatitis C virus CV) levels to be <lower limit of quantitation, TD or TND at each visit. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24|All participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1333858|NCT02032888|Secondary|Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA levels <lower limit of quantitation, target detected or target not detected. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1333859|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-experienced participants coinfeted with HCV/HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1333860|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA<lower limit of quantitation, target detected, or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-naive participants coinfected with genotype 1 HCV and HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1333861|NCT02032888|Primary|Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All genotype 1 treatment-naive participants who received at least 1 dose of study therapy. Here, 'number of participants analyzed' (N) signifies the number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1334016|NCT02029911|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat populations (all subjects in whom the experimental device was attempted to be placed)|||participants|||Number
1333862|NCT02032875|Secondary|Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities|Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50–7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9–50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1–3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9–1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109–0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1–10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6–5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1–5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9–3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4.|From start of study treatment up to 7 days post last dose of study treatment|All treated participants.|||participants|||Number
1333863|NCT02032875|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks)|All treated participants.|||participants|||Number
1333864|NCT02032875|Secondary|Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be <lower limit of quantitation ie, 25 IU/mL or below target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.|||Percentage of participants||95% Confidence Interval|Number
1333865|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit.|Week 1, 2, 4, 6, 8, 12, End of treatment|All treated participants.|||Percentage of participants||95% Confidence Interval|Number
1333866|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit.|Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24|All treated participants.|||Percentage of participants||95% Confidence Interval|Number
1333867|NCT02032875|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants who took at least 1 dose of study medication. Here, ‘n’ signifies participants evaluable for SVR12 at the specified time point in each group, respectively.|||Percentage of participants||95% Confidence Interval|Number
1333868|NCT02032875|Primary|Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All genotype 1 cirrhotic participants who received at least 1 dose of study therapy.|||Percentage of participants||95% Confidence Interval|Number
1333869|NCT02032875|Primary|Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All HCV genotype 1 infected post-transplant participants who received at least 1 dose of study therapy.|||Percentage of participants||95% Confidence Interval|Number
1333870|NCT02032758|Secondary|Mean Total Putter Face Rotation Before Impact|“Total putter face rotation before impact” is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.|||degrees||Standard Deviation|Mean
1334052|NCT02029521|Secondary|Frequency of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1333871|NCT02032758|Primary|Mean Dynamic Change of Rotation at Impact|“Dynamic change of rotation at impact” is the velocity of rotation of the putter from the start of the forward swing until the time of impact with the golf ball.|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.|||degrees/sec||Standard Deviation|Mean
1333872|NCT02032706|Secondary|Assess the Accuracy of Night Shift Measurement of Sleep Efficiency|Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device|one night|Studies included 35 baseline comparisons and 30 comparisons at follow-up|||% studies|||Number
1333873|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Measurement of Total Sleep Time|Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.|one night|Comparisons included 35 studies at baseline and 30 follow-up studies|||% of studies|||Number
1333874|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake|Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.|baseline and follow-up||||percentage of epochs||Standard Deviation|Mean
1333875|NCT02032706|Secondary|Evaluate Impact of Positional Therapy on Quality of Life Scores|Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate >2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.|four weeks||||Percentage of participants|||Number
1333876|NCT02032706|Secondary|Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA|The percentage of compliant participants who show an improved Epworth Sleepiness Score of >= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.|baseline and followup||||percentage of participants|||Number
1333877|NCT02032706|Secondary|Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback|Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use|four weeks||||% participants averaged < 15% supine|||Number
1333878|NCT02032706|Secondary|Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant|Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.|four weeks||||Percent of nights||Full Range|Median
1333879|NCT02032706|Secondary|Confirmation That Night Shift Accurately Detects Supine Position|Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).|baseline and 4-weeks later at follow up|35 subjects completed the baseline polysomnography (PSG) while wearing the device. One subject's PSG study was conducted prior to enrollment but qualified as a baseline. 30 subjects completed a follow-up PSG.|||percentage of participants|||Number
1333880|NCT02032706|Primary|Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy|Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.|30-days||||percentage of participants|||Number
1333881|NCT02032706|Primary|Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events|Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.|Four weeks||||Percentage of participants|||Number
1333882|NCT02032641|Secondary|Hair Loss|After each laser session, subjects were asked to rate perceived amount of hair loss from both the treated and control scars on a 1-10 scale, with 1 being none at all and 10 being extremely significant|within 1 hour after final treatment|Within 1 hour after treatment, subjects were given a mirror and asked to rate perceived hair loss for each side on a 1-10 scale, with 1 representing none and 10 representing very significant|||units on a scale|BROW|Standard Deviation|Mean
1333883|NCT02032641|Secondary|Overall Appearance|Subjects were asked to rate overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent, as rated by participant|10 minutes before first treatment and at the final visit|Patients were asked to grade overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent. Grading was done 10 minutes prior to each laser treatment and 4 weeks after final treatment|||units on a scale|BROW|Standard Deviation|Mean
1333884|NCT02032641|Primary|Relative Improvement|Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs|1 month after final treatment|3 graders masked to treatments were asked to judge side-by-side photographs of first and final visits for which scar improved more. Each pair of before-and-after photos was graded twice by each examiner. Results are percentage of times treated scar was chosen by examiners as most improved (an analysis of 6 results per pair of photos).|||percentage of times treated scar chosen|BROW|Standard Deviation|Mean
1333885|NCT02032433|Secondary|Opioid Abstinence Over Time While on Study Medication (Objective)|A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.|Weeks 0-24|Per protocol|||Weeks||Inter-Quartile Range|Median
1333886|NCT02032433|Secondary|Cognitive Function|Cognitive function was assessed via the Trails Making Test, Parts A and B, and the Stroop Color-Word Test. Both assessments were completed at baseline, every 4 weeks through the end of treatment/week 24.|Weeks 0-24|||||||
1333887|NCT02032433|Secondary|HIV Risk Behavior Over Time|HIV and other risk behaviors are assessed via the Risk Assessment Battery (RAB), assessed at baseline, week 12, end of treatment/ week 24 and at each follow up visit.|Weeks 0-36|||||||
1333889|NCT02032433|Secondary|Subacute Withdrawal Symptoms Over Time|Subacute withdrawal symptoms were assessed via the Subjective Opioid Withdrawal Scale, completed at baseline, before and after induction onto study medication, then weekly for the first 4 weeks, every 4 weeks for weeks 8-24 and at both follow up visits. The Hamilton Depression Scale (HAM-D, 17-item) was completed at screening, weekly for the first 4 weeks and then every four weeks and at both followup visits.|Weeks 0-36|||||||
1333890|NCT02032433|Secondary|Opioid Craving Over Time|Opioid craving was assessed via a Visual Analog Scale (VAS), completed at screening, weekly during treatment, and at each follow up visit.|Weeks 0-36|||||||
1333891|NCT02032433|Secondary|Cigarette Smoking|Cigarette smoking, tobacco use and craving were assessed via the Fagerstrom Test for Nicotine Dependence (FTND) and the Tobacco Use Questionnaire (part of PhenX) at baseline. Craving was assessed via a Visual Analog Scale (VAS), done at screening, every 4 weeks, and at each follow up visit. Number of cigarettes smoked per day was asked at screening, every 4 weeks, and at each follow up visit.|Weeks 0-36|||||||
1333892|NCT02032433|Secondary|Alcohol and Other Drug Use, Over Time|Self report of alcohol and other drug use by participants using TLFB. At each visit the TLFB was completed for dates going back to the last participant encounter. Confirmatory UDS was done at each in person visit.|Weeks 0-36|||||||
1333893|NCT02032433|Secondary|Opioid Abstinence Over Time While on Study Medication (Subjective)|Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.|Weeks 0-24|per protocol|||days||Inter-Quartile Range|Median
1333894|NCT02032433|Secondary|Adverse Events Related to Study Medications|Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.|Weeks 0-36|These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.|||events|||Number
1333895|NCT02032433|Secondary|Number Successfully Inducted Onto Assigned Study Medication|Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.|Weeks 0-24|Intent to treat|||participants|||Number
1333896|NCT02032433|Primary|Time to Relapse (Per Protocol Population)|Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.|Weeks 3-24|Per protocol population (those successfully inducted onto medication)|||weeks||95% Confidence Interval|Median
1333897|NCT02032433|Primary|Time to Relapse (Intent to Treat Population)|Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.|Weeks 3-24|Intention to treat.|||weeks||95% Confidence Interval|Median
1333898|NCT02032420|Post-Hoc|Inability to Complete Assigned Task at All in Three Attempts|Some participants found the task too difficult to complete.|Immediately after training||||participants|||Number
1333899|NCT02032420|Secondary|Performer Fatigue|Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue|During task||||units on a scale||Inter-Quartile Range|Median
1333900|NCT02032420|Secondary|Needle-not-seen Time|Median percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm|During attempt||||percentage of attempt time||Inter-Quartile Range|Median
1333901|NCT02032420|Primary|Task Completion Time|Median time taken to complete 3 iterations of the assigned task, across participants within a study arm|Immediately after training||||seconds||Inter-Quartile Range|Median
1333902|NCT02032407|Secondary|ASIS Impact Domain Score|The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
1333903|NCT02032407|Secondary|Acne Symptom and Impact Scale (ASIS) Sign Domain Score|The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data at the given time-point.|||score on a scale||Standard Deviation|Mean
1334053|NCT02029521|Secondary|Severity of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334054|NCT02029521|Secondary|Frequency of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1333904|NCT02032407|Secondary|Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.|Weeks 2, 6 and 12|Participants from the mITT, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percentage of participants|||Number
1333905|NCT02032407|Secondary|Percent Change From Baseline in Non-Inflammatory Lesion Counts|The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percent change||Standard Deviation|Mean
1333906|NCT02032407|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts|The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percent change||Standard Deviation|Mean
1333907|NCT02032407|Secondary|Percent Change From Baseline in Total Lesion Counts|The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percent change||Standard Deviation|Mean
1333908|NCT02032407|Secondary|Change From Baseline in the GAAS|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Weeks 2 and 6|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1333909|NCT02032407|Primary|Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician|The investigator evaluated the participant’s acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1333910|NCT02032238|Primary|Percentage of Eyes That Received Retreatment||12 months||||Percentage of eyes that received retreat|||Number
1333911|NCT02032212|Secondary|Nicotine Craving|Craving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as “I have a desire for a cigarette right now”, by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette.|30 minutes after the third product use||||score on a scale||Standard Deviation|Mean
1333912|NCT02032212|Secondary|Nicotine Withdrawal Symptoms|Withdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject’s part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60.|30 minutes after the third product use||||score on a scale||Standard Deviation|Mean
1333913|NCT02032212|Secondary|Exhaled Carbon Monoxide|Measured with a Smokerlyser device|25 minutes||||ppm||Standard Deviation|Mean
1333914|NCT02032212|Primary|Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)||1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours||||min*ng/ml||Geometric Coefficient of Variation|Geometric Mean
1333915|NCT02032212|Primary|Nicotine Plasma Concentration|Maximum plasma nicotine concentration (Cmax)|1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1333916|NCT02031679|Secondary|The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape|The measure of Eosinophil shape change was assessed by cell scatter characteristics using a flow cytometer. Cellular scatter was established with buffer and then several doses of PGD2 stimulation.|Baseline, End of treatment, end of washout|Insufficient samples were obtained for one active and 2 placebo patients.|||Mean fluorescence units area under curve||Standard Deviation|Mean
1333917|NCT02031679|Secondary|The Number of Participants With Adverse Events|The safety of AZD1981 will be assessed using the following outcome measures: incidence and severity of treatment-emergent adverse events and serious adverse events, clinical laboratory measures, and vital signs. In particular we will measure CBC’s with differential at baseline and week 4 and liver function tests every 2 weeks based on past trial experience of dose-related toxicity.|8 weeks||||participants with adverse events|||Number
1334055|NCT02029521|Secondary|Severity of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1333918|NCT02031679|Primary|The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)|The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. UAS is a validated measure of Chronic Spontaneous Urticaria (CSU) disease activity which scores the intensity of pruritus (0–3, with 0 = no itch and 3 is severe itch) and number of hives (0–3 0 means no hives and 3 means greater than 50 hives) with a maximum value of 6 for a given day. The UAS7 is the sum of the daily average UAS scores (average of a.m. and p.m.) for 7 days with a minimum score of 0 and a maximum value of 42. The UAS7 is a sum of the daily average (average of a.m. and p.m.) for 7 days. The baseline score was established during the second placebo therapy week and compared to the final week of the 4 week active treatment period.|7 Days|One placebo subject had diary data compromised by device malfunction so only full data for 11 subjects were analyzed|||UAS7 Scores||Standard Error|Mean
1333919|NCT02031640|Secondary|Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period|"A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient’s overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol."|Treatment period: Day 1 up to Week 12|Full analysis set|||Participants|||Count of Participants
1333920|NCT02031640|Secondary|Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma|"Time to withdrawal due to meeting stopping criteria is defined as number of days elapsed from the date of the first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Stopping criteria are:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at RV.~Based upon review of patient diary data, the patient has experienced any of the following during any 7-day period:~4+ days in which the highest (of 3 efforts) am PEF fall below the PEF stability limit calculated when randomized. The patient meets with the investigator who determines whether the FEV1 is consistent with worsening asthma;~3+ days in which 12+ inhalations/day of rescue medication were used~2+ days in which the patient experienced a nighttime asthma symptom score of more than 2~Clinical asthma exacerbation requiring (for example) the use of systemic corticosteroids, or the emergency room or hospitalization."|Day 1 - Week 12|Full analysis set; unable to calculate as few patients met stopping criteria|||days||95% Confidence Interval|Median
1333921|NCT02031640|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)|Asthma symptom scores are recorded in the patient’s diary each morning and each evening before determining PEF and before administration of study or rescue medications. The Daytime Symptom Score (determined in the evening) has a range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. The Nighttime Symptom Score (determined in the morning) has a range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score is the average of the daytime and the nighttime scores (full scale is 0 - 4.5). The total daily asthma symptom score is missing if either the daytime or nighttime score is missing. Baseline was the average of recorded daily asthma symptom scores over 7 days prior to the first dose of study treatment. The weekly average was the sum of total daily asthma symptom scores over the 7 days divided by the number of non-missing assessments.|Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12|Full analysis set. Analysis used a MMRM with effects due to baseline score, sex, age, time, treatment, and time-by-treatment interaction.|||units on a scale||Standard Error|Least Squares Mean
1333922|NCT02031640|Secondary|Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)|"Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including the morning usage at the randomization visit.~Weekly average rescue medication data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). Weekly average over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline value, sex, age, time, treatment, and time-by-treatment interaction."|Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12|Full analysis set|||number of inhalations||Standard Error|Least Squares Mean
1333923|NCT02031640|Secondary|Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)|"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.~Weekly average PEF data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening peak PEF, sex, age, treatment, time, and time by treatment interaction."|Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12|Full Analysis Set|||Liters/minute||Standard Error|Least Squares Mean
1333932|NCT02031471|Secondary|Change From Baseline in Arthritis Impact Measurement Scale-Short Form (AIMS-SF)|The AIMS-SF is a reduced version of the validated AIMS2 questionnaire. The Short Form has been developed using a comprehensive expert-based approach and supported by psychometric testing. The AIMS-SF is a self-administered questionnaire to measure changes in global health, pain, mobility and social function in adult patients with arthritis and reports scores for physical, symptoms, affect, social and work assessments. Scores range from 0 to 10, higher scores indicating higher impact of arthritis on the assessments. A negative change from baseline indicates an improvement.|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333924|NCT02031640|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)|"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. Daily trough morning PEF assessments were taken pre-dose and pre-rescue bronchodilator over the 12-week treatment period. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in trough morning PEF is defined as the average of recorded trough morning PEF assessments over the 7-day window before randomization, including the morning assessment on Day 1 before randomization.~Weekly average PEF data was generated using 7-day windows based on analysis days (before the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time by treatment interaction."|Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12|Full Analysis Set|||Liters/minute||Standard Error|Least Squares Mean
1333925|NCT02031640|Primary|Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )|"Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used.~Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule.~The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t <12 weeks (2, 4, or 8 weeks)."|Day 1 (baseline), Weeks 2, 4, 8, 12|Full analysis set- randomized patients with at least 1 dose of drug and 1 postbaseline trough am FEV1|||Liters||Standard Error|Least Squares Mean
1333926|NCT02031471|Secondary|Safety: Percentage of Participants With Anti-tocilizumab Antibodies||Baseline, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1333927|NCT02031471|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 52 weeks|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1333928|NCT02031471|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM ) Scores|The abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) derived from the TSQM Version 1.4 but without the five items of the side effects domain, is a reliable and valid measure to assess participants’ satisfaction with treatment. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Domains included are effectiveness, convenience and global satisfaction.|Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333929|NCT02031471|Secondary|Change From Baseline in Work Instability Scale for Rheumatoid Arthritis (RA-WIS)|The 23-item RA-WIS is a simple, validated screening tool for work instability, i.e., the consequences of a mismatch between an individual’s functional ability and their work tasks. This self-administered questionnaire covers a broad range of specific work-related issues and enables monitoring the risk of work disability in rheumatoid arthritis patients. The RA-WIS is scored by summing responses from all 23 scale items. The scale ranges from 0 to 23. Cut points have been established to differentiate levels of work instability: low < 10, moderate 10-17 and high > 17. A negative change from baseline indicates an improvement.|From Baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333930|NCT02031471|Secondary|Change From Baseline in Patient Satisfaction VAS|The Patient Satisfaction VAS assessment represents the participant’s assessment of his/her current satisfaction with treatment on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no satisfaction” and the extreme right end 100=“extremely satisfied”. A positive change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333931|NCT02031471|Secondary|Change From Baseline in Patient Fatigue VAS|The Patient Fatigue VAS assessment represents the participant’s assessment of his/her current level of fatigue on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no fatigue” and the extreme right end 100=“extreme fatigue”. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333933|NCT02031471|Secondary|Change From Baseline in Patient Quality of Sleep VAS|The Patient Quality of Sleep VAS assessment represents the participant’s assessment of his/her current quality of sleep on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no difficulty to sleep” and the extreme right end 100=“extreme sleeping difficulties”. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333934|NCT02031471|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over 1-month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The participant self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. Global scores range from 0 to 21 and a global sum of “5” or greater indicates a “poor” sleeper. Although there are several questions that request the evaluation of the participant’s bed mate or roommate, these are not scored. A negative change from baseline indicates an improvement.|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333935|NCT02031471|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The symptom-specific measure FACIT-F was developed to assess chronic illness therapy with special emphasis on fatigue in the past 7 days. In this study, only the FACIT-F short questionnaire, which is a shorter version of the initial FACIT-F questionnaire, was used. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. The 13 items included in the FACIT-F short can be used to calculate the brief score for FACIT-F scale (score range: 0-52). A positive change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333936|NCT02031471|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333937|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in ESR|A negative change from baseline in ESR indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||millimeters per hour (mm/hr)||Standard Deviation|Mean
1333938|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in CRP|A negative change from baseline in CRP level indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||milligrams per liter (mg/L)||Standard Deviation|Mean
1333939|NCT02031471|Secondary|Change From Baseline in Patient’s Assessment of Pain VAS|Patient’s Assessment of Pain VAS represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line represents 0=“no pain” and the extreme right end 100=“unbearable pain”. A negative change from baseline indicates an improvement.|From Baseline to Week 2 and Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333940|NCT02031471|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity VAS|PGA VAS represents the participant’s overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end 100=“maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333941|NCT02031471|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity VAS|Physician’s Global Assessment of disease activity VAS represents the physician’s assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end 100= “maximum disease activity”. This was completed by the Treating Physician (or designee). A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333942|NCT02031471|Secondary|Percentage of Participants Achieving a Clinically Significant Improvement in DAS28|The DAS28 score is a measure of the participant’s disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1333943|NCT02031471|Secondary|Percentage of Participants Achieving DAS28-ESR Remission, DAS28-ESR LDA, Moderate Disease Activity and High Disease Activity|The DAS28 score is a measure of the participant’s disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. Clinical remission = score <2.6; Low disease activity = score ≥2.6 and ≤3.2; Moderate disease activity = score > 3.2 and ≤5.1; High disease activity = score >5.1.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1333944|NCT02031471|Secondary|Percentage of Participants Achieving SDAI Remission, SDAI LDA, Moderate Disease Activity and High Disease Activity|SDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total SDAI score ranges from 0 to 86 with higher scores indicating increased disease activity. Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; high disease activity = score > 26.0.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1333945|NCT02031471|Secondary|Percentage of Participants Achieving CDAI Remission, CDAI Low Disease Activity, Moderate Disease Activity and High Disease Activity|CDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total CDAI score ranges from 0 to 76 with higher scores indicating increased disease activity. Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; High disease activity = score > 22.0.|Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1333946|NCT02031471|Secondary|Percentage of Participants With Corticosteroid Dose Reduction/Discontinuation||Up to Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1333947|NCT02031471|Secondary|Change in Total Tender/Swollen Joint Counts (TJC/SJC)|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure|||Joint Counts||Standard Deviation|Mean
1333948|NCT02031471|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI)|SDAI is a similar index to DAS28 but has the advantage of not needing a complicated mathematical formula for its determination, but a simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. CDAI does not incorporate an acute response, therefore it can be used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. SDAI scores ranged from 0 to 86, CDAI from 0 to 76 with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333949|NCT02031471|Secondary|Percentage of Participants With Responses According to European League Against Rheumatism (EULAR ) Criteria|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of <=3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to <=1.2 with a DAS28 score of <=5.1; non-responders = decrease from baseline <=0.6 or decrease from baseline >0.6 and <=1.2 with a DAS28 score of >5.1.|From Baseline to Week 2, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1333950|NCT02031471|Secondary|Percentage of Participants With Positive American College of Rheumatology (ACR) Response Scores|The ACR core set of outcome measures and their definition of improvement includes a >= 20% improvement (ACR20) compared to Baseline in both SJC and TJC as well as in three out of five additional parameters: Physician’s Global Assessment of disease activity VAS, PGA VAS, patient’s assessment of pain VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and acute phase reactant (CRP or ESR). VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Achievement of an ACR50 requires a >= 50% improvement in the same parameters and an ACR70 requires a >= 70% improvement.|From Baseline to Week 2, Week 24, and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1334056|NCT02029521|Secondary|Frequency of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334057|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|6 Months||||participants|||Number
1333951|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Per Protocol Set (PPS)|The DAS28 score is a measure of the participant’s disease activity calculated using the TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS and acute phase reactant (ESR or CRP) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The PPS consisted of all participants of the FAS having a value at baseline and at Week 24 for the endpoint DAS28-ESR, excluding sponsor defined deviation(s) which could have affected the evaluation of the primary endpoint (DAS28-ESR). Here, n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333952|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Full Analysis Set (FAS)|The DAS28 score is a measure of the participant’s disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient’s global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1333953|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1|PD was defined as at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5 mm).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.|||percentage of participants|||Number
1333954|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1|PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.|||percentage of participants|||Number
1333955|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1|PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.|||percentage of participants|||Number
1333956|NCT02031458|Secondary|Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status|Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.|Baseline, post-baseline (up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point. Number of participants analyzed = number participants who were evaluable for this outcome.|||percentage of participants|||Number
1333957|NCT02031458|Secondary|Atezolizumab Serum Concentrations|Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.|Pre-dose (hour 0) and 0.5 hours post dose on Cycle 1 Day 1 (Cycle length = 21days), Cycle 1 Days 2, 4, 8, 15, and 21, Cycle 2 Day 21, Cycle 3 Day 21, Cycle 7 Day 21|Pharmacokinetic evaluable population; n = number of participants analyzed for the specified time point.|||micrograms per milliliter (μg/mL)||Standard Deviation|Mean
1333958|NCT02031458|Secondary|TIR as Assessed by IRF Per RECIST v1.1|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population|||months||95% Confidence Interval|Median
1333959|NCT02031458|Secondary|TIR as Assessed by INV Per Modified RECIST|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by modified RECIST. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population|||months||95% Confidence Interval|Median
1333992|NCT02030535|Secondary|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333960|NCT02031458|Secondary|Time in Response (TIR) as Assessed by INV Per RECIST v1.1|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population|||months||95% Confidence Interval|Median
1333961|NCT02031458|Secondary|PFS: Percentage of Participants Alive and Progression Free at 12 Months|PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Month 12|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
1333962|NCT02031458|Secondary|PFS: Percentage of Participants Alive and Progression Free at 6 Months|PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Month 6|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
1333963|NCT02031458|Secondary|Percentage of Participants Without an Event (Death) at 12 Months||Month 12|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
1333964|NCT02031458|Secondary|Percentage of Participants Without an Event (Death) at 6 Months||Month 6|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
1333965|NCT02031458|Secondary|Overall Survival : Median Time to Event (Death)|Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
1333966|NCT02031458|Secondary|Overall Survival : Percentage of Participants Without Event (Death)||Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants|||Number
1333967|NCT02031458|Secondary|PFS as Assessed by INV Per Modified RECIST|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by modified RECIST. PD: at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5mm). PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
1333968|NCT02031458|Secondary|PFS as Assessed by INV Per RECIST v1.1|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
1333969|NCT02031458|Secondary|Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
1333970|NCT02031458|Secondary|DOR as Assessed by INV Per Modified RECIST|DOR is the interval between the date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: at least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR; PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of existing and/or new target lesions (with an absolute increase of at least 5mm). DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome|||months||95% Confidence Interval|Median
1334058|NCT02029521|Secondary|Alanine Aminotransferase (ALT)|ALT was measured to determine if liver function was affected by treatment over the course of the study.|6 Months|All participants.|||units per liter||Standard Deviation|Mean
1333971|NCT02031458|Secondary|DOR as Assessed by INV Per RECIST v1.1|DOR is interval between date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.|||months||95% Confidence Interval|Median
1333972|NCT02031458|Secondary|Duration of Response (DOR) Assessed by IRF Per RECIST v1.1|DOR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.|||months||95% Confidence Interval|Median
1333973|NCT02031458|Secondary|Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV|ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n= number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
1333974|NCT02031458|Secondary|Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)|ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
1333975|NCT02031458|Primary|Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF)|ORR was the percentage of participants whose confirmed best overall response was either a Partial Response (PR) or a Complete Response (CR) based upon the IRF assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm); PR:greater than (>) or equal to (=) 30 percent (%) decrease from baseline in sum of diameters of target lesions, non-progressive disease (PD) non-target lesions and no new lesions. Results were reported by line of therapy and programmed death-ligand 1 (PD-L1) Expression Subgroup (tumor cell [TC]3 [TC3] or tumor-infiltrating immune cell [IC] 3 [IC3], TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; Number (n) equals (=) number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
1333976|NCT02030600|Secondary|FPG (Fasting Plasma Glucose)|Fasting plasma glucose values at week 32 and week 64.|week 32, week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.|||mg/dL||Standard Deviation|Mean
1333977|NCT02030600|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64.|Week 32, Week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1333978|NCT02030600|Secondary|Incidence of Treatment Emergent Adverse Events|Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|During 32 weeks of treatment for each treatment period|Safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator (Total number of subjects analysed for this endpoint: 713).|||events|||Number
1333979|NCT02030600|Secondary|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period|Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set. Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on subjects in full analysis set with exposure in both maintenance periods.|||percentage of subjects|||Number
1333980|NCT02030600|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period|Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set|||events|||Number
1333981|NCT02030600|Primary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set|||events|||Number
1333982|NCT02030574|Secondary|Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer|Toxicities assessed while patients are on treatments|Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)||||participants|||Number
1333983|NCT02030574|Primary|Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.|Response will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 [Eur J Cancer. 2009;45:228-247.].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficie|at approximately 6 months||||participants|||Number
1333984|NCT02030535|Secondary|QRS Change From Patient Baseline at Individual Post-dose Time Points|QRS change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333985|NCT02030535|Secondary|Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333986|NCT02030535|Secondary|Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333987|NCT02030535|Secondary|PR Change From Patient Baseline at Individual Post-dose Time Points|PR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333988|NCT02030535|Secondary|Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333989|NCT02030535|Secondary|Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333990|NCT02030535|Secondary|QTcB Change From Patient Baseline at Individual Post-dose Time Points|QTcB change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1333991|NCT02030535|Secondary|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1334000|NCT02030535|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration|"The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).~For patients who did not complete all periods, patient baseline was the average of the available period baselines.~The means presented are the adjusted means."|1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose|Full Analysis Set (FAS): This patient set included all patients in the TS who had at least 1 visit (Visit 2(Day1), Visit 3(Day22), or Visit 4(Day43)) with both the period baseline value plus any evaluable post-dose spirometry measurement from the same visit.|||Litres||Standard Error|Mean
1334001|NCT02030535|Secondary|Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||bpm||Standard Deviation|Mean
1334002|NCT02030535|Secondary|Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||bpm||Standard Deviation|Mean
1334003|NCT02030535|Secondary|Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1334004|NCT02030535|Secondary|Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
1334005|NCT02030405|Secondary|Overall Survival (OS)|Overall survival (OS) from time of study entry to the earlier of death from any cause or end of follow up at 1 year|1 year||||Participants|||Count of Participants
1334006|NCT02030405|Primary|Overall Response Rate|"Overall response rate after 3 cycles of treatment (9 weeks) was assessed as complete remission (CR); CR with incomplete recovery (CRi); and partial remission (PR) with MLN9708, in patients with NPM1-mutated AML by LeukemiaNet1 guidelines:~CR is defined as either a full CR, or a CR with incomplete recovery. Although achievement of CR has unique clinical significance for improved overall survival and relapsed free survival compared to achievement of CR with incomplete platelet recovery, the latter is still a clinically meaningful response, as it is independently superior to resistant disease. Partial remission (PR) is defined as meeting all hematologic criteria for CR with an allowance for 5% to 25% bone marrow blasts or decrease of pretreatment bone marrow blast percentage by at least 50%. Stable disease is defined as a change in bone marrow aspirate blast count within 10% of baseline. Relapsed disease is defined as reappearance of blasts in the blood or bone marrow blasts"|9 weeks||||Participants|||Count of Participants
1334007|NCT02030119|Secondary|Average Number of Steps Per Day|Secondary outcomes include average number of steps each individual takes per day throughout the 13-week intervention and additional 13-week follow-up periods.|Throughout the 6 month study||||Steps per day||95% Confidence Interval|Mean
1334008|NCT02030119|Primary|Proportion of Days Each Individual Walks 7000 Steps Per Day or More|The primary outcome measure is the mean proportion of participant-days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives.|Throughout the 6 month study||||Proportion of participant-days||95% Confidence Interval|Mean
1334009|NCT02030080|Secondary|Average Number of Steps Per Day|Secondary outcomes include average number of steps per day during the incentive period (first 3 months) and follow-up period (second 3 months).|Throughout the 6-month study||||Mean daily step counts||95% Confidence Interval|Mean
1334010|NCT02030080|Primary|Proportion of Days a Participant Walks 7000 Steps or More|The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Below we report the highest mean proportions found.|Throughout 6-month study||||Mean proportion||95% Confidence Interval|Mean
1334011|NCT02030041|Primary|Skeletal Muscle Mitochondrial Content|Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer’s instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.|Twelve weeks||||change in mOD/min at 412nm||Standard Deviation|Mean
1334012|NCT02030041|Primary|Peak Oxygen Consumption|Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%).|Twelve weeks||||percentage of predicted value||Standard Deviation|Mean
1334013|NCT02029989|Primary|Metabolic Syndrome (MetS)|compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline|Baseline||||percentage of participants|||Number
1334014|NCT02029911|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat|||participants|||Number
1334015|NCT02029911|Secondary|Procedure Time|Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal.|< 1 hour|Subjects completing treatment|||Minutes||Standard Deviation|Mean
1334017|NCT02029872|Primary|Number of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization|Participants were decolonized with a standard Methicillin-resistant Staphylococcus aureus (MRSA) decolonization protocol and monitored for 6 months. This is the number of participants who screened positive for Methicillin-resistant Staphylococcus aureus (MRSA) 6 months after being decolonized (i.e., recurrent infection)|6 months|"Only participants who received the decolonization protocol and completed the 6 month follow-up visit (7 for individual alone' and 6 for 'Individual plus household') were included in the analysis. The rest were lost to follow up"|||Participants|||Count of Participants
1334018|NCT02029846|Other Pre-specified|Diabetes Quality of Life|Data not analyzed due to n=1 each arm|6 months|Data not analyzed due to n=1 each arm||||||
1334019|NCT02029846|Secondary|Overall Hypoglycemia Measured by Glucose Meter|Data not analyzed due to n=1 each arm.|6 months|Data not analyzed due to n=1 each arm.||||||
1334020|NCT02029846|Primary|Time to Achieve Glycemic Target (HbA1c <7.5%).|Data not analyzed due to n=1 each arm.|6 months|Data not analyzed due to n=1 each arm.||||||
1334021|NCT02029755|Secondary|Number of Participants With Intervention-related Complication|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
1334022|NCT02029755|Secondary|Length of Hospital Stay|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
1334023|NCT02029755|Secondary|Time to Flatus|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
1334024|NCT02029755|Secondary|Heart Rate Variability||preoperative, postoperative 1 hour and 1 day|||||||
1334025|NCT02029755|Secondary|Quality of Recovery 40||postoperative 48 hour|||||||
1334026|NCT02029755|Secondary|Pruritus||postoperative 1, 6, 24, 48 hour|||||||
1334027|NCT02029755|Secondary|Time to the First Request of Analgesics|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
1334028|NCT02029755|Secondary|Rescue Antiemetics Use||postoperative 1, 6, 12, 24, 36, 48 hour|||||||
1334029|NCT02029755|Secondary|Rescue Analgesic Use||postoperative 1, 6, 12, 24, 36, 48 hour|||||||
1334030|NCT02029755|Secondary|Nausea and Vomiting Categorical Score||postoperative 1, 6, 24, 48 hour|||||||
1334031|NCT02029755|Secondary|Sedation Scale||postoperative 1, 6, 24, 48 hour|||||||
1334032|NCT02029755|Primary|Opioid Consumption|opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).|postoperative 48 hour||||mg||Standard Deviation|Mean
1334033|NCT02029755|Primary|Pain Score (NRS: Numerical Rating Scale)|"pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours).~(NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome."|postoperative 24 hour dynamic||||units on a scale||Standard Error|Mean
1334034|NCT02029703|Primary|Difference in Pain Score Between Groups|"The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection.~The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score."|12 and 24 weeks||||units on a scale||Standard Deviation|Mean
1334035|NCT02029521|Secondary|Severity of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334036|NCT02029521|Secondary|Frequency of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334037|NCT02029521|Secondary|Severity of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334038|NCT02029521|Secondary|Frequency of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334039|NCT02029521|Secondary|Severity of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334040|NCT02029521|Secondary|Frequency of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334041|NCT02029521|Secondary|Severity of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334042|NCT02029521|Secondary|Frequency of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334043|NCT02029521|Secondary|Severity of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334044|NCT02029521|Secondary|Frequency of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334045|NCT02029521|Secondary|Severity of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334046|NCT02029521|Secondary|Frequency of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334047|NCT02029521|Secondary|Severity of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334048|NCT02029521|Secondary|Frequency of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334049|NCT02029521|Secondary|Severity of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334050|NCT02029521|Secondary|Frequency of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
1334051|NCT02029521|Secondary|Severity of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
1334074|NCT02029495|Secondary|Psoriasis Area and Severity Index (PASI)75|PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.|16 Weeks||||percentage of participants||95% Confidence Interval|Number
1334075|NCT02029495|Primary|American College of Rheumatology (ACR) 20 Response|An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient’s assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).|16 weeks||||percentage of participants||95% Confidence Interval|Number
1334076|NCT02029417|Primary|Frequency of Adverse Events, Graded According to NCI CTCAE v4.0|Maximum grade per participant of any AE.|Up to 30 days after last dose of study drugs|All treated and eligible patients.|||participants|||Number
1334077|NCT02029417|Primary|Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups|Defined as recovery of morphologically normal bone marrow (< 5% blasts) and blood counts (absolute neutrophil count >= 1x10^9/L, platelet counts >= 100x10^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated.|Up to 4 years|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1334078|NCT02029196|Secondary|Exhaled Carbon Monoxide|Level of exhaled carbon monoxide at Week 12|12 weeks|Measure performed on subjects who completed the 12-week study (286 in the e-vapour product arm and 100 in the conventional cigarette arm).|||parts per million (ppm)||Standard Deviation|Mean
1334079|NCT02029196|Primary|Adverse Events|Frequency of adverse events|12 weeks|All subjects who used the study product at least once.|||percentage of adverse events||95% Confidence Interval|Least Squares Mean
1334080|NCT02028780|Secondary|AUEC2-12|"Area under the effect curve over the time interval from 2 to 12h, AUEC2-12 on Days 4 and 11 for diluted thrombin time (dTT).~For dose groups 5 to 7(day4-Part-II): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h on day 4. For dose groups 5 to 7(day11-Part-II): 242h, 242.083h, 242.167h, 242.5h, 243h, 244h, 246h, 248h, 250h, 252h. For dose groups 8(day4-Part-II): 74.5 h, 78 h, 84 h on day 4. For dose groups 8(day11-Part-II): 242h, 242.083h,242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h on day 11.~AUEC is calculated by multiplying the ratio (Value at each time point/Ebase, unit of Vaue is [s] and Ebase is value [s] at baseline) by time. Therefore, Unit for AUEC2-12 is [h]."|Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section|Pharmacodynamic set (PDS): The PDS comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment pharmacodynamic observation.|||h||Standard Deviation|Mean
1334081|NCT02028780|Secondary|Ae0-73 for the Dose Group 4 in the Part I|Amount of the analyte excreted in urine over the time interval 0-73|For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h|PKS set. The results from dose group 4 has been disclosed, because only dose group 4 had 1hr infusion, Ae 0-73 was reported, instead of Ae0-72.|||μmol||Geometric Coefficient of Variation|Geometric Mean
1334082|NCT02028780|Secondary|Ae0-72 for Idarucizumab in the Part I & Part II.|Amount of idarucizumab eliminated in urine over the time interval 0-72. Time frame: For dose groups 1 to 3 (day1 to day4-Part-1):0–4 h, 4–8 h, 8–12 h, 12–24 h, 24–48 h, 48–72 h. For dose groups 5 to 7 (day 11 to day14-Part-II): 0-4 h, 4–8 h, 8–10 h, 10–12 h,12–24 h, 24–48 h, and 48–72 h. For dose groups 8 (day11 to day14-Part-II): 0-4h, 4–8 h, 8–10 h, 10–24 h, 24–48 h, 48–72 h.|Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section|PKS set. Ae 0-72 data is not available for BI8000mg_1h (Dose group 4 - Part I) due to longer infusion time resulting different urine collection interval. Instead, Ae 0-73 is presented for BI8000mg_1h as separate endpoint.|||μmol||Geometric Coefficient of Variation|Geometric Mean
1334083|NCT02028780|Secondary|AUC0-inf for Idarucizumab in the Part I & Part II.|"Area under the concentration-time curve of the analyte in plasma for idarucizumab over the time interval from 0 extrapolated to infinity.~Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h."|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1334084|NCT02028780|Secondary|Cmax for Idarucizumab in the Part I & Part II.|Maximum measured concentration of the analyte in plasma for idarucizumab Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h.|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1334085|NCT02028780|Secondary|AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).|"Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours.~Time Frame: For dose group 5 to 7 (Day 1 to 3-Part-I):74hours (h), 74.5h, 75h, 76h, 78h, 80h, 82h, 84h, For dose group 8 (Day 1 to 3-Part-I): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h and For dose group 5-7 (Day11 to Day13-Part II):242h, 242.167h, 242.5h, 243h, 244h,246h, 248h, 250h, 252h. For dose group 8 (Day11 to Day13-Part II):242h, 242.083h, 242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h."|Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section|PKS set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334086|NCT02028780|Secondary|Ae0−74,ss on Days 4 and 11 for Sum Dabigatran (Part II)|Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours.|0–2 h, 2–6 h, 6–10 h, 10–12 h,12–14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.|PKS set: This subject set included all subjects who received the idarucizumab and who had at least one pharmacokinetic parameter. For the Part 2, subjects who had the emesis with onset at or before twice the median tmax of dabigatran were not included in this set.|||μg||Geometric Coefficient of Variation|Geometric Mean
1334087|NCT02028780|Primary|Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2|Percentage of subjects with drug-related adverse events in Part 1 and Part 2.|From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)|Treated set (TS)|||Percentage of participants|||Number
1334088|NCT02028767|Secondary|AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-infinity) (Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334089|NCT02028767|Primary|Cmax (Maximum Measured Concentration of Metformin in Plasma)|Cmax (maximum measured concentration of metformin in plasma)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334090|NCT02028767|Primary|AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)|AUC (0-tz) (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334091|NCT02028754|Secondary|Subjective Symptom Total Score in the Study Eye|The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst).|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1334092|NCT02028754|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1334093|NCT02028754|Secondary|Results of Schirmer I Test With Anesthetics in the Study Eye|The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms.|Day 7, Day 30|All patients with data at this time point|||Millimeters||Standard Deviation|Mean
1334094|NCT02028754|Secondary|Lissamine Green Staining Score in the Study Eye|Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1334095|NCT02028754|Secondary|Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1334096|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 30|All patients with data at this time point|||Seconds||Standard Deviation|Mean
1334097|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 7|All patients with data at this time point|||Seconds||Standard Deviation|Mean
1334224|NCT02025647|Secondary|Subject Survey (Question 1)|I am satisfied with how I was able to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334098|NCT02028676|Secondary|Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||% of visits reporting missed pills||Standard Deviation|Mean
1334099|NCT02028676|Secondary|Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334100|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants aged >5 years at randomization to stop versus continue alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
1334101|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%|||percentage of total lymphocytes||Standard Deviation|Mean
1334102|NCT02028676|Secondary|Cotrimoxazole: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||age-adjusted z-score||Standard Deviation|Mean
1334103|NCT02028676|Secondary|Cotrimoxazole: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||age-adjusted z-score||Standard Deviation|Mean
1334104|NCT02028676|Secondary|Cotrimoxazole: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||age-adjusted z-score||Standard Deviation|Mean
1334105|NCT02028676|Secondary|Cotrimoxazole: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334106|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334107|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea|Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334108|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334109|NCT02028676|Secondary|Cotrimoxazole: New Severe Pneumonia|Number of participants with a new severe pneumonia, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334110|NCT02028676|Secondary|Cotrimoxazole: New Clinical and Diagnostic Positive Malaria|Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT)|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334111|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||% of visits reporting missed pills||Standard Deviation|Mean
1334112|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks.|96 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire|||participants|||Number
1334113|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks.|48 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire|||participants|||Number
1334240|NCT02025621|Other Pre-specified|Occurrence of All-cause Mortality From Randomization Through Day 90||90 days|all patients receiving study drug, according to the drug actually received|||Participants|||Count of Participants
1334114|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
1334115|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
1334116|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||age-adjusted z-score||Standard Deviation|Mean
1334117|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||age-adjusted z-score||Standard Deviation|Mean
1334118|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||age-adjusted z-score||Standard Deviation|Mean
1334119|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
1334120|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
1334121|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
1334122|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Randomisation to once vs twice daily, week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
1334123|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Baseline, week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
1334124|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Randomisation to once vs twice daily, week 48|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
1334125|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96||Randomisation to once vs twice daily, week 96|All participants alive in follow-up with CD4%|||percentage of lymphocytes||Standard Deviation|Mean
1334126|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%|||percentage of total lymphocytes||Standard Deviation|Mean
1334127|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48||Randomisation to once vs twice daily, week 48|All participants alive in follow-up with CD4%|||percentage of total lymphocytes||Standard Deviation|Mean
1334128|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|96 weeks|All participants with viral load assayed in stored specimens (98% of those randomized)|||participants|||Number
1334129|NCT02028676|Secondary|LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||% of visits reporting missed pills||Standard Deviation|Mean
1334130|NCT02028676|Secondary|LCM vs CDM, Induction ART: New ART-modifying Adverse Event|Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334131|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse events not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334132|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART|Number of participants with a new grade 3 or 4 adverse event definitely/probably or uncertainly related to ART, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334133|NCT02028676|Secondary|LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure|Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334134|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|144 weeks|Viral load was assayed retrospectively at week 144 on a random subset of participants, plus all those aged <5 years at enrolment|||participants|||Number
1334135|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|72 weeks|Viral loads were assayed retrospectively in a random subset of children|||participants|||Number
1334136|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 144|All participants alive in follow-up with CD4|||absolute cells per mm3||Standard Error|Mean
1334137|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants alive in follow-up with CD4|||absolute cells per mm3||Standard Error|Mean
1334138|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 144||Baseline, week 144|All participants alive in follow-up with CD4% (95% completeness)|||percentage of total lymphocytes||Standard Error|Mean
1334139|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4% (97% completeness)|||percentage of total lymphocytes||Standard Error|Mean
1334140|NCT02028676|Secondary|LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)||||age-adjusted z-score||Standard Deviation|Mean
1334141|NCT02028676|Secondary|LCM vs CDM, Induction ART: Height-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)||||age-adjusted z-score||Standard Deviation|Mean
1334142|NCT02028676|Secondary|LCM vs CDM, Induction ART: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)||||age-adjusted z-score||Standard Deviation|Mean
1334143|NCT02028676|Secondary|LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death|Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334144|NCT02028676|Secondary|LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334145|NCT02028676|Secondary|Induction ART: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334146|NCT02028676|Secondary|LCM vs CDM, Induction ART: All-cause Mortality|Number of participants who died from any cause, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334147|NCT02028676|Primary|Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334148|NCT02028676|Primary|Cotrimoxazole: New Hospitalisation or Death|Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
1334241|NCT02025621|Secondary|Postoperative Use of Secondary Inotrope|Use of (dobutamine, milrinone, epinephrine, dopamine) associated with index surgical procedure at 24 hours after initiation of surgery|24 hours||||Participants|||Count of Participants
1334149|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
1334150|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression.|48 weeks|All randomized participants with VL result from stored plasma specimen (available for 661/669, 99%, randomized participants)|||participants|||Number
1334151|NCT02028676|Primary|Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334152|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation||Baseline, 144 weeks|All participants alive in follow-up with CD4% (95% completeness)|||percentage of total lymphocytes||Standard Error|Mean
1334153|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation||Baseline, 72 weeks|All participants alive at 72 weeks with CD4 measured (completeness in those in follow-up was 96.6%).|||percentage of total lymphocytes||Standard Error|Mean
1334154|NCT02028676|Primary|LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
1334155|NCT02028676|Primary|LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death|Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|All randomized participants (time-to-event)|||participants|||Number
1334156|NCT02028325|Primary|Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging|We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.|up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation.||||participants|||Number
1334157|NCT02028169|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9|Number of participants with any serious adverse event (SAE) occurring during treatment with anti-TNF agents and/or participants who discontinued treatment due to SAEs or AEs which were caused by the treatment with anti-TNF agents during the course of treatment. An SAE is defined as an event that: results in the death; is life-threatening; results in an admission to the hospital or prolongation of hospitalization; is a congenital anomaly; results in a condition that substantially interferes with the activities of daily living of a study subject; is an important medical event according to the Investigator.|Up to Month 9|All participants|||Participants|||Count of Participants
1334158|NCT02028169|Secondary|Participant’s Assessment of Pain and Fatigue VAS Up to Month 9|A VAS was used to measure the participant's assessment of pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334159|NCT02028169|Secondary|Participant’s Assessment of Total Back Pain VAS Up to Month 9|A VAS was used to measure the participant's assessment of back pain. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334160|NCT02028169|Secondary|Participant’s Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9|A VAS was used to measure the participant's assessment of nocturnal back pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334161|NCT02028169|Secondary|Physician’s Global Assessment of Disease Activity VAS Up to Month 9|A VAS was used to measure the physician's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334162|NCT02028169|Secondary|Participant’s Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9|A VAS was used to measure the participant's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334163|NCT02028169|Secondary|C-reactive Protein (CRP) Up to Month 9|CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||mg/dL||Standard Deviation|Mean
1334164|NCT02028169|Secondary|Erythrocyte Sedimentation Rate (ESR) Up to Month 9|ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation.|Up to Month 9|Participants with an assessment at given time point.|||mm/h||Standard Deviation|Mean
1334165|NCT02028169|Secondary|Levels of Rheumatoid Factor||Up to Month 9|Since sufficient data could not be collected, this analysis was not performed.||||||
1334345|NCT02023801|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal|< 1 hour|Subjects completing treatment|||Minutes||Standard Deviation|Mean
1334166|NCT02028169|Secondary|Number of Tender Joints Up to Month 9|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||tender joints||Standard Deviation|Mean
1334167|NCT02028169|Secondary|Number of Swollen Joints Up to Month 9|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||swollen joints||Standard Deviation|Mean
1334168|NCT02028169|Secondary|Dactylitis Score Up to Month 9|A total of 20 digits were assessed as entire digits, looking for signs of tender dactylitis. Dactylitis is defined as a uniform swelling of the digits where the joints cannot be defined. Investigators entered scores between 0 (no swelling or pain) and 6 (most severe swelling and pain).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334169|NCT02028169|Secondary|Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9|For calculation of the enthesitis (tenderness) score, MASES was used in practice by the physicians. This scale takes into account the sites (first costochondral joint, seventh costochondral joint, posterior superior iliac spine, anterior superior iliac spine, iliac crest, fifth lumbar spinous process and proximal insertion of the Achilles tendon) and they scored from 0 to 13. Minimum tenderness score was 0; maximum tenderness score was 13.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334170|NCT02028169|Secondary|Disease Activity Score (DAS 28) Up to Month 9|"The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Participants were classified according to their scores as below:~DAS28 > 5.1 = High disease activity~DAS28 < 3.2 = Low disease activity~DAS28 < 2.6 = Remission"|Baseline, Month 3, Month 6, Month 9|All participants|||Participants|||Count of Participants
1334171|NCT02028169|Secondary|Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9|"A participant is an ACR20, ACR50, or ACR70 responder if the following 3 criteria for improvement from Baseline are met:~≥ 20%, ≥ 50%, or ≥ 70% improvement in tender joint count;~≥ 20%, ≥ 50%, or ≥ 70% improvement in swollen joint count; and~≥ 20%, ≥ 50%, or ≥ 70% improvement in at least 3 of the 5 following parameters:~Physician's global assessment of disease activity~Participant's global assessment of disease activity~Participant's assessment of pain~HAQ-DI~Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein)."|Month 9|Participants with an assessment.|||percentage of participants|||Number
1334172|NCT02028169|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9|The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide a total score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1334173|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9|Activity impairment due to PsA (the extent to which PsA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of activity impairment||Standard Deviation|Mean
1334174|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9|The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +[1- Absenteeism(%)*Presenteeism(%)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of OWPI||Standard Deviation|Mean
1334175|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9|Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of impairment while working||Standard Deviation|Mean
1334176|NCT02028169|Primary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9|Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of work time missed||Standard Deviation|Mean
1334191|NCT02027311|Primary|Number of Intervention|The frequency of intervention which was defined as any restraint of the patient’s head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.|Throughout the whole ERCP procedure||||Number of intervention||Standard Deviation|Mean
1334177|NCT02028065|Secondary|Percentage of Participants With Adjudicated Anaphylaxis|The investigator or designated clinician performed a THA in each participant at 0.5, 4 and 24 hours after each dose. The THA could also be performed at other times if possible hypersensitivity signs were observed. Each potential hypersensitivity case identified by presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of anaphylaxis (yes/no) using Sampson Criterion 1 - Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure or associated symptoms of end-organ dysfunction (J Allergy Clin Immunol 2006;117:391-397). All AEs occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.|||percentage of participants||95% Confidence Interval|Number
1334178|NCT02028065|Primary|Percentage of Participants With Adjudicated Symptoms of Hypersensitivity|The investigator or designated clinician performed a targeted hypersensitivity assessment (THA) in each participant at 0.5, 4 and 24 hours after each dose for each dosing period. The THA could also be performed at other times if possible hypersensitivity signs were observed. The THA included elicitation of symptoms as well as examination of the participant, covering neurologic, pulmonary, cardiovascular, gastrointestinal and dermatologic domains. Each potential hypersensitivity case identified by the presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of hypersensitivity (yes/no). In addition, all adverse events (AEs) occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.|||percentage of participants||95% Confidence Interval|Number
1334179|NCT02027883|Other Pre-specified|Safety Monitoring|Number of participants that were monitored for safety issues, including increased heart rate, blood pressure, decreased oximetry levels, and stable rhythm during the entire procedure.|2 hours||||participants|||Number
1334180|NCT02027883|Secondary|Factors|Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.|2 hours||||participants|||Number
1334181|NCT02027883|Primary|Sustained Ventricular Fibrillation|The primary endpoint is the successful induction of sustained ventricular fibrillation.|2 hours||||participants|||Number
1334182|NCT02027844|Other Pre-specified|Postoperative Behavioral Changes|"The investigators measure negative postoperative behavioral change of children after discharge of postanesthetic care unit using posthospital behavioral questionnaires( PHBQ ) at postoperative day (POD) 1 by visiting and followed at POD 14 by phone interview.~The PHBQ consists of 27 items concerning sleep, eating, anxiety, aggressive behaviour, etc.~The subscales were: general anxiety and regression, separation anxiety, anxiety about sleep, eating disturbance, aggression towards authority, and withdrawal.~Negative behavior change was evaluated in 6 subscales categories. If more than one negative behavior change developed, the investigators calculated number of children who developed new-onset negative behavior change."|1. postoperative 2 days, 2 postoperative 14 days|If more than one negative behavior change in children developed, the investigators calculated number of the children who developed new-onset negative behavior change.|||participants|||Number
1334183|NCT02027844|Other Pre-specified|Postoperative Emergence Delirium|"The investigators measure postoperative emergence delirium of children after recovery of anesthesia using Children's Hospital of Eastern Ontario Pain(CHEOP) Scale at 20 minute in postanesthetic care unit~The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort.~CHEOPS pain score = SUM(points for all 6 parameters) : Cry, facila, Child verbal, Torso, Touch, legs~Interpretation:~minimum score: 4 = no pain~maximum score: 13 = the worst pain~When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present."|at 20 minute in postanesthetic care unit|When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.|||participants|||Number
1334184|NCT02027844|Secondary|Change From Baseline Parental Anxiety at Postinduction of Anesthesia|"The investigators measure change of parental anxiety using State-Trait Anxiety Inventory (STAI)~The State-Trait Anxiety Inventory (STAI) is a psychological inventory and consists of 40 questions on a self-report basis.~The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.~Higher scores are positively correlated with higher levels of anxiety.~Each type of anxiety has its own scale of 20 different questions that are scored.~Scores range from 20 to 80, with higher scores correlating with greater anxiety."|1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia||||units on a scale||Inter-Quartile Range|Median
1334185|NCT02027844|Primary|Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction|"The investigators measure change in anxiety of children using Modified Yale Preoperative Anxiety scale (m-YPAS): Scale changes from Activities, Vocalization, Expressing emotions, State of arousal, Interaction with family members.~Each domain received a partial score based on the punctuation observed divided by the number of categories of that domain. The score of each domain is added to the others~Total scores ranged from 23.4 to 100 The scores considered “cut points” to determine whether a patient had/had not anxiety were 23~Without anxiety: 23.4 e 30~With anxiety: greater than 30."|1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane||||units on a scale||Inter-Quartile Range|Median
1334186|NCT02027402|Secondary|Postoperative Pain Score|Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.|6hr after operation - 24hr after operation - 48hr after operation||||units on a scale||Standard Deviation|Mean
1334187|NCT02027402|Secondary|Postoperative Hospital Stay||2weeks||||day||Standard Deviation|Mean
1334192|NCT02027272|Primary|Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery|To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.|36 months|Logistic hurdles caused to stop the study after the first participant and not proceed further. No analysis was undertaken.||||||
1334193|NCT02026453|Secondary|Mean Severity-Weighted Admission Medication Order (AMO) Error Score|The severity-weighted admission medication order (AMO) error score are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. Higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. For each AMH error identified, two physicians independently reviewed the relevant medications ordered at hospital admission in the context of the clinical chart. They classified each AMH error as either resulting in no AMO error, or an AMO error of significant, serious, or life-threatening severity. A third physician adjudicated disagreements. In cases where the admitting physician's knowledge of an AMH error was unclear and the orders clinically reasonable, we determined the AMH error did not lead to any AMO error. Because reviewers needed chart access to determine error severity, there was no practicable way to mask study arm.|Attempted to obtain the day after admission||||Mean Severity-Weighted AMO Error Score||95% Confidence Interval|Mean
1334194|NCT02026453|Primary|Mean Severity-weighted Admission Medication History (AMH) Error Score|The primary outcome was severity-weighted mean admission medication history (AMH) error score which are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. As such, higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening.|Attempted to obtain the day after admission||||Mean Severity-weighted AMH Error Score||95% Confidence Interval|Mean
1334195|NCT02026258|Secondary|Questionnaire Involving Pain Management and Satisfaction With the Procedure|"Binomial measurement in questionnaire on medications taken and satisfaction with the procedure~Did you take any pain medication after the procedure? Y/N (Count Yes)~Would you undergo this procedure again? Y/N (Count Yes)~Would you recommend this procedure to a friend? Y/N (Count Yes)"|4-5 weeks after first wire placement||||Participants|||Count of Participants
1334196|NCT02026258|Secondary|Questionnaire on Easiness and Satisfaction With the Procedure|"Visual analogue Scale from 0-100~Are you satisfied with your treatment? Very- Not Satisfied (0-100)~How easy was the procedure to you? Easy-Complicated (0-100)"|4-5 weeks after first wire placement||||units on a scale||Standard Deviation|Mean
1334197|NCT02026258|Secondary|Questionnaires Involving Pain Level|"Specific questions questionnaire included:~1) How much pain/discomfort at the following time points? 1) Immediately after first wire placement (T0), 2) 1 hour, (T1) 3) 12 hrs (T2) and 4) Seven days after (T3). Rated on a scale from 0-100 (No pain-Unbearable pain)"|Immediate to 1 week after wire placement (T0-T3)||||units on a scale||Standard Deviation|Mean
1334198|NCT02026258|Primary|Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index|Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.|From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months||||Days to complete alignment||Standard Deviation|Mean
1334199|NCT02026206|Secondary|Quality of Life|The secondary outcome measures were quality of life as assessed by the EQ-5D (minimun 0.00, maximum 1.00). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to EQ-5D equation formula. The higher values represent a better outcome.All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity and quality of life after the next menstruation started (pre-treatment score) using the EQ-5D questionnaire. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of quality of life after the next menstruation started (post-treatment score) using the EQ-5D questionnaire.|within 3 months after treatment||||units on a scale||Standard Deviation|Mean
1334200|NCT02026206|Primary|Dysmenorrheal Pain Severity|The primary outcome was menstrual pain intensity described using a 0-10 VAS scale (minimum 0, maximum 10). The higher values represent a worse outcome. All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity after the next menstruation started (pre-treatment score) using the VAS. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of pain intensity after the next menstruation started (post-treatment score) using the VAS.|within 3 months after treatment||||units on a scale||Standard Deviation|Mean
1334201|NCT02026193|Primary|Fetal Heart Activity 1 Month Post Embryo Transfer|Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer|1 month after embryo transfer||||participants with fetal heart activity|||Number
1334202|NCT02026141|Other Pre-specified|VAS Scores|Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark.|6, 12 and 24 hour marks.|||||||
1334203|NCT02026141|Secondary|Time of First Analgesia Request||time of first analgesia request from closure of skin up to 24 hours.|||||||
1334204|NCT02026141|Primary|Morphine Consumption|Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.|24 hours||||milligrams||Standard Deviation|Mean
1334205|NCT02025907|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
1334206|NCT02025907|Secondary|Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26||Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1334207|NCT02025907|Secondary|Percent Change From Baseline in Body Weight at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1334208|NCT02025907|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||millimoles per liter||Standard Error|Least Squares Mean
1334209|NCT02025907|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1334210|NCT02025829|Secondary|Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, and Neutrophil Elastase|In the Exacerbation/IV Antibiotics Cohort--Measurement of sputum inflammatory mediators by multiplex assay for IL-1β, IL-6, IL-8, and IL-17A. Neutrophil elastase determined by colorimetric assay. Measurements at the beginning of IV antibiotic treatment and after 2 weeks antibiotic treatment for a pulmonary exacerbation|End of Treatment, two weeks. Samples will be obtained from each study volunteer at the beginning of IV antibiotic treatment and at the completion of antibiotic treatment for a pulmonary exacerbation||||pg/ml||Standard Deviation|Mean
1334211|NCT02025829|Secondary|Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, TGF-β, TNF-α, and Neutrophil Elastase|In the Clinically Stable Cohort--Measurement of sputum inflammatory mediators: IL-1β, IL-6, IL-8, IL-17A, TGF-β, TNF-α, and neutrophil elastase|Samples will be obtained at one outpatient clinic visit during the next calendar year|Data not collected and will never be analyzed.||||||
1334212|NCT02025829|Primary|Change in Sputum IL-17 Neutrophils|In the Exacerbation/IV Antibiotics Cohort--Subjects will serve as their own controls. The percentage of neutrophils (in sputum) positive for IL-17 was determined by flow cytometry for each subject at the beginning and end of treatment for a pulmonary exacerbation. Sputum IL-17 neutrophil counts will be compared to the change in lung function (FEV1) as determined by spirometry (American Thoracic Society standards).|End of Treatment, two weeks. Samples will be obtained from each study volunteer at the beginning of IV antibiotic treatment and at the completion of antibiotic treatment for a pulmonary exacerbation|"Regarding Clinically Stable Arm: Because very few neutrophils at the end of treatment for a pulmonary exacerbation were positive for IL-17, it was determined not to undertake studies examining sputum neutrophils during periods of clinical stability."|||% of neutrophils positive for IL-17||Standard Deviation|Mean
1334213|NCT02025647|Post-Hoc|Mental Health Prevalence Rates Comparison|"What is the percentage of subjects where the provider was unaware of any mental health concerns yet Innerview identified them as having hit a rule out or diagnostic consideration for a mental health disorder vs the US 12 Month Prevalence Rate?~US 12 Month Prevalence Rate = 26.2% (http://www.ncbi.nlm.nih.gov/pubmed/15939839)"|Study Duration|104 subjects had no known mental health concerns|||percentage of subjects|||Number
1334214|NCT02025647|Other Pre-specified|Completion Times|On average, the number of minutes taken to complete both the narrative and rating modules?|Study Duration||||minutes||Inter-Quartile Range|Median
1334215|NCT02025647|Secondary|Subject Survey (Question 10)|It took an acceptable amount of time to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334216|NCT02025647|Secondary|Subject Survey (Question 9)|The demonstration showed me how to use the system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334217|NCT02025647|Secondary|Subject Survey (Question 8)|Telling my story helped me prepare for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334218|NCT02025647|Secondary|Subject Survey (Question 7)|Q7. I would encourage other doctors to use this system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334219|NCT02025647|Secondary|Subject Survey (Question 6)|"I was able to select words and phrases that I normally use to talk about my symptoms.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate||||units on a scale||Standard Deviation|Mean
1334220|NCT02025647|Secondary|Subject Survey (Question 5)|The program included all of the symptoms I wanted to share with my doctor. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334221|NCT02025647|Secondary|Subject Survey (Question 4)|This tool will contribute positively to my health care. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334222|NCT02025647|Secondary|Subject Survey (Question 3)|The program was easy to use. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
1334223|NCT02025647|Secondary|Subject Survey (Question 2)|"Compared to other health care questionnaires I have taken, I would rate this system highly.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate||||units on a scale||Standard Deviation|Mean
1334225|NCT02025647|Secondary|Provider Survey (Question 11)|On average, how much extra time do you estimate that you spent with your patients evaluating and discussing the information collected through Innerview?|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||minutes||Full Range|Mean
1334226|NCT02025647|Secondary|Provider Survey (Question 10)|The benefits of Innerview will outweigh the effort to implement and operate it. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334227|NCT02025647|Secondary|Provider Survey (Question 9)|In my opinion, incorporating Innerview into my practice would require an acceptable amount of time and effort from myself and staff Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334228|NCT02025647|Secondary|Provider Survey (Question 8)|My patients reacted positively to Innerview. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334229|NCT02025647|Secondary|Provider Survey (Question 7)|Innerview will function well within my current work flow Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects, one investigator did not respond to this item.|||units on a scale||Full Range|Mean
1334230|NCT02025647|Secondary|Provider Survey (Question 6)|"Innerview will help me better identify patients who suffer from a mental health concern.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334231|NCT02025647|Secondary|Provider Survey (Question 5)|"In my opinion, the Innerview narrative process will help prepare patients for treatment.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334232|NCT02025647|Secondary|Provider Survey (Question 4)|The information provided by Innerview was well communicated in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334233|NCT02025647|Secondary|Provider Survey (Question 3)|The information provided by Innerview was well organized in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334234|NCT02025647|Secondary|Provider Survey (Question 2)|"The information provided by Innerview was consistent with my previous observations of my patients.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334235|NCT02025647|Secondary|Provider Survey (Question 1)|"The information provided by Innerview is valuable in understanding and treating my patients.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
1334236|NCT02025647|Primary|Standard Error of Measure for the Individualized Rating Scale (Rating Module)|What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale|approximate 5 minutes between ratings||||units on a scale|||Number
1334237|NCT02025647|Primary|Reliability of the Narrative Module|What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?|24-48 hours||||percentage of agreement||Standard Deviation|Mean
1334238|NCT02025647|Primary|Accuracy of the Narrative Module|Out of 139 subjects using Innerview for the first time, how many subjects approved their initial version of their narrative versus chose to start over?|Immediate||||participants|||Number
1334239|NCT02025621|Other Pre-specified|Rehospitalization for Any Cause Through Day 30||30 days|patients receiving study drug, by study drug received|||Participants|||Count of Participants
1334242|NCT02025621|Secondary|Incidence of Low Cardiac Output Syndrome (LCOS)|Use of a mechanical cardiac assist device within 5 days after surgery, two consecutive measurements of low cardiac output (defined as a cardiac output of ≤2.0 liters per minute per square meter of bodysurface area), one measurement of low cardiac output plus the use of two or more inotropes at or beyond 24 hours after surgery, or the use of two or more inotropes at or beyond 24 hours after surgery with the indicated reason being low cardiac output.|5 days|mITT; patients receiving any study drug|||Participants|||Count of Participants
1334243|NCT02025621|Secondary|Duration of Intensive Care Unit/Critical or Coronary Care Unit (ICU/CCU) (Days)|Duration of intensive care unit/critical or coronary care unit (ICU/CCU) length of stay (LOS) in days|participants will be followed for during the participant's hospital stay up to 30 days|mITT; patients that received any study drug|||days||Inter-Quartile Range|Median
1334244|NCT02025621|Primary|Number of Quad Efficacy Endpoint Events|Composite of all-cause death (at 30 days), or perioperative nonfatal MI [CK-MB >10xULN or >100 ng/mL, CK-MB >5xULN or 50 ng/mL with new Q wave (>0.04 seconds wide in two contiguous leads) or new left bundle branch block)] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)|30 days|mITT; population receiving any study drug|||events|||Number
1334245|NCT02025621|Primary|Number of Dual Efficacy Endpoint Events|The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5|30 days|mITT; population receiving any study drug|||events|||Number
1334246|NCT02025075|Secondary|Postoperative Pain|The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as incisional pain using VAS (0 = no pain; 100 = worst possible pain).|Postoperative Day 1||||units on a scale||Standard Deviation|Mean
1334247|NCT02025075|Primary|Cerebral Oximetry (%)|Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum||||percent cerebral saturation||Standard Deviation|Mean
1334248|NCT02025075|Primary|Ejection Fraction (%)|To assess cardiac performance, transthoracic echocardiography will be used. Ejection fraction was measured as fractional shortening (FS). FS is the fraction of any diastolic dimension that is lost in systole. FS = 100*(LVEDD - LVESD) / LVEDD, LVEDD = LV end-diastolic dimension (mm); LVESD = LV end-systolic dimension (mm).|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum||||% fractional shortening||Standard Deviation|Mean
1334249|NCT02025075|Primary|Regional Change in Air Content (Delta Z, %)|We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6). Percent change was calculated using electrical impedance measurements obtained at time T0 as reference.|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum||||percent change||Standard Deviation|Mean
1334250|NCT02024971|Secondary|Change From Baseline in Fasting Insulin|Tabulation of fasting insulin test values and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).|||μU/dL||Standard Deviation|Mean
1334251|NCT02024971|Secondary|Change From Baseline in Fasting Blood Glucose|Tabulation of fasting blood glucose test values and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).|||mg/dL||Standard Deviation|Mean
1334252|NCT02024971|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of the HbA1c test value and change at each test time point (test value at each test time point after baseline – test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).|||percentage of HbA1c||Standard Deviation|Mean
1334253|NCT02024971|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety Analysis Set, all patients for whom data was collected in case report forms, except those who were treated before the contract period, those who were enrolled after Day 15 of the start of treatment with Metact Combination Tablets, and those with missing data after treatment (missed visits).|||participants|||Number
1334254|NCT02024932|Secondary|Compare Dose Normalized Log-transformed AUCinf Following IV and SC Administrations|Serum samples were obtained for PK assessment.|In Part A: days 1 and 15, pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
1340469|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1334255|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
1334256|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Terminal Elimination Half-life (T1/2)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
1334257|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
1334258|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 5||Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
1334259|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 4|Serum samples were obtained for the PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.|||H*ng/mL||Standard Deviation|Mean
1334260|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Day 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
1334261|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||hours||Standard Deviation|Mean
1334262|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 4|Serum samples were obtained for PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.|||hours||Standard Deviation|Mean
1334263|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
1334264|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 4|Serum samples were obtained for PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.|||ng/mL||Standard Deviation|Mean
1334265|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
1334266|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
1334267|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||H*ng/mL||Standard Deviation|Mean
1334268|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
1334269|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Day 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||hours||Standard Deviation|Mean
1334270|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||hours||Standard Deviation|Mean
1334271|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
1334272|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
1334273|NCT02024932|Secondary|Mean Change From Baseline in Total Lean Body Mass (LBM) in Part B, Cohort 5|LBM was assessed by dual-energy X-ray (DXA) absorptiometry. A positive change from baseline indicate improvement.|Baseline, Day 85|The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.|||kilograms||Standard Deviation|Mean
1334274|NCT02024932|Secondary|Mean Change From Baseline in Score on the Adult Myopathy Assessment Tool (AMAT) in Part B, Cohort 5|The AMAT rated physical function and muscle endurance, with higher scores indicating better performance. The tool includes 7 timed functional tasks rated on a scale from 0 - 21 and 6 endurance tasks rated on a scale from 0 - 24. The range for the total score was from 0 (worst) to 45 (best). A positive change from baseline indicates improvement.|Baseline, Day 85|The PD set included, which included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data, was analyzed.|||score on a scale||Standard Deviation|Mean
1334275|NCT02024932|Primary|Mean Percent Change From Baseline in Thigh Muscle Volume in Part B, Cohort 5|Thigh muscle volume was assessed by magnetic resonance imaging (MRI). Change from baseline was calculated from the ratio of the post-baseline mean value to the baseline mean value: [(Day 85/baseline) - 1)] x 100. A positive change from baseline indicates improvement.|Baseline, Day 85|The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.|||Percent change||Standard Deviation|Mean
1334276|NCT02024932|Primary|Number of Mild, Moderate and Severe Adverse Events as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|After 78 days in Part A and after 85 days in Part B.|The safety analysis set, which included participants who received any study drug, was analyzed.|||Participants|||Number
1334277|NCT02024932|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|After 78 days in Part A and after 85 days in Part B.|The safety analysis set, which included participants who received any study drug, was analyzed.|||Participants|||Number
1334278|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage||||participants|||Number
1334390|NCT02023151|Secondary|Changes in Syk Expression|Change in syk expression. Syk is a signaling molecule that is the first downstream event in IgE receptor activation of basophils.|baseline and 26 weeks||||fold change||Standard Deviation|Mean
1334279|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage||||participants|||Number
1334280|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage||||participants|||Number
1334281|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage||||participants|||Number
1334282|NCT02024867|Secondary|Recurrent Skin Infections|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage||||participants|||Number
1334283|NCT02024867|Primary|Treatment Failures|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage||||participants|||Number
1334284|NCT02024724|Primary|The Proportion of Subjects Reporting at Least 50% Overall Pain Relief|The number of subjects reporting a minimum of 50% pain relief after receiving the injection.|2 weeks|Subjects reported percent relief at 2 weeks from receiving the ultrasound guided injection.|||Participants|||Count of Participants
1334285|NCT02024698|Primary|Overall Satisfaction for Lens|"Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall? (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||participants|||Number
1334286|NCT02024698|Primary|Overall Sensation of Smoothness (Subjective Assessment)|"Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear? (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||participants|||Number
1334287|NCT02024698|Primary|Eye Whiteness/Redness (Subjective Assessment)|Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
1334288|NCT02024698|Primary|Handling (Subjective Assessment)|Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
1334289|NCT02024698|Primary|Dryness (Subjective Assessment)|Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
1334290|NCT02024698|Primary|Vision Satisfaction (Subjective Assessment)|Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
1334291|NCT02024698|Primary|Vision Quality (Subjective Assessment)|Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)|Baseline||||units on a scale||Standard Deviation|Mean
1334292|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
1334293|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|Baseline||||units on a scale||Standard Deviation|Mean
1334294|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
1334295|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|Baseline||||units on a scale||Standard Deviation|Mean
1334442|NCT02022085|Secondary|Numbness|Degree of numbness when tested with a pin|Day 10, Week 4, Week 6, Week 12, Month 6|Safety population; includes all patients who received the surgical intervention.|||percentage of total polulation|||Number
1334296|NCT02024386|Secondary|Cardiac Output|Arterial blood samples will be obtained before, during, and after the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Samples will be obtained during the fifth minute of rest prior to exercise, during the third minute of each exercise level (referred to as stage below) and during the fifth minute post exercise. Cardiac output (CO) will be calculated using the Fick Principle: CO = V̇O2/(CaO2 – Cv̄O2) where CaO2 and Cv̄O2 represent the arterial and mixed venous oxygen content, respectively. CaO2 and CvO2 will be determined from analysis of the arterial blood samples using an IL GEM 4000 analyzer. VO2 will be reported as the final 30 secon average value of each stage. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||L/min||Standard Deviation|Mean
1334297|NCT02024386|Secondary|Mean Work Rate at Exhaustion|Subject work rates at exhaustion (in watts) will be continuously monitored using an ergometer (exercise bicycle) during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||watts||Standard Deviation|Mean
1334298|NCT02024386|Secondary|Mean Ventilation Rate|Subject ventilation rates will be monitored continuously using a multi-channel A/D converter (PowerLab™) connected to a personal computer, using Chart™ software (ADInstruments, Colorado Springs, CO) during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||L/min||Standard Deviation|Mean
1334299|NCT02024386|Secondary|Mean Arterial Oxygen Saturation (SaO2)|Subject arterial oxygen saturation (SaO2) will be periodically monitored at fixed intervals via arterial blood gas measurements during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||% oxygen saturation||Standard Deviation|Mean
1334300|NCT02024386|Secondary|Mean Radial Arterial Pressure|Subject systemic arterial pressures will be continuously monitored via radial artery catheterization during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||mm Hg||Standard Deviation|Mean
1334301|NCT02024386|Primary|Mean Pulmonary Artery Pressure|Subject pulmonary artery pressures will be continuously monitored during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||mm Hg||Standard Deviation|Mean
1334302|NCT02024165|Primary|Fetal Heart Rate Interpretability|The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices|2 hours||||percentage of time the signals are inter||Standard Deviation|Mean
1334303|NCT02023983|Secondary|Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)|Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p < 0.05 were considered as statistically significant.|30 days||||Participants|||Count of Participants
1334304|NCT02023983|Primary|Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI)|Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p < 0.05 were considered as statistically significant.|90 days||||Participants|||Count of Participants
1334305|NCT02023918|Secondary|Lipolysis|Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.|28 days|Ra glycerol reported|||mg/kg/min||Standard Deviation|Mean
1334306|NCT02023918|Primary|Insulin Sensitivity|"Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR.~HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5"|28 days|Patients were compared after treatment to their own baseline|||units on a scale||Standard Deviation|Mean
1334307|NCT02023879|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase|Mean percent changes (and standard deviations) observed during the open-label extension period are provided.|Baseline, Week 32, 36, 48, 72, 96, 120, 144 and Week 168|Open-label extension population included all participants who received at least one dose or part of dose of Alirocumab during the open label extension period. Here, “number analyzed” signifies the number of participants evaluable for each specified time-point.|||percent change||Standard Deviation|Mean
1334308|NCT02023879|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
1334309|NCT02023879|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
1334310|NCT02023879|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1334311|NCT02023879|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1334312|NCT02023879|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334313|NCT02023879|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334314|NCT02023879|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1334315|NCT02023879|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1334316|NCT02023879|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 – On-treatment Analysis|Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percentage of participants|||Number
1334317|NCT02023879|Secondary|Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percentage of participants|||Number
1334318|NCT02023879|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 – On-treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percentage of participants|||Number
1334319|NCT02023879|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|"Moderate CV risk: 10-year fatal cardiovascular disease (CVD) risk Systemic Coronary Risk Evaluation (SCORE) ≥1 and <5%.~High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.~Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion >50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.~Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included."|From Baseline to Week 24|ITT population.|||percentage of participants|||Number
1334320|NCT02023879|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334321|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334322|NCT02023879|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
1334323|NCT02023879|Secondary|Percent Change From Baseline in Total-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334324|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 – On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
1334325|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334326|NCT02023879|Secondary|Percent Change From Baseline in Apo B at Week 24 – On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population. Number of participants analyzed = participants of the mITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
1334327|NCT02023879|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
1334328|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
1334329|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 – ITT- Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334330|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
1334331|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1334332|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1334333|NCT02023879|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1334334|NCT02023866|Secondary|Change From Baseline in Modified Lansky Play Performance Scale|"The investigator selected the 2 most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms were assessed at each subsequent study visit.~Reduced activities of daily living was assessed using the modified Lansky Play Performance Scale, completed by parents based on their child’s activity in the past week, where 100=fully active; 90=minor restrictions in strenuous physical activity; 80=active, gets tired more quickly; 70=greater restriction of play, less time spent in play activity; 60=up and around, active play minimal; quieter activities; 50=lying around much of the day; no active playing, all quiet play and activities; 40=mainly in bed; quiet activities; 30=bedbound; needs assistance even for quiet play; 20=sleeps often; play limited to very passive activities; 10=doesn't play or get out of bed; 5=unresponsive 0=dead"|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline Lansky play performance scale assessment and for whom reduced activities of daily living was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
1334443|NCT02022085|Secondary|Pain|Degree of pain and discomfort.|Week 6, Week 12, Month 6|Safety population; includes all patients who received the surgical intervention.|||percentage of total population|||Number
1334335|NCT02023866|Secondary|Change From Baseline in Gross Motor Function|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Retarded motor development was assessed using the Gross Motor Function Measure (GMFM)-88 which consists of 88 items scored on a scale of 0 to 3:~0: Does not initiate the task;~Initiates the task (completes < 10%);~Partially completes the task (10 to 99%);~Completes the task (100%).~The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Scores are expressed as a percentage of the maximum score for that dimension. The total score is the average of the 5 the percentage scores where higher scores indicate better performance."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline gross motor function assessment and for whom retarded motor development was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
1334336|NCT02023866|Secondary|Change From Baseline in Friedreich Ataxia Rating Scale|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Ataxia was assessed using the Friedreich Ataxia Rating Scale (FARS). FARS comprises a functional ataxia staging score of overall mobility (score 0 to 6), an assessment of the activities of daily living (ADL) (score 0 to 36) and a neurological assessment (score from 0 to 117) which is composed of bulbar (score 0-11), upper limb (score 0- 36) and lower limb (score 0-16), peripheral nerve (score 0-26) and upright stability/gait (score 0-28). The scores were summed to calculate the total score which ranges from 0 to 159. A higher score indicates a greater level of disability."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline ataxia assessment and for whom ataxia was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
1334337|NCT02023866|Secondary|Change From Baseline in Barry-Albright Dystonia Scale Total Score|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Dystonia symptoms were assessed using the Barry-Albright Dystonia Scale for Dystonia. Participants were assessed for dystonia in each of the following regions: eyes, mouth, neck, trunk, and each upper and lower extremity (8 body regions) on a scale from 0 (absent) to 4 (severe symptoms). The individual scores were summed to calculate the total score which ranges from 0 (dystonia absent) to 32 (severe dystonia)."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline dystonia assessment and for whom dystonia was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
1334338|NCT02023866|Secondary|Change From Baseline in Jamar Dynamometer Hand Strength|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Myopathy was assessed using standard grip strength evaluation, which measures hand strength in both hands using a Jamar dynamometer."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline Jamar hand strength assessment and for whom myopathy was prespecified as a preeminent symptom and with available data at each time point.|||kg||Standard Deviation|Mean
1334339|NCT02023866|Secondary|Change From Baseline in 6 Minute Walk Test|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: Myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Myopathy was assessed using the 6 minute walk test, which measures the distance walked in a 6 minute walk test."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline 6 minute walk test assessment and for whom myopathy was prespecified as a preeminent symptom and with available data at each time point.|||meters||Standard Deviation|Mean
1334340|NCT02023866|Secondary|Change From Baseline in Lactic Acid||Baseline and Weeks 4, 8, 12, 16, 20, 24|PD analysis set participants with available data at each time point.|||mmol/L||Standard Deviation|Mean
1334341|NCT02023866|Secondary|Change From Baseline in Glutathione Disulfide||Baseline and Weeks 4, 8, 12, 16, 20, 24|PD analysis set participants with available data at each time point.|||µmol/L||Standard Deviation|Mean
1334342|NCT02023866|Secondary|Change From Baseline in Glutathione||Baseline and Weeks 4, 8, 12, 16, 20, 24|The pharmacodynamic (PD) analysis set included all participants who received at least one dose of study drug and had at least one post-baseline PD assessment. Participants with available data at each time point are included in the analysis.|||µmol/L||Standard Deviation|Mean
1334343|NCT02023866|Primary|Change From Baseline in Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Sections I-IV|"The NPMDS evaluates the progression of mitochondrial disease in pediatric patients in 4 domains:~I - Current Function (vision, hearing, communication, feeding, and mobility) with scores ranging from 0 to 21; II -System Specific Involvement (seizures, encephalopathy, bleeding diathesis or coagulation defects, gastrointestinal, endocrine, respiratory, cardiovascular, renal, liver, and blood) with scores ranging from 0 to 30.~III - Current Clinical Assessment (growth and development over past 6 months, vision, strabismus and eye movement, myopathy, ataxia, pyramidal, extrapyramidal, and neuropathy) with scores ranging from 0 to 28; and IV - Quality of Life with scores ranging from 0 to 25. For sections I-III, higher scores reflect more severe disease. For Section IV, a higher score reflects a lower quality of life."|Baseline through Week 24|Completers Analysis Set included all participants who received at least one dose of study drug (RP103) with at least one post-baseline NPMDS assessment and an evaluable Week 24 NPMDS assessment within the protocol specified window.|||units on a scale||Standard Deviation|Mean
1334344|NCT02023801|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 months|Protocol Intent-to-treat|||participants|||Number
1334346|NCT02023801|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)|||participants|||Number
1334347|NCT02023697|Other Pre-specified|Number of Participants With Change in Analgesic Use From Baseline to Worst Status Post-Baseline|Analgesic use in this study were captured via two methods: Analgesic concomitant medication case report form, where the physician records the analgesic medication prescribed to manage pain; 24 hour analgesic consumption case report form, in which all analgesic medication taken in the last 24 hours.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)||||Participants|||Count of Participants
1334348|NCT02023697|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Treatment-emergent adverse events are events starting or worsening from the initiation of treatment until 30 days after the last administration of radium-223 dichloride. The intensity of an AE is classified according to the grades specified by the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Safety Analysis Set|||Participants|||Count of Participants
1334349|NCT02023697|Secondary|Time to Pain Progression - Three Dose Groups as Randomized|The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
1334350|NCT02023697|Secondary|Number of Participants With a Pain Progression Event - Three Dose Groups as Randomized|Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
1334351|NCT02023697|Secondary|Time to Pain Progression - Extended Dose vs. Standard Dose|The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
1334352|NCT02023697|Secondary|Number of Participants With a Pain Progression Event – Extended Dose vs. Standard Dose|Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
1334353|NCT02023697|Secondary|Time to Pain Progression – High Dose vs. Standard Dose|The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
1334354|NCT02023697|Secondary|Number of Participants With a Pain Progression Event – High Dose vs. Standard Dose|Participants were divided in 3 groups according to baseline pain evaluation: asymptomatic subjects (WPS 0 to < 1 at baseline); mildly symptomatic subjects (WPS 1-3 at baseline); and symptomatic subjects with WPS > 3 and ≤ 7 at baseline). Pain progression was defined as the occurrence of a pain increase of 2 or more points in the average (i.e., average of 7-day assessments) “worst pain in 24 hours” score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart. Participants with insufficient applicable baseline assessments or without adequate post-baseline assessments were to be censored at the applicable baseline date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
1334355|NCT02023697|Secondary|Timepoint Pain Improvement Rate - Extended Dose vs. Standard Dose|Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||percentage||80% Confidence Interval|Number
1334356|NCT02023697|Secondary|Timepoint Pain Improvement Rate - Three Dose Groups as Randomized|Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||percentage||80% Confidence Interval|Number
1334387|NCT02023515|Secondary|Decrease in Stress|Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers.|PSS change from baseline to 20 weeks||||units on a scale||90% Confidence Interval|Mean
1334388|NCT02023515|Primary|Weight Loss|Weight change from baseline to 20 weeks|Weight change from baseline to 20 weeks||||kg||Standard Deviation|Mean
1334357|NCT02023697|Secondary|Time to Radiological Progression - Three Dose Groups as Randomized|Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
1334358|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event - Three Dose Groups as Randomized|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
1334359|NCT02023697|Secondary|Time to Radiological Progression - Extended Dose vs. Standard Dose|Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
1334360|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event – Extended Dose vs. Standard Dose|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
1334361|NCT02023697|Secondary|Time to Radiological Progression – High Dose vs. Standard Dose|Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
1334362|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event – High Dose vs. Standard Dose|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
1334363|NCT02023697|Secondary|Radiological Progression Free Survival - Three Dose Groups as Randomized|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
1334364|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event-Free - Three Dose Groups as Randomized|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
1334365|NCT02023697|Secondary|Radiological Progression Free Survival - Extended Dose vs. Standard Dose|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Baseline is radomization date|||months||80% Confidence Interval|Median
1334366|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event-Free – Extended Dose vs. Standard Dose|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Baseline is radomization date|||Participants|||Count of Participants
1334367|NCT02023697|Secondary|Radiological Progression Free Survival – High Dose vs. Standard Dose|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
1334368|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event-Free – High Dose vs. Standard Dose|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans. Radiological bone progression is determined if at least one of the following criteria is met: The first bone scan with ≥2 new lesions compared to baseline is observed <12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); or The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline).|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
1334369|NCT02023697|Secondary|Time to First Symptomatic Skeletal Event - Three Dose Groups as Randomized|Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
1334370|NCT02023697|Secondary|Number of Participants With First Symptomatic Skeletal Event - Three Dose Groups as Randomized|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
1334371|NCT02023697|Secondary|Time to First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose|Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
1334372|NCT02023697|Secondary|Number of Participants With First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
1334373|NCT02023697|Secondary|Time to First Symptomatic Skeletal Event - High Dose vs. Standard Dose|Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
1334374|NCT02023697|Secondary|Number of Participants With First Symptomatic Skeletal Event - High Dose vs. Standard Dose|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
1334375|NCT02023697|Secondary|Overall Survival Event - Three Dose Groups as Randomized|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
1334376|NCT02023697|Secondary|Number of Participants With an Overall Survival - Three Dose Groups As Randomized|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
1334389|NCT02023268|Primary|Global Ocular Staining (With Oxford Scale - Ranges : 0-15)|"Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)~Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed)."|Baseline and Day 35|14 patients with major protocol deviations were excluded of the analysed population.|||score on a scale||Standard Deviation|Mean
1334377|NCT02023697|Secondary|Overall Survival - Extended Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
1334378|NCT02023697|Secondary|Number of Participants With an Overall Survival Event - Extended Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
1334379|NCT02023697|Secondary|Overall Survival - High Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
1334380|NCT02023697|Secondary|Number of Participants With an Overall Survival Event - High Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
1334381|NCT02023697|Primary|Symptomatic Skeletal Event Free Survival - Three Dose Groups As Randomized|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
1334382|NCT02023697|Primary|Number of Participants With an Event Defining SSE Free Survival - Three Dose Groups As Randomized|Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
1334383|NCT02023697|Primary|Symptomatic Skeletal Event-Free Survival - Extended Dose vs. Standard Dose|In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
1334384|NCT02023697|Primary|Number of Participants With an Event Defining SSE Free Survival - Extended Dose vs. Standard Dose|Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24): All ITT participants in Arm A (standard dose) and Arm C (extended dosing) treated with radium-223 dichloride and eligible for further treatment at W24 (i.e., 7th injection). All participants who received 6 doses from Arm A and participants who received >=6 doses from Arm C were included .|||Participants|||Count of Participants
1334385|NCT02023697|Primary|Symptomatic Skeletal Event-Free Survival - High Dose vs. Standard Dose|In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Intent-to-treat (ITT): All randomized participants. Data from Arm C are truncated at 7th dose date when pooling with Arm A, therefore Pooled Arm A+C included 261 participants.|||months||80% Confidence Interval|Median
1334386|NCT02023697|Primary|Number of Participants With an Event Defining SSE Free Survival - High Dose vs. Standard Dose|Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Intent-to-treat (ITT): All randomized participants. Data from Arm C are truncated at 7th dose date when pooling with Arm A, therefore Pooled Arm A+C included 261 participants.|||Participants|||Count of Participants
1334391|NCT02023151|Primary|Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab|Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response|baseline and 26 weeks||||Fold change in basophil Syk expression||Standard Deviation|Mean
1334392|NCT02023125|Secondary|Vz/F for Alectinib: Group 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||Liters||Standard Deviation|Mean
1334393|NCT02023125|Secondary|Apparent Volume of Distribution (Vz/F) for Alectinib: Group 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||Liters||Standard Deviation|Mean
1334394|NCT02023125|Secondary|CL/F for Alectinib: Group 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||L/h||Standard Deviation|Mean
1334395|NCT02023125|Secondary|Apparent Oral Clearance (CL/F) for Alectinib: Group 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||Liters per hour (L/h)||Standard Deviation|Mean
1334396|NCT02023125|Secondary|t1/2 of RO5468924: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Standard Deviation|Mean
1334397|NCT02023125|Secondary|t1/2 of RO5468924: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Group 1]|||hours||Standard Deviation|Mean
1334398|NCT02023125|Secondary|t1/2 of Alectinib: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Standard Deviation|Mean
1334399|NCT02023125|Secondary|Terminal Half-life (t1/2) of Alectinib: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours||Standard Deviation|Mean
1334400|NCT02023125|Secondary|Tmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Full Range|Median
1334401|NCT02023125|Secondary|Tmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours||Full Range|Median
1334402|NCT02023125|Secondary|Tmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Full Range|Median
1334403|NCT02023125|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours||Full Range|Median
1334404|NCT02023125|Secondary|AUClast of RO5468924: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
1334405|NCT02023125|Secondary|AUClast of RO5468924: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||h*ng/mL||Standard Deviation|Mean
1334406|NCT02023125|Secondary|AUClast of Alectinib: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
1334407|NCT02023125|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||h*ng/mL||Standard Deviation|Mean
1334408|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||ratio||Standard Deviation|Geometric Mean
1334493|NCT02021643|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||Participants|||Count of Participants
1334409|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||ratio||Standard Deviation|Geometric Mean
1334410|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
1334411|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||h*ng/mL||Standard Deviation|Mean
1334412|NCT02023125|Secondary|Cmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||ng/mL||Standard Deviation|Mean
1334413|NCT02023125|Secondary|Cmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||ng/mL||Standard Deviation|Mean
1334414|NCT02023125|Primary|AUC0-inf of Alectinib: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
1334415|NCT02023125|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Alectinib: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
1334416|NCT02023125|Primary|Cmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||ng/mL||Standard Deviation|Mean
1334417|NCT02023125|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|Pharmacokinetic (PK) Analysis Population [Group 1] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1334418|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse Within Different Subpopulations|"The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm."|within 12 weeks after the last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation.|||percentage of participants|||Number
1334419|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations|"The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment)."|12 or 16 weeks (end of treatment period)|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.|||percentage of participants|||Number
1334420|NCT02023112|Secondary|Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations|The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.|12 weeks after last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.|||percentage of participants||95% Confidence Interval|Number
1334421|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse|Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.|within 12 weeks after the last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug) with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||percentage of participants|||Number
1334422|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period|On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).|12 or 16 weeks (end of treatment period)|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
1334423|NCT02023112|Primary|Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
1334424|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA < 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A); n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).|||percentage of participants||95% Confidence Interval|Number
1334425|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).|||percentage of participants||95% Confidence Interval|Number
1334426|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation|"Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT.~Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method."|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).|||percentage of participants||95% Confidence Interval|Number
1334427|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Post-treatment Relapse|Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method.|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).|||percentage of participants||95% Confidence Interval|Number
1334428|NCT02023099|Secondary|Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation|On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method.|up to 12 weeks|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A).|||percentage of participants||95% Confidence Interval|Number
1335901|NCT01998360|Secondary|Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks|The number of participants with complete epithelialization (completely healed) at 4 weeks|1 month||||participants|||Number
1334429|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment|"On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following:~confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point during treatment after HCV RNA < LLOQ (rebound), or~confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during treatment (rebound), or~HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment (failure to suppress).~The 95% confidence interval was calculated using the Wilson's score method."|up to 12 weeks|Intent-to-treat (ITT) population: randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).|||percentage of participants||95% Confidence Interval|Number
1334430|NCT02023099|Primary|Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment|The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution.|12 weeks after the last dose of study drug|Primary Efficacy Population: randomized non-cirrhotic treatment-naïve participants who are eligible for interferon-based therapy and who have high viral load and received at least one dose of double-blind ABT-450/r/ABT-267.|||percentage of participants||95% Confidence Interval|Number
1334431|NCT02022826|Secondary|Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis|Agreement between Gastric emptying time of SmartPill capsule (GET>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (>35% = severe)|an expected average of two weeks from study procedure||||percentage of agreement||95% Confidence Interval|Number
1334432|NCT02022826|Primary|Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis|Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET >5 hours) and the non-reference standard, gastric Emptying scintigraphy test (>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis|an expected average of two weeks from study procedure||||percentage of agreement||95% Confidence Interval|Number
1334433|NCT02022748|Secondary|Pharmacokinetic Parameter t1/2 of AR-C124910XX||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||hour||Standard Deviation|Mean
1334434|NCT02022748|Secondary|Pharmacokinetic Parameter t1/2 of Ticagrelor||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||hour||Standard Deviation|Mean
1334435|NCT02022748|Primary|Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334436|NCT02022748|Primary|Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334437|NCT02022748|Primary|Pharmacokinetic Parameter Cmax of AR-C124910XX||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334438|NCT02022748|Primary|Pharmacokinetic Parameter Cmax of Ticagrelor||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The Pharmacokinetic (PK) analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334439|NCT02022670|Secondary|Baseline and Week 10 Aortic Pulse Wave Velocity||Baseline (Week 0), Week 10||||cm/sec||Standard Error|Mean
1334440|NCT02022670|Secondary|Baseline and Week 10 Plasma Nitrite Concentrations||Baseline (Week 0), Week 10||||micromolar||Standard Error|Mean
1334441|NCT02022670|Primary|Baseline and Week 10 Flow-Mediated Dilation|Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.|Baseline (Week 0), Week 10||||%Change||Standard Error|Mean
1334444|NCT02022085|Secondary|Sound Processor Magnet Choice|To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.|4, 6, 12 weeks, 6 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6 one patient had left the study.|||participants|||Number
1334445|NCT02022085|Secondary|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|4, 6, 12 weeks, 6 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention.|||Newton||Standard Deviation|Mean
1334446|NCT02022085|Secondary|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability|Visit 2 (surgery)|Intention-to-treat (ITT) population; includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
1334447|NCT02022085|Secondary|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm|Visit 2 (surgery)|Intention-to-Treat (ITT) population; all patients who received surgical intervention.|||participants|||Number
1334448|NCT02022085|Secondary|Time to Perform Surgery|Time of first incision to time of last suture|Visit 2 (Surgery)|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||Minutes||Standard Deviation|Mean
1334449|NCT02022085|Secondary|Speech, Spatial and Qualities of Hearing Scale (SSQ)|"Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pe-operative unaided situation. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing."|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.|||units on scale||Standard Deviation|Mean
1334450|NCT02022085|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pe-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||units on scale||Standard Deviation|Mean
1334451|NCT02022085|Secondary|Health Utility Index (HUI)|Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||units on a scale||Standard Deviation|Mean
1334452|NCT02022085|Secondary|Speech in Quiet, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||Change of % correct words at the dB leve||Standard Deviation|Mean
1334453|NCT02022085|Secondary|Adaptive Speech Recognition in Noise, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive speech recognition in noise measured as signal to noise ratio|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.|||dB||Standard Deviation|Mean
1334454|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry Individual Frequencies, Sound Processor on Softband Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a softband before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies"|Baseline before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
1334455|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry PTA4, Sound Processor on Softband Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
1334456|NCT02022085|Secondary|Speech in Quiet, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||Change of % correct words at the dB leve||Standard Deviation|Mean
1334457|NCT02022085|Secondary|Adaptive Speech Recognition in Noise, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.|||dB||Standard Deviation|Mean
1334458|NCT02022085|Secondary|Hearing Performance; Threshold Audiometry Individual Frequencies, Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies"|Baseline before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
1335223|NCT02009722|Secondary|Treatment for Pruritus|The number of patients needing medical treatment for pruritus in first 24 hours after surgery|First 24 hours after spinal|only patients receiving most commonly used doses of IT hydromorphone (50,75,100 mcg) and morphine (100,150 mcg)|||participants|||Number
1334459|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 24 months after surgery|||||||
1334460|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)|Baseline before surgery, 12 months after surgery|||||||
1334461|NCT02022085|Primary|Hearing Performance; Threshold Audiometry PTA4, Unaided Versus Baha Attract|The change of hearing performance with the Baha Attract System (aided) at 6 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).|Baseline before surgery, 6 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
1334462|NCT02022020|Primary|Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation|Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).|||Percentage of participants|||Number
1334463|NCT02022020|Primary|Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge|Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).|||Percentage of participants|||Number
1334464|NCT02022020|Primary|Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge|"Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release.~Emergency Department/Room (ED/ER).~Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:~Ongoing, if symptoms of bleeding not completely resolved at time of discharge;~Deceased in case of death;~Resolved otherwise."|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).|||Percentage of participants|||Number
1334465|NCT02022007|Other Pre-specified|Number of Participants With No Clinically Significant Changes in Liver Enzyme Levels or Positive Pregnancy Tests|The safety criteria will include laboratory values for liver enzymes and document the absence of pregnancy in all participants during the trial|16 weeks||||Participants|||Count of Participants
1334466|NCT02022007|Secondary|Free Androgen Index (FAI)|Hyperandrogenism is measured by a combination of total testosterone (T) and sex hormone binding globulin (SHBG). The FAI was calculated as the quotient 100 x T/SHBG; hyperandrogenism was defined by a FAI value >3.85.|16 weeks||||index||Standard Deviation|Mean
1334467|NCT02022007|Secondary|Triglyceride (TRG) /HDL-cholesterol Ratio|The measure of TRG levels and HDL- cholesterol levels are used as an estimate of insulin sensitivity. A TRG/HDL-C ratio of greater than 3.0 is used as an indirect measure of insulin resistance|16 weeks||||Ratio||Standard Deviation|Mean
1334468|NCT02022007|Secondary|Menstrual Cycle Interval at 16 Weeks|The number of menstrual cycles during the previous year was recorded and the average menstrual interval calculated by dividing 365 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 16 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 112 days by the number of menstrual cycles recorded in each patient’s menstrual cycle diary.|16 weeks||||days between menstrual cycles||Standard Deviation|Mean
1334469|NCT02022007|Secondary|Waist Circumference at 16 Weeks|The circumference measurement was taken in the upright position using a 15-mm width flexible metric tape held close to the body but not tight enough to indent the skin. Waist circumference (WC) was measured in centimeters at the narrowest level midway between the lowest ribs and the iliac crest.|16 weeks||||centimeters||Standard Deviation|Mean
1334470|NCT02022007|Secondary|Body Mass Index at 16 Weeks|Height and weight measurements were used to calculate body mass index (BMI), defined as kg/m2.|16 weeks||||kg/mg2||Standard Deviation|Mean
1334471|NCT02022007|Secondary|Pancreatic ß-cell Compensatory Function|Post-treatment corrected early phase insulin secretion index (IGI/HOMA-IR). . Early pancreatic β-cell response is estimated as the insulinogenic index (IGI) derived from the ratio of the increment of insulin to that of glucose 30 minutes after a glucose load (insulin 30 min − insulin 0 min/glucose 30 min − glucose 0 min) corrected for by the relative level of insulin resistance (IGI/HOMA-IR which is estimated by homeostasis model assessment of insulin resistance using fasting insulin and glucose levels).|16 weeks||||Ratio||Standard Deviation|Mean
1334472|NCT02022007|Secondary|Matsuda Index of Insulin-Sensitivity (SI OGTT)|Post-treatment insulin sensitivity index. The Matsuda index of whole-body insulin sensitivity is calculated from an oral glucose tolerance test (10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during OGTT]), and is highly correlated with the rate of whole-body glucose disposal during the euglycemic insulin clamp|16 weeks||||Index||Standard Deviation|Mean
1334473|NCT02022007|Secondary|Mean Blood Glucose During the OGTT|Post-treatment mean blood glucose levels. Mean blood glucose (MBG) concentrations were calculated by summing glucose values obtained at 0,30,60 and 120 minutes during the OGTT and dividing by 4.|16 weeks||||mmol/L||Standard Deviation|Mean
1334474|NCT02022007|Secondary|Fasting Glucose|Post-treatment fasting glucose levels|16 weeks||||mmol/L||Standard Deviation|Mean
1334475|NCT02022007|Primary|Oral Disposition Index|Post-treatment in insulin-sensitivity-secretion index . The insulin secretion-sensitivity index (IS-SI) provides an estimate of β-cell compensation relative to the prevailing insulin resistance, not absolute insulin secretion. It is derived by applying the concept of the disposition index (DI) to measurements obtained during the 2-h OGTT. The IS-SI, a surrogate measure of the DI derived from the OGTT (IGI multiplied by the SIOGTT], was calculated as the product of acute β-cell response [IGI] and Matsuda index (SIOGTT) based on the existence of the predicted hyperbolic relationship between these two measures|16 weeks||||index||Standard Deviation|Mean
1334476|NCT02022007|Primary|Glucose Metabolism|Glucose metabolic secretory status after drug treatment (normal, impaired or diabetic). We used the American Diabetes Association (ADA) definition of impairment which is fasting glucose greater than 100 mg/dL and/or 2 hour glucose greater than 140 mg/dL.|16 weeks|Change from impaired to normal was evaluated. No patients were diabetic at the start or completion of the study|||Participants|||Count of Participants
1334477|NCT02021942|Other Pre-specified|Health Related Quality of Life|"Health related quality of life information was collected at Baseline and EOS using SF-36 questionnaire. Questionnaires had to be completed by the patients. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.~Patient reported answers were transformed into domain scores according to the guidelines provided by RAND/MOS. Statistical significance of the result was tested with a paired Wilcoxon rang sum test with a significance level of 0.05 considering only paired values (n=11) using PSPP Version 0.10.1."|at least 6 months|5 out of 16 patients were excluded from analysis due to missing EOS data.|||units on a scale||Standard Deviation|Mean
1334478|NCT02021942|Other Pre-specified|Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations|MG severity status is assessed by measuring ACHR-antibody concentrations at Baseline and EOS.|at least 6 months||||Participants|||Count of Participants
1334479|NCT02021942|Other Pre-specified|Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status|MG severity status is assessed by determining Titin-antibody status at Baseline and EOS.|at least 6 months||||Participants|||Count of Participants
1334480|NCT02021942|Other Pre-specified|Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)||at least 6 months||||Participants|||Count of Participants
1334481|NCT02021942|Secondary|Assessment of Tumor Operability|Assessment if patients reaching operability at the EOS.|at least 6 months|"Operability of the tumor at the EOS was based on the decision of the treating surgeon. In addition the response criteria had to be fulfilled.~The tumors of 11 patients (68.75%) were operable. One of these patients decided not to undergo surgery. Tumors of 5 patients were inoperable (31.25%) at the EOS."|||Participants|||Count of Participants
1334482|NCT02021942|Secondary|Tumor Resection Status|"To evaluate the resection status based on the categories R0, R1 and ≥ R2 at EOS using CT or MRI imaging.~R0 resection means no residual tumor tissue (best status); R1 indicates microscopic residual tumor tissue and R2 indicates macroscopic residual tumor tissue (worst status)."|at least 6 months||||Participants|||Count of Participants
1334483|NCT02021942|Primary|Percent Change in Tumor Volume From Baseline to EOS|To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume. Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. Tumor shrinkage is assessed by CT or MRI.|at least 6 months|Initial diagnosis of thymoma for one patient could not be confirmed, but a squamous cell carcinoma was diagnosed by the central pathologist. Tumor voume was 320.99 cm^3 at screening. Tumor size was reduced to 176.87 cm^3 at month 2 (-44.9 % compared to baseline). At month 4 (EOS) tumor volume was slightly increased compared to month 2 (189 cm^3).|||percentage of tumor volume||95% Confidence Interval|Mean
1334484|NCT02021812|Secondary|Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab|Device-related endoelaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the adjacent tissue (endoleak type IA or IB) OR the junction between the Aortic Component and either the SB Component or the Aortic Extender (type III endoleak).|1 month post procedure|1 participant was not assessed at 1 Month|||Participants|||Count of Participants
1334485|NCT02021812|Secondary|Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab||1 month post procedure||||Participants|||Count of Participants
1334486|NCT02021812|Primary|Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography|The presence of forward flow through the implanted Side Branch Component into the target branch vessel.|At conclusion of the treatment procedure (day 0)||||Participants|||Count of Participants
1334487|NCT02021812|Primary|Number of Participants With Successful Study Device Deployment|Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.|During treatment procedure (day 0)||||Participants|||Count of Participants
1334488|NCT02021812|Primary|Number of Participants With Successful Study Device Access|Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.|During treatment procedure (day 0)||||Participants|||Count of Participants
1334489|NCT02021643|Secondary|Change From Baseline in HCV RNA (log10 IU/mL)||Up to 24 weeks|Participants in the Full Analysis Set with available data were analyzed|||log10 IU/mL||Standard Deviation|Mean
1334490|NCT02021643|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Full Analysis Set|||Participants|||Count of Participants
1334491|NCT02021643|Secondary|Percentage of Participants With On-Treatment Virologic Failure|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.|Up to 24 weeks|Full Analysis Set|||Participants|||Count of Participants
1334492|NCT02021643|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1334494|NCT02021643|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who enrolled in the study and received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1334495|NCT02021565|Secondary|Caregiver Burden|Zarit Burden Interview Revised -indicating caregiver burden. Caregivers endorse 22 items using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores reflect greater caregiver burden. Scores range from 0 to 88.|T1 Baseline and T2 Post Intervention; 4-6 Weeks|Composite caregiver burden reported by informal caregiver. Ten caregivers from the Intervention group and seven caregivers from the Control group did not complete T2 and their data was not analyzed.|||units on Zarit Burden scale||Standard Deviation|Mean
1334496|NCT02021565|Secondary|Veteran Task Efficacy|Veteran care recipient reported confidence in the performance of 10 activity of daily living tasks rated on scale of 1-10. Items are assessed for efficacy with and without (independently) assistance provided from a caregiver. Scores range from 10-100 with higher scores reflecting greater task efficacy.|T1 baseline and T2 Post Intervention; 4-6 weeks|Veteran care recipient reported efficacy in performing transfer tasks with assistance from informal caregiver and independently. One Veteran from the Intervention group did not complete T2 and their data were not analyzed.|||units on a scale||Standard Deviation|Mean
1334497|NCT02021565|Primary|Caregiver Transfer Efficacy|Caregiver reported the level of confidence that Veteran care recipient can perform 10 activity of daily living tasks rated on scale of 1-10. Efficacy in task completion reported both with assistance from the informal caregiver and performed independently by the Veteran. Scores range from 10-100 with higher scores reflecting greater transfer efficacy.|T1 Baseline and T2 Post Intervention; 4-6 Weeks|Caregivers who reported their Veteran care recipient performed transfer tasks with assistance from informal caregiver. Two caregivers from the Intervention group and four caregivers from the Control group did not complete T2 and their data was not analyzed.|||units on a scale||Standard Deviation|Mean
1334498|NCT02021461|Primary|Assessment of Taste Preference|Subject preference for 3 flavours of the ESL oral suspension was assessed based on a measured score using a 0-10 cm (minimum and maximum measured values) Visual Analogue Scale (VAS). Higher values represent the stronger preference.|single Study Day||||units on a scale (0-10 cm VAS)||Standard Deviation|Mean
1334499|NCT02021331|Other Pre-specified|Bony Dimensional Changes|Measurements will be based off of standardized x-rays and CBCT.|Baseline, 6mo & 12mo after baseline|Data was not collected||||||
1334500|NCT02021331|Secondary|Implant Survival|Checking to make sure the implant is stable.|2wk, 4wk, 6wk, 3mo, 6mo, 12mo||||Participants|||Count of Participants
1334501|NCT02021331|Primary|Soft Tissue Diemensional Change|Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.|Baseline, 12mo after baseline|Data was not collected.||||||
1334502|NCT02021292|Post-Hoc|Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Excluding Subjects With Incorrect Hemodynamic Values.|The main analysis of the primary efficacy endpoint of PVR has been repeated excluding 4 subjects (3 macitentan, 1 placebo) with incorrect PVR values. The corrected hemodynamic values were reported after the clinical database closure (see post-hoc analysis 1 above). The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.|From baseline to Week 16|Modified full analysis set|||Percent of baseline PVR||95% Confidence Interval|Geometric Mean
1334503|NCT02021292|Post-Hoc|Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Including Subjects With Corrected Hemodynamic Values.|The main analysis of the primary efficacy endpoint of PVR has been repeated using the corrected hemodynamic values reported after the clinical database closure for 4 subjects (3 macitentan, 1 placebo). The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.|From baseline to Week 16|Full analysis set|||Percent of baseline PVR||95% Confidence Interval|Geometric Mean
1334504|NCT02021292|Secondary|Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24|"WHO functional classes are defined as follows: 1) class I: no symptoms with exercise or at rest. No limitation of activity. 2) class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). 3) class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. 4) class IV: symptoms at rest (such as dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms (e.g. may faint especially while bending over with their heads lowered). Patients in class IV manifest signs of right heart failure.~Shifting to a higher class (e.g. from class III to class IV) represents a 'worsening' while shifting to a lower class (e.g. from class III to class II) means an 'improvement'."|From baseline to Week 24|Full analysis set|||Participants|||Count of Participants
1334505|NCT02021292|Secondary|Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).|This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 24 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 (‘Nothing at all’) to 10 (‘Very, very severe – maximal’). A decrease in the Borg dyspnea index indicates an improvement.|From baseline to Week 24|Full analysis set|||Score on a scale||Standard Deviation|Mean
1334506|NCT02021292|Secondary|Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).|The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|From baseline to Week 24|Full analysis set|||meter||Standard Deviation|Mean
1334507|NCT02021292|Primary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.|The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.|From baseline to Week 16|Full analysis set|||percent of baseline PVR||95% Confidence Interval|Geometric Mean
1335224|NCT02009722|Secondary|Treatment for Nausea|number of patients needing medication treatment for nausea in first 24 hours|First 24 hours|patients receiving most commonly used doses of IT medication (50,75,100 mcg for hydromorphone; 100, 150 mcg for morphine)|||participants|||Number
1334508|NCT02021071|Secondary|Fluoroscopy Time|Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone.|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest||||Minutes||Full Range|Median
1334509|NCT02021071|Primary|System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness|"Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures.~The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability.~The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average"|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest|SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning)|||Scores on a scale||Standard Deviation|Mean
1334510|NCT02020941|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Up to 30 days after completion of study treatment, up to 2 years|All patients enrolled and received treatment.|||participants|||Number
1334511|NCT02020941|Secondary|Duration of Response (DOR)|Analysis will be performed using Kaplan-Meier estimates. Time from date of first confirmed response of partial response or better to date of progression or death. Only patients who had a response of partial response or better will be included in this analysis.|Time from first evidence of PR or better to disease progression or death, assessed up to 2 years|All patients who had a response of partial response or better|||months||95% Confidence Interval|Median
1334512|NCT02020941|Secondary|Time to Progression (TTP)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression. The observations of patients who died or remained alive and progression free were censored at date of death or last disease evaluation, respectively.|Time from first dose to disease progression, assessed up to 2 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
1334513|NCT02020941|Secondary|Progression-free Survival (PFS)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at date of last disease evaluation.|Time from first dose to first observed disease progression or death, assessed up to 2 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
1334514|NCT02020941|Secondary|Overall Response Rate (ORR) After 4 Courses of Treatment|Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 16 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
1334515|NCT02020941|Primary|Overall Response Rate (ORR) After 8 Courses of Treatment|: Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 32 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
1334516|NCT02020889|Secondary|Maximum Change From Baseline in QTcF and QTcB Values|Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.|Baseline and up to Week 60|Safety Population|||msec||Standard Deviation|Mean
1334517|NCT02020889|Secondary|Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values|Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 60|Safety Population|||milliseconds (msec)||Standard Deviation|Mean
1334518|NCT02020889|Secondary|Change From Baseline in Body Temperature|Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||Degree celsius||Standard Deviation|Mean
1334519|NCT02020889|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||beats per minute (bpm)||Standard Deviation|Mean
1334553|NCT02020616|Secondary|Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||Percentage of Participants|||Number
1334520|NCT02020889|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels|SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline up to Week 60|Safety Population|||millimeter of mercury (mm of Hg)||Standard Deviation|Mean
1334521|NCT02020889|Secondary|Number of Participants With Anti-Mepolizumab Antibodies|Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.|Up to Week 60|Safety Population|||Participants|||Number
1334522|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Erythrocytes Levels|Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||10^12 cells/L||Standard Deviation|Mean
1334523|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels|Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||Picogram (pg)||Standard Deviation|Mean
1334524|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels|Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||femtoliter (fL)||Standard Deviation|Mean
1334525|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels|Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||g/L||Standard Deviation|Mean
1334526|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels|Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||10^9 cells/L||Standard Deviation|Mean
1334527|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameter of Troponin Levels|Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||µg/L||Standard Deviation|Mean
1334528|NCT02020889|Secondary|Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol Levels|Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. NA indicates that data were not available.|Baseline and up to Week 60|Safety Population|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1334529|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels|Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||micromole per liter (µmol/L)||Standard Deviation|Mean
1334566|NCT02020369|Secondary|Number of Administrations of Study Drug Per Mild/Moderate Bleeding Episode||Within 24 hours of Bleeding Episode|Treated Population with non-missing measurements|||Number of Administrations of Study Drug|Bleeding episodes|Standard Deviation|Mean
1334530|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels|Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||gram per liter (g/L)||Standard Deviation|Mean
1334531|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels|Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety population|||International Unit per Liter (IU/L)||Standard Deviation|Mean
1334532|NCT02020889|Secondary|Number of Participants With Local and Systemic Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.|Up to Week 52|Safety Population|||Participants|||Number
1334533|NCT02020889|Secondary|Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period|The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Up to Week 52|ITT Population|||Participants|||Number
1334534|NCT02020889|Secondary|Number of Participants Who Are in Remission at 36 and 48 Weeks|The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Week 36 and Week 48|ITT Population|||Participants|||Number
1334535|NCT02020889|Secondary|Number of Participants in Each Category of Accrued Duration of Remission|Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Up to Week 52|ITT Population|||Participants|||Count of Participants
1334536|NCT02020889|Secondary|Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period|The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Up to Week 52|ITT Population|||Participants|||Number
1334537|NCT02020889|Secondary|Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.|The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, >0 to <=4.0mg, >4.0 to <=7.5mg and >7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.|Week 48 and Week52|ITT Population|||Participants|||Count of Participants
1334538|NCT02020889|Secondary|Time to First EGPA Relapse|EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to >4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.|Up to Week 52|ITT Population|||Participants|||Number
1334539|NCT02020889|Primary|Number of Participants Who Are in Remission at 36 and 48 Weeks|The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Week 36 and Week 48|ITT Population|||Participants|||Number
1334540|NCT02020889|Primary|Number of Participants in Each Category of Accrued Duration of Remission|Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.|Up to Week 52|ITT Population|||Participants|||Count of Participants
1334541|NCT02020863|Primary|Fluid Status During Surgery|The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.|Duration of Surgery, up to 8 hours|Closed Loop Study population at Stroke Volume Variation (SVV) ≤12%|||percentage of case time||Standard Deviation|Mean
1334542|NCT02020837|Primary|Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery|Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.|3 and 6 months from surgery|Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.||||||
1334543|NCT02020616|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102|AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours.|Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetics|||microgram•hour/milliliter (µg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
1334544|NCT02020616|Secondary|Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint|LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug.|||milligram/square centimeter (mg/cm2)||Standard Error|Least Squares Mean
1334545|NCT02020616|Secondary|Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])|LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug.|||nanogram/milliliter (ng/mL)||Standard Error|Least Squares Mean
1334546|NCT02020616|Secondary|Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])|LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug.|||microgram/liter (ug/L)||Standard Error|Least Squares Mean
1334547|NCT02020616|Secondary|Percentage of Participants With Hypoglycemia|Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia.|Baseline through Week 12|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1334548|NCT02020616|Secondary|Percentage of Participants With Anti-Drug Antibodies to LY3053102|Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value.|Baseline through Study Completion (Up to 6 Months)|All randomized participants who received at least 1 dose of study drug and had evaluable immunogenicity.|||Percentage of Participants|||Number
1334549|NCT02020616|Secondary|Change From Baseline in Lipids at 12-Week Endpoint|Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||mg/dL||Standard Error|Least Squares Mean
1334550|NCT02020616|Secondary|Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint|7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
1334551|NCT02020616|Secondary|Change From Baseline in Body Weight at 12-Week Endpoint|LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||kilogram (kg)||Standard Error|Least Squares Mean
1334552|NCT02020616|Secondary|Percentage of Participants That Require Rescue Therapy|Percentage of participants that required >=1 rescue (blood glucose lowering) medications.|Baseline through Week 12|All randomized participants who took at least 1 dose of study drug, and who had a baseline and a post-baseline measurement for the time point.|||Percentage of Participants|||Number
1334554|NCT02020616|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||Percent of HbA1c||Standard Error|Least Squares Mean
1334555|NCT02020577|Secondary|Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Afatinib)|MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.|All treatment cycle (each treatment cycle of 21 days)|Treated Set|||mg|||Number
1334556|NCT02020577|Secondary|Disease Control Rate|"For patients with measurable disease, disease control was defined as the proportion of patients having at least a best overall response of CR, PR or stable disease (SD).~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set|||Percentage of participants|||Number
1334557|NCT02020577|Secondary|Objective Response|"Objective response was defined as the proportion of patients with measurable disease having at least a best overall response of complete response (CR) or partial response (PR), according to RECIST version 1.1.~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set|||Percentage of participants|||Number
1334558|NCT02020577|Secondary|Best Overall Response|"Best overall response (according to RECIST version 1.1) was defined as the best response recorded at any time from the first administration of afatinib or cetuximab to the End of Treatment (EOT).~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set|||Percentage of participants|||Number
1334559|NCT02020577|Secondary|Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Cetuximab)|MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.|All treatment cycle (each treatment cycle of 21 days)|Treated Set|||mg/m2|||Number
1334560|NCT02020577|Secondary|Dose Limiting Toxicities During All Treatment Cycles|Number of patients with DLT occuring during all treatment cycle is presented|All treatment cycle (each treatment cycle of 21 days)|Treated Set|||Participants|||Number
1334561|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Cetuximab).|Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with DLTs during the first treatment cycle (Dose escalation part).|First treatment cycle|Dose finding cohort treated set|||mg/m2|||Number
1334562|NCT02020577|Primary|Dose Limiting Toxicities During Cycle 1|"Number of Patients With Dose Limiting Toxicity (DLT) Occurring during Cycle 1. The following drug related AEs qualified as DLT:~1) CTCAE Grade ≥2 decrease in cardiac left ventricular function 2) CTCAE Grade 2 diarrhoea lasting for ≥7 days, despite appropriate use of standard antidiarrheal therapy based on Protocol Amendment 1 dated 22 Oct 2013 3) CTCAE Grade ≥3 diarrhoea despite appropriate use of standard anti-diarrheal therapy for at least 2 days. 4) CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days 5) CTCAE Grade ≥3 rash despite standard medical management. 6) CTCAE Grade ≥3 fatigue lasting more than 7 days. 7) All other AEs of CTCAE Grade ≥3 (except alopecia and allergic reaction) that led to an interruption of afatinib and/or cetuximab dosing for more than 14 days until recovery to baseline or Grade 1, whichever was higher. 8) CTCAE Grade 4 hypomagnesemia or Grade 3 hypomagnesemia with clinically-significant sequelae"|First 21-day treatment cycle|Dose finding cohort treated set.|||Participants|||Number
1334563|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).|Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with dose limiting toxicity (DLT) during the first treatment cycle (Dose escalation part). The MTD is defined as the highest dose level at which less than 33% of the patients experience DLT in first treatment cycle.|First 21 days treatment cycle|Dose finding cohort treated set: This patient set includes all patients enrolled in part A of the trial who were documented to have taken at least one dose of study medication.|||mg|||Number
1334564|NCT02020512|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 5|Intent-to-Treat: all treated patients|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1334565|NCT02020369|Secondary|Total Amount of Study Drug Administered Per Mild/Moderate Bleeding Episode||Through study completion|Treated Population with non-missing measurements|||µg/kg per bleeding episode|Bleeding Episodes|Standard Deviation|Mean
1334567|NCT02020369|Secondary|Time to Assessment of a “Good” or “Excellent” Response of Mild/Moderate Bleeding Episodes by the Patient|"Categories of Response to Treatment are Described as Follows:~None: No noticeable effect of the treatment on the bleed or worsening of patient’s condition. Continuation of treatment with the study drug was needed.~Moderate: Some effect of the treatment on the bleed was noticed, e.g., pain decreased or bleeding signs improved, but bleed continued and required continued treatment with the study drug. Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely been reduced by the treatment, but had not completely disappeared. Symptoms had improved enough to not require more infusions of the study drug.~Excellent: Full relief of pain and cessation of objective signs of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage). No additional infusion of study drug was required."|Within 24 hours of Bleeding Episode|Treated Population with non-missing measurements|||Hours|Bleeding Episodes with event|95% Confidence Interval|Median
1334568|NCT02020369|Secondary|Proportion of Mild/Moderate Bleeding Episodes With Patient (Pt)-Reported “Good” or “Excellent” Responses at 12 Hours|"Based on Patient-Reported Good or Excellent responses as per the below descriptions:~Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely been reduced by the treatment, but had not completely disappeared. Symptoms had improved enough to not require more infusions of the study drug.~Excellent: Full relief of pain and cessation of objective signs of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage). No additional infusion of study drug was required."|at 12 hours|Treated Population|||Pt-reported proportion success of BEs|Bleeding Episodes (BEs)|95% Confidence Interval|Number
1334569|NCT02020369|Primary|Proportion of Successfully Treated Mild/Moderate Bleeding Episodes|"For the primary efficacy endpoint, successful treatment of a bleeding episode was defined as a combination of the following:~“Good” or “Excellent” response noted by the patient~Study drug treatment: No further treatment with study drug beyond timepoint for this bleeding episode~No other hemostatic treatment needed for this bleeding episode~No administration of blood products that would indicate continuation of bleeding beyond timepoint~No increase of pain beyond timepoint that could not otherwise be explained"|12 hours after first administration of study drug|Treated Population|||Proportion of Success of BEs|Bleeding Episodes (BEs)|95% Confidence Interval|Number
1334570|NCT02020304|Secondary|Pruritus|patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined)|30 minutes||||units on a scale||Standard Deviation|Mean
1334571|NCT02020304|Secondary|Analgesia Onset-15 Minutes Post Injection||up to 3 hours|number of subjects who achieved a VAS pain score of </= 3 at 15 minutes after injection|||Participants|||Count of Participants
1334572|NCT02020304|Secondary|Analgesia Onset-10 Minutes Post Injection||up to 3 hours|number of subjects who achieved a VAS pain score of </= 3 at 10 minutes after CSE injection|||Participants|||Count of Participants
1334573|NCT02020304|Secondary|Analgesia Onset-5 Minutes Post Injection||from time of CSE administration|number of subjects who achieved a VAS pain score of </=3 at 5 minutes after CSE injection|||Participants|||Count of Participants
1334574|NCT02020304|Primary|Time|length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.|up to 3 hours||||minutes||Standard Deviation|Mean
1334575|NCT02020135|Primary|Overall Radiologic Response|Overall radiologic response was measured at baseline and post-baseline. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.|25 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). All subjects (n=9) enrolled in 2301EXT were evaluated.|||% of subjects|||Number
1334576|NCT02020135|Primary|CTC Response|Circulating tumor cells (CTC) response was measured at baseline and had at least one post-baseline assessment. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 50%.|25 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.|||% of responders|||Number
1334577|NCT02020135|Primary|Percentage of Participants With Total Serum PSA Response|Total serum PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.|25 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.|||% of responders|||Number
1334578|NCT02020031|Primary|Mean Concentration of Vancomycin in Bone Samples|During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|baseline to 24 hours||||µg/g||Standard Deviation|Mean
1334649|NCT02018653|Primary|Time to Resolution of Diarrhea (TTRD)|The primary endpoint is time to resolution of diarrhea (TTRD) defined as the time of the bowel movement that is not followed by another bowel movement within 8 hours. Participants will be evaluated for the primary endpoint for up to 6 days.|6 days|Too few subjects enrolled to make any conclusions.|||hours|||Number
1334579|NCT02020031|Primary|Mean Concentration of Vancomycin in Subcutaneous Fat|During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|Baseline to 24 hours||||µg/g||Standard Deviation|Mean
1334580|NCT02019979|Secondary|Number of Participants With LKBI Mutation|To evaluate LKBI mutations as a potential bio-marker to predict subjects who will benefit most from metformin in combination with a carbohydrate restricted diet|6 months||||Participants|||Count of Participants
1334581|NCT02019979|Secondary|Overall Survival|Overall survival (OS) is defined as time from date of first dose to date of death from any cause.|up to 30 months||||months||Full Range|Mean
1334582|NCT02019979|Primary|Progress Free Survival|Progress Free Survival (PFS) is defined as the time from the date of the first dose of treatment to the earlier of the dates of first disease progression per RECIST 1.1 or death from any cause.|Time after day 1 cycle 1 to first disease progression for up to 20 months||||months||Full Range|Median
1334583|NCT02019719|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4|Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant while in a supine position. ECGs were performed consistently either before or after dialysis throughout the study. ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto W4 have been presented.|Upto Week 4|Safety population.|||Participants|||Count of Participants
1334584|NCT02019719|Secondary|Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4|Vital sign HR was recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for HR was < 40 or > 110 beats per minute. Participant's with values higher than the PCI range have been presented.|Upto Week 4|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1334585|NCT02019719|Secondary|Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4|Vital signs SBP and DBP were recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for SBP was < 85 or > 170 and for DBP was < 45 or > 100 millimeters of mercury. Participant's with values high and low from the PCI range have been presented.|Upto Week 4|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1334586|NCT02019719|Secondary|Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4|The PCI range was as follows: alkaline phosphates >= 3 times upper limit of normal range [ULRR]), potassium (>0.5 millimoles/liter below the LLRR or >1.0 millimoles/liter above the ULRR), phosphate (>0.323 millimoles/liter above ULRR or below lower limit reference range [LLRR]), glucose (<3.9 or >22 millimoles/liter), magnesium (<LLRR or > 0.3 milimoles/liter above ULRR), lymphocytes <0.5x LLRR, neutrophils (<0.5 times LLRR), platelets (80 or >500 times giga/liter), platelets (80 or >500 times giga/liter) and leukocytes >1 x giga/liter below the LLRR or >5 x GI/L above the ULRR. The participants who had PCI values higher and lower than the reference range have been presented.|Upto Week 4|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1334587|NCT02019719|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy|An AE is defined as any untoward medical occurrence in clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any AE which results in death; is life-threatening; requires participant hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.|Upto Week 4|Safety population.|||Participants|||Count of Participants
1334588|NCT02019719|Secondary|Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4|Blood samples for plasma pharmacokinetic analysis were collected at Week 4 (pre-dose, 1, 2, 3 hours post-dose). Individual plasma GSK1278863 and M-GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, GSK2531403 concentrations have been presented.|Week 4|Pharmacokinetic Population: All participants from whom a Pharmacokinetic sample was obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||micrograms/liter||Standard Deviation|Mean
1334589|NCT02019719|Secondary|Percent CFB in Transferrin Saturation (TS) at Week 4|TS was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1.|Baseline (Day 1) and Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
1334590|NCT02019719|Secondary|CFB in Transferrin at Week 4|Transferrin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.|Baseline (Day 1) and Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||grams/liter||Standard Deviation|Mean
1334591|NCT02019719|Secondary|CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4|TIBC, UIBC and Iron were used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.|Baseline (Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||micromoles/liter||Standard Deviation|Mean
1334592|NCT02019719|Secondary|CFB in Ferritin at Week 4|Ferritin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post dose value at Week 4.|Baseline (Day 1) and Week 4|ITT population. Only those participants with data available at the specified time points were analyzed.|||micrograms/liter||Standard Deviation|Mean
1334650|NCT02018562|Secondary|Intensive Care Unit (ICU) Length of Stay|Measured in days|Time of discharge from the ICU (Approximately 6-8 months)||||days||Standard Deviation|Mean
1334593|NCT02019719|Secondary|Percent CFB in Hepcidine Upto Week 4|Blood samples for hepcidine were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose) and Week 4 (pre-dose). Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1.|Baseline (Day 1) Upto Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
1334594|NCT02019719|Secondary|Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4|Blood samples for VEGF were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed percent CFB was calculated as 100 multiplied by the maximum observed exponential mean change on a log scale minus 1.|Baseline (Day 1) Upto Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
1334595|NCT02019719|Secondary|Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4|Blood samples for EPO were collected on Day 1 (pre-dose), Week 2 (collected approx 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed CFB was calculated by subtracting the Baseline value from the maximum observed value between Week 1 and Week 4.|Baseline (Day 1) Upto Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||International units/liter||Standard Deviation|Mean
1334596|NCT02019719|Secondary|Number of Participants Who Reached Pre-defined Hgb Stopping Criteria|Hgb stopping criteria was defined as: (1) Hgb <7.5 g/dL (2) 7.5 <= Hgb <1 3.0 g/dL and >2 g/dL Hgb change over 2W (3) Hgb >=13.0 g/dL. The number of participants who reached pre-defined Hgb stopping criteria have been presented.|Upto Week 4|ITT population.|||Participants|||Count of Participants
1334597|NCT02019719|Secondary|Percentage of Participants Who Achieved Hgb Response at Week 4|Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The percentage of participants with Hgb response: Hgb increase <-1.0, Hgb increase -1.0 -< -0.5, Hgb increase -0.5 -< 0.5, Hgb increase 0.5 -< 1.0 and Hgb increase >=1.0 have been presented.|Week 4|ITT population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Percentage of participants|||Number
1334598|NCT02019719|Secondary|Number of Participants Who Achieved Hgb Response at Week 4|Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The number of participants with Hgb response: Hgb increase <-1.0, Hgb increase -1.0 -< -0.5, Hgb increase -0.5 -< 0.5, Hgb increase 0.5 -< 1.0 and Hgb increase >=1.0 have been presented.|Week 4|ITT population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1334599|NCT02019719|Secondary|CFB in Hgb Upto Week 8|Hgb assessments were performed at Baseline, Week 1, Week 2, Week 3, W eek4/Early withdrawal and Week 8 (follow-up) based on central laboratory (Quest diagnosis). Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.|Baseline (Day 1) Upto Week 8|ITT population. Only those participants available at the specified time points were analyzed.|||g/dL||Standard Deviation|Mean
1334600|NCT02019719|Primary|Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4|Baseline was defined as the value on Day 1. CFB was calculated by subtracting the baseline value from the post-dose value at Week 4. To model the dose-response relationship a four-parameter Emax model was used. E0 is the expected Hgb change from Baseline for a participant receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a participant receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Minimal Effective Dose (MED) is defined as the smallest dose that achieves a placebo-corrected change of 0.5 g/dL over Week 4. Target dose (TD) is defined as the dose that achieves a placebo-corrected 1.0 g/dL change over Week 4. Maximum Acceptable Dose (MAD) is defined as the dose that achieves a placebo-corrected 2.0 g/dL change over Week 4.|Baseline (Day 1) and Week 4|Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on treatment assessment. Only those participants with data available at the indicated time points were analyzed.|||grams/deciliter (g/dL)||Standard Error|Least Squares Mean
1334601|NCT02019563|Secondary|MTA/FS Pulpotomy and RCT Treated Incisor Survival|Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups. One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations. The log-rank test was used to statistically compare survival of incisors.|12 and 18 months|Four participants in the MTA/FS and two participants in the RCT group did not have data collected due to lost to follow-up. Remaining participants were censored if lost to follow-up, exfoliated, lost to trauma or had a non-occurrence of a failure before the trial end.|||Proportion of participants|||Number
1334602|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.|18 months after the procedure||||Proportion of incisors|Participants||Number
1334603|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes. Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher’s Exact test.|12 months after the procedure||||Proportion of incisors|Participants||Number
1334651|NCT02018562|Secondary|Overall Hospital Length of Stay|Measured in days|Time of discharge from the hospital (Approximately 6-8 months)||||days||Standard Deviation|Mean
1335902|NCT01998360|Secondary|Blood Loss|Number of ml of blood lost during the procedure, as assessed by the surgeon|During procedure (up to 1 hour)||||ml||Inter-Quartile Range|Median
1334604|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|18 months after the procedure||||Proportion of incisors|Participants||Number
1334605|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|12 months after the procedure||||Proportion of incisors|Participants||Number
1334606|NCT02019550|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8|The MusiQoL is a validated 31-item questionnaire describing 9 dimensions named according to its constitutive items:activities of daily living (8 items);psychological well-being (4 items);symptoms (3 items);friends relationships (4 items);family relationships (3 items);satisfaction with health care (RHCS 3 items);sentimental and sexual life (2 items);coping (2 items);and rejection (2 items). Each of the questions was answered using a 6-point Likert scale, defined as 1–Never/Not at all, 2–Rarely/A little, 3–Sometimes/Somewhat, 4–Often/A lot, 5–Always/Very much and 6–Not applicable. The scores of each dimension were obtained by computing mean of the item scores of dimension with negatively worded item scores reversed so that higher scores indicated higher health-related QoL. All 9 dimension scores were linearly transformed to a 0–100 scale,where higher score=higher health-related QoL. Global index score was computed as mean of the 9 dimension scores (range 0-100;higher score=higher QoL).|Baseline, up to Week 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed = subjects evaluable for this outcome, “Number Analyzed” = subjects evaluable for specified dimensions."|||score on a scale||Standard Deviation|Mean
1334607|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as very difficult”, “difficult” or “neither easy nor difficult” were reported. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334608|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall satisfaction with using the device. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree” that they were satisfied with the device. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334609|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked they would recommend injection device to others needing REBIF therapy. Subjects responded as “Very unlikely”, “Unlikely”, “Neutral/no opinion”, “Likely”, “Very likely”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334610|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the trainer provided easily understandable, unbiased and practical information about proper injection. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334611|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of anxiety while giving themselves an injection with device. Subjects assessed their anxiety as “Not at all anxious”, “A little anxious”, “Moderately anxious”, “Very anxious”, “Extremely anxious”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334652|NCT02018562|Secondary|Patient Satisfaction With a Talking Tracheostomy Tube|Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction.|2 weeks|This outcome was assessed for all 22 participants who completed the intervention arm. No data was collected for any of the participants in control arm.|||Participants|||Count of Participants
1334612|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the device features help minimize safety hazards. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334613|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess how convenient it was to store the injection device. Subjects responded as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree” that the device was convenient to store.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome. Here results are presented by device sequence."|||percentage of subjects|||Number
1334614|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of convenience of using the device as “Extremely inconvenient”, “Somewhat inconvenient”, “Neutral/no opinion”, “Somewhat convenient”, or “Extremely convenient”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334615|NCT02019550|Secondary|Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while away from home. Subjects assessed if they were satisfied with their ability to use the device while away from home as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed = subjects evaluable for this outcome, Number Analyzed=subjects evaluable at the specified time point."|||subjects|||Number
1334616|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with holding the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334617|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to number of steps it took to complete an injection with the device. Subjects assessed if they were satisfied as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334618|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to the amount of time it took to complete injection with the device. Subjects assessed if they were satisfied as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
1334619|NCT02019550|Secondary|Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while traveling (defined as being away from home overnight). Subjects assessed if they were satisfied with their ability to use the device while traveling overnight as “Strongly disagree”, “Disagree”, “Neither agree nor disagree”, “Agree”, “Strongly agree”. Here results are presented by device sequence.|Weeks 4 and 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” = subjects evaluable for this outcome, “Number Analyzed”=subjects evaluable at the specified time point.|||subjects|||Number
1334653|NCT02018562|Secondary|Level of Independence With Talking Tracheostomy Tube|Participants were asked how independently they thought they could use the tracheostomy tube. Will report the number of participants who indicated some level of independence.|2 weeks|This outcome was assessed for all 22 participants who completed the intervention arm. No data was collected for any of the participants in control arm.|||Participants|||Count of Participants
1334620|NCT02019550|Primary|Percentage of Subjects Rating Each Device as “Easy/Very Easy to Use” Based on User Trial Questionnaire (UTQ) up to Week 8|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as “easy” or “very easy” were reported. Here results are presented by device used.|Baseline up to Week 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.|||percentage of subjects|||Number
1334621|NCT02019550|Primary|Percentage of Subjects Rating Each Device as “Easy/Very Easy to Use” Based on User Trial Questionnaire (UTQ) at Week 8|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as “easy” or “very easy” were reported. Here results are presented by device sequence.|Week 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.|||percentage of subjects|||Number
1334622|NCT02019550|Primary|Percentage of Subjects Rating Each Device as “Easy/Very Easy to Use” Based on User Trial Questionnaire (UTQ) at Week 4|The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as “very difficult”, “difficult”, “neither easy nor difficult”, “easy”, or “very easy”. Percentage of subjects who rated the overall use of device as “easy” or “very easy” were reported. Here results are presented by device sequence.|Week 4|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.|||percentage of subjects|||Number
1334623|NCT02019472|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24|The ACR 20 Response is defined as >= 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement in 3 of following 5 assessments: subject’s assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), subject’s global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, subject’s assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum CRP.|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.|||Percentage of participants|||Number
1334624|NCT02019472|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24|"The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient’s Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of 0-10, with the minimum score= 0 (best) to maximum score= 10 (worst). The DAS28 (ESR) remission is defined as a DAS28 (ESR) value of less than 2.6 at a visit."|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.|||Percentage of participants|||Number
1334625|NCT02019472|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|The ACR 50 Response is defined as greater than or equal to (>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >= 50% improvement in 3 of following 5 assessments: subject’s assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), subject’s global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant’s assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.|||Percentage of participants|||Number
1334626|NCT02019472|Primary|Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24|"The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient’s Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of 0-10, with the minimum score= 0 (best) to maximum score= 10 (worst)."|Baseline and Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent. Participants with missing DAS28 (ESR) at baseline were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1334627|NCT02019277|Primary|Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Below 50%|LVEF was assessed using echocardiography (ECHO) or multiple-gated acquisition (MUGA) scans. Percentage of participants with LVEF below 50% at any time during the study was reported.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants|||Number
1335903|NCT01998360|Secondary|Number of Participants With Adverse Events|Bleeding, hematoma, infection and other rare adverse events|1 month||||participants|||Number
1334628|NCT02019277|Primary|Percentage of Participants With AEs of Suspected Cardiac Origin, by New York Heart Association Classification (NYHA)|NYHA functional classification includes: Class I (no limitation in physical activity; ordinary physical activity does not cause fatigue, breathlessness or palpitation), Class II (slight limitation of physical activity; ordinary physical activity results in fatigue, palpitation, breathlessness or angina pectoris), Class III (marked limitation of physical activity; less than ordinary activity will lead to symptomatically 'moderate' heart failure) and Class IV (inability to carry out any physical activity without discomfort; symptoms of congestive cardiac failure are present even at rest). Percentage of participants with AEs suspected to be of cardiac origin by maximum NYHA classification was reported.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants|||Number
1334629|NCT02019277|Primary|Percentage of Participants With AEs Leading to Premature Discontinuation of Investigational Medicinal Products (IMPs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs leading to premature discontinuation of IMPs (pertuzumab and trastuzumab) was reported. AEs included both SAEs and non-SAEs. The 95% CI was computed using Clopper-Pearson method.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants||95% Confidence Interval|Number
1334630|NCT02019277|Primary|Percentage of Participants With AEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Intensity Grades|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of AEs were graded according to NCI CTCAE version 4.0 on a 5-point scale: Grade 1=Mild, intervention not indicated; Grade 2=Moderate, local or noninvasive intervention indicated; Grade 3=Severe or medically significant but not immediately life-threatening; Grade 4= Life-threatening consequences, urgent intervention indicated; and Grade 5=Death related to AE. Percentage of participants with AEs by maximum severity grades was reported.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants|||Number
1334631|NCT02019277|Secondary|Number of Participants Receiving Second-Line Treatment by Treatment Type|Second-line anti-cancer treatment was initiated after disease progression on first-line therapy. Number of participants who started second-line of treatment by treatment type was reported. Participants who received combination treatment were counted for each treatment type.|Baseline up to approximately 35 months|Analysis was performed on the ITT population participants who started second-line of treatment.|||participants|||Number
1334632|NCT02019277|Secondary|OS During Second-Line of Treatment|The OS during second-line therapy was defined as the time from the start of second-line therapy (failure of first-line therapy) until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS during second-line therapy was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months)|Analysis was performed on the ITT population participants who started second-line of treatment.|||months||95% Confidence Interval|Median
1334633|NCT02019277|Secondary|Percentage of Participants Who Died During Receiving Second-Line of Treatment|Percentage of participants who died from any cause during second-line of treatment was reported.|From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months)|Analysis was performed on the ITT population participants who started second-line of treatment.|||percentage of participants|||Number
1334634|NCT02019277|Secondary|Event-free Survival (EFS) Assessed According to RECIST Version 1.1|EFS was defined as the time from the start of treatment until the first documented initiation of non-protocol-specified treatment for metastatic breast cancer, PD, or death from any cause, whichever occurred first. Participants without treatment change, PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment after baseline were censored at baseline unless death occurred before first scheduled tumor assessment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median EFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
1334635|NCT02019277|Secondary|Overall Survival (OS)|The OS was defined as the time from the start of treatment until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
1334636|NCT02019277|Secondary|Percentage of Participants Who Died Due to Any Cause|Percentage of participants who died due to any cause during the study was reported.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||percentage of participants|||Number
1334647|NCT02018809|Secondary|Morisky Medication Adherence Scale (MMAS)|"The secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: “Yes” = 0 and “No” = 1 (and 0 = 0 and 1-4 = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: 0 = High Adherence; 1-2 = Medium Adherence; 3-8 = Low Adherence."|90 days||||units on a scale||Inter-Quartile Range|Median
1334637|NCT02019277|Secondary|Progression-free Survival (PFS) Assessed According to RECIST Version 1.1|PFS was defined as the time from start of treatment until first documented PD or death from any cause, whichever occurred first. Participants without PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment data after the baseline were censored at baseline unless death occurred before first scheduled tumor assessment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
1334638|NCT02019277|Secondary|Percentage of Participants With PD (Assessed According to RECIST Version 1.1) or Death Due to Any Cause|For TLs, PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD, taking as reference the smallest SD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||percentage of participants|||Number
1334639|NCT02019277|Secondary|Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|BOR was defined as a confirmed CR or PR. All measurable lesions up to a maximum of 2 lesions per organ and 5 in total were identified as target lesions (TLs) and recorded at baseline. A sum of the diameters (longest for non-nodal lesions, short axis [SA] for nodal lesions) for all TLs was calculated as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs and were recorded at baseline. CR was defined as the disappearance of all TLs and SA reduction to less than (<) 10 millimeter (mm) for nodal TLs/ non-TLs. PR was defined as greater than or equal to (>/=) 30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. The 95% CI was computed using Clopper-Pearson method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on ITT population. Only participants with measurable disease at baseline were included in the analysis. Participants without a post-baseline tumor assessment were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
1334640|NCT02019277|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs and SAEs was reported. AEs included both SAEs and non-SAEs. The 95% confidence interval (CI) was computed using Clopper-Pearson method.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population, which included all enrolled participants who received at least one dose of pertuzumab IV or trastuzumab SC.|||percentage of participants||95% Confidence Interval|Number
1334641|NCT02018822|Primary|Percent of Teeth With Polish-ability of A, B1 or B2|A= Smooth & highly shiny, similar to enamel B1= Smooth & satin, highly reflective B2= Smooth & shiny but not highly reflective|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
1334642|NCT02018822|Primary|Percent of Teeth With Proximal Contact|A= Tight proximal contacts evaluated with dental floss. B= Proximal contacts are weak but present. C= No proximal contacts but not visibly open. NA= Class I restorations|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
1334643|NCT02018822|Primary|Percent of Teeth With Marginal Discoloration of A or B|"A= There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure.~B= There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction."|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
1334644|NCT02018822|Primary|Percent of Teeth With Marginal Integrity Graded A, B1 and B2|A= No visible evidence of a crevice along the margin into which the explorer will penetrate B1= Explorer clicks on the margin B2= Visible evidence of a crevice|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
1334645|NCT02018822|Primary|Percent of Teeth Scored as A or B for Color Match|"A=The restoration appears to match the shade and translucency of adjacent tooth structure.~B=The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency."|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
1334646|NCT02018822|Primary|Percent of Teeth With Anatomic Form Graded as A or B.|"Anatomic form was graded as:~A=The restoration is continuous with existing form. B=The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine."|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
1334648|NCT02018809|Primary|Statin Adherence|The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.|90 days||||percentage of correct statin doses||Standard Deviation|Mean
1334654|NCT02018562|Secondary|Speech Intelligibility|The Speech Intelligibility Test has 11 randomly computer generated sentences that patients are asked to read aloud. They are recorded and judged by an unfamiliar listener at a later time. Scores range from 0 - 100 with higher scores indicating greater level of speech intelligibility.|2 weeks|Only 18 participants in the intervention group were assessed because only 18 of them were able to read the sentences. No data was collected from any participants in the control group for this outcome measure.|||percentage of intelligible sentences||Standard Deviation|Mean
1334655|NCT02018562|Primary|Change in Quality of Life|Voice-Related Quality of Life (V-RQOL). It is a 10-item scale with each items 2 - 10 and total score ranges from 20 - 100. Lower scores refers to higher quality of life and Higher scores refer to lower level quality of life.|Baseline; 2 weeks post BLUSA|Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.|||units on a scale||Standard Deviation|Mean
1334656|NCT02018562|Primary|Change in Quality of Life|Quality of Life in Mechanically Ventilated Patients Questionnaire (QOL-MV) was used to measure quality of life. It is a 12-item scale with each items 0 - 10 and total score ranges from 0 - 120. Lower scores refers to lower quality of life and Higher scores refer to higher level quality of life. To be assessed at baseline and 2 weeks post Portex Blueline Ultra Suctionaid (BLUSA).|Baseline; 2 weeks post BLUSA|Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.|||units on a scale||Standard Deviation|Mean
1334657|NCT02017574|Secondary|EEG Derived High Alpha Power|Brain electrophysiology measure of attentional processes as indexed by high alpha power (10-13 Hz). The unit of measurement is a percentage as the amount of power (microvolts squared) in the high alpha band was divided by the total power in the spectrum (i.e. 1-50 Hz). This method is commonly employed to normalize the power of a particular frequency if the statistical design includes a between subjects factor.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.|||percentage of the total power||Standard Error|Mean
1334658|NCT02017574|Primary|Quality of Motor Performance|Quality of motor behavior was indexed by the percentage of samples in which the participants were within the trained (i.e. optimal) trajectory. The trained trajectory was a 2cm wide channel in the shape of a half circle between two targets which were 25cm apart from each other. Therefore, the scale measure is a percentage which can range between 0 and 100%.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.|||percentage of samples not 'on' task||Standard Deviation|Mean
1334659|NCT02017522|Secondary|The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis|"As a secondary outcome of this study we will evaluate the ratio of 11C-PBR28 PET activity in regions with fibrosis indicated by decreased myocardial perfusion on 82Rb PET and/or late gadolinium enhancement on cardiac MRI without imaging signs of active inflammation compared to 11C-PBR28 PET activity in myocardial segments which appear normal on 82Rb PET, FDG PET and cardiac MRI. This outcome will thus be expressed by 11C-PBR28 PET uptake in fibrotic regions as a percentage of uptake in normal segments~We will also evaluate the concordance between extracardiac activity seen in 11C-PBR28 and FDG PET, and when available, histopathology of contemporaneous biopsy specimens."|1 hour scan|Because the two scans performed provided inadequate clarity to allow any analysis, the additional measurements anticipated as secondary were not feasible.||||||
1334660|NCT02017522|Primary|Ratio of 11C-PBR28 in the Myocardium|The primary outcome of this study will be the ratio of 11C-PBR28 PET activity in myocardial regions with inflammation indicated by FDG PET and/or edema indicated by increased T2 signal with cardiac MRI compared to the 11C-PBR28 PET activity in myocardial segments which appear normal on FDG PET and cardiac MRI. The primary outcome is thus the intensity of uptake in abnormal regions as a percentage of the intensity of uptake in normal segments.|1 hour scan|Insufficient myocardial tissue contrast to define abnormal and normal regions.||||||
1334661|NCT02017093|Primary|Fugl-Meyer Assessment Score|The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.|The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).||||units on a scale||Standard Deviation|Mean
1334662|NCT02017093|Primary|Improvement in Average Movement Trajectory Error From T1 to T2|While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.|The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).||||cm||Standard Deviation|Mean
1334663|NCT02017015|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time from the date of first treatment to the date of death. Participants who did not die at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cut-off date, whichever was earlier.|From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks|ITT population includes all enrolled participants|||months||95% Confidence Interval|Median
1334664|NCT02017015|Secondary|Duration of Response (DoR) Based on IRR According to RECIST Guidelines|DoR was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion is met to the date of disease progression based on IRR following RECIST 1.0. Only for those participants with a confirmed CR/PR. If a participant had disease progression, then the date of disease progression was the event date. For a participant who did not develop disease progression or disease progression occurred after 2 or more missing tumor assessments, the participant was censored on the date of last tumor assessment where the participant was documented to be progression free. If a participant died prior to disease progression, the participant was censored on the date of death. If patient started new anti-cancer therapy, the patient was censored on the last tumor assessment date on or prior to the start date of new anti-cancer therapy|Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks|Includes participants with a Confirmed Complete or Partial Response|||months||95% Confidence Interval|Median
1334665|NCT02017015|Primary|Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)|ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) based on independent radiological review per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Using RECIST Version 1.0, participants were to achieve either a complete response defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the independent radiological review of best overall response during study treatment.|Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks|Intent to Treat (ITT) population included all participants enrolled into the study|||percentage of participants||95% Confidence Interval|Number
1334666|NCT02017015|Secondary|Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as adverse events (AEs) that began or worsened in severity on or after the date of the first dose of study drug and within 30 days of the last dose of study drug. A Serious AE (SAE) = any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect; constitutes an important medical event. Treatment-related AEs (TRAEs) were any TEAEs considered to be related to the study drug. A TRAE is a TEAE with relationship as suspected to either ABI-007 or gemcitabine The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Other AEs not described in the CTCAE criteria, the intensity will be assessed by the investigator as mild grade (Gr 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Study drug initiation through 30 days after the last dose of study drug or End Of Study, whichever is later; maximum treatment duration was 54.9 weeks|Safety population includes all enrolled participants who received at least 1 dose of study drug|||participants|||Number
1334667|NCT02016963|Secondary|Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose|Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. Serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics|From the date of the dose administration of study agent for this study (Day 0) until Day 56|As-treated population|||Micrograms/milliliter (µg/mL)||Standard Deviation|Mean
1334668|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334669|NCT02016963|Secondary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334670|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334671|NCT02016963|Secondary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334871|NCT02014584|Secondary|Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period|The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).|Baseline and up to Week 24|Safety Population|||Participants|||Number
1334672|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334673|NCT02016963|Secondary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334674|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334675|NCT02016963|Secondary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334676|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334677|NCT02016963|Secondary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1334678|NCT02016963|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
1335904|NCT01998360|Primary|Intraoperative Duration|The number of minutes required to perform the surgical procedure|1 hour||||Min||Inter-Quartile Range|Median
1334679|NCT02016963|Primary|Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response|Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population : all participants who received 1 dose of study treatment.|||Participants|||Number
1334680|NCT02016898|Secondary|Change in Intraocular Pressure|To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation|post-operative day 1 to month 6|Five participants in each group were not included due to being lost to follow-up or deceased.|||mmHg (millimeters of mercury)||Standard Deviation|Mean
1334681|NCT02016898|Primary|Complication Rates|To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation|post-operative day 1 to month 6||||Participants|||Count of Participants
1334682|NCT02016690|Secondary|Mean Duration of Respiratory Support|The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||days||Standard Deviation|Mean
1334683|NCT02016690|Secondary|Number of Hospitalized Participants Requiring Respiratory Support|The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||Participants|||Count of Participants
1334684|NCT02016690|Secondary|Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection|The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||days||Standard Deviation|Mean
1334685|NCT02016690|Secondary|Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection|Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||Participants|||Count of Participants
1334686|NCT02016690|Secondary|Change in Lower Respiratory Tract Infection (LRI) Score During the Study|The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).|From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks|Participants with available data|||units on a scale||Standard Deviation|Mean
1334687|NCT02016690|Primary|Number of Participants With Adverse Drug Reactions|"An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: Related, Causality cannot be ruled out, or Not assessable as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: Death, Life-threatening condition, Hospitalization or prolonged hospitalization, Persistent or significant disability, or Other medically important condition. Information about AEs and ADRs was documented on the case report form (CRF)."|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.|||Participants|||Count of Participants
1334688|NCT02016690|Primary|Number of Participants With Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.|||Participants|||Count of Participants
1334689|NCT02016690|Primary|Number of Participants With Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.|||Participants|||Count of Participants
1334981|NCT02013830|Secondary|Overall Survival - Percentage of Participants Event Free at 12 Months|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.|||percentage of participants||95% Confidence Interval|Number
1334690|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334691|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first tac administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334692|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first tac administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334693|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Tac in Plasma)|"Cmax (maximum measured concentration of the tac in plasma).~PK sampling (relative to the first tac administration [h:min]):~Period 1:~for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334694|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the tac in plasma over the time interval from 0 to the last quantifiable point).~PK sampling (relative to the first tac administration [h:min]):~Period 1: for tac~0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h~Period 2 For tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334695|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the tac in plasma over the time interval from 0 extrapolated to infinity).~PK sampling (relative to the first tac administration):~Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h period 2 for tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|pharmacokinetic set of tac (PKS tac): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of tac in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334696|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334697|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334698|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by cyclo treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1335470|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population|||percentage of participants|||Number
1334699|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Cyclo in Plasma)|"Cmax (maximum measured concentration of the cyclo in plasma).~PK sampling (relative to the first cyclo administration [h:min]):~Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334700|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 to the last quantifiable point).~PK sampling (relative to the first cyclo administration [h:min]):~Period 1:~for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS cyclo|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334701|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity).~PK sampling (relative to the first cyclo administration [h:min])~Period 1:~for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h.~period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|pharmacokinetic set of cyclo (PKS cyclo): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of cyclo in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334702|NCT02016612|Secondary|Percent Breast Tissue Above Nipple|The percentage of breast tissue above and below the horizontal plane of the nipple over time|1 year post op||||percentage of volume||Full Range|Mean
1334703|NCT02016612|Primary|Nipple to Fold Measurement on Stretch|The Nipple to fold will be measured manually over time to 1 year|1 year post op||||centimeters||Full Range|Mean
1334704|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26|Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334705|NCT02016482|Secondary|Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study|The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.|up to Week 26|ITT Population in Period A: all participants who were randomized at Baseline and did not have PsA at Baseline. Observed cases.|||percentage of participants|||Number
1334706|NCT02016482|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26|Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with a given assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334707|NCT02016482|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26|The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334708|NCT02016482|Secondary|Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26|The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from –0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334709|NCT02016482|Secondary|Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26|"The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating fingernail psoriasis had no effect on this and 10 indicating fingernail psoriasis completely prevented me from this. A decrease in the WPAI:NPSO score indicates improvement."|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with given assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1335496|NCT02005211|Secondary|PK AUC - Overall Study (SAD & MAD Parts)|Pharmacokintic Area Under the Curve (0 to t)|0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|healthy Japanese participants|||hr.ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334710|NCT02016482|Secondary|Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||percentage of participants|||Number
1334711|NCT02016482|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334712|NCT02016482|Secondary|Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334713|NCT02016482|Secondary|Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334714|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334715|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334716|NCT02016482|Secondary|Percent Change From Baseline in Total BSA at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334717|NCT02016482|Secondary|Change From Baseline in Total Body Surface Area (BSA) at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of affected BSA||Standard Error|Least Squares Mean
1334718|NCT02016482|Secondary|Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26|The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had Baseline inverse psoriasis score ≥ 6. Inverse psoriasis was assessed for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.|||percentage of participants|||Number
1334719|NCT02016482|Secondary|"Percentage of Participants Achieving PGA-S of Clear at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1335918|NCT01997723|Other Pre-specified|Percentage of Participants Who Prefer Home Testing Over Laboratory Testing|Participants indicated which test (PM or PSG) they preferred.|1 week||||percentage of participants|||Number
1334720|NCT02016482|Secondary|"Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) Clear or Minimal at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) or minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1334721|NCT02016482|Secondary|Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline PASI score ≥ 5. Multiple imputation.|||percentage of participants|||Number
1334722|NCT02016482|Secondary|Percent Change From Baseline in PASI Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334723|NCT02016482|Secondary|Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334724|NCT02016482|Secondary|Change From Baseline in Total Fingernail NAPSI Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334725|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334726|NCT02016482|Secondary|Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334727|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1334728|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1334729|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334730|NCT02016482|Secondary|Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334982|NCT02013830|Secondary|Overall Survival|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT Population.|||months||95% Confidence Interval|Median
1334731|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
1334732|NCT02016482|Secondary|Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
1334733|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1334734|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1334735|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1334736|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Matrix Component of the PGA-F At Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail matrix component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail matrix component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail matrix component of moderate or worse. Multiple imputations."|||percentage of participants|||Number
1334737|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Bed Component of the PGA-F at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail bed component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail bed component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail bed component of moderate or worse. Multiple imputation."|||percentage of participants|||Number
1334738|NCT02016482|Secondary|Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26|The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Scalp psoriasis was assessed by B-SNIPI at Week 26 for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.|||percentage of participants|||Number
1334739|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.|||units on a scale||Standard Error|Least Squares Mean
1334740|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.|||percent change||Standard Error|Least Squares Mean
1334741|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1335358|NCT02007200|Secondary|The Number of Participants Alive at Follow-up|Overall survival at last follow-up will be determined.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.|||participants|||Number
1334742|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.|||percent change||Standard Error|Least Squares Mean
1334743|NCT02016482|Primary|"For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of Clear or Minimal at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of “clear” (0) or “minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
1334744|NCT02016482|Primary|Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.|Week 26|Intent-to-treat (ITT) Population in Period A: all participants who were randomized at Baseline.|||percentage of participants|||Number
1334745|NCT02016170|Secondary|Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP).|The secondary hypothesis of our study was that after 1 week of randomized treatment PRI levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel. VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies.|7 days||||PRI||Standard Deviation|Least Squares Mean
1334746|NCT02016170|Primary|Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay|The primary hypothesis of our study was that after 1 week of randomized treatment PRU levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel.|7 days|Analysis was conducted in patients who received the randomized treatment and had a valid primary end point value (PRU at 1 week).|||PRU||Standard Error|Least Squares Mean
1334747|NCT02016105|Secondary|ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51|"Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.~Patients with ADA positive results at baseline were excluded from subsequent results."|At Week 51 only|The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.|||% patients with at least 1 ADA+ sample|||Number
1334748|NCT02016105|Secondary|ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17|"Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.~Patients with ADA positive results at baseline were excluded from subsequent results."|At Week 17 only|The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.|||% patients with at least 1 ADA+ sample|||Number
1334749|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 51 only||||% of patients with DLQI of 0 or 1|||Number
1334750|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 35 only||||% of patients with DLQI of 0 or 1|||Number
1334751|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||% of patients with DLQI of 0 or 1|||Number
1334752|NCT02016105|Secondary|IGA Response Rate|Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 51|At Week 51 only||||percent of participants|||Number
1334753|NCT02016105|Secondary|IGA Response Rate|Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 51|At Week 35 only||||percent of participants|||Number
1334754|NCT02016105|Secondary|IGA Response Rate|Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 17.|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percent of participants|||Number
1334755|NCT02016105|Secondary|PASI 50, PASI75, PASI 90 and PASI100 Response Rates|Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)|At Week 51 only||||percent of participants|||Number
1334756|NCT02016105|Secondary|PASI 50, PASI75, PASI 90 and PASI100 Response Rates|Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)|At Week 35 only||||percent of participants|||Number
1334757|NCT02016105|Secondary|PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates|Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percent of participants|||Number
1334758|NCT02016105|Secondary|Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)|The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).|Baseline to Week 16|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percentage change from baseline||Standard Error|Least Squares Mean
1334759|NCT02016105|Secondary|Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)|The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.|Baseline to Week 16|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percentage change from baseline||Standard Error|Least Squares Mean
1334760|NCT02016105|Primary|PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab|The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.|At Week 16 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percent of participants|||Number
1334761|NCT02015910|Primary|Percent Wounds Healed|Compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.|12 weeks|Data analysis not completed due to insufficient enrollment.||||||
1334762|NCT02015793|Other Pre-specified|Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations >2 μg/mL.|Baseline (Week 0) to Week 8|ITT population.||||||
1334763|NCT02015793|Secondary|Fecal Calprotectin: Change From Baseline (Week 0) to Week 8|Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.|Baseline (Week 0) and Weeks 4 and 8|ITT population.|||μg/g||Full Range|Median
1334764|NCT02015793|Secondary|High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26|hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26|ITT population.|||mg/L||Full Range|Median
1334765|NCT02015793|Secondary|CDAI: Mean Change From Baseline to Each Visit|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.|||units on a scale||Standard Deviation|Mean
1334766|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.|||percentage of participants||95% Confidence Interval|Number
1334767|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.|||percentage of participants||95% Confidence Interval|Number
1334768|NCT02015793|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.~For more details on adverse events please see the AE section below."|35 weeks|Safety Analysis Set.|||participants|||Number
1334769|NCT02015793|Secondary|Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab|Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively.|26 weeks|Safety Analysis Set.|||participants|||Number
1334770|NCT02015793|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.|From Week 0 to Week 26|Safety Analysis Set.|||participants|||Number
1334983|NCT02013830|Secondary|Overall Survival - Percentage of Participants With an Event|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.|||percentage of participants|||Number
1334771|NCT02015793|Secondary|Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|26 weeks|Safety Analysis Set: all participants who received at least 1 dose of study drug.|||participants|||Number
1334772|NCT02015793|Primary|Mean Serum Adalimumab Concentration at Week 8|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.|Week 8|All participants in the intent-to-treat (ITT) population, defined as all randomized participants who received at least 1 dose of double-blind study drug, who had evaluable data.|||μg/mL||Standard Deviation|Mean
1334773|NCT02015754|Other Pre-specified|Exploratory Endpoint - Angiogenesis|Changes in vascular endothelial growth factors (VEGF), VEGF receptors VEGFR1 and VEGFR2 pre- and post- DEBIRI treatment examined for significant effects as well as association with DEBIRI treatment. One-sample Wilcoxon signed rank test was utilized to compare whether %change of VEGF, VEGFR1, or VEGFR2 from baseline was equal to 0. For groups with non-zero percent changes, the 95% confidence intervals were provided.|24 hours||||% change from baseline||95% Confidence Interval|Median
1334774|NCT02015754|Other Pre-specified|Plasma Half-life of Irinotecan and SN-38 Post DEBIRI-TACE|Plasma half-life (t 1/2) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||hours||Standard Deviation|Median
1334775|NCT02015754|Other Pre-specified|Exploratory Endpoint -Tmax of Irinotecan and SN-38 Post DEBIRI-TACE|Time taken to reach maximum concentration (Tmax) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||hours||Standard Deviation|Median
1334776|NCT02015754|Other Pre-specified|Exploratory Endpoint -Total Drug Exposure Over Time (AUC) of Irinotecan and SN-38 Post DEBIRI-TACE|Total drug exposure over time (AUC) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||ng*h/mL||Standard Deviation|Mean
1334777|NCT02015754|Other Pre-specified|Exploratory Endpoint - Pharmacokinetic (PK) Profile of Irinotecan and SN-38 Post DEBIRI-TACE|PK analysis of irinotecan and its metabolite SN-38 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax). Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||ng/mL||Standard Deviation|Median
1334778|NCT02015754|Secondary|One-year Survival Percentage|Percentage of study patients surviving after one year from initial treatment analyzed with Kaplan-Meier curve.|1 year||||percentage of participants|||Number
1334779|NCT02015754|Secondary|Median Overall Survival|Median overall survival from start of therapy (DEBIRI #1) until death (or date of censor).|Up to 26 months||||months||Full Range|Median
1334780|NCT02015754|Secondary|Number of Participants With Change in Carcinoembryonic Antigen (CEA)|CEA measurements pre- and post- DEBIRI treatment will be recorded to ascertain if it is predictive of survival.|6 weeks|2 out of original 14 patients had no CEA measurements.|||participants|||Number
1334781|NCT02015754|Secondary|Efficacy - Tumor Response by World Health Organization (WHO) Criteria|"Efficacy as assessed by radiographic tumor response using WHO criteria at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): No lesions detected for at least 4 weeks. Partial Response (PR): 50% or greater decrease in the sum of the products of diameters Stable Disease (SD): Cases that do not fit the criteria of PR or PD. Progressive Disease (PD): 25% or greater increase in the sum of the products of diameters in one or more lesions; or new lesions"|24 weeks||||Participants|||Count of Participants
1334782|NCT02015754|Secondary|Efficacy -Tumor Response by European Association for the Study of the Liver (EASL) Criteria|"Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBIRI-M1. Baseline degree of tumor enhancement used as a reference.~Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBIRI-M1.~Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBIRI-M1.~Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBIRI-M1."|24 weeks||||Participants|||Count of Participants
1334783|NCT02015754|Secondary|Efficacy - Tumor Response by mRECIST|"Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started.~Stable Disease (SD): Any cases that do not qualify for either PR or PD."|24 weeks||||Participants|||Count of Participants
1334784|NCT02015754|Secondary|Efficacy - Tumor Response by RECIST|"Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): Disappearance of all lesions targeted by DEBIRI-M1 Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of lesions targeted by DEBIRI-M1, taking as reference the baseline sum LD Progressive Disease (PD): At least 20% increase in sum of the LD Of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD since treatment started"|24 weeks||||Participants|||Count of Participants
1335497|NCT02005211|Secondary|PK Cmax - Overall Study|Pharmacokinetic maximum concentration|0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|Pharmacokinetic|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334785|NCT02015754|Primary|Safety, Defined as Demonstrating Tolerable Device-related Toxicity Profile in the Use of DEBIRI Beads Used to Treat Hepatic Metastases in Patients With Colorectal Cancer|Toxicities assessed as being at least possibly related will be recorded including system organ class, subclass, grade, frequency and time interval from DEBIRI-M1.|6 weeks|6-week toxicity report of device-related adverse events for all 14 participants. Classification and grading based on CTCAE v4.0.|||Participants|||Count of Participants
1334786|NCT02015754|Primary|Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments)|Feasibility is defined as achieving an acceptable level of technical success in the use of DEBIRI beads treating hepatic metastases in patients with colorectal cancer.|6 months|The 14 patients received a total of 32 DEBIRI-M1 TACE procedures.|||percentage of successful treatments|DEBIRI-M1 Treatments||Number
1334787|NCT02015676|Secondary|Overall Survival|The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||Standard Error|Mean
1334788|NCT02015676|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
1334789|NCT02015676|Secondary|Time to Therapy Failure|The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
1334790|NCT02015676|Secondary|Time to Therapy Failure - Percentage of Participants With an Event|Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
1334791|NCT02015676|Secondary|Duration of Response|The median time, in months, from enrollment to duration of response event to Week 52.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
1334792|NCT02015676|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|Only participants with a response were included in the analysis.|||percentage of participants|||Number
1334793|NCT02015676|Secondary|Time to Treatment Response|The median time, in months, from the start of treatment to treatment response event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
1334794|NCT02015676|Secondary|Time to Treatment Response - Percentage of Participants With an Event|Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage participants|||Number
1334795|NCT02015676|Secondary|Time to Disease Progression|The median time, in months, from the start of treatment to disease progression event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
1334796|NCT02015676|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
1334797|NCT02015676|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment|For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.|Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
1336841|NCT01982435|Secondary|Participants With BCVA at 20/40 or Better|Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12.|Months 6 and 12||||Participants|||Count of Participants
1334798|NCT02015663|Secondary|Change From Baseline in Tobramycin Minimal Inhibitory Concentration for Pseudomonas Aeruginosa|Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa will be measured by laboratory testing.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334799|NCT02015663|Secondary|Duration of Use of Anti-pseudomonal Antibiotic|Number of days of use of anti-pseudomonal antibiotic per patient will be assessed.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334800|NCT02015663|Secondary|Percentage of Patients Who Use Anti-pseudomonal Antibiotic|Percentage of patients who use anti-pseudomonal antibiotic will be assessed.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334801|NCT02015663|Secondary|Time to First Usage of Anti-pseudomonal Antibiotic|Time to first usage of anti-pseudomonal antibiotic per patient will be assessed by number of days|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334802|NCT02015663|Secondary|Length of Hospital Stay Due to Respiratory-related Events|The number of days in length of hospital stay per patient due to respiratory-related events will be measured.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334803|NCT02015663|Secondary|Percentage of Patients With Hospitalizations Due to Respiratory-related Events|Percentage of patients with hospitalization due to respiratory-related events|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334804|NCT02015663|Secondary|Time to First Hospitalization Due to Respiratory-related Events|Time to the first hospitalization due to respiratory-related events (number of days) per patient.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334805|NCT02015663|Secondary|Change From Baseline in Pseudomonas Aeruginosa Sputum Density|Change from baseline in Pseudomonas aeruginosa sputum density will be measured by log10 colony forming units per gram of sputum.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334806|NCT02015663|Secondary|Percent Change From Baseline in Forced Expiratory Flow (FEF) 25%-75% Predicted|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function. The predicted percent will be assessed.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334807|NCT02015663|Secondary|Percent Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334808|NCT02015663|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|"The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function."|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334809|NCT02015663|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second ( FEV1) Percent Predicted|"The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function."|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
1334810|NCT02015637|Secondary|Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population|Cure for the seconday outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.|Day 7 (± 3 days)|Urogenital ME (UME): All subjects included in the UMITT analysis set who received study drug and had no important protocol deviations that would affect the assessment of efficacy|||Participants|||Count of Participants
1334811|NCT02015637|Primary|Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population|Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.|Day 7 (± 3 days)|The primary efficacy analysis was done on the UMITT population, which included all subjects in the ITT analysis set who had a positive culture for N gonorrhoeae obtained at a urogenital site at the Entry Visit, and who did not receive antibiotic therapy for a C trachomatis infection that was potentially effective against N gonorrhoeae prior to TOC.|||Participants|||Count of Participants
1334812|NCT02015546|Secondary|MADRS Remission|MADRS remission is defined as MADRS score < 10|Week 8||||participants|||Number
1334813|NCT02015546|Secondary|MADRS Response|Number of subjects who had a ≥ 50% decrease in MADRS score from baseline|Baseline, Week 8||||participants|||Number
1334814|NCT02015546|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, 8 week||||units on a scale||Standard Deviation|Mean
1334815|NCT02015546|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Baseline, Week 8||||units on a scale||Standard Deviation|Mean
1334816|NCT02015546|Secondary|Change in Sheehan Disability Scale (SDS)|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline, 8 week||||units on a scale||Standard Deviation|Mean
1334817|NCT02015546|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks||||units on a scale||Standard Deviation|Mean
1334818|NCT02015546|Primary|Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Baseline, Weeks 8||||units on a scale||Standard Deviation|Mean
1334819|NCT02015546|Primary|Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary.~Total possible range is 0 to 172. A higher score indicates more symptoms."|Baseline, week 9||||units on a scale||Standard Deviation|Mean
1334820|NCT02015546|Primary|Change in Total MADRS Scores From Baseline to Week 8|The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline, Week 8||||units on a scale||Standard Deviation|Mean
1334821|NCT02015481|Secondary|SWAL-QOL, Swallowing Quality of Life Questionnaire|Summary of Quality of Life in Swallowing Disorders total symptom score results over time, change from baseline at weeks 12 and 24 This is a 100 point scale. The higher the number the better the quality of life.|28 weeks||||percentage change from baseline||Standard Deviation|Mean
1334822|NCT02015481|Secondary|Videofluoroscopy (VFS) Score|Penetration aspiration score results assessed by VFS comparing baseline, prior to treatment, to week 24. This is an 8 point scale. The higher the number the greater the risk of aspiration. The result reported is the difference from the baseline scores.|24 Weeks|11 patients had valid baseline data and week 24 data|||Points on an 8 point scale||Standard Deviation|Mean
1334823|NCT02015481|Secondary|Drinking Test Score|Change from baseline in ice water drinking time, in seconds, at week 24. Times greater than 8 seconds to complete the drinking test are considered abnormal.|24 weeks|22 patients had data available for analysis at week 24|||percentage change from baseline||Standard Deviation|Mean
1334824|NCT02015481|Primary|Safety Lab Evaluations|Change from baseline in safety labs including hematology, coagulation, chemistry, renal function, and liver function tests at week 24 .|24 weeks|24 patients were available for analysis at week 24. Not all patients had all labs performed. Missing data accounts for the differing number of patients with specific lab values.|||percentage change from baseline||Standard Deviation|Mean
1334825|NCT02015234|Secondary|Responder Analysis of Patient's Global Impression of Change (PGIC)|"PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse"|Months 1, 3, 6, 9, 12|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. Overall, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study early. Any missing PGIC responses were included in the “scores 3-7” for that visit.|||Participants|||Count of Participants
1334826|NCT02015234|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall|The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.|Month 1, 3, 6, 9, 12|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.|||Scores on a scale||Standard Deviation|Mean
1334827|NCT02015234|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall|The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.|Months 1, 3, 6, 9 and 12.|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.|||Scores on a scale||Standard Deviation|Mean
1334828|NCT02015234|Primary|Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.|NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).|Up to 12 months|All of the 158 enrolled patients took at least 1 dose of study drug and were included in the safety analysis population.|||Participants|||Count of Participants
1334829|NCT02015221|Primary|Ease of Use and Comfort for Subjects Using the ACTitouch System.|Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.|30 days||||Percent of participants|Participants|95% Confidence Interval|Number
1334830|NCT02015195|Primary|Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours|"Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with 0 representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a scale from -20 to +20 with 0 being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the treatment arm was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20)."|30 minutes, 1 hour, and 24 hours||||units on a scale||95% Confidence Interval|Mean
1334831|NCT02015195|Primary|Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours|"Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The mean change for the treatment arm was then compared with the mean change for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group."|24 hours|one participant excluded because of adverse local skin reaction to household ammonia|||units on a scale||95% Confidence Interval|Mean
1334832|NCT02015039|Secondary|Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 24 Weeks.|"A visual analogue scale was used to rate patient's subjective rating of the severity of their writer's cramp at each visit. Patients were asked to mark the location on a 10 centimeter line corresponding to the severity of their writer's cramp. Ratings ranged from mild disease severity to severe disease severity. The mark was measured on the 10 centimeter line, ranging from 0 to 10. The percent change in the patient rated subject scale was measured at baseline (Visit 1) and 24 weeks (Visit 9) in the two groups."|Baseline and 24 weeks|The patient rated subjective scale was not administered at baseline in two subjects, i.e., one subject in each group, therefore these subjects were not included in the analysis.|||percentage of change||Standard Deviation|Mean
1334833|NCT02015039|Secondary|Change in Quantitative Writing Metrics Obtained Via Numerical Analyses of Writing Samples Using a Digitizing Tablet.|Subjects with writer's cramp were instructed to draw with their dominant hand between the lines of a 5-loop Archimedes spiral presented on a paper placed over the surface of a digitizing tablet sampling pen tip position at a 100 Hz. The deviation of the drawn spiral to the ideal spiral was calculated at each sampled point. The root mean square of the total spiral error was used as a measure of dysfunctional pen control in subjects with writer's cramp compared with normative data. The percent change of the root mean square was calculated at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.|Baseline and 20 weeks||||percentage of change||Standard Deviation|Mean
1334834|NCT02015039|Secondary|Change in Hand Grip Strength From Baseline to 20 Weeks Following Botulinum Toxin Therapy Alone and Botulinum Toxin Therapy Plus Occupational Therapy.|Hand grip strength was measured using a commercially available dynamometer. The dynamometer instrument measures maximum isometric strength of the hand and forearm muscles. Hand grip strength was measured with the dynamometer during each visit. The percent change in hand grip strength between baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.|Baseline and 20 weeks||||percentage of change||Standard Deviation|Mean
1334835|NCT02015039|Secondary|Change on the Writer's Cramp Disability Scale (WCDS) Score From Baseline to 20 Weeks.|The Writer’s Cramp Disability Scale (WCDS) is a self-reported questionnaire which queries patients regarding problems they experience with writing and other every day activities due to writer’s cramp. The scale ranges from 0-42 with 0 representing “no difficulty” and 42 representing “marked difficulty”. The percent change in the WCDS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.|Baseline and 20 weeks|The Writer's Cramp Disability Scale (WCDS) was not administered at baseline for one subject in the Botulinum Toxin Therapy Only group therefore this subject was not included in the analysis.|||percentage of change||Standard Deviation|Mean
1334836|NCT02015039|Secondary|Change on the Writer's Cramp Impairment Scale (WCIS) Score From Baseline to 20 Weeks.|"The Writer's Cramp Impairment Scale (WCIS) scale assesses the speed of writing, the number of breaks during writing, the occurrence and intensity of involuntary (pathological) postures/abnormal movements (while writing, while performing repetitive wrist movements), the degree of tremor that occurs while performing repetitive spiral movements, and the presence of mirror movements. The scale ranges from 0-180 with 0 representing no impairment and 180 representing severe impairment. The percent change in the WCIS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups."|Baseline and 20 weeks|The Writer's Cramp Impairment Scale (WCIS) was not collected at week 20 for two subjects in the Botulinum Toxin Therapy plus Occupational Therapy group, therefore these two subjects were not included in the analysis.|||percentage of change||Standard Deviation|Mean
1334837|NCT02015039|Secondary|Change in the Writers Cramp Rating Scale (WCRS) From Baseline to Week 20 in Participants Receiving Botulinum Toxin Therapy Alone Compared With Botulinum Toxin Therapy Plus Occupational Therapy.|"The Writers Cramp Rating Scale (WCRS) is a tool used to quantify the treatment effect of local botulinum toxin injections in writer's cramp using writing performance and a computer assisted analysis of writing speed. The WCRS consists of two parts. Part A provides a writing movement score measuring 1) dystonic posture elbow score (ES: 0-2), 2) wrist score (WRS: 0-4), 3) finger score (FS: 0-6), 4) latency of dystonia (L: 1-2) and 5) writing tremor (WT: 0-2). The writing movement sub-score is calculated as (ES + WRS + FS) x L + (WT x 2) (0-28). Part B provides an assessment of writing speed (WS: 0-2). The WCRS score is the total of the writing movement sub-score and the writing speed sub-score. The total WCRS range is between 0 indicating absent residual writer's cramp symptoms to 30 indicating severe writer's cramp symptoms. The percentage change in the WCRS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups."|Baseline and 20 weeks||||percentage of change||Standard Deviation|Mean
1334838|NCT02015039|Primary|Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 20 Weeks.|"A visual analogue scale was used to rate patient's subjective rating of the severity of their writer's cramp at each visit. Patients were asked to mark the location on a 10 centimeter line corresponding to the severity of their writer's cramp. Ratings ranged from mild disease severity to severe disease severity. The mark was measured on the 10 centimeter line, ranging from 0 to 10. The percent change in the patient rated subject scale was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups."|Baseline and 20 weeks|The patient rated subjective scale was not administered at baseline in two subjects, i.e., one subject in each group, therefore these subjects were not included in the analysis.|||percentage of change||Standard Deviation|Mean
1334839|NCT02014740|Primary|Echocardiographic Epicardial Fat Thickness|Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.|6 months||||mm||Standard Deviation|Mean
1334840|NCT02014584|Secondary|Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period|The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the OL treatment start.|Baseline and up to Week 24|open-label period population|||Participants|||Number
1334841|NCT02014584|Secondary|Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period|The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the DB treatment start.|Baseline and up to Week 24|Safety Population|||Participants|||Number
1334842|NCT02014584|Secondary|Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period|The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline and Upto Week 24|Open-label Period Population|||Scores on a Scale||Standard Deviation|Mean
1334843|NCT02014584|Secondary|Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period|The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
1334844|NCT02014584|Secondary|Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period|The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7=very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-label Period Population|||Scores on a Scale||Standard Deviation|Mean
1334845|NCT02014584|Secondary|Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period|The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7= very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
1334846|NCT02014584|Secondary|Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Open-label Period Population|||Scores on a Scale||Standard Deviation|Mean
1334847|NCT02014584|Secondary|Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
1334848|NCT02014584|Secondary|Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Open-Label Period Population|||Scores on a Scale||Standard Deviation|Mean
1334849|NCT02014584|Secondary|Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
1334859|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period|Clinical chemistry parameters included: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||IU/L||Standard Deviation|Mean
1335567|NCT02004158|Primary|Ease of Exercises|Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.|8 weeks||||scores on a scale||Standard Deviation|Mean
1334850|NCT02014584|Secondary|Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline, Week 4, Week 12 and Week 24|Open-Label Period Population|||Participants|||Number
1334851|NCT02014584|Secondary|Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline, Week 4, Week 12 and Week 24|Safety Population|||Participants|||Number
1334852|NCT02014584|Secondary|Incidence of Premature Discontinuations in the Open-label Treatment Period|Participants were referred as premature discontinuations if they do not complete the open-label treatment period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.|Week 48|ITT population|||Participants|||Number
1334853|NCT02014584|Secondary|Incidence of Premature Discontinuations in the Double-blind Treatment Period|Participants were referred as premature discontinuations if they do not complete the double-blind period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.|Week 24|ITT population|||Participants|||Number
1334854|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN.|Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||MMOL/L||Standard Deviation|Mean
1334855|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||MMOL/L||Standard Deviation|Mean
1334856|NCT02014584|Secondary|Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin.|Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||UMOL/L||Standard Deviation|Mean
1334857|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin|Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||UMOL/L||Standard Deviation|Mean
1334858|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period|Clinical chemistry parameters included: ALT, ALP, AST, and GGT at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||IU/L||Standard Deviation|Mean
1334870|NCT02014584|Secondary|Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period|Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).|Baseline and up to Week 24|Open-Label Period Population|||Participants|||Number
1334860|NCT02014584|Secondary|Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein|Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||G/L||Standard Deviation|Mean
1334861|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein|Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||G/L||Standard Deviation|Mean
1334862|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count|Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||T/L||Standard Deviation|Mean
1334863|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count|Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||T/L||Standard Deviation|Mean
1334864|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin|Hematology parameters included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||G/L||Standard Deviation|Mean
1334865|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin|Hematology parameter included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||G/L||Standard Deviation|Mean
1334866|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit|Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||Proportion of RBCs||Standard Deviation|Mean
1334867|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit|Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||Proportion of RBCs||Standard Deviation|Mean
1334868|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period|Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||Giga per Liter (GI/L)||Standard Deviation|Mean
1334869|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period|Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||Giga per Liter (GI/L)||Standard Deviation|Mean
1334872|NCT02014584|Secondary|Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).|Baseline and up to Week 24|Open-Label Period Population|||Participants|||Number
1334873|NCT02014584|Secondary|Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).|Baseline and up to Week 24|Safety Population|||Participants|||Number
1334874|NCT02014584|Secondary|Change From Baseline in Heart Rate in the Open-label Treatment Period|Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Open-Label Period Population|||Beats per Minute||Standard Deviation|Mean
1334875|NCT02014584|Secondary|Change From Baseline in Heart Rate in the Double-blind Treatment Period|The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||Beats per Minute||Standard Deviation|Mean
1334876|NCT02014584|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period|Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Open-Label Period Population|||mmHg||Standard Deviation|Mean
1334877|NCT02014584|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1334878|NCT02014584|Secondary|Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period|Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .|24 weeks|Safety Population|||Participants|||Number
1334879|NCT02014584|Secondary|Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period|Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .|24 weeks|Safety Population|||Participants|||Number
1334880|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
1334881|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|24 weeks|Open-Label Period Population|||Participants|||Number
1334882|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|24 weeks|Safety Population|||Participants|||Number
1334883|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
1334884|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.|24 weeks|Open-Label Period Population|||Participants|||Number
1334885|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.|24 weeks|Safety Population|||Participants|||Number
1334886|NCT02014584|Secondary|Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
1334887|NCT02014584|Secondary|Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|24 weeks|Open-Label Period Population|||Participants|||Number
1334888|NCT02014584|Secondary|Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|24 weeks|Safety Population|||Participants|||Number
1334889|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
1334890|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Open-Label Period Population|||Participants|||Number
1334891|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Safety Population|||Participants|||Number
1334892|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|48 weeks|Dutasteride DB/OL Combined population|||Days||Standard Deviation|Mean
1334893|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|24 weeks|Safety Population|||Days||Standard Deviation|Mean
1334894|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|24 weeks|Safety Population|||Days||Standard Deviation|Mean
1334895|NCT02014584|Primary|Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|48 weeks|Dutasteride DB/OL Combined: all participants who entered the OL Period and taken Dutasteride in both the DB and the OL periods.|||Participants|||Number
1334896|NCT02014584|Primary|Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Open-Label Period Population: all participants who entered the open-label period.|||Participants|||Number
1334897|NCT02014584|Primary|Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Safety Population: all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1334898|NCT02014480|Secondary|Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 81)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
1334899|NCT02014480|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 85)|ITT Population. Only those participants available at the indicated time point were assessed.|||participants|||Number
1334900|NCT02014480|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC or, VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.’s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 66)|ITT Population|||participants|||Number
1334901|NCT02014480|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP.|Baseline and Day 14 of each treatment period (up to study day 85)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
1334902|NCT02014467|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, serious non-fatal AEs, serious fatal AEs have been presented.|From start of IP through the Study Phase (6 months post-dose) (assessed up to 12 months)|Safety Population. Two participants randomized to placebo group received denosumab by mistake.|||Participants|||Number
1334903|NCT02014467|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Baseline and Month 12|Anti-denosumab antibody formation was assessed at Baseline (Visit 3) and Month 12. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody.|Baseline and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1334904|NCT02014467|Secondary|Change From Baseline in Red Blood Cell Count at Month 6 and Month 12|Baseline value was obtained at screening (visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as: Value at Indicated visit minus Baseline value. Blood samples were collected for measurement. Red blood cell count was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Trillion cells per liter (TI/L)||Standard Deviation|Mean
1334905|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Volume at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle volume was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Femtoliter (FL)||Standard Deviation|Mean
1334906|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle hemoglobin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Picograms (PG)||Standard Deviation|Mean
1334907|NCT02014467|Secondary|Change From Baseline in Hematocrit at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Hematocrit was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Ratio||Standard Deviation|Mean
1334908|NCT02014467|Secondary|Change From Baseline in Creatinine and Uric Acid at Month 6 and Month 12|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatinine and uric acid were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
1334909|NCT02014467|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Direct bilirubin and total bilirubin were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
1334910|NCT02014467|Secondary|Change From Baseline in Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen (BUN) at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Chloride, cholesterol, glucose, magnesium, inorganic phosphorous, potassium, sodium, triglycerides and urea/BUN were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1334911|NCT02014467|Secondary|Change From Baseline in Calcium (Corrected), Calcium at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Calcium (corrected) and calcium were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1334912|NCT02014467|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils-total Absolute Neutrophil Count (ANC), White Blood Cell Count at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils-total ANC and white blood cell count were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Giga per liter (GI/L)||Standard Deviation|Mean
1334913|NCT02014467|Secondary|Change From Baseline in Hemoglobin and Total Protein at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Hemoglobin and total protein were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Grams per liter (G/L)||Standard Deviation|Mean
1334914|NCT02014467|Secondary|Change From Baseline in Globulin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Globulin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Grams per liter (G/L)||Standard Deviation|Mean
1334915|NCT02014467|Secondary|Change From Baseline in Albumin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Albumin was assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Gram per liter (G/L)||Standard Deviation|Mean
1334916|NCT02014467|Secondary|Change From Baseline in Creatine Kinase, Lactate Dehydrogenase at Month 6 and Month 12.|Baseline values was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatine kinase and lactate dehydrogenase were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||International unit per liter (IU/L)||Standard Deviation|Mean
1334917|NCT02014467|Secondary|Change From Baseline in Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Month 1, Month 6 and Month 12|Baseline values were obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Alanine amino transferase, alkaline phosphatase, aspartate amino transferase, and gamma glutamyl transferase were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6, and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||International unit per liter (IU/L)||Standard Deviation|Mean
1334918|NCT02014467|Secondary|Change From Baseline in Heart Rate at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in heart rate was assessed at Baseline, Month 1, Month 3, Month 6 and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Beats per minute||Standard Deviation|Mean
1335225|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
1334919|NCT02014467|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in SBP and DBP was assessed at Baseline, Month 1, Month 3, Month 6, and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population: all participants who received at least one dose of study medication. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1334920|NCT02014467|Secondary|Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline to Month 6 and Month 12|s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in serum CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6, Month 12|ITT Population: Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).|||Percentage change||Inter-Quartile Range|Median
1334921|NCT02014467|Secondary|Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline to Month 6 and Month 12|s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in s-CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6 and Month 12|ITT Population. Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).|||Percentage change||Inter-Quartile Range|Median
1334922|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334923|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334924|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334925|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334984|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants Progression-free at 12 Months|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.|||percentage of participants||95% Confidence Interval|Number
1334926|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334927|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334928|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Lumbar Spine at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334929|NCT02014467|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12|Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|Intent-to-Treat (ITT) Population: all safety Population participants (consisting of all participants who received at least one dose of study medication) who had a Baseline and at least one valid post-Baseline efficacy measure. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
1334930|NCT02014441|Secondary|Number of Participants With Adverse Events (AEs)|The Common Terminology Criteria for Adverse Events version 3.0 was used to grade severity of adverse events, based on the following general guideline: Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. A serious adverse event was defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event Treatment-related adverse events (TRAEs) are defined as adverse events possibly caused by talimogene laherparepvec, as assessed by the investigator.|From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median treatment duration was 21.1 weeks.|All participants who received at least 1 dose of talimogene laherparepvec.|||participants|||Number
1334931|NCT02014441|Secondary|Overall Survival|Overall Survival (OS) was defined as the interval from first dose of talimogene laherparepvec to death from any cause; participants still alive were censored at the last known alive date.|From first dose of talimogene laherparepvec up to the data cut-off date. The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
1334932|NCT02014441|Secondary|Durable Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Durable response rate is defined as the percentage of participants with a complete response or partial response maintained continuously for at least 6 months (183 days).~Complete response: disappearance of all index and non-index lesions. Partial Response:≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
1335264|NCT02008617|Secondary|Pain Score|Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.|Pain Burden at 24hrs||||units on a scale||Inter-Quartile Range|Median
1334933|NCT02014441|Secondary|Duration of Response|Duration of response (DOR) was calculated only for those participants with an objective response and defined as the longest interval from an initial objective response (complete response or partial response) to disease progression per the modified WHO criteria or death, whichever occurred earlier; otherwise, DOR was censored at the last evaluable tumor assessment for participants who did not die or progress.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec and had an objective response.|||months||95% Confidence Interval|Median
1334934|NCT02014441|Secondary|Time to Response|Time to response was defined as the interval from the first dose of talimogene laherparepvec to the first event of complete response or partial response per modified WHO criteria; participants who did not respond were censored at the last evaluable tumor assessment.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
1334935|NCT02014441|Secondary|Objective Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Objective response rate is defined as the percentage of participants with either a complete response or partial response. Subsequent confirmation was not required.~Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and thenat least every 3 months up to 6 months after end of treatment; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
1334936|NCT02014441|Secondary|Best Overall Response|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound of the chest, abdomen, and pelvis and all other sites of disease).~Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions.~Stable disease: Neither sufficient tumor shrinkage of index lesion to qualify for response nor sufficient tumor increase of index lesion to qualify for progressive disease, assessed a minimum interval of 77 days from the first dose of study drug.~Progressive Disease: ≥ 25% increase in size of index lesions or appearance of one or more non-index lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to 6 months after end of treatment; median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||participants|||Number
1334937|NCT02014441|Secondary|Number of Samples With Detectable Talimogene Laherparepvec in Lesions Suspected to be Herpetic in Origin|Any lesion such as a cold sore or vesicle thought to be herpetic in origin was evaluated by the investigator and swabbed if HSV infection was suspected. Quantitative PCR was performed on the swab sample to evaluate whether talimogene laherparepvec DNA was detectable in the sample.|From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 21.0 weeks (range: 3 to 73 weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions suspected to be herpetic in origin during the study.|||samples|samples||Number
1334938|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.||||||
1334939|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment.|||percentage of participants|||Number
1334940|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.||||samples||
1334941|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after end of treatment.|||percentage of samples|samples||Number
1334985|NCT02013830|Secondary|Time to Disease Progression|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Intent-To-Treat (ITT) Population included all enrolled participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
1334942|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa after the end of treatment treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.||||||
1334943|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs taken from oral mucosa after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.|||percentage of participants|||Number
1334944|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.||||samples||
1334945|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA after the end of treatment is reported.|30 to 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.|||percentage of samples|samples||Number
1334946|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. Results for TCID50 for swabs of the anogenital area were not available as of the data cutoff date.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.||||||
1334947|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.|||percentage of participants|||Number
1334948|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. Results for TCID50 for swabs of the anogenital area were not available as of the data cutoff date.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.||||samples||
1334949|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA at any time during treatment (cycles 1 - 37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.|||percentage of samples|samples||Number
1334950|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.|||percentage of participants|||Number
1334951|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.|||percentage of participants|||Number
1335265|NCT02008617|Primary|Opioid Consumption|Opioid consumption (mg morphine equivalents)|24 hours||||mg morphine equivalents||Inter-Quartile Range|Median
1334952|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus at any time during treatment (cycles 1-37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.|||percentage of samples|samples||Number
1334953|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA at any time during treatment (cycles 1 - 37) is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 37) on day 1 (pre-dose), cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.|||percentage of samples|Samples||Number
1334954|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Surface of Injected Lesions|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.|||percentage of participants|||Number
1334955|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Surface of Injected Lesions|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.|||percentage of participants|||Number
1334956|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec Virus|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from the surface of injected lesions with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.|||percentage of samples|samples||Number
1334957|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec DNA|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the surface of injected lesions with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.|||percentage of samples|Samples||Number
1334958|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.|||percentage of participants|||Number
1334959|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.|||percentage of participants|||Number
1334960|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.|||percentage of samples|samples||Number
1335119|NCT02012582|Post-Hoc|Extended Glasgow Outcome Score (eGOS)|"Scoring: Range from 1 (worst outcome) to 8 (good outcome). The patient´s overall rating is based on the lowest outcome category indicated on the scale.~Score Description~Dead~Vegetative State~Lower Severe Disability~Upper Severe Disability~Lower Moderate Disability~Upper Moderate Disability~Lower Good Recovery~Upper Good Recovery"|6 months after start of treatment||||units on a scale||Full Range|Median
1334961|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.|||percentage of samples|samples||Number
1334962|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine|A participant was defined as having cleared talimogene laherparepvec if a negative urine sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose urine samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.|||percentage of participants||95% Confidence Interval|Number
1334963|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood|A participant was defined as having cleared talimogene laherparepvec if a negative blood sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants must have received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose blood samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.|||percentage of participants||95% Confidence Interval|Number
1334964|NCT02014441|Primary|Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least 1 dose of talimogene laherparepvec, and had at least 1 postdose blood/urine sample collected.|||percentage of participants||95% Confidence Interval|Number
1334965|NCT02014402|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments or maneuvers at the target bleeding site after the start of treatment|From start of treatment up to surgical closure by layers of the exposed surgical field containing the TBS, a median of 34 minutes|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population|||percent of subjects|||Number
1334966|NCT02014402|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:~At 3 minutes following start of study treatment~At 4 minutes following start of study treatment"|From start of treatment until 4 minutes after treatment start|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population|||percent of subjects achieving hemostasis|||Number
1334967|NCT02014402|Primary|Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS|Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure|From start of treatment until 5 minutes after treatment start|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the modified intent-to-treat (mITT) population|||percent of subjects achieving hemostasis|||Number
1334968|NCT02014363|Primary|Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment.|The mean difference in baseline-adjusted MADRS score at the end of treatment in the per protocol population using the last observation carried forward (LOCF) method. MADRS is used to assess the range of symptoms that are most frequently observed in patients with major depression. The MADRS test includes 10 items and uses a 0 to 6 severity scale, with higher scores indicating increasing depressive symptoms. The total MADRS score is derived by adding all the scores from the 10 items, meaning the lowest possible score is 0 and the highest possible is 60.|Baseline (start of randomized treatment) and 8 weeks post start of treatment|Per protocol population (all subjects of the full analysis set for whom no relevant protocol deviations were documented).|||Scores on a scale||Standard Error|Least Squares Mean
1334969|NCT02014272|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/ greater than [>] 1.5*limit of reference range [LRR]); platelets (<0.5/>1.75*LRR); neutrophils, lymphocytes (<0.8/>1.2*LRR); eosinophils, basophils, monocytes (>1.2*upper LN [ULN]); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN); creatinine, urea (>1.3*ULN); fasting glucose (<0.6 />1.5*LRR); uric acid (>1.2*ULN); sodium (<0.95/>1.05*LRR); potassium, calcium, chloride, bicarbonate (<0.9/>1.1*LRR); albumin, total protein (<0.8/>1.2*LRR); creatine kinase (>2.0*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs) (>=20 high-powered field). Total number of participants with any laboratory abnormalities was reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1334986|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|ITT population.|||percentage of participants|||Number
1334970|NCT02014272|Other Pre-specified|Number of Participants With Clinically Significant Changes in Vital Signs|Criteria for clinical significant change in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or greater than (>) 120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum change from baseline in systolic BP >=30 mmHg, maximum change from baseline in diastolic BP >=20 mmHg. Participants who met the criteria were reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
1334971|NCT02014272|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.|||hour||Full Range|Median
1334972|NCT02014272|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half life (t1/2) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable t½ values, respectively.|||hour||Standard Deviation|Mean
1334973|NCT02014272|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) was reported for rifampicin and isoniazid. It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable AUC (0 - ∞) values, respectively.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1334974|NCT02014272|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1334975|NCT02014272|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.|||(nanogram*hour) per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1334976|NCT02014051|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 18 weeks|||||||Number
1334977|NCT02014051|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)|"Definition~Hematologic Improvement Erythrocyte (HI-E):~Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation~Hematologic Improvement Platelet (HI-P):~Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%~Hematologic Improvement Neutrophil (HI-N):~At least 100% increase and an absolute increase > 0.5×10^9/L~Progressive disease / Relapse:~At least 1 of the following:~At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 18 weeks||||participants|||Number
1334978|NCT02014051|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)|"Definition~Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%~Partial remission (PR) Same as CR except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%~Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR~Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 weeks Disease progression~Patients with:~Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts~Any of the following:~At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks||||participants|||Number
1334979|NCT02014051|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 1. DLTs were also assessed in the Efficacy and Safety Assessment Committee.~Criteria~Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhoea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhoea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)~Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 21 days||||participants|||Number
1334980|NCT02014051|Primary|Adverse Events|Total Number Affected by Any Adverse Event (Details are presented in Adverse Event section)|Up to 18 weeks||||participants|||Number
1335266|NCT02008526|Secondary|HIV Primary Care|HIV-positive participants will be assessed according to their linkage/retention in HIV primary care and adherence to ART medication at 8-weeks, 3-, 6-, and 9-months post-randomization.|8-weeks post randomization, 3-/6-/9-months post randomization|||||||
1334987|NCT02013830|Secondary|Percentage of Participants With Disease Control|The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|PP population.|||percentage of participants||95% Confidence Interval|Number
1334988|NCT02013830|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Per Protocol (PP) Population included participants who: received greater than or equal to (≥) 1 dose of study medication, ≥6 weeks of treatment (unless excluded for allowed reasons), did not severely violate inclusion/exclusion criteria, had tumor assessment, greater than (>) 50% of first 6 weeks of treatment, and were not replaced.|||percentage of participants||95% Confidence Interval|Number
1334989|NCT02013817|Secondary|Percentage of Participants With Adverse Events (AEs)|AEs were recorded from the date of first medication administration until 28 days after the last trial medication.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.|ITT population|||percentage of participants|||Number
1334990|NCT02013817|Secondary|Time to Next Treatment - Time to Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months||||days||Standard Deviation|Mean
1334991|NCT02013817|Secondary|Time to Next Treatment - Percentage of Participants With an Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months||||percentage of participants|||Number
1334992|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1334993|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1334994|NCT02013817|Primary|Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)|Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
1334995|NCT02013791|Other Pre-specified|Change From Baseline in Corneal Staining Score Using a 6-Point Scale|"Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale [Grade 0: <2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: >10 to ≤32 dots, Grade 3: >32 to ≤100 dots, Grade 4: >100 to ≤316 dots and Grade 5: >316 dots or ulcer/erosion (worst)]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement).~Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint."|Baseline (Day 1) to Week 12|Modified Intent-to-treat (mITT) Population included all participant who received study treatment and had Baseline and at least 1 post-baseline assessment. Analyses includes participants who had data at both Baseline and Week 12.|||score on a scale||Standard Deviation|Mean
1334996|NCT02013791|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.|First dose of study drug to up to 24 Weeks|Safety Population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1334997|NCT02013765|Primary|Percentage of Participants Progression Free at 12 and 24 Months||Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
1334998|NCT02013765|Secondary|Percentage of Participants by Best Overall Response to Treatment|Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD).|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS|||percentage of participants|||Number
1334999|NCT02013765|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first study drug treatment to a PFS event.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS|||months||95% Confidence Interval|Median
1335000|NCT02013765|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
1335001|NCT02013765|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to an OS event.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS|||months||95% Confidence Interval|Median
1335002|NCT02013765|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS|||percentage of participants|||Number
1335003|NCT02013765|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS|||percentage of participants|||Number
1335004|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), showing ≥80% reduction of oocysts in Anopheles mosquito gut in ≥50% of the subjects with Study Day 196 sera (one month after the third vaccination) (Study Day 196) in either the 30 μg or 100 μg dose groups.|196 days||||% TRA||95% Confidence Interval|Mean
1335005|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.|84 days||||% TRA||95% Confidence Interval|Mean
1335006|NCT02013687|Secondary|Assessment of Anti-Pfs25 IgG Following the Third Immunization.|Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.|196 days|"In the 30 µg + Alhydrogel group, 15 out of 16 patient samples were analyzed as 1 patient in the group had withdrawn from the study by study day 196. In the 100 µg + Alhydrogel group, 13 out of 16 patient samples were analyzed due to 2 patients in the group withdrawing from the study and an insufficient serum sample from a third patient."|||Antibody Titer||95% Confidence Interval|Geometric Mean
1335007|NCT02013687|Primary|Subjects With Solicited Local Adverse Events||336 days||||Participants|||Count of Participants
1335008|NCT02013687|Primary|Subjects With Solicited Systemic Adverse Events||336 days||||Participants|||Count of Participants
1335009|NCT02013687|Primary|Subjects With at Least One Adverse Event||336 days||||Participants|||Count of Participants
1335010|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. It took 10 to 15 minutes to complete the BIS-11. The BIS-11 was administered at the following visits: Baseline and Week 16/ET.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335016|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||milliseconds||Standard Deviation|Mean
1335267|NCT02008526|Primary|Cost Effectiveness|Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.|up to 36 months|||||||
1335011|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335012|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335013|NCT02013622|Secondary|Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Number of Impulsive Choices||Standard Deviation|Mean
1335014|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores|Delay discounting measures the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ with completion of an Experiential Discounting task (EDT). The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher Probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335015|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335146|NCT02011464|Other Pre-specified|Side Effects of Analgesia|Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain|72 hours post-operative|Number of patients with opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain|||participants|||Number
1335017|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||failures||Standard Deviation|Mean
1335018|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score|The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). The effectiveness domain was rated on a 7-point scale from “extremely satisfied” to “extremely dissatisfied.” The side effects domain provided an option to skip questions 5 to 8 if the subject provided a negative response to item number 4, ie, “As a result of taking this medication, do you currently experience any side effects at all?” Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335019|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI was a self-rated questionnaire that assessed sleep quality and disturbances over a 1-month time interval. Seven domains were measured: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if 1 is available). Only self-rated questions are included in the scoring.The 19 self-rated items are combined to form 7 “component” scores, each of which has a range of 0 - 3 points. In all cases, a score of “0” indicates no difficulty, while a score of “3” indicates severe difficulty. The 7 component scores are then added to yield 1 “global” score, with a range of 0 - 21 points, “0” indicating no difficulty and “21” indicating severe difficulties in all areas.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335020|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score|The SLOF questionnaire used in this trial consists of 30 items grouped into 4 areas: social functioning, social acceptability, activities, and work skill. The SLOF scale correlates with a participant's quality of life. Total SLOF scale is sum of these 4 areas score. Each of the questions in the above domains is rated on a 5-point Likert scale. Scores on the instrument range from 30 to 150 with higher scores indicating the better the overall functioning of the patient.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335021|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score|The PSP was used to measure personal and social functioning in 4 domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the study physician's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees, and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335022|NCT02013622|Secondary|CGI-I Response Rate|The CGI-I response rate was defined as percentage of participants with CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 4, 8, 12, and 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||percentage of participants|||Number
1335023|NCT02013622|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Week 1 to Week 16|All participants who took one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment, the last observation carried forward (LOCF) dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335024|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335025|NCT02013622|Secondary|Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335026|NCT02013622|Primary|Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The observed case (OC) data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335027|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Barratt Impulsiveness Scale 11-Item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335028|NCT02013609|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
1335029|NCT02013609|Secondary|Mean Change From Baseline in Food Delay Discounting Task (DDT)|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
1335147|NCT02011464|Secondary|Post-operative Narcotic Use|Average postoperative narcotics administered in total milligrams of morphine equivalents|72 hours post-operative||||mgs||Standard Deviation|Mean
1335148|NCT02011464|Primary|Subjective Pain|Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.|72 hours post-operative||||units on a scale||Standard Deviation|Mean
1335030|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Delay and Probability Discounting Task (DPDT)|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases.The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
1335031|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||Number of Impulsive Choices||Standard Deviation|Mean
1335032|NCT02013609|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) k Value|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
1335033|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||milliseconds||Standard Deviation|Mean
1335034|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (P-inhibition Failure)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||failures||Standard Deviation|Mean
1335035|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Kellner Symptom Questionnaire (KSQ) Total Score|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23.The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place. A higher score indicates more distress than a lower score.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335171|NCT02010632|Primary|Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)||Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||percent inhibition*hour||Standard Deviation|Mean
1335036|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335037|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Social Adaptation Self-evaluation Scale (SASS) Total Score|The SASS was a self-rated instrument to assess the social motivation and behavior in participants with depression. It contained 21 items covering the different aspects of social interactions, global social attitude, and self-perception. The SASS total score will be un-evaluable if less than 16 of the 20 items (for item number 1 and item number 2, participant is to answer either one of these) are recorded. If 16 to 19 of the 20 items are recorded, the SASS total score will be the mean of the recorded items multiplied by 20 and then rounded to the first decimal place.Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range of 0 to 60 (higher scores, indicating worse outcome).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335038|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) Single Item Sub-scores|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335039|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) 3-item Total/Summed Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335040|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
1335041|NCT02013609|Secondary|Percentage of Participants With MADRS Remission|MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||percentage of participants|||Number
1335042|NCT02013609|Secondary|Percentage of Participants With MADRS Response|MADRS response rate was defined as ≥ 50% reduction in respective total scores from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||percentage of particpants|||Number
1335043|NCT02013609|Secondary|Number of Participants With CGI-I Response|The CGI-I response rate was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 1, 2, 3, 4, 6, 8 ,10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit|||participants|||Number
1335052|NCT02013544|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1335268|NCT02008526|Primary|HIV Sexual Risk Behavior|Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.|9-months post randomization|Participants retained through nine months post randomization.|||# Episodes (Past 30 Days)||Standard Deviation|Mean
1335044|NCT02013609|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 12|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Weeks 1, 2, 3, 4, 5, 6, 8, 10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit|||Units on a scale||Standard Deviation|Mean
1335045|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Total Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
1335046|NCT02013609|Primary|Mean Change From Baseline to Week 12 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). Detailed instructions for administration of this structured interview was provided in the SIGMA. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
1335047|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1335048|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1335049|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1335050|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1335051|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe vaginal dryness at Baseline.|||units on a scale||Standard Error|Mean
1335172|NCT02010567|Secondary|Disease-free Survival (DFS) and Overall Survival (OS) Based on Pathological Complete Response (pCR).|Phase II only - a comparison of DFS and OS for patients who achieve pCR and those who do not. DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause.OS is defined as the time from surgical resection until death|6 years|||||||
1335053|NCT02013544|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1335054|NCT02013544|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of parabasal cells||Standard Error|Mean
1335055|NCT02013544|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of superficial cells||Standard Error|Mean
1335056|NCT02013531|Secondary|Mean Change From Baseline in Barratt Impulsiveness Scale 11-item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. The BIS-11 was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335057|NCT02013531|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335058|NCT02013531|Secondary|Mean Change From Baseline in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335065|NCT02013531|Secondary|Mean Change From Baseline in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42, with higher scores indicative of a worse outcome. The MGH-CPFQ was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335173|NCT02010567|Secondary|Overall Survival (OS)|Phase II only - OS is defined as the time from surgical resection until death|6 years|||||||
1335174|NCT02010567|Secondary|Disease-free Survival (DFS)|Phase II only - DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause.|6 years|||||||
1335059|NCT02013531|Secondary|Mean Change From Baseline to Week 6 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Number of Impulsive Choices||Standard Deviation|Mean
1335060|NCT02013531|Secondary|Mean Change From Baseline in Delay and Probability Discounting Task (DPDT) Scores|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value: value = A / (1 + hO) p is probability of reward and O is odds against. The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335061|NCT02013531|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Score|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
1335062|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for Mean Reaction Time|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||milliseconds||Standard Deviation|Mean
1335063|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for P-inhibition Failures|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||failures||Standard Deviation|Mean
1335064|NCT02013531|Secondary|Mean Change From Baseline in Kellner Symptom Questionnaire (KSQ)|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23. A higher score indicates more distress than a lower score. The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335226|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
1335066|NCT02013531|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335067|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score|The HAM-A was utilized for the evaluation of anxiety symptoms and was administered using the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). Detailed instructions for administration of this structured interview were provided in the SIGH-A. The HAM-A was administered at the following visits: screening, Baseline, Weeks 1, 2, 3, 4, and 6/ET. HAM-A is a 14-item scale with each item is scored on a scale from 0 (not present) to 4 (very severe) with a total score of 0 to 56, with higher scores indicating severe anxiety symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.|||Units on a scale||Standard Error|Least Squares Mean
1335068|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. The HAM-D17 was administered at the following visits: screening, Baseline, and Week 6/ Early termination (ET). HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335069|NCT02013531|Secondary|Percentage of Participants With a MADRS Remission|MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Percentage of participants|||Number
1335070|NCT02013531|Secondary|Percentage of Participants With a MADRS Response|MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome.|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Percentage of participants|||Number
1335071|NCT02013531|Secondary|Percentage of Participants With CGI-I Response Rate|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Week 1 to Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||percentage of participants|||Number
1335072|NCT02013531|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.|The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: “Compared to his/her condition at baseline, how much has the participant changed?” Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
1335175|NCT02010567|Secondary|Number of Participants With Grade 3 or Higher, Treatment-related Toxicities|Toxicity profile of CRLX101 when combined with capecitabine + radiotherapy to treat patients with locally advanced rectal cancer. Phase Ib and Phase II - Safety is the reported adverse event (AE) profile characterized by NCI CTCAE v4.0. The profile was limited to grade 3 or higher, treatment related AEs.|12 weeks||||participants with AE|||Number
1335073|NCT02013531|Secondary|Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.|||Units on a scale||Standard Error|Least Squares Mean
1335074|NCT02013531|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid Baseline and Post-Baseline efficacy assessment. A mixed model repeated measures (MMRM) analysis was performed.|||Units on a scale||Standard Error|Least Squares Mean
1335075|NCT02013388|Primary|Pharmacokinetics: Plasma Cmax Values on Day 14|Plasma Cmax values from Day 14 subjects with repeat administration of N91115|Day 14|All subjects completing plasma collection sampling for N91115|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1335076|NCT02013388|Primary|Pharmacokinetics: Day 1 Plasma Cmax Values|All subjects who completed sample collections for Day 1 plasma N91115|Day 1|All subjects that completed the plasma collection sampling were included in the analysis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1335077|NCT02013388|Primary|Pharmacokinetics: AUCtau Day 14|Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115|Day 14|All patients that completed the required days of dosing to study end|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1335078|NCT02013388|Primary|Pharmacokinetics: Day 1 AUClast|Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration|Day 1|All patients that had plasma samples collected were included in the analysis|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1335079|NCT02013388|Primary|Safety and Tolerability of N91115|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|21 Days|All patients enrolled in the study were evaluated for safety endpoints|||participants|||Number
1335080|NCT02013245|Secondary|Number of Participants With Three-cytokine-positive CD4+ T-cell Response|Measure of the kinetics of CD4+ T-cell responses to MTBVAC or BCG vaccination by tracking the expression of IFNγ, TNFα and IL-2 upon stimulation with live MTBVAC or BCG|Day 28|Number of Participants with Three-cytokine-positive CD4+ T-cell Response (per protocol analysis)|||participants|||Number
1335081|NCT02013245|Primary|Number of Participants With Adverse Events up to 210 Days After Vaccination|"Safety and reactogenicity for all subjects as determined by:~Occurrence of solicited symptoms during the 7-day follow-up period following vaccination and occurrence of unsolicited symptoms during the 210-day follow-up period following vaccination.~Occurrence of grade 3 vaccine related local and general symptoms during the 210-day follow-up period following vaccination and occurrence of serious adverse events throughout the entire study period.~Haematological and biochemical safety test levels prior and after vaccination"|7 months follow up||||participants|||Number
1335082|NCT02013206|Secondary|Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to 2 years|Safety Population included all registered participant who received at least one study treatment and had at least one safety follow-up.|||participants|||Number
1335083|NCT02013206|Secondary|Overall Survival|Overall survival was defined as the time in months from the start of treatment to the date of death irrespective of the cause of death.|Up to 2 years|Safety Population included all participants with at least one study treatment and had at least one safety follow-up. Patients who had not died at the time of the final analysis were censored at the date of last contact.|||months||95% Confidence Interval|Median
1335084|NCT02013206|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was defined as the time in months from the start of treatment until the first date criteria for Progressive Disease (PD) were met (taking as reference the smallest measurements recorded since the treatment started), or the date of death for any reason in the absence of PD. Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.|Up to 2 years|Safety Population included all registered participants who received at least one study treatment and had at least one safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.|||months||95% Confidence Interval|Median
1335100|NCT02013167|Secondary|Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete Remission (CR) was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1,000/μl. CR must have occurred within 12 weeks of the first dose of therapy."|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1335194|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set|||Percentage of participants|||Number
1335195|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||Percentage of participants|||Number
1335085|NCT02013206|Secondary|Time to Progression|Time to progression was defined as the time from start of treatment until the first date criteria for Progressive Disease (PD) was met (taking as reference the smallest measurements recorded since the treatment started). Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Safety Population included all registered patients who received at least 1 dose of study treatment and had at least 1 safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.|||months||95% Confidence Interval|Median
1335086|NCT02013206|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) until the first date Progressive Disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until the date of death. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Participants from the Intent-to-Treat (ITT) Population, that included all participants, with CR or PR. Patients still responding to treatment at the time of analysis were treated as censored observations for duration of response on the date of the last tumour assessment.|||months||95% Confidence Interval|Median
1335087|NCT02013206|Secondary|Disease Control Rate|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Up to 2 years|Intent-to-Treat Population included all registered participants.|||percentage of participants||95% Confidence Interval|Number
1335088|NCT02013206|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST). The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). The patient's best response assignment depended on the achievement of both measurement and confirmation criteria. To be assigned the status of PR or CR, changes in tumour measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met.~CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD."|Up to 2 years|Intent-to-Treat Population included all registered participants.|||percentage of participants||95% Confidence Interval|Number
1335089|NCT02013206|Primary|Non-Progression Rate (NPR) at 8 Weeks|Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 8|Intent-to-Treat Population included all registered participants.|||percentage of participants||95% Confidence Interval|Number
1335090|NCT02013167|Secondary|Time to a 10-point Decrease From Baseline in Global Health Status and Quality of Life or Death|"The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item questionnaire that assesses the health related quality of life of cancer patients. The EORTC QLQ-C30 consists of a global health status/quality of life (QoL) scale, 5 functional scales, 3 symptom scales, and 6 single items.~The global health/QoL scale consists of 2 questions that ask participants to rate their overall health and overall quality of life durig the past week on a scale from 1 (very poor) to 7 (excellent). The scale score was derived as the sum of each score and transformed to a scale from 0 to 100 where higher scores represent a high QoL.~Time to a ≥10-point decrease from baseline GHS/QoL or death, whichever came first, was calculated from baseline. Participants still alive and without a 10-point decrease in GHS/QoL EORTC QLQ-C30 were censored on their last EORTC QLQ-C30 assessment date."|From randomization until the data cut-off date of 04 January 2016; EORTC QLQ-C30 was assessed on day 1, 8, 15, and 29 during cycle 1; days 1, 15, and 29 in cycle 2 and each consolidation cycle, and 30-days following the last dose of drug treatment.|EORTC QLQ-C30 analysis set included all randomized participants with a non-missing baseline and at least 1 non-missing postbaseline result of any EORTC QLQ-C30 scales/item.|||months||95% Confidence Interval|Median
1335091|NCT02013167|Secondary|Number of Participants With Anti-blinatumomab Antibodies|Anti-blinatumomab binding antibodies were evaluated using a validated electrochemiluminescence (ECL)-based assay (binding assay). Samples positive for binding were analyzed using a cell-based bioassay to determine if the detected antibodies had neutralizing properties (neutralizing assay).|Samples were collected on day 29 at the end of cycle 2 and 30 days after the last dose of blinatumomab (median duration of treatment was 70 days).|Participants who received blinatumomab with available post-baseline antibody data.|||participants|||Number
1335092|NCT02013167|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who achieved a best response of CR/CRh*CTi within 12 weeks of treatment initiation, who received an allogeneic HSCT and did not receive any additional anticancer treatment before the transplant. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive."|100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016|Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation and who received an allogeneic HSC without anti-cancer therapy prior to allogeneic HSCT.|||percentage of participants||95% Confidence Interval|Number
1335093|NCT02013167|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.~Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?"|From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.|All participants who received protocol-specified therapy analyzed according to the treatment they received.|||participants|||Number
1335094|NCT02013167|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)||Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1335095|NCT02013167|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation|Bone marrow samples were evaluated for MRD remission by a central laboratory. MRD remission was defined as the occurrence of an MRD level below 10^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry.|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1335096|NCT02013167|Secondary|Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi)|Duration of CR/CRh*/CRi, calculated only for participants who achieved a CR/CRh*/CRi, was calculated from the date a CR/CRh*/CRi was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.|Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group.|Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation.|||months||95% Confidence Interval|Median
1335097|NCT02013167|Secondary|Duration of Complete Remission|Duration of complete remission, calculated only for participants who achieved a CR, was calculated from the date a CR was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.|Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group.|Randomized participants with a best response of complete remission within 12 weeks of treatment initiation.|||months||95% Confidence Interval|Median
1335098|NCT02013167|Secondary|Event Free Survival (EFS)|"Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date.~A relapse event was any one of the following:~Hematological relapse: proportion of blasts in bone marrow >5% or blasts in peripheral blood after documented CR or CRh* or CRi~Progressive disease: An increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells~Extramedullary relapse: extramedullary lesion that is new or increased by 50% from nadir as assessed by Cheson criteria.~The Kaplan-Meier estimate of EFS at 6 months is reported."|6 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1335099|NCT02013167|Secondary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and ANC > 1,000/μl.~Complete Remission with partial hematological recovery (CRh*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Complete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000 (but not both)."|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1335101|NCT02013167|Primary|Overall Survival|Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.|From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group.|All randomized participants|||months||95% Confidence Interval|Median
1335102|NCT02013050|Secondary|"Percent of Patients With RECIST 1.1 Classification of Complete Response"|"The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:~Target Lesion :~Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR~Non-Target Lesion:~Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions"|12 months after end of therapy||||percentage of participants|||Number
1335103|NCT02013050|Secondary|Survival||12 months after end of therapy|Safety Population: all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug that they actually received instead of the drug dose they were randomized. 2 patients were randomized but never received drug and are excluded. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942.|||percentage of participants|||Number
1335104|NCT02013050|Secondary|Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin||4 weeks after end of therapy||||percentage of participants|||Number
1335105|NCT02013050|Secondary|Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin||4 weeks after end of therapy||||days||95% Confidence Interval|Median
1335106|NCT02013050|Secondary|"Percent of Patients With RECIST 1.1 Classification of Complete Response"|"The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:~Target Lesion :~Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR~Non-Target Lesion:~Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions"|4 weeks after end of therapy||||percentage of participants|||Number
1335107|NCT02013050|Secondary|Incidence of Clinically Reported, Non-fungal Infections||4 weeks after end of therapy||||percentage of participants|||Number
1335108|NCT02013050|Secondary|Duration of Severe Oral Mucositis (SOM)|OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.|4 weeks after end of therapy||||WHO score * days||95% Confidence Interval|Median
1335109|NCT02013050|Secondary|Residual Severe Oral Mucositis (SOM)|OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.|4 weeks after end of therapy||||percentage of participants|||Number
1335110|NCT02013050|Primary|Duration of Severe Oral Mucositis (SOM)|Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.|4 weeks after end of therapy||||days||95% Confidence Interval|Median
1335111|NCT02012959|Secondary|Fluid Balance (Intake Minus Output) During Treatment Phase A|Every 6 hours and for the 24-hour daily interval on Days 1 and 2 during Treatment Phase A, fluid balance (milliliters [mL]) was determined by fluid intake (oral and intravenous) minus urine output. Improved fluid balance would be indicated through the induction of increased urine volume. Fluid balance was monitored per institutional guidelines.|Every 6 hours on Days 1 and 2|Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A.|||mL||Standard Deviation|Mean
1335112|NCT02012959|Secondary|Change In Serum Sodium Concentration During Treatment Phase A|Change in serum sodium concentration (mEq/L) from baseline to the end of Day 2 (or 2a) during Treatment Phase A for all participants (responders and non-responders) is reported.|Baseline, Day 2/2a|Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A.|||mEq/L||Standard Deviation|Mean
1335113|NCT02012959|Primary|Change In Serum Sodium Concentration For Responders|Change in serum sodium concentration (mEq/L) for responders from Day 2 (or Day 2a) at the end of Treatment Phase A (where all participants received tolvaptan) to the end of Treatment Phase B for the Early compared to Late Withdrawal groups is reported. Once a participant was randomized to Treatment Phase B, any additional therapies for the purpose of raising serum sodium, including fluid restriction, were considered rescue therapy. Upon receipt of rescue therapy, a participant's endpoint data was collected and then censored from the efficacy analysis thereafter, unless specified.|Day 2/2a, Day 4|Treatment Phase B Responders: full analysis dataset comprised of all participants in the Phase B Safety Sample with both baseline and at least 1 postrandomization serum sodium evaluation in Phase B.|||mEq/L||Standard Deviation|Mean
1335114|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|48 hours after thyroidectomy||||scores on a scale||Full Range|Median
1335115|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|24 hours after thyroidectomy||||scores on a scale||Inter-Quartile Range|Median
1335116|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|6 hours after thyroidectomy||||scores on a scale||Inter-Quartile Range|Median
1335117|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|0.5 hours after thyroidectomy||||scores on a scale||Full Range|Median
1335118|NCT02012582|Primary|Safety and Tolerability of VAS203 in Patients With Moderate and Severe TBI|"Tolerability (good, satisfactory, sufficient, poor) of VAS203 in patients with moderate and severe TBI, as judged by the investigators at day 14.~Safety outcome measure description see safety section"|14 days||||participants|||Number
1335120|NCT02012582|Secondary|Therapy Intensity Level Score|"Therapy Intensity Level Score: Total Score calculated daily as the sum of all individual measures, range from 3 (good outcome) to 50 (worst outcome):~Scores:~0-2 Head elevation 0-8 Sedation 0-1 Paralysis 1-3 Hyperventilation 0-2 Increased Oxygenation 1-3 Cooling 0-2 Osmotherapy 0-3 CSF Drainage 0-1 Red Blood Cell Transfusion 1-3 Cerebral perfusion pressure 0-1 Surgery for mass lesion 0/5/10 none/unilateral/bilateral Decompressive Craniectomy 0/10 Laparatomy to treat intracranial hypertension due to abdominal hypertension"|Daily from day 1 to day 6||||units on a scale||Standard Deviation|Mean
1335121|NCT02012582|Secondary|Duration (Number of Hours) of Cerebral Perfusion Pressure (CPP) < 60 mmHg|Duration (number of hours) of cerebral perfusion pressure (CPP) < 60 mmHg calculated from ICP and mean arterial blood pressure (MAP): CPP = MAP - ICP)|Hourly from start of infusion to 144 hours||||hours||Standard Deviation|Mean
1335122|NCT02012582|Secondary|Duration (Number of Time-points) of Intracranial Pressure (ICP) > 20 mmHg||Hourly from start of infusion to 144 hours||||hours||Standard Deviation|Mean
1335123|NCT02012452|Secondary|Percent Abstinent From Tobacco Use|biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples|end of treatment|If participants did not come the follow-up visit they were assumed to be smokers. If they attended a later follow-up visit, tobacco use was retroactively assessed.|||percent abstinent|||Number
1335124|NCT02012452|Primary|Clinician Administered PTSD Scale|posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)|end of 6 week PTSD treatment||||units on a scale||Standard Deviation|Mean
1335125|NCT02012218|Primary|Mean Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, with 0 being the “best” rating and 6 being the “worst” rating). The MADRS total score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below.|Baseline and Week 6|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid post-baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
1335126|NCT02011893|Secondary|Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation|Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.|||mm||Standard Deviation|Mean
1335127|NCT02011893|Secondary|Percentage of Paresthesia Coverage|Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible.|During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation|There were 73 subjects in whom paresthesia coverage data at both the 12 and 24 week visits were available and included in the analysis. The remaining 23 subjects were excluded due to questionnaire completion errors at the time of data collection.|||Percentage of paresthesia areas||Standard Deviation|Mean
1335128|NCT02011893|Secondary|Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)|Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.|||participants|||Number
1335129|NCT02011893|Primary|Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain|Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.|||mm||Standard Deviation|Mean
1335130|NCT02011542|Secondary|Change in Chronic Fatigue (1-5 Scale) From Baseline|Efficacy of VSL #3 in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 2,4,6,8, weeks|8 weeks|Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.||||||
1335131|NCT02011542|Primary|Improvement in the Bowel Symptom Scale (BSS) From Baseline|Efficacy of VSL #3 in Irritable Bowel Syndrome (IBS) related symptoms in Gulf War illness is measured using BSS at 2, 4, 6, 8 wks|8 weeks|Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.||||||
1335132|NCT02011516|Primary|Urine Drug Screen|Change from positive to negative over the 12 weeks of a medication regimen|study weeks 1-12||||Participants|||Count of Participants
1335269|NCT02008526|Primary|Methamphetamine Use|Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.|9-months post randomization|Number of participants retained through 9-month follow-up.|||Days Used in the Past 30 Days||Standard Deviation|Mean
1335133|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Rate Constant (λz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1335134|NCT02011490|Primary|Geometric Mean Effective Half-life (t1/2eff) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. t½eff was calculated as ln(2)*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Geometric Coefficient of Variation|Geometric Mean
1335135|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Half-life (t1/2) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase, calculated as the natural log of 2 (ln[2])/λz.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Geometric Coefficient of Variation|Geometric Mean
1335136|NCT02011490|Primary|Median Time of the Last Measurable Plasma Concentration (Tlast) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tlast was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Full Range|Median
1335137|NCT02011490|Primary|Median Time to Maximum Observed Plasma Concentration (Tmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tmax was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Full Range|Median
1335138|NCT02011490|Primary|Geometric Mean Apparent Volume of Distribution Estimated at Steady-state (Vss) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state, calculated as CL*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||L||Geometric Coefficient of Variation|Geometric Mean
1335139|NCT02011490|Primary|Geometric Mean of Mean Residence Time (MRT) of Unchanged Drug in the Systemic Circulation Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Geometric Coefficient of Variation|Geometric Mean
1335196|NCT02010255|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttreatment Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.|||Percentage of participants|||Number
1335140|NCT02011490|Primary|Geometric Mean Volume of Distribution During the Terminal Elimination Phase (Vz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vz was calculated as Dose/(AUC0-∞*λz).|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||L||Geometric Coefficient of Variation|Geometric Mean
1335141|NCT02011490|Primary|Geometric Mean Total Clearance (CL) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as Dose/AUC0-∞.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1335142|NCT02011490|Primary|Geometric Mean Percent of AUC0-∞ That Was Extrapolated (AUC%Extrap) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC%extrap represents the percentage of the AUC0-∞ obtained by extrapolation, calculated as (1 - [AUC0-last/AUC0-∞]) multiplied by 100.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||Percent extrapolated||Geometric Coefficient of Variation|Geometric Mean
1335143|NCT02011490|Primary|Geometric Least Squares Mean Maximum Observed Plasma Concentration (Cmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Cmax was determined from the observed plasma concentration-time data. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of Cmax. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||ug/mL||95% Confidence Interval|Least Squares Mean
1335144|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-last was determined by trapezoidal method. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of AUC0-last. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||ug*hr/mL||95% Confidence Interval|Least Squares Mean
1335145|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Drug Concentration-time Curve From Time Zero to Infinity (AUC0-∞) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-∞ was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC0-last, determined by trapezoidal method) and the extrapolated area given by Cest,last/λz, where Cest,last is the estimated concentration corresponding to the time of the last measurable concentration and λz is the apparent first-order terminal elimination rate constant. For each subject, λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the analysis of variance (ANOVA) linear fixed-effect model performed on natural log-transformed values of AUC0-∞. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||ug*hr/mL||95% Confidence Interval|Least Squares Mean
1335568|NCT02004158|Primary|Rate of Exercise Completion|Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.|8 weeks||||Participants|||Number
1335149|NCT02011113|Secondary|Number of Participants With Adverse Events|Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.|From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks|Safety population includes all participants who took at least one dose of study medication.|||participants|||Number
1335150|NCT02011113|Secondary|Kaplan-Meier Estimates of PFS (Later Cut-off Date)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||weeks||95% Confidence Interval|Median
1335151|NCT02011113|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||weeks||95% Confidence Interval|Median
1335152|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||weeks||95% Confidence Interval|Median
1335153|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks|Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed.||||||
1335154|NCT02011113|Secondary|Time to Response (Later Cut-off Date)|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment.|||weeks||Full Range|Median
1335155|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
1335156|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population (EEP) includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
1335157|NCT02011113|Secondary|Time to Response|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks.|Included participants with at least a PR or better based on Assessment using IMWG criteria.|||weeks||Full Range|Median
1335158|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
1335159|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
1335160|NCT02010996|Primary|Early Complications of Vascular Zone||2 weeks||||participants|||Number
1335161|NCT02010684|Secondary|Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months|The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1335162|NCT02010684|Secondary|Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months|The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1335163|NCT02010684|Secondary|Change From Baseline in EQ-5D at 6 Months|"The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.~The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale."|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1335164|NCT02010684|Secondary|Change From Baseline in Low Density Lipoprotein-C at 6 Months||Baseline and 6 months||||mg/dL||Standard Deviation|Mean
1335165|NCT02010684|Secondary|Change From Baseline in Blood Pressure at 6 Months||Baseline and 6 months||||mm Hg||Standard Deviation|Mean
1335166|NCT02010684|Primary|Change From Baseline in Depression Measures at 6 Months|"The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.~The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression."|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1335167|NCT02010684|Primary|Change From Baseline in Hemoglobin A1c at 6 Months|Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.|Baseline and 6 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
1335168|NCT02010632|Secondary|Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||||||
1335169|NCT02010632|Secondary|Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||||||
1335170|NCT02010632|Secondary|Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||||||
1335176|NCT02010567|Secondary|Pathological Response Rate|"Pathologic response will be made based on microscopic assessment of the surgical specimen at the primary treatment site, including regional nodes and any peritumoral satellite nodules in the specimen, and categorized as outlined below as per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 7th edition.Determination of pathological response will be reported by the local pathologist.~Pathologic Complete Response (pCR): No gross or microscopic tumor identified anywhere within the surgical specimen. This must include: No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor.~Moderate response: Single cells or small groups of cancer cells~Minimal response: Residual cancer outgrown by fibrosis~Poor response:Minimal or no tumor kill; extensive residual cancer"|12 weeks||||Participants|||Count of Participants
1335177|NCT02010567|Primary|Pathological Complete Response (pCR) Rate|Primary Objective Phase II: Pathological response will be made based on microscopic assessment of the surgical specimen at the primary treatment site. A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include:No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor.|12 weeks||||percentage of participants with pCR||95% Confidence Interval|Number
1335178|NCT02010567|Primary|Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer|The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) >3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting >48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiring dose reduction; Any other non-hematologic toxicity G ≥3 requiring a dose reduction (G ≥3 infusion-related reactions were not a DLT unless they recur despite slowing down the infusion); Other CRLX101 related treatment emergent adverse effect (TEAE) that requires patient withdrawal prior to completing all doses; Radiotherapy interruption due to TEAEs ≥5 days; or Dose interruption or reduction of capecitabine due to TEAE that results in <50% of the scheduled capecitabine dose for entire course|12 weeks|Since this objective applies only to Phase Ib patients, the Phase II cohort patients were not included|||mg/m^2 every other week|||Number
1335179|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
1335180|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
1335181|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335182|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335183|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335184|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335185|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335186|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335187|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||Percentage of participants|||Number
1335188|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||Percentage of participants|||Number
1335189|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||Percentage of participants|||Number
1335190|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
1335191|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
1335192|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
1335193|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
1335197|NCT02010255|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.|||Percentage of participants|||Number
1335198|NCT02010255|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A and 1 participant in Cohort B who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.|||Percentage of participants|||Number
1335199|NCT02010255|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.|||Percentage of participants|||Number
1335200|NCT02010255|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.|||Percentage of participants|||Number
1335201|NCT02010255|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.|||percentage of participants|||Number
1335202|NCT02010255|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1335203|NCT02010255|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.|||percentage of participants|||Number
1335204|NCT02010216|Primary|Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|12 weeks|Safety population included all participants who received study drug.|||participants|||Number
1335205|NCT02010216|Primary|Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved|American College of Rheumatology (ACR) ACR20, ACR50 or ACR70 response is defined as a ≥ 20% or 50% or 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 12|Intent-to-treat population included all participants.|||percentage of participants|||Number
1335206|NCT02010216|Primary|Change From Baseline in Disease Activity 28 (DAS28) Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 12|Intent-to-treat population included all participants.|||score on a scale||Standard Deviation|Mean
1335207|NCT02009982|Secondary|Incidence of Serious Adverse Events|The secondary endpoint for this study will be the incidence of serious adverse events related to the study procedure within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.||||||
1335208|NCT02009982|Primary|Syncope Recurrence Rate|The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.||||||
1335220|NCT02009865|Secondary|Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 3rd. and 4th secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
1335221|NCT02009865|Secondary|Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL|This first secondary endpoint in subjects with at least 1 qualifying triglyceride >885 mg/dL was tested in parallel together with the primary endpoint, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
1335209|NCT02009878|Secondary|Change From Baseline in Cumulative Urine Volume at 0-6 Hours, 0-12 Hours and 0-24 Hours.|Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4, to 6, 6, to 8, 8, to 12, and 12 to 24 hours relative to Day 1 dosing time. Urine was collected on Day 1 at intervals of 0 to 2,2 to 4, 4 to 6, 6 to 8, 8 to 12, and 12 to 24 hours postdose. For the start of the urine collection on Day 0, a window of 15 to 40 minutes prior to the assigned dosing time was acceptable, with the 0 to 24 hour collection period on Day 1 starting 24 hours after the start time on Day 0. Participants were asked to void immediately prior to the end of the collection interval. The volume of individual voids were measured and recorded prior to refrigerating. All voids in a collection interval were pooled at the end of the collection interval, at which time the volume was determined, recorded and an aliquot taken for osmolality, sodium, potassium, and creatinine assessments.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mL||Standard Deviation|Mean
1335210|NCT02009878|Secondary|Change From Baseline in Fluid Balance (Fluid Intake Minus Urine Output) From 0-6 Hours, 0-12 Hours and 0-24 Hours.|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12 hours, and 12 to 24 hours relative to the Day 1 dosing time. Fluid balance was determined as fluid intake minus urine output.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mL||Standard Deviation|Mean
1335211|NCT02009878|Secondary|Change From Baseline in Fluid Intake From 0-6 Hours, 0-12 Hours and 0-24 Hours|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mL||Standard Deviation|Mean
1335212|NCT02009878|Primary|Time of Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Time of maximal increase in serum sodium is summarized in the table below by tolvaptan dose. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||hours||Full Range|Median
1335213|NCT02009878|Secondary|Change From Baseline in Serum Sodium Concentrations|Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mmol/L||Standard Deviation|Mean
1335214|NCT02009878|Secondary|AUC Infinity (Area Under the Concentration-time Curve From Time Zero to Infinity) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. If an indwelling catheter was utilized, saline flushes were used. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.|||ng·h/mL||Standard Deviation|Mean
1335215|NCT02009878|Secondary|Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.|||hours||Full Range|Median
1335216|NCT02009878|Secondary|Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.|||ng/mL||Standard Deviation|Mean
1335217|NCT02009878|Primary|Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Maximal increase in serum sodium is summarized below by tolvaptan dose. Blood samples for determination of plasma concentrations of tolvaptan were collected predose and at 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose on Day 1 or at Early Termination (ET).|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mmol/L||Standard Deviation|Mean
1335218|NCT02009865|Secondary|Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6)|This secondary endpoint in subjects with Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6), together with the 2nd. and 3rd.secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
1335219|NCT02009865|Secondary|Percent Change in High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 2nd. and 4th. secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
1335222|NCT02009865|Primary|Percent Change in Triglyceride for All Subjects|This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|Full Analysis Set (FAS)|||Percentage of change (%)||Inter-Quartile Range|Median
1335227|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
1335228|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
1335229|NCT02009722|Secondary|Side Effects: Sedation|Patients will be evaluated by a member of the study team at 6, 12, and 24 hours after spinal administration. The presence of sedation will be graded by the Richmond Agitation Sedation Scale. Patients with a score of (-)2 or lower on the Richmond were classified as being positive for sedation.|6, 12, and 24 hours after spinal administration||||participants|||Number
1335230|NCT02009722|Secondary|Side Effects: Nausea|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. Patients with moderate or severe nausea will be recorded.|6 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
1335231|NCT02009722|Secondary|Side Effects: Pruritus|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|6 hours after spinal administration|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
1335232|NCT02009722|Primary|Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients|Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score <4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients|12 hours after administration of spinal anesthesia|The primary outcome was determining the optimal dose of IT morphine and IT hydromorphone for patients undergoing cesarean delivery. Study was designed to determine the ED90 (effective dose in 90% patients; effective dose meaning a VAS score for pain of 3 or less at 12 hours after spinal placement).|||micrograms|||Number
1335233|NCT02009696|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1335234|NCT02009696|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1335235|NCT02009696|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1335236|NCT02009696|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1335237|NCT02009696|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
1335238|NCT02009163|Secondary|Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up|The ACSA was used in this study to assess potential withdrawal symptoms associated with chronic use of SPD489. The ACSA is a self-completed scale used to assess withdrawal symptoms. The scale has 16 symptom items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The ACSA total score ranges from 0-64, where a higher score indicates greater withdrawal symptom severity.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose)|The RSAS. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Visits 21 and 22 could include participants who discontinued but completed a final safety and efficacy assessment. Not all participants had data for this outcome.|||units on a scale||Standard Deviation|Mean
1335245|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
1336120|NCT01994486|Other Pre-specified|Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose|Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment|4/22/2014-5/6/2014||||participants|||Number
1335239|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Randomized Safety Analysis Set (RSAS), defined as participants in the SAS who were randomized and took at least 1 dose of investigational product in the randomized-withdrawal period. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Three participants had no data for this outcome.|||participants|||Number
1335240|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 8 (12 weeks after start of open-label treatment [Week 12])|The OSP. Three participants in the OSP did not have data collected for this outcome. Visit 8 included only participants who completed open-label treatment.|||participants|||Number
1335241|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
1335242|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
1335243|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
1335244|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
1335357|NCT02007200|Secondary|The Number of Participants Alive Without Relapse at Last Follow-up|Relapse-free survival will be determined at the last follow-up visit.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.|||participants|||Number
1335246|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
1335247|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
1335248|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
1335249|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5­-Dimension 5­-Level Self­-Report Questionnaire (EQ­-5D­-5L) For Mobility at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
1335250|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
1335251|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period|The Y-BOCS-BE measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. The scale is a clinician rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The scale includes questions regarding the amount of time spent on obsessions, impairment or distress experienced, and resistance and control over these thoughts. The same types of questions were asked about compulsions (ie, time spent, interference, etc.).Total scores range from 0 to 40. A total score of 0-7 is sub-clinical, 8-15 is mild, 16-23 is moderate, 24-31 is severe, and 32-40 is extreme. A decrease from baseline in Y-BOCS-BE Total Score represents an improvement in obsession with binge-eating thoughts or compulsiveness of binge-eating behaviors.|Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=54; SPD489: n=107).|||units on a scale||Standard Error|Least Squares Mean
1335262|NCT02008617|Secondary|Quality of Recovery (QoR15)|Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = “none of the time” to 10 = “all of the time”; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported.|24hrs||||units on a scale||Inter-Quartile Range|Median
1335263|NCT02008617|Secondary|Patient Satisfaction|Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).|24hr||||units on a scale||Inter-Quartile Range|Median
1335252|NCT02009163|Secondary|Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period|The CGI-S permits a global evaluation of a subject’s condition and severity of symptoms. The CGI-S was performed to rate the severity of a subject’s condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
1335253|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Number of Binge­ Eating Days Per Week During The Randomized-withdrawal Period|A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomized ­withdrawal-baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8).|Randomized­-withdrawal baseline (Visit 8; 12 weeks after start of open­ label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=50; SPD489: n=102).|||days||Standard Error|Least Squares Mean
1335254|NCT02009163|Primary|Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period|Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse – date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject’s condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Full Analysis Set (FAS): participants in the Randomized Safety Analysis Set (RSAS) with at least 1 post-randomization CGI-S assessment. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||days||Inter-Quartile Range|Median
1335255|NCT02008942|Primary|Time to 99% Inhibition of Serum Thromboxane|Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|11 days|Pharmacodynamic (PD) Evaluable Population - patients in the intent-to-treat population who received a full treatment regimen for each of 2 study drugs, had all scheduled PD blood draws, and had no other major protocol violations.|||hours||Standard Deviation|Mean
1335256|NCT02008682|Secondary|Number of Confirmed Hypoglycaemic Episodes|confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L|Weeks 0-26|Safety analysis set included all subjects receiving at least one dose of investigational product.|||episodes|||Number
1335257|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||percentage of subjects|||Number
1335258|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||percentage of subjects|||Number
1335259|NCT02008682|Secondary|Change From Baseline in 7-point Self-measured Plasma Glucose Profile|Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||mmol/L||Standard Deviation|Mean
1335260|NCT02008682|Secondary|Change From Baseline in Fasting Plasma Glucose|Mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||mmol/L||Standard Deviation|Mean
1335261|NCT02008682|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1335270|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Sore Mouth|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335271|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335272|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335273|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Chest|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335274|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335275|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Hemoptysis|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335276|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Dyspnea|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335277|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Dysphagia|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335278|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Coughing|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335279|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Alopecia|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335280|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: Symptom Subscale|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335297|NCT02008227|Primary|Overall Survival (OS): PP-ITT|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.25 years)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
1335323|NCT02007512|Secondary|Concentration Versus Time Summary of Enzalutamide|Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.|Predose on Day 29, 57 and 113|Pharmacokinetic (PK) population for enzalutamide included all participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for enzalutamide or its active metabolite (N-desmethyl enzalutamide).|||microgram per milliliter||Standard Deviation|Mean
1335281|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: GHS Scale|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335282|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: Functional Subscales|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335283|NCT02008227|Secondary|EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items|EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
1335284|NCT02008227|Secondary|Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)|TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
1335285|NCT02008227|Secondary|Minimum Observed Serum Atezolizumab Concentration (Cmin)||Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)|PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||mcg/mL||Standard Deviation|Mean
1335286|NCT02008227|Secondary|Maximum Observed Serum Atezolizumab Concentration (Cmax)||Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)|Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1335287|NCT02008227|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab||Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])|ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.|||Percentage of Participants|||Number
1335312|NCT02007577|Primary|Quantification of Insulin Action With the Insulin Suppression Test (IST)|Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group|after treatment for one month||||mmol/L||95% Confidence Interval|Median
1335288|NCT02008227|Secondary|DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.|From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP|||Months||95% Confidence Interval|Median
1335289|NCT02008227|Secondary|Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT|DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.|From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
1335290|NCT02008227|Secondary|Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP|||Percentage of Participants||95% Confidence Interval|Number
1335291|NCT02008227|Secondary|Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT|Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.|||Percentage of Participants||95% Confidence Interval|Number
1335292|NCT02008227|Secondary|PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP|||Months||95% Confidence Interval|Median
1335293|NCT02008227|Secondary|Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT|PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
1335294|NCT02008227|Secondary|Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP|PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or Death (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup of PP|||Percentage of Participants|||Number
1335295|NCT02008227|Secondary|Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT|PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.|Baseline up to PD or Death (up to approximately 2.25 years)|The PP-ITT analysis set|||Percentage of Participants|||Number
1335296|NCT02008227|Primary|OS: TC1/2/3 or IC1/2/3 Subgroup of PP|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup of PP|||Months||95% Confidence Interval|Median
1335298|NCT02008227|Primary|Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP|Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.|Baseline until death due to any cause (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.|||Percentage of Participants|||Number
1335299|NCT02008227|Primary|Percentage of Participants Who Died: PP-ITT||Baseline until death due to any cause (up to approximately 2.25 years)|PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.|||Percentage of Participants|||Number
1335300|NCT02007954|Other Pre-specified|Exploratory Endpoint - Tmax of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE|Time taken to reach maximum concentration (Tmax) of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..|24 hours||||minutes||Standard Deviation|Mean
1335301|NCT02007954|Other Pre-specified|Exploratory Endpoint - Total Drug Exposure Over Time (AUC) of Doxorubicin and Doxorubicinol Post TACE|Total drug exposure over time (AUC) of doxorubicin and its metabolite doxorubicinol post DEBDOX in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..|24 hours||||ng*h/mL||Standard Deviation|Mean
1335302|NCT02007954|Other Pre-specified|Exploratory Endpoint - Pharmacokinetic (PK) Profile of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE|"PK analysis of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax).~Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin."|24 hours||||ng/mL||Standard Deviation|Mean
1335303|NCT02007954|Secondary|AFP Tumor Marker Pre- and Post-treatment|The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure.|1 month|23 out of 24 patients analyzed due to one patient not completing AFP post-TACE.|||ng/mL||Full Range|Mean
1335304|NCT02007954|Secondary|Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions|The number of patients who underwent a liver transplantation following treatment on this protocol.|6 months||||Participants|||Count of Participants
1335305|NCT02007954|Secondary|Efficacy - Tumor Response by mRECIST|"Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments.~Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD."|1 month||||Participants|||Count of Participants
1335306|NCT02007954|Secondary|Efficacy - Tumor Response by qEASL|"Efficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments.~Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions.~Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions.~Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease.~Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions."|1 month||||Participants|||Count of Participants
1335307|NCT02007954|Secondary|Efficacy - Tumor Response by EASL|"Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments.~Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference.~Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1.~Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1.~Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1."|1 month||||Participants|||Count of Participants
1335308|NCT02007954|Primary|Collection of Adverse Events Related to Study Device as a Measure of Safety|For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE.|1 month|30-day toxicity report of device-related adverse events for all 24 patients with classification and grading based on CTCAE v4.0.|||Adverse Events|||Number
1335309|NCT02007954|Primary|Success of DEBDOX-M1 Procedure as a Measure of Feasibility|Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.|6 months|The 24 patients received a total of 50 DEBDOX-M1 TACE procedures.|||percentage of successful treatments|DEBDOX-M1 treatments||Number
1335310|NCT02007863|Primary|Number of Successful Unrelated Cord Blood (UCB) Transplants|The number of patients who received successful UCB transplants as evidenced by absolute neutrophil recovery.|2 Years|THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.Unrelated Cord Blood (UCB) transplant|||participants|||Number
1335311|NCT02007577|Secondary|Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT)|compare changes in insulin clearance as assessed by the GGIT before and after treatment with salsalate to placebo|one month on treatment||||pmol/min x 4h||95% Confidence Interval|Median
1335313|NCT02007512|Primary|Progression Free Survival (PFS): Diagnostic Positive (DX+) Population|PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.|From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|Dx+ population: Subset of ITT population, defined prior to the first unblinded analysis as meeting the threshold for diagnostic score based on ribonucleic acid (RNA) sequencing data from tumor tissue.|||months||95% Confidence Interval|Median
1335314|NCT02007512|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory tests included hematology (hematocrit, hemoglobin, platelet count, red blood cell count, total neutrophils [absolute] and white blood cell count with differential) and serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase [ALT], aspartate transaminase [AST], blood urea nitrogen and creatinine, calcium, sodium, potassium, chloride, glucose (non-fasting), lactate dehydrogenase, magnesium, phosphorus/phosphate, total bilirubin, total bicarbonate, total protein and uric acid). Clinically significant abnormality evaluation was based on clinical investigator’s judgment.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
1335315|NCT02007512|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities: Systolic blood pressure (SBP): absolute SBP <90 millimeters of mercury (mmHg) and decrease from baseline (DFB) >30 mmHg, absolute SBP>180 mmHg and increase from baseline (IFB) >40 mmHg, final visit or 2 consecutive visits SBP >=20 mmHg change from baseline (CFB), most extreme post-baseline SBP >=140 mmHg, most extreme post-baseline SBP >=180 mmHg, most extreme SBP >=140 mmHg and >=20 mmHg CFB, most extreme SBP >=180 mmHg and >=20 mmHg CFB; diastolic blood pressure (DBP): absolute DBP > 105 mmHg and IFB >30 mmHg, absolute DBP <50 mmHg and DFB >20 mmHg, final visit or 2 consecutive visits DBP >=15 mmHg CFB, most extreme post-baseline DBP >=90 mmHg, most extreme post-baseline DBP >=105 mmHg, most extreme DBP >=90 mmHg and >=15 mmHg CFB, most extreme DBP >=105 mmHg and >=15 mmHg CFB; heart rate <50 beats per minute (BPM) and DFB >20 BPM or heart rate >120 BPM and IFB >30 BPM.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
1335316|NCT02007512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only the participants with treatment-emergent AEs of grade 3 (severe) or higher grade were reported in this outcome measure.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
1335317|NCT02007512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
1335318|NCT02007512|Other Pre-specified|Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC)||Day 1, 29, 57, 113 and 169|Protocol of this study was amended and data for this outcome measure was not analyzed as per planned analysis.||||||
1335319|NCT02007512|Other Pre-specified|European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23)||Month 24|||||||
1335320|NCT02007512|Other Pre-specified|European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30)||Month 24|||||||
1335321|NCT02007512|Secondary|Concentration Versus Time Summary of N-desmethyl Enzalutamide|N-desmethyl enzalutamide was the active metabolite of enzalutamide. Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.|Predose on Day 29, 57 and 113|PK population for N-desmethyl enzalutamide included all the participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for N-desmethyl enzalutamide.|||microgram per milliliter||Standard Deviation|Mean
1335322|NCT02007512|Secondary|Concentration Versus Time Summary of Exemestane|Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.|Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169|PK population for exemestane was defined as all participants in the safety population who received any amount of exemestane and had at least 1 reportable plasma concentration value for exemestane.|||Picogram per milliliter||Standard Deviation|Mean
1335343|NCT02007369|Primary|Self Reported Relapse Rate at 6 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 6 months.|6-months||||participants|||Number
1335324|NCT02007512|Secondary|Progression Free Survival (PFS) at 6 Months|PFS at 6 months was defined as the percentage of participants with no event of disease progression at Month 6 landmark, estimated by Kaplan-Meier methods. PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. The analysis of PFS was based on investigator assessment of disease progression.|Month 6|ITT population included all the participants randomly assigned to double-blind study treatment.|||percentage of participants||95% Confidence Interval|Number
1335325|NCT02007512|Secondary|Time to Progression|Time to progression was defined as the time from the date of randomization to PD defined by the investigator using RECIST 1.1. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who did not experience disease progression, time to progression was right censored at the date of the last tumor assessment prior to data cutoff or date of new antitumor treatment, whichever occurred first.|From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment.|||months||95% Confidence Interval|Median
1335326|NCT02007512|Secondary|Time to Response|Time to response: Time from randomization to first documentation of CR or PR. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who were not known to have had a CR or PR were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.|From randomization until first documentation of CR or PR, or last tumor assessment without PD or death prior to new antitumor treatment initiation, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1335327|NCT02007512|Secondary|Duration of Objective Response|Duration of objective response: Time from first documentation of CR or PR, to the first documentation of PD or death due to any cause, whichever occurred first as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants with no PD or death (after initial CR or PR) at the analysis date were censored at last tumor assessment date prior to date of new antitumor treatment or data cutoff.|From first documentation of CR or PR until PD, or last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1335328|NCT02007512|Secondary|Best Objective Response Rate|Best objective response rate: Percentage of participants with measurable disease and with a best response of CR or PR according to RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: Atleast 30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. Response evaluation was based on investigators' judgment.|From randomization until CR or PR, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants with measurable response.|||percentage of participants||95% Confidence Interval|Number
1335329|NCT02007512|Secondary|Clinical Benefit Rate-24 (CBR-24)|CBR-24: Percentage of participants with a best response of complete response (CR), partial response (PR), or stable disease (SD) sustained for atleast 24 weeks, as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during study as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions.|From randomization up to 3 years|ITT population included all the participants randomly assigned to double-blind study treatment.|||percentage of participants||95% Confidence Interval|Number
1335344|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 2 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 2 months.|2 months||||participants|||Number
1335345|NCT02007369|Primary|Self Reported Relapse Rate at 2 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 2 months.|2 months after joining the groups for the social networking services.||||participants|||Number
1335330|NCT02007512|Primary|Progression Free Survival (PFS): Intent-to-Treat (ITT) Population|PFS was defined as the time in months from randomization to the first documentation of progression of disease (PD) or death on study due to any cause, whichever occurred first. PD according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) was defined as greater than or equal to (>=) 20 percent (%) increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.|From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment.|||months||95% Confidence Interval|Median
1335331|NCT02007434|Secondary|Patient Experience Questions|"Participants were asked to complete 3 patient experience questions, each answered as Yes or No:~Given your experience in this study:~Would you recommend this procedure to a friend?~Would you agree to receive additional treatments?~Has the treatment you received in this study affected your normal activities?~The percentage of participants answering Yes on each question is reported."|Day 84|Safety analysis set with available data at each time point|||percentage of participants|||Number
1335332|NCT02007434|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and Day 84|Safety analysis set with available data at both time points|||mm||Standard Deviation|Mean
1335333|NCT02007434|Secondary|Change From Baseline in Submental Skin Laxity Grades (SMSLG)|Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
1335334|NCT02007434|Secondary|Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
1335335|NCT02007434|Secondary|Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
1335336|NCT02007434|Secondary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at each time point.|||units on a scale||Standard Deviation|Mean
1335337|NCT02007434|Primary|Induration Grading Scale Scores|"The following grading system was used for the assessment of induration:~Induration absent to minimal (0)~Induration associated with at least approximately 30% of the treatment area (1)~Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)~Induration covering the entire treatment area but contained within the treatment area (3)~Induration of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data|||units on a scale||Standard Deviation|Mean
1335338|NCT02007434|Primary|Bruising Grading Scale Scores|"The following grading system was used for the assessment of bruising:~Bruising absent (0)~Bruising associated with 1 to 3 needle insertion points (1)~Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)~Bruising covering the entire treatment area but contained within the treatment area (3)~Bruising of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data|||units on a scale||Standard Deviation|Mean
1335339|NCT02007434|Primary|Swelling Grading Scale Scores|"The following grading system was used for the assessment of swelling:~Swelling/edema absent (0)~Minimal swelling/edema contained within treatment area (1)~Modest swelling/edema contained within treatment area (2)~Substantial swelling/edema contained within treatment area (3)~Swelling/edema of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data|||units on a scale||Standard Deviation|Mean
1335340|NCT02007434|Primary|Change From Baseline in Pain Assessment Using McGill Pain Questionnaire|Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).|Baseline (predose) and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
1335341|NCT02007434|Primary|Change From Baseline in Pain Visual Analog Scale Scores|Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Full Range|Median
1335342|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 6 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 6 months.|6 months||||participants|||Number
1335346|NCT02007291|Secondary|Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease|Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in AD. The secondary domain examined was independence for daily activities and the evaluation tools used was the brazilian version of the Pfeffer Functional Activities Questionnaire (PFAQ). PFAQ scale range from 0 to 30 points and the greater value is associated with a greater dependence in daily activities.|three months||||units on a scale||Standard Deviation|Mean
1335347|NCT02007291|Primary|Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease|Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in Alzheimer's Disease. The main domain examined and the evaluation tools was cognition and Mini-Mental State Examination- MMSE, respectively. MMSE scores range from 0 to 30, while the greater value is associated with a better cognition state. An increase of 2 or more points in MMSE was considered as response.|three months||||units on a scale||Standard Deviation|Mean
1335348|NCT02007278|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death||12 weeks|All the randomized patients.|||Patients|||Number
1335349|NCT02007278|Secondary|Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment|MAGE , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement. In this endpoint, mean MAGE value is reported for hypo glycemic patients.|12 weeks|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison and had at least one hypoglycemia event.|||mg/dL||Standard Deviation|Mean
1335350|NCT02007278|Secondary|Number of Patients With Incidence of Hypoglycemia|Hypoglycemia defined as Glycemia < 70 mg/dl|12 weeks|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||Patients|||Number
1335351|NCT02007278|Secondary|Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline||baseline, 12 weeks of treatment|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1335352|NCT02007278|Secondary|Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12||Screening visit , 12 weeks of treatment|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data|||percentage of patients|||Number
1335353|NCT02007278|Secondary|Glycemic Variability Measured by Total Standard Deviation (TSD)|"Total standard deviation (TSD) or standard deviation of all values of a given measurement period, which has the advantage of being able to include all measured values on a given time period (even several days) through a common and simple statistical concept.~TSD is calculated conventionally with the formula σ = √Σ (Xi - ῦ) 2 / N (where Xi represents each of the values, ῦ represents the population mean and N is the number of observations) from the data of continuous monitoring of tissue glucose obtained during the measurement."|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||mg/dL||Standard Deviation|Mean
1335354|NCT02007278|Secondary|Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)|"Continuous Overlapping Net Glycemic Action (CONGA) which assesses intra-day glycemic variability by calculating the difference between values at different intervals, adjusted according to requirements with the advantage of being highly reproducible.~CONGA is calculated in the conventional way with the formula √tқΣt = t1 (Dt -Ď2) / қ - 1, Ď = tқ Σ Dt t = t1 / қ, Dt = Gt-Gt-m (where қ = Observations with an observation n x 60 minutes, G = glucose measure) from the data of continuous monitoring of tissue glucose obtained during the measurement period."|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||mg/dL||Standard Deviation|Mean
1335355|NCT02007278|Primary|Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)|Mean Amplitude of Glycemic Excursions (MAGE) , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement.|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||mg/dL||Standard Deviation|Mean
1335356|NCT02007252|Primary|Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year|Size of the AAA was determined using an abdominal ultrasound technique at baseline, 3 months, and 12 months after treatment with study drug. Growth rate (in mm/year) was calculated from the change in AAA size compared to baseline|month 3, month 12|The pharmacodynamic analysis set, which included randomized participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at each time point were analyzed.|||millimeter/year||90% Confidence Interval|Least Squares Mean
1335359|NCT02007200|Primary|Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF|Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.|Up to 12 months|We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.||||||
1335360|NCT02007200|Primary|Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone|The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.|From baseline to surgery, up to 42 days|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.|||Percent change||Full Range|Mean
1335361|NCT02007096|Secondary|Pain Score|"Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being no pain and 10 being the most pain you have ever experienced."|24 hours postoperatively||||units on a scale||Standard Deviation|Mean
1335362|NCT02007096|Secondary|Operating Procedure Time|Total number of minutes for the procedure, not including anesthesia time.|Procedure begin time to procedure end time||||min||Standard Deviation|Mean
1335363|NCT02007096|Secondary|Pain Score|"Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being no pain and 10 being the most pain you have ever experienced."|1 hour postoperatively||||units on a scale||Standard Deviation|Mean
1335364|NCT02007096|Primary|Post-operative Opioid Use|Amount of opioids used by patients at certain time points.|up to 24 hours||||mg||Standard Deviation|Mean
1335365|NCT02007070|Secondary|DOR Per irRC in PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all PD-L1 positive participants who experienced an irCR or irPR.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
1335366|NCT02007070|Secondary|PFS Per irRC in PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all PD-L1 positive participants.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1335367|NCT02007070|Secondary|ORR Per irRC in PD-L1 Positive Participants|ORR per irRC was defined as the percentage of participants in the analysis population who had a irCR (Complete disappearance of all tumor lesions [whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented]) or irPR (Decrease in sum of the products of the two largest perpendicular diameters [SPD] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of PD-L1 positive participants who experienced an irCR or irPR is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1335368|NCT02007070|Secondary|OS in PD-L1 Positive Participants|OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all PD-L1 positive participants in months.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1335369|NCT02007070|Secondary|DOR by RECIST 1.1 in PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all PD-L1 positive participants with a confirmed response is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
1335395|NCT02006719|Secondary|Investigator Assessment of Improvement With Treatment at Day 95|Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 10 participants also excluded for incomplete questionnaire|||participants|||Number
1335370|NCT02007070|Secondary|PFS by RECIST 1.1 in PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists’ review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all PD-L1 positive participants is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1335371|NCT02007070|Secondary|ORR Per RECIST 1.1 in PD-L1 Positive Participants|On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of PD-L1 positive participants who experienced a CR or PR is presented.|Up to 2 years|The FAS population for this outcome measure consisted of all participants who were classified as PD-L1 positive, received at least one dose of study drug and had Baseline data for the analyses that required Baseline data.|||Percentage of Participants||95% Confidence Interval|Number
1335372|NCT02007070|Secondary|DOR Per irRC in Strongly PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all strongly PD-L1 positive participants who experienced an irCR or irPR.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
1335373|NCT02007070|Secondary|PFS Per irRC in Strongly PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all strongly PD-L1 positive participants.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1335374|NCT02007070|Secondary|ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants|ORR per irRC was defined as the percentage of participants in the analysis population who had a Complete Response (irCR: Complete disappearance of all tumor lesions [whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented]) or Partial Response (irPR: Decrease in sum of the products of the two largest perpendicular diameters [SPD] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of strongly PD-L1 positive participants who experienced an irCR or irPR is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1335375|NCT02007070|Secondary|Overall Survival (OS) in Strongly PD-L1 Positive Participants|OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all strongly PD-L1 positive participants in months|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1335376|NCT02007070|Secondary|Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all strongly PD-L1 positive participants with a confirmed response is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
1335377|NCT02007070|Secondary|Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists’ review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all strongly PD-L1 positive participants is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1335396|NCT02006719|Secondary|Subject Satisfaction With Treatment at Day 95|Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.|Day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 11 participants not completing questionnaire also excluded|||participants|||Number
1335378|NCT02007070|Primary|Number of Participants Discontinuing Study Drug Due to AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1335379|NCT02007070|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days for AE monitoring (serious AEs were monitored for up to 90 days after last dose of study drug). The number of participants who experienced an AE is presented.|Up to 27 months (Up to 90 days after last dose of study drug)|The All Treated Set (ATS) population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1335380|NCT02007070|Primary|Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants|On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.|Up to 2 years|The Full Analysis Set (FAS) population consisted of all participants who were classified as strongly PD-L1 positive, received at least one dose of study drug and had Baseline data for the analyses that required Baseline data.|||Percentage of Participants||95% Confidence Interval|Number
1335381|NCT02006888|Primary|Number of Participants With Anterior Chamber Cell Clearing|The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).|Day 8||||Participants|||Count of Participants
1335382|NCT02006836|Primary|AUCs With/Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. Capillary blood samples were detected before and after meals, 10pm, and 3am. Mean of each time point(before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner,10pm, and 3am ) of blood glucose concentrations on 4th to 6th day（without pomelo） were calculated and so as each time point of blood glucose concentrations on 7th to 9th day (with pomelo). Areas under the curves (AUC) of mean blood glucose concentrations of each time point were obtained with/without pomelo.|9 days||||mmol*hour/L||Standard Deviation|Mean
1335383|NCT02006836|Primary|∆g of Dinner With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after dinner were obtained and analyzed.~g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner without pomelo - mean of 3 days of blood glucose before this dinner.~g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner with pomelo - mean of 3 days of blood glucose before this dinner."|9 days||||mmol/l||Standard Deviation|Mean
1335384|NCT02006836|Primary|∆g of Lunch With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after lunch were obtained and analyzed.~g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch without pomelo - mean of 3 days of blood glucose before this lunch.~g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch with pomelo- mean of 3 days of blood glucose before this lunch."|9 days||||mmol/l||Standard Deviation|Mean
1335385|NCT02006836|Primary|∆g of Breakfast With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after breakfast were obtained and analyzed.~g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."|9 days|The patients met the inclusion/exclusion criteria and completed the study.|||mmol/l||Standard Deviation|Mean
1335421|NCT02006654|Secondary|Clinical Improvement|Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
1335386|NCT02006836|Primary|Glycemic Index|"Glycemic index (GI) measurement was carried out after an overnight fast on 2 occasions in every subject, each test being separated from the next by a “washout” day.The first test day utilized 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of the Majia pomelos. Venous blood samples were collected and monitored during 3 hrs for both the healthy and T2DM individuals at 0, 30, 60, 90, 120, 150, and 180 min. Areas under the curves (AUC) of blood glucose concentrations were obtained. The 50 g of glucose was used as the reference (GI = 100) according to the literature. The AUC under the incremental glycemic-response curves for Majia were expressed as a percentage of the areas under the glucose curves for the same subject. The resulting values for all subjects were averaged to calculate the GI.~GI measurement is only calculated in case-control period."|3 days||||percentage of AUC from GI100||Standard Deviation|Mean
1335387|NCT02006732|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
1335388|NCT02006732|Secondary|TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS after combining the data from this and the replicate study NCT01964352|||Units on a scale||Standard Error|Mean
1335389|NCT02006732|Secondary|TDI Focal Score Based on Data From This Individual Study|"Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS|||Units on a scale||Standard Error|Mean
1335390|NCT02006732|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
1335391|NCT02006732|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS after combining the data from this and the replicate study NCT01964352|||units on a scale||Standard Error|Mean
1335392|NCT02006732|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study|"The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS|||units on a scale||Standard Error|Mean
1335393|NCT02006732|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
1335394|NCT02006732|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints.|||L||Standard Error|Mean
1335397|NCT02006719|Secondary|Change From Baseline to Day 95 in Adapted ASES Pain Subscale|"Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant overall assessment of pain in response to How bad is the pain in your affected shoulder today? using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5; adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation"|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 33 participants missing either baseline or day 95 pain subscale scores also excluded|||units on a scale||Standard Deviation|Mean
1335398|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive External Rotation|PROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive external rotation measurement also excluded|||degrees||Standard Deviation|Mean
1335399|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Internal Rotation|PROM measurement using a goniometer to assess internal rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive internal rotation measurement also excluded|||degrees||Standard Deviation|Mean
1335400|NCT02006719|Secondary|Change From Baseline to Day 95 in Active External Rotation|AROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active external rotation measurement also excluded|||degrees||Standard Deviation|Mean
1335401|NCT02006719|Secondary|Change From Baseline to Day 95 in Active Internal Rotation|AROM measurement using a goniometer to assess internal rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active internal rotation measurement also excluded|||degrees||Standard Deviation|Mean
1335402|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Abduction|PROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive abduction measurement also excluded|||degrees||Standard Deviation|Mean
1335403|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Forward Flexion|Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded|||degrees||Standard Deviation|Mean
1335404|NCT02006719|Secondary|Change From Baseline to Day 95 in Active Abduction|AROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active abduction measurement also excluded|||degrees||Standard Deviation|Mean
1335405|NCT02006719|Secondary|Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS)|"Participant assessment of pain in response to How bad is the pain upon movement of your affected shoulder at its worst in the last 24 hours? using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be."|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 33 participants missing either baseline or day 95 pain with movement scores also excluded|||units on a scale||Standard Deviation|Mean
1335406|NCT02006719|Secondary|Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale|Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation (United States adapted version).|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 34 participants missing either baseline or day 95 function subscale scores also excluded|||units on a scale||Standard Deviation|Mean
1335407|NCT02006719|Primary|Change From Baseline to Day 95 in Active Forward Flexion|Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded|||degrees||Standard Deviation|Mean
1335408|NCT02006706|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 24|PP Population|||score on a scale||Standard Deviation|Mean
1335409|NCT02006706|Primary|Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24|DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 24|Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.|||score on a scale||Standard Deviation|Mean
1335410|NCT02006667|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS|||percentage of participants|||Number
1335411|NCT02006667|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Screening, and Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
1335412|NCT02006667|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to OS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS|||months||95% Confidence Interval|Median
1335413|NCT02006667|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS|||percentage of participants|||Number
1335414|NCT02006667|Primary|Percentage of Participants Who Were Progression Free at 12 and 24 Months||Screening, and Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
1335415|NCT02006667|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first dose of study treatment to PFS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS|||months||95% Confidence Interval|Median
1335416|NCT02006667|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS|||percentage of participants|||Number
1335417|NCT02006654|Secondary|Change in Health-related Quality of Life (EQ-5D VAS)|"Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335418|NCT02006654|Secondary|Change in Health-related Quality of Life (EQ-5D) Utility Score|"Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335419|NCT02006654|Secondary|Change in Cognitive Aspects of Mental Function|"Change from baseline to Week 24 in Mini Mental State Examination (MMSE).~The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335420|NCT02006654|Secondary|Clinical Worsening|Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
1335524|NCT02004886|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 28 days|Safety Population included all randomized participants who initiated study therapy.|||Number of Participants|||Number
1335422|NCT02006654|Secondary|Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline|"Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed|||units on a scale||Standard Error|Least Squares Mean
1335423|NCT02006654|Secondary|Change in Individual Behavioural Disturbance Items|"Change in single NPI item scores at Week 24.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed|||units on a scale||Standard Error|Least Squares Mean
1335424|NCT02006654|Secondary|Change in Behavioural Disturbance|"Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335425|NCT02006654|Secondary|Change in Daily Functioning|"Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.~The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335426|NCT02006654|Secondary|Change in Global Impression|"Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.~The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335427|NCT02006654|Primary|Change in Cognition|"Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.~The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335428|NCT02006641|Secondary|Change in Health-related Quality of Life (EQ-5D VAS)|"Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1340470|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335429|NCT02006641|Secondary|Change in Health-related Quality of Life (EQ-5D) Utility Score|"Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335430|NCT02006641|Secondary|Change in Cognitive Aspects of Mental Function|Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335431|NCT02006641|Secondary|Number of Participants With Clinical Worsening|Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
1335432|NCT02006641|Secondary|Number of Participants With Clinical Improvement|Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
1335433|NCT02006641|Secondary|Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline|"Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed|||units on a scale||Standard Error|Least Squares Mean
1335434|NCT02006641|Secondary|Change in Individual Behavioural Disturbance Items|"Change in single NPI item scores at Week 24.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed|||units on a scale||Standard Error|Least Squares Mean
1335435|NCT02006641|Secondary|Change in Behavioural Disturbance|"Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335444|NCT02006342|Secondary|Intensive Care Unit Length of Stay|Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||days||Inter-Quartile Range|Median
1336842|NCT01982435|Secondary|Loss in Vision Greater Than or Equal to 15 Letters|Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12.|Months 6 and 12||||Participants|||Count of Participants
1335436|NCT02006641|Secondary|Change in Global Impression|"Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.~The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335437|NCT02006641|Secondary|Change in Daily Functioning|"Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.~The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335438|NCT02006641|Primary|Change in Cognition|"Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.~The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1335439|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months|Determine the change in cognitive test scores from baseline, at 6 months using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints (Baseline and 6 months) using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis based upon results in adults treated with radiation therapy is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will correlate with changes in global response as measured on COGState with the sub-domains on executive function most highly correlated. In addition, these regional changes in DTI will be directly related to the radiation doses received in these regions.|6 months|Data can not be accessed due to technical difficulties with the COGState server.||||||
1335440|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment.|Determine the change in cognitive test scores from baseline to time-points early during radiation therapy (3 and 6 weeks) using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will be measurable even in this acute setting and will correlate with global response as measured on COGState with the sub-domains on executive function anticipated to be most highly correlated.|Baseline, 3 weeks, and 6 weeks|Data can not be accessed due to technical difficulties with the COGState server.||||||
1335441|NCT02006407|Primary|Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy.|Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.|Baseline, 3 weeks, and 6 weeks|Because the outcome measure was CHANGE FROM BASELINE to 3 and 6 weeks, and data were not able to be collected at 3 and 6 weeks, the outcome measure could not be analyzed||||||
1335442|NCT02006342|Secondary|Number of Participants Who Developed Hypoglycemia|"To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure.~Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production."|Participants monitored during the 24 hours after anion gap closure|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||participants|||Number
1335443|NCT02006342|Secondary|Hospital Length of Stay|Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||days||Standard Error|Mean
1335445|NCT02006342|Secondary|Number of Participants Admitted to the ICU|The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis.|Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||participants|||Number
1335446|NCT02006342|Primary|Time to Anion Gap Closure|Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||hours||Standard Error|Mean
1335447|NCT02006264|Secondary|TFV-DP C-ave in Cervical Tissue|TFV-DP (tenofovir diphosphate) average concentration (C-ave) in cervical tissue. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|before and after 14 days of vaginal ring use|PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||fmol/mg||Inter-Quartile Range|Median
1335448|NCT02006264|Secondary|TFV C-ave in Cervical Tissue|TFV (tenofovir) average concentration (C-ave) in cervical tissue. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|before and after 14 days of vaginal ring use|PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||ng/mg||Inter-Quartile Range|Median
1335449|NCT02006264|Secondary|TDF AUC0-14 in CVF Genital Secretions (ECX and VAG), TFV AUC0-14 in CVF Genital Secretions (ECX and VAG), and TFV AUC0-14 in Plasma|TDF (tenofovir disoproxil fumarate) AUC0-14 (Area Under the Curve (concentration versus time) days 0-14) in Cervicovaginal Fluid (CVF) genital secretions (ectocervix (ECX) and vagina(VAG)), TFV AUC0-14 in CVF genital secretions (ECX and VAG), and TFV (tenofovir) AUC0-14 in Plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|1, 3, 7 and 14 days after ring insertion and 2 and 7 days after ring removal|TDF analytical data available for 13 of 15 participants for CVF ECX, and 14 of 15 participants for CVF VAG. TFV analytical data available for 13 of 15 participants for CVF ECX. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||ngxd/mL||Inter-Quartile Range|Median
1335450|NCT02006264|Secondary|TDF and TFV Time to Maximum Concentrations (T-max) in CVF Genital Secretions (ECX and VAG), and TFV Time to Maximum Concentration in Plasma|TDF (tenofovir disoproxil fumarate) and TFV (tenofovir) time to maximum concentrations (T-max) in CVF (Cervicovaginal Fluid) genital secretions (ectocervix (ECX) and vagina (VAG)), and TFV time to maximum concentration in Plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|1, 3, 7 and 14 days after ring insertion and 2 and 7 days after ring removal|TDF analytical data available for 14 of 15 participants for CVF VAG and CVF ECX. TFV analytical data available for 12 of 15 participants for Plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||h||Inter-Quartile Range|Median
1335451|NCT02006264|Secondary|TDF and TFV Maximum Concentrations (C-max) in CVF Genital Secretions (ECX and VAG) and TFV Maximum Concentration in Plasma|TDF (tenofovir disoproxil fumarate) and TFV (tenofovir) maximum concentrations (C-max) in CVF (Cervicovaginal Fluid) genital secretions (ectocervix (ECX) and vagina (VAG)) and TFV maximum concentration (C-max) in plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|1, 3, 7 and 14 days after ring insertion and 2 and 7 days after ring removal|TDF analytical data available for 14 of 15 participants for CVF VAG and CVF ECX. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||ng/mL||Inter-Quartile Range|Median
1335452|NCT02006264|Primary|Grade 2 or Higher Adverse Events as Defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events|Grade 2 or higher systemic and local Adverse Events as defined by the Division of Aids (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events during the trial period|14 days of vaginal ring use||||Adverse events|||Number
1335453|NCT02006264|Primary|Grade 1 Genitourinary Events or Higher as Defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events|Grade 1 or higher Genitourinary events as defined by the DAIDS (Division of AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events during the trial period judged to be related to study product|14 days of vaginal ring use||||Adverse events|||Number
1335454|NCT02006108|Secondary|Correlation of Cell-bound Iron Quantities on QSM Sequences With Macrophage and Iron Stains on Histopathology|To evaluate our ability to quantify cell-bound iron using the novel QSM sequence, we use histopathological data showing 1) the iron content of renal tissue sampled, and 2) the level of macrophage infiltration of the renal tissue. We will perform iron and macrophage stains in biopsy tissues in order to determine this.|3 weeks|CD163 positive macrophages|||correlation coefficient|||Number
1335455|NCT02006108|Primary|Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps|According to the study hypothesis, macrophage infiltration into rejected kidneys will be significantly greater than in healthy kidneys; since macrophages are expected to phagocytose injected iron, there should be a detectable difference in signal intensity between healthy and rejected organs. This can be evaluated using semiquantitative T2* maps.|24 hours to 7 days|T2* value of transplant kidney|||ms (delayed postcontrast scans)||Standard Deviation|Mean
1335467|NCT02005562|Secondary|Time to Graft Loss|The median time, in days, from randomization to graft loss event. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||days||Full Range|Median
1335468|NCT02005562|Secondary|Graft Loss - Percentage of Participants With an Event|Graft loss was defined as physical loss (nephrectomy), functional loss [necessitating maintenance dialysis for greater than (>)8 weeks], retransplant or death. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||percentage of participants|||Number
1335469|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population|||percentage of participants|||Number
1335456|NCT02006056|Other Pre-specified|Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)|"Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life.~Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days.~Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?"|Day 7|Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.|||units on a scale||Standard Error|Mean
1335457|NCT02006056|Other Pre-specified|Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)|"Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life.~Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days.~Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?"|Day 3|Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.|||units on a scale||Standard Error|Mean
1335458|NCT02006056|Other Pre-specified|The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.|Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.|Day 6-10 of treatment|Combined patients from primary prophylaxis and secondary prophylaxis arms, due to the low number of patients in the secondary prophylaxis arm (n=4).|||units on a scale||Standard Deviation|Mean
1335459|NCT02006056|Other Pre-specified|The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.|Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.|Day 0-5 during treatment|The primary prophylaxis arm and secondary prophylaxis arm patients were combined and analysed together, because the secondary prophylaxis arm had only 4 patients, which was too low to draw any meaningful conclusions.|||units on a scale||Standard Deviation|Mean
1335460|NCT02006056|Primary|Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.|"The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases.~Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline.~Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy.~Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication."|Day 0 - Day 10|"The results here encompass the primary outcome measure the proportion of patients with complete prophylaxis and partial control, which is repeated in the secondary outcome. The secondary outcome Time to nausea, vomiting and/or use of rescue medication is unavailable due to the data not being collected/analysed."|||Participants|||Count of Participants
1335461|NCT02005692|Primary|Turn Protocol Compliance|The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.|Subjects will be followed for the length of hospital stay which is expected to average 5 days.||||percentage turn compliance||95% Confidence Interval|Number
1335462|NCT02005692|Primary|Safety Primary Endpoint|The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.|Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.||||percentage of subjects with ADEs|||Number
1335463|NCT02005601|Secondary|Nausea Severity|Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).|POD 1||||units on a scale||Standard Deviation|Mean
1335464|NCT02005601|Secondary|Total Daily Opioid Use (mg Oral Morphine Equivalents)|Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.|POD 1||||mg oral morphine equivalents||Standard Deviation|Mean
1335465|NCT02005601|Primary|NRS Pain With Ambulation at 2 Weeks|When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?|2 weeks after surgery||||NRS pain score||Standard Deviation|Mean
1335466|NCT02005562|Secondary|Participant Survival|Participants survival was defined as the percentage of participants living with or without a functioning graft between Weeks 0 and 52. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||percentage of participants|||Number
1335471|NCT02005562|Secondary|Percentage of Participants With at Least One BPAR at Week 12 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population; only participants with at least one assessed biopsy were included in the analysis.|||percentage of participants|||Number
1335472|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||days||95% Confidence Interval|Median
1335473|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||percentage of participants|||Number
1335474|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the MDRD simplified equation. For males, the MDRD simplified equation was defined as MDRD (mL/min/1.73 square meters [m^2]) =186 multiplied by (*) serum creatinine in mg/L raised to the power of (^) -1.154 * age ^ -0.203. For females, the MDRD simplified equation was defined as MDRD (mL/min/1.73 m^2) = males formula * 0.742.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Deviation|Mean
1335475|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the Cockcroft-Gault equation.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
1335476|NCT02005562|Secondary|Serum Creatinine Values [Micromoles Per Liter (µmol/L)]|The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; number (n) = number of participants assessed for the specified parameter at a given visit.|||µmol/L||Standard Deviation|Mean
1335477|NCT02005562|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.|Week 12|ITT population; only participants with available protocol biopsy at Week 12 and/or a BPAR before Week 12 were included in the analysis.|||percentage of participants|||Number
1335478|NCT02005549|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)|20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population.|||percentage of participants||95% Confidence Interval|Number
1335479|NCT02005549|Secondary|Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)|Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.|||percentage of participants||95% Confidence Interval|Number
1335480|NCT02005549|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.|||percentage of participants||95% Confidence Interval|Number
1335481|NCT02005536|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received study vaccine (Safety Analysis Set).|||Number of participants|||Number
1335482|NCT02005536|Secondary|Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®|Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.|Day 28 post-booster vaccination|Geometric mean of individual titer ratios were assessed in the per-protocol analysis set.|||Titer Ratio||95% Confidence Interval|Geometric Mean
1335483|NCT02005536|Secondary|Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®|Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.|||Percentage of participants|||Number
1335484|NCT02005536|Secondary|Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®|Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Geometric mean titers was assessed in the per-protocol analysis set.|||Titers||95% Confidence Interval|Geometric Mean
1335485|NCT02005536|Primary|Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®|A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 28 post-vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.|||Percentage of participants|||Number
1335486|NCT02005484|Secondary|Time to Progression|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||months||Full Range|Median
1335487|NCT02005484|Secondary|Time to Progression - Number of Participants With an Event|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||participants|||Number
1335488|NCT02005484|Secondary|Overall Survival|Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||months||Full Range|Median
1335489|NCT02005484|Secondary|Overall Survival - Number of Participants Who Died|OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||participants|||Number
1335490|NCT02005484|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.|Weekly throughout the study|ITT population|||percentage participants|||Number
1335491|NCT02005484|Secondary|Percentage of Participants With Clinical Benefit|Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD. Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable SD: not qualifying for CR, PR, or PD.|Weekly throughout the study|ITT population|||percentage participants|||Number
1335492|NCT02005484|Primary|Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category|Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).|Weekly throughout study|ITT population|||percentage of participants|||Number
1335493|NCT02005393|Primary|Image Quality Scores Using Likert Scale|"Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI.~Likert Scores:~Not seen;~poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible;~good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging;~very good; allows an excellent assesssment, anatomical details are clearly defined; details clear"|One day|All patients had imaging done with both FICE, immediately followed by NBI. Images for one subject were not included in the Reader Study due to an error on the Compact Flash card which resulted in three (3) corrupt FICE images (FICE settings 0, 1 & 2); therefore making 19 out of 20 participants analyzed.|||units on a scale||Standard Deviation|Mean
1335494|NCT02005211|Primary|Safety - Adverse Events|Safety - Number of subjects reporting any adverse events during the study|Day of first dose to follow up|Safety|||Participants|||Number
1335495|NCT02005211|Secondary|Biomarker|Biomarker (Abeta 1-40; A beta 1-42) % change from baseline|Pre dose vs Day 14|Pharmacodynamic|||% change from baseline||Standard Deviation|Mean
1335498|NCT02005029|Secondary|Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo|Mean Cmax of plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels throughout the study and was thus excluded from the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1335499|NCT02005029|Secondary|MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)|Part 3 of this scale is a standardized physical assessment that quantifies the total burden of motor symptoms in Parkinson's disease patients. Each of the 18 items on the scale is rated from 0 (none, 1 (slight), 2 (mild), 3 (moderate) and 4 (severe). Scores range from 0-72. Higher scores represent a more severe burden of motor symptoms (a worse outcome).|2 weeks, between visits 2 and 3|One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||units on a scale||Standard Deviation|Mean
1335500|NCT02005029|Secondary|Change in Dyskinesia|Mean total AIMS (Abnormal Involuntary Movements Scale) score after receiving erythromycin minus mean total AIMS score after receiving placebo. The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. Ten of the items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the items are not scored. Total score range is from 0 to 40. Higher scores represent more severe dyskinesia (a worse outcome).|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||units on a scale||Standard Deviation|Mean
1335501|NCT02005029|Secondary|Timed up and go Test (TUAG) Fast Speed|Change in motor function as assessed by timed up and go test (fast speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
1335502|NCT02005029|Secondary|Timed up and go Test (TUAG) Comfortable Speed|Change in motor function as assessed by timed up and go test (comfortable speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
1335503|NCT02005029|Secondary|Comfortable 20 Feet Gait Speed (CGS)|Change in motor function as assessed by comfortable 20 feet gait speed (CGS)|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
1335504|NCT02005029|Secondary|Five Times Sit-to-stand Test|Change in motor function as measured by Five times sit-to-stand test. This test measures the total time to complete 5 repetitions of sit to stand.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
1335505|NCT02005029|Secondary|9-hole Peg Test Left Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
1335506|NCT02005029|Secondary|9-hole Peg Test Right Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
1335507|NCT02005029|Primary|Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo|Mean Area under the Curve 0-4 hours for plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels through out the study and was thus excluded from the pharmacokinetic analysis.|||ng/mL*min||Standard Deviation|Mean
1335508|NCT02005029|Primary|Gastric Emptying Time|Mean gastric emptying time in minutes as measured by SmartPill|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and four participants were unable to complete a SmartPill evaluation.|||minutes||Standard Deviation|Mean
1335509|NCT02004990|Secondary|Dental Plaque Composition Measured by Numbers of Bacteria Present|Dental plaque is a multispecies bacterial biofilm and the specific bacteria populating this biofilm will be measured. Measurement will be change in thickness of the biofilm|2-4 weeks||||micrometers||Standard Deviation|Mean
1335510|NCT02004990|Primary|Dental Plaque Levels Measures on Scale of 0-2|Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)|2-4 weeks||||units on a scale||Standard Deviation|Mean
1335523|NCT02004886|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
1335511|NCT02004977|Other Pre-specified|Social Support|Change in social support from baseline to SY2. Assessment of social support for breakfast was measured by asking the students to consider a typical month and record how often the following people encouraged them to eat or continue to eat breakfast at school: (1) parent/guardian, (2) friend, (3) other kids at my school, (4) teacher, and (5) other school staff. A 4-point Likert-type scale (disagree to agree, 0-4) for each of the categories was used. The total scale summed the five categories. The scale ranged from 0-20, a higher score indicates more social support.|Change in perceived support from baseline at the end of the school year (SY2)||||scores on a scale||Standard Deviation|Mean
1335512|NCT02004977|Other Pre-specified|Change From Baseline in Healthy Eating Index Scores|Change in the total Healthy Eating Index score from baseline to SY2. The Healthy Eating Index (HEI) score is a measure of diet quality. HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet|Change from baseline in Healthy Eating Index at the end of the school year (SY2).|The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) HEI measures in all of the enrolled students.|||Healthy Eating Index Total Score||Standard Deviation|Mean
1335513|NCT02004977|Secondary|Change From Baseline in Percent Body Fat|Student percent body fat will be measured by trained research staff|Change from baseline in student body fat at the end of the school year (SY2)|The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) % body fat measures in all of the enrolled students.|||% Body Fat||Standard Deviation|Mean
1335514|NCT02004977|Secondary|Change From Baseline in Body Mass Index|Change from baseline to the end of one school year (SY2) in body mass index.|Change from baseline (SY1) in student body mass index at the end of one school year (SY2).|The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) BMI measures in all of the enrolled students.|||kg/m^2||Standard Deviation|Mean
1335515|NCT02004977|Primary|Change From Baseline in Percent Students Eating the School Breakfast Per School|Change in participation in the reimbursable school breakfast program will be evaluated from school provided objective participation data from baseline (SY1) to the end of one school year (SY2)|Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).||||% School Breakfast Participation|Schools|Standard Deviation|Mean
1335516|NCT02004886|Secondary|Change From Baseline in 3-hour Insulin Total AUC at Week 4|Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||µIU hr/mL||95% Confidence Interval|Least Squares Mean
1335517|NCT02004886|Secondary|Change From Baseline in 3-hour AUC for C-peptide at Week 4|Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||ng hr/mL||95% Confidence Interval|Least Squares Mean
1335518|NCT02004886|Secondary|Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4|Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg hr/dL||95% Confidence Interval|Least Squares Mean
1335519|NCT02004886|Secondary|Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4|2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
1335520|NCT02004886|Secondary|Change From Baseline in Fasting Insulin at Week 4|Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||μIU/mL||95% Confidence Interval|Least Squares Mean
1335521|NCT02004886|Secondary|Change From Baseline in Fasting C-peptide at Week 4|Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||ng/mL||95% Confidence Interval|Least Squares Mean
1335522|NCT02004886|Secondary|Change From Baseline in Fructosamine at Week 4|Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
1336121|NCT01994486|Secondary|Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007|Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.|1/17/2014-3/26/2014||||ng/mL||Standard Deviation|Geometric Mean
1335525|NCT02004886|Primary|Number of Participants Experiencing an Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 42 days|Safety Population included all randomized participants who initiated study therapy.|||Number of Participants|||Number
1335526|NCT02004886|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
1335527|NCT02004873|Secondary|Rate Response Operation of Micra|Assessment of whether the Micra sensor-indicated rate derived from the input of the accelerometer during the Minnesota Pacemaker Response Exercise Protocol (M-PREP) treadmill test conducted at the 3-month and 6-month follow-up visits was proportional to the workload. The sensor-indicated rate (in min^-1) and workload (in METS) were normalized for each subject relative to their minimum and maximum possible values so the normalized values have a minimum possible value of zero and a maximum possible value of 1. These normalized values were used in a random effect linear regression model to assess the relationship between the sensor-indicated rate and workload via estimation of the Kay-Wilkoff slope parameter. The tests at 3-month and 6-month visits were combined in one analysis.|3 Months and 6 Months Post Implant (combined analysis)|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.|||regression slope parameter|M-PREP tests|90% Confidence Interval|Mean
1335528|NCT02004873|Secondary|Ventricular Capture Management Threshold|Subjects that have a ventricular capture management threshold (VCMT) that is within 0.5 Volts of the manual (auto decrement) PCT (at 0.24 ms pulse width) at the 6-month post-implant visit. The VCMT is an automatically measured pacing capture threshold that is measured by the Micra device’s pacing algorithm. In contrast, the manual (auto decrement) pacing capture threshold is measured by the clinician during a study visit.|6 Months Post Implant|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.|||participants|||Number
1335529|NCT02004873|Primary|Pacing Capture Threshold|Subjects that have an adequate pacing capture threshold (PCT) at the 6-month post-implant visit, which is defined as PCT <=2 volts at 0.24 ms pulse width and the increase in PCT from implant to 6 months <=1.5 volts. The pacing capture threshold is the minimal electrical stimulus required to produce consistent cardiac depolarization. It is the minimum amount of energy that is required for a pacemaker to pace the heart.|6 Months Post Implant|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (at 0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.|||participants|||Number
1335530|NCT02004873|Primary|Major Complications|Micra system and/or procedure related major complication free rate at 6-months post-implant.|Implant to 6 Months Post Implant|All subjects who attempted Micra implant procedure|||Kaplan-Meier survival probability (%)||98.66% Confidence Interval|Number
1335531|NCT02004847|Other Pre-specified|Patient Acceptance of Hyperpigmentation|Questionaire|week 16|Safety set (SAF)|||percentage of participants|||Number
1335532|NCT02004847|Other Pre-specified|Thermal Comfort|Questionaire|week 12|Full Analysis Set|||percentage of participants|||Number
1335533|NCT02004847|Secondary|Adverse Device Events (Serious and Non-serious)|"Adverse device events: Adverse event related to the use of an investigational medical device wich led to any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons.~Serious adverse device event: Adverse device effect that has resulted in a) led to death, b) led to serious deterioration in the health of the subject, that either resulted in 1) a life-threatening illness or injury, or 2) a permanent impairment of a body structure or a body function, or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) led to foetal distress, foetal death or a congenital abnormality or birth defect."|week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)|||number of participants|||Number
1335534|NCT02004847|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)|||number of participants|||Number
1335535|NCT02004847|Other Pre-specified|"Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter"|Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels.|week 4, 12, 16|Safety Set (SAF)|||arbitrary units||Standard Deviation|Mean
1335536|NCT02004847|Secondary|Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||week 16|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D|||days||Standard Deviation|Mean
1335537|NCT02004847|Secondary|Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||patients will be followed for the complete duration of the clinical study for 16 weeks|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D|||days||Standard Deviation|Mean
1335538|NCT02004847|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|It is a simple 10-question validated questionnaire. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. As the change from baseline is calculated negative values in the Outcome Measure Data indicate an improvement in quality of life.|baseline and week 12|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
1335566|NCT02004158|Primary|Self-reported Psychological Impact of Exercises|Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.|8 weeks||||points||Standard Deviation|Mean
1335539|NCT02004847|Secondary|System Usability Scale|At the end of treatment (visit 7), the usability of the investigational device was evaluated by a questionnaire presented to the patient in German. The usability was evaluated by using the System Usability Scale (SUS) which is an effective tool for assessing the usability of a device. It provides an easy-to-understand score from 0 (negative) to 100 (positive).|week 12|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 for HI group. Only 17 of 22 patients completed the questionaire in the LI group.|||units on a scale||Standard Deviation|Mean
1335540|NCT02004847|Secondary|Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|week 12 and week 16|Full Analysis Set (FAS); due to one drop out in each group this number is 23 for HI Group and 22 for LI group at week 12 and 16|||arbitrary units||Standard Deviation|Mean
1335541|NCT02004847|Secondary|Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|baseline and week 4, 12|Full Analysis Set (FAS)|||arbitrary units||Standard Deviation|Mean
1335542|NCT02004847|Secondary|Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0. = no sign~= slight~= moderate~= marked~= very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12)."|baseline and week 4, 8, 16|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
1335543|NCT02004847|Secondary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4, 12, 16|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
1335544|NCT02004847|Secondary|Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|Week 12 and week 16|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16|||units on a scale||Standard Deviation|Mean
1335545|NCT02004847|Secondary|Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1335546|NCT02004847|Primary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).|"In this study only the “local” PASI (also called local psoriasis severity index – LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 12|Full Analysis set (FAS)|||units on a scale||Standard Deviation|Mean
1335547|NCT02004262|Secondary|Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen|Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs.|From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.|Analysis conducted for the FAS of each study arm.|||Participants|||Count of Participants
1335548|NCT02004262|Primary|2nd-line Cohort: OS (All Data, FAS)|For all treated subjects, OS was calculated using KM methods with 70% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis cut. 70% CIs were selected to provide an 80% probability to rule out differences in median survival less than -2.4 months between the 2nd-line Cohort: Chemotherapy arm and the 2nd-line Cohort: Cy/GVAX + CRS-207 and 2nd-line Cohort: CRS-207 arms, based upon the assumptions made in the statistical analysis plan (SAP).|Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.|Analysis based on subjects in the 2nd-line Cohort in the FAS.|||months||70% Confidence Interval|Median
1335549|NCT02004262|Primary|Primary Cohort: OS (All Data, FAS)|For all treated subjects, OS was calculated using KM methods with 95% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis data cut.|Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.|Analysis based on subjects in the Primary Cohort in the FAS.|||months||95% Confidence Interval|Median
1336152|NCT01993888|Secondary|Incidence of Adverse Events (AEs)||Up to 60-days following surgery||||participants|||Number
1335550|NCT02004262|Primary|Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set)|OS was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs), with censoring at the date when 138 deaths were reached in the Primary Cohort in the FAS. Subjects without documentation of death at the time of final analysis were censored as of the date the subject was last known to be alive on/prior to the primary analysis data cut.|Subjects were followed from date of randomization to the date of death by any cause, whichever came first, assessed up to 32 months. Analysis conducted when 138 deaths reached in the Primary Cohort in the FAS.|Analysis based on subjects in the Primary Cohort in the intent-to-treat (ITT) set. The ITT set is the analysis population that included all randomized study subjects.|||months||95% Confidence Interval|Median
1335551|NCT02004236|Secondary|P3b Wave Amplitude After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
1335552|NCT02004236|Secondary|Commission Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||number of errors during ECPT task||Standard Deviation|Mean
1335553|NCT02004236|Secondary|Ommision Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||2017-12-31|12/2017||||
1335554|NCT02004236|Secondary|Reaction Time After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||Milliseconds||Standard Deviation|Mean
1335555|NCT02004236|Secondary|P3b Wave Amplitude Before tRNS|ERP and behaviour Changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
1335556|NCT02004236|Secondary|Commission Errors Before tRNS|ERP and Behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions||||number of errors during ECPT task||Standard Deviation|Median
1335557|NCT02004236|Secondary|Omission Errors Before tRNS|ERP and behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions||||number of errors during ECPT task||Standard Deviation|Mean
1335558|NCT02004236|Secondary|Reaction Time in ECPT Before tRNS|ERP & Behaviour changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||Milliseconds||Standard Deviation|Mean
1335559|NCT02004236|Secondary|Theta Amplitude in T5 After tRNS|Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
1335560|NCT02004236|Secondary|Ratio Theta/Beta After tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions||||Ratio theta/beta after tRNS||Standard Deviation|Mean
1335561|NCT02004236|Secondary|Theta Amplitude in T5 Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
1335562|NCT02004236|Secondary|Ratio Theta/Beta Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions||||Ratio theta/beta before tRNS||Standard Deviation|Mean
1335563|NCT02004236|Primary|Sociability|"Goal: Evaluate emphaty with CARS scale in autism spectrum disorder children between 5 and 12 years after tRNS sessions.~CARS (Childhood Autism Rating Scale) by Shopler & Reichler (1971) in Spanish version EVAI (Escala de Valoración de Autismo Infantil) by Leal-Soto, F.; Aguirre, L.P. y Williams, E.E.~Description: 15 items in the scale that evaluate: Relating to people, Imitative Behavior, Emotional Response, Body Use, Object Use, Adaptation to Change, Visual Response, Listening Response, Perceptive Response, Fear or Anxiety, Verbal Communication, Non-Verbal Communication, Activity level, Level and consistency of Intellective Relations and General Impressions.~Values: The CARS scores range from 15 to 60, with lower scores indicating better outcome. It classifies the child as not autistic (below 30), moderately autistic (30-36.5) or severely autistic (above 36.5)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.|||units on a scale||Standard Deviation|Mean
1335564|NCT02004236|Primary|Verbal Fluency|"Goal: Improve in verbal fluency in ASD children between 5 and 12 years. We use D-KEFS (Delis-Kaplan Executive Function System Delis Kaplan Sorting Test), Verbal Fluency Subtest - Category Condition.~Description: The verbal fluency Category test evaluates fluent productivity in the verbal domain by asking participants to generate exemplars belonging to the category animals, and subsequently, boys´ names. Participants were given 60 s to do it.~Values: Category scores were based on the average number of items generated in the two categories (animals and boys´names) during 60 s.~Time Frame: Baseline (Before treatment) and 1 day Post-treatment (after completing 3 months of intensive speech therapy during tRNS sessions)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.|||units on a scale||Standard Deviation|Mean
1335565|NCT02004158|Secondary|Objective Psychological Impact of Exercises|"Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:~Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)~Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)~Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).~Objective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline."|8 weeks||||points||Standard Deviation|Mean
1335569|NCT02004132|Secondary|Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts|"This is a summary of the amounts of testosterone measured on unworn textile items washed with t-shirt halves exposed to testosterone in a standard washing machine. Total amounts of testosterone on each laundered item other than the t-shirt halves was calculated based on the weight of the fabric sample analyzed and the total weight of the item, assuming a uniform distribution of testosterone across each item as:~(weight of laundered item / weight of laundered sample) x amount of testosterone on laundered sample."|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.|||µg||Standard Deviation|Mean
1335570|NCT02004132|Secondary|Amount of Testosterone Following Laundering|This is a summary of the amounts of testosterone measured on a 10 cm × 10 cm of material excised from the underarm area of washed t-shirt halves following laundering in a standard washing machine.|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.|||µg||Standard Deviation|Mean
1335571|NCT02004132|Primary|Amount of Testosterone on T-shirts|This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.|12 hours after application of study drug|Full analysis set (FAS). Data from all enrolled participants completing the study.|||micrograms (µg)||Standard Deviation|Mean
1335572|NCT02004093|Secondary|Kaplan-Meier Probability of Being Alive at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||percent|||Number
1335573|NCT02004093|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis|||months||Full Range|Median
1335574|NCT02004093|Secondary|Percentage of Participants Who Died||Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis|||percentage of participants|||Number
1335575|NCT02004093|Secondary|Time To Response|Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|Only participants with a response were included in the analysis.|||weeks||Inter-Quartile Range|Median
1335576|NCT02004093|Primary|Kaplan-Meier Probability of No Disease or Progression at 1 Year|The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.|1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.|||percent|||Number
1335577|NCT02004093|Secondary|Kaplan-Meier Probability of Being Progression Free at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 16 and 10 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.|||percent|||Number
1335578|NCT02004093|Secondary|Time to Progressive Disease|The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated patients with an event (disease progression) were included in analysis|||weeks||Inter-Quartile Range|Median
1335579|NCT02004093|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated participants were included in analysis|||percentage of participants|||Number
1335580|NCT02004093|Secondary|Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 7 and 5 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.|||percent|||Number
1335581|NCT02004093|Secondary|Duration of Response|For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.|Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks|Only participants with a response were included in the analysis; 8 participants and 13 participants were censored in the chemotherapy + pertuzumab and chemotherapy only treatment groups, respectively.|||weeks||Inter-Quartile Range|Median
1335594|NCT02003924|Secondary|Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline – Chemistry|Chemistry parameters: Alanine aminotransferase (units per liter [U/L]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter [umol/L]); calcium (millimoles per liter [mmol/L]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
1336153|NCT01993888|Secondary|Incidence of Re-bleeding Events From the TBS During the Study Follow-up||Up to 60-days following surgery||||participants|||Number
1335582|NCT02004093|Secondary|Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements|Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were “response”, “stable disease” and “progressive disease”. Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of “response” or “progressive disease”.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||percentage of participants|||Number
1335583|NCT02004093|Primary|Progression-Free Survival|Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||weeks||Full Range|Median
1335584|NCT02004093|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated participants who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||percentage of participants|||Number
1335585|NCT02003963|Secondary|Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13|SE-HEPA is a 13-item self-report survey with items based on a 5-point Likert scale. Possible scores range from 1 (Disagree a Lot) to 5 (Agree a Lot). The items are summed to a total score, and a higher score indicates a higher level of self-efficacy (range: 13 to 65). Results are reported as change scores from baseline.|Baseline clinic visit (Week 0) and final clinic visit (Week 13)|Four participants refused to complete the final assessment.|||change scores on a scale||Standard Deviation|Mean
1335586|NCT02003963|Secondary|Change From Baseline in Health-related Quality of Life|Self-report instrument to capture health-related quality of life (KIDSCREEN-10 Index). The scale ranges from 5 to 50, with a higher score indicating a better quality of life.|Baseline clinic visit (week 0) and final clinic visit (week 13)||||change in units on a scale||Standard Error|Mean
1335587|NCT02003963|Secondary|The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13.|The outcome is perceived peer conflict from the Friendship Quality Questionnaire, which is a 21-item self-report survey in which the participant answers questions about his or her best friend related to companionship, conflict, help/aid, security, and closeness, on a 5-point Likert scale. The survey is internally consistent, with α ranging from 0.71 to 0.86, and adequate criterion validity across sub-scales. The peer conflict sub-scale includes four questions and ranges from 4 to 20 points. A higher score indicates higher (worse) levels of peer conflict.|Baseline clinic visit (week 0) and final clinic visit (week 13)||||change in units on a scale||Standard Error|Mean
1335588|NCT02003963|Secondary|Change in Physical Activity|Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument|Baseline clinic visit (week 0) and final clinic visit (week 13)|Data reported on participants with complete accelerometry data|||change in self-reported days/week of PA||Full Range|Mean
1335589|NCT02003963|Secondary|Feasibility|Attendance to exergaming intervention|3 gaming sessions/week for 12 weeks|"Attendance was only assessed for the Exergame Intervention participants"|||percentage exergaming sessions attended||Full Range|Mean
1335590|NCT02003963|Primary|Change in Resting Systolic Blood Pressure Percentile|Resting systolic blood pressure percentile|Baseline clinic visit (week 0) and final clinic visit (week 13)||||%ile||Standard Deviation|Mean
1335591|NCT02003963|Primary|Change in Visceral Adiposity|Assessed by magnetic resonance imaging|Baseline clinic visit (week 0) and final clinic visit (week 13)|Intent to treat. Three participants did not complete baseline or final MRI scan due to exceeding weight limit or metal-containing object in the body, and five participants refused to complete final MRI scan.|||kg||Standard Deviation|Mean
1335592|NCT02003963|Primary|Change in Body Fat|Assessed by dual energy x-ray absorptiometry|Baseline clinic visit (week 0) and final clinic visit (week 13)|Intent to treat|||kg||Standard Deviation|Mean
1335593|NCT02003924|Secondary|Number of Participants With Clinically Significant Vital Signs|Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
1335651|NCT02003014|Secondary|Change From Baseline in Immunoreactive Insulin (IRI)|The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free [unbound] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||micro units per milliliter (mcU/mL)||Standard Deviation|Mean
1335595|NCT02003924|Secondary|Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology|Hematology parameters: Haemoglobin (grams per liter [g/L]); leukocytes (log 10 raised to power 9 per liter [10*9/L]); lymphocytes (log 10 raised to power 6 per liter [10*6/L]); neutrophils (log 10 raised to power 6 per liter [10*6/L]); platelets (log 10 raised to power 9 per litre [10*9/L]).|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
1335596|NCT02003924|Secondary|Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
1335597|NCT02003924|Secondary|Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
1335598|NCT02003924|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
1335599|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: “Have you felt uncomfortable about being sexually intimate?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335600|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: “Did you have ejaculation problems (e.g, dry ejaculation)?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1336264|NCT01990898|Primary|Symptom Improvement of Interstitial Cystitis|Number of participants with > 30% Improved Interstitial Cystitis Symptoms Index (ICSI) which is measured on a scale from 0 - 19 where the higher numbers are worse. No additional analyses have been done.|3 Months||||Participants|||Number
1335601|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: “Did you have difficulty getting or maintaining an erection?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335602|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: “To what extent was sex enjoyable for you?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335603|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: “To what extent were you sexually active (with or without intercourse)?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335604|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: “To what extent were you interested in sex?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335605|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: “Have you felt less masculine as a result of your illness or treatment?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335606|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: “Has weight gain been a problem for you?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1336284|NCT01990794|Secondary|Cobalt Urine Concentrations|A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.|During cobalt supplementation|Participants that completed three months of cobalt supplementation|||µg/L||Standard Deviation|Mean
1335607|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: “Has weight loss been a problem for you?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335608|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: “Have you had swelling in your legs or ankles?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335609|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: “Have you had sore or enlarged nipples or breasts?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335610|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: “Did you have hot flushes?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335611|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: “Did you have a bloated feeling in your abdomen?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335612|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: “Have you had blood in your stools?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335775|NCT02000180|Secondary|Cognitive Knowledge of Endoscopy|Assessed via a multiple-choice question test on the theory and practice of endoscopy. Scores range from 0-100 with higher scores representing a more knowledge of the theory and practice of endoscopy.|Pre-training, immediate post-training||||percentage score on MCQ test||Standard Deviation|Mean
1335613|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: “Have you had any unintentional release (leakage) of stools?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335614|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: “Have your daily activities been limited by your bowel problems?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335615|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: “Have your daily activities been limited by your urinary problems?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335616|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: “Has wearing an incontinence aid been a problem for you?”. This question was answered by only those participants who wore incontinence aid.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335617|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: “Did you have pain when you urinated?”|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335618|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: “Have you had any unintentional release (leakage) of urine?”|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335619|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: “Have you had difficulty going out of the house because you needed to be close to a toilet?”|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335620|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: “Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?”|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335621|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: “When you felt the urge to pass urine, did you have to hurry to get to the toilet?”|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335622|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: “Have you had to urinate frequently at night?”|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335623|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31|The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: “Have you had to urinate frequently during the day?”|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335624|NCT02003924|Secondary|European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant’s self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
1335652|NCT02003014|Secondary|Change From Baseline in Body Weight|Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12).|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||kg||Standard Deviation|Mean
1335625|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335626|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335627|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
1335628|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||participants|||Number
1335629|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||participants|||Number
1335630|NCT02003924|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score|The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
1335631|NCT02003924|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.|From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Overall number of participants analyzed’ = participants with baseline and at least one post-baseline PSA assessment.|||percentage of participants||95% Confidence Interval|Number
1336843|NCT01982435|Secondary|Gain in Vision Greater Than or Equal to 15 Letters|Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12.|Months 6 and 12||||Participants|||Count of Participants
1335632|NCT02003924|Secondary|Chemotherapy-Free Survival|Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335633|NCT02003924|Secondary|Chemotherapy-Free Disease Specific Survival|Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335634|NCT02003924|Secondary|Time to First Use of Cytotoxic Chemotherapy|Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335635|NCT02003924|Secondary|Time to Pain Progression|Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: “Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours.” Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335636|NCT02003924|Secondary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.|From randomization until death or discontinuation from the study whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335637|NCT02003924|Secondary|Time to First Use of New Antineoplastic Therapy|Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335638|NCT02003924|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335653|NCT02003014|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1336844|NCT01982435|Secondary|Anatomically Dry Eyes by SDOCT|Number of participants with an anatomically “dry” study eye by SDOCT at months 6 and 12|Months 6 and 12||||Participants|||Count of Participants
1335639|NCT02003924|Primary|Metastasis Free Survival (MFS)|MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.|From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
1335640|NCT02003638|Primary|Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT||12 weeks||||Target to Background Ratio (TBR)||Standard Deviation|Mean
1335641|NCT02003534|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Month 3|Intent-to-Treat: patients with baseline data and data at the indicated time point|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1335642|NCT02003404|Primary|Skin Barrier Peel Force|Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.|4 hours||||grams||Standard Deviation|Mean
1335643|NCT02003391|Secondary|Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4|||Percent Change||Standard Deviation|Mean
1335644|NCT02003391|Secondary|Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4|||mmHg||Standard Deviation|Mean
1335645|NCT02003391|Primary|Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Week 4|Intent to treat with a measurement in the study eye at Week 4|||mmHg||95% Confidence Interval|Least Squares Mean
1335646|NCT02003365|Secondary|Plasma Drug Concentrations by Time|"Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ)."|Weeks 6, 12, 16 and 20||||pg/mL||95% Confidence Interval|Geometric Mean
1335647|NCT02003365|Primary|Concentration of Triamcinolone Acetonide in Synovial Fluid|"Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ)."|12 to 20 weeks|All patients who received study drug and had synovial fluid obtained at the Final Visit were included in the Synovial Fluid Drug Concentration Population.|||pg/mL||95% Confidence Interval|Geometric Mean
1335648|NCT02003352|Primary|Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)|The CAPS is the gold standard in PTSD assessment and is a 30-item structured interview.For each symptom, standardized questions and probes are provided. Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. The full interview takes 45-60 minutes to administer.CAPS symptom severity ratings are based on symptom frequency and intensity (except for amnesia and diminished interest which are based on amount and intensity). Higher scores represent a worse outcome with severity categories of 0-19 (minimal), 20-39 (mild), 40-59 (moderate), 60-79 (severe), 80-136 (extreme). We will use changes in the DSM-IV CAPS scores before and after treatment to distinguish between the estimated frequency and intensity of the various symptoms. Frequency and intensity scores will be combined to give a total CAPS score (range: 0–136) CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention.|up to 12 weeks|Changes in CAPS scores before-after. Frequency and intensity scores combined-CAPS score (range: 0–136) . CAPS pre-intervention, 1 week post-intervention, and at 3 months post-intervention. Difference pre and post of CAPS Scores (matched pairs) two-tailed t -Test with alpha of <0.05. Effect Size Cohen's D|||units on a scale||95% Confidence Interval|Mean
1335649|NCT02003053|Primary|Safety and Feasibility of Inspiratory Muscle Training|The number of patients tolerating Inspiratory Muscle Training or Sham.|Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)||||Participants|||Count of Participants
1335650|NCT02003014|Secondary|Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||HOMA-IR score||Standard Deviation|Mean
1335654|NCT02003014|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1335655|NCT02003014|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1335656|NCT02003014|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1335657|NCT02002936|Secondary|Changes in Clinical Laboratory Test Results|Clinically significant changes|Up to 3 years||||participants|||Number
1335658|NCT02002936|Secondary|Overall Survival|Survived|Up to 3 years||||participants|||Number
1335659|NCT02002936|Secondary|Cytogenetic Response Ratio According to IWG 2006 Criteria|NCA (not considered assessable): no cytogenetic response|Up to 3 years||||participants|||Number
1335660|NCT02002936|Secondary|Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.|NCA (not considered assessable): no evidence of HI-E (hematologic improvement-erythroid), HI-P (hematologic improvement-platelet), HI-N (hematologic improvement-neutorophil), progressive disease, or relapse.|Up to 3 years||||participants|||Number
1335661|NCT02002936|Secondary|Total Efficacy in Hematologic Remission (IWG2006 Criteria)|"SD (stable disease): according to International Working Group 2006 response criteria for myelodysplastic syndrome, SD was defined as a failure to achieve complete remission or partial remission, but no evidence of progression for > 8 weeks."|Up to 3 years||||participants|||Number
1335662|NCT02002936|Primary|Adverse Events|Total number affected by any adverse events (details are presented in adverse event section)|Up to 3 years||||participants|||Number
1335663|NCT02002871|Other Pre-specified|Number of Participants With Acceptance of Hyperpigmentation at Week 6|"Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering yes or no."|week 6|7 patients out of 20 patients reported hyperpigmentation at week 6.|||participants|||Number
1335664|NCT02002871|Other Pre-specified|Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)|Higher values describe a higher level of pigmentation.|week 6||||arbitrary units||Standard Deviation|Mean
1335665|NCT02002871|Other Pre-specified|Device Deficiencies|This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.|over 6 weeks||||participants|||Number
1335666|NCT02002871|Other Pre-specified|Adverse Device Events (Serious and Non-serious)||over 6 weeks||||participants|||Number
1335667|NCT02002871|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 2, 4, 6||||participants|||Number
1335668|NCT02002871|Other Pre-specified|Hyperpigmentation – Evaluation by Mexameter|Higher values describe a higher level of pigmentation.|week 0, 2, 4, 6||||arbitrary units||Standard Deviation|Mean
1335669|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Patient Rating of Itching of the Target Area as Compared to the Control Area at End of Follow-up|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).|week 6||||units on a scale||Standard Deviation|Mean
1335670|NCT02002871|Secondary|Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)|week 4, 6||||units on a scale||Standard Deviation|Mean
1335671|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area at End of Follow-up|Higher values describe a higher level of erythema.|week 6||||arbitrary units||Standard Deviation|Mean
1335672|NCT02002871|Secondary|Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area|Higher values describe higher erythema levels.|week 4, 6||||arbitrary units||Standard Deviation|Mean
1335673|NCT02002871|Secondary|Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|week 6||||units on a scale||Standard Deviation|Mean
1335674|NCT02002871|Primary|Change From Baseline (Visit 2) of the Sum Score of Local Eczema Rating of the Target Area as Compared to the Control Area at End of Treatment|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|at week 4|Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient.|||units on a scale||Standard Deviation|Mean
1335838|NCT01998906|Primary|Percentage of Participants Event Free at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
1335675|NCT02002702|Secondary|Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14|Neutrophil gelatinase-asc lipocalin (NGAL) biomarker was used to assess the effect of serelaxin on kidney function. Geometric means of the ratio of post-Baseline values to baseline values of NGAL was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
1335676|NCT02002702|Secondary|Change From Baseline in NT-proBNP Levels Through Day 14|NT-proBNP biomarker was used to assess the effect of serelaxinin on degree of cardiac wall stress and congestion. Geometric means of the ratio of post-Baseline values to baseline values of NT-proBNP was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
1335677|NCT02002702|Secondary|Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14|High sensitivity Troponin-T biomarker was used to assess the effect of serelaxin on myocardial damage. Geometric means of the ratio of post-Baseline values to baseline values of high sensitivity troponin-t was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
1335678|NCT02002702|Secondary|Change From Baseline in Cystatin-C Levels Through Day 14|Cystatin-C biomarker was used to assess the effect of serelaxinin on worsening of renal function. Geometric means of the ratio of post-Baseline values to baseline values of Cystatin-C was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
1335679|NCT02002702|Secondary|Change From Baseline in Aldosterone Levels Through Day 14|Aldosterone biomarker was used to assess the effect of serelaxinin on fluid retention. Geometric means of the ratio of post-Baseline values to baseline values of aldosterone was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
1335680|NCT02002702|Secondary|Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5|"The area under the curve (AUC) was defined as area under the plasma concentration-time curve from time zero to time of the last time point with measurable concentration, calculated by a trapezoidal method. Systolic blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 3 minutes at clinic during the visit. Sample collected at: Baseline; 30 & 60 minutes and then every hour for the first 6 hours of study drug infusion, and then every 3 hours during 48 hours of study drug infusion; every 3 hours until 12 hours following end of infusion, then every 6 hours for 48 hours and then every 24 hours until the earlier of Day 5 or discharge.~AUC for SBP is standardized by dividing by the length of respective time ranges."|Baseline, 48 hours, Day 5|The analysis was performed in the full analysis set (FAS) population, defined as all participants who were randomized in the study.|||mmHg||Standard Error|Least Squares Mean
1335681|NCT02002702|Primary|Concentration at Steady-state (Css) of Serelaxin|Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."|||ng/mL||Standard Deviation|Mean
1335682|NCT02002702|Primary|Weight Adjusted Clearance (CL) of Serelaxin|Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."|||mL/hr/kg||Standard Deviation|Mean
1335683|NCT02002702|Primary|Maximum Plasma Concentration (Cmax) of Serelaxin|Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the pharmacokinetic (PK) set, defined as all participants who received study treatment and had at least one evaluable PK parameter data. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."|||nanogram(s)/milliliter (ng/mL)||Standard Deviation|Mean
1335684|NCT02002702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.|From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)|The analysis was performed on the safety population, defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment.|||participants|||Number
1335685|NCT02002689|Secondary|Kaplan-Meier Estimates of Progression Free Survival (PFS )Timing, Months||4 months||||months||95% Confidence Interval|Median
1335839|NCT01998906|Secondary|Percentage of Participants Surviving at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
1335686|NCT02002689|Secondary|Summary of Timing and Estimated Rate for Progression-free Survival (PFS) – Full Analysis Set|Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.|4 months|Full Analysis set|||% progression free surviors||95% Confidence Interval|Number
1335687|NCT02002689|Primary|Summary of Overall Response (ORR) and Clinical Benefit (CBR)|Clinical benefit rate (CBR) Number and percentage of subjects with CBR (responses of CR, PR or SD ≥ 16 weeks) as assessed by investigator was reported for all patients along with 95% exact confidence interval (CI). Overall Response Rate (ORR) Overall response was to be determined by investigator assessment for each tumor in the study. For subjects with solid tumors, the assessment criteria was RECIST 1.1 and included responses of CR and/or PR. The number and percentage of subjects for different categories of overall response (e.g., for solid tumors – CR, PR, SD, PD, Not Evaluable) were to be provided for solid tumors, and each hematological tumor type (if applicable). Ninety-five percent (95%) exact CI was to be provided for the response rate(s) (e.g., for solid tumors – CRn and/or PR) as well.|16 weeks|Full analysis set|||percent responders|||Number
1335688|NCT02002650|Secondary|Moderate-to-severe Pancreatitis|Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).|30 days||||participants|||Number
1335689|NCT02002650|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.|30 days||||participants|||Number
1335690|NCT02002533|Secondary|Change in Mean Circadian Rhythm Acrophase Over 12 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The acrophase is the time where peak activity occurs over a 12 hour period. The larger the acrophase the later in the day is the peak activity.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||hours||Standard Deviation|Mean
1335691|NCT02002533|Secondary|Change in Mean Circadian Rhythm Acrophase Over 24 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The acrophase is the time where peak activity occurs over a 24 hour period. The larger the acrophase the later in the day is the peak activity.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||hours||Standard Deviation|Mean
1335692|NCT02002533|Secondary|Change in Circadian Rhythm Amplitude Over 12 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The amplitude is the highest activity level over a 12 hour period.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||log10 (counts/minute)||Standard Deviation|Mean
1335693|NCT02002533|Secondary|Change in Circadian Rhythm Amplitude Over 24 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The ampliitude is the peak activity level over a 24 hour period.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||log10 (counts/minute)||Standard Deviation|Mean
1335694|NCT02002533|Secondary|Change in Mean Circadian Rhythm Mesor|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The mesor is the average activity over a 24 hour period.|Baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||log activity counts||Standard Deviation|Mean
1335695|NCT02002533|Secondary|Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)|Each item is weighted on a 0–3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. The difference between arms will be assessed using ANCOVA. The response will be the post-intervention outcome. Arm will be the factor, and baseline will be the covariate. Appropriate contrasts will be used to estimate the difference between arms in change from baseline. Initially, the arm*baseline interaction will be assessed with an F test. If this interaction is insignificant at the 0.05 level, it will be dropped from the final model. If the interaction is significant, then mean change from baseline at various levels of baseline will be reported.|Baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||units on a scale||Standard Deviation|Mean
1335696|NCT02002533|Secondary|Change in Insomnia as Measured by the Insomnia Severity Index (ISI)|"The ISI has seven questions. The seven answers are added up to get a total score.~Total score categories:~0–7 = No clinically significant insomnia 8–14 = Subthreshold insomnia 15–21 = Clinical insomnia (moderate severity) 22–28 = Clinical insomnia (severe) The difference between arms will be assessed using analysis of covariance (ANCOVA). The response will be the post-intervention outcome. Arm will be the factor, and baseline will be the covariate. Appropriate contrasts will be used to estimate the difference between arms in change from baseline. Initially, the arm*baseline interaction will be assessed with an F test. If this interaction is insignificant at the 0.05 level, it will be dropped from the final model. If the interaction is significant, then mean change from baseline at various levels of baseline will be reported."|Baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||units on a scale||Standard Deviation|Mean
1335697|NCT02002533|Primary|Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings|Each NCORP staff person completed a study checklist in which they designated which concepts they discussed with the patient at each session. Concepts included how sleep problems develped, how to control stimulus, and sleeping environment. The overall mean percent delivery was measured using a random effects model (residual maximum likelihood [REML] estimation), where the intercept represents the mean delivery and three independent random effects are included. Because of the small sample size, testing will use the Kenward-Roger procedure.|Up to 1 month|This assessment was only performed for the BBT arm.|||percentage of components delivered||Standard Error|Mean
1335698|NCT02002533|Primary|Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT|Will be evaluated by calculating the specific percentage (with 95% confidence interval) and performing an exact binomial test with the null hypothesis being greater than or equal to 75%.|Up to 1 month|Data on HEAL subjects was not collected since the main focus was BBT, therefore only rate of adherence is shown for BBT group.|||percentage of participants||95% Confidence Interval|Number
1335699|NCT02002533|Primary|Percentage of Eligible Patients Consented|Will be evaluated by calculating the specific percentage (with 95% confidence interval) of the total number of participants approached that then consented and enrolled in the study.|baseline|92 people were approached to enroll in the study|||percentage of participants||95% Confidence Interval|Number
1335700|NCT02002221|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.|||Participants|||Number
1335701|NCT02002221|Secondary|Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia|Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.|||Participants|||Number
1335702|NCT02002221|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement. Number of patients with observations at both baseline and endpoint are analyzed in this endpoint.|||mg/dL||Standard Error|Least Squares Mean
1335703|NCT02002221|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.|||percentage of patients|||Number
1335704|NCT02002221|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1335705|NCT02002208|Secondary|Rate of Flares||over 16 weeks||||flares||Standard Deviation|Mean
1335706|NCT02002208|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16|The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1–1.0 almost clear; 1.1–7.0 mild; 7.1–21.0 =moderate; 21.1–50.0 severe; 50.1–72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.|EASI was measured at baseline (week 0) and 16 weeks after dosing.|Adjusted mean change from baseline EASI at Week 16|||units on a scale||Standard Error|Mean
1335707|NCT02001714|Secondary|Group Behavioral Treatment Cost-effectiveness|Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.|12 months|||||||
1335717|NCT02001051|Secondary|To Determine the Optimal Diagnostic Test for Subclinical Hypercortisolism|An assessment of whether 1 mg dexamethasone suppression test, basal adrenocorticotropic hormone (ACTH), midnight salivary cortisol, or urinary free cortisol is the optimal test to diagnose patients with subclinical hypercortisolism.|Assessed at 6 months|This outcome measure was not done. Data was collected and not analyzed because we were not able to determine the optimal test since we only had four patients enrolled, and three patients on study (e.g. low accrual). Therefore, we couldn’t do a head to head comparison calculating the sensitivity and specificity.||||||
1335718|NCT02001051|Secondary|Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan|Proportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan.|Assessed at 6 months||||proportion of participants|||Number
1335708|NCT02001714|Primary|Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.|The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.|Baseline and 3 months|The Group Behavioral Treatment group population at baseline is 232. At the 3 month follow-up visit 16 had withdrawn and 7 missed the appointment, leaving 209 for the total number analyzed. For the No Treatment group, the number at baseline is 231 and by the 3 month visit 8 had withdrawn and another 11 missed the appointment, leaving 212.|||units on a scale||Inter-Quartile Range|Median
1335709|NCT02001181|Secondary|Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4|The EASI Clinical Signs Severity Sum Score was derived from the EASI. The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region. The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.|||units on a scale||Standard Deviation|Mean
1335710|NCT02001181|Secondary|Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4|The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks. In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. What is reported is the percent change from baseline in BSA affected.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.|||percent change||Standard Deviation|Mean
1335711|NCT02001181|Secondary|Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.|||percentage of participants|||Number
1335712|NCT02001181|Secondary|Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.|||percentage of participants|||Number
1335713|NCT02001181|Primary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4|The EASI quantifies the severity of a participant’s atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.|Baseline (pre-dose on Day 1) and Week 4|The full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.|||percent change||Standard Error|Least Squares Mean
1335714|NCT02001051|Secondary|Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism|A skin biopsy and skin ultrasound were done to measure the dermal layer of skin to look for a decrease in the thickness of skin as compared to normal values reported in the literature as measured in millimeters of thickness. Diagnostic sensitivity and changes in skin thickness were assessed.|Assessed at 6 months||||Participants|||Count of Participants
1335715|NCT02001051|Secondary|Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism|Proportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not.|Assessed at 6 months||||proportion of participants|||Number
1335716|NCT02001051|Secondary|Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy|QOL questionnaires were provided to participants to assess well being pre and post operatively. Participants take a self-administered questionnaire to assess physical and mental health according to Cushing's Quality of Life Questionnaire. The score has a minimum of 12 and maximum of 60. A higher score indicates an improved quality of life.|Assessed at 6 months||||proportion of participants|||Number
1335719|NCT02001051|Secondary|Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy|Patients who were tested for and found to have adrenal cancer after adrenalectomy.|Assessed at 6 months||||proportion of participants|||Number
1338040|NCT01968135|Primary|Cessation of Vaginal Bleeding|Proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.|At day 3 of 14 day course of study drug||||percentage of participants|||Number
1335720|NCT02001051|Primary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 39 months and 27 days|No toxicities were experienced by any participants on this trial.|||Participants|||Count of Participants
1335721|NCT02001051|Primary|Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy|Normalization and/or improvement of metabolic complications including hypertension, diabetes, osteoporosis, hypercholesterolemia and/or obesity after adrenalectomy is defined as 35% of patients who improve with surgery versus 5% who do not have surgery.|Assessed at 6 months||||proportion of participants|||Number
1335722|NCT02000973|Secondary|Bispectral Index Score|The bispectral index(BIS) score of each patient was recorded at two different time points. BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|Before starting anesthesia to finishing endotracheal intubation||||units on a scale||Standard Deviation|Mean
1335723|NCT02000973|Secondary|Heart Rate|The heart rate of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation||||beats per minute||Standard Deviation|Mean
1335724|NCT02000973|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation||||mmHg||Standard Deviation|Mean
1335725|NCT02000973|Primary|Propofol Effect-site Concentration|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|Before starting anesthesia to finishing endotracheal intubation||||ug/ml||Standard Deviation|Mean
1335726|NCT02000921|Secondary|Carcinogen Exposure Biomarker: Total NNAL|Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.|Week 8 (end of intervention)||||pmol//mg creatinine||95% Confidence Interval|Mean
1335727|NCT02000921|Secondary|Rate of 24 Hour Quit Attempts|Rate of 24 hour quit attempts during the intervention period|8 week intervention period||||Participants|||Count of Participants
1335728|NCT02000921|Primary|Number of Combusted Products Smoked|Number of combusted products smoked per day during the last two weeks of the intervention period.|At weeks 6-8 (last two weeks of intervention period)||||combuster products per day||Standard Deviation|Mean
1335729|NCT02000921|Primary|Number of Days Using Alternative Products|The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.|8 week intervetnion period||||Number of days||Standard Deviation|Mean
1335730|NCT02000752|Secondary|Degree of Ease With Which the Acupuncturist Administered the Treatment|"The degree of ease with which the acupuncturist administered the treatment was measured in a survey that the midwife carries out no more than 2 hours after the labor. The value was recorded using a numerical scale ranging between 0-100, with 4 levels: 100 - high ease, 75 - moderate ease, 50 - medium ease and 25 - low ease"|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room||||units on a scale||Standard Deviation|Mean
1335731|NCT02000752|Secondary|Percentage of Mothers That Would Recommend the Technique to Any of Her Friends|"The number of mothers that would recommend the technique to any of her friends is analyzed in the survey that the midwife carries out no more than 2 hours after the labor. The possible responses are I would recommend it, or I would not recommend it."|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room||||percentage|||Number
1335732|NCT02000752|Secondary|Percentage of Participants Who Reported Experiencing Pain Related to Treatment|The existence of pain related to the treatment is analyzed by the survey that the midwife carries out no more than 2 hours after the labor. A scale with 4 levels was used (no pain, mild pain, moderate pain, great pain).|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room||||percentage|||Number
1335733|NCT02000752|Primary|The Principal Outcome of the Study is the Placental Expulsion Time.|This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.|Up to 30 minutes after the newborn delivery||||minutes||95% Confidence Interval|Mean
1335734|NCT02000622|Other Pre-specified|Time to Second Subsequent Cancer Therapy or Death (TSST)|Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.|Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
1335735|NCT02000622|Other Pre-specified|Time to First Subsequent Cancer Therapy or Death (TFST)|Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death.|Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
1335746|NCT02000440|Secondary|Area Under Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) and AUC From Time Zero to the End of Dosing Period (AUC[0-tau]) of Losmapimod 7.5 mg in Plasma|Pharmacokinetics (PK) of losmapimod 7.5 mg was evaluated in participants with focal segmental glomerulosclerosis (FSGS) using AUC over the dosing interval of losmapimod 7.5 mg. PK samples were collected at Week 0 (pre-dose and 1, 2, 4, 6 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 0 (Pre-dose and 1, 2, 4, 6 hrs post-dose)|PK Population: All participants from whom a PK sample obtained and analyzed, included in the PK population.||||||
1335736|NCT02000622|Secondary|Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm|Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Assessed in patients with a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).|Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.|Subset of Full Analysis Set (FAS) consisting of all randomised patients who were confirmed as Myriad CDx gBRCAm|||Months||95% Confidence Interval|Median
1335737|NCT02000622|Secondary|Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)|Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL.|EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months.|Subset of Full Analysis Set (FAS) consisting of all randomised patients with an evaluable baseline EORTC QLQ-C30 assessment and at least one evaluable post-baseline assessment|||Score on a scale||95% Confidence Interval|Mean
1335738|NCT02000622|Secondary|Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)|Number of responders according to blinded independent central review (BICR) assessment. Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR.|Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.|Evaluable For Response (EFR) Analysis Set consisting of all randomised patients with measurable disease at baseline, i.e. at least one measurable target lesion assessed by blinded independent central review (BICR)|||Participants|||Number
1335739|NCT02000622|Secondary|Overall Survival (OS)|Time from randomisation until death due to any cause.|Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
1335740|NCT02000622|Secondary|Time to Second Progression or Death (PFS2)|Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination.|Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
1335741|NCT02000622|Primary|Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)|Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
1335742|NCT02000531|Secondary|Participants With Adverse Events||start of second-line treatment to data cut-off in December 2014 (within 12 months)|Safety Population, defined as all participants enrolled in this extension study|||participants|||Number
1335743|NCT02000531|Primary|Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events|Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.|within 3 years, 9 months (data cut-off December 2014)|Intention to treat population, defined as all participants enrolled in this extension study|||Months||95% Confidence Interval|Median
1335744|NCT02000440|Secondary|Plasma Losmapimod 7.5 mg Maximum Observed Concentration (Cmax)|PK of losmapimod 7.5 mg was evaluated in participants with FSGS using Cmax PK samples were collected at Week 0 (pre-dose and 1, 2, 4, 6 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 0 (Pre-dose and 1, 2, 4, 6 hrs post-dose)|PK Population.||||||
1335745|NCT02000440|Secondary|(AUC[0-tau]) of Losmapimod 15 mg in Plasma|PK of losmapimod 15 mg was evaluated in participants with FSGS using AUC over the dosing interval of losmapimod 15 mg. PK samples were collected at Week 2 (Pre-dose, 2 hrs post-dose) and Week 4, 8, 16, 24 (one of the following post-dose times: 0-2 hrs, 2-4 hrs, 4-6 hrs, and 6-8 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 2 (Pre-dose, 2 hrs post-dose) and Week 4, 8, 16, 24 (at one of the following post-dose times: 0-2 hrs, 2-4 hrs, 4-6 hrs, and 6-8 hrs post-dose)|PK Population.||||||
1335747|NCT02000440|Secondary|Percent Change From Baseline in Cystatin C at Indicated Time Points|Cystatin C was assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Percent change||Standard Deviation|Mean
1335748|NCT02000440|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at Indicated Time Points|eGFR was calculated by using the 4-variable Modification of Diet in Renal Disease (MDRD) at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population.|||milliliter/minute/1.73 square meters||Standard Deviation|Mean
1335749|NCT02000440|Secondary|Change From Baseline in Serum Creatinine at Indicated Time Points|Serum creatinine were assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Milligram per deciliter (mg/dl)||Standard Deviation|Mean
1335750|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Albumin and Total Protein at Indicated Time Points|Clinical chemistry parameters: albumin and total protein were assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Grams per liter (g/L)||Standard Deviation|Mean
1335751|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Direct Bilirubin and Total Bilirubin at Indicated Time Points|Clinical chemistry parameters: direct bilirubin and total bilirubin were assessed at Baseline (Week 0) and at Weeks 2, 4, 8, 16 24, End of studyand Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Micromoles per liter (umol/L)||Standard Deviation|Mean
1335752|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) at Indicated Time Points|Blood samples were collected at Screening (Week -4 and -2), Baseline (Week 0) and at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) to evaluate ALT, AST, AP and GGT. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||International Units/liter (IU/L)||Standard Deviation|Mean
1335753|NCT02000440|Secondary|Change From Baseline in Heart Rate at Indicated Time Points|Heart rate was measured at screening, Baseline and throughout the treatment phase (Week 24) and Follow-up phase (Week 36). Heart rate measurement was repeated if the values are calculated <50 beats per minute. (bpm) or >110 bpm after the start of dosing. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||bpm||Standard Deviation|Mean
1335754|NCT02000440|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured in a sitting position after 5 minutes rest with comfortably seated, legs uncrossed and the back and arm supported, such that the middle of the cuff on the upper arm is at the level of the right atrium and asked to remove all clothing that covered the location of cuff placement. It was recorded at Screening, Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36). Vital sign measurements were repeated if the values were < 80 mmHg or > 140 mmHg SBP and <40 mmHg or >90 mmHg for DBP. Baseline was defined as the value obtained on Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1335755|NCT02000440|Secondary|Number of Participants Withdrawn Due to Toxicities|Participants were monitored from start of the study treatment (Week 0) up to Week 36 for development of toxicity. Participants who developed toxicity during the period were to be withdrawn from the study.|From start of the study treatment (Week 0) until the Follow-up phase (Week 36)|All Subject Population|||Participants|||Number
1335756|NCT02000440|Secondary|Number of Participants Having Any Adverse Events (AEs), Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE were included in the analysis.|From start of the study treatment (Week 0) until the Follow-up phase (Week 36)|All Subject Population|||Participants|||Number
1335757|NCT02000440|Secondary|Number of Participants With Complete Proteinuria Remissions at the Indicated Time Points|Incidence of complete remissions at any time point was defined as 24 hour total protein <0.3 gram (g) per Day and maintenance of >=70 percent of Baseline eGFR throughout the treatment period. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Week 2, Week 4, Week 8, Week 16 and Week 24|Completed Treatment Population|||Participants|||Number
1335758|NCT02000440|Secondary|Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr])|Reduction in proteinuria was measured by the Up/c ratio (spot and 24 hr) at Baseline, Week 2, 4, 8, 16, 24, end of study and at Follow-up (FU) visits Week 30 and 36. Spot urine sample was provided by the participants on site. The 24 hour urine collection started with the second morning void and ended with the first morning void on the following day; generally, 24 hour urine collection was initiated the day prior to the study visit. Baseline was defined as the value obtained at Week 0. Percent change from Baseline was calculated as change from Baseline value divided by Baseline value multiplied by 100. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, Week 30 and Week 36|All Subject Population: all eligible participants who received at least one dose of investigational drug.|||Percent change||Standard Deviation|Mean
1335759|NCT02000440|Secondary|Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at Any Time During the Treatment Phase (Week 2 to Week 24)|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as responder on achieving >=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of >=70 percent of Baseline eGFR at any time during the treatment phase of the study. Reduction in proteinuria assessment at any time during the treatment phase of the study was done by utilizing a responder analysis.|Any time during the treatment phase (Week 2 to Week 24)|Completed Treatment Population|||Participants|||Number
1335760|NCT02000440|Primary|Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as a responder on achieving >=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of >=70 percent of Baseline estimated glomerular filtration rate (eGFR) at end of treatment (>=16 Weeks). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Week 2, Week 4, Week 8, Week 16 and Week 24|Completed Treatment Population: comprised of participants who had completed >=16 weeks of losmapimod treatment or who withdrew from the treatment. Participants who withdrew prior to Week 16 were considered as non-responders.|||Participants|||Number
1335761|NCT02000427|Secondary|Steady State Concentration of Blinatumomab||Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion|Participants with available serum concentration data|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1335762|NCT02000427|Secondary|Number of Participants Who Developed Anti-blinatumomab Antibodies|Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay with the electrochemiluminescence detection technology.|Day 29 of each treatment period and 30 days after the last dose|Participants with available post-baseline antibody results|||participants|||Number
1335763|NCT02000427|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.~Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?"|From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.|All participants who received an infusion of blinatumomab|||participants|||Number
1335764|NCT02000427|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who received an allogeneic HSCT while in remission (CR/CRh*) after 2 cycles of blinatumomab treatment and did not receive any additional antileukemic treatment. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive."|From the date of allogeneic HSCT until the data cut-off date of 20 May 2015; median observation time was 3.2 months.|Participants who received allogeneic HSCT and were in remission with a CR/CRh* after 2 cycles of treatment and received the transplant without receiving any additional antileukemic medication.|||percentage of participants||95% Confidence Interval|Number
1335765|NCT02000427|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who achieved remission (CR/CRh*) during the first 2 cycles of treatment and received an allogeneic HSCT.|Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months.|Participants who received an infusion of blinatumomab and had a CR/CRh* response during the first 2 cycles of treatment.|||percentage of participants||95% Confidence Interval|Number
1335766|NCT02000427|Secondary|Overall Survival|"Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up.~Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive."|From first dose of blinatumomab until the data cut-off date; median observation time was 8.8 months.|All participants who received an infusion of blinatumomab|||months||95% Confidence Interval|Median
1335767|NCT02000427|Secondary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles|"Efficacy was evaluated via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as meeting the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.~Complete remission with partial hematological recovery was defined as meeting the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Complete remission with incomplete hematologic recovery was defined as meeting all of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab|||percentage of participants||95% Confidence Interval|Number
1335768|NCT02000427|Secondary|Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab|||percentage of participants||95% Confidence Interval|Number
1335769|NCT02000427|Secondary|Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab|||percentage of participants||95% Confidence Interval|Number
1335770|NCT02000427|Secondary|Duration of CR or CRh* Response|Duration of response was measured for participants in remission (CR/CRh*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.|Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months|Participants who received an infusion of blinatumomab and with a CR or CRh* response during the first 2 treatment cycles.|||months||95% Confidence Interval|Median
1335771|NCT02000427|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment|"Bone marrow samples were evaluated for MRD remission by a central laboratory using bcr-abl fusion gene reverse transcription polymerase chain reaction (RT-PCR).~An MRD response was defined as MRD < 10^-4 measured by PCR. Participants with no post-baseline MRD assessment were considered non-responders."|Approximately 12 weeks|All participants who received an infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
1335772|NCT02000427|Primary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease~full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.~Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow~no evidence of disease~partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
1335773|NCT02000180|Secondary|Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario|"Technical skills, communication skills, and global performance assessed during an integrated scenario through the JAG DOPS tool, integrated scenario communication rating form (ISCRF), and integrated scenario global rating form (ISGRF) respectively.~The JAG DOPS tool, as previously described, will be used to assess participants on integrated scenario colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome.~The ISCRF and ISGRF are tools which measure communication skills and global performance with a standardized nurse and standardized patient during a simulated colonoscopy. These tools can have scores from 0-100, with higher scores representing better performance."|Immediate post-training and 4-6 weeks after training (delayed post-training)||||units on a scale||Standard Deviation|Mean
1335774|NCT02000180|Secondary|Colonoscopy Specific-performance.|The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants on virtual reality colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome.|Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training)||||units on a scale||Standard Deviation|Mean
1338207|NCT01965665|Primary|Number of Patients With Pin Site Infection|Patients will be assessed weekly for pin site infection up until frame removal.|weekly from baseline until frame removal, up to 16 weeks||||participants|||Number
1335776|NCT02000180|Primary|Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)|The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants before and after the intervention at a time of one week. A change in these ratings before and after intervention is the primary outcome.|4-6 weeks post-intervention||||units on a scale||Standard Deviation|Mean
1335777|NCT02000154|Secondary|Cytogenetic Response|"NCA (not considered assessable)~no evidence of cytogenetic response, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome."|Up to 20 weeks||||participants|||Number
1335778|NCT02000154|Secondary|Hematologic Improvement|"NCA (not considered assessable)~no evidence of hematologic improvement -erythroid, -platelet, -neutrophil, progressive disease, or relapse, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome."|Up to 20 weeks||||participants|||Number
1335779|NCT02000154|Secondary|Serious Adverse Events|Total number affected any serious adverse events|Up to 20 weeks||||participants|||Number
1335780|NCT02000154|Secondary|Disease Response Assessment|"Disease progression~According to the International Working Group 2006 response criteria for Myelodysplastic Syndrome, disease progression is defined as no evidence of complete remission (CR), partial remission, marrow CR, stable disease, or failure, and as meeting one of the following conditions.~when pretreatment percentage of bone marrow blasts < 5%: ≥ 50% increase to > 5%.~when pretreatment percentage of bone marrow blasts 5 to 10%: ≥ 50% increase to > 10%.~when pretreatment percentage of bone marrow blasts 10 to 20%: ≥ 50% increase to > 20%.~when pretreatment percentage of bone marrow blasts 20 to 30%: ≥ 50% increase to > 30%.~other: at least one of the following: decrease to ≤ 50% of neutrophil or platelet count at maximum response, ≥ 2 g/dL decrease in Hgb or transfusion dependence (in the absence of other factors, such as infection, gastrointestinal bleeding, or hemolysis)."|Up to 20 weeks||||participants|||Number
1335781|NCT02000154|Primary|Adverse Events|Total number affected by any adverse events (details are presented in adverse event section)|Up to 20 weeks||||participants|||Number
1335782|NCT01999920|Secondary|Change From Baseline on Adult Separation Anxiety - 27 Scale|Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
1335783|NCT01999920|Secondary|Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder|The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don’t recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as ‘2’ or ‘often’) is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0–16).|Baseline and week 12||||units on a scale||Standard Deviation|Mean
1335784|NCT01999920|Secondary|Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire|Measure Description: (10 min) Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
1335785|NCT01999920|Secondary|Change From Baseline in Attachment Style Questionnaire Score|Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
1335786|NCT01999920|Secondary|Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score|This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
1335787|NCT01999920|Primary|Clinical Global Impression-Improvement Scale|"Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). Responder is a score of 1 or 2."|Up to 12 weeks||||Participants|||Count of Participants
1335788|NCT01999894|Primary|Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)|Number of patients who experienced one or more TEAEs during the study|From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)|The Safety Population consists of 102 enrolled patients who received at least one dose of study drug.|||participants|||Number
1335789|NCT01999400|Secondary|The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum|The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.|0 hours pre-dose and up to 7 hours post-dose|The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.|||uM*h||Standard Deviation|Mean
1335790|NCT01999400|Secondary|The AUC of Mesalamine in Distal Jejunum|The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.|0 hours pre-dose and up to 7 hours post-dose|The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.|||uM*h||Standard Deviation|Mean
1335791|NCT01999400|Primary|The AUC of Metabolite (N-acetyl-mesalamine) in Plasma|The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of N-acetyl-mesalamine per liter of plasma (nM) multiplied by time in hours (nM*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.|0 hours pre-dose and up to 96 hours post-dose||||nM*h||Standard Deviation|Mean
1335792|NCT01999400|Primary|The AUC of Mesalamine in Plasma|The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of mesalamine per liter of plasma (nM) multiplied by time in hours (nM*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.|0 hours pre-dose and up to 96 hours post-dose||||nM*h||Standard Deviation|Mean
1335793|NCT01999348|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment.|||participants|||Number
1335794|NCT01999348|Secondary|Percentage of Patients Prescribed by the Physician to Continue Treatment|The percentage of participants who continued treatment with Ganfort® UD after Week 12.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||percentage of participants|||Number
1335795|NCT01999348|Secondary|Percentage of Patients Who Discontinued Treatment|The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit|12 Weeks|Per-protocol population included all treated participants who had no major protocol violations.|||percentage of participants|||Number
1335796|NCT01999348|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|The physician assessed the patient’s tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||participants|||Number
1335797|NCT01999348|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||participants|||Number
1335798|NCT01999348|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale|The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.|Baseline, Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||participants|||Number
1335799|NCT01999348|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).|Baseline, Final Visit (Week 8 to 12)|Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses.|||mmHg||Standard Deviation|Mean
1335800|NCT01999322|Secondary|Number of Premature Infusion Set Changes|"A premature infusion set change was defined as not being a routine change. This was defined as an infusion set changed at home due to suspicion of occlusion, leakage, unexplained hyperglycaemic episode, infusion site reaction, technical reason, or other. The change of infusion set at a site visit was considered a routine change unless an occlusion was actually suspected at the site."|During 6 weeks of treatment||||Episodes|||Number
1335801|NCT01999322|Secondary|Number of Episodes of Possible Infusion Set Occlusions|Episodes of possible infusion set occlusions were defined as infusion sets changed due to suspicion of occlusion, leakage or unexplained hyperglycaemic episode. Possible occlusion excluded technical reasons. This endpoint was calculated from the recorded date/times of changes of infusion set combined with the subjects’ own assessment.|During 6 weeks of treatment||||Episodes|||Number
1335802|NCT01999322|Secondary|Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))|Unexplained hyperglycaemia was defined as a confirmed plasma glucose value ≥ 16.7 mmol/L (300 mg/dL) and was unexplained (i.e., no apparent medical, dietary, insulin dosage or pump failure reason)|During 6 weeks of treatment||||events|||Number
1335840|NCT01998906|Primary|Percentage of Participants Event Free at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
1338208|NCT01965665|Primary|Total Number of Pin Sites|total number of pin sites for all patients enrolled|Day of surgical intervention approximately 3hrs.||||total number of pin sites|||Number
1335803|NCT01999322|Primary|Number of Microscopically Confirmed Episodes of Infusion Set Occlusions|The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug).|During 6 weeks of treatment|FAS: included all randomised subjects. In exceptional cases subjects could be excluded from the full analysis set. In such cases the reason for exclusion was to be justified and documented. Subjects in the full analysis set contribute to the evaluation “as randomised”.|||Episodes|||Number
1335804|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 96h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|96h after application of ESAT6-CFP10||||participants|||Number
1335805|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 72h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|72h after application of ESAT6-CFP10||||participants|||Number
1335806|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 48h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|48h after application of ESAT6-CFP10||||participants|||Number
1335807|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 24h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|24h after application of ESAT6-CFP10||||participants|||Number
1335808|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 2h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|within 2h after application of ESAT6-CFP10|Induration and/or redness is our main immune response of ESAT6-CFP10.|||participants|||Number
1335809|NCT01999231|Primary|the Cases of Adverse Events With Participant Injection of ESAT6-CFP10|The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .|within 7 days after the injections|ESAT6-CFP10 allergen similar to TB-PPD(Tuberculin purified protein derivative ), main ingredients are protein and can cause specific skin allergy in the injection site ( such as redness, swelling, induration, blisters), besides other local reactions, is still listed as adverse events .|||cases|||Number
1335810|NCT01999218|Secondary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach|This change from baseline reflects the Week 52 SBP minus the Week 0 SBP. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.|Baseline and Week 52|All randomized, treated participants with at least one SBP measurement (baseline or a post-baseline).|||mmHg||95% Confidence Interval|Least Squares Mean
1335811|NCT01999218|Secondary|Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach|This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.|Baseline and Week 52|All randomized, treated participants with at least one body weight measurement (baseline or a post-baseline).|||Kilograms||95% Confidence Interval|Least Squares Mean
1335812|NCT01999218|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach|Symptomatic hypoglycemia was an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required). Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.|Up to Week 52|All randomized participants who took at least one dose of trial treatment.|||Percentage of Participants|||Number
1335813|NCT01999218|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 104|All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.|||Percentage of Participants|||Number
1335814|NCT01999218|Primary|Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 106|All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.|||Percentage of Participants|||Number
1335900|NCT01998360|Secondary|Cosmetic Result|"Regular: scar line straight without any irregularity~Irregular: Some irregularity to scar line~Scalloped: wavy appearane to scar line"|6 weeks||||participants|||Number
1335815|NCT01999218|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.|Baseline and Week 52|All randomized, treated participants with at least one A1C measurement (baseline or a post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
1335816|NCT01999192|Other Pre-specified|Evaluation of Safety, Patient Reported Outcomes & Blood Tests.||up to 48 weeks|||||||
1335817|NCT01999192|Other Pre-specified|Pharmacokinetics|AUC, Cmax, Tmax at baseline, and at Week (W) 2/Visit (V) 4, W4/V5, W8/V7, W12/V8, W24/V10, W3/V122, W48 (end of Treatment [EoT]/ early termination ET), and at follow-up (post EoT/post ET).|up to 48 weeks|||||||
1335818|NCT01999192|Secondary|DAS28 Score Individual Components||up to 48 weeks|||||||
1335819|NCT01999192|Secondary|ACR Score Individual Components||up to 48 weeks|||||||
1335820|NCT01999192|Secondary|EULAR Response||up to 48 weeks|||||||
1335821|NCT01999192|Secondary|DAS28||up to 48 weeks|||||||
1335822|NCT01999192|Secondary|Clinical Disease Activity Index [CDAI] ≤10||week 12 & 24|||||||
1335823|NCT01999192|Secondary|Simple Disease Activity Index [SDAI] ≤11||week 12 & 24|||||||
1335824|NCT01999192|Secondary|ACR Score||up to 48 weeks|||||||
1335825|NCT01999192|Secondary|Proportions of Subjects With Low Disease Activity DAS28 ≤3.2||Week 12 & Week 24|||||||
1335826|NCT01999192|Secondary|Proportions of Subjects With an Disease Activity Score DAS28 <2.6||Week 12 & Week 24|||||||
1335827|NCT01999192|Secondary|Proportions of Subjects With an ACR 50 & 70 Response.||Week 12 & Week 24|||||||
1335828|NCT01999192|Secondary|Proportions of Subjects With an ACR 20 Response.||Week 24|||||||
1335829|NCT01999192|Primary|The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX|"The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.~The analysis of the primary endpoint was performed using observed cases (OC) on the FAS."|Week 12|"The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.~Full analysis set (FAS): All subjects entered into the study who received at least one dose of study medication and have at least one post-baseline assessment."|||percentage of Subjects|||Number
1335830|NCT01998919|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Date of randomization until date of death or date of last follow-up assessment|FAS Population|||weeks||95% Confidence Interval|Median
1335831|NCT01998919|Secondary|Progression-Free Survival (PFS)|PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population|||weeks||95% Confidence Interval|Median
1335832|NCT01998919|Secondary|Time to Progression|Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population|||weeks||95% Confidence Interval|Median
1335833|NCT01998919|Secondary|Duration of Response|Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases|FAS; only participants with CR or PR were included in the analysis.|||weeks||95% Confidence Interval|Median
1335834|NCT01998919|Secondary|Percentage of Participants With Confirmed CR or PR as Assessed by RECIST|CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS|||percentage of participants||95% Confidence Interval|Number
1335835|NCT01998919|Secondary|Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST|Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.|Week 16|FAS|||percentage of participants||95% Confidence Interval|Number
1335836|NCT01998919|Primary|Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.|Week 8|FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.|||percentage of participants||95% Confidence Interval|Number
1335837|NCT01998906|Secondary|Percentage of Participants Surviving at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
1335841|NCT01998906|Secondary|Percentage of Participants Surviving at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
1335842|NCT01998906|Secondary|Overall Survival|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||months||95% Confidence Interval|Median
1335843|NCT01998906|Primary|Percentage of Participants Event Free at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
1335844|NCT01998906|Primary|Event-Free Survival|The median time, in months, between randomization and date of documented occurrence of an EFS event.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||months||95% Confidence Interval|Median
1335845|NCT01998906|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants|||Number
1335846|NCT01998906|Secondary|Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.|BL, Presurgery: Day 1 of Cycles 1-10|FAS|||percentage of participants||95% Confidence Interval|Number
1335847|NCT01998906|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS|||percentage of participants||95% Confidence Interval|Number
1335848|NCT01998906|Secondary|Percentage of Participants With Breast Pathological Complete Response (bpCR)|bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS|||percentage of participants||95% Confidence Interval|Number
1335849|NCT01998906|Primary|Event-Free Survival (EFS) - Percentage of Participants With an Event|EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.|Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm.|||percentage of participants|||Number
1335850|NCT01998893|Secondary|Number of Participants With a Clinical Response to Re-Treatment|Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).|Participants in the ITT population who began a second cycle of treatment.|||participants|||Number
1335851|NCT01998893|Secondary|Overall Survival (OS)|OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||months||95% Confidence Interval|Median
1335852|NCT01998893|Secondary|Time to Progression|The median time, in months, from the start of treatment (first application) until detection of PD.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||months||95% Confidence Interval|Median
1335853|NCT01998893|Secondary|Duration of Remission|Median time, in months, between the documentation of CR or PR and PD in clinical responders.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|Participants in the ITT population with CR or PR after the first treatment cycle.|||months||95% Confidence Interval|Median
1335854|NCT01998893|Secondary|Time to Best Response|The median time, in months, from start of the treatment (first application) until best response (PR or CR).|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population; only participants with at least one application of study treatment within the first 4 weeks of treatment were included in the analysis.|||months||95% Confidence Interval|Median
1340471|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335855|NCT01998893|Secondary|Number of Participants With a Clinical Response|Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||participants|||Number
1335856|NCT01998893|Primary|Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)|Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||percentage of participants||95% Confidence Interval|Number
1335857|NCT01998880|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 CLL cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 15.2 months)|Participants from the Intent-to-treat population (all randomized participants) with MRD data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
1335858|NCT01998880|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 15.2 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
1335859|NCT01998880|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.|||Months||95% Confidence Interval|Median
1335860|NCT01998880|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.|||Months||95% Confidence Interval|Median
1335861|NCT01998880|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1335862|NCT01998880|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 15.2 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.|||Months||95% Confidence Interval|Median
1335863|NCT01998737|Secondary|Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis|The previously determined thresholds have been applied. The results show amount of subject whose DI value is between the thresholds. These subjects would need DXA measurement to verify diagnosis.|3 years||||Participants|||Count of Participants
1335864|NCT01998737|Primary|Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis|The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.|3 years||||percentage of true negatives|||Number
1335865|NCT01998737|Primary|Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis|The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.|3 years||||percentage of true positives|||Number
1335866|NCT01998633|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
1335867|NCT01998633|Secondary|Number of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe.|1 year post-transplant||||Participants|||Count of Participants
1335868|NCT01998633|Secondary|Percentage of Participants With Grade II-IV and Grade III-IV Acute GVHD|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 100 and 6 months post-transplant||||percentage of participants||95% Confidence Interval|Number
1335869|NCT01998633|Secondary|Number of Participants With Acute Graft-Versus-Host Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|1 year post-transplant||||Participants|||Count of Participants
1335870|NCT01998633|Secondary|Percentage of Participants Alive With Sustained Engraftment by Disease Type|Sustained engraftment is defined as the occurrence of whole blood donor chimerism > 5% by Day 42 accompanied by the absence of any primary or secondary graft failure. Primary graft failure is defined as < 5% donor chimerism by Day +42, second stem cell infusion, DLI (except in the case of donor CTLs given for infection control), or second HCT following original HCT. Secondary graft failure is defined as < 5% donor chimerism following initial engraftment.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
1335871|NCT01998633|Secondary|Percentage of Participants Alive With Sustained Engraftment|Sustained engraftment is defined as the occurrence of whole blood donor chimerism > 5% by Day 42 accompanied by the absence of any primary or secondary graft failure. Primary graft failure is defined as < 5% donor chimerism by Day +42, second stem cell infusion, DLI (except in the case of donor CTLs given for infection control), or second HCT following original HCT. Secondary graft failure is defined as < 5% donor chimerism following initial engraftment.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
1335872|NCT01998633|Secondary|Percentage of Participants With Platelet Engraftment|Platelet engraftment is defined as the first day of a minimum of three measurements on different days that the patient has achieved a platelet count > 20,000 / microliter AND the patient is platelet transfusion independent for a minimum of seven days following conditioning regimen induced nadir.|Day 100 post-transplant||||percentage of participants||95% Confidence Interval|Number
1335873|NCT01998633|Secondary|Percentage of Participants With Neutrophil Engraftment|Time to absolute neutrophil count (ANC) engraftment is defined as the first of three measurements on different days that the patient has an absolute neutrophil count of ≥ 500x10^6/liter following conditioning regimen induced nadir.|Day 42 post-transplant||||percentage of participants||95% Confidence Interval|Number
1335874|NCT01998633|Secondary|Percentage of HLH Participants With HLH Reactivation Post-Transplant|"Systemic HLH Reactivation: Post-transplant HLH reactivation is defined by clinical and lab evidence of pathologic inflammation (persistent fever, progressive cytopenias, rising ferritin and soluble IL2Rα, decreasing fibrinogen, hepatosplenomegaly, end-organ damage) not attributable to other causes.~Central nervous system (CNS) HLH Reactivation: Reactivation of CNS inflammation in patients with HLH may present with or without altered mental status and is defined by pleocytosis in Cerebrospinal fluid (CSF) or an MRI consistent with CNS inflammation not attributable to other causes."|1 year post-transplant|Participants with HLH|||percentage of participants||95% Confidence Interval|Number
1335875|NCT01998633|Secondary|Percentage of Participants With Overall Survival (OS) by Disease Type|Overall survival is defined as survival of death from any cause.|1 year and 18 months post-transplant||||percentage of participants||95% Confidence Interval|Number
1335876|NCT01998633|Primary|Percentage of Participants With Overall Survival (OS)|Overall survival is defined as survival of death from any cause.|1 year and 18 months post-transplant||||percentage of participants||95% Confidence Interval|Number
1340472|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1335877|NCT01998581|Secondary|Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire|Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with data at both time points and received at least 1 treatment|||Scores on a Scale||95% Confidence Interval|Mean
1335878|NCT01998581|Secondary|Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only.|Baseline, Month 3|Subjects in the JUVEDERM VOLBELLA® XC group who received treatment in perioral lines with a baseline POLSS score of moderate or severe|||Percentage of Subjects||95% Confidence Interval|Number
1335879|NCT01998581|Primary|Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale|Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with a Lip Fullness Scale 2 baseline score of minimal, mild, or moderate and who received at least 1 treatment|||Scores on a Scale||Standard Deviation|Mean
1335880|NCT01998477|Primary|Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata|Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years)|Day 1 –Day 181(one dose group) Day 1 –Day 209(two dose group)|Analysis was done on unsolicited safety dataset, i.e. all subjects in the Exposed Set who have post-vaccination unsolicited AE records (even if no AEs have occurred)|||Subjects|||Number
1335881|NCT01998477|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata|Safety was assessed in terms of number of the subjects (3 to <6 years,(≥ 6 to < 9 years and 9 to <18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV|Day 1 through Day 7 after any vaccination|Analysis was done on safety dataset|||Subjects|||Number
1335882|NCT01998477|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group|Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV|Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2|Analysis was done on safety dataset, i.e. the subjects in the Exposed Set who provided post-vaccination solicited AE data|||Subjects|||Number
1335883|NCT01998438|Other Pre-specified|Rate of Reexploration for Bleeding||on the 7th day postoperatively|||||||
1335884|NCT01998438|Secondary|Number of Participants Needs Allogenic Transfusion||on the 7th day postoperatively|||||||
1335885|NCT01998438|Primary|Postoperative Blood Loss||24hrs postoperatively||||ml||Inter-Quartile Range|Median
1335886|NCT01998399|Other Pre-specified|Discharge Disposition|(Home, other facility, with or without assisted ventilation)|90 days||||Participants|||Count of Participants
1335887|NCT01998399|Other Pre-specified|Hospital Length of Stay|In days|29 days||||days||Full Range|Mean
1335888|NCT01998399|Other Pre-specified|ICU Length of Stay|Includes ICU readmission if during same hospital stay|29 days|2 participants from each arm died during this period|||days||Full Range|Mean
1335889|NCT01998399|Other Pre-specified|Need for Dialysis||28 days||||Participants|||Count of Participants
1335890|NCT01998399|Other Pre-specified|Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support)||90 days|only participants that required mechanical ventilation|||Participants|||Count of Participants
1335891|NCT01998399|Other Pre-specified|Time to Initiation of Unassisted Breathing|Only in patients on mechanical ventilation and assuming patient achieves 48 consecutive hours of unassisted breathing|29 days|2 participants from each arm died during this period|||hours||Full Range|Mean
1335892|NCT01998399|Secondary|Myocardial Infarction|Did the patient have a myocardial infarction during the 90 day study?|90 days||||Participants|||Count of Participants
1335893|NCT01998399|Secondary|Stroke, Myocardial Infarct, Mortality|number of participants that suffered stroke, myocardial infarct, mortality|90 days||||Participants|||Count of Participants
1335894|NCT01998399|Secondary|Stroke|Did the patient develop a stroke during the 90 day study?|90 days||||Participants|||Count of Participants
1335895|NCT01998399|Secondary|Hospital Free Days|Number of days the patient is not in the hospital|29 days|2 participants from each group died during this time period|||days||Full Range|Mean
1335896|NCT01998399|Secondary|In-hospital Mortality|Did the patient die during the hospitalization?|Throughout hospitalization (About 2 weeks)||||Participants|||Count of Participants
1335897|NCT01998399|Secondary|Ventilator Free Days||29 days|2 participants from each arm died during the 29 day period|||days||Full Range|Mean
1335898|NCT01998399|Secondary|Shock Free Days|Not requiring pressor support for hypotension|15 days|2 participants from the Ticagrelor arm and 1 from the placebo arm died during the 15 day period|||days||Full Range|Mean
1335899|NCT01998399|Primary|All-cause Mortality|death during 90 day study period|90 days||||participants|||Number
1335905|NCT01998269|Primary|Measure of Medication Self-Management (MeDS)|The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.|cross-sectional, 1 hour interview after clinic visit||||units on a scale||Standard Deviation|Mean
1335906|NCT01997905|Secondary|Overall Adverse Event Rate|Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure|All treated patients.|||participants|||Number
1335907|NCT01997905|Secondary|Overall Serious Adverse Event Rate|Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month Post Index Procedure|All treated patients.|||participants|||Number
1335908|NCT01997905|Secondary|Serious Device or Procedure Related Adverse Event Rate|Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure||||participants|||Number
1335909|NCT01997905|Secondary|Rate of Stroke and Non-CNS Systemic Embolism|"The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure:~Stroke (ischemic )~Non-CNS (Central Nervous System) systemic embolism."|3 months and 6 months post-index procedure||||participants|||Number
1335910|NCT01997905|Primary|Composite Left Atrial Appendage Placement and Exclusion Success|"Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:~Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.~Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and <10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE.~3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and < 10mm residual pocket) between the LA and LAA at >=3 month TEE or CTA evaluation."|Immediate to 3-months post-index procedure|Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient.|||participants|||Number
1335911|NCT01997905|Primary|Number of Serious Adverse Events Within 30 Days Post-Index Procedure|"The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator:~Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip~Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke~Major bleeding (defined as requiring re-operation and/or transfusion (> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure)."|30 days post-index procedure||||participants|||Number
1335912|NCT01997892|Secondary|Percentage of Participants With Hemoglobin Excursions|The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods.|Month -3, -2, -1, 1, 2, 3, 4, 5 and 6|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1335913|NCT01997892|Secondary|Hemoglobin Concentration Rate of Change by Period|The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant.|Thre months prior to switch and 6 months after the switch|Primary Analysis Set with available data|||g/dL/4 week||Standard Deviation|Mean
1335914|NCT01997892|Secondary|Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa|Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (μg darbepoetin alfa per 1 μg pegylated-epoetin beta).|Week -1 and Week 1|Primary analysis set|||ratio||95% Confidence Interval|Geometric Mean
1335915|NCT01997892|Secondary|Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month 1, 2, 3, 4, 5 and 6|"Primary analysis set; participants with available data at each time point (as indicated by n)."|||μg/week||95% Confidence Interval|Geometric Mean
1335916|NCT01997892|Secondary|PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month -3, Month -2, Month -1|"Primary analysis set; participants with available data at each time point (indicated by n)."|||μg/week||95% Confidence Interval|Geometric Mean
1335917|NCT01997892|Primary|Hemoglobin Concentration at Monthly Intervals|Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.|Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)|"Primary analysis set; participants with available data at each time point (indicated by n)."|||g/dL||Standard Deviation|Mean
1335919|NCT01997723|Secondary|Technical Failure Rate|home PM tests that failed to provide technically adequate data for diagnosis. Technical failure(s) were tests where estimated total sleep time (TST) was ≤ 2 hours or portable monitor data of interpretable quality was less than 4 hours per recording.|4 days||||percentage of recordings|||Number
1335920|NCT01997723|Primary|Apnea Hypopnea Index (AHI)|"AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep.~AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG)."|4 days|The polysomnography area under the curve (AUC) in an ROC plot for this study was assumed to be 0.99. The AUC for home PM test was targeted at 0.88 based on published report for power of 0.90 in a population with estimated pretest probability of 75-85%, ascertained by Berlin Questionnaire.|||events per hour||Standard Deviation|Mean
1335921|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|6 months postoperative|||||||
1335922|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|3 months postoperative|||||||
1335923|NCT01997567|Secondary|Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|Preoperative 2-8 wks|||||||
1335924|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|6 months postoperative|||||||
1335925|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|3 months postoperative|||||||
1335926|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|3 wks postoperative|||||||
1335927|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|Preoperative 2-8 wks|||||||
1335928|NCT01997437|Primary|Number of Mononuclear Cells (MNCs) Per ml|MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.|1 time before seeding on scaffold||||MNCs per ml||Standard Error|Mean
1335929|NCT01997437|Secondary|Number of Disease Free Survival Patients|The disease free survival of patient were evaluated after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up||||participants|||Number
1335930|NCT01997437|Secondary|Number of Survival Patients|To evaluate the survival of patient after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up||||participants|||Number
1335931|NCT01997437|Primary|Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold|Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up|12 months post operative follow up||||participants|||Number
1335932|NCT01997411|Other Pre-specified|Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes||Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||percentage of participants|||Number
1335933|NCT01997411|Secondary|Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes|Time (in minutes) when all participants experienced a rise in glucose >=25mg/dL. This is an absolute number and is not a calculated statistic. There is no distribution per cohort.|Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||minutes|||Number
1335934|NCT01997411|Secondary|Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes||Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||Participants|||Count of Participants
1335935|NCT01997411|Secondary|Nasal and Non-nasal Effects/Symptoms|"Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed prior to administering glucagon and at 15, 30, 60 and 90 minutes following administration of glucagon. This was done via the Nasal Non-nasal Score Questionnaire. Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each participant and reporting the median/IQR across participants)."|Pre-dose;15, 30, 60 and 90 minutes following glucagon administration|All enrolled participants. One participant in the 8 to <12 group withdrew from the study after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||units on a scale||Inter-Quartile Range|Median
1335936|NCT01997411|Primary|Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hr*mg/dL||Standard Deviation|Mean
1335937|NCT01997411|Primary|Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hours (hr)||Full Range|Median
1335938|NCT01997411|Primary|Maximum Concentration (Cmax) of Baseline-Adjusted Glucose||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||mg/dL||Standard Deviation|Mean
1335939|NCT01997411|Primary|Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hour*picogram per millilitre (hr*pg/mL)||Standard Deviation|Mean
1335940|NCT01997411|Primary|Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hours (hr)||Full Range|Median
1335941|NCT01997411|Primary|Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
1335942|NCT01997398|Secondary|Parkinson's Disease Quality-39 Score (PDQ-39)|"Effects on PDQ-39 scores 6 months following asleep DBS surgery as compared to pre-operative scores. Data from the PDQ-39 can be presented either subset scores or as a single total score. PDQ-39 measures patient quality of life indicators including mobility, activities of daily living, emotional well being, stigma, communication and bodily discomfort. Data from the PDQ-39 can be presented in either subset scores or as a single total score. The full range of the total PDQ-39 scores is from 0 ( no patient related symptoms, or quality of life unaffected) to 156 ( relates having symptoms , or low quality of life).~The subset score ranges are as follows:~mobility: 0 (no patient related symptoms) to 40 (highest patient related symptoms). activities of daily living: 0 to 24; emotional well being: 0-24; stigma: 0-16; cognition: 0-16; communication: 0-12; bodily discomfort: 0-12."|pre-operatively and 6 months post-operatively||||units on a scale||Standard Deviation|Mean
1335943|NCT01997398|Primary|"Off and On Medication Unified Parkinson's Disease Rating III Score (UPDRS)"|"A movement disorders clinician who had completed the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) training performed prospective baseline and 6-month postoperative assessments of motor function using the MDS modified UPDRS III on patients during both off-medication (PD medications held for 12 h) and on-medication states.~UPDRS III motor scores range from 0 (no motor function deficit) to 132 (highest motor function deficit). There were no subscales."|pre-operatively and 6 months post-operatively||||units on a scale||Standard Deviation|Mean
1335944|NCT01997229|Primary|Myasthenia Gravis Activities of Daily Living Profile (MG-ADL): Change From Baseline in MG-ADL Total Score at Week 26 by Worst-Rank Analysis of Covariance (ANCOVA)|In the Worst-Rank analysis, the 125 total patients were ranked from best outcome (rank/score of 1) to worst outcome (rank/score of 125).|End of study (Week 26)||||scores on a scale||Standard Error|Least Squares Mean
1335945|NCT01997216|Secondary|Mean Monocular Over-refraction (OR) at Distance|OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.|Up to Hour 9|All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability.|||diopter||Standard Deviation|Mean
1335946|NCT01997216|Secondary|Mean Binocular HC/HI Visual Acuity at Distance|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.|||logMAR||Standard Deviation|Mean
1335947|NCT01997216|Primary|Mean Binocular HC/HI Visual Acuity at Near (40 cm)|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.|||logMAR||Standard Deviation|Mean
1335948|NCT01996904|Secondary|Ultrasound Diagnosis|US is a diagnostic imaging technique used to visualise deep structures of the body by recording the echoes of pulsed ultrasonic waves directed into the tissues and reflected by tissue planes to the transducer. These echoes are converted into 'pictures' of the tissues under examination. It consists of a non-invasive examination that has practically no adverse effects and allows dynamic visualisation of the tendons during movement of the shoulder.|every three months after the surgery until the 24th month|||||||
1340588|NCT01937520|Primary|Pain Levels|Visual Acuity scale 0=no pain 10= worst pain possible|PACU, day 1 , day 2, day 3|female patients self reported pain experience following surgery|||units on a scale||Standard Error|Mean
1335949|NCT01996904|Primary|ASES Score|The ASES is a 100-point scale which is divided in two sections. Fifty points of which are derived from patient self-report of pain and the other 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living .The item related to pain is evaluated by a VAS (10 cm) that ranges from 0 (no pain at all) to 10 (pain as bad as it can be). The ten activities of daily living include skills such as putting on a coat, sleeping on the affected side, wash back/do up bra in back, manage toileting, combing one's hair, reach a high shelf, lift 10lbs above shoulder,throw a ball overhand,do usual work and do usual sport.The items related to function are evaluated by a four-point Likert scale. The scores of the pain and function subsections are transformed in percentages and each one represents 50% of the final score, which can range from 0 (absence of function) to 100 (normal function).|24th month||||units on a scale||Standard Deviation|Mean
1335950|NCT01996813|Secondary|Operation Time|The length of operation time (in minutes) is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.|End of surgery|The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.|||Minutes||Standard Deviation|Median
1335951|NCT01996813|Primary|Cerebral Desaturation Event|The prevalence of a cerebral desaturation event is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.|Assessed intraoperatively, an average of 114 minutes|The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.|||Participants|||Count of Participants
1335952|NCT01996748|Secondary|Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1).|"Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 15 compared to baseline).~Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe."|Baseline and day 15||||units on a scale||Standard Deviation|Mean
1335953|NCT01996748|Secondary|Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1).|"Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 8 compared to baseline).~Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe."|Baseline and day 8||||units on a scale||Standard Deviation|Mean
1335954|NCT01996748|Secondary|Change in Signs/ Symptoms|- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).|Baseline and days 9-15||||units on a scale||Standard Deviation|Mean
1335955|NCT01996748|Primary|Analysis of the Itching Change at the End of Treatment.|The analysis of the itching change at the end of treatment (mean itching on days 4-8 compared to baseline). Itching was assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe|Baseline and days 4-8||||units on a scale||Standard Deviation|Mean
1335956|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Dryness at Day 90|"As reported and interpreted by the subject on a questionnaire. The subject was asked During a typical day in the past 2 weeks, how often did your eyes feel dry? and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly)."|Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1335957|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Grittiness at Day 90|"As interpreted and reported by the subject on a questionnaire. The subject was asked, During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses? and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly)."|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||units on a scale||Standard Deviation|Mean
1335958|NCT01996709|Secondary|"Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90"|As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||percentage of subjects|||Number
1335959|NCT01996709|Primary|Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90|Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.|Baseline (Day 0), Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1335960|NCT01996657|Secondary|All Cause Deaths|The deaths from all causes|Up to 24 months||||Participants|||Count of Participants
1335961|NCT01996657|Primary|Thrombotic Events|The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.|24 months||||Participants|||Count of Participants
1335962|NCT01996657|Primary|Bleeding Events;|The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.|Up to 24 months||||Participants|||Count of Participants
1335963|NCT01996644|Other Pre-specified|Fear of Food Measure|"The Fear of Food Measure (FOFM) was designed to assess three cognitive behavioral components related to mealtime anxiety. All items are rated on a 1 to 7 Likert-type scale ranging from not at all to “very much so.” Higher values indicate worse outcomes. The first subscale is the anxiety about eating subscale, which was designed to assess trait levels of fear and anxiety surrounding eating and food. This subscale will be measured once before and after the trial (twice in 2 weeks). Each item (8 items totaled, each scored 1-7; max possible score is 56; min possible score is 8) was added for each time point and time points were averaged together for all participants for both time points."|Twice during 2 weeks|All combined represents the total number of participants (n=40); however 4 participants withdrew. Analysis utilized data for 36 participants who started in participant flow, thus (n=36).|||Units on a scale||Standard Deviation|Mean
1335964|NCT01996644|Primary|Body Mass Index|BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome.|twice a week for two weeks and at initial assessment||||kg/m^2||Standard Deviation|Mean
1335965|NCT01996644|Primary|Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).|"Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition.~Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced."|Twice a week for two weeks||||Units on a scale||Standard Deviation|Mean
1335966|NCT01996592|Primary|Persistent Pain-EMOTIONAL DISTRESS|"By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery.~PROMIS Emotional Distress-Depression Short form utilized for this outcome. scoring for this ranges from 8-40, with the higher the score the worse the distress"|60 days||||units on a scale||Standard Deviation|Mean
1335967|NCT01996592|Primary|Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery|"By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery."|60 days||||units on a scale||Standard Deviation|Mean
1335968|NCT01996410|Primary|MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment|"The investigators will first plot M.D. Anderson Symptom Inventory Core Items (MDASI) scores over time for the acupuncture and control groups to visually inspect for differences between the two groups. The investigators will further evaluate the difference in MDASI scores for the two groups using linear mixed models that account for multiple measurements within a single patient. A mixed model is preferable to a repeated measures ANOVA in this case, as it allows for missing time points within a single subject without eliminating that subject from the analysis.~Additionally, the investigators are able to specify how our time points are correlated within patients rather than assuming equal correlation across time points. The MDASI is comprised of 13 separate items that are not summative; therefore, the significance level for all statistical tests will be set at 0.003 (0.05/13) to account for multiple comparisons."|15 months|Per IRB guidelines, we were not permitted to analyze the 10 patients enrolled since we did not meet completed enrollment numbers.||||||
1335969|NCT01996332|Secondary|Overall Survival (OS) by Line of Treatment|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date [if death date was unavailable] minus the date of first dose of study medication plus 1 divided by 30.44).|Baseline, every 6-8 weeks up to 3 years, or until death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line|||months||95% Confidence Interval|Median
1335970|NCT01996332|Secondary|Percentage of Participants Achieving Clinical Benefit by Line of Treatment|Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response [CR], partial response [PR], or stable disease [SD]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.|Baseline, every 6-8 weeks up to 3 years or until death|Response evaluable population: participants with measurable disease and with matching criteria to have a response assessment; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line|||percentage of participants||95% Confidence Interval|Number
1335971|NCT01996332|Primary|Time to Disease Progression or Death by Line of Treatment|Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.|Baseline, every 6-8 weeks up to 3 years until disease progression or death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line|||months||95% Confidence Interval|Median
1335972|NCT01996319|Secondary|Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period|||Liters||Standard Deviation|Mean
1335973|NCT01996319|Secondary|Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period|||Liters||Standard Deviation|Mean
1335974|NCT01996319|Secondary|Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 20 post treatment initiation were included in this analysis.|||Liters||Standard Deviation|Mean
1335975|NCT01996319|Secondary|Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 1 post treatment initiation were included in this analysis.|||Liters||Standard Deviation|Mean
1335976|NCT01996319|Secondary|Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo|Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22, plus baseline day 36 and day 57 data were included in this analysis.|||Minutes||Standard Deviation|Mean
1335977|NCT01996319|Secondary|Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day|The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day 1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis|||Steps/day||Standard Deviation|Mean
1335978|NCT01996319|Primary|Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level|Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis.|||kcal/day||95% Confidence Interval|Least Squares Mean
1335979|NCT01996319|Primary|Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted – so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available.|||Liters||95% Confidence Interval|Least Squares Mean
1335987|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1335980|NCT01995513|Other Pre-specified|Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
1335981|NCT01995513|Other Pre-specified|Percentage of Participants With Adverse Events (AEs) Leading to Death|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: ‘Is the AE leading to study discontinuation or death?’ as ‘yes’.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
1335982|NCT01995513|Other Pre-specified|Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: ‘Is the AE leading to study discontinuation or death?’ as ‘yes’.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
1335983|NCT01995513|Other Pre-specified|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
1335984|NCT01995513|Secondary|Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score|Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.|From randomization up to data cutoff date (07 Oct 2016)|Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment.|||months||95% Confidence Interval|Median
1335985|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1335986|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1336030|NCT01995201|Secondary|Mean Change in Total Swollen Joint Counts (SJC) From Baseline Until Week 24|SJC is a clinical assessment of 66 joints classified as swollen/not swollen by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints will not be taken into consideration for swelling.|From baseline to Week 24|Analysis was conducted on the FAS.SJC|||SJC||Standard Deviation|Mean
1336560|NCT01987349|Other Pre-specified|Lymphocyte Response to Influenza Immunization|Compare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines|Day 6-28 post-immunization|||||||
1335988|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1335989|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1335990|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, number analyzed (n) signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1335991|NCT01995513|Secondary|Time to First Use of New Antineoplastic Therapy for Prostate Cancer|It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment.|From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, up to the data cutoff date [07 Oct 2016])|ITT population included all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
1335992|NCT01995513|Secondary|Rate of Pain Progression|Rate of pain progression was defined as percentage of participants with an increase of >=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference.|Month 6|ITT population included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1335993|NCT01995513|Secondary|Objective Response Rate (ORR)|Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: >= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.|From randomization until CR or PR, whichever occurred first (up to the data cutoff date [07 Oct 2016])|ITT population (with measurable disease at screening) included all subjects randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1335994|NCT01995513|Secondary|Prostate Specific Antigen (PSA) Response Rate|PSA response rate was defined as percentage of participants with >=30% and >=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.|From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (up to the data cutoff date [07 Oct 2016])|Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1336031|NCT01995201|Secondary|Mean Change From Baseline in Total Tender Joint Counts (TJC) Until Week 48|TCJ is a clinical assessment of 68 joints which are classified as tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints are not be taken into consideration.|From week 24 until week 48|Analysis was conducted on the FAS.|||TJC||Standard Deviation|Mean
1336561|NCT01987349|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
1335995|NCT01995513|Secondary|Time to Prostate Specific Antigen (PSA) Progression|Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant’s whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of >=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant’s whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.|From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (up to the data cutoff date [07 Oct 2016])|ITT population included all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
1335996|NCT01995513|Primary|Progression Free Survival (PFS)|PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date.|From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (up to the data cutoff date [07 Oct 2016])|ITT population included all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
1335997|NCT01995461|Other Pre-specified|Change From Baseline Pain Medication Need/Use at 6 Months||baseline (pre-1st injection) to 6 months post-1st injection|||||||
1335998|NCT01995461|Secondary|Change From Baseline Oswestry Disability Index at 6 Months|The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients. The two sections of the Oswestry Disability Index (ODI) used in the present study were those related to walking and standing (sections 4 and 6). For each section, the total possible score is 5 and overall ODI score was expressed as a percentage of the maximum possible score (10). Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection||||points||95% Confidence Interval|Mean
1335999|NCT01995461|Secondary|Change From Baseline Swiss Spinal Stenosis Score at 6 Months|The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life. The Swiss spinal stenosis (SSS) questionnaire consists of 12 baseline questions asked of all participants prior to injection and an additional 6 questions asked at each time point post-treatment. The initial 12 questions assess reliability and condition at baseline while the 6 post-treatment questions assess treatment satisfaction. All questions ask the patient to assess symptoms over the previous month with a total maximum score for the initial 12 questions of 53 and a total maximum score of 24 for the 6 additional questions. The final total score is expressed as a percentage of the maximum possible score. Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection||||points||95% Confidence Interval|Mean
1336000|NCT01995461|Primary|Change From Baseline Pain Score at 6 Months|change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection|baseline (pre-1st injection) to 6 months post-1st injection||||points||95% Confidence Interval|Mean
1336001|NCT01995357|Primary|Degree of Leakage|"The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).~Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group."|10 (- 2 days)||||units on a scale||Standard Deviation|Mean
1336002|NCT01995201|Secondary|Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) up to Week 48|The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 160. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions.|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||FACIT-F score||Standard Deviation|Mean
1336003|NCT01995201|Secondary|Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) up to Week 24|The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 160. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions.|From baseline to Week 24|Analysis was conducted on the FAS|||FACIT-F score||Standard Deviation|Mean
1336004|NCT01995201|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) up to Week 48|"The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.~To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3."|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||HAQ-DI score||Standard Deviation|Mean
1336005|NCT01995201|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) up to Week 24|"The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.~To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3."|From baseline to Week 24|Analysis was conducted on the FAS.|||HAQ-DI score||Standard Deviation|Mean
1336006|NCT01995201|Secondary|Assessment of Pain Reported by the Patient (VAS) Until Week 48|This patient reported outcome assessment represents the patient’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as “no pain” and the extreme right end as “unbearable pain”.|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
1336007|NCT01995201|Secondary|Assessment of Pain Reported by the Patient (VAS) Until Week 24|This patient reported outcome assessment represents the patient’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as “no pain” and the extreme right end as “unbearable pain”.|From baseline to Week 24|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
1336008|NCT01995201|Secondary|Patient Global Assessment of Disease Activity Visual Analogue Scale (VAS) up to Week 48|This patient reported outcome assessment represents the patient’s overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line should be described as “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end as “maximum disease activity” (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded and the mean values are reported.|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
1336009|NCT01995201|Secondary|Patient Global Assessment of Disease Activity Visual Analogue Scale (VAS) up to Week 24|This patient reported outcome assessment represents the patient’s overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line should be described as “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end as “maximum disease activity” (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded and the mean values are reported.|From baseline to Week 24|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
1336010|NCT01995201|Secondary|Immunogenicity: SIL-6R Levels at Week 36 and Early Withdrawal Visit|Mean concentration of SIL-6R in patients' blood are reported.|Baseline, Week 36 and Early Withdrawal Visit|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
1336011|NCT01995201|Secondary|Immunogenicity: SIL-6R Levels up to Week 24|Mean concentration of SIL-6R in patients' blood are reported.|From baseline to Week 24|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
1336012|NCT01995201|Secondary|Immunogenicity: TCZ Levels at Week 36 and Early Withdrawal Visit|Mean concentrations of TCZ in patients' blood are reported.|week 36 and early withdrawal visit|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
1336013|NCT01995201|Secondary|Immunogenicity: TCZ Levels up to Week 24|Mean concentrations of TCZ in patients' blood are reported.|From baseline to Week 24|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
1336014|NCT01995201|Secondary|Immunogenicity: Number of Patients With Anti-tocilizumab Antibodies up to Week 48|Number of patients resulting positive to anti-tocilizumab antibodies test are reported.|From week 24 until week 48|Analysis was conducted on the FAS.|||Number of participants|||Number
1336015|NCT01995201|Secondary|Immunogenicity: Number of Patients With Anti-tocilizumab Antibodies up to Week 24|Number of patients resulting positive to anti-tocilizumab antibodies test are reported.|From baseline to Week 24|Analysis was conducted on the FAS.|||Number of participants|||Number
1336016|NCT01995201|Secondary|Safety: Number of Patients Reporting Adverse Events up to Week 48|Number of patients reporting any treatment emergent adverse event (TEAE), at least one TEAE of special interest, at least one serious TEAE, at least one TEAE leading to dose modification, at least one TEAE leading to discontinuation up to week 48|From week 24 until week 48|Analysis was conducted on the FAS.|||Number of participants|||Number
1336017|NCT01995201|Secondary|Safety: Number of Patients Reporting Adverse Events up to Week 24|Number of patients reporting any treatment emergent adverse event (TEAE), at least one TEAE of special interest, at least one serious TEAE, at least one TEAE leading to dose modification, at least one TEAE leading to discontinuation up to week 24|From baseline to Week 24|Analysis was conducted on the FAS.|||Number of participants|||Number
1336018|NCT01995201|Secondary|Percentage of Patients Who Achieved Low Disease Activity (LDA) Based on SDAI Score (SDAI<11) Until Week 48|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From week 28 until week 48|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
1336019|NCT01995201|Secondary|Percentage of Patients Who Achieved Low Disease Activity (LDA) Based on SDAI Score (SDAI<11) Until Week 24|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From baseline to Week 24|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
1336562|NCT01987349|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine||Day 0 to 28||||Participants|||Count of Participants
1336020|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on CDAI Score (CDAI<10) Until Week 48|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From week 28 until week 48|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
1336021|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on CDAI Score (CDAI<10) Until Week 24|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
1336022|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on DAS28-ESR Criteria (DAS28-ESR </=3.2) up to Week 48|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR was used to calculate the DAS28 score.|From week 28 until week 48|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
1336023|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on DAS28-ESR Criteria (DAS28-ESR </=3.2) up to Week 24|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR is used to calculate the DAS28 score.|From baseline to Week 24|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
1336024|NCT01995201|Secondary|Percentages of Patients With Remission (SDAI<3.3) Until Week 48|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From week 28 until week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336025|NCT01995201|Secondary|Percentages of Patients With Remission (SDAI<3.3) Until Week 24|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From baseline to Week 24|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336026|NCT01995201|Secondary|Percentages of Patients With Remission (CDAI<2.8) Until Week 48|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From week 28 until week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336027|NCT01995201|Secondary|Percentages of Patients With Remission (CDAI<2.8) Until Week 24|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336028|NCT01995201|Secondary|Percentages of Patients Who Achieve DAS28-ESR Remission (DAS28 < 2.6) up to Week 48|The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.|Week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Mean
1336029|NCT01995201|Secondary|Mean Change in Total Swollen Joint Counts (SJC) From Baseline Until Week 48|SJC is a clinical assessment of 66 joints classified as swollen/not swollen by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints will not be taken into consideration for swelling.|From week 24 until week 48|Analysis was conducted on the FAS.|||SJC||Standard Deviation|Mean
1336574|NCT01987219|Primary|Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline|The percentage change in respiratory function from baseline is measured in percentage change in Resistance, kPa/(L/s).|Pre and 30 minutes post study drug administration||||percentage change from baseline||Standard Deviation|Mean
1336032|NCT01995201|Secondary|Mean Change From Baseline in Total Tender Joint Counts (TJC) Until Week 24|TCJ is a clinical assessment of 68 joints which are classified as tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints are not be taken into consideration.|From baseline to Week 24|Analysis was conducted on the FAS.|||TJC||Standard Deviation|Mean
1336033|NCT01995201|Secondary|Mean Change in Simplified Disease Activity Index (SDAI) From Week 24 up to Week 48|Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From week 24 until week 48|Analysis was conducted on the FAS|||SDAI score||Standard Deviation|Mean
1336034|NCT01995201|Secondary|Mean Change in Simplified Disease Activity Index (SDAI) From Baseline up to Week 24|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From baseline to Week 24|Analysis was conducted on the FAS|||SDAI score||Standard Deviation|Mean
1336035|NCT01995201|Secondary|Mean Change From Baseline in Clinical Disease Activity Index (CDAI) up to Week 48|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From week 24 until week 48|Analysis was conducted on the FAS.|||CDAI score||Standard Deviation|Mean
1336036|NCT01995201|Secondary|Mean Change in Clinical Disease Activity Index (CDAI) From Baseline up to Week 24|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|Analysis was conducted on the FAS.|||CDAI score||Standard Deviation|Mean
1336037|NCT01995201|Secondary|Number of Patients With Clinical Response According to European League Against Rheumatism (EULAR) Response Scores up to Week 48|DAS28-based EULAR response criteria were used to measure individual response as good or moderate depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1.|From week 28 until week 48|Analysis was conducted on the FAS.|||Number of participants|||Number
1336038|NCT01995201|Secondary|Number of Patients With Good and Moderate Clinical Response According to European League Against Rheumatism (EULAR) Response Scores up to Week 24|DAS28-based EULAR response criteria were used to measure individual response as good or moderate depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1.|From week 2 until week 24|Analysis was conducted on the FAS|||Number of participants|||Number
1336039|NCT01995201|Secondary|Percentage of Patients With American College of Rheumatology (ACR20, 50, 70, 90) Response Scores Until Week 48|The definition of improvement of ACR core set of outcome measures includes an improvement equal or higher to the 20%, 50%, 70%, 90% compared to Baseline in both Swollen Joint Count (SJC) and Tender Joint Count (TJC) as well as in three out of five additional parameters: Physician’s Global Assessment of disease activity VAS, patient’s Global Assessment of disease activity VAS, patient’s assessment of pain VAS, HAQ-DI, and acute phase reactant (either CRP or erythrocyte sedimentation rate [ESR]).|From week 28 until week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336040|NCT01995201|Secondary|Percentage of Patients With American College of Rheumatology (ACR20, 50, 70, 90) Response Scores Until Week 24|The definition of improvement of ACR core set of outcome measures includes an improvement equal or higher to the 20%, 50%, 70%, 90% compared to Baseline in both Swollen Joint Count (SJC) and Tender Joint Count (TJC) as well as in three out of five additional parameters: Physician’s Global Assessment of disease activity VAS, patient’s Global Assessment of disease activity VAS, patient’s assessment of pain VAS, HAQ-DI, and acute phase reactant (either CRP or erythrocyte sedimentation rate [ESR]).|From week 2 until week 24|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336041|NCT01995201|Secondary|Percentage of Patients Reporting Change in DAS 28 ESR >1.2 Until Week 48|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR will be used to calculate the DAS28 score.|From week 28 up to week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336042|NCT01995201|Secondary|Percentage of Patients Allocated in Groups A1 and A2 Who Remain With Clinical Remission Activity (DAS 28 ESR <2.6) up to Week 48|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR will be used to calculate the DAS28 score.|From week 28 up to week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
1336043|NCT01995201|Secondary|Mean Change in Disease Activity Score 28 - Erythrocyte Sedimentation Rate(DAS28-ESR)|The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.|From week 24 up to week 48|Analysis was conducted on the FAS|||mm/hr||Standard Deviation|Mean
1336044|NCT01995201|Primary|Percentage of Participants Achieving Sustained Clinical Remission, Disease Activity Scale 28 - Erythrocyte Sedimentation Rate <26 (DAS28-ESR <2.6) at Week 20 and Week 24|The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.|Week 20 and Week 24|Analyses were conducted on the Full Analysis Set (FAS), i.e. all patients included in the study who received at least one dose of SC TCZ.|||Percentage of participants||95% Confidence Interval|Number
1336045|NCT01995136|Primary|Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.|Baseline (Day 0), Week 4, Week 8, Week 12|This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.|||mmHg||95% Confidence Interval|Least Squares Mean
1336046|NCT01995071|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of combination study drug|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1336047|NCT01995071|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment.|Up to 87 days|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV.|||participants||95% Confidence Interval|Number
1336048|NCT01995071|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of combination study drug.|12 weeks after last actual dose of combination study drug|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV; participants with missing data after backwards imputation were counted as nonresponders.|||percentage of participants|||Number
1336049|NCT01995071|Primary|Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment|Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1.|Day 1 through prior to first dose of the combination regimen on Study Day 4|Monotherapy Analysis Sets for Substudy 1 (Arms 1-5, 11) and SubStudy 2 (Arms 6-10, 12) are defined as all participants who received at least 1 dose of monotherapy and have a baseline and at least 1 postbaseline measurement of HCV RNA during monotherapy. Data for subjects who received the same treatment (Arms 4+5; Arms 7+10) were analyzed together.|||Log10 IU/mL||Standard Deviation|Mean
1336050|NCT01995045|Secondary|Mean Oxycodone Intake|The mean oxycodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)||||milligrams||Standard Deviation|Mean
1336051|NCT01995045|Secondary|Mean Hydrocodone Intake|The mean hydrocodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)||||milligrams||Standard Deviation|Mean
1336052|NCT01995045|Secondary|Mean Acetaminophen Intake|The mean acetaminophen use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)||||milligrams||Standard Deviation|Mean
1336053|NCT01995045|Primary|Mean Pain Score|The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.|Post-Operative Day 1 (Up to 24 hours)||||units on a scale||Standard Deviation|Mean
1336054|NCT01994993|Other Pre-specified|Number of Participants With Positive Blood Cultures|Positive blood culture (bacterial or fungal)|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336055|NCT01994993|Other Pre-specified|Number of Participants With Seizure|documented seizure(s) in hospital records|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336056|NCT01994993|Other Pre-specified|Number of Participants With Gastrointestinal Surgeries|Determined by medical history and confirmed with hospital records. (Laparotomy)|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336057|NCT01994993|Other Pre-specified|Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection|Progression is determined by the clinical NEC scoring|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336058|NCT01994993|Other Pre-specified|Number of Participants With Intestinal Stricture|"Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis.~Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336059|NCT01994993|Other Pre-specified|Number of Participants With Intestinal Perforation|"Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis.~Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336060|NCT01994993|Other Pre-specified|Number of Participants With Short Bowel Syndrome|"Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve.~Total parenteral nutrition for >42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336061|NCT01994993|Other Pre-specified|Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)|"Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement~Grade 4 IVH: Intraparenchymal hemorrhage"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336062|NCT01994993|Other Pre-specified|Number of Participants With Feeding Intolerance|Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
1336063|NCT01994993|Secondary|Number of Participants With Therapeutic Success at Day 30|"Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score >4.~Clinical cure score =1 for each of the following elements:~FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment"|30 days after last dose of study drug|Participants who received at least 1 dose of each study drug. Does not apply to Group 5.|||Participants|||Count of Participants
1336064|NCT01994993|Primary|Death|Number of Participants who experienced Death|Within 30 days after last dose of study drug, up to 40 days|Full intent-to-treat population (patients who received at least 1 dose of any study drug)|||Participants|||Count of Participants
1336065|NCT01994902|Primary|Degree of Leakage|The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).|28 +/- 3 days|The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.|||units on a scale|Participants|Standard Deviation|Mean
1336066|NCT01994876|Primary|Degree of Leakage|The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)|14 days||||units on a scale|Participants|Standard Deviation|Mean
1336067|NCT01994863|Primary|Leakage|The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14+/-3 days per product|Intention-to-treat population|||percentage of baseplates with no leakage|Participants||Number
1336068|NCT01994837|Secondary|Complete Remission Rate and Complete Remission With Incomplete Marrow Recovery (CRi) Rate|The complete remission rate and the complete remission with incomplete marrow recovery rate (Cri) was defined as the percentage of participants who achieved complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi), per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1336069|NCT01994837|Secondary|Complete Remission With Incomplete Marrow Recovery (CRi) Rate|The complete remission with incomplete bone marrow recovery (CRi) rate was defined as the percentage of participants who achieved CRi per the International Working Group criteria for AML. Complete remission with incomplete bone marrow recovery was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
1336070|NCT01994837|Secondary|Rate of Minimal Residual Disease (MRD) Negativity|The rate of minimal residual disease (MRD) response was defined as the percentage of participants who had MRD negative status. Only participants with a reported MRD assessment (negative or positive) from the local laboratory at the investigator site were used in the calculation of MRD response rate.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|Participants with available data|||percentage of participants||95% Confidence Interval|Number
1336071|NCT01994837|Secondary|Percentage of Participants Who Received Subsequent Stem Cell Transplant|The percentage of participants who received a subsequent allogenic (from a healthy donor) stem cell transplant was summarized.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
1336118|NCT01994486|Primary|Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks|The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.|1/3/2014-4/10/2014||||participants|||Number
1336072|NCT01994837|Secondary|Overall Survival|Overall survival was defined as the number of months from the date of enrollment to the date of death for all dosed participants. For participants who did not die, their data were censored at the date of last study visit or the last known date to be alive, whichever was later.|Measured up to 2 years after the last subject had enrolled in the study.|All participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1336073|NCT01994837|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from the date of enrollment to the date of earliest progression or death. If a participant did not experience disease progression or death, then the data was censored at the date of the last disease assessment.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1336074|NCT01994837|Secondary|Time to Progression|Time to progression was defined as the number of months from the date of enrollment to the date of earliest disease progression. If a participant did not experience disease progression, then the data for that participant was censored at the date of the last disease assessment.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1336075|NCT01994837|Secondary|Duration of Remission|Duration of remission was defined as the number of days from the date of first remission (CR, CRi, or PR) per the International Working Group criteria for AML to the earliest recurrence or progressive disease (PD). In this study, the duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|The duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.||||||
1336076|NCT01994837|Secondary|Complete Remission Rate|The complete remission (CR) rate was defined as the percentage of participants who achieved CR per the International Working Group criteria for AML. Complete remission was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
1336077|NCT01994837|Primary|Objective Remission Rate|The objective remission rate (ORR) was defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR) per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1336078|NCT01994785|Primary|Number of Participants Experiencing Hypoxia During Capnography Monitoring.||One day--data is collected during one endoscopic procedure.||||Participants|||Count of Participants
1336079|NCT01994746|Secondary|Time to Maximum Change From Baseline Concentration (Tmax) of Glucose||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacodynamics (PD) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hours||Full Range|Median
1336080|NCT01994746|Secondary|Maximum Change From Baseline Concentration (Cmax) of Glucose||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacodynamics (PD) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1336081|NCT01994746|Secondary|Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacodynamics (PD) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hr*mg/dL||Standard Deviation|Mean
1336082|NCT01994746|Secondary|Time to Maximum Change From Baseline Concentration (Tmax) of Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacokinetics (PK) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hours||Full Range|Median
1336083|NCT01994746|Secondary|Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacokinetics (PK) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1336084|NCT01994746|Secondary|Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Baseline-Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacokinetics (PK) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hour*picograms per milliliter (hr*pg/mL)||Standard Deviation|Mean
1336119|NCT01994486|Secondary|Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen|Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)|6/16/2014-7/2/2014||||participants|||Number
1336085|NCT01994746|Secondary|Time From Glucagon Administration to Blood Glucose >/=70 mg/dL or an Increase ≥20 mg/dL in Blood Glucose From Nadir|The mean time from glucagon administration to blood glucose >/=70 mg/dL or an increase ≥20 mg/dL in blood glucose from nadir.|Pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with eligible glucose and glucagon levels. Study dosing visits occur on Day 0 and then again after the washout period between Day 7 to Day 28.|||minutes|||Number
1336086|NCT01994746|Secondary|Recovery From Symptoms of Hypoglycemia|Recovery from hypoglycemia symptoms were assessed using the Edinburgh Hypoglycemia Scale. The Edinburgh Hypoglycemia Symptom Scale measures the intensity of 15 commonly experienced hypoglycemic symptoms on a 7-point Likert scale (1 = not present, 7 = very intense). The higher the score, the more intense the hypoglycemia symptoms. The sum of each symptom score would yield a range of 15 to 105 (i.e., 15 x 7 =105). The total score was calculated as the sum of each symptom score minus 15, and summarized at each time point by treatment group.|Pre-dose;15, 30, 45 and 60 minutes following administration of glucagon|All enrolled participants who completed at least one post administration survey.|||units on a scale||Standard Deviation|Mean
1336087|NCT01994746|Secondary|Nasal and Non-nasal Effects/Symptoms|"Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed. This was done via the Nasal Non-nasal Score Questionnaire. Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each subject and reporting the median/IQR across participants)."|Pre-dose; 15, 30, 60, and 90 post glucagon administration|All enrolled T1D participants that completed the required dosing visits. Study dosing visits occur on Day 0 and then again after the washout period between Day 7 to Day 28.|||units on a scale||Inter-Quartile Range|Median
1336088|NCT01994746|Primary|Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL From Glucose Nadir|Increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level defines treatment success. Due to the residual activity of circulating insulin, glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes following glucagon administration.|Within 30 minutes after receiving glucagon at both dosing visits (glucose was measured at pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration)|All enrolled participants who completed both eligible Study/Dosing Visits.|||percentage of participants|||Number
1336089|NCT01994720|Secondary|Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event|Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|Time from first dose and up to and including 7 days following the date of last dose of the study|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.|||Participants|||Number
1336090|NCT01994720|Secondary|Number of Participants With PLATO Major Bleeding Event|"Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).~PLATO Major bleeding is defined as a bleed that is any one of:~Fatal~Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)~Intrapericardial bleed with cardiac tamponade~Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery~Significantly disabling (eg. intraocular with permanent vision loss)~Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)~Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding."|From randomization up to 97 days|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.|||Participants|||Number
1336091|NCT01994720|Secondary|EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit|"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Premature treatment discontinuation visit(<15 days after last dose)|Include only results from patients who visit the site in-person. The Premature Treatment Discontinuation visit (PTDV) is only done for patients who prematurely and permanently stop study medication.|||Index score||Standard Deviation|Mean
1336092|NCT01994720|Secondary|EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit|"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|End of treatment visit (Day 90+-7d)|Include only results from patients who visit the site in-person.|||Index score||Standard Deviation|Mean
1336107|NCT01994629|Secondary|Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 to Day 29 or Day 1 to Day 180 post-vaccination|Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.|||Subjects|||Number
1336093|NCT01994720|Secondary|EQ-5D at Visit 2 (Day 7+-2d)|"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Visit 2 (Day 7+-2d)|Include only results from patients who visit the site in-person.|||Index score||Standard Deviation|Mean
1336094|NCT01994720|Secondary|EQ-5D at Visit 1 (Enrolment)|"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Visit 1 (Enrolment)|Include only results from patients who visit the site in-person.|||Index score||Standard Deviation|Mean
1336095|NCT01994720|Secondary|Change in NIHSS|"Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):~0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke."|From randomization up to 97 days|NIHSS in patients with an index stroke event|||Participants|||Number
1336096|NCT01994720|Secondary|Number of Participants With Disabling Stroke|Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336097|NCT01994720|Secondary|Number of Participants With Fatal Stroke|Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336098|NCT01994720|Secondary|Number of Participants With Stroke|Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336099|NCT01994720|Secondary|Number of Participants by Severity of Stroke and Overall Disability|"Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.~Modified Rankin Score:~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~Disability defined as mRS > 1.~Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables."|From randomization up to 97 days|The population was the full analysis set which included all randomized patients.|||Participants|||Number
1336100|NCT01994720|Secondary|Number of Participants With MI|Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336101|NCT01994720|Secondary|Number of Participants With CV Death|Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336102|NCT01994720|Secondary|Number of Participants With All-Cause Death|Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336103|NCT01994720|Secondary|Number of Participants With Composite of Ischaemic Stroke, MI and CV Death|Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336104|NCT01994720|Secondary|Net Clinical Outcome|Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336105|NCT01994720|Secondary|Number of Participants With Ischaemic Stroke|Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336106|NCT01994720|Primary|Number of Participants With Composite of Stroke/MI/Death|Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1336117|NCT01994486|Secondary|Proportion of Subjects With Viral Relapse|Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point.|1/3/2014-9/8/2014||||participants|||Number
1342701|NCT01910389|Secondary|Frequency of HF Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
1336108|NCT01994629|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 (6 hours) to Day 7 post-vaccination|Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).|||Subjects|||Number
1336109|NCT01994629|Secondary|rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||Titers||95% Confidence Interval|Geometric Mean
1336110|NCT01994629|Secondary|Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
1336111|NCT01994629|Secondary|Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
1336112|NCT01994629|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
1336113|NCT01994629|Secondary|hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||Titers||95% Confidence Interval|Geometric Mean
1336114|NCT01994629|Secondary|Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer < 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
1336115|NCT01994629|Secondary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).|||percentage of Subjects||95% Confidence Interval|Number
1336116|NCT01994629|Primary|Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.|Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.|Day 1 to Day 7 post-vaccination|Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).|||Number of Subjects|||Number
1336122|NCT01994486|Primary|Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir|Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.|12 weeks-January 3, 2014- April 10, 2014|Non-cirrhotic Hepatitis C Genotype 1 infected subjects, naive to previous Hepatitis C treatment|||participants|||Number
1336123|NCT01994395|Secondary|Berg Balance Scale (BBS)|The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance. The minimal detectable change score for individuals with acute stroke is 6.9 points16 and 4.66 points in chronic stroke17.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale, each item scored 0-4||Standard Deviation|Mean
1336124|NCT01994395|Secondary|Change in 6 Minute Walk Test From Baseline in Distance (6MWT)|"The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed, but time will keep running. The change in the distance walked in the 6-minute walk can be used to evaluate the efficacy of an exercise-training program or to trace the natural history of change in exercise capacity over time. The 6MWT is measured in meters."|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
1336125|NCT01994395|Secondary|Participants Receiving Transcranial Magnetic Stimulation (TMS)|To compare the effect of training on the connections between the brain and leg muscles (descending corticomotor drive) using a non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals13. Very short duration (< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram (EMG) from that muscle. A figure-of-eight or double cone coil is typically used to deliver focal magnetic pulses to a number of scalp sites over the cortical area representing a muscle of interest.|Session 0 (initial visit);Session 20 (between 6-8 weeks)|One subject dropped before being assigned to a group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||Participants|||Count of Participants
1336126|NCT01994395|Secondary|Patient Health Questionnaire-9 (PHQ-9)|PHQ-9 is a 9-item self-report questionnaire designed to diagnose both the presence of depressive symptoms as well as to characterize the severity of depression. A single question rates how difficult problems have made it to do work, take care of things at home or get along with other people using a 4 level scale (not difficult at all to extremely difficult). Each item is scored from 0-3; total scores may be 0-27, with higher scores representing increased severity of depression.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
1336127|NCT01994395|Secondary|The Modified Falls Efficacy Scale (mFES)|14 item questionnaire assessing individuals' confidence in their ability to perform tasks without falling. Individuals rate their confidence from 0 (not confident at all) to 100 (completely confident).|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
1336128|NCT01994395|Secondary|Stroke Specific Quality of Life Scale (SS-QOL)|A 49 item assessment grouped into 12 domains of health-related quality of life in stroke survivors; including areas of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking, personality. Each individual domain consists of 3 to 10 items that are averaged to generate an overall score, each item is rated on a 5- point Likert scale, with a minimum value of 1 (meaning the worst outcome) and a maximum value of 5 (meaning the best outcome). Domains scores (non-weighted average of item scores) and a summary score (non-weighted average of all 12 domain scores) are computed. Summary scores range from 49-245, with higher scores indicating better functioning.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
1336129|NCT01994395|Secondary|Numeric Pain Rating Scale (NPRS)|The NPRS is an 11-point scale from 0-10 where patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours from 0 (no pain) to 10 (the most intense pain imaginable).|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
1336130|NCT01994395|Secondary|Activities-Specific Balance Confidence Scale (ABC)|ABC is a 16-item self-report measure in which patients rate their balance confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
1336131|NCT01994395|Primary|Change in 10 Meter Walk Test From Baseline in Gait Speed|"Measure of self selected and fast walking speeds by measuring the time it takes an individual to walk 10 meters. The test is performed using a flying start, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: Please walk this distance at your normal pace when I say go. and repeated Please walk this distance as fast as you can safely when I say go."|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||meters per second||Standard Deviation|Mean
1336132|NCT01994291|Other Pre-specified|Number of Participants With Change in Ophthalmoscopy Examination Results in Study Eye After Administration of Ranibizumab or Masked Sham Therapy at Week 8|Ophthalmoscopy ought to be performed after pupillary dilation to examine the vitreous body, optic nerve head, macular and peripheral retina. All findings, including the presence or absence of vitreous inflammation, ought to be documented. All post-dose ophthalmoscopy assessments ought to be made immediately following the administration of ranibizumab or masked sham therapy.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
1336133|NCT01994291|Other Pre-specified|Maximum Increase of Intraocular Pressure (IOP) From Baseline in Study Eye|IOP was measured using Goldmann applanation tonometry. To maintain consistency, it was recommended that the same examiner ought to measure IOP with the same tonometer at each visit for a given subject. Intraocular pressure ought to be measured in the study eye approximately 30 minutes after intravitreal injection or masked sham therapy (performed by unmasked study team member).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||mmHg||Standard Deviation|Mean
1336134|NCT01994291|Other Pre-specified|Number of Participants With Changes in the Anterior Segment of the Study Eye at Week 12|The anterior biomicroscopy exam was done undilated in order to assess whether there was any anterior segment inflammation caused either by ranibizumab or PF-04634817.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
1336135|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=200 msec or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QT interval >=500 msec; and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
1336136|NCT01994291|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed for abnormalities at any time point: hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count); blood chemistry (sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase); follicle-stimulating hormone (FSH) (Weeks -5 to 0 only, for postmenopausal women who have been amenorrheic for at least 12 consecutive months prior to screening visit).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
1336137|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs|Number of participants who met the categorical summary of post-baseline criteria at any time point, defined as: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine systolic blood pressure (SBP) ≥30 millimeters of mercury (mmHg) change from baseline in same posture; supine diastolic BP (DBP) ≥20 mmHg change from baseline in same posture; supine SBP <90 mmHg; supine DBP <50 mmHg.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
1336138|NCT01994291|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 0 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
1336139|NCT01994291|Secondary|Plasma Concentration of PF-04634817 up to Week 12||Week 0, Week 4, Week 8, and Week 12|All subjects in the full analysis set (FAS) for whom a pharmacokinetic sample was obtained and analyzed. The FAS was defined as all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1336171|NCT01993030|Secondary|Number of Participants With Growth of Granulation Tissue|Physician assessment of tissue with healthy granulation tissue defined as is granular and uneven in texture, does not bleed easily and is pink in color. Unhealthy granulation tissue is typically dark which can be indicative of poor perfusion, ischemia and/or infection.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||participants|||Number
1336140|NCT01994291|Secondary|Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12|Stereo color fundus photographs using certified digital systems were taken by a photographer who had been pre-certified (“study certified”) by the Central Reading Center. They were evaluated by the Central Reading Center.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||Letters||80% Confidence Interval|Least Squares Mean
1336141|NCT01994291|Secondary|Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12|Fluorescein Angiography (FA) using certified digital systems was taken by a photographer who had been pre-certified (“study-certified”) by the Central Reading Center. They were evaluated by the Central Reading Center.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||mm^2||80% Confidence Interval|Least Squares Mean
1336142|NCT01994291|Secondary|Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12|A central reading center was used for the evaluation. A photographer or technician pre certified (“study certified”) by the Central Reading Center ought to perform all optical coherence tomography (OCT) imaging. Use of a Spectralis or Cirrus OCT was acceptable.|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||microns||80% Confidence Interval|Least Squares Mean
1336143|NCT01994291|Secondary|Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated ETDRS charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||proportion of participants|||Number
1336144|NCT01994291|Primary|Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||Letters||80% Confidence Interval|Least Squares Mean
1336145|NCT01994226|Primary|Change in Pain Intensity|Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome|Days 0-7||||units on a scale||Standard Deviation|Mean
1336146|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. The severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||SBMs with no straining / week||Standard Error|Least Squares Mean
1336147|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||complete spontaneous BMs / week||Standard Error|Least Squares Mean
1336148|NCT01993940|Secondary|Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM. Baseline was defined as the 14 days in the screening period prior to study drug administration.|Baseline and Week 1|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
1336149|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM. Baseline was defined as the 14 days in the screening period prior to study drug administration.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
1336150|NCT01993940|Primary|Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.~A responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a “non-response” week.~Any participant with insufficient primary endpoint data (data for less than 9 out of the 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder"|12-week treatment period|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
1336151|NCT01993888|Secondary|Incidence of Adverse Events That Were Potentially Related to Thrombotic Events|Number of participants with adverse events that were potentially related to thrombic events|Up to 60-days following surgery||||participants|||Number
1336154|NCT01993888|Secondary|Absolute Time to Hemostasis|The absolute time to achieve hemostasis at or after 4 minutes from randomization.|Intraoperative, an average of 4.2 minutes following randomization|Time to hemostasis (TTH), defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization was evaluated as a secondary endpoint. In one subject in the SoC group, manual compression was not maintained until the 4-minute endpoint, but was released early and a suture was applied, at which point the subject was hemostatic.|||minutes||Full Range|Median
1336155|NCT01993888|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization|Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.|Intraoperative, 10 minutes following randomization|The proportion of subjects achieving hemostatic success at 10 minutes following randomization was evaluated as a secondary endpoint using the logistic model with treatment and site/institution included in the model.|||participants with hemostatic success|||Number
1336156|NCT01993888|Primary|Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization|Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.|Intraoperative, 4 minutes following randomization|The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set.|||participants with hemostatic success|||Number
1336157|NCT01993823|Other Pre-specified|Mycological Study||Day 24|||||||
1336158|NCT01993823|Secondary|Changes in Signs/ Symptoms|"The secondary efficacy variables include:~Proportion of subjects with signs and symptoms score of “0” at Day 15~Proportion of subjects with signs and symptoms score of “0” at Day 24~Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24."|2 weeks and 4 weeks|ITT|||percentage of patient|||Number
1336159|NCT01993823|Primary|Proportion of Subjects With a Complete Response to Treatment|"Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24.~Response to the study treatment was classed according to the following definitions:~Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24.~Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24.~No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms > 2 on day 24."|Day 24|ITT|||participants|||Number
1336160|NCT01993238|Secondary|Pain Scores Reported at 1-day Post-Treatment|During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable).|1 day|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
1336161|NCT01993238|Secondary|Safety Assessment|Adverse events will be assessed and documented throughout the study|Baseline, 1 day, 1 week|||||||
1336162|NCT01993238|Primary|Pain Score for Overall Treatment|Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)|Baseline|Intent to Treat|||units on a scale||Standard Deviation|Mean
1336163|NCT01993108|Secondary|Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.|The effects of methylphenidate, naltrexone, and placebo on the change in BOLD (Blood Oxygen Level Dependent) signal will be characterized in the incongruent condition (cognitive regulation condition) of the MSIT (multi-source interference task) relative to the congruent condition (no regulation condition). Specifically, the summed BOLD signal in three regions--dorsal lateral prefrontal cortex, anterior insula, anterior cingulate--are measured.|Two hours||||Mean percentage of BOLD signal change||Standard Deviation|Mean
1336164|NCT01993108|Secondary|Accuracy on the Multi-Source Interference Task|Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task.|Two hours||||percent of total trials||Standard Deviation|Mean
1336165|NCT01993108|Secondary|Reaction Time on the Multi-Source Interference Task|Reaction time of the Multi-Source Interference Task is measured in seconds.|Two hours||||seconds||Standard Deviation|Mean
1336166|NCT01993108|Primary|Reaction Time Variability on the Multi-Source Interference Task|Multi-Source Interference Task is a psychological task that measures the psychological construct of cognitive control, the ability to suppress automatic response tendencies. Reaction time variability is the standard deviation of the trial to trial reaction time measured in seconds.|2 hours||||seconds||Standard Deviation|Mean
1336167|NCT01993030|Primary|Time to Wound Healing|Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||Days||Standard Deviation|Mean
1336168|NCT01993030|Secondary|Number of Participants With Exudation|"Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation:~Less than two gauze was soaked by exudation within 24h---No exudation (-);~Two to four gauze was soaked by exudation within 24h---Little exudation (+);~More than four gauze was soaked by exudation within 24h---Much exudation (++);"|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||participants|||Number
1336169|NCT01993030|Secondary|Pain Perceived by Patient|The amount of pain that a patient perceived was assessed using a Visual Analogue Scale (VAS 0-10), which ranges across a continuum from 0 (no pain) to 10 (worst pain).|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||units on a scale||Standard Deviation|Mean
1336170|NCT01993030|Secondary|Number of Participants With Inflammatory Reaction|Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||participants|||Number
1338874|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 28|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 28|Patients who have trough concentration data at Day 28|||μg/mL||Standard Deviation|Mean
1336172|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Progressive Disease (PD)|PD as per RECIST v1.1 defined as 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
1336173|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Stable Disease (SD)|SD as per RECIST v1.1 defined as neither shrinkage to qualify for PR nor increase to qualify for progressive disease (PD) taking the smallest sum diameters on study as reference. PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; PD = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
1336174|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Partial Response (PR)|PR as per RECIST v1.1 defined as 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
1336175|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR)|CR as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 defined as disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm).|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
1336176|NCT01992874|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|From the first dose of study drug administration until 30 days after the last dose of study drug administration, assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
1336177|NCT01992874|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUC 0-t)|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration was at or above the lower limit of quantification.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1336178|NCT01992874|Secondary|Terminal Rate Constant (λz)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||1/h||Full Range|Median
1336179|NCT01992874|Secondary|Apparent Volume of Distribution (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1336180|NCT01992874|Secondary|Apparent Total Body Clearance (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1336181|NCT01992874|Secondary|Apparent Terminal Half-life (t1/2)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||hour||Full Range|Median
1336182|NCT01992874|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.|||hour||Full Range|Median
1336305|NCT01990794|Secondary|Changes in Cardiac Function|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||cm||Standard Deviation|Mean
1336183|NCT01992874|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-inf)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analysed) signifies the number of subjects analysed for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1336184|NCT01992874|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|Pharmacokinetic (PK) analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1336185|NCT01992536|Secondary|26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.|Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)|From primary parent study completion up to Day 1 in this study.|Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).|||Participants|||Number
1336186|NCT01992536|Secondary|25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.|Day 1 to Day 365|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.|||Participants|||Number
1336187|NCT01992536|Secondary|24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.|"Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30.~Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30."|Day 1 through Day 30|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.|||Participants|||Number
1336188|NCT01992536|Secondary|23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.|From day 1 (6 hours) through day 7 after any vaccination|Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.|||Participants|||Number
1336189|NCT01992536|Secondary|22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
1336190|NCT01992536|Secondary|21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
1336191|NCT01992536|Secondary|20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
1336192|NCT01992536|Secondary|19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
1336193|NCT01992536|Secondary|18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
1336402|NCT01989130|Primary|Resolution of Symptoms|Number of patients that report having no symptoms 7 to 10 days after initial encounter|one year|Analysis of patients who completed the 7-10 day follow-up phone call|||Participants|||Count of Participants
1336194|NCT01992536|Secondary|17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
1336195|NCT01992536|Secondary|16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
1336196|NCT01992536|Secondary|15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination.~Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
1336197|NCT01992536|Secondary|14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
1336198|NCT01992536|Secondary|13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
1336199|NCT01992536|Secondary|12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.|Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
1336200|NCT01992536|Secondary|11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.|Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
1336201|NCT01992536|Secondary|10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
1336202|NCT01992536|Secondary|9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.~Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
1336203|NCT01992536|Secondary|8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Titers||95% Confidence Interval|Geometric Mean
1336204|NCT01992536|Secondary|7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Titers||95% Confidence Interval|Geometric Mean
1336403|NCT01989130|Primary|Healthcare Cost|To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter|one year|This outcome measure was not measured, as insurance coverage for hospital and physician charges was unavailable.||||||
1336205|NCT01992536|Secondary|6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.|"The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Titers||95% Confidence Interval|Geometric Mean
1336206|NCT01992536|Secondary|5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.|"The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Titers||95% Confidence Interval|Geometric Mean
1336207|NCT01992536|Secondary|4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|"Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Percentages of Subjects||95% Confidence Interval|Number
1336208|NCT01992536|Secondary|3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.|"Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Percentages of Subjects||95% Confidence Interval|Number
1336209|NCT01992536|Primary|2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.|Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
1336210|NCT01992536|Primary|1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.|Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.|Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
1336211|NCT01992523|Secondary|Dyspnoea and/or Symptomatic Bradycardia|Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia|6 months|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%)|||percentage of partecipants|||Number
1336212|NCT01992523|Secondary|Bleeding Events|Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events|48 hours||||percentage of partecipants|||Number
1336213|NCT01992523|Secondary|High Residual Platelet Reactivity|The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.|1 hour|Categorical data were expressed as proportions (%)|||percentage of partecipants|||Number
1336214|NCT01992523|Primary|Residual Platelet Reactivity|residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.|1 hour|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). A P value < .05 was considered statistically significant. All tests were two-sided.|||PRU (P2Y12 reaction units)||Inter-Quartile Range|Median
1336215|NCT01992185|Primary|Percent Repigmentation||90 days||||Percent Repigmentation||Standard Deviation|Mean
1336216|NCT01992172|Primary|Number of Pruritus Events in Last 30 Days||30 days from baseline||||Events||Standard Deviation|Mean
1336217|NCT01992107|Secondary|Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.|Day 1 to 210 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data|||Subjects|||Number
1336404|NCT01989130|Primary|Health Utilization|Quantify the number of visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment|one year|Analysis included patients that responded to the 7-10 day follow-up phone call.|||Participants|||Count of Participants
1336218|NCT01992107|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.|Day 1 to 7 after last vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data|||Subjects|||Number
1336219|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c|"Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
1336220|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain|"Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
1336221|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c|"Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c.~Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
1336222|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
1336223|NCT01992107|Secondary|Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age|Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set|||Ratios||95% Confidence Interval|Geometric Mean
1336224|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70%|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set|||percentages of subjects||95% Confidence Interval|Number
1336225|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set|||percentages of subjects||95% Confidence Interval|Number
1336233|NCT01992094|Secondary|10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain|"Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
1336405|NCT01989130|Primary|Percentage of Participants Prescribed Antibiotic Treatment|Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups|one year||||percentage of 70 participants|||Number
1336226|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.~The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set (FAS) i.e. all subjects in the enrolled set who received at least one study vaccination and provided immunogenicity data at day 22 (day 50 for not previously vaccinated subjects)|||percentages of subjects||95% Confidence Interval|Number
1336227|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.~The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Full Analysis Set (FAS) immunogenicity set i.e. all subjects in the enrolled set who received ▫ Received at least one study vaccination and provided immunogenicity data at day 1 and day 22 (day 50 for not previously vaccinated subjects)|||percentages of subjects||95% Confidence Interval|Number
1336228|NCT01992107|Primary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on PP population|||percentages of subjects||95% Confidence Interval|Number
1336229|NCT01992107|Primary|Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.~Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly received the vaccine, had no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis|||Titers||95% Confidence Interval|Geometric Mean
1336230|NCT01992094|Secondary|13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 181 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data|||Subjects|||Number
1336231|NCT01992094|Secondary|12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 7 post vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data|||Subjects|||Number
1336232|NCT01992094|Secondary|11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain|Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
1336262|NCT01991314|Secondary|Intolerance of Oral Iron|Numbers of patients who reported intolerance of oral iron (abdominal pain, nausea, vomiting, constipation, diarrhoea or headache)|Baseline (0 weeks) to end of trial (6 weeks)||||Participants|||Count of Participants
1336234|NCT01992094|Secondary|9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain|Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
1336235|NCT01992094|Secondary|8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1."|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
1336236|NCT01992094|Secondary|7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||percentages of subjects||95% Confidence Interval|Number
1336237|NCT01992094|Secondary|6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||percentages of subjects||95% Confidence Interval|Number
1336238|NCT01992094|Secondary|5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||Ratio||95% Confidence Interval|Geometric Mean
1336239|NCT01992094|Secondary|4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||percentages of subjects||95% Confidence Interval|Number
1336240|NCT01992094|Secondary|3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set i.e. all subjects in the enrolled set who receive the study vaccination and provide immunogenicity data at visit 1 and visit 2|||percentages of subjects||95% Confidence Interval|Number
1336241|NCT01992094|Primary|2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer|Three weeks post vaccination (Day 22)|Analysis was done on PP population|||percentage of subjects||95% Confidence Interval|Number
1336242|NCT01992094|Primary|1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.~Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Three weeks post vaccination (Day 22)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis|||Titer||95% Confidence Interval|Geometric Mean
1336243|NCT01992016|Primary|Number of Participants With Increase in SUV Uptake|"Number of participants who had increased SUV uptake, as defined by any of the following:~SUVmax increase of 30% with a 2 unit absolute change.~SUVmean increase of 30% with a 0.75 unit absolute change.~SUVmean increase of 20% with a 1 unit absolute change."|Within 1 week after completion of ranolazine treatment|This study was closed to accrual early. Due to small numbers, no statistical or firm conclusions can be made on the basis of such small numbers.|||Participants|||Count of Participants
1336244|NCT01991990|Primary|Absolute Median Fluorescence Intensities of Neutrophil Adhesion Molecules|Neutrophil surface receptor expression may be used to characterize the activation status of neutrophils. Fresh (0 min), PBS control (30 min) and fMLP-stimulated (30 min) PMNs (5 × 10^6 PMNs/mL) were fixed with CellFIX, and 90 μL transferred to each tube containing antibody mixture (2 μL cluster of differentiation [CD] 11b-brilliant violet (BV) 421, 2 μL CD16-FITC, 5 μL CD62L-allophycocyanin (APC) and 5 μL CD162-phycoerythrin [PE]) or isotype control mixture of equivalent volumes. After 30 minutes of incubation on ice and in the dark, cold PBS was added to stop further reaction. Surface marker expressions were quantified by flow cytometry.|Day 4|Safety analysis population|||median fluoresence intensity||Standard Error|Mean
1336245|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Microscopic Morphology|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by microscopy with neutrophils classified as shape-changed if they contained > 1 cell surface bleb or irregularity and change from baseline in percentage of neutrophil with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||percentage of shape changed neutrophils||Standard Error|Mean
1336246|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Flow Cytometry (FSC-High Cells)|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring FSC on flow cytometry. Change from baseline in the percentage of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||percentage of shape changed neutrophils||Standard Error|Mean
1336247|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to Nadir in the Number of Neutrophils With Shape Change Measured Using Flow Cytometry|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), phosphate-buffered saline (PBS) control (30 min control) and formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ milliliter [mL]) were fixed with CellFIX (organic solvent used as fixative for adherent cells), 90 microliters (μL) transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring forward scatter (FSC) on flow cytometry. Change from baseline in the number of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||neutrophils with shape change||Standard Error|Mean
1336248|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir in the Percentage of Apoptotic Neutrophils as Measured by Flow Cytometry|Ageing neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of Annexin V (AV) to bind exposed phosphatidylserine. Propidium Iodide (PI) is normally membrane-impermeable but enters cells in late apoptosis when their plasma membrane becomes leaky. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptosis was assessed by flow cytometry with fluorescein isocyanate-labeled recombinant human AV (AV-FITC) and PI staining and the change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by flow cytometry is reported.|Baseline, Day 4|Safety analysis population|||percentage of apoptotic neutrophils||Standard Error|Mean
1336249|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir (Day 4) in the Percentage of Apoptotic Neutrophils as Measured by Microscopic Morphology|Neutrophil apoptosis was measured using microscopy method with slides stained with Diff-Quik (modified Wright Giemsa stain) and morphology examined under oil immersion light microscopy with 100 times magnification. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptotic neutrophils were characterized with dark and pyknotic nuclei compared to the viable neutrophils. Change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by microscopy is reported.|Baseline, Day 4|Safety analysis population|||percentage of apoptotic neutrophils||Standard Error|Mean
1336250|NCT01991990|Primary|Neutrophil Respiratory Burst: Change From Baseline to Nadir (Day 4) in the Production of Reactive Oxygen Species as Measured by Chemiluminescence (Relative Light Units - Absolute)|Neutrophils generate a respiratory burst using reactive oxygen species (ROS) to kill invading pathogens. When luminol is used as a substrate for ROS, a chemical reaction is produced resulting in photon emission (chemiluminescence) in primed and unprimed neutrophils following formyl-methionyl-leucyl-phenylalanine (fMLP) stimulation which is quantifiable. fMLP stimulation of the respiratory burst is mediated through activation of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase in primed neutrophils. The maximal fMLP response is observed in primed neutrophils and is an ex vivo measure of the capacity of neutrophils to respond to pathogenic stimuli. In the current experiments, neutrophils were primed with tumor necrosis factor alpha (TNFα). Light emission was recorded on a luminometer. Absolute change from baseline in the production of ROS on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||relative light units||Standard Error|Mean
1336263|NCT01991314|Primary|Mean Change in Haemoglobin Concentration.|Change in serum Hb concentration in g/dl after 6 weeks of oral iron|Baseline (0 weeks) and end of trial (6 weeks)|Intention to treat population|||g/dl||Standard Error|Mean
1336251|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in Median Fluorescence Intensity (MFI) of eFluor670+ Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4˚C (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the eFluor670+ MFI was calculated on Day 4.|Baseline, Day 4|Safety analysis population|||median fluoresence intensity||Standard Error|Mean
1336252|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in the Percentage of eFluor670-Positive (eFluoro670+) Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia (S.pneumonia) bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4 degrees(˚) centigrade (C) (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the percentage of eFluor670+ neutrophils was calculated on Day 4.|Baseline, Day 4|Safety analysis population.|||percentage of eFlouro+ neutrophils||Standard Error|Mean
1336253|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 10|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 10 (6 days post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 10|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.|||percentage of Day 4 counts||Standard Error|Mean
1336254|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 5|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 5 (24-hours post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 5|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.|||percentage of Day 4 counts||Standard Error|Mean
1336255|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 4 (Neutrophil Nadir)|On Day 4 participants had neutrophils isolated from 100 milliliters (mL) of acid-citrate dextrose (ACD)-anti-coagulated autologous venous blood and labeled in autologous plasma with up to 2.5 megaBecquerel (MBq) 111 Indium (111In)-tropolonate before being reinjected. Participants rested for 45 minutes (min) post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils on Day 4 (45 min post re-injection) in the blood, liver/spleen and pelvic bone marrow, expressed as percentages of total body counts (TBCs).|Day 4|Safety analysis population: Includes all the participants who received the single dose of randomized study medication. One participant in the polymorphonuclear leukocyte (PMN)-high group was excluded due to external contamination affecting profiling data.|||percentage of total body count||Standard Error|Mean
1336256|NCT01991548|Primary|User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.|Four weeks of pump wear||||units on a scale||Standard Deviation|Mean
1336257|NCT01991314|Secondary|Changes in Stress Levels|Perceived Stress Questionnaire (PSQ)-G is a 30-question measure of perceived stress giving total scores ranging between 30 (very unstressed) to 120 (very stressed).|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol analysis|||units on a scale||Standard Error|Mean
1336258|NCT01991314|Secondary|Changes in Fatigue|Multidimensional Fatigue Inventory (MFI) is a 20 question-based scale with total scores ranging between 20 (very good) and 100 (very severe fatigue).|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol|||units on a scale||Standard Error|Mean
1336259|NCT01991314|Secondary|Changes in Anxiety|Hospital Anxiety and Depression Score (HADS)-A, a scale of 7 questions score 0-3 each, so that total score 0 is good and 21 very severe anxiety.|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol|||units on a scale||Standard Error|Mean
1336260|NCT01991314|Secondary|Change in Quality of Life Score|Short Inflammatory Bowel Disease Questionnaire (SIBDQ score), a health-related quality of life tool measuring physical, social, and emotional status (summated to produce a score of minimum 10 to maximum 70, representing poor to good quality of life, respectively). (Reporting of individual domain subscores is not valid).|Baseline (0 weeks) to end (6 weeks)|Per protocol analysis|||scores on a scale||Standard Error|Mean
1336261|NCT01991314|Secondary|Change in Disease Activity (Stool Calprotectin)|Difference between faecal calprotectin measured at baseline and at end of study|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol analysis|||ug/g||Standard Error|Mean
1336265|NCT01990859|Secondary|Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response|Best Overall Response Rate (BORR) was defined as the total number of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants (%). A two-sided, exact 95% Confidence Interval (Clopper and Pearson) for the BORR was calculated. Overall response (OR) was determined using modified World Health Organization (mWHO) criteria: Complete Response = complete disappearance of all index and non-index lesions, and no new lesions. Partial Response = decrease in index lesions of 50% or greater in a SPD relative to baseline, and no new lesions. BOR=an overall response of CR or PR at Week 12 or after Week 12.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||percentage of participants||95% Confidence Interval|Number
1336266|NCT01990859|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response|Overall response (OR) was determined using modified World Health Organization (mWHO) criteria. Complete response (CR): complete disappearance of all index and non-index lesions, and no new lesions. Partial response (PR): decrease in index lesions of 50% or greater in a sum of the products of diameters (SPD) relative to baseline, and no new lesions. Stable Disease (SD): Does not meet criteria for CR or PR, in the absence of PD in index lesions and no change or any change with persistence of one or more non-index lesions, and no new lesions. Progressive Disease (PD): At least 25% increase in SPD relative to nadir in index lesions and unequivocal progression of non-index lesions, along with new lesions or no new lesions; or PD: new lesions with any response with index or non-index lesions. Not Evaluable: Response cannot be determined.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||participants|||Number
1336267|NCT01990859|Secondary|Number of Participants With Renal Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Renal parameter=Creatinine. The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.|||participants|||Number
1336268|NCT01990859|Secondary|Number of Participants With Liver Function Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Liver Function parameters included: alanine aminotransaminase (ALT), aspartate aminotransferase (AST), Total Bilirubin, and Alkaline Phosphatase (Alk Phos). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.|||participants|||Number
1336269|NCT01990859|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Hematology parameters included: White Blood Cell Count (WBC), Absolute Neutrophil Count, Platelet Count, Hemoglobin, and Lymphocyte Count (absolute). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.|||participants|||Number
1336270|NCT01990859|Secondary|Number of Participants Who Died - All Treated Participants|Total number of deaths that occurred in all treated participants by study completion are reported.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||participants|||Number
1336271|NCT01990859|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related.|Day 1 to 90 Days after the last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||participants|||Number
1336294|NCT01990794|Secondary|Total Iron Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||µg/dL||Standard Deviation|Mean
1336272|NCT01990859|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).|Day 1 to 90 Days after the last dose, up to May 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized. Data up to May 2014 included.|||participants|||Number
1336273|NCT01990794|Secondary|Changes in Neurological Function (Velocity)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||m/s||Standard Deviation|Mean
1336274|NCT01990794|Secondary|Changes in Neurological Function (Sural Sensory Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||Sural Sensory Amplitude (µV)||Standard Deviation|Mean
1336275|NCT01990794|Secondary|Changes in Visual Function (Mean Deviation and PSD)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion||||dB||Standard Deviation|Mean
1336276|NCT01990794|Secondary|Changes in Visual Function (VFI)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion||||VFI (%)||Standard Deviation|Mean
1336277|NCT01990794|Secondary|Changes in Visual Function (Cup Volume)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion||||mm^3||Standard Deviation|Mean
1336278|NCT01990794|Secondary|Changes in Visual Function (Average C:D Ratio)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||ratio||Standard Deviation|Mean
1336279|NCT01990794|Secondary|Changes in Visual Function (Average RNFL Thickness)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||Average RNFL thickness (µm)||Standard Deviation|Mean
1336280|NCT01990794|Secondary|Changes in Cardiac Function (LA Volume Index)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||LA volume index (mL/m^2)||Standard Deviation|Mean
1336281|NCT01990794|Secondary|Changes in Cardiac Function (LVEF)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||LVEF (2D est) (%)||Standard Deviation|Mean
1336282|NCT01990794|Primary|Cobalt Serum Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation|||µg Co/L||Standard Deviation|Mean
1336283|NCT01990794|Secondary|Cobalt Urine Concentrations After Cessation of Cobalt Supplementation|A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.|After cobalt supplementation|"Participants that completed three months of cobalt supplementation and volunteered to do additional urine collections after stopping cobalt supplementation. n represents the number of urine samples analyzd at each time point."|||µg/L||Standard Deviation|Mean
1336285|NCT01990794|Secondary|Glucose Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||mg/dL||Standard Deviation|Mean
1336286|NCT01990794|Secondary|Triglyceride Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation|||mg/dL||Standard Deviation|Mean
1336287|NCT01990794|Secondary|Total Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation|||mg/dL||Standard Deviation|Mean
1336288|NCT01990794|Secondary|HDL Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation|||mg/dL||Standard Deviation|Mean
1336289|NCT01990794|Secondary|Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||U/L||Standard Deviation|Mean
1336290|NCT01990794|Secondary|Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||U/L||Standard Deviation|Mean
1336291|NCT01990794|Secondary|Creatinine Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||mg/dL||Standard Deviation|Mean
1336292|NCT01990794|Secondary|Creatine Creatine Kinase–Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||ng/mL||Standard Deviation|Mean
1336293|NCT01990794|Secondary|Ferritin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||ng/mL||Standard Deviation|Mean
1336584|NCT01986946|Secondary|Number of Participants With Adverse Events Related to the Study|Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.|6-week Follow up Visit||||participants|||Number
1336295|NCT01990794|Secondary|T4 Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation.Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||ng/dL||Standard Deviation|Mean
1336296|NCT01990794|Secondary|Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||mIU/L||Standard Deviation|Mean
1336297|NCT01990794|Secondary|Albumin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||g/dL||Standard Deviation|Mean
1336298|NCT01990794|Secondary|Protein Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||g/dL||Standard Deviation|Mean
1336299|NCT01990794|Secondary|Hematocrit Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||Percentage||Standard Deviation|Mean
1336300|NCT01990794|Secondary|Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||million cells/µL||Standard Deviation|Mean
1336301|NCT01990794|Secondary|White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||thousand cells/µL||Standard Deviation|Mean
1336302|NCT01990794|Primary|Cobalt Whole Blood Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation|||µg Co/L||Standard Deviation|Mean
1336303|NCT01990794|Secondary|Changes in Neurological Function (Peroneal Motor Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||Peroneal Motor Amplitude (mV)||Standard Deviation|Mean
1336304|NCT01990794|Secondary|Changes in Visual Function|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||mm^2||Standard Deviation|Mean
1336306|NCT01990794|Secondary|Changes in Audiological Function|Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, ~day 45, ~day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||dB||Standard Deviation|Mean
1336307|NCT01990794|Secondary|Hemoglobin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||g/dL||Standard Deviation|Mean
1336308|NCT01990794|Secondary|Effects on the Immune System|Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and >8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).|0 weeks and three months|Participants that completed three months of cobalt supplementation|||units on a scale: stimulation index (SI)||Standard Deviation|Mean
1336309|NCT01990794|Secondary|Albumin Bound Cobalt Fraction in Serum|The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.|Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers|Analysis was carried out on the first 12 participants of the study|||percentage of total blood cobalt||Standard Deviation|Mean
1336310|NCT01990742|Other Pre-specified|Number of Nursing Home Residents in Moderate-to-severe Pain|Presence of moderate-to-severe pain within 6 months of the date of death, among decedents cared for in the enrolled nursing homes. The verbal descriptor pain scale, where the resident is asked to rate the intensity of their worst pain in the last five day was most often used, where 0 = no pain, 1 = mild pain , 2 = moderate pain, 3 = severe pain, 4 = very severe pain, and 9 = unable to answer. Lower numbers (0 or 1 ) on the scale are preferred, and a lower percentage of residents reporting pain intensity in the moderate or higher ranges is a better outcome. The verbal descriptor scale can be shared with elders verbally, as the name implies, or by asking the resident to point to a setting on a visual thermometer with these word choices.|up to 6 months prior to death|Decedents cared for in assigned nursing home facilities for whom data on pain was available|||Participants|||Count of Participants
1336311|NCT01990742|Secondary|Number of Hospital Transfers Among Nursing Home Decedents|Number of hospitalizations in the last 90 days of life among decedents being cared for in the enrolled nursing homes|The last 90 days of life|Decedents with data on hospitalizations in the last 90 days of life|||Mean number of hospitalizations||Standard Deviation|Mean
1336312|NCT01990742|Primary|Hospital Site of Death: Number of Decedents Cared for in an Enrolled and Assigned NH Facility, Who Were Transferred to a Hospital and Died in the Hospital During the Study Period|This outcome measure, Hospital Site of Death, assesses whether death occured in a nursing home or in a hospital following transfer from the nursing home, among nursing home residents who were cared for in an enrolled facility.|1 year|Nursing home residents cared for in an assigned facility, who died during the study timeframe|||Participants|||Count of Participants
1336313|NCT01990703|Secondary|Time to Lactogenesis Stage 2|To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.|First 5 days after birth||||Hours||Standard Deviation|Mean
1336314|NCT01990703|Primary|Breastfeeding Continuation Rates at 8 Weeks Postpartum|To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.|8 weeks postpartum|147 Early IUD Insertion participants at baseline drops to 112 at 8 weeks due to exclusions for medical complications (n=15), inability to provide immediate IUD (n=7) and loss to follow up (n=13). In the Standard Insertion group 138 at baseline drops to 102 at 8 weeks with medical comps (n=11), failure to receive IUD (n=24), and 1 loss to follow up.|||Participants|||Count of Participants
1336315|NCT01990677|Other Pre-specified|Proportion of Patients Having a Reduction in Subfoveal Fluid on OCT Measurement|Placebo versus eplerenone acute CSCR patients will be measured at month 1 and placebo versus eplerenone chronic cscr patients will be measured at month 2.|Baseline and Month 2|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.|||Participants|||Count of Participants
1336316|NCT01990677|Secondary|Mean Change in Subfoveal Fluid Height Based on OCT Measurement|Placebo versus eplerenone chronic CSCR patients will be measured at month 2.|Baseline and Month 2|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.|||microns||Standard Deviation|Mean
1336317|NCT01990677|Primary|Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.|Placebo versus eplerenone chronic cscr patients will be have sub-foveal fluid measured at month 2.|Baseline and 2 months|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.|||microns||Standard Deviation|Mean
1336318|NCT01990664|Primary|Proportion of Successfully Re-fitted Subjects|Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.|4 weeks|The analysis population includes all subjects who have completed all study visits without a major protocol deviation.|||percentage of Subjects|||Number
1336319|NCT01990560|Secondary|State Trait Anxiety Inventory (STAI)|Change in Quality of Life - as assessed by the State Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored and averaged. Total scores range from 20 to 80, with higher scores correlating with greater anxiety.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1336320|NCT01990560|Secondary|Quality of Life|Change in Quality of Life as assessed by the Beck Depression Inventory. a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1336321|NCT01990560|Secondary|Hospital Anxiety and Depression Scale (HADS)|Change in Quality of Life as assessed by the Hospital Anxiety and Depression Scale (HADS). Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1336322|NCT01990560|Secondary|Nottingham Health Profile (NHP)|Change in Quality of Life as assessed by the Nottingham Health Profile (NHP) which is a patient reported questionnaire to measure a patient's view of their own health status. There are 6 sections (Energy level, Pain, Emotional Reaction, Sleep, Social Isolation, and Physical Abilities. All questions have only yes/no answer options and each section score is weighted so that the possible score range for any section is 0-100. The higher the score, the greater the number and severity of problems.|Baseline and 6 months||||units on a scale||Inter-Quartile Range|Mean
1336323|NCT01990560|Secondary|CushingQoL|Change in Quality of Life - as assessed by the Cushing’s Quality of Life questionnaire (CushingQoL). Patient completed questionnaire, 12 items, each scored on a 5 point score, resulting in a score of 12 (worst) to 60 (best) where higher scores indicate more favorable QOL.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1336324|NCT01990560|Secondary|Weight|Change in metabolic syndrome as assessed by weight|Baseline and 6 months|one participant had data missing at 6 months|||kg||Standard Deviation|Mean
1336325|NCT01990560|Secondary|Fasting Lipid Profile|Change in metabolic syndrome as assessed by fasting lipid profile which includes Low-density lipoproteins ( LDL), High-density lipoproteins (HDL), and Triglycerides (Trigs) levels, and total cholesterol which is the sum of HDL plus LDL and 20% of trigs.|Baseline and 6 months|one participant data missing at 6 month|||mg/dL||Standard Deviation|Mean
1336326|NCT01990560|Secondary|Body Mass Index (BMI)|Change in metabolic syndrome as assessed by BMI|Baseline and 6 months||||kg/m2||Standard Deviation|Mean
1336327|NCT01990560|Secondary|Waist Circumference|Change in metabolic syndrome as assessed by waist circumference|Baseline and 6 months||||cm||Standard Deviation|Mean
1336328|NCT01990560|Primary|HOMA-IR|Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, HOMA-IR (a validated assessment of insulin resistance). HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.|Baseline and 6 months|one participant on insulin. another participant had data missing at 6 months.|||HOMA-IR score||Standard Deviation|Mean
1336329|NCT01990560|Primary|A1C Level|Change in hyperglycemia assessed by HbA1c, also known as glycated hemoglobin|Baseline, 3 months, and 6 months||||percentage of red blood cells||Standard Deviation|Mean
1336330|NCT01990534|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers.|Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 12.2 months)|Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.|||participants|||Number
1336331|NCT01990534|Secondary|Monomethyl Auristatin E (MMAE) Serum Concentrations|Blood samples were collected and tested for MMAE serum concentrations.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."|||pg/mL||Standard Deviation|Mean
1336332|NCT01990534|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
1336333|NCT01990534|Secondary|Antibody-drug Conjugate (ADC) Serum Concentrations|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"Pharmacokinetic (PK) evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
1338875|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 7|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 7|Patients who have trough concentration data at Day 7|||μg/mL||Standard Deviation|Mean
1336334|NCT01990534|Secondary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 12.2 months)|Safety population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.|||participants|||Number
1336335|NCT01990534|Secondary|Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe.|From first dose through 30 days after the last dose of study medication [Up to 12.2 months, except for peripheral neuropathy (PN), all PN events will be followed for all changes in severity until resolution to baseline or study closure (Up to 24 months)]|Safety population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.|||participants|||Number
1336336|NCT01990534|Secondary|Percentage of Participants Who Received Stem Cell Transplantation (SCT)||Baseline up to EOS (Up to 24 months)|ITT population included all participants who were enrolled in the study.|||percentage of participants|||Number
1336337|NCT01990534|Secondary|Overall Survival (OS)|OS is the time in months from start of study treatment to date of death due to any cause.|Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant up to data cut-off: 24 March 2016 (approximate median follow-up 16.6 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.|||months||95% Confidence Interval|Median
1336338|NCT01990534|Secondary|Duration of Complete Remission (CR)|Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|From first documented response until disease progression (Up to 24 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the patient is known to be alive, including study closure.|||months||95% Confidence Interval|Median
1336339|NCT01990534|Secondary|Complete Remission Rate|Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease.|Baseline until disease progression, death or EOS (Up to 24 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.|||percentage of participants||95% Confidence Interval|Number
1336340|NCT01990534|Secondary|Progression Free Survival (PFS)|PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first.|Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to data cut-off: 24 March 2016 (approximate median follow-up 6.9 months)|ITT population included all participants who were enrolled in the study. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.|||months||95% Confidence Interval|Median
1336341|NCT01990534|Secondary|Duration of Response (DOR)|DOR is defined as the time in months from the date of first documentation of a CR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|From first documented response until disease progression (Up to 24 months)|ITT population included all participants who were enrolled in the study. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better.|||months||95% Confidence Interval|Median
1336342|NCT01990534|Primary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Baseline until disease progression, death or end of study (EOS) (Up to 24 months)|Intent-to-Treat (ITT) population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
1336343|NCT01990339|Secondary|Frequency of Adverse Events (Adverse Drug Reactions)|Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported.|4 Weeks|Safety analysis set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription were also excluded.|||percentage of participants|||Number
1336344|NCT01990339|Primary|Subjective Symptom Improvement Rate|Subjective symptoms were evaluated as “Disappeared,” “Improved,” “No change,” “Worsened,” or “Unclear.” These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of “Disappeared” + “Improved”) was calculated for each symptom. The percentage of participants with Improvement by symptom was reported.|Start of treatment and Week 4|Efficacy set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription and 861 patients whose questionnaires were not reviewed at either Week 2 or Week 4 were also excluded.|||percentage of participants|||Number
1336345|NCT01990313|Primary|Sample Beta Entropy|Sample entropy is a measure of estimated conditional predictability, calculated within a frequency range of a patient's local field potential. Freezers are subjects who have clinical history of freezing of gait symptoms and/or if the subject displayed freezing behavior pre-operatively or during the in-study gait tasks relative to non-freezers, those who have never experienced freezing of gait. We measured sample beta (13-30 Hz) entropy in subjects' local field potential. Higher values of sample entropy indicate lower estimated conditional predictability. Testing occurred over one day, at a range of approximately 1 month to 7 months post DBS device implantation.|1 day|6 participants excluded; 3 due to tremor which may alter neural signal, 2 didn't have adequate amount of neural signal for analysis, 1 was lost to follow-up|||Sample Entropy||Standard Deviation|Mean
1336346|NCT01990313|Primary|Change in Resting State Beta Band Power Over Time|We compared the beta band (13-30 Hz) power in the neural signal at the initial programming visit (baseline) and at the 12 month follow-up visit (1 year) after turning off deep brain stimulation therapy. Beta band power is normalized to average beta band power at the initial programming visit. Using a linear mixed model for repeated measures over time, regression beta coefficient was obtained to determine if beta power changed significantly between the initial programming and the 12 month follow-up visit.|Baseline and 1 Year|2 subjects excluded; 1 lost to follow-up, 1 had ECG artifact in neural signal|||regression beta coefficient|||Number
1336347|NCT01990261|Secondary|Overall Survival According to Prior Chemotherapy Treatment.|Prior chemotherapy treatment is presented as reported by the investigators.|Up to 12 months|Analysis was performed on all enrolled participants.|||days||Standard Error|Mean
1336348|NCT01990261|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 12 months|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
1336349|NCT01990261|Secondary|Overall Survival (OS)|OS is defined as time from first administration of study drug until death from any cause.|Up to 12 months|Analysis was performed on all enrolled participants.|||days||Standard Error|Mean
1336350|NCT01990261|Primary|Progression Free Survival (PFS) at Month 12|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 12 months)|Analysis was performed on all enrolled participants.|||days||95% Confidence Interval|Median
1336351|NCT01990261|Primary|Progression Free Survival (PFS) at Month 6|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 6 months)|Analysis was performed on all enrolled participants.|||days||95% Confidence Interval|Median
1336352|NCT01990261|Primary|Survival Rate at Month 12||Month 12|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
1336353|NCT01990261|Primary|Survival Rate at Month 6||Month 6|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
1336354|NCT01989793|Secondary|Number of Participants Experiencing Any Amount of Decrease in Frailty|Number of participants experiencing any amount of decrease in frailty score from baseline to Week 24 (i.e., improvement in frailty status)|from baseline to 24 weeks|Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.|||Participants|||Count of Participants
1336355|NCT01989793|Secondary|Number of Participants Experiencing Any Amount of Decrease in Frailty|Number of participants experiencing any amount of decrease in frailty score from baseline to Week 16 (i.e., improvement in frailty status)|from baseline to 16 weeks|Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.|||Participants|||Count of Participants
1336356|NCT01989793|Secondary|Number of Participants Experiencing Any Amount of Decrease in Frailty|Number of participants experiencing any amount of decrease in frailty score from baseline to Week 8 (i.e., improvement in frailty status)|from baseline to 8 weeks|Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.|||Participants|||Count of Participants
1336357|NCT01989793|Primary|Fatiguability|"Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.~Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to that of the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis."|Week 24|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||percentage of work||Standard Deviation|Mean
1336407|NCT01988857|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 to Day 30)||||Participants|||Count of Participants
1336358|NCT01989793|Primary|Fatiguability|"Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.~Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to that of the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis."|Week 16|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||percentage of work||Standard Deviation|Mean
1336359|NCT01989793|Primary|Fatiguability|"Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.~Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to the total work in the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis."|Week 8|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||percentage of work||Standard Deviation|Mean
1336360|NCT01989793|Primary|Change From Baseline in Isokinetic Strength|"Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).~The change in strength between baseline and week 24 (i.e., baseline minus week 24) was the outcome of the analysis. A negative number indicates a decrease in strength from week 0 to week 24."|Baseline to Week 24|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||Newton||Standard Deviation|Mean
1336361|NCT01989793|Primary|Change From Baseline in Isokinetic Strength|"Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).~The change in strength between baseline and week 16 (i.e., baseline minus week 16) was the outcome of the analysis. A negative number indicates decrease in strength from week 0 to week 16."|Baseline to Week 16|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||Newton||Standard Deviation|Mean
1336362|NCT01989793|Primary|Change From Baseline in Isokinetic Strength|"Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).~The change in strength between baseline and week 8 (i.e., baseline minus week 8) was the outcome of the analysis. A negative number indicates that there was a decrease in isokinetic strength from week 0 to week 8."|Baseline to Week 8|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||Newton||Standard Deviation|Mean
1336363|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 6 month diameter)/6 month diameter × 100.|6 months||||percentage of brachial artery diameter||Standard Deviation|Mean
1336364|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 3 month diameter)/3 month diameter × 100.|3 months||||percentage of brachial artery diameter||Standard Deviation|Mean
1336365|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline||||percentage of brachial artery diameter||Standard Deviation|Mean
1336366|NCT01989676|Secondary|Neutralizing Antibodies (Nab) Incidence at Cycle 1 Day 1 Prior to Treatment: Safety Population|Human serum samples testing positive for the presence of ADA (anti-PF-05280014 or anti-trastuzumab-EU) were analyzed for the presence or absence of NAb (neutralizing anti-PF-05280014 or neutralizing anti-trastuzumab-EU antibodies) following a tiered approach using screening and titer determination. All samples at baseline (prior to treatment) or post-treatment were taken prior to dosing. All participants with the exception of 1 participant in the trastuzumab-EU group tested negative for ADA (titer <1.00) from Cycle 1, Day 1 post-treatment through Cycle 17, Day 1. The corresponding NAb result for this Cycle 17, Day 1 ADA positive sample was not yet available; thus, not reported. The number of participants at Baseline (prior to treatment) with a positive NAb sample (titer≥1.48) is provided.|Available data from Baseline to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|Safety population was used for analysis, including all participants who received at least 1 dose of study drug. “Number of participant analyzed” refers to number of participants included in the evaluated for ADA at each visit.|||Participants|||Number
1336367|NCT01989676|Secondary|Anti-Drug Antibodies (ADA) Incidence: Safety Population|Two sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) immunoassays, 1 for detecting antibodies against PF-05280014 and the other for detecting antibodies against trastuzumab, were used to analyze ADA samples. Serum samples were first screened for ADA. Any samples that were positive in the screening assay were further analyzed to confirm the positive result and determine the antibody titers. All samples were taken prior to dosing. The number of participants with a positive sample (titer≥1.0) is provided.|Available data from Baseline through Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|Safety population was used for analysis, including all participants who received at least 1 dose of study drug. “Number of participants analyzed” refers to number of participants included in the evaluated for ADA at each visit.|||Participants|||Number
1336368|NCT01989676|Secondary|Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population|Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.|Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
1336369|NCT01989676|Secondary|Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population|Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific ELISA.|Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
1336370|NCT01989676|Secondary|Serum Peak (1 Hour Post End of Infusion) Concentration of Trastuzumab-EU at Selected Cycles: PK Population|Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.|Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
1336371|NCT01989676|Secondary|Serum Peak (1 Hour Post End of Infusion) Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population|Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific enzyme-linked immuno-sorbent assay (ELISA).|Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
1336372|NCT01989676|Secondary|One-year Survival Rate: ITT Population|One-year survival rate was analyzed based on the time from date of randomization to the date of death due to any cause while the participant was on the study. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox’s proportional hazards model.|From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.|The ITT population was defined as all participants who were randomized to study drug.|||Months||95% Confidence Interval|Median
1336373|NCT01989676|Secondary|Duration of Response (DOR) Per Central Radiology Assessments: ITT Population|DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD, or to death due to any cause in the absence of documented PD, based on the assessments of the central radiology review in accordance with RECIST 1.1. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox’s proportional hazards model.|From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.|The ITT population was defined as all participants who were randomized to study drug.|||Months||95% Confidence Interval|Median
1336374|NCT01989676|Secondary|One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population|One (1)-year PFS rate was analyzed based on the time from date of randomization to first documentation of progressive disease (PD), or death due to any cause in the absence of documented PD, based on the assessments of the central radiology review in accordance with RECIST 1.1. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox’s proportional hazards model.|From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.|The ITT population was defined as all participants who were randomized to study drug.|||Months||95% Confidence Interval|Median
1336375|NCT01989676|Primary|Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population|ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size [short axis <10 mm]) or partial response (PR, ≥30% decrease from Baseline of the sum of diameters of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33±14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.|From the date of randomization until the cutoff date of 24 August 2016 when all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit.|The ITT population was defined as all participants who were randomized to study drug.|||Percentage of participants||95% Confidence Interval|Number
1336376|NCT01989572|Secondary|5-year Recurrence Free Survival Rate|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||percentage of participants||95% Confidence Interval|Number
1336585|NCT01986946|Secondary|Number of Participants With Events of Special Interest|Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.|Post-operative Day 30|Data not collected||||||
1336377|NCT01989572|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||percentage of participants||95% Confidence Interval|Number
1336378|NCT01989572|Secondary|Recurrence Free Survival in HLA-A2 Positive Patients|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all HLA-A2 positive patients|||months||95% Confidence Interval|Median
1336379|NCT01989572|Secondary|Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15|all HLA-A2 positive patients|||months||95% Confidence Interval|Median
1336380|NCT01989572|Primary|Recurrence Free Survival|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||months||95% Confidence Interval|Median
1336381|NCT01989572|Primary|Overall Survival|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||months||95% Confidence Interval|Median
1336382|NCT01989455|Secondary|Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of oral deferiprone. Note: All subjects in the 1000 mg cohort received active product, including the 2 who had received placebo for the intravenous infusion.|From dosing until 24 hours post-dose|The safety population included all subjects who received study product.|||participants|||Number
1336383|NCT01989455|Secondary|Absolute Bioavailability of Deferiprone|The pharmacokinetic profile was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg*h/mL||Standard Deviation|Mean
1336384|NCT01989455|Secondary|Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone|Cmax was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg/mL||Standard Deviation|Mean
1336385|NCT01989455|Primary|Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.|From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferiprone|The safety population included all subjects who received study product.|||participants|||Number
1336386|NCT01989455|Primary|The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Standard Deviation|Mean
1336387|NCT01989455|Primary|Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg*h/mL||Standard Deviation|Mean
1336406|NCT01988922|Primary|The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.|Ketamine metabolism, measured as the plasma norketamine/ketamine AUC ratio in CYP2B6*6 carriers (CYP2B6*6 hetero or homozygotes) compared to the wild-type CYP2B6*1/*1 genotype Ketamine, norketamine, and dehydronorketamine concentrations in plasma and urine were determined by enantioselective HPLC tandem mass spectrometry, using solid phase extraction, based on a modification of a published method.|up to 24 hours|3 genotype groups, metabolism measured for both R- and S-ketamine|||ng/ml*hr||Standard Deviation|Mean
1336388|NCT01989455|Primary|Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Full Range|Median
1336389|NCT01989455|Primary|Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval||||μg/mL||Standard Deviation|Mean
1336390|NCT01989195|Secondary|Heart Rate: SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.~Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)||||Heart Rate change in beats per minute||Standard Deviation|Mean
1336391|NCT01989195|Secondary|Significant Cardiovascular Event|Hospitalization and procedures for chest pain, arrhythmias, and all-cause mortality|1 year||||participants|||Number
1336392|NCT01989195|Secondary|SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"QRS Duration: SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.~Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)||||Change in QRS Duration in milliseconds||Standard Deviation|Mean
1336393|NCT01989195|Primary|COMPARISON OF MYOCARDIAL INFARCTION SIZE MEASUREMENTS USING INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) OR DELAYED GADOLINIUM ENHANCED MRI (DEMRI)|Measured as percentage of myocardial injury volume to the total left ventricular myocardial volume|Day 1 (1 MRI)||||percentage of infarct to Left Ventricle||Standard Deviation|Mean
1336394|NCT01989169|Primary|Maximum Plasma Concentration (Cmax) of Midazolam|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
1336395|NCT01989169|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/ml||Standard Deviation|Mean
1336396|NCT01989169|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
1336397|NCT01989156|Primary|Levels of Carboxyhemoglobin (COHb)|Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5, for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||% of saturation of hemoglobin||95% Confidence Interval|Geometric Mean
1336398|NCT01989156|Primary|Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL)|Concentrations measured in urine, adjusted for creatinine, at Day 90 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|90 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Geometric Mean
1336399|NCT01989156|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Geometric Mean
1336400|NCT01989156|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||ng/mg creat||95% Confidence Interval|Geometric Mean
1336401|NCT01989156|Primary|Concentration of Monohydroxybutenylmercapturic Acid (MHBMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Geometric Mean
1336408|NCT01988857|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Days 0-30) post vaccination period||||Participants|||Count of Participants
1336409|NCT01988857|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 4 days (Days 0-3) post vaccination period||||Participants|||Count of Participants
1336410|NCT01988857|Primary|Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 4 days (Days 0-3) post vaccination period||||Participants|||Count of Participants
1336411|NCT01988662|Primary|Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent|Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.|Change from baseline at Month 3|Full Analysis Set (FAS): The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||Percent change||Standard Error|Least Squares Mean
1336412|NCT01988662|Secondary|Number of Patients With Ocular and Systemic Adverse Events|The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).|Day 1 to day 85|Safety (SAF) analysis set: The SAF analysis set included all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.|||Participants|||Number
1336413|NCT01988662|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time|"CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area.~Change from baseline calculated as observed post-baseline - baseline value."|Baseline, month 1, month 2, month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||micrometers||Standard Deviation|Mean
1336414|NCT01988662|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time|BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters. An increase in score indicates an improvement in acuity. Change from baseline calculated as observed post-baseline value - baseline value.|Baseline, month 1, month 2, month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||Letter||Standard Deviation|Mean
1336415|NCT01988662|Secondary|Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime|VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.|pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3|FAS|||pearson correlation coefficient||95% Confidence Interval|Number
1336416|NCT01988662|Secondary|Percent Change From Baseline in Plasma VEGF Level Overtime|Plasma VEGF measurement performed at all visits and compared to baseline level|Change from baseline up to month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||Percent change||Standard Error|Least Squares Mean
1336417|NCT01988415|Primary|Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity|Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity|3 Months|The analysis population was all evaluable eyes.|||percentage of eyes|Participants||Number
1336418|NCT01988415|Primary|Mean Postoperative Spherical Aberration|Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.|3 months|The analysis population was all evaluable eyes.|||µm|Participants|Standard Deviation|Mean
1336419|NCT01988402|Secondary|Serum Uric Acid Level|Blood test (serum) for uric acid level|day 28||||mg/dl||Standard Error|Mean
1336420|NCT01988402|Secondary|Physician Global Assessment of Gout Activity at Day 28|Physician rated gout activity is measured on a Likert scale 0-10.|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported||||units on a Likert scale||95% Confidence Interval|Mean
1336421|NCT01988402|Secondary|Pain Day 28|Patient rated pain on a Likert pain score of 0-10|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported||||units on a Likert scale||95% Confidence Interval|Mean
1336422|NCT01988402|Primary|Resolution of the Acute Gout Attack|The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack|1-28 Days||||days||Standard Deviation|Mean
1336575|NCT01987219|Primary|Change From Baseline of Forced Vital Capacity|FVC is a measure of the amount of air exhaled, and is measured in liters of air per second. The percentage in the change in the amount of air exhaled from baseline, measured in liters of air per second. Increase in the percentage of air exhaled from baseline indicates improvement in respiratory function.|Pre and 30 minutes post study drug administration|Per protocol|||percentage change from baseline||Standard Deviation|Mean
1336423|NCT01988129|Secondary|Change Firefighters’ and Families’ Job Satisfaction and Ability to Cope With Extended Work Hours|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters’ and families’ job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.|Baseline to 12 months|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters’ and families’ job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.||||||
1336424|NCT01988129|Secondary|Change in Firefighters’ Health, as Determined by General Health Indices;|"The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~A higher health index is indicative of better health. We assessed general health with the question ‘ In general, would you say your health is Excellent/Very good/Good/Fair/Poor?’ and coded the answers from 5-1, respectively."|Baseline to 12 months|Within-subject pre- versus post-study. Only 97/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||units on a scale||Standard Deviation|Mean
1336425|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic|"A lower number of times reported sleeping while stopped in traffic is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping while stopped in traffic is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 82/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
1336426|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving|"A lower number of times reported sleeping while driving is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported being sleepy while driving is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 81/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
1336427|NCT01988129|Other Pre-specified|Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire|Firefighters were instructed to attend a mandatory 30-min education training presentation as operations allowed. Following the education, firefighters were invited and encouraged to complete a voluntary sleep disorders screening questionnaire. This questionnaire used validated, self-report screening tools for Obstructive Sleep Apnea (OSA), moderate to severe insomnia, restless legs syndrome and shift work disorder. All of the respondents who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a local American Academy of Sleep Medicine-certified, partnering sleep clinics if they chose to follow-up. Participants were also free to seek medical follow-up elsewhere. Telephone calls were made to all high risk participants to ensure that they were aware of the results, and to facilitate clinic scheduling. Participants were asked to provide voluntary medical records release consent for tracking diagnoses.|Baseline (Study start)|A total of 431 firefighters completed the sleep disorders screening survey including 416 from the intervention stations and 15 who were temporarily assigned to duty in the intervention stations on the day of the survey. We did not consider these 15 firefighters as a separate population.|||participants|||Number
1336428|NCT01988129|Primary|Firefighters’ Performance, as Determined by Response Time Over 12 Months|"A lower response time is indicative of better performance.~Following detailed review of departmental procedures and records, we determined that ‘turn-out time’ was already very rapid and not considered an accurate measure of firefighters’ performance by the department. Similarly, ‘clearance time’ (time from the start until the end of the event), which could last for many hours, was also not considered an appropriate measure of firefighter’ performance in relation to sleep and alertness given the multiple factors, many of which are not under the control of the firefighters, that could affect clearance times. We therefore did not address this aim."|12 months|Following review of departmental records, we determined that ‘turn-out time’ and ‘clearance time’ were not appropriate measures of firefighter’ performance in relation to sleep and alertness given the multiple factors that could affect them. We therefore did not address this aim.||||||
1336429|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone|"A lower number of times reported sleeping on the telephone is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping on the telephone is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 88/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
1336450|NCT01988012|Primary|Change From Baseline in SDAI|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA and had a good correlation with the DAS28. The index was calculated using the following formula: SDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in mg/L. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336430|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings|"A lower number of times reported falling asleep during meetings is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping during meetings is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 27/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
1336431|NCT01988129|Secondary|Change in the Mean Total Sleep Time|"A higher total sleep time is indicative of better sleep. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for total sleep time is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey, and had at least 1 week of work scheduled in the 4 weeks prior to each survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 62/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Hours/week||Standard Deviation|Mean
1336432|NCT01988129|Primary|Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months|Fewer on-the-job injuries is indicative of better health. We assessed injuries cumulatively over 12 months. Injuries that triggered the filing of an official city government accident report as the result of following normal departmental procedures were included in this study.|12 months||||injury report/firefighter||Standard Deviation|Mean
1336433|NCT01988129|Primary|Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months|Fewer motor vehicle crashes is indicative of better health. We assessed motor vehicle crashes cumulatively over 12 months. Accidents were counted as any incident that resulted in the filing and review of a departmental Fleet Accident Report.|12 months||||incidents/firefighter||Standard Deviation|Mean
1336434|NCT01988129|Primary|Firefighters’ Health, as Determined by Number of ‘Sick’ Days Over 12 Months|We assessed 'sick days' cumulatively over 12 months in two ways from departmental payroll records; the number of 24-hour pay periods coded as 'sick' time per firefighter and the number of 24-hr pay periods coded as injury and disability per firefighter. Fewer sick days is indicative of better health.|12 months||||days/firefighter||Standard Deviation|Mean
1336435|NCT01988012|Secondary|Immunogenicity: Change From Week 1 in Soluble Interleukin-6 Receptor (sIL-6R) Levels|A positive change from Week 1 indicates an increase in sIL-6R levels.|Week 1, Week 12, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
1336436|NCT01988012|Secondary|Immunogenicity: Tocilizumab Levels||Week 12, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
1336437|NCT01988012|Secondary|Immunogenicity: Percentage of Participants With Anti-tocilizumab Antibodies|Reported is the percentage of participants positive for anti-tocilizumab antibodies in the confirmatory anti-tocilizumab antibody assay, which followed an initial anti-tocilizumab screen. Participants, who withdrew from the study|Baseline, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
1336438|NCT01988012|Secondary|Percentage of Participants Who Required Dose Modifications or Discontinued Study Due to AEs||Up to Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1336439|NCT01988012|Secondary|Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest (AESIs)|An AE is any untoward medical occurrence in a participant administered a drug and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not considered related to the drug. Preexisting conditions which worsen during a study are also considered as AEs. AESIs are AEs that occur in categories of special interest with regard to the benefit-risk profile and overall safety of a drug. The following nine categories of AESIs were identified for tocilizumab: 1) serious and/or medically significant infections, 2) myocardial infarction/acute coronary syndrome, 3) gastrointestinal perforations, 4) malignancies, 5) anaphylaxis/hypersensitivity reactions, 6) demyelinating disorders, 7) stroke, 8) serious and/or medically significant bleeding events, and 9) serious and/or medically significant hepatic events.|Up to Follow-up Week 32|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1336440|NCT01988012|Primary|Total Scores on Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS)|The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. HAS is a clinician-administered assessment to measure the severity of anxiety symptoms and consists of 14 items with a total score range from 0 to 56. A higher score indicates a worse outcome.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336461|NCT01987986|Primary|Investigator Global Assessment of Aesthetic Improvement|Investigators assessment of aesthetic improvement (I-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336576|NCT01986985|Primary|PET/MR Images Clinical Usefulness|Clinically relevant images are obtained|1 day|Subjects with images successfully collected using PET/ MR|||Participants|||Number
1336577|NCT01986946|Secondary|Wound Infection Rates||during hospitalization (approximately 3-8 days)|Data not collected||||||
1336441|NCT01988012|Primary|Change From Baseline in Patient Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 52. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. A positive change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336442|NCT01988012|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 (without any difficulty) to 3 (unable to do). The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336443|NCT01988012|Primary|Change From Baseline in Patient Pain VAS|Patient Pain VAS represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS scale from 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336444|NCT01988012|Primary|Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)|PGA VAS represents the participant’s overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS scale from 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336445|NCT01988012|Primary|Change From Baseline in Percentage of Participants on Tocilizumab Monotherapy|Participants were either on tocilizumab monotherapy or tocilizumab plus non-biologic disease modifying anti-rheumatic drugs (DMARDs). Reported here is the percentage of participants on tocilizumab monotherapy at baseline and the change from baseline at Week 24. A positive change from baseline at Week 24 indicates the percentage of participants, who discontinued DMARDs during the study.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1336446|NCT01988012|Primary|Change From Baseline in TJC and SJC|The number of tender joints (based on 68 joints) and swollen joints (based on 66 joints) were counted at each visit. TJC was determined by identifying the joints that were painful under pressure or to passive motion; no tenderness =0, tenderness =1. SJC was determined by identifying swelling; no swelling =0, swelling =1. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||joint count||Standard Deviation|Mean
1336447|NCT01988012|Primary|Percentage of Participants With Good to Moderate European League Against Rheumatism (EULAR) Response|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (</=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1336448|NCT01988012|Primary|Percentage of Participants Achieving 20%, 50% and 70% Improvement in American College of Rheumatology (ACR) Response Scores (ACR20, ACR50 and ACR70)|An ACR20 response requires at least 20% improvement compared to baseline in SJC (based on 66 joints) and TJC (based on 68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician’s global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) CRP in mg/L or ESR in mm/hr. ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity).|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1336449|NCT01988012|Primary|Change From Baseline in Disease Activity Score 28-Erythrocyte-Sedimentation Rate (DAS28-ESR)|The DAS28-ESR score is a measure of the patient’s disease activity calculated using the tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), patient’s global assessment (PGA) of disease activity based on visual analog scale (VAS) and the erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/hr). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total possible score ranged from 0 to 10. Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336451|NCT01988012|Primary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission and SDAI Low Disease Activity|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA and had a good correlation with the DAS28. The index was calculated using the following formula: SDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligram/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. An SDAI score of ≤ 3.3 represents clinical remission, a score of ≤ 11.0 represents low disease activity.|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1336452|NCT01988012|Primary|Change From Baseline in CDAI|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1336453|NCT01988012|Primary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Remission is defined as CDAI ≤2.8 and Low Disease Activity (LDA) is defined as 2.8< CDAI ≤10.|Week 24|The analysis population included those participants from the full analysis set (FAS) for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1336454|NCT01987986|Other Pre-specified|Subject Global Assessment of Aesthetic Improvement (C-GAIS)|Subjects's assessment of aesthetic improvement (C-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).|Day 73|All subjects who received at least one injection of study medication and had at least one post injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336455|NCT01987986|Other Pre-specified|Subject Global Assessment Cellulite (SGA-C)|Subjects assessed their cellulite based on a 5-point scale from -1 (slightly worse), 0 (same), 1 (slightly improved), 2 (moderately improved), to 3 (much improved) on Day 73|Day 73|All subjects who at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336456|NCT01987986|Other Pre-specified|Subject Satisfaction With Treatment Assessment (SCTA)|Subjects rated their treatment satisfaction at the Day 73 visit on a 5-point scale ranging from -2 (very dissatisfied) to +2 (very satisfied)|Day 73|All subjects who received at least one injection of study drug and had at least one post -injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336457|NCT01987986|Other Pre-specified|Subject-reported Cellulite Impact Scale (SR-CIS)-Change From Baseline|"Subjects were asked to answer 6 exploratory questions regarding the appearance of their cellulite on a scale of 0 to 10 with 0 representing not at all and 10 representing extremely. A SR-CIS total score was derived from these 6 questions with values varying from 0 (No negative impact) to 60 (Extreme negative impact). Change from baseline is Day 73 value minus baseline value; negative change reflects an improvement."|Baseline, Day 73|All subjects who received at least one injection and who had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336458|NCT01987986|Other Pre-specified|Subject Global Bother Assessment (SGBA)- Change From Baseline|Subjects rated their cellulite on a scale from 0 (not at all bothered) to 4 (extremely bothered). Change from baseline is Day 73 study visit value minus baseline value; negative change reflects an improvement in the amount the subject was bothered by cellulite; positive change reflects a worsening in the amount the subject is bothered by cellulite.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336459|NCT01987986|Other Pre-specified|Subject Cellulite Severity Item (CSI)-Change From Baseline|CSI scores ranged from 0 (no cellulite present), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). Change is Day 73 study visit rating minus baseline rating; negative values indicate a lessening in cellulite severity.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336460|NCT01987986|Other Pre-specified|Investigator Cellulite Severity Score (CSS) Total Score- Change From Baseline|The CSS is a photonumeric scale that was used to evaluate 5 morphologic features of cellulite; (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature including Nuernberger and Mueller. The severity of each feature is rated on a scale from 0 (none) to 3 (most severe). The CSS total score is the sum of the 5 cellulite features (range: 0 to 15, with higher scores corresponding to more severe cellulite). Change is Day 73 study visit rating minus baseline rating; negative values indicate improvement in cellulite.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
1336578|NCT01986946|Secondary|Length of Hospital Stay||during hospitalization (approximately 3-8 days)||||days||Standard Deviation|Mean
1336579|NCT01986946|Secondary|Number of Participants Readmitted to Hospital Within 30 Days of Surgery||Post-operative Day 30||||participants|||Number
1336462|NCT01987960|Secondary|Global Clinical Impression Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Period 2: Baseline to Week 12 (of randomized period)|Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done.|||Score||Standard Deviation|Mean
1336463|NCT01987960|Primary|PTSD Symptoms Using CAPS-2 Total Score|Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.|Period 2: Baseline to Week 12 (of randomized period)|Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done|||Score||Standard Deviation|Mean
1336464|NCT01987908|Secondary|Reduction in Sickle Cell-specific Complications||Throughout the study period (approximately 9 weeks)|Data not collected for this outcome measure. Study terminated early.||||||
1336465|NCT01987908|Secondary|Analgesic Use|Analgesic use assessed with pain levels by numerical pain rating scale (NPRS) and brief pain inventory (BPI).|Throughout the study period (approximately 9 weeks)|Data not collected for this outcome measure. Study terminated early.||||||
1336466|NCT01987908|Secondary|Brief Pain Inventory (BPI): Interference of Pain With Aspects of Life (General Activity) During Post-treatment Observation Period - Change From Baseline|"Participants rated the degree to which their pain interfered with various daily functions by using the BPI short form. Interference with general activity was rated on a scale from 0 (does not interfere) to 10 (completely interferes).~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period."|At baseline and Day 49 during the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
1336467|NCT01987908|Secondary|Brief Pain Inventory (BPI): Interference of Pain With Aspects of Life (General Activity) During Double-blind Treatment Period - Change From Baseline|"Participants rated the degree to which their pain interfered with various daily functions by using the BPI short form. Interference with general activity was rated on a scale from 0 (does not interfere) to 10 (completely interferes).~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
1336468|NCT01987908|Secondary|Brief Pain Inventory (BPI): Worst Pain Level in Last 24 Hours (Post-treatment Observation Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period."|At baseline and Day 49 during the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
1336469|NCT01987908|Secondary|Brief Pain Inventory (BPI): Worst Pain Level in Last 24 Hours (Double-blind Treatment Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
1336470|NCT01987908|Secondary|Brief Pain Inventory (BPI): Average Pain Level in Last 24 Hours (Double-blind Treatment Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
1336471|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28) - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the most recent value obtained on the last day of the double-blind dosing period (Day 28). Area under the curve (AUC) was computed using change from baseline (Day 28) in weekly average values at Day 35, Day 42 and Day 49.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||NPRS score*week||Standard Deviation|Mean
1336580|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 3|Participants who were evaluated for Delirium on Day 3|||participants|||Number
1336472|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28)|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the most recent value obtained on the last day of the double-blind dosing period (Day 28).~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||score on a scale||Standard Deviation|Mean
1336473|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1. Area under the curve (AUC) was computed using change from baseline in weekly average values at Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 and Day 49.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||NPRS score*week||Standard Deviation|Mean
1336474|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Baseline|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||score on a scale||Standard Deviation|Mean
1336475|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Double-blind Treatment Period - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1. Area under the curve (AUC) was computed using change from baseline in weekly average values at Day 7, Day 14, Day 21. and Day 28.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 7, Day 14, Day 21, and Day 28 assessments||||NPRS score*week||Standard Deviation|Mean
1336476|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Double-blind Treatment Period - Change From Baseline|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 7, Day 14, Day 21, and Day 28 assessments||||score on a scale||Standard Deviation|Mean
1336477|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.~Baseline was defined as the most recent value obtained on the last day of the double-blind treatment period.~Categories contain Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 35, 42, and 49 during the post-treatment observation period||||score on a scale||Standard Deviation|Mean
1336478|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Post-treatment Observation Period - Change From Baseline|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 35, 42, and 49 during the post-treatment observation period||||score on a scale||Standard Deviation|Mean
1336553|NCT01987479|Primary|Percentage of Participants With Adverse Events|An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.|Baseline up to Week 32|FAS population|||percentage of participants|||Number
1336479|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Double-blind Treatment Period - Change From Baseline|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period. No values available for placebo group for Day 28.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 7, 14, 21, and 28 during the double-blind treatment period||||score on a scale||Standard Deviation|Mean
1336480|NCT01987908|Secondary|Exercise Tolerance: Cardiopulmonary Exercise Test [CPET]|CPET was optional, based on capacity of participant to complete the test.|On last day of double-blind treatment period (Day 28)|Following an external review and report of CPET capabilities of the external service provider, all CPET testing was suspended and the decision made to not collect or analyze CPET data.||||||
1336481|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance on Day 49 of the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28)|Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.|On last day of double-blind treatment period (Day 28) and on Day 49 of the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||meters||Standard Deviation|Mean
1336482|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance on Day 49 of the Post-treatment Observation Period - Change From Baseline|"Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1."|Prior to dosing at baseline and on Day 49 of the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||meters||Standard Deviation|Mean
1336483|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance During the Double-blind Treatment Period - Change From Baseline|"Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 4, Day 7, Day 14 and Day 28||||meters||Standard Deviation|Mean
1336484|NCT01987908|Secondary|Body Weight - Change From Baseline|"A negative change in body weight denotes a weight decrease, a positive change in body weight denotes a weight increase.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 4, Day 7, Day 14, Day 21 and Day 28||||kg||Standard Deviation|Mean
1336485|NCT01987908|Secondary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Levels- Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1, Day 7, Day 14 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||pmol/L||Standard Deviation|Mean
1336486|NCT01987908|Secondary|Serum Ferritin Levels - Change From Baseline||At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||mircograms/L||Standard Deviation|Mean
1336487|NCT01987908|Secondary|C Reactive Protein Levels - Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||mg/L||Standard Deviation|Mean
1336488|NCT01987908|Secondary|LDH Isoform - Change From Baseline||Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28|Summary tables for this outcome measure were not done as baseline data missing. Study terminated early.||||||
1336489|NCT01987908|Secondary|Direct Bilirubin - Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo.|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14, Day 21 and Day 28||||mircomoles/L||Standard Deviation|Mean
1336490|NCT01987908|Secondary|Reticulocyte Percent- Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||percent||Standard Deviation|Mean
1336581|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 2|Participants who were evaluated for Delirium on Day 2|||participants|||Number
1336582|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 1|Only participants who had assessment for delirium are include in the analysis.|||participants|||Number
1336491|NCT01987908|Secondary|Hemoglobin Levels - Change From Baseline|"A clinical laboratory endpoint that reflects the amount of red blood cells present in the blood. Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 4, Day 7, Day 14, Day 21 and Day 28||||g/L||Standard Deviation|Mean
1336492|NCT01987908|Secondary|Lactate Dehydrogenase (LDH) Levels - Change From Baseline|"LDH levels were measured as a biomarker for intravascular hemolysis. The results are based on the LDH Total measurement. Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28||||U/L||Standard Deviation|Mean
1336493|NCT01987908|Secondary|Hematocrit Levels - Change From Baseline|"Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28||||L/L||Standard Deviation|Mean
1336494|NCT01987908|Secondary|Plasma Erythropoietin (EPO) Levels - Change From Baseline|"Erythropoietin (EPO) is a hormone produced by the kidney that promotes the formation of red blood cells by the bone marrow. EPO can be detected and measured in the blood.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||U/L||Standard Deviation|Mean
1336495|NCT01987908|Secondary|Oxygen Binding p50/p20 Value - Change From Baseline|"A measure of the ability of hemoglobin to bind oxygen. The p50 is the oxygen level at which 50% of the hemoglobin contains oxygen. The p20 is the oxygen level at which 20% of the hemoglobin contains oxygen. Baseline is defined as the most recent value obtained prior to start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|During the double-blind treatment period at baseline, Day 1, Day 4 and Day 7||||ratio||Standard Deviation|Mean
1336496|NCT01987908|Secondary|Resting Oxygen Saturation as Measured by Oximetry (SpO2) - Change From Baseline|"A measure of the amount of oxygen in the blood. Oxygen saturation was determined by pulse oximetry. A pulse oximeter was placed over a nail polish-free finger nail to determine peripheral oxygen saturation (SpO2).~Baseline was defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period. A mean change from baseline >0 indicates an increase in oxygen saturation, a mean change <0 indicates a decrease in oxygen saturation.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 4, Day 7, Day 14 and Day 28||||percent saturation||Standard Deviation|Mean
1336497|NCT01987908|Primary|PK: - Plasma AUC, Cmax, Tmax, and T1/2 of Aes-103 and Its Metabolite, HMFA - RBC Hemolysate AUC (0-8h), Cmax, Tmax, and T1/2 of Aes-103 - Percentage of Hemoglobin Bound to Aes-103|"Pharmacokinetic endpoints in the study protocol were as follows:-~Plasma Area under curve (AUC), Maximum plasma concentration (Cmax), time at which Cmax observed (Tmax), and terminal half-life (T1/2) of Aes-103 and its metabolite, 5-hydroxymethyl-2-furoic acid (HMFA)~red blood cell (RBC) hemolysate Area under curve between 0 and 8 hours (AUC [0-8h]), Cmax, Tmax, and T1/2 of Aes-103~Percentage of hemoglobin bound to Aes-103"|PK blood samples were to be taken within 10 minutes before dosing and 0.5, 1, 2, 4, and 6 hours after the first dose of study product on Days 1 and 7 and at the same time points on Day 28 (or early termination)|PK data were not determined as the assay collection method was found to be faulty rendering all samples unevaluable.||||||
1336498|NCT01987908|Primary|Number of Clinically Significant Observations of Vital Signs, 12-lead ECGs, Clinical Laboratory Assessments, and Physical and Neurological Examinations|Vital signs, 12-lead ECGs, clinical laboratory assessments, and physical and neurological examinations that were deemed clinically significant by the investigator in agreement with the sponsor study director.|Throughout the study period (approximately 9 weeks)|safety analysis dataset|||clinically significant observations|||Number
1336499|NCT01987908|Primary|Number of Participants With Sickle-Cell Disease-related Symptoms||Placebo lead-in period of 14 days (Day -14 to Day -1), double-blind treatment period of 28 days (Day 1 to Day 28) and post-treatment observation period of 21 days (Day 29 to Day 49)||||participants|||Number
1336500|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle-cell Specific Symptoms, During the Post-treatment Observation Period|Number of participants with adverse events (AEs) reported during the post-treatment observation period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Post-treatment observation period of 21 days (Day 29 to Day 49)||||participants|||Number
1336501|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle-cell Specific Symptoms, During the Placebo lead-in Period|Number of participants with adverse events (AEs) reported during the placebo lead-in period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Placebo lead-in period of 14 days (Day -14 to Day -1)||||participants|||Number
1336583|NCT01986946|Secondary|Total Post-operative Opioid Consumption||during hospitalization (approximately 3-8 days)||||oral morphine equivilant (mg)||Standard Deviation|Mean
1336502|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle Cell-specific Symptoms, During the Double-blind Treatment Period|Number of participants with adverse events (AEs) reported during the double-blind treatment period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Double-blind treatment period of 28 days (Day 1 to Day 28)||||participants|||Number
1336503|NCT01987895|Other Pre-specified|Recurrence Rate|Recurrence is defined as the occurrence of a new episode of diarrhea (> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.|Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)|Subjects from the modified intent-to-treat analysis set with clinical cure|||percentage of participants||95% Confidence Interval|Number
1336504|NCT01987895|Other Pre-specified|Sustained Cure Rate (SCR) in the Per-protocol Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
1336505|NCT01987895|Other Pre-specified|Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5|"ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having ‘Not Sustained Cure’ for the analysis.~ISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT)."|Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
1336506|NCT01987895|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
1336507|NCT01987895|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
1336508|NCT01987895|Secondary|Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores|CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms. The least squares means (LSM) are computed on the scores.|Day 1 (baseline) and Day 3|All subjects from the modified intent-to-treat population, excluding those who participated in the validation sub-study. No imputation of missing scores is performed prior to deriving response status. Subjects with missing values at baseline or at Day 3 are considered to be non-responders.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1336509|NCT01987895|Secondary|Kaplan-Meier Estimates for Resolution of Diarrhea|"Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment.~The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point."|Up to Day 10|The analyses were performed on the modified intention-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD|||KM estimate (%)||95% Confidence Interval|Number
1336510|NCT01987895|Secondary|Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
1336554|NCT01987453|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement"|Up to posttreatment Week 24|Full Analysis Set|||Percentage of participants|||Number
1336511|NCT01987895|Primary|Clinical Cure Rate (CCR) in the Per-protocol Population|Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (end-of-treatment + 2 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
1336512|NCT01987895|Primary|Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population|"Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT.~CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below."|Up to Day 12 on average (end-of-treatment + 2 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
1336513|NCT01987765|Primary|Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale|Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.|Baseline, 2 Weeks|Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis.|||Scores on a Scale||Standard Deviation|Mean
1336514|NCT01987765|Primary|Percentage of Patients Reporting Adverse Events|An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 10 Months|Safety Assessment Population: included all patients who completed the study.|||Percentage of Patients|||Number
1336515|NCT01987752|Primary|Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.|Baseline, Week 4|Efficacy Population included all participants who received study drug for > 4 weeks and had overall assessment data available.|||Percentage of participants|||Number
1336516|NCT01987752|Primary|Percentage of Participants Reporting Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 2.6 Years|Safety Population included all participants who received study drug.|||Percentage of participants|||Number
1336517|NCT01987583|Primary|Diastolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
1336518|NCT01987583|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.~Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month|||||||
1336519|NCT01987583|Primary|Systolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
1336520|NCT01987557|Secondary|Static Posturography (Balance/Postural Control)|A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.|||||||
1336521|NCT01987557|Secondary|Spatiotemporal Aspects of Gait|"Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined.~Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis.~Spotters are always present to ensure safety during this assessment."|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.|||||||
1336522|NCT01987557|Primary|Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)|"A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure.~The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment)."|Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined||||units on a scale (0-4)||Standard Deviation|Mean
1336523|NCT01987505|Secondary|Treatment Response Rate|Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: >/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.|4-6 weeks after the last dose of Induction (Up to approximately 8 months)|ITT population included all enrolled participants.|||percentage of participants|||Number
1336555|NCT01987453|Secondary|Change in HCV RNA From Baseline||Baseline to Week 8|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1336556|NCT01987453|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Baseline to Week 24|Full Analysis Set|||Percentage of participants|||Number
1336524|NCT01987505|Secondary|Disease-Free Survival (DFS)|DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|ITT population included all enrolled participants.|||months||95% Confidence Interval|Mean
1336525|NCT01987505|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of rituximab IV to death from any cause.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|ITT population included all enrolled participants.|||months||95% Confidence Interval|Mean
1336526|NCT01987505|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|ITT population included all enrolled participants.|||months||95% Confidence Interval|Mean
1336527|NCT01987505|Secondary|Event-Free Survival (EFS)|EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non–protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|Intent-to-Treat (ITT) population included all enrolled participants.|||months||95% Confidence Interval|Mean
1336528|NCT01987505|Secondary|Percentage of Participants With At Least One Serious Adverse Event (SAE)|SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
1336529|NCT01987505|Secondary|Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)|Grading of IIRRs was completed according to the CTCAE, version 4.0.|From start of treatment to end of treatment (up to 32 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
1336530|NCT01987505|Secondary|Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.|From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
1336531|NCT01987505|Primary|Percentage of Participants With Administration-Associated Reactions (AARs)|AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.|From start of treatment to end of treatment (up to 32 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
1336532|NCT01987479|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
1336533|NCT01987479|Secondary|Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records|A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period.|Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
1336557|NCT01987453|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||Percentage of participants|||Number
1336534|NCT01987479|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
1336535|NCT01987479|Secondary|Patient Pain VAS Scores|This assessment represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||mm||Standard Deviation|Mean
1336536|NCT01987479|Secondary|Patient Global Assessment of Disease Activity VAS Scores|Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||mm||Standard Deviation|Mean
1336537|NCT01987479|Secondary|Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)||Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. “n” = participants who were evaluable at specified timepoint.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1336538|NCT01987479|Secondary|Serum Levels of Tocilizumab||Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. “n” = participants who were evaluable at specified timepoint.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1336539|NCT01987479|Secondary|Percentage of Participants With Anti-Tocilizumab Antibodies||Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
1336540|NCT01987479|Secondary|Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs|Time to discontinuation or first dose reduction of corticosteroids or NSAIDs (weeks) = (Date of the first dose reduction or end date of corticosteroids or NSAIDs treatment - date of first drug intake of this study) + 1. Time to discontinuation or first dose reduction was based on the first occurring event (corticosteroid discontinuation or corticosteroid first dose reduction or NSAIDs discontinuation or NSAIDs first dose reduction, whichever occurred first).|Baseline up to Week 32|FAS population|||weeks||95% Confidence Interval|Median
1336541|NCT01987479|Secondary|Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons|Results are reported for percentage of participants who had corticosteroid dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).|From Week 16 and before Week 20; From Week 20 and before Week 24|FAS population|||percentage of participants|||Number
1336542|NCT01987479|Secondary|Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons|Results are reported for percentage of participants who had NSAIDs dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).|From Week 16 and before Week 20; From Week 20 and before Week 24|FAS population|||percentage of participants|||Number
1336543|NCT01987479|Secondary|Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|Number of swollen joints was determined by examination of 28 joints for SJC28 and 66 joints for SJC66 and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 for a SJC28 and 66 for a SJC66. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||swollen joints||Standard Deviation|Mean
1336544|NCT01987479|Secondary|Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|Number of tender joints was determined by examining 28 joints for TJC28 and 68 joints for TJC68, and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 for a TJC28 and 68 for a TJC68. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||tender joints||Standard Deviation|Mean
1336545|NCT01987479|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician’s global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
1336558|NCT01987453|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 Weeks|Safety Analysis Set|||Percentage of participants|||Number
1336559|NCT01987453|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Post-treatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug|||Percentage of participants|||Number
1336546|NCT01987479|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity .|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
1336547|NCT01987479|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline >0.6 to ≤1.2 with a DAS28 score >5.1, or any score with change from baseline ≤0.6, were assessed as non-responders.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
1336548|NCT01987479|Secondary|Percentage of Participants Achieving an ACR90 Response|A participant had an ACR90 response if there was at least a 90% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
1336549|NCT01987479|Secondary|Percentage of Participants Achieving an ACR70 Response|A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
1336550|NCT01987479|Secondary|Percentage of Participants Achieving an ACR50 Response|A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
1336551|NCT01987479|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response|A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
1336552|NCT01987479|Secondary|Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour [mm/hour]), and patient’s global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale [VAS] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR less than (<) 2.6 implied clinical remission.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1342702|NCT01910389|Secondary|Frequency of CV Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
1336563|NCT01987232|Other Pre-specified|Duration of Response|"Duration of response (DOR) was calculated for participants who achieved a confirmed CR or PR. defined as the time from first evidence of confirmed PR/CR to disease progression or death due to any cause. Median DOR was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored.~DOR was originally specified as a secondary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed, DOR was analyzed in phase 1b participants on an exploratory basis."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|Participants with a confirmed response of PR or CR.|||months||95% Confidence Interval|Median
1336564|NCT01987232|Other Pre-specified|Overall Response Rate|"The overall response rate (ORR) was defined as the percentage of participants for whom the best overall confirmed response was either complete response (CR) or partial response (PR) assessed by the investigator according to RECIST v1.1 criteria.~CR: Disappearance of all target and non-target lesions, no new lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1336565|NCT01987232|Other Pre-specified|Progression-free Survival|"Progression-free survival (PFS) was specified as a primary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed PFS was analyzed in phase 1b participants on an exploratory basis. PFS was defined as the time from the start of treatment to documented disease progression or death due to any cause, whichever occurred first. Disease progression was determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as at least a 20% increase in the size of target lesions (absolute increase ≥ 5 mm), unequivocal progression of existing non-target lesions, or any new lesions.~Median PFS was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.|||months||95% Confidence Interval|Median
1336566|NCT01987232|Secondary|Area Under Plasma Concentration-Time Curve - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants||||||
1336567|NCT01987232|Secondary|Time of Maximum Plasma Concentration - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants||||||
1336568|NCT01987232|Secondary|Maximum Plasma Concentration - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants||||||
1336569|NCT01987232|Secondary|Overall Survival (OS) - Phase 2|Overall Survival (OS) is defined as the time from randomization to the date of death. Overall survival was a specified secondary endpoint for the phase 2 portion of the study; since phase 2was not conducted, OS was not analyzed.|30 months|Participants enrolled in phase 2||||||
1336570|NCT01987232|Secondary|Number of Participants With Adverse Events (AEs)|"The severity of each adverse event was assessed using the NCI-CTCAE Version 4.03 according to the following:~Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated~Grade 2 – Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)~Grade 3 – Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL~Grade 4 – Life-threatening~Grade 5 – Fatal.~A serious AE is an AE that met one or more of the following criteria:~Death~Life-threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~A congenital anomaly/birth defect~Important medical events that required medical or surgical intervention to prevent one of the outcomes above."|From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1336571|NCT01987232|Primary|Number of Participants With Dose-limiting Toxicities|"The maximum tolerated dose (MTD) was defined as the highest dose level at which < 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as:~A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy. A grade 2 or higher neuropathy with pain was considered a DLT.~Grade 4 neutropenia: absolute neutrophil count (ANC) < 500 mm³, lasting ≥ 7 days despite granulocyte colony stimulating factor support, or any febrile (temperature > 38.3°C) neutropenia (ANC < 1000 mm³).~Thrombocytopenia of any grade associated with clinically significant bleeding or platelet/blood transfusion~Grade 4 fatigue lasting ≥ 7 days~Grade 3 nausea, vomiting or diarrhea lasting ≥ 7 days."|First 21-day Cycle|All participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1336572|NCT01987219|Secondary|Change in Forced Expiratory Flow Between 25-75% (FEF25-75)|FEF25-75 is measured in liters of air per second at 25-75%|pre and 30 minutes post intervention||||percentage change from baseline||Standard Deviation|Mean
1336573|NCT01987219|Secondary|Change in Forced Expiratory Volume (FEV) From Baseline|Forced expiratory volume is measured in liters of air per second. FEV was measured during the first second of exhalation.|Pre and 30 post study drug admistration||||percentage change from baseline||Standard Deviation|Mean
1336586|NCT01986946|Secondary|Patient Satisfaction With Overall Care|Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.|||units on a scale||Standard Deviation|Mean
1336587|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.|||units on a scale||Standard Deviation|Mean
1336588|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|Post-operative Day 1|Analyasis was completed on all participants who completed the patient satisfaction with perioperative analgesia assessment.|||units on a scale||Standard Deviation|Mean
1336589|NCT01986946|Primary|Post-operative Pain as Assessed by Visual Analogue Scale (VAS)|The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|Postoperative day 1|Participant that provided a VAS score at postoperative day 1 time point.|||units on a scale||Standard Deviation|Mean
1336590|NCT01986855|Secondary|Percentage of Participants With A1C <7.0% (<53 mmol/Mol) at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Week 26|The analysis population included all randomized participants with a Baseline eGFR ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at Week 26 for the percentage of participants with an A1C <7% at Week 26 endpoint.|||Percentage of participants|||Number
1336591|NCT01986855|Secondary|Change From Baseline in FPG at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 FPG endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1336592|NCT01986855|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 sitting systolic blood pressure minus the Week 0 sitting systolic blood pressure. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 sitting systolic blood pressure endpoint.|||mmHg||95% Confidence Interval|Least Squares Mean
1336593|NCT01986855|Secondary|Change From Baseline in Body Weight at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 body weight endpoint.|||Kilograms||95% Confidence Interval|Least Squares Mean
1336594|NCT01986855|Secondary|Change From Baseline in A1C at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 A1C endpoint.|||Percentage||95% Confidence Interval|Least Squares Mean
1336595|NCT01986855|Primary|Percentage of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 52 weeks|The analysis population included all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
1336596|NCT01986855|Primary|Percentage of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 54 weeks|The analysis population included all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
1336626|NCT01986062|Secondary|PERM-P Scores - Number of Problems Correct|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT|||number of problems correct||Standard Deviation|Mean
1336597|NCT01986855|Primary|Change From Baseline in A1C at Week 26 - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 A1C endpoint.|||Percentage||95% Confidence Interval|Least Squares Mean
1336598|NCT01986790|Primary|Satisfaction|A survey will be administered in order to measure the extent to which participants are satisfied with the information presented to them. Satisfaction was scored on a scale from 1 to 4, with higher scores indicating higher levels of satisfaction. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated satisfaction.|||Units on a scale||Standard Deviation|Mean
1336599|NCT01986790|Primary|Uncertainty|A survey will be administered in order to measure participants' confidence in the features of health insurance plans that matter most to them and the insurance plan they chose of the ones presented. Confidence in choice is scored on a scale from 0 to 100, with higher scores indicating more decisional conflict/more uncertainty/less confidence in choice. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated uncertainty.|||Units on a scale||Standard Deviation|Mean
1336600|NCT01986790|Primary|Knowledge|Knowledge measures the degree at which participants understand the details about health insurance plans. Knowledge was scored on a scale from 0 to 7 based on number of correct answers to the 7 items. A higher value is considered to be a better outcome. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated knowledge.|||Units on a scale||Standard Deviation|Mean
1336601|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group|Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours|Study was prematurely terminated. No data were collected for this assessment||||||
1336602|NCT01986751|Secondary|Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.|Comparing the mean time to the first analgesic intake postoperative between the control group and the study group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment||||||
1336603|NCT01986751|Secondary|the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.|Comparing the mean hours from start of procedure to discharge between the study group and the control group|baseline to discharge (approximately 72 hours)|Study was prematurely terminated. No data were collected for this assessment||||||
1336604|NCT01986751|Secondary|Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo|Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.|baseline to discharge from hospital (expected 3 days)|Study was prematurely terminated. No data were collected for this assessment||||||
1336605|NCT01986751|Secondary|Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group|Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment||||||
1336606|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group|The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment||||||
1336607|NCT01986751|Primary|Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group|Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment||||||
1336608|NCT01986751|Primary|Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group|Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment.||||||
1336609|NCT01986686|Secondary|Recurrence and Treatment|Data will be collected on recurrence and treatment for recurrent diverticulitis|2 years|||||||
1336610|NCT01986686|Secondary|Post Operative Complications|Data will be collected on percent and type of complications for the surgery arm.|30 days|||||||
1336611|NCT01986686|Secondary|Readmission|Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.|30 days|||||||
1336612|NCT01986686|Secondary|Mortality|Data will be collected on percent of patients who die during the follow-up period after enrollment.|4 years|||||||
1336613|NCT01986686|Secondary|Measure Length of Hospital Stay for Surgery vs Non Surgery Patients|Data collected will include length of hospital stay from the date of admission to discharge day for nonoperative management of the first episode of Hinchey II diverticulitis.|4 years|||||||
1336614|NCT01986686|Primary|Primary Study Endpoint|The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.|Minimum of 1 year after enrollment||||Participants|||Count of Participants
1336615|NCT01986361|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3)|"The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours, for a total of 24 post-dose measurements.~The time-weighted SPID combines relief magnitude (PID = change from baseline) as weighted by duration interval between ratings. SPID3 refers to measurements taken up to 3 hours post-baseline, and has a full range of -1332 (complete pain relief within 5 minutes of dosing that lasts for 3 hours) to 468 (drug escalates level of pain to a score of 10 and the pain stays at that level for 3 hours) using the mean baseline STS value 7.4 for this study."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat|||units on a scale||95% Confidence Interval|Mean
1336616|NCT01986361|Secondary|Percentage of Participants With Perceived Pain Relief|Defined as the percentage of participants who pressed the first stopwatch during the 3 hour evaluation period.|up to 3 hours post dose on Day 1|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1336617|NCT01986361|Secondary|Percentage of Participants With Meaningful Pain Relief|Defined as the percentage of participants who pressed the second stopwatch during the 3 hour evaluation period.|up to 3 hours post dose on Day 1|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1336618|NCT01986361|Secondary|Change From Baseline at Individual Timepoints in Sore Throat Scale (STS)|"The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat|||units on a scale||Standard Deviation|Mean
1336619|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS)|"Time to pain reduction on the STS (defined as any reduction or decrease observed during the 3 hours post dose) for participants whose improvement was confirmed by a >=20% reduction in pain on the STPIS.~STS: The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours.~STPIS: The participant was instructed to swallow and: “Place a line on the Sore Throat Scale that best characterizes the severity of your sore throat now:” 0mm=no pain and 100mm=severe pain. The STPIS was obtained at baseline, after the participant depressed the second stopwatch, and at 1, 2, and 3 hours postdose."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
1336620|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS)|"Time to first indication of sore throat relief, defined as any reduction or decrease in STS observed during the 3 hours post dose. Participants who did not have any reduction in STS from baseline within 3 hours were censored to 3 hours.~The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: “Circle the number that shows how sore your throat is now when you swallow.” The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours."|up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
1336621|NCT01986361|Secondary|Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief|Time to first perceived pain relief on the first stopwatch that was confirmed by meaningful pain relief on the second stopwatch. Participants who had no meaningful pain relief within 3 hours from baseline were censored to 3 hours.|up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
1336622|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Perceived Pain Relief|"Time to first perceived pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the first stop watch when they experience any pain relief, termed perceived pain relief. Instructions to participants are: “Stop the first stopwatch when you first feel any sore throat pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief of the throat pain you have now.” Participants who did not have perceived pain relief were censored at 3 hours."|up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
1336623|NCT01986361|Primary|Kaplan-Meier Estimates for Time to Meaningful Pain Relief|Time to meaningful pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the second stop watch when they experience what they perceive as meaningful pain relief. Instructions to participants are: “Stop the second stopwatch when the sore throat pain relief is meaningful to you. This does not mean you feel completely better, although you might, but when you feel relief of throat pain that is meaningful to you.” Participants who did not have perceived pain relief were censored at 3 hours.|up to 3 hours post dose on Day 1|Intent to treat population|||minutes||95% Confidence Interval|Median
1336624|NCT01986231|Secondary|Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fed state.|Baseline and 41 hours||||g/L||Standard Deviation|Mean
1336625|NCT01986231|Primary|Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fasting state.|Baseline and 41 hours||||g/L||Standard Deviation|Mean
1336706|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336627|NCT01986062|Secondary|PERM-P Scores - Number of Problems Attempted|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT|||number of problems attempted||Standard Deviation|Mean
1336628|NCT01986062|Secondary|SKAMP Subscale - Deportment Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose||||units on a scale||Standard Deviation|Mean
1336629|NCT01986062|Secondary|SKAMP Subscale - Attention Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose||||units on a scale||Standard Deviation|Mean
1336630|NCT01986062|Secondary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|0.75, 4, 6, 8, 10 hours post-dose||||units on a scale||Standard Deviation|Mean
1336631|NCT01986062|Primary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|2 hours post-dose|ITT Population|||units on a scale||Standard Deviation|Mean
1336632|NCT01985685|Secondary|Change in Central Venous Oxygen Saturation|Change in central venous oxygen saturation|6 hrs||||percent||Inter-Quartile Range|Median
1336633|NCT01985685|Secondary|Percentage Change in Serum Lactate|Percentage change in serum lactate|6 hrs||||percentage change||Inter-Quartile Range|Median
1336634|NCT01985685|Primary|Change in VO2 Over Time|The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.|6 hrs||||ml/kg/min||Inter-Quartile Range|Median
1336635|NCT01985581|Secondary|Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale|CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Subjects who felt very much improved or much improved are considered improved.The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||percentage of subjects|||Number
1336636|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale|The Clinical Global Impression- Severity scale is a scale of illness ranging from 1 (normal) to 7 (among the most severely ill patients). Subjects who felt normal, not at all ill or borderline mentally ill are considered improved. The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||percentage of subjects|||Number
1336637|NCT01985581|Secondary|Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the parent (KINDL-parent). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the parent.|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
1336638|NCT01985581|Secondary|Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm|To compare the number of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and incident of Serious Adverse Events (SAEs) in each treatment arm|Measured up to 30 weeks|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||subjects|||Number
1336639|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV)|The ADHD-RS-IV is completed by the Investigator familiar with the scale. It is an 18 item scale designed to reflect current symptomatology of ADHD based on the DSM-5 criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, with higher scores reflecting more severe symptoms|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
1336640|NCT01985581|Secondary|Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the subject (KINDL-child). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the child|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
1336641|NCT01985581|Primary|Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires|The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.|measured at baseline and end of each 12 week treament arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline BRIEF questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
1336642|NCT01985425|Secondary|Post-operative Infection||Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
1336643|NCT01985425|Secondary|Transient Ischemic Attack (TIA)|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
1336644|NCT01985425|Secondary|Stroke|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting more than 24 hours and cerebral imaging consistent with acute stroke.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
1336645|NCT01985425|Secondary|Myocardial Injury After Non-Cardiac Surgery (MINS)|"Requires one of the following criteria:~A) Elevated troponin or CK-MB measurement with one or more of the following defining features:~Ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema);~Development of pathologic Q waves present in any two contiguous leads that are >30 milliseconds;~Electrocardiogram (ECG) changes indicative of ischemia (i.e., ST segment elevation [>2 mm in leads V1, V2, or V3 OR >1 mm in the other leads], ST segment depression [>1 mm], OR symmetric inversion of T waves >1 mm) in at least two contiguous leads;~New LBBB; or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging;~B) Elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury"|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
1336646|NCT01985425|Secondary|New Onset Atrial Flutter|Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
1336647|NCT01985425|Secondary|Death||Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
1336648|NCT01985425|Primary|Clinically Significant Atrial Fibrillation|New atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion, or that lasts for longer than 30 seconds.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
1336649|NCT01985321|Secondary|Number of Treatment Related Adverse Events||Days 1-28||||participants|||Number
1336650|NCT01985321|Primary|Clinician Assessed Duration of Complete Healing of the Herpetic Episode||Days 1-14|Modified Intent to Treat Population: 2 subjects in placebo group violated protocol and could not be evaluated for Complete Healing (83-2=81). 5 subjects in active group started treatment prior to contacting site; 1 subject in active group lost to follow-up with no site visits. These 6 active subjects not used in Complete Healing analysis (90-6=84)|||hours||Full Range|Median
1336651|NCT01985126|Secondary|Time to Disease Progression|Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||months||95% Confidence Interval|Median
1336652|NCT01985126|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||months||95% Confidence Interval|Median
1336653|NCT01985126|Secondary|Time to Response|Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better).|Up to 14.4 Months|Responders in all treated analysis set. Only those participants with confirmed PR were analyzed.|||months||Full Range|Median
1336654|NCT01985126|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||percentage of participants||95% Confidence Interval|Number
1336655|NCT01985126|Secondary|Overall Survival|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.|Approximately up to 3 years|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||months||95% Confidence Interval|Median
1336707|NCT01984424|Secondary|Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL||Week 24|Participants randomized and dosed in Part B of the study|||percentage of participants||95% Confidence Interval|Number
1336708|NCT01984424|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL||Weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percentage of participants||95% Confidence Interval|Number
1336656|NCT01985126|Secondary|Duration of Response|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder.|Up to 14.4 Months|Responders in all treated analysis set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
1336657|NCT01985126|Primary|Percentage of Participants With Overall Response|Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; PR: >= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||percentage of participants||95% Confidence Interval|Number
1336658|NCT01984892|Other Pre-specified|Overall Survival in Treated Patients|Patients who are alive on the date of closing follow-up, or 30 months after completing all study treatments, will be censored on that date|up to 30 months||||Participants|||Count of Participants
1336659|NCT01984892|Secondary|Therapeutic Effect in Treated Patients|Induction of innate and/or an adaptive, specific anti-tumor T cell immune response in the injected tumor lesion and also systemically.|24 months|study terminated early, data not collected. study terminated before all study visits completed. this 24 month visit was not done.||||||
1336660|NCT01984892|Primary|Progression-free Survival|"Progression-free survival defined as the time in weeks from study entry until tumor progression defined using the Wolchok criteria or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date.~In order to minimize the potential for misdiagnosis of pseudoprogression, related to early inflammation, tumor measurement for determination of progression will be made at the earliest at 26 weeks."|average 52 weeks||||weeks|||Number
1336661|NCT01984697|Other Pre-specified|Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.|Month 36|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336662|NCT01984697|Other Pre-specified|Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|Month 36|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336663|NCT01984697|Other Pre-specified|Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.|Month 24|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336664|NCT01984697|Other Pre-specified|Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|Month 24|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336709|NCT01984424|Secondary|Change From Baseline in LDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||mg/dL||Standard Error|Least Squares Mean
1336710|NCT01984424|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 22 and 24||Baselie and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||mg/dL||Standard Error|Least Squares Mean
1336711|NCT01984424|Primary|Percent Change From Baseline in LDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in part B of the study|||percent change||Standard Error|Least Squares Mean
1336665|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336666|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336667|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336668|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336669|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336670|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336671|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336672|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336673|NCT01984697|Primary|Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336674|NCT01984697|Primary|Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336675|NCT01984697|Primary|Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336676|NCT01984697|Primary|Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336677|NCT01984697|Primary|Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336678|NCT01984697|Primary|Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336679|NCT01984697|Primary|Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336680|NCT01984697|Primary|Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336681|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
1336682|NCT01984697|Primary|Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
1336683|NCT01984684|Secondary|Investigator-assessed Response of Signs and Symptoms of Infection at the Late Follow-up Visit|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 21 to 28||||Participants|||Count of Participants
1336712|NCT01984424|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in part B of the study|||percent change||Standard Error|Least Squares Mean
1336713|NCT01984294|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1336684|NCT01984684|Secondary|Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [EMA] Primary Endpoint)|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 14 ± 1|ITT Population|||Participants|||Count of Participants
1336685|NCT01984684|Primary|Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge.|A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.|48 to 72 hrs after starting treatment|ITT Population|||Participants|||Count of Participants
1336686|NCT01984515|Secondary|Patient Health Questionnaire-9 Item|9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.|Referral Management Initiation, 1 month post initiation, 3 months post initiation||||units on a scale||Standard Deviation|Mean
1336687|NCT01984515|Secondary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.|Referral Management Initiation, 1 month post initiation, 3 months post initiation||||units on a scale||Standard Deviation|Mean
1336688|NCT01984515|Primary|Engagement in Evidence-based Psychotherapy for PTSD|Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.|From initiation of the Referral Management System to 6 months after initiation||||participants|||Number
1336689|NCT01984424|Secondary|Percent Change From Baseline in VLDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336690|NCT01984424|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336691|NCT01984424|Secondary|Percent Change From Baseline in HDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336692|NCT01984424|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336693|NCT01984424|Secondary|Percent Change From Baseline in Triglycerides at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336694|NCT01984424|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336695|NCT01984424|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336696|NCT01984424|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 22 and 24||Baseline and Weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336697|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336698|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 22 and 24||Baseline and Weeks 22 and 24|Participants randomized and dosed in Part B of the study.|||percent change||Standard Error|Least Squares Mean
1336699|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336700|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336701|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336702|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336703|NCT01984424|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336704|NCT01984424|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336705|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
1336714|NCT01984294|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 8 weeks|Full Analysis Set|||percentage of participants|||Number
1336715|NCT01984294|Secondary|Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set|||percentage of participants|||Number
1336716|NCT01984294|Primary|Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants were randomized and received at least one dose of study drug.|||percentage of participants|||Number
1336717|NCT01984294|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study drug.|||percentage of participants|||Number
1336718|NCT01984242|Other Pre-specified|EuroQoL 5 Dimension (EQ-5D) Questionnaire Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)|As this outcome was pre-specified as an exploratory outcome, no results are reported.||||||
1336719|NCT01984242|Secondary|Brief Fatigue Inventory (BFI) Fatigue Level Score|BFI questionnaire comprises of 2 parts: fatigue level (3 items), interference with daily life (1 item with 6 sub-items). Each items in the fatigue level score was answered on a scale of 0 (no fatigue) to 10 (as bad as you can imagine). The mean score of all 3 items was reported on the scale of 0 (no fatigue) to 10 (as bad as you can imagine).|Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)|PRO-evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure. ‘Number Analyzed’=participants evaluable for this outcome measure at specified timepoint for each arm respectively.|||units on a scale||Standard Deviation|Mean
1336720|NCT01984242|Secondary|M.D. Anderson Symptom Inventory (MDASI) Interference Score|MDASI questionnaire comprises of 2 parts: symptoms (16 items), interference with daily life (6 items). Participants were asked to rate how much their symptoms interfered with general activity, mood, work, relations with other people, walking, and enjoyment of life during the last 24 hours. Each item in the interference score was answered on a scale of 0 (did not interfere) to 10 (interfered completely). The mean score of all 6 items was reported on the scale of 0 (did not interfere) to 10 (interfered completely).|Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)|Patient Reported Outcome (PRO)-evaluable population: randomized participants who had non-missing baseline assessment and at least 1 post-baseline assessment. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome. ‘Number Analyzed’=participants evaluable for this outcome at specified timepoint for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1336721|NCT01984242|Secondary|Cmin of Bevacizumab||For Atezolizumab and Bevacizumab Arm: at First-line treatment discontinuation (up to approximately 2.75 years); For Crossover Arms: pre-infusion (0 hour) on Day 1 of Cycle 2 (1 cycle=6 weeks) (infusion length=30-90 minutes)|PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1336722|NCT01984242|Secondary|Cmax of Bevacizumab||30 minutes after end of infusion on Day 1 of Cycles 1 and 2 (1 cycle=6 weeks) (infusion length=30-90 minutes)|PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1336723|NCT01984242|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-infusion (0 hour) on Day 1 of Cycles 2 and 4; Day 22 of Cycles 1, 2, and 4 (1 cycle=6 weeks) (infusion length=30-60 minutes)|PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure. ‘Number Analyzed’=participants evaluable for this outcome measure at specified timepoint for each arm respectively.|||mcg/mL||Standard Deviation|Mean
1336724|NCT01984242|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||30 minutes after end of infusion on Cycle 1 Day 1 (1 cycle=6 weeks) (infusion length for first dose=60 minutes)|The pharmacokinetic (PK) evaluable population included participants who received at least one dose of study drug and had sufficient PK sample collected within the time specified in the protocol. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1336725|NCT01984242|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab|This outcome measure was planned to be analyzed in ‘Atezolizumab’ and ‘Atezolizumab and Bevacizumab’ arms only.|Cycle 1 Day 1 until treatment discontinuation (until data cut-off date 17 October 2016, up to approximately 2.75 years) (1 cycle=6 weeks)|ATA evaluable population included participants at baseline who had a baseline ATA sample and post-baseline participants who had at least one ATA sample and had received at least one dose of study treatment.|||percentage of participants|||Number
1336726|NCT01984242|Secondary|PFS Per RECIST v.1.1 Via Investigator Assessment in Crossover Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population|||months||95% Confidence Interval|Median
1336727|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Crossover Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population|||percentage of participants|||Number
1336728|NCT01984242|Secondary|DOR Per RECIST v1.1 Via Investigator Assessment in Crossover Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1336729|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in Crossover Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population included participants in atezolizumab or sunitinib arms who had crossed over to the atezolizumab and bevacizumab arm. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1336730|NCT01984242|Secondary|OS in IC1/2/3 Population|OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier methodology was used to estimate OS.|Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
1336731|NCT01984242|Secondary|Percentage of Participants Who Died in IC1/2/3 Population||Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants|||Number
1336732|NCT01984242|Secondary|Overall Survival (OS) in ITT Population|OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier methodology was used to estimate OS.|Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
1336733|NCT01984242|Secondary|Percentage of Participants Who Died in ITT Population||Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
1336734|NCT01984242|Secondary|DOR Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1336735|NCT01984242|Secondary|DOR Per Modified RECIST Via Investigator Assessment in ITT Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1336744|NCT01984242|Secondary|Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants||95% Confidence Interval|Number
1336811|NCT01983566|Primary|Cmax|Maximum measured concentration of deleobuvir in plasma (Cmax)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1336736|NCT01984242|Secondary|DOR Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1336737|NCT01984242|Secondary|DOR Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1336738|NCT01984242|Secondary|DOR Per RECIST v1.1 Via Investigator Assessment in ITT Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1336739|NCT01984242|Secondary|Duration of Response (DOR) Per RECIST v1.1 Via IRC Assessment in ITT Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1336740|NCT01984242|Secondary|PFS Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
1336741|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in IC1/2/3 Population|PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants|||Number
1336742|NCT01984242|Secondary|PFS Per Modified RECIST Via Investigator Assessment in ITT Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
1336743|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in ITT Population|PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
1336745|NCT01984242|Secondary|Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in ITT Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
1336746|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants||95% Confidence Interval|Number
1336747|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in ITT Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
1336748|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants||95% Confidence Interval|Number
1336749|NCT01984242|Secondary|Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) Per RECIST v1.1 Via IRC Assessment in ITT Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to less than (<) 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
1336750|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
1336751|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in IC1/2/3 Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants|||Number
1336752|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in ITT Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
1336753|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in ITT Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
1336776|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
1336754|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
1336755|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
1336756|NCT01984242|Secondary|PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
1336757|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
1336758|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
1336759|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
1336760|NCT01984242|Secondary|PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
1336761|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population included ITT participants whose tumor samples had sufficient material available for gene signature expression analyses. Participants with higher than median expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
1336839|NCT01982435|Secondary|Number of Participants With Nonperfusion|Number of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia).|3, 6 and 12 months||||Participants|||Count of Participants
1336762|NCT01984242|Primary|PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
1336763|NCT01984242|Primary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population included ITT participants with programmed death-ligand 1 (PD-L1) expression of greater than or equal to (>=) 1% on tumor-infiltrating immune cells.|||percentage of participants|||Number
1336764|NCT01984242|Primary|Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
1336765|NCT01984242|Primary|Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population|Progressive Disease (PD): at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm); appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
1336766|NCT01984229|Secondary|t1/2 of RO5468924: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||hours||Standard Deviation|Mean
1336767|NCT01984229|Secondary|t1/2 of RO5468924: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Standard Deviation|Mean
1336768|NCT01984229|Secondary|t1/2 of Alectinib: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||hours||Standard Deviation|Mean
1336769|NCT01984229|Secondary|Terminal Half-life (t1/2) of Alectinib: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]|||hours||Standard Deviation|Mean
1336770|NCT01984229|Secondary|Metabolite/Parent Ratio for Cmax: Cohort B|RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||ratio||Standard Deviation|Geometric Mean
1336771|NCT01984229|Secondary|Metabolite/Parent Ratio for AUC0-inf: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||ratio||Standard Deviation|Geometric Mean
1336772|NCT01984229|Secondary|Tmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||hours||Full Range|Median
1336773|NCT01984229|Secondary|Tmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]|||hours||Full Range|Median
1336774|NCT01984229|Secondary|Tmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort B]|||hours||Full Range|Median
1336775|NCT01984229|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]|||hours||Full Range|Median
1336840|NCT01982435|Secondary|Number of Participants With Angiographic Leakage|Number of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage).|3, 6 and 12 months||||Participants|||Count of Participants
1336777|NCT01984229|Secondary|AUClast of RO5468924: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
1336778|NCT01984229|Secondary|Cmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||ng/mL||Standard Deviation|Mean
1336779|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort A|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
1336780|NCT01984229|Secondary|AUClast of RO5468924: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]|||h*ng/mL||Standard Deviation|Mean
1336781|NCT01984229|Secondary|Cmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]|||ng/mL||Standard Deviation|Mean
1336782|NCT01984229|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of RO5424802: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
1336783|NCT01984229|Primary|AUClast of Alectinib: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
1336784|NCT01984229|Primary|Cmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||ng/mL||Standard Deviation|Mean
1336785|NCT01984229|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]|||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
1336786|NCT01984229|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|Pharmacokinetic (PK) Analysis Population [Cohort A] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1336787|NCT01983878|Secondary|PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: Enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||hours x micrograms/milliliters (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1336788|NCT01983878|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||micrograms/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1336789|NCT01983878|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up|All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data.|||participants|||Number
1336790|NCT01983878|Secondary|Overall Survival (OS)|The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.|Baseline to Death from Any Cause (Up to 13 Months)|FAS: all enrolled participants who received at least one dose of the study drug. 18 participants were censored.|||Months||90% Confidence Interval|Median
1336801|NCT01983683|Other Pre-specified|Sustained Cure Rate (SCR) in the Per-protocol Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|Per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
1343038|NCT01904760|Other Pre-specified|Pain Score in PACU|Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU.|at 8 am the next day|||||||
1336791|NCT01983878|Secondary|Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control = (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 12 Months)|FAS: all enrolled participants who received at least one dose of the study drug.|||Percentage of Participants||90% Confidence Interval|Number
1336792|NCT01983878|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of CR or PR. According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response = (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks)|FAS: all enrolled participants who received at least one dose of the study drug.|||Percentage of Participants||90% Confidence Interval|Number
1336793|NCT01983878|Secondary|Progression-Free Survival (PFS)|The time from baseline to measured Progressive Disease (PD) as defined by RECIST v.1.1 [defined as > 20% increase from smallest sum of longest diameter recorded since treatment started (best response)], or death due to any cause, whichever is first.|Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks)|FAS: all enrolled participants who received at least one dose of the study drug. 8 participants were censored.|||Weeks||90% Confidence Interval|Median
1336794|NCT01983878|Primary|Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)|The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.|12 Weeks|Full Analysis Set (FAS): all enrolled participants who received at least one dose of the study drug. 8 participants were censored.|||Percentage of Participants||90% Confidence Interval|Number
1336795|NCT01983839|Primary|Area Under the Free Concentration-time Curve (fAUC0-24)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of fAUC0-24 for the current study population were reported.~fAUC0-24 were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment|The model estimated median values of fAUC0-24 for the current study population were32.78 mg.hr/L (IQR 22.75; 47.31). respectively.|||mg.hr/L||Inter-Quartile Range|Median
1336796|NCT01983839|Primary|Total Peak Plasma Concentration (Cmax)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of total Cmax for the current study population were reported.~Each individual model predicted Cmax were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment||||mg/L||Inter-Quartile Range|Median
1336797|NCT01983787|Secondary|MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.|MIC to piperacillin/tazobactam was obtained by using E-tests (AB Biodisk, Solna, Sweden) on Mueller-Hinton agar plates incubated at 35 ± 2 degrees Celcius with inoculum, incubation time and atmosphere in accordance to the E-test application guide.|Sputum sample was collected 3 to 7 days before treatment initiation.||||mg/L|||Number
1336798|NCT01983787|Secondary|The Time Above the Minimum Inhibitory Concentration (T>MIC)|"The time, expressed in percentage, for which the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%. MIC for the pathogen in sputum was not reported in patient 5. Therefore,T>MIC for this patient could not be estimated.~Patient 1-5 were treated with piperacillin 16g/day. Patient 6-10 were treated with piperacillin 12g/day."|Patients will be followed for the duration of treatment, which is approximately 2 weeks.||||% of time above the MIC|||Number
1336799|NCT01983787|Primary|Blood-plasma Concentration of Piperacillin|"The free, non-protein bound fraction of plasma piperacillin for each patient was determined using Ultra High Performance Liquid Chromatography. The concentration was compared to the MIC-value (Minimal Inhibitory Concentration) of the pathogen isolated in a sputum sample collected prior to initiation of antibiotic treatment.~Infusion pumps with 16 g of piperacillin per 24 hours were initially used and five patients had piperacillin plasma-concentrations monitored during this treatment regimen. However, in three of these patients, the piperacillin plasma concentrations were unexpectedly low and dropped to a level below the MIC. This was found to be due to antibiotic crystallization within the infusion pumps as a result of the antibiotic concentration being too high. Consequently, infusion pumps with 12 g of piperacillin per 24 hours were used in stead. The median piperaillin concentrations reported below are derived from all measurements within the two weeks of treatment."|Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment||||mg/L||Inter-Quartile Range|Median
1336800|NCT01983683|Other Pre-specified|Recurrence Rate|Recurrence is defined as the occurrence of a new episode of diarrhea (> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.|Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)|Subjects from the modified intent-to-treat analysis set (mITT) with clinical cure|||Percentage of participants||95% Confidence Interval|Number
1336802|NCT01983683|Other Pre-specified|Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5|ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having ‘Not Sustained Cure’ for the analysis. ISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT).|Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of participants||95% Confidence Interval|Number
1336803|NCT01983683|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|Per-protocol population: all subjects from the mITT analysis set without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
1336804|NCT01983683|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|Modified intent-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of participants||95% Confidence Interval|Number
1336805|NCT01983683|Secondary|Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores|CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms.|Baseline to End of Treatment (10 days after starting study drug) + 2 days|All subjects from the modified intent-to-treat population, excluding those who participated in the validation sub-study. No imputation of missing scores is performed prior to deriving response status. Subjects with missing values at baseline or at Day 3 are considered to be non-responders.|||Scores on a scale||95% Confidence Interval|Number
1336806|NCT01983683|Secondary|Kaplan-Meier Estimates for Resolution of Diarrhea (ROD)|"Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment.~The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point."|Up to Day 10|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||KM estimate (% subjects with ROD)||95% Confidence Interval|Number
1336807|NCT01983683|Secondary|Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of subjects||95% Confidence Interval|Number
1336808|NCT01983683|Primary|Clinical Cure Rate (CCR) in the Per-protocol Population|Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (end-of-treatment + 2 days)|per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
1336809|NCT01983683|Primary|Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population|Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive). CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.|Up to Day 12 on average (end-of-treatment + 2 days)|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of participants||95% Confidence Interval|Number
1336810|NCT01983566|Secondary|AUC(0-inf)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS - Due to premature discontinuation of the study, this endpoint was not evaluated.||||||
1336812|NCT01983566|Primary|AUC(0-tz)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|Pharmacokinetic set (PKS): included all subjects in the Treated Set who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint that was not affected by important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1336813|NCT01983254|Other Pre-specified|Total Weeks at Home Post-randomization|here reported as weeks (instead of days) not at home for simplicity|over 6 months follow up|patients|||weeks not at home during follow up|weeks|Standard Deviation|Mean
1336814|NCT01983254|Secondary|Impact of Events Scale-revised (IES-R) Score|The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately often,” 3 = “quite a bit,” and 4 = “extremely often.” The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well.|3 & 6 months post-randomization|Patients who completed the IES-R scale at 3 & 6 months post-randomization.|||units on a scale (IES-R)||Standard Error|Mean
1336815|NCT01983254|Primary|Hospital Anxiety and Depression Scale Score|Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well|3 & 6 months post-randomization|Patients who completed the HADS scale at 3 & 6 months post-randomization.|||units on a scale (HADS summary score)||Standard Error|Mean
1336816|NCT01983111|Secondary|Patient Global Impressions of Change(PGIC)|"In the PP set, Number of participants with categorical change in overall satisfaction.~PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse)."|6 weeks|Per protocol set: Analyze the within-group change in the PGIC from Baseline (Week 0) to Week 6 by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.|||Scores on 1 to 7point||Standard Deviation|Mean
1336817|NCT01983111|Secondary|Clinical Global Impression of Change(CGIC)|The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse.|6 weeks|In the per protocol: Analyze the within-group change in the CGIC from Baseline (Week 0) to Week 6 of the investigational product administration by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.|||Scores on 1 to 7 point||Standard Deviation|Mean
1336818|NCT01983111|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline and at 6weeks|In the PP set, the change in the your today health score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.|||scores on a scale||Standard Deviation|Mean
1336819|NCT01983111|Secondary|Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for ‘Motor capability’, ‘Self-care’, ‘Daily activities’, ‘Pain/discomfort’, ‘Depression/anxiety’ and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by “1” means that the healthy condition and high quality of life."|Baseline and at 6 weeks|In the PP set, the change in the quality of life (EQ-5D) total score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.|||EQ-5D Total score||Standard Deviation|Mean
1336820|NCT01983111|Secondary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline.|2 weeks|In the PP set, the reduction in the pain intensity score from Visit 1 (Baseline) to Week 2 of the investigational product administration was analyzed.|||Scores on a scale||Standard Deviation|Mean
1336821|NCT01983111|Primary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline.|baseline and 6 weeks|In the PP set, the change in the pain intensity score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.|||Scores on a scale||Standard Deviation|Mean
1336822|NCT01983020|Primary|Pain Intensity|The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).|postoperative day 1 - 3||||units on a scale||Standard Deviation|Mean
1336823|NCT01982812|Secondary|Sequelae|"Neurologic outcome in 3 categories--~Neurologically intact at discharge~Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge~Died during admission, never discharged"|7 days||||participants|||Number
1336824|NCT01982812|Secondary|Mean Time From Admission to BCS >/= 4|"The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis.~The Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement~1 - Watches or follows 0 - Fails to watch or follow~Best motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response~Best verbal response 2 - Cries appropriately with pain, or, if verbal, speaks~1 - Moan or abnormal cry with pain 0 - No vocal response to pain"|7 days|Comparing mean time to coma resolution in hours among survivors|||hours of coma from admission||Standard Deviation|Mean
1336825|NCT01982812|Secondary|Required Additional AED|Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no)|7 days||||Participants requiring additional AEDs|||Number
1336826|NCT01982812|Primary|Minutes With Seizure on EEG|Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.|72 hours||||minutes with seizure||Standard Deviation|Mean
1336827|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.|12 week follow up||||units on a scale||Standard Deviation|Mean
1336828|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.|6 week follow up||||units on a scale||Standard Deviation|Mean
1336829|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.|3 week follow up||||units on a scale||Standard Deviation|Mean
1336830|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48. The higher the score indicated the greater risk for suicidal ideation.|Baseline||||units on a scale||Standard Deviation|Mean
1336831|NCT01982695|Primary|Cardiac Ejection Fraction as Measured by Echocardiogram|Mean cardiac ejection fraction as measured by echocardiogram at 12 month study visit. Cardiac ejection fractions were measured using the biplane Simpson’s rule using images obtained from the apical 4 chamber views of the heart.|12 month visit|All patients that received a 12 month echocardiogram evaluation|||percentage of blood leaving the heart||Standard Deviation|Mean
1336832|NCT01982682|Secondary|Median Pace of T Cell Immune Recovery at 90 Days Post Hematopoietic Stem Cell Transplantation (HSCT)|An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 90 days will be monitored by collecting cluster of differentiation (CD24) and (CD38).|90 days post HSCT|5 subjects were not evaluable for this outcome measure.|||cells/ul||Full Range|Median
1336833|NCT01982682|Secondary|Median Pace of T Cell Immune Recovery at 28 Days Post Hematopoietic Stem Cell Transplantation (HSCT)|An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 28 days will be monitored by collecting cluster of differentiation (CD24) and (CD38).|At 28 days post HSCT|3 subjects were not evaluable for this outcome measure.|||cells/ul||Full Range|Median
1336834|NCT01982682|Secondary|Count of Participants That Experienced Death as a Result of Graft-versus-host Disease (GVHD)|"Graft versus host disease was clinically characterized based on 4 stages of progression for three major body areas, skin, liver, gut. Subjects who experienced life threatening reactions in their skin, liver and gut ultimately experienced functional impairment and expired.~Life threatening reactions in the Skin were characterized by desquamation (the shedding of the outer layers of skin) and bullae (a bubblelike cavity filled with air or fluid, in particular).~Life threatening reactions in the Liver were characterized by Bilirubin, > 15 mg/dl Life threatening reactions in the Gut were characterized by Pain +/- ileus (a painful obstruction of the ileum or other part of the intestine.)"|Up to 1 year after HSCT||||Participants|||Count of Participants
1336835|NCT01982682|Secondary|Number of Participants With Successful Engraftment|Will be reported descriptively. Successful engraftment is defined as ANC (absolute neutrophil count, the number of white blood cells (WBCs) that are neutrophils) ≥ 0.5x109/L for at least 30 days and Platelet engraftment > 20,000 with no transfusion x 7 days.|Up to 1 year after HSCT|One subject was inevaluable|||Participants|||Count of Participants
1336836|NCT01982682|Primary|Count of Participants That Experience 1 Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplantation (HSCT) Using the Thomas Jefferson University 2 Step Approach||Up to 1 year after HSCT|One subject was inevaluable.|||Participants|||Count of Participants
1336837|NCT01982539|Secondary|Efficacy|To determine efficacy by assessing percent changes of the Numeric Pain Rating Scale (NPRS) pain score from baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.|From Baseline to 1st and 2nd hour|||||||
1336838|NCT01982539|Primary|To Confirm the Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years|"Safety Endpoints:~Treatment emergent AEs (TEAEs)~Serious adverse events (SAEs)~Withdrawals due to AEs~Deaths~Observed values and changes in vital sign measurements~Observed values and changes in clinical laboratory results~Physical examination findings"|First dose to 30 days after the last dose|The Safety population included all subjects who received at least 1 dose of the study drug.|||participants|||Number
1336845|NCT01982435|Secondary|Mean Change in Central Foveal Thickness|Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield)|Months 6 and 12||||microns||Standard Deviation|Mean
1336846|NCT01982435|Secondary|Mean Change in BCVA|Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12.|Months 6 and 12||||ETDRS letters||Standard Deviation|Mean
1336847|NCT01982435|Primary|Number of Participants With Severe Non-ocular Adverse Event|As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months||||Participants|||Count of Participants
1336848|NCT01982435|Primary|Number of Participants With Non-severe Non-ocular Adverse Event|As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months||||Participants|||Count of Participants
1336849|NCT01982435|Primary|Number of Participants With Severe Ocular Adverse Events|As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs.|12 months||||Participants|||Count of Participants
1336850|NCT01982435|Primary|Number of Participants With Non-severe Ocular Adverse Events|As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months|Patients who exited the study early were accounted by using a last observation carried forward approach.|||Participants|||Count of Participants
1336851|NCT01982383|Primary|Resolution of Fluid Build-up|Central Serous Choroidopathy is a disease that causes fluid to build up under the retina,the back part of the inner eye that sends sight information to the brain. The objective here is to apply 577nm of micropulse laser to see if CSC resolution occurs and measuring it through ocular coherence tomography (retinal imaging), vision score, and visual field testing for retinal sensitivity.|within 1 week to 3 months after the laser procedure is completed|No data analyzed. Study terminated due to lack of enrollment||||||
1336852|NCT01982292|Secondary|Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)|Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion.|48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||mL/hr/kg||Standard Deviation|Mean
1336853|NCT01982292|Secondary|Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours|This analysis was not done due to sparse PK sampling.|48 hours post each infusion|Due to sparse PK sampling, this analysis was not done.||||||
1336854|NCT01982292|Secondary|Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)|Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available|pre-infusion and 24, 48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/ml||Standard Deviation|Mean
1336855|NCT01982292|Secondary|Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)|Due to sparse PK sampling, AUC 0-48 hours was not analyzed.|pre-infusion and 8, 24 and 48 hours post each infusion.|Due to sparse PK sampling, this analysis was not done.||||||
1336856|NCT01982292|Secondary|Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions|Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain.|16 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.|||Participants|||Number
1336857|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12)|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.~n = the total number of subjects with evaluable antibody status after specified number of infusions"|At Week 4, Week 8, Week 12|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment|||Percentage of participants||90% Confidence Interval|Number
1336858|NCT01982292|Secondary|Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12||Week 4, Week 8, Week 12|Safety set:All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment|||In international Units||Standard Deviation|Mean
1336859|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16|A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period.|Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.|||Percentage of patients||90% Confidence Interval|Number
1338876|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 0 (pre-dose)|Patients who have trough concentration data at Day 0 (pre-dose)|||μg/mL||Standard Deviation|Mean
1336860|NCT01982292|Primary|Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.~A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient’s antibody status is considered to be undetermined during the study if it is not defined as positive or negative."|16 weeks|Safety Set: All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment. In this reported analysis, patients with undetermined antibody status are excluded from analysis population|||Percentage of participants||90% Confidence Interval|Number
1336861|NCT01982253|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|The change between the FPG value collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
1336862|NCT01982253|Primary|Change From Baseline in HbA1c at Week 12.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
1336863|NCT01981967|Secondary|Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®|Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.|Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set|||Participants|||Number
1336864|NCT01981967|Primary|Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®||Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set|||Participants|||Number
1336865|NCT01981967|Primary|Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®||30 minutes post-vaccination up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set|||Participants|||Number
1336866|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Family Cohesion Impact Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336867|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Parent-Time Impact Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336868|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Parent-Emotional Impact Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336869|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Change in Health Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336870|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – General Health Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336955|NCT01980992|Secondary|Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT|The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.|44 Weeks||||Participants|||Count of Participants
1336871|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Behaviour Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336872|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Temperament and Moods Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336873|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Pain Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336874|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Growth and Development Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336875|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 – Physical Abilities Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336876|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child’s parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with available data at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
1336877|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 52 visit|FAS population.|||percentage of days with incontinence|Days||Number
1336878|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 36 visit|FAS population.|||percentage of days with incontinence|Days||Number
1336879|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 24 visit|FAS population.|||percentage of days with incontinence|Days||Number
1336880|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 12 visit|FAS population|||percentage of days with incontinence|Days||Number
1337234|NCT01976806|Primary|Change in Pocket Depth (mm)|Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).|Baseline and 3 months||||mm||Standard Error|Mean
1336881|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 9 visit|FAS population.|||percentage of days with incontinence|Days||Number
1336882|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 6 visit|FAS population.|||percentage of days with incontinence|Days||Number
1336883|NCT01981954|Secondary|Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 3 visit|FAS population.|||percentage of days with incontinence|Days||Number
1336884|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Baseline visit|FAS population.|||percentage of days with incontinence|Days||Number
1336885|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all subjects. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 52 visit|FAS population.|||percentage of days with catheterization|Days||Number
1336886|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 36 visit|FAS population.|||percentage of days with catheterization|Days||Number
1336887|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 24 visit|FAS population.|||percentage of days with catheterization|Days||Number
1336888|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 12 visit|FAS population.|||percentage of days with catheterization|Days||Number
1336889|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 9 visit|FAS population.|||percentage of days with catheterization|Days||Number
1336890|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 6 visit|FAS population.|||percentage of days with catheterization|Days||Number
1336891|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 3 visit|FAS population.|||percentage of days with catheterization|Days||Number
1336892|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Baseline visit|FAS population.|||percentage of days with catheterization|Days||Number
1336956|NCT01980992|Secondary|Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge|The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.|8 to 10 weeks after passing the 2 Year OFC|This is not applicable for the Placebo Crossover subjects as they did not complete at 2 Year Tolerance OFC per the protocol.|||Participants|||Count of Participants
1336893|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours|Participants were required to have 4-6 CICs per day on a schedule fixed for the duration of the study. To calculate the number of periods between CICs with incontinence in a diary day, the diary day was divided into periods between CICs (i.e. inter-CIC periods). The hour period, rather than the exact time, of each CIC and incontinence episode was recorded in the diary. When an incontinence episode and a CIC were marked in the same hour period, the incontinence episode was counted as occurring prior to the CIC (when the bladder had not yet emptied), rather than after it (when the bladder had recently been emptied), i.e. the inter-CIC period ended with the hour in which the CIC was recorded. The mean number of periods between CICs with incontinence per 24 hours was the number of periods between CICs when incontinence occurred, divided by the total number of valid diary days.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||periods||Standard Deviation|Mean
1336894|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume|The first morning catheterized volume was the volume associated with the first morning catheterization. The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||mL||Standard Deviation|Mean
1336895|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)|The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||mL||Standard Deviation|Mean
1336896|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization|The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days were concurrent. Catheterized volumes were recorded for 2 days in a participant diary prior to each visit. Four to six catheterizations were performed every day.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||mL||Standard Deviation|Mean
1336897|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling||Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point.|||contractions||Standard Deviation|Mean
1336898|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and whose pressure reached 30 cmH2O.|||mL||Standard Deviation|Mean
1336899|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and whose pressure reached 20 cmH2O.|||mL||Standard Deviation|Mean
1336900|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and whose pressure reached 10 cmH2O.|||mL||Standard Deviation|Mean
1336901|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O)|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and excluding participants who did not have a detrusor contraction.|||mL||Standard Deviation|Mean
1336902|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling|Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with available data at baseline and at each time point.|||mL||Standard Deviation|Mean
1336903|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling|Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with with available data at baseline and at each time point.|||cmH2O||Standard Deviation|Mean
1336904|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling|Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with available data at baseline and at each time point.|||cmH2O||Standard Deviation|Mean
1336905|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance|Bladder compliance gives an indication of the elasticity of the bladder wall. Bladder compliance was calculated by dividing the change in volume during the filling of the bladder by the change in detrusor pressure during that change in bladder volume using urodynamic assessments. The values for bladder volume and detrusor pressure at the beginning and end of filling were taken and used.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with available data at baseline and at each time point.|||mL/cmH2O||Standard Deviation|Mean
1336906|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC|MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first) as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of EBC was reached for participants ≥ 2 years or of MCV for participants aged 6 months to < 2 years. The participants' bladder was emptied via catheterization).|Baseline and Weeks 3, 6, 9, 12, 52|FAS population with available data at baseline and at each time point.|||mL||Standard Deviation|Mean
1343114|NCT01903863|Secondary|Platelets Transfusion Requirement|Compared platelet transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)||||ml/kilogram/ECMO day||Inter-Quartile Range|Median
1336907|NCT01981954|Primary|Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)|MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity [EBC] was reached for participants ≥ 2 years or of maximum catheterized volume [MCV] for participants aged 6 months to < 2 years; the participants' bladder was emptied via catheterization).|Baseline and Week 24|Full Analysis Set (FAS), which consisted of all participants who took at least one dose of study drug and provided both valid baseline and at least one post-baseline value for the primary efficacy endpoint.|||mL||Standard Deviation|Mean
1336908|NCT01981863|Other Pre-specified|Length of Time Between Incision and Cardiopulmonary Bypass|Mean Length of Time from Incision to Cardiopulmonary Bypass|From incision to bypass, up to 3 hours||||Minutes||Standard Deviation|Mean
1336909|NCT01981863|Secondary|Value of Thromboelastography as Monitor of Fibrinolysis|Thromboelastography may display if fibrinolysis is present|6 months||||percentage of clot||Full Range|Median
1336910|NCT01981863|Primary|Di-Dimer Increase Before Cardiopulmonary Bypass|Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.|6 months|D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients|||ng/mL||Full Range|Median
1336911|NCT01981759|Secondary|Change in Alternate Beliefs Exercise (ABE)|The change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks.|Week 3, Week 4|||||||
1336912|NCT01981759|Secondary|Change in Logical Memory Test-WMS-III|The change in the WMS-III from screening visit 2 to baseline, as a predictor of later change in PSYRATS-D scores from baseline to week 12.|Screening Visit 2, Baseline|||||||
1336913|NCT01981759|Primary|Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D)|The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.|Baseline to Week 12|For week 12 values, only those who completed the week 12 assessments are included in the analysis.|||units on a scale||Standard Deviation|Mean
1336914|NCT01981616|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment.~Serious adverse event (SAE) meant any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. Relationship of each AE to study drug was determined by the Investigator."|From the first dose of study medication through Day 127|The Safety Population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on what they actually received.|||participants|||Number
1336915|NCT01981616|Secondary|Anti-Hepatitis B Surface Antibody Over Time||Baseline and Days 18, 32, 60 and 74|"Per Protocol Population; n indicates the number of participants with available data at each time point."|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1336916|NCT01981616|Secondary|Percentage of Participants With an Immune Response to Oral Cholera Vaccine|A positive immune response was defined as an increase of greater than 4-fold over the Baseline immunoglobulin M (IgM), IgG, or IgA anticholera antibodies.|Baseline and Day 74|The Dukoral Population was defined as all participants who had evaluable samples for assessing immune response to cholera vaccine (Dukoral) vaccine at any visit.|||percentage of participants||95% Confidence Interval|Number
1336917|NCT01981616|Primary|Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74|Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.|Day 74|The Per Protocol Population consisted of all participants who received any amount of study drug and who met predefined evaluability criteria, including receiving the correct and complete dose of study drug, completed both Baseline and day 72 serology assessments and full schedule of hepatitis B vaccine and immunomodulator or corticosteroid use.|||percentage of participants||95% Confidence Interval|Number
1336918|NCT01981564|Secondary|Emergency Department (ED) Visits for Asthma|Number of emergency department visits for asthma in the past 3 months|3 months|No data for one participant in the control group for this outcome|||visits||Standard Deviation|Mean
1336919|NCT01981564|Primary|Symptom Days|Symptom days for asthma during past 14 days|3 months||||symptom days over past 14 days||Standard Deviation|Mean
1336920|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Trough Drug Concentration.|Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.|||Correlation coefficient|||Number
1336921|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Efficacy Measures.|Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.|||Correlation coefficient|||Number
1336922|NCT01981473|Secondary|Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||percentage of participants|||Number
1337309|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
1336923|NCT01981473|Secondary|Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing “no difficulty,” 1 as “some difficulty,” 2 as “much difficulty,” and 3 as “unable to do.” Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst).|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Units on a scale||Standard Deviation|Mean
1336924|NCT01981473|Secondary|Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Units on a scale||Standard Deviation|Mean
1336925|NCT01981473|Secondary|Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject’s General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Units on a scale||Standard Deviation|Mean
1336926|NCT01981473|Secondary|The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||units on a scale||Standard Deviation|Mean
1336927|NCT01981473|Secondary|The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician’s Global Assessment (0-10) + Subject’s Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||units on a scale||Standard Deviation|Mean
1336928|NCT01981473|Secondary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.|Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Percentage of participants|||Number
1336929|NCT01981473|Secondary|Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||µg/mL||Standard Deviation|Mean
1336981|NCT01980589|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:~Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal."|From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.|Safety population|||participants|||Number
1336930|NCT01981473|Secondary|Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).|Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined).|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||percentage of participants|||Number
1336931|NCT01981473|Primary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).|Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Percentage of participants|||Number
1336932|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported therapeutic alliance, measured by the well-validated Working Alliance Inventory (WAI; Horvath & Greenberg, 1989; range 1 to 7, higher score indicated better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||units on a scale||Standard Deviation|Mean
1336933|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported treatment satisfaction, as assessed by the well-validated Client Satisfaction Questionnaire - 8 (CSQ-8; Attkisson & Zwick, 1982; range 0 to 5, higher scores indicate better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||units on a scale||Standard Deviation|Mean
1336934|NCT01981356|Secondary|Experimental Treatment Safety|Assessed by the occurrence of zero adverse events attributable to ACT.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.|||adverse events|||Number
1336935|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient attendance of at least 3 out of 4 sessions on average.|8-month study period||||sessions||Standard Deviation|Mean
1336936|NCT01981356|Secondary|Experimental Treatment Feasibility|Assessed by our ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in random assignment to ACT + TAU or TAU.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.|||participants|||Number
1336937|NCT01981356|Secondary|Barriers and Facilitators to Implementation|We will conduct 30-60 minute semi-structured interviews structured around the RE-AIM framework (Glasgow et al., 1999), and utilizing the RE-AIM Planning Tool (Forman et al., 2010). The RE-AIM framework identifies, for example, barriers that limit patients, staff, and site participation in the intervention and how to address them, and provider and patient perceptions about why the intervention is successful at achieving better outcomes.|8-month study period|Data regarding barriers and facilitators was not obtained from patient participants, but was obtained from study staff, who were not assigned to treatment condition.|||Participants providing data|||Number
1336938|NCT01981356|Secondary|Cost of Stay|Obtained by: (a) obtaining length obtained by: (a) obtaining length-of-stay (in hours) on the inpatient unit for all study participants, (b) calculating the cost of stay for each participant by multiplying the length-of-stay by the dollar amount associated with inpatient treatment of psychosis (e.g., $1,297/day or $54/hour in 2011; Blow et al., 2011), and (c) summing the cost of stay across participants in each treatment condition.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Data regarding length of stay not available for one participant in each condition, both of whom had not been discharged by the end of the study period.|||Dollars||Standard Deviation|Mean
1336939|NCT01981356|Secondary|Positive and Negative Affect Scale (Watson et al., 1988)|Assesses short-term changes in global positive and negative affect in addition to changes in specific types of emotions (e.g., afraid, excited, guilty). Positive and negative affect subscales consist of ten items each, averaged to obtain scale scores. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (5) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (5) possible value on scale from baseline to follow-up. Increases in positive affect percentage change and decreases in negative affect change are considered better outcomes.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||percentage of total possible change||Standard Deviation|Mean
1336940|NCT01981356|Secondary|Acceptance and Action Questionnaire - II (Bond et al.., 2011)|Assesses changes in the primary mechanism thought to contribute to change in ACT: acceptance. All scale items were averaged to obtain a total scale score. Total scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Increases in percentage change are considered better outcomes (i.e., increased acceptance).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Acceptance and Action Questionnaire - II.|||percentage of total possible change||Standard Deviation|Mean
1336996|NCT01979952|Secondary|Respiratory Mortality at 6 Months|Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
1336941|NCT01981356|Secondary|Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)|Assesses changes in the frequency, believability, and associated distress of psychosis symptoms. Frequency, believability, and distress subscales consist of two items each, one assessing delusions and one assessing hallucinations, averaged to obtain subscale scores. Subscale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest to lowest possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest to highest possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced frequency, believability and distress).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Frequency, Believability, and Distress Symptom Scale.|||percentage of total possible change||Standard Deviation|Mean
1336942|NCT01981356|Primary|Brief Psychiatric Rating Scale (Overall & Gorham, 1962)|Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions). All scale items were averaged to obtain a total scale score. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced symptoms).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||percentage of total possible change||Standard Deviation|Mean
1336943|NCT01981057|Secondary|Osmolarity|"Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336944|NCT01981057|Secondary|Phosphorous|"Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336945|NCT01981057|Secondary|Magnesium|"Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336946|NCT01981057|Secondary|Calcium|"Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336947|NCT01981057|Secondary|Potassium|"Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336948|NCT01981057|Secondary|Sodium|"Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336949|NCT01981057|Secondary|Fat|"Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336950|NCT01981057|Secondary|Carbohydrates|"Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336951|NCT01981057|Secondary|Energy|"Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
1336952|NCT01981057|Primary|Protein|"Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations."|6 weeks||||g/kg/d||Full Range|Median
1336953|NCT01980992|Secondary|Incidence of All Serious Adverse Events During the Study.||1 year and 2 Years|Data was available for 22 participants in the Wheat OIT group and 21 participants for the Placebo Crossover group at the end of the study.|||Participants|||Count of Participants
1336954|NCT01980992|Secondary|Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group|The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).|2 Years|Two Placebo subjects did not crossover. This outcome measure is only for the Placebo crossover group.|||Participants|||Count of Participants
1336997|NCT01979952|Secondary|Respiratory Hospitalizations at 6 Months|Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
1336957|NCT01980992|Primary|The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.|Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.|1 Year|All randomized participants were included.|||Participants|||Count of Participants
1336958|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.|||Participants|||Number
1336959|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.|||Participants|||Number
1336960|NCT01980940|Secondary|Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)|The PGART is a self-administered questionnaire completed by participants. Participant assessment of response of arthritis to study medication was assessed on a 5-point Likert scale ('very well', 'well', 'fair', 'poor', and 'very poor').|Day 2, Day 4, Day 7, Day 11, Day 14, post-trial (up to Day 28)|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Percentage of participants|||Number
1336961|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale|The WOMAC VA 3.1 Physical Functioning subscale is a self-administered questionnaire assessing lower extremity physical function due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Physical Functioning subscale had 17 questions with answers to each item assessed on a 100 mm VA scale (0 = no difficulty; 100 = extreme difficulty). The score for each item was summed and the overall score ranged from 0 to 1700 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in physical function.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Units on a scale||Standard Deviation|Mean
1336962|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale|The WOMAC VA 3.1 Stiffness subscale is a self-administered questionnaire assessing lower extremity stiffness due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Stiffness subscale had two questions with answers to each item assessed on a 100 mm VA scale (0 = no stiffness; 100 = extreme stiffness). The score for each item was summed and the overall score ranged from 0 to 200 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in stiffness.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Units on a scale||Standard Deviation|Mean
1336963|NCT01980940|Primary|Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale|The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|Full analysis set (FAS) defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Units on a scale||Standard Deviation|Mean
1336964|NCT01980940|Primary|Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing|Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (AUC0-last) without any protocol violation that interferes with PK data interpretation|||mg||90% Confidence Interval|Least Squares Mean
1336965|NCT01980940|Primary|Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing|Tmax determined for the period up to 72 hours post-single application.|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Tmax) without any protocol violation that interferes with PK data interpretation|||hour||Full Range|Median
1336966|NCT01980940|Primary|Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing|Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Cmax) without any protocol violation that interferes with PK data interpretation|||mg||90% Confidence Interval|Least Squares Mean
1336967|NCT01980888|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336968|NCT01980888|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336969|NCT01980888|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336970|NCT01980888|Secondary|Nodal Response Rate|Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336971|NCT01980888|Secondary|Overall Response Rate|Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336972|NCT01980888|Primary|Progression-Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).|Up to 22 months|"Intent to Treat (ITT) analysis set: all participants who are randomized in the study with treatment group designated according to initial randomization.~Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments."|||months||95% Confidence Interval|Median
1336973|NCT01980875|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of obinutuzumab after the original scheduled date, the MRD assessment was performed no less than 12 weeks after the last dose of obinutuzumab. MRD negativity rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336974|NCT01980875|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336975|NCT01980875|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336976|NCT01980875|Secondary|Nodal Response Rate|Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336977|NCT01980875|Secondary|Overall Response Rate|Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336978|NCT01980875|Primary|Progression-Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
1336979|NCT01980628|Secondary|DOR (Duration of Response)|The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.|Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months.||||Months||95% Confidence Interval|Median
1336980|NCT01980628|Primary|ORR (Overall Response Rate)|"ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review comittee (IRC).~Per Cheson:~CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites."|Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months.||||Percentage of Participants||95% Confidence Interval|Mean
1336982|NCT01980589|Secondary|Time To Response (TTR)|Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Participants with an overall response|||months||Full Range|Median
1336983|NCT01980589|Secondary|Overall Response Rate (ORR)|Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Safety population|||percentage of participants||95% Confidence Interval|Number
1336984|NCT01980589|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.~Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:~Nonhematologic:~≥ Grade 3 non-hematological toxicity~≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours~Hematologic:~Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days~Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration~Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment~Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding"|First cycle treatment over 28-days|The Safety population is defined as all enrolled participants who received any study treatment.|||participants|||Number
1336985|NCT01980524|Other Pre-specified|Stroke Volume|Stroke volume before and after administration of acipimox or placebo|180 minutes||||ml/m2||Standard Deviation|Mean
1336986|NCT01980524|Secondary|Ejection Fraction|Left ventricular ejection fraction before and after administration of acipimox or placebo|180 minutes||||percentage||Standard Deviation|Mean
1336987|NCT01980524|Primary|MYCL|Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo|180 minutes||||percentage of water signal||Standard Deviation|Mean
1336988|NCT01980342|Secondary|Cervical Mucus Quality|Cervical mucus quality will be assessed twice weekly throughout the study period. The etonogestrel implant exerts a secondary contraceptive effect by causing cervical mucus to become thick and sticky, and therefore less permissive to the movement of sperm through the female genital tract. We will assess whether efavirenz causes a change in cervical mucus quality that would make sperm penetration more likely, and therefore indicate a reduction in the implant's contraceptive effect.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
1336989|NCT01980342|Secondary|Transvaginal Ultrasound to Assess for Ovarian Follicular Development|For the entire 6 week period of the study, participants will undergo twice-weekly transvaginal ultrasound to assess for the development of ovarian follicles. This direct assessment of follicular development will be combined with serum hormone concentrations to determine if efavirenz increases the incidence of ovulation in women using the etonogestrel implant for contraception.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
1336990|NCT01980342|Secondary|Serum Hormone Markers of Ovulation|We will test serial blood samples for levels of luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol, and progesterone to determine whether the etonogestrel implant is able to suppress ovulation during and after a course of efavirenz.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
1336991|NCT01980342|Secondary|Serum Efavirenz Concentrations at the Start and End of the 2-week Dosing Period|We will assess serum efavirenz concentrations at the beginning and end of the 2-week dosing period. By comparing these concentrations to historical controls, we will determine whether taking efavirenz while using the etonogestrel implant alters the serum concentration of efavirenz.|2 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
1336992|NCT01980342|Primary|Serum Concentration of Etonogestrel Before and After Two Weeks of Efavirenz|We will draw a baseline serum etonogestrel immediately prior to a participant starting the 2-week course of efavirenz. Serial blood samples will subsequently be drawn over the next 6 weeks to assess for changes in serum etonogestrel concentration. We will be looking to see if the serum etonogestrel concentration decreases below the level necessary for reliable ovulation suppression.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
1336993|NCT01980095|Other Pre-specified|H. Pylori Eradication|The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment|28-56 days after completion of SOC treatment||||Participants|||Count of Participants
1336994|NCT01980095|Primary|The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing|Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.|28-56 days after completion of treatment||||Participants|||Count of Participants
1336995|NCT01979952|Secondary|Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months|Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
1336998|NCT01979952|Secondary|All-cause Mortality at 6 Months|Percentage of subjects died from all causes between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
1336999|NCT01979952|Secondary|University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months|"University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6)."|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||Units on a scale||Standard Error|Least Squares Mean
1337000|NCT01979952|Secondary|6MWT Total Distance Walked Change From Baseline at 6 Months|"Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented.~The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria."|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||meters||Standard Error|Least Squares Mean
1337001|NCT01979952|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months|"SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6)."|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||Units on a scale||Standard Error|Least Squares Mean
1337002|NCT01979952|Secondary|Categorical Change in FVC From Baseline at 6 Months|Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented.|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||Percentage of participants|||Number
1337003|NCT01979952|Secondary|Relative Change in FVC From Baseline at 6 Months|Relative change in FVC from baseline at 6 months is presented.|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||percentage of change||Standard Error|Least Squares Mean
1337004|NCT01979952|Secondary|Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months|Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented.|Baseline and 6 Months|Treated Set (TS) (Only patients with observed cases (OC) values were analysed)|||milliliter (mL)||Standard Error|Least Squares Mean
1337005|NCT01979952|Secondary|Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months|"Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable.~HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment."|Baseline and 12 Months|Observed Cases (12 months) (OC12): The OC12 consisted of all patients in OC6 with observed QLF data at 12 months.|||percent change||Standard Error|Least Squares Mean
1337006|NCT01979952|Primary|Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months|Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.|Baseline and 6 Months|Observed Cases (6 months) (OC6): The OC6 consisted of all patients in the TS (all patients who were randomized to a treatment group and received at least 1 dose of study drug) with observed data for the primary endpoint (relative change from baseline in HRCT QLF score at 6 months).|||percent change||Standard Error|Least Squares Mean
1337007|NCT01979445|Secondary|Bleeding Events In Accordance With GUSTO Scale|"Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Day 1. Reports of bleeding were to be evaluated by performance of a CBC. Participants were assessed for bleeding events in accordance with the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scale.~The severity of bleeding events by GUSTO Criteria is defined as the following:~Severe/life-threatening: fatal, intracranial hemorrhage, or if hemodynamic compromise results~Moderate: transfusion required~Mild: no transfusion or hemodynamic compromise~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Screening through the follow-up period (5 to 7 days after Day 1)|Safety Population included all participants who received at least 1 dose of study drug.|||bleeding events|||Number
1337008|NCT01979445|Secondary|Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay|A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by PRU, determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cAMP. Platelet reactivity was expressed in PRU.|Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||PRU||Standard Deviation|Mean
1337125|NCT01977677|Primary|Dose-limiting Toxicity|Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)|Up to 30 days post plerixafor||||Participants|||Count of Participants
1337009|NCT01979445|Secondary|Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay|A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by platelet reaction units (PRU), determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cyclic adenosine monophosphate (cAMP). Platelet reactivity was expressed in PRU.|Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||PRU||Standard Deviation|Mean
1337010|NCT01979445|Primary|Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone|A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).|Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
1337011|NCT01979445|Primary|Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone|A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).|Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
1337012|NCT01979276|Secondary|Time to Disease Progression (Progression Free Survival)||From start of treatment, to date of disease progression (on average, ten 28-day cycles)||||cycles (defined as 28 days)||Full Range|Mean
1337013|NCT01979276|Primary|Efficacy of Study Regimen Combination|The efficacy (as assessed by clinical response) of the combination of pomalidomide (CC-4047®) and romidepsin as therapy for patients with relapsed or refractory multiple myeloma (MM) (phase II portion) was evaluated using the IMWG Response Criteria for disease assessment. The best response was reported. (Criteria can be found at the following link, due to length and complexity of the response criteria: http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/)|From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days||||Participants|||Count of Participants
1337014|NCT01979276|Primary|Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone|Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I)|During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)|MTD not established as study terminated while only 2 subjects enrolled. Only romidepsin dose tested was 9mg/mg2||||||
1337015|NCT01979185|Primary|Maximum Plasma Concentration (Cmax) of Simvastatin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
1337016|NCT01979185|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/ml||Standard Deviation|Mean
1337017|NCT01979185|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/ml||Standard Deviation|Mean
1337018|NCT01979133|Primary|Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)|"The YMRS is an 11-item observer-rated measure of mania symptomatology:~7 individual items are scored between 0-4.~4 individual items are scored between 0-8.~Total score range is 0-60, with no subscales. Higher score is indicative of more manic symptoms. Lower score represents better outcomes.~Total score is obtained by adding items on the scale together."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||YMRS units on a scale||Standard Deviation|Mean
1337019|NCT01979133|Primary|Change in Days of Alcohol Use From Baseline to Week 8 (Exit)|"Total score range is 0-7 (no days of alcohol use - 7 days of alcohol use). The lower score represents better outcome.~Participants are asked to identify days on which they used alcohol in the past week (not including the day of visit)."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||Days Per Week||Standard Deviation|Mean
1337020|NCT01979133|Primary|Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)|"Heavy drinking day is defined as 5 standard drinks per day for men, and 4 standard drinks per day for women.~Minimum score is 0 (no drinks); maximum score is unique to each individual participant. Lower score represents a better outcome.~Average number of heavy drinking days per week is calculated by asking participants to identify the number of drinks they had on each day during the past 7 days (not including the day of visit).~See outcome measure description for standard drinks per week for standard drinks convention."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||Days Per Week||Standard Deviation|Mean
1337021|NCT01979133|Primary|Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)|"Participants are asked to identify the number of alcoholic drinks they consumed on each day within the last 7 days from the day of visit (not including the day of visit). Participants are asked to provide alcohol name and the amount of alcohol they consumed. These values are then converted to standard drinks using a standard drinks calculator.~The minimum number of drinks per week is 0. There is no maximum number of drinks per week, as the maximum number is unique to each participant.~The general convention for standard drinks used in this study is as follows (oz per one standard drink):~beer: 12 fl oz (5% ABV)~wine: 5 fl oz (10-12% ABV or 18-20% ABV for fortified wine)~hard liquor: 1.5 fl oz (40% ABV)"|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||Drinks per week||Standard Deviation|Mean
1337022|NCT01979133|Primary|Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8|"The QIDS is a 16-item self-report measure of depressive symptomatology:~16 items rated on a scale from 0-3. No subscales for this instrument.~Total score range is 0-27, where higher score represents higher levels of depression. Lower scores associated with better outcomes.~Total score is obtained using the following formula: highest score on items 1-4 + item 5 + highest score on items 6-9 + item 10+item 11+item12+item13+item14+highest score on items 15-16"|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||QIDS units on a scale||Standard Deviation|Mean
1337023|NCT01979133|Primary|Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)|"HAMA is a 14-item observer rated measure of anxiety symptomatology:~14 items in a scale, no subscales. Individual items are score 0 (no anxiety) to 4 (very severe anxiety).~Total scores range from 0-56.~Total scores represent more severe anxiety. Lower scores represent a better outcome."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a results, the overall number of participants analyzed was 9.|||HAMA units on a scale||Standard Deviation|Mean
1337024|NCT01979133|Primary|Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)|"HAMD is an observer-rated measure of depressive symptomatology:~17 questions (answers for individual questions range between 0-3 and 0-4). Total score range: 0-52. No subscales for this measure.~0 - no depression; 52 - very severe depression (lower score corresponds to a better outcome).~Total score is obtained by summing questions 1-17."|Baseline vs. Week 8 (Exit)|The total enrollment goal was 10. One participant dropped out during the baseline II visit, thus week 8 score was not obtained for that participant and the change from baseline to week 8 could not be collected. Thus, the analysis includes 9 participants instead of proposed 10.|||HAMD scale units||Standard Deviation|Mean
1337025|NCT01979029|Other Pre-specified|Systemic Blood Pressure||after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon||||mmHg||Standard Deviation|Mean
1337026|NCT01979029|Secondary|Distal Colon Length||after digestive tract reconstruction||||cm||Standard Deviation|Mean
1337027|NCT01979029|Primary|The Blood Pressure of the Arterial Arcade||after ligating the inferior mesentric artery or superior rectal artery||||mmHg||Standard Deviation|Mean
1337028|NCT01978743|Secondary|Change in Level of EFV and Metabolites|Correlate change in level of EFV and metabolites with neurocognitive and neuroimaging changes|week 0 and week 8|Level of EFV (efavirenz) in Atripla and its two known metabolites known to cause cerebral side effects, 7-hydroxy (OH) EFV and 8-OH EFV, were measured in the plasma prior to switch off Atripla and after 8 weeks of RAL-based regimen (no EFV).|||participants|||Number
1337029|NCT01978743|Secondary|Markers of Immune Activation|Change in markers of immune activation and inflammation associated with change to RAL (ie, sCD14, IL-6, hsCRP, D-dimer, CRP, LPS, sCD163, EndoCab)|week 0 and week 8||||pg/ml||Standard Deviation|Mean
1337030|NCT01978743|Secondary|ART Regimen Preference|Evaluate patient preference in ART regimen (Atripla, EFV/FTC/TDF versus RAL + FTC/TDF) through self-administered questionnaires.|week 0 and week 8|Each participant was asked a single self-administered question on their ART preference and asked to chose one of the 3 answers; 1. prefer to take Atripla, 2. prefer RAL-based regimen (that they received in study) or 3. no preference.|||participants|||Number
1337031|NCT01978743|Secondary|Sleep Quality|Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality.|week 0 and week 8||||units on a scale||Standard Deviation|Mean
1337032|NCT01978743|Secondary|Fasting Lipid Profile|Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen.|week 0 and week 8|Change in lipid panel pre- and post-switch to RAL-based regimen|||mg/dL||Standard Deviation|Mean
1337033|NCT01978743|Secondary|Neurocognitive Changes Measured by a Panel of Indexes: WAIS-R, HAMD, DASS-21, FRSBE, STAI|"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain dmamage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80."|week 0 and week 8||||units on a scale||Standard Deviation|Mean
1337034|NCT01978743|Secondary|Other Neurometabolite Changes Measured by MRS|Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) to evaluate for prominent and significant changes associated with EFV use.|week 0 and week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
1337035|NCT01978743|Primary|Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)|Assess changes in neural activation correlated with affective disturbances associated with EFV vs. RAL using fMRI employing a paradigm that probes affective symptomatologies typical with EFV use; anxiety/dysphoria and affective dysregulation, and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-/Post-/ Pre-vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect, and Age incorporated as a co-variate of no interest. A z-score is the Mean with a SD=1 and Measure of Dispersion equal to 1.|week 0 and week 8|8 of 10 enrolled patients passed QA testing to qualify for final fMRI data analyses. The 3 linear contrasts of Pre-switch/Post-switch/Pre- vs. Post-switch: [Neg vs.Neu] x [No-Go vs. Go] are reported as z-score (standardized effect size measures with SD=1). Z-score is obtained for each subject, group Z-score is obtained via a mixed-effects model.|||z-score|||Number
1337036|NCT01978743|Primary|Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)|Assess the levels of neuro-metabolites measured by MRS at week 0 before switching to the efavirenz-based therapy. Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain creatine (Cr), gamma-aminobutyric acid (GABA) and glutathione (GLU).|week 0 and week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
1337037|NCT01978600|Secondary|Mean 24-hour IOP at Week 4|24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
1337038|NCT01978600|Secondary|Mean Diurnal IOP at Week 4|Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
1337039|NCT01978600|Primary|Mean Nocturnal IOP at Week 4|Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
1337040|NCT01978535|Primary|Cardiovascular Indices-interval Change in Heart Rate During 10-minute Head up Tilt Table Test|This study will assess whether a single infusion of iron sucrose will improve cardiovascular indices, specifically a reduction in the interval of measured heart rate change, during a ten minute head up tilt, in adolescent subjects with POTS and non-anemic iron deficiency|7 (+/- 2) days following intervention|The outcome measure was not analyzed because there were insufficient data.||||||
1337041|NCT01978314|Secondary|To Evaluate the Correlation Between FAST’s Plasma Volume Method and Standard Clinical Estimates of Plasma Volume.|This analysis will compare estimates of plasma volume derived by FAST's plasma volume method with that derived using the conventional Nadler's Formula for plasma volume.|Baseline through day 22||||mL||Standard Deviation|Mean
1337042|NCT01978314|Secondary|To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods.|This analysis will compare estimates of kidney function derived from the results of FAST VFI™ to those derived through conventional Iohexol clearance methods.|Baseline through Day 22|The subject in Cohort 4 did not receive Iohexol. One subject in Cohort 5 withdrew from the study before receiving Iohexol. Samples were missing for 1 subject in each of Cohorts 1 and 3.|||mL/min||Standard Deviation|Mean
1337613|NCT01972464|Secondary|7-day Point Prevalence of Abstinence at End of Treatment (Week 8)|Abstinence was defined as self-report of no smoking in the past 7 days confirmed by a negative urine cotinine test (urine cotinine <100 ng/ml).|Week 8 of the trial period||||Participants|||Count of Participants
1337043|NCT01978314|Secondary|AUCinf/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUCinf/Dose = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)/Dose|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||[(ng∙hr/mL)/(mg/m^2)]||Standard Deviation|Mean
1337044|NCT01978314|Secondary|Cmax/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Cmax/Dose = maximum observed concentration occurring at Tmax/Dose|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||[(ng/mL)/(mg/m^2)]||Standard Deviation|Mean
1337045|NCT01978314|Secondary|CL of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|CL = total body clearance|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||mL/hr/m^2||Standard Deviation|Mean
1337046|NCT01978314|Secondary|Vss of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Vss = volume of distribution at steady state|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||mL/m^2||Standard Deviation|Mean
1337047|NCT01978314|Secondary|Vz of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Vz = volume of distribution based upon terminal phase|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||mL/m^2||Standard Deviation|Mean
1337048|NCT01978314|Secondary|T1/2, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|T1/2 = terminal half-life = ln(2)/λz|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||hr||Standard Deviation|Mean
1337049|NCT01978314|Secondary|AUCinf of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUCinf = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng∙hr/mL||Standard Deviation|Mean
1337050|NCT01978314|Secondary|AUCall of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUCall = area under the concentration-time curve (time 0 to last scheduled sample)|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng∙hr/mL||Standard Deviation|Mean
1337051|NCT01978314|Secondary|AUClast of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUClast = area under the concentration-time curve (time 0 to last sample with a quantifiable measurable concentration)|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng∙hr/mL||Standard Deviation|Mean
1337052|NCT01978314|Secondary|Tmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Tmax = time of maximum observed concentration|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||hr||Standard Deviation|Mean
1337053|NCT01978314|Secondary|Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Cmax = maximum observed concentration occurring at Tmax|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng/mL||Standard Deviation|Mean
1337054|NCT01978314|Primary|Number of Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product or investigational medical device.|Baseline through day 22|Intent-to-treat subject population|||adverse events|||Number
1337055|NCT01978314|Primary|Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product or investigational medical device.|Baseline through day 22|Intent-to-treat subject population|||participants|||Number
1337056|NCT01978236|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE were collected from the time the first dose of study treatment is administered until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy using Medical Dictionary for Regulatory Activities (MedDRA)|Up to 2 years|Safety Set Population The Safety Set comprised of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
1337057|NCT01978236|Secondary|Number of Participants With Abnormal Clinical Laboratory Assessments|Laboratory assessments included parameters like Hematology, Standard Chemistry, Coagulation, Serum Pregnancy. Assessment of these parameters were planned to be performed by the central laboratory on screening, Day prior to surgery, Every 4 weeks after restart and Discontinuation, but were not analyzed as the study was terminated due to low enrollment.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337058|NCT01978236|Secondary|Number of Participants With Abnormal Echocardiogram (ECHO)|ECHO include an evaluation for Left ventricular ejection fraction (LVEF) and both right- and left-sided valvular lesions. ECHO was planned to be performed at screening, Week 8 and every 16 weeks till discontinuation. data for ECHO was not summarized and listed as the study was terminated.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337059|NCT01978236|Secondary|Number of Participants With Abnormal 12-lead Electrocardiograms (ECG)|112-lead ECGs were planned to be obtained at screening during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. At each assessment a 12-lead ECG was planned to be performed by qualified personnel at the site after at least a five-minute rest with the participants in a semi-recumbent or supine position. But data for 12-lead ECGs were not summarized and listed as the study was terminated.|Screening|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337060|NCT01978236|Secondary|Number of Participants With Abnormal Physical Examinations|A complete physical examination was planned which included assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. Height and weight was also planned to be measured and recorded. A complete physical exam including a thorough genitourinary examination for female participants, inspection of the head and neck region, and digital rectal examination for both male and female participants was planned to be performed at Screening, and Month 12 or at discontinuation if discontinuation occurs prior to Month 12. If the participants had a genitourinary and rectal exam within 6 months of screening, these assessments need not to be repeated at screening. But data for physical examinations were not summarized and listed as the study was terminated.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337061|NCT01978236|Secondary|Number of Participants With Abnormal Vital Signs|Vital sign measurements including temperature, respiratory rate, systolic and diastolic blood pressure, and pulse rate were planned to be performed but were neither summarized nor listed as the study was terminated.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337062|NCT01978236|Secondary|Percentage of Participants With Overall Survival|Overall survival, defined as the time from first dose of study treatment to death for any reason, was planned to summarize using Kaplan-Meier quartile estimates along with two sided 95% confidence intervals. But were not performed as the study was terminated due to low enrollment.|Approximately 2 years or death whichever occurs first|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337063|NCT01978236|Secondary|Percentage of Participants With Overall Extracranial Response Rate in Unresected Lesions|Overall Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime as per modified Response Evaluation Criteria in Solid Tumors (RECIST). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence and is determined programmatically based on the investigator’s assessment of response at each time point. Overall Extracranial Response Rate was planned but not analyzed as the study was terminated due to low enrollment.|Approximately 2 years or death whichever occurs first|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337064|NCT01978236|Secondary|Maximum Percent Change From Baseline in the SLD of Unresected Intracranial Target Lesions|The maximum change from Baseline in the SLD of unresected intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337065|NCT01978236|Secondary|Percent Change From Baseline to Pre-surgery in the Sum of the Longest Diameters (SLD) of Intracranial Target Lesions|The change from Baseline to the pre-surgery intracranial disease assessment in the SLD of intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337066|NCT01978236|Secondary|Number of Participants With Changes in Radiographic Tumors|Changes in the radiographic characteristics of the tumors were planned to be compared to (1) levels of dabrafenib, its metabolites and trametinib (where appropriate) in the brain metastases, plasma, and CSF, and (2) MAPK pathway activation status in tumors at the time of surgery. Results were planned to be compared to the analysis of early clinical responses in extracranial metastases, as determined by the Positron emission tomography (PET-CT) imaging. This analysis was planned but not performed as the study was terminated due to low enrollment|Up to 2 years|Full Analysis Set. Analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337067|NCT01978236|Secondary|Number of Participants With Changes in Mitogen-activated Protein Kinase (MAPK) Pathway Markers|Changes in MAPK pathway markers in paired extracranial biopsies taken pre-treatment, during craniotomy, and at disease progression, and changes in markers between post-operative intracranial and extracranial biopsies was planned but not performed as the study was terminated due to low enrollment.|Up to Day 15|Full Analysis Set. Analysis was planned but not performed as the study was terminated due to low enrollment.||||||
1337068|NCT01978236|Secondary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) in Cerebrospinal Fluid (CSF) Samples|Concentrations of dabrafenib, its metabolites hydroxy-, carboxy- and desmethyl-dabrafenib) and trametinib in CSF (in participants who agree for optional collection of CSF at the time of brain tumor resection). Optional collection of CSF was obtained in the operating room on the day of brain metastasis resection. CSF samples for only one participant were collected and analyzed.|Day 15|Pharmacokinetic Analysis Set|||ng/mL|||Number
1337069|NCT01978236|Primary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) and Trametinib (Cohort B Only) in CSF Samples.|Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib and trametinib (as appropriate), were planned but not collected.|Pre-surgery and post-surgery on Day 15|Pharmacokinetic Analysis Set||||||
1337070|NCT01978236|Primary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Parenchymal Brain Metastases|Concentrations of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib, and possibly other drug-related species were quantified in the pharmacokinetic tissue sample by an investigative Liquid chromatography- mass spectrometry (LC-MS)/MS method. The spatial distribution of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib and possibly other drug-related species in the tissue samples were determined using an investigative matrix assisted laser desorption ionization (MALDI) analysis method. Parenchymal brain metastases and extracranial metastases using MALDI imaging was not determined for all participants (completed by GSK for the first two participants enrolled)|Day 15|Pharmacokinetic Analysis Set|||ng/mL|||Number
1337071|NCT01978236|Primary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Peripheral Blood (Plasma)|Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib were collected on day of surgical resection of the brain metastasis(es), Two samples were collected before surgery and 2 samples after surgery with one hour gap in between. Upon collection blood was placed on wet ice. Plasma was isolated within 60 minutes of collection and frozen at -20 degree celsius.|Pre-surgery and post-surgery on Day 15|The Pharmacokinetic analysis set included all participants who provided at least one evaluable Pharmacokinetic concentration.|||Nano grams per milliliter (ng/mL)|||Number
1337072|NCT01978145|Secondary|Change From Baseline in COPD Assessment Test (CAT) Scores at Week 12|The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items, each formatted on a semantic differential scale. Participants rated their experience on a 6-point scale for each question, ranging from 0 to 5 with a maximum total score of 40. Higher scores indicate greater disease impact. CAT of each participant was assessed at Baseline (Day 1) and Week 12 (Day 85) of each treatment period. Change from Baseline within each period was calculated as values at Week 12 minus period specific Baseline value. The change from Baseline in CAT overall score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline CAT overall score, adjusted treatment period specific Baseline CAT overall score, treatment group, treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1337073|NCT01978145|Secondary|Change From Baseline in St George’s Respiratory Questionnaire-COPD (SGRQ C) Score at Week 12|The SGRQ-C is a 40-item COPD-specific questionnaire designed to measure the effect of COPD and its treatment on the participant’s health-related quality of life (HRQoL). The SGRQ-C includes 14 questions with a total of 40 items grouped into three components (symptoms, activity, and impacts). Each questionnaire response has a unique empirically derived weight. The lowest possible weight is zero and the highest is 100. Higher scores indicate greater impairment of HRQoL. HRQoL of participants was assessed using the SGRQ-C at Baseline (Day 1) and Week 12 of each treatment period. Change from Baseline was calculated as value at Week 12 minus the period specific Baseline value. Change from Baseline in SGRQ total score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline SGRQ total score, adjusted treatment period-specific Baseline SGRQ total score, treatment group, and treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1337096|NCT01978093|Secondary|Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL|The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|2 month post-dose 2 of Rotarix (Month 4)|The analysis was performed on the Rota ATP cohort for analysis of immunogenicity which included all vaccinated subjects for whom data were available.|||Percentage of subjects||95% Confidence Interval|Number
1337665|NCT01971723|Primary|Blood Lipid Outcomes|Measurements for blood lipid panels will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||mg/dl||Standard Deviation|Mean
1337074|NCT01978145|Secondary|Change From Baseline in Transition Dyspnoea Index (TDI) Focal Score at Days 28, 56 and 85|Baseline Dysponea Index (BDI) and Transition Dyspnoea Index (TDI) are interview-based measurements of breathlessness due to COPD related daily living activities. Scores depend on ratings for 3 categories: functional impairment, magnitude of task and magnitude of effort. BDI was collected at Day 1 and TDI at Days 28, 56 and 85 of each treatment (trt) period. Each BDI scale has 5 possible scores ranging from 0 to 4, with 0 (worst) to 12 (best) as the total range. Each TDI scale has 7 possible scores ranging from -3 to +3, with -9 (worst) to +9 (best) as the total range. TDI focal score >=1 is considered to be a clinically meaningful change. Change from Baseline was calculated as TDI minus BDI values. Analysis was performed using MMRM by par. level BDI focal score, adjusted period-specific BDI focal score, trt group, trt period, visit, visit*trt group, visit*par. level BDI focal score, visit*adjusted period-specific BDI focal score as a fixed effect and with par. as a random effect.|Baseline, and Days 28, 56 and 85|ITT population. Only those participants available at the specified time points were analyzed (n=X, X in the category title).|||Scores on a scale||Standard Error|Least Squares Mean
1337075|NCT01978145|Secondary|FEV1 Area Under the Curve From 0 to 10 Hours (AUC [0-10]) on Day 85 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1. The FEV1 was measured on Day 85 of each treatment period at time 0 (predose),15 minutes, 30 minutes, 1, 2, 4, 6, and 10 hours post morning dosing for determination of AUC 0 to10 hours. The AUC was analyzed using a mixed effects analysis of covariance (ANCOVA) with participant-level Baseline (Day 1 trough FEV1), adjusted period-specific Baseline (Day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.|||Liter*hours||Standard Error|Least Squares Mean
1337076|NCT01978145|Secondary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 28 and 56|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 at Days 28 and 56 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Days 27 and 55). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Days 28 and 56 of each treatment period|Intent-to-Treat (ITT) Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Liters (L)||Standard Error|Least Squares Mean
1337077|NCT01978145|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Day 85 of each treatment period|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomized study treatment in the treatment period. Only those participants available at the specified time points were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
1337078|NCT01978119|Secondary|Change From Baseline in the Percentage (%) of Rescue-free Days Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|A rescue-free day is defined as a 24-hour period with no rescue medication usage recorded (i.e. both the day-time and night-time numbers of puffs of Salbutamol/Albuterol are zero). Percentage of Rescue-Free Days was calculated over each 12-week Treatment Period, dividing the number of rescue-free days by the length of the TP. The BL value of change from BL in % rescue free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from BL was the difference over 12 weeks for each treatment period compared to BL. The change from BL in the % of rescue medication-free days averaged over the 12-week TP was analyzed, using mixed effects ANCOVA model, with par level BL % of rescue-free days, adjusted period-specific BL % of rescue-free days treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Percentage of rescue-free days||Standard Error|Least Squares Mean
1337079|NCT01978119|Secondary|Change From Baseline in Asthma Control Test (ACT) Over 12 Weeks for Each Treatment Period|The ACT is a 5-item questionnaire with a score of 1 to 5 for each item (1=poor control and 5=good control). The scores from each question were added to give an overall score. Baseline was defined as the value obtained predose (0 minutes) on day 1 of each Treatment Period. Change from Baseline was the difference in ACT score at the timepoint compared to Baseline score. The change from Baseline in overall ACT score was analysed, using mixed effects ANCOVA model, with participant level Baseline overall ACT score, adjusted period-specific Baseline overall ACT score, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Scores on the scale||Standard Error|Least Squares Mean
1337124|NCT01977677|Primary|Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation|Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.|6 months from start of irradiation||||Participants|||Count of Participants
1337080|NCT01978119|Secondary|Change From Baseline in the Percentage of Symptom-Free Days From Paper Diary Card Over 12 Weeks|A Symptom-Free day was defined as a 24-hour period with no symptoms recorded. Percentage of Symptom-Free Days was calculated dividing number of Symptom-Free days by the length of the Treatment Period. The baseline value of change from baseline in % of symptom free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from Baseline was the difference in percentage of Symptom-Free days at week 12 compared to Baseline. The change from Baseline in the percentage of Symptom-Free days averaged over the 12-week Treatment Period was analyzed, using mixed effects ANCOVA model, with participant level Baseline percentage of Symptom-Free days, adjusted period-specific Baseline percentage of Symptom-Free days, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Percentage of symptom-free days||Standard Error|Least Squares Mean
1337081|NCT01978119|Secondary|Change From Baseline in Day-time(AM) and Night-time (PM) Asthma Symptoms(Sy) From Paper Diary Card (PDC) Over 12 Weeks(wk) for Each Treatment Period(TP)|AM Sy scores were recorded nightly on PDC using the scale:0=No Sy during day,1=Sy for one short period during day,2=Sy for two or more short periods during day,3=Sy for most of day-not affecting normal daily activities,4=Sy for most of day-did affect normal daily activities,5=Sy so severe-could not go to work or perform normal daily activities. Similarly, PM Sy scores were recorded every morning using the scale:0=No Sy during night,1=Sy causing me to wake once(or early),2=Sy causing me to wake twice or more(or early),3=Sy causing me to be awake most of night,4=Sy severe-did not sleep. BL= average of last 4 available of the last 7 days of Screening Period(TP 1) and of Washout Period(TP 2). Change from BL in average of daily scores=difference over 12 wks for each TP compared to BL. AM and PM Sy Scores were separately averaged over each of the two 12-wk TP. Total value of each endpoint over 12-wk TP was divided by number of days with non-missing data to obtain an average for each subject|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.|||Scores on the scale||Standard Deviation|Mean
1337082|NCT01978119|Secondary|Change From Baseline (BL) in Rescue Medication Use Over 12 Weeks (From Paper Diary Card) for Each Treatment Period (TP)|Rescue medication usage for each 24-hour period is defined as the total numbers of puffs of Salbutamol/Albuterol within 24 hours (i.e. number taken during the day and number taken during the night). The total usage over the 12 week TP was divided by the number of days with nonmissing rescue medication data to get an average usage per participant. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). Change from BL in average usage of rescue medication was the difference over 12 weeks for each TP compared to BL. The change from BL in the percentage of rescue medication use averaged over the 12-week TP was analysed using mixed effects ANCOVA model, with par level BL rescue medication use, adjusted period-specific BL rescue medication use, treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Puffs per day||Standard Error|Least Squares Mean
1337083|NCT01978119|Secondary|Change From Baseline (BL) in Morning Peak Expiratory Flow Rate (PEFR) Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|The PEFR is a paricipant’s(par) maximum speed of expiration, as measured with a peak flow meter(PFM). All par were issued a PFM and instructed to perform the activity in triplicate in the morning prior to taking the bronchodilator. The best among the 3 readings was selected. Efficacy measurement was recorded by the par in the paper Diary Card for morning PEFR. The total PEFR over the 12 week TP was divided by the number of days with non-missing PEFR data to obtain an average for each par. Change from BL in average morning PEFR is the difference over 12 weeks for each TP compared to BL. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). The change from BL in the PEFR averaged over the 12-week TP was analysed using a mixed effects ANCOVA model with participant level BL PEFR, adjusted period-specific BL PEFR, treatment group, and period as fixed effects, and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Liters per minute||Standard Error|Least Squares Mean
1337084|NCT01978119|Secondary|Change From Baseline in Morning Trough FEV1 at Day 28 and Day 56|Pulmonary function was measured by FEV1, a measure of lung function, and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry at predose (Baseline), on Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on Day 1of each Treatment Period. Change from Baseline within each period was calculated as trough FEV1 at Day 28 and 56 minus the period specific Baseline value.The change from Baseline in trough FEV1 at Day 28 and Day 56 was analysed via the primary analysis model. Least Squares mean values for the change from Baseline in trough FEV1 at Day 28 and Day 56 were obtained from the primary analysis model (for each treatment and for the treatment difference), and displayed alongside corresponding 95% confidence intervals.|Baseline, Day 28, and Day 56|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.|||Liter||Standard Error|Least Squares Mean
1337085|NCT01978119|Secondary|FEV1 AUC (0-12) at Day 85 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.|||Liter*hours||Standard Error|Least Squares Mean
1337086|NCT01978119|Secondary|FEV1 Area Under the Curve From 0 to 12 Hours (AUC [0-12]) on Day 1 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 1 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.|||Liter*hours||Standard Error|Least Squares Mean
1337087|NCT01978119|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analysed using Mixed Model for Repeated Measures analysis, having fixed effect Participant level Baseline, Adjusted period-specific Baseline, Treatment group, Period, Visit, Visit by treatment, Visit by Participant level Baseline, Visit by Adjusted period-specific Baseline, with participant as a random effect.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomised study treatment in the Treatment Period. Only those participants available at the specified time points were analyzed.|||Liter||Standard Error|Least Squares Mean
1337088|NCT01978093|Secondary|Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 17-20)|The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
1337089|NCT01978093|Secondary|Percentage of Subjects Reporting Any Unsolicited AEs.|Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event.|During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)|The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
1337090|NCT01978093|Secondary|Percentage of Subjects Reporting Any Solicited General AEs.|Solicited general AEs include fever [defined as temperature ≥38.0 degrees Celsius (°C) by any method], drowsiness, irritability/fussiness and loss of appetite.|4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.|The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
1337091|NCT01978093|Secondary|Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE).|Solicited local adverse events include pain, redness and swelling at injection site.|4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose|This analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose total vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
1337092|NCT01978093|Secondary|Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups|1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)|This analysis was perfomed on First three doses ATP for analysis of immunogenicity and on the Fourth dose ATP cohort for analysis of immunogenicity which included all evaluable subjects for whom data were available.|||Percentage of subjects||95% Confidence Interval|Number
1337093|NCT01978093|Secondary|GMCs for Anti-HAV Antibodies ≥15mIU/mL.|The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups|1 month post-dose 2 of HAV (Month 17-20).|This analysis was performed on Havrix ATP cohort for analysis of immunogenicity which included all evaluable subjects who have received the first and second dose of Havrix and for whom assay results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1337094|NCT01978093|Secondary|Anti-HAV GMCs ≥ 15 mIU/mL|The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups|1 month post-dose 1 of HAV (M11-14).|The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1337095|NCT01978093|Secondary|Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL|The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|1 month post-dose 1 of Havrix (Month 11-14)|The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.|||percentage of subjects||95% Confidence Interval|Number
1337666|NCT01971723|Primary|Insulin Outcomes|Measurements of insulin will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ulU/ml||Standard Deviation|Mean
1337097|NCT01978093|Secondary|Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY|The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.|||Titres||95% Confidence Interval|Geometric Mean
1337098|NCT01978093|Secondary|Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32.|The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
1337099|NCT01978093|Secondary|Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL|The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) which included all evaluable subjects for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
1337100|NCT01978093|Secondary|Anti-PRP GMCs≥ 0.15 µg/mL.|"Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups."|2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1337101|NCT01978093|Secondary|Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.|The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
1337102|NCT01978093|Primary|Anti-S. Pneumoniae GMCs|"Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch"|1 month post-dose 4 of Prevnar 13 (Month 11-14)|The analysis was performed on the Forth dose ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received four doses of Prevnar 13 vaccine and for whom immunogenicity results were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1337103|NCT01978093|Primary|Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL|"Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch"|1 month post-dose 2 of Havrix (Month 17-20)|The analysis was performed on the Havrix ATP cohort for analysis of immunogenicity which include all evaluable subjects who received two doses of Havrix vaccine and for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
1337126|NCT01977625|Secondary|Change in BADDS Total Score|The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated.|10 weeks|Participants who completed all 3 scans.|||change in units||Standard Deviation|Mean
1337104|NCT01978093|Primary|Anti-Streptococcus (S) Pneumoniae GMCs|"Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch."|1 month post-dose 3 of Prevnar 13 (Month 5)|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received three doses of Prevnar 13 vaccine and for whom immunogenicity results were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1337105|NCT01978093|Primary|Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).|"Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.~Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch"|2 months post-dose 2 of Rotarix (Month 4)|The analysis was performed on the Rota ATP cohort for analysis of immunogenicity, which included all evaluable subjects who received the two doses of Rotarix vaccine and for whom immunogenicity results were available.|||U/mL||95% Confidence Interval|Geometric Mean
1337106|NCT01978093|Primary|Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL|"Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch."|1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]|The analysis was performed on the Fourth dose According to Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who have received 3 vaccine doses in the first 3-doses vaccination course and who have received the fourth vaccine dose and the first Havrix dose.|||Percentage of subjects||95% Confidence Interval|Number
1337107|NCT01977820|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Death and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 24 weeks + 4-week follow-up|The safety analysis population included all the randomized subjects who received at least one dose of study treatment.|||Subjects|||Number
1337108|NCT01977794|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs was AEs that started or worsened in severity on or after the date of first dose of IMP until the end of the study. AEs leading to death and discontinued were also presented.|Baseline up to Day 127 (end of trial)|Safety analysis set included all subjects who received at least 1 dose of IMP.|||subjects|||Number
1337109|NCT01977794|Secondary|Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment|Baseline was defined as the latest HR before study treatment administration|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
1337110|NCT01977794|Secondary|Percentage of Subjects With Controlled Blood Pressure||Baseline up to Week 18|MITT analysis set included all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP.|||percentage of subjects|||Number
1337111|NCT01977794|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment|Baseline was defined as the latest DBP before study treatment administration.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
1337112|NCT01977794|Primary|Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline|Baseline was defined as the latest SBP under monotherapy.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1337113|NCT01977781|Secondary|Intraocular Pressure|Intraocular pressure is the measure of the fluid pressure within the eye as measured by tonometry. Intraocular pressure is normally measured in millimeters of mercury (mmHg). The normal range for intraocular pressure is 12-20 mmHg, there is no better or worse measurement.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1337114|NCT01977781|Secondary|Visual Acuity|Visual acuity is measured by asking subjects to read letters on a chart that consists of different rows of letters. Each row of letters corresponds to different levels of visual acuity. The Logarithm of the Minimum Angle of Resolution (LogMAR) scale generally ranges from 0 to 1, with 0 corresponding to 20/20 vision and 1 corresponding to 20/200 vision. The range from 0-1 is not absolute, however, as patients who have vision better than 20/20 or vision worse than 20/200 will score out side of the 0 to 1 range.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||LogMAR Scale||Standard Deviation|Mean
1337115|NCT01977781|Secondary|Tear Film Break-Up Time|Tear Film Break-Up Time measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the amount of time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||Seconds||Standard Deviation|Mean
1337116|NCT01977781|Secondary|Schirmer Tear Test (mm)|Schirmer tear test measures the amount of tear secretion produced by a patient in millimeters (mm). Generally, the greater amounts of tear secretion is better than smaller amounts of tear secretion. The minimum value of this scale is 0 mm of tear secretion and there is no maximum value to this scale.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||millimeter (mm)||Standard Deviation|Mean
1337117|NCT01977781|Secondary|Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)|Corneal fluorescein staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The corneal fluorescein staining scale ranges from 0 to 15, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||units on a scale||Standard Deviation|Mean
1337118|NCT01977781|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire|The OSDI questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||units on a scale||Standard Deviation|Mean
1337119|NCT01977781|Primary|Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation|Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability).|10 weeks|The results are taken from the week 10 study assessment|||units on a scale||Standard Deviation|Mean
1337120|NCT01977729|Other Pre-specified|Positive and Negative Affect Scale for Children|Positive and Negative Affect Scale for Children (PANAS-C). Negative affect (NA) will be assessed using the NA subscale on the PANAS-C. The 15 NA items (e.g., sad, miserable) on the 27-item PANAS-C are scored 1 (very slightly or not at all) to 5 (extremely). Higher scores in the NA subscale indicate higher levels of negative affect.|20 weeks from enrollment|No data collected.||||||
1337121|NCT01977729|Secondary|Multidimensional Anxiety Scale for Children|Multidimensional Anxiety Scale for Children (MASC-2; Self-report and Parent completed). Treatment outcome will be assessed on a specific symptom level from the youth's and parent's perspective using the MASC-2. The MASC-2 consists of 50 items across 5 factors: Separation Anxiety/Phobias, Generalized Anxiety Disorder, Social Anxiety, Obsessions & Compulsions, and Harm Avoidance. MASC T-scores less than 65 indicate the child is no longer in the clinical range of anxiety symptoms.|20 weeks from enrollment|Study was terminated before randomization.||||||
1337122|NCT01977729|Primary|Clinical Global Impression Severity & Improvement Scales|Youth outcome will be assessed on a global level using the Clinical Global Impression (CGI) Severity Scale, ranging from 1 (not at all) to 7 (among the most extremely ill patients). Higher ratings indicate greater anxiety symptom severity. The CGI Improvement Scale ranges from 1 (very much improved) to 7 (very much worse). Lower ratings indicate greater improvement on anxiety symptom severity. A CGI Improvement Scale rating of 1 or 2 indicates clinically meaningful improvements in anxiety symptom severity.|20 weeks from enrollment|Medication was never given, and tests were never done.||||||
1337123|NCT01977690|Primary|Average Neck Pain Level|Patients self-recorded their average level of pain on a scale from 1 to 10 for each post-surgery day beginning on postoperative day 2. 1 Meaning least pain, 10 meaning worst level of pain|1 month|4 participants in the Clavicle brace group did not tolerate the brace and are included in the standard management group for this analysis. Only participants will available data are included in the analysis.|||units on a scale (VAS pain scale)||Standard Deviation|Mean
1339167|NCT01954160|Secondary|LV End Systolic Dimension (LVESd)|Echo: LV end systolic dimension (LVESd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1337127|NCT01977625|Primary|Percent Change in Blood Oxygen Level Dependent (BOLD) Signal|Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.|10 weeks|All participants who completed all phases of the study were included in the outcome analysis.|||percent change||Standard Deviation|Mean
1337128|NCT01977612|Secondary|Median Patient Satisfaction Score of Scar Appearance|Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated “very unsatisfied” or 0% and the end of the line was “very satisfied” or 100%.|4-8 weeks post-operative|-Data was not collected on 13 patients in the Stainless Steel Staple arm and 12 patients in the 4-0 Monocryl Suture arm|||Patient Satisfaction Score||Inter-Quartile Range|Median
1337129|NCT01977612|Secondary|Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score|"Ranges from 0 (worst) to 5 (best)~Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0"|4-8 weeks post-operative|-Data was not collected from 10 patients in the Stainless Steel Staple arm and 9 patients in the 4-0 Monocryl Suture arm|||units on a scale||Inter-Quartile Range|Median
1337130|NCT01977612|Secondary|Analog Pain Score on Postoperative Days 3-4|The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.|3-4 days post-surgery|Data was not collected from any patients for this outcome measure||||||
1337131|NCT01977612|Secondary|Operative Time|Time from skin incision to the end of skin closure|During surgery|Data was not collected from 3 patients in the stainless steel staple arm and 1 patient in the 4-0 Monocryl suture arm|||minutes||Inter-Quartile Range|Median
1337132|NCT01977612|Secondary|Incidence of Wound Infection|Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.|4-8 weeks post-surgery||||Participants|||Count of Participants
1337133|NCT01977612|Secondary|Incidence of Wound Disruption||4-8 weeks post-surgery|-Data on incidence of wound disruption was not collected on 9 patients in the stainless steel staple arm and 9 patients in the 4-0 Monocryl suture arm.|||Participants|||Count of Participants
1337134|NCT01977612|Primary|Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.||4-8 weeks post-surgery||||Participants|||Count of Participants
1337135|NCT01977573|Secondary|Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit|Number of Weeks dose was withheld because hemoglobin exceed the upper limit is presented as the number of participants with withheld dose during the time periods categorized by Weeks.|From Week 4 up to Week 24|ITT population.|||participants|||Number
1337136|NCT01977573|Secondary|Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline|Participants receiving additional therapies of blood transfusions, intravenous (IV) iron or rhEPO any time Post Baseline were analyzed. RhEPO was not applicable for the control arms since it was a planned therapy in those arms, hence presented as NA. (EudraCT only: A value of 99999 is used where no data is available or NA.)|From Day 1 up to Week 28|ITT Population|||participants|||Number
1337137|NCT01977573|Secondary|Number of Participants With at Least One Dose Cycle up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.|||participants|||Number
1337138|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. A Hgb cycle is two consecutive Hgb excursions in different directions.|Up to 24 weeks|Completers population.|||participants|||Number
1337139|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks.|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 weeks|Completers population.|||participants|||Number
1337140|NCT01977573|Secondary|Number of Dose Cycles up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease).|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.|||number|||Number
1337141|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Cycles up to 24 Weeks|A Hgb cycle is calculated as two consecutive Hgb excursions in different directions. A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 Weeks|Completers population. Only participants with Hgb cycles were analyzed.|||number of Hgb cycles|||Number
1337142|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Excursions|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. Hgb cycle is calculated as two consecutive Hgb excursions in different directions.|Up to 24 Weeks.|Completers Population: ITT participants who fully completed study without prematurely discontinuing study drug. Only participants with Hgb excursions were analyzed.|||number of excursions|||Number
1337143|NCT01977573|Secondary|Mean Final Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.|||milligrams per day||Standard Deviation|Mean
1337144|NCT01977573|Secondary|Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.|||milligrams||Standard Deviation|Mean
1337145|NCT01977573|Secondary|Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. The number of participants with an adjustment are presented at the timings at which adjustments were done.|From Week 4 up to Week 20|ITT population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.|||Participants|||Number
1337146|NCT01977573|Secondary|Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. Frequency is presented as the number of participants with dose adjustment(s) once, twice, thrice, four times, or five times.|From week 4 up to 24 weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.|||participants|||Number
1337147|NCT01977573|Secondary|Mean Number of Dose Adjustments up to 24 Weeks|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system.|From Week 4 up to 24 Weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.|||number of adjustments||Standard Deviation|Mean
1337148|NCT01977573|Secondary|Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint|Blood samples were collected for individual plasma GSK1278863 and metabolite (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, and GSK2531403) concentration measurement on Day 1 (pre-dose), Wk 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose). Participants available in each arm at the specified time points have been presented.|Day 1 (pre-dose), Week (Wk) 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose)|Pharmacokinetics (PK) population: All participants from whom a PK sample was obtained and analyzed. This population did not include participants from the control groups.|||nanograms per milliliter||Standard Deviation|Mean
1337149|NCT01977573|Secondary|Change From Baseline in Reticulocyte Cell Count at Week 24|Reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline is the last pre-dose red reticulocyte count. Change from Baseline in reticulocyte cell count was calculated by subtracting the Baseline count from the Week 24 count.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||percentage of reticulocytes||Standard Deviation|Mean
1337150|NCT01977573|Secondary|Change From Baseline in Red Blood Cell Count at Week 24|Baseline is the last pre-dose red blood cell count. Change from Baseline in red blood cell count was calculated by subtracting the Baseline count from the post-dose count.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||10^12 cells per liter||Standard Deviation|Mean
1337151|NCT01977573|Secondary|Change From Baseline in Hematocrit at Week 24|Baseline is the last pre-dose hematocrit value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||percentage change in Fraction of 1||Standard Deviation|Mean
1337152|NCT01977573|Secondary|Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24|Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||picogram||Standard Deviation|Mean
1337153|NCT01977573|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24|TIBC measures the blood's capacity to bind iron with transferrin. Baseline is the last pre-dose TIBC value. Change from Baseline in TIBC was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||micromoles per liter||Standard Deviation|Mean
1337154|NCT01977573|Secondary|Change From Baseline in Total Iron at Week 24|Baseline is the last pre-dose total iron value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with available total iron values at Baseline and Week 24 were analyzed.|||micromoles per liter||Standard Deviation|Mean
1337155|NCT01977573|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||percent change||95% Confidence Interval|Geometric Mean
1337156|NCT01977573|Secondary|Change From Baseline in Transferrin Concentration at Week 24|Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||grams per liter||Standard Deviation|Mean
1337157|NCT01977573|Secondary|Change From Baseline in Ferritin Concentration at Week 24|Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||micrograms per liter||Standard Deviation|Mean
1339168|NCT01954160|Secondary|Global Longitudinal Strain|Echo: Global longitudinal strain Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1337158|NCT01977573|Secondary|Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24|The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Weeks 12 to 24|ITT population. Only participants with data available at specific time points were analyzed.|||percentage of days||Standard Deviation|Mean
1337159|NCT01977573|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-baseline values minus the Baseline value.|Baseline and up to Week 24|ITT population. Only participants with data available at Baseline and a maximum observed change were analyzed.|||percent change in VEGF concentration||95% Confidence Interval|Geometric Mean
1337160|NCT01977573|Secondary|Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)|Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baseline values minus the Baseline value.|Baseline to Week 24|ITT population. Only participants having a Baseline EPO measurement and at least one post-baseline EPO measurement were analyzed.|||International Units per liter||Standard Deviation|Mean
1337161|NCT01977573|Secondary|Percent Change From Baseline in Hepcidin Concentration at Week 24|Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|Intent-to-Treat (ITT) population consisted all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants with available hepcidin values at Baseline and Week 24 were analyzed.|||percent change in Hepcidin||95% Confidence Interval|Geometric Mean
1337162|NCT01977573|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The Hgb stopping criteria was a value of <7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure.|Over a period of 24 Weeks|ITT population.|||Participants|||Number
1337163|NCT01977573|Secondary|Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24|Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Week 24|ITT population. Only participants who were available at the indicated time point were analyzed.|||participants|||Number
1337164|NCT01977573|Primary|Summary of Hemoglobin (Hgb) Concentration at Week 24|"The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original criteria (Original) and those following the amended (Amended) criteria. The primary objective was to characterize the ability of GSK1278863 to achieve mean Hgb response within the target range."|Week 24|Intent-to-Treat (ITT): The ITT population consisted of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants who were available at the indicated time point were analyzed.|||grams per deciliter||Standard Deviation|Mean
1337165|NCT01977482|Secondary|Change From Baseline in Reticulocyte Count at Week 24|A reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline value for reticulocyte count is the pre-dose value on Day 1. Change from Baseline in reticulocyte count was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Percentage of reticulocytes in blood||Standard Deviation|Mean
1337166|NCT01977482|Secondary|Change From Baseline in Red Blood Cells at Week 24|Baseline value for red blood cells is the pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||10^12 cells/Liter||Standard Deviation|Mean
1337167|NCT01977482|Secondary|Change From Baseline in Hematocrit at Week 24|Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Ratio||Standard Deviation|Mean
1337168|NCT01977482|Secondary|Change From Baseline in Reticulocyte Hemoglobin at Week 24|Baseline value for reticulocyte hemoglobin is the pre-dose value on Day 1. Change from Baseline in reticulocyte hemoglobin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Picogram||Standard Deviation|Mean
1337169|NCT01977482|Secondary|Change From Baseline in Total Iron Binding Capacity at Week 24|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Micromoles/Liter||Standard Deviation|Mean
1337170|NCT01977482|Secondary|Change From Baseline in Total Iron at Week 24|Baseline value for total iron is the pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Micromoles/Liter||Standard Deviation|Mean
1337171|NCT01977482|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline =: 100*(exp(Mean change log scale)-1).|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
1337172|NCT01977482|Secondary|Change From Baseline in Transferrin at Week 24|Baseline value for transferrin is the pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||grams (g)/Liter (L)||Standard Deviation|Mean
1337173|NCT01977482|Secondary|Change From Baseline in Ferritin at Week 24|Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Micrograms/Liter||Standard Deviation|Mean
1337174|NCT01977482|Secondary|Percent Change From Baseline in Hepcidin at Week 24|Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
1337175|NCT01977482|Secondary|Population Plasma PK Parameters of GSK1278863 and Metabolites|Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose [PrD), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour [hr] post-dose [PoD), and at W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.|Day 1, Week 4, and Week 20|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the pharmacokinetic population|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1337176|NCT01977482|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline (Day 1) to Week 28|ITT Population. Only participants with data available at specific time point were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
1337177|NCT01977482|Secondary|Maximum Observed Change From Baseline in Erythropoietin (EPO)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-dose values minus the Baseline value.|Baseline (Day 1) to Week 28|ITT Population. Only participants with data available at specific time point were analyzed.|||international units(IU)/Liter (L)||Standard Deviation|Mean
1337178|NCT01977482|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The number of participants who reached the Hgb stopping criteria of Hgb concentration <7.5 g/dL were presented.|Up to 24 weeks|ITT Population|||Participants|||Number
1337179|NCT01977482|Secondary|Number of Participants With Hgb in the Target Range at Week 24|The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Participants|||Number
1337180|NCT01977482|Secondary|Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24|The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated.|Week 20 to Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||Percentage of days||Standard Deviation|Mean
1337181|NCT01977482|Secondary|Hgb Concentration at Week 24|Hgb values measured at Week 24 are presented.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||g/dL||Standard Deviation|Mean
1337182|NCT01977482|Primary|Change From Baseline in Hemoglobin (Hgb) at Week 4|Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Alpha is the coefficient of the model covariate for centred Baseline.|Baseline (Week -4, Week-2 and Day 1) and Week 4|ITT Population. Only participants with data available at specific time point were analyzed.|||grams (g)/deciliter (dL)||Standard Deviation|Mean
1337183|NCT01977456|Other Pre-specified|The Number of Participants With Good Outcomes According to the Modified Rankin Score.|Modified Rankin score (mRS) dichotomized to good outcome (mRS 0-1 or return to baseline), poor outcome (all others including death). Results reported are good outcome.|90 days from the date of stroke onset||||participants|||Number
1337184|NCT01977456|Secondary|The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2).|Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT|within 36 hours after stroke onset||||participants|||Number
1337185|NCT01977456|Secondary|The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH).|Any ICH symptomatic (as defined above) or asymptomatic (that visualized on CT or MRI only)|within 36 hours after stroke onset||||participants|||Number
1337186|NCT01977456|Primary|The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH).|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|within 36 hours after stroke onset||||participants|||Number
1337187|NCT01977352|Secondary|Sleep Quality|scale of 0-10, 0=horrible, up all night; 10=perfect sleep|Post op Day 1, post op Day 2, post op day 3, post op 1 week||||units on a scale||Standard Deviation|Mean
1337188|NCT01977352|Secondary|Incidence of Postoperative Nausea and Vomiting||72 hours||||percentage of participants|||Number
1337189|NCT01977352|Secondary|Time to Discharge Home|data not collected|72 hours|||||||
1337190|NCT01977352|Secondary|Time to First Pain Medicine||72 hours||||minutes||Standard Deviation|Mean
1337191|NCT01977352|Secondary|Sensory and Motor Block|Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function.|at 20 min and at 1 hour||||units on a scale||Standard Deviation|Mean
1337192|NCT01977352|Secondary|Quality of Analgesia|The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain.|Post op Day 1, post op Day 2, post op day 3, post op 1 week||||units on a scale||Standard Deviation|Mean
1337193|NCT01977352|Primary|Total Opioid Consumption|Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.|Post op Day 1, post op Day 2, post op day 3, post op 1 week||||number of percocet tabs||Standard Deviation|Mean
1337194|NCT01977222|Other Pre-specified|Change in VE/VCO2 Slope (Ratio) During Exercise||Baseline and after 12 weeks of training||||ratio||Standard Deviation|Mean
1337195|NCT01977222|Other Pre-specified|Change in Peak Work Rate During Exercise||Baseline and after 12 weeks of training||||Watts||Standard Deviation|Mean
1337196|NCT01977222|Other Pre-specified|Change in Oxygen Pulse at Peak Exercise||12 weeks||||mL/beat||Standard Deviation|Mean
1337197|NCT01977222|Other Pre-specified|Change in Maximal Inspiratory Pressure||Baseline and after 12 weeks of training||||cmH2O||Standard Deviation|Mean
1337198|NCT01977222|Other Pre-specified|Change in Maximum Voluntary Ventilation||12 weeks||||L/min||Standard Deviation|Mean
1337199|NCT01977222|Secondary|Change in SF-36 Health Survey Score (Physical Component Summary)|The 36-Item Short Form (SF-36) Health Survey is a disease-generic survey of an individual’s perceived health status and health-related quality of life. There are eight scaled scores, which are the weighted sums of the questions in their section. Each scale is transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. These eight scales are then used to calculate (using a proprietary formula) two summary scores: the physical component score (PCS), representing the four physical health scales (physical functioning, role physical, bodily pain, general health), and the mental component score (MCS), representing the four mental health scales (mental health, role emotional, vitality, social functioning). Component scores are norm-based with a mean of 50 (standardized to the US population) and a standard deviation of 10.|12 weeks||||units on a scale||Standard Deviation|Mean
1337200|NCT01977222|Secondary|Change in Innocor Measurement (Inert Gas Rebreathing Method) of Cardiac Output at Peak Exercise||12 weeks|One individual failed to sustain maximal exercise long enough to complete measurement of cardiac output on her post-intervention study. That individual was therefore left out of the data analysis for cardiac output at peak exercise ONLY.|||L/min||Standard Deviation|Mean
1337201|NCT01977222|Primary|Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements.||Baseline and after 12 weeks of training||||ml/kg/min||Standard Deviation|Mean
1337202|NCT01977092|Primary|Change in Worries About HIV in Past 6 Months.|Measured by whether or not the participant was worried about HIV in past 6 months.|Baseline, 6 months, and 12 months|330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.|||Participants|||Count of Participants
1337203|NCT01977092|Primary|Change in Alcohol and Drug Use (Timeline Follow Back)|Measured by whether or not the participant reports complete abstinence from all substance use for last 6 months on Timeline Followback (TLFB).|Baseline, 6 months, and 12 months|330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews.|||Participants|||Count of Participants
1337204|NCT01977092|Primary|Change in Criminal Justice Outcomes|Measured by dichotomous measure of whether or not any time spent incarcerated in past 6 months.56 follow-up interviews were conducted in jails, when allowed and the participant was comfortable, but we did not conduct interviews in prison. See participant flow for number of participants in prison.|Baseline, 6 months, and 12 months|330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.|||Participants|||Count of Participants
1337205|NCT01976988|Secondary|Number of Participants With VTE Within 30-day After Surgery|any VTE occuring within 30-days after surgery - clinical or asymptomatic - detected by venous duplex ultrasound, vq scan or ct pulmonary angiogram.|30 day postop period||||participants|||Number
1337206|NCT01976988|Secondary|Hospital Stay|Length of postoperative hospital stay|30 day postop period||||days||Inter-Quartile Range|Median
1337207|NCT01976988|Secondary|Number of Participants With Surgical Complications|Major or minor medical and surgical complications|30 day postop period||||participants|||Number
1337208|NCT01976988|Secondary|Number of Participants With Postoperative Thrombocytopenia|Thrombocytopenia defined as >50% or greater drop in platelet count|30 day postop period||||participants|||Number
1337209|NCT01976988|Secondary|Number of Participants With Bleeding Complications|"Major bleeding defined as any intracranial or intraocular hemorrhage or bleeding from any site associated with >2g/dL drop in hemoglobin or transfusion of >2 unit packed RBCs (including operative site bleeding, unexpected upper or lower gastrointestinal hemorrhage, or retroperitoneal hemorrhage) or any hemorrhage needing surgical intervention/reoperation or leading to death.~Minor bleeding defined as wound hematoma, ecchymosis >10 cm, epistaxis of more than 2 minute duration, macroscopic hematuria, unexpected upper or lower GI hemorrhage associated with <2g/dL drop in hemoglobin or <2 unit packed RBC transfusion"|30 day postop period||||participants|||Number
1337210|NCT01976988|Primary|Number of Participants With Postoperative VTE Within 48 Hours After Surgery|Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period|48 hour postop period||||participants|||Number
1337211|NCT01976871|Secondary|The Clinician Global Impression of Change Scale|The Clinician Global Impression of Change scale (CGIC) will be used to assess patient satisfaction with treatment.|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||participants|||Number
1337212|NCT01976871|Secondary|The Patient Global Impression of Change Scale|"The Patient Global Impression of Change scale (PGIC) will be used to assess patient satisfaction with treatment.~The PGIC assesses subjective changes in symptoms during clinical trials. This single-item scale asks participants to rate their symptoms as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.” The measure provides a responsive and easily interpretable assessment of participants’ evaluations of the importance of their improvement or worsening."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||participants|||Number
1337213|NCT01976871|Secondary|Preference of Medication Scale (POM)|"The POM will be used to assess patient satisfaction with treatment.~The POM scale is designed to summarize subjects’ preference for the study medication compared to prior therapy. It asks a single question: How does this current medicine compare to the previous RLS medicine(s) you were taking? The response set is as follows: (1) Much Better, I prefer this medication (indicating preference for rotigotine); (2) Slightly Better; (3) About the Same; (4) Slightly Worse; (5) Much Worse, I much prefer my previous medication (indicating preference for oral dopamine agonist)."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||participants|||Number
1337214|NCT01976871|Secondary|RLS-6 Scale|"The RLS-6 scale will be used to determine the overall efficacy of RLS symptom control on rotigotine, calculated as a mean score for each scale during the final treatment week vs baseline.~The RLS-6 scale are 11-point (0=not present to 10=very severe) metrics for measuring RLS severity. Four questions delineate a severity profile of RLS during different night and daytime periods: at bedtime, during the night, during the day at rest, during daily activities. The final two questions assess satisfaction with sleep and severity of sleepiness during the day. The RLS-6 scales have been validated on a day-to-day basis, with relatively low placebo effect compared to other RLS rating scales.~Minimum score 0, maximum score 60. A decrease in the RLS-6 score indicates a better outcome. The RLS-6 scale was completed each day of the study and averaged for the baseline week (approximately days 1-7 of the study) and the final week (approximately days 21-28 of the maintenance period)."|Average of Baseline titration week (approximately days 1-7 of the study) vs. Average of Final Treatment week (integrating data from days 28-35 after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||units on a scale||Standard Deviation|Mean
1337215|NCT01976871|Secondary|International Restless Legs Scale (IRLS)|"The IRLS will be used to determine the overall efficacy of RLS symptom control on rotigotine.~The IRLS is a well-validated instrument for measuring RLS severity during the past week. It includes 10 questions encompassing intensity and frequency of symptoms, associated sleep problems, and the impact of symptoms on the patients’ mood and daily functioning. This scale has been shown to have high internal consistency, inter-examiner reliability, test-retest reliability, and convergent validity.~Minimum score 0, maximum score 40. A decrease in the IRLS score indicates a better outcome."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||units on a scale||Standard Deviation|Mean
1338098|NCT01966770|Primary|Overall Ease of Lens Handling (Day 2 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy|Day 2 - After Removal||||units on a scale||Standard Deviation|Mean
1337216|NCT01976871|Primary|Proportion of Patients Completing the Switch and Their Adverse Events|"The primary endpoint will be the safety and tolerability of switching from an oral dopamine agonist to rotigotine.~The CGIC scales were developed to assess treatment outcomes in pharmacological studies. The scales are meant completed by the clinician in person after assessment of the subject. They include 4 global scales describing the severity of illness, change in severity from baseline, therapeutic efficacy, and tolerability of treatment.~Clinical Global Impression - Improvement scale (CGI-I) rated as: 1, very much improved since the baseline week; 2, much improved; 3, minimally improved; 4, no change from baseline; 5, minimally worse; 6, much worse; or 7, very much worse since the baseline week. The CGI-I was performed at baseline and at Week 5 to see which participants rated as much or very much improved.~Adverse Events are reported in the Adverse Events module."|Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits||||participants|||Number
1337217|NCT01976845|Secondary|Produces Amnesia(Memory Recall)|"Ability to recall (memory of):~•recall of 2 pictures"|one day|Subjects who recall the picture|||participants|||Number
1337218|NCT01976845|Secondary|Scores on the Verbal Rating Scale For Sleepiness (Sedation)|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely sleepiness)|one day||||Scores on a Scale (0-10)||Standard Deviation|Mean
1337219|NCT01976845|Primary|Scores on the Verbal Rating Scale For Anxiety|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely nervous)|one day||||Scores on a Scale (0-10)||Standard Deviation|Mean
1337220|NCT01976819|Primary|Device Preference Rating.|"Patients were asked to rate the devices on a scale from 0-10, where 10 indicates the best score and 0 the worst score. The overall mean satisfaction with the speaking valve was rated."|Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)||||units on a scale||Standard Deviation|Mean
1337221|NCT01976819|Primary|Hours of HME Use Per Day.|The mean number of hours of TW use per 24 hours was calculated.|Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)||||hours per day||Standard Deviation|Mean
1337222|NCT01976819|Primary|Evaluate Patient Experiences Associated With Exposure to the Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients Based on Results From Questionnaires.|"Patients were asked to use either the old TW15 and the TW22 HME device for a week, data combined for the two devices (the device used was recorded). After each week, patients completed a device specific questionnaire (Borg Scale).~After the re-design (ie Updated speaking valve), patients were asked to use the new Speaking Valve for a week and then to complete relevant sections of the same questionnaire. Both at baseline and in the follow-up, patients were asked about their breathing using a Borg scale at a particular moment. This scale has a range from 0-6 where a score close to 0 indicates less breathing problems."|3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).||||units on a scale||Standard Deviation|Mean
1337223|NCT01976806|Other Pre-specified|Change in Red Blood Cell Membrane Docosahexaenoic Acid|Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.|Baseline and 3 months||||% of total RBC FA||Standard Error|Mean
1337224|NCT01976806|Secondary|Urine N-Terminal Telopeptides|Urine N-Terminal Telopeptides are a measure of systemic bone turnover.|Baseline and 3 months||||nM BCE||Standard Error|Mean
1337225|NCT01976806|Secondary|Serum Soluble Vascular Cell Adhesion Molecule|Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.|Baseline and 3 months||||ng/mL||Standard Error|Mean
1337226|NCT01976806|Secondary|Serum High-sensitivity Interleukin-6|Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.|Baseline and 3 months||||pg/mL||Standard Error|Mean
1337227|NCT01976806|Secondary|Serum High-sensitivity C-reactive Protein|Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.|Baseline and 3 months||||mg/L||Standard Error|Mean
1337228|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-1 Beta|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.|Baseline and 3 months|Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.|||pg/mL||Standard Error|Mean
1337229|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-6|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.|Baseline and 3 months|Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.|||pg/mL||Standard Error|Mean
1337230|NCT01976806|Secondary|Gingival Crevicular Fluid High Sensitivity C-reactive Protein|Gingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.|Baseline and 3 months|Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.|||ng/mL||Standard Error|Mean
1337231|NCT01976806|Secondary|Sites With Bleeding on Probing (Yes/no)|Bleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.|3 months|Results presented at 3 months; 3-months results also compared to baseline BOP using logistic regression as described in manuscript.|||Sites|Sites||Count of Units
1337232|NCT01976806|Secondary|Change in Plaque Index (0-3)|"Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line.~Score Criteria:~0: No plaque~A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe.~Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.~Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|Baseline and 3 months||||Plaque index units||Standard Error|Mean
1337233|NCT01976806|Secondary|Change in Gingival Index (0-3)|"Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3).~Score Criteria:~0: No inflammation.~Mild inflammation, slight change in color, slight edema, no bleeding on probing.~Moderate inflammation, moderate glazing, redness, bleeding on probing.~Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding."|Baseline and 3 months||||GI units||Standard Error|Mean
1339169|NCT01954160|Secondary|Left Ventricular Ejection Fraction|Echo: Left Ventricular Ejection Fraction Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1337235|NCT01976663|Secondary|Mean Improvement in Overall Nasolabial Folds FACE-Q Score|Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Improvement is defined as the score at Month 12 minus the baseline score.|Baseline, Month 12|modified intent-to-treat (mITT): all randomized and treated subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1337236|NCT01976663|Secondary|Percentage of Nasolabial Folds With ≥1-Point Improvement|Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.|Baseline, Month 12|modified intent-to-treat (mITT): all randomized and treated subjects|||Percentage of Nasolabial Folds||95% Confidence Interval|Number
1337237|NCT01976663|Primary|Percentage of Nasolabial Folds With ≥1-Point Improvement|Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.|Baseline, Month 6|modified intent-to-treat (mITT): all randomized and treated subjects|||Percentage of Nasolabial Folds||95% Confidence Interval|Number
1337238|NCT01976663|Primary|Mean Improvement (Reduction) in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)|Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). Mean reduction from baseline in NFLSS is defined as score at baseline minus score at Month 6. The mean reduction indicated improvement (decrease) in nasolabial fold severity.|Baseline, Month 6|modified intent-to-treat (mITT): all randomized and treated subjects|||Scores on a Scale||Standard Deviation|Mean
1337239|NCT01976650|Secondary|Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved and was considered 'effective'. The percentage of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|4 Years|Efficacy Population: all patients who were treated per protocol who had data available for analysis|||Percentage of Participants|||Number
1337240|NCT01976650|Primary|Number of Patients With Adverse Events or Adverse Drug Reactions|An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|4 Years|Safety Population: all patients who were treated per protocol and completed a survey|||Patients|||Number
1337241|NCT01976624|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.|Baseline, Week 4|Efficacy population included all participants who were treated for on-label indications with data available for analysis.|||mmHg||Standard Deviation|Mean
1337242|NCT01976624|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|Up to 51 months|Safety population included all participants treated for on-label indications.|||participants|||Number
1337243|NCT01976572|Secondary|T1/2|Apparent plasma terminal elimination half-life|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose||||hr||Standard Deviation|Mean
1337244|NCT01976572|Secondary|Tmax|Time of maximum observed plasma concentration|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose||||hr||Full Range|Median
1337245|NCT01976572|Primary|Cmax of Candesartan|Maximum observed plasma concentration|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.|||ng/mL||Standard Deviation|Mean
1337246|NCT01976572|Primary|AUC0-t of Candesartan|Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.|||ng*hr/mL||Standard Deviation|Mean
1337247|NCT01976507|Secondary|Number of Participants With Minor Bleeding Events||Within 4 months following procedure (+/- 4 days)||||Participants|||Count of Participants
1337248|NCT01976507|Secondary|Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event.||Within 4 months following procedure (+/- 4 days)|This measure was removed from the protocol. No blood draws were done on any participants.||||||
1337249|NCT01976507|Primary|Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.||Within 4 months following procedure (+/- 4 days)||||number of events|||Number
1337250|NCT01976507|Primary|Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.||Within 4 months following procedure (+/- 4 days)||||number of events|||Number
1337251|NCT01976442|Primary|Survial Rate at 5 Years|The percentage of patients who were alive at 5 years after transfusion.|5 years||||percentage of participants|||Number
1337252|NCT01976442|Primary|Survial Rate at 100 Days|The percentage of patients who were alive at 100 days after transfusion.|100 days||||percentage of participants|||Number
1337253|NCT01976442|Primary|Survial Rate at 60 Days|The percentage of patients who were alive at 60 days after transfusion.|60 days||||percentage of participants|||Number
1337254|NCT01976442|Primary|Survial Rate at 30 Days|The percentage of patients who were alive at 30 days after transfusion.|30 days||||percentage of participants|||Number
1337255|NCT01976338|Secondary|Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12|The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.|Baseline, months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n=the number of patients with a value for both baseline and the specific post-baseline visit.|||Scores on a Scale||Standard Deviation|Mean
1337256|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|Months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||mm^2||Standard Deviation|Mean
1337257|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|Months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||mm^2||Standard Deviation|Mean
1337258|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|month 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||mm^2||Standard Deviation|Mean
1337259|NCT01976338|Secondary|Change in Central-Sub-Field- Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||µm||Standard Deviation|Mean
1337260|NCT01976338|Secondary|Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Baseline to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Participants|||Number
1337261|NCT01976338|Secondary|Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters|Baseline to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Participants|||Number
1337262|NCT01976338|Secondary|Best Corrected Visual Acuity (BCVA) Change Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Month 1 through Month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Letters||Standard Deviation|Mean
1337263|NCT01976338|Secondary|Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Baseline to Month 1 through Month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Letters||Standard Deviation|Mean
1337264|NCT01976338|Primary|Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.|Baseline to Month 1 through Month 6|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Letters||Standard Deviation|Mean
1337265|NCT01976312|Secondary|The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline|The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.|Month 3,6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n= is the number of patients with a value for both baseline and the specific post-baseline visit.|||Scores on a scale||Standard Deviation|Mean
1337266|NCT01976312|Secondary|Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Month 1 to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Participants|||Number
1337267|NCT01976312|Secondary|Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Participants|||Number
1337268|NCT01976312|Secondary|Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||microns||Standard Deviation|Mean
1337269|NCT01976312|Secondary|Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline|Month 1 to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
1337270|NCT01976312|Secondary|Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Baseline, 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
1337271|NCT01976312|Primary|Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3|"Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.~Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline."|Baseline, 3 Months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
1337272|NCT01976299|Secondary|Secondary Endpoint 3- Change in Kidney Function.|Change in kidney function by analyzing eGFR 3 to 5 days post procedure.|3-5 days||||mL/min/1.73m²||Standard Deviation|Mean
1337273|NCT01976299|Secondary|Secondary Endpoint 2- Comparison of Serious Adverse Events.|Comparing event rates of serious adverse events 30 days following the index procedure.|30 Days||||events|||Number
1337274|NCT01976299|Secondary|Secondary Endpoint 1-|Comparison in contrast media volume required between active treament and standard of care.|30 Days|Reduction in volume of contrast was analysed in an interim analysis once half the patient population was enrolled. Additionally, only subjects that completed the procedure were analyzed for this endpoint.|||Contrast Volume (ml)||Standard Deviation|Mean
1337275|NCT01976299|Primary|Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event|Analyze the incidence of device related serious adverse events within the treatment arm.|30 days||||Participants|||Count of Participants
1337276|NCT01976299|Primary|Primary Effectiveness Endpoint|Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.|3-5 days|Only subjects that completed blood draws were analyzed for this outcome.|||Participants|||Count of Participants
1337522|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment||Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of overall work impairment||Standard Deviation|Mean
1337277|NCT01976273|Primary|Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10|The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.|Week 10||||units on a scale||Standard Deviation|Mean
1337278|NCT01976104|Other Pre-specified|Number of Participants Experiencing an Adverse Event|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Treatment-emergent adverse events (TEAEs) were defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.|From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months|Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. One participant in the High Baseline Platelet Count Cohort received 60 mg avatrombopag and hence was included in the <40×10^9/L Low Baseline Platelet Count Cohort in all safety analyses.|||Participants|||Count of Participants
1337279|NCT01976104|Other Pre-specified|Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After Randomization and up to 7 Days After an Scheduled Procedure|The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss requires transfusion (severe), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.|Baseline (Visit 2) up to 7 days post scheduled procedure|FAS|||Percentage of participants|||Number
1337280|NCT01976104|Secondary|Change From Baseline in Platelet Counts on Scheduled Procedure Day|Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.|Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)|FAS. Only those participants with data available at both Baseline and post-Baseline were analyzed.|||platelet count x 10^9 per liter||Standard Deviation|Mean
1337281|NCT01976104|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day|Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10^9/L on the procedure day. Participants missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10^9/L in the analysis, (i.e. Non-responders).|Day 10 to Day 13 (Visit 4)|FAS|||Percentage of participants||95% Confidence Interval|Number
1337282|NCT01976104|Primary|Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure|Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).|Randomization (Visit 2), up to 7 Days following a scheduled procedure|Full analysis Set (FAS) was defined as the group of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1337283|NCT01975974|Primary|Successful First Attempt Peripheral Venous Cannulation|we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.|one day||||participants|||Number
1337284|NCT01975948|Other Pre-specified|Between Group Change in Sheehan Disability Scale (SDS)|The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SDS ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
1337285|NCT01975948|Other Pre-specified|Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months|We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.|6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||Participants|||Count of Participants
1337307|NCT01975675|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1337286|NCT01975948|Other Pre-specified|Between Groups Changes in Quality of Life From Baseline to 6 Months.|The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SF-36 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3 and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
1337287|NCT01975948|Other Pre-specified|Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months|The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal CSI ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2,3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
1337288|NCT01975948|Other Pre-specified|Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills|A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre–Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from ‘very confident’ to ‘not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach’s alpha was .98 at pre-test and .98 at post-test|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1337289|NCT01975948|Other Pre-specified|Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills|"A modified version of a British Columbia (BC) developed survey Practice Support Program Pre–Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from ‘very confident’ to ‘not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach’s alpha for physicia was .90 at pre-test and .91 at post-test,~3"|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1337290|NCT01975948|Other Pre-specified|Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness|"A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre–Post Learning Module Questionnaire was used. Physician confidence was measured on a three point scale ranging from ‘very confident’ to ‘not at all confident.’ Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to:~diagnose depression~screen for addictions~screen for other mental health conditions~treat depression~treat other mental health disorders~prescribe medications for mental health conditions~assess patients’ problems and strengths~overall confidence in quality of mental health care provided~knowledge/awareness of non-pharmaceutical interventions~knowledge/awareness of regional mental health resources for patients~Cronbach’s alpha .84 at pre-test and .87 at post-test"|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1337291|NCT01975948|Secondary|Economic Impact|Health care costs in the two groups will be estimated using data gathered from the self report Client Service Receipt Inventory questionnaire, additional information will be obtained from Health Data Nova Scotia (HDND) registry. Administrative data will be collected from six of the HDNS registries: (1) Medical Services Insurance (MSI) Physician Billings, (2) Canadian Institute for Health Information (CIHI) Hospital Discharge Abstract Database, (3) Pharmacare Prescriptions, (4) Insured Patient Registry, (5) Patient Geography, (6) Licensed Provider Registry|January 1st, 2013 - September 31st, 2015 or end of available data||2020-12-31|12/2020||||
1337292|NCT01975948|Secondary|Between Group Changes in Occupational Functioning From Baseline to 6 Months|Lam’s Employment Absence and Productivity Scale (LEAPS) is a 7 item scale that assesses workplace impact of major depression. Each item is rated on a 5-point Likert scale with the following response format: none of the time (0%), some of the time (25%), half the time (50%), most of the time (75%), or all the time (100%), scored as 0-4, respectively. Total scores can range from 0-28 with lower scores indicating less disruption.We compared between-group mean differences of LEAPs scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal LEAPs ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
1337308|NCT01975675|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1337293|NCT01975948|Primary|Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)|The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures three main dimensions of stigma; negative attitudes, health professionals’ own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.|Baseline and at 6 months||||units on a scale||Standard Deviation|Mean
1337294|NCT01975948|Primary|Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline|The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
1337295|NCT01975935|Secondary|Change in Weight|Change in weight (kilograms) as measured at baseline and week 12 visits.|12 week|The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.|||kilograms||Standard Deviation|Mean
1337296|NCT01975935|Secondary|Hepatic Steatosis as Measured by MRI|Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit.|12 weeks|One placebo patient was an early termination and did not have an MRI scan done at the 12 week visit. A total of 20 patients received MRI scans due to funding limitations.|||% fat||Standard Deviation|Mean
1337297|NCT01975935|Primary|Difference in Hemoglobin A1c Values|Difference in hemoglobin A1c as measured at baseline and week 12 visits|12 weeks (measured at baseline and 12 weeks)|The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.|||percentage of hemoglobin glycated||Standard Deviation|Mean
1337298|NCT01975922|Secondary|Expressive Vocabulary at 4 Months After Baseline|Number of different words the child says during a 20-minute language sample.|4 months||||Number of Different words||Standard Deviation|Mean
1337299|NCT01975922|Primary|Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition|"Pre-school Language Scale - 4th Edition (a norm-referenced measure of receptive and expressive language) This scale measures the child's expressive and receptive language by going through a standard protocol of items, beginning based on the child's age, requiring a Basal of 3 consecutive correct responses and a Ceiling of 6 consecutive incorrect responses.~A higher score is considered better. A standard score of 100 is considered average for the child's age with scores ranging from 50-150."|4 months||||units on a scale||Standard Deviation|Mean
1337300|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Mobility and Turning|"Mobility and turning is assessed by the timed up-and-go test (Podsiadlo & Richardson, 1991). The participant will be seated in an armed chair. On the word go, the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible."|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
1337301|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Standing Postural Control|Postural control - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 30second trials of standing with eyes open on a stationary force platform (AMTI, Watertown, MA).|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
1337302|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Gait Speed in 90 Second Walking Test|Two 90 second trials of walking at a preferred speed along a 80x4m indoor hallway. A wireless Noraxon DTS system (Noraxon Inc, Scottsdale, AZ) will be used simultaneously and continuously record bilateral foot placements, 3-dimensional trunk accelerations, and lower-extremity surface electromyography of eight muscles.|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
1337303|NCT01975909|Secondary|Percent Change From Baseline to Post Treatment on the 9-hole Peg Test|The test consists of a block with nine holes, into which the subject places and then removes 9 pegs. The time taken to complete the test will be recorded.|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
1337304|NCT01975909|Secondary|Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk|A quantitative assessment of mobility and leg function. Two trials of patients walking along a 25ft course as quickly and safely as possible. Time taken to complete course will be recorded and averaged across trials.|Baseline and 1 week post treatment||||percentage change of maximum gait speed||Standard Deviation|Mean
1337305|NCT01975909|Primary|Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)|Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance.|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
1337306|NCT01975675|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
1337310|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Treatment-naive participants in the Full Analysis Set (randomized, received at least 1 dose of study drug, and had chronic genotype 1 (1a, 1b, or mixed 1a/1b) HCV infection) without cirrhosis were analyzed.|||percentage of participants|||Number
1337311|NCT01975467|Secondary|Range of Motion and Strength|The ASES instrument will be used to assess range of motion and strength.|One time point|||||||
1337312|NCT01975467|Primary|DASH Score|Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.|One time point|Terminated due to low enrollment||||||
1337313|NCT01975389|Secondary|Percent Change From Baseline in Log-transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Deviation|Mean
1337314|NCT01975389|Secondary|Percent Change From Baseline in Log-transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14||Baseline, Week 14|"FAS population. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent change||Standard Deviation|Mean
1337315|NCT01975389|Secondary|Percent Change From Baseline in Lipid Levels at Week 14|Lipids included non-high density lipoprotein cholesterol (non-HDL-C), very low density lipoprotein cholesterol (VLDL-C), remnant lipoprotein cholesterol (RLP-C), apolipoprotein B (Apo B), HDL-C, apolipoprotein A-I (Apo A-I) and total cholesterol.|Baseline, Week 14|"FAS population. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent change||Standard Error|Least Squares Mean
1337316|NCT01975389|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement||Baseline, last post-baseline measurement (any time up to Week 140)|"Analysis was performed on FAS. Here, N signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Error|Least Squares Mean
1337317|NCT01975389|Secondary|Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies those participants who were evaluable for this outcome measure."|||mg/dL||Standard Error|Least Squares Mean
1337318|NCT01975389|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Error|Least Squares Mean
1337319|NCT01975389|Secondary|Event Rate Per 100 Participant-years for All-cause Death|Event rate per 100 participant-years for occurrence of all-cause death (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337320|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Arterial Revascularizations|Event rate per 100 participant-years for first occurrence of any arterial revascularizations (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337321|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Percutaneous Coronary Intervention (PCI)|Event rate per 100 participant-years for first occurrence of PCI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337322|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)|Event rate per 100 participant-years for first occurrence of CABG (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337323|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Coronary Revascularization|Event rate per 100 participant-years for first occurrence of coronary revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337324|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)|Event rate per 100 participant-years for first occurrence of hospitalization for CHF (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337325|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337326|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Stroke|Event rate per 100 participant-years for first occurrence of non-fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337327|NCT01975389|Secondary|Event Rate Per 100 Participant-years for Fatal Stroke|Event rate per 100 participant-years for occurrence of fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337328|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal), of Any Etiology|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) of any etiology (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337329|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal)|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337330|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Myocardial Infarction (MI)|Event rate per 100 participant-years for first occurrence of non-fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337331|NCT01975389|Secondary|Event Rate Per 100 Participant-years for Fatal Myocardial Infarction (MI)|Event rate per 100 participant-years for occurrence of fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337349|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)|Event rate per 100 participant-years for first occurrence of CABG (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337332|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Myocardial Infarction (Fatal or Non-fatal)|Event rate per 100 participant-years for first occurrence of any myocardial infarction (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any myocardial infarction (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337333|NCT01975389|Secondary|Event Rate Per 100 Participant-years for Cardiovascular (CV) Death|Event rate per 100 participant-years for occurrence of CV death (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337334|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337335|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337336|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337337|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infraction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337350|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Coronary Revascularization|Event rate per 100 participant-years for first occurrence of coronary revascularization (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1339170|NCT01954160|Secondary|Left Ventricular End Systolic Volume|Echo: Left ventricular end systolic volume Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1337338|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of CV Death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337339|NCT01975389|Primary|Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event|Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death [defined as sudden cardiac death, fatal myocardial infarction (MI), death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes] non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
1337340|NCT01975376|Secondary|Percent Change From Baseline in Log-Transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies number of participants who were evaluable for this outcome measure."|||Percent change||Standard Deviation|Mean
1337341|NCT01975376|Secondary|Percent Change From Baseline in Log-Transformed Lipoprotein (a) (Lp[a]) and Triglycerides at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent Change||Standard Deviation|Mean
1337342|NCT01975376|Secondary|Percent Change From Baseline in Lipid Levels at Week 14|Lipids included non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol, very low density lipoprotein cholesterol (VLDL-C), remnant lipoprotein cholesterol (RLP-C), apolipoprotein B (Apo B), HDL-C and apolipoprotein A-I (Apo A-I).|Baseline, Week 14|"Analysis was performed on FAS. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent Change||Standard Error|Least Squares Mean
1337343|NCT01975376|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Last Post-Baseline Measurement||Baseline, last post-baseline measurement (any time up to Week 140)|"Analysis was performed on FAS. Here, N signifies number of participants who were evaluable for this outcome measure."|||Percent Change||Standard Error|Least Squares Mean
1337344|NCT01975376|Secondary|Nominal Change From Baseline in Low Density Lipoprotein Cholesterol at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies number of participants who were evaluable for this outcome measure."|||mg/dL||Standard Error|Least Squares Mean
1337345|NCT01975376|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Error|Least Squares Mean
1337346|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For All-Cause Death|Event rate per 100 participant-years for all-cause death (adjudicated by adjudication committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337347|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Arterial Revascularizations|Event rate per 100 participant-years for first occurrence of any arterial revascularizations (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337348|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Percutaneous Coronary Intervention (PCI)|Event rate per 100 participant-years for first occurrence of PCI (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337523|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working||Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of impairment while working||Standard Deviation|Mean
1337351|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Hospitalization for Congestive Heart Failure (CHF)|Event rate per 100 participant-years for first occurrence of hospitalization for CHF (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for congestive heart failure (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337352|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337353|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Non-Fatal Stroke|Event rate per 100 participant-years for first occurrence of non-fatal stroke (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337354|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For Fatal Stroke|Event rate per 100 participant-years for fatal stroke (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337355|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Stroke (Fatal or Non-Fatal), of Any Etiology|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal), of any etiology (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal), of any etiology (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337356|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Stroke (Fatal or Non-Fatal)|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337357|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Non-Fatal Myocardial Infarction|Event rate per 100 participant-years for first occurrence of non-fatal MI (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337358|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For Fatal Myocardial Infarction|Event rate per 100 participant-years for fatal MI (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337378|NCT01975220|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1337359|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Myocardial Infarction (Fatal or Non-Fatal)|Event rate per 100 participant-years for first occurrence of any MI (fatal or non-fatal) (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any MI (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337360|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For Cardiovascular Death|Event rate per 100 participant-years for cardiovascular death (adjudicated by adjudication committee) was reported. Cardiovascular death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other cardiovascular causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of cardiovascular death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337361|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of Cardiovascular Death, Non-Fatal Myocardial Infarction, Non-Fatal Stroke and Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina (adjudicated by adjudication committee) was reported. Cardiovascular death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other cardiovascular causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of cardiovascular death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337362|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina needing urgent revascularization (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337363|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infarction, or Non-Fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, or non-fatal stroke (adjudicated by adjudication committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of the all-cause death, non-fatal MI, or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337364|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infraction, Non-Fatal Stroke, or Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337379|NCT01975220|Primary|AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin|AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1337582|NCT01972776|Primary|Change From Baseline in Absolute Number of Sputum Neutrophils (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337365|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of Cardiovascular Death, Non-Fatal Myocardial Infraction, or Non-Fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of CV death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. Cardiovascular death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other cardiovascular causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of the CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337366|NCT01975376|Primary|Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event|Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death (defined as sudden cardiac death, fatal myocardial infarction [MI], death due to heart failure, death due to stroke [fatal ischemic stroke or fatal stroke of undetermined etiology], or death due to other cardiovascular causes) non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)|Full analysis set (FAS): all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
1337367|NCT01975285|Secondary|Patient Satisfaction With Pain Management|Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days||||Scores on a scale||Standard Deviation|Mean
1337368|NCT01975285|Secondary|Patient Satisfaction With Regional Nerve Block|Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days||||Scores on a scale||Standard Deviation|Mean
1337369|NCT01975285|Secondary|Length of Analgesia|Time in days and/or hours|3 days||||Hours||Inter-Quartile Range|Median
1337370|NCT01975285|Secondary|Opioid Consumption|Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|3 days||||Opioids consumption mg||Standard Deviation|Mean
1337371|NCT01975285|Primary|Postoperative Pain|"Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain and 10 indicates= The worst possible pain"|3 days||||Scores on a scale||Standard Deviation|Mean
1337372|NCT01975246|Secondary|The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period|Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed.|baseline and week 8|FAS|||percentage of participants||95% Confidence Interval|Number
1337373|NCT01975246|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|FAS|||mmHg||Standard Error|Mean
1337374|NCT01975246|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period.|||mmHg||Standard Error|Mean
1337375|NCT01975220|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1337376|NCT01975220|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin|Cmax (maximum measured concentration of the analyte in plasma); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1337377|NCT01975220|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin|Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1337380|NCT01975220|Primary|Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin|Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): This set includes all subjects of the Treated set (TS) who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1337381|NCT01975090|Secondary|Number of Participants With IVC Filter Related Complications|IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).|6months|Freedom from IVC Filter Related Complications was assessed by the site and reviewed by an Independent Core Lab. All subjects that had data collected were included in the analysis for population.|||participants|||Number
1337382|NCT01975090|Primary|Number of Subjects That Reported Clinical Success|"A Composite Endpoint including:~Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications"|6 Months||||Participants|||Count of Participants
1337383|NCT01974895|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|"A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 – Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
1337384|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010"|During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
1337385|NCT01974895|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|"pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
1337386|NCT01974895|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|"MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
1337387|NCT01974895|Secondary|Duration of Solicited Local and General Symptoms|"Duration was defined as number of days with any grade of local and general symptoms.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Days||Full Range|Median
1337407|NCT01974323|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported “Very good” or “Excellent” at Week 12 are reported.|Week 12|Intent-to-Treat: all randomized patients with data at this time point|||Percentage of Patients|||Number
1337388|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|"Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
1337389|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0°C.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
1337390|NCT01974895|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
1337391|NCT01974895|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1337392|NCT01974895|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1337393|NCT01974895|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|"HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1337406|NCT01974323|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1337457|NCT01973439|Primary|Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0||||h*mg/L||95% Confidence Interval|Geometric Mean
1337394|NCT01974895|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1337395|NCT01974895|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1337396|NCT01974817|Primary|Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis|Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.|12 months||||µg/ml||95% Confidence Interval|Geometric Mean
1337397|NCT01974752|Secondary|Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine|Overall Survival|From Randomization, up until death assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).|||Number of Overall Survival Events|||Number
1337398|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR|Percent change in tumour size at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).|||percent change||Standard Deviation|Mean
1337399|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR|ORR at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|Full Analysis Set|||number of responders|||Number
1337400|NCT01974752|Primary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.|Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).|||number of progression events|||Number
1337401|NCT01974700|Secondary|Number of Participants Who Returned to Work|The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.|6 months - 12 months||||participants|||Number
1337402|NCT01974700|Secondary|Number of Participants Who Returned to Daily Activities.|The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.|6 months - 12 months||||participants|||Number
1337403|NCT01974700|Primary|Incidence of Seizure|Reported via patient in follow-up phone call.|6 mo - 1 Year from Operative Procedure||||participants|||Number
1337404|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1337405|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1337408|NCT01974323|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Percent Change in Lesion Count||Standard Error|Least Squares Mean
1337409|NCT01974323|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Total Lesion Counts||Standard Error|Least Squares Mean
1337410|NCT01974323|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Number of Noninflammatory Lesions||Standard Error|Mean
1337411|NCT01974323|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Number of Inflammatory Lesions||Standard Error|Mean
1337412|NCT01974323|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1337413|NCT01974245|Other Pre-specified|Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks||12 weeks|||||||
1337414|NCT01974245|Secondary|Change From Baseline in C-reactive Protein at 12 Weeks||12 weeks|||||||
1337415|NCT01974245|Primary|Change From Baseline in Interleukin-6 at 12 Weeks.||12 weeks||||pg/mL||Standard Deviation|Mean
1337416|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
1337417|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
1337418|NCT01974141|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Scores on a Scale||Standard Deviation|Mean
1337419|NCT01974141|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported “Very good” or “Excellent” at Week 12 are reported.|Week 12|Intent-to-Treat: all randomized patients with data at this time point, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
1337479|NCT01973218|Secondary|The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.|The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints|||IU/mL||95% Confidence Interval|Geometric Mean
1337583|NCT01972776|Primary|Change From Baseline in Lung Clearance Index (LCI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337420|NCT01974141|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percent Change in Lesion Count||Standard Error|Least Squares Mean
1337421|NCT01974141|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Total Lesion Counts||Standard Error|Least Squares Mean
1337422|NCT01974141|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Number of Noninflammatory Lesions||Standard Error|Mean
1337423|NCT01974141|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Number of Inflammatory Lesions||Standard Error|Mean
1337424|NCT01974141|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
1337425|NCT01974050|Other Pre-specified|Pregnancy Outcome|Pregnancy outcome including termination, preterm birth, term birth or stillbirth|9 months|||||||
1337426|NCT01974050|Other Pre-specified|Pregnancy Complication|Problems reported during pregnancy|9 months|||||||
1337427|NCT01974050|Other Pre-specified|Number of Participants With a Fever in Days 0 to 2 Post-vaccination|Number of participants with any fever on days 0 to 2 post-vaccination|2 days||||Participants|||Count of Participants
1337428|NCT01974050|Secondary|Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy|Feasibility of text messaging to monitor pregnancy outcomes through the end of pregnancy: Number of women enrollees who continue to text pregnancy-related outcomes through the end of their pregnancy|9 months||||Participants|||Count of Participants
1337429|NCT01974050|Secondary|Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV|Number of enrollees who text temperature-related information for the d0-2 period post-vaccination|on vaccination day and the next 2 days (D0-2)||||participants|||Number
1337430|NCT01974050|Primary|Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age|Number of eligible pregnant women <20 weeks gestational age who receive IIV who will be willing to enroll in a text messaging-based vaccine adverse event monitoring program|3 months||||Participants|||Count of Participants
1337431|NCT01973777|Secondary|Acceptability|patient-reported acceptability|12 months||||participants|||Number
1337432|NCT01973777|Secondary|Complication|infection, perforation, pregnancy|12 months||||participants|||Number
1337433|NCT01973777|Primary|Expulsion Rate|The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus|at 6-8 weeks||||participants|||Number
1337434|NCT01973608|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs|TEAE was defined as an AE that started on or after the first administration of SBRT. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.|||subjects|||Number
1337480|NCT01973218|Secondary|The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.|Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||percentage of subjects||95% Confidence Interval|Number
1337435|NCT01973608|Secondary|Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|BOR was defined as a confirmed complete response (CR) or partial response (PR) during second-line treatment. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|"Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||subjects|||Number
1337436|NCT01973608|Primary|Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)|DLT was defined as any Grade>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to <= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 8 x upper limit of normal (ULN)/total bilirubin < 5 x ULN resolving to <= Grade 1 in <7 days after medical management; Grade 3 diarrhea controlled with maximal medical management within 72 hours; Grade 4 lymphopenia that resolves to <= Grade 1 within 7 days & with no clinical manifestations; Grade 3 lab abnormality with no clinical correlation and resolves to <= Grade 1 within 7 days with adequate medical management Tumor flare defined as local pain, irritation or rash localized at sites of known/suspected tumor.|Baseline up to Day 21|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.|||subjects|||Number
1337437|NCT01973595|Secondary|Diet Quality|"Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).~High component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.~National averages total score: children: 54.9 [4-8 years] and adults: 57.4 [31-50 years])"|Three week almond intervention vs. three week no almond intervention|29 Parents and 29 children were analyzed separately for almonds and no almond consumption; one parent-child pair withdrew prior to no almond consumption control.|||units on a scale||Standard Error|Mean
1337438|NCT01973595|Secondary|Gastrointestinal Function|Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.|Pre-baseline (Week 0) and Week 3 of each intervention|29 parents and 29 children consumed almonds n=58; one parent-child pair withdrew prior to no almond consumption control intervention n=56; parents and children were analyzed for almonds and no almond consumption.|||average stools per week||Standard Error|Mean
1337439|NCT01973595|Secondary|Inflammatory Status|Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four.|Change between Baseline to Week 4|Parents (Almonds baseline, n=29, final n=29, No almonds baseline n=28, final n= 28; one parent withdrew prior to no almond consumption control intervention) were analyzed for almonds and no almond consumption, no children were included in this analysis.|||ng/ml||Standard Error|Mean
1337440|NCT01973595|Primary|Gut Microbiota Community Composition|The mean of the change between baseline and final time points in stool lactic acid bacteria counts [log(CFU)] was compared for each study arm.|Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention|Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed.|||log (CFU)||Standard Error|Mean
1337441|NCT01973491|Secondary|Number of Subjects Experiencing Injection Site Reactions (ISRs)|Treatment-emergent ISRs were defined as any ISR with a start date on or after the date of first dose and within 7 days after the date of last dose in the current study. Injection site reactions were identified as erythema, induration, pruritus, nodules and/or cysts, ecchymosis, pain and local edema.|Baseline up to Week 22|The SAF Analysis Set included all subjects who received at least 1 dose of IMP.|||subjects|||Number
1337442|NCT01973491|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the date of first dose and within 28 days after the date of last dose in the current study. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Week 25|The SAF Analysis Set included all subjects who received at least 1 dose of IMP.|||subjects|||Number
1337443|NCT01973491|Secondary|Change From Baseline in Total Multiple Sclerosis Functional Composite (MSFC) Score at Week 20|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).|Baseline (Week 0) and Week 20|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||Z-score||Standard Deviation|Mean
1337444|NCT01973491|Secondary|Change From Baseline in Total Expanded Disability Status Scale (EDSS) Score at Week 20|EDSS is an ordinal scale in half-point increments that qualifies disability in subjects with Multiple Sclerosis. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as any other neurological findings due to Multiple Sclerosis. Total EDSS score ranges from 0 (normal neurological examination) to 10 (death due to MS). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).|Baseline (Week 0) and Week 20|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||units on a scale||Standard Deviation|Mean
1337445|NCT01973491|Secondary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse.|Baseline up to Week 36|The mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.|||days||95% Confidence Interval|Median
1337446|NCT01973491|Secondary|Mean Annualized Relapse Rate|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).|Week 20|Analysis population included subset of mITT analysis set who had relapse.|||relapse per year||Standard Deviation|Mean
1337447|NCT01973491|Secondary|Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans.|Weeks 0, 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those subjects who were evaluable at the specified time point.|||milliliter||Standard Deviation|Mean
1337448|NCT01973491|Secondary|Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans.|Week 0, 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable at the specified time point."|||lesions||Standard Deviation|Mean
1337449|NCT01973491|Secondary|Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions|T2 lesions were measured using MRI scans.|Weeks 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||lesions||Standard Deviation|Mean
1337450|NCT01973491|Secondary|Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).|Baseline (Weeks -8, -4, 0), Week 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||milliliter||Standard Deviation|Mean
1337451|NCT01973491|Secondary|Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).|Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number Analyzed” signifies those subjects who were evaluable at the specified time point.|||lesions||Standard Deviation|Mean
1337452|NCT01973491|Secondary|Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)|The number of T1 CELs were measured using MRI scans.|Weeks 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number Analyzed” signifies those subjects who were evaluable at the specified time point.|||lesions||Standard Deviation|Mean
1337453|NCT01973491|Primary|Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans|T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.|Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)|The modified intention-to-treat (mITT) analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.|||lesions||Standard Deviation|Mean
1337454|NCT01973439|Primary|Cmax of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.|Week 4||||mg/L||95% Confidence Interval|Geometric Mean
1337455|NCT01973439|Primary|AUC(0-24) of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication|Week 4||||h*mg/L||95% Confidence Interval|Geometric Mean
1337456|NCT01973439|Primary|Cmax of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0||||mg/L||95% Confidence Interval|Geometric Mean
1337458|NCT01973413|Secondary|Glycemic Events|"Number of nights with >= 1 hypo- and hyperglycemic event occurring overnight during the camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.|||nights with >= 1 event|Participants||Number
1337459|NCT01973413|Secondary|Overnight Glucose|"Mean overnight glucose during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.|||mg/dL|Participants|Standard Deviation|Mean
1337460|NCT01973413|Primary|Percent Time Near Normoglycemia|"Percent of time in a glucose target range of 70-150 mg/dl during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.|||percentage of time|Participants|Inter-Quartile Range|Median
1337461|NCT01973387|Secondary|Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms|The most common disease-related symptoms associated with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (fatigue, weight loss, fevers, night sweats, and abdominal discomfort/splenomegaly) were reported by grade.|From the date of randomization to disease progression (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||participants|||Number
1337462|NCT01973387|Secondary|Number of Participants With Sustained Hematologic Improvement|Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.|From the date of randomization to disease progression (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||participants|||Number
1337463|NCT01973387|Secondary|Overall Survival (OS)|Overall survival was defined as the interval between the date of randomization and the date of death from any cause.|From the date of randomization to the date of death (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||months||95% Confidence Interval|Median
1337464|NCT01973387|Secondary|Overall Response Rate (ORR)|ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- >=50% drop in lymphocyte count from baseline or <=4.0*10^9/L with following: >=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, >=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils >1.5*10^9/L, Platelets>100000/mcL and Hgb>11 g/dL or >=50% improvement over baseline in all.|From the date of randomization to disease progression (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||participants|||Number
1337521|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment||Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of activity impairment||Standard Deviation|Mean
1337465|NCT01973387|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for progressive disease (PD): New enlarged nodes greater than (>)1.5 centimeter (cm), new hepatomegaly or splenomegaly, or other organ infiltrates; greater than or equal to (>=)50 percent (%) increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; New cytopenia (Hemoglobin b [Hgb] or platelets) attributable to chronic lymphocytic leukemia (CLL) and transformation to a more aggressive histology.|From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||months||95% Confidence Interval|Median
1337466|NCT01973348|Other Pre-specified|Significant Ocular Deviation Increase From the Baseline|The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.|3 Months||||Participants|||Count of Participants
1337467|NCT01973348|Other Pre-specified|Reverse Amblyopia|it is defined that the strong eye of the patient decreases two logMAR lines over 3 months.|3 Months||||Participants|||Count of Participants
1337468|NCT01973348|Primary|Visual Acuity Change During 12 Weeks|Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.|12 weeks|Visual acuity change over 12 weeks|||logMAR||Standard Deviation|Mean
1337469|NCT01973231|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of any of the trial products.|||events|||Number
1337470|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post-baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||percentage (%) of subjects|||Number
1337471|NCT01973231|Secondary|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)|Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||percentage (%) of subjects|||Number
1337472|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||percentage (%) of subjects|||Number
1337473|NCT01973231|Secondary|Change in Body Weight From Baseline|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing body weight post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the body weight analysis.|||kg||Standard Deviation|Mean
1337474|NCT01973231|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing FPG post baseline data, 194 and 189 subjects in liraglutide and lixisenatide treatment group, respectively were included in the FPG analysis.|||mmol/L||Standard Deviation|Mean
1337475|NCT01973231|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing values were imputed using predicted values from the mixed model for repeated measurements (MMRM) model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1337476|NCT01973218|Secondary|The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.|The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through Day 61|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.|||number of subjects|||Number
1337477|NCT01973218|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.|The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through day 7 after each vaccination|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.|||Number of subjects|||Number
1337478|NCT01973218|Secondary|The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.|The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.|Day 61/Day 1|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||Ratio||95% Confidence Interval|Geometric Mean
1343115|NCT01903863|Secondary|Time to Therapeutic aPTT|Compared time in hours to goal aPTT for control versus treatment group|ECMO course (median 198 hours)||||hours||Inter-Quartile Range|Median
1337481|NCT01973218|Secondary|The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.|Day 61/ Day 1|Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints|||Ratio||95% Confidence Interval|Geometric Mean
1337482|NCT01973218|Secondary|The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.|The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||Titers||95% Confidence Interval|Geometric Mean
1337483|NCT01973218|Primary|Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.|Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.|Day 1 and Day 61|Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||percentage of subjects||95% Confidence Interval|Number
1337484|NCT01973205|Secondary|Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.|Number of subjects who are free of phonophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing phonophobia free status at 2 hours (AA: N=403, Placebo: N = 411).|||participants|||Number
1337485|NCT01973205|Secondary|Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.|Number of subjects who are free of photophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing photophobia free status at 2 hours (AA: N=403, Placebo: N = 411).|||participants|||Number
1337486|NCT01973205|Primary|Number of Subjects Who Are Nausea Free at the 2-hour Assessment|Number of subjects who are nausea free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N=415) and had a non-missing nausea free status at 2 hours (AA: N=403, Placebo N= 411).|||participants|||Number
1337487|NCT01973205|Primary|Number of Subjects Who Are Pain Free at the 2-hour Assessment|Number of subjects who are pain free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing pain free status at 2 hours (AA: N=408, Placebo: N = 415).|||participants|||Number
1337488|NCT01973062|Secondary|Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI|Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data|At day 11|Only one patient registered. No patient data analyzed||||||
1337489|NCT01973062|Secondary|Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.|Number of patients with toxicities related to the study drug|Up to 30 days following the last dose of study treatment|Only one patient registered. No patient data analyzed||||||
1337490|NCT01973062|Secondary|Overall Survival|The number of patients alive up to two years after treatment|Up to 2 years|Only one patient registered. No patient data analyzed||||||
1337491|NCT01973062|Secondary|Progression Free Survival|The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI|Up to 2 years|Only one patient registered. No patient data analyzed||||||
1337492|NCT01973062|Primary|Radiographic Response Assessed by MRI or FDG-PET/MRI|Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids|Up to 2 years|Only one patient registered. No patient data analyzed||||||
1337493|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||bpm||Standard Error|Least Squares Mean
1337494|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||nnHg||Standard Error|Least Squares Mean
1337495|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
1337496|NCT01972841|Secondary|Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.|||bpm||Standard Error|Least Squares Mean
1337497|NCT01972841|Secondary|Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
1337498|NCT01972841|Secondary|Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
1337499|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||bpm||Standard Error|Least Squares Mean
1337500|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
1337501|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
1337502|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1337503|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)|Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
1337504|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)|Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPM analysis set (ABPMAS), which consisted of all participants in the SAF for whom at least 1 ABPM variable could be calculated at baseline and postbaseline visit. Participants with data available at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
1337505|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume|PVR volume was assessed by ultrasonography or a bladder scanner.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|SAF participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mL||Standard Deviation|Mean
1337506|NCT01972841|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.|From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)|Safety Analysis Set (SAF), which comprised all randomized participants who received ≥ 1 dose of double-blind treatment and excluded participants from one site.|||Participants|||Count of Participants
1337507|NCT01972841|Secondary|Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337508|NCT01972841|Secondary|Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337509|NCT01972841|Secondary|Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337510|NCT01972841|Secondary|Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337511|NCT01972841|Secondary|Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337512|NCT01972841|Secondary|Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT|The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337513|NCT01972841|Secondary|Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337514|NCT01972841|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT|The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337515|NCT01972841|Secondary|Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT|The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.|Weeks 4, 8 , 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337516|NCT01972841|Secondary|Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337517|NCT01972841|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337518|NCT01972841|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337519|NCT01972841|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT|The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of particpants|||Number
1337520|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in TS-VAS|The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and week 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1337584|NCT01972776|Primary|Percentage of Participants With Adverse Events (Part 1)|Adverse events were counted and corresponding percentages were tabulated.|14 days|All randomized part 1 participants|||percentage of participants|||Number
1337524|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed|The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of work time missed||Standard Deviation|Mean
1337525|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
1337526|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
1337527|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
1337528|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
1337529|NCT01972841|Secondary|Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
1337530|NCT01972841|Secondary|PGIC Scale: Impression in General Health at Week 12 and EoT|The PGIC was a 2-part questionnaire, assessing both the change in the patient’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Week 12 and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337531|NCT01972841|Secondary|Patient’s Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT|The PGIC was a 2-part questionnaire, assessing both the change in the patient’s overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Week 12 and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
1337532|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social|The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1337533|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep|The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1337534|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern|The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1337535|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping|The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1339218|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1337536|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score|The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1337537|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score|The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1337538|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT .|||units on a scale||Standard Error|Least Squares Mean
1337539|NCT01972841|Secondary|Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT|The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||days||Standard Error|Mean
1337540|NCT01972841|Secondary|Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT|The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.|Weeks 4, 8,12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||days||Standard Error|Mean
1337541|NCT01972841|Secondary|Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT|The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||incontinence-free days||Standard Error|Mean
1337542|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours|The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8 and 12 (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.|||pads||Standard Error|Least Squares Mean
1337543|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used||Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.|||pads||Standard Error|Least Squares Mean
1337544|NCT01972841|Secondary|Number of Pads Used at Weeks 4, 8, 12 and EoT|The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.|Weeks 4, 8 and 12 (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.|||pads||Standard Error|Mean
1337545|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours|The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.|||nocturia episodes||Standard Error|Least Squares Mean
1337546|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes||Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.|||nocturia episodes||Standard Error|Least Squares Mean
1337547|NCT01972841|Secondary|Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT|A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.|||nocturia episodes||Standard Error|Mean
1337585|NCT01972724|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24|The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at baseline. A negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population was defined as all participants who took at least 1 dose of the study drug.|||mmol/L||Standard Deviation|Mean
1337548|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency episode at baseline were included in the analysis.|||urgency episodes||Standard Error|Least Squares Mean
1337549|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1337550|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes||Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1337551|NCT01972841|Secondary|Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis.|||urgency incontinence episodes||Standard Error|Mean
1337552|NCT01972841|Secondary|Change From Baseline to EoT in Corrected Micturition Frequency|Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.|Baseline and Week 12|FAS. LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
1337553|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition||Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||mL||Standard Error|Least Squares Mean
1337554|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours||Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point data were included in the analysis.|||micturitions||Standard Error|Least Squares Mean
1337555|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours||Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||incontinence episodes||Standard Error|Least Squares Mean
1337556|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes||Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
1337557|NCT01972841|Secondary|Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT|The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||incontinence episodes||Standard Error|Mean
1337558|NCT01972841|Secondary|Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)|The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1337559|NCT01972841|Secondary|Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
1337560|NCT01972841|Secondary|Change From Baseline to EoT in Mean Volume Voided Per Micturition|The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||mL||Standard Error|Least Squares Mean
1337561|NCT01972841|Primary|Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
1337586|NCT01972724|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The change from baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24. A negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population was defined as all participants who took at least 1 dose of the study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1337587|NCT01972659|Secondary|Postoperative Morphine Consumption||after 12 hour surgery|||||||
1337562|NCT01972841|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.|Baseline and EoT (up to 12 weeks)|FAS comprised all RAS patients who took ≥ 1 dose of double-blind treatment after randomization, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from one site. Last observation carried forward (LOCF) was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
1337563|NCT01972776|Secondary|Change From Baseline in Scond/Sacin as Measured by Multiple Breath Nitrogen Washout (MBNW) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337564|NCT01972776|Secondary|Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337565|NCT01972776|Secondary|Change From Baseline in Percentage Sputum Neutrophils (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337566|NCT01972776|Secondary|Tmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337567|NCT01972776|Secondary|Cmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337568|NCT01972776|Secondary|AUC0-24 (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337569|NCT01972776|Secondary|Change From Baseline in Forced Expirtory Flow 25-75 (FEF25-75), Forced Expiratory Volume 3 (FEV3)/Forced Vital Capacity (FVC), 1-(FEV3/FVC), FEV6, FEV1/FEV6 and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337570|NCT01972776|Secondary|Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) (Part 1)|Lung clearance index (LCI) is a measure of abnormal ventilation distribution derived from the multiple breath inert gas washout (MBW) technique. LCI is equal to the cumulative expired volume/functional residual capacity. LCI was measured at baseline and day 14. LCI was analyzed using a Bayesian model for repeated measurements. The model may investigate effects for pre-dose baseline, treatment, time, age, COPD class, treatment by time interaction, and baseline by time interaction. A positive change from baseline indicates improvement.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||index score||Standard Error|Mean
1337571|NCT01972776|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Part 1)|FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry and performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||mL||Standard Error|Mean
1337572|NCT01972776|Secondary|Change From Baseline in Chemokine (C-X-C Motif) Receptor 2 (CXCR2) Receptor Occupancy (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CXCR2 receptor occupancy on neutrophils. A positive change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||percent change|||Number
1337573|NCT01972776|Secondary|Change From Baseline in Cluster of Differentiation 11b (CD11b) (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CD11b expression on neutrophils. A negative change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||percentage change|||Number
1337574|NCT01972776|Secondary|Tmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.|||hours||Full Range|Median
1337575|NCT01972776|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.|||hours||Full Range|Median
1337576|NCT01972776|Secondary|Cmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.|||ng/mL||Standard Deviation|Mean
1337577|NCT01972776|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.|||ng/mL||Standard Deviation|Mean
1337578|NCT01972776|Secondary|AUCtau, Steady State (AUCtau,ss) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.|||ng*h/mL||Standard Deviation|Mean
1337579|NCT01972776|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval, Tau (AUCtau) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.|||ng*h/mL||Standard Deviation|Mean
1337580|NCT01972776|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337581|NCT01972776|Primary|Change From Baseline in Transition Dyspnea Index (TDI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
1337588|NCT01972659|Secondary|Rocuronium Supplementation||during surgery|||||||
1337591|NCT01972568|Primary|Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||percentage of subjects|||Number
1337592|NCT01972568|Post-Hoc|High Disease Activity Subpopulation (SLEDAI-2K >=10 at Screening): Logistic Regression of Percentage of Subjects With SRI-6 Response at Week 24|SRI-6 response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 6 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Logistic regression of number of subjects with SRI-6 response was analyzed by using Logistic regression model.|Week 24|mITT_HDA analysis set included mITT population with high disease activity (HDA) defined as screening SLE Disease Activity Index (SLEDAI) >=10.|||percentage of subjects|||Number
1337593|NCT01972568|Secondary|Change From Week 0 (Day 1) in SF-36 Components at Week 24|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.|Week 0 (Day 1) and Week 24|"mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure at specified categories."|||units on a scale||Standard Deviation|Mean
1337594|NCT01972568|Secondary|Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)|Safety analysis set included all randomized subjects who received at least 1 dose of IMP.|||percentage of subjects|||Number
1337595|NCT01972568|Secondary|Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24|The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and <=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by <10% (defined as <0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||percentage of subjects|||Number
1337596|NCT01972568|Secondary|Time From Randomization to First SRI Response During Treatment Period|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.|Baseline up to 24 Weeks|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||weeks||95% Confidence Interval|Median
1337597|NCT01972568|Secondary|Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24|Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.|Screening and Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||mg per day||Standard Deviation|Mean
1337598|NCT01972568|Secondary|Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24|The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||percentage of subjects|||Number
1337610|NCT01972516|Primary|Progression-Free Survival (PFS) Comparison|"To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)"|2 Years|Reporting the number of cycles each patient completed. Each cycle = 4 weeks.|||Cycles|||Number
1337611|NCT01972464|Post-Hoc|Questionnaire on Smoking Urges (QSU)-Brief Score|Scale is scored from 10 to 70. Higher scores indicate more severe symptoms|treatment period; baseline through week 8, measured weekly||||units on a scale||Standard Deviation|Mean
1337612|NCT01972464|Post-Hoc|Time to Relapse|The Outcome Measure is reporting the time in weeks to relapse|baseline through 3-month post trial follow-up||||weeks||Inter-Quartile Range|Median
1337599|NCT01972568|Secondary|Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity|BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone >20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects whose CS dose >=10 mg at Screening.|||percentage of subjects|||Number
1337600|NCT01972568|Primary|Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician’s Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||percentage of subjects|||Number
1337601|NCT01972529|Other Pre-specified|Number of Participants Experiencing an Adverse Event|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Treatment-emergent adverse events (TEAEs) were defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.|From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years|Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
1337602|NCT01972529|Other Pre-specified|Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After a Scheduled Procedure|The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss (requires transfusion (severe)), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.|Baseline (Visit 2) up to 7 days post scheduled procedure|FAS|||Percentage of participants|||Number
1337603|NCT01972529|Secondary|Change From Baseline in Platelet Count on the Scheduled Procedure Day|Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.|Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)|FAS|||Platelet count x 10^9/per liter||Standard Deviation|Mean
1337604|NCT01972529|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on the Scheduled Procedure Day|Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10^9/L on the procedure day. Participants with missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10^9/L in the analysis, (i.e. Non-responders).|Day 10 to Day 13 (Visit 4)|FAS|||Percentage of participants||95% Confidence Interval|Number
1337605|NCT01972529|Primary|Percentage of Participants Who Did Not Require a Platelet Transfusion or Any Rescue Procedure for Bleeding After Randomization Following a Scheduled Procedure|Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).|Baseline (Visit 2) up to 7 days following a scheduled procedure|Full analysis Set (FAS) was defined as the group of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1337606|NCT01972516|Secondary|Quality of Life (QOL) Evaluation|To evaluate the impact of treatment with Tivozanib versus placebo alone on the Quality of Life (QOL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC QLQ-Ovarian Cancer Module (EORTC QLQ-OV28) for functioning and symptoms.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
1337607|NCT01972516|Secondary|Toxicity Rate Comparison|To compare rates of toxicity with and without maintenance therapy with Tivozanib.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
1337608|NCT01972516|Secondary|Overall Survival (OS) Evaluation|To evaluate the overall survival with and without maintenance therapy with Tivozanib in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
1337609|NCT01972516|Secondary|Progression-Free Survival (PFS) Evaluation|To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
1337614|NCT01972464|Primary|Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention|Feasibility in retention will be shown by at least 70% of women randomized to the progesterone group reamaining in the study at the 3-month follow-up|From randomization to 3-month follow-up: up to 5 months||||Participants|||Count of Participants
1337615|NCT01972464|Primary|Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment|Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken|8 weeks|Adherence to treatment as measured by mean (SD) doses of study medication taken by women in each arm of the study.|||doses of medication||Standard Deviation|Mean
1337616|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||mOsm/L|eyes|Standard Deviation|Mean
1337617|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||mOsm/L|eyes|Standard Deviation|Mean
1337618|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 6 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||mOsm/L|eyes|Standard Deviation|Mean
1337619|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 3 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||mOsm/L|eyes|Standard Deviation|Mean
1337620|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||seconds|eyes|Standard Deviation|Mean
1337621|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 6 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||seconds|eyes|Standard Deviation|Mean
1337622|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||seconds|eyes|Standard Deviation|Mean
1337623|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 3 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||seconds|eyes|Standard Deviation|Mean
1337624|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 6 Months Compared to Baseline.|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||ETDRS letters|eyes|Standard Deviation|Mean
1337625|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||ETDRS letters|eyes|Standard Deviation|Mean
1337891|NCT01969435|Secondary|Efficacy as Measured by Response Rates|"The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion.~Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma"|Up to Day 100||||percentage of participants|||Number
1337626|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||ETDRS letters|eyes|Standard Deviation|Mean
1337627|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 3 Months Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||ETDRS letters|eyes|Standard Deviation|Mean
1337628|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 6 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
1337629|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 6 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
1337630|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 3 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
1337631|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 3 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer’s tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
1337632|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
1337633|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 6 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
1337892|NCT01969435|Primary|Treatment-related Mortality (TRM)|TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant|100 days||||percentage of participants|||Number
1339219|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1337634|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
1337635|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 3 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
1337636|NCT01972438|Secondary|Number of Participants Withdrawn From the Study Treatment Due to Vision Loss, Adverse Events or Treatment Failure||Study Duration, up to 24 months||||participants|||Number
1337637|NCT01972438|Secondary|Number of Systemic and Ocular Toxicities and Adverse Events||Study Duration, up to 24 months||||adverse events|||Number
1337638|NCT01972438|Primary|Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale in the Study Eye From Baseline to Month 3.|A ≥ 50% reduction in the combined score was considered a treatment success. While the design is a crossover study, the primary outcome was assessed after the first period at Month 3. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 months|This analysis is conducted on the per-protocol population, defined as those who adhered to the protocol prior to drug unavailability, not on the intent-to-treat population due to lack of visit information beyond baseline for 3 participants. Three never started drug: one was unable to donate blood, one was ineligible at screening and one died.|||participants|eyes||Number
1337639|NCT01972308|Secondary|Change in Urgent Office Visit|Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit.|one year||||urgent visits per 6 months||95% Confidence Interval|Least Squares Mean
1337640|NCT01972308|Secondary|Risk of Prednisone Bursts|a new dose or an increase in already prescribed prednisone dose|baseline and one year||||risk of prednisone bursts||95% Confidence Interval|Least Squares Mean
1337641|NCT01972308|Secondary|Change in Hospitalizations|Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.|one year||||hospitalizations per 6 months||95% Confidence Interval|Least Squares Mean
1337642|NCT01972308|Secondary|Change in Asthma-related Quality of Life|Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.|baseline to one year||||units on a scale||95% Confidence Interval|Least Squares Mean
1337643|NCT01972308|Secondary|Change in Emergency Department(ED) Visits at One Year|Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint|one year||||visits per 6 months||95% Confidence Interval|Least Squares Mean
1337644|NCT01972308|Primary|Change in Asthma Control at One Year|"Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion.~Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score > 1.5 is considered inadequate control."|baseline and 1 year|18 years or more, physician’s diagnosis of asthma, prescribed an inhaled-steroid for asthma, moderate or severe persistent asthma, evidence of reversible airflow obstruction, at least one appointment scheduled with the asthma physician during the 1st 6 months of participation|||units on a scale||95% Confidence Interval|Least Squares Mean
1337645|NCT01972152|Secondary|Glucagon Tmax|Pharmacokinetic parameter: Time to maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||minutes||Standard Deviation|Mean
1337646|NCT01972152|Secondary|Glucagon Cmax|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||pg/ml||Standard Deviation|Mean
1337941|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1337647|NCT01972152|Secondary|Glucagon AUC|Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||min*pg/ml||Standard Deviation|Mean
1337648|NCT01972152|Secondary|Glucose Tex|Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||minutes||Standard Deviation|Mean
1337649|NCT01972152|Secondary|Glucose MAE|Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||mg/dL||Standard Deviation|Mean
1337650|NCT01972152|Secondary|Glucose AUCex|Pharmacodynamic parameter: Area Under the Glucose Excursion Curve|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||min*mg/dL||Standard Deviation|Mean
1337651|NCT01972152|Secondary|Glucose Tmax|Pharmacodynamic parameter: Time to Maximum Glucose Concentration|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||minutes||Standard Deviation|Mean
1337652|NCT01972152|Secondary|Glucose Cmax|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||mg/dL||Standard Deviation|Mean
1337653|NCT01972152|Secondary|Glucose Area Under the Curve (AUC)|Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||min*mg/dL||Standard Deviation|Mean
1337654|NCT01972152|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment group|From first dose until completion of the post-treatment follow-up visit, up to 6 weeks|All subjects receiving treatment were included in this analysis.|||events|||Number
1337655|NCT01971723|Primary|Creatine-Kinase Outcomes||Baseline, 2-week mark, 4-week mark||||mkat/L||Standard Deviation|Mean
1337656|NCT01971723|Primary|Sex-hormone Binding Globulin Outcomes||Baseline, 2-week mark, 4-week mark||||nmol/l||Standard Deviation|Mean
1337657|NCT01971723|Primary|Cortisol Outcomes||Baseline, 2-week mark, 4-week mark||||ug/dl||Standard Deviation|Mean
1337658|NCT01971723|Secondary|Volume Performance Outcomes|During the four weeks, the volume ((weight x reps)set 1+(weight x reps)set 2+ (weight x reps)set 3….. ) will be calculated and measured for each exercise in each lifting session.|4 Weeks||||Repetitions||Standard Deviation|Mean
1337659|NCT01971723|Primary|Dihydrotestosterone Outcomes|Measurements for dihydrotestosterone (DHT) will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
1337660|NCT01971723|Primary|Free Testosterone Outcomes|Measurements for free testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
1337661|NCT01971723|Primary|Bio-availableTestosterone Outcomes|Measurements for total testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
1337662|NCT01971723|Primary|Insulin-like Growth Factor-I Outcomes|Measurements for insulin-like growth factor-I will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
1337663|NCT01971723|Primary|Estrogen Outcomes|Measurements for estrogen will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||pg/ml||Standard Deviation|Mean
1337664|NCT01971723|Primary|Total Testosterone Outcomes|Measurements for testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
1339220|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1337667|NCT01971723|Primary|Strength Performance Outcomes|"Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench, and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period.~Each measure was only compared within it's own category against the baseline measurement and against that of the other group at the same time point."|Baseline measures and 4 weeks from start of study||||Kg||Standard Deviation|Mean
1337668|NCT01971645|Secondary|Post-operative Pain Scores|Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.|Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours||||units on a scale||Inter-Quartile Range|Median
1337669|NCT01971645|Primary|Intra-operative and Post-operative Opioid Consumption|Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.|Intra-operative and up to 48 hours post-discharge, an average of 48 hours||||doses||Inter-Quartile Range|Median
1337670|NCT01971593|Other Pre-specified|Serum Creatinine||Baseline, 6 months, 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||mg/dl||Standard Deviation|Mean
1337671|NCT01971593|Secondary|Quality of Life|Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function|Baseline, 6 months, 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||Score on a scale||Inter-Quartile Range|Mean
1337672|NCT01971593|Secondary|6 Minute Walk||Baseline, 6 months, 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||Feet||Standard Deviation|Mean
1337673|NCT01971593|Primary|Galectin 3||Baseline, 6 months and 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||ng/ml||Standard Deviation|Mean
1337674|NCT01971593|Primary|Procollagen III N-Terminal Peptide||Baseline, 6 months and 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||ug/ml||Standard Deviation|Mean
1337675|NCT01971593|Primary|Procollagen N-terminal Peptide 1||Baseline, 6 months and 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||ug/ml||Standard Deviation|Mean
1337676|NCT01971580|Secondary|Quality of Life|Change in Rand 36-item Short Form (SF-36) physical function score (0-100). On the Rand SF-36 questionnaire, a score closer to 100 (higher) suggests lesser disability, while a score closer to 0 (lower) suggests more disability.|12 weeks|In this crossover study, all patients received both therapies. Analysis was performed comparing baseline to after indicated therapy|||Change in score from baseline||95% Confidence Interval|Mean
1337677|NCT01971580|Primary|Change in VO2 Max||Baseline compared to 12 weeks therapy with either ambrisentan or placebo|In this crossover study, all patients received both ambrisentan and placebo. Data was analyzed comparing baseline measures to those after the period on ambrisentan and baseline measures to those after the period on placebo.|||Change in ml/kg min||95% Confidence Interval|Mean
1337678|NCT01971567|Secondary|Change in Baroflex Sensitivity (BRS)|Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system at 1000 Hz, are analyzed using Nevrokard BRS software. Analysis is conducted on the first complete 5-minute epoch. Power spectral densities of systolic blood pressure (SBP) and R-R interval (RRI) oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (HF: 0.15-0.4 Hz). The square-root of the ratio of RRI’s and SBP powers is computed to calculate HF alpha indices, which reflect BRS. The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is then calculated for Sequence UP, DOWN and TOTAL (seq ALL).|8-10 weeks after completion of the intervention|Other entries were excluded due to missing or dropped heartbeats and were excluded from the analysis for continuity|||ms/mm Hg||Standard Error|Mean
1337679|NCT01971567|Secondary|Change in Heart Rate Variability (HRV)|Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds)and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Other entries were excluded due to missing or dropped heartbeats and were excluded from the analysis for continuity|||ms||Standard Error|Mean
1337680|NCT01971567|Secondary|Change From Baseline in EQ-5D|Health-related quality of life will be measured by the EQ-5D. The EQ-5D consists of 5 items assessing an individual's current health status (values from 0-2), yielding scores ranging from 0-10. Higher scores denotes worse outcomes.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention||||units on a scale||Standard Error|Mean
1337681|NCT01971567|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI)|Anxiety will be measured by the Beck Anxiety Inventory (BAI). The BAI is a 21-item questionnaire with response values from 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Data not collected for one participant in the placebo group|||units on a scale||Standard Error|Mean
1337942|NCT01968980|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1337682|NCT01971567|Secondary|Change From Baseline in Beck Depression Inventory - II (BDI-II)|Depression will be measured by the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item questionnaire with response values of 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention||||units on a scale||Standard Error|Mean
1337683|NCT01971567|Secondary|Change in RestRefresh and SleepQual|This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Participants were asked to report a self-rating on how well they felt rested and refreshed (RestRefresh) and to rate the quality of sleep they had (SleepQual). Both questions were rated on a 0 to 4 scale and higher scores denotes better outcomes for each.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Data was not able to be collected for all participants.|||units on a scale||Standard Error|Mean
1337684|NCT01971567|Secondary|Change in Total Sleep Time (TST)|This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Participants recorded the total sleep time (TST) they had each night. The outcome indicates the average increase (in hours) of the amount of sleep that each group reported.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Data was not able to be collected for all participants.|||hours||Standard Error|Mean
1337685|NCT01971567|Secondary|Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset|This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Measurements of sleep onset latency (SOL) and wake after sleep onset (WASO) were recorded in minutes.|Baseline and 8-10 weeks after completion of intervention|Data was not able to be collected for all participants.|||minutes||Standard Error|Mean
1337686|NCT01971567|Primary|Change From Baseline in Insomnia Severity Index (ISI)|The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention||||units on a scale||Standard Error|Mean
1337687|NCT01971554|Secondary|Change From Baseline in 24-Hour Weighted Mean Glucose (24h-WMG) at Day 15|"The 24h-WMG was considered to provide an integrated assessment of the glycemic exposure over the 24-hour period, and was derived from 18 blood samples collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. On each day (Day -1 and Day 14), the WMG was computed as a time-weighted average of the 18 individual measurements."|Baseline and Day 15|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Data from 1 participant at Day 14 (Placebo group) was missing as the participant had to leave the study site.|||mg/dL||Standard Error|Least Squares Mean
1337688|NCT01971554|Secondary|Time to Reach Cmax (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.|||hr||Full Range|Median
1337689|NCT01971554|Secondary|Maximum Plasma Drug Concentration After Dosing (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for Cmax was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.|||μM||Geometric Coefficient of Variation|Geometric Mean
1337690|NCT01971554|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to 24 hours after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for AUC0-24h was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
1337691|NCT01971554|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 14 days|The Safety population consisted of all participants who received at least one dose of study medication.|||Participants|||Number
1337729|NCT01970995|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1337692|NCT01971554|Primary|Number of Participants Who Experienced at Least Once Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 28 days|The Safety population consisted of all participants who received at least one dose of study medication.|||Participants|||Number
1337693|NCT01971554|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15|Blood glucose was measured on a fasting basis (collected after an 8-hour fast). Blood was collected on Day -1 (pre-planned dose), predose on Days 1, 3, 7, and 14, and 24h postdose Day 14 (Day 15). The baseline measurement was computed as the average of the Day -1 and predose Day 1 measurements. FPG is expressed as mg/dL. This change from baseline reflects values for Day 15 FPG minus Day 0 FPG values.|Predose (Baseline) and 24 h postdose Day 14 (Day 15)|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model.|||mg/dL||Standard Error|Least Squares Mean
1337694|NCT01971476|Secondary|Half-Life (t1/2) of Volasertib|This outcome measure presents half-life of Volasertib.|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.|||h||Geometric Coefficient of Variation|Geometric Mean
1337695|NCT01971476|Secondary|Area Under the Concentration-Time Curve (AUC0-∞, Norm) of Volasertib in Plasma|This outcome measure presents dose normalized area under the concentration-time curve of Volasertib in plasma over the time interval from zero extrapolated to infinity.|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1337696|NCT01971476|Secondary|Trough Concentration (Cpre, 2) of Volasertib|"This outcome measure presents pre-dose concentration of Volasertib in plasma immediately before administration of the second dose (Cpre,2).~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data. The number of participants analysed are the number of participants with available data at the timepoint of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1337697|NCT01971476|Secondary|Maximum Measured Concentration (Cmax, Norm) of Volasertib|This outcome measure presents dose normalized maximum measured concentration of Volasertib in plasma (Cmax, norm).|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set (PKS): All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1337698|NCT01971476|Secondary|Overall Survival (OS) [in Leukaemia Patients]|Overall survival was defined as time from first infusion of Volasertib to death from any cause. For patients who were lost to follow-up, OS were censored on the last date the patients were known to be alive.|Up to 849 days.|"Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|||Months||95% Confidence Interval|Median
1337699|NCT01971476|Secondary|Event-Free Survival (EFS) [in Leukaemia Patients]|EFS was defined as the time from the first infusion of Volasertib to the date of PD or relapse, occurrence of secondary malignancy, or death from any cause, whichever occurred first. EFS was censored at the date of last disease assessment for patients who were not reported with PD, relapse, occurrence of secondary malignancy or death.|Up to 849 days.|"Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|||Months||95% Confidence Interval|Median
1337700|NCT01971476|Secondary|Best Overall Response [in Leukaemia Patients]: (Complete Remission (CR)), CR With Incomplete Neutrophil or Platelet Recovery (CRi), Partial Remission (PR), Stable Disease (SD), Progressive Disease (PD) and Death in Aplasia|This outcome measure includes, CR: Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary (EM) disease; absolute neutrophil count ≥ 1.0 x 109/L (1000/μL); platelet count ≥80 x 109/L (80000/μL); independence of red blood cells transfusions. CRi: All CR criteria except for residual neutropenia (<1.0 x 109/L [1000/μL]) or thrombocytopenia (<800 x 109/L [80000/μL]), independence of red blood cell transfusions not required. PR: Decrease of bone marrow blast percentage to 5%-25%; decrease of pretreatment bone marrow (baseline) blast percentage by at least 50%; absence of EM disease. SD: Neither qualifies for CR, CRi, PR or PD. PD: At least one of the criteria a) 50% increase in bone marrow blast count over baseline b) 50% increase in peripheral blast count over baseline - evidence of new EM disease - clinically PD based on the judgment of the investigator. Death in aplasia: Deaths occurring ≥7 days after last administration of the trial drug while cytopenic.|Up to 849 days.|"Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|||Participants|||Number
1339221|NCT01953328|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1337701|NCT01971476|Secondary|The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations|"This outcome measure presents the number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations to assess cardiac activity based on Electrocardiogram (ECG) recordings (digital, triplicate) before and at the end of each Volasertib administration and at least at 2 more time points within the first 24 hours after end of the first Volasertib administration. Two methods of heart rate correction of the QT interval were used: the fixed corrections Fridericia's correction (QTcF) and Bazett's correction (QTcB).~SMQ: Standardised Medical Dictionary for Regulatory Activities (MedDRA) query."|Up to 879 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
1337702|NCT01971476|Secondary|Number of Patients With Clinically Relevant Laboratory Value Changes of Calcium (Hyper- and/or Hypocalcaemia) as Judged by the Investigator and Reported as AEs, CTCAE Grade ≥3|This outcome measure presents number of patients with clinically relevant laboratory value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as AEs, CTCAE Grade ≥3. CTCAE Grade 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|Up to 879 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
1337703|NCT01971476|Secondary|Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)|This outcome measure presents number of patients with hepatic injury defined as AESI. Hepatic injury was defined by the following alterations of liver parameters: an elevation of Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) >3x Upper Limit of Normal (ULN) combined with an elevation of total bilirubin >2x ULN measured in the same blood sample.|Up to 879 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
1337704|NCT01971476|Primary|Maximum Tolerated Dose of Volasertib|This outcome measure presents MTD of Volasertib. The MTD was defined as the highest dose level at which DLTs were reported in not more than 1 in 6 evaluable patients during Cycle 1.|Up to 14 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||mg|||Number
1337705|NCT01971476|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLTs were defined as drug related Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (haematological and nonhaematological) Adverse Events (AEs) with the exception of a) Reduced blood cell count (any grade) without associated clinical complications qualifying for DLT. b) Febrile neutropenia Grade 3. c) Infection Grade 3 with neutrophil count <1000/mm3. d) Uric acid Grade ≥3. e) Nausea, vomiting and/or diarrhoea managed by adequate therapy (i.e. recovery to CTCAE Grade ≤2).|Up to 14 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
1337706|NCT01971385|Secondary|Number of Adverse Events Reported|To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.|8 months|||||||
1337707|NCT01971385|Primary|Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization|Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff|8 months|Because most patients who received 2% SADBE for sensitization did not experience another herpes outbreak and thus did not receive a subsequent treatment dose, we grouped both squaric acid treatment arms together for analysis since both groups had received the same sensitization dose of 2%.|||percentage of particpants|||Number
1337708|NCT01971255|Secondary|Number of Participants With Influenza Symptoms|This was determined by the presence or absence of influenza symptoms.|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||participants|||Number
1337709|NCT01971255|Secondary|Number of Symptoms|A simple count of the number of unique influenza symptoms the participant experienced.|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||Number||Inter-Quartile Range|Median
1337710|NCT01971255|Primary|Number of Patients With Mild to Moderate Influenza Disease (MMID)|This was determined by presence of the combination of symptoms of influenza and presence of a positive clinical test for influenza. If both were present then the participant had positive MMID.|Within 10 days of inoculation|The analysis included only those subjects who received the influenza challenge virus and were not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.) In addition this represents the number of people who were high or low titer at the time of challenge with influenza virus not at screening.|||participants|||Number
1337711|NCT01971255|Secondary|Duration of Symptoms (Days)|The number of days a participant experienced any influenza symptoms|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||Days||Inter-Quartile Range|Median
1337712|NCT01971255|Secondary|Duration of Shedding (Days)|The number of days total from the time a participant had the first positive test for influenza to their last positive test.|Within 14 days of inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||Days||Inter-Quartile Range|Median
1337730|NCT01970995|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||ng/mg creat||95% Confidence Interval|Least Squares Mean
1337713|NCT01971255|Secondary|Clinical Disease Severity Score|This was measured using a validated participant directed questionnaire called FLUPRO. This is then scored daily with a range of score from 0-185. The total score is the sum of all time points the questionnaire is given, which is 16 time points. Therefore the total score range is from 0-2960. 0 would represent no symptoms over the 16 time points while 2960 would represent maximum symptoms and perceived severity at all 16 time points.|Within 28 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||units on a scale||Inter-Quartile Range|Median
1337714|NCT01971203|Primary|MADRS|Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.|baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
1337715|NCT01971203|Secondary|Changes in Sexual Functioning Questionnaire (CSFQ)|Changes in Sexual Functioning Questionnaire (CSFQ) at week 16 as compared to baseline. The CSFQ assesses interest, functioning, and satisfaction in sex on a six-point scale, where 1 is greater than normal and 6 is totally absent, with full range from 5 (greater than normal) to 30 (totally absent).|baseline and week 16||||units on a scale||Standard Deviation|Mean
1337716|NCT01971203|Secondary|Clinical Global Impression Scales for Severity and Improvement|The Clinical Global Impression Scales for Severity and Improvement (CGI-I and CGI-S), both clinician rated, measures overall severity of symptoms and level of improvement on a seven-point scale from 0 (not applicable or not assessed) to 7, where 7 is the most severe. In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).|up to 16 weeks||||units on a scale||Standard Deviation|Mean
1337717|NCT01971203|Secondary|HAM-A|Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety.|baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
1337718|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from TS|||participants|||Number
1337719|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.|The tolerability of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from TS.|||participants|||Number
1337720|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from FAS|||participants|||Number
1337721|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from FAS.|||participants|||Number
1337722|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your sleep? and How did Rhinospray Plus improve the quality of your sleep?."|Up to day 11|Patients from FAS|||participants|||Number
1337723|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your daytime activities?"|up to 11 days|Patients from FAS|||participants|||Number
1337724|NCT01971086|Secondary|The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit|Patients scored the single symptoms (blocked nose, sneezing and running nose) at the end of each treatment day on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The changes in the 3 single scores were calculated by the single score at the final visit minus the single score at baseline. Therefore, a negative change represents an improvement of the single scores.|Baseline and up to day 11|Patients from FAS.|||units on a scale||Full Range|Median
1337725|NCT01971086|Primary|The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep|"The mean score of the following two quality of life improvement questions at the final/closing visit was calculated: How did Rhinospray plus improve the quality of your daytime activities? and How did Rhinospray Plus improve the quality of your sleep?. The scores range from 1=strongly to 4=no improvement. Thus also the range of the mean score is from 1 to 4."|up to day 11|Patients from FAS|||units on a scale||Full Range|Median
1337726|NCT01971086|Primary|The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.|Patients scored the symptoms (blocked nose, sneezing and running nose) on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The range of the mean score thus could be between 0 and 3. The change in the mean of the 3 single scores was calculated by the score at the final visit minus the score at baseline. Therefore, a negative change represents an improvement of the mean score.|Baseline and up to day 11|Patients from the Full Analysis Set (FAS) which includes all patients in the TS who have analysable data in at least one efficacy endpoint.|||units on a scale||Full Range|Median
1337727|NCT01970995|Primary|Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)|"Concentrations measured at Day 90 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|90 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the period Day 60 to Day 90.|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1337728|NCT01970995|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
1337731|NCT01970995|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1337732|NCT01970982|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
1337733|NCT01970982|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1337734|NCT01970982|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||ng/mg creat||95% Confidence Interval|Least Squares Mean
1337735|NCT01970982|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1337736|NCT01970878|Secondary|Change From Baseline in Average Daily Rescue Ventolin Use|Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject’s average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.|Baseline through Week 52|Subjects in the ITT population from the lead-in studies who had data for the parameter|||Puffs per day||95% Confidence Interval|Least Squares Mean
1337737|NCT01970878|Secondary|Change From Baseline in SGRQ Total Score|The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.|Baseline and Weeks 12 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1337738|NCT01970878|Secondary|Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing|Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.|Baseline and Weeks 2 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.|||Liters||95% Confidence Interval|Least Squares Mean
1337739|NCT01970878|Secondary|Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks|SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.|Baseline and Weeks 4 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1337740|NCT01970878|Primary|Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks|Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Baseline and Weeks 2 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.|||Liters||95% Confidence Interval|Least Squares Mean
1337755|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2)|EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|3 years|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
1337741|NCT01970865|Secondary|Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)|This test was performed in the same way as the International Shopping List Test, with the exception that, the delayed recall condition required the participant to recall the words from the list 15 30 minutes later without having the list read again. During the recognition condition, the qualified personnel read a shopping list item that may or may not have been on the original list and the participant had to respond either affirmatively (if the item was on the original list) or negatively (if it was not). Total number of correct responses made in remembering the word list after a delay was recorded. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
1337742|NCT01970865|Secondary|Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)|The International Shopping List task is a measure of verbal learning and uses a well validated list learning paradigm administered using a computer. High frequencies, high imagery, concrete nouns (items from a shopping list) were read to the participant at the rate of one word every 2 seconds. Once all 12 words had been read, the participant was asked to recall as many of the words as quickly as possible. The words recalled by the participant were marked on the computer screen. When the participant could recall no more words, the same list was read again. The words recalled by the participant were recorded. This was then repeated a third time. Total number of correct responses on 3 consecutive trials at a single assessment was recorded. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
1337743|NCT01970865|Secondary|Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)|The One Back Test is a measure of working memory and uses a well validated n back paradigm with playing cards. In this task, the on-screen instructions ask: “Is the previous card the same?”. A playing card is presented in the center of the screen. The participant must decide whether the card is the same as the previous card. If it is the same the participant should press “Yes”, and if not press “No”. The participant is encouraged to work as quickly and accurately as possible. The speed and accuracy of each response are recorded, mean of the log10 transformed reaction times for correct responses is used to demonstrate speed of performance, and the arcsine transformation of the square root of the proportion of correct responses is used to demonstrate accuracy. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
1337744|NCT01970865|Secondary|Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)|The Identification Test is a measure of visual attention and uses a well validated choice reaction time paradigm with playing card stimuli. In this task, the playing cards are all red or black jokers. The on-screen instructions ask: “Is the card red?”. A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as it flips over the participant must decide whether the card is red or not. If it is red the participant should press “Yes”, and if it is not red the participant should press “No”. The participant is encouraged to work as quickly and accurately as possible. The speed and accuracy of each response are recorded and mean of the log10 transformed reaction times for correct responses is calculated. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
1337745|NCT01970865|Secondary|Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)|The Detection Test is a measure of psychomotor function and uses a well validated simple reaction time paradigm with playing card stimuli. In this test, the on-screen instructions ask: “Has the card turned over?”. A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as the card flips over the participant must press “Yes”. The participant is encouraged to work as quickly as they can and be as accurate as possible. The speed and accuracy of each response are recorded and mean of the log10 transformed reaction times for correct responses is calculated. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
1337766|NCT01970865|Secondary|Time for Cmax (Tmax) of PF-06463922 (Phase 2)|Tmax of PF-06463922 was observed directly from data as time of first occurrence.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Full Range|Median
1339222|NCT01953328|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1337746|NCT01970865|Secondary|Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)|The Beck Depression Inventory (BDI)-II is a 21-item self-report scale, with each item rated by participants on a 4-point scale (ranging from 0-3). The scale includes items capturing mood, (loss of pleasure, sadness, and irritability), suicidal ideation, and cognitive signs (punitive thoughts, self-criticism, self-dislike, pessimism, and poor concentration) as well as somatic signs (appetite, sleep, fatigue and libido). Scores were obtained by adding up the total points from the series of answers. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on score||95% Confidence Interval|Least Squares Mean
1337747|NCT01970865|Secondary|Number of Participants With Suicidal Ideation and Suicidal Behavior (Phase 2)|The Columbia Suicide Severity Rating Scale (C-SSRS) was used to analyze participants' suicidal ideation and behavior, and it is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events and provides a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation and deterrents), all of which are significantly predictive of completed suicide.|3 years|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||Participants|||Count of Participants
1337748|NCT01970865|Secondary|Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1 and Phase 2)|Triplicate 12-lead electrocardiograms (ECGs) were performed approximately 2 minutes apart to determine mean QTc interval (QT interval corrected for heart rate). QT interval was corrected for heart rate using Fridericia’s formula to provide QTcF. Absolute values and changes from baseline were summarized according to pre-defined criteria. Baseline was defined as the last evaluation on or prior to the first dose of study treatment.|Phase 1: baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-25, end of treatment (up to 3 years); Phase 2: baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-5, end of treatment (up to 3 years)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
1337749|NCT01970865|Secondary|Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Percent in Left Ventricular Ejection Fraction (LVEF) (Phase 1 and Phase 2)|Left Ventricular Ejection Fraction (LVEF) was determined by electrocardiogram (ECG) measurement. Baseline was defined as the measurement prior to the first dose of study treatment.|Baseline, Day 1 of Cycles 2-3, Day 1 of every other cycle from Cycle 5 up to 18 months for Phase 1 (up to 30 months for Phase 2), every 4 cycles thereafter, and end of treatment (up to 3 years)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
1337750|NCT01970865|Secondary|Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1 and Phase 2)|Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position. Body weight was also measured.|Baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-25 for Phase 1 (Cycles 2-38 for Phase 2), Day 1 of every other cycle thereafter, end of treatment (up to 3 years)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
1337751|NCT01970865|Secondary|Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) – Coagulation, Lipids and Urinalysis|Coagulation evaluation included activated partial thromboplastin time, international normalized ratio (INR), and prothrombin time. Lipid evaluation included total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides. Urinalysis included urine protein and urine blood.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
1337752|NCT01970865|Secondary|Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) – Chemistry|Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus or phosphate, serum total amylase and serum lipase.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
1337753|NCT01970865|Secondary|Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) – Hematology|Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
1337754|NCT01970865|Secondary|Number of Participants With Treatment-Emergent Adverse Events (Phase 1 and Phase 2)|AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
1337767|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2)|Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK concentration analysis set of PF-06463922 included all participants treated who had at least 1 concentration of PF-06463922.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1337756|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2)|European Organisation for Research and Treatment of Cancer Core Quality of Life Questionaires (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhoea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|3 years|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
1337757|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 2)|Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.|Screening|Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).|||Participants|||Count of Participants
1337758|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 2)|Plasma CNA samples were analyzed for ALK kinase domain mutations by Next Generation Sequencing (NGS). Number of participants with one or more ALK mutations is presented.|Screening|CNA peripheral blood analysis set included all participants of the ITT analysis set who had at least 1 molecular biomarker assayed.|||Participants|||Count of Participants
1337759|NCT01970865|Secondary|Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 2)|Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen which was adopted in Phase 2), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
1337760|NCT01970865|Secondary|Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 2)|Rac was calculated as Day 15 AUCtau/Day -7 AUCtau, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen which was adopted in Phase 2).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
1337761|NCT01970865|Secondary|Terminal Half-Life of PF-06463922 (Phase 2)|Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Standard Deviation|Mean
1337762|NCT01970865|Secondary|Apparent Volume of Distribution (Vz/F) of PF-06463922 (Phase 2)|Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liters||Geometric Coefficient of Variation|Geometric Mean
1337763|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of PF-06463922 (Phase 2)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
1337764|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 (Phase 2)|Tau refers to the dosing interval, and it equals to 24 hours for QD dosing which was adopted in Phase 2. AUCtau was determined using linear/log trapezoidal method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1337765|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 (Phase 2)|AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1337768|NCT01970865|Secondary|Overall Survival (Phase 2)|OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
1337769|NCT01970865|Secondary|Progression-Free Survival (PFS) (Phase 2)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective disease progression or to death on study due to any cause, whichever came first. Results presented here were based on independent central review.|3 years|PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
1337770|NCT01970865|Secondary|Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)|The probability of the first event being a CNS progression, a non-CNS progression, or death was evaluated with a competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to the analysis set. The time to first event being a Competing Event (either “CNS progression” or “non CNS progression” or “Death”) was defined as time from first dose until the date of that specific event. Participants not known to have any of the Competing Events were censored on the date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as a competing cause of failure for the analysis of other type of events. For each type of event, the cumulative incidence function corresponding to the nearest time point preceding 1 year is presented. The results are based on independent central review.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||probability|||Number
1337771|NCT01970865|Secondary|Time to Tumor Progression （TTP) and Intracranial TTP (Phase 2)|Time to progression (TTP) was defined as the time from the first dose of study treatment to the first documentation of objective disease progression. Intracranial TTP was defined as the time from the first dose of study treatment to the date of the first documentation of objective progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases. Results presented here were based on independent central review.|3 years|ITT analysis set was used for TTP determination and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; ITT participants with CNS metastases were analyzed for intracranial TTP.|||months||95% Confidence Interval|Median
1337772|NCT01970865|Secondary|Time to Progression (TTP) on the Last Prior Therapy (Phase 2)|TTP on the last prior therapy was defined as time from the first dose date of the last prior treatment regimen to the date of progression.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. As planned, this outcome measure was not analyzed for EXP-1 and EXP-6 groups.|||months||95% Confidence Interval|Median
1337773|NCT01970865|Secondary|Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 2)|Tumor response was evaluated according to RECIST version 1.1, and disease control was defined as confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. Results presented here were based on independent central review.|12 weeks|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
1337774|NCT01970865|Secondary|Duration of Response (DOR) and Intracranial DOR (Phase 2)|Duration of Response (DOR) was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. DOR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial DOR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||95% Confidence Interval|Median
1337775|NCT01970865|Secondary|Time to Tumor Response (TTR) and Intracranial TTR (Phase 2)|Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||Full Range|Median
1337776|NCT01970865|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)|In Phase 1, the MMSE was collected to assess mental status. The MMSE is a 30 item questionnaire that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The MMSE was removed under Amendment 6 of the study protocol, and not required for Phase 2, as the tool was not considered meaningful for assessment of cognitive function.|Baseline, Day 1 of each cycle, and end of treatment (up to 3 years)|MMSE assessment evaluable analysis set included all participants in the safety analysis set (all participants who received at least 1 dose of PF-06463922) who completed a baseline and at least 1 post-baseline assessment.|||units on a score||Standard Deviation|Mean
1337804|NCT01970865|Secondary|Progression-Free Survival (PFS) (Phase 1)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective disease progression or to death on study due to any cause, whichever came first. Results presented here were based on independent central review.|3 years|PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
1337777|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)|EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|Baseline, Day 1 of Cycles 2-25, Day 1 of every other cycle after Cycle 25, end of treatment (up to 3 years)|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
1337778|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)|European Organisation for Research and Treatment of Cancer Core Quality of Life Questionaires (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhoea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|Baseline, Day 1 of Cycles 2-25, Day 1 of every other cycle after Cycle 25, end of treatment (up to 3 years)|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
1337779|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 1)|Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.|Screening|Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).|||Participants|||Count of Participants
1337780|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 1)|Plasma circulating nucleic acid (CNA) samples were analyzed for ALK kinase domain mutations by digital polymerase chain reaction (PCR) BEAMing technology. Number of participants with one or more ALK mutations is presented.|Screening|CNA peripheral blood analysis set included all participants of the ITT analysis set who had at least 1 molecular biomarker assayed.|||Participants|||Count of Participants
1337781|NCT01970865|Secondary|Terminal Half-Life of Midazolam (Phase 1)|Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||hr||Standard Deviation|Mean
1337782|NCT01970865|Secondary|Apparent Volume of Distribution (Vz/F) of Midazolam (Phase 1)|Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||L||Geometric Coefficient of Variation|Geometric Mean
1337783|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of Midazolam (Phase 1)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1337784|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1)|AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1337785|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam (Phase 1)|Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of midazolam was determined using linear/log trapezoidal method. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1337786|NCT01970865|Secondary|Time for Cmax (Tmax) of Midazolam (Phase 1)|Tmax of midazolam was observed directly from data as time of first occurrence. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||hours||Full Range|Median
1337787|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of Midazolam (Phase 1)|Cmax of midazolam was observed directly from data. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflected the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflected the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK concentration analysis set for midazolam included all participants treated with midazolam who had at least 1 concentration of midazolam.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1337788|NCT01970865|Secondary|Percent of PF-06463922 Recovered Unchanged in Urine up to Dosing Interval (AEtau%) (Phase 1)|Dosing interval was 24 hours for QD dosing regimen. Aetau% was calculated as 100*Ae24/dose, where Ae24 was the cumulative amount of drug recovered unchanged in urine up to 24 hours post-dose.|0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. As planned, this parameter was only analyzed for 100 mg QD group.|||percentage of recovered PF-06463922||Standard Deviation|Mean
1337789|NCT01970865|Secondary|Renal Clearance (CLr) of PF-06463922 (Phase 1)|Renal clearance was calculated as Aetau/AUCtau, where Aetau was the cumulative amount of drug recovered unchanged in urine up to dosing interval tau (24 hours for QD dosing regimen), and AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen).|0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. As planned, this parameter was only analyzed for 100 mg QD group.|||ml/hour||Geometric Coefficient of Variation|Geometric Mean
1337790|NCT01970865|Secondary|Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (12 and 24 hours for BID and QD dosing regimen, respectively), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
1337791|NCT01970865|Secondary|Terminal Half-Life of PF-06463922 Following Single Oral Doses (Phase 1)|Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours (hr)||Standard Deviation|Mean
1337792|NCT01970865|Secondary|Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Rac was calculated as Day 15 AUCtau/Day -7 AUCtau or Day 1 AUCtau, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (12 and 24 hours for BID and QD dosing regimen, respectively).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
1337793|NCT01970865|Secondary|Apparent Volume of Distribution (Vz/F) of PF-06463922 Following Single Oral Doses (Phase 1)|Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1338099|NCT01966770|Primary|Overall Ease of Lens Handling (Day 1 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy|Day 1 - After Removal||||units on a scale||Standard Deviation|Mean
1337794|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1337795|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of PF-06463922 Following Single Oral Doses (Phase 1)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1337796|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 Following Single Oral Doses (Phase 1)|AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1337797|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1337798|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Single Oral Doses (Phase 1)|Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, and 24 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1337799|NCT01970865|Secondary|Time for Cmax (Tmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Tmax of PF-06463922 was observed directly from data as time of first occurrence.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Full Range|Median
1337800|NCT01970865|Secondary|Time for Cmax (Tmax) of PF-06463922 Following Single Oral Doses (Phase 1)|Tmax of PF-06463922 was observed directly from data as time of first occurrence.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Full Range|Median
1337801|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 was observed directly from data.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).|PK concentration analysis set for PF-06463922 included all participants treated who had at least 1 concentration of PF-06463922.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1337802|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Single Oral Doses (Phase 1)|Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK concentration analysis set for PF-06463922 included all participants treated who had at least 1 concentration of PF-06463922.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1337803|NCT01970865|Secondary|Overall Survival (OS) (Phase 1)|OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
1337943|NCT01968980|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1337805|NCT01970865|Secondary|Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1)|The probability of the first event being a CNS progression, a non-CNS progression, or death was evaluated with a competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to the analysis set. The time to first event being a Competing Event (either “CNS progression” or “non CNS progression” or “Death”) was defined as time from first dose until the date of that specific event. Participants not known to have any of the Competing Events were censored on the date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as a competing cause of failure for the analysis of other type of events. For each type of event, the cumulative incidence function corresponding to the nearest time point preceding 1 year is presented. The results are based on independent central review.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||probability|||Number
1337806|NCT01970865|Secondary|Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 1)|Tumor response was evaluated according to RECIST version 1.1, and disease control was defined as confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. Results presented here were based on independent central review.|12 weeks|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
1337807|NCT01970865|Secondary|Duration of Response (DOR) and Intracranial DOR (Phase 1)|Duration of Response (DOR) was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. DOR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial DOR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||95% Confidence Interval|Median
1337808|NCT01970865|Secondary|Time to Tumor Response (TTR) and Intracranial TTR (Phase 1)|Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||Full Range|Median
1337809|NCT01970865|Secondary|Percentage of Participants With Overall and Intracranial Objective Response (Phase 1)|Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. Results presented here were based on independent central review.|3 years|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
1337810|NCT01970865|Primary|Percentage of Participants With Overall and Intracranial Objective Response (Phase 2)|Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. Results presented here were based on independent central review.|3 years|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with central nervous system (CNS) metastases in the ITT analysis set were used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
1337811|NCT01970865|Primary|Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1|DLT was defined as any of the following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for >7 days; febrile neutropenia; grade >=3 neutropenic infection; grade >=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade >=3 pancreatitis; grade >=3 toxicities (excluding grade >=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade >=3 QTc prolongation, or asymptomatic grade >=3 prolongation that had been confirmed by repeat testing and re-evaluation by a qualified person, and persisted after correction of reversible causes; >=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of the 21 prescribed daily total doses due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicities attributable to study drug.|Cycle 1 (21 days)|Maximum Tolerated Dose (MTD) evaluable population included all enrolled participants who received at least 75% of the planned PF-06463922 doses in Cycle 1. Participants who received less than 75% of the planned PF-06463922 doses in Cycle 1 due to DLT were also considered evaluable for MTD.|||Participants|||Count of Participants
1337812|NCT01970787|Secondary|Progression of HSIL to Cancer|Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.|12 months|||||||
1337813|NCT01970787|Secondary|Adverse Events|Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.|12 months||||participants|||Number
1337944|NCT01968980|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1337814|NCT01970787|Secondary|Tolerability|"Subject tolerability of the RFA procedure as measured by severity. Mild: Awareness of signs and symptoms, but easily tolerated; are of a minor irritant type; causing no loss of time from normal activities; symptoms would not require medication or a medical intervention; asymptomatic lab findings; marginal clinical relevance; signs and symptoms are transient.~Moderate: Discomfort severe enough to cause interference with usual activities; minimal intervention.~Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may be of systemic nature or require medical evaluation or treatment."|12 months||||participants|||Number
1337815|NCT01970787|Secondary|Feasibility and Ease of Technique|"Technical feasibility of applying RFA to the anal canal. Physician's assessment of ablation as optimal (complete ablation) versus sub-optimal (incomplete ablation)in the affected area in the anal canal.~Data not collected and could not be analyzed"|12 months|||||||
1337816|NCT01970787|Primary|Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)|Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment|12 months||||participants w histological clearance|||Number
1337817|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 50|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.|||percentage of participants|||Number
1337818|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 32|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of participants|||Number
1337819|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 16|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
1337820|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 50|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.|||percentage of participants|||Number
1337821|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 32|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of participants|||Number
1337822|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 16|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
1337823|NCT01970488|Secondary|Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).~Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.|Results are reported for the anti-drug antibody analysis set (defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable antibody test) from Baseline to Week 16 for all randomized participants, and from baseline to Week 52 for participants who were re-randomized.|||percentage of participants|||Number
1337834|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 32|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 32|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 32 are included.|||percentage of participants|||Number
1337824|NCT01970488|Secondary|Number of Participants With Adverse Events|"The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.~A serious AE is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups."|From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.|The safety analysis set includes all randomized participants who received at least 1 dose of study drug, based on actual treatment received.|||participants|||Number
1337825|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from Baseline (negative value) indicates improvement."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data|||percentage of BSA||Standard Deviation|Mean
1337826|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from Baseline (negative value) indicates improvement."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of BSA||Standard Deviation|Mean
1337827|NCT01970488|Secondary|Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16|"A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from baseline (negative value) indicates improvement."|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of BSA||Standard Deviation|Mean
1337828|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 50|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 50|This analysis was performed in the re-randomized analysis set with available data.|||percentage of participants|||Number
1337829|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 32|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of participants|||Number
1337830|NCT01970488|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) Response at Week 16|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
1337831|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 50|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline is calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data|||percent change||Standard Deviation|Mean
1337832|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 32|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline is calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data|||percent change||Standard Deviation|Mean
1337833|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 50|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 50|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 50 are included.|||percentage of participants|||Number
1337871|NCT01969565|Secondary|Overall Response Rate (ORR), Defined as sCR, CR, Very Good Partial Response (VGPR), and PR at 4 Cycles|The ORR will be estimated based on the crude proportion of subjects for whom best overall response is sCR, CR, VGPR, and PR.|4 months|Patient withdrew consent before receiving treatment||||||
1337835|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 16|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
1337836|NCT01970488|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline was calculated as (value at baseline – value at post-baseline visit) × 100 / (value at baseline)."|Baseline and Week 16|This analysis was performed using the full analysis set which includes all participants initially randomized in the study. Last observation carried forward (LOCF) imputation was used for participants with at least one post-baseline value.|||percent change||Standard Deviation|Mean
1337837|NCT01970475|Secondary|Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).~Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|Up to week 26|Participants with at least 1 evaluable antibody test result (to either ABP 501 or adalimumab)|||percentage of participants|||Number
1337838|NCT01970475|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:~1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question “is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product” was yes.~A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening (places the subject at immediate risk of death)~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.|The safety analysis set (all participants who received at least 1 dose of study drug)|||participants|||Number
1337839|NCT01970475|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and Week 24|Full analysis set with available data at week 24|||percentage of participants|||Number
1337840|NCT01970475|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and week 24|Full analysis set with available data at week 24|||percentage of participants|||Number
1337841|NCT01970475|Secondary|Percentage of Participants With an ACR20 Response at Week 2 and Week 8|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline, week 2 and week 8|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value (indicated by n).|||percentage of participants|||Number
1337842|NCT01970475|Secondary|Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).~The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity.~A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed."|Baseline and weeks 2, 4, 8, 12, 18, and 24|Full analysis set with available data at each time point|||units on a scale||Standard Deviation|Least Squares Mean
1337872|NCT01969565|Primary|Patients With ≥ VGPR (Very Good Partial Response)|VGPR will be estimated based on the crude proportion of subjects whose best response is Stringent Complete Response (sCR), Complete Response (CR), and VGPR.|4 months-8 months|Patient withdrew consent before receiving treatment||||||
1337843|NCT01970475|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and Week 24|The full analysis set (all randomized participants); missing values were imputed using the last observation carried forward (LOCF) method for participants with at least 1 postbaseline value.|||percentage of participants|||Number
1337844|NCT01970462|Other Pre-specified|Hypoglycemia|Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks.|6 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. There was no hypoglycemia reported in any of the 5 subjects for whom data were available at the 6 week timepoint.||||||
1337845|NCT01970462|Other Pre-specified|Adherence|adherence defined as 80% of all Sitagliptin doses respectively taken in previous week|6 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. Among the 5 subjects for whom data were available, 100% were adherent.||||||
1337846|NCT01970462|Other Pre-specified|Self Monitored Blood Glucose|Mean blood glucose at week 2|2 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. Among the 5 subjects for whom data were available the value was 130, 134.6, 96.5, 132, 98 mg/dl||||||
1337847|NCT01970462|Primary|Difference in Fasting Glucose|Difference in mean fasting glucose at 6 weeks post-discharge.|6 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. Therefore we are unable to provide group level data for the outcomes. Among the 4 subjects for whom data was available, the fasting 6 week glucose value was 158, 114, 83, 237 mg/dl.||||||
1337848|NCT01970397|Secondary|Subject's Global Assessment of Change in Appearance of Perioral Lines|The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.|Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available at the given time-point.|||units on a scale||95% Confidence Interval|Mean
1337849|NCT01970397|Secondary|Participant Assessed Procedural and Post-Procedural Pain Levels|The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.|During injection, immediately following injection, 15, 30, and 45 min post-injection|Intent-to-treat population included all randomized and treated participants.|||units on a scale||95% Confidence Interval|Mean
1337850|NCT01970397|Primary|Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The investigator evaluated the severity of the participant’s upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.|Baseline, Month 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available for analysis at Month 6.|||percentage of participants|||Number
1337851|NCT01969799|Secondary|Clinical Relapse Rate|Clinical relapse rates (defined as a new episode of pneumonia requiring reinstitution of IV antibiotics) from Day 11 through Day 28|Day 11 - Day 28|MITT|||participants|||Number
1337852|NCT01969799|Secondary|Mortality From Day 1 Through Day 28|Mortality from Day 1 through Day 28, all causes, does not reflect just infection only|Day 1 - Day 28|MITT|||participants|||Number
1337853|NCT01969799|Secondary|Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria|Microbiological response rates at Day 14 in patients whose pre-study treatment bronchoalveolar lavage (BAL) was positive for multi-drug resistant Gram-negative bacteria. Response is defined as not have a positive tracheal aspirate culture on Day 14|Day 14|patients with MDR bacteria at baseline BAL|||Participants|||Count of Participants
1337854|NCT01969799|Secondary|Number of ICU Days From Day 1 Through Day 28||Day 1 - Day 28|MITT|||Days||Standard Deviation|Mean
1337855|NCT01969799|Secondary|Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28|Number of days free of mechanical ventilation from Day 1 through Day 28 mean days.|Day 1 - Day 28|MITT|||Days ± SD||Standard Deviation|Mean
1337856|NCT01969799|Secondary|Composite Endpoint of Mortality and Ventilator-free Days|The hierarchical composite endpoint of mortality, then ventilator-free days. The table reflects winners of matched pairs, ties are not noted.|Day 1- Day 28|MITT|||participants|||Number
1337857|NCT01969799|Secondary|Composite Endpoint of Mortality and Clinical Cure|The hierarchical composite endpoint of mortality, then clinical cure (defined as both absence of Gram-negative bacteria and CPIS at Day 14 < 6). The tables reflect a winner of matched pairs, ties are not noted.|Day 1 - Day 28|MITT|||participants|||Number
1337858|NCT01969799|Primary|Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .|Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.|10 day treatment period.|MITT|||units on a scale||Standard Error|Least Squares Mean
1337890|NCT01969435|Secondary|Disease-free Survival|Percentage of patients who survive without any signs or symptoms of cancer at 1 year.|1 year||||percentage of participants||95% Confidence Interval|Number
1337859|NCT01969747|Primary|Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo|"Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo.~The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model.~The primary endpoint is exploratory."|baseline (Day -1) and 7 days after first drug administration (Day 7)|"Full analysis set (FAS): all patients randomised, treated with at least one dose of study drug, had a baseline UGE (g/24 h) and a UGE (g/24 h) on Day 1 or Day 7.~The last observation carried forward (LOCF) approach was used as the primary method of imputation for missing data."|||g/24h||Standard Error|Mean
1337860|NCT01969721|Secondary|FEV1 Peak (0−3h) Change From Patient Baseline After 6 Weeks of Treatment|Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
1337861|NCT01969721|Secondary|FEV1 AUC (12−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
1337862|NCT01969721|Secondary|Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
1337863|NCT01969721|Secondary|FEV1 AUC (0−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.~Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
1337864|NCT01969721|Primary|FEV1 AUC (0−12h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
1337865|NCT01969708|Secondary|Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces|The measure is the number of study eyes with central subfield thickness <300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6|Month 0 to 6|All participants with central subfield thickness recorded at Month 6|||study eyes|||Number
1337866|NCT01969708|Secondary|Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6|The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness|Month 0 to 6|All participants with central subfield thickness recorded at baseline and Month 6|||um||95% Confidence Interval|Mean
1337867|NCT01969708|Secondary|Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness|The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography|Month 0 to 6|All participants with central subfield thickness recorded at baseline and Month 6|||um||95% Confidence Interval|Mean
1337868|NCT01969708|Secondary|Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6|The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6|Month 0 to 6|All participants with visual acuity letter score recorded at Month 6|||study eyes|||Number
1337869|NCT01969708|Secondary|Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6|The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6|Month 0 to 6|All participants with visual acuity letter score recorded at Month 6|||study eyes|||Number
1337870|NCT01969708|Primary|Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6|The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.|Month 0 to 6|All participants with visual acuity letter score recorded at Month 6|||letters read||95% Confidence Interval|Mean
1337873|NCT01969565|Primary|Tolerability and Safety of Increasing Doses of Carfilzomib in Combination With Dexamethasone.|Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) adverse event dictionary. The results will be tabulated to examine their frequency, organ systems affected, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly.|24 months|Patient withdrew consent before receiving treatment||||||
1337874|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Albuterol|"Pre-dose subtracted maximum measured concentration (Cmax) of albuterol.~Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set|||ng/ml||Standard Deviation|Mean
1337875|NCT01969539|Secondary|Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol|"Area under the concentration-time curve over the time interval from 0 to 6 hour (AUC 0-6) of ipratropium and albuterol.~This secondary endpoint was not calculated due to a carry-over effect."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set||||||
1337876|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Ipratropium|"Pre-dose subtracted maximum measured concentration (Cmax) of ipratropium.~Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set|||pg/ml||Standard Deviation|Mean
1337877|NCT01969448|Secondary|Breast Weight||At time of surgery (day 1)||||grams||Standard Deviation|Mean
1337878|NCT01969448|Secondary|Mean Operative Times for Mastectomy||At the time of surgery (day 1)||||minutes||Standard Deviation|Mean
1337879|NCT01969448|Secondary|Number of Participants With Tissue Expander||Up to 3 months post permanent implant placement||||Participants|||Count of Participants
1337880|NCT01969448|Secondary|Breast Q Score|-The BREAST-Q is a previously validated instrument which measures patient reported outcomes. It has several iterations including the one utilized here which is specific for implant-based breast reconstruction. Each of its 6 domains generates a Q-score from 0 (lowest) to 100 (highest). A higher number indicates a higher satisfaction or better quality of life than a lower number. Based on answers to the questions, each individual will generate a whole number score for each domain. The patient can be sampled preoperatively and postoperatively as well as over time to calculate the impact of intervention and time on this value. Q-scores are calculated for each domain, and the investigators report a mean value based on data from an entire cohort for the particular domain. Domains include evaluation of overall satisfaction with breasts, physical well being, sexual well being, as well as satisfaction with office staff, information provided, and the provider.|Up to 3 months post permanent implant placement|6 participants were not evaluable for this outcome measure in the inframammary fold incision cohort and 2 particpants were not evaluable for this outcome measure in the lateral radial incision cohort due to not completing the Breast Q score.|||units on a scale||Standard Deviation|Mean
1337881|NCT01969448|Primary|Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction|"Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion.~The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds)."|At the time of surgery (day 1)||||percentage of original preop perfusion|||Number
1337882|NCT01969448|Primary|Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy|"Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion.~The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds)."|At the time of surgery (day 1)||||percentage of original preop perfusion|||Number
1337883|NCT01969435|Post-Hoc|Overall Survival (OS) Rate||Median follow-up 15.4 months (range 4.7-24.6)||||percentage of participants|||Number
1337884|NCT01969435|Post-Hoc|Relapse Free Survival||1 year||||percentage of participants|||Number
1337885|NCT01969435|Post-Hoc|Progression-free Survival Rate (PFS)||1 year||||percentage of participants||95% Confidence Interval|Median
1337886|NCT01969435|Post-Hoc|Progression-free Survival (PFS) Rate|PFS - Time from start of treatment to the time of progression or death, whichever occurs first.|6 months||||percentage of participants||95% Confidence Interval|Median
1337887|NCT01969435|Secondary|Time to Engraftment (Platelet)|Time from the date of transplant to the date of platelet engraftment.|Assessed up to day 100|One patient did not have platelet engraftment by Day 100|||days||Full Range|Median
1337888|NCT01969435|Secondary|Time to Engraftment (Neutrophil)|Time from the date of the transplant to the date of neutrophil engraftment.|Assessed up to day 30||||days||Full Range|Median
1337889|NCT01969435|Secondary|Disease-free Survival|Percentage of patients who survive without any signs or symptoms of cancer at 2 years.|2 years||||percentage of participants|||Number
1337893|NCT01969435|Primary|Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events|Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.|Day -7 through Day 30||||participants|||Number
1337894|NCT01969240|Secondary|Physician Trust|The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.|Immediately after the visit (day 1)||||units on a scale||Standard Deviation|Mean
1337895|NCT01969240|Secondary|Decisional Conflict|Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.|Immediately after the visit (day 1)||||units on a scale||Standard Deviation|Mean
1337896|NCT01969240|Secondary|Total Testing Within 45 Days (a Component of Healthcare Utilization)|In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.|45 days||||number of tests obtained||Standard Deviation|Mean
1337897|NCT01969240|Secondary|Major Adverse Cardiac Event (MACE)|A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.|within 30 days of enrollment||||participants|||Number
1337898|NCT01969240|Secondary|Test if the Decision Aid Safely Improves Patient Engagement.|1) Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.|Immediately after the intervention (on day 1)||||units on a scale||Standard Deviation|Mean
1337899|NCT01969240|Secondary|Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.|We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.|Within 30 days of study enrollment||||participants|||Number
1337900|NCT01969240|Primary|Test if Chest Pain Choice Safely Improves Patient Knowledge.|Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.|Directly following intervention (on day 1)||||number of questions correct||Standard Deviation|Mean
1337901|NCT01969162|Primary|Tear Lipid Composition Profile|Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).|Day 1|A subset of enrolled participants who had non-stimulated (basal) tear samples.|||pmole||Standard Deviation|Mean
1337902|NCT01969084|Secondary|Changes in Circulating Endothelial Progenitor Cell Phenotypes|The measurements of the various EPC phenotypes were performed at the Beth Israel Deaconess Flow Cytometry Core Facility. Immunofluorescent cell staining was performed on peripheral blood with the use of the fluorescent conjugated antibodies. 1.000.000 events per sample were acquired using a FACS LSR II analyzer (Becton Dickinson, Franklin Lakes, NJ, USA) and the results were analyzed using the Beckman Coulter Kaluza analysis software (Beckman Coulter Inc., Brea, CA, USA).|Baseline and 12 weeks||||Events per million||Inter-Quartile Range|Median
1337903|NCT01969084|Secondary|Changes in SDF1-α and Substance P||Baseline and 12 weeks||||pg/ml||Inter-Quartile Range|Median
1337904|NCT01969084|Secondary|Changes in Vascular Reactivity in the Micro- and Macro-circulation.|Change in markers of macro- and microvascular function from the baseline visit to the post-treatment visit between the two groups.|Baseline and 12 weeks||||percent change||Inter-Quartile Range|Median
1337905|NCT01969084|Secondary|Change in Muscle Oxygenation Recovery Time|Change in muscle oxygenation after ischemia inducing occlusion for 4 minutes.|Baseline and 12 weeks||||seconds||Inter-Quartile Range|Median
1337906|NCT01969084|Primary|Phosphocreatine (PCR) Recovery Time After Exhaustive or up to 6 Minutes of Leg Exercise.|Change in the time to phosphocreatine recovery between the baseline visit and post-treatment visit following the graded exercise test.|Baseline and 12 weeks||||seconds||Inter-Quartile Range|Median
1337907|NCT01969058|Secondary|Primary Targeted Adverse Events|Targeted events for A5325 include: events that meet the International Conference on Harmonization (ICH) definitions for a serious adverse event, post-entry signs/symptoms and laboratory abnormalities of Grade ≥3 or that lead to a change in treatment regardless of grade, and any diagnoses.|from study entry to end of study (week 28)|all enrolled participants|||Participants|||Count of Participants
1337908|NCT01969058|Secondary|Pharmacokinetics – Trough Concentrations of Isotretinoin and Antiviral Treatment (ART)|"Isotretinoin arm only, trough concentrations of isotretinoin at weeks 8, 12, 16, and trough concentrations of ART at study entry and weeks 8, 12, 16, 20 and 24.~Pharmacokinetics data are not available as of November 2017. To minimize variability, pharmacokinetics assays were batched. Due to batching, sample shipment could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Given that this was a multi-center study, shipment of samples took several months to complete. Therefore, samples are in the process of being tested. Upon completion of the testing, the results will be reviewed for data completeness and quality. After resolution of any issues and finalization of the database, the analysis can be conducted and the results will then be posted to ClinicalTrials.gov."|study entry, weeks 8, 12, 16, 20 and 24||2018-11-30|11/2018||||
1337945|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1339223|NCT01953328|Secondary|Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1337909|NCT01969058|Secondary|Change in Endogenous Retinoid Metabolite Profiles|"Change in endogenous retinoid metabolite profiles from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.~Data for endogenous retinoid metabolite profiles is not available as of November 2017. Pharmacokinetics assays were batched to minimize variability. Sample shipment could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Given that this was a multi-center study, shipment of samples took several months to complete. Upon completion of the testing, the results will be reviewed for data completeness and quality. After resolution of any issues and finalization of the database, the analysis can be conducted and the results will then be posted to ClinicalTrials.gov."|baseline, week 14/16, week 28||2018-11-30|11/2018||||
1337910|NCT01969058|Secondary|Change in Th17 Frequency|"Th17 (T-helper 17) cells are a subset of pro-inflammatory T helper cells defined by their production of interleukin 17 (IL-17).~The outcome is the change in Th17 frequency from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.~Th17 data are not available as of May 2018. These data are based on immunology assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary complete date. Please note that these secondary outcomes are not included in the primary analyses. There are many outcomes in this study and the lab had to give priority to the assays planned to be included in the primary manuscript"|baseline, week 14/16, week 28||2018-11-30|11/2018||||
1337911|NCT01969058|Secondary|Change in Treg Frequency|"Treg (T Regulatory) Cells are a subpopulation of T cells which modulate the immune system.~The outcome measure is the change in Treg frequency from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.~Data for Treg frequency are not available as of May 2018. These data are based on immunology assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary complete date. Please note that these secondary outcomes are not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript."|baseline, week 14/16, week 28||2018-11-30|11/2018||||
1337912|NCT01969058|Secondary|Cell-associated HIV-1 DNA|"Cell-associated HIV-1 DNA in blood at baseline, week 14/16, and week 28. Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.~For cell-associated HIV-1 DNA results below the assay limit, the lowest value of the sample was imputed to these results and considered lowest ranks (1.62 log10 copies/10^6 CD4 cells).~It was originally planned to summarize the absolute changes for cell-associated HIV-1 DNA. However, since there are many results below limit of detection, analyzing the absolute changes would be inappropriate in this case.~Instead, the baseline, week 14/16, and week 28 levels were summarized."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16~have cell-associated HIV-1 DNA data"|||log10 copies/million CD4 cells||Inter-Quartile Range|Median
1337913|NCT01969058|Secondary|Change in Cell-associated HIV-1 RNA|"Cell-associated HIV-1 RNA in blood from baseline to week 14/16(week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.~For cell-associated HIV-1 RNA results below the assay limit, the lowest value of the sample was imputed to these results (1.32 log10 copies/10^6 CD4 cells).~Since there are only a few results below the assay limit, it is still reasonable to summarize the absolute changes for cell-associated HIV-1 RNA, where changes were calculated based on the imputed values (described above) for below assay limit results."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16~have cell-associated HIV-1 RNA data"|||log10 copies/million CD4 cells||Inter-Quartile Range|Median
1337914|NCT01969058|Secondary|Change in CD4+ T-cell Count|"Change in peripheral total CD4 cell count from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||cells/mm^3||Inter-Quartile Range|Median
1337915|NCT01969058|Secondary|Change in sCD163|"sCD163 (soluble CD 163) is a marker of macrophage activation Change in log10 transformed sCD163 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 ng/mL||Inter-Quartile Range|Median
1337946|NCT01968980|Secondary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1343116|NCT01903863|Secondary|Red Blood Cell Transfusion|Compared red blood cell transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)||||ml/kilogram/ECMO day||Inter-Quartile Range|Median
1337916|NCT01969058|Secondary|Change in TF|"TF (Tissue Factor) is a marker of Coagulation. Change in log10 transformed TF from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
1337917|NCT01969058|Secondary|Change in D-dimer|"D-dimer (or D dimer) is a marker of coagulation activation. Change in log10 transformed D-dimer from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 ng/mL||Inter-Quartile Range|Median
1337918|NCT01969058|Secondary|Change in sTNF-r2|"sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a marker of inflammation. Change in log10 transformed sTNF-r2 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
1337919|NCT01969058|Secondary|Change in sTNF-r1|"sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a marker of inflammation. Change in log10 transformed sTNF-r1 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
1337920|NCT01969058|Secondary|Change in hsCRP|"hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation. Change in log10 transformed hsCRP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 ng/mL||Inter-Quartile Range|Median
1337921|NCT01969058|Secondary|Change in IL-6|"IL-6 (Interleukin-6) is a marker of systemic inflammation. The outcome measures are changes in log10 transformed IL-6 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
1337922|NCT01969058|Secondary|Change in I-FABP|"I-FABP (intestinal-fatty acid binding protein) is a marker of intestinal cell damage and turnover.~The outcome measures are changes in log10 transformed I-FABP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
1337923|NCT01969058|Secondary|Change in sCD14|"sCD14 (soluble cluster of differentiation 14) is a marker of gut microbial translocation and monocyte activation.~The outcome measures are changes in log10 transformed sCD14 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
1337924|NCT01969058|Secondary|Change in CD8+ T-cell Activation|"Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.~The endpoint is measuring the change from week 14/16 to week 28 (week 28 - week 14/16) and from baseline to week 28 (week 28 - baseline).~Baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||percentage of cells||Inter-Quartile Range|Median
1339224|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1337925|NCT01969058|Primary|Change in CD8+ T-cell Activation From Baseline to Week 14/16|"Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+. The endpoint is measuring the change from baseline to week 14/16, where baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16.~Change = (week 14/16 - baseline)."|baseline, week 14/16|"The primary analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||percentage of cells||Inter-Quartile Range|Median
1337926|NCT01968980|Secondary|Percentage of Participants With Positive Anti­Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive.|Baseline up to the end of study (up to 58 weeks)|Analysis was performed on all participants who received at least 1 dose of PF-04950615.|||percentage of participants|||Number
1337927|NCT01968980|Secondary|Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.|Baseline up to the end of study (up to 58 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1337928|NCT01968980|Secondary|Plasma PF-04950615 Concentrations at Week 12, 24 and 52||Week 12, 24, 52|Analysis was performed on all participants who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||microgram per milliliter||Standard Deviation|Mean
1337929|NCT01968980|Secondary|Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants|||Number
1337930|NCT01968980|Secondary|Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants|||Number
1337931|NCT01968980|Secondary|Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||ratio||Standard Deviation|Mean
1337932|NCT01968980|Secondary|Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||ratio||Standard Deviation|Mean
1337933|NCT01968980|Secondary|Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1337934|NCT01968980|Secondary|Absolute Change From Baseline in Lipoprotein (a) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1337935|NCT01968980|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1337936|NCT01968980|Secondary|Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1337937|NCT01968980|Secondary|Absolute Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1337938|NCT01968980|Secondary|Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1337939|NCT01968980|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1337940|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1339225|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1337947|NCT01968980|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1337948|NCT01968980|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1337949|NCT01968980|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1337950|NCT01968980|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1337951|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1337952|NCT01968980|Secondary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1337953|NCT01968980|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1337954|NCT01968980|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1337955|NCT01968967|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.|Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110|"All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, n signifies number of participants who were evaluable at specified time points."|||Percentage of participants|||Number
1337956|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period||Baseline, Week 58 follow-up visit, 71, 84, 97, 110|"All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period). Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337957|NCT01968967|Secondary|Number of Participants Who Changed Concomitant Medication During Extension Period|In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.|Week 58 follow-up visit to Week 110|All participants who consented for extension period.|||Participants|||Count of Participants
1337958|NCT01968967|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.|Baseline up to Week 58|"Safety analysis population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure for each reporting arm respectively."|||Percentage of participants|||Number
1337959|NCT01968967|Secondary|Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to Week 58|Safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1337960|NCT01968967|Secondary|Plasma Concentration of PF-04950615 at Week 12, 24 and 52|Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.|Week 12, 24, 52|"Analysis set included participants who received at least 1 dose of PF-04950615. Here, n signifies those participants who were evaluable at specified time points."|||Microgram per milliliter||Standard Deviation|Mean
1337961|NCT01968967|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
1337962|NCT01968967|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
1337963|NCT01968967|Secondary|Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants evaluable at specified time points."|||Ratio||Standard Deviation|Mean
1337964|NCT01968967|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||Ratio||Standard Deviation|Mean
1337965|NCT01968967|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337966|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337967|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337968|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337969|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337970|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337971|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337972|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
1337973|NCT01968967|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337974|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337975|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337976|NCT01968967|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337977|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, “N” signifies number of participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
1337978|NCT01968967|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337979|NCT01968967|Secondary|Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1337980|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337981|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1337982|NCT01968967|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1343117|NCT01903863|Secondary|Plasma Free Hemoglobin|Compare plasma free hemoglobin levels between control and treatment group|ECMO course (median 198 hours)||||mg/dL||Inter-Quartile Range|Median
1337983|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1337984|NCT01968967|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
1337985|NCT01968967|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, Number of participants analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1337986|NCT01968954|Other Pre-specified|Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1337987|NCT01968954|Other Pre-specified|Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1337988|NCT01968954|Other Pre-specified|Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1337989|NCT01968954|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.|Baseline up to the end of study (up to 58 weeks)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of PF-04950615 were evaluable for this outcome measure. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1337990|NCT01968954|Secondary|Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to the end of study (up to 58 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
1337991|NCT01968954|Secondary|Plasma PF-04950615 Concentrations at Week 12, 24 and 52||Week 12, 24, 52|Analysis set included participants who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||microgram per milliliter||Standard Deviation|Mean
1337992|NCT01968954|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52||Week 12, 24 and 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
1337993|NCT01968954|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52||Week 12, 24 and 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
1337994|NCT01968954|Secondary|Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||ratio||Standard Deviation|Mean
1337995|NCT01968954|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||ratio||Standard Deviation|Mean
1337996|NCT01968954|Secondary|Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1337997|NCT01968954|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1337998|NCT01968954|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1337999|NCT01968954|Secondary|Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1338000|NCT01968954|Secondary|Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1338001|NCT01968954|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1338002|NCT01968954|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off|Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.|Baseline, Week 12|FAS included all participants who were randomized.‘Number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
1338003|NCT01968954|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338004|NCT01968954|Secondary|Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338005|NCT01968954|Secondary|Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338006|NCT01968954|Secondary|Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338007|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off|Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.|Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338008|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338009|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia|Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.|Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1338010|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia|Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.|Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1338011|NCT01968954|Secondary|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338012|NCT01968954|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338013|NCT01968954|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338014|NCT01968954|Secondary|Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338015|NCT01968954|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
1338016|NCT01968954|Primary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1338036|NCT01968213|Primary|Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)|Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).|Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years.|Intent-to-treat: All patients randomized|||Months||95% Confidence Interval|Median
1338017|NCT01968811|Primary|To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings|"Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0~Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0"|From 1 to 3 visit, depending on each subject/wound, up to 4 days.|10 patients were enrolled and individually analysed and presented in the study|||number of surgeons|||Number
1338018|NCT01968811|Secondary|- Fascial/Skin Closure of the Open Abdomen|The performance objective is assessed through general application and removal questions after each investigational device handling.|End of treatment, up to 4 days.|No. Analysed for efficacy ITT 10 , PP 9,|||participants|||Number
1338019|NCT01968694|Secondary|Change in Hospital Anxiety and Depression Scale (HADS)|"The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale.~A score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case).~Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:~(1 day post-treatment value - BL pre-infusion value)~(1 week post-treatment value - BL pre-infusion value)~(1 month post-treatment value - BL pre-infusion value)"|1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)|In the IV diphenhydramine arm 1 pt is missing HADS scores at 1 week, and 3 pts are missing scores at 1 month. In the IV Lidocaine arm 3 pts are missing HADS scores at 1 month.|||units on a scale||Inter-Quartile Range|Median
1338020|NCT01968694|Secondary|Change in Brief Pain Inventory (BPI): Pain on Average|"The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine.~Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:~(1 day post-treatment value - BL pre-infusion value)~(1 week post-treatment value - BL pre-infusion value)~(1 month post-treatment value - BL pre-infusion value)"|1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)|In the IV diphenhydramine arm 1 pt is missing BPI avg pain score at 1 week, and 2 are missing scores at 1 month. In the IV Lidocaine arm 1 pt is missing a score at 1 day, 1 is missing a score at 1 week, and 4 are missing scores at 1 month.|||units on a scale||Inter-Quartile Range|Median
1338021|NCT01968694|Secondary|Change in Short Form McGill Pain Questionnaire 2|"Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220.~Change scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment:~(30 minutes post-treatment value - BL pre-infusion value)~(1 week post-treatment value - BL pre-infusion value)~(1 month post-treatment value - BL pre-infusion value)"|30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)|"participant in the IV diphenhydramine arm is missing SFMPQ total score 1 week post-treatment.~participants in the IV diphenhydramine arm are missing SFMPQ total score 1 month post-treatment.~participants in the IV Lidocaine arm are missing SFMPQ total score 1 month post-treatment."|||units on a scale||Inter-Quartile Range|Median
1338022|NCT01968694|Primary|Change in Visual Analogue Scale (VAS)|"Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain).~Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete:~(15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)"|15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)|"2 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion started.~3 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion complete."|||units on a scale||Inter-Quartile Range|Median
1338023|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.|||cells/μL||Standard Deviation|Mean
1338024|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.|||cells/μL||Standard Deviation|Mean
1338025|NCT01968551|Secondary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study.|||percentage of participants|||Number
1338026|NCT01968551|Primary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set (FAS) in Cohort 2, included all participants who (1) were randomized to Cohort 2 and (2) received at least 1 dose of study drug during the open-label Phase.|||percentage of participants|||Number
1338027|NCT01968434|Secondary|Change in Day Cough Score at End of Study (From D0 to D4)|"A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every day of the trial is rated. The last evening of the study (D4) the parents rated the passed day by scoring from 0-6 each of the 3 aspects of day cough. The summed score for all aspects gives the combined day cough score. This score, ranging between 0-18, was subtracted from the sum of all aspects, also ranging between 0-18, form the basal day cough score of the day before enrollment (D0). This change is recorded as change in combined day cough score and it refers to the change from D0 to D4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study. 6 patients from the protective syrup group and twelve 11 patients from the carbocysteine group did not answer the questions for the last day.|||change in combined day cough score||Standard Error|Mean
1338028|NCT01968434|Secondary|Change in Night Cough Score at End of Study (From N0 to N4)|"A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the passed night. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every night of the trial is rated. The morning after the last night of the study (N4) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The summed score for all aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study. 7 patients from the protective syrup group and twelve 12 patients from the carbocysteine group did not answer the questions for the last night.|||change in combined night cough score||Standard Error|Mean
1338029|NCT01968434|Primary|Change in Night Cough Score on First Night of Treatment (From N0 to N1)|"Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient."|1 night from before enrollment (N0) to first night after treatment (N1)|the population analyzed are the children who completed the protocol and submitted the complete questionnaire for night and day cough. 78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study.|||change in combined night cough score||Standard Error|Mean
1338030|NCT01968226|Primary|Target to Background Ratio (TBR)|To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy.|Baseline|no subject analysis done||||||
1338031|NCT01968213|Secondary|Individual Model Parameter Estimates of Rucaparib and Covariates Identification|Concentration summary statistics|Study data collection expected to last for ~7 months.|All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1338032|NCT01968213|Secondary|Overall Survival (OS)|The final OS analysis has not been performed yet and will be performed when 70% of the events have been collected.|Continuously for ~5 years after patient enrolls into study.||2021-01-31|01/2021||||
1338033|NCT01968213|Secondary|Time to an 8-point Decrease in the Total Score of the FOSI-18|The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy|Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.|||||||
1338034|NCT01968213|Secondary|Time to a 4-point Decrease in the Disease-related Symptoms – Physical (DRS-P) Subscale of the FOSI-18|The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.|Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.|||||||
1338035|NCT01968213|Secondary|Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)|To evaluate PFS by RECIST, as assessed by independent radiology review (IRR)|Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years.|Intent-to-treat: All patients randomized|||months||95% Confidence Interval|Median
1338041|NCT01968057|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
1338042|NCT01968057|Primary|PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1338043|NCT01968057|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1338044|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Percentage at Week 48||Baseline; Week 48|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1338045|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Percentage at Week 24||Baseline; Week 24|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1338046|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
1338047|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
1338048|NCT01967940|Secondary|Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48||Baseline; Week 48|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1338049|NCT01967940|Secondary|Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24||Baseline; Week 24|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1338050|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Part 2 Full Analysis Set|||percentage of participants|||Number
1338051|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Part 2 Full Analysis Set|||percentage of participants|||Number
1338052|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Part 2 Full Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.|||percentage of participants|||Number
1338053|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Part 2 Full Analysis Set|||percentage of participants|||Number
1338054|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48||Up to Week 48|Part 2 Safety Analysis Set|||percentage of participants|||Number
1338055|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24||Up to Week 24|Part 2 Safety Analysis Set|||percentage of participants|||Number
1338056|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48||Up to Week 48|Part 2 Safety Analysis Set|||percentage of participants|||Number
1338057|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24||Up to Week 24|Part 2 Safety Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.|||percentage of participants|||Number
1338058|NCT01967940|Secondary|Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10||Baseline; Day 10|Part 1 Full Analysis Set|||log10 copies/mL||Standard Deviation|Mean
1338059|NCT01967940|Primary|Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10||Day 10|Part 1 Full Analysis Set: participants who enrolled into Part 1 of the study and received at least one dose of study drug in Part 1.|||percentage of participants|||Number
1338100|NCT01966770|Primary|Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion||||percentage of investigators|||Number
1338060|NCT01967836|Secondary|Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit|"The secondary outcomes of the study are clinic nurse observed problems. Percentage of yes responses of nurse observations of site at clinic visit~Line dressing intact (Yes) is in place (reporting on 20 lines on 28 RN observations)~Absence (No) of local skin irritation,~Dislodgement of the IV line/needle (No) with the IV site upon subject return to the clinic and verification by the subject ."|Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days|Nurse questionnaire evaluation forms were completed relative to subjects questionnaires being returned at next clinic visit|||percentage of observation|Nurse Observation of IV Site||Number
1338061|NCT01967836|Primary|Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports.|0 Not at all satisfied 10 Very satisfied|Reported afer each subject showering survey completion||||units on a scale||Standard Deviation|Mean
1338062|NCT01967836|Primary|Patient Subject Questionnaire Post Shower Evaluation|"Percentage of responses to evaluation questions (Percentage reported are yes responses) for the following questions. 40 surveys were returned from 11 patient subjects.~Did you need assistance to place the Glad Press 'n Seal to your IV area?~Was the area covered by the Glad Press 'n Seal dry after taking it off?~Was the dressing covering your IV undamaged after taking off the Glad Press 'n Seal?~Did you feel the IV Line was accidentally pulled at all with the use of the Glad Press 'n Seal?~Likert Scale response to the following question On a scale of 0 (would not use) to 10 (would continue to use) how satisfied were you in using Glad Press n Seal?"|complete one evaluation after each shower when using product|10 oncology and 1 ambulatory subjects returned 39 evaluation forms for primary analysis|||percentage of yes responses|||Number
1338063|NCT01967784|Primary|Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine|Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set.|||Percentage of participants|||Number
1338064|NCT01967784|Primary|Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set.|||Titers ratio||95% Confidence Interval|Geometric Mean
1338065|NCT01967784|Primary|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.|Day 21 post-vaccination|Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
1338066|NCT01967784|Primary|Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was analyzed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
1338067|NCT01967784|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were analyzed in the Immunogenicity Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1338068|NCT01967732|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1338069|NCT01967732|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
1338070|NCT01967719|Primary|Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1338293|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
1338071|NCT01967719|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares (geometric LS) means are provided."|3 days|Pharmacokinetics (PK) populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
1338072|NCT01967706|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng*h/mL||95% Confidence Interval|Least Squares Mean
1338073|NCT01967706|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
1338074|NCT01967641|Secondary|Pain Measurement|The primary pain measure was the Pain Assessment and Documentation Tool (PADT). Total score ranging from 0-11 reported. Higher score considered indicative of more pain. Lower score is indicative of less pain.|assessed twice weekly during course of 19 weeks or length of participation, only screening and last assessment reported.||||units on a scale||Standard Deviation|Mean
1338075|NCT01967641|Secondary|Number of Participants Abstinent From Opioids|Relapse was number of participants with opioid-negative urine toxicology in last week of study participation.|at week 19 or length of study participation||||participants|||Number
1338076|NCT01967641|Primary|Number of Participants Retained in Study|Retention was number of participants retained at study end (Week 19).|week 19||||participants|||Number
1338077|NCT01967628|Primary|Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)|We investigated the effect of vitamin D3 supplementation on airway surface liquid antimicrobial activity using a bioluminescent bacterial challenge. We challenged airway surface liquid samples with bioluminescent bacteria and measured live bacteria by relative light units (RLU) after 2 minutes as a surrogate of antimicrobial activity. We interpreted a reduction in live bacteria after challenge in relative light units as increased antimicrobial activity|3 months||||Relative Light Units (RLU)||95% Confidence Interval|Mean
1338078|NCT01967550|Primary|Measure: Pain On Movement (POM)|POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.|2 weeks|The modified ITT (mITT) population excludes subjects in the ITT population who were incorrectly instructed by the investigator to treat only one knee. The mITT population is primary for the analysis of efficacy.|||units on a scale||Standard Deviation|Mean
1338079|NCT01967342|Secondary|Patient Global Impression of Change (PGIC), Pain Intensity|"The Patient Global Impression of Change (PGIC) assesses self-perceived changes in pain intensity. Scores were dichotomized such that responses of very much better and much better were recoded as 1 and all other responses were coded as zero, as performed by Cherkin et al. (2016), in order to indicate clinically meaningful improvement on pain intensity. The following outcome measure data table reports the number of participants per group reporting clinically meaningful improvement at post-treatment (10-weeks) and follow-up (6-months)."|Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).|Only participants who completed the post-treatment (10-weeks) and follow-up (6-months) assessments were included in the following analyses.|||Participants|||Count of Participants
1338080|NCT01967342|Secondary|Patient Health Questionnaire - 9 (PHQ-9)|Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.|||units on a scale||Standard Deviation|Mean
1338081|NCT01967342|Secondary|Brief Pain Inventory-Interference (BPI-Interference)|Brief Pain Inventory-Intensity indicates level of pain interference. Higher scores (range 0-10) reflect higher perceived pain interference.|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.|||units on a scale||Standard Deviation|Mean
1338082|NCT01967342|Primary|Brief Pain Inventory-Intensity (BPI-Intensity)|Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.|||units on a scale||Standard Deviation|Mean
1338083|NCT01967277|Primary|Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks||||terminal hairs||Standard Deviation|Mean
1338084|NCT01967277|Primary|Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks||||percent change||Standard Deviation|Mean
1338294|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
1338085|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
1338086|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
1338087|NCT01967147|Secondary|Change From Baseline in OSDI Score at Day 35|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
1338088|NCT01967147|Secondary|Change From Baseline in TOSS Score at Day 35|The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
1338089|NCT01967147|Primary|Change From Baseline in TFBUT at Day 35|TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||seconds||Standard Error|Mean
1338090|NCT01967121|Primary|Pain Scores on the Visual Analog Scale|Visual Analog Scale for Muscle Soreness scale The scale for measuring the intensity of muscle soreness will be a 10 cm visual analog scale, spaced by one centimeter increments from one to 10. Ten will represent the maximum amount of soreness and zero represents no soreness at all. Subjects will be asked to complete this scale once per day at the same time of day until the soreness has dissipated. The Visual Analog Scale for muscle soreness is measured as 'scores on a scale'.|Day 1 through Day 5||||scores on a scale||Standard Deviation|Mean
1338091|NCT01967069|Primary|Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)|IGA of clear or almost clear|Day 15|Intent to Treat|||percentage of subjects||95% Confidence Interval|Number
1338092|NCT01966926|Secondary|Changes in Perceptions of Weight Tracking|Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study. The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking. A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|three to six months||||units on a scale||Standard Deviation|Mean
1338093|NCT01966926|Secondary|Changes in Barriers to Weight Tracking|Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study. The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing. A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
1338094|NCT01966926|Secondary|Changes in Body Image|Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire. The subscale has a range of 0 to 42, with higher scores indicating better body image. A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
1338095|NCT01966926|Secondary|Changes in Anxiety|Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA. Possible scores on the scale range from 0-63. Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
1338096|NCT01966926|Secondary|Changes in Depression Ratings|Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA). Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms. Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
1338097|NCT01966926|Primary|Adherence to Weight Tracking Instructions|Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).|6 months|All participants were included in the analysis.|||percentage of postcards returned|||Number
1338101|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion||||percentage of investigators|||Number
1338102|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion||||percentage of investigators|||Number
1338103|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1 - 30 minutes||||percentage of investigators|Participants||Number
1338104|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes||||percentage of investigators|Participants||Number
1338105|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes||||percentage of investigators|Participants||Number
1338106|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)|Day 2 - 30 minutes||||millimeters|Participants|Standard Deviation|Mean
1338107|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 2 - 30 minutes||||percentage|Participants|Standard Deviation|Mean
1338108|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 2 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 2 - 30 minutes||||percentage of lenses|Participants||Number
1338109|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)|Day 1 - 30 minutes||||millimeter|Participants|Standard Deviation|Mean
1338110|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 1 - 30 minutes||||percentage|Participants|Standard Deviation|Mean
1338111|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 1 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 1 - 30 minutes||||percentage of lenses|Participants||Number
1338112|NCT01966770|Primary|Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)|Baseline||||millimeters|Participants|Standard Deviation|Mean
1338113|NCT01966770|Primary|Lens Fitting Characteristics, Tightness (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Baseline||||percentage|Participants|Standard Deviation|Mean
1338114|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Habitual Lens)|Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Baseline||||percentage of eyes|Participants||Number
1338115|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes||||percentage of participants|||Number
1338116|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes||||percentage of participants|||Number
1338117|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - 30 minutes||||percentage of participants|||Number
1338118|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion||||percentage of participants|||Number
1338119|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion||||percentage of participants|||Number
1338120|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion||||percentage of participants|||Number
1338121|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes||||percentage of participants|||Number
1338122|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes||||percentage of participants|||Number
1338123|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes||||percentage of participants|||Number
1338124|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion||||percentage of participants|||Number
1338125|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 Insertion||||percentage of participants|||Number
1338126|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion||||percentage of participants|||Number
1338127|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever|Day 2 - 30 minutes||||units on a scale||Standard Deviation|Mean
1338128|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever|Day 2 - Insertion||||units on a scale||Standard Deviation|Mean
1338129|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)|Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - 30 minutes||||units on a scale||Standard Deviation|Mean
1338130|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 1 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - Insertion||||units on a scale||Standard Deviation|Mean
1338131|NCT01966770|Primary|Visual Acuity (VA) logMAR (Study Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)|Dispense||||LogMAR||Standard Deviation|Mean
1338132|NCT01966770|Primary|Visual Acuity (VA) logMAR (Habitual Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)|Baseline||||LogMar||Standard Deviation|Mean
1338133|NCT01966718|Secondary|Change From Baseline in the C-Reactive Protein (CRP) Level|CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.|From baseline to week 16||||mg/dL||Full Range|Mean
1338134|NCT01966718|Secondary|Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)|ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased|From baseline to week 16||||mm/hr||Full Range|Mean
1338150|NCT01966354|Secondary|Number of Cannulation Attempts|Number of cannulation attempts that have taken place before cannulation success. Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)||||attempts||Standard Deviation|Mean
1338135|NCT01966718|Primary|Change From Baseline in the 20-item Health Assessment Questionnaire Score|"Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from able to do with no difficulties to unable to do. A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16."|From baseline to week 16||||units on a scale||Full Range|Mean
1338136|NCT01966718|Primary|Change From Baseline in the Ritchey-Camp Articular Index|Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.|From baseline to week 16||||joints|Participants|Full Range|Mean
1338137|NCT01966458|Secondary|Number of Participants With Stroke-Free Success|Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale >=4).|Implant to 12 Months|Subjects were excluded if they had no associated 24 week post-stroke Modified Rankin Scale value, or if the subject withdrew or was lost to follow-up on original device, and no other failure outcome occurred within 1 year post original implant.|||Participants|||Count of Participants
1338138|NCT01966458|Secondary|Number of HeartWare VAS Participants With Stroke/TIA|The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.|Implant to 12 Months|Subjects were excluded if they withdrew or were lost to follow up on the original device.|||Participants|||Count of Participants
1338139|NCT01966458|Primary|Number of Participants With Neurologic Injury|The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) > 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.|Implant to 12 Months|Subjects were excluded if they withdrew, were lost to follow-up or have missing outcomes on original device.|||Participants|||Count of Participants
1338140|NCT01966432|Primary|Treatment for Drug Use or Alcohol|Percentage of patients who received substance abuse or alcohol treatment (self reported)|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||percentage of participants||95% Confidence Interval|Number
1338141|NCT01966432|Primary|Percentage of Participants Who Reported Substance Use at 6 Month|For SBI and SBIRT groups: Proportion of baseline substance users (SBI, SBIRT) who continue substance use during the study (self reported) For S group: Proportion of baseline non-users (S) who report substance use during follow-up visit|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||percentage of participants||95% Confidence Interval|Number
1338142|NCT01966432|Primary|Alcohol Use Status|Results of AUDIT-C survey. The AUDIT-C is a 3-item alcohol screen that can help identify people who are hazardous drinkers or have active alcohol use disorders. AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the person’s drinking is affecting his/her safety|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||units on a scale||95% Confidence Interval|Mean
1338143|NCT01966432|Primary|Cigarette Smoking Status and Nicotine Dependence|Results from Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||units on a scale||95% Confidence Interval|Mean
1338144|NCT01966432|Primary|Drug Use Status and Frequency|Results of DAST-10 survey to determine use of illicit or nonmedical drugs.The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool that assesses drug use, not including alcohol or tobacco use, in the past 12 months. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. DAST-10 scores on a 10-point scale. A score of 0 indicates no problems and 10 indicates a severe level of problems are associated with drug abuse.|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||units on a scale||95% Confidence Interval|Mean
1338145|NCT01966380|Primary|Absorption of Wound Exudates.|Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT|2-3 weeks|Participants served as their own controll, those the total amount of participants is reflekted in both of the outcome measurements.|||Total no. assess. in each wounddressing|Participants||Number
1338146|NCT01966354|Secondary|Infectious Complications|The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn. Patients will be followed for the duration of central venous access, an expected average of 8 weeks. The number of patients with bacterial colonization and catheter-related blood stream infection will be registered.|Once the central venous catheter is withdrawn (2 months)||||participants|||Number
1338147|NCT01966354|Secondary|Mechanical Complications|The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement. This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed.|At the end of the cannulation process (180 seconds, maximum)||||participants|||Number
1338148|NCT01966354|Secondary|Cannulation Time|Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein. This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)||||seconds||Standard Deviation|Mean
1338149|NCT01966354|Secondary|First Attempt Cannulation|"Any cannulation that has been accomplished with a single cannulation attempt will be considered a first attempt cannulation. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)||||participants|||Number
1338151|NCT01966354|Primary|Cannulation Success|"Cannulation will be considered as successful once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered unsuccessful. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)||||participants|||Number
1338152|NCT01966159|Other Pre-specified|Target Lesion Failure (TLF) Rate|Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non–Q-wave) related to the target vessel, or (cardiac) death.|12 months post-index procedure||||percentage of participants|||Number
1338153|NCT01966159|Secondary|Target Lesion Revascularization (TLR) Rate|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months post-index procedure||||percentage of participants|||Number
1338154|NCT01966159|Primary|The In-stent Late Loss Measured by Quantitative Coronary Angiography||at 9 months post-index procedure.||||mm||Standard Deviation|Mean
1338155|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last PDT (PP)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Per Protocol Set (PP)|||percentage of participants||95% Confidence Interval|Number
1338156|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from “very good” (0) to “impaired” (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
1338157|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from “very good” (0) to “impaired” (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
1338158|NCT01966120|Secondary|Change of Total Lesion Area 12 Weeks After Last PDT|The fifth key secondary efficacy variable in the hierarchic test procedure was the change from baseline in the total lesion area per patient assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of lesion area change||Standard Deviation|Mean
1338159|NCT01966120|Secondary|Patient Partial Response 12 Weeks After Last PDT|The fourth key secondary efficacy variable in the hierarchic test procedure was the patient partial response (defined as complete clearance of at least 75% of treated AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
1338160|NCT01966120|Secondary|Lesion Complete Response 12 Weeks After Last PDT|The third key secondary efficacy variable in the hierarchic test procedure was the lesion complete response (completely cleared individual AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of lesions|Number of Lesions Analyzed|95% Confidence Interval|Number
1338161|NCT01966120|Secondary|Patient Complete Response 12 Weeks After PDT 1|The second key secondary efficacy variable in the hierarchic test procedure was the patient complete response (complete clearance of all treated AK lesions) assessed at 12 weeks after PDT 1.|12 weeks after PDT 1|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
1338204|NCT01965756|Secondary|Trails-B|Standard Trails-B assessment, in which subject is asked to begin at Number 1 and draw a line to Letter A, then to Number 2, then to Letter B, then so forth until he/she reaches the END, without lifting their pencil. They should draw the line as fast as possible, and are timed (in seconds).|16 weeks- measured at baseline, week 8 (crossover), and week 16||||Seconds||Standard Deviation|Mean
1338162|NCT01966120|Secondary|Patient Histopathological Confirmed Response Rate|"For the secondary confirmatory analysis, several superiority hypotheses were tested within a pre-defined hierarchic multiple testing procedure as described in the Statistical Analysis Protocoll (SAP).~The key secondary efficacy variables were tested strictly in a pre-defined order to ensure the family-wise error rate (FWER) and the testing procedure had to be stopped once the first non-significant test was obtained.~The results of the confirmatory analysis are presented in the order pre-defined by the confirmatory testing procedure.~Assessments of the patient histopathological confirmed response (HCR) rates were based on the results from the biopsy taken 12 weeks after the last PDT from a representative AK lesion selected at screening. If the biopsy result for a patient revealed a residual AK, the patient was considered “not cleared” for the analysis irrespectively of the investigator’s clinical assessment."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS) 6 patients (1 BF-200 ALA and 5 Placebo patients) had a missing evaluation of the second biopsy 12 weeks after PDT.|||percentage of participants||95% Confidence Interval|Number
1338163|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
1338164|NCT01966068|Primary|Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use|Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.|Up to 6 Months|Analysis population included every subject (parent/guardian) who logged on to the MyAsthma Web Portal at least once.|||participants|||Number
1338165|NCT01966042|Secondary|Functional Change Evaluation|Analysis of objective improvement in myocardial ischemia (in %), by stress technetium scintigraphy.|Baseline, 6 and 12 months||||percentage of area change||Standard Deviation|Median
1338166|NCT01966042|Other Pre-specified|Life Quality|"Analysis of the variation in life quality questionnaire - Short Form Health Survey (SF-36) was performed. Each domain of the questionnaire was evaluated as a quantitative variable and the medians were retrieved before and after the procedure.~The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.~It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.~One patient was lost before answering the questionnaire post procedure."|Baseline and 12 months||||units on a scale||Standard Deviation|Median
1338167|NCT01966042|Secondary|Functional Change Evaluation|Analysis of Left Ventricular Ejection Fraction (in %), by echocardiogram.|Baseline and 12 months||||percentage of Left Ventrical Ejection||Standard Deviation|Median
1338168|NCT01966042|Primary|Angina Class Variation|"It was evaluated in accordance with the percentage of participants that change the functional class of angina according to CCSAC (Canadian Cardiovascular Society Angina Classification - description below), after treatment. The functional class of angina was also analyzed as an ordinal variable and the median of the functional class was calculated before and after the procedure, at the time of interest (3, 6 and 12 months post treatment), in comparison to baseline, ie. value at 3 months minus value at baseline.~Screening of Functional Graduation of Stable Angina:~I - Angina only occurs after a fast or prolonged and strenuous effort during work or recreation.~II - Slight limitation to everyday activities. III - Considerable limitation of common physical activity. IV - Inability to perform any physical activity without discomfort, the symptoms can be present at rest."|3, 6 and 12 months||||Angina Classification||Standard Deviation|Median
1338169|NCT01966003|Secondary|Overall Survival|"Overall survival (OS) was defined as the time from the randomization date to date of death. Participants alive at the end of study were censored at the last date known to be alive, derived from dates collected within the study that implied a participant was alive.~Participants were followed for survival status during the treatment phase and thereafter every 9 weeks until the end of the clinical study, consent was withdrawn, they were lost to follow-up, died, or had proscribed therapy (eg, commercial bevacizumab, non-study anti-cancer treatment)."|From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Safety analysis population|||months||95% Confidence Interval|Median
1338170|NCT01966003|Secondary|Number of Participants Who Developed Anti-drug Antibodies|Two validated assays were used to detect the presence of anti-ABP 215 antibodies. Samples were first tested in an electrochemiluminescence (ECL)- based bridging immunoassay to detect antibodies capable of binding to ABP 215 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based target binding assay to determine neutralizing activity against ABP 215 (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.|44 weeks (6 months after end of treatment)|Safety analysis population with available data|||participants|||Number
1338205|NCT01965756|Primary|Word List Memory Total - ADAS-cog|Alzheimer's Disease Assessment Scale- Cognitive Sub scale (ADAS-COG). Three trials of 10 words each (30 words total)|16 weeks (total) - measured at baseline, week 8 (crossover), and week 16||||Words recalled||Standard Deviation|Mean
1338171|NCT01966003|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4, and according to the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death due to AE.~A serious adverse event (SAE) is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event"|up to 19 weeks|Safety analysis population consisted of all participants who received any amount of study drug.|||participants|||Number
1338172|NCT01966003|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1 based on the central, independent, blinded radiologists’ review, or death. Participants who were alive and did not meet the criteria for progression by the end of the study were censored at their last evaluable disease assessment date. Participants with no evaluable tumor assessments after randomization who did not die by the end of the study were censored on the randomization date.~Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions."|From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
1338173|NCT01966003|Secondary|Duration of Response|"Duration of response (DOR) was calculated as the time from the first objective response (PR or CR) to disease progression per RECIST v1.1 based on the central, independent, blinded radiologists’ review.~DOR was only calculated for participants with an objective response. For responders not meeting the criterion for progression by the end of the study, DOR was censored at the date of the last evaluable tumor assessment.~Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions."|Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population with an objective response|||months||95% Confidence Interval|Median
1338174|NCT01966003|Primary|Percentage of Participants With an Objective Response|"Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders.~CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to < 10 mm.~PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions."|Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population which consisted of all randomized participants.|||percentage of participants|||Number
1338175|NCT01965938|Secondary|Alternate Device Used||<100 seconds||||number times an alternate device used|||Number
1338176|NCT01965938|Other Pre-specified|Oropharyngeal Injuries|Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.|24 hours||||participants|||Number
1338177|NCT01965938|Secondary|Lowest Pulse Oximetry Saturation Value Reading During Intubation|Lowest pulse oximetry saturation value reading collected from any participant during intubation|<100 seconds||||percentage of saturated hemoglobin|||Number
1338178|NCT01965938|Secondary|Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist|Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc|<100 seconds||||participants|||Number
1338179|NCT01965938|Secondary|Grade of Glottic View|According to McCormack and Lehane|<100 seconds|data was not collected||||||
1338180|NCT01965938|Secondary|Number of Attempts Performed During Airway Management||<100 seconds||||number attempts||Standard Deviation|Mean
1338181|NCT01965938|Secondary|Number of Participants With Successful Intubation|Successful intubation defined as confirming tube placement by the presence of etCO2;|<100 seconds||||participants|||Number
1338182|NCT01965938|Primary|Time Until Proper Endotracheal Tube Placement|Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.|usually <100 seconds||||seconds||Inter-Quartile Range|Median
1338183|NCT01965899|Secondary|Survey of the Patient Experience Over Time|"To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device over 1 month, 6 month, and 12 month follow-up visit."|12 months|"There were 149 patient surveys from 150 1-month follow-up visits collected, 145 surveys from 147 6-month visits, and 143 surveys from 144 12-month visits. Thus, 437 surveys were collected from 441 follow-up visits. The question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device was answered 434 times."|||Percentage of surveys|Participants||Number
1338184|NCT01965899|Secondary|Survey of the Implanting Physicians|"To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question Overall, how would you rate the ease of entire implant procedure?."|Day of implant|"There have been 151 implant procedures in the study, and 151 physician implant surveys were collected. Of these 151 surveys, 149 answered the question Overall, how would you rate the ease of entire implant procedure?."|||Percentage of surveys|||Number
1338185|NCT01965899|Secondary|Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor|To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive.|48 hours|A Holter recording was performed in all 150 patients (one patient exited before 1 month), of which 141 were suitable for analysis after excluding recordings with technical issues, such as loss of telemetry or inability to process the data.|||Percentage of patients|||Number
1338186|NCT01965899|Secondary|Safety Endpoint|To characterize the system-related and procedure-related adverse events.|12 months||||Number of events|||Number
1338187|NCT01965899|Secondary|Accuracy of Reveal LINQ Device Detected Atrial Fibrillation|To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.|4 months||||Episodes|Participants||Number
1338188|NCT01965899|Primary|R-wave Amplitudes Greater Than or Equal to 200 μV|The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.|||Percentage of subjects|||Number
1338189|NCT01965899|Primary|R-wave Amplitude|To characterize the signal quality of the R-wave amplitude at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.|||μV||Standard Deviation|Mean
1338190|NCT01965899|Primary|Success of Wireless Transmissions|To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.|30 days|All 151 subjects received a CareLink monitor software update. Subjects contributed 4,511 follow-up days in their first 30 days.|||percentage of successful transmissions|Participants|95% Confidence Interval|Number
1338191|NCT01965834|Secondary|Proportion of Participants Achieving Progression-Free Survival|Proportion of participants achieving progression-free survival. Measured from date of initiation of treatment (Day 1) to the earliest occurrence of any of the following events: documented disease progression, or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status.|6 months, 12 months||||participants|||Number
1338192|NCT01965834|Secondary|Number of Subjects Experiencing Adverse Events|To evaluate safety and tolerability of fenofibrate therapy in patients with multiple myeloma.|Up to 8 months||||participants|||Number
1338193|NCT01965834|Primary|Rate of Response in Participants Receiving Fenofibrate Therapy|To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.|After two cycles, about 2 months|No participants achieved response to protocol therapy (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), or Partial Response (PR)). Two (2) patients had stable disease (SD); one (1) patient achieved Stable Disease/clinical Progressive Disease, and three (3) patients had progressive disease (PD).|||participants|||Number
1338194|NCT01965782|Secondary|Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma||One hour post-dose up to 72 hours post dose|No drug was given or data collected due to the study being terminated.||||||
1338195|NCT01965782|Secondary|Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
1338196|NCT01965782|Secondary|Pharmacokinetics of LY3023703 and Radioactivity Area Under The Concentration-Time Curve From Time Zero to the Last Timepoint With a Measurable Concentration [AUC (0 to Tlast)]||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
1338197|NCT01965782|Secondary|Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax)||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
1338198|NCT01965782|Secondary|Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax)||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
1338199|NCT01965782|Primary|Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
1338200|NCT01965782|Primary|Fecal Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
1338201|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Phosphorylated Tau Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET|||pg/mL||Standard Deviation|Mean
1338202|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Total Tau Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET|||pg/mL||Standard Deviation|Mean
1338203|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Amyloid Beta Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET|||pg/mL||Standard Deviation|Mean
1338209|NCT01965652|Secondary|Participant Global Satisfaction|"Participants were asked to rate their degree of satisfaction of constipation and abdominal symptoms from the start of study drug dosing to Week 52 (or early termination).~Satisfaction was rated based on the following seven grades:~Grade 1 = markedly worsened~Grade 2 = moderately worsened~Grade 3 = slightly worsened~Grade 4 = unchanged~Grade 5 = slightly improved~Grade 6 = moderately improved~Grade 7 = markedly improved"|Week 52 or early termination visit|Intent-to-treat population|||percentage of participants|||Number
1338210|NCT01965652|Secondary|Change From Baseline in the Satisfaction Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The satisfaction domain consists of 5 questions related to participants’ feelings of satisfaction with their bowel function. The satisfaction domain score was calculated as the mean of the 5 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1338211|NCT01965652|Secondary|Change From Baseline in the Worries and Concerns Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The worries and concerns domain consists of 11 questions related to participants’ feelings and concerns about their constipation. The worries and concerns domain score was calculated as the mean of the 11 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1338212|NCT01965652|Secondary|Change From Baseline in the Psychosocial Discomfort Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The psychosocial discomfort domain consists of 8 questions related to participants’ embarrassment regarding their constipation and effects of constipation on eating habits and appetite.~The psychosocial discomfort score was calculated as the mean of the 8 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1338213|NCT01965652|Secondary|Change From Baseline in the Physical Discomfort Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The physical discomfort domain consists of 4 questions related to bloating, feeling heavy, how much of the time participants felt any physical discomfort and how much time they felt the need to open their bowel but were not able to. The physical discomfort score was calculated as the mean of the 4 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1338214|NCT01965652|Secondary|Change From Baseline in the Patient Assessment of Constipation Quality of Life Overall Score|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants’ daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The overall score was calculated as the mean of all 28 item scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat|||units on a scale||Standard Error|Least Squares Mean
1338215|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Stool-symptoms Domain Score|"The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The stool-symptom domain score was calculated as the mean of the following 5 items: incomplete bowel movements, bowel movements that were too hard, bowel movements that were too small, straining or squeezing to try to pass bowel movements, and false-alarm bowel movements.~A negative change from baseline value indicates improvement in symptoms."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1338216|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Rectal-symptoms Domain Score|The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 3 items: painful bowel movements, rectal burning during or after a bowel movement, and rectal bleeding or tearing during or after a bowel movement. A negative change from baseline value indicates improvement in symptoms.|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1338217|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Abdominal-symptoms Domain Score|"The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 4 items: abdominal discomfort, abdominal pain, abdominal bloating and stomach cramps.~A negative change from baseline value indicates improvement in symptoms."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1338271|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338218|NCT01965652|Secondary|Change From Baseline in the Overall Score for Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The overall score was calculated as the mean of all 12 items and ranges from 0 (best) to 4 (worst). A negative change from baseline value indicates improvement.|Baseline and Weeks 2, 12, 24, 36, and 52|The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.|||units on a scale||Standard Error|Least Squares Mean
1338219|NCT01965652|Secondary|Percentage of Participants Meeting Each Criterion of Laxative Use|"Participants who were taking stable routine/regular laxatives at Screening were to continue taking the same regimen throughout the study.~The percentage of participants meeting each of the criteria below are reported:~1. Participants not on stable laxatives, defined as participants who did not use laxatives from 28 days prior to the Screening Period to the final dose of study drug or who received only rescue laxative. Rescue is defined as any laxative taken for the first time during the Treatment Period.~1a. Out of participants who were not on stable laxatives, participants who received rescue laxatives.~2. Participants on stable laxatives, defined as participants who may have had at least one/any stable laxative use reported from 28 days prior to Screening Period to the final dose of study drug.~2a. Out of participants who were on stable laxatives, participants who received rescue laxatives.~3. Participants who did not meet criteria 1 or 2."|From 28 days prior to screening until the end of the treatment period (total of 56 weeks)|Intent-to-treat population|||percentage of participants|||Number
1338220|NCT01965652|Secondary|Change From Baseline in the Number of Bowel Movements Per Week|Participants monitored their bowel movements and completed a daily bowel habits diary the week prior to study visits (i.e. during Weeks 11, 23, 35, and 51).|Baseline and Weeks 12, 24, 36, and 52|The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.|||bowel movements / week||Standard Error|Least Squares Mean
1338221|NCT01965652|Primary|Number of Participants With Adverse Events|"A serious adverse event was defined as any adverse event (AE) that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization were considered an SAE when, based upon appropriate medical judgment, they jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Adverse drug reactions (ADRs) were defined as adverse events that were considered by the investigator to be definitely, probably, or possibly related to study drug. Serious ADRs were defined as serious AEs considered by the investigator to be definitely, probably, or possibly related to study drug."|From the first dose of study drug up to 14 days after the last dose of study drug (54 weeks).|Safety population|||participants|||Number
1338222|NCT01965600|Secondary|Time to Cmax (Tmax) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.||||||
1338223|NCT01965600|Secondary|Area Under the Concentration-time Profile From Time 0 to End of Dosing Interval, Tau (AUCtau) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.||||||
1338224|NCT01965600|Secondary|Maximum Plasma Concentration (Cmax) of PF-06282999||Day 3|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
1338225|NCT01965600|Secondary|Peak (AUC0.5-2hours and AUC0-2hours) of MPO Activity/MPO Mass|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
1338226|NCT01965600|Secondary|Concentrations of TNF-alpha, IL-1 Beta, IL-6, IL-8, and hsCRP|The effect of multiple oral doses of PF-06282999 on inflammatory biomarkers was a secondary objective in this study. The biomarkers are tumor necrosis factor (TNF)-alpha, interleukin (IL)-1 beta, IL-6, IL-8, and high-sensitivity C-reactive protein (hsCRP).|Days 1, 3, and 4|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
1338227|NCT01965600|Primary|Number of Participants With Abnormal Urinary Biomarker Values|Urinary biomarkers included albumin, neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin-C.|Days 1-3 prior to dosing with PF-06282999/Placebo; and Days 4-5|Analysis not done due to early termination of study.||||||
1338228|NCT01965600|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the ECG Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval >=500 msec; QT corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec, and >=500 msec, or an increase of 30 to <60 msec or >=60 msec. Due to early termination of the study, only ECG data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening; Days 1-5 and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.|||participants|||Number
1338251|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.|||percentage of participants|||Number
1338229|NCT01965600|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change (increase [inc] or decrease [dec]) in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change (inc or dec) in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate (PR) of <40 or more than (>)120 beats per minute (bpm); and standing PR of <40 or >140 bpm. Due to early termination of the study, only vital signs data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening and Days 1-2, 4-5, and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 for orthostatic (orth) measurements; Day 3 for supine measurements|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings. n=number of participants evaluable for that parameter|||participants|||Number
1338230|NCT01965600|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). Due to early termination of the study, only laboratory data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Baseline up to 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.|||participants|||Number
1338231|NCT01965600|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as newly occurring AEs or those worsening after first dose. Due to early termination of the study, only AE data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months)|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.|||participants|||Number
1338232|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0 to 2 Hours [AUC0-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
1338233|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0.5 to 2 Hours [AUC0.5-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
1338234|NCT01965600|Primary|Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
1338235|NCT01965561|Secondary|Pain During Tourniquet Application|Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.|1 minute||||mm on VAS||Standard Deviation|Mean
1338236|NCT01965561|Primary|Effectiveness at Stopping Distal Pulse|Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.|1 min||||percentage of participants|||Number
1338237|NCT01965535|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1338238|NCT01965535|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1338239|NCT01965535|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24||Weeks 1, 2, 4, 8, 12, and 24|Full Analysis Set|||percentage of participants|||Number
1338240|NCT01965535|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1338270|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338241|NCT01965535|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.~1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.~1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set)."|Posttreatment Week 12|Full Analysis Set: participant with genotype 1 HCV infection who were randomized and received at least 1 dose of active study drug.|||percentage of participants|||Number
1338242|NCT01965431|Secondary|Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)|||bpm||Standard Error|Mean
1338243|NCT01965431|Secondary|Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)|||bpm||Standard Error|Mean
1338244|NCT01965431|Secondary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment|"Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated.~QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. ‘Baseline’ denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1|ECG analysis set (ECGS)|||ms||Standard Error|Mean
1338245|NCT01965431|Primary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|"Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated.~QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. ‘Baseline’ denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|Electrocardiogram (ECG) analysis set (ECGS): all subjects in the treated set who had at least 1 baseline and post-baseline assessment for at least 1 ECG endpoint.|||ms||Standard Error|Mean
1338246|NCT01965366|Secondary|Change in The PTSD Symptom Scale Scores|"The PTSD Symptom Scale (PSS) is a 17-item interview used to aid in the detection and diagnosis of PTSD. The structure and content of the PSS mirror the DSM-IV criteria for PTSD. For each item, the interviewer assigns a rating to reflect a combination of frequency and severity (from O = not at all to 3 = 5 or more times per week/very much). Scores range from 0-51, with higher scores indicating more reported symptoms of PTSD. A score of 13 or higher indicates the likelihood of PTSD."|Baseline and immediate post treatment (up to 12 weeks from baseline)||||units on a scale||Standard Deviation|Mean
1338247|NCT01965366|Primary|Change in The Clinician Administered PTSD Scale (CAPS)Scores|The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD.|Baseline and immediate post treatment (up to 12 weeks from baseline)||||units on a scale||Standard Deviation|Mean
1338248|NCT01965327|Secondary|Change in Total Friedreich Ataxia Rating Scale (FARS) Score|The Friedreich Ataxia Rating Scale (FARS) is neurological rating scale specifically developed and validated for FRDA. The FARS includes assessments of stance, gait, upper and lower limb coordination, speech, proprioception and strength. In addition to the standard neurological examination, the FARS contains three quantitative performance measures and a component that assesses activities of daily living (ADL). Quantitative performance measures include the nine-hole peg test, and a timed 25-foot walk. FARS scores correlate significantly with functional disability, activities of daily living scores and disease duration. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|FARS score was calculated at the beginning and conclusion of treatment (baseline and 12 weeks)|The analysis was based on an intent-to-treat approach and included all subjects with baseline FARS assessment.|||units on a scale||Standard Deviation|Mean
1338249|NCT01965327|Primary|Change in Whole Blood Frataxin Levels|Assessment of the change in whole blood frataxin levels as assessed by lateral flow assay using an immunoassay for frataxin. Frataxin levels in the blood were measured at each study visit. Change in frataxin level at the end of treatment (week 12) relative to frataxin level at baseline was analyzed.|Frataxin levels were measured at the beginning and conclusion of treatment (baseline and 12 weeks)|The primary analysis was based on an intent-to-treat approach including all subjects who had baseline frataxin blood levels collected.|||percentage of baseline frataxin level||Standard Deviation|Mean
1338250|NCT01965288|Secondary|Participant Preference for Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; first study lenses, second study lenses, neither)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.|||percentage of participants|||Number
1338252|NCT01965288|Secondary|Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.|"Percentage of participants that answer the question, How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues? Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|8 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338253|NCT01965288|Secondary|Participant Recommendation of a Study Lens to Friends, Family or Colleagues|"Percentage of participants that answer the question, What study lens they will most likely recommend to friends, family or colleagues? Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)"|8 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338254|NCT01965288|Secondary|Participants Likelihood of Continuing to Wear the Study Lenses.|"Participants likelihood of continuing to wear either of the pairs of study lenses when asked; How likely are they to continue to wearing either the first study lenses or the second study lenses? Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338255|NCT01965288|Secondary|Participants Likelihood of Switching From Habitual Lenses to the Study Lenses|"Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses? Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of particpants|||Number
1338256|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of participants|||Number
1338257|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of participants|||Number
1338258|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of patients|||Number
1338259|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of patients|||Number
1338260|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338261|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338262|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338263|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338264|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338265|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338266|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338267|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338268|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338269|NCT01965288|Secondary|Corneal Neovascularization|Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338272|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338273|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338274|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338275|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338276|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338277|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338278|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338279|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338280|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
1338281|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338282|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338283|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338284|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338285|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338286|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338287|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
1338288|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
1338289|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338290|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338291|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338292|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338295|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|4 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
1338296|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|2 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
1338297|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|4 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
1338298|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|2 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
1338299|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA).~Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|4 Weeks|All 60 subjects randomized to both sets of lenses.|||logMAR||Standard Deviation|Log Mean
1338300|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA).~Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|2 Weeks|All 60 subjects randomized to both sets of lenses.|||logMAR||Standard Deviation|Log Mean
1338301|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
1338302|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
1338303|NCT01965288|Primary|Wavefront Aberrations RMS (3mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
1338304|NCT01965288|Primary|Wavefront Aberrations Root Mean Square (RMS) (3mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
1338305|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338306|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338307|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338308|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338309|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338310|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338311|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338312|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338313|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338314|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1339226|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338315|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338316|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338317|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338318|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338319|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338320|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338321|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338322|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338323|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338324|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338325|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338326|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338327|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)|4 Weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338328|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)|2 Weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
1338329|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|4 weeks|All 60 subjects randomized to both sets of lenses.|||hours||Standard Deviation|Mean
1338330|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|2 weeks|All 60 subjects randomized to both sets of lenses.|||hours||Standard Deviation|Mean
1338331|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses fitted|Participants||Number
1338332|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|Dispense|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
1338333|NCT01965288|Primary|Lens Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338334|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338335|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338336|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338337|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)|Dispense|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
1338338|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
1338339|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338340|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
1338341|NCT01965288|Primary|Visual Acuity logMAR|Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).|Dispense|All 60 subjects randomized to both sets of lenses.|||logMAR|Participants|Standard Deviation|Log Mean
1338342|NCT01965288|Primary|Vision Stability Upon Contact Lens Insertion|Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338343|NCT01965288|Primary|Vision Quality With Contact Lens Prescription|Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338344|NCT01965288|Primary|Vision Satisfaction Upon Contact Lens Insertion|Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338345|NCT01965288|Primary|Comfort Upon Contact Lens Insertion|Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
1338346|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
1338347|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
1338348|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
1338349|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
1338350|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
1338351|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
1338352|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline||||percentage of participants|||Number
1338353|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline||||percentage of subjects|||Number
1338354|NCT01965288|Primary|Vision Stability Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|Baseline||||units on a scale||Standard Deviation|Mean
1338355|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day|Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Baseline||||units on a scale||Standard Deviation|Mean
1338356|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|Baseline||||units on a scale||Standard Deviation|Mean
1339227|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338357|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline||||percentage of eyes|Participants||Number
1338358|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)|Baseline||||hours||Standard Deviation|Mean
1338359|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.|||units on a scale||Standard Deviation|Mean
1338360|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338361|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338362|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338363|NCT01965262|Primary|Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338364|NCT01965262|Primary|Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338365|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338366|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338367|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338368|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338369|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338370|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.|Baseline|7 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338371|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
1338372|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens movement measurements were obtained at baseline.|||Eyes|Eyes||Number
1338373|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
1338374|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at baseline.|||Eyes|Eyes||Number
1338375|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
1338376|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|Baseline|All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at baseline.|||Eyes|Eyes||Number
1339228|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338377|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
1338378|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|Baseline|All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at baseline.|||Eyes|Eyes||Number
1338379|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|1 week|11 subjects discontinued the study.|||participants|||Number
1338380|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|Baseline|All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at baseline.|||participants|||Number
1338381|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|1 week|11 subjects discontinued the study.|||participants|||Number
1338382|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|Baseline|All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at baseline.|||participants|||Number
1338383|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|1 week|11 subjects discontinued the study.|||participants|||Number
1338384|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|Baseline|All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline.|||participants|||Number
1338385|NCT01965262|Primary|Biomicroscopy - Hema-copolymer and Etafilcon A|Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
1338386|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.|||logMAR||Standard Deviation|Mean
1338387|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.|Baseline|All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.|||logMAR||Standard Deviation|Mean
1338388|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation.~The severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0."|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||SBMs with no straining / week||Standard Error|Least Squares Mean
1338389|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||complete spontaneous BMs / week||Standard Error|Least Squares Mean
1338390|NCT01965158|Secondary|Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.~Baseline was defined as the 14 days in the screening period prior to study drug administration."|Baseline and Week 1|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
1338391|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.~Baseline was defined as the 14 days in the screening period prior to study drug administration."|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
1338392|NCT01965158|Primary|Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.~A responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a “non-response” week.~Any participant with insufficient primary endpoint data (data for less than 9 out of 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder."|12-week treatment period|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
1338393|NCT01965067|Secondary|Heart Rate|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, Heart rate at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery||||beats/min||Standard Deviation|Mean
1338394|NCT01965067|Secondary|Mean Arterial Blood Pressure|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, mean arterial blood pressure at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery||||mmHg||Standard Deviation|Mean
1338395|NCT01965067|Other Pre-specified|Adverse Events|adverse effect of sugammadex(hypersensitivity, dry mouth, hypertension etc.)|During 7days after operation||||participants|||Number
1338396|NCT01965067|Other Pre-specified|Post-operative Nausea and Vomiting||During 7days after operation||||participants|||Number
1338397|NCT01965067|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 1day after operation||||participants|||Number
1338398|NCT01965067|Primary|Reversal Time of Rocuronium|The time from the administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition.|The recovery time to the TOF ratio of 0.9 after the administration of the sugammadex, an expected average of 5 minutes||||seconds||Standard Deviation|Mean
1338399|NCT01965002|Secondary|Percent Successful Tumor Ablation|In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.|Up to 1 week|Due to the complexity of 3-dimensional mapping of tumors in soft tissues, the precision necessary to capture baseline tumor volume exceeded the capability of the equipment. Baseline data per protocol for the outcome calculation was only obtained from a single participant, resulting in an inability to conduct a robust per protocol analysis.|||percent ablated volume|||Number
1338400|NCT01965002|Secondary|Adverse Event Severity|"Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades.~CTCAE Severity:~mild~moderate~severe~life-threatening~fatal"|6 months||||Treatment-related adverse events|||Number
1338401|NCT01965002|Primary|Overall Safety - Incidence of Any Device-related Adverse Events|Safety determined by evaluating for the incidence of any device-related adverse events. Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment. Safety is reported as the total incidence of device-related adverse events.|1 week|All participants were evaluated for adverse events.|||device-related adverse events|||Number
1338402|NCT01964976|Secondary|Change From Baseline in Fasting Insulin Level|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.|||microunits per milliliter||Standard Deviation|Mean
1338403|NCT01964976|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1338404|NCT01964976|Secondary|Percentage of Participants of Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1338405|NCT01964976|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1338406|NCT01964976|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
1338407|NCT01964976|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
1338408|NCT01964950|Secondary|Change From Baseline in Fasting Insulin Level|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.|||micro units per milliliter (mcU/mL)||Standard Deviation|Mean
1338409|NCT01964950|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the SU treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1338410|NCT01964950|Secondary|Percentage of Participants Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
1338411|NCT01964950|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1338412|NCT01964950|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reaction|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
1338413|NCT01964950|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
1338414|NCT01964898|Secondary|Negative Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months||||units on a scale||Standard Error|Mean
1338415|NCT01964898|Secondary|Positive Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance|Baseline to 6 months||||units on a scale||Standard Error|Mean
1338416|NCT01964898|Secondary|Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)|The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months||||units on a scale||Standard Error|Mean
1338417|NCT01964898|Secondary|Depression: 9 Item Patient Health Questionnaire (PHQ-9)|The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months||||units on a scale||Standard Error|Mean
1338418|NCT01964898|Primary|Time to Smoking Lapse|Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||Days||Standard Error|Mean
1338419|NCT01964898|Primary|Time to Smoking Relapse|Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||Days||Standard Error|Mean
1338420|NCT01964898|Primary|Continuous Abstinence From Smoking Since Discharge|Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||proportion of participants||95% Confidence Interval|Number
1338421|NCT01964898|Primary|Smoking Cessation: 7 Day Point Prevalence Abstinence|No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||proportion of participants||95% Confidence Interval|Number
1338422|NCT01964716|Secondary|Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here “n”= participants evaluable =specified category.|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.|||titer||95% Confidence Interval|Geometric Mean
1338423|NCT01964716|Secondary|Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here “n”= Number of participants with an antibody titer ≥ LLOQ for the given serotype.|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.|||percentage of participants||95% Confidence Interval|Number
1338424|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under ‘Screened Only’ arm.|Informed consent up to Dose 1|Safety population: participants who received at least 1 dose of study vaccine. Here “N”= participants evaluable for this outcome measure.|||participants|||Number
1338425|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state|Dose 1 up to 28 to 42 days after dose 3|Safety population included all participants who received at least 1 dose of study vaccine.|||participants|||Number
1338426|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.|||participants|||Number
1338434|NCT01964547|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of subjects who experienced an adverse event during the course of the study is presented.|0-50 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
1338435|NCT01964547|Secondary|Change From Baseline to End of Treatment in Timed 10-meter Walk Times.|Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||seconds||Standard Deviation|Mean
1338427|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.|||participants|||Number
1338428|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 1 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.|||participants|||Number
1338429|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.|||participants|||Number
1338430|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days and 'n' = participants whose response was “Yes” for any day or “No” for all days for specified local reaction.|||participants|||Number
1338431|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 1(Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.|||participants|||Number
1338432|NCT01964716|Primary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group|Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here “n”= participants with valid and determinate IgG concentration to the given serotype.|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1338433|NCT01964716|Primary|Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here “n”= participants with valid and determinate IgG concentration to the given serotype.|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1338463|NCT01963845|Secondary|LDL, Low-density Lipoprotein|LDL, measured in mg/dL at baseline and 24 weeks|Baseline and 24 weeks|All participants with LDL measurements at baseline and 24 weeks|||mg/dL||Inter-Quartile Range|Median
1338436|NCT01964547|Secondary|The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.|"Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation Without Intent, Active Suicidal Ideation With Intent, No Plan, Active Suicidal Ideation With Intent and Plan. The number of patients with a treatment-emergent flag is presented."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
1338437|NCT01964547|Secondary|Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.|At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||visits||Standard Deviation|Mean
1338438|NCT01964547|Secondary|Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.|All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1338439|NCT01964547|Secondary|Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Physicians were asked the following question to be rated on a seven-point scale:~How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
1338440|NCT01964547|Secondary|Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Caregivers were asked the following question to be rated on a seven-point scale:~How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
1338441|NCT01964547|Secondary|Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.|"Patients were asked the following question, to be rated on a seven-point scale:~Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below.~The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
1338442|NCT01964547|Secondary|Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.|The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1338443|NCT01964547|Primary|Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1338444|NCT01964521|Secondary|Levels of Pain in Connection to Dressing Changes.|Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain.|4 weeks|For some patients pain assessment was not performed at all predefined timepoints. Therefore some data were not collected.|||units on a scale||Standard Deviation|Mean
1338445|NCT01964521|Primary|Changes in Signs and Symptoms of Local Infection|Evaluation of signs of infection (exudate) from baseline|4 weeks|ITT|||Participants|||Count of Participants
1338446|NCT01964352|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
1338464|NCT01963845|Secondary|ALT, Alanine Aminotransferase|ALT, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with ALT measurements at baseline and 24 weeks|||IU/L||Inter-Quartile Range|Median
1338447|NCT01964352|Secondary|TDI Focal Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS|||Units on a scale||Standard Error|Mean
1338448|NCT01964352|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
1338449|NCT01964352|Primary|St. George’s Respiratory Questionnaire (SGRQ) Total Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS|||units on a scale||Standard Error|Mean
1338450|NCT01964352|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
1338451|NCT01964352|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints. The patient that entered the study with two different patient numbers was excluded from the FAS.|||L||Standard Error|Mean
1338452|NCT01964326|Secondary|"Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled Stop Use and Ask a Doctor Symptoms"|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The “Stop use and ask a doctor” symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days’ timeframe.|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who experienced any of the labeled Stop use and ask a doctor symptoms."|||Percentage of participants||95% Confidence Interval|Number
1338453|NCT01964326|Secondary|"Percentage of Participants Taking an Ask a Doctor or Pharmacist Before Use Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication"|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. ‘Ask a doctor or pharmacist before use’ medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who reported the use of any Ask a doctor or pharmacist before use medication."|||Percentage of participants||95% Confidence Interval|Number
1338465|NCT01963845|Secondary|AST, Aspartate Aminotransferase|AST, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with AST measurements at baseline and 24 weeks|||IU/L||Inter-Quartile Range|Median
1338466|NCT01963845|Primary|Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF|Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.|Baseline and 24 weeks||||percentage change in liver fat||Standard Deviation|Mean
1338509|NCT01963091|Secondary|Likert Scale Rating of Subjective Craving|Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'|0 mintues post 15 minute stress task||||units on a scale||Standard Deviation|Mean
1338454|NCT01964326|Primary|Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.|Day 1 up to Week 26|The analysis was performed on continuing users who checked their LDL-C during the study.|||Percentage of participants||95% Confidence Interval|Number
1338455|NCT01964326|Primary|Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.|Day 1 up to Week 26|The analysis was performed on the continuing users set which is a subset of the users set, defined as the users who continued taking the study medication for at least 6 weeks since the first date of the study treatment.|||Percentage of participants||95% Confidence Interval|Number
1338456|NCT01964222|Secondary|Attitudes About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported intent.|||units on a scale of 1 to 5||Standard Deviation|Mean
1338457|NCT01964222|Primary|Uncertainty in Choice|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall “uncertainty” score from 0 to 100. Higher values represent more uncertainty. Participation in study concludes upon completion of questionnaire.|1 day Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated uncertainty.|||units on a scale of 0 to 100||Standard Deviation|Mean
1338458|NCT01964222|Primary|Clarity of Values|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall “values clarity” score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated values clarity.|||units on a scale of 0 to 100||Standard Deviation|Mean
1338459|NCT01964222|Secondary|Self-efficacy for Communicating About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported self-efficacy for finding information about cancer clinical trials.|||units on a scale of 1 to 5||Standard Deviation|Mean
1338460|NCT01964222|Primary|Knowledge About Cancer Clinical Trials|"A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as Only very sick patients are asked to take part in a cancer research study and Cancer research studies almost never involve the use of a placebo or sugar pill alone. Participants will indicate each item as True, False, or I don't know. An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire."|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of percentage of knowledge questions answered correctly.|||percentage questions answered correctly||Standard Deviation|Mean
1338461|NCT01964105|Primary|Breast Q Augmentation Module|BREAST-Q is a validated measures of patient reported outcomes (this is not an acronym). For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score. Q-scores stand independently and are not combined to create a total score.|up to 6 months postop visit.||||units on a scale||Standard Deviation|Mean
1338462|NCT01963845|Secondary|HOMA-IR, Homeostatic Model Assessment of Insulin Resistance|HOMA-IR, calculated as [(glucose (mg/dL) X insulin (mg/dL)) / 405 ] at baseline and 24 weeks|Baseline and 24 weeks|All participants with HOMA-IR calculated at baseline and 24 weeks|||HOMA-IR score||Inter-Quartile Range|Median
1338467|NCT01963767|Secondary|Cognitive Performance|The secondary endpoint will be improvement in cognitive performance over the two-month follow-up period on the paper and pencil tests of cognitive ability. The test that was used here is the Identical Pictures test, from the Educational Testing Services battery (Ekstrom RB, French JW, Harman HH, Dermen D. Manual for kit of factor referenced cognitive tests. Educational Testing Service, Princeton, NJ, 1976.). This test evaluates the number of pictures that persons can match within a 90 second period. There are two trials at 90 seconds and the maximum score is 48 matches (minimum is 0). Higher scores indicate better performance because participants are able to make more matches within the 90 second interval. This test provides an index of processing speed, the ability to do a task rapidly.|Measured at baseline and two months||||units on a scale||Standard Error|Mean
1338468|NCT01963767|Primary|Delay Eyeblink Conditioning|"Participants will be tested on eyeblink classical conditioning at the USF Health Byrd Alzheimer's Institute. Participants will receive 60 trials of eyeblink conditioning at the two-month follow-up point. Participants watch an entertaining silent video (e.g., Milo and Otis). The airpuff is delivered through a nozzle held in front of the participant and blink latency is recorded.~The outcome measure is an index of the percentage of eyeblinks that are made to a tone (conditioned stimulus) after the learning period is complete. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned; Woodruff-Pak, D. S. (2001). Eyeblink classical conditioning differentiates normal aging from Alzheimer's disease. Integrative Physiological and Behavioral Science, 36(2), 87-108.)."|Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses|From the 105 persons with complete data on the second outcome, only 102 had complete data on this outcome. The three who did not contribute to this analysis were because there were two equipment failures and one person had a glass eye and the procedure could not be performed.|||percentage of conditioned responses||Standard Deviation|Mean
1338469|NCT01963676|Secondary|Persistence of Decrease in AHRS Score Over Time|We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.|Day 5, One month|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.|||units on a scale||Standard Deviation|Mean
1338470|NCT01963676|Primary|Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5|Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.|Baseline, Day 5|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.|||units on a scale||Standard Deviation|Mean
1338471|NCT01963611|Secondary|Mean Change From Baseline in Brain Volume Per Subject|Change from baseline in brain volume per subject was calculated using 5 series MRI scan.|Baseline, Weeks 24, 28, 32, 36, 40|The Outcome Measure was not derived due to early termination of the study.||||||
1338472|NCT01963611|Secondary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|The Outcome Measure was not derived due to early termination of the study.||||||
1338473|NCT01963611|Secondary|Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||cubic millimeter (mm^3)||Standard Deviation|Mean
1338474|NCT01963611|Secondary|Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||cubic millimeter (mm^3)||Standard Deviation|Mean
1338475|NCT01963611|Secondary|Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan|New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.|Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||lesions/subject/scan||Standard Deviation|Mean
1338476|NCT01963611|Secondary|Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan|New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36,40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||lesions/subject/scan||Standard Deviation|Mean
1338477|NCT01963611|Secondary|Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36, 40|"ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||lesions/subject/scan||Standard Deviation|Mean
1338488|NCT01963260|Primary|Number of Participants Discontinuing Study Due to an Adverse Event (AE)|An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 84 Days|The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis.|||Participants|||Number
1339229|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338478|NCT01963611|Secondary|Percentage of Subjects Remaining Relapse-Free|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).|||percent subjects|||Number
1338479|NCT01963611|Secondary|Mean Annualized Relapse Rate (ARR)|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).|||percent relapse||Standard Deviation|Mean
1338480|NCT01963611|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.|Baseline , Week 12, 24, 28, 32, 36, 40|Intent to Treat (ITT) analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||lesions per subjects per scan||Standard Deviation|Mean
1338481|NCT01963403|Other Pre-specified|Bleeding Patterns and Number of Participants With Bleeding Improvement|"Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle~Bleeding improvement over the 84 days of study participation~Bleeding patterns in placebo vs. combined oral contraceptive users"|Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months||||Participants|||Count of Participants
1338482|NCT01963403|Other Pre-specified|Number of Participants withTreatment Success or Failure|"Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better.~Partial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work~Complete failure of treatment will be measured by the desire to:~discontinue treatment because it did not work; no further treatment requested~ETG implant removal~Desire to use non-study treatment"|Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months|one month evaluation; 1 subject LTFU at one month in each group|||Participants|||Count of Participants
1338483|NCT01963403|Secondary|Number of Participants With Adverse Events|Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.|Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant|Outcomes at one month; 1 person LTFU at one month in each group|||Participants|||Count of Participants
1338484|NCT01963403|Primary|Number of Participants With Bleeding Improvement|Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.|Bleeding improvement will be evaluated during first cycle of study treatment (28 days)|1 person in each group LTFU at one month, which was the primary outcome|||Participants|||Count of Participants
1338485|NCT01963260|Secondary|Maximum Concentration (Cmax) of MK-8723 Among Healthy Participants and Participants With ITP|Serum samples for determination of Cmax were collected at pre-specified time-points.|All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for this pharmacokinetic (Cmax) analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1338486|NCT01963260|Secondary|Area Under the Concentration-time Curve of MK-8723 From Time 0 to Infinity (AUC0-∞) Among Healthy Participants and Participants With ITP|AUC0-∞ is a measure of total body exposure to drug. Serum samples for determination of AUC0-∞ were collected at pre-specified time-points.|All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacokinetic (AUC0-∞) analysis.|||hr*μg/mL||Geometric Coefficient of Variation|Geometric Mean
1338487|NCT01963260|Primary|Number of Participants With a Positive Platelet Response to MK-8723|In participants with ITP, platelet response is a rapid, sensitive, and highly qualitative measure of response to anti-inflammatory therapy. A positive platelet response was defined as: 1) A doubling of platelet counts at the time point of maximum response (through Day 14) as compared to Day 0 AND an increase to an absolute level of ≥50,000/μL in participants with a baseline platelet count of <50,000/μL, OR 2) A 50% increase in the platelet count at the time point of maximum response (through Day 14) as compared to Day 0 in participants with a baseline platelet count of ≥50,000/μL. The analysis was specified only for participants with ITP (Part 2) that received treatment with MK-8723 or matching placebo.|Up to Day 14|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacodynamic (platelet response) analysis.|||Participants|||Number
1338508|NCT01963143|Primary|Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects||After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion|PK population|||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
1338489|NCT01963260|Primary|Number of Participants Experiencing an Adverse Event|An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 84 days|The All Participants as Treated (APaT) population consisting of all participants who received at least one dose of study drug was used for the safety analysis.|||Participants|||Number
1338490|NCT01963234|Secondary|Total Costs for Clinic|This includes the clinic operating costs and clinic implementation costs of the intervention.|6 months|"This outcome measure was analyzed at the clinic level. Thus, NA is indicated for Overall number of participants analyzed."|||US dollars|clinic||Number
1338491|NCT01963234|Secondary|Clinical Adoption|We analyzed computerized system log files to produce patterns of system adoption of the staff.|up to 3 years|This is the number of primary care clinical staff at the 3 sites who adopted using Seva.|||Participants|||Count of Participants
1338492|NCT01963234|Secondary|Number of Patients Using System|Analysis for measure was done for the total of all three sites combined.|up to 3 years||||Participants|||Count of Participants
1338493|NCT01963234|Primary|Patients Partook in HIV Testing in the Last 6 Months|Analysis for measure was done for the total of all three sites combined.|6 months|Overall number of participants analyzed is lower because data is self reported and patients could chose not to answer some questions.|||Participants|||Count of Participants
1338494|NCT01963234|Primary|Patients Partook in HIV Risky Behavior in the Last 6 Months|Analysis for measure was done for the total of all three sites combined.|6 months||||Participants|||Count of Participants
1338495|NCT01963234|Primary|Patients, Within the Last 6 Months Have Received Other Addiction Treatment|Analysis for measure was done for the total of all three sites combined.|6 months||||Participants|||Count of Participants
1338496|NCT01963234|Primary|Patient Had Any Drink or Drug Use Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Overall number of participants analyzed because data was self reported and patients were allowed to not answer questions if they chose.|||Participants|||Count of Participants
1338497|NCT01963234|Primary|Patient Had Illicit Drug Use Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||Participants|||Count of Participants
1338498|NCT01963234|Primary|Patient Had Any Drink Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||Participants|||Count of Participants
1338499|NCT01963234|Primary|Mental Subscale Quality of Life|Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||score on a scale||Standard Deviation|Mean
1338500|NCT01963234|Primary|Physical Subscale Quality of Life|Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||score on a scale||Standard Deviation|Mean
1338501|NCT01963234|Primary|Overall Quality of Life|Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||score on a scale||Standard Deviation|Mean
1338502|NCT01963234|Primary|Illicit Drug-use Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||days||Standard Deviation|Mean
1338503|NCT01963234|Primary|Risky Drinking Days in the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||days||Standard Deviation|Mean
1338504|NCT01963234|Primary|Any Drinking Days in Last 30 Days||6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||days||Standard Deviation|Mean
1338505|NCT01963234|Primary|Implementation Status|The number of implementation milestones completed|up to 3 years|These are milestones achieved for each site.|||milestones|Milestones||Number
1338506|NCT01963143|Secondary|Secondary Bioequivalence Analysis - IgG Trough Levels||After a minimum 5 infusions on each product, at pre-infusion.||||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
1338507|NCT01963143|Secondary|Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects||After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion||||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
1338510|NCT01963091|Secondary|Likert Scale Rating of Subjective Stress|Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'|0 minutes post 15 minute stress task||||units on a scale||Standard Deviation|Mean
1338512|NCT01962974|Secondary|Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)|The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.||||||
1338513|NCT01962974|Secondary|Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab|The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.||||||
1338514|NCT01962974|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.||||||
1338515|NCT01962961|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Measure of endothelial function|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.|||Percentage of vessel diameter||Standard Deviation|Mean
1338516|NCT01962961|Primary|Change in Circulating F2-isoprostane Levels|Oxidative stress measure|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.|||pg/mL||Standard Deviation|Mean
1338517|NCT01962961|Primary|Change in Circulating Malondialdehyde Levels|Measure of oxidative stress|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.|||micromolar||Standard Deviation|Mean
1338518|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the Protocol PK population N= 46 was used.|||ng/mL||Standard Deviation|Mean
1338519|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measuure the Protocol PK population of N = 46 was used.|||ng/mL||Standard Deviation|Mean
1338520|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the PK population N=46 was used.|||ng*hr/mL||Standard Deviation|Mean
1338521|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours"|Day 14|For this outcome measuure the Protocol PK population N= 46 was used.|||ng/mL||Standard Deviation|Mean
1338522|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measuure the Protocol PK population of N = 46 was used.|||ng/mL||Standard Deviation|Mean
1338523|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measure the PK population N=46 was used|||ng*hr/mL||Standard Deviation|Mean
1338584|NCT01961115|Secondary|Changes in the Level or Character of the Vaccine-induced CD8+ and CD4+ Specific T-cell Immune Responses by IFN-gamma ELISPOT_v2|Assessment of immunologic response will be based on a fold-increase measure from baseline as well as using a positivity threshold|Baseline to up to 16 weeks|Data were not collected||||||
1338524|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the Protocol PK population N= 46 was used.|||ng/mL||Standard Deviation|Mean
1338525|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measuure the Protocol PK population of N = 46 was used.|||ng/mL||Standard Deviation|Mean
1338526|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the PK population N=46 was used.|||ng*hr/mL||Standard Deviation|Mean
1338527|NCT01962688|Secondary|Length of Stay|length of stay in the hospital for inpatient arms only|up to 6 months|Data not collected||||||
1338528|NCT01962688|Secondary|Change in Health Related Quality of Life|Change in Health related quality of life at 6 months as compared to at 1 month|1 month and 6 months|Data not collected||||||
1338529|NCT01962688|Secondary|Number of Participants in Each New York Heart Association Class|"New York Heart Association (NYHA) Classification Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.~Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.~Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest.~Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|6 months|Analyzed total 96 visits|||visits|Number of Visits||Number
1338530|NCT01962688|Primary|Diuretic Change Post-visit|Differences in Changes made in Diuretic doses after Heart failure related visit|6 months followup||||Number of visits|Number of visits||Count of Units
1338531|NCT01962688|Primary|Number of Participants Hospitalized for Non-cardiac Reasons|hospitalization information will be recorded throughout the length of the study for the inpatient arms|up to 6 months|All patients in clinical assessment only group were hospitalized for non-cardiac reasons|||Participants|||Count of Participants
1338532|NCT01962688|Primary|Number of Participants Hospitalized for Cardiovascular Reasons|hospitalization information will be recorded throughout the length of the study for the outpatient arms|up to 6 months||||Participants|||Count of Participants
1338533|NCT01962675|Secondary|Change From Baseline Score on Toe Tap Test|Measuring the Time required to perform toe taps|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
1338534|NCT01962675|Secondary|Change From Baseline Scores of a 10 m Walk Test|Change from baseline score of the time required to perform 10 m walking.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
1338535|NCT01962675|Primary|Change From Baseline Active Motor Threshold|Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
1338536|NCT01962675|Primary|Change From Baseline Midswing Ankle ROM|Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
1338537|NCT01962558|Other Pre-specified|Change in Tinnitus Functional Index (TFI)|Assess the change in TFI score for both groups and compare between the groups. The TFI has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. There are a total of 25 questions, with a range of 0 to 10 on each item (0 to 250) total. All valid answers are summed, divided by the number of questions which were answered, and multiplied by 10 (0-100 range). Score range from 0 to 100 with higher scores indicating worse tinnitus.|6-weeks (pre-implant to after 6-weeks of VNS)||||units on a scale||95% Confidence Interval|Mean
1338538|NCT01962558|Secondary|Change in Tinnitus Handicap Questionnaire (THQ)|Assess the change in THQ score for both groups and compare between the groups. The THQ is a patient questionnaire with 27 questions with each question having a score from 1 to 100. Scoring includes three factors - Factor 1 (Social, Emotional, Behavioral), Factor 2 (Tinnitus and Hearing), Factor 3 (Outlook). Fifteen questions are included in Factor 1, 8 questions in Factor 2, and 4 questions in Factor 3. A total score is calculated by adding the scores for Factor 1 questions and multiplying by 15/27, adding the scores for Factor 2 and multiplying by 8/27, and adding the scores for Factor 3 and multiplying by 4/27. This is then summed for the total score. Total score ranges from 0 to 100, with higher scores indicating more severe tinnitus.|6-weeks (pre-implant to after 6-weeks of VNS)||||units on a scale||95% Confidence Interval|Mean
1338585|NCT01961115|Secondary|Changes in Expression of IDO1 Protein by IHC in Tumor or Tumor-infiltrating Cells_v2||Baseline to up to 16 weeks|Data were not collected||||||
1338586|NCT01961115|Secondary|Change in the Number and Character of PBMC Populations, Including T and NK Cells, as Evaluated by Multiparameter Flow Cytometry_v2||Baseline to up to 1 year|Data were not collected||||||
1338587|NCT01961115|Secondary|Change in PBMC Transcriptome_v2|Analysis of PBMC gene signature. This may be compared to immunologic response, tumor biopsy data and clinical response|Baseline to up to 16 week|Data were not collected||||||
1338539|NCT01962558|Secondary|Percent Change in Tinnitus Handicap Inventory (THI)|Assess the change in THI score for both groups and compare between the groups. The THI is a questionnaire that asks subjects to assess their perception of their tinnitus by rating each question as a Yes (4 points), No (0 points) or Sometimes (2 points). There are 25 questions, scores are summed, so the scale ranges from 0 to 100. Scores are graded as: Grade 1 - Slight (0-16) Only heard in a quiet environment; Grade 2 - Mild (18-36) Easily masked by environmental sounds and easily forgotten with activities.; Grade 3 - Moderate (38-56) Noticed in presence of background noise, although daily activities can still be performed.; Grade 4 - Severe (58-76) Almost always heard, leads to disturbed sleep patterns and can interfere with daily activities.; Grade 5 - Catastrophic (78-100) Always heard, disturbed sleep patterns, difficulty with any activities.|6-weeks (pre-implant to after 6-weeks of VNS)||||percentage change of THI||95% Confidence Interval|Mean
1338540|NCT01962558|Secondary|Change in Minimum Masking Level (MML) in Units of dB (Decibels)|Asses the change in minimum masking level (MML) for both groups and compare between the groups.|6-weeks (pre-implant to after 6-weeks of VNS)||||dB (decibels)||95% Confidence Interval|Mean
1338541|NCT01962558|Secondary|Number of Participants With Adverse Events|Assess the number of adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.|6-weeks||||participants|||Number
1338542|NCT01962558|Primary|Number of Participants With Serious Adverse Events|Assess the number of serious adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.|6-weeks||||participants|||Number
1338543|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338544|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338545|NCT01962493|Secondary|Overall Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338546|NCT01962493|Secondary|Overall Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338547|NCT01962493|Secondary|Overall Facial MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338548|NCT01962493|Secondary|Overall Facial MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338549|NCT01962493|Secondary|Overall MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338550|NCT01962493|Primary|Modified Lobene Stain Index (MLSI) at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
1338551|NCT01962441|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1338552|NCT01962441|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1338553|NCT01962441|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1338554|NCT01962441|Secondary|HCV RNA at Weeks 1, 2, 4, 8, and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1338555|NCT01962441|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1338556|NCT01962441|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1338557|NCT01962441|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1338558|NCT01962441|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1338559|NCT01962428|Secondary|Bleeding Events||follow-up for 28 days after the loading dose of ticagrelor|||||||
1338560|NCT01962428|Secondary|Platelet Reactivity Index (PRI) Measured by VASP-P||0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor|||||||
1338561|NCT01962428|Primary|Platelet Reactivity Index(PRI) Measured by VASP-P|Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).|2 hours after the loading dose of ticagrelor||||percentage of 100||Inter-Quartile Range|Median
1338562|NCT01961544|Secondary|Disease Control Rate (DCR)|DCR is defined as the number of participants with complete response (CR), partial response (PR), and stable disease (SD). The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess the tumor response. Tumor response was evaluated by investigators. CR is defined as the disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]. The SLD must also demonstrate an absolute increase of at least 5 mm. [Two lesions increasing from 2 mm to 3 mm, for example, does not qualify]).|mean of 3.76 months|Full Analysis Set: participants who were administered investigational product at least once after enrollment and had at least one primary efficacy data value since Baseline|||Participants|||Number
1338579|NCT01961271|Primary|Efficacy According to BS-11 Pain Score Reduction|"The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score.~BS-11 is known as Box scale-11; it is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Maximum 17 weeks starting from enrolment|Subjects of the analysis population met the eligibility criteria. It consists of subjects who completed the study and who withdrew for any reason.|||units on a scale||Standard Deviation|Mean
1338580|NCT01961115|Secondary|Time to Tumor Progression Using RECIST or irRC_v2||Up to 1 year|Data were not collected||||||
1338563|NCT01961544|Primary|Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)|An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.|mean of 3.76 months|Safety Set: all participants who are administered investigational product at least once for the analysis|||Participants|||Number
1338564|NCT01961349|Primary|Achivement of Target Sedation|The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.|from scope-in to scope-out|FAS (Full Analysis Set)|||% of patients||95% Confidence Interval|Number
1338565|NCT01961349|Secondary|PSSI Total Score|PSSI (Statistics of Patient Satisfaction with Sedation Instrument) total score obtained from 20 questions (1 to 7 points for each) adjusted to have range of 0 ( very dissatisfied: all items scored with 1 point) to 100 (very satisfied: all items scored with 7 points)|at 24-48 h after endoscopy|FAS (Full Analysis Set)|||Score on a scale (0 - 100)||Standard Deviation|Mean
1338566|NCT01961323|Secondary|Untwist Rate of the Left Ventricle|measured as a part of stress echocardiogram, number of participants with significant improvement in the LV untwist after Nebivolol treatment in patients who completed the study|at 6 months||||Participants|||Count of Participants
1338567|NCT01961323|Secondary|E Velocity Indexed to e’ (E/e’ Ratio) of the Left Ventricle|measured as a part of stress echocardiogram, E/e' ratio: The normal E/e' ratio from the medial annulus is <8 and suggests a normal left atrial pressure. While values between 8 and 12 are indeterminate, a value >12 is indicative of an elevated left atrial pressure or PCWP (>18mmHg). The ranges for E/e' from the lateral mitral annulus are <5, 5 -10 and >10 respectively.|at 6 months|Results for the participants who had improved exercise capacity only (from Outcome Measure 1)|||ratio||Standard Deviation|Mean
1338568|NCT01961323|Primary|Improvement in Exercise Tolerance|measured by stress echocardiogram, number of participants who had improvement in METS and improvement in exercise time as compared to their baseline.|at 6 months|Study results only for those who completed the study|||Participants|||Count of Participants
1338569|NCT01961297|Secondary|Voice Tremor Severity|Visual analog scale of severity (0 for none, 100 for most severe/profound)|baseline and Day 1|Only alcohol-responsive participants with voice tremors were included in analysis|||units on a scale||Standard Deviation|Mean
1338570|NCT01961297|Secondary|Breathlessness Severity|Visual analog scale of severity (0 for none, 100 for most severe/profound)|baseline and Day 1|Only alcohol-responsive participants were included in analysis|||units on a scale||Standard Deviation|Mean
1338571|NCT01961297|Secondary|Voice Harshness Severity|Visual analog scale of severity (0 for none, 100 for most severe/profound)|baseline and Day 1|Only alcohol-responsive participants were included in analysis|||units on a scale||Standard Deviation|Mean
1338572|NCT01961297|Secondary|Number of Voice Breaks|The number of SD-characteristic voice breaks in each sentence at pre-drug and post-drug assessment|baseline and Day 1|Only alcohol-responsive participants were included in analysis|||voice breaks||Standard Deviation|Mean
1338573|NCT01961297|Primary|Number of Participants Who Reported Positive Effects.|Number of participants who had reported positive effects of at least one alcohol drink on their voice symptoms|Day 1|Only alcohol-responsive participants were in this analysis which is 23 from the SD group and 22 from the SD/VT group.|||Participants|||Count of Participants
1338574|NCT01961271|Secondary|Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.||From time of enrolment to Visit 6 (ie. up to119 days from enrolment)||||participants|||Number
1338575|NCT01961271|Secondary|Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)||||units on a scale||Standard Deviation|Mean
1338576|NCT01961271|Secondary|Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication|Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries.|Approximately 17 weeks starting from enrolment||||participants|||Number
1338577|NCT01961271|Secondary|Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE|Side effects of the transdermal patch treatment will be analysed.|From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)||||participants|||Number
1338578|NCT01961271|Secondary|Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention|"Pre-intervention: Visit 1 Post-intervention: Visit 6~There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here:~Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed"|approximately 17 weeks starting from enrolment||||percentage of subjects|||Number
1338581|NCT01961115|Secondary|Overall Survival_v2||From the time measurement criteria are met for complete response or partial response until the first date that recurrent and progressive disease is objectively documented, assessed up to 1 year|Data were not collected||||||
1338588|NCT01961115|Primary|Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios in Combination With MELITAC 12.1|Immunohistochemistry: Tumors (day 21 & day 42) were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.|Day 21 up to Day 42|"Neither subject in cohort A had day 42 tumor biopsy material available. For analysis of Cohort All Other Patients n = 6 due to either a day 21 biopsy missing or a missing day 42 biopsy."|||Mean Ratio: Day42CD8s/Day21CD8s||Full Range|Mean
1338589|NCT01961115|Primary|Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios.|Immunohistochemistry: Tumors were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.|Baseline to up to day 21|"For one subject in cohort A day 21 tumor biopsy material was not obtained (For analysis of Cohort A n = 1). For analysis of Cohort All Other Patients n = 7 due to day 21 biopsy not being obtained in 2 other subjects. In addition, for one of those subjects there was no baseline tumor biopsy obtained."|||Ratio: Day21CD8s/Day0CD8s||Full Range|Mean
1338590|NCT01961089|Primary|Agreement With Predicate Devices in Terms of Agreement|"Assessed Parameters:~Simulated Corneal Curvature (SimK)"|3 months|SimK|||Diopters||Standard Deviation|Mean
1338591|NCT01961089|Secondary|Agreement With Devices of the Same Type in Terms of Repeatability|"Assessed parameters:~Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW)"|3 months|All|||Coefficient of variation|Eyes||Number
1338592|NCT01961089|Primary|Agreement With Predicate Devices in Terms of Agreement|"Assessed parameters:~Axial Length (AL; G6, IOLM, LS) Central Corneal Thickness (CCT; G6, LS)) Anterior Chamber Depth (ACD; G6, IOLM, LS) Lens Thickness (LT; G6, LS) Corneal Curvature (SimK; G6, IOLM, LS) White-to-White (WtW; G6, IOL, LS)"|3 months|The measurement of Central Corneal Thickness (CCT) and Lens Thickness (LT) is not possible with the IOLM: the IOLM cannot measure these two parameters and does therefore not display results for CCT and LT. As a consequence, the comparison in CCT and LT is only possible between the G6 and the LS, but not with respect to the IOLM.|||Units are mm|eyes|Standard Deviation|Mean
1338593|NCT01960907|Post-Hoc|Difference of Hospitalization Rate|Difference between the hospitalization rate during the study and the previous year. For each patient, hospitalization rate was defined as the number of hospital admissions during a period divided by the length (in days) of the period. Number of hospitalizations was collected by the hospital clinical records.|Baseline and 9 months||||hospitalizations/year/patient||Inter-Quartile Range|Median
1338594|NCT01960907|Primary|Final Utility Index of EQ-5D Questionnaire|The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life.|9 months|An intention to treat analysis has been applied for the primary outcomes of the trial. Multiple Imputation (MI) was used to assign values were data were missing. However for a limited number of patient, due to the fact that all data were missing, we couldn't apply any imputation method and therefore they have been excluded.|||units on a scale||Standard Deviation|Mean
1338595|NCT01960907|Primary|Time to First Hospitalization|It represents the number of days, since the enrolment into the study, to the first hospitalization|From enrolment up to 9 months|An intention to treat analysis has been applied for the primary outcomes of the trial and all the randomized patients have been retained for the analysis.|||days||Inter-Quartile Range|Mean
1338596|NCT01960855|Secondary|Number of Subjects Achieving CR Based on DAS28 at Week 12|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
1338597|NCT01960855|Secondary|Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12|LDA is defined as DAS28 from 2.6 to < 3.2 at Week 12. CR is defined as DAS28 (CRP) < 2.6 at Week 12. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
1338598|NCT01960855|Secondary|Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12|Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
1338599|NCT01960855|Secondary|Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12|Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
1338600|NCT01960855|Primary|Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient’s assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire – Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.|Baseline (Week 0) and Week 12|Subjects in the modified intent-to-treat (mITT) population with a baseline value and at least 1 post-baseline value|||Participants|||Count of Participants
1338656|NCT01960296|Primary|Bleeding-related Re-hospitalization|Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.|up to 90 days post op||||participants|||Number
1338601|NCT01960842|Other Pre-specified|Physical Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for physical examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|||||||
1338602|NCT01960842|Other Pre-specified|Neurological Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for neurological examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|||||||
1338603|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG)|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), QT interval corrected for heart rate using Fridericia's formula (QTcF), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively. n = the number of participants with available data at each time point.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
1338604|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
1338605|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f), males (m), and femtoliters (fL).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
1338606|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), body temperature (Temp), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
1338607|NCT01960842|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs (TEAEs) are defined as any event that began or worsened in severity after N-J placement. The investigator assessed the relationship of each event to the use of study drug as Reasonable Possibility or No Reasonable Possibility.~For more details on adverse events please see the AE section below."|From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.|Safety Analysis Set: All subjects who had undergone the N-J placement procedure.|||participants|||Number
1338608|NCT01960842|Secondary|Average Daily Normalized “Off” Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. n= the number of participants with available data at each time point."|Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
1338609|NCT01960842|Secondary|Average Daily Normalized “Off” Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
1338610|NCT01960842|Secondary|Average Daily Normalized “Off” Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
1338611|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0 to 23 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
1339230|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338612|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0 to 16 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
1338613|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0 to176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline and Final PEG-J Visit (up to Week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
1338614|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items (each question answered on a 5-point scale) addressing 8 domains of health in Parkinson's disease patients: Mobility (e.g., fear of falling when walking) includes 10 questions; Emotional Well-being (e.g., feelings of isolation) includes 6 questions; Stigma (e.g., social embarrassment) includes 4 questions; Social Support includes 3 questions; Cognition includes 4 questions; Communication includes 3 questions; and Bodily Discomfort includes 3 questions. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
1338615|NCT01960842|Secondary|"Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
1338616|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
1338617|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
1338618|NCT01960842|Secondary|Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit|"The PGI-C is a 7-point response scale. The subjects were to rate their change in status from Screening Visit 1 using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. The responses of Minimally improved, Much improved, and Very much improved on the PGI-C were used to define responders."|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||units on a scale||Standard Deviation|Mean
1338619|NCT01960842|Secondary|Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit|The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||units on a scale||Standard Deviation|Mean
1338620|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
1338621|NCT01960842|Secondary|"Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
1338622|NCT01960842|Primary|Average Daily Normalized “Off” Time: Change From Baseline To The Final PEG-J Visit|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the Full Analysis Set (FAS; all enrolled participants who received at least 1 dose of LCIG infusion during the PEG-J Period and had data for baseline and at least 1 post-PEG-J efficacy assessment) with available data.|||hours||Standard Deviation|Mean
1338623|NCT01960816|Post-Hoc|NOSE Score at 90-day Follow-up|The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity. Each subject's NOSE score at the 90-day follow-up was compared to that subject's baseline NOSE score to determine change in nasal obstruction symptoms.|90 days|Subjects with 90-day follow-up data|||units on a scale||Standard Deviation|Mean
1338624|NCT01960816|Primary|Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue|Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.|Procedure, up to 1 hour (average, 16 minutes)|All enrolled subjects underwent the procedure.|||participants|||Number
1338625|NCT01960816|Primary|Incidence of Unanticipated Serious Adverse Device Effects|The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)|90 Days|One subject was lost-to-follow-up prior to the 90-day follow-up visit. Therefore, 32 subjects were available for analysis at the 90-day time point.|||events|||Number
1338626|NCT01960725|Other Pre-specified|Serious Adverse Event Assessment|Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined|After each dose and up to 10 months post-vaccination||||Proportion of participants|||Number
1338627|NCT01960725|Other Pre-specified|Adverse Event Assessment|Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined|28 days after each dose, up to 10 months post-vaccination||||Proportion of participants|||Number
1338628|NCT01960725|Other Pre-specified|Reactogenicity Assessment|Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined|7 days after each dose, up to 10 months post-vaccination|Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any does of RV5 will be determined|||Proportion of participants|||Number
1338629|NCT01960725|Other Pre-specified|Serum Rotavirus Immunoglobulin A|Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
1338630|NCT01960725|Secondary|P1 Serum-neutralizing Antibody|Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
1338631|NCT01960725|Secondary|G4 Serum-neutralizing Antibody|Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
1338632|NCT01960725|Secondary|G3 Serum-neutralizing Antibody|Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
1338633|NCT01960725|Secondary|G2 Serum-neutralizing Antibody|Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
1338634|NCT01960725|Primary|G1 Serum-neutralizing Antibody|Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
1338635|NCT01960530|Primary|AUC0-t|Derived PK for Serum Cortisol: Area under the curve from 0-24 hours|Hourly from 0 to 24 hours|All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol|||nmol*h/L||Standard Deviation|Geometric Mean
1338636|NCT01960530|Secondary|PK and Metabolism of Cortisol|Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.|Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period||||nmol/L||Standard Deviation|Mean
1339231|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338637|NCT01960530|Secondary|Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.|A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.|Blood samples on Day 1 and/or Day 2 of each Study Period||||uIU/mL||Standard Deviation|Mean
1338638|NCT01960530|Secondary|Concentrations of Cortisol Binding Protein|Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.|Blood samples on Day 1 and/or Day 2 of each Study Period||||ug/mL||Standard Deviation|Mean
1338639|NCT01960530|Secondary|Adverse Events (AEs)|Number of subjects with adverse events throughout the study.|Days 1-2 during each Study Period||||participants|||Number
1338640|NCT01960530|Primary|Maximum Serum Concentration (Cmax)|Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)|Hourly from 0 to 24 hours|All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol|||nmol/L||Standard Deviation|Geometric Mean
1338641|NCT01960400|Secondary|State Anxiety|The State-Trait Anxiety Inventory (STAI) was used to assess the state of anxiety at the moment (Spielberg et al., 1983). The total score is obtained by adding the scores for all 20 questions range from 20 to 80; the higher the result is, the higher is the anxiety about an event.|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
1338642|NCT01960400|Secondary|Kinesiophobia|The Tampa Scale of kinesiophobia (TSK) (Kori et al., 1990) was used to assess fear of movement and injury/(re)injury. The TSK questionnaires consist of 17 items. Each item, composed of a statement, is scored by the patient on a 4-point Likert scale of 1 (strongly disagree) to 4 (strongly agree). The total scores range from 17 to 68, with higher scores representing stronger fear-avoidance beliefs (Clark, Kori, Brockel, 1996).|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
1338643|NCT01960400|Secondary|Pain Catastrophizing|"The Pain catastrophizing scale (PCS) (Sullivan et al., 1995) was used to evaluate the feelings, thoughts, and emotions related to pain catastrophizing of the patient. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness.~* The scores ranging from 0 to 52 points (sum of the tree subscales), with higher scores representing stronger pain catastrophizing (Sullivan et al., 1995)."|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
1338644|NCT01960400|Primary|Pain Severity|"The choice of outcome measures was performed in accordance with Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) guidelines (Dworkin et al., 2005). All instruments were used before (T0) and after 6 weeks of treatment (T1).~The primary outcome measure was pain severity as measured with the Brief pain inventory short-form (BPI-sf) (Poundja et al., 2007). The BPI-sf includes four questions on pain levels, where subjects were asked to rate intensity on a scale of 0 (no pain) to 10 (worst possible pain) for: (1) pain at its worst in the last 24 hours; (2) pain at its least in the last 24 hours; (3) pain on average in the last 24 hours; (4) pain right now. The total score ranges from 0 to 40 (sum of the four subscales). The higher the score, the greater the severity of the pain is severe."|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
1338645|NCT01960387|Secondary|Predictive Factors for Response to Treatment.|Evaluation of potential factors that are predictive of clinical response in newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 1 year|Results data are not available due to low/insufficient subject accrual from early [trial] termination.||||||
1338646|NCT01960387|Secondary|Relapse Free Survival|Number of months of relapse free survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.||||||
1338647|NCT01960387|Secondary|Overall Survival|Number of months of survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.||||||
1338648|NCT01960387|Primary|Complete Clinical Response|Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10^9/l, a platelet count greater than or equal to 100 x 10^9/l, and no evidence of extramedullary disease.|Between 14 and 28 days from start of study treatment|Newly diagnosed Acute Myeloid Leukemia patients who received clofarabine (1-2 hour intravenous infusion of 40mg/m2 daily dose) plus cytarabine (2-4 hours maximum intravenous infusion of 1g/m2 daily dose) starting 3-4 hours post completion of clofarabine administration on days 1 through 5, who were evaluable for response by bone marrow biopsy.|||participants|||Number
1338649|NCT01960296|Secondary|Development of Myocardial Infarction or Thrombosis||up to 90 days||||participants|||Number
1338650|NCT01960296|Secondary|Same Day Discharged|Number of patients discharged on the day of surgery|up to 90 days||||participants|||Number
1338651|NCT01960296|Secondary|Average Length of Hospital Stay||up to 90 days||||days||Standard Deviation|Mean
1338652|NCT01960296|Secondary|Average Change in Hematocrit|hematocrit levels change from preoperative to postoperative|baseline and Day 1||||percent change||Standard Deviation|Mean
1338653|NCT01960296|Secondary|Procedure Time||Day 1||||minutes||Standard Deviation|Mean
1338654|NCT01960296|Primary|Perioperative Bleeding Complications|Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.|up to 90 days postop||||participants|||Number
1338655|NCT01960296|Secondary|Procedure Estimated Blood Loss||up to 90 days postop|Quantitative estimation of blood loss was available in 31 of the 43|||mL||Standard Deviation|Mean
1338657|NCT01960140|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid|The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.|Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose|Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1338658|NCT01960140|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid|The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.|Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose|Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1338659|NCT01960114|Secondary|Patient Global Evaluation|Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent.|12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||percentage of participants|||Number
1338660|NCT01960114|Secondary|Duration of Pain Relief|Minutes until rescue medication was given.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||Minutes||95% Confidence Interval|Median
1338661|NCT01960114|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||Minutes||95% Confidence Interval|Median
1338662|NCT01960114|Secondary|Time to Confirmed First Perceptible Pain Relief|Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||Minutes||95% Confidence Interval|Median
1338663|NCT01960114|Primary|Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)|Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.|10 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
1338664|NCT01959945|Secondary|Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.|||percentage of participants||95% Confidence Interval|Number
1338665|NCT01959945|Secondary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.|||percentage of participants||95% Confidence Interval|Number
1338666|NCT01959945|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.|Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.|||titer||95% Confidence Interval|Geometric Mean
1338667|NCT01959945|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.|Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.|Day 0 up to Day 28 post vaccination||||participants|||Number
1338668|NCT01959932|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
1338669|NCT01959932|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1338670|NCT01959932|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||ng/mg creat||95% Confidence Interval|Least Squares Mean
1338671|NCT01959932|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
1338672|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1338673|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1338674|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1338675|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1338676|NCT01959685|Primary|Cmax of a Single Dose of 250 mg Androxal||24 hours|Safety population|||ng/dL||Standard Deviation|Mean
1338677|NCT01959685|Primary|Pharmacokinetics|Cmax of a single dose 125 mg of Androxal|24 hrs|Safety population|||ng/dL||Standard Deviation|Mean
1338678|NCT01959607|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng*h/mL||95% Confidence Interval|Least Squares Mean
1338679|NCT01959607|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
1338680|NCT01959581|Primary|Change in Time Contacting Objects|Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.|7 months|infants born with significant brain injury and toddlers with a diagnosis of arthrogryposis multiplex congenita|||percentage of time||Standard Deviation|Mean
1338681|NCT01959529|Secondary|Change in Glycosylated Haemoglobin (HbA1c)|Mean change in HbA1c from week 0 to month 24.|Randomisation to 24 months|The analysis was based on the FAS. The number of subjects analysed are the number of subjects with the available data after 24 months.|||percentage of HbA1c||Standard Deviation|Mean
1338682|NCT01959529|Secondary|Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)|Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.|From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)|The analysis was based on the FAS, which included all randomised subjects.|||Participants|||Count of Participants
1338696|NCT01959412|Secondary|Change From Period Baseline in Trough FEV1 (L)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
1338683|NCT01959529|Secondary|Number of EAC-confirmed Severe Hypoglycaemic Episodes|Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.|From randomisation to individual end of trial (maximum patient year observation: 2.75 years)|The analysis was based on the FAS, which included all randomised subjects.|||Number of severe episodes|||Number
1338684|NCT01959529|Primary|Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.|From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)|The analysis was based on the FAS, which included all randomised subjects.|||Participants|||Count of Participants
1338685|NCT01959516|Secondary|Comparison of Glycopyrronium QD Versus Tiotropium QD on Symptoms Outcome|"Comparison of symptoms outcome between glycopyrronium QD versus tiotropium QD will be conducted via the PROMorning COPD Symptoms questionnaire. This questionnaire will be completed by participants at waking-up, pre-inhalation of study treatment (at home), and they will complete Part 2 of PRO-Morning COPD Symptoms questionnaire at site, 3hours post-inhalation of study treatment. The PRO-Morning COPD Symptoms Questionnaire is a self-administered patient reported outcome (PRO) instrument developed by the sponsor to evaluate patients' experience of early morning symptoms of COPD. The questionnaire consists of two parts : predose and postdose.~Each part has 6 questions and for each question a scale of 0 to 10 can be reached. For the predose and postdose part of the questionnaire you will have then each a total score of 0-60 by adding the sub-scores for each question, higher scores represent worse severity of COPD morning symptoms"|day 1 (baseline) and week 4|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1338686|NCT01959516|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-4h After First Dose of Treatment.|Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) will measured via spirometry and calculated from 0 to 4 hours post-dose on day 1 of study treatment.|Day 1|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1|||Liters*hours||95% Confidence Interval|Least Squares Mean
1338687|NCT01959503|Secondary|Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days||30 days post procedure|One subject in Progel Vascular Sealant and one subject in Gelfoam Plus discontinue before 30days and do not have device-related SAE. They are considered as not evaluable and are not included in this analysis, thus makes the difference compared to population in baseline.|||participants|||Number
1338688|NCT01959503|Secondary|Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.||30 days post procedure||||participants|||Number
1338689|NCT01959503|Secondary|Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.||Intra-procedurally|In the Vascular group two subjects were not evaluable as information was not collected for this endpoint, which changes the number from 106 to 104, compare to baseline characteristics.|||minutes||Standard Deviation|Mean
1338690|NCT01959503|Secondary|Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.|||participants|||Number
1338691|NCT01959503|Secondary|Chest Tube Drainage Volume Following Surgery.||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.|||mL||Standard Deviation|Mean
1338692|NCT01959503|Secondary|Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||0 seconds to 10 minutes||||percentage of participants|||Number
1338693|NCT01959503|Secondary|Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||5 minutes after application|In the Progel group one subject was not evaluable as information was not collected for this endpoint, which change the number from 106 to 105, compare to baseline characteristics.|||percentage of participants|||Number
1338694|NCT01959503|Primary|Time to Achieve Hemostasis at the Aortic Anastomotic Suture Line From the Time Surgical Clamps Are Released to Cessation of Leakage at the Treated Anastomotic Site With Either Progel or Gelfoam.||0 seconds to 600 seconds|In the Progel group one subject was not evaluable as information was not collected for the primary end-point changing the number from 106 to 105, compare to baseline characteristics.|||seconds||Standard Deviation|Mean
1338695|NCT01959412|Secondary|Change From Period Baseline in FVC (L) AUC (0-24h)|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
1339232|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338697|NCT01959412|Secondary|Change From Period Baseline in Peak FEV1 (L)|Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
1338698|NCT01959412|Secondary|Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.|Day 1 (12 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||liters||Standard Error|Least Squares Mean
1338699|NCT01959412|Primary|Change From Period Baseline in FEV1 (L) AUC(0-24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.|Day 1 (24 hours)|drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
1338700|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.|Week 12|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 12, the analysis for the number of patients categorised as sexually dysfunctional was based on the 82 patients who had a measure for this outcome|||participants|||Number
1338701|NCT01959035|Secondary|Change From Baseline to Week 12 in ASEX Total Score|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for ASEX total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338702|NCT01959035|Secondary|Change From Baseline to Week 12 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for WoRQ total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338703|NCT01959035|Secondary|Change From Baseline to Week 12 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for TooL total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338704|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Instrumental Role' QLS domain score was based on the 81 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338730|NCT01958827|Other Pre-specified|Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Baseline (Week 0) to Week 52|FAS|||participants|||Number
1338705|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Interpersonal Relations' QLS domain score was based on the 82 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338706|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 82 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338707|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Common Objects and Activities' QLS domain score was based on the 82 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338708|NCT01959035|Secondary|Change From Baseline to Week 12 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for QLS total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338709|NCT01959035|Secondary|Change From Baseline to Week 12 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for CGI-S score was based on the 83 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338710|NCT01959035|Secondary|Change From Baseline to Week 12 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for SWN-S total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338711|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.|Week 24|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 24, the analysis for the number of patients categorised as sexually dysfunctional was based on the 75 patients who had a measure for this outcome|||participants|||Number
1339233|NCT01953328|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1338712|NCT01959035|Secondary|Change From Baseline to Week 24 in ASEX Total Score|The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient’s recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for ASEX total score was based on the 75 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338713|NCT01959035|Secondary|Change From Baseline to Week 24 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient’s ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for WoRQ total score was based on the 77 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338714|NCT01959035|Secondary|Change From Baseline to Week 24 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for TooL total score was based on the 75 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338715|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Instrumental Role' QLS domain score was based on the 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338716|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Interpersonal Relations' QLS domain score was based on the 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338717|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338718|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Common Objects and Activities' QLS domain score was based 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
1338760|NCT01958645|Secondary|Change From Baseline Endogenous Thrombin Potential (ETP)|For the baseline variables and adverse events the two placebo arms (placebo dose 1 and placebo dose 2) are recorded as one. For the secondary outcome measures the two placebo arms are recorded separately.|Predose and Days 1-5||||nM*min||Standard Deviation|Mean
1338719|NCT01959035|Secondary|Change From Baseline to Week 24 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for QLS total score was based on the 78 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338720|NCT01959035|Secondary|Change From Baseline to Week 24 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for CGI-S score was based on the 78 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338721|NCT01959035|Secondary|Change From Baseline to Week 24 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for SWN-S total score was based on the 75 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
1338722|NCT01959035|Primary|Safety and Tolerability|Number of treatment emergent adverse events (TEAEs).|Up to 24 weeks and 4-week safety follow up|Safety data is based on all patients who received at least one dose of investigational medicinal product (IMP) in Study 14724B.|||number of events|||Number
1338723|NCT01958827|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.~For more details on adverse events please see the AE section below."|60 weeks|Safety Analysis Set|||participants|||Number
1338724|NCT01958827|Secondary|Body Temperature: Mean Change From Baseline (Week 0) to Each Visit|n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||degrees Celcius||Standard Deviation|Mean
1338725|NCT01958827|Secondary|Heart Rate: Mean Change From Baseline (Week 0) to Each Visit|Heart rate was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||bpm||Standard Deviation|Mean
1338726|NCT01958827|Secondary|Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||mm Hg||Standard Deviation|Mean
1338727|NCT01958827|Secondary|Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||mm Hg||Standard Deviation|Mean
1338728|NCT01958827|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters|Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|52 weeks|Safety Analysis Set|||participants|||Number
1338729|NCT01958827|Secondary|Number of Participants With Potentially Significant Hematology Parameters|Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. Increase is signified by ↑. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value.|52 weeks|Safety Analysis Set: All enrolled participants who received at least one dose of study drug.|||participants|||Number
1338761|NCT01958645|Primary|Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination||From screening and up to the lab follow-up visit (Day 29)||||Participants|||Number
1339234|NCT01953328|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1338731|NCT01958827|Other Pre-specified|Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method. The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha. n=the number of participants with available data at each time point.|Baseline (Week 0) to Week 52|All participants in the FAS with available data at both time points.|||µg/mL||Standard Deviation|Mean
1338732|NCT01958827|Secondary|C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||mg/dL||Standard Deviation|Mean
1338733|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
1338734|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
1338735|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. Week 8 was the primary outcome measure.|Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
1338736|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
1338737|NCT01958827|Primary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Week 8|Full Analysis Set (FAS): All enrolled participants who received at least one dose of study drug and had at least one post-treatment efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1338738|NCT01958788|Secondary|Beck Depression Inventory, 2nd Edition (BDI-II)|The BDI-II is a self-report questionnaire assessing a variety of depressive symptoms, including low mood, anhedonia, and worthlessness. Scores range from 0 to 63, with greater scores indicating greater depressive symptoms. The BDI-II was used to evaluate change from baseline in self-reported depressive symptoms.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
1338739|NCT01958788|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self-report questionnaire assessing affective, cognitive, and somatic anxiety over the preceding week. Scores range from 0 to 63, with greater scores representing greater self-reported anxiety. The BAI was used to evaluate change from baseline in self-reported anxiety.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
1338740|NCT01958788|Secondary|GAD Safety Behaviours Questionnaire (GAD-SBQ)|The GAD-SBQ is a self-report questionnaire assessing the tendency to use safety behaviours to cope with anxiety, such as reassurance-seeking and overpreparation. Scores range from 18 to 90, with greater scores indicating greater use of safety behaviours. The GA-SBQ was used to evaluate change from baseline in self-reported safety behaviours.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
1338741|NCT01958788|Secondary|Penn State Worry Questionnaire (PSWQ)|The PSWQ is a self-report questionnaire assessing excessive and uncontrollable worry. Scores range from 16 to 80, with greater scores indicating greater worry. The PSWQ was used to evaluate change from baseline in self-reported worry.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
1338742|NCT01958788|Secondary|Intolerance of Uncertainty Scale (IUS)|The IUS is a self-report questionnaire assessing intolerance of uncertainty, or the tendency to view uncertainty and its consequences as negative. Scores range from 27 to 135, with higher scores representing greater intolerance of uncertainty. The IUS was used to assess change from baseline in self-reported intolerance of uncertainty.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
1338743|NCT01958788|Secondary|Worry and Anxiety Questionnaire (WAQ)|The WAQ is a questionnaire assessing self-reported symptoms of GAD. Scores range from 0 to 56, with higher scores indicating greater severity of self-rated GAD symptoms. The measure was used to assess change from baseline in self-reported GAD symptoms (WAQ).|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
1338744|NCT01958788|Primary|Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)|The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
1338745|NCT01958671|Secondary|Change From Baseline in DBP at Week 26|The change from baseline is the Week 26 DBP minus the Week 0 DBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline DBP measurement or at least 1 post-randomization DBP measurement subsequent to at least 1 dose of study treatment.|||mmHg||95% Confidence Interval|Least Squares Mean
1338746|NCT01958671|Secondary|Baseline Sitting Diastolic Blood Pressure (DBP)|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in DBP at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline DBP measurement.|||mmHg||Standard Deviation|Mean
1338747|NCT01958671|Secondary|Change From Baseline in SBP at Week 26|The change from baseline is the Week 26 SBP minus the Week 0 SBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline SBP measurement or at least 1 post-randomization SBP measurement subsequent to at least 1 dose of study treatment.|||mmHg||95% Confidence Interval|Least Squares Mean
1338748|NCT01958671|Secondary|Baseline Sitting Systolic Blood Pressure (SBP)|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in SBP at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline SBP measurement.|||mmHg||Standard Deviation|Mean
1338749|NCT01958671|Secondary|Change From Baseline in 2-hr PPG at Week 26|The change from baseline is the Week 26 2-hr PPG minus the Week 0 2-hr PPG. Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the MMTT. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline 2-hr PPG measurement or at least 1 post-randomization 2-hr PPG measurement subsequent to at least 1 dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1338750|NCT01958671|Secondary|Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level|Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the Mixed Meal Tolerance Test (MMTT). Change from baseline in 2-hr PPG level at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline 2-hr PPG measurement.|||mg/dL||Standard Deviation|Mean
1338751|NCT01958671|Secondary|Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.|||Percentage of participants|||Number
1338752|NCT01958671|Secondary|Change From Baseline in Body Weight at Week 26|The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline body weight measurement or at least 1 post-randomization body weight measurement subsequent to at least 1 dose of study treatment.|||Kilograms||95% Confidence Interval|Least Squares Mean
1338753|NCT01958671|Secondary|Change From Baseline in FPG at Week 26|The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of glycemic rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline FPG measurement or at least 1 post-randomization FPG measurement subsequent to at least 1 dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1338754|NCT01958671|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to 52 weeks|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.|||Percentage of participants|||Number
1338755|NCT01958671|Primary|Percentage of Participants Experiencing An Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to 54 weeks (including 2 weeks following last dose)|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.|||Percentage of participants|||Number
1338756|NCT01958671|Primary|Change From Baseline In A1C at Week 26|A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
1338757|NCT01958645|Secondary|Change From Baseline D-dimer Concentration||predose and 1-8 hours||||mg/L||Standard Deviation|Mean
1338758|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by Clot Assay||Predose and 1-8 hours||||% (concentration)||Standard Deviation|Mean
1338759|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by ECL Assay||Predose and 1-8 hours||||umol/L||Standard Deviation|Mean
1338762|NCT01958619|Secondary|Piperaquine AUC0-∞|Piperaquine Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1338763|NCT01958619|Secondary|Piperaquine Cmax|Piperaquine Observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1338764|NCT01958619|Primary|OZ439 AUC0-∞|OZ439 Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1338765|NCT01958619|Primary|OZ439 Cmax|OZ439 observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1338766|NCT01958606|Other Pre-specified|Change in Stroke Impact Scale|Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition.|Baseline and 4 weeks||||units on a scale from 0-100||Standard Deviation|Mean
1338767|NCT01958606|Other Pre-specified|Change in Daily Physical Activity (Activity Monitor)||Baseline and 4 weeks|measure not used||||||
1338768|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition|Before and after training session 12|measure not used||||||
1338769|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition|Before and after training session 2|measure not used||||||
1338770|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition|Baseline and 4 weeks|measure not used||||||
1338771|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics During Session 1|3D motion capture and force plates|During session 1|measure not used||||||
1338772|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics From Baseline to Post Session 1|3D motion capture and force plates|Baseline and after session 1|measure not used||||||
1338773|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks|3D motion capture and force plates|Baseline and 4 weeks|Measure not used||||||
1338774|NCT01958606|Other Pre-specified|Change in Montreal Cognitive Assessment||Baseline and 4 weeks|Measure not used||||||
1338775|NCT01958606|Other Pre-specified|Change in Self-Efficacy and Outcome Expectations for Exercise Scale||Baseline and 4 weeks|Outcome measure not used||||||
1338776|NCT01958606|Secondary|Change in Fractional Utilization|Metabolic cost of gait as a percentage of aerobic capacity|Baseline and 4 weeks|Subjects with available data|||percentage of aerobic capacity||95% Confidence Interval|Mean
1338777|NCT01958606|Secondary|Change in Fastest Treadmill Speed (Steep Ramp Test)|fastest safe treadmill walking speed|Baseline and 4 weeks||||meters per second||95% Confidence Interval|Mean
1338778|NCT01958606|Secondary|Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)|mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter|Baseline and 4 weeks|Subjects with available data|||mLO2/kg/m||95% Confidence Interval|Mean
1338779|NCT01958606|Secondary|Change in 6-Minute Walk Test|distance walked in 6 minutes|Baseline and 4 weeks||||meters||95% Confidence Interval|Mean
1338780|NCT01958606|Secondary|Change in Gait Velocity (10 Meter Walk Test)||Baseline and 4 weeks||||m/s||95% Confidence Interval|Least Squares Mean
1338781|NCT01958606|Secondary|Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)||Baseline and 4 weeks|ventilatory threshold was not identifiable for one participant|||ml/kg/min||95% Confidence Interval|Least Squares Mean
1338782|NCT01958606|Primary|Change in Peak Aerobic Capacity (VO2-peak)||Baseline and 4 weeks|on treatment analysis|||ml/kg/min||95% Confidence Interval|Least Squares Mean
1338783|NCT01958437|Primary|Egocentric|Number of turns correctly recalled for each egocentric environment|Outcome assessed after each of the 2 sessions|Participants from each group were excluded due to movement artifact that invalidated fMRI data.|||Correct turns||Standard Deviation|Mean
1338784|NCT01958437|Primary|Dorsal Attention Network Connectivity During Resting-state fMRI|Change in resting state functional connectivity strength between active and sham tDCS sessions. Strength is measured by Pearson r correlations between nodes, which are z-transformed, and summated.|change between active and sham tDCS sessions (<1month)|Participants from each group were excluded due to movement artifact that invalidated fMRI data.|||arbitrary units||Standard Deviation|Mean
1338785|NCT01958437|Primary|Hippocampal BOLD Signal During Task-based fMRI|BOLD signal change comparing active to sham tDCS during Allocentric navigation (i.e., active HD-tDCS > sham HD-tDCS). Activation maps thresholded at p<.01 with minimum cluster size of 5 voxels.|change between active and sham tDCS sessions (<1month)|Participants from each group were excluded due to movement artifact that invalidated fMRI data.|||Percent signal change||Standard Deviation|Mean
1338786|NCT01958437|Primary|Accuracy in Centimeters From Target Location for Allocentric|"1 active tDCS; 1 sham tDCS for each measure. Participants touched a screen (using a ELO 19 touchscreen monitor) to document the location of the landmark. The distance between the actual vs. selected location served as the dependent measure."|Outcome assessed after each of 2 sessions (estimated within 1 week of each other)|Computer errors caused missing data for a subset (n=4) of participants; those data have simply been omitted from analyses below.|||Centimeters (cm)||Standard Deviation|Mean
1338789|NCT01958281|Secondary|PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||hours||Inter-Quartile Range|Median
1338790|NCT01958281|Secondary|PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
1338791|NCT01958281|Secondary|PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
1338792|NCT01958281|Secondary|PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||1/hour||Standard Deviation|Mean
1338793|NCT01958281|Secondary|PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||1/hour||Standard Deviation|Mean
1338794|NCT01958281|Secondary|PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||1/hour||Standard Deviation|Mean
1338795|NCT01958281|Secondary|PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Tlast is defined as the time (observed time point) of Clast.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||hours||Inter-Quartile Range|Median
1338796|NCT01958281|Secondary|PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Tlast is defined as the time (observed time point) of Clast.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
1338797|NCT01958281|Secondary|PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Tlast is defined as the time (observed time point) of Clast.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||hours||Inter-Quartile Range|Median
1338798|NCT01958281|Secondary|PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Tmax is defined as the time (observed time point) of Cmax.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||hours||Inter-Quartile Range|Median
1338799|NCT01958281|Secondary|PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Tmax is defined as the time (observed time point) of Cmax.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
1338800|NCT01958281|Secondary|PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Tmax is defined as the time (observed time point) of Cmax.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||hours||Inter-Quartile Range|Median
1338801|NCT01958281|Secondary|PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Clast is defined as the last observable concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1338802|NCT01958281|Secondary|PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Clast is defined as the last observable concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1338803|NCT01958281|Secondary|PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Clast is defined as the last observable concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||ng/mL||Standard Deviation|Mean
1338804|NCT01958281|Secondary|PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|AUClast is defined as the concentration of drug from time zero to the last observable concentration.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1338805|NCT01958281|Secondary|PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|AUClast is defined as the concentration of drug from time zero to the last observable concentration.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1339235|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338806|NCT01958281|Secondary|PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|AUClast is defined as the concentration of drug from time zero to the last observable concentration.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||h*ng/mL||Standard Deviation|Mean
1338807|NCT01958281|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1338808|NCT01958281|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR4 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1338809|NCT01958281|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1338810|NCT01958281|Primary|PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1338811|NCT01958281|Primary|PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1338812|NCT01958281|Primary|PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||ng/mL||Standard Deviation|Mean
1338813|NCT01958281|Primary|PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Cmax is defined as the maximum concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1338814|NCT01958281|Primary|PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Cmax is defined as the maximum concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1338815|NCT01958281|Primary|PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Cmax is defined as the maximum concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||ng/mL||Standard Deviation|Mean
1338816|NCT01958281|Primary|PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1338817|NCT01958281|Primary|PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1338818|NCT01958281|Primary|Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set (all enrolled participants who took at least 1 dose of study drug and have at least 1 nonmissing postdose PK concentration value) from Cohorts 1 and 2 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1338819|NCT01958281|Primary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1338820|NCT01958281|Primary|Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1338821|NCT01958281|Primary|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days.|Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1338822|NCT01958281|Primary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1338823|NCT01958281|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1339094|NCT01955083|Secondary|Percent Change in Total-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Imean||Standard Error|Mean
1338824|NCT01958164|Secondary|Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.|This endpoint was defined as the number of doses required to achieve restored CVAD function in patients from the actilyse treatment group but was analysed as the percentage of participants who achieved restored CVAD function after 1 dose and 2 doses, in patients from the actilyse treatment group.|0 minutes and 240 minutes|All patients in the FAS who were randomised to the Actilyse treatment group|||percentage of participants|||Number
1338825|NCT01958164|Secondary|Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0)|240 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration|||percentage of participants||95% Confidence Interval|Number
1338826|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0)|150 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration|||percentage of participants||95% Confidence Interval|Number
1338827|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0|Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution)|30 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1338828|NCT01958164|Primary|Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication|Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).|120 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1338829|NCT01958060|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS)|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1338830|NCT01958060|Secondary|AUC0-inf|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).~AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial."|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS):|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1338831|NCT01958060|Secondary|Cmax|Maximum measured concentration of BI 1034020 in plasma (Cmax).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic Set (PKS): This subject set included all subjects in the treated set who provide at least 1 observation for at least 1 secondary Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1338832|NCT01958060|Primary|Percentage of Subjects With Drug Related Adverse Events|Percentage of subjects with investigator defined drug-related adverse events|from the first drug administration to end of trial, up to 50 days|Treated Set (TS)|||percentage of participants|||Number
1338833|NCT01958021|Secondary|QTc Interval|Time between the start of the Q wave and the end of the T wave corrected for heart rate|Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1|||||||
1338834|NCT01958021|Secondary|Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30|The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.|Up to approximately 20 months|||||||
1338835|NCT01958021|Secondary|Safety and Tolerability of LEE011|Safety will be determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03.|Up to approximately 21 months|||||||
1338836|NCT01958021|Secondary|Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score|Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.|Up to approximately 20.5 months|||||||
1338837|NCT01958021|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1.|Up to approximately 20 months|||||||
1338838|NCT01958021|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death from any cause.|Up to approximately 65 months|||||||
1338839|NCT01958021|Secondary|Overall Response Rate (ORR) as Per Investigator Assessment|Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|Up to approximately 20 months|The Full Analysis Set (FAS- population) consisted of all randomized patients.|||percentage of participants||95% Confidence Interval|Number
1338840|NCT01958021|Primary|Progression Free Survival (PFS) Per Investigator Assessment|PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1|Up to approximately 20 months|The Full Analysis Set (FAS- population) consisted of all randomized patients.|||months||95% Confidence Interval|Median
1338841|NCT01958008|Secondary|R(A,AUC)|R(A,AUC) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||ratio||Geometric Coefficient of Variation|Geometric Mean
1338842|NCT01958008|Secondary|R(A,Cmax)|R(A,Cmax) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||ratio||Geometric Coefficient of Variation|Geometric Mean
1338843|NCT01958008|Secondary|T1/2,ss|T1/2,ss (terminal half life of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||hours||Geometric Coefficient of Variation|Geometric Mean
1338844|NCT01958008|Secondary|Tmax,ss|Tmax,ss (time from last dosing to maximum concentration of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||hours||Full Range|Median
1338845|NCT01958008|Secondary|AUC Tau,ss|AUC tau,ss (area under the concentration-time curve of the BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1338846|NCT01958008|Secondary|Cmax,ss|Cmax,ss (maximum measured concentration of BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|Pharmacokinetic set (PKS): The patient set for the evaluation of PK endpoints included all evaluable patients in the treated set which provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1338847|NCT01958008|Primary|Number (%) of Patients With Drug-related Adverse Events (AEs)|Number (%) of patients with drug-related adverse events (AEs)|AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)|Treated set (TS)|||percentage of participants|||Number
1338848|NCT01957930|Secondary|Microvascular Endothelial Function|Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response.|2 months||2015-11-30|11/2015||||
1338849|NCT01957930|Primary|Ischemic Foot Ulcer|The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code|Until hospitalization for ischemic foot ulcer or until 31 December 2011||||participants|||Number
1338850|NCT01957865|Secondary|HIV RNA Suppression|HIV RNA suppression (<100 copies/ml) in each study arm|After month 9|Note: Missing data equals lack of suppression. The participant found to be HIV negative was not included in the analysis.|||number of participants|||Number
1338851|NCT01957865|Primary|Antiretroviral Therapy (ART) Adherence Levels|ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.|real time (for 9 months)|The participant found to be HIV negative was not included in the analysis.|||Percent adherence||Standard Deviation|Mean
1338852|NCT01957761|Primary|Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis|Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.|On day 1 of diagnosis of Clostridium difficile infection||||cases of BI/NAP1/027|||Number
1338853|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338877|NCT01957579|Secondary|Maximum Tolerated Dose|A dose was considered non-tolerated and dose escalation stopped if ≥2 of up to 6 evaluable patients experienced a DLT at any dose level. MTD is the last dose level before the non-tolerated dose.|From baseline to 28 days after the first dose of study drug|All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.|||mg/kg|||Number
1339236|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1338854|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338855|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338856|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338857|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338858|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338859|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338860|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338861|NCT01957657|Secondary|Number (%) of Subjects With Drug-related Adverse Events|Number (percentage) of subjects with drug-related adverse events|From the first drug administration until last drug administration, up to 10 days|Treated set (TS) included all enrolled subjects, who had taken at least one dose of trial medication.|||percentage of participants|||Number
1338862|NCT01957657|Primary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined||||||
1338863|NCT01957657|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
1338864|NCT01957579|Secondary|Number of Participants With Tumour Response in MM Patients|"Tumour response is defined as complete response (CR) or partial response (PR) (Durie M et al 2006).~CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24 h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."|From the baseline to30 days after the last dose of study drug|All patients with MM who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
1338865|NCT01957579|Secondary|Number of Participants With Tumour Response in CLL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Hallek M et al 2008).~CR: all of the following criteria have to be met, and patients have to lack disease-related constitutional symptoms; Lymphadenopathy: None; Hepatomegaly: None; Splenomegaly: None; Blood lymphocytes: <4000/μL; Marrow: Normocellular, <30%lymphocytes, no B-lymphoid nodules, hypocellular marrow defines CR with incomplete marrow recovery; Platelet count: >100000/μL; Hemoglobin: >11.0 g/dL; Neutrophils: >1500/μL PR: at least 2 of the criteria of group A plus 1 of the criteria of group B have to be met.~Group A: Lymphadenopathy: Decrease ≥50%; Hepatomegaly: Decrease ≥50%; Splenomegaly: Decrease ≥50%; Blood lymphocytes: Decrease ≥50% from baseline; Marrow: 50% reduction in marrow infiltrate, or B-lymphoid nodules.~Group B: Platelet count: 100000/μL or increase ≥50% over baseline; Hemoglobin: >11.0 g/dL or increase ≥50% over baseline; Neutrophils: >1500/μL or >50% improvement over baseline."|From the baseline to 30 days after the last dose of study drug|All patients with CLL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
1338866|NCT01957579|Secondary|Number of Participants With Tumour Response in DLBCL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).~CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.~PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified."|From the baseline to 30 days after the last dose of study drug|All patients with DLBCL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
1338867|NCT01957579|Secondary|Number of Participants With Tumour Response in FL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).~CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.~PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified."|From the baseline to 30 days after the last dose of study drug|All patients with FL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
1338868|NCT01957579|Secondary|Anti-MEDI-551 Antibodies|Only 1 patient was tested positive for ADA at pre-dose of Cycle 1 Day 1. However, it was considered as false-positive because the titer value was close to the cut point, and this patient was tested negative for ADA at all subsequent cycles post-baseline.|From baseline to 30 days after the last dose of study drug|Patients who have at least one post-baseline sample for Anti-MEDI-551 antibodies.|||Participants|||Number
1338869|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 168|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 168|Patients who have trough concentration data at Day 168|||μg/mL||Standard Deviation|Mean
1338870|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 140|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 140|Patients who have trough concentration data at Day 140|||μg/mL||Standard Deviation|Mean
1338871|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 112|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 112|Patients who have trough concentration data at Day 112|||μg/mL||Standard Deviation|Mean
1338872|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day84|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 84|Patients who have trough concentration data at Day 84|||μg/mL||Standard Deviation|Mean
1338873|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 56|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 56|Patients who have trough concentration data at Day 56|||μg/mL||Standard Deviation|Mean
1338878|NCT01957579|Secondary|Number of Participants With Dose Limiting Toxicities|A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident.|From baseline to 28 days after the first dose of study drug|All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.|||Participants|||Number
1338879|NCT01957579|Primary|Number of Participants With Adverse Events||From baseline to 30 days after the last dose of study drug|All patients who received at least 1 dose of MEDI-551.|||Participants|||Number
1338880|NCT01957553|Primary|Preference|The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.|21+1 days|The ITT population was constituted by all randomized subjects with valid informed consent who had applied at least one test product and had valid information for the primary endpoint preference, or valid information for at least one product with respect to one of the secondary endpoints., who included all subject who contributed with endpoint data|||percentage of participants|||Number
1338881|NCT01957488|Primary|Leakage|The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14 +- 1 days||||percentage of baseplates|Participants||Number
1338882|NCT01957475|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome).~The degree of leakage was measured at each baseplate change."|14 days||||units on a scale|Participants|Standard Deviation|Mean
1338883|NCT01957462|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome).~The degree of leakage is measured at each baseplate change"|14 days||||units on a scale|Participants|Standard Deviation|Mean
1338884|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1|MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles. The Motor Evoked Response to Transcranial Magnetic Stimulation (TMS MEPs) was evaluated at baseline and regularly after study drug administration. Intracortical inhibition and facilitation was also evaluated using TMS. A figure-of-eight coil with external loop diameters of 9 cm was used to elicit motor responses in the contralateral first dorsal interosseus.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of MEP.|||mV||Standard Deviation|Mean
1338885|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1|SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 64-channel EEG system at baseline (predose) and regularly after study drug administration. The change from baseline was calculated as post-baseline value minus baseline value for each participant. Since the number of participants at baseline differ from the number of participants at post-baseline measure (that is [i.e.] not all baseline values are paired), the mean change is not equal to the difference between the means at the two time points.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of SEP (P40).|||millivolts (mV)||Standard Deviation|Mean
1338886|NCT01957397|Primary|Degree of Leakage|The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)|14 days||||units on a scale|Participants|Standard Deviation|Mean
1338887|NCT01957384|Primary|Degree of Leakage|The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S|Up to 14 days per test product||||units on a scale|Participants|Standard Deviation|Mean
1338888|NCT01957215|Secondary|Total Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Dose||Full Range|Median
1338889|NCT01957215|Secondary|Time to First Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Days||95% Confidence Interval|Median
1338890|NCT01957215|Secondary|Rate of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Number of participants|||Number
1338891|NCT01957215|Secondary|Patients' Global Assessment to Treatment|Patients global assessment in response to treatment was measured at the end of the study on a scale of 0 to 4 where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
1338908|NCT01957137|Secondary|Number of Pads Used Per Day - no Stimulation|Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Pad use / day||Standard Deviation|Mean
1339237|NCT01953237|Primary|Adherence to Antipsychotic Medications||3 month period||||percentage of days adherent||Standard Deviation|Mean
1338892|NCT01957215|Secondary|Total Pain Relief (TOTPAR) on Movement|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, baseline), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (time t – time t-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Mean
1338893|NCT01957215|Secondary|Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement|"SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point.~SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time; 0 hr (Day 1, pre treatment), 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr, respectively.~PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [based on NRS which is a horizontal line with a scale from 0-10. where 0 represents “No” and 10 represents the “worst possible pain”]. NR scores were converted into PID scores by subtracting them from baseline pain scores.~PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]"|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
1338894|NCT01957215|Secondary|Assessment of Sum of Pain Intensity Difference (SPID) on Movement|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).~Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents “No” and 10 represents the “worst possible pain”."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
1338895|NCT01957215|Secondary|Time to Onset of Pain Relief|"Time to onset of pain relief was measured by the time to reach a pain relief score of 1 (“A little or perceptible pain relief”)."|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Days||Full Range|Median
1338896|NCT01957215|Secondary|Change From Baseline in NRS at Rest|Mean changes in pain intensity at each time point at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups at time points 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs was measured using NRS. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), participants were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
1338897|NCT01957215|Secondary|NRS for Pain on Movement Over Time|"NRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.~The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), patients were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain."|30 mins to 144 hr post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Deviation|Mean
1338898|NCT01957215|Secondary|Pain Relief Score (PRS) on Movement Over Time|"PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.~Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score."|30 minutes (mins) to 144 hours (hrs) post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.|||Score on scale||Standard Deviation|Mean
1338899|NCT01957215|Primary|Sum of Pain Intensity Difference (SPID)1-3 Days|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).~Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents “No” and 10 represents the “worst possible pain”"|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on the Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
1340694|NCT01935947|Other Pre-specified|Response to Therapy Compared to Genetic and Epigenetic Factors and Tested for Association||After 1 month of therapy|Data was not collected to assess this outcome measure due to early study termination.||||||
1338900|NCT01957202|Secondary|Weighted Mean of the Total Ocular Symptom Score (TOSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes , each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes). TOSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TOSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|PD Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1338901|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Ocular Symptom Score (TOSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TOSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes).|Day 1 of each treatment period (up to 80 days)|PD Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1338902|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Nasal Symptom Score (TNSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TNSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]).|Day 1 of each treatment period (up to 80 days)|PD Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1338903|NCT01957202|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of investigational product) and who also provided data from at least one PD assessment. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1338904|NCT01957163|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1338905|NCT01957163|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1338906|NCT01957137|Secondary|Adverse Events - no Stimulation|Summary of adverse device effects when subjects were under no stimulation is provided. Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented.|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Percent of Subjects|||Number
1338907|NCT01957137|Secondary|Global Response Assessment - no Stimulation|Summary of GRA under no stimulation setting is provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject’s entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Percent of Subjects|||Number
1338909|NCT01957137|Secondary|Degree of Urgency - no Stimulation|Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|28 subjects who received no stimulation were included in the analysis.|||units on a scale||Standard Deviation|Mean
1338910|NCT01957137|Secondary|Number of UUI Episodes Per Day - no Stimulation|UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Number of UUI episodes/ Day||Standard Deviation|Mean
1338911|NCT01957137|Secondary|Global Response Assessment (GRA) - Randomized Portion|"Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject’s entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).~Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented."|4 weeks|24 subjects who first completed unique randomization sequences were included in the analysis.|||Percent of Subjects|||Number
1338912|NCT01957137|Secondary|Number of Pads Used Per Day - Randomized Portion|Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|24 subjects who first completed unique randomization sequences were included in the analysis.|||Pads per day||95% Confidence Interval|Least Squares Mean
1338913|NCT01957137|Secondary|Degree of Urgency - Randomized Portion|Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 week|24 subjects who first completed unique randomization sequences were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1338914|NCT01957137|Primary|Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion|Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|24 subjects who first completed the unique randomization sequences were included in the analysis.|||Number of UUI episodes/ Day||Standard Deviation|Mean
1338915|NCT01957111|Secondary|Sleep Efficiency Percentage on Overnight Sleep Study|Participants will have their sleep measured with polysomnography for one night. The sleep of individuals with insomnia will be compared to that of good sleepers. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed.|1 night||||% sleep efficiency||Standard Deviation|Mean
1338916|NCT01957111|Primary|Number of Metabolites Elevated Relative to the Other Group.|Metabolomics analysis of blood samples were carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. A total of 70 metabolites were measured and compared between individuals with insomnia and good sleepers.|48 hours||||Number of metabolites elevated|||Number
1338917|NCT01956435|Secondary|Subject Self-reported Assessment of Re-pigmentation for Treated Lesions|Subject reported level of re-pigmentation for treated lesions was assessed by improvement from baseline using a scale from 1 - 4 with 1 being the least amount of re-pigmentation and 4 being the most re-pigmentation: 1 = Worsening of the light spots that were treated (the light spots seem to have gotten lighter or I have more light spots in the areas that were treated); 2 = No Improvement of the light spots (light spots have not changed since starting this study); 3 = Mild improvement of the light spots (there is some darkening of the light spots, but not in more than half of them); 4 = Moderate improvement (there is some darkening of the light spots in more than half of the light spots, but not more than 75% of them).|12 weeks|healthy adult patients with bilateral IGH lesions on lower extremities|||units on a scale||Standard Deviation|Mean
1338918|NCT01956435|Primary|Efficacy Outcome|Effectiveness will be graded by the blinded observer scal via photographic comparisons at the end of the study. Efficacy was assessed by improvement from baseline using the following scale: -1 = Worsening of IGH; 0 = No Improvement (IGH remained stable); 1 = Mild improvement of IGH (some re-pigmentation on <50% IGH); 2 = Moderate improvement (some re-pigmentation on >50% or full re-pigmentation on <75% IGH); 3 = Full re-pigmentation on >75% IGH.|12 weeks|healthy adult patients with bilateral IGH lesions on lower extremities|||units on a scale||95% Confidence Interval|Mean
1338919|NCT01956240|Secondary|Scapular Kinematics After Pectoralis Minor Stretching Protocol|The scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.|6 weeks of stretching||||degree||Standard Deviation|Mean
1338920|NCT01956240|Primary|Pectoralis Minor Length After Pectoralis Minor Stretching Protocol|The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.|6 weeks after stretching||||centimeters||Standard Deviation|Mean
1338921|NCT01956097|Secondary|Number of Participants With Adverse Events||8th weeks|"6 participants in the HX106 590mg group and 2 participant in the HX106 1180mg were dropped out."|||number of participants|||Number
1338922|NCT01956097|Secondary|Number of Participants With Adverse Events||4th weeks|"3 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."|||number of participants|||Number
1338923|NCT01956097|Secondary|Number of Participants With Adverse Events||1st week|"2 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."|||number of participants|||Number
1338924|NCT01956097|Primary|Changes From Baseline in White Matter Integrity Assessment||Baseline, 8th weeks|||||||
1338925|NCT01956097|Primary|Changes From Baseline in Working Memory Domain Z-score|"To assess the working memory performance, four well-established tests, including the symbol span from the Wechsler Memory Scale-IV, immediate recall domain from the Rey-Osterrieth Complex Figure Test, digit span, and letter number sequencing from the Korean version of the Wechsler Adult Intelligence Scale were chosen.~Each test score was adjusted with age, sex, intelligent quotient, years of education, and baseline test scores. The adjusted test scores were then standardized into z-scores using all participants' means and standard deviations. The relative improvement (positive z-scores) or decline (negative z-scores) in performance was measured in a unit-free manner using the obtained z-scores. The individual z-scores of each test were averaged to the composite score for working memory domain."|Baseline, 8th week||||z-score||Standard Error|Mean
1338926|NCT01956032|Secondary|Median Time Spent for Health Care Utilization Outside the TM Care Chain|The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Minutes||Full Range|Median
1338927|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Number of participants|||Number
1338928|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Number of participants|||Number
1338929|NCT01956032|Secondary|Percentage of Participants With Clinical Global Impression – Improvement (CGI-I) in Parkinson’s Disease Symptoms|CGI-I was used to document the Investigator’s impression of the participant’s improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338930|NCT01956032|Secondary|DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338931|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338932|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1339012|NCT01955473|Secondary|Anti-drug Antibody Titers||Week 1 (pre-dose) up to Follow-up assessment (up to maximum 45.1 Weeks)|Anti-drug Antibody (ADA) titer could not be estimated because there were no subjects who were confirmed to have ADA positive test results during the confirmatory analysis.||||||
1338933|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘more’, ‘equal’ or ‘less’ for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where ‘more’ indicated the most negative answer and ‘less’ indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338934|NCT01956032|Secondary|Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as ‘yes’ or ‘no’ for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338935|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338936|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338937|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338938|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338939|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1341866|NCT01923480|Secondary|Plasma Concentration of Isoleucine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1338940|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338941|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338942|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338943|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338944|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as ‘yes’ or ‘no’ for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338945|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident’ and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338946|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as ‘yes’ or ‘no’ for question number 14 (Where you able to perform daily activities during the titration period?) where ‘yes’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1339095|NCT01955083|Secondary|Percent Change in Total-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Imax||Standard Error|Mean
1338947|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant’s Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant’s home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338948|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as ‘yes’ or ‘no’ for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where ‘No’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338949|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure’ and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338950|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident’ and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338951|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician’s Visits to Set up and Dismantle the TM Equipment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician’s visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338952|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338953|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1343118|NCT01903863|Secondary|Antithrombin Levels|Compared antithrombin levels in neonates in control versus treatment group|ECMO course (median 198 hours)||||percentage of antithrombin||Inter-Quartile Range|Median
1338954|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338955|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338956|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338957|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338958|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as ‘yes’ or ‘no’ for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where ‘yes’ indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338959|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
1338960|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of technical events|||Number
1339096|NCT01955083|Secondary|Percent Change in Total-SI After MIS|Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-SI||Standard Error|Mean
1338961|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338962|NCT01956032|Secondary|Incidence of Consequences Due to Technical Events|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of consequences|||Number
1338963|NCT01956032|Secondary|Percentage of Participants With Consequences|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338964|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of technical events|||Number
1338965|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events|Technical events were defined as: any technical event; type A: TM equipment – mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
1338966|NCT01956032|Secondary|Median Total Free Time of Participant|Participant’s daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant’s daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant’s total free time was calculated as the sum of participant’s daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Minutes||Full Range|Median
1338967|NCT01956032|Secondary|Median Total Time for Titration|The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator’s decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Minutes||Full Range|Median
1338968|NCT01956032|Primary|Median Number of Contacts|Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Number of contacts||Full Range|Median
1339097|NCT01955083|Secondary|Change in SOS Score After MIS|Change in SOS score at 3 months after radiofrequency or pillar implant were calculated.|baseline and 3 months following surgery|Twenty-eight participants completed the follow-up protocol and two participants dropped out after surgery.|||units on a scale||95% Confidence Interval|Mean
1341867|NCT01923480|Secondary|Plasma Concentration of Histidine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1338969|NCT01956032|Primary|Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant|Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.|From Baseline (Investigator’s decision to start Duodopa treatment) until End of Titration (Investigator’s decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using full analysis set (FAS), defined as all participants that started Duodopa titration.|||Minutes||Full Range|Median
1338970|NCT01955954|Secondary|Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week||Measured at 12 months post-treatment||||Participants|||Count of Participants
1338971|NCT01955954|Secondary|Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week||Measured at 2 months post-treatment||||Participants|||Count of Participants
1338972|NCT01955954|Secondary|Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week||Measured post-treatment (week-5)||||Participants|||Count of Participants
1338973|NCT01955954|Secondary|Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)|"The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.~A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as Response in this study."|Measured at 12 months post-treatment.||||Participants|||Count of Participants
1338974|NCT01955954|Secondary|Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)|"The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.~A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as Response in this study."|Measured post-treatment (week-5)||||Participants|||Count of Participants
1338975|NCT01955954|Primary|Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)|"The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.~A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as Response in this study."|Measured at 2 months post-treatment.||||Participants|||Count of Participants
1338976|NCT01955733|Secondary|The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4|This outcome measure presents percentage of patients who meet the EULAR response [good response, moderate response, or no response] [based on DAS28 improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4.|Week 48|FAS. Subjects who did not complete Week 48 are not presented.|||Percentage of patients|||Number
1338977|NCT01955733|Secondary|The Percentage of Patients Who Meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Definition of Remission [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4|"To meet the ACR/EULAR Remission criteria*, the subject needed to satisfy the following criteria:~TCJ (68 joints) < 1~SJC (66 joints) < 1~CRP < 1 milligrams per decilitre~patient global assessment < 10. The patient global assessment for the definition of ACR/EULAR Remission was defined with a visual analog scale in millimetres (0-100).** The number of subjects meeting the ACR/EULAR Remission definition at Week 48 is presented."|Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.|The FAS consisted of all patients from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or CRP) or ACR20.|||Percentage of patients|||Number
1338978|NCT01955733|Secondary|The Percentage of Patients Meeting the ACR20 [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4|"A subject has an ACR20 response if all of the following occur:~a > 20% improvement in the swollen joint count (66 joints)~a > 20% improvement in the tender joint count (68 joints)~a > 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (CRP).~The number of subjects meeting the ACR20 response criteria at Week 48 is presented."|Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.|The FAS consisted of all subjects from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or CRP) or ACR20.|||Percentage of patients|||Number
1338979|NCT01955733|Secondary|Change From Baseline in Clinical Trial 1301.1 in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 48 of Clinical Trial 1301.4|"DAS-28 (ESR)** is an index containing a 28-joint count for tenderness (TJC28), 28 joint count for swelling (SJC28), natural logarithm of ESR (inflammation) (Ln[ESR]) and a general health component (GH) which is the patient's global assessment of disease activity and was used to describe the severity of RA. The DAS28 (ESR) Score is calculated as:~DAS28(ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.70*ln(ESR) + 0.014*(GH). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2.~The mean change from baseline (in clinical trial 1301.1) at Week 48 in the DAS28 (ESR) score is presented."|Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.|The Full Analysis Set (FAS) consisted of all subjects from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or C-reactive Protein [CRP]) or American College of Rheumatology 20% response criteria (ACR20).|||Units on Scale||90% Confidence Interval|Least Squares Mean
1338980|NCT01955733|Primary|The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase|This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or worsened in severity on or after the first dose of trial medication in this extension study [1301.4] and prior to the last date of trial medication + 180 days [inclusive]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.|Week 48|Safety Randomized Analysis Set (SAFRD): All subjects randomized in 1301.1 [excluding open-label safety run-in subjects of trial 1301.1] who receive at least one dose of trial medication and subjects will be classified according to treatment received in trial 1301.1. 2 subjects from 1301.1 safety run-in also received treatment in 1301.4, thus 88.|||Percentage of patients|||Number
1338981|NCT01955720|Secondary|Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)|"Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h).~PK Urine sampling time:~Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h."|from 0 to 6 hours of post Ida dose (details in description)|PKS-Ida: The PKS-Ida included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.|||umol||Geometric Coefficient of Variation|Geometric Mean
1338982|NCT01955720|Secondary|Cmax (Maximum Measured Concentration of the Ida in Plasma)|"Cmax. PK/PD sampling time: (p=predose, D=day)~single medium or high dose, HS mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.~single low or high dose, healthy elderly or mild RI: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8: 9:00;D9: 9:00.~high 2 doses, moderate RI: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8:9:00; D9:9:00."|From Ida administration to 4 days post dose (details in description)|PKS-Ida|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1338983|NCT01955720|Secondary|Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)|"Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state.~PK Urine sampling time:~Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.~Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years."|From 0 to 74h post of last DE dose (details in description)|Pharmacokinetic Set - DE (PKS-DE): The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.|||μg||Geometric Coefficient of Variation|Geometric Mean
1338984|NCT01955720|Secondary|AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)|"PK/PD sampling time:(d=dose,D=Day,p=predose)~single medium or high dose,healthy, mid-age (45-64 yrs): D4: 7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00, 01:00; D5:9:00p,11:00,21:00p; D6:9:00p, 21:00p; D7:9:00p, 11:00.~single low or high dose,healthy elder or mild renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00;D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.~high 2 doses, moderate renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,9:55p,10:00,10:10,10:30,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00; D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00."|from 2h to12h of post DE dose at steady state (details in description)|PKS-DE: The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1338985|NCT01955720|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC0-infinity. PK/PD sampling time: (p=predose, D=day)~single medium or high dose, healthy subjects(HS) mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.~single low or high dose, HS elderly or mild renal impaired: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8: 9:00;D9: 9:00.~high 2 doses, moderate renal impaired: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8:9:00; D9:9:00."|From Day 4 to Day 9 (details in description)|Pharmacokinetic Set -Ida (PKS-Ida): included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1338986|NCT01955720|Primary|The Percentage of Subjects With Drug-related Adverse Events|The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.|From baseline up to the start of follow-up period (from Day 1 to Day 35)|Treated Set (TS): All randomised subjects who received at least 1 dose of trial medication were included in the treated set.|||percentage of participants|||Number
1338987|NCT01955720|Primary|Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time|Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.|End of last infusion and 10 minutes after completion of last infusion of BI 655075|PD Set (PDS): The PDS included all subjects from the TS who had at least 1 evaluable predose and on-treatment coagulation test measurement value for at least 1 coagulation test and who did not have important protocol violation relevant to the evaluation of PD.|||percentage of participants|||Number
1338988|NCT01955707|Secondary|Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment.|Up to Day 90 ± 5 days|Safety population (all participants who were randomized and received any portion of the infusion of study treatment).|||participants|||Number
1338989|NCT01955707|Secondary|Barthel Index at Day 5, Day 30, and Day 90|The Barthel Index consists of 10 items that measure a person’s daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessment at given time point.|||units on a scale||Full Range|Median
1338990|NCT01955707|Secondary|Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90|The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment), using imputed data; n=number of participants with an assessment at given time point.|||participants|||Number
1338991|NCT01955707|Secondary|Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death.|Baseline, 24 hours, Day 5, Day 30, Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessments at Baseline and given time point.|||units on a scale||Standard Deviation|Mean
1338992|NCT01955707|Secondary|Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)|Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth.|Day 5, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
1338993|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)|Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
1338994|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)|Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
1338995|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
1338996|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, 24 hrs|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
1338997|NCT01955707|Primary|Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
1338998|NCT01955629|Secondary|Part 2: Aflibercept Biomarkers Evaluation|Blood and tumor samples were to be collected to evaluate proteomic biomarkers such as factors and receptors related to angiogenesis process, inflammation, and tumor progression.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned biomarker analyses was performed.||||||
1338999|NCT01955629|Secondary|Part 2: Pharmacodynamic Parameters: Modulation of Circulating Analytes|Blood and tumor samples were to be collected to evaluate the pharmacodynamic parameters including the assessment of the modulation of circulating analytes such as cytokines and angiogenic factors.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned efficacy/pharmacodynamic analyses was performed.||||||
1339000|NCT01955629|Secondary|Part 2: Number of Participants With CR or PR|Tumor assessment was performed by abdomino-pelvic computed tomography scan or MRI and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using RECIST version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Baseline and every 9 weeks up to end of study completion (15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
1339001|NCT01955629|Secondary|Part 2: Overall Rate of Resectability of Metastatic Lesions|Overall metastases resection rate was defined as the percentage of participants reaching an R0 metastases resection, defined as the complete absence of invasive carcinoma on histological examination at the time of definitive surgery.|12 months after the last participant enrolled.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
1339002|NCT01955629|Secondary|Part 2: Overall Survival (OS)|OS was defined as the time interval from the date of registration into the study to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the earliest between the last date the participant was known to be alive and the end of study date.|From the date of enrollment up to the date of death (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
1339003|NCT01955629|Secondary|Part 2: Progression Free Survival (PFS)|PFS was defined as the time interval from the date of registration into the study to the date of first observation of DP or death (due to any cause), whichever was first.|From the date of enrollment up to the date of DP or death, whichever occurred first (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
1339004|NCT01955629|Secondary|Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD])|Tumor assessment was performed by abdomino-pelvic computed tomography scan or magnetic resonance imaging (MRI) and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using response evaluation criteria in solid tumors (RECIST) version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; PD =20% increase in the sum of the LD of target lesions taking as reference the smallest sum in the study and SD = small changes that did not meet above criteria.|Baseline and every 9 weeks up to DP (up to 15 months).|Evaluable Population (EP) for tumor response was defined as a subset of ITT population (all participants who gave their informed consent and successfully registered into study) with measurable disease at study entry, who received at least 1 cycle of study treatment, with at least 1 post baseline tumor evaluation, except for early DP or death.|||Participants|||Number
1339005|NCT01955629|Primary|Part 2: Number of Participants With Progression Free Survival (PFS) at 6 Months After the Start of Maintenance Therapy|It describes the number of participants alive without progression at 6 months after the start of Aflibercept maintenance therapy.|6 months after the start of maintenance therapy.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
1339006|NCT01955629|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were assessed using the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs were defined as any of following AEs: grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia associated with bleeding requiring transfusion; grade 4 non-hematological treatment related event; grade 3 nausea/vomiting or diarrhea lasting >/= 4 days despite corrective measures; grade 3 other non-hematological toxicities: anorexia, fatigue, hypertension only if G4 or not medically controlled and G3 peripheral sensory neuropathy that did not improve to G<2 at time of retreatment; urinary protein excretion of >3.5 gram per 24 hours that did not recover to <2.0 gram per 24 hours within 2 weeks; symptomatic arterial thromboembolic events including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, new onset or worsening of pre-existing angina.|Cycle 1 (Up to 3 weeks)|Evaluable DLT population defined as the subset of the whole part 1 participants that were exposed to at least 1 dose (even incomplete) of the study treatment and had a DLT assessment at Cycle 1.|||Participants|||Number
1339007|NCT01955564|Secondary|Total Drug Exposure Over Time (AUC0-t) of NW-3509A at Doses Tested|"Plasma concentration data, derived PK parameters, and urine data were summarized as total drug exposure over time (AUC0-t).~The plasma concentrations of NW‑3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18)."|Baseline up to 32 hours post-dose||||ng.h/mL||Standard Deviation|Mean
1339008|NCT01955564|Secondary|Maximum Plasma Concentration of NW-3509A at Doses Tested|"Plasma concentration data, derived PK parameters, and urine data are summarized as maximum plasma concentration (Cmax).~The plasma concentrations of NW‑3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18)."|Baseline up to 32 hours post-dose||||ng/mL||Standard Deviation|Mean
1339009|NCT01955564|Primary|Physical Examination Shift Table|Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.|Day -1(pre-dose) through Day 8 (Discharge)||||Participants abnormal at end of study|||Number
1339010|NCT01955473|Secondary|Percentage of Participants With EGFR Amplification Using Fluorescent in Situ Hybridization (FISH) Method.||Week 1 (pre-dose) and Week 4.|The Biomarker analysis set consisted of all subjects who received at least 1 administration of Sym004 and who had at least 1 biomarker evaluation.|||percentage of subjects|||Number
1339011|NCT01955473|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression in Skin Tissues by Immunohistochemistry (IHC)|IHC is a staining process performed on fresh/frozen cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. A value designated the IHC score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Week 1 (pre-dose), Week 4 and Week 5|The Biomarker analysis set consisted of all subjects who received at least 1 administration of Sym004 and who had at least 1 biomarker evaluation.|||percentage of subjects|||Number
1339013|NCT01955473|Secondary|Progression-free Survival Time|The Progression-free survival time was measured from the date of subject enrollment until the date that disease progression was objectively documented or death. Progression-free survival time estimated with using the Kaplan-Meier method. Progression-free survival time was planned to be reported for Part B alone and Part A/B combined reporting arms.|Time from enrollment until the date of objectively documented disease progression or death, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||months||95% Confidence Interval|Median
1339014|NCT01955473|Secondary|Time to Progression|Time to progression was defined as the time from date of subject enrollment until the date that disease progression was objectively documented. TTP estimated using the Kaplan-Meier estimates. TTP was planned to be reported for Part B alone and Part A/B combined reporting arms.|Time from enrollment until the date of objectively documented disease progression or death, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||months||95% Confidence Interval|Median
1339015|NCT01955473|Secondary|Duration of Disease Control|Duration of disease control measured from the time measurement criteria were first met for CR, PR, or SD (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented. CR: disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 45.1 weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication. Here, “Number of Participants Analyzed” signifies those subjects who achieved disease control.|||Weeks||Full Range|Median
1339016|NCT01955473|Secondary|Percentage of Subjects With Disease Control|Percentage of subjects with disease control (defined as confirmed CR, confirmed PR, or confirmed SD) ) according to RECIST Version 1.1 was reported. CR: disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Confirmed CR or PR: response confirmed at an interval of at least 4 weeks. Confirmed SD: response confirmed at an interval of at least 6 weeks.|Week 7 and thereafter every 6 weeks, up to 4 weeks after last dose for Part A or up to 8 weeks after the last dose for Part B (up to 45.1 Weeks)|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||percentage of subjects||95% Confidence Interval|Number
1339017|NCT01955473|Secondary|Duration of Overall Response|The duration of overall response was measured from the time measurement criteria were first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed CR or PR was defined as the response that was confirmed at an interval of at least 4 weeks.|Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication. Here, “Number of Participants Analyzed” signifies those subjects who achieved confirmed CR or PR.|||Weeks||Full Range|Median
1339018|NCT01955473|Secondary|Percentage of Subjects With Best Overall Response|Percentage of subjects with best overall response (defined as confirmed CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimiter (mm). PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed CR or PR was defined as the response that was confirmed at an interval of at least 4 weeks.|Week 7 and thereafter every 6 weeks, up to 4 weeks after last dose for Part A or up to 8 weeks after the last dose for Part B (up to 45.1 Weeks)|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||percentage of subjects|||Number
1339019|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||hours||Full Range|Median
1339020|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||hours||Full Range|Median
1339021|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||hours||Full Range|Median
1339022|NCT01955473|Secondary|Trough Concentrations (Ctrough) of Sym004|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Ctrough are presented for both monoclonal antibodies.|Pre-infusion at Week 2, 3, 5, 6, 7, 8, End of Trial (up to 41.1 weeks) and Follow up (up to 45.1 Weeks)|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified time frame."|||μg/mL||Standard Deviation|Mean
1339023|NCT01955473|Secondary|Dose Normalized Maximum Serum Concentration (Cmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment. Dose normalized Cmax was calculated as Cmax/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339024|NCT01955473|Secondary|Dose Nornamized Maximum Serum Concentration (Cmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized Cmax are presented for both monoclonal antibodies. Dose normalized Cmax was calculated as Cmax/Dose. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339025|NCT01955473|Secondary|Dose Normalized Maximum Serum Concentration (Cmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Dose Normalized Cmax are presented for both monoclonal antibodies. Dose normalized Cmax was calculated as Cmax/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339026|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1339027|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1339028|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1339029|NCT01955473|Secondary|Volume of Distribution at Steady State (Vss) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Liter||Geometric Coefficient of Variation|Geometric Mean
1339030|NCT01955473|Secondary|Volume of Distribution at Steady State (Vss) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter||Geometric Coefficient of Variation|Geometric Mean
1339031|NCT01955473|Secondary|Volume of Distribution at the Elimination Phase (Vz) of Sym004 at Week 1: Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vz are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter||Geometric Coefficient of Variation|Geometric Mean
1339032|NCT01955473|Secondary|Clearance at Steady-state (CLss) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CLss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
1339033|NCT01955473|Secondary|Clearance at Steady-state (CLss) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CLss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
1339034|NCT01955473|Secondary|Clearance (CL) of Sym004 at Week 1: Single Dose|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CL are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
1339035|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 For the Biweekly Regimen at Week 5: Multiple Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||hours||Geometric Coefficient of Variation|Geometric Mean
1339036|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||hours||Geometric Coefficient of Variation|Geometric Mean
1339037|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 at Week 1: Single Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||hours||Geometric Coefficient of Variation|Geometric Mean
1339038|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339039|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339040|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339041|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12 and 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339042|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 48 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339043|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only. Dose normalized AUC for AUC0-336 was calculated as AUC(0-336)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 168 and 336 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339044|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only. Dose normalized AUC for AUC0-336 was calculated as AUC(0-336)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48, 168, 336 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339045|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, 168 and 336 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339046|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48, 168, 336 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339047|NCT01955473|Secondary|Dose Nornamized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-168 was calculated as AUC(0-168)/Dose. Results were to be assessed for weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 168 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339048|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-168 was calculated as AUC(0-168)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 and 168 hours post-infusion at Week 1|"The Pharmacokinetics (PK) Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1339057|NCT01955434|Other Pre-specified|Activating Mutations of the NFKB Pathway|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Up to 1 year|||||||
1339058|NCT01955434|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 1 year||||months||95% Confidence Interval|Median
1339049|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 168 hours post-infusion at Week 4|The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here “Number of Participants Analyzed” =subjects who were evaluable for this outcome and “n” =subjects who were evaluable for specified monoclonal antibody.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339050|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 and 168 hours post-infusion at Week 1|The Pharmacokinetics (PK) Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339051|NCT01955473|Primary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the Sym004 or if they started prior to administration but worsened after receiving the first dose of treatment.|Baseline up to 4 weeks after the last Sym004 administration, up to a maximum of 41.1 weeks|Safety analysis set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004.|||subjects|||Number
1339052|NCT01955473|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs) Determined in Part-A|DLT: any of the following National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period of Part A, and were considered by Investigator to be at least possibly related to study treatment, and confirmed by Safety Monitoring Committee. Hematological toxicities: Grade 4 neutropenia, febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding episodes. Nonhematological toxicities: Grade 3 or higher non-hematological toxicity with exception of Grade 3 fatigue/skin toxicity; Grade 3 nausea/vomiting without appropriate prophylactic therapy; Grade 3 diarrhoea recovered within 2 days with adequate treatment or did not accompany fever/dehydration; Grade 3 or 4 laboratory liver parameter abnormalities with duration of less than 3 days.|Week 1 up to Week 4 (Part A)|DLT Analysis Set consisted of all subjects who received at least 3 of 4 weekly administrations (for weekly dosing cohort) or who received 2 biweekly administrations (for biweekly dosing cohort) and experienced a DLT during DLT observation period.|||subjects|||Number
1339053|NCT01955434|Other Pre-specified|Degradation of cIAP1 in PBMC|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Baseline up to 1 year|||||||
1339054|NCT01955434|Other Pre-specified|Changes in Serum Cytokines|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Baseline up to 1 year|||||||
1339055|NCT01955434|Other Pre-specified|Changes in Immune Cell Subsets|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Baseline up to 1 year|||||||
1339056|NCT01955434|Other Pre-specified|Change in Patient-reported Outcomes (Quality of Life and Symptoms)|Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Changes from baseline at each cycle will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel’s adjustment) using Cohen’s cut-offs. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.|Baseline up to 1 year|||||||
1339091|NCT01955083|Secondary|Percent Change in B1-SI After MIS|Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-SI||Standard Error|Mean
1339059|NCT01955434|Secondary|Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)|The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event are reported below.|Up to 30 days after the last day of study drug treatment||||percentage of patients|||Number
1339060|NCT01955434|Secondary|Event-free Survival|The event-free survival time is defined as the time from registration to disease progression while receiving LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma. Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of cyclophosphamide. If a patient goes off study treatment and never received cyclophosphamide, they will be censored on the date they went off study treatment. If a patient initiates cyclophosphamide but later discontinues cyclophosphamide due to toxicity and continues LCL161 alone, disease progression on LCL161 alone will be considered an event in this case. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.|From registration to disease progression while receiving SMAC mimetic LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 1 year|Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.|||months||95% Confidence Interval|Median
1339061|NCT01955434|Secondary|Combination Agent Response Rate|The overall response rate (percentage) with the addition of cyclophosphamide will be estimated by the number of patients who achieve a confirmed overall response at any time (with SMAC mimetic LCL161 plus cyclophosphamide) divided by the number of evaluable patients times 100. 95% confidence intervals for the true confirmed overall response rate will be calculated by the exact binomial method.|Up to 1 year|Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
1339062|NCT01955434|Primary|Confirmed Overall Response Rate (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) With Single Agent SMAC Mimetic LCL161|The primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), or PR (If present at baseline, ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to <200 mg/24hrs) noted as the objective status on two consecutive evaluations while receiving single agent LCL161.The rate (percentage) of successes will be estimated by the number of successes divided by the total number of evaluable patients times 100. 95% confidence intervals for the true success percentage will be calculated by the exact binomial method.|Up to 1 year||||percentage of patients||95% Confidence Interval|Number
1339063|NCT01955382|Primary|Safety|To assess the safety of adjunct treatment with oAC; specifically, children were hospitalized while their vital signs were measured, IV site inspected, state of consciousness assessed, and selected symptoms (nausea, vomiting, diarrhea, constipation, abdominal pain, headache, and dizziness) surveyed at 0, 2, 4, 6, 8, and 12 hours, and then every 6 hours until 48 hours or until parasitemia became undetectable (one negative thick blood film), whichever was later.|During patient treatment up to 48 hours|Children who received treatment per protocol|||Participants|||Count of Participants
1339064|NCT01955382|Primary|Parasite Clearance Half-life|To compare parasite clearance half-life in patients treated with IV AS + oAC or IV AS alone; parasite clearance half-life is the time it takes for the parasite density to decrease by half, and can be assessed by analysing frequent parasite density counts at 0, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after initiating treatment.|During patient treatment||||Hours||Standard Deviation|Mean
1339065|NCT01955369|Other Pre-specified|Gastrostomy|gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration|an average of 3 years||||participants|||Number
1339066|NCT01955369|Secondary|Tracheostomy|tracheostomy in ALS patients following respiratory failure|an average of 3 years||||participants|||Number
1339067|NCT01955369|Primary|Death|death of participating ALS patients independent of the cause of death|an average of 3 years||||participants|||Number
1339068|NCT01955161|Secondary|Change in Health-related Quality of Life (EQ-5D VAS)|"Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1339069|NCT01955161|Secondary|Change in Health-related Quality of Life (EQ-5D) Utility Score|"Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1339116|NCT01954628|Secondary|The Number of Subjects With at Least One COPD Exacerbation.|The number of subjects that presented with a COPD exacerbation during the 12 week treatment period.|12 weeks|Full analysis set.|||participants|||Number
1339070|NCT01955161|Secondary|Change in Cognitive Aspects of Mental Function|Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1339071|NCT01955161|Secondary|Clinical Worsening|Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
1339072|NCT01955161|Secondary|Clinical Improvement|Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
1339073|NCT01955161|Secondary|Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline|"Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed|||units on a scale||Standard Error|Least Squares Mean
1339074|NCT01955161|Secondary|Change in Individual Behavioural Disturbance Items|"Change in single NPI item scores at Week 24.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed|||units on a scale||Standard Error|Least Squares Mean
1339075|NCT01955161|Secondary|Change in Behavioural Disturbance|"Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1339076|NCT01955161|Secondary|Change in Global Impression|"Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.~The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1339092|NCT01955083|Secondary|Percent Change in Total-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Fmean||Standard Error|Mean
1339093|NCT01955083|Secondary|Percent Change in Total-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Fpeak||Standard Error|Mean
1339077|NCT01955161|Secondary|Change in Daily Functioning|"Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.~The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1339078|NCT01955161|Primary|Change in Cognition|"Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.~The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
1339079|NCT01955122|Secondary|Patient Satisfaction|"Follow up phone call was done 24 hours post procedure. Patients were asked the following : On a 0 to 10 scale, with “0” being no pain and “10” being pain as bad as you can imagine, how would you describe your colonoscopy experience? 0 1 2 3 4 5 6 7 8 9 10"|24 hours post procedure|Data was not analyzed since the patients satisfactory score was general estimation which could not be associated with either the standard colonoscopy or the EndoRings colonoscopy, therefore the intended endpoint failed.||||||
1339080|NCT01955122|Secondary|Colon Area Screened|Subjective evaluation of the additional area screened by the physician.|During the procedure|Evaluation of the additional area screened by the physician was not collected from any participant during the study||||||
1339081|NCT01955122|Secondary|Scope Centering Ability|Ability to center the scope inside the gastrointestinal tract.|During the procedure|Centering ability was not collected from any procedure during the study||||||
1339082|NCT01955122|Secondary|Sedation|Sedation dosage|During the procedure|Sedation dosage was not collected from any participant during the study||||||
1339083|NCT01955122|Secondary|Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured|The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured|During the procedure||||minutes||Standard Deviation|Mean
1339084|NCT01955122|Secondary|Total Number of Therapeutic Interventions Performed|Ability to perform therapeutic interventions, such as biopsies, polypectomies, APC etc. during the Standard Colonoscopy and during the EndoRings Colonoscopy. The number of interventions was not compared, this was just a safety outcome meant to prove there was no difficulty in performing interventions in both arms.|Interventions during procedure||||Total Interventions performed|||Number
1339085|NCT01955122|Primary|Adenoma and Polyp Miss Rate|"Group A- we measured the Adenoma&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings).~Group B- we measured the Adenoma&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard).~Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group]*100"|30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.||||percentage of :Adenomas/Polyp missed||95% Confidence Interval|Number
1339086|NCT01955083|Post-Hoc|Percentage of Good Response After MIS|Postoperative ‘VAS <=3’ was traditionally defined as ‘major response’. For a comprehensive profile of the outcomes, we further created another definition of ‘fine response’: ‘postoperative VAS <=5 plus SOS >=60’ post hoc in the present study. Accordingly, patients with a postoperative VAS <=3 or postoperative VAS <=5 plus SOS >=60' group was considered to have a 'good response'. Therefore, we calculated the 'good response' rate in the radiofrequency and pillar implant groups.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Good Response||Standard Error|Mean
1339087|NCT01955083|Secondary|Percent Change in B1-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Fmean||Standard Error|Mean
1339088|NCT01955083|Secondary|Percent Change in B1-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Fpeak||Standard Error|Mean
1339089|NCT01955083|Secondary|Percent Change in B1-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Imean||Standard Error|Mean
1339090|NCT01955083|Secondary|Percent Change in B1-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Imax||Standard Error|Mean
1339163|NCT01954160|Secondary|Resting Plasma Norepinephrine||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339098|NCT01955083|Primary|Change in VAS Score After MIS|The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement.|baseline and 3 months following surgery|Twenty-eight patients completed the protocol; two study cases were not available for follow-up. Fourteen patients underwent radiofrequency surgery and 14 patients received pillar implant surgery. Accordingly, we analyzed the participants who completed the study protocol.|||units on a scale||95% Confidence Interval|Mean
1339099|NCT01955044|Secondary|Resolvin Levels|resolvin, a metabolite of LCPUFA, will be measured at 2 weeks of life.|2 weeks of life||2018-02-28|02/2018||||
1339100|NCT01955044|Secondary|Resolvin Levels|Resolvin, a metabolite of LCPUFA, will be measured at 8 weeks of life.|8 weeks of life||2018-02-28|02/2018||||
1339101|NCT01955044|Secondary|LCPUFA Levels|LCPUFA levels will be measured at 8 weeks of life.|8 weeks of life||||wt% (g/100g)||Inter-Quartile Range|Median
1339102|NCT01955044|Primary|Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels|LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants|2 weeks of life|2 subjects died prior to having 2 week levels drawn, from causes unrelated to study.|||weight % (g/100g)||Inter-Quartile Range|Median
1339103|NCT01955005|Secondary|Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.|Therapeutic duplication will be defined as concurrent use of more than one medication from the same therapeutic class. For laboratory duplication, we will review non-VA and VA medical records 6 months prior to the non-VA provider visit. Each patient will be assigned a dichotomous indicator for whether they received therapeutic duplication and/or laboratory duplication during their non-VA provider visit|Typically within 1 month of non-VA provider visit|Some veterans had their laboratories drawn prior to the medical visit and were therefore excluded from this analysis.|||proportion of participants|||Number
1339104|NCT01955005|Secondary|Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists|A medication discrepancy metric was be calculated by comparing the current VA medication list with the non-VA provider medication list to determine the total number of distinct medications. The number of discrepant medications between these lists is the numerator and is divided by the total number of distinct medications on both lists combined. This will yield a range of scores between score between 0 and 1, with 1 indicating perfect agreement between the two lists.|Typically within 1 month of non-VA provider visit|Medication reconciliation was based on Medical Record Review, therefore there was better representation of the entire sample. 2 Veterans were not included in the Internet Skills Training group because the medical records sent from the Non-VA provider were not adequate to determine an accurate medication list.|||proportion of medications discrepant||Standard Deviation|Mean
1339105|NCT01955005|Primary|Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider|The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.|Within 1-2 week of non-VA provider visit|This outcome was collected from the provider completed questionnaire. The reduced sample size is due to the response rate for the My Healthe Vet training group providers (74%) and the Internet Skills Training group (52%).|||Percentage of Participants|||Number
1339106|NCT01954771|Secondary|HbA1c(%) at Endpoint||12 weeks|13 patients did not followed the study protocol.|||percentage||Inter-Quartile Range|Median
1339107|NCT01954771|Secondary|Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS|Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).|12 weeks|13 patients did not followed the study protocol.|||participants|||Number
1339108|NCT01954771|Secondary|The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS|A correlation coefficient of 0.5 is defined as large effect size.(Cohen Jacob.Statistical power analysis for the the behavioral sciences.2nd edition.Lawrence Erlbaum Associates.1988:80)|12 weeks|13 patients did not followed the study protocol.|||mmol/L||Inter-Quartile Range|Median
1339109|NCT01954771|Primary|Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)|The peak value:＞16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).|12 weeks|13 patients did not followed the study protocol.|||mmol/L||Inter-Quartile Range|Median
1339110|NCT01954745|Secondary|Median Overall Survival (OS)|To evaluate the median overall survival (OS) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||months||95% Confidence Interval|Median
1339111|NCT01954745|Secondary|Objective Response Rate (ORR)|To evaluate the objective response rate (ORR) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||percent|||Number
1339112|NCT01954745|Secondary|Number of Patients With Adverse Events|Evaluate the number of patients with advanced cholangiocarcinoma being treated with cabozantinib who have adverse events during treatment|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||participants|||Number
1339113|NCT01954745|Primary|Median Progression Free Survival (PFS)|To evaluate the median progression free survival (PFS) of cabozantinib in patients with advanced cholangiocarcinoma after progression on 1 or 2 prior systemic therapies.|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||months||95% Confidence Interval|Median
1339114|NCT01954628|Secondary|AQX-1125 Concentrations in Plasma (Trough Values)|The secondary objectives are to evaluate the pharmacokinetics (PK) of AQX-1125 in plasma.|12 weeks|PK Population|||micrograms per Liter||Geometric Coefficient of Variation|Geometric Mean
1339115|NCT01954628|Secondary|Change From Baseline in FEV1|"The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on forced expiratory volume in 1 second [FEV1].~FEV1 was determined from post-bronchodilator spirometry testing done at clinic visits."|12 weeks|Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle.|||Liter||95% Confidence Interval|Least Squares Mean
1339117|NCT01954628|Secondary|Time to First COPD Exacerbation|The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the time to first exacerbation requiring medical intervention of oral corticosteroids and/or antibiotics.|12 weeks|Full analysis set|||day(s)||Standard Deviation|Mean
1339118|NCT01954628|Secondary|Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE))|"The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the number of COPD exacerbations (MTE).~COPD exacerbations were referred to as Medically Treated Exacerbations (MTEs) and identified as a change in symptoms and/or signs of COPD requiring prescription of one or both of: (1) Course of oral corticosteroids or (2) Antibiotic(s)."|12 weeks|Full analysis set was used and analyzed using the negative binomial regression model with fixed factors treatment, region and time in study as offset. Adjusted means for treatment group shows number of exacerbations/year.|||Number of exacerbations/year||95% Confidence Interval|Least Squares Mean
1339119|NCT01954628|Secondary|Change From Baseline in COPD Assessment Tool (CAT) Score|The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the COPD Assessment Tool (CAT) score.The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from baseline indicates improvement. The change in total CAT score from Day 1, before taking study drug (baseline), to end of the 12 week treatment period was compared between the two treatments using an ANOVA model adjusting for treatment and region and including the baseline score as a covariate.|12 weeks|Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle.|||COPD Assessment Tool Score||95% Confidence Interval|Least Squares Mean
1339120|NCT01954628|Primary|The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.|The primary variable (endpoint) of this study is the difference in the Area Above the Curve (AAC) for the daily EXACT score from baseline to Week 12 between subjects treated with AQX-1125 and placebo.The EXACT questionnaire is a patient reported outcome (PRO) measure designed to standardise the method for evaluating the frequency, severity and duration of acute exacerbations of COPD. The EXACT is a 14-item daily questionnaire where each item is assessed on a 5 or 6 point ordinal scale. Participants completed the EXACT questionnaire on a daily basis via an electronic diary from Day 1 (pre-dose) to Day 84 (week 12). Higher scores on the daily EXACT questionnaire indicate a more severe health state. When the post-treatment EXACT scores are lower (i.e. improved symptoms) than baseline EXACT, the AACs are positive.|12 weeks|Full Analysis Set (FAS). The FAS was all randomized subjects who have received at least one dose of the study drug and had at least one efficacy assessment (valid diary entries) post-baseline. Imputation, the mean of the last 5 days, counted backwards from day of last recording, in the treatment period will be used.|||Area Above Curve on Daily Exact Score||95% Confidence Interval|Least Squares Mean
1339121|NCT01954394|Secondary|Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||ratio||Standard Deviation|Mean
1339122|NCT01954394|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339123|NCT01954394|Secondary|Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339124|NCT01954394|Secondary|Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339125|NCT01954394|Secondary|Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339126|NCT01954394|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339164|NCT01954160|Secondary|Plasma N-terminal Pro-brain Natriuretic Peptide||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339127|NCT01954394|Secondary|Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339128|NCT01954394|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339129|NCT01954394|Secondary|Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percentage of participants|||Number
1339130|NCT01954394|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percentage of participants|||Number
1339131|NCT01954394|Secondary|Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percentage of participants|||Number
1339132|NCT01954394|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||mmol/L||Standard Deviation|Mean
1339133|NCT01954394|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||mg/dL||Standard Deviation|Mean
1339134|NCT01954394|Secondary|Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|Modified ITT (mITT) population: all enrolled and treated participants with 1 baseline (from parent study) and at least 1 post-baseline calculated LDL-C value on-treatment. “Number analyzed” = participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
1339135|NCT01954394|Primary|Percentage of Participants Who Experienced Adverse Events (AEs)|Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.|Up to 10 weeks after last study drug administration (maximum of 176 weeks)|All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.|||percentage of participants|||Number
1339136|NCT01954251|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1339137|NCT01954251|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1339165|NCT01954160|Secondary|Left Atrial Size|Echo: Left Atrial size|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339166|NCT01954160|Secondary|LV End Diastolic Dimension (LVEDd)|Echo: LV end diastolic dimension (LVEDd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339138|NCT01954251|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1339139|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
1339140|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
1339141|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
1339142|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
1339143|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 (G3) pain = pain that prevented normal activity. Grade 3 (G3) redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
1339144|NCT01954251|Secondary|Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer|The geometric mean ratio for Flu HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Ratio||95% Confidence Interval|Geometric Mean
1339145|NCT01954251|Secondary|Number of Seroconverted Subjects in Terms of HI Antibodies|The number of seroconverted subjects was assessed in terms of HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1339146|NCT01954251|Secondary|FLU Haemagglutination Inhibition (HI) Antibody Titers|HI antibody titres against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yamma) were expressed as geometric mean titers (GMTs).|At Day 0 (PRE) and Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1339147|NCT01954251|Secondary|Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40|Seroprotection rate is defined as the percentage of vaccines with a serum HI titer ≥1:40 that usually was accepted as indicating protection. FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts(Massach)/2/2012 Yamagata (Yama).|At Day 0 (PRE) and at Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1339148|NCT01954251|Secondary|Number of Subjects With FLU HI Antibody Titers ≥1:10|FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yama). Cut-off titer for seropositivity was 1:10.|At Day 0 (PRE) and 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1339149|NCT01954251|Primary|FLU Haemagglutination Inhibition (HI) Antibody Titers|"For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain.~Adjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs."|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1339150|NCT01954251|Primary|Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies|Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.|At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1339151|NCT01954251|Primary|Vaccine Response for Anti-gE Humoral Immunogenicity|"The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least:~a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%."|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Percentage||95% Confidence Interval|Number
1339152|NCT01954251|Primary|Number of Subjects With Vaccine Response to Anti-gE Antibodies|The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1339153|NCT01954160|Secondary|Left Ventricular End Diastolic Volume|Echo: Left Ventricular End Diastolic Volume|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339154|NCT01954160|Secondary|Tissue Doppler Indices|Echo: Tissue Doppler indices|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339155|NCT01954160|Secondary|Heart Rate Variability|Heart rate variability indices by Holter|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339156|NCT01954160|Secondary|New York Heart Association (NYHA) Functional Classification||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339157|NCT01954160|Secondary|Patient Global Assessment||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339158|NCT01954160|Secondary|Kansas City Cardiomyopathy Questionnaire Score||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339159|NCT01954160|Secondary|6 Minute Walk Test||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339160|NCT01954160|Secondary|Plasma Aldosterone||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339161|NCT01954160|Secondary|Plasma Renin Activity||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339162|NCT01954160|Secondary|Resting Urine Norepinephrine||13 Weeks following Renal Denervation|||||||
1339171|NCT01954160|Secondary|Renal Resistive Index|Intra-renal hemodynamics as measured by Renal Resistive Index (RRI) by renal Doppler ultrasonography Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339172|NCT01954160|Secondary|Urine Albumin|Urine albumin|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339173|NCT01954160|Secondary|Creatinine Clearance From 24-hour Urine Creatinine|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339174|NCT01954160|Secondary|Blood Urea Nitrogen (BUN) Level|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339175|NCT01954160|Secondary|Serum Cystatin C|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339176|NCT01954160|Secondary|Glomerular Filtration Rate|Estimated Glomerular Filtration Rate (GFR) by creatinine and cystatin C|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339177|NCT01954160|Secondary|24-hour Urine Sodium Excretion|Difference in 24-hour urine sodium excretion, compared between pre-RSD and 13 weeks after RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339178|NCT01954160|Secondary|Urine Volume|Urine volume following furosemide therapy after sodium loading.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
1339179|NCT01954160|Primary|Urine Sodium Excretion|Within-subject comparison of increase in urine sodium excretion following saline loading before RSD and 13 weeks following RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected, endpoints not measured||||||
1339180|NCT01954121|Secondary|Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From Randomization (Week 1) up to Evaluation Visit (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||events|||Number
1339181|NCT01954121|Secondary|Time to First Seizure During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||events|||Number
1339182|NCT01954121|Secondary|Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||events|||Number
1339183|NCT01954121|Secondary|Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period||From Week 1 to Week 30|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||percentage of subjects|||Number
1339184|NCT01954121|Primary|Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period||6-months Evaluation Period (From Week 4 to Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||percentage of subjects|||Number
1339185|NCT01953874|Secondary|ESS|The Epworth Sleepiness Scale is a simple, 8-item self-administered questionnaire which provides a measurement of the subject's general level of daytime sleepiness. The individual is asked on a scale of 0–3 to score the likelihood of falling asleep in eight various situations. With a total range of 0 to 24, a higher score indicates increased severity.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1339186|NCT01953874|Secondary|PSQI|"The Pittsburgh Sleep Quality Index is a 19-item subjective measurement of sleep. It is an effective instrument used to measure the quality and patterns of sleep in the older adult. It differentiates “poor” from “good” sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction over the last month. The subject self-rates each of these seven areas of sleep. The seven component scores are then added to yield a total score with a range of 0-21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas."|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1339238|NCT01953224|Other Pre-specified|Number of Participants With Adverse Events|We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.|12 weeks|||||||
1339187|NCT01953874|Secondary|PHQ-9|The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the following scoring severity index: 0 - Not at all, 1 - Several Days, 2 - More than Half the Days, 3 - Nearly Every Day. Total score can range from 0 to 27. A higher score indicates increased severity.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis|||scores on a scale||Standard Deviation|Mean
1339188|NCT01953874|Secondary|EQ-5D-5L Index|The EQ-5D-5L is a standardized self-report questionnaire that is used as a measure of health outcome. The EQ-5D-5L questionnaire is comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses were indexed using the EQ-5D-5L US value set to scale the 5 dimensions. A score of -0.109 indicates extreme problems for all dimensions and a score of 1.000 indicates no problems for all dimensions. Therefore, a higher score indicates better general health.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1339189|NCT01953874|Secondary|DASI|The Duke Activity Status Index is a 12-item patient-reported outcome validated for the assessment of functional capacity based on the ability to perform everyday activities. With a total range of 0 to 58.20, a higher score indicates better quality of life.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1339190|NCT01953874|Secondary|Time Dead/Hospitalized|Total days dead or hospitalized at study end|6 months||||number of days||Standard Deviation|Mean
1339191|NCT01953874|Secondary|Death|Rate of Cardiovascular and all-cause death|2 days, 1 week, 1, 2, 3, and 6 months||||Participants|||Count of Participants
1339192|NCT01953874|Secondary|Number of Subjects With HF Hospitalization|Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason|2 days, 1 week, 1, 2, 3, and 6 months||||Participants|||Count of Participants
1339193|NCT01953874|Secondary|Sleep Parameters|Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia)|Change from Baseline to 6 months|Not all subjects in the active arm successfully measured ODI. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||events per hour||Standard Deviation|Mean
1339194|NCT01953874|Secondary|Win Ratio|Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labeled a ‘winner’ or a ‘loser’ depending on who had a CV death first. If that is not known, they are labeled a ‘winner’ or ‘loser’ depending on who had a HF hospitalization first. Otherwise they are considered tied. The win ratio is the total number of winners divided by the total numbers of losers.|6 months||||Ratio||95% Confidence Interval|Number
1339195|NCT01953874|Secondary|ECHO Parameters - E/e' Ratio|Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e’ (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFpEF (heart failure with preserved ejection fraction).|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis. HFrEF and HFpEF subjects were separated accordingly.|||ratio||Standard Deviation|Mean
1339196|NCT01953874|Secondary|ECHO Parameters - LVESVI|Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e’ (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||mL/m^2||Standard Deviation|Mean
1339197|NCT01953874|Secondary|ECHO Parameters - LVEF|Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e’ (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||%EF||Standard Deviation|Mean
1339198|NCT01953874|Secondary|Biomarkers - Renal Function|Biomarkers of renal function reported as creatinine|Change from Baseline to 6 months|Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||mg/dL||Standard Deviation|Mean
1339199|NCT01953874|Secondary|Biomarkers - Cardiovascular|Biomarkers of cardiovascular function reported as hs-CRP|Change from Baseline to 6 months|Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||mg/L||Standard Deviation|Mean
1339200|NCT01953874|Secondary|Biomarkers - Inflammation|Biomarkers of inflammation reported as troponin I ultra-sensitive|Change from Baseline to 6 months|Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||ng/mL||Standard Deviation|Mean
1339239|NCT01953224|Other Pre-specified|Number of Counseling Calls Completed From Baseline to 12 Weeks|Based on counselor logs, we will determine the number of counseling phone calls completed for each participant|12 weeks|||||||
1339201|NCT01953874|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1339202|NCT01953874|Secondary|NT Pro-BNP|Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||pg/mL||Standard Deviation|Mean
1339203|NCT01953874|Secondary|Six-minute Walk Distance|Change in functional parameters as measured by 6-minute walk test (6MWT)|Change from Baseline to 6 months|"Reasons 6MWT was not performed:~In the MV ASV+OMT arm, 5 were discontinued prematurely, 3 participants could not walk, 4 participants were too critically ill, and 2 participants refused.~In the OMT only arm, 12 were discontinued prematurely, 1 participant could not walk, and 2 participants refused."|||meters||Standard Deviation|Mean
1339204|NCT01953874|Primary|Global Rank Endpoint|A rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD. All participants were first ranked by time to death, then ranked by time to CV hospitalization, and then ranked by percentage change in 6MWD. For time to event measures (time to death and time to hospitalization), the shorter the amount of time, the lower the rank assigned to that participant. For percentage changes in 6MWD, the smaller the percentage change, the lower the rank assigned to that participant. Each component was then combined to create a rank value that ranged between 0 and 100. Overall, higher rank values are associated with better outcomes.|Baseline, 6 months||||Standardized global rank order value||Standard Deviation|Mean
1339205|NCT01953354|Secondary|Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added|New or increase in UC medications is defined as a need for dose-escalation of concurrent medications or need for rescue medications to treat UC through Week 16.|From Day 0 through Week 16|The Safety population included all subjects for whom study treatment was initiated.|||percentage of participants|||Number
1339206|NCT01953354|Secondary|Percent of Participants With Increase in Diarrhea|An increase in diarrhea is defined as an increase in the Mayo Score’s Stool Frequency score by at least 1 point from baseline at any time during follow-up.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.|||percentage of participants|||Number
1339207|NCT01953354|Secondary|Percent of Participants With Colonoscopic Evidence of Visible Worm|Stool evaluations for ova and parasites confirmed the absence of T. suis. If evidence suggested a presence of T. suis, a colonoscopy would be performed to confirm invasion with a visible worm.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.|||percentage of participants|||Number
1339208|NCT01953354|Secondary|Time to Modified Clinical Response|Number of days to reach a modified clinical response. Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed.|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects who achieved a modified clinical response are included in this analysis.|||Days||Full Range|Median
1339209|NCT01953354|Secondary|Percent of Participants With a Modified Clinical Response|Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with baseline and at least one post-baseline modified clinical response result are included in this analysis.|||percentage of participants|||Number
1339210|NCT01953354|Secondary|Percent of Participants With Healed Colonic Mucosa at Week 12|Healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with a Mayo endoscopy score at Week 12 are included in this analysis.|||percentage of participants|||Number
1339211|NCT01953354|Secondary|Percent of Participants Who Achieved Remission at Week 12|Remission is defined as a Mayo score of less than or equal to 1 with absence of rectal bleeding and endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with remission results at Week 12 are included in this analysis.|||percentage of participants|||Number
1339212|NCT01953354|Primary|Percentage of Participants Who Achieved a Clinical Response at Week 12|Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with clinical response results at Week 12 are included in this analysis.|||percentage of participants|||Number
1339213|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1339214|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1339215|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1339216|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1339217|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1339242|NCT01953224|Other Pre-specified|Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks|We will investigate the number of participants who drop out of the intervention group in comparison to the control group and to norms for similar studies|12 weeks|||||||
1339243|NCT01953224|Secondary|Change in Motivation From Baseline to 12 Weeks|We will measure intrinsic motivation using the intrinsic regulation subscale from the Behavioral Regulation in Exercise Questionnaire-2. This measure uses a scale from 0 (not true for me) to 4 (very true for me). Positive changes indicate increases in intrinsic motivation over time. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|One participant did not provide usable data at baseline.|||units on a scale||Standard Deviation|Mean
1339244|NCT01953224|Secondary|Change in Weight From Baseline to 12 Weeks|We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks||||pounds||Standard Deviation|Mean
1339245|NCT01953224|Secondary|Change in Blood Pressure From Baseline to 12 Weeks|Systolic and diastolic blood pressure will be measured using standard methods. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here.|||mmHg||Standard Deviation|Mean
1339246|NCT01953224|Secondary|Change in Body Fat Percentage From Baseline to 12 Weeks|We will use dual x-ray absorptiometry to measure body fat percentage. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks||||percent body fat||Standard Deviation|Mean
1339247|NCT01953224|Secondary|Change in Physical Fitness From Baseline to 12 Weeks|Maximal treadmill test to measure fitness (operationalized as the amount of oxygen used by the body during maximal effort). Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here.|||mL/kg/min||Standard Deviation|Mean
1339248|NCT01953224|Primary|Change in Physical Activity From Baseline to 12 Weeks|Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|Four participants' baseline data were found to be invalid based on standard protocols for accelerometer data cleaning/preparation (i.e., 4 days of 10+ hours wear time)|||minutes per day||Standard Deviation|Mean
1339249|NCT01953081|Secondary|Gastric Emptying by Breath Test|Time to 1/2 gastric emptying by breath test|180 minutes|One subject in the TD-8954 group did not receive the full dose of TD-8954 and was excluded from the TD-8954 analysis.|||minutes||Standard Deviation|Mean
1339250|NCT01953081|Secondary|Cmax|Maximum plasma concentration|72 hours|One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group.|||pg/mL||Standard Deviation|Mean
1339251|NCT01953081|Secondary|AUC|Area under the plasma concentration time curve from 0 to 72 hours after dosing.|72 hours|One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group.|||pg*hr/mL||Standard Deviation|Mean
1339252|NCT01953081|Secondary|Gastric Retention by Scintigraphy|Number of subjects with retention less than 13% at 180 minutes after dosing.|180 minutes|ITT|||participants|||Number
1339253|NCT01953081|Secondary|Tmax|Time to maximal concentration in plasma|72 hours|PK Analysis set for subjects receiving TD-8954, metoclopramide concentrations were not measured in the metoclopramide group.|||hours||Full Range|Median
1339254|NCT01953081|Primary|Adverse Events|the number of subjects reporting adverse events by treatment group|6 Days|Safety Population|||participants|||Number
1339255|NCT01952834|Secondary|Interleukin-12|This is a circulating plasma cytokine|Change before and after 6 weeks of probiotic|Subjects with plasma samples available pre and post probiotic supplementation|||pg/mL||Standard Error|Mean
1339256|NCT01952834|Secondary|Interleukin 8|Circulating cytokine measured in the plasma|Change before and after 6 weeks of daily Probiotic||||pg/mL||Standard Error|Mean
1339257|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|Flow Mediated Dilation is measured as the percent change in brachial artery diameter as measured by high resolution ultrasound based on arterial diameter prior to and following 5 minute flow occlusion to the forearm . We measured the percent change in brachial diameter before vancomycin was started and again 10 days after vancomycin|Change before and after 10 days of Vancomycin, approximately 12 weeks from baseline|Subgroup analyzed who volunteered to have vancomycin|||percent change||Standard Deviation|Mean
1339258|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans that reports the percent change in brachial artery diameter to a flow stimulus in the arm induced by 5 minutes of occlusion of flow to the arm. It is measured as the percent change from baseline diameter.|% Change before and after 6 weeks of daily Probiotic||||percent change||Standard Deviation|Mean
1339259|NCT01952691|Secondary|Adduction Angle|we aimed to see the change in hallux valgus angle during treatment.|baseline and 30th days.||||degrees|Participants|Standard Deviation|Mean
1339260|NCT01952691|Secondary|FFI|We aimed to see the change in functional status with FFI (Foot function index) scale The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales used to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) that best describes the patients' foot over the past week. Patients were instructed to mark a VAS score for each question. The total score was calculated using only the questions answered.|baseline, on the 3rd, 7th, 10th and 30th days during the treatment||||units on a scale|Participants|Standard Deviation|Mean
1339261|NCT01952691|Primary|Adduction Angle of Hallux With X RAY|X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping|up to 30 days after the treatment|35 feet's X Ray results were obtained from 22 patients before treatment protocol was performed.|||degrees|Participants|Standard Deviation|Mean
1339274|NCT01952665|Secondary|Likelihood to Continue Wearing the Study Lens|Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely|4 weeks||||participants|||Number
1339262|NCT01952678|Secondary|Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population|Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.|Day 1|PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.|||Overall percent agreement||95% Confidence Interval|Number
1339263|NCT01952678|Secondary|Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population|Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.|Day 1|The intent-to-diagnose (ITD) population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.|||Overall percent agreement||95% Confidence Interval|Number
1339264|NCT01952678|Primary|Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population|The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.|||Negative percent agreement||95% Confidence Interval|Number
1339265|NCT01952678|Primary|Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population|The majority blinded visual interpretation of each participant’s image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.|||Negative percent agreement||95% Confidence Interval|Number
1339266|NCT01952678|Primary|Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population|The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.|||Positive percent agreement||95% Confidence Interval|Number
1339267|NCT01952678|Primary|Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population|The majority blinded visual interpretation of each participant’s image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.|||Positive percent agreement||95% Confidence Interval|Number
1339268|NCT01952665|Primary|Lens Preference for Handling|Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks||||participants|||Number
1339269|NCT01952665|Primary|Lens Preference Comfort, Dryness, Vision and Overall.|Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks||||participants|||Number
1339270|NCT01952665|Primary|Lens Preference|Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks||||participants|||Number
1339271|NCT01952665|Secondary|Participant Likelihood of Recommendation of a Study Lens|Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).|4 weeks||||participants|||Number
1339272|NCT01952665|Secondary|Participant Recommendation of a Study Lens|Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks||||participants|||Number
1339273|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
1339343|NCT01952366|Primary|Depression|Relapse/recurrence of depression|1 year after inclusion to the study|Inpatients|||participants|||Number
1339275|NCT01952665|Secondary|Likelihood of Switching From Habitual Lens to Study Lens|Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely|4 weeks||||participants|||Number
1339276|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|4 Weeks||||lenses|lenses||Number
1339277|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|4 Weeks||||units on a scale|lenses|Standard Deviation|Mean
1339278|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|4 Weeks||||units on a scale|lenses||Number
1339279|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)|4 Weeks||||lenses|lenses||Number
1339280|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)|4 Weeks||||lenses|lenses||Number
1339281|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|4 Weeks||||units on a scale||Standard Deviation|Mean
1339282|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|4 Weeks||||units on a scale||Standard Deviation|Mean
1339283|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|4 Weeks||||logMAR||Standard Deviation|Mean
1339284|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
1339285|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
1339286|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
1339287|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
1339288|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks||||participants|||Number
1339289|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks||||participants|||Number
1339290|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)|4 weeks||||units on a scale||Standard Deviation|Mean
1339291|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|4 weeks||||units on a scale||Standard Deviation|Mean
1339292|NCT01952665|Primary|Handling|Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).|4 weeks||||units on a scale||Standard Deviation|Mean
1339293|NCT01952665|Primary|Dryness|Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).|4 weeks||||units on a scale||Standard Deviation|Mean
1339294|NCT01952665|Primary|Comfort|Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|4 weeks||||units on a scale||Standard Deviation|Mean
1339295|NCT01952665|Primary|Rewetting Drops|Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|4 weeks||||participants|||Number
1339296|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 4 weeks.|4 weeks||||hours||Standard Deviation|Mean
1339297|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)|4 weeks||||hours||Standard Deviation|Mean
1339298|NCT01952665|Primary|Lens Preference, Pair 1 Lotrafilcon B|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )|2 weeks||||participants|||Number
1339299|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|2 Weeks||||lenses|lenses||Number
1339300|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|2 Weeks||||units on a scale|lenses|Standard Deviation|Mean
1339301|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|2 Weeks||||lenses|lenses||Number
1339302|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|2 Weeks||||lenses|lenses||Number
1339303|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal|2 Weeks||||lenses|lenses||Number
1339304|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|2 Weeks||||units on a scale|eyes|Standard Deviation|Mean
1339305|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|2 Weeks||||units on a scale||Standard Deviation|Mean
1339306|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|2 Weeks||||logMAR||Standard Deviation|Mean
1339307|NCT01952665|Primary|Lens Preference, Pair 1 Comfilcon A|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)|2 weeks||||participants|||Number
1339308|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
1339309|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
1339310|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
1339311|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
1339312|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
1339313|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks||||participants|||Number
1339314|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks||||participants|||Number
1339315|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)|2 weeks||||units on a scale||Standard Deviation|Mean
1339316|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|2 weeks||||units on a scale||Standard Deviation|Mean
1339317|NCT01952665|Primary|Handling|Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).|2 weeks||||units on a scale||Standard Deviation|Mean
1339318|NCT01952665|Primary|Dryness|Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).|2 weeks||||units on a scale||Standard Deviation|Mean
1339319|NCT01952665|Primary|Comfort|Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|2 weeks||||units on a scale||Standard Deviation|Mean
1339320|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)|2 weeks||||hours||Standard Deviation|Mean
1339321|NCT01952665|Secondary|Rewetting Drops|Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|2 weeks||||participants|||Number
1339322|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 2 Weeks.|2 weeks||||hours||Standard Deviation|Mean
1339323|NCT01952665|Other Pre-specified|The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.|The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, >3)|Dispense||||number of trial lenses|lenses|Standard Deviation|Mean
1339324|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)|Dispense||||units on a scale|lenses|Standard Deviation|Mean
1339325|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|Dispense||||units on a scale|lenses|Standard Deviation|Mean
1339326|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|Dispense||||lenses|lenses||Number
1339327|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|Dispense||||lenses|lenses||Number
1339328|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)|Dispense||||lenses|lenses||Number
1339329|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)|Dispense||||units on a scale|eyes|Standard Deviation|Mean
1339330|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|Dispense||||units on a scale|eyes|Standard Deviation|Mean
1339331|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|Dispense||||logMAR||Standard Deviation|Mean
1339332|NCT01952665|Primary|Visual Quality|Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)|Dispense||||units on a scale||Standard Deviation|Mean
1339333|NCT01952665|Primary|Comfort at Insertion|Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).|Dispense||||units on a scale||Standard Deviation|Mean
1339334|NCT01952600|Primary|Factors That Are Most Important to Patients|Differences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.|Baseline||||% of patients|||Number
1339335|NCT01952574|Secondary|Change From Baseline in Monthly Migraine Attacks at Week 12|"A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack.~The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase – the number of migraine attacks during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine attacks.|||migraine attacks/month||Standard Error|Least Squares Mean
1339336|NCT01952574|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12|A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment. At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set) with available data at week 12.|||percentage of participants|||Number
1339337|NCT01952574|Primary|Change From Baseline in Monthly Migraine Days at Week 12|A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase – the number of migraine days during the 4-week baseline phase.|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine days.|||migraine days / month||Standard Error|Least Squares Mean
1339338|NCT01952418|Secondary|Polyp Detection Rate (Screening Exams Only)|Number of patients with polyps detected|recorded during endoscopy (immediate)|screening exams only|||Participants|||Count of Participants
1339339|NCT01952418|Secondary|Polyp Detection Rate (All Indications)|Number of patients with polyps detected|recorded during endoscopy (immediate)|all indications|||Participants|||Count of Participants
1339340|NCT01952418|Primary|Adenoma Detection Rate (Screening Exams Only)|Number of patients with adenoma detected|within 2 weeks (range of 1 day-14 days) of the endoscopy|screening exams only|||Participants|||Count of Participants
1339341|NCT01952418|Primary|Adenoma Detection Rate (All Indications)|Number of patients with adenoma detected|within 2 weeks (range of 1 day-14 days) of the endoscopy|all indications|||Participants|||Count of Participants
1339342|NCT01952366|Secondary|Number of Patients With a Diagnosis of Dementia|One year after inclusion to the study, there will be a clinical assessment of the patient including a MMSE, if possible, and to evaluate if the patients have dementia.|1 year after inclusion to the study||||Participants|||Count of Participants
1339344|NCT01952366|Primary|Depression|"Response (50% improvement on the Montgomery and Asberg Depression Rating Scale (MADRS) score) Remission (defined as score of 9 or less on the MADRS)~The MADRS is a measurement of the severity of depression and consists of 10 items rated from 0 points (no symptoms) to 6 (severe symptoms)"|Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)|Patients with complete MADRS records|||participants|||Number
1339345|NCT01952301|Primary|Keratinized Tissue Width|Change in Keratinized Tissue width|6 months|Sample size was determined using 80% power fans assuming a paired t-test of non-inferiority with a non-inferiority margin of 1.0 mm, a within-subject standard deviation of 1.0 mm, and a one-sided alpha of 0.05, resulting in a sample size of 27. To account for potential loss-to-follow-up, 30 subjects were enrolled in the trial.|||mm||Standard Deviation|Mean
1339346|NCT01952145|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.|During 26 weeks of treatment|The safety analysis set was used for analysis of this endpoint and this set included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”. Confirmed hypoglycaemic episodes were reported by 79 subjects in IdegLira arm and by 137 subjects in IGlar arm.|||Number of episodes|||Number
1339347|NCT01952145|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, week 26|FAS which included all randomised subjects was used for analysis of this endpoint. Missing values (including intermittent missing values) were imputed using LOCF method.|||Kg||Standard Deviation|Mean
1339348|NCT01952145|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|FAS was used for analysis of this endpoint. And FAS included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Percentage (%)||Standard Deviation|Mean
1339349|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 16|Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Absolute change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
1339350|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment|Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Absolute change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
1339351|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16|Absolute change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Absolute change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
1339352|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12|Absolute change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Absolute change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
1339353|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 16|Percent change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Percent change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
1339354|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 12|Percent change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Percent change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
1339355|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 12|Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Absolute change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
1339356|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at Week 16|Percent change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Percent change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
1339357|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment|Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Percent change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
1339358|NCT01952080|Primary|Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12|Percent change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Percent change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population (ITT), defined as all participants who were enrolled in the study.|||percent change||Standard Deviation|Mean
1339359|NCT01951963|Other Pre-specified|Pain Scale Rating Agreement Among Patient, Parent, and Research Staff|"FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant.~FLACC – Parents 30 Minutes Post dose~FLACC – Staff 30 Minutes Post dose~Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain."|Up to 3 hours post pain medication administration|Wong-Baker Faces scale is a self-assessment of pain Scale. FLACC Score (FLACC = Face, Legs, Activity, Crying and Consolability) is a behavioral observational pain rating scale that looks for specific behaviors and scores them. Both scales are scored 0-10 with 0 representing no pain. Lower scores are better outcomes.|||Scores on a scale||Standard Deviation|Mean
1339381|NCT01951573|Secondary|Over-refraction (OR) Monocular at Distance|OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.|||Diopters|Participants|Standard Deviation|Mean
1339360|NCT01951963|Primary|Adverse Drug Reaction|Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.|3 hours post study drug administration|Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED will be compared using unadjusted Fisher’s exact of a composite measure (≤ 1 events vs. > 1).|||Participants|||Count of Participants
1339361|NCT01951963|Primary|Cumulative Narcotic Consumption|All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.|3 hours post study drug administration|The number of subjects in each group who received at least one dose of opioids post study drug.|||Participants|||Count of Participants
1339362|NCT01951950|Primary|Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg||1 hour postoperatively||||participants|||Number
1339363|NCT01951820|Primary|Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale|The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).|2.5 minutes||||mm||Full Range|Mean
1339364|NCT01951703|Primary|Subjective Overall Vision (Using CLUE )|Contact Lens User Experience Vision scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes|||units on a scale||Standard Deviation|Mean
1339365|NCT01951703|Primary|Subjective Overall Comfort (Using CLUE )|Contact Lens User Experience Comfort scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes|||units on a scale||Standard Deviation|Mean
1339366|NCT01951651|Secondary|Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)|The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline.|6 months||||percentage change from baseline||Standard Error|Mean
1339367|NCT01951651|Secondary|Left Ventricular Ejection Fraction (LVEF)(%).|Left Ventricular Ejection Fraction following intervention as measured by magnetic resonance imaging in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the Left Ventricular Ejection Fraction study (magnetic resonance imaging) following 6 months of treatment|||percent of Left ventricular function||Standard Error|Mean
1339368|NCT01951651|Primary|Hepatic Fat Content|Hepatic fat content following intervention in patients with type 2 diabetes|6 months|One patient assigned to the glipizide treatment arm did not complete the hepatic fat content study (MRS) following 6 months of treatment|||percent of hepatic fat||Standard Error|Mean
1339369|NCT01951651|Primary|Myocardial Fat Content|Myocardial fat content following intervention as measured by magnetic resonance imaging and spectroscopy (MRS) in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the myocardial fat content study (MRS) following 6 months of treatment|||percentage of myocardium content||Standard Error|Mean
1339370|NCT01951586|Secondary|Number of Participants With Treatment-emergent Adverse Events||From first dose of study drug until 4 weeks after last dose; median exposure to study drug was 6.77 months.|All randomized participants who received at least one dose of study drug (denosumab or placebo)|||participants|||Number
1339371|NCT01951586|Secondary|Serum Denosumab Trough Levels in Participants Who Received Q4W Dosing|Serum samples were analyzed for denosumab using enzyme-linked immunosorbent assay (ELISA) following a validated procedure. The lower limit of quantification for the assay was 20 ng/mL.|Prior to dosing at day 8 and weeks 4, 8, 12, 16, 20 and 24|Randomized participants who received denosumab every 4 weeks with at least one valid denosumab concentration measurement.|||ng/mL||Standard Deviation|Mean
1339372|NCT01951586|Secondary|Serum Denosumab Trough Levels in Participants Who Received Q3W Dosing|Serum samples were analyzed for denosumab using enzyme-linked immunosorbent assay (ELISA) following a validated procedure. The lower limit of quantification for the assay was 20 ng/mL.|Prior to dosing at day 8 and weeks 3, 6, 9, 12, 15, 18, 21 and 24.|Randomized participants who received denosumab every 3 weeks with at least one valid denosumab concentration measurement.|||ng/mL||Standard Deviation|Mean
1339373|NCT01951586|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from randomization to the first observed disease progression per modified RECIST 1.1 criteria or death from any cause. Participants last known to be alive who did not experience disease progression were censored at their last imaging assessment date, last contact date if they were in the survival follow up phase, end of the study date, or the primary analysis cut-off date, whichever was first. If a participant underwent surgical resection while on study, the participant was censored at the last evaluable imaging assessment prior to the surgery.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants|||months||95% Confidence Interval|Median
1339416|NCT01950741|Secondary|Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography|ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.|12 months|Among 45 patients who completed the study, data of 6 were inadequate for the analysis. 39 patients were included in the analysis.|||percentage of patients|||Number
1339374|NCT01951586|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants with an objective response (CR or PR) or stable disease (SD) or better for at least 16 weeks achieved over the study duration. If a participant underwent surgical resection while on study, the participant was not evaluated for response after the surgery. Participants who did not meet the criteria for clinical benefit by the analysis cutoff date were considered as non-responders.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|Randomized participants with at least one baseline measurable lesion per modified RECIST 1.1.|||percentage of participants|||Number
1339375|NCT01951586|Secondary|Correlation of Tumor Tissue RANKL Expression With Objective Response Rate|"To assess whether the treatment effect on objective response rate (ORR) based on RECIST 1.1 was correlated with RANKL protein expression in tumor cells, RANKL expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANKL expression level and ORR was evaluated within each treatment group using a logistical regression model that included RANKL expression value as an independent variable and stratified by the randomization stratification factors. The odds ratio and 95% confidence interval are reported."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants with at least one baseline measurable lesion per modified RECIST 1.1 who had evaluable pre-treatment tumor RANKL expression.|||odds ratio||95% Confidence Interval|Number
1339376|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Expression With Objective Response Rate|"To assess whether the treatment effect on objective response rate (ORR) based on RECIST 1.1 was correlated with RANK protein expression in tumor cells, RANK expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm, membrane, and total was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANK expression level and ORR was evaluated within each treatment group using a logistical regression model that included RANK expression value as an independent variable and stratified by the randomization stratification factors. The odds ratio and 95% confidence interval are reported."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants with at least one baseline measurable lesion per modified RECIST 1.1 who had evaluable pre-treatment tumor RANK expression.|||odds ratio||95% Confidence Interval|Number
1339377|NCT01951586|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) based on modified RECIST 1.1 achieved over the study duration.~CR: Disappearance of all target and non target lesions, normalization of tumor marker levels and no new lesions.~PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, disappearance of target lesions with persistence of one or more non-target lesions and/or maintenance of tumor marker levels above normal limits and no new lesions.~Participants who underwent surgical resection while on study were not evaluated for response after the surgery. Participants who did not meet the criteria for an objective response by the analysis cutoff date were considered non-responders."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|Randomized participants with at least one baseline measurable lesion per modified RECIST 1.1.|||percentage of participants|||Number
1339378|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Ligand Expression With Overall Survival|"To assess whether the treatment effect on overall survival was correlated with RANK ligand (RANKL) protein expression in tumor cells, RANKL expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANKL expression level and OS was evaluated using a Cox proportional hazard models that included RANKL expression level stratified by the randomization stratification factors in the corresponding treatment group."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants who had evaluable pre-treatment tumor RANKL expression.|||hazard ratio||95% Confidence Interval|Number
1339379|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Expression With Overall Survival|"To assess whether the treatment effect on overall survival was correlated with receptor activator of nuclear factor (NF)-κB (RANK) protein expression in tumor cells, RANK expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm, membrane, and total was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANK expression level and OS was evaluated using a Cox proportional hazard models that included RANK expression level stratified by the randomization stratification factors in the corresponding treatment group."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants who had evaluable pre-treatment tumor RANK expression.|||hazard ratio||95% Confidence Interval|Number
1339380|NCT01951586|Primary|Overall Survival (OS)|Overall survival was calculated as the time from the date of randomization to the date of death from any cause. Participants last known to be alive were censored at the last contact date or the primary analysis cutoff date, whichever was first.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants|||months||95% Confidence Interval|Median
1341868|NCT01923480|Secondary|Plasma Concentration of Glycine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1339382|NCT01951573|Secondary|HC/HI Binocular VA at Distance|Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.|||logMAR||Standard Deviation|Mean
1339383|NCT01951573|Primary|High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near|Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.|||logMAR||Standard Deviation|Mean
1339384|NCT01951417|Other Pre-specified|Stinging/Burning|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
1339385|NCT01951417|Other Pre-specified|Dryness|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
1339386|NCT01951417|Other Pre-specified|Scaling|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
1339387|NCT01951417|Other Pre-specified|Erythema|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
1339388|NCT01951417|Secondary|Subject Questionnaire|Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||participants|||Number
1339389|NCT01951417|Secondary|Non-inflammatory Lesions|The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||lesions||Standard Deviation|Mean
1339390|NCT01951417|Secondary|Inflammatory Lesions|The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||lesions||Standard Deviation|Mean
1339391|NCT01951417|Primary|Total Lesion Count|The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||lesions||Standard Deviation|Mean
1339392|NCT01951170|Secondary|Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity|A tocilizumab antibody screen was performed at baseline and at the end of follow up (8 weeks after end of treatment at Week 32). A confirmatory anti-tocilizumab antibody test was performed on positive screen samples. A confirmed positive test indicates the presence of tocilizumab antibodies.|At baseline, Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||participants|||Number
1339393|NCT01951170|Secondary|Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal||Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||adverse events|||Number
1339394|NCT01951170|Secondary|Safety: Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
1339395|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Osteitis|Osteitis (bone inflammation) was assessed by MRI at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no osteitis, 1= 1-33% involvement of original articular bone, 2= 34-67% involvement of original articular bone and 3= 68-100% involvement of original articular bone. Total score was the sum of the 25 individual scores and ranged 0-75 with 0= no osteitis and 75= most severe osteitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
1339396|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Synovitis|Synovitis (synovial membrane inflammation) was assessed by MRI at baseline and Week 24. Scans of 8 joint locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no synovitis, 1= 1-33% volume enhancement, 2= 34-67% volume enhancement and 3= 68-100% volume enhancement. Total score was the sum of the 8 individual scores and ranged 0-24 with 0= no synovitis and 24= most severe synovitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
1339397|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Cartilage Loss|Cartilage loss was assessed by MRI at baseline and Week 24. Scans of 25 joints were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
1339398|NCT01951170|Secondary|Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions|Bone erosions were assessed by magnetic resonance imaging (MRI) at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-10 on an 11-point scale with 0= no erosion, 1= 1-10% erosion, 2= 11-20% erosion, and up to 10= 91-100% erosion. Total score was the sum of the 25 individual scores and ranged 0-250 with 0= no erosion and 250= most severe erosion. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
1339399|NCT01951170|Secondary|Change From Baseline in Swollen Joint Count (SJC)|SJC was counted based on 66 joints (SJC66) and based on 28 joints (SJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||swollen joints||Standard Deviation|Mean
1339400|NCT01951170|Secondary|Change From Baseline in Total Tender Joint Count (TJC)|TJC was counted based on 68 joints (TJC68) and based on 28 joints (TJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||tender joints||Standard Deviation|Mean
1339401|NCT01951170|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|The CDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as CDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) with a total CDAI score ranging from 0-76. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; Severe disease = score > 22.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
1339402|NCT01951170|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)|The SDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as SDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) + C reactive protein (CRP) in milligrams/deciliter (mg/dL) with a total SDAI score ranging from 0 to 86. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; Severe disease = score > 26.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
1339403|NCT01951170|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|The FACIT measurement system is a collection of health-related quality of life questionnaires targeted to the management of chronic illness and includes questions on physical well-being, social/family well-being, emotional well-being and functional well-being. The FACIT-F Scale measures an individual’s level of fatigue during their usual daily activities. Total scores range from 0 to 52 with lower scores representing greater fatigue, and scores below 30 representing severe fatigue. A positive change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
1339404|NCT01951170|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
1339405|NCT01951170|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|"The Physician Global Assessment of Disease Activity is the investigator's overall assessment of the participant's current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in Physician Global Assessment of Disease Activity is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
1339656|NCT01947907|Primary|E-Trough of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during Visit 1 and Visit 3 compared between the ACP-001 dose groups and to the daily rhGH group~Uncorrected E-Trough (the pre-dose efficacy response) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)||||ng/mL||Standard Deviation|Mean
1339406|NCT01951170|Secondary|Change From Baseline in Patient’s Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)|"The PGA pain VAS is the participant's overall assessment of pain. Pain is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no pain and the right-hand extreme (100 mm) is described as unbearable pain. The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
1339407|NCT01951170|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)|"PGA VAS is the participant's overall assessment of their current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
1339408|NCT01951170|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants||95% Confidence Interval|Number
1339409|NCT01951170|Secondary|Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses|A positive ACR20 response requires at least 20% improvement compared to baseline in SJC (66 joints) and TJC (68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician’s global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) acute phase reactant (C-reactive protein [CRP] - if not available, ESR was used). ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants||95% Confidence Interval|Number
1339410|NCT01951170|Secondary|Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient's global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Higher scores represent higher disease activity. DAS28-ESR remission is defined as a score < 2.6.|At Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants||95% Confidence Interval|Number
1339411|NCT01951170|Primary|Change From Baseline in Genant-modified Total Sharp Score (mTSS)|The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|From baseline to Week 24|Full Analysis Set (FAS) included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number analyzed represents the number of participants for whom the Week 24 X-ray was performed.|||units on a scale||Full Range|Median
1339412|NCT01951092|Secondary|Efficacy|Exploratory end point of PVL <200 copies at the end of the study|6 months||||participants|||Number
1339413|NCT01951092|Primary|Number of Particpatns Who Considered the Intervention Feasible and Acceptable|A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.|6 months|All 20 participants who completed the study at 6 months participated in interviews and reported that the texting intervention was feasible and acceptable.|||participants|||Number
1339414|NCT01951066|Primary|Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent|Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).|1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent||||Pearson correlation coefficient (r)|||Number
1339415|NCT01950741|Secondary|VFQ (Visual Function Questionaire)-25 Score|Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||scores on a scale||Inter-Quartile Range|Mean
1339689|NCT01946529|Secondary|Time to Progression|Median time to progression of group B patients will be estimated from the Kaplan-Meier curve.|Maximum of 11 years after the start of therapy|||||||
1339417|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/40|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||percentage of patients|||Number
1339418|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/200|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||percentage of patients|||Number
1339419|NCT01950741|Secondary|Change in Visual Acuity From Baseline to 12 Months|Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change.|Baseline and 12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||letters||Full Range|Mean
1339420|NCT01950741|Primary|Percentage of Patients Lose Visual Acuity Less Than 15 Letters|Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||percentage of patients|||Number
1339421|NCT01950663|Primary|Per Patient Referral Accuracy|Accuracy will be reported as count of participants with referral status correctly identified, sensitivity, and specificity, with ETDRS photography and reading as the gold standard.|During a single visit, implicit time, measured by the RETeval device, and ETDRS photography, will be performed to support the analysis of the accuracy of the RETeval device.|Participants with gradeable fundus photos and RETeval measurements|||Participants|||Count of Participants
1339422|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339423|NCT01950364|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, body weight, blood pressure and heart rate.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1339424|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339425|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339426|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339427|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339428|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339429|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339430|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339431|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339432|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339433|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339434|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339435|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339436|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339437|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339438|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339439|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339440|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339441|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339442|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
1339443|NCT01950364|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1339444|NCT01950364|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin|Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.|Day 1 of Cycle 1 and 3|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1339445|NCT01950364|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1339446|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 480 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339447|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339448|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339449|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339450|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339451|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339452|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339453|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339454|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339455|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339456|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339457|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339458|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339459|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339460|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339461|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339462|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339463|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339464|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339465|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339466|NCT01950364|Secondary|Serum Concentration of Total Antibody (TAb)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339467|NCT01950364|Secondary|Serum Concentrations of Antibody-drug Conjugate (ADC)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1340185|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
1339468|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).|Cycle 1: Predose|Pharmacokinetic (PK) analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
1339469|NCT01950078|Secondary|Preoperative Pressure Pain Tolerance (PTO)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say ok when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance."|30 minutes before the operation||||kg/cm2||Standard Deviation|Mean
1339470|NCT01950078|Primary|Preoperative Pressure Pain Threshold (PPT)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say pain when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold."|30 minutes before the operation||||kg/cm2||Standard Deviation|Mean
1339471|NCT01949870|Primary|The Number of Dose-limiting Toxicities|The number of dose-limiting toxicities in selumetinib in combination with cisplatin and gemcitabine|The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosing|Evaluable = completed at least 75% of planned daily doses of selumetinib at least 50% of planned dose of cisplatin/gemcitabine planned on Cycle 1 Day 8 (therefore, in total with Cycle 1 Day 1, at least 75 % of planned dose is given in Cycle 1) and has enough information to be assessed for the combination regimen dose escalation.|||Participants|||Number
1339472|NCT01949844|Primary|Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images|In this study, the approach is to use nuclear myocardial perfusion (prior PET/SPECT scans for the enrolled patients) as the comparative standard for detection of myocardial ischemia (presence of perfusion deficits). Using this approach, the acquired MR images will be analyzed to determine the diagnostic performance (specificity and sensitivity) of the improved MRI technique for detection of myocardial perfusion deficits.|Baseline only|Patients who did not have diagnostically interpretable MRI data were not analyzed.|||percentage of true cases|||Number
1339473|NCT01949545|Secondary|Number of Participants With Adverse Events (AEs)|"Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.~Adverse events were graded using National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, on a scale from 1 (mild) to 5 (death)."|From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks||||participants|||Number
1339474|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339475|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339476|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
1339477|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339478|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339479|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339480|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339481|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339482|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
1339483|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339484|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339485|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339486|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339487|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339488|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
1339489|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339490|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339491|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as all participants who had adequate carfilzomib exposure and plasma concentration versus time data for the estimation of PK parameters by a non-compartmental analysis at each time point.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339492|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||liters||Geometric Coefficient of Variation|Geometric Mean
1339493|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339494|NCT01949545|Secondary|Clearance of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||L/hour||Geometric Coefficient of Variation|Geometric Mean
1339495|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339496|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
1339497|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339510|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
1343119|NCT01903863|Secondary|Hemorrhagic and Thrombotic Complications|Complications associated with coagulation in both the patient and the pump will be collected.|ECMO course (median 198 hours)||||participants|||Number
1339498|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 56 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339499|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 56 mg/m²|The area under the curve from time zero to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339500|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 27 mg/m²||Cycle 1 day 16 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||liters||Geometric Coefficient of Variation|Geometric Mean
1339501|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339502|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
1339503|NCT01949545|Secondary|Clearance of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||L/hour||Geometric Coefficient of Variation|Geometric Mean
1339504|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
1339505|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339506|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 27 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339507|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 27 mg/m²|The area under the curve from time zero (defined as the start of carfilzomib infusion) to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as participants who received the intended carfilzomib dose (27 or 56 mg/m²) and who had plasma concentration versus time data for the estimation of each pharmacokinetic (PK) parameter by a non-compartmental analysis.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1339508|NCT01949532|Secondary|Number of Participants With Adverse Events (AEs)|"Determination of the severity of all adverse events was assessed following the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Fatal.~A Serious AE is an AE that meets one or more of the following criteria:~Death,~Life-threatening experience;~Requires in-patient hospitalization or prolongation of an existing hospitalization,~Results in persistent or significant disability/incapacity,~Is a congenital anomaly/birth defect,~Important medical events that may not result in death, be life-threatening, or require hospitalization.~Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group.|All treated participants|||participants|||Number
1339509|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
1339511|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339512|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339513|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339514|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.|||hours||Full Range|Median
1339515|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
1339516|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339517|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339518|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339519|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. T½ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.|||hours||Full Range|Median
1339520|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
1339521|NCT01949532|Secondary|Maximum Observed Plasma Concentration for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339522|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. AUC0-∞ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339523|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|"PK evaluable population; One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. n indicates the number of participants included in the analyses at each time point."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339524|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters||Geometric Coefficient of Variation|Geometric Mean
1339525|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.|||hours||Geometric Coefficient of Variation|Geometric Mean
1339526|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
1339527|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.|||hours||Full Range|Median
1339528|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
1339529|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339530|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the coefficient of correlation (R²) was < 0.8 were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339531|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339532|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters||Geometric Coefficient of Variation|Geometric Mean
1339533|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Geometric Coefficient of Variation|Geometric Mean
1339534|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
1339535|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
1339536|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
1339537|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339562|NCT01949090|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339538|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339539|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2|Carfilzomib plasma concentrations for pharmacokinetic (PK) analyses were measured by liquid chromatography with tandem mass spectrometry. The lower limit of quantitation (LLOQ) for the assay was 0.3 ng/mL.|Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. The PK evaluable population is defined as participants with sufficient carfilzomib plasma concentration versus time data for the estimation of PK parameters by non-compartmental analysis on cycle 1, day 16 and/or cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339540|NCT01949389|Primary|Completion of All 7 Modules of the Intervention|"Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable).~The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program."|on average 7 weeks||||participants|||Number
1339541|NCT01949389|Primary|Insomnia Severity Index (Total), Change From Baseline to Follow-up|"Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks)~The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia."|pre-intervention, intervention completion (expected average of 7 weeks)|The number of individuals provided access to the program and reporting baseline and follow-up data|||units on a scale||Standard Deviation|Mean
1339542|NCT01949155|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set|||percentage of Microbiological response|||Number
1339543|NCT01949155|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry measurements.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)|||percentage of ears|||Number
1339544|NCT01949155|Primary|Percentage of Participants Who Were Treatment Failures.|"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set|||percentage of treatment failures|||Number
1339545|NCT01949142|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set|||percentage of Microbiological response|||Number
1339546|NCT01949142|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)|||percentage of ears|||Number
1339547|NCT01949142|Primary|Percentage of Participants Who Were Treatment Failures|"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set|||percentage of treatment failures|||Number
1339548|NCT01949116|Secondary|Absolute Change From Baseline to Week 24 in Homing Molecule (CX3CR1+) Expression|CX3CR1+ is a cellular marker of immune activation. The outcome measured is the percentages of CX3CR1+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CX3CR1+ cells.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percent of Expression in Parent Cell||95% Confidence Interval|Mean
1339549|NCT01949116|Secondary|Absolute Change From Baseline to Week 24 in Adhesion and Activation Indices|The adhesion and activation indices of interest are the percentages of CD38+HLADR+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CD38+HLADR+ cells.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percent of Expression in Parent Cell||95% Confidence Interval|Mean
1339550|NCT01949116|Secondary|Absolute Change From Baseline to Week 24 in Monocyte Levels|Three categories of monocyte levels are presented: classical (CD14+CD16-), intermediate (CD14+CD16+), and non-classical (CD14dimCD16+). Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells that express the subset of interest.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percent of Expression in Parent Cell||95% Confidence Interval|Mean
1339551|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in D-Dimer|D-dimer (or D dimer) is a marker of coagulation activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
1339552|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in Soluble CD 163 (sCD163)|sCD163 is a marker of Macrophage activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
1339553|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in Interleukin-6 (IL-6)|IL-6 is a marker of systemic inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
1339554|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in High-sensitivity C-reactive Protein (hsCRP)|hsCRP is a marker of inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%. One single hsCRP result at week 24 was above the limit of quantification, therefore excluded from analysis.|From Baseline to week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
1339555|NCT01949116|Secondary|Change From Baseline to Week 24 in Peak Reactive Hyperemic (RH) Flow Velocity|The absolute change in peak RH flow velocity in cm/s of the brachial artery at week 24 from baseline.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||cm/s||Inter-Quartile Range|Median
1339556|NCT01949116|Secondary|Change From Baseline to Week 24 in Reactive Hyperemic (RH) Flow Rate|The absolute change in RH flow rate in cc/min of the brachial artery at week 24 from baseline.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||cc/min||Inter-Quartile Range|Median
1339557|NCT01949116|Secondary|Change From Baseline to Week 24 in Brachial Artery Resting Average Diameter|The absolute change in resting average diameter in millimeters of the brachial artery at week 24 from baseline.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||mm||Inter-Quartile Range|Median
1339558|NCT01949116|Secondary|Change From Baseline to Week 12 in Brachial Artery Resting Average Diameter|The change in resting average diameter in millimeters of the brachial artery at week 12 from baseline.|From Baseline to Week 12|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||mm||Inter-Quartile Range|Median
1339559|NCT01949116|Secondary|Change From Baseline to Week 12 in Brachial Artery FMD|The absolute change from baseline to week 24 FMD (%), defined as the maximum FMD calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter.|From Baseline to Week 12|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||Percent Dilation||Inter-Quartile Range|Median
1339560|NCT01949116|Primary|Primary Efficacy Endpoint of Change From Baseline to Week 24 in Brachial Artery Flow-mediated Vasodilation (FMD)|Flow-mediated vasodilation is defined as the maximum FMD (%) calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter. Absolute change of FMD at week 24 is calculated from baseline FMD.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||Percent Dilation||95% Confidence Interval|Mean
1339561|NCT01949116|Primary|Number of Participants Who Reached at Least One Safety Milestone Over the Duration of Study Follow-up (36 Weeks)|"Number of participants who experienced any one of the following safety milestones:~Entry CD4+ T-cell count less than 700 cells/mm^3, confirmed CD4+ decline greater than 33% of baseline AND to less than 350 cells/mm^3~Entry CD4+ T-cell count greater than or equal to 700 cells/mm^3, a confirmed CD4+ decline greater than 50% of baseline~Confirmed HIV-1 RNA Level Greater Than 200 Copies/mL in the Absence of an Interruption in ART~New or recurrent CDC category C AIDS-indicator condition~Evidence of HIV-associated infection including CMV end-organ disease, varicella zoster, EBV related clinical disease~Requirement for LDMTX discontinuation for confirmed Grade 3 or higher toxicity~Lymphoproliferative malignancies~Pulmonary toxicity which is defined as Grade 3 or 4 dyspnea, cough, shortness of breath which in the opinion of the local investigator is related to the study drug but not related to other clinical causes such as asthma, influenza, etc."|From study entry to week 36|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||Participants|||Count of Participants
1339563|NCT01949090|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339564|NCT01949090|Secondary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|An pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 42 up to Month 12|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339565|NCT01949090|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|From Day 42 up to Month 12|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339566|NCT01949090|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain|Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Anhui/1/2013 (H7N9).|At Days 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
1339567|NCT01949090|Secondary|Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9)|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Anhui/1/2013. The reference seropositivity cut-off value was ≥ 1:28.|At Days 0, 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
1339568|NCT01949090|Secondary|Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)|Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Anhui/1/2013 (H7N9).|At Days 0, 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
1339569|NCT01949090|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
1339570|NCT01949090|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/mallard/NL/12/2000. The reference seropositivity cut-off value was ≥ 1:28.|At Days 0, 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
1339571|NCT01949090|Secondary|Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)|Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21 and 42 and Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
1339572|NCT01949090|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Fold increase||95% Confidence Interval|Geometric Mean
1340186|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
1339573|NCT01949090|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9)|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
1339574|NCT01949090|Secondary|Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9)|Seroprotection (SPR) was defined as the proportion of subjects with H7N9 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
1339575|NCT01949090|Secondary|Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Titers||95% Confidence Interval|Geometric Mean
1339576|NCT01949090|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
1339577|NCT01949090|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Fold increase||95% Confidence Interval|Geometric Mean
1339578|NCT01949090|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1)|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
1339579|NCT01949090|Secondary|Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1)|Seroprotection (SPR) was defined as the proportion of subjects with H7N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
1339580|NCT01949090|Secondary|Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21, 42 and Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Titers||95% Confidence Interval|Geometric Mean
1339581|NCT01949090|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21, 42 and Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
1339582|NCT01949090|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339583|NCT01949090|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339584|NCT01949090|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339585|NCT01949090|Primary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339586|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 42.|||Participants|||Count of Participants
1339587|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 28|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 28.|||Participants|||Count of Participants
1339588|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 21|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 21.|||Participants|||Count of Participants
1339589|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 7|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 7.|||Participants|||Count of Participants
1339590|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 0|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339591|NCT01949090|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339592|NCT01949090|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1339593|NCT01949090|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|GMFR, also known as seroconversion factor (SCR) or mean geometric increase (MGI), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome was centered on the groups that received GSK2789869A vaccine.|||Fold increase||95% Confidence Interval|Geometric Mean
1339594|NCT01949090|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.|||Participants|||Count of Participants
1339595|NCT01949090|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/mallard/Netherlands/12/2000 NIBRG-63 (H7N1) (Flu A/mallard/NL/12/2000 H7N1).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.|||Participants|||Count of Participants
1339596|NCT01949051|Secondary|Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8|TNSS contains symtom scores for the four individual components (nasal congestion [NACG], rhinorrhea [RHSCR], nasal itching [NAITS] and sneezing [SNZS]), each scored on a 0 - 3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. The participants recorded their symptom scores on an e-diary. The mean score for each participant was calculated using the available diary data from the assessment periods, taking the average of non-missing data during the period. Weighted mean of the individual symptoms of theTNSS were calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1339597|NCT01949051|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|Per Protocol Population: all participants in the Intent-to-Treat Population (defined as all participants who were randomized and received >= 1 dose of study medication) and not identified as full protocol deviators with respect to criteria that were considered to impact the primary efficacy analysis. Only those participants contributing data at the|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1339598|NCT01948947|Secondary|Percent Change in Depression Score From Baseline to 1-Week Post-treatment|Subjects assessed how their headaches interfered with their mood through the Hamilton Rating Scale for Depression assessment at baseline, 1-week follow-up and 1-month follow-up. The outcome was measured by adding the score of each question on the assessment and then comparing the averaged scores at the different time points. The larger the depression score, the more severe the depression. A larger percent change in depression score indicates a change in the severity of the depression.|Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.||||percent change in score from baseline||Standard Deviation|Mean
1339599|NCT01948947|Primary|Percent Change in Persistent Headache Prevalence|The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month. The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no. The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points. A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.|Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.||||percent change from baseline||Standard Deviation|Mean
1339600|NCT01948947|Primary|Percent Change in Persistent Headache Intensity|The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results. The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.|Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.||||percent change from baseline||Standard Deviation|Mean
1339601|NCT01948947|Primary|Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)|The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.|Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.||||percent change from baseline||Standard Deviation|Mean
1339602|NCT01948908|Secondary|Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration|This outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted.|60 minutes||||participants|||Number
1339603|NCT01948908|Secondary|Observational Scale of Behavioral Distress - Revised|The Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase.|60 minutes||||units||95% Confidence Interval|Mean
1339604|NCT01948908|Primary|Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation|This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.|20 minutes||||minutes||95% Confidence Interval|Median
1339605|NCT01948830|Secondary|Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)|The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome|Baseline, Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and post-baseline value at the specific visit were included for this analysis|||Score on a scale||Standard Deviation|Mean
1339606|NCT01948830|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at|To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages.|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization.|||Percentage of participants|||Number
1339607|NCT01948830|Secondary|Change in Central Subfield Retinal Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit|Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||microns||Standard Deviation|Mean
1339608|NCT01948830|Secondary|Percentage of Participants With Fluid Free Macula Over Time up to Month 12|OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization|||Percentage of participants|||Number
1339609|NCT01948830|Secondary|The Average Number of Days Between Injections|The average dosing interval was measured as the average number of days between injections|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization|||days||Standard Deviation|Mean
1339610|NCT01948830|Secondary|The Mean Number of Treatment Frequency|The number of injections received|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization|||Number of injections||Standard Deviation|Mean
1339611|NCT01948830|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||Number of participants|||Number
1339612|NCT01948830|Secondary|Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||Number of participants|||Number
1340187|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
1339613|NCT01948830|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||Number of participants|||Number
1339614|NCT01948830|Secondary|Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit.|||Letters (EDTRS)||Standard Deviation|Mean
1339615|NCT01948830|Secondary|Average BCVA Change From Baseline to Month 12|"Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.~Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12"|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis.|||Letters (EDTRS)||Standard Deviation|Mean
1339616|NCT01948830|Secondary|Change in BCVA From Baseline to Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters|Baseline to Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.|||Letters (EDTRS)||Standard Deviation|Mean
1339617|NCT01948830|Secondary|Number of Visits Scheduled|The number of visits scheduled according to the treat and extend regimen after treatment initiation|From Month1 to Month 11|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed.|||Number of visits||Standard Deviation|Mean
1339618|NCT01948830|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.|||Letters (EDTRS)||Standard Error|Least Squares Mean
1339619|NCT01948791|Secondary|Change From Baseline in Caregiver Burden Inventory (CBI) Score|CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
1339620|NCT01948791|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score|This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency & severity of the behavior disorders, & allows rapid assessment using screening questions. 10 questions in behavior domain & 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1–4 points) and severity (range: 1–3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0–144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
1339630|NCT01948375|Primary|Proportion of Volunteers’Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.|"The primary outcome was the proportion of volunteers’perception of needle penetration between the placebo needle and the real needle in the third acupuncture session in each period.~LI4, on the dorsum of the hand, between the first and second metacarpal bones, approximately in the center of the second metacarpal bone; RN12, on the upper abdomen,4 cun above the umbilicus,on the anterior midline; BL36, on the back of the thigh,on the midpoint of the inferior gluteal crease; BL25, on the loin, 1.5 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra."|in the third acupuncture session in each period||||participants|||Number
1339621|NCT01948791|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|MMSE was used to determine patient’s eligibility to participate, is an easy & practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration & attention) & performance (recall, response to written/verbal commands, writing ability & reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient’s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: <24=abnormal; Range: <21=Increased odds of dementia; >25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, <23=abnormal for high school education, <24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline & post-baseline values were calculated|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
1339622|NCT01948791|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|ADCS-ADL is a scale based on caregiver’s assessment of patient’s activities of daily life. It is used in clinical studies on dementia & consists of 23 items and is designed to assess patient’s basic & instrumental activities of daily life, such as the abilities necessary for personal care, communicating & interacting with other people, maintaining a household, conducting hobbies & interests, & making judgments & decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or “yes” or “no” questions with separate sub-questions. Higher score & more “yes” answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient’s functions. The total score is the sum of the scores of all the items & sub-questions,& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
1339623|NCT01948791|Primary|Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)|The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimer’s disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimer’s disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, and who had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window, and had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
1339624|NCT01948518|Secondary|Change in 6 Minute Walk Distance|The change in 6 minutes walk distance from baseline one hour after receiving 20 mg of sildenafil orally will be measured.|Baseline and one hour||||feet||Standard Deviation|Mean
1339625|NCT01948518|Primary|Change in Diffusion Capacity Measured at Baseline and One Hour.|Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension|Baseline and one hour||||ml/min/mmHg||Standard Deviation|Mean
1339626|NCT01948375|Secondary|Acceptability of the Acupuncture Needle|"After the third acupuncture of each period, participants are asked to show their acceptance toward the needles with a 5-point scale: very difficult to accept, a little difficult to accept, acceptable, easy to accept, very easy to accept.~The needle acceptability between the placebo needle and real needle are compared.~Data of the acceptability of the placebo needle included rows 1-5, i.e., rows of placebo needle: very difficult to accept, placebo needle: a little difficult to accept, placebo needle: acceptable, placebo needle: easy to accept and placebo needle: very easy to accept.~Data of the acceptability of the real needle included rows 6-10, i.e., rows of real needle: very difficult to accept, real needle: a little difficult to accept, real needle: acceptable, real needle: easy to accept and real needle: very easy to accept."|in the third acupuncture session in each period||||participants|||Number
1339627|NCT01948375|Secondary|Degree of Acupuncture Pain|"The pain of acupuncture is assessed using visual analogue scale (VAS), where 0 means no pain, and 10 means the imaginable severest pain. The VAS value of each period is used to compare the difference of acupuncture pain between the placebo needle and the real needle.~A lower value represented a better outcome, which indicated that needles used induced less pain."|in the third acupuncture session in each period||||units on a scale||Standard Deviation|Mean
1339628|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Degree of Needle Sensation|"The degree of needle sensation between the placebo needle and the real needle were compared.~The data of degree of needle sensation of the placebo needle included rows 1-4,i.e,, rows of placebo needle:no, placebo needle: mild, placebo needle: moderate and placebo needle: severe.~The data of degree of needle sensation of the real needle included rows 5-8, i.e., rows of real needle: no, ‘real needle: mild, real needle: moderate, and real needle: severe."|in the third acupuncture session in each period||||participants|||Number
1339629|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Type of Needle Sensation|This questionnaire is used to collect the types and degree of needle sensation experienced by participants. Information is collected after the third acupuncture session in each period. The difference between two kinds of needles is to be analyzed.|in the third acupuncture session in each period||||participants|||Number
1339655|NCT01947907|Primary|Emax of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the daily rhGH group"|0 hours to 168 hours at Visit 3 (Week 13)||||ng/mL||Standard Deviation|Mean
1339631|NCT01948310|Secondary|Change in Total Daily Energy Expenditure|Total daily physical activity is measured via Actigraph GT3X accelerometers. Accelerometers will be worn for 7 days pre-drug, post-drug/pre-exercise (week 4) and again in the final month of the exercise intervention (week 13)|Week 1, Week 4 and Week 14|Subjects who completed the study were included in the analysis.|||kj/hr||Standard Deviation|Mean
1339632|NCT01948310|Secondary|Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire|The Treatment Satisfaction scale is one of five scales of the Seattle Angina Questionnaire. The possible range of scores is 0 to 100, with higher scores indicating better quality of life.|Baseline, Week 2 and Week 14|Subjects who completed the study were included in the analysis|||units on a scale||Standard Deviation|Mean
1339633|NCT01948310|Primary|Change in Peak Oxygen Consumption (VO2 Max)|This test involves exercising on a treadmill or bike to maximal exertion, during which the subject’s breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.|Baseline, Week 2 and Week 14|Subjects who completed the study were included in the analysis|||ml/kg/min||Standard Deviation|Mean
1339634|NCT01948193|Primary|Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.|Pre-dose 1 to one month post-dose 3|Vaccine response was assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
1339635|NCT01948193|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Injection site reactions: Tenderness, Cries when injected limb is moved, or reduced movement of injected limb; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes/24 hours or requires parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time/difficult to wake up; Appetite lost, Refuses ≥3 or most feeds/meals; Irritability, Inconsolable.|Within 7 days after each vaccine injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1339636|NCT01948193|Secondary|Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, PT and FHA antibodies by an ELISA, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titer ratios were assessed in the Per-protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1339637|NCT01948193|Secondary|Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, tetanus, PT, and FHA antibodies by an ELISA, PRP antibodies by a Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1339638|NCT01948193|Primary|Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.~Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
1339639|NCT01948193|Secondary|Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur’s DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.~Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
1339640|NCT01948141|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as the time from study entry to the first of either disease progression or death.|Time from study entry to the first of either disease progression or death, assessed up to 3 years|All treated patients|||months||95% Confidence Interval|Median
1339641|NCT01948141|Secondary|Incidence of Adverse Events (AEs)|Percentage of participants with adverse events. Incidence of Adverse Events (AEs) was Accessed by the National Cancer Institute (NCI) CTCAE Version 4.0.|Up to 30 days post-treatment|All treated and eligible patients. No statistics computed due to all patients had AEs in both groups.|||percentage of participants||95% Confidence Interval|Number
1343152|NCT01903252|Secondary|Period 3: Endoscopic Remission|Percentage of each dose group achieving an endoscopy sub score of 0|Week 38|Intent to Treat|||percentage of participants|||Number
1339642|NCT01948141|Secondary|Tumor Response Rate|Tumor Response rate was defined as the proportion of patients who had Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria. Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 3 years|All treated and eligible patients. No statistics computed due to all patients were non-response in both groups.|||percentage of participants||95% Confidence Interval|Number
1339643|NCT01948141|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from study entry to death from any cause.|From study entry to death from any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
1339644|NCT01948141|Secondary|6-month PFS Rate for Each of the FGFRI Amplified Groups (Low, Intermediate, High) in Comparison to Historical Controls|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|No comparison was done do versus historical controls because it was inappropriate due to the small number of patients available.||||||
1339645|NCT01948141|Secondary|Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|All treated and eligible patients. One participant was not done due to not enough tissue.|||percentage of participants|||Number
1339646|NCT01948141|Secondary|Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|All treated and eligible patients. One participant was not done due to not enough tissue.|||percentage of participants|||Number
1339647|NCT01948141|Primary|6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|At 6 months|All patients in FGFR1 amplified group|||percentage of participants||95% Confidence Interval|Number
1339648|NCT01948076|Secondary|Improvement in Diagnostic Ability Within the Intervention Group|"For the secondary outcome, we assessed whether there was an improvement in the diagnostic ability of those in the intervention group using traditional physical examination techniques as compared to using the ultrasound device. We compared the two arms using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent using their physical exam alone and then again after using the ultrasound. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month||||units on a scale||Inter-Quartile Range|Mean
1339649|NCT01948076|Primary|Comparison of Diagnostic Ability of the Intervention Group's Ultrasound Exam to the Control Group's Physical Exam|"The primary outcome is a comparison of the diagnostic ability of the intervention group as recorded after performing an ultrasound exam and the control group using traditional physical examination techniques. We compared the two groups using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The former is a gauge of a resident's ability to correctly identify present abnormalities while the latter is an assessment of correctly identifying a normal examination when findings are absent. The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent and how confident he or she was in their answer. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month|All residents were analyzed. There was one withdrawal due to family emergency|||units on a scale||Inter-Quartile Range|Mean
1339650|NCT01948063|Primary|CoQ10 Levels|Total CoQ10 levels (mcg/mL) at 24 hours post study drug admission.|24 hours after study drug administration||||(mcg/mL)||Inter-Quartile Range|Median
1339651|NCT01948050|Primary|Pain Intensity|"Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure Pain intensity assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2)."|Assessed at baseline and post tDCS stimulation day 5||||Points on numerical rating scale||Standard Error|Mean
1339652|NCT01947946|Primary|Asthma Exacerbations Over 48 Weeks Treatment|The number of asthma exacerbations over 48 weeks treatment will be counted|48 weeks treatment|Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.|||Number of events|||Number
1339653|NCT01947907|Secondary|Annualized Height Velocity|Annualized HV during treatment with ACP-001 or daily rhGH at the end of 6 months, for each ACP-001 dose group and for the daily rhGH dose group|Baseline to 6 months (Visit 5)||||cm/year||Standard Deviation|Mean
1339654|NCT01947907|Primary|AUEC0-168h of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the rhGH group.~Uncorrected AUEC0-168 (area under the efficacy curve from 0h-168h) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)||||h*ng/mL||Standard Deviation|Mean
1339657|NCT01947907|Primary|AUC0-168h of hGH|"As part of the following endpoint:~PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the PK profile of hGH from the daily rhGH group during Visit 1 and Visit 3~Uncorrected AUC0-168h (area under the curve from 0h to 168h) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)||||h*ng/mL||Standard Deviation|Mean
1339658|NCT01947907|Primary|Cmax of hGH|"As part of the following endpoint:~PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the pharmacokinetic (PK) profile of hGH from the daily rhGH groups during visit 1 and 3.~Uncorrected Cmax (maximum value of concentration) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)||||ng/mL||Standard Deviation|Mean
1339659|NCT01947907|Primary|Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)|Assessment of local tolerability was performed by examining injection sites (by the investigator during study visits) and on the basis of anamnestic data and records in the Patient Diary. Assessments included pain, redness, bruising, swelling, and itching. Every subject was counted only once within each symptom category.|Start of study treatment through Visit 5 (Week 27)||||Number of subjects with any symptom|||Number
1339660|NCT01947907|Primary|Incidence of Anti-hGH Neutralizing Antibody Formation|Number of subjects with positive results for anti-hGH neutralizing antibodies at two consecutive post-dose visits|Visit 2 - Visit 5||||participants|||Number
1339661|NCT01947907|Primary|Incidence of Anti-hGH Binding Antibody Formation|Number of subjects with positive results for anti-hGH binding antibodies at two consecutive post-dose visits|Visit 2 - Visit 5|Safety analysis set includes all patients who receive at least one dose of planned study medication|||participants|||Number
1339662|NCT01947855|Primary|Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment|The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.|1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28|Full analysis set|||mg*h/dL||Standard Error|Least Squares Mean
1339663|NCT01947582|Secondary|Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)|Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.|Assessed at visit 2 (week 1) and week 24||||persons|||Number
1339664|NCT01947582|Secondary|Change in Step Length Using the GAITRite Computerized Gait Analysis System|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.|Assessed at visit 2 (week 1) and week 24||||cm|||Number
1339665|NCT01947582|Secondary|Change in Impact of MS on Fatigue Using the 12-Item Walk Scale|The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.|Assessed at visit 2 (week 1) and week 24||||difference of sum of score|||Number
1339666|NCT01947582|Primary|Change in Walking Distance During 6-Minute Walk Test|Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.|Assessed at visit 2 (week 1) and week 24||||feet|||Number
1339667|NCT01947517|Secondary|Tear Meniscus Height|Meniscus height measured in mm|6 months||||mm||Standard Deviation|Mean
1339668|NCT01947517|Secondary|National Eye Institute Grading for Conjunctival Staining|The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged.|6 months||||Scores on a scale||Standard Deviation|Mean
1339669|NCT01947517|Secondary|National Eye Institute Corneal Fluorescein Staining Pattern|The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining.|6 months||||Scores on a scale||Standard Deviation|Mean
1339670|NCT01947517|Secondary|Canadian Dry Eye Assessment Score|Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms.|6 months||||scores on a scale||Standard Deviation|Mean
1339671|NCT01947517|Primary|Length of Retention||6 months||||months||Standard Deviation|Mean
1339672|NCT01947491|Primary|Percentage of Participants With Success According to the Investigator Global Assessment (IGA)|IGA of clear or almost clear|Day 15|Efficacy was only done on DFD01 Spray and Vehicle Spray. Protocol specifically noted no efficacy would be done on comparator or its vehicle.|||percentage of patients||95% Confidence Interval|Number
1339673|NCT01947335|Secondary|Incidence of Contrast-induced Nephropathy|Increase >= 0.5 mg/dl in basal serum creatinine|7 days||||percentage of participants|||Number
1339674|NCT01947335|Secondary|Major Adverse Cardiac Events|Composite of death, myocardial infarction or repeat revascularization|30 days and 6 months||||participants|||Number
1339675|NCT01947335|Primary|Total Volume of Iodine Contrast Used During Procedure|Total volume of iodine contrast administered during the index procedure.|Day 1||||ml||Inter-Quartile Range|Median
1339676|NCT01947153|Secondary|Linagliptin: AUC 0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Linagliptin:~AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1339677|NCT01947153|Secondary|Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Metformin:~AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339678|NCT01947153|Secondary|Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Linagliptin:~AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1339679|NCT01947153|Primary|Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Metformin:~Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1339680|NCT01947153|Primary|Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Linagliptin:~Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1339681|NCT01947153|Primary|Metformin: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Metformin:~AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|The subject set for the evaluation of pharmacokinetic endpoints of metformin (PKS-M): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1339682|NCT01947153|Primary|Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours)|"Linagliptin:~AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|subject set for the evaluation of pharmacokinetic endpoints of linagliptin (PKS-L): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1339683|NCT01947127|Secondary|Hospital Length of Stay|Numbers of days spent in the hospital since the emergency department arrival to hospital discharge|Patients will be followed for the duration of hospital stay, an expected average of 7 days||||Days||Inter-Quartile Range|Median
1339684|NCT01947127|Secondary|All-cause Mortality Rates|Electronic database retrieval of in- and outpatient clinical records together with telephone follow-ups to the patients or their contact personnel are employed to every case in the next 30 days after the day of presentation to the emergency department to identify the deceased cases. All-cause mortality rates of each cohort will be compared by the survival analysis.|30 days after the day of presentation to the emergency department|Four patients out of 392 patients were excluded from secondary (mortality) outcome analysis due to unknown mortality status. As a result, 388 patients (139 in high lactate group and 249 in low lactate group) were available for mortality outcome analysis.|||participants|||Number
1339685|NCT01947127|Primary|Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator|Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement.|72 hours after venous lactate measurement||||participants|||Number
1339686|NCT01946542|Secondary|Vascular Function|flow-mediated dilation (FMD)|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.||||||
1339687|NCT01946542|Primary|Exercise Tolerance|treadmill time to exhaustion, cardiopulmonary exercise test|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.||||||
1339688|NCT01946529|Secondary|Local Failure Rate|Loco-regional failure is defined as the time interval from date of start of local therapy to date of loco-regional failure. Distant failure or death prior to loco-regional failure will be considered competing events in the analyses. The cumulative incidence of loco-regional failure will be estimated using methods described in Kalbfleisch and Prentice.|Maximum of 11 years after the start of therapy|||||||
1339690|NCT01946529|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the date on study to the date of disease progression or death or the date if last follow-up. PFS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy|||||||
1339691|NCT01946529|Secondary|Overall Survival|Overall survival (OS) is defined as the time interval from the date on study to the date of death or the date of last follow-up. OS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy|||||||
1339692|NCT01946529|Primary|Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants|Response rate will be defined as the proportion of patients who achieved complete response or partial response (CR+PR) using the World Health Organization (WHO) criteria evaluated after two initial courses of temsirolimus, temozolomide and irinotecan in previously untreated patients with high risk Ewing Sarcoma Family of Tumor (ESFT). Participants who are treated in Group B with Desmoplastic Small Round Cell Tumor (DSRCT) or those who do not receive window therapy will not be included in this analysis.|at 6 weeks after start of therapy (after 2 initial courses)|Of the 17 Group B participants with high-risk ESFT, 12 received window therapy and are considered evaluable for this outcome.|||participants|||Number
1339693|NCT01946438|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.|Day 21 after vaccination|Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set.|||Titer Ratio||95% Confidence Interval|Geometric Mean
1339694|NCT01946438|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination.|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1339695|NCT01946438|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1339696|NCT01946438|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 after vaccination|Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1339697|NCT01946438|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.|Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 21 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
1339698|NCT01946425|Primary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|"Solicited injection-site reactions (6 months to <36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, >103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.~Solicited injection-site reactions (3 years to < 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all participants who received at least one dose of study vaccine.|||Participants|||Number
1339699|NCT01946425|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccine.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Titer Ratio||95% Confidence Interval|Geometric Mean
1339700|NCT01946425|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1339701|NCT01946425|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1339702|NCT01946425|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1339703|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||kg/m^2||Standard Deviation|Mean
1339704|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
1339705|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||cm||Standard Deviation|Mean
1339706|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||Centimeters (cm)||Standard Deviation|Mean
1339707|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||Kg||Standard Deviation|Mean
1339708|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145)|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||kilogram (kg)||Standard Deviation|Mean
1339709|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of >=15 microliter was required for determination of sweat chloride. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||mmol/L||Standard Deviation|Mean
1339710|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively.As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||millimole per liter (mmol/L)||Standard Deviation|Mean
1339759|NCT01945489|Secondary|Change From Baseline in the Daily Average Number of Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||micturition episodes||Standard Deviation|Mean
1339711|NCT01946412|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation was considered treatment-emergent.|Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)|Safety set included all participants who received at least 1 dose of study drug in study 109 (NCT01946412). As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||participants|||Number
1339712|NCT01946243|Primary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
1339713|NCT01946243|Secondary|Change in Reliability (Siemens Syngo.PET Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection||||Fleiss Kappa||95% Confidence Interval|Number
1339714|NCT01946243|Secondary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
1339715|NCT01946243|Secondary|Change in Reliability (MIMNeuro Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection||||Fleiss Kappa||95% Confidence Interval|Number
1339716|NCT01946243|Secondary|Change in Total Accuracy (MIMNeuro Software, All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
1339717|NCT01946243|Primary|Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
1339718|NCT01946204|Primary|Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)|MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography [CT] or magnetic resonance imaging [MRI] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.|Up to approximately 43 Months|Intent-to-Treat (ITT) population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
1339719|NCT01946204|Secondary|Time to Initiation of Cytotoxic Chemotherapy|Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.|Up to approximately 43 months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
1339720|NCT01946204|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death due to any cause.|Up to approximately 43 months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
1339721|NCT01946204|Secondary|Time to Symptomatic Progression|Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.|Up to approximately 43 Months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
1339787|NCT01945138|Secondary|Study Period: CGM AUC With Glucose> 140 mg/dL||continuous over the 72 hour investigation period||||min*mg/dL/day||Standard Deviation|Mean
1339788|NCT01945138|Secondary|Study Period: % of Time CGM BG <70 mg/dL||continuous over the 72 hour investigation period||||% of time||95% Confidence Interval|Mean
1339789|NCT01945138|Secondary|Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL|Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.|continuous over the 72 hour investigation period||||min*mg/dL/day||Standard Deviation|Mean
1339722|NCT01946204|Secondary|Progression-free Survival (PFS)|PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.|Up to approximately 43 Months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
1339723|NCT01946204|Secondary|Time to Metastasis (TTM)|Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.|Up to approximately 43 Months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
1339724|NCT01946178|Post-Hoc|Total Time Required to Deliver Treatment|The total treatment time was measured for each patient from the beginning of HIFU energy emission until HIFU energy emission stopped.|The total treatment time was measured on the day of treatment.|Total treatment times are reported for all treated patients. Total treatment times are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.|||minutes||Full Range|Mean
1339725|NCT01946178|Secondary|HIFU-related Non-Perfused Volume (NPV)|Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.|The NPV was measured between 0 and 7 days post-treatment.|HIFU-related Non-Perfused Volumes (NPVs) are reported for all treated patients in whom they were observed following treatment. NPV outcomes are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.|||cubic centimeters (cc)||Full Range|Mean
1339726|NCT01946178|Primary|Evaluation of All Adverse Events Encountered|Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.|Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).|All Adverse Device Effects are reported for the entire study population (all treated patients).|||Adverse Device Effects / patient||Full Range|Mean
1339727|NCT01946126|Secondary|Number of Visits for Headache Diagnosis|The number of visits for headache diagnosis is evaluated through the study period.|15 Months|All enrolled subjects|||Visits||Standard Deviation|Mean
1339728|NCT01946126|Secondary|Highest Number of Headache Days Per Month at a Qualifying Visit|The highest number of headache days per month are reported at a qualifying visit per the medical record.|15 Months|All enrolled subjects with data for this outcome measure|||Days||95% Confidence Interval|Mean
1339729|NCT01946126|Secondary|Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches|The number of headache days is reported at the visit with the highest number of headaches.|15 Months|All enrolled subjects|||Headache Days||95% Confidence Interval|Mean
1339730|NCT01946126|Secondary|Number of Unique Prophylactic Medications for Headache/Migraine Reported|The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.|15 Months|All enrolled subjects|||Medications||Standard Deviation|Mean
1339731|NCT01946126|Primary|Presence or Absence of Prophylactic Medication for Headache/Migraine|The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.|15 Months|All enrolled subjects|||Participants|||Number
1339732|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1||||percentage of vascular dilation||Standard Deviation|Mean
1339733|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat|||percentage of vascular dilation||Standard Deviation|Mean
1339734|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8||||percentage of vascular dilation||Standard Deviation|Mean
1339735|NCT01945970|Other Pre-specified|Endothelium-Independent Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1||||percentage of vascular dilation||Standard Deviation|Mean
1339736|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat|||percentage of vascular dilation||Standard Deviation|Mean
1339737|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Black Tea|"FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat|||percentage of vascular dilation||Standard Deviation|Mean
1339738|NCT01945970|Other Pre-specified|Diastolic Blood Pressure, Positive Control|Change in Diastolic Blood pressure|From before consumption on day 1 to before consumption day 8||||mmHg||Standard Deviation|Mean
1339739|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Positive Control|Change in systolic blood pressure|From before consumption (baseline) day 1 to before consumption day 8|Intention to treat|||mmHg||Standard Deviation|Mean
1339740|NCT01945970|Other Pre-specified|Diastolic Blood Pressure Black Tea|Change in Diastolic blood pressure|From before consumption on day 1 to before consumption day 8||||mmHg||Standard Deviation|Mean
1339741|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Black Tea|Change in Systolic blood pressure|From before consumption on day 1 to before consumption on day 8||||mmHg||Standard Deviation|Mean
1339742|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Mean
1339743|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Mean
1339744|NCT01945970|Secondary|Flow Mediated Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
1339745|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption day 1 to before consumption day 8.||||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
1339746|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
1339747|NCT01945970|Primary|Flow Mediated Dilation, Acute-upon-chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8.|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
1339748|NCT01945944|Secondary|Dead Space|in % of tidal volume, using parameters on mechanical ventilator. Dead space is a measure of how much of the lung is not able to move air into and out of the body. Higher levels of dead space reflect higher levels of lung dysfunction.|during mechanical ventilation (typically 4 days - 2 weeks)||||percentage of lung volume||Inter-Quartile Range|Median
1339749|NCT01945944|Secondary|Oxygenation|SaO2/FiO2. This is a measure of how will the lungs are providing oxygen to the body. Higher ratios reflect better lung function.|during mechanical ventilation (typically 4 days - 2 weeks)||||ratio||Inter-Quartile Range|Median
1339750|NCT01945944|Secondary|Dynamic Compliance|measured in ml/cm H20/kg using parameters on mechanical ventilator|during mechanical ventilation (typically 4 days - 2 weeks)||||mL/kg/cm-H20||Inter-Quartile Range|Median
1339751|NCT01945944|Secondary|Change in Serum Sodium From Baseline|The baseline sodium was the last level measured prior to study initiation, typically within 24hrs of study initiation. The change in blood sodium level was calculated as the difference between the mean post-enrollment sodium level during ICU care and the sodium level at enrollment.|during hospitalization (typically 4 days - 2 weeks)||||mEq/L||Inter-Quartile Range|Median
1339752|NCT01945944|Secondary|Hospital Length of Stay||during hospitalization (typically 4 days - 2 weeks)||||days||Inter-Quartile Range|Median
1339753|NCT01945944|Secondary|ICU Length of Stay||during hospitalization (typically 4 days - 2 weeks)||||days||Inter-Quartile Range|Median
1339754|NCT01945944|Secondary|Wheezing|as dichotomous outcome (yes/no) following drug administration|during mechanical ventilation (typically 4 days - 2 weeks)||||percentage of drug doses w/ wheezing|||Number
1339755|NCT01945944|Secondary|Atelectasis|"using chest x ray score. The score measures the amount of lung collapse (atelectasis) observed on a chest x-ray. For each of the 5 lung lobes, 1 point is given for linear atelectasis, 2 points for sub-segmental atelectasis and 3 points for lobar atelectasis. The range is 0-15 points, with higher scores reflecting more severe lung collapse."|during mechanical ventilation (typically 4 days - 2 weeks)||||units on a scale||Inter-Quartile Range|Median
1339756|NCT01945944|Primary|Duration of Mechanical Ventilation||typically 4 days - 2 weeks||||hours||Inter-Quartile Range|Median
1339757|NCT01945489|Secondary|Change From Baseline in the Daily Average Number of Nocturia Episodes|Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||nocturia episodes||Standard Deviation|Mean
1339758|NCT01945489|Secondary|Change From Baseline in the Daily Average Number of Urgency Episodes|The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||urgency episodes||Standard Deviation|Mean
1339790|NCT01945138|Secondary|Study Period: Percent Time BG in Range 70-140 mg/dL|Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM|continuous over the 72 hour investigation period||||% of time||95% Confidence Interval|Mean
1339791|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor Standard Deviation of BG|measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.|continuous over the 72 hour investigation period||||mg/dL||Standard Deviation|Mean
1339760|NCT01945489|Secondary|Change From Baseline in King’s Health Questionnaire (KHQ) Domain Scores|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|"Intent-to-Treat Population included all participants who were randomized to study drug, n is the number of participants with available data at the given time-point."|||score on a scale||Standard Deviation|Mean
1339761|NCT01945489|Primary|Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence|Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||incontinence episodes||Standard Deviation|Mean
1339762|NCT01945489|Primary|Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||percentage of participants|||Number
1339763|NCT01945294|Secondary|Percentage of Participants With Treatment-Related Serious AEs (SAEs)|A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.|Up to 60 weeks|The APaT includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
1339764|NCT01945294|Secondary|Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.|From TW1 through TW48|The APaT includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
1339765|NCT01945294|Secondary|Percentage of Participants With Anemia|The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
1339766|NCT01945294|Secondary|Percentage of Participants With Neutropenia|The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
1339767|NCT01945294|Secondary|Percentage of Participants With Relapse|The percentage of viral relapse (defined as confirmed HCV RNA >15 IU/mL after End-of-Treatment [EOT]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|From EOT to FW12 (up to 12 weeks)|Participants in the FAS with undetectable HCV RNA at EOT and who have data available at FW12 were included.|||Percentage of Participants|||Number
1339768|NCT01945294|Secondary|Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment|The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA <LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|The subset of the FAS population consisting of all participants treated with any study medication in Arms 1, 2, and 3 and who had undetectable HCV RNA at Week 4, Week 8, or Week 12.|||Percentage of Participants|||Number
1339769|NCT01945294|Secondary|Percentage of Participants With Undetectable HCV RNA Across Treatment|The percentage of participants with undetectable HCV RNA (HCV RNA <LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|Participants in the FAS population (consisting of all participants treated with any study medication who had undetectable HCV RNA at TW8 and were randomized to Arm 1 or Arm 2, and participants with detectable HCV RNA at TW8 in Arm 3) with available data.|||Percentage of Participants|||Number
1339770|NCT01945294|Primary|Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]|SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|Follow-up Week (FW) 12 (up to 40 weeks)|Participants of the Full Analysis Set (FAS) who were treated with any study medication, had undetectable HCV RNA at TW8, and were randomized to Arm 1 or Arm 2. Participants in Arm 3 were not included in the primary efficacy analysis as pre-specified by the protocol.|||Percentage of Participants|||Number
1339771|NCT01945281|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|8 weeks after end of study therapy (up to 146 days)|All participants as treated|||Participants|||Count of Participants
1340188|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
1339772|NCT01945281|Secondary|Percentage of Participants With Fungal-free Survival Through the End of Study Treatment|Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.|Up to 90 days|Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.|||Percentage of Participants||95% Confidence Interval|Number
1339773|NCT01945281|Primary|Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period|Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.|Up to 104 days|Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.|||Percentage of Participants||95% Confidence Interval|Number
1339774|NCT01945242|Secondary|Change From Baseline in Fasting Insulin|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||mg/dL||Standard Deviation|Mean
1339775|NCT01945242|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1339776|NCT01945242|Secondary|Percentage of Participants of Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||percentage of participants|||Number
1339777|NCT01945242|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1339778|NCT01945242|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator’s opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1339779|NCT01945242|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator’s opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
1339780|NCT01945138|Secondary|Day 28 Follow-Up: C-Peptide||Day 28 Follow-Up||||ng/mL||Standard Deviation|Mean
1339781|NCT01945138|Secondary|Day 28 Follow-Up: Average Serum BG||Day 28 Follow-Up||||mg/dL||Standard Deviation|Mean
1339782|NCT01945138|Secondary|Day 14 Follow-Up: C-Peptide||Day 14 Follow-Up:||||ng/mL||Standard Deviation|Mean
1339783|NCT01945138|Secondary|Day 14 Follow-Up: Average Serum BG||Day 14 Follow-Up||||mg/dL||Standard Deviation|Mean
1339784|NCT01945138|Secondary|Study Period: Daily Insulin Needs|Calculated as total daily dose of insulin.|Average of 3 day study period||||U/kg/day||Standard Deviation|Mean
1339785|NCT01945138|Secondary|Study Period: Morning C-peptide|A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient.|Average of 3 day study period||||ng/mL||Standard Deviation|Mean
1339786|NCT01945138|Secondary|Study Period: % of Time CGM BG > 140 mg/dL||continuous over the 72 hour investigation period||||% of time||95% Confidence Interval|Mean
1339792|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor (CGM) BG Average|Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period|continuously over the 72 hour investigational period||||mg/dL||Standard Deviation|Mean
1339793|NCT01945138|Primary|Study Period: Serum BG Standard Deviation|Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.|3 days of investigation period||||mg/dL||Standard Deviation|Mean
1339794|NCT01945138|Primary|Study Period: Average Serum BG|Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.|3 days of investigation period||||mg/dL||Standard Deviation|Mean
1339795|NCT01945112|Primary|Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot|Blister data were collected without regard to whether the foot was right or left.|within 7 days of application of tape||||Participants|||Count of Participants
1339796|NCT01945086|Secondary|Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 3=severe, on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
1339797|NCT01945086|Secondary|Percent Change From Baseline of Body Region Scores in EASI|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||percent change||Standard Deviation|Mean
1339798|NCT01945086|Secondary|Percent Change From Baseline in EASI Sign of Disease Components|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||percent change||Standard Deviation|Mean
1339799|NCT01945086|Secondary|Percent Change From Baseline in EASI Total Score|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively. LOCF method was not applied to impute the missing data.|||percent change||Standard Deviation|Mean
1339800|NCT01945086|Secondary|Number of Participants in IGA|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
1339801|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
1339802|NCT01945086|Secondary|Number of Participants With an IGA Score of “Clear” or “Almost Clear”|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
1339803|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
1339804|NCT01945086|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.|||units on a scale||Standard Deviation|Mean
1339805|NCT01945086|Secondary|Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12|The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching.|Baseline and Week 12|FAS population was used for analysis. LOCF method was used to impute the missing data. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1339806|NCT01945086|Secondary|"Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12"|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.|||participants|||Number
1339807|NCT01945086|Primary|Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90 percent [%]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 12|Full Analysis Set (FAS) included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. Last Observation Carried Forward (LOCF) method was used to impute the missing data.|||percent change||Standard Deviation|Mean
1339808|NCT01945034|Secondary|Percentage of Participants Taking Rescue Medication|Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.|Post first dose Day 1 up to Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Percentage of participants|||Number
1339809|NCT01945034|Secondary|Number of Doses of Rescue Medication Used During the First 7 Days of Dosing|Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.|Baseline up to Day 7|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Doses||Standard Deviation|Mean
1339810|NCT01945034|Secondary|Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose|Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.|Post-Dose on Day 1 up to Day 10|Data was not analyzed since <20% participants used rescue medication.||||||
1339840|NCT01944969|Primary|Tolerability|Number of withdrawals|From baseline to Week 52|26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons.|||participants|||Number
1339841|NCT01944969|Primary|Safety|Number of adverse events|From baseline to Week 52||||Adverse events|||Number
1339811|NCT01945034|Secondary|Time to First Perceptible Relief and Meaningful Relief|"Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: “Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief”. First perceptible relief was considered confirmed by meaningful relief if participant achieved both first perceptible and meaningful relief by either pressing second stopwatch or by indicating that his/her first perceptible relief was also meaningful. For “time to meaningful relief,” exact question asked was: “Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you.” Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered."|0 to 3 hours on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
1339812|NCT01945034|Secondary|Participant’s Global Assessment of Medication at End of Study|Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.|Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment. Number of participants analyzed 'N' signifies those participants who were evaluable for the measure.|||Units on a scale||Standard Deviation|Mean
1339813|NCT01945034|Secondary|Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10|Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can’t resume normal activities; 4= Moderately restricted walking due to pain and can’t resume normal activities; 5= Severely restricted walking due to pain and can’t resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
1339814|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 7 days (0-168 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
1339815|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest Over 3 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
1339816|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3|PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 6 hours on Day 1, over 2 hours on Day 3|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1339817|NCT01945034|Secondary|Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points|PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.|Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1339826|NCT01945021|Secondary|Number of Patients With a Shift in Hematology Laboratory Results From Grade </=2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose hematology laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment||||participants|||Number
1339842|NCT01944878|Secondary|The Association Between PUD and HVPG in Patients With Chronic Hepatitis||Retrospective case-control study (from 2009 to 2012, up to 3 years)||||mmHg||Inter-Quartile Range|Median
1339818|NCT01945034|Secondary|Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10|The physician assessment of the severity of the ankle injury was based on the participant’s individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1339819|NCT01945034|Secondary|Change From Baseline in Participant’s Global Assessment of Ankle Injury at Day 3 and 10|Participant’s global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1339820|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1339821|NCT01945034|Primary|Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1339822|NCT01945034|Primary|Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1339823|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. Scores on each sub-scale range from 0 - 100. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8|||units on a scale||Standard Deviation|Mean
1339824|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30)|The QLQ-C30 consists of 30 questions which are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social domains); a global health status/global QOL scale; 3 symptom scales (fatigue, pain, nausea and vomiting scales); and 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and the perceived financial burden of treatment. Scores for each sub-scale range from 0 to 100. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8|||units on a scale||Standard Deviation|Mean
1339825|NCT01945021|Secondary|Number of Patients With a Shift of Chemistry Laboratory Results From Grade </= 2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose chemistry laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment||||participants|||Number
1341869|NCT01923480|Secondary|Plasma Concentration of Glutamine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1339827|NCT01945021|Secondary|Type, Incidence, Severity, Seriousness and Relationship to Study Medications of Adverse Events (AE) and Any Laboratory Abnormalities|Incidence of patients experiencing a treatment emergent adverse events were summarized by type, incidence, severity, seriousness and relationship to study medication.|From the date of signed informed consent, then a minimum of every 4 weeks until 32 weeks, then a minimum of every 8 weeks, or until 4 weeks after last dose of treatment||||percentage of patients|||Number
1339828|NCT01945021|Secondary|Overall Survival||Assessed from date of date of the first dose of crizotinib until the date of death from any cause, assessed up to 6 months after the last subject is enrolled on the trial|OS is defined as the time from the date of the first dose of crizotinib to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.|||months||95% Confidence Interval|Median
1339829|NCT01945021|Secondary|Progression Free Survival Assessed by Independent Radiology Review|Progression Free Survival is defined as the time from the date of the first dose of crizotinib to first documentation of objective disease progression or to death on study due to any cause, whichever occurs first. Patients who had neither progression nor death without objective progression were censored at the time of data cut off.|From the date of first dose of crizotinib every 8 weeks or 12 weeks until the first documentation of objective disease progression or death||||months||95% Confidence Interval|Median
1339830|NCT01945021|Secondary|Disease Control Rate at 8 Weeks by Independent Radiology Review|The Disease Control Rate at 8 weeks is defined as the number of patients with a confirmed CR, confirmed PR, or SD at 8 weeks, respectively, according to RECIST v1.1 (as determined by IRR), relative to the total population of response evaluable patients.|Measured once at 8 weeks after the start of study treatment||||participants|||Number
1339831|NCT01945021|Secondary|Time to First Response|Time to response is defined as the time from the date of first dose to first documentation of objective tumor response (CR or PR), as assessed by Independent Radiology Review, that is subsequently confirmed. For patients proceeding from PR to CR, the onset of PR is taken as the onset of response.|From date of first dose of crizotinib every 8 weeks or 12 weeks until first documentation of objective response is observed, until 6 months after the last subject is enrolled on the trial|Analysis is based on 88 patients who achieved an objective response as assessed by Independent Radiology Review|||months||Full Range|Median
1339832|NCT01945021|Secondary|Duration of Response by Independent Review|The time from the first documentation of objective tumor response (CR or PR) according to Independent Review and that was subsequently confirmed to the first documentation of objective disease progression or to death due to any cause, whichever occurs first. It was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response and who had a subsequent event of progression or death without progression. Patients who did not meet these criteria were censored on the date of the last on-study tumor assessment.|Every 8 or 12 weeks until 6 months after the last patient was enrolled in the trial|Duration of response was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response by Independent Review and who either subsequently had objective progression or died, whichever occurred first.|||months||Standard Deviation|Mean
1339833|NCT01945021|Primary|Independent Radiology Reviewed Overall Objective Response (ORR)|Overall Objective Response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review [IRR]), relative to the total population of response-evaluable patients (n=127). Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response.|Starting from the first dose study treatment until the first documented CR or PR.||||participants|||Number
1339834|NCT01944969|Secondary|Change in Health-related Quality of Life|The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient’s wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). Due to the limited number of enrolled patients, no data were summarised for reporting and the data did not allow for any meaningful analyses.||||||
1339835|NCT01944969|Secondary|Change in Health-related Quality of Life|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).||||||
1339836|NCT01944969|Secondary|Change in Clinical Global Impression|Clinical Global Impression - Severity of illness (CGI-S) score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).||||||
1339837|NCT01944969|Secondary|Proportion of Patients in Remission|Based on a pre-specified MADRS total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients).||||||
1339838|NCT01944969|Secondary|Change in Depressive Symptoms|The Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From baseline to Week 52|None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients).||||||
1339839|NCT01944969|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.|From baseline to Week 52|all-patients treated set (APTS)|||participants|||Number
1344155|NCT01885910|Secondary|Erythema|the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
1339843|NCT01944878|Primary|The Association of HVPG and PUD in Patients With Liver Cirrhosis|"The association of hepatic vein pressure gradient that reflects portal hypertension and peptic ulcer disease in patients with liver cirrhosis was assessed statistically.~(NO specific time frame, only confined to 2009 to 2012, when the HVPG measurement was done). The Mann-Whitney test was used to evaluate the association between PUD or not and HVPG degree, by SPSS software."|Retrospective case-control study (from 2009 to 2012, up to 3 years)||||mmHg||Inter-Quartile Range|Median
1339844|NCT01944839|Primary|Mean Change in Visual Acuity From Baseline to 12 Months|The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.|12 Months||||letters||Standard Error|Mean
1339845|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
1339846|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
1339847|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
1339848|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
1339849|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
1339850|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
1339851|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
1339852|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
1339853|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the CE population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.|||participants|||Number
1339854|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the mITT population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.|||participants|||Number
1339855|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the CE population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.|||participants|||Number
1339856|NCT01944774|Primary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.|||participants|||Number
1339857|NCT01944722|Primary|Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.|Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.|Up to 14 weeks||||Participants|||Count of Participants
1339858|NCT01944722|Primary|Non-reportable Rate of the BD Onclarity™ HPV Test|Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.|Up to 14 weeks||||percentage of participants|||Number
1339859|NCT01944722|Primary|Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)|Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
1339860|NCT01944722|Primary|Positive Percent Agreement of the BD Onclarity™ HPV Assay as Compared to a Composite HPV Comparator Incorporating Results for the Digene Hybrid Capture 2 (HC2) HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)|Positive percent agreement is calculated: Number of subjects with a positive BD Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
1339861|NCT01944722|Primary|Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).|Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.|Up to 14 weeks||||ratio||95% Confidence Interval|Number
1339862|NCT01944722|Primary|Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).|Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.|Up to 14 weeks||||ratio||95% Confidence Interval|Number
1339863|NCT01944722|Primary|Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).|The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.|Up to 14 weeks||||percentage of assays||95% Confidence Interval|Number
1339864|NCT01944722|Primary|Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).|The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.|Up to 14 weeks||||percentage of assays||95% Confidence Interval|Number
1339865|NCT01944722|Primary|Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).|The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.|Up to 14 weeks||||Ratio||95% Confidence Interval|Number
1339866|NCT01944722|Primary|Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).|The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.|Up to 14 weeks||||Ratio||95% Confidence Interval|Number
1339867|NCT01944722|Primary|Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).|Negative Predictive Value is calculated: Number of subjects with a negative result for the BD Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
1339868|NCT01944722|Primary|Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).|Positive Predictive Value is calculated: Number of subjects with a positive result for the BD Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.|Up to 14 weeks|Data includes all participants with evaluable data.|||percentage of participants||95% Confidence Interval|Number
1339869|NCT01944722|Primary|Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater|Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
1339870|NCT01944722|Primary|Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater|Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
1339871|NCT01944722|Primary|Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater|Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
1339872|NCT01944722|Primary|Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater|Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
1344156|NCT01885910|Secondary|Nodule Counts|number of nodules counted|every four weeks|participants with data|||nodules||Standard Deviation|Mean
1339873|NCT01944670|Primary|Recurrent Dislocations|"To confirm that the Internal Joint Stabilizer – Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation.~The study is deemed a success if the at least 75% of patients do not have a recurrent dislocation while using the IJS-E or after removal of the IJS-E."|8 months (6 month post-explant)|Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.|||Participants|||Count of Participants
1339874|NCT01944670|Primary|Broberg Morrey Functional Rating|"To confirm that the Internal Joint Stabilizer – Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation.~The study is deemed a success if the at least 75% of patients receive a Broberg Morrey Functinoal Rating of Fair or better."|Eight months (6 months post-explant)|Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.|||Participants|||Count of Participants
1339875|NCT01944631|Secondary|Patient Overall Assessment of Efficacy|"Patient overall assessment of efficacy was assessed by the question How effective was the treatment in relieving your common cold symptoms? at day 10. A 5-point scale was used (0=poor, 1=fair, 2=good, 3=very good, 4=excellent)."|Day 10|FAS|||percentage of participants|||Number
1339876|NCT01944631|Secondary|Duration of the Cold|"Duration of the common cold was assessed by the question Do you still have a cold? at the end of each treatment day. The duration of the cold was defined as ended by the first day of a No answer to this daily question."|Baseline up to 10 days|FAS|||days||95% Confidence Interval|Median
1339877|NCT01944631|Secondary|Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The Area under the curve (AUC) over the 10-day period for the total symptom score (AUC-TSS 1-10) was calculated as the sum of the TSS calculated on each day from day 1 to day 10. AUC-TSS 1-10 ranges from 0 (no symptoms) to 270 (severe symptoms)."|Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10|FAS|||units on a scale * days||Standard Error|Least Squares Mean
1339878|NCT01944631|Secondary|Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)|"The mean of the sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing).~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean of the sum of 5 single local common cold symptom scores over days 2 to 4 was calculated as (LSS2 + LSS3 + LSS4)/3 where LSS2, LSS3 and LSS4 are the local common cold symptom scores calculated for days 2, 3 and 4 respectively. LSS2-4 ranges from 0 (no symptoms) to 15 (severe symptoms)."|Days 2, 3 and 4|FAS|||units on a scale||Standard Error|Least Squares Mean
1339879|NCT01944631|Secondary|Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)|"The mean of the sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness).~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean of the sum of 3 single systemic common cold symptom scores over days 2-4 was calculated as (SSS2 + SSS3 + SSS4)/3 where SSS2, SSS3 and SSS4 are the systemic common cold symptom scores calculated for days 2, 3 and 4 respectively. SSS2-4 ranges from 0 (no symptoms) to 9 (severe symptoms)."|Days 2, 3 and 4|FAS|||units on a scale||Standard Error|Least Squares Mean
1339880|NCT01944631|Primary|Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms)."|Days 2, 3 and 4|Full analysis set (FAS) which included all randomised patients who used at least one dose of trial treatment, who provided a baseline total symptom score (TSS) as well as any post-treatment data for the primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
1339881|NCT01944462|Secondary|Pharmacist Satisfaction|Pharmacists who participated in the intervention were surveyed to determine their satisfaction with the program, including: 1) satisfaction with live action skit, 2) belief that PPPP was successful in educating participants, 3) belief that PPPP was successful in building trust in pharmacists among participants, 4) belief that PPPP was successful in increasing acceptance of pharmacists as immunizers, and 5) belief that PPPP will decrease barriers to vaccination among participants.|3 months||||Participants|||Count of Participants
1339882|NCT01944462|Secondary|Intervention Cost|"Measures PPPP intervention costs per participant. Consists of total program costs divided by number of participants. Value reported is the per-participant cost with measure type number."|3 months||||$/participant|||Number
1339883|NCT01944462|Secondary|Satisfaction With PPPP|Satisfaction with PPPP was measured as participants' overall satisfaction with the content of PPPP, extent to which the participant felt engaged, and belief that the program helped them learn about pneumonia and the vaccination.|3 months|Intention-to-treat (ITT) sample|||Participants|||Count of Participants
1339884|NCT01944462|Secondary|Activation|Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months.|3 months|Intention-to-Treat (ITT) sample, subset not reporting positive history of pneumococcal vaccination at baseline|||Participants|||Count of Participants
1339885|NCT01944462|Secondary|Trust in Pharmacists as Vaccine Providers|Trust in pharmacists as vaccine providers were measured by comparing responses to the trust items in the baseline, post-test (immediately following intervention), and 3-month assessments. Trust items were coded on a 4-level Likert scale, with lower values corresponding to higher agreement with the trust statements (therefore a lower mean response indicates greater trust). Minimum possible score was 1 (indicating complete trust in pharmacists as vaccine providers) and maximum possible score was 4 (indicating complete lack of trust in pharmacists as vaccine providers).|Baseline, post-test (immediately following intervention), 3 months|Intention-to-Treat (ITT) sample|||units on a scale||Standard Deviation|Mean
1339886|NCT01944462|Primary|Knowledge and Awareness of Pneumococcal Disease|"Change in knowledge and awareness of pneumococcal disease over time were assessed for the following domains: susceptibility to infection, symptoms of disease, severity of illness, and vaccination with an emphasis on vaccine efficacy, safety, and eligibility. Assessments at baseline, post-test (immediately following intervention), and 3 months using the Pneumonia Knowledge Questionnaire, an instrument developed by investigators to assess participants' knowledge and awareness in the domains of interest. Instrument consists of 5 mark all that apply items and one mark the best response item. Scores range from 0 (no correct responses) to 28 (all responses correct), with a higher score value corresponding to better knowledge and awareness."|Baseline, post-test, 3 months|Intention-to-treat (ITT) sample|||scores on a scale||Standard Deviation|Mean
1339887|NCT01944345|Secondary|Radiological Assessment|Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated|Post-operative follow up|26 (of 30) Cervical Patients 30 (of 39) Lumbar Patients|||participants|||Number
1339888|NCT01944345|Primary|Change in VAS Pain|"VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6.~VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means ‘no pain’ and a ten (10) means 'worst imaginable pain'"|Pre-operative and Post-operative 12 months|Total subjects: 30 Cervical subjects, 39 Lumbar subjects. VAS PAIN SEVERITY SCALE ranges from 0-10. Zero = no pain, 10 - worst imaginable pain|||Units on a scale 0-10||Standard Deviation|Mean
1339889|NCT01944345|Primary|Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50|ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability >34 Complete disability|Pre-operative and Post-operative 12 months post-operative|Combined cervical and lumbar patients: 30 cervical, 39 lumbar. Mean ODI/NDI was calculated for all patients at preop and 12 month.|||Units on a scale 0-50||Standard Deviation|Mean
1339890|NCT01944319|Secondary|Bacteriological Success Rate|"The bacterial success or failure will be evaluated at the end of meropenem therapy.~Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence."|At the end of meropenem therapy, an average of 10 days.||||participants|||Number
1339891|NCT01944319|Secondary|Amount of Used Antibiotics|Record the amount of antibiotics usage during antibiotic therapy|participants will be followed for the duration of antibiotic therapy, an average of 10 days||||grams||Inter-Quartile Range|Median
1339892|NCT01944319|Primary|Clinical Success Rate|"The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy.~Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy.~Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy."|One week after antibiotic therapy finished.||||participants|||Number
1339893|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain|24 hours post-surgery||||units on a scale||Full Range|Median
1339894|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain – 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting|18 hours post-surgery||||units on a scale||Full Range|Median
1339895|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain – 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting|12 hours post-surgery||||units on a scale||Full Range|Median
1339896|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain|6 hours post-surgery||||units on a scale||Full Range|Median
1339897|NCT01944059|Secondary|HIT-6|Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.||||||
1339898|NCT01944059|Secondary|Percent Change in Migraine and Headache Frequency|The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.||||||
1339899|NCT01944059|Primary|Number of Migraine/Headache Days|The primary outcome measure will be the frequency of migraine and all headache days in the Theramine active group versus the Theramine placebo group during the treatment period.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.||||||
1339900|NCT01943864|Secondary|Number of Participants With Independent Radiologist Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event. Only 1 participant reached PR therefore estimated time to response cannot be presented. At the data cut off, this patient is censored. Therefore, the observed value of duration of response is unknown.|||Participants|||Number
1339901|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event.|||Participants|||Number
1339902|NCT01943864|Secondary|Number of Weeks Until Time to Response Assessed With Independent Radiologist|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.|Up to Week 37|ITT Population. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.|||Weeks|||Number
1339903|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Time to Response|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.||||||
1339904|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Independent Radiologist Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Independent Radiologist assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.|||Participants|||Number
1339905|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Investigator Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Investigator assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.|||Participants|||Number
1339906|NCT01943864|Secondary|Number of Participants With Overall Survival|Overall Survival (OS) is defined as the interval of time (in weeks) between the date of randomization and the date of death due to any cause. For participants that did not die, time of death was censored at the date of last contact. The date of death was taken from that recorded on the Record of Death page. Death on study due to any cause was included. One year OS was calculated from Kaplan-Meier estimates.|Up to Week 39|ITT Population.|||Participants|||Number
1339907|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Independent Radiologist|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the independent radiologist. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.|||Participants|||Number
1339908|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Investigator|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the Investigator. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.|||Participants|||Number
1339909|NCT01943864|Secondary|Change From Baseline in Oxygen Saturation (SpO2)|Oxygen Saturation was measured at Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32 and Week 36. For records occurring after baseline, change from baseline was calculated as the post baseline value minus the baseline value. When either the baseline or visit value was missing, the change from baseline was considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Percent oxygen saturation||Standard Deviation|Mean
1339928|NCT01943565|Secondary|Number of Patients With Visual Disturbances|IT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported.|24hrs post administration of IT hydromorphone||||Participants|||Count of Participants
1339929|NCT01943565|Secondary|Number of Patients With Hypothermia (Body Temperature < 95F/35C)|intrathecally administered opioids can cause hypothermia (body temperature <95F/35C)|24hrs post administration of IT hydromorphone|One 25 mcg patient was missing data on this measure|||Participants|||Count of Participants
1339910|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Pulse Rate|Pulse rate was categorized as Decrease to <60, Change to Normal or No Change, and Increase to >100. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339911|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure was measured after sitting for at least 5 minutes. Systolic blood pressure (SBP) was categorized as: Grade 0 (<120), Grade 1 (>=120-<140), Grade 2 (>=140-<160) and Grade 3 (>=160). Diastolic blood pressure (DBP) was categorized as Grade 0 (<80), Grade 1 (>=80-<90), Grade 2 (>=90-<100), and Grade 3 (>=100). Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339912|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Body Temperature|Body temperature was categorized as Decrease to <=35; Change to Normal or No Change and Increase to >=38. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339913|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Carcinoembryonic Antigen Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for carcinoembryonic antigen (CEA). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339914|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Hematology Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for basophils, eosinophils, and monocytes. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339915|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Prothrombin Time Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for prothrombin time (PT). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339916|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Clinical Chemistry Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for cancer antigen 19-9 (CA 19-9), chloride, lactate dehydrogenase (LDH), and urea. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339930|NCT01943565|Secondary|Patients With Nausea and Vomiting Requiring Rescue Medication|IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication.|24hrs post administration of IT hydromorphone|One 25 mcg patient was missing data on this measure|||Participants|||Count of Participants
1339917|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for hemoglobin, lymphocytes, neutrophils, platelets, and leukocytes. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339918|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Coagulation Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for activated partial thromboplastin time (APTT) and prothrombin time (PT). A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339919|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Clinical Chemistry Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for albumin, alkalaine phosphatase (AP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatine kinase (CK), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and phosphate. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
1339920|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker Surfactant Protein D|Interstitial lung disease marker Surfactant Protein D assessments were carried out at Baseline (Day 1), Week 12, and Week 28|Baseline, Week 12, and Week 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Micrograms per litre (µ/L)||Standard Deviation|Mean
1339921|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker KL-6|Interstitial lung disease markers KL-6 assessments were carried out at Baseline (Day 1), Week 12, Week 20, Week 24, Week 28, Week 32, and Week 36|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed.|||Units/milliliter (U/mL)||Standard Deviation|Mean
1339922|NCT01943864|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or Protocol-Specific SAEs|until 26-Feb-2016|ITT Population.|||Participants|||Number
1339923|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Independent Radiologist Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Twelve week non-progressive disease (PD) at Week 12 was evaluated by computed tomography. Non- PD was calculated as the sum of complete response (CR), partial response (PR), and stable disease (SD).|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.|||Participants|||Number
1339924|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Investigator Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease(PD), At least a 20% increase in the sum of the diameters of target lesions. Non-PD = CR + PR + SD.|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.|||Participants|||Number
1339925|NCT01943565|Secondary|Intraoperative Vasopressor Use: Phenylephrine Equivalents|"IT (intrathecal ) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely).~Total intraoperative vasopressor use will be reported for phenylephrine equivalents."|Intraoperatively (at time of operation)|One 25 mcg patient is missing data on this outcome|||mcg||Standard Deviation|Mean
1339926|NCT01943565|Secondary|Intraoperative Vasopressor Use: Ephedrine Equivalents|IT (intrathecal) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for ephedrine equivalents.|Intraoperatively (at time of operation)|One 25 mcg patient is missing data on this outcome|||mg||Standard Deviation|Mean
1339927|NCT01943565|Secondary|Number of Patients With Pruritus|IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded.|24hrs post administration of IT hydromorphone|One 25 mcg patient is missing data on this outcome|||Participants|||Count of Participants
1339931|NCT01943565|Secondary|Oxygen Saturation, Need for Supplemental Oxygen|Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice).|24hrs post administration of IT hydromorphone|One 25 mcg patient is missing data on this outcome|||percentage oxygenated haemoglobin||Standard Deviation|Mean
1339932|NCT01943565|Primary|24hr Post-partum IV Opioid Requirement|Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements.|24hrs after administration of intrathecal hydromorphone|One 25 mcg patient is missing data on this outcome|||mg||Standard Deviation|Mean
1339933|NCT01943552|Secondary|Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery|Number of patients with at least one main post-operative pulmonary complications (including pneumonia, atelectasis and acute respiratory failure) within three weeks after the surgery. Post-operative pneumonia was defined by the presence of the following criteria: persistent lung infiltrate on chest X-ray or chest computerized tomography (CT)-scan, white blood cell count >10,000 /mm3 and fever. Post-operative atelectasis was diagnosed by presence of atelectasis affecting one lobe or several lobes in chest X-ray test or chest CT-scan. Post-operative acute respiratory failure was defined by the presence of: PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg while breathing air or other evidences which were considered as respiratory failure by investigators.|From surgery to 3 weeks post surgery, up to 21 days|Surgery complete set (SCS): All patients who completed surgery.|||Participants|||Number
1339934|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial carbon dioxide pressure (PaCO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||mmHg||Standard Error|Least Squares Mean
1339935|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): Oxygen saturation|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||Percentage of Oxygen||Standard Error|Least Squares Mean
1339936|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial oxygen pressure (PaO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||mmHg||Standard Error|Least Squares Mean
1339937|NCT01943552|Secondary|Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FVC were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At Visit 1, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At Visit 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FVC each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||ml||Standard Error|Least Squares Mean
1339938|NCT01943552|Primary|Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced expiratory volume in 1 second (FEV1) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FEV1 were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At screening visit, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At treatment day 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FEV1 each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS): All patients in the treated set who had observed analysable data in at least one efficacy endpoint. (Only patients with observed cases (OC) values were analysed)|||ml||Standard Error|Least Squares Mean
1339939|NCT01943539|Other Pre-specified|Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28|"TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and D' (D Prime) using the following formula:~API = Response Time Z score (Half 1) + D’ Z score (Half 2) + Variability Z score (Total) + 1.80~where Response Time is the average time it takes to respond correctly to a target, d’ (D Prime) score is a response discriminability score reflecting the ratio of hits to “false alarms”, and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.~The calculation for difference in TOVA API was API at Baseline (Day 0) minus API at Day 28."|Day 0 and Day 28|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Cumulative z-score||95% Confidence Interval|Mean
1340189|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
1339940|NCT01943539|Secondary|Time Spent Completing the Intervention|Time spent on completing the intervention is based on the prescribed therapy of 800 total minutes, or 13.3 hours, over the course of 28 days (7 sessions of EVO per day for 5 days per week for 4 weeks with each session lasting approximately 5.7 minutes long).|28 days|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Hours||Standard Deviation|Mean
1339941|NCT01943539|Primary|Number of Participants With Non-Treatment Related Adverse Events|Another objective of this study is to evaluate the safety of EVO game play based on treatment-emergent adverse events (TEAEs) that may occur during this 28-day period of time.|Day 0 through Day 28 of the study|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Participants|||Count of Participants
1339942|NCT01943539|Primary|Reaction Time in EVO Gameplay|EVO employs a perceptual discrimination attention/memory task as well as a continuous visuomotor “driving” task. Subjects were instructed to target a pre-specified stimulus, and ignore all other stimuli while navigating a road-like course. Reaction time was measured as the time between the initial presentation of the pre-specified target and when the subject tapped the tablet screen. Longer reaction times indicated a larger deficit in multitasking.|28 days|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Reaction time (ms)||Standard Deviation|Mean
1339943|NCT01943474|Secondary|Patient Satisfaction With Overall IV Performance|Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At IV removal (usually after 1-7 days of IV dwell time)||||units on a scale||Standard Deviation|Mean
1339944|NCT01943474|Secondary|Patient Satisfaction Comfort Comparison|Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.||||units on a scale||Standard Deviation|Mean
1339945|NCT01943474|Secondary|Adverse Events|Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.|During and post IV catheter placement until study exit (maximum of 6 months).||||percentage of participants|||Number
1339946|NCT01943474|Secondary|Clinician Satisfaction|Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At completion of study after all patients have been enrolled (approximately 6 months from study initiation)||||units on a scale||Full Range|Mean
1339947|NCT01943474|Secondary|Patient Satisfaction At Insertion|Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At catheter insertion, initial 3-15 minutes after insertion procedure completed.||||units on a scale||Standard Deviation|Mean
1339948|NCT01943474|Secondary|Catheter Dwell Time|Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days.|Study Exit/At catheter removal (~ up to 7 days)||||hours||Standard Deviation|Mean
1339949|NCT01943474|Secondary|Complications of Peripheral IV Therapy|Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (~ up to 7 days).|From during to post IV catheter placement up to study exit (~ up to 7 days)||||percentage of participants||95% Confidence Interval|Number
1339950|NCT01943474|Secondary|Completion of IV Therapy|Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days).|Study exit/At catheter removal (~ up to 7 days)||||percentage of participants||95% Confidence Interval|Number
1339951|NCT01943474|Primary|First Attempt Success Rate With Peripheral IV Catheter Placement|The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.|At catheter placement, an expected average of 10 minutes||||percentage of participants||95% Confidence Interval|Number
1339952|NCT01943435|Other Pre-specified|Sense Wear Armband|Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions.|Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).|Analysis performed on all randomized participants and linear mixed models were used to account for missing data.|||minutes per day||Standard Deviation|Mean
1339953|NCT01943435|Secondary|Self Paced Walking Test (SPWT)|Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters.|Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).|Analysis performed on all randomized participants and linear mixed models were used to account for missing data.|||meters||Standard Deviation|Mean
1339954|NCT01943435|Primary|Swiss Spinal Stenosis (SSS) Questionnaire Score|Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks.|Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).|Analysis performed on all randomized participants and linear mixed models were used to account for missing data.|||units on a scale||Standard Deviation|Mean
1339955|NCT01943344|Other Pre-specified|Performance|Assessed by technical success rate for the VIVASURE CLOSURE DEVICE™|up to 3 month of implantation|||||||
1339956|NCT01943344|Secondary|Minor Vascular Complications Directly Related to Device|Incidence of minor complications directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, as defined by VARC-2.|up to 3 months from implantation|||||||
1339957|NCT01943344|Primary|Major Vascular Complications Directly Related to Device|Incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2) is no worse than those associated with cut-down and sutured close.|up to 3 Months of implantation||||participants|||Number
1339958|NCT01943292|Secondary|Evaluate the Efficacy (Response Rate and Progression-free Survival) of Subjects Treated With Defactinib (VS-6063).|Response rate and progression-free survival, as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1|Every 8 weeks up to end of treatment, an expected average of 12 weeks|||||||
1339959|NCT01943292|Secondary|Assess the Pharmacokinetics, Metabolism and Elimination of Defactinib (VS-6063) in Plasma and Urine.|PK parameters, including but not limited to plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2. Total 24-hour urine output will be collected in conjunction with PK sampling to assess the elimination of defactinib (VS-6063) and its potential metabolites.|Time points at Day 1 and Day 15 in Cycle 1|||||||
1339960|NCT01943292|Secondary|Define the Maximum Tolerated Dose (MTD), if Achieved, and Establish the Recommended Phase 2 Dose (RP2D) of Defactinib (VS-6063) in Japanese Subjects.|The RP2D will be determined based on the MTD of defactinib (VS-6063) as determined by number of participants with dose limiting toxicities (DLTs) related to defactinib.|From start of treatment to end of cycle 1 (21 day cycles)||||mg|||Number
1339961|NCT01943292|Primary|Assess the Safety and Tolerability of Defactinib (VS-6063) in Japanese Subjects With Non-hematologic Malignancies|"A composite by dose level to include incidence of AEs, SAEs, dose interruptions and dose reductions as a measure of safety and tolerability. Abnormal Clinical significant laboratory results, ECG measurements, vital signs measurement, physical examination findings, and ECOG performance status were captured as adverse events.~The severity of AEs were evaluated according to CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03"|From start of treatment to end of treatment, an expected average of 12 weeks||||participants|||Number
1339962|NCT01943110|Secondary|Proportion of Injections With Safety Events|The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|Within 30 minutes and within 48 hours of injection||||percentage of injections|Participants||Number
1339963|NCT01943110|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.|1 day||||Injections|Participants||Number
1339964|NCT01942785|Primary|CGI-I Score at Week 6 Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression - global improvement CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339965|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339966|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Subgroup analyses were performed for the change from Baseline to Week 6 in MADRS total score based on the patients’ BIS-11 total score at Baseline. The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1340037|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score|The Children's Global Assessment Scale (C-GAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.|Baseline (Day 1) and Day 43||||units on a scale||Standard Error|Mean
1339967|NCT01942785|Primary|Change From Week 6 to Week 10 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
1339968|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
1339969|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
1339970|NCT01942785|Primary|Change From Week 6 to Week 10 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provide information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis.|||units on a scale||Standard Error|Mean
1339971|NCT01942785|Primary|Change From Week 6 to Week 10 in Delay Discounting - MCQ Scores|The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provide an estimate of the patient’s discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.|||log-transformed units on a scale||Standard Error|Mean
1339972|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week, using verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.|||units on a scale||Standard Error|Mean
1339973|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The patient rates the extent to which they have suffered from these symptoms. Each subscale has verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. One additional question assesses number of days impaired by irritability over the period. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
1339974|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - EDT DRT Score|DRT consists of 60 choices between an immediate reward or a higher delayed reward. The number of impulsive choices will be a continuous variable estimated from how many immediate choices based on 60 possible. The number ranges between 0 and 60, with a higher value indicating more impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.|||units on a scale||Standard Error|Mean
1339975|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed EDT DPDT Scores|DPDT consists of approximately 110 choices between an immediate reward or a higher delayed reward, and between an immediate reward or a higher reward that only comes with a certain probability. The tasks are scored independently of each other and do not yield a total score. There will be two derived variables from this task; a delayed discounting rate and a probability discounting rate. The delay discounting value takes values from 0 and up, a higher delay discounting value indicates greater impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.|||log transformed units on a scale||Standard Error|Mean
1341870|NCT01923480|Secondary|Plasma Concentration of Glutamic Acid||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1339976|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Total Score|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ consists of 92 items which form the basis for the four subscales: depression, anxiety, anger-hostility, and somatic; of which 68 items indicate symptoms (symptom subscales) and 24 items are antonyms of some of the symptoms and indicate well-being (well-being subscales). A “yes” or “true” response on the symptom subscales scores 1, and a “no” or “false” on the well-being subscales scores 1. The maximum score for each symptom subscale is 17, and the maximum score for each well-being subscale is 6. The score of each subscale ranges from 0 to 23 (the sum of the symptom subscale and the well-being subscale). A higher score indicates more distress. The total score ranges from 0 to 92. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339977|NCT01942785|Primary|CGI-I Score at Week 6|The Clinical Global Impression - global improvement CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|Full-analysis set (FAS), this endpoint presents descriptive statistics for CGI-I based on patients who have CGI-I score observed at Week 6; the number of participants analysed is therefore smaller than the defined FAS.|||units on a scale||Standard Error|Mean
1339978|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339979|NCT01942785|Primary|Change From Baseline to Week 6 in CPFQ Total Score|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339980|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339981|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339982|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Total Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 consists of 30 items assessing the symptoms of depression, as well as commonly associated symptoms (for example, anxiety, irritability), and topics relevant to melancholic or atypical features; the patient rates only one of the 2 items assessing appetite (decreased or increased), and only one of the 2 items assessing weight (loss or gain). Each of the items is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe). The total score is the sum of the 28 scored items, and ranges from 0 to 84, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339983|NCT01942785|Primary|Shift From Baseline to Week 6 in Anger Attacks (AAQ)|The Anger Attacks Questionnaire (AAQ) is a patient-rated scale designed to assess the presence of anger attacks over a period of time. The AAQ consists of 7 items. Patients are classified as having anger attacks when exhibiting the following 4 criteria: 1) irritability, 2) overreaction to minor annoyances, 3) occurrence of anger attacks (at least one of which occurred within the period), and 4) experienced 4 or more specific symptoms during at least one of the attacks. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS) and OC. Only patients who have both baseline and Week 6 data observed were included; the number of participants analysed is therefore smaller than the defined FAS.|||participants|||Number
1339984|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339985|NCT01942785|Primary|Change From Baseline to Week 6 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339986|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed MCQ Scores|The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ‘‘Would you prefer $27 today or $50 in 21 days?”). The answers provide an estimate of the patient’s discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||log-transformed units on a scale||Standard Error|Mean
1339987|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Item 6 Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 item 6 measures mood (irritable) and is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe) with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339988|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339989|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1339990|NCT01942733|Primary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) assesses the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1339991|NCT01942733|Primary|Change From Baseline to Week 8 in BRIAN Total Score|The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) is a clinician-rated scale designed to assess biological rhythms. The BRIAN consists of 18 items divided in 4 subscales: sleep (5 items), activity (5 items), social (4 items), and eating pattern (4 items). Each item is rated on a scale from 1 (no difficulties) to 4 (serious difficulties). The total score of the 18 items ranges from 18 to 72, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1339992|NCT01942733|Primary|Changes From Baseline to Week 8 on Number of Awakenings (NAW) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number of events||Standard Error|Mean
1339993|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Efficiency (SE) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of time||Standard Error|Mean
1339994|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Actigraphy (ACT) Parameters|The key ACT parameters assessed were the total sleep time (ACT TST), wake-time after sleep onset (ACT WASO), sleep onset latency (ACT SOL), sleep efficiency (ACT SE), and the number of awakenings (ACT NAW). The results for ACT TST, ACT WASO, and ACT SOL are presented separately from ACT SE, and from ACT NAW, due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes||Standard Error|Mean
1340038|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score|The Clinical Global Impression-Improvement (CGI-I) Score is a clinician rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.|Baseline (Day 1) and day43||||units on a scale||Standard Error|Mean
1339995|NCT01942733|Primary|Percentage of MADRS Remitters at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Remission was defined as a MADRS total score ≤10 and a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of patients|||Number
1339996|NCT01942733|Primary|Percentage of MADRS Responders at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Response was defined as a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of patients|||Number
1339997|NCT01942733|Primary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) scale assesses the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1339998|NCT01942733|Primary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1339999|NCT01942733|Primary|Changes From Baseline to Week 8 in Circadian and Biological Rhythm|The parameters used to assess circadian and biological rhythm were the time to peak cortisol concentration, time to dim-light melatonin onset (DLMO) and phase angle. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes||Standard Error|Mean
1340000|NCT01942733|Primary|Change From Baseline to Week 8 in CPFQ Total Score|The Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1340001|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s Scores (Noon)|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1340002|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Morning) Score|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1340003|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Evening) Score|The Bond-Lader Visual Analogue Scale – Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1340004|NCT01942733|Primary|Changes From Baseline to Week 8 in Number of Lapses as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number||Standard Error|Mean
1340005|NCT01942733|Primary|Changes From Baseline to Week 8 in Response Speed as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||speed (per second)||Standard Error|Mean
1340006|NCT01942733|Primary|Change From Baseline to Week 8 on ESS Total Score|The Epworth Sleepiness Scale (ESS) is a is a patient-rated scale designed to measure daytime sleepiness. The ESS consists of 8 items describing different situations/activities and the patients rate the chance of them dozing off or falling asleep when they are in these situations. Each item is rated on a 4-point scale from 0 (would never dose) to 3 (high change of dozing). The total score of the 8 items ranges from 0 to 24, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1340007|NCT01942733|Primary|Change From Baseline to Week 8 in ISI Total Score|The Insomnia Severity Index (ISI) is a patient-rated scale desgined to measure the patient’s perception of his/her insomnia. The ISI comprises 7 items: difficulty falling asleep, difficulty staying asleep, problems waking up early in the morning, satisfaction with current sleep pattern, interference with daily functioning, how much others notice the sleep problem impairs quality of life, and distress caused by the sleep problem. Each of the 7 items is rated on a 5-point scale from 0 (best situation) to 4 (worst situation). The total score of the 7 items ranges from 0 to 28, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
1340008|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography (Continued)|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes||Standard Error|Mean
1340009|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non–rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of total sleep duration||Standard Error|Mean
1340010|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Number of Awakenings (NAW)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number||Standard Error|Mean
1340011|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes (min)||Standard Error|Mean
1340012|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Sleep Efficiency (SE)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of time||Standard Error|Mean
1340013|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Sleep Efficiency (PSG SE)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage (%)||Standard Error|Mean
1340014|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Number of Awakenings (PSG NAW)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number of events||Standard Error|Mean
1340015|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes (min)||Standard Error|Mean
1340016|NCT01942720|Secondary|Adverse Events (AE)|To assess safety related to capsule retention and other adverse events|6 months|all enrolled subjects|||AE incidents|||Number
1340017|NCT01942720|Secondary|Evaluate the Entire SB CE Scores|"Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS).~Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific"|6 months change from Baseline|number of Lewis & CECDEIS TI score change is lower due to inability to identify TI. number of participants for this outcome measure includes participants with available data for total SB Lewis score change, TI Lewis score change, Total CECDEIS score change, TI Lewis score change, respectively|||units on a scale||Standard Deviation|Mean
1340018|NCT01942720|Secondary|Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum|Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific cutoff|6 months change from Baseline|number of subjects with Colonoscopy score is lower than number of subjects analyzed due to colonoscopy video malfunction. number of participants for this outcome measure includes participants with available data for TI SES CD, TI Lewis, TI CECDEIS scores, respectively|||units on a scale||Standard Deviation|Mean
1340019|NCT01942720|Secondary|Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes|"Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline.~SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific"|Baseline|number of participants for this outcome measure includes participants with available data for SES CD, TI Lewis score, TI CECDEIS score, respectively|||units on a scale||Standard Deviation|Mean
1346873|NCT01843348|Secondary|Percent of Participants With Viral Infections|Viral infections for BKV Virus Humane Polyomavirus 1 and Cytomegalovirus|Post transplant to month 12|Safety set|||Percent of participants|||Number
1340020|NCT01942720|Primary|Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)|To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no “normal range” Studies discuss a drop in the number as indicating healing but not a specific cutoff|6 months changefrom Baseline|Correlation between changes in VCE mucosal scores (Lewis and CECDEIS) and change in PGA score of CD (Crohn's Disease) activity from baseline to follow-up at 6 months; number of participants for this outcome measure includes participants with available data for PGA, SB (small bowel) Lewis score, SB CECDEIS score, respectively|||units on a scale||Standard Deviation|Mean
1340021|NCT01942707|Secondary|Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.|An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.|Done after 20 days of surgery||||ml||Standard Deviation|Mean
1340022|NCT01942707|Secondary|Number of Days Required for Drain Withdrawal.|Number of days required for drain withdrawal. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.|Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days||||days||Standard Deviation|Mean
1340023|NCT01942707|Primary|Total Volume of Drainage in ml.|We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.|number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days||||ml||Standard Deviation|Mean
1340024|NCT01942590|Secondary|Maximum Expiratory Pressure (MEP)|MEP reflects the strength of the abdominal muscles and other expiratory muscles.|Baseline, Week 18, and Week 52|Participants who completed the MEP testing|||percentage of MEP||Standard Deviation|Mean
1340025|NCT01942590|Secondary|Predicted Maximum Inspiration Pressure (MIP)|MIP is a measurement of inspiratory muscle weakness, including weakness of the diaphragm. MIP is decreased in Pompe disease and reflects weakness of respiratory muscles.|Baseline, Week 18, and Week 52|Participants who completed the MIP testing|||percentage of MIP||Standard Deviation|Mean
1340026|NCT01942590|Secondary|Late-Life Function and Disability Instrument (LLFDI)|The Late-Life Function & Disability Instrument (Late-Life FDI) is an evaluative outcome instrument for community-dwelling older adults. Highest score 240 = normal function and no disability, lowest score 0 = low levels of frequency of participating in life tasks.|Baseline, Week 18, Week 52|Participants who completed LLFDI at the visit. Data was not collected from any participants in the placebo group.|||units on a scale||Standard Deviation|Mean
1340027|NCT01942590|Secondary|Quick Motor Function Test (QMFT)|The QMFT is a criterion referenced assessment designed to measure functional status and change in gross motor function over time and, in particular, to measure clinically relevant change. Consists of 16 motor function tests. Lowest score 0 = unable to perform motor function tests, highest score 64 = normal muscle function.|Baseline, Week 18, and Week 52||||units on a scale||Standard Deviation|Mean
1340028|NCT01942590|Secondary|GSGC (Gait, Stairs, Gowers, Arising From a Chair.)|The GSGC is a criterion referenced assessment designed to measure functional status and change in gross motor function over time and, in particular, to measure clinically relevant change. Consists of 4 components: Gait, Climbing Stairs, Gower’s Manuever, Arising From a Chair. Lowest score 4 = normal muscle function, highest score 27 = unable to perform motor function tests.|Baseline, Week 18, and Week 52|participants who completed GSGC testing|||units on a scale||Standard Deviation|Mean
1340029|NCT01942590|Secondary|Change in Urinary Glc4 Biomarker||Baseline, Week 52|participants who completed urinary Glc4 biomarker collection|||mmol/mol CN||Standard Deviation|Mean
1340030|NCT01942590|Secondary|Change in Urinary Glc4 Biomarker|The Glc4 biomarker is measured in urine and correlates with muscle glycogen content. It is a noninvasive measurement that serves as a biomarker for Pompe disease.|Baseline, Week 18||||mmol/mol CN||Standard Deviation|Mean
1340031|NCT01942590|Secondary|Change in Forced Vital Capacity (FVC) in Pulmonary Function Testing|Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.|Baseline, Week 52|participants who completed FVC testing|||change in FVC measured as % expected||Standard Deviation|Mean
1340032|NCT01942590|Secondary|Change in Forced Vital Capacity (FVC) in Pulmonary Function Testing|Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.|Baseline, Week 18|participants who completed FVC testing|||change in FVC measured as % expected||Standard Deviation|Mean
1340033|NCT01942590|Secondary|Change in 6 Minute Walk Test|Assess exercise tolerance in study patients; test administered by physical therapist. Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters.|Baseline, week 52|Participants who completed 6 minute walk test|||meters||Standard Deviation|Mean
1340034|NCT01942590|Secondary|Change in 6 Minute Walk Test|Assess exercise tolerance in study patients; test administered by physical therapist. Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters.|Baseline, week 18|Participants who completed 6 minute walk test|||meters||Standard Deviation|Mean
1340035|NCT01942590|Primary|Number of Participants With a Change in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Bilirubin Representing Liver Toxicity|Liver toxicity, as defined by a >3x increase in AST or ALT from the respective baseline values and/or an increase in direct, indirect or total bilirubin of >3x the upper limit of normal|Any point up to week 52||||participants|||Number
1340036|NCT01942590|Primary|Number of Participants With a Change in Creatine Kinase (CK) Reflecting Worsening of Muscle Involvement|Worsening muscle involvement, as defined by >3x increase in CK from baseline that is >2x the upper limit of normal|Any point up to week 52||||participants|||Number
1340190|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
1340039|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score|The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|Baseline (Day 1) and Day43||||units on a scale||Standard Error|Mean
1340040|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score|The Positive and Negative Syndrome Scale (PANSS) positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49, with higher values indicating worse condition.|Baseline (Day 1) and Day 43||||units on a scale||Standard Error|Mean
1340041|NCT01942161|Primary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.|Baseline (Day 1) and Day 43||||units on a scale||Standard Error|Mean
1340042|NCT01942148|Secondary|Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)|The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.|Baseline and Week52||||units on a scale||Standard Deviation|Mean
1340043|NCT01942148|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score|The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|Basline and Week52||||units on a scale||Standard Deviation|Mean
1340044|NCT01942148|Primary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.|Basline and Week52||||units on a scale||Standard Deviation|Mean
1340045|NCT01942135|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)|An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.|From the signing of the informed consent until 28 days after the last dose of study medication up to 14 months|The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Percentage of Participants|||Number
1340046|NCT01942135|Secondary|Time to Deterioration (TTD)|A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.|Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment.|||Months||95% Confidence Interval|Median
1340047|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
1340048|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/ impairment Published weights are available that allow for the creation of a single summary score called the EQ-5D index, which basically ranges from 0 to 1 with low scores representing a higher level of dysfunction and 1 as perfect health. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
1340209|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|12 months||||Participants|||Count of Participants
1340049|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from ’not at all’ to ’very much’. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
1340050|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from ’not at all’ to ’very much’. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
1340051|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores|The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from “not at all” to “very much” and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
1340052|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores|The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from “not at all” to “very much” and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
1340053|NCT01942135|Secondary|Ctrough for Goserelin|"Cmin for goserelin (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/ Day 1 and Cycle 3/ Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1340054|NCT01942135|Secondary|Ctrough for Fulvestrant|"Ctrough for Fulvestrant (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/Day 1 and Cycle 3/Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1340055|NCT01942135|Secondary|Observed Plasma Trough Concentration (Ctrough) for Palbociclib|"Ctrough for palbociclib (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycle 1/Day 15 and Cycle 2/Day 15|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1340056|NCT01942135|Secondary|Survival Probabilities at Months 12, 24 and 36|One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.|From randomization until death (assessed up to 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1340075|NCT01941940|Secondary|Percentage of DMARDs Dose Reductions and/or Discontinuation Events by Reasons|Percentage of DMARDs dose reduction and/or discontinuation (Red/Dis) events is reported by different reasons.|Baseline up to Week 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants with DMARDs dose reductions and/or discontinuation.|||percentage of events|DMARDs Dose Red/Dis Events||Number
1340057|NCT01942135|Secondary|Clinical Benefit Response (CBR)|CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.|||percentage of participants||95% Confidence Interval|Number
1340058|NCT01942135|Secondary|Duration of Response (DR)|DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) – first CR or PR date + 1)]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1340059|NCT01942135|Secondary|Objective Response (OR)|OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (OR) = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.|||percentage of participants||95% Confidence Interval|Number
1340060|NCT01942135|Secondary|Overall Survival (OS) - Number of Participants Who Died|OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = [death date (censor date) – randomization date + 1]/30.4. No inferential statistical analysis were done because of the immaturity of the OS data.|From randomization until death (up to approximately 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||deaths|||Number
1340061|NCT01942135|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.|From randomization date to date of first documentation of progression or death (assessed up to 12 months)|The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1340062|NCT01941940|Secondary|Mean Soluble Interleukin-6 Receptor (sIL-6R) Concentration||Baseline, Weeks 12, 24, 38, 52, at early withdrawal (up to Week 52), at Follow-up Visit 2 (Week 76)|FAS; Here 'n' signifies the number of participants evaluable at specified time point.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1340063|NCT01941940|Secondary|Mean Tocilizumab Concentration||Baseline, Weeks 12, 24, 38, 52, at early withdrawal (up to Week 52), at Follow-up Visit 2 (Week 76)|FAS; Here 'n' signifies the number of participants evaluable at specified time point.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1340064|NCT01941940|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Tocilizumab|Percentage of participants with positive results for ATA against tocilizumab at different time points is reported.|Baseline, Weeks 12, 24, 38, 52, at 8 weeks after last dose (up to Week 60), at early withdrawal (up to Week 52), at Follow-up Visits 1 (Week 64), 2 (Week 76), and 3 (Week 88)|FAS; Here, 'n' signifies the number of participants evaluable at specified time point.|||percentage of participants|||Number
1340065|NCT01941940|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) of Special Interest|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are AEs occurring between the first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Following AEs were considered as AEs of special interest: anaphylactic reaction, hypersensitivity, stress cardiomyopathy, Gilbert’s syndrome, gastrointestinal perforation, injection site erythema, injection site hypersensitivity, injection site irritation, injection site pruritus, arthritis bacterial, cellulitis, klebsiella infection, oral candidiasis, pneumonia, skin infection, vulvovaginal candidiasis, alanine aminotransferase increased, hepatic enzyme increased, brain neoplasm malignant, and urticaria.|Baseline up to 95 weeks|FAS|||percentage of participants|||Number
1340066|NCT01941940|Secondary|Treatment Compliance, as Assessed Using Participant Diary Cards and Return Records|Treatment Compliance was calculated as (total actual doses taken for the period) / (total planned or prescribed dose for the period) x 100.|Weeks 24 and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||percentage of planned dose||Standard Deviation|Mean
1340067|NCT01941940|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Weeks 24 and 52|PSQI is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). A participant indicates how frequently each item was experienced on a scale from 0 to 3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality. A score of >/=5 indicates poor sleepers.|Baseline, Weeks 24 and 52|Per-protocol analysis set (PPAS) included all participants in FAS without any major protocol violation and who completed 24 weeks of treatment period. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome; 'n'=participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
1340068|NCT01941940|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Total Score at Weeks 2, 24, and 52|FACIT total score is sum of Functional Assessment of Cancer Therapy-General (FACT-G) score and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; additional concerns) score. FACT-G is a core questionnaire that evaluates quality of life (QoL) in cancer population. FACT-G consists of 27 questions grouped in 4 domains of general health-related QoL: physical well-being, social/family well-being, emotional well-being, and functional well-being; each item ranges from 0 (not at all) to 4 (very much). FACT-G score ranges between 0-108. FACIT-F is a 13-item questionnaire that evaluates self-reported fatigue and its impact upon daily activities. Each item ranges from 0 (Not at all) to 4 (Very much). The sum of all responses result in the FACIT total score with a total possible range of 0 (better score) to 160 (worse score). Negative change from baseline represents a better QoL.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
1340069|NCT01941940|Secondary|Missed Working Days Assessed Using Short Form-Health and Labor Questionnaire (SF-HLQ) Score at Weeks 24 and 52|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consisted of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Weeks 24 and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||days||Standard Deviation|Mean
1340070|NCT01941940|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 24, and 52|HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
1340071|NCT01941940|Secondary|Participant Pain VAS Score at Weeks 2, 24, and 52|Participants assessed their pain using a 0-100 mm VAS. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||mm||Standard Deviation|Mean
1340072|NCT01941940|Secondary|Change From Baseline in PGDA VAS Score at Weeks 2, 24, and 52|The physician assessed participant's current disease activity on a 0-100 mm VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||mm||Standard Deviation|Mean
1340073|NCT01941940|Secondary|Change From Baseline in PtGDA VAS Score at Weeks 2, 24, and 52|"Participants answered the following question: Considering all the ways your arthritis affects you, how are you feeling today. Participants responded by using a 0 - 100 millimeter (mm) VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||mm||Standard Deviation|Mean
1340074|NCT01941940|Secondary|Percentage of Non-DMARDs Dose Reductions and/or Discontinuation Events by Reasons|Percentage of Non-DMARDs dose reduction and/or discontinuation (Red/Dis) events is reported by different reasons.|Baseline up to Week 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants with non-DMARDs dose reductions and/or discontinuation.|||percentage of events|Non-DMARDs Dose Red/Dis Events||Number
1340076|NCT01941940|Secondary|Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|The SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between SDAI and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
1340077|NCT01941940|Secondary|Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between SDAI and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
1340078|NCT01941940|Secondary|Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between CDAI and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
1340079|NCT01941940|Secondary|Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between CDAI and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
1340080|NCT01941940|Secondary|Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between DAS28-ESR and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
1340081|NCT01941940|Secondary|Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between DAS28-ESR and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
1340082|NCT01941940|Secondary|Association Between Disease Activity Parameters: CDAI and SDAI, Assessed Using Correlation Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. Higher scores represent greater affectation due to disease activity. SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. Higher scores indicate greater affectation due to disease activity. Correlation coefficient for relationship between CDAI and SDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||correlation coefficient|||Number
1340083|NCT01941940|Secondary|Association Between Disease Activity Parameters: DAS28-ESR and SDAI, Assessed Using Correlation Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. Higher scores indicate greater affectation due to disease activity. SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. Higher scores indicate greater affectation due to disease activity. Correlation coefficient for relationship between DAS28-ESR and SDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||correlation coefficient|||Number
1340084|NCT01941940|Secondary|Association Between Disease Activity Parameters: DAS28-ESR and CDAI, Assessed Using Correlation Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. Higher scores indicate greater affectation due to disease activity. The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. Higher scores represent greater affectation due to disease activity. Correlation coefficient for relationship between DAS28-ESR and CDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||correlation coefficient|||Number
1340085|NCT01941940|Secondary|Change From Baseline in Total SJC at Weeks 2, 24, and 52|SJC was defined as the total number of swollen joints based on 66-joint assessment (SJC-66) and 28-joint assessment (SJC-28).|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||swollen joints||Standard Deviation|Mean
1340086|NCT01941940|Secondary|Change From Baseline in Total TJC at Weeks 2, 24, and 52|TJC was defined as the total number of painful joints based on 68-joint assessment (TJC-68) and 28-joint assessment (TJC-28).|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||tender joints||Standard Deviation|Mean
1340087|NCT01941940|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 </=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1; non-responders: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||percentage of participants|||Number
1340088|NCT01941940|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|The ACR 20, 50, and 70 responses: greater than or equal to (>/=) 20 percent (%), 50%, and 70% improvement in TJC and SJC (28 assessed joints), and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at each visit.|Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||percentage of participants|||Number
1340089|NCT01941940|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 24, and 52|SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and C-reactive protein (CRP) in milligrams per deciliter (mg/dL). Higher scores indicate greater affectation due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
1340101|NCT01941615|Primary|AUCtau,ss of Levonogestrel|Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
1340090|NCT01941940|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Weeks 2, 24, and 52|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affectation due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR </=3.2 indicates low disease activity, DAS28-ESR >3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR </=3.2 indicates remission.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
1340091|NCT01941940|Secondary|Number of Participants Achieving Clinical Remission According to CDAI up to Week 52|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 during any two consecutive visits, not including the baseline visit indicates disease remission.|Baseline up to Week 52 (Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 38, and 52)|FAS|||participants|||Number
1340092|NCT01941940|Primary|Change From Baseline in CDAI at Week 2|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 2|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1340093|NCT01941940|Primary|Change From Baseline in CDAI at Week 4|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 4|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1340094|NCT01941940|Primary|Change From Baseline in CDAI at Week 8|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 8|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1340095|NCT01941940|Primary|Change From Baseline in CDAI at Week 12|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 12|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1340096|NCT01941940|Primary|Change From Baseline in CDAI at Week 16|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 16|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1340097|NCT01941940|Primary|Change From Baseline in CDAI at Week 20|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 20|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1340098|NCT01941940|Primary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The CDAI is a numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient's global assessment of disease activity (PtGDA) and physician global assessment of disease activity (PGDA) assessed on 0-10 centimeters (cm) visual analogue scale (VAS). Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score less than or equal to (</=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1340099|NCT01941615|Primary|C24,ss of Levonogestrel|Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
1340100|NCT01941615|Primary|Cmax,ss of Levonogestrel|Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
1340102|NCT01941615|Primary|C24,ss of Ethinylestradiol|Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
1340103|NCT01941615|Primary|Cmax,ss of Ethinylestradiol|Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
1340104|NCT01941615|Primary|AUCtau,ss of Ethinylestradiol|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
1340105|NCT01941498|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature was assessed by a commercially available system and measured in diopters.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||diopter||Standard Deviation|Mean
1340106|NCT01941498|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Baseline (Day 0), Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.|||microns||Standard Deviation|Mean
1340107|NCT01941498|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity.|Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|"This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. Here, n is the number of subjects assessed uncorrected."|||logCS||Standard Deviation|Mean
1340108|NCT01941498|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
1340109|NCT01941498|Secondary|"Percent Response by Category: My Vision Is a Concern in My Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
1340110|NCT01941498|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
1340111|NCT01941498|Secondary|"Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore..."|As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
1340112|NCT01941498|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||units on a scale||Standard Deviation|Mean
1340113|NCT01941498|Secondary|Mean Total Laser Treatment Time|Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.|||seconds||Standard Deviation|Mean
1340114|NCT01941498|Secondary|Mean Laser Treatment Time|Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.|||seconds||Standard Deviation|Mean
1340139|NCT01941485|Secondary|Incidence of Development of Opaque Bubble Layer (OBL)|OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of participants|||Number
1340115|NCT01941498|Secondary|Mean Manifest Refraction (Cylinder)|Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||diopter|Participants|Standard Deviation|Mean
1340116|NCT01941498|Secondary|Mean Manifest Refraction (Sphere)|Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||diopter|Participants|Standard Deviation|Mean
1340117|NCT01941498|Secondary|Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||microns||Standard Deviation|Mean
1340118|NCT01941498|Primary|Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA|Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.|Month 1|This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.|||logMAR||Standard Error|Least Squares Mean
1340119|NCT01941485|Secondary|Corneal Topography: Angles|The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||degrees|Eyes|Standard Deviation|Mean
1340120|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Depth|The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||millimeters|Eyes|Standard Deviation|Mean
1340121|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Volume|The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||millimeters cubed|Eyes|Standard Deviation|Mean
1340122|NCT01941485|Secondary|Corneal Topography: Q-value|The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (−1 < Q < 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q > 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||unit less|Eyes|Standard Deviation|Mean
1340123|NCT01941485|Secondary|Flap Creation Time as Documented in the Log Files|The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||seconds||Standard Deviation|Mean
1340124|NCT01941485|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature as assessed by a commercially available system and measured in diopters.|Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||diopter||Standard Deviation|Mean
1340125|NCT01941485|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
1340126|NCT01941485|Secondary|"Percent Response by Category: My Vision is a Concern in my Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of subjects|||Number
1340127|NCT01941485|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of subjects|||Number
1340128|NCT01941485|Secondary|"Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.|||percentage of subjects|||Number
1340129|NCT01941485|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||units on a scale||Standard Deviation|Mean
1340130|NCT01941485|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||micrometers||Standard Deviation|Mean
1340131|NCT01941485|Secondary|Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)|The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.|Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||millimeters||Standard Deviation|Mean
1340132|NCT01941485|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. Both eyes contributed to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||logCS||Standard Deviation|Mean
1340133|NCT01941485|Secondary|Manifest Refraction (Cylinder)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||Diopters|eyes|Standard Deviation|Mean
1340134|NCT01941485|Secondary|Manifest Refraction (Sphere)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||Diopters|Eyes|Standard Deviation|Mean
1340135|NCT01941485|Secondary|Best Corrected Visual Acuity (BCVA)|VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||logMAR||Standard Deviation|Mean
1340136|NCT01941485|Secondary|Uncorrected Visual Acuity (UCVA)|Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||logMAR||Standard Deviation|Mean
1340137|NCT01941485|Secondary|The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively|The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Month 1 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||microns||Standard Deviation|Mean
1340138|NCT01941485|Secondary|Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap|The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of flap||Standard Deviation|Mean
1340241|NCT01940120|Secondary|Cardiac Output|CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Cardiac output evaluation was not done or un-evaluable.|||l/min||Standard Deviation|Mean
1340140|NCT01941485|Primary|The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Day 1 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||microns||Standard Deviation|Mean
1340141|NCT01941472|Primary|Fluid Responsiveness|Increase in cardiac index ≥ 10% after fluid challenge|Immediately after fluid challenge, average 5 minutes||||Participants|||Count of Participants
1340142|NCT01941186|Other Pre-specified|Acceptability of the Patient Decision Aid for Early Intervention Referral|The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.|Up to 7 days|"Provider information was not collected as outlined in the initial protocol design. All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. This includes elements of parent acceptability. A separate analysis was not completed."||||||
1340143|NCT01941186|Other Pre-specified|Feasibility of the Patient Decision Aid|The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.|Up to 7 days|Data was not collected regarding the time to complete PDA and/or number of Early Intervention referrals for the total population, thus data for this outcome measure was not able to be analyzed as outlined at the time of protocol development.||||||
1340144|NCT01941186|Other Pre-specified|Parental Predisposition for Early Intervention|Parental predisposition for early intervention services will be measured using surveys.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."||||||
1340145|NCT01941186|Other Pre-specified|Parent Uncertainty About Early Intervention|Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."||||||
1340146|NCT01941186|Secondary|Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention|Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.|Up to 7 days|All parent-child dyads who were enrolled and randomized were included in the analysis.|||percentage of participants|||Number
1340147|NCT01941186|Primary|Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups|Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.|Up to 1 year after randomization|One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation.|||participants|||Number
1340148|NCT01940900|Primary|Mean Change in Visual Acuity From Baseline to 12 Months|The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.|12 Months|Mean change in visual acuity (ETDRS letter) from Baseline to Month 12|||letters||Standard Error|Mean
1340149|NCT01940523|Secondary|Units of Transfusion|The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay.|over course of hospital stay (averaging three days)|||||||
1340150|NCT01940523|Secondary|Drain Output|The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.|from end of surgery to 24 hours postoperatively||||ml||Standard Deviation|Mean
1340151|NCT01940523|Primary|Total Blood Loss|The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.|during surgery||||ml||Standard Deviation|Mean
1340152|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||nmol/L||Standard Deviation|Mean
1340153|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the molar plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||nmol*hour/L||Standard Deviation|Mean
1340177|NCT01940484|Secondary|Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta|Dose adjustment included dose increase or dose decrease with respect to previous visit’s dose.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)|Included all enrolled participants who were evaluable for this outcome measure.|||participants|||Number
1340154|NCT01940510|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||liters||Standard Deviation|Mean
1340155|NCT01940510|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||liters/hour||Standard Deviation|Mean
1340156|NCT01940510|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||hours||Standard Deviation|Mean
1340157|NCT01940510|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib and RO5468924|The Tmax is the time from alectinib administration to reach Cmax for alectinib and RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||hours||Full Range|Median
1340158|NCT01940510|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib and RO5468924|AUC(0-last) is the area under the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) plasma concentration time-curve from time zero to the last measured concentration. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
1340159|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ratio||Standard Deviation|Geometric Mean
1340160|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ratio||Standard Deviation|Geometric Mean
1340161|NCT01940510|Secondary|Cmax of RO5468924|Cmax is the maximum observed RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration, presented in ng/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng/mL||Standard Deviation|Mean
1340162|NCT01940510|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
1340163|NCT01940510|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed alectinib plasma concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng/mL||Standard Deviation|Mean
1340164|NCT01940510|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|The Pharmacokinetic (PK) analysis set included all participants who received both scheduled doses of alectinib (on Day 1 and Day 17), and provided adequate PK assessments.|||ng*hour/mL||Standard Deviation|Mean
1340165|NCT01940497|Secondary|Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)|Percentage of HCPs providing responses to various questions related to overall ease of study drug administration was reported in different categories, where categories indicate all possible responses to such questions.|After at least 4 participants completed 5 cycles of adjuvant treatment (1 cycle = 21 days; maximum up to 1 year)|HCPQ population included all investigators and study nurses who completed the questionnaire at each site when at least 4 participants from their site had received at least 5 cycles of adjuvant study treatment (52 and 50, respectively for Vial and SID groups).|||percentage of health care professionals|||Number
1340178|NCT01940484|Secondary|Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study||Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)|"Included all enrolled participants who were evaluable for this outcome measure and n represents number of participants evaluable at the specified time point."|||mcg||Standard Deviation|Mean
1340179|NCT01940484|Primary|Mean Hemoglobin Value at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
1340180|NCT01940484|Primary|Mean Hemoglobin Value at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
1340166|NCT01940497|Secondary|Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)|Participants were asked the following 5 questions: (1) “Following the first injection given by the physician/nurse and training on how to use the SID, I felt comfortable injecting the study drug by myself”; (2) “The SID was convenient and easy to use”; (3) “I am confident giving myself an injection in the thigh with the SID”; (4) “Taking all things into account, I find self-administration using the SID satisfactory”; (5) “If given the opportunity, I would choose to continue self-injecting the study drug using the SID at home”. Response to each question was recorded as either of the following options: “Unknown”, “Strongly Disagree”, “Disagree”, “Unsure”, “Agree”, “Strongly Agree”. Percentage of participants who provided responses to above questions was reported. Data for this outcome measure were analyzed and reported only for Trastuzumab (SID) arm.|After at least 14 cycles (1 cycle = 21 days; maximum up to 1 year)|PSQ population included all enrolled participants from trastuzumab (SID) group who were able to use SID and had completed a minimum of 14 administrations of trastuzumab subcutaneously using SID (at least 10 of which were self-administered). Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1340167|NCT01940497|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first treatment to death from any cause. Kaplan-Meier estimates were used for analysis. Participants who did not die were censored on the date they were last known to be alive. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to death due to any cause (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population|||months||95% Confidence Interval|Median
1340168|NCT01940497|Secondary|Percentage of Participants Who Died|Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to death due to any cause (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population|||percentage of participants|||Number
1340169|NCT01940497|Secondary|Disease-Free Survival (DFS) Using Mammography|DFS was defined as the time from the first treatment to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Kaplan-Meier estimates were used for analysis. Participants who were disease-free were censored at the data cut off date. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first) (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population. Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1340170|NCT01940497|Secondary|Percentage of Participants With Event (Local, Regional or Distant Recurrence, Contralateral Breast Cancer or Death) Using Mammography|A participant was considered as disease free if the participant was free from local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Percentage of participants with event at the cut off date were reported. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first) (assessed up to cut off date 05 April 2016; up to approximately 2.5 years)|m-ITT population. Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1340171|NCT01940497|Secondary|Percentage of Participants With Pathological Complete Response (pCR) (Neoadjuvant Groups Only) Using Mammography|In the neoadjuvant setting, the activity of two sequential drug regimens, doxorubicin-containing chemotherapy followed by paclitaxel or docetaxel chemotherapy in combination with trastuzumab, was assessed as the percentage of participants with pCR in breast and nodes using mammography. pCR was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after preoperative treatment. Data for this outcome measure were analyzed and reported only for neoadjuvant groups within each treatment arm.|Day 1 up to 24 weeks|Modified intent-to-treat (m-ITT) population included all enrolled participants satisfying criteria for eligibility.|||percentage of participants||95% Confidence Interval|Number
1340172|NCT01940497|Secondary|Percentage of Participants Who Received Concomitant Medications||Screening (Day -28 to -1) up to 2.5 years (assessed up to cut off date 05 April 2016)|Safety population|||percentage of participants|||Number
1340173|NCT01940497|Secondary|Duration of Treatment With Trastuzumab|Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up last dose of trastuzumab (assessed up to cut off date 05 April 2016; up to approximately 1 year)|Safety population|||days||Standard Deviation|Mean
1340174|NCT01940497|Secondary|Actual Dose of Trastuzumab Administered|Actual dose (mg) administered = (sum over all cycles of actual dose received [mg] divided by number of cycles). Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up last dose of trastuzumab (assessed up to cut off date 05 April 2016; up to approximately 1 year)|Safety population|||mg||Standard Deviation|Mean
1340175|NCT01940497|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to 28 days after last dose of trastuzumab (assessed up to cut off date 05 April 2016; up to approximately 1 year)|Safety population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
1340176|NCT01940484|Secondary|Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert|Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.|Up to 6 months|Due to observational nature of the study, the data for this outcome measure could not be collected.||||||
1340191|NCT01940471|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1340192|NCT01940471|Secondary|Change From Baseline at Week 48 in Serum Creatinine||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||mg/dL||Standard Deviation|Mean
1340193|NCT01940471|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percentage change||Standard Deviation|Mean
1340194|NCT01940471|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percentage change||Standard Deviation|Mean
1340195|NCT01940471|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48||Week 48|Serologically Evaluable Full Analysis Set: participants who were randomized, had received at least 1 dose of study drug, and were HBeAg positive and anti-HBe negative or had a value missing value at baseline. Participants were analyzed according to their randomized treatment group. All missing data were treated as no HBeAg seroconversion.|||percentage of participants|||Number
1340196|NCT01940471|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL||Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
1340197|NCT01940354|Secondary|Clinician Satisfaction Upon Successful PIV Placement|"Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: “How easy was the AccuCath™ System to use in comparison to the current catheter? 5 – Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 – Somewhat Difficult to Use~1 - Very Difficult to Use"|Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes|The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 5 in Study Device arm and n = 1 in the Control Arm).|||units on a scale||Standard Deviation|Mean
1340198|NCT01940354|Secondary|Patient Satisfaction Upon Successful PIV Placement|Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 – Very Comfortable, 4 – Somewhat Comfortable, 3 – Neutral, 2– Somewhat Uncomfortable, 1 – Very Uncomfortable|Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes|The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 6 in Study Device arm and n = 1 in the Control Arm).|||units on a scale||Standard Deviation|Mean
1340199|NCT01940354|Primary|First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement||Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes||||Participants|||Count of Participants
1340200|NCT01940341|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1340201|NCT01940341|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.|||mg/dL||Standard Deviation|Mean
1340202|NCT01940341|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.|||percentage change||Standard Deviation|Mean
1340203|NCT01940341|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percentage change||Standard Deviation|Mean
1340204|NCT01940341|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL|The primary efficacy endpoint was determined by the achievement of HBV DNA < 29 IU/mL at Week 48.|Week 48|Full Analysis set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||Percentage of participants|||Number
1340205|NCT01940146|Primary|Change in Total Nasal Symptom Score From Baseline to Day 14.|The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.|Baseline to Day 14||||units on a scale||Standard Error|Least Squares Mean
1340206|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|48 months||||Participants|||Count of Participants
1340207|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|36 months||||Participants|||Count of Participants
1340208|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|24 months||||Participants|||Count of Participants
1340210|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
1340211|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
1340212|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
1340213|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
1340214|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
1340215|NCT01940120|Secondary|Number of Participants With Second MitraClip Device Implanted|It is a summary of re-interventions to place an additional MitraClip Device.|0 to 5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340216|NCT01940120|Secondary|Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure|Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340217|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|60 months|Patients implanted with a MitraClip device and alive were evaluated at 60 months.|||Participants|||Count of Participants
1340218|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|36 months|Patients implanted with a MitraClip device, alive were evaluated at 36 months.|||Participants|||Count of Participants
1340219|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|48 months|Patients implanted with a MitraClip device and alive were evaluated at 48 months.|||Participants|||Count of Participants
1340220|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|24 months|Patients implanted with a MitraClip device, alive were evaluated at 24 months.|||Participants|||Count of Participants
1340221|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|0 to 12 months|Three patients were excluded from the analysis as they did not receive a Device.|||Participants|||Count of Participants
1340222|NCT01940120|Secondary|Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+|Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.|24 months|Primary Analysis at 24 months included only 75 patients. Three patients were excluded due to withdrawal at or before 12 months.|||percentage of participants||95% Confidence Interval|Number
1340242|NCT01940120|Secondary|Cardiac Output|CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac output evaluation was not done or un-evaluable.|||l/min||Standard Deviation|Mean
1341871|NCT01923480|Secondary|Plasma Concentration of Aspartic Acid||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1340223|NCT01940120|Secondary|Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death|"Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction.~Cardiac perforation/pericardial tamponade.~Arrhythmia or conduction abnormality.~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|24 months|Analysis population includes 46 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 24 months.|||percentage of participants|||Number
1340224|NCT01940120|Secondary|Number of Participants With Mitral Valve Repair Success|Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.|24 months|Three Acute Procedural Success (APS) patients withdrew at or before 12 months, and had MR ≤ 2+ at all visits prior to withdrawal. Since there is no data on these patients post-12 months, these patients are not included in the endpoint of freedom from mitral valve replacement surgery for Valve Dysfunction, death and MR > 2+ at 24 months.|||Participants|||Count of Participants
1340225|NCT01940120|Secondary|Number of Participants With Mitral Valve Repair Success|Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR > 2+ at 12 months.|12 months||||Participants|||Count of Participants
1340226|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|60 months|Analysis population includes 14 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 60 months.|||percentage of participants|||Number
1340227|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|48 months|Analysis population includes 35 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 48 months.|||percentage of participants|||Number
1340228|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|36 months|Analysis population includes 39 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.|||percentage of participants|||Number
1340229|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|24 months|Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.|||percentage of participants|||Number
1340230|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from Mitral valve (MV)surgery analysis at 12 months.|||percentage of participants|||Number
1340231|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|Baseline||||percentage of participants|||Number
1340232|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340233|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340234|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340235|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340236|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340237|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|Discharge or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340238|NCT01940120|Secondary|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients cardiac index evaluation was not done or un-evaluable.|||l/min/m2||Standard Deviation|Mean
1340239|NCT01940120|Secondary|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac Index evaluation was not done or un-evaluable.|||l/min/m2||Standard Deviation|Mean
1340240|NCT01940120|Secondary|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|30 Days|Of 78 total population, 66 participants were included in the analysis population because of 6 deaths within 30 days and in 6 participants cardiac Index was un-evaluable or not done.|||l/min/m2||Standard Deviation|Mean
1340243|NCT01940120|Secondary|Cardiac Output (CO)|CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).|30 Days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths within 30 days and in 6 patients Cardiac Output was not assessed or or un-evaluable.|||l/min||Standard Deviation|Mean
1340244|NCT01940120|Secondary|Regurgitant Fraction|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant fraction assessment.|||percentage of LV stroke volume||Standard Deviation|Mean
1340245|NCT01940120|Secondary|Regurgitant Fraction|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant fraction evaluation was not done or not evaluable.|||percentage of LV stroke volume||Standard Deviation|Mean
1340246|NCT01940120|Secondary|Regurgitant Fraction (RF)|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|30 days|Of 78 total population, 58 participants were analysed as 6 participants died within 30 days and 14 missing data (not done or not evaluable).|||percentage of LV stroke volume||Standard Deviation|Mean
1340247|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant Volume assessment.|||mL||Standard Deviation|Mean
1340248|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant volume evaluation was not done or not evaluable.|||mL||Standard Deviation|Mean
1340249|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|30 days|Of 78 total population, 58 participants were included in the analysis population because of 6 deaths within 30 days and 14 missing data (not done or not evaluable).|||mL||Standard Deviation|Mean
1340250|NCT01940120|Secondary|Number of Hospital Re-Admissions for Congestive Heart Failure (CHF)|Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.|12 months|Of 78 patients, 3 patients who died prior to discharge were not included.|||Events|||Number
1340251|NCT01940120|Secondary|Number of Days Re-hospitalized for CHF|Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.|12 months|12/75 hospitalized for CHF post-discharge, representing 22 separate hospitalization events with mean of 6.6+/-3.7 days.|||days||Standard Deviation|Mean
1340252|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340253|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340254|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340255|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and LVIDd/LVIDs not done or un-evaluable in 2 patients.|||cm||Standard Deviation|Mean
1340256|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1340257|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1340258|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1340259|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 5 patients.|||mL||Standard Deviation|Mean
1340260|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1340261|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1340262|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
1340263|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 5 patients.|||mL||Standard Deviation|Mean
1340264|NCT01940120|Secondary|Number of Participants With New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340265|NCT01940120|Secondary|Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|48 months|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and NYHA was not assessed in 3 patients.|||Participants|||Count of Participants
1340266|NCT01940120|Secondary|Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 months|Of 78 total population, 37 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.|||Participants|||Count of Participants
1340267|NCT01940120|Secondary|Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|Of 78 total population, 43 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 1 patient without NYHA Class assessment.|||Participants|||Count of Participants
1340268|NCT01940120|Secondary|Number of Participants With Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|24 months|Through 24 months, the clinical durability status of 3 patients is unknown and there were 35 patients with an acute reduction in MR severity from baseline of at least one grade (the one patient who underwent surgery between 12 months and 24 months is not included in the 35 patients).|||Participants|||Count of Participants
1340269|NCT01940120|Secondary|Number of Participants With Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|12 months|There were 62 patients with an acute reduction in MR severity of at least one grade, and of these, 43 patients met the criterion for clinical durability. The clinical durability rate is therefore 43/62, or 69.4%.|||Participants|||Count of Participants
1340270|NCT01940120|Secondary|Number of Participants With Treatment Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|24 months|At 24 months, of the 56 patients who achieved acute procedural success, the status of 3 patients is unknown. Among the remaining 53 patients, 30 patients (56.6%) were alive and free from MR > 2+ at 24 months.|||Participants|||Count of Participants
1340271|NCT01940120|Secondary|Number of Participants With Treatment Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|12 months|Of 78 total population, 56 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals and 1 missed visit.|||Participants|||Count of Participants
1340272|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340273|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|48 months|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and MR severity was not done or un-evaluable in 3 patients.|||Participants|||Count of Participants
1340274|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|36 months|Of 78 total population, 37 participants were included in the analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and MR Severity was not done or un-evaluable in 2 patients.|||Participants|||Count of Participants
1340275|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and MR severity not assessed in 2 patients.|||Participants|||Count of Participants
1340276|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and MR Severity not done or un-evaluable in 2 patients.|||Participants|||Count of Participants
1340277|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|Discharge or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340278|NCT01940120|Secondary|Number of Participants With High Risk Procedural Success|Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.|30 days||||Participants|||Count of Participants
1340279|NCT01940120|Secondary|Number of Participants With Successful Clip Implant|Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.|30 Days||||Participants|||Count of Participants
1340280|NCT01940120|Secondary|Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time|Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.|Length of ICU/CCU stay, assessed at 30 Days||||hours||Standard Deviation|Mean
1340281|NCT01940120|Secondary|Post-procedure Length of Hospital Stay|Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.|Length of Hospital Stay, assessed at 30 days||||days||Standard Deviation|Mean
1340282|NCT01940120|Secondary|Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital|Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.|30 Days||||Participants|||Count of Participants
1340283|NCT01940120|Secondary|Number of Participants With New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|12 months|49 patients not on coumadin at baseline are included in the analysis.|||Participants|||Count of Participants
1340284|NCT01940120|Secondary|Number of Participants With New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|6 months|49 patients not on coumadin at baseline are included in the analysis.|||Participants|||Count of Participants
1340285|NCT01940120|Secondary|Number of Participants With New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|30 days|49 patients not on coumadin at baseline are included in the analysis.|||Participants|||Count of Participants
1340695|NCT01935947|Other Pre-specified|Predictive and Prognostic Value of the Previously Defined Epigenetic Signature, Comprised of Promoter Methylation Analysis of 4 Target Genes||After 1 month of therapy|Data was not collected to assess this outcome measure due to early study termination.||||||
1340286|NCT01940120|Secondary|Mitral Valve Index|Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve index evaluation was not done or un-evaluable.|||cm^2/m^2||Standard Deviation|Mean
1340287|NCT01940120|Secondary|Mitral Valve Index|Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]|30 days|Of 78 total population, 50 participants were included in the analysis population because of 6 deaths within 30 days and in 22 participants Mitral valve index was not done or un-evaluable.|||cm^2/m^2||Standard Deviation|Mean
1340288|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
1340289|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|48 months|Of 78 total population, 31 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 8 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
1340290|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|36 months|Of 78 total population, 36 participants were included in analysis population because of 31 deaths within 2 years, 7 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
1340291|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
1340292|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
1340293|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|30 days|Of 78 total population, 69 participants were included in the analysis population because of 6 deaths within 30 days and in 3 participants Mitral Valve Gradient was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
1340294|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1340295|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1340296|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1340297|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 40 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Area evaluation was not done or un-evaluable|||cm^2/m^2||Standard Deviation|Mean
1340298|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Area evaluation was not done or un-evaluable|||cm^2/m^2||Standard Deviation|Mean
1340299|NCT01940120|Secondary|Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula|"Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).~[MVA Index = MVA (cm^2)/BSA (m^2)]"|30 days|Of 78 total population, 65 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by pressure half-time was not done in 7 patients.|||cm^2/m^2||Standard Deviation|Mean
1340300|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1340301|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1340302|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
1340696|NCT01935947|Other Pre-specified|Genome-wide Techniques, Including Expression Array and Methylation Array|Expression array and methylation array will be compared to response.|After 1 month of therapy|Data was not collected to assess this outcome measure due to early study termination.||||||
1340303|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral Valve Area evaluation was not done or un-evaluable|||cm^2/m^2||Standard Deviation|Mean
1340304|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral Valve Area evaluation was not done or un-evaluable.|||cm^2/m^2||Standard Deviation|Mean
1340305|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by planimetry was not done in 22 patients.|||cm^2/m^2||Standard Deviation|Mean
1340306|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1340307|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1340308|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1340309|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
1340310|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
1340311|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths and in 6 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
1340312|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
1340313|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|48 months|Of 78 total population, 18 participants were included in analysis population because of 33 deaths within 4 years, 8 withdrawals, 3 missed visit and in 16 patients Mitral Valve Area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
1340314|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|36 months|Of 78 total population, 25 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 14 patients mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
1340315|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
1340316|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
1340317|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.|||cm^2||Standard Deviation|Mean
1340318|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|48 months||||Participants|||Count of Participants
1340319|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|36 months||||Participants|||Count of Participants
1340320|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|24 months||||Participants|||Count of Participants
1340321|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|12 months|Of total 78 participants, only 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.|||Participants|||Count of Participants
1340322|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|30 days|Of total 78 participants, only 72 participants were analyzed as 6 deaths within 30 days.|||Participants|||Count of Participants
1340323|NCT01940120|Secondary|Number of Participants With Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|12 months||||Participants|||Count of Participants
1340324|NCT01940120|Secondary|Number of Participants With Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|30 days||||Participants|||Count of Participants
1340325|NCT01940120|Secondary|Number of Participants With Endocarditis|"Using Duke Criteria, endocarditis can be confirmed by:~Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.~Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.~Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.~Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria."|12 months||||Participants|||Count of Participants
1340326|NCT01940120|Secondary|Number of Participants With Endocarditis|"Using Duke Criteria, endocarditis can be confirmed by:~Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.~Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria."|30 days||||Participants|||Count of Participants
1340327|NCT01940120|Secondary|Number of Participants With Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|12 months||||Participants|||Count of Participants
1340328|NCT01940120|Secondary|Number of Participants With Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|30 days||||Participants|||Count of Participants
1340329|NCT01940120|Secondary|Number of Participants With Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.|12 months||||Participants|||Count of Participants
1340330|NCT01940120|Secondary|Number of Participants With Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms|30 days||||Participants|||Count of Participants
1340331|NCT01940120|Secondary|Number of Participants With Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|12 months||||Participants|||Count of Participants
1340332|NCT01940120|Secondary|Number of Participants With Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|30 days||||Participants|||Count of Participants
1340333|NCT01940120|Secondary|Number of Participants With Non-cerebral Thromboembolism|Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.|12 months||||Participants|||Count of Participants
1340334|NCT01940120|Secondary|Number of Participants With Non-cerebral Thromboembolism|Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.|30 days||||Participants|||Count of Participants
1340335|NCT01940120|Secondary|Number of Participants With Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|12 months||||Participants|||Count of Participants
1340336|NCT01940120|Secondary|Number of Participants With Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|30 days||||Participants|||Count of Participants
1340337|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arterial-venous fistula;~Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;~Vascular surgical repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|12 months||||Participants|||Count of Participants
1340338|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arterial-venous fistula;~Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;~Vascular surgical repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|30 days||||Participants|||Count of Participants
1340339|NCT01940120|Secondary|Number of Participants Over 75 Years of Age With MAE|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months|Analysis population includes 48 patients who were aged 75 years or older in the study.|||Participants|||Count of Participants
1340473|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||percentage of participants|||Number
1340340|NCT01940120|Secondary|Number of Participants Over 75 Years of Age With MAE|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|Analysis population includes 48 patients who were aged 75 years or older in the study.|||Participants|||Count of Participants
1340341|NCT01940120|Secondary|Procedural Freedom From In-hospital MAE|Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.|30 Days||||participants|||Number
1340342|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months||||Participants|||Count of Participants
1340343|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events (MAE)|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days||||Participants|||Count of Participants
1340344|NCT01940120|Primary|Left Ventricular (LV) Function - Internal Dimension|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|Discharge or 30 days||||cm||Standard Deviation|Mean
1340345|NCT01940120|Primary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|Discharge or 30 days||||ml||Standard Deviation|Mean
1340346|NCT01940120|Primary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|Discharge or 30 days||||ml||Standard Deviation|Mean
1340347|NCT01940120|Primary|Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months|Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.|||Participants|||Count of Participants
1340348|NCT01940120|Primary|Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months|Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.|||Participants|||Count of Participants
1340349|NCT01940120|Primary|Left Ventricular (LV) Function - Internal Dimension|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.|||cm||Standard Deviation|Mean
1340350|NCT01940120|Primary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 2 patients.|||ml||Standard Deviation|Mean
1340351|NCT01940120|Primary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 2 patients.|||ml||Standard Deviation|Mean
1340352|NCT01940120|Primary|Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36|Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||score on a scale||Standard Deviation|Mean
1340353|NCT01940120|Primary|Number of Participants With New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.|||Participants|||Count of Participants
1341872|NCT01923480|Secondary|Plasma Concentration of Arginine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1340354|NCT01940120|Primary|Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.|||Participants|||Count of Participants
1340355|NCT01940120|Primary|Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+|Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less|12 months||||percentage of participants|||Number
1340356|NCT01940120|Primary|Composite Functional and Structural Measures - Freedom From Death|"Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction.~Cardiac perforation/pericardial tamponade.~Arrhythmia or conduction abnormality.~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|12 months||||Participants|||Count of Participants
1340357|NCT01939938|Secondary|MRI of Upper Airway With Opposite PAP Mask|MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type.|Approximately 1 hour||||Participants|||Count of Participants
1340358|NCT01939938|Primary|AHI|The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.|through study completion, an average of 1 hour||||events per hour||Standard Deviation|Mean
1340359|NCT01939548|Secondary|Concentration of PF-02545920 and Its Metabolite, PF-01001252|Pharmacokinetic (PK) samples were collected at varying times relative to drug dosing whenever participants could be scheduled for study visits (sparse PK sampling). Thus, because of the variable time between the last dose and the collection of the PK samples, typical summary PK analyses were not planned or described in the study protocol and are not available. The study protocol analysis section specified that the sparse sampled PK data might be pooled with PK data from previous PF-02545920 clinical studies, however the study results did not support conducting those analyses.|Days 14, 28, 42, 56, 70, 84/Early Termination|Summary PK analyses were not planned or performed due to sparse PK sampling.||||||
1340360|NCT01939548|Secondary|Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS assessed whether participant experienced the following: completed suicide (Category 1), suicide attempt (Category 2; response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Category 3; “Yes” on “preparatory acts or behavior”), suicidal ideation (Category 4; “Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (Category 7; “Yes” on “Has subject engaged in non-suicidal self-injurious behavior”).|Baseline up to 7-10 days after last dose of study drug|All participants who had received at least 1 dose of study drug.|||participants|||Number
1340361|NCT01939548|Secondary|Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period|The MDBS-D quantified the dystonia burden during the active treatment period. For an individual participant, MDBS-D took into account all treatment-emergent dystonia events and was defined as a combination of the severity of the AE due to dystonia, AE duration, prescribed concomitant medication, and the total number of days the study treatment was received. Scores for the MDBS-D ranged from 0 (no dystonia events) to 4.5, with higher scores indicating greater dystonia burden.|Active treatment period (Weeks 1 to 12/Early Termination)|All participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1340362|NCT01939548|Secondary|Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale‑Abbreviated (ESRS‑A)|The ESRS-A is a 28-item instrument designed to facilitate standardized observations of parkinsonism, dystonia, dyskinesia, and akathisia. Ratings were determined through a combination of clinical interview and a motor examination. Scores were divided into individual domain scores and clinical global impression scores (CGI-S). Scores started from 0 (normal) to 6 (0 to 8 for CGI-S), with higher scores indicating greater severity.|Baseline, Week 12|All participants who received at least 1 dose of study drug. n=number of evaluable participants for each parameter at the specified time points.|||units on a scale||Standard Deviation|Mean
1340363|NCT01939548|Secondary|Change From Baseline in Prolactin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||nanogram (ng)/milliliter||Standard Deviation|Mean
1340364|NCT01939548|Secondary|Change From Baseline in Insulin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||micro international unit/milliliter||Standard Deviation|Mean
1340697|NCT01935947|Secondary|Progression Free Survival|From the time of randomization until radiologic or clinical progression is noted, assessed up to 2 years.|up to 2 years|Data was not collected to assess this outcome measure due to early study termination.||||||
1340365|NCT01939548|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||percent||Standard Deviation|Mean
1340366|NCT01939548|Secondary|Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12|Choleseterol, TG, glycosylated hemoglobin (HbA1c), LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
1340367|NCT01939548|Secondary|Number of Participants With Extrapyramidal Motor System (EPS) AEs|EPS AEs consisted of oromandibular dystonia, extrapyramidal disorder, akathisia, dyskinesia, and tremor.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.|||participants|||Number
1340368|NCT01939548|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, lipids, electrolytes, hormones (prolactin), clinical chemistry, and urinalysis (dipstick and microscopy).|Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only)|All participants who had received at least 1 dose of study drug and who were evaluable for laboratory abnormalities.|||participants|||Number
1340369|NCT01939548|Secondary|Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.|Baseline and Week 12 or Early Termination|All participants who received at least 1 dose of study drug and who were evaluable for physical examinations.|||participants|||Number
1340370|NCT01939548|Secondary|Number of Participants With Weight Change >=7%|The effects of PF-02545920 on body weight were evaluated. The number of participants with changes from baseline in body weight of >=7% were tabulated and summarized.|Screening up to Day 84|All participants who received at least 1 dose of study treatment.|||participants|||Number
1340371|NCT01939548|Secondary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec.|Screening/Baseline up to Week 12 (or Early Termination)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified ECG parameter.|||participants|||Number
1340372|NCT01939548|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate of <40 or more than (>)120 beats per minute (bpm); and standing pulse rate of <40 or >140 bpm.|Screening up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified vital sign parameter.|||participants|||Number
1340373|NCT01939548|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.|||participants|||Number
1340374|NCT01939548|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12|CGI-I: 7-point clinician-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Participants in the FAS who were evaluable for this outcome measure at Week 12.|||units on a scale||Standard Deviation|Mean
1340375|NCT01939548|Secondary|Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician-rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. n=number of evaluable participants in the FAS at the specified time point.|||units on a scale||Standard Deviation|Mean
1340386|NCT01939496|Secondary|Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340376|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores|The subscales based on Marder factors are: negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 7 to 49 for negative symptoms, 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for uncontrolled hostility/excitement and anxiety/depression. Higher scores indicate higher severity of symptoms.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.|||units on a scale||Standard Deviation|Mean
1340377|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales|The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.|||units on a scale||Standard Deviation|Mean
1340378|NCT01939548|Secondary|Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score|The Personal and Social Performance Scale (PSP) is a validated clinician-related scale that measured personal and social functioning in the domains of: socially useful activities (eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviors. Information from the participant and the informant were utilized in determining the rating. A PSP total score was determined from the 4 domains (score range 0-100). A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a participant with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. The number of evaluable participants at Week 12 were those in the FAS with available data at Week 12 (n=number of evaluable participants at the specified time point)|||units on a scale||Standard Deviation|Mean
1340379|NCT01939548|Primary|Change From Baseline to Week 12 in PANSS Total Score|The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Week 12|All participants in the Full Analysis Set (FAS, defined as all participants who received at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline measurement) who had available data for this outcome measure at Week 12.|||units on a scale||Standard Deviation|Mean
1340380|NCT01939548|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline|The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|All participants who received study treatment.|||units on a scale||Standard Deviation|Mean
1340381|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6|The difference in seated heart rate and standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||beats per minute||Standard Deviation|Mean
1340382|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6|The difference in seated office blood pressure and standing office blood pressure was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340383|NCT01939496|Secondary|Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||beats per minute||Standard Deviation|Mean
1340384|NCT01939496|Secondary|Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The seated heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||beats per minute||Standard Deviation|Mean
1340385|NCT01939496|Secondary|Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340422|NCT01939145|Other Pre-specified|Time to Closure|Compare the percent of wounds closed and the time to closure during the hospital admission and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||||||
1340387|NCT01939496|Secondary|Change From Baseline in Body Weight to Week 6|Body weight was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||Kilogram (kg)||Standard Deviation|Mean
1340388|NCT01939496|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6|The fasting plasma glucose was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1340389|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340390|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340391|NCT01939496|Secondary|Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340392|NCT01939496|Secondary|Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340393|NCT01939496|Secondary|Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340394|NCT01939496|Secondary|Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Day 2|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340395|NCT01939496|Primary|Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using last observation carried forward (LOCF) method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340396|NCT01939405|Secondary|Sedentary Time|Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.|4 months from baseline||||minutes||Standard Deviation|Median
1340397|NCT01939405|Secondary|Sedentary Time|Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers|Immediately post-intervention||||minutes||Standard Deviation|Median
1340398|NCT01939405|Secondary|Moderate-to-Vigorous Physical Activity (MVPA)|Longer term change in MVPA from baseline to 3-4 months post intervention|4 months from baseline||||minutes||Inter-Quartile Range|Median
1340399|NCT01939405|Primary|Moderate to Vigorous Physical Activity (MVPA)|Short-term change in MVPA from baseline to post-intervention|Immediately post-intervention||||minutes||Inter-Quartile Range|Median
1340400|NCT01939314|Secondary|Headache Free at 24 Hours|The percentage of patients that were headache free at 24 hours by follow-up phone conversation.|24 hours||||percentage of participants|||Number
1340401|NCT01939314|Secondary|Categorical Pain Relief|"Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as No, Little, Some, A Lot or Complete. The table displays the number of participants who identified their pain relief in the categories provided."|15 minutes from dose||||participants|||Number
1340402|NCT01939314|Primary|Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale||15 minutes from dose||||percentage of participants|||Number
1340423|NCT01939145|Secondary|Hospital Admission Length of Stay|Compare the hospital admission length of stay between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||days||Standard Deviation|Mean
1340403|NCT01939301|Primary|Number of Participants With Normal Right Ventricular (RV) Function and Viability|Right ventricular (RV) function and viability assessed by the composite of normal RV size (<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) > 16 mm and normal right ventricular index of myocardial performance (RIMP) < 0.40 using spectral Doppler or < 0.55 using tissue Doppler) and normal fractional area change (FAC) (> 33%) and a serum hsTnT < 14pg/mL. Missing values will be considered normal.|5 days or hospital discharge (whichever occurs first)||||Participants|||Count of Participants
1340404|NCT01939223|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.|Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn.|Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.||||||
1340405|NCT01939223|Primary|Disease Free Survival (DFS) as Assessed by the Investigator|Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.|From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.|Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.||||||
1340406|NCT01939197|Secondary|Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment|HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).|End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 – 98) or HIV Week 24 window (Treatment Day 155 – 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 – 126)|Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.|||percentage of participants||95% Confidence Interval|Number
1340407|NCT01939197|Secondary|Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment|HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).|End of treatment: HIV Week 12 window (Treatment Day 78 – 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 – 126)|Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1340408|NCT01939197|Secondary|Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment|HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).|End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 – 98) or HIV Week 24 window (Treatment Day 155 – 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 – 126)|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1340409|NCT01939197|Secondary|Percentage of Participants in Part 2 With Relapse12|Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.|up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received ≥1 dose of study drug, who completed treatment with HCV RNA < LLOQ at final treatment visit, and had ≥1 post-treatment HCV RNA value. Arm G data was not analyzed (see Outcome Measure 8).|||percentage of participants||95% Confidence Interval|Number
1340410|NCT01939197|Secondary|Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall|Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.|up to 12 weeks after the last actual dose of study drug|Intent-to-treat population: all Part 1b randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.|||percentage of participants||95% Confidence Interval|Number
1340424|NCT01939145|Primary|Number of Operating Room Visits|Compare the number of operative room visits between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||Operative Room Visits||Standard Deviation|Mean
1340474|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||percentage of participants|||Number
1340411|NCT01939197|Secondary|Percentage of Participants in Part 1a With Relapse12|Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.|up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.|||percentage of participants||95% Confidence Interval|Number
1340412|NCT01939197|Secondary|Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period|Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.|up to 12 or 24 weeks, based on treatment duration|Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.|||percentage of participants||95% Confidence Interval|Number
1340413|NCT01939197|Secondary|Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period|Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.|up to 12 weeks|Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1340414|NCT01939197|Secondary|Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period|Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.|up to 12 or 24 weeks, based on treatment duration|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1340415|NCT01939197|Secondary|Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
1340416|NCT01939197|Secondary|Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
1340417|NCT01939197|Secondary|Percentage of Participants in Part 1b Achieving SVR12|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
1340418|NCT01939197|Secondary|Percentage of Participants in Part 1a Achieving SVR12|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
1340419|NCT01939197|Primary|Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)|"SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution.~The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%)."|12 weeks after the last actual dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. The primary efficacy endpoint analysis was based on subjects in the GT 1 Analysis Group in Part 2 containing Arms E, F, H, I, and J.|||percentage of participants||95% Confidence Interval|Number
1340420|NCT01939145|Other Pre-specified|Bacterial Culture Results|Compare the qualitative bacterial culture results between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||||||
1340421|NCT01939145|Other Pre-specified|Wound Recidivism|Compare the percent of wounds that remained closed 30 days and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|30 days post discharge from hospital|||||||
1340425|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing|The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.|||participants|||Number
1340426|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing|The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.|||participants|||Number
1340427|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Antibody Screening|The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.|||participants|||Number
1340428|NCT01939002|Secondary|Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period|Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.|Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and had FLS; n=number of participants assessed at the given timepoint.|||hours||Standard Deviation|Mean
1340429|NCT01939002|Secondary|Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.|Day 1 to Week 52|Safety population: all participants who received at least 1 injection of study treatment.|||participants|||Number
1340430|NCT01939002|Secondary|Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population|Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.|Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340431|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.|||days||Standard Deviation|Mean
1340432|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.|||days||Standard Deviation|Mean
1340433|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.|||days||Standard Deviation|Mean
1340698|NCT01935947|Secondary|Overall Survival (OS)||From the time of enrollment to trial until death, assessed up to 2 years|Data was not collected to assess this outcome measure due to early study termination.||||||
1340434|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340435|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340436|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340437|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340438|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340439|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340440|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340441|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population|The TSQM assessed participants’ global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340442|NCT01939002|Secondary|Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS||during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.|||percentage of participants|||Number
1340935|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340443|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340444|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340445|NCT01939002|Secondary|Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340446|NCT01939002|Secondary|Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
1340447|NCT01939002|Secondary|Summary of Average Duration of FLS in the 48 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.|||hours||Full Range|Median
1340448|NCT01939002|Secondary|Summary of Average Duration of FLS in the First 8 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.|||hours||Full Range|Median
1340449|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||units on a scale||Standard Deviation|Mean
1340450|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||units on a scale||Standard Deviation|Mean
1340451|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
1340466|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
1340452|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
1340453|NCT01939002|Secondary|Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.|4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
1340454|NCT01939002|Secondary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
1340455|NCT01939002|Primary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population|The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
1340456|NCT01938989|Primary|Photostress Recovery Time|Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.|Day 1|This analysis population includes all participants with observation minus any major protocol deviations.|||seconds||Standard Deviation|Mean
1340457|NCT01938833|Secondary|Clinical Benefit Rate (CBR)|The 95% confidence intervals should be provided.|Up to 5 years|Data were not collected and the Outcome will never be analyzed.||||||
1340458|NCT01938833|Secondary|Overall Response Rate (ORR)|The 95% confidence intervals should be provided.|Up to 5 years|Data were not collected and the Outcome will never be analyzed.||||||
1340459|NCT01938833|Secondary|Incidence of Adverse Events, Graded According to NCI CTCAE Version 4.0|Summary tables of grade 2, 3, and 4 toxicities, adverse events (AE), and serious adverse events (SAE) will be generated at the conclusion of the study as well as at the conclusion of phase I study and after 15 patients have been collected on at the interim evaluation time point of the phase 2 part of the study.|Up to 30 days|Data were not collected and the Outcome will never be analyzed.||||||
1340460|NCT01938833|Primary|Progression-Free Survival (PFS)||The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years|Data were not collected and the Outcome will never be analyzed||||||
1340461|NCT01938833|Primary|Maximum-Tolerated Dose of Romidepsin (Phase I)|Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0|28 days|Data were not collected and the Outcome will never be analyzed.||||||
1340462|NCT01938573|Secondary|Incidence of Adverse Events Including Any Unfavorable and Unintended Sign, Symptom, Diagnosis, or Disease Temporally Associated With the Use of a Medicinal Product, Whether or Not Related to the Medicinal Product (Phase I and II)|Graded according to the NCI CTCAE version 4.0. Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline). All adverse events resulting in discontinuation, dose modification, dosing interruption, and/or treatment delay of study drug will also be listed and tabulated by preferred term.|Up to 28 days after completion of study treatment||||Number of events|||Number
1340463|NCT01938573|Primary|Percent of Patients With Pathologic Complete Response (Phase II)|The study will follow an optimal two-stage Simon design based on pathologic complete response rate.|12 weeks|Patients treated in phase 2|||Participants|||Count of Participants
1340464|NCT01938573|Primary|Patients With Dose Limiting Toxicity|Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline).|Up to 28 days||||Participants|||Count of Participants
1340465|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
1340467|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1340475|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||percentage of participants|||Number
1340476|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1340477|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1340478|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1340479|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1340480|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1340481|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants|||Number
1340482|NCT01938430|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttransplant Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.|||percentage of participants|||Number
1340483|NCT01938430|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.|||percentage of participants|||Number
1340484|NCT01938430|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.|||percentage of participants|||Number
1340485|NCT01938430|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.|||percentage of participants|||Number
1340486|NCT01938430|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.|||percentage of participants|||Number
1340487|NCT01938430|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.|||percentage of participants|||Number
1340488|NCT01938430|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1340489|NCT01938430|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.|||percentage of participants|||Number
1340490|NCT01938391|Primary|Percent (%) Area Stenosis|Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area).|Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)|At the time of analysis 24 of 29 lesions in 25 participants could be assess by the IVUS Core Lab.|||percent area stenosis|lesions|Inter-Quartile Range|Median
1340491|NCT01938391|Primary|Stent Usage at the Time of the Index Procedure|Number of lesions with a stent placed during the index procedure.|Index Procedure|Number of stents placed is based on number of lesions treated in the total subject population of 25. The total number of lesions treated were 29 and of those 29 lesions, 17 had a stent placed.|||Lesions|Lesions||Number
1340492|NCT01938391|Primary|Rutherford Classification (RC)|"Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit.~RC classification is as follows:~RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable"|Baseline, 2 weeks, 6 month and 12 month|At the time of analysis for the 6 month visit 1 participant missed their follow up visit. At the time of analysis for the 12 month visit, 22 participants completed the 12 month follow up visit.|||Participants|||Count of Participants
1341873|NCT01923480|Secondary|Plasma Concentration of Alanine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1340493|NCT01938391|Primary|Ankle-Brachial Index (ABI) Measurments|The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel.|Baseline, 2 weeks, 6 months and 12 months|At the time of this analysis 3 of the subjects did not have their ABI measured at baseline, 1 participant did not have their ABI measured at 2 weeks, 1 participant did not have their ABI measured at 6 months and 1 participant did not have their ABI measured at 12 months.|||ratio||Standard Deviation|Mean
1340494|NCT01938391|Primary|Rate of Procedural Angiographic Complications|Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).|Index Procedure||||Participants|||Count of Participants
1340495|NCT01938391|Primary|Mean Maximum Balloon Inflation Pressure|Mean maximum balloon inflation pressure of balloons used pre-stent placement.|Index Procedure||||atm|balloons|Standard Deviation|Mean
1340496|NCT01938391|Primary|Rate of Clinically Driven Target Lesion Revascularization (TLR)|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.|6 months and 12 months||||% probablity of clinically driven TLR||95% Confidence Interval|Number
1340497|NCT01938170|Secondary|Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home|This study will also assess the feasibility of having parents/caregivers administer Flumist vaccine outside a traditional medical environment and without the direct participation of medical personnel. We will ask parents by telephone survey at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home, about maintaining temperature and conditions proper for vaccine storage until administration. We will also ask about ease of vaccine disposal and about child preferences for receiving vaccine at home compared to at a dedicated medical visit.|0-12 days||||participants|||Number
1340498|NCT01938170|Primary|Number of Subjects That Reported Successful Home Vaccination With no Adverse Events|We will assess the tolerability of giving the FluMist nasal vaccine at home by parents/caregivers to their children by performing telephone survey follow up. We will ask parents at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home and any adverse events encountered when giving FluMist at home.|0-12 days||||participants|||Number
1340499|NCT01938079|Primary|Cumulative Fentanyl Equivalents From ECMO Initiation to Decision to Achieve Wakefulness|Culmulative fentanyl equivalents meaning the combination of sedative drug regimen - measured in mg - from ECMO initiation to decision to achieve wakefulness.|Up to 14 days||||mg||Inter-Quartile Range|Median
1340500|NCT01938066|Secondary|Amount of Pain Medication Used (Morphine)|will measure the amount of pain medication used (morphine)|5 days||||mg||Standard Deviation|Mean
1340501|NCT01938066|Primary|Wound Infection|At the end of 5 days all subjects will get a Culture and Sensitivity to see if they have an infection or what type of infection they have in the wound|At the end of 5 days||||participants|||Number
1340502|NCT01938040|Secondary|Geriatric Depression Scale|15 questions. Score 1 point for each answer selected which indicates depression. Score of 0-5 is normal. A score >5 suggests depression.|Preoperatively, post operative day 1 and post op day3||||units on a scale||Standard Deviation|Mean
1340503|NCT01938040|Secondary|Cognitive Recovery.|Digits span forward subject is asked to repeat a series of numbers with increasing number of digits forward. Digit span backward subject is asked to repeat a series of numbers backward with increasing number of digits. Correct response is worth 1 point. Maximum of 14 points for each sub score with a total of 28 points for total score|preoperatively- 2 hours in PACU, Post op day #1, post op day#3||||units on a scale||Standard Deviation|Mean
1340504|NCT01938040|Other Pre-specified|Cytokine Concentrations|IFN y, IL-1B IL-2 were below the limit of detection and no assessments could be made. The lower limit for all cytokine detection was 3.2pg/mL|preoperative-intraoperative-postopoperative|||||||
1340505|NCT01938040|Secondary|Immune Response:Serum Concentration of IL-10,|.drawn in PACU 2 hours following arrival and compared to preoperative and intraoperative values|2 hours post arrival in PACU||||pg/mL||Full Range|Mean
1340506|NCT01938040|Secondary|Modified Fatigue Severity Scale|This questionnaire contains 9 statements that rate severity of fatigue symptoms. Score 1 indicates strong disagreement with the statement and 7= strong agreement. i.e (I am easily fatigued).Total lowest possible score indicating no fatigue is 9. Total highest possible score is 63 which correlates to severe fatigue, interfering with all activities of daily living.|preoperative-postoperative day 1 and day 3||||scores on a scale||Standard Deviation|Mean
1340507|NCT01938040|Secondary|Quality of Recovery-40|Quality of Recovery-40 has been used to assess postoperative recovery from anesthesia where higher score correlate with improved recovery and well being. The survey has 5 domains: comfort scale ranges 1-60 with higher value indicating greater comfort, emotions scale ranges 1-45 with higher value indicating best emotional state, physical independence scale ranges 1-25 with higher value indicating best independence, patient support scale ranges 1-35 with a higher score indicating greater support and pain scale 1-35 with higher number indicating greater relief from pain. Scoring is done for PART A on a scale of 1-5 (1=very poor=none of the time, worst score, 5=excellent=all of the time, best possible score).PART B on a scale of 1-5 (1=very poor or all the time worse score), 5=excellent or none of the time, best score) Perfect score=200.|preoperatively and -postoperative days 1 and 3||||units on a scale||Standard Deviation|Mean
1340508|NCT01938040|Secondary|Immune Response IL-6||2 hours postoperatively in PACU||||pg/mL||Full Range|Mean
1340509|NCT01938040|Post-Hoc|IL-6||preoperatively-intraoperatively-postoperatively||||pg/mL||Full Range|Mean
1340510|NCT01938040|Post-Hoc|Immune Response: TNF Alpha||preoperatively-intraoperatively-postoperatively||||pg/mL||Full Range|Mean
1340511|NCT01938040|Post-Hoc|Sympathetic Response: Epinephrine and Norepinephrine Plasma Concentrations||intraoperatively||||pg/mL||Standard Deviation|Mean
1340512|NCT01938040|Primary|Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP)|Serum concentration of cortisol, CRP, drawn in Post Anesthesia Care unit at 2 hours following surgery were compared with those same levels drawn preoperatively and intraoperatively.|2 hours following end of surgery||||pg/mL||Standard Deviation|Mean
1340513|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Liters||95% Confidence Interval|Geometric Mean
1340514|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Liters/hr||95% Confidence Interval|Geometric Mean
1340515|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1340516|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hours||Full Range|Median
1340517|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM||95% Confidence Interval|Geometric Mean
1340518|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
1340519|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||95% Confidence Interval|Geometric Mean
1340520|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Liters||95% Confidence Interval|Geometric Mean
1340521|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Liters/hr||95% Confidence Interval|Geometric Mean
1340522|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1340523|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hours||Full Range|Median
1340524|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM||95% Confidence Interval|Geometric Mean
1340525|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
1340526|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||95% Confidence Interval|Geometric Mean
1340527|NCT01937871|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2|The modified IPSS is the total IPSS collected at 2 weeks post-baseline.The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.|Baseline, Week 2|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline mIPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1340528|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
1340529|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score is determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
1340530|NCT01937871|Secondary|Change From Baseline in IIEF EF at Week 4 and Week 8|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
1340531|NCT01937871|Secondary|Change From Baseline in Total IPSS at Week 4 and Week 8|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1340532|NCT01937871|Secondary|Change From Baseline in IIEF Subscores at Week 12|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
1340533|NCT01937871|Secondary|Change From Baseline in IIEF Sexual Desire at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
1340534|NCT01937871|Secondary|Change From Baseline in IIEF Orgasmic Function at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
1340535|NCT01937871|Secondary|Change From Baseline in IIEF Intercourse Satisfaction at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
1340536|NCT01937871|Secondary|Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
1340537|NCT01937871|Secondary|Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12|CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline CGI-I measurement.|||Participants|||Count of Participants
1340538|NCT01937871|Secondary|Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PGI-I measurement.|||Participants|||Count of Participants
1340586|NCT01937520|Secondary|Tumor Necrosis Factor (TNF)|First two blood samples were collected during general anesthesia, first prior to surgical incision and Electro-acupuncture (EA), 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia. TNF is a critical pyrogen produced during acute phase of a reaction to trauma.|preoperatively-intraoperatively-postoperatively|female subjects|||pg/ml||Standard Error|Mean
1340539|NCT01937871|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12|"IPSS QoL assess participant response to the following question:If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline QoL measurement.|||units on a scale||Standard Error|Least Squares Mean
1340540|NCT01937871|Secondary|Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12|IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1340541|NCT01937871|Secondary|Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12|IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1340542|NCT01937871|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at Week 12|The amount of urine remaining in the bladder after void completion.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PVR measurement.|||milliliters (mL)||Standard Deviation|Mean
1340543|NCT01937871|Secondary|Change From Baseline in Uroflowmetry Measures at Week 12|"Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter).~At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline Uroflowmetry measurement.|||Milliliters/seconds (mL/sec)||Standard Deviation|Mean
1340544|NCT01937871|Secondary|Change From Baseline in IPSS at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1340545|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?.The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
1341986|NCT01922037|Secondary|Total Number of Asthma-Related Hospital Admissions During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related hospital admissions||Standard Deviation|Mean
1340546|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of “yes” responses at endpoint minus the percentage of “yes” responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
1340547|NCT01937871|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12|IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who had at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
1340548|NCT01937871|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1340549|NCT01937715|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C) (Phase 2)|The FACT-C was to assess health-related quality of life and colorectal cancer (CRC)-related symptoms. It includes a total of 36 items, which are summarized into 6 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), CRC subscale (9 items) which addresses a subset of CRC concerns such as diarrhea.|Day 1 of each cycle|FACT-C was only applicable to the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.||||||
1340550|NCT01937715|Secondary|Number of Participants With Evidence of Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue (Phase 2)|Biomarker evaluation were to be performed on these fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Levels of signaling proteins in biopsied tumor tissue was the secondary endpoint for the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.||||||
1340551|NCT01937715|Secondary|Overall Survival (Phase 2)|Overall survival is the time from randomization date to date of death due to any cause.|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.||||||
1340552|NCT01937715|Secondary|Duration of Response (Phase 2)|Duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death.|Day 1 to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.||||||
1340553|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 2)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.||||||
1342342|NCT01916681|Primary|Length of Stay|Total maternal length of stay as defined as days from the day the induction began to the day of discharge|Days between admit to hospital and discharge||||Days||Inter-Quartile Range|Median
1340554|NCT01937715|Secondary|Number of Participants With Gene and/or Protein Expression Biomarkers Relating to the PI3K and/or mTOR Pathway Activation in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.||||||
1340555|NCT01937715|Secondary|Number of Participants With Expression of Gene Sequences or Gene Amplications in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.||||||
1340556|NCT01937715|Secondary|Number of Participants Meeting Maximum Post-Baseline QTc Interval Values|Criteria for corrected QT interval using Fridericia's formula (QTcF) meeting potential clinical concern included: an absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; an absolute change 30 - <60, >=60 msec.|Baseline, Cycle 1 Day 1, and Cycle 2 Day 2|All participants who received at least 1 dose of study medication.|||participants|||Number
1340557|NCT01937715|Secondary|Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan|Terminal Elimination Half-Life of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||hour||Standard Deviation|Mean
1340558|NCT01937715|Secondary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf): PF-05212384 and Irinotecan|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1340559|NCT01937715|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-05212384 and Irinotecan|Area Under the Curve From Time Zero to Last Quantifiable Concentration of PF-05212384, and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1340560|NCT01937715|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): PF-05212384, Irinotecan, and Fluorouracil|Time to Reach Maximum Observed Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||hour (hr)||Full Range|Median
1340561|NCT01937715|Secondary|Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil|Maximum Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1340562|NCT01937715|Secondary|Number of Participants With Urinalysis Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Urinalysis test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication.|||participants|||Number
1340563|NCT01937715|Secondary|Number of Participants With Chemistry Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Chemistry test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.|||participants|||Number
1340564|NCT01937715|Secondary|Number of Participants With Coagulation Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Coagulation test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.|||participants|||Number
1340565|NCT01937715|Secondary|Number of Participants With Hematological Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 hematological test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication.|||participants|||Number
1340566|NCT01937715|Secondary|Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AE grades were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.|||participants|||Number
1340567|NCT01937715|Secondary|Number of Participants With All Causality AEs by System Organ Class (SOC)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.|||participants|||Number
1340568|NCT01937715|Secondary|Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the event occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment; or the event was seen prior to the start of treatment but increased in CTCAE version 4.0 grade after the start of study treatment and within 28 days after final dose of study treatment.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.|||participants|||Number
1340569|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 1B)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose|All participants in the full analysis (FA) set who had measureable disease and an adequate baseline assessment of the disease.|||participants|||Number
1340570|NCT01937715|Primary|Progression-Free Survival (PFS)|Progression-free survival was the time from randomization the date to date of first documentation of progression or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)|PFS was the primary efficacy endpoint for the study and was only to be assessed in the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2.||||||
1340571|NCT01937715|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy|DLTs were classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and defined as any of the following events judged to be attributed to the combination of PF-05212384 plus FOLFIRI: hematologic (febrile neutropenia or a sustained temperature >=38 degrees Celcius for >1 hour, grade >=3 neutropenic infection, grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia); non-hematologic (grade >=2 pneumonitis, grade >=3 toxicities, toxicities which resulted in failure to deliver at least 75% of the planned total dose of PF-05212384 and/or 50% of the planned total dose of FOLFIRI during the first cycle, toxicities which resulted in delay of start of Cycle 2 by >2 weeks of scheduled day (Day 43 of study), Grade 3 QTc prolongation).|Day 1 up to Day 28|The dose limiting toxicity analysis set included participants in Phase 1B who started treatment and who did not have a major treatment deviation in the lead-in period and the first cycle of treatment.|||percentage of participants|||Number
1340572|NCT01937598|Secondary|AUC Active GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
1340573|NCT01937598|Secondary|AUC Active GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
1340574|NCT01937598|Secondary|AUC Total GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
1340575|NCT01937598|Secondary|AUC Total GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
1340576|NCT01937598|Secondary|AUC Glucagon||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
1340577|NCT01937598|Secondary|AUC C-peptide||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||nmol/l*min||Standard Error|Mean
1340578|NCT01937598|Secondary|AUC Insulin||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||nmol/l*min||Standard Error|Mean
1340579|NCT01937598|Secondary|AUC Plasma Glucose|Incremental AUC from 0 to 300 min|Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||mmol/l*min||Standard Error|Mean
1340580|NCT01937598|Primary|Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)|Incremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test.|0 to 300 min post mixed meal test||||[mg*min/dL]||Standard Error|Mean
1340581|NCT01937520|Secondary|Serum Insulin Level|to determine if electroacupuncture reduced hyperglycemia|preoperative and postoperative|female subjects preoperatively and postoperatively|||pg/ml||Standard Error|Mean
1340582|NCT01937520|Secondary|TGFB1|TGFB1 is a pleiotropic factor regulating the immune system and healing. First two blood samples drawn under general anesthesia, first prior to surgical incision and EA, the 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|all females; then females by groups age (<45 years and >45 years) and weight (<75kg and >75kg)|||pg/ml||Standard Error|Mean
1340583|NCT01937520|Secondary|IL-10|IL-10 is an anti-inflammatory cytokine marker. First two blood samples were collected during general anesthesia, first prior to surgical incision and EA, 2nd 60 minutes following incision and EA, and the third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|total females; then those grouped by age (<45years and>45 years) and weight (<75 Kg and >75kg)|||pg/ml||Standard Error|Mean
1340584|NCT01937520|Secondary|IL-6|First two blood samples were collected during general anesthesia, first prior to Surgical incision and EA, 2nd 60 minutes after incision and EA and the 3rd after arrival in PACU but before administration of analgesia. IL-6 is a critical inflammatory cytokine produced during the acute phase of reaction to trauma|Preoperatively-intraoperatively-postoperatively|total female results; then females divided into age groups (<45 or >45years) and weights groups (<75kg and >75kg)|||pg/ml||Standard Error|Mean
1340585|NCT01937520|Secondary|iNTERLEUKIN (IL-2 and IL-4)|both are IL-2 and IL-4 are critical cytokines regulating the cellular response to induce cellular versus hormone immunity. First two blood samples were collected during general anesthesia: first prior to surgical incision and electroacupuncture, second 60 minutes after incision and electroacupuncture and the 3rd after arrival in PACU but before analgesia.|Preoperatively-intraoperatively-postoperatively|all females|||pg/ml||Standard Error|Mean
1340587|NCT01937520|Secondary|Glucose|the first two blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|serum glucose from baseline to PACU arrival|females|||mg/dL||Standard Error|Mean
1340589|NCT01937520|Primary|Morphine Equivalent|equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.|PACU, day 1 , day 2, day 3|since gender impacts the threshold for analgesic and pain the effects of electroacupuncture on females was analyzed. The same number of females were in both groups but since one subject had preexisting levels of TNF>1ug/ml prior to surgery she was eliminated from the dta base|||mg morphine||Standard Error|Mean
1340590|NCT01937520|Secondary|Cortisol|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|prior to surgical incision, 1 hour following incision, after arrival in PACU|females|||ng/ml||Standard Error|Mean
1340591|NCT01937520|Secondary|Modified Quality of Recovery Scale|Modified patient self reported scale with 9 questions regarding general well being including ability to eat, free from constant pain, able to manage activities of daily living. 0= worst possible score and 18=best outcome score|Day 1, 2, 3|all females|||units on a scale||Standard Error|Mean
1340592|NCT01937520|Secondary|Morphine Equivalent (mg)|morphine equivalent to analyze whether body weight affected the efficacy of electroacupuncture|PACU arrival to 2 hours post op|females with body weight <75 kg and >than 75 kg|||mg morphine||Standard Error|Mean
1340593|NCT01937520|Secondary|Morphine Equivalent|All analgesic treatments were converted to morphine equivalents in milligrams .|PACU to 2 hours post op|females grouped by age (<45 years and 45 years or greater)|||mg of Morphine||Standard Error|Mean
1340594|NCT01937520|Secondary|(ACTH )Adrenocorticotropic Hormone|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia. The data below represents female patients only|serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACU|females|||pg/ml||Standard Error|Mean
1340595|NCT01937520|Primary|Visual Acuity Score (VAS)|VAS is a self reported pain scale with a score ranging from 0 to 10. 0= no pain, 10=worst pain possible. Multiple pain sacores were recorded. single value is reported by average|arrival in PACU to 2 hours post operatively|all study participants|||units on a scale||Standard Error|Mean
1340596|NCT01937520|Primary|Reduced Pain Medication Requirement|analgesia provided in Post Anesthesia Care Unit PACU)|amount of pain medication provided in PACU|All subjects enrolled in study|||mg of Morphine||Standard Error|Mean
1340597|NCT01937507|Secondary|To Document the Toxicity, Tolerability of the Therapy in This Population.|Document the toxicity and tolerability of the therapy using the following CBC with differential, BUN, creatinine, liver function tests,CA 15-3, CA 27.29, Circulating tumor cells (CTCs)and Restaging radiographic studies (MRI or CT liver protocol).|one year|Data was not collected||||||
1340598|NCT01937507|Primary|Extra-hepatic Progression (TEP) of HAI With Oxaliplatin/5-FU|To determine time to extra-hepatic progression (TEP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.|One year|Data was not collected||||||
1340599|NCT01937507|Primary|Determine Time to Intra-hepatic Progression (TIP) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.|To determine time to intra-hepatic progression (TIP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.|One year|Data was not collected||||||
1340600|NCT01937507|Primary|Determine Response Rate (RR) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.|To determine response rate (RR) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.|One year|Data was not collected||||||
1340601|NCT01937390|Secondary|Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients|Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented.|13 months|ITT|||Percentage of participants|||Number
1340602|NCT01937390|Primary|Number of COPD Exacerbations, Per Patient|"Percentage of subjects experienced COPD exacerbations exactly n number of times during the study period is presented. Here, n represents the number of times each subject experienced COPD exacerbations."|13 months|ITT|||Percentage of participants|||Number
1340603|NCT01937390|Primary|Number of COPD Exacerbations Leading to Hospitalization, Per Patient|"Percentage of subjects hospitalized due to COPD exacerbations exactly n number of times during the study period is presented. Here, n represents the number of times each subject is hospitalized due to COPD exacerbations."|13 months|ITT|||Percentage of participants|||Number
1340604|NCT01937390|Primary|CCQ Total Score at Month 13 (Visit 4)|Mean and standard deviation of CCQ total score is presented at month 13.|13 months|ITT (observed cases)|||Units on a scale||Standard Deviation|Mean
1340605|NCT01937390|Primary|Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13|"The Clinical COPD (Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) is a standardized, validated and reliable questionnaire (in local language) to assess the impact of treatment on health status in COPD patients. CCQ total score is calculated as the arithmetic average of 10 individual scores on a 7-point scale. CCQ total score varies from 0 (very good control) to 6 (extremely poor control). Mean change in CCQ total score from baseline at month 13 is presented along with its standard error. Change in CCQ total score is calculated for each subject as:~CCQ total score at month 13 - CCQ total score at baseline. Baseline is defined as the first assessment after enrolment (at Month 1)."|Baseline and 13 Month|Intent-to-treat (ITT): This population set included all subjects who signed informed consent form (ICF), satisfied all inclusion and exclusion criteria and have taken at least one dose of study drug.|||Units on a scale||Standard Error|Mean
1340606|NCT01937364|Secondary|Peak and Total Benzodiazepine Dose Required||72 hours||||Doses||Inter-Quartile Range|Median
1340607|NCT01937364|Secondary|Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment|Range: 0 to 67; larger values indicate greater severity|72 hours|All CIWA-Ar scores collected at and after the baseline measurement.|||units on a scale||Standard Error|Mean
1340608|NCT01937364|Primary|Moderate or Severe Alcohol Withdrawal Syndrome|Moderate or severe AWS was defined as a CIWA-AR score of at least 11.|72 hours|Subjects who either had AWS prior to the collection of the 72-hour CIWA-Ar score or had a CIWA-Ar score either recorded as the 72-hour CIWA-Ar score or occurring within the one-hour window for the 72-hour CIWA-Ar score are evaluable for this endpoint.|||Participants|||Count of Participants
1340609|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Changes in Quality of Life measures from Baseline at 30 days and 6 months using Short Form (SF)-12 & Vascular Quality of Life (VascuQoL).|Day 0, Day 60 and 6 Months||2017-04-30|04/2017||||
1340610|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Rutherford Classification at 30 days and 6 months.|Day 0, Day 30 and 6 Months|||||||
1340611|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Ankle-Brachial Index at 30 days and 6 months.|Day 30 and 6 Months|||||||
1340612|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Procedural success defined as the percent of target lesions that have residual diameter stenosis < 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.|Day 0|||||||
1340613|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.|Day 0 through 6 Months||2017-04-30|04/2017||||
1340614|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.|Day 0|||||||
1340615|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.|Day 0 through Day 30||||percentage of subjects|||Number
1340616|NCT01937351|Primary|Primary Effectiveness Endpoint|The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis <50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.|Day 0|Analysis was performed on per protocol cohort, and results were calculated based on number of lesions that were treated.|||percentage of lesions|lesions||Number
1340617|NCT01937351|Primary|Primary Safety Endpoint|"The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include:~Cardiovascular related death~Unplanned, major index limb amputation~Clinically driven target lesion revascularization (TLR)~Myocardial infarction~Device related events:~Clinically significant perforation~Clinically significant dissection~Clinically significant embolus~Pseudoaneurysm"|Day 0 through 6 Months|All per-protocol subjects who completed the 6-month follow-up were included in the analysis|||percentage of subjects|||Number
1340618|NCT01937312|Secondary|Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
1340619|NCT01937312|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||percent change||Standard Deviation|Mean
1340620|NCT01937312|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
1340621|NCT01937312|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
1340635|NCT01937130|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"|||RLU||Inter-Quartile Range|Median
1342343|NCT01916681|Primary|Time to Delivery|Amount of hours that pass between the start of the induction to delivery.|Hours between start of induction to delivery||||Hours||Inter-Quartile Range|Median
1340622|NCT01937299|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.|||percent change||Standard Deviation|Mean
1340623|NCT01937299|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
1340624|NCT01937299|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
1340625|NCT01937260|Primary|The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2|Day 1 to Day 9|20 subjects are now analyzed after the discontinuation of 1 subject by sponsor decision|||hr*ng/mL||Standard Deviation|Mean
1340626|NCT01937260|Primary|The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on day 30|Day 1 to Day 9|20 subjects analyzed after the discontinuation of 1 subject by sponsor decision|||hr*ng/mL||Standard Deviation|Mean
1340627|NCT01937260|Primary|The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30|Day 1 to day 9|Analysis population is now 20 subjects after 1 subject was discontinued by sponsor decision|||nanograms per milliliter||Standard Deviation|Mean
1340628|NCT01937195|Secondary|"Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Removal"|Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.|At catheter removal, which is expected to be up to 7 days post placement|Inpatients requiring IV therapy|||percentage of participants||95% Confidence Interval|Number
1340629|NCT01937195|Secondary|Number of Participants Experiencing Adverse Events|Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.|baseline, and up to catheter removal expected to be no more than 7 days post placement|Inpatients requiring IV therapy.|||participants|||Number
1340630|NCT01937195|Secondary|"Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Insertion"|Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.|Baseline at catheter insertion in the first 3-15 minutes after procedure|Inpatients requiring IV therapy|||percentage of participants||95% Confidence Interval|Number
1340631|NCT01937195|Secondary|Catheter Dwell Time|Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.|Study exit/at catheter removal expected to be up to 7 days post placement||||hours||95% Confidence Interval|Mean
1340632|NCT01937195|Secondary|Completion of IV Therapy|Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).|Study exit/at catheter removal expected to be up to 7 days post placement|Inpatients requiring IV therapy.|||Participants|||Count of Participants
1340633|NCT01937195|Secondary|Percentage of Patients With Complications of Peripheral IV Therapy|Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).|Study exit/at catheter removal expected to be up to 7 days post placement|Inpatient units requiring IV therapy.|||percentage of patients||95% Confidence Interval|Number
1340634|NCT01937195|Primary|Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt|The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.|Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure|Inpatients requiring IV therapy.|||percentage of participants||95% Confidence Interval|Number
1342344|NCT01916629|Primary|Percent Lesion Clearance||90 days||||Percent Clearance||Standard Deviation|Mean
1340636|NCT01937130|Secondary|Levels of CK18/M65|Caspase full-length cytokeratin serum levels CK18/M65|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"|||U/L||Inter-Quartile Range|Median
1340637|NCT01937130|Secondary|Levels of CK18/M30|Caspase-cleaved cytokeratin serum levels (CK18/M30)|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"|||U/L||Inter-Quartile Range|Median
1340638|NCT01937130|Primary|Tmax & t1/2 Parameters|Primary endpoints for tmax & t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days|"t1/2 number of participants analyzed at Day 1 in the 5mg arm was 2 and 1 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values."|||(h)|Participants|Standard Deviation|Mean
1340639|NCT01937130|Primary|Cmax|Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days||||(ng/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
1340640|NCT01937130|Primary|Area Under the Curve (AUC)|Primary endpoints for AUC_0-8, AUC_0 last, AUC_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.|28 days|"AUC_0-last: The number of participants analyzed in the 25mg arm was 7 at Day 1 AUC_0-inf: The number of participants analyzed in the 5mg arm was 2 at Day 1 and 0 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values."|||h*ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
1340641|NCT01937026|Primary|PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib||Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1340642|NCT01937026|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1340643|NCT01936974|Primary|Progression-free Survival|Evaluate progression-free survival between the two regimens.|One Year|Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.||||||
1340644|NCT01936909|Secondary|Death or Hospital Admission for Heart Failure|We will monitor survival and hospitalization for heart failure throughout the 24 week follow-up|24 weeks|All analyses were restricted to patients with a minimum of 2 weeks follow-up.|||participants|||Number
1340645|NCT01936909|Secondary|Quality of Life Improvement|The Duke Activity Status Index questionnaire will be completed at enrollment and 12 weeks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores represent increased ability to perform daily activities and may be interpreted as improved quality of life.|12 weeks|Patients with baseline and follow-up data|||units on a scale||Inter-Quartile Range|Median
1340646|NCT01936909|Primary|Interval Changes in Peak Oxygen Consumption (VO2)|Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.|Baseline to 2 weeks|Patients who completed baseline and 2 week exercise evaluation|||mL/kg/min||Inter-Quartile Range|Median
1340647|NCT01936896|Other Pre-specified|Safety|We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.|3 months|||||||
1340648|NCT01936896|Secondary|Left Ventricular End-systolic Volume Change|We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography|3 months|Only 5 patients had paired (i.e. baseline and 3 months) echocardiograms for evaluation|||mL||Inter-Quartile Range|Median
1340649|NCT01936896|Primary|C Reactive Protein (Area Under the Curve)|A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.|14 days||||mg/L||Inter-Quartile Range|Median
1340650|NCT01936870|Secondary|Change From Baseline in the Overactive Bladder Symptom Score (OABSS)|Overactive Bladder Symptom Score (OABSS) was defined as the sum score (0 to 15) of the following four OAB symptoms: daytime frequency (2 at maximum), nighttime frequency (3 at maximum), urgency (5 at maximum), and urgency incontinence (5 at maximum). Higher score indicates worse symptoms. Mean change from baseline in the OABSS at 12 weeks was presented along with the corresponding standard deviation.|Baseline, 12 Weeks|The effectiveness analysis set comprised of participants from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use. Participants with observed change in OABSS were included in table.|||Scale||Standard Deviation|Mean
1340651|NCT01936870|Secondary|Satisfaction Rate|Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed.|12 Weeks|The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.|||Percentage||95% Confidence Interval|Number
1340682|NCT01936363|Secondary|Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409||Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43|As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.||||||
1348307|NCT01824446|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Up to 288 hours post-dose|PAS|||hours||Standard Deviation|Mean
1340652|NCT01936870|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.|12 Weeks|The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.|||Percentage||95% Confidence Interval|Number
1340653|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
1340654|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 or CYP2D6 Inhibitors|Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin. Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
1340655|NCT01936870|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation.|Baseline, 12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Participants with observed change in MMSE score were included in table.|||Scale||Standard Deviation|Mean
1340656|NCT01936870|Secondary|Number of Participants With Adverse Events Related to Cognitive Function Disorder|An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ).|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
1340657|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
1340658|NCT01936870|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
1340659|NCT01936870|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
1340660|NCT01936844|Secondary|Brachial Artery Vasoreactivity|Change in flow mediated vasodilatation (FMD) of the brachial artery. Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. The change is FMD is reported as the % change in FMD from baseline to 14 days.|14 days|Some patients did not undergo assessment at 14 days because they did not show up to their scheduled appointment.|||percentage change||Inter-Quartile Range|Median
1340661|NCT01936844|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction (LVEF) between admission and 14 day follow up. This value is expressed as absolute change in measured LVEF. For example, if baseline LVEF = 20% and 14 day LVEF = 25%, this would be reported as an absolute change of 5%.|14 days|Some patients did not undergo LVEF assessment at 14 days because they did not show up to their scheduled appointment.|||percent LVEF||Inter-Quartile Range|Median
1340662|NCT01936844|Primary|C Reactive Protein|"The proportional area-under-the-curve for plasma C reactive protein (CRP) levels measured during the first 3 days of admission. The proportion (y-axis) is calculated at each time-point with respect to the baseline CRP. The resultant y-axis is a unitless proportion. The x-axis is listed as days"|3 days|1 patient in each group withdrew from the study prior to collection of data for the primary endpoint.|||days||Inter-Quartile Range|Median
1340663|NCT01936662|Secondary|OR to Discharge (Min)|Overall time from arrival in the OR to discharge home (in minutes)|OR to discharge||||Minutes||Standard Deviation|Mean
1340664|NCT01936662|Primary|Endoscopist Satisfaction|"Endoscopist was surveyed to determine their satisfaction with each of the airway devices.~Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:~The airway device did not interfere at all with the ability to perform the scope.~The airway device presented some interference with the scope, but not enough to cause difficulty.~The airway device made it difficult to perform the endoscopy.~The airway device prevented the endoscopy from being performed."|2 hours||||units on a scale||Standard Deviation|Median
1340665|NCT01936649|Secondary|To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection)|Measurements of H/M ratio and the extent of difference between H/M measurements following AdreView administration and 15 minutes delayed planar imaging on 2 separate days within an interval of 5 to 14 days, was used to assess the test-retest reproducibility. Data from test-retest study was used to estimate the normal ranges for variation in quantitation of myocardial tracer uptake using AdreView. H/M ratios were calculated by 3 technologists and average of 3 technologists was calculated based on non-missing technologists reviewing results. All non-missing technologist evaluations were averaged per participant.|15 minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView; had at least an interpretable planar image acquisition at 15 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.|||Ratio||Standard Deviation|Mean
1340666|NCT01936649|Primary|To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection)|Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability.|3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView (Iobenguane I 123 Injection); had at least an interpretable planar image acquisition at 3 hours 50 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.|||Ratio||Standard Deviation|Mean
1340667|NCT01936623|Other Pre-specified|Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids|Radioimmunoassay Testing (RIA) was conducted|6-month follow-up|Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.|||Participants|||Count of Participants
1340668|NCT01936623|Other Pre-specified|Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.|Radioimmunoassay (RIA) Tests were used.|3-month|Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.|||Participants|||Count of Participants
1340669|NCT01936623|Secondary|Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score|The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.|6-month follow-up||||units on a scale||Standard Error|Least Squares Mean
1340670|NCT01936623|Primary|Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score|The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.|3 month follow-up||||units on a scale||Standard Error|Least Squares Mean
1340671|NCT01936467|Secondary|Diagnostic Accuracy of EUS-FNA|The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease|6 months||||percent accurate|||Number
1340672|NCT01936467|Secondary|Acquisition of Core Tissue|The rate of acquiring core tissue of the pancreatic mass through EUS-FNA|immediate||||participants|||Number
1340673|NCT01936467|Secondary|First Pass Diagnostic Rate|The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass|immediate||||participants|||Number
1340674|NCT01936467|Primary|Sensitivity of EUS-FNA|Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.|||percentage of positive gold standard|||Number
1340675|NCT01936467|Primary|Sensitivity of EUS-FNA With StandardTechnique|Sensitivity of the EUS-FNA with Capillary technique|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.|||Participants|||Number
1340676|NCT01936467|Primary|Sensitivity of EUS-FNA With Capillary Technique|Sensitivity of the EUS-FNA with Capillary technique|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.|||participants|||Number
1340677|NCT01936467|Primary|Diagnostic Yield of Standard Technique|Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.|up to 6 months||||percentage of specimen|||Number
1340678|NCT01936467|Primary|Diagnostic Yield of Capillary Technique|Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.|up to 6 months||||percentage of specimen|||Number
1340679|NCT01936389|Primary|Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)|Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.|6 months||||mmHg||Standard Deviation|Mean
1340680|NCT01936363|Secondary|Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood||Screening visit (day -28 to 1)|As per changed in planned analysis the outcome measure related to pharmacodynamics parameters was not assessed.||||||
1340681|NCT01936363|Secondary|Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409||Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43|As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.||||||
1340683|NCT01936363|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation of Treatment and Death|TEAEs, SAEs and AEs was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse events was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state.|First dose of study drug up to Data Cut-off (19 May 2015)|SAF analysis set included all subjects who received at least one dose of any trial treatment.|||subjects|||Number
1340684|NCT01936363|Secondary|Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28)|EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life.|Baseline up to disease progression or withdrawal, assessed up to Data Cut-off (19 May 2015)|Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued.||||||
1340685|NCT01936363|Secondary|Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|Baseline up to disease progression or withdrawal, assessed up to Data Cut-off (19 May 2015)|Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued.||||||
1340686|NCT01936363|Secondary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.|Time from randomization until death, assessed up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.|||subjects|||Number
1340687|NCT01936363|Secondary|Percentage of Subjects With Disease Control|Disease control as per RECIST v.1.1 was defined as the proportion of subjects with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.|Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.|||percentage of subjects||95% Confidence Interval|Number
1340688|NCT01936363|Secondary|Progression-Free Survival|PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley.|Time from randomization until first observation of progressive disease or death, assessed up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.|||months||95% Confidence Interval|Median
1340689|NCT01936363|Primary|Objective Tumor Response|Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to Data Cut-off (19 May 2015)|ITT analysis set included all subjects who had been randomized.|||percentage of subjects||95% Confidence Interval|Number
1340690|NCT01936181|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 30, Week 54, Week 78|||||||
1340691|NCT01936181|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 30, Week 54, Week 78|||||||
1340692|NCT01936181|Secondary|ACR20||Week 54, Week 78||||percentage of participants|||Number
1340693|NCT01936181|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 30||||percentage of participants|||Number
1340699|NCT01935947|Primary|Percentage of Patients Progression-free at 6 Months From the Time of Randomization|The final analysis will be by Fisher’s Exact test, with percentage of patients who have not progressed as the outcome variable. Using Fisher’s Exact test for analysis with 55 patients per treatment group will provide 88% power to detect an increase from 40% (chemotherapy alone) to 65% (epigenetic therapy followed by chemotherapy) in the number of patients who are progression free at six months.|At 6 months|Data was not collected to assess this outcome measure due to early study termination.||||||
1340700|NCT01935622|Primary|Peak Aerobic Exercise Capacity|Interval change in peak VO2 measured at cardiopulmonary test|14 days||||||Inter-Quartile Range|Median
1340701|NCT01935180|Secondary|Real Time Prediction of Polyp Histology|Difference in recommended surveillance interval between real time polyp diagnosis and pathological diagnosis among patients with at least one diminutive polyp|1 year||||Participants|||Count of Participants
1340702|NCT01935180|Secondary|Ease of Terminal Ileum Intubation|"• Proportion of patients, for whom intubation of the terminal ileum with the colonoscope was rated as easy. Intubation could be rated by the endoscopist as easy, slightly difficult, difficult, or unable to intubate."|1 year||||Participants|||Count of Participants
1340703|NCT01935180|Secondary|Withdrawal Time|• Time taken for the withdrawal of the colonoscope from the cecum to anus among patients, who did not have any polyps.|1 year||||minutes||Inter-Quartile Range|Median
1340704|NCT01935180|Secondary|Quality of Bowel Preparation|Proportion of patients with a bowel preparation that was rated as good or excellent (four point scale that distinguishes the bowel prep as poor, fair, good or excellent).|1 year||||Participants|||Count of Participants
1340705|NCT01935180|Secondary|Advanced Adenoma Detection Rate|Proportion of patients with advanced adenomas|1 year||||Participants|||Count of Participants
1340706|NCT01935180|Secondary|Adenoma Detection Rate|• Adenoma detection rate (ADR), % of patients with at least 1 adenoma|1 year||||Participants|||Count of Participants
1340707|NCT01935180|Primary|Mean Number of Adenomas|Mean number of adenomas per patient in each group.|1 year||||adenoma per patient||Standard Deviation|Mean
1340708|NCT01934894|Secondary|CNS Progression Free Survival|Evaluate the three and six-month CNS progression free survival measured from date of first protocol treatment until tumor progression or death.|every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year|No data was collected for this outcome measure.||||||
1340709|NCT01934894|Secondary|Extra-Cranial Objective Response|The number of participants having Complete and Partial Responses (CR+PR) of extra-cranial lesions assessed per RECIST v1.1 Criteria. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.|every 6 weeks for 8 cycles, then every 9 weeks until treatment discontinuation, up to 1 year||||Participants|||Count of Participants
1340710|NCT01934894|Secondary|CNS Clinical Benefit Response|The number of patients with Complete Response, Partial Response or Stable Disease extending beyond 6 months (CR+PR+SD ≥ 6 months), determined by RECIST v1.1. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion; SD=Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.|every 6 weeks thru cycle 8, and every 3 cycles thereafter until treatment discontinuation, projected 1 year||||Participants|||Count of Participants
1340711|NCT01934894|Primary|Number of Participants Who Experience Dose-Limiting Toxicities (DLTs) as a Measure of Safety|During the safety lead-in, a standard 3+3 dose escalation design is used to determine the maximum tolerated dose (MTD) of cabazitaxel with lapatinib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (21 days) of therapy. If 2 of 6 patients within a dose level experiences a DLT, that dose level would be defined as exceeding the MTD and the previous dose level would be evaluated. DLTs are assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|weekly for 3 weeks||||Participants|||Count of Participants
1340712|NCT01934894|Primary|Maximum Tolerated Dose of Cabazitaxel With Lapatinib|The maximum tolerated dose (MTD) of cabazitaxel and lapatinib will be determined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. A listing of DLTs are reported in the subsequent Primary Outcome Measure.|weekly for 3 weeks|Includes all treated participants, either at Dose Level 1 or Dose Level 2|||mg/m^2 of cabazitaxel + lapatinib|||Number
1340713|NCT01934894|Primary|CNS Objective Response|The number of patients with Complete and Partial Response (CR+PR) of CNS lesions assessed per modified RECIST Criteria for Evaluation of Intracranial Disease. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.|every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year|Includes all treated participants|||Participants|||Count of Participants
1340714|NCT01934790|Post-Hoc|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Worsened to >=3 During the Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
1340715|NCT01934790|Post-Hoc|Number of Participants With Body Weight Changes During the Follow-up Period|Participants were counted once during active follow-up for both increases (using the maximum body weight) and decreases (using the minimum body weight).|Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
1340936|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340716|NCT01934790|Post-Hoc|Number of Participants With Significant Meaningful Changes for Clinical Laboratory NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Toxicity Grades During the Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
1340717|NCT01934790|Post-Hoc|Number of Deaths During Study Treatment or Follow-up Period||Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
1340718|NCT01934790|Post-Hoc|Number of Participants With New Primary Malignancies During Study Treatment or Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
1340719|NCT01934790|Post-Hoc|Number of Participants With New SSE Related AEs During the Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
1340720|NCT01934790|Other Pre-specified|SSE-free Survival|The SSE-FS is the time (days) from the treatment start date to the first SSE on or following the start date or death, whichever occurred first. Participants not experiencing death or an SSE at the database cutoff date for primary completion were censored at the last assessment for SSEs.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340721|NCT01934790|Other Pre-specified|Time to First Symptomatic Skeletal Event (SSE)|Time to first symptomatic skeletal event (SSE) is the time (days) from the treatment start date to the first SSE on or following the start date. Participants not experiencing an SSE at the database cutoff date for primary completion, whether or not surviving, were censored at the last assessment for SSEs.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340722|NCT01934790|Other Pre-specified|Time to Pain Progression|Pain progression was defined in participants evaluable for pain progression at baseline, i.e., participants with a WPS of ≤ 7 at the baseline assessment. Pain assessment occurred daily for 1 week, beginning 1 week prior to each visit and including the day of the visit. An evaluable pain assessment interval required completion of a minimum of 4 out of 7 daily questions. Pain progression was defined as the occurrence of either a pain increase or an increase in pain management with respect to baseline, whichever occurred first.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340723|NCT01934790|Other Pre-specified|Percentage of Participants With Pain Improvement|Pain improvement was defined in evaluable participants (participants with worst pain score [WPS] of 4 at baseline) as a 30% and 2-point decrease in WPS over 2 consecutive measurements conducted at least 4 weeks apart, without an increase in pain management. Pain improvement rate was the number of participants with pain improvement, divided by the total number of evaluable participants WPS was the mean of the WPS in the last 24 hours from the preceding 7 days.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1340724|NCT01934790|Other Pre-specified|Overall Survival|Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340725|NCT01934790|Other Pre-specified|Time to PSA Progression|Prostate specific antigen progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value, and an increase in absolute value of ≥ 2 ng/mL above nadir. The time to PSA progression was defined as the time (days) from the treatment start date to the date of first PSA progression. Participants without PSA progression as of the database cutoff for primary completion, whether or not surviving, were censored at the last PSA laboratory assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340726|NCT01934790|Other Pre-specified|Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as a ≥ 30% reduction of blood PSA level compared with the baseline value, confirmed by a second subsequent PSA value with a ≥ 30% reduction from baseline approximately 4 or more weeks later. Prostate specific antigen response rate was defined as the number of participants with PSA response divided by the total number of participants evaluable for PSA response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1340727|NCT01934790|Other Pre-specified|Percent Change in Total ALP||Baseline and Week 12, Week 24|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
1340728|NCT01934790|Other Pre-specified|Time to Total ALP Progression|Total ALP progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value to at least 1.5 x ULN (upper limit of normal). The time to total ALP progression was defined as the time (days) from the treatment start date to the date of first total ALP progression. Participants not experiencing ALP progression at the database cutoff date, whether or not surviving, were censored at the last ALP laboratory assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340729|NCT01934790|Other Pre-specified|Percentage of Participants With Total Alkaline Phosphatase (ALP) Response|Total alkaline phosphatase (ALP) response was defined as ≥ 30% reduction of the blood total ALP level compared with the baseline values. Total ALP response rate was defined as the number of participants with total ALP response divided by the total number of participants evaluable for total ALP response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1340730|NCT01934790|Other Pre-specified|Time to Radiological Bone Progression|Time to radiological bone progression was defined as the time (days) from the treatment start date to the date of radiological bone progression (according to the adapted PCWG2 [Prostate Cancer Clinical Trials Working Group 2] criteria), as documented by the investigator. Participants not experiencing radiological bone progression at the database cutoff for primary completion were censored at the last radiological bone progression assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340731|NCT01934790|Other Pre-specified|Radiological Progression Free Survival (rPFS)|Radiological progression-free survival (rPFS) was defined as the time from the treatment start date to the date of radiological disease progression or death from any cause (if death occurred before such progression), as documented by the investigator. Participants not experiencing death or radiological disease progression at the database cutoff for primary completion were censored at the last radiological disease progression assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1340732|NCT01934790|Primary|Number of Participants Who Discontinued Radium-223 Dichloride Treatment Due to Treatment Emergent AEs or Death|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
1340733|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Biochemistry Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
1340734|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Hematology Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
1340735|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related SAEs in the Active Follow-up Period|Treatment-related SAE is any SAE that, according to the investigator’s causality assessment, is possibly or probably related to treatment with radium-223 dichloride.|Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
1340736|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related AEs in the Active Follow-up Period|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study.|Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
1340737|NCT01934790|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|TESAE occurred after the start of radium-223 dichloride treatment until 30 days after the last dose and results in death; is life-threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly / birth defect; is another medically important serious event as judged by the investigator; or is an occurrence of leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis, and primary bone cancer or any other new primary malignancy, such as acute myeloid leukemia.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
1340738|NCT01934790|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
1340739|NCT01934582|Secondary|To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing.|AE diaries including 8 therapy-specific terms were collected during both BID and TID dosing to allow for comparison of events from both regimens. The therapy-specific events included: diarrhea, extremity pain, flushing, headache, hypotension, jaw pain, nausea, and vomiting.|The AEs were recorded for up to 50 days.||||percentage of subjects|||Number
1340740|NCT01934582|Secondary|To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose.|The 6-minute walk test (6MWT) was conducted at PK Visits 1 and 2, and was performed between hours 3 to 6 post-morning dose to correlate with the predicted peak plasma concentration of oral treprostinil.|The 6MWT was conducted during BID dosing PK collection (up to 14 days prior to transitioning to TID dosing regimen [PK Visit 1]) and during TID dosing PK collection (up to 35 days after transitioning to TID dosing regimen [PK Visit 2]).||||Meters||Full Range|Mean
1340741|NCT01934582|Primary|To Assess the Pharmacokinetics (AUClast) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)||||h*ng/mL||Full Range|Mean
1340933|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|SLADd is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. SLADd as determined by the echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340742|NCT01934582|Primary|To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)||||ng/mL||Full Range|Mean
1340743|NCT01934582|Primary|To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)||||mg||Full Range|Mean
1340744|NCT01934517|Primary|Overjet|Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor|one year||||mm||95% Confidence Interval|Mean
1340745|NCT01934504|Secondary|Immunosuppression Associated Signature|"Definition of an immune signature associated with maintenance immunosuppression.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to 8 Weeks Post-Immunosuppression Withdrawal|No analyses were performed due to slow enrollment and early study closure.||||||
1340746|NCT01934504|Secondary|Tolerance Signature Versus Clinical Status|"Correlation of possible changes in the tolerance signature with changes in clinical status.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.||||||
1340747|NCT01934504|Secondary|Tolerance Signature Stability|"Measurement of the stability of a tolerance immune signature in patients with AAV over time.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.||||||
1340748|NCT01934504|Primary|Tolerance Biomarker Identification|"Identification of biomarkers associated with clinical tolerance in patients with ANCA-associated vasculitis by comparative immunophenotyping of individual leukocyte subsets from tolerant and non-tolerant patients with AAV.~Due to early study termination, data was not available to evaluate this endpoint."|Difference from baseline to week 26|No analyses were performed due to slow enrollment and early study closure.||||||
1340749|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)|The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each par. using the following classification: Bact. eradication (erad.), presumed bact. erad. and colonization were categorized as erad. Bact. persistence (pers.), presumed bact. pers. and superinfection were categorized as pers. Bact. erad. elimination of the pathogen (path.) after trt; presumed bact. erad.-resolution of signs/symptoms (s/s) after trt; colonization-resolution of s/s but initial path. still recovered from sample; bact. pers.-no improvement in s/s and initial path. was recovered from sample; presumed bact. pers.-no improvement in s/s and isolation of initial path. was impossible/not performed; superinfection-initial path. was eradicated but a new path. was recovered; unable to determine-bact. test could not be performed.|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1|||Participants|||Number
1340750|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8|"The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each path. If the same pathogen was not detected at the EOT, this pathogen was classified as eradication (E). If the same pathogen was detected at the EOT, this pathogen was classified as persistence (P)."|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1|||Participants|||Number
1340751|NCT01934231|Secondary|Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15|The investigator (or sub-investigator) categorized the severity of symptoms such as rhinorrhoea and bad mood/productive cough as none, mild/small amount (M/SA), or moderate or severe (M or S). For the nasal cavity finding of nasal/postnasal discharge (N/PD) the categozation was serous [containing serum]), mucopurulent (MU/SA [containing both mucus and pus]), and moderate or larger amount (M/LA). In cases in which both sides of the nasal cavity were affected and there was no difference in severity between the sides, the right-side results were recorded. If there was a difference in severity, the more severe-side results were recorded.|Baseline (BL), Day 4, Day 8, and Day 15|PP Population|||Participants|||Number
1340752|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) and TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation. In order to be categorized as cure, participants had to meet the criteria for cure at both Day 8 and Day 15."|Day 8 and Day 15|PP Population|||Participants|||Number
1340934|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF as determined by the echo core laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
1340753|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT: Day 8)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 8|PP Population|||Participants|||Number
1340754|NCT01934231|Primary|"Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC: Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 15|Per Protocol (PP) Population: all participants randomized to treatment who received the study drug for at least the first 3 days of study treatment in the Treatment Period and had evaluable data on both Day 8 and Day 15 with treatment compliance between 80% and 100% and no major protocol deviations|||Participants|||Number
1340755|NCT01934218|Post-Hoc|Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26|Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline to week 26 was calculated as baseline minus week 26.|Baseline and Week 26|The post-hoc analysis plan pre-specified that only the change at week 26 in the Gel-One arm is intended to be analyzed.|||mm||95% Confidence Interval|Mean
1340756|NCT01934218|Primary|Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26|Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.|Baseline up to Week26||||mm||95% Confidence Interval|Mean
1340757|NCT01934192|Secondary|Derived Accumulation Ratio (RO) of GSK962040 Post Intolerance|To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed.|Baseline, Day 2, Day 3, Day 4|PK Population. data were not collected.||||||
1340758|NCT01934192|Secondary|Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance|Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time [AUC(0-inf)] was not analyzed.|Day 2 and Day 4|PK Population.|||min*mmol/l||Standard Deviation|Geometric Mean
1340759|NCT01934192|Secondary|Derived Tmax of GSK962040 Post Intolerance|Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n<3.|Day 2 and Day 4|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|||Hr||Full Range|Median
1340760|NCT01934192|Secondary|Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance|Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n < 3.|Day 2 and Day 4|PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|||Log (ng/mL)||95% Confidence Interval|Geometric Mean
1340761|NCT01934192|Secondary|Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance|Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the ‘Safety’ population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|Day 2, Day 3, Day 4, Day 7|PK Population.|||Log (ng/mL)||95% Confidence Interval|Geometric Mean
1340762|NCT01934192|Secondary|Total GRV for 24 hr Period|Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data.|Up to Day 7|ITT (exposed) Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|||mL||Standard Deviation|Mean
1340763|NCT01934192|Secondary|Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes|The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed.|up to 23 days|Enrolled Population|||Participants|||Number
1340764|NCT01934192|Secondary|GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Baseline, Day 2, Day 3, Day 4|ITT (exposed) Population. Only those participants available at the pre-dose visit were analyzed.|||mmol/l||95% Confidence Interval|Geometric Mean
1340888|NCT01932762|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|24 weeks after end of all therapy (Study Week 36)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
1340765|NCT01934192|Secondary|GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Baseline, Day 2, Day 3, Day 4|ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed (represented by n=X in the category titles).|||min*mmol/l||95% Confidence Interval|Geometric Mean
1340766|NCT01934192|Secondary|GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Baseline, Day 2, Day 3, Day 4|ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
1340767|NCT01934192|Secondary|GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Day 2|ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.|||min*ng/mL||95% Confidence Interval|Geometric Mean
1340768|NCT01934192|Secondary|Time to Development of Feeding Intolerance|Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented.|Up to Day 7|ITT (exposed) Population. Two subjects in the Camicinal group and one subject in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.|||Hr||Standard Error|Mean
1340769|NCT01934192|Secondary|Percentage of Participants That Became Intolerant|Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement.|Up to Day 7|ITT (exposed) Population. Two participants in the camicinal group and one participant in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.|||Percentage of participants|||Number
1340770|NCT01934192|Secondary|Derived Tmax of 3-OMG Post Intolerance|Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 – only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG.|At Day 2|PK Population. Data for Tmax was not collected.||||||
1340771|NCT01934192|Secondary|Log Transformed C60 of 3-OMG|Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 – only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|At Day 2|ITT (exposed) Population.|||Log (mmol/L)||95% Confidence Interval|Geometric Mean
1340772|NCT01934192|Secondary|Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG)|Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 – only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|At Day 2|ITT (exposed) Population.|||Log [Min. into mmol/L (min*mmol/l)]||95% Confidence Interval|Geometric Mean
1340773|NCT01934192|Secondary|Log Transformed AUC[0-60] of Acetaminophen|Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 – only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|At Day 2|ITT (exposed) Population.|||Log [min into ng/mL (min*ng/mL)]||95% Confidence Interval|Geometric Mean
1340774|NCT01934192|Secondary|Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance)|Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 – only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles).|At Day 2|ITT (exposed) Population.|||Log [nanogram per milliliter (ng/mL)]||95% Confidence Interval|Geometric Mean
1340900|NCT01932606|Secondary|Change in SVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration||||dyne/s * cm^5||Standard Deviation|Mean
1340775|NCT01934192|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels|Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Picogram (PG)||Standard Deviation|Mean
1340776|NCT01934192|Secondary|Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count|Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Tetra unit per liter (TI/L)||Standard Deviation|Mean
1340777|NCT01934192|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) Levels|Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Femtoliter (fL)||Standard Deviation|Mean
1340778|NCT01934192|Secondary|Change From Baseline in Hematocrit Level|Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Fraction of 1||Standard Deviation|Mean
1340779|NCT01934192|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels|Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||g/L||Standard Deviation|Mean
1340780|NCT01934192|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels|Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Giga unit per liter (gI/L)||Standard Deviation|Mean
1340781|NCT01934192|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values|Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||millimol per liter (mmol/L)||Standard Deviation|Mean
1340782|NCT01934192|Secondary|Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels|Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||micromoles per Liter (µmol/L)||Standard Deviation|Mean
1340800|NCT01933932|Secondary|Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)|Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.|Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) patients who have a baseline ASBI score <= 90|||Months||Inter-Quartile Range|Median
1340783|NCT01934192|Secondary|Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels|Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||International Unit per liter (IU/L)||Standard Deviation|Mean
1340784|NCT01934192|Secondary|Change From Baseline in Albumin and Total Protein Levels|Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Gram per liter (g/L)||Standard Deviation|Mean
1340785|NCT01934192|Secondary|Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values|12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|Up to 23 days|Safety Population.|||Participants|||Number
1340786|NCT01934192|Secondary|Change From Baseline in Heart Rate (HR)|HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||beats per minute (bpm)||Standard Deviation|Mean
1340787|NCT01934192|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the standard deviation (SD) was set to missing.|Up to 23 days|Safety Population.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1340788|NCT01934192|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE.|up to 23 days|Safety Population. Safety Population comprised of all participants who received at least one dose one study treatment.|||Participants|||Number
1340789|NCT01934192|Secondary|Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance|Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data.|Up to Day 7|ITT (exposed) Population|||Days||Inter-Quartile Range|Median
1340790|NCT01934192|Secondary|Average Percentage Goal Protein Delivered Prior to Development of Intolerance|The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.|Up to Day 7|ITT (exposed) Population|||Percentage of goal protein||95% Confidence Interval|Mean
1340791|NCT01934192|Secondary|Average Percentage Goal Calories Delivered Prior to Development of Intolerance|The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.|Up to Day 7|ITT (exposed) Population|||Percentage of goal calories||95% Confidence Interval|Mean
1342407|NCT01914757|Secondary|Number of Patients With >=1 Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
1340792|NCT01934192|Primary|Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population|The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.|Up to Day 7|Per Protocol (PP) Population. PP Population comprised of all randomized participants who receive at least two doses of study treatment and have at least two days of evaluable nutritional data and also comply with the protocol.|||Percentage of goal volume||95% Confidence Interval|Mean
1340793|NCT01934192|Primary|Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population|The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.|Up to Day 7|Intension To Treat [ITT (exposed)] Population. ITT (exposed) Population comprised of all randomized participants who received at least of one dose of study treatment.|||Percentage of goal volume||95% Confidence Interval|Mean
1340794|NCT01934010|Secondary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 168 (TV7) to Day 252 (FUV9) of cycle 3|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
1340795|NCT01934010|Secondary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 84 (TV4) to Day 168 (FUV6) of cycle 2|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
1340796|NCT01934010|Secondary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 1 (TV1) to Day 84 (FUV3) of cycle 1|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
1340797|NCT01934010|Primary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 168 (TV7) up to Day 203 (FUV8) of cycle 3||||Number subject affected|||Number
1340798|NCT01934010|Primary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 84 (TV4) to Day 119 (FUV5) of cycle 2|"The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.~Subjects from Cycle 1 did not participate in Cycle 2 and 3 and are therefore zero."|||Number subject affected|||Number
1340799|NCT01934010|Primary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 1 (TV1) to Day 35 (FUV2) of cycle 1|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
1340901|NCT01932606|Secondary|Change in PA Compliance After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration||||ml/mm Hg||Standard Deviation|Mean
1340801|NCT01933932|Secondary|Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)|The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.|Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) patients who have a baseline ASBI score >= 10|||Participants|||Count of Participants
1340802|NCT01933932|Secondary|Duration of Response (DoR)|Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.|||Days||95% Confidence Interval|Median
1340803|NCT01933932|Secondary|Objective Response Rate (ORR)|ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.|||Participants|||Count of Participants
1340804|NCT01933932|Secondary|Overall Survival (OS)|Overall Survival is defined as the time from the date of randomisation until death due to any cause.|Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI|Full analysis set (FAS) population comprised of all randomised patients.|||Months||Inter-Quartile Range|Median
1340805|NCT01933932|Primary|Progression-Free Survival (PFS)|Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.|||Months||Inter-Quartile Range|Median
1340806|NCT01933919|Secondary|Number of Participants With Adverse Events During the Second Phase|"An adverse event was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event.~The investigator used the following definitions to rate the severity of each adverse event:~Mild: The adverse event was transient and easily tolerated by the participant;~Moderate: The adverse event caused the participant discomfort and interrupted usual activities.~Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome."|From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 60 weeks in the second phase of the study.|Participants who received the study drug at least once in the second phase.|||participants|||Number
1340807|NCT01933919|Secondary|Number of Participants With Adverse Events During the First Phase|"An adverse event (AE) was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event.~The investigator used the following definitions to rate the severity of each adverse event:~Mild: The adverse event was transient and easily tolerated by the participant;~Moderate: The adverse event caused the participant discomfort and interrupted usual activities.~Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome."|From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 18 weeks in the first phase.|Participants who received the study drug at least once in the first phase|||participants|||Number
1340808|NCT01933919|Secondary|Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase|"The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication in the 2nd phase:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Worse~Very much worse~Much improved includes CGI score categories 'very much improved' and 'much improved'."|Baseline of the 2nd phase and weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Full analysis set for the 2nd phase; last observation carried forward imputation was used for the last post-baseline visit assessment.|||percentage of participants|||Number
1340809|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase|"The Japanese version of the Children’s Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.~Baseline for the 2nd phase was the first visit of the 2nd phase after completion of the tapering period in the first phase and prior to study drug administration in the 2nd phase."|Baseline of the 2nd phase and weeks 2, 8, 16, 28, 40, and 52 of the 2nd phase|The full analysis set (FAS) for the 2nd phase (FAS2) included participants who received at least one dose of study drug, and had a baseline and at last one post-baseline measurement for efficacy after week 1 in the 2nd phase. Last observation carried forward imputation was used for the last post-baseline visit assessment.|||units on a scale||Standard Deviation|Mean
1340810|NCT01933919|Secondary|Percentage of Participants With a ≥ 35% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase|The Japanese version of the Children’s Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the first phase; last observation carried forward imputation was used.|||percentage of participants|||Number
1340811|NCT01933919|Secondary|Percentage of Participants With a ≥ 25% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase|The Japanese version of the Children’s Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the first phase; last observation carried forward imputation was used.|||percentage of participants|||Number
1340812|NCT01933919|Secondary|Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase|"The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Worse~Very much worse~Much improved includes CGI score categories ‘very much improved’ and ‘much improved’."|Weeks 1, 2, 3, 4, 5, 6, 8, and 10|Full analysis set for the first phase; participants with available data at each time point. Last observation carried forward imputation was used for the last post-baseline visit assessment.|||percentage of participants|||Number
1340813|NCT01933919|Secondary|JCY-BOCS 10-item Total Score at Each Visit During the First Phase|The Japanese version of the Children’s Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and weeks 2, 4, 6, 8 and 10|Full analysis set for the first phase; participants with available data at each time point. Last observation carried forward imputation was used for the last post-baseline visit assessment.|||units on a scale||Standard Deviation|Mean
1340814|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase|The Japanese version of the Children’s Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and weeks 2, 4, 6, 8 and 10|Full analysis set for the 1st phase; participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1340815|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the 1st phase; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
1340816|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the first phase; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
1340817|NCT01933919|Primary|Mean Change From Baseline in the Japanese Children’s Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase|The Japanese version of the Children’s Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the 1st phase; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
1340818|NCT01933880|Secondary|Number of Participants Compliant With Treatment|Number of Participants who are Compliant with Treatment will be accessed. Less than 80 percent and more than 120 percent compliance signifies bad compliance, 80 to 120 percent compliance signifies good compliance . The compliance was calculated by the percentage of dose (actual dose multiplied by 100/theoretical dose).The theoretical dose means the dose prescribed by the Investigator.|End of Week 12|"FAS population for OROS-MPH Group. Here N signifies participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||participants|||Number
1340819|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12|Remission rate in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale.|Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1342899|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mmol/L||Standard Deviation|Mean
1340820|NCT01933880|Secondary|Change From Baseline in Completion Time of Stroop Color-word Test at Week 12|Completion time of stroop color-word test in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test will be scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median time of the naming time in the Stroop color word naming test will be accessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at each time point for each specific arm."|||Seconds||Standard Deviation|Mean
1340821|NCT01933880|Secondary|Change From Baseline in Total Scores of Digit Span Test at Week 12|The digit span test total score will be accessed in different dosage groups to evaluate the relationship between therapeutic effect and dosage. The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is16, and the maximum subscore in the Digits Backward is 14, for a total score of 30. A higher score was indicative of better recall and attention.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."|||Scores on a scale||Standard Deviation|Mean
1340822|NCT01933880|Secondary|Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12|IOWA conners behavior rating scale score in different dosage groups will be accessed to evaluate relationship between therapeutic effect and dosage. IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."|||Scores on a scale||Standard Deviation|Mean
1340823|NCT01933880|Secondary|Number of Participants With Clinical Global Impression - CGI Scale Score|CGI is an overall rating scale. Clinical Global Impression (Improvement of Diseases) is divided into seven grades: 1=very significant improvement, 24=significant improvement or advanced, 3=improvement or slightly advanced, 4=no change, 5=slight aggravation, 6=significant aggravation, and 7=very significant aggravation or seriously aggravated. Number of participants in each category of grade were assessed.|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test|||Participants|||Number
1340824|NCT01933880|Secondary|Academic Achievement|Mathematics and language scores will be obtained from their corresponding examinations at school. Scores ranges from 0-100 respectively. Mathematics and language would be summarized separately.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||scores on a scale||Standard Deviation|Mean
1340825|NCT01933880|Secondary|Coding Test|The coding Test is a common test indicator for perceptual speed. The test presents a series of corresponding relationship between graphics and symbols to the participant, and then participants will be required to fill out the appropriate symbol following single symbol in the test part. The test is limited within 150 seconds and evaluated the number of symbols been replaced correctly by the participants.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Number of symbols correctly replaced||Standard Deviation|Mean
1340826|NCT01933880|Secondary|WCST: Learning to Learn (L-C)|"WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. Learning to learn indicator was a measure of decrement in the number of responses needed to achieve each successive category. The raw score ranged from 0 to 100. The high, negative value suggests the participants could not effectively learn the task presented by the WCST. Only calculated in those completed 3 or more categories and not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case)."|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of responses||Standard Deviation|Mean
1340930|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|SLADs is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole. SLADs as determined by the echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340827|NCT01933880|Secondary|WCST: Failure to Maintain Set (Fm)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The frequency (number of times) of responses completed with 5 to 9 continuous correct was evaluated. Ranges from 0 to 26 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of times||Standard Deviation|Mean
1340828|NCT01933880|Secondary|WCST: Non-Persistent Error Responses (nRpe)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Non perseverative error responses are the errors remaining after subtracting persistent errors from total errors. Ranges from 0 to 128 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of non-persistent error responses||Standard Deviation|Mean
1340829|NCT01933880|Secondary|WCST: Percentage of Perseverative Error Responses (Rpe%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative (pvt) errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of persistent errors out of total number of responses was evaluated. Ranges from 0 to 100%, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Percentage of pvt error responses||Standard Deviation|Mean
1340830|NCT01933880|Secondary|WCST: Perseverative Error Responses (Rpe)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Perseverative error responses are the number of responses which applied continuity principle for matching answers and also had the wrong answer was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of perseverative error responses||Standard Deviation|Mean
1340831|NCT01933880|Secondary|WCST: Perseverative Responses (Rp)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of perseverative responses were the responses which applied continuity principle for matching answers was evaluated. Ranges from 0 to 100, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of perseverative responses||Standard Deviation|Mean
1340855|NCT01933672|Secondary|Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||participants|||Number
1348945|NCT01813474|Secondary|Cmax Following Single Dosing||Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose|Dose escalation part only|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1340832|NCT01933880|Secondary|WCST: Percentage of Conceptual Level Responses (Rf%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of the responses completed with 3-10 continuous correct during the entire measuring process was evaluated. Ranges from 0 to 100%, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||percentage of conceptual level responses||Standard Deviation|Mean
1340833|NCT01933880|Secondary|WCST: First Response (Rf)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of responses needed to complete the first color classification was evaluated. Ranges from 9 to 128, the lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of first responses||Standard Deviation|Mean
1340834|NCT01933880|Secondary|WCST: Percentage of Correct Responses (Rc%)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0 to 100 percent (%), the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Percentage of correct responses||Standard Deviation|Mean
1340835|NCT01933880|Secondary|WCST: Error Responses (Re)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of error responses which did not comply with the response principles was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of error responses||Standard Deviation|Mean
1340836|NCT01933880|Secondary|WCST: Correct Responses (Rc)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The number of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0-116, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of correct responses||Standard Deviation|Mean
1340844|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 2|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
1340886|NCT01932970|Secondary|Percent Change From Baseline in Parathyroid Hormone During the Treatment Period||Baseline and weeks 2, 3 and 4|Full analysis set with available data at each time point|||percent change||Standard Error|Mean
1340837|NCT01933880|Secondary|WCST: Completed Categories (Cc)|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. In completed categoriies, number of categories completed out of 6 sorting categories after the test was evaluated. Ranges from 0 to 6. The more the number of categories completed the better is the response.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Nunber of Categories Completed||Standard Deviation|Mean
1340838|NCT01933880|Secondary|Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination|WCST is used to evaluate participants’ abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants’ cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. During number of trials administered or administered responses, participants were administered 128 cards and asked to sort the cards until all the 6 sorting categories was completed. Response number used to complete all 6 categories ranges from 50 to 128, lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Responses||Standard Deviation|Mean
1340839|NCT01933880|Secondary|Stroop Color Word Naming Test|This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test is scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median naming time in the Stroop color word naming test will be assessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|FAS for OROS-MPH Group included participants who took at least 1 study drug therapy and had at least 1 efficacy evaluation. FAS for normal group included participants who had baseline assessment scale evaluation and had at least 1 endpoint assessment scale evaluation. ‘n’=participants who were evaluable at each specific time point for each arm.|||Seconds||Standard Deviation|Mean
1340840|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.|Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test.|||Percentage of Participants|||Number
1340841|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 12|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
1340842|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 7|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
1340843|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 3|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
1340845|NCT01933880|Primary|Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 1|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
1340846|NCT01933880|Primary|Change From Baseline in Digit Span Test Total Score at Week 12|The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention.|Baseline and Week 12|Full Analysis Set (FAS) population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. FAS for normal group included all participants who received baseline assessment scale evaluation and had at least one endpoint assessment scale evaluation.|||Scores on a scale||Standard Deviation|Mean
1340847|NCT01933776|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1340848|NCT01933776|Primary|Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1340849|NCT01933672|Secondary|Plasma PF-04937319 Time for Cmax (Tmax) on Day 14|Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||hour||Full Range|Median
1340850|NCT01933672|Secondary|Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14|Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1340851|NCT01933672|Secondary|Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14|Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1340852|NCT01933672|Secondary|Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14|Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1340853|NCT01933672|Secondary|Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1340854|NCT01933672|Secondary|Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Two (2) PK parameters specified in the protocol and SAP were not reported: AUClast was not reported since it was the same as AUC24 in this study, and apparent volume of distribution (Vz/F) was not reported since the log-linear terminal phase of the concentration-time profiles was not consistently well characterized in the 24-hour sampling period.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1340856|NCT01933672|Secondary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: sitting systolic BP (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing SBP less than (<) 90 mm Hg; sitting diastolic BP (DBP) >=20 mm Hg change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing DBP <50 mm Hg; 2), pulse rate (supine): <40 or greater than (>) 120 beats per minute (bpm).|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||participants|||Number
1340857|NCT01933672|Secondary|Change From Baseline in Body Weight (kg)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||kg||Standard Error|Mean
1340858|NCT01933672|Secondary|Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||participants|||Number
1340859|NCT01933672|Secondary|Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment. HAEs meeting protocol definition were summarized descriptively by treatment.|||participants|||Number
1340860|NCT01933672|Secondary|Change From Baseline in Pre-meal Insulin on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for insulin at 0, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.|||micro international unit/milliliter||Standard Error|Least Squares Mean
1340861|NCT01933672|Secondary|Change From Baseline in Pre-meal C-Peptide on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for C-peptide at the pre-specified nominal timepoints at predose, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.|||nanograms/milliliter (ng/mL)||Standard Error|Least Squares Mean
1340862|NCT01933672|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections at the pre-specified nominal timepoints of each period: predose (ie, time “0”), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours on Day 0 (baseline) and Day 14; and predose on Days 1 and 15.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.|||mg/dL||Standard Error|Least Squares Mean
1340863|NCT01933672|Primary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14|Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.|Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement at both baseline and on Day 14.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
1340864|NCT01933425|Secondary|Surgical Conditions During Suturing of the Abdominal Fascia|Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)|1 hour|Evaluation of surgical conditions was compared using Mann–Whitney U-test.|||participants|||Number
1340865|NCT01933425|Secondary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test|||centimeters||95% Confidence Interval|Median
1340866|NCT01933425|Primary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test.|||centimeters||Full Range|Median
1340867|NCT01933399|Secondary|Change Score in the Patient Specific Activity Scale|Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.|Baseline and 2-weeks||||units on a scale||95% Confidence Interval|Mean
1340868|NCT01933399|Primary|Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)|Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.|Baseline and 2 weeks||||units on a scale||95% Confidence Interval|Mean
1340887|NCT01932970|Primary|Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period||4 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1349017|NCT01811680|Primary|10 Meter Walk Test|Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)|8 weeks||||m/s||Standard Deviation|Mean
1340869|NCT01933334|Secondary|University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores|UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant’s assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health.|Baseline, Weeks 4, 8, 12, and 16|Safety population. n = number of participants analyzed at specified time.|||units on a scale||Standard Deviation|Mean
1340870|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.|||percentage of participants|||Number
1340871|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.|||percentage of participants|||Number
1340872|NCT01933243|Other Pre-specified|Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use|"At baseline, 6 weeks, and 12 weeks, study participants were asked to collect salivary samples 5 times over a 24 hour period. In addition, participants were asked to wear a 24 hour heart monitor during this same 24 hour interval. Compliance wtth completion of these physiological measures was assessed as follows:~For saliva collection, compliance was assessed by return of 5 full vials of saliva with record of time collected.~For 24 hour heart rate monitor, compliance was assessed by return of monitor with then downloading of data to confirm that the participant wore the device during the specified time interval."|Baseline, 6 weeks, and 12 weeks|All participants completing at least a baseline visit.|||Participants|||Count of Participants
1340873|NCT01933243|Secondary|Beck Anxiety Inventory—Trait (BAIT)|The BAIT is a 21-item self-report measure of anxiety severity rated on a 4-point Likert scale (0= rarely or never; 3= almost always). It has shown acceptable reliability and validity in an adolescent psychiatric inpatient population. BAIT scores over 26 indicate severe anxiety, scores 16-25 indicate moderate anxiety, scores 8-15 indicate mild anxiety, and scores 0-7 indicate a minimal level of anxiety. We chose to measure trait anxiety to examine beyond meal-related (state) anxiety.|Baseline, 6 weeks, and 12 weeks|All participants who completed a baseline study visit|||Score on a scale||Standard Error|Mean
1340874|NCT01933243|Primary|Medication Side Effects Score|At 6 and 12 weeks, medication tolerability was assessed via self-report of nine potential side effects (e.g. diarrhea, burping). Participants were asked whether they experienced these side effects “never, rarely, occasionally, frequently, or very frequently.” Individual responses were assigned a numeric equivalent from 0 to 4, and summed for a total side effect score ranging from 0 to 36. Higher scores indicated greater frequency of side effects and lower medication tolerability.|6 and12 weeks|Participants who completed at least a baseline study visit.|||Score on a scale||Standard Error|Mean
1340875|NCT01933230|Primary|To Determine if Neck Cooling Affects Brain Temperature.||During the 2 hours of neck cooling|||||||
1340876|NCT01933230|Primary|To Determine if Neck Cooling Affects Intracranial Pressure||During 2 hours of neck cooling|||||||
1340877|NCT01933230|Primary|Temperature Reduction by 1 Degree Per Hour in the ICU Setting.|Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.|During the 2 hours of neck cooling||||degrees celsius||Standard Deviation|Mean
1340878|NCT01933048|Other Pre-specified|Feasibility of Self-administration Following Vaccine Administration||28+/- 7 days post-vaccination|Numbers include participants randomized to the SA group only.|||participants|||Number
1340879|NCT01933048|Other Pre-specified|Feasibility of Self-administration Prior to Vaccine Administration||28+/- 7 days post-vaccination||||participants|||Number
1340880|NCT01933048|Secondary|Difference and Proportion in Seroconversion of Subjects||28+/- 7 days post-vaccination||||participants|||Number
1340881|NCT01933048|Secondary|Difference and Proportion in Seroresponse of Subjects||28+/- 7 days post-vaccination||||participants|||Number
1340882|NCT01933048|Primary|Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects||28+/- 7 days post-vaccination||||titer ratio||95% Confidence Interval|Geometric Mean
1340883|NCT01932970|Other Pre-specified|Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period|Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.|From the first dose of study drug up to 30 days after the last dose; 8 weeks|Participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
1340884|NCT01932970|Other Pre-specified|Number of Participants With Adverse Events||From the first dose of study drug up to 30 days after the last dose; 8 weeks|All participants who received at least one dose of study drug|||participants|||Number
1340885|NCT01932970|Secondary|Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period||4 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1340889|NCT01932762|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|4 weeks after end of all therapy (Study Week 16)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
1340890|NCT01932762|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
1340891|NCT01932762|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
1340892|NCT01932762|Secondary|Mean Time to First Achievement of Undetectable HCV RNA During Treatment|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).|From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)|FAS; all randomized participants who received ≥1 dose of study therapy. Participants in the FAS not achieving TND were censored from the analysis.|||days||Standard Error|Mean
1340893|NCT01932762|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related.|Treatment period plus the first 14 days of follow-up (up to 14 weeks)|All-Subjects-As-Treated (ASAT) Population; all randomized participants who received ≥ 1 dose of study therapy. The percentage of participants with specific AEs and accompanying 95% CI were reported for each treatment arm.|||percentage of participants||95% Confidence Interval|Number
1340894|NCT01932762|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)|SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.|12 weeks after end of all therapy (Study Week 24)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
1340895|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration||||ml||Standard Deviation|Mean
1340896|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration||||L/min||Standard Deviation|Mean
1340897|NCT01932606|Secondary|Change in Arteriovenous Oxygen Difference After Study Drug (Exercise)|Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration||||ml/dl||Standard Deviation|Mean
1340898|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||ml/min||Standard Deviation|Mean
1340899|NCT01932606|Secondary|Change in LVSW After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration||||g/beat||Standard Deviation|Mean
1340902|NCT01932606|Secondary|Change in PVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration||||mm Hg/L/min||Standard Deviation|Mean
1340903|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
1340904|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||beats/minute||Standard Deviation|Mean
1340905|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
1340906|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration||||ml||Standard Deviation|Mean
1340907|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) The volume of blood pumped per minute by each ventricle of the heart. Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration||||L/min||Standard Deviation|Mean
1340908|NCT01932606|Secondary|Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration||||ml/dl||Standard Deviation|Mean
1340909|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||ml/min||Standard Deviation|Mean
1340910|NCT01932606|Secondary|Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration||||g/beat||Standard Deviation|Mean
1340911|NCT01932606|Secondary|Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration||||dyne/s * cm^5||Standard Deviation|Mean
1340912|NCT01932606|Secondary|Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration||||ml/mm Hg||Standard Deviation|Mean
1340913|NCT01932606|Secondary|Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration||||mm Hg/L/min||Standard Deviation|Mean
1340914|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
1340915|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||beats/minute||Standard Deviation|Mean
1340916|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
1340917|NCT01932606|Primary|Exercise Pulmonary Capillary Wedge Pressure (PCWP)|Pulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.|during repeat exercise run, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
1340918|NCT01932164|Primary|Quality of Bone Regeneration|The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.|Three months after the graft||||percentage of bone filling||80% Confidence Interval|Mean
1340931|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|SLADd is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. SLADd as determined by the echo core laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340919|NCT01932164|Primary|Amount of New Bone Mass Formed|The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.|6 months from surgical procedure for alveolar grafting;|3 females and 2 males with cleft lip and palate|||percentage of bone formation||95% Confidence Interval|Mean
1340920|NCT01932112|Secondary|Atrial Fibrillation Recurrence|At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation)|between 0 and 12 months|||||||
1340921|NCT01932112|Primary|Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion|After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.|5 minutes after IV adenosine||||participants|||Number
1340922|NCT01932060|Secondary|Hemoglobin Indices After Cesarean Delivery|Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery|24 hr after cesarean delivery||||g/dl||Inter-Quartile Range|Median
1340923|NCT01932060|Primary|Total Estimated Blood Loss|Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).|immediately at end of surgery||||ml||Inter-Quartile Range|Median
1340924|NCT01931956|Other Pre-specified|Change in 6-Minute Walk Test (6MWT)|Defined as a cardiopulmonary function test that measures a patient’s exercise capacity by the distance he or she can walk in six minutes.|At Baseline and 12 months|"EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 1 year were not available for EU arm.~In CU arm,18 patients died prior to 1 year, 2 withdrew consent, 3 missed visit and 11 patients did not complete the 30-day 6MWT."|||Meters||Standard Deviation|Mean
1340925|NCT01931956|Other Pre-specified|Change in 6-Minute Walk Test (6MWT)|Defined as a cardiopulmonary function test that measures a patient’s exercise capacity by the distance he or she can walk in six minutes.|At Baseline and 30 Days|"EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore,paired data at 30 days were not available for EU arm.~In CU arm,36 participants were analyzed as 4 patients died prior to 30 days,2 withdrew consent and 17 patients did not complete the 30-day 6MWT."|||Meters||Standard Deviation|Mean
1340926|NCT01931956|Other Pre-specified|36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:~Physical functioning~Role limitations due to physical or~Emotional health~Bodily pain~General health perceptions~Vitality~Social functioning~General mental health~Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|12 months|"EU arm participants were not analyzed due to the serious/life-threatening conditions, QOL data was not collected on all patients at baseline. Therefore, paired data at 1 year were not available for EU arm.~In CU arm, 18 patients died prior to 1 year, 2 withdrew consent, 3 missed visit and SF-36 QOL instrument was not administered in 4 patients."|||Scores on a scale||Standard Deviation|Mean
1340927|NCT01931956|Other Pre-specified|36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:~Physical functioning~Role limitations due to physical or~Emotional health~Bodily pain~General health perceptions~Vitality~Social functioning~General mental health~Responses to each of the SF-36 items are scored and expressed as a score on a 0–100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|30 days|"EU arm participants were not analyzed due to the serious/life-threatening conditions,SF-36 QOL data was not collected on all patients at baseline. Therefore, paired data at 30 days were not available for EU arm.~In CU arm, 4 patients died prior to 30 days, 2 withdrew consent and SF-36 QOL instrument was not administered in 9 patients."|||Scores on a scale||Standard Deviation|Mean
1340928|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|SLADs is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole. SLADs as determined by the echo core laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340929|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|SLADs is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole. SLADs as determined by the echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340932|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|SLADd is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. SLADd as determined by the echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340937|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the echo core laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340938|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340939|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular internal dimension systole (LVIDs) as determined by the echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340940|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the echo core laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340941|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340942|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Left Ventricular internal dimension diastole (LVIDd) as determined by the echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
1340943|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Left ventricular end-systolic volume (LVESV) is determined by the echo core laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1340944|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Left ventricular end-systolic volume (LVESV) is determined by the echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1340945|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Left ventricular end-systolic volume (LVESV) is determined by the echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1340946|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Left ventricular end-diastolic volume (LVEDV) is determined by the echo core laboratory.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1340947|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Left ventricular end-diastolic volume (LVEDV) is determined by the echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1340948|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Left ventricular end-diastolic volume (LVEDV) is determined by the echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
1340949|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|The 4-year visit was optional and no data were collected at this time point.||||||
1340950|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340951|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340969|NCT01931956|Secondary|Device Time|Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.|On the day of index procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||minutes||Standard Deviation|Mean
1340952|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|"CU Arm:~Of total 59 subjects, NYHA Functional Class assessment was missing in 24 patients due to death (n=18), withdrawal (n=2), missed 1-year visit (n=3), or because it was not performed (n=1).~EU Arm:~Of total 7 subjects, NYHA Functional Class assessment was missing in 6 patients due to death (n=5) or missed 1-year visit (n=1)."|||Participants|||Count of Participants
1340953|NCT01931956|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|"CU Arm:~Of total 59 subjects, NYHA Functional Class assessment was missing in 9 patients due to death (n=4), missed 30-day visit (n=2), or because it was not performed (n=3).~EU Arm:~Of total 7 subjects, NYHA Functional Class assessment was missing in 4 patients due to death (n=3) or because it was not performed (n=1)."|||Participants|||Count of Participants
1340954|NCT01931956|Secondary|Number of Participants With Second Intervention to Place an Additional Mitraclip Device.|If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.|139 days post the index procedure||||Participants|||Count of Participants
1340955|NCT01931956|Secondary|Number of Participants With MR Severity|Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|4 years|The 4-year visit was optional and no data were collected at this time point.||||||
1340956|NCT01931956|Secondary|Number of Participants With MR Severity|Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340957|NCT01931956|Secondary|Number of Participants With MR Severity|Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340958|NCT01931956|Secondary|Number of Participants With MR Severity|Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340959|NCT01931956|Secondary|Number of Participants With Mitral Regurgitation (MR) Severity|Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340960|NCT01931956|Secondary|Number of Participants With Mitral Stenosis|Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm^2 as assessed by the Echocardiography Core Laboratory (ECL).|0 to 5 years||||Participants|||Count of Participants
1340961|NCT01931956|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)||0 to 5 years||||Participants|||Count of Participants
1340962|NCT01931956|Secondary|Number of Participants With Death||12 months visit window (410 days)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1340963|NCT01931956|Secondary|Number of Participants With Hospital Re-admissions|Defined as re-admission of patients to the hospital following discharge from the Clip procedure.|30 days||||Participants|||Count of Participants
1340964|NCT01931956|Secondary|Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility||At discharge (an average of ≤ 12.3 days post-index procedure)||||Participants|||Count of Participants
1340965|NCT01931956|Secondary|Post-Procedure Length of Hospital Stay|Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.|30 days||||Days||Standard Deviation|Mean
1340966|NCT01931956|Secondary|Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration|Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.|30 days||||Hours||Standard Deviation|Mean
1340967|NCT01931956|Secondary|Number of Participants With MitraClip Devices Implanted|The distribution of number of MitraClip devices implanted in patients.|On the day of index procedure||||Participants|||Count of Participants
1340968|NCT01931956|Secondary|Fluoroscopy Duration|Mean fluoroscopy duration during the MitraClip procedure.|On the day of index procedure||||minutes||Standard Deviation|Mean
1340970|NCT01931956|Secondary|Procedure Time|The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.|On the day of index procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||minutes||Standard Deviation|Mean
1340971|NCT01931956|Secondary|Number of Participants With Clip Implant Rate|Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.|On the day of index procedure (≤1 day)||||Participants|||Count of Participants
1340972|NCT01931956|Secondary|Number of Participants With Clinical Durability|Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.|12 months||||Participants|||Count of Participants
1340973|NCT01931956|Secondary|Number of Participants With Procedural Success|Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.|30 days||||Participants|||Count of Participants
1340974|NCT01931956|Secondary|Number of Participants With Acute Procedural Success|Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.|At discharge (an average of ≤ 12.3 days post-index procedure)||||Participants|||Count of Participants
1340975|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|4 years|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 24 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm."|||Participants|||Count of Participants
1340976|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|3 years|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm."|||Participants|||Count of Participants
1340977|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|2 years|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm."|||Participants|||Count of Participants
1340978|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|12 Months|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm."|||Participants|||Count of Participants
1340979|NCT01931956|Secondary|Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|30 days|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm."|||Participants|||Count of Participants
1340980|NCT01931956|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD)|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|12 months||||Participants|||Count of Participants
1340981|NCT01931956|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD)|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|30 days||||Participants|||Count of Participants
1340982|NCT01931956|Secondary|Number of Participants With Serious Adverse Events|The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.|12 months||||Participants|||Count of Participants
1340983|NCT01931956|Secondary|Number of Participants With Serious Adverse Events|The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.|30 days||||participants|||Number
1340984|NCT01931956|Primary|Number of Participants With 12-Month Efficacy|Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).|12 months|Of total 59 participants in CU arm, analysis population included 52 participants due to withdrawals (n=2), patients with missing/non-readable echo core lab MR severity assessment at 1 year (n=2), and patients with missed 1 year visit (n=3). Similarly, in EU arm 6 subjects were analyzed as 1 patient missed-visit at 1 year.|||Participants|||Count of Participants
1340985|NCT01931956|Primary|Number of Participants With Major Adverse Events|A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.|12 months||||Participants|||Count of Participants
1340986|NCT01931956|Primary|Number of Participants With Major Adverse Events|A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.|30 days||||Participants|||Count of Participants
1340987|NCT01931878|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment."|6 weeks||||participants|||Number
1340988|NCT01931878|Other Pre-specified|Patients With Pain on Visual Analog Scale <4|The Visual Analog Scale (VAS) consists of a line which represents the level of pain in 10 cms. The subject is required to make this line to show where your pain level is on this line (for example, at the 7cm mark). A higher score is associated with a higher level of pain. Number of patients showing a pain score of <4.|6 weeks||||participants|||Number
1340989|NCT01931878|Primary|Mean Total Restless Leg Syndrome Rating Scale Score|The Restless Legs Syndrome Rating Scale uses 10 questions, each scored 0-4, with higher scores representing more severe symptoms. Score ranges from 1-40. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40)|6 weeks|Total RLS scale score was compared between incoA injections and and saline group injections.|||units on a scale||Standard Deviation|Mean
1340990|NCT01931865|Other Pre-specified|Patients Improved in Patient Global Impression of Change (PGIC) Scale|The Patient Global Impression of Change questionaire asks patient level of satisfaction with current treatment (from very unsatisfactory to very satisfactory).|12 weeks|Advanced cancer patients|||participants|||Number
1340991|NCT01931865|Secondary|Patients Who Show Improvement in American Pain Association Questionnaire|This quality of life scale consists of 10 questions regarding how pain affects your quality of life.|12 weeks|Advanced cancer patients|||participants|||Number
1340992|NCT01931865|Primary|Number of Participants With a Significant Reduction in Pain|visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale.|12 weeks||||participants|||Number
1340993|NCT01931839|Secondary|Part A Observation Cohort: Number of Participants With Serious Adverse Events (SAEs)|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|up to 2 years|Safety Set (study 105) included all participants who were enrolled in Part A Observation Cohort.|||participants|||Number
1340994|NCT01931839|Secondary|Part B Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of participants with at least 5% relative change in percent predicted FEV1 from Baseline were reported. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7. As per planned analysis, endpoint evaluation included subjects from the parent study VX09-809-102 as well.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS (Study 102) was used for Arm 6 and 7, and included all participants randomized in the cohort 4 of study 102 and dosed.|||percentage of participants||95% Confidence Interval|Number
1341020|NCT01931527|Secondary|AFTER Rasburicase Plasma TRAP|Total Radical-Trapping Antioxidant Potential|12 hours after reducing uric acid|AFTER rasburicase plasma Total Radical-Trapping Antioxidant Potential (TRAP) was only measured in the subjects with high uric acid|||mmol · Lˉ¹||Standard Error|Mean
1341021|NCT01931527|Secondary|Baseline Plasma TRAP|Total Radical-Trapping Antioxidant Potential|Before reducing uric acid||||mmol · Lˉ¹||Standard Error|Mean
1341022|NCT01931527|Secondary|AFTER Rasburicase Carbonylated Protein Ratio|Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle|12 hours after reducing uric acid|Analysis only completed on subjects in the High Uric Acid group|||Ratio||Standard Error|Mean
1340995|NCT01931839|Secondary|Part A Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of participants with at least 5% and 10% relative change in percent predicted FEV1 from baseline were reported. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60, 72, 84, 96 (Study 105)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.|||percentage of participants||95% Confidence Interval|Number
1340996|NCT01931839|Secondary|Part A Treatment Cohort: Percentage of Participants With at Least 1 Pulmonary Exacerbation|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Analysis was performed for the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.|||percentage of participants||95% Confidence Interval|Number
1340997|NCT01931839|Secondary|Part A Treatment Cohort: Time-to-First Pulmonary Exacerbation|Time-to-first pulmonary exacerbation was analyzed using the Kaplan-Meier estimates. Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Analysis was performed for the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.|||days||Inter-Quartile Range|Median
1340998|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||kg||Standard Deviation|Mean
1340999|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||kilograms (kg)||Standard Deviation|Mean
1341000|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in BMI Z-score at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||z-score||Standard Error|Least Squares Mean
1341001|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102 Study), Day 15, Week 8, 16, 24, 48, 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1341023|NCT01931527|Secondary|Baseline Carbonylated Protein Ratio|Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle|Before reducing uric acid||||Ratio||Standard Error|Mean
1352111|NCT01769443|Secondary|Incidence of Serious Infections Requiring Intravenous Antimicrobial Therapy||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1341002|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 48, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1341003|NCT01931839|Secondary|Part A Treatment Cohort: Number of Pulmonary Exacerbations Events Per Patient-Year|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events per patient year were reported, where patient years = total number of days on study/336. Analysis includes all events in the Cumulative Study Period for Arm 1 and 3, and all events in the Current Study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 & 3, & included all participants randomized in previous studies & dosed. FAS (Study 105) was used for Arm 2 & 4, & included all participants randomized in Part A Treatment Cohort & dosed in current study 105. ‘Number Analyzed’=those participants who were evaluable at specified time points for each arm.|||events per patient year||95% Confidence Interval|Number
1341004|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in BMI at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||kg/m^2||Standard Deviation|Mean
1341005|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Body Mass Index (BMI) at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|BMI = (Weight in kilogram [kg]) divided by (Stature in meters [m]) ^2. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||Kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
1341006|NCT01931839|Secondary|Part B Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
1341007|NCT01931839|Secondary|Part A Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent change||Standard Error|Least Squares Mean
1341008|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent predicted of FEV1||Standard Deviation|Mean
1341009|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) At Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|Full Analysis Set (FAS) study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent predicted of FEV1||Standard Error|Least Squares Mean
1341010|NCT01931839|Primary|Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug was considered treatment-emergent.|Day 1 up to Week 105 (Study 105)|Safety Set (study 105) included all participants in the Treatment Cohort Part B who were exposed to any amount of study drug.|||participants|||Number
1341011|NCT01931839|Primary|Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug was considered treatment-emergent.|Day 1 up to Week 105 (Study 105)|Safety Set (study 105) included all participants in Treatment Cohort Part A who were exposed to any amount of study drug.|||participants|||Number
1341012|NCT01931709|Secondary|Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response|Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"One participant had to be excluded from this analysis:~[1] pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."|||percent change||Full Range|Median
1341013|NCT01931709|Secondary|Overall Survival|Will be examined using Cox proportional hazards regression.|From time of surgery until death, assessed up to 5 years|||||||
1341014|NCT01931709|Secondary|Time From Surgery to Breast Cancer Recurrence or Death|Will be examined using Cox proportional hazards regression.|From surgery to breast cancer recurrence or death, assessed up to 5 years|||||||
1341015|NCT01931709|Secondary|Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response|Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"Three participants had to be excluded from this analysis:~mid-therapy PET images got lost due to a technical error;~pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes;~pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."|||percent change||Full Range|Median
1341016|NCT01931709|Secondary|Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response|Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"Three participants had to be excluded from this analysis:~mid-therapy PET images got lost due to a technical error;~pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes;~pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."|||percent change||Full Range|Median
1341017|NCT01931709|Primary|Number of Participants With Favorable Pathologic Response at Surgery|"The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as:~No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0)~Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)"|At time of surgery||||Participants|||Count of Participants
1341018|NCT01931527|Secondary|AFTER Rasburicase Plasma FRAP (Fe⁺² · Lˉ¹)|Ferric-Reducing Antioxidant Potential|12 hours after reducing uric acid|AFTER rasburicase plasma FRAP only measured in subjects with high uric acid|||mmol Fe⁺² · Lˉ¹||Standard Error|Mean
1341019|NCT01931527|Secondary|Baseline Plasma FRAP|Ferric-Reducing Antioxidant Potential|Before reducing uric acid||||mmol Fe⁺² · Lˉ¹||Standard Error|Mean
1341024|NCT01931527|Secondary|The Effect of Reducing Uric Acid on Oxidative Status|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). Systemic (urinary isoprostanes) and skeletal muscle (carbonylated protein ratio) oxidative stress and total antioxidant capacity (plasma TRAP and FRAP) will be measured in obese subjects with high uric acid before and after uric acid reduction. Levels of isoprostanes were normalized to urinary creatinine and reported at ng/mg.|12 hours after reducing uric acid||||ng/mg||Standard Error|Mean
1341025|NCT01931527|Primary|Percent Increase in Insulin-stimulated Glucose Uptake|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure percent increase in insulin-stimulated glucose uptake in obese subjects with high uric acid before and after uric acid reduction.|12 hours after reducing uric acid||||% incr. in insulin-mediated gluc. uptake||Standard Error|Mean
1341026|NCT01931475|Secondary|Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). Response to treatment is defined by endpoint PGI rating of either “much better” or “very much better”.The last observation carried forward (LOCF) method will be used for these analyses.|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||percentage of participants|||Number
1341027|NCT01931475|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.The last observation carried forward (LOCF) method will be used for these analyses.|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||percentage of participants|||Number
1341028|NCT01931475|Secondary|Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)|Evaluation on whether the change in BPI average pain intensity scores is a direct analgesic effect of duloxetine and is independent of treatment effect on mood, as measured by Hospital Anxiety and Depression Scale (HADS) depression subscale (HADS-D), or anxiety as measured by HADS anxiety subscale (HADS-A). Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Deviation|Mean
1341029|NCT01931475|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores|HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale [0 (low level of anxiety or depression) to 3 (high level of anxiety or depression)], giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Mean was calculated using analysis of covariance (ANCOVA) and adjusted for treatment, pooled investigator, and baseline score. The last observation carried forward (LOCF) method will be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Mean
1341030|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Interference|BPI Interference Average Score is a self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people,sleep, and enjoyment of life.The average Interference scores ranged from 0 to 10. General activity, mood,walking ability, normal work,relations with other people, sleep and enjoyment of life is each is a self-reported scale that measures the interference of pain in the past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.The Interference scores ranged from 0 (does not interfere) to 10 (completely interferes).Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1341031|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Severity|BPI Severity of Worst Pain is self-reported scale that measures the severity of pain based on the worst pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Right Now Pain is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1341032|NCT01931475|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline,13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1341033|NCT01931475|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores|WOMAC consists of 24 items divided into 3 subscales:Pain(5 items):during walking,using stairs,in bed,sitting or lying,and standing Stiffness;(2 items):after first waking and later in the day Physical Function;(17 items):stair use,rising from sitting, standing, bending,walking,getting in/out of a car,shopping,putting on/taking off socks,rising from bed,lying in bed,getting in/out of bath,sitting,getting on/off toilet,heavy household duties,light household duties.Each question is answered using a 5-point Likert scale(0 to 4).Pain subscale has a range of scores of 0(none) to 20(extreme).Stiffness subscale has a range of scores of 0(none) to 8(extreme).Physical function subscale has a range of scores of 0(none) to 68(extreme).Total score ranges from 0(none) to 96(extreme).Least squares(LS) mean was calculated using analysis of covariance(ANCOVA) and adjusted for treatment, pooled investigator,and baseline score.Last observation carried forward (LOCF) method was be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1341034|NCT01931475|Secondary|Patient Global Impressions of Improvement (PGI-I) Score|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1341035|NCT01931475|Primary|Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1341036|NCT01931462|Secondary|Complication Rates|Complication rates will be estimated using the methods of Kaplan and Meier.|During the operation||||participants with complications|||Number
1341037|NCT01931462|Secondary|Tumor Margin|The percentage of subjects with tumor positive margins will be reported. Tissue pathology will occur during the operation and a final tissue pathology will be performed 6 weeks after the operation.|During the operation and 6 weeks post-operation||||percentage with tumor positive margins|||Number
1341038|NCT01931462|Secondary|Change in Functional Renal Volume|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in functional renal volume as measured by MRI. We will calculate the mean, median, standard deviation, and range of values for change in functional renal volume as measured by MRI.|Within 30 days prior to operation and 6 weeks post-operation|Subject renal volume not measured. Only normal/abnormal renal function was assessed.||||||
1341039|NCT01931462|Secondary|Change in Renal Function|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in renal function by nuclear scan and creatinine clearance. We will calculate the mean, median, standard deviation, and range of values for change in renal function by nuclear scan and creatinine clearance.|Within 30 days prior to operation and 6 weeks post operation||||mg/dL (creatinine)|||Number
1341040|NCT01931462|Secondary|Clamp Time|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring clamp time. We will calculate the mean, median, standard deviation, and range of values for clamp time.|During the operation|This 1 subject was not clamped during the operation.|||minutes|||Number
1341041|NCT01931462|Secondary|Operative Time|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring operative time. We will calculate the mean, median, standard deviation, and range of values for operative time.|During the operation||||minutes|||Number
1341042|NCT01931462|Secondary|Blood Loss|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring blood loss. We will calculate the mean, median, standard deviation, and range of values for blood loss.|During the operation||||mL|||Number
1341043|NCT01931462|Primary|To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.|We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score)|30 days prior to surgery (Baseline) and 6 weeks post surgery||||estimated Glomerular Filtration Rate|||Number
1341044|NCT01931397|Other Pre-specified|Changes in Adherence Parameters to Home DBS Method|"We will calculate the percent of returned DBS filter papers to OHSU on a monthly basis utilized for TAC and Cr analysis.~we calculated the percentage as the number of DBS that were actually received divided by the total number of DBS expected to be received from participants over the study time period"|At baseline then every 3 months for 12 months|The number of DBS cards expected to be received by those 28 patients were 279 DBS samples.|||percentage of DBS cards|Total number of DBS cards||Number
1341045|NCT01931397|Other Pre-specified|Mean Tacrolimus Blood Levels Measured by DBS Over Study Period According to Age|Mean Tacrolimus blood levels obtained by DBS in each patient over their time in the study in children who are 12 years and over versus those less than 12 years of age.|up to 12 months|We analyzed a total of 216 dried blood spots for Tacrolimus blood levels measured in ng/ml|||ng/ml|number of blood samples|Standard Deviation|Mean
1341046|NCT01931397|Secondary|Percentage of Families Preferring DBS Method|"The % of families who anticipated preference of DBS method over intravenous blood draws at the time of enrollment and then the % of those who preferred DBS at end of study period (12 months).~Families include parents/caregivers and participants who are over 10 years of age were asked to fill in the preference scale separately.~Preference for DBS Testing was measured using a Visual Analog Scale (VAS) on which a zero was equivalent to no preference for DBS versus laboratory-based monitoring and on which positive numbers indicated greater preference for DBS (up to +72) and negative scores indicated a greater preference for laboratory-based monitoring (down to -72)."|At baseline and then at 12 months|25 families participated in the preference survey at time of enrollment and only 15 families completed the survey at the end of the study period (12 months).|||% of families|||Number
1341047|NCT01931397|Primary|Variability of Tacrolimus Blood Levels Measured by DBS Over Time|Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.|12 months|9 participants were excluded from final analysis because they submitted two or less evaluable blood samples. A total of 216 DBS samples were received during the study|||ng/ml|blood samples|Standard Deviation|Mean
1341048|NCT01931150|Primary|Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions|Change from Baseline in the Number of Lesions at 28 days|28 days||||participants|||Number
1341049|NCT01931059|Other Pre-specified|Feedback-based Probabilistic Classification Task|On each trial, participants will view one of four images and will be asked to guess whether it belongs to Category A or B. For each participant, the four images will be randomly assigned to be stimuli S1, S2, S3 and S4 (these are abstract visual stimuli denoted with numbers (stiumulus 1, stimulus 2, etc). A different set of similar images (S5-S8; S9-S12, etc) will be used for repeated testing. On any given trial, stimuli S1 and S3 will belong to Category A with 90% probability and to Category B with 10% probability, while stimuli S2 and S4 will belong to Category B with 90% probability and to Category A with 10% probability. Stimuli S1 and S2 will be used in the reward-learning task and S3 and S4 in punishment-learning task. Two stimuli per valence will be employed in order to balance category outcome frequencies, so that one stimulus in each task will be associated with each outcome.|Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days)|We lumped individuals from both arms to four groups depending on the task and the medication status and calculated the percentage of correct responses. Due to computer problems 3 subjects' data were lost.|||percentage of correct response||Standard Deviation|Mean
1341050|NCT01931059|Secondary|Simpson-Angus Extrapyramidal Side Effects Scale|The secondary outcome measures are the scores from side effect scales (Simpson-Angus Extrapyramidal Side Effects. It will measured in synchrony with Repeated Battery for the Assessment of Neuropsychological Status to explore if any of these measures would correlate with network changes in the brain. The Simpson-Angus scale is 0 if there is no extrapyramidal side effects, and is higher the worst the symptoms are.|2 times on risperidone day and on placebo day|We analyzed the difference between patients who received drug versus placebo on the first day. 0 would mean no side effects after administration of risperidone or placebo.|||units on a scale||Standard Deviation|Mean
1341051|NCT01931059|Primary|Repeatable Battery for the Assessment of Neuropsychological Status|"This will measure the subject's cognitive performance. RBANS is a well-characterized repeatable battery to measure a wide array of cognitive performance in different cognitive domains. We will use Total Score in RBANS: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. More detailed information is available: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 20 (3): 310–9. doi:10.1076/jcen.20.3.310.823. PMID 9845158.~Here we calculated the difference of T-scaled total RBANS score between risperidone day and placebo day in all participants"|The change of RBANS scores between placebo and treatment conditions on two consecutive days||||RBANS T-Scale point difference||Standard Deviation|Mean
1341052|NCT01930890|Primary|Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).|||participants|||Number
1341053|NCT01930890|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).|||participants|||Number
1341054|NCT01930799|Secondary|Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire|The Patient Post-Video Questionnaire was based on 5 individual questions assessing the patient’s perception of the utility of the video in helping them 1) understand how MS can affect the bladder, 2) how to recognize bladder symptoms, 3) understand various treatment options, 4) understand self-help strategies, and 5) better manage their bladder problems. Percentages represent the proportion of patients who “agree/completely agree” with each question. Patients viewed the video at the Baseline visit, then completed the Patient Post-Video Questionnaire immediately after viewing the video at the Baseline visit.|Baseline|Eligible enrolled subjects|||Percentage of Patients|||Number
1341055|NCT01930799|Primary|Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores|The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.|Baseline, Month 6|Eligible and enrolled subjects who completed the Month 6 visit|||Scores on a Scale||Standard Deviation|Mean
1341056|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
1341057|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
1341058|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
1341059|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
1341060|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - No DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||mm Hg||Standard Error|Mean
1341061|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||mm Hg||Standard Error|Mean
1341062|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341063|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341064|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341065|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341066|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341067|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341068|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341069|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341070|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341071|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341072|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341073|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341074|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341075|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341076|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341077|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341078|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341079|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341080|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341081|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341082|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341083|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341084|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341085|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341086|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341087|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341088|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341089|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
1341090|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341091|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341092|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341093|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341094|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341095|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341096|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341097|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
1341098|NCT01930487|Secondary|Change in Ocular Perfusion Pressure|change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)|baseline and 30 days|patients completing both study periods|||mm Hg||Standard Error|Mean
1341099|NCT01930487|Primary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
1341100|NCT01930487|Primary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
1341101|NCT01930435|Secondary|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period|during 12 weeks duration||||participants|||Number
1341102|NCT01930435|Secondary|Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification|Feeding Tube Placement in Patients Who Use Personalized Sterile Humidification, as determined by placement of either nasogastric or gastrostomy tube. This was enumerated as the number of participants who had a feeding tube placed.|over 12 weeks duration||||participants|||Number
1341103|NCT01930435|Secondary|Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks|The maximum severity of clinician rating of mucositis observed over 12 weeks, as graded on a scale ranging from 1 (minimal mucositis) to 3 (confluent mucositis) to 5 (death) using the Common Terminology Criteria for Adverse Events v 4.0|over 12 weeks duration||||units on a scale||Standard Deviation|Mean
1341104|NCT01930435|Secondary|Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.|Compliance was pre-specified in the protocol as self-reported usage of the device at a level equal to or greater than 60% of the formal recommended usage. This cut-off at 60% represented the median of the distribution of the usage of the device among all patients. The outcome measure is the percentage of participants who reported using the device at a level equal to or greater than 60% of the total prescribed usage.|over entire 12 weeks duration||||percentage of participants|||Number
1341105|NCT01930435|Primary|Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.|The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0–10 NRS, with 0 being “not present” and 10 being “as bad as you can imagine.” There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food, mouth/throat sores, and problems with teeth or gums. Scores for the subscales (general, interference, HN) are averaged so that a score is obtained from 0-10 for each subscale. The mean change in quality of life is calculated as the average scores at 6 weeks minus the average of the scores at baseline. Therefore a positive value represents a worsened quality of life and a negative value is an improvement in quality of life.|Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]||||units on a scale||95% Confidence Interval|Mean
1341106|NCT01930162|Secondary|Incidence of Relapse-free Survival Within One Year|Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
1341107|NCT01930162|Secondary|Incidence of Overall Survival Within One Year|Overall survival is the proportion of patients who were alive at the end of the one year study period.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
1341108|NCT01930162|Secondary|Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year|NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
1341109|NCT01930162|Secondary|Incidence of Neutrophil Recovery Within 42 Days|Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L.|42 days|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
1341110|NCT01930162|Primary|Absence of Graft Failure at Day 42|This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.|42 days|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
1341111|NCT01930058|Secondary|Apparent Terminal Plasma Half-life (t½) of MK-8876|t½ is the time required for the maximum plasma drug concentration to reduce by 50% post-dose. Plasma t½ was determined on Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Day 7|All participants in Panels A, B, and E are included in the analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1341112|NCT01930058|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8876|Tmax is a measure of time required to reach the maximum plasma drug concentration post-dose. Plasma Tmax was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||Hours||Full Range|Median
1341113|NCT01930058|Secondary|Trough Plasma Concentration (C24hr) of MK-8876|C24hr is a measure of the plasma drug concentration 24 hours post-dose (i.e., trough concentration). Plasma C24hr was determined on Day 1 and Day 7 of MK-8876 dosing.|24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
1341114|NCT01930058|Secondary|Maximum Plasma Concentration (Cmax) of MK-8876|Cmax is a measure of the maximum plasma concentration of drug post-dose. Plasma Cmax was determined on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
1341115|NCT01930058|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hr post-dose. Plasma AUC0-24hr was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||µM*hr||Geometric Coefficient of Variation|Geometric Mean
1341116|NCT01930058|Primary|Mean Change From Baseline in HCV Viral Load|The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.|Baseline and Day 7|All participants in Panels A, B, and E are included in the analysis.|||Log10 change||Standard Error|Mean
1341117|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.|||nM||95% Confidence Interval|Geometric Mean
1341118|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.|||hr.nM||95% Confidence Interval|Geometric Mean
1341119|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.|||nM||95% Confidence Interval|Geometric Mean
1341120|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.|||nM||95% Confidence Interval|Geometric Mean
1341121|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.|||hr.nM||95% Confidence Interval|Geometric Mean
1341122|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.|||nM||95% Confidence Interval|Geometric Mean
1341123|NCT01929993|Primary|The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.|Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.|one month after the procedure|Any compromised margin.|||participants|||Number
1341124|NCT01929980|Primary|Number of Participants With Response|"For Autoimmune Hemolytic Anemia- At least 3 of 5 criteria should be met.~Stabilization of hemoglobin without transfusions by 2 weeks~Conversion of DAT from + to - by 6 weeks~Normalization of serum haptoglobin levels by 6 weeks~Normalization of indirect bilirubin levels by 6 weeks~Reduction in the frequency of transfusions by 50% by 4 weeks~For Autoimmune Neutropenia- At least 2 of 3 criteria should be met.~Stabilization of absolute neutrophil count by 2 weeks~Undetectable antineutrophil antibodies by 6 weeks~Reduction in GCSF dose by 50% by 6 weeks~For Autoimmune Thrombocytopenia- At least 2 of 3 criteria should be met.~Stabilization of platelet count without platelet transfusions by 2 weeks~Undetectable antiplatelet antibodies by 6 weeks~Reduction in the frequency of platelet transfusions by 50% from pre-bortezomib values by 6 weeks"|6 weeks||||participants|||Number
1341152|NCT01929759|Secondary|Effect of EFV and Its Metabolites|Level of EFV (efavirenz) in Atripla and its two known metabolites known to cause cerebral side effects, 7-hydroxy (OH) EFV and 8-OH EFV, were measured in the plasma prior to switch off Atripla and after 8 weeks of RAL-based regimen (no EFV).|week 0 and week 8||||participants|||Number
1341153|NCT01929759|Secondary|Markers of Immune Activation|Change in markers of immune activation and inflammation associated with change to Stibild: sCD14, IP-10,sCD163, IL-6)|week 0 and week 8|Inflammatory markers were measured pre- and post-drug switch from Atripla to Stibild.|||pg/ML||Standard Deviation|Mean
1341125|NCT01929889|Primary|Change in Social Cognition at 12 Weeks|"Facial Affect Perception Test that assesses the ability to accurately recognize facially expressed emotions as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 30 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome.~Cognitive Empathy Test that assesses the ability to accurately determine the emotional expression of another person as depicted in a static image of a social interaction as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 60 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome."|baseline and twelve weeks||||units on a scale||Standard Deviation|Mean
1341126|NCT01929876|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Itraconazole and Hydroxy-Itraconazole|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0-24) of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post cobimetinib dose on Day 4|PK population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341127|NCT01929876|Secondary|Tmax of Itraconazole and Hydroxy-Itraconazole|Time to reach maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||hours||Full Range|Median
1341128|NCT01929876|Secondary|Cmax of Itraconazole and Hydroxy-Itraconazole|Maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341129|NCT01929876|Secondary|Apparent Volume of Distribution (Vz/F) of Cobimetinib With and Without Itraconazole|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
1341130|NCT01929876|Secondary|Apparent Clearance (CL/F) of Cobimetinib With and Without Itraconazole|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1341131|NCT01929876|Secondary|Plasma Half-Life (t1/2) of Cobimetinib With and Without Itraconazole|Plasma half-life is the time measured for the plasma concentration to decrease by one half.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||hours||Full Range|Median
1341132|NCT01929876|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Cobimetinib With and Without Itraconazole|AUC (0-t) = Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t) of cobimetinib with and without itraconazole was assessed. It was calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1341133|NCT01929876|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Cobimetinib With and Without Itraconazole|Time to reach maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||hours||Full Range|Median
1341134|NCT01929876|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of Cobimetinib With and Without Itraconazole|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) of cobimetinib with and without itraconazole, assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341135|NCT01929876|Primary|Maximum Observed Plasma Concentration (Cmax) of Cobimetinib With and Without Itraconazole|Maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of cobimetinib and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1341136|NCT01929863|Secondary|Median Time to Observed Peak Plasma Concentration (Tmax) When Co-dosed With GSK2330672 or Placebo on Day 7|Tmax is defined as the time at which Cmax is observed, determined directly from the raw concentration-time data. Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|PK Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
1341137|NCT01929863|Secondary|Maximum Plasma Concentration of Metformin (Cmax) in Presence of GSK2330672 or Placebo on Day 7|Cmax is defined as the first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7. Analysis was done using a mixed effects model with fixed effect terms for treatment, period, and sequence. Participant within sequence was fitted as a random effect in the model.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341138|NCT01929863|Secondary|AUC From Time 0 to 10 h (AUC 0-10 h) of Metformin in Presence of GSK2330672 or Placebo on Day 7|AUC(0-10) for metformin when co-dosed with GSK2330672 or placebo is defined as the the area under the plasma concentration-time curve from time 0 to 10 h. It was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7. Analysis was done using a mixed effects model with fixed effect terms for treatment, period, and sequence. Participant within sequence was fitted as a random effect in the model.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|Pharmacokinetic (PK) Population was defined as participants from the safety population who had plasma metformin and or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)*h/mL||Geometric Coefficient of Variation|Geometric Mean
1341139|NCT01929863|Secondary|Maximum and Weighted Mean Change From Baseline in Plasma Glucose Concentrations Over a 24 Hour (h) Period on Day 7|Baseline was defined as the time matched assessment done on Day -1. Change from baseline was calculated by subtracting the baseline (Day -1) time matched values from the post-baseline value (Day 8). Data is reported for fasting glucose level and for weighted mean and maximum values for fasting, 0-4 h, 4-10 h, 10-14 h and 0-24 h. Area under the curve (AUC) with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times). The weighted mean was then determined by dividing the AUC by the observed length of the collection interval (time of last assessment – time of first assessment in h). Analysis was done using analysis of covariance (ANCOVA) model where, change from baseline was summation of baseline, period, sequence and treatment. Participants were fitted as a random effect.|Baseline (Day -1) and Day 7 of each treatment period|Safety Population. Only those participants available at the specified time points were analyzed.|||mg/deciliter||Standard Deviation|Mean
1341140|NCT01929863|Primary|Mean Change From Baseline in Overall Gastrointestinal Symptom Rating Scale (GSRS) Scores|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS is the mean of questions 1-15 and range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms. Baseline was defined as the assessment done on Day -1. Change from baseline was calculated by subtracting the baseline (Day -1) values from the post-baseline value (Day 8).|Baseline (Day -1) and Day 8 of each treatment period|Safety Population.|||Score on scale||Standard Deviation|Mean
1341141|NCT01929863|Primary|Number of Participants in Each Category of BSFR Across Day 1 to 7|The BSFR Scale assessed stool quality using a 7-point scale, where 1=separate hard lumps like nuts (difficult to pass) and 7 = watery, no solid pieces (entirely liquid). Bristol Stool Form Scale Rating: 1=separate hard lumps, like nuts, 2=sausage shaped but lumpy, 3=like a sausage or snake but with cracks on its surface, 4=like a sausage or snake, smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, a mushy stool, 7=watery, no solid pieces. Data is reported for number of events in participants with each category of BSFR scale across Day 1 to 7 post morning dose.|Day 1 to 7 of each treatment period|Safety Population.|||Participants|||Count of Participants
1341142|NCT01929863|Primary|Number of Events of Stool or Bowel Movements of Participants Using Bristol Stool Form Rating (BSFR) Scale Across Day 1 to 7|The BSFR Scale assessed stool quality using a 7-point scale, where 1=separate hard lumps like nuts (difficult to pass) and 7=watery, no solid pieces (entirely liquid). Bristol Stool Form Scale Rating: 1=separate hard lumps, like nuts, 2=sausage shaped but lumpy, 3=like a sausage or snake but with cracks on its surface, 4=like a sausage or snake, smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, a mushy stool, 7=watery, no solid pieces. Data is reported for number of events in participants with each category of BSFR scale across Day 1 to 7 post morning dose.|Day 1 to 7 of each treatment period|Safety Population.|||Number of events|||Number
1341154|NCT01929759|Secondary|ART Regimen Preference|Evaluate patient preference in ART regimen (Atripla, EFV/FTC/TDF versus EVG/COBI/FTC/TDF) through a self-administered questionnaire.|week 0 and week 8|Patients were surveyed at the end of the study with a single question regarding their ART preference. They are asked to pick one of the 3 answers: 1. prefer Atripla, 2. prefer the new drug (Stribild) or 3. no preference. The number of patients who would like to switch to study drug, Stribild, are indicated by the percentage.|||Participants|||Count of Participants
1342900|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mmol/L||Standard Deviation|Mean
1341143|NCT01929863|Primary|Number of Participants With Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Time Post Baseline|12-lead ECG assessments were obtained pre-dose at Day 1, Day 3, Day 8 (before discharge) and Follow-up. The assessments were done using an ECG machine that automatically calculated the heart rate and measures PQ, QRS, QT, and QTc(B) intervals. Abnormal ECG findings (clinically significant or not clinically significant) were categorized. The abnormal PCI range for T2DM participants include QTc interval of >450 to <=480 milliseconds (msec) and increase from Baseline QTc interval of > 30 to <=60 msec, PR interval <110 and >220 msec and QRS interval <75 and >110 msec. ECG abnormalities were categorized as clinically significant or not clinically significant based on PCI criteria and judgment of the investigator. Baseline was defined as the mean of three replicate assessments at pre-dose on Day 1.|Up to Follow-up (up to 53 days)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1341144|NCT01929863|Primary|Number of Participants With Vital Sign Values of PCI at Any Time Post Baseline|Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Assessments were completed at pre morning dose on Day 1 (Baseline), Day 3, Day 8 (before discharge) and Follow-up. Criteria for vital sign values meeting PCI for Type 2 diabetes mellitus (T2DM) included: SBP <85 and >160 millimeters of mercury (mmHg), DBP <45 and >100 mmHg and HR <40 and >110 beats per minute (bpm). Only those parameters for which at least one value of PCI was reported are summarized.|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
1341145|NCT01929863|Primary|Number of Participants With Abnormal Results for Fecal Occult Blood Test|The assessment of fecal occult blood was done on Day 8. Stool sample was obtained any time after dosing on Day 7.|Day 8 of both treatment periods|Safety Population.|||Participants|||Count of Participants
1341146|NCT01929863|Primary|Mean Specific Gravity of Urine at Any Visit Post Baseline|Urine specific gravity is a laboratory test that shows the concentration of all chemical particles in the urine. The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. Baseline was the assessment done on Day -1 (pre dose).|Up to Follow-up (up to 53 days)|Safety Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1341147|NCT01929863|Primary|Number of Participants With Abnormal Values of Urine Dipstic Analysis of Occult Blood, Glucose, Ketones and Proteins at Any Visit Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition for urine dipstic analysis of occult blood, glucose, ketones and proteins. Baseline was the assessment done on Day -1 (pre dose). The participants were categorized with results of 1+, 2+, 3+ and trace. Only those parameters for which at least one value of these categories reported are summarized.|Up to Follow-up (up to 53 days)|Safety population.|||Participants|||Count of Participants
1341148|NCT01929863|Primary|Number of Participants With Abnormal Values of Urine Microscopic Analysis of Bacteria, Hyaline Casts (Semi-quantitive), RBC, Squamous Epithelial Cells and WBC at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition for microscopic analysis of bacteria, hyaline casts (semi-quantitive), RBC, squamous epithelial cells and WBC. Baseline was the assessment done on Day -1 (pre dose). The participants were categorized as 0-5, 6-10, 10-20, moderate, few and many. Only those parameters for which at least one value of these categories reported are summarized.|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
1341149|NCT01929863|Primary|Number of Participants With the Indicated Haematology Values of PCI at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. The following laboratory parameters of clinical haematology were analyzed: platelet count, red blood cells (RBC) count, absolute white blood cells (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was the assessment done on Day -1 (pre dose). Only those parameters for which at least one value of PCI was reported are summarized. Data is reported for participants with high WBC counts PCI, where the PCI value for T2DM participants was (relative low : 0.5 multiplier of lower limit of normal [LLN]; relative high : 1.82 multiplier of upper limit of normal [LLN]; where normal range was 3.8 - 10.8 giga cells per liter (GI/L).|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
1341150|NCT01929863|Primary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Importance (PCI) at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. The following laboratory parameters of clinical chemistry were analyzed: blood urea nitrogen (BUN), creatinine, fasting triglycerides (TGs), total cholesterol, low-density lipoprotein cholesterol (LDLc), high-density lipoprotein cholesterol (HDLc), sodium, potassium, chloride, total bicarbonate, calcium, aspartate aminotransferase (AST), ALT, gamma glutamyltransferase (GGT), alkaline phosphatase, total and direct bilirubin, uric acid, albumin and total protein. Baseline was the assessment done on Day -1 (pre dose). Only those parameters for which at least one value of PCI was reported are summarized. Data is reported for participants with high glucose PCI, where the PCI value for T2DM participants was ( low < 3.8857 millimole per liter (mmol/L); high > 15 mmol/L; normal range was 3.61 - 5.5 mmol/L).|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
1341151|NCT01929863|Primary|Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE) or Death|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (up to 53 days)|Safety Population was defined as all participants enrolled into the study who have received at least one dose of study drug (including metformin, GSK2330672, and matching placebo. One participant withdrew consent after taking period 1 study treatment of placebo + GSK2330672.|||Participants|||Count of Participants
1341155|NCT01929759|Secondary|Sleep Quality|Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality; minimum Score = 0 (better); maximum Score = 21 (worse).|week 0 and week 8||||units on a scale||Standard Deviation|Mean
1341156|NCT01929759|Secondary|Fasting Lipid Profile|Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen.|8 weeks|Change in fasting lipid profile was measured: total cholesterol, HDL and LDL levels.|||mg/dl||Standard Deviation|Mean
1341157|NCT01929759|Secondary|Neurocognitive Changes|"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain damage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~6. Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80."|week 0 and week 8|"Several Indexes were used to access neurocognitive changes: WAIS, HAMD, FRSBE, DASS-21, STAI.~Participants were given these tests prior to and after drug switch."|||units on a scale||Standard Deviation|Mean
1341158|NCT01929759|Secondary|Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8|Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) between week 0 and week 8 to identify prominent and significant changes associated with EFV use.|week 0 to week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
1341159|NCT01929759|Primary|Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)|Assess changes in neural activation correlated with affective disturbances associated with efavirenz-based therapy using fMRI employing an Emotional Word/Go-NoGo task paradigm that probes affective symptomatologies typical with EFV use, specifically anxiety/dysphoria and affective dysregulation and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-switch / Post-switch / Pre- vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect and Age incorporated as a co-variate of no interest.|week 0 and week 8|8 of 10 enrolled patients passed QA testing to be included in the final analyses. The 3 linear contrasts of Pre-switch/Post-switch/Pre- vs. Post-switch: [Neg vs.Neu] x [No-Go vs. Go] are reported as z-score (standardized effect size measures with SD=1). Z-score is obtained for each subject, group Z-score is obtained via a mixed-effects model.|||z-score|||Number
1341160|NCT01929759|Primary|Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)|Assess the change in levels of neuro-metabolites measured by MRS from week 0 (before switching to the efavirenz-based therapy) and then at week 8 (after completing 9 weeks of integrase-inhibitor based regimen with Stribild). Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain Cr, GABA and GLU.|week 0 to week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
1341161|NCT01929707|Secondary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258||Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose|All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1341162|NCT01929707|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258||Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose.|All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1341163|NCT01929707|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.|Baseline up to 21 days postdose|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1341164|NCT01929681|Secondary|Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days"|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Error|Mean
1341165|NCT01929681|Secondary|Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Error|Mean
1341166|NCT01929681|Secondary|Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three post (<30min oost treatment) minus pre (<30min pre treatment) score differences for the three treatment days"|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Error|Mean
1341167|NCT01929681|Primary|Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment."|90 minutes; change immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.|subjects completing 3 treatment visits and 1 followup visit|||units on a scale||Standard Deviation|Mean
1341168|NCT01929681|Primary|Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.|Variable based on screening visit schedule, > 2 weeks.|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Deviation|Mean
1341169|NCT01929473|Secondary|Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization|Questionnaire|365 day|||||||
1341170|NCT01929473|Secondary|Antibodies of Varicella, Mumps and Rubella|Questionnaire|0 day|||||||
1341171|NCT01929473|Secondary|Incidence of Pertussis|Questionnaire|0 day|||||||
1341172|NCT01929473|Primary|IgG|Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).|0 day, 365 day (2 points)||||EU/mL(log transformed)||Standard Deviation|Mean
1341173|NCT01929460|Secondary|Median Cyst Fluid Amylase|Median cyst fluid amylase for classification of mucinous cystic lesions|six weeks||||Units/L||Inter-Quartile Range|Median
1341174|NCT01929460|Secondary|Median Cyst Fluid Carcinoembryonic Antigen (CEA)|Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks||||ng/mL||Inter-Quartile Range|Median
1341175|NCT01929460|Secondary|Mean Cyst Fluid Amylase|Mean cyst fluid amylase for classification of mucinous cystic lesions|six weeks||||Units/L||Full Range|Mean
1341176|NCT01929460|Secondary|Mean Cyst Fluid Carcinoembryonic Antigen (CEA)|Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks||||ng/mL||Full Range|Mean
1341177|NCT01929460|Secondary|Procedure-related Complications|Number of patients with procedure-related complications|six weeks after procedure||||participants|||Number
1341178|NCT01929460|Secondary|Adverse Drug Reactions|Number of participants with adverse drug reactions|six weeks||||participants|||Number
1341179|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 6 weeks after procedure||||participants|||Number
1341180|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 4 weeks after procedure||||participants|||Number
1341181|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 2 weeks after procedure||||participants|||Number
1341187|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent “off”) from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent “off”). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||hours||Standard Deviation|Mean
1341182|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their “on ” periods and asleep in diary cards every day. Percentage of awake time spent “On” without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias [“On” time minus “On” time with troublesome dyskinesias] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “On” without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent “On” without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||percentage of awake time spent on||Standard Deviation|Mean
1341183|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “on ” periods and asleep in diary cards every day. Percentage of awake time spent on is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent on) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent on). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||percentage of awake time spent on||Standard Deviation|Mean
1341184|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “on ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On” without troublesome dyskinesias (actual hours) is calculated as [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at visit minus [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||hours||Standard Deviation|Mean
1341185|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On”(actual hours) is calculated as awake time spent “On” (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent “On” (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||hours||Standard Deviation|Mean
1341186|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Percentage of awake time spent “off” is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “off”) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent “off”). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||percentage of awake time spent off||Standard Deviation|Mean
1341817|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341188|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Participants|||Number
1341189|NCT01929317|Secondary|Number of Participants Remaining in the Study||From the start of the study medication (Week 0) until Week 52|Safety Population 2 (SP2) compraised of all participants who included in SP1 (receive at least one dose of medication in Dose Increase Effect Verification Phase) and shifted to Long-term Phase and received at least one dose of medication in Long-term Phase.|||Participants|||Number
1341190|NCT01929317|Secondary|Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12|The CGI global improvement scale allows the investigator to rate the participant’s total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Week 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1341191|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On” without troublesome dyskinesias (actual hours) is calculated as [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at visit minus [awake time spent “On” minus awake time spent “On” with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||hours||Standard Deviation|Mean
1341192|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “On”(actual hours) is calculated as awake time spent “On” (hours) at the indicated visit minus awake time spent “On” (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||hours||Standard Deviation|Mean
1341193|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Percentage of awake time spent “off” is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent “off”) from the post Baseline value (percentage of awake time spent “off”). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||percentage of awake time spent off||Standard Deviation|Mean
1341194|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods and asleep in diary cards every day. Change from Baseline in awake time spent “Off”(actual hours) is calculated as awake time spent “Off” (hours) at the indicated visit minus awake time spent “Off” (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||hours||Standard Deviation|Mean
1341668|NCT01924845|Secondary|6 Minute Walk Test (Meters)|Distance walked within 6 minutes|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Meter||Standard Deviation|Mean
1341195|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
1341196|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
1341197|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
1341198|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
1341199|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
1341200|NCT01929317|Secondary|Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
1341201|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
1341202|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
1341203|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1341204|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Percent change||Standard Deviation|Mean
1341205|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||Percent change||Standard Deviation|Mean
1341206|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1341207|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for “No” and 1 for “Yes”. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Scores on a scale||Standard Deviation|Mean
1341208|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||Scores on a scale||Standard Deviation|Mean
1341209|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Scores on a scale||Standard Deviation|Mean
1341210|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Participants|||Number
1341211|NCT01929317|Secondary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits|The Japanese Unified Parkinson’s Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|||Scores on a scale||Standard Deviation|Mean
1341212|NCT01929317|Primary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group|The Japanese Unified Parkinson’s Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline and Week 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|||Scores on a scale||Standard Deviation|Mean
1341285|NCT01928927|Secondary|Change in Waist Circumference From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist circumference."|||cm||Inter-Quartile Range|Median
1341213|NCT01929135|Secondary|Change in Gingival Index|"Determined as score assigned to each site evaluated respect to clinical criteria as followed:~Score Criteria:~0. No inflammation~Mild inflammation, slight change in color, slight edema, no bleeding on probing.~Moderate inflammation, moderate glazing, redness, bleeding on probing.~Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.~Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated.~The change was calculated as baseline measure minus 1 month later measure."|baseline and 1 month after intervention||||score on a scale||Standard Deviation|Mean
1341214|NCT01929135|Secondary|Change in Bleeding on Probing Index (BOP)|"The bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined.~Change in BOP: baseline measure minus 1 month later measure."|baseline and 1 month after intervention||||percentage of BOP||Standard Deviation|Mean
1341215|NCT01929135|Secondary|Change in Clinical Attachment Level (CAL)|"The Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual).~Change in CAL: baseline measure minus 1 month later measure."|baseline and 1 month after intervention||||millimeters||Standard Deviation|Mean
1341216|NCT01929135|Secondary|Change in Mean Pocket Depth (PD)|"The PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal).~Change in mean PD: baseline measure minus 1 month later measure."|baseline and 1 month later||||millimeters||Standard Deviation|Mean
1341217|NCT01929135|Primary|Change in Periodontal Inflammation Surface Area (PISA)|"PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing.~Change in PISA: baseline measure minus 1 month later measure."|baseline and 1 month later of intervention||||square millimeters||Standard Deviation|Mean
1341218|NCT01929083|Other Pre-specified|Ratio of Serum Progesterone:Estradiol Concentrations During the Progesterone and Placebo Phases||After 7 days of progesterone or placebo||||Ratio||Standard Deviation|Mean
1341219|NCT01929083|Other Pre-specified|Serum Progesterone Concentrations During Progesterone and Placebo Phases||After 7 days of progesterone or placebo||||ng/mL||Standard Deviation|Mean
1341220|NCT01929083|Other Pre-specified|Serum Estradiol Concentrations During the Progesterone and Placebo Phases||Following 7 days of progesterone or placebo||||pg/mL||Standard Deviation|Mean
1341221|NCT01929083|Other Pre-specified|Maximum (Peak) Serum Ibutilide Concentrations During Progesterone and Placebo Phases||Within 1 hour following ibutilide administration (0, 15 & 30 minutes and 1 hours.)||||pg/mL||Standard Deviation|Mean
1341222|NCT01929083|Other Pre-specified|Adverse Effects Associated With Ibutilide in the Progesterone and Placebo Phases||Within 8 hours following ibutilide administration||||percentage of participants|||Number
1341223|NCT01929083|Primary|Area Under the QTcI - Time Curve (AUEC)||From beginning of 10-minute ibutilide infusion to 1 hour following ibutilide infusion||||ms*hr||Standard Deviation|Mean
1341224|NCT01929083|Primary|Maximum % Change From Baseline in QTcI Intervals Following Ibutilide Administration||After 7 days of progesterone or placebo||||percentage change from baseline value||Standard Deviation|Mean
1341225|NCT01929083|Secondary|Incidence of Progesterone-associated Adverse Effects Compared to Placebo||During 7 days of treatment with oral progesterone or placebo||||percentage of participants|||Number
1341226|NCT01929083|Primary|Maximum Individual-corrected QT Interval (QTcI)|QT intervals will be corrected as follows: Prior to randomization, subjects will come to the Indiana Clinical Research Center for a 12-hour stay, during which three ECGs, one minute apart, will be obtained at the following times: 0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours. Subjects will be discharged, and then return then next morning for the 24 hour ECG. QT and RR intervals will be used to determine each subject’s individual rate-corrected QT interval (QTcI) using the parabolic model QT = β•RRα, where RR is the interval between adjacent QRS complexes, and α and β are subject-specific correction factors.|0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours post-ibutilide administration||||ms||Standard Deviation|Mean
1341227|NCT01929083|Primary|Baseline (Pre-Ibutilide) QTcI Intervals||After 7 days of progesterone or placebo, prior to receiving IV ibutilide||||ms||Standard Deviation|Mean
1341228|NCT01929044|Secondary|Proportion of Patients Who Need the Second Injection|Proportion of patients who need the second injection at 20 minutes after the first injection.|20 minutes after the first injection.|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Percentage of Patients||95% Confidence Interval|Number
1341229|NCT01929044|Secondary|Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection|Global assessment of efficacy by the patient. The patient was to assess the efficacy at 120 min after the first injection using a 4-point rating scale by answering the question: “How would you rate the effect of the study medication for relieving your acute gastric or intestinal spasm-like pain?” (0 = poor; 1 = fair; 2 = good; 3 = very good).|120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Percentage of Patients|||Number
1341230|NCT01929044|Secondary|PID From Pre-dose Baseline at 120 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 120 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1341286|NCT01928927|Secondary|Change in Waist Circumference From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist circumference."|||cm||Inter-Quartile Range|Median
1341231|NCT01929044|Secondary|PID From Pre-dose Baseline at 60 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 60 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 60 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1341232|NCT01929044|Secondary|PID From Pre-dose Baseline at 30 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 30 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 30 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1341233|NCT01929044|Secondary|PID From Pre-dose Baseline at 10 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 10 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 10 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1341234|NCT01929044|Primary|PID From Pre-dose Baseline at 20 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 20 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = ‘no pain’ to 10 = ‘worst pain possible’.|Baseline and 20 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS: all patients who provided any data for the primary efficacy endpoint constituted the full analysis set.), who revealed no important protocol violations that would impact the analysis of primary endpoint|||Units on a scale||Standard Error|Least Squares Mean
1341235|NCT01929031|Secondary|Time to Meaningful Pain Relief|Time to meaningful pain relief was captured by a stopwatch, which was started by the study staff immediately after the administration of the first dose of trial medication and which was to be stopped by the patient as soon as he/she felt meaningful pain relief. Time to meaningful pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||hours||95% Confidence Interval|Median
1341236|NCT01929031|Secondary|Duration of Pain Relief|Duration of pain relief was defined as the time between the administration of first dose of trial medication and first dose of rescue medication or second dose of trial medication, whichever was first. Duration of pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||hours||95% Confidence Interval|Median
1341237|NCT01929031|Secondary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h)|SPRID0-2h: Time-weighted sum of PAR and PID from 0 to 2 hours, score range: -10 (worst) to 28 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5 and 2 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 2 was considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 2 hours.|0 to 2 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||units on a scale||Standard Error|Least Squares Mean
1341238|NCT01929031|Primary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h)|SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 8 were considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 8 hours.|0 to 8 hours|Randomized patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||units on a scale||Standard Error|Least Squares Mean
1341239|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or MUGA) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= LLN, >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341240|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Electrocardiogram Findings at the Indicated Time Points|Single 12-lead ECGs were performed at Baseline, Weeks 3 to 132 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - CS, or abnormal - NCS, as determined by the investigator.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
1341861|NCT01923480|Secondary|Plasma Concentration of Phenylalanine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341241|NCT01928940|Secondary|Phase II: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3 to 132 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Kg||Standard Deviation|Mean
1341242|NCT01928940|Secondary|Phase II: Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation, or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8 and 15; Weeks 3 to 132 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of oxygen in blood||Standard Deviation|Mean
1341243|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees C, change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341244|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 bpm, change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341245|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|SBP and DBP values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 mmHg), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341246|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in ECOG Perormance Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50% of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341247|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Urinalysis Results|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for UOB, UGLU, UKET, UP and UUBIL were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341248|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, WBC counts, basophils, eosinophils, hematocrit, MCHC, MCH, MCV, monocytes and RBC count.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341256|NCT01928940|Secondary|Phase I: Number of Participants With Unconfirmed Overall Response Rate|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
1341249|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Clinical Chemistry Parameters|CCPs were graded according to NCI CTCAE garde version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline grade occurred. CCPs that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, ALT, AST, total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, LDH, total protein, urea/BUN and uric acid.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341250|NCT01928940|Secondary|Phase II: Number of Participants With Any Adverse Event and Any Serious Adverse Event|An AE is defined as any untoward MO in a part. temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xULN and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 years)|ATS Population|||Participants|||Number
1341251|NCT01928940|Secondary|Phase II: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
1341252|NCT01928940|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
1341253|NCT01928940|Secondary|Phase II: Number of Participants With Unconfirmed Overall Response|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
1341254|NCT01928940|Secondary|Phase I: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
1341255|NCT01928940|Secondary|Phase I: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
1341700|NCT01924429|Secondary|ASRS - Expanded|ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).|Baseline||||units on a scale||Standard Deviation|Mean
1341257|NCT01928940|Secondary|Phase I: Number of Participants With Confirmed Overall Response Rate|"Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR according to RECIST, version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
1341258|NCT01928940|Secondary|Phase I: Time of Occurrence of Cmax (Tmax) and Terminal Phase Half Life (t1/2) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Tmax is defined as the time of occurrence of Cmax. Tmax was determined directly from the raw concentration-time data. The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/lamdaz, where lamdaz is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data. . T1/2 was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|||hr||Full Range|Median
1341259|NCT01928940|Secondary|Phase I: Plasma Trough Concentration (Ctau) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Trough concentration is the lowest level that a drug is present in the body. Pre-dose (trough) blood samples were collected on Day 8, Day 15, Weeks 3, 8, 16 and 24 for estimating plasma trough concentration. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Ctau was determined from the raw concentration-time data.|At pre-dose on Day 8, Day 15, Weeks 3, 8, 16 and 24|PK Population.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341260|NCT01928940|Secondary|Phase I: Maximum Plasma Concentration (Cmax) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683 and GSK2167542. Cmax was determined from the raw concentration-time data.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341261|NCT01928940|Secondary|Phase I: Area Under the Plasma Concentration Versus Time Curve (AUC) of GSK2118436 and Metabolites, and GSK1120212 After Single and Repeat Dose|Blood samples were collected from each par. at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. AUC from time zero to last quantifiable concentration (concn) (AUC[0-t]) was determined using the linear trapezoidal rule for increasing concn and the logarithmic trapezoidal rule for decreasing. The AUC from time zero extrapolated to infinity (AUC[0-inf] was calculated, where data permit, as the sum of AUC(0-t) and Ct/z, where Ct is the observed plasma concn obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant. Area under the concentration-time curve over 12 hr and 24 hr dosing interval is called AUC[0-12] and AUC[0-24]. AUC(0-inf) was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population: all par. included in the ATS population for whom a PK sample was obtained and analyzed. Only those par. available at the specified time points were analyzed (represented by n=X in the category titles).|||hr*nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
1341262|NCT01928940|Primary|Phase II: Number of Participant With Confirmed Overall Response|"Confirmed overall response (ORR) is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and blinded independent central review (BICR)."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
1341263|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram (ECHO)|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= lower limit of normal (LLN), >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341282|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|24 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+CD38+HLA-DR+ data."|||Percent of CD4+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
1341264|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Electrocardiogram (ECG) Findings at the Indicated Time Points|Single twelve (12)-lead ECGs were perfomred at Baseline, Weeks 3 to 132 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
1341265|NCT01928940|Primary|Phase I: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from Baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit ( average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Kilogram (Kg)||Standard Deviation|Mean
1341266|NCT01928940|Primary|Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen,that is called as blood oxygen saturation or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8,15; Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of oxygen in blood||Standard Deviation|Mean
1341267|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
1341268|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
1341269|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 millimeters of mercury [mmHg]), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
1341270|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50 percent (%) of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
1341271|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Urinalysis Parameters|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for urine occult blood (UOB), urine glucose (UGLU), urine ketones (UKET), urine protein (UP) and urine urobilinogen (UUBIL) were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
1341283|NCT01928927|Secondary|Change in Waist-to-hip Ratio From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist-to-hip ratio."|||waist cm : hip cm||Inter-Quartile Range|Median
1341284|NCT01928927|Secondary|Change in Waist-to-hip Ratio From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist-to-hip ratio."|||waist cm : hip cm||Inter-Quartile Range|Median
1341272|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) counts, basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes and red blood cell (RBC) count.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
1341273|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs)|CCPs were graded according to NCI CTCAE grade version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters (para) for which an increase to G3 or G4 from BL G occurred. CCPs that were not G according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those para for which the category decreased to Low or increased to High relative to the BL category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
1341274|NCT01928940|Primary|Phase I: Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as an event occurred during the first 21 days after the first dose of study drugs and met any of the following criteria, according to National Cancer Institutes (NCI) common terminology criteria for AE (CTCAE) grade (G) version 4.0: G4 hematological toxicity; G3 or G4 non-hematologic toxicity (including rash, nausea, vomiting and diarrhea only if uncontrolled with supportive therapy); rash >=G3 that required dose reduction despite supportive care; a G2 or greater non-hematological toxicity that in the judgment of the investigator and medical monitor; dose interruption of greater than 14 consecutive days due to unresolved toxicity; any new G2 or greater valvular heart disease and significant alteration in cardiac valve morphology from Baseline.|From the start of study treatment until 21 days|DLT assessment Population: all participants for whom DLT assessment was appropriately conducted|||Participants|||Number
1341275|NCT01928940|Primary|Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence (MO) in a part. temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xupper limit of normal(ULN) and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year)|All Treated Subject (ATS) Population: all participants who received at least one dose of study medication.|||Participants|||Number
1341276|NCT01928927|Secondary|Change in the Proportion of CD4+ T Cells in Lymphoid Tissue From Baseline to Week 48.|Measured as the change from entry to week 48 in %CD3+CD4+ T cells.|48 weeks||2019-01-31|01/2019||||
1341277|NCT01928927|Secondary|Change in Inflammatory Cell Population Type and Number in Adipose Tissue Biopsy Specimens From Baseline to Week 48|Measured as the change from entry to week 48 in the frequency of CD14+, CD16+,CD64+, and/or CD163+ macrophages.|48 weeks||2019-01-31|01/2019||||
1341278|NCT01928927|Secondary|Change in Inflammatory Cell Population Type and Number in Lymphoid Tissue Biopsy Specimens From Baseline to Week 48|Measured as the change from entry to week 48 in the frequency of CD14+, CD16+,CD64+, and/or CD163+ macrophages and % activated (CD38+/HLA-DR+, Ki67+) CD4 and CD8 T cells.|48 weeks||2019-01-31|01/2019||||
1341279|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|48 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+CD38+HLA-DR+ data."|||Percent of CD8+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
1341280|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|48 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+CD38+HLA-DR+ data."|||Percent of CD4+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
1341281|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|24 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+CD38+HLA-DR+ data."|||Percent of CD8+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
1341701|NCT01924429|Secondary|BRIEF-A|Behavior Rating Inventory of Executive Function®–Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)|at 4 weeks|not collected||||||
1341287|NCT01928927|Secondary|Presence of Metabolic Syndrome at Week 48.|"Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40 (101.6 cm) in men, >35 (88.9 cm) in women with the exception of Asian-Americans: >35 (88.9 cm) in men, 31 (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL."|Week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing metabolic syndrome components."|||Participants|||Count of Participants
1341288|NCT01928927|Secondary|Prevalence of Metabolic Syndrome at Week 24.|"Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40 (101.6 cm) in men, >35 (88.9 cm) in women with the exception of Asian-Americans: >35 (88.9 cm) in men, 31 (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.~NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis."|Week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing metabolic syndrome components."|||Participants|||Count of Participants
1341289|NCT01928927|Secondary|Change in HOMA-IR From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing HOMA-IR."|||(mg/dl)x(uIU/ml)/405||Inter-Quartile Range|Median
1341290|NCT01928927|Secondary|Change in Fasting Triglycerides From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting triglycerides."|||mg/dl||Inter-Quartile Range|Median
1341291|NCT01928927|Secondary|Change in Fasting Total Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting total cholesterol."|||mg/dl||Inter-Quartile Range|Median
1341292|NCT01928927|Secondary|Change in Fasting LDL Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting LDL cholesterol."|||mg/dl||Inter-Quartile Range|Median
1341293|NCT01928927|Secondary|Change in Fasting Insulin From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting insulin."|||uIU/ml||Inter-Quartile Range|Median
1341294|NCT01928927|Secondary|Change in Fasting HDL Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting HDL cholesterol."|||mg/dl||Inter-Quartile Range|Median
1341295|NCT01928927|Secondary|Change in Fasting Glucose From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting glucose."|||mg/dl||Inter-Quartile Range|Median
1341296|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+ count."|||cells/mm^3||Inter-Quartile Range|Median
1341297|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+ count."|||cells/mm^3||Inter-Quartile Range|Median
1341298|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 12|Absolute change was calculated as the value at week 12 minus the value at baseline.|baseline and week 12|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+ count."|||cells/mm^3||Inter-Quartile Range|Median
1341299|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+ count."|||cells/mm^3||Inter-Quartile Range|Median
1341300|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+ count."|||cells/mm^3||Inter-Quartile Range|Median
1341301|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 12|Absolute change was calculated as the value at week 12 minus the value at baseline.|baseline and week 12|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+ count."|||cells/mm^3||Inter-Quartile Range|Median
1341302|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β3."|||pg/ml||Inter-Quartile Range|Median
1341303|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β3."|||pg/ml||Inter-Quartile Range|Median
1341304|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β3."|||pg/ml||Inter-Quartile Range|Median
1341305|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β2."|||pg/ml||Inter-Quartile Range|Median
1341306|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β2."|||pg/ml||Inter-Quartile Range|Median
1341307|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β2."|||pg/ml||Inter-Quartile Range|Median
1341308|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β1."|||pg/ml||Inter-Quartile Range|Median
1341309|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β1."|||pg/ml||Inter-Quartile Range|Median
1341310|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β1."|||pg/ml||Inter-Quartile Range|Median
1341311|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD163."|||ng/ml||Inter-Quartile Range|Median
1341312|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD163."|||ng/ml||Inter-Quartile Range|Median
1341313|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD163."|||ng/ml||Inter-Quartile Range|Median
1341314|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD14."|||mcg/ml||Inter-Quartile Range|Median
1341315|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD14."|||mcg/ml||Inter-Quartile Range|Median
1341316|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD14."|||mcg/ml||Inter-Quartile Range|Median
1341317|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing hyaluronic acid."|||ng/ml||Inter-Quartile Range|Median
1341318|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing hyaluronic acid."|||ng/ml||Inter-Quartile Range|Median
1341319|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing hyaluronic acid."|||ng/ml||Inter-Quartile Range|Median
1341320|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CICP."|||ng/ml||Inter-Quartile Range|Median
1341321|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CICP."|||ng/ml||Inter-Quartile Range|Median
1341322|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CICP."|||ng/ml||Inter-Quartile Range|Median
1341323|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adiponectin."|||ng/ml||Inter-Quartile Range|Median
1341324|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adiponectin."|||ng/ml||Inter-Quartile Range|Median
1341325|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adiponectin."|||ng/ml||Inter-Quartile Range|Median
1341326|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-7."|||pg/ml||Inter-Quartile Range|Median
1341327|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-7."|||pg/ml||Inter-Quartile Range|Median
1341328|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-7."|||pg/ml||Inter-Quartile Range|Median
1341329|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-6."|||pg/ml||Inter-Quartile Range|Median
1341330|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-6."|||pg/ml||Inter-Quartile Range|Median
1341702|NCT01924429|Secondary|BRIEF-A|Behavior Rating Inventory of Executive Function®–Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)|at one week|not collected||||||
1341331|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-6."|||pg/ml||Inter-Quartile Range|Median
1341332|NCT01928927|Secondary|Highest Grade Non-biopsy-related Adverse Event|"Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant.~Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table.~NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol."|after baseline to week 48|All Step 2 participants|||Participants|||Count of Participants
1341333|NCT01928927|Secondary|Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adipose collagen VI deposition."|||percent area stain positive||Inter-Quartile Range|Median
1341334|NCT01928927|Secondary|Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adipose tissue fibronectin deposition."|||percent area stain positive||Inter-Quartile Range|Median
1341335|NCT01928927|Secondary|Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing lymphoid tissue fibronectin deposition."|||percent area stain positive||Inter-Quartile Range|Median
1341336|NCT01928927|Primary|Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing subcutaneous abdominal adipose tissue collagen I deposition."|||percent area stain positive||Inter-Quartile Range|Median
1341337|NCT01928927|Primary|Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48|Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing lymphoid tissue collagen I deposition."|||percent area stain positive||Inter-Quartile Range|Median
1341338|NCT01928862|Secondary|"Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire"|"Subject’s Tolerability and Satisfaction Questionnaire consists of three questions. Question (Q)1 was “How easy was it to drink the bowel cleanout medicine?” and Q2 was “How did the bowel cleanout medicine taste?”. Q3 had five subparts namely: 1. “How often did your tummy hurt since you started the medicine?” and 2. “How often did you feel fullness in your tummy, since you started the cleanout?” and 3. “How often did you wake up last night” and 4. “How often did you feel sick to your stomach (nausea) since you started the cleanout?’ and 5. “How much were you bothered by going to the washroom since you started the cleanout?”~Satisfactory was defined as a response of 1 (Very Easy) or 2 (Easy) on Q1 and a response of 1 (Very Well) or 2 (Well) on Q2.~Tolerable was defined as a response of 1 (Never) or 2 (Rarely) to the five subparts specified in Q3."|1 day of colonoscopy|The secondary efficacy analysis was based on the ITT analysis set, which included all participants who were randomized.|||participants|||Number
1341339|NCT01928862|Secondary|Number of Participants Who Took the Assigned Dose for Colon Cleansing|The proportion of participants who took the assigned dose of Prepopik® was assessed.|Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
1341340|NCT01928862|Secondary|Number of Participants With Abnormal Findings in Physical Examination|Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented.|From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
1341341|NCT01928862|Secondary|Number of Participants With Abnormal Findings in Laboratory Tests|Proportion of participants with abnormal findings in laboratory tests are presented.|From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
1341703|NCT01924429|Secondary|BRIEF-A|Behavior Rating Inventory of Executive Function®–Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (0 to 100, with 50 +/-1 SD = ‘Normal’, higher is worse, more impaired)|Baseline||||t-score||Standard Deviation|Mean
1341342|NCT01928862|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant taking part in a clinical trial. Proportion of participants with AE are presented.|Up to 33 days after colonoscopy|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
1341343|NCT01928862|Primary|"Percentage of Participants Defined by Excellent or Good in the Aronchick Scale"|Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is “excellent” or “good” on this 4-point scale.|On the day of colonoscopy|The primary efficacy analysis was based on the intention-to-treat (ITT) analysis set, which included all participants who were randomized.|||percentage of participants||90% Confidence Interval|Number
1341344|NCT01928797|Secondary|Number of Participants With Umbilical Cord pH|Number of participants with Umbilical cord pH <7.2|Intraoperative|1 out of 30 babies had umbilical pH < 7.2|||number of participants|||Number
1341345|NCT01928797|Secondary|Nausea and Vomiting|incidence of nausea, and vomiting|intraoperatively during surgery|Nausea|||Participants|||Count of Participants
1341346|NCT01928797|Primary|Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values|"To determine mean cardiac output differences between the control group and the study group that used cardiac output data. In the control group, the cardiac output data was measured but not used for correcting blood pressure changes. Blood pressure changes were used for administering phenylephrine or ephedrine. In the study group, cardiac output data was used, in addition to blood pressure data, to correct both cardiac output and blood pressures to be maintained within 20% of baseline measurements.~After spinal anesthesia for cesarean delivery, the cardiac output and blood pressure tends to decrease. When this occurs, the blood flow to the uterus and the baby decrease resulting in fetal heart changes. Since we do not monitor the baby during the actual cesarean delivery (technically difficult), the strategy is to maintain the blood pressure and cardiac output within the 20% of the baseline values."|intraoperatively during surgery||||percentage of patients|||Number
1341347|NCT01928771|Secondary|Patient and Clinician's Responder Assessment to Treatment|CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.|Immediately following the first administration of study drug through Study Week 48|Full analysis set, Baseline eosinophils >=300/uL|||Participants|||Number
1341348|NCT01928771|Secondary|Number of Participants That Utilized Health Care Resources||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300=/uL|||Participants|||Number
1341349|NCT01928771|Secondary|Mean Productivity Loss Due to Asthma in Classroom|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL who attending classes|||Percent of productivity loss||Standard Deviation|Mean
1341350|NCT01928771|Secondary|Mean Work Productivity Loss Due to Asthma|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL for patients who employed|||Percent of productivity loss||Standard Deviation|Mean
1341351|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in EQ-5D-5L VAS|EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
1341352|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in AQLQ(S)+12|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
1341353|NCT01928771|Secondary|Extend of Exposure|Extend of exposure is defined as duration of treatment in days|Immediately following the first administration of study drug through Study Week 48.|Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398.|||Days||Standard Deviation|Mean
1341369|NCT01928771|Secondary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL|||events/year||95% Confidence Interval|Least Squares Mean
1341354|NCT01928771|Secondary|Immunogenicity of Benralizumab|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive.|Pre-treatment until end of follow-up|Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398. However, data were only available for 402 patients in q.4, and 393 patients in q.8.|||Participants|||Number
1341355|NCT01928771|Secondary|Pharmacokinetics of Benralizumab|Mean PK concentrations at each visit|Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341356|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL|||Scores on a scale||Standard Deviation|Mean
1341357|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
1341358|NCT01928771|Secondary|Proportion of Night Awakening Due to Asthma|Change from baseline to Week 48 on proportion of night awakening due to asthma|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Proportion of nights||Standard Deviation|Mean
1341359|NCT01928771|Secondary|Home Lung Function Assessment Based on Evening PEF|Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF]|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||L/min||Standard Deviation|Mean
1341360|NCT01928771|Secondary|Home Lung Function Assessment Based on Morning PEF|Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF]|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||L/min||Standard Deviation|Mean
1341361|NCT01928771|Secondary|Change in Asthma Rescue Medication|Change from baseline to week 48 in number of rescue medication use (puffs/day)|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Puffs/day||Standard Deviation|Mean
1341362|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL|||Scores on a scale||Standard Deviation|Mean
1341363|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
1341364|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinopiles <300/uL|||Liter||Standard Deviation|Mean
1341365|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinopiles >=300/uL|||Liter||Standard Deviation|Mean
1341366|NCT01928771|Secondary|Time to First Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Days||95% Confidence Interval|Median
1341367|NCT01928771|Secondary|Number of Patients With >=1 Asthma Exacerbations||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Participants|||Number
1341368|NCT01928771|Secondary|Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations|The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||events/year||95% Confidence Interval|Least Squares Mean
1341862|NCT01923480|Secondary|Plasma Concentration of Ornithine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341370|NCT01928771|Primary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||events/year||95% Confidence Interval|Least Squares Mean
1341371|NCT01928693|Other Pre-specified|Number of Participants With Treatment Failure||29 days||||participants|||Number
1341372|NCT01928693|Other Pre-specified|Patient Pain Scores|Patients will be asked to grade the overall pain of the affected eye at each visit on a Scale= 0--None, 1- Mild, 2- Moderate, 3- Severe|Average of 6 times in a 29 day period||||units on a scale|||Number
1341373|NCT01928693|Other Pre-specified|Patient Satisfaction Scores|Patient satisfaction outcomes will be assessed using a series of survey questions ranging in both categorical and continuous outcomes. Treatment will be compared using either methods for differences in binomial proportions or the Wilcoxon Rank Sum test. Scale= 0- Very Comfortable, 1- Comfortable, 2- Uncomfortable, 3- Very Uncomfortable|Average of 6 times in a 29 day period||||units on a scale|||Number
1341374|NCT01928693|Other Pre-specified|Scarring|Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.|29 days||||millimeters|||Number
1341375|NCT01928693|Other Pre-specified|Time to Treatment Failure.|If there is no reduction in size of the corneal ulcer by day 8, the treatment will be deemed a failure and alternative medications will be given at the discretion of the investigator.|8 days|Data was not collected because there were no treatment failures in any of the treatment arms||||||
1341376|NCT01928693|Secondary|Healing Rate|Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.|29 days||||Days|||Number
1341377|NCT01928693|Primary|Complete Healing|The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.|29 days||||participant|||Number
1341378|NCT01928680|Secondary|Number and Severity of Adverse Events of Patients Enrolled in This Trial|Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.|1 year|||||||
1341379|NCT01928680|Secondary|Overall Survival||3 years|||||||
1341380|NCT01928680|Secondary|Progression Free Survival||2 years|||||||
1341381|NCT01928680|Primary|Overall Response Rate||6 months||||percentage of response|||Number
1341382|NCT01928615|Secondary|Percentage of Participants Preferring Each Injection Site|Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.|End of Cycle 14 (Week 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
1341383|NCT01928615|Secondary|Participant’s Satisfaction With the Injection Site|Each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
1341384|NCT01928615|Secondary|Health Care Provider’s Satisfaction With the Injection Site|The health care provider for each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
1341385|NCT01928615|Secondary|Disease-free Survival|Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
1341386|NCT01928615|Secondary|Overall Survival|Overall survival was defined as the time in months from Baseline to death from any cause.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
1341387|NCT01928615|Primary|Quality of Life Score|Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.|Cycles 7-14 (Weeks 19-42, 24 weeks total)|"Modified intent-to-treat population: All participants who received at least 1 dose of study medication and who have at least 1 quality of life score in each treatment period (Cycles 7-10 and Cycle 11-14).~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
1341388|NCT01928472|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 through Day 7 after each vaccination.|Analysis was done on the solicited safety set - All subjects in the exposed set with solicited AE data.|||Number of subjects|||Number
1341389|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.|Day 1 to Day 366.|Analysis was done on unsolicited safety set.|||Number of subjects|||Number
1341390|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 to Day 43|Analysis was done on unsolicited safety set - All subjects in the exposed set with unsolicited AE data.|||Number of subjects|||Number
1341391|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.|Day 183 and 366|FAS-Day 183 and FAS-Day 366|||Percentages of subjects||95% Confidence Interval|Number
1341392|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|"Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.~Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10."|Day 183 and 366|FAS-Day 183 and FAS-Day 366|||Percentages of subjects||95% Confidence Interval|Number
1341393|NCT01928472|Secondary|Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.|Day 183 and 366|FAS-Day 183 and FAS-Day 366|||Ratio||95% Confidence Interval|Geometric Mean
1341394|NCT01928472|Secondary|Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.|Day 183 and 366.|FAS-Day 183 and FAS-Day 366|||Titers||95% Confidence Interval|Geometric Mean
1341395|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.|Day 1 and 22.|FAS-Day 22|||Percentages of subjects||95% Confidence Interval|Number
1341396|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.~Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 22|FAS-Day 22|||Percentages of subjects||95% Confidence Interval|Number
1341397|NCT01928472|Secondary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.|Day 22|FAS-Day 22|||Ratio||95% Confidence Interval|Geometric Mean
1341398|NCT01928472|Secondary|Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)|Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.|Day 1 and 22|FAS-Day 22|||Titers||95% Confidence Interval|Geometric Mean
1341399|NCT01928472|Primary|Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.|Day 1 and 43|FAS-Day 43.|||Percentages of subejcts||95% Confidence Interval|Number
1341400|NCT01928472|Primary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.~Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 43|FAS-Day 43|||Percentages of subjects||95% Confidence Interval|Number
1341401|NCT01928472|Primary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.|Day 43|FAS-Day 43|||Ratio||95% Confidence Interval|Geometric Mean
1341402|NCT01928472|Primary|Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)|Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination|Day 1 and 43|The analysis was done on Full Analysis Set – Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).|||Titers||95% Confidence Interval|Geometric Mean
1341403|NCT01928433|Secondary|The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Participants Who Discontinued Due to TEAE|This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups.|Screening to day 24|Safety (SAF) population includes all subjects with at least one administration of study drug.|||Participants|||Count of Participants
1341419|NCT01928186|Secondary|Percentage Change in K1 (Blood Flow Parameter) by FLT PET|Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.|Baseline to up to 6 weeks||||% change||Full Range|Median
1341404|NCT01928433|Secondary|The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Treatment-emergent Adverse Events|This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups.|Screening to Day 24|Safety (SAF) population includes all subjects with at least one administration of study drug.|||Treatment-emergent AEs|||Number
1341405|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (Day 24).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 24|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
1341406|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 10|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
1341407|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 3|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
1341408|NCT01928433|Primary|Number of Participants With Clinical and Microbiological Response|"The primary endpoint of this study is the clinical and microbiological response of patients with cUTI or pyelonephritis to treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator at the Test of Cure (ToC) visit (Day 17) in the microbiological intent-to-treat population (micro-ITT population).~Clinical response is defined as resolution of the symptoms of cUTI present at trial entry and no new symptoms developed. Microbiological response is defined as elimination or reduction of study entry pathogens to ≤ 10e3 CFU/mL on urine culture. The clinical and microbiological response will be assessed for each group on Day 17 and will be compared between the three groups to assess the efficacy in each group."|Day 17|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
1341409|NCT01928381|Post-Hoc|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day home diary + in clinic assessment at end of 3 week treatment)|3 weeks of treatment|Per Protocol|||Average daily pain score||Standard Error|Least Squares Mean
1341410|NCT01928381|Primary|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)|3 weeks of treatment|Full Analysis set|||Average daily pain score||Standard Error|Least Squares Mean
1341411|NCT01928186|Other Pre-specified|Pre-treatment Gene Expression Levels|Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.|Baseline|||||||
1341412|NCT01928186|Other Pre-specified|Post-treatment Gene Expression Levels|Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.|1 to 6 weeks post-therapy start|||||||
1341413|NCT01928186|Secondary|Post-treatment Standardized Uptake Values (SUV) by FLT PET|FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET|1 to 6 weeks post-therapy start||||g/mL||Full Range|Median
1341414|NCT01928186|Secondary|Post-treatment FLT Transport (K1) Values by FLT PET|K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET|1 to 6 weeks post-therapy start||||mL/min/mL||Full Range|Median
1341415|NCT01928186|Secondary|Post-therapy Ki (Flux Constant) Values by FLT PET|Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET|1 to 6 weeks post-therapy start||||mL/min/mL||Full Range|Median
1341416|NCT01928186|Secondary|Baseline Standardized Uptake Values (SUV) by FLT PET|FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET|Baseline||||g/mL||Full Range|Median
1341417|NCT01928186|Secondary|Baseline FLT Transport (K1) Values by FLT PET|K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET|Baseline||||mL/min/mL||Full Range|Median
1341418|NCT01928186|Secondary|Baseline Ki (Flux Constant) Values by FLT PET|Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan|Baseline||||mL/min/mL||Full Range|Median
1341420|NCT01928186|Primary|Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens|"Tumor tissue samples from pre-treatment (baseline) biopsy and post-treatment surgery are stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.~The % values of positive cells from the baseline and post-treatment samples are then compared for each individual patient.~Association between Ki-67 and KFLT decline will be analyzed to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response."|Baseline to up to 6 weeks||||% change||Full Range|Median
1341421|NCT01928186|Primary|Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample|Surgically removed breast tumor tissue is stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.|1 to 6 weeks post-therapy start||||% stained cells||Full Range|Median
1341422|NCT01928186|Primary|Percent Change in SUV by FLT PET|Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.|Baseline to up to 6 weeks||||% change||Full Range|Median
1341423|NCT01928186|Primary|Percent Change in Net Influx Constant (Ki) by FLT PET|"Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.~Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher’s exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response."|Baseline to up to 6 weeks||||% change||Full Range|Median
1341424|NCT01928082|Other Pre-specified|Serum Procollagen Type 1 N-terminal Propeptide||4 weeks, 8 weeks|||||||
1341425|NCT01928082|Other Pre-specified|Serum C-telopeptides of Type 1 Collagen||4 weeks, 8 weeks|||||||
1341426|NCT01928082|Other Pre-specified|Serum Bone-specific Alkaline Phosphatase||4 weeks, 8 weeks|||||||
1341427|NCT01928082|Other Pre-specified|Serum Osteocalcin||4 weeks, 8 weeks|||||||
1341428|NCT01928082|Other Pre-specified|Serum Phosphorus||4 weeks, 8 weeks|||||||
1341429|NCT01928082|Other Pre-specified|Serum Parathyroid Hormone||4 weeks, 8 weeks|||||||
1341430|NCT01928082|Other Pre-specified|Serum 25 Hydroxyvitamin D||4 weeks, 8 weeks|||||||
1341431|NCT01928082|Other Pre-specified|Calculated Tubular Resorption of Calcium||4 weeks, 8 weeks|||||||
1341432|NCT01928082|Other Pre-specified|Calculated Serum Ionized Calcium||4 weeks, 8 weeks|||||||
1341433|NCT01928082|Other Pre-specified|Serum Total Calcium||4 weeks, 8 weeks|||||||
1341434|NCT01928082|Other Pre-specified|Serum Estradiol||4 weeks, 8 weeks|||||||
1341435|NCT01928082|Secondary|Serum Sclerostin||4 weeks, 8 weeks|||||||
1341436|NCT01928082|Secondary|Serum Bone Morphogenetic Protein 2||4 weeks, 8 weeks|||||||
1341437|NCT01928082|Secondary|Serum 1,25-dihydroxyvitamin D3|0 participants were analyzed because the study was terminated|4 weeks, 8 weeks|||||||
1341438|NCT01928082|Primary|Absolute Change in 24 Hour Urinary Calcium Excretion|0 participants were measured because the study was terminated|4 weeks, 8 weeks|0 participants were analyzed because the study was terminated||||||
1341439|NCT01928030|Secondary|Reduction in Forearm Volume|Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume|Up to 1 year|No participants received 900 units rHuPH20, and the MTD was not determined, so no participants received rHuPH20 at the MTD.|||Participants|||Count of Participants
1341440|NCT01928030|Primary|Treatment-related Adverse Events|Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment|Up to 1 year||||Participants|||Count of Participants
1341441|NCT01927887|Primary|Primary Efficacy Parameters of Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging. Specificity was determined by assessing the percentage of true negative nodes using pathology as a gold standard.|2 years||||percentage of true negative nodes||95% Confidence Interval|Number
1341442|NCT01927887|Primary|Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging|2 Years||||percentage of excised nodes||95% Confidence Interval|Number
1341443|NCT01927757|Secondary|Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.|Baseline, week 12 and week 24|"Full analysis set participants who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in each analysis."|||units on a scale||Standard Deviation|Mean
1341444|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 24|Full analysis set; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1341445|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 12|Full analysis set; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1341446|NCT01927757|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1341447|NCT01927757|Secondary|Percentage of Participants With DAS 28-CRP < 3.2|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity.|Weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1341448|NCT01927757|Secondary|Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity.|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1341449|NCT01927757|Secondary|Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100.~The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement."|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1341450|NCT01927757|Secondary|Percentage of Participants With an ACR 70 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
1341451|NCT01927757|Secondary|Percentage of Participants With an ACR 50 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
1341452|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 24|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
1341453|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
1341454|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
1341455|NCT01927757|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
1341456|NCT01927575|Secondary|Radiation Reduction|To assess if a reduction in radiation dose can be achieved in the TOMO group as compared to imaging standards with equal or better injury detection rates from TOMO imaging.|Baseline Imaging Collection|||||||
1341457|NCT01927575|Primary|This Outcome Measure is Reporting the Number of Participants for Whom Hip, Wrist, or Tibia Injury Was Detected Using the TOMO as Well as Standard X-Ray and Standard CT|Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid – where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) [or designee] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.|Baseline Imaging Collection|Three sets (1 - X-ray, 1- CT and 1 - Digital Tomosynthesis) of images of the tibia evaluated to confirm acceptable image quality and provided clinical and diagnostic value.|||participants|||Number
1341458|NCT01927419|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Select AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment to within 30 days past last dose|All participants who received at least 1 dose of study drug|||Participants|||Number
1341459|NCT01927419|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) Score|Health-related QOL was measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/quality of life composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 questionnaire, Version 3. The EORTC QLQ-C30 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool covering multiple items, including 5 functional scales (physical, role, emotional, social, and cognitive); 3 symptom scales (fatigue, nausea and vomiting, and pain); a global health status/QOL scale; and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for each item range from 0 to 100. A high score for a functional scale represents a high (healthy) level of functioning, and a high score for the global health status represents a high QOL. However, a high score for a symptom scale represents more severe symptoms.|From Baseline to Week 25|All randomized participants. n=number of participants evaluable|||Units on a scale||Standard Deviation|Mean
1341460|NCT01927419|Secondary|Percentage of BRAF Mutation-positive Participants With Investigator-assessed Objective Response|Objective Response is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR); percentage is determined by that total divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All BRAF mutation-positive participants|||Percentage of participants||95% Confidence Interval|Number
1341461|NCT01927419|Secondary|Investigator-assessed Progression-free Survival (PFS) in All Populations|PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, or death due to any cause, whichever occurs first. WT=wild type|Date of randomization to disease progression or death, whichever occurs first, to approximately 10 months|All randomized participants|||Months||95% Confidence Interval|Median
1341462|NCT01927419|Secondary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population|Objective Response Rate is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
1341534|NCT01926119|Secondary|Change in Motor Strength and Joint Range of Motion||End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline|This data was not collected and therefore not analyzed.||||||
1341535|NCT01926119|Secondary|Trophic Changes||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
1341463|NCT01927419|Primary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population|Objective Response Rate is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized BRAF wild-type patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized BRAF wild-type participants .|||Percentage of participants||95% Confidence Interval|Number
1341464|NCT01927120|Other Pre-specified|Rate of Natural Killer Cell (NK) Reconstitution|Investigators planned to monitor natural killer cell (NK) reconstitution. Standard immune deficiency flow cytometry panels (IDP) was to be drawn on days +90, +180, and +365 to evaluate NK reconstitution. Results of standard lab tests to be compared to compiled data at a later date|365 days post HCT|Lab test results to be compared to compiled data at a later date.||||||
1341465|NCT01927120|Other Pre-specified|Function of Blood Treg After Allogeneic HSCT|Percent of Treg suppression at day +30. Investigators had also planned to test Treg function at day +90, if sufficient Tregs had been available for analysis.|30 days post HCT|All evaluable participants at day +30.|||percentage of suppression||Standard Deviation|Median
1341466|NCT01927120|Secondary|STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 90|Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +90.|90 days post HCT|All participants.|||percentage in total CD4s||Full Range|Median
1341467|NCT01927120|Secondary|STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 30|Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +30.|30 days post HCT|All participants.|||percentage in total CD4s||Full Range|Median
1341468|NCT01927120|Secondary|Proportion of Treg Among Blood CD4+ T Cells at Day +90 After HCT|The proportion of Tregs to non-Treg CD4+ cells to be assessed at day +90. Natural Killer Cells (NKs): Median K/uL NK cells.|90 days post HCT|All participants.|||K/uL NK cells||Full Range|Median
1341469|NCT01927120|Secondary|Incidence of Unexpected or Serious Adverse Events (AEs)|Grade 3-5 unexpected or serious adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.03) were captured up to day +130 or 30 days after the last dose of IL-2. Events listed, with causality in relation to study treatment noted.|Up to days 130 post HCT|All participants.|||adverse events|||Number
1341470|NCT01927120|Secondary|Incidence of Non-relapse Death|Incidence of Non-relapse death/Transplant-related mortality. Non-relapse death is defined as death in continuous remission from primary disease requiring transplantation.|365 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
1341471|NCT01927120|Secondary|Cumulative Incidence of Chronic GVHD by Day +365|Cumulative incidence of chronic GVHD by day +365 per NIH Consensus criteria.|365 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
1341472|NCT01927120|Secondary|Cumulative Incidence of Grade II-IV Acute GVHD by Day +100|Acute GVHD will be graded per the 1995 consensus guidelines.|100 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
1341473|NCT01927120|Secondary|Cumulative Incidence of Relapse|Incidence of primary disease relapse per standard definitions.|1 year post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
1341474|NCT01927120|Secondary|Overall Survival at Day +365|Overall survival will be defined as the time from transplant date to death from any cause.|365 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
1341475|NCT01927120|Primary|Regulatory T Cells (Tregs)/Total CD4+ Cells at Day 30 Post-HCT|Percentage of Treg among blood CD4+ T cells at day 30 after hematopoietic cell transplantation (HCT), to compare to SIR/TAC alone data from a previous trial (median of 16%). The study was designed to capture an increase in regulatory T cells from a median of 16.0% at day +30.|30 days post HCT|All participants.|||percentage of CD4+Tregs||Full Range|Median
1341476|NCT01927055|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.|Change from Randomization to Week 1|"Patients entering the double-blind, randomized phase and having a visit at week 1 of the double-blind phase were analyzed.~Study was stopped when only 5% of planned participants had completed the study to prevent competition with FDA mandated post-marketing requirement study."|||units on a scale||Standard Deviation|Mean
1341477|NCT01926977|Secondary|Patients With Post Injection Pain Score of One or Higher on Pain Scale|Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)||||participants|||Number
1341478|NCT01926977|Primary|Evidence of Anterior Chamber Inflammation|Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)||||participants|||Number
1341479|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo A1 ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341536|NCT01926119|Secondary|Change in Sudomotor Function||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
1341537|NCT01926119|Secondary|Change in Vasomotor Function||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
1341538|NCT01926119|Secondary|Change in Sensory Perception||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
1341480|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo A1 ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341481|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo A1 ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341482|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo A1 ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341483|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
1341484|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
1341485|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
1341486|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
1341487|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|HDL-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341488|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|HDL-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1352855|NCT01762059|Other Pre-specified|Difference in the Percentage of Subjects With Mean CGMG <154mg/dl During the Closed-loop Period vs. the Usual Care Period||5 days||||percentage of subjects|||Number
1341489|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm|From Baseline to Week 24|HDL-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341490|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|HDL-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341491|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
1341492|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
1341493|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
1341494|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
1341495|NCT01926782|Secondary|Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
1341496|NCT01926782|Secondary|Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
1341497|NCT01926782|Secondary|Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|ITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
1341498|NCT01926782|Secondary|Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|ITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
1341499|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL(1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL(2.59 mmol/L) (With Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
1341500|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL(2.59 mmol/L) (Without Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
1341501|NCT01926782|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (With Concomitant Statin Therapy) at Week 24 - ITT Analysis|Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model. ITT population (subjects with or without concomitant statin therapy).|Up to Week 24|ITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
1341502|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL (Without Concomitant Statin Therapy) at Week 24 - ITT Analysis|Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model. ITT population (subjects with or without concomitant statin therapy).|Up to Week 24|ITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
1341503|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Total-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341504|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Total-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341505|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Non-HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Non-HDL-C ITT population (participants with concomitant statin therapy).|||percent change||Standard Error|Least Squares Mean
1341506|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Non-HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Non-HDL-C ITT population (participants without concomitant statin therapy).|||percent change||Standard Error|Least Squares Mean
1341507|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo B ITT population (participants with concomitant statin therapy).|||percent change||Standard Error|Least Squares Mean
1341508|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo B ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341509|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Total-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341510|NCT01926782|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Total-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341511|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C mITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341512|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C mITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341513|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341539|NCT01926119|Secondary|Change in Motor Function and Coordination|As assessed by functional capacity exam and physical exam|End of 5-day treatment series and at 1-week follow-up relative to baseline|This data was not collected and was therefore not analyzed.||||||
1341540|NCT01926119|Primary|Change in Pain|Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable|Baseline to post-TMS day 5|Completed 5 days of TMS|||units on a scale||Full Range|Mean
1341863|NCT01923480|Secondary|Plasma Concentration of Methionine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341514|NCT01926782|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341515|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B mITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341516|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B mITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341517|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341518|NCT01926782|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341519|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|mITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341520|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|mITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341521|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341522|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
1341523|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|mITT population|||percent change||Standard Error|Least Squares Mean
1341524|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Modified ITT (mITT) population (participants without concomitant statin therapy): all randomized and treated participants who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1341525|NCT01926782|Primary|Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis)|Adjusted least squares (LS) means and standard errors at Week 24 and at averaged Week 21 to 24 were obtained from a mixed effect model with repeated measures (MMRM) model to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in this model (ITT analysis). ITT population (subjects with concomitant statin therapy): all randomized subjects who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy): all randomized participants who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1341526|NCT01926782|Primary|Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 and at averaged Week 21 to 24 from MMRM including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects without concomitant statin therapy): all randomized subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy): all randomized participants who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1341527|NCT01926626|Other Pre-specified|Tolerability of Moclobemide + Nicotine Patch|Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.|||participants|||Number
1341528|NCT01926626|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.|The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).|Baseline and 1 week|Participants who received Moclobemide.|||percentage of change||Standard Error|Mean
1341529|NCT01926626|Other Pre-specified|Safety of Moclobemide + Nicotine Patch|"Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > moderate."|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.|||participants|||Number
1341530|NCT01926626|Secondary|Percentage of Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day||||percentage of change||Standard Error|Mean
1341531|NCT01926626|Secondary|Continuous Ten Week Abstinence From Smoking|Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.|10 weeks post quit day||||participants|||Number
1341532|NCT01926626|Secondary|Point Abstinence From Smoking at Six Months Post Quit|Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.|7 day point abstinence from smoking at six months post quit||||participants|||Number
1341533|NCT01926626|Primary|Continuous Four-week Abstinence From Smoking|Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).|Weeks 6-10 post quit day||||participants|||Number
1352856|NCT01762059|Other Pre-specified|Percentage of Subjects With Mean CGMG < 154mg/dl||5 days||||percentage of subjects|||Number
1341541|NCT01926028|Secondary|Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period|Als3-specific T-cell production of interleukin-17A will be measured by enzyme-linked immunospot (ELISpot) at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 90 days|All Participants|||Spot Forming Units||Standard Deviation|Geometric Mean
1341542|NCT01926028|Secondary|Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period|Als3-specific T-cell production of interferon gamma will be measured by enzyme-linked immunospot (ELISpot) at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 90 days|All participants|||Spot Forming Units||Standard Deviation|Geometric Mean
1341543|NCT01926028|Secondary|Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period|Cervicovaginal wash anti-Als3 IgA1 titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days|All participants|||Titer (dilution^-1)||Standard Deviation|Geometric Mean
1341544|NCT01926028|Secondary|Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period|Cervicovaginal wash anti-Als3 IgG titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days|All participants|||Titer (dilution^-1)||Standard Deviation|Geometric Mean
1341545|NCT01926028|Secondary|Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period|Serum anti-Als3 IgA1 titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days|All participants|||Titer (dilution^-1)||Standard Deviation|Geometric Mean
1341546|NCT01926028|Secondary|Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period|Serum anti-Als3 IgG titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days||||Titer (dilution^-1)||Standard Deviation|Geometric Mean
1341547|NCT01926028|Secondary|Time to First VVC Episode From Study Day 17 to 360 - All Participants|Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group|12 months|All participants|||Days||Inter-Quartile Range|Median
1341548|NCT01926028|Secondary|Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old|Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group|12 months|Participants < 40 years old|||Days||Inter-Quartile Range|Median
1341549|NCT01926028|Secondary|Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period|Number of patients with documented RVVC who were recurrence-free over the 12-month post-vaccination period in the NDV-3A vaccine group and the placebo group|12 months|All participants|||Participants|||Count of Participants
1341550|NCT01926028|Secondary|Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period|Number of patients <40 years old with documented RVVC who were recurrence-free over the 12-month post-vaccination period in the NDV-3A vaccine group and the placebo group|12 months|Participants <40 years old|||Participants|||Count of Participants
1341551|NCT01926028|Primary|Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period|Summary of injection site reactions for the safety population over the 12-months post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|12-month|All enrolled patients.|||AEs|AEs||Count of Units
1341552|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 3 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||NA Titer||95% Confidence Interval|Geometric Mean
1341553|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 2 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||NA Titer||95% Confidence Interval|Geometric Mean
1341554|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 1 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||NA Titer||95% Confidence Interval|Geometric Mean
1341555|NCT01926015|Secondary|Geometric Mean Titers for Pertussis FHA Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||EU/mL||95% Confidence Interval|Geometric Mean
1341556|NCT01926015|Secondary|Geometric Mean Titers for Pertussis Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||EU/mL||95% Confidence Interval|Geometric Mean
1341557|NCT01926015|Secondary|Geometric Mean Titers for Tetanus Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||IU/mL||95% Confidence Interval|Geometric Mean
1341558|NCT01926015|Secondary|Geometric Mean Titers for Diphtheria Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||IU/mL||95% Confidence Interval|Geometric Mean
1341559|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
1341560|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
1341561|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
1341562|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Fever|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
1341563|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event With Incidence >=1%|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded.|Up to 14 days after any of the 6 study visits|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was were counted only once overall.|||Percentage of participants|||Number
1341564|NCT01926015|Primary|Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3|Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer >=8.|4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||Percentage of participants|||Number
1341565|NCT01925781|Secondary|Point Prevalence Abstinence|No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.|12 weeks||||participants|||Number
1341566|NCT01925781|Primary|Sustained Abstinence|No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.|12 weeks||||participants|||Number
1341606|NCT01925404|Primary|Percentage Change in Park-based Physical Activity|Physical activity was measured in MET-hours (Metabolic equivalents)|difference between baseline and follow-up (1 year)|The unit of analysis was at the level of the park.|||Percent change in MET-hours|Parks|95% Confidence Interval|Mean
1341567|NCT01925768|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Start of the lst dose of IP to the end of the PBO controlled phase; Weeks 0-24 for those randomized to APR 30 mg; Weeks 0-24 for those randomized to PBO who did not enter EE at Week 16; Weeks 0-16 for those randomized to PBO who entered EE at Week 16|Safety population includes all participants who were randomized and received at least one dose of IP|||Participants|||Number
1341568|NCT01925768|Secondary|Change From Baseline in the Severity of Morning Stiffness at Weeks 52 and 104|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Weeks 52 and 104||2017-11-30|11/2017||||
1341569|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Weeks 52 and 104||2017-11-30|11/2017||||
1341570|NCT01925768|Secondary|Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Component Scores and Summary Score at Weeks 52 and 104|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Weeks 52 and 104||2017-11-30|11/2017||||
1341571|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Weeks 52 and 104||2017-11-30|11/2017||||
1341572|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Weeks 52 and 104|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Weeks 52 and 104||2017-11-30|11/2017||||
1341573|NCT01925768|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Weeks 52 and 104||2017-11-30|11/2017||||
1341574|NCT01925768|Secondary|Percentage of Participants Who Achieve an ACR 20 Response at Weeks 2, 4, 6, 8, 12 and 20|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and at Weeks 2, 4, 6, 8, 12 and 20||2017-11-30|11/2017||||
1341575|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Week 16||2017-11-30|11/2017||||
1341576|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Week 16|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Week 16||2017-11-30|11/2017||||
1341577|NCT01925768|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2.0 Physical Functioning Domain at Week 16|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16||2017-11-30|11/2017||||
1341578|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Week 16||2017-11-30|11/2017||||
1341579|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 16||2017-11-30|11/2017||||
1341580|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 24 Improved From Baseline|Morning stiffness severity was the participant’s assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Week 24||2017-11-30|11/2017||||
1341581|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Week 24|Morning stiffness was the participant’s assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A negative change from the baseline duration indicates an improvement.|Baseline and Week 24||2017-11-30|11/2017||||
1341582|NCT01925768|Secondary|Change From Baseline in the SF-36V2 Physical Component Summary Score at Week 24|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24||2017-11-30|11/2017||||
1341583|NCT01925768|Secondary|Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score Change at Week 24|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24||2017-11-30|11/2017||||
1341584|NCT01925768|Secondary|Change From Baseline in the 28-joint Disease Activity Score Using C-reactive Protein as the Acute-phase Reactant (DAS28 [CRP]) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement"|Baseline and Week 24||2017-11-30|11/2017||||
1341585|NCT01925768|Secondary|Percentage of Participants Who Achieve an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Week 24||2017-11-30|11/2017||||
1341586|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 24||2017-11-30|11/2017||||
1341704|NCT01924429|Primary|fMRI Reaction Time|Reaction-time, as measured by the reaction time test Go/No-Go Task as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder|up to 6 weeks||||ms||Standard Error|Mean
1341587|NCT01925768|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]); o Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS); o Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); o C-Reactive Protein (CRP)|Baseline and Week 16|FAS population consisting of all participants randomized as specified in the protocol; Those who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders. Non-responder imputation (NRI)|||percentage of participants|||Number
1341588|NCT01925703|Secondary|Serum Ferritin Level|Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All participants who achieved complete iron repletion for whom follow up data were available.|||nanograms per milliliter||95% Confidence Interval|Mean
1341589|NCT01925703|Secondary|Transferrin Saturation|Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow-up data were available.|||Percentage of transferrin saturation||95% Confidence Interval|Mean
1341590|NCT01925703|Primary|Serum Hemoglobin Concentration|Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow up data were available.|||grams per deciliter||95% Confidence Interval|Mean
1341591|NCT01925612|Secondary|Overall Survival|Median overall survival (in months) and observed minimum-maximum range.|Up to approximately 4 years||||Months||Full Range|Median
1341592|NCT01925612|Secondary|Progression-free Survival|Median progression-free survival (in months) and observed minimum-maximum range.|Up to approximately 4 years||||Months||Full Range|Median
1341593|NCT01925612|Secondary|Objective Response Rate|Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)|Up to 6 months||||Participants|||Count of Participants
1341594|NCT01925612|Primary|Incidence of Laboratory Abnormalities|Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.|Up to 6 months||||Participants|||Count of Participants
1341595|NCT01925612|Primary|Incidence of Adverse Events|Number (count) of participants that experienced at least 1 adverse event.|Up to 6 months||||Participants|||Count of Participants
1341596|NCT01925612|Primary|Complete Remission Rate|Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).|Up to 6 months||||Participants|||Count of Participants
1341597|NCT01925469|Secondary|Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.|The patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score|5 minutes||||mm||95% Confidence Interval|Median
1341598|NCT01925469|Secondary|Patient Satisfaction|The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.|30 minutes post procedure||||participants|||Number
1341599|NCT01925469|Primary|Change in Pain Score|The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups.|Pre-procedure (Baseline) and procedure (Time 0)||||mm||95% Confidence Interval|Median
1341600|NCT01925417|Secondary|Post-treatment Hospitalization Data|number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.|6 months|31 subjects had evaluable data at 6 months.|||number of particpants' ICU days||Full Range|Median
1341601|NCT01925417|Secondary|Quality of Life|Quality of life will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.|60 days|||||||
1341602|NCT01925417|Secondary|Absence of CDAD at 56 Days|Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.|56 days|31 subjects had evaluable data at 56 days.|||participants with treatment success|||Number
1341603|NCT01925417|Secondary|Long-term Safety|The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.|6 months|31 subjects had evaluable data at 6 months.|||number of reported SAEs|||Number
1341604|NCT01925417|Primary|Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660|Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.|56 days|31 subjects had evaluable data at 56 days.|||number of reported SAEs through 56 days|||Number
1341605|NCT01925404|Secondary|Park Use (% Change)|We will count the number of parks users and compare differences between the number counted at baseline to the number counted at follow-up|baseline versus 1 year|Participants were not assigned to study arms|||percentage change in park users|parks|95% Confidence Interval|Mean
1341607|NCT01925274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C)|Functional Assessment of Cancer Therapy-Colorectal (FACT-C) was used in this study to assess Health-Related Quality of Life (HRQoL) and CRC-related symptoms in participants enrolled to the randomized portion of the study. The FACT-C is part of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system, a comprehensive and extensive set of self-reported instruments for the assessment of health-related quality of life in participants with cancer or other chronic illnesses.|2 years|Data for this outcome measure were no longer collected after approval of protocol amendment 4, and data previously collected were insufficient to perform any analysis.||||||
1341608|NCT01925274|Secondary|Number of Participants With Expression of Pre-defined Gene Sequences in Biopsied Tumor Tissues|Pre-defined gene sequences were those related to EGFR, PI3K (phosphoinositide-3 kinase) and other oncogenic pathways; examples included but were not limited to PIK3CA (this gene encodes the catalytic subunit of PI3K), PIK3R1 (this gene encodes the regulatory subunit of PI3K), KRAS, NRAS and BRAF (this gene encodes serine/threonine-protein kinase B-Raf) sequences and PIK3CA gene amplification. Due to early termination of this study, these pre-defined gene sequences were not analyzed, except for KRAS and NRAS. Number of participants who had KRAS and NRAS wild type status confirmed by the central laboratory is presented.|2 years|All participants for whom at least one of these pre-defined gene sequences was analyzed were included.|||participants|||Number
1341609|NCT01925274|Secondary|Levels of Signaling Proteins in Paired and Single Tumor Biopsies|Pre defined signaling proteins included Akt (protein kinase B), p-Akt (phosphorylated Akt), p-S6 (phosphorylated ribosomal protein S6), p-Met (phosphorylated Met, a receptor tyrosine kinase), p-mTOR (phosphorylated mammalian target of rapamycin), EGFR (epithelial growth factor receptor), and p-EGFR (phosphorylated EGFR).|2 years|Data for this outcome measure were not collected due to early termination of this study.||||||
1341610|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of SN-38|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of SN-38 (an irinotecan metabolite) was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341611|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Irinotecan|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of irinotecan was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341612|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05212384|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of PF-05212384 was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341613|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of SN-38|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of SN-38 (an irinotecan metabolite) was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341614|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of Irinotecan|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of irinotecan was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341643|NCT01925209|Primary|Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52|The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 6MWD measurements were analyzed.|||meters||Standard Error|Least Squares Mean
1341615|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of PF-05212384|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of PF-05212384 was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1341616|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of SN-38|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Standard Deviation|Mean
1341617|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of Irinotecan|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Standard Deviation|Mean
1341618|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of PF-05212384|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Standard Deviation|Mean
1341619|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of SN-38|SN-38 is an irinotecan metabolite. Tmax of SN-38 was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Full Range|Median
1341620|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of Irinotecan|Tmax of irinotecan was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Full Range|Median
1341621|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of PF-05212384|Tmax of PF-05212384 was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Full Range|Median
1341622|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of SN-38|SN-38 is an irinotecan metabolite. Cmax of SN-38 was observed directly from data.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341623|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of Irinotecan|Cmax of irinotecan was observed directly from data.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341624|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of PF-05212384|Cmax of PF-05212384 was observed directly from data.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341644|NCT01925183|Primary|Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline (BL) to Follow-up week 12 (FU12)||||Participants|||Count of Participants
1341625|NCT01925274|Secondary|Number of Participants With ECG Maximum Increase From Baseline Meeting Pre-defined Criteria|"The number of participants with ECG maximum increase from baseline meeting the following criteria was reported:~Criterion A: maximum QTc interval increase from baseline >30 msec and ≤60 msec; criterion B: maximum QTc interval increase from baseline >60 msec; criterion C: maximum QTcB interval increase from baseline >30 msec and ≤60 msec; criterion D: maximum QTcB interval increase from baseline >60 msec; criterion E: maximum QTcF interval increase from baseline >30 msec and ≤60 msec; criterion F: maximum QTcF interval increase from baseline >60 msec."|2 years|QTc analysis set included all participants in the safety analysis set who had at least one ECG assessment after receiving study treatment.|||participants|||Number
1341626|NCT01925274|Secondary|Number of Participants With ECG Post-Baseline Maximum Absolute Values Meeting Pre-defined Criteria|The number of participants with ECG post-baseline maximum absolute values meeting the following criteria was reported: (1) maximum QTc interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (2) maximum QTcB (QT corrected for heart rate using Bazett’s formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (3) maximum QTcF (QT corrected for heart rate using Fridericia’s formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec.|2 years|QTc analysis set included all participants in the safety analysis set who had at least one ECG assessment after receiving study treatment.|||participants|||Number
1341627|NCT01925274|Secondary|Number of Participants With Laboratory Test (Coagulation) Abnormalities|Coagulation analysis included partial thromboplastin time (PTT) and international normalized ratio (INR) or prothrombin time (PT).|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
1341628|NCT01925274|Secondary|Number of Participants With Laboratory Test (Urinalysis) Abnormalities|Urinalysis included urine dipstick for protein and blood: if positive, perform a microscopic analysis. Number of participants with urine protein tested positive is presented.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
1341629|NCT01925274|Secondary|Number of Participants With Laboratory Test (Chemistry) Abnormalities|The following chemistry parameters were evaluated in this study: sodium, potassium, magnesium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, albumin, blood urea nitrogen (BUN) or urea, creatinine, total calcium, glycosylated hemoglobin (HbA1c), glucose, uric acid, phosphorus or phosphate, insulin, and C-peptide.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
1341630|NCT01925274|Secondary|Number of Participants With Laboratory Test (Hematology) Abnormalities|The following hematology parameters were evaluated in this study: hemoglobin, white blood cells (WBC) with differential, and platelets.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
1341631|NCT01925274|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) Grade|TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. CTCAE version 4.0 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.|Administration of the first dose of study drug through 28 calendar days after the last administration of study drug|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
1341632|NCT01925274|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE was defined as any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. AEs included both serious and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.|Administration of the first dose of study drug through 28 calendar days after the last administration of study drug|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
1341633|NCT01925274|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the duration from enrollment to death. Participants last known to be alive were censored at date of last contact.|2 years|Per protocol analysis set, i.e. all participants who were randomized, with KRAS and NRAS wild type status confirmed by central lab and with treatment arm assignment designated according to randomization. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm “PF 05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)”.|||months||95% Confidence Interval|Median
1341634|NCT01925274|Secondary|Duration of Response|For participants with an objective response (CR or PR), duration of response was defined as the time from first documentation of CR or PR to date of first documentation of objective progression or death. Date of first documentation of progression and date of first documentation of CR or PR were based on Investigator's assessment of response.|2 years|The analysis population included all participants who achieved CR or PR in Arm A and Arm B. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm “PF 05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)”.|||months||95% Confidence Interval|Median
1341645|NCT01925183|Primary|Proportion of Subjects With Sustained Virologic Response (SVR12)|Defined as HCV-RNA negativity by a sensitive assay|Follow-up week 12 (FU12)||||Participants|||Count of Participants
1341646|NCT01925170|Secondary|Biopsy Rate|Biopsy rate = number of participants who had a biopsy/number of number of participants analyzed.|12 months after mammography and MBI||||percentage of participants||95% Confidence Interval|Number
1341635|NCT01925274|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1. Confirmed PR was defined as disappearance of all target lesions. Confirmed PR was defined as >=30% decrease in sum of the longest dimensions of the target lesions taking the baseline sum as a reference. Confirmed responses were those that persisted on repeat imaging study >=4 weeks after initial documentation of response.|2 years|Response evaluable analysis set was used for the analysis of objective response, and it included all participants in the full analysis set (all participants who were randomized, with treatment arm assignment designated according to randomization) who had an adequate baseline assessment of disease and measurable disease.|||percentage of participants||95% Confidence Interval|Number
1341636|NCT01925274|Secondary|Number of Participants With Unacceptable Toxicity in Cycle 1 (Japanese LIC Only)|Unacceptable toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0) was any of the following occurrences: (1) Grade 4 neutropenia >7 days, or febrile neutropenia, or Grade 4 thrombocytopenia; (2) Grade >=3 nausea/vomiting despite optimal antiemetic treatment, or Grade >=3 diarrhea despite optimal anti diarrheal treatment; (3) unmanageable Grade >=3 hyperglycemia; (4) mean QTc interval (time from electrocardiogram [ECG] Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate) >501 msec in triplicate 12-lead ECG, or myocardial infarction, or ventricular arrhythmia; (5) Grade >=3 non-hematologic toxicity; (6) treatment delay of >=2 weeks due to study drug related toxicity; (7) persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses of both PF-05212384 and irinotecan during Cycle 1; (8) Grade >=2 respiratory toxicities.|28 days|The analysis population included all participants enrolled into Japanese LIC. As pre-specified in protocol, this outcome measure was not analyzed for reporting arms: “PF-05212384 + Irinotecan: Arm A” and “Cetuximab + Irinotecan: Arm B”.|||participants|||Number
1341637|NCT01925274|Primary|Progression Free Survival (PFS) as Assessed by Investigators|Progression-free survival (PFS) was the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Median PFS was estimated based on the Kaplan-Meier method.|From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|All participants who were randomized, with KRAS (Kirsten ras oncogene) and NRAS (neuroblastoma ras viral oncogene homolog) wild type status confirmed by central lab, and with treatment arm assignment designated according to randomization. As pre-specified in the protocol, this outcome measure was not analyzed for Japanese Lead-In Cohort.|||months||95% Confidence Interval|Median
1341638|NCT01925209|Secondary|Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52|The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.|||score on a scale||Standard Error|Least Squares Mean
1341639|NCT01925209|Secondary|Estimated Annual Number of Falls Per Patient Within Treatment Group|Participants documented any fall occurrences in a paper diary during the study.|Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.|||Annual number of falls per participant|||Number
1341640|NCT01925209|Secondary|Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52|Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 sIFA measurements were analyzed.|||score on a scale||Standard Error|Least Squares Mean
1341641|NCT01925209|Secondary|Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52|Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 QMT measurements were analyzed.|||newtons||Standard Error|Least Squares Mean
1341642|NCT01925209|Secondary|Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52|LBM was measured via dual energy x-ray absorptiometry (DXA) and calculated as (LBM at Week 52/LBM at baseline)*100 . A positive change from baseline indicates improvement.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 LBM measurements were analyzed.|||Percentage||95% Confidence Interval|Number
1341647|NCT01925170|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI.|12 months after mammography and MBI|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and MBI).|||percentage of participants||95% Confidence Interval|Number
1341648|NCT01925170|Secondary|Sensitivity for All Cancers Diagnosed|Sensitivity measures the percentage of actual positives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified cancer status at 12 months after the initial screening. 21 participants out of the total study population of 1585 were diagnosed with cancer.|||percentage of actual positives||95% Confidence Interval|Number
1341649|NCT01925170|Secondary|Specificity|Specificity measures the percentage of negatives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified negative cancer status at 12 months after the initial screening (mammography and MBI).|||percentage of true negatives||95% Confidence Interval|Number
1341650|NCT01925170|Primary|Cancer Detection Rate Per 1000 Women Screened, by Breast Density|The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.|Within 21 days of mammography||||cancers per 1000 women screened||95% Confidence Interval|Number
1341651|NCT01925144|Primary|PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1341652|NCT01925144|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
1341653|NCT01925144|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1341654|NCT01924975|Secondary|Time Required for Overall Successful Venous Cannulation.||10 minutes|Includes only those participants for which successful cannulation was achieved.|||Seconds||Inter-Quartile Range|Median
1341655|NCT01924975|Secondary|Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period.||10 minutes||||percent of participants|||Number
1341656|NCT01924975|Primary|Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation||10 minutes||||percent of participants|||Number
1341657|NCT01924949|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1341658|NCT01924949|Secondary|HCV RNA Change From Baseline||Baseline; Weeks 1, 4, and 8|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1341659|NCT01924949|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 weeks|Full Analysis Set|||percentage of participants|||Number
1341660|NCT01924949|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1341661|NCT01924949|Primary|Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1341662|NCT01924949|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1341663|NCT01924871|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.|||||||
1341664|NCT01924871|Secondary|Success Rate & Complication Rate Including Cough|We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.|assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.|||||||
1341665|NCT01924871|Primary|Awakening Time|The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening|Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.||||minutes||Inter-Quartile Range|Median
1341666|NCT01924845|Secondary|Number of Participants With Non-Serious AEs|Number of participants with non-serious Adverse Events. Data is taken at final time point of Week 24, compared to baseline. For full AE data, please see AE section.|Baseline through Week 24 +4 weeks follow-up|Full Analysis Set.|||Participants|||Count of Participants
1341667|NCT01924845|Secondary|Percent Predicted Upright Forced Vital Capacity (FVC)|Pulmonary function test: Percent Predicted Upright Forced Vital Capacity|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Percent Predicted||Standard Deviation|Mean
1341752|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|5 years||2019-12-31|12/2019||||
1341669|NCT01924845|Secondary|Percent Predicted Maximum Expiratory Pressure (MEP)|Pulmonary function test: Percent Predicted Maximum Expiratory Pressure|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Percent Predicted||Standard Deviation|Mean
1341670|NCT01924845|Primary|Percent Predicted Maximum Inspiratory Pressure (MIP)|Pulmonary function test: Percent Predicted Maximum Inspiratory Pressure|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Percent Predicted||Standard Deviation|Mean
1341671|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for Emax0-5, Emax0-12, Emin0-5 and Emin0-12.~Emax: Maximum effect (maximum measured concentration of glucose or insulin in plasma) & Emin: Minimum effect (minimum measured concentration of glucose or insulin in plasma)"|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS|||µU/mL||Standard Deviation|Mean
1341672|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for AUEC0-5 and AUEC0-12. AUEC0-5: The area under the effect concentration-time curve over the time interval 0 to 5.~AUEC0-12: The area under the effect concentration-time curve over the time interval 0 to 12."|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS|||µU*h/mL||Standard Deviation|Mean
1341673|NCT01924767|Secondary|Fasting Plasma Glucose|Percentage change from baseline to Day 8 in fasting plasma glucose. Baseline is defined as Day -2.|-0:30 (Pre dose samples)|PDS|||percentage of fasting plasma glucose||Standard Deviation|Mean
1341674|NCT01924767|Secondary|Mean Daily Glucose|Change from baseline to Day 8 in mean daily glucose. Baseline is defined as Day -2.|0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8|PDS|||mg/dL||Standard Deviation|Mean
1341675|NCT01924767|Secondary|Change From Baseline to Day 8 in Urinary Glucose Excretion|Change from baseline to day 8 in urinary glucose excretion. Baseline is defined as Day -2.|-2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8|Pharmacodynamic (PD) analysis set (PDS) contains of all patients who received study medication and have evaluable pharmacodynamic parameter data.|||mg||Standard Deviation|Mean
1341676|NCT01924767|Secondary|Accumulation Ratios|"Accumulation ratio based on Cmax (RA,Cmax) and Accumulated ratio based on AUC0-tau (RA,AUC) at steady-state.~Accumulation ratio for the respective doses were calculated using below mentioned equations:~RA,Cmax = Cmax,ss/Cmax~RA,AUC= AUCtau,ss/AUCtau"|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1341677|NCT01924767|Secondary|Linearity Index|The linearity index is defined as AUC0-tau divided by AUC0-∞ both at steady state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||Fraction||Geometric Coefficient of Variation|Geometric Mean
1341678|NCT01924767|Secondary|Peak Trough Fluctuation|Peak trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||PTF(%) of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
1341679|NCT01924767|Secondary|Apparent and Renal Clearance of the Analyte in Plasma|"Apparent clearance of the analyte in plasma (CL/F) after first dose and at steady-state, Renal clearance of the analyte in plasma after extravascular administration (CLR) after first dose and at steady-state.~Apparent clearance after first dose is defined as the dose divided by AUC0-∞; apparent clearance at steady-state is defined as the dose divided by AUC0-tau at steady-state.~Renal clearance CLR(0-t) is defined as Ae0-t divided by AUC0-t."|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1341680|NCT01924767|Secondary|Fraction of Analyte Excreted Unchanged in Urine|"Fraction of analyte excreted unchanged in urine in the time interval 0 to 12 h (fe0-12) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-12 by the Dose and multiply it with 100.~Fraction of analyte excreted unchanged in urine in the time interval 0 to 24 h (fe0-24) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-24 by the Dose and multiply it with 100."|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set|||percent of analyte||Geometric Coefficient of Variation|Geometric Mean
1341681|NCT01924767|Secondary|Amount of Analyte Eliminated in Urine|Amount of analyte that is eliminated in urine after first dose and at steady state from the time interval 0 to 24 h (Ae0-24) and 0 to 48 h (Ae0-48)|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set|||nmol||Geometric Coefficient of Variation|Geometric Mean
1341682|NCT01924767|Secondary|Apparent Volume of Distribution During the Terminal Phase|Apparent volume of distribution during the terminal phase (Vz/F) after first dose and at steady state. Apparent volume is defined as CL/F divided by the terminal rate constant in plasma (either after first dose or at steady-state).|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||L||Geometric Coefficient of Variation|Geometric Mean
1341753|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 years||2019-12-31|12/2019||||
1341683|NCT01924767|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half life of the analyte in plasma (t1/2) and mean residence time of the analyte in the body after single oral administration (MRTpo) after first dose and at steady-state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK Set|||h||Geometric Coefficient of Variation|Geometric Mean
1341684|NCT01924767|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||1/h||Geometric Coefficient of Variation|Geometric Mean
1341685|NCT01924767|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of the analyte in plasma (tmax) after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||h||Full Range|Median
1341686|NCT01924767|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)|AUC0-∞: from 0 extrapolated to infinity after first dose AUCtau,1: over a uniform dosing interval tau after first dose AUCtau,ss: over a uniform dosing interval tau at steady-state AUCs were computed using the linear up/log down algorithm. If an analyte concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was to be used. If the analyte concentration was smaller than the preceding concentration, the logarithmic method was to be used.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1341687|NCT01924767|Secondary|Concentration of the Analyte in Plasma|Maximum concentration of the analyte in plasma (Cmax) after first dose, Maximum, minimum (Cmin) and average (Cavg) concentration of the analyte in plasma at steady-state, Concentration of analyte in plasma at 24 h after administration of the 8th dose (at steady-state) (C24,8)|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|Pharmacokinetic set (PK set) contains of all patients who received study medication and have evaluable pharmacokinetic parameter data. The PK set will not contain placebo patients.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1341688|NCT01924767|Primary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.|day 21|Treated set|||percentage of participants|||Number
1341689|NCT01924767|Primary|Micturition Frequency|Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.|Baseline and Day 9|Treated set|||frequency of micturition||Standard Deviation|Mean
1341690|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results|Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results|day 1 to day 21|Treated set|||percentage of participants|||Number
1341691|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests|Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|day 1 to day 21|Treated set.|||percentage of participants|||Number
1341692|NCT01924559|Primary|Time to Successful Intubation|Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute|approximately one minute|EM Residents who tested/participated in each of the six groups|||seconds||Full Range|Mean
1341693|NCT01924429|Secondary|CGI-S|CGI-S: Severity of impairment due to ADHD was measured by the Clinical Global Impressions-Severity scale (CGI-S). Lower scores indicate less severe impairment from symptoms, with a CGI-I=1 indicating the person is “normal” with no impairment. (1= normal, not ill, 2= minimally ill, 3= mildly ill, 4= moderately ill, 5=markedly ill, 6=severely ill, 7= very severely ill)|baseline||||units on a scale||Standard Deviation|Mean
1341694|NCT01924429|Secondary|CGI-I|Clinical Global Impressions – CGI-I: Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).|Baseline||||units on a scale||Standard Deviation|Mean
1341695|NCT01924429|Secondary|ADHD-Inattentive|ADHD symptoms and severity - subscale for Inattentiveness. 9-item scale, each scored 0-3, with total from 0 to 27. Higher score indicates higher level of inattentiveness.|4 weeks and 8 weeks||||units on a scale||Standard Deviation|Mean
1341696|NCT01924429|Secondary|ADHD-RS-IV Combined Sum|ADHD symptoms and severity. Norm referenced interview to assess severity and frequency of ADHD symptoms. 18 Items are scored 0-3 to reflect severity and frequency of ADHD symptoms, and a sum is taken. Full range from 0 to 54, with higher number indicating more symptoms and severity.|Baseline||||units on a scale||Standard Deviation|Mean
1341697|NCT01924429|Secondary|WRAADS|"The Wender-Reimherr adult attention deficit disorder scale (WRAADS): Symptom measure for emotional functioning/lability, generally reported as Sum of Responses (0-2 per item, higher = more impaired).~For this outcome measure, Average scores for particular questions were taken - specifically question 3, question 4, and question 5."|Baseline||||units on a scale||Standard Deviation|Mean
1341698|NCT01924429|Secondary|ASRS - Expanded|ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).|at 4 weeks|not collected||||||
1341699|NCT01924429|Secondary|ASRS - Expanded|ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).|at one week|not collected||||||
1341705|NCT01924429|Primary|The Go/No-Go Task Percentage Assessed by fMRI|Performance Measures on the Go/No-Go Task assessed by fMRI as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder. The Go/No-Go Task is a neuropsychological test that provides a direct measure of number of responses made that are “correct” or “incorrect”. It is not a scale. Reported are the percentage of correct responses on that direct performance measure. 0% correct is worse than 100% correct.|8 weeks|Performance measures are done while participants are off drug and while on drug.|||percentage correct responses/inhibitions||Standard Error|Mean
1341706|NCT01924390|Other Pre-specified|Change in Ridge Width and Ridge Height|Ridge width and height are measured at time of tooth extraction & grafting, and again 18-20 weeks later at time of implant placement. Changes in ridge height and width are determined.|At time of implant placement, which is 18-20 weeks after grafting of extraction socket||||change in ridge width (loss of width mm)||Standard Deviation|Mean
1341707|NCT01924390|Secondary|Percent Residual Graft Material and Percent Connective Tissue|Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue|18-20 weeks||||percentage of residual graft||Standard Deviation|Mean
1341708|NCT01924390|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|18-20 weeks||||percentage of vital bone||Standard Deviation|Mean
1341709|NCT01924364|Secondary|Adipose Stem Cell Yield Per Volume of Fat Tissue|this describes the biologic properties of the cells within the fat graft|Surgical visit||||%age of cells yield/volume of fat tissue||Standard Deviation|Mean
1341710|NCT01924364|Primary|Total Fat Volume Injected and Facial Volume Postop|Facial appearance and persistence of treatment effect will be assessed using high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.|Surgical visit, PO Study visits month 3, month 9, month 12, and month 24||||mL||Standard Deviation|Mean
1341711|NCT01924299|Primary|PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
1341712|NCT01924299|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
1341713|NCT01924299|Primary|PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Cmax of baricitinib.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1341714|NCT01924299|Primary|PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1341715|NCT01924299|Primary|PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1341716|NCT01924299|Primary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1341717|NCT01924182|Other Pre-specified|Sleep Assessment|Compare changes from Baseline to Month 3 between the IT group and CMM group for Apnea-Hypopnea Index (AHI). The AHI was collected via overnight sleep lab polysomnography. The AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI values for adults are categorized as Normal: AHI<5, Mild sleep apnea: 5≤AHI<15, Moderate sleep apnea: 15≤AHI<30, Severe sleep apnea: AHI≥30. For each subject, the change in AHI will be calculated as the AHI at Month 3 minus the AHI at Baseline. A negative change value represents a lowering of the subjects AHI (an improvement, or reduction in sleep apnea).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the outcome assessment, no statistical analysis will be presented.|||units on a scale||Standard Deviation|Mean
1341718|NCT01924182|Secondary|Opioid-Related Side Effects|Summarize the changes from Baseline to Month 3 between the IT group and CMM group in Common Terminology Criteria for Adverse Events (CTCAE) toxicity score. (from the National Cancer Institute) A subset of 23 specific items of the CTCAE v4.03 were evaluated. The subset was chosen as these criteria were most related to opioid side effects that are of interest in this study. The investigator scored the assessment at each visit. The total score for a visit is based on the sum of 23 individual CTCAE’s. The individual scales have a range of 0 to 2, 0 to 3, or 0 to 5 and the total score ranges from 0 (best case) to 90 (worst case). For each subject, the change in toxicity will be calculated as the total toxicity score at Month 3 minus the total toxicity score at Baseline. A negative change value represents a lowering of the subjects toxicity score (an improvement, or reduction in toxicity).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the secondary outcome assessment, no statistical analysis will be presented.|||units on a scale||Standard Deviation|Mean
1341719|NCT01924182|Secondary|Pain Assessment|Compare changes from Baseline to Month 3 between the IT group and CMM group in Numeric Pain Rating Scale (NPRS). The scale measures pain intensity. Using NPRS, a pain score ranging from 0 (no pain) to 10 (pain as bad as you can imagine) is recorded on a subject diary twice daily for 5 days before a study visit. The score for each visit is calculated as the mean pain of the 5 diary days morning and evening scores. For each subject, the change in pain will be calculated as the mean pain score at Month 3 minus the mean pain score at Baseline. A negative change value represents a lowering of the pain score (an improvement, or reduction in pain).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the secondary outcome assessment, no statistical analysis will be presented.|||units on a scale||Standard Deviation|Mean
1341720|NCT01924182|Primary|Clinical Success|Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the primary outcome assessment, no statistical analysis will be presented.|||participants|||Number
1341721|NCT01924169|Secondary|Seroconversion Response|Study considered positive in regard to the secondary endpoints if seroconversion is observed in 60% or more of the subjects for at least one of the vaccinations given.|4 weeks after flu vaccine administered|The first three participants did not remain on study long enough to undergo immunizations.||||||
1341722|NCT01924169|Primary|Number of Participants With IgG Response|IgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.|6 months||||Participants|||Count of Participants
1341723|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 13||||percentage of inappropriate behaviors||Inter-Quartile Range|Median
1341724|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder’s hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 1||||percentage of inappropriate behaviors||Inter-Quartile Range|Median
1341725|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 13|All subjects completed up to meal 13.|||percentage of bites||Inter-Quartile Range|Median
1341726|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ‘‘show me’’; gestural: ‘‘show me like this’’ plus modeling opening the mouth; physical: ‘‘show me’’ plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 1||||percentage of bites||Inter-Quartile Range|Median
1341727|NCT01923805|Primary|Transfusion Requirements|The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.|Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.|Data were not collected from participants enrolled in the study||||||
1341728|NCT01923740|Secondary|Distal Late Loss (LL)|"Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup.~Distal is defined as within 5 mm of healthy tissue distal to the device placement."|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341729|NCT01923740|Secondary|Proximal Late Loss (LL)|"Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup.~Proximal is defined as within 5 mm of healthy tissue proximal to the device placement."|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341730|NCT01923740|Secondary|In-Device Late Loss (LL)|In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341731|NCT01923740|Secondary|In-Segment Late Loss (LL)|In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341732|NCT01923740|Secondary|Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percentage of participants|Target lesions||Number
1341733|NCT01923740|Secondary|Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percentage of participants|Target lesions||Number
1341734|NCT01923740|Secondary|Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percentage of participants|Target lesions||Number
1341771|NCT01923740|Secondary|Number of Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|4 years||2019-12-31|12/2019||||
1341735|NCT01923740|Secondary|Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||percentage of participants|Target lesions||Number
1341736|NCT01923740|Secondary|Distal Percent Diameter Stenosis (%DS)|"The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method."|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
1341737|NCT01923740|Secondary|Proximal Percent Diameter Stenosis (%DS)|"The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method."|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
1341738|NCT01923740|Secondary|In-Device Percent Diameter Stenosis (%DS)|"The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method."|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
1341739|NCT01923740|Secondary|In-Segment Percent Diameter Stenosis (%DS)|The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
1341740|NCT01923740|Secondary|Distal Minimum Lumen Diameter (MLD)|Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341741|NCT01923740|Secondary|Proximal Minimum Lumen Diameter (MLD)|Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.|At 1 year|Per-Treatment-Evaluable Population (PTE) Population. Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341742|NCT01923740|Secondary|In-Device Minimum Lumen Diameter (MLD)|Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341743|NCT01923740|Secondary|In-Segment Minimum Lumen Diameter (MLD)|"Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.~INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent."|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341744|NCT01923740|Secondary|Number of Participants With Overall Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|0 to 1095 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341745|NCT01923740|Secondary|Number of Participants With Overall Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|731 to 1095 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341813|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 37days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341746|NCT01923740|Secondary|Number of Participants With Overall Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|0 to 730 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341747|NCT01923740|Secondary|Number of Participants With Overall Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|366 to 730 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341748|NCT01923740|Secondary|Number of Participants With Overall Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|0 to 365 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341749|NCT01923740|Secondary|Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|31 to 365 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341750|NCT01923740|Secondary|Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|>1 to 30 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341751|NCT01923740|Secondary|Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|< or = 1 day|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1352857|NCT01762059|Secondary|Difference of Outcome Measures on Day 1 vs. Remaining Days (Days 2-5) During the Closed-loop Period.||5 Days|Data were not collected||||||
1341754|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341755|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341756|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341757|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341758|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341759|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341760|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341761|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years||2019-12-31|12/2019||||
1341762|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years||2019-12-31|12/2019||||
1341763|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341764|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341765|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341766|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341767|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341768|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341769|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|≤ 7 days post index procedure (In-hospital)|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341770|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|5 years||2019-12-31|12/2019||||
1352858|NCT01762059|Secondary|Number of Hypoglycemic Episodes During Exercise.||5 days|Data were not collected||||||
1341772|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341773|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341774|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 393 Days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341775|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341776|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341777|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341778|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341779|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|5 years||2019-12-31|12/2019||||
1341780|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|4 years||2019-12-31|12/2019||||
1341781|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341782|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341783|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341784|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341785|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341786|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341787|NCT01923740|Secondary|Number of Participants Experienced All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341788|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment|5 years||2019-12-31|12/2019||||
1341789|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|4 years||2019-12-31|12/2019||||
1341814|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341790|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341791|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341792|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 393 Days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341793|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341794|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341795|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341796|NCT01923740|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341797|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|5 years||2019-12-31|12/2019||||
1341798|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|4 years||2019-12-31|12/2019||||
1341799|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341800|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341815|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|5 years||2019-12-31|12/2019||||
1341816|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|4 years||2019-12-31|12/2019||||
1352859|NCT01762059|Secondary|Mean BG During Exercise.||5 days|Data were not collected||||||
1341801|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341802|NCT01923740|Secondary|Number of Participants Experieced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341803|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341804|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341805|NCT01923740|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341806|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|5 years||2019-12-31|12/2019||||
1341807|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|4 years||2019-12-31|12/2019||||
1341808|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341809|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341810|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 393 Days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341811|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 298 Days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341812|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341864|NCT01923480|Secondary|Plasma Concentration of Lysine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341818|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341819|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341820|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341821|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341822|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341823|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341824|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|5 years||2019-12-31|12/2019||||
1341825|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|4 years||2019-12-31|12/2019||||
1341826|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341827|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341828|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341829|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341830|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341831|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341832|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341833|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|5 years||2019-12-31|12/2019||||
1341834|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|4 years||2019-12-31|12/2019||||
1341835|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341836|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341837|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341838|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341839|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341840|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 37 days|Per-Treatment-Evaluable Population. Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341841|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341842|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma"|5 years||2019-12-31|12/2019||||
1341843|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years||2019-12-31|12/2019||||
1341844|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 1123 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341845|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 758 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1341846|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 393 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341847|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341865|NCT01923480|Secondary|Plasma Concentration of Leucine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341848|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341849|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 37days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341850|NCT01923740|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
1341851|NCT01923740|Secondary|Number of Participants With Acute Procedural Success|"Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success.~Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only."|At time of procedure up to 7 days in hospital|ITT set. Four subjects (Absorb BVS (1) arm and XIENCE V arm (3)) were excluded from the data analysis for acute success. During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts. Data from these 5 subjects (3 in the Absorb BVS arm and 2 in the XIENCE V arm) were excluded from all data analyses.|||Participants|||Count of Participants
1341852|NCT01923740|Secondary|Acute Device Success|"Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.~Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only."|< or = 1 day|"Intent to treat set (ITT). Four subjects (1 in the Absorb BVS arm and 3 in the XIENCE V arm) were excluded from the data analysis for acute success.~During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts,3 in the Absorb BVS arm and 2 in the XIENCE V arm were excluded from all data analyses."|||Percentage of target lesions|Target lesions||Number
1341853|NCT01923740|Primary|In-segment Late Loss (LL) - Per Lesion Analysis|In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
1341854|NCT01923740|Primary|In-segment Late Loss (LL) - Per Subject Analysis|In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.|At 1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter||Standard Deviation|Mean
1341855|NCT01923480|Secondary|Plasma Concentration of Valine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341856|NCT01923480|Secondary|Plasma Concentration of Tyrosine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341857|NCT01923480|Secondary|Plasma Concentration of Threonine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341858|NCT01923480|Secondary|Plasma Concentration of Taurine||Three times during each 7 hour visit|No data available as no data for this outcome measure were collected during the study.||||||
1341859|NCT01923480|Secondary|Plasma Concentration of Serine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341860|NCT01923480|Secondary|Plasma Concentration of Proline||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
1341874|NCT01923480|Secondary|Plasma Stable Isotope Enrichment of Tyrosine||Twelve times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.|||trace/tracee ratio||Standard Deviation|Mean
1341875|NCT01923480|Secondary|Plasma Stable Isotope Enrichment of Phenylalanine||Twelve times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.|||trace/tracee ratio||Standard Deviation|Mean
1341876|NCT01923480|Secondary|Serum Concentration of Insulin||Five times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, serum concentration of insulin was not collected at any time point during Period 1. One subject in grp 0.08 g/kg/hr, seq AB, serum concentration of insulin was not collected at the 3hr time point during Period 2.|||mciu/mL||Standard Deviation|Mean
1341877|NCT01923480|Secondary|Plasma Concentration of Glucose||Nine times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, plasma concentration of glucose was not collected at any time point during Period 1.|||mg/dL||Standard Deviation|Mean
1341878|NCT01923480|Secondary|Insulin Sensitivity||Five times during each 7 hour visit|No data available as no data for this outcome measure were collected during the study.||||||
1341879|NCT01923480|Primary|Change in Net Protein Synthesis||One time at pre-clinisol infusion and one time at post-clinisol infusion|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||g protein/d/kg ffm||Standard Deviation|Mean
1341880|NCT01923467|Primary|Acceptance of Offer to Join Stop Smoking Program|After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.|1 Day of Enrollment||||participants|||Number
1341881|NCT01923389|Secondary|Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Rac for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
1341882|NCT01923389|Secondary|Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|t1/2 for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
1341883|NCT01923389|Secondary|Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|CL for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
1341884|NCT01923389|Secondary|Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Tmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
1341885|NCT01923389|Secondary|Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cav for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not reported due to the premature termination of the study.||||||
1341886|NCT01923389|Secondary|Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cmin for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.||||||
1341887|NCT01923389|Secondary|Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|Cmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.||||||
1341888|NCT01923389|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|AUCtau for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.||||||
1341889|NCT01923389|Primary|Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.|Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.|Days 1 up to the last follow-up (Day 68)|All participants who received at least 1 dose of active study medication (PF-05231023). Neutralizing antibodies were not tested because all participants who received PF-05231023 100 mg tested negative for anti-PF-05231023 antibodies.|||Participants|||Number
1341890|NCT01923389|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
1341891|NCT01923389|Primary|Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia’s formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
1341987|NCT01922037|Secondary|Total Number of Asthma Exacerbations During Months 7-12|An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma exacerbations||Standard Deviation|Mean
1341892|NCT01923389|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
1341893|NCT01923389|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.|Day -7 through the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
1341894|NCT01923311|Secondary|Adherence to EVG|Adherence was calculated as the number of pills taken divided by number of pills prescribed multiplied by 100.|Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)|Safety Analysis Set|||percentage of pills||Standard Deviation|Mean
1341895|NCT01923311|Secondary|Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group||Up to Week 48|Palatability was only to be assessed for participants taking EVG suspension formulation. As no participants were dosed with the EVG oral suspension formulation, no data are available on its palatability.||||||
1341896|NCT01923311|Secondary|Age of First Menses|Age of first menses for female participants.|Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL)|Participants in the Safety Analysis Set with available data were analyzed. Age of First Menses for participants ages 6 to < 12 years with screening HIV-1 RNA < 50 copies/mL was not analyzed because none of the participants reached their first menstruation cycle during or prior to the study.|||years||Standard Deviation|Mean
1341897|NCT01923311|Secondary|Tanner Stage Evaluation by Sex at Week 48|Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 48 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).|Week 48|Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants.|||Participants|||Count of Participants
1341898|NCT01923311|Secondary|Tanner Stage Evaluation by Sex at Week 24|Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 24 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).|Week 24|Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants.|||Participants|||Count of Participants
1341899|NCT01923311|Secondary|Change From Baseline in CD4 Percentage at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days).|||percentage (%)||Standard Deviation|Mean
1341900|NCT01923311|Secondary|Change From Baseline in CD4 Percentage at Week 24||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days).|||percentage (%)||Standard Deviation|Mean
1341901|NCT01923311|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||cells/uL||Standard Deviation|Mean
1341902|NCT01923311|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||cells/uL||Standard Deviation|Mean
1341903|NCT01923311|Secondary|Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||Log₁₀ copies/ mL||Standard Deviation|Mean
1341904|NCT01923311|Secondary|Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||Log₁₀ copies/mL||Standard Deviation|Mean
1341905|NCT01923311|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
1341906|NCT01923311|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
1341907|NCT01923311|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
1341908|NCT01923311|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
1341909|NCT01923311|Secondary|Pharmacokinetic (PK) Parameter: Vz/F of EVG|Vz/F is defined as the apparent volume of distribution of the drug.|Predose and up to 12 hours postdose on Day 10|Participants in the Intensive PK Analysis Set: EVG with available data were analyzed.|||mL||Standard Deviation|Mean
1341910|NCT01923311|Secondary|Pharmacokinetic (PK) Parameter: CL/F of EVG|CL/F is defined as the apparent oral clearance following administration of the drug.|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis set (EVG)|||mL/h||Standard Deviation|Mean
1341911|NCT01923311|Secondary|Pharmacokinetic (PK) Parameter: Ctau of EVG|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis Set (EVG)|||ng/mL||Standard Deviation|Mean
1341912|NCT01923311|Primary|Percentage of Participants Experiencing Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject. The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).|Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)|Safety Analysis Set|||percentage of participants|||Number
1341913|NCT01923311|Primary|Percentage of Participants Experiencing Treatment-emergent Adverse Events||Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)|Safety Analysis Set|||percentage of participants|||Number
1341914|NCT01923311|Primary|Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10|Cmax is defined as the maximum concentration of drug.|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis Set (EVG)|||ng/mL||Standard Deviation|Mean
1341915|NCT01923311|Primary|Pharmacokinetic (PK) Parameter: AUCtau of EVG|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis Set(EVG): all enrolled participants who received at least 1 dose of study drug and for whom steady-state pharmacokinetic profiles of the analyte of interest at the Intensive PK(Day 10) visit were evaluable.Includes 12 participants with screening HIV-1 RNA<50 copies/mL and 2 participants with screening HIV-1 RNA>1000 copies/mL.|||h*ng/mL||Standard Deviation|Mean
1341916|NCT01922986|Secondary|Change in Motricity Index|"Measures strength in finger pinch, elbow flexion and arm abduction. 0 No pinch movement. 11 Slight movement of finger or thumb. 19 Able to grip the cube, but not hold it against gravity. 22 Able to grip and hold the cube against gravity, but not against a weak pull by examiner.~The weighted score based on the ordinal 6 point scale 26 Able to grip and hold the cube against a weak pull, but weaker than the other side.~33 Normal pinch grip.~For shoulder and elbow scoring is:~0 No movement. 9 Palpable contraction in muscle, but no movement. 14 Visible movement, but not full range and not against gravity. 19 Full range of movement against gravity but not against resistance. 25 Full movement against resistance, but weaker than the other side. 33 Normal power. Maximum total score is 99, minimum is 0. Changes that are positive signify improved strength at postte"|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).||||units on a scale||Standard Deviation|Mean
1341917|NCT01922986|Secondary|Change in Finger Tracking Test|This test involves placing a device on the hand that shows the changing angle of the finger joint on a computer screen as the joint is moved. The computer screen also shows a target line, such as a sine wave. At the start of the test, the computer screen cursor moves horizontally across the target and the subject moves the finger joint into extension or flexion to adjust the vertical position of the cursor to that it traces the target line as accurately as possible. The performance is quantified by calculating the root-mean-square error between the target line and the response line. This is converted into an Accuracy Index, which has a maximum value of 100% (perfect score). Negative values can occur and reach a value of -100%, signifying very poor performance. Typical scores for healthy range from 50-80%. Typical values in stroke range from -100 to +40%. Changes that are positive signify increased tracking accuracy at posttest compared to pretest, which would be an improvement.|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).||||units on a scale||Standard Deviation|Mean
1341918|NCT01922986|Primary|Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores|This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).||||percentage of change from baseline||Standard Deviation|Mean
1341919|NCT01922934|Primary|Health Care Utilization - Laboratory Measurements|Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of number of lab measurements taken during the period (including A1C, creatinine, and lipids).|1 year study period||||Number of measurements||95% Confidence Interval|Least Squares Mean
1341920|NCT01922934|Secondary|Documentation of Obesity|"To assess:~Presence of ICD-9 code for obesity in the DHHA registry Control Group~Evidence of a specific intervention for weight management resembling what was offered in the toolbox intervention: weight loss medication prescribed, gym membership, weight loss program or referral to wt loss specialist, and meal replacements"|1 year study period|Random sample of 120 patient medical records from the DHHA registry Control Group with recorded BMI > or = to 30 plus one comorbidity|||Participants|||Count of Participants
1341921|NCT01922934|Primary|Health Care Utilization - Non-study Clinic Visits|Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of non-study clinic visits.|1 year study period||||Number of visits||95% Confidence Interval|Least Squares Mean
1341922|NCT01922934|Primary|Percentage of Participants Who Achieved >5% Weight Loss at 12 Months|Participants who had both a baseline and 12 month weight measurement were included. Weight change at 12 months was measured as a percent difference from their starting weight.|1 year||||percentage of participants|||Number
1341923|NCT01922739|Secondary|Percentage of Participants Withdrawn From the Study For Lack of Efficacy|Percentage of patients who withdrew from the study for lack of efficacy, as indicated on the early termination form of the case report form (CRF).|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|Safety Analysis Set|||percentage of participants|||Number
1341924|NCT01922739|Secondary|Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit|"The API was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their average pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control.~Endpoint refers to the last observation carried forward."|Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period|Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.|||units on a scale||Standard Deviation|Mean
1341925|NCT01922739|Secondary|Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit|"The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. At each visit, participants selected the number that best described their worst pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control.~Endpoint refers to the last observation carried forward."|Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period|Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.|||units on a scale||Standard Deviation|Mean
1341926|NCT01922739|Primary|Participants With Clinically Significant (CS) Hearing Changes From Baseline to the Final Visit in Pure Tone Audiometry Test Results|Pure tone audiometry was performed by trained personnel. Hearing loss was classified in degrees of hearing from normal to profound. This classification was determined by the hearing threshold (or the softest sound detected at a specific frequency). The exact ranges that classified hearing loss depended on the exact technique used during testing and on the patient's age. These values were provided by each audiology laboratory that performed the test. For serial audiograms, the criteria for a clinically significant hearing change were based on guidance from the American Speech Language Hearing Association (ASHA 1994, cited in [Konrad-Martin et al 2005]). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to “no response” at 3 consecutive test frequencies.|Baseline was within two weeks of the final study visit in study 3103; during study exam was within two weeks of the end of trial visit for study 3104 (up to study week 26)|Safety Analysis Set|||Participants|||Count of Participants
1341927|NCT01922739|Primary|Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings|"A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period [or early termination]). A qualified physician at the study center was responsible for providing interpretation of the ECG.~Endpoint refers to the last observation carried forward."|Baseline (final visit for study 3103), End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|Post-Titration Safety Analysis Set. Includes participants who have both baseline and endpoint data.|||Participants|||Count of Participants
1341928|NCT01922739|Primary|Participants With Shifts From Normal to Abnormal in Physical Examination Findings|The endpoint visit or early termination visit was an abbreviated exam. Endpoint refers to the last observation carried forward.|End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|Post-Titration Safety Analysis Set|||Participants|||Count of Participants
1341929|NCT01922739|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline vital sign result are counted as part of the number of participants analyzed.|||Participants|||Count of Participants
1341930|NCT01922739|Primary|Participants With Potentially Clinically Significant Abnormal Laboratory Values|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase (AST): >=3* upper limit of normal (ULN)~Alkaline phosphatase: >=3* upper limit of normal (ULN)~Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN)~Serum white blood cells: >=20 * 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Eosinophils: >=10.0 %~Platelets: <=75 * 10^9/L~Absolute neutrophils: <=1.0 * 10^9/L~Urinalysis: Glucose, Ketones, and Total Protein: >=2 unit increase from baseline"|End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline result for each test are counted as part of the number of participants analyzed for that test.|||Participants|||Count of Participants
1341931|NCT01922739|Primary|Participants With Adverse Events|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|Safety Analysis Set for the Titration/Adjustment period; Post-Titration/Post-Adjustment Safety Analysis Set for the Open-Label Treatment Period|||Participants|||Count of Participants
1341932|NCT01922349|Secondary|RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
1341933|NCT01922349|Secondary|RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS|||Ratio of Cmax||Geometric Coefficient of Variation|Geometric Mean
1341934|NCT01922349|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||hours||Geometric Coefficient of Variation|Geometric Mean
1341935|NCT01922349|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1341936|NCT01922349|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||hours||Full Range|Median
1341937|NCT01922349|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1341938|NCT01922349|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)|Terminal half-life of the analyte in plasma after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|PKS|||hours||Geometric Coefficient of Variation|Geometric Mean
1341939|NCT01922349|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1342901|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
1341940|NCT01922349|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1341941|NCT01922349|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)|Time from dosing to maximum measured concentration in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||hour||Full Range|Median
1341942|NCT01922349|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|maximum measured concentration of the analyte in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1341943|NCT01922349|Primary|Number (%) of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.|Up to 21 days (4 days for SRD period and 17 days for MRD period)|Treated set (TS)|||Percentage of participants|||Number
1341944|NCT01922271|Secondary|Inspiratory Capacity (IC)|Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
1341945|NCT01922271|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
1341946|NCT01922271|Secondary|Residual Volume (RV)|Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
1341947|NCT01922271|Secondary|Functional Resistance Capacity (FRCpleth)|Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
1341948|NCT01922271|Secondary|Specific Airway Resistance (sRAW)|Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||kilopascal (kPa)||Standard Deviation|Mean
1341949|NCT01922271|Secondary|Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||liters per hour||Standard Deviation|Mean
1341950|NCT01922271|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2|Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||liters per hour||Standard Deviation|Mean
1341951|NCT01922219|Secondary|Final Score on the Hamilton Depression Rating Scale|"Final score on the Hamilton Depression Rating Scale (HDRS) was calculated for 37 patients who were treated with Cognitive Behavioral Therapy.~The 17-item HDRS is a clinician-administered scale that quantifies depression severity, and includes items assessing mood, suicidal thinking, insomnia, feelings of guilt, work and activities, somatic symptoms, and insight. It is a well-characterized scale with excellent psychometric properties. The total score is the sum of the individual scores of the 17 scale items. Higher scores indicate greater depression severity. When using this outcome measure, we covary for baseline HDRS scores. Published norms for interpretation of the 17-item HDRS use a different version of the scale with a total possible score of 52, and are listed below. Interpretation is comparable (but not identical) with the 17-item HDRS version used in this study, which has a maximum score is 51.~None: 0-7 Mild: 8-13 Moderate: 14-19 Severe: 20-25 Very Severe: 26-52"|Post-Treatment, up to 12 weeks||||units on a scale||Standard Deviation|Mean
1341988|NCT01922037|Secondary|Total Number of Asthma Exacerbations During Months 1-6|An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.|Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma exacerbations||Standard Deviation|Mean
1342850|NCT01908829|Secondary|Change From Baseline in Post Void Residual (PVR) Volume|PVR Volume was assessed by bladder scan.|Baseline and weeks 4, 8 & 12|The analysis population consisted of the SAF with data available at each time point.|||mL||Standard Deviation|Mean
1341952|NCT01922219|Secondary|Post-Treatment Beck Depression Inventory|"The Beck Depression Inventory is a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression.~The scale measures symptoms related to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex.~We report the total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression. The following score interpretations are provided in the scale’s manual:~0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression"|Post-Treatment, up to 12 weeks||||Score on a scale||Standard Deviation|Mean
1341953|NCT01922219|Primary|Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10|The primary outcome of this study is remission from depression at the conclusion of 12 weeks of cognitive behavioral therapy for depression. This will be assessed using the Beck Depression Inventory, a self-report questionnaire of symptoms of depression that will be administered at every treatment visit. Remission is defined by a final Beck Depression Inventory score less than or equal to 10.|12 weeks||||Participants|||Count of Participants
1341954|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.|Week 4||||percentage of total correct||Standard Deviation|Mean
1341955|NCT01922115|Secondary|Overactive Bladder Questionnaire|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes.|Week 4||||units on a scale||Standard Deviation|Mean
1341956|NCT01922115|Secondary|Mini–Mental State Examination|The mini–mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes.|Week 4||||units on a scale||Standard Deviation|Mean
1341957|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.|Week 4||||units on a scale||Standard Deviation|Mean
1341958|NCT01922089|Secondary|Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).|Tolerability was assessed as the number of participants who achieved LCZ696 200 mg bid and maintained this dose for at least 2 weeks before study completion, regardless of previous dose interruption or down-titration and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||participants|||Number
1341959|NCT01922089|Secondary|Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Treatment success was defined as the number of participants who achieved and maintained LCZ696 200 mg bid without any dose interruption or down-titration over 12 weeks and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||participants|||Number
1341960|NCT01922089|Primary|Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Full Analysis Set (FAS) consisted of all randomized patients with the exception of mis-randomized patients who had not received the study drug, but had been inadvertently randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||participants|||Number
1341989|NCT01922037|Primary|Total Number of Asthma Exacerbations During Months 1-12|An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma exacerbations||Standard Deviation|Mean
1352860|NCT01762059|Secondary|Difference of Outcome Measures on Days 1-2 vs. on Remaining Days (Days 3-5) During the Closed-loop Period.||5 Days|Data were not collected||||||
1341961|NCT01922037|Secondary|Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score|The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.|Baseline, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1341962|NCT01922037|Secondary|Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant|Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by participant, is reported.|EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
1341963|NCT01922037|Secondary|Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator|Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.|EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
1341964|NCT01922037|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score|WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1341965|NCT01922037|Secondary|Change From Baseline in Asthma Control Test (ACT) Overall Score|Multidimensional factors associated with asthma control from the participant’s perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.|Baseline, Months 3, 6, 9, 12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1341966|NCT01922037|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score|AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants’ asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1341967|NCT01922037|Secondary|Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications|Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant’s study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.|Baseline until EOS/ET (up to Month 12)|All enrolled participants.|||percentage of participants|||Number
1341968|NCT01922037|Secondary|Percentage of Participants With Prior Asthma Medications by Category or Class of Medications|Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.|Baseline|All enrolled participants.|||percentage of participants|||Number
1341969|NCT01922037|Secondary|Change From Baseline in Percentage Predicted FEV1 (ppFEV1)|FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of predicted FEV1||Standard Deviation|Mean
1341970|NCT01922037|Secondary|Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%−75%)|FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||liters per second||Standard Deviation|Mean
1341971|NCT01922037|Secondary|Change From Baseline in Raw Forced Vital Capacity (FVC)|FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||liters||Standard Deviation|Mean
1341972|NCT01922037|Secondary|Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.|Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||liters||Standard Deviation|Mean
1341973|NCT01922037|Secondary|Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids|Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
1341974|NCT01922037|Secondary|Percentage of Participants by Number of Asthma Exacerbations|Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
1341975|NCT01922037|Secondary|Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related telephone calls||Standard Deviation|Mean
1341976|NCT01922037|Secondary|Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related telephone calls||Standard Deviation|Mean
1341977|NCT01922037|Secondary|Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related telephone calls||Standard Deviation|Mean
1341978|NCT01922037|Secondary|Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related physician's office visits||Standard Deviation|Mean
1341979|NCT01922037|Secondary|Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related physician's office visits||Standard Deviation|Mean
1341980|NCT01922037|Secondary|Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related physician's office visits||Standard Deviation|Mean
1341981|NCT01922037|Secondary|Total Number of Asthma-Related ER Visits During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related ER visits||Standard Deviation|Mean
1341982|NCT01922037|Secondary|Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related ER visits||Standard Deviation|Mean
1341983|NCT01922037|Secondary|Total Number of Asthma-Related ER Visits During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related ER visits||Standard Deviation|Mean
1341984|NCT01922037|Secondary|Total Number of Asthma-Related Hospital Admissions During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related hospital admissions||Standard Deviation|Mean
1341985|NCT01922037|Secondary|Total Number of Asthma-Related Hospital Admissions During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related hospital admissions||Standard Deviation|Mean
1341990|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 4 to 5 Hours After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
1341991|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 2 to 3 Hours After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
1341992|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 15 Minutes to 1 Hour After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
1341993|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
1341994|NCT01922011|Other Pre-specified|Change From Baseline in Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments|Focused neurological examinations include assessments of alertness, sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk, and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose), and tremor of the hands/fingers.|Baseline and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|Data were only summarized for each visit; but not analyzed.||||||
1341995|NCT01922011|Other Pre-specified|Concentration of Serum Creatine Kinase (CK)|Serum was collected at Baseline and at End of Therapy IV, from which the concentration of CK was determined.|Baseline and End of Therapy IV (up to Day 42)|Treated participants based on the treatment received|||U/L||Standard Deviation|Mean
1341996|NCT01922011|Other Pre-specified|Number of Participants With 1 or More Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that at any dose results in death; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.|Administration of first dose through the last follow-up visit; an expected time of up to 6.5 months|Treated participants based on the treatment received|||Participants|||Number
1341997|NCT01922011|Other Pre-specified|Number of Participants With 1 or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, clinically significant laboratory finding, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|Administration of first dose up to approximately six and a half months after last dose of study drug|Treated participants based on the treatment received|||Participants|||Number
1341998|NCT01922011|Secondary|Percentage of Participants With a Favorable Microbiological Response Categorized by Baseline Pathogen at Test of Cure|Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. For a favorable microbiological response, the outcome for each baseline pathogen must be eradicated or presumed eradicated. Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.|Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.|||Percentage of participants||95% Confidence Interval|Number
1341999|NCT01922011|Secondary|Percentage of Participants With Sustained Clinical Improvement|Sustained clinical improvement was defined as participants with clinical improvement who further met the definition of clinical cure. Clinical improvement was in the three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. The EOT visit is within 48 hours of last dose of PO therapy.|Baseline (within 48 hours prior to first dose of IV study drug) - up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen; and had non-missing clinical outcome.|||Percentage of participants||95% Confidence Interval|Number
1342009|NCT01921829|Other Pre-specified|Adverse Events|Hypokalemia (K <3.0 milliequivalents (mEq)/L), hypotension (systolic BP <90 mmHg), hyponatremia (Na <130 mEq/L), arrhythmias, cramps, and other (recorded as short description).|Daily while in hospital , 1 mo, & 3 mos||||events||Standard Deviation|Mean
1342017|NCT01921829|Secondary|PHQ-9 Depression Index Change at 1 Month|"The Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scores range from 0-27 with increasing scores representing increasing depression severity. Score categories represent depression severity and management recommendations:~0-4 - Minimal or no depression. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination.~20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination."|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
1342000|NCT01922011|Secondary|Percentage of Participants With a Clinical Cure Categorized by Baseline Pathogen at Test of Cure|At Test Of Cure (TOC) clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further antibacterial therapy is required. Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. To have a favorable microbiological response, the outcome for each participant's baseline pathogen must be favorable (eradicated or presumed eradicated). Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.|Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.|||Percentage of participants||95% Confidence Interval|Number
1342001|NCT01922011|Secondary|Percentage of Participants With a Favorable Clinical Outcome|Favorable clinical outcomes are clinical recovery and clinical cure. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. Clinical recovery is defined as clinical improvement in the composite end point three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5, and no development of new symptoms of AHO; body temperature ≤ 38°C (100.4°F) for 24 hours; no new or additional bone or joint infection (e.g., abscess, spreading to other osseous or articular locations) such that no further antibacterial therapy or surgery are required; no hematogenous metastatic infection (e.g., abscess in liver, spleen, lung; other bones) or bacteremia.. The End of Therapy (EOT) visit is within 48 hours of last dose of PO therapy.|Baseline (within 48 hours prior to first dose of IV study drug) - and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen|||Percentage of participants||95% Confidence Interval|Number
1342002|NCT01922011|Secondary|Percentage of Participants With Clinical Improvement Measured as a Composite End Point of Pain, Inflammation, Limb Function, Body Temperature, and C-reactive Protein at End-of IV (EOIV) Therapy Visit.|A participant had a favorable outcome in this composite endpoint if all 3 of the following criteria were met: Clinical improvement in the general symptom categories of Pain, Inflammation, and Limb Function on or before Study Day 5; Body temperature ≤ 38°C (100.4°F) over the preceding 24 hours; and C-reactive Protein (CRP) decreased from baseline for participants who had a baseline CRP >ULN (upper limit of normal)) or remain <=ULN for participants who had a baseline <=ULN on or before Study Day 5. The EOIV visit is within 24 hours after the last dose of IV study drug and before switch to optional open label (PO) therapy, if applicable.|Up to study Day 5|All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen and who did not have all clinical assessments performed at the time point.|||Percentage of participants||95% Confidence Interval|Number
1342003|NCT01922011|Primary|Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories.|Clinical improvement was based on the Investigator’s overall assessment of severity of each of the 3 general symptom categories of Pain, Inflammation, and Limb Function. Based on this evaluation, a participant was considered to have met criteria for clinical improvement according to the following definition: If 3 general categories are present at baseline: at least a 1-point improvement (i.e. severe to moderate, moderate to mild, mild to absent) in at least 2 of the general categories and no worsening in the other. If 2 general categories are present at baseline: at least a 2-point improvement (i.e. severe to mild, moderate to absent) in at least 1 of the general categories and no worsening or new findings in the others OR at least a 1-point improvement in both and no new findings in the other. If 1 general category is present at baseline: at least a 2-point improvement (i.e., severe to mild, moderate to absent) in that category and no new findings in the others.|Up to study Day 5|All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen.|||Percentage of participants||95% Confidence Interval|Number
1342004|NCT01921894|Primary|Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation|The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation|4 weeks|The characteristics of the study population are the same as described for the other primary outcome (vitamin D sufficiency at 8 weeks)|||participants|||Number
1342005|NCT01921894|Secondary|Number of Participants With FEV1 < 80% of Predicted|Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).|8 weeks|We wanted to compare the proportion of subjects whose FEV1 % predicted fell below 80% predicted across the three arms in this pilot Phase I study.|||participants|||Number
1342006|NCT01921894|Secondary|Number of Participants With Elevated Urinary Calcium/Creatinine Ratio|Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation|4 and/or 8 weeks|We wanted to compare the proportion of subjects who had an elevated UCa/UCr ratio across the three groups in this pilot Phase I Study|||participants|||Number
1342007|NCT01921894|Secondary|Number of Participants With Vitamin D Toxicity|Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37)|8 weeks|We wanted to report and compare the proportion of subjects who had vitamin D toxicity, hypercalcemia or an elevated UCa/UCr ratio across the three treatment arms|||participants|||Number
1342008|NCT01921894|Primary|Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation|The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation|8 weeks|In this pilot study, we wanted to report and compare the proportion of subjects who achieved vitamin D sufficiency after 8 weeks of treatment with one of three vitamin D doses.|||participants|||Number
1342010|NCT01921829|Secondary|PSQI Total Score Change at 3 Months|The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5–10 minutes to complete. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0–3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1342011|NCT01921829|Secondary|PHQ-9 Depression Index Change at 3 Months|"The Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scoring ranges from 0-27 with increasing scores representing increasing depression severity. Score categories determine depression severity and recommended management:~0-4 - Minimal or none. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination.~20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination."|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1342012|NCT01921829|Secondary|SF-36 Physical Component Score (PCS) Change at 3 Months|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1342013|NCT01921829|Secondary|SF-36 Mental Component Score (MCS) Change at 3 Months|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1342014|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 3 Months|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1342015|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 3 Months|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1342016|NCT01921829|Secondary|PSQI Total Score Change at 1 Month|The Pittsburgh Sleep Quality Index (PSQI) is the most widely used global sleep assessment and has been studied in the renal transplant population. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0–3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
1342030|NCT01921751|Secondary|Correlation Between SMAD4 Status Determined by Immunohistochemistry (IHC) and Genetic SMAD4 Status||Baseline|Because the study was terminated early, genetic SMAD4 status was not determined and therefore this analysis will not occur.||||||
1342018|NCT01921829|Secondary|SF-36 Physical Component Score (PCS) Change at 1 Month|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
1342019|NCT01921829|Secondary|SF-36 Mental Component Score (MCS) Change at 1 Month|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
1342020|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 1 Month|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
1342021|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 1 Month|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
1342022|NCT01921829|Secondary|Acute Kidney Injury|Acute kidney injury will be defined based a rise in Cr ≥0.3 mg/dL.|Daily while in hospital, 1 mo & 3 mos||||Participants|||Count of Participants
1342023|NCT01921829|Secondary|Fluid Balance|Strict intake (oral intake, intravenous medications, fluids, etc.) and output (urine, emesis, stools, drains, etc.) will be documented by the nurses on the HF floors per routine clinical protocol for all patients. Fluid balance will be determined by subtracting the volume of total intake from the volume of total output (in mL) over 24 hours (7 am to 7 am or the preceding 24-h period if no 7 am to 7 am period is available). Fluid balance and urine output will be ascertained by chart review daily during the intervention while the participants are hospitalized.|Daily while in hospital||||mL/day||Standard Deviation|Mean
1342024|NCT01921829|Secondary|Difference From Baseline to 1 Month in Change in Right Internal Jugular Vein (RIJV) Cross-sectional Area (CSA) Pre- and Post-Valsalva|The change in cross-sectional area (CSA) of the right internal jugular vein (RIJV) pre- and post-Valsalva is a measurement of venous compliance and was determined noninvasively with Doppler ultrasound. An increase in RIJV CSA >17% during Valsalva effectively rules out elevated right atrial pressure (RAP) and suggests effective volume removal or decongestion. The difference between baseline and 1 month values of change in RIJV CSA are reported.|Up to 1 month (measured at baseline and 1 mo)||||cm^2||Standard Deviation|Mean
1342025|NCT01921829|Secondary|All-cause Mortality|All-cause mortality will be ascertained based on chart review of vital status (alive/dead) and cause of death.|Up to 3 months (assessed at 1 month and 3 months)||||Participants|||Count of Participants
1342026|NCT01921829|Secondary|Number of Total Rehospitalizations|Number of rehospitalizations will be ascertained based on chart review of admissions to any hospital after the index hospitalization|Up to 3 months (assessed at 1 month and 3 months)||||hospitalizations||Standard Deviation|Mean
1342027|NCT01921829|Secondary|Number of Rehospitalizations for Heart Failure (HF)|Number of rehospitalizations for HF will be ascertained based on chart review of admissions with HF as a coded diagnosis, evidence of clinical volume overload, and treatment with intravenous diuretics.|Up to 3 months (assessed at 1 month and 3 months)||||hospitalizations|||Number
1342028|NCT01921829|Secondary|Length of Hospitalization|Length of hospitalization will be ascertained from admission date to date of discharge.|1 month|One participant from the ProDiuS arm withdrew consent before undergoing any randomized treatment.|||days||Standard Deviation|Mean
1342029|NCT01921829|Primary|Change in Body Weight (kg) From Randomization to Day 4 or Date of Discharge (Whichever Comes First)|The change in body weight (kg) from randomization to day 4 or date of discharge will be determined by the difference between body weight at day 4 after randomization or date of discharge (whichever comes first) and body weight taken at baseline measured in the hospital on standard scales without shoes and wearing a hospital gown, measured before breakfast and post-voiding.|4 days (96 hours)|One patient from ProDiuS arm withdrew before undergoing any randomized treatment.|||kg||Standard Deviation|Mean
1342031|NCT01921751|Secondary|Patterns of Failure (Local and Metastatic Failure)|Local progression is defined as least a 20% increase in the sum of diameters of the primary, taking as reference the baseline sum. Given the inherent inaccuracy in determining size of a primary pancreatic carcinoma, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and progression must be demonstrated on at least two sequential scans. Metastatic failure is defined as metastatic disease. Local and distant failure were to be estimated by the cumulative incidence method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients with failure is reported.|From randomization until last follow-up. Maximum follow-up at time of study termination was 8.3 months.|Randomized eligible patients with follow-up data.|||Participants|||Count of Participants
1342032|NCT01921751|Secondary|Overall Survival Within SMAD4 Subsets|"Survival time is defined as time from randomization to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported. Patients are categorized by SMAD4 status of intact (positive nuclear labeling is observed of the neoplastic cells ), loss (no labeling observed of the neoplastic cells) , or undetermined (insufficient material for immunostaining or results are equivocal). This study terminated early with only 20 registered (346 planned) and 13 randomized (288 planned). There are no proven results as to which category has better incomes, but this study hypothesizes that intact is highly correlated with local failures and loss is highly correlated with widespread metastasis, in which case intact would correspond with positive results relative to loss."|From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.|All randomized patients|||Participants|||Count of Participants
1342033|NCT01921751|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported.|From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.|All randomized patients|||Participants|||Count of Participants
1342034|NCT01921452|Primary|Concentration of TSH in Whole Blood||Day 1 up to Day 5|The FAS included all enrolled participants.|||Milli international units per liter||Standard Deviation|Mean
1342035|NCT01921452|Primary|Number of Participants With Positive and Negative TSH Test Result||Day 1 up to Day 5|The FAS included all enrolled participants. ‘n’ signifies number of participants who were evaluable for this measure for the specified category.|||Participants|||Number
1342036|NCT01921348|Other Pre-specified|Immune Biomarkers|Changes in Regulatory T(Treg), Type 1 Regulatory T (Tr1), T helper 3(TH3), T helper 1(TH1), T helper 2(TH2)cells, salivary cortisol, alpha amylase, Interferon gamma(IFNg), Interleukin 4(IL4) and Interleukin 10(IL10) cytokine production from baseline to 8 weeks.|8 weeks|Blood samples were collected and frozen for batch analysis, but not analyzed for data since recruitment goals were not met.||||||
1342037|NCT01921348|Secondary|Psychological Measures|Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.|8 weeks|Since the immune biomarker frozen blood samples were not analyzed (due to not meeting recruitment goals), the effects of ear accupressure based upon psychological differences could not be analyzed.||||||
1342038|NCT01921348|Primary|Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only)|"RQLQ is an instrument that has 28 items in 7 domains (sleep, non-rhinoconjuctivitis symptoms, practical problems, nasal symptoms, eye symptoms activity limitations and emotional function). Participants are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0=no impairment; 6=maximum impairment).~In this protocol, we used the nasal symptoms domain only; 4 questions, total scale ranges from 0 minimum to 24 maximum.~Longitudinal changes of nasal symptoms domain total were reported from baseline to 8 weeks."|8 weeks|Enrollment targets were not met for both arms/groups.|||units on a scale||Standard Deviation|Mean
1342039|NCT01921322|Secondary|Glycemic Variability|Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method|Up to 14 days in hospital|subjects incluced in final analysis|||mmol/L||Standard Deviation|Mean
1342040|NCT01921322|Primary|Time to Target|length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection|Up to 14 days in hospital|subjects included in final analysis|||days||Standard Deviation|Mean
1342041|NCT01921296|Other Pre-specified|Percentage of Patients That Experience Adverse Events|Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria|24 weeks||||percentage of participants|||Number
1342042|NCT01921296|Other Pre-specified|Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy|We will assess the number of patients who continue to take the original aromatase inhibitor medication at the 24 week timepoint, as assessed using patient self-report and medical records|24 weeks||||percentage of participants|||Number
1342043|NCT01921296|Secondary|Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment|||change in average pain||Full Range|Mean
1342094|NCT01920893|Secondary|Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16|The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90.|Baseline, Week 16|Participants from ITT population with SNOT-22 data available at Week 16.|||score on a scale||Standard Deviation|Mean
1342044|NCT01921296|Secondary|Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment|||change in T score||Full Range|Mean
1342045|NCT01921296|Primary|Number of Patients That Experience an Improvement in Sleep Quality as Assessed Using the Pittsburgh Sleep Quality Index (PSQI) With 8 Weeks of Cyclobenzaprine Therapy.|Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine. A total score is calculated for the Pittsburgh Sleep Quality Index. The total score ranges from 0-21, with higher scores representing worse sleep quality. Any reduction in PSQI total score was considered an improvement.|8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment|||participant|||Number
1342046|NCT01921270|Secondary|Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater|The UDRS measures dystonia severity. The UDRS is being rated by blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342047|NCT01921270|Secondary|Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater|"This scale measures the severity of dystonia for the jaw and tongue by an un-blinded rater. Dystonia is rated from 0 to 10:~0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia"|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342048|NCT01921270|Secondary|Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater|The UDRS measures dystonia severity. The UDRS is being rated by un-blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342049|NCT01921270|Secondary|Mean Global Clinical Impression- Efficacy Index Score|The Clinical Global Impression – Efficacy Index is a 4×4 rating scale that assesses the therapeutic effect of treatment. Responses range on a scale from 0 to 4 with 4 being the best response.|Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342050|NCT01921270|Secondary|Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score|"The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Responses are scored on a scale from 1 to 7; 1 represents normal, not at all ill and 7 represents among the most extremely ill patients."|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Error|Mean
1342051|NCT01921270|Secondary|Mean Global Clinical Impression - Improvement Scale (CGI) Index Score|"The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Responses are scored on a scale from 1 to 7; 1 represents very much improved and 7 represents very much worse."|Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342052|NCT01921270|Secondary|Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score|The OMDQ-25 is a subjective quality of life measurement made for patients with Oromandibular Dystonia. The maximum total score is 100 indicating the highest quality of life. A score of 50 indicates a mediocre quality of life. A lower score indicates perceived lower quality of life.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342265|NCT01918306|Secondary|Time to Progression - (Phase II)|Time to Progression (TTP) is calculated with the corresponding 95% confidence interval at the dose recommended for phase II. TTP is defined as the time from randomization until objective tumor progression, this does not include deaths unrelated to disease progression.|From time of randomization to disease progression, up to 104 weeks||||days to progression||Full Range|Median
1342053|NCT01921270|Secondary|"Mean Fahn-Marsden Part B Speech Question (BFM-q21) Rating"|"The Fahn-Marsden Part B Speech Question assesses the ease of producing speech. Responses range from 0=Normal, 1=Slightly involved, easily understood, 2=Some difficulty understanding, 3=Marked difficulty understanding."|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342054|NCT01921270|Secondary|Mean Swallowing Disturbance Questionnaire (SDQ-20) Score|Ease of chewing and swallowing will be assessed by the SDQ-20 (modified to exclude question 5 due to redundancy as it relates to drooling and question 15 which is not relevant to the study as it involves prior aspiration pneumonias). Individual items are scored from 0 (never) to 3 (very frequently). The overall score is the total for all items; a higher score indicating more frequent swallowing disturbance; a lower score indicating no or less frequent disturbance, with a possible maximum score of 39.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342055|NCT01921270|Secondary|Change in Number of Tongue Bites Per Day|The patient will be asked to estimate how many times they tend to accidentally/involuntarily bite their tongue per day.|Baseline, Week 12|Data were not collected.||||||
1342056|NCT01921270|Secondary|Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score|"The SCS-PD measures drooling. Individual items are scored on a scale from 0-3 where 0 represents never and 3 represents always. The overall maximum score is 21. A higher score indicates greater drooling severity. A lower score indicates lesser severity."|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342057|NCT01921270|Secondary|Change in Analogue Pain Scale Score|"Measure of jaw pain by visual analogue scale (0-100) where 0 represents no pain and 100 represents the most severe pain."|Baseline, Week 12|Data were not collected.||||||
1342058|NCT01921270|Primary|Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater|"This scale measures the severity of dystonia for the jaw and tongue by a blinded rater. Dystonia is rated from 0 to 10:~0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia"|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
1342059|NCT01921257|Primary|Number of Subjects With AEs|To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.|up to 36 weeks after start of treatment|All subjects enrolled|||participants|||Number
1342060|NCT01921205|Secondary|Proportion of Subjects Who Achieved “Seizure Free” Status (Yes/no) for Subjects Who Completed the Maintenance Period|The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.|Week 7 to Week 16|Percentages are based on the number of subjects in the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects who completed the Maintenance Period have been included in this analysis.|||percentage of participants|||Number
1342061|NCT01921205|Secondary|Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period|The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.|Week 7 to Week 16|Percentages are based on the number of subjects in the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects who completed the Maintenance Period have been included in this analysis.|||days||Standard Deviation|Mean
1342062|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Secondary Generalized Seizures were included in this analysis.|||Seizures per 28 days||Full Range|Median
1342063|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Complex Partial Seizures were included in this analysis.|||Seizures per 28 days||Full Range|Median
1342064|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Simple Partial Seizures were included in this analysis.|||Seizures per 28 days||Full Range|Median
1342065|NCT01921205|Secondary|Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|Proportion of subjects is presented as percentage of participants. An increase is defined as a >=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise <25% increase is defined as no increase.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.|||percentage of participants|||Number
1342066|NCT01921205|Secondary|Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|Proportion of subjects is presented as percentage of participants. No change is defined as between <25% reduction and <25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between <25% reduction and <25% increase is defined as a change.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.|||percentage of participants|||Number
1342067|NCT01921205|Secondary|Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Treatment Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A >=50%-<=75% response in the Treatment Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data.|||percentage of participants|||Number
1342068|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis.|||Seizures per 28 days||Full Range|Median
1342069|NCT01921205|Secondary|Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period|Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Maintenance Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A >=50%-<=75% response in the Maintenance Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data.|||percentage of participants|||Number
1342070|NCT01921205|Secondary|Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.|||percentage of participants|||Number
1342071|NCT01921205|Primary|Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis.|||Seizures per 28 days||Full Range|Median
1342072|NCT01921166|Other Pre-specified|Number of Embryos From Vitrified Oocytes|per ovarian stimulation treatment protocol|up to 24 months|||||||
1342073|NCT01921166|Secondary|Number of Oocytes Vitrified||up to 24 months||||oocytes|||Number
1342074|NCT01921166|Primary|Oocytes|Number of oocytes retrieved|up to 24 months||||oocytes|oocytes||Number
1342075|NCT01921101|Other Pre-specified|Immune Parameters|Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14|baseline and weekly while hospitalized|||||||
1342076|NCT01921101|Secondary|Death|The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge|date of occurence||||participants|||Number
1342077|NCT01921101|Secondary|Days on Mechanical Ventilation|the total number of days requiring mechanical ventilation while hospitalized|days|||||||
1342078|NCT01921101|Secondary|Length of Hospital Stay|The total number of days the patient is in the hospital|days in hospital|||||||
1342079|NCT01921101|Primary|Infection|All new infections that occurred (including blood, wound, sputum, urinary tract and pulmonary) from enrollment through hospital discharge recorded in the medical record were counted|Assessed daily from study enrollment through hospital discharge, an average of 3 weeks||||participants|||Number
1342080|NCT01920958|Secondary|Percentage of Participants With Post-Operative Complications and Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
1342081|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
1342082|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced|Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
1342083|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
1342084|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
1342085|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time|Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.|Peri- and post-surgery (Up to 50 Days)|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
1342086|NCT01920958|Secondary|Length of Hospital and ICU Stay|Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.|Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||days||Standard Deviation|Mean
1342087|NCT01920958|Secondary|Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume||Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||percentage of participants|||Number
1342088|NCT01920958|Secondary|Percentage of Participants With at Least One Drainage Inserted|The total number of participants where at least one drainage was used during the operation.|Baseline (Day of Surgery)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||percentage of participants|||Number
1342089|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale|The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||score on a scale||Standard Deviation|Mean
1342090|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale|The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||score on a scale||Standard Deviation|Mean
1342091|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale|The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||score on a scale||Standard Deviation|Mean
1342092|NCT01920958|Primary|Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge||Up to 50 Days|Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery.|||percentage of participants|||Number
1342093|NCT01920893|Post-Hoc|Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16|nTSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale. Total score ranges from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated severe symptoms.|Baseline, Week 16|Participants from ITT population with nTSS data available at Week 16.|||score on a scale||Standard Deviation|Mean
1342902|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
1342095|NCT01920893|Secondary|Time to First Response in NPS: Kaplan-Meier Estimate at Week 16|The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as >=1 point reduction from baseline score); for participants without NPS >=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics.|Baseline to Week 16|ITT population.|||Probability of response||95% Confidence Interval|Number
1342096|NCT01920893|Secondary|Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease|CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease.|Baseline, Week 16|Participants from ITT population with CT scan data available at Week 16.|||percent area||Standard Deviation|Mean
1342097|NCT01920893|Secondary|Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score|CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status.|Baseline, Week 16|Participants from ITT population with CT scan data available at Week 16.|||score on scale||Standard Deviation|Mean
1342098|NCT01920893|Secondary|Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16|UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss.|Baseline, Week 16|Participants from ITT population with data available for UPSIT at Week 16.|||score on scale||Standard Deviation|Mean
1342099|NCT01920893|Secondary|Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16|NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute.|Baseline, Week 16|Participants from ITT population with data available for NPIF at Week 16.|||liter/minute||Standard Deviation|Mean
1342100|NCT01920893|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16|Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.|Baseline, Week 16|Participants from ITT population with data available for Rhinosinusitis Symptoms Severity VAS at Week 16.|||centimetre (cm)||Standard Deviation|Mean
1342101|NCT01920893|Secondary|Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16|Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms.|Baseline, Week 16|Participants from ITT population with data available for symptom score at Week 16.|||score on a scale||Standard Deviation|Mean
1342102|NCT01920893|Secondary|Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma|NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.|Baseline, Week 16|Participants of the ITT population with asthma and with available data at Week 16.|||score on a scale||Standard Deviation|Mean
1342103|NCT01920893|Primary|Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16|NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.|Baseline, Week 16|Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization. Here, number analyzed = number of participants with available data for specified time points.|||score on a scale||Standard Deviation|Mean
1342104|NCT01920854|Primary|Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6|The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)|Baseline (1 day)|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||mg/dL||Standard Deviation|Mean
1342105|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)|"Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||dL||Standard Deviation|Mean
1342106|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)|"Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||hours||Standard Deviation|Mean
1342284|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)||||steps per day||Standard Deviation|Mean
1342107|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)|"Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||1/hour||Standard Deviation|Mean
1342108|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)|"Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL/mg||Standard Deviation|Mean
1342109|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)|"Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||hours||Full Range|Median
1342110|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)|"Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||microgram/dL||Standard Deviation|Mean
1342111|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])|"Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||dL/hour||Standard Deviation|Mean
1342112|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)|"Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||h*microgram/dL||Standard Deviation|Mean
1342113|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)|"Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||h*microgram/dL||Standard Deviation|Mean
1342114|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342115|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342116|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342117|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342118|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342119|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342120|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||percentage of saturation||Standard Deviation|Mean
1342134|NCT01920594|Secondary|PK Parameters in CSF: Tmax of GSK1278863|CSF samples were collected immediately after the lumbar drain was placed, just prior to PNI, and 2, 24, 36 and 48 hours post PNI. In participants that developed spinal ischemia, the CSF drain was potentially maintained for longer than 48 hours. In that instance, daily CSF samples for PK were collected until the drain was removed. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours||95% Confidence Interval|Mean
1342121|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||percentage of saturation||Standard Deviation|Mean
1342122|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342123|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342124|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342125|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
1342126|NCT01920802|Other Pre-specified|Change in Lipid Metabolism|Change in lipid metabolism as measured by cholesterol/HDL ratio|Baseline to Day 28||||ratio||Standard Deviation|Mean
1342127|NCT01920802|Other Pre-specified|Change in Food Intake|Total grams of food consumed|Baseline to Day 28||||grams||Standard Deviation|Mean
1342128|NCT01920802|Other Pre-specified|Insulin Resistance|Homeostatic model assessment for Insulin Resistance (HOMA-IR) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin.|Baseline to Day 28||||HOMA-IR score||Standard Deviation|Mean
1342129|NCT01920802|Other Pre-specified|Change in Insulin|Change in Insulin levels from baseline to Day 28|Baseline to Day 28||||mlU/L||Standard Deviation|Mean
1342130|NCT01920802|Other Pre-specified|Change Glucose in People Taking Olanzapine or Iloperidone|To quantify, prospectively, change in glucose from baseline to Day 28|Baseline to study termination (about 12 weeks)||||mg/dL||Standard Deviation|Mean
1342131|NCT01920802|Secondary|Change in Leptin|Leptin levels measured at Day 3 compared to baseline|change in baseline to Day 3||||ng/dL||Standard Deviation|Mean
1342132|NCT01920802|Primary|Change in Adiposity|Total fat mass (excluding head) from baseline to Day 28|Baseline to Day 28||||grams||Standard Deviation|Mean
1342133|NCT01920802|Primary|Change in Body Weight|Delineate a pathophysiological mechanism of antipsychotic induced weight gain|baseline and 6 week visit||||kg||Standard Deviation|Mean
1342300|NCT01917526|Primary|Number of Participants With Hypoxemia in Both Groups|Hypoxemia is defined as oxygen saturation < 94%. We record number of participants with hypoxemia in both groups|In PACU (1 hr after anesthesia)||||number of participants|||Number
1353416|NCT01753557|Secondary|Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)||24 weeks||||percentage of subjects achieving ETR||95% Confidence Interval|Number
1342135|NCT01920594|Secondary|PK Parameters in Blood: Time of Occurrence of Cmax (Tmax) of GSK1278863|Blood samples for PK analysis AUC(0-t) were collected at pre-dose (prior to the 100 mg dose), 1-3 hours after study drug was administered and then every 5 hours for 24 hours. On Days 1 and 3 samples were collected at pre-dose then 1, 3, 8 and 24 hours post dose. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
1342136|NCT01920594|Secondary|PK Parameters in CSF: Cmax of GSK1278863|CSF samples were collected immediately after the lumbar drain was placed, just prior to PNI, and 2, 24, 36 and 48 hours post PNI. In participants that developed spinal ischemia, the CSF drain was potentially maintained for longer than 48 hours. In that instance, daily CSF samples for PK were collected until the drain was removed. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI|PK Population. Only those participants available at the indicated time points were analyzed.|||Ng/L||Geometric Coefficient of Variation|Geometric Mean
1342137|NCT01920594|Secondary|PK Parameters in Blood: Maximum Observed Concentration (Cmax) of GSK1278863|Blood samples for PK analysis AUC(0-t) were collected at pre-dose (prior to the 100 mg dose), 1-3 hours after study drug was administered and then every 5 hours for 24 hours. On Days 1 and 3 samples were collected at pre-dose then 1, 3, 8 and 24 hours post dose. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3|PK population. Only those participants available at the indicated time points were analyzed.|||Ng/mL||Geometric Coefficient of Variation|Geometric Mean
1342138|NCT01920594|Secondary|PK Parameters in CSF: AUC(0-t) of GSK1278863|CSF samples were collected immediately after the lumbar drain was placed, just prior to PNI, and 2, 24, 36 and 48 hours post PNI. In participants that developed spinal ischemia, the CSF drain was potentially maintained for longer than 48 hours. In that instance, daily CSF samples for PK were collected until the drain was removed. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1342139|NCT01920594|Secondary|Pharmacokinetic (PK) Parameters in Blood: AUC(0-t) of GSK1278863|Blood samples for PK analysis AUC(0-t) were collected at pre-dose (prior to the 100 mg dose), 1-3 hours after study drug was administered and then every 5 hours for 24 hours. On Days 1 and 3 samples were collected at pre-dose then 1, 3, 8 and 24 hours post dose. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1342140|NCT01920594|Secondary|Number of Participants With Composite Index of All Cause Mortality and Disability (NIHSS>5/ASIA<40)|The NIHSS was a systematic assessment tool that provided a quantitative measure of stroke-related neurologic deficit. Ratings for each item are scored with 0 as normal, and there was an allowance for untestable items. The NIHSS scores were categorized as: No event (NIHSS score=0), Mild (NIHSS score 1–4), Moderate (NIHSS score 5-15), or Severe (NIHSS score >15). The ASIA score was developed by the American Spinal Injury Association for the neurologic assessment of participants with a spinal injury. In this study, only the ASIA lower extremity motor score was assessed. This comprised five muscle groups scored from 0-5 on both the left and right lower extremities, for a maximal total score of 50. The ASIA scores were categorized as: mild (ASIA score 41-50), moderate (ASIA score 26-40), or severe (ASIA score <=25). “Composite above” includes participants with NIHSS>5 or ASIA<40 at the 30-day Follow-up or Death.|Up to Follow-up (Day 45)|PD Population.|||Participants|||Count of Participants
1342141|NCT01920594|Secondary|Assessment in AUC for Markers of Ischemic Organ Injury Including Tropinin Within 48 Hours|AUC from 8 hours post surgery (up to 48 hours post surgery) was derived for markers of ischemic organ injury troponin I and troponin T. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Baseline (Day 0) and 8 to 48 hours following DTA/TAAA repair|PD population. Only those participants available at the indicated time points were analyzed.|||µg*hour/L||Geometric Coefficient of Variation|Geometric Mean
1342142|NCT01920594|Secondary|Number of Participants With Clinical Composite of All Cause Mortality, Stroke, Spinal Infarction, MI, Need for Dialysis/Sustained Doubling of Serum Creatinine|The clinical composite event rate included all-cause mortality (death), stroke, spinal infarction (paraplegia which was due to spinal infarct a result of the surgery, myocardial infarction, and the need for dialysis or sustained doubling of serum creatinine (acute kidney injury). The clinical composite endpoint used a first occurrence approach, i.e. a composite event was recorded at the time of first occurrence of any component of the composite.|Up to Follow-up (Day 45)|All Subjects Population.|||Participants|||Count of Participants
1342143|NCT01920594|Secondary|Number of Participants With Neurologic Outcomes Assessed by the American Spinal Injury Association (ASIA) Lower Extremity Motor Outcome Scale|The ASIA score was developed by the American Spinal Injury Association for the neurologic assessment of participants with a spinal injury. In this study, only the ASIA lower extremity motor score was assessed. This comprised five muscle groups scored from 0-5 on both the left and right lower extremities, for a maximal total score of 50. The ASIA scores were categorized as: mild (ASIA score 41-50), moderate (ASIA score 26-40), or severe (ASIA score <=25).|Surgical Day (Day 0), Post-operative Day 1, 2, 7 and follow-up (Day 45)|PD population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1342301|NCT01917513|Secondary|Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.|The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm|Up to 14 days (histology results)|||||||
1342144|NCT01920594|Secondary|Number of Participants With Neurologic Outcomes Assessed by Modified Rankin Scale (mRS)|The mRS was a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS was a 6 point disability scale with possible scores ranging from 0 up to 5. A separate category (of 6) was added for participants who died. The mRS scores were categorized as mild (mRS score 0-1), moderate (mRS score 2-3), or severe (mRS score >=4).|Post-operative Day 7 and follow-up (Day 45)|PD population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1342145|NCT01920594|Secondary|Number of Participants With Neurologic Outcomes Assessed by the National Institutes of Health Stroke Scale (NIHSS)|The NIHSS was a systematic assessment tool that provided a quantitative measure of stroke-related neurologic deficit. A trained observer rates the participant’s ability to answer questions and perform activities. Ratings for each item are scored with 0 as normal, and there was an allowance for untestable items. The NIHSS scores were categorized as: No event (NIHSS score=0), Mild (NIHSS score 1–4), Moderate (NIHSS score 5-15), or Severe (NIHSS score >15). The single participant assessment required less than 10 minutes to complete. Data for participants with NIHSS administrated at surgical day, post-operative Day 1, Day 2, Day 7 and Follow-up Visit has been reported.|Surgical Day (Day 0), Post-operative Day 1, 2, 7 and follow-up (Day 45)|PD population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1342146|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Neuron-specific Enolase (NSE) Within 48 Hours Following DTA/TAAA Repair|CSF biomarker NSE samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF NSE. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD Population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||µg/L||Standard Deviation|Mean
1342147|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Tau Protein Within 48 Hours Following DTA/TAAA Repair|CSF biomarker tau protein samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF tau protein. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD Population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||ng/L||Standard Deviation|Mean
1342148|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Lactate Dehydrogenase Within 48 Hours Following DTA/TAAA Repair|CSF biomarker lactate dehydrogenase samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF lactate dehydrogenase. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD Population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1342149|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Erythropoietin Within 48 Hours Following DTA/TAAA Repair|CSF biomarker erythropoietin samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF erythropoietin. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||International units per liter (IU/L)||Standard Deviation|Mean
1342150|NCT01920594|Secondary|Change From Baseline in AUC for CSF GFAP to 48 Hours|GFAP was a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. AUC for CSF GFAP from Baseline to 48 hours following DTA/TAAA repair was assessed to measure central nervous system injury. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline(Day 0) to 48 hours following DTA/TAAA repair|PD Population.|||Hour*microgram per liter (hour*µg/L)||Geometric Coefficient of Variation|Geometric Mean
1342151|NCT01920594|Secondary|Change From Baseline in Area Under Curve (AUC) for CSF S100 Beta to 48 Hours|S100 beta was a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. AUC for CSF S100 beta from Baseline to 48 hours following DTA/TAAA repair was assessed to measure central nervous system injury. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline(Day 0) to 48 hours following DTA/TAAA repair|PD Population.|||Hour*nanogram per liter (hour*ng/L)||Geometric Coefficient of Variation|Geometric Mean
1342152|NCT01920594|Secondary|Number of Participants With Hematology Parameters of PCI|Blood samples for assessment of hematology parameters platelet count, red blood cell count, white blood cell count, reticulocyte count, hemoglobin, hematocrit, mean corpuscle volume, mean corpuscle hemoglobin, mean corpuscle hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils and basophils was done at Randomization, Day 0 (done prior to 100 mg on-call dosing), 1, 2, 3, 4, 5, 6 and 7. Only those parameters for which at least one value of PCI was reported are summarized. Data for participants with hematology values outside the PCI range has been presented.|Up to post-operative Day 7|All Subjects Population.|||Participants|||Count of Participants
1342302|NCT01917513|Primary|Detection Rate of Adenomas and Serrated Lesions|The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group|Approximalty following 14 days (histology results)||||Participants|||Count of Participants
1342303|NCT01917344|Secondary|Tremor as Determined Through Neurological Evaluation||During period of evaluation, approximately 8 hours|||||||
1342153|NCT01920594|Secondary|Number of Participants With Clinical Chemistry Parameters of PCI|Blood samples for assessment of clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, blood urea nitrogen (BUN), creatinine, glucose, sodium, creatine phosphokinase, potassium, chloride, total carbon dioxide, calcium, total and direct bilirubin, uric acid, albumin and total protein was done at Randomization, Day 0 (done prior to 100 mg on-call dosing), 1, 2, 3, 4, 5, 6 and 7. Only those parameters for which at least one value of PCI was reported are summarized. Data for participants with clinical chemistry values outside the PCI range has been presented.|Up to post-operative Day 7|All Subjects Population.|||Participants|||Count of Participants
1342154|NCT01920594|Secondary|Number of Participants With Abnormal Electrocardiography (ECG) Parameters|Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate intervals. Data for participants with abnormal-clinical significant (CS) and abnormal-not clinically significant (NCS) ECG findings on post-operative Days 1, 2, 3, 4, 5, 6, 7 and during Follow-up Visits has been presented.|Up to Follow-up (Day 45)|All Subjects Population.|||Participants|||Count of Participants
1342155|NCT01920594|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI)|Vital sign measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate. Criteria for vital sign values meeting PCI included: SBP < 70 millimeters of mercury (mmHg) and > 160 mmHg; DBP < 45 mmHg and > 110 mmHg. Data for participants with vital signs values outside the potential clinical importance range has been presented. Only those parameters for which at least one value of PCI was reported are summarized.|Up to Follow-up (Day 45)|All Subjects Population.|||Participants|||Count of Participants
1342156|NCT01920594|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, considered to be medically significant or is associated with liver injury and impaired liver function.|Up to Follow-up (Day 45)|All Subjects Population comprised of all participants who received at least one dose of study drug (GSK1278863 or placebo).|||Participants|||Count of Participants
1342157|NCT01920594|Primary|Change From Baseline to Peak in CSF Glial Fibrillary Acidic Protein (GFAP) Within 48 Hours Following DTA/TAAA Repair|GFAP is a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. CSF samples for the analysis of GFAP was collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF GFAP. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||Microgram per liter (µg/L)||Standard Deviation|Mean
1342158|NCT01920594|Primary|Change From Baseline to Peak in Cerebrospinal Fluid (CSF) S100 Beta Within 48 Hours Following Descending Thoracic Aorta/Thoracoabdominal Aortic Aneurysm (DTA/TAAA) Repair|S100 beta is a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF S100 beta. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|Pharmacodynamic (PD) population comprised of all participants from whom PD data was available. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||Nanograms per liter (ng/L)||Standard Deviation|Mean
1342159|NCT01920568|Secondary|Serum Concentration of Denosumab on Day 1, at Week 2, Week 5, Week 9, Week 13, Week 17, Week 19, Week 21, Week 25 and Week 49|Blood samples were drawn on study Day 1, pre-dose; 4 hours, 24 hours, and at Week 2 (168 hours); then pre-dose at Week 5, Week 9, Week 13, Week 17, Week 19 (no dose), Week 21, Week 25, and Week 49.|Samples were collected at pre-dose (Day 1); 4 hours, 24 hours, 168 hours post-dose; pre-dose at Week 5, Week 9, Week 13, Week 17; Week 19 (at 336 hours); pre-dose at Week 21, Week 25, Week 49|Pharmacokinetic (PK) Population: comprised of participants who signed informed consent to participate in the PK sub-study and who had their PK parameters evaluable according to GSK standards. Only those participants with evaluable parameters are included (represented by n=X in the category titles).|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1342160|NCT01920568|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Day 1, Week 25 and Week 53.|Anti-denosumab antibody formation was assessed at Day 1, Week 25 and Week 53. Binding antibody assay was used to assess number of participants with anti-denosumab antibody.|Day 1, Week 25 and Week 53|FAS-Safety Population. Only those participants on whom anti-denosumab antibody formation was analyzed at specified time point is presented (represented by n=X, X in the category titles).|||Participants|||Number
1342161|NCT01920568|Secondary|Number of Participants With Worst-case On-therapy Increase in the Indicated Hematology Parameters From Baseline Grade to the Indicated Grade.|Hematology parameters included hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell (WBC) count. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy lab values were available (represented by n=X, X in the category titles) were analyzed.|||Participants|||Number
1342304|NCT01917344|Secondary|Diffusion Tensor Imaging (DTI) Findings Through MRI||During period of evaluation, approximately 8 hours|||||||
1342305|NCT01917344|Secondary|Volumetric MRI Findings||During period of evaluation, approximately 8 hours|||||||
1342162|NCT01920568|Secondary|Number of Participants With Worst-case (WC) On-therapy Increase in the Indicated Clinical Chemistry Parameters From Baseline Grade to the Indicated Grade.|Clinical chemistry parameters were measured at the Screening and Weeks 2, 5, 9, 13, 25, 37, and 53 visits. Clinical chemistry parameters measured on-study included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium (Ca), creatinine, magnesium, and phosphorous (P) inorganic. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) was used for grading. Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy laboratory values were available (represented by n=X, X in the category title) were analyzed.|||Participants|||Number
1342163|NCT01920568|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, non-fatal SAEs, fatal SAEs have been presented.|From start of IP through the Study Phase (49 weeks post-dose) (assessed up to 73 weeks)|Full-Analysis-Set Safety (FAS-Safety) Population: comprised of all randomized participants who received at least one dose of study treatment and was based on the actual study treatment received (if this differed from that to which the participant was randomized).|||Participants|||Number
1342164|NCT01920568|Secondary|Percent Change From Baseline in the Serum Bone-specific Alkaline Phosphatase (s-BALP) at Week 13.|Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Indicated visit minus Baseline value. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100.|Baseline and Week 13|FAS-ITT Population. All participants who were randomized and had a observed values at Baseline and Week 13 were used in the analysis.|||Percent change||Full Range|Median
1342165|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Participants With Advanced Breast Cancer.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in breast cancer par. with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Participants with advanced breast cancer.|||Percent change||95% Confidence Interval|Least Squares Mean
1342166|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Chinese Participants.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Chinese ancestry with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Chinese participants.|||Percent change||95% Confidence Interval|Least Squares Mean
1342167|NCT01920568|Primary|Percent Change (Chg) From Baseline (BL) to Week (Wk)13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr)|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment (trt). uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Primary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Asian ancestry with bone metastases from solid tumors. BL value is the most recent, non-missing value prior to or on the 1st study trt dose date. Chg from BL is the value at Wk13 minus BL value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline (BL) and Week (Wk) 13|Full-Analysis-Set Intent-to-Treat (FAS-ITT) Population: comprised of all randomized participants regardless of whether or not study treatment was administered. Only those participants with values at Baseline and Week 13 were included in the analysis.|||Percent change||95% Confidence Interval|Least Squares Mean
1342168|NCT01920555|Secondary|Number of Participants With Abnormal and Clinically Significant CBC and Chemistry Labs by Treatment|"CBC~Chemistry (Total bilirubin, AST, ALT, GGT, ALK Phosphatase, Creatinine, BUN/Urea, Glucose, Uric Acid)~Testing was performed by study site laboratories and used institutional normal lab value ranges."|Day 3 and Early Termination Visit (approximately 3 weeks following intervention)||||Participants|||Count of Participants
1342306|NCT01917344|Secondary|Electroencephalogram (EEG) Findings||During period of evaluation, approximately 8 hours|||||||
1342307|NCT01917344|Secondary|Full Scale Intelligence Quotient (IQ)||During period of evaluation, approximately 8 hours|||||||
1353417|NCT01753557|Secondary|Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)||4 weeks||||percentage of subjects achieving RVR||95% Confidence Interval|Number
1342169|NCT01920555|Secondary|Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)|The Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed in the National Institute of Mental Health Treatment of Adolescent Suicide Attempters Study to assess severity and track suicidal events through any treatment. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening or improvement. It contains 5 rating scale questions (yes/no) for suicidal ideation increasing severity and 5 rating scale questions (yes/no) for suicidal behavior of increasing severity. The time frame is for both lifetime and the past six months for the Baseline/Screening scale and since the last visit for the Since Last Visit scale.|Screening Visit and Days 0, 1, 3, 5, 7, 14 and 30 combined||||Participants|||Count of Participants
1342170|NCT01920555|Secondary|Clinician-Administered Dissociative States Scale (CADSS) Scores During Infusion|The CADSS is a 23-item self-report scale for the assessment of dissociative states. It is a reliable, valid self-report instrument. The severity of each dissociative symptom ranges from 0 (not present) to 4 (extreme). The total score is calculated by summing across items, with a total possible range of 0-92. The CADSS was administered right before infusion, and 40, 80 minute and 120 minutes after the start of infusion. The timeframe is “at this moment”.|Day 0/baseline at 0, 40, 80, and 120 minutes||||units on a scale||Standard Deviation|Mean
1342171|NCT01920555|Secondary|Snaith-Hamilton Pleasure-Scale (SHAPS)|"The SHAPS is a 14-item self-report scale to measure hedonic tone. Items (e.g., I would enjoy reading a book, magazine, or newspaper.) are rated on a 4-point scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Either of the ‘disagree’ responses scores 1 point, and either of the ‘agree’ responses scores 0 points, for a total scale range of 0-14. Higher scores indicate greater inability to experience pleasure. Patients were asked to rate their experience of the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
1342172|NCT01920555|Secondary|Clinical Positive Affect Scale (CPAS)|"The CPAS is a 16-item self-report scale to assess the level to which participants experience persistent distress due to feeling that they have not returned to their normal or premorbid state. Items (e.g., I look forward to things) are rated on a 5-point scale (0=not at all, 1=very much less than normal, 2=much less than normal, 3=slightly less than normal, 4=same as best or normal self). The possible scale range is 0 to 64, with higher scores indicating greater recovery from depression. Patients were asked to rate their experience of the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
1342173|NCT01920555|Secondary|Symptoms of Depression Questionnaire (SDQ)|"The SDQ is a 44-item self-report scale, which aims to measure depression more comprehensively by including the assessment of symptoms in the anxiety–depression spectrum, including symptoms of irritability, anger attacks, and anxiety. Items are rated on an 6-point Likert scale, where participants are asked to rate if a specific symptom (e.g. How has your mood been over the past 24 hours?) is normal for him or her (score = 2), what is better than normal (score = 1), and what is worse than normal (scores = 3–6). The total scale score is calculated by averaging across the items, resulting in a possible range from 1 to 6. Higher scores indicate greater depression severity. When rating, patients were asked to consider their symptoms during the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
1342174|NCT01920555|Secondary|Clinical Global Impressions–Improvement (CGI-I) Scale|"The CGI-I is a clinician rated single-item scale: Compared to the patient’s condition at admission, how much has the patient changed?, rated on a 7-point response scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse. In this case, admission referred to the CGI-S screening assessments performed between Day -28 an -7, one conducted during the screening visit, and a second rating conducted by a remote, independent rater."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
1342175|NCT01920555|Secondary|Clinical Global Impressions–Severity (CGI-S)|"The CGI-S is a clinician rated single-item scale: How depressed is the patient at this time?, rated on a 7-point response scale: 1 = Normal, not at all depressed, 2 = Borderline depressed, 3 = Mildly depressed, 4 = Moderately depressed. 5 = Markedly depressed, 6 = severely depressed, 7 = Among the most severely depressed patients. When rating patients, clinicians were asked to consider the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
1342198|NCT01919723|Secondary|Bleeding Complications|Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.|up to 24 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||Number of subjects|||Number
1342176|NCT01920555|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|"The MADRS is a 10-item clinician-rated scale measuring depression severity. Symptoms are rated on a 7-point scale, where 0 = not present, and 1-6 represent increasing severity. Values 2, 4, and 6 have specific anchoring text (e.g., 2=Difficulties in starting activities. 4=Difficulties in starting simple routine activities which are carried out with effort, 6=Complete lassitude. Unable to do anything without help.) Values 1, 3, and 5 do not have specific text. The possible scale range is 0-60, where higher values represent higher severity. In this study, the MADRS was used to rate symptoms occurring in the past 3 days."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0 and 3.|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
1342177|NCT01920555|Primary|Hamilton Rating Scale for Depression - 6 Items|The HAMD6 is a 6-item clinician-rated scale, where clinicians rate the presence of depression symptoms (i.e., depressed mood, guilt, work and interests, psychomotor retardation, psychic anxiety, somatic symptoms) on a 5-point scale, where 0 = not present, and 1-4 represent increasingly severe symptoms. One item (i.e., somatic symptoms) is rated on only a 3-point scale, ranging from 0-2. The possible scale range is 0-22, where higher values represent more severe depression. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. In this study, the HAMD6 was used to assess symptoms occurring in the past 24 hours.|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1, & 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
1342178|NCT01920282|Other Pre-specified|Oxidized LDL Concentration||12 weeks|||||||
1342179|NCT01920282|Secondary|Insulin Sensitivity (HOMA-IR)|The HOMA index was calculated as the product of plasma blood glucose and insulin divided by 22.5.|12 weeks||||Arbitrary units||Standard Error|Mean
1342180|NCT01920282|Primary|Beta-stiffness Index|Longitudinal B-mode images of the left common carotid artery diameter (1-2 cm proximal to the carotid bulb) were obtained over 15 consecutive cardiac cycles. Brachial blood pressure was measured via an automated sphygmomanometer. Quantification of systolic and diastolic carotid artery diameters were analyzed with the Vascular Research Tools 5 software program. Beta-stiffness index was calculated as: Beta = ln(P1/P0)/((D1-D0)/D0), where D0 represents the minimal diameter recorded during diastole, D1 represents the maximal diameter recorded during systole, P0 represents the pressure measured during diastole, and P1 represents the pressure measured during systole.|12 weeks||||Arbitrary units||Standard Error|Mean
1342181|NCT01920178|Other Pre-specified|Number of Participants With Adverse Events During and Following Each Study Treatment||12 months||||participants|||Number
1342182|NCT01920178|Secondary|Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples||12 months|PCR lab analysis of nail samples obtained for each subject was not performed with the original study sponsor Nuvolase, Inc/ PinPointe withdrawing support for such analysis during the study.||||||
1342183|NCT01920178|Primary|Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator.||12 months|Original grooved markings scored into the Target nails (hallux nails) on initial laser treatment visit to indicate most proximal aspect of fungal infection was intended to track the growth of the nail and to evaluate for improvement. Grooved markings did not survive after initial visit making it impossible to obtain valid primary endpoint data.||||||
1342184|NCT01919996|Secondary|Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations|Clinically significant change (improvement or worsening) is based on five ophthalmic exams at baseline and the final visit. Any 1 or more of these conditions are a clinically significant change: 1) A worsening in BCVA (distance), as defined in outcome measure 1 OR an improvement in BCVA (distance) as defined in outcome measure 2. 2) A worsening in color vision (FM-100), as defined in outcome measure 1 OR an improvement in color vision (FM-100) as defined in outcome measure 2. 3) A worsening in Amsler Grid, as defined in outcome measure 1, OR an improvement in Amsler Grid, as defined in outcome measure 2. 4) A worsening in anterior segment biomicroscopy, as defined in outcome measure 1 OR an improvement in anterior segment biomicroscopy as defined in outcome measure 2. 5) A worsening in dilated indirect ophthalmoscopy, as defined in outcome measure 1 OR an improvement in dilated indirect ophthalmoscopy as defined in outcome measure 2.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).|||percentage of participants|||Number
1342185|NCT01919996|Secondary|Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations|1 or more of these conditions are clinically significant improvement based on five ophthalmic exams:1) clinically significant improvement in BCVA(distance) at the final visit, in either eye, defined as an increase in score of 5 or more letters from baseline in ETDRS BCVA.2) Assessment of abnormal clinically significant at baseline and normal or abnormal, non-clinically significant at final visit in color vision(FM-100) in either eye. 3) Assessment of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5)Assessments of abnormal clinically significant at baseline and normal/abnormal, nonclinically significant at final visit in dilated ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).|||percentage of participants|||Number
1342199|NCT01919723|Secondary|High On-treatment Platelet Reactivity (HPR)|Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.|Comparing baseline and follow-up (2 hours)|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||percentage of participants|||Number
1342186|NCT01919996|Primary|Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations|Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).|||percentage of participants|||Number
1342187|NCT01919801|Other Pre-specified|Area Under the Plasma Concentration Versus Time Curve (AUC) of Icatibant and Its Metabolites (M1 and M2)|Area under the plasma concentration-time curve of Icatibant and its metabolites (M1 and M2) were analyzed. A population pharmacokinetic analysis approach using sparse pharmacokinetic sampling obtained from a subset of subjects was used to evaluate exposure to icatibant.|0.75 and 2 hours post-dose|PK analysis population.|||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
1342188|NCT01919801|Secondary|Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|4, 6, and 8 hours post treatment|mITT population.|||percentage of participants|||Number
1342189|NCT01919801|Secondary|Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration|Number of participants with the use of conventional medications (corticosteroids, antihistamines, epinephrine) for the treatment of symptoms of the ACE-I- induced angioedema attack following study drug administration were presented.|Day 0 up to Day 5|mITT population.|||participants|||Number
1342190|NCT01919801|Secondary|Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)|Number of participants with and without an occurrence of admission to the hospital (inpatient) or ICU post-treatment due to the ACE-I-induced angioedema attack were described.|Day 0 up to Day 5|mITT population.|||participants|||Number
1342191|NCT01919801|Secondary|Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema|Airway Intervention included intubation, tracheotomy, cricothyrotomy.|Day 0 up to Day 5|Modified Intent to treat (mITT) population included all randomized participants who received the study drug.|||participants|||Number
1342192|NCT01919801|Secondary|Time to Onset of Symptom Relief (TOSR)|TOSR was calculated for the individual symptoms with pre-treatment scores of 2 (moderate) or more improved by at least 1 severity grade and the individual symptoms with pretreatment scores of 0 or 1 (absent or mild) were scored again at 0 or 1 and all the subsequent assessments continued to satisfy this condition. Time-to-event data were summarized using Kaplan-Meier estimates.|Day 0 up to Day 5|ITT population.|||days||Inter-Quartile Range|Median
1342193|NCT01919801|Primary|Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination|During laboratory evaluation, serum chemistry and hematology blood tests, and urinalysis were performed. Vital signs parameters included evaluation of pulse rate and systolic and diastolic blood pressure. Standard 12-lead ECGs were performed and ECG recordings were read locally at the study site by a cardiologist. Physical examination was performed with examination of major body systems per routine clinical practice.|Day 0 to Day 5|Safety population.|||participants|||Number
1342194|NCT01919801|Primary|Number of Participants With Treatment Emergent Injection Site Reaction|Injection site reaction included erythema, swelling, cutaneous pain, burning sensation, itching and warm sensation|Day 0 to Day 5|Safety population.|||participants|||Number
1342195|NCT01919801|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study drug administration (Day 0) up to follow-up (Day 5)|Safety population included all participants who received the study drug.|||participants|||Number
1342196|NCT01919801|Primary|Time to Meeting Discharge Criteria (TMDC)|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|Day 0 up to Day 5|Intent-to-treat (ITT) population included all randomized participants.|||days||Inter-Quartile Range|Median
1342197|NCT01919723|Secondary|Periprocedural Myocardial Infarction (PMI)|Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values >5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values >20% after PCI if the baseline value was elevated.|Up to 24 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||Number of subjects|||Number
1342200|NCT01919723|Primary|Change in Percent Inhibition of Platelet Aggregation (%IPA)|Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.|Baseline and 2 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||percentage of IPA||Standard Deviation|Mean
1342201|NCT01919606|Secondary|Incidence of Adverse Events||10 days post surgery plus or minus 3 days||||number of events|||Number
1342202|NCT01919606|Primary|Duration of Analgesia||End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)|||||||
1342203|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|1 minute||||Ratio||Standard Deviation|Mean
1342204|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|10 seconds||||Ratio||Standard Deviation|Median
1342205|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|2 mintues||||Ratio||Standard Deviation|Mean
1342206|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|4 minutes||||Ratio||Standard Deviation|Mean
1342207|NCT01919307|Secondary|Trend for Auricular Acupuncture to Reduce NES Frequency|Of subjects completing the 8 week active treatment period, we will compare each subject’s 1 month baseline frequency with frequency immediately upon completion of the active treatment period, and at 1 month follow up (3 months after baseline)|16 weeks||||Number of Seizures per Week||Standard Deviation|Mean
1342208|NCT01919307|Secondary|Compliance Rates of NES Seizure Diary|For each subject enrolled, we will measure the percentage of diary entries each patient completed over the four month study period.|16 Weeks||||percentage of completed diary entries||Standard Deviation|Mean
1342209|NCT01919307|Secondary|Adverse Events|We will report the types and rates of any adverse events collected from subject diaries.|16 Weeks||||Adverse Events|Adverse Events||Count of Units
1342210|NCT01919307|Primary|Completion Rate of Auricular Acupuncture in Patients With NES|Of subjects who receive the first Auricular Acupuncture treatment, we will measure the percentage that goes on to complete the entire 8 week active treatment period.|8 Weeks||||Participants|||Count of Participants
1342211|NCT01919229|Secondary|Change From Baseline in Expression of Cyclin-Dependent Kinase 1 (CDK1)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.||||||
1342212|NCT01919229|Secondary|Correlation Between PK Concentrations and ECG Changes|Correlation between the QTc interval change from baseline and plasma concentrations of LEE011 and/or any relevant metabolites|Day 14|Since the study was terminated, no efficacy data was obtained.||||||
1342213|NCT01919229|Secondary|Change in ECG Morphology||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.||||||
1342214|NCT01919229|Secondary|PK (Pharmacokinetics) Parameters, Including But Not Limited to, Cmax, Tmax, AUClast for LEE011 (and Any Relevant Metabolites) and Letrozole.||Days 1, 8, 14 and 15|Since the study was terminated, no efficacy data was obtained.||||||
1342215|NCT01919229|Secondary|Change From Baseline in Expression of Retinoblastoma Protein (pRB)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.||||||
1342216|NCT01919229|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.||||||
1342217|NCT01919229|Secondary|Safety and Tolerability of the Combination|Occurrence, frequency and severity of adverse events (AEs), laboratory abnormalities|Up to 30 days after the last dose|Since the study was terminated, no efficacy data was obtained, but see Adverse Events (AE) section for all AEs collected.|||Participants|||Number
1342218|NCT01919229|Primary|Cell Cycle Response Rate Per Cell Proliferation Marker Ki67|Cell cycle response rate is defined by proportion of patients with natural logarithm of Ki-67 levels (expressed as percentage of baseline values) of less than 1 at the time of surgery. Since the trial was prematurely terminated, no statistical analysis was done.|Day 1, Day15|Since the study was terminated, no efficacy data was obtained.||||||
1342219|NCT01919216|Primary|Hamilton Rating Scale for Depression|The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-9 is considered to be normal. Score between 10-18 is considered as mild depression, Scores between 19-26 indicate moderate, scores between 27-34 indicate severe, and score between 35-75 indicate very severe depression.|8 weeks|54 subjects participated in the study, of whom 4 (2 in open track, 1 in placebo track - citalopram, 1 in placebo track - placebo) were lost to follow-up prior to taking the study medication and were excluded from the analyses.|||units on a scale||Standard Deviation|Mean
1342220|NCT01918800|Secondary|Timed 25 Foot Walk (T25-FW)|The time to walk 8 meters or 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r = 0.91), without the variability that the ordinal scale reflects.T25-FW was used in this study to measure ambulation status and as an additional measure of mobility. The score for the T25-FWis the average of the two completed trials in seconds|4 months||||seconds||Standard Deviation|Mean
1342263|NCT01918332|Primary|sitDBP Changes at Week 8 From Baseline|sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline|8 weeks|FAS|||mmHg||95% Confidence Interval|Least Squares Mean
1342221|NCT01918800|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score between 0-21. Higher scores indicate worse sleep quality."|4 months||||units on a scale||Standard Deviation|Mean
1342222|NCT01918800|Secondary|Rapid Assessment of Physical Activity (RAPA)|"The self-report, retrospective Rapid Assessment of Physical Activity (RAPA) was developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. The RAPA is an easy-to-use, valid measure of physical activity for use in clinical practice with older adults. A tool for older adults will be easy to use for people with MS who may not be regular exercisers. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. From these values we provided a percentage of the number of people exercising optimally in the RAPA Cardiovascular.~Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3). Based on total scores we provided a percentage of people at optimum strength and flexibility."|4 months||||Participants|||Count of Participants
1342223|NCT01918800|Secondary|SF-36|The SF-36 is a validated measure of health-related quality of life. It is sensitive to change, has appropriate psychometric properties and is frequently used in MS studies. Measures of health-related quality of life are recommended in the systematic review of self-management in neurological disorders. The range for the physical component score is 13.6-61.9. The range for the mental component scores is 15.6-70.0.|4 months||||units on a scale||Standard Deviation|Mean
1342224|NCT01918800|Secondary|Beck Depression Inventory II (BDI-II)|The self-report, retrospective BDI-II is a validated 21-item self-report measure of depression widely used in MS studies . Each item is scored between 0 and 3. It is reported to have good reliability (Cronbach's alpha of .81) and validity. Assessing for depression is part of the inclusion/exclusion criteria. Excluding subjects with severe depression is necessary to avoid confounding effects of fatigue and depression. Score range (0-63). Higher scores indicate greater depression.|4 months||||units on a scale||Standard Deviation|Mean
1342225|NCT01918800|Secondary|Multiple Sclerosis Self Efficacy Scale|The self-report, retrospective MSSE is an 18-item scale of self-efficacy specifically designed for MS patients. This easy to use self-report measure demonstrates internal consistency estimates of about .89 for the full scale and a .75 test-retest correlation. Higher scores on the MSSE indicate higher self-efficacy. Scores range from 180-1800.|4 months||||units on a scale||Standard Deviation|Mean
1342226|NCT01918800|Primary|Modified Fatigue Impact Scale|The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.|4 months||||units on a scale||Standard Deviation|Mean
1342227|NCT01918371|Secondary|Percentage of Phakic Patients With Cataract Surgery in the Study Eye|Phakic patients have intraocular lens implants.|4 Years|All phakic participants with data available.|||percentage of participants|||Number
1342228|NCT01918371|Secondary|Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
1342229|NCT01918371|Secondary|Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
1342230|NCT01918371|Secondary|Percentage of Participants With No Change in BCVA From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342231|NCT01918371|Secondary|Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A gain of 1 or more lines read correctly from Baseline indicates an improvement of vision.|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342232|NCT01918371|Secondary|Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A loss of 1 or more lines read correctly from Baseline indicates a worsening of vision.|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342233|NCT01918371|Secondary|Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
1342234|NCT01918371|Secondary|Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
1342235|NCT01918371|Secondary|Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye|Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342236|NCT01918371|Secondary|Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye||UP to 4 Years|All participants with data available.|||percentage of participants|||Number
1342237|NCT01918371|Secondary|Number of Intravitreal Anti-VEGF Injections in the Study Eye|To be included in the time period analysis, patients must have been enrolled on the study for at least a minimum of 0 weeks, 24 weeks, 50 weeks, 100 weeks, and 150 weeks, respectively, and must have received at least 1 injection during that time period.|0-6 Months, 7-12 Months, Years 1,2,3|All participants with data available.|||injections||Standard Deviation|Mean
1342238|NCT01918371|Secondary|Time Between Anti-VEGF Injections in the Study Eye|The mean time in months between anti-VEGF Injections.|4 Years|All participants with data available.|||months||Standard Deviation|Mean
1342239|NCT01918371|Secondary|Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.|||months||Full Range|Median
1342240|NCT01918371|Secondary|Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement in months in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.|||months||Full Range|Median
1342241|NCT01918371|Secondary|Time to Improvement in BCVA to 20/40 or Better in the Study Eye|Kaplan-Meier estimates of the time to Improvement in months in BCVA to 20/40 or Better. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly.|4 Years|All participants with available data.|||months||Full Range|Median
1342242|NCT01918371|Secondary|Time to Improvement of ≥3 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥3 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.|||months||Full Range|Median
1342243|NCT01918371|Secondary|Time to Improvement of ≥2 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥2 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.|||months||Full Range|Median
1342244|NCT01918371|Secondary|Change From Baseline in CRT by OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.|||µm (microns)||Standard Deviation|Mean
1342245|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342246|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years||||percentage of participants|||Number
1342247|NCT01918371|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A positive change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.|||lines||Standard Deviation|Mean
1342248|NCT01918371|Secondary|Mean BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|UP to 4 Years|All participants with data available.|||lines||Standard Deviation|Mean
1342249|NCT01918371|Secondary|Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342250|NCT01918371|Secondary|Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342251|NCT01918371|Secondary|Percentage of Participants With BCVA of 20/40 or Better in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
1342252|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 11 (Up to 4 Years)|All participants with data available up to time of Injection 11.|||percentage of participants|||Number
1342264|NCT01918306|Other Pre-specified|Correlation of the Presence of PIK3CA Mutations in the Tumor With Time to Tumor Progression.|Examining tumor tissue for PI3K mutations and correlating this statistically with clinical outcomes including time to tumor progression.|2 years|||||||
1342308|NCT01917344|Primary|Phenylalanine Level in the Brain as Determined by MR Spectroscopy and in Blood|Brain Phe levels (umol/L) using MRI correlated spectroscopy and Blood Phe levels (umol/L) obtained on the same day.|During period of evaluation, approximately 8 hours||||umol/L||Standard Deviation|Mean
1342253|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 10 (Up to 4 Years)|All participants with data available up to time of Injection 10.|||percentage of participants|||Number
1342254|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 9 (Up to 4 Years)|All participants with data available up to time of Injection 9.|||percentage of participants|||Number
1342255|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 8 (Up to 4 Years)|All participants with data available up to time of Injection 8.|||percentage of participants|||Number
1342256|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 7 (Up to 4 Years)|All participants with data available up to time of Injection 7.|||percentage of participants|||Number
1342257|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 6 (Up to 4 Years)|All participants with data available up to time of Injection 6.|||percentage of participants|||Number
1342258|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 5 (Up to 4 Years)|All participants with data available up to time of Injection 5.|||percentage of participants|||Number
1342259|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 4 (Up to 4 Years)|All participants with data available up to time of Injection 4.|||percentage of participants|||Number
1342260|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 3 (Up to 4 Years)|All participants with data available up to time of Injection 3.|||percentage of participants|||Number
1342261|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 2 (Up to 4 Years)|All participants with data available up to time of Injection 2.|||percentage of participants|||Number
1342262|NCT01918332|Primary|LDL-C Percentage Changes at Week 8 From Baseline|LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline|8 weeks|FAS|||percent change||95% Confidence Interval|Least Squares Mean
1342266|NCT01918306|Secondary|Clinical Benefit Rate - (Phase II)|"Clinical Benefit Rate (CBR) is defined as complete response (CR) plus partial response (PR) plus stable disease (SD) for 6 months.~Clinical Benefit Rate (CBR) is calculated with the corresponding 95% confidence intervals at the dose recommended for phase II.~Response and progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 performed at baseline and every 8 weeks will be compared."|at 32 weeks|Study closed early and response and progression were not evaluated at 32 weeks.||||||
1342267|NCT01918306|Secondary|Number of Patients With Dose-limiting Toxicities Per NCI Common Terminology for Adverse Events (CTCAE) - (Phase Ib)|Number of patients with Grade 3 and 4 toxicities per NCI Common Terminology for Adverse Events (CTCAE) version 4.0 requirements.|During the first 4 weeks|Less than 2 patients in cohort 1 and 2 experienced DLT, therefore no patients enrolled in arm 1PHIbB.|||participants|||Number
1342268|NCT01918306|Primary|Percentage of Patients Achieving Overall Response - (Phase II)|"The primary efficacy endpoint is overall response rate (ORR) of cisplatin + GDC-0941 versus cisplatin alone in patients with AR- TN MBC. ORR is defined as the percentage of subjects achieving complete response (CR) plus partial response (PR) as their best response by RECIST version 1.1 for targeted lesions and assessed by CT, MRI scan.~Objective responses, was estimated by the overall tumor burden at baseline (targeted lesions) in which subsequent measurements were performed every 8 weeks using the Solid Tumor Response Criteria (RECIST) v1.1 were compared. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|at 8 weeks|Phase 1-Initial and Max tolerated dose of GCD-0941 was the same, no dose de-escalation occurred. Phase 2, 1 of the 2 patients from the Cisplatin only arm did crossover to the Crossover Cisplatin and GDC-0941 arm. 3 patients randomized to Cisplatin + GDC -0941 arm, and 1 crossover patient, for a total of 4 patients who received Cisplatin+GDC-0941.|||Participants|||Count of Participants
1342269|NCT01918306|Primary|Maximum Tolerated Dose(MTD) of GDC-0941 and Recommended Phase II Dose of GDC-0941 Given in Combination With Cisplatin. - (Phase Ib)|"GDC-0941 dose will start at 260 mg (maximum dose). De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level of GDC-0941 260mg.~MTD is defined as the highest dose at which a DLT is experienced >= 1 out of 6 patients.~A cohort of 3 patients was initially enrolled in the GDC-0941 arm at dose 260mg PO days 2-6, 9-13, 16-20, 23-27 of 28 day cycle~If no patient in the first cohort of 3 experiences a DLT, an additional cohort of 3 patients will be treated at the same dose level.~If 1 patient experiences a DLT in the first cohort, an additional cohort of 3 patients will be treated at the same dose level.~If ≤1 patient has a DLT in 6 treated at this same dose, this will be considered a tolerable dose to move to phase II.~If 2 or more patients in 3 or 6 patients treated at a given dose experience DLT, the dose will be de-escalated to the next lower dose level."|4 weeks|A cohort of 3 was enrolled at dose 260mg. No DLT was found. Then a second cohort of 260mg was enrolled. One of them experienced DLT.|||mg|||Number
1342270|NCT01918085|Primary|Peel Force|"The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees.~The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects."|1 hour|"Some of the measurements failed. i.e one subject was a wheel chair user and the peel force could not be measured on this person.~Only the measurements that did not fail were included in the analysis"|||Newton||Standard Deviation|Mean
1342271|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342272|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342273|NCT01918033|Secondary|Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator|The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342274|NCT01918033|Secondary|Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator|The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.|Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.|||Participants|||Number
1342275|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Assessed by the Investigator|The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342276|NCT01918033|Secondary|Change From Baseline in Nasal Finding Score Assessed by the Investigator|The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342277|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342278|NCT01918033|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342279|NCT01918033|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to Week 2|The ASaT population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1342280|NCT01918033|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to Week 4|The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1342281|NCT01918033|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Week 2|The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342282|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)||||minutes per day||Standard Deviation|Mean
1342283|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)||||minutes per day||Standard Deviation|Mean
1342345|NCT01916590|Primary|Pain Scores Will be Collected for 48 Hours After ACL Reconstruction|Pain scores will be collected for 48 hours after ACL reconstruction with a patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block|48 hours after surgery|Because of the lack of enrollment no data was collected||||||
1342285|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|"Defined as the time spent walking continuously for >10 minutes without breaking for more than a minute.~Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts."|Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)||||minutes per day||Standard Deviation|Mean
1342286|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)||||minutes per day||Standard Deviation|Mean
1342287|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)||||steps per day||Standard Deviation|Mean
1342288|NCT01917773|Primary|Compared Colonic Motility Index From Fasting to Post Octreotide Infusion|"Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH).~Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes."|Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.||||mm Hg||95% Confidence Interval|Mean
1342289|NCT01917656|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.|"A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events.~Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable"|Day -1 to day 29|Safety analysis set|||Events/1000 years of patient exposure|||Number
1342290|NCT01917656|Secondary|Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.||Day -1 to day 29|Safety analysis set|||Events/1000 years of patient exposure|||Number
1342291|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set|||percentage (%) of subjects|||Number
1342292|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set|||percentage (%) of subjects|||Number
1342293|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Body Weight||Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||kg||Standard Error|Least Squares Mean
1342294|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)|The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1342295|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Fasting Plasma Glucose|The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||mmol/L||Standard Deviation|Mean
1342296|NCT01917656|Secondary|Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)|The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||mmol/L||Standard Deviation|Mean
1342297|NCT01917656|Secondary|Fructosamine at End of Ramadan|The fructosamine values at the end of Ramadan (visit 12) were presented|Day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||umol/L||Standard Deviation|Mean
1342298|NCT01917656|Primary|Change in Fructosamine From Start of Ramadan to End of Ramadan|The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12).|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||umol/L||Standard Deviation|Mean
1342299|NCT01917526|Secondary|The Causes of Hypoxemia|Causes of hypoxemia in each participant in PACU will be recorded|In PACU (1 hr after anesthesia)||||causes of hypoxemia|||Number
1342309|NCT01917214|Secondary|Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different durations of treatment with Sutent were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified treatment duration.|||participants|||Number
1342310|NCT01917214|Secondary|Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|"Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different Sutent doses were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. Here other refers to Sutent 12.5 mg."|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified Sutent treatment.|||participants|||Number
1342311|NCT01917214|Secondary|Time to Treatment Failure From Initiation of Sutent Therapy|Time to treatment failure was defined as the time from initiation of study treatment to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason. PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “N” (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1342312|NCT01917214|Secondary|Overall Survival (OS)|Overall survival was the duration from diagnosis of disease to death. Overall survival was compared for those who had received best supportive care to those who received Sutent as first-line therapy.|From diagnosis until death (up to 72 months)|Participants diagnosed with mRCC during time period between 1 January 2006 and 31 December 2011 and received Sutent or Best Supportive Care as a first-line therapy. Here, “N” (number of participants analyzed)=participants who were evaluable for this outcome measure. “n”=participants who were evaluable for this measure for each specified treatment.|||months||95% Confidence Interval|Median
1342313|NCT01917214|Secondary|Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) as per clinical and radiological documentation in clinical notes. CR was defined as complete resolution of all visible disease, whereas PR was defined as partial reduction in size of visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy.|||percentage of participants|||Number
1342314|NCT01917214|Primary|Progression-Free Survival (PFS) From Initiation of Sutent Therapy|PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study.|From initiation of treatment up to 72 months|Time to treatment failure (given in outcome measure 4) was used as a surrogate for PFS due to the lack of consistent regular restaging scans in clinical practice.||||||
1342315|NCT01916980|Secondary|Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=Worst imaginable itch) at Baseline and subsequent clinic visits. Pruritus/itch VAS scores could range from 0 to 100, with a higher score indicating more severe pruritus/itching. The changes from Baseline in the VAS scores for pruritus/itch at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for participant-assessed pruritus/itch VAS score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342316|NCT01916980|Secondary|Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch. The Investigator assessed the degree of severity of pruritus/itch based on 5 grades (1=Remarkably improved to 5=Aggravated) at Baseline and subsequent clinic visits. The percentages of participants who were remarkably improved (Grade 1=Pruritus/itch disappeared) or moderately improved (Grade 2=Pruritus/itch was greatly improved) at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed Global Improvement.|||Percentage of Participants|||Number
1342335|NCT01916824|Primary|Money Earned|"Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical “points” that do not have meaning in the real world. Greater earnings indicate better financial decision-making.~The specific tasks were:~risk task~balloon analogue risk task~temporal discounting task~ultimatum game~continuous performance task"|Baseline, Week 6|The population at each time point includes the number of participants completing the each visit.|||US Dollars||Standard Deviation|Mean
1342317|NCT01916980|Secondary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime pruritus/itch scores at the Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342318|NCT01916980|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 12 weeks|The APaT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1342319|NCT01916980|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 14 weeks (Up to 2 weeks after last dose dose of study drug)|The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1342320|NCT01916980|Primary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342321|NCT01916967|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for DLQI|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342322|NCT01916967|Secondary|Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342323|NCT01916967|Secondary|Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2|Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342324|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342336|NCT01916681|Secondary|Maternal Morbidity||Enrollment through discharge||||participants|||Number
1342337|NCT01916681|Secondary|Chorioamnionitis||Enrollment through deischarge||||participants|||Number
1342338|NCT01916681|Secondary|Regional Anesthesia||During delivery||||participants|||Number
1342325|NCT01916967|Secondary|Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Participants|||Number
1342326|NCT01916967|Secondary|Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342327|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342328|NCT01916967|Secondary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342329|NCT01916967|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 2 weeks|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.|||Participants|||Number
1342330|NCT01916967|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.|||Participants|||Number
1342331|NCT01916967|Primary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1342332|NCT01916941|Primary|Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)||from 2-4 weeks and from 4-6 weeks||||drinks per week||Standard Deviation|Mean
1342333|NCT01916928|Secondary|The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.||3-4 weeks after specimen processing|||||||
1342334|NCT01916928|Primary|The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.|Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise|During initial presentation for treatment||||percentage of participants|||Number
1342339|NCT01916681|Secondary|Time to Active Labor||Start of induction to active labor||||Hours||Inter-Quartile Range|Median
1342346|NCT01916304|Secondary|Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone|Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.|||percent change||Inter-Quartile Range|Median
1342347|NCT01916304|Secondary|Absolute Serum Thyroid Stimulating Hormone Values|Blood samples were collected and samples were analyzed according to the local Quality System.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.|||mIU/mL||Inter-Quartile Range|Mean
1342348|NCT01916304|Secondary|Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L|Blood samples were collected and samples were analyzed according to the local Quality System.|Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.|||percentage of participants|||Number
1342349|NCT01916304|Secondary|Magnitude of the Change in Daily Dose Needed|Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.|||percentage of participants|||Number
1342350|NCT01916304|Primary|Percentage of Participants That Do Not Need a Change of Dose|Dose change was determined by physician according to their clinical judgement.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1342351|NCT01916226|Secondary|Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period|The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days.|Baseline through the entire treatment period (2 weeks)|Ocular Population. Change from Baseline was calculated as the 2-week average minus the Baseline value.n|||Scores on a scale||Standard Error|Mean
1342352|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period|The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that “instant.” The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Ocular Population|||Scores on a scale||Standard Error|Mean
1342353|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period|The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Ocular Population: all ITT participants with a Baseline rTOSS of 4 or greater|||Scores on a scale||Standard Error|Mean
1342354|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period|The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that “instant.” The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days.|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2. Change from Baseline was calculated as the 2-week average minus the Baseline value.|||Scores on a scale||Standard Error|Mean
1342437|NCT01913600|Secondary|Clinical Endpoint: Bleeding Complications in General|Bleeding complications in general including the GUSTO classification of Severe, Moderate & Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342355|NCT01916226|Secondary|Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.|The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value.|Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal|ITT Population|||Scores on a scale||Standard Error|Mean
1342356|NCT01916226|Secondary|Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period|Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.|||Scores on a scale||Standard Error|Mean
1342357|NCT01916226|Primary|Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period|The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days’ worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.|||Scores on a scale||Standard Error|Mean
1342358|NCT01916109|Primary|Pathologic Complete Response Rate (<pT0)|The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|1 year||||participants|||Number
1342359|NCT01915940|Secondary|Change From Baseline in IOP at Month 6|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Month 6|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
1342360|NCT01915940|Secondary|Change From Baseline in IOP at Month 5|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Month 5|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
1342361|NCT01915940|Secondary|Change From Baseline in IOP at Month 4|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 1) to Month 4|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
1342362|NCT01915940|Primary|Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Week 12|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
1342363|NCT01915940|Primary|Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Week 6|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
1342364|NCT01915940|Primary|Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Week 2|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
1342365|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using the Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each sign (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Maintenance Phase and Follow-up Phase and is calculated as the score at the end of the Maintenance and Follow-up Phase minus the Baseline score. Baseline is defined as VAS score for each sign obtained at Visit 4 (end of Acute Phase). Summation of VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at the Maintenance and Follow-up phase of study. The missing value was imputed using last-observation-carry-forward (LOCF) method.|Baseline, Week 20 and Week 32|ITT Population|||Scores on a scale||Standard Deviation|Mean
1342366|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each signs (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Acute Phase (Visit 4 [Week 0 or treatment success, depend on which time point comes first) ±2day]) and is calculated as the score at Visit 4 minus the Baseline score. Baseline is defined as the VAS score for each sign obtained before the first dose of study drug in the Acute Phase of the study (Visit 2). Summation of the VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at Visit 4 of the Acute Phase of the study.|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population|||Scores on a scale||Standard Deviation|Mean
1342367|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: It leaves my skin feeling soft and smooth; Q 2: There is nothing left on my skin; Q 3: Does not feel greasy; Q 4: Disappears into my skin quickly after I put it on; Q 5: Easy to apply; Q 6: Fragrance-free; Q 7: Spreadability; Q 8: Lack of stickiness. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree, 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population|||Participants|||Number
1342368|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: This product is easier to use than other skin emollients; Q 2: When I apply this product I am able to start my daily activities quicker than with other skin emollients; Q 3: This product leaves my skin feeling softer than other skin emollients; Q 4: I am able to apply this product to larger body surface areas than other skin emollients; Q 5: This product disappears into my skin quicker than when I apply other skin emollients. Participants rated the qualities of the lotion based on a 5 point scale (5= “Strongly Agree”, 4= “Agree”, 3= “Neutral”, 2= “Disagree, 1= “Strongly Disagree” N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|Enrolled Population|||Participants|||Number
1342369|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire|Participants from each group completed the post-study questionnaire to rate the skin emollients (gel, lotion, cream, ointment, solution and foam) used in the past based on their experience. Participants rated skin emollients on a 5-point scale (5= “liked the best”, 4= “second best”, 3= “third best”, 2= “fourth best, 1= “liked the least”, N/A=Does not apply to me).|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population|||Participants|||Number
1342370|NCT01915914|Secondary|Change From Baseline in QoL at the End of the Follow-up Phase|Infant's IDQOL and Children's CDLQI were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with AD, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in QoL score is based on each questionnaire at the end of the Follow-up Phase and is calculated as the score at the end of the Follow-up Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 32|ITT Population|||Scores on a scale||Standard Deviation|Mean
1342403|NCT01914757|Secondary|Immunogenicity of Benralizumab|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.|Pre-treatment until end of follow-up|Safety analysis set|||Participants|||Number
1342371|NCT01915914|Secondary|Change From Baseline in Quality of Life (QoL) at the End of the Maintenance Phase|Infant's Dermatitis Quality of Life Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with atopic dermatitis, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in the QoL score is based on each questionnaire at the end of the Maintenance Phase and is calculated as the score at the end of the Maintenance Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 20|ITT Population|||Scores on a scale||Standard Deviation|Mean
1342372|NCT01915914|Secondary|Number of Participants With “Treatment Success” During the Acute Phase|"The number of participants with treatment success” during the Acute Phase is presented. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to Baseline in the Acute Phase of the study."|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population: all participants who were enrolled into the Acute Phase of the study.|||Participants|||Number
1342373|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Follow-up Phase (Week 32)|The number of participants with AD recurrent/relapse at the end of the Follow-up Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 20 to Week 32|ITT Population|||Participants|||Number
1342374|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Maintenance Phase (Week 20)|The number of participants with AD recurrent/relapse at the end of Maintenance Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 0 (or treatment success, if earlier) to Week 20|ITT Population|||Participants|||Number
1342375|NCT01915914|Secondary|Median Time to the First Relapse of AD During the Maintenance Phase and Follow-up Phase|Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase is defined as the number of days from start of the FP treatment until AD relapse during the Maintenance Phase and Follow-up Phase. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during the Acute Phase.|From the start of treatment up to Week 32 during the Maintenance Phase and Follow-up Phase|ITT Population. Only participants avilable at the specified time point were analyzed.|||Days||95% Confidence Interval|Median
1342376|NCT01915914|Primary|Time to the First Relapse of AD During the Maintenance Phase|Time to the first relapse of AD is defined as the number of days from start of the FP treatment in Maintenance Phase until AD relapse. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during Acute Phase. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From the start of treatment up to Week 20 during the Maintenance Phase|ITT Population: all participants who were randomized into the Maintenance Phase. Only participants available at the specified time point were analyzed.|||Days||95% Confidence Interval|Median
1342377|NCT01915849|Primary|Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose|Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.|Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)|The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||(umol/kg FFM/min)*hr||Standard Deviation|Mean
1342378|NCT01915823|Other Pre-specified|Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)|Change from baseline to Visit 4 in the ITT ( intent to treat) Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects equal to or greater than 6 years old and less than12 years old compared to placebo.Scored on a 0 to 7 scale with 0 being not troubled at all and 7 being extremely troublesome. The higher the difference the better the result.|day 1 to day 15 of treatment||||units on a scale||Standard Deviation|Mean
1342379|NCT01915823|Secondary|Safety|"Subject-reported adverse experiences (incidence, type, and severity of adverse events)~Nasal Examinations~Vital signs assessments"|entire length of study (day 1 to day 22)||||occurance|||Number
1342380|NCT01915823|Primary|Primary Efficacy|change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.|15 days of treatment||||units on a scale||Standard Deviation|Mean
1342404|NCT01914757|Secondary|Pharmacokinetics of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1342381|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|PP Population|||Participants|||Number
1342382|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|ITT Population|||Participants|||Number
1342383|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population|||Percent change in lesions||Standard Error|Least Squares Mean
1342384|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population|||Percent change in lesions||Standard Error|Least Squares Mean
1342385|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population|||Lesions||Standard Error|Least Squares Mean
1342386|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population|||Lesions||Standard Error|Least Squares Mean
1342387|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .|Baseline (Week 0) and Week 12|PP Population|||Participants|||Number
1342388|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population|||Participants|||Number
1342389|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.|||Change in lesion count||Standard Error|Least Squares Mean
1342405|NCT01914757|Secondary|Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations|Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Events/year||95% Confidence Interval|Least Squares Mean
1342390|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.|||Change in lesion count||Standard Error|Least Squares Mean
1342391|NCT01915173|Secondary|GERD Health-Related Quality of Life at Follow-up|The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.|Two weeks|All enrolled study participants.|||units on a scale||Standard Deviation|Mean
1342392|NCT01915173|Secondary|Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity|Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.|Second week of the trial compared to pre-trial baseline|All enrolled study participants.|||participants|||Number
1342393|NCT01915173|Primary|Safety - Number of Participants Experiencing a Serious Adverse Event|Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.|2 week follow-up|All enrolled study participants.|||participants|||Number
1342394|NCT01915108|Primary|Number of Patients With Adverse Events Following LMA Removal|All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.|from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.||||participants|||Number
1342395|NCT01914926|Primary|Percent of Patients Reaching Target HR<100bpm Within 30 Minutes|Percent of patient who reached a HR<100bpm within 30 minutes from baseline.|30 minutes||||percentage of participants|||Number
1342396|NCT01914757|Secondary|Patient and Clinician Assessment of Response to Treatment|CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
1342397|NCT01914757|Secondary|Number of Participants That Utilized Health Care Resources||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
1342398|NCT01914757|Secondary|Mean Productivity Loss Due to Asthma in Classroom|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who took classes|||percent of productivity loss||Standard Deviation|Mean
1342399|NCT01914757|Secondary|Mean Work Productivity Loss Due to Asthma|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who were employed|||Percent of productivity loss||Standard Deviation|Mean
1342400|NCT01914757|Secondary|Change From Baseline to Week 56 in EQ-5D-5L VAS|EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
1342401|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in AQLQ(S)+12|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
1342402|NCT01914757|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment in days|Immediately following the first administration of study drug through Study Week 56|Safety analysis set|||Days||Standard Deviation|Mean
1342406|NCT01914757|Secondary|Time to First Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
1342408|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
1342409|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
1342410|NCT01914757|Secondary|Proportion of Nights With Awakening Due to Asthma|Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Proportion of nights||Standard Deviation|Mean
1342411|NCT01914757|Secondary|Home Lung Function Assessments Based on PEF|Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||L/min||Standard Deviation|Mean
1342412|NCT01914757|Secondary|Change in Asthma Rescue Medication Use|Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Puffs per day||Standard Deviation|Mean
1342413|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
1342414|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
1342415|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS|||Liter||Standard Deviation|Mean
1342416|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Liter||Standard Deviation|Mean
1342417|NCT01914757|Secondary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS.|||Events/year||95% Confidence Interval|Least Squares Mean
1342418|NCT01914757|Primary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS.|||Events/year||95% Confidence Interval|Least Squares Mean
1342419|NCT01914679|Other Pre-specified|fMRI Measures of Network Connectivity|Subjects will undergo a neuroimaging scan at Baseline (week 1), week 6, and week 18. The scan will measure network connectivity during stimuli.|Baseline (week 1), week 6, and week 18|||||||
1342420|NCT01914679|Other Pre-specified|Investigate Changes in Neurocognitive Functioning Using the MASQ and MCS Assessments.|The MASQ and MCS questionnaires will be administered at Baseline (week 1), week 6, week 10, week 14, week 18 and week 21.|Baseline and up to 21 weeks|||||||
1342421|NCT01914679|Other Pre-specified|Change in Network Connectivity as Measured by EEG|EEGs will be measured at the baseline, week 4, week 18 and week 21 visits.|Baseline (week 1), week 6, week 18 and week 21|||||||
1342422|NCT01914679|Primary|Change in Patient 24-hour Recall Average Pain Intensity|The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable.|Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)|One participant missing from analysis at Week 14/Mid-Treatment/Visit 27 due to missed visit.|||units on a scale||Standard Deviation|Mean
1342423|NCT01914666|Secondary|Number of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Week 53|All the enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1342424|NCT01914666|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline, Week 53|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.LOCF was used.|||participants|||Number
1342425|NCT01914666|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50|BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Deviation|Mean
1342426|NCT01914666|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Deviation|Mean
1342427|NCT01914666|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50|SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.|||units on a scale||Standard Deviation|Mean
1342428|NCT01914666|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50|RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.|||units on a scale||Standard Deviation|Mean
1342429|NCT01914666|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.|||units on a scale||Standard Deviation|Mean
1342430|NCT01914666|Secondary|Patient Global Impression of Improvement (PGI-Improvement) to Week 50|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Deviation|Mean
1342431|NCT01914666|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50|A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 50|(FAS): All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1342432|NCT01914666|Primary|Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE’s|A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Week 53|All the enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1342433|NCT01914003|Primary|Prevalence of CSID Genetic Variants|Prevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation.|1 year||||Participants|||Number
1342434|NCT01913795|Secondary|Lung Function|peak expiratory flow (PEF)|measured at baseline and months 6 and 12|The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.|||Liters/second||Standard Error|Mean
1342435|NCT01913795|Primary|Asthma Symptoms|number of days of wheezing/cough|over a two week period at Baseline and Months 3, 6, 9 and 12|The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.|||Days||Full Range|Mean
1342436|NCT01913600|Secondary|Dual Antiplatelet Therapy (DAPT) Compliance|Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.|30 days, 6 months, 12 months|At the time of the 12 month follow up there were 52 subjects with evaluable data|||Participants|||Count of Participants
1342903|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mEq/L||Standard Deviation|Mean
1342438|NCT01913600|Secondary|Clinical Endpoint: Stroke|Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342439|NCT01913600|Secondary|Clinical Endpoint: Stent Thrombosis|All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions|Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342440|NCT01913600|Secondary|Clinical Endpoint: Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342441|NCT01913600|Secondary|Clinical Endpoint: Target Lesion Revascularization (TLR)|Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342442|NCT01913600|Secondary|Clinical Endpoint: Myocardial Infarction (MI)|All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342443|NCT01913600|Secondary|Clinical Endpoint: Death|All deaths including cardiac death, vasular death and non-cardiovascular death|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342444|NCT01913600|Secondary|Composite Endpoint: Target Vessel MI|Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342445|NCT01913600|Secondary|Composite Endpoint: Cardiac Death and Target Vessel MI|Combined rate of cardiac death and target vessel MI post-procedure|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342446|NCT01913600|Secondary|Composite Endpoint: Target Vessel Failure (TVF),|The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342447|NCT01913600|Secondary|Composite Endpoint: Target Lesion Failure (TLF)|Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342448|NCT01913600|Secondary|Composite Endpoint: Major Adverse Cardiac Events (MACE)|Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342449|NCT01913600|Primary|Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)|The combined clinical outcome of (all cause) mortality, MI or any revascularization|12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
1342450|NCT01913535|Secondary|Number of Participants With Clinically Significant Abnormal Labs|Total number of participants with clinically significant abnormal labs|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||Participants|||Count of Participants
1342451|NCT01913535|Secondary|Number of Participants With Clinically Significant Abnormal ECG|Number of Participants with clinically significant abnormal electrocardiogram (ECG)|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||Participants|||Count of Participants
1342452|NCT01913535|Secondary|Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS will be performed to assess suicidal ideation and behavior. It contains a 5-item rating scale for suicidal ideation and a 7-item rating scale for suicidal behavior. Higher total scores indicate higher severity. Each item is coded 1=yes, 0=no, so a total score of 0 on each scale means that a no response was entered for each of the 5 suicidal ideation and for each of the 7 suicidal behavior questions, i.e., 0=lowest severity score. Total suicidal ideation score ranges from 0 (least severe) to 5 (most severe). Total suicidal behavior score ranges from 0 (least severe) to 7 (most severe).|Baseline and 72 hours after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria. 1 CERC-501 pt and 3 placebo pts are missing data on 72-hr change values.|||units on a scale||Full Range|Median
1342466|NCT01913470|Other Pre-specified|Change in Aspartate Aminotransferase (AST) From Baseline to End of Treatment|The normal range for AST in children is 0 - 60 IU/L. AST can respond rapidly to treatment so decreases between Baseline and subsequent measurements indicate positive effects of treatment.|Baseline, Week 8, Week 14, and Week 22|In this blinded, crossover treatment, study participants received losartan or a placebo for 8 weeks, then completed a 6 week washout period before crossing over to the other treatment for 8 weeks. The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment.|||IU/L||Standard Deviation|Mean
1342904|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mEq/L||Standard Deviation|Mean
1342453|NCT01913535|Secondary|Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities|"These are two well-validated 7-item self-rating scales that measure social health. A higher score represents higher satisfaction on each scale. The scales are rated based on the past 24 hours. Each item is rated 1-5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Each 7-item subscale score is the sum of each of the 7 items and ranges from 7-35.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
1342454|NCT01913535|Secondary|Change in Positive Affect Scale (PAS)|"This is a validated, self-rated measure of positive affect uses 5-point scales (1 = very slightly/not at all to 5 = extremely). Higher scores represent higher levels of positive affect. The scale is rated based on the past 24 hours. The total score is the sum of 10 items, for a range of 10-50.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responder data is included from phase 2 and is pooled with phase 1. All phase 1 placebo participants were non-responders based on HAM-D-6 and MADRS criteria.The 20-day analyses only use drug-drug (either dose) and placebo-placebo arms. 1 pt missing PAS data.|||units on a scale||Full Range|Median
1342455|NCT01913535|Secondary|Change in Perceived Stress Scale (PSS)|"This is a 10-item, validated, self-rated measure of perceived stress, that is of the degree to which the subjects perceives things to be stressful and overwhelming. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. This scale is rated based on the past 24 hours.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responders are included from phase 2 and are pooled with phase 1. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. 2 pts missing 72-hr PSS values. The 20-day analyses only use drug-drug and placebo-placebo arms.|||units on a scale||Full Range|Median
1342456|NCT01913535|Secondary|Change in Symptoms of Depression Questionnaire (SDQ)|"This validated self-rating instrument has 44 items on a scale of 1-6, measuring multiple depressive symptom domains. Each item is rated based on a subject's perception of what is normal for the individual (score = 2), what is better than normal (score = 1), and what is worse than normal (scores = 3–6). This scale is rated based on the past 24 hours. A total score is calculated by summing the 44 item scores, for a range of 0-264.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
1342457|NCT01913535|Secondary|Clinical Global Impression-Improvement (CGI-I)|The CGI-I scale was administered by clinicians to measure improvement in depressive severity (CGI-I). Each item is rated on a seven-point scale (1=very much improved to 7=very much worse), so a higher total score indicates less improvement in depressive severity. Improvement is assessed based on the last 24 hours.|72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
1342458|NCT01913535|Secondary|Change in Clinical Global Impression -Severity (CGI-S)|"The CGI-S scale was administered by clinicians to measure depressive severity (CGI-S). Each item is rated on a seven-point scale (1=normal to 7=among the most severe), so a higher total score indicates greater depressive severity. Severity is assessed based on the last 24 hours.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
1342459|NCT01913535|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|"The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity (in past 3 days), was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
1342703|NCT01910389|Secondary|Composite Outcome of All-cause Mortality or CV Hospitalization (Myocardial Infarction, Acute Coronary Syndrome, Stroke, Arrhythmia, or Heart Failure)||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
1342460|NCT01913535|Secondary|Number of Participants With Response on Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)|"Compare response rates at 72 hours for of patients treated with either dose (10 mg/day or 20 mg/day) of CERC-501 to those assigned to placebo therapy, using the Sequential Parallel Comparison Design (SPCD), with response defined as a 50% or greater reduction from baseline to Day 3 on the HAM-D-6 total score).~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.~The HAM-D-6 instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms."|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||Participants|||Count of Participants
1342461|NCT01913535|Secondary|Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6), Day 20|"This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 20 days after initiating treatment|The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms. 2 participants were in low dose drug-drug arm, 2 participants were in high dose drug-drug arm, and 1 participant was in the placebo-placebo arm. One drug-drug pt missing day 20 data.|||units on a scale||Full Range|Median
1342462|NCT01913535|Primary|Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)|"This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||units on a scale||Full Range|Median
1342463|NCT01913483|Secondary|Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30|"Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC.~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation."|Study drug initiation (Day 1) up to 30 days|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.|||participants|||Number
1342464|NCT01913483|Secondary|Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration|"Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3).~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation."|Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.|||participants|||Number
1342465|NCT01913483|Primary|Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)|"BARC ≥3 includes:~Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision.~Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period.~Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death."|Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.|||percentage of participants|||Number
1342553|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.|||participants|||Number
1342467|NCT01913470|Secondary|Changes in Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations Between Baseline and End of Treatment|PAI-1 is an acute-phase protein that is associated with both injury and inflammation, and has been found to be elevated in adolescents with significant hepatic steatosis. The reference range for PAI-1 in fasting adults is 3-72 ng/mL|Baseline, Week 8, Week 14, Week 22|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One additional participant is missing PAI-1 data from the placebo phase of the study.|||ng/mL||Standard Deviation|Mean
1342468|NCT01913470|Secondary|Changes in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) Between Baseline and End of Treatment (8 Weeks of Treatment)|Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) is an equation which indicates the degree of insulin resistance, where higher scores equate to greater insulin resistance. HOMA-IR is calculated as fasting glucose (mg/dl) × insulin (mU/L)/405. A HOMA-IR value >2.0 in prepubertal children and >2.6 in pubertal children, may be considered a warning sign for pediatricians to further investigate insulin resistance.|Baseline (Week 0 and 14), End of Treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. An additional participant is missing HOMA-IR data from the placebo phase of the study.|||units on a scale||Standard Deviation|Mean
1342469|NCT01913470|Secondary|Change in Fatty Acid Levels From Baseline to End of Treatment (8 Weeks of Treatment)|In human studies, losartan has been shown to decrease serum free fatty acids, thus any decrease in this measurement indicates a positive response to losartan.|Baseline (Week 0 and 14), End of Treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One participant is missing the endpoint measurement for free fatty acid levels, following the 8 week losartan treatment phase.|||mEq/L||Standard Deviation|Mean
1342470|NCT01913470|Secondary|Change in Triglyceride Levels From Baseline to End of Treatment (8 Weeks of Treatment)|For children aged 10 to 19, triglyceride levels of less than 90 is considered acceptable, 90 to 129 is borderline high, and greater than or equal to 130 and over is high.|Baseline (Week 0 and 14), End of treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One participant is missing data for the endpoint measurement of triglyceride levels, following 8 weeks of losartan treatment.|||mg/dL||Standard Deviation|Mean
1342471|NCT01913470|Secondary|Change in Cholesterol Levels From Baseline to End of Treatment (8 Weeks of Treatment)|For children, a cholesterol level of less than 170 is considered acceptable, 170-199 is borderline high, and 200 and over is high.|Baseline (Week 0 and 14), End of treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One additional participant in each treatment group is missing the end of treatment cholesterol level measurement.|||mg/dL||Standard Deviation|Mean
1342472|NCT01913470|Primary|Change in Alanine Aminotransferase (ALT) From Baseline to End of Treatment (8 Weeks of Treatment)|The principal objective of this blinded, placebo controlled, crossover pilot study is to evaluate whether 8 weeks of losartan in children with nonalcoholic steatohepatitis (NASH) will decrease inflammation as measured by ALT.|Baseline (Weeks 0 and 14), Endpoint (Weeks 8 and 22)|In this blinded, crossover treatment, study participants received losartan or a placebo for 8 weeks, then completed a 6 week washout period before crossing over to the other treatment for 8 weeks. The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment.|||U/L||Standard Deviation|Mean
1342473|NCT01913405|Secondary|Clinically Significant Changes in Routine Laboratory Parameters- Hematology and Chemistry|Changes in clinical chemistry and hematology parameters from a normal or abnormal not clinically significant (ncs) result at screening to an abnormal and clinically significant (cs) result at the end of study assessment (EOS) are listed. Changes did occur in the following laboratory parameters: Alanine Aminotransferase (ALT) (U/L), Hemoglobin (g/L), Hematocrit, Erythrocytes(TI/L), Eosinophils/Leucocytes.|Throughout the entire study period from screening to completion/termination (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The outcome measure data include surgical enrollments with results both at screening and at the end of the study for each assay.|||Surgeries|Surgeries||Count of Units
1342474|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Pulse Rate|Changes in the pulse rate (beats/minute) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||beats/minute|Surgeries|Inter-Quartile Range|Median
1342475|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Respiratory Rate|Changes in Respiratory rate were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||breaths/minute|Surgeries|Inter-Quartile Range|Median
1342476|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Systolic and Diastolic Blood Pressure (BP)|Changes in systolic and diastolic blood pressure (mmHg) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||mmHg|Surgeries|Inter-Quartile Range|Median
1342704|NCT01910389|Secondary|All-cause Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
1342477|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Body Temperature|Changes in body temperature were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||°Celsius|Surgeries|Inter-Quartile Range|Median
1342478|NCT01913405|Secondary|Other Investigational Product (IP) - Related Adverse Events||Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
1342479|NCT01913405|Secondary|Incidence of Severe Allergic Reactions (e.g. Anaphylaxis)||Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
1342480|NCT01913405|Secondary|Occurrence of Thrombotic Events||Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
1342481|NCT01913405|Secondary|Development of Treatment Emerging Anti-chinese Hamster Ovary (CHO) Antibodies|A 72-hour washout period is required prior to immunogenicity tests.|Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
1342482|NCT01913405|Secondary|Development of Treatment Emerging Binding Antibodies to Factor VIII (FVIII), Treatment Emergent Binding Antibodies to PEGylated Recombinant FVIII (BX855), and Treatment Emerging Binding Antibodies to Polyethylene Glycol (PEG)|A 72-hour washout period is required prior to immunogenicity tests.|Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
1342483|NCT01913405|Secondary|Development of Inhibitory Antibodies to Factor VIII (FVIII)|Immunogenicity assessment using FVIII inhibitor by Nijmegen method. A 72-hour washout period is required prior to immunogenicity tests.|Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
1342484|NCT01913405|Secondary|Pharmacokinetics (PK) - Incremental Recovery(IR)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Incremental recovery (IR) was calculated as C post infusion minus C pre-infusion divided by the dose.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.|For measurement at 15 min post-infusion only 23 surgeries in 18 participants were available for analysis.|||(IU/dL):(IU/kg)|Surgeries|Standard Deviation|Mean
1342485|NCT01913405|Secondary|Pharmacokinetics (PK) - Apparent Volume of Distribution at Steady State (Vss)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Apparent steady state volume of distribution (Vss) was calculated as dose multiplied with AUMC(0-inf) divided by AUC(0-inf) to square.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||dL/kg|Surgeries|Standard Deviation|Mean
1342486|NCT01913405|Secondary|Pharmacokinetics (PK) - Clearance (CL)|"Following a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Systemic clearance (CL) was calculated as the dose in IU/kg divided by the total AUC.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. h = hours"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||dL/(kg*h)|Surgeries|Standard Deviation|Mean
1342487|NCT01913405|Secondary|Pharmacokinetics (PK) - Mean Residence Time (MRT)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Mean residence time (MRT) was calculated as total area under the moment curve divided by the total area under the curve.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||Hours|Surgeries|Standard Deviation|Mean
1342705|NCT01910389|Secondary|Heart Failure Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
1342488|NCT01913405|Secondary|Pharmacokinetics (PK) - Terminal Half-life (T1/2)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Terminal or disposition half-life (HL) was calculated as log e(2)/λz where the terminal or disposition rate constant (λz) was estimated as the slope of a log-linear least squares regression model.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||Hours|Surgeries|Standard Deviation|Mean
1342489|NCT01913405|Secondary|Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours Post-infusion (AUC0-96h)|"Following at least a 72 hour (h) washout period a single dose of BAX855 will be administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period.~The area under the plasma concentration/time curve from time 0 to 96 hours postinfusion (AUC 0-96h) was computed using the linear trapezoidal rule. For the calculation of AUC 0-96h the levels at 96 hours were linearly interpolated/extrapolated from the 2 nearest sampling time points.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||IU*h/dL|Surgeries|Standard Deviation|Mean
1342490|NCT01913405|Secondary|Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞)|"Following at least a 72 hour washout period a single dose of BAX855 was administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period.~The area under the plasma concentration/time curve from time 0 to infinity (AUC 0-inf) and the area under the first movement curve from time 0 to infinity (AUMC 0-inf) was calculated as the sum of AUC and AUMC from time 0 to the time of the last quantifiable concentration plus a tail area correction calculated as Ct/λz and Ct/λz(t+1/λz), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and λz is the terminal or disposition rate constant.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||IU*h/dL|Surgeries|Standard Deviation|Mean
1342491|NCT01913405|Secondary|Consumption of BAX855|Daily and total weight-adjusted consumption of BAX855 per subject.|From initial loading dose until discharge for daily weight-adjusted dose and from first infusion (PK/IR) until end of study for total weight-adjusted dose.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery. Number of surgeries/participants with BAX855 consumption varies on each postoperative day.|||IU/kg|Surgeries|Standard Deviation|Mean
1342492|NCT01913405|Secondary|Occurrence of Bleeding Episodes and Additional Need for Surgical Intervention|Any clinically relevant bleeding episodes (as assessed by the investigator) as well as the need for any further surgical interventions were recorded. If the subject had not resumed his previous treatment after discharge, the occurrence and treatment of bleeding episodes were recorded in the subject's diary.|Intra- and post-operative period, until the last intensified treatment after hospital discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks)|Only surgeries/participants that have encountered bleeding episodes are reported for the analysis of bleeding episodes (5 surgeries in 5 participants) and all surgeries/participants are reported for the analysis of the need for surgical intervention.|||Events|Surgeries||Number
1342493|NCT01913405|Secondary|Transfusion Requirements|Volume of blood, red blood cells, platelets, and other blood products transfused. Only packed red blood cells were transfused in this study.|From initiation of the surgery to 24 hours after completion of the surgery.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery. Only participants who received blood transfusions are included in this analysis.|||Milliliter|Surgeries|Standard Deviation|Mean
1342494|NCT01913405|Secondary|Overall Perioperative Blood Loss|Actual overall perioperative blood loss (assessed at the end of surgery, at postoperative day 1 and until discharge or day 14 - whichever is first) was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected perioperative blood loss was predicted pre-operatively by the investigator/surgeon.|From start of surgery until discharge or day 14, whichever occurred first.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.|||Milliliter|Surgeries|Inter-Quartile Range|Median
1342495|NCT01913405|Secondary|Postoperative Blood Loss|Actual post-operative blood loss assessed at postoperative day 1 was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected postoperative blood loss was predicted pre-operatively by the investigator/surgeon.|From completion of surgery until 24 hours after surgery.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.|||Milliliter|Surgeries|Inter-Quartile Range|Median
1342496|NCT01913405|Secondary|Intraoperative Blood Loss|Actual intraoperative blood loss was assessed at the end of surgery and was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected intraoperative blood loss was predicted preoperatively by the investigator/surgeon.|From initiation of surgery until end of surgery.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.|||Milliliter|Surgeries|Inter-Quartile Range|Median
1342509|NCT01912781|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.|||percentage of lens area||Standard Deviation|Mean
1342497|NCT01913405|Primary|Global Hemostatic Efficacy Assessment Score (GHEA) - Composed of 3 Individual Ratings|"GHEA=Sum of 1-3 ratings: Excellent: 7-9 (no category <2), Good: 5-7 (no category <1), Fair: 3-4 (no category <1)~1. Intraoperative and 2. Postoperative (postoperative day 1) hemostatic efficacy assessments: Excellent=3: Blood Loss (BL) ≤ than expected for procedure type in non-hemophilic population (NHP) (≤100%), Good=2: BL ≤50% more than expect. for procedure type in NHP (101-150%), Fair=1: BL >50% more than expect. for procedure type in NHP (>150%), None=0: Significant bleeding-requiring rescue therapy (RT) 3. Perioperative hemostatic efficacy assessment (day 14 or discharge, whatever is first): Excellent=3: BL and required blood transfusions (BT) less than or similar (≤100%) to that expected for procedure type in NHP, Good=2: BL ≤50% more (101-150%) and BT less than or similar to that expected for procedure type in NHP, Fair=1: BL >50% more (>150%) and BT greater than expected in NHP, None=0: Significant bleeding-requiring RT, BT substantially greater than expected in NHP"|Hemostatic efficacy assessments were performed intraoperatively, postoperatively on day 1 (approximately 24 hours after surgery) and perioperatively at day 14 or discharge (whichever was first).|Full analysis group comprises groups major orthopedic and non-orthopedic and minor surgery. Main analysis was done on the full analysis group (at least one hemostatic assessment available) and supportive analysis was done on the per protocol analysis group (all hemostatic assessments available).|||Percentage of surgeries|Surgeries|90% Confidence Interval|Number
1342498|NCT01913314|Secondary|Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma|The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = [AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity] * 100.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-∞) data.|||percentage of total plasma radioactivity|||Number
1342499|NCT01913314|Secondary|Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces|The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) * 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted.|Predose through 216 h postdose; Fecal samples collected at 24-h intervals|Participants who received study drug and had evaluable PK data. No participants were analyzed for relative abundance of LY2835219 and metabolites of LY2835219 in urine.|||percentage of radioactive dose excreted|||Number
1342500|NCT01913314|Secondary|Plasma PK of Radioactivity: AUC(0-∞)||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK data.|||ng Eq*h/g||Geometric Coefficient of Variation|Geometric Mean
1342501|NCT01913314|Secondary|Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)]||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-∞) data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1342502|NCT01913314|Secondary|Plasma PK of Radioactivity: AUC(0 to Tlast)|The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq*h/g).|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-tlast) data.|||ng Eq*h/g||Geometric Coefficient of Variation|Geometric Mean
1342503|NCT01913314|Secondary|Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)]||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-tlast) data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1342504|NCT01913314|Secondary|Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax)||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and evaluable PK tmax data.|||h||Full Range|Median
1342505|NCT01913314|Secondary|Plasma PK of Radioactivity: Cmax||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK Cmax data.|||nanogram equivalents per gram (ng Eq/g)||Geometric Coefficient of Variation|Geometric Mean
1342506|NCT01913314|Secondary|Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax)||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1342507|NCT01913314|Primary|Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered|The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) * 100.|Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose|Participants who received study drug.|||percentage radioactive dose administered||Standard Deviation|Mean
1342508|NCT01913041|Primary|The Incidence of Perioperative Hypothermia|Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature <36℃) accounts for the total amount of participants.|Perioperative period started from anesthesia induction to surgery ended|Actually 869 patients are enrolled, among which 39 patients were eliminated for the reasons operation cancelled temporarily or violate the eligible criteria, so 830 participants for analysis was determined to be analyzed per protocol in the end.|||Percentage of hypothermia participants|||Number
1342534|NCT01912599|Primary|Diastolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours||||mmHg||Standard Deviation|Mean
1342535|NCT01912599|Primary|Mean Perfusion Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours||||mmHg||Standard Deviation|Mean
1342510|NCT01912781|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.|||percentage of lens area||Standard Deviation|Mean
1342511|NCT01912781|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
1342512|NCT01912781|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
1342513|NCT01912781|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
1342514|NCT01912781|Primary|Number of Unscheduled Lens Replacements by Reason|No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.|||lenses|||Number
1342515|NCT01912781|Primary|Average Lens Wear Time|Subject recorded a response to the question, “Averaging over the last 3 days, how many hours per day did you wear your contact lenses?” Lens wear time was measured in hours.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||Hours||Standard Deviation|Mean
1342516|NCT01912781|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
1342517|NCT01912781|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 90/Early Exit|This analysis population includes all randomized subjects.|||micrograms per lens||Standard Deviation|Mean
1342518|NCT01912781|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.|||percentage of subjects|||Number
1342519|NCT01912781|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.|||percentage of subjects|||Number
1342520|NCT01912781|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
1342521|NCT01912768|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."|||percentage of lens area||Standard Deviation|Mean
1342536|NCT01912599|Primary|Intraocular Pressure|The IOP provided is the average of all 144 measurements taken during the 24 hour period.|24 Hours||||mEqv.||Standard Deviation|Mean
1342522|NCT01912768|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."|||percentage of lens area||Standard Deviation|Mean
1342523|NCT01912768|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
1342524|NCT01912768|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
1342525|NCT01912768|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
1342526|NCT01912768|Primary|Number of Unscheduled Lens Replacements by Reason|A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.|||lenses|||Number
1342527|NCT01912768|Primary|Average Lens Wear Time|"Subject recorded a response to the question, Averaging over the last 3 days, how many hours per day did you wear your contact lenses? Lens wear time was measured in hours."|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||Hours||Standard Deviation|Mean
1342528|NCT01912768|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
1342529|NCT01912768|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 30/Early Exit|This analysis population includes all subjects with data at visit.|||micrograms per lens||Standard Deviation|Mean
1342530|NCT01912768|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."|||percentage of subjects|||Number
1342531|NCT01912768|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."|||percentage of subjects|||Number
1342532|NCT01912768|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
1342533|NCT01912599|Primary|Systolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours||||mmHg||Standard Deviation|Mean
1342537|NCT01912599|Primary|Arterial Pressure|The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|"Data for two glaucoma patients were excluded for analysis because~In one patient the IOP recorder malfunctioned just two hours after set up, so data were not available for the entire 24 hours~In the other patient, the wireless sensor was disconnected from the recorder in the middle if the night so data could not be recorded."|||mmHg||Standard Deviation|Mean
1342538|NCT01912495|Secondary|Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.|only serious adverse events are recorded in this secondary endpoint|72 weeks|57 patients started treatment and were at risk|||participants|||Number
1342539|NCT01912495|Secondary|Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.||72 weeks|data were not collected during this study||||||
1342540|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.|The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.|12 weeks|5 patients were treated within 12 weeks after calculated transmission date. All other patients were treated between 12 and 26 weeks after calculated transmission date.|||participants|||Number
1342541|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.|The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment|12 weeks|All patients having a rapid viral response at week 4 had a sustained viral response at 12(SVR12) weeks after treatment.|||participants|||Number
1342542|NCT01912495|Secondary|SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).|The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy|12 weeks|Total intention to treat population|||participants|||Number
1342543|NCT01912495|Primary|Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population.|The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.|12 weeks|41 patients had a RVR4|||participants|||Number
1342544|NCT01912404|Primary|Survival||28 days|The study was prematurely stopped due to emerging data from another study showing ~10 to 12-fold higher exposures in patients with severe hepatic impairment compared to those with normal liver function. Since subjects with alcoholic hepatitis would likely have severe hepatic impairment, the study was stopped and survival data was not collected.||||||
1342545|NCT01912352|Secondary|Clinical Global Impression-Improvement Scale at 8 Weeks|"Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: “Compared to the patient's condition at baseline [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.~Clinical Global Impression-Improvement was measured at 8 weeks."|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1342546|NCT01912352|Primary|Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks|"Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms).~Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks."|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1342547|NCT01912339|Secondary|Responders at 12 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 12 months compared to baseline.|12 Months|Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.|||Participants|||Number
1342548|NCT01912339|Secondary|Responders at 6 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 6 months compared to baseline.|6 Months|Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.|||Participants|||Number
1342549|NCT01912339|Secondary|Responders at 3 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 3 months compared to baseline.|3 Months|Intention to Treat population (ITT)|||Participants|||Number
1342550|NCT01912339|Primary|Safety: Device Related Serious Complications|"This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months.~Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint."|3 Months|Intention to Treat population (ITT) for treatment arm subjects only. Control subjects did not undergo a treatment procedure so they were not assessed for this endpoint.|||Participants||95% Confidence Interval|Number
1342551|NCT01912339|Primary|Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up|Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms).|3 Month Follow-up Visit|Intention to Treat population (ITT)|||Cange in IPSS score||95% Confidence Interval|Mean
1342552|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.|||participants|||Number
1342554|NCT01912222|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.|||participants|||Number
1342555|NCT01912222|Primary|Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.|||hours||Full Range|Median
1342556|NCT01912222|Primary|Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1342557|NCT01912222|Primary|Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.|||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1342558|NCT01911845|Secondary|Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||ng/mL||Standard Deviation|Mean
1342559|NCT01911845|Secondary|Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||hours||Standard Deviation|Mean
1342560|NCT01911845|Secondary|Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||ng/mL||Standard Deviation|Mean
1342561|NCT01911845|Secondary|Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng*hr/mL)] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||ng*hr/mL||Standard Deviation|Mean
1342562|NCT01911845|Secondary|Percentage of Participants With Virologic Relapse Post-treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days.|From the end of treatment through 12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||Percentage of participants|||Number
1342579|NCT01911780|Secondary|The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.|The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|Double-blind and 8 weeks|FAS|||Participants||95% Confidence Interval|Number
1342563|NCT01911845|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks [≥ 36 days] of treatment.|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All enrolled participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1342564|NCT01911845|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All enrolled participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1342565|NCT01911819|Secondary|The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.|Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.|24months||||percentage of residual bone materials|Maxillary Sinuses|Standard Deviation|Mean
1342566|NCT01911819|Primary|The Percentage of Vital Bone in a Total Amount of a Bone Specimen|Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.|24months||||percentage of vital bone|Maxillary sinuses|Standard Deviation|Mean
1342567|NCT01911793|Secondary|Diagnosis of Postoperative Ileus|diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342568|NCT01911793|Secondary|Episodes of Vomiting|any episodes of vomiting will be recorded|during postoperative hospital admission (30 day period)|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342569|NCT01911793|Secondary|Any Insertion of Nasogastric Tube|insertion of nasogastric tube after surgery will be recorded|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342570|NCT01911793|Secondary|Major and Minor Medical and Surgical Complications|any major or minor medical and surgical complications after surgery will be recorded|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342571|NCT01911793|Secondary|Time to Discharge Based on GI Function|postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342572|NCT01911793|Secondary|Hospital Discharge|postoperative day after surgery which patient was discharged home|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342573|NCT01911793|Secondary|Time to Passage of Stool|# of hours after surgery until the patient passes stool into stoma bag|during 30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342574|NCT01911793|Secondary|Time to Flatus (Passing Gas Into Stoma Bag)|# of hours after surgery at which point first passage of flatus (gas) into stoma bag|during 30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342575|NCT01911793|Primary|Tolerating Low Residue Diet|% of patients tolerating a low residue diet on postoperative day 3 will be assessed|by postoperative day 3( 3rd day after surgery)|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
1342576|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FASEX (OC)|||mmHg||Standard Error|Mean
1342577|NCT01911780|Secondary|Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS in the extension period (FASEX OC) was defined as a collection of patients i) included in the FAS; ii) taking at least 1 dose of T80/A5/H12.5 mg in the extension period; and iii) taking measurements of seated DBP at reference baseline and at 1 or more time points in the extension period.|||mmHg||Standard Error|Mean
1342578|NCT01911780|Secondary|The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.|"The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS|||Participants|||Number
1342706|NCT01910389|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
1342580|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|FAS|||mmHg||Standard Error|Mean
1342581|NCT01911780|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|Full analysis set (FAS) was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period|||mmHg||Standard Error|Mean
1342582|NCT01911689|Secondary|The Relationship Between the T2* Value and the Severity of AP According to Apache II|In clinical practice, the physician usually used the APACHE II to evaluate the severity of acute pancreatitis. AP was graded as mild (0-7 points) and severe AP (≥8 points) according to the APACHE II scoring system.|1 year|Indengpent T test|||ms||Standard Deviation|Mean
1342583|NCT01911689|Secondary|The T2* Value in Different Severity of AP According to MRSI|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .|1 year|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .|||ms||Standard Deviation|Mean
1342584|NCT01911689|Secondary|The Difference of T2* Value Between the Edematous AP and Necrotizing AP|Compare the difference of the T2* value between the edematous AP group and necrotizing AP group|1 year|compare the difference of T2* value between the edematous AP and necrotizing AP|||ms||Standard Deviation|Mean
1342585|NCT01911689|Primary|The T2* Values in the Diagnosis of AP|Compare the difference of the T2* value between the AP group and the control group.|1 year|compare T2* value between the AP group and the control group using independent sample t test|||ms||Standard Deviation|Mean
1342586|NCT01911546|Secondary|Incidence of Cell Mediated Rejection (CMR)|Patients will be monitored for any episodes of CMR.|6 months||||Participants|||Count of Participants
1342587|NCT01911546|Primary|Incidence of Antibody Mediated Rejection (ABMR)|Protocol biopsies were obtained at T0 and 6 months post transplant.|6 months||||Participants|||Count of Participants
1342588|NCT01911546|Primary|The Number of CMV Viremia|The number of patients with CMV viremia|12 Months||||Participants|||Count of Participants
1342589|NCT01911546|Primary|The Number of Polyoma BK Viremia Patients|Patients will be monitored at regular interval for the development of Polyomavirus Viremia.|12 months||||Participants|||Count of Participants
1342590|NCT01911442|Secondary|Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.||6 Weeks|ITT|||percentage of subjects|||Number
1342591|NCT01911442|Secondary|Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6||6 Weeks|ITT - the current data presented is at week 6.|||percentage of subjects|||Number
1342592|NCT01911442|Secondary|Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)|CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain.|6 Weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
1342593|NCT01911442|Secondary|Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)|CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score.|6 Weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
1342594|NCT01911442|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6|The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
1342595|NCT01911442|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6|The Clinical Global Impression – Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat population. 49 in the placebo arm is correct. One subject in the placebo group did not receive the study medication, and therefore that subject was removed from the ITT population. A total of 50 subjects were randomized and 49 subjects were included in the placebo group of the ITT population.|||units on a scale||Standard Error|Least Squares Mean
1342596|NCT01911442|Primary|Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6|The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat (ITT) population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.|||units on a scale||Standard Error|Least Squares Mean
1342707|NCT01910389|Primary|Composite Outcome of Cardiovascular (CV) Mortality or Heart Failure (HF) Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
1342597|NCT01911429|Secondary|Change From Baseline in PANSS Excitability Subscale Scores|"Excitability subscale scores (range 4-28): consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control~Higher values of PANSS Excitability Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
1342598|NCT01911429|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Scores|"PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures -– General psychopathology (range 16-112): sum of Items G1 to G16 in the general psychopathology subscale -Higher values of PANSS General Psychopathology Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
1342599|NCT01911429|Secondary|Change From Baseline in Clinician-rated Children’s Global Assessment Scale (CGAS)|"Clinician-rated Children’s Global Assessment Scale (CGAS) score: summary statistics over time - CGAS is a numeric scale (1 through 100) , where 1 represents the most impaired functioning and 100, superior functioning~LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
1342600|NCT01911429|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)|"PQ-LES-Q percentage maximum possible score: summary statistics over time - PQ-LES-Q % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.~LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
1342601|NCT01911429|Secondary|Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6|PANSS responder analysis over time: achieving >= 20% reduction from baseline|week 6|ITT Population|||number of participants|||Number
1342602|NCT01911429|Secondary|Change From Baseline in PANSS Positive, Negative Subscale Scores|"PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures - – Negative subscale (range 7-49): sum of Items N1 to N7 in the negative subscale - Higher values of PANSS Negative Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
1342603|NCT01911429|Secondary|Change From Baseline in PANSS Positive Subscale Scores|"PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures –Positive subscale (range 7-49): sum of Items P1 to P7 in the positive subscale - Higher values of PANSS Positive Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
1342604|NCT01911429|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale|"Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures- scale from 1-7 - 1=normal, not at all ill; 7=among the most extremely ill patients.~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction."|baseline, week 6|The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Mean
1342605|NCT01911429|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.|"PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction."|Baseline to 6 weeks|The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.|||units on a scale||Standard Deviation|Mean
1342606|NCT01911403|Secondary|Percentage of Patients With Angio-Seal™ Deployment Success|"According the physician criteria, it will be YES If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture."|At puncture closure|Only patients in the Angio-Seal arm is analyzed|||percentage of patients|||Number
1342607|NCT01911403|Secondary|Time to Discharge From Interventional Radiology Department|Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.|At discharge||||hours||Standard Deviation|Mean
1342608|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 4-60 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure||||participants|||Number
1342609|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 0-4 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure||||participants|||Number
1342610|NCT01911403|Secondary|Number of Patients With Any Complications|"Number of patients with any complications since the puncture closure until 2 weeks ± 1 week.~The complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion."|At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)||||participants|||Number
1342611|NCT01911403|Secondary|Number of Patients With Mobilization Time Between 4-48 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge||||participants|||Number
1342612|NCT01911403|Primary|Number of Patients With Mobilization Time Between 0-4 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge||||participants|||Number
1342613|NCT01911390|Secondary|Palatability|Other outcomes include palatability and acceptability of study-provided snacks that include cooked navy bean powder, rice bran, or a combination in children. The participants will fill out questionaires describing how the products tasted and how much they consumed.|Baseline, 4 weeks|The criteria used to quantify GI discomforts or issues included participants who responded ‘yes’ to any GI discomfort and rated the discomfort level ≥3 out of a 5-point scale.|||Participants|||Count of Participants
1342614|NCT01911390|Primary|Total Cholesterol|The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.|Baseline, 4 weeks||||mg/dL||Standard Deviation|Mean
1342615|NCT01911351|Other Pre-specified|Percentage of Providers Who Rated the Procedure as Being Successful|Survey collection of rating of success of the procedure by one provider. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. The first two categories were combined.|measured at the end of each procedure, approximately 10 minutes after the completion of the procedure||||percentage of participants|||Number
1342616|NCT01911351|Other Pre-specified|Percentage of Parents Who Reported That Their Child Was Comfortable During the Procedure|"A parental survey was collected post-procedure regarding the overall comfort of the child during the procedure. Other questions included whether the procedure was successfully completed, if the procedure went better than expected, was the parent pleased with the medications used and whether the child tolerated the procedure. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. We chose the question that asked whether the child was comfortable during the procedure as it was most relevant. The categories Strongly Agree and Agree were combined in both groups."|measured at the end of each procedure, approximately 10 minutes after the procedure is completed|In the Standard Management arm, 38/39 parents completed the survey|||percentage of participants|||Number
1342617|NCT01911351|Other Pre-specified|Length of the Procedure|Another outcome measure is to compare the change in length of the procedure with or without nitrous oxide intervention.|measure time duration of each procedure, average 5-15 minutes||||minutes||Inter-Quartile Range|Median
1342618|NCT01911351|Secondary|M-YPAS Anxiety Scale|Secondary outcome will be the Modified YALE Preoperative Anxiety Scale, measured pre-procedure, and intra-procedure. This is a validated scale measuring anxiety by assessment of Activity, Vocalization, Emotional Expressivity, State of Arousal and Use of Parents. All categories have a maximum score of 4 except for Vocalization with a maximum score of 6. The scores within each category are totaled and a total anxiety score is reported ranging from 5 (no anxiety) to 22 (highest level of anxiety).|measured pre-procedure at time provider explains procedure to the patient, and during procedure at peak pain time approximately 2-5 minutes into the procedure||||units on a scale||Inter-Quartile Range|Median
1342619|NCT01911351|Primary|FLACC Pain Scale|The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.|peak pain during procedure approximately 2-5 minutes into the procedure||||units on a scale||Inter-Quartile Range|Median
1342620|NCT01911273|Secondary|Observed Serum Concentration of Circulating Protein||Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.|||mcg/mL|||Number
1342621|NCT01911273|Secondary|Ratio to Baseline of Serum Circulating Protein Concentration|Protein involved TGFB1, VEGF-A, VEGF-C, PIGF, Endoglin, BMP-9, VEGFR1, VEGFR2, VEGFr3, Ang-2, VEGF-D, CD54, CD106, and CCL2. Tumor molecular characteristics including but not limited to transcriptomic (ribonucleic acid) signatures of efficacy.|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Percentage|||Number
1342622|NCT01911273|Secondary|Presence of Sensitivity Signature|Tumor molecular characteristics including but not limited to transcriptomic (RNA) signatures of sensitivity|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.||||||
1342623|NCT01911273|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)||Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose)|The immunogenicity assessment consisted of all participants who had at least 1 sample on at least 1 day of immunogenicity assessment.|||Participants|||Number
1342624|NCT01911273|Secondary|Trough Serum Concentration of PF-03446962 (Ctrough)||0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8|The PK concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.|||mcg/mL||Standard Error|Geometric Mean
1342625|NCT01911273|Secondary|Maximum Serum Concentration (Cmax)||1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8|The pharmacokinetic (PK) concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.|||microgram per milliliter (mcg/mL)||Standard Error|Geometric Mean
1342647|NCT01911065|Other Pre-specified|Identify Predictors That Correlate With a Rapid and Diverse T Cell Response.|The investigators will use the frequency and TCR diversity of VZV-specific T cells on days 7 and 14 after vaccination as outcome variable and identify predictors that positively or negatively correlate with a rapid and diverse T cell response in the different age groups.|0 to 14 Days|||||||
1342626|NCT01911273|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep)|Patient reported outcomes (PROs) were assessed using the FACT-Hep. The FACT-Hep included the FACT-general (FACT-G) and a hepatobiliary module, it consisted of the 27-item FACT-G, which assessed generic health-related quality of life (HRQoL) concerns, and the 18-item hepatobiliary subscale (HS), which assessed disease-specific issues. The questionnaire used a 5 point Likert scale from ‘0’ “not at all” to ‘4’ “very much” regarding how much each item was present in the last 7 days; lower score indicated severer symptom. Eight of the items (lack of energy, pain, weight loss, back pain, fatigue, stomach pain/discomfort, nausea, and jaundice) made up the Fact Hepatobiliary Symptom Index (FHSI 8) were considered to be symptoms specific to hepatobiliary cancer.|Screening, Cycle 1 Day1,8; Cycle >=2 Day1; End of treatment, survival follow-up up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Units on scale||Standard Deviation|Mean
1342627|NCT01911273|Secondary|Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks|DCR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease (SD) >=16 weeks according to RECIST, relative to all randomized participants. CR was defined as disappearance of all target lesions. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|FAS included all randomized participants regardless of what treatment, if any, was received.|||Percentage of Participants||95% Confidence Interval|Number
1342628|NCT01911273|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included >1 date, the first date was to be used. DR (in months) was calculated as the end date for DR minus date of first CR or PR that was subsequently confirmed plus 1 divided by 30.4. CR was defined as disappearance of all target lesions and non-target, if any. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Subgroup of participants with objective response. Since objective response was not assessed in any of the participants, ideally the number of participants analyzed field should be 0 and the reason was insufficient data available to conduct adequate analysis due to premature termination of the study.||||||
1342629|NCT01911273|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1, relative to all randomized participants. CR were those that persisted on repeat imaging study more than or equal to (>=) 4 weeks after initial documentation of response. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were to be counted as non-responders in the assessment of ORR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR, was to be assigned a best response of CR.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Percentage of Participants|||Number
1342630|NCT01911273|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included >1 date, the first date was to be used. PFS (in months) was calculated as first event date minus first randomization date plus 1 divided by 30.4.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1342631|NCT01911273|Primary|Overall Survival (OS)|OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death.|From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Full analysis set (FAS) included all randomized participants regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1342632|NCT01911273|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from first randomization to date of first documentation of objective tumor progression. If tumor progression data included more than (>) 1 date, the first date was to be used. TTP (in months) was calculated as first event date or last known progression-free date minus the first randomization date plus 1 divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1342646|NCT01911169|Primary|Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D|Measures were be performed with a Phillips iU22 Ultrasound system and a L9-3 9 mHz probe in 2D mode by a single operator using EKG gating. Baseline measures of brachial artery diameter will be made after the 10 minutes of rest. The blood pressure cuff, placed on the ipsilateral forearm, was inflated to 50 mmHg above the patient's systolic blood pressure for five minutes and then released. Endothelium-dependent FMD was measured continuously during and for three minutes after cuff release. Subjects rested for 10 minutes. Then, endothelium-independent dilation was measured 3 minutes after administration of 0.4 mg of sublingual nitroglycerine. The outcome (%FMD) was the difference between the average endothelium dependent diameter after cuff deflation and the average baseline diameter. The absolute difference between the % FMD at baseline and 16 week follow up was reported.|from zero to sixteen weeks||||Absolute change in % FMD||Standard Deviation|Mean
1342633|NCT01911260|Primary|Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period.|"Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ < -1,5 Z-score), and Normal Height (HAZ between -1,0 and ±1,0 Z-score), and were randomly assigned to compose two exposed groups to receive a supplement of 30mg of zinc amino acid chelate, and two control groups to receive placebo individually once a week, during 12 weeks. Children's heights were measured at the End of Supplementation period and again after 12 weeks (Follow-up period). In combination with sex and age we transformed stature to Height-for-Age, expressed in Z-score, which was calculated as a number of standard deviations or Z-scores below or above the reference mean or median value, according to the formula below:~Z-score = (observed value - median value of the reference population) / standard deviation value of reference population.~We analyzed and discussed the change in HAZ (HAZ at the End of Follow-up period - HAZ at End of Supplementation)."|Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.||||Z-Score||Standard Deviation|Mean
1342634|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.|||Number of subjects|||Number
1342635|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.|||Number of subjects|||Number
1342636|NCT01911221|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)|The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported.|Day 1 through Day 7 postvaccination.|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
1342637|NCT01911221|Primary|Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.|||Percentage of Subjects||95% Confidence Interval|Number
1342638|NCT01911221|Primary|Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
1342639|NCT01911221|Primary|Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule|The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination.|Day 1 and Day 91|Analysis was done on Full Analysis Set.|||U/mL||95% Confidence Interval|Geometric Mean
1342640|NCT01911221|Primary|Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day 91|Analysis was done on Full Analysis Set.|||Percentage of subjects||95% Confidence Interval|Number
1342641|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.|||Percentage of Subjects||95% Confidence Interval|Number
1342642|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.|||Percentages of subjects||95% Confidence Interval|Number
1342643|NCT01911221|Primary|Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.|Day1 and Day 91|The analysis was done on the Full Analysis Set.|||ratio||95% Confidence Interval|Geometric Mean
1342644|NCT01911221|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.|Day1 and Day 91|Analysis was done on Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
1342645|NCT01911169|Secondary|Change in Interferon Signature|This outcome was not measured as planned|from zero to sixteen weeks|||||||
1342648|NCT01911065|Secondary|Number of Participants With Related Adverse Events||0 to 35 Days||||Participants|||Count of Participants
1342650|NCT01910831|Secondary|Investigator Global Assessment (IGA)|"To determine efficacy with respect to the IGA of improving the appearance of “bruising” and reducing the appearance of photoaging of the forearms and hands:~IGA:~0=No improvement~<25% improvement~25% to 50% improvement~51% to 75% improvement~>75% improvement"|12 Weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.|||units on a scale||Standard Deviation|Mean
1342651|NCT01910831|Primary|Reduction of Bruising|To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in improving the appearance of bruising and reducing the appearance of photoaging of the forearms and hands in mature skin.|12 weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.|||cm squared||Standard Deviation|Mean
1342652|NCT01910792|Primary|# of Pts w/ Enhanced Vitamin D Status|Increase circulating 25(OH)D levels|Baseline, Months 1, 2, 3|Only 3 subjects in each Arm had a conclusive set of data eligible for analysis.|||Participants|||Count of Participants
1342653|NCT01910688|Secondary|Adverse Events|Adverse event profile: Relationship to study device : Definite, Probable, Possible|12 months||||number of events|||Number
1342654|NCT01910688|Secondary|Patient Tolerability|Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.|12 months||||number of events|||Number
1342655|NCT01910688|Secondary|Technical Feasibility: Percentage of Participants Who Completed RFA Treatment|Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.|Day 0, month 4, month 8|At 0 month, 25 received 1st RFA treatment; at 4 month, 22 received 2nd RFA treatment; at 8 month, 18 received RFA Treatment|||percentage of participants|||Number
1342656|NCT01910688|Primary|Excess Body Weight Loss After RFA Treatment|EBWL 12 months after enrollment|12 months||||percentage of EBWL||Standard Deviation|Mean
1342657|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1342658|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.|Up to 12 weeks|Full Analysis Set|||percentage of participants|||Number
1342659|NCT01910636|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1342660|NCT01910636|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1342661|NCT01910636|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, and had chronic genotype 2 HCV infection.|||percentage of participants|||Number
1342662|NCT01910441|Primary|Mean Amplitude of Glycemic Excursions (MAGE)||16 weeks|The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed.||||||
1342663|NCT01910402|Secondary|Number of Participants With Treatment Emergent Resistances|Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.|Up to week 48|On-treatment Genotypic Resistance Population|||Participants|||Number
1342664|NCT01910402|Secondary|Number of Participants With Post-Baseline HIV-1 Disease Progression|Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Up to week 48|ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.|||Participants|||Number
1342665|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups|Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Week 48|ITT-E Population|||Percentage of participants|||Number
1342666|NCT01910402|Secondary|Assessment of HIVTSQs Total Score at Indicated Timepoints.|The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Week 4, 12, 24, 48|ITT-E Population|||Score on a scale||Standard Deviation|Mean
1342667|NCT01910402|Secondary|Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS|The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline and Week 48|ITT-E Population|||Score on a scale||Standard Deviation|Mean
1342668|NCT01910402|Secondary|Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.|Baseline, Weeks 24, 48|Safety Population.|||Ratio||95% Confidence Interval|Number
1342669|NCT01910402|Secondary|Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Weeks 24, 48|Safety Population|||Nanomoles per liter||Standard Deviation|Mean
1342670|NCT01910402|Secondary|Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population|||Nanograms per liter||Standard Deviation|Mean
1342671|NCT01910402|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population|||Micrograms per liter||Standard Deviation|Mean
1342672|NCT01910402|Secondary|Number of Participants Who Withdrew From Treatment Due to AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
1342673|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Hematology Toxicities|Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
1342674|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Chemistry Toxicities|Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
1342675|NCT01910402|Secondary|Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.|From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)|Safety Population|||Participants|||Number
1342676|NCT01910402|Secondary|Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table.|Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
1342677|NCT01910402|Secondary|Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points|Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline, Week 24, Week 48|Safety Population|||milligrams per millimole||Standard Deviation|Mean
1342678|NCT01910402|Secondary|Change From Baseline in TC/HDL Ratio at Week 48|Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.|||Ratio||Standard Error|Least Squares Mean
1342679|NCT01910402|Secondary|Change From Baseline in Triglycerides at Week 48|Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.|||Millimoles per liter||Standard Error|Least Squares Mean
1342680|NCT01910402|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Femtoliter||Standard Deviation|Mean
1342681|NCT01910402|Secondary|Change From Baseline in Hematocrit Count at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Fraction of 1||Standard Deviation|Mean
1342682|NCT01910402|Secondary|Change From Baseline in Erythrocytes at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||10^12 per liter||Standard Deviation|Mean
1342683|NCT01910402|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||10^9 cells per liter||Standard Deviation|Mean
1342684|NCT01910402|Secondary|Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Ratio||Standard Deviation|Mean
1342685|NCT01910402|Secondary|Change From Baseline in Lipase at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Units per liter||Standard Deviation|Mean
1342686|NCT01910402|Secondary|Change From Baseline in Creatinine Clearance at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Milliliter per minute||Standard Deviation|Mean
1342687|NCT01910402|Secondary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||International units per liter||Standard Deviation|Mean
1342688|NCT01910402|Secondary|Change From Baseline in Albumin at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Grams per liter||Standard Deviation|Mean
1342689|NCT01910402|Secondary|Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Micromoles per liter||Standard Deviation|Mean
1342690|NCT01910402|Secondary|Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|"Safety Population. A value of 99999 indicates where no data is available or not able to determine the value."|||Millimoles per liter||Standard Deviation|Mean
1342691|NCT01910402|Secondary|Change From Baseline in CD4+ Cell Count at Indicated Timepoints|Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population|||Cells per millimeter cube||Standard Deviation|Mean
1342692|NCT01910402|Secondary|Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points|Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population|||Log10 copies/mL||Standard Deviation|Mean
1342693|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time|Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value.|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population|||Percentage of participants|||Number
1342694|NCT01910402|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48|Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication.|Week 48|ITT-E Population|||Percentage of participants|||Number
1342695|NCT01910389|Secondary|Trend in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
1342696|NCT01910389|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
1342697|NCT01910389|Secondary|Trend in 6 Minute Walk Distance From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
1342708|NCT01910311|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and who had evaluable PK data.|||hours (h)||Full Range|Median
1342709|NCT01910311|Primary|PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1342710|NCT01910311|Primary|PK: Maximum Concentration (Cmax) of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1342711|NCT01910181|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||months||95% Confidence Interval|Median
1342712|NCT01910181|Secondary|Percentage of Participants Who Died|The percentage of participants who died during the study was reported.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||percentage of participants|||Number
1342713|NCT01910181|Secondary|Progression-Free Survival (PFS)|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). PFS was defined as the time from treatment start to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||months||95% Confidence Interval|Median
1342714|NCT01910181|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants with death or disease progression during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||percentage of participants|||Number
1342715|NCT01910181|Secondary|Duration of Response According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). Duration of response was defined as the time from initial response of CR or PR to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% confidence interval (CI) was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.|||months||95% Confidence Interval|Median
1342716|NCT01910181|Secondary|Percentage of Participants With Disease Progression or Death Among Participants With a Previous Assessment of CR or PR According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants who died or progressed after CR or PR was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.|||percentage of participants|||Number
1342717|NCT01910181|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease from Baseline in sum diameter of target lesions. The percentage of participants with a best overall response of CR or PR during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1342718|NCT01910181|Primary|Terminal Elimination Rate Constant (Kel) of RO5185426 on Day 21|Plasma PK samples were obtained from each participant and the kel was estimated. The value was averaged among all participants and expressed in inverse hours (h^-1).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||hours^-1||Standard Deviation|Mean
1342735|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 8 weeks||||participants|||Number
1342719|NCT01910181|Primary|Accumulation Ratio of RO5185426 AUC From 0 to 8 Hours Between Day 21 and Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The AUC on Day 21 was divided by the AUC for Day 1. The resulting value was averaged among all participants and expressed as the accumulation ratio.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Days 1 and 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||accumulation ratio||Standard Deviation|Mean
1342720|NCT01910181|Primary|Ctrough of RO5185426 on Day 21|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
1342721|NCT01910181|Primary|Ctrough of RO5185426 on Day 19|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 19|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
1342722|NCT01910181|Primary|Trough Plasma Concentration (Ctrough) of RO5185426 on Day 15|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 15|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
1342723|NCT01910181|Primary|Elimination Half-Life (t1/2) of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of t1/2, defined as the time elapsed for plasma concentrations to drop by half. The value was averaged among all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||hours||Standard Deviation|Mean
1342724|NCT01910181|Primary|AUC From 0 to 168 Hours of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 168 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
1342725|NCT01910181|Primary|Tmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||hours||Full Range|Median
1342726|NCT01910181|Primary|Time of Maximum Plasma Concentration (Tmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.|||hours||Full Range|Median
1342727|NCT01910181|Primary|Cmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
1342728|NCT01910181|Primary|Maximum Plasma Concentration (Cmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.|||μg/mL||Standard Deviation|Mean
1342729|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
1342730|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
1342731|NCT01910181|Primary|AUC of RO5185426 From 0 to 8 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
1342732|NCT01910181|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 From 0 to 8 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in hours by micrograms per milliliter (h*μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 1|PK Population: All participants who provided evaluable data for PK analysis and did not have a significant protocol violation/deviation.|||h*μg/mL||Standard Deviation|Mean
1342733|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baselie and 16 weeks||||participants|||Number
1342734|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 12 weeks||||participants|||Number
1342736|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 4 weeks||||participants|||Number
1342737|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|12 weeks and 16 weeks||||participants|||Number
1342738|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|8 weeks and 12 weeks||||participants|||Number
1342739|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|4 weeks and 8 weeks||||participants|||Number
1342740|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|Baseline 4 weeks||||participants|||Number
1342741|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||Joints||Inter-Quartile Range|Median
1342742|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||Joints||Inter-Quartile Range|Median
1342743|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||Joints||Inter-Quartile Range|Median
1342744|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||Joints||Inter-Quartile Range|Median
1342745|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||joints||Inter-Quartile Range|Median
1342746|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||joints||Inter-Quartile Range|Median
1342747|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||Joints||Inter-Quartile Range|Median
1342748|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||joints||Inter-Quartile Range|Median
1342749|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
1342750|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
1342751|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
1342752|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1342753|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
1342754|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
1342755|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
1342756|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1342757|NCT01910116|Secondary|AUSCAN Function Change at 16 Weeks From Baseline|"Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
1342758|NCT01910116|Secondary|AUSCAN Function Change at 12 Weeks From Baseline|"Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
1342759|NCT01910116|Secondary|AUSCAN Function Change at 8 Weeks From Baseline|"Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
1342760|NCT01910116|Secondary|AUSCAN Function Change at 4 Weeks From Baseline|"Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Basline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1342761|NCT01910116|Secondary|AUSCAN Stiffness at 16 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 16 weeks||||units on a scale||Inter-Quartile Range|Median
1342762|NCT01910116|Secondary|AUSCAN Stiffness at 12 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Basline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
1342763|NCT01910116|Secondary|AUSCAN Stiffness at 8 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
1342764|NCT01910116|Secondary|AUSCAN Stiffness at 4 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1342765|NCT01910116|Secondary|AUSCAN Pain Score at 16 Weeks From Baseline|"Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
1342766|NCT01910116|Secondary|AUSCAN Pain Score at 12 Weeks From Baseline|"Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 12 weeks||||units on a scale||Inter-Quartile Range|Median
1342767|NCT01910116|Secondary|AUSCAN Pain Score at 8 Weeks From Baseline|"Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 8 weeks||||units on a scale||Inter-Quartile Range|Median
1342768|NCT01910116|Primary|AUSCAN Pain Change at 4 Weeks From Baseline|"Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100).~AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1342769|NCT01910064|Secondary|Percent Changes From Baseline in Total Lesion Counts||Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12||||percent change||Full Range|Median
1342770|NCT01910064|Primary|Local Tolerability (Stinging/Burning)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months||||subjects|||Number
1342771|NCT01910064|Primary|Local Tolerability (Pruritus)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months||||participants|||Number
1342772|NCT01910064|Primary|Local Tolerability (Dryness)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months||||participants|||Number
1342773|NCT01910064|Primary|Local Tolerability (Scaling)|Highest severity of Local tolerability scores worth than base line|12 months||||participants|||Number
1342774|NCT01910064|Primary|Local Tolerability (Erythema)|Highest severity of Local tolerability scores worth than base line|12 monhths||||participants|||Number
1342775|NCT01909804|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1342776|NCT01909804|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1342778|NCT01909804|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1342779|NCT01909778|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from intake of the second dose Faldaprevir up to 9 days|Only one patient was treated and completed this study; he was the only patient analyzed.|||participants|||Number
1342780|NCT01909778|Secondary|Assessment of Tolerability by Investigator|The investigator has assessed tolerability based on adverse events and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 1=“good”, 2=“satisfactory”, 3=“not satisfactory”, and 4=“bad”.|Day 6 of period 1 and 2|Only one patient was treated and completed this study; he was the only patient analysed.|||units on a scale|||Number
1342781|NCT01909778|Secondary|MRTpo|Mean residence time of the analyte in the body after oral administration (MRTpo).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||hours||Standard Deviation|Mean
1342782|NCT01909778|Secondary|Vz/F|Apparent volume of distribution during the terminal phase (Vz/F) following an extravascular dose (at steady state).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||Liter|||Number
1342783|NCT01909778|Secondary|CL/F|"Apparent clearance of the analyte in plasma following extravascular administration (CL/F).~The apparent clearance after oral administration will be determined according to the following equation: CL or CL/F=dose/AUC0-∞. (F=absolute bioavailability factor)"|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||mL/min|||Number
1342784|NCT01909778|Secondary|t1/2|Elimination half-life (t1/2). The terminal half-life will be calculated from the terminal rate constant.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||hours|||Number
1342785|NCT01909778|Secondary|AUC0-tz|Area under the concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUC0-tz).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||h*ng/mL|||Number
1342786|NCT01909778|Secondary|Tmax|Time at which the maximum plasma concentration occurs (tmax). Individual tmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||hours|||Number
1342787|NCT01909778|Primary|Cmax|Maximum plasma concentration (Cmax). Individual Cmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||ng/mL|||Number
1342788|NCT01909778|Primary|AUC 0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||h*ng/mL|||Number
1342789|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Moisturizer|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).|Day 22||||participants|||Number
1342790|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).|Day 22||||participants|||Number
1342791|NCT01909713|Secondary|Hydration (Corneometry)|"Hydration was assessed using corneometry at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Corneometry measures the hydration status of the skin. An increase in corneometry values indicates an increase in the hydration status of the skin, and vice versa. The test is procedure specific, so results are reported in arbitrary units."|Week 3||||arbitrary units||Standard Deviation|Mean
1342792|NCT01909713|Secondary|Barrier Function (TEWL)|Barrier function was assessed by measuring transepidermal water loss (TEWL) at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). TEWL measures water loss through the epidermis (for example, by evaporation). Measuring TEWL is a well-established way to assess the skin’s water-barrier function. High TEWL values indicate impaired skin barrier function; low values indicate normal barrier function.|Week 3||||g/m2/h||Standard Deviation|Mean
1342793|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Tightness: 0 = none, no tightness; 1 = mild, slight tightness, not really bothersome; 2 = moderate, definite tightness sensation that is somewhat bothersome; 3 = severe, tightness sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3||||participants|||Number
1342905|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mmHg at 37° C||Standard Deviation|Mean
1342794|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Stinging: 0 = none, no stinging; 1 = mild, slight stinging sensation, not really bothersome; 2 = moderate, definite stinging sensation that is somewhat bothersome; 3 = severe, stinging sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3||||participants|||Number
1342795|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Burning: 0 = none, no burning; 1 = mild, slight burning sensation, not really bothersome; 2 = moderate, definite warm, burning sensation that is somewhat bothersome; 3 = severe, hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3||||participants|||Number
1342796|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Roughness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin.|Week 3||||participants|||Number
1342797|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Dryness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling.|Week 3||||participants|||Number
1342798|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Edema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense.|Week 3||||participants|||Number
1342799|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Itching: 0 = none, no itching; 1 = mild, slight itching, not really bothersome; 2 = moderate, definite itching that is somewhat bothersome; 3 = severe, intense itching that may interrupt daily activities and/or sleep|Week 3||||participants|||Number
1342800|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Erythema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema.|Week 3||||participants|||Number
1342801|NCT01909674|Primary|Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks|Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.|3 weeks for each mask condition|higher values represent a better outcome|||minutes||Standard Deviation|Mean
1342802|NCT01909570|Other Pre-specified|Live Birth Delivery Rate|The delivery of a healthy child (o two)|38 weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.|||percentage of live birth|||Number
1342803|NCT01909570|Secondary|Multiple Pregnancy Rate|A multiple clinical pregnancy was defined by the presence of more tan one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.|||percentage of multiple pregnancies|||Number
1342804|NCT01909570|Primary|Clinical Pregnancy Rate|A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.|||percentage of pregnancy per transfer|||Number
1342805|NCT01909466|Secondary|Mean Change From Baseline in Social Integration Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342848|NCT01908842|Secondary|COWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable|Days 3 through 22|Full analysis population - - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
1343113|NCT01903863|Secondary|Fresh Frozen Plasma Transfusion Requirements|Compared fresh frozen plasma transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)||||ml/kilogram/ECMO day||Inter-Quartile Range|Median
1342806|NCT01909466|Secondary|Mean Change From Baseline in Emotional Regulation Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342807|NCT01909466|Secondary|Mean Change From Baseline in Physical Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342808|NCT01909466|Secondary|Mean Change From Baseline in Self Control Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342809|NCT01909466|Secondary|Mean Change From Baseline in Mental Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342810|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. The total score from the scale ranges from 20 (bad subjective experience) to 120 (perfect subjective experience).|Baseline to Week 20+|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342818|NCT01909466|Primary|Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).|The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). The SAS Total Score was the sum of the scores for all 10 items. SAS total score can range from 10 to 50. Each item was rated on a 5-point scale, with a score of 1 =absence of symptoms and a score of 5 =severe condition.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342811|NCT01909466|Secondary|Clinical Global Impression-Improvement (CGI-I) Score.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342812|NCT01909466|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342813|NCT01909466|Secondary|Mean Change From Baseline in PANSS Negative Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342814|NCT01909466|Secondary|Mean Change From Baseline in PANSS Positive Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342815|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342816|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe).|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342817|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Overall AIMS scores range from 0 to 42.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342849|NCT01908842|Secondary|Clinical Opiate Withdrawal Scale (COWS) Scores: Induction|Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable|Days 1 and 2|Full Analysis Population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
1342819|NCT01909466|Primary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).|Suicidality was monitored throughout the trial using C-SSRS. The C-SSRS addresses the need for standardized classification of suicide reports to assess suicide risk. This scale consisted of Baseline evaluation that assessed the lifetime experience of the participant with suicidal events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit. The C-SSRS since last visit form were completed on Day 1 pre-dose and prior to dosing on Days 29, 57, 85, 113, 141/ Early Termination(ET) and prior to pharmacokinetics(PK) sampling on Days 8, 15, 22, 120, 127 and 134. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore,the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.|Baseline to Last Visit (Day 141)|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342820|NCT01909466|Primary|Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.|Participants assessed the pain associated with injection of aripiprazole IM using the VAS instrument. This was done approximately 30 minutes pre-dose and 1 hour (±15 min) Post-dose on Days 1, 29, 57, 85 and 113. For the first injection, the pre-dose assessment was of the current injection site. For the injections 2 through 5, the pre-dose assessment was of the prior injection site. Investigator's Assessment of Most Recent Injection Site including pain, swelling, redness, and induration were reported in 4-point categorical scale (1 = absent, 2 = mild, 3 = moderate and 4 = severe) by first injection site at each injection.|Days 1 and 113|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
1342821|NCT01909466|Primary|Number of Participants With Adverse Events (AEs).|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|AEs were recorded from the time the informed consent was signed until follow-up for 28 days after last|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation.|||participants|||Number
1342822|NCT01909336|Secondary|Adverse Reactions Attributed to Acute Plasma Sodium Changes|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours|8 hours||||Minor Adverse Reactions|||Number
1342823|NCT01909336|Secondary|Dysnatraemias at T8|hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)|8 hours||||participants|||Number
1342824|NCT01909336|Primary|Hospital Acquired Hyponatremia|Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study|8 hours||||participants|||Number
1342825|NCT01909180|Primary|Image Quality|"Image quality assessment on a 5 point Likert Scale:~5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information~1= Non-Diagnostic"|24 hours|All cases were sufficient and had acceptable, good or excellent image quality|||units on a scale|Participants|Standard Deviation|Mean
1342826|NCT01909141|Other Pre-specified|Safety of Pioglitazone as Regards Serum Creatinine|serum creatinine was measured at the end of the study period (after 3 months) in both groups.|3 months||||mg/dL||Standard Deviation|Mean
1342827|NCT01909141|Secondary|Pregnancy Rate||3 months||||participants|||Number
1342828|NCT01909141|Secondary|Endometrial Thickness||3 months||||mm||Standard Deviation|Mean
1342829|NCT01909141|Secondary|Number of Follicles>18mm.||3 months||||follicles||Standard Deviation|Mean
1342830|NCT01909141|Primary|Ovulation Rate||3 months||||percentage of all cycles|||Number
1342831|NCT01909011|Primary|Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2|BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|Intent to treat population (all participants who received at least one dose of intervention). Last observation carried forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1342832|NCT01909011|Secondary|Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2|CGI-S instrument measures the level of severity of illness rated by a qualified clinician. CGI-S values range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1342833|NCT01909011|Secondary|Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2|Q-LES-Q is a validated 16-item self-report measure of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning such as physical well-being, work, home, social relationships and leisure activities. Each item is rated on a 1 - 5 point scale. Q-LES-Q values range from 0 (very low quality of life) to 100 (high quality of life). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1342847|NCT01908842|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction|Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable|Days 1 and 2|Full analysis population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
1342834|NCT01908907|Other Pre-specified|LCPUFA Levels - Linoleic Acid (LNA)|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|Baseline, full feedings and discharge||||wt:wt% (composition) of fat in sample||Standard Deviation|Mean
1342835|NCT01908907|Other Pre-specified|LCPUFA Levels - Alpha-linolenic Acid (ALA) in Whole Blood|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|Baseline (<1 week of age), full enteral feedings and discharge||||wt:wt% (composition) of total fat||Standard Deviation|Mean
1342836|NCT01908907|Secondary|LCPUFA Levels - Arachidonic Acid (ARA) in Whole Blood|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|At baseline (enrollment, <1 week of age), full feedings and discharge||||wt:wt% of total fat in sample||Standard Deviation|Mean
1342837|NCT01908907|Primary|Feasibility and Tolerability of Daily Enteral DHA Oil - Head Circumference|A linear mixed model was used to explore head circumference over time.|30 days from birth|||||||
1342838|NCT01908907|Primary|Feasibility and Tolerability of Daily Enteral DHA Oil - Head Circumference|A linear mixed model was used to explore head circumference over time.|30 days from birth|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made. They had DHA levels measured to be used as a reference population in our NICU.|||Centimeters per day||Standard Error|Mean
1342839|NCT01908907|Primary|Feasibility and Tolerability of Daily Enteral DHA Oil - Length Change|A linear mixed model was used to explore length over time.|30 days from birth|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made. They had DHA levels measured to be used as a reference population in our NICU.|||Centimeters per day||Standard Error|Mean
1342840|NCT01908907|Primary|Long Chain Polyunsaturated Fatty Acid (LCPUFA) Levels - Docosahexaenoic Acid (DHA) Levels in Whole Blood|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|At baseline (enrollment, < 1 week of age), full feedings, discharge||||mol% (composition) of fat||Standard Deviation|Mean
1342841|NCT01908907|Primary|Feasibility and Tolerability of Daily Enteral DHA Oil - Weight Change|A linear mixed model was used to explore weight over time.|30 days from birth|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made. They had DHA levels measured to be used as a reference population in our NICU.|||Grams per day||Standard Error|Mean
1342842|NCT01908907|Primary|Days to Reach Full Enteral Feedings and Days on Study Oil.|This study was designed to determine feasibility and tolerability of enteral DHA supplementation, but was not intended to determine the effects of DHA on health related outcomes. Tolerability was measured by days to reach full enteral feedings, days on study oil, GA at completion of the study and postnatal growth. The days to reach full enteral feedings was defined as enteral intake of 100kcal/kg/d. Safety and tolerability was closely monitored under the oversight of an independent DSMB.|From enrollment until the infant reaches full feed or is discharged from the NICU, whichever comes first, assessed up to 50 days.|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made.|||days||Standard Deviation|Mean
1342843|NCT01908842|Secondary|VAS Craving Scores: Stabilization/Maintenance|"Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 3 through 22|Full analysis population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
1342844|NCT01908842|Secondary|Visual Analog Scale (VAS) Cravings: Induction|"Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 1 and 2|Full Analysis Population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
1342845|NCT01908842|Secondary|SOWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable|Days 3 through 22|Full Analysis Population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
1342846|NCT01908842|Primary|Primary Endpoints of Retention in Treatment at Days 3 and 15|Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.|Day 3 and Day 15|Per protocol population|||participants|||Number
1342851|NCT01908829|Secondary|Number of Participants With Adverse Events (AEs)|AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.|From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)|The analysis population consisted of the Safety Analysis Set, the SAF comprised all randomized participants who received at least 1 dose of double-blind treatment.|||Participants|||Count of Participants
1342852|NCT01908829|Secondary|Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
1342853|NCT01908829|Secondary|Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
1342854|NCT01908829|Secondary|Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score|HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
1342855|NCT01908829|Secondary|Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
1342856|NCT01908829|Secondary|Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline|Micturitions were defined as voluntary urinations (excluding incontinence only episodes).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
1342857|NCT01908829|Secondary|Percentage of Participants With Zero Incontinence Episodes Postbaseline|Incontinence was defined as any involuntary leakage of urine.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
1342858|NCT01908829|Secondary|Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours|Incontinence was defined as any involuntary leakage of urine.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
1342859|NCT01908829|Secondary|Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)|The PGIC was a 2-part questionnaire, assessing both the change in the participant’s overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant’s change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).|End of treatment (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
1342860|NCT01908829|Secondary|Change From Baseline in Patient Perception Bladder Control (PPBC) Score|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342861|NCT01908829|Secondary|Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score|The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342862|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342863|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Sleep|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342906|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||pCO2 (mmHg at 37° C)||Standard Deviation|Mean
1342864|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Concern|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342865|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Coping|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342866|NCT01908829|Secondary|Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342867|NCT01908829|Secondary|Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
1342868|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
1342869|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
1342870|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
1342871|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
1342872|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
1342873|NCT01908829|Secondary|Number of Nocturia Episodes Reported Over 3-Day Diary|The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.|||nocturia episodes||Standard Error|Mean
1342884|NCT01908829|Secondary|Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|The analysis population consisted of the FAS with data available at each time point.|||incontinence episodes||Standard Error|Least Squares Mean
1342907|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||pH||Standard Deviation|Mean
1342874|NCT01908829|Secondary|Change From Baseline in Mean Number of Nocturia Episodes|Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.|||nocturia episodes||Standard Error|Least Squares Mean
1342875|NCT01908829|Secondary|Number of Pads Used During the 3-Day Diary|The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants who reported use of at least one pad in baseline diary were included.|||pads||Standard Error|Mean
1342876|NCT01908829|Secondary|Change From Baseline in Mean Number of Pads Per 24 Hours|The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with reported use of at least one pad reported in baseline diary were included.|||pads||Standard Error|Least Squares Mean
1342877|NCT01908829|Secondary|Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one urgency episode reported in baseline diary were included.|||urgency episodes||Standard Error|Least Squares Mean
1342878|NCT01908829|Secondary|Number of UI Episodes Reported During the 3-Day Diary|Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.|||UI episodes||Standard Error|Mean
1342879|NCT01908829|Secondary|Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours|UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or ‘both’ was recorded & severity of urinary urgency recorded was 3 or 4.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.|||UI episodes||Standard Error|Least Squares Mean
1342880|NCT01908829|Secondary|Change From Baseline to EoT in Corrected Micturition Frequency (CMF)|CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.|Baseline and EoT (up to 12 weeks)|LOCF was used. The analysis population consisted of the FAS.|||micturitions||Standard Error|Least Squares Mean
1342881|NCT01908829|Secondary|Change From Baseline in Mean Volume Voided (MVV) Per Micturition|MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||mL||Standard Error|Least Squares Mean
1342882|NCT01908829|Secondary|Number of Incontinence Episodes Reported During the 3-Day Diary|The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||incontinence episodes||Standard Error|Mean
1342883|NCT01908829|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||micturitions||Standard Error|Least Squares Mean
1342885|NCT01908829|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.|Baseline and end of treatment (up to 12 weeks)|The analysis population consisted of the FAS. LOCF was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
1342886|NCT01908803|Secondary|Median Time (in Days) to Cessation of Otorrhea|Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.|Time to event, up to Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.|||days||Standard Error|Median
1342887|NCT01908803|Secondary|Proportion of Subjects With Microbiological Success at the Day 8 Visit|Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.|Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.|||percentage of subjects||Standard Deviation|Mean
1342888|NCT01908803|Primary|Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit|A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.|Day 3 post-treatment up to Day 8 or Early Exit|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.|||percentage of subjects|||Number
1342889|NCT01908140|Secondary|Transition Dyspnoea Index (TDI) Focal Score at Week 24|The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 (“major deterioration”) to zero (“no change”) to +3 (“major improvement”). Category scores are added to compute the Focal Score (from -9 to 9)|At Week 24|PP population defined as a subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol.|||TDI Focal Score|Participants|Standard Error|Least Squares Mean
1342890|NCT01908140|Primary|Peak Forced Expiratory Volume in One Second (FEV1) at Week 24|Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration|At Week 24|"ITT population: randomized patients who took at least one dose of IMP and have a baseline FEV1 assessment.~PP population: subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol."|||Liters|Participants|Standard Error|Least Squares Mean
1342891|NCT01908127|Secondary|Index of Heart Rate|The heart rate of children was measured before the injection of local anesthesia solution to save a baseline data and it was also measured after the injection to assess the effect of this dental stress.|before and after the injection of local anesthesia solution||||beat per Min||Standard Deviation|Mean
1342892|NCT01908127|Primary|Behaviors of Children|"A video-camera was focused started to record child’s behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children’s anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used.~Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact~Table 2: Frankle 4-point Index~1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)"|participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks||||units on a scale||Standard Deviation|Mean
1342893|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||% of volume||Standard Deviation|Mean
1342894|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||% of volume||Standard Deviation|Mean
1342895|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/mL||Standard Deviation|Mean
1342896|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/mL||Standard Deviation|Mean
1342897|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
1342898|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
1342908|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||pH (at 37° C)||Standard Deviation|Mean
1342909|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||g/dL||Standard Deviation|Mean
1342910|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||g/dL||Standard Deviation|Mean
1342911|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||10E3 cells/µL||Standard Deviation|Mean
1342912|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||10E3 cells/µL||Standard Deviation|Mean
1342913|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/g Hgb||Standard Deviation|Mean
1342914|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/g Hgb||Standard Deviation|Mean
1342915|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||volume % of red blood cells||Standard Deviation|Mean
1342916|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||% of volume||Standard Deviation|Mean
1342917|NCT01907906|Secondary|Neoantigenicity - Day 42 Indirect Antigen Test (IAT)|IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 42 of both Treatment Periods 1 and 2.|||Positive results|||Number
1342918|NCT01907906|Secondary|Neoantigenicity - Day 42 Direct Antigen Test (DAT)|DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||Positive results|||Number
1342919|NCT01907906|Secondary|Neoantigenicity - Day 21 Indirect Antigen Test (IAT)|Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 21 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2|||Positive results|||Number
1342920|NCT01907906|Secondary|Neoantigenicity - Day 21 Direct Antigen Test (DAT)|DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.|Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2|||Positive results|||Number
1342921|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
1342922|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
1342923|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
1342924|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
1342925|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
1342926|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
1342927|NCT01907906|Secondary|Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival|Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Days * Percent Recovery||Standard Deviation|Mean
1342928|NCT01907906|Secondary|Red Blood Cell (RBC) Survival by Product|Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.|28 days|All subjects who signed informed consent,were eligible, had no intercurrent illness or notable signs/symptoms in 24 hrs prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had ≥ 4 blood samples collected within the first 22 min 30 sec post-infusion in each treatment period.|||Days||Standard Deviation|Mean
1342929|NCT01907906|Primary|Red Blood Cell (RBC) 24-Hour Recovery|"To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days.~24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days."|24 hours|All subjects who signed an IC form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected during the first 22 min, 30 sec post-infusion in each treatment period.|||% 24-hour RBC Recovery||Standard Deviation|Mean
1342930|NCT01907854|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.|During 26 weeks of treatment plus one week follow-up period.|Safety analysis set-All randomised subjects receiving at least one dose of any of the trial product.|||number of events|||Number
1342931|NCT01907854|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)|Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|After 26 weeks of treatment|FAS-All randomised subjects receiving at least one dose of any of the trial product.|||percentage (%)|||Number
1342932|NCT01907854|Secondary|Change in Systolic Blood Pressure and Diastolic Blood Pressure|Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product|||mmHg||Standard Deviation|Mean
1342933|NCT01907854|Secondary|Change in Fasting Blood Lipids|Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.|From baseline to week 26|FAS-All randomised subjects receiving at least one dose of any of the trial product. There were missing baseline values for free fatty acids in 1 subject in the liraglutide arm and 6 subjects in the sitagliptin arm.|||ratio||Standard Deviation|Mean
1342934|NCT01907854|Secondary|Change in Fasting Plasma Glucose|Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.|||nmol/L||Standard Deviation|Mean
1342935|NCT01907854|Secondary|Change in Body Weight|Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.|||kg||Standard Deviation|Mean
1342936|NCT01907854|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).|From baseline to week 26|Full analysis set (FAS) -All randomised subjects receiving at least one dose of any of the trial product.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1342937|NCT01907815|Other Pre-specified|Percentage Change in Cellular Proteins|The 95% confidence interval will be assessed.|Baseline to day 28 post treatment|||||||
1342938|NCT01907815|Other Pre-specified|Maximum Percentage Change in Total and Phospho-proteins|Change in total and phospho-proteins assessed by densitometric quantitative data by western blot analysis, or mean fluorescent intensities by flow cytometry and will be assessed for each patient for all time points and graphically plotted for each dose level.|Baseline to 12 weeks post therapy|||||||
1342939|NCT01907815|Secondary|Time to Progression for Participants Achieving CR/CRp|Time to Progression (TTP) is defined as the length of time from the start of treatment to disease progression as measured in days for participants with complete response.|Up to 12 weeks|Outcome data were not collected and the Outcome will never be analyzed.||||||
1342940|NCT01907815|Secondary|Progression Free Survival of Participants Achieving CR/CRp|Estimated disease-free survival period using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 12 weeks|No participants achieved CR/CRp therefore analysis not available.||||||
1342941|NCT01907815|Secondary|Overall Survival of Participants Achieving CR/CRp|Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 12 weeks|No participants achieved CR/CRp therefore analysis not available.||||||
1342942|NCT01907815|Secondary|Most Frequently Reported Adverse Events (AE)|National Cancer Institute (NCI) published standardized definitions for adverse events (AEs), known as Common Terminology Criteria for Adverse Events (CTCAE), to describe the severity of organ toxicity for those receiving cancer therapy. Toxicity data is summarized by number of incidents experienced while participants were on study using most frequently reported AEs regardless of grade or relatedness as assessed by CTCAE version 4.0. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved. Death (Grade 5) is used for some of the criteria to denote a fatality. For full adverse event reporting see Adverse Event Section. Data collection over first four cycles (16 weeks) of therapy, with evaluation after full cycle of therapy (28 days), continuing AE collection until 28 days following last study drug dose.|AE collected continuously over 28-day cycles and up to 28 days after last dose of study drug.|One participant of the 17 registered in first cohort (Trametinib 2.0) withdrew without treatment and is excluded from adverse event reporting.|||events|||Number
1342943|NCT01907815|Primary|Complete Response Rate (CRR, Defined as CR+CRp) Assessed by AML 2003 Response Criteria|Proportion of participants achieving complete remission (CR) or CR with incomplete recovery of platelets (CRp) as best response within 4 cycles of therapy. Complete Response (CR): Disappearance all clinical &/or radiologic evidence of disease. Neutrophil count ≥ 1.0x10^9/L; Platelet count ≥ 100x109/L; Normal bone marrow differential (≤ 5% blasts); No extra-medullary leukemia. Complete Remission without Platelet Recovery (CRp): Peripheral blood & bone marrow results as for CR, but platelet counts of < 100x10^9/L. Partial Remission (PR): Blood count recovery as for CR, but decrease of at least 50% in % marrow blasts to >5% to 25% in bone marrow aspirate. Morphologic leukemia-free state: Normal marrow differential (<5% blasts); neutrophil & platelet counts not considered.95% confidence interval will be estimated for the combination regimen.|First four cycles (16 weeks) of therapy, with evaluation after one full cycle of therapy (28 days) and up to 16 weeks for response|One participant in first cohort withdrew prior to treatment therefore excluded from study analysis.|||percentage of participants|||Number
1342944|NCT01907516|Secondary|Subject Satisfaction|Satisfaction was measured with a survey after completing using both reporting methods|6 weeks||||percentage of participants|||Number
1342945|NCT01907516|Primary|Compliance With Home Blood Glucose Reporting|Compliance was calculated as a percentage for each method (Confidant or Voicemail) by dividing the total number of reported glucose readings among all participants by the total number of expected readings (4 daily) over the 6 week study time period. Women with gestational diabetes are instructed to monitor their glucose 4 times per day.|6 weeks||||percentage of expected glucose tests|||Number
1342946|NCT01907490|Secondary|PK Parameters: AUC|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||2017-08-31|08/2017||||
1342947|NCT01907490|Secondary|PK Parameters: Tmax|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||2017-08-31|08/2017||||
1342948|NCT01907490|Secondary|Pk Parameters: Cmax|Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation|3 months||2017-08-31|08/2017||||
1342949|NCT01907490|Primary|Number of the Subjects With AEs.|Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.|3 months|paediatric population, children between ages 6 months to <18 years.|||participants|||Number
1342950|NCT01907334|Primary|Total Airway Resistance Increase|concentration of methacholine required to increase total airway resistance by 40% (PC40R5)|1 to 7 days|The analysis was performed on all 10 participants.|||ln(mg/mL)||95% Confidence Interval|Geometric Mean
1342951|NCT01907321|Secondary|Cough Expiratory Airflow|Cough airflow measure of peak expiratory flow rate|Change in baseline to 7 weeks|14 adults with a history of ischemic stroke in the previous 2 years. All but two participants (1 male, 1 female) completed the protocol.|||Liters of air/second||Standard Deviation|Mean
1342952|NCT01907321|Primary|Maximum Expiratory Pressure|This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.|Change in baseline to week 7|Data from 14 adults with a history of ischemic stroke was analyzed for changes in maximum expiratory pressure generating capacity, cough strength, and swallowing safety. All but 2 participants (1 male, 1 female) completed the protocol. Intent to treat analysis was used.|||cm H2O (pressure measurement)||Standard Deviation|Mean
1342953|NCT01907269|Other Pre-specified|Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care||6 and 18 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders.|||Participants|||Count of Participants
1342954|NCT01907269|Secondary|Number of Participants That Initiate an Osteoporosis Prescription Medication|We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.|18 months||||Participants|||Count of Participants
1342970|NCT01907113|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||h||Geometric Coefficient of Variation|Geometric Mean
1342955|NCT01907269|Secondary|Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing|Self-report of a receipt of a DXA scan (Bone Mineral Density test).|6 and 18 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders. Surveys for BMD (18 months) included 3 responses. If participants marked option (2) that they had received a BMD, but > 12 months ago they were excluded from analyses. Thus our overall population analyzed (those marking response 1 or 3) is different than our participant flow.|||Participants|||Count of Participants
1342956|NCT01907269|Secondary|Number of Participants Who Reported Use of Calcium and Vitamin D|We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.|6 and 18 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders.|||Participants|||Count of Participants
1342957|NCT01907269|Primary|Number of Participants That Initiate an Osteoporosis Prescription Medication|We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.|6 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders.|||Participants|||Count of Participants
1342958|NCT01907113|Secondary|Assessment of Tolerability by Investigator|Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation.|Drug administration until end-of-study-examination, 5 days|Treated set|||participants|||Number
1342959|NCT01907113|Secondary|Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements|Number of participants with clinically relevant findings in physical examination, Vital Signs, Clinically Significant Abnormalities in Electrocardiogram (ECG) and Significant Changes from Baseline Laboratory Measurements|Drug administration until end-of-study-examination, 5 days|Treated set|||participants|||Number
1342960|NCT01907113|Secondary|Total Urinary Glucose Excretion (UGE)|Change from baseline in total urinary glucose excretion|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE)|The UGE analysis set included all patients in the treated set who provided the baseline value from 0 to 24 hours before drug administration and the value for urinary glucose excretion from 0 to 24 hours after drug administration without important protocol violations relevant to the evaluation of Pharmacodynamics.|||mg||Standard Error|Mean
1342961|NCT01907113|Secondary|Plasma Protein Binding|"Plasma protein binding is the percent of analyte binding to the plasma protein, pre-dose plasma samples were spiked with Empa 1000 nmol/L.~The standard deviation is actually the coefficient of variation."|1 h before drug administration and 1:30 and 3:00 h after drug administration|PKS|||percentage of plasma protein binding||Standard Deviation|Mean
1342962|NCT01907113|Secondary|%AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity)|Percentage of area under the concentration-time curve of the analyte in plasma over the time interval from the time of the last quantifiable data point extrapolated to infinity|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||percent||Geometric Coefficient of Variation|Geometric Mean
1342963|NCT01907113|Secondary|Renal Clearance of the Analyte in Plasma After Extravascular Administration|Renal Clearance of the Analyte in Plasma After Extravascular Administration for time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1342964|NCT01907113|Secondary|fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours)|Fraction of analyte excreted unchanged in urine from time point 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS|||percentage of analyte||Geometric Coefficient of Variation|Geometric Mean
1342965|NCT01907113|Secondary|Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h)|Amount of analyte that is eliminated in urine over the time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS|||nmol||Geometric Coefficient of Variation|Geometric Mean
1342966|NCT01907113|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1342967|NCT01907113|Secondary|Apparent Volume of Distribution During the Terminal Phase Lz|Apparent volume of distribution during the terminal phase Lz|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||L||Geometric Coefficient of Variation|Geometric Mean
1342968|NCT01907113|Secondary|Apparent Clearance of the Analyte in the Plasma After Extravascular Administration|Apparent clearance of the analyte in the plasma after extravascular administration|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1342969|NCT01907113|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma (Lz)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||1/h||Geometric Coefficient of Variation|Geometric Mean
1342971|NCT01907113|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||h||Full Range|Median
1342972|NCT01907113|Primary|Cmax (Maximum Concentration of the Analyte in Plasma)|Maximum concentration of Empagliflozin in plasma|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1342973|NCT01907113|Primary|AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity)|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|The PK analysis set (PKS) included all evaluable patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1342974|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Whole Brain Apparent Diffusion Coefficient|Percentage changes in whole brain apparent diffusion coefficient from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
1342975|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Volume of Cerebrospinal Fluid|Percentage changes in volume of cerebrospinal fluid from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
1342976|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Total White Matter Volume|Percentage changes in total white matter volume from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
1342977|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Volume of Total Grey Matter|Percentage changes in volume of total grey matter from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
1342978|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Whole Brain Volume|Percentage changes in whole brain volume from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
1342979|NCT01907087|Primary|Motor-Language (ML) Scale Score During 300 mg Dosing Period|The progression of ceroid lipofuscinosis (CLN2) disease was assessed using adapted motor and language domains of the Hamburg rating scale (ML scale score). Motor and Language are each 0 - 3 point subscales in which 3 represents best function and 0 represents loss of function. The sum of the motor and language scores (ML score, 0-6 points) was used to evaluate the loss of function.|Baseline, Week 49/Last Assessment|Intent to Treat (ITT) Population : all study subjects receiving > 1 dose|||units on a scale||Standard Deviation|Mean
1342980|NCT01906658|Secondary|Proportion of Subjects With Treatment Emergent Suicidality||Baseline to Week 36||||Participants|||Count of Participants
1342981|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication||Baseline to Week 8||||Participants|||Count of Participants
1342982|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation||Baseline to Week 8||||Participants|||Count of Participants
1342983|NCT01906658|Primary|Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication||Baseline to Week 8||||Participants|||Count of Participants
1342984|NCT01906515|Primary|The Effect of SpHb on Transfusion Timeline|Length of time it takes to initiate a RBC transfusion after the need was first established.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.|||minutes||95% Confidence Interval|Mean
1342985|NCT01906515|Primary|RBC Transfusions Per Subject Receiving a Transfusion|Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.|||units||95% Confidence Interval|Mean
1342986|NCT01906515|Other Pre-specified|Potential Cost Savings|Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294.|During surgery (an average of about 4 hours)|||||||
1342987|NCT01906515|Secondary|SpHb Absolute and Trend Accuracy|To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated|During surgery (an average of about 4 hours)|||||||
1342988|NCT01906372|Secondary|Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.|Mean change in glucocorticoid dose (equivalent prednisone dose) at 24 weeks compared to baseline.|Steroid sparing effect and safety and tolerability at 24 weeks compared to baseline||||mg||Standard Deviation|Mean
1342989|NCT01906372|Primary|Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).|3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the MMT). The DOI should be met at least once on any of the 6 follow up visits and maintained until week 24. Subjects not meeting DOI during the trial are treatment failures.|Primary end point: IMACS preliminary definition of improvement (DOI)|Total of 10 PM/DM patients completed the study.One additional patient dropped out of the study at 6 weeks due to worsening of conduction abnormalities (heart block unrelated to the study drug).The patient had not completed minimum 8 weeks of study drug required for outcome assessment as per study protocol, and was not included in primary analysis.|||Participants|||Count of Participants
1342990|NCT01905956|Secondary|Global Evaluation of Safety by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
1342991|NCT01905956|Secondary|Global Evaluation of Safety by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
1342992|NCT01905956|Secondary|Global Evaluation of Efficacy by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
1342993|NCT01905956|Secondary|Global Evaluation of Efficacy by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
1342994|NCT01905956|Secondary|Food Craving Questionnaire (FCQ)|"This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale:~= I do not agree at all~= I do not agree~= Neutral~= I agree~= I highly agree~Results were expressed as the mean score for the whole population in the respective intervention group."|Baseline and 4, 8, and 12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the FCQ at all visits from v2 to v5. Missing data were appeared in 9 cases at visit v5 and additional in 8 cases at visit v4.|||Units on a scale||Standard Deviation|Mean
1342995|NCT01905956|Secondary|Mean Change in Body Fat Mass (kg) From Baseline to Week 12|"Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.|||kilogram (kg)||Standard Deviation|Mean
1342996|NCT01905956|Secondary|Mean Change in Body Fat Content (%) From Baseline to Week 12|"Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.|||Percentage of body fat (%)||Standard Deviation|Mean
1342997|NCT01905956|Secondary|Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12|"Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest.~Hip circumference (cm) was measured as the maximal circumference over the buttocks.~Results were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values)."|Baseline and 12 weeks||||centimetre (cm)||Standard Deviation|Mean
1342998|NCT01905956|Primary|Mean Change in Body Weight From Baseline to Week 12|"Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values)."|Baseline and 12 weeks||||kilogram (kg)||Standard Deviation|Mean
1342999|NCT01905683|Secondary|Changes in Gross Motor Function Measure (GMFM)-66 Score From Baseline to All Injection Visits and End of Study|The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).|Baseline to Day 1 of 2nd (V5), 3rd (V7), 4th (V9) IC and End of study (Week 44-68) (V11)|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. Therefore all participants from lead-in study were included in FAS.|||units on a scale||Standard Deviation|Mean
1343000|NCT01905683|Secondary|Change in Scores of Pain Intensity (From Participants) and Frequency (From Parent/Caregiver) From Baseline to All Visits, From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC Cycle Only) and Day 99 (Week 14) of Respective Injection|The questionnaire on pain caused by Spasticity (QPS) is a participant-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with QPS. The QPS total score for pain intensity ranges from 0 (’No Hurt’) to 10 (’Hurt Worst’). The QPS total score for the observed pain frequency ranges from 0 (Never) to 4 (Always). V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5= Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit.|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
1343033|NCT01904773|Primary|Total Tic Severity Score (Part 2 Only) Crossover Analysis Over 6 Periods|Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50|3 week period of treatment|All Part 2 participants|||Total Tic Severity Score||Standard Error|Least Squares Mean
1343001|NCT01905683|Secondary|Changes in Modified Tardieu Scale (MTS) of Left and Right PF From Baseline to All Other Visits, From Day 1 of Each Injection Cycle (IC) to Day 29 (Week 4), Day 57 (Week 8, 1st IC Only) and Day 99 (Week 14) of the Respective Injection Cycle|"The MTS assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a catch-and-release or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, that is, the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, that is, improvement of dynamic muscle spasticity. V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5 = Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit."|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||Degrees||Standard Deviation|Mean
1343002|NCT01905683|Secondary|Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of Left and Right PF at Day 29 (Week 4) of Each Injection Cycle|The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is a 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for efficacy analysis that is “primary body side” was decided by investigator at screening and was kept throughout the entire study.|Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
1343003|NCT01905683|Secondary|Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale (GICS) at Day 29 (Week 4) of Each Injection Cycle|The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function).|Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
1343004|NCT01905683|Secondary|Changes in AS Score of Left and Right Plantar Flexors (PF) From Baseline to All Other Visits, From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle Only) and Day 99 (Week 14) of the Respective Injection Cycle|The Ashworth Scale (AS) is a well-known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for efficacy analysis that is, “primary body side” was decided by investigator at screening and was kept throughout the entire study. V3 = Week 4 of 1st Injection Cycle; V4 = Week 8 of 1st Injection Cycle; V5 = Day 1 of 2nd Injection Cycle; V6= Week 4 of 2nd Injection Cycle; V7 = Day 1 of 3rd Injection Cycle; V8 = Week 4 of 3rd Injection Cycle; V9 = Day 1 of 4th Injection Cycle; V10 = Week 4 of 4th Injection Cycle; V11= Week 14th of 4th Injection Cycle = end of study visit.|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle only) and Day 99 (Week 14) of the respective Injection Cycle|The full analysis set (FAS) was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
1343005|NCT01905683|Secondary|Investigator’s Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle|The investigator’s global assessment of tolerability was assessed on a 4-point ordinal scale where 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Results for Day 99 (Week 14) of 4th injection cycles were collected at the end of study visit.|Day 99 (Week 14) of 1st, 2nd, 3rd and 4th injection cycle|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
1343006|NCT01905683|Primary|Occurrence of Treatment-emergent Serious Adverse Events (TESAEs) Overall and Per Injection Cycle|TESAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.|From the timepoint of first injection until end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
1343007|NCT01905683|Primary|Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle|TEAEs occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as TEAESI. Values reported here refer to the number of participants affected.|From the timepoint of first injection until end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
1343008|NCT01905683|Primary|Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle|TEAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.|From the timepoint of first injection up to end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
1343034|NCT01904760|Other Pre-specified|Pain Score Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their pain score are evaluated by VAS method every afternoon on each of the 5 days. Patients' pain score on maxillofacial region and flap donation region are evaluated respectively.|on each of the 5 days postoperatively|||||||
1343035|NCT01904760|Other Pre-specified|Sleep Quality Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their sleep quality are evaluated every afternoon on each of the 5 days.|on each of the 5 days postoperatively|||||||
1343009|NCT01905657|Secondary|Duration of Response (DOR) by RECIST 1.1|DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized. Participants were included in the treatment group to which they were randomized.|||Weeks||Full Range|Median
1343010|NCT01905657|Secondary|Overall Response Rate (ORR) by RECIST 1.1|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) based on blinded independent central radiologists' review using RECIST 1.1.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
1343011|NCT01905657|Primary|Percentage of Participants Discontinuing Study Drug Due to AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE.|Up to approximately 23 months|The APAT population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.|||Percentage of Participants|||Number
1343012|NCT01905657|Primary|Percentage of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days after last dose of study drug (serious AEs were monitored for up to 90 days after last dose of study drug).|AEs: Up to 30 days after last dose of study drug (Up to approximately 24 months). Serious AEs: Up to 90 days after last dose of study drug (Up to approximately 27 months).|The All Participants As Treated (APAT) population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.|||Percentage of Participants|||Number
1343013|NCT01905657|Primary|Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists’ review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1343014|NCT01905657|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The Intent-To-Treat population consisted of all participants who were randomized and were included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1343015|NCT01905553|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose||||ng/mL||Standard Deviation|Mean
1343016|NCT01905553|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions|AUClast is the area under the curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
1343017|NCT01905553|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions|AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 Hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
1343018|NCT01905540|Secondary|Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
1343019|NCT01905540|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses|AUCinf is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
1343020|NCT01905540|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
1343021|NCT01905540|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
1343022|NCT01905540|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose|AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/mL||Standard Deviation|Mean
1343023|NCT01905540|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose|AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/mL||Standard Deviation|Mean
1343024|NCT01905423|Secondary|Filarial Antigenemia in Blood and Worm Parasite Eggs in Stool by Microscopy|Secondary outcomes for the study include prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test) and prevalence of worm eggs in stool detected by the Kato-Katz test. Both of these prevalence outcomes are qualitative with no units of measure (positive or negative). Prevalence date are expressed as % positive. Other secondary outcome measures will be intensity of parasite infections (microfilariae per ml of blood and the number of worm eggs per gram of stool).|4 years|Not all participants were tested for antigen or provided stool to determine prevalence of worm eggs.|||Participants|||Count of Participants
1343025|NCT01905423|Primary|Microfilaria Prevalence in Blood by Microscopy|Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual community surveys. Microfilaremia is a categorical variable (positive or negative). Prevalence rates are expressed as % positive.|4 years|Analysis excludes participants from Pekalongan study site that were dropped after the first follow-up due to lower than expected filariasis prevalence.|||Participants|||Count of Participants
1343026|NCT01905267|Secondary|Change in Reynolds Adolescent Depression Scale|Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.|Baseline, 8 week|8 week completers sample|||units on a scale||Standard Deviation|Mean
1343027|NCT01905267|Primary|Change in Children's Depression Rating Scale - Revised|clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms|Baseline, 8 week|completers sample|||units on a scale||Standard Deviation|Mean
1343028|NCT01905254|Primary|Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis|The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy.|Transient Elastography compared to liver histology|Sensitivity, specifity; Positive and negative predictive value of TE for diagnosis of cirrhosis was analyzed.|||Probability|||Number
1343029|NCT01904864|Primary|Hemoglobin Concentration Over Time|The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment. The primary analysis consists of a linear mixed regression model, which incorporates all subsequent time points into the model and includes treatment and time as covariates and patient random effects to account for correlation among longitudinal measurements from the same patients.|12 weeks||||g/dL||Standard Deviation|Mean
1343030|NCT01904773|Primary|Pharmacokinetics : AUC (h*ng/ ml) - Part 1 Only|Pharmacokinetics Part 1 only: Single dose Day 1 AZD5213 0.5 mg Area Under the Concentration time curve (AUC) 0 to infinity (h*ng/ml)|Day 1|Pharmacokinetic population|||AUC (h*ng/ml)||Standard Deviation|Mean
1343031|NCT01904773|Primary|Pharmacokinetics : Time to Maximum Concentration (hr) - Part 1 Only|Pharmacokinetics Part 1 only: Time to maximum plasma concentration (hr)Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population|||Time (hr)||Standard Deviation|Mean
1343032|NCT01904773|Primary|Pharmacokinetics : Maximum Plasma Concentration (ng/ml) - Part 1 Only|Pharmacokinetics Part 1 only: Maximum plasma Concentration (ng/ml) Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population|||Plasma concentration (ng/ml)||Standard Deviation|Mean
1343036|NCT01904760|Other Pre-specified|Overall Feeling in PACU|Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day|||||||
1343039|NCT01904760|Other Pre-specified|Use of Analgesics and Sedatives in PACU|extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them.|participants will be followed for the duration of PACU stay, an expected average of 12 hours|||||||
1343040|NCT01904760|Other Pre-specified|Patients' Vital Signs in PACU|Patient's vital signs including heart rate, blood pressure, pulse oxygen saturation and respiratory rate are monitored continuously in PACU and recorded on 1,2,4,6,12 hour after PACU admission.|participants will be followed for the duration of PACU stay, an expected average of 12 hours|||||||
1343041|NCT01904760|Secondary|Postoperative Delirium|Patients are sent back to wards the next morning after operation and followed up on each of the 5 days postoperatively. Delirium will be confirmed based on CAM-ICU method.|on each of the 5 days postoperatively||||participants|||Number
1343042|NCT01904760|Primary|Agitation in PACU|Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.|participants will be followed for the duration of PACU stay, an expected average of 12 hours||||participants|||Number
1343043|NCT01904721|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Intensity Units||Standard Deviation|Mean
1343044|NCT01904721|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||mm/cm2||Standard Deviation|Mean
1343045|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Percentage of Participants|||Number
1343046|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Percentage of Participants|||Number
1343047|NCT01904721|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Percentage of Participants|||Number
1343048|NCT01904721|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||terminal hairs/cm2||Standard Deviation|Mean
1343049|NCT01904604|Secondary|Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy|Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.|Month 30 (Week 130)||2019-12-31|12/2019||||
1343050|NCT01904604|Secondary|Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months|Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.|Week 52 and Month 30 (Week 130)|All randomized subjects who received study treatment.|||percentage of participants|||Number
1343051|NCT01904604|Secondary|Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC)|Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.|8 and 20 weeks after the Week 130 (Month 30) OFC||2019-12-31|12/2019||||
1343052|NCT01904604|Secondary|Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.|Week 52|All randomized subjects who completed the Week 52 OFC.|||mg protein||Full Range|Median
1343053|NCT01904604|Secondary|Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:~0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52.~BL=Baseline, Wk 52=Week 52"|Week 52|All randomized subjects who received active (not placebo) study treatment.|||percentage of participants|||Number
1343054|NCT01904604|Secondary|Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein|Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC).|Week 130 (Month 30)||2019-12-31|12/2019||||
1343055|NCT01904604|Secondary|Percentage of Subjects Desensitized to Peanut Protein|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:~1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130.~BL=Baseline, Wk 130=Week 130 (Month 30)"|Week 130 (Month 30)||2019-12-31|12/2019||||
1343056|NCT01904604|Primary|Percentage of Subjects With a Successful Treatment Response|Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.|Week 52|All randomized subjects who received study treatment.|||percentage of participants|||Number
1343057|NCT01904526|Secondary|Systolic Blood Pressure|Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., systolic blood pressure)|Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)|Last day of titration period: 3 mg/day IR (Day 21) followed by 4 mg/kg ER (Day 48) followed by 6 mg/day ER (Day 57)|||mmHg||Standard Error|Mean
1343058|NCT01904526|Secondary|Heart Rate|Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., heart rate)|Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)|Last day of titration period: 3 mg/day IR (Day 21) followed by 4mg/day ER (Day 48) followed by 6mg/day ER (Day 57)|||beats per minute||Standard Error|Mean
1343059|NCT01904526|Primary|Plasma Trough Levels of Guanfacine|Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose|+24 hours on Lab Session days (Days 22, 49, 58)|3 mg/day IR (Day 22) followed by 4mg/day ER (Day 49) followed by 6mg/day ER (Day 58)|||ng/ml||Standard Error|Mean
1343060|NCT01904448|Secondary|Pre-School Language Scale (PLS-5) Scores|The PLS-5 is a standardized language test designed for infants and young children. The Auditory Comprehension subscale targets skills known to precede language development, including: attention to speakers, appropriate object play, basic vocabulary, concepts, grammatical markers, and complex sentences. The Expressive Communication subscale assesses vocal development, social communication, naming of common objects, phonological awareness, sequencing skills, as well as use of concepts, prepositions, grammatical markers, and varying sentence structures.|Year 1, Year 2, Year 3|Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.||||||
1343061|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-ESP Standard|A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure. This may have been due to child's age or inability to complete task. The Early Speech Perception (ESP) Standard measures the progression of speech discrimination skills in children (age 5+) with profound hearing loss as they develop. The stimuli consist of 3 subtests [1) patterns and words, 2) monosyllable, 3) spondees] of 12 pictured words each presented in an auditory-only condition. The format is a closed-set. Two repetitions of each item are given for a total of 24 items for each subtest. Each subtest is scored by the percent of correctly identified items from the set of pictured words.|Year 1, Year 2, Year 3|Missing values indicate test was not administered at that interval and ESP-LV (Low Verbal) was administered.|||percentage of correct answers|||Number
1343062|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-ESP Low Verbal|"A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.~The Early Speech Perception (ESP) low verbal version estimates speech perception abilities in very young children who have limited verbal abilities. Stimuli consist of words varying in pattern as well as spondees and monosyllabic words presented in sets of four. The format is four item closed-set. Test materials consist of objects (toys) instead of pictures. It is scored by the percent of correctly identified items from the set of 4; 3 repetitions of each item are given for a total of 12 trials."|Year 1, Year 2, Year 3|Missing values indicate test was not administered at that interval and ESP-Standard was administered.|||percentage of correct answers|||Number
1343063|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-Ling Sound Test|"A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.~The Ling- 6 sounds test is a speech sound detection measurement of detection thresholds performed by an audiologist. Six sound files of “ah”, “ee”, “oo”, “sh”, “s”, and “m” are presented one at a time in varying order for measurement of hearing threshold groups, per sound. The selected sounds tested validate hearing device fitting across the frequency range important for understanding speech. If the child can detect the stimuli a point is given and if they can not detect, no point is given. A total of 3 trials per sound were presented for a total of 18 presentations. The score reflects a percent of the total sounds that were detected."|Year 1, Year 2, Year 3|Single-arm study of Auditory Brainstem Implantation (ABI) in children|||percent correct|||Number
1343078|NCT01904448|Primary|Number of ABI Complications|Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.|Year 3||||Events|||Number
1343064|NCT01904448|Secondary|Speech Perception Test Battery Scores-IT-MAIS or MAIS|"A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until demonstrating a minimum performance on the previous measure.~The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) is a parent questionnaire consisting of ten questions regarding a young infant or toddler's auditory behavior, e.g., Does the child spontaneously respond to his/her name in quiet with auditory cues? Each question is scored on a five point scale: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The aim of this tool is to assess the benefit of the child's personal amplification device(s) and is used to assess hearing aid benefit. Higher scores reflect more consistent auditory response. Scores reported are the percentage of correctly answered questions of the total asked."|Pre-ABI, Year 1, Year 2, Year 3||||percent correct|||Number
1343065|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-Detection Audiogram|Sound detection for octave frequencies of 250 Hz through 8k Hz were collected and a 4 frequency average was calculated for each annual test interval|Year 1, Year 2, Year 3||||averaged decibel level|||Number
1343066|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues|Measure of percent correct on consonant voicing cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct voicing of consonant production on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343067|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues|Measure of percent correct on consonant place cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct place of consonant production on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343068|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants|Measure of percent correct on final consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced a final consonant on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343069|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues|Measure of percent correct on consonant manner cues production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct manner of consonant production on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343070|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels|Measure of percent correct on vowel production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct vowel on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343071|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants|Measure of percent correct on initial consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced an initial consonant on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343072|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables|Measure of percent correct for use of syllables elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct number of syllables on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343073|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand|This is a measure of the child's ability to vocalize on demand elicited by pictures of objects. Scores are derived from the percentage of time the child vocalized for 25 words.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
1343074|NCT01904448|Secondary|MacArthur-Bates Communicative Development Inventories (CDIs) Score|MacArthur-Bates Communicative Development Inventories (CDIs)|Year 3|Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.||||||
1343075|NCT01904448|Secondary|Goldman-Fristoe Test of Articulation Scores (GFTA)|The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.|Year 3|Due to limited progress in spoken language development and test difficulty, this measure was replaced by Identifying Early Phonological Needs in children with hearing loss (IEPN). No data were collected for this measure.||||||
1343076|NCT01904448|Secondary|The Oral and Written Language Scales (OWLS) Oral Expression Score|OWLS-II: Oral Expression measures oral language expression, which is the use of spoken language. The examiner presents a verbal prompt along with a picture and the participant must respond orally to the prompt with increasingly difficult language. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better oral expression. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.|Year 3||||units on a scale|||Number
1343077|NCT01904448|Secondary|The Oral and Written Language Scales (OWLS) Listening Comprehension Score|OWLS-II: Listening Comprehension measures oral language reception, which is the understanding of spoken language. The examiner orally presents increasingly difficult words, phrases, and sentences to the participant and he/she responds by pointing to or stating which of four pictures is correct. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better listening comprehension. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.|Year 3||||units on a scale|||Number
1343079|NCT01904279|Secondary|Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential||Baseline up to Week 52|Safety population.|||percentage of participants|||Number
1343080|NCT01904279|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.|Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52|Safety population. Number Analyzed represents participants evaluable for the specified category.|||millimeters per hour (mm/h)||Standard Deviation|Mean
1343081|NCT01904279|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels||Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52|Safety population. Number Analyzed represents participants evaluable for the specified category.|||mg/L||Standard Deviation|Mean
1343082|NCT01904279|Secondary|Change From Baseline in Soluble IL-6 Receptor Levels||Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52|Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1343083|NCT01904279|Secondary|Change From Baseline in Serum Interleukin-6 (IL-6) Levels|IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.|Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52|Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.|||picograms/milliliter (pg/mL)||Standard Deviation|Mean
1343084|NCT01904279|Primary|Maximum Serum Concentration (Cmax) of TCZ at Steady State|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.|Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population|||mcg/mL||Full Range|Median
1343085|NCT01904279|Primary|Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.|Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population.|||mcg*day/mL||Full Range|Mean
1343086|NCT01904279|Primary|Minimum Serum Concentration (Cmin) of TCZ at Steady State|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.|Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population included all enrolled participants who were adherent to the protocol.|||Micrograms/milliliter (mcg/mL)||Full Range|Median
1343087|NCT01904149|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity – Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population|||percentage of participants|||Number
1343088|NCT01904149|Secondary|SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.~PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population|||units on a scale||Standard Deviation|Mean
1343089|NCT01904149|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief – Verbal Rating Scale: pain relief 0=none, 4=complete) scores.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after first dose|ITT population|||percentage of participants|||Number
1343090|NCT01904149|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|ITT population|||units on a scale||Standard Deviation|Mean
1343091|NCT01904071|Other Pre-specified|Pain Score at 480 Minutes|Pain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|480 minutes|Pain scores were not obtained for 4 patients in the UFNB group, 3 patients in the UFIB group, and 3 patients in the IVMS group at 480 minutes|||units on a scale||Standard Deviation|Mean
1343092|NCT01904071|Other Pre-specified|Pain Score at 240 Minutes|Pain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|240 minutes|Pain score was not obtained for one patient in the UFNB group at 240 minutes|||units on a scale||Standard Deviation|Mean
1343093|NCT01904071|Other Pre-specified|Pain Score at 120 Minutes|Pain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|120 minutes|Pain score was not obtained for one patient in the IVMS group at 120 minutes.|||units on a scale||Standard Deviation|Mean
1343094|NCT01904071|Secondary|Pain Score at 60 Minutes|Pain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|60 minutes||||units on a scale||Standard Deviation|Mean
1343095|NCT01904071|Primary|Pain Score at 30 Minutes|Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|30 minutes||||units on a scale||Standard Deviation|Mean
1343096|NCT01904058|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the product. A serious adverse event (SAE) was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect; an important medical event that did not meet any of the above criteria but jeopardized the participant or required medical or surgical intervention to prevent one of the outcomes listed above. A TEAE was defined as any AE that occurred during the study, from the start of investigational product dosing through the end of the study (13 weeks of treatment period (or ET) + 14 days ]), or that worsened since the start of dosing.|From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)|The Safety Population included all participants who were randomized and received at least 1 dose of the study drug. One participant was randomized to LUM001 10 mg, but was down-titrated to 5 mg dose due to tolerability issues. The safety data has been summarized based on the study dose actually received by the participant.|||participants|||Number
1343097|NCT01904058|Secondary|Change From Baseline in Bile Acid Synthesis as Measured by Serum 7 Alpha-Hydroxy-4-Cholesten-3-One C4 Level [7 Alpha C4]) at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|C4 7 alpha-hydroxy-4-cholesten-3-one is an intermediate in the biochemical synthesis of bile acids from cholesterol and its concentrations reflect the activity of the bile acid synthetic pathway. Elevated levels of C4 indicate bile acid malabsorption. Laboratory C4 levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline Visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1343098|NCT01904058|Secondary|Change From Baseline in Fasting Serum Bile Acid Level at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|Laboratory serum bile acid level levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||micromoles per liter||Standard Deviation|Mean
1343099|NCT01904058|Secondary|Change From Baseline in 5-D Itch Score at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|The 5-D itch (validated instrument to measure pruritus) scale was developed for the multidimensional quantification of pruritus that is sensitive to change over time. The 5-D itch scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
1343100|NCT01904058|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|Laboratory serum ALP enzyme levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units per liter (U/L)||Standard Deviation|Mean
1343101|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Average Daily Scores at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. Adult ItchRO average daily score was the sum of daily scores divided by the number of days adult ItchRO was completed, using the 7 days prior to the reported visit date.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
1343102|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Weekly Sum Scores at Weeks 4, 8 and 13|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline, Weeks 4, 8 and 13|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
1343103|NCT01904058|Primary|Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET)|Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline and Week 13/ET|The mITT population included all participants who were randomized, received at least 1 dose of treatment, and had at least 1 post-baseline ItchRO assessment.|||units on a scale||Standard Deviation|Mean
1343104|NCT01903993|Secondary|DOR (Modified RECIST)|DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only.|||months||95% Confidence Interval|Median
1343105|NCT01903993|Secondary|PFS (Modified RECIST)|PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only|||months||95% Confidence Interval|Median
1343106|NCT01903993|Secondary|ORR (Modified RECIST)|ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only|||percentage of participants||95% Confidence Interval|Number
1343107|NCT01903993|Secondary|Duration of Response (DOR)|DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1343108|NCT01903993|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.|||months||95% Confidence Interval|Median
1343109|NCT01903993|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.|||percentage of participants||95% Confidence Interval|Number
1343110|NCT01903993|Primary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.|||months||95% Confidence Interval|Median
1343111|NCT01903876|Secondary|Sexual Violence Perpetration|This scale is the Conflict Tactics Scale revised, Sexual Coercion Subscale and assessed the number of sexually coercive/violent behaviors engaged in during the past 6 months. The index ranges from 0 (no engagement in any sexual violence) to 7 (engaged in all 7 sexually violent behaviors).|6 months|For some of the variables in this analysis, there were missing data. ANCOVA performed in SPSS will use a listwise deletion. This resulted in n=87 and n=115 for this analysis.|||score on a scale||Standard Error|Mean
1343112|NCT01903876|Primary|Prosocial Intervening Behavior|This scale is the Reactions to Offensive Language and Behavior (ROLB) index that measures whether or not men confronted inappropriate behaviors of other men. We used the 7-item self-behavior subscale plus an additional 8 items, which directly reflected the content of RealConsent. A series of 15 potential intervening situations were presented and participants were asked to indicate whether they had experienced this situation in past 6 months (yes/no), and whether they had intervened (yes/no). The scale ranged from 0% (did not intervene anytime) to 100% (intervened every time).|6 months||||percent score on a scale||Standard Error|Mean
1343120|NCT01903863|Primary|ECMO Pump Longevity|The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours|ECMO course (median 198 hours)||||hours||Inter-Quartile Range|Median
1343121|NCT01903720|Secondary|Percentage of Participants Who Received Laser Treatments|Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.|12 Months|ITT population included all enrolled participants.|||percentage of participants|||Number
1343122|NCT01903720|Secondary|Time to Third Injection|Time in weeks from the second injection to the third injection.|12 Months|ITT population included all enrolled participants.|||weeks||Standard Deviation|Mean
1343123|NCT01903720|Secondary|Time to Second Injection|Time in weeks from the first injection to the second injection.|12 Months|ITT population included all enrolled participants.|||weeks||Standard Deviation|Mean
1343124|NCT01903720|Secondary|Percentage of Participants Receiving a Third Injection||12 Months|ITT population included all enrolled participants.|||percentage of participants|||Number
1343125|NCT01903720|Secondary|Percentage of Participants Receiving a Second Injection||12 Months|ITT population included all enrolled participants.|||percentage of participants|||Number
1343126|NCT01903720|Secondary|Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.|Baseline, Months 6 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."|||percentage of participants|||Number
1343127|NCT01903720|Secondary|Change From Baseline in CRT at Each Visit|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."|||micrometers (μm)||Standard Deviation|Mean
1343128|NCT01903720|Secondary|Change From Baseline in BCVA at Each Visit|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."|||letters||Standard Deviation|Mean
1343129|NCT01903720|Secondary|Change From Baseline in CRT at Month 12|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||μm||Standard Deviation|Mean
1343130|NCT01903720|Secondary|Change From Baseline in BCVA at Month 12|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||letters||Standard Deviation|Mean
1343131|NCT01903720|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Month 6|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 6|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||micrometers (μm)||Standard Deviation|Mean
1343132|NCT01903720|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 6|"Intent-to-treat (ITT) population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||letters||Standard Deviation|Mean
1343133|NCT01903564|Secondary|Percentage of Fetuses With a Family History of Long QT Syndrome Who Had a Change in Management Due to fMCG|Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG|15 weeks' gestation to birth|Fetuses with a family history of fetal long QT syndrome|||Participants|||Count of Participants
1343134|NCT01903564|Secondary|Percentage of Fetuses With a Family History of Long QT Syndrome Who a Change in Diagnosis Due to fMCG|Percentage of fetuses with a family history of long QT syndrome who a change in diagnosis due to fMCG|15 weeks' gestation to birth|Fetuses with family history of LQTS|||Participants|||Count of Participants
1343135|NCT01903564|Primary|Percentage of Subjects Experiencing Adverse Events Related to Device|Percentage of Subjects Experiencing Adverse Events Related to Device|15 weeks' gestation till up to 1 month after birth||||Participants|||Count of Participants
1343136|NCT01903564|Primary|Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome|Number of Participants with Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome based on measurement of rate-corrected QT interval (QTc)|Birth to age 1 week|Fetuses with a family history of long QT syndrome|||Participants|||Count of Participants
1343137|NCT01903564|Primary|Percentage of Subjects Experiencing Adverse Events Unrelated to Device|Percentage of subjects experiencing adverse events unrelated to device|15 weeks' gestation till up to 1 month after birth||||Participants|||Count of Participants
1343138|NCT01903564|Primary|Percentage of Subjects Experiencing Symptoms|Percentage of subjects experiencing symptoms|15-40 weeks' gestation|Symptoms include premature labor, vaginal bleeding, uterine cramping, nausea/vomiting, dizziness, dsypnea, syncope, palpitations, or fatigue during the study session.|||Participants|||Count of Participants
1343139|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Pruritus as Measured by The Patient And Observer Itch Reported Outcome (ItchRO) Average Daily Scores|The ItchRO was administered as a twice daily electronic diary (eDiary). Children ≥9 years of age completed the patient ItchRO; those between the ages of 5 and 8 completed the patient ItchRO with the assistance of their caregiver. There was no patient report for subjects under the age of 5. ItchRO scores range from 0 to 4, with the higher score indicating increasing itch severity. ItchRO average daily scores were calculated as the sum of daily scores (ie, the maximum of morning and evening scores) divided by the number of days. The average daily score was calculated by using the 7 days pre-treatment for baseline, and the last 7 days of treatment for Week 13. A negative change from Baseline indicates that itch severity decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.|||units on a scale||Standard Error|Least Squares Mean
1343140|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Liver Enzymes|Analysis of liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP). A negative change from baseline indicates that the level of that enzyme decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.|||U/L||Standard Error|Least Squares Mean
1343141|NCT01903460|Primary|Change From Baseline to Week 13 (End of Treatment) in Fasting Serum Bile Acid Level|Participants were required to fast for at least 4 hours; only water was permitted prior to collection. A negative change from baseline indicates that the level of bile acid decreased.|Baseline to 13 weeks or end of treatment|The modified Intent-to-Treat (mITT) population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.|||umol/L||Standard Error|Least Squares Mean
1343142|NCT01903265|Secondary|Change From Baseline to Week 12 in FIQ-R Total Score|"The Fibromyalgia Impact Questionnaire (revised) FIQ-R is made up of 3 domains: functional (9 questions), overall (2 questions) and symptoms (10 questions). All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being worst. Total FIQ-R scores can range from 0-100, with higher scores reflecting worsening status. The patient's total score on the FIQ-R was assessed at Visits 2, 3, 4, 5, and 6 (Week 12). Jump to control was used to replace missing data in each treatment arm."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||units on a scale||Standard Error|Least Squares Mean
1343143|NCT01903265|Secondary|Patient Global Impression of Change (PGIC) Responder Status (“Very Much Improved” or “Much Improved” vs All Other Categories) at Week 12|The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study. Scores of 1 and 2 were considered responders.|Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||percentage of participants|||Number
1343144|NCT01903265|Secondary|Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance|The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||units on a scale||Standard Error|Least Squares Mean
1343145|NCT01903265|Secondary|30% Responder Analysis of IVRS NRS Pain Assessments at Week 12|"The weekly averages of daily pain scores were calculated using the daily, 24-hour-recall, IVRS NRS pain assessments.~Patients who had at least a 30% improvement from baseline to week 12 in weekly average of daily pain scores were considered responders."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients.|||percentage of participants|||Number
1343146|NCT01903265|Primary|Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12|Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||units on a scale||Standard Error|Least Squares Mean
1343147|NCT01903252|Secondary|Period 3: UC-Related Complications|Percentage of Patients with Complications related to UC|Week 38|Intent to Treat|||Participants|||Count of Participants
1343148|NCT01903252|Secondary|Period 3: No Urgency|No urgency is a score of 0 and indicates that patients did not report urgency during any of the three days prior to the visit at week 38. A score of 1 indicates that urgency was reported during any of these three days.|Week 38|Intent to Treat|||Participants|||Count of Participants
1343149|NCT01903252|Secondary|Period 3: Stool Frequency Sub-score 0|Patients achieving a Stool Frequency sub-score of 0|Week 38|Intent to Treat|||Participants|||Count of Participants
1343150|NCT01903252|Secondary|Period 3: Rectal Bleeding Sub Score of 0|Percentage of each dose group achieving the endpoint rectal bleeding subscore 0|Week 38|Intent to Treat|||percentage of participants|||Number
1343151|NCT01903252|Secondary|Period 3: Endoscopic Response|Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.|Week 38|Intent to Treat|||percentage of participants|||Number
1343153|NCT01903252|Secondary|Period 3: Clinical and Endoscopic Response|Both has to be achieved, Clinical and Endoscopic Response which is defined by a decrease from baseline in the Mayo score of ≥ 3 points and > 30% of the baseline score, with an accompanying decrease in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of 0 or 1.|Week 38|Intent to Treat|||percentage of participants|||Number
1343154|NCT01903252|Secondary|Period 3: Clinical and Endoscopic Remission|Mayo Score of <= 2 points with no individual sub-score > 1|Week 38|Intent to Treat|||percentage of participants|||Number
1343155|NCT01903252|Secondary|Period 3: Clinical Response|A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 38|Intent to Treat|||percentage of participants|||Number
1343156|NCT01903252|Secondary|Period 2: UC-Related Complications|Percentage of Patients Experiencing Complications related to UC|Week 16|Intent to Treat|||Participants|||Count of Participants
1343157|NCT01903252|Secondary|Period 2: Urgency|Percentage of patients achieving an Urgency Score of 0. A score of 0 indicates no urgency reported in any of the three days prior to the visit at week 16. A score of 1 indicates urgency reported in any of the three days prior to the visits.|Week 16|Indent to Treat|||Participants|||Count of Participants
1343158|NCT01903252|Secondary|Period 2: Stool Frequency 0|Percentage of patients achieving the endpoint stool frequency sub-score of 0|Week 16|Intent to Treat|||Participants|||Count of Participants
1343159|NCT01903252|Secondary|Period 2: Rectal Bleeding Sub-score of 0|Percentage of patients achieving the endpoint rectal bleeding sub-score of 0|Week 16|Intent to treat|||Participants|||Count of Participants
1343160|NCT01903252|Secondary|Period 2: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 16|Intent to Treat|||Participants|||Count of Participants
1343161|NCT01903252|Secondary|Period 1: Change in Endoscopic Score From Baseline|Between-Group Difference of Endoscopic Score, Change from Baseline. The changes from baseline to week 8 values in sigmoidoscopic (mucosal) appearance scores will be compared between the two treatment groups. A value of 0 in the endoscopic score means normal or inactive disease and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
1343162|NCT01903252|Secondary|Period 1: Change in Physician Global Assessment Score From Baseline|"Between-Group Difference of Physician Global Assessment Score, Change from Baseline.~The changes from baseline to week 8 values in the Physician Global Assessment score will be compared between the two treatment groups. A value of 0 means no pathology and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success."|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
1343163|NCT01903252|Secondary|Period 1: Change in Rectal Bleeding Score From Baseline|Between-Group Difference of Rectal Bleeding Score, Change from Baseline The changes from baseline to week 8 values in rectal bleeding scores will be compared between the two treatment groups. A value of 0 indicates no rectal bleeding, a value of 3 indicates only blood is passing. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference at week 8 compared to baseline is indicative of treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
1343164|NCT01903252|Secondary|Period 1: Change in Stool Frequency Score|Between-Group Difference of Stool Frequency Score, Change from Baseline The changes from baseline to week 8 values in stool frequency will be compared between the two treatment groups. Values for stool frequency range between 0 and 3. A value of 0 indicates normal stool frequency, a value of 3 indicates 5 or more stools than normal. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between week 8 values and baselines indicates treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
1343165|NCT01903252|Secondary|Period 1: Change in Partial Mayo Score From Baseline|Between-Group Difference of Partial Mayo Score, Change from Baseline to Week 8 The Partial Mayo Score is the sum of the component sub-scores, 1) stool frequency, 2) rectal bleeding and 3) physician’s global assessment. A partial Mayo Score of 0 indicates no disease and a maximum score of 9 indicates severe symptoms. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Partial Mayo Score from Baseline where patients experienced acute disease, indicates improvement and treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
1343166|NCT01903252|Secondary|Period 1: Change in Mayo Score From Baseline|"Between-Group Difference of Mayo Score, Change from Baseline The changes from baseline to week 8 values in Mayo scores are compared between the two treatment groups.~The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each scored on a scale ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores consist of, 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician’s global assessment. A Mayo score of 0 indicates no pathology and a score of 12, severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Mayo score from baseline when patients experienced acute disease, indicates improvement and treatment success."|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
1343167|NCT01903252|Secondary|Period 1: Clinical Response at Both Week 8 and Week 12|A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 8 and Week 12|Per Protocol|||Participants|||Count of Participants
1343168|NCT01903252|Secondary|Period 1: Clinical Remission at Both Week 8 and 12|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 8 and week 12|Per Protocol|||Participants|||Count of Participants
1343169|NCT01903252|Secondary|Period 1: Rectal Bleeding Score of 0|Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score|Week 12|Per Protocol|||Participants|||Count of Participants
1343170|NCT01903252|Secondary|Period 1: Clinical Response|A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 12|Per protocol|||Participants|||Count of Participants
1343171|NCT01903252|Secondary|Period 1: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 12|Per Protocol|||Participants|||Count of Participants
1343172|NCT01903252|Secondary|Period 1: Clinical and Endoscopic Response|Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder.|Week 8|Per Protocol|||Participants|||Count of Participants
1343173|NCT01903252|Secondary|Period 1: Rectal Bleeding Sub-score of 0|Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score|Week 8|Per Protocol|||Participants|||Count of Participants
1343174|NCT01903252|Secondary|Period 1: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 8|Per Protocol|||Participants|||Count of Participants
1343175|NCT01903252|Secondary|Period 1: Endoscopic Response|Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.|Week 8|Per Protocol|||Participants|||Count of Participants
1343176|NCT01903252|Secondary|Period 1: Endoscopic Remission|Endoscopic remission was defined as a Mayo endoscopy subscore of 0|Week 8|Per Protocol|||Participants|||Count of Participants
1343177|NCT01903252|Primary|Period 3: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 38|Intent to Treat|||percentage of participant|||Number
1343178|NCT01903252|Primary|Period 2: Clinical Response, Open-Label Extended Induction|A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 16|Intent to Treat|||Participants|||Count of Participants
1343179|NCT01903252|Primary|Period 1: Clinical and Endoscopic Remission|Mayo Score of <= 2 points with no individual sub-score > 1|Week 8|Per Protocol|||Participants|||Count of Participants
1343180|NCT01903187|Secondary|Reduction in Ambulatory Blood Pressure (ABP) Parameters|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|baseline, 6 months post randomization, and all follow-up timepoints|All subjects|||mmHg||Standard Deviation|Mean
1343181|NCT01903187|Secondary|Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization, and all follow-up timepoints|Subjects who received renal denervation|||Participants|||Count of Participants
1343182|NCT01903187|Secondary|The Number of Subjects That Experience Each Type of MAE|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization|Subjects who received renal denervation|||Participants|||Count of Participants
1343183|NCT01903187|Secondary|Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization|Subjects who received renal denervation|||Participants|||Count of Participants
1343184|NCT01903187|Primary|The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups||6 months post randomization|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct a comparison between groups.|||mmHg||Standard Deviation|Mean
1343185|NCT01903187|Primary|The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.|6 months post randomization|All subjects randomized to the EnligHTN procedure|||percentage of participants|||Number
1343186|NCT01903148|Secondary|Patients With Hb<11||1 day||||participants|||Number
1343187|NCT01903148|Secondary|Iron Treatment|Patients with supplementary Iron treatment to ESA|1 day||||participants|||Number
1343188|NCT01903148|Secondary|% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy|know the treatments ESA for maintenance of hb levels|1 day||||percentage of participants|||Number
1343189|NCT01903148|Secondary|Patients With Hb>12||1 day||||participants|||Number
1343190|NCT01903148|Secondary|Hemoglobin Levels Per Type of Patients|levels Hb and type of patients|1 day|n represents the number of participants analyzed for each category respectively (converted patients, naïve patients)|||mg/dl||Standard Deviation|Mean
1343191|NCT01903148|Primary|% Patients Achieving Target Hemoglobin Levels|% patients with Hb levels between 11-12 mg/dl|1 day because is a crosssectional study with only a visit||||percentage of participants|||Number
1343210|NCT01903031|Secondary|Etonogestrel Concentrations Obtained on Study Days 7 and 14|This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL).|Study days 7 and 14|Participants who provided the Etonogestrel PK samples at day 7 and at day 14 were included in the analysis.|||pg/mL||Full Range|Median
1343192|NCT01903031|Secondary|Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.|This evaluates alterations in progesterone levels due to the potential PK interaction between NuvaRing and the ARVs EFV and ATV/r by examining progesterone levels at study days 0 (before vaginal ring placement), 7, 14, and 21 (before vaginal ring removal), and study day 28, without regard to menstrual cycle status at study entry.|Study days 0, 7, 14, 21 and 28|All participants included in the primary analyses who had progesterone data available. One participant on the EFV arm is excluded at day 14 visit because NuvaRing was out of the body for >3 hours leading up to the visit.|||proportion of participants||95% Confidence Interval|Number
1343193|NCT01903031|Secondary|Percentage of Participants With Signs and Symptoms of Grade 2 or Higher Deemed Possibly, Probably or Definitely Related to Study Treatment|This evaluates toxicity and safety of NuvaRing alone, NuvaRing with EFV, and NuvaRing with ATV/r. Signs/symptoms were graded using the DAIDS AE Grading Table was used. Participants with sign(s)/symptom(s) of grade 2 (moderate), 3 (severe), 4 (potentially life-threatening) or 5 (death) are included in the percentage. Relationship to study treatment was determined by the study co-chairs and DAIDS clinical representative.|From day 0 to day 28|All participants in whom NuvaRing was inserted|||Percent of Participants|||Number
1343194|NCT01903031|Secondary|Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL|This evaluates the short-term impact of Nuvaring on virologic suppression in participants who have been administered Nuvaring alone or together with EFV or ATV/r by measuring proportion of participants with plasma HIV-1 RNA levels <40 copies/mL at study day 0 (before vaginal ring placement) and study day 21 (three weeks after vaginal ring placement). An FDA-approved HIV-1 RNA assay was required.|Study day 0 and study day 21|All participants in whom NuvaRing was inserted and with HIV-1 RNA data available.|||proportion of participants||95% Confidence Interval|Number
1343195|NCT01903031|Secondary|RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter CLss/F of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||hour||Full Range|Median
1343196|NCT01903031|Secondary|RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter Tmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||hour||Full Range|Median
1343197|NCT01903031|Secondary|RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter Cmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||ng/mL||Full Range|Median
1343198|NCT01903031|Secondary|RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter Cmin of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||ng/mL||Full Range|Median
1343199|NCT01903031|Secondary|Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h).|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||h*ng/mL||Full Range|Median
1343200|NCT01903031|Secondary|ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/f defines apparent oral clearance.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||L/h||Full Range|Median
1343211|NCT01903031|Primary|Ethinyl Estradiol Concentrations at Study Day 21|This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 21 days after NuvaRing administration. The PK blood sample for measurement of ethinyl estradiol on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL ; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL).|Day 21|Participants who provided the Ethinyl Estradiol PK sample at day 21 were included in the analysis.|||pg/mL||Full Range|Median
1343201|NCT01903031|Secondary|ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter Tmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||hour||Full Range|Median
1343202|NCT01903031|Secondary|ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||ng/mL||Full Range|Median
1343203|NCT01903031|Secondary|ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||ng/mL||Full Range|Median
1343204|NCT01903031|Secondary|ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of ATV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h).|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||h*ng/mL||Full Range|Median
1343205|NCT01903031|Secondary|EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the EFV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||L/h||Full Range|Median
1343206|NCT01903031|Secondary|EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the EFV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||ng/mL||Full Range|Median
1343207|NCT01903031|Secondary|EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the EFV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||ng/mL||Full Range|Median
1343208|NCT01903031|Secondary|EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of EFV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h).|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||h*ng/mL||Full Range|Median
1343209|NCT01903031|Secondary|Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.|This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL).|Study days 7 and 14|Participants who provided the Ethinyl estradiol PK samples at day 7 and at day 14 were included in the analysis.|||pg/mL||Full Range|Median
1343508|NCT01897077|Secondary|The Rate of Medication Use With Therapy|For peanut allergic subjects only.|18 months|No participants were analyzed for this secondary outcome because no data for the outcome was collected due to early termination of the study||||||
1343212|NCT01903031|Primary|Etonogestrel Concentrations at Study Day 21|This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL).|Day 21|Participants who provided the Etonogestrel PK sample at day 21 were included in the analysis.|||pg/mL||Full Range|Median
1343213|NCT01903005|Primary|Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events|Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population|||participants|||Number
1343214|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Serious Adverse Events|Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 throught week 24|Safety population|||participants|||Number
1343215|NCT01903005|Primary|Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events|Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population|||participants|||Number
1343216|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Adverse Events|Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population|||participants|||Number
1343217|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||units on a scale||95% Confidence Interval|Mean
1343218|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||hours||95% Confidence Interval|Mean
1343219|NCT01903005|Secondary|Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)|"Question 1 of the WPAI:SHP asks patients to provide a yes or no response to the question Are you employed?; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end"|Study Endpoint|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed|||percentage of patients|||Number
1343220|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores|"Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 (no cravings) to 100 mm (most intense craving I have ever had); study endpoint was defined as the last post-baseline value recorded for VAS craving"|Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data|||units on a scale||95% Confidence Interval|Mean
1343221|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score|Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data|||units on a scale||95% Confidence Interval|Mean
1343222|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score|Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint|Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data|||units on a scale||95% Confidence Interval|Mean
1343223|NCT01903005|Secondary|Retention in Treatment in the Safety Population|Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)|Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24|Safety population|||participants||95% Confidence Interval|Number
1343224|NCT01902888|Primary|Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.|30 day serious adverse events related to the initial study procedure or the study device.|30 days following initial study procedure|||||||
1343225|NCT01902888|Primary|Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.|A composite of freedom from failure of technical success or loss of primary patency at 12 months|12 months following initial study procedure|||||||
1343226|NCT01902758|Primary|Time (Minutes) to Complete 2 Miles on a Treadmill||after arriving at high altitude (within 1 hour)||||seconds||Standard Deviation|Mean
1343227|NCT01902628|Secondary|Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Up to 10 months|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.|||Participants|||Count of Participants
1343228|NCT01902628|Secondary|Percentage of Participants With MIRCERA Dose Adjustments|Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.|Up to 10 months|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. Number analyzed indicates number of participants evaluated at specific time points.|||percentage of participants|||Number
1343229|NCT01902628|Secondary|Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10|g/dL = grams per deciliter|Months 8 to 10|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.|||percentage of participants|||Number
1343230|NCT01902628|Primary|Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10|g/dL = grams per deciliter|Months 8 to 10|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.|||percentage of participants|||Number
1343231|NCT01902459|Other Pre-specified|This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.|This product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation.|Intraoperative||||Participants|||Number
1343232|NCT01902459|Other Pre-specified|This Product is Easy to Apply to a Variety of Bleeding Sites.|This product is easy to apply to a variety of bleeding sites.|Intraoperative||||Participants|||Number
1343233|NCT01902459|Other Pre-specified|This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.|This product is easy and quick to prepare for application to the target bleeding site.|Intraoperative||||Participants|||Number
1343234|NCT01902459|Primary|Safety Parameter - Incidence of Increase Blood Fibrinogen Level|Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.|Surgery up until the 30 day follow-up||||Participants|||Number
1343235|NCT01902459|Primary|Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)|Number of subjects experiencing a post-operative bleeding event specifically related to the target bleeding site (TBS) and as reported in the adverse events/serious adverse event safety set. Safety set consisting of all subjects on whom procedure is started.|Surgery up until the 30 day follow-up||||Participants|||Number
1343236|NCT01902459|Primary|Safety Parameter - Incidence of Thromboembolic Events|Number of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started.|Surgery up until the 30 day follow-up||||Participants|||Number
1343237|NCT01902303|Secondary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant|The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered “aborted” or “blocked”. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.|0 -7 days|158 subjects randomized to treatment. 118 subjects used allocated assigned treatment (62 test article and 56 placebo). 7 subjects failed to complete and 111 completed study. For this secondary analysis (self assessments) 53 subjects noted prodrome occurring on Day 0.|||participants with aborted lesions|||Number
1343238|NCT01902303|Primary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator|The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered “aborted” or “blocked”. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.|Day 0- Day 7|Participants that did not experience prodrome stage as assessed by the evaluator or met major protocol violations were not included in the PP analysis.|||participants who had aborted lesions|||Number
1343239|NCT01902134|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief – Verbal Rating Scale: pain relief 0=none, 4=complete) scores.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose||||percentage of participants|||Number
1343240|NCT01902134|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity – Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase||||percentage of participants|||Number
1343299|NCT01900665|Secondary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)|The vMRI assessment of right and left hippocampal atrophy, is reported. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
1343241|NCT01902134|Secondary|SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.~PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase||||units on a scale||Standard Deviation|Mean
1343242|NCT01902134|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose||||units on a scale||Standard Deviation|Mean
1343243|NCT01901809|Primary|Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine|Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy|72 hours||||percent change in serum creatinine||95% Confidence Interval|Mean
1343244|NCT01901809|Primary|Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic|Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by diuretic strategy|72 hours||||percent change in serum creatinine||95% Confidence Interval|Mean
1343245|NCT01901809|Primary|Percent Change in Serum Creatinine at 72 Hours.|Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.|72 hours||||percent change in serum creatinine||Standard Deviation|Mean
1343246|NCT01901653|Secondary|Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC|The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum.|From Day 1 of first dose to End of Dose Cycle|All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.|||μg•d/mL||Geometric Coefficient of Variation|Geometric Mean
1343247|NCT01901653|Secondary|Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC)|The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle.|From Day 1 of first dose to End of Dose Cycle|All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1343248|NCT01901653|Secondary|Overall Survival|Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive.|From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months).|Subjects with at least one post-dose assessment.|||months||95% Confidence Interval|Median
1343249|NCT01901653|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study.~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months).|Subjects with at least one post-dose assessment.|||months||95% Confidence Interval|Median
1343250|NCT01901653|Secondary|Clinical Benefit Rate (CBR)|"Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders.~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months).|Subjects with at least one post-dose assessment.|||percentage of subjects||95% Confidence Interval|Number
1343251|NCT01901653|Secondary|Duration of Response (DOR)|"Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first.~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months).|Subjects with at least one post-dose assessment. No LCNEC subjects achieved CR or PR, therefore DOR was not analyzed.|||months||95% Confidence Interval|Median
1343268|NCT01901341|Other Pre-specified|Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.|||participants|||Number
1343300|NCT01900665|Secondary|Change From Baseline in Plasma Amyloid-Beta (Aβ) Species|Concentration of amino acid peptide known as Aβ 1-42 in plasma. The change in plasma Aβ analytes after treatment were assessed separately for each plasma Aβ parameter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants.|||Picogram/milliliter||Standard Error|Least Squares Mean
1343252|NCT01901653|Secondary|Objective Response Rate (ORR)|"Overall response was assessed at each visit post-baseline based on a subject’s lesion measurements or assessments (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR).~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months).|Subjects with at least one post-dose assessment. All LCNEC subjects were analyzed. No LCNEC subjects achieved CR or PR and, therefore, the ORR was 0%.|||percentage of subjects||95% Confidence Interval|Number
1343253|NCT01901653|Primary|Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine|MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT).|The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.|All subjects from Phase 1a Dose Escalation: Cohort 1 to 8 who received at least 1 dose of study drug.|||mg/kg|||Number
1343254|NCT01901588|Secondary|Time to PACU Discharge||Length of PACU stay (around 3 hours on average)||||minutes||Standard Deviation|Mean
1343255|NCT01901588|Secondary|Time to Arousal||Length of PACU stay (around 3 hours on average)||||minutes||Standard Deviation|Mean
1343256|NCT01901588|Secondary|Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications||Length of PACU stay (around 3 hours on average)||||percentage of participants|||Number
1343257|NCT01901588|Secondary|Post-op Pain Interventions||Length of PACU stay (around 3 hours on average)||||number of pain interventions/group|||Number
1343258|NCT01901588|Secondary|Percentage of Participants Receiving Pain Medication||Length of PACU stay (around 3 hours on average)||||percentage of participants|||Number
1343259|NCT01901588|Primary|Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery||Length of PACU stay (around 3 hours on average)||||percentage of participants|||Number
1343260|NCT01901575|Primary|PVC Suppression With Remifentanil Sedation|1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression|duration of the operative procedure, average 2 hours||||participants with PVC suppression|||Number
1343261|NCT01901575|Primary|Inhibition of Idiopathic Ventricular Tachycardia|"observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's.~Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation."|duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours|Study Data impacted by Storm Sandy in NYC and data lost for reporting||||||
1343262|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity With Movement)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure|||units on a scale (in mm)||Standard Deviation|Mean
1343263|NCT01901393|Secondary|Incidence of Serious Adverse Events|Number of subjects experiencing treatment-emergent serious adverse events|Post-operative period until discharge, an expected average of 6 hours||||Number of events|||Number
1343264|NCT01901393|Secondary|Patient Satisfaction|Measured using 2 question, 4 point scale.|Post-operative period until discharge, an expected average of 6 hours||||Participants|||Number
1343265|NCT01901393|Secondary|Time to First Use of Rescue Med Will be Measured|Time to first rescue medication (in hours) in the postoperative period through discharge.|Post-operative period until discharge, an expected average of 6 hours||||hours||Standard Error|Mean
1343266|NCT01901393|Secondary|Rescue Medication Use in Post-operative Period|Amount of rescue medication (in milligrams) will be measured|Post-operative period until discharge, an expected average of 6 hours||||milligrams||Standard Deviation|Mean
1343267|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity at Rest)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure|||units on a scale (in mm)||Standard Deviation|Mean
1343269|NCT01901341|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343270|NCT01901341|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343271|NCT01901341|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at the 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343272|NCT01901328|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks||||participants|||Number
1343273|NCT01901328|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343274|NCT01901328|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343275|NCT01901328|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343276|NCT01901302|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.|||participants|||Number
1343277|NCT01901302|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343278|NCT01901302|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (“did not experience”) to 4 (“very severe”).|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343279|NCT01901302|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks|"A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week.~For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12)."|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
1343280|NCT01901289|Primary|Number of Lesions Without Target Lesion Revascularization (TLR)|A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.|1 year|All lesions with information through 12-months. The result was calculated using the Kaplan-Meier method (with Greenwood's formula for standard error).|||Lesions|Lesions||Count of Units
1343915|NCT01890577|Secondary|Hemoglobin Within the Range 10-12 g/dL Over Time|Due to the premature termination of the study no outcome measure data were analyzed.|On a continuous basis over the 15-month observation period|||||||
1343281|NCT01901250|Primary|Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade|"The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.~For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the D and F portions of DFT, respectively."|baseline and middle of 2nd grade||||Number of surfaces||Standard Deviation|Mean
1343282|NCT01901211|Secondary|Anthropometric Measurements (Weight)|Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||Kg||Standard Deviation|Mean
1343283|NCT01901211|Secondary|StepWatch Activity Monitors|StepWatch Activity Monitors will be used to measure activity levels and motor participation. The StepWatch is a two-plane accelerometer that is worn around the ankle in a knit cuff. The StepWatch measures ambulatory activity (i.e. total daily step count) and acts as an indicator of motor participation in the community.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||Steps/day||Standard Deviation|Mean
1343284|NCT01901211|Secondary|Gaming Data|"Gaming data will be collected as measures of effectiveness of the games' balancing techniques, engagement and adherence. The games will be instrumented to automatically collect usage data including: amount of time playing; amount of time within HR zones while playing.~Higher numbers indicate more activity and more time above 40% hear rate reserve (HRR) while playing."|10-weeks of the exergaming intervention||||minutes||Standard Deviation|Mean
1343285|NCT01901211|Secondary|The Self-Worth Domain of the KINDL-R Questionnaire|"The 4-item Self-worth Domain of the KINDL-R will be used as an indicator of self-esteem.~The subscale has 4 items scored on a five-point Likert scale that can be scored in isolation and is converted to percent of total subscale score. Higher scores indicate greater self-worth."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||percentage of total subscale score||Standard Deviation|Mean
1343286|NCT01901211|Secondary|Total Score of the KINDL-R Questionnaire|"The total score of the 24-item KINDL-R questionnaire will measure the participants' health-related quality of life.~Scores are on a five-point Likert scale that can be scored in isolation and is converted to percent of total score. Total score is the summed score divided by the number of items (24).~Higher scores indicate greater health related quality of life."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||percentage of total score on a scale||Standard Deviation|Mean
1343287|NCT01901211|Secondary|Anthropometric Measurements|Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, will be used to assess body composition as indicators of physical fitness.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||cm||Standard Deviation|Mean
1343288|NCT01901211|Secondary|The 30-second Wingate Cycle Test|"The 30-second Wingate Cycle Test is a measure of anaerobic power, a key component of physical fitness. The cycle test is performed when a participant uses a cycle ergometer and pedals as hard as they can for 30-seconds against a constant braking force.~The measure is relative peak power (watts/kg) normalized to body weight. Higher scores indicate greater anaerobic power."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|This test was unsuitable for over half the participants, who were unable to complete one or more of the 30-second Wingate tests. Malfunctioning equipment also made collecting full data sets impossible.|||Watts/Kg||Standard Deviation|Mean
1343289|NCT01901211|Secondary|Handheld Dynamometry Measures of Knee Flexors and Knee Extensors|"Handheld dynamometry will be used to measure muscle strength for the quadriceps muscles and the hamstrings at 90˚ of knee flexion in both legs.~The individual sits with legs at 90˚ of knee flexion and resistance will be given anteriorly (knee extensors) and posteriorly (knee flexors) two inches proximal to the lateral malleoli.~Higher score indicates greater strength."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||pounds||Standard Deviation|Mean
1343298|NCT01900665|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)|Area Under the Concentration versus Time Curve was evaluated for Solanezumab.|Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion|All randomized participants who received at least 1 dose of study medication (Solanezumab) with evaluable Solanezumab PK data.|||milligram*hour per milliliter (mg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1353782|NCT01749956|Secondary|Sphincter Preservation Rate|The percentage of patients who had Low Anterior Resection during surgery..|Between days 57 and 98 after preoperative chemotherapy.||||percentage of patients|||Number
1343290|NCT01901211|Primary|Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire|"Wellbeing Related to Friends/Peers domain of the KINDL-R is a four-item subscale focusing on time spent with friends, being perceived as a success with friends, getting along with friends and whether or not they felt different from peers over the past week.~The subscale has 4 items scored on a five-point Likert scale that can be scored in isolation and is converted to percent of total subscale score. Higher scores indicate greater social wellbeing."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||percentage of total subscale score||Standard Deviation|Mean
1343291|NCT01901211|Primary|Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)|The 7.5m Shuttle Run test (SRT-III) is a maximal, running-based, field test that can assess cardiovascular fitness in children with CP GMFCS level III. In the tests, markers are placed 7.5m apart in a square formation. Participants walk from marker to marker according to progressively faster auditory cues from a music device. The assessment is scored by the total number of shuttle run levels that the participant completes to the nearest half shuttle. A higher score is better.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||units on a scale||Standard Deviation|Mean
1343292|NCT01901185|Other Pre-specified|Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study. The definition includes worsening of a pre-existing medical condition. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. An adverse device effect is any adverse event related to the use of a medical device. Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.|9 weeks|Safety population|||participants|||Number
1343293|NCT01901185|Secondary|Percentage of Errors in Each Step of the Self-injection Process|For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported. If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not. • Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.|||percentage of errors|Participants||Number
1343294|NCT01901185|Secondary|Percentage of Autoinjector A System Failures|The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers. System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.|||percentage of system failures|Participants|95% Confidence Interval|Number
1343295|NCT01901185|Primary|Percentage of Successful Self-injections to Total Non-missed Injections|The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set defined as all nonmissed injections using Autoinjector A during Weeks 1 to 5 for all enrolled participants; in the event of multiple injection attempts, only the last attempt per week was counted.|||percentage of successful injections|Participants|95% Confidence Interval|Number
1343296|NCT01900665|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels|Concentration of CSF parameters includes amino acid peptide known as Aβ 1-42 and Aβ 1-42. Analyses of these CSF biomarkers was conducted in a subset of participants (as an addendum to the protocol). The dependent variable for each CSF parameter was its change from baseline to endpoint. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||picogram/milliliter||Standard Error|Least Squares Mean
1343297|NCT01900665|Secondary|Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan|Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||standard uptake value ratio||Standard Error|Least Squares Mean
1343301|NCT01900665|Secondary|Percentage of Participants of Cognitive and Functional Responders|Assess the proportion of participants who reach certain levels of cognitive and functional decline. Decline in cognition was defined as worsening from baseline by at least 6 or 9 points on the ADAS Cog14. If there is a cognitive decline of a specified cut-off or more at any time then the participant is considered a nonresponder. Functional nonresponders are participants who have not had any of the following at any time point: Clinically evident decline in ability to perform one or more basic ADL present at baseline; A clinically evident decline in ability to perform 20% or more of the instrumental ADL present at baseline; An increase in global CDR score of 1 point or more compared with baseline. A decline from no impairment to mild impairment (bADL, iADL is not considered clinically significant, but other declines of 1 or more points and any participant discontinuation within the first 6 months will be considered a non-responder.|Baseline through Week 80|All randomized participants.|||percentage of participants|||Number
1343302|NCT01900665|Secondary|Change From Baseline in Integrated Alzheimer’s Disease Rating Scale (iADRS)|Integrated Alzheimer’s Disease Rating Scale is used to assess that solanezumab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of ADAS-Cog 13 or 14 and the ADCS-iADL. The scale ranges from 0 to 146, where lower scores indicate worse performance. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||units on a scale||Standard Error|Least Squares Mean
1343303|NCT01900665|Secondary|Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. Visual analog scale (VAS) assesses caregiver's impression of participant's health state; score ranges: 0 to 100 millimeter (mm). Lower scores=greater disease severity LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||mm||Standard Error|Least Squares Mean
1343304|NCT01900665|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)|Assesses QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant’s primary caregiver asked to complete same measure. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343305|NCT01900665|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Number of hospitalizations||Standard Error|Least Squares Mean
1343306|NCT01900665|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI)|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343307|NCT01900665|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Deviation|Mean
1343308|NCT01900665|Secondary|Change From Baseline in Functional Activities Questionnaire (FAQ)|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant’s ability to perform a variety of activities ranging from financial management, shopping, playing games, food preparation, traveling, keeping appointments, keeping track of current events, and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome). LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343309|NCT01900665|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343320|NCT01900652|Secondary|Duration of Response (DoR)|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.|Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.||||||
1343310|NCT01900665|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343311|NCT01900665|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)|The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343312|NCT01900665|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343313|NCT01900665|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)|The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 14 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
1343314|NCT01900652|Secondary|Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response||Baseline through 30-Day Follow-Up (Up to 24 Months)|All participants who received at least one dose of study drug and have sufficient Anti-Emibetuzumab Antibody sample for the analysis.|||participants|||Number
1343315|NCT01900652|Secondary|Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab|AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.|Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion|All participants who received Emibetuzumab on Cycle 1, Day 1, and contributed samples for analysis.|||Microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1343316|NCT01900652|Secondary|Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)|"The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.~Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state)."|Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)|All randomized participants with EQ-5D values at baseline.|||units on a scale||Standard Deviation|Mean
1343317|NCT01900652|Secondary|Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)|The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. The higher scores represent a greater degree of symptoms.|Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)|All randomized participants with EORTC QLQ-LC13 values at baseline.|||units on a scale||Standard Deviation|Mean
1343318|NCT01900652|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)|EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)|All randomized participants with EORTC QLQ-C30 values at baseline.|||units on a scale||Standard Deviation|Mean
1343319|NCT01900652|Secondary|Overall Survival (OS)|OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.|Baseline to Death Due to Any Cause (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||Months||95% Confidence Interval|Median
1343916|NCT01890577|Secondary|Hemoglobin Excursions|Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
1343321|NCT01900652|Secondary|Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||percentage of participants||95% Confidence Interval|Number
1343322|NCT01900652|Secondary|Change in Tumor Size (CTS)|Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.|Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)|Zero participants analyzed.CTS data was not collected for analysis due to N=0 CR and N=3 PR.||||||
1343323|NCT01900652|Secondary|Time to Progressive Disease||Baseline to Objective Disease Progression (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||months||95% Confidence Interval|Median
1343324|NCT01900652|Secondary|Progression Free Survival (PFS)|"PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.~Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment."|Baseline to Objective Disease Progression or Death (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||Months||95% Confidence Interval|Median
1343325|NCT01900652|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||percentage of participants||95% Confidence Interval|Number
1343326|NCT01900444|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
1343327|NCT01900444|Primary|Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Titer||95% Confidence Interval|Geometric Mean
1343328|NCT01900444|Primary|Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.|Day 28 post-booster injection|Seroconversion rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343329|NCT01900444|Primary|Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).|Day 0 (pre-booster) and Day 28 post-booster injection|Seroprotection rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343330|NCT01900444|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
1343331|NCT01900444|Primary|Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50 test.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Titer||95% Confidence Interval|Geometric Mean
1343332|NCT01900444|Primary|Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.|Day 28 post-booster injection|Seroconversion rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343333|NCT01900444|Primary|Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).|Day 0 (pre-booster) and Day 28 post-booster injection|Seroprotection rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343334|NCT01900431|Secondary|Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration|Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was <11 days or >17 days before the sampling time for every other week regimens.|Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)|PK population: all participants who received at least one dose or part of a dose of investigational medicinal product (IMP) with at least one post-dose, non-missing serum concentration value and were analyzed according to treatment actually received. Data of this endpoint was planned to be analyzed for Sarilumab 200 mg q2w arm in Part A and B only.|||ng/mL||Standard Deviation|Mean
1343335|NCT01900431|Secondary|Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16|Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated.|Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing data for prednisone (or equivalent oral corticosteroid) dose at Week 16.|||Percentage of participants|||Number
1343336|NCT01900431|Secondary|Percentage of Participants Without Retinal Vessel Leakage on Fluorescein Angiography (FA) at Week 16||Week 16|Analysis of this endpoint was not performed as no retinal vessel leakage data was collected at Week 16. Zero participants were analyzed.||||||
1343337|NCT01900431|Secondary|Percentage of Participants With CRT Thickness <300 Microns at Week 16||Week 16|This endpoint was replaced by the percent change from baseline in CRT at Week 16 as this is more clinically relevant. Zero participant was analyzed.||||||
1343338|NCT01900431|Secondary|Percent Change From Baseline in CRT at Week 16|CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.|||percent change||Standard Error|Least Squares Mean
1343339|NCT01900431|Secondary|Change From Baseline in Central Retinal Thickness (CRT) At Week 16|CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.|||µm (microns)||Standard Error|Least Squares Mean
1343340|NCT01900431|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16|BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with BCVA score assessment at baseline and post-baseline visits.|||units on a scale||Standard Error|Least Squares Mean
1343341|NCT01900431|Secondary|Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16|Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count.|Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing AC cell score at Week 16.|||Percentage of participants|||Number
1343342|NCT01900431|Secondary|Change From Baseline in VH Scale at Week 16|Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with VH assessment at baseline and post-baseline visits.|||units on a scale||Standard Error|Least Squares Mean
1343419|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||h*ng/ml||Standard Deviation|Mean
1343343|NCT01900431|Primary|Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16|At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated.|Week 16|Modified intent-to-treat population (mITT) included all randomized participants who received at least 1 injection analyzed according to the group to which the participant was allocated by the randomization schedule. Modified multiple imputation approach was used on VH missing adjudicated scores.|||Percentage of participants|||Number
1343344|NCT01900314|Secondary|Depression Symptoms at 4 Weeks- Secondary|Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22|4 weeks after baseline|Sample analyzed included all participants who entered the study and received MRI scans at baseline and after 4 weeks of treatment. Repeated measures ANCOVA with screening MADRS score as co-variate|||units on a scale||Standard Deviation|Mean
1343345|NCT01900314|Primary|Depressive Symptoms at 4 Weeks|MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression|4 weeks after baseline||||units on a scale||Standard Deviation|Mean
1343346|NCT01900249|Primary|Change of Corneal Fluorescein Staining of the Inferior Cornea Region.|Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.|Baseline to Week 12|The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population.|||units on a scale (Likert)||95% Confidence Interval|Mean
1343347|NCT01900067|Primary|The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group|The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period|temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.||||Degree Celsius (°C)||95% Confidence Interval|Mean
1343348|NCT01900054|Secondary|Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)||Week 12 or suspension|||||||
1343349|NCT01900054|Secondary|Influence of Activities in Daily Life(Study, Outing, Sleeping)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
1343350|NCT01900054|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
1343351|NCT01900054|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
1343352|NCT01900054|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
1343353|NCT01900054|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).|Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）||||units on a scale||Standard Deviation|Median
1343354|NCT01900054|Primary|Number of Patients With Adverse Events and Adverse Drug Reactions||Up to Week 12||||participants|||Number
1343355|NCT01899911|Primary|Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level|Successful capture of SpO2 levels - Infrared and red light absorbency was measured and used for SpO2 percentage calculation from both the Vital Signs Patch (VSP) study device and an invasive Blood Arterial Hemoximeter (standard method) to determine the level of accuracy of data obtained from the VSP device when compared data taken from the Arterial Hemoximeter. A comparison was made by calculating the Average Root Mean Square (Arms) and comparing against the Arms error rate limit of less than or equal to 3.5% at a 95% confidence level. The outcome is either positive or negative - this is a composite outcome measure.|within 24 hrs|Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants|||participants|||Number
1343356|NCT01899768|Secondary|CAC Agent Imputed Dose Concentration Required to Achieve C2, C5 and C6 at Visits 6 and 7 (Part C)|CAC was performed following the administration of GSK2339345 or placebo at Visits 6 and 7. CA was administered using a dosimeter through a nebulizer pot with flow-limitation. Number of coughs in the first and second 15 sec following each dose of CAC agent were recorded. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the participants or the highest available Conc. was used. CAC agent imputed dose concentration required to achieve C2 (at which 2 coughs were first observed [FO]), C5 (at which 5 coughs were FO) and C6 (at which 6 coughs were FO) are presented. For participants who did not complete the challenge and not reached the endpoint, values were imputed to the next dose in the challenge sequence after stopping. For participants who completed the challenge and had not reached the endpoint, values were imputed to 2000 (=twice the highest dose of CA).|After the administration of GSK2339345 or placebo at Visits 6 and 7 in Part C (up to 2 weeks)|CAC Population|||mol/L||Geometric Coefficient of Variation|Geometric Mean
1343420|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax,ss is the time to reach maximum observed plasma concentration at steady state of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||hour||Standard Deviation|Mean
1343357|NCT01899768|Secondary|CC Agent Imputed Dose Concentration Required to Achieve C2, C5 and C6 at Visits 4 and 5 (Part B)|CC was performed following the administration of GSK2339345 or placebo at Visits 4 and 5. Capsaicin was administered using a dosimeter through a nebulizer. The number of coughs in the first and second 15 sec following each dose of CC agent were recorded. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the participant or the highest available Conc. was used. CC agent imputed dose concentration required to achieve C2 (at which 2 coughs were first observed [FO]), C5 (at which 5 coughs were FO) and C6 (at which 6 coughs were FO) are presented. For participants who did not complete the challenge and not reached the endpoint, values were imputed to the next dose in the challenge sequence after stopping. For participants who completed the challenge and had not reached the endpoint, values were imputed to 2000 (=twice the highest dose of capsaicin).|After the administration of GSK2339345 or placebo at Visits 4 and 5 in Part B (up to 2 weeks)|CC Population|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
1343358|NCT01899768|Secondary|CAC Agent Dose Concentration Required to Achieve C2, C5 and C6 at Visits 6 and 7 (Part C)|CAC was performed following the administration of GSK2339345 or placebo at Visits 6 and 7. CA was administered using a dosimeter through a nebulizer pot with flow-limitation. Number of coughs in the first and second 15 sec following each dose of CAC agent were recorded. Inhalation of increased conc. was continued until the maximum dose was tolerated by the participants or the highest available Conc. was used. CAC agent dose concentration required to achieve C2 (2 coughs were first observed [FO]), C5 (5 coughs were FO) and C6 (6 coughs were FO) are presented. All instances of missing values occurred where a participant did not achieved the required number of coughs for a parameter.|After the administration of GSK2339345 or placebo at Visits 6 and 7 in Part C (up to 2 weeks)|CAC population: Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the CAC Population.|||mol/L||Geometric Coefficient of Variation|Geometric Mean
1343359|NCT01899768|Secondary|CC Agent Dose Concentration Required to Achieve C2, C5 and C6 at Visits 4 and 5 (Part B)|CC was performed following the administration of GSK2339345 or placebo at Visits 4 and 5. Capsaicin was administered using a dosimeter through a nebulizer. The number of coughs in the first and second 15 sec following each dose of CC agent were recorded. Inhalation of increased conc. was continued until the maximum dose was tolerated by the participant or the highest available conc. was used. CC agent dose concentration required to achieve C2 (2 coughs were first observed [FO]), C5 (5 coughs were FO) and C6 (6 coughs were FO) are presented. All instances of missing values occurred where a participant did not achieved the required number of coughs for a parameter.|After the administration of GSK2339345 or placebo at Visits 4 and 5 in Part B (up to 2 weeks)|CC population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the CC Population.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
1343360|NCT01899768|Secondary|Mean Number of Cough Counts at Each Dose of the Challenge Agent for the Citric Acid Challenge (CAC)at Visits 6 and 7 (Part C)|Citric acid was administered using a dosimeter through a nebulizer pot with flow-limitation. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the par. or the highest available Conc. was used. The dose-response relationship between the dose of citric acid and cough response was investigated using non-linear mixed effect modelling using Poisson and Negative Binomial distributions. When using a Poisson distribution, there was some evidence for an increase in citric acid ED50 with GSK2339345 of 41.6%, however, this was not confirmed when using a Negative Binomial distribution. The Negative Binomial distribution described the data marginally better, but the dataset was too small to make definitive conclusions. There was no treatment difference in citric acid Emax|After the administration of GSK2339345 or placebo (first and second 15 seconds following each dose) at Visits 6 and 7 in Part C (up to 2 weeks)|CAC Population comprised of participants in the All Subjects Population for whom any CAC data were available for one or both Part C study visits. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Cough count||Standard Deviation|Mean
1343361|NCT01899768|Secondary|Mean Number of Cough Counts at Each Dose of the Challenge Agent for the Capsaicin Challenge (CC) at Visits 4 and 5 (Part B)|Capsaicin was administered using a dosimeter through a nebulizer pot with flow-limitation. Inhalation of increased concentrations (Conc.) was continued until the maximum dose was tolerated by the par. or highest available Conc. was used. The dose-response relationship between dose of capsaicin and cough response was investigated using non-linear mixed effect modeling using Poisson and Negative Binomial distributions. When using a Poisson distribution, there was some evidence for a reduction in capsaicin Emax with GSK2339345 of 17.6%, however, this was not confirmed when using a Negative Binomial distribution. The Negative Binomial distribution described the data marginally better, but the dataset was too small to make definitive conclusions. There was no treatment difference in capsaicin ED50.|After the administration of GSK2339345 or placebo (first and second 15 seconds following each dose) at Visits 4 and 5 in Part B (up to 2 weeks)|CC population. Population comprised of par. in the All Subjects Population for whom any CC data were available for one or both Part B study visits. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||Cough count||Standard Deviation|Mean
1343362|NCT01899768|Secondary|Mean Visual Analogue Scale (VAS) Score of Cough Severity and Urge to Cough at the Indicated Time Points at Visits 1, 2 and 3 (Part A)|VAS for urge to cough and severity of cough were recorded prior to first dose and 1 hour following the second dose of GSK2339345 or placebo at Visits 1, 2 and 3.VAS is a 100-mm linear scales on which participants indicated the severity of their cough (0 mm represents no severity and 100 mm maximum severity ever experienced) and urge to cough (0 represents no urge to cough, 100 represents maximum urge to cough ever experienced). Mean of replicate values per participants used where the same treatment taken during different periods.|Prior to first dose and 1hr post second dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Scores on a scale||Standard Deviation|Mean
1343363|NCT01899768|Secondary|Mean Cough Counts by 15 Min Epoch in Part A|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 15 min time periods continued until an epoch ended immediately before the second dose (or 4h after the first dose if earlier). The epochs were then re-started at the start of the second dose at 15 min intervals, finishing with an epoch which ran to 4-hr after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods.|Up to 8 hours post-dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 15 min cough count value were analyzed.|||Cough count||Standard Deviation|Mean
1343364|NCT01899768|Secondary|Mean Cough Counts by 30 Min Epoch at Visits 1, 2 and 3 (Part A)|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 30 min time periods continued until an epoch ended immediately before the second dose (or 4-hr after the first dose if earlier). The epochs were then re-started at the start of the second dose at 30 min intervals, finishing with an epoch which ran to 4-hr after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods.|Up to 8 hours post-dose in Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 30 min cough count value were analyzed.|||Cough count||Standard Deviation|Mean
1343365|NCT01899768|Secondary|Mean Cough Counts by 1 hr Epoch at Visits 1, 2 and 3 (Part A)|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 60 min time periods continued until an epoch ended immediately before the second dose (or 4-hr after the first dose if earlier). The epochs were then re-started at the start of the second dose at 60 min intervals, finishing with an epoch which ran to 4-hrs after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods. Values were imputed pro-rata if 1 hr epoch is less than 60 min.|Up to 8 hours post-dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 1 hr cough count value were analyzed.|||Cough count||Standard Deviation|Mean
1343366|NCT01899768|Secondary|Total Cough Count Excluding Transient Coughs Over 4 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3 (4-hrs of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. Total count excluding transient cough over 4-hrs was done by using the sum of first 4-hrs starting from the time of first dose and the second 4-hrs starting at the time of the second dose respectively. Number of coughs excluding transient cough in 0-4 hr and 4-8 hr period was log-e transformed and used for the analysis. Values were imputed pro-rata if 4-hr epoch was less than 4-hrs. Mean of the total cough counts over 4-hrs recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 4 hr cough count were analyzed.|||Cough count||Standard Error|Geometric Mean
1343367|NCT01899768|Secondary|Mean Cough Count Over 4 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3 (4- hrs of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count over 4-hrs was done by using the sum of first 4-hrs starting from the time of first dose and the second 4-hrs starting at the time of the second dose respectively. Number of coughs in 0-4 hr and 4-8 hr period was log-e transformed and used for the analysis. Values were imputed pro-rata if 4 hr epoch was less than 4 hr. Mean of the total cough counts over 4-hrs recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 4 hr cough count were analyzed.|||Cough count||Standard Error|Geometric Mean
1343368|NCT01899768|Secondary|Time to Reach the Observed Maximum Concentration (Tmax) of GSK2339345 Following Two Repeated Doses|Tmax is defined as the time to reach the observed maximum GSK2339345concentration following two repeated doses at each visit in Part A. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administered at Visits 1, 2 and 3. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hours||Full Range|Median
1343369|NCT01899768|Secondary|Maximum Observed Concentration (Cmax) of GSK2339345 Following Two Repeated Doses|Cmax is defined as the maximum observed concentration of GSK2339345 following two repeated doses at each visit in Part A. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administration at Visits 1, 2 and 3. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. For Cmax, NCs were imputed prior to derivation of summary statistics and NCs were imputed with 0.5*LLQ (LLQ=0.20 ng/mL).|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1343917|NCT01890577|Primary|Haemoglobin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Each 4-week period for the duration of the study period (15 months)|||||||
1343370|NCT01899768|Secondary|Area Under the Concentration (AUC) Time (0-1) and AUC(0-t) of GSK2339345 Following Two Repeated Doses|AUC curve from time zero (pre-dose) to 1 hours AUC(0-1) and from time zero to the last time AUC(0-t) of quantifiable concentration of GSK2339345 following the first dose and second dose at each visit in Part A was measured. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administration at Visits 1, 2 and 3. For , AUC(0-1) and AUC(0-t), non calculable (NC) were imputed prior to derivation of summary statistics and NCs were imputed as 0.1093 and 0.0855 respectively (=half the lowest observed value).|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1343371|NCT01899768|Secondary|Plasma Concentrations of GSK2339345 at the Indicated Time Points at Visits 1, 2 and 3 (Part A)|Plasma concentrations of GSK2339345 following the first dose and second dose at each visit in Part A was measured. Samples were collected at the following time points: pre-dose, 2 min, 5 min, 10 min, 30 min, 1 hr and 2 hr (only after Dose 1) after each dose administration at Visits 1, 2 and 3. All non-quantifiable (NQ) values after the pre-first dose value imputed to half lower limit of quantification (LLQ) (LLQ=0.2 nanogram per milliliter [ng/mL]). Different participants may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the pharmacokinetic population.|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|The Pharmacokinetic (PK) Population comprised of participants in the All Subjects Population for whom a pharmacokinetic sample was obtained and analysed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||nanogram per milliliter (ng/mL)||Full Range|Median
1343372|NCT01899768|Secondary|Mean Transient Cough Counts at the Indicated Time Points in Part A|Cough counts (8 hours of recording) was conducted at Visits 1, 2 and 3 (4 hours of post-dose recording for each of the two doses administered). Coughs was counted by a cough monitor fitted to the participants for 8 hours post Dose 1. Transient coughing was calculated as the total number of coughs experienced in the two minutes from the start of the first inhalation of a dose. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|0-4 hr, 4-8 hr, 0-8 hr post each dose at Visits 1, 2 and 3 in Part A (up to 8 weeks)|All Subjects Population.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Cough count||Standard Deviation|Mean
1343373|NCT01899768|Secondary|Number of Participants With Perception of Change in Oropharyngeal Sensation at the Indicated Time Points in Part A|The perception of change in oropharyngeal sensation was assessed by a 4 point scale where participants were asked to describe sensitivity and perception of numbness and the responses were recorded. The following information was collected: 0 = no anaesthesia (A), 1 = mild anaesthesia, 2 = moderate anaesthesia and 3 = severe anaesthesia. Oropharyngeal examination was performed at 2 min, 5 min, 15 min, 30 min, 1 hr and 2 hr after FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|From 2 min -2 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
1343374|NCT01899768|Secondary|Mean Forced Expiratory Volume in One Second (FEV1) Values at the Indicated Time Points in Parts A, B and C|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry at pre-dose and 30 min after FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 30 min post each dose administered in Parts A, B and C (up to 8 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
1343375|NCT01899768|Secondary|Mean Troponin I Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of troponin I at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Cardiac troponin values that were below the quantification limit [0.02 or 0.04 microgram (mcg/L)] were imputed as 0.01 (mcg/L).|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||mcg/L||Standard Deviation|Mean
1343376|NCT01899768|Secondary|Mean Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of calcium, chloride, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1343377|NCT01899768|Secondary|Mean Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement ofdirect bilirubin, total bilirubin, creatinine and uric acid at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1343378|NCT01899768|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of ALP, ALT, AST and GGT at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International Units/Liter (IU/L)||Standard Deviation|Mean
1343379|NCT01899768|Secondary|Mean Red Blood Cell Count Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of red blood cell count at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1343380|NCT01899768|Secondary|Mean Corpuscle Volume Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of mean corpuscle volume at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||femtoliters per cell (fL)||Standard Deviation|Mean
1343381|NCT01899768|Secondary|Mean Corpuscle Hemoglobin Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of mean corpuscle hemoglobin at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||picograms per cell (pg)||Standard Deviation|Mean
1343382|NCT01899768|Secondary|Mean Hematocrit Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of hematocrit at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Proportion of one||Standard Deviation|Mean
1343383|NCT01899768|Secondary|Mean Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1343384|NCT01899768|Secondary|Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cells (WBC) Count Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - absolute neutrophil count), platelet count, and white blood cells count at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
1343385|NCT01899768|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings in Parts A, B and C|A 12-lead ECG was recorded in a seated position after the participant was kept at rest in this position for at least 10 minutes. ECGs were obtained at pre-dose and 5 min, 15 min (only in Part A) 30 min, and 1 hr after FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings any time during study. The study investigator determined if the abnormal ECG finding was CS or NCS.|Pre-dose and 5min to 1 hr after each dose administered in Parts A, B and C (up to 8 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
1343386|NCT01899768|Secondary|Mean Body Temperature at the Indicated Time Points in Parts A, B and C|Body temperature measurements were obtained at1 hr post-dose 2 FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|1 hr post the second dose administered in Part A and 1 hr post each dose administered in Parts B and C (up to 8 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Degree Celsius||Standard Deviation|Mean
1343387|NCT01899768|Secondary|Mean Heart Rate at the Indicated Time Points in Parts A, B and C|Heart rate measurements were obtained at following time points: pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr after FA and SA in Part A and each dose administration in Parts B and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Pre-Dose is the average of the triplicate readings taken at the pre-dose assessment.|Pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr after each dose administered in Parts A, B and C (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Deviation|Mean
1343388|NCT01899768|Secondary|Mean Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points in Parts A, B and C|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were obtained at following time points: pre-dose, 5 minutes (min), 15 min (only in Part A), 30 min, and 1 hr after first administration (FA) and second administration (SA) in Part A and each dose administration of Parts B and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Pre-Dose is the average (avg) of the triplicate readings taken at the pre-dose assessment.|Pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr post each dose administered in Parts A, B and C (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1343389|NCT01899768|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|From the start of study treatment and until the follow-up contact (up to 8 Weeks)|All Subjects Population|||participants|||Number
1343390|NCT01899768|Primary|Total Cough Count Excluding Transient Coughs Over 8 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first 4-hrs starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Transient cough was the total number of coughs experienced in the two mins from the start of the first inhalation of a dose. Number of coughs excluding transient cough in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts excluding transient cough recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 8 hr cough count were analyzed.|||Cough count||Standard Error|Geometric Mean
1343421|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||hour||Standard Deviation|Mean
1343485|NCT01897402|Secondary|Solicited Adverse Events From Diary Cards|Local and systemic rates from Diary Cards filled by the participants.|Day 0 to Day 7 after vaccination|Safety Population: All vaccinated participants, grouped by actual vaccine received.|||percentage of participants|||Number
1343391|NCT01899768|Primary|Total Cough Count Over 8 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hours [hr] of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first four hours starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Number of coughs in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts recorded post dose of every treatment i.e. placebo or GSK2339345 1000mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population comprised of all participants who receive at least one dose of study medication. Only participants with at least one 8 hr cough count were analyzed.|||cough count||Standard Error|Geometric Mean
1343392|NCT01899742|Secondary|Change From BL in FEV1 at 3 Hours Postdose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. FEV1 assessments taken on 0 to 3 hour on Day 84 (pre-dose, 5 minutes (min), 15 min, 30 min, 1 hour, and 3 hour post-dose). Pre-dose was the reading obtained at 24 hours after the previous day’s dose (Day 83 dose). BL is defined as mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last OL tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Analysis performed using mixed model repeated measures with covariates of treatment, BL FEV1, center group, 24 hour subset flag, time, time by treatment interaction and time by BL interaction. Only those participants with data available at the specified time point were included in the analysis.|Baseline and Day 84|ITT Population|||Liters||Standard Error|Least Squares Mean
1343393|NCT01899742|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last open label [OL] tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 84 (at Week 12 + 1 day). Analysis performed using a mixed repeated measures model (MMRM) with covariates of treatment, BL, center group, 24 hour subset flag, Day, Day by BL and Day by treatment interactions. ITT Population is defined as participants who received at least one dose of randomized study medication in the treatment period. Only those participants with data available at the specified time point were included in the analysis.|Baseline (BL) and Day 85|ITT Population|||Liters||Standard Error|Least Squares Mean
1343394|NCT01899677|Primary|Interferon Levels at 28+/-2 Days||28+/-2 days||||pg/ml||Inter-Quartile Range|Median
1343395|NCT01899677|Primary|Interferon Levels at 14+/-2 Days||14+/-2 days||||pg/ml||Inter-Quartile Range|Median
1343396|NCT01899677|Primary|Interferon Levels at 0+2 Days||0+2 days||||pg/ml||Inter-Quartile Range|Median
1343397|NCT01899677|Primary|Interleukin 17A Levels at 28+/-2 Days||28+/-2 days||||pg/ml||Inter-Quartile Range|Median
1343398|NCT01899677|Primary|Interleukin 17A Levels at 14+/- 2 Days||14+/- 2 days||||pg/ml||Inter-Quartile Range|Median
1343399|NCT01899677|Primary|Interleukin 17A Levels at 0+2 Days||0+2 days||||pg/ml||Inter-Quartile Range|Median
1343400|NCT01899677|Primary|Interleukin 10 Levels at 28+/-2 Days||28+/-2 days||||pg/ml||Inter-Quartile Range|Median
1343401|NCT01899677|Primary|Interleukin 10 Levels at 14+/- 2 Days||14+/- 2 days||||pg/ml||Inter-Quartile Range|Median
1343402|NCT01899677|Primary|Interleukin 10 Levels at 0+2 Days||0+2 days||||pg/ml||Inter-Quartile Range|Median
1343403|NCT01899677|Primary|Interleukin 5 Levels at 28+/-2 Day||28+/-2 day||||pg/ml||Inter-Quartile Range|Mean
1343404|NCT01899677|Primary|Interleukin 5 Levels on 14+/-2 Day||14+/-2 day||||pg/ml||Inter-Quartile Range|Median
1343405|NCT01899677|Primary|Interleukin 5 Serum Cytokine Level on 0+2 Day||0+2 day||||pg/ml||Inter-Quartile Range|Median
1343406|NCT01899144|Secondary|Participants With Treatment-Emergent Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).~Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|Day 1 up to Day 35|The safety population included all randomized patients who received at least 1 dose of randomized study medication. In this population, treatment was assigned based upon the treatment patients actually receive regardless of the treatment to which they were randomized.|||participants|||Number
1343407|NCT01899144|Secondary|Baseline-Adjusted Area-Under-The- Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose (FEV1 AUC0-6)|FEV1 AUC0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose FEV1 values from each post-dose FEV1 determination.|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set|||L*hour||Standard Error|Mean
1343422|NCT01898884|Secondary|Maximum Observed Serum Concentration at Steady State (Cmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax,ss is the maximum observed plasma concentration at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||ng/mL||Standard Deviation|Mean
1343408|NCT01899144|Primary|Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics. Predicted FEV1 values were computed and adjusted for age, height, and gender for patients aged 4-5 years (Eigen et al 2001) and for patients aged 6-11 years (Quanjer et al 1995) using ATS/European Thoracic Society (ERS) criteria applicable to pediatric patients (ATS/ERS 2007).~The percent predicted FEV1 (PPFEV1) area under the curve (AUC)0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose PPFEV1 values from each post-dose PPFEV1 determination."|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of study medication, had a baseline assessment, and had at least 1 post baseline assessment.|||%predicted FEV1*hour||Standard Error|Mean
1343409|NCT01898884|Secondary|Renal Clearance at Steady State (CLR,ss) of VP 20629 for Multiple Dose Groups|The CLR,ss is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 8.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter per hour||Standard Deviation|Mean
1343410|NCT01898884|Secondary|Percentage of Drug Excreted in Urine at Steady-State (Ae%,ss) of VP 20629 for Multiple Dose Groups|The Ae%,ss is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||percentage of dose||Standard Deviation|Mean
1343411|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine at Steady State (Ae,ss) of Unchanged VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Ae,ss is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||microgram||Standard Deviation|Mean
1343412|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||per hour||Standard Deviation|Mean
1343413|NCT01898884|Secondary|Total Body Drug Clearance at Steady State (CLss/F) of VP 20629 for Multiple Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter per hour||Standard Deviation|Mean
1343414|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Multiple Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter||Standard Deviation|Mean
1343415|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||hour||Standard Deviation|Mean
1343416|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCtau is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||h*ng/mL||Standard Deviation|Mean
1343417|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, n is number of participants analyzed for this outcome measure at given time points."|||h*ng/mL||Standard Deviation|Mean
1343418|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCss is the area under the plasma concentration time curve observed during a dosing at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||h*ng/ml||Standard Deviation|Mean
1345163|NCT01870076|Secondary|Preoperative Cortisol Level|Cortisol level was compared among the 4 study groups.|Labs were drawn immediately pre-op.|Surgical patients who completed Polysomnography and pre-op study labs.|||mcg/dL||Standard Deviation|Mean
1343423|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax is the maximum observed plasma concentration of Multiple Dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1343424|NCT01898884|Secondary|Renal Clearance (CLR) of VP 20629 for Single Dose Groups|The CLR is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 1 or Ae(0-24)/AUC(0-24) on Day 1.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter per hour||Standard Deviation|Mean
1343425|NCT01898884|Secondary|Percentage of Drug Excreted in Urine (Ae%) of VP 20629 for Single Dose Groups|The Ae% is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||percentage of dose||Standard Deviation|Mean
1343426|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine (Ae) for Unchanged VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||microgram (mcg)||Standard Deviation|Mean
1343427|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||per hour||Standard Deviation|Mean
1343428|NCT01898884|Secondary|Total Body Drug Clearance (CL/F) of VP 20629 for Single Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||liter per hour||Standard Deviation|Mean
1343429|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Single Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||Liter||Standard Deviation|Mean
1343430|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||hour||Full Range|Median
1343431|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Plasma Concentration (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUCt is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||h*ng/mL||Standard Deviation|Mean
1343432|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||h*ng/mL||Standard Deviation|Mean
1343433|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
1343434|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||hour||Standard Deviation|Mean
1343446|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (AUC0-t)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours||||ng*hr/mL||Full Range|Geometric Mean
1343435|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Cmax is the maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1343436|NCT01898884|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|ECG included PR interval, QRS interval, QTcB interval, QTcF interval were considered as clinically significant ECG abnormalities.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
1343437|NCT01898884|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included systolic blood pressure, diastolic blood pressure, heart rate, and temperature. Vital signs abnormalities reported as TEAEs were reported.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
1343438|NCT01898884|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 7 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with Grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
1343439|NCT01898884|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs), defined as all AEs that start during study drug treatment (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during study drug treatment (and up to 7 days after the last dose of study drug).|From Start of Study Treatment up to Day 19|The ITT-safety (ITT-S) set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
1343440|NCT01898598|Secondary|Percentage of Participants With BCC Recurrence||Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)|This outcome was based on the cumulative data post MMS Visit and due to early study termination with very few enrolled participants, complete data for this outcome measure could not be collected.||||||
1343441|NCT01898598|Secondary|Percentage of Participants With Skip Area|Skip area was defined as the presence of non-contiguous residual tumor at the MMS visit, as determined by an independent dermatopathologist. MMS visit occurred within 2 weeks of the last study treatment.|MMS visit (Week 12-14)|ITT population.|||Percentage of participants||95% Confidence Interval|Number
1343442|NCT01898598|Secondary|Percentage of Participants With Clinical Response|Clinical response was defined as a complete response (CR) or partial response (PR) at the post-treatment MMS excision. CR was defined as no histological evidence of BCC. PR was defined as a reduction of at least 50 % in the expected surgical defect area with histologic evidence of residual BCC. MMS visit was defined the visit that occurred within 2 weeks of the last study treatment.|MMS visit (Week 12-14)|ITT population.|||Percentage of participants||95% Confidence Interval|Number
1343443|NCT01898598|Secondary|Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit|Percent change in target BCC actual tumor-free margin excision area was defined as = (expected surgical defect area pre-treatment - actual tumor-free margin excision area at MMS visit) / expected surgical defect area pre-treatment) * 100%. The actual tumor-free margin excision area (includes 2 millimeters [mm] margin) was measured during MMS. The area was photographed and traced on the digital photograph then calculated by computer-aided planimetry. MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.|Baseline, MMS visit (Week 12-14)|ITT. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.|||Percent change in margin excision area||Standard Deviation|Mean
1343444|NCT01898598|Secondary|Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit|Actual change was defined as (baseline expected surgical defect area - expected surgical defect area at MMS visit). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment. Expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry).|Baseline, MSS Visit (Week 12-14)|ITT Population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.|||Square millimeter (mm^2)||Standard Deviation|Mean
1343445|NCT01898598|Primary|Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit|The percent change in target BCC expected surgical defect area was defined as ([baseline expected surgical defect area − expected surgical defect area at MMS visit]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.|Baseline, MMS visit (Week 12-14)|ITT population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.|||Percent change in surgical defect area||Standard Deviation|Mean
1343447|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Cmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours||||ng/mL||Full Range|Geometric Mean
1343448|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Tmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours||||hours||Full Range|Geometric Mean
1343449|NCT01898442|Secondary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points|Secondary outcomes included the comparison of the platelet reactivity index (PRI) determined by vasodilator-stimulated phosphoprotein (VASP) at 30 min and 1, 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 1, 2, 4, 8, 24 hours||||PRI||Standard Error|Least Squares Mean
1343450|NCT01898442|Secondary|Platelet Reactivity by VerifyNow P2Y12 at Other Time Points|Secondary outcomes included the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 30 min and 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 2, 4, 8, 24 hours||||PRU||Standard Error|Least Squares Mean
1343451|NCT01898442|Primary|Platelet Reactivity by VerifyNow P2Y12|The primary end-point of the study was the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 1 hour after administration|1 hour||||PRU||Standard Error|Least Squares Mean
1343452|NCT01898403|Primary|Sentinel Lymph Nodes (SLN) Mapping|Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.|Up to 1 year|All participants were evaluated for sentinel lymph nodes (SLN) using Isosulfan Blue (ISB); Indocyanine Green (ICG); and TSC lymphoscintigraphy.|||Sentinel lymph nodes|Sentinel Lymph Nodes||Number
1343453|NCT01898286|Other Pre-specified|Glycemic Control (Change From Baseline in % HbA1c)||Baseline and Early Termination Visit, Up to 25 Months|All patients with % HbA1c data at baseline and their early termination visit. Only 5 patients were available for this analysis, as not all patients agreed to complete HbA1c testing at the early termination visit.|||% HbA1c||Standard Deviation|Mean
1343454|NCT01898286|Other Pre-specified|Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit||Baseline and Early Termination Visit, up to 25 months|All patients with daily insulin dose data at baseline and their early termination visit. Only 11 patients could be included in this analysis, as not all patients provided insulin dose data at their early termination visit.|||IU/kg||Standard Deviation|Mean
1343455|NCT01898286|Secondary|Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.|Baseline and Early Termination Visit, Up to 25 Months|Only 9 patients had sufficient data for this analysis, as many patients declined to undergo the GST at the termination visit.|||nmol*minute/L||Standard Deviation|Mean
1343456|NCT01898286|Primary|Hypoglycemic Events|The number of hypoglycemic events recorded by each patient over the course of the study.|At Early Termination Visit, Up to 25 Months|Patients with hypoglycemic event data at the time of their early termination visit. This population is smaller than the population numbers in the patient flow categories because not all patients were willing to provide information on hypoglycemic events at early termination.|||hypoglycemic events||Standard Deviation|Mean
1343457|NCT01898208|Secondary|Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject|Costs were calculated using a standardized inflation-adjusted estimate of costs for each service or procedure performed in constant dollars. This approach adjusts for hospital-billed charges with Medicare Cost Report department-level cost-to-charge ratios. Physician services were proxied with Medicare reimbursement rates based on Current Procedure Terminology (CPT)-4 codes using the Medicare Fee Schedule. We did not include the cost of the stewardship program in the cost analysis, as it is not a billed service. As there was no Medicare reimbursement rate for the rmPCR test at the time of the study, test cost was proxied using the FilmArray respiratory panel. These costs were varied in sensitivity analysis with rmPCR test cost ranging from a 50% decrease to a 300% increase.|Approximately 7 days after positive blood culture and for duration of entire hospitalization|The number of subjects analyzed per arm is different than the number of subjects who completed the study because outpatients and a few subjects without final billing data available were excluded.|||dollars||Standard Deviation|Mean
1343458|NCT01898208|Secondary|Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment||Approximately within 72 hours of positive blood culture||||percentage of participants|||Number
1343459|NCT01898208|Secondary|Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events|This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.|Approximately 14 days after positive blood culture||||participants|||Number
1343460|NCT01898208|Secondary|All-cause and Attributable Mortality|If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.|30 days after positive blood culture||||participants|||Number
1343461|NCT01898208|Secondary|Length of Entire Hospitalization (Days)||Participants were followed for the duration of hospital stay, approximately 15 days||||days||Inter-Quartile Range|Median
1343462|NCT01898208|Other Pre-specified|Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment|Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.|Approximately 30 days after positive blood culture||||percentage of participants|||Number
1343463|NCT01898208|Other Pre-specified|Length of Intensive Care Unit Stay||within 14 days of positive blood culture until ICU discharge||||days||Inter-Quartile Range|Median
1343465|NCT01898208|Secondary|Time to Pathogen Identification||Approximately 14 days after positive blood culture|The number of subjects analyzed per arm differs from the number of subjects who completed the study because this outcome measure includes only the subset of subjects who had organisms represented on the rapid multiplex PCR (rmPCR) panel.|||hours||Inter-Quartile Range|Median
1343466|NCT01898208|Secondary|Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours|Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.|Within 14 days after positive blood culture||||Percentage of blood cultures|||Number
1343467|NCT01898208|Secondary|Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics|De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic.|Positive Gram stain, 96 hours after enrollment|Not all subjects experienced de-escalation or escalation of their antibiotics. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship).|||hours||Inter-Quartile Range|Median
1343468|NCT01898208|Secondary|Time From Positive Gram Stain to First Active Antibiotic|From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.|Approximately 14 days after positive blood culture|Not all subjects were not on active therapy at enrollment, and also subjects with contaminated blood cultures were excluded. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship): (n=45, 41, 37)|||hours||Inter-Quartile Range|Median
1343469|NCT01898208|Primary|Duration of Antimicrobial Therapy (Hours)|Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.|Approximately 4 days after enrollment|Subjects could have received more than one antimicrobial. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship)|||hours||Inter-Quartile Range|Median
1343470|NCT01898195|Secondary|End-of-intervention Smoking Abstinence|number of participants who achieved smoking abstinence based on self-reported 7-day point prevalence smoking abstinence verified by a carbon monoxide (CO) < 8 ppm|7 Days||||participants|||Number
1343471|NCT01898195|Primary|End-of-intervention Varenicline Adherence|number of participants who took at least 80% prescribed dose since last interview, based on pill count|4 Weeks||||participants|||Number
1343472|NCT01898091|Primary|Maximum Change in Mean Mouth and Throat Soreness (MTS) Score From Baseline Through Weeks of Radiation Therapy Using the MTS Question of the Modified Oral Mucositis Daily Questionnaire*.|Severity is assessed as the maximum change in mean mouth and throat soreness (MTS) score from baseline during the weeks of RT, using MTS question of the validated Oral Mucositis Daily Questionnaire (modified OMDQ): “During the past 24 hours, how much mouth and throat soreness did you have?” The MTS score is a 5-point score, ranging from 0=No soreness to 4=Extreme soreness. We compared the maximum change in MTS score between the two groups using the Wilcoxon rank sum test with a one-sided alpha of 0.05.|MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.|Exclusion criterion was those with a baseline mouth and throat soreness (MTS) extreme score of 4.|||units on a scale||Standard Deviation|Mean
1343473|NCT01897792|Secondary|Mean Number of Hospital Stay Days.|The mean number of days subjects were in the hospital in each arm of the study|from enrollment up to 60 days post enrollment||||days||Full Range|Mean
1343474|NCT01897792|Secondary|Mean Number of Days in ICU.|the mean number of days each subject was in the ICU in each arm|from enrollment up to 60 days post enrollment||||days||Full Range|Mean
1343475|NCT01897792|Secondary|Mean Number of Ventilator-free Days for Subjects|The mean number of ventilator free days (not on ventilator) for subjects in each arm|from enrollment up to 60 days post enrollment||||days||Full Range|Mean
1343476|NCT01897792|Secondary|Number of Subjects With 60-day Survival|Number of subjects in each arm that survived to day 60|from enrollment up to 60 days post enrollment||||participants|||Number
1343477|NCT01897792|Secondary|Number of Subjects Surviving to Day 28|Number of subjects that survived to day 28 after enrollment|from enrollment up to 28 days post enrollment||||participants|||Number
1343478|NCT01897792|Secondary|Number of Protocol Violations Per Arm.|The number of times that there was a deviation or violation from how the protocol was to be implemented.|from enrollment up to 60 days post enrollment||||protocol deviations|||Number
1343479|NCT01897792|Primary|Number of Total Blood Product Transfusions|the number of blood product transfusions for all subjects in each group over the course of 3 days.|From enrollment to 3 days||||blood transfusions|||Number
1343480|NCT01897792|Primary|Number of Subjects With Organ Injury|Any injury to internal organs (thoracic, abdominal or cranial cavity)|From enrollment to 3 days||||participants|||Number
1343481|NCT01897792|Primary|Number of Subjects With Ventilator-associated Pneumonia.|Number of subjects diagnosed with pneumonia and requiring ventilator support.|From enrollment to 3 days||||participants|||Number
1343482|NCT01897792|Primary|Number of Participants With Coagulation Abnormalities|Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E.|From enrollment up to 3 days||||participants|||Number
1343483|NCT01897727|Primary|Severity of Obstructive Sleep Apnea|3 month change in apnea-hypopnea index assessed by diagnostic, full-night polysomnography. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe.|baseline and 3 months||||events/hour||Standard Deviation|Mean
1343484|NCT01897402|Secondary|Non Solicited Adverse Events|Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.|up to 6 months|Safety Population: All vaccinated participants, grouped by actual vaccine received.|||participants|||Number
1343486|NCT01897402|Primary|Seroresponse (Percent Seroconversion).|Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a 4-fold rise in antibody levels.|Week 4 after injection|Per Protocol Population|||percentage of per protocol participants||95% Confidence Interval|Number
1343487|NCT01897285|Secondary|Safety - the Nature and Frequency of Adverse Events|"Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded.~Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction."|7 days||||participants|||Number
1343488|NCT01897285|Primary|Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)|"Adhesion at 7 days measured by:~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Conformability~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Dressing Integrity~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Ease of Application~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Ease of Removal,~1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult~Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable~Comfort during removal~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)"|7 days|20/20 subjects completed maximum study participation of 7 days. Two subjects dressings detached very early on so returned for their final evaluation on the second day. The final subject status was recorded as ‘other’ for these two subjects. Many dressings detached when volunteers were away from the clinic and prior to returning for the assessments.|||participants|||Number
1343489|NCT01897233|Secondary|Part B: Pre-dose Concentration (Ctrough) and 3 to 6 Hours Post-dose Concentration (C3-6hr) of Lumacaftor, Lumacaftor Metabolite (M28-LUM), Ivacaftor and Ivacaftor Metabolites (M1-IVA and M6-IVA)|Ctrough and C3-6hr for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. Ctrough was observed pre-dose concentration. C3-6hr was observed concentration at 3 to 6 hours post- dose.|For Ctrough: pre-morning dose on Week 4, Week 6 and Week 24; For C3-6hr: 3 to 6 hours post-morning dose on Day 1, 15 and Week 4|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable. Here “n” signifies those participants who were evaluable at the specified time point for the given category.|||ng/mL||Standard Deviation|Mean
1343490|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domains at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
1343491|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1343492|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score (height z-score). The height-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
1343493|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||centimeter (cm)||95% Confidence Interval|Least Squares Mean
1343494|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (weight z-score). The weight-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
1343495|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
1343496|NCT01897233|Secondary|Part B: Absolute Change From Baseline in BMI-for-age Z-score at Week 24|BMI was defined as weight in kg divided by height*height in m^2. z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score). The BMI-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
1343497|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
1343498|NCT01897233|Secondary|Part B: Absolute Change in Sweat Chloride From Week 24 at Week 26|Sweat samples were collected using an approved collection device. Change = Week 26 minus Week 24.|Week 24, Week 26|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||mmol/L||95% Confidence Interval|Least Squares Mean
1343499|NCT01897233|Secondary|Part B: Average Absolute Change From Baseline in Sweat Chloride at Day 15 and at Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. Average of Day 15 and Week 4 measurements was taken and change was calculated as: Average (Day 15 and Week 4 measurement) minus Baseline measurement.|Baseline, Day 15 and Week 4|The Full Analysis Set (FAS) included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1343500|NCT01897233|Secondary|Part A: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose through the end of Part A were considered treatment-emergent.|Day 1 up to Day 28|The Safety Set included all participants who received at least 1 dose of study drug. Here “n” signifies those subjects who were evaluable for the specified cohort.|||participants|||Number
1343501|NCT01897233|Secondary|Part A: Observed Plasma Concentration of Lumacaftor Metabolite (M28-LUM) and Ivacaftor Metabolites (M1-IVA and M6-IVA) at Hour 4 Post-dose (C4h) on Day 1 and 14||Day 1, Day 14|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
1343502|NCT01897233|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose to Week 26 were considered treatment-emergent.|Day 1 up to Week 26|The Safety Set included all participants who received any amount of Part B study drug|||participants|||Number
1343503|NCT01897233|Primary|Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA)|The AUCtau is the area under the concentration versus time curve from time 0 to time tau, where tau is the time at the end of dosing interval.|Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||ng*hr/mL||Full Range|Median
1343504|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14||4 hours post-morning dose on Day 14|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
1343505|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1||4 hours post-morning dose on Day 1|The Pharmacokinetic (PK) Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1343506|NCT01897077|Secondary|Number of Participants With Serious Adverse Events With Dosing||18 months|No participants were analyzed for this secondary outcome in the peanut allergic group because no data was collected due to early termination of the study|||participants|||Number
1343507|NCT01897077|Secondary|Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy|Only in peanut allergic subjects|18 months|No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study||||||
1343509|NCT01897077|Secondary|Number of Participants With Serious and Non-serious Adverse Effects With Therapy||18 months|No participants were analyzed for this secondary outcome in the peanut allergic group because data was not collected due to early termination of the study|||Participants|||Count of Participants
1343510|NCT01897077|Secondary|The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study|For peanut allergic subjects only|18 months|No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study||||||
1343511|NCT01897077|Primary|The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons|No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.|18 months|There were no peanut allergic subjects enrolled because the study ended prematurely due to manufacturing issues with the study product.|||Participants|||Count of Participants
1343512|NCT01897025|Secondary|MRI Parameters|active and passive fMRI, DTI, This part of data is still under analyzing.|-2, 0 and 4 weeks||2015-12-31|12/2015||||
1343513|NCT01897025|Secondary|Box and Block Test|Box and block test was to measure the gross manual dexterity. This part of data is still under analyzing.|pre and post training, and 4 weeks post training||2015-12-31|12/2015||||
1343514|NCT01897025|Secondary|Grip Strength|Grip strength was measured using a hand-held dynamometer. This part of data is still under analyzing.|pre- and post-training, and again at 4 weeks post-training||2015-12-31|12/2015||||
1343515|NCT01897025|Secondary|Resting Motor Threshold of Stroke Affected M1 Motor Cortex|"Resting motor threshold (RMT) is defined as the percentage of maximum stimulator output required to elicit motor evoked potential (MEP) with 50 µV peak-to-peak amplitude in at least 4 out of 8 trials during single-pulse transcranial magnetic stimulation (TMS).~Short intra-cortical inhibition (SICI) and intracortical facilitation (ICF) were measured using paired pulse stimulation with an initial conditioning stimulus of 80% of RMT and a test stimulus of 120% of RMT. MEPs were recorded at inter-stimulus intervals (ISIs) of 2, 4, 6, 10 and 15 ms. ISIs of 1-3 ms typically induce SICI while ISIs of 10-15ms typically reflect ICF.~This part of data is still under analyzing."|pre- and post-training, 4 weeks post-training||2015-12-31|12/2015||||
1343516|NCT01897025|Primary|Upper Extremity Component of Fugl-Meyer Assessment|The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).|week 0, week 2, week 4|Subjects aged 21 to 70 years who had their first-ever subcortical stroke at least 9 months before recruitment, with moderate to severe impairment of upper extremity function (subscore of the Fugl-Meyer Motor Assessment [FMMA], 11-45), were recruited.|||units on a scale||Standard Deviation|Mean
1343517|NCT01896986|Primary|Immunogenicity to HPV Vaccine Gardasil|To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children’s Hospital (RCH) Melbourne .|12 months|No immunogenicity data collected as samples were lost.||||||
1343518|NCT01896934|Secondary|Change in Patient-rated Depression Severity|Change in depression severity measured by the patient-rated Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report measure of depression severity with a range of 0-27, with higher scores indicative of more severe depression.|Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported||||units on a scale||Standard Error|Mean
1343519|NCT01896934|Secondary|Change in Clinician-rated Depression Severity|Change in depression severity will be measured by the clinician-rated Montgomery Asberg Depression Rating Scale (MADRS), range of 0-60, with higher scores indicating more severe depression|Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported||||units on a scale||Standard Deviation|Mean
1343520|NCT01896934|Primary|Remission of Depression|Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less.|Week 12|Individuals achieving remission of depression, defined as MADRS score of 7 or less.|||Participants|||Count of Participants
1343521|NCT01896895|Secondary|Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141)|PEGR scale is a descriptive subjective 9-point response self-rating scale ranging from “complete abolishment of signs and symptoms” (value=+4) down to “very marked worsening” (value=-4). Outcome values represent least square means at visit 4 resulting from an ANCOVA with treatment group, pooled site, gender as fixed factors and age as covariates. Missing were set to a zero effect (value=0). Positive values denote an improvement, while negative values denote deterioration.|Baseline, Final Visit (Day 43-Day 141)|FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available.|||score on a scale||95% Confidence Interval|Least Squares Mean
1343522|NCT01896895|Secondary|Double-blind MP: Change From Baseline in Blepharospasm Disability Index (BSDI) at Day 43 (Visit 4)|BSDI is a scale for assessment of impairment of specific activities of daily living caused by blepharospasm. BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranging from 0 (=no impairment) to 4 (=no longer possible due to illness). The BSDI total score is a mean score for non-missing items ranging from 0 to 4. It is calculated by adding scores of all applicable and answered items, and dividing the resulting sum by the number of items answered. Outcome values represent LS mean differences between baseline and visit 4 (visit 4 value minus baseline value) resulting from ANCOVA with treatment group, pooled site, gender as fixed factors and baseline BSDI total score, age as covariates. Missings were replaced by the LOCF method. Negative values denote an improvement, while positive values denote deterioration vs. baseline.|Baseline, Day 43 (Visit 4)|FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available.|||score on a scale||95% Confidence Interval|Least Squares Mean
1343560|NCT01896193|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1346506|NCT01848145|Secondary|Overall Survival|Defined as the time from first treatment until death from any cause.|For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.||||months||95% Confidence Interval|Median
1343523|NCT01896895|Primary|Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4)|JRS severity subscore was used to classify individual symptoms of blepharospasm and to determine therapeutic efficacy. JRS severity subscore ranges from 0 to 4, where 0: None; 1: increased blinking present with external stimuli; 2: Mild but spontaneous eyelid fluttering, definitely noticeable, possibly embarrassing, but not functionally disabling, 3: Moderate, very noticeable spasm of eyelids only, mildly incapacitating, 4: Severe, incapacitating spasm of eyelids and possibly other facial muscles. Values represent least square (LS) mean differences between baseline and visit 4 resulting from analysis of covariance (ANCOVA) with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates and missings replaced using the last observation carried forward (LOCF) method. Negative values denote improvement, while positive values denote deterioration vs. baseline.|Baseline, Day 43 (Visit 4)|FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available.|||score on a scale||95% Confidence Interval|Least Squares Mean
1343524|NCT01896726|Primary|PK: AUC(0-∞) of Levonorgestrel||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of levonorgestrel.|||pg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1343525|NCT01896726|Primary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of ethinyl estradiol.|||picograms*hour/milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1343526|NCT01896726|Primary|PK: Cmax of Levonorgestrel||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of levonorgestrel.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1343527|NCT01896726|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of ethinyl estradiol.|||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1343528|NCT01896700|Secondary|Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks|Mean changes in VOR phase, which is a measure of the timing (in degrees) of the eye movements relative to the chair movement, as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.|6 weeks|Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.|||change in degrees from baseline||Standard Deviation|Mean
1343529|NCT01896700|Secondary|Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks|Mean changes in VOR asymmetry, which is a measure of the strength of the eye responses in one direction compared with the other as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.|6 weeks|Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.|||change in % of asymmetry from baseline||Standard Deviation|Mean
1343530|NCT01896700|Secondary|Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks|The most common rotary chair testing is a battery of subtests, each at a specific rate (Hz) of chair rotation from side to side. The participant is secured in the chair in total darkness while the eyes are monitored by infrared cameras. We completed tests from 0.04 to 0.64 Hz to assess the vestibular system across a range of head movements. The chair and participant’s head move together while the cameras track the velocity of the eyes; eye velocity reveals how the vestibular system responds to head velocity. VOR gain is the ratio of average chair (i.e. head) velocity to average eye velocity, and is represented on a unitless scale from 0 to 1. VOR gain close to 1 indicates that eye velocity is nearly equal and opposite to head velocity. While there are normative ranges for VOR gain, we are most interested in is change in mean gain (6-week tests minus baseline tests) for the active and placebo groups.|6 weeks|Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.|||ratio||Standard Deviation|Mean
1343531|NCT01896700|Secondary|Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks|Mean changes in the score attached on the Modified Fatigue Index Scale at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-84 points, with higher scores indicating greater fatigue.|6 weeks||||change in score from baseline||Standard Error|Mean
1343532|NCT01896700|Secondary|Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks|Mean changes in the score attained on the Pittsburgh Sleep Quality Assessment Questionnaire at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-21 points, with higher numbers indicating poorer sleep quality.|6 weeks||||change in score from baseline||Standard Error|Mean
1343533|NCT01896700|Secondary|Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks|Mean changes in Timed 25 Foot Walk (T25FW) at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.|6 weeks||||change in seconds from baseline||Standard Error|Mean
1344028|NCT01889238|Other Pre-specified|Number of Participants With Study Drug Discontinuation Due to Adverse Events||Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
1343534|NCT01896700|Secondary|Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks|Mean changes in APR latency at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.|6 weeks|Population discrepancy: One participant in the intervention group and two participants in the placebo group contributed unusable APR data; due to their balance deficits, the machine could not get an accurate reading for this test. One participant in the intervention group declined this test. These four participants were not included in analysis.|||change in milliseconds from baseline||Standard Error|Mean
1343535|NCT01896700|Primary|Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks|The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at 6 weeks. Mean changes will be compared for active and placebo treated subjects using Bayesian analysis.|6 weeks||||change in seconds from basline||Standard Error|Mean
1343536|NCT01896687|Primary|Worst Low Back Pain Score|"Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from 0 meaning no pain to 10 meaning pain as bad as you can imagine."|baseline to 3 weeks post-treatment||||units on a scale||Standard Deviation|Mean
1343537|NCT01896557|Other Pre-specified|Comparison of the Primary Outcome With PFA-100 (Collagen/ADP Cartridge)|After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: PFA-100(Collagen/ADP cartridge).|1 week after drug exposure|Platelet aggregation by PFA-100 was measured after one week of randomized treatment therapy|||seconds||Standard Deviation|Mean
1343538|NCT01896557|Other Pre-specified|Comparing the Main Outcome on Pre-specified Subgroups|"The main outcome will be compared on pre-specified subgroups:~elderly (age > 65 yrs-old) versus non-elderly~male versus female~smoking versus non-smoking patients~obese (BMI > 30 kg/m2) versus non-obese~diabetic versus non-diabetic~patients in use or not in use of statins~presence or not of genetic polymorphisms on cytochrome 2C19."|1 week after drug exposure|||||||
1343539|NCT01896557|Other Pre-specified|Comparison of the Primary Outcome With Bioimpedance Aggregometry|After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: bioimpedance aggregometry with ADP 10 mcM as reagent|1 week after drug exposure|Platelet aggregation was measured after one week of randomized treatment therapy|||Ohms||Standard Deviation|Mean
1343540|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as the percent change in aggregability from baseline, with the formula IPA = (on-treatment aggregability minus baseline aggregability)/baseline aggregability. Since baseline aggregation is always, per definition, equal or more than on-treatment aggregation, there is no possibility that this number might be negative.|One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline||||Percentage||Standard Deviation|Mean
1343541|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units.|One week after randomized treatment exposure (omeprazole or ranitidine)||||P2Y12 Reactivity Units||Standard Deviation|Mean
1343542|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum hsCRP.|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days||||mg/L||Inter-Quartile Range|Median
1343543|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|"Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of:~1) 30 day hospital readmission; and 2) 30 day mortality."|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days||||participants|||Number
1343544|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of: 1) ICU length of stay; and 2) hospital length of stay|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days||||days||Inter-Quartile Range|Mean
1343545|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum LL-37.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days||||ng/mL||Inter-Quartile Range|Median
1343561|NCT01896193|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
1343546|NCT01896544|Primary|Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibroblast growth factor 23; 5) Vitamin D binding protein; 6) LL-37; 7) Parathyroid hormone; 8) Albumin; 9) Calcium; and 10) Phosphorus levels.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days||||ng/mL||Inter-Quartile Range|Median
1343547|NCT01896297|Primary|Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose|Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)|2 hours after the last drug administration, on day 8|PKS. Analysis includes patients with available data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1343548|NCT01896297|Primary|Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).|Immediately before the last drug administration, on day 8|Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1343549|NCT01896232|Secondary|Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks|"The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.~For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis."|First 8 weeks|Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.|||vomiting episodes per week||Standard Error|Least Squares Mean
1343550|NCT01896232|Secondary|Mean Severity of Nausea in the First 8 Weeks|Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.|First 8 weeks|Full analysis set with available data|||units on a scale||Standard Error|Least Squares Mean
1343551|NCT01896232|Secondary|Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase||Efficacy assessment phase (weeks 20 - 27)|Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.|||percentage of participants|||Number
1343552|NCT01896232|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (weeks 20 - 27)|Full analysis set with available data.|||percent change||Standard Error|Mean
1343553|NCT01896232|Secondary|Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks|Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.|First 8 weeks|Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.|||days of vomiting or nausea per week||Standard Error|Least Squares Mean
1343554|NCT01896232|Secondary|Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).|||percentage of participants|||Number
1343555|NCT01896232|Secondary|Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).|Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).|||percentage of participants|||Number
1343556|NCT01896232|Primary|Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis||Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|Full analysis set participants with PTH data during the EAP|||percentage of participants|||Number
1343557|NCT01896206|Primary|The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.|To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.|Participants will be followed for the duration of surgery, an expected average of 2 hours.|The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.|||mmHg||Standard Deviation|Mean
1343558|NCT01896193|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
1343559|NCT01896193|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1343583|NCT01895634|Secondary|All Cause Mortality||90 days post-procedure||||participants|||Number
1343562|NCT01896193|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1343563|NCT01896115|Other Pre-specified|Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and dorsal and ventral current steering settings. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit||||units on a scale||Standard Deviation|Mean
1343564|NCT01896115|Other Pre-specified|Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering|Resting tremor was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and current steering settings, at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming Visit||||units on a scale||Standard Deviation|Mean
1343565|NCT01896115|Other Pre-specified|Dorsal-Ventral Current Steering Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, this measure reports the stimulus amplitude difference between the full rigidity control threshold and the first stimulation induced side effect threshold at current steering settings (current divided 50% between adjacent electrodes).|Day 1 programming visit|The therapeutic window of short pulse widths vs. conventional pulse widths was a primary outcome measure and is reported as such in another section of this report.|||mA||Standard Deviation|Mean
1343566|NCT01896115|Secondary|Finger Tapping Amplitude - Single Contact vs. Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).|||units on a scale||Standard Deviation|Mean
1343567|NCT01896115|Secondary|Resting Tremor Severity - Single Contact vs. Steering|Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).|||units on a scale||Standard Deviation|Mean
1343568|NCT01896115|Secondary|Side Effect Thresholds - Single Contact vs. Steering|This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths. Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).|||mA||Standard Deviation|Mean
1343569|NCT01896115|Primary|Unified Parkinson's Disease Rating Scale III|"The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings.~The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108."|Day 1 programming visit|All subjects were analyzed at both pulse widths. Primary outcomes were only intended to be assessed for different pulse widths and not current steering.|||UPDRS III score||Standard Deviation|Mean
1343570|NCT01896115|Primary|Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.|Day 1 programming visit|"Therapeutic window for current steering settings was not a primary outcome measure but is described later as an Other outcome measure."|||mA||Standard Deviation|Mean
1343571|NCT01896050|Secondary|Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months|Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment|baseline and 12 months||||participants|||Number
1343572|NCT01896050|Secondary|Effect of Medication on Change in Grip Strength|Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months|baseline and 12 months||||percent change||Standard Deviation|Mean
1343584|NCT01895634|Secondary|Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)||24-hour post procedure|Missing value was not be imputed (1 missing subject was because of the death within 24 hours)|||participants|||Number
1343573|NCT01896050|Primary|Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy|Change in BMI between baseline and 12 months of endocrine therapy|baseline and 12 months|These data only include patients who completed a full 12 months of treatment with either an aromatase inhibitor or tamoxifen and had grip strength data at both baseline and 12 months. Patients could have switched from one aromatase inhibitor to another. Those patients who discontinued treatment prior to the 12 month period were excluded.|||kg/m^2||Standard Deviation|Mean
1343574|NCT01895972|Primary|Clinical Safety|Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with >/=1 ocular AE Specifics of AEs are captured in the AE section.|1 year|Safety Population (Study Eye)|||Participants|||Count of Participants
1343575|NCT01895972|Primary|Change From Baseline in Intraocular Pressure|Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.|Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52|Safety population|||mm Hg||Standard Deviation|Mean
1343576|NCT01895946|Secondary|Efficacy: Progression-free Survival (PFS)|PFS is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression. Subjects who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||weeks||Inter-Quartile Range|Median
1343577|NCT01895946|Secondary|Efficacy: Target Lesion Size, Best Percentage Change From Baseline|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.~best percentage change in tumour size from baseline is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction from baseline based on all post baseline assessments."|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Percentage change from baseline||Standard Deviation|Mean
1343578|NCT01895946|Secondary|Efficacy: Target Lesion Size, Percentage Change From Baseline at Week 12|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.~The percentage change in target lesion tumour size at each week 12 for which data are available was obtained for each subject taking the difference between the sum of the target lesion at each week 12 and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline multiplied by 100 (i.e. (week 12) - baseline)/baseline * 100)."|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Percentage change from baseline||Standard Deviation|Mean
1343579|NCT01895946|Secondary|Efficacy: Disease Control at Week 12|Disease control = confirmed complete response + confirmed partial response + stable disease at 12 weeks|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Participants|||Number
1343580|NCT01895946|Secondary|Efficacy: Best Objective Response (BOR)|"Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines for measurable, non-measurable, target lesions (TLs) and non-target lesions (NTLs) and the objective tumour response criteria was used.~Categorisation of objective tumour response assessment was based on the RECIST 1.1 guidelines for response: CR (complete response, efined as disappearance of all target lesions), PR (partial response, defined as >=30% decrease in the sum of the longest diameter of target lesions), SD (stable disease, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) and PD (progression of disease, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion). BOR was the best overall response observed across the study and up to 36 weeks. Number of subjects with response (CR or PR) is described."|Assessed every 6 weeks, up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Participants|||Number
1343581|NCT01895946|Primary|Ratio of AUCss for Day 4 to Day 11|"The actual sampling times were used in the parameter calculations and PK parameters were derived using standard non-compartmental methods.~Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:~Css max, tss max, Css min, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and CLss/F.~Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.~Ratio of AUCss for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.|||Ratio||90% Confidence Interval|Geometric Mean
1343582|NCT01895946|Primary|Ratio of Css,Max for Day 4 to Day 11|"The actual sampling times were used in the pharmacokinetics (PK) parameter calculations and PK parameters were derived using standard non-compartmental methods.~Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:~Maximum plasma concentration at steady state (Css max), time to Css,max (tss max), minimum plasma concentration at steady state (Css min), area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and apparent clearance (CLss/F).~Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.~Ratio of Css,max for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.|||Ratio||90% Confidence Interval|Geometric Mean
1343585|NCT01895634|Secondary|Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure|"The Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death, or similar, as accurate."|90 days post procedure|Missing value was not be imputed (1 missing subject was because of the missing data at 90 days by subject IC withdrawal)|||participants|||Number
1343586|NCT01895634|Secondary|Proportion of Subject Who Have Clot Migration/Embolization||immediately post procedure||||participants|||Number
1343587|NCT01895634|Primary|Proportion of Patients Who Have Recanalization|Proportion of subjects who had recanalization, TICI 2a or better|immediately post procedure||||participants|||Number
1343588|NCT01895608|Secondary|Change Scores in Activities-specific Balance-related Confidence|Subjects' decreased confidence in a variety of situations will be measured using the Activities-specific Balance Confidence scale which has good test-retest reliability. Sixteen activities are each assessed on a scale ranging from 0 to 100, where higher scores indicate greater confidence in performing the activity. Item scores are averaged to arrive at a final score, where average scores <67% indicate a greater fall risk.|baseline and 6 weeks||||overall percentage of confidence||Standard Deviation|Mean
1343589|NCT01895608|Secondary|Change Scores in Preferred Gait Speed|Subjects walk at their preferred speed and time to walk 6 m is recorded.|baseline and 6 weeks||||meters per second||Standard Deviation|Mean
1343590|NCT01895608|Secondary|Change Scores in Sensory Organization Test (SOT)|"SOT is organized into a series of 6 conditions of increasing difficulty: 3 involve a firm surface with eyes open, eyes closed and with vision sway-referenced and 3 involve a sway-referenced surface with eyes open, eyes closed, and with vision sway-referenced. SOT has good reliability and differentiates fallers and nonfallers.~The SOT composite score is used for statistical analysis with a maximum score of 100 (indicating perfect stability) and a minimum score of 0 (indicating severe instability). Higher scores indicate better performance (i.e., greater postural stability) and SOT composite scores less than 38 out of 100 indicate fall risk."|baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
1343591|NCT01895608|Secondary|Change Scores in Dynamic Gait Index|"Dynamic Gait Index (DGI) assesses gait under 8 conditions and has excellent interrater as well as test-retest reliability.~Each of the 8 conditions is scored on a scale from 0 (indicating severe impairment) to 3 (indicating normal ability). The total score is used for statistical analysis with a maximum score of 24 and a minimum score of 0 with a higher score indicating better performance. A total DGI score less than 20 out of 24 indicates fall risk."|baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
1343592|NCT01895608|Secondary|Change Scores in Walk While Talk Test With Verbal Fluency Task|The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task.|baseline and 6 weeks||||seconds||Standard Deviation|Mean
1343593|NCT01895608|Primary|Change Scores in Timed up and go With Cognitive Task|Timed up and go test (TUG) has three conditions: no secondary task (TUG), cognitive (TUGc) and manual dual-tasks (TUG-m). Time to complete the task with the cognitive task was recorded as a primary outcome measure. Time greater than 15 s for TUG-c indicates impaired dual-task ability.|baseline and 6 weeks||||seconds||Standard Deviation|Mean
1343594|NCT01895543|Secondary|Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score|"The EQ VAS presents the participant's self-evaluated health on a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. This scale is numbered from 0 to 100, where '100' means best health you can imagine and '0' means worst health you can imagine. The participant simply mark an 'X' on the scale to indicate how his/her health is TODAY and mention the same number in a box provided."|At Week 12, 24, 36 and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
1343595|NCT01895543|Secondary|Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores|EQ-5D-5L is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels (1-5 denotes): no problems, slight problems, moderate problems, severe problems, and extreme problems, respectively. A unique health state was defined by combining 1 level from each of the 5 dimensions. Each health state was converted into a single EQ-5D-5L index value. The index values are country specific and values specified for United Kingdom (UK) were used for this study. The index value range for UK lies between -0.594 - 1.000. A positive index value represents better health status while the negative value represents poor health status.|At Week 12, 24, 36 and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
1343596|NCT01895543|Primary|Number of Patients Using Concomitant Medications|The concomitant medications details were collected throughout the trial at all visits. Data were obtained at scheduled or unscheduled trial visits based on information provided spontaneously by the patient or as a result of questioning the patient.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
1343597|NCT01895543|Secondary|Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score|PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific QOL. The questionnaire is based on a 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better QOL. The PAC-QOL questionnaire is developed specifically for patients with constipation. PAC-QOL has four sub-scales: ‘Worries and Concerns’, ‘Physical Discomfort’, ‘Psychosocial Discomfort’, and ‘Dissatisfaction’.|At Week 12, 24, 36 and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
1343598|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Treatment Effectiveness|The treatment effectiveness score was measured on a 5-point scale (1: extremely effective, 2: quite a bit effective, 3: moderately effective, 4: little bit effective, 5: not at all effective).|At Week 12, 24, 36, and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
1343599|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Constipation Severity|The constipation severity score was measured on a 5-point scale (1: none to 5: very severe).|At Week 12, 24, 36, and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
1343653|NCT01894672|Secondary|Response Rate|Response rate (defined as complete + partial response) and 95% confidence interval will be estimated.|1.5 years||||percentage of participants||95% Confidence Interval|Number
1343600|NCT01895543|Secondary|Use of Concomitant Over-the-counter (OTC) Laxatives|The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF).|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
1343601|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs|Vital signs were measured at all visits and included blood pressure (BP: measured after the patient had been in a seated position for ≥3 minutes of rest), pulse, respiration rate, body temperature, and body weight.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
1343602|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs)|A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
1343603|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables|Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
1343604|NCT01895543|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)|The Investigator recorded all AEs throughout the trial from the time of obtaining informed consent till the last visit (i.e., Visit 6). Information on AE was collected at each visit. All AEs were recorded in AE log for each patient.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
1343605|NCT01895452|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period."|Up to 12 months|The full analysis set consists of all subjects who received at least 1 dost of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
1343606|NCT01895452|Secondary|Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.|Up to 12 months|The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
1343607|NCT01895452|Primary|Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)|This measure includes all incidences, including those that occurred >5%.|Up to 12 months|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.|||Participants|||Count of Participants
1343608|NCT01895335|Secondary|Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48|EDSS is a method of quantifying disability in MS participants and monitoring changes in the level of disability over time. EDSS quantifies disability in 8 functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. EDSS scale ranges from 0 to 10 in 0.5 unit increments that represents higher levels of disability. EDSS score 1.0 to 4.5 refers to people with MS who are fully ambulatory; EDSS score 5.0 to 9.5 refers to impairment to ambulation; EDSS score 10 refers to death due to MS.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1343609|NCT01895335|Secondary|Change From Baseline in Stern Leisure Activity Scale at Week 48|The Stern Leisure Activity Scale is a self-reported scale that consists of 13 questions assessing the participant’s participation in leisure activities during the preceding month. One point is given for participation in each of the 13 activities and an aggregate score (range from 0 to 13) is obtained. ≤ 6 score is considered as low leisure activity and > 6 score as high leisure activity.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1343610|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48|The MusiQoL is a quality of life questionnaire that consists of 31 questions, divided into 9 dimensions: activities of daily living, physiological well-being, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping, rejection and relationship with healthcare system. All the 9 dimension scores and the global scores are linearly transformed and standardized on 0 (worst outcome) -100 (best outcome) scale. Higher scores represents higher quality of life.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1343611|NCT01895335|Secondary|Duration of Teriflunomide Treatment Exposure|Duration of exposure was defined as last dose date – first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.|||Days||Standard Deviation|Mean
1343612|NCT01895335|Secondary|Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period|Percentage of compliance for a participant was defined as the number of days that the participant was compliant (1 tablet/day) divided by the exposure duration in days (from the first dose administration to the last dose administration) times 100.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.|||percentage of participants|||Number
1343763|NCT01892865|Primary|Difference Between the Actual and Predicted Length of Operative Day (in Minutes)|The scheduling imprecision between the two scheduling approaches will be compared. Scheduling imprecision is defined as the difference between the actual and predicted length of operative day.|Three years|We analyzed data from 107 operative days in the HM arm, and 100 days in the PMS arm|||Minutes||Standard Deviation|Mean
1343613|NCT01895335|Secondary|Overview of Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during from first study drug intake up to 112 days after last intake for participant with no accelerated elimination procedure (AEP) or to last AEP follow up visit for participants with AEP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP|Safety Population that included all treated participants who received at least 1 dose or part of a dose of IMP.|||percentage of participants|||Number
1343614|NCT01895335|Secondary|Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48|SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The score is computed as a ratio of number of correct responses divided by the total number of responses. The test score range from 0 (worst outcome) to 1 (best outcome). Higher scores are indicative of better cognition function.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1343615|NCT01895335|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48|A treated relapse was defined as a relapse treated by a systemic corticosteroid treatment or by another DMT. If a participant had no treated relapse before treatment discontinuation/completion, then the participant was considered as free of treated relapse until the date of treatment discontinuation/completion. Only treated relapse occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. Kaplan-Meier method was used to estimate the probability of treated MS relapse at 4, 24 and 48 weeks.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.|||percent probability of treated relapse||95% Confidence Interval|Number
1343616|NCT01895335|Secondary|Annualized Treated Relapse Rate|Annualized treated relapse rate was defined as the total number of treated relapses during the study treatment period divided by the total number participants-years of treatment. Only events occurred during the treatment period (first drug administration to last drug administration) were considered for analysis.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.|||relapses per patient-year|||Number
1343617|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48|MSPS was a self-reported measure for MS associated disability in which participants were asked to indicate the category that best described their condition during the past month on the following 8 subscales: mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms and spasticity symptoms. MSPS used a single question to assess each of 8 subscales. All of the subscales ranged from 0= normal to 5= total disability, except mobility subscale which ranged from 0= normal to 6=total disability. Total MSPS score ranged from 0 =normal to 41=greater disability, where higher score reflected greater disability.|Baseline, Week 24, Week 48|Analysis was performed on Efficacy population. Here, ‘n’ signifies number of participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
1343618|NCT01895335|Secondary|Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48|PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale consists of 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1343619|NCT01895335|Secondary|Change From Week 4 in TSQM Scores in Naïve Participants to Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction.|Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1343620|NCT01895335|Secondary|Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .|Baseline, Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1343672|NCT01894256|Other Pre-specified|Free AUC of Olaparib|AUC of unbound olaparib; calculated by multiplying total AUC by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1343621|NCT01895335|Primary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 – Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48|"TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14).~Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Week 48|Efficacy population that included all treated participants. Number of participants analyzed = participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1343622|NCT01895322|Secondary|Percent Change in Body Weight|Percent change in body weight from baseline during the repeated-administration period(For five days).|100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>||||Percentage||Standard Deviation|Mean
1343623|NCT01895322|Primary|Percent Change in Daily Urine Volume From Baseline|Percent change in daily urine volume from baseline during the repeated-administration period (For five days).|100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>||||Percentage||Standard Deviation|Mean
1343624|NCT01895322|Secondary|Change in Body Weight From Baseline|Change in body weight from baseline during the repeated-administration period(For five days).|Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period||||kg||Standard Deviation|Mean
1343625|NCT01895322|Primary|Change in Daily Urine Volume From Baseline|Change in daily urine volume from baseline during the repeated-administration period (For five days).|Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.||||mL||Standard Deviation|Mean
1343626|NCT01895309|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52||||percentage of participants|||Number
1343627|NCT01895309|Secondary|ACR20||Week 52||||percentage of participants|||Number
1343628|NCT01895309|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24||||percentage of participants|||Number
1343629|NCT01895270|Primary|Change Over Time in Illicit Opioid Use Via Urine Toxicology Screens During Buprenorphine Taper (Wks 5-6)|Illicit results via urine toxicology screens for heroin and several opioids will be measured thrice weekly during the taper|thrice weekly for approx 2 weeks (taper)|Urine data of subjects that received at least one dose of isradipine and returned for at least one visit in which a urine drug screen was obtained were included in the analysis|||opioid-positive urine|Urine drug screen results|Standard Error|Least Squares Mean
1343630|NCT01895127|Primary|Percent Change in Estimated Glomerular Filtration (eGFR) Rate|Percent change in eGFR rate at 3 months post-treatment using the modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.|Month 3|1 subject in the SOC arm received rescue therapy, per protocol, with eculizumab following PP/IVIg. 1 subject in the Soliris arm received SOC therapy (PP/IVIg) following completion of Soliris treatment period. Both of these subjects received both SOC and Soliris treatment prior to Month 3 protocol biopsy so we have listed their outcome separately.|||percent change in eGFR from wk 0 to mo 3||Full Range|Mean
1343631|NCT01895101|Secondary|Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)|The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.|participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks||||IU||Standard Deviation|Mean
1343632|NCT01895101|Secondary|Number of Participants Requiring Surgical Re-exploration|the secondary objective of this study is to determine whether pericardial lavage with saline gives an improvement in haemostasis, compared with no pericardial lavage, resulting in a reduction of surgical re-explorations and post-operative 12-hour blood loss. The choice for a surgical re-exploration will be decided according to the ICU protocol.|participants will be followed for the duration of ICU stay, an expected average of 2 days||||participants|||Number
1343633|NCT01895101|Primary|Postoperative Blood Loss|The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure|12 hours postoperative||||ml||Inter-Quartile Range|Median
1343634|NCT01895088|Primary|Change (Increase) in Uncorrected Near Visual Acuity|The change in the number of lines of threshold visual acuity achieved postoperatively.|Baseline and 2 years||||lines of visual acuity improvement||Standard Deviation|Mean
1343635|NCT01895062|Secondary|The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.|interventions such as reduction of sedative medication or jaw thrust.|1 hour||||interventions to restore airway|||Number
1343636|NCT01895062|Secondary|The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.||1 hour|||||||
1343637|NCT01895062|Secondary|The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.||1 hour|||||||
1343638|NCT01895062|Primary|RI Events in the cNEP Group Compared to the no cNEP Group, Where RI is Defined as Either: i Oxygen Saturation < 90% or ii. Apneas/Hypopneas of > 15 Sec Duration i. Oxygen Saturation <90% ii. Presence of Apneas or Hypopneas|Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)|1 hour|Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several.|||RI events||95% Confidence Interval|Mean
1343639|NCT01895036|Primary|Successful Discontinuation of Buprenorphine|Number of individuals successfully discontinuing buprenorphine during the inpatient phase and through follow-up.|7 weeks||||Participants|||Count of Participants
1343640|NCT01894984|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment|Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation.|Month 6|Analysis population included all enrolled participants.|||Participants|||Number
1344055|NCT01888003|Primary|Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery|number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery|post hospital discharge through 90 days after surgery|Subjects dropped out of study prior to day 90||||||
1343641|NCT01894984|Secondary|Percentage of Participants Attaining Remission Criteria|Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual’s behavior.|Month 6|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||Percentage of Participants|||Number
1343642|NCT01894984|Secondary|Percentage of Participants With Relapse at Week 24|Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition.|Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||Percentage of Participants|||Number
1343643|NCT01894984|Secondary|Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||units on a scale||Standard Deviation|Mean
1343644|NCT01894984|Secondary|Total Personal and Social Performance (PSP) Score|The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||units on a scale||Standard Deviation|Mean
1343645|NCT01894984|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 24|Intent to treat (ITT) population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||units on a scale||Standard Deviation|Mean
1343646|NCT01894906|Secondary|Dialysate OutFlow Iron Concentration|Dialysate outflow iron concentration was calculated for each treatment group at t = 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||micrograms/L||Standard Deviation|Mean
1343647|NCT01894906|Secondary|Dialysate InFlow Iron Concentration|Dialysate inflow iron concentration was calculated for each treatment group at t = 0, 0.5, 1, 2, 3, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||micrograms/L||Standard Deviation|Mean
1343648|NCT01894906|Primary|Net Iron Delivery From SFP Via the Dialysate|To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||microgram||Standard Deviation|Mean
1343649|NCT01894906|Secondary|Pharmacokinetics of Serum Iron and Exploratory Modeling|The serum Total Iron, Transferrin Bound Iron (TBI) and Non-transferrin Bound Iron (NTBI) pharmacokinetic parameters (baseline corrected and total) will be listed and summarized for each membrane group and overall. The mean serum total iron, TBI, NTBI, unsaturation iron binding capacity (UIBC) and total iron binding capacity (TIBC) concentrations at baseline (BL), end-of-treatment, and the change from BL will be listed for each group (Baxter and Gambro Polyflux), measured from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate).|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||microgram/dL||Standard Deviation|Mean
1343650|NCT01894906|Secondary|To Compare the Amount of SFP-derived Iron Administered Under Various Treatment Conditions to the Reference HD|To compare the amount of SFP-derived iron administered under various treatment conditions to the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate): Dialyzer reuse, Low machine bicarbonate delivery, Polyarylethersulfone (PAES) membrane, and Low Qb/Qd.Iron concentration in timed dialysate collections will be analyzed. Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||microgram||Standard Deviation|Mean
1343651|NCT01894672|Other Pre-specified|Pharmacokinetic (PK) Analysis: Geometric Mean of Maximum Observed Concentration (Cmax) of LGX818 at Steady State|PK parameters will be determined on PK profiles after the first dose and at steady-state using non-compartmental method(s) using WinNonlin|Cycle 1 - Day 1, 15; Cycle 2 - Day 15; Cycle 3 - Day 1, Day 15|Data were not collected||||||
1343652|NCT01894672|Other Pre-specified|Overall Survival|Overall survival will be calculated for the start of treatment to the date of last death or follow-up.|1.5 years||2018-08-31|08/2018||||
1343654|NCT01894672|Primary|Number of Participants With Response According to RECIST v1.1 Criteria|Efficacy for all patients will be evaluated by the study sites using RECIST v1.1 and response criteria based on contrast-enhanced CT. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|1.5 years||||Participants|||Count of Participants
1343655|NCT01894620|Secondary|Improvement in Sleep Quality|We anticipate to see an improvement on the sleep quality of the patients (assessed by EEG waves during sleep) after 4 weeks of rTMS treatment.|After four weeks after the start of treatment|Note that this aspect of the study was not performed. Therefore, no data is available.||||||
1343656|NCT01894620|Primary|Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA)|We anticipate to see a cognitive improvement as measured by the Montreal Cognitive Assessment (MoCA) after two weeks of applying rTMS. This assessment tool gives a score from 0 to 30 points, with higher scores representing better cognitive ability.|Change between baseline and 2 weeks after the start of treatment|Results are divided into the two treatment type groups (real vs. sham).|||MOCA score change at 2 weeks||Standard Error|Mean
1343657|NCT01894607|Secondary|Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)|Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.|1 day|1 participant was ineligible.|||participants|||Number
1343658|NCT01894607|Primary|Successful Capture of IO-CEUS Images|Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.|1 day|1 participant was ineligible.|||participants|||Number
1343659|NCT01894581|Primary|Change in the Average LH Pulse Amplitude|To test the pituitary and hypothalamic output, we examined LH secretion (unstimulated and in response to gonadotropin-releasing hormone (GnRH) stimulation) during 8-hour blood sampling studies at 10 min intervals. The primary outcome measure is the change in the average LH pulse amplitude for each patient from baseline to after supplementation.|10 minute intervals during 8 hour blood sampling studies. Subjects will undergo two menstrual cycles of study, one prior to dietary supplementation and one after supplementation.||||IU/L||Standard Deviation|Mean
1343660|NCT01894555|Primary|Changes in Platelet Transcriptome|"Comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after aspirin therapy.~The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area"|4 weeks|The data were analyzed combining results from two studies (33 from this study and additional 24 individuals from study NCT02234427; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.|||FPKM difference for HBG1 Gene||Standard Error|Mean
1343661|NCT01894503|Secondary|Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ|Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml.|Days 3, 7, 14, 21 and 30|Per-treatment evaluable population consisting of all patients|||participants|||Number
1343662|NCT01894503|Primary|Number of Sinuses With Successful Implant Delivery|Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure|End of baseline procedure|Per-treatment evaluable population, consisting of all sinuses in which placement of the S8 Sinus Implant was attempted.|||Sinuses|Sinuses||Count of Units
1343663|NCT01894477|Secondary|Relapse Risk as Measured by Degree of Change in Gene Expression Profiles|Among genes identified whose expression is modified by conditioning, degree of change in expression will be evaluated to determine if it is correlated with relapse risk and offers improved prediction of relapse risk over that obtained with standard clinical parameters (cytogenetics, blast count, International Prognostic Scoring System score, minimal residual disease. To account for censoring and the competing risk of non-relapse mortality (NRM), the analysis will be a time-to-event analysis of relapse using Cox regression, with change in expression as a continuous covariate (on a log scale). 8|Baseline and at day 0 within 6 hours of conditioning prior to transplant||2019-04-30|04/2019||||
1343664|NCT01894477|Secondary|Change in Gene Expression Profiles|Differences between arms in the changes in gene expression will be compared. 80% power to detect mean differences of approximately 1.4 standard deviation units, at the 2-sided 0.05 level of significance (with Bonferroni correction for 50 genes).|Baseline and at day 0 within 6 hours of conditioning prior to transplant||2019-04-30|04/2019||||
1343665|NCT01894477|Secondary|Overall Survival (OS)||Up to 2 year||2019-01-31|01/2019||||
1343666|NCT01894477|Secondary|NRM||Up to 5 years|||||||
1343667|NCT01894477|Secondary|Incidence of Relapse/Progression||Up to 5 year|||||||
1343668|NCT01894477|Secondary|Incidence of Chronic GVHD Graded by the NCI CTCAE Version 4.0||Up to 5 year||2022-01-31|01/2022||||
1343669|NCT01894477|Secondary|Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 84 days||||Participants|||Count of Participants
1343670|NCT01894477|Primary|Number of Participants That Did Not Progress Within 6 Months|Progression is defined as relapse|At 6 months post-transplant||||Participants|||Count of Participants
1343671|NCT01894256|Other Pre-specified|CL/F of Unbound Olaparib|Calculated from dose divided by free AUC|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L/hour||Standard Deviation|Median
1343673|NCT01894256|Other Pre-specified|Free Cmax of Olaparib|Cmax of unbound olaparib; calculated by multiplying total Cmax value by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1343674|NCT01894256|Other Pre-specified|Protein Binding of Olaparib|Degree to which olaparib binds to the proteins within blood plasma|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||% plasma||Standard Deviation|Mean
1343675|NCT01894256|Primary|t1/2 of Olaparib|Terminal half-life of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||Hours||Standard Deviation|Mean
1343676|NCT01894256|Primary|CLR of Olaparib|Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24|Part A: Day 1, 0-12 hours and 12-24 hours post-dose|"Subset of PK analysis set with urine samples available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L/hour||Standard Deviation|Mean
1343677|NCT01894256|Primary|CL/F of Olaparib|Apparent plasma clearance of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L/hour||Standard Deviation|Mean
1343678|NCT01894256|Primary|Vz/F of Olaparib|Apparent volume of distribution of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L||Standard Deviation|Mean
1343679|NCT01894256|Primary|Tmax of Olaparib|Time to reach maximum plasma concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||Hours||Full Range|Median
1343680|NCT01894256|Primary|AUC0-t of Olaparib|Area under plasma concentration-time curve from zero to the last measurable time point of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1343681|NCT01894256|Primary|AUC of Olaparib|Area under plasma concentration-time curve from zero to infinity of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1343682|NCT01894256|Primary|Cmax of Olaparib|Maximum plasma drug concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1343683|NCT01894230|Secondary|Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8|"Questionnaire administered at baseline, 3 months, and 8 months~This instrument assesses beliefs regarding necessity and concerns related to disease-specific medications~The score ranges from 5 to 25 representing the sum of 5 questions. This will be modeled with linear regression including treatment as predictor. Baseline BMQ scores will also be included as a covariate to account for baseline variability.~Higher score corresponds to higher thought necessity and higher thought concerns about taking the medication. The higher the necessity score, the more the patient believed statins necessary for their health. The higher the concerns score, the more the patient was concerned about taking stains (side effects)."|Baseline, Month 3, Month 8|Only subjects that completed the Beliefs About Medications questionnaire were included in the analysis.|||units on a scale||Standard Deviation|Mean
1343684|NCT01894230|Secondary|Physical Activity Scale Score|"Activity levels will be compared at the end of 8-months. Activity levels are defined by a five-level ordinal variable (0-4; higher level corresponding to higher activity). which was calculated based on survey answers. An ordinal logistic regression model will be used with arm as predictor. The assumption of proportional odds will be checked, and if it is not met, a multinomial regression model will be used. -Baseline physical activity will also be included as a covariate to account for baseline variability.~Scale score (0-4): 0 - Inactivity, 1 - Ligh-intensity activity, 2 - moderate-intensity activity, 3 - Hard-intensity activity, 5 - very hard-intensity activity"|Baseline and Month 8|Only subjects that completed the Physical Activity survey were included in the analysis|||units on a scale||Standard Deviation|Mean
1343685|NCT01894230|Secondary|Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)|"Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.~Ranges from 0 to 100, where a zero score indicates the lowest level of mental health measured by the scales and 100 indicates the highest level of mental health."|Baseline, Month 3, Month 8|Only subjects that completed the SF-12 Health Survey were included in the analysis.|||units on a scale 0 to 100||Standard Deviation|Mean
1344056|NCT01888003|Primary|Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital|Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital|post surgery through discharge, an average of 2 days||||participants|||Number
1343686|NCT01894230|Secondary|Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)|"Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.~Ranges from 0 to 100, where a zero score indicates the lowest level of physical health measured by the scales and 100 indicates the highest level of physical health"|Baseline, Month 3, Month 8|Only subjects that completed the SF-12 Health Survey were included in the analysis.|||units on a scale||Standard Deviation|Mean
1343687|NCT01894230|Secondary|Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8|"Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. -Pain severity and pain interference will be compared between groups -Both of these measures will be modeled as a linear regression with arm as predictor. Baseline pain scores will also be included as a covariate to account for baseline variability.~Scores range from 0-10. Higher scores indicate higher pain interference with daily activities."|Month 3 and Month 8|Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.|||units on a scale||Standard Deviation|Mean
1343688|NCT01894230|Secondary|Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8|"Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. Pain severity and pain interference will be compared between groups. Both of these measures will be modeled as a linear regression with arm, genotype, and site as predictors. Transformations of the response may be explored depending on the distribution of the regression residuals. Baseline pain scores will also be included as a covariate to account for baseline variability.~Scores range from 0-10. Higher scores indicate higher pain severity."|Month 3 and Month 8|Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.|||units on a scale||Standard Deviation|Mean
1343689|NCT01894230|Secondary|Number of Participants Reporting New Statin Prescriptions|The number of new prescriptions is binary and will be modeled with logistic regression with arm, genotype, and site as predictors. Any variables imbalanced between arms will also be included as covariates.|Baseline, Month 3, Month 8|Only subjects reporting new prescriptions were included in the analysis.|||Participants|||Count of Participants
1343690|NCT01894230|Secondary|Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up|Medication possession ratio will be calculated based on number of statin medication refills over time from randomization to end of follow up. MPR is calculated as follows: 1.Sum of the days' supply of all statin medications is the sum of the number of pills dispensed for each statin prescription during follow up (taken from 3-month, 4-month and 8-month statin utilization review) 2.Sum of the days of follow up = date of 8-month follow up survey - date of randomization 3.MPR = #1/#2 MPR will be modeled as a linear regression with arm, genotype, and site as predictors.|Baseline to Last patient follow-up in study (3 months or 8 months)|Only subjects who re-initiated statin medication and reported statin medication refills were included in the analysis.|||ratio||Standard Deviation|Mean
1343691|NCT01894230|Secondary|Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8|The continuous outcomes LDLc will be modeled as a linear regression with arm and baseline LDL as predictors.|Baseline, Month 3, Month 8|All subjects with available data were included in the analysis.|||mg/dL||Standard Deviation|Mean
1343692|NCT01894230|Primary|Morisky Medication Adherence Scale (MMAS) Score|The Morisky Medication Adherence Scale (MMAS) is a self-reported measure of adherence, collected at baseline for general medication and at 3 and 8 months of followup for statin specific adherence. The eight-item MMAS survey will be used. This is a modified version of the original four-item MMAS capturing further aspects of adherence behavior. The survey includes 8 yes/no items that are summed to create an overall adherence score ranging from of 0 to 8, with higher scores indicating better adherence. The primary hypothesis is that the genetically guided statin therapy leads to greater adherence of statin therapy, corresponding to a higher MMAS score.|3 months and 8 months|Only participants who re-initiated statin use were eligible to do statin specific MMAS and included in the analysis.|||units on a scale||Standard Deviation|Mean
1343693|NCT01894100|Secondary|Change in Lower Extremity Physical Function|For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale. The physical function subscale includes 17 items that ask about difficulty with stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, and light household duties. Participants rate each item on a scale of 0-4 (no difficulty to extreme difficulty. Totals scores for this subscale range from 0-68 (no difficulty to extreme difficulty).|Baseline and 3 months post intervention||||units on scale||Standard Deviation|Mean
1343694|NCT01894100|Primary|Change in Pain Intensity|Western Ontario and McMasters Universities Osteoarthritis Index pain subscale is a 5 item questionnaire that asks participants to rate their pain during walking, using stairs, in bed, sitting or lying, and standing. Each item is rated by the participant as 0-4 (no pain to extreme pain). Total scores on the pain subscale range from 0 to 20 (no pain to extreme pain).|Baseline and 3 months after initiating intervention||||units on a scale||Standard Deviation|Mean
1343695|NCT01894087|Secondary|Substance Use - Current Opioid Misuse Measure|"This measure contained 8 items from the Current Opioid Misuse Measure. Items were assessed on a scale of “never (0),” “rarely (1),” “sometimes (3),” “often (4),” and “very often (5). A sum score took a range of 0 to 40, with higher numbers indicating more non-medical opioid use. For group means reported here, change scores were calculated by subtracting the baseline level of this measure from the level at 6 months follow-up. This change score has a possible range of -40 to 40, with lower values indicating greater decreases in non-medical opioid use."|6 months post-baseline|Participants retained at follow-up and with complete item data on this measure at both baseline and follow-up|||Scores on a scale||95% Confidence Interval|Mean
1343696|NCT01894087|Primary|Behavioral Intentions|Behavioral intentions were assessed with three items that measured participant's intention to use overdose risk reduction strategies. The three strategies were (1) using opioids as prescribed, (2) reducing or avoiding use of alcohol, drugs, or non-prescribed medications, and (3) avoiding combining substances. Each item was assessed on a scale of 1 to 10, with higher numbers indicating greater intention to avoid overdose risk.|6 months post-baseline|Participants retained at follow-up and with complete item data on the outcome at baseline and follow-up|||Scores on a scale||95% Confidence Interval|Mean
1343697|NCT01894087|Primary|Overdose Knowledge|Overdose symptom knowledge was assessed using an inventory of 5 true symptoms and 2 false symptoms of overdose, and the total score created as the sum of correct answers, with a range of 0 to 7. Due to the skewed distribution, this total score was standardized by subtracting the observed responses from the overall sample mean, and then dividing by the standard deviation. This resulted in a range of -5.4 to 2.6 in this sample at the 6 month follow-up, with higher numbers indicating greater overdose symptom knowledge. Also reported here are change scores generated by subtracting the standardized sum score at 6 months from the baseline standardized sum score, which had a range of -3.0 to 6.4 in this sample. Thus, higher numbers in this “change” variable indicated greater improvements in overdose symptom knowledge. Negative numbers would represent a decrease in symptom knowledge.|6 months post-baseline|Participants retained and follow-up and with complete data on the outcome measure items at baseline and follow-up.|||Scores on a scale||95% Confidence Interval|Mean
1343698|NCT01894087|Primary|Overdose Risk Behavior|This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 28 in one assessment. Results reported here as group means are for the change in sum score between baseline and follow-up, which had a possible range of -28 to 28, with lower values indicating greater decreases in overdose risk behavior.|6 months post-baseline|Participants who were retained at follow-up and had complete data for all items for this measure at baseline and follow-up|||Scores on a scale||95% Confidence Interval|Mean
1343699|NCT01894022|Secondary|Time to First Addition of Another Targeted PAH Therapeutic Agent Due to Deterioration of Clinical Condition or Lack of Beneficial Effect With Previous Therapy in Any Participant|"The time to addition of another targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to the following reasons:~Deterioration of clinical condition; Lack of beneficial effect with previous therapy (not reaching set treatment goals). PAH therapies were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first addition of another targeted PAH therapeutic agent. This decision was documented in the reporting and analysis plan prior to database lock."|From Entry visit of the extension study up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population.||||||
1343700|NCT01894022|Secondary|Time to First Change in Dose of Open-label Ambrisentan Due to Deterioration of Clinical Conditions in Any Participant|The time to change in dose of ambrisentan or other targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to deterioration of clinical condition. Dosing data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first change in dose of open-label ambrisentan. This decision was documented in the reporting and analysis plan prior to database lock.|From Entry visit of the extension study up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||||||
1343701|NCT01894022|Secondary|Percent Change From Start of Ambrisentan Treatment in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The NT-proBNP data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. The ratio to start of ambrisentan in NT-proBNP was calculated as the ratio of the value at the specified time-point to the start of ambrisentan value and was expressed as a percent change from start of ambrisentan. This was done by taking the mean change on the log scale, exponentiating, subtracting 1 and multiplying by 100. Standard deviation (SD) of the logged values (log[SD]) have been presented. As par. started to receive ambrisentan treatment in 2 studies, 2 different time points for start of ambrisentan treatment were used for this analysis. For par. who received ambrisentan treatment in study AMB115811, the Baseline for that study was used. For par. who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Percent change||Standard Deviation|Geometric Mean
1343702|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in Borg CR10 Scale (BCR10S) Immediately Following Exercise at the Indicated Time Points|The BCR10S data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. BCR10S score, a rating of perceived exertion, ranges from 0 to 10 (0=nothing at all, 10 extremely strong). If par.’s perception or feeling was stronger than “10”, a larger number could be used. As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Scores on a scale||Inter-Quartile Range|Median
1343709|NCT01894022|Secondary|Change From Study AMB115811 Baseline (BL) in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points|WHO FC indicates severity of pulmonary arterial hypertension (PAH) and is an adaptation of the New York Heart Association classification, assessed by the investigator. There are 4 grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). Grades mapped to numeric scale 1-4 (i.e. Class IV = 4). WHO FC system links symptoms with activity limitations, allowing clinicians to predict disease progression and prognosis. AMB115811 BL is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 BL was calculated as the value at the indicated visit minus the BL value (positive change = worsening). Par.'s final visit in AMB115811 was used as entry visit of this ext study. For Ext study, the visit schedule (M1,3,6,9,12 and 15) was mapped to the visit schedule (M5,7,10,13,16 and 19) for continuity with study AMB115811. Only par. available at the specified TP were analyzed (represented by n=X,X in the category title).|During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Scores on a scale||Inter-Quartile Range|Median
1343703|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points|The WHO functional class data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. There are 4 grades for WHO FC based on severity of symptoms of pulmonary arterial hypertension (Class I = none, Class IV = most severe). Grades mapped to numeric scale 1-4 (i.e. Class IV = 4). As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value (positive change = worsening). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Scores on a scale||Inter-Quartile Range|Median
1343704|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in 6 Minutes Walking Distance at the Indicated Time Points|The 6 minute walk distance data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Meters||Inter-Quartile Range|Median
1343705|NCT01894022|Secondary|Percent Change From Study AMB115811 Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The ratio to Baseline in NT-proBNP was calculated as the ratio of the value at the specified time-point to the AMB115811 Baseline value and was expressed as a percent change from AMB115811 Baseline. This was done by taking the mean change on the log scale, exponentiating, subtracting 1 and multiplying by 100. Standard deviation (SD) of the logged values (log[SD]) have been presented. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. For the Extension study, the visit schedule (Months 1, 3, 6, 9, 12 and 15) was mapped to the visit schedule (Months 5, 7, 10, 13, 16 and 19) for continuity with study AMB115811. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Percent change||Standard Deviation|Geometric Mean
1343706|NCT01894022|Secondary|Change From Study AMB115811 Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36)|The SF-36 version 2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Baseline of study AMB115811 was to be used. Change from study AMB115811 Baseline was to be calculated as the value at the indicated visit minus the Baseline value. The SF-36 data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including the SF-36. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline from study AMB115811 up to End of Study for the extension study (assessed up to approximately 20 months)|ITT Population||||||
1343707|NCT01894022|Secondary|Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Time to clinical worsening of CTEPH was defined as the time from randomization in study AMB115811 to the first occurrence of any of the following events: death (all cause), lung transplantation, hospitalization for CTEPH deterioration, atrial septostomy, addition of parenteral prostanoids, appearance of two or more CTEPH worsening events. Worsening events included: >=20% of decrease in 6MWD; >=1 increase of WHO Functional Classes; worsening right ventricular failure; rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (SBP <85 mmHg).|From randomization up to End of Study for the extension study (assessed up to approximately 20 months)|ITT Population|||Participants|||Number
1343708|NCT01894022|Secondary|Change From Study AMB115811 Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at the Indicated Time Points|"BCR10S score, a rating of perceived exertion, was collected immediately following completion of the 6-minute walk test. Scores range from 0 to 10 (0=nothing at all, 10=extremely strong). If par.'s perception or feeling was stronger than 10, that is “extremely strong”, “Maximal” –a larger number could be used, for example 12 or still higher, that is “Absolute maximum”). AMB115811 BL data was calculated as average of 2 BCR10S values obtained following the 2 6MWD tests used in determining the BL 6MWD in that study. If only 1 measurement was available, it was used. Change from AMB115811 BL was calculated as the value at the indicated visit minus the BL value. Par.'s final visit in AMB115811 was used as the entry visit of ext study. For the Ext study, the visit schedule (M1,3,6,9,12 and 15) mapped to the visit schedule (M5,7,10,13,16 and 19) for continuity with AMB115811. Only those par. available at the specified time points were analyzed (represented by n=X,X in the category titles)."|During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (Ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Scores on a scale||Inter-Quartile Range|Median
1343727|NCT01893567|Secondary|Investigator Reported Effectiveness Scores||2 weeks|||||||
1344102|NCT01887132|Other Pre-specified|Autism Diagnostic Observation Schedule (ADOS) at 6, 12 and 18 Months||6, 12 and 18 months|||||||
1343710|NCT01894022|Secondary|Change From Study AMB115811 Baseline in the 6 Minutes Walking Distance (6MWD) at the Indicated Time Points|The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a par. can walk in a period of 6 minutes. AMB115811 Baseline was the Week 0 value in that study. Change from study AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Par.'s final visit in study AMB115811 was used as the entry visit of this extension study. For the Extension study, the visit schedule (Months 1, 3, 6, 9, 12 and 15) was mapped to the visit schedule (Months 5, 7, 10, 13, 16 and 19) for continuity with study AMB115811. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Intent-to-treat (ITT) Population: all par. who were randomized and took at least one dose of study medication in the double-blind phase (placebo or ambrisentan).|During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Meters||Inter-Quartile Range|Median
1343711|NCT01894022|Primary|Time to First Change in Dose of Open-label Ambrisentan Due to Tolerability Issues in Any Participant|The time to change in dose of ambrisentan or other targeted PAH (pulmonary arterial hypertension) therapeutic agents (prostanoids, PDE-5 inhibitors) due to tolerability issues (e.g. adverse events). Dosing data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first change in dose of open-label ambrisentan. This decision was documented in the reporting and analysis plan prior to database lock.|From the Entry visit of the extension study up to approximately 16 months|Safety (Extension) Population||||||
1343712|NCT01894022|Primary|Change From Study AMB115811 Baseline in Weight at the Indicated Time Points|Weight was measured at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and at end of study. Change from study AMB115811 Baseline in weight is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||kilogram (kg)||Inter-Quartile Range|Median
1343713|NCT01894022|Primary|Change From Study AMB115811 Baseline in Heart Rate at the Indicated Time Points|Vital signs including heart rate were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in heart rate is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||beats per minute||Inter-Quartile Range|Median
1343714|NCT01894022|Primary|Change From Study AMB115811 Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at the Indicated Time Points|Vital signs including SBP and DBP were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in SBP and DBP is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||millimeter of mercury (mmHg)||Inter-Quartile Range|Median
1343715|NCT01894022|Primary|Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit|Blood samples were collected at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study plus any unscheduled lab tests for creatinine. A creatinine value of potential clinical concern high was defined as >=176.8 micromoles per Liter. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study.|Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study plus any unscheduled lab tests (assessed up to approximately 16 months)|Safety (Extension) Population|||Participants|||Number
1343716|NCT01894022|Primary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern at Any Time Post Entry Visit|Blood samples were collected post Entry visit of the extension study and up to end of study for evaluation of the clinical chemistry parameters of alanine amino transferase (ALT), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), and total bilirubin. The clinical chemistry parameters of potential clinical concern high were defined as follows: ALT, AST, GGT >=3 times upper limit of normal (ULN); total bilirubin >=2 times ULN. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study.|Post entry visit of the extension study and up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Participants|||Number
1343728|NCT01893567|Primary|Subject Reported Target Lesion Severity Score.|Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.|2 weeks||||units on a scale||Standard Deviation|Mean
1344052|NCT01888367|Secondary|Change in Serum Creatinine Measurements From Baseline|Change from baseline in micromoles/liter|Within 4 days of surgery|"402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were as treated so patients randomized to gel but did not receive it in surgery were counted in the SOC group."|||micromoles/liter||Standard Deviation|Mean
1343717|NCT01894022|Primary|Change From Study AMB115811 Baseline in Red Blood Cell Count and Reticulocytes at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in red blood cell count and reticulocytes is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Tera per Liter (TI/L)||Inter-Quartile Range|Median
1343718|NCT01894022|Primary|Change From Study AMB115811 Baseline in Mean Corpuscle Volume at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in mean corpuscle volume is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Femtoliter (fL)||Inter-Quartile Range|Median
1343719|NCT01894022|Primary|Change From Study AMB115811 Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hematocrit is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Ratio||Inter-Quartile Range|Median
1343720|NCT01894022|Primary|Change From Study AMB115811 Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hemoglobin and MCHC is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Grams per Liter (g/L)||Inter-Quartile Range|Median
1343721|NCT01894022|Primary|Change From Study AMB115811 Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Absolute Neutrophil Count [ANC]), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelet count, and WBC count are summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Giga per Liter (GI/L)||Inter-Quartile Range|Median
1343722|NCT01894022|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Refer to the general AE/SAE module for a list of AEs and SAEs. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Safety (Extension) Population: all participants who enrolled and took at least one dose of study treatment during the extension study.|From entry visit of the extension study up to approximately 16 months|Safety (Extension) Population|||Participants|||Number
1343723|NCT01893905|Primary|Change in Pain According to VAS (0-100 mm)|VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).|24 weeks||||units on a scale||Standard Deviation|Mean
1343724|NCT01893879|Primary|Number of Participants With Incidence of Lymphedema|Participants were evaluated every 3 months up to one year post lymph node dissection|Up to 1 year||||Participants|||Count of Participants
1343725|NCT01893632|Primary|Abstinence From Benzodiazepine Use|Achievement of two weeks abstinence from benzodiazepine use at end of trial|last two weeks of 12 week trial||||Participants|||Count of Participants
1343726|NCT01893567|Secondary|Subject Reported Effectiveness Scores||2 weeks|||||||
1343729|NCT01893411|Secondary|Occurrence of TEAEs Leading to Discontinuation Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
1343730|NCT01893411|Secondary|Occurrence of TEAEs by Final Outcome Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
1343731|NCT01893411|Secondary|Occurrence of TEAEs by Worst Intensity Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
1343732|NCT01893411|Secondary|Occurrence of TEAEs Related to Treatment as Assessed by the Investigator Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
1343733|NCT01893411|Secondary|Occurrence of Serious TEAEs (TESAEs) Overall and Per Injection Cycle|Treatment-emergent Serious Adverse Events (TESAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
1343734|NCT01893411|Secondary|Occurrence of Participants With TEAEs of Special Interest (TEAESIs) Overall and Per Injection Cycle|Adverse Events (AE's) occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as AE's of Special Interests. Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
1343735|NCT01893411|Secondary|Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
1343736|NCT01893411|Secondary|Time to Reinjection for Each of the Three Dose Groups for the First and Second Injection Cycle||Baseline up to Week 24-72|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Weeks||Standard Deviation|Mean
1343737|NCT01893411|Secondary|Change in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) to All Post Baseline Visits of the First and of the Second Injection Cycle|"The QPS is a patient-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with 'Questionnaire on Pain caused by Spasticity [QPS]'. The QPS Total Score for pain intensity ranges from 0 ('No Hurt') to 10 ('Hurt Worst'). The QPS Total Score for the observed pain frequency ranges from 0 (Never) to 4 (Always).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343748|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to twelve months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted.||||||
1344103|NCT01887132|Other Pre-specified|Mullen Scales at 18 Months||18 months|||||||
1343738|NCT01893411|Secondary|Changes From Baseline in Gross Motor Function Measure [GMFM]-66 Score at the End of First Injection Cycle and at the End of Study Visit|"The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 12-36 of 1st IC and 2nd IC (End of study = Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343739|NCT01893411|Secondary|Investigator's Global Impression of Change of GICS-Plantar-Flexor of Primary Body Side at Day 29 (Week 4) of the First and Second Injection Cycle|"The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343740|NCT01893411|Secondary|Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale [GICS] at Day 29 (Week 4) of the First and Second Injection Cycle|"The Global Impression of Change Scales (GICS) are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343741|NCT01893411|Secondary|Changes From Baseline in Modified Tardieu Scale [MTS] of Plantar Flexors of Primary Body Side at Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12) of the First and of the Second Injection Cycle|"The Modified Tardieu Scale (MTS) assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a catch-and-release or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, i.e. the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, i.e. improvement of dynamic muscle spasticity.~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the model used for comparison and are therefore provided separately for each comparison."|Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Angle||Standard Error|Least Squares Mean
1343742|NCT01893411|Secondary|Changes From Baseline in AS Score of Knee Flexors or Thigh Adductors in Participants With Unilateral Treatment at Day 29 (Week 4) of the First and of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison.~KF = Knee Flexors; TA = Thigh Adductors; w = week."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343749|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to six months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted. Data for MSRE were collected for the two treated patients the primary endpoint is a comparison between the treatment groups. The two patients were in the same treatment group so a comparison between groups is not possible.||||||
1343743|NCT01893411|Secondary|Changes From Baseline in AS Score of Plantar Flexors of the Primary Body Side at Day 57 (Week 8) and Day 85 (Week 12) of the First and of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 8 and 12 of 1st IC and 2nd IC (Week 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343744|NCT01893411|Secondary|Change From Baseline in the AS Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and Week 16-40 resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343745|NCT01893411|Secondary|Change From Baseline in the AS Score of Plantar Flexors of the Nonprimary Body Side in Participants With Bilateral Treatment at Day 29 (Week 4) of the First (1st) and Second Injection Cycle (2nd IC)|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4 of 1st IC and Week 16-40 of 2nd IC|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343746|NCT01893411|Primary|Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle|"This variable is classified as co-primary to satisfy a Food and Drug Administration (FDA) request. The GICS-PF scale is a 7-Point Likert Scale for the assessment of the functional change due to treatment of plantar flexor spasticity only. Ranges from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
1343747|NCT01893411|Primary|Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC)|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. “primary body side” was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and Week 4 resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4|FAS population is subset in the SES for whom primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or investigator’s Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) [participants with bilateral treatment on same body side] at Day 29 [Week 4] of the 1st IC) were available.|||Units on a scale||Standard Error|Least Squares Mean
1344104|NCT01887132|Other Pre-specified|An Exploratory Analysis Will Investigate Whether Normalization of REM Parameters Also Improves Other Measurements of Sleep Quality in Children With Autism.||12 months|||||||
1343750|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax|Key PK parameters are shown for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1343751|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC|Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1343752|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level|"PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was very much better, a score of 4 indicated that the participant had experienced no change in energy level and a score of 7 indicated that the participant's energy level was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) * 100."|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I energy level questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for energy level collected from Day 15 through end of study.|||percentage of participants|||Number
1343753|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive|PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was “very much better,” a score of 4 indicated that the participant had experienced “no change” in sexual drive and a score of 7 indicated that the participant's sexual drive was “very much worse”. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) * 100.|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I sexual drive questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for sexual drive collected from Day 15 through end of study.|||percentage of participants|||Number
1343754|NCT01893281|Secondary|Change From Baseline in Serum Testosterone Levels|Serum testosterone levels were measured by LC/MS-MS.|Baseline, Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug with non-missing data at baseline and at least 1 post baseline measurement. Last-observation-carried-forward (LOCF) was used to impute missing data.|||ng/dL||Standard Deviation|Mean
1343755|NCT01893281|Primary|Percentage of Participants Achieving Normal Serum Testosterone Levels|Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) * 100.|Baseline through Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement.|||percentage of participants||95% Confidence Interval|Number
1343756|NCT01893203|Other Pre-specified|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.|1 week|One week after the first photodynamic therapy (PDT), seven patients had more severe reactions (erythema, crusting) at the site treated with BF-200 ALA, five patients had more severe reactions at the MAL site and one patient showed no difference between sites.|||participants|||Number
1343757|NCT01893203|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|3 months||||percentage of complete clearance|Participants|95% Confidence Interval|Number
1343758|NCT01893203|Secondary|Pain|"Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.~(treatment day). Of these values, the mean maximal pain is assessed."|12 hours|Patients|||units on a scale||Full Range|Mean
1343759|NCT01893203|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|0 (baseline) and 3 months|Punch biopsies bilaterally on treatment fields|||percentage of complete clearance|||Number
1343760|NCT01892865|Secondary|Complications: A Composite Endpoint of Death, Myocardial Infarction, Bleeding, Amputation|Comparison of the perioperative (30-day postoperative) composite endpoint of death, myocardial infarction, bleeding, amputation between the two study groups|Three years|Patients|||Participants|||Count of Participants
1343761|NCT01892865|Secondary|Operative Suite Personnel Job Satisfaction|Comparison of job satisfaction between study arms using three domains of the Maslach Burnout Inventory: Depersonalization (range 0-17, score of 17 indicates worse depersonalization). Emotional Exhaustion (range: 0-36, score of 36 is the worse). Personal accomplishment (range 1-60, score of 60 is best).|Three years|Health care providers|||units on a scale|Responses|Full Range|Mean
1343762|NCT01892865|Secondary|Difference in Throughput|Difference in total number of cases scheduled per unit of time analyzed between the two study arms|Three years|Operative days|||Operations/day analyzed|Operative Days||Number
1344105|NCT01887132|Secondary|REM Percentage at Baseline, 6, 12 and 18 Months|REM percentage is the percentage of sleep spent in REM|Baseline, 6, 12 and 18 months||||percentage of sleep|||Number
1343764|NCT01892709|Post-Hoc|"Mean Pain Intensity Score in Numerical Rating Scale (NRS) Units at Each Time Point, Based on Response to the Question, Do You Want More Pain Medication?"|"Pain intensity is measured on the numerical rating scale (NRS) with scores from 0 (no pain) to 10 (worst pain imaginable).~Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no at Time 1, Time 2 is 30 minutes later (at 1 hour), and for those who answer yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours"|4 hours||||units on a scale||Full Range|Mean
1343765|NCT01892709|Post-Hoc|"Number of Patients Responding to the Question, Do You Want More Pain Medication? at Each Time Point"|"Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no at Time 1, Time 2 is 30 minutes later (at 1 hour), and for those who answer yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours"|4 hours||||Participants|||Count of Participants
1343766|NCT01892709|Secondary|Adverse Events and Side Effects by Total Amount of Hydromorphone Received||120 min|Nausea and vomiting were only assessed as adverse events among patients who did not have nausea and vomiting before the study began|||Participants|||Count of Participants
1343767|NCT01892709|Primary|Number of Participants Requesting Pain Medication in Different Patterns Over Time|"This is a descriptive hypothesis-generating trial, which is why it is not being compared in a randomized fashion to a comparison group. We are examining extended titration by expanding our 1+1 protocol to a 1+1+1+1 protocol and the various patterns of opioid request. For example, some may state no every time they are asked Do you want more pain medication? Some will state yes each time, and others will answer yes and no at different time periods. We will report these various patterns (i.e. X participants answered no everytime they were asked, Y answered yes everytime they were asked, Z answered no twice, etc).~Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no, Time 2 is 30 minutes later (at 1 hour), and for yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours"|4 hours||||Participants|||Count of Participants
1343768|NCT01892657|Primary|Area of Erythema and Elevated Responses of Skin to Product|Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.|3 consecutive weeks||||participants|||Number
1343769|NCT01892306|Other Pre-specified|Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex|Resting state functional magnetic resonance imaging (rsfMRI) data (non-task, eyes opened) was acquired to investigate anterior insula and ventrolateral prefrontal cortex functional connectivity as a predictor of change on depression (HAM-D). See primary outcome description of HAM-D.|Six Months|Participating in the fMRI portion of the study was optional. A total of 15 participants consented to participate in fMRI portion (7 TAU+UP, 8 TAU). Data from all 15 subjects were analyzed.|||beta coefficient||Standard Error|Mean
1343770|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)|Neuroticism was assessed using the NEO Five Factor Inventory (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item Likert-type scale (1-5) calculated by summing scores for each subscale. Only the 15-item Neuroticism subscale is included in this study. See Baseline Characteristics for baseline NEO-FFI-N. See Primary Outcome Measure for description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
1343771|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)|Anxiety sensitivity, were assessed using the Anxiety Sensitivity Index, or ASI, a 16-item Likert-type scale (0-4) calculated by summing scores across items. See Baseline Characteristics for baseline ASI scores. See Primary Outcome Measures for a description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
1343772|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)|Reactions to emotions, were assessed using the Affective Control Scale, or ACS, a 42-item Likert-type scale (1-7) calculated by averaging scores across all items. See Baseline Characteristics for baseline ACS score. See Primary Outcome Measure for description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
1343773|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)|Emotion regulation skills were assessed using a measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items. See Baseline Characteristics for baseline DERS score. See Primary Outcome Measure for a description of HAM-A.|Six Months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
1343792|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute).|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1343774|NCT01892306|Secondary|Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)|The Client Satisfaction Questionnaire (CSQ) is an 8-item scale that assesses perceptions of acceptability and quality of outpatient treatment. Ratings are made on a 1 (poor) to 4 (excellent) scale for each item and then summed for a total score, with a minimum score of 8 and a maximum score of 32. Higher scores indicate greater satisfaction with treatment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||Units on scale||Standard Deviation|Mean
1343775|NCT01892306|Primary|Reductions Over Time in Depression Symptoms as Measured by Hamilton Depression Rating Scale (HAM-D)|The Hamilton Depression Rating Scale (HAM-D) is a well-validated clinician administered rating of depression-related symptoms. Scores are calculated by summing scores across all 17-items, with a minimum score of 0 and a maximum score of 54. Higher scores indicate greater impairment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||Units on scale||Standard Deviation|Mean
1343776|NCT01892306|Primary|Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale (HAM-A) is a well-validated clinician administered rating of anxiety-related symptoms. Ratings are made on a 0 (no symptoms) to 4 (most severe in frequency/duration/interference/distress) for each item (14 items), with a minimum score of 0 and a maximum score of 56 calculated by summing scores of all 14 items. Higher scores indicate greater impairment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||Units on scale||Standard Deviation|Mean
1343777|NCT01892293|Secondary|Peak Persistence of Modified T-cells in the Peripheral Blood|Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)|Days 1, 3, 5, 8, 15, 22, 29, 43, 101, 130 181, every 3 months thereafter|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with persistence data|||copies per μg of DNA||Full Range|Mean
1343778|NCT01892293|Secondary|Evaluate the Direct Anti-tumor Activity of NY-ESO-1ᶜ²⁵⁹T|Number of participants with response post-infusion as assessed by international uniform response criteria|180 days|Participants who received NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
1343779|NCT01892293|Primary|Adverse Events Related to Study Treatment|Number of Participants with NCI CTCAE Version 4.0 Adverse Events related to study treatment greater than or equal to Grade 3|Up to 12 months|Participants who received NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
1343780|NCT01892267|Secondary|Direct Cost|Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc)|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
1343781|NCT01892267|Secondary|Long-term Complications|Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention.|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
1343782|NCT01892267|Secondary|Short-term Complications|Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week.|One week||||participants|||Number
1343783|NCT01892267|Secondary|Gastrointestinal Quality of Life Index (GIQLI) Score|Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms|3 month|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that only 5 patients had a completed GIQLI questionnaire at 3-month follow-up.|||units on a scale||Full Range|Median
1343784|NCT01892267|Secondary|Difficulty of the Procedure|"Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being without difficulty and 10 being maximum difficulty.~The lower the score, the better the outcome."|Inra-procedural||||units on a scale||Standard Deviation|Mean
1343785|NCT01892267|Secondary|Time to Repeat Endoscopy for Tube Replacement|If repeate endocopy and tube placement are needed due to clogging or retrograde migration|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
1343786|NCT01892267|Secondary|Intervention Time|Time required from introduction of the upper endoscope until placement of the feeding tube.|Intra-procedural||||minute||Standard Deviation|Mean
1343787|NCT01892267|Secondary|Technical Success|Success of tube placement in the desired location as determined endoscopically.|Intra-procedural||||procedure|||Number
1343788|NCT01892267|Secondary|Patency of Feeding Tube|Determine tube patency which is defined as time period between tube placement and need for re-intervention.|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
1343789|NCT01892267|Secondary|Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration|Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement|4 weeks||||participants|||Number
1343790|NCT01892267|Primary|Number of Participants With PEG-J Tube Migration|Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.|From date of placement up to 4 weeks||||participants|||Number
1343791|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1346683|NCT01845831|Primary|Mean Blood Glucose Concentration After First Day of Treatment|The average blood glucose (BG) concentration after the first day of treatment|Duration of Hospitalization (Up to 10 Days)||||mmol/L||Standard Deviation|Mean
1343793|NCT01892189|Secondary|Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1343794|NCT01892189|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1343795|NCT01892189|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 M-I||Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
1343796|NCT01892189|Secondary|Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.|||hours||Full Range|Median
1343797|NCT01892189|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I)||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The pharmacokinetic (PK) analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1343798|NCT01892189|Primary|Ketamine-Induced Brain Activity in Regions of Interest During Resting State|Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32.|Day 1: 4 hours post TAK-063 dose or placebo|The pharmacodynamic (PD) analysis set included all participants in the safety set and with at least 1 valid PD assessment. PD analysis set did not include 2 participants treated with TAK-063 300 mg.|||percent signal change in brain activity||Standard Deviation|Mean
1343799|NCT01892163|Secondary|Proportion of Patients With Ocular and Systemic Serious Adverse Events||12 months||||participants|||Number
1343800|NCT01892163|Secondary|Difference Between Arms in Change in Central Subfield Thickness.|Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns|Baseline and 12 months|Few patients in both groups developed cataract. Due to the dense cataract, it was not possible to obtain the macular scans. Hence the discrepancy between the population who completed the study and the number for whom the OCT was obtained at exit visit.|||microns||Standard Deviation|Mean
1343801|NCT01892163|Secondary|Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).|"NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (lowest) to 100 (highest).~Composite score = (Score for each item with a non-missing answer) / Total number of items with non-missing answers 100 = Best, 0 = Worst possible score"|Baseline and 12 months|Though 48 patients completed the trial in the PRN arm, one patient did not complete the questionnaire completely, making it invalid for analysis. Hence the PRN arm number for this outcome was 47|||units on a scale||Standard Deviation|Mean
1343802|NCT01892163|Primary|The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months||Baseline and 12 months|Intention to treat analysis (available case)|||ETDRS letters||Standard Deviation|Mean
1343803|NCT01892020|Secondary|Incidence of AEs (Adverse Event)|Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.|||Events/100 years of patient exposure|||Number
1343804|NCT01892020|Secondary|Incidence of Hypoglycemic Episodes|Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.|||events per patient per year|||Number
1343805|NCT01892020|Secondary|The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile|Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Four (4) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||mmol/L||Standard Error|Least Squares Mean
1343806|NCT01892020|Secondary|2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile|PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Subjects were excluded from analysis due to lack of post-randomization measurements. See table.|||mmol/L||Standard Error|Least Squares Mean
1343807|NCT01892020|Secondary|­IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test|AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||min*mmol/L||Standard Deviation|Mean
1343808|NCT01892020|Secondary|­1-hour PPG Increment Following a Standard Meal Test|The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 8 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||mmol/L||Standard Deviation|Mean
1343809|NCT01892020|Primary|2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test|The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||mmol/L||Standard Deviation|Mean
1343810|NCT01891968|Primary|Overall Response (OR)|Primary outcome is overall response (OR) including hematologic improvement defined by International Working Group (IWG), complete remission, partial remission and marrow complete remission.|8 weeks||||Participants|||Count of Participants
1343811|NCT01891890|Other Pre-specified|Pediatric Inventory for Parents|"The Pediatric Inventory for Parents consists of 42 items involving communication, medical care, emotional disturbance, and change in role function. Parents respond to a list of difficult events (such as difficulty sleeping) that are often experienced by parents of children who are seriously ill. Parents indicated how frequently an event occurred by selecting 1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Very often. Raw score values range from 4 to 210 with higher scores indicating increased frequency of difficult events."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the Pediatric Inventory for Parents.|||units on a scale||Standard Deviation|Mean
1343812|NCT01891890|Other Pre-specified|Parenting Stress Inventory Short Form (PSI-4-SF)|The Parenting Stress Inventory-4-Short Form is a 36 item questionnaire, completed by the parent/guardian, designed to evaluate parenting and family characteristics based upon child characteristics (behavioral and emotional problems), parent characteristics, and situational/demographic life stress. Respondents indicate the degree to which they agree with a variety of statements by selecting 1=strongly agree, 2=agree, 3=not sure, 4=disagree, or 5=strongly disagree. Raw scores range from 36 to 180 and higher scores are associated with higher parental stress.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the PSI-4-SF.|||units on a scale||Standard Deviation|Mean
1343813|NCT01891890|Other Pre-specified|Pediatric Neuro-QOL Score|The Pediatric Neuro-QOL is a Quality of Life instrument developed in conjunction with NIH with a pediatric specific form utilized in this protocol. Pediatric Neuro-QOL assesses the domains of Anger, Anxiety, Cognition, Depression, Fatigue, Pain, Social Relations, and Stigma. Each domain has 8 to 10 items and respondents indicate how often they experienced feelings and circumstances related to each domain on a scale of 1 to 5 (such as 1=never, 2=almost never, 3=sometimes, 4=often, 5=almost always). Higher values indicate increased difficulty for most of the scales but this pattern is reversed for two of the domains. Raw scores are rescaled to standardized scores with a mean of 50 and a standard deviation of 10. Higher values for the standardized scores indicate more problematic characteristics while scores below 50 indicate that the child is experiencing less trouble in the domains measured by the Pediatric Neuro-QOL.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. This survey was completed by children aged 10 and older.|||t-scores||Standard Deviation|Mean
1343814|NCT01891890|Other Pre-specified|Affective Reactivity Scale|"The Affective Reactivity Scale is a 7-item survey completed by the child participants which asks questions concerning their level of agreement with statements about anger and irritability. Respondents select between not true (scored as 0), somewhat true (scored as 1), and certainly true (scored as 2). Total scores range from 0 to 14 with higher values indicating increased feelings of annoyance and anger."|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Affective Reactivity Scale.|||units on a scale||Standard Deviation|Mean
1343815|NCT01891890|Other Pre-specified|Youth Self Report||6 months|As this study was terminated early, the scoring algorithm was not programmed for this outcome measure.||||||
1343816|NCT01891890|Other Pre-specified|The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"Suicidal behaviors and suicidal ideation were assessed through an interview using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS guides interviewers to ask a series of simple questions in order to identify people at risk for suicide, as well as the severity and urgency of suicidal thoughts and behaviors. The Children's Baseline/Screening C-SSRS was used at the initial study visit while the Children's Since Last Visit C-SSRS was used for subsequent study visits. Any responses of yes to the C-SSRS questions are considered a positive response, indicating that the participant is experiencing thoughts of suicide or has exhibited suicidal behaviors."|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the C-SSRS.|||Participants|||Count of Participants
1343851|NCT01890967|Secondary|Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies||Baseline through Week 24|All randomized participants who received at least one dose of study treatment and had evaluable data.|||Participants|||Number
1343817|NCT01891890|Other Pre-specified|Grooved Pegboard|The Grooved Pegboard assesses fine motor speed and dexterity. The participant fits keyhole-shaped pegs into similarly shaped holes on a square board. The pegs, which have an edge along one side, must be rotated to match the holes before they can be inserted. The scores represent the number of seconds it took for the participant to correctly insert the pegs into the require number of grooves, using their dominant hand.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Grooved Pegboard task.|||Seconds||Standard Deviation|Mean
1343818|NCT01891890|Other Pre-specified|Symbol Digit Modalities Test|Symbol Digit Modalities Test (SDMT) is a test of graphomotor speed using numbers as the response rather than copying symbols, and is timed at 90 seconds. The SDMT is designed for people who are 8 years of age and older and detects brain dysfunction as well as measures function over time. Possible total scores range from 0 to 110; where 110 indicates that all values were entered within the 90 second limit. An increase between initial and retest scores indicates that the respondent is correctly matching numbers to symbols at a faster speed. The SDMT was administered at the Month 3 and Month 6 visits for this study.|Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Participants who were 8 years old or older were eligible to complete the Symbol Digit Modalities Test.|||number of correct responses||Standard Deviation|Mean
1343819|NCT01891890|Other Pre-specified|Story Memory|"Story Memory will be measured at baseline with the Children's Memory Scale (CMS) and then with the Wide Range Assessment of Memory and Learning-2 (WRAML-2) at the 6 month follow up visit. Two different tests are used to avoid practice effects in memory assessment associated with repeated assessments using the same stimulus material. The Story Memory sub-test of the CMS and the WRAML-2 Story Memory are measures of prose passage recall. Stories are read to the subject for recall, with different stories presented based upon participant age. Scores are converted to percentile ranks for both measurements of story memory. Possible scores can fall between the 1st and 99th percentile and higher values indicate better performance with story recall. Values between the 9th and 25 percentiles are considered low average, values between the 25th and 75th percentiles are average, while values between the 75th and 91st percentile are high average."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Story Memory measurement.|||percentiles||Standard Deviation|Mean
1343820|NCT01891890|Other Pre-specified|Wechsler Intelligence Scale for Children-IV Processing Speed|Coding and Symbol Search subtests from the Wechsler Intelligence Scale for Children (WISC)-IV are measures of processing speed and combine to form the Processing Speed Index. Processing speed refers to how quickly the child understands and responds to information. Coding presents children with a row of boxes containing a numeral in the top line and a symbol in the bottom line with the task of copying the symbol corresponding to each numeral as quickly as possible in 120 seconds. In Symbol Search, children are given rows of symbols and target symbols and are asked to mark whether or not the target symbols appear in each row as quickly as possible during 120 seconds. Composite scores compare the test-taker to peers with a mean score of 100 and a standard deviation of 15. Possible scores range from 40 to 160 with higher scores indicating increased processing speeds. Scores between 85 and 115 are considered average, with 2/3 of test takers falling between these values.|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the WISC-IV.|||units on a scale||Standard Deviation|Mean
1343821|NCT01891890|Secondary|Child Behavior Checklist|The Child Behavior Checklist is a measure of specific behavioral and emotional problems are rated by the child’s parent or guardian. The Child Behavior Checklist examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 118 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True). Total raw scores are converted to t-scores with a mean of 50 and standard deviation of 10. A t-score of 67 or greater is considered to be in the clinical range for problematic behavior.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Child Behavior Checklist.|||t-scores||Standard Deviation|Mean
1343822|NCT01891890|Primary|Conners' Continuous Performance Test II (CPT-II) Confidence Index|"The Conners’ Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter X. For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the CPT-II.|||Confidence Index||Standard Deviation|Mean
1343823|NCT01891864|Secondary|Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept|Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.|Week 52|The analysis was performed on immunogenicity set consisting of patients who provided data for ADA assessment of etanercept at baseline visit.|||percentage patients with positive ADA|||Number
1343824|NCT01891864|Secondary|Injection Site Reactions|Percentage of patients with injection site reactions up to Week 52|Week52|The analysis was performed on safety set including all patients who took at least 1 dose of study treatment|||percentage of patients with ISRs|||Number
1343852|NCT01890967|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
1343825|NCT01891864|Secondary|PASI 50, 75 and 90 Response Rates|Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders .|Week12|The analysis of this secondary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.|||percentage of patients|||Number
1343826|NCT01891864|Secondary|Percent Change From Baseline in PASI Score up to Week 12|The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups.|12 weeks|The analysis was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.|||percentage difference||Standard Error|Least Squares Mean
1343827|NCT01891864|Primary|PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept|The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.|Week 12|The analysis of the primary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.|||% of patients achieving PASI75 response|||Number
1343828|NCT01891734|Secondary|Client Satisfaction Questionnaire (CSQ-8)|The 8-item Client Satisfaction Questionnaire (CSQ-8) is rated on an 8-32 scale. Higher scores represent greater satisfaction with the intervention.|6 weeks||||units on a scale||Standard Deviation|Mean
1343829|NCT01891734|Secondary|Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score|The 12-item Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score is rated on a 0-100 scale. Higher scores represent better mental health functioning.|6 weeks, 12 weeks|These data include all participants who completed the 6-week follow-up assessment. Two participants from the PST-MF group did not complete the 6-week follow-up.|||units on a scale||Standard Deviation|Mean
1343830|NCT01891734|Primary|Depression Anxiety and Stress Scale (DASS)|The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse depression symptoms. The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse anxiety symptoms. The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse stress symptoms.|6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
1343831|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1343832|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1343833|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1343834|NCT01891669|Secondary|Overall Survival|Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.|Baseline to death|All enrolled participants|||pariticpants|||Number
1343835|NCT01891669|Secondary|Objective Response|Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment|||pariticpants|||Number
1343836|NCT01891669|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment|||pariticpants|||Number
1343837|NCT01891669|Secondary|Number of Participants With Positive Anti-PF-06263507 Antibody|The number of participants with positive anti-PF-06263507 antibody.|Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
1343838|NCT01891669|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
1343839|NCT01891669|Secondary|Number of Participants With Abnormalities in Urine Protein in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.|Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
1343840|NCT01891669|Secondary|Number of Participants With Chemistry Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
1343841|NCT01891669|Secondary|Number of Participants With Hematological Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
1343842|NCT01891669|Secondary|Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.|||participants|||Number
1343843|NCT01891669|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.|||participants|||Number
1343844|NCT01891669|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline up to Cycle 2 Day 1 (22 days)|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
1343845|NCT01891331|Primary|Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population|"For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following:~complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis;~any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis;~no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject."|4 weeks||||Participants|||Count of Participants
1343846|NCT01891305|Primary|Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population|For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.|6 weeks||||Participants|||Count of Participants
1343847|NCT01890967|Secondary|Number of Participants With an Injection Site Reaction||Baseline through Week 24|All randomized participants who received at least one dose of study treatment and had evaluable data.|||Participants|||Number
1343848|NCT01890967|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014||Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose|All randomly assigned participants who received at least one dose of the study medication and had evaluable data.|||μg∙hr/mL||Geometric Coefficient of Variation|Geometric Mean
1343849|NCT01890967|Secondary|Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
1343850|NCT01890967|Secondary|Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
1343853|NCT01890967|Secondary|Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]|Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage Change||Standard Error|Least Squares Mean
1343854|NCT01890967|Secondary|Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
1343855|NCT01890967|Secondary|Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C|LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
1343856|NCT01890967|Primary|Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)|Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.|Baseline, Week 16|Modified Intent to Treat (mITT) is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
1343857|NCT01890954|Primary|Percent of Time Spent Near Normoglycemia|Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).|8 hours||||percentage time near normoglycemia||Standard Error|Mean
1343858|NCT01890915|Other Pre-specified|Sweat Rate|To determine the change in sweat rate using QSweat methodology (WR TestWorks) from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Sweat collection capsules will be placed on the left lateral anterior shoulder, volar aspect of the distal forearm, proximal anterior thigh, and mid-lateral calf (dermatomes C5, T1, L3, L5) for measurement of sweat rate. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate after heat exposure.|2 hours||||Percent change||Standard Deviation|Mean
1343859|NCT01890915|Secondary|Cognitive Performance - Stroop Interference T-Scores|To determine the change in cognitive performance as measured by the Stroop Color and Word Interference T-Scores, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance from baseline (79 degrees) to warm exposure (95 degrees).|2 hours||||Percent change||Standard Deviation|Mean
1343860|NCT01890915|Primary|Core Body Temperature|To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained.|2 hours||||Percent Change||Standard Deviation|Mean
1343861|NCT01890785|Primary|Cmax for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours-post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
1343862|NCT01890785|Primary|AUC for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*h/ml||Standard Deviation|Mean
1343863|NCT01890785|Primary|Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
1343864|NCT01890785|Primary|Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*hr/ml||Standard Deviation|Mean
1343908|NCT01890577|Secondary|Number of Hospitalisations|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
1343909|NCT01890577|Secondary|Number of Red Blood Cell Transfusions|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
1346684|NCT01845792|Secondary|PSA Response|Prostate specific antigen (PSA) decline by 50% or more from baseline.|2 years||||Participants|||Count of Participants
1343865|NCT01890759|Secondary|Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®|Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, >39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.|Day 0 up to Day 7 post-each vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1343866|NCT01890759|Secondary|Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.|||Titer ratios||95% Confidence Interval|Geometric Mean
1343867|NCT01890759|Secondary|Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.|||Titer ratios||95% Confidence Interval|Geometric Mean
1343868|NCT01890759|Secondary|Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
1343869|NCT01890759|Secondary|Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
1343870|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343871|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343872|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343873|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343874|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343875|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343876|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343910|NCT01890577|Secondary|C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
1343877|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343878|NCT01890759|Primary|Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-second vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1343879|NCT01890746|Primary|Worst-case Post Baseline Change in Temperature Values From Baseline|The worst-case post Baseline high and low changes in temperature values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline was defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).|||Degrees Celsius||Standard Deviation|Mean
1343880|NCT01890746|Primary|Worst-case Post Baseline Change in Blood Pressure Values From Baseline|The worst-case post Baseline high changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the visit value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1343881|NCT01890746|Primary|Worst-case Change From Baseline in Pulse Rate Values|The worst-case post Baseline high and low changes in pulse rate values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline is defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles)|||Beats/minute||Standard Deviation|Mean
1343882|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status|The number of participants with worst case post-baseline changes (improved, no change, deteriorated) are presented.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and post-Baseline assessments.|||Participants|||Number
1343883|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values|The number of participants with worst case post-baseline changes (normal, abnormal - not clinically significant [NCS], abnormal - clinically significant [NS]) in ECG QT prolonged values are presented. The protocol does not define the criteria for normal, abnormal-NCS and abnormal CS ECG. The outcome was based solely on the investigator interpretation of ECG tracings.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||Participants|||Number
1343884|NCT01890746|Primary|Number of Participants With Liver Events.|The number of participants with liver enzyme (ALT, AST, ALP, Total bilirubin) abnormalities while receiving study treatment in each arm are presented.|8 weeks|Safety population|||Participants|||Number
1343885|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 or Grade 4 from their baseline grade are presented. Clinical Clinical Chemistry parameters included only lab tests that are gradable by CTCAE v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||Participants|||Number
1343886|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 (G3) or Grade 4 (G4) from their baseline grade are presented. Hematology parameters included only lab tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||Participants|||Number
1343887|NCT01890746|Primary|Change From Baseline in the Left Ventricular Ejection Fraction (LVEF).|LVEF is a measurement of the percentage of blood leaving heart each time it contracts. LVEF was assessed by an echocardiogram (ECHO) or Multiple Gated Acquisition scan (MUGA). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the Day 42 value minus the Baseline value.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and Day 42 LVEF measurements.|||LVEF percent||Standard Deviation|Mean
1343911|NCT01890577|Secondary|Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy|Due to the premature termination of the study no outcome measure data were analyzed.|At each 12-week interval over the observation period|||||||
1343912|NCT01890577|Secondary|Iron Therapy Use|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
1343913|NCT01890577|Secondary|ESA/Aranesp Dose Ratio|"Ratio of the calculated mean weekly dose equivalent of an ESA administered immediately prior to conversion to treatment with Aranesp, to the calculated mean weekly dose equivalent of the first dose of Aranesp administered at commencement. Not applicable to participants who were ESA-naive at time of Aranesp commencement.~Due to the premature termination of the study no outcome measure data were analyzed."|Day of commencement of Aranesp|||||||
1343914|NCT01890577|Secondary|Erythropoiesis Stimulating Agent (ESA) Usage|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
1343888|NCT01890746|Primary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) as a Measure of Safety and Tolerability.|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice|Safety population: all subjects who received at least one dose of investigational product.|||Participants|||Number
1343889|NCT01890694|Secondary|Tolerability of Diuretic Therapy|Improved ability to tolerate diuretic therapy, as evidenced by reduced adverse events to diuretic therapy and reduced risk of re-hospitalization.|Day 1 until Discharge (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343890|NCT01890694|Secondary|Neutrophil Function [Results From the Assay of Neutrophils]|Improved neutrophil function from baseline|Day 1 to Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343891|NCT01890694|Secondary|Survival|Improved chances of survival when receiving Tolvaptan vs. standard of care|Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343892|NCT01890694|Secondary|Hospital Readmission Rate|Lower readmission rate|Post-Discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343893|NCT01890694|Secondary|Renal Function [BUN and Creatinine Laboratory Results]|Improved renal function from baseline|Day 1 to Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343894|NCT01890694|Secondary|Ascites|Improved control of ascites|Day 1 to Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343895|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Months 2-6 post-discharge|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343896|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Week 1-4 Post-discharge|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343897|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|participants will be followed for the duration of hospital stay, an expected average of 2 weeks|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343898|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 8|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343899|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 6|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343900|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 4|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343901|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 2|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
1343902|NCT01890694|Primary|Length of Hospital Stay|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.|participants will be followed for the duration of hospital stay, an expected average of 2 weeks|Data were not collected due to premature termination of the trial||||||
1343903|NCT01890642|Secondary|Pain at J-tip Deployment|Pain when J-tip deployed assessed by video reviewers using pain scale. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|1 minute||||units on a scale||Inter-Quartile Range|Median
1343904|NCT01890642|Primary|Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture|"Pain score assessed by video reviewer at J-tip, J-tip noise or researcher approach (1 minute) and at venipuncture (3 minutes). The score at J-tip noise/researcher approach was subtracted from the score at venipuncture to give a number indicating the change in pain scores.~The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min||||units on a scale||Standard Error|Mean
1343905|NCT01890642|Secondary|Change in Pain Score From Baseline|"Pain score assessed by video reviewer before intervention (0 minute) and at venipuncture (3 minutes). The score at baseline was subtracted from the score at venipuncture to give a number indicating the change in pain scores.~The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min||||units on a scale||Standard Error|Mean
1343906|NCT01890642|Secondary|Fist Attempt Success|Proportion of patients where blood draw was successful on first attempt|up to 3 minutes||||participants|||Number
1343907|NCT01890642|Secondary|Pain Score|Pain score as assessed by video reviewers. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|At venipuncture (3 minutes)||||units on a scale||Inter-Quartile Range|Median
1343918|NCT01890512|Primary|Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit|"The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions.~Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:~no episodes of asystole,~no occurrence of sustained ventricular arrhythmias in the bore,~no loss of capture due to rise in pacing threshold."|one month||||number of MRI related patient adverse ev|||Number
1343919|NCT01890473|Secondary|Number of Participants With Blood Hematology, Chemistry Laboratory Values and Urinalysis Laboratory Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: lower limit of normal (LLN); upper limit of normal (ULN); pretreatment (preRX); cells per microliter (cµ/L); milligram per deciliter (mg/dL); milliequivalent (mEq): Hematology: leukocytes (*10^3 c/µL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; eosinophils (*10^3 cµ/L): if value >0.750*10^3 c/µL; lymphocytes (*10^3 cµ/L): if value <0.750*10^3 c/µL or if value >7.50*10^3 c/µL. Chemistry: blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; glucose (mg/dL): <65 mg/dL (low) or >220 mg/dL (high). Urine Blood, urine red blood cell (RBC), urine white blood cell (WBC): if missing PreRX use >= 2, or if Value >= 4, or if preRX = 0 or 0.5 then use >= 2, or if preRX = 1 then use >= 3, or if preRX = 2 or 3 then use >= 4.|Day 1 to 76 days post last dose|All treated participants with laboratory values were included in the safety analysis. n=number of participants evaluated.|||participants|||Number
1343920|NCT01890473|Secondary|Number of Participants With a Positive Immunogenicity Response Relative to Baseline|Blood samples were screened at baseline, Day 57 and Day 71 for the presence of drug-specific antibodies using Electrochemiluminescence (ECL). A positive immunogenicity response relative to baseline for Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4) and 'possibly immunoglobulin (Ig)’, and ‘Ig and/or Junction Region’, respectively, was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value. Baseline=Pre-dose value.|Day 57, Day 71|All treated participants with at least one post baseline immunogenicity result reported were included in the immunogenicity analysis. n=number of participants evaluated at the specific time point.|||participants|||Number
1343921|NCT01890473|Secondary|Number of Participants With Adverse Events of Special Interest|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Infections, Autoimmune Disorders, Malignancy, local site reactions, any AE occurring within 24 hours of SC injection. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.|||participants|||Number
1343922|NCT01890473|Secondary|Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Includes data Day 1 up to 76 days (71 days + 5 day window) post the single dose of study drug.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.|||participants|||Number
1343923|NCT01890473|Secondary|Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. V/F was measured in liters per kilogram body weight (L/kg)|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
1343924|NCT01890473|Secondary|Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. CL/F was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1343925|NCT01890473|Secondary|Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. T-HALF was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||h||Standard Deviation|Mean
1343926|NCT01890473|Secondary|Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. Tmax was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||h||Full Range|Median
1343927|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve From Time Zero to Extrapolated to Infinity, AUC (INF), of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. AUC (INF) was measured in μg*h/mL|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||μg*h/mL||90% Confidence Interval|Geometric Mean
1343928|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve (AUC) From Zero to the Last Time of the Last Quantifiable Concentration (0-T) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. AUC (0-T) was measured in μg*h/mL. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||μg*h/mL||90% Confidence Interval|Geometric Mean
1343929|NCT01890473|Primary|Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (μg/mL). Blood samples for pharmacokinetic (PK) parameters were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||μg/mL||90% Confidence Interval|Geometric Mean
1343930|NCT01890434|Secondary|Number of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI – Based on Blinded Readers' and Investigator's Assessment|Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.|0 to 30/40 min post-injection|FAS|||Participants|||Count of Participants
1343931|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT – Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with multi-vessel disease indicating significant CAD (defined as QCA stenosis of >=70%) as verified by SoR.|||Sensitivity %|||Number
1343932|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT – Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with single-vessel disease indicating significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %|||Number
1343933|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI – Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343934|NCT01890434|Secondary|Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis – Based on Blinded Readers' and Investigator's Assessment|Number of participants with myocardial perfusion defects on gadobutrol-enhanced CMRI was calculated in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%).|0 to 30/40 min post-injection|Participants in FAS with significant LMS stenosis indicating significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Participants|||Count of Participants
1344053|NCT01888367|Secondary|Number of Patients With Adverse Events||Within 30 days of surgery|"The safety analysis was as treated. For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group."|||participants|||Number
1343935|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading.|||Specificity %|||Number
1343936|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT – Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading,|||Specificity %|||Number
1343937|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI – Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.|0 to 30/40 min post-injection|Participants in FAS without significant CAD (defined as QCA stenosis of >= 50% by) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.|||Specificity %|||Number
1343938|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.|||Sensitivity %|||Number
1343939|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT – Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading performed.|||Sensitivity %|||Number
1343940|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI – Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery [LAD] / non-LAD / right coronary artery [RCA] / left circumflex artery [LCX]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of>=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR in each coronary territory.|||Sensitivity %|||Number
1343957|NCT01890421|Secondary|Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI – Based on Blinded Readers' and Investigator's Assessments|Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Percentage of Participants|||Number
1343941|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT – Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment|Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/(true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.|||Specificity %|||Number
1343942|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment|Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/(true negative + false positive). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT.|||Specificity %|||Number
1343943|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT – Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.|||Sensitivity %|||Number
1343944|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT – Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader (BR) and investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT.|||Sensitivity %|||Number
1343945|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images – Additional Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %|||Number
1343946|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images – Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %|||Number
1354002|NCT01745913|Secondary|Transplant-related Mortality (TRM), Relapse Rate, Survival and Progression Free Survival||estimation of 24 months to obtain survival info between subjects|Data were not collected||||||
1343947|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Specificity Based on Investigator’s Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343948|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Secondary Analysis of Specificity Based on Investigator’s Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343949|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Sensitivity Based on Investigator’s Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343950|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Secondary Analysis of Sensitivity Based on Investigator’s Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343951|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images – Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %|||Number
1343985|NCT01890148|Secondary|Summary Statistics for AUC0-4hrs on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for AUC0-4hrs on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)||||h*nmol/L||Standard Error|Geometric Mean
1343986|NCT01890148|Secondary|Summary for Change From Baseline for MMP-9 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis|||ng/ml||Standard Deviation|Mean
1343952|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images – Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %|||Number
1343953|NCT01890434|Primary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Specificity Based on Blinded Readers’ Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343954|NCT01890434|Primary|Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Primary Analysis of Specificity Based on Blinded Readers’ Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343955|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Sensitivity Based on Blinded Readers’ Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343956|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Primary Analysis of Sensitivity Based on Blinded Readers’ Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR, coronary angiography [CA] or computed tomography angiography [CTA, only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (full analysis set, included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343987|NCT01890148|Secondary|Summary for Change From Baseline for GRO-alpha by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set|||pg/ml||Standard Deviation|Mean
1343988|NCT01890148|Secondary|Summary for Change From Baseline for IL-8 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set|||pg/ml||Standard Deviation|Mean
1347023|NCT01841593|Primary|Amlodipine AUC(0-24h)|AUC0-24h: Area under the concentration time curve 24 hours in the absence, and presence, of raltegravir|Post-dose on day 7 of daily dosing||||ng*h/mL||95% Confidence Interval|Geometric Mean
1343958|NCT01890421|Secondary|Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated for detection of MPD on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
1343959|NCT01890421|Secondary|Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated for detection of myocardial perfusion defects (MPD) on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343960|NCT01890421|Secondary|Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis – Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR in the LMS.|||Participants|||Number
1343961|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Specificity %|||Number
1343962|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI – Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Specificity %|||Number
1343963|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
1343989|NCT01890148|Primary|Summary for Change From Baseline Neutrophil Cell Counts in Blood|Change from Baseline reflects the Day 2, Day 8, Day 15, Day 22, Day29 and Day 34 minus the baseline value|Baseline, Day 2, Day 8, Day 15, Day 22, Day29 and Day 34|PD Analysis|||10^9 cells/L||Standard Deviation|Mean
1343990|NCT01890148|Primary|Summary for Change From Baseline Neutrophils in Sputum|Change from Baseline reflects the Day 8, Day22 and Day29 minus the baseline value.|Baseline, Day 8, Day 22 and Day29|PD analysis set|||10^9 cells/L||Standard Deviation|Mean
1343964|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI – Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery [LAD] / non-LAD / right coronary artery [RCA] / left circumflex artery [LCX]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of>=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory(LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %|||Number
1343965|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images – Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment|Investigator’s assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator’s assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=70% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
1343966|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images – Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment|Investigator’s assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator’s assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=50% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %|||Number
1343967|NCT01890421|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Specificity Based on Investigator's Assessment|Investigator’s assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator’s assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=70% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343968|NCT01890421|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Secondary Analysis of Specificity Based on Investigator's Assessment|Investigator’s assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator’s assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=50% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343991|NCT01890148|Primary|Summary for Change From Baseline of Mean Global Semi-quantitative Score Values for Neutrophils in Bronchial Biopsies|"Change from baseline reflects the Week 4 value minus the baseline value. Baseline value is Day-14 measurement.~For semi-quantitative scores, 1= few number of Neutrophils, 2= moderate number of Neutrophils, 3= abundant of Neutrophils. For this end point the reduction in mean of semi-quantitative (arbitrary) scores indicates better result, i.e. lower numbers of Neutrophils.~The scores given for the biopsies taken at screening and end of treatment is the mean global semi-quantitative scores for the three compartments intraepithelial, subepithelial and submucosal."|Baseline and Week 4|PD analysis set|||Units on a scale||Standard Deviation|Mean
1343969|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343970|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI – Secondary Analysis of Sensitivity Based on Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343971|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images – Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
1343972|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images – Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %|||Number
1343973|NCT01890421|Primary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) – Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343992|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥2.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1344054|NCT01888367|Primary|Number of Patients With Surgical Site Infections||Within 30 days of surgery|The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.|||participants|||Number
1343974|NCT01890421|Primary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) – Primary Analysis of Specificity Based on the Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
1343975|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) – Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=70% for secondary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS: participants who underwent pharmacologic stress and for whom electronic case report form (eCRF) entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343976|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) – Primary Analysis of Sensitivity Based on Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 minute (min) post-injection|Full analysis set (FAS): participants who underwent pharmacologic stress and for whom electronic case report form entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
1343977|NCT01890343|Primary|Quantitative Amyloid Image Assessment|The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).|50-60 minutes after injection||||SUVr||Standard Deviation|Mean
1343978|NCT01890343|Primary|Qualitative Amyloid Image Assessment|Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.|50-60 min after injection||||participants|||Number
1343979|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Night Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (night time), by period (safety set).~The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.~One participant left the study on day 2, due to adverse event."|Up to 44 days||||Observations|Participants||Number
1343980|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Day Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (day time), by period (safety set).~The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.~One participant left the study on day 2, due to adverse event."|Up to 44 days||||Observations|Participants||Number
1343981|NCT01890148|Secondary|Number of Participants With Adverse Events|Summary of number of participants with adverse events (safety set)|Up to 40 days||||Participants|||Number
1343982|NCT01890148|Secondary|Number of Adverse Events|Summary of number of adverse events (safety set)|Up to 40 days||||adverse events|||Number
1343983|NCT01890148|Secondary|Summary Statistics for Cmax on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmax on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)||||nmol/L||Standard Error|Geometric Mean
1343984|NCT01890148|Secondary|Summary Statistics for Cmin on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmin on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)||||nmol/L||Standard Error|Geometric Mean
1343993|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1343994|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1343995|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥0.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1343996|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1343997|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.0%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1343998|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤6.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤6.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1343999|NCT01890122|Secondary|Change From Baseline in Body Weight at Weeks 12 and 26|Change in participant's body weight at Weeks 12 and 26 relative to baseline.|Baseline and Weeks 12 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."|||kg||Standard Deviation|Median
1344000|NCT01890122|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L).|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1344001|NCT01890122|Secondary|Percentage of Participants Requiring Hyperglycemic Rescue|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline.|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
1344002|NCT01890122|Secondary|Time to Hyperglycemic Rescue Event|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline. Time to hyperglycemic rescue was censored if the participant did not experience a hyperglycemic rescue event.|From the date of randomization through Week 26|Randomized set consisted of all enrolled participants who were randomized.|||days||Inter-Quartile Range|Median
1344003|NCT01890122|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26|The change between the FPG value collected at Weeks 4, 8, 12, 16, 20 and 26 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16, 20 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."|||mg/dL||Standard Deviation|Mean
1344018|NCT01889563|Primary|The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.|Patients underwent the assessments proposed in the study on an outpatient basis before and after 6 and 12 weeks of physical exercise training program. The primary end-point measure was the SD1, a nonlinear index of HRV that represent the parasympathetic modulation|baseline (before physical exercise training program), 6 and 12 weeks after intervention||||miliseconds||Standard Deviation|Mean
1344004|NCT01890122|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16 and 20|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1344005|NCT01890122|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.|Baseline and Week 26 (or Early termination)|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1344006|NCT01890031|Secondary|Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months|We will assess adherence (for those who are prescribed a statin in the moderate CVD risk group) by both indirect objective measures and subjective reports. The study design did not include prescription of a cholesterol-lowering medication as per randomization. Participants were prescribed a statin as standard of care based on the participants and physicians agreement. Low risk individuals have less need for medication compared to moderate risk based on the current science.|9 months||||participants|||Number
1344007|NCT01890031|Primary|LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants||9 months||||mg/dL||Standard Deviation|Mean
1344008|NCT01889797|Secondary|Progression Free Survival (PFS)|"CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm.~Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment."|Percent of participants alive and progression-free at 1 year||||percentage of participants||80% Confidence Interval|Number
1344009|NCT01889797|Secondary|Overall Response Rate|Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.|Baseline and Re-staging (week 12, 13 or 14)||||percentage of participants||80% Confidence Interval|Number
1344010|NCT01889797|Secondary|PET Response Rate|PET response rate [PET-documented CR + Partial Response (PR)] based on PET scan results. Patients with unevaluable disease were included in the denominator.|Re-staging (week 12, 13 or 14)||||participants|||Number
1344011|NCT01889797|Primary|Complete Response (CR) Rate|"Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab)~Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a >50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion >1.5cm in any axis or ≥50% increase in previously involved sites."|Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years|All participants were included in the analysis|||percentage of participants||80% Confidence Interval|Number
1344012|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo|Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2, Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring|||mg/dL||Standard Deviation|Mean
1344013|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting Serum Insulin|Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2. Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring|||mg/dL||Standard Deviation|Mean
1344014|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations|||mg/dL||Standard Deviation|Mean
1344015|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations|||mg/DL||Standard Deviation|Mean
1344016|NCT01889667|Primary|Evaluate the Safety and Tolerability of ORMD-0801.|Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug|Eight (8) days||||Number of Events|||Number
1344017|NCT01889563|Secondary|Walking Distance on Six Minute Walking Test|Patients underwent the assessments proposed in the study on an outpatient basis before physical exercise training program and after 6 and 12 weeks of physical exercise training program. The second end-point was walking distance on six minute walking test.|Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program||||meters||Standard Deviation|Mean
1344019|NCT01889420|Secondary|Overall Response Rate (RR)|"ORR is the percentage of patients with a > Partial Response (PR). Response is assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle.~Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.~PR: >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.~Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3 years|There was only one patient enrolled. Response rates cannot be accurately reported based on one patient.||||||
1344020|NCT01889420|Secondary|Anti-tumor Effect|"Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement.~Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.~Partial response (PR): >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.~Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3.5 years|There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.||||||
1344021|NCT01889420|Secondary|Toxicity Profile|The toxicity profile will be described by specific adverse event rates among patients experiencing > grade 3 hematologic events (lasting >7 days) or grades 3-5 non-hematologic adverse events, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. Specific events will be described as the numbers of patients experiencing them within each treatment cohort.|2 years|||||||
1344022|NCT01889420|Primary|Maximum Tolerated Dosage (MTD)(Phase I)|The Maximum Tolerated Dose (MTD) will be determined by first identifying the dose level at which >= 30% of patients experience a Dose Limiting Toxicity (DLT) according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. DLT will be defined based on the rate of drug-related grade 3-5, non-hematological adverse events experienced within the first 4 weeks (1 cycle) for each combined dosage scheme. The MTD will be defined as one dosage level below which DLT was observed in >= 30% of patients.|2 years|There was only one patient enrolled. The MTD could not be calculated based on one patient.||||||
1344023|NCT01889355|Primary|Enhanced Meter Feature Usability|The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).|4 weeks|All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system, and applicable regulatory requirements, shall be eligible to participate in the study|||Participants|||Count of Participants
1344024|NCT01889251|Primary|Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)|VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.|Day 28|This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.|||percentage of subjects|||Number
1344025|NCT01889238|Other Pre-specified|Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades|Laboratory tests included hematology parameters (low lymphocytes, WBC, neutrophils, hemoglobin and platelets) and chemistry parameters (mean albumin, Blood urea nitrogen [BUN], calcium, Lactate dehydrogenase [LDH], alanine aminotransferase, Aspartate aminotransferase , bilirubin, Alkaline phosphatase, creatinine and glucose). Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per National Cancer Institute Common Terminology Criteria (NCI CTC) (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
1344026|NCT01889238|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria: Systolic blood pressure (SBP):absolute SBP<90 millimeters of mercury (mmHg) and decrease from baseline (DFB)>30mmHg, absolute SBP>180mmHg and increase from baseline (IFB)>40 mmHg, final visit or 2 consecutive visits SBP>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP>=140mmHg, most extreme post- baseline SBP>=180mmHg, most extreme SBP>=140mmHg and>=20 mmHg CFB, most extreme SBP>=180mmHg and>=20mmHg CFB; diastolic blood pressure (DBP): absolute DBP>105mmHg and IFB>30mmHg, absolute DBP<50mmHg and DFB>20mmHg, final visit or 2 consecutive visits DBP>=15mmHg CFB, most extreme post-baseline DBP>=90mmHg, most extreme post-baseline DBP>=105mmHg, most extreme DBP>=90mmHg and>=15mmHg CFB, most extreme DBP>=105mmHg and>=15mmHg CFB; heart rate<50beats per minute (BPM) and DFB>20BPM or heart rate>120BPM and IFB>30BPM. Only those categories, in which at least 1 subject had data were reported.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
1344027|NCT01889238|Other Pre-specified|Number of Participants With Grade 3 or Higher Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. As per the NCI CTCAE, version 4.0, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death. Only the participants with treatment-emergent AEs of Grade 3 (severe) or higher grade were reported in this outcome measure.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
1344029|NCT01889238|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AEs was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 87 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
1344030|NCT01889238|Other Pre-specified|Trough Plasma Concentration of Enzalutamide and Its Metabolite,|M2 was the metabolite of enzalutamide. The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/ml) for enzalutamide and M2.|Predose on Day 1 (Baseline), Week 9 and Week 17|Pharmacokinetics (PK) analysis population included all participants who received 1 dose or partial dose of study drug, and who had at least 1 enzalutamide or M2 plasma concentration assessment.|||mcg/ml||Geometric Coefficient of Variation|Geometric Mean
1344031|NCT01889238|Secondary|Progression-Free Survival: ITT Population|PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.|||weeks||85% Confidence Interval|Median
1344032|NCT01889238|Secondary|Progression-Free Survival (PFS): Evaluable Population|PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.|||weeks||85% Confidence Interval|Median
1344033|NCT01889238|Secondary|Percentage of Participants With Best Objective Response: ITT Population|Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|Analysis was performed on participants from ITT population who had measurable disease.|||percentage of participants||85% Confidence Interval|Number
1344034|NCT01889238|Secondary|Percentage of Participants With Best Objective Response: Evaluable Population|Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|Analysis was performed on participants from Evaluable population who had measurable disease.|||percentage of participants||85% Confidence Interval|Number
1344035|NCT01889238|Secondary|Percentage of Participants With Clinical Benefit at Week 24: ITT Population|Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.|Week 24|ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.|||percentage of participants||85% Confidence Interval|Number
1344036|NCT01889238|Secondary|Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population|Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.|Week 24|Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.|||percentage of participants||85% Confidence Interval|Number
1344037|NCT01889238|Primary|Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population|Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.|Week 16|ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.|||percentage of participants||85% Confidence Interval|Number
1344038|NCT01889238|Primary|Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population|Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >= 16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference|Week 16|Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.|||percentage of participants||85% Confidence Interval|Number
1344039|NCT01888965|Secondary|Safety|Percent of subjects who experience grade 3/ 4 adverse events|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.|||percentage of participants|||Number
1344040|NCT01888965|Secondary|Progression-free Survival|"Time in days from study entry until disease progression or death~Disease progression was defined according to RECIST as at least a 20% increase in the sum of the longest diameter of the target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions"|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.|||days||Full Range|Median
1344041|NCT01888965|Primary|Biomarker Discovery|Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum|2 years|Data cannot be summarized in the data table because biomarker analysis did not take place after study closure due to insufficient number of samples to yield significant results related to dovitinib administration. Instead, collected samples are stored in our biobank, as consented by all patients, for future Oncological analyses of importance.||||||
1344042|NCT01888952|Primary|Total Number of Adverse Events.|Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade.|Average of 21 days.||||Adverse events|||Number
1344043|NCT01888900|Secondary|Rates of Asunaprevir and Daclatasvir Resistance||post treatment||||Participants|||Count of Participants
1344044|NCT01888900|Secondary|Virological Relapse|HCV RNA >= LLOQ level after therapy is stopped in a patient who previously achieved an end-of-treatment virological response|beyond Week 24 post treatment||||Participants|||Count of Participants
1344045|NCT01888900|Secondary|Serum Aminotransferase Levels|whether raw ALT value is in normal range which is less than 41 U/L.|Week 12 post treatment||||Participants|||Count of Participants
1344046|NCT01888900|Secondary|Sustained Virological Responder|sustained virological response at follow-up week 12|Week 12 post treatment||||Participants|||Count of Participants
1344047|NCT01888900|Secondary|End of Treatment Responder|end of treatment response (HCV RNA <LLOQ Target not Detected at week24)|Week 24 post treatment||||Participants|||Count of Participants
1344048|NCT01888900|Secondary|Extended Rapid Virological Responder|extended rapid virological response (HCV RNA <LLOQ Target not Detected at both weeks 4 and 12)|Both weeks 4 and 12 post treatment||||Participants|||Count of Participants
1344049|NCT01888900|Secondary|Rates of Rapid Virological Responder|rapid virological response (HCV RNA <LLOQ Target not Detected) at week 4|Week 4 post treatment||||Participants|||Count of Participants
1344050|NCT01888900|Primary|Changes in Interferon Stimulated Genes in the Liver|"Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression.~The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray."|baseline and either 2 or 4 weeks|one patient in genotype 1A arm was not included in primary outcome data collection due to late enrollment.|||relative expression||Inter-Quartile Range|Median
1344051|NCT01888367|Secondary|Cumulative ASEPSIS Score for Each Patient|Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.|Through post-operative Day 4|"Safety analyses were as treated so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized."|||units on a scale||Standard Deviation|Mean
1344057|NCT01888003|Secondary|Health-related Quality of Life|Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale|Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery|No subject data was analyzed.||||||
1344058|NCT01888003|Primary|Number of Subjects Requiring at Least One Blood Transfusion During Surgery.|The number of subjects who had blood transfusions (at least 1) during surgery|During surgery (less than 1 day)||||Participants|||Number
1344059|NCT01887990|Secondary|Depression|Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60|2 hours||||units on a scale||Standard Deviation|Mean
1344060|NCT01887990|Primary|Suicidality|"Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation.~Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide."|2 hours||||units on a scale||Standard Deviation|Mean
1344061|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived). Tablets Taken.|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) (study population measure statistically derived). Total number of tablets taken as reported by patient.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||Tablets||Standard Deviation|Mean
1344062|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived) - Patients Use|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) as reported by the patients. Patients who used any rescue medication during the study.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
1344063|NCT01887678|Secondary|Patients Achieving 100% Pain Relief|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 100% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment, however, the prevalence of 100% pain relief did not support an estimate for the median time. The number of patients who reached 100% pain relief is reported and the log rank test for difference in time to 100% pain relief was calculated for each injection.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
1344064|NCT01887678|Secondary|Time to 50% Pain Relief (Study Population Measure Statistically Derived)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 50% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||days||95% Confidence Interval|Median
1344065|NCT01887678|Other Pre-specified|Proportion of Patients Who Discontinued Due to an AE|Total number of patients affected.|All visits (Days 1 up to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. Medical Dictionary for Regulatory Activities (MedDRA) Version 16.0 terminology.|||participants|||Number
1344066|NCT01887678|Other Pre-specified|Incidence of Treatment Emergent Adverse Events (TEAEs)|Total number of patients affected.|during the treatment period and follow up period (Days 11 to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology. Adverse events during treatment (treatment-emergent) in 5% or more of total study patients|||participants|||Number
1344067|NCT01887678|Other Pre-specified|Each Adverse Event (AE)|Total number of patients affected.|Starting at Visit 2/ Start of Lead-In period (Day 7 up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. 8 patients without any injection (not randomized) reported 12 adverse events|||participants|||Number
1344068|NCT01887678|Other Pre-specified|Serious Adverse Events|Total number of patients affected.|Start of Lead-In period until individual study end, up to 16 weeks.|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology|||participants|||Number
1344069|NCT01887678|Secondary|Time to Walking (50-foot Walk Test)|Changes in time to walk 50 feet (seconds)|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||seconds||Standard Deviation|Mean
1354445|NCT01739361|Secondary|In-hospital Mortality|percent of patients who died in the hospital|Patients will be followed through the end of their hospital stay, an average of 5 weeks||||Participants|||Count of Participants
1344070|NCT01887678|Secondary|Pain Immediately Following the 50-foot Walk (100 mm VAS)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’.|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1344071|NCT01887678|Secondary|Physician Global Assessment (PhGA)|Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
1344072|NCT01887678|Secondary|Physician Global Assessment (PhGA)|Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
1344073|NCT01887678|Secondary|Patient Global Assessment (PGA)|Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
1344074|NCT01887678|Secondary|Patient Global Assessment (PGA)|Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages “Very good”, “Good”, “Fair”, “Poor” and “Very poor”.|from Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
1344075|NCT01887678|Secondary|Total WOMAC Score (All Subscales) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. A total WOMAC score was computed by averaging all 24 possible responses. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in total WOMAC score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1344076|NCT01887678|Secondary|Physical Function Bubscore (WOMAC Section C, Items #8-24) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess physical function, scores from WOMAC Section C, items 8 to 24 are averaged to yield the Physical Function Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in Physical Function subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1344077|NCT01887678|Secondary|Stiffness Subscore (WOMAC Section B, Items #6-7) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess stiffness, scores from WOMAC Section B, items 6 to 7 are averaged to yield the Stiffness Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in stiffness score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1344106|NCT01887132|Primary|Nonverbal Developmental Quotient (NVDQ)|"The Nonverbal Developmental Quotient (NVDQ) was calculated from the Mullen Scales of Early Learning scores by dividing the nonverbal mental age (average of the age equivalent value for the Visual Reception and Fine Motor scores) by the chronological age in months. The NVDQ is normalized to a mean score of 100, which indicates an average normal IQ. Less than 100 is a lower than average IQ. 2 standard deviations below average is considered impaired IQ (approximately lower than 70)."|Baseline and 12 months||||units on a scale|||Number
1344078|NCT01887678|Secondary|Pain Subscore (WOMAC Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in pain subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline to post-Baseline visits except End of Study Visit (up to day 105)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1344079|NCT01887678|Primary|Change in Knee Pain as Measured by the WOMAC Osteoarthritis (OA) Index Pain Subscale (Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to ‘None’ and 100 to ‘Extreme’. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. A two-sided test of equality of the study drug (Traumeel®-Zeel®) and Placebo at level 0.05 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the corresponding Baseline value of the primary efficacy variable as a covariate. The test decision was based on the (two-sided) p-value for the corresponding test of no treatment difference.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1344080|NCT01887470|Secondary|Colonic Methane Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||parts per million by volume||Full Range|Mean
1344081|NCT01887470|Secondary|Colonic Hydrogen Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||parts per million by volume||Standard Deviation|Mean
1344082|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications."|3 to 15 hours post last consumption|Of the 40 participants responding to the patient questionnaire, only 21 reported that they had had a previous colonoscopy; therefore, the other 19 are not included in this outcome measure.|||percentage of participants|||Number
1344083|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied Yes to this survey question."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||Percentage of Participants|||Number
1344084|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3|"Tolerability assessed by a patient questionnaire - Likert response to The dosing instructions were easy to understand and follow Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on Likert Scale||Standard Deviation|Mean
1344085|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2|"Tolerability assessed by a patient questionnaire - Likert response to I did not experience too much discomfort during the bowel prep Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on Likert Scale||Standard Deviation|Mean
1344086|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1|"Tolerability assessed by a patient questionnaire - Likert response to was regimen a tolerable bowel prep? Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on Likert Scale||Standard Deviation|Mean
1344107|NCT01886963|Primary|Wound Complication|breakdown, necrosis, erythema, infection, or dehiscence with location specified|12 Weeks||||participants|||Number
1344108|NCT01886937|Primary|Food Intake|The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration.|one week|This is a cross over design study. All participants received phentermine and placebo.The phentermine arm listed here includes all participants who received phentermine (regardless of whether they received it first or second). The placebo arm includes all those who received placebo (regardless of whether they received placebo first or second).|||kcal||Standard Deviation|Mean
1344087|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)|"A paper questionnaire contained a horizontal line 100 mm long with the right end labeled Best Possible Experience and the left end labeled Worst Possible Experience. The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation.~Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on VAS scale||Standard Deviation|Mean
1344088|NCT01887470|Secondary|Incidence of Treatment Failure|A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0.|at least 3 hours post last consumption|The study objectives in the protocol called for the incidence of treatment failures to be calculated from the pooled data of all treatment participants. Therefore, outcome measures are not displayed with respect to individual treatment groups.|||participants|||Number
1344089|NCT01887470|Primary|Efficacy of Lactulose as a Preparation for Colonoscopy.|"Efficacy assessed by the physician’s determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue.~The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility."|at least 3 hours post last consumption||||units on a scale||Standard Deviation|Mean
1344090|NCT01887418|Primary|The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks|The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST|||ng/dL||Standard Deviation|Mean
1344091|NCT01887418|Primary|The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks|The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST|||ng/dL||Standard Deviation|Mean
1344092|NCT01887418|Primary|The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks|The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST|||ng*hr/dL||Standard Deviation|Mean
1344093|NCT01887418|Secondary|Number of Patients in the PK Parameter Category|The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE|6 weeks||||participants|||Number
1344094|NCT01887353|Primary|Time to First Atrial Fibrillation (AF) Recurrence|There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead|up to 6 months||||participants|||Number
1344095|NCT01887288|Secondary|Combination Overall Clinical Benefit by RECIST 1.1|Assess the activity of this combination in terms of overall clinical benefit rates (CBR), including complete response (CR), partial response (PR) or stable disease (SD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|One year|data were not collected||||||
1344096|NCT01887288|Primary|Metronomic Capecitabine With Oral Digoxin|Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer|One year|data were not collected||||||
1344097|NCT01887171|Secondary|Postreperfusion Hyperfibrinolysis|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~Peripheral blood samples will be taken 15 min and 2 hours after portal reperfusion.~Hyperfibrinolysis will be diagnosed by Thromboelastometry (ROTEM) if one or more following criteria are met:~LI30<85% or ML>15% or LI60<85% or A10 in Extem is by 15% is less then A10 in Aptem."|15 min and 2 hours after portal reperfusion|||||||
1344098|NCT01887171|Secondary|Inflammatory Response to Reperfusion|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~After unclamping portal vein but before unclamping the inferior vena cava and after venting of first 100 ml of blood a 5 ml sample of blood (code is HV) from a tube inserted into caval suture line will be taken. Another 5 ml sample of blood (code is C) will be taken by puncture of one of hepatic veins 20 min later. Samples (5 ml each) of peripheral blood will be taken on 1st and 3d postoperative day (POD). P-selectin, interleukin-6, interleukin-8, tumor necrosis factor alfa (TNF-a) and macrophage inflammatory protein 1 alpha (MIP-1a) will be determined in samples HV and C. Interleukin-8, elastase, TNF-a and vascular endothelial growth factor (VEGF) will be determined in samples of 1st and 3d POD."|0 and 20 min after portal reperfusion, 1 and 3 postoperative day|||||||
1344099|NCT01887171|Secondary|Ischemic Reperfusion Injury of the Liver Allograft|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~A wedge resection of small (5x5mm) part of liver segment-III will be sampled at 2 hours after venous reperfusion. Rate of necrosis, inflammation, vascular thrombosis, cluster of differentiation (CD) 68 and High mobility group box 1 protein (HMGB1) staining will be assessed thereafter."|liver biopsy taken at 2 hours after portal reperfusion|||||||
1344100|NCT01887171|Primary|Early Allograft Dysfunction|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~Early allograft dysfunction will be assessed on the basis of highest levels of AST and ALT during 1-7 postoperative days."|1-7 postoperative days after liver transplant procedure||||Participants|||Count of Participants
1344101|NCT01887132|Other Pre-specified|Vineland Parent Questionnaire at 3, 6, 12 and 18 Months||3, 6, 12 and 18 months|||||||
1344109|NCT01886833|Other Pre-specified|Sero-epidemiology of Breakthrough Rotavirus Infection in Immunized Infants|"Determination of genotype in every rotavirus causing severe gastroenteritis will be done each time stool samples are collected for diarrhoea. Patients presenting with any diarrhoea will be tested for rotavirus and staged clinically (by Vesikari score). Those with severe disease (e.g., Vesikari >11/20) will be processed for genotype. Thus, we will identify the number of rotavirus cases following vaccination as well as identify the strain in those with severe disease.~This will allow for wild type versus vaccinestrain mismatch evaluation. We anticipate that the circulating strains in the community will change in response to vaccine pressure at the population level. However, when interpreting reasons for vaccine failure, it is critically important to evaluate strain mismatch because the way to approach this type of breakthrough disease is dramatically different than if there is breakthrough infection to vaccine strain rotavirus."|42 months|There were 81 episodes of diarrhoea from which samples were collected. 15 were positive for rotavirus by EIA|||stool samples|stool samples||Count of Units
1344110|NCT01886833|Secondary|Proportion of Immunized Infants With Low Micronutrient Levels (as Indicated by Serum Zinc and Vitamin A), Who Fail to Seroconvert|To evaluation whether nutritional status affects vaccine take, we will assess the immunized infant's nutritional status as indicated by serum level of zinc and vitamin A. These will be correlated to seroconversion results.|1 month after full immunization|Of the 216 infants with paired serum IgA at baseline and after 1 month of complete immunization, 164 had deficient micronutrients|||Proportion micronutritionally deficient|||Number
1344111|NCT01886833|Primary|Proportion of Immunized Infants Exposed to Maternal HIV Infection Who Fail to Seroconvert|To evaluate whether maternal HIV infection (as well as level of CD4 count) affects infant vaccine take, we will collect the maternal HIV status, (and CD4 count if +ve). We will then correlate the maternal HIC status and CD4 count levels to infant zero conversion at 1 month after the two vaccine doses.|1 month after the two vaccine doses|Of the 420 mothers, 125 were confimed HIV+|||Proportion of exposed infants|||Number
1344112|NCT01886833|Primary|Proportion of Immunized Infants Exposed to Transplacentally-acquired, Rotavirus-specific, Infant Serum IgG Who Fail to Sero-convert.|"The co-primary exposure in this cohort is transplacentally acquired anti-rotavirus immunoglobulin-G.~We will collect infant serum at baseline before any vaccination and then measure the levels of anti-rotavirus-specific serum IgG and will also obtain the same at 1 month following the second dose of Rotarix™ rotavirus vaccine."|1 month after full immunisation|We did not test the serum IgG collected at 1 month following the second dose of Rotarix™ rotavirus vaccine because all infants were seropositve at baseline||||||
1344113|NCT01886833|Primary|Proportion of Immunized Infants Exposed to High Breast Milk Anti-rotavirus Immunoglobulin-A Who Fail to Seroconvert|"The primary exposure in this cohort is maternal IgA status, as we believe breast milk IgA is the most critical factor in failed vaccination, and maternal IgA has previously been estimated to be either high level (approximately 55%) or undetectable or low level (approximately 45%).~We will collect maternal serum and breast-milk IgA at the time of vaccination and then measure infant anti-rotavirus-specific serum IgA levels 1 month following the second dose of Rotarix™ (GlaxoSmithKline) rotavirus vaccine."|1 month following full immunization|Of the 420 participants that were enrolled in the study, we had rotavirus specific paired IgA at baseline and post vaccination for 216 infants.|||Proportion of exposed infants|||Number
1344114|NCT01886807|Secondary|Blood Loss||At the completion of intubation|||||||
1344115|NCT01886807|Secondary|Intubation Duration||From start of intubation attempt to completion of intubation|||||||
1344116|NCT01886807|Secondary|Blood Pressure||From start of intubation attempt to completion of intubation|||||||
1344117|NCT01886807|Secondary|Heart Rate||From start of intubation attempt to completion of intubation|||||||
1344118|NCT01886807|Primary|Time to 1% Saturation Drop|Kaplan-Meyer estimate 25th percentile along with adjusted 95% confidence limits were reported instead of usual 50th percentile (median) since there was not enough non-censored data for the DLO2 group (not many patients dropped 1% in SO2 from their baseline )|From beginning to end of laryngoscopy||||seconds||95% Confidence Interval|Median
1344119|NCT01886807|Primary|Oxygen Saturation|In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome.|From start of intubation attempt to completion of intubation|||||||
1344120|NCT01886781|Primary|A Change in Abdominal Pain Severity|The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500|Total trial period 12 weeks||||units on a scale||Standard Deviation|Mean
1344121|NCT01886716|Primary|The Daily Drinking Questionnaire|The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)||||number of drinks||Standard Deviation|Mean
1344122|NCT01886716|Primary|Liebowitz Social Anxiety Scale|The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)||||units on a scale||Standard Deviation|Mean
1344153|NCT01885910|Secondary|Peeling|the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling|every four weeks|participants with data|||units on a scale||Standard Deviation|Mean
1344154|NCT01885910|Secondary|Dryness|the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
1344123|NCT01886690|Secondary|Change From Baseline in Uncorrected Visual Acuity in the Worse Eye|Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point|||Letters Read Correctly||Standard Deviation|Mean
1344124|NCT01886690|Secondary|Change From Baseline in the Schirmer Test in the Worse Eye|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point|||Millimeters in 5 minutes (mm/5 min)||Standard Deviation|Mean
1344125|NCT01886690|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point|||Seconds||Standard Deviation|Mean
1344126|NCT01886690|Secondary|Change From Baseline in Corneal Staining in the Worse Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
1344127|NCT01886690|Primary|Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale|The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 90|Per Protocol: all randomized patients who had no significant protocol violations|||Scores on a Scale||Standard Deviation|Mean
1344128|NCT01886313|Primary|Average Daily Pain Score|The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.|6 weeks|1 patient withdrew early from study|||units on a scale||Standard Deviation|Mean
1344129|NCT01886300|Secondary|Number of Participants With Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product|Up to 24 months|Participants present at the time of assessment were used for analysis.|||Number of participants|||Number
1344130|NCT01886300|Secondary|Incidence of Normalization of Serum Alanine Transaminase|Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
1344131|NCT01886300|Secondary|Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period|HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
1344132|NCT01886300|Secondary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period|HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
1344133|NCT01886300|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period|Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) ‘NEGATIVE’ or (b) a quantitative result was lower than the reported lower detection limit.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
1344134|NCT01886300|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period|A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
1344135|NCT01886300|Primary|Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment|HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|12 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
1344136|NCT01886300|Primary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|6 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
1344137|NCT01886287|Secondary|Rate of Progression Free Survival (PFS) at 6 Months|Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months. Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|At 6 months|Evaluable participants on study at 6 months||||||
1344138|NCT01886287|Primary|Number of Participants With Improved Frequency of Diarrhea|The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.|At 12 weeks|Participants on study at 12 weeks|||participants|||Number
1344139|NCT01886235|Secondary|Tumor Vasculature|Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.|Up to 2 months|Stringent dosing requirements precluded assessment of tumor vasculature endpoints. These measurements will be addressed in future studies.||||||
1344140|NCT01886235|Secondary|Percentage of Participants With Treatment Response|Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.|Up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1344141|NCT01886235|Secondary|Median Progression Free Survival|Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.|Up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1344142|NCT01886235|Secondary|Median Overall Survival|Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.|Up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1344143|NCT01886235|Secondary|Complication Rate|Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.|Up to 5 years|All treated and eligible patients|||Participants|||Count of Participants
1344144|NCT01886235|Secondary|Blood Flow Rates|Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.|Up to 2 months|All treated and evaluable patients. Only 7 patients had data available, one patient had an unobservable tumor and two patients the fluorscein never made it to the tumor.|||micrometers per second||95% Confidence Interval|Mean
1344145|NCT01886235|Secondary|"Percentage of Participants With Any Adverse Event"|Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.|Up to 5 years|All treated and eligible patients.|||percentage of participants||95% Confidence Interval|Number
1344146|NCT01886235|Primary|Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision|A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.|Up to 2 months|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1344147|NCT01885936|Secondary|Change in 6 Minute Walk Test|The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. Assessed by physical therapist.|Baseline, Week 6, and Week 52|Early participants were not randomized until 6 weeks; 3 drug and 2 placebo subjects could not be included in the analysis. One drug subject missed the Week 6 visit, and one placebo subject could not perform the 6 minute walk test. Later participants were unblinded before Week 52. Four drug and 3 placebo subjects could not be included at Week 52.|||meters||Standard Deviation|Mean
1344148|NCT01885936|Secondary|Change in Forced Vital Capacity From Pulmonary Function Tests at 30 Weeks and 52 Weeks.|FVC (forced vital capacity) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Week 30, and Week 52|One subject dropped out from the albuterol group. Later participants were unblinded and switched to drug before Week 52 under an IRB (Institutional Review Board) approved amendment, and 4 late-enrolled drug and 3 late-enrolled placebo subjects could not be included in the analysis at Week 52.|||Percent of predicted FVC||Standard Deviation|Mean
1344149|NCT01885936|Primary|Number of Participants With Adverse Events.|All participants who experienced adverse events.|52 weeks||||Participants|||Count of Participants
1344150|NCT01885910|Secondary|Burning|the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
1344151|NCT01885910|Secondary|Pruritis|the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
1344152|NCT01885910|Secondary|Oiliness|the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
1344157|NCT01885910|Secondary|Percentage of Participants Who Are Responders at Week 16 and 20|Responders is the percentage of participants who have an IGA <3 at Week 16 and 20|Assessed every 4 weeks, reported at weeks 16 and 20||||percentage of participants|||Number
1344158|NCT01885910|Secondary|Inflammatory and Non-inflammatory Lesion Counts||Every 4 weeks|participants with data|||lesions||Standard Deviation|Mean
1344159|NCT01885910|Primary|Percentage of Participants Who Remained Responders at Week 24|At week 12 responder had an IGA <3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained|Assessed every 4 weeks, reported at Week 24|only participants who were not lost to follow-up or did not withdraw consent were included in the final analysis|||percentage of particpants|||Number
1344160|NCT01885871|Secondary|Percent of Subjects With Post-treatment Adverse Event||During study duration 0-6 months.||||percent of participants|||Number
1344161|NCT01885871|Secondary|Mean Pain Score Associated With Laser Treatments|Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments.|During treatments||||units on a scale||Full Range|Mean
1344162|NCT01885871|Secondary|Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines|Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change.|12 weeks post- final treatment|Based on subject questionnaires, 90% of subjects reported improvement (clearing) in benign pigmented lesions at 12 weeks post- final treatment. Scores > or =1 indicate improvement.|||percent of participants|||Number
1344163|NCT01885871|Secondary|Percent of Participants With Improvement Score >/=1|Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores >/=1 indicate improvement.|12 weeks post- final treatment||||percent of participants|||Number
1344164|NCT01885871|Primary|Median VAS Improvement Score as Assessed by Blinded Physician Reviewers|Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.|12 weeks post- final treatment|Based on blinded photographic assessments of 20 subjects. Scores >/=1 indicate clearing.|||units on a scale||95% Confidence Interval|Median
1344165|NCT01885559|Secondary|Pain|Kidney pain (back or flank pain) experienced in since last visit|48 months|Cross sectional analysis at 48 months is reported only for those participants responding at that time point. Intention to treat analysis was used for in the modeling over time to incorporate all repeated measures.|||percentage of participants at 48 months||95% Confidence Interval|Number
1344166|NCT01885559|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis|||units on a scale per year||95% Confidence Interval|Mean
1344167|NCT01885559|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to Treat analysis|||units on a scale per year||95% Confidence Interval|Mean
1344168|NCT01885559|Secondary|Cardiovascular Hospitalizations|Cause-specific hospitalizations (cardiovascular)|up to 8 years|Intention to Treat analysis|||events|||Number
1344169|NCT01885559|Secondary|Hospitalizations|Hospitalization for any cause|up to 8 years|Intention to treat analysis|||events|||Number
1344170|NCT01885559|Secondary|Aldosterone|Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.|up at 8 years (annually assessed)|Intention to treat analyses|||annual percent change||95% Confidence Interval|Mean
1344171|NCT01885559|Secondary|Albuminuria|Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis|||annual percent change||95% Confidence Interval|Mean
1344172|NCT01885559|Primary|Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.||Patients followed for 5-8 years with average of 6.5 years follow up|Intention to Treat analysis was used for the primary outcome|||participants|||Number
1344173|NCT01885208|Secondary|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)|The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.|After 56 weeks' treatment|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||Participants|||Count of Participants
1344174|NCT01885208|Secondary|Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)|The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject’s treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||Units on a scale||Standard Error|Least Squares Mean
1345164|NCT01870076|Primary|Healing Touch Will Improve Total Sleep Time|Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.|8 hours||||minutes||Standard Error|Mean
1344175|NCT01885208|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure|Mean changes in systolic and diastolic blood pressure from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||mm Hg||Standard Error|Least Squares Mean
1344176|NCT01885208|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change in FPG from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||mg/dL||Standard Error|Least Squares Mean
1344177|NCT01885208|Secondary|Change From Baseline in Body Weight|Mean change in body weight from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||kilograms||Standard Error|Least Squares Mean
1344178|NCT01885208|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Mean change in HbA1c from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1344179|NCT01885117|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.|Day 1(baseline) through Day 22 postvaccination|Analysis was done on the safety set population|||Subjects|||Number
1344180|NCT01885117|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.|Day 1 through Day 4 postvaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records|||Subjects|||Number
1344181|NCT01885117|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/ Day 1|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
1344182|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if>40 % for adults aged 18 to ≤60 years and>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population|||percentages of subjects||95% Confidence Interval|Number
1344183|NCT01885117|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1344184|NCT01885117|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
1344185|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (Baseline)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1344233|NCT01884545|Secondary|Patient Activation Score|Patient activation is the degree to which patients accept an active role in their healthcare, and have the knowledge, skills and confidence to take care of their health. When scored as a continuous variable, the range is from 0 to 100, with higher numbers indicating greater levels of patient activation.|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
1344256|NCT01884519|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1344186|NCT01885117|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.|||Percentages of subjects||95% Confidence Interval|Number
1344187|NCT01885104|Primary|Number of Participants With Inflammation of the Esophageal Mucosa|Participants underwent endoscopic examination of the esophageal mucosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.|||Participants|||Number
1344188|NCT01885104|Primary|Number of Participants With Inflammation of the Oral Mucosa|Participants underwent visual examination of the oral muscosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.|||Particpants|||Number
1344189|NCT01885000|Secondary|Percentage of Subject Reporting a Treatment-related Adverse Event||From consent signature, up to Day 8|APT (All Patient Treated) population|||percentage of participants|||Number
1344190|NCT01885000|Secondary|Percentage of Participants With at Least One Grade Improvement in the Clinician's Erythema Assessment (CEA)|Percentage of participants with at least one grade improvement in the CEA|Day 1, 3 hour after drug application|Participantes with a CEA score at this timepoint|||percentage of participants|||Number
1344191|NCT01885000|Secondary|Facial Appearance Since Starting the Treatment|"Percentage of subjects who answered A lot better/A little better to the question what do you think about your facial appearance since starting the treatment?"|Day 8|Subjects who answered the questionnaire at Day 8|||percentage of participants|||Number
1344192|NCT01885000|Primary|Satisfaction With the Overall Study Treatment|Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment|Day 8|Subject who have answered the questionnaire at Day 8|||percentage of participants|||Number
1344193|NCT01884844|Primary|Change in Montgomery-Åsberg Depression Rating Scale|"Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts~Usual cutoff points are:~0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression."|baseline and at 12 week completion|Comparison of bimonthly scale measurements (MADRS, between treatment groups over time were done fitting individual Generalized Linear Models (GLMs) using the initial baseline measurement as an adjustment. Significance was fixed at 0.05%. SPSS v. 23 used|||units on a scale||95% Confidence Interval|Mean
1344194|NCT01884688|Primary|Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment|Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level|7 days||||Participants|||Count of Participants
1344195|NCT01884675|Secondary|Number of Participants With Testicular Function (Males Only) of Potential Clinical Concern Any Time Post Baseline|For male participants testicular function (total testosterone, sex hormone binding globulin [SHBG-calculated free testosterone), follicle stimulating hormone (FSH), luteinizing hormone (LH), and inhibin B were assessed at Weeks 4 and 16/early withdrawal. The testicular function data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including Testicular Function. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline, Weeks 4 and 16/early withdrawal|ITT Population||||||
1344196|NCT01884675|Secondary|Number of Participants With Hematology Parameters of Potential Clinical Concern Any Time Post Baseline|Hematology parameters including hemoglobin, international normalized ratio (INR), and platelet count assessed any time post Baseline. Baseline is the last value recorded on or prior to start of study treatment. For hemoglobin: lower concern value and high concern value was considered as <100 gram per liter (G/L) and none respectively. For INR: lower concern value and high concern value was considered as none or >5 prothrombin time respectively. For platelet count: lower concern value and high concern value was considered as <50 giga cells per liter (GI/L) and >500 GI/L respectively. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Participants|||Number
1344276|NCT01883986|Primary|Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months|Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1344197|NCT01884675|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern Any Time Post Baseline|Clinical chemistry parameters including alanine amino transferase (ALT), aspartate amino transferase (AST), creatinine, gamma glutamyl transferase (GGT) and total bilirubin (TB) assessed any time post Baseline. ALT: lower concern value and high concern value was considered as none and >=3xupper limit of normal (ULN) respectively. AST: lower concern value and high concern value was considered as none or >=3xULN respectively. creatinine: lower concern value and high concern value was considered as none and >=176.8 micromoles per liter (umol/L) respectively. GGT: lower concern value and high concern value was considered as none and >=3xULN respectively. For TB: lower concern value was none and high concern value was >=2xULN. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal,|ITT Population|||Participants|||Number
1344198|NCT01884675|Secondary|Change From Baseline in Heart Rate Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including heart rate at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||beats per minute||Inter-Quartile Range|Median
1344199|NCT01884675|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including supine systolic and diastolic blood pressure at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Supine blood pressure measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||millimeter of mercury (mmHg)||Inter-Quartile Range|Median
1344200|NCT01884675|Secondary|Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal|A significant liver chemistry result is defined as any result which met the stopping criteria defined in the study protocol. Liver events were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Number of participants who reported a significant liver chemistry result are presented.|Weeks 4, 8, 12, and 16/Early Withdrawal|ITT Population|||Participants|||Number
1344201|NCT01884675|Secondary|Change From Baseline in Haematocrit Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haematocrit levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Proportion of 1||Inter-Quartile Range|Median
1344202|NCT01884675|Secondary|Change From Baseline in Haemoglobin Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haemoglobin levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Grams per liter||Inter-Quartile Range|Median
1344203|NCT01884675|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment and until follow up (Week 16/Follow up)|ITT Population|||Participants|||Number
1344204|NCT01884675|Secondary|Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. The SF-36 data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including the SF-36. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline and up to Week 16/Early Withdrawal|ITT Population||||||
1344277|NCT01883908|Primary|Number of Patients Completing Acupuncture Treatment|Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.|16 weeks|Zero participants analyzed due to early termination of study.||||||
1344278|NCT01883908|Primary|Side Effects of Acupuncture Treatment|All acupuncture side effects will be recorded|16 weeks|Zero participants analyzed due to early termination of study.||||||
1344205|NCT01884675|Secondary|Percent Change From Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The ratio to baseline [BL] in NT-proBNP was calculated as the ratio of the value at the specified time-point to the BL value and was expressed as a percent change from BL. For each treatment group, the mean change from BL at the specified time-point was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the value at the specified time-point to BL on the original scale. The GM was expressed as a percentage (100*[GM – 1]). Standard Deviation(SD) is the SD of the mean change from baseline values on the log scale.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Percent change||95% Confidence Interval|Geometric Mean
1344206|NCT01884675|Secondary|Change From Baseline in Cardiac Index at Week 16|Cardiac index is measure of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint were summarized.|||Litre per minute per meter squared||Inter-Quartile Range|Median
1344207|NCT01884675|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) and Mean Pulmonary Artery Pressure (mPAP) at Week 16|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Millimeter of mercury (mmHg)||Inter-Quartile Range|Median
1344208|NCT01884675|Secondary|Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Clinical worsening of CTEPH is defined by the time from randomization to the first occurrence of death, lung transplantation, hospitalization for CTEPH, atrial septostomy, addition of parenteral prostanoids, or study withdrawal due to two or more early escape criteria included: a decrease from Baseline of at least 20 percent in the distance walked during the six-minute walk test; an increase of one or more WHO functional class; worsening right ventricular failure (e.g., as indicated by increased jugular venous pressure; new/worsening hepatomegaly, ascites, or peripheral edema; worsening echocardiographic parameters such as tricuspid annulus plane systolic excursion (TAPSE) and Tissue Doppler Imaging of the tricuspid annulus); rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (systolic blood pressure less than 85 millimeter of mercury [mmHg]).|From randomization to Week 16/Follow up visit (21 weeks)|ITT Population|||Participants|||Number
1344209|NCT01884675|Secondary|Change From Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at Weeks 4, 8, 12 and 16/Early Withdrawal|The BCR10S score was collected immediately following completion of the 6-minute walk test. Baseline data was calculated as the average of the two BCR10S values obtained following the two 6MWD tests used in determining the Baseline 6MWD. If only one measurement was available, that measurement has been used. BCR10S scores ranges from 0 to 10 (0=nothing at all, 10=extremely strong). If participant's perception or feeling was stronger than ”10”, i.e “extremely strong”, “Maximal” – a larger number could be used, e.g. 12 or still higher i.e “Absolute maximum”). Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Scores on a scale||Inter-Quartile Range|Median
1344210|NCT01884675|Secondary|Change From Baseline in WHO Functional Class (FC) at Weeks 4, 8, 12 and 16/Early Withdrawal|The WHO FC indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. For analyse purposes, the WHO FC Class categories of I-IV were mapped to a numeric scale of 1-4.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Scores on a scale||Inter-Quartile Range|Median
1344211|NCT01884675|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16|PVR is a measure of cardiopulmonary haemodynamics. Change from Baseline was calculated as value at specified visit minus Baseline value. Baseline is the last value recorded on or prior to start of study treatment.|Baseline (Week 0) and Week 16|ITT Population. Only those participants with available data at Baseline and the specified timepoint were analysed.|||Dynes*second/centimeter^5||Inter-Quartile Range|Median
1344234|NCT01884545|Secondary|Perceived Risk for Type 2 Diabetes (T2D)|Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding T2D risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
1346184|NCT01853176|Primary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.|3 days|||||||
1344212|NCT01884675|Primary|Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16|The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Change from baseline was calculated at Weeks 4, 8, 12 and 16. Change from Baseline was calculated as value at the specified visit minus the Baseline value. Data at Baseline is based on average of two consecutive test results during Screening/Baseline period that differ by <10%. If only one measurement was available, that measurement was used. In any cases where the protocol-defined criteria for Baseline 6MWD was not met, the Baseline value was based on the last two consecutive measurements for a participant.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Meters||Inter-Quartile Range|Median
1344213|NCT01884597|Secondary|Fundus Clinical Findings|Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam|Baseline, Months 6, 12, 24||||Participants with Fundus Findings|||Number
1344214|NCT01884597|Secondary|PCV Anatomic Changes|"Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography~Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography"|Baseline, Months 6, 12, 24||||Participants with PCV Anatomic Changes|||Number
1344215|NCT01884597|Secondary|Macular Edema|Optical Coherence Tomography (OCT) central macular and peripapillary thickness|Baseline, Day 14, Month 1-24|Patient in Cohort 2 missed several visits.|||microns||Standard Deviation|Mean
1344216|NCT01884597|Secondary|BCVA|Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24|at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24||||number of letters read correctly||Standard Deviation|Mean
1344217|NCT01884597|Secondary|Systemic AEs|Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs|Monthly||||Number of Participants with Systemic AEs|||Number
1344218|NCT01884597|Secondary|Ocular Adverse Events (AE)|Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)|Monthly||||Ocular adverse events|||Number
1344219|NCT01884597|Primary|BCVA|Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24|Baseline to M24||||number of letters read correctly||Standard Deviation|Mean
1344220|NCT01884597|Primary|BCVA|Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.|From Baseline to Month 12||||number of letters read correctly||Standard Deviation|Mean
1344221|NCT01884571|Secondary|Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)|Blood was drawn and banked for future use in order to characterize immune system markers and further the understanding of the immune factors that contribute to disease progression in ALS.|Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6), Post-Treatment Period (Months 8 and 12)|Blood was collected for all 31 participants and banked for future use.|||Participants|||Count of Participants
1344222|NCT01884571|Secondary|Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels|Lumbar punctures (LPs) were performed to collect cerebrospinal fluid (CSF). CSF is banked for future use to characterize immune system markers and to further the understanding of the immune factors that contribute to disease progression in ALS. Cytokines are markers of neuroinflammation and can be categorized as neurotoxic or neuroprotective. The role that cytokines play in in ALS progression is still not yet fully understood.|Pre-Treatment Period (two months prior to the start of treatment), Treatment Period (Months 2 and 6), Post-Treatment Period (Month 12)|Cerebrospinal fluid was collected from 29 participants and banked for future analysis.|||Participants|||Count of Participants
1344223|NCT01884571|Secondary|Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment|Blood was collected for ribonucleic acid (RNA) and the mean rate of decline of T-cells during the 6 month treatment period compared to the pre-treatment period was assessed (blood was collected twice during the 3-month long lead in period). The precise role that T-cells have in ALS is unknown and this study aims to further the understanding of how T-cells operate in persons with ALS. T-cell measurement is a ratio where the relative expression levels of FOXP3 messenger ribonucleic acid (mRNA) was calculated using the Comparative CT Method (ΔΔCT Method), normalizing to β-actin. Samples were obtained during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in T-cells over time.|Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6)||||fold change per month||Standard Error|Mean
1344224|NCT01884571|Secondary|Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment|Hand grip was measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles. The grip strength of the left and right hands were analyzed together. Grip strength was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. Grip strength is a measurement of muscle strength and declines as ALS progresses. A positive value means that scores during treatment were higher than pre-treatment scores, indicating an increase in grip strength over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)||||pounds change per month||Standard Error|Mean
1344225|NCT01884571|Secondary|Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment|Hand held dynamometry (HHD) is a measure of muscle strength and scores decrease as ALS progresses. Six proximal muscle groups were examined bilaterally in both upper and lower extremities. Mean and standard deviation for each muscle group are established from the initial values for each participant. Strength determinations were converted to Z scores and averaged to provide an HHD megascore. The Z-score indicates the number of standard deviations away from the mean of 0. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. HHD was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in strength over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early.|||z-score change per month||Standard Error|Mean
1344226|NCT01884571|Secondary|Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment|Vital capacity (VC), percent of predicted normal, was determined using the slow VC method. SVC measures the amount of air exhaled following a deep breath. For this test, participants hold a mouthpiece in their mouth, breathe in deeply, and breathe out as much air as they can. The test was done seated in a chair and then repeated while lying on an exam table at the Screening Visit. For all other visits, this test was done while seated in a chair. This test takes 15-20 minutes. SVC was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. SVC is a way to measure respiratory insufficiency in persons with ALS and SVC decreases as ALS progresses. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure.|||percent predicted change per month||Standard Error|Mean
1344227|NCT01884571|Secondary|Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment|The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability). ALSFRS-R was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in ability over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early (available ALSFRS-R scores were used)|||units on a scale change per month||Standard Error|Mean
1344228|NCT01884571|Primary|Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month|The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response is defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early (available ALSFRS-R scores were used).|||Participants|||Count of Participants
1344229|NCT01884545|Secondary|Social Isolation|Single item to assess for availability of support person, where No=no support person.|6 months|Data is reported for participants who had data available at the 6 month visit. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.|||Participants|||Count of Participants
1344230|NCT01884545|Secondary|Unmanaged Stress as Measured by the Perceived Stress Scale (PSS)|The PSS is a 10 item survey assessing feelings and thoughts of stress. Scores range from 0-40 with higher scores indicating higher perceived stress.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
1344231|NCT01884545|Secondary|Depression, as Measured by the Beck Depression Inventory (BDI)|The Beck Depression Inventory is a 21-item measure that assesses self-reported symptoms of depression. It has been heavily used in research linking depression to heart disease. Scores range from 0-63, with 0 = minimal depression and 63 = severe depression.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
1344232|NCT01884545|Secondary|Stages of Change|These evidence-based questions are validated and based upon the Transtheoretical Model and assess an individual’s readiness to make behavioral change in 5 health behavior domains (dietary intake, exercise, weight loss, smoking cessation, and medication adherence).|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||Participants|||Count of Participants
1346185|NCT01853085|Primary|IOP in the Study Eye at Week 12|IOP is a measurement of the fluid pressure inside the study eye.|Week 12|All patients with data for this outcome measure|||mmHg||Standard Deviation|Mean
1344235|NCT01884545|Secondary|Perceived Risk for Coronary Heart Disease (CHD)|Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding CHD risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
1344236|NCT01884545|Secondary|Diabetes Risk Score||12 months|risk score data was only collected and calculated at baseline||||||
1344237|NCT01884545|Secondary|Framingham Risk Score (FRS)||12 months|risk score data was only collected and calculated at baseline||||||
1344238|NCT01884545|Secondary|AF Composite Fitness Scores|Last annual fitness exam result, collected as pass or fail|12 months|Data only collected on active duty participants as part of their annual assessment. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.|||Participants|||Count of Participants
1344239|NCT01884545|Secondary|Total Cholesterol|Adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
1344240|NCT01884545|Secondary|Body Mass Index (BMI)||12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||kg/m2||Standard Deviation|Mean
1344241|NCT01884545|Secondary|Fasting Blood Glucose|Adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
1344242|NCT01884545|Primary|Triglycerides|Triglycerides in mg/dL|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
1344243|NCT01884545|Primary|Low-density Lipoprotein (LDL)|Low-density lipoprotein (LDL) in mg/dL|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
1344244|NCT01884545|Primary|High-density Lipoprotein (HDL)|High-density lipoprotein (HDL) in mg/dL|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
1344245|NCT01884545|Primary|Diastolic Blood Pressure|Diastolic blood pressure in mmHg|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mmHg||Standard Deviation|Mean
1344246|NCT01884545|Primary|Systolic Blood Pressure|Systolic blood pressure in mmHg|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mmHg||Standard Deviation|Mean
1344247|NCT01884545|Primary|Waist Circumference|Waist circumference in cm|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||cm||Standard Deviation|Mean
1344248|NCT01884545|Primary|Weight|Weight in kg|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||kg||Standard Deviation|Mean
1344249|NCT01884545|Primary|Medication Adherence as Measured by Morisky Adherence Survey MMAS8|Scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score between 6 < 8 medium adherence and a score of 8 high adherence.|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
1344250|NCT01884545|Primary|Smoking Status||12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.|||Participants|||Count of Participants
1344251|NCT01884545|Primary|Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)|The Stanford Brief Activity Survey is a 2-item survey that assesses two categories of physical activity – work and leisure. There are five options for degree of activity to choose from in each of the two areas of activity. Activity categories (inactive, light-intensity activity, moderate-intensity activity, hard-intensity activity, and very hard-intensity) are represented in a table of different patterns. Degree of work activity is represented on the vertical axis and degree of leisure activity is represented on the horizontal axis. The overall activity level category is determined by where the two responses intersect.|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.|||Participants|||Count of Participants
1344252|NCT01884545|Primary|Dietary Intake as Measured by Daily Grams of Fiber|Dietary intake as measured by daily grams of fiber, adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||grams||Standard Deviation|Mean
1344253|NCT01884545|Primary|Dietary Intake as Measured by Percent Energy From Fat|Dietary intake as measured by percent energy from fat, adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||percent energy from fat||Standard Deviation|Mean
1344254|NCT01884519|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344255|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344257|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344258|NCT01884519|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1344259|NCT01884519|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344260|NCT01884519|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1344261|NCT01884519|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344262|NCT01884519|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344263|NCT01884519|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1344264|NCT01884519|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344265|NCT01884519|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1344266|NCT01884519|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344267|NCT01884519|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344268|NCT01884519|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1344269|NCT01884064|Primary|Cortical Silent Period|Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.|Baseline and Day 5||||milliseconds||Standard Deviation|Mean
1344270|NCT01883999|Secondary|Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)|Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria|||participants|||Number
1344271|NCT01883999|Primary|Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC|"Freedom from all of the following:~Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).~Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory~Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC."|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria|||participants|||Number
1344272|NCT01883999|Primary|Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair|Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.|30 days post-treatment|Subjects initiating IBE procedure and meeting inclusion/exclusion criteria|||participants|||Number
1344273|NCT01883986|Secondary|Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months|Clinician knowledge of patient preferences for life sustaining treatments will be assessed at baseline and at the study end point by asking 2 validated questions to both the clinician and the patient and determining the level of agreement between the responses.|Baseline and 3 months|No data was collected due to poor provider response to surveys.||||||
1344274|NCT01883986|Secondary|Change in Baseline Quality of Clinician Communication at 3 Months|"The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).The QOC consists of 13 items divided into two subscales, six general communication items and seven end-of-life topics. We analyzed the six-item general communication skills scale, which scores range from 0-10. The higher the score the better the provider's communication is. We asked patients to answer the questions in reference to the provider who was primarily responsible for managing their lung cancer."|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1344275|NCT01883986|Secondary|Change From Baseline in Patient Satisfaction of Care at 3 Months|Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total scores are reported (no subscales). The total scores range from 13-65 with scores of 52 > indicating satisfaction with care. The higher the score the better the outcome (better satisfaction with care). In full randomized clinical trials, the estimated minimal important difference is 5 points from baseline to 12 weeks.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1344411|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Quality of Life|At month 4 of the study, and every 3 months therafter for 12 months, the subjects will complete standardized questionnaires on quality of life, focusing on general well being, mood, pain, and sleepiness.|Months 4-16|||||||
1344279|NCT01883895|Secondary|Pain Threshold|Subjects will press a button attached to a timer out of view of the subject when the pressure stimulus first becomes painful. This will utilize a protocol recognized as a validated measurement of pain threshold.|We will monitor the subject's reported pain thresholds during the two minute interval that the pressure stimulus is applied. Expected average is less than one minute.||||seconds||95% Confidence Interval|Mean
1344280|NCT01883895|Primary|Change in Pain Intensity Ratings (0-100 Pain Scale)|"Subjects will rate pain intensity using a 0 (no pain) to 100 (most intense pain imaginable) pain rating scale before and after application of a validated pressure stimulator immediately prior to, and after exercise.~Ratings will be recorded at 20 second intervals following each administration of the pressure stimulator for a total of 120 seconds. The ratings will then be averaged over all the time points."|Average pain rating over 120 seconds|Participants completing both exercise sessions and control session|||scores on a scale||95% Confidence Interval|Mean
1344281|NCT01883804|Secondary|The Change in Insulin Use From Baseline to Study Completion.|Exogenous insulin use per kg of body weight.|12 weeks (Baseline and week 12)||||units/Kg body weight||Standard Deviation|Mean
1344282|NCT01883804|Secondary|The Change in Hemoglobin A1c From Baseline to Study Completion.|Investigators aim to observe changes in hemoglobin A1c values, a measure of average blood glucose over the preceding 3 months.|12 weeks (Baseline and week 12)||||percentage||Standard Deviation|Mean
1344283|NCT01883804|Secondary|The Change in C-Peptide AUC Following a MMTT From Baseline to Study Completion.|Investigators aim to observe changes in residual endogenous insulin production as measured by C-peptide 2 hour area under the curve following a Mixed Meal Tolerance Test (MMTT). C-peptide is a measure of endogenous insulin secretion as both are secreted in a 1:1 molar ratio. Individuals ingested a liquid meal (Boost) with a fixed amount of protein, fat and carbohydrate in the fasting state followed by the timed measurements of serum C-peptide at 0, 15, 30, 60, 90 and 120 minutes to compute the AUC.|12 weeks (Baseline and week 12)||||nmol/L/min||Standard Deviation|Mean
1344284|NCT01883804|Primary|The Change From Baseline of DQ8 Antigen Presentation by Peripheral Blood Mononuclear Cells After 6 Weeks of Methyldopa Treatment.|Cryopreserved primary peripheral blood mononuclear cells were used as antigen presenting cells to stimulate engineered T-cells (T-cell receptor transductant) responding to a specific peptide presented by HLA-DQ8. Secreted IL-2 from the engineered T-cell was measured by a highly sensitive ELISA. This was done for both an α-gliadin/DQ8 responding T-cell and a separate insulin/DQ8 responding T-cell.|6 Weeks (Baseline and week 6)||||pg/mL||Standard Error|Least Squares Mean
1344285|NCT01883635|Other Pre-specified|Provision of Social Support|Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.|Baseline to post-intervention (6 weeks later)|This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).|||units on a scale||Standard Deviation|Mean
1344286|NCT01883635|Secondary|Immune Biomarkers|We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.|Baseline to post-intervention (6 weeks later)|The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).|||ng/mL||Standard Deviation|Mean
1344287|NCT01883635|Primary|Psychological Distress|Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.|Baseline to post-intervention (6 weeks later)|The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).|||units on a scale||Standard Deviation|Mean
1344288|NCT01883453|Primary|Reducing Symptoms of a Common Cold|"Using the Wisconsin Upper Respiratory Symptom Score (WURSS-21)it is possible to assess if a nasal spray containing glucose oxidase and glucose would be able to reduce symptoms of a common Cold.~WURSS 21 is a validated tool of calculating the degree of common Cold symptoms. It consists of 21 questions (20 questions are possible to evaluate) which are graded from 0 to 7 (worst degree of symptoms). These 20 questions (sum of all symptoms) are evaluated every day, Min value is thus 0 and max value/person/day is 140. It is thus possible to calculate the mean value of sum of symptoms for each day in the both groups."|One week|Only the participants that fullfilled the study and who had a positive virus sample (Influensa and adenoviruses excluded) were included in the results. These are the participants that are supposed to benefit from a nasal spray with GO.|||units on a scale||Full Range|Mean
1344289|NCT01883440|Primary|Sum of All Symptoms of All Persons That Fullfilled the Study|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|7 days|All of the persons that fullfilled the study|||units on a scale||Full Range|Mean
1344347|NCT01882647|Other Pre-specified|"Percentage of Subjects With IGA Treatment Success at Day 8"|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||percentage of participants|||Number
1344290|NCT01883440|Primary|Sum of All Symptoms in Viruspositive Persons|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|One week|The persons analyzed were those that had a positive viral sampling with Parainfluenza, Corona or Rhinoviruses, that is: the viruses that most often causes common cold and also would be accessible for treatment with a nasal spray.|||units on a scale||Full Range|Mean
1344291|NCT01883427|Primary|Respiratory Infectious Symptoms|Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.|3 months of recording|Only a total of 40 Children fulfilled the study, which means that the Power are to low.|||days||Standard Deviation|Mean
1344292|NCT01882985|Secondary|Toxicity of Combined Docetaxel + Lycopene Therapy|The percentage of subjects experiencing grade 3-4 hematologic and non-hematologic toxicity will be recorded, as well as the reason for ending treatment. This outcome measure was not collected due to lack of funding.|Up to 4 years|Data was not collected for this outcome measure.||||||
1344293|NCT01882985|Secondary|Time to PSA Progression|The definition of time to PSA progression is the date (after the initiation of chemotherapy on day 2) that a 25% or greater increase, and an absolute increase of 2ng/mL or more, from the nadir PSA is documented. If there is no decrease in PSA following chemotherapy, then PSA progression is the date for documentation of a 25% increase from the baseline value along with an increase in absolute value of 2ng/mL or more.|Up to 4 years|Mean time to PSA progression|||days||Standard Deviation|Mean
1344294|NCT01882985|Secondary|Objective Response Rate as Assessed by RECIST Criteria in Either Visceral or Lymph Node Metastases|The percent of subjects achieving an objective response by RECIST criteria in either visceral or lymph node metastases, and the percent achieving clinical complete disappearance of disease at any site, will be recorded.|Up to 4 years|Data was not collected for this objective.||||||
1344295|NCT01882985|Primary|Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates|To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. (>50% reduction from bseline) in subjects treated with a combination of docetaxel and lycopene.|At week 12 of therapy|One patient was inevaluable due to lost to follow up and one patient withdrew consent.|||Participants|||Count of Participants
1344296|NCT01882907|Other Pre-specified|To Compare Changes of Adipocytokine From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5|||||||
1344297|NCT01882907|Other Pre-specified|To Compare Changes of Homeostasis Model Assessment-insulin Resistance and Beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5|||||||
1344298|NCT01882907|Other Pre-specified|To Compare Changes of Insulin and C-peptide From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5|||||||
1344299|NCT01882907|Secondary|To Compare Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups|"Safety assessments~- hypoglycemia, other side effects, Laboratory data, Physical examination, Vital sign with blood pressure and pulse rate, Electrocardiography"|16 weeks, visit 3,4,5|||||||
1344300|NCT01882907|Secondary|To Compare Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5|||||||
1344301|NCT01882907|Secondary|To Compare Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5|||||||
1344302|NCT01882907|Secondary|To Compare Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks , visit 5|||||||
1344303|NCT01882907|Primary|Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group||16 weeks||||% (change of HbA1c)||Standard Deviation|Mean
1344304|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Irinotecan: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan in combination with aflibercept and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter||Standard Deviation|Mean
1344305|NCT01882868|Secondary|Total Body Clearance (CL) for Irinotecan: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter/hour||Standard Deviation|Mean
1344306|NCT01882868|Secondary|Active Metabolite SN-38 / Irinotecan Ratio on Area Under the Concentration Time Curve (Rmet): Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non - compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||ratio||Standard Deviation|Mean
1344307|NCT01882868|Secondary|Terminal Elimination Half-life (t1/2z) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||hours||Standard Deviation|Mean
1344308|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||ng*h/mL||Standard Deviation|Mean
1344309|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||ng*h/mL||Standard Deviation|Mean
1344310|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||ng/mL||Standard Deviation|Mean
1344311|NCT01882868|Secondary|Clearance at Steady State (CLss) for 5-FU: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of 5-FU in combination with aflibercept and irinotecan in Cycle 1.|Pre-dose (prior to aflibercept infusion), 2.5, 21 and 45 hours post 5-FU infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter/hour||Standard Deviation|Mean
1344312|NCT01882868|Secondary|Steady State Drug Concentration (Css) for 5-FU: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of 5-FU in combination with aflibercept and irinotecan in Cycle 1.|Pre-dose (prior to aflibercept infusion), 2.5, 21 and 45 hours post 5-FU infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||ng/mL||Standard Deviation|Mean
1344313|NCT01882868|Secondary|Terminal Elimination Half-life (t1/2z) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||days||Standard Deviation|Mean
1344314|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liters||Standard Deviation|Mean
1344315|NCT01882868|Secondary|Total Body Clearance (CL) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter/day||Standard Deviation|Mean
1344316|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||mcg*day/mL||Standard Deviation|Mean
1344593|NCT01879371|Primary|Cmax|Cmax: maximum measured concentration of Ibuprofen in plasma|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1344317|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to 14 Days Post Start of Infusion (AUC0-14 Day) for Free and VEGF-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||mcg*day/mL||Standard Deviation|Mean
1344318|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Free and VEGF-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||mcg*day/mL||Standard Deviation|Mean
1344319|NCT01882868|Secondary|Time to Reach Maximum Plasma Concentration Observed (Tmax) for Free and VEGF-Bound Aflibercept in Cycle 1: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||days||Full Range|Median
1344320|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Free and Vascular Endothelial Growth Factor (VEGF)-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||mcg/mL||Standard Deviation|Mean
1344321|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||liters||Standard Deviation|Mean
1344322|NCT01882868|Secondary|Total Body Clearance (CL) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||liter/day||Standard Deviation|Mean
1344323|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||mcg*day/mL||Standard Deviation|Mean
1344324|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to 14 Days Post Start of Infusion (AUC0-14 Day) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||mcg*day/mL||Standard Deviation|Mean
1344325|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed pharmacokinetic (PK) analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|Intent-to-Treat (ITT) population included all registered participants.|||mcg/mL||Standard Deviation|Mean
1344335|NCT01882829|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)|The Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) is a 16-item self rated instrument designed to assess the severity of depressive symptoms (30). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).|up to 12 weeks||||change in units on a scale||Standard Deviation|Mean
1344326|NCT01882868|Secondary|Aflibercept Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay|Blood samples of participants were analyzed by using a titer-based, bridging immunoassay developed and validated to detect aflibercept ADA in human serum. Samples with positive antibody levels were further analyzed using a validated, non-quantitative, competitive ligand binding assay to detect NAb.|Baseline, at any time post baseline and 90 days after the last dose of aflibercept|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment. Here 'n' signifies number of participants with available data for specified category.|||participants|||Number
1344327|NCT01882868|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-­treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.|First dose (Day 1 of Cycle 1) of study treatment up to end of treatment visit (30 days after last dose of study treatment) (maximum duration: 77 weeks)|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.|||participants|||Number
1344328|NCT01882868|Secondary|Overall Survival (OS)|OS was defined as the time interval from the date of first study drug administration to the date of death due to any cause. If death was not observed, the participant was censored at the last date the participant was known to be alive or the study cut-off date, whichever was first. OS was estimated by Kaplan-Meier estimates.|Baseline up to death or study cut­-off (maximum duration: 24.7 months)|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.|||months||95% Confidence Interval|Median
1344329|NCT01882868|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval from the date of first study drug administration to the date of first observation of DP or death due to any cause, whichever came first. If death or progression was not observed, the participant was censored at the date of participant’s last valid progression-free tumor assessment prior to the study cut-off date. DP for PFS was assessed by the IRRC based on tumor imaging according to RECIST 1.1. Progression in disease was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study with absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated by Kaplan-Meier estimates.|Baseline and every 6 weeks until DP or death, due to any cause (maximum duration: 16.4 months)|The safety population (all treated [AT] population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.|||months||95% Confidence Interval|Median
1344330|NCT01882868|Primary|Percentage of Participants With Overall Response|Overall response in participants was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) assessed by an independent radiological review committee (IRRC) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions; any lymph node (target or non-target) must have reduction in the short axis to <10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall response and the 95% confidence interval (CI) were provided. The 95% CI was calculated using normal approximation.|Baseline and every 6 weeks until DP (maximum duration: 16.4 months)|EP population: all registered participants with measurable disease at study entry & with at least 1 valid post-baseline tumor evaluation. Participants who died due to DP or had documented radiological progressive disease before first post-baseline imaging evaluation were also included.|||percentage of participants||95% Confidence Interval|Number
1344331|NCT01882829|Secondary|Beck Scale for Suicidal Ideation (BSI)|Mean change in Brief Inventory Symptom from baseline to week 10. The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items are intended to assess a patient’s thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). In this study, scores from the five screening items were included in the overall score. Therefore, total scores could range from 0 to 48, with higher scores reflecting more severe symptoms.|Baseline and Week 10||||change in units on a scale||Standard Deviation|Mean
1344332|NCT01882829|Secondary|HAM-A|Change in Hamilton Anxiety Rating Scale (HAM-A) score from baseline to Week 10. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and >25-30 moderate to severe.|Baseline and Week 10||||change in units on a scale||Standard Deviation|Mean
1344333|NCT01882829|Secondary|Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a brief scale to measure cognitive and executive dysfunction in mood and anxiety disorders, and possesses good reliability and validity. The Massachusetts General Hospital CPFQ was developed to assess each of the 7 most common complaints of depressed patients reporting fatigue or cognitive/executive problems. The CPFQ consists of 7 questions, each rated on a scale from 1 to 6, with 1 indicating greater than normal functioning, 2 indicating normal functioning and with higher numbers indicating poorer functioning. Total score range from 7 (greater than normal function) to 42 (poor function).|At baseline and Visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
1344334|NCT01882829|Secondary|Clinical Global Impression (CGI) Scale|The Clinical Global Impression (CGI) scale assesses overall treatment response in psychiatric patients and has good reliability and validity metrics. The administration time is 2 minutes. This scale consists of three items: Severity of Illness (item 1); Global Improvement (item 2); and Efficacy Index (item 3). Item 1 is rated on a seven-point scale (1 = normal, 7 = among the most extremely ill patients) as is item 2 (1 = very much improved, 7 = very much worse). Full scale is 1 to 14.|up to 12 weeks||||change in units on a scale||Standard Deviation|Mean
1344412|NCT01882257|Other Pre-specified|Short Term Effects on Daily Symptoms and Medical Events|The subjects keep daily logs of certain symptoms and events (pulmonary symptoms that require escalated care, pulmonary infections, doctor visits, hospitalizations, antibiotic use, symptoms of unstable blood pressure). These data are collected throughout the study period|Months 0-16 after enrollment|||||||
1344336|NCT01882829|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).|up to 12 weeks|missing data on one participant|||change in units on a scale||Standard Deviation|Mean
1344337|NCT01882829|Secondary|Patient Rated Inventory of Side Effects (PRISE)|Frequency of observed adverse events over the study treatment period as captured by the PRISE. The Patient Rated Inventory of Side Effects (PRISE) assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other).|up to 12 weeks||||events|||Number
1344338|NCT01882829|Secondary|Sheehan Disability Scale|The Sheehan Disability Scale (SDS) is a self-rated scale which assesses illness-related disability in three areas of functioning: work, social and family. The SDS assess disability or functional impairment across three domains: work/school, social life/leisure activities and family life/home responsibilities. Each domain is scored from 0 (not at all) to 10 (very severely). The three domains can be summarized to evaluate global functional impairment by adding the scores of each of the three domains, resulting in global SDS score ranges from 0 (unimpaired) to 30 (highly impaired).|At baseline and Visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
1344339|NCT01882829|Secondary|Range of Impaired Functioning Tool|"The Range of Impaired Functioning Tool a brief scale for assessing functional impairment related to medical or psychiatric illness and has been demonstrated to possess good psychometric properties. The LIFE-RIFT has a total score and individual domain scores for the following areas of functioning: household duties, work, recreation, relationships with family, relationships with friends, schoolwork, and global life satisfaction (the satisfaction item is patient rated).~Higher scores indicate poorer functioning; scores ≥2 reflect impaired functioning in that domain. Results are reported for the total sum with full range from 3 (no impairment) to 60 (severe impairment), which is based on all individual domain scores."|At baseline and Visit 6 (week 10)|missing data on 2 participants|||change in units on a scale||Standard Deviation|Mean
1344340|NCT01882829|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire Short Form|The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form is a reliable and valid self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by individuals. The raw total score ranges from 14 to 70. Higher scores reflect better oucomes.|At baseline and Visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
1344341|NCT01882829|Primary|Montgomery-Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is s scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Primary outcome is change in MADRS at Visit 6 (Week 10). Higher values represent a worse outcome.|At baseline and visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
1344342|NCT01882725|Secondary|Change in Skin Surface Temperature on the Hind Foot|"Skin surface temperature on the hind foot was recorded in degrees using an infrared thermometer. Change in skin surface temperature in degrees was calculated as the change in measurements before the first procedure administration (baseline) to after the sixth and final procedure administration. It was pre-determined that a minimum mean increase in skin surface temperature of +2.5 degrees across the procedure administration phase would be considered clinically meaningful.~A positive (+) change indicates that the skin surface temperature increased across the procedure administration phase and is positive for study efficacy.~A negative (-) change indicates that the skin surface temperature decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks||||Degrees Farenheit||Standard Deviation|Mean
1344343|NCT01882725|Primary|Change in Skin Perfusion Pressure (SPP)|"Skin Perfusion Pressure (SPP) measured peripheral microcirculation or skin perfusion using a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia, the transient increase in blood flow that occurs following a brief period of ischemia. The SPP value was measured in mmHg.~The per cent (%) change in mean Skin Perfusion Pressure (SPP) in mmHg was calculated as the % change in measurements from before the first procedure administration with the Erchonia® HPS Laser to after the sixth and final procedure administration. It was pre-determined that a minimum mean change in % SPP of +10% or greater across the evaluation period would be considered clinically meaningful.~A positive (+) change indicates that SPP increased across the procedure administration phase and is positive for study efficacy.~A negative (-) change indicates that SPP decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks||||percentage of change||Standard Deviation|Mean
1344344|NCT01882647|Other Pre-specified|Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population at Day 15 and compared to baseline. ITT was defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||Change in %BSA||Standard Deviation|Mean
1344345|NCT01882647|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||units on a scale||Standard Deviation|Mean
1344346|NCT01882647|Other Pre-specified|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8"|"Interim analysis of clinical signs of psoriasis. Treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||percentage of participants|||Number
1344348|NCT01882647|Secondary|"The Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or average degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
1344349|NCT01882647|Primary|"The Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|All subjects were classified into the following datasets: intent-to-treat (ITT), per protocol (PP), and safety populations. Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
1344350|NCT01882543|Other Pre-specified|AQX-1125 Concentrations in Plasma and Urine (Trough Values)|AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6.|Week 4 and Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||ng/mL||Standard Deviation|Mean
1344351|NCT01882543|Secondary|Voiding Frequency as Recorded by Diary Over a 24 Hour Period|For a 24-hour period (within 3 days of the subsequent visit), subjects recorded the frequency of each void prior to visit. The outcome measure was the change from baseline at week 6.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||number of voids||Standard Error|Mean
1344352|NCT01882543|Secondary|Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire|Change from baseline to week 6 in the SF-12v2 questionnaire. Two parameters, PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better Quality of Life.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
1344353|NCT01882543|Secondary|O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]|Change from baseline to week 6 in the O'Leary Sant Symptom and Problem Index combined total scores. Both the ICSI and ICPI consist of 4 questions with responses for the ICSI rated on a scale of 0-5 (maximum score of 20, with a higher score indicating worse symptoms) and for the ICPI on a scale of 0-4 (maximum score of 16, with a higher score indicating worse symptoms). For the combined ICSI/PI the maximum score is 36, with a higher score indicating worse symptoms.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
1344354|NCT01882543|Secondary|Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]|Change in baseline to week 6 in the BPIC-SS participant reported questionnaire total score. The total BPIC-SS score ranges from 0-38, with a higher score indicative of worse symptoms. A score of 19 or more was considered to be discriminating between IC/BPS and overactive bladder at screening.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
1344355|NCT01882543|Secondary|Change From Baseline in the Maximum Bladder Pain Score (Clinic)|Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visits. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
1344356|NCT01882543|Secondary|Change From Baseline in the Average Bladder Pain Score (Clinic)|Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visit. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
1344357|NCT01882543|Secondary|Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)|Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
1344358|NCT01882543|Primary|Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)|Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
1344387|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3|Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Joints||Standard Error|Least Squares Mean
1344413|NCT01882257|Primary|The Frequency of Technical Errors Related to the Home-based Overnight Testing.|All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).|Overnight testing (4-13 hours)||||participants|||Number
1344359|NCT01882465|Primary|Corneal Staining|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.|20 minutes and 7 hours post lens fitting|All subjects that completed every study visit without a major protocol deviation.|||units on a scale|Subject Eyes|Standard Deviation|Mean
1344360|NCT01882439|Secondary|Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6|BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participants answered 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averaged the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score >0 cm, and were evaluable.|||cm||Standard Error|Least Squares Mean
1344361|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344362|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344363|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344364|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
1344365|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344431|NCT01881737|Secondary|Social Responsiveness Scale (SRS) Total Score|SRS total score (total range 0-195); higher scores mean more abnormal social behaviors.|12 weeks||||SRS total score (total range 0-195)||Standard Deviation|Mean
1347024|NCT01841593|Primary|Raltegravir AUC(0-12h )|AUC0-12h: Area under the concentration time curve over 12 hours in the absence, and presence, of amlodipine.|Post dose after day 7 of daily dosing||||ng*h/mL||95% Confidence Interval|Geometric Mean
1344366|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344367|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344368|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344369|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344370|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher mental health domain score represents better mental health functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344371|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-emotional domain score represents better role-emotional functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344372|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher social functioning domain score represents better social functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344493|NCT01880593|Secondary|BSS Score|BECK Scale for Suicidal Ideation (BSS) - 0-13 Minimal; 14-19 Mild; 20-28 Moderate; 29-63 Severe|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
1344373|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher vitality domain score represents better vitality. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344374|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent’s view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher general health domain score represents better general health perceptions. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344375|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher bodily pain domain score represents less bodily pain. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344376|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Items in the role-physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-physical domain score represents better role-physical functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344377|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represent levels & kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher physical functioning domain score represents better physical functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344378|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better mental health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344388|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3|The blinded investigator or qualified assessor assessed how the participant’s overall arthritis appeared at the time of the visit. This was an evaluation based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||mm||Standard Error|Least Squares Mean
1346685|NCT01845792|Primary|Progression-Free Survival|Progression-free survival at 3 months.|3 months|Due to early closure of the study and the low number of patients enrolled, no statistics or firm conclusions can be made.|||Participants|||Count of Participants
1344379|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||T-scores||Standard Error|Least Squares Mean
1344380|NCT01882439|Secondary|Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6|Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for a total score of 0-6. Higher score indicates greater severity of enthesitis. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline LEI >0, and were evaluable.|||Units of scale||Standard Error|Least Squares Mean
1344381|NCT01882439|Secondary|Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6|The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score >0, and were evaluable.|||Units of scale||Standard Error|Least Squares Mean
1344382|NCT01882439|Secondary|Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6|Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline DSS >0, and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344383|NCT01882439|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6|PASI determines psoriasis severity based on lesion severity and percentage of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, and scaling evaluated separately for the head and neck, upper limbs, trunk, and lower limbs and then rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis and is assigned a numerical score: 0=no involvement; 1=0% to 9%; 2=10% to 29%; 3=30% to 49%; 4=50% to 69%; 5=70% to 89%; 6=90% to 100%. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the 4 body areas is the PASI. PASI75 is defined as a 75% reduction from baseline in PASI. n=number of responders.|Months 1, 3, and 6|All participants who were randomized and received at least 1 dose of study drug with PASI >0 and BSA ≥3% at baseline.|||Percentage of participants|||Number
1344384|NCT01882439|Secondary|Change From Baseline in Physician’s Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6|The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine the PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO >0, and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344385|NCT01882439|Secondary|Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6|The PsARC covers 4 measures: Tender joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. n=number of responders.|Week 2, Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
1344386|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3|Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Joints||Standard Error|Least Squares Mean
1344410|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism|When home-based sleep testing is performed, and at 3, 6, and 12 months afterward, subjects will have blood tests to determine if treatment of sleep-disordered breathing has any effects on glucose intolerance/diabetes and/or blood cholesterol/lipid levels|Months 4-16|||||||
1344389|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participant’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable|||mm||Standard Error|Least Squares Mean
1344390|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3|Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||mm||Standard Error|Least Squares Mean
1344391|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable|||mg/L||Standard Error|Least Squares Mean
1344392|NCT01882439|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6|The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. n=number of participants evaluable at each visit.|Week 2 and Months 1, 2, 4, and 6|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Units on scale||Standard Error|Least Squares Mean
1344393|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6|ACR20 was calculated as a ≥20% improvement from baseline in tender /painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
1344394|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6|ACR70 was calculated as a ≥70% improvement from baseline in tender /painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
1344395|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6|ACR50 was calculated as a ≥50% improvement from baseline in tender /painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
1344396|NCT01882439|Primary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3|The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344397|NCT01882439|Primary|Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-reactive protein (CRP).|Month 3|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
1344398|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344399|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344400|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Punctal Plugs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344401|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344402|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344403|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344404|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer’s score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344405|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344406|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
1344407|NCT01882413|Secondary|Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9|"Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of Yes to the Investigator Dry Eye History question."|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated data MMP-9 and data available for analysis.|||percentage of participants|||Number
1344408|NCT01882413|Primary|Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.|Up to 60 Days Prior to Surgery|Per-protocol population included all enrolled participants who completed all the study assessments without major protocol violations.|||percentage of participants|||Number
1344409|NCT01882257|Other Pre-specified|Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing|Clinical features (neck and waist circumference, body mass index, level and duration of spinal cord injury, lung function tests, questionnaire results) will be analyzed to determine if certain attributes predict the presence or severity of sleep-disordered breathing.|Month 4 after enrollment|||||||
1344414|NCT01882257|Primary|Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults|After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.|Month 4 after enrollment||||participants|||Number
1344415|NCT01882062|Secondary|Correlation Between Primary Outcome Measure and Clinical Parameters|Correlating an improvement of brain energy profile with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).|visit 1 (baseline), visit 2 (after 1 month of treatment)||2015-12-31|12/2015||||
1344416|NCT01882062|Primary|Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr|"The Pi/PCr Ratio is a measure of brain metabolism and it is an index of mitochondrial oxidative regulation.~A 6-cm 31P transmit/receive surface coil (RAPID Biomedical GmbH, Rimpar, Germany) was used to collect free induction decays for 4 minutes at rest, 8 minutes during visual activation with 6-Hz red/black checkerboard flashes, and 8 minutes after stimulation. Subjects were able to focus on the flashes with a nonmagnetic mirror mounted above their eyes while all lights in the room were turned off. The Pi/PCr ratio was then calculated to determine brain response to cortical activation."|visit 1 (baseline), visit 2 (after 1 month of treatment)||||ratio||Standard Deviation|Mean
1344417|NCT01881984|Secondary|Pharmacokinetic (pK)Analysis|Results from the pharmacokinetic (pK)analysis (the rate of conversion of the phenylbutyrate to phenylacetate) will also be reviewed to assess for changes pre- and post-dosing with Ravicti as well as changes in these levels at the different doses of Ravicti.|7 weeks|Due to the small sample size in this Phase I study, details on the analysis cannot be provided due to concerns with subject confidentiality.||||||
1344418|NCT01881984|Primary|Metabolic Stress|Changes in the assessments of metabolic stress pre- and post-dosing with Ravicti will be the main outcome variable.|7 weeks|Due to the small sample size in this Phase I study, details on the analysis cannot be provided due to concerns with subject confidentiality.||||||
1344419|NCT01881932|Primary|Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy.|The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.|Week 12|Zero participants analyzed due to early termination of study.||||||
1344420|NCT01881776|Other Pre-specified|Total Hours of Sleep|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.|first postoperative week (on day 7)||||hours||Standard Deviation|Mean
1344421|NCT01881776|Other Pre-specified|Time to Discharge Home|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.|throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)||||minutes||Standard Deviation|Mean
1344422|NCT01881776|Other Pre-specified|Length of PACU Stay|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.|throughout the first postoperative week (how long patients stayed in PACU just after the operation)||||minutes||Standard Deviation|Mean
1344423|NCT01881776|Other Pre-specified|Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate|throughout the first postoperative week (how many patients left PACU immediately just after the operation)||||participants|||Number
1344424|NCT01881776|Secondary|The Number of Patients Consume ≥1 Dose of Analgesics|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).|throughout the first postoperative week||||participants|||Number
1344425|NCT01881776|Secondary|Time-to-first Pain|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).|throughout the first postoperative week||||hours||Standard Deviation|Mean
1344426|NCT01881776|Primary|Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4|The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)|throughout the first postoperative week on days 1, 2, 3, and 7||||participants|||Number
1344427|NCT01881737|Secondary|Pregnenolone Level in Peripheral Blood as Measured at Baseline and After 12 Weeks||12 weeks|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for one of the participants who dropped out were included in the analyses.|||ng/ml||Standard Deviation|Mean
1344428|NCT01881737|Secondary|Repetitive Behavior Scale||12 weeks|Data were not collected for this Outcome Measure because the total score is not a very valid measure of receptive behaviors.||||||
1344429|NCT01881737|Secondary|Vineland Adaptive Behavior Scale|Adaptive Behavior Composite Score (score range 20-160); higher scores mean more typical adaptive behaviors.|12 weeks||||score (range 20-160)||Standard Deviation|Mean
1344430|NCT01881737|Secondary|Sensory Profile Questionnaire Total Score|scores on a scale (range: 38-190); lower scores mean more abnormal sensory problems.|12|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for one of the participants who dropped out were included in the analyses.|||scores on a scale (range: 38-190)||Standard Deviation|Mean
1344432|NCT01881737|Primary|Number of Participants With Adverse Events According to Dosage Record and Treatment Emergent Symptom (DOTES) as Assessed at All Follow-up Visits (2, 4, 6, 8, 10, 12, and 16 Weeks)||2, 4, 6, 8, 10, 12, and 16 weeks|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for the two participants who dropped out were included in the analyses.|||participants|||Number
1344433|NCT01881230|Secondary|Percentage of Participants Who Discontinued From All Study Treatment Due to TEAEs|Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen with an onset date on or after the date of the first dose of IP through 28 days after the last dose.|From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C|The Safety/Treated population includes all randomized participants who received at least 1 dose of IP.|||percentage of participants||95% Confidence Interval|Number
1344434|NCT01881230|Secondary|Percentage of Participants Experiencing Dose Modifications (Reductions and Interruptions)|The number of participants with dose modifications occurring during the treatment period. Dose reductions and interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C|The Safety/Treated population includes all randomized participants who received at least 1 dose of IP.|||percentage of participants|||Number
1344435|NCT01881230|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Treatment-emergent adverse events (TEAEs) were defined as any AEs that began or worsened with the onset date on or after the date of the first dose of IP through 28 days after the last dose. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on the participant's symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity as follows: Grade 1 = Mild – transient or mild discomfort; no medical intervention required; Grade 2 = Moderate – mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death.|From randomization through to 28 days after the last dose of IP; up to data cut off date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C|The safety population includes all randomized participants who received at least 1 dose of IP.|||participants|||Number
1344436|NCT01881230|Secondary|Kaplan-Meier Estimates of Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death (from any cause).|From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C|The ITT population includes all randomized participants regardless of whether the participant received any Investigational Product (IP) or had any efficacy assessments collected.|||months||95% Confidence Interval|Median
1344437|NCT01881230|Secondary|Percentage of Participants Who Initiated Cycle 6 Receiving Doublet Combination Therapy|The percentage of participants who initiated Cycle 6 receiving doublet combination therapy regardless of the need for dose modifications.|Cycle 6|ITT includes all randomized participants regardless of whether they received any IP or had any efficacy assessments collected. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment prior to the data cutoff date.|||percentage of participants||95% Confidence Interval|Number
1344438|NCT01881230|Secondary|Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.|Percentage of participants with an Objective Complete or Partial Overall Response according to RECIST 1.1 and defined as: Complete response-disappearance of all target lesions; partial response at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.|Disease response was assessed every 6 weeks; from date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C|ITT includes all randomized participants regardless of whether they received any IP or had any efficacy assessments collected. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment prior to the data cutoff date.|||percentage of participants||95% Confidence Interval|Number
1344439|NCT01881230|Primary|Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.|PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir.|From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C|ITT includes all randomized participants regardless of whether they received any IP or had any efficacy assessments collected. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment prior to the data cutoff date.|||months||95% Confidence Interval|Median
1344440|NCT01881126|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1344441|NCT01881113|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1344442|NCT01881113|Secondary|Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||% of participants|||Number
1344443|NCT01881113|Secondary|Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||% of participants|||Number
1344444|NCT01881113|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344445|NCT01881113|Secondary|Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344446|NCT01881113|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344447|NCT01881113|Secondary|Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344448|NCT01881113|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344449|NCT01881113|Secondary|Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344450|NCT01881113|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344451|NCT01881113|Secondary|Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344452|NCT01881113|Secondary|Tearing at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344453|NCT01881113|Secondary|Tearing at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344454|NCT01881113|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1347025|NCT01841593|Primary|Amlodipine C24h|measured concentration 24 hours after dose in the absence, and presence, of raltegravir|12 hours post-dose on day 7 of daily dosing.||||ng/mL||95% Confidence Interval|Geometric Mean
1344455|NCT01881113|Secondary|Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344456|NCT01881113|Secondary|Chemosis at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344457|NCT01881113|Secondary|Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344458|NCT01881113|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344459|NCT01881113|Secondary|Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344460|NCT01881113|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344461|NCT01881113|Secondary|Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1344462|NCT01881113|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1344463|NCT01881113|Primary|Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1344464|NCT01881113|Primary|Ocular Itching at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1344465|NCT01881113|Primary|Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1344466|NCT01881087|Secondary|Failed Spinal Block Rate|Failed Spinal Block Rate for each treatment group|15 minutes after dose||||Participants|||Count of Participants
1344467|NCT01881087|Primary|Probability of Motor Block|Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%|200 minutes||||percentage of motor block|||Number
1344468|NCT01880840|Primary|Safety|"The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to <6 years of age with allergic rhinitis.~Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments.~Data for each age strata will be summarized separately as well as combined."|one month of treatment||||adverse events|||Number
1344469|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|From week 16 to end of trial (week 27)|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
1344494|NCT01880593|Secondary|HAM-A Score|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe.|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
1344470|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
1344471|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|From Week 16 to end of trial (week 27)|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product. Subjects were grouped either according to dosing pattern or treatment algorithm received. 451 subjects contributed to the analysis. Subjects in the safety analysis set contributed to the evaluation “as treated”.|||episodes|||Number
1344472|NCT01880736|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition|Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
1344473|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))|The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
1344474|NCT01880736|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||events|||Number
1344475|NCT01880736|Secondary|Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial|The number of subjects who achieved the pre-defined HbA1c target (<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|After 26 weeks of treatment|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||Subjects|||Number
1344476|NCT01880736|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Week 0, week 26|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||mg/dL||Standard Deviation|Mean
1344477|NCT01880736|Primary|Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)|Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1344478|NCT01880723|Secondary|Peripheral Oxygen Saturation|A finger pulse oximeter allowed for the measurement of peripheral oxygen saturation at baseline, 30-, 60- and 90-minutes post albuterol in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol||||percent of oxygenated hemoglobin||Standard Deviation|Mean
1344479|NCT01880723|Primary|Net Exhaled Chloride|"The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point:~Net Cl- efflux – [Cl- X-min post] + (([Na+ X-min post]-[Na+Baseline])/ [Na+Baseline]) x [Cl- X-min post])"|baseline to 90 minutes post albuterol administration||||mmol/L||Standard Deviation|Mean
1344480|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Nitric Oxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration||||mL/min/mmHg||Standard Deviation|Mean
1344481|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Carbon Monoxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration||||mL/min/mmHg||Standard Deviation|Mean
1344482|NCT01880723|Primary|Exhaled Sodium (mmol/L)|We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration.|up to 90-minutes post albuterol||||mmol/L||Standard Deviation|Mean
1344483|NCT01880697|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVc is reported.|Day 1 through Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.|||Subjects|||Number
1344484|NCT01880697|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIVc|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIVc are reported.|Day 1 to Day 4 post-vaccination|Analysis was done on the solicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.|||Subjects|||Number
1344485|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"The antibody responses following one dose of TIVc were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/day 1|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1344486|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVc.~Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer >10 to at least a 4-fold increase in post-vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40 % for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.|||Percentages of Subjects||95% Confidence Interval|Number
1344487|NCT01880697|Primary|Percentage of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.|||Percentages of Subjects||95% Confidence Interval|Number
1344488|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVc|The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVc The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years.|Day 22/day 1|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1344489|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVc.~Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.|||Percentages of Subjects||95% Confidence Interval|Number
1344490|NCT01880697|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study.|||Percentages of Subjects||95% Confidence Interval|Number
1344491|NCT01880593|Secondary|Patient Rated Inventory of Side Effects (PRISE)|Number of Participants with PRISE|2 weeks after last ketamine infusion||||Participants|||Count of Participants
1344492|NCT01880593|Secondary|CSSRS Score|Columbia Suicide Severity Rating Scale (CSSRS) - Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
1344495|NCT01880593|Secondary|CGI-S Score|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
1344496|NCT01880593|Secondary|QIDS-SR Score|Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) score - Each item is rated 0 (no depression) to 3 (severe depression), for a total score range of 0 (no depression) to 27 (severe depression).|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
1344497|NCT01880593|Primary|MADRS-S Score|The Montgomery Asberg Depression Rating Scale (MADRS-S) has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
1344498|NCT01880515|Secondary|Progression Free Survival|From the start of consumption of BIBW 2992 to the date progression or last follow up|Participants will be followed for the duration of the treatment, an average of 8 weeks.|We estimated the progression free survival with the Kaplan Meier method, and comparisons among groups were performed with the log-rank test.|||months||95% Confidence Interval|Median
1344499|NCT01880515|Secondary|Progression Free-survival|The measure will be from the start of consumption to the first documented evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or if patients still survive the measure will be made after 24 weeks|24 weeks from baseline||2017-09-30|09/2017||||
1344500|NCT01880515|Secondary|Quality of Life (QL)|A QL questionnaire from European Organization for Research and Treatment of Cancer (EORTC) organization (spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression|from baseline to 6 months|||||||
1344501|NCT01880515|Primary|Frequency of Participants Who Experienced Any Grade of Rash As Characterized By The Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0|Sum of participants who experienced any grade rash according to the Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0, from the initiation of BIBW2992 compared to week 8.|Percentage of adverse events at week 8|Forty five patients were assigned to receive reactive treatment; the other 45 received pre-emptive tetracycline.There were no differences among demographics, disease stage and dermatological baseline characteristics between treatment groups.|||Percentage of Patients w/any grade rash|||Number
1344502|NCT01880437|Secondary|Area Under the Concentration-time Curve (AUC) of Cytarabine|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose, 0.25, 0.5, 1, 3, 6 hours post-dose on Days 1, 8 and 29|No participants were enrolled as the study was terminated prior to the initiation of Cohort 2.||||||
1344503|NCT01880437|Secondary|Pharmacokinetics (PK): Steady-state Plasma Concentration of Vismodegib|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose on Days 8, 29 and 57|As the study was terminated prior to Cohort 2 enrollment, PK analysis could not be performed, as planned.||||||
1344504|NCT01880437|Secondary|Percentage of Participants With an Event of Death During the Study||Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.|||percentage of participants|||Number
1344505|NCT01880437|Secondary|Median Overall Survival (OS) Time|OS was defined as the time from start of study drug to death from any cause. OS was estimated using Kaplan-Meier analysis. Participants alive at the last date known to be alive were censored for the analysis.|Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.|||months||95% Confidence Interval|Median
1344506|NCT01880437|Secondary|Duration of Overall Response (DOR)|DOR is defined as the time from the first occurrence of a documented overall response to the time of relapse, as determined by the investigator using International Working Group (IWG) criteria (Participants not falling under any of the response criteria [CR or CRi or MLFS or PR] described under outcome measure 1 were considered as non-responders) or death from any cause during the study (defined as death within 30 days after the last dose of study drug).|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy population including participants who were considered as responders.|||weeks||95% Confidence Interval|Median
1344507|NCT01880437|Secondary|Percentage of Participants With CR, CRi, MLFS or PR at Anytime During Study Treatment|CR was defined as achieved if the neutrophils count >1000 cells/µL, platelets count >100000/µL, bone marrow blasts <5%, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of EMD. CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils > 1000 cells/µL or NA or platelets count >100000/µL or NA, bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods. The 95% confidence intervals (CI) were constructed using Blyth-Still-Cassella method.|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population included all enrolled participants. Here “number of participants analyzed” included participants who were evaluable for tumor response at anytime during the study.|||percentage of participants||95% Confidence Interval|Number
1344516|NCT01880424|Primary|12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder|"A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was “Considerably relieved” or “Completely relieved”) for at least 6 out of the 12 weeks of the Treatment Period.~Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an IBS degree of relief score for a particular Treatment Period week, the patient was not considered a responder for that week.|||Participants|||Number
1344508|NCT01880437|Primary|Percentage of Participants With a Complete Response (CR) or CR With Incomplete Blood Count Recovery (CRi) or Morphologic Leukemia Free State (MLFS) or Partial Response (PR) at Week 8|CR was defined as achieved if the neutrophils count was greater than (>) 1000 cells per microliter (µL), platelets count >100000/µL, bone marrow blasts percentage (%) less than (<) 5, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of extra medullary disease (EMD). CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils >1000 cells/µL or Not applicable [NA] or platelets count >100000/µL or NA), bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods.|Week 8|As the primary efficacy time-point (Week 8) was not reached for all participants due to study termination based on interim data analysis, the analysis of this outcome measure could not be performed, as per planned analysis.||||||
1344509|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Discomfort|"The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period).~Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
1344510|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Pain|"The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period).~Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
1344511|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Bloating|"The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period).~Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
1344512|NCT01880424|Secondary|Change From Baseline in 12-week Severity of Straining|"The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period).~Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount)."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
1344513|NCT01880424|Secondary|Change From Baseline in 12-week Stool Consistency|"The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale [BSFS] score from the SBMs occurring during the 12-week Treatment Period).~Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts [difficult to pass] to 7=Watery, no solid pieces [entirely liquid])."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale (BSFS)||Standard Error|Least Squares Mean
1344514|NCT01880424|Secondary|Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period).~SBM is defined as a bowel movement without laxative use in the preceding 24 hours."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||SBMs per Week||Standard Error|Least Squares Mean
1344515|NCT01880424|Secondary|Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period).~A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||CSBMs per Week||Standard Error|Least Squares Mean
1344545|NCT01879722|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng*hr/mL||Standard Deviation|Mean
1346746|NCT01844765|Secondary|Rate of Cytogenetic Response Category|Rate of cytogenetic response (complete, partial, major, minor, minimal and no response) in Ph+ CML-CP resistant/intolerant to imatinib or dasatinib by 6, 12, 18,24, 36, 48 and 66 cycles|6, 12, 18, 24, 36, 48, 66 cycles||2021-10-31|10/2021||||
1344517|NCT01880424|Primary|12-week Abdominal Pain/Abdominal Discomfort Weekly Responder|"A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period.~Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain.~Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an abdominal pain score or abdominal discomfort score for a particular Treatment Period week, the patient was not considered a responder for that week.|||Participants|||Number
1344518|NCT01880320|Primary|Changes From Baseline in Non-Inflammatory Lesion Counts||Baseline - Week 12|ITT Population, Multiple Imputation|||lesions||Standard Error|Least Squares Mean
1344519|NCT01880320|Primary|Changes From Baseline in Inflammatory Lesion Counts||Baseline - Week12|ITT Population, Multiple imputation|||Lesions||Standard Error|Least Squares Mean
1344520|NCT01880320|Primary|Success Rate|"Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).~Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets."|Week 12|Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.|||percentage of participants|||Number
1344521|NCT01880099|Primary|Smoking Choice Procedure|After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.|Data was acquired during a single test session during week 3 of drug intervention.|The number of participants analyzed per arm for this outcome is different than participant flow data because not every participant completed the smoking choice session.|||# of choices to smoke (out of 10)||Standard Deviation|Mean
1344522|NCT01880086|Secondary|Men's Sexual Health Questionnaire (MSHQ) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 20. Minimum score is considered most symptomatic, maximum score is considered least symptomatic.|3 months post initial visit||||scores on a scale||Standard Deviation|Mean
1344523|NCT01880086|Secondary|Sexual Health Inventory for Men (SHIM) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 25. The minimum value is most symptomatic and maximum value is least symptomatic.|3 months post initial visit||||scores on a scale||Standard Deviation|Mean
1344524|NCT01880086|Secondary|Estradiol||3 months post initial visit||||pg/mL||Standard Deviation|Mean
1344525|NCT01880086|Secondary|Hematocrit (%)|Measure hematocrit from baseline.|3 months post initial visit||||percentage||Standard Deviation|Mean
1344526|NCT01880086|Secondary|Androgen Deficiency in the Aging Male (ADAM) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 0 and maximum score is 10. 0 is most symptomatic, and 10 is least symptomatic.|3 months post initial visit||||scores on a scale||Standard Deviation|Mean
1344527|NCT01880086|Secondary|Other Hormonal Profile (Change From Baseline)|Luteinizing hormone (LH)|3 months post initial visit||||IU/mL||Standard Deviation|Mean
1344528|NCT01880086|Primary|Serum Total Testosterone (Change From Baseline)|Morning venipuncture of serum total testosterone.|3 months post initial visit||||ng/mL||Standard Deviation|Mean
1344529|NCT01879852|Secondary|Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.|||log (ng/mmol)||Standard Deviation|Mean
1344530|NCT01879852|Secondary|Single Leg Forward Hop Index|Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100]|7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. 2 subjects in the Standard Rehabilitation group and 1 subject in the Standard + Quadriceps Intensive Strengthening group did not complete hop testing.|||percentage||Standard Deviation|Mean
1344531|NCT01879852|Primary|Change in Tibial Articular Cartilage Volume|A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.|Baseline (pre-surgery) to 1 year post-surgery|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. Images were not analyzable for one subject in the Standard+Quadriceps Intensive Strengthening group.|||percentage change from baseline||Standard Deviation|Mean
1344532|NCT01879852|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score|The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.|||units on a scale||Standard Deviation|Mean
1345006|NCT01871805|Secondary|AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)|Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
1344533|NCT01879800|Secondary|Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up|"The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.~Each item is scored independently based on a five-point, ratio scale. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. Lastly, a score above 30 represents severe anxiety severity. The mean change in ratings will be assessed from baseline to 3 and 6 months follow up."|3- and 6- Month Follow-Up||||units on a scale||Standard Error|Mean
1344534|NCT01879800|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale and at 3 and 6 month follow-ups.~Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|3-month and 6-Month Follow-Up||||units on a scale||Standard Deviation|Mean
1344535|NCT01879800|Primary|Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up.|"The World Health Organization Quality of Life Measure- Physical scale assesses quality of life in physical health- specifically in activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, and Work Capacity. Outcome measure will be the change from baseline, at 3, and 6 months.~Each item ranges in score from 1-5. Individual items are rated on a 5 point Likert scale where 1 indicates low, negative perceptions and 5 indicates high, positive perceptions. As such, domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life.~The mean score of the items within this physical domain is used to calculate the overall physical domain score. Mean scores are then multiplied by 4, yielding a score of 4 to 20. A higher domain score indicates a higher quality of life in physical ability."|Change at 3 and 6- Month Follow-up||||units on a scale||Standard Error|Mean
1344536|NCT01879735|Primary|Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar||All measurements are performed in one day.||||percentage of participants|||Number
1344537|NCT01879722|Secondary|CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I|CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||mL/hour||Standard Deviation|Mean
1344538|NCT01879722|Secondary|Fe: Fraction of Drug Excreted in Urine for TAK-063|Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||percent||Standard Deviation|Mean
1344539|NCT01879722|Secondary|Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|Ae(0-24) is a measure of the total amount of study drug excreted in the urine from time 0 to 24 hours postdose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng||Standard Deviation|Mean
1344540|NCT01879722|Secondary|Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24)|Accumulation ratios between Day 7 AUC(0-24) and Day 1 AUC(0-24), (Day 7/Day 1). Estimated Ratio (Day 7/Day 1) is the exponentiated results of the difference between Day 7 and Day 1 in log-transformed values which resolves to the ratio of Day 7/Day 1 estimates.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ratio||90% Confidence Interval|Mean
1344541|NCT01879722|Secondary|AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24)|AUC(0-24) Ratio is the ratio of AUC(0-24) values of the metabolite compared to the parent calculated by dividing AUC(0-24) values of metabolite M-I with those of the parent drug TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ratio||Standard Deviation|Mean
1344542|NCT01879722|Secondary|Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Molar Ratio is the ratio of Cmax molar values of the metabolite compared to the parent calculated by dividing Cmax molar values of metabolite M-I with those of TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ratio||Standard Deviation|Mean
1344543|NCT01879722|Secondary|Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I|Cav is the Average plasma concentration on Day 1, calculated as AUC(0-24)/24 on Day 1. Cavss is the average plasma concentration on Day 7, calculated as AUC(0-24)/24 on Day 7.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants for whom PK data was available for analysis.|||ng/mL||Standard Deviation|Mean
1344544|NCT01879722|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||liter/hour||Standard Deviation|Mean
1345089|NCT01871090|Secondary|Time to Clinical/Treatment Decision|Defined as the time from the Emergency Department Check In Time until the first of: Time of Clinical/Treatment Decision or Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission||||Minutes||Full Range|Median
1344546|NCT01879722|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the Last Quantifiable Concentration.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng*hr/mL||Standard Deviation|Mean
1344547|NCT01879722|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||hour||Full Range|Median
1344548|NCT01879722|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng/mL||Standard Deviation|Mean
1344549|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1344550|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1344551|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1344552|NCT01879722|Primary|Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1344553|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28|The appearance of the Hunner’s lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 28|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.|||percentage of participants|||Number
1344554|NCT01879683|Secondary|Change From Baseline in Patient Reported IC Symptom: Daily Total Voids|The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement|Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.|||voids||Standard Deviation|Mean
1344555|NCT01879683|Secondary|Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain|Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.|Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.|||score on a scale||Standard Deviation|Mean
1344556|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14|The appearance of the Hunner’s lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 14|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.|||percentage of participants|||Number
1347026|NCT01841593|Primary|Raltegravir C12h|measured concentration 12 hours after dose in the absence, and presence, of amlodipine.|12 hours post-dose on day 7 of daily dosing.||||ng/mL||95% Confidence Interval|Geometric Mean
1344557|NCT01879618|Secondary|Mean Percent of HD Sessions With an Acceptable Dose|A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.|20 HD sessions (up to 4 hours)|FAS was used for all efficacy analyses which included all participants who received at least one dose of study medication. For this endpoint, there were 2630 evaluable HD sessions from 148 participants.|||Percentage of HD sessions||95% Confidence Interval|Mean
1344558|NCT01879618|Primary|Mean Percent of Successful HD Sessions|A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant’s blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.|20 HD sessions (up to 4 hours)|The Full Analysis Set (FAS) was used for all efficacy analyses which included all participants who received at least one dose of study medication. There were 2776 HD sessions from 151 participants included in the primary analysis.|||Percentage of HD Sessions||95% Confidence Interval|Mean
1344559|NCT01879579|Other Pre-specified|Qualitative Patient Satisfaction Interview|The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.|After patient reaches optimal insulin dose or at 12 weeks|||||||
1344560|NCT01879579|Other Pre-specified|Costs - Co-pays|At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.|baseline||||participants|||Number
1344561|NCT01879579|Other Pre-specified|Costs - Patient Travel Time|The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.|12 weeks||||minutes||Inter-Quartile Range|Median
1344562|NCT01879579|Other Pre-specified|Costs - Titration Visit Information|The number of insulin titration visits (whether by phone or in the clinic).|12 weeks|Participants who completed the allocated intervention (and the participant who discontinued insulin early).|||insulin titration visits||Inter-Quartile Range|Median
1344563|NCT01879579|Other Pre-specified|Costs - Provider Time Spent on Insulin Titration Visits|Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.|12 weeks|Insulin titration visits with a duration recorded.|||minutes|Participants|Inter-Quartile Range|Median
1344564|NCT01879579|Other Pre-specified|Patient Healthcare Utilization|The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).|12 weeks|All participants.|||hospital visits|||Number
1344565|NCT01879579|Other Pre-specified|Percentage of Successful Phone Calls|The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.|||percentage of phone calls|Participants||Number
1344566|NCT01879579|Other Pre-specified|Percentage of Text Message Responses|The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.|||percentage of text messages|Participants||Number
1344567|NCT01879579|Secondary|Incidence of Hypoglycemia|The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.|12 weeks|This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild.|||instances of hypoglycemia|||Number
1344568|NCT01879579|Secondary|Change in Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.|||score on satisfaction scale||Standard Deviation|Mean
1344569|NCT01879579|Secondary|Treatment Satisfaction After Initiation of Insulin Titration|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.|||score on satisfaction scale||Standard Deviation|Mean
1344570|NCT01879579|Secondary|Baseline Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient’s satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|baseline|All participants who completed the treatment satisfaction questionnaire at baseline.|||score on satisfaction scale||Standard Deviation|Mean
1344571|NCT01879579|Secondary|Hemoglobin A1c|Change in hemoglobin A1c|baseline, 12 weeks (approximately 3 months)|All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks.|||mg/dL||Standard Deviation|Mean
1344572|NCT01879579|Secondary|Time to Reach Optimal Long-acting Insulin Dose|The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.|12 weeks|Participants who reached optimal long-acting insulin dose.|||weeks||Inter-Quartile Range|Median
1344573|NCT01879579|Primary|Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose||12 weeks|No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy.|||percentage of participants|||Number
1344574|NCT01879553|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one dose of TIV is reported.|Day 1 through Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data|||Number of subjects|||Number
1344575|NCT01879553|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination||||Number of subjects|||Number
1344576|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV|"The antibody responses following one dose of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
1344577|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1344578|NCT01879553|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1344579|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
1344580|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (baseline)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
1344581|NCT01879553|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIV .~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study|||Percentage of subjects||95% Confidence Interval|Number
1344582|NCT01879540|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age subjects reporting any unsolicited adverse event (AEs) between Day 1 to 4 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 22 after receiving one dose of aTIV are reported.|Day 1 to Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who had post-vaccination unsolicited AE records|||Participants|||Number
1344583|NCT01879540|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of aTIV are reported.|Day 1 to Day 4 post vaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records|||Participants|||Number
1344592|NCT01879371|Secondary|AUC(0-inf)|AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1344584|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of GMRs of post vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
1344585|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in HI antibody titers after receiving one dose of aTIV.~Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer ≥10 to at least a 4-fold increase in post-vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >30% of subjects achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22|Analysis was done on the per-protocol population|||Percentage of subjects||95% Confidence Interval|Number
1344586|NCT01879540|Primary|Percentages of Subjects With Haemagglutinin Inhibition(HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV.|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the of subjects achieving HI titers ≥ 40 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population|||Percentage of subjects||95% Confidence Interval|Number
1344587|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of geometric mean ratio GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
1344588|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in SRH area against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if>30% of subjects achieve seroconversion or significant increase in post-vaccination SRH area."|Day 22|Analysis was done on the per-protocol population|||Percentage of subjects||95% Confidence Interval|Number
1344589|NCT01879540|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.|||Percentage of subjects||95% Confidence Interval|Number
1344590|NCT01879410|Secondary|Change From Baseline(BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the 2 assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, day by baseline and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1344591|NCT01879410|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model with covariates of baseline FEV1 (mean of the two assessments made 30 mins and 5 mins pre-dose on Day 1), smoking status, and treatment. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all randomized participants who received at least 1 dose of randomized study drug in the Treatment Period. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information and with >= post BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1347058|NCT01840605|Secondary|Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)|Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|Baseline and 2 weeks||||units on a scale||Standard Error|Least Squares Mean
1344594|NCT01879371|Primary|AUC(0-tz)|AUC(0-tz): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the last quantifiable data point|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|Pharmacokinetic set (PKS): included all treated subjects who provided at least one observation for at least one primary Pharmacokinetic endpoint without important protocol violations.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1344595|NCT01879345|Secondary|AUC0-τ|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7||||ng.h/mL||Standard Deviation|Mean
1344596|NCT01879345|Secondary|Tmax - the Time of Occurrence of Cmax|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7||||hours||Standard Deviation|Mean
1344597|NCT01879345|Secondary|Cmax - Maximum Observed Plasma Drug Concentration|"Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093~Oxcarbazepine is a BIA 2-093 metabolite"|Day 1 and Day 7||||ng/mL||Standard Deviation|Mean
1344598|NCT01879345|Primary|Number of Adverse Events Reported|investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient|3 weeks||||Number of adverse events reported|||Number
1344599|NCT01879332|Primary|Number of Adverse Events Reported|Safety was evaluated through the recording and monitoring of adverse events|2 days||||Number of adverse events reported|||Number
1344600|NCT01879319|Secondary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1344601|NCT01879319|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8|Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.|Weeks 4 and 8|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
1344602|NCT01879176|Primary|IL-6||1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours||||pg/ml||Inter-Quartile Range|Median
1344603|NCT01879072|Secondary|Transplant-related Mortality (TRM)|To describe patterns of TRM post-transplant.|Two years||2018-08-31|08/2018||||
1344604|NCT01879072|Secondary|Lung Injury|To describe patterns of lung injury post-transplant.|Two years||2018-08-31|08/2018||||
1344605|NCT01879072|Secondary|Acute Liver Injury|To describe patterns of acute liver injury.|Day 100||2018-08-31|08/2018||||
1344606|NCT01879072|Secondary|Relapse/Progression|To describe patterns of relapse/progression post-transplant.|Two years||2018-08-31|08/2018||||
1344607|NCT01879072|Secondary|Infections|To describe patterns of infections through day 100.|Day 100||2018-08-31|08/2018||||
1344608|NCT01879072|Secondary|Chronic Graft-versus-host Disease (cGVHD)|To describe patterns of cGVHD including the date of onset, severity, target organ involvement and evolution of chronic graft-versus-host disease.|Two years post-transplant||2018-08-31|08/2018||||
1344609|NCT01879072|Secondary|Acute Graft-versus-host Disease (aGVHD)|To describe patterns of aGVHD using The date of onset, severity, target organ involvement, treatment, and evolution over time, including response to treatment of acute GVHD is the main outcome of interest for future testing of the collected samples.|Day 100||2018-08-31|08/2018||||
1344610|NCT01879072|Primary|Number of Participants Providing Biologic Samples|The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies.|Two years from hematopoietic stem cell transplant||||Participants|||Count of Participants
1344611|NCT01879059|Primary|Effects of Physical Inactivity on Post Prandial Blood Flow|There was a pre-measurement period of 3 days, then 5 days of inactivity, followed by 1.5-2 days of return to activity. A 10 day time frame overall. Blood flow measured by Doppler ultrasound during an oral glucose tolerance test before and after 5 days of inactivity.|10 days|healthy, young, active men|||percentage of change in blood flow||Standard Deviation|Mean
1344612|NCT01878825|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Days 0-20 post vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344613|NCT01878825|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344614|NCT01878825|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [oral temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344615|NCT01878825|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1344616|NCT01878825|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344617|NCT01878825|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1344618|NCT01878825|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344619|NCT01878825|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1344620|NCT01878825|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344621|NCT01878825|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1344622|NCT01878825|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1344693|NCT01877720|Primary|Trigger Delay|Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.|last 5-min of each 15-min trial||||ms||Standard Deviation|Mean
1344623|NCT01878825|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1344624|NCT01878812|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Titers||95% Confidence Interval|Geometric Mean
1344625|NCT01878812|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
1344626|NCT01878812|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
1344627|NCT01878812|Secondary|Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Titers||95% Confidence Interval|Geometric Mean
1344628|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|At Days 0 and 21||||Subjects|||Number
1344629|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)||||Subjects|||Number
1344630|NCT01878812|Secondary|Number of Days of Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.|||Days||Inter-Quartile Range|Mean
1344631|NCT01878812|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)||||Subjects|||Number
1344632|NCT01878812|Secondary|Number of Days of Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.|During the entire study period (Days 0 to 21)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.|||Days||Inter-Quartile Range|Mean
1344633|NCT01878812|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)||||Subjects|||Number
1344634|NCT01878812|Primary|Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Percentage of subjects|||Number
1344635|NCT01878812|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Fold increase||95% Confidence Interval|Geometric Mean
1344636|NCT01878812|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
1344637|NCT01878812|Primary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
1344638|NCT01878812|Primary|Anti-HI Antibody Titers Against 4 Strains of Influenza Disease|The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Titers||95% Confidence Interval|Geometric Mean
1344639|NCT01878799|Primary|Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)|The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.|12 weeks after completion of treatment|The analysis included all subjects who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1344640|NCT01878656|Other Pre-specified|Sense of Suffocation|The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.|||||||
1344641|NCT01878656|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.|||||||
1344642|NCT01878656|Secondary|The Time to Extubation|We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.|||||||
1344643|NCT01878656|Primary|The Incidence of Emergence Agitation Using Four-point Categorical Scale|The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.||||participants|||Number
1344644|NCT01878604|Secondary|LDL-C Reduction Percentage|"plasma LDL-C reduction percentage with lipid-lowering drugs from pre-treatment to the last time follow-up time point~plasma LDL-C reduction percentage calculation: plasma LDL-C at pre-treatment time point minus plasma LDL-C at the last time follow-up time point, and then compared with plasma LDL-C at pre-treatment time point, namely plasma LDL-C reduction percentage."|pre-treatment and 6-13 years post treatment||||percentage of plasma LDL-C reduction||Standard Error|Mean
1344645|NCT01878604|Primary|Number of LDLR Gene Mutations|"Number of gene mutations based on the sequencing results in terms of some known genes and suspected novel genes.~c.796 G>C and c.1048 C>T in the LDLR gene c.1448 G>A and c.1720C>A in the LDLR gene c.2030 G >A and c.1257 C>A in the LDLR gene homozygous mutation c.605 T>C in the LDLR gene"|1 year||||gene mutations|||Number
1344646|NCT01878526|Secondary|Changing of the Quality of Life Which is Evaluated by EQ-5DTM|VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment.|8 weeks||||VAS (100)||Standard Deviation|Mean
1344647|NCT01878526|Secondary|the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole||4 weeks|The number of analysed patients came out the total number of screening patients in the trial. The patients who were defined as omeprazole-resistant GERD were enrolled and randomized for either alginic acid plus placebo or domperidone plus placebo group.|||percentage of participants||95% Confidence Interval|Number
1344648|NCT01878526|Secondary|Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)|Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment.|8 weeks||||units on a scale||Standard Deviation|Mean
1344649|NCT01878526|Primary|Changing of the Severity of Regurgitation|VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment.|8 weeks||||VAS (100)||Standard Deviation|Mean
1344650|NCT01878526|Primary|Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)|VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment.|8 weeks||||VAS (100)||Standard Deviation|Mean
1344651|NCT01878214|Secondary|Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking|"At baseline and follow-up, subjects will answer questions about motivation to quit smoking (How motivated are you to quit smoking at this time? [scale: 1 (not at all) - 10 (extremely)]) and thinking about quitting smoking (Each rung on this ladder represents where various smokers are in their thinking about quitting. Circle the number that indicates where you are now. [0 (no thoughts of quitting) -10 (taking action to quit)]). We will report the % of subjects who reported more motivation to quit and greater thinking about quitting at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).|||percentage of participants|||Number
1344652|NCT01878214|Secondary|Changes in Readiness to Quit Smoking in the Next 6 Months|"Subjects will answer the following question at both baseline and follow-up surveys: Are you seriously considering quitting smoking in the next 6 months? [yes/no]. We will report % of subjects who said no at baseline and yes at follow-up to determine changes in readiness to quit smoking and compare between intervention and control groups."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).|||percentage of participants|||Number
1344653|NCT01878214|Secondary|Changes in Smoking Behaviors (Frequency and Quantity)|"At baseline and follow-up, subjects will report smoking frequency (How often do you smoke? [everyday, at least 4 days/week, 1-3 days/week, less than one day/week]) and quantity (On days that you smoke, how many cigarettes do you have per day? [10 or less, 11-20, 21-30, 31 or more]). We will report the % of subjects who smoke less frequently and smoke fewer cigarettes per day at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).|||percentage of participants|||Number
1344654|NCT01878214|Secondary|Quit Smoking|"At follow-up, subjects will report current smoking status. (Do you currently smoke (have you smoked in the last 30 days)? [Yes, I smoked within the past 30 days; No, but I have smoked in the past 6 months; No, and I have not smoked in more than 6 months]). We will report the % of subjects who have not smoked in the last 30 days and will compare the intervention group with the control group."|7 months after baseline|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey.|||percentage of participants|||Number
1344655|NCT01878214|Primary|Enrollment in Smoking Cessation Program|Enrollment records from the union-sponsored smoking cessation program|up to 12 months after recruitment|Includes all study subjects|||participants|||Number
1344656|NCT01878175|Secondary|Change in Lower Quarter Y-balance Test (YBT-LQ)|The YBT-LQ is a test of dynamic balance in unilateral stance . It will be administered to all patients who pass a clearance test, which consists of being able to stand on one leg for 10 seconds. The YBT-LQ is performed for both left and right limbs. Any trial that is failed will be repeated with a maximum of 4 additional trials to be performed in each reach direction, anterior, posterior, and lateral. NOTE: Only although 13 participants began the clearance test at both time points, only 5 participants were able to pass the clearance test required to do the YBT-LQ at 6 weeks. Therefore we have not provided a change score for YBT-LQ since this would involve a very small number of participants, and we are concerned about validity of the results that would be presented since those who completed the test at 6 weeks may be a biased sample. We therefore provide the difference (post minus pre) in the # of participants who completed the clearance test at 15 weeks (9) vs. 6 weeks (5).|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who performed the clearance test for the YBT-LQ at both 6 weeks and 15 weeks.|||Number of participants|||Number
1344657|NCT01878175|Secondary|Change in Harris Hip Score (HHS)|The HHS is the most widely used physician- or therapist-assessed measure of hip function following THA and associated rehabilitation. Although the HHS has also been used in a patient-report format, in this study we will obtain this measure via therapist report, to complement the patient-reported outcomes described above. This measure covers the domains of pain (severity and effects on activities and need for pain medication, function (daily activities and gait), deformity (hip flexion, adduction, internal rotation, and extremity length discrepancy) and range of motion (hip flexion, abduction, internal and external rotation, and adduction). The HHS includes 10 items, with a total score range of 0-100; higher scores indicating better function. The HHS has been shown to be a reliable and valid measure of hip function. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
1344658|NCT01878175|Secondary|Change in University of California Los Angeles (UCLA) Activity Questionnaire|The UCLA scale shows a strong correlation with the other measures (r = -0.35 to 0.56 for THA; r = -0.55 to 0.23 for TKA) and discriminates between insufficiently and sufficiently active patients undergoing THA and TKA. The UCLA scale has good reliability, provides high completion rate, and shows no floor effects. It seems to be the most appropriate scale for assessment of physical activity levels in patients undergoing total joint arthroplasty. The UCLA scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as 'no physical activity, dependent on others' and 10 defined as 'regular participation in impact sports.' Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
1344659|NCT01878175|Secondary|Change in Objective Functional Test: Stair Climbing|The task of stair climbing has been found to be sensitive to change with interventions in individuals with knee OA. This measures the time it takes a participant to ascend and descend a flight of 12 steps (each step 18 cm high and 28 cm deep). Participants will be asked to complete the test as quickly as they felt safe and comfortable. The use of one handrail will be allowed if necessary, but patients will be encouraged to minimize their use of the handrail. One practice trial will be performed and the average of two additional tests will be used for analysis. The use of an assistive device will be allowed only if the subject will be unsafe or cannot complete the test without the use of the device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this measure at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.|||seconds||Standard Deviation|Mean
1344660|NCT01878175|Secondary|Change in Objective Functional Test: Walking Speed|Gait speed is a global measure of disability and function and has been correlated with disease processes, fitness level, activities of daily living, and emotional states. In addition, gait speed is an imperative measure for integration to safe and effective community ambulatory status, and has been defined as a reflective measure of function. Walking speed will be determined as the average walking speed over a 3 meter walk. Participants will be asked to walk down a 10 meter walkway 7 times (while wearing standard footwear) to have their walking speed monitored using infrared photocells, while speed is monitored over the middle 3 meters. These seven trials will be averaged in order to determine walking speed at each of the three visits. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.|||m/sec||Standard Deviation|Mean
1344661|NCT01878175|Secondary|Change in Objective Functional Test: Sit to Stand|The Sit-to-Stand Test has been reported to be a good indicator of postural control, fall risk, lower-extremity strength, and disability. During the sit-to-stand test participants will be asked to place their arms across their chest and keep their feet flat on the floor. They will then be asked to stand up and sit down 5 times as fast as they can. This will be repeated twice and the scores will be averaged for analysis. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at 6 and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this test at both time points.|||seconds||Standard Deviation|Mean
1344662|NCT01878175|Secondary|Change in Objective Functional Test: Timed Get Up-and-go|The timed get up-and-go test has demonstrated excellent reliability and correlates well with other standard measures such as gait speed, self-report and clinical report indices of function, and is predictive of who can safely ambulate. This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Participants are asked to complete this as quickly and safely as possible, without the use of an assistive device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at both 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this assessment at both time points.|||seconds||Standard Deviation|Mean
1344663|NCT01878175|Secondary|Global Assessment of Hip Symptom Change|We will use the Patient Global Impression of Change scale to evaluate participants' perspectives on overall change in their joint pain in their (one) operative hip during the study period. This single-item measure asks participants to describe their change in pain on a rating scale with the following 13 options: a little worse, somewhat worse, moderately worse, a good deal worse, a great deal worse, a very great deal worse, about the same, a little better, somewhat better, moderately better, a good deal better, a great deal better, a very great deal better. The total scale range is -6 to +6. Negative scores indicate greater perceived improvement.|15 weeks (post-intervention)|Number of participants who completed this measure at 15 week follow-up. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this item at the 15 week follow up assessment.|||units on a scale||Standard Deviation|Mean
1344664|NCT01878175|Secondary|Change in Satisfaction With Physical Function Questionnaire|This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity osteoarthritis (OA), including stair-climbing, walking, doing housework (light and heavy), and lifting and carrying. The scale range is -15 to +15, with higher scores indicating more satisfaction with function. Change was defined as post-intervention minus pre-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the measure at baseline and 15 weeks. Two participants were withdrawn before 15 weeks.|||units on a scale||Standard Deviation|Mean
1344665|NCT01878175|Primary|Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Quality of Life scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
1344666|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Symptoms subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
1344667|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Sport subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete all items on this subscale at both time points and therefore could not be given a score, per scale scoring instructions.|||units on a scale||Standard Deviation|Mean
1344668|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS pain subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
1344669|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Individuals who completed the HOOS ADL scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
1344670|NCT01878149|Secondary|Safety|Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.|Observed for up to 6 months post-surgery|||||||
1344671|NCT01878149|Primary|Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures|Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.|Observed for up to 6 months post-surgery|It was anticipated that approximately 40 subjects would be enrolled across the participating sites; 20 subjects in each treatment arm. Consecutive subjects who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the the data collection were included. The planned sample size was not statistically derived.|||participants|||Number
1344672|NCT01878097|Secondary|Social Networks|Measure of how the bystander intervention is diffused throughout student social networks. Each trained student provides the names of 5 friends / acquaintances. Analyses measures the numbers of students indirectly receiving training via trained student. Panel surveys also measure impact of diffusion through observing others' bystanding behaviors|Annual measures violence at baseline (pre-intervention) and 4 years post intervention|No usable data were collected.||||||
1344673|NCT01878097|Secondary|Violence Acceptance|Two measures used: Illinois Rape Myth Acceptance Scale measure students' beliefs about rape which may indicate social norms supporting sexual violence. 5-item Acceptance of General Dating Violence Scale(21) was used to measure norms supporting dating violence.|Annual measures violence at baseline (pre-intervention) and 4 years post intervention||2018-10-31|10/2018||||
1345090|NCT01871090|Primary|Time to Interrogation|Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.|On day of Emergency Department admission||||Minutes||Full Range|Median
1344674|NCT01878097|Secondary|Increase in Bystanding Behaviors|"7 items measuring self-reports of students actively engaging their peers in behaviors that may prevent violence.~Response options: 0 times, 1-2 times, 3-5 times, 6-9 times, 10 or more times, didn’t see or hear someone doing this~Tell someone to stop talking down to, harassing, or messing with someone else.~Speak up when you heard that someone who was forced to have sex or hurt by a boyfriend/girlfriend was to blame.~Talk to a friend who was being physically hurt by a boyfriend/girlfriend.~Ask someone that looked very upset at a party if they were okay or needed help.~Ask a friend if they needed to be walked or driven home from a party if they looked upset.~Spoke up to someone who was bragging or making excuses for forcing someone to have sex with them.~Got help for a friend because they had been forced to have sex or were physically hurt by a boyfriend/girlfriend.~Above items repeated to measure student observing others doing these behaviors."|Annual measures violence at baseline (pre-intervention) and 4 years post intervention||2018-10-31|10/2018||||
1344675|NCT01878097|Primary|Average Number of Sexual Assaults Experienced (Victimization) Events Per School.|Students self report of sexual assault victimization averaged at the school level and adjusted for baseline and number of students. Adjustments made by including baseline measure and number of students as covariates in models.|over 5 years with baseline intervention|anonymous survey data collected over 5 years and sorted by intervention. To keep ITT analysis, all schools were included and data were imputed for schools that dropped out.|||Number of events per school|Schools|95% Confidence Interval|Least Squares Mean
1344676|NCT01878097|Primary|Average Number of Sexual Assault Events Used (Perpetrated) Per School.|Students self report of sexual assault perpetration averaged at the school level and adjusted for baseline and number of students. Adjustments were made by including baseline measure and number of students as a covariate in the model.|over 5 years with baseline intervention|Anonymous survey data collected over 5 years and sorted by intervention. To complete ITT analysis, schools that dropped out were included in analysis using imputed data.|||Number of events per school|Schools|95% Confidence Interval|Least Squares Mean
1344677|NCT01877941|Primary|Cardiac Output as Measured by ECOM|Measurements of cardiac output derived from the Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.|During and post-surgery, up to 8 hours|Supplies for the ECOM device were not available so it was not tested.||||||
1344678|NCT01877941|Primary|PAC (Pulmonary Artery Catheter).|"Measurements of cardiac output derived from a PAC (pulmonary artery catheter) using the standard thermodilution technique. At each time point, at least 6 measurements were taken. If, in the opinion of the clinician taking the readings, some of these were in error, more readings were taken to ensure accuracy. In no case were more than 18 readings taken. The points deemed valid by the clinician were averaged to obtain the reference value for that time point. The mean and standard deviation reported consisted of the reference values from all time points measured.~Data for this test were taken at the following timepoints:~1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and post-surgery, up to 24 hours||||liters/minute||Standard Deviation|Mean
1344679|NCT01877941|Primary|esCCO (Estimated Continuous Cardiac Output) Monitor|"6 Measurements of cardiac output derived from pulse oximeter measurements using the esCCO system were taken at each time point. The measurements deemed valid under the criteria in the protocol were averaged to represent the reference value at that point. The mean and standard deviation reported consist of the reference values from all time points measured.~Data for this test were taken at the following timepoints:~1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and after surgery, up to 24 hours||||liters/minute||Standard Deviation|Mean
1344680|NCT01877720|Secondary|Respiratory Rate||last 5-min of each 15-min trial|||||||
1344681|NCT01877720|Secondary|Blood Pressure|systolic, diastolic and mean blood pressure measured by non-invasive cuff|last 5-min of each 15-min trial|||||||
1344682|NCT01877720|Secondary|Heart Rate||last 5-min of each 15-min trial|||||||
1344683|NCT01877720|Secondary|SpO2|transcutaneous peripheral saturation of oxygen by pulse oximeter|last 5-min of each 15-min trial|||||||
1344684|NCT01877720|Secondary|Asynchrony Index|"total number of each event per minute~ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization~auto-triggering: a cycle delivered by the ventilator without EAdi signal~premature cycling~delayed cycling: VPT > NIT x2~double triggering~Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100"|last 5-min of each 15-min trial||||percentage of neural respiration||Inter-Quartile Range|Median
1344685|NCT01877720|Secondary|All Asynchrony Events||last 5-min of each 15-min trial||||events per min||Inter-Quartile Range|Median
1344686|NCT01877720|Secondary|Leakage|[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)|last 5-min of each 15-min trial||||percentage of inspiratory tidal volume||Standard Deviation|Mean
1344687|NCT01877720|Secondary|Swing EAdi||last 5-min of each 15-min trial||||uV||Standard Deviation|Mean
1344688|NCT01877720|Secondary|Maximum EAdi||last 5-min of each 15-min trial||||uV||Standard Deviation|Mean
1344689|NCT01877720|Secondary|Pneumatic Respiratory Rate||last 5-min of each 15-min trial||||breaths per min||Standard Deviation|Mean
1344690|NCT01877720|Secondary|Peak Inspiratory Pressure||last 5-min of each 15-min trial||||cmH2O||Standard Deviation|Mean
1344691|NCT01877720|Secondary|Minute Ventilation Volume|inspiratory tidal volume / respiratory rate|last 5-min of each 15-min trial||||mL/kg/min||Standard Deviation|Mean
1344692|NCT01877720|Secondary|Ti_excess (Inspiratory Time in Excess)|"Ti_excess = (VPT-NIT)/NIT~VPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value"|last 5-min of each 15-min trial||||percentage of neural inspiratory time||Standard Deviation|Mean
1345134|NCT01870778|Primary|Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180|The percentage of participants with an adjudicated CV death through day 180 was assessed.|180 days|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
1344694|NCT01877668|Secondary|Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score>0 cm and were evaluable. n=number of participants evaluable at each visit.|||cm||Standard Error|Least Squares Mean
1344695|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344696|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score|FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344697|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score|FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (“washed out”), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344698|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||mm||Standard Error|Least Squares Mean
1344699|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344700|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit|||Units on a scale||Standard Error|Least Squares Mean
1344701|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344702|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344703|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual’s rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344704|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344705|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344706|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344707|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344737|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Pulse Oximetry for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for pulse oximetry following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
1344708|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344709|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344710|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344711|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344712|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344713|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344714|NCT01877668|Secondary|Change From Baseline in the Leeds Enthesitis Index (LEI)|Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0–6. Higher score indicates a greater number of sites that are affected by enthesitis.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline LEI>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344715|NCT01877668|Secondary|Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index|The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344716|NCT01877668|Secondary|Change From Baseline in Dactylitis Severity Score (DSS)|Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0–3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline DSS>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344717|NCT01877668|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12|PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.|At Months 1, 3, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug with PASI>0 and BSA ≥3% at baseline. n=number of responders.|||Percentage of participants|||Number
1344718|NCT01877668|Secondary|Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response|The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344719|NCT01877668|Secondary|Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician’s Global Assessment of Arthritis, and the Patient’s Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician’s Global Assessment of Arthritis; ≥20% improvement in Patient’s Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
1344720|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count|Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Joints||Standard Error|Least Squares Mean
1344721|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count|Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Joints||Standard Error|Least Squares Mean
1344722|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis|The blinded investigator or qualified assessor assessed how the participant’s overall arthritis appeared at the time of the visit. This was an evaluation based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
1344723|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis|Participant answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
1344724|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
1344725|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mg/L||Standard Error|Least Squares Mean
1344726|NCT01877668|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.|From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
1344727|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
1344728|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
1344729|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
1344730|NCT01877668|Secondary|Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12|Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline.|At Month 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Percentage of participants|||Number
1344731|NCT01877668|Secondary|Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis|Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.|From Baseline to Month 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344732|NCT01877668|Primary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.|From Baseline to Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
1344733|NCT01877668|Primary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).|At end of Month 3|All participants who were randomized and received at least 1 dose of study drug.|||Percentage or participants|||Number
1344734|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Cogscreen Pathfinder Response for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for Cogscreen Pathfinder Response following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
1344735|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Diastolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for diastolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
1344736|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Heart Rate for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for heart rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
1344752|NCT01877408|Secondary|Pain Experienced|Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain|Within 2 days after surgery||||units on a 10-point pain scale||Standard Deviation|Mean
1344738|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Sedation for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for sedation based on a 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake) following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine)|24 hours|Pharmacodynamics Population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
1344739|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Systolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for systolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamics Population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
1344740|NCT01877642|Primary|Relative Pharmacodynamic Effect on Respiration Rate for Combined vs Individual (Lorazepam, Loxapine)|LS Mean ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for respiration rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine)|24 hours|Pharmacodynamics Population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
1344741|NCT01877642|Primary|Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg|Determine the maximum level of sedation for Lorazepam 1 mg IM + ADASUVE 10 mg based on the 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake)|24 hours|Open label population|||units on a scale||Standard Deviation|Mean
1344742|NCT01877564|Primary|IHC-based Tissue Markers of Proliferation||1 year|data were not collected||||||
1344743|NCT01877538|Primary|Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE|"SUV values were calculated in 7 internal organs. SUV is a unitless ratio. We normalised to injected dose and bodyweight.~SUV (organ) = activity concentration (organ; kBq/mL) * bodyweight (mL) / injected dose (kBq)~Note: it is a common assumption when calculating SUV values that bodyweight equals volume, and therefore the unit mL is appropriate."|1 day (one timepoint)|In 6 subjects the SUV values in internal organs were calculated.|||Unitless ratio||Standard Deviation|Mean
1344744|NCT01877538|Primary|Distribution Volume (DV) of [11C]Donepezil - BASELINE|Logan's graphical analysis is used to calculate Distribution Volumes in Volumes of interest in internal organs (salivary gland, heart, liver, stomach, intestines, kidneys). Arterial blood sampling with radio metabolite correction is performed.|1 day (One timepoint)|In 6 subjects we analysed Volumes of distribution (Vd) and SUV values in internal organs (parotid, submandibular, spleen, stomach, heart, intestine, pancreas). NOTE: In subject number 7 we examined radioactive dose in 23 target organs (dose: microSv/MBq) and calculated the combined effective dose. The Vd and SUV values listed are from 6 subjects.|||mL||Standard Deviation|Mean
1344745|NCT01877421|Secondary|Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a|"Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a.~Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis."|days 0, 14, 28, 34||||Percent of bleeding sites||Standard Deviation|Mean
1344746|NCT01877421|Secondary|Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a|"Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae.~Modified Gingival Index Scores:~0 Absence of inflammation~Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit~Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit~Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit~Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration."|days 14, 28, 34||||scores on a scale||Standard Deviation|Mean
1344747|NCT01877421|Secondary|Proof of Concept of KSL-W in Reducing Plaque in Phase 2a|"Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index.~Quigley-Hein Plaque Index Scores with Turesky Modifications:~0 No plaque~Separate flecks of plaque at the cervical margin of the tooth~A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth~A band of plaque wider than one mm but covering less than one-third of the crown of the tooth~Plaque covering at least one-third but less than two thirds of the crown of the tooth~Plaque covering two-thirds or more of the crown of the tooth"|days 14, 28, 34||||scores on a scale||Standard Deviation|Mean
1344748|NCT01877421|Primary|Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)|Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)|Up to 28 days||||Participants|||Count of Participants
1344749|NCT01877408|Other Pre-specified|Number of Participants With Adverse Events|Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 year||||participants|||Number
1344750|NCT01877408|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)|Within 6 weeks after surgery||||participants|||Number
1344751|NCT01877408|Secondary|Overall Patient Satisfaction|"Patient satisfaction evaluated with questionnaire using satisfaction scale~Very satisfied~Satisfied~Not satisfied"|Within 6 weeks after surgery||||participants|||Number
1344754|NCT01877408|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey based on 5 point Likert scale~Unicirc is much easier~Unicirc is easier~Neutral~Open surgical is easier~Open surgical is much easier"|1 year|The four physicians that participated in this study performed both procedures (i.e. open surgical and Unicirc) on study participants. Three physicians had significant previous (non-study) experience performing open surgical circumcisions. All four had no to very limited previous experience performing Unicirc circumcisions.|||units on Likert scale||Full Range|Median
1344755|NCT01877408|Primary|Intraoperative Duration|Amount of time from first manipulation of tissue under local anesthesia to dressing|1 hour||||minutes||Inter-Quartile Range|Median
1344756|NCT01877343|Primary|Pulse Strength|Continuous change of pulse strength from baseline through the end of the study. Pulse strength is measured as volts by the system. Changes in pulse strength will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. Cardiac function curves will be constructed with the data collected and average pulse strength from baseline to 30 minutes will be reported.|Average pulse strength from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.||||||
1344757|NCT01877343|Primary|Pulse Rate|Continuous change of pulse rate from baseline through the end of the study will be followed. Changes in pulse rate will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. From the graph, average pulse rate is calculated.|Average pulse rate from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.||||||
1344758|NCT01877278|Primary|Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4|"Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis.~The WOMAC consists of 24 items divided into 3 subscales:~Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome."|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1344759|NCT01877278|Primary|Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4|visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1344760|NCT01877161|Primary|The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)|"Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus).~Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus.~The reaction time post TMS - reaction time pre TMS were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG"|change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)||||msec||Standard Deviation|Mean
1344761|NCT01877148|Other Pre-specified|Change From Jebsen-Taylor Hand Function Test - Jebsen Test|The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function|At baseline, after 1 month||||minutes||Standard Error|Mean
1344762|NCT01877148|Other Pre-specified|Change From Parkinson Disease Quality of Life - PDQL|"Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome), as accurate and appropriate"|at baseline, after 1 month||||units on a scale||Standard Error|Mean
1344763|NCT01877148|Secondary|Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation||per sesssion: at baseline and after physical therapy||||milivolt||Standard Error|Mean
1344764|NCT01877148|Primary|Change From Unified Parkinson´s Disease Rating Scale - UPDRS|"Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome), as accurate and appropriate"|At baseline, after 1 month||||units on a scale||Standard Error|Mean
1344765|NCT01876992|Other Pre-specified|Effect of Dose Escalation|Compare the effect of dose escalation of metformin on CBP phosphorylation in white blood cells in both in vivo and ex vivo assays to subsequent physiological changes in vivo for adults and children. CBP phosphorylation will be measured by western blot analysis using a probe that is specific for the phosphorylated CBP protein. The outcome will be the % difference between the patient before starting metformin and at each dose increment.|Approximately Week 10|Escalating CBP phosphorylation was measured.|||percent phosphorylation||Full Range|Mean
1344766|NCT01876992|Secondary|Fasting Blood Glucose.|A fasting blood sugar level less than 100 mg/dL is normal. A fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes. If a subject has a blood sugar of 126 mg/dL or higher on two separate tests, they are diagnosed with diabetes. Metformin decreases fasting blood sugar.|30 days|Data were not collected for this outcome measure.||||||
1344767|NCT01876992|Secondary|Change in BMI|The BMI is an index measure of body weight and is used to define states of obesity. Height ( in meters) and weight (in Kilograms) are used to calculate a BMI (kg/m2).|Baseline and after about 30 days||||change in BMI (kg/m2)||Full Range|Mean
1345135|NCT01870739|Secondary|Number of Patients With Reported Adverse Events, Serious Adverse Events and Death|This outcome measure summarizes patients with any adverse events, serious adverse events and death.|12 weeks|Safety analysis set: All patients that received study drug|||Patients|||Number
1344768|NCT01876992|Primary|% Cyclic Amine Mono Phosphate (cAMP) Response Element Binding Protein (CBP) White Blood Cell (WBC) Phosphorylation (Metformin Treated vs no Treatment)|To assess metformin-induced Cyclic Amine Mono Phosphate (cAMP) response element binding protein (CBP) phosphorylation in circulating white blood cells both in vivo and ex vivo and determine its relationship to subsequent changes in body mass index, fasting blood glucose.|10 weeks||||percent phosphorylation||Full Range|Mean
1344769|NCT01876979|Primary|Time|Time duration for the application of device, in minutes.|Time duration of placement of device in operating room||||minutes||Full Range|Mean
1344770|NCT01876823|Other Pre-specified|Conversion to Dementia Using Clinical Dementia Rating (CDR)|The CDR is a numeric rating scale that is used to quantify the severity of one's cognitive function. The scale goes from 0=normal; 0.5=mild cognitive impairment; 1 to 3=mild to moderate/severe dementia. CDR was used a dichotomous outcome measure (no=0; yes=1).|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).|||participants|||Number
1344771|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Cognitive Change|The CGI Cognitive Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses from the entire group were calculated. Mean at final visit and baseline is reported below.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).|||units on a scale||Standard Deviation|Mean
1344772|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Depression Change|The CGI Depression Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses were calculated for the entire group. Mean at final visit has been reported below. Higher mean at baseline indicates a decrease in depression scores.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).|||units on a scale||Standard Deviation|Mean
1344773|NCT01876823|Other Pre-specified|Change in Treatment Emergent Side Effects (TESS)|"Somatic side effect rating scale which includes 26 common somatic side effects associated with previous medication clinical trials; rated by the study physician. Factors were dichotomized to yes or no responses on this scale, which equated to the symptom being either present or not present. Yes and no responses were given a value of 0 (no) or 1 (yes). Responses from the entire group were calculated and the mean at baseline and the last visit is reported below."|Baseline, Week 48|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
1344774|NCT01876823|Other Pre-specified|Change in 24-item HAMD|Change in 24-item Hamilton Rating Scale for Depression (HAMD) scores from baseline to Week 48: HAMD measures depression severity based on a series of 24 items items. The range of HAMD total score is 0-74; 0 indicates no depressive symptoms and a maximum HAMD score is a 74, where the greater the score indicates more significant psychopathology. In this study, moderate to severe depression is considered a HAMD-24 greater than 14.|Baseline, Week 48|Analysis was intent to treat.|||scores on a scale||Standard Deviation|Mean
1344775|NCT01876823|Secondary|Change in Trails A|Change in Trails A scores from baseline to Week 48: Measures attention and executive function. It asks patients to connect numbers from 1-25 in numerical order as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.|||seconds||Standard Deviation|Mean
1344776|NCT01876823|Secondary|Change in Trails B|Change from baseline to Week 48 on Trails B: Measures attention and executive function. It asks patients to connect numbers and letters in numerical to alphabetical order from (1-13 and A-L) as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers and letters, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.|||seconds||Standard Deviation|Mean
1344777|NCT01876823|Secondary|Change in Selective Reminding Test - Delayed Recall (SRT-DR)|Change in Selective Reminding Test-Delayed Recall scores from baseline to Week 48: SRT Delay is administered 15 minutes after the immediate recall portion. Patients are asked to remember as many of the words as they can from the 6 trials. Maximum raw score is a 12 for free recall. If a patient is unable to recall a word, they are given a chance to recognize it among three incorrect word choices. Maximum raw score for recognition is 12. The greater the score on the delayed recall portion, the better the patient does on the assessment.|Baseline, Week 48|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
1344778|NCT01876823|Secondary|Change in Wechsler Memory Scale-III (WMS-III)|Change in Wechsler Memory Scale-III scores from baseline to Week 48: The WMS-III Visual Reproduction sub-test was used to measure visual working memory and delayed memory. Patients were shown pictures of four drawings and were asked to reproduce them from memory immediately after seeing them, and 25 minutes after seeing them. The four scores are summed and the greater the total raw score, the better the patient did on the assessment. The maximum raw score for this test is a 41 on both the immediate and delayed portions (the overall range is 0-82 points). The change score is calculated using the total scores of both the immediate and delayed portions.|Baseline, Week 48|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
1344779|NCT01876823|Primary|Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)|Change in Selective Reminding Test-Total Immediate Recall (SRT-IR) scores from baseline to Week 48: Measures word recall (maximum 12 words per trial, across 6 trials). Maximum total recall score across 6 trials is 72; minimum recall is 0 across 6 trials. The higher the raw score, the better the patient did at recalling the target words. The unit of measure is the raw score, or the sum of the number of words recalled across all 6 trials.|baseline, 48 weeks|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
1344780|NCT01876810|Other Pre-specified|Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment|In this study, each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were then seated in a comfortable chair and completed the baseline Visual Analogue Scale for craving 0-100 mm (The higher the number the more is the craving). The smoking cue was a pack of cigarettes and a lighter. Participants were instructed to light the cigarette without puffing and hold it for 30 sec while the physiological recordings were measured. Then the participant was asked to extinguish the cigarette. The neutral cue was an unsharpened pencil, a notepad, and a sharpener. Participants were instructed to sharpen the pencil and hold it as if writing for 30 sec. Participants completed the Visual Analogue Scale for craving during the cue, and 15 and 30 min after cue presentation.|during the lab Cue- reactivity paradigm after 1 week of treatment|participants self-reportd Visual analogue scale (0-100 mm) for craving at the time of presenting the smoking cue. The higher the number on the scale, the more is the craving|||units on a scale: from 0-100 mm||Standard Error|Mean
1344781|NCT01876810|Secondary|The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment|"Percentage of choice of Nicotinized cigarettes was calculated for each participant during the lab session which took place after 1 week of treatment.~Each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were asked to complete some questionnaires at baseline. Then, they were asked to relax for 30 min listening to music or reading. Four exposure trials followed that were separated by 30 min of relaxation. In each exposure trial, participants took four puffs of a Nicotinized (A) or Denicotinized (less than 0.05 mg nicotine.) (B) cigarette in the order of ABAB or BABA. Cigarettes were color-coded. Participants then began four choice trials separated by 30 min of relaxation. In each trial, participants chose any combination of 4 puffs from the two cigarettes."|during the lab forced choice paradigm after 1 week of treatment||||percentage of choice of nicotinized ciga||Standard Error|Mean
1344782|NCT01876810|Primary|Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks|the number of days of no smoking was calculated for each participant. Abstinence was verified by daily Self-reports of no smoking and breath carbon monoxide < 5 ppm|1 week in each phase||||days||Standard Error|Mean
1344783|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of CL/F|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
1344784|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of AUCss|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
1344785|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of Cmax|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
1344786|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of V/F.|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
1344787|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Overall Survival|Once 155 progression events have occurred when 25% of randomized patients have died due to any cause.|Estimated time frame at 20 months after initial 25.5 months.|||||||
1344788|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Change in Tumour Size|Once 155 progression events have occurred.|Assessed tumour size at screening, Weeks 7, 8 and then every 12 weeks thereafter and at Discontinuation visit, estimated time frame at 25.5 months.|||||||
1344789|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Objective Response Rate.|Once 155 progression events have occurred.|Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization|||||||
1344790|NCT01876784|Secondary|Evaluation of the Safety and Tolerability of Vandetanib Treatment in the Patient Population by Assessment of Adverse Events, Vital Signs, Laboratory Parameters and Electrocardiography.|Once 155 progression events have occurred.|Safety assessments at baseline, Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter|||||||
1344791|NCT01876784|Secondary|Demonstration of an Improvement in Time to Worsening of Pain in Patients Treated With Vandetanib When Compared to Placebo in the Patient Population.|Once 155 progression events have occurred.|Patient assessments at baseline, week 4, 8, 12 and then every 12 weeks thereafter, assess up to 25.5 months|||||||
1344792|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Duration of Response.|Once 155 progression events have occurred.|Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization|||||||
1344793|NCT01876784|Primary|Progression-Free Survival (PFS)|The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed by Kaplan-Meier method.|Randomization until disease progression or death, assessed every 12 weeks (up to 22 months)|Intent to treat population included all randomized participants.|||months||95% Confidence Interval|Median
1347059|NCT01840605|Secondary|Change From Baseline in Pruritus Score|The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|Baseline and 1 weeks||||units on a scale||Standard Error|Least Squares Mean
1344794|NCT01876732|Secondary|Change in Quality of Life|The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.|3 month|Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared.|||Scores on a Scale||Standard Deviation|Mean
1344795|NCT01876732|Primary|Change in Amount of Epogen Required|The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients|Baseline and 4 months||||unit/ml||Standard Deviation|Mean
1344796|NCT01876706|Secondary|QMAX Median at Baseline and 12 Months With CI 95%|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.|12 Month||||mL/sec||95% Confidence Interval|Median
1344797|NCT01876706|Secondary|IPSS at Baseline and 12 Months, Median , 95% CI|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.~Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Month||||IPSS total score||95% Confidence Interval|Median
1344798|NCT01876706|Secondary|BPHII Baseline and 12 Month Median Score, 95% CI|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month||||BPHII total score||95% Confidence Interval|Median
1344799|NCT01876706|Secondary|Pain Tolerability Throughout the UroLift System Procedure|Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.|12 Month|Pain Tolerability throughout the UroLift System Procedure|||units on a scale||Full Range|Mean
1344800|NCT01876706|Secondary|QMAX 12 Month Percent (%) Change in mL/Sec From Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.|||percentage change||95% Confidence Interval|Mean
1344801|NCT01876706|Secondary|QMAX 12 Month Change Minus Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.|||mL/sec||Standard Deviation|Mean
1344802|NCT01876706|Secondary|Qmax Scores at Baseline and 12 Month Follow-up|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.|12 Month|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.|||mL/sec||Standard Deviation|Mean
1344803|NCT01876706|Secondary|BPH II 12 Month Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months||||BPHII total score||Standard Deviation|Mean
1344816|NCT01876420|Primary|Device Success Rate at 24 Hours to Seven Days|"Device success rate at 24 hours to seven days, defined as:~Absence of procedural mortality, AND~Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND~Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity < 3 m/sec), AND absence of moderate or severe prosthetic valve regurgitation.~The percentage of subjects with no more than mild aortic regurgitation at early post procedure echocardiogram (24 hours through seven days)."|24 hours to seven days|All implanted subjects at 30 days.|||percentage of participants|||Number
1344804|NCT01876706|Secondary|BPH II 12 Month Percent (%) Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months||||percentage change||95% Confidence Interval|Mean
1344805|NCT01876706|Secondary|BPH II Scores at Baseline and 12 Month Follow-up|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month||||BPHII total score||Standard Deviation|Mean
1344806|NCT01876706|Secondary|IPSS 12 Month Percent (%) Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.~The larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject."|12 Months||||percentage change||95% Confidence Interval|Mean
1344807|NCT01876706|Secondary|IPSS 12 Month Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.~The larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS."|12 Months||||scores on a scale||Standard Deviation|Mean
1344808|NCT01876706|Secondary|IPSS Scores at Baseline and 12 Month Follow-up|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.~Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Months||||IPSS total score||Standard Deviation|Mean
1344809|NCT01876706|Primary|Quality of Recovery|Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.|1 Month||||participants|||Number
1344810|NCT01876420|Secondary|Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy.|Resheath or Recapture success rate (when attempted), where successful recapture is defined as Evolut R™ TAV (including the frame) is fully resheathed into the capsule of the delivery catheter, as verified by fluoroscopy. Resheathing or recapturing of the TAV was attempted on 15 subjects.|Day 1|Subjects who had either a resheath or recapture attempt at implant and the success rate for each resheathing, or recapturing attempts of the valve at the implant.|||percentage of successful attempts|Research recapture attempts||Number
1344811|NCT01876420|Secondary|Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)|Degree of Total prosthetic valve regurgitation (transvalvular & paravalvular)|30 days|All implanted subjects who had echos at the 30 day visit, which were 58 subjects, and 58 of the echos were able to measure the Total Aortic Regurgitation for those subjects.|||percentage of participants|||Number
1344812|NCT01876420|Secondary|Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)|Effective orifice area|30 days|All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 54 of the echos were able to measure the EOA for those subjects.|||cm²||Standard Deviation|Mean
1344813|NCT01876420|Secondary|Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient|The hemodynamic performance will be measured by the Mean Prosthetic Valve Gradient for 59 subjects, measured with the Doppler echocardiography.|30 days|All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 57 of the echos were able to measure the Mean Gradient for those subjects.|||mmHg||Standard Deviation|Mean
1344814|NCT01876420|Secondary|Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days|The Individual components of the VARC II composite safety endpoint at 30 days per the Kaplan Meier Event Rate (%).|30 days|The number of subjects analyzed at 30 days.|||percentage of probability|||Number
1344815|NCT01876420|Secondary|VARC II Combined Safety Endpoint at 30 Days|The VARC II Combined Safety Endpoint at 30 days includes the following components: All-Cause Mortality, All Stroke, Life Threatening or Disabling Bleeding, Acute Kidney Injury: Stage 2 or 3, Coronary Artery Obstruction, Major Vascular Complication, and Valve-Related Dysfunction Requiring Repeat Procedure.|30 days||||percentage probability|||Number
1344857|NCT01875510|Primary|Number of Participants With Retinopathy of Prematurity|The number of Participants with Retinopathy of Prematurity will be defined.|Corrected age 32 weeks or postnatal 28th day||||participants|||Number
1344858|NCT01875471|Primary|Subjective Ease of Lens Removal|After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).|Day 7||||participants|||Number
1344817|NCT01876420|Primary|Stroke Rate (Disabling and Non-disabling) at 30 Days|The Stroke rate (disabling and non-disabling) at 30 days per the VARC II definitions. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Stroke may be classified as ischaemic or haemorrhagic with appropriate subdefinitions. Ischaemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Haemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid haemorrhage. A stroke may be classified as ‘undetermined’ if there is insufficient information to allow the categorization as ischaemic or haemorrhagic.|30 days|All implanted subjects at 30 days.|||percentage of participants|||Number
1344818|NCT01876420|Primary|All-cause Mortality Rate at 30 Days|"The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically:~Cardiovascular mortality (Any of the following criteria)~Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure)~Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease~All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure~All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events~Sudden or unwitnessed death~Death of unknown cause Non-cardiovascular mortality~Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)"|30 days|All implanted subjects at 30 days.|||percentage of participants|||Number
1344819|NCT01876381|Secondary|Change From Baseline in Total Fluid Removal Per Week by Dialysis|The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics.|Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)||||ml||Standard Deviation|Mean
1344820|NCT01876381|Primary|Change From Baseline in Daily Urine Volume|The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation [SD], minimum, median, maximum [same for following parameters]).|Baseline and Day 14 (Intermittent Administration Period)||||ml||Standard Deviation|Mean
1344821|NCT01876368|Secondary|Number of Patients With Total Adverse Events, Serious Adverse Events and Death|Number of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization.|||Number of participants|||Number
1344822|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response|Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS|||Participants|||Number
1344823|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response|Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS|||Participants|||Number
1344824|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control|Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||Participants|||Number
1344825|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control|Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||Participants|||Number
1344826|NCT01876368|Secondary|Number of Patients Achieving Successful Overall Blood Pressure Control|Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS|||Participants|||Number
1344827|NCT01876368|Secondary|Change From Baseline in Office Pulse Pressure|Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
1344828|NCT01876368|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
1344829|NCT01876368|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
1344830|NCT01876368|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1344831|NCT01876368|Primary|Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis|||mmHg||Standard Error|Least Squares Mean
1344832|NCT01876329|Secondary|Presence of Anti-GPC Antibodies|Hypothesis: Evidence of anti-GPC Ab in a group of patients with RA will be more prevalent as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.|7 months||||participants|||Number
1344833|NCT01876329|Primary|Prevalence of Vitamin B12 Deficiency|Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.|7 months||||participants|||Number
1344834|NCT01875991|Secondary|Strength of Preference for Autoinjector A and Autoinjector B|Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8. After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).|Week 8|Primary Analysis Set|||percentage of participants|||Number
1344835|NCT01875991|Secondary|Pain Associated With Use of the Autoinjector|"Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject’s Experience with the Autoinjector Questionnaire: Using this scale, select the circle that best describes how much it hurt when giving yourself an injection. Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst). The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
1344836|NCT01875991|Secondary|Satisfaction|"Satisfaction was assessed based on responses to questions 11 and 12 of the Subject’s Experience with the Autoinjector Questionnaire. Question 11: How dependable (durable, sturdy, reliable) did you feel the autoinjector device was? answered on a scale from 1 (Not at all) to 5 (Very much). Question 12: Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept? answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend). The percentage of participants who scored either a 4 or 5 on each question is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
1344837|NCT01875991|Secondary|Discomfort|"Discomfort was assessed based on responses to Question 9 of the Subject’s Experience with the Autoinjector Questionnaire: How much discomfort did you experience when giving yourself the medicine using the autoinjector? Participants answered on a scale from 1 (None) to 5 (Very much). The percentage of participants who scored a 1 (None) or 2 (A little) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
1344838|NCT01875991|Secondary|Convenience|"Convenience was assessed based on responses to Question 8 of the Subject’s Experience with the Autoinjector Questionnaire: How convenient was the autoinjector to use? Participants answered on a scale from 1 (Not at all) to 5 (Very much). The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
1344839|NCT01875991|Secondary|Certainty of Completing the Injection With the Autoinjector|"Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject’s Experience with the Autoinjector Questionnaire: How certain were you that you knew when the injection was finished? Participants answered on a scale from 1 (Not at all) to 5 (Extremely). The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
1344840|NCT01875991|Secondary|Ease of Use|Ease of use was assessed based on responses to questions 1 to 6 of the Subject’s Experience with the Autoinjector Questionnaire: 1. How easy was it to learn how to use the autoinjector? 2. How easy was it for you to press the button to start the injection? 3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection? 5. How easy was it for you to inject yourself using the autoinjector? 6. How easy was it to follow the progress of the injection? Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy). The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
1344841|NCT01875991|Secondary|Change From Baseline in Needle Apprehension at Week 4|"Participants' needle apprehension was assessed using the Subject’s Perception of Self-Injecting Questionnaire. Participants answered the question Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector using a scale from 1 (extremely nervous) to 5 (not at all nervous)."|Baseline and Week 4|"Full analysis set, which included all randomized participants. n indicates the number of participants with available data."|||units on a scale||Standard Deviation|Mean
1344842|NCT01875991|Primary|Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B|"Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question Which autoinjector do you prefer overall?"|Week 8|The primary analysis set consisted of all randomized participants who received at least 1 injection of Eetanercept with each autoinjector and indicated a preference for an autoinjector in the Subject Preference Questionnaire. N = number of participants with RA and PsO respectively.|||percentage of participants||95% Confidence Interval|Number
1344843|NCT01875978|Primary|Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease|"Ceck serum endothelial progenitor cells in the monocytes group but not in the lymphocytes group. Serum EPCs in the monocytes group provide the effect of endothelial repair to support novel vessel protection.~Cytometry flow check 150,000 cells per time including monocytes and lymphocytes group. Positive cells is the EPCs in the monocytes group. Stain with KDR, call kinase insert domain receptor, also call as VEGF receptor-2.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||positive cells/150,000 cells||Standard Error|Mean
1344844|NCT01875978|Primary|Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum Insulin-like growth factor-1 levels. Serum Insulin-like growth factor-1 (IGF-1) influence metabolic status and reduce EPCs apoptosis via IGF-1 receptor.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||ng/ml||Standard Error|Mean
1344845|NCT01875978|Primary|Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease|"Check serum anti-oxidative capacity, especially the serum superoxide dismutase (SOD) levels.Serum SOD provide the anti-oxidative capacity in lipid oxidation.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||U/mg-protein||Standard Error|Mean
1344846|NCT01875978|Primary|Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose~Check serum anti-inflammatory status: levels in C reactive protein~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||mg/dl||Standard Error|Mean
1344847|NCT01875874|Secondary|Proportion of Subjects Who Survived at the End of Study Day 28 or Who Received Orthotopic Liver Transplantation on or Before That Study Day.|A chi-square test will be used to evaluate and compare the proportion of ITT ELAD vs matched historical control subjects who survived at the End of Study Day 28 or who received orthotopic liver transplantation on or before that Study Day. In addition, the above proportion for ELAD subjects will be compared with the comparable aggregate historical control proportion from the historical control population that most closely matches the inclusion and exclusion criteria in this protocol.|Study Day 1 through Study Day 28||||Participants|||Count of Participants
1344848|NCT01875874|Primary|Overall Survival (OS) of ALF Subjects|Overall survival in subjects with acute liver failure will be summarized and compared against matched historical control subjects through Study Day 28.|Study Day 1 through Study Day 28||||Participants|||Count of Participants
1344849|NCT01875848|Secondary|Patient Global Impression of Change (PGIC)|"The Patient Global Impression of Change Scale (PGIC) is one question capturing the individual's overall perception of efficacy of treatment in a clinical trial. It uses verbal outcome categories on a 7-point scale with very much worse and very much better as anchors and no change in the middle. The verbal categories were coded on a scale with -3 very much worse,+3 very much better, and 0 same. To calculate the mean and standard deviation of each group (Bup/Opioid Increase) we took the sum of each participants final PGIC score and divided by the total number of participants."|12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.|||units on a scale||Standard Deviation|Mean
1344850|NCT01875848|Primary|Change in Numeric Rating Scale of Pain Severity|Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain level according to VHA treatment guidelines.|Baseline and 12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.|||units on a scale||Standard Deviation|Mean
1344851|NCT01875783|Secondary|Rates of Retinal Treatment Over 1 Year for Patients With DME|Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist|9 months|This is the subgroup of participants who were referred for retina care by the OCT guided referral algorithm.|||Participants|||Count of Participants
1344852|NCT01875783|Secondary|Rates of Retinal Treatment for Patients With DME|Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment|One month|This is the subgroup of participants who were referred for retinal care by the OCT guided referral algorithm|||Participants|||Count of Participants
1344853|NCT01875783|Secondary|Retinal Referral Rates for Patients With DME|Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm|Baseline visit||||eyes|eyes||Count of Units
1344854|NCT01875783|Primary|Rates of Retina Care Referral for Patients With Diabetic Macular Edema|Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm|Baseline visit||||Participants|||Count of Participants
1344855|NCT01875731|Secondary|Treatment Failure in Each Group|Number of participants with persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm. after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.|1, 2, 5, 7 and 10 days from baseline||||participants|||Number
1344856|NCT01875731|Primary|Use of Antibiotics in Each Group|Number of participants with use of any antibiotic, at any time after diagnosis|At day 7 from baseline||||participants|||Number
1344859|NCT01875445|Secondary|The Massachusetts General Hospital (MGH) Hairpulling Scale|The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the MGH Hairpulling Scale for the duration of the 10 weeks, baseline and final visits will be use for general final outcome assessment. The scale itself asses severity of hair pulling.|Once every two weeks for the 10 weeks of the study|Last observation carried forwards for general averages.|||units on a scale||Standard Deviation|Mean
1344860|NCT01875445|Primary|The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)|The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the NIMH-TSS for the duration of the 10 weeks, but only baseline and final values will be used for general final outcome assessment. The scale itself asses severity of hair pulling.|Once every two weeks for the 10 weeks of the study|Last observation carried forward for general means.|||units on a scale||Standard Deviation|Mean
1344861|NCT01875185|Secondary|Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin|Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin|change from baseline to 7 days|No data was collected for this outcome measure, as the study was terminated prematurely||||||
1344862|NCT01875185|Secondary|Level of UTXB2 in pg/mg Creatinine|Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin|baseline|Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.|||pg/mg||Inter-Quartile Range|Median
1344863|NCT01875185|Primary|The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone|Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days.|baseline to 7 days|Data was only collected at baseline. The study was terminated prior to obtaining study data.||||||
1344864|NCT01875185|Primary|Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine|Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days.|Baseline|Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.|||pg/mg||Inter-Quartile Range|Median
1344865|NCT01875159|Primary|Number of Seconds of Intermittent Hypoxia Per Hour|Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat|||seconds per hour||Standard Deviation|Mean
1344866|NCT01875159|Primary|Episodes of Intermittent Hypoxia Per Hour|Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat|||Events per hour||Standard Deviation|Mean
1344867|NCT01874951|Secondary|Remission Rate|Remission is defined as a final HAM-D-17 score of 7 or less. Remission rate is the percent of patients who attain this threshold score.|Remission rate at 3 weeks.|Study completers.|||Participants|||Count of Participants
1344868|NCT01874951|Secondary|Response Rate|Response is defined as an improvement in HAM-D-17 score of greater than or equal to 50% compared to baseline score. Response rate is the percent of patients who attain this threshold degree of improvement.|Response rate after 3 weeks|Study completers.|||Participants|||Count of Participants
1344869|NCT01874951|Secondary|Final CGI-I Score|Clinical Global Improvement-Improvement Scale. The CGI-I scale is a one item scale that measures overall change in patient’s global condition compared to when they were entered into the study. The scale is graded from 1-7, where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Thus higher scores indicate greater worsening, and lower scores indicate greater improvement. The lowest possible score (indicating maximum improvement) is 1, and the highest possible score (indicating greatest worsening) is 7.|From baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
1344870|NCT01874951|Secondary|Change in CGI-S Total Score|Clinical Global Improvement-Severity Scale. The CGI-S score is a one-item scale that measures severity of depression, scored from 1-7, where 1 = no depression is present, 2 = borderline depression, 3 = mild depression, 4 = moderate depression, 5 = marked depression, 6 = severe depression, and 7 = among the most extremely depressed patient. Thus higher scores indicate greater depressive severity. The change in CGI-S score can represent a drop from 7 (maximum severity) to 1 (no depression) or -6. There is no minimum CGI-S score required for admission, but a minimum score of 18 on the HAMD17 corresponds to approximately a score of 4 on the CGI-S. Thus a maximum worsening would be from 4 to 7, or +3.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
1344871|NCT01874951|Secondary|Change in MADRS-15 Total Score|Montgomery-Asberg Depression Rating Scale- 15 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 90 to zero, or -90. There is no minimum score on the MADRS-15 required for study entry, since the HAMD-17 was the sole entry criteria. However, a score of 18 on the HAMD17 corresponds to approximately a score of 21 on the MADRS-10. A maximum estimated increase would thus be from 21 to 90, or +69.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
1344872|NCT01874951|Secondary|Change in MADRS-10 Total Score|Montgomery-Asberg Depression Rating Scale- 10 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 60 to zero, or -60. There is no minimum score on the MADRS-10 required for study entry, since the HAMD-17 was the sole entry criteria. However, a score of 18 on the HAMD17 corresponds to approximately a score of 21 on the MADRS-10. A maximum estimated increase would thus be from 21 to 60, or +39.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
1344873|NCT01874951|Secondary|Change in HAM-D28 Total Score|Hamilton Depression Scale-28 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 81 to zero, or -81. A maximum increase would be from 18 (the minimum score required for admission) to 81, or +63.|Change from baseline to week 3|Study subjects who completed the protocol|||units on a scale||Standard Deviation|Mean
1344874|NCT01874951|Primary|Change in HAM-D-17 Total Score|Hamilton Depression Scale-17 (HAM-D-17) item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 52 to zero, or -52. A maximum increase would be from 18 (the minimum score required for admission) to 52, or +34.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
1344875|NCT01874665|Secondary|Cmax, SS: Maximum Observed Plasma Concentration at Steady State for Ponatinib||Pre-dose and at multiple timepoints (up to 1 month) post-dose|Data was not collected for Cmax,ss, since outcome measure was not planned to be analyzed.||||||
1344876|NCT01874665|Secondary|Number of Participants Reporting One or More TEAEs and Serious Adverse Event (SAE)||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
1344877|NCT01874665|Secondary|Number of Participants With TEAEs Related to Echocardiography Parameter||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
1344878|NCT01874665|Secondary|Number of Participants With TEAEs Related to Electrocardiogram (ECG) Findings||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
1344879|NCT01874665|Secondary|Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Laboratory Parameters||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
1344880|NCT01874665|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Sign Measurements||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
1344881|NCT01874665|Secondary|Number of Participants With Physical Examination||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
1344882|NCT01874665|Secondary|Overall Survival (OS)|OS is defined as the time interval between the first dose of study drug to death due to any cause. Overall survival was analyzed using the Kaplan-Meier method.|From first dose of drug until the end of the study or death, whichever came first, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||days||95% Confidence Interval|Median
1344883|NCT01874665|Secondary|Percentage of Participants With Objective Response Rate (ORR)|ORR is defined as the composite of CR and PR per Response Evaluation Criteria in RECIST 1.1, assessed for each cohort and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions.|From date of enrollment until discontinuation or the end of the study, whichever came first, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study. The ITT population where data at specified time points was available.|||percentage of participants||95% Confidence Interval|Number
1344884|NCT01874665|Secondary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever may come first. To assess PFS in each cohort and in the total participant population.|From date of enrollment until the end of the study or disease progression or death due to any cause, whichever came first, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||days||95% Confidence Interval|Median
1344885|NCT01874665|Secondary|Clinical Benefit Rate (CBR) in Cohort B|To assess clinical benefit rate in participants with GIST that lacks KIT exon 11 mutations (Cohort B) and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, PD.|16 weeks after first dose|The ITT population included all participants who received any dose of ponatinib in the study.|||percentage (%) of participants||95% Confidence Interval|Number
1344895|NCT01874353|Secondary|Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).|Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks (assessed up to a maximum of 36 months). Analyzed at the time of the primary analysis of PFS and a further analysis of OS will be performed at approximately 60% maturity.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
1344886|NCT01874665|Primary|Clinical Benefit Rate (CBR) in Cohort A|To assess clinical benefit rate in participants with KIT exon 11-mutant GIST.It is defined as the composite of complete response(CR),partial response(PR),and stable disease(SD) lasting >=16 weeks per modified Response Evaluation Criteria In Solid Tumors(RECIST) 1.1 as a measure of disease control.CR is complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.All nodes, both target and non-target, must decrease to normal (short axis <10millimeter [mm]).No new lesions.PR is >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD is not qualifying for CR,PR,Progressive Disease(PD).PD is >=20% increase from the smallest prior sum of the longest diameter(SLD)and with >=5mm absolute increase, or appearance of a new lesion.|16 weeks after first dose|The ITT population included all participants who received any dose of ponatinib in the study. The ITT population where data at specified time points was available.|||percentage (%) of participants||95% Confidence Interval|Number
1344887|NCT01874353|Secondary|To Determine the Exposure to Olaparib by Pharmacokinetic Analysis|To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy|Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose|Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1344888|NCT01874353|Secondary|Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.|To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).|Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression.|FAS consisting of all patients who are randomized and confirmed as Myriad gBRCAm|||Months||95% Confidence Interval|Median
1344889|NCT01874353|Secondary|Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT).|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to study treatment discontinuation or death (TDT).|Time elapsed from randomization to study treatment discontinuation or death. Assessed up to a maximum of 36 months. A further analysis of TDT will be performed at approximately 60% OS maturity.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
1344890|NCT01874353|Secondary|Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST).|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to second subsequent therapy or death (TSST).|Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed up to a maximum of 36 months. A further analysis of TSST will be performed at approximately 60% OS maturity.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
1344891|NCT01874353|Secondary|Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST).|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST).|Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed up to a maximum of 36 months. A further analysis of TFST will be performed at approximately 60% OS maturity.|FAS consisting of all patients who are randomised|||Months||95% Confidence Interval|Median
1344892|NCT01874353|Secondary|Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy – Ovarian (FACT-O)|To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy – Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.|Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months.|FAS consisting of all patients who are randomized with a baseline and post baseline TOI score available|||Change in TOI over 12 months||95% Confidence Interval|Least Squares Mean
1344893|NCT01874353|Secondary|Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression|Radiologic scans performed at baseline then every 12 weeks for 72 weeks, then every 24 weeks thereafter until first progression. Disease then assessed per local practice every 12 weeks until second progression. Assessed up to a maximum of 36 months.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
1344894|NCT01874353|Secondary|Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.|CA-125 performed at baseline then every 4 weeks. Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks until objective radiological disease progression. Assessed up to a maximum of 36 months.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
1347060|NCT01840605|Primary|Change From Baseline in Pruritus Score|The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|Baseline and 2 weeks||||units on a scale||Standard Error|Least Squares Mean
1344896|NCT01874353|Primary|Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)|To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.|Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 36 months.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
1344897|NCT01874340|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|6 months|The safety set consists of all subjects who received at least one dose of study medication. Subjects will be analyzed according to the treatment received.|||Participants|||Number
1344898|NCT01874340|Secondary|Change in Total Volume of T2-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Baseline, Month 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
1344899|NCT01874340|Secondary|Combined Unique Active Lesions (CUAL)|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
1344900|NCT01874340|Secondary|Annualized Relapse Rate|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|6 Months|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
1344901|NCT01874340|Primary|Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
1344902|NCT01874275|Other Pre-specified|Sleep Arousal Statistics Index at 365 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a decrease in the value between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour. Lower ASI values/numbers indicate improved sleep quality.|Baseline to 365 days||2015-03-31|03/2015||||
1344903|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant’s muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.|Baseline to 365 days||||percentage of change||Standard Deviation|Mean
1344904|NCT01874275|Secondary|Percent Change in Percent Range of Motion From Baseline to 365 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.|Baseline to 365 days||||percentage of change||Standard Deviation|Mean
1344905|NCT01874275|Other Pre-specified|Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a percent improvement between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour.|Baseline to 180 days||||percentage of change||Standard Deviation|Mean
1344906|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, and 180 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant’s muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 180 days.|Baseline to 180 days||||percentage of change||Standard Deviation|Mean
1344937|NCT01873950|Secondary|Change in Ventricular Gradient Using Exposure/Response (Ranolazine and Quinidine Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in ventricular gradient for the observed mean Cmax for each drug may be calculated."|24 hours||||mV.ns per mcg/ml||95% Confidence Interval|Mean
1344907|NCT01874275|Primary|Percent Change in Range of Motion From Baseline to 180 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90 and 180 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 180 days. Efficacy is defined as an increase in range of motion.|Baseline to 180 days||||percentage of change||Standard Deviation|Mean
1344908|NCT01874262|Primary|Non-adherence Score|The primary composite endpoint was defined as a non-adherence score based on the combination of adherence failure events and treatment gaps. Adherence failure events were defined as 2 missed doses during an observation cycle of up to 7 days. The first registered missed dose of ticagrelor in the e-diary initiated an observation cycle of 1 week. If a second missed dose was registered during the week, this was considered an adherence failure event. The third missed dose initiated a new observation cycle, and the process restarted. If the second missed dose was registered after more than 1 week, this was not defined as an adherence failure event, but initiated a new observation cycle. Treatment gaps were defined as patient reported gaps of 4 consecutive doses.|6 months||||Non-adherence score||Standard Deviation|Mean
1344909|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
1344910|NCT01874145|Primary|Injection-Related Adverse Events in the Extension Period|Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE|||events|||Number
1344911|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) – 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
1344912|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
1344913|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
1344914|NCT01874145|Secondary|Injection Site Reaction Events in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR).~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.|||events|||Number
1344915|NCT01874145|Secondary|Injection Site Reaction Event Rate Per Year in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.|||events per year|||Number
1344953|NCT01873417|Secondary|Participants' Use of Symptomatic Therapy, by Type and Category|The symptomatic therapies used by DMF-treated participants were self-reported by type and category. Each participant may have taken more than one symptomatic therapy type but was counted only once within each therapy category. Acetylsalicylic acid (ASA) is abbreviated in the table.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||participants|||Number
1344916|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) – 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
1344917|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) – 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
1344918|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing over time.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 psychological score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
1344919|NCT01874145|Primary|Injection-Related Adverse Event Rate Per Year in the Extension Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.~For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE|||events per year|||Number
1344920|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing over time.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 physical score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2, 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
1344921|NCT01874145|Secondary|Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient.~Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set|||events per year||Standard Error|Mean
1344922|NCT01874145|Other Pre-specified|Percentage of Participants With Adverse Events Other Than Injection Related Reactions During the Core Period and the Extension Period|An adverse event was defined in the protocol as any untoward medical occurrence in a patient that developed or worsened in severity during the conduct of the clinical study of a pharmaceutical product and did not necessarily have a causal relationship to the study drug. This outcome summarizes the % of participants who had AEs other than injection related reactions. Injection-related (IR) adverse events referring to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Day 1 to Month 4 (core period); Month 5 to 10 (extension period)|Safety analysis set|||percentage of participants|||Number
1344954|NCT01873417|Secondary|Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy|Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||percentage of participants|||Number
1344923|NCT01874145|Primary|Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.~For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient.~Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set|||events per year||Standard Error|Mean
1344924|NCT01874132|Other Pre-specified|Quality of Life|Measured by the Satisfaction With Life Scale.|One year|||||||
1344925|NCT01874132|Secondary|Risk of Falls|Descriptive frequency of the number of participants who took ≥12 seconds to complete the Timed Get-up and Go test, and those who took less than 12 seconds (low risk of falling).|One year||||Participants|||Count of Participants
1344926|NCT01874132|Primary|Cardiovascular Disease Risk Factors|Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.|one year|Only 48 participants completed the body composition, blood pressure and hematology assessments, and were included in analysis.|||participants|||Number
1344927|NCT01874119|Primary|Number of Patients With Complete Response During Inpatient Admission|No vomiting from the initiation of through 48 hours following the final dose of HD IL-2|From the initiation of through 48 hours following the final dose of Interleukin-2||||Participants|||Count of Participants
1344928|NCT01874054|Secondary|Progression-free Survival|The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.|Up to 3 years|All patients who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.|||months||95% Confidence Interval|Median
1344929|NCT01874054|Secondary|Duration of Response|The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.|Up to 3 years|Patients with a complete or partial response who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 2 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.|||months||95% Confidence Interval|Mean
1344930|NCT01874054|Secondary|Overall Best Response Rate|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma|Every 3 months for up to 3 years|All patients who received at least 2 cycles of combination treatment, had a baseline tumor assessment, and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) any time after the first dose of combination therapy.|||Participants|||Count of Participants
1344931|NCT01874054|Secondary|Incidence of Dose-limiting Toxicities|Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.|Up to 3 weeks; the first cycle of therapy through the first day of Cycle 2.|All patients who enrolled and received at least 1 dose of brentuximab vedotin.|||Participants|||Count of Participants
1344932|NCT01874054|Primary|Incidence of Adverse Events|All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.|Up to 16 cycles plus 30 days; approximately 12 months|All subjects who were enrolled and received at least 1 dose of brentuximab vedotin.|||Participants|||Count of Participants
1344933|NCT01874054|Primary|Complete Remission Rate|Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.|Up to 16 cycles plus 30 days; approximately 12 months|All patients who received at least 2 cycles of combination treatment at the recommended dose level and had a baseline tumor assessment and at least 1 postbaseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy at the recommended dose level.|||percentage of participants||95% Confidence Interval|Number
1344934|NCT01873989|Primary|Change in Sexual Dysfunction From Baseline to Week 8|Decreased sexual dysfunction will be assessed using the Erectile Function (EF) subscale of the International Index of Erectile Function (IIEF). The EF subscale has 6 items scored on a zero to five Likert-type scale. Change in sexual dysfunction was calculated by subtracting the mean EF subscale score at week 8 from the mean EF subscale score at baseline. The range of the EF subscale is 0-30 (with higher scores representing greater functioning). The Cut-offs for the EF subscales are as follows: no erectile dysfunction (score 26–30), mild erectile dysfunction (22–25), mild to moderate erectile dysfunction(17–21), moderate erectile dysfunction (11–16), and severe erectile dysfunction (0–10).|8 weeks||||units on a scale||Standard Deviation|Mean
1344935|NCT01873989|Primary|Change in Pain Ratings|Pain ratings will be assessed by self-report (4 items from Brief Pain Inventory). Change in pain ratings was assessed by examining the differences between pain ratings at baseline and week 8. Higher values are considered to be a worse outcome. The scale range is 0-10.|8 weeks||||units on a scale||95% Confidence Interval|Mean
1344936|NCT01873989|Primary|Number of Participants Demonstrating Abstinence|Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.|8 weeks||||Participants|||Count of Participants
1344938|NCT01873950|Secondary|Change in Ventricular Gradient Using Exposure/Response (Dofetilide and Verapamil Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in ventricular gradient for the observed mean Cmax for each drug may be calculated."|24 hours||||mV.ns per ng/ml||95% Confidence Interval|Mean
1344939|NCT01873950|Secondary|Change in Spatial QRS-T Angle Using Exposure/Response (Ranolazine and Quinidine Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in spatial QRS-T angle for the observed mean Cmax for each drug may be calculated."|24 hours||||degrees per mcg/ml||95% Confidence Interval|Mean
1344940|NCT01873950|Secondary|Change in Spatial QRS-T Angle Using Exposure/Response (Dofetilide and Verapamil Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in spatial QRS-T angle for the observed mean Cmax for each drug may be calculated."|24 hours||||degrees per ng/ml||95% Confidence Interval|Mean
1344941|NCT01873950|Secondary|Change in PR, QRS, J-Tpeak, Tpeak-Tend and QTc Using Exposure/Response (Ranolazine and Quinidine Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in QTc for the observed mean Cmax for each drug may be calculated."|24 hours||||ms per mcg/ml||95% Confidence Interval|Mean
1344942|NCT01873950|Secondary|Change in PR, QRS, J-Tpeak, Tpeak-Tend and QTc Using Exposure/Response (Dofetilide and Verapamil Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in QTc for the observed mean Cmax for each drug may be calculated."|24 hours||||ms per ng/ml||95% Confidence Interval|Mean
1344943|NCT01873950|Secondary|Change in Relationship (Ratio) Between Heart Rate and QT|Different post-dose time-points employ different techniques for altering heart rate (leg raises and postural maneuvers). Using the measurements from all the time-points of postural maneuvers, the QT/RR relationship was modeled as a linear relationship between the square root of RR in seconds and QT in seconds and computed on a by subject, treatment and time-point basis. The change in the QT and heart rate relationship was assessed as the difference (mean and 95% CI) between the slopes from the models for each drug vs. placebo.|24 hours||||ratio||95% Confidence Interval|Mean
1344944|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Ventricular Gradient|Compute maximum mean placebo, and baseline-adjusted change for: ventricular gradient (mV*ms).|24 hours||||mV*ms||95% Confidence Interval|Least Squares Mean
1344945|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Spatial QRS-T Angle|Compute maximum mean placebo, and baseline-adjusted change for: spatial QRS-T angle (degrees)|24 hours||||degrees||95% Confidence Interval|Least Squares Mean
1344946|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in PR, QRS, J-Tpeak, Tpeak-Tend and QTc|Compute maximum mean placebo, and baseline-adjusted change for: PR (ms), QRS (ms), J-Tpeak (ms), Tpeak-Tend (ms) and QTc (ms)|24 hours||||ms||95% Confidence Interval|Least Squares Mean
1344947|NCT01873859|Primary|Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.||48 hours from the baseline||||mg/dl||Standard Deviation|Mean
1344948|NCT01873859|Primary|Incidence of Lactic Acidosis|Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.|48 hrs||||participants|||Number
1344949|NCT01873729|Secondary|Clinical Global Impression (CGI)|The Clinical Global Impression (CGI) scale allows the clinician to rate the severity of illness, change over time, and efficacy of medication, taking into account the patient’s clinical condition and the severity of side effects. The CGI subscales include the Clinical Global Severity of ADHD (CGI-S) which is scored on a 7 point scale (1=not ill, 7=extremely ill) and the Clinical Global Improvement of ADHD (CGI-I) which is also scored on a 7 point scale (1=very much improved, 7=very much worse). The number of subjects with CGI-Improvement scores less than or equal to 2 (very much improved) at the end of the study is reported.|Six weeks||||Participant|||Number
1344950|NCT01873729|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline|The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms).|Baseline and Six weeks||||Units on a scale||Standard Deviation|Mean
1344951|NCT01873417|Secondary|Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy|The last symptomatic therapy prior to last dose of study medication was used to summarize the number of participants who discontinued DMF due to GI-related events. Participants may have taken more than one symptomatic therapy but are counted only once in the 'All Therapies' category.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||participants|||Number
1344952|NCT01873417|Secondary|Summary of Use and Days on Symptomatic Therapy, by Category|The total duration (in days) of use of each symptomatic therapy by participants as a result of GI symptoms experienced by DMF-treated participants is presented. If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in the 'All Therapies' category.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]). n= number of participants using the therapy specified.|||days||Standard Deviation|Mean
1347635|NCT01833481|Primary|Kinematics - Swing Phase Separation|Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.|6 months post-operatively||||mm||Standard Deviation|Mean
1344955|NCT01873417|Primary|Duration of GI-related Episodes in DMF-treated Participants|In participants who took symptomatic therapy, the median duration of acute GI episodes (in hours) was summarized for the overall treatment period, by symptom (nausea, diarrhea, lower abdominal pain, upper abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence). Table only includes the symptom duration for those symptoms with start and stop times entered in the eDiary (evaluable GI episodes), based on the MAGISS.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]); n=number of participants with evaluable GI symptom specified.|||hours||Full Range|Median
1344956|NCT01873417|Primary|Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy|Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||percentage of participants|||Number
1344957|NCT01873417|Primary|Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale|Severity of GI-related events in DMF-treated participants using the MAGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).|||units on a scale||Standard Deviation|Mean
1344958|NCT01873417|Primary|Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)|Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).|||units on a scale||Standard Deviation|Mean
1344959|NCT01872910|Secondary|Part A: Patient Global Impression of Improvement (PGI-I) Scale Score|PGI-I is a participant-rated instrument that measures the improvement of the participants symptoms on a 7-point scale: 1 (very much improved), 4 (no change), and 7 (very much worse). LS mean was calculated using Mixed Effect Model Repeated Measures (MMRM) adjusted for treatment, time, the interaction of treatment and time and baseline pain VAS and fixed effects.|2, 4, 8, 12 and 24 h post-dose|Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose PGI-I assessment. Participants who received rescue medication were not included in the specific timepoints post administration of rescue medication.|||units on a scale||95% Confidence Interval|Least Squares Mean
1344960|NCT01872910|Secondary|Part A: Time to Onset of Meaningful Pain Relief|Time to onset of meaningful pain relief is defined as the time from study drug administration to the measured onset of meaningful pain relief in hours as reported by the participant. Participants who received rescue mediation prior to meaningful pain relief were censored at the time the rescue medication was received.|Study drug administration to meaningful pain relief (0 to 24 h post-dose)|FAS: Part A participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A LY3023703=24, Celecoxib=2, Placebo=15.|||h||95% Confidence Interval|Median
1344961|NCT01872910|Secondary|Part A: Time to Onset of First Perceptible Pain Relief|Time to onset of the first perceptible pain relief is defined as the time from study drug administration to the measured onset of first perceptible pain relief in hours as reported by the participant. Participants who received rescue mediation prior to first perceptible pain relief were censored at the time the rescue medication was received.|Study drug administration to first perceptible pain relief (0 to 24 h post-dose)|FAS: Part A participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=11, Celecoxib=2, Placebo=9.|||h||95% Confidence Interval|Median
1344962|NCT01872910|Secondary|Time to First Use of Rescue Medication|"Time to first use of rescue medication is defined as the time from study drug administration to the measured first use of rescue medication in hours. Participants were censored at 24 h post-dose if no rescue medication was administered.~Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol."|Study drug administration to first use of rescue medication (0 to 24 h post-dose)|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=5, Celecoxib=18, Placebo=12, Part B: LY3023703=0, Placebo=2.|||h||95% Confidence Interval|Median
1344963|NCT01872910|Secondary|Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale|"The summed (time-weighted) pain intensity difference to baseline (SPID) at 4, 6, 8, 12, and 24 h post-dosing, as measured by a participant-rated 4-point categorical scale of 0 (no pain) to 3 (severe pain) and was calculated as: the area under the change in pain intensity versus time curve. Total scores range: -24 (best) to 8 (worst) for SPID 0 to 8 h. Score ranges for SPID(0-4h), SPID(0-6), SPID(0-12) and SPID(0-24) are -12 to 4, -18 to 6, -36 to 12 and -72 to 24 respectively. Participants were required to have moderate (score=2) or severe (score=3) pain at baseline in order to be eligible for randomization.LS mean were calculated using ANCOVA and was adjusted for treatment as a fixed effect and baseline pain intensity as a continuous covariate. The measure of dispersion reported is 95% CrI not CI. A negative direction indicated a pain reduction from baseline.~There were no planned efficacy analysis for Pre-Part B per protocol."|0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy.|||units on a scale||95% Confidence Interval|Least Squares Mean
1344974|NCT01872689|Secondary|Minimum Observed Serum Concentration (Cmin) of Lebrikizumab|Participants who received lebrikizumab were only included in the analysis.|Predose (Hour 0) at Weeks 4, 12, 24, and 36|Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and ‘Number Analyzed’ signifies number of participants evaluable at specified time points.|||mcg/mL||Standard Deviation|Mean
1349018|NCT01811680|Primary|6 Minute Walk Test (Metres)|6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8)|8 weeks|chronic stroke|||metres||Standard Deviation|Mean
1344964|NCT01872910|Secondary|Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS|"Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of post oral surgery pain. Weighted mean change from baseline was calculated as: [area under the change in pain intensity versus time curve] / [time period that is (i.e.) 24 h for 0 to 24 h endpoint]. The baseline pain intensity was the pain assessment prior to dosing of study medication. LS mean were calculated using ANCOVA adjusted for treatment, time and interaction of treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is the 95% CrI not CI. A negative direction indicated a pain reduction from baseline.~Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol."|Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy.|||mm||95% Confidence Interval|Least Squares Mean
1344965|NCT01872910|Secondary|Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose|"TOPAR was calculated as the area under the pain relief versus time curve of the participant reported pain relief scores from the 5-point pain relief scale of 0 (no pain relief) to 4 (complete pain relief). LS mean were calculated using ANCOVA adjusted for treatment as a fixed effect. The measure of dispersion reported is CrI not CI. A negative direction indicated a pain relief from baseline.~Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol."|0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy excluding Pre-Part B.|||pain relief * h||95% Confidence Interval|Least Squares Mean
1344966|NCT01872910|Primary|Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS|Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: [the area under the change in pain intensity versus time curve] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline.|0 to 8 h post-dose|Full Analysis Set (FAS): Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 postdose efficacy assessment. Pain assessments after rescue medication were imputed using last observation carried forward (LOCF) from the pain assessment prior to rescue therapy.|||mm||95% Confidence Interval|Least Squares Mean
1344967|NCT01872819|Secondary|Rate of Complete Response, Defined by Criteria of Cheson et al.|"Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction).~Cheson et al. defines a CR as: Bone Marrow blasts <5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 10^9/L, and platelet count >100 x 10^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (<1.0 x 10^9/L) or thrombocytopenia (<100 x 10^9/L)."|Baseline up to 2 years|14 patients received therapy. Out of 14 patients treated, 9 were evaluable (4 patients died prior to D14-21 marrow and 1 patient refused the D14-21 marrow).|||Patients|||Number
1344968|NCT01872819|Primary|Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML|Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results.|Up to 21 days|14 patients were treated.|||days||Full Range|Median
1344969|NCT01872715|Secondary|Patient Satisfaction Question|The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.|Week 2, 6, and 12||||participants|||Number
1344970|NCT01872715|Secondary|Patient Global Assessment (PGA) of Rosacea Scores|Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules|Baseline, Weeks 2, 6, and 12||||participants|||Number
1344971|NCT01872715|Secondary|Rosacea-Specific Quality of Life Index|ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.|||units on a scale||Standard Deviation|Mean
1344972|NCT01872715|Primary|Rosacea Score on the Visual Analog Scale|VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.|||units on a scale||Standard Deviation|Mean
1344973|NCT01872689|Secondary|Elimination Half-Life (t1/2) of Lebrikizumab|Elimination half-life is the time measured for the plasma drug concentration to decrease by one-half during the elimination phase of the drug. Analysis was performed on PK-Evaluable Population. Participants who received lebrikizumab were only included in the analysis.|Pre-dose (Hour 0) at Weeks 1, 4, 12, 24, 36, 64, 76, 88, 104; and at 4, 12, and 18 weeks post-last dose (last dose = Week 104)|Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
1344975|NCT01872689|Secondary|Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52|Participants who received lebrikizumab were only included in the analysis.|Predose (Hour 0) at Week 52|Analysis was performed on Pharmacokinetic (PK)-Evaluable Population, which included all participants who received at least one dose of study drug and had at least one non-missing PK observation. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1344976|NCT01872689|Secondary|Percentage of Participants With Anti-therapeutic Antibody (ATA) to Lebrikizumab|ATA to lebrikizumab was tested using a validated immunoassay. A positive ATA result was defined as one in which the presence of detectable ATAs could be confirmed by competitive binding with lebrikizumab. Percentage of participants with positive results for ATA at Baseline and at post-baseline time points were reported. Only participants who received lebrikizumab were included in the analysis.|Baseline and Post-Baseline (assessed at multiple time points: Weeks 4, 12, 24, 36, 52, 56, 64, 76, and at safety follow-up up to Week 122)|Analysis was performed on Safety Population (all participants who received at least one dose of study drug grouped according to the actual treatment received). 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure; ‘Number Analyzed’ = number of participants evaluable at indicated time points.|||percentage of participants|||Number
1344977|NCT01872689|Secondary|Time to First Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause|DLco is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100. Time from randomization to first occurrence of >/=15% absolute decrease in percentage of predicted DLco or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
1344978|NCT01872689|Secondary|Percentage of Participants With an Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause|DLco (in mL/min/mmHg) is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100.|Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1344979|NCT01872689|Secondary|Time to Respiratory-Related Hospitalization|Time from randomization to first occurrence of an event of respiratory-related hospitalization was reported. Participants without an event were censored at the last known alive day, study Day 368, or the last date during the double-blind period. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of respiratory-related hospitalization (up to Week 122)|Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
1344980|NCT01872689|Secondary|Percentage of Participants With Respiratory-Related Hospitalization||Baseline up to the event of respiratory-related hospitalization (up to Week 122)|Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1344981|NCT01872689|Secondary|Time to First Event of Acute IPF Exacerbation|Time from randomization to first occurrence of an event of IPF exacerbation was reported. IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, or other events leading to acute lung injury. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of acute IPF exacerbation (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
1344982|NCT01872689|Secondary|Percentage of Participants With an Event of Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, such as left heart failure, pulmonary embolism, pulmonary infection (on the basis of endotracheal aspirate or bronchoalveolar lavage if available, or investigator judgment), or other events leading to acute lung injury (for example, sepsis, aspiration, trauma, reperfusion pulmonary edema).|Baseline up to the event of acute IPF exacerbation (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1344983|NCT01872689|Secondary|Time to First Occurrence of SGRQ Total Score Worsening or Death From Any Cause|The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Time from randomization to first occurrence of an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
1344984|NCT01872689|Secondary|Percentage of Participants With an Event of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening or Death From Any Cause|The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Percentage of participants with an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported.|Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1344985|NCT01872689|Secondary|Annualized Rate of Decrease in A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Total Score Over 52 Weeks|The ATAQ-IPF Version 3 was utilized that included 31 items within 5 domains: cough (6 items), dyspnea (7 items), exhaustion (6 items), emotional well-being (6 items), and independence (6 items). Each item was assessed on a scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). The ATAQ-IPF had a recall specification of 2 weeks. Simple summation scoring was used to derive individual domain scores as well as a total score. ATAQ-IPF total score ranged from 31 to 124 with lower score indicating better quality of life (QoL). Annualized rates of decrease (slope throughout time from baseline to Week 52) in ATAQ-IPF questionnaire total score was assessed and reported.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||units on a scale/year||Standard Error|Mean
1344986|NCT01872689|Secondary|Annualized Rate of Decrease in FVC Over 52 Weeks|Annualized rates of decrease (slope throughout time from baseline to Week 52) in FVC (in milliliters per year [mL/year]) was assessed and reported. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||mL/year||Standard Error|Mean
1344987|NCT01872689|Secondary|Progression-Free Survival (PFS)|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC = [(observed FVC)/(predicted FVC)]*100. PFS was defined as time from randomization to death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median PFS was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
1344988|NCT01872689|Secondary|Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC = [(observed FVC)/(predicted FVC)]*100.|Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1344989|NCT01872689|Secondary|Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks|Annualized rates of decrease (slope throughout time from baseline to Week 52) in DLco was assessed and reported. DLco (in milliliters per minute/millimeters of mercury [mL/min/mmHg]) is a measure of the gas transfer.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||mL/min/mmHg/year||Standard Error|Mean
1344990|NCT01872689|Secondary|Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100. Time from randomization to first occurrence of an event of >/=10% absolute decline in percent predicted FVC or death from any cause was reported. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median time to event was estimated using Kaplan-Meier method. 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
1344991|NCT01872689|Secondary|Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.|Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1350232|NCT01793935|Secondary|Immune Marker IL-4|Changes in immune marker IL-4 will be assessed in response to study medication.|Baseline and12 weeks or end of study|Data cannot be summarized- IL-4 levels undetectable|||pg/mL||Standard Deviation|Mean
1344992|NCT01872689|Secondary|Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks|Annualized rates of decline (slope throughout time from baseline to Week 52) in 6MWT was assessed and reported. 6MWT was the distance (in meters [m]) that a participant could walk in 6 minutes.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||m/year||Standard Error|Mean
1344993|NCT01872689|Primary|Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks|Annualized rates of decrease (slope throughout time from baseline to Week 52) for percent predicted FVC was assessed and reported. FVC is a standard pulmonary function test. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||percent predicted FVC/year||Standard Error|Mean
1344994|NCT01872611|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
1344995|NCT01872611|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
1344996|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set|||Percentage of participants|||Number
1344997|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set|||Percentage of participants|||Number
1344998|NCT01872611|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set|||Percentage of participants|||Number
1344999|NCT01872611|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set|||Percentage of participants|||Number
1345000|NCT01872078|Primary|Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7|Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7|Day 7||||Ratio||95% Confidence Interval|Geometric Mean
1345001|NCT01871870|Secondary|Deviation From Target Blood Glucose|Assessment of how accurately the algorithm controls glycemia in the subjects will be carried out using the mean deviation from the target blood glucose (mg/dL). Deviation is measured as algorithm controlled glucose level minus target glucose level.|28 hours||||mg/dl||Standard Deviation|Mean
1345002|NCT01871870|Primary|Verification of the Automation and Telemetry Components|This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.|28 hours||||failures||Standard Deviation|Mean
1345003|NCT01871805|Secondary|Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II|EORTC QLQ-LC13 consisted of 13 questions for dyspnea (3 items) and 10 single items (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain). Questions used 4-point scale (1 'Not at all' to 4 'Very much'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below represents absolute data at baseline.|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1345004|NCT01871805|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II|EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 ‘Not at all’ to 4 ‘Very much’; 2 questions used 7-point scale [1 ‘very poor’ to 7 ‘Excellent’]). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below (e.g. Global health status/QoL [quality of life]) represents absolute data at baseline. QoL=quality of life|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1345005|NCT01871805|Secondary|Ctrough After Multiple Dose of Alectinib: Phase II||Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 (1 cycle = 21 days)|Phase II PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.|||ng/mL||Standard Deviation|Mean
1348009|NCT01829464|Secondary|Percentage of Participants With HbA1c <7%||Week 24|Due to the relatively limited enrollment and follow-up at the time of study termination, the analysis of percentage of participants with HbA1c <7% at Week 24 was not performed.||||||
1345007|NCT01871805|Secondary|Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I|AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)|Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
1345008|NCT01871805|Secondary|Cmax After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)|Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1345009|NCT01871805|Secondary|Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)|Phase I pharmacokinetic (PK) evaluable population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1345010|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RANO Criteria by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RANO criteria. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease).|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Data were not estimable due to low number of responders and longer observation time.||||||
1345011|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST v1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1345012|NCT01871805|Secondary|CDOR According to RANO Criteria by IRC: Phase II|CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 17. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1345013|NCT01871805|Secondary|CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II|CDOR was defined for CNS responders as the time from the first observation of a CNS response of CR or PR until first observation of CNS progression or death from any cause. An analysis by IRC using RECIST v1.1 was performed. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1345014|NCT01871805|Secondary|Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II|CORR was defined as the percentage of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants with measurable CNS lesions at baseline according to RANO criteria by IRC.|||percentage of participants||95% Confidence Interval|Number
1345023|NCT01871805|Secondary|Percentage of Participants With Disease Progression According to RECIST v1.1 by IRC or Death : Phase II|Percentage of participants with disease progression according to RECIST v1.1 by IRC is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population|||percentage of participants|||Number
1345015|NCT01871805|Secondary|Percentage of Participants With Central Nervous System Objective Response (COR) According to RECIST v1.1 by IRC: Phase II|COR rate (CORR) was defined as the percentage of participants who had a CR or PR of the baseline central nervous system (CNS) lesions, based on RECIST v.1.1. CNS responses according to RECIST v1.1 did not have to be confirmed. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). 95% CI was computed using the Clopper-Pearson method.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants with measurable CNS lesions at baseline based on RECIST v1.1 according to IRC.|||percentage of participants||95% Confidence Interval|Number
1345016|NCT01871805|Secondary|DOR According to RECIST v1.1 by Investigator: Phase II|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1345017|NCT01871805|Secondary|DOR According to RECIST v1.1 by IRC: Phase II|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1345018|NCT01871805|Secondary|Overall Survival (OS) Time: Phase II|OS was defined as the time between date of first dose and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants without any follow-up information were censored at the date of first dose. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Baseline up to death (any cause) (maximum follow up 284 weeks)|Phase II safety population|||months||95% Confidence Interval|Median
1345019|NCT01871805|Secondary|Percentage of Participants Who Died Due to Any Cause: Phase II||Baseline up to death (any cause) (maximum follow up 284 weeks)|Phase II safety population|||percentage of participants|||Number
1345020|NCT01871805|Secondary|PFS According to RECIST v1.1 by Investigator: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population|||months||95% Confidence Interval|Median
1345021|NCT01871805|Secondary|Percentage of Participants With Disease Progression According to RECIST v1.1 by Investigator or Death : Phase II|Percentage of participants with disease progression according to RECIST v1.1 by investigator is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population|||percentage of participants|||Number
1345022|NCT01871805|Secondary|Progression-Free Survival (PFS) According to RECIST v1.1 by IRC: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population|||months||95% Confidence Interval|Median
1345147|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - T1/2|Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
1345024|NCT01871805|Secondary|Percentage of Participants With Disease Control According to RECIST v1.1 by Investigator: Phase II|Disease control rate assessed according to RECIST v1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. 95% CI for rate was constructed using Clopper-Pearson method.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population|||percentage of participants||95% Confidence Interval|Number
1345025|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II|Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population|||percentage of participants||95% Confidence Interval|Number
1345026|NCT01871805|Secondary|Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I|DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer “Outcome Measure 2” for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase I RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1345027|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I|Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase I RE population comprised all Phase I participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
1345028|NCT01871805|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II|Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).|Cycle 1 Day 1 up to 194 weeks (assessed at every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter) (1 cycle = 21 days)|Phase II Response evaluable (RE) population comprised all Phase II participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
1345029|NCT01871805|Primary|Recommended Phase II Dose (RP2D): Phase I|RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.|Throughout Cycle 1 of Phase I (21 days)|Phase I safety population|||mg|||Number
1345050|NCT01871532|Secondary|Percentage of Cycles With Multifollicular Development|The multifollicular development was defined as the number of cycles with multifollicular development of three or more follicles greater than or equal to 14 millimeter|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345051|NCT01871532|Secondary|Percentage of Cycles With Bifollicular Development|The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 millimeter.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345030|NCT01871805|Primary|Number of Participants With Dose Limiting Toxicities (DLTs): Phase I|The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of >=7 days which the Investigator could not rule out as been related to alectinib.|Throughout Cycle 1 of Phase I (21 days)|Phase I safety population|||participants|||Number
1345031|NCT01871558|Secondary|Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline)|HbA1c <= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain|week 24|ITT population|||percent of participants|||Number
1345032|NCT01871558|Secondary|Percentage of Patients With Severe and Confirmed Hypoglycemic Events|Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) < 70 mg/dL|24 weeks|ITT population|||percent participants|||Number
1345033|NCT01871558|Secondary|Mean Daily Insulin Dose at Week 24||Week 24|ITT population|||(U/d)||Standard Deviation|Mean
1345034|NCT01871558|Secondary|Change From Baseline in Body Weight in Both Treatment Arms||Baseline, Week 24|Safety Population|||kg||Standard Deviation|Mean
1345035|NCT01871558|Secondary|Change From Baseline in HbA1c to Week 24 in Both Treatment Arms||Baseline, Week 24|ITT population|||HbA1c percent||Standard Deviation|Mean
1345036|NCT01871558|Secondary|Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events|Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%|24 weeks|ITT population|||percent of participants|||Number
1345037|NCT01871558|Primary|Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms||24 weeks|safety population|||percent of participants|||Number
1345038|NCT01871532|Secondary|Sex Hormone Binding Globulin (SHBG) Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345039|NCT01871532|Secondary|Testosterone Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345040|NCT01871532|Secondary|Change From Baseline in Anti-Mullerian Hormone (AMH) Levels at Week 4||Baseline, Week 4|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345041|NCT01871532|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered Per Cycle||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345042|NCT01871532|Secondary|Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345043|NCT01871532|Secondary|Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS was defined as an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations, classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications.|up to 42 days post hCG administration|Safety population included all subjects who were randomised and received at least 1 Gonal-f injection.|||subjects|||Number
1345044|NCT01871532|Secondary|Number of Miscarriages After Confirmation of Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, and clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or confirmed by clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345045|NCT01871532|Secondary|Number of Fetuses||35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345046|NCT01871532|Secondary|Number of Multiple Pregnancy|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345047|NCT01871532|Secondary|Percentage of Cycles Resulting in Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345048|NCT01871532|Secondary|Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345049|NCT01871532|Secondary|Percentage of Ovulatory Cycles|Ovulation was defined as a serum progesterone (P4 ) level greater than or equal to 10 nanogram per milliliter (ng/mL) or Clinical Pregnancy. Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345052|NCT01871532|Primary|Percentage of Cycles With Monofollicular Development|The monofollicular development was defined as the number of cycles with monofollicular development only one Follicle Greater Than or Equal (>= to 17 millimeter (mm) and no other follicles Greater than or equal to 14 mm following up to 4 weeks Gonal-f treatment.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
1345053|NCT01871519|Secondary|Neurological Success Rate|Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.|Pre-discharge, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
1345054|NCT01871519|Secondary|Subsequent Radiographic Fractures|A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.|3 months and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
1345055|NCT01871519|Secondary|Local Cobb Angle|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in LCA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||degrees|Treated levels|Standard Deviation|Mean
1345056|NCT01871519|Secondary|Vertebral Body Angle|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in VBA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||degrees|Treated levels|Standard Deviation|Mean
1345057|NCT01871519|Secondary|Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)|AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of pre-fracture height|Treated levels|Standard Deviation|Mean
1345058|NCT01871519|Secondary|Karnofsky Performance Scale|For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.|Baseline, 30 days, 3 months 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345059|NCT01871519|Secondary|Barthel Index (Only for Subjects With Osteoporosis)|For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).|Baseline, 30 days, 3 months 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345060|NCT01871519|Secondary|Ambulatory Status||Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
1345061|NCT01871519|Secondary|The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;||Baseline, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||days||Standard Deviation|Mean
1345062|NCT01871519|Secondary|Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks||Baseline, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
1345063|NCT01871519|Secondary|Quality of Life by EQ-5D Index Score||Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345064|NCT01871519|Secondary|Quality of Life by SF-36v2 PCS|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345065|NCT01871519|Secondary|Back Function (ODI)|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345066|NCT01871519|Secondary|Back Pain|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345067|NCT01871519|Primary|Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345068|NCT01871519|Primary|SF-36v2 Physical Component Summary Change From Baseline at 3 Months|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345069|NCT01871519|Primary|Back Function Change From Baseline by Oswestry Disability Index at 3 Months|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345070|NCT01871519|Primary|Back Pain Change From Baseline at 3 Months|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
1345071|NCT01871441|Secondary|The Rates of Grade III-IV GVHD in Female Recipients With Male Donors Will be Computed With Corresponding Exact Binomial 95% Confidence Intervals.|The difference in DFS in recipient-donor combinations in which there is at least 1 KIR ligand mismatch versus those without a KIR ligand mismatch will be tested using log-rank test.|Up to 1 year|No data were collected or analyzed.||||||
1345072|NCT01871441|Secondary|Rate of Grade III-IV GVHD in Female Recipients With Male Donors|The rates of grade III-IV GVHD in female recipients with male donors will be computed with corresponding exact binomial 95% confidence intervals.|Up to 1 year|No data were collected or analyzed.||||||
1345073|NCT01871441|Secondary|Number of Participants With Relapse of Disease|Relapse of Disease is defined as the return of a disease or the signs and symptoms of a disease after a period of improvement. Relapse is almost always associated with the immunological failure of the donor immune system to recognize and/or respond to reemergence of a tumor. The number of participants with relapse of disease will be collected.|Up to 1 year||||Participants|||Count of Participants
1345074|NCT01871441|Primary|Number of Participants With Disease-free Survival (DFS)|Disease free survival (DFS), defined as the time to death, relapse or disease progression.|1 year||||Participants|||Count of Participants
1345075|NCT01871402|Other Pre-specified|Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject’s palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Baseline, Day 8 and Day 15|Analysis shown is based on the ITT population at Days 8 and 15 and compared to baseline. Number of Participants Analyzed is at Day 15; at Day 8, N=109 (Active) and N=110 (Vehicle). Only participants with observed values are reported.|||Change in %BSA||Standard Deviation|Mean
1345076|NCT01871402|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject’s pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||units on a scale||Standard Deviation|Mean
1345077|NCT01871402|Other Pre-specified|Proportion of Subjects Rated a “Treatment Success” for Each of the Clinical Signs of Psoriasis at Day 8|"Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). Treatment success and clinical signs as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||percentage of participants|||Number
1345078|NCT01871402|Other Pre-specified|Proportion of Subjects With IGA “Treatment Success” at Day 8|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||percentage of participants|||Number
1345079|NCT01871402|Secondary|"Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or “average” degree of severity of each of three key characteristics present within all of the subject’s psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the ITT population.|||percentage of participants|||Number
1345080|NCT01871402|Primary|"Proportion of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
1345081|NCT01871285|Primary|Change From Baseline in Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.|||score||Standard Deviation|Mean
1345082|NCT01871285|Primary|Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 periods); 4 subjects were excluded.|||score||Standard Deviation|Mean
1345083|NCT01871285|Secondary|Change From Baseline in “Pain Now” Over Time Using NRS|Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine.|Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects excluded.|||units on a scale||Standard Deviation|Mean
1345084|NCT01871285|Secondary|Change From Baseline in COWS Total Score Over Time|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.|||score||Standard Deviation|Mean
1345085|NCT01871285|Primary|Number of Responders|A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects were excluded.|||participants|||Number
1345086|NCT01871142|Secondary|Secondary Objective Safety and Tolerability|To assess the safety and tolerability of single, escalating oral doses of Aes-103 compared with placebo in healthy adult men at rest and during stationary cycle ergometer exercise in normoxia and hypoxia by monitoring adverse events (AEs), electrocardiograms (ECGs), blood pressure, blood oxygen saturation.|AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.||||participants|||Number
1345087|NCT01871142|Primary|Primary Objective Endurance Exercise Performance|To quantify endurance exercise performance (time trial performance during stationary cycle ergometer exercise) in healthy adult men in four conditions: normoxia (normal oxygen; fraction of inspired oxygen = 0.21) following oral placebo consumption, hypoxia (low oxygen; fraction of inspired oxygen = 0.15) following oral placebo consumption, hypoxia following oral consumption Aes-103 (1000 mg) and hypoxia following oral consumption Aes-103 (3000 mg).|The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.||||minutes||Standard Error|Mean
1345088|NCT01871090|Other Pre-specified|Length of Emergency Department Stay|Defined as the time from the Emergency Department Check In Time until the Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission||||Minutes||Full Range|Median
1346507|NCT01848145|Secondary|Progression Free Survival|Defined as the time from first treatment until objective tumor progression or death from any cause.|For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.|All patients who received at least 1 dose of protocol treatment.|||months||95% Confidence Interval|Median
1345091|NCT01870999|Secondary|"Number of Participants Hospitalized for Adverse Event Worsening Schizophrenia"|The number of participants hospitalized for the Adverse Event “Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms.|7 Months|All randomized participants were included in the analysis population.|||Participants|||Number
1345092|NCT01870999|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available at the given time-point were included in this analysis population.|||units on a scale||Standard Deviation|Mean
1345093|NCT01870999|Secondary|Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).|||units on a scale||Standard Deviation|Mean
1345094|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24|The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).|||units on a scale||Standard Deviation|Mean
1345095|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24|The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).|||units on a scale||Standard Deviation|Mean
1345096|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population-last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1345097|NCT01870999|Secondary|Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||Day||Full Range|Median
1345098|NCT01870999|Secondary|Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||μg*h/mL||Standard Deviation|Mean
1345099|NCT01870999|Secondary|Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||ng/mL||Standard Deviation|Mean
1345100|NCT01870999|Secondary|Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||ng/mL||Standard Deviation|Mean
1350233|NCT01793935|Secondary|Immune Marker IL-2|Changes in immune marker IL-2 will be assessed in response to study medication.|Baseline and 12 weeks or end of study|IL-2 levels undetectable.|||pg/mL||Standard Deviation|Mean
1345101|NCT01870999|Secondary|Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. The analysis population for this outcome measure represents a sub-set who were evaluable for this measure at month 5.|||Day||Standard Deviation|Mean
1345102|NCT01870999|Secondary|Aripiprazole Steady-state Plasma Concentration (Css,Avg)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.|||ng/mL||Standard Deviation|Mean
1345103|NCT01870999|Secondary|Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.|||Day||Full Range|Median
1345104|NCT01870999|Primary|Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.|||μg*h/mL||Standard Deviation|Mean
1345105|NCT01870999|Primary|Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.|672 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 200 mg Aripiprazole IM Depot arm.|||ng/mL||Standard Deviation|Mean
1345106|NCT01870999|Primary|Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.|||ng/mL||Standard Deviation|Mean
1345107|NCT01870999|Primary|Number of Participants With Adverse Events as a Measure of Safety|Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.|7 Months|Participants who received at least one dose of study medication are included in the safety analysis set.|||Participants|||Number
1345108|NCT01870973|Primary|Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use|"pain measurement as assessed on a visual analog scale and pain medication usage~definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression~VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success."|each day for 5 days||||percentage of participants|||Number
1345109|NCT01870921|Secondary|Major CV Events|Combination of CV death, MI, and stroke|12 months||||Participants|||Number
1345110|NCT01870921|Primary|Serious Adverse Events Other Than Bleeding|SAEs except the blending events which have aleady been reported as SAEs.|12 months||||Participants|||Number
1345111|NCT01870921|Primary|Bleeding Events|PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal|12 months||||Participants|||Number
1345112|NCT01870856|Secondary|Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2|||||||
1345113|NCT01870856|Primary|Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2|||||||
1345114|NCT01870856|Primary|Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.|Baseline, Week 2|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points.|||percentage of subjects|||Number
1345115|NCT01870843|Secondary|Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method.|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
1345116|NCT01870843|Secondary|Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
1345117|NCT01870843|Secondary|Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
1345118|NCT01870843|Secondary|Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms.|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.|||Units on a scale||95% Confidence Interval|Mean
1345119|NCT01870843|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.|||Units on a scale||95% Confidence Interval|Mean
1345120|NCT01870843|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56|"The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and it ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.|||Units on a scale||95% Confidence Interval|Mean
1345121|NCT01870843|Secondary|Treatment Improvement Rate at the End of Week 1 and Week 2|"Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Week 1 and Week 2|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Participants|||Number
1345148|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - Tmax|Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
1345122|NCT01870843|Secondary|Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
1345123|NCT01870843|Primary|Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56|"SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from 0 = unimpaired to 30 = highly impaired. Higher scores indicate worsening."|Baseline, Day 14, Day 28, Day 42, and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Units on a scale||Standard Deviation|Mean
1345124|NCT01870843|Primary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56|"Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening."|Baseline, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Units on a scale||Standard Deviation|Mean
1345125|NCT01870778|Secondary|Change From Baseline in Cystatin C Biomarker|Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented.|Baseline, Day 2, Day 5 and Day 14|Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.|||mg/L||95% Confidence Interval|Least Squares Mean
1345126|NCT01870778|Secondary|Change From Baseline in NT-proBNP Biomarker|Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented.|Baseline, Day 2, Day 5 and Day 14|Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.|||pg/mL||95% Confidence Interval|Geometric Least Squares Mean
1345127|NCT01870778|Secondary|Change From Baseline in hsTroponin T Biomarker|Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented.|Baseline, Day 2, Day 5 and Day 14|Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.|||ug/L||95% Confidence Interval|Geometric Least Squares Mean
1345128|NCT01870778|Secondary|Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure|The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema.|From baseline to Day 5|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was considered for the analysis. For each symptom, only participants with observed baseline signs and symptoms and non-missing baseline and post baseline signs and symptoms were analyzed.|||Percentage of participants|||Number
1345129|NCT01870778|Secondary|Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization|Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day.|180 days (Patients still in the hospital at Day 60 were censored at Day 60)|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||days||Standard Deviation|Mean
1345130|NCT01870778|Secondary|Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization|The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed.|180 days|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
1345131|NCT01870778|Secondary|Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization|Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day.|180 days (Participants still in the hospital at Day 60 were censored at Day 60)|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||days||Standard Deviation|Mean
1345132|NCT01870778|Secondary|Percentage of Participants With All-cause Death Through Day 180|The percentage of participants with all-cause death through day 180 was assessed.|180 days|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
1345133|NCT01870778|Primary|Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5|The percentage of participants with WHF through day 5 was assessed.|Day 5|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
1345136|NCT01870739|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks|For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis|||meters per second (m/s)||Standard Error|Least Squares Mean
1345137|NCT01870739|Secondary|Change From Baseline in Augmentation Index at 52 Weeks|Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis|||percent||Standard Error|Least Squares Mean
1345138|NCT01870739|Secondary|Change From Baseline in Augmentation Pressure at 52 Weeks|Augmentation pressure is the added pressure during systole due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
1345139|NCT01870739|Secondary|Change From Baseline in Central Blood Pressure at 52 Weeks|Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
1345140|NCT01870739|Secondary|Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||meters per second (m/s)||Standard Error|Least Squares Mean
1345141|NCT01870739|Secondary|Change From Baseline in Local Aortic Strain at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||percent||Standard Error|Least Squares Mean
1345142|NCT01870739|Primary|Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
1345143|NCT01870739|Primary|Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
1345144|NCT01870739|Primary|Change From Baseline in Ascending Aorta Distensibility at 52 Week|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
1345145|NCT01870726|Secondary|Overall Survival (OS)|"Survival rate of patients from start of treatment to date of death due to any cause.~Patients did not reach the milestone for the survival data analysis (terminated early); as such no analysis was done."|throughout the duration of the trial - approximately 3 years (FPFV to LPLV)|Based on the phase I, a RP2D was not determined for the combination arm (Phase II combination arms were not opened). Patients did not reach the milestone needed for the OS analysis (at minimum the Bayesian model requires 30 patients) due to early termination, as such no analysis for OS was done.||||||
1345146|NCT01870726|Secondary|Best Overall Response (BOR)|"Best Overall Response (BOR) observed in the study population of INC280 Single Agent and in Combination with Buparlisib. Responses will be assessed by the investigators following the RANO criteria with MRI or CT scans scheduled every 8 weeks.~Summary of the RANO response criteria: CR has no T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PR has ≥50% decrease T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; SD has ≥50% decrease but <25% increase T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PD has ≥25% increase in T1-Gd+ (enhancing lesion), increase T2/FLAIR (non-enhancing lesion), presence of new lesion, deterioration in clinical status."|throughout the duration of the trial - approximately 3 years (from FPFV to LPLV)|FAS|||Participants|||Number
1345149|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - Cmax|Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||ng/ml||Full Range|Median
1345150|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - AUCtau|Plasma concentration profile of Buparlisib in combination with INC280. AUCtau is the AUC from time zero to the end of dosing interval.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr*ng/ml||Full Range|Median
1345151|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - T1/2|Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
1345152|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - Tmax|Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
1345153|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - Cmax|Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||ng/ml||Full Range|Median
1345154|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - AUCtau|Plasma concentration profile of INC280 in combination with Buparlisib. AUCtau is the AUC from time zero to the end of dosing interval.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr*ng/ml||Full Range|Median
1345155|NCT01870726|Secondary|Number of Participants With Adverse Events|"To characterize the safety of INC280 single agent and in combination with buparlisib including type, frequency, severity of adverse events, serious adverse events, and dose interruptions and adjustments. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, unless otherwise specified.~If CTCAE grading did not exist for an AE, the severity of mild, moderate, severe, and lifethreatening, corresponding to Grades 1 - 4, were used. CTCAE Grade 5 (death) was not used in this study but was collected as a seriousness criterion; rather, information about deaths was collected though a Death form."|throughout the duration of the trial, approximately 3 years from FPFV to LPLV|Safety Analysis Set (SAS): The SAS comprised all patients who received at least one full or partial dose of study treatment. Patients were analyzed according to the treatment actually received. The SAS was used for all safety analyses.|||Participants|||Number
1345156|NCT01870726|Primary|Phase II Surgical Arm: Concentrations of INC280 and Buparlisib in Tumor.|Concentrations of INC280 and buparlisib in tumor tissue.|7 days|Based on the phase I, a RP2D was not determined for the combination and the phase II combination arms were not opened.||||||
1345157|NCT01870726|Primary|Phase II: Progression Free Survival Rate (PFSR)|"Estimated rate of patients treated during 6 months without experiencing disease progression.~The Progression Free Survival Rate at 6 months was to be estimated using a Bayesian model described in the protocol. The models operating characteristics were evaluated based on the enrollment of at least 30 patients enrolled. Patients did not reach the milestone for the PFSR analysis (trial terminated); as such no analysis was performed."|6 months|Based on the phase I, a RP2D was not determined for the combination arm (Phase II combination arms were not opened). Patients did not reach the milestone needed for the PFSR analysis (at minimum the Bayesian model requires 30 patients) due to early termination, as such no analysis for PFSR was performed.||||||
1345158|NCT01870726|Primary|Number of Patients Reporting Dose Limiting Toxicities (DLTs) in Cycle 1|A DLT is defined as an adverse event or abnormal laboratory value where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment (28 days) with INC280 in combination with buparlisib and meets any of the pre-defined criteria. The maximum tolerated dose was identified as INC280 300 mg BID + buparlisib 80 mg QD.|Cycle 1, 28 days|Dose determining set (DDS) consisted of all patients from the SAS who either met the minimum exposure criterion and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.|||Number of Patients|||Number
1345159|NCT01870596|Primary|Response Rate(CR/CRi) Rate|For descriptive purposes, the CR/CRi (complete response/Complete response with incomplete blood count recovery) rate will be reported at the end of the study separately for Arm A and Arm B. Responses are following definitions consistent with those published by Dohner H, Estey EH, Amadori S, et al. CR is defined as Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blasts in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. CRi: All CR criteria except for residual neutropenia (ANC < 1000/μL)|Up to 3 years||||participants|||Number
1345160|NCT01870583|Primary|Cesarean Surgical Site Infection|Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.|42 days after delivery||||Participants|||Count of Participants
1345161|NCT01870388|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib||Predose up to 48 h postdose|Participants who received 1 dose of study drug and had evaluable PK data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1345162|NCT01870388|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)||Predose up to 48 hours (h) postdose|Participants who received 1 dose of study drug and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1345165|NCT01869959|Secondary|Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score|Change from baseline to Day 28 in the PHQ-9 total score is presented. Participants were asked to score the severity of depressive symptoms over the last 2 weeks. Items were scored 0 (not at all), 1 (several days), 2 (half of the days), or 3 (nearly every day). The total PHQ-9 score is the sum of the score for each item and range from 0 to 27. A score of 0 means low depression severity and a score of 27 means high depression severity. Depression severity will be given a quality rating based on the total PHQ-9 score, as follows: None (0-4); Mild (5-9); Moderate (10-14); Moderately severe (15-19); and Severe (20-27). The PHQ-9 measurement obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable PHQ-9 data.|||units on a scale||90% Confidence Interval|Least Squares Mean
1345166|NCT01869959|Secondary|Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score|The table below represents the change from baseline in FPQ total score. The FPQ was administered to assess overall preference for foods of different macronutrient contents utilizing a macronutrient self-selection paradigm. Participants rated their preference on a range from 1 to 9 with 1 (dislike extremely) to 9 (like extremely) for a battery of 72 commonly consumed foods with fat content varying significantly in sugar, complex carbohydrates, and protein. The total score was calculated by averaging preference scores of 72 items. A low mean score of 1 to 9 scale indicate a low preference for the foods listed and a high mean score indicate a high preference for the foods listed. The FPQ measurement on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable FPQ data.|||units on a scale||90% Confidence Interval|Least Squares Mean
1345167|NCT01869959|Secondary|Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger|Change from baseline to Day 28 in Eating Inventory (EI) subscales are presented. The EI is a 51-item inventory that measures dietary restraint (the cognitive intention to restrict energy intake; scores range from 0 to 21), disinhibition (the tendency to episodically overeat, often in response to external cues; scores range from 0 to 16), and perceived hunger (scores range from 0 to 14). A low score indicates a low exhibition of behavior and a high score indicates a high exhibition of behavior. The measurement for each variable obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable EI data.|||units on a scale||90% Confidence Interval|Least Squares Mean
1345168|NCT01869959|Secondary|The Number of Participants With Anti-LY2405319 Antibodies|The number of participants that tested positive for anti-LY2405319 antibodies is presented.|Day 1 through Day 56|All participants who received at least 1 dose of study drug with evaluable anti-LY2405319 antibody data.|||number of participants|||Number
1345169|NCT01869959|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319|Cmax of LY2405319 is presented. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.|Predose through Day 28 (48 hours postdose)|All participants who received at least 1 dose of study drug with evaluable Cmax of LY2405319 data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1345170|NCT01869959|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319|AUC for LY2405319 is presented. Data represent AUC for 1 dosing interval at steady state. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.|Predose through Day 28 (48 hours postdose)|All participants who received at least 1 dose of study drug with evaluable AUC of LY2405319 data.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1345171|NCT01869959|Secondary|Change From Baseline to Day 28 in C-Reactive Protein|Change from baseline to Day 28 in C-reactive protein is presented. The predose C-reactive protein measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable C-reactive protein data.|||milligrams per liter (mg/L)||90% Confidence Interval|Least Squares Mean
1345172|NCT01869959|Secondary|Change From Baseline to Day 28 in Adiponectin|Change from baseline to Day 28 in adiponectin is presented. The predose adiponectin measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, treatment times day as fixed effects, baseline as covariate, and participant as random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable adiponectin data.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
1345173|NCT01869959|Secondary|Change From Baseline to Day 28 in Body Weight|Change from baseline to Day 28 in body weight is presented. The predose body weight measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, time, and treatment times time, treatment times day, and treatment times day times time were fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable body weight data.|||kilograms (kg)||90% Confidence Interval|Least Squares Mean
1345174|NCT01869959|Secondary|Change From Baseline to Day 28 in Fasting Lipid Profile|Change from baseline to Day 28 in fasting lipids, including cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides is presented. The predose measurement for each variable on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable fasting lipid (ie, cholesterol, LDL-C, HDL-C, and triglyceride) data.|||milligrams per deciliter (mg/dL)||90% Confidence Interval|Least Squares Mean
1345191|NCT01869686|Secondary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Serum|The area under the denosumab serum concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||days*ng/mL||Standard Deviation|Mean
1345175|NCT01869959|Secondary|Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC)|Change from baseline to Week 4 in C-peptide AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as a fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable C-peptide AUC data.|||nanograms*hours/milliliter (ng*hr/mL)||90% Confidence Interval|Least Squares Mean
1345176|NCT01869959|Secondary|Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC)|Change from baseline to Week 4 in insulin AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable insulin (AUC) data.|||micro International units*hour/mL||90% Confidence Interval|Least Squares Mean
1345177|NCT01869959|Secondary|Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC)|Change from baseline to Week 4 in glucose AUC during an oral glucose tolerance test (OGTT) is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable glucose AUC data.|||milligrams*hr per deciliter (mg*hr/dL)||90% Confidence Interval|Least Squares Mean
1345178|NCT01869959|Secondary|7 Point Self-monitored Blood Glucose (SMBG)|The daily mean of the 7-point SMBG values is presented. Seven-point glucose profiles were measured by participants at baseline and at Week 4. The 7-point SMBG mean on Days -5, -4, or -3 served as the baseline value; the 7-point SMBG mean on Days 24, 25, or 26 served as the Week 4 value. Blood glucose was measured before and 2 hours after each meal and at bedtime.|Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26)|All participants who received at least 1 dose of study drug with evaluable 7-Point SMBG data.|||mg/dL||Standard Error|Mean
1345179|NCT01869959|Secondary|Change From Baseline to Day 28 in Fasting Glucose|Change from baseline to Day 28 in fasting blood glucose is presented. The predose fasting blood glucose measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|Participants who received at least 1 dose of study drug with evaluable blood glucose data.|||milligrams per deciliter (mg/dL)||90% Confidence Interval|Least Squares Mean
1345180|NCT01869959|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 56|All participants who received at least 1 dose of study drug.|||number of participants|||Number
1345181|NCT01869699|Secondary|2-hour Change Over Time Heart Rate|2-hour change over time heart rate from time of study drug administration (means adjusted to baseline HR)|Baseline to 2 hours||||BPM||Standard Error|Mean
1345182|NCT01869699|Secondary|2-hour Change Over Time Systolic Blood Pressure|2-hour change over time SBP from study drug administration (means adjusted to baseline SBP)|Baseline to 2 hours||||mm Hg||Standard Error|Mean
1345183|NCT01869699|Secondary|2-hour Change Over Time Core Temperature|change over time core temperature after study drug administration (adjusted to baseline core temperature)|2 hours||||degrees Celsius||Standard Error|Mean
1345184|NCT01869699|Secondary|Respiratory Rate|time weighted average for respiratory rate over 4 hours. Respiratory rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the respiratory rate values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in the ICU with fever, weight of > 50kg and no exclusion criteria met.|||breaths per minute||Standard Error|Mean
1345185|NCT01869699|Secondary|Systolic Blood Pressure|time-weighted average systolic blood pressure over 4 hours. Systolic blood pressure was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the systolic blood pressure values was divided by time in minutes.|Baseline to 4 hours post study drug administration||||mm Hg||Standard Error|Mean
1345186|NCT01869699|Secondary|Heart Rate|time-weighted average heart rate over 4 hours. Heart rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the heart rate values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in the ICU with fever, weight of > 50kg and no exclusion criteria met.|||beats per minute||Standard Error|Mean
1345187|NCT01869699|Primary|Core Body Temperature|time-weighted average core body temperature over 4 hours. Core temperature was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the core temperature values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in an ICU with fever, weighed > 50kg and did not meet any exclusion criteria.|||degrees Celsius||Standard Error|Mean
1345188|NCT01869686|Secondary|Ratio of Denosumab Seminal Fluid Concentration Over the Denosumab Serum Concentration at the Last Study Time Point (Day 106).||Day 106|Pharmacokinetic population with available data|||ratio||Standard Deviation|Mean
1345189|NCT01869686|Secondary|Ratio of Seminal Fluid AUC by Serum AUC for the 106 Day Dosing Period|The ratio of denosumab seminal fluid AUC over denosumab serum AUC for the 106-day dosing period.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||ratio||Standard Deviation|Mean
1345190|NCT01869686|Secondary|Ratio of Maximum Seminal Fluid Concentration by the Serum Concentration (Cmax Ratio)|The ratio of maximum denosumab seminal fluid concentration over the denosumab serum concentration at the corresponding time point (Cmax Ratio)|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data|||ratio||Standard Deviation|Mean
1345194|NCT01869686|Primary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Seminal Fluid|The area under the denosumab seminal fluid concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||days*ng/mL||Standard Deviation|Mean
1345195|NCT01869686|Primary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data|||days||Full Range|Median
1345196|NCT01869686|Primary|Maximum Observed Concentration (Cmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
1345197|NCT01869647|Secondary|Prevalence of Urological Intervention|This measure presents the prevalence of participants needing urological intervention in each arm within 90 days.|90 days||||participants|||Number
1345198|NCT01869647|Primary|Radiation Exposure (Dose-Length-Product) at Baseline|Radiation exposure at baseline was collected using the mean dose length product mGy*cm.|Baseline (at enrollment)||||mGy*cm||95% Confidence Interval|Mean
1345199|NCT01869478|Secondary|Mean Score on Modified Rankin Scale at 90 Days|Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).|90 days|Only one participant was enrolled, so data analysis was not possible.||||||
1345200|NCT01869478|Primary|Recanalization Rate of Primary Intracranial Occlusion|The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).|24 hours|Only one participant was enrolled, so data analysis was not possible.||||||
1345201|NCT01869439|Primary|Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter|Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.|90 Days|40 wounds captured in an inpatient and outpatient population.|||percentage of CV||Geometric Coefficient of Variation|Geometric Mean
1345202|NCT01869348|Other Pre-specified|Acceptability|Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability|12 weeks|||||||
1345203|NCT01869348|Other Pre-specified|Feasibility|We will use many different measures of feasibility, including adherence to study protocol, attrition, barriers to adherence, exposure/dose of intervention received, and any adverse events that occur|12 weeks|||||||
1345204|NCT01869348|Secondary|Change in Weight From Baseline to 12 Weeks|We will measure weight (and height at baseline) using a calibrated scale|12 weeks|||||||
1345205|NCT01869348|Secondary|Change in Physical Function From Baseline to 12 Weeks|Functional measurements will be made using the Senior Fitness Test|12 weeks|||||||
1345206|NCT01869348|Secondary|Change in Body Composition From Baseline to 12 Weeks|We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass|12 weeks|||||||
1345207|NCT01869348|Secondary|Change in Physical Fitness From Baseline to 12 Weeks|We will use the six minute walk test to measure physical fitness|12 weeks|||||||
1345208|NCT01869348|Secondary|Change in Autonomous Motivation From Baseline to 12 Weeks|We will measure feelings of autonomous and controlled motivation/regulation for physical activity|12 weeks|||||||
1345209|NCT01869348|Secondary|Change in Sedentary Behavior From Baseline to 12 Weeks|Minutes of total sedentary time measured over a seven day period|12 weeks|||||||
1345210|NCT01869348|Primary|Change in Physical Activity From Baseline to 12 Weeks|Minutes of physical activity measured over a seven day period|12 weeks||||minutes||Standard Deviation|Mean
1345211|NCT01869075|Primary|Percentage of Patients Prescribed Appropriate VTE Prophylaxis|"Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk.~Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control.~Appropriate VTE prophylaxis was defined as:~in Hip Fracture Surgery - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in Major General Surgery - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in Acute Medical Illness - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay.~Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study."|End of study (end of phase 2) - measured over duration of hospital stay.|The number of participants in the analysis was 720. In phase 1, there were 360 patients included and in phase 2, an additional 360 patients were included. The outcomes by end of study (end of phase 2) are reported. The patients in control (usual care) and intervention (Knowledge Translation toolkit) were compared.|||percentage of patients|||Number
1345212|NCT01868997|Secondary|Overall Average Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM)|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 100 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1345221|NCT01868789|Primary|Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing|Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.|1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing||||degrees||Standard Deviation|Mean
1345213|NCT01868997|Secondary|Overall Average Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM)|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 100 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1345214|NCT01868997|Secondary|Overall Average Change From Baseline in CAS to Week 24 (MMRM)|The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1345215|NCT01868997|Secondary|Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM)|Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded using the Hertel exophthalmometer. Participants with a decrease ≥ 2 mm were considered improving, those with an increase or decrease < 2 mm were considered remaining stable, and those with an increase ≥ 2 mm were considered worsening.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||mm||Standard Error|Least Squares Mean
1345216|NCT01868997|Secondary|Overall Average Change From Baseline in Graves’ Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM])|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid eye disorder (TED) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health).|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1345217|NCT01868997|Primary|Responder Status at Week 24|Number of participants classified as responders and non-responders at Week 24. Responders were defined as participants with a reduction in clinical activity score (CAS, see Outcome Measure 4 description for details) of ≥ 2 points, and a reduction in proptosis (amount of protrusion of the eye from the orbital rim) of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye. Participants who had no assessment at 24 weeks were considered non-responders.|Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo).|||Participants|||Count of Participants
1345218|NCT01868893|Secondary|Number of Participants With Objective Response|Objective response is defined as either complete response [CR], complete response with incomplete recovery [CRi], or partial response [PR] as determined by the treating physician’s standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).|Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)|Efficacy evaluable population: It included participants who received at least one dose of study drug and had measurable disease at baseline and at least one post-baseline tumor assessment or who died within 28 days after the last dose of the study drug|||participants|||Number
1345219|NCT01868893|Secondary|Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 28 days after the last dose of study drug (up to 7 months from Day 1)|Safety Population: It included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1345220|NCT01868893|Primary|Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study|Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.|Cycles 1 to 6 (28-day cycles)|Intent-to-Treat population: It included all enrolled participants in the study.|||participants|||Number
1345337|NCT01866592|Primary|Change in Cardiometabolic Biomarkers: - Total Cholesterol|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and the start of adalimumab - Total Cholesterol|52 weeks of adalimumab treatment||||mg/dL||Standard Error|Mean
1345222|NCT01868789|Primary|Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular|Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.|1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing||||mm||Standard Deviation|Mean
1345223|NCT01868776|Primary|Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.|100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.|approximately 15 minutes after injection||||percentage of participants|||Number
1345224|NCT01868776|Primary|Pain Measurement as Assessed on a Visual Analog Scale||pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection||2015-12-31|12/2015||||
1345225|NCT01868633|Other Pre-specified|Number of Participants With Chronic Pain After Cesarean Delivery|Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups|6 months|Study participants had a telephone call follow-up 6 months after cesarean delivery by a research nurse. They were asked questions about current pain symptoms and if it is related to their cesarean delivery. Seven patients in the dexamethasone group and eight patients in the placebo did not respond when contacted|||Participants|||Count of Participants
1345226|NCT01868633|Secondary|Incidence and Severity of Nausea and Pruritus|Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)|24 hours||||units on a scale||Inter-Quartile Range|Median
1345227|NCT01868633|Secondary|Quality of Recovery|Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group|48 hours|Two patients in the dexamethasone group and 8 patients in the placebo did not complete the quality of recovery questionnaire.|||units on a scale||Standard Deviation|Mean
1345228|NCT01868633|Secondary|Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery|Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with “no pain” = 0 and “the worst possible pain = 10). Pain was assessed at rest and with movement|24 hours||||units on a scale||Inter-Quartile Range|Median
1345229|NCT01868633|Primary|Postoperative Analgesia|Comparison of postoperative opioid analgesia use between the 2 groups|24 hours||||milligrams of morphine||Inter-Quartile Range|Median
1345230|NCT01868542|Secondary|Incidence of Adverse Events|A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20)|Week 20|"Safety analysis set - included all subjects receiving at least one dose of the trial product. Subjects in the safety set contributed to the evaluation as treated."|||events|||Number
1345231|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.|||mg/dL||Standard Deviation|Mean
1345232|NCT01868542|Secondary|Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms.|For 20 weeks of treatment and over 24 hours|Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”.|||Episodes|||Number
1345233|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|week 0, week 12|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.|||mg/dL||Standard Deviation|Mean
1345234|NCT01868542|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%|Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment.|Week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm ) arm.|||percentage (%) of subjects|||Number
1345235|NCT01868542|Secondary|Change in HbA1c|Change in HbA1c at 12 weeks of treatment from visit 2.|Week 0, week 12|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8)algorithm arm.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1345236|NCT01868542|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.|Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1345237|NCT01868503|Secondary|Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes|Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.|Up to 12 weeks|Of the patients in the treatment arm, only 1 received surgery.|||Participants|||Count of Participants
1345238|NCT01868503|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events will be tabulated by organ system and severity.|Up to 12 weeks|Participants enrolled in the study.|||incidencts|||Number
1345239|NCT01868503|Secondary|Change in the Proportion of BCSCs|Defined as the difference between the percentage of BCSCs before and after treatment. Proportion of biopsy samples that are evaluable for BCSCs will be estimated along with 95% exact confidence intervals. BCSC results will be summarized using medians and interquartile ranges. Changes in BCSCs will be assessed using the Wilcoxon signed rank test.|Baseline to 12 weeks|This outcome was not analyzed due to lack of funding. It may be re-evaluated in the future. Data were not collected and the outcome measure was not analyzed.||||||
1345240|NCT01868503|Secondary|Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP|Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.|12 weeks|Data were not collected and the outcome measure was not analyzed.||||||
1345241|NCT01868503|Primary|Percentage of Patients Achieving Complete Clinical Response|Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).|Up to 12 weeks||||Participants|||Count of Participants
1345242|NCT01868334|Secondary|Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2|Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2|% vaccinated by 1/31/2015||||percent change in vaccination rates|||Number
1345243|NCT01868334|Primary|Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1|Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1|% vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)||||percent change in vaccination rates|||Number
1345244|NCT01868243|Secondary|Spontaneous Echo Contrast|Spontaneous Echo Contrast showed in Transesophageal echocardiography|90 days||||participants|||Number
1345245|NCT01868243|Primary|Intracardiac Thrombus|The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).|90 days|A total of 34 patients were selected between August 2013 and November 2014 (6 were excluded for previous intracardiac thrombus; 1 for unstable INR control). Of the 27 randomized, 15 were assigned to receive dabigatran and 12 to receive warfarin.|||participants||95% Confidence Interval|Number
1345246|NCT01868074|Secondary|Change in CPEI (3mph)|The Center of Pressure Excursion Index (CPEI) is a measurement of the lateral displacement of the center of pressure curve from a reference line drawn from the initial to the final centers of pressure during stance phase of gait, and standardized to the width of the anterior third of the foot during pedobarography.|baseline, 8 weeks postpartum||||ratio||Standard Error|Mean
1345247|NCT01868074|Secondary|Change in Arch Rigidity|The arch rigidity index, a measure of the ability of the foot to maintain the arch when weight-bearing, was determined by dividing the standing AHI by the seated AHI. A value of 1.0 would indicate a perfectly rigid arch, while smaller values would indicate a more flexible arch.|baseline, 8 weeks postpartum||||ratio||Standard Error|Mean
1345248|NCT01868074|Primary|Change in Arch Drop|Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System|baseline, 8 weeks postpartum||||mm||Standard Error|Mean
1345249|NCT01868035|Secondary|Overall Survival|Overall survival (time to death) is defined from the start of treatment to the date of death from any cause.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||months||95% Confidence Interval|Median
1345250|NCT01868035|Secondary|Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured.|Baseline; any follow-up visit (up to 72 months)|ITT Population|||participants|||Number
1345251|NCT01868035|Secondary|Number of Participants Needing Supportive Care at Week 7 and Week 13|During the administration of unlabeled Anti-B1 antibody and Iodine-131 Anti-B1 antibody, emergency support for anaphylaxis, including epinephrine, diphenhydramine, hydrocortisone, a laryngoscope, and an endotracheal tube, was readily available. The use of steroids were discouraged unless other measures were ineffective.|Week 7 and Week 13|ITT Population|||participants|||Number
1345252|NCT01868035|Secondary|Time to Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Nadir is defined as the lowest counts (for ANC, WBC, and platelet counts)/concentration (for hemoglobin) that the cells reach after chemotherapy. Time to nadir is defined as the time from Baseline to the lowest value recorded up to 120 days following the therapeutic dose.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||days||Standard Deviation|Mean
1345253|NCT01868035|Secondary|Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), hemoglobin, platelet count, WBC count. Nadir is defined as lowest counts that the cells reach after chemotherapy.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||10^3 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
1345254|NCT01868035|Secondary|Time to Recovery From the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Time to recovery to Baseline grade for participants with Grade 0 toxicity at Baseline was defined as the time from the date of the last administration of study drug to the first post-nadir date with Grade 0 toxicity, with no other Grade 1-4 toxicities recorded during the next week. For participants with a Grade 1-4 toxicity at Baseline, time to recovery was defined as the time from the last administration of study drug to the first post-nadir date with a Baseline grade or better, with no other higher grade toxicities recorded during the next week. For participants with a nadir grade less than or equal to the Baseline grade, the time to recovery to the Baseline grade equaled the time to nadir.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||days||95% Confidence Interval|Median
1345255|NCT01868035|Secondary|Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a casual relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or significant worsening of a pre-existing sign or symptom, or disease temporally associated with the use of a medicinal product. An SAE is defined as any experience occurring at any dose that results in the following outcomes: death, a life-threatening adverse experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. See the SAE/AE module for a complete list of SAEs/AEs.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||participants|||Number
1345256|NCT01868035|Secondary|Total Body Residence Time (TBRT)|TBRT is the time at which the activity of infusion is 37% of that at time zero. Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. The assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the TBRTs. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||hours||Standard Deviation|Mean
1345257|NCT01868035|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the start of treatment to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||months||95% Confidence Interval|Median
1345258|NCT01868035|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the start of treatment to the first documented progression or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||months||95% Confidence Interval|Median
1345259|NCT01868035|Secondary|Duration of Response and Duration of Confirmed Complete Response|Duration of response for all participants with confirmed PR, confirmed CRu, or confirmed CR is defined as the time from the first documented response to the first documented progression. CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and the normalization of biochemical abnormalities definitely assignable to NHL. PR is defined as a >=50% decrease in the sum of the perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. Only those participants with a confirmed response were analyzed. Duration measures were calculated using Kaplan-Meier techniques.|||months||95% Confidence Interval|Median
1345260|NCT01868035|Secondary|Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)|CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to non Hodgkin's lymphoma (NHL). PR is defined as a >=50% decrease in the sum of perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. SD is defined as less than a PR, but not PD, which is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. RD is defined as the appearance of any new lesion or an increase of >= 50% in the size of nodules. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. A con. CR+CRu requires that the best response be con. by the same response or better >=4 weeks apart. The individual rows for con. CR, CRu, and PR represent par. with the best response con. by the same exact response. One par. in the CR+CRu category is not counted in the con. CR category because the CR was not con. by another CR.|||participants|||Number
1345261|NCT01868035|Primary|Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody|Hematology parameter grades were summarized according to the National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) <1000 cells/millimeters cubed (mm^3), white blood cells (WBC) <2000 cells/mm^3, platelets <50000 cells/mm^3, and hemoglobin < 8.0 grams/deciliter.|From Baseline until Week 25 and follow-up (up to 130 months)|Intent-to-treat (ITT) Population: all participants who received study drug|||participants|||Number
1345262|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Size of the Device|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence.|up to Study Day 26|PP Population. Only those participants responding to the question regarding the specified attribute were analyzed.|||Participants|||Number
1345263|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence.|up to Study Day 26|PP Population|||Participants|||Number
1345264|NCT01868009|Primary|Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.|up to Study Day 26|Per Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (comprised of all participants who had been randomized and received one dose of at least one study inhaler) who completed at least one question from the seven preference questions|||participants|||Number
1345265|NCT01867710|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12|The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline.|Week 12|Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
1345266|NCT01867710|Primary|Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment|No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.|Week 24|Safety population included all randomized and treated participants. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
1345267|NCT01867658|Secondary|Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up|The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.|Baseline and One (1) Month Follow-up|MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure.|||units on a scale||Standard Deviation|Mean
1345268|NCT01867658|Secondary|Duration of Hospitalization (Length of Stay)||Days 0-20|MITT Population minus 2 subjects who died prior to discharge|||Days||Standard Deviation|Mean
1345269|NCT01867658|Secondary|Duration of Chest Tube Drainage||Day 0-46|MITT Population minus 1 subject with missing data|||Days||Standard Deviation|Mean
1345270|NCT01867658|Secondary|Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals||Day 0-46|MITT population minus 1 subject with missing data.|||Days||Standard Deviation|Mean
1345271|NCT01867658|Secondary|Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery||Day 0||||Participants|||Count of Participants
1345272|NCT01867658|Secondary|Percentage of Air Leaks That Are Sealed or Reduced||Day 0|Subjects in the mITT population|||percentage of air leaks|Number of Air Leaks|95% Confidence Interval|Number
1345273|NCT01867658|Secondary|Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up||One (1) month|MITT Population|||percentage of participants||90% Confidence Interval|Number
1345274|NCT01867658|Primary|Rate of Device and/or Procedure-related Adverse Events|The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.|One (1) month follow-up|Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation.|||percentage of participants||90% Confidence Interval|Number
1345275|NCT01867632|Secondary|Number of Participants With Wound Infection|Number of Participants with Wound Infection post cleft palate repair|Within 1 year of surgery||||Participants|||Count of Participants
1345276|NCT01867632|Primary|Fistula Formation|Number of patients who developed post palatoplasty fistula|Within 1 year of surgery||||participants|||Number
1345277|NCT01867580|Post-Hoc|Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds||until the wound is deemed ready for closure or coverage by the investigator up to 64 days|This only included those patients with wound etiology of Surgically Dehisced Wounds|||Participants|||Count of Participants
1345278|NCT01867580|Secondary|The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.||Immediately following initial post debridement to the first dressing change up to 72 hours|Per-protocol population (some subjects had missing assessments)|||Total Bacterial Counts (Log10 CFU)||Standard Deviation|Mean
1345279|NCT01867580|Primary|Number of Inpatient Operating Room Debridements|Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room|until the wound is deemed ready for closure or coverage by the investigator up to 64 days|Per-protocol population|||Participants|||Count of Participants
1345280|NCT01867515|Primary|Percent Correct Words Identified|The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.|average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart||||percentage of words identified||Full Range|Mean
1345281|NCT01867424|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|From date treatment consent signed to date off study, approximately 3 years and 33 days||||Participants|||Count of Participants
1345282|NCT01867424|Secondary|Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection|Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated to baseline PSA levels.|Baseline|Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.|||ng/mL||Standard Deviation|Mean
1345283|NCT01867424|Secondary|Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score|Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated with baseline Gleason score obtained from the prostate biopsy. Gleason score <7 = low grade cancer; Gleason score ≥7 = high grade cancer.|At baseline|Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.|||Participants|||Count of Participants
1345284|NCT01867424|Primary|Uptake and Retention of Eovist in Prostate Cancers|Uptake and retention of Eovist in prostate cancers is measured by the change of magnetic resonance imaging (MRI) parameter values between pre and post injection.|Baseline and 20 minutes after Evoist injection|Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.|||contrast enhancement ratio (CER)||Standard Deviation|Mean
1345285|NCT01867307|Primary|Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)|"Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Day 14).~Per-protocol set (PPS): PPS consisted of all subjects and patients in the TS who completed the treatment day 14 clamping study without any relevant deviations either in their treatment regimen or in the performance and timing of the measurements."|Baseline and Day 14|Analysable set (AS): This data set is based on the PPS and excluded all primary endpoint and exploratory endpoint data for one healthy subject due to outlying values that were identified in the subject’s TmG and urine splay data.|||(milligram / minute/ 1.73 square meters)||Standard Deviation|Mean
1345286|NCT01867216|Secondary|Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀₋₁₂) During Mixed Meal Tolerance Test at Day 28||Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose|All participants who received study drug and had sufficient evaluable c-peptide values.|||picomoles*h per liter (pmol*h/L)||Standard Deviation|Mean
1345287|NCT01867216|Secondary|Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀₋₂₄) During Mixed Meal Tolerance Test at Day 28||Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose|All participants who received study drug and had sufficient evaluable blood glucose values.|||mg*h/dL||Standard Deviation|Mean
1345288|NCT01867216|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28||Baseline, Day 28|All participants who received study drug and had sufficient evaluable HbA1c values.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1345289|NCT01867216|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470||Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose|All participants who received LY2922470 and had sufficient evaluable Tmax values. For BID arms, Tmax from time 0-6 hours.|||hours||Full Range|Median
1345290|NCT01867216|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470||Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose|All participants who received LY2922470 and had sufficient evaluable Cmax values. For BID arms, Cmax from time 0-6 hours.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1345291|NCT01867216|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470||Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose|All participants who received LY2922470 and had sufficient evaluable AUC(0-24) values.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1345292|NCT01867216|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.|Baseline through Study Completion (up to 56 days)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1345293|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Physician|Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
1346326|NCT01851330|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1345294|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Participant|Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
1345295|NCT01867164|Primary|Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment|Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' signifies participants who were evaluated for this outcome measure including the participants for whom no culture was performed.|||Percentage of Participants|||Number
1345296|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
1345297|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
1345298|NCT01867086|Other Pre-specified|Number of Alive Subjects|Survival status of patients after treatment will be determined.|24 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 24 months, subject was not alive. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
1345299|NCT01867086|Secondary|Immune Analysis in Blood|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.|Baseline, End of Treatment (30 days after last dose) up to 12 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 12 months, subject had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
1345300|NCT01867086|Primary|Response Rate|Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.|Up to 12 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
1345301|NCT01867086|Primary|Time to Progression (TTP)|Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.|24 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
1345302|NCT01867047|Post-Hoc|Length of Stay|Length of stay in days|Discharge from hospital (approximately 5 days)||||Days||Full Range|Median
1345303|NCT01867047|Secondary|Number of Participants With Acute Kidney Injury|Number of participants with acute kidney injury will be recorded.|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
1345304|NCT01867047|Secondary|Number of Participants That Received Allogeneic Blood|The number of participants that received allogeneic blood will be recorded.|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
1345305|NCT01867047|Secondary|Number of Participants Transferred to Intensive Care Unit (ICU)|The number of participants transferred to Intensive Care Unit (ICU) will be recorded|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
1345306|NCT01867047|Primary|Number of Participants Given Vasopressors|The number of participants who received vasopressors.|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
1345307|NCT01867047|Primary|Number of Participants With Severe Hypotension|The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded.|From baseline to discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
1345308|NCT01867047|Primary|Number of Participants With Mild Hypotension|The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.|From baseline to discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
1345309|NCT01867021|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.|Day 1 to 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
1345310|NCT01867021|Secondary|Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).|Day 22|Analysis was done on the PPS1|||Ratios||95% Confidence Interval|Geometric Mean
1345311|NCT01867021|Secondary|Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|"Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22).~Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine.~According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (<65 years) or ≥30% (≥65 years).~As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (<65 years) or ≥60% (≥65 years)."|Day 22|Analysis was done on the PPS1 for HI Titer ≥1:40 at day 22 and PPS2 for Seroconversion|||Percentages of subjects||95% Confidence Interval|Number
1345312|NCT01867021|Primary|Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years|"Non-Inferiority was measured as the percentages of subjects who achieved seroconversion in HI titers three weeks (day 22) after vaccination of TIV compared with TIVf, against each of three vaccine strains.~Seroconversion is defined as a prevaccination titer <10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer.~The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%."|Day 22|Analysis was done on the PPS2, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at visit 1 and visit 2; and had no major protocol violations as defined prior to analysis|||percentages of subjects||95% Confidence Interval|Number
1345313|NCT01867021|Primary|Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years|"Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV (Trivalent Subunit Inactivated Influenza Vaccine) Group Over the Corresponding TIVf Group for All Three Strains, three weeks after vaccination (day 22).~The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5."|Day 22|Analysis was done on the per-protocol set 1 (PPS1) , ie, the subjects who received the vaccine correctly; provided evaluable serum samples at visit 2; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1345314|NCT01866943|Secondary|Harris Hip Scores|Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.|6 week|Patients undergoing primary total hip arthroplasty.|||units on a scale||Standard Deviation|Mean
1345315|NCT01866943|Secondary|Harris Hip Scores|Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.|2 week|Patients undergoing primary total hip arthroplasty.|||units on a scale||Standard Deviation|Mean
1345316|NCT01866943|Secondary|Harris Hip Scores|Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.|Preoperative|Patients undergoing primary total hip arthroplasty.|||units on a scale||Standard Deviation|Mean
1345317|NCT01866943|Secondary|Mid Thigh Circumference|Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.|Pre Op|Patients undergoing primary unilateral THA.|||centimeters||Standard Deviation|Mean
1345318|NCT01866943|Primary|Estimated Blood Loss|Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.|Pre Op, Post Op Day 2|Patients undergoing primary unilateral THA. Group membership is unknown as only data available is blinded and de-identified.|||Hemoglobin (grams/deciliter)||Standard Deviation|Mean
1345319|NCT01866709|Secondary|Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS.||First 48 hours|Study was prematurely terminated for safety reasons; no statistical analyses were conducted.||||||
1345320|NCT01866709|Primary|Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events.|To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline.|First 48 hours|Study prematurely terminated for safety reasons; no statistical analyses were conducted.||||||
1345321|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes - International Physical Activity Questionnaire (IPAQ)|"IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.~Per Office of Disease Prevention and Health Promotion's Physical Activity Guidelines:~A range of 500 to 1,000 MET-minutes of activity per week provides substantial [health] benefit, and amounts of activity above this range have even more benefit. Amounts of activity below this range also have some benefit. The dose-response relationship continues even within the range of 500 to 1,000 MET-minutes, in that the health benefits of 1,000 MET-minutes per week are greater than those of 500 MET-minutes per week.~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||MET-minutes per week||95% Confidence Interval|Mean
1345807|NCT01856907|Secondary|Mean Blood Glucose Level From the Oral Glucose Tolerance Test (OGTT)|The mean blood glucose is calculated by averaging the 4 blood glucose levels measure during a 75 gm oral glucose tolerance test . This involves summing the glucose levels measured at baseline, and 1/2 hour,1 hour and 2 hours after the glucose load and dividing by 4..|16 weeks||||mg/dL||Standard Deviation|Mean
1345322|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes - MEDFICTS Dietary Assessment|"Patient reported dietary outcomes will be assessed using MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument. This assessment looks at eight different categories of foods and assigns points by type of food and serving size ranging from 0 points (do not consume that food group) to 21 points (consume food group, largest serving size). Your final score is the total of all points for all food categories.~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||units on a scale||95% Confidence Interval|Mean
1345323|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes - Dermatology Life Quality Index (DLQI)|"The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||units on a scale||95% Confidence Interval|Mean
1345324|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes-EuroQol EQ-5D|EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient’s self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.|52 weeks (continuation group) or 64 weeks (crossover group)||||units on a scale||95% Confidence Interval|Mean
1345325|NCT01866592|Secondary|Safety/Adverse Events|Safety will be assessed by evaluating all subject reported adverse events through the duration of the study.|Baseline - Week 52||||Participants|||Count of Participants
1345326|NCT01866592|Secondary|Psoriasis Activity (PASI and PGA)|"Change in psoriasis activity will be assessed using the following standardized measurement tools for psoriasis: Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). PASI combines the assessment of the severity of lesions and the area affected into a single score with range 0 (no disease) to 72 maximal disease. The PGA is an average assessment of all psoriatic lesions based on erythema, scale, and induration with score range 0 (no disease/clear) to 5 (maximal disease).~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||Participants|||Count of Participants
1345327|NCT01866592|Primary|Change in Cardiometabolic Biomarker - GlycA|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
1345328|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Interleukin 6|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
1345329|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
1345330|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log C-reactive Protein|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
1345331|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Leptin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
1345332|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Adiponectin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin|52 weeks of adalimumab treatment||||log(ug/mL)||Standard Error|Mean
1345333|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Insulin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
1345334|NCT01866592|Primary|Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle|52 weeks of adalimumab treatment||||umol/L||Standard Error|Mean
1345335|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle|52 weeks of adalimumab treatment||||nmol/L||Standard Error|Mean
1345336|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Cholesterol Efflux|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Cholesterol Efflux|52 weeks of adalimumab treatment||||no units||Standard Error|Mean
1345808|NCT01856907|Secondary|Fasting Blood Glucose|Blood glucose in the fasting state|16 weeks||||mg/dL||Standard Deviation|Mean
1345338|NCT01866592|Primary|Change in Cardiometabolic Biomarker - GlycA|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
1345339|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Interleukin 6|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6 If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
1345340|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
1345341|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log C-reactive Protein|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
1345342|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Leptin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
1345343|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Adiponectin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(ug/mL)||Standard Error|Mean
1345344|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Insulin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
1345345|NCT01866592|Primary|Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||nmol/L||Standard Error|Mean
1345346|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||nmol/L||Standard Error|Mean
1345347|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Cholesterol Efflux|"The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||no units||Standard Error|Mean
1345348|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Total Cholesterol|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Total Cholesterol. If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||mg/dL||Standard Error|Mean
1345349|NCT01866592|Primary|Change in Vascular Inflammation|Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and start of adalimumab.The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR).|52 weeks of adalimumab treatment||||percentage change||95% Confidence Interval|Number
1345350|NCT01866592|Primary|Change in Vascular Inflammation|Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and baseline scans (prior to randomization in the VIP Trial). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR). If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||percentage change||95% Confidence Interval|Number
1345351|NCT01866423|Secondary|Number of Participants With Grade 3 or Higher Toxicity|Summary of grade 3 (per Common Terminology Criteria for Adverse Events (CTCAE v4.0) or higher toxicities which generally is described as a severe reaction or symptom.|30 days|Tracked during treatment period until 30 days after last dose of study drug.|||Participants|||Count of Participants
1345352|NCT01866423|Secondary|Duration of Response Using RECIST Version 1.1 and PCWG2 Criteria|Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.|Up to 3 years|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
1345353|NCT01866423|Secondary|Overall Response Rate Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and PCWG2 Criteria|Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.|Up to 3 years|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
1345354|NCT01866423|Secondary|Absolute Change in PSA|Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.|Baseline to 24 weeks|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
1345355|NCT01866423|Secondary|Best PSA Response|Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.|Up to 24 weeks|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
1345356|NCT01866423|Primary|PSA Response, Defined as Occurrence of PSA Decline to Greater Than or Equal to 50% From Baseline|Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.|At 12 weeks|Only 4 patients were accrued to this trial. No data analysis was performed.||||||
1345357|NCT01866423|Primary|Androgen Receptor (AR) Protein Expression Levels in CTCs|The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.|Up to 4 weeks|Only 4 patients were accrued to this trial. No data analysis was performed.||||||
1345358|NCT01866319|Secondary|Overall Response Rate (ORR)|"ORR was defined as the percentage of the participants with a best tumor response of complete response (CR) or partial response (PR) based on blinded independent central radiologic and clinical review using RECIST 1.1. CR was defined as disappearance of all target lesions with any pathological lymph nodes having a reduction in short axis to <10 mm. PR was defined as a 30% or greater decrease in the sum of diameters of target lesions.~Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants randomized to a study arm; data collected through 3 September 2014.|||Percentage of Participants||95% Confidence Interval|Number
1345359|NCT01866319|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. The reported percentage is estimated using a product-limit (Kaplan-Meier) method for censored data; for participants whose survival data was obtained after the data cut-off date for the interim analysis, data were censored at the date of cut-off (3 March 2015). Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).|Month 12|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 March 2015.|||Percentage of participants||95% Confidence Interval|Number
1345360|NCT01866319|Primary|Progression-free Survival (PFS)|"PFS was defined as the time from randomization to the first documented disease progression, based on blinded independent central radiologic and clinical review using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5mm or the appearance of new lesions.~Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 September 2014.|||Months||95% Confidence Interval|Median
1345368|NCT01866306|Primary|Number of Participants With Serious Adverse Events (SAE) (Parts 1 and 2)|A SAE is any adverse event occurring at any dose or during any use of the Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing in-patient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Day 24|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.|||Participants|||Number
1345441|NCT01863667|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54|This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
1345361|NCT01866306|Secondary|Mean Change From Baseline in TWA Asthma Control Diary (ACD) Score of Asthmatic Participants on Days 3 to 10 (Part 2)|The ACD contains seven symptom questions (nocturnal awakening, waking in the morning with symptoms, activity limitation, shortness of breath and wheezing) which are answered on rising in the morning and retiring at bedtime. Missing scores are imputed by linear interpolation or extrapolation. Daily ACD score was fit by a Bayesian hierarchical longitudinal model with participant-specific intercept and a fixed categorical effect for day. All baseline (day -7 to day -1) ACD scores are assumed to be with equal mean. The ACD score is the sum of responses to the seven questions, with answers on a 7-point scale (0= no impairment; 6 = maximum impairment) with the score ranging from 0 to 42, and higher scores indicating greater impairment. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent increase is anticipated to be different from zero.|Baseline and Days 3 to 10|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.|||Score on a scale||95% Confidence Interval|Mean
1345362|NCT01866306|Secondary|Mean Percent Change From Baseline in Maximum Drop FEV1 of Asthmatic Participants (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The percent decrease of the lowest FEV1 measurement after viral challenge compared to the TWA of the baseline FEV1 is presented. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent decrease is anticipated to be different from zero.|Baseline and up to day 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.|||Percent change||95% Confidence Interval|Mean
1345363|NCT01866306|Primary|Number of Asthmatic Participants Demonstrating at Least 10^3 Copies/ml of Viral RNA in Nasal Lavage Fluid on Days 1 to 14 (Part 1)|Viral RNA was measured by real time reverse transcriptase polymerase chain reaction (qRT-PCR) from nasal lavage fluid collected on day 3 and day 7 from asthmatic participants, and the number of participants with at least 10^3 copies/ml was determined.|Days 1 - 14|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed.|||Participants|||Number
1345364|NCT01866306|Primary|Change From Baseline in Mean Maximum Jackson Cold Symptom Score (CSS) on Days 1 to 14 in Asthmatic Participants (Part 1)|Asthmatic participants from Part 1 were treated with RV16UB virus, and challenge induced upper airway symptoms were monitored with a diary recording CSS. The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity, and a positive change from baseline indicating worsening symptoms.|Baseline and Days 1 - 14|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed.|||Score on a scale||Standard Deviation|Mean
1345365|NCT01866306|Primary|TWA Percent CFB in Evening FEV1 in Asthmatic Participants on Days 1-7 (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 pm to next day 3 am were counted as evening measurements. The TWA CFB evening FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 evening FEV1 value and the corresponding estimated baseline value. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.|Baseline and Days 1- 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.|||Percent change||95% Confidence Interval|Mean
1345366|NCT01866306|Primary|Time -Weighted Average (TWA) Percent Change From Baseline (CFB) in Morning FEV1 in Asthmatic Participants on Days 1-7 (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 am to 3 pm were counted as morning measurements. The TWA CFB morning FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 morning FEV1 value and the corresponding estimated baseline value. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.|Baseline and Days 1 - 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID50, was included in the analysis.|||Percent change||95% Confidence Interval|Mean
1345367|NCT01866306|Primary|Number of Asthmatic Participants Treated With a Viral Dose of 100 TCID50 With Challenge Induced Upper Airway Symptoms (Part 1)|Asthmatic participants from Part 1 were treated with RV16UB virus at a dose of 100 TCID50, and challenge induced upper airway symptoms were monitored with a diary recording Jackson Cold Symptom Score (CSS). The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity. The number of participants with a CSS score equal or greater than 3 for two days in a row are presented.|Day 1 up to Day 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, asthmatics treated with a viral dose of 10 TCID 50, and participants from Part 2 were not analyzed.|||Participants|||Number
1345515|NCT01861301|Secondary|Incidence of Adverse Events, Graded Per NCI CTCAE Version 4|Grade 3 or higher AE of any type, regardless of attribution.|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
1345369|NCT01866306|Primary|Number of Healthy and Asthmatic Participants With Events of Clinical Interest (ECI) (Part 1)|ECI are selected non-serious and serious adverse events which include the following: an overdose of Sponsor's product; requirement for systemic steroids to treat asthma exacerbation related to virus challenge; acute reaction to virus challenge, confirmed through repeat measurement and when considered potentially associated with administration of virus; specified vital sign findings within 4hr of challenge; specified symptom findings within 24hr of challenge; >20% decrease in Forced Expiratory Volume in 1 second (FEV1) relative to baseline within 4hr of challenge; dyspnea associated with drop in FEV1 (within 4hr of challenge) that is unresponsive to a bronchodilator rescue agent within 20 minutes; Grade 2+ deviation from normal values of liver-related laboratory parameters at any time between challenge and day 14.|Up to Day 24|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 2 were not analyzed.|||Participants|||Number
1345370|NCT01866293|Secondary|Duration of Response (DOR)||1 year|9 participants are evaluable. 2 participants never started treatment.|||days||Full Range|Median
1345371|NCT01866293|Secondary|Time to Progression (TTP)||1 year|9 participants are evaluable. 2 participants never started treatment.|||days||Full Range|Median
1345372|NCT01866293|Secondary|Safety and Toxicity in This Patient Population|Safety assessments and toxicity grading will follow CTCAE Version 4 Grade|1 year||||Participants|||Count of Participants
1345373|NCT01866293|Secondary|Overall Response Rate|IMWG Criteria for Response, Progression and Relapse in Multiple Myeloma Patients|1 year|9 participants are evaluable. 2 participants never started treatment.|||Participants|||Count of Participants
1345374|NCT01866293|Primary|Maximally Tolerated Dose|This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.|1 year|9 participants are evaluable. 2 participants never started treatment.|||mg|||Number
1345375|NCT01866163|Secondary|m-PASI at Week 1|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).~m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.~The m-PASI score range from 0 (best) to 64.8 (worst)."|1 week|All randomised subjects were included in the full analysis set and analysed for efficacy.|||Scores on a scale||95% Confidence Interval|Mean
1345376|NCT01866163|Secondary|m-PASI at Week 4|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).~m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.~The m-PASI score range from 0 (best) to 64.8 (worst)."|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.|||Scores on a scale||95% Confidence Interval|Mean
1345377|NCT01866163|Primary|Treatment Success According to IGA|"Subjects with ‘treatment success’ (‘clear’ or ‘almost clear’ for subjects with at least moderate disease at baseline, ‘clear’ for subjects with mild disease at baseline) according to the Investigators’ global assessment of disease severity (IGA) at Week 4.~The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe"|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.|||percentage of subjects|||Number
1345378|NCT01866150|Secondary|Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment|The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.|||swollen joints||Standard Deviation|Mean
1345379|NCT01866150|Secondary|Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.|||tender joints||Standard Deviation|Mean
1345380|NCT01866150|Secondary|Average Methotrexate Dose of Participants on Biological Combination Treatment||Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Participants in biologic combination group from All Participants Entered Analysis Set. Number of participants analyzed=participants with available data for methotrexate dose.|||milligrams per week||Standard Deviation|Mean
1345381|NCT01866150|Secondary|Duration of Treatment|Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.|Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data for duration of treatment.|||months||Standard Deviation|Mean
1345674|NCT01859247|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).|Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment||||units on a scale||Standard Deviation|Mean
1345382|NCT01866150|Secondary|Percentage of Participants by Category of DAS28 Score and Timepoint|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for the endpoint. Here, 'n' signifies number of participants with available data for specifies category.|||percentage of participants|||Number
1345383|NCT01866150|Secondary|Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.|||units on a scale||Standard Error|Mean
1345384|NCT01866150|Secondary|Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6. LDA was defined as a DAS28 score <3.2.|Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
1345385|NCT01866150|Secondary|Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 * √ of TJC) + (0.28 * √ of SJC) + (0.70 * ln ESR in mm/h) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score < 2.6.|Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
1345386|NCT01866150|Primary|Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.|Month 6|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR at Month 6.|||percentage of participants|||Number
1345387|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Concentration||Baseline, Week 8||||umol/L||95% Confidence Interval|Least Squares Mean
1345388|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Size||Baseline, Week 8||||nm||95% Confidence Interval|Least Squares Mean
1345389|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Concentration||Baseline, Week 8||||mmol/L||95% Confidence Interval|Least Squares Mean
1345390|NCT01865747|Secondary|Objective Response Rate (ORR)|Objective Response Rate (ORR) is the number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. ORR was assessed by the Independent Radiology Committee (IRC) per RECIST 1.1 which was confirmed by a subsequent visit >= 28 days later, and was analyzed in the Intent to Treat (ITT) population at the time of the primary analysis of Progression Free Survival (PFS). The data cutoff date was 22 May 2015.|ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months)|The analysis of ORR was performed in the ITT population (all randomized: 330 cabozantinib, 328 everolimus) based upon response determined by Independent Radiology Committee (IRC) per RECIST 1.1.|||percentage of participants|||Number
1345675|NCT01859195|Other Pre-specified|Number of Participants: Drug Delivery Systems Evaluations|Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development|1 year||||Participants|||Count of Participants
1345391|NCT01865747|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).|OS was measured from the time of randomization until 320 deaths, approximately 28 months|The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.|||months||95% Confidence Interval|Number
1345392|NCT01865747|Primary|Progression-free Survival (PFS)|The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.|PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.|The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).|||months||95% Confidence Interval|Number
1345393|NCT01865708|Secondary|Urine Analysis|"An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour, for a total of 3 days.~A baseline urinalysis will be obtained prior to the first instillation of ethanol, looking for hematuria.~A urinalysis will be obtained approximately 1 hour after the lock is released. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-ethanol lock days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any ethanol lock."|Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.|Change in detectable red blood cells per high powered field in urinalysis. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.|||red blood cells per high powered field||Standard Deviation|Mean
1345394|NCT01865708|Primary|Blood Alcohol Level|An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour. Blood alcohol levels will be obtained every day, approximately 1 hour after ethanol lock release, for 3 days: at baseline, 1 day post catheter placement, 2 days post catheter placement, and 3 days post catheter placement. Number of participants with Blood Alcohol Levels exceeding 10 mg/100 ml on any study day was analyzed.|up to 3 days|Number of patients with detectable blood alcohol level, defined as >= 10 mg/dL.|||Participants|||Count of Participants
1345395|NCT01865084|Secondary|Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil|The data reported are population estimate and inter-patient variability.|Weeks 4, 12, 24 and 36: -1 Hour up to 24 Hours Postdose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1345396|NCT01865084|Secondary|Change From Baseline in Pediatric Outcomes Data Collection Instrument (PODCI) Scores|"PODCI includes a Global Functioning Scale and 5 core scales:Upper Extremity and Physical Function,Transfer/Basic Mobility, Sports/Physical Functioning, Pain/Comfort,and Happiness.The Global Functioning Scale is the mean of the mean scores from 4 of the 5 core scales (all except the happiness core scale).The following PODCI scores were prespecified in the protocol for analysis: Global Functioning, Upper Extremity and Physical Function,Transfer/Basic Mobility, and Sports/Physical Functioning. The Global Functioning Scale and each of the core scales were standardized so that a score of 0 represents a poor outcome/worse health, while 100 is the best possible outcome/best health (i.e., complete range of each score is 0 to 100, with higher scores representing better functioning). The LS mean (LSM) change from baseline,standard error was derived using MMRM with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline PODC scale as covariate."|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement. The reason the number of participants analyzed is significantly less than the total number of randomized participants is because PODCI was administered only in English.|||Units on a scale||Standard Error|Least Squares Mean
1345397|NCT01865084|Secondary|Time to Persistent 10% Worsening in Timed Function Tests (TFT)|"Time on study until the TFT becomes 10% worse than the baseline TFT and continues at that level or lower until the end of study. The time to persistent 10% worsening is the observed time after baseline until the first observed timepoint where their time used for the TFTs is >110% of the baseline time and all the time values observed afterward are also >110% of baseline. If the participant discontinues prior to experiencing persistent worsening, this outcome for the participant is censored at the date of discontinuation of the double-blind period.~Only participants with complete evaluable data were analyzed. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit."|Baseline through Week 48|All randomized participants who received at least 1 dose of study drug who had complete evaluable data.Censored participants:Rise from Floor;placebo(pl)=40,0.3 mg/kg=39,0.6 mg/kg=43;Stair Climb;pl=55,0.3 mg/kg=45,0.6 mg/kg=52;10 Meter Walk/Run pl=61,0.3 mg/kg=65,0.6 mg/kg=58,Stair Descend;pl=63,0.3 mg/kg=60,0.6 mg/kg=59.|||Days||95% Confidence Interval|Median
1345398|NCT01865084|Secondary|Time to Persistent 10% Worsening in 6MWD|Time on study until the 6MWD becomes 10% less than the baseline 6MWD and continues at that level or lower until the end of study.|Baseline through Week 48|All randomized participants who received at least one dose of study drug who had complete evaluable data. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit. Censored participants: placebo=71, 0.3 mg/kg=63, 0.6 mg/kg=61.|||Days||95% Confidence Interval|Median
1345439|NCT01863667|Secondary|Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment|Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
1345399|NCT01865084|Secondary|Change From Baseline in Timed Function Tests in Seconds|Timed function tests included time it took to rise from floor, walk 10 meters, ascend 4 stairs, and descend 4 stairs.The lower the time in seconds taken, the better the performance. The LS mean change from baseline, standard error, was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.|||Seconds||Standard Error|Least Squares Mean
1345400|NCT01865084|Secondary|Change From Baseline in the North Star Ambulatory Assessment (NSAA) Global Score|The NSAA is a functional scale specifically designed for ambulant boys with DMD that can provide additional information on motor functions important in maintaining normal ambulation and other activities important to everyday life. The NSAA is a 17-item evaluation of standing, ability to transition from lying to sitting, sitting to standing, and other mobility assessments. Each of the 17 items is evaluated on an ordinal scale of 0, 1, or 2, with higher scores reflecting better performance on the assessment, for a total maximum score of 34. This score was transformed to a 0 to 100 scale for the key analysis (referred to as linearized), with higher transformed scores reflecting better performance.The LS mean (LSM) change from baseline standard error was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.|||Units on a scale||Standard Error|Least Squares Mean
1345401|NCT01865084|Primary|Change From Baseline in Six Minute Walk Distance (6MWD) in Meters|"6MWD measured the distance in meters a participant was able to walk in 6 minutes. The study used 6MWD procedure modified specifically for use in boys with Duchenne muscular dystrophy (DMD), including standardized verbal encouragement at specific intervals to maintain attention to the test, and use of a safety chaser to walk behind the participant during testing (McDonald et al., 2010a). The LS mean (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline 6MWD as a covariate."|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.|||Meters||Standard Error|Least Squares Mean
1345402|NCT01864538|Primary|Overall Survival||1 year||||Participants|||Count of Participants
1345403|NCT01864525|Secondary|Auditory-perceptual Tremor Severity Ratings|Three experienced listeners independently rated each participant's voice from paired sample recordings comparing the baseline to post-test samples in randomized order for each condition. Sustained vowel and sentence-level recordings were rated, with decoded samples later analyzed for 1=better for post-test compared to baseline, 0= no difference between post-test and baseline. Maximum score for each participant was 3 (post-test was better for each of three raters). The range of possible scores was the sum of each of three raters' scores (0 to 3), with 0 indicating no difference between baseline and post-test voice tremor severity rating, and 3 indicating better voice (less tremor severity) at post-testing compared to pre-testing. Mean post-test values for task were compared for the octanoic acid and placebo conditions, and all raters were blind to which sample was a baseline versus a post-test recording, and which samples were associated with the [placebo or octanoic acid conditions.|Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2).||||units on a scale||Standard Deviation|Mean
1345404|NCT01864525|Primary|Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor|Voice recordings were used to measure the degree of tremor in the voice. Mean post-test values for each acoustic measure were compared after the octanoic acid and placebo conditions, with and without consideration of baseline values. Mean values represent the average of two testing days. Degree of amplitude tremor shows the extent of amplitude variation as a percent of the mean signal amplitude, with lower numbers indicating less amplitude tremor. Baseline values for magnitude of amplitude tremor across all participants and conditions ranged from 4.06 to 27.09, and post-test values ranged from 1.94 to 26.02. Degree of frequency tremor shows the extent of fundamental frequency variation as a percent of the mean signal frequency, with lower numbers indicating less frequency tremor. Baseline values for magnitude of frequency tremor across all participants and conditions ranged from 1.21 to 15.31, and post-test values ranged from 0.60 to 13.86.|Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2)||||percentage of voice signal with tremor||Standard Deviation|Mean
1345405|NCT01864434|Primary|Kinematics - Ramp Down Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity|3 months post-operative||||mm||Standard Deviation|Mean
1345406|NCT01864434|Primary|Kinematics - Ramp up Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity|3 months post-operative||||mm||Standard Deviation|Mean
1345407|NCT01864434|Primary|Kinematics - Deep Knee Bend Activity|Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity|3 months post-operative||||mm||Standard Deviation|Mean
1345408|NCT01864200|Primary|Patient Specific Functional Scale Score|"Patient Specific Functional Scale (PSFS) at 14 day follow-up This is a three-item instrument, administered verbally, that is used to evaluate whether a health condition impacts a patient's ability to perform activities that are important to him/her. On the initial assessment, the patient is asked to identify up to three important activities that you are unable to do or are having difficulty with as a result of your (snakebite). The patient then provides a rating for each item, on an 11-point ordinal scale ranging from 0 (unable to perform activity) to 10 (able to perform activity at the same level as before the injury or problem). During reassessments, the subject is prompted to re-rate the same three activities. The average of up to 3 specific activity scores was recorded, and the range of possible scores is 0 - 10. Higher scores indicate less impairment."|at 14 day follow-up||||units on a scale||Standard Error|Mean
1345409|NCT01864174|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.|Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)|Treated participants; All participants who took at least one dose of double-blind study medication in the treatment group they were randomized to unless participants had never received the double-blind study medication they were randomized. Those participants were included in the treatment group based on the first treatment received.|||participants|||Number
1345410|NCT01864174|Secondary|Percent of Participants With HbA1c < 7%|Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.|Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.|||percent of participants||95% Confidence Interval|Number
1345411|NCT01864174|Secondary|Mean Change in Mean Daily Glucose (MDG)|The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG.|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 last observation carried forward (LOCF) results who were not excluded due to non-compliance.|||mg/dL||Standard Error|Mean
1345412|NCT01864174|Secondary|Mean Change in Fasting Plasma Glucose (FPG)|The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG > 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values and who were not excluded due to non-compliance.|||mg/dL||Standard Error|Mean
1345413|NCT01864174|Primary|Adjusted Mean Change From Baseline in HbA1c|Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.|||percent||Standard Error|Mean
1345414|NCT01864148|Secondary|Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84||Up to 84 weeks|PK Population: participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data point on record.|||µg/mL||Standard Deviation|Mean
1345415|NCT01864148|Secondary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.|Up to 84 weeks|Safety Population: all participants who received at least 1 dose of study treatment.|||participants|||Number
1345416|NCT01864148|Secondary|Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint|Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.|72 weeks|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).|||proportion of participants|||Number
1345438|NCT01863667|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia|An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.||||||
1345417|NCT01864148|Primary|Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint|Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.|72 weeks|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).|||proportion of participants|||Number
1345418|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 6 weeks after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
1345419|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 24 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
1345420|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 8 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
1345421|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 0.5 hour after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
1345422|NCT01864005|Primary|the Percentage Inhibition of the P2Y12 Receptor|Note: the primary endpoint was changed per the statistical analysis plan prior database lock.|at 2 hours after first dose of study drug|FAS (full analysis set). Three randomized patients were excluded from FAS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
1345423|NCT01863953|Secondary|Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.|Day 14, Day 28, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment|||mmHg||Standard Deviation|Mean
1345424|NCT01863953|Secondary|Change From Baseline in Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14, Day 28|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment|||mmHg||Standard Deviation|Mean
1345425|NCT01863953|Primary|Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1345426|NCT01863771|Secondary|Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54|Mucosal healing is defined as an endoscopy subscore of 0 or 1, where 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern, mild friability). Endoscopy subscore is one of the 4 subscores of the Mayo score.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.|||participants|||Number
1345427|NCT01863771|Secondary|Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54|Clinical remission (as measured by the Mayo score) was defined as a Mayo score of less than or equal to (<=) 2 points, with no individual sub-score greater than (>) 1.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.|||participants|||Number
1345440|NCT01863667|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment|Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
1345428|NCT01863771|Primary|Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score|Clinical response was defined as a decrease from Induction-Week 0 in the Mayo score by greater than or equal to (>=) 30 percent and >=3 points, with a decrease in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.|Up to Week 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.|||participants|||Number
1345429|NCT01863758|Secondary|Dosage Per Week in Phase II|The mean dosage per week during Phase II of the study are reported.|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||IU/kg||Standard Deviation|Mean
1345430|NCT01863758|Secondary|Median Dosing Interval During Individually Tailored Prophylaxis|The median time between 2 prophylactic doses of Human-cl rhFVIII in the prophylactic treatment phase II were determined per patient|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||Hours||Inter-Quartile Range|Median
1345431|NCT01863758|Secondary|Annualized Number of Bleeding Episodes (BE) in Phase II in Participants With ≤ 2 Treatments/Week|The annualized number of BEs was calculated for each participant as follows: d*y/t, where y = the number of BEs documented in Phase II, t = the number of treatment periods in days, and d = 365.25, the number of days per year. A bleeding episode (BE) was defined as a BE whether treated or not during Phase II of the study. BEs related to surgery were not included.|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII. Only participants who received ≤ 2 treatments/week were included in the analysis.|||Annualized number of bleeding episodes||Standard Deviation|Mean
1345432|NCT01863758|Secondary|Annualized Number of Spontaneous Bleeding Episodes (BE) in Phase II|The annualized number of spontaneous BEs was calculated for each participant as follows: d*y/t, where y = the number of spontaneous BEs documented in Phase II, t = the number of treatment periods in days, and d = 365.25, the number of days per year. A spontaneous bleeding episode (BE) was defined as a BE whether treated or not during Phase II of the study. BEs related to surgery and BEs due to trauma or due to other causes were not included.|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||Annualized number of bleeding episodes||Standard Deviation|Mean
1345433|NCT01863758|Primary|Annualized Number of Bleeding Episodes (BE) in Phase II|The annualized number of total BEs was calculated for each participant as follows: d*y/t, where y = the number of BEs documented in Phase II, t = the number of treatment periods in days, and d = 365.25, the number of days per year. A bleeding episode (BE) was defined as any BE whether treated or not during Phase II of the study; BEs related to surgery were not included. This study was considered as showing efficacy if the annualized number of BEs was reduced by 50% compared to the number of BEs observed in study GENA-01 where patient where severe Hemophilia A patients were treated on-demand (NCT00989196).|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||Annualized number of bleeding episodes||Standard Deviation|Mean
1345434|NCT01863680|Secondary|Serum Progesterone Level|Two pharmacokinetic (PK) samples were collected per subject for the measurement of serum progesterone concentrations; 1st sample at Visit 2-2 (prior to hCG administration) and second sample during Visit 5 (Day 14+/-3, 7 hours after the morning of investigational medicinal product administration).|Visit 2-2 (Prior to hCG administration) and Visit 5 (Day 14+/-3)|"The PK analysis set included all subjects who had serum beta-hCG pregnancy test performed at Visit 5 (Day 14+/-3), who had two progesterone concentrations at Visit 2-2 and Visit 5, and who had no relevant problems for compliance of administration until Visit 5. n signifies the number of subjects who were evaluable in each category, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1345435|NCT01863680|Secondary|Biochemical Pregnancy Rate Per Embryo Transfer|Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS during Visit 6 (Week 5), but with a positive serum beta-hCG pregnancy test result at Visit 5 (Day 14+/-3). Biochemical pregnancy rate was calculated as the number of subjects who had no fetal sac observed during Visit 6 (Week 5) TVUS assessment or subjects who had a positive serum pregnancy test at Visit 5 (Day 14+/-3) and no data recorded at Visit 6 (Week 5) divided by the number of subjects who has at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.|||Percentage of pregnancy/embryo transfer|||Number
1345436|NCT01863680|Primary|Clinical Pregnancy Rate Per Embryo Transfer|Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.|||Percentage of pregnancy/embryo transfer|||Number
1345437|NCT01863667|Secondary|Change From Baseline in Body Weight at Week 54|Body weight was to be measured (in duplicate) using a calibrated digital scale.|Baseline and Week 54|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54.||||||
1345442|NCT01863667|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.|||Percentage of participants|||Number
1345443|NCT01863667|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 57 weeks (including 3 weeks following the last dose of study drug)|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.|||Percentage of participants|||Number
1345444|NCT01863667|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 54|A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
1345445|NCT01863563|Primary|Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds|After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.|at the time of surgery, 1 hour||||seconds||Standard Deviation|Mean
1345446|NCT01863433|Secondary|Type and Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
1345447|NCT01863433|Secondary|Type and Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
1345448|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
1345449|NCT01863433|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||fold increase||Standard Deviation|Geometric Mean
1345450|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
1345451|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.|||units on a scale||Standard Deviation|Mean
1345452|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.|||units on a scale||Standard Deviation|Mean
1345453|NCT01863368|Secondary|Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)|The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.|||units on a scale||Standard Deviation|Mean
1345454|NCT01863368|Primary|Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)|The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.|Baseline, Day 35|This analysis group includes all randomized subjects with data at visit.|||units on a scale||Standard Deviation|Mean
1345455|NCT01863134|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE)|MACCE was defined as combined death, nonfatal myocardial infarction, cerebrovascular event (stroke) and the need for re-hospitalization due to recurrent ischemia up to 12 months follow-up|Up to 12 month||||Percentage of study group|||Number
1345456|NCT01862991|Secondary|Adverse Events|Uterine perforation|Intraoperatively and 2 weeks post operatively||||Participants|||Count of Participants
1345457|NCT01862991|Primary|Procedure Time|Measured as time from speculum insertion to removal|Intraoperative Time, Collected immediately within procedure||||minutes||Full Range|Median
1345458|NCT01862874|Secondary|Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease|Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.|Up to Month 36|Participants who were seronegative at Day 1 and PCR negative from Day 1 through Month 7 to the relevant HPV type, received all 3 vaccinations, did not deviate from the study protocol in ways that might interfere with vaccine efficacy, and had ≥1 follow-up visit after Month 7.|||Cases per 100 person-years at risk|Person-years follow-up||Number
1345459|NCT01862874|Primary|Percentage of Participants With a Vaccine-related Systemic Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.|Up to 15 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
1345460|NCT01862874|Primary|Percentage of Participants With a Systemic Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.|Up to 15 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
1345461|NCT01862874|Primary|Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.|Up to 5 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
1345462|NCT01862874|Primary|Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card|Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.|Up to 5 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
1345463|NCT01862874|Primary|Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection|Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.|Up to Month 36|Participants who were seronegative at Day 1 and PCR negative from Day 1 through Month 7 to the relevant HPV type, received all 3 vaccinations, did not deviate from the study protocol in ways that might interfere with vaccine efficacy, and had ≥1 follow-up visit after Month 7.|||Cases per 100 person-years of follow-up|Person-years follow-up||Number
1345464|NCT01862484|Primary|ADHD Rating Scale IV|The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998.|5 weeks|Children with ADHD who completed the five week diet and parents filled out the ADHD rating scale.|||units on a scale||Standard Deviation|Mean
1345465|NCT01862419|Primary|Relative Maximum Change in Creatinine||7 days of randomization||||relative percent change||Inter-Quartile Range|Median
1345466|NCT01862419|Primary|Death||7 days of randomization||||participants|||Number
1345467|NCT01862419|Primary|Dialysis Within 7 Days|This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis.|From start of AKI to 7 days later||||participants|||Number
1345468|NCT01862250|Secondary|Time to Passive Rewarming|Following 2 hours of therapeutic hypothermia, the temperature of the thermo-blanket is adjusted up half degree per hour allowing passive rewarming until 36.5 degrees is reached|Beginning at 72 hours up to 12 hours||||Hours||Inter-Quartile Range|Median
1345469|NCT01862250|Secondary|Presence of Shivering After Clonidine|Babies were assessed after administration of clonidine for the presence or absence of shivering.|48hrs||||Participants|||Count of Participants
1345470|NCT01862250|Primary|Amount of Morphine Given|Intravenous morphine (mg/kg) was given. The standard dose is 0.05 mg/kg per dose|Up to 2 days||||mg/kg||Inter-Quartile Range|Median
1345471|NCT01862250|Primary|Steady State Clonidine Blood Levels During Hypothermia|"Trough clonidine blood levels were measured after 4-7 doses of clonidine were given intravenously with a dosing interval of every 8 hrs. Mean and standard deviation (SD) of the number of doses given prior to levels being drawn was 5.3 (mean) and 0.37 (SD).~Time after last dose before measurement was 9hrs (mean) and 2.7hrs (SD)."|3 days|Only 8 babies were assessed for this outcome because the rest did not have a steady state trough level performed during cooling|||ng/ml||Full Range|Median
1345472|NCT01862159|Secondary|Specific Postoperative Complications|Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)|30 days or the postoperative hospital stay if longer than 30 days||||Participants|||Count of Participants
1345473|NCT01862159|Secondary|Length of Stay|Length of stay after the primary operation|30 days or the postoperative hospital stay if longer than 30 days||||days||Standard Deviation|Mean
1345474|NCT01862159|Secondary|Operating Time|length of the operation|operation||||minutes||Standard Deviation|Mean
1345475|NCT01862159|Primary|Serious Complications|Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)|30 days or the postoperative hospital stay if longer than 30 days|All patients operated after Jan 1, 2010|||Participants|||Count of Participants
1345476|NCT01862133|Primary|Providers' Opinion of Patients' Controlling EHR Access|"Percent of providers answering Strongly Agree or Agree to the following question on the post-study survey: I think it is OK for patients to have control over who sees what information in their electronic health records."|6 month study|||||||
1345477|NCT01862133|Primary|Number of Patients Recording Preferences to Restrict Provider Access to Some or All Electronic Health Record (EHR) Data|"Patients had to restrict access to either all data or one of five categories of sensitive data (sexually transmitted infections, HIV/AIDS, sexual health and pregnancy, drug and alcohol use and abuse, and mental health information) to one or more of the study providers."|6 month study|All patients recorded their preferences and completed the questionnaire. 24 (77%) of the 31 providers completed the anonymous post-study questionnaire.|||participants|||Number
1345478|NCT01861925|Post-Hoc|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Normalized Differences of Keratometry Axis Measurement Between Both Devices.|"For definition of keratometry axis see outcome measures 4 and 5.~This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of normalized difference and 95% confidence interval of mean normalized difference for axis of flat meridian.~Difference is normalized for each eye as function of astigmatism to a refractive error of 0.167 diopters (i.e. an axis difference of 1 normalized degree results in a refractive error of 0.167 diopter), to provide a measure which can be directly related to its impact on visual quality.~Please note that for this analysis a separation in arms normal eye and large regular astigmatism is not meaningful, thus here both groups are analyzed jointly as group regular eye"|1 day of examination||||normalized degree||95% Confidence Interval|Mean
1345479|NCT01861925|Other Pre-specified|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Axis Measurement Between Both Devices.|"Keratometry axis refers to the axis of the flat meridian of the toric representation of the cornea. For additional information see outcome 4.~This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of difference and 95% confidence interval of mean difference for axis of flat meridian."|1 day of examination||||degree||95% Confidence Interval|Mean
1345480|NCT01861925|Other Pre-specified|Equivalence of Keratometry Radius Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Radius Measurement Between Both Devices.|"Keratometry radius refers to the corneal curvature R (see primary measure outcome). In this context, the cornea is approximated by a toric surface which can be characterized by a flat meridian (radius R1) and a steep meridian (radius R2) with an angle of 90 degrees between these meridians.~This outcome measure aims at testing the equivalence of keratometry radius measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of difference and 95% confidence interval of mean difference for radius of flat meridian (R1) and radius of steep meridian (R2)."|1 day of examination||||micrometer||95% Confidence Interval|Mean
1345481|NCT01861925|Other Pre-specified|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Std. Dev. of Local Corneal Elevation Differences for One Measurement Per Device.|"For definition of corneal topography, areas of evaluation and methods, see outcome 1 and 2.~Corneal elevation refers to the distance between the measured corneal surface and the best fitting sphere, and is given in µm.~This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.~elevation difference (2 std. dev.) is the sample mean of twice the standard deviation of local corneal elevation differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination||||micrometer||95% Confidence Interval|Mean
1345482|NCT01861925|Secondary|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device.|"For definition of corneal topography, corneal power in diopter, areas of evaluation and methods, see outcome 1.~This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.~power difference (2 devices) is the sample mean and 95% C.I. of differences of spatial mean of corneal power between two devices. This value quantifies systematic differences between devices (e.g. calibration), ignoring local variations of the power measurement.~power difference (2 std.dev.) is the sample mean of twice the standard deviation of local power differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination||||diopters||95% Confidence Interval|Mean
1345483|NCT01861925|Primary|In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements|"Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. Diopter is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R.~Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination.~According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm<d<=6mm.~power difference (2 rep. meas.): sample mean and 95% C.I. of differences of spatial mean of corneal power between two consecutive measurements.~power difference 2 std.dev.: sample mean of twice the deviation of local power differences (two consecutive measurements)."|1 day of examination||||diopters||95% Confidence Interval|Mean
1345484|NCT01861756|Secondary|Glycemic Control (HbA1c)||3 and 6 months after patient initial encounter|||||||
1345485|NCT01861756|Secondary|Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records||3 and 6 months after patient initial encounter|||||||
1345486|NCT01861756|Secondary|Patient and Clinician Satisfaction With the Decision Making Process|"Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support.~Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient."|Day 1|||||||
1345487|NCT01861756|Secondary|Degree of Patient Knowledge About Available Treatment Alternatives|Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.|Day 1|||||||
1345488|NCT01861756|Primary|Overall Decisional Comfort (0-100, 100=no Conflict)|Quality of the decision making process assessed by means of the Decisional Conflict Scale|Day 1||||units on a scale||95% Confidence Interval|Mean
1345489|NCT01861704|Secondary|Gain, Speech Understanding and Sound Quality||During useful lifespan of device|||||||
1345490|NCT01861704|Secondary|Device Comfort||During useful lifespan of device|||||||
1345491|NCT01861704|Primary|Immediate Refit Upon Device Removal|Upon device removal, a qualified audiologist examined subjects’ ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.|Following device removal at the same appointment (Up to 24 hours after removal)|Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument|||percentage of ears|Participants|90% Confidence Interval|Number
1345492|NCT01861665|Primary|Wong-Baker Faces Pain Rating Scale|Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.|Post surgery day 0, post surgery day 1, post surgery day 2||||units on a scale||Standard Deviation|Mean
1345493|NCT01861587|Primary|Average Pain|To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0–10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline Only||||units on a scale||Standard Deviation|Mean
1345494|NCT01861587|Primary|Average Pain at Worst|To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0–10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline Only||||units on a scale||Standard Deviation|Mean
1345495|NCT01861587|Primary|Average Pain at Least|To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0–10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline and Discharge||||units on a scale||Standard Deviation|Mean
1345496|NCT01861587|Primary|Patient Controlled Analgesia (PCA) Hydromorphone Usage|The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.|Participants were followed for the duration of hospital stay, an average of 48 hours.||||milligrams of hydromorphone||Standard Deviation|Mean
1345497|NCT01861574|Primary|Affective Dimension of McGill Pain Questionnaire|"Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 & 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 & 4 occurred on Post-Op Day 2, 4 hours apart.~The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12.~The maximum total score for the Affective dimension is 12. Higher scores are indicative of worse pain on the affective dimension of pain."|Check Up 1, Check Up 2, Check Up 3, and Check Up 4||||units on a scale||Standard Error|Mean
1345498|NCT01861574|Secondary|Confidence Ratings of Guessing TMS Condition Assignment|"After participants guessed their TMS condition; whether they received real or sham TMS, They were then asked to rate the confidence in their guess. Ratings were on a scale of 0-10 where 0=complete guess and 10=absolutely sure.~Results below include the mean confidence ratings of those that guessed the TMS condition correctly and those that guessed incorrectly."|After Second TMS Treatment (Check up 4)||||units on a scale||Standard Deviation|Mean
1345499|NCT01861574|Secondary|Correctly Guessed Assignment Condition at 4 Hours|Participants were asked to guess whether they received real or sham TMS after each rTMS session. The results below report the percentage or participants that correctly guessed TMS Condition after the second TMS treatment, 4 hours after surgery.|After second TMS treatment (Check up 4)||||percentage of participants|||Number
1345500|NCT01861574|Primary|Sensory Dimension of McGill Pain Questionnaire|"Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 & 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 & 4 occurred on Post-Op Day 2, 4 hours apart.~The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12.~The range of scores for the sensory dimension of pain is 0-33. The maximum total score for the sensory dimension is 33.~Higher scores are indicative of worse pain on the sensory dimension of pain."|Check Up 1, Check Up 2, Check Up 3, and Check Up 4||||units on a scale||Standard Error|Mean
1345501|NCT01861574|Primary|Patient Controlled Analgesia (PCA) Hydromorphone Usage|PCA pump usage post-operatively was tracked 0-48 hours after surgery. The PCA pump usage was downloaded from the PCA pump after discharge from the hospital. The results reported below are averaged over Post-op hours 0-48 (total PCA pump usage post-operatively). The results include the mean PCA pump usage post-operatively for all groups (4).|Post-Op Hour 0 through 48||||"concentration in mg/ml"||Standard Deviation|Mean
1345502|NCT01861522|Secondary|Adverse Events and Adverse Drug Reactions||Week 2|||||||
1345503|NCT01861522|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||Randomization, Week1 and Week 2|||||||
1345504|NCT01861522|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||baseline, Week1 and Week 2|||||||
1345505|NCT01861522|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week1 and Week 2|||||||
1345506|NCT01861522|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||baseline, Week1 and Week 2|||||||
1345507|NCT01861522|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).|Baseline and Week 2||||units on a scale||Standard Error|Least Squares Mean
1345508|NCT01861457|Secondary|Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10 hour workday||||Percent change in colonization||Inter-Quartile Range|Median
1345509|NCT01861457|Primary|Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10-hour work day|All participants who received 3 scheduled treatments|||Percent change in colonization||Inter-Quartile Range|Median
1345510|NCT01861301|Other Pre-specified|Association Between Baseline HGF, MET Gene Amplification, MET IHC and PFS|Will be evaluated using the Cox regression model.|Baseline to 1 year|||||||
1345511|NCT01861301|Other Pre-specified|Change in Serum HGF or MET IHC and Tumor Size Change (Percent Reduction in Sum of Longest Diameters)|Will be evaluated by Spearman’s rank correlation coefficient.|Baseline to 1 year|||||||
1345512|NCT01861301|Other Pre-specified|Change in Baseline Levels of Continuous or Ordinal Markers (e.g., Serum HGF/MET IHC) Between Responders and Non-responders|Fisher’s exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar’s test will be used for binary markers.|Baseline to 1 year|||||||
1345513|NCT01861301|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Analyzed using the Kaplan-Meier method.|Up to 2 years||||Months||95% Confidence Interval|Median
1345514|NCT01861301|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method.|Up to 2 years||||Months||95% Confidence Interval|Median
1345516|NCT01861301|Primary|Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year|Note: Study terminated for futility due to insufficient number of objective responders in first stage.|||percentage of participants||95% Confidence Interval|Number
1345517|NCT01860989|Primary|28-day Cure Rate|28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).|Day 28|PharmacoDynamic (PD) Analysis Set - All the 11 patients were included in PD analysis set.|||Percentage of participants|||Number
1345518|NCT01860976|Secondary|Percentage of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline|Blood samples were collected at Days 1, 85 and 169 and assayed for the presence of abatacept-specific antibodies. The number of participants with at least one positive immunogenicity response was divided by the number of treated participants and expressed as a percentage.|Baseline to Day 169|All treated participants|||Percentage of participants|||Number
1345519|NCT01860976|Secondary|Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169|Adjusted mean change in scores on the Short Form 36 physical and mental function assessment (SF-36) from baseline were analyzed from the physical component summary (PCS) mental component summary (MCS). The SF-36 is a participant questionnaire assessing 8 domains of health status: physical functioning, pain, vitality, social functioning, psychological functioning, general health perception, and role limitations due to physical and emotional problems. The instrument can be divided into two summary scores, physical and mental component score. The scores range from 0 to 100, with a higher score indicating better quality of life. The two summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales.|Baseline to Day 169|All treated participants|||units on a scale||Standard Error|Mean
1345520|NCT01860976|Secondary|Percentage of ACR 50 and ACR 70 Responders at Day 169|The ACR 50 and ACR 70 definition of improvement is a 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 50% or 70% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 50 and ACR 70 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1345521|NCT01860976|Secondary|Percentage of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%|The number of participants who achieved at least 50% improvement from baseline in Psoriasis Area and Severity Index Arthritis (PASI 50) at Day 169 was divided by the number of treated participants with BSA >= 3% and expressed as a percentage. Only participants with >= 3% body surface area (BSA) of psoriatic skin involvement at randomization were included in this analysis.|Baseline to Day 169|All treated participants with >= 3% BSA of psoriatic skin involvement at randomization|||Percentage of participants||95% Confidence Interval|Number
1345522|NCT01860976|Secondary|Percentage of Non-progressors in Total PsA-modified SHS at Day 169|The number of radiographic non-progressors in total PsA-Modified Sharp van der Heijde score (SHS) at Day 169 was divided by the number of treated participants and expressed as a percentage. Non-progression was defined as a change from baseline in total PsA modified SHS ≤0. Early escape participants, and participants with missing data at day 169 were imputed as non-progressors.|Baseline to Day 169|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1345523|NCT01860976|Secondary|Percentage of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation|The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-exposed participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated TNFi-exposed participants|||Percentage of participants||95% Confidence Interval|Number
1345524|NCT01860976|Secondary|Percentage of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation|The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-naive participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated TNFi-naïve participants|||Percentage of participants||95% Confidence Interval|Number
1345525|NCT01860976|Secondary|Percentage of Health Assessment Questionnaire (HAQ) Responders at Day 169|Participants were considered responders if their HAQ score decreased at least 0.35 from baseline. The number of HAQ responders was divided by the number of treated participants and expressed as a percentage. Scoring conventions are based on the Standard Disability Index of HAQ/HAQ-DI using the 20 response items. For each of the 8 disability categories there is an “aids/devices” companion variable that is used to record the type of assistance, if any, a participant uses for his/her usual activities. If either “aids/devices” and/or “assistance from another person” are checked for a disability category, the score for this category is set to “2” (much difficulty), if the original score was “0” (no difficulty) or “1” (some difficulty). The HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Baseline to Day 169|All treated participants|||percentage of participants||95% Confidence Interval|Number
1345526|NCT01860976|Primary|Percentage of ACR 20 Responders at Day 169|The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1345527|NCT01860846|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence in a clinical investigation participant that met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks|All enrolled participants|||Participants|||Count of Participants
1345528|NCT01860846|Secondary|Change in Extra-intestinal Symptoms|Extra-intestinal manifestations of Crohn’s Disease (skeletal system [bones and muscle], dermatological [skin], hepatobiliary system [liver, gall bladder, and bile ducts], ocular [eyes] and oral [mouth]) were documented by the study investigators at each visit.|At baseline and 12 months|Participants with available data|||Participants|||Count of Participants
1345529|NCT01860846|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item self-administered questionnaire to measure health-related quality of life in adults with Crohn’s Disease. The 32 items are grouped into subscales: bowel-related symptoms (10 items), systemic symptoms (5 items), social function (5 items), and emotional function (12 items). Responses to each item within each subscale range from 1 (significant impairment) to 7 (no impairment), and mean scores ranging from 1 to 7 are calculated for each subscale. Higher scores indicate a better quality of life.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
1345530|NCT01860846|Secondary|Change in Short Form 36 (SF-36) Health Survey Scores|"The Short Form 36 (SF-36) Health Survey was used to determine participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item were summed and averaged (range = 0 worst to 100 best). Increases from baseline indicate improvement."|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
1345531|NCT01860846|Primary|Total Activity Impairment (TAI)|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn’s Disease. The self-administered questionnaire consisted of 6 questions. Question 6 asked participants to indicate the degree to which their health affected their regular activities in the past 7 days. Total activity impairment is the percent impairment of non-work related activities due to health problems and was calculated with the formula (Q6/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
1345532|NCT01860846|Primary|Total Work Productivity Impairment (TWPI)|The Work Productivity and Activity Impairment: General Health (WPAI:GH) self-administered questionnaire was used to assess impairments in work due to symptoms of Crohn’s Disease. Q2 asked participants the number of hours missed due to health problems in the past 7 days. Q4 asked participants the number of hours that they worked in the past 7 days. Q5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working). Total work productivity impairment (TWPI) is the combined absenteeism and presenteeism for employed participants, the percentage of overall work productivity lost due to health problems. TWPI was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))×(Q5/10)] × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
1345533|NCT01860846|Primary|Work Productivity and Activity Index (WPAI): Presenteeism|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn’s Disease. The self-administered questionnaire consisted of 6 questions. Question 5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 to 10, with 0 indicating that health problems had no effect on their work and 10 indicating that health problems completely prevented the participant from working. Presenteeism (impairment at work) was calculated by the formula (Q5/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
1345534|NCT01860846|Primary|Work Productivity and Activity Index (WPAI): Absenteeism|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn’s Disease. The self-administered questionnaire consisted of 6 questions. Question 2 asked participants to indicate the number of hours missed due to health problems in the past 7 days. Question 4 asked participants to indicate the number of hours that they worked in the past 7 days. Absenteeism (work time missed) was defined as the percentage of time absent from work due to health problems in the past week and was calculated by the formula Q2/(Q2 + Q4) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
1345689|NCT01858766|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1345535|NCT01860703|Secondary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||milliseconds||Standard Deviation|Least Squares Mean
1345536|NCT01860703|Primary|Maximum Change From Baseline (dQT/dQTc)|"Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||percentage of participants|||Number
1345537|NCT01860703|Primary|Maximum Postdose QT/QTc Interval|"The maximum post-dose QT/QTc interval for deferiprone and placebo.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||percentage of participants|||Number
1345538|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||milliseconds||Standard Deviation|Least Squares Mean
1345539|NCT01860703|Secondary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||hour||Standard Deviation|Mean
1345540|NCT01860703|Secondary|AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide|"AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||μg *hr/mL||Standard Deviation|Mean
1345541|NCT01860703|Secondary|Tmax of Deferiprone and Deferiprone 3-O-glucuronide|"To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||hour||Full Range|Median
1345542|NCT01860703|Secondary|Cmax of Deferiprone and Deferiprone 3-O Glucuronide|"To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||μg/mL||Standard Deviation|Mean
1345543|NCT01860703|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone|From administration of the first dose until 7 days +/- 1 day following the final dose|The Safety Analysis Set consisted of all subjects who received at least 1 dose of study medication and had at least 1 safety assessment.|||participants|||Number
1345544|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||milliseconds||Standard Deviation|Least Squares Mean
1345545|NCT01860677|Secondary|Change in Visual Analogue Scale (VAS) in Active Stimulation Arm|"Visual Analogue Scale (VAS) ranges from 0-100. Anchors of “not at all” (0) to “most ever” (100) were used to rank the following:~anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment."|within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|"Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.~3 participants were missing data on these measures."|||units on a scale||Standard Deviation|Mean
1345690|NCT01858766|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1350456|NCT01790828|Secondary|Percentage of Participants Experiencing Hemorrhages During Prophylaxis||4 years|All enrolled participants; n (number) equals (=) number of participants with nonmissing values|||percentage of participants|||Number
1345546|NCT01860677|Secondary|Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm|"Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of not at all (10) to most ever (50) were used to rank each measure. Change compares post-treatment to pre-treatment.~Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Participants in the active stimulation arm. Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.|||units on a scale||Standard Deviation|Mean
1345547|NCT01860677|Secondary|BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only|"Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.~The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only|||coupling ratio||Standard Deviation|Mean
1345548|NCT01860677|Primary|BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits|"Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.~The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Data were not collected||||||
1345549|NCT01860586|Other Pre-specified|Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).|Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.|6 months|Final logMAR visual acuity of patients treated with bevacizumab|||logMAR visual acuity||Standard Deviation|Mean
1345550|NCT01860586|Secondary|The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)|To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .|6 months|Number of patients treated with bevacizumab who developed epiretinal membrane|||Participants|||Count of Participants
1345551|NCT01860586|Primary|The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)|This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.|up to 6 months|Bevacizumab treated patients with recurrent retinal detachment|||Participants|||Count of Participants
1345552|NCT01860573|Secondary|Serum Blood Urea Nitrogen||Day of life 1, 2, 3, 5 and 7||||mg/dL||Standard Deviation|Mean
1345553|NCT01860573|Secondary|Serum Creatinine||Day of life 1, 2, 3, 5 and 7||||mg/dL||Standard Deviation|Mean
1345554|NCT01860573|Secondary|Serum Bicarbonate||Day of life 1, 2, 3, 5 and 7||||mmol/L||Standard Deviation|Mean
1345555|NCT01860573|Primary|Cognitive Development Score|Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40–160. Higher values indicate a better outcome.|18-22 months corrected gestational age|Data not available for subjects who died or were lost to follow up.|||units on a scale||Standard Deviation|Mean
1345556|NCT01860573|Primary|Number of Participants With Head Circumference <10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age and some data were missing.|||Participants|||Count of Participants
1345557|NCT01860573|Primary|Number of Participants With Length <10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age, and some data were missing.|||Participants|||Count of Participants
1345558|NCT01860573|Primary|Number of Participants With Weight<10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age|||Participants|||Count of Participants
1345559|NCT01860534|Secondary|Pain|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores > to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||units on a scale||Standard Deviation|Mean
1345560|NCT01860534|Secondary|Oxygen Percent Saturation|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||percent saturation||Standard Deviation|Mean
1345561|NCT01860534|Secondary|Respiratory Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||Breaths per minutes||Standard Deviation|Mean
1345562|NCT01860534|Primary|Heart Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||Beats per minutes||Standard Deviation|Mean
1345563|NCT01860521|Secondary|Total Sufentanil Consumption.||During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).||||microg||Standard Deviation|Mean
1345564|NCT01860521|Secondary|Total Levobupivacaine Consumption||At the moment of fetal expulsion (up to 66 hours from starting of the procedure).||||mg||Standard Deviation|Mean
1345565|NCT01860521|Secondary|Degree of Satisfaction of the Patients With the Analgesia Procedure|At discharge from the hospital, patients were requested to answer the following question “Taking into consideration the variations in pain symptoms, as well as the adverse events experienced, if any, how would you define the grade of satisfaction with your analgesic treatment?” The grade of satisfaction was assessed using a visual analog scale (VAS) where 0 corresponded to “completely unsatisfied” and 100 to “completely satisfied”.|At discharge from the hospital (up to 72 hours from starting of the procedure).||||mm||Standard Deviation|Mean
1345566|NCT01860521|Primary|Incidence of Motor Block|The assessment of the degree of motor block was performed in the right and left lower extremities using the Breen modified Bromage score: 1 = complete block (unable to move feet or knees), 2 = almost complete block (able to move feet only), 3 = partial block (just able to move knees), 4 = detectable weakness of hip flexion while supine (between scores 3 and 5), 5 = no detectable weakness of hip flexion while supine (full flexion of knees), and 6 = able to stand and to perform partial knee bend. Patients with a Bromage score < 6 were considered to have motor block.|Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).||||participants|||Number
1345567|NCT01860170|Other Pre-specified|GVHD|"aGVHD onset at a certain grade will be used to calculate the cumulative incidence for that grade (e.g., onset of grade 70 post-transplant , time to grade III is 70 days). This end point will be evaluated through day 150 post-transplant. The diagnosis of aGVHD is based on clinical and pathological evaluation by the treating physician.~The first day of cGVHD will be used to calculate the cumulative incidence of cGVHD. The diagnosis of cGVHD is based on clinical and pathological evaluation by the treating physician."|Assessed routinely by clinical and pathological evaluation. Acute GVHD will be assessed up to day 150 post-transplant. Chronic GVHD will be assess up to 2 years post-transplant.||||participants|||Number
1345568|NCT01860170|Secondary|Engraftment|"Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) > 0.5 109/L for 3 consecutive measurements on different days. The first of the 3 days will be considered the day of neutrophil engraftment.~Platelet engraftment is defined as platelet count > 20 109/L for 3 consecutive measurements over at least 3 days. The first of the 3 days will be considered the day of platelet engraftment.~In this study, graft failure is defined as lack of achieving neutrophil engraftment by day 22 and donor chimerism > 50% by day 45."|Assessed daily by laboratory evaluation until engraftment or up to 90 days.||||Participants|||Count of Participants
1345569|NCT01860170|Primary|Dose Limiting Toxicity|Grade 3 non-hematologic Common Toxicity Criteria toxicity directly related to bortezomib (such as peripheral neuropathy) or Grade 2 or > hepatic bilirubin Common Toxicity Criteria Graft failure|Assessed daily (while inpatient) through clinical and laboratory examination up to 90 days.||||Participants|||Count of Participants
1345570|NCT01860079|Primary|All Cause Mortality and Readmission at 30 Days.|The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.|30 DAYS||||participants|||Number
1345571|NCT01860040|Primary|Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions|One year|There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.||||||
1345572|NCT01859988|Secondary|Changes in GISS Cumulative Score From Baseline to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
1345573|NCT01859988|Secondary|Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
1345574|NCT01859988|Secondary|Absolute Change in POEM Scores From Baseline to Week 16|POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
1345809|NCT01856907|Primary|Normalization of Glucose Levels|Normalization of glucose in patients with abnormal glucose levels is defined as a fasting glucose level of <100 mg/dL and a 2-hour glucose level following a 75 gram oral glucose load of <140 mg/dL|16 weeks||||Participants|||Count of Participants
1345575|NCT01859988|Secondary|Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16|POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.|||Percent change||Standard Error|Least Squares Mean
1345576|NCT01859988|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16.|Week 16|Analysis was performed on FAS. Participants with a missing SCORAD score at Week 16 were treated as non-responders.|||Percentage of participants||95% Confidence Interval|Number
1345577|NCT01859988|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16.|Week 16|Analysis was performed on FAS. Participants with a missing EASI score at Week 16 were treated as non-responders.|||Percentage of participants||95% Confidence Interval|Number
1345578|NCT01859988|Secondary|Absolute Change in SCORAD Scores From Baseline to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
1345579|NCT01859988|Secondary|Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.|||Percent change||Standard Error|Least Squares Mean
1345580|NCT01859988|Secondary|Absolute Change in EASI Score From Baseline to Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with EASI score assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.|||Units on a scale||Standard Error|Least Squares Mean
1345581|NCT01859988|Secondary|Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16|Pruritus NRS is an assessment tool that is used to report the intensity of participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed =participants with pruritus NRS assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1345582|NCT01859988|Secondary|Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16|Pruritus NRS is an assessment tool that is used to report the intensity of participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with pruritus NRS assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.|||Percent change||Standard Deviation|Mean
1345583|NCT01859988|Secondary|Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.|Week 16|Analysis was performed on FAS.|||Percentage of participants||95% Confidence Interval|Number
1345870|NCT01856257|Secondary|Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52|Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.|Enrollment through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345584|NCT01859988|Secondary|Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.|Week 16|Analysis was performed on FAS.|||Percentage of participants||95% Confidence Interval|Number
1345585|NCT01859988|Primary|Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) that included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants with EASI score assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by last observation carried forward (LOCF).|||Percent change||Standard Deviation|Least Squares Mean
1345586|NCT01859949|Secondary|Height SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.~Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
1345587|NCT01859949|Secondary|Height Velocity SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.~Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
1345588|NCT01859949|Secondary|Height SDS for Chronological Age|"Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values on the participant age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
1345589|NCT01859949|Secondary|Height Velocity|Height velocity is the yearly height gain|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||cm/year||Standard Deviation|Mean
1345590|NCT01859949|Secondary|Height Velocity Standard Deviation Score (SDS) for Chronological Age|"Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values of the participants age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
1345591|NCT01859949|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||participant|||Number
1345592|NCT01859793|Secondary|Circulating Inflammatory Markers VCAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subject who completed the study. Once subject had missing data for the post-8 weeks of each intervention|||mg/mL||Standard Deviation|Mean
1345593|NCT01859793|Secondary|Circulating Inflammatory Marker ICAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subjects who completed both arms of the study. One subject was missing the measurements post 8 weeks of each intervention arm and was excluded|||mg/mL||Standard Deviation|Mean
1345594|NCT01859793|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans|Change before and after a single dose (2 hours post) and 8 weeks after daily dosing|All 30 subjects who completed both arms of the cross-over study|||%FMD||Standard Deviation|Mean
1345595|NCT01859715|Secondary|Adverse Drug Events|Determine all possible adverse drug events that occurred after the study drugs were administered.|Duration of ED stay, <24 hours. (up to 24 hours)||||participants|||Number
1345596|NCT01859715|Primary|Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users|Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.|Baseline and 90 minutes||||millimeters||95% Confidence Interval|Mean
1345691|NCT01858766|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1345597|NCT01859702|Primary|Mean Aqueous Humor Concentration of Moxifloxacin|A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.|Day 3 (operative day)|Per protocol: All subjects who met inclusion/exclusion criteria, received all doses of the test product, and underwent cataract surgery with aqueous humor sampling.|||nanograms per milliliter||95% Confidence Interval|Mean
1345598|NCT01859637|Secondary|Change in Absolute Neutrophile Count (ANC)|"To evaluate the efficacy of Zarzio®/Filgrastim HEXAL® in patients with SCN in terms of changes in absolute neutrophile count (ANC).~Change from each visit to baseline in ANC for all patients is calculated."|Participants were followed for a duration of 12 months and ANC was assessed at baseline, week 6, Month 3, Month 6, Month 9 and Month 12.|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment|||10^9 cells/L||Full Range|Median
1345599|NCT01859637|Secondary|Number of Participants With Adverse Events (AEs)|Patients experiencing AEs by system organ class and preferred term (PT) and number of events. Patients with more than one AE coded to the same PT were counted once per PT|12 months|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment|||participants|||Number
1345600|NCT01859637|Primary|Incidence of Anti- Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) Antibodies|"Incidence of anti-rhG-CSF antibodies was monitored. Patients were screened for anti-rhG-CSF antibodies at screening and at each study except visit 02 (start of treatment = baseline).~Evaluation of immune response to rhG-CSF administration was made by a three-step procedure comprising a validated binding antibody screening and confirmatory radioimmunoprecipitation assay (RIP) and a validated cell-based neutralization antibody assay (NAB)."|screening, 3, 6, 9 and 12 months|Safety population (SAF): All patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment. All six patients were screened for anti-rhG-CSF antibodies at all six study visits, except for one missing assessment (no sample was taken for patient 0204 at Visit 03, which was an optional visit).|||participants|||Number
1345601|NCT01859611|Secondary|Adverse Events.|At every treatment and follow-up visit the treated areas will be examined to evaluate side effects and adverse reactions remaining from the previous treatment session or occurring since then.|Subjects will be followed for the duration of the study, and expected average of 20 weeks|||||||
1345602|NCT01859611|Secondary|Patient Satisfaction and Comfort of the Treatment.|At each of the specified time points, subjects will complete a Subject Evaluation Form assessing their opinion of improvement and overall satisfaction with treatment.|Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU|||||||
1345603|NCT01859611|Primary|Changes to the Surface by Visual and Photographic Analysis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri-orbital wrinkles.~Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale.~Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe"|3 Month FU|Number of participants with observed changes (grade of improvement ≥ 1) to the surface of the skin based on photographic analysis at 3 Month FU|||participants|||Number
1345604|NCT01859598|Secondary|Overall Weight Gain From Visit 1 to Visit 3|the weight gain= the mean weight at visit1 - the mean weight at visit 3|baseline and 6 months|Patients at visit 3 were used for analyzing the change of weight|||Kg||Standard Deviation|Mean
1345605|NCT01859598|Secondary|the FPG Control Rate at Visit 3|the percentage of patients who had the FPG level <7.0 mmol/L at visit 3|6 months|At visit 3, the patients who self-reported their FPG level were used for analysis|||percentage of patients with FPG<7.0|||Number
1345606|NCT01859598|Secondary|the FPG Change From Visit 1 to Visit 3|the FPG change = the FPG level at visit 1- the FPG level at visit 3|baseline and 6 months|the population in the visit 3 were used for analysis|||mmol/L||Standard Deviation|Mean
1345607|NCT01859598|Primary|the Change of Hypoglycemia During Follow-up.|•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)|baseline and 6 months|The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3|||percentage of patients with hypoglycemia|||Number
1345608|NCT01859598|Primary|To Assess the Change in HbA1c During the 6 Months Follow-up.|• Change of HbA1c from baseline to the end-point (6 month).|Baseline and 6 months|the patients who have the results of HbA1c|||percent||Standard Deviation|Mean
1345609|NCT01859507|Secondary|Successful Sexual Relationship|The level of comfort by the couple. The secondary outcome will be assessed by the couple. The couple is allowed to visit for follow up every three months for twelve months. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completedwithout premature interruption from either partners.|Within twelve months after the Botox injection||||participants|||Number
1345610|NCT01859507|Primary|Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain|The primary outcome will be assessed by the couple. The couple is allowed to visit for follow up in a 4 weeks' time. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completed without premature interruption from either partners.|Up to four weeks following the last session of the vaginal dilatation.|multiple penetration with minimal pain as informed by the couple during their follow up sessions 4 weeks after the completion of the dilatation sessions|||participants|||Number
1345611|NCT01859494|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event).|||Participant Responses|||Number
1345721|NCT01858376|Secondary|C-reactive Protein|C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.|Baseline and 14 weeks||||mg/L||Standard Deviation|Mean
1345612|NCT01859494|Secondary|Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject.|||Blood Glucose results within 15mg/dL/20%|||Number
1345613|NCT01859494|Secondary|Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing.|||Blood Glucose results within 15mg/dL/20%|||Number
1345614|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) or +/- 12.5% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.|||Bld Glucose results w/in 12.5mg/dL/12.5%|||Number
1345615|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.|||Blood Glucose results within 15mg/dL/15%|||Number
1345616|NCT01859494|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject.|||Blood Glucose results within 15mg/dL/20%|||Number
1345617|NCT01859390|Secondary|Number of Participants Hospitalized|Number (%) of participants with at least one hospitalization between Baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of followup (Week 18)||||Participants|||Count of Participants
1345618|NCT01859390|Secondary|Number of Participants With Pulmonary Exacerbations|Number (%) with at least one protocol-defined PEx between baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of follow up (Week 18)||||Participants|||Count of Participants
1345619|NCT01859390|Secondary|Number of Pulmonary Exacerbations|The total number of PEx between baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of follow up (Week 18)||||Pulmonary Exacerbations|||Number
1345620|NCT01859390|Secondary|Time to First Pulmonary Exacerbation|Median time to first pulmonary exacerbation (PEx) between baseline (Visit 2) and end of follow up (Week 18)|Baseline (Visit 2) to end of follow up (Week 18)||||days||95% Confidence Interval|Median
1345621|NCT01859390|Secondary|Change in Growth Endpoints|Absolute change in Body Mass Index (BMI) (kg/m^2) between Baseline and Week 16.|Baseline (Visit 2) to Week 16|This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have final height and weight assessments.|||kg/m^2||Standard Deviation|Mean
1345622|NCT01859390|Secondary|Change in Lung Function|Absolute Change in Forced Expiratory Volume over one second (FEV1) % predicted between Baseline and Week 16. Global Lung Initiative equations were used to calculate FEV1 %predicted.|Baseline (Visit 2) to Week 16|This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have a final lung function assessment.|||FEV1 %Predicted||Standard Deviation|Mean
1345623|NCT01859390|Secondary|Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Rate is defined as the number of events per participant follow-up week.|18 weeks follow up||||events per participant-week|||Number
1345624|NCT01859390|Secondary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.|18 weeks follow up||||Participants|||Count of Participants
1345625|NCT01859390|Primary|Change in Sputum Myeloperoxidase (MPO) Level|The primary outcome is the difference in 16 week mean change in log10 sputum myeloperoxidase levels between the AquADEKs-2 arm and the Control Multivitamin arm.|Baseline (Visit 2) to Week 16 (Visit 4)||||log10 (ng/mL)||Standard Deviation|Mean
1345722|NCT01858376|Secondary|Changes in High-Sensitivity C-reactive Protein|High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks||||mg/dl||95% Confidence Interval|Mean
1345626|NCT01859325|Secondary|HIV-1 Viral Load Following Antiretroviral Treatment Interruption (ATI).|The difference in HIV-1 viral load at the end of the ATI between the vaccine and placebo groups. Levels of plasma viremia in the vaccine and placebo groups were compared using the Wilcoxon rank sum test at the end of treatment interruption periods to determine the antiviral efficacy of the therapeutic vaccine regimen. The limit of detection of plasma viremia was 40 copies/ml of HIV RNA.|72 weeks|All subjects who received vaccine or placebo|||copies/ml||Inter-Quartile Range|Median
1345627|NCT01859325|Primary|The Rate of Related Adverse Events in Subjects Who Began cART During Acute or Early HIV-1 Infection.|"The rate of occurrence of grade 3 or higher AEs, including serious adverse events (SAEs) that per standard criteria (see safety section) are:~At least possibly related to the test article, and Definitely NOT related to a factor other than the test article This is to evaluate safety and tolerability of the study vaccines."|48 weeks|All subjects who received vaccine or placebo|||Related Adverse Events|||Number
1345628|NCT01859312|Secondary|Participant Lean Body Mass|lean body mass measured by DEXA, Hologic Discovery-A|At 6 months||||kg||Standard Error|Mean
1345629|NCT01859312|Secondary|Participant Lean Body Mass|lean body mass measured by DEXA, Hologic Discovery-A|At baseline||||kg||Standard Error|Mean
1345630|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
1345631|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
1345632|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
1345633|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
1345634|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
1345635|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
1345636|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
1345637|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
1345638|NCT01859312|Secondary|Participants Mean Progesterone Level at 0700|Participants Mean Level of Progesterone at 0700|At 6 months||||ng/mL||Standard Error|Mean
1345639|NCT01859312|Secondary|Participants Mean Progesterone Levels at 0700|Participants Mean Level of Progesterone at 0700|At baseline||||ng/mL||Standard Error|Mean
1345640|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
1345641|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
1345642|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
1345643|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
1345644|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
1345645|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
1345646|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
1345647|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
1345648|NCT01859312|Secondary|Participants Mean Level of ACTH at 0700|Participants Mean Level of ACTH at 0700.|At 6 months||||pg/mL||Standard Error|Mean
1345649|NCT01859312|Secondary|Participants Mean Level of ACTH at 0700|Participants Mean Level of ACTH at 0700.|At baseline||||pg/mL||Standard Error|Mean
1345650|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345651|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345652|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345653|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345654|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345655|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345656|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Androstenedione area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345657|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345658|NCT01859312|Secondary|Participants Mean Level of Androstenedione at 0700|Participants Mean Level of Androstenedione at 0700.|At 6 months||||ng/dL||Standard Error|Mean
1345659|NCT01859312|Secondary|Participants Mean Level of Androstenedione at 0700|Participants Mean Level of Androstenedione at 0700.|At baseline||||ng/dL||Standard Error|Mean
1345660|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345661|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345662|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345663|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345664|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345665|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345666|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
1345667|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
1345668|NCT01859312|Secondary|Participants Mean Level of 17-OHP at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At 6 months||||ng/dL||Standard Error|Mean
1345669|NCT01859312|Secondary|Participants Mean Level of 17-OHP at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At baseline||||ng/dL||Standard Error|Mean
1345670|NCT01859312|Primary|Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At 6 months||||Participants|||Count of Participants
1345671|NCT01859312|Primary|Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At baseline||||Participants|||Count of Participants
1345672|NCT01859247|Secondary|Composite Measure of Patient Rating of Symptoms and Tolerability|"This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being completely tolerable and 10 completely intolerable."|Assessment completed immediately after rTMS treatment session||||units on a scale||Standard Deviation|Mean
1345673|NCT01859247|Secondary|Dorsal Premotor-motor Inhibition (dPMI)||Change from baseline dPMI to post-intervention within 1 hour of treatment|two subjects did not have dPMI measured|||percentage||Standard Deviation|Mean
1345676|NCT01859195|Primary|Number of Participants: Comprehension of Study Product|"Focus groups captured participant understandings (in narrative form) of plant-produced monoclonal antibodies, how they come about, how they are manufactured, how they differ from other anti-HIV actives, etc. Participant-derived language informed development of study materials, including study product instruction sheets and informed consent materials and documents.~Cognitive Interview assessed Participant comprehension of language used in insertion instruction materials, and monoclonal antibody education and informed consent materials."|1 year||||Participants|||Count of Participants
1345677|NCT01859143|Secondary|Percentage of Participants Who Required Antipyretic and/or Analgesic Medication||Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||percentage of participants|||Number
1345678|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 180 days after the dose that were absent before treatment or that worsen relative to pretreatment state. An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Results are given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.|Within 28 and 180 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||participants|||Number
1345679|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 14 days after vaccination that were absent before treatment or that worsened relative to pre-treatment state. Results are given for AEs reported within 7 days and 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||participants|||Number
1345680|NCT01859143|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms included fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results are reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||percentage of participants|||Number
1345681|NCT01859143|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Within 7 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||percentage of participants|||Number
1345682|NCT01859078|Secondary|PK: Renal Clearance (CLr) of Digoxin|CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ.|Predose to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate CLr. Participants were analyzed based on the treatment they received.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1345683|NCT01859078|Secondary|PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin||0 to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate Aeτ. Participants were analyzed based on the treatment they received.|||milligrams (mg)||Geometric Coefficient of Variation|Geometric Mean
1345684|NCT01859078|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate tmax. Participants were analyzed based on the treatment they received.|||hours (h)||Full Range|Median
1345685|NCT01859078|Primary|PK: Maximum Concentration (Cmax) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate Cmax. Participants were analyzed based on the treatment they received.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1345686|NCT01859078|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate AUCτ. Participants were analyzed based on the treatment they received.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1345687|NCT01859013|Primary|Percent Change From Baseline in Body Mass Index at 28-Weeks|The Percent Change from Baseline in Body Mass Index at 28-Weeks|Baseline and 28-Weeks||||% change BMI||Standard Deviation|Mean
1345688|NCT01858766|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1345692|NCT01858701|Primary|Mean Ocular Coma Score at 5mm Pupil at Day 30|Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.|Day 30|This analysis population includes all participants who completed the study.|||micrometers||Standard Deviation|Mean
1345693|NCT01858636|Primary|The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.||within 5 minutes of device deployment||||% of proc. w/hemostasis within 5 min|Participants|95% Confidence Interval|Number
1345694|NCT01858636|Primary|The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication|"Major vascular complications include:~Access Site Complications:~Hematoma >10 cm in size requiring surgical or percutaneous intervention~Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention~Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention~Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics~A/V Fistula requiring medical intervention (percutaneous or surgical)~Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)"|30 days post procedure|All subjects with device deployments.|||% of subjects with MVCs||95% Confidence Interval|Number
1345695|NCT01858545|Primary|The Incidence of Complete Wound Closure||8 Weeks||||Participants|||Count of Participants
1345696|NCT01858428|Secondary|Change in Ankle-brachial Index (ABI) From Pre-procedure|Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.|6, 12, 24 and 36 months||||Participants|||Count of Participants
1345697|NCT01858428|Secondary|Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure|Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.|procedure, Day 0||||Participants|||Count of Participants
1345698|NCT01858428|Secondary|Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure|Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.|procedure, Day 0||||participants|||Number
1345699|NCT01858428|Secondary|Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%|Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.|procedure, Day 0||||Lesion|||Number
1345700|NCT01858428|Secondary|Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%|Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.|procedure, Day 0||||participants|||Number
1345701|NCT01858428|Secondary|Patency Rate and Freedom From Clinically-driven TLR|Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months|6, 24 and 36 months||||participants|||Number
1345702|NCT01858428|Secondary|Rate of Occurrence of Arterial Thrombosis of the Treated Segment||1, 6, 12, 24, 36, 48 and 60 months||||participants|||Number
1345703|NCT01858428|Secondary|Mortality Rate||6, 12, 24, 36, 48 and 60 months||||participants|||Number
1345704|NCT01858428|Secondary|Rate of Target Limb Major Amputation||1, 6, 12, 24, 36, 48 and 60 months||||participants|||Number
1345705|NCT01858428|Secondary|Rate of Target Lesion Revascularization||6, 12, 24, 36, 48 and 60 months||||participants|||Number
1345706|NCT01858428|Secondary|Rate of Clinically-driven Target Lesion Revascularization||6, 12, 24, 36, 48 and 60 months||||participants|||Number
1345707|NCT01858428|Secondary|Rate of Vascular Access and Bleeding Complications|Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.|in-hospital and 1, 6, 12 and 24 months||||participants|||Number
1345708|NCT01858428|Secondary|Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure|Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).|1, 6, 12, 24, 36, 48 and 60 months||||Events|||Number
1345709|NCT01858428|Primary|Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization|Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.|30 Days and 12 months|Some Safety Status Missing at 12 Months Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have had a primary safety event within 12 months prior to study exit.|||Participants|||Count of Participants
1345710|NCT01858428|Primary|Patency at 12 Month Post-procedure|Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.|12 months|Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have been eligible for failures carried forward or had a Clinically driven target lesion revasc (CD-TLR) prior to study exit.|||Participants|||Count of Participants
1345711|NCT01858389|Secondary|Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG)|ECGs recorded on Day 1 of Cycle 0 were used as baseline. For the ECGs assessments, the following directions were followed by the ECG central laboratory: Blinding of ECG readers to treatment, time, and day identifiers. Review of ECGs from a particular participant was performed by a single reader. Prespecification of the lead for internal measurements. Baseline and on-treatment ECG assessments were based on the same lead.|From Baseline to Cycle 0, Day 4|All participants who received all scheduled doses of dacomitinib and had all ECGs performed on Days 1-4 of Cycle 0 (n=number evaluable)|||msecs||90% Confidence Interval|Mean
1345712|NCT01858389|Secondary|Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265|Tmax was observed directly from data as time of first occurrence. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.|Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.|All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265.|||Hours||Full Range|Median
1345713|NCT01858389|Secondary|Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265|Cmax was observed directly from data. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.|Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.|All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265.|||ng/mL||Standard Deviation|Mean
1345714|NCT01858389|Primary|Objective Response Rate (ORR) in Participants With T790M Mutation|ORR was calculated as the percentage of participants with a confirmed CR or PR relative to the total number of participants enrolled. Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1 were used to define CR and PR. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. ORR was analyzed only for participants with T790M mutation according to the primary study objective.|From baseline to disease progression, up to 61 weeks.|All enrolled participants with T90M mutation|||Percentage of participants||95% Confidence Interval|Number
1345715|NCT01858389|Secondary|Progression-free Survival at 4 Months|Progression-free survival at 4 months was defined as the percentage of participants who were alive without disease progression at 4 months relative to all participants enrolled. Disease progression was defined by RECIST v1.1. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|Month 4|All enrolled participants|||Percentage of participants||95% Confidence Interval|Number
1345716|NCT01858389|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the date of first dosing of dacomitinib to the date of disease progression by RECIST v1.1, per the investigators’ assessment, or death due to any cause, whichever occurred first. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From baseline to disease progression or death, up to 61 weeks.|All enrolled participants|||Months||95% Confidence Interval|Median
1345717|NCT01858389|Secondary|Duration of Response in Participants With T790M Mutation|Duration of response was defined as the time from first documentation of response (CR or PR, whichever occurred first) to the date of disease progression or to death due to any cause, whichever occurred first. CR and PR were defined using RECIST, v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. DR was only calculated and summarized for the subgroup of participants with an objective tumor response in the cohort of participants with T790M mutation.|From baseline to date of disease progression or death, up to 61 weeks.|All enrolled participants with T790M mutation status who had an objective tumor response (complete or partial response)|||Months|||Number
1345718|NCT01858389|Secondary|Disease Control Rate (DCR) for Participants With T790M Mutation|DCR was calculated as the percentage of participants with an objective response (CR or PR) or stable disease, based on the RECIST, v1.1, relative to the total number of participants enrolled in the cohort. If baseline tumor assessment was inadequate for a participant, and the participant could not be assessed for RECIST responses and had no objective status of stable disease documented at least 6 weeks after the start date and before the progression, the participant was only counted in the denominator. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. DCR was analyzed only for participants with T790M mutation according to the study objective.|From baseline to baseline to disease progression, up to 61 weeks.|All enrolled participants with T790M mutation|||Percentage of participants||95% Confidence Interval|Number
1345719|NCT01858389|Primary|Best Overall Response (BOR) in Participants With T790M Mutation|BOR was best response from start of treatment until disease progression, according to the RECIST,v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. Progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. Stable disease=not qualify for CR, PR or progression. BOR was analyzed only for participants with T790M mutation according to the primary study objective.|From baseline until disease progression, up to 61 weeks.|All enrolled participants with T790M mutation|||Participants|||Number
1345720|NCT01858376|Secondary|Changes From Baseline in Platelet Aggregometry|Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks||||maximum % aggregation||95% Confidence Interval|Mean
1345723|NCT01858376|Primary|Change From Baseline in Lipid Profile|Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|number of participants analyzed is different from the participant flow module due to subjects who self reported non-compliance from pill count of the supplements and their data was not able to be used for this outcome measure.|||mg/dl||95% Confidence Interval|Mean
1345724|NCT01857986|Post-Hoc|Duration of Significant CO2 Leakage|Time (minutes) of CO2 leakage readings at or above 2 mmHg|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days||||minutes||Standard Deviation|Mean
1345725|NCT01857986|Secondary|Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)|mean number of cuff pressure measurements within the safety accepted range of 24 and 40 cmH2O, normalized using the total number of valid cuff pressure measurements.|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days||||normalized number of Cp measurements||Standard Deviation|Mean
1345726|NCT01857986|Primary|CO2 Leakage Above the ETT Cuff, Measured Over Time.|"Trial outcome measure represents patients’ exposure to CO2 leakage standardized per hour. Specifically, each patients’ area under the curve (AUC) of CO2 leakage (mmHg) is computed over the whole trial by multiplying leakage duration (X-axis; continuous time) by CO2 level (Y-axis; mmHg), divided by the patient’s number of hours in the trial. Outcome measure is thus [CO2 mmHg*hour]/hour.~CO2 leakage is the concentration of CO2 above the cuff as measured by the AG100 system every few minutes (in clinical mode). Time points which created the curve were every two adjacent time intervals having a valid CO2 reading."|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days||||[CO2 mmHg*hour]/hour||Standard Deviation|Mean
1345727|NCT01857882|Other Pre-specified|Completion of Primary Outcome Measure-feasibility Outcome|Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.|1 week after initial consultation|||||||
1345728|NCT01857882|Other Pre-specified|Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome|The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered.|Duration of treatment-8 hours on day of treatment|||||||
1345729|NCT01857882|Other Pre-specified|Recruitment Rate-feasibility Outcome|As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.|Duration of recruiting, expected on average two months|||||||
1345730|NCT01857882|Secondary|Medical Outcomes Study Social Support Survey|Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support.|baseline|||||||
1345731|NCT01857882|Secondary|Breast Reconstruction Knowledge Test|This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.|Change in baseline breast reconstruction knowledge at 1 week after initial consultation|||||||
1345732|NCT01857882|Secondary|Number of Consultations-service Outcomes|The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.|Six months after initial consultation|||||||
1345733|NCT01857882|Secondary|Length of Consultation-service Outcome|The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.|Duration of initial consultation|||||||
1345734|NCT01857882|Secondary|Uptake Rate of Breast Reconstruction-Service Outcome|The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)|Six months after initial consultation|||||||
1345735|NCT01857882|Secondary|Qualitative Interview Assessment|A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.|Within three months after initial consultation|||||||
1345736|NCT01857882|Secondary|Satisfaction With Information (Sub-scale of BREAST-Q)|"The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The Satisfaction with Information Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction."|T1 (1 week after surgical consultation)|||||||
1345737|NCT01857882|Secondary|Patient Involvement in Care Scale (PICS)|PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.|T1 (1 week after surgical consultation)|||||||
1345738|NCT01857882|Secondary|Decision Preference and Decision Choice|Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention.|baseline|||||||
1345757|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 2-week Abstinence From Smoking|Continuous two week abstinence from smoking at the first post-quit visit (approximately 2 weeks post quit date), based on self-reported abstinence confirmed by expired air CO.|2 Weeks post quit||||participants||95% Confidence Interval|Number
1345739|NCT01857882|Secondary|Decision Conflict Scale|Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).|Change from baseline decision conflict at 1 week after surgical consultation|||||||
1345740|NCT01857882|Primary|Decision Self-efficacy Scale|"Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.~The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).~The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation."|Change from baseline decision self-efficacy at 1 week after surgical consultation||||units on a scale||Standard Deviation|Mean
1345741|NCT01857713|Other Pre-specified|Investigator Questionnaire|Investigators provide their perception of the device at the end of the study.|4 Weeks|||||||
1345742|NCT01857713|Other Pre-specified|Patient Satisfaction|Patients provide their perception of the device at the end of the study.|4 Weeks|||||||
1345743|NCT01857713|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).|||Change in Units on a Scale||Standard Deviation|Mean
1345744|NCT01857713|Secondary|SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).|||Change in Units on a Scale||Standard Deviation|Mean
1345745|NCT01857713|Primary|Primary Safety|Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.|4 Week Follow-up|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).|||% Reporting Any Adverse Event|||Number
1345746|NCT01857713|Primary|Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks|The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).|4 Weeks minus Baseline||||Per Cent Change||Standard Deviation|Mean
1345747|NCT01857622|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)|3 months||||percentage of subjects with bleeds||95% Confidence Interval|Number
1345748|NCT01857583|Secondary|Incidence of Adjudicated Thromboembolic Events|Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).|1 month|||||||
1345749|NCT01857583|Primary|Plasma Concentration of D21-2393||14 days|||||||
1345750|NCT01857583|Primary|Plasma Concentration of DU-176b||14 days|||||||
1345751|NCT01857583|Primary|Incidence of Adverse Drug Reactions||1 month|||||||
1345752|NCT01857583|Primary|Incidence of Adverse Events||1 month|||||||
1345753|NCT01857583|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).|14 days|The safety analysis set was defined as all subjects who were enrolled in the study, except for those who had significant GCP violations, who had not received the study drug, or who had no safety data after the start of study treatment.|||percentage of subjects with bleeds||95% Confidence Interval|Number
1345754|NCT01857531|Other Pre-specified|Number of Participants Completing Abstinence From Smoking During the Last Four Weeks of Treatment|End of treatment abstinence from smoking during the last four weeks of treatment, based on self-reported abstinence during last four weeks confirmed by expired air CO|4 Week abstinence from smoking at 6 weeks post quit||||participants||95% Confidence Interval|Number
1345755|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 6-week Abstinence From Smoking|Continuous six week abstinence from smoking at final study visit (approximately 6 weeks post quit date), based on self-reported abstinence confirmed by expired air CO|6 Weeks post quit|Because 6-week abstinence is counted backward from the final study visit, one additional subject (n=4) qualified as abstinent than at 2-weeks post-quit (n=3) due to the fact that the day(s) that one of the subjects smoked did not fall into the range evaluated at 6 weeks.|||participants||95% Confidence Interval|Number
1345756|NCT01857531|Other Pre-specified|Number of Participants Completing Point Abstinence From Smoking Two Weeks After Quitting|Point abstinence from smoking two weeks post quit, based on self-reported abstinence during last seven days confirmed by expired air CO at first post-quit visit.|7 day point abstinence from smoking at 2 weeks post quit||||participants||95% Confidence Interval|Number
1345758|NCT01857531|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4|To evaluate the effects of ganaxolone as an augmentation treatment in conjunction with nicotine patch by looking at the percent change in expired air CO at the end of week four (relative to baseline).|Baseline and 4 Weeks|Three of the original 16 subjects dropped out prior to week 4, so only 13 subjects had a week 4 CO reading and could be included in this analysis.|||percentage change||Standard Error|Mean
1345759|NCT01857531|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2|To evaluate the effects of ganaxolone on ad lib smoking by looking at the percent change in expired air CO at the end of week two (relative to baseline).|Baseline and 2 Weeks||||percentage change||Standard Error|Mean
1345760|NCT01857362|Primary|The Maximum Serum Concentration (Cmax).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||nM||Full Range|Geometric Mean
1345761|NCT01857362|Primary|The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||uM*h||Full Range|Geometric Mean
1345762|NCT01857323|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 50|Safety population|||participants|||Number
1345763|NCT01857323|Secondary|Absolute Value of Total Discrepancy Size Per Inhaler|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome is calculated for each inhaler as “beginning counter reading minus end counter reading” minus “patient-recorded number of dose cycles. The total inhaler discrepancy size is an important measure because it provides the most relevant means of ensuring that the inhaler does not exhaust its supply of albuterol before the counter has recorded the labeled 200 doses."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/inhaler||Standard Deviation|Mean
1345764|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Up Unknown Dose Cycle|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter counts upwards (number increases, e.g. 50 to 52) rather than downward between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is greater than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
1345765|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Unknown Dose Cycle|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter advances (decreases, e.g., 50 to 48) between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is less than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
1345766|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Count Up|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter reading increases, instead of decreases, after the participant has executed the dose cycle (i.e., the ending counter reading is greater than the beginning counter reading within a dosing session). The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
1345803|NCT01856907|Secondary|Triglyceride/HDL-Cholesterol Ratio|The ratio of triglyceride to HDL cholesterol is used as an indirect measure of insulin resistance|16 weeks||||Ratio||Standard Deviation|Mean
1345804|NCT01856907|Secondary|Oral Disposition Index|Measure of pancreatic beta cell compensatory action known as IS-SI|16 weeks||||index||Standard Deviation|Mean
1345767|NCT01857323|Primary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Not Count|The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not advance (i.e., does not count down) within a dosing session. The discrepancy rate was calculated as “number of discrepancies/total number of dose cycles” *200.|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
1345768|NCT01857297|Secondary|Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs include AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
1345769|NCT01857297|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
1345770|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2 and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
1345771|NCT01857297|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||fold increase||Standard Deviation|Geometric Mean
1345772|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
1345773|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||60 min (baseline)||||nmol/umol||Standard Error|Mean
1345774|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||0 min (baseline)||||nmol/umol||Standard Error|Mean
1345775|NCT01857258|Secondary|Malondialdehyde||60 min postprandially||||uM||Standard Error|Mean
1345776|NCT01857258|Secondary|Malondialdehyde (0 Min)||Baseline (0 min)||||uM||Standard Error|Mean
1345777|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||60 min||||% dilation||Standard Error|Mean
1345778|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||0 min (baseline)||||% dilation||Standard Error|Mean
1345779|NCT01857258|Primary|Area Under the Curve of Brachial Artery Flow Mediated Dilatiion|Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose||||%FMD * min||Standard Error|Mean
1345780|NCT01857258|Primary|Area Under the Curve of Blood Glucose|Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose||||mmol/L * min||Standard Error|Mean
1345781|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.|||Subjects|||Number
1345782|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.|||Subjects|||Number
1345805|NCT01856907|Secondary|Matsuda Index of Insulin Sensitivity|Composite insulin sensitivity index calculated from from glucose and insulin levels obtained during the OGTT|16 weeks||||index||Standard Deviation|Mean
1345806|NCT01856907|Secondary|Fasting Insulin Resistance|Insulin resistance calculated from fasting glucose and insulin levels known as HOMA-IR|16 weeks||||index||Standard Deviation|Mean
1345783|NCT01857206|Primary|Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 7 after any vaccination|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.|||Subjects|||Number
1345784|NCT01857102|Primary|Visual Comfort|The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0. The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life. This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction. An overall score is calculated by averaging the subscales. The overall scores can take on values of 0 to 100. Higher scores indicate better outcomes|1-week follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
1345785|NCT01857102|Primary|Objective Comfort Assessed by Electromyography(EMG)|Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.|1 week|Analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||volts||Standard Deviation|Mean
1345786|NCT01857063|Secondary|Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed. The possible Sneezing Score ranged from 0 to 4, with a higher score indicating more severe sneezing. The Sneezing Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345787|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge.The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345788|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345789|NCT01857063|Secondary|Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345790|NCT01857063|Secondary|Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345791|NCT01857063|Secondary|Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345792|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345793|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345794|NCT01857063|Secondary|Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345795|NCT01857063|Primary|Percentage of Participants Who Experience at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.|Up to 5 weeks|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1345796|NCT01857063|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
1345797|NCT01856933|Secondary|Toxicities (Adverse Events) of PSMA ADC for Patients With Recurrent Glioblastoma.||at least every 3 weeks for a maximum of 30 post coming off drug, approximtely 6 months|||||||
1345798|NCT01856933|Primary|Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.|"The response assessment in neuro-oncology (RANO) will be used to define radiographic response.~(PD): A >25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|3 months until progression, potentially up to 1 year|Progression|||participants|||Number
1345799|NCT01856907|Other Pre-specified|Liver Enzymes as Safety Measure|Number of patients with no clinically significant changes in liver enzymes-measure of liver enzymes was a study safety endpoint|16 weeks||||Participants|||Count of Participants
1345800|NCT01856907|Secondary|Waist-to-Height Ratio|Measure of central obesity adjusted for stature|16 weeks||||Ratio||Standard Deviation|Mean
1345801|NCT01856907|Secondary|Waist Circumference|Measure of central fat|16 weeks||||centimeters||Standard Deviation|Mean
1345802|NCT01856907|Secondary|Body Mass Index|Measure of body weight corrected by height|16 weeks||||kg/meters^2||Standard Deviation|Mean
1345810|NCT01856764|Secondary|Change From Baseline to Day 15 in Participants’ Assessment of Pruritus|Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.|||Scores on a scale||Standard Error|Least Squares Mean
1345811|NCT01856764|Secondary|Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values|Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.|||g/m^2/hr||Standard Error|Least Squares Mean
1345812|NCT01856764|Primary|Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)|Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.|||Scores on a scale||Standard Error|Least Squares Mean
1345813|NCT01856686|Secondary|Inattention Score|Inattention assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome.|3 months||||units on a scale||Standard Deviation|Mean
1345814|NCT01856686|Secondary|Impulsivity Score|Impulsivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months||||units on a scale||Standard Deviation|Mean
1345815|NCT01856686|Secondary|Hyperactivity Score|Hyperactivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months||||units on a scale||Standard Deviation|Mean
1345816|NCT01856686|Other Pre-specified|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements|Up to 8 months||||participants|||Number
1345817|NCT01856686|Other Pre-specified|Body Mass Index at 3 Months|Body mass index after 3 months of dietary approach.|3 months||||kg/m2||Standard Deviation|Mean
1345818|NCT01856686|Secondary|Behavior|"Behavior assessed by total score of clinical questionnaire (sum of Hyperactivity, Impulsivity and Inattention scores), after 3 months of nutritional approach.~Range: minimum value: 0 and maximum value: 25. Higher values represent a worse outcome."|3 months||||units on a scale||Standard Deviation|Mean
1345819|NCT01856686|Primary|Frontal Midline Theta Activity- Amplitude at 3 Months|Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||microvolts||Standard Deviation|Mean
1345820|NCT01856686|Secondary|Monastra Ratio at 3 Months|Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||ratio||Standard Deviation|Mean
1345821|NCT01856686|Primary|Mu Waves-amplitude at 3 Months|Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||microvolts||Standard Deviation|Mean
1345822|NCT01856686|Secondary|Frontal Midline Theta Activity- Frequency at 3 Months|Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
1345823|NCT01856686|Secondary|Mu Wave Frequency at 3 Months|Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
1345824|NCT01856686|Other Pre-specified|Weight at 3 Months|Weight after 3 months of dietary approach.|3 months||||kilograms||Standard Deviation|Mean
1345825|NCT01856686|Secondary|Parietal Alpha Waves-frequency at 3 Months|Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
1345826|NCT01856686|Primary|Occipital Alpha Brainwaves Amplitudes at 3 Months|occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||microvolts||Standard Deviation|Mean
1345827|NCT01856686|Secondary|Occipital Alpha Waves-frequency at 3 Months|occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
1345828|NCT01856686|Primary|Comission Errors at 3 Months|comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)|3 months||||errors||Standard Deviation|Mean
1345829|NCT01856686|Primary|Omission Errors at 3 Months|Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes)|3 months||||errors||Standard Deviation|Mean
1345830|NCT01856686|Primary|Reaction Time at 3 Months|Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||milliseconds||Standard Deviation|Mean
1345840|NCT01856530|Secondary|Perceived Preference Scores on a 1-7 Likert Scale|Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
1345895|NCT01856257|Secondary|Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant|Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345831|NCT01856673|Secondary|Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction|"TMHS scale of 64 items, ranging from 0 for “never” to 3 for “all the time” being the option three the worst condition, including locally relevant symptoms and sub-scales of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (PTSS) (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).~The Dysfunction measure was a gender-specific questionnaire with 12-items for females and 10-items for males. Each item assessed a task ranging from 0 for “no difficulty” to 4 for “cannot do it”, being the option four the worst condition.~For each scale, the mean was calculated in order to used it as the measure for comparisions.~Mean difference in scores of TMHS and Dysfunction between the subject’s baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.||||units on a scale||95% Confidence Interval|Mean
1345832|NCT01856673|Primary|Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.|"Symptoms, ranging from 0 for “never” to 3 for “all the time” being three the worst score, were assessed with adapted versions of Hopkins Symptom Checklist and Harvard Trauma Questionnaire, from which they were analyzed the constructs of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).~For each scale, the mean was calculated in order to used it as the measure for comparisions.~Mean difference in scores of symptoms of anxiety, depression and post-traumatic stress disorders between the subject’s baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.||||units on a scale||95% Confidence Interval|Mean
1345833|NCT01856569|Secondary|Erythrocyte Sedimentation Rate at Baseline|Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).|Baseline|FAS included all participants who met the inclusion criteria.|||millimeter per hour||Standard Deviation|Mean
1345834|NCT01856569|Secondary|C Reactive Protein Level at Baseline|C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.|Baseline|FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||milligram per liter||Standard Deviation|Mean
1345835|NCT01856569|Secondary|Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18|ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant’s quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).|Month 18|"FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable each specified category."|||units on a scale||Standard Deviation|Mean
1345836|NCT01856569|Primary|Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity|Low disease activity was defined as a BASDAI score of less than or equal to (<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.|Month 12, 18|"FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable for each time point."|||percentage of participants|||Number
1345837|NCT01856569|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18|BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.|Baseline, Month 18|FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1345838|NCT01856569|Primary|Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18|First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.|Baseline up to Month 18|FAS included all participants who met the inclusion criteria.|||percentage of participants|||Number
1345839|NCT01856530|Secondary|Perceived Rejection Scores on a 1-7 Likert Scale|Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in this analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
1346327|NCT01851330|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
1345841|NCT01856530|Secondary|Perceived Empathy Scores on a 1-7 Likert Scale|Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
1345842|NCT01856530|Secondary|Perceived Trust Scores on a 1-7 Likert Scale|Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
1345843|NCT01856530|Primary|Disengagement From Social Threat Cues|The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement.|Day 1 (first day oxytocin or placebo was administered)||||Milliseconds||Standard Deviation|Mean
1345844|NCT01856530|Primary|Social Cooperation|"The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as Player 2) played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1."|Day 1 (first day oxytocin or placebo was administered)|Data from 2 participants could not be analyzed due to technical difficulties with the computer task. Thus, the number of participants analyzed was 52 in total, rather than 54.|||Ball tosses||Standard Deviation|Mean
1345845|NCT01856491|Other Pre-specified|Pacing Impedance|"Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician’s Lead Manual. Measurements should fall within the recommended values as mentioned below:~Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20—125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject’s condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected."|3 Months Post-Implant|167 patients have been enrolled. For 150 patients we were able to collect the 3 month pacing impedance|||Ohm||Standard Deviation|Mean
1345846|NCT01856491|Other Pre-specified|Sensed Amplitude|"Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician’s Lead Manual. Measurements should fall within the recommended values as mentioned below:~Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20—125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject’s condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected."|3 Months Post-Implant|167 patients were enrolled. From 141 patients we could collected the sensed amplitude at 3 months|||mVolt||Standard Deviation|Mean
1345847|NCT01856491|Other Pre-specified|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant|3 months through 24 months post implant||2018-11-30|11/2018||||
1345848|NCT01856491|Other Pre-specified|Pacing Threshold at 0.5 ms Pulse Width|Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.|3 Months Post-Implant|167 have been enrolled. 138 were included in the analysis because we have the lead measurements for those number of patients collected .|||Volt||Standard Deviation|Mean
1345849|NCT01856491|Secondary|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.|3 months through 15 months post implant||2018-10-31|10/2018||||
1345850|NCT01856491|Primary|Complication Free Rate|Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.|3-months|167 have been enrolled. 165 were included in the analysis because for 2 patients the leads have not been implanted|||percentage of patients without event||95% Confidence Interval|Number
1345851|NCT01856361|Other Pre-specified|Seminal Angiotensin II and Serum Bradykinin Levels||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
1345852|NCT01856361|Secondary|Hormonal Profile|LH, FSH, serum testosterone, prolactin|32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
1345853|NCT01856361|Secondary|Pregnancy Rate||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
1345854|NCT01856361|Secondary|Total Motile Sperm Count(TMSC), Total Sperm Count, Sperm Motility, and Morphology in the Ejaculate.|The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.|32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
1345855|NCT01856361|Primary|Sperm Density in Infertile Men With Documented Oligospermia.||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
1345856|NCT01856322|Primary|Difference in Circulating S100A4 Transcript in Patients Receiving Sulindac 150 mg BD (Twice Daily) by Mouth Following Resection of Colorectal Cancer Metastases Compared to Those Who do Not.|Difference in circulating S100A4 transcript levels will be determined by assessing the circulating S100A4 transcript level at initial presentation versus the circulating S100A4 transcript level post resection.|3 years|The trial was prematurely closed due to lack of accrual, thus the outcome measure was not met.||||||
1345857|NCT01856270|Secondary|Wechsler Adult Intelligence Scale (WAIS) IV Digit Symbol|The WAIS IV Digit Symbol test will be given to detect any effect of study drug on cognition. This test assesses processing speed and new learning and requires an individual to substitute the relevant digit for a symbol and are given a time limit. The total number of correct digits are summed and converted to a scaled score (range 1-20 with 10 being at the 50th percentile) with higher scores indicating better performance.|30 days||||standard score||Standard Deviation|Mean
1345858|NCT01856270|Secondary|Trail Making Test (B)|Trail Making Test will be given at 30 days to detect any impact of study drug on cognition. This is a test of visual attention and task switching and is scored by number of seconds it takes to complete the task (switching from letters to numbers in order).|30 days||||seconds||Standard Deviation|Mean
1345859|NCT01856270|Secondary|Trail Making Test (A)|Trail Making Test will be given at 30 days to detect any impact of study drug on cognition. This is a test of visual attention and is scored by the number of seconds it takes to complete the task of making a trail through letters.|30 days||||seconds||Standard Deviation|Mean
1345860|NCT01856270|Secondary|Rey Auditory Verbal Learning Test (Long)|The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from the original list of 15 after a 30 minute time delay. Higher scores indicate better long-term memory.|30 days||||words recalled||Standard Deviation|Mean
1345861|NCT01856270|Secondary|Rey Auditory Verbal Learning Test (Short)|The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from the original list of 15 after a new list of 15 is given (used as distraction). Higher scores indicate better short-term memory.|30 days||||words recalled||Standard Deviation|Mean
1345862|NCT01856270|Secondary|Rey Auditory Verbal Learning Test (Total)|The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from a list of 15 across 5 trials (max score of 75) with higher score indicating better learning.|30 days||||words recalled||Standard Deviation|Mean
1345863|NCT01856270|Secondary|Number of Participants With Adverse Events Possibly Related to Study Medication|The number and types of treatment related adverse events will be monitored on a weekly basis and will be divided by severity if differing.|Day 1 through Day 90||||Participants|||Count of Participants
1345864|NCT01856270|Primary|Severity of Headache|Number of subjects with headache reporting an average pain of at least 6 on a 0-10 scale with 0=no pain and 10=worst pain.|90 days|The two arms are combined for this analysis to answer the question of severity of headache at the 3 month outcome data point and only difference between arms was related to onset time of medication which was not expected to result in significant change in headache frequency, but only potentially in cognitive status.|||Participants|||Count of Participants
1345865|NCT01856270|Primary|Frequency of Headaches|Number of subjects reporting an average of at least one headache per week|90 days|The two arms are combined for this analysis to answer the question of frequency of headache at the 3 month outcome data point and only difference between arms was related to onset time of medication which was not expected to result in significant change in headache frequency, but only potentially in cognitive status.|||Participants|||Count of Participants
1345866|NCT01856257|Secondary|Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure|Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.|Within 24 Hours of transplant procedure|Intent-to-treat population|||Participants|||Count of Participants
1345867|NCT01856257|Secondary|Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events|Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345868|NCT01856257|Secondary|Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant|Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345869|NCT01856257|Secondary|Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant|Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345871|NCT01856257|Secondary|Count of Participants With Graft Rejection by Wk 52 Post-Transplant|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345872|NCT01856257|Secondary|Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant|This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345873|NCT01856257|Secondary|Total Daily Prescribed Pill Count|This is a measure of the total number of pills a participant was prescribed on a given day|Day 28, Day 84, Week 28, Week 36, and Week 52|Intent-to-treat population with available data|||pills per day||Standard Deviation|Mean
1345874|NCT01856257|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.|Baseline (Pre-Transplant), Week 28, and Week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
1345875|NCT01856257|Secondary|Fasting Lipid Profile at Wk 52 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 52|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
1345876|NCT01856257|Secondary|Fasting Lipid Profile at Wk 28 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 28|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
1345877|NCT01856257|Secondary|Fasting Lipid Profile at Baseline (Pre-Transplant)|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Baseline|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
1345878|NCT01856257|Secondary|Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stroke and myocardial infarction.|Week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
1345879|NCT01856257|Secondary|Standardized Blood Pressure Measurement at Wk 52 Post-Transplant|"A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.~Systolic measures of <120 and diastolic measures of <80 are considered normal.~Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).~Systolic measures of ≥140 and diastolic measures of ≥90 are considered high."|Week 52|Intent-to-treat population with available data|||mmHg||Standard Deviation|Mean
1345880|NCT01856257|Secondary|Hemoglobin A1c (HbA1c) Measurements Over Time|"Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:~A value below 6.0% reflects normal levels,~6.0% to 6.4% reflects prediabetes, and~a value of ≥ 6.5% reflects diabetes."|Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant|Intent-to-treat population with available data|||percentage||Standard Deviation|Mean
1345881|NCT01856257|Secondary|Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant|Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.|Day 14 through week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
1345882|NCT01856257|Secondary|Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO|"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.~Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)."|Transplantation through Week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
1345883|NCT01856257|Secondary|Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant|"The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti donor HLA antibodies may mean a person is more likely to reject the graft.~No data available."|Week 52|No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.||||||
1345884|NCT01856257|Secondary|Type of Treatment for Detected Graft Rejection|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of treatment are presented here for rejection. Acronyms and abbreviations are defined below.~ATG=Thymoglobulin"|Transplantation through Week 52|Intent-to-treat population|||Biopsy|||Number
1345885|NCT01856257|Secondary|Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows:~ACR= Acute T-Cell Mediated rejection~AMR= Acute Antibody-mediated rejection~Chr. AMR=Chronic Antibody Mediated Rejection~Gd.=Grade~IFTA=Interstitial Fibrosis and Tubular Atrophy"|Transplantation through Week 52|Intent-to-treat population|||Biopsy|||Number
1345886|NCT01856257|Secondary|Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant|Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345887|NCT01856257|Secondary|Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant|Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally it was 2 endpoints but all participants’ highest grade was also their first grade so only reporting their first grade.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345888|NCT01856257|Secondary|Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant|Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345889|NCT01856257|Secondary|Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant|Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345890|NCT01856257|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or endstage kidney failure.~An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.~Larger numbers indicate greater change in kidney function."|Day 28 through Week 52 Post-Transplant|Intent-to-treat population with available data|||eGFR change over time (by month)||Standard Deviation|Mean
1345891|NCT01856257|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate severe or endstage kidney failure."|Week 52|Intent-to-treat population with available data|||mL/min/1.73m^2||Standard Deviation|Mean
1345892|NCT01856257|Secondary|Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant|"The stages of Chronic Kidney Disease (CKD) are defined using the participant’s GFR value:~Stage 1 if GFR value is ≥ 90 (kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 <= GFR < 60*~Stage 3B if 30 <= GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A abd 3B indicate moderately reduced kidney function.*"|Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345893|NCT01856257|Secondary|Count of Participants by CKD Stage at Wk 52|"The stages of Chronic Kidney Disease are defined using the participant’s GFR value:~Stage 1 if GFR value is ≥90 ( kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 ≤ GFR < 60*~Stage 3B if 30 ≤ GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A and 3B indicate moderately reduced kidney function.*"|Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345894|NCT01856257|Secondary|Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52|Intent-to-treat population|||Participants|||Count of Participants
1345896|NCT01856257|Primary|Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52|Intent-to-treat population with available data at week 52|||mL/min/1.73m^2||Standard Deviation|Mean
1345897|NCT01856218|Secondary|Change From Baseline at Week 36 in Shoulder Range of Motion (Goniometry)|The maximum passive shoulder range of motion in both flexion and extension will be measured in degrees using a goniometer.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
1345898|NCT01856218|Secondary|Change From Baseline at Week 36 in Growth Velocity for Height and Weight|Growth velocity (for males ≤18 years and females ≤15) was calculated from anthropometric measurements and compared with pretreatment growth velocity when available. Z-scores and percentiles were calculated using Centers for Disease Control (CDC) growth chart.|Baseline, Week 36|Summary analyses for all 3 participants combined are not available. Due to the very small number of participants, formal statistical analyses were not performed; and data were presented per participant, which has the potential for participant re-identification given the rarity of disease and the very small population size.||||||
1345899|NCT01856218|Secondary|Change From Baseline at Week 36 in Pulmonary Function Testing (Spirometry)|The following spirometry tests were administered to participants who did not require invasive ventilatory support or have a tracheostomy in accordance with American Thoracic Society/European Respiratory society (ATS/ERS) guidelines: forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), maximum voluntary ventilation in one minute (MVV1). Invasive ventilation is defined as any form of ventilatory support applied with the use of an endotracheal tube.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
1345900|NCT01856218|Secondary|Change From Baseline at Week 36 in the 3-Minute Stair Climb Test (3MSCT)|The number of stairs climbed within a 3-minute period was assessed once each test day using available hospital stairs. Participants who could not climb stairs could omit this test.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
1345901|NCT01856218|Secondary|Percent of Predicted Normal Distance Walked|The percent of predicted normal distance walked (based on published normative data) in the total distance walked in a six-minute period.|36 Weeks|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
1345902|NCT01856218|Secondary|Change From Baseline at Week 36 in Six-Minute Walk Test (6MWT)|The total distance walked (meters) in a 6-minute period was measured once each test day. The test was conducted using a pre-measured walking course according to administration guidelines established by the American Thoracic Society (ATS 2002). Participants who could not walk could omit this test.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
1345903|NCT01856218|Secondary|Acceptable Dose as Determined by Total uGAG Excretion Using a Forced Dose Titration Regimen|The choice of the dose of UX003 QOW for the Long-Term Extension Phase was based on a preliminary efficacy analysis at Week 36 prior to all 3 participants completing the Forced-dose Titration Period of the First Phase of the study.|Week 36||||mg/kg|||Number
1345904|NCT01856218|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Study/Treatment Discontinuations|Adverse Event (AE): any untoward medical occurrence in a subject, whether or not considered drug related. SAE: an AE or suspected adverse reaction that at any dose results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect. Other important medical events may also, in the opinion of the Investigator, be considered SAEs. An AE was considered a TEAE if it occurred on or after the first dose, and was not present prior to the first dose, or it was present at the first dose but increased in severity during the study. Events recorded as either possibly, probably, or definitely related to treatment were categorized as related. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.03.|Up to 242 weeks + 30 days. SAEs were recorded beginning at the time the subject signed the informed consent form through 30 days following the last study visit. Non-serious AEs were recorded from the time of informed consent through the last study visit.||||participants|||Number
1345905|NCT01856218|Primary|Number of Participants With Any ≥ 50% Decrease in uGAG|Participants with a ≥ 50% decrease in the concentration of uGAGs normalized to the urinary creatinine concentration as measured by liquid chromatography-mass spectrometry/mass spectrometry-dermatan sulfate or chondroitin sulfate.|up to Week 132||||Participants|||Count of Participants
1345906|NCT01856218|Primary|Percentage Change From Baseline in uGAG Chondroitin Sulfate|Percentage change from baseline in the concentration of uGAGs normalized to the urinary creatinine concentration as measured by liquid chromatography-mass spectrometry/mass spectrometry-chondroitin sulfate.|Baseline, Week 14, Week 22, Week 30, Week 38, Week 72, and end of study (up to Week 132)||||percentage change||Standard Deviation|Mean
1345907|NCT01856218|Primary|Percentage Change From Baseline in Urinary Glycosaminoglycan (uGAG) Dermatan Sulfate|Percentage change from baseline in the concentration of uGAGs normalized to the urinary creatinine concentration as measured by liquid chromatography-mass spectrometry/mass spectrometry-dermatan sulfate.|Baseline, Week 14, Week 22, Week 30, Week 38, Week 72, and end of study (up to Week 132)||||percentage change||Standard Deviation|Mean
1345908|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.|||participants|||Number
1345909|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|CN Population.|||participants|||Number
1345910|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.|||participants|||Number
1345911|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||participants|||Number
1345912|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|CN Population.|||participants|||Number
1345913|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|GT Population.|||participants|||Number
1345914|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||participants|||Number
1345915|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||participants|||Number
1345916|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|GT Population.|||participants|||Number
1345917|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.|||participants|||Number
1345918|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.|||participants|||Number
1345919|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.|||participants|||Number
1345969|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.|Day 183 and Day 366 post vaccination|Analysis was done on the full analysis set.|||Percentages of Subjects||95% Confidence Interval|Number
1345920|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population.|||participants|||Number
1345921|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||participants|||Number
1345922|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||participants|||Number
1345923|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||participants|||Number
1345924|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||participants|||Number
1345925|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||participants|||Number
1345926|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345927|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345928|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.|||beta coefficient|||Number
1345929|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.|||beta coefficient|||Number
1345930|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345931|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345932|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.|||beta coefficient|||Number
1345933|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.|||beta coefficient|||Number
1345934|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345935|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345936|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||beta coefficient|||Number
1347204|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 6 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 6 compared to Month 3|3 Months and 6 months||||Participants|||Count of Participants
1345937|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||beta coefficient|||Number
1345938|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.|||beta coefficient|||Number
1345939|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Genetic Data Quality Check (GT) Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check.|||beta coefficient|||Number
1345940|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345941|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
1345942|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||beta coefficient|||Number
1345943|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||beta coefficient|||Number
1345944|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.|||beta coefficient|||Number
1345945|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check.|||beta coefficient|||Number
1345946|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.|||beta coefficient|||Number
1345947|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||beta coefficient|||Number
1345948|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.|||beta coefficient|||Number
1345949|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||beta coefficient|||Number
1345950|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||beta coefficient|||Number
1346045|NCT01854697|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1345951|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||beta coefficient|||Number
1345952|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||beta coefficient|||Number
1345953|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model|GWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||beta coefficient|||Number
1345954|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||beta coefficient|||Number
1345955|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check.|||beta coefficient|||Number
1345956|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||beta coefficient|||Number
1345957|NCT01855997|Primary|Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model|Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to haplotype map (HapMap) version 3.0 reference individuals.|||beta coefficient|||Number
1347205|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 3 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 3 compared to previous visit.|Baseline and 3 months||||Participants|||Count of Participants
1345958|NCT01855958|Primary|Conditioned Pain Modulation (CPM) After Intervention.|"PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject.~# Below the data after intervention."|Before and within one hour after intervention.||||Kgf / cm2||Standard Deviation|Mean
1345959|NCT01855958|Secondary|Cortical Silent Period (CSP) After Intervention.|"To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject.~# Below the data after intervention."|Evaluated before and within one hour after intervention.||||ms (milliseconds).||Standard Deviation|Mean
1345960|NCT01855958|Secondary|Intracortical Facilitation (ICF) After Intervention.|"ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP.~# Below the data after intervention."|Before and within one hour after intervention.||||ratio of amplitude (mV).||Standard Deviation|Mean
1345961|NCT01855958|Primary|Motor Evoked Potential (MEP) After Intervention.|"Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag–AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was deﬁned as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials.~MEP was deﬁned as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP).~# Below the data after intervention."|Before and within one hour after intervention.||||mV (millivolts).||Standard Deviation|Mean
1345962|NCT01855958|Primary|Pain Pressure Threshold (PPT) After Intervention..|"PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes.~# Below, the data after intervention."|Before and within one hour after intervention.||||Kgf / cm2||Standard Deviation|Mean
1345963|NCT01855958|Secondary|Pain Intensity After Intervention.|"The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm).~# Below the data after intervention."|Evaluated within twenty four hours before and within one hour after the intervention.||||cm ( mean).||Standard Deviation|Mean
1345964|NCT01855958|Secondary|Intracortical Inhibition (ICI) After Intervention.|"ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP.~# Below the data after intervention."|Evaluated in one day. The cortical excitability before and within an hour after intervention.||||ratio of amplitude (mV).||Standard Deviation|Mean
1345965|NCT01855945|Secondary|GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.|Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.|||Ratios||95% Confidence Interval|Geometric Mean
1345966|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
1345967|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
1345968|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years.~Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
1345970|NCT01855945|Secondary|Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.|Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.|||Ratios||95% Confidence Interval|Geometric Mean
1345971|NCT01855945|Secondary|Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).|The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.|Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination|Analysis was done on Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1345972|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.~Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
1345973|NCT01855945|Primary|Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|"The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported.~The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported."|Day 1 through Day 366|Analysis was done on unsolicited safety dataset i.e. all subjects in the exposed population who have post-vaccination unsolicited adverse event records.|||Number of subjects|||Number
1345974|NCT01855945|Primary|Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
1345975|NCT01855945|Primary|Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
1345976|NCT01855945|Primary|Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
1345977|NCT01855945|Primary|Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
1345978|NCT01855919|Secondary|Percentage of Participants With Fall Events in Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1345979|NCT01855919|Secondary|Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.|||percentage of participants|||Number
1345980|NCT01855919|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14|WPAI is a self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores: Absenteeism (work time missed)=Question (Q)2/(Q2+4))*100); Presenteeism (impairment at work/reduced on-the-job effectiveness)=(Q5/10)*100); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100); and Activity Impairment=(Q6/10)*100. Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||hours||Standard Error|Least Squares Mean
1346058|NCT01854645|Secondary|Peak Change From Baseline in FEV1 Within 2 Hours Post-dose|Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
1345981|NCT01855919|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3 level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF.|||units on a scale||Standard Error|Least Squares Mean
1345982|NCT01855919|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14|SF-36 Health Status Survey is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1345983|NCT01855919|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14|BDI-II is a 21-question multiple-choice self-reported inventory about depressive symptoms (sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping patterns, irritability, changes in appetite, concentration difficulties, tiredness or fatigue, and loss of interest in sex). The scores for each item range from 0 (best) to 3 (worst) with possible total scores of 0 to 63, where higher total scores indicate more severe depressive symptoms. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1345984|NCT01855919|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
1345985|NCT01855919|Secondary|Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10(worst pain) to determine average pain in the past 24 hours (average pain). Participants were considered to have sustained pain reduction of ≥30% in the BPI-severity score (average pain) at the time of final evaluation and at least 1 other time point prior to the time of final evaluation compared with baseline, and a reduction of ≥20% from baseline sustained at all evaluation time points between that period. Percentage of participants = (number of participants with sustained pain reduction / total number of participants in treatment group) * 100.|Baseline through Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||percentage of participants|||Number
1345986|NCT01855919|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||percentage of participants|||Number
1345987|NCT01855919|Secondary|Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. For the analysis, weekly mean was calculated. LS means calculated using MMRM adjusted for treatment, week, interaction between treatment and week as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
1345988|NCT01855919|Secondary|Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores range from: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores range from: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference is defined as the average of non-missing scores of individual interference items. Higher scores indicated worsening of pain. LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
1346059|NCT01854645|Secondary|Onset of Action as Assessed by FEV1|Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant|Assessed for 5- and 15-minute post dose on Day 1|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
1345989|NCT01855919|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14|The RMDQ-24 is a health status measure completed by participants to assess physical disability due to low back pain. Participants answered 24 questions about impairment of daily living activities (standing, walking, sitting, wearing clothes, working, etc.) resulting from low back pain. The number of statements marked was summed by the clinician for a total score. The total scores range from 0 (no disability) to 24 (severe disability). LS means calculated using analysis of covariance (ANCOVA) with treatment group as a fixed effect, and baseline value as a covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
1345990|NCT01855919|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 14|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
1345991|NCT01855919|Primary|Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
1345992|NCT01855789|Secondary|Mean Soluble Interleukin-6 (IL-6) Receptor Concentration||Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)|Analysis was performed on safety population. The analysis included overall study population and was not intended to compare the 2 randomized groups. ‘Number Analyzed’ = number of participants with assessment at specified time points.|||nanograms per milliliter||Standard Deviation|Mean
1345993|NCT01855789|Secondary|Mean TCZ Serum Concentration||Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)|Analysis was performed on safety population. The analysis included overall study population and was not intended to compare the 2 randomized groups. ‘Number Analyzed’ = number of participants with assessment at specified time points.|||micrograms per milliliter||Standard Deviation|Mean
1345994|NCT01855789|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TCZ|Percentage of participants with positive results for ATA against TCZ at Baseline and at any of the post-baseline assessment time-points was reported. Participants positive at any post-baseline time points were participants who had no positivity at baseline for the same assay.|Baseline, Post-baseline (assessed at Weeks 12, 24, 36, 52 and at follow up [Week 60])|Analysis was performed on safety population which included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. The analysis included overall study population and was not intended to compare the 2 randomized groups. ‘Number Analyzed’ = participants with ATA assessment at specified time points.|||percentage of participants|||Number
1345995|NCT01855789|Secondary|Change From Week 24 in Bone Erosion Score at Week 40 for Participants in the Magnetic Resonance Imaging (MRI) Substudy|Bones from the wrist regions (carpal bones, distal radius, distal ulna, and metacarpal bases) and the metacarpophalangeal (MCP) joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranged from 0 (no erosion) to 10 (91-100%). Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value for change from Week 24 in bone erosion score indicated an improvement.|Weeks 24, Week 40|Analysis was performed on MRI subset which included all participants in the randomized group who passed MRI eligibility requirements and who had an MRI performed on or after the Week 24 visit. Here, ‘Number Analyzed’ signifies participants with assessment at specified time point.|||units on a scale||Standard Deviation|Mean
1345996|NCT01855789|Secondary|Percentage of Participants With DAS28 Score </=3.2 (Low DAS28)|The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28­ESR score could range from 0 to 10, where higher score represented higher disease activity.|Week 40, Week 52|Analysis was performed on randomized group. Missing assessments of DAS28 were treated as no response.|||percentage of participants|||Number
1345997|NCT01855789|Secondary|Percentage of Participants With DAS28 Score <2.6 (DAS28 Remission)|The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity.|Week 40, Week 52|Analysis was performed on randomized group. Missing assessments of DAS28 were treated as no response.|||percentage of participants|||Number
1345998|NCT01855789|Secondary|Percentage of Participants With >/=1.2 Points Increase (Worsening) From Week 24 in DAS28 Score at Week 40 and 52|The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28­ score could range from 0 to 10, where higher score represented higher disease activity.|Week 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of DAS28 were treated as worsening.|||percentage of participants|||Number
1346060|NCT01854645|Secondary|Rescue Ventolin Hydrofluoroalkane (HFA) Use|Change from baseline in average daily rescue Ventolin HFA use|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Puffs / Day||95% Confidence Interval|Least Squares Mean
1345999|NCT01855789|Secondary|Percentage of Participants Achieving 70% Improvement in American College of Rheumatology (ACR70) Response|The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).|Weeks 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of response were treated as no response.|||percentage of participants|||Number
1346000|NCT01855789|Secondary|Percentage of Participants Achieving 50% Improvement in American College of Rheumatology (ACR50) Response|The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).|Weeks 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of response were treated as no response.|||percentage of participants|||Number
1346001|NCT01855789|Secondary|Percentage of Participants Achieving 20% Improvement in American College of Rheumatology (ACR20) Response|The ACR20 response at any time was defined as >/=20% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein [CRP] in milligrams per deciliter [mg/dL]).|Weeks 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of response were treated as no response.|||percentage of participants|||Number
1346002|NCT01855789|Primary|Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40|The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100­-millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.|Week 24, Week 40|Analysis was performed on randomized group which included participants in ITT population who were randomized and received blinded treatment at Week 24. Missing Week 40 values were imputed using last available assessment obtained after Week 24. Here, ‘Number Analyzed’ signifies number of participants with assessment at specified time point.|||units on a scale||Standard Deviation|Mean
1346003|NCT01855425|Primary|Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale|"Percentage of Participants with >=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients.~Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes."|11 months|96 participants were imaged for this study, but only 76 participant image pairs were analyzed in the reader study. 20 participant image pairs were disqualified by the physicians due movement/unclear image quality.|||percentage of participants||Standard Deviation|Mean
1346004|NCT01855074|Secondary|Extrapyramidal Symptom Rating Scale (ESRS) Score|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, absent) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 26|Safety set (SS) population (N=79) included all participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1346005|NCT01855074|Secondary|Patient Satisfaction With Treatment|Participants’ were assessed for their satisfaction with the current antipsychotic treatment on a 5-point scale/questionnaire: very good, good, reasonable, moderate or poor.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Participants|||Number
1346006|NCT01855074|Secondary|Global Assessment of Functioning (GAF) Score|The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
1346007|NCT01855074|Secondary|Short Form-36 (SF-36) - Quality of Life Score|The SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: vitality, physical function, social function, physical role, emotional role, bodily pain, general health, mental health. Each item is scored on a scale ranging from 0-100 (100=highest level of functioning).|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
1346008|NCT01855074|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
1346009|NCT01855074|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. Change at Week 26 score is calculated as Baseline score minus Week 26 score.|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
1346010|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1346011|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation."|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1346012|NCT01854944|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1346013|NCT01854944|Secondary|Mean Change From Baseline in PANNS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1346014|NCT01854944|Secondary|Mean Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety sample included participants that are administered at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1346015|NCT01854944|Secondary|Percentage of Participants Who Reported at Least One Occurrence of Suicidality, Suicidal Behavior and Suicidal Ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25, with a higher score indicating a worse outcome. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale. Last Visit is last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Last Visit|The safety population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
1346016|NCT01854944|Secondary|Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The BARS total score (when combined) ranged from 0 to 18, with higher values indicating a severe condition.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1346017|NCT01854944|Secondary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40, with higher scores indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on scale||Standard Deviation|Mean
1346018|NCT01854944|Secondary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, with a higher score indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1346019|NCT01854944|Secondary|Time to Maximum (Peak) Plasma Concentration (Tmax) for Brexpiprazole and Its Metabolite DM-3411|Tmax for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.|||hour||Full Range|Median
1346020|NCT01854944|Secondary|Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F; Only Brexpiprazole)|PK parameter - CL/F was assessed for brexpiprazole only. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.|||mL/hr||Standard Deviation|Mean
1346021|NCT01854944|Secondary|Peak (Maximal) Concentration of Drug in Plasma (Cmax) for Brexpiprazole and Its Metabolite DM-3411|(Cmax) Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.|||ng/mL||Standard Deviation|Mean
1346022|NCT01854944|Secondary|Area Under the Concentration-time Curve (AUCτ) During a Dosing Interval at Steady-state for Brexpiprazole and Its Metabolite DM-3411|AUC during a dosing interval at steady-state for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at early termination (ET).|||hr*ng/mL||Standard Deviation|Mean
1346023|NCT01854944|Primary|Change in Occupancy at Serotonin Transporter (SERT)|Mean (±SD) SERT Occupancy Using the Radiotracer [11C]DASB in high dose only. Occupancy estimates were averaged across brain regions 4 hours post-last dose.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
1346024|NCT01854944|Primary|Change in Percentage 5-HT2A Receptor Occupancy|Mean (±SD) Serotonin 5-HT2A Receptor Occupancy Using the Radiotracer [11C]MDL100907 (in low and high dose). The 5-HT2A receptors following administration of 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline and 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
1346025|NCT01854944|Primary|Change in Percentage 5-HT1A Receptor Occupancy|Mean (±SD) Serotonin 5-HT1A Receptor Occupancy Using the Radiotracer [11C]CUMI101 in high dose only. In cohorts 1, 2 and 3, the binding of brexpiprazole to the 5-HT1A receptors was assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The 5-HT1A receptors following administration of a 4-mg dose of brexpiprazole was assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
1350553|NCT01790178|Primary|Number of Patients Receiving Diagnosis From Muscle Biopsy|The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.|At time of biopsy||||participants|||Number
1346026|NCT01854944|Primary|Change in Percentage Dopamine D2/D3 Receptor Occupancy|Dopamine receptor occupancy measured using the radiotracer [11C]-(+)-PHNO in low and high dose. The binding of brexpiprazole to the D2/D3 receptors were assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The D2/D3 receptors following administration of a 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The positron emission tomography (PET) analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
1346027|NCT01854905|Primary|Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale|The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress|Day 1|All enrolled patients|||Percentage of Patients|||Number
1346028|NCT01854827|Secondary|Circulating Regulatory T-Cells, Inflammatory Cytokines, and Specific Autoantibodies.|Percentage and absolute number of Tregs (CD4+CD25+FoxP3+), CD3/4 T cells, CD3/8 T cells, NK cells (CD56), NK T cells (CD3/56), CD19/20 B cells, macrophages (CD14/11b), and neutrophils; plasma levels of anti-enolase antibody; and plasma cytokine levels (Th1/Th2 multiplex and IL17)|Over 360 days after HPE||2018-05-31|05/2018||||
1346029|NCT01854827|Secondary|Transplant-free Survival|Percentage of subjects who survive with their native liver at 360 days after HPE.|360 days post-HPE|mITT|||Participants|||Count of Participants
1346030|NCT01854827|Secondary|Good Bile Drainage at 360 Days Post-HPE|Percentage of subjects who survive 360 days after HPE with both their native liver and serum total bilirubin <1.5 mg/dL at 360 days after HPE|360 days post-HPE|mITT|||Participants|||Count of Participants
1346031|NCT01854827|Secondary|Good Bile Drainage at 180 Days Post-HPE|Percentage of subjects who survive 180 days after HPE with both their native liver and serum total bilirubin <1.5 mg/dL at 180 days after HPE|180 days post-HPE|mITT|||Participants|||Count of Participants
1346032|NCT01854827|Secondary|Good Bile Drainage at 90 Days Post-HPE|Percentage of subjects who survive 90 days after HPE with both their native liver and serum total bilirubin <1.5 mg/dL at 90 days after HPE|90 days post-HPE|mITT|||Participants|||Count of Participants
1346033|NCT01854827|Primary|Adverse Events|Percentage of subjects with other expected adverse events|360 days post-HPE|mITT|||Participants|||Count of Participants
1346034|NCT01854827|Primary|Level 3-5 Toxicity|Percentage of subjects with any level 3, 4, or 5 toxicity (per NCI CTEP grading system)|360 days post-HPE|mITT|||Participants|||Count of Participants
1346035|NCT01854827|Primary|Serious Adverse Events|Percentage of subjects with any serious adverse events (SAEs) prior to liver transplant|360 days post-HPE|mITT|||Participants|||Count of Participants
1346036|NCT01854827|Primary|Acceptability of IVIG|Percentage of subjects for whom the study is acceptable, defined as the ability of the subject's family or guardian to allow intravenous line placements, blood draws, and other study procedures for the study subjects.|60 days post-HPE|MITT|||Participants|||Count of Participants
1346037|NCT01854827|Primary|Feasibility of IVIG Treatment|Percentage of subjects for whom administration of IVIG is feasible, defined as the successful administration (at least 80% of each dose) of all 3 doses of IVIG|60 days post-HPE|MITT|||Participants|||Count of Participants
1346038|NCT01854710|Other Pre-specified|Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)|A thorough QT/QTc study may be considered to have demonstrated assay sensitivity if 1 or more of the lower 95% CI values exceeds 5 msec|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between moxifloxacin and placebo exposures per ICH Guideline E14 for a thorough QT study.|||msec||95% Confidence Interval|Least Squares Mean
1346039|NCT01854710|Secondary|Subjects With QTcI Increase > 60 ms From Baseline|Numbers of Subjects with QTcI Increase > 60 ms From Baseline at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
1346040|NCT01854710|Secondary|Subjects With QTcI Increase > 30 ms From Baseline|Numbers of Subjects with QTcI Increase > 30 ms from Baseline at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
1346041|NCT01854710|Secondary|Subjects With QTcI > 480 ms|Numbers of Subjects with QTcI > 480 ms (or 500 ms) at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
1346042|NCT01854710|Secondary|Subjects With QTcI > 450 ms|Numbers of Subjects with QTcI > 450 ms at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
1346043|NCT01854710|Secondary|QTc Versus Loxapine Concentration|QTc @ Cmax based on linear and nonlinear regression of QTcI versus time matched serum loxapine concentrations|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between Adasuve and placebo exposures per ICH Guideline E14 for a thorough QT study.|||msec||95% Confidence Interval|Least Squares Mean
1346044|NCT01854710|Primary|Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo|Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for ADASUVE treatment at 12 post-inhalation times.|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between Adasuve and placebo exposures per ICH Guideline E14 for a thorough QT study.|||msec||95% Confidence Interval|Least Squares Mean
1346046|NCT01854697|Secondary|Percentage of Participants With Post-treatment Relapse|Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment.|Within 24 weeks post treatment|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and had sustained virologic response at Week 24 (SVR24).|||percentage of participants|||Number
1346047|NCT01854697|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:~Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment~Failure to achieve HCV RNA < LLOQ by Week 6 or~Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.~Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:~HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV~HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV~Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV~Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV."|12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1346048|NCT01854697|Secondary|Percentage of Participants With SVR12 - Secondary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1346049|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)|SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.|||units on a scale||Standard Deviation|Mean
1346050|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)|SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.|||units on a scale||Standard Deviation|Mean
1346051|NCT01854697|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1346052|NCT01854658|Secondary|Onset of Action as Assessed by FEV1|Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant|Day 1|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
1346053|NCT01854658|Secondary|Rescue Ventolin HFA Use|Change from baseline in average daily rescue Ventolin HFA use over 24 weeks|24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Puffs / Day||95% Confidence Interval|Least Squares Mean
1346054|NCT01854658|Secondary|St. George Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ total score at Week 24. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1346055|NCT01854658|Secondary|Peak FEV1|Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24|At week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
1346056|NCT01854658|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Over 24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
1346057|NCT01854658|Primary|Change From Baseline in Morning Pre-dose Trough FEV1|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.|At Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
1346061|NCT01854645|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1346062|NCT01854645|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Baseline and Weeks 2 to 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
1346063|NCT01854645|Primary|Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
1346064|NCT01854632|Secondary|Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection|Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.|Through 4 days post vaccination|||||||
1346065|NCT01854632|Secondary|Etiologies of Influenza-like Illness in the Study Population|Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.|Through 7 to 8 months post vaccination|||||||
1346066|NCT01854632|Secondary|Clinical Characteristics of Influenza in the Study Population||Through 7 to 8 months post vaccination|||||||
1346067|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)||Through 7 to 8 months post vaccination|||||||
1346068|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains)||Through 7 to 8 months post vaccination|||||||
1346069|NCT01854632|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 8 months post vaccination|||||||
1346070|NCT01854632|Secondary|Safety Profile of LAIV: Other Non-serious Adverse Events||Through 1 month post vaccination|||||||
1346071|NCT01854632|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 1 month post vaccination|||||||
1346072|NCT01854632|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through 7 days post vaccination|||||||
1346073|NCT01854632|Secondary|Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.||Through 30 minutes post vaccination|||||||
1346074|NCT01854632|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)||Through 7 to 8 months post vaccination|All participants meeting per-protocol analysis criteria.|||percentage of participants|||Number
1346075|NCT01854593|Secondary|Silicon Oil Tamponade|The number of participants with silicon oil tamponade at the end of the surgery.|End of surgery.||||participants|||Number
1346076|NCT01854593|Secondary|Gas Tamponade|The number of participants with gas tamponade at the end of the surgery.|End of surgery.||||participants|||Number
1346077|NCT01854593|Secondary|Elevated Intraocular Pressure|The number of participants with elevated intraocular pressure after surgery.|Within 1 month after the surgery.||||participants|||Number
1346078|NCT01854593|Secondary|Postoperative Neovascular Glaucoma|The number of participants with progressive or persistent neovascular glaucoma after surgery.|Within 1 month after the surgery.||||participants|||Number
1346079|NCT01854593|Secondary|Best Corrected Visual Acuity Change|"Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.~The higher values represent a worse outcome."|1 month||||LogMAR||Standard Deviation|Mean
1346080|NCT01854593|Secondary|Postoperative Best Corrected Visual Acuity|"Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.~The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome."|1 mouth after surgery.||||LogMAR||Standard Deviation|Mean
1346081|NCT01854593|Secondary|Surgical Time||End of surgery.||||minutes||Standard Deviation|Mean
1346082|NCT01854593|Secondary|Iatrogenic Retinal Tears|The number of participants who had intraoperative iatrogenic retinal tears.|End of surgery.||||participants|||Number
1346083|NCT01854593|Secondary|Endolaser Photocoagulation|Number of intraoperative endolaser photocoagulation.|End of surgery.||||photocoagulation||Standard Deviation|Mean
1346084|NCT01854593|Secondary|Vascular Endothelial Growth Factor Concentration in Vitreous|Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.|Start of surgery.||||μg/ml||Standard Deviation|Mean
1346085|NCT01854593|Primary|Reoperation|Vitreoretinal reoperation due to recurrent vitreous hemorrhage.|1 month||||participants|||Number
1346086|NCT01854593|Secondary|Postoperative Vitreous Hemorrhage.|Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.|1 month||||participants|||Number
1346087|NCT01854593|Secondary|Intra Operative Hemorrhage|Calculate the number of coagulators for the intra operative hemorrhage.|End of the surgery.||||coagulators||Standard Deviation|Mean
1346088|NCT01854528|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1346089|NCT01854528|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment.|Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1346090|NCT01854528|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|24 weeks after the last dose of study drug|All participants in the ITT population with evaluable data.|||percentage of participants|||Number
1346091|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey – Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1346092|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey – Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1346093|NCT01854528|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last dose of study drug|ITT population: All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1346094|NCT01854281|Primary|Arterial Nitrogen Bubbles After Surfacing|Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.|assesed within 1 hour after surfacing||||participants|||Number
1346095|NCT01854268|Secondary|Urge-to-cough|Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).|1 hour||||units on a scale||Standard Error|Median
1346096|NCT01854268|Secondary|Peak Expiratory Airflow Rate|Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second.|1 hour||||Liters/second||Standard Deviation|Mean
1346097|NCT01854268|Primary|Lung Volume Initiation|Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.|1 hour|25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease.|||% Vital Capacity, relative to EEL||Standard Deviation|Mean
1346098|NCT01854242|Primary|Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease|Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table.|2 weeks||||participants testing positive|||Number
1346099|NCT01854138|Secondary|Number of Participants With Hematoma||60 days||||Participants|||Count of Participants
1346100|NCT01854138|Secondary|Number of Participants With Seroma||60 days||||Participants|||Count of Participants
1346101|NCT01854138|Secondary|Number of Participants With Infection||60 days||||Participants|||Count of Participants
1346102|NCT01854138|Primary|Number of Participants With Hospital Readmissions||60 days||||Participants|||Count of Participants
1346103|NCT01854047|Post-Hoc|Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on subset of ITT population which included participants with baseline blood eosinophil count <0.3 G/L.|||liter||Standard Deviation|Mean
1346104|NCT01854047|Secondary|Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population|Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.|Baseline, Week 12|ITT population.|||inhalations per day||Standard Deviation|Mean
1346105|NCT01854047|Secondary|Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population|Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.|Baseline, Week 12|HEos-ITT Population.|||inhalations per day||Standard Deviation|Mean
1346106|NCT01854047|Secondary|Change From Baseline in AQLQ Global Score at Week 12: ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
1346107|NCT01854047|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 12|HEos-ITT population.|||scores on a scale||Standard Deviation|Mean
1346108|NCT01854047|Secondary|Change From Baseline in ACQ-5 Score at Week 12: ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
1346109|NCT01854047|Secondary|Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Week 12|HEos-ITT population.|||scores on a scale||Standard Deviation|Mean
1346110|NCT01854047|Secondary|Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population|Evening asthma symptom score was determined using PM symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
1346111|NCT01854047|Secondary|Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population|Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|HEos ITT population.|||scores on a scale||Standard Deviation|Mean
1346112|NCT01854047|Secondary|Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population|Morning asthma symptom score was determined using AM symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
1346113|NCT01854047|Secondary|Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population|Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant’s overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|HEos-ITT population.|||scores on a scale||Standard Deviation|Mean
1346114|NCT01854047|Secondary|Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population|The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.|||probability of LOAC||95% Confidence Interval|Number
1346126|NCT01854034|Secondary|Exon 20 EGFR Mutations Among Participants That Responded to Treatment|"The specific exon 20 epidermal growth factor receptor (EGFR) mutations among participants that achieved either a partial response or complete response as assessed by RECIST. The EGFR mutations were assessed from biopsies taken at baseline and then the baseline mutations were categorized by disease response.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Baseline, at the time of response||||participants|||Number
1346115|NCT01854047|Secondary|Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population|The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||probability of LOAC||95% Confidence Interval|Number
1346116|NCT01854047|Secondary|Annualized Event Rate of LOAC During The Treatment Period: ITT Population|LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.|||LOAC per participant-year||95% Confidence Interval|Number
1346117|NCT01854047|Secondary|Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population|LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in inhaled corticosteroid (ICS) >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||LOAC per participant-year||95% Confidence Interval|Number
1346118|NCT01854047|Secondary|Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population|The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of ITT population who were treated.|||probability of Severe Exacerbation||95% Confidence Interval|Number
1346119|NCT01854047|Secondary|Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population|The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||probability of Severe Exacerbation||95% Confidence Interval|Number
1346120|NCT01854047|Secondary|Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.|||exacerbation per participant-year||95% Confidence Interval|Number
1346121|NCT01854047|Secondary|Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||exacerbation per participant-year||95% Confidence Interval|Number
1346122|NCT01854047|Secondary|Percent Change From Baseline in FEV1 at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1346123|NCT01854047|Secondary|Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|HEos-ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1346124|NCT01854047|Primary|Absolute Change From Baseline in FEV1 at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|ITT population.|||liter||Standard Deviation|Mean
1346125|NCT01854047|Primary|Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|HEos-ITT population: subset of intent to treat (ITT) population (defined as randomized population analyzed according to the treatment group allocated by randomization, regardless of whether the treatment was actually received) which included participants with baseline blood eosinophils >=0.3 G/L.|||liter||Standard Deviation|Mean
1346127|NCT01854034|Secondary|The Number of Participants With Treatment Related Serious Adverse Events|The number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) that were deemed to be possibly, probably, or definitely related to study treatment as determined by the treating physician.|From the start of treatment until 28 days after the end of treatment||||Participants|||Count of Participants
1346128|NCT01854034|Secondary|Median Progression Free and Overall Survival|Overall survival (OS) is measured from the start of treatment until the time of death. Progression free survival is measured from the start of treatment until the time of death or disease progression as assessed by RECIST. Progressive disease is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.|From the start of treatment until the time or death or disease progression||||Months||95% Confidence Interval|Median
1346129|NCT01854034|Primary|Overall Response Rate|"The number of participants that achieved a response to treatment as assessed by Response Evaluation Criteria is Solid Tumors (RECIST). Response is defined as having achieved either a complete response (CR) or a partial response (PR).~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|From the start of treatment until the time of disease progression, median duration of follow-up of about 3 months||||Participants|||Count of Participants
1346130|NCT01853982|Primary|Clinical Response at the End of Therapy Visit||24 hours after last dose of study drug|There is no analysis population or data available for this measure. This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.||||||
1346131|NCT01853839|Secondary|Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)|Number of participants with adverse events in participants receiving Angiotensin II (Type 1) Receptor Blockers (ARBs) when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration.|Up to 52 weeks|All subjects who took a combination of ARB and CCB drugs.|||participants|||Number
1346132|NCT01853839|Secondary|The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at the end of the 1 year treatment duration. This variable was derived from the mean sitting blood pressure assessed by the investigators at the end of the 1 year treatment duration. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. At this timepoint, a diagnosis of diabetes mellitus and/or kidney disease was also taken into account. Subjects with either of the mentioned conditions had to have systolic blood pressure lower than 130 mm Hg and diastolic blood pressure below 80 mm Hg to satisfy JNC 7 treatment goals.|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
1346133|NCT01853839|Secondary|The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in diastolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population|||mmHg||Standard Deviation|Mean
1346134|NCT01853839|Secondary|The Difference in Systolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in systolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population|||mmHg||Standard Deviation|Mean
1346135|NCT01853839|Secondary|Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician)|Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
1346136|NCT01853839|Secondary|Compliance of Patients During the Whole Study Duration (52 Weeks)|"Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|Up to 52 weeks|Per-protocol population including all patients with data at 52 weeks|||Percentage of participants|||Number
1346137|NCT01853839|Secondary|Compliance of Patients up to 10 Days After Ramadan|"Compliance of patients up to 10 days after Ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days after Ramadan|Per-protocol population including all patients with data 10 days after Ramadan|||Percentage of participants|||Number
1346138|NCT01853839|Secondary|Compliance of Patients up to 10 Days Before Ramadan|"Compliance of patients up to 10 days before ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days before Ramadan|Per-protocol population including all patients with data 10 days before Ramadan|||Percentage of participants|||Number
1346139|NCT01853839|Secondary|The Overall Assessment of Treatment by Physicians at 52 Weeks|The overall assessment of treatment by physicians at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
1346140|NCT01853839|Secondary|The Overall Assessment of Treatment by Patients at 52 Weeks|The overall assessment of treatment by patients at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
1346141|NCT01853839|Secondary|Cardiovascular Events|Percentage of participants who experienced a major cardiovascular (CV) event|Up to 52 weeks|All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria|||Percentage of participants|||Number
1346142|NCT01853839|Secondary|Achieving JNC 7 Treatment Goals After Ramadan|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting after Ramadan. This variable was derived from the mean sitting blood pressure assessed by the investigators after Ramadan. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|1 month|Per-protocol (PP) population which included all eligible patients who did not experience any protocol violation and were treated with the study medication up to week 52 (study completers) according to the prescribing information.|||Percentage of participants|||Number
1346143|NCT01853839|Primary|Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at week 52. This variable was derived from the mean sitting blood pressure assessed by the investigators at week 52. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria – systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|Up to 52 weeks|ITT dataset which included all patients, who received at least one dose of study medication.|||Percentage of participants|||Number
1346144|NCT01853696|Secondary|Immunologic Graft Rejection Episode|Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.|within first year after cornea transplantation||||eyes|Participants||Number
1346145|NCT01853696|Primary|Intraocular Pressure|Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.|from 1 to 12 months after transplant||||eyes|Participants||Number
1346146|NCT01853605|Primary|Local Complications|Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.|||Percentage of Subjects||95% Confidence Interval|Number
1346147|NCT01853605|Primary|Investigator Satisfaction With Breast Implants on a 5-Point Scale|Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.|||Subjects|||Number
1346148|NCT01853605|Primary|Subject Satisfaction With Breast Implants on a 5-Point Scale|Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.|||Subjects|||Number
1346149|NCT01853475|Secondary|Piperaquine AUC0-inf|Area under the Piperaquine plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346150|NCT01853475|Secondary|Piperaquine Cmax|Piperaquine maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1346151|NCT01853475|Primary|OZ439 AUC0-inf|Area under the OZ439 plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346152|NCT01853475|Primary|OZ439 Cmax|OZ439 maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1346153|NCT01853397|Secondary|Subject Satisfaction With Treatment|Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater (‘satisfied’ or ‘very satisfied’).|4, 8, 12, and 16 weeks|Intent-to-treat|||percentage of subjects satisfied|||Number
1346182|NCT01853215|Secondary|Stability of Locator|"Operator's perceived stability of the sternal locator once placed on the subject.~1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent."|During insertion of the intraosseous needle set|Per protocol|||Likert scale||Standard Deviation|Mean
1346154|NCT01853397|Secondary|Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of ‘Improved’ or ‘Much Improved’.|4, 8, 12, and 16 weeks|Intent-to-treat|||percentage of subjects improved|||Number
1346155|NCT01853397|Secondary|Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|"GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area.~Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of ‘Improved’ or ‘Much Improved’."|4, 8, 12, and 16 weeks|Intent-to-treat|||Percentage of subjects improved|||Number
1346156|NCT01853397|Secondary|Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.|4 weeks, 8 weeks, 16 weeks|Intent-to-treat|||cm||Standard Deviation|Mean
1346157|NCT01853397|Primary|Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.|12 weeks|Intent-to-treat|||cm||Standard Deviation|Mean
1346158|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||mm||Standard Error|Least Squares Mean
1346159|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||mm||Standard Error|Least Squares Mean
1346160|NCT01853384|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.|Due to study termination the data available to assess durability of closure were limited to only the subjects who completed at least one of the follow-up visits. Participants who had CLOSED wounds at completion of treatment; 103 subjects (HP802-247: 49; Vehicle: 54) completed Visit 18, 114 subjects (HP802-247: 57; Vehicle: 57) completed Visit 19|||participants|||Number
1346161|NCT01853384|Secondary|Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline|For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05|||percentage of participants|||Number
1346162|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier Survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using Kaplan-Meier Survival analysis, with significance being at P < 0.05.|||days||95% Confidence Interval|Median
1346163|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05.|||days||Full Range|Median
1346164|NCT01853384|Primary|Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|"For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed.~For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed."|Weekly, over 12 Weeks or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article.|||participants|||Number
1346165|NCT01853371|Primary|Diastolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
1346166|NCT01853371|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.~Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month|||||||
1346167|NCT01853371|Primary|Systolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
1346183|NCT01853215|Primary|Occurrences of Extravasation During Infusion|The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.|during 12 minutes of infusion|Per protocol|||participants|||Number
1346168|NCT01853332|Secondary|Health Risk Factors|An index score of health behavior risk factors was created. Any amount of smoking, non-optimal drinking (≥ 7 drinks per week for women; ≥ 14 drinks per week for men), a score in the bottom tertile of the AHEI, and minimal exercise (< 6 metabolic hours per week) were considered risk factors, coded as “1”, and then tallied. The range of scores for health risk factors in the current sample was between 0 and 4 health risk factors (where 4 is more risk factors).|cross-sectional||||sum of health risk factors||Standard Deviation|Mean
1346169|NCT01853332|Secondary|Body Mass Index (BMI)|BMI is calculated as weight in kilograms divided by height in meters squared.|cross-sectional||||kg/m^2||Standard Deviation|Mean
1346170|NCT01853332|Primary|Social Adjustment Scale|The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months in domains of work (including employment functioning, homemaking and other household functions, and/or student/educational functioning), friendships/leisure, and relationships with extended family. If applicable, relationships with immediate family members (spouse/partner and/or children) are also assessed. The SAS is closely linked to mental health and can be used as a tool for assessing treatment response to psychotropic medications or therapies. Positive adjustment is the ability to carry out each activity/role effectively, deriving satisfaction/support from that domain, whereas poor adjustment reflects maladaptation, dissatisfaction, disengagement, and/or discord. Scores range from 1 (excellent adjustment) to 7 (very poor adjustment). Coding was completed during an audio-recorded interview; 12% were coded for agreement (91%).|2.5 years||||units on a scale||Standard Deviation|Mean
1346171|NCT01853332|Primary|Psychosocial Health Risk Factors Correlated With BMI|Correlations of scales with BMI score. Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0–13; higher is more adversity). An overall adversity score was created by multiplying the number of childhood adversities × the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 to 156 (higher is more adversity). The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent adjustment) to 7 (very poor adjustment). Psychosocial risk factors is an index of 1 to 3 (higher is more risk). Health risk score adds smoking, non-optimal drinking (>7/14 drinks/week for women/men), a score in the bottom tertile of the AHEI, and minimal exercise (<6 hours/week)and tallied (scores0-4 with higher worse).|2.5 years||||Pearson Correlation Coefficients|||Number
1346172|NCT01853332|Primary|Psychosocial Adversity|Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0–13, higher more).An overall adversity score was created by multiplying the number of childhood adversities×the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 (no) to 156 more adversity).The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent) to 7 (very poor adjustment). An index score of psychosocial risk factors was created. Education less than a Bachelor's degree, unemployment, and a social adjustment scale score indicative of non-optimal functiong (≥ 3) were considered risk factors, coded as “1”, and then tallied. Range of scores 0 (less)-3 (more risk).|2.5 years||||units on a scale||Standard Deviation|Mean
1346173|NCT01853332|Primary|Hormonal Levels|"To assess clinically significant physical health outcomes including 1) establishing risk factors for CVD and type 2 diabetes mellitus (DM) 2) establishing novel risk factors for CVD and DM (e.g., inflammatory markers, hormonal mediators ), and 3) determining the prevalence of established CVD and DM.~Both insulin and glucose will be measured.~Adipokines.~Myokines.~Triglycerides and HDL cholesterol will be considered in light of their relevance to CVD.~Proinflammatory markers."|2.5 years||||ng/ml||Inter-Quartile Range|Mean
1346174|NCT01853280|Primary|Adult ADHD Investigator Symptom Rating Scale (AISRS)|The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54. The AISRS was compared from baseline to completion, over the course of the 12 week study.|12 weeks|While 44 subjects were randomized to receive the study drug, only 41 subjects actually began taking the medication, and as such were evaluated using the AISRS.|||units on a scale||Standard Deviation|Mean
1346175|NCT01853254|Primary|Percentage of Participants With at Least 1 Adverse Event||From Baseline to the end of the study (up to 72 weeks)|All participants analysis set.|||Percentage of participants|||Number
1346176|NCT01853215|Secondary|300mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
1346177|NCT01853215|Secondary|200mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
1346178|NCT01853215|Secondary|100mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
1346179|NCT01853215|Secondary|Gravity Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
1346180|NCT01853215|Secondary|Adhesion Strips|Perceived effeciveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; $=Very good; 5=Excellent.|During insertion of the intraosseous needle set||||Likert scale||Standard Deviation|Mean
1346181|NCT01853215|Secondary|Stability of Catheter Hub|Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy.|During insertion of the intraosseous needle set||||Likert scale||Standard Deviation|Mean
1348308|NCT01824446|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Up to 288 hours post-dose|PAS|||hours||Full Range|Median
1346186|NCT01853085|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure|||Patients|||Number
1346187|NCT01853085|Secondary|Number of Patients Who Continue Treatment|Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.|12 Weeks|All enrolled patients|||Patients|||Number
1346188|NCT01853085|Secondary|Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment|Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.|12 Weeks|All enrolled patients|||Patients|||Number
1346189|NCT01853085|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure|||Patients|||Number
1346190|NCT01853085|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure|||Patients|||Number
1346191|NCT01853085|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.|Baseline, 12 Weeks|All patients with data for this outcome measure|||Patients|||Number
1346192|NCT01853085|Primary|Intraocular Pressure (IOP) in the Study Eye at Baseline|IOP is a measurement of the fluid pressure inside the study eye.|Baseline|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1346193|NCT01853072|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
1346194|NCT01853072|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
1346195|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set|||Percentage of participants|||Number
1346196|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set|||Percentage of participants|||Number
1346197|NCT01853072|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set|||Percentage of participants|||Number
1346198|NCT01853072|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set|||Percentage of participants|||Number
1346199|NCT01853046|Other Pre-specified|Tumor Response Assessment for Measurable Lesions According to RECIST, v1.1 (Response Evaluation Criteria in Solid Tumors)|"Positron emission tomography - computed tomography (ET-CT), CT, or magnetic resonance imaging (MRI) scans of all anatomic regions involved with the disease were performed to assess tumor response using the Response Evaluation Criteria in Solid Tumors, Version 1.1. (RECIST v1.1). Bone metastases were assessed by bone scintigraphy (bone scan). Tumor measurements and evaluation of tumor response were performed at baseline and within the last 7 days of Cycle 2. Thereafter, if subjects continued regorafenib treatment, tumor assessments were performed after every third cycle and at the end-of-treatment (EOT) visit. In addition, outcome of Assessment of Bone Metastases by Scintigraphy if Applicable (Bone Scan) was registered, the results of which has been reported as tumor response in this outcome as well."|Up to 6 months|Participants in the Normal/mild renal impairment group had only tumor assessments at screening, thus excluded from efficacy analysis.|||participants|||Number
1346200|NCT01853046|Secondary|AE,ur(10-24) Stage 2 for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 10-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
1346201|NCT01853046|Secondary|AE,ur(0-10) Stage 2 for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 0-10 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
1346202|NCT01853046|Secondary|AE,ur(10-24) Stage 1 ((Amount of Drug Excreted Via Urine During the Collection Interval 10–24 Hours Post Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 1-2: 10-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
1346203|NCT01853046|Secondary|AE,ur(0-10) Stage 1 (Amount of Drug Excreted Via Urine During the Collection Interval 0–10 Hours Post Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 1-2: 0-10 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
1346204|NCT01853046|Secondary|AE,ur(0-24)md (AE,ur(0-24) After Multiple-dose Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 0-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
1346874|NCT01843348|Secondary|Percent of Participants With Delayed Graft Function by Day|Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.|Post transplant up to day 7|Full analysis set|||Percent of participants|||Number
1346205|NCT01853046|Secondary|RLin (Linearity Factor Calculated as Ratio From AUC(0-24)md and AUC) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. RLin is the linearity factor of PK after multiple administrations of identical doses calculated as ratio of AUC(0-24)md and AUC.|Up to 25 days|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||Linearity factor calculated as ratio||Geometric Coefficient of Variation|Geometric Mean
1346206|NCT01853046|Secondary|RAAUC (Accumulation Ratio Calculated From AUC(0-24)md and AUC(0-24)) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. RAAUC calculated as ratio of AUC(0-24)md and AUC(0-24).|Up to 25 days|In Normal/mild renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=13, 13 and 12 respectively. In Severe renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=4, 4 and 3 respectively. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||Accumulation Ratio||Geometric Coefficient of Variation|Geometric Mean
1346207|NCT01853046|Secondary|RACmax (Accumulation Ratio Calculated From Cmax,md and Cmax) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as ratio of Cmax,md and Cmax.|Up to 25 days|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||Accumulation Ratio||Geometric Coefficient of Variation|Geometric Mean
1346208|NCT01853046|Secondary|Tlast,md (Tlast After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||h||Full Range|Median
1346209|NCT01853046|Secondary|Tmax,md (Time to Reach Maximum Drug Concentration in Plasma After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||h||Full Range|Median
1346210|NCT01853046|Secondary|AUC(0-tlast)md (AUC(0-tlast) After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1346211|NCT01853046|Secondary|Cmax,md (Cmax After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1346212|NCT01853046|Secondary|AUC(0-24)md ((AUC(0-24) After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose|In Normal/mild renal impairment group, number of participants analyzed is 13. In Severe renal impairment group, number of participants analyzed is 4. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1346213|NCT01853046|Secondary|Vz/F (Apparent Volume of Distribution During Terminal Phase After Single (First) Oral Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||L||Geometric Coefficient of Variation|Geometric Mean
1346214|NCT01853046|Secondary|CL/F (Total Body Clearance of Drug After Extravascular Administration) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||L/H||Geometric Coefficient of Variation|Geometric Mean
1346215|NCT01853046|Secondary|t1/2 (Half-life Associated With the Terminal Slope) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in hours (h) and derived from the terminal slope of the concentration versus time curve.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||h||Geometric Coefficient of Variation|Geometric Mean
1346216|NCT01853046|Secondary|Tlast (Time of Last Data Point >LLOQ) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||h||Full Range|Median
1346217|NCT01853046|Secondary|Tmax (Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||h||Full Range|Median
1346218|NCT01853046|Secondary|Cmax (Maximum Drug Concentration in Plasma After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||mg/L||Geometric Coefficient of Variation|Geometric Mean
1346219|NCT01853046|Secondary|AUC(0-24) (AUC From Time Zero to 24 Hours p.a. After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC(0-24) is defined as AUC divided from zero to 24 hours after single (first) dose.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose|In Normal/mild renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=18, 18, and 17 respectively. In Severe renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=6, 6, and 5 respectively. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1346220|NCT01853046|Secondary|AUC (Area Under the Plasma Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1346221|NCT01853046|Primary|AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0–24 Hours Post Administration) for Metabolites M-7 and M-8|Amount of drug excreted into urine during the collection interval 0-24 hours post dose was expressed as percentage of administered dose.|Days 1-2: 0-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
1346222|NCT01853046|Primary|AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. The AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1346223|NCT01852955|Secondary|Postoperative Pain in the Post Anesthesia Care Unit|Postoperative pain within the post anesthesia care unit after surgery. Area under the numeric rating scale for pain versus time curve in the post anesthesia care unit (score * min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). Area under a curve units of the horizontal axis multiplied by the units of the vertical axis. A higher value indicates more pain and time in the Post Anesthesia Care Unit.The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|Time in the post anesthesia care unit after surgery (average of 5 hours)||||(units on a scale * minutes||Inter-Quartile Range|Median
1346224|NCT01852955|Secondary|Postoperative Opioid Consumption|Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents.|24 hour||||oral mg of morpine equivalents||Inter-Quartile Range|Median
1346225|NCT01852955|Primary|Quality of Recovery at 24 Hours(QoR-40 Instrument)|Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).|24 hours after the surgical procedure||||units on a scale||Inter-Quartile Range|Median
1346226|NCT01852825|Secondary|Change From Baseline in Time Weighted Average (TWA) Over 1 Hour Pre-NAC Through 1 Hour Post-NAC Visual Analog Score (VAS) for Sneezing, Rhinorrhea, Congestion and Nasal Itch Following 12 Weeks of Treatment (Part 2)|A visual analog scale (VAS) representing the spectrum of symptoms from absent (0) to extremely severe (100) for each of rhinorrhea, nasal blockage, sneezing and nasal itch were summed to obtain an overall score. The range of VAS overall score is 0 - 400, with higher numbers representing worse symptoms. The models for the time-weighted mean (TWA) of the summed scores over 1 hour pre-NAC through hour 1 following NAC were constructed at the original scale.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1346227|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Nasal Epithelial Eosinophil-related Messenger RNA (mRNA) Signature Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of nasal epithelial eosinophil-related mRNA signature 6.5 hours after NAC in serum at baseline and at week 12 were measured. The mRNA signature is derived from nine gene transcripts which were measured using the NanoString nCounter Gene Expression Assay. Positive control and pre-specified housekeeping gene normalization methods recommended by nSolver were used to normalize the transcripts. The average of the expression level of the nine genes was used to describe the eosinophil mRNA signature. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold change||95% Confidence Interval|Least Squares Mean
1347147|NCT01838863|Other Pre-specified|Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock|Number of blood products transfused in units in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||units||Inter-Quartile Range|Median
1346228|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Interleukin-5 (IL-5) Protein Concentration in Nasal Exudates Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of Il-5 protein 6.5 hours after NAC in serum at baseline and at week 12 were measured. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. IL-5 protein concentration was measured in nasal exudates collected both pre- and post-nasal challenge. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold change||95% Confidence Interval|Least Squares Mean
1346229|NCT01852825|Primary|Change From Baseline in HDM-specific IgE Blocking Factor (IgE-BF) in Serum at 12 Weeks|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the amount of IgE-BF in serum was measured based on an Ordinary IgE measurement and an assay in the presence of Competitors; with IgE-BF = 1 - (Competitive IgE/Ordinary IgE). This ranges from 0 (no IgE blocked) to 1 (all IgE blocked); and as it is based on a ratio there are no units. Change from baseline (12 weeks minus baseline) was evaluated based on cLDA method, and was analyzed based on the original scale. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the 1-tailed 95% CI around the 12 week mean difference in change from baseline in HDM-specific IgE blocking factor response excludes zero.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Ratio||95% Confidence Interval|Least Squares Mean
1346230|NCT01852825|Primary|Change From Baseline in D. Pteronyssinus HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with D. pteronyssinus HDM, and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on cLDA method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold Change||95% Confidence Interval|Geometric Mean
1346231|NCT01852825|Primary|Change From Baseline in D. Farinae HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with Dermatophagoides (D.) farinae HDM and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on constrained longitudinal data analysis (cLDA) method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold Change||95% Confidence Interval|Geometric Mean
1346232|NCT01852812|Primary|Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||Hours||Standard Deviation|Mean
1346233|NCT01852812|Primary|Time to Cmax (Tmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||Hours||Standard Deviation|Mean
1346234|NCT01852812|Primary|Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||ng/mL||Standard Deviation|Mean
1346235|NCT01852812|Primary|Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG|Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The All Subjects Pharmacokinetically Evaluable (ASPE) population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||h*ng/mL||Standard Deviation|Mean
1346540|NCT01847547|Secondary|Incidence Rate of Hemorrhagic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346236|NCT01852812|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received.|Up to 12 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.|||Percentage of participants|||Number
1346237|NCT01852812|Primary|Percentage of Participants Who Experience at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received.|Up to 14 days after last dose of study drug (Up to 14 weeks)|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.|||Percentage of participants|||Number
1346238|NCT01852799|Other Pre-specified|Evaluation of Responses(PFS)|Efficacy parameters PFS will be evaluated by normal methodology. PFS =（date of signing informed consent form minus the date of first documented progression or date of death from any cause plus 1）/30.5（months）|From date of signing informed consent form until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||months||95% Confidence Interval|Median
1346239|NCT01852799|Other Pre-specified|Safety Evaluation|Safety evaluations will be based on scheduled physical examinations, Eastern Cooperative Oncology Group(ECOG) scores, vital signs (blood pressure, heart rate) and clinical laboratory tests.|Starting with informed consent signature through study completion, an average of 1 year||||Participants|||Count of Participants
1346240|NCT01852799|Other Pre-specified|Evaluation of Responses|Evaluation of responses was performed every cycle. Responses were assessed according to the european group for blood and marrow transplantation（EBMT） criteria (An attempt will be made to collect data for the assessment of stringent complete response (sCR) if these data are available.). Other efficacy parameters including PFS and 1-year overall survival rate and overall survival will be evaluated by normal methodology. According to EBMT criteria, responses were assessed by changes in the level of the serum paraprotein and/or urinary light chain excretion.The specific assessment rules may refer to EBMT criteria for MM.|At baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up||||Participants|||Count of Participants
1346241|NCT01852799|Secondary|Skeletal Related Events' Evaluation|Skeletal survey of the skeleton using plain radiography will be performed at baseline, on day 28 of cycle 4, and after 6, 12 and 18 months of follow-up or until start of alternative MM treatment, if earlier. SREs, such as pathological fractures, need for radiation therapy or surgery will be recorded at the time of the event.|At baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment|Data were not collected.||||||
1346242|NCT01852799|Secondary|Measurement of Bone Mineral Density|The effect on bone mineral density（BMD） will be measured by quantitative analysis of qCT scans of the intra-individual same region [lumbar spine and hip] at baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment, if earlier.|At baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment|Data were not collected.||||||
1346243|NCT01852799|Primary|Bone Formation Markers Measurement|The bone formation marker- bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）are measured on serum samples by ELISA methodology at baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative multiple myeloma(MM) treatment, if earlier.|Up to Cycle 4 with 28 days per cycle||||U/L||Standard Deviation|Mean
1346244|NCT01852669|Primary|Number of Participants Who Are Stone Free at 3 Months|To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)|3 months||||participants|||Number
1346245|NCT01852591|Secondary|CD8+CD107a+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.|||percentage of CD8 cells|||Number
1346246|NCT01852591|Secondary|CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30.|30 Days Post Vaccine|All evaluable participants.|||percentage of CD8 cells|||Number
1346247|NCT01852591|Secondary|CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.|||percentage of CD4 cells|||Number
1346248|NCT01852591|Primary|Number of Participants With Immune Response|Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.|30 Days Post Vaccine|All evaluable participants.|||participants|||Number
1346249|NCT01852383|Other Pre-specified|Maximum Duloxetine Oral Dose|Maximum duloxetine oral dose|Week 0, 1, 2, 4, 6, 8, 10, 12||||mg||Standard Deviation|Mean
1350554|NCT01790178|Primary|Amount of Tissue Obtained|This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).|At time of biopsy||||grams||Standard Deviation|Mean
1346250|NCT01852383|Secondary|Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12|Cornell Dysthymia Rating Scale scores from range 0-64. Lower or decreasing scores represent decreased severity and a better outcome, while higher or increasing scores represent more severe depression and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Week 0 and 12||||units on a scale||Standard Deviation|Mean
1346251|NCT01852383|Other Pre-specified|Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.|The Treatment Emergent Symptom Scale (TESS) documents the presence of common side effects. There are 26 items and the total score range is 0-26. Low scores or decrease in scores represent less side effects and high scores or increase in scores represent more side effects. The change in side effect severity scores was calculated by subtracting the Week 12 score from the Week 0 score.|0 and 12 weeks||||units on a scale||Standard Deviation|Mean
1346252|NCT01852383|Primary|Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks.|The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit. Hamilton Rating Scale for Depression scores range from 0-50 with low scores or decreasing scores representing decreased severity and better outcome, and higher scores or increasing scores representing more severe depressive symptoms and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Screen (0) and 12 weeks||||units on a scale||Standard Deviation|Mean
1346253|NCT01852344|Secondary|Reaction Time Variability on the Multi-Source Interference Task.|Reaction time variability on the Multi-Source Interference task is defined as the number of milliseconds between an individual's lowest and highest reaction time. This is averaged across all participants.|20-30 minutes|Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.|||milliseconds||Standard Deviation|Mean
1346254|NCT01852344|Secondary|Accuracy on the Multi-Source Interference Task.|Patients completed 200 trials and the percentage of answers correct was calculated.|20-30 minutes|Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.|||percentage of answers which were correct||Standard Deviation|Mean
1346255|NCT01852344|Primary|Reaction Time on the Multi-Source Interference Task|Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated.|20-30 minutes for task completion|Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.|||milliseconds||Standard Deviation|Mean
1346256|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for CL/F|To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for CL/F.|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||L/hr||Full Range|Median
1346257|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Tmax|To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Tmax.|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||hour (hr)||Full Range|Median
1346258|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Cmax|To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Cmax.|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||ng/mL||Full Range|Median
1346259|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for AUC0-24 and AUClast|To Characterize PK of buparlisib given in combination with paclitaxel for AUC0-24 (area under plasma concentration-time curve from time 0 to end of dosing interval of 24 hours) & AUClast (AUC from time 0 to last measurable concentration sampling time).|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||ng*hr/mL||Full Range|Median
1346260|NCT01852292|Secondary|Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35|A summary of EORTC-QLQ-HN35 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as an increase in the subscale score of at least 10% compared to baseline, with no later decrease above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.|Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||Months||95% Confidence Interval|Median
1346328|NCT01851330|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study medication.|||percentage of participants|||Number
1346261|NCT01852292|Secondary|Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30|A summary of EORTC-QLQ-C30 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as a decrease in the subscale score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.|Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||95% Confidence Interval|Median
1346262|NCT01852292|Secondary|Duration of Response (DoR) as Per Local Investigator|DoR is the time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease according to RECIST v1.1 .|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||Full Range|Median
1346263|NCT01852292|Secondary|Disease Control Rate (DCR) as Per Local Radiological Assessment|DCR is the percentage of patients with a best overall response of CR, PR or stable disease (SD), according to RECIST v1.1. CR is defined as disappearance of all target lesions & any pathological lymph nodes must have a short axis of <10 mm & the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm). SD is defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2.|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||Percentage of participants||95% Confidence Interval|Number
1346264|NCT01852292|Secondary|Time to Response (TTR) as Per Local Radiological Assessment|TTR is the time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||Full Range|Median
1346265|NCT01852292|Secondary|Overall Response Rate (ORR) as Per Local Radiological Assessment|ORR: percentage of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||Percentage of participants||95% Confidence Interval|Median
1346266|NCT01852292|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||95% Confidence Interval|Median
1346267|NCT01852292|Primary|Progression Free Survival (PFS) Per Investigator Assessment|PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression per RECIST v. 1.1 or death due to any cause. If a patient has not progressed or died at the analysis cut-off date or when the patient receives further anti-neoplastic therapy, PFS was censored on the date of the last adequate tumor assessment before the earlier of the cut-off date or start of the further anti-neoplastic therapy date.|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||95% Confidence Interval|Median
1346268|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|2 hours||||PRI||95% Confidence Interval|Least Squares Mean
1346269|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|1 week||||PRI||95% Confidence Interval|Least Squares Mean
1346270|NCT01852214|Secondary|P2Y12 Reaction Units|Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel)|2 hours||||PRU||95% Confidence Interval|Least Squares Mean
1346329|NCT01851174|Secondary|Progression Free Survival Time|Determine progression free survival time with this regimen|One year|The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left. Data were not collected||||||
1348831|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Tetanus|Summary of trough antibody concentrations prior to specified infusion for Tetanus|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||IU/mL||Standard Error|Mean
1346271|NCT01852214|Primary|P2Y12 Reaction Units|The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence.|1 week|All analyses of platelet function conducted on all randomized subjects who received study drug, successfully completed at least one treatment period of the study and had valid data for the primary end point.|||PRU||95% Confidence Interval|Least Squares Mean
1346272|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.|24 hours||||PRI%||Standard Error|Least Squares Mean
1346273|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.|2 hours||||PRI%||Standard Error|Least Squares Mean
1346274|NCT01852175|Primary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.|1 week||||PRI%||Standard Error|Least Squares Mean
1346275|NCT01852162|Secondary|Clot Kinetic: Clot Stength|Clot strength (maximal amplitude:MA) was assessed by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography|||mm||Standard Deviation|Mean
1346276|NCT01852162|Secondary|Clot Kinetic: Thrombin Activity|Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography|||minutes||Standard Deviation|Mean
1346277|NCT01852162|Secondary|Platelet Reactivity Measured by Multiple Electrode Aggregometry.|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry.|1-week|Platelet aggregation measured by multiple electrode aggregometry.|||arbitrary aggregation units||Standard Deviation|Mean
1346278|NCT01852162|Secondary|Platelet Reactivity Measured by LTA|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA).|1-week|Platelet aggregation measured by LTA|||percentage of aggregation||Standard Deviation|Mean
1346279|NCT01852162|Primary|TRAP-induced Platelet Aggregation|TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups|1 week|TRAP-induced platelet aggregation|||percentage of aggregation||Standard Deviation|Mean
1346280|NCT01852110|Secondary|Change From Baseline in CCS-3D at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)|CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.|Baseline and Week 12|Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 – 15 mg, or MK-7622 – 45 mg, having either a baseline or 12-week CCS-3D assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure.||||||
1346281|NCT01852110|Secondary|Change From Baseline in Composite Cognition Score-3 Domain (CCS-3D) at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)|CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.|Baseline and week 12|All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week CCS-3D assessment.|||z-score||Standard Error|Mean
1346282|NCT01852110|Secondary|Change From Baseline in Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) at Week 24 (Combining Stage 1 and 2, MK-7622 45 mg Versus Placebo)|Mean change from baseline at week 24 was assessed for ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with potential total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.|Baseline and week 24|Per protocol, analysis population was to include all randomized participants (pooled across Stages 1 and 2) receiving ≥1 dose of placebo or MK-7622 – 45 mg, having either a baseline or 24-week ADCS-ADL assessment. As the study was terminated before Stage 2 enrollment, only participants in Stage 1 were analyzed.|||Score on a Scale||Standard Error|Mean
1346283|NCT01852110|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|The number of participants discontinuing study drug due to an AE was assessed.|Up to 24 weeks|All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms.|||Participants|||Count of Participants
1346686|NCT01845636|Secondary|Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-plus)|The CIBIC-plus is a well-validated, reliable and widely used measure (range 1-7) of global improvement used in AD and MCI trials. This is a measure of change based on clinician impression.|Week 8, Week 26, Week 52||||units on a scale||Standard Deviation|Mean
1346284|NCT01852110|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Up to 26 weeks|All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms.|||Participants|||Count of Participants
1346285|NCT01852110|Primary|Change From Baseline in ADAS-Cog11 Score at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)|Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer’s Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score.|Baseline and week 12|Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 – 15 mg, or MK-7622 – 45 mg, having either a baseline or 12-week ADAS-Cog11 assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure.||||||
1346286|NCT01852110|Primary|Change From Baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)|Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer’s Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score.|Baseline and week 12|All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week ADAS-Cog11 assessment.|||Score on a Scale||Standard Error|Mean
1346287|NCT01852032|Primary|Beta of Tomosynthesis Medial Lateral Oblique View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
1346288|NCT01852032|Primary|Beta of Tomosynthesis Craniocaudal View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
1346289|NCT01852032|Primary|Beta of CT Axial View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
1346290|NCT01852032|Primary|Beta of CT Sagittal View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
1346291|NCT01852032|Primary|Beta of CT Coronal View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
1346292|NCT01852019|Secondary|Bleeding Events in Accordance With the GUSTO Scale|Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993].|Day 1 through Day 8||||participants|||Number
1346293|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||platelet reaction units (PRU)||Standard Deviation|Mean
1346294|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||platelet reaction units (PRU)||Standard Deviation|Mean
1346295|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
1346296|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
1346297|NCT01851876|Primary|Clinical Pregnancy Rate||4 months||||participants|||Number
1346298|NCT01851876|Primary|Clinical Pregnancy Rate||up to 6 months|||||||
1346299|NCT01851863|Other Pre-specified|Number of Participants With Adverse Reaction|Number of participants with adverse reactions were recorded to analyze the safety profile of treatment.|8 weeks||||participants|||Number
1346300|NCT01851863|Secondary|Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8|Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome.|week 0 and 8||||units on HADS score||Full Range|Mean
1346301|NCT01851863|Secondary|Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8|The severity of patients’ dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and > 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome.|week 0 and 8||||units on LDQ scale||Full Range|Mean
1346302|NCT01851863|Primary|Compliance of Flupentixol-Melitracen|The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.|weeks 1, 2, 4, 8||||participants|||Number
1346303|NCT01851772|Other Pre-specified|Frequency of Adverse Events in Participants (i.e.Safety)|To assess occurrence rate of radiation toxicities through three (3) months of follow-up.|3 months post-Study Exit||||participants|||Number
1346304|NCT01851772|Secondary|Device Performance|Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.|Study Exit (90 days)||||participants|||Number
1346305|NCT01851772|Primary|Safety|Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.|Study Exit (90 days)|Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA).|||percentage of participants and severity|||Number
1346306|NCT01851720|Primary|Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).|Pain score 0-10. 0 represented no pain and 10 worst pain|4 days|Though one subject in the PCA arm completed enrollment, we had insufficient data to perform any comparative analysis. We do no intend to summarize the patient's results.||||||
1346307|NCT01851655|Other Pre-specified|Change in Anterior Knee Laxity|Anterior knee laxity will be assessed with a knee arthrometer and a maximum manual pull. The side-to-side difference will be recorded in mm. The change will be computed as (post-intervention difference minus pre-intervention difference).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||mm||Standard Deviation|Mean
1346308|NCT01851655|Other Pre-specified|Change in Fear of Movement/Re-injury|The 11-item version of the Tampa Scale for Kinesiophobia will be used to assess kinesiophobia or fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores equal higher fear of movement/re-injury. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
1346309|NCT01851655|Other Pre-specified|Change in Quadriceps Strength|Knee extensor torque will be measured with an isokinetic dynamometer. The lever arm will move at 60 degrees/second. The peak torque from 5 trials will be obtained and normalized to body weight. The change will be computed as (post-intervention value minus pre-intervention value)|Baseline (pre-intervention) to 9 weeks (post-intervention)||||ft-lb/lb||Standard Deviation|Mean
1346541|NCT01847547|Secondary|Incidence Rate of Ischemic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346310|NCT01851655|Secondary|Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.|CTX-II is a biomarker of Type II articular cartilage degradation. Type II collagen carboxy propeptide (CPII) is a biomarker of Type II collagen synthesis. Early morning urine and blood samples will be collected pre- and post-treatment. Urinary CTX-II will be analyzed as described in Primary Outcomes. Serum CPII will be determined using enzyme-linked immunosorbent assay. Values of both biomarkers will be log-transformed, and the ratio of CTXII:CPII will be calculated. The change will be computed as (post-intervention CTXII:CPII values minus pre-intervention CTXII:CPII value).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||log [(ng/mmol)/(ng/mL)]||Standard Deviation|Mean
1346311|NCT01851655|Secondary|Change in Vertical Jump Height.|Vertical jump height will be assessed with the Vertex. The average of three trials will be recorded in cm. The change in vertical jump height will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||cm||Standard Deviation|Mean
1346312|NCT01851655|Primary|Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||log-scale transformed value of ng/mmol||Standard Deviation|Mean
1346313|NCT01851655|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Form Score.|The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
1346314|NCT01851590|Secondary|Compliance to the Treatment|Evaluation of compliance was based on patient self-reports of whether the treatment protocol was followed 100% (complete), 80% (good), 60% (moderate), or 40% (poor) of the time.|At 4-month time-point|Percentage describes the proportion of patients who declared that they have been followed the instructions completely (100%).|||percentage of participants|||Number
1346315|NCT01851590|Secondary|Cost-effectiveness 2|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) during the treatment period per patient in each group.|At 10-month time-point||||Euros (€)||95% Confidence Interval|Mean
1346316|NCT01851590|Secondary|Cost-effectiveness 1|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) per day per patient in each group.|At 10-month time-point||||Euros (€)||95% Confidence Interval|Mean
1346317|NCT01851590|Secondary|Clinical Responses to the Treatments|Clinical responses to treatment were based on the proximal linear growth of healthy nail; thus, the clinical responses were classified as partial (evident proximal linear growth of healthy nail) or complete. Partial responses were defined as significant reductions in onycholysis, subungual hyperkeratosis, and streaks. A complete response was a fully normal appearance of the toenail.|At 4- and 10 months time-points from the beginning of the study.|Intention-to-treat population, last observation carried forward.|||percentage of participants|||Number
1346318|NCT01851590|Primary|Mycological Cure|To analyze the rate of complete mycological cure i.e. fungal eradication in terms of negative mycological culture AND negative potassium hydroxide (KOH) stain at 4- and 10 months time-points from the beginning of the study.|At 4- and 10 months time-points from the beginning of the study.|Primary and secondary outcome analyses were based on the intent-to-treat (ITT) population and missing values were imputed using the last observation carried forward (LOCF) method.|||Percentage of participants||95% Confidence Interval|Number
1346319|NCT01851330|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-Treatment Virologic Failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1346320|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with Available Data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1346321|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with Available Data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1346322|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with Available Data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1346323|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with Available Data were analyzed.|||percentage of participants|||Number
1346324|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with Available Data were analyzed.|||percentage of participants|||Number
1346325|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with Available Data were analyzed.|||percentage of participants|||Number
1346330|NCT01851174|Primary|Overall Survival Based on Toxicity Profile of Adverse Events.|Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel|One year|The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left.||||||
1346331|NCT01850745|Secondary|Efficacy of Treatment Measured by Sustained Virological Response|"The secondary efficacy end point was to evaluate the sustained virological response (SVR) of antiviral treatment.~SVR was defined as undetectable hepatitis C virus viral load (<15 IU/ml) 24 weeks after treatment completion.~Non-SVR was defined as detectable hepatitis C virus viral load (>15 IU/ml) 24 weeks after treatment completion."|baseline and 72 weeks|||||||
1346332|NCT01850745|Primary|Adherence to Treatment|"Adherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks).~Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks)."|48 months||||participants|||Number
1346333|NCT01850615|Secondary|Number of Adverse Events|All adverse events (AEs) described here refer to treatment emergent adverse events (TEAE). A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment, week 18.|Weeks 0-18|The SAS included all subjects receiving at least one dose of the investigational product or its comparator.|||Number of events|||Number
1346334|NCT01850615|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|Plasma glucose (PG) was measured and recorded when a hypoglycaemic episode was suspected. All PG values ≤3.9 mmol/L (70 mg/dL) or >3.9 mmol/L (70 mg/dL) when they occurred in conjunction with hypoglycaemic symptoms were recorded by the subject. Numbers of treatment emergent hypoglycaemic episodes were recorded during 18 weeks of treatment.|Weeks 0-18|The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.|||Number of episodes|||Number
1346335|NCT01850615|Secondary|Change From Baseline in Body Weight|For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the “end of trial” data containing last available measurements.|Week 0, week 18|FAS included all randomised subjects.|||Kg||Standard Deviation|Mean
1346336|NCT01850615|Secondary|Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)|"For this endpoint the end of trial data containing last available measurements are presented. Prandial PG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point profiles (SMPG) as the difference between the PPG value 2 hours after each meal and the PG value before each meal. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements."|After 18 weeks of randomised treatment|FAS included all randomised subjects. Number analysed for individual time-points = treatment wise number of subjects who contributed to analysis.|||mmol/L||Standard Deviation|Mean
1346337|NCT01850615|Secondary|Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)|"For this endpoint the end of trial data containing last available measurements are presented. PPG measurements were recorded by the subjects at 2 hours after each meal (breakfast, lunch and main evening meal) as part of three 7-point profiles (SMPG) prior to the visits. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements."|After 18 weeks of randomised treatment|FAS included all randomised subjects. Number analysed for individual time-points = treatment wise number of subjects who contributed to analysis.|||mmol/L||Standard Deviation|Mean
1346338|NCT01850615|Primary|Change From Baseline in HbA1c|For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the “end of trial” data containing last available measurements.|Week 0, week 18|Full analysis set included all randomised subjects.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1346339|NCT01850589|Primary|Number of Participants With Smoking Cessation at 12 Months|Conservative vs. aggressive smoking strategies in treating smoking cessation.|12 months|Mean follow up was 7.3 months|||Participants|||Number
1346340|NCT01850550|Secondary|Dietary Intake|Assessed using the NCI Dietary History Questionnaire|12 weeks after initial consent|||||||
1346341|NCT01850550|Secondary|Physical Activity|Assessed by the International Physical Activity Questionnaire|12 weeks after initial consent|||||||
1346342|NCT01850550|Secondary|Blood Pressure|Blood pressure will be recorded using an OMRON automatic blood pressure cuff.|12 weeks after initial consent|||||||
1346343|NCT01850550|Secondary|BMI|Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.|12 weeks after initial consent||||kg/m^2||Full Range|Mean
1346344|NCT01850550|Primary|Percent Change in Weight|We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.|12 weeks after initial consent||||percent weight change||Full Range|Mean
1346345|NCT01850485|Secondary|SvO2|(venous oxygen saturation)|24 hours||||percent saturation||Standard Deviation|Mean
1346346|NCT01850485|Secondary|Lactate|lactate levels in serum|24 hours||||mmol/l||Standard Deviation|Mean
1346347|NCT01850485|Secondary|Cardiac Index|Cardiac Index is cardiac output indexed for body weight|24 hours||||L/m2||Standard Deviation|Mean
1346348|NCT01850485|Secondary|Inotropes and Vasopressor Dose||baseline||||mcg/kg/min||Inter-Quartile Range|Median
1346349|NCT01850485|Secondary|Fluid Balance After 24 Hours||24 hours||||liters||Standard Deviation|Mean
1346350|NCT01850485|Secondary|RincStO2|tissue oxygenation measured by Near Infrared Spectroscopy|baseline||||percent saturation||Standard Deviation|Mean
1346351|NCT01850485|Primary|Microvascular Flow Index (MFI)|Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)|baseline measurement||||units on a scale||Inter-Quartile Range|Median
1346352|NCT01850394|Primary|Total Hemoglobin Loss|Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day|5 days after surgery|Use intention-to-treat analysis|||g/dL||Standard Deviation|Mean
1346353|NCT01850394|Secondary|Number of Patients Having Postoperative Complications|"Postoperative complications were measured as an incidence of the following complications;~wound hematoma~surgical site infection~systemic infection~deep vein thrombosis~pulmonary embolism~knee stiffness requiring manipulation~medical complication such as myocardial infarction, congestive hear failure"|postoperative 1-year period|Using Intention-to-treat analysis|||participants|||Number
1346354|NCT01850394|Secondary|Number of Patients Required Blood Transfusion||postoperative period (5 days after surgery)||||participants|||Number
1346355|NCT01850394|Secondary|Knee Function Scores|"Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.~Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.~1.2. Function score : calculated from patient’s ability to walk and climb stairs. The score ranges from 0-100, more score means better.~Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better."|1 year after surgery|Using intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
1346356|NCT01850394|Primary|Perioperative Blood Loss|"Drainage blood loss measured by accumulating total drainage volume postoperatively~Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day"|5 days after surgery|Using intention-to-treat analysis|||ml||Standard Deviation|Median
1346357|NCT01850030|Secondary|Gender of the Newborn|was recorded and collected for Newborn|After delivery (about 9 months after IVF)||||number of newborns|||Number
1346358|NCT01850030|Secondary|Percentage of Participants With a Successful Completion of Pregnancy|Incidence of live births and healthy newborns|After delivery (about 9 months after IVF)||||percentage of participants||95% Confidence Interval|Number
1346359|NCT01850030|Secondary|Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer|Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer|Day 14 after embryo transfer||||percentage of participants||95% Confidence Interval|Number
1346360|NCT01850030|Primary|Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound|Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound|12 weeks´ gestation (at visit 6)||||percentage of participants||95% Confidence Interval|Number
1346361|NCT01849848|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks||||Events|||Number
1346362|NCT01849848|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks||||participants|||Number
1346363|NCT01849848|Secondary|Adverse Events|All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.|up to around 44 weeks||||participants|||Number
1346364|NCT01849848|Secondary|Overall Survival (OS)|Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
1346365|NCT01849848|Secondary|Duration of Response (DOR)|From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
1346366|NCT01849848|Secondary|Time to Treatment Failure (TTF)|Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
1346367|NCT01849848|Secondary|Progression-Free Survival (PFS)|Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
1346368|NCT01849848|Secondary|Response Rate (CR+PR) Based on the Blade Criteria|"The criteria for PR based on the Blade are shown below.~PR requires 1. or all of the others:~Some, but not all, of the criteria for CR are fulfilled~≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks~Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks~For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy~≥50% reduction in the size of soft tissue plasmacytomas~No increase in size or number of lytic bone lesions"|up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
1346542|NCT01847547|Secondary|Incidence Rate of Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346369|NCT01849848|Secondary|Complete Response (CR) Based on the Blade Criteria|"The criteria for CR based on the Blade are shown below.~CR requires all of the followings:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas"|up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
1346370|NCT01849848|Secondary|Response Rate (sCR+CR) Based on IMWG Criteria||up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
1346371|NCT01849848|Primary|Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria|"The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below.~sCR: Fulfills CR criteria as well as all of the following conditions~Normal free light chain (FLC) ratio(κ/λ)~Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~CR: Fulfills all of the following criteria~Negative immunofixation of serum and urine M-protein~<5% plasma cells in bone marrow~Disappearance of any soft tissue plasmacytoma~VGPR: Fulfills at least one of the following criteria~Serum and urine M-protein detectable by immunofixation but not electrophoresis~≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine <0.1 g/24 hour~PR: Fulfills the following criteria~≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to < 0.2 g/24hours"|up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
1346372|NCT01849770|Secondary|Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication||||ratio||95% Confidence Interval|Number
1346373|NCT01849770|Secondary|Mean Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.~The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.~Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication||||units on a scale||95% Confidence Interval|Mean
1346374|NCT01849770|Secondary|Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication||||ratio||95% Confidence Interval|Number
1346375|NCT01849770|Secondary|Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication||||ratio||95% Confidence Interval|Number
1346376|NCT01849770|Secondary|Maximal Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.~The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.~Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication||||units on a scale||95% Confidence Interval|Mean
1346377|NCT01849770|Other Pre-specified|Change in Slow Vital Capacity (SVC) Score|The vital capacity (VC) (percent of predicted normal) will be determined, using the slow VC method. The SVC can be measured using conventional spirometers that have had a calibration check prior to subject testing. A printout from the spirometer of all SVC trials will be retained.|Week 0, Week 6, and Week 12 (or Early Termination Date)||||percent of predicted normal||95% Confidence Interval|Mean
1346378|NCT01849770|Other Pre-specified|Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16||||scores on a scale||95% Confidence Interval|Mean
1346379|NCT01849770|Secondary|Mean Weekly Cramp Frequency||Week 3-12, post titration of study medication||||cramps/week||95% Confidence Interval|Mean
1346380|NCT01849770|Secondary|Mean Cerebrospinal Fluid (CSF)/Plasma Ratio|The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.|Week 6 Visit (up to 6 hours post dose)||||ratio||Standard Deviation|Mean
1346381|NCT01849770|Secondary|Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (up to 6 hours post dose)||||µg*hr/mL||Standard Deviation|Mean
1346382|NCT01849770|Secondary|Peak Plasma Concentration (Cmax) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)||||pg/mL||Standard Deviation|Mean
1346383|NCT01849770|Secondary|Trough Plasma Concentration (Cmin) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)||||pg/mL||Standard Deviation|Mean
1346384|NCT01849770|Primary|Percentage of Participants That Discontinued Study Drug|Information on adverse effects of mexiletine will be determined at each visit by direct questioning of the subjects, clinical examination, review of concomitant medications, vital signs and laboratory test results.|Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16.||||percentage of participants|||Number
1346385|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 4|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
1346386|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 3|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
1346387|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 2|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
1346388|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 1|CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
1346389|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 4|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||letters||Standard Deviation|Mean
1346390|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 3|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||letters||Standard Deviation|Mean
1346391|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 2|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||letters||Standard Deviation|Mean
1346392|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 1|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with last observation carried forward (LOCF) imputation for missing values.|||letters||Standard Deviation|Mean
1346393|NCT01849692|Primary|Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28|"A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline:~Greater than or equal to 4 letter gain in BCVA at Day 14~Greater than or equal to 4 letter gain in BCVA at Day 28~Greater than or equal to 80 micron decrease in CSFT at Day 14~Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis."|Baseline, Day 14, Day 28|"This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, n is the number of subjects in each arm group."|||percentage of responders||90% Confidence Interval|Number
1346394|NCT01849588|Other Pre-specified|Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline|The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported.|2 years|AFP levels were not available for one participant.|||Participants|||Count of Participants
1346395|NCT01849588|Secondary|Overall Survival|Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date.|2 years||||months||Full Range|Mean
1346396|NCT01849588|Secondary|Time to Radiological Tumor Progression|Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date.|2 years|Study was terminated early due to slow accrual.|||months||Full Range|Mean
1346397|NCT01849588|Primary|Decline in HCV-RNA Level|Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.|up to 2 years||||Participants|||Count of Participants
1346449|NCT01849068|Primary|Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)||||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
1346398|NCT01849562|Primary|Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection.|To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1, the following criteria will be used: the number of subjects with discontinuations due to AEs, treatment emergent G3/G4 AEs, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs.|12 weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug. For this study, the safety population and the FA set were the same.|||participants|||Number
1346399|NCT01849562|Primary|Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment.|Incidence of SVR4 after the completion of dosing, reported as HCV RNA less than the lower limit of quantification (<LLOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo.|Four weeks after the completion of treatment|The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized subjects who received at least one dose of study drug and had at least one baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same.|||Percentage of Subjects with SVR4|||Number
1346400|NCT01849497|Secondary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|Full analysis set|||percent change||Standard Error|Least Squares Mean
1346401|NCT01849497|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4|Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.|Week 2 and Week 4|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1346402|NCT01849458|Secondary|Number of Study Participants With Re-tears|Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.|12 Months||||Participants|||Count of Participants
1346403|NCT01849458|Secondary|Number of Study Participants With Re-tears|Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.|6 Months||||Participants|||Count of Participants
1346404|NCT01849458|Secondary|Clinical Functional Outcome - WORC Index|Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.|12 Months||||Percentage of WORC Index||Standard Deviation|Mean
1346405|NCT01849458|Secondary|Clinical Functional Outcome - WORC Index|Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.|6 Months|One subject is missing data for this outcome measure thus a total of 49 subjects were analyzed in this section.|||Percentage of WORC Index||Standard Deviation|Mean
1346406|NCT01849458|Secondary|Clinical Functional Outcome - Adjusted Constant-Murley Score|Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.|12 Month||||scores on a scale||Standard Deviation|Mean
1346407|NCT01849458|Secondary|Clinical Functional Outcome - Adjusted Constant-Murley Score|Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.|6 Months|50 Participants|||scores on a scale||Standard Deviation|Mean
1346408|NCT01849458|Primary|Number of Participants With Device Associated Adverse Events|"The primary objective is to report the number of participants with device associated adverse events.~Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device."|12 Months||||Participants|||Count of Participants
1346409|NCT01849419|Secondary|Motivation to Socialize (Placebo)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session||||units on a scale||Standard Error|Mean
1346410|NCT01849419|Secondary|Motivation to Socialize (Oxytocin)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session||||units on a scale||Standard Error|Mean
1346411|NCT01849419|Secondary|Motivation to Socialize (MDMA)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session||||units on a scale||Standard Error|Mean
1346412|NCT01849419|Secondary|Cardiovascular Response to Placebo (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
1346413|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
1346414|NCT01849419|Secondary|Cardiovascular Response to MDMA (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
1346415|NCT01849419|Secondary|Cardiovascular Response to Placebo (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
1346416|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
1346417|NCT01849419|Secondary|Cardiovascular Response to MDMA (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
1346418|NCT01849419|Secondary|Cardiovascular Response to Placebo (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||bpm||Standard Error|Mean
1346419|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||bpm||Standard Error|Mean
1346420|NCT01849419|Secondary|Cardiovascular Response to MDMA (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||bpm||Standard Error|Mean
1346421|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346422|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346423|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346424|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346425|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346426|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346427|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346428|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346429|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
1346430|NCT01849419|Primary|Emotional Recognition (Placebo)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”~Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session||||percent intensity||Standard Error|Mean
1346431|NCT01849419|Primary|Emotional Recognition (Oxytocin)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”~Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session||||percent intensity||Standard Error|Mean
1346432|NCT01849419|Primary|Emotional Recognition (MDMA)|"Participants complete the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 “frames” progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to “press the space bar as soon as you know what expression is being displayed.” This ended the sequence and presented options of “angry,” “fearful,” “sad,” and “happy.”~Perception of expressions was quantified as the intensity (0–100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session||||percent intensity||Standard Error|Mean
1346433|NCT01849289|Secondary|Number of Treatment Emergent AEs (Adverse Events)|Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)|On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)|The SAS included all subjects receiving at least one dose of investigational product.|||number of events|||Number
1346434|NCT01849289|Secondary|Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes|A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.|Week 26|The FAS included all randomised subjects.|||participants|||Number
1346435|NCT01849289|Secondary|Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)|Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.|Week 26|The FAS included all randomised subjects. Missing data were imputed using LOCF. For 2 subjects in the IDeg OD arm it was not possible to estimate CV(%) due to missing data.|||percentage||Standard Deviation|Mean
1346436|NCT01849289|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. LOCF values are presented for this endpoint. 7 subjects were not included in the analysis.|||mmol/L||Standard Deviation|Mean
1346437|NCT01849289|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).|On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)|The Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1346438|NCT01849289|Primary|Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Last Observation Carried Forward (LOCF) values were presented for this endpoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1346439|NCT01849263|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from registration to the date of treatment discontinuation due to any reason. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Time from registration to the date of treatment discontinuation due to any reason, assessed up to 5 years|All patients beginning protocol treatment were included in this endpoint analysis.|||months||95% Confidence Interval|Median
1346440|NCT01849263|Secondary|Time to Subsequent Treatment|Time to subsequent treatment is defined as the time from registration to the date of initiation of subsequent treatment for lymphoma. The distribution of time to subsequent treatment will be estimated using the method of Kaplan-Meier.|Time from registration to the date of initiation of subsequent treatment for lymphoma, assessed up to 5 years|All patients beginning protocol treatment were included in this endpoint analysis.|||months||95% Confidence Interval|Median
1346441|NCT01849263|Secondary|Time to Response|Time to response is defined for all evaluable patients who have achieved a confirmed response as the time from the date of registration to the date at which the patient’s objective status is first noted to be a CR or PR.The median and 95% confidence interval will be calculated using the methods of Kaplan-Meier.|Time from the date of registration to the date at which the patient’s objective status is first noted to be a CR or PR, assessed up to 5 years|All patients reporting a response during treatment are included in this analysis.|||months||95% Confidence Interval|Median
1346442|NCT01849263|Secondary|Progression-free Survival|Progression-Free Survival is defined as the time from registration to documented progression or death due to any cause, whichever occurs first. Estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 5 years|All patients beginning protocol treatment are included in this endpoint.|||months||95% Confidence Interval|Median
1346443|NCT01849263|Secondary|Overall Survival|Overall Survival is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|Assessed up to 5 years|All patients beginning protocol treatment are included in this endpoint.|||months||95% Confidence Interval|Median
1346444|NCT01849263|Secondary|Duration of Response|"Duration of response is defined as the time from first evidence of a response to the first documented time of progressive disease (PD). Response and Progression were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma. > > A CR is defined as the disappearance of all evidence of disease. A PR is defined as ≥ 50% decrease in the sum of the products of dimensions (SPD) of up to 6 largest dominant masses; no increase in size of other nodes and regression on CT, and no increase in size of liver/spleen.Estimated using the method of Kaplan-Meier. >~> Progressive Disease (PD) is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir."|Time from the date at which the patient’s objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 5 years|All patients that reported a response during treatment are included in this analysis.|||months||95% Confidence Interval|Median
1346445|NCT01849263|Primary|Overall Response Rate|"Overall response rate defined as a partial response (PR) or complete response (CR) as the objective status at any time during treatment, evaluated using the Cheson et al. Revised Response Criteria for Malignant Lymphoma. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.~A CR is defined as the disappearance of all evidence of disease. A PR is defined as ≥ 50% decrease in the sum of the products of dimensions (SPD) of up to 6 largest dominant masses; no increase in size of other nodes and regression on CT, and no increase in size of liver/spleen."|Up to 5 years|All patients that began protocol treatment were included in this analysis.|||proportion of participants||95% Confidence Interval|Number
1346446|NCT01849068|Secondary|Change in Protein Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase are sufficient.||||||
1346447|NCT01849068|Secondary|Change in Intestinal Protein Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of LDL receptor is sufficient.||||||
1346448|NCT01849068|Secondary|Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)||||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
1346465|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: ADP|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.|||Percent change||Inter-Quartile Range|Median
1346450|NCT01848990|Secondary|Standard Deviation of Self-Monitoring Blood Glucose Values at 6 Months|Standard deviation of self-monitoring blood glucose values was calculated based on measurements taken within 15 minutes before a meal, 1 month and up to 6 months after study drug administration. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and had evaluable self-monitoring blood glucose data.|||mg/dL||Standard Error|Least Squares Mean
1346451|NCT01848990|Secondary|Mean Glucose Excursions at 6 Months|A 4-hour postprandial glucose excursion was measured for 3 meals after 1 month up to 6 months. For each of the 3 meals, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal (for measurements taken within 15 minutes before a meal). The average of all excursions is presented. Least Squares (LS) means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and had evaluable mean glucose excursion data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1346452|NCT01848990|Secondary|Rates of Hyperglycemia Events|Overall rates of hyperglycemia (defined as blood glucose >240 mg/dL and >300 mg/dL) were based on measurements after 1 month up to 6 months. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and whose average bolus insulin dose was within 15 minutes before a meal.|||events per participant per month|||Number
1346453|NCT01848990|Secondary|Rates of Hypoglycemia Events (HE)|Overall rates of hypoglycemia (defined as blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were based on measurements after 1 month up to 6 months. A severe HE was classified as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A nocturnal HE was classified as an event with a blood glucose of ≤70 mg/dL with start time between 2300 and 0600, inclusive. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|After Month 1 up to Month 6|Participants who received at least one dose of study drug and whose average bolus insulin dose was within 15 minutes before a meal.|||events per participant per month|||Number
1346454|NCT01848990|Primary|Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)||Baseline, 6 Months|Participants who received at least one dose of study drug and had evaluable HbA1c data.|||percentage of HbA1c||Standard Deviation|Mean
1346455|NCT01848977|Primary|Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved||||%*min||Standard Deviation|Mean
1346456|NCT01848977|Secondary|Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved|Before VOT. basline StO2 and SrO2 were recorded and compared each other. During VOT, minimum/maximum StO2 and SrO2 were also recorded and compared each other.|Until basline tissue oxygenation value was achieved||||percentage of oxyhemoglobin||Standard Deviation|Mean
1346457|NCT01848977|Primary|Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved||||%/min||Standard Deviation|Mean
1346458|NCT01848938|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)|A self-rated question that asks about the change experienced after treatment with 7 response options, ranging from “very much better” to “very much worse”.|three months|intention-to-treat analysis. Missing values at follow-up were replaced with a neutral value (i.e., no change).|||participants|||Number
1346459|NCT01848938|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).|||episodes per week||Inter-Quartile Range|Median
1346460|NCT01848938|Secondary|Patient Satisfaction|A self-rated question about if the current treatment was sufficient, with three response options|three months|Data for this outcome measure could only be collected for the smartphone treatment group.|||participants|||Number
1346461|NCT01848938|Secondary|Usage of Incontinence Aids|Usage of incontinence aids during the last 4 weeks.|three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).|||participants|||Number
1346462|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.|baseline, three months|intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
1346463|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity|baseline, three months|intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
1346464|NCT01848899|Primary|Thrombin Generation Test: After Coronary Angiography|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|1 hour|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.|||nM*minutes||Inter-Quartile Range|Median
1346543|NCT01847547|Secondary|Incidence Rate of Stroke or Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346466|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Arachidonic Acid|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.|||Percent change||Inter-Quartile Range|Median
1346467|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Epinephrine|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine|Baseline to 1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.|||Percent change||Inter-Quartile Range|Median
1346468|NCT01848899|Primary|Thrombin Generation Test: Baseline|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|baseline|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.|||nM*minutes||Inter-Quartile Range|Median
1346469|NCT01848847|Primary|Pain Scoring(VAS)|Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 –point visual analog scale (VAS) which means pain increases with increasing number|2 months||||units on a scale||Standard Deviation|Mean
1346470|NCT01848847|Secondary|Procedure Duration|Procedural time which will be measured in minutes|two months|||||||
1346471|NCT01848847|Secondary|Patient Acceptability and Pain Scoring|Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.|two months|||||||
1346472|NCT01848847|Primary|Ease of Cervical Entry|Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.|2 months||||units on a scale||Standard Deviation|Mean
1346473|NCT01848834|Other Pre-specified|Number of Participants With Log Fold Change From Baseline in Cytokines (Interleukin 10 [IL-10]) >1|IL-10 is an anti-inflammatory cytokine. The number of participants with a log fold change from Baseline in IL-10 >1 was to be presented. Protocol Amendment 03 (26 May 2015) removed the secondary objective of investigating the relationship between programmed cell death 1 (PD-1) inhibition and up-regulation of cytokines biomarkers predicting response (e.g. IL-10) from the protocol. No data were collected for this outcome measure.|Baseline and Week 8|The population was to consist of all randomized participants who: 1) received ≥1 dose of study treatment and 2) had a baseline IL-10 assessment, and 3) had a post baseline IL-10 assessment. No data were collected for this outcome measure.||||||
1346474|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 14 months)|The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1346475|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for Cohort B2 in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 34 months)|The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1346476|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were previously treated with cetuximab and platinum and experienced a CR or PR in the Cohorts B and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.|Every 8 weeks until disease progression (Up to approximately 27 months)|The population consisted of all Cohort B or B2 participants who progressed following cetuximab and platinum therapy and received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1346477|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were from the Asia Pacific region and experienced a CR or PR in Cohort D is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.|Every 8 weeks until disease progression (Up to approximately 30 months)|The population consisted of all Cohort D AP participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1346490|NCT01848366|Primary|Global Response Assessment (GRA)|The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.|3 months||||units on a scale||Full Range|Mean
1346478|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 HPV-positive Participants|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who had tumors which were HPV positive and who experienced a CR or PR in the combined Cohorts B2 and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 27 months)|The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1346479|NCT01848834|Primary|Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who experienced a CR or PR in Cohort B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 14 months)|The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1346480|NCT01848834|Primary|Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B & B2, C, and D)|Overall Response Rate (ORR) was defined as the percentage of participants who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentages of participants who experienced a CR or PR for Cohort A, Cohorts B and B2 participants, Cohort C and Cohort D are presented. Cohorts A, B, C and D enrolled participants with programmed cell death-ligand 1 (PD-L1) positive tumors; Cohort B2 enrolled participants regardless of PD-L1 expression.|Every 8 weeks until disease progression (Up to approximately 34 months)|The population consisted of all Cohort A, B, B2, C and D participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
1346481|NCT01848834|Primary|Number of Participants Discontinuing From Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. Some cases of clinical progression that led to discontinuation of study treatment were captured as AEs that led to discontinuation of study treatment.|Up to last dose of study treatment (Up to approximately 31 months)|The population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Number
1346482|NCT01848834|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.|Serious AEs: Up to 90 days after last dose of study treatment (Up to 34 months); nonserious AEs: Up to 30 days after last dose of study treatment (Up to 32 months)|The population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Number
1346483|NCT01848756|Secondary|Adverse Events by Severity and Relationship to Treatment|Number of patients experiencing adverse events by highest recorded severity and relationship to study tretament|Every 28 day cycle|All treated subjects|||participants|||Number
1346484|NCT01848756|Secondary|Ophthalmologic Changes From Baseline|Ophthalmologic assessments will be presented by cohort, study visit and dose. Number of subjects experiencing clinically relevant changes from baseline in any of these examinations will be presented using descriptive summary|Screening, end of Cycle 1, final visit|ll Treated Subjects|||participants|||Number
1346485|NCT01848756|Secondary|Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline|Descriptive summaries of vital signs, physical examination and clinical laboratory changes will be presented by treatment received.|Day 28 of each cycle|All Treated Subjects|||participants|||Number
1346486|NCT01848756|Secondary|Number of Patients With Adverse Events|Number of patients experiencing treatment emergent adverse events.|Day 28 of each cycle|All Treated Subjects|||participants|||Number
1346487|NCT01848756|Primary|Overall Survival|Time from start of treatment that patients remain alive.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination||||||
1346488|NCT01848756|Primary|Progression Free Survival|Time on treatment with at worst stable disease.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination||||||
1346489|NCT01848756|Primary|Objective Response Rate|The effect of SNX-5422 on tumor progression. Objective tumor responses (complete remissions plus partial remissions) and clinical benefit rate (complete remissions plus partial remissions plus stable disease at 6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 24 months from last patient entry|Per protocol population including all enrolled evaluable subjects.Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 6 months on study, the first analysis time point for this endpoint, at the time of study termination||||||
1346491|NCT01848288|Secondary|Aspiration Time|Aspiration Time indicated the amount of time the system was aspirating during the removal of the cataractous lens. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.|||seconds||Standard Error|Least Squares Mean
1346492|NCT01848288|Primary|Aspiration (ASP) Fluid Used|Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.|||grams||Standard Error|Least Squares Mean
1346493|NCT01848288|Primary|Cumulative Dissipated Energy|Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.|||percent-seconds||Standard Error|Least Squares Mean
1346494|NCT01848210|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events are any unwanted medical occurrences in an individual taking part in a clinical study who is receiving a pharmaceutical product. The adverse event does not have necessarily a causal relationship with the treatment. In this definition, any adverse or unwanted signals and symptoms, or findings that appear from the start or that deteriorate during the clinical study are also included, i.e. any intercurrent diseases (recently diagnosed concomitant diseases or symptoms), accidents and clinically relevant changes in clinical laboratory values.|Baseline to Week 16|Safety Population included all randomized participants who received study drug and had a least one post-Baseline safety assessment.|||participants|||Number
1346495|NCT01848210|Secondary|Overall Assessment by the Investigator|The investigator recorded their impression of the overall clinical picture at the end of the treatment period (Week 16), taking into account the clinical picture compared with the Baseline visit. Data is reported for the percentage of participants in each of the following assessment categories: worsening, unchanged, discreet improvement or accentuated improvement.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.|||percentage of participants|||Number
1346496|NCT01848210|Secondary|Change (Reduction) From Baseline in Local Complaint Severity|"Local Complaint Severity will be assessed using the Severity Score of Local Complaints that comprises 8 items: 1=tired legs, 2=heavy legs, 3= feeling of tension, 4=feeling of swelling, 5=aching legs, 6=tingling, 7=itching, 8=burning of soles of the feet.~Each item is classified with a Likert-type scale of 5 levels, where 0=absent, 1=low, 2=medium, 3=high, 4=very high.~A total score is calculated from the sum of the scores of all the 8 items and ranges from 0 (complaints absent) to 32 (very high severity)."|Baseline and Week 16|ITT population, all participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment). Last observation carried forward (LOCF).|||score on a scale||Standard Deviation|Mean
1346497|NCT01848210|Primary|Mean Change (Reduction) From Baseline in Volume of Reference Leg at Week 16|Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.|||milliliters (mL)||Standard Deviation|Mean
1346498|NCT01848184|Other Pre-specified|Other Relevant Data: Time of Mesh Positioning|The time of the mesh positioning during surgery|Per- operative||||min||Standard Deviation|Mean
1346499|NCT01848184|Other Pre-specified|Other Relevant Data: Operative Time|Operative time during surgery for all patient receiving PCO ventral patch|Per- operative||||min||Standard Deviation|Mean
1346500|NCT01848184|Other Pre-specified|Mesh Handling Ease of Use During Surgery|Ease of use (mesh handling and comfort of use). Surgeons were asked if they were satisfied or completely satisfied, unsatisfied or completely dissatisfied|Per- operative|Overal patients treated with PCO Ventral patch|||Participants|||Count of Participants
1346501|NCT01848184|Other Pre-specified|Summary of Risk Factors at Baseline|Summary of Risk factors at Baseline. Risk factors include: Smoker, Obesity, Diabetes T1 & T2, Cancer, Cardiovascular disease, Hypertension, COPD, Chronic desease requiring analgesic or corticoid consumption|Baseline|Number of patients with risk factors at baseline|||participants|||Number
1346502|NCT01848184|Other Pre-specified|Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months|Pain evaluation as determined by a 10-point pain intensity numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain). Scores reported at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months|Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)|The number analyzed includes participants who completed the NRS pain scale|||units on a scale||Standard Deviation|Mean
1346503|NCT01848184|Secondary|Recurrence Rate at 1, 6 and 12 Month Follow‐up|The number of participants with hernia recurrence at 1 month, 6 month and 12 month follow-up visit.|1, 6 and 12 month follow‐up.|The number analyzed reflects the number of participants who returned for 1 month, 6 month and 12 month follow-up visits.|||Participants|||Count of Participants
1346504|NCT01848184|Primary|Primary Hernia Recurrence Rate at 24 Month Follow‐up.|The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography.|24 month follow‐up|101 patients returned for 24 month Follow-Up Visit.|||Participants|||Count of Participants
1346505|NCT01848145|Secondary|Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.|Patients who received at least 1 dose of protocol treatment either Infusion #1 (300 mg), Infusion #2 (1000 mg) or Infusion #3 (2000 mg) are included in the assessment.|up to 28 weeks||||participants|||Number
1346508|NCT01848145|Secondary|Overall Response Rate (ORR)|Defined as the percent of patients having a complete or partial response (CR or PR) assessed by International Workshop on CLL Working Group (IWCLLWG) Diagnostic Criteria (Hallek et al., 2008). CR = (a) Peripheral blood lymphocytes below 4000/µl; (b) Absence of significant lymphadenopathy by physical exam or radiographic scans (c) No hepatomegaly or splenomegaly; (d) Absence of constitutional symptoms; and blood counts above specified values. PR = (a) Decreased blood lymphocytes by 50% or more from the value prior to therapy;(b) No increase in any lymph node, and no new enlarged lymph node. Progressive Disease (PD) = An increase in 50% or more in greatest determined diameter of any previous site. Stable Disease (SD) = No evidence of CR or PR and no evidence of progressive disease.|At weeks 12 and 28|All evaluable patients. 3 patients discontinued prior to assessment.|||percentage of patients|||Number
1346509|NCT01848145|Secondary|Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab|Defined as the actual mean infusion times, in minutes, for patients to complete a schedule of 3 infusions with the goal of completing Infusion #3 within 15 minutes of the planned 2-hour treatment time.|Week 1 - Days 1 and 3, and Week 2, Day 1|Includes all treated participants. 1 participant discontinued treatment after Infusion # 1 but prior to Infusion #2. 2 participants discontinued treatment after Infusion #2 but prior to Infusion #3|||minutes||Full Range|Mean
1346510|NCT01848145|Primary|Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment.|Defined as percent of patients who are able to complete the Day 8 (2000 mg IV Ofatumumab) infusion within 15 minutes of the planned 2-hour treatment goal.|At Week 2, Day 1 of therapy|Patients who completed Infusion #3 within the 2 hour treatment goal.|||percentage of participants|||Number
1346511|NCT01848067|Secondary|Number of Participants With a PSA Value Equal to or Greater Than 25%|Compared between the two patient subsets using the nonparametric Mann-Whitney test. A comparison of CTC counts between baseline and at progression for those who have progressed will be carried out using either a paired t test or the nonparameteric Wilcoxon matched pairs test.|Baseline up to 3 months||||Participants|||Count of Participants
1346512|NCT01848067|Primary|Phase II: Duration of Progression Free Survival According to the PCWG2 Criteria|The Kaplan-Meier product limit method will be used to estimate the probability distribution of progression free survival (PFS). The proportion of patients achieving at least a 50% decline from baseline will be reported with a 95% confidence interval. The results will be presented graphically using a waterfall plot.|12 weeks|The toxicity / efficacy ratio did not warrant further pursuing this treatment and the trial was terminated earlier after discussion with sponsor. Trial did not progress to Phase II.||||||
1346513|NCT01848067|Primary|Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1|Summarized with descriptive statistics.|Up to 21 days||||Participants|||Count of Participants
1346514|NCT01848054|Secondary|Retention in Treatment in the Full Analysis Population|Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥–10% in the number of patients retained in treatment on Day 3.|Day 3|Full analysis population; patients with missing data were excluded from the analysis|||participants|||Number
1346515|NCT01848054|Secondary|Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase)|"Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1346516|NCT01848054|Secondary|Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1346517|NCT01848054|Secondary|Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable|Predose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
1346518|NCT01848054|Secondary|AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive|"Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||score x hour||Standard Deviation|Least Squares Mean
1346519|NCT01848054|Secondary|AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||score x hour||Standard Deviation|Least Squares Mean
1346520|NCT01848054|Secondary|Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population|||score x hour||Standard Deviation|Least Squares Mean
1346521|NCT01848054|Primary|Retention in Treatment in the Per Protocol Population|Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥–10% in the number of patients retained in treatment on Day 3.|Day 3|Per protocol population|||participants|||Number
1346522|NCT01847885|Post-Hoc|30% Reduction in Pain Interference From Baseline to End of Treatment (EOT)|The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is “does not interfere” and 10 is “completely interferes” within the last week. The mean of these seven scores was calculated to obtain the pain interference score. The score at End of Treatment (EOT) was compared to the baseline score to determine the percentage of subjects who had a clinically significant (30% or greater) reduction in pain interference.|4 weeks (from baseline visit to EOT visit)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
1346523|NCT01847885|Post-Hoc|Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT)|"Subjects who reported an reduction of at least 30% in either pain intensity or pain interference from baseline to End of Treatment (EOT) using the Brief Pain Inventory (BPI) Short Form.~The pain intensity score is excerpted from BPI question 3, worst pain, taken from 7-day diaries. This scale ranges from 0 representing no pain to 10 representing worst pain. The median diary score at EOT was compared to the median baseline diary score to calculate the percentage of subjects who had at least a 30% reduction in pain intensity.~Pain interference was assessed using BPI question 9. Subjects rated the degree to which their pain interfered with seven facets of daily life on a scale of 0 to 10, where 0 is “does not interfere” and 10 is “completely interferes”. The mean of these 7 scores was calculated to obtain the pain interference score. The score at EOT was compared to the baseline score to determine the percentage of subjects who had at least a 30% reduction in pain interference."|4 weeks (from baseline visit to EOT visit)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
1346524|NCT01847885|Other Pre-specified|Performance of the Smartpatch System|A sponsor-developed Clinician Satisfaction Survey was administered to the Investigator(s) at each site performing lead placement and included questions pertaining to use of the Smartpatch device as well as the overall impression of the therapy.|At completion of study, approximately 2.5 years|"Count of participants represents Investigators responding to the survey rather than study participants."|||Participants|||Count of Participants
1346525|NCT01847885|Other Pre-specified|User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment|Subjects completed the sponsor-developed Subject Satisfaction Survey at the end of the 12-week post-treatment period. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.|12-week post-treatment|Safety set (Subjects who were implanted with a Smartpatch Lead)|||Participants|||Count of Participants
1346526|NCT01847885|Other Pre-specified|User Satisfaction With The Smartpatch System at End of Treatment|Subjects completed the sponsor-developed Subject Satisfaction Survey at the End of Treatment (EOT) visit. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.|End of Treatment (4-weeks of Treatment/Control)|Safety set (Subjects who were implanted with a Smartpatch Lead)|||Participants|||Count of Participants
1346527|NCT01847885|Secondary|Clinical Global Impression of Improvement at End of Treatment|The Blinded Evaluator rated each subject enrolled at their site using a question adapted from the Clinical Global Impression (CGI) scale, known as the Clinical Global Impression-Improvement scale (CGI-I). For the CGI-I, a Blinded Evaluator was asked to rate the subject’s total improvement compared to their condition at baseline. The CGI-I uses a 7-point scale (centered at 4) that ranges from “very much worse” to “very much improved”.|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment). The CGI-I was not completed for one subject in the treatment group.|||Participants|||Count of Participants
1346528|NCT01847885|Secondary|Change in Pain Medication Usage at End of Treatment|Subjects completed 7-day diaries, in which they listed all pain medications they took during the 7 days. A blinded third party medication committee reviewed medications collected for each 7-day diary period and scored medication changes, in comparison to the baseline diary medications as “no change” (no change in dosage or change is not clinically meaningful to impact pain outcomes), “increase” (clinically meaningful increase in medication that would impact pain outcomes), or “decrease” (clinically meaningful decrease in medication that would impact pain outcomes).|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
1346529|NCT01847885|Secondary|Patient Global Impression of Change at End of Treatment|The Patient Global Impression of Change (PGIC) scale was administered at EOT to assess subject perception of overall improvement and patient preferences. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from “very much worse” to “very much improved” relative to baseline.|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
1346544|NCT01847547|Secondary|Incidence Rate of Major Upper Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346727|NCT01844830|Secondary|Incidence of Adverse Events (AEs) by Age Group|Patients with AEs|from baseline to 24 hours following drug administration|Patients group by age|||Count of participants|||Number
1346530|NCT01847885|Secondary|Change From Baseline Average Pain Intensity at End of Treatment|"A diary was used in the study to capture daily average shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) and is stated as please rate your pain by circling the one number that best describes your pain on the average. BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The mean scores were calculated for each diary period. The mean diary score at End of Treatment (EOT) was compared to the mean baseline diary score to calculate the change in pain intensity."|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||scores on a scale||Standard Deviation|Mean
1346531|NCT01847885|Secondary|Change From Baseline Quality of Life at End of Treatment|The Medical Outcomes Study Short Form (SF-36v2) was administered at clinic visits to assess the impact of peripheral nerve stimulation on the subject’s health-related quality of life. The SF-36v2 is a generic health survey designed to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The 36 questions were grouped into two components: physical and mental. The survey was scored using norm-based scoring algorithm where a score of 0 indicates maximum disability and a score of 100 indicates no disability. Change in each component score was derived from End of Treatment score minus baseline score.|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||scores on a scale||Standard Deviation|Mean
1346532|NCT01847885|Secondary|Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment|"A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours. BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at 12 weeks post-treatment was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for 12 weeks post-treatment was compared to the group mean of the median scores for the control group at baseline."|Baseline, 12-wks post-treatment|Full analysis set|||scores on a scale||Standard Deviation|Mean
1346533|NCT01847885|Secondary|Change From Baseline Shoulder Pain Interference at End of Treatment|The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is “does not interfere” and 10 is “completely interferes” within the last week. The mean of these seven scores will be calculated to obtain the pain interference score.|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment).|||scores on a scale||Standard Deviation|Mean
1346534|NCT01847885|Primary|Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups|At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.|16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment|Safety set|||device related adverse events|||Number
1346535|NCT01847885|Primary|Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)|A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory – Short Form Question 3 (BPI-3) and is stated as “please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours”. BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.|Baseline, End of Treatment (4-weeks of Treatment/Control)|Full analysis set|||scores on a scale||Standard Deviation|Mean
1346536|NCT01847547|Secondary|Incidence Rate of Major Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346537|NCT01847547|Secondary|Incidence Rate of Major Extracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346538|NCT01847547|Secondary|Incidence Rate of Major Intracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346539|NCT01847547|Secondary|Incidence Rate of Stroke Uncertain Classification|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346545|NCT01847547|Secondary|Incidence Rate of Transient Ischemic Attack|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346546|NCT01847547|Secondary|Incidence Rate of Major Other Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346547|NCT01847547|Secondary|Incidence Rate of Major Urogenital Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346548|NCT01847547|Secondary|Incidence Rate of Major Lower Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346549|NCT01847547|Secondary|Incidence Rate of Pulmonary Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346550|NCT01847547|Secondary|Incidence Rate of Deep Vein Thrombosis|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346551|NCT01847547|Secondary|Incidence Rate of Venous Thromboembolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346552|NCT01847547|Secondary|Incidence Rate of Myocardial Infarction|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346553|NCT01847547|Primary|Incidence Rate of Major Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346554|NCT01847547|Primary|Incidence Rate of Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
1346555|NCT01847443|Primary|Cmax of Nicotine 4 mg Test and Reference Product|Cmax for 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post-dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||ng/mL||Standard Deviation|Mean
1346556|NCT01847443|Primary|Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product|Cmax for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||ng/mL||Standard Deviation|Mean
1346557|NCT01847443|Primary|AUC(0-t) of Nicotine 4 mg Test and Reference Product|AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1of 4 treatment sequences; took atleast one dose of study medication (both test and ref) in 2 mg dose and/or in 4 mg doses; did not have any AE assimilated to vomiting in first 4h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr*ng/mL||Standard Deviation|Mean
1346558|NCT01847443|Secondary|Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr*ng/mL||Standard Deviation|Mean
1346559|NCT01847443|Secondary|Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||1/hr||Full Range|Median
1346571|NCT01847196|Secondary|Device Performance||From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days||||device malfunctions|||Number
1346560|NCT01847443|Secondary|Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr||Full Range|Median
1346561|NCT01847443|Secondary|Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr||Full Range|Median
1346562|NCT01847443|Primary|Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product|AUC(0-t) for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr*ng/mL||Standard Deviation|Mean
1346563|NCT01847430|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|Serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Month 1)|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
1346564|NCT01847430|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
1346565|NCT01847430|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
1346566|NCT01847430|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50 mm.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
1346567|NCT01847430|Secondary|Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.|"Anamnestic response to the challenge dose was defined as:~At least (i.e. greater than or equal to ) 4-fold rise in post-vaccination anti-HBs antibody concentrations in subjects seropositive at the pre-vaccination time point Post-vaccination anti-HB antibody concentrations ≥10 mIU/mL in subjects seronegative at the pre-vaccination time point"|Prior to vaccination with the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||Participants|||Count of Participants
1346568|NCT01847430|Secondary|Antibody Titers Against Hepatitis B Virus|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% CIs.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
1346569|NCT01847430|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off values defined were ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.|Before (Day 0) and one month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||Participants|||Count of Participants
1346570|NCT01847430|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||Participants|||Count of Participants
1346572|NCT01847196|Primary|Number of Adverse Events Occuring for All Evaluable Subjects|All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.|From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days||||participants|||Number
1346573|NCT01847131|Secondary|The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline|Rhinitis medicamentosa is the rebound nasal congestion after prolonged use (>7 days) of topical nasal decongestant (eg. oxymetazoline). However, a previous study by Baroody FM et al (J Allergy Clin Immunol 2011;127:927-34) showed that using oxymetazoline together with intranasal steroid for 1 month did not increase rhinitis medicamentosa compared to placebo. So we give rhinitis patients in the treatment group with oxymetazoline and intranasal steroid for 1 month, then stop using oxymetazoline and come back for the last visit 2 weeks later to see which patients develop rebound nasal congestion (rhinitis medicamentosa).|6 weeks||||participants|||Number
1346574|NCT01847131|Primary|Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction|Primary outcome measure is the nasal congestion score measuring by visual analog scale (VAS) ranging from 1-10 (0 = no symptom and 10 = the most severe symptom) compared between treatment group and controlled group.|6 weeks||||units on a scale||95% Confidence Interval|Geometric Mean
1346575|NCT01847014|Primary|Incident Rate of Adverse Events (AEs).|Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.|From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).|Four participants represent the Extension Analysis Set, who transitioned from completion of SYMPHONY AC-055-401 to this open-label extension clinical trial.|||Participants|||Count of Participants
1346576|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of phone calls to physicians.|Up to 18 Month Visit-End of Study|ITT Population|||Phone Calls||Full Range|Median
1346577|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of hours per week caregivers spent caring for patients.|Up to 18 Month Visit-End of Study|ITT Population|||Hours Per Week||Full Range|Median
1346578|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of days per week of missed work because of health reasons.|Up to 18 Month Visit-End of Study|ITT Population|||Days Per Week||Full Range|Median
1346579|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of nights spent at the hospital.|Up to 18 Month Visit-End of Study|ITT Population|||Nights||Full Range|Median
1346580|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of unplanned inpatient hospitalizations, emergency room visits, outpatient hospitalizations, physician office visits.|Up to 18 Month Visit-End of Study|ITT Population|||Visits||Full Range|Median
1346581|NCT01846741|Secondary|Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from “Extremely Difficult” (5) to “Extremely Easy” (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery, the first day of EMU, the end of EMU, and the 6 month follow-up visit.~Overall Usability was calculated as percentage of the users who found the overall usability of system to be easy-2 or extremely easy-1."|Up to 6 Month Visit|ITT Population|||Percentage of Participants Rated 1 or 2|||Number
1346582|NCT01846741|Secondary|Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System|All adverse events (AEs) occurring during the study were collected and incidence rates tabulated by System Organ Class and Preferred Term utilizing MedDRA version 16.1 dictionary. The incidence profile was used to assess differences in near term tolerability rates relative to standard VNS Therapy.|From initial titration visit (approximately 2 weeks after implantation) up to End of Study|ITT Population|||Number of Participants|||Number
1346583|NCT01846741|Primary|Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration.|The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary.|Up to 18 Month Visit-End of Study|||||||
1346584|NCT01846741|Secondary|Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline|"AED load were collected and measured from baseline.The AED load is calculated as the sum of all ratios of the total daily dose of each medication taken on the day of the visit over the defined daily dose of the medication for the main indication according to the WHO database.~Positive median value indicates increased drug load."|Up to 18 Month Visit-End of Study|ITT Population|||Percent Change||Full Range|Median
1346585|NCT01846741|Secondary|Assess Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6,12 and 18 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the proportion of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 18 Month Visit-End of Study|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
1346728|NCT01844830|Secondary|Incidence of Adverse Events (AEs) by Dosage Cohort|Patients with AEs|from baseline to 24 hours following drug administration|Patients grouped by dosage cohort|||Count of participants|||Number
1346586|NCT01846741|Secondary|Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)|"Adult subjects (18 years and older) completed the Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-P) survey questionnaire at screening and safety follow-up visits. The range for QOLIE-31-P (Sub-domains) scale is 0-100. The higher the score the better quality of life.~Mean QOLIE-31-P scores at 3, 6, 12 and 18 months were compared to baseline. MIC Thresholds as defined in Simon Borghs, Christine de la Loge, Joyce A. Cramer, defining minimally important change in QOLIE-31-P scores."|Up to 18 Month Visit-End of Study|ITT Population|||Units on a Scale||Standard Deviation|Mean
1346587|NCT01846741|Secondary|Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.~Mean SSQ scores at 3, 6, 12 and 18 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire."|Up to 18 Month Visit-End of Study|ITT Population|||Units on a Scale||Standard Deviation|Mean
1346588|NCT01846741|Secondary|Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.~Negative median value means improvement."|Up to 18 Month Visit-End of Study|ITT Population|||units on a scale||Full Range|Median
1346589|NCT01846741|Secondary|Assess Characterization of Seizures (Duration and Cessation)|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population|||Percent of Seizures Ended During Stim|Participants||Number
1346590|NCT01846741|Secondary|Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods|"Each day in the EMU, subjects exercised for up to 3 minutes stepping up and down at a submaximal effort level on a step stool. Subject's resting heart rate was compared with the calculated 85% of the patient’s age-predicted maximum heart rate. This calculated heart rate was then used as termination criteria for the step test.~Non-Seizure Detection Rate (previously known as Potential False Positive Rate) is defined as the total number of non-seizure detections summed for the group divided by the total evaluable monitoring time during the EMU. The non-seizure detection rate per hour was calculated at the various tachycardia detection settings for all subjects during EMU and during exercise activities (stair stepper)."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population. 5 participants analyzed for >=70%, 4 for >=60% setting, 8 for >=50% setting, 2 for >=40% setting, 1 for the >=30% setting.|||detections per hour||95% Confidence Interval|Number
1346591|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.|||Percent of True Positive Seizures||95% Confidence Interval|Number
1346592|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define electrographic seizure onset times. Seizure onset times were then compared with observed M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. Threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). No subjects were assigned to settings 3 and 6 that had seizures with a corresponding heart rate increase of >= 50% and >= 20%, respectively. Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.|||Percent of True Positive Seizures||95% Confidence Interval|Number
1346593|NCT01846741|Secondary|Summary of Seizures Reported by Investigators and Triple Review|"Seizure events were recorded during the EMU stay (only Automatic Stimulation Mode aka AutoStim ON) using vEEG and ECG to evaluate tachycardia detection algorithm performance. The threshold for the AutoStim feature (20-70%) was programmed for each subject, based upon the historical ictal elevation in heart rate for that subject, requiring the corresponding heart rate elevation above that of a moving baseline window.~Number of seizures observed and reported by investigators during the EMU stay (several subjects had more than one type of seizure) were collected and also reviewed by three (3) independent and blinded reviewers for confirmation. Additionally, the reviewers identified new seizures while reviewing the study EMU stay vEEG."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population: Consists of all patients in the safety population who have any EMU performance recorded data and experienced any seizures.|||Number of Seizures|||Number
1346594|NCT01846702|Secondary|Number of Participants Developing Anti-LY3084077 Antibodies|The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.|Pre-dose, Up to Day 190|All randomized participants who received at least one dose of study drug and had evaluable baseline and postbaseline antibody titers.|||participants|||Number
1346595|NCT01846702|Secondary|PD: Change From Baseline to Day 2 in Fasting Glucagon|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Up to Day 2|All randomized participants who received at least one dose of study drug and have evaluable fasting glucagon data.|||pmol/L||Standard Error|Least Squares Mean
1346596|NCT01846702|Secondary|PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Day 2|All randomized participants who received at least one dose of study drug and had evaluable incremental glucose AUC before and after a standard meal data.|||millomole*hour/Liter (mmol*h/L)||Standard Error|Least Squares Mean
1346597|NCT01846702|Secondary|PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Day 2|All randomized participants who received at least one dose of study drug and had evaluable C-peptide AUC before and after a standard meal data.|||picomole*hour/Liter (pmol*h/L)||Standard Error|Least Squares Mean
1346598|NCT01846702|Secondary|PD: Change From Baseline in Weight||Baseline, Up to Day 15|Zero participants had weight measured and therefore change from baseline in weight was not calculable across all arms.||||||
1346599|NCT01846702|Secondary|PD: Change From Baseline in Fasting Insulin|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Up to Day 15|All randomized participants who received at least one dose of study drug and had evaluable fasting insulin data.|||picomole/Liter (pmol/L)||Standard Error|Least Squares Mean
1346600|NCT01846702|Secondary|Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides|Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Up to Day 15|All randomized participants who received at least one dose of study drug and had evaluable fasting triglycerides data.|||percent||Standard Deviation|Least Squares Mean
1346601|NCT01846702|Secondary|PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077||Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1346602|NCT01846702|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077||Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||microgram*hour/milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1346603|NCT01846702|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Pre-dose, Up to Day 190|All randomized participants who received at least one dose of study drug.|||participants|||Number
1346604|NCT01846507|Secondary|Change From Baseline Menses for Ferritin Lab Value|Ferritin lab value normal range is 7 ng/mL to 142 ng/mL. Values in the range of 7ng/mL to 142 ng/mL would be considered normal Ferritin values. A score lower than the normal range (below 7 ng/mL) would indicate a worse outcome. Unit of measure is ng/mL.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||ng/dL||Full Range|Mean
1346605|NCT01846507|Secondary|Change From Baseline Menses for Hemoglobin Lab Value|Hemoglobin lab value normal range is 12 g/dL to 16 g/dL. Values in the range of 12 g/dL to 16 g/dL would be considered normal Hemoglobin values. A score lower than the normal range (below 12 g/dL) would indicate a worse outcome. Unit of measure is g/dL.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||gm/dL||Full Range|Mean
1346606|NCT01846507|Secondary|Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores|Pictorial Blood Assessment Chart (PBAC) scores - participant assessment of menstrual blood loss during menses using a pictorial chart to score menstrual blood loss. Pictorial scores range from 1 point for mild soaking of a pad/tampon, 5 points for moderate soaking of a pad/tampon, 10 points for severe soaking of a pad/tampon, and 5 points for each episode of flooding and for each blood clot larger than a quarter in size. Lower values indicate a better outcome (less blood loss). Unit of measure is a total computed score (all points during the menses from the pictorial chart added together).|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||PBAC score||Full Range|Mean
1346607|NCT01846507|Secondary|Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities|Menorrhagia Impact Questionnaire (MIQ): Question 4 - participant perceived limitation of social or leisure during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being social or leisure activities not at all limited and 5 being social or leisure activities limited extremely). Lower values indicate a better outcome (less limitation of social or leisure activities). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||Response scale||Full Range|Mean
1346608|NCT01846507|Secondary|Change From Baseline Menses for Participant Perceived Limitation in Physical Activities|Menorrhagia Impact Questionnaire (MIQ): Question 3 - participant perceived limitation in physical activities during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being physical activities not at all limited and 5 being physical activities extremely limited). Lower values indicate a better outcome (less limitation of physical activities). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||Response scale||Full Range|Mean
1346609|NCT01846507|Secondary|Change From Baseline Menses for Participant Perceived Limitation of School Attendance|Menorrhagia Impact Questionnaire (MIQ): Question 2 - participant perceived limitation of school attendance during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being school attendance not at all limited and 5 being school attendance limited extremely). Lower values indicate a better outcome (less limitation of school attendance). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||Response scale||Full Range|Mean
1346610|NCT01846507|Primary|Change From Baseline Menses for Participant Perceived Blood Loss|Menorrhagia Impact Questionnaire (MIQ): Question 1 - participant perceived blood loss during most recent menses. Scale ranges from a score of 1 to 4 (with 1 being light blood loss and 4 being very heavy blood loss). Lower values indicate a better outcome (less blood loss during menses). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||Response scale||Full Range|Mean
1346611|NCT01846455|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone|Apparent volume of distribution during terminal phase (only for buprenorphine and naloxone), calculated as Dose/(λz • AUC0-inf).|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1346612|NCT01846455|Primary|Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone|Apparent body clearance (only for buprenorphine and naloxone), calculated as Dose/AUC0-inf.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1346613|NCT01846455|Primary|Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|Terminal elimination half-life, calculated as ln(2)/λz. The terminal phase elimination half-life was calculated over a period of at least 2 half-lives.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||hours||Geometric Coefficient of Variation|Geometric Mean
1346614|NCT01846455|Primary|Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|For the determination of λz, only those data points judged to describe the terminal log-linear decline resulting in an adjusted coefficient of determination value (R2) > 0.7 were used in the regression. A minimum of 3 data points were used in calculating λz.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
1346615|NCT01846455|Primary|Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"Calculated as:~(AUC0-inf - AUC0-last)/AUC0-inf * 100~AUC0-inf, apparent body clearance (CL/F), and apparent volume of distribution during terminal phase (Vz/F) would not have been reported if %AUCextrap was > 20%."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||percentage of AUC0-inf||Standard Deviation|Mean
1346616|NCT01846455|Primary|Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||hours||Full Range|Median
1346617|NCT01846455|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||hours||Full Range|Median
1346618|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"The extrapolation to infinity was done using the terminal phase.~AUC0-inf = AUC0-last + Ct/λz~Where Ct was the last observed quantifiable concentration and λz was the apparent terminal phase elimination rate constant."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1346619|NCT01846455|Primary|Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1346620|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis:~AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1346621|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Color|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
1346622|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial surface thickness(one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
1346623|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Epithelial Integrity|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
1346624|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Secretions|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
1346625|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe dyspareunia as their Most Bothersome Symptom of vulvovaginal atrophy (VVA) and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||units on a scale||Standard Error|Mean
1346626|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.|A pH strip was applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||pH||Standard Error|Mean
1346627|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||percentage of superficial cells||Standard Error|Mean
1346747|NCT01844765|Secondary|Event Free Survival|Event Free Survival is defined as the time from the date of first study drug intake to the first occurrence of any of the following loss of CHR, loss of MCyR ( PCyR + CCyR), progression to AP/BC (from CP) or to BC (from AP), or death from any cause. (Including events only during treatment)|up to 66 cycles||2021-10-31|10/2021||||
1346628|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||percentage of parabasal cells||Standard Error|Mean
1346629|NCT01846416|Secondary|Minimum Plasma Concentration (Cmin) for Atezolizumab||Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16|Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1346630|NCT01846416|Secondary|Maximum Plasma Concentration (Cmax) for Atezolizumab||Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1|"Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points.~Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort."|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1346631|NCT01846416|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.|||months||95% Confidence Interval|Median
1346632|NCT01846416|Secondary|Percentage of Participants With Death|Participants were followed for survival throughout the study.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.|||percentage of participants|||Number
1346633|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6 and Month 12 According to Modified RECIST|Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Months 6 and 12|Efficacy-evaluable population.|||percentage of participants|||Number
1346634|NCT01846416|Secondary|PFS According to Modified RECIST|PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||months||95% Confidence Interval|Median
1346635|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to Modified RECIST|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||percentage of participants|||Number
1346636|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6 and Month 12 According to RECIST v1.1|Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Months 6 and 12|Efficacy-evaluable population.|||percentage of participants|||Number
1346637|NCT01846416|Secondary|Progression-Free Survival (PFS) According to RECIST v1.1|PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||months||95% Confidence Interval|Median
1346638|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to RECIST v1.1|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||percentage of participants|||Number
1346648|NCT01846299|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline (BL), month 1 through month 6, month 1 through month 12|The FAS was used for this analysis. The FAS included randomized participants who received at least one dose of study medication.|||letters||Standard Deviation|Mean
1346639|NCT01846416|Secondary|Percentage of Participants With 6-Month Duration of Objective Response|Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.|Month 6|Efficacy-evaluable population with a confirmed objective response.|||percentage of participants|||Number
1346640|NCT01846416|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population with a confirmed objective response.|||months||95% Confidence Interval|Median
1346641|NCT01846416|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)|Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population.|||percentage of participants||95% Confidence Interval|Number
1346642|NCT01846416|Primary|Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs, and all new measurable lesions to baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study.|||percentage of participants||95% Confidence Interval|Number
1346643|NCT01846299|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|12 months|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.|||Number of primary reasons|Participants||Number
1346644|NCT01846299|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to Month 12, the maximum number of retreatments was 5.|Month 6, month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.|||Participants|||Number
1346645|NCT01846299|Secondary|Number of Participants With Ranibizumab Treatments|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.|||Participants|||Number
1346646|NCT01846299|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||Participants|||Number
1346647|NCT01846299|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6 , Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||Participants|||Number
1346649|NCT01846299|Secondary|Number of Participants Requiring Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The FAS was used for this analysis. The FAS included all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1346650|NCT01846299|Secondary|Number of Participants With Presence of Active Macular Edema (ME) Leakage|The presence of active ME leakage was assessed by fluorescein angiography (FA).|Month 2|The FAS was used this analysis. The FAS included randomized participants who received at least one dose of study treatment.|||Participants|||Number
1346651|NCT01846299|Secondary|Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline|The presence of subretinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
1346652|NCT01846299|Secondary|Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
1346653|NCT01846299|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||microliters (ul)||Standard Deviation|Mean
1346654|NCT01846299|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||micrometers (um)||Standard Deviation|Mean
1346655|NCT01846299|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||letters||Standard Error|Least Squares Mean
1346656|NCT01846299|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 2|Full analysis set: The full analysis set included all randomized participants who received at least one dose of study treatment.|||letters||Standard Error|Least Squares Mean
1346657|NCT01846221|Secondary|Number of Spontaneous Vaginal Deliveries|Mode of delivery: spontaneous vaginal or instrumental vaginal versus cesarean.|Upon delivery (approximately up to 8 hours from baseline)||||spontaneous vaginal deliveries|||Number
1346658|NCT01846221|Secondary|Neonatal Apgar Score|The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.|1 minute and 5 minutes post delivery||||Apgar score||Full Range|Mean
1346659|NCT01846221|Secondary|Maternal Heart Rate|Heart rate will be measured at different timepoints.|Baseline, 30 Minutes post epidural administration|48 out of 51 participants were included from the Fentanyl group due to 4 participants did not have heart rate taken at 30 minutes.|||beats per minute (BPM)||Full Range|Mean
1346660|NCT01846221|Secondary|Maternal Systolic Blood Pressure|Blood pressure will be measured at different timepoints.|Baseline, 30 Minutes post epidural administration|46 out of 47 participants were included from the Clonidine group due to 1 participant did not have blood pressure taken at 30 minutes. 48 out of 51 participants were included from the Fentanyl group due to 3 participants did not have blood pressure taken at 30 minutes.|||mm Hg||Full Range|Mean
1346661|NCT01846221|Primary|Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection|Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. ‘Success’ is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)|Baseline, 15 Minutes post epidural administration|3 subjects in the Clonidine group were not included in the analysis due to the following reasons: 2 catheter failures, 1 age exclusion.|||Participants|||Count of Participants
1346662|NCT01846104|Secondary|Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).|||participants|||Number
1346663|NCT01846104|Secondary|Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).|||Subjects with Total ELISA IgG (≥ 1:500)|||Number
1346664|NCT01846104|Primary|Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.||Six months|All statistical analysis of safety data was conducted using 4 subjects at every time point except Day 180 (for which there were 3 subjects).|||participants|||Number
1346665|NCT01846039|Secondary|Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others||Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
1346666|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)|Participants assessed their satisfaction with the study drug (VOLUMA) treatment at Days 113, 239 and 421 using the TSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants satisfied or very satisfied with study drug treatment is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
1346667|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)|Participants assessed their satisfaction with the appearance of their nose at Days 113, 239 and 421 using the NSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants who rated themselves as satisfied or very satisfied is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
1346668|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
1346669|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician|The independent central evaluating physician evaluated the improvement of the participant’s nose compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
1346670|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
1346671|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113|The independent central evaluating physician evaluated the improvement of the participant’s nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
1346672|NCT01845974|Primary|Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements|The objective of this pilot study is to investigate the use of a lower flow catheter (ThermoCool® SF NAV Catheter, Biosense Webster, Inc. Diamond Bar, CA, eluting 8-15ml/minute during RF lesion delivery) vs. a higher flow catheter (ThermoCool® catheter, same manufacturer, eluting 17-30 ml/minute), Outcomes are measured by number of Participants with Hemodynamic, Electrolyte, and Electrophysiologic Derangements, is reported. This was measured as participants requiring electrolyte replacement, if the BP dropped below 100 mm in CICU or if participants sustained atrial tachyarrhythmias|Observation period is up to the 24 hours post procedure||||Participants|||Count of Participants
1346673|NCT01845831|Secondary|Hospital Mortality Rate|Mortality is defined as death occurring during admission.|Duration of Hospitalization (Up to 10 Days)||||participants|||Number
1346674|NCT01845831|Secondary|Acute Renal Failure Rate|Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment > 0.5 mg/dL from baseline).|Duration of Hospitalization (Up to 10 Days)||||participants|||Number
1346675|NCT01845831|Secondary|Length of Hospital Stay|Length of hospital stay in days.|Duration of Hospitalization (Up to 10 Days)||||days||Inter-Quartile Range|Median
1346676|NCT01845831|Secondary|Total Daily Insulin Dose|Daily insulin requirement (units per day).|Duration of Hospitalization (Up to 10 Days)||||units per day||Standard Error|Mean
1346677|NCT01845831|Secondary|Number of Participants With a Hypoglycemic Event|The number of participants who had a hypoglycemic event during hospitalization.|Duration of Hospitalization (Up to 10 Days)||||Participants|||Count of Participants
1346678|NCT01845831|Primary|Change in HbA1C|The mean HbA1C measured at 3 months and 6 months post hospitalization. HbA1C is an indicator of diabetes control; below 6.0% is normal, 6.0% to 6.4% indicates prediabetes, and 6.5% or over indicates diabetes.|Post Hospital Discharge Month 3, Month 6|253 subjects who participated in the inpatient phase and were invited to complete the outpatient phase.|||percent||Standard Deviation|Mean
1346679|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
1346680|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
1346681|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
1346682|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
1346687|NCT01845636|Secondary|Measurement of Everyday Cognition (Ecog)|"This instrument has 40 items, takes 20 minutes to administer, and focuses on functional correlates of cognitive deficits. This assessment asks the study informant to rate the participant's ability to perform certain tasks with the domains of Memory, Language, Visual-spatial and Perceptual Abilities, Executive Functioning: Planning, Executive Functioning: Organization, and Executive Functioning: Divided Attention. The informant is asked to compare functioning from 10 years prior to the time of testing. The Everyday Cognition measure uses the sum score of all of the subscales, and the items are reverse coded (i.e., 1= Better or no change, 2=Questionable/occasionally worse, 3=Consistently a little worse, 4=Consistently much worse), meaning that lower scores are better. Reported total scores range from 39 (Better or no change) to 156 (Consistently much worse)."|Week 0, Week 4, Week 8, Week 26, Week 52||||units on a scale||Standard Deviation|Mean
1346688|NCT01845636|Secondary|Pfeffer Functional Activities Questionnaire (FAQ)|"FAQ is a widely used 10-item instrument that takes 3 minutes to administer and focuses on instrumental, social and cognitive functioning. The assessment is completed by a study informant - typically a caregiver able to report best on the patient's current ability. The instrument assesses the patient's current ability, at the point of testing and through the past month, in these various domains. The total score is described as the cumulative scores of each item, ranging from 0 - No help needed to 3 - No, unable to do. More impairment is indicated by higher scores. The reported total score range is from 0 (no impairment score) to 30 (maximum impairment score)."|Week 0, Week 4, Week 8, Week 26, Week 52||||units on a scale||Standard Deviation|Mean
1346689|NCT01845636|Secondary|Total Number of Errors Measured Using the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)|The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. The ADAS-Cog is not a timed test and the participant's score does not depend on how rapidly the test is completed. The ADAS-Cog total score is based on the total number of errors made in the test by the participant. Therefore, a lower total score indicates a higher cognitive performance. The total score ranges from 0 to 95 and is determined by summing the errors from 12 subscales. The total score, indicating number of errors made, is the number that is reported at each timeframe.|Week 0, Week 8, Week 26, Week 52||||Errors||Standard Deviation|Mean
1346690|NCT01845636|Primary|Selective Reminding Test (SRT)|The Selective Reminding Test (SRT) is a 12-item test of verbal learning and memory. To administer, the researcher will read aloud a list of 12 words. The participant repeats each word aloud to ensure that the word was heard correctly. Immediately following the reading of all 12 words, the participant is asked to recall as many words as possible within the one minute time limit. The participant is then reminded of the words they did not say and asked to recall the list again. This process is repeated for 6 trials. The total immediate recall is the total number of words recalled by the participant from all 6 trials. This is the number that is reported. Lower scores indicate fewer words recalled and a poorer performance.|Week 0, Week 8, Week 26, Week 52||||Words||Standard Deviation|Mean
1346691|NCT01845220|Primary|Mean Area of Skin Erythema (Skin Redness)|For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported.|mean up to 2 hours|Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis.|||centimeters^2||95% Confidence Interval|Mean
1346692|NCT01845155|Secondary|Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)||the average time period was 3 months||||Hz||Standard Deviation|Median
1346693|NCT01845155|Primary|Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment|Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.|average time period was 3 months||||absolute TF-score change||Standard Deviation|Mean
1346694|NCT01845103|Secondary|Major Adverse Coronary and Cerebrovascular Events (MACCE)|"MACCE includes:~Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF"|30 day||||percentage of participants|||Number
1346695|NCT01845103|Primary|Mortality||30 day||||percentage of participants|||Number
1346696|NCT01845077|Primary|Cmax of Metformin|Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1346697|NCT01845077|Primary|AUC0-tz of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346748|NCT01844765|Secondary|Pharmacodynamics|BCR-ABL transcript levels determined with standard protocols in peripheral blood and bone marrow for all time points with available data|up to 66 cycles||2021-10-31|10/2021||||
1346698|NCT01845077|Secondary|AUC0-infinity of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346699|NCT01845077|Secondary|AUC0-infinity of Linagliptin|Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1346700|NCT01845077|Primary|Cmax of Linagliptin|Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1346701|NCT01845077|Primary|AUC0-72 of Linagliptin|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1346702|NCT01845025|Secondary|Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)|Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (< 24 hours); Hospital admission or Emergency department visit (> 24 hours).|Week 4, Week 12, and Week 26|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||unplanned visits|||Number
1346703|NCT01845025|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ – 6) Total Score at Week 26|Change from baseline in Asthma control Questionnaire (ACQ – 6) total score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a total score of 0 corresponds to no impairment and a total score of 6 corresponds to maximum impairment.|baseline and 26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||total score on a scale||Standard Deviation|Mean
1346704|NCT01845025|Secondary|Percentage of Days With no Symptoms at 26 Weeks|Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
1346705|NCT01845025|Secondary|Percentage of Days With no Rescue Medication Use at 26 Weeks|Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
1346706|NCT01845025|Secondary|Percentage of Days With Nighttime Awakenings at 26 Weeks|Percentage of days with nighttime awakenings during the treatment period (26 weeks)|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
1346707|NCT01845025|Secondary|Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks|The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
1347148|NCT01838863|Other Pre-specified|Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock|Haemoglobin (Hb) level in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||g/dL||Inter-Quartile Range|Median
1346708|NCT01845025|Secondary|Percentage of Days of School/Work Missed at 26 Weeks|The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
1346709|NCT01845025|Secondary|Number of Asthma Exacerbations at 26 Weeks|Number of asthma exacerbations events|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||events||Standard Deviation|Mean
1346710|NCT01845025|Primary|Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks|The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 * n patients with any events / total N patients in treatment group.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||number of occurences|||Number
1346711|NCT01844895|Secondary|Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.|Serum samples for immunogenicity were evaluated for presence of anti-abatacept antibodies using a validated bridging ECL on Day 29 and Day 113. The ECL assay differentiated between 2 antibody specificities: the immunoglobulin (Ig) G and/or junction region and cytotoxic leukocyte antigen 4 (CTLA4) and possibly Ig. A positive immunogenicity response relative to baseline was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value.|Days 29 and 113|A subset of the treated analysis population for whom at least 1 immunogenicity sample was collected and assessed for serum anti-abatacept antibodies, were summarized.|||participants|||Number
1346712|NCT01844895|Secondary|Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken at 0 hour (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy. Blood samples for PK were taken at 0 hour (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL).|Days 22, 29, 57, 85, 106, and 113|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector and with Cmin obtained appropriately (7 days + or -3 days after the previous dose).|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1346713|NCT01844895|Secondary|Geometric Mean of Area Under Serum Concentration-time (AUC) During a Dosing Interval (TAU) of Abatacept During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 106 at 0 h (predose), Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) where TAU = 168 hours was calculated in µg*h/mL|Days 22, 24, 25, 26,29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346714|NCT01844895|Secondary|PK Analysis: Median Time to Achieve Cmax (Tmax) During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Tmax was measured in hours (h).|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110,113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.|||h||Full Range|Median
1346729|NCT01844830|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window|Patients are grouped by age|||Participants|||Count of Participants
1346715|NCT01844895|Secondary|PK Analysis: Geometric Mean of Maximum Observed Serum Concentration (Cmax) of Abatacept During the Sampling Period Between Substudy Days 22 and 29 for the Prefilled Syringe and Between Substudy Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Cmax was measured in μg/mL.|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1346716|NCT01844895|Primary|Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113)|Abatacept SC was self-administered with a prefilled syringe every 7 days for the first 4 weeks until Day 29; Blood samples for PK were taken pre-dose (0 hour) on Days 29 and 113. Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL). Adjusted geometric mean and 90% confidence interval (CI) are presented.|Day 29, Day 113|The primary PK analysis population is a subset of the Treated Analysis population with (1) viable Cmin data on both substudy Days 29 and 113 (2) no missed Abatacept dose during the substudy period.|||μg/mL||90% Confidence Interval|Geometric Mean
1346717|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who had no major protocol deviations (CE population).|||participants|||Number
1346718|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who received at least 1 dose of study drug (MITT population).|||participants|||Number
1346719|NCT01844856|Primary|Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after the first dose of study drug|All randomized participants who had baseline bacterial pathogens that cause cIAI and against at least one of which the investigational drug has in vitro antibacterial activity (micro-ITT population).|||participants|||Number
1346720|NCT01844830|Secondary|Results of Naris Examination (NE) - Bleeding||120 minutes post drug administration||||Participants|||Count of Participants
1346721|NCT01844830|Secondary|Results of Naris Examination (NE) - Inflammation||120 minutes post drug administration||||Participants|||Count of Participants
1346722|NCT01844830|Secondary|Results of Naris Examination (NE) - Color|The investigators performed a visual inspection and evaluated the treatment naris for color of the mucosa. The investigator determined what color (Pink, Slightly Red, Red) best matched and recorded the results.|120 minutes post drug administration||||Participants|||Count of Participants
1346723|NCT01844830|Secondary|Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 24 hours following drug administration||||mmHg||Standard Deviation|Mean
1346724|NCT01844830|Secondary|Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 24 hours following drug administration||||mmHg||Standard Deviation|Mean
1346725|NCT01844830|Secondary|Maximum Change From Baseline in Heart Rate||from baseline to 24 hours following drug administration||||bpm||Standard Deviation|Mean
1346726|NCT01844830|Secondary|Results of Naris Examination (NE) - Patency and Ulcerations|"The investigators evaluated the treatment naris for patency and ulcerations.~Patency was evaluated as followed: The nostril not used for dosing study drug was manually occluded and the subject was asked to sniff gently. Airflow in the naris was used to determine if it was patent (yes) or not (no).~For ulcers, the investigators performed a visual examination for the presence of ulcers and recorded if they were present (yes) or not (no)."|120 minutes post drug administration||||Participants|||Count of Participants
1346730|NCT01844830|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window|Subjects were in only 1 of 3 dosage cohort. Either 100 µL, 200 µL, or 400 µL.|||Participants|||Count of Participants
1346731|NCT01844830|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window||||Participants|||Count of Participants
1346732|NCT01844817|Secondary|Objective Response Rate|Objective response rate defined as the percent of patients having a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=complete disappearance of all target lesions. PR=decrease in baseline of 30% or more of the diameter(s) of all target lesions.|Every 8 weeks for up to 2 years|Includes Intent-to-Treat Population: all subjects enrolled and randomized|||percentage of participants|||Number
1346733|NCT01844817|Secondary|Progression-Free Survival|The time (in months) that patients are progression-free, assessed from date of randomization to date of first documented disease progression or date of death from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.|Every 8 weeks up to 2 years|Intent-to-Treat Population: all subjects enrolled and randomized|||months||95% Confidence Interval|Median
1346734|NCT01844817|Primary|Overall Survival|Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.|Up to 2 years|Includes Intent-to-Treat Population: all subjects enrolled and randomized|||months||95% Confidence Interval|Median
1346735|NCT01844778|Secondary|Number of Participants With Post-inhalation Bronchospasm|Bronchospasm was defined as the relative decrease of 20% or more in forced expiratory volume in 1 second (FEV1) percent predicted from pre-dose to 15 to 45 minutes post-dose.|days 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day.|||Participants|||Number
1346736|NCT01844778|Secondary|Minimum Inhibitory Concentration (MIC) - MIC50 and MIC90 Tobramycin Values|MIC50/90 is the lowest concentration required to inhibit 50%/90% of the isolates tested. The MIC50/90 of a range of antibiotics for P.aeruginosa was determined at the start and end of each treatment cycle, and at the end of the off-treatment period of the second cycle.|days 1, 28, 57, 84, 112|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day. The number of isolates tested = m.|||ug/mL|||Number
1346737|NCT01844778|Secondary|Number of Participants With Any Contaminated Delivery Device|Devices used to administer the drugs (the T-326 inhaler and nebulisers) were swabbed for contamination testing at the start and end of each treatment cycle (or discontinuation visit if the participant withdrew). No assessments were required from the T-326 inhaler when participants started the treatment period (days 1 and 57). Microbial contamination was measured according to device type and the frequency of organism growth (light/ moderate/ heavy). All nebulisers (neb) used by the participants were analyzed, including those for inhaling other medications, like mucolytics.|days (d) 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with an available culture from the delivery device, were analyzed.|||Participants|||Number
1346738|NCT01844778|Secondary|Change in P. Aeruginosa Sputum Density|Sputum samples were sent to a central laboratory at the start and end of 2 treatment periods. The absolute change in the number of colony forming units (CFU) of Pseudomonas aeruginosa in sputum = the value of end of on/off treatment period of the cycle minus the pre-dose value at the start of that cycle. A negative change from baseline indicates improvement.|days 1, 28 (cycle 1); 57, 84, 112 (cycle 2)|"The FAS was considered and included participants who received at least 1 dose of treatment. Only participants (n), with values at the start and end of an on-treatment period (on-treatment change), and/or with values at the start of an on-treatment period and end of an off-treatment period (off-treatment change), were analyzed."|||log10 CFU/mL||Standard Deviation|Mean
1346739|NCT01844778|Primary|Mean Total Administration Time|The mean total time for administration of TIP via T-326 inhaler versus the total time for administration of COLI or TIS was assessed from information entered by participants into an ediary during the last 7 days prior to the last dose of a cycle. The total time included the setup, preparation, administration and cleaning/disinfection time.|days 22 through 28 (cycle 1), days 78 through 84 (cycle 2)|The full analysis set (FAS) was considered for this analysis. The FAS included participants who received at least 1 dose of treatment. Only participants (n), with non-missing mean total administration time of initial and second cycles, were analyzed.|||minutes||Standard Deviation|Mean
1346740|NCT01844765|Secondary|Rate of Major Cytogenetic Response (MCyR) and Confirmed Cytogenetic Response (CCyR) in Newly Diagnosed Ph+ CML and in Ph+ CML-AP Patients Resistant/Intolerant to Either Imatinib or Dasatinib|Rate of major cytogenetic response (MCyR) and confirmed cytogenetic response (CCyR) in Newly diagnosed Ph+ CML and in Ph+ CML-AP patients resistant/intolerant to either imatinib or dasatinib by designated timepoints|6, 12, 18, 24, 36, 48, 66 cycles||2021-10-31|10/2021||||
1346741|NCT01844765|Other Pre-specified|Long Term Effect on Nilotinib on Bone Metabolism|Alteration of bone biochemical markers, DEXA and X-Ray|up to 66 cycles||2021-10-31|10/2021||||
1346742|NCT01844765|Secondary|Acceptability of Study Drug Formulation|Questionnaire to capture patient assessment of palatability (very good to very bad) and acceptability of taking the medication (very easy to very hard to administration).|day1, day 28, early discontinuation or month 12||2021-10-31|10/2021||||
1346743|NCT01844765|Secondary|Long Term Effect of Nilotinib on Growth, Development and Maturation|Assessment of development (growth and sexual maturation) and thyroid function|up to 66 cycles||2021-10-31|10/2021||||
1346749|NCT01844765|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of first study drug intake to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of their last assessment for patients on study and date of last contact for patients in follow-up.|up to 66 cycles||2021-10-31|10/2021||||
1346750|NCT01844765|Secondary|Time to Disease Progression for Imatinib or Dasatinib Resistant or Intolerant CML-CP Patients|Time to disease progression is the time from the date of first study drug intake to the date of event defined as the first progression to AP or BC (from CP) or to BC (from AP) or the date of CML-related death occurring on treatment, whichever was earlier.|up to disease progression (assessed up to a minimum of 12 cycles after first dose of treatment (June 2016))|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Participants with disease progression|||Number
1346751|NCT01844765|Secondary|Time to Disease Progression for Newly Diagnosed Ph+ CML-CP|Time to disease progression is the time from the date of first study drug intake to the date of event defined as the first progression to AP or BC (from CP) or to BC (from AP) or the date of CML-related death occurring on treatment, whichever was earlier.|up to disease progression (assessed up to a minimum of 12 cycles after first dose of treatment (June 2016))|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Participants with disease progression|||Number
1346752|NCT01844765|Secondary|Cumulative Best BCR-ABL Ratio Categories for Newly Diagnosed Ph+ CML-CP by 6 and 12 Cycles|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL ratio by percentage: > 0.0032 to ≤ 0.01% is equal to a log reduction category of >= 4 to <4.5 -log reduction (MR4); BCR-ABL ratio by percentage: <=0.0032% is equal to a log reduction category of >= 4.5-log reduction (MMR4.5)|minimum of 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants|||Number
1346753|NCT01844765|Secondary|Cumulative Best BCR-ABL Ratio Categories for Resistant/Intolerant Ph+ CML in CP by 6 and 12 Cycles|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL ratio by percentage: > 0.0032 to ≤ 0.01% is equal to a log reduction category of >= 4 to <4.5 -log reduction (MR4); BCR-ABL ratio by percentage: <=0.0032% is equal to a log reduction category of >= 4.5-log reduction (MMR4.5)|minimum of 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants|||Number
1346754|NCT01844765|Secondary|Duration of First MMR Among Patients Who Were Resistant or Intolerant to Either Imatinib or Dasatinib Who Achieved MMR|Duration of MMR is defined as the time between the date of the first MMR and the date of confirmed loss of MMR (i.e. the earliest of confirmed loss of MMR, CML-related death or progression to AP or BC). Participants without loss of MMR were censored at the last molecular assessment date.|from MMR until confirmed loss of MMR (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 19 of the 33 Resistant/intolerant Ph+ CML-CP participants achieved MMR up to June 2016.|||Participants with confirmed loss of MMR|||Number
1346755|NCT01844765|Secondary|Time to First MMR Among Imatinib or Dasatinib Resistant or Intolerant CML-CP Patients Who Achieved MMR|Time from first study drug intake to first MMR amongst imatinib or dasatinib resistant or intolerant patients with CML-CP computed only for patients who achieved MMR.|From first dose of study treatment until MMR criteria are met (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 19 of the 33 resistant/intolerant Ph+ CML-CP participants achieved MMR up to June 2016.|||months||95% Confidence Interval|Median
1346756|NCT01844765|Secondary|MMR Rate by Time Points in Ph+ CML-CP Patients Resistant or Intolerant to Imatinib or Dasatinib|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR by a time point if the patient met the MMR criteria at least once at any time between first study drug intake and the time point visit included.|By 3, 6, 9 & 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1346757|NCT01844765|Secondary|Duration of First MMR Among Newly Diagnosed Patients Who Achieved MMR|Duration of MMR is defined as the time between the date of the first MMR and the date of confirmed loss of MMR (i.e. the earliest of confirmed loss of MMR, CML-related death or progression to AP or BC). Participants without loss of MMR were censored at the last molecular assessment date.|from MMR until confirmed loss of MMR (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 17 of the 25 newly diagnosed Ph+ CML-CP participants achieved MMR up to June 2016.|||Participants with confirmed loss of MMR|||Number
1346758|NCT01844765|Secondary|Time to First MMR Among Newly Diagnosed Ph+ CML-CP Patients Who Achieved MMR|Time to MMR is the time from first study drug intake to first major molecular response computed only for participants who achieved MMR.|From first dose of study treatment until MMR criteria are met (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 17 of the 25 newly diagnosed Ph+ CML-CP participants achieved MMR up to June 2016.|||Months||95% Confidence Interval|Median
1346759|NCT01844765|Secondary|MMR Rate by Time Points in Newly Diagnosed Ph+ CML-CP Patients|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR by a time point if the patient met the MMR criteria at least once at any time between first study drug intake and the time point visit included.|by 3, 6, 9 and 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1347149|NCT01838863|Other Pre-specified|Severe Adverse Events (SAE)|Number of participants with severe adverse events (SAE)|Hospital stay up to day 28||||Participants|||Count of Participants
1346760|NCT01844765|Secondary|CCyR Rate by Cycles 6 and 12 in Newly Diagnosed Ph+ CML-CP Patients|Cytogenetic response is assessed as the percentage of Philadelphia positive (Ph+) metaphases in the bone marrow. Complete Cytogenetic Response (CCyR) is defined as 0% of Ph+ metaphases. A patient was counted as having CCyR by 6 cycles (respectively 12 cycles) if the patient met the CCyR criteria at least once at any time between first study drug intake and cycle 6 (cycle 12 respectively) visit included.|6 & 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1346761|NCT01844765|Primary|Rate of Complete Cytogenic Response (CCyR) at 12 Cycles in Newly Diagnosed Ph+ CML-CP Patients|Cytogenetic response is assessed as the percentage of Philadelphia positive (Ph+) metaphases in the bone marrow. Complete Cytogenetic Response (CCyR) is defined as 0% of Ph+ metaphases. A patient was counted as CCyR at 12 cycles if the patient met the CCyR criteria at the Cycle 12 Visit.|12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1346762|NCT01844765|Primary|MMR Rate by 12 Cycles in Newly Diagnosed Ph+ CML-CP Patients|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR by 12 cycles if the patient met the MMR criteria at least once at any time between first study drug intake and Cycle 12 visit included.|12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1346763|NCT01844765|Primary|Rate of Major Molecular Response (MMR) at 6 Cycles for Ph+ CML CP Patients Resistant or Intolerant to Imatinib or Dasatinib|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR at 6 cycles if the patient met the MMR criteria at the Cycle 6 Visit.|6 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
1346764|NCT01844700|Secondary|BMI Percentile||baseline to week 12||||BMI percentile||Standard Deviation|Mean
1346765|NCT01844700|Secondary|BMI Z-scores||baseline to week 12||||BMI z-score||Standard Deviation|Mean
1346766|NCT01844700|Secondary|Percent Weight Change Compared to Baseline Weight||baseline to week 12||||percentage of weight change||Standard Deviation|Mean
1346767|NCT01844700|Primary|Weight Change||baseline to week 12||||lbs||Standard Deviation|Mean
1346768|NCT01844687|Other Pre-specified|Plasma Concentration of CBD|Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.|6 hours|8 participants volunteered to come to a ninth session for dosing with 800 mg CBD and donation of 7 blood samples.|||ng/mL||Standard Error|Mean
1346769|NCT01844687|Other Pre-specified|Heart Rate|Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.|120 minutes before and 150 minutes after marijuana cigarette smoking|all study completers|||beats per minute||Standard Error|Mean
1346770|NCT01844687|Other Pre-specified|Number of Optional Puffs of MJ Cigarette Taken|Mean number of puffs taken by those participants who chose to take additional puffs.|150 to 160 minutes after first marijuana cigarette was smoked earlier in the day|Those who took additional puffs of MJ cigarette.|||number of puffs taken per participant||Standard Error|Mean
1346771|NCT01844687|Other Pre-specified|Optional Additional Puffs of MJ Cigarette|Participants were allowed to choose to take or reject additional puffs of the same type of MJ cigarette they smoked earlier in the day. Counts of participants choosing to take additional puffs are reported.|150 to 250 minutes after first marijuana cigarette was smoked earlier in the day|all study completers|||Participants|||Count of Participants
1346772|NCT01844687|Other Pre-specified|Marijuana Rating Form - Strength|Subjects rated how strong the effects of the cannabis were using a visual analog scale.|15 - 120 minutes after marijuana cigarette smoking|all study completers|||units on a scale||Standard Error|Mean
1346773|NCT01844687|Other Pre-specified|Marijuana Rating Form - Like|Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most|15 - 120 minutes after marijuana cigarette smoking|all study completers|||units on a scale||Standard Error|Mean
1346774|NCT01844687|Primary|Mood Scale - Subscale 'Feeling High'|Visual analog scale range 1 (not at all) - 100 (extremely) millimeters.|two hours before and after marijuana cigarette smoking|all 31 completers|||units on a scale VAS 1-100 mm||Standard Error|Mean
1346775|NCT01844531|Secondary|AUC0-tz for Metformin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346776|NCT01844531|Primary|Cmax for Metformin|Cmax (maximum measured concentration of the analyte in plasma) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1346821|NCT01843972|Primary|Frequency of Subjects With Drug-related Adverse Events (Part I)|Frequency of subjects with drug-related Adverse Events (AEs) (Part I)|Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7|Treated Set (TS): all subjects who were documented to have taken at least 1 dose of study medication.|||Participants|||Number
1346777|NCT01844531|Primary|Cmax for Empagliflozin|Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1346778|NCT01844531|Secondary|AUC0-tz for Empagliflozin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1346779|NCT01844531|Primary|AUC0−∞ for Metformin|AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346780|NCT01844531|Primary|AUC0−∞ for Empagliflozin|AUC0−∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1346781|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Cumulative Period|Overall number of participants with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the ST or LTE period, elected not to enter the LTE period, or completed both ST and LTE periods.|Day 1 to 6 months following discontinuation of treatment, up to March 2015|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication|||participants|||Number
1346782|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Short Term Period|Overall number of participants with either a positive immunogenicity response for ‘CTLA4 and possibly Ig’ or ‘Ig and/or Junction Region’ relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the ST period or completed the ST study without continuing abatacept treatment.|Day 1 to 168 days after the last dose of study medication in the short-term period|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication|||participants|||Number
1346783|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.~The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose, up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
1346784|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
1346785|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.~The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
1349158|NCT01809262|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline and Visit 6|Safety set.|||mmol/L||Inter-Quartile Range|Geometric Mean
1346786|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
1346787|NCT01844518|Secondary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113 during a 4-month treatment period. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL).|Days 57, 85 and 113|All treated participants, ages 6 to 17, with PK-evaluable concentration data|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1346788|NCT01844518|Secondary|Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)|ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables [number of active joints, number of joints with limitation of motion (LOM), physician global assessment of disease activity, parent global assessment of patient overall well-being, functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ) and C-reactive protein (CRP)] and ≥30% worsening in not more than 1 of the remaining 6 JIA core set variables.|Day 113|All participants, ages 6 to 17|||percentage of participants||95% Confidence Interval|Number
1346789|NCT01844518|Primary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL.|Day 113|All treated participants, ages 6 to 17, with evaluable PK concentration data|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1346790|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
1346791|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
1346792|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
1346793|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
1346794|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
1346795|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. The mean score for all participants in an arm at a given week was subtracted from the mean score of the participants in that arm at baseline. Mean changes from baseline score is presented for all participants in an arm that remained on treatment and completed the EORTC-QLQ-C30 questionnaire at that time point.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
1346796|NCT01844505|Secondary|Overall Survival Based on PD-L1 Expression Level|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization until date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants with evaluable PD-L1 expression level at baseline|||months||95% Confidence Interval|Median
1346797|NCT01844505|Secondary|Progression-Free Survival Based on PD-L1 Expression Level|PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 >=5% or PD-L1 <5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.|From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)|All randomized participants with evaluable PD-L1 expression level at baseline|||months||95% Confidence Interval|Median
1346798|NCT01844505|Secondary|Objective Response Rate (ORR) Per Investigator Assessment|The ORR was defined as the number of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From randomization until date of disease progression or the date of subsequent anti-cancer therapy, whichever occurs first (Assessed up to February 2015, approximately 20 months)|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
1346799|NCT01844505|Secondary|Overall Survival (OS)|OS data is presented as it was in Primary Outcome Measure #2. The statistical analysis following this outcome measure (#6) reports on a secondary objective comparing OS between the Nivolumab and Nivolumab + Ipilimumab arms.|From randomization to date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants|||months||95% Confidence Interval|Median
1346800|NCT01844505|Secondary|Progression Free Survival (PFS)|PFS data is presented as it was in Primary Outcome Measure #1. The statistical analysis following this outcome measure (#5) reports on a secondary objective comparing PFS between the Nivolumab and Nivolumab + Ipilimumab arms.|From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)|All randomized participants|||months||95% Confidence Interval|Median
1346801|NCT01844505|Primary|Rate of Progression-Free Survival|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.|6, 12, and 24 months|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
1346802|NCT01844505|Primary|Rate of Overall Survival|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.|6, 12, and 24 months|All randomized participants|||Probability of survival at Time T||95% Confidence Interval|Number
1346803|NCT01844505|Primary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization to date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants|||months||95% Confidence Interval|Median
1346853|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 0.5|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346804|NCT01844505|Primary|Progression Free Survival (PFS)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Progression is defined, using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants who started anti-cancer therapy without prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.|From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)|All randomized participants|||months||95% Confidence Interval|Median
1346805|NCT01844479|Secondary|Gait Speed Variability Dual Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Dual task used a simultaneous mental task while walking.|Both footwear conditions up to thirty minutes||||percentage of gait||Standard Deviation|Mean
1346806|NCT01844479|Secondary|Gait Speed Variability Single Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Single task means walking without a simultaneous mental task.|both footwear conditions up to 30 minutes||||percentage of gait||Standard Deviation|Mean
1346807|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Dual Task|Mediolateral (side-to-side) center of mass displacement in deg2 (degrees squared) under dual task gait. Dual task used a simultaneous mental task while walking.|both footwear conditions up to 30 minutes||||deg2||Standard Deviation|Mean
1346808|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Single Task|Mediolateral (side-to-side) center of mass displacement with displacement in deg2 (degrees squared) under single task gait conditions. Single task means walking without a simultaneous mental task.|under each foot where condition up to 30 minutes||||deg2||Standard Deviation|Mean
1346809|NCT01844479|Secondary|Double Support Time Dual Task Gait Initiation|percentage of stride time spent in double support time during dual task conditions and during gait initiation. Double support time refers to the time spent with both feet on the ground. Dual task used a simultaneous mental task while walking.|during each foot where condition up to 30 minutes||||percentage of stride time||Standard Deviation|Mean
1346810|NCT01844479|Secondary|Double Support Time Single Task|percentage of stride time spent in double support time during gait initiation. Double support time refers to the time spent with both feet on the ground. Single task means walking without a simultaneous mental task.|during each foot where condition up to 30 minutes||||percentage of stride time||Standard Deviation|Mean
1346811|NCT01844479|Secondary|Stride Velocity - Dual Task|Stride velocity during steady state dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes||||m/s||Standard Deviation|Mean
1346812|NCT01844479|Secondary|Gait Initiation - Dual Task|The number of steps taken to reach steady state walking under dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes||||Number of steps||Standard Deviation|Mean
1346813|NCT01844479|Other Pre-specified|Sudomotor Function|Sudomotor function will be measured by electrical sweat conductance (ESC), as expressed in microSiemens (µS).|at baseline, this is a single visit study expected to last one hour||||µS||Standard Deviation|Mean
1346814|NCT01844479|Other Pre-specified|Stride Velocity - Single Task|Stride velocity steady state gait single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes||||meters/second||Standard Deviation|Mean
1346815|NCT01844479|Secondary|Gait Initation - Single Task|The number of steps taken to reach steady state walking under single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes||||Number of steps||Standard Deviation|Mean
1346816|NCT01844479|Primary|Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking|Plantar foot temperature changes in regions-of-interest in response to walking 200 steps will be measured in each footwear condition and compared to baseline.|baseline and after 200 steps in each condition, this is a single visit study expected to last one hour||||Absolute change in temperature degrees||Standard Deviation|Mean
1346817|NCT01844388|Other Pre-specified|Reason for Contact Lens Replacement|The reason the contact lens needed to be replaced was recorded for each eye. The following categories are reported: Scheduled Replacement, Discomfort, Lens Damage, Unacceptable Vision and Lens Lost. There may be multiple reasons for replacement of the contact lens for a single eye.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.|||eyes|Participants||Number
1346818|NCT01844388|Other Pre-specified|Average Daily Contact Wearing Time|The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.|||hours per day||Standard Deviation|Mean
1346819|NCT01844388|Primary|Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline|Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.|Baseline, Day 90|Intent-to-treat Population included all randomized participants.|||percentage of participants|||Number
1346820|NCT01844206|Primary|The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery|The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.|Up to 48 hours post-operatively|"Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero (0) for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank."||||||
1346822|NCT01843972|Secondary|Tmax (Part I)|"tmax (time from dosing to maximum measured concentration of BI 691751) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PKS|||h||Full Range|Median
1346823|NCT01843972|Secondary|t1/2 (Part I)|"t1/2 (terminal half-life of the analyte of BI 691751 in plasma) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Pharmacokinetic (PK) set (PKS) which includes all subjects of the treated set were were randomised to active treatment in the single rising dose part of bioavailability part, and had no important protocol violations relevant for the statistical evaluation of further PK parameters. Only subjects with calculable PK parameter were analysed.|||h||Geometric Coefficient of Variation|Geometric Mean
1346824|NCT01843972|Secondary|AUC0-tz|"AUC0-tz (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 up to the last quantifiable data point) (Part I and Part II)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h|PPS-DP for part I and PPS-BA for part II. Only subjects with calculable PK parameter were analysed.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1346825|NCT01843972|Secondary|AUC0-infinity (Part I)|"AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 extrapolated to infinity) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PPS-DP. Only subjects with calculable PK parameter were analysed.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1346826|NCT01843972|Secondary|Cmax (Part I)|"Cmax (maximum measured concentration of BI 691751 in plasma) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Per protocol set for evaluation of dose proportionality (PPS-DP): This subject set includes all subjects of the TS who were randomised to active treatment in the single rising dose part or BA part, and had no important PVs relevant for the statistical evaluation of dose proportionality. Only subjects with calculable PK parameter were analysed.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1346827|NCT01843972|Primary|Cmax (Part II)|Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration|PPS-BA. Only subjects with calculable PK parameter were analysed.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1346828|NCT01843972|Primary|AUC0-72h (Part II)|"AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II).~PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration|Per protocol set for evaluation of bioavailability (PPS-BA). Only subjects with calculable PK parameter were analysed.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1346829|NCT01843933|Primary|Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions|"Mild Events/Interventions:~Mild oxygen desaturation: Pulse oximetry < 93% on room air or <95% on oxygen~Hypopneic hypoventilation: ETCO2 values < 30mmHg for >30 seconds~Bradypneic hypoventilation: ETCO2 values > 50mmHg for >30 seconds~Stimulation: Verbally or physical stimulation to encourage breathing~Moderate Events/Interventions:~Moderate oxygen desaturation: Pulse oximetry < 85% on room air or <90% on oxygen~Apnea: ETCO2 value of 0mmHg or respiratory rate of 0 for >20 seconds~Airway obstruction: ETCO2 value of 0mmHg without cessation of respiratory effort~Airway repositioning: Jaw thrust or chin lift or use of a shoulder roll~Airway adjunct: Oral or nasal airway device~Severe Events/Interventions:~Severe oxygen desaturation: Pulse oximetry < 80% on room air or <85% on oxygen~Assisted ventilation: Use of a bag-valve mask, a laryngeal mask airway or endotracheal intubation~Reversal medications: Use of naloxone or flumazenil"|Post operative period (From entering the PACU until discharge. Average time is 1 hour)||||participants|||Number
1346830|NCT01843920|Secondary|Number of Participants With Return of Intraocular Pressure to Normal Levels|Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit|Month 2||||Participants|||Count of Participants
1346831|NCT01843920|Primary|Complete Resolution of Intraocular Gas Bubble|This will be reported by the patient when they see/feel the gas bubble disappear.|Following surgery, until gas bubble is gone. Up to 2 months.||||Duration in days, gas bubble||Full Range|Mean
1346832|NCT01843842|Secondary|Percentage of Patients With Exacerbation of the Disease Course|The development of disease complications requiring antibiotics administration or hospitalization|On days 1-6 of observation|Per Protocol set.|||percentage of participants|||Number
1346833|NCT01843842|Secondary|Number of Intakes of Antipyretics if Indicated|Based on data mentioned in a patient's diary|On day 1, 2, 3, 4 and 5 of the treatment|Per Protocol set.|||Number of intakes||Standard Deviation|Mean
1346834|NCT01843842|Secondary|"Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS)"|"The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom.~The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).~The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С).~Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5."|On days 1-6 of observation|Per Protocol set.|||AUC score*day||Standard Deviation|Mean
1346835|NCT01843842|Secondary|Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data|"Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).~The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5."|baseline and days 2, 3, 4 and 5 of observation|Per Protocol set.|||hours||Standard Deviation|Mean
1346836|NCT01843842|Secondary|Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)|"The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom.~The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).~The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С).~Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5."|on Days 2, 3, 4, 5 of Observation|Per Protocol set|||Score||Standard Deviation|Mean
1346837|NCT01843842|Secondary|Percentage of Patients With Normal Body Temperature (≤37.0ºС)|Axillary temperature (morning and evening) decline to or below 37.0 ºС|On day 2, 3, 4, 5 of observation|Per Protocol set.|||percentage of participants|||Number
1346838|NCT01843842|Secondary|Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)||baseline and days 2, 3, 4 and 5 of observation|Per Protocol set. The morning temperature in 13 patients (7 in the Ergoferon group and 6 in the placebo group) was excluded from the analysis due to mistakes in diaries.|||°C||Standard Deviation|Mean
1346839|NCT01843842|Primary|Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)|Based on the data mentioned in a patient's diary|On day 2, 3 and 4 of observation|Per Protocol set|||percentage of participants|||Number
1346854|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
1346855|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
1347150|NCT01838863|Other Pre-specified|Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI)|Number of participants with 28-day mortality. Traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck >=3.|Hospital stay up to 28 days.||||Participants|||Count of Participants
1346840|NCT01843777|Secondary|Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids|The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points.|Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention|In the standard-of-care group, one subject withdrew from the study prior to the collection of outcome measures. In the treatment group, one subject did not answer one of the questions on the baseline questionnaire, thereby preventing calculation of a total score. This subject's data is therefore not included in the analysis.|||units on a scale||Standard Deviation|Mean
1346841|NCT01843777|Primary|Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention|Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.|Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date|"Standard-of-care group: one subject withdrew prior to the collection of outcome measures and one subject did not give valid data log measurement. These subjects are not included.~Treatment: Three subjects did not give valid outcome data log measurement and one did not give a valid baseline measure. These subjects are not included."|||hours||Standard Deviation|Mean
1346842|NCT01843673|Primary|Greater Than or Equal to 5% Variation of Normal Tissue Toxicity||Up to 7 weeks|No data analyzed due to staff leaving primary institution.||||||
1346843|NCT01843673|Primary|Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%||Up to 7 weeks|No data analyzed due to staff leaving primary institution.||||||
1346844|NCT01843673|Primary|Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies|The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.|up to 7 weeks|Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.|||mm||Standard Deviation|Mean
1346845|NCT01843660|Secondary|Number of Participants With Overall Analgesic Satisfaction Score|Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346846|NCT01843660|Secondary|Number of Participants With Analgesic Satisfaction Score|Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346847|NCT01843660|Secondary|Number of Participants Who Required Additional Dosage Administration|Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.|Baseline up to Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346848|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 6|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346849|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 4|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346850|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 3|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346851|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 2|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346852|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 1|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
1346856|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
1346857|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
1346858|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
1346859|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
1346860|NCT01843465|Primary|Real-time Documentation of Pulmonary Vein Disconnection|"Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as yes or no, and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4."|atrial fibrillation cryoablation procedure|According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed.|||number of PVs disconnected in realtime|Participants||Number
1346861|NCT01843374|Secondary|Number of Participants With Positive Anti-drug Antibodies|The immunogenicity titer is reported for samples confirmed positive for the presence of anti tremelimumab antibodies.|Week 5|Safety population|||Participants|Participants||Number
1346862|NCT01843374|Secondary|Number of Participants Reporting Any Serious Adverse Events||Day 1 to 90 days post dose|Safety population|||Participants|Participants||Number
1346863|NCT01843374|Secondary|Number of Participants Reporting Any Adverse Event|Any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Day 1- 90 days post dose|Safety population|||Participants|Participants||Number
1346864|NCT01843374|Secondary|Durable Disease Control Rate by Treatment Arm|Durable disease control rate (DDCR) is defined as the percentage of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 6 months duration|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population|||Percentage|Participants|95% Confidence Interval|Number
1346865|NCT01843374|Secondary|Disease Control Rate by Treatment Arm|Disease control rate (DCR) is defined as the proportion of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 12 weeks duration|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population|||Percentage|Participants|95% Confidence Interval|Number
1346866|NCT01843374|Secondary|Duration of Response by Treatment Arm|Duration of response will be defined as the duration from the first documentation of complete response (CR), partial response (PR) to the first documented disease progression.|Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.|ITT|||Months|Participants|Full Range|Median
1346867|NCT01843374|Secondary|Overall Response Rate by Treatment Arm|Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.|Time from randomization to best response to treatment, assessed up to 3 years.|ITT population|||Percentage|Participants|95% Confidence Interval|Number
1346868|NCT01843374|Secondary|Progression-free Survival by Treatment Arm|Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population|||Months|Participants|95% Confidence Interval|Median
1346869|NCT01843374|Secondary|OS Rate at 18 Months by Treatment Arm|The percentage of patients still alive at 18 months|18 months|ITT population|||Percentage of Participants|Participants|95% Confidence Interval|Number
1346870|NCT01843374|Primary|Overall Survival (OS)|Overall survival (OS) by treatment arm|3 years.|ITT population|||Number of Participants|Participants||Number
1346871|NCT01843348|Secondary|Duration of Wound Healing|A wound will be considered healed if all the suture material and staples are removed and the wound is intact. Number of participants is based on all patients of the respective treatment group in the safety set, excluding patients with no answer (unknown).|Post transplant until individual reporting||||days||Standard Deviation|Mean
1346872|NCT01843348|Secondary|Percent of Participants With Wound Healing Complications During Study|Information collected to report wound healing process which included percentage of participants with complications, fluid collections detected and occurrence of lymphoceles|Post transplant until individual reporting||||Percent of participants|||Number
1346875|NCT01843348|Secondary|Percent of Participants With Delayed Graft Function and Slow Graft Function|Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function (SGF) was defined as a serum creatinine >3.0 mg/dL at Day 5 post-transplantation. Full analysis set|Post transplant to month 12|Full analysis set|||Percent of participants|||Number
1346876|NCT01843348|Secondary|Percentage of Participants With Treatment Failure Endpoints at Month 12|Treatment failure endpoints: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)|Month 12 post transplant||||Percentage of participants|||Number
1346877|NCT01843348|Secondary|Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant|Modification of Diet in Renal Disease (MDRD) = For men: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x (albumin0,318) For women: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x albumin0,318) x 0.762 with urea nitrogen = urea / 2.144. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set|||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
1346878|NCT01843348|Secondary|Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set|||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
1346879|NCT01843348|Secondary|Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant|Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method = GFR=141 x min(Scr/κ, 1)α x max(Scr/κ, 1)1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black] where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is 0.329 for females and 0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set|||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
1346880|NCT01843348|Secondary|Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12|Combined endpoint included: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)|Month 12 post transplant|Full analysis set includes all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1346881|NCT01843348|Primary|Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens|"To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula:~GFR = 6.7/Scr + BW/4 – Surea/2 – 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set"|One year post transplant|Protocol analysis set comprised of participants who received at least one dose of study drug without major protocol deviaitons|||mL/min per 1.73m²||Standard Deviation|Mean
1346882|NCT01843205|Secondary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||degrees Fahrenheit||Standard Error|Mean
1346883|NCT01843205|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||beats per minute||Standard Error|Mean
1346884|NCT01843205|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
1346885|NCT01843205|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
1346886|NCT01843205|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346887|NCT01843205|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346888|NCT01843205|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346889|NCT01843205|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346890|NCT01843205|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346891|NCT01843205|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346892|NCT01843205|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346893|NCT01843205|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346894|NCT01843205|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346895|NCT01843205|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346896|NCT01843205|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346897|NCT01843205|Secondary|"Peak Ratings of Nauseous on the Visual Analog Scale"|"Subjects rated their feelings of Nauseous on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346909|NCT01843192|Secondary|Number of Subjects With 1 Chest Tube Placed|All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants|||Number
1346898|NCT01843205|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346899|NCT01843205|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346900|NCT01843205|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346901|NCT01843205|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346902|NCT01843205|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346903|NCT01843205|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346904|NCT01843205|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346905|NCT01843205|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346906|NCT01843205|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 stimulant items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both bupsirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346907|NCT01843205|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both bupsirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
1346908|NCT01843205|Primary|Number of Methamphetamine Doses Self-Administered|The reinforcing effects of methamphetamine will be determined during placebo and buspirone treatment using a modified progressive ratio procedure in which subjects are offered the opportunity to earn previously sampled doses of methamphetamine. Each ratio completed on the task will earn 1/10th of the sampled dose.|One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission||||Number of Methamphetamine Doses||Standard Error|Mean
1346952|NCT01842633|Secondary|Time to the Use of Rescue Medication.|Time taken by the participants to use the rescue medication|Up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment|||Minutes||Standard Deviation|Mean
1346910|NCT01843192|Secondary|Occurrence of Intra-operative Leak Test|This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure. This analysis was further restricted to those subjects in whom an intra-operative leak test was actually performed, as it was not standard of care at all participating institutions.|||participants|||Number
1346911|NCT01843192|Secondary|Operative Time|Defined as the duration in hours from the first skin incision to the closure of the last incision|Day of surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||hours||Standard Deviation|Mean
1346912|NCT01843192|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||days||Standard Deviation|Mean
1346913|NCT01843192|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||milliliters||Standard Deviation|Mean
1346914|NCT01843192|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||days||Standard Deviation|Mean
1346915|NCT01843192|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
1346916|NCT01843192|Primary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
1346917|NCT01842958|Secondary|Subject Satisfaction|"Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain.~General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain)"|12 months post loading|Modified Intent-to-Treat population. Data was not available for 3 subjects in 3.3 mm implant arm and for 2 subjects in the 4.1 mm implant arm.|||units on a scale||Standard Deviation|Mean
1346918|NCT01842958|Secondary|Number of Participants With Adverse Events and Adverse Device Effects|"Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading. The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes possibly related, probably related and related)."|Duration of the study from surgical visit to the 12 months post-loading visit|Safety population. One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the safety population.|||Participants|||Count of Participants
1346919|NCT01842958|Secondary|Gingival Recession|"Soft tissue measurements include:~CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth~Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters."|6 months to 12 months post loading|Modified Intent-to-Treat population. Data was not available from 4 subjects in the 3.3 mm arm and 3 subjects in the 4.1 arm|||mm||Standard Deviation|Mean
1346920|NCT01842958|Secondary|Implant Survival Rate|Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)|7 days, 25 days, 6 months post loading, and 12 months post loading|modified Intent-to-Treat population|||Participants|||Count of Participants
1346921|NCT01842958|Secondary|Implant Success Rate|Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant)|25 days, 6 months post loading, and 12 months post loading|modified Intent-to-Treat population|||Participants|||Count of Participants
1346922|NCT01842958|Secondary|Additional Mean Crestal Bone Level Changes|Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post post implant placement, 6 months post loading, and 12 months post loading|Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading|modified Intent-to-Treat population|||mm||Standard Deviation|Mean
1346923|NCT01842958|Primary|Mean Crestal Bone Level Change|Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla.|Baseline (implant placement) and 12 months post loading|modified Intent-to-Treat population|||mm||Standard Deviation|Mean
1346924|NCT01842906|Secondary|Nocturnal Awakenings|Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|approximately 10 hours||||Number of events||Inter-Quartile Range|Median
1346925|NCT01842906|Secondary|Acute Mountain Sickness Severity|Severity of acute mountain sickness will be evaluated by the Lake Louise Criteria (0-15 point scale) with higher scores representing more severe symptoms. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|approximately 10 hours|Severity|||unit on a scale||Inter-Quartile Range|Median
1346926|NCT01842906|Secondary|Number of Nocturnal Desaturations|Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|Approximately 10 hours||||Number of events||Standard Deviation|Mean
1346927|NCT01842906|Primary|Incidence of Acute Mountain Sickness|Acute mountain sickness will be measured by Lake Louise Criteria and diagnosed as LLC > or = to 3 with presence of a headache. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|Approximately 10 hours||||Participants|||Count of Participants
1346928|NCT01842841|Secondary|Change From Baseline in Chemokine [C-C Motif] Ligand 18 (CCL18) Levels at Week 101|Plasma CCL18 concentrations were measured using a time-resolved fluorescence assay. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1346929|NCT01842841|Secondary|Number of Participants With Change From Baseline in Neurological Status at Week 103|Neurological status was considered normal or abnormal based on investigator’s discretion. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population. Number of participants analyzed signifies participants evaluable for this outcome.|||participants|||Number
1346930|NCT01842841|Secondary|Change From Baseline in Plasma Chitotriosidase Levels at Week 101|Plasma chitotriosidase activity levels were measured using an enzymatic assay with 4-methylumbelliferyl-deoxychitobiose as a substrate. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population. Number of participants analyzed signifies participants who were not deficient at baseline in chitotriosidase activity or who did not have a 24 base pair duplication in either copy of the chitotriosidase gene.|||nanomole/milliliter/hour (nmol/mL/h)||Standard Deviation|Mean
1346931|NCT01842841|Secondary|Change From Baseline in Skeletal Age at Week 103: Z-Score|Skeletal age was measured via radiography (X-ray) of the left hand and wrist by the method of Greulich and Pyle. The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there was <50% of participants had evaluable data.||||||
1346932|NCT01842841|Secondary|Change From Baseline in Growth Velocity at Week 101 : Height Z-Score|The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. World Health Organization 2007 growth reference data were used for Z-score calculation. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Data was not reported as there was <50% of participants had evaluable data.||||||
1346933|NCT01842841|Secondary|Change From Baseline in Bone Marrow Burden (BMB) Score at Week 103|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0-16 points. A higher BMB score signified more severe bone marrow involvement. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population.|||units on a scale||Standard Deviation|Mean
1346934|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: T-Score|BMD was measured by DXA for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized T-scores; normal values were used from databases from Hologic based on standard criteria. T-scores are the number of SDs above or below the average for a young adult at peak BMD. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were <50% of participants with evaluable data.||||||
1346935|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: Z Score|BMD was measured by dual energy x-ray absorptiometry (DXA) for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized Z-scores (matched for age and gender). Z-scores express the BMD as the number of standard deviations (SDs) above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if greater than (>) 50 percent (%) of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were lesser than (<) 50% of participants with evaluable data.||||||
1346936|NCT01842841|Secondary|Change From Baseline in Spleen Volume Normalized to Body Weight at Week 103|Spleen volume was measured using MRI. Spleen volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population|||Percentage of body weight||Standard Deviation|Mean
1346937|NCT01842841|Secondary|Change From Baseline in Liver Volume Normalized to Body Weight at Week 103|Liver volume was measured using magnetic resonance imaging (MRI). Liver volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population|||Percentage of body weight||Standard Deviation|Mean
1346938|NCT01842841|Secondary|Change From Baseline in Platelet Count at Week 101|Baseline was the modified baseline platelet count, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population|||*10^9 platelets per liter||Standard Deviation|Mean
1346939|NCT01842841|Secondary|Change From Baseline in Hemoglobin Concentration at Week 101|Baseline was the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population|||gram per deciliter (g/dL)||Standard Deviation|Mean
1346940|NCT01842841|Primary|Number of Participants With Positive Anti-Velaglucerase Alfa Antibodies|Serum samples were collected for all participants for determination of anti-velaglucerase alfa antibodies every 12 weeks.|From Week 65 until the end of study (Week 155)|Safety population.|||participants|||Number
1346941|NCT01842841|Primary|Number of Participants With Abnormal and Clinically Significant Laboratory Test Results|Laboratory test results were considered abnormal and clinically significant at the discretion of the investigator.|From Week 65 until the end of study (Week 155)|Safety population.|||participants|||Number
1346942|NCT01842841|Primary|Number of Participants Using Concomitant Medication||From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.|||participants|||Number
1346943|NCT01842841|Primary|Number of Participants With Drug-related Adverse Events (AEs), Infusion-related AEs, and Serious AEs (SAEs)|An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered related to investigational product. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An infusion-related AE was defined as an AE that started either during or within 12 hours after the start of the infusion and that was judged as possibly or probably related to investigational product.|From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.|||participants|||Number
1346944|NCT01842789|Secondary|Recovery Time|Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.|1 to 2 months|All subjects followed for 1 to 2 months post treatment.|||days||Full Range|Median
1346945|NCT01842789|Primary|Number of Minutes From Visualizing the Target to Reaching the Target|To measure difference in time to target with and without the use of TAG. This is a time and motion study, with time measured at each stage of the procedure. The most important subject variable to consider was number of fibroids targeted, which influenced overall procedure time.|Intraoperative|All participants undergoing treatment with Acessa (with or without targeting animation guidance).|||Minutes per fibroid treated||Full Range|Mean
1346946|NCT01842789|Primary|Physician Feedback Regarding TAG System Use During Surgery.|Physician preference testing is assessed by the completion of a questionnaire using a 5 point rating system ranging from “strongly agree” (a rating of 5) to “strongly disagree” (a rating of 1) regarding the use of the TAG system. The questions included are in regards to ease of targeting, ease of visualizing the target, the addition of specific features that enhance user interface and the overall set-up.|Physicians have up to 1 hour after the procedure to fill out the questionnaire|All subjects in whom TAG was used as an accessory system. This outcome measure was specific to this arm of the study only. Physicians provided feedback regarding use of the accessory system but did not provide feedback regarding the standard system without guidance. Physicians rated the system on a scale of 1 Strongly disagree to 5 Strongly agree.|||units on a scale||Standard Deviation|Mean
1346947|NCT01842646|Secondary|Treatment Emergent Adverse Events|Treatment emergent adverse events occurring in equal to or more than 10% of participants.|2 years, 4 months|All participants|||Participants|||Count of Participants
1346948|NCT01842646|Secondary|Median Time to Transformation to Acute Myeloid Leukemia (AML)|To estimate the time to transformation to AML in patients with <20% blasts. In patients with less than 20% blasts, the time to transformation to AML will be defined as the date of the first dose of drug until either the percentage of bone marrow blasts or the percentage of peripheral blasts exceeds 20%, whichever is first.|Up to 2 years, 4 months||2018-09-30|09/2018||||
1346949|NCT01842646|Secondary|Median Event Free Survival|To estimate the event-free survival of patients of this population. Event-free survival will be defined as the date of the first dose of study drug until failure or death from any cause.|Up to 2 years, 4 months||2018-09-30|09/2018||||
1346950|NCT01842646|Secondary|Median Overall Survival (OS)|To estimate the overall survival of patients with refractory/relapsed myelodysplastic Syndrome (MDS) and chronic myelo-monocytic leukemia (CMML) treated with PF-0444913. Overall survival will be defined as the time period between the date of the first dose of drug until the time of death.|Up to 2 years, 4 months|All participants|||months||95% Confidence Interval|Median
1346951|NCT01842646|Primary|Overall International Working Group (IWG) 2006 Response Rate|Response recorded from the start of the treatment until disease progression/recurrence. All responses must last for at least 8 weeks. Complete Remission (CR): Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia will be noted, Peripheral blood: Hemoglobin ≥ 11 g/dL, Platelets ≥ 100 x 10^9/L, Neutrophils ≥ 1.0 x 10^9/L, Blasts 0% ; Partial Remission (PR): All CR criteria if abnormal before treatment, except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%, Cellularity and morphology not relevant; Marrow CR or Hematological Improvement (HI): Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Peripheral blood: if HI responses, they will be noted in addition to marrow CR. Further investigation of PF-04449913 would not be warranted if it produced an overall response rate (CR + PR + marrow CR+HI) of 10% or less (p0), and would be warranted if it produced an overall response rate of 30% or more (p1).|Up to 2 years, 4 months|All participants|||Participants|||Count of Participants
1351308|NCT01780870|Primary|The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks||||HOMA score||Standard Deviation|Mean
1346953|NCT01842633|Secondary|Number of Pain Free Participants|Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.|1 hour and 2 hour post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
1346954|NCT01842633|Secondary|Headache Relief|The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.|At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1346955|NCT01842633|Secondary|Change From Baseline in Headache Pain Intensity|Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).|At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1346956|NCT01842633|Secondary|Rate of Rescue Medication|Number of participants that took rescue medication over the total number of participants for a given treatment group|4 hours|ITT population defined as all participants who received treatment, who took rescue medication and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
1346957|NCT01842633|Secondary|Global Evaluation of Response to Treatment|Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral [neither poor nor good], 3-good, or 4-very good).|4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1346958|NCT01842633|Secondary|Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)|SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.|From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1346959|NCT01842633|Secondary|Total Pain Relief (TOTPAR)|TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.|From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1346960|NCT01842633|Secondary|Time to Meaningful Headache Relief|Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.|Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||min.||Full Range|Median
1346961|NCT01842633|Secondary|Number of Participants With Meaningful Pain Relief||Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
1346962|NCT01842633|Secondary|Time to Perceptible Headache Relief|Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.|Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||minutes (min.)||Full Range|Median
1346963|NCT01842633|Secondary|Number of Participants With Perceptible Pain Relief||Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
1346964|NCT01842633|Secondary|Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours|"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.~The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)."|From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1346983|NCT01842607|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline and up to Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Milliliters (mL)||Standard Deviation|Mean
1346965|NCT01842633|Primary|Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours|"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)."|Up to 4 hours post dose|Intention-to-treat (ITT) population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1346966|NCT01842620|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) Over Period|Time to reach maximum plasma concentration is the time at which Cmax of metformin was obtained for test and reference products.|From 0 to 36 h|PKP population|||h||Full Range|Median
1346967|NCT01842620|Secondary|Terminal Plasma Half-life (t1/2) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h|Terminal phase half-life is the time required for the study drug to reduce to 50% of its concentration. t1/2 of Metformin was determined for each participant, both for Test and Reference products.|From 0 to 36 h|PKP population|||h||Full Range|Median
1346968|NCT01842620|Secondary|The Elimination Constant (Kel) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h|The elimination constant (kel) of Metformin was analyzed for each participant, both for Test and Reference products. The calculations were based on the actual sampling times recorded during the study.|From 0 to 36 h|PKP population|||Per hour||Full Range|Median
1346969|NCT01842620|Primary|Geometric Means for Maximum Plasma Concentration of the Study Drug (Oxemet) to the Reference Drug (Glafornail) From 0 to 36 h|Cmax is maximum plasma concentration of metformin. Plasma concentration-time curve of metformin from time 0 to 36 h was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise data has been presented; however, the statistical analysis has been presented for overall period.|From 0 to 36 h|PKP population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1346970|NCT01842620|Primary|Geometric Means for Area Under Plasma Concentration Time Curve of the Study Drug (Oxemet) to the Reference Drug (Glafornail) Between Time Zero to Infinity (Inf) Over Period|Area under plasma concentration-time curve of metformin from time 0 to inf was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.|From 0 to 36 h|PKP population included all the participants who underwent plasma PK sampling and had evaluable area under curve assay results|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1346971|NCT01842620|Primary|Geometric Means of Area Under Plasma Concentration Time Curve of the Test Drug (Oxemet) to the Reference Drug (Glafornail) From Time Zero to the Time of Last Quantifiable Concentration of 36 Hours (h)|Area under plasma concentration-time curve of metformin was quantifiable from time 0 to 36 h. The parameter was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.|From 0 to 36 hours (h)|PK parameters [PKP] population included all the participants who underwent plasma PK sampling and had evaluable area under curve assay results.|||nanogram* h/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1346972|NCT01842607|Secondary|Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline|Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).|||Participants|||Number
1346973|NCT01842607|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline|Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).|||Participants|||Number
1346974|NCT01842607|Secondary|Change From Baseline in Pulse Rate Assessed at Week 52|Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Beats per minute (BPM)||Standard Deviation|Mean
1346975|NCT01842607|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1346976|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||participants|||Number
1346977|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
1346978|NCT01842607|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Milliseconds (msec)||Standard Deviation|Mean
1346979|NCT01842607|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, only participants with ECG results post-baseline were analyzed|||Participants|||Number
1346980|NCT01842607|Secondary|Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions|Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population|||Participants|||Number
1346981|NCT01842607|Secondary|Number of Participants Hospitalized Due to Exacerbations and Adverse Events|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population|||Participants|||Number
1346982|NCT01842607|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population.|||Participants|||Number
1346984|NCT01842607|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Score on scale||Standard Deviation|Mean
1346985|NCT01842607|Secondary|Annualized Rate of Exacerbations Per Year|Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose|AT Population|||Exacerbations per year||95% Confidence Interval|Mean
1346986|NCT01842607|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population. Only those participants available at the indicated timepoints were analyzed (represented by n=X in the category titles).|||Participants|||Number
1346987|NCT01842607|Primary|Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions|AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])|As Treated (AT) Population: all participants who received at least one dose of open label mepolizumab.|||Participants|||Number
1346988|NCT01842594|Secondary|The Toxicity|Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0.|2 Weeks||||participants|||Number
1346989|NCT01842594|Primary|The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan|A baseline whole-body [18F]-fluorodeoxyglucose(FDG) PET was performed before therapy initiation. Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. A second [18F]-FDG PET was performed after treatment completion. SUVs were calculated for all lesions. Regions of interest (ROI) were contoured to represent tumors (>2 cm) and organs (lungs, spleen, and liver) on all transaxial and coronal slices. ROIs were normalized for injection dose and body weight, and the maximum voxel value was recorded for each region or organ. The highest SUV measured with increased uptake was considered the SUVmax. Correlative diagnostic CT examinations were used for accurate localization of the lesions. The most intense uptake at baseline was identified as the index lesion and evaluated for treatment response.|2 Weeks||||percentage of the SUVmax Change|Participants|95% Confidence Interval|Mean
1346990|NCT01842464|Primary|Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure|Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.|one year|occurrence and severity of complication is recorded|||participants|||Number
1346991|NCT01842464|Primary|Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring|Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.|one year||||participants|||Number
1346992|NCT01842464|Primary|The Change With Distance Between the Vaginal Apex and the Introitus|The change with distance measured by centimeters, between the vaginal apex and the introitus|One year||||centimeters||Full Range|Mean
1346993|NCT01842438|Secondary|SCORE15 (Systemic Core Outcome Measure)|SCORE15 is an index of Family Function and Change, with 15 items. The potential range of scores is 15 to 75, with a lower score indicating higher family functioning. Total scores are reported in the data below.|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Data received at each time-point was T0: intervention 42, control: 43; T1: intervention 36, control 36; T2 (as above) intervention 28, control 32|||units on a scale||Standard Deviation|Mean
1346994|NCT01842438|Secondary|HADS (Hospital Anxiety and Depression Scale)|"The HADS has two scales: one anxiety and one depression. It is validated with population norms. Results are presented for T2 (6 month follow-up) and split by Patient, Partner and again by Intervention, Control.~Responses are scored on a scale of 0–3 (3 indicates higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0–7, mild 8–10, moderate 11–14, and severe 15–21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress."|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Data received at each time-point was T0: intervention, T1: immediately after intervention; T2 6months post intervention.|||units on a scale||Standard Deviation|Mean
1346995|NCT01842438|Primary|EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale|EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms. We used the sexual bother sub-scale as the primary outcome measure; score range 0-400. A higher score indicates better function/better outcome.|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Primary outcome was at T1, sample size at T1, n=21 intervention, n=22 control. Sample size at T2, n=13 intervention, n=14 control At T1 (immediate follow-up) 3 intervention patients had withdrawn and 4 control patients had withdrawn. The scale was completed only by patients (all of whom were men, by as study focused on prostate cancer).|||units on a scale||Standard Deviation|Mean
1346996|NCT01842334|Primary|Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients|Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.|During Week 10|Only the 5 completers of this study who made it to week 10 could have this measure analyzed.|||Cigarettes/day||Standard Deviation|Mean
1346997|NCT01841970|Secondary|Mean Pain Score Based on the Visual Analog Pain Scale|Mean pain score based on the Visual Analog pain scale. Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.|||units on a scale||Standard Deviation|Mean
1346998|NCT01841970|Secondary|Pain Recorded Yes or No on Visual Analog Scale (VAS)|Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.|||participants|||Number
1346999|NCT01841970|Secondary|Recurrence of Symptoms That Had Resolved With Treatment|Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.|||Participants|||Count of Participants
1347000|NCT01841970|Secondary|Incidence of Recurrence of Pre-procedure Symptoms|Recurrence of pre-procedure symptoms after initial improvement|Post treatment at Month 1, Month 3, and Month 6||||participants|||Number
1347001|NCT01841970|Primary|Number of Participants With Resolution of Symptoms|The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment|Post treatment at Month1, Month 3, Month 6|18 participants included. 2 participants were lost to follow up.|||participants|||Number
1347002|NCT01841931|Secondary|Positive Affect|The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).|6 months|Enrolled patients||||||
1347003|NCT01841931|Secondary|Quality of Life|Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.|6 months|Enrolled patients||||||
1347004|NCT01841931|Secondary|Psychiatric Distress|The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being.|6 months|Enrolled patients||||||
1347005|NCT01841931|Primary|Pain Severity|"Pain severity will be measured using a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine), adopted from the Brief Pain Inventory (BPI).~No results to report."|6 months|Enrolled patients||||||
1347006|NCT01841931|Primary|Opiate Withdrawal|Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction, and will remain withdrawal-free for the entire study duration.Assessed using Clinical Opiate Withdrawal Scale (COWS).|6 months|||||||
1347007|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percentage of participants|||Number
1347008|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percentage of participants|||Number
1347009|NCT01841697|Secondary|Change From Baseline in FPG at Week 24|Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1347010|NCT01841697|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 24 weeks|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.|||Percentage of participants|||Number
1347022|NCT01841606|Primary|Change in Cardiac Output From Baseline to 20 Minutes Post-spinal|Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)|Baseline and 20 minutes||||L/min||Standard Deviation|Mean
1347011|NCT01841697|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 27 weeks (including 3-week follow-up)|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.|||Percentage of participants|||Number
1347012|NCT01841697|Primary|Change From Baseline in A1C at Week 24|A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
1347013|NCT01841632|Secondary|Evaluation of Data From Routine Examinations Following Last Study Visit for Evidence of Long Term Safety From MultiStem Administration|The results of routine examinations, which are necessary for all transplant patients, will be used once a year and analyzed retrospectively.|up to six years|||||||
1347014|NCT01841632|Secondary|Evidence Confirming That MultiStem Does Not Promote Malignant Transformation or Tumor Growth|Four additional outpatient visits are planned to further evaluate the study patients (including screening for malignancies).|up to day 365 (+/-30)|A Per-protocol (PP) population consisting of all patients of the ITT population who showed no major protocol violations. Protocol violations that may have an impact on the study outcome were considered as major protocol violations.|||Participants|||Count of Participants
1347015|NCT01841632|Secondary|Time to First Biopsy-proven Acute Rejection|Per protocol biopsies will be performed on days 1, 4, 10. Additional biopsies will be taken whenever clinically necessary.|up to day 90 (+/-30)|||||||
1347016|NCT01841632|Primary|Infusional and Acute Toxicity, Using Toxicity Scoring Mechanism|"For the description of intraportal toxicity a doppler ultrasound examination will be performed to assess various parameters that describe velocity of flow and flow pattern.~For pulmonary toxicity the assessment begins with an arterial blood gas. If this reveals pathological findings, a chest X-ray is required for clinical reasons independent of the study enrolment. In addition, clinical data describing the need for postoperative re-intubation will be recorded and the patient is assessed for the occurrence of a pulmonary embolism according to clinical guidelines.~For systemic toxicity, the occurrence of anaphylactic shock due to standard clinical guidelines is recorded."|up to day 30 (+10)|A Per-protocol (PP) population consisting of all patients of the ITT population who showed no major protocol violations.|||Participants|||Count of Participants
1347017|NCT01841619|Primary|Skindex 29|The subjects also evaluated their skin-specific quality of life with the Skindex-29 − the questionnaire consisting of 29 items used to calculate three subscales: symptoms (pain, itch, burning, sensitivity), emotions (depression, anxiety, embarrassment, anger) and functioning (sleep, relationships with others). All assessments were repeated at all study visits. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
1347018|NCT01841619|Secondary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS)|"Disease activity will be measured using the CLASI activity score that describes the damage of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.~All patients were measured identically in all visits."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
1347019|NCT01841619|Primary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS)|"Disease activity will be measured using the CLASI activity score that describes the activity of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
1347020|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
1347021|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
1347027|NCT01841593|Primary|Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.|"To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration–time curve from 0–24 hours after dosing (AUC0–24h).~All pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0."|Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only))|Data from all enrolled participants who participated in at least two of the three PK assessments were included in the analysis.|||ng/mL||95% Confidence Interval|Geometric Mean
1347028|NCT01841567|Secondary|Overall Cost Regarding Dressing Wear Time||7 days|||||||
1347029|NCT01841567|Secondary|Pain Evaluation||7 days|||||||
1347030|NCT01841567|Secondary|Comfort, Comformability, Acceptability of the Dressing||7 days|||||||
1347031|NCT01841567|Secondary|Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.|The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery|7 days||||participants|||Number
1347032|NCT01841567|Primary|Minimize the Risk of the Development of Blistering.|Number of participants without blisters at study visit|7 days||||participants|||Number
1347033|NCT01841216|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard. The subject rated the intensity or resistance felt on each exercise on this scale. The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.|16 exercises during one 40 minute session||||units on a scale||Full Range|Mean
1347034|NCT01841216|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.|One 40 minute session||||percentage of MVIC of gmax||Standard Deviation|Mean
1347035|NCT01841021|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) to be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade.|Up to 24 months post treatment|All participants.|||Participants|||Count of Participants
1347036|NCT01841021|Secondary|Overall Survival (OS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Radiological assessments to be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival to be evaluated every 3 months until 2 years from the start of study treatment or until study closure.|24 months post treatment or until study closure|Participants evaluable at 24 months post treatment or at study closure.||||||
1347037|NCT01841021|Secondary|Progression Free Survival (PFS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Stable disease (SD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|24 months post treatment|Participants evaluable at 24 months post treatment.||||||
1347038|NCT01841021|Secondary|Time to Disease Progression (TTP)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Progressive disease (PD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|Up to 24 months post treatment|All participants.|||months|||Number
1347039|NCT01841021|Secondary|Duration of Response (DOR)|DOR: The number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1).|Up to 24 months post treatment|Participants with Complete Response or Partial Response.||||||
1347040|NCT01841021|Secondary|Time to Response (TTR)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. TTR: The time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Participants who did not have a confirmed response to be censored at the date of the last tumor assessment.|Up to 24 months post treatment|Participants with Complete Response or Partial Response.||||||
1347041|NCT01841021|Primary|Overall Response Rate (ORR)|ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.|Up to 24 months post treatment|All participants.|||Participants|||Count of Participants
1347042|NCT01840943|Secondary|Number of Participants With Adverse Events|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.|Up to 30 days after the last dose of study medication|Safety population included all randomized participants.|||participants|||Number
1347043|NCT01840943|Secondary|Apparent Volume of Distribution of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
1347044|NCT01840943|Secondary|Systemic Clearance of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
1347045|NCT01840943|Secondary|Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
1347046|NCT01840943|Secondary|Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
1347047|NCT01840943|Secondary|Area Under the Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
1347048|NCT01840943|Secondary|Time to Reach the Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
1347049|NCT01840943|Secondary|Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
1347050|NCT01840943|Secondary|Number of Participants With Overall Survival|Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause.|Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier|The mITT population included all randomized participants.|||participants|||Number
1347051|NCT01840943|Secondary|Health-related Quality of Life Assessment (HQL)|Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life.|Day 1 of each cycle of study medication and Week 4 after last dose of study medication|Data was not collected for this outcome measure as the study was early terminated.||||||
1347052|NCT01840943|Secondary|Duration of Response|It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause.|Up to 1 year of last dose (Week 24) administration|The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response.|||weeks||95% Confidence Interval|Median
1347053|NCT01840943|Secondary|Time to Response|It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements).|Up to Week 24|The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response.|||weeks||Full Range|Median
1347054|NCT01840943|Secondary|Number of Participants With Response|Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered.|Up to Week 24|The mITT population included all randomized participants.|||participants|||Number
1347055|NCT01840943|Secondary|Duration of Progression-free Survival|It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS.|1 year after the last dose (24 weeks) administration|The mITT population included all randomized participants.|||weeks||95% Confidence Interval|Median
1347056|NCT01840943|Primary|Number of Participants With Progression-free Survival Incidence at Week 24|Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Week 24|The modified intent-to-treat population included (mITT) included all randomized participants.|||participants|||Number
1347057|NCT01840605|Secondary|Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)|Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).|Week 2||||percentage of participants||95% Confidence Interval|Number
1347061|NCT01840410|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.|||Number of primary reasons|Participants||Number
1347062|NCT01840410|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.|||Paticipants|||Number
1347063|NCT01840410|Secondary|Number of Participants With Ranibizumab Treatments in Study Eye|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.|||Participants|||Number
1347064|NCT01840410|Secondary|Number of Participants With Requirement for Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at Month 1, were analyzed.|||Participants|||Number
1347065|NCT01840410|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||Participants|||Number
1347066|NCT01840410|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||Participants|||Number
1347067|NCT01840410|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.|Baseline (BL), Month 1 through Month 6, Month 1 through Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||letters||Standard Deviation|Mean
1347068|NCT01840410|Secondary|Number of Participants With Presence of Active Chorioretinal Leakage|The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).|Baseline, Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||Participants|||Number
1347069|NCT01840410|Secondary|Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline|Presence of subretinal fluid in study eye compared to baseline|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
1347070|NCT01840410|Secondary|Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
1347071|NCT01840410|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||microliter (ul)||Standard Deviation|Mean
1347072|NCT01840410|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||micrometer (um)||Standard Deviation|Mean
1347097|NCT01839708|Secondary|T3 Stress|Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.|3-month after the 16-week intervention||||units on a scale||Standard Deviation|Mean
1347073|NCT01840410|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||letters||Standard Error|Least Squares Mean
1347074|NCT01840410|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.|Baseline, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed.|||letters||Standard Error|Least Squares Mean
1347075|NCT01840345|Secondary|Stress|Stress will be measured by the Perceived Stress Scale ((PSS), a 10-item instrument for measuring the perception of stress, with total scores ranging from 0-40. Higher scores = higher perceived stress|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1347076|NCT01840345|Secondary|Mood|Mood will be assessed by using the Patient Health Questionnaire (PHQ-9), a validated 9-question assessment of depression with total scores ranging from 0-27. Higher score = worse depression.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1347077|NCT01840345|Secondary|Pain|Pain intensity will be measured by using the 100-point Visual Analogue Scale, a 100-mm horizontal line with anchors of “no pain at all” (at 0) and “worst pain imaginable” (at 100mm) on which patients’ pain intensities are measured.|Baseline, 4 weeks||||mm on 100 mm scale||Standard Deviation|Mean
1347078|NCT01840345|Primary|Opioid Use|The amount of opioid medication used was recorded. Then, it was converted to morphine equivalents (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf). Opioid use was measured over a 2-week baseline period. Then, the average opioid medication use/week was calculated. This was compared to the average opioid medication use/week after 4 weeks of NAC.|Baseline, 4 weeks||||morphine equivalent dose||Standard Deviation|Mean
1347079|NCT01840319|Primary|Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline|Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants’ data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.|30 days after last dose of Tigecycline (Day 108)|Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591).|||percentage of participants||95% Confidence Interval|Number
1347080|NCT01840163|Secondary|Patient Preparedness Decision Making for Systemic Treatment|Using a 12 item Decision preparedness scale, assessed the degree to which patients reported that the web intervention prepared them for making their systemic treatment decision.|9 months after enrollment||2018-09-30|09/2018||||
1347081|NCT01840163|Secondary|Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for.|Self reported knowledge about systemic treatment using a 5 item Breast Cancer Knowledge Measure (adapted).|9 months after enrollment||2018-09-30|09/2018||||
1347082|NCT01840163|Secondary|Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment|A 5 item subjective decision quality scale measured how satisfied patients were with their treatment decision. Patients were asked how well they agreed with 5 statements, with responses of ‘not at all’/’a little bit’/’somewhat’/’quite a bit’/’very much’. All responses were assigned values from 1 to 5, with higher values reflecting greater decision satisfaction. Two of the statements reflected satisfaction with the decision and were coded as 1 for ‘not at all’ through 5 for ‘very much’. The other three statements reflected dissatisfaction with the decision and were coded as 5 for ‘not at all’ through 1 for ‘very much’ The values of all 5 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (not at all) to 5 (very much). The subjective decision quality scale was modeled by linear mixed model to determine the effect of intervention on patient response.|4-5 weeks from date of enrollment||||units on a scale||Standard Deviation|Mean
1347083|NCT01840163|Secondary|Patient Deliberation for Locoregional Breast Cancer Treatment.|A 4 item Breast Cancer Treatment Deliberation Scale asked how deliberative patients were in making their treatment decision. The items asked how often they performed deliberative activities with answers of ‘not at all’/’a little’/’somewhat’/’quite a bit’/’a lot’. Each response was assigned a value of 1(‘not at all’) to 5(‘a lot), with a high value representing a greater amount of deliberation. The values of all 4 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (not at all) to 5 (a lot). The deliberation scale was then modeled using linear mixed models to determine the effect of the intervention on patient deliberation.|4-5 weeks from date of enrollment|participants|||units on a scale||Standard Deviation|Mean
1347098|NCT01839708|Secondary|T2 Stress|Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.|immediatly after the 16-week intervention||||units on a scale||Standard Deviation|Mean
1347084|NCT01840163|Secondary|Patient Preparedness Decision Making for Locoregional Treatment.|A 12 item decision preparedness scale asked whether the web intervention helped patients prepare for their treatment decision. Each item asked about a diefferent aspect of decision preparation, with responses of ‘not at all’/’a little’/’somewhat’/’quite a bit’/’a great deal’. Each response was assigned a value of 1(‘not at all’) to 5(‘a great deal’), with a high value representing a greater amount of preparedness. The values of all 12 items were combined using the arithmetic mean, to create a standardized scale ranging from 1(not at all) to 5 (a great deal). The decision making scale was modeled by linear mixed model to determine the effect intervention on patient preparation for decision making.|4-5 weeks from date of enrollment||||units on a scale||Standard Deviation|Mean
1347085|NCT01840163|Primary|Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant|Self reported values were evaluated using a 5 item question set adapted from Decision Quality Instrument. The questions determined patient desire for outcomes such as keeping their natural breast and avoiding radiation on a scale from 0 to 10. Patients were classified as values-concordant if their actual treatment aligned with their values score predicted treatment and otherwise were classified as non-concordant. The binary values-concordance variable was modeled as a function of intervention effect using both unadjusted and adjusted logistic mixed model regression.|4-5 weeks from date of enrollment||||Participants|||Count of Participants
1347086|NCT01840163|Primary|Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.|Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.|4-5 weeks from date of enrollment||||Participants|||Count of Participants
1347087|NCT01840072|Secondary|Quality of Life|Due to limited funding, quality of life data were not collected.|3 months|||||||
1347088|NCT01840072|Secondary|Cognitive Function (Montreal Cognitive Assessment)|Cognitive function was measured by Montreal Cognitive Assessment at 3 months after randomization. The MoCA is a 30-item test that evaluates the following seven cognitive domains: visuospatial/executive functions, naming, memory, attention, language, abstraction, and orientation. One point is added for participants with education <12 years. Scores on the MoCA range from 0 to 30 and cognitive impairment was defined as a score of <26.|Three months|In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.|||MoCA score||Inter-Quartile Range|Median
1347089|NCT01840072|Secondary|Cognitive Function (the Mini-Mental State Examination)|Cognitive function was measured by the Mini-Mental State Examination at 3 months after randomization. The MMSE contains 20 items that test cognitive performance in domains including orientation, registration, attention and calculation, recall, language, and visual construction. MMSE scores were divided into three ordinal categories: 24–30 (no cognitive impairment), 19–23 (mild cognitive impairment), and 0–17 (severe cognitive impairment).|Three months|In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.|||MMSE score||Inter-Quartile Range|Median
1347090|NCT01840072|Secondary|Long-term Neurological and Functional Status|Those patients who were still alive at hospital discharge were contacted by telephone to set up a follow-up clinical visit. Neurological function was assessed by the modified Rankin scale at the 3-month post-treatment follow-up visit. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death. Major disability was defined as a score of 3 to 5 on the modified Rankin Scale.|Three months|Those patients who are still alive and followed at 3-Month posttreatment follow-up visit|||Score on modified Rankin scale||Inter-Quartile Range|Median
1347091|NCT01840072|Secondary|Other Vascular Events|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of vascular events, such as myocardial infarction, will be collected.|3 months||||participants|||Number
1347092|NCT01840072|Secondary|Recurrent Stroke|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent stroke will be collected.|3 months||||participants|||Number
1347093|NCT01840072|Secondary|Mortality|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information on clinical deaths will be obtained.|3 months|All participants followed at 3-month posttreatment follow-up visit|||participants|||Number
1347094|NCT01840072|Secondary|A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.|Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 3 months after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death|3 months|All participants examined at 3-month posttreatment follow-up visit|||Participants|||Count of Participants
1347095|NCT01840072|Primary|A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.|Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 14 days after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death.|2 weeks||||participants|||Number
1347096|NCT01839708|Secondary|Measured Body Weight|measured body weight in person at WIC office|Immediatly after the 16-week intervention (T2)||||lbs||Standard Deviation|Mean
1347202|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 12 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 12 compared to Month 9|9 Months and 12 months||||Participants|||Count of Participants
1347099|NCT01839708|Secondary|T3 Physical Activity|Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.|3-month after the 16-week intervention||||Hours||Standard Deviation|Mean
1347100|NCT01839708|Secondary|T2 Physical Activity|Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.|immediatly after the 16-week intervention||||Hours||Standard Deviation|Mean
1347101|NCT01839708|Secondary|T3 Fruit and Vegetable Intake|self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.|3-month after the 16-week intervention||||units on a scale||Standard Deviation|Mean
1347102|NCT01839708|Secondary|T2 Fruit and Vegetable Intake|self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.|immediately after the 16-week intervention||||units on a scale||Standard Deviation|Mean
1347103|NCT01839708|Secondary|T3 Fat Intake|self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.|3-month after the 16-week intervention||||units on a scale||Standard Deviation|Mean
1347104|NCT01839708|Secondary|T2 Fat Intake|self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.|immediately after the 16-week intervention||||units on a scale||Standard Deviation|Mean
1347105|NCT01839708|Secondary|T1 Stress|Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.|baseline||||units on a scale||Standard Deviation|Mean
1347106|NCT01839708|Secondary|T1 Physical Activity|Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.|baseline||||hours||Standard Deviation|Mean
1347107|NCT01839708|Secondary|T1 Fruit and Vegetable Intake|self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.|baseline||||units on a scale||Standard Deviation|Mean
1347108|NCT01839708|Secondary|T1 Fat Intake|self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.|baseline||||units on a scale||Standard Deviation|Mean
1347109|NCT01839708|Primary|Measured Body Weight|measured body weight in person at WIC office|3 months after the 16-week intervention (T3)|The inconsistent number of participants that were reported because we conducted general linear mixed model for repeated measures, which is a partial intention-to-treat analysis (ITT), adjusting baseline assessment. We chose to perform this method without any ad hoc imputation as our approach to ITT because the overall high dropout was high|||lbs||Standard Error|Mean
1347110|NCT01839695|Primary|Primary Effectiveness Observation|Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.|1 month|Based on the number of ITT subject with evaluable data, subjects were considered unevaluable for treatment success if the 30 day imaging was unable to assess patency of the MSG and BSG. One subject completed CT imaging at discharge, which was not repeated at the 30 day visit, and, therefore, was not considered evaluable for this assessment.|||participants|||Number
1347111|NCT01839695|Primary|Primary Safety Observation - Rate of Major Adverse Events (MAEs)|Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.|1 month|Includes active subjects in the ITT population at 30 days post-index procedure.|||participants|||Number
1347146|NCT01838863|Other Pre-specified|Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock|Time to Admission and First Blood Transfusion in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||minutes||Inter-Quartile Range|Median
1347112|NCT01839604|Secondary|Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Tmax, Using the Plasma Concentration Data.|8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1.|8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day 1 of Cycle 1.|PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK|||h||Full Range|Median
1347113|NCT01839604|Secondary|Preliminary Assessment of the Anti-tumour Activity of AZD9150 by Evaluation of Tumour Response.|Tumour response assessment by modified Response Evaluation Criteria in Solid Tumours (RECIST). Overall tumour response: assessed by mRECIST for HCC overall visit response of CR (disappearance of baseline TLs and NTLs), PR (>=30% decrease in sum of TLs), SD (neither PR nor PD), PD (sum TLs increased >20%), or NE .|Every 6 weeks, assessed up to 12 months.|Evaluable for response: Dosed patients with measurable disease at baseline|||participants with Partial Response|||Number
1347114|NCT01839604|Secondary|Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data.|8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. From the multiple samples a timecourse is obtained of treatment conc in the plasma over time. From this curve the associated PK parameters e.g. Cmax are obtained. For n patients we obtain up to n parameters which can then be averaged.|8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day1 of Cycle1.|PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347115|NCT01839604|Primary|Number of Participants With Dose Limiting Toxicities During Cycle 1|Cycle 1 was defined as 3 loading doses given on Days 1, 3, and 5 followed by 3 weekly doses given on Days 8, 15, and 22.|DLT assessment window - Cycle 1 (22 days)|Safety: All patients who received at least 1 dose of AZD9150|||participants with DLT|||Number
1347116|NCT01839396|Secondary|Secondary Endpoints|"Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization.~Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state."|From baseline to 12 weeks post-randomization||||units on a scale||Standard Deviation|Mean
1347117|NCT01839396|Primary|Change in ON Time as Measured by Parkinson's Disease Diary|Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement|From baseline to 12 weeks post-randomization||||hours||Standard Deviation|Mean
1347118|NCT01839318|Secondary|Total Wettability Score|The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.|||units on a scale||Standard Deviation|Mean
1347119|NCT01839318|Primary|Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.|||seconds||Standard Deviation|Mean
1347120|NCT01839279|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCt) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1347121|NCT01839279|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment|||hour||Full Range|Median
1347122|NCT01839279|Secondary|Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347123|NCT01839279|Secondary|Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling|The relationship will be quantified using a linear mixed effects model with an intercept. Data from Day 5 and Day 14 were fitted into regression model to obtain a slope of change. The measure type 'Number' followed by (90% Confidence Interval) shown in results is the slope from the linear fit.|Day 5, Day 14|Pk/QTc Analysis set will include all subjects in the QT/QTc analysis set with at least one valid PK assessment. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.|||msec per ng/mL||90% Confidence Interval|Number
1347124|NCT01839279|Secondary|The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 5 (Tizanidine 8 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 5|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.|||msec||90% Confidence Interval|Least Squares Mean
1351309|NCT01780870|Primary|The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks||||μU/ml||Standard Deviation|Mean
1347125|NCT01839279|Primary|The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 14 (Tizanidine 24 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 14|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.|||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
1347126|NCT01839058|Secondary|Correlation Between Symptom Onset and Esophageal Shortening|Esophageal shortening will be defined as the point during the 20 minute acid infusion at which the lower esophageal sphincter begins to migrate proximally. A 2 minute window following this time point will then be used to determine if patients symptoms increased by > 2 on a visual analogue pain scale between 0 – 10.|20 minutes|||||||
1347127|NCT01839058|Secondary|Esophageal Length at Maximal Symptom Intensity|Mean length of esophagus at peak patient reported symptom intensity with acid infusion|20 minutes|||||||
1347128|NCT01839058|Secondary|Esophageal Length at Symptom Onset|Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms|20 minutes|||||||
1347129|NCT01839058|Primary|Mean Change in Esophageal Length With Acid|Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion|Length at T= 20 minutes - Baseline (T=0)||||centimeters||Standard Deviation|Mean
1347130|NCT01838980|Primary|Mean of All Subjects Colon Segments BBPS>=2|"Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon).~Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2."|Following the colonoscopic procedure- Up to 24 hours.|"15 subjects were enrolled to the study.~1 was excluded. Total of 14 subjects were analyzed."|||Mean of BBPS score per segment||Standard Deviation|Mean
1347131|NCT01838941|Secondary|Developmental Status|Denver Developmental Screening Test expressed in years and months.|6 months|The Denver Developmental Screening Test was not performed.||||||
1347132|NCT01838941|Primary|Peroxisome Biochemical Functions as Measured by Plasma Very Long Chain Fatty Acid|C26/C22 ratio in plasma is a recognized biomarker for very long chain fatty acid (normal range: 0.002-0.018). It was measured twice before the beginning of treatment and measured once at the end.|6 months||||ratio||Full Range|Mean
1347133|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot lysis 30 minutes after the maximal amplitude (MA) was finalized.|post-intervention and upon ED arrival||||percentage of clot lysed at 30 minutes||Inter-Quartile Range|Median
1347134|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot strength measures by G value in kilodynes per square centimetre (kdyn/cm^2).|post-intervention and upon ED arrival||||kdyn/cm^2||Inter-Quartile Range|Median
1347135|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) maximal amplitude (MA).|post-intervention and upon ED arrival||||millimeter (mm)||Inter-Quartile Range|Median
1347136|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) angle measured in degrees.|post-intervention and upon ED arrival||||degree||Inter-Quartile Range|Median
1347137|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Percentage of clot lysis 30 minutes after maximal amplitude (MA) value is finalized.|after injury and prior to hospital arrival, at about 15 minutes after injury||||percentage of clot lysed at 30 minutes||Inter-Quartile Range|Median
1347138|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).|after injury and prior to hospital arrival, at about 15 minutes after injury||||kdyn/cm^2||Inter-Quartile Range|Median
1347139|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) maximum amplitude (MA).|after injury and prior to hospital arrival, at about 15 minutes after injury||||millimeter (mm)||Inter-Quartile Range|Median
1347140|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) angle in degrees.|after injury and prior to hospital arrival, at about 15 minutes after injury||||degrees||Inter-Quartile Range|Median
1347141|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT) in seconds.|post-intervention and upon ED arrival||||second||Inter-Quartile Range|Median
1347142|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT).|after injury and prior to hospital arrival, at about 15 minutes after injury||||second||Inter-Quartile Range|Median
1347143|NCT01838863|Other Pre-specified|Time to Admission and First Blood Transfusion|Time to admission and first blood product transfusion in minutes.|Hospital stay up to 28 days.||||minutes||Inter-Quartile Range|Median
1347144|NCT01838863|Other Pre-specified|Number of Blood Products Transfused.|Number of blood products transfused in units.|Hospital stay up to 28 days.||||units||Inter-Quartile Range|Median
1347145|NCT01838863|Other Pre-specified|Haemoglobin (Hb) Level|Haemoglobin (Hb) level in g/dL units.|Hospital stay up to 28 days.||||g/dL||Inter-Quartile Range|Median
1347151|NCT01838863|Other Pre-specified|Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI)|Number of participants with mortality, adverse outcome-free days and transfusions in the patients with no severe traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck >=3.|Hospital stay up to 28 days.||||Participants|||Count of Participants
1347152|NCT01838863|Other Pre-specified|Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock|Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||days||Inter-Quartile Range|Median
1347153|NCT01838863|Other Pre-specified|Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock|Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.||||Participants|||Count of Participants
1347154|NCT01838863|Other Pre-specified|Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock|Time to Admission and First Blood Transfusion in minutes in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||minutes||Inter-Quartile Range|Median
1347155|NCT01838863|Other Pre-specified|Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock|Transfusions of blood products in units in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||units||Inter-Quartile Range|Median
1347156|NCT01838863|Other Pre-specified|Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock|Level of Haemoglobin (Hb) in g/dL in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||g/dL||Inter-Quartile Range|Median
1347157|NCT01838863|Other Pre-specified|Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock|Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||days||Inter-Quartile Range|Median
1347158|NCT01838863|Other Pre-specified|Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock|Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||Participants|||Count of Participants
1347159|NCT01838863|Other Pre-specified|Exploratory Analyses.|Adverse outcome free days|Hospital stay up to 28 days.||||days||Inter-Quartile Range|Median
1347160|NCT01838863|Other Pre-specified|Exploratory Analyses|Number of participants with 24-hour mortality, adverse outcome free days and transfusions|Hospital stay up to 28 days.||||Participants|||Count of Participants
1347161|NCT01838863|Other Pre-specified|Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level|defined as the first abnormal factor XIII (fibrin-stabilizing factor) level obtained upon ED arrival|within 30 minutes of Emergency Department (ED) arrival||||Participants|||Count of Participants
1347162|NCT01838863|Other Pre-specified|Admission (First Arrival) Coagulation Factor Levels|"defined as the first coagulation factor level obtained upon ED arrival~Coagulation Factor Reference Ranges~F2 F5 F7 F8 F9 F11~% % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0"|after injury prior to hospital arrival|Not all the timepoints are available for all the patients.|||percentage of activity||Inter-Quartile Range|Median
1347163|NCT01838863|Other Pre-specified|Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level|defined as abnormal coagulation factor XIII level obtained in the field prior to intervention|after injury prior to hospital arrival||||Participants|||Count of Participants
1347164|NCT01838863|Other Pre-specified|Baseline (Field) Coagulation Factor Levels|"defined as the first coagulation factor level obtained in the field prior to intervention~Coagulation Factor Reference Ranges~F2 F5 F7 F8 F9 F11~% % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0"|after injury and prior to hospital arrival, at about 15 minutes after injury||||percentage of activity||Inter-Quartile Range|Median
1347165|NCT01838863|Secondary|Number of Participants With Admission Severe Acidosis|Admission severe acidosis will be defined by base deficit (BD>10) upon ED arrival.|within 30 minutes of ED arrival||||Participants|||Count of Participants
1347166|NCT01838863|Secondary|Admission Acidosis|Admission acidosis will be defined by base deficit (BD) upon ED arrival.|within 30 minutes of ED arrival||||mEq/L||Inter-Quartile Range|Median
1347167|NCT01838863|Secondary|Number of Participants With Admission Severe Acidosis|Admission severe acidosis measured by lactate>5 upon ED arrival.|within 30 minutes of ED arrival||||Participants|||Count of Participants
1347168|NCT01838863|Secondary|Admission Acidosis|Admission acidosis measured by lactate upon ED arrival.|within 30 minutes of ED arrival||||mmol/L||Inter-Quartile Range|Median
1347169|NCT01838863|Secondary|Admission Clot Strength|Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).|within 30 minutes of ED arrival||||kdyne/cm^2||Inter-Quartile Range|Median
1347170|NCT01838863|Secondary|Number of Participants With Admission Severe Coagulopathy|Defined as international normalized ratio (INR) >1.3 obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83–1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|within 30 minutes of Emergency Department (ED) arrival||||Participants|||Count of Participants
1347171|NCT01838863|Secondary|Admission Coagulopathy|Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83–1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|within 30 minutes of Emergency Department (ED) arrival||||ratio||Inter-Quartile Range|Median
1347203|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 9 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 9 compared to Month 6|6 Months and 9 months||||Participants|||Count of Participants
1347172|NCT01838863|Secondary|Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence|The occurrence of in-hospital death or MOF within the first 28 days postinjury. MOF is defined using the validated Denver MOF score (Denver MOF score>3 of simultaneously obtained scores after 48 hours postinjury).|28 days||||Participants|||Count of Participants
1347173|NCT01838863|Primary|Number of Participants That Died Within 28 Days Post Injury|death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)|28 days||||Participants|||Count of Participants
1347174|NCT01838785|Secondary|The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.||two years|A subgroup of 5 subjects receive additional scan for a test/retest reliability study|||SUVR||80% Confidence Interval|Mean
1347175|NCT01838785|Primary|Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.||two years||||SUVR||95% Confidence Interval|Mean
1347176|NCT01838694|Primary|Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.||4 weeks|Analysis Population reflects participants for whom adequate analyzable samples were collected|||percentage change from baseline||Standard Deviation|Mean
1347177|NCT01838681|Secondary|Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period|The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
1347178|NCT01838681|Secondary|Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period|The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
1347179|NCT01838681|Secondary|Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period|The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
1347180|NCT01838681|Secondary|Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period|The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
1347181|NCT01838681|Secondary|Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period|The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
1347182|NCT01838681|Secondary|Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period|The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B|||units on a scale||Standard Error|Least Squares Mean
1347183|NCT01838681|Secondary|Remission at Week 24 in the Randomised Treatment Period|Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
1347184|NCT01838681|Secondary|Remission at Week 6 During the Randomised Treatment Period|Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
1347185|NCT01838681|Secondary|Response at Week 24 During the Randomised Treatment Period|Response is defined as a >=50% decrease from randomisation in MADRS total score.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
1347186|NCT01838681|Secondary|Response at Week 6 During the Randomised Treatment Period|Response is defined as a >=50% decrease from randomisation in MADRS total score.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
1347187|NCT01838681|Secondary|Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||Units on a scale||Standard Error|Least Squares Mean
1347188|NCT01838681|Secondary|Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
1347189|NCT01838681|Secondary|Full Remission Sustained During the Randomised Treatment Period|Full remission sustained is defined as having obtained full remission and remain in remission until completion of the study. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
1347190|NCT01838681|Secondary|Time to Full Remission During the Randomised Treatment Period|The time from randomisation until full remission has been obtained. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. The time to full remission was calculated using Kaplan-Meier Methods.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||Days||95% Confidence Interval|Median
1347191|NCT01838681|Secondary|Total Time in Remission During the Randomised Treatment Period|The total time the patient spends in remission during randomised treatment. Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score. Time in remission is defined as the sum of days over all periods between Period B visits where remission was obtained. The period between two visits is counted as in remission if the patient was in remission when the period started.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||Number of days||Standard Deviation|Mean
1347192|NCT01838681|Secondary|Full Global Score Remission During the Randomised Treatment Period|Full global score remission is defined as a Clinical Global Impression - Severity of Illness (CGI-S) score <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis, on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
1347193|NCT01838681|Secondary|Full Functional Remission During the Randomised Treatment Period|Full functional remission is defined as a Sheehan Disability Scale (SDS) total score <=6 and all SDS domain scores <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
1347194|NCT01838681|Primary|Full Remission During the Randomised Treatment Period|Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
1347195|NCT01838655|Other Pre-specified|Number of Participants Withdrawn From Investigational Product (IP) Due to Safety and Abnormal Laboratory Results||Study duration, up to 18 months||||participant withdrawals|||Number
1347196|NCT01838655|Other Pre-specified|Number of Adverse Events Related to Investigational Product (IP)||Study duration, up to 18 months||||adverse events related to IP|||Number
1347197|NCT01838655|Other Pre-specified|Severity of Adverse Events||Study duration, up to 18 months||||adverse events|||Number
1347198|NCT01838655|Other Pre-specified|Number of Non-ocular Adverse Events||Study duration, up to 18 months||||non-ocular adverse events|||Number
1347199|NCT01838655|Other Pre-specified|Number of Ocular Adverse Events||Study duration, up to 18 months||||ocular adverse events|||Number
1347200|NCT01838655|Secondary|Percent Change in Hair Melanin at 12 Months Compared to Baseline|Hair melanin was assessed using pyrrole-2,3,5-tricarboxylic acid (PTCA), a marker of eumelanin and 4-amino-3-hydroxyphenylalanine (4-AHP), a marker of pheomelanin.|Baseline and 12 months||||percentage change||Standard Deviation|Mean
1347201|NCT01838655|Secondary|Absolute Change in Hair Melanin at 12 Months Compared to Baseline|Hair melanin was assessed using pyrrole-2,3,5-tricarboxylic acid (PTCA), a marker of eumelanin and 4-amino-3-hydroxyphenylalanine (4-AHP), a marker of pheomelanin.|Baseline and 12 months||||ng/mg||Standard Deviation|Mean
1347206|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 12 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 12 compared to Month 9|9 Months and 12 months||||Participants|||Count of Participants
1347207|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 9 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 9 compared to Month 6|6 Months and 9 months||||Participants|||Count of Participants
1347208|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 6 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 6 compared to Month 3|3 Months and 6 months||||Participants|||Count of Participants
1347209|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 3 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 3 compared to previous visit.|Baseline and 3 months||||Participants|||Count of Participants
1347210|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 12 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 12 compared to Month 9|9 Months and 12 months||||Participants|||Count of Participants
1347211|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 9 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 9 compared to Month 6|6 Months and 9 months||||Participants|||Count of Participants
1347212|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 6 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 6 compared to Month 3|3 Months and 6 months||||Participants|||Count of Participants
1347213|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 3 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 3 compared to previous visit.|Baseline and 3 months||||Participants|||Count of Participants
1347214|NCT01838655|Secondary|Absolute Change in Electroretinogram (ERG) at Month 12 as Compared to Baseline.|Amplitude for the ERG parameter, Dark Adaptation (DA) Comb B, was measured at each visit. Participants left and right eye will be analyzed.|Baseline and 12 months|Right eyes (OD) and left eyes (OS)|||µV|eyes|Standard Deviation|Mean
1347215|NCT01838655|Secondary|Absolute Change in Electroretinogram (ERG) at Month 6 as Compared to Baseline.|Amplitude for the ERG parameter, Dark Adaptation (DA) Comb B, was measured at each visit. Participants left and right eye will be analyzed.|Baseline and 6 months|Right eyes (OD) and left eyes (OS)|||µV|eyes|Standard Deviation|Mean
1347216|NCT01838655|Secondary|Percent Change in Melanin Index at 12 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 12 Months||||Percentage change||Standard Deviation|Mean
1347217|NCT01838655|Secondary|Percent Change in Melanin Index at 9 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 9 Months|Participant 002 did not have skin reflectometry measurements for any site at Month 9.|||Percentage change||Standard Deviation|Mean
1347218|NCT01838655|Secondary|Percent Change in Melanin Index at 6 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Percentage change||Standard Deviation|Mean
1347219|NCT01838655|Secondary|Percent Change in Melanin Index at 3 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 3 Months||||Percentage change||Standard Deviation|Mean
1347220|NCT01838655|Secondary|Absolute Change in Melanin Index at 12 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 12 Months||||Melanin Index||Standard Deviation|Mean
1347221|NCT01838655|Secondary|Absolute Change in Melanin Index at 9 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 9 Months|Participant 002 did not have skin reflectometry measurements for any site at Month 9.|||Melanin Index||Standard Deviation|Mean
1347222|NCT01838655|Secondary|Absolute Change in Melanin Index at 6 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Melanin Index||Standard Deviation|Mean
1347223|NCT01838655|Secondary|Absolute Change in Melanin Index at 3 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 3 Months||||Melanin Index||Standard Deviation|Mean
1347224|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 12 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 12 Months||||Percentage change||Standard Deviation|Mean
1347225|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 9 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 9 Months|Participant 002 did not have skin reflectometry measurements for any site at Month 9.|||Percentage change||Standard Deviation|Mean
1347246|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 6 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 6 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
1347247|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 3 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 3 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
1351310|NCT01780870|Primary|The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks||||ng/ml||Standard Deviation|Mean
1347226|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 6 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Percentage change||Standard Deviation|Mean
1347227|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 3 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 3 Months||||Percentage change||Standard Deviation|Mean
1347228|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 12 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 12 Months||||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
1347229|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 9 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 9 Months|Participant 002 did not have any skin reflectometry measurements for any site at Month 9.|||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
1347230|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 6 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
1347231|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 3 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object’s reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 3 Months||||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
1347270|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline (Randomization Visit); End of Continuation Visit (Week 12)|Full Analysis Set (FAS). Last Observation carried Forward (LOCF). Number of participants taken into account for the analyses.|||hours||Standard Error|Least Squares Mean
1347232|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 12 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 12 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 12 months||||units||Standard Deviation|Mean
1347233|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 9 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 9 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 9 months||||units||Standard Deviation|Mean
1347234|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 6 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 6 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 6 months||||units||Standard Deviation|Mean
1347235|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 3 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 3 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 3 months||||units||Standard Deviation|Mean
1347236|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 12 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 12 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 12 months||||units||Standard Deviation|Mean
1347237|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 9 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 9 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 9 months||||units||Standard Deviation|Mean
1347271|NCT01838616|Secondary|Sleep Evaluation: Latency (Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS).|||hours||Standard Deviation|Mean
1351311|NCT01780584|Other Pre-specified|Postoperative Hospital Length of Stay||up to 3 month after surgery||||days||Full Range|Median
1347238|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 6 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 6 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 6 months||||units||Standard Deviation|Mean
1347239|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 3 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 3 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 3 months||||units||Standard Deviation|Mean
1347240|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 12 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 12 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 12 months||||units||Standard Deviation|Mean
1347241|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 9 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 9 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 9 months||||units||Standard Deviation|Mean
1347242|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 6 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 6 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 6 months||||units||Standard Deviation|Mean
1347243|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 3 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 3 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 3 months||||units||Standard Deviation|Mean
1347244|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 12 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 12 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
1347245|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 9 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 9 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
1347248|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 12 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 12 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 12 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
1347249|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 9 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 9 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 9 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
1347250|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 6 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 6 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 6 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
1347251|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 3 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 3 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 3 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
1347252|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 12 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 12 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 12 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347253|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 9 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 9 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 9 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347456|NCT01835899|Secondary|Cmax|Maximum measured concentration of BI 1015550 in plasma.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint and who did not have a protocol violation relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1347254|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 6 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 6 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 6 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347255|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 3 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 3 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 3 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347256|NCT01838655|Secondary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 9 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90” HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 9 months was calculated; these mean grades were then used to calculate absolute change from baseline at 9 months.|Baseline and 9 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347257|NCT01838655|Secondary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 6 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90” HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 6 months was calculated; these mean grades were then used to calculate absolute change from baseline at 6 months.|Baseline and 6 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347258|NCT01838655|Secondary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 3 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90” HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 3 months was calculated; these mean grades were then used to calculate absolute change from baseline at 3 months.|Baseline and 3 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347259|NCT01838655|Primary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 12 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90” HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 12 months was calculated; these mean grades were then used to calculate absolute change from baseline at 12 months.|Baseline and 12 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
1347260|NCT01838642|Secondary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of disease progression.|up to 6 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||months||Full Range|Mean
1347261|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Carcinoemybryonic Antigen (CEA) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal 0-2.5 mcg/L) following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CEA level relative to baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.||||||
1347262|NCT01838642|Secondary|Objective Response to Ponatinib|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 4 cycles of treatment with ponatinib|One participant died on study during cycle 2. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||participants|||Number
1347263|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Calcitonin (CTN) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal <10 pg/mL) following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CTN level relative to baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.||||||
1347264|NCT01838642|Secondary|Molecular Differences in Advanced Medullary Thyroid Cancer (MTC)|Compare the molecular profile of tumor deoxyribonucleic acid (DNA) prior to treatment with the molecular profile at the time of progression. Prior to the first dose of ponatinib and at time of progression, subjects were to undergo a biopsy of the primary tumor or any metastatic site for analysis of tumor DNA for rearranged during transfection (RET) or rat sarcoma (RAS) mutation. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% decrease in the sum of diameters of target lesions, taking as reference the smallest sum on study.|Prior to the first dose of ponatinib|Although molecular profiling was to be completed prior to first dose of ponatinib and at time of progression, samples were tested on arrival only as mutational status was an eligibility requirement. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||participants|||Number
1347265|NCT01838642|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|17 months and 19 days|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||participants|||Number
1347266|NCT01838642|Secondary|Progression Free Survival|Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||months||Full Range|Mean
1347267|NCT01838642|Primary|Overall Response Rate.|Defined as the percentage of participants with a best response (complete response (CR) + partial response (PR)) recorded from the start of the treatment until disease progression/recurrence assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||percentage of participants|||Number
1347268|NCT01838616|Secondary|Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest.~The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit); End of Week 3 (End of Titration Period)|Safety Set (SAF).|||number of events|||Number
1347269|NCT01838616|Secondary|Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest.~The composition score from participant who reported:~Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit) to End of Titration Period (End of Week 3)|Safety Set (SAF).|||participants|||Number
1347636|NCT01833403|Primary|Insulin Sensitivity|Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 150-180 minute interval of the clamp|1 month||||mg glucose /kg FFM/min||Standard Error|Mean
1347637|NCT01833403|Primary|Insulin Sensitivity||Baseline||||m value||Standard Deviation|Mean
1347272|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||hours||Standard Error|Least Squares Mean
1347273|NCT01838616|Secondary|Sleep Evaluation: Number of Hours Slept|"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||hours||Standard Deviation|Mean
1347274|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings|The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||number of awakenings||Standard Error|Least Squares Mean
1347275|NCT01838616|Secondary|Sleep Evaluation: Number of Awakenings|"The participants were requested to answer the following question:~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||number of awakenings||Standard Deviation|Mean
1347276|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||participants|||Number
1347277|NCT01838616|Secondary|Clinician Global Impression of Change at the End of Treatment|In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||participants|||Number
1347278|NCT01838616|Secondary|Patient Global Impression of Change at the End of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||participants|||Number
1347279|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
1347280|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347281|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
1348231|NCT01826370|Secondary|Change From Baseline to Week 24 of Fasting Blood Sugar|Change from baseline to week 24 of fasting blood sugar|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for fasting blood sugar.|||mg/dl||Standard Deviation|Mean
1347282|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347283|NCT01838616|Secondary|Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
1347284|NCT01838616|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347285|NCT01838616|Secondary|Changes in the Short Form Health Survey (SF-12) at the End of Treatment|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement since starting the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
1347286|NCT01838616|Secondary|Short Form Health Survey (SF-12)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347287|NCT01838616|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1347288|NCT01838616|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347313|NCT01838213|Primary|Treatment Failure|"Patients included in the study with urinary tract infection (UTI) and treated as part of normal routine were followed for 14 days and further prescriptions of antimicrobials normally used for treatment of UTI will be considered treatment failures. Only participants that received pivmecillinam are reported here. In the paper published in PlosOne High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli the mecillinam treatment group were compared with the group that did not receive mecillinam."|14 days after initiation of treatment|Patients that did receice pivmecillinam.|||Treatment success|||Number
1347289|NCT01838616|Secondary|Change in painDETECT Final Assessment at the End of Treatment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
1347290|NCT01838616|Secondary|painDETECT Final Assessment|The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being “negative” (had no neuropathic pain component). A value between 19 and 38 was rated as being “positive” (neuropathic component present). Values from 13 to 18 were scored as being “unclear”. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347291|NCT01838616|Secondary|Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”.~A negative change indicates that the pain intensity decreased from the start of the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
1347292|NCT01838616|Secondary|Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”"|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347293|NCT01838616|Secondary|Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
1347294|NCT01838616|Secondary|Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1347295|NCT01838616|Secondary|Change in Recalled Average Pain Intensity at the End of Treatment|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit).|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1347296|NCT01838616|Secondary|Recalled Average Pain Intensity|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1347314|NCT01838044|Secondary|Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Percentage of participants|||Number
1351312|NCT01780584|Other Pre-specified|Postoperative Length of Stay in Intensive Care Unit||up to 3 months after surgery||||hours||Full Range|Median
1347297|NCT01838616|Primary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS).|||units on a scale||Standard Error|Least Squares Mean
1347298|NCT01838616|Primary|Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)|"For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline Visit)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1347299|NCT01838590|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1347300|NCT01838590|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1347301|NCT01838590|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1347302|NCT01838590|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
1347303|NCT01838590|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1347304|NCT01838499|Secondary|Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain|"Assessment of change in pain via Numerical Rating Scale. Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale.~Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the average of the values collected in the 7 days prior to that visit."|12 weeks|FAS (LOCF)|||changes in scores on a scale||Standard Error|Least Squares Mean
1347305|NCT01838499|Secondary|"2) Subject’s Global Impression of Change Reported on PGIC Scale (1-7 Point Scale Ranging From 1 Very Much Improved to 7 Very Much Worse)"|"Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who are minimally improved, much improved or very much improved on the Patient's Global Impression of Change (PGIC)"|12 weeks||||% of patients|||Number
1347306|NCT01838499|Primary|1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks|Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12|12 weeks|FAS|||% of patients|||Number
1347307|NCT01838304|Secondary|Procedure Time|Time from endoscopic intubation until completion of the procedure. This is not really an outcome measure, but is used to assess balance between groups.|Procedure time (average of 9 minutes)||||minutes||Standard Deviation|Mean
1347308|NCT01838304|Secondary|Time Spent Below a Saturation of 80%|Number of seconds spent below saturation of 80%, reported as the total per group|Duration of sedation (mean 25 minutes)||||seconds|seconds||Count of Units
1347309|NCT01838304|Secondary|Decrease in Minute Ventilation From Baseline|Minute ventilation as determined by respiratory inductance plethysmography from initiation of sedation until emergence.|Duration of sedation (average of 25 minutes)||||percentage of baseline||97.5% Confidence Interval|Median
1347310|NCT01838304|Primary|Number of Participants Requiring Adjustment in Propofol Dosing|Following initial sedation, an infusion rate for propofol is determined by the CRNA (control) or software (experimental). If this rate is appropriate for the duration of the brief procedure, no adjustment to the rate will be required. A greater requirement for rate changes suggests that the anesthesia provider needs to be immediately available to perform these adjustments.|Intraprocedure (average of 9 minutes)||||Participants|||Count of Participants
1347311|NCT01838213|Other Pre-specified|Carriage of ESBL Producing Bacteria|Culture results from patient fecal samples will be collected up to 3 years after urinary tract infection and carriage of ESBL producing bacteria will be examined.|up to 3 years|||||||
1347312|NCT01838213|Secondary|Subjective Outcome|A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.|14 days|||||||
1347315|NCT01838044|Secondary|Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Percentage of participants|||Number
1347316|NCT01838044|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10|The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
1347317|NCT01838044|Secondary|Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its ’worst,’ ’least,’ ’average,’ and ’now’ (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
1347318|NCT01838044|Secondary|Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2|Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Period 1 and Period 2|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||% of days||Standard Deviation|Mean
1347319|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
1347320|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
1347321|NCT01838044|Secondary|Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|"The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents ‘does not interfere with sleep’ and 10 represents ‘completely interferes’ which means you are unable to sleep due to pain."|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Least Squares Mean
1347322|NCT01838044|Secondary|Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||percentage of participants|||Number
1347323|NCT01838044|Secondary|Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient’s overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
1347324|NCT01838044|Secondary|Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Percentage of participants|||Number
1347325|NCT01838044|Secondary|Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Baseline and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Least Squares Mean
1347326|NCT01838044|Secondary|Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Least Squares Mean
1347327|NCT01838044|Primary|Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms|The Daily Pain diary consists of an 11-point NRS ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.|Baseline and Week 5|The Full Analysis Set (FAS) that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Mean
1347328|NCT01837966|Primary|Anxiety Reduction|We hoped to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast. The Trait subscale (STAI-TRAID) of the Spielberger State-Trait Anxiety Inventory was administered before and after 10 minutes of aromatherapy treatment pre-surgery. The TRAIT subscale contains 20 questions scored on a Likert scale from 1-4; item scores are summed for a total score ranging from 20 to 80, with higher scores indicating higher anxiety. Change in anxiety was calculated as the score pre-aromatherapy minus the score post-aromatherapy. Higher positive change scores indicate greater reductions in anxiety.|20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)|Analysis of STAI-TRAIT questions|||units on a scale||Standard Deviation|Mean
1347329|NCT01837823|Secondary|MACE|Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 1 year.|at 1 year||||Participants|||Count of Participants
1347330|NCT01837823|Secondary|MACE|Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days.|at 30 days||||Participants|||Count of Participants
1347331|NCT01837823|Secondary|Correlation of Changes in Plaque Morphology|"Correlation of changes in plaque morphology by OCT, IVUS and NIRS with the perturbations in peripheral blood mononuclear cell transcriptome using microarray analysis.~data not collected for this measure."|baseline and at 8-12 weeks|||||||
1347332|NCT01837823|Secondary|Mechanism of Reverse Cholesterol Transport|To assess the mechanism of reverse cholesterol transport that arises with high-dose statin therapy, as related to changes in plaque lipid content and morphology, and systemic vascular inflammation. Reverse cholesterol transport (RCT) is a pathway by which accumulated cholesterol is transported from the vessel wall to the liver for excretion, thus preventing atherosclerosis.|baseline and at 8-12 weeks||||percentage of cholesterol||Standard Deviation|Mean
1347333|NCT01837823|Secondary|Plaque Morphology as Related to Haptoglobin|To relate changes in plaque lipid content and morphology to the patient haptoglobin genotype.|baseline and at 8-12 weeks|Only those participants with these genotypes were analyzed|||LCBI4mm max||Standard Deviation|Mean
1347334|NCT01837823|Secondary|Correlation of Baseline Lipid Parameters With Baseline LCBI4mm Max|Correlation of baseline lipid parameters with baseline LCBI4mm max|baseline||||Beta coefficient||95% Confidence Interval|Number
1347335|NCT01837823|Secondary|Biomarker Release|Post procedure CK-MB, Troponin-I release at final YELLOW lesion PCI.|within 24 hrs of PCI||||ng/ml||Standard Deviation|Mean
1347336|NCT01837823|Secondary|Change in Atheroma Volume|Change in total atheroma volume (TAV) and lumen cross sectional area on OCT.|baseline and at 8-12 weeks||||mm^3||Standard Deviation|Mean
1347337|NCT01837823|Secondary|LCBI 4mm at Same Anatomical Site|"As related to other outcomes, change in LCBI 4mm measured at the identical anatomical site at both time points, as defined by the LCBI4mm max site at baseline (rather than ΔLCBI4mm max).~LCBI4mm: 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow."|at baseline and at 8-12 weeks||||LCBI4mm max||Standard Deviation|Mean
1347338|NCT01837823|Secondary|Lesion LCBI|As related to other outcomes, change in LCBI measured across the entire lesion (rather than ΔLCBI4mm max). The LCBI Score, computed as the fraction of valid pixels within the scanned region that exceeded a LCP probability of 0.6 multiplied by 1000, summarized the amount of LCP in the entire scanned region of the coronary vessel on a 0-to-1000 scale .|at baseline and at 8-12 weeks||||LCBI4mm max||Inter-Quartile Range|Median
1347339|NCT01837823|Secondary|Inflammatory and Lipid Parameters|ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in inflammatory and lipid parameters responses to patient-derived samples.|baseline and at 8-12 weeks||||mg/dl||Standard Deviation|Mean
1347340|NCT01837823|Secondary|IVUS Imaging Measures|Correlation between ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in specific IVUS (ΔPlaque burden) imaging measures. Plaque burden is Plaque + Media divided by Total Plaque Area in %.|Baseline and 8 weeks||||percent of plaque burden||Standard Deviation|Mean
1347341|NCT01837823|Secondary|Fibrous Cap Thickness (FCT) by OCT|ΔFibrous Cap Thickness measured by OCT at baseline and at 8-12 weeks|baseline and at 8-12 weeks||||μm||Standard Deviation|Mean
1347342|NCT01837823|Secondary|Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max)|"Maximum LCBI 4mm (ΔLCBI4mm max) of the non-culprit YELLOW lesion at baseline and 8-12 weeks thereafter.~LCBI4mm max : 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow."|baseline and at 8-12 weeks||||LCBI4mm max||Standard Deviation|Mean
1347343|NCT01837823|Primary|Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP|Correlation between the change in plaque morphology composition by intravascular imaging with inflammatory cell activity.|baseline and 8-12 weeks||||beta coefficient||95% Confidence Interval|Number
1347344|NCT01837823|Primary|Correlation Between Plaque Morphology and HDL Functionality|Correlation between the changes in plaque morphology composition by intravascular imaging with changes in HDL functionality. HDL functionality is measured by the Cholesterol Efflux Capacity (CEC). Plaque morphology is represented by the Fibrous Cap Thickness.|baseline and 8-12 weeks||||beta coefficient||95% Confidence Interval|Number
1347345|NCT01837797|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.|From randomisation to end of treatment|15 patients were enrolled to Period 2, only 3 patients completed due to study termination|||participants|||Number
1347346|NCT01837797|Secondary|Sustained Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347347|NCT01837797|Secondary|Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347348|NCT01837797|Secondary|Sustained Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347349|NCT01837797|Secondary|Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347350|NCT01837797|Secondary|Change From Randomisation in Social Adaptation During the Randomised Treatment|Social Adaptation Self-evaluation Scale (SASS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347351|NCT01837797|Secondary|Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment|Sheehan Disability Scale (SDS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347352|NCT01837797|Secondary|Change From Randomisation in Clinical Global Impression During the Randomised Treatment|Clinical Global Impression - Severity of illness (CGI-S) score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347353|NCT01837797|Primary|Change From Randomisation in Depressive Symptoms During the Randomised Treatment|Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From randomisation to end of treatment|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients).||||||
1347354|NCT01837797|Secondary|Number of Adverse Events|15 patients were enrolled to Period 2; only 3 patients completed due to study termination|From randomisation to follow-up||||Adverse events|||Number
1347355|NCT01837719|Secondary|T-HALF of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Standard Deviation|Mean
1347356|NCT01837719|Secondary|Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis. n=evaluable participants|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1347357|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Full Range|Median
1347358|NCT01837719|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347359|NCT01837719|Secondary|Apparent Terminal Half-life (T-HALF) of Atazanavir|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Standard Deviation|Mean
1347360|NCT01837719|Secondary|Observed Concentration at 24 Hours (C24) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. C24 was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347361|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Full Range|Median
1347362|NCT01837719|Secondary|Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded at predose and 4 hours post dose at screening, Days -1, 1, 8 15, 22, 29 and study discharge. ECGs were recorded after the patient had been supine for at least 5 minutes. All ECG readings post dosing (including unscheduled) were included.|At screening; on Day -1; predose and 4 hours postdose on Days 1, 18, 15, 22, and 29; and at study discharge (Day 31)|All participants who received at least 1 dose of study medication and were evaluable.|||Participants|||Number
1347363|NCT01837719|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment; h=high; hpf=high power field. Abnormal criteria: Leukocytes, low (*10^3 c/uL): <0.85*preRx if preRx<LLN; <0.9*LLN if LLN≤preRx≤ULN;< 0.9*LLN if preRx=missing;<LLN if preRX>ULN. Neutrophils, low (*10^3 c/uL): <0.85*preRx if preRx<1.5; <1.5 if preRx=missing; <1.5 if preRx ≥1.5. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Blood, urine, h: ≥2*preRx if preRx≥1; ≥2 if preRx <1; ≥2 if preRx=missing. RBCs/WBCs, h (hpf): ≥2 if preRx=missing ≥2 if preRx<2 ≥4 if preRx ≥2. Creatine kinase, h (U/L): >1.5*preRx if preRx>ULN; >1.5*ULN if preRx≤ULN; >1.5*ULN if preRx=missing; AST, h (U/L): >1.25* preRx if preRx>ULN; >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing. Lactate dehydrogenase, h (U/L): >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing; >1.5*preRx if preRx>ULN.|At Screening and on Days -1,4, 11, 18, and 31 (study discharge)|All participants who received at least 1 dose of study drug and had laboratory test results available.|||Participants|||Number
1347364|NCT01837719|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs)|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant who receives an investigational product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is any untoward medical occurrence that at any dose results in death; is life-threatening; or requires or prolongs inpatient hospitalization.|On Day 24 or 31|All participants who received at least 1 dose of any study drug.|||Participants|||Number
1347365|NCT01837719|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1347453|NCT01835899|Secondary|Cmax,ss|Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1347366|NCT01837719|Primary|Maximum Observed Plasma Concentration (Cmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347367|NCT01837680|Secondary|Neonatal Hypoglycemia|Number of participants with incidence of blood sugar <40mg/dl in neonate|at birth, up to 41 weeks||||Participants|||Count of Participants
1347368|NCT01837680|Secondary|Polyhydramnios|Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected|at each visit in pregnancy up to 41 weeks|||||||
1347369|NCT01837680|Secondary|Shoulder Dystocia|Incidence of shoulder dystocia - data not collected|at birth, up to 41 weeks|||||||
1347370|NCT01837680|Secondary|Birth Rate|Number of live birth rate|at birth, up to 41 weeks||||Participants|||Count of Participants
1347371|NCT01837680|Secondary|Delivery Mode|method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected|at birth, up to 41 weeks|||||||
1347372|NCT01837680|Secondary|Intensive Care Admissions|Number of participants with incidence of neonatal intensive care unit admissions|at birth, up to 41 weeks||||Participants|||Count of Participants
1347373|NCT01837680|Secondary|Neonatal Bilirubin|Percentage of neonatal hyperbilirubinemia - data not collected|at birth, up to 41 weeks|||||||
1347374|NCT01837680|Secondary|Maternal Hypoglycemia|Number of participants with incidence of maternal hypoglycemia (<60mg/dl)|at delivery, up to 41 weeks||||Participants|||Count of Participants
1347375|NCT01837680|Secondary|Gestational Age at Delivery|Gestational age at delivery|at delivery, up to 41 weeks||||weeks||Inter-Quartile Range|Median
1347376|NCT01837680|Secondary|Neonatal Weight|Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight >90th percentile for gestational age|At delivery, up to 41 weeks||||g||Inter-Quartile Range|Median
1347377|NCT01837680|Secondary|Weight Gain|Total weight gain in pregnancy|Number of pounds gained at each visit up to 41 weeks||||lbs||Standard Deviation|Mean
1347378|NCT01837680|Secondary|Post-prandial Blood Glucose|Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits.|up to 41 weeks||||mg/dL||Standard Deviation|Mean
1347379|NCT01837680|Secondary|Average Fasting Glucose|Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits|up to 41 weeks||||mg/dL||Standard Deviation|Mean
1347380|NCT01837680|Secondary|Time to Achieve Glycemic Control|Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl|up to 41 weeks||||weeks||Full Range|Median
1347381|NCT01837680|Secondary|Number of Patients Obtaining Glycemic Control|Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl.|up to 41 weeks||||Participants|||Count of Participants
1347382|NCT01837680|Primary|Glycemic Control|Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits.|up to 41 weeks||||mg/dL||Standard Deviation|Mean
1347383|NCT01837550|Secondary|Communication Strategies Scale (CSS)|CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.|5 weeks, 6 months||||units on a scale||Standard Deviation|Mean
1347384|NCT01837550|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.|5 weeks, 6 months||||units on a scale||Standard Deviation|Mean
1347385|NCT01837550|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.|pre-measurement|The IOI-HA was used only at the pre-masurement point, to select descriptive data about the participants.|||units on a scale||Standard Deviation|Mean
1347386|NCT01837550|Primary|The Hearing Handicap Inventory for the Elderly (HHIE)|The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.|5 weeks, 6 months||||units on a scale||Standard Deviation|Mean
1347387|NCT01837537|Secondary|Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor|The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.|up to 40 minutes of continuous monitoring|90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)|||BrPM||Standard Deviation|Mean
1348309|NCT01824446|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 288 hours post-dose|PAS|||ng/ml||Standard Deviation|Mean
1347388|NCT01837537|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).|up to 40 minutes of continuous monitoring|90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)|||BrPM (breaths per minute)||Standard Deviation|Mean
1347389|NCT01837524|Other Pre-specified|Member Self-efficacy and Confidence in Food Purchasing Decisions|Will be assessed using a brief survey at baseline (scored) and re-surveyed after the intervention. Survey questions are based on similar items from other studies of health behavior interventions.|3 months|||||||
1347390|NCT01837524|Other Pre-specified|Cost of Grocery Shopping for Members|Receipts from a typical week's worth of grocery shopping will be collected from all participants at baseline. Then, the same process will be repeated each month during the intervention phase to see what effect participation has on costs of grocery shopping for participants (e.g. if buying more produce because shopping with dietitian - will shopping be more expensive?)|3 months|||||||
1347391|NCT01837524|Secondary|Nutritional Knowledge of Members|A modified version of the Parmenter-Wardle Nutrition Knowledge Questionnaire (1999, UK) has been created based on present-day guidelines and eating patterns in the Southeast U.S., and will be administered at baseline and scored, then re-administered after the intervention and re-scored to determine whether or how the score improved after the intervention with the dietitian.|3 months|||||||
1347392|NCT01837524|Primary|Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).|"The Block FFQ will be administered at baseline in order to calculate a participant's baseline HEI score, and will be re-administered after the 3 month intervention to re-calculate the post-intervention HEI score.~The numbers reported here represent the change from pre to post intervention, in the HEI scores for participants in each group~HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet. There are no units associated with the HEI score. The measure was developed by the US Dept of Agriculture and complete details regarding its development can be found on their website."|3 months||||points||Standard Deviation|Mean
1347393|NCT01836809|Secondary|Total Diuretic Requirement||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
1347394|NCT01836809|Secondary|Time to Renal Failure||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
1347395|NCT01836809|Secondary|Urine Output||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
1347396|NCT01836809|Secondary|Need for Hemodialysis/Renal Replacement Therapy||90 days|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
1347397|NCT01836809|Primary|Renal Plasma Flow||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
1347398|NCT01836809|Primary|Glomerular Filtration Rate||46 hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
1347399|NCT01836549|Secondary|Quantitative MRI Parameters of Tumors Prior to and After Treatment With Imetelstat (Molecular Biology and Phase II Studies)|This outcome measure was for both Molecular biology and Phase II studies. We will not be able to present the results of this objective as the study was terminated early.|Up to 30 days|This study has been terminated early and the study team decided not to pursue this aim as the results would be inconclusive due to small sample size. Neither the neuroimaging, nor the biology data are available for these patients.||||||
1347400|NCT01836549|Secondary|Number of Patients With Telomerase Expression Data by Detection of hTERT mRNA and TERC RNA Levels by qRT-PCR and Telomerase Activity by TRAP in Archival Tumor Tissue and to Explore Association of Telomerase Positivity With Objective Response and PFS|This secondary objective is for Stratum-B and C only, which enroll HGG and ependymoma patients. We will describe the evidence of telomerase expression by detection of hTERT mRNA and TERC RNA levels by qRT-PCR and telomerase activity by TRAP in archival tumor tissue; Association of telomerase positivity with objective response and PFS will not be able to be conducted as the study was terminated early and there was no objective response.|Up to 30 days. Due to small number of patients evaluable for this objective, we can only provide number of patients with the targetted markers as no analysis with PFS is possible.|This objective is for STRATUM-C patients only, having only 4 patients with TRAP, TERT and TERC levels measured. Due to small sample and having no objective response, association studies of these markers with Objective Reponse and PFS were not possible. Therefore, we only report the the percentage of cases with at least weak TRAP activity.|||Participants|||Count of Participants
1347401|NCT01836549|Secondary|Stratum-specific Progression-free Survival (PFS) (Phase II)|Kaplan-Meier estimates of distributions of survival and PFS for all eligible subjects who received at least one dose of imetelstat will be provided separately.|Up to 2 years, from the date of initial treatment to the earliest date of disease progression, second malignancy or death for subjects who fail; and to the date of last contact for subjects who remain at risk for failure, assessed up to 3 years|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|||days||Standard Error|Mean
1347402|NCT01836549|Secondary|Number of Participants With Telomerase Inhibition|This outcome measure is applicable only for the Molecular biology study arm. Telomerase inhibition was assessed in PBMCs and summarised as 'yes-inhibited' vs. 'no inhibition'|Up to 30 days|Samples from six patients were consequently considered evaluable and were analyzed.|||Participants|||Count of Participants
1347454|NCT01835899|Secondary|AUC0-infinity|Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1347403|NCT01836549|Primary|Phase II: Stratum-specific Objective Response (CR+PR) Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR sustained for at least 6 weeks.~For each stratum separately exact confidence interval estimates will be provided for the true, unknown rates of objective response. Estimated by cumulative incidence functions."|6 months|This is the Phase-II study cohort, excluding the molecular study patients.|||Participants|||Count of Participants
1347404|NCT01836549|Primary|Numver of Patients With Telomerase-positive Archival Tumors Who Demonstrate at Least 50% Reduction|This outcome measure is for the Molecular biology study only. The assessment was done to identify cases with at least 50% reduction in telomerase activity.|Up to 30 days|This outcome measure is only for the molecular biology study. Telomerase inhibition was assessed and the inhibition level was compared with the baseline level to identify increased inhibition.|||Participants|||Count of Participants
1347405|NCT01836523|Secondary|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes|This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.|Weeks 0-52|The safety analysis set included all randomised subjects exposed to at least one dose of liraglutide or placebo.|||episodes|||Number
1347406|NCT01836523|Primary|Change From Baseline in Total Daily Insulin Dose|Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline total insulin daily dose data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1347407|NCT01836523|Primary|Change From Baseline in Body Weight|Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline body weight data.|||kg||Standard Deviation|Mean
1347408|NCT01836523|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline HbA1c data.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1347409|NCT01836471|Secondary|Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set|ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = ‘totally controlled’ and 6 = ‘severely uncontrolled.’ Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.|baseline,12 weeks||||score||Standard Error|Least Squares Mean
1347410|NCT01836471|Secondary|Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set|ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = ‘totally controlled’ and 6 = ‘severely uncontrolled.’ Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.|baseline,12 weeks||||score||Standard Error|Least Squares Mean
1347411|NCT01836471|Secondary|Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.~Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).~Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks||||liter||Standard Error|Least Squares Mean
1347412|NCT01836471|Secondary|Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.~Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).~Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks||||liter||Standard Error|Least Squares Mean
1347413|NCT01836471|Primary|Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.~Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).~Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks||||liter||Standard Error|Least Squares Mean
1347414|NCT01836458|Secondary|Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42|PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 & Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).|Day 28, Day 35 & Day 42|Pharmacodynamic Analysis Set includes all enrolled patients.|||Percentage of Patients|||Number
1347415|NCT01836458|Secondary|Median Time to Fever Clearance|Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.|Day 1 to Day 5|Pharmacodynamic Analysis Set includes all enrolled patients|||hours||90% Confidence Interval|Median
1347416|NCT01836458|Secondary|Median Time to Parasite Clearance|Parasite clearance time will be estimated using thick/thin blood films.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609|Pharmacodynamic Analysis Set includes all enrolled patients|||hours||95% Confidence Interval|Median
1347417|NCT01836458|Primary|Minimum Inhibitory Concentration (MIC) of KAE609|To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.|Up to Day 8 after a single dose of KAE609|The primary Outcome Measure (OM) could not be determined due to small sample size no data was collected from any participants.||||||
1347418|NCT01836445|Other Pre-specified|Level of Privacy|Log of the levels of privacy of the locations where participants completed intervention.|Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)|Participants who reported information about the locations where they completed the intervention sessions.|||Participants|||Count of Participants
1347419|NCT01836445|Other Pre-specified|Occurrence of Sexually Transmitted Infections (STIs) at 6 Months|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.|6 Months|Participants who were positive for an STI at baseline, were sent a follow-up test kit at 6 Month Follow-up, and tested positive again.|||Participants|||Count of Participants
1347420|NCT01836445|Other Pre-specified|Occurrence of Sexually Transmitted Infections (STIs) at 3 Months|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.|3 Months|Participants who were positive for an STI at baseline, were sent a follow-up test kit at 3 Month Follow-up, and tested positive again.|||Participants|||Count of Participants
1347421|NCT01836445|Other Pre-specified|Participant Experiences of Harm at 12 Month Follow-up|Log of any negative experiences or harm experienced by participant at twelve months.|12 Months|Number of participants who reported negative health experiences at 12 Month Follow-up as a result of participating in the study|||Participants|||Count of Participants
1347422|NCT01836445|Other Pre-specified|Participant Experiences of Harm at 6 Month Follow-up|Log of any negative experiences or harm experienced by participant at six months.|6 Months|Number of participants who reported negative health experiences at 6 Month Follow-up|||Participants|||Count of Participants
1347423|NCT01836445|Other Pre-specified|Participant Experiences of Harm at 3 Month Follow-up|Log of any negative experiences or harm experienced by participant at three months.|3 Months|Number of participants who reported negative health experiences at 3 Month Follow-up|||Participants|||Count of Participants
1347424|NCT01836445|Other Pre-specified|Participant Location|Log of where participants completed the intervention sessions (participants can select multiple locations).|Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)|Participants who reported information about the locations where they completed the intervention sessions.|||Participants|||Count of Participants
1347425|NCT01836445|Other Pre-specified|Participant Rating of Intervention Acceptability and Tolerability|Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability.|Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)|Enrolled participants who completed assessments on intervention acceptability immediately following completion of intervention.|||units on a scale||Standard Deviation|Mean
1347426|NCT01836445|Secondary|Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months|"The change in effect that HIV testing has on health beliefs (for example, I cannot get HIV) and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability"|Baseline, 12 Months|Enrolled participants who completed assessments on HIV invulnerability at baseline and 12 month.|||units on a scale||Standard Deviation|Mean
1347427|NCT01836445|Secondary|Mean Score of Health Protective Communication Skills at Baseline and 12 Months|The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).|Baseline, 12 Months|Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points Higher score = less HPC skills; range 1-4|||units on a scale||Standard Deviation|Mean
1347428|NCT01836445|Secondary|Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months|"At twelve months, the change in:~Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)~Social Norms (for example, partners, friends, or family members opinions about condom use)~Behavioral Skills (for example, negotiating condom use)~Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4"|Baseline, 12 Months|Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 12 month.|||units on a scale||Standard Deviation|Mean
1347429|NCT01836445|Secondary|Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months|"The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk."|Baseline, 12 Months|Enrolled participants who completed assessments on their HIV Knowledge at baseline and 12 month follow-up.|||percentage of correct responses||Standard Deviation|Mean
1347430|NCT01836445|Secondary|Mean Score of Condom Errors at Baseline and 12 Months|The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.|Baseline, 12 Months|Enrolled participants who completed assessments on their condom errors at baseline and 12 month follow-up.|||units on a scale||Standard Deviation|Mean
1347431|NCT01836445|Secondary|Mean Score of Health Protective Communication Skills at Baseline and 6 Months|The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).|Baseline, 6 Months|Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points|||units on a scale||Standard Deviation|Mean
1347432|NCT01836445|Secondary|Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months|"At six months, the change in:~Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)~Social Norms (for example, partners, friends, or family members opinions about condom use)~Behavioral Skills (for example, negotiating condom use)~Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4"|Baseline, 6 Months|Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 6 month.|||units on a scale||Standard Deviation|Mean
1347433|NCT01836445|Secondary|Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months|"The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk."|Baseline, 6 Months|Enrolled participants who completed assessments on HIV Knowledge at baseline and 6 month.|||percentage of correct responses||Standard Deviation|Mean
1347434|NCT01836445|Secondary|Mean Score of Condom Errors at Baseline and 6 Months|The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors|Baseline, 6 Months|Enrolled participants who completed assessments on condom errors at baseline and 6 month.|||units on a scale||Standard Deviation|Mean
1347435|NCT01836445|Secondary|Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months|The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.|Baseline, 12 Month|Enrolled participants who completed assessments on drug use before sex at baseline and 12 month.|||Participants|||Count of Participants
1347436|NCT01836445|Secondary|Mean Score of Health Protective Communication Skills at Baseline and 3 Months|The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).|Baseline, 3 Months|Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points|||units on a scale||Standard Deviation|Mean
1347437|NCT01836445|Secondary|Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months|"At three months, the change in:~Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)~Social Norms (for example, partners, friends, or family members opinions about condom use)~Behavioral Skills (for example, negotiating condom use)~Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4"|Baseline, 3 Months|Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 3 month.|||units on a scale||Standard Deviation|Mean
1347455|NCT01835899|Secondary|AUCt,1|Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1351313|NCT01780584|Other Pre-specified|Postoperative Time to Extubation|Postoperative time to extubation is length of time on ventilator.|up to 3 months after surgery||||hours||Full Range|Median
1347438|NCT01836445|Secondary|Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months|"The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk."|Baseline, 3 Months|Enrolled participants who completed assessments on HIV knowledge at baseline and 3 month follow-up.|||percentage of correct responses||Standard Deviation|Mean
1347439|NCT01836445|Secondary|Mean Score of Condom Errors at Baseline and 3 Months|The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.|Baseline, 3 Months|Enrolled participants who completed assessments on condom errors at baseline and 3 month follow-up.|||units on a scale||Standard Deviation|Mean
1347440|NCT01836445|Primary|Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.|12 months|"Enrolled participants who returned STI test kits for analysis at 12 month follow-up.~Denominator varies by testing site and study arm: urethral (control - 374; intervention - 359) rectal (control - 374; intervention - 356)"|||Participants|||Count of Participants
1347441|NCT01836445|Primary|Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.|Baseline|Enrolled participants who returned STI test kits for analysis at baseline. Denominator varies by testing site and study arm: urethral (control - 452; intervention - 441) rectal (control - 449; intervention - 442)|||Participants|||Count of Participants
1347442|NCT01836445|Primary|Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months|Change in self-report of condomless anal sex acts at twelve months.|Baseline, 12 Months|Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 12 month follow-up.|||Participants|||Count of Participants
1347443|NCT01836445|Primary|Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months|Change in self-report of condomless anal sex acts at six months.|Baseline, 6 Months|Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 6 month follow-up.|||Participants|||Count of Participants
1347444|NCT01836445|Primary|Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months|Change in self-report of condomless anal sex acts at three months.|Baseline, 3 Months|Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 3 month follow-up.|||Participants|||Count of Participants
1347445|NCT01836133|Secondary|Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease.|Baseline up to 3 years|The safety analysis population included all enrolled participants who received a single dose of erlotinib.|||Proportion of participants||95% Confidence Interval|Number
1347446|NCT01836133|Secondary|Percentage of Participants With Overall Response|Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.|Approximately 3 years|The effectiveness analysis population included all enrolled participants in the study.|||Percentage of participants||95% Confidence Interval|Number
1347447|NCT01836133|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.|Approximately 3 years|The effectiveness analysis population included all enrolled participants in the study.|||months||95% Confidence Interval|Median
1347448|NCT01836042|Primary|Rate of Sight-threatening Adverse Events|The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.|80 Month average||||percentage of subjects|||Number
1347449|NCT01835912|Other Pre-specified|Rate of Perceived Exertion|"Rate of perceived exertion (RPE) was recorded after each 200 metre swimming performance~RPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion)~Numbers reported are the average of the RPE recorded for all 10 participants."|Rate of Perceived Exertion after each 200m swimming performance||||units on a scale (6-20)||Standard Error|Mean
1347450|NCT01835912|Secondary|Lactate|lactate measured at 3min post trial|3 min post performance||||mmol/L||Standard Error|Mean
1347451|NCT01835912|Primary|Time|"time to complete 200 metre swimming performances in seconds~Participants chose type of swim stroke to swim a maximal effort 200 metre performance"|once each 200m performance||||seconds||Standard Error|Mean
1347452|NCT01835899|Secondary|AUCt,ss|Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1347457|NCT01835899|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug related Adverse events, as assessed by the investigator.|From first drug administration until last drug administration, upto 18 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||Percentage of participants|||Number
1347458|NCT01835756|Secondary|Satisfaction With Study Outcome|"At study endpoint, the subject was asked to rate how satisfied he or she was with any overall change in low back pain attained following the procedure administration phase with the Erchonia MLS Laser, using the following five-point scale:~Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied~Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|4 Months||||participants|||Number
1347459|NCT01835756|Secondary|Change in Low Back Pain Visual Analog Scale (VAS) Score|The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in low back pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of low back pain and is negative for study success. The mean change in low back pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 months post-procedure was calculated for each treatment group.|Baseline and 4 Months||||units on a scale||Standard Deviation|Mean
1347460|NCT01835756|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups|Primary outcome success for an individual subject was defined as a 30% or greater change (decrease) in VAS pain score at 4 months post-procedure relative to baseline. The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score indicates a greater level of pain, and a lower score indicates a lower level of pain. A negative (-) percent change in VAS rating indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success was defined as a 35% or greater difference in the proportion of individual primary outcome successes in each treatment group, in favor of the active treatment group.|4 Months||||participants|||Number
1347461|NCT01835743|Secondary|Change in Heel Pain Score on the Visual Analog Scale (VAS)|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Change in heel pain score on the VAS was calculated as the heel pain VAS score at week 5 (2 weeks after procedure administration end) minus the heel pain VAS score at baseline evaluation. A negative (-) change in heel pain VAS score across the evaluation period indicated a decrease (improvement) in heel pain and was positive for study success. A positive (+) change in heel pain VAS score indicated an increase (worsening) in heel pain and was negative for study success.|baseline and 5 weeks||||scores on a 0-100 VAS scale||Standard Deviation|Mean
1347462|NCT01835743|Primary|Number of Participants Who Attained a Change of -30% or Greater in the VAS Score|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Percent (%) change in VAS score was calculated as the % difference in VAS score at week 5 (2 weeks after procedure administration end) relative to baseline evaluation. A negative (-) % difference in VAS score across the evaluation period indicated a decrease (improvement) in heel pain, and a positive (+) % difference in VAS score indicated an increase (worsening) in heel pain. A change of -30% or greater in the VAS score was considered positive for study success. The number of participants who attained a change of -30% of greater in VAS score across the evaluation period was calculated for both subjects in the test group and in th placebo group as a proportion of the total number of subjects in each procedure group.|baseline and 5 weeks||||participants|||Number
1347463|NCT01835548|Secondary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Visit 9 (Day 43)|The safety population included all participants who took at least 1 dose of study drug.|||Participants|||Count of Participants
1347464|NCT01835548|Secondary|The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score|The PERMP consisted of 400 math problems and was graded as number of problems “Attempted” (PERMP-A) and number of problems “Correct.” (PERMP-C). It was an objective measure of performance during the classroom testing day.|Visit 8 (Day 42)|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||number of problems correct||Standard Deviation|Mean
1347465|NCT01835548|Secondary|The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score|The PERMP consisted of 400 math problems and was graded as number of problems “Attempted” (PERMP-A) and number of problems “Correct.” (PERMP-C). It was an objective measure of performance during the classroom testing day.|Visit 8 (Day 42)|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||number of problems attempted||Standard Deviation|Mean
1347484|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
1352112|NCT01769443|Secondary|Development of Angiographically Evident Cardiac Allograft Vasculopathy at 1 Year||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1347466|NCT01835548|Secondary|The Average of the SKAMP-Deportment Scores|The SKAMP Rating Scale is comprised of 2 behavioural subscales, including the “Deportment” subscale (4 items). The SKAMP-Deportment subscore evaluates behaviour in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behaviour. Ratings were based on the frequency and quality of behaviours.|Visit 8 (Day 42)|The Per-Protocol Set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized.|||score on a scale||Standard Deviation|Mean
1347467|NCT01835548|Secondary|The Average of the SKAMP-Attention Scores|The SKAMP Rating Scale was comprised of 2 behavioral subscales, including the “Attention” subscale (4 items). The SKAMP-Attention subscore evaluates concentration in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behavior. Ratings were based on the frequency and quality of behaviors.|Visit 8 (Day 42)|The per-protocol set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized.|||score on a scale||Standard Deviation|Mean
1347468|NCT01835548|Secondary|Duration of Effect|Duration of effect was defined as the last time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms, and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.|Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||hour|||Number
1347469|NCT01835548|Secondary|Onset of Effect|Onset of effect was defined as the first time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.|Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||hour|||Number
1347470|NCT01835548|Primary|Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score|The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period.|Visit 8 (Day 42)|The full analysis set (FAS) consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||score on a scale||Standard Deviation|Mean
1347471|NCT01835496|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 (apparent terminal elimination half-life) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval||||hr||Standard Deviation|Mean
1347472|NCT01835496|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ (area under the curve, zero to infinity) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval||||µg*hr/mL||Standard Deviation|Mean
1347473|NCT01835496|Primary|Tmax for Deferiprone and Deferiprone 3-O-glucuronide|"Tmax (time to the maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|10-hour interval||||hr||Full Range|Median
1347474|NCT01835496|Secondary|Frequency of Serious Adverse Events||From Day 1 (Dosing) to Day 30 post-dose||||participants|||Number
1347475|NCT01835496|Secondary|Frequency of Adverse Events||From Day 1 (Dosing) to Day 7 plus/minus 3 days (Follow-up)||||participants|||Number
1347476|NCT01835496|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval||||μg/mL||Standard Deviation|Mean
1347485|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
1347486|NCT01835431|Secondary|Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes|The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
1350081|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
1347477|NCT01835470|Secondary|Number of Participants With Positive Immunogenicity During the Short Term Period|A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose.|Day 1 up to Week 16 (Day 113)|Immunogenicity analysis population: All participants who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication|||participants|||Number
1347478|NCT01835470|Secondary|Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period|Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1347479|NCT01835470|Secondary|Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period|Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1347480|NCT01835470|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first.|Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months|All Treated Participants: All participants who received at least one dose of study medication|||participants|||Number
1347481|NCT01835470|Secondary|Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16|Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication|||percentage of improvement from baseline||Inter-Quartile Range|Median
1347482|NCT01835470|Secondary|Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16|ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician’s global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication|||percentage of participants||95% Confidence Interval|Number
1347483|NCT01835470|Primary|Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16|American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication|||percentage of participants||95% Confidence Interval|Number
1347597|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <70mg/dl is an equivalent indicator of hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."||||||
1347487|NCT01835431|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)|"Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).~Confirmed hypoglycaemic episodes were defined as episodes that were either:~Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or~An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
1347488|NCT01835431|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment.|After 16 weeks of treatment|The Safety analysis set (SAS) included all subjects receiving at least one dose of the trial product or its comparator|||number of events|||Number
1347489|NCT01835431|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|week 0, week 16|The FAS included all randomised subjects. 338 subjects had assessment at baseline, 326 had assessment at week 16, 2 subjects were withdrawn before exposure and 22 subjects week 16 assessment was not done.|||mmol/L||Standard Deviation|Mean
1347490|NCT01835431|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|Week 0 to week 16|The FAS included all randomised subjects. 20 subjects were withdrawn and only 4 subjects though completed the study did not have assesments.|||percentage (%)||Standard Deviation|Mean
1347491|NCT01835379|Secondary|Time to Wound Closure|Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.|During the 12 Week treatment period||||weeks||95% Confidence Interval|Median
1347492|NCT01835379|Primary|Percentage of Wounds Closed||At the end of 12 Weeks||||percentage of wounds closed|||Number
1347493|NCT01835262|Primary|Numeric Rating Scale of Pain|"We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes.~Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain"|30 minutes||||Units on a scale||Standard Deviation|Mean
1347494|NCT01835132|Secondary|Changes in Scleral Grading From Baseline to Week 52|Scleral inflammation was summarized on an ordinal scale as either none, minimal/trace, mild, moderate, severe or necrotizing inflammation in the four quadrants of the study eye (superonasal [SN], superotemporal [ST], inferotemporal [IT], and inferonasal [IN]) for each participant at each visit. The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.|Baseline and Week 52|The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.||||||
1347495|NCT01835132|Secondary|Number of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Post-injection through study completion, up to 78 weeks per participant|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||participants|eyes||Number
1347496|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
1347497|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
1347498|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
1347499|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
1347500|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.~Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg)."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
1347501|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347502|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347503|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347504|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347505|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347506|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Mean Change in Intraocular pressure (IOP) is measured and reported as change in IOP between baseline and 24 weeks in millimeters of mercury (mmHg).|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347507|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347508|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347509|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347510|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347511|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347598|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)|Day 2-5|Day 2-5||||mg/dl||Standard Deviation|Mean
1347512|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
1347513|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
1347514|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
1347515|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
1347516|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
1347517|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.~Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
1347518|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347519|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347520|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347521|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347522|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347523|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347524|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347525|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347526|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347527|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347528|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347529|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
1347530|NCT01835132|Primary|Number of Participants With at Least a 2-step Reduction or Reduction to Grade 0 in Scleral Inflammation in the Study Eye (or Eyes), According to the National Eye Institute (NEI) Photographic Scleritis Grading System, on or Before the Week 16 Visit.|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show).|Baseline and Week 16||||participants|||Number
1347531|NCT01835015|Secondary|Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
1347532|NCT01835015|Secondary|The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
1347533|NCT01835015|Secondary|Terminal Elimination Half-life (T½)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
1347534|NCT01835015|Secondary|"Area Under the Serum Concentration-time Curve From Time Zero to Time t Where t is a Defined Time Point After Administration [AUC(0-t)]"|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
1347535|NCT01835015|Secondary|Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hr*ng/mL/mg||Standard Deviation|Mean
1347536|NCT01835015|Secondary|Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||ng/mL/mg||Standard Deviation|Mean
1347537|NCT01835015|Secondary|Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hours||Standard Deviation|Mean
1347538|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hr*ng/mL||Standard Deviation|Mean
1347539|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hr*ng/mL||Standard Deviation|Mean
1347540|NCT01835015|Primary|Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment|A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.|||participants|||Number
1347541|NCT01835015|Primary|Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment|A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.|||participants|||Number
1347542|NCT01835015|Primary|Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye|IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||mmHg||Standard Deviation|Mean
1347543|NCT01835015|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||letters||Standard Deviation|Mean
1347544|NCT01834651|Secondary|Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death|This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.|From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.|Only 12 samples were analyzed.|||Participants|||Count of Participants
1347545|NCT01834651|Secondary|Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)|Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)|Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.|All patients|||Participants|||Count of Participants
1347546|NCT01834651|Secondary|Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration|Mean change from baseline in levels of HGF and VEGF|12 weeks|HGF was evaluable in 16 patients who had viable research samples. VEGF was evaluable in 15 patients who had viable research samples.|||pg/ml||Standard Deviation|Mean
1347547|NCT01834651|Secondary|Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells|This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)|12 weeks|There were 16 patients evaluable for this outcome (1 patient did not have RECIST measurable disease)|||Participants|||Count of Participants
1347548|NCT01834651|Secondary|Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib|Change in number of CTC from baseline at 12 weeks|Baseline and 12 weeks||||CTCs/7.5 ml||Standard Deviation|Mean
1347549|NCT01834651|Primary|Clinical Benefit Rate From Cabozantinib (XL184)|"Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria.~Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) >=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease."|Baseline to 12 weeks after starting therapy||||Participants|||Count of Participants
1347550|NCT01834586|Secondary|Average Pain Rating|Average Pain Rating over 24-hours, defined as the average injection-site pain over 24-hours on a 0-10 VAS (0 = no pain, 10 = worst pain).|baseline and two weeks||||units on a scale||Standard Deviation|Mean
1347551|NCT01834586|Primary|Pain Rating|"Primary Outcome Measure~•Change from baseline in rating of pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog Scale (VAS, 10 = worst pain, 0 = no pain)Pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog scale (VAS, 10 = worst pain, 0 = no pain)."|baseline and two weeks of treatment|completing participants|||units on a scale||Standard Deviation|Mean
1347552|NCT01834404|Secondary|Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)|Plasma gastrointestinal hormone PYY was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal||||pg/mL||Standard Error|Mean
1347553|NCT01834404|Secondary|Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)|Plasma gastrointestinal hormone GLP-1 was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal||||pg/mL||Standard Error|Mean
1347554|NCT01834404|Secondary|Peak Postprandial Level of Cholecystokinin (CCK)|Plasma gastrointestinal hormone CCK was measured by radioimmunoassay based on an antibody with very low cross-reactivity to gastrin 17 and its sulfated counterpart, and to sensitivity to a concentration of 0.3 pmol/L.|Day 14, approximately 45 minutes after liquid meal||||pg/mL||Standard Error|Mean
1347555|NCT01834404|Secondary|Fasting Ghrelin|Plasma gastrointestinal hormone total ghrelin was measured by radioimmunoassay.|Day 14, before liquid meal||||pg/mL||Standard Error|Mean
1347599|NCT01833988|Secondary|Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)||1 week||||mg/dl||Standard Deviation|Mean
1347600|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise||1 week|Individual data during exercise was not analyzed. No episodes of severe hypoglycemia were observed on bionic pancreas and only 1 episode of severe hypoglycemia occurred in usual care arm (insulin pump)|||Participants|||Count of Participants
1347556|NCT01834404|Secondary|Change in Postprandial Gastric Volume|Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately approximately 30 min after liquid meal||||mL||Standard Error|Least Squares Mean
1347557|NCT01834404|Secondary|Solid Gastric Emptying: Proportion Remaining at 4 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal remaining at 4 hours.|Day 15, approximately 4 hours after radiolabeled meal was ingested||||proportion of meal remaining||Standard Error|Least Squares Mean
1347558|NCT01834404|Primary|Buffet Meal Intake|"At visit 4 subjects underwent imaging to measure the volume of their stomach, fasting and after ingesting a liquid nutrient drink. Four hours after the liquid meal, subjects were invited to eat, over a 30-minute period, a standard all you can eat meal vegetable lasagna, vanilla pudding, and skim milk. The total Kcal of the food consumed was analyzed by using validated software."|Day 13, approximately 4.5 hours after liquid meal||||Kcal||Standard Error|Mean
1347559|NCT01834404|Primary|Maximum Tolerated Volume|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reached level 5.|Day 14, approximately 30 minutes after liquid meal||||mL||Standard Error|Mean
1347560|NCT01834404|Primary|Volume to Fullness|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Day 14, approximately 30 minutes after liquid meal||||mL||Standard Error|Mean
1347561|NCT01834404|Primary|Postprandial Gastric Volume|Postprandial gastric volume was measured by 99mTc-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. After the liquid meal tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 30 minutes after liquid meal||||mL||Standard Error|Mean
1347562|NCT01834404|Primary|Fasting Gastric Volume|Fasting whole gastric volume was measured by Technetium (99mTc)-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 10 minutes after Technetium (99mTC) injection||||mL||Standard Error|Mean
1347563|NCT01834404|Secondary|Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.|Day 15, approximately 2 hours after radiolabeled meal was ingested||||proportion of meal emptied||Standard Error|Least Squares Mean
1347564|NCT01834404|Primary|Gastric Emptying of Solids Half-Time (T 1/2)|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals.|Day 15, approximately 2 hours after radiolabeled meal was ingested||||minutes||Standard Error|Mean
1347565|NCT01834274|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.|||mmol/L||Standard Deviation|Mean
1347566|NCT01834274|Secondary|Percentage of Participants With HbA1c <7% at Week 24|The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment.|Week 24|As pre-defined in the SAP, no summary is provided for the secondary efficacy endpoint incidence of HbA1c <7% at Week 24 due to the limited enrollment and study duration at the time of study termination.||||||
1347567|NCT01834274|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.|||Percent||Standard Deviation|Mean
1347601|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise||1 week|Data on exercise not collected||||||
1347602|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)||1 week|Fraction of time < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl|||percentage of time||Standard Deviation|Mean
1347568|NCT01834261|Secondary|Functional Connectivity Between OFC and AMY|"During functional scans, subjects participated in an interactive neuroeconomic game, an iterative version of the classical “Trust Study.” Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds).~Using Dynamical Causal Modeling (DCM) we modeled the dynamic interaction between amygdala (AMY), nucleus accumbens (NAcc) and the orbitofrontal cortex (OFC). We observed altered connectivity strength between AMY and OFC under OT as compared to PL conditions."|Within two weeks of enrollment completion.|Healthy adult men (17 subjects completed the task fMRI (Trust Study) at MGH, remaining 3 subjects at MGH did not complete the task). The values reported for connections strengths below (0.45 and 0.18) are from the Bayesian Parameter Averaging. The measure of precision is the associated posterior probability, which is 1 for both.|||Hz||Standard Deviation|Mean
1347569|NCT01834261|Primary|Number of Malevolent Rounds|"This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Malevolent rounds were defined as those with decreased investment ratios even after an increased repayment ratio."|Immediately after completion of the study, for each subject.|Healthy adult men.|||number of rounds||Standard Deviation|Mean
1347570|NCT01834261|Primary|Number of Benevolent Rounds|"This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Benevolent rounds were defined as those with increased investment ratios even after a decreased repayment ratio."|Immediately after completion of the study, for each subject.|Healthy adult men.|||number of rounds||Standard Deviation|Mean
1347571|NCT01834222|Primary|Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug|Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of adverse events|||Number
1347572|NCT01834222|Primary|Number of Participants Who Discontinued Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
1347573|NCT01834222|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no (resolved)' during study.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
1347574|NCT01834222|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.|||participants|||Number
1347575|NCT01834222|Primary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.|||days||Standard Deviation|Mean
1347603|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements||Day 1-5||||events|||Number
1347604|NCT01833988|Secondary|Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period||Day 2-5||||percentage of days||Standard Deviation|Mean
1347605|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl||Day 2-5||||Participants|||Count of Participants
1347576|NCT01834222|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non­serious AE.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.|||participants|||Number
1347577|NCT01834027|Secondary|Mean Blood Pressure|non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes|60 minutes|||||||
1347578|NCT01834027|Secondary|Mean Difference in Patient's Perception of Pain From Baseline|The patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated.|10, 20 , and 30 minutes after baseline measurement||||units on a scale||95% Confidence Interval|Mean
1347579|NCT01834027|Secondary|Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU|Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated.|Once, at 30 minutes after the patient entered the PACU|2 participants in the jazz group nad 1 participant in the no music group did not provide an anxiety score.|||units on a scale||Standard Deviation|Mean
1347580|NCT01834027|Primary|Change in Heart Rate From Baseline on Arrival in PACU|Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry|5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU||||beats per minute||95% Confidence Interval|Mean
1347581|NCT01833988|Other Pre-specified|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose||1 week||||unit/kg/day||Standard Deviation|Mean
1347582|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night||1 week||||interventions|||Number
1347583|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia||1 week||||number of interventions|||Number
1347584|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <50mg/dl at nightime is an equivalent indicator of severe overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."||||||
1347585|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <70mg/dl at nightime is an equivalent indicator of overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."||||||
1347586|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night||1 week||||percentage of time||Standard Deviation|Mean
1347587|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night|Day 2-5|Day 2-5||||mg/dl||Standard Deviation|Mean
1347588|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)||1 week||||percentage of time||Standard Deviation|Mean
1347589|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night||1 week||||percentage of time||Standard Deviation|Mean
1347590|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.||1 week||||mg/dl||Standard Deviation|Mean
1347591|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)||1 week||||Standard deviation of mean values|||Number
1347592|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.|"Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges.~%<70 70–120 70–180 %>180 %>250"|1 week||||Standard deviation of mean values|||Number
1347593|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise||1 week|Data not obtained for exercise period||||||
1347594|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals||1 week|Data was not collected to measure this outcome||||||
1347595|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl||1 week||||Participants|||Count of Participants
1347596|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <50mg/dl is a n equivalent indicator of severe hypoglycemia instead of area over the curve, and can be used to compare outcomes with other studies."||||||
1347606|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements.|Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring.|1 week|This data was not analysed to prevent bias. This information would have been misleading (unscheduled BG checks were performed to confirm a low BG mostly). Overall CGM trend, incidence/duration of hypoglycemia and BG trend during and after exercise is separately analyzed under other secondary outcomes.||||||
1347607|NCT01833988|Primary|Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm||1 week||||percentage of time||Standard Deviation|Mean
1347608|NCT01833988|Primary|Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.||1 week||||mg/dL||Standard Deviation|Mean
1347609|NCT01833936|Primary|Reduce Calf Muscle Atrophy|Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy.|Pre-operative, 2 weeks, and 6 weeks post-operative|Pre-operatively, 20 subjects were analyzed per arm. Due to subject withdrawal, 19 were available in Group 1 at 2 weeks; and only 16 were available in Group 1 at 6 weeks, and 10 were available in Group 2 at 6 weeks.|||mm^2||Standard Deviation|Mean
1347610|NCT01833897|Secondary|Beck's Depression Inventory|Range 0-63, with higher scores worse. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|8 weeks||||units on a scale (final score)||Standard Deviation|Mean
1347611|NCT01833897|Secondary|Hamilton Anxiety Scale|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indi- cates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe.|8 weeks||||units on a scale (final score)||Standard Deviation|Mean
1347612|NCT01833897|Secondary|HAM-D Suicide Item|Ham-D suicide item: range 0-4, higher scores indicate worse symptoms|8 weeks||||units on a scale (final)||Standard Deviation|Mean
1347613|NCT01833897|Secondary|Loss of Motivated Behavior HAM-D Factor|includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms|8 weeks|bipolar depression|||units on a scale (final score)||Standard Deviation|Mean
1347614|NCT01833897|Primary|Hamilton Depression Rating Scale (HAM-D)|"Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|8 weeks|bipolar depression|||units on a scale (final score)||Standard Deviation|Mean
1347615|NCT01833845|Secondary|Efficacy|To evaluate the efficacy of 8 weeks monotherapy with RBV in HCV-infected patients.|8 weeks|||||||
1347616|NCT01833845|Primary|Safety: Number of Participants With Adverse Events|Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms.|all 24 weeks||||participants|||Number
1347617|NCT01833845|Primary|Efficacy|To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.|24 weeks|||||||
1347618|NCT01833741|Primary|Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12|||Percentage of Patients|||Number
1347619|NCT01833741|Primary|Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12|||Percentage of Patients|||Number
1347620|NCT01833741|Secondary|Percentage of Patients Discontinuing Due to Ocular Adverse Events|Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.|12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percentage of Patients|||Number
1347621|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1347622|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1347634|NCT01833481|Primary|Kinematics - Stance Phase Separation|Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.|6 months post-operative||||mm||Standard Deviation|Mean
1347623|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1347624|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percent Change||Standard Deviation|Mean
1347625|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percent Change||Standard Deviation|Mean
1347626|NCT01833741|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percent Change||Standard Deviation|Mean
1347627|NCT01833741|Primary|Percentage of Treatment-Naive Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12|||Percentage of Patients|||Number
1347628|NCT01833533|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.|||percentage of participants||95% Confidence Interval|Number
1347629|NCT01833533|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).|||percentage of participants|||Number
1347630|NCT01833533|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1347631|NCT01833533|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.|||percentage of participants|||Number
1347632|NCT01833533|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1347633|NCT01833481|Primary|Kinematics - Overall Separation|Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance|6 months post-operative||||mm||Standard Deviation|Mean
1347638|NCT01833247|Post-Hoc|Salivary and Capillary Lactic Acid Will be Correlated After a Seizure|Salivary levels of lactic acid is being studied because saliva is more accessible in the outpatient setting than is blood. Concentration of lactic acid in the serum and saliva from each individual subject will be correlated using Pearson's correlation test. We will consider a positive outcome to be a r greater than or equal to 0.5 and significance at p<0.05.|Within 10 minutes of a seizure|||||||
1347639|NCT01833247|Primary|Intravenous Lactic Acid Levels With Seizures|The investigators will assess the intravenous lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in serum collected by IV, immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure|Data were collected from one participant|||mmol/L|||Number
1347640|NCT01833247|Primary|Capillary Lactic Acid Levels With Seizures|The investigators will assess the capillary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in blood, within 10 minutes after the end of a seizure. Units of measurement will be mM/L. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure|Data were collected from 6 of the 12 enrolled subjects|||mmol/L||Standard Deviation|Mean
1347641|NCT01833247|Primary|Salivary Lactic Acid Levels With Seizures|The investigators will assess the salivary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in saliva , immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure||||mmol/L||Standard Deviation|Mean
1347642|NCT01833169|Secondary|Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|baseline up to 30 months||||percentage of participants||95% Confidence Interval|Number
1347643|NCT01833169|Secondary|Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|baseline up to 24 months||||months||95% Confidence Interval|Median
1347644|NCT01833169|Secondary|Overall Survival - Number of Participants With an Event|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|Every 8 Weeks until death, assessed up to 24 months||||participants|||Number
1347645|NCT01833169|Secondary|Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.|baseline up to 24 months||||percentage of participants||95% Confidence Interval|Number
1347646|NCT01833169|Secondary|Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause|baseline up to 24 months||||months||95% Confidence Interval|Median
1347647|NCT01833169|Secondary|Progression-Free Survival - Number of Participants With an Event|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause|Every 8 Weeks until death, assessed up to 24 months||||participants|||Number
1347648|NCT01833169|Secondary|Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum Diameters|Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply|baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months||||percentage of patients||95% Confidence Interval|Number
1347649|NCT01833169|Primary|Participant Clinical Benefit Response Rate|Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at >=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline|Week 16||||percentage of participants||95% Confidence Interval|Number
1347650|NCT01833130|Secondary|Change From Baseline in the Emotional Function (EF) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347651|NCT01833130|Secondary|Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1348437|NCT01822119|Other Pre-specified|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.|Visit 2 (surgery)|Intention-to-Treat population, includes all patients who received surgical intervention.|||participants|||Number
1347652|NCT01833130|Secondary|Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347653|NCT01833130|Secondary|Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347654|NCT01833130|Secondary|Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347655|NCT01833130|Secondary|Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347656|NCT01833130|Secondary|Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347657|NCT01833130|Secondary|Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347658|NCT01833130|Secondary|Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347659|NCT01833130|Secondary|Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347660|NCT01833130|Secondary|Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347661|NCT01833130|Secondary|Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347662|NCT01833130|Secondary|Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347663|NCT01833130|Secondary|Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347664|NCT01833130|Secondary|Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347665|NCT01833130|Primary|Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
1347666|NCT01833117|Secondary|Area Under Curve (AUC) of TBUT From 0 to 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|0 to 60 minutes|This analysis population includes all randomized participants.|||seconds x hours||Standard Deviation|Mean
1347667|NCT01833117|Primary|Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|Baseline, 60 minutes|This analysis population includes all randomized participants.|||seconds||Standard Error|Mean
1347668|NCT01833078|Secondary|Sustainability of Increased Caloric Intake|Sustained food intake of standardized meal from Days 1 compared to Day 7.|pre-treatment baseline (day 1) through day 7||||calories||Full Range|Median
1347669|NCT01833078|Primary|Safety|1.Safety: # of participants with treatment emergent adverse events|pre-treatment baseline through 30 days following the last administration of study treatment day 7||||participants|||Number
1347670|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1347671|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1347672|NCT01833065|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).~For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1347673|NCT01833065|Secondary|Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.~PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.~Total PAC-QOL score was averaged from the individual item score."|At Week 12|The ITT analysis set consisting of all randomized (as planned) patients.|||Percentage of patients|||Number
1347693|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|Pharmacokinetic (PK) analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect PK results and who received at least first dose of study drug according to protocol providing sufficient concentration time data to determine PK endpoints for the study drug.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1347739|NCT01831921|Secondary|Body Weight|Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.|Baseline, 6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||kilograms||Standard Deviation|Mean
1347674|NCT01833065|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .~For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on BSFS||95% Confidence Interval|Least Squares Mean
1347675|NCT01833065|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||SBM per week||95% Confidence Interval|Least Squares Mean
1347676|NCT01833065|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).|Within first 24 hours of treatment initiation|The ITT analysis set consisting of all randomized (as planned) patients.|||Percentage of patients|||Number
1347677|NCT01833065|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|The ITT analysis set consisting of all randomized (as planned) patients.|||Percentage of patients|||Number
1347678|NCT01832766|Other Pre-specified|Brief Psychiatric Rating Scale Change From Baseline at 1 Hour|Measures psychiatric symptoms. Each item is scored from 1-7. Positive symptoms are calculated from sum of scores on hallucinatory behavior, unusual thought content and conceptual disorganization. Thus, the range of Total Positive Symptoms can be from a score of 3-21 .The higher the score, the more severe the symptom. Negative symptoms have been calculated from sum of blunted affect, emotional withdrawal and motor retardation. The range of Total Negative Symptoms can be from a score of 3-21. The higher the score, the more severe the symptoms. As this is a difference from baseline, there can be either negative or positive results as the subjects can either be better than baseline (positive score) or worse than baseline (negative score).|at 1 hour after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).|||units on a scale||Standard Deviation|Mean
1347679|NCT01832766|Secondary|California Verbal Learning Test Change at 2 Hours From Baseline|ability to remember a list of words given 5 trials. Number of words remembered is normalized to a schizophrenia population and average scores are calculated with age correction. The normal T-score is 50 and scores greater than 50 correspond with greater ability to remember words as compared to a schizophrenia population norm.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).|||T scores||Standard Deviation|Mean
1347680|NCT01832766|Primary|P50 Auditory Evoked Potential|electrophysiological measure of ability to filter extraneous stimuli measured as the amplitude of the evoked response to the second auditory stimulus divided by the amplitude of the evoked response to the first auditory stimulus in mV.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).|||test to conditioning ratio||Standard Deviation|Mean
1347681|NCT01832506|Secondary|Progression-free Survival (PFS)|PFS was defined as the time in months from the first administration of trial treatment until first observation of progressive disease (PD), or death due to any cause when death occurs within 12 weeks of the last tumor assessment or first administration of trial treatment (whichever is later). Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment. PFS was planned to be presented for “MSC2156119J Combined” reporting arm.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||months||90% Confidence Interval|Median
1347682|NCT01832506|Secondary|Number of Subjects With Clinical Benefit|Clinical Benefit was defined as CR or PR at any time point or SD at week 12 or later, based on tumor assessment as determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
1347737|NCT01831921|Secondary|Diastolic Blood Pressure|Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.|Baseline, 6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||mmHg||Standard Deviation|Mean
1348438|NCT01822119|Other Pre-specified|Time to Perform Surgery||Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||minutes||Standard Deviation|Mean
1347683|NCT01832506|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
1347684|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Multiple Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the LLQ. AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347685|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Single Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLQ) AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347686|NCT01832506|Secondary|Apparent Volume of Distribution Associated To The Terminal Phase (Vz/f) of MSC2156119J|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed and is calculated by Dose/(AUC(inf)*λz).|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of the Vz/f.||||||
1347687|NCT01832506|Secondary|Apparent Body Clearance (CL/f) of MSC2156119J|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. CL/F = Dose/AUC(inf), where AUC(inf) =AUC0-t + AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
1347688|NCT01832506|Secondary|Area Under the Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC[Inf]) of MSC2156119J|AUC(inf) was calculated by combining AUC0-t and AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUCinf.||||||
1347689|NCT01832506|Secondary|Apparent Terminal Half-life (t1/2) of MSC2156119J|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base 2 (Ln2) divided by elimination rate constant (λz), where ‘λz’ is calculated by a linear regression of the log-linear concentration-time curve.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
1347690|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.|||hours||Full Range|Median
1347691|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.|||hours||Full Range|Median
1347692|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347694|NCT01832506|Secondary|Number of Subjects With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 2 or Higher|ECOG PS score is widely used by doctors and researchers to assess how a subjects’ disease is progressing, and is used to assess how the disease affects the daily living abilities of the subject, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 4, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.|Baseline up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
1347695|NCT01832506|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs or TEAEs Leading To Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline Up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
1347696|NCT01832506|Primary|Number of Subjects Experiencing Dose Limiting Toxicity (DLT)|DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (>=) Grade 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding; >=Grade 3 nausea despite adequate treatment; >=Grade 3 any non-hematological AE (DLT defined specifically for following cases: >=Grade 3 liver adverse event [AE] requiring recovery period of more than 7 days or to Grade 1 without liver metastases or Grade 2 with liver metastases ; >=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of >=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and >=Grade 2 any AE not otherwise defined as DLT that, due to prolonged recovery to Grade 1 (or less) or baseline status, led to delay of treatment with IMP for more than 21 days.|Cycle 1 (Day 1 up to 21)|DLT analysis set included all subjects who completed Cycle 1 (having received 80% or more of planned cumulative dose of IMP for Cycle 1) or who stopped treatment with IMP during Cycle 1 because of DLT.|||subjects|||Number
1347697|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.|||participants|||Number
1347698|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.|||participants|||Number
1347699|NCT01832493|Primary|AV Interval Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.|||participants|||Number
1347700|NCT01832493|Primary|AV Interval Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.|||participants|||Number
1347701|NCT01832259|Secondary|Time to Biochemical Recurrence|Progression free survival was measured using time to biochemical recurrence. Time to biochemical recurrence was defined as the number of days elapsed between prostatectomy and the first recording of a Prostate Specific Antigen (PSA) value of greater than or equal to 0.2 ng/mL. Patients were followed for up to two years following prostatectomy.|2 years|||||||
1347702|NCT01832259|Secondary|Participants Experiencing Adverse Events|Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4. Each event was assigned a grade (1-5), with lower grades indicating milder events. All adverse events were recorded, regardless of attribution to study treatment. For a full listing of Adverse Events, please see the Adverse Events section of the Results for this study.|From first dose of study treatment to one month post-prostatectomy (approximately 2 months)||||Participants|||Count of Participants
1347703|NCT01832259|Primary|Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters|Patients with high-risk, localized prostate cancer were treated with 28 days of Pazopanib or placebo, after which they underwent radical prostatectomy. During prostatectomy, benign pelvic lymph node tissue was collected and subsequently analyzed for the average number of VEGFR1-positive clusters in 8 distinct 40x microscopic fields as an indicator of pre-metastatic niche formation.|1 month|The tissue of one patient on the Pazopanib arm and two patients on the Placebo arm was not able to be analyzed. Another patient on the Pazopanib arm had surgery delayed by a few weeks following stopping study medication and was determined to be unevaluable, resulting in 13 patients analyzed on each arm.|||VEGFR1+ clusters per hpf||Standard Deviation|Mean
1347704|NCT01832155|Other Pre-specified|Feasibility Measure - Recruitment|The number of months it took to recruit 36 participants.|9 months||||months|||Number
1347705|NCT01832155|Primary|Absolute Value of OA Pain at 8 Weeks|A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.|8 weeks||||Number of pain medication/day||Standard Error|Mean
1347706|NCT01832155|Other Pre-specified|Feasibility Measure - Safety|Safety was assessed by measuring the frequency of yoga related injuries that occur from group or home-based exercise sessions during the active treatment periods.|8 weeks||||injuries|||Number
1347707|NCT01832155|Other Pre-specified|Feasibility Measure - Acceptability|"Acceptability was evaluated by the participants' perceived difficulty of the yoga class and level of enjoyment. Upon completion of the yoga program, perceived level of program difficulty was rated by participants using a scale of 1 - 10 where 10 represents extremely difficult and a scale of 1 - 10 where 10 represents most enjoyable was used to measure perceived level of program enjoyment. Data from both intervention and wait-list control (during the intervention period) groups were collected."|8 weeks||||units on a scale||Full Range|Mean
1347708|NCT01832155|Other Pre-specified|Feasibility Measures - Adherence|Feasibility was also measured by the home practice adherence rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Home yoga practice adherence was determined by participants' report of the average number of minutes of yoga practiced at home.|8 Weeks||||minutes/week||Full Range|Mean
1347709|NCT01832155|Other Pre-specified|Feasibility Measures - Retention|Feasibility was measured by the retention rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Participants' class attendance (average number of classes attended) was evaluated.|8 weeks||||classes||Full Range|Mean
1347710|NCT01832155|Secondary|Absolute Value of BMI at 8 Weeks|BMI was calculated using the participant's weight and height, kg/m^2.|8 weeks||||kg/m^2||Standard Error|Mean
1347711|NCT01832155|Secondary|Absolute Value of Quality of Life at 8 Weeks|"The self-perceived quality of life was assessed using the Short Form Health Survey (SF-12) which measures a total of 8 health domains: 4 physical and 4 mental component summary scales. Physical Health (physical functioning, role-physical, bodily pain, and general health)and Mental Health (vitality, social functioning, role-emotional, and mental health) Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The Cantril Self-Anchoring Ladder that measures both current and in 5 years using steps from 0 to 10, where 0 represents the worst possible life and 10 represents the best possible life."|8 weeks||||units on a scale||Standard Error|Mean
1347712|NCT01832155|Secondary|Absolute Value of Quality of Sleep at 8 Weeks|Pittsburgh Sleep Quality Index (PSQI) was used to measure quality of sleep. The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0–3 whereby 3 reflects the negative extreme on the Likert Scale. The 7 component scores are added to obtain a global score ranging from 0–21, with higher scores indicating worse sleep quality. A global score of ≥ 5 on the PSQI total scale, which is computed as a sum of the seven subscales (e.g., sleep quality, sleep latency, sleep duration, sleep disturbance, sleep efficiency, and use sleep medication) is associated with clinically significant sleep disruptions, including insomnia and major mood disorders.|8 weeks||||units on a scale||Standard Error|Mean
1347713|NCT01832155|Secondary|Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks|"Secondary outcome measures included physical performance of the LE which was assessed using the Short Physical Performance Battery (SPPB) developed by the National Institute on Aging. The test consists of three components: repeated chair stands (4 points), balance (4 points), and timed 8 walk (4 points). A maximum score of 12 points can be achieved. Higher values indicate better physical functions."|8 weeks||||units on a scale||Standard Error|Mean
1347714|NCT01832155|Primary|Absolute Value of OA Symptoms at 8 Weeks|Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Mean
1347715|NCT01832090|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment|To evaluate the efficacy of Radiesse for hand treatment as measured by live, subject-completed Global Aesthetic Improvement Scale (GAIS) scores between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||percentage of participants|Hands||Number
1347738|NCT01831921|Secondary|Systolic Blood Pressure|Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.|Baseline, 6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||mmHg||Standard Deviation|Mean
1350457|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years who received on-demand therapy were included in the analysis.|||IU||Standard Deviation|Mean
1347716|NCT01832090|Secondary|≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||percentage of participants|||Number
1347717|NCT01832090|Secondary|≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||% hands with ≥ 1 point MHGS change|Hands||Number
1347718|NCT01832090|Secondary|Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects receiving retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||units on a scale|Hands|Standard Deviation|Mean
1347719|NCT01832090|Secondary|Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||units on a scale|Hands|Standard Deviation|Mean
1347720|NCT01832090|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only|To evaluate the efficacy of Radiesse for hand treatment by evaluating subject-reported, live Global Aesthetic Improvement Scale (GAIS) ratings at 3 months when compared to baseline among the original treatment group only|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of participants|Hands||Number
1347721|NCT01832090|Secondary|Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only|"To evaluate the efficacy of Radiesse for hand treatment by comparing the evenness in the left hand versus the right hand at 3 months using the 5-point Merz Hand Grading Scale (MHGS) among the original treatment group only. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of participants|||Number
1347722|NCT01832090|Secondary|≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of participants|||Number
1347723|NCT01832090|Secondary|≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of hands|Hand||Number
1348232|NCT01826370|Secondary|Change From Baseline to Week 24 of HbA1c|Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for HbA1c.|||percentage of HbA1c||Standard Deviation|Mean
1347724|NCT01832090|Secondary|Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||units on a scale|Hands|Standard Deviation|Mean
1347725|NCT01832090|Primary|≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.|||percentage of participants|||Number
1347726|NCT01832090|Primary|≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.|||percentage of hands|Hands||Number
1347727|NCT01832090|Primary|Mean Change on Merz Hand Grading Scale (MHGS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.|||units on a scale|Hands|Standard Deviation|Mean
1347728|NCT01831934|Other Pre-specified|Measurement of Intracellular Glutathione by Hi-D FACS (CD4 and CD8 T Cells) and Tandem Mass Spectrometry (Whole Blood)|This method relies on the ability of intracellular glutathione S-transferases to tag GSH to bimane to yield a bimane-GS conjugate that fluoresces at 440 nm.|Day 0-Day28|||||||
1347729|NCT01831934|Primary|Clinical Safety of TIV Vaccine|We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization|Day 0 to Day28||||Participants|||Count of Participants
1347730|NCT01831921|Secondary|Triglycerides|Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.|Baseline, 12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
1347731|NCT01831921|Secondary|Low Density Lipoprotein (LDL)|Mean LDL in both treatment groups at 12 and 24 months will be calculated.|Baseline, 12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
1347732|NCT01831921|Secondary|High Density Lipoprotein (HDL)|Mean HDL in both treatment groups at 12 and 24 months will be assessed.|Baseline, 12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
1347733|NCT01831921|Other Pre-specified|Homeostasis Model of Insulin Resistance (HOMA IR)|Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.|6, 12, and 24 months||2018-10-31|10/2018||||
1347734|NCT01831921|Other Pre-specified|Fasting Insulin|Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.|6, 12, and 24 months||2018-10-31|10/2018||||
1347735|NCT01831921|Secondary|Total Cholesterol|Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.|Baseline, 12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
1347736|NCT01831921|Secondary|Fasting Glucose|Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.|Baseline, 6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||mg/dL||Standard Deviation|Mean
1347740|NCT01831921|Primary|Hemoglobin A1c|Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.|Baseline, 6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||percent HbA1c||Standard Deviation|Mean
1347741|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1347742|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1347743|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 8|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1347744|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 4|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1347745|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 8|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive ‘yes’ responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||grams||Full Range|Median
1347746|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 4|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive ‘yes’ responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||grams||Full Range|Median
1347747|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant did not respond to air stimulation, 1 – participant responded to air stimulus but did not request discontinuation of stimulus, 2 – participant responded to air stimulus and requested discontinuation of stimulus, 3 – participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a Scale||Standard Deviation|Mean
1347748|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant did not respond to air stimulation, 1 – participant responded to air stimulus but did not request discontinuation of stimulus, 2 – participant responded to air stimulus and requested discontinuation of stimulus, 3 – participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1347775|NCT01831765|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects. For this endpoint baseline, and week 26 have been presented, where week 26 data is end of trial containing last available measurement. At baseline (week 0) 381, 382, 378 and 381, 382, 380 subjects at week 26 were analysed for faster aspart (meal), faster aspart (post) and Novorapid (meal) arms respectively.|||Kg||Standard Deviation|Mean
1347749|NCT01831791|Secondary|Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks|Blood samples for DHT analysis was collected at Baseline, Week 26 and Week 52. DHT values at a lower limit of quantification (LLQ) were imputed using 1/2 LLQ. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||nanomole per liter (nmol/L)||Standard Deviation|Mean
1347750|NCT01831791|Secondary|Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52|The DLQI is a 10-item validated measure developed specifically to assess quality of life (QoL) in participants with dermatological conditions. It assesses six domains: symptoms and feelings, daily activities, leisure, work ⁄school, personal relationships, and treatment. The DLQI total is the sum of 10 questions, each ranging from 0 (unanswered/not relevant,not at all) to 3 (very much). The higher the score, the greater the impairment of (QoL). Change from Baseline in DLQI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39, and Week 52|ITT Population|||Scores on a scale||Standard Deviation|Mean
1347751|NCT01831791|Secondary|Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52|The Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) questionnaire was used to assess participant-perceived problems in sexual function using 3 questions assessing problems with sex drive, erections and ejaculation. They are scored on a 5-point scale of 0 to 4 (0=big problem, 1= medium problem, 2=small problem, 3=very small problem, 4=no problem). Total scores range from 0-12. Change from Baseline in PAS SFI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39 and Week 52|ITT Population|||Scores on a scale||Standard Deviation|Mean
1347752|NCT01831791|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at 26 Weeks and 52 Weeks|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than Stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Screening (Baseline), Week 26, and Week 52. v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. The number of participants with stage changes from Baseline are summarized. The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study."|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Participants|||Number
1347753|NCT01831791|Secondary|Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 26 and Week 52 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline (Screening) with those subsequently obtained at Week 26 and Week 52. This assessment was made separately based on the global photography of the vertex and frontal views. The LOCF method for missing data was used for the assessment, if a participants was missing the Week 26 global photograph, but has a global photograph from an earlier assessment (i.e., a withdrawal visit), then that photograph was assessed during the panel review.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||Scores on a scale||Standard Deviation|Mean
1347754|NCT01831791|Secondary|Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Terminal hair count was based on the terminal hair(>=60 μm in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||Hair count||Standard Deviation|Mean
1347805|NCT01831258|Other Pre-specified|Apnea Hypopnea Index (AHI)|Collected through the device|2 weeks|Only 61 participant data was available.|||events/hour||Standard Error|Mean
1347806|NCT01831258|Other Pre-specified|Leak|The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device|One night|Obtained only 61 participant CPAP data.|||L/min||Standard Error|Mean
1347755|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Target area hair width was based on the total width of the nonvellus hairs(>=30μm in width) within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. The BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||microns x 10^-3||Standard Deviation|Mean
1347756|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52|Target area hair count is based on the nonvellus hair(>= 30 micrometer[μm] in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as post-BL value minus BL value. The BL value is defined as the latest assessment on or before the BL date(latest non-missing value of either treatment start date or randomization date). The last observation carried forward(LOCF) method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||Hair count||Standard Deviation|Mean
1347757|NCT01831791|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants answering yes/no responses to questions about suicidal ideation (Question [Que] 1 and Que 2) at Baseline and post-Baseline (since last visit) and suicidal behaviors (Que 6 – Que 10) at post-Baseline (since last visit) are presented. Questions included the presence (yes) or absence (no) of the following: Que 1 - a wish to be dead; Que 2 - nonspecific (NS) active suicidal thoughts; Que 6 - preparatory acts or behavior; Que 7 - aborted attempt; Que 8 - interrupted attempt (int. att.); Que 9 - non-fatal actual suicide attempt; Que 10 - completed suicide and non-suicidal self-injurious behavior. Final assessment (FA) is the last post-Baseline measurement during the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1347758|NCT01831791|Primary|Mean Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign monitoring included heart rate measurement at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in heart rate is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline visit, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Beats per minute||Standard Deviation|Mean
1347759|NCT01831791|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1347760|NCT01831791|Primary|Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline|Blood samples for the assessment of the indicated laboratory parameters were taken at the Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. The laboratory parameters included ALP, ALT, AST, total bilirubin, total protein, sodium, potassium, albumin, glucose, creatinine, urea/BUN, hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, and prostate-specific antigen (PSA). A laboratory value (LV) that is within the normal range is considered normal. A LV that is above the upper limit of the normal range is considered high abnormal. A LV that is below the lower limit of the normal range is considered low abnormal. Number of participants with any LV shifts from BL at any time post-BL are presented for, normal at BL to abnormal; normal at BL to high; normal at BL to low; normal or low at BL to high; normal or high at BL to low.|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only participants with a normal BL and at least one post-BL LV are analysed. ITT Population (represented by n=X in the category titles).|||Participants|||Number
1348619|NCT01818596|Secondary|Percent Change From Baseline in C-type Collagen Sequence (CTX) at Week 24|CTX is a biomarker of bone turnover.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
1347761|NCT01831791|Primary|Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points|Blood samples were collected for the measurement of prostate-specific antigen at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the prostate-specific antigen value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Microgram per liter (µg/L)||Standard Deviation|Mean
1347762|NCT01831791|Primary|Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for the measurement of potassium, sodium, glucose and urea/BUN at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the potassium, sodium, glucose and urea/BUN values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1347763|NCT01831791|Primary|Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the total bilirubin and creatinine values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1347764|NCT01831791|Primary|Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALT, ALP and AST at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the ALT, ALP and AST values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Units per liter (U/L)||Standard Deviation|Mean
1347765|NCT01831791|Primary|Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points|Blood samples were collected for the measurement of the red blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the red blood cell count value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1347766|NCT01831791|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points|Blood samples were collected for the measurement of platelet count and white blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the platelet count and white blood cell count values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
1347807|NCT01831258|Secondary|Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity|"Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference."|4 weeks|Data for 64 participant were available|||units on a scale||Standard Error|Mean
1347767|NCT01831791|Primary|Mean Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for the measurement of hematocrit at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hematocrit value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1347768|NCT01831791|Primary|Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for the measurement of hemoglobin, albumin and total protein at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hemoglobin, albumin and total protein values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1347769|NCT01831791|Primary|Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit|A qualitative breast examination was performed at Baseline (Week 0), at the Week 26 Visit and at the Week 52 Visit (and at the early withdrawal visit, if applicable). Participants were assessed for presence (reported as yes) and absence (reported as no) of palpable breast tissue (PBT) or nipple tenderness (NT) and/or clinically significant (CS) PBT or NT at Baseline (BL), at each scheduled Post-BL assessment. Change from BL in breast examination results included the number of participants with change from ‘no (N)’ at BL to ‘yes (Y)’ at any Post-BL assessment for the presence of PBT or NT, and the number of participants with change from N at BL in CS to Y at any Post-BL assessment in CS for PBT and for NT. BL value of an assessment is defined as the latest assessment on or before the BL date (latest non-missing value of either the treatment start date or the randomization date).|Baseline to Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1347770|NCT01831791|Primary|Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE)|An AE is considered drug-related if the relationship variable indicates so, or if the variable value is missing. Any AE with a start date on or after the treatment start date and on or before the last dose of treatment is considered on-treatment (treatment-emergent). This includes an AE with a missing onset date. Any AE which occurred, in the investigator’s judgement and is possibly related to suicidality, is defined as possible suicidality-related adverse event (PSRAE). Suicidality was assessed by using the columbia-suicide severity rating scale (C-SSRS) as determined by the investigator. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.|From Baseline (Week 0) until Week 52|ITT Population|||Participants|||Number
1347771|NCT01831791|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, drug-induced liver injury, breast cancer in male participants, prostate cancer, spontaneous abortion in female partner of male participants|From Baseline (Week 0) until Week 52|Intent-to-Treat (ITT) Population: comprised of all participants who received a randomization number, regardless of whether or not treatment was administered|||Participants|||Number
1347772|NCT01831765|Secondary|Change in PPG (Postprandial Glucose)|Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.|Week 0, week 52|The FAS included all randomised subjects. The number of subjects with data available for PPG at 120 mins at baseline were 379, 379 and 380, 380 at week 52 and for PPG increment (120 mins) at baseline were 379, 375 and 381, 380 at week 26 for faster aspart (meal) and Novorapid (meal) respectively.|||mmol/L||Standard Deviation|Mean
1347773|NCT01831765|Secondary|Change in HbA1c|Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.|Week 0, week 52|The FAS included all randomised subjects. The statistical evaluation of the FAS was to follow the ITT principle and subjects contributed to the evaluation ‘as randomised’. For this endpoint, baseline and week 52 have been presented, where week 52 data is the end of trial containing last available measurement.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1347774|NCT01831765|Secondary|Frequency of Adverse Events|All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment.|After 52 weeks of randomised treatment|The safety analysis set included all subjects receiving at least one dose of trial product/its comparator and contributed to the evaluation “as treated”. Five (5) subjects randomised to the faster aspart (post) group have consistently taken their bolus insulin before meals throughout the trial and are handled as treated with faster aspart (meal).|||event /100 patient yrs of exposure|||Number
1347776|NCT01831765|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.|From baseline until week 26|The safety analysis set included all subjects receiving at least one dose of trial product/its comparator and contributed to the evaluation “as treated”. Five (5) subjects randomised to the faster aspart (post) group have consistently taken their bolus insulin before meals throughout the trial and are handled as treated with faster aspart (meal).|||event rate/100 patient yrs of exposure|||Number
1347777|NCT01831765|Secondary|Change From Baseline in HbA1c (Post Meal Arm)|Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.|Week 0, week 26|This endpoint was summarised using the FAS, which included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1347778|NCT01831765|Secondary|Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)|Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).|Week 0, week 26|The FAS included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement. At baseline (week 0) 379, 377, 375 and 381, 382, 380 subjects at week 26 were analysed for faster aspart (meal), faster aspart (post) and Novorapid (meal) arms respectively.|||mmol/L||Standard Deviation|Mean
1347779|NCT01831765|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1347780|NCT01831726|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|36 months|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||months||95% Confidence Interval|Median
1347781|NCT01831726|Secondary|Progression-Free Survival (PFS)|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.|36 months|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||months||95% Confidence Interval|Median
1347782|NCT01831726|Secondary|Overall Response (OR) of Partial Response (PR) or Greater|Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR|Week 16|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||number of participants|||Number
1347783|NCT01831726|Primary|Clinical Benefit Rate (CBR)|CBR determined by investigator assessment for each tumor assessment & defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1|Week 16|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||number of participants|||Number
1347784|NCT01831466|Secondary|Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 8|FASm. Only observed data were analyzed.|||Percentage of Participants|||Number
1347785|NCT01831466|Secondary|Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 12|FASm. Only observed data were analyzed.|||Percentage of Participants|||Number
1347786|NCT01831466|Secondary|Change From Baseline to Week 8 in the DLQI Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 8|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
1347808|NCT01831258|Secondary|OSA Impact of Daily Life (Fatigue)|Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.|4 weeks|Data for 64 participant were available|||units on a scale||Standard Error|Mean
1347787|NCT01831466|Secondary|Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 12|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
1347788|NCT01831466|Secondary|Change From Baseline to Week 8 in Clinic-Based ISI Scores|The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their “worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “no itching” (0) and “worst possible itching” (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).|Baseline, Week 8|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
1347789|NCT01831466|Secondary|Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores|The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their “worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “no itching” (0) and “worst possible itching” (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).|Baseline, Week 12|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
1347790|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
1347791|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
1347792|NCT01831466|Secondary|Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347793|NCT01831466|Secondary|Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347794|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in PASI|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
1347795|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90–100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
1347809|NCT01831258|Secondary|OSA Impact of Daily Life|Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.|4 weeks|Data for 62 participant were available|||units on a scale||Standard Error|Mean
1347796|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347797|NCT01831466|Secondary|Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347798|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347799|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 12|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347800|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347801|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (erythema [E], induration [I], and scaling [S]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 12|The mild/moderate full analysis set (FASm) included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
1347802|NCT01831258|Secondary|Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change|"Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference."|4 weeks|Data for 64 participant were available|||units on a scale||Standard Error|Mean
1347803|NCT01831258|Post-Hoc|Adherence in Patients With Signs of Moderate Clinical Insomnia|Adherence from the device (during their entire study period) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)|8 weeks|Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.|||minutes||Standard Error|Mean
1347804|NCT01831258|Post-Hoc|Adherence in Patients With Signs of Moderate Clinical Insomnia|Adherence from the device (during their first treatment arm) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)|4 weeks|Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.|||minutes||Standard Error|Mean
1347810|NCT01831258|Secondary|Insomnia Severity Index (Subjective Sleep Quality)|Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).|4 weeks|Data for 63 participant were available|||units on a scale||Standard Error|Mean
1347811|NCT01831258|Secondary|Daytime Sleepiness (Subjective Sleep Quality)|Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.|4 weeks|Data for 65 participant were available|||units on a scale||Standard Error|Mean
1347812|NCT01831258|Primary|Adherence to CPAP Treatment|Average used minutes (all days) taken from the CPAP device.|2 weeks|Adherence data could only be obtained for 61 participants|||mins||Standard Error|Mean
1347813|NCT01831232|Secondary|Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)|Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR)|35 days|All patient who received IAP treatment were assessed for response. The number of participants with CR, CRi and PR are included in the table below.|||Participants|||Count of Participants
1347814|NCT01831232|Secondary|Number of Biomarker-positive Participants With Clinical Responses|"Biomarkers: FLT3-ITD positive, NPM1 positive, CEBPA. A good CR is defined as <5% blasts in the marrow by morphologic evaluation along with the absence of any MRD by flow cytometry or cytogenetics and recovery of blood counts (platelets >100,00 and absolute neutrophil count >1,000) by day 35 after induction. Cheson AML Response Criteria is used for Morphologic Leukemia Free State, Morphologic Complete Remission, Cytogenetic Complete Remission (CRc), Molecular Complete Remission (CRm), Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR), Treatment Failure, Recurrence (Progressive Disease)."|38 days after dosing|Participants with biomarkers: FLT3-ITD positive, NPM1 positive or CEBPA|||participants with clinical responses|||Number
1347815|NCT01831232|Secondary|Overall Survival|Amount of time a patient lives after treatment with IAP|1 year after treatment with IAP||||percentage of patients surviving||95% Confidence Interval|Number
1347816|NCT01831232|Secondary|Progression Free Survival (PFS)||1 year after treatment with IAP|Patients who had a good complete remission (CR), CR with evidence of minimal residual disease (MRD), or complete remission with incomplete blood count recovery (CRi) following treatment. Cheson AML Response Criteria are used to assess response.Good CR is defined as <5% blasts in marrow, no MRD and recovery of blood counts by day 35 after induction.|||percentage of patients with PFS||95% Confidence Interval|Number
1347817|NCT01831232|Primary|Number of Participants With TRM.|"A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.~TRM: Treatment Related Mortality"|28 days||||participants||95% Confidence Interval|Number
1347818|NCT01831232|Primary|Number of Participants With Good Complete Remission (CR)|"A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.~Definition of Good CR: Conventional criteria for CR (absolute neutrophil count > 1,000/uL, platelet count > 100,000/uL, marrow with <5% morphologic blasts) and additionally the requirements that marrow Minimal Residual Disease (MRD) - detected by 10-color flow cytometry or conventional cytogenetic evaluation - be absent and that the above blood counts be obtained."|35 days||||Participants|||Count of Participants
1347819|NCT01831219|Other Pre-specified|Number of Operated Hips That Required Revision/Reoperation|Implant survivorship will be determined from the medical history CRF by comparing the percentage of ROBODOC and manual control subjects who have required revision or re-operation THA procedures on the hip in question since their original study procedure which took place 7-20 years previously.|At follow-up visit (7-20 years post-operatively)||||Hips|Hips||Number
1347820|NCT01831219|Secondary|Visual Analog Pain Score|The Visual Analog Scale pain questionnaire will be used to measure clinical outcome. The pain VAS is a continuous scale which range from 0 (no pain) to 100 [100-mm scale] (“worst imaginable pain” ).|2 months||||units on a scale|Hips|Standard Deviation|Mean
1347821|NCT01831219|Secondary|UCLA Activity Score|The UCLA Activity Score will be used to measure clinical outcome. The UCLA Activity Score ranges 10 (best) to 0 (worst).|2 months||||units on a scale|Hips|Standard Deviation|Mean
1347822|NCT01831219|Secondary|Health Status Questionnaire-12|The Health Status Questionnaire-12 (HSQ-12) will be used to measure clinical outcome. HSQ-12 total score ranges from 0 (worst) to 800 (best).|2 months||||units on a scale|Hips|Standard Deviation|Mean
1347823|NCT01831219|Secondary|Harris Hip Score|The Harris Hip Score will be measured to determine clinical outcome. The Harris Hip total score ranges 100 (best) to 0 (worst) and it is computed by the sum of the pain score (0–44 points), function (, 0–47 points), absence of deformity (4 points), and range of motion (5 points).|2 months||||units on a scale|Hips|Standard Deviation|Mean
1347824|NCT01831219|Primary|Western Ontario and McMaster Universities Osteoarthritis Index|The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome. The WOMAC total score ranges 96 (best) to 0 (worst). The WOMAC pain score ranges 0–20, the stiffness score ranges 0–8, and functional limitation score ranges 0–68.|2 months||||units on a scale|Hips|Standard Deviation|Mean
1347825|NCT01831219|Primary|Presence of Osteolysis|Presence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.|14 months||||Hips|Hips||Number
1347844|NCT01830920|Secondary|Duration of AKI|AKI is defined using the Scr-KDIGO criteria. Duration of AKI is defined as the number of days from start of AKI (SCr-KDIGO) where either SCr increase ≥ 0.3 mg/dL above pre-AKI reference point (if the value exists) or if SCr increase ≥1.5 times baseline or dialysis in the first 7 days up to discharge if prior to 7 days.|7 days OR up to discharge after surgery|Per Protocol Analysis set|||days||Standard Deviation|Mean
1348636|NCT01818141|Primary|C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool|The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).|day 10-13||||Participants|||Count of Participants
1347826|NCT01831154|Secondary|Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.|Intraoperative glycemic stability was operationalize as how often blood glucose levels were maintained as normal or maintained in the preset target ranges for each group. If intraoperative blood glucose levels fell outside of normal (hypoglycemia or hyperglycemia) or, outside the preset target ranges, for each protocol, for 3 consecutive blood glucoses (1.5 hours) despite insulin therapy a marker of inadequate glycemic control was recorded.|Measures of blood glucose every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes whichever event occurred first|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. No data analysis could be performed because there were too few episodes of glycemic instability.|||episodes out of target glucose range|||Number
1347827|NCT01831154|Secondary|The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery|Length of stay (LOS) in the intensive care unit was measured by the total number of days each patient stayed in the intensive care unit.|ICU days measured every day the patient stayed in ICU starting with entry into the ICU from the Operating Room until discharge from the ICU to the ward|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.|||days||Standard Deviation|Mean
1347828|NCT01831154|Secondary|Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery|Blood glucose values were obtained every 30 minutes in the intraoperative period, and were drawn and recorded by the certified registered nurse anesthetist (CRNA) performing the anesthetic. Repeated measured ANOVA with Greenhouse-Geisser correction was employed to determine if participants assigned to the tight glycemic group yielded lower blood glucose levels intraoperatively (every 30 minutes for 240 minutes) than the other two interventions. All blood glucose measures over the intraoperative period were averaged to produce a mean and standard deviation comparing the tight glycemic group to the other two interventional groups, Data points were blood glucose testing collected every 30 minutes starting on entry into the operating room.|Blood glucose measured every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes, whichever event occurred first|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.|||mg/dl||Standard Deviation|Mean
1347829|NCT01831154|Primary|The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery|C-Reactive Protein concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All C-Reactive Protein blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean C-Reactive Protein values with standard deviation.|Post cardiopulmonary bypass and postoperative day 1 through 5|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. Six participants had > 50% missing data and were dropped from this analysis (4 tight, 1 in other two groups).|||Mg/L||Standard Deviation|Mean
1347830|NCT01831154|Primary|The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery|Procalcitonin concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All procalcitonin blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean procalcitonin values with standard deviation.|Post CPB and Postoperative days 1 through 5|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. Six participants had > 50% missing data and were dropped from this analysis (4 tight, 1 in other two groups).|||ng/ml||Standard Deviation|Mean
1347831|NCT01831154|Primary|Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection|The presence or absence of deep, or/and superficial sternal wound infection and deep, superficial harvest site infection within in six weeks postoperatively was a primary outcome variable. Infection assessment was performed during the intensive care phase, at hospital discharge, two-week post hospital discharge and six-week post hospital discharge by independent blinded researchers that were part of the cardiothoracic team.|six weeks postoperatively|Inclusion > age 21, underwent elective or urgent Coronary Artery Bypass Graft (CABG) with or without combined valve surgery or valve surgery alone, on or off cardiopulmonary bypass (CPB). Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.|||participants|||Number
1347832|NCT01830972|Primary|Interval History: Typical Number of Falls Per Year|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 6, 12, 18, 24, 30, 36, study termination|All participants who received at least one dose of study drug. Naïve Participants did not enter the study until Part II.|||falls||Standard Deviation|Mean
1347883|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347833|NCT01830972|Primary|Interval History: Has the Participant Started Receiving Any New Therapy or Discontinued Any Therapies Since Last Study Visit?|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 33, 36, study termination|All participants who received at least one dose of study drug. Participant “n” at each time point includes those with a yes or no response. Naïve Participants did not enter the study until Part II.|||Participants|||Count of Participants
1347834|NCT01830972|Primary|Interval History: Has the Participant Started Taking Any New Medications or Discontinued Any Medications Since the Study Visit?|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 33, 36, study termination|All participants who received at least one dose of study drug. Participant “n” at each time point includes those with a yes or no response. Naïve Participants did not enter the study until Part II.|||Participants|||Count of Participants
1347835|NCT01830972|Primary|Interval History: Has the Participant Experienced Any New Conditions or Exacerbations of an Existing Condition Since Last Study Visit?|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 33, 36, study termination|All participants who received at least one dose of study drug. Participant “n” at each time point includes those with a yes or no response. Naïve Participants did not enter the study until Part II.|||Participants|||Count of Participants
1347836|NCT01830972|Primary|Clinically Significant Changes From Baseline in Vital Signs, Physical and Neurological Examination Findings and Laboratory Evaluations||From first dose of study drug until up to 30 days after the last dose of study drug. Mean (SD) duration of treatment was 1170.0 (170.2) days for Crossover Participants and 897 (380) days for Naïve Participants|Clinically significant changes from Baseline for vital signs, physical and neurological examination findings and laboratory evaluations were recorded as AEs and are reported as part of the Safety section of this record and Outcome Measure 1.||||||
1347837|NCT01830972|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An adverse event (AE) is defined as any untoward medical occurrence, whether or not considered drug related. A serious AE (SAE) is an AE that at any dose results in any of the following: death, a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect. TEAEs include all adverse events that start on or after the first dose of study medication, or adverse events that are present prior to the first dose of study medication, but their severity or relationship increases after the first dose of study medication up to and including 30 days after the final study medication dosing date. TEAEs were graded as mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5). TEAE relationship to study medication was classified as not related, possibly related, or probably related.|From first dose of study drug until up to 30 days after the last dose of study drug. Mean (SD) duration of treatment was 1170.0 (170.2) days for Crossover Participants and 897 (380) days for Naïve Participants|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
1347838|NCT01830933|Primary|Percentage of Participants Who Reported Discussion of Mammography Screening|Self reported discussion of mammography with physician.|up to 14 months||||percentage of participants|||Number
1347839|NCT01830933|Primary|Percentage of Participants Who Had a Discussion of Breast Cancer Risk|Self-reported discussion of breast cancer risk with physicians.|one week post-initial visit (approximately one week)||||percentage of participants|||Number
1347840|NCT01830933|Primary|Percentage of Participants With Correct Perception of Risk|This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.|baseline, one week post-initial visit (approximately one week)||||percentage of participants|||Number
1347841|NCT01830933|Primary|Knowledge of Breast Cancer Risk Factors|Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O|one week post-initial visit (approximately one week)||||units on a scale||Standard Deviation|Mean
1347842|NCT01830920|Other Pre-specified|Composite of Death, Dialysis, or Sustained Impaired Renal Function|Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.|Day 30|Per Protocol Analysis set|||Participants|||Count of Participants
1347843|NCT01830920|Other Pre-specified|Composite of Death, Dialysis, or Sustained Impaired Renal Function|Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.|Day 30|Per Protocol Analysis set|||Participants|||Count of Participants
1347884|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination||Within 30 Days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347845|NCT01830920|Secondary|Severity of AKI|"AKI is defined using the KDIGO criteria, in which AKI is defined as any of the following:~Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or~Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or~Urine volume <0.5 ml/kg/h for 6 hours.~Staging of AKI is defined as the following:~Stage 1: SCr 1.5 - 1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase, Urine output <0.5 ml/kg/hr for 6-12 hours Stage 2: SCr 2.0-2.9 times baseline, Urine output <0.5 ml/kg/h for ≥ 12 hours Stage 3: SCr 3.0 times baseline OR Increase in SCr to ≥5.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy OR In patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m^2, Urine output <0.3 ml/kg/h for ≥24 hours OR Anuria for ≥12 hours.~No AKI is considered the best outcome, and Stage 3 the worst outcome."|7 days|Per Protocol Analysis set|||Participants|||Count of Participants
1347846|NCT01830920|Secondary|Incidence of AKI|"AKI is defined using the SCr-KDIGO criteria, defined as the following:~Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or~Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days."|7 days|Per Protocol Analysis set|||Participants|||Count of Participants
1347847|NCT01830920|Primary|Incidence of Acute Kidney Injury (AKI)|"Acute kidney injury (AKI) is defined using the KDIGO criteria, in which AKI is defined as any of the following:~Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or~Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or~Urine volume <0.5 ml/kg/h for 6 hours."|7 days|Per Protocol Analysis set -|||Participants|||Count of Participants
1347848|NCT01830881|Secondary|Number of Participants With Need for Additional Postoperative Pain Medication|Subjects will be assessed 30 minutes postoperatively for need of additional pain medications.|30 minutes postoperatively|One participant in the Midazolam group left the study. One participant in the placebo group decided not to have the procedure.|||Participants|||Count of Participants
1347849|NCT01830881|Secondary|Subject Sleepiness 30 Minutes Postprocedure|Subject sleepiness will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable|30 minutes postoperatively||||units on a scale||Standard Deviation|Mean
1347850|NCT01830881|Secondary|Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure|Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively|30 minutes postoperatively||||percent saturation||Standard Deviation|Mean
1347851|NCT01830881|Secondary|Subject Vital Signs (Oxygenation Saturation)|Subject oxygenation status will be assessed for the duration of the procedure|intraoperatively (30-60 minutes after premedication)||||percent saturation||Standard Deviation|Mean
1347852|NCT01830881|Secondary|Subject's Correct Identification of Receiving Midazolam or Placebo|Number of patient's who could correctly determine if they received study drug or placebo when asked|30 minutes postoperatively||||Participants|||Count of Participants
1347853|NCT01830881|Secondary|Subject Nausea 30 Minutes Postprocedure|Subject nausea will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable|30 minutes postoperatively||||100-mm visual analog sclae for nausea||Full Range|Mean
1347854|NCT01830881|Secondary|Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure|Subject vital signs (heart rate) will be assessed 30 minutes postoperatively|30 minutes postoperatively|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||bpm||Standard Deviation|Mean
1347855|NCT01830881|Secondary|Subject Vital Signs (Heart Rate)|Subject heart rate will be assessed for the duration of the procedure|intraoperatively (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||bmp||Full Range|Mean
1347856|NCT01830881|Secondary|Subject Extent of Sedation|Subject extent of sedation 30-60 minutes after premedication, just prior to procedure as measured by the 6-point Ramsay Scale (1 = patient anxious agitated, or restless; 2 = patient cooperative, oriented, and tranquil; 3 = patient asleep, responds to commands only; 4 = patient asleep, responds to gentle shaking, light glabellar tap, or loud auditory stimulus; 5 = patient asleep, responds to noxious stimuli such as firm nail bed pressure; 6 = patient asleep, has no response to firm nail bed pressure or other noxious stimuli)|30-60 minutes after premedication|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||Participants|||Count of Participants
1347857|NCT01830881|Secondary|Subject Extent of Amnesia|To assess the extent of amnesia 1-3 days postoperatively as measured by 100mm Visual Analog Scale with 0mm being Remember Nothing and 100mm being Remember Everything.|1-3 days postoperatively||||mm||Standard Deviation|Mean
1347858|NCT01830881|Secondary|Subject Extent of Amnesia Using Amnesia Score|To assess the extent of amnesia 30 min postoperatively as measured by ability to recall procedure using 4-point scale (0 = unable to recall any proportion of the procedure, 1 = able to recall and describe some portions of the procedure, but overall has minimal recall of the procedure, 2 = able to recall and describe most of the procedure, but admits to inability to recall some portion of the procedure, 3 = able to recall and describe the entire procedure).|30 minutes postoperatively||||Participants|||Count of Participants
1347859|NCT01830881|Secondary|Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure|To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 1-3 days postoperatively as measured by a mm VAS with 0mm being Not At All Satisfied and 100mm being Very Satisfied|1-3 days post-operatively||||mm on a 100 mm Visual Analog Scale||Standard Deviation|Mean
1347860|NCT01830881|Secondary|Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively|To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 30 min postoperatively as measured by a mm Visual Analog Scale with 0mm being Not At All Satisfied and 100mm being Very Satisfied|30 minutes post-operatively||||mm on a 100 mm Visual Analog Scale||Standard Deviation|Mean
1348637|NCT01818063|Secondary|Relapse Free Survival|Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.|Up to 3 years||2019-04-30|04/2019||||
1347861|NCT01830881|Secondary|State-Trait Anxiety Inventory for Anxiety at Baseline|To measure the mean State-Trait Anxiety Inventory (STAI) Form Y-1 for anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” Each type of anxiety has its own 4-point scale of 20 different questions that are scored. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always. Scores range from 20 to 80, with higher scores indicate greater anxiety. State anxiety items and Trait anxiety items were each summed in assessment to provide two total scores for each participant, a State anxiety score and a Trait anxiety score. Mean and standard deviation of total scores for each group are reported.|Baseline (upon entry into study)||||units on a scale||Standard Deviation|Mean
1347862|NCT01830881|Secondary|Subject Perception of Pain During Cervical Dilation|Subjects will be asked to rate pain at the time of cervical dilation by marking along a mm Visual Analog Scale, with 0mm being No Pain and 100mm being Worst Imaginable Pain|with cervical dilation (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
1347863|NCT01830881|Secondary|Subject Perception of Anxiety With Patient Positioning Procedure|Subjects will be asked to rate anxiety prior to starting pelvic exam by marking along a mm Visual Analog Scale, with 0mm being No Anxiety and 100mm being Worst Imaginable Anxiety|prior to starting pelvic exam (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
1347864|NCT01830881|Secondary|Subject Perception of Pain and Anxiety Post Procedure|Subjects will be asked to rate anxiety and pain 30 minutes post-operatively by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|30 minutes post operatively|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
1347865|NCT01830881|Secondary|Subject Perception of Pain and Anxiety Upon Entering Procedure Room|Subjects will be asked to rate anxiety and pain upon entering procedure room by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|upon entering procedure room (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
1347866|NCT01830881|Secondary|Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline|Subjects will be asked to rate their anticipated anxiety and pain at the time of uterine aspiration by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|Baseline (upon entry into study)||||mm||Standard Deviation|Mean
1347867|NCT01830881|Primary|Subject Perception of Pain and Anxiety During Uterine Aspiration|Subjects will be asked to rate anxiety and pain at the time of uterine aspiration by marking along a 100 mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|at time of uterine aspiration (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
1347868|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination (Vac)|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
1347869|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.||||||
1347870|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary outcome measure ‘Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
1347871|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
1347872|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination||Before vaccination (Vac) 1, 1 Month after Vac 2|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||titer||95% Confidence Interval|Geometric Mean
1347915|NCT01830855|Primary|hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain.|||titer||95% Confidence Interval|Geometric Mean
1347873|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination||One month after second, third vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.|||percentage of participants||95% Confidence Interval|Number
1347874|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.|||percentage of participants||95% Confidence Interval|Number
1347875|NCT01830855|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point.|||percentage of participants||95% Confidence Interval|Number
1347876|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain.|||titer||95% Confidence Interval|Geometric Mean
1347877|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
1347878|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
1347879|NCT01830855|Primary|Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
1347880|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
1347881|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
1347882|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
1347885|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
1347886|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
1347887|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
1347888|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available.|||percentage of participants||95% Confidence Interval|Number
1347889|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.|||percentage of participants||95% Confidence Interval|Number
1347890|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347891|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 Days After any Vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347892|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
1347893|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
1347894|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
1347895|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347896|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.|||percentage of participants||95% Confidence Interval|Number
1347897|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347898|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347899|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
1347900|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
1347901|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
1347902|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347903|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.|||percentage of participants||95% Confidence Interval|Number
1347904|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347905|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
1347906|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
1347907|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
1347908|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
1347909|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, number of participants analyzed signifies participants with known values after third vaccination.|||percentage of participants||95% Confidence Interval|Number
1347910|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.|||percentage of participants||95% Confidence Interval|Number
1347911|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.Here,number of participants analyzed signifies participants with known values after the first vaccination.|||percentage of participants||95% Confidence Interval|Number
1347912|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.Here,number of participants analyzed signifies participants with known values after third vaccination.|||percentage of participants||95% Confidence Interval|Number
1347913|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.|||percentage of participants||95% Confidence Interval|Number
1347914|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination. Here,number of participants analyzed signifies participants with known values after the first vaccination.|||percentage of participants||95% Confidence Interval|Number
1347916|NCT01830855|Primary|Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1347917|NCT01830842|Primary|Change in Blood Oxygen Level Dependent (BOLD) Signal in Dorsomedial Prefrontal Cortex|The acute and chronic effects of nicotine on the blood oxygen level dependent signal will be measured using functional magnetic resonance imaging. Reward-cue related BOLD signal on an outcome expectation task.|Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety|Subjects who did not follow MRI task instructions, or those with > 3 mm of movement, were excluded from the analyses.|||percentage of BOLD signal||Standard Deviation|Mean
1347918|NCT01830790|Secondary|Change in Central Foveal Thickness as Assessed by Optical Coherence Tomography (OCT)||Baseline, 1hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.||||||
1347919|NCT01830790|Primary|Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT)||Baseline, 1 hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.||||||
1347920|NCT01830699|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.|4 weeks||||participants|||Number
1347921|NCT01830699|Secondary|Improvement in Pain|Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).|4 weeks||||units on a scale||Standard Deviation|Mean
1347922|NCT01830699|Primary|Improvement in Shoulder Function|The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: < 15 = no problem, 16 - 40 = problem, but working, > 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.|4 weeks||||units on a scale||Standard Deviation|Mean
1347923|NCT01830543|Secondary|Percentage of Participants With Stent Thrombosis|The percentage of participants with the first occurrence of stent thrombosis were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1347924|NCT01830543|Secondary|Percentage of Participants With Stroke|The percentage of participants with the first occurrence of Stroke were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1347925|NCT01830543|Secondary|Percentage of Participants With Myocardial Infarction|The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1347926|NCT01830543|Secondary|Percentage of Participants With Cardiovascular Death|The percentage of participants with the first occurrence of cardiovascular death were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1347927|NCT01830543|Secondary|Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)|Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1347928|NCT01830543|Secondary|Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)|A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1348670|NCT01817777|Secondary|Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days|The number of days on which no metformin pills were taken by participants was summarized.|Week 28|Per Protocol Population|||Participants|||Number
1347929|NCT01830543|Secondary|Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding|TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1347930|NCT01830543|Secondary|Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
1347931|NCT01830543|Primary|Percentage of Participants With Clinically Significant Bleeding|Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.|Up to Month 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1347932|NCT01830205|Secondary|Number of Participants With Out-of-range Vital Signs Reported as Adverse Events|The total number of participants with abnormal range vital signs which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.|||Participants|||Number
1347933|NCT01830205|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events|The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.|||Participants|||Number
1347934|NCT01830205|Secondary|Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events|Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.|Baseline up to Day 5 post dose|The analysis was done in safety population.|||Participants|||Number
1347935|NCT01830205|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died|Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs|Analysis was done in safety data set population, defined as all the participants who received the study medication.|||Participants|||Number
1347936|NCT01830205|Secondary|Apparent Volume of Distribution (Vd/F) of Daclatasvir|The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1347937|NCT01830205|Secondary|Renal Clearance (CLR) of Daclatasvir|The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1347938|NCT01830205|Secondary|Percent Urinary Recovery (%UR) of Daclatasvir|The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.|||Percentage of daclatasvir recovered||Geometric Coefficient of Variation|Geometric Mean
1347939|NCT01830205|Secondary|Unbound Apparent Clearance (CLU/F) of Daclatasvir|The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1347940|NCT01830205|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir|Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1347941|NCT01830205|Secondary|Plasma Half-life (T-half) of Daclatasvir|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||hours||Geometric Coefficient of Variation|Geometric Mean
1347942|NCT01830205|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||hours||Full Range|Median
1347943|NCT01830205|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir|AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
1347944|NCT01830205|Secondary|Unbound Maximum Observed Plasma Concentrations of Daclatasvir|Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347945|NCT01830205|Secondary|Maximum Observed Plasma Concentration (Cmax) of Daclatasvir|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1347946|NCT01830205|Secondary|Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir|AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1347947|NCT01830205|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir|AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|PK data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on the C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1347948|NCT01830140|Primary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
1347949|NCT01830127|Secondary|SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.|4 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.|||Percentage of participants||95% Confidence Interval|Number
1347950|NCT01830127|Primary|SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.|12 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.|||Percentage of participants||95% Confidence Interval|Number
1347951|NCT01829919|Primary|Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"C(t) is the measured plasma level Concentration of the drug at time = t expressed as nanograms per milliliter."|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
1347952|NCT01829919|Primary|Cavg,ss (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
1347953|NCT01829919|Primary|Fluctuation Index (%) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Fluctuation Index is (Cmax-Cmin)/Cavg,ss. It is peak trough fluctuation within one dosing interval at steady state.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Percentage of steady state concentration||Full Range|Mean
1347954|NCT01829919|Primary|Accumulation Index Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg at Day 19|Accumulation Index is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. In this case the steady state Accumulation Index was calculated at Day 19. Accumulation Index is calculated at the end of the dosing period.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Ratio||Full Range|Mean
1347955|NCT01829919|Primary|Tmax (Hour) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hours||Full Range|Mean
1347956|NCT01829919|Primary|Cmin (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
1347957|NCT01829919|Primary|Cmax (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
1347958|NCT01829919|Primary|AUC (Hour*ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hour*ng/mL||Standard Deviation|Mean
1347959|NCT01829919|Primary|Median t1/2 Single Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||hours||Full Range|Median
1347960|NCT01829919|Primary|Mean t1/2 Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hours||Standard Deviation|Mean
1347961|NCT01829919|Primary|Kel (Hour^-1) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hour^(-1)||Standard Deviation|Mean
1347962|NCT01829919|Primary|Cmax (ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
1347963|NCT01829919|Primary|AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hour*ng/mL||Standard Deviation|Mean
1347964|NCT01829711|Secondary|Percentage of Participants With OR by Investigator’s Assessment|The OR was defined as number of participants with a best response of CR or PR. CR requires all of following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>=2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either <17 cm or have decreased by >25% from its baseline); normal CBC (Neutrophils >=1.5 x 10^9/L, Platelets >=100 x 10^9/L, and hemoglobin >=11.0 g/dL) without transfusions or growth factors for at least 4 weeks. PR requires all of following for a period of at least 4 weeks: >=50% decrease or normalization (<5.0 x 10^9/L) in peripheral blood lymphocyte count and >=50% reduction in lymphadenopathy and in abnormal haepatosplenomegaly by CT or MRI from pre-treatment baseline value; normal CBC as mentioned above or 50% improvement in CBC values over baseline without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, end of treatment, and at follow-up visits every 3 months for the next 24 months and every 6 months thereafter (Approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
1347965|NCT01829711|Secondary|Percentage of Participants With MRD Positive or MRD Negative CR by Investigator’s Assessment|"The CR with Positive or Negative MRD requires all of the following to be present:~No evidence of leukemic cells in the peripheral blood and/or by routine H/E staining of bone marrow. Minimal Residual Disease: CR with HCL evident in blood or marrow by flow cytometry.~Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI. Although a normal spleen size is not defined, the maximum diameter of the spleen should be either < 17 cm or have decreased by >25% from its baseline.~Normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks."|Prior to each treatment cycle, end of treatment, and at follow-up visits every 3 months for the next 24 months and every 6 months thereafter (Approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
1348010|NCT01829464|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1347966|NCT01829711|Secondary|Percentage of Participants With Positive Anti-drug Antibodies (ADA), Neutralizing Anti-drug Antibodies (nAb) and Specificity (CD22 and PE38) Positive to Moxetumomab Pasudotox|Participants with ADA positive, nAb positive, cluster of differentiation 22 (CD22) positive of ADA positive/NAb positive, and pseudomonas exotoxin 38 (PE38) positive of ADA positive/NAb positive to moxetumomab pasudotox at any visit are reported.|Pre-infusion on Day 1 of Cycles 1, 2, 3, and 5; at the End of Treatment (4 to 6 weeks after the last dose; approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Percentage of Participants|||Number
1347967|NCT01829711|Secondary|Terminal Half Life (t1/2) of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable subjects for the calculation of the concerned parameters (ie., data were not sufficient).|||Hours||Standard Deviation|Mean
1347968|NCT01829711|Secondary|Systemic Clearance (CL) of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable subjects for the calculation of the concerned parameters (ie., data were not sufficient).|||mL/hr/kg||Standard Deviation|Mean
1347969|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve Extrapolated (AUCExt) of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng*hr/mL||Standard Deviation|Mean
1347970|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable subjects for the calculation of the concerned parameters (ie., data were not sufficient).|||ng*hr/mL||Standard Deviation|Mean
1347971|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 3 Hours (AUC0-3hr) Post End of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, and 3 hr post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng*hr/mL||Standard Deviation|Mean
1347972|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-last) of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng*hr/mL||Standard Deviation|Mean
1347973|NCT01829711|Secondary|Time of Last (Tlast) Measurable Concentration of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||Hours||Standard Deviation|Mean
1347974|NCT01829711|Secondary|Maximum Observed Plasma Concentration (Cmax) of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng/mL||Standard Deviation|Mean
1347975|NCT01829711|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox||Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|Pharmacokinetic (PK) population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||Hours||Full Range|Median
1347976|NCT01829711|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs|An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
1347977|NCT01829711|Secondary|Number of Participants With Abnormal Vital Signs Reported as TEAEs|An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
1348697|NCT01817491|Primary|Change in hsCRP (High-sensitivity C-reactive Protein)||baseline, 4 weeks|Children and Parents|||mg/L||Standard Deviation|Mean
1348698|NCT01817491|Primary|Change in Glucose||baseline, 4 weeks|Children and Parents|||mg/dL||Standard Deviation|Mean
1347978|NCT01829711|Secondary|Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
1347979|NCT01829711|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug.|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
1347980|NCT01829711|Secondary|Time to Treatment Failure (TTF) Assessed by Blinded Independent Central Review|The TTF was defined as the time from the start of moxetumomab pasudotox administration to the date of the first of relapse, progressive disease, initiation of alternative anticancer therapy, or death due to disease or disease-related complication. The TTF was censored on the date of last disease assessment or hematologic assessment for participants who are alive with no documented relapse or PD prior to data cut-off, dropout, or the initiation of alternative anticancer therapy and also censored for death not accompanied by relapse.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Months||95% Confidence Interval|Median
1347981|NCT01829711|Secondary|Progression-free Survival (PFS) Assessed by Blinded Independent Central Review|The PFS was defined as the time from the start of moxetumomab pasudotox administration to the earliest date of a disease assessment showing a progressive disease/relapse, earliest date of hematologic relapse or date of death, whichever was earlier. The PFS was censored on the date of last disease assessment or hematologic assessment for participants who are alive with no documented relapse or PD prior to data cut-off, dropout, or the initiation of alternative anticancer therapy.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Months||95% Confidence Interval|Median
1347982|NCT01829711|Secondary|Duration of Objective Response Assessed by Blinded Independent Central Review|"Duration of OR was defined as the time from the first documentation of objective response (CR or PR) to the date of relapse.~Duration of OR was censored on the date of last disease assessment or hematologic assessment for participants who have no documented relapse prior to data cut-off, dropout, or the initiation of alternative anticancer therapy."|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Duration of OR was evaluated for participants who achieved OR.|||Months||95% Confidence Interval|Median
1347983|NCT01829711|Secondary|Time to Objective Response Assessed by Blinded Independent Central Review|Time to OR was defined as the time from the start of moxetumomab pasudotox administration to the first documentation of OR (CR or PR).|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Time to OR was evaluated for participants who achieved OR.|||Months||Full Range|Median
1347984|NCT01829711|Secondary|Percentage of Participants With Objective Response (OR) Assessed by Blinded Independent Central Review|The OR was defined as number of participants with a best response of CR or PR. CR requires all of following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>=2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either <17 cm or have decreased by >25% from its baseline); normal CBC (Neutrophils >=1.5 x 10^9/L, Platelets >=100 x 10^9/L, and hemoglobin >=11.0 g/dL) without transfusions or growth factors for at least 4 weeks. PR requires all of following for a period of at least 4 weeks: >=50% decrease or normalization (<5.0 x 10^9/L) in peripheral blood lymphocyte count and >=50% reduction in lymphadenopathy and in abnormal haepatosplenomegaly by CT or MRI from pre-treatment baseline value; normal CBC as mentioned above or 50% improvement in CBC values over baseline without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
1348007|NCT01829477|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|In accordance with the Statistical Analysis Plan (SAP), due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
1347985|NCT01829711|Secondary|Time to Hematologic Remission|Time to HR was defined as the time from the start of moxetumomab pasudotox administration to the first documentation of HR. HR was defined as the blood counts required for CR as normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Time to HR was evaluated for participants in the ITT population who achieved HR.|||Months||Full Range|Median
1347986|NCT01829711|Secondary|Duration of Hematologic Remission (HR)|"Duration of HR was defined as the duration from documentation of HR to the time of relapse. HR was defined as the blood counts required for CR as normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.~Duration of HR was censored on the date of the last hematologic assessment for participants who have no documented relapse based on blood count prior to data cutoff, dropout, or initiation of alternative anticancer therapy."|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Duration of HR was evaluated for participants who achieved HR.|||Months||95% Confidence Interval|Median
1347987|NCT01829711|Secondary|Duration of CR Assessed by Blinded Independent Central Review|Duration of CR was defined as the duration from documentation of CR to the time of relapse from CR. Relapse from CR was defined as any CR criteria (blood counts, imaging or bone marrow) no longer consistent with CR. CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either < 17 cm or have decreased by >25% from its baseline); normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Duration of CR was evaluated for participants who achieved CR.|||Months||95% Confidence Interval|Median
1347988|NCT01829711|Secondary|Time to CR Assessed by Blinded Independent Central Review|Time to CR was defined as the time from the start of moxetumomab pasudotox administration to the first documentation of CR.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Time to CR was evaluated for participants who achieved CR.|||Months||Full Range|Median
1347989|NCT01829711|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Positive or MRD Negative CR Assessed by Blinded Independent Central Review|"The CR with Positive or Negative MRD requires all of the following to be present:~No evidence of leukemic cells in the peripheral blood and/or by routine H/E staining of bone marrow. Minimal Residual Disease: CR with HCL evident in blood or in bone marrow biopsy by immunohistochemistry.~Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI. Although a normal spleen size is not defined, the maximum diameter of the spleen should be either < 17 cm or have decreased by >25% from its baseline.~Normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks."|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
1347990|NCT01829711|Primary|Percentage of Participants With Durable Complete Response (CR) Assessed by Blinded Independent Central Review|Durable CR was defined as overall response that meets blood, bone marrow and imaging criteria for complete response (CR), followed by a >180 day duration of hematologic remission (HR). CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either < 17 cm or have decreased by >25% from its baseline.); HR requires normal complete blood count (CBC) as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.|Full disease assessment (CBC, bone marrow and imaging) at end of treatment (EOT; up to 24 weeks) and post EOT Day 181; CBC monthly for 6 months post EOT, every 3 months post Day 181 for first 2 years and every 6 months thereafter (approximately 4 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
1347991|NCT01829516|Secondary|Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.|We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated.|Administered at visits 2 and 3|1 subject did not complete the RMET task, so only 31 participant responses were analyzed for this task.|||Mean percent correct responses||Standard Error|Mean
1348699|NCT01817491|Primary|Change in Lipid Profile||baseline, 4 weeks|Children and Parents|||mg/dL||Standard Deviation|Mean
1347992|NCT01829516|Primary|Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.|Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.|Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.|In this crossover study a total of 32 participants were analyzed for each intervention.|||units on a 7-pt Likert Scale||Standard Error|Mean
1347993|NCT01829503|Secondary|Quality of Life|Patient reported symptoms and quality of life, as well as objective indicators of sleep, will be examined with quantitative summaries, followed by analyses with GLM approaches, whether or not the participant completed all cycles of therapy, or all assessments. Exploratory analyses will examine effects of the chemotherapy regimen on multiple symptoms. Explanatory variables will include covariate (e.g., age) and mediator variables (e.g., expectations) across cycles of chemotherapy.|Up to 5 years||2017-10-31|10/2017||||
1347994|NCT01829503|Secondary|Relapse-Free Survival in Participants With Complete Response, Complete Response With Incomplete Count Recovery or Partial Response, and Received Maintenance Therapy||Up to 38 months|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response.|||months||90% Confidence Interval|Median
1347995|NCT01829503|Secondary|Relapse-Free Survival in Participants With Complete Response or Complete Response With Incomplete Count Recovery.||Up to 38 months|Evaluable participants who experienced a Clinical Response (CR) of Complete Response or Complete Response with Incomplete Count Recovery.|||months||90% Confidence Interval|Median
1347996|NCT01829503|Secondary|Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)|Median number of months of survival per individual demographic characteristics and clinical measures.|Up to 38 months (median follow-up = 25.4 months)|All study participants.|||months||95% Confidence Interval|Median
1347997|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response, Complete Response With Incomplete Count Recovery, or Partial Response||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or, Partial Response.|||months||90% Confidence Interval|Median
1347998|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response or Complete Response With Incomplete Count Recovery||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, or Complete Response with Incomplete Count Recovery.|||months||90% Confidence Interval|Median
1347999|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response.|||months||90% Confidence Interval|Median
1348000|NCT01829503|Secondary|Overall Survival (OS)||Up to 38 months (median follow-up = 25.4 months)|All study participants.|||months||90% Confidence Interval|Median
1348001|NCT01829503|Secondary|Proportion of Participants With Survival to Four and Eight Weeks and One Year|The proportion of all participants experiencing four and eight-week mortality, or, who were alive at one year.|Up to one year (4 weeks, 8 weeks, and one year)|All study participants.|||Proportion of participants||90% Confidence Interval|Number
1348002|NCT01829503|Secondary|Numbers of Patients (Out of 44) Experiencing Adverse Events With CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4|The number of participants (out of 44) experiencing adverse events, with CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4|Up to 38 months|All study participants.|||Participants|||Number
1348003|NCT01829503|Primary|Proportion of Participants With Clinical Response (CR)|The number of participants (out of 39) who experienced Clinical Response as Complete Response, or, Complete Response + Complete Response with Incomplete Count Recovery (exact Clopper-Pearson confidence interval).|Up to 38 months|Evaluable participants with known Clinical Response (CR) (Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response), and participants who had Progressive Disease.|||Proportion of participants||90% Confidence Interval|Number
1348004|NCT01829503|Primary|Number of Participants by Best Clinical Response Experienced|The number of participants who experienced either a Complete Response, Complete Response with Incomplete Count Recovery, Partial Response, or Progressive Disease. Complete response: Less than 5% blasts in an aspirate sample of a patient who has an absolute neutrophil count of >1000µ/L and platelets >100,000µ/L; Complete response with incomplete count recovery: Complete response except for residual neutropenia (<1000µ/L) or thrombocytopenia (<100,000µ/L) Partial response: Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate; Progressive disease: Failure to achieve complete response or partial response|Up to 38 months|Evaluable participants with known Clinical Response.|||Participants|||Number
1348005|NCT01829477|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose value collected at week 24 or final visit relative to baseline.|Baseline and Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
1348006|NCT01829477|Secondary|Percentage of Participants With HbA1c <7 % at Week 24.||Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
1348008|NCT01829464|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose values collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1348011|NCT01829399|Secondary|Pain Score at Time of Tq Deflation|A visual analog pain score (VAS) from 0 to 10 was assessed at the time of Tq deflation. 0 indicating no pain, and 10 indicating the worst possible pain. All participants requested deflation prior to the maximum allowable 60 minutes, Subjects were instructed to request deflation at the same degree of discomfort for each visit. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.||||scores on a scale||95% Confidence Interval|Mean
1348012|NCT01829399|Primary|Time in Minutes That Tq Remained Inflated|15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.||||Minutes||95% Confidence Interval|Mean
1348013|NCT01829243|Secondary|MATRICS Consensus Cognitive Battery Composite Score|"(MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.~The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1348014|NCT01829243|Primary|Composite Brief Assessment of Cognition (BAC) Score|The composite BAC score is calculated by scoring each of the 6 individual tests (Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London), comparing each score to a healthy control sample to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1348015|NCT01829243|Primary|Changes in The Fatigue Severity Scale (FSS)|"The Fatigue Severity Scale (FSS) is composed of nine items with a seven-point response format. The minimum score = 9 and maximum score possible = 63. Higher scores = greater fatigue severity.~Sample questions include I am easily fatigued and Exercise brings on my fatigue. In the initial validation study, internal consistency for the Fatigue Severity Scale was high for specific illness groups (MS and lupus) and healthy controls. The scale clearly distinguished patients from controls and it was moderately correlated with a single-item visual analogue scale of fatigue intensity. In all patients, clinical improvement in fatigue was associated with reductions in scores on the Fatigue Severity Scale. The Fatigue Severity Scale is also a practical measure due to its brevity and ease of administration and scoring."|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.|||units on a scale||Full Range|Mean
1348016|NCT01829243|Primary|Visual Analogue Scale for Pain|Visual Analogue Scale for Pain operationally is a 100 mm line anchored by word descriptors at each end. The patient marks a point on the line that reflects their current pain state. The distance in mm from the left anchor point is the score. Higher scores indicate more pain.|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.|||mm||Full Range|Mean
1348017|NCT01829230|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.|Baseline and every 6 months up to 18 months|All subjects who have at least one data point.|||diopter (D)||Standard Deviation|Mean
1348018|NCT01829230|Primary|Axial Length of the Eye|Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.|Baseline and every 6 months post-baseline up to 18 months|All subjects who have at least one data point.|||millimeter (mm)||Standard Deviation|Mean
1348019|NCT01829191|Secondary|Axial Length|Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.|Baseline and every 6 months for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||millimeter (mm)||Standard Deviation|Mean
1348020|NCT01829191|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||diopter (D)||Standard Error|Mean
1348021|NCT01829165|Other Pre-specified|fMRI-assessed Resting Connectivity|From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits.|Up to 3 months.|||||||
1348022|NCT01829165|Other Pre-specified|Implicit Emotion Regulation|Implicit emotion regulation assessed through emotion conflict task performed during functional imaging. Performance based on reaction time and recruitment of emotion regulation regions during the task.|Up to 3 months|||||||
1348023|NCT01829165|Other Pre-specified|fMRI/TMS Assessed Neural Network Connectivity|From pre- to post-treatment, improvement will be based on enhanced functional connectivity.|Up to 3 months.|||||||
1348700|NCT01817491|Primary|Change in PAQ (Physical Activity Questionnaire)|PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.|baseline, 4 weeks|Children|||units on a scale||Standard Deviation|Mean
1348024|NCT01829165|Primary|Clinician Administered HAM-D|The Hamilton Depression Rating Scale (HAM-D) is a 24-item clinician-administered assessment utilized as a way of determining a patient's level of depression before, during, and after treatment. It takes approximately 15-20 minutes to complete the interview and score the results. Subscale scores are 0-2 (10 questions), 0-3 (2 questions), and 0-4 (12 questions). Subscales are totaled for an overall score (range 0 -76). For the overall score and all subscales, lower scores correspond to fewer symptoms, and higher scores correspond more symptoms.|Baseline; Day 10; Day 20|Randomized and treated|||units on a scale||Standard Deviation|Mean
1348025|NCT01829113|Secondary|Number of Patients With a Treatment-Related Adverse Event as a Measure of Safety.|A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.|Weekly during each 21 days cycle and for 30 days after last dose for up to 29 Months|Randomized patients who received at least one dose of study treatment.|||Participants|||Count of Participants
1348026|NCT01829113|Secondary|Median Overall Survival|Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive.|Every 6 weeks for up to 41 months|All patients who were randomized.|||Months||95% Confidence Interval|Median
1348027|NCT01829113|Secondary|Number of OGX-427 Versus Placebo Participants With an Objective Response|Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in baseline of 30% or more of the diameter(s) of all target lesions.|Every 6 weeks for up to 24 months|All patients who were randomized.|||Participants|||Count of Participants
1348028|NCT01829113|Primary|Median Progression-Free Survival|Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.|Every 6 weeks for up to 24 months|All patients who were randomized|||months||95% Confidence Interval|Median
1348029|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3)||24 hours (post dose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348030|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3)||5 hours (post dose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348031|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3)||1 hour 30 minutes (post dose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348032|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3)||25 minutes (post dose) Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348033|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3)||0 hour (predose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348034|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)||24 hours (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348035|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)||5 hours (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348036|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)||1 hour 30 minutes (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348037|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)||25 minutes (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
1348038|NCT01829048|Primary|Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2)||0 hour (predose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1348039|NCT01829048|Primary|Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3)|12-lead ECG (triplicate)was performed on Day 0 and 12-lead ECG (singlet) was performed at other time points as specified in timeframe. ECG criteria of potential clinical concern were 1), PR interval: >=300 msec; >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval: >=500 msec, QTcF interval: absolute value >=450 - <480 msec (borderline), >=480 msec (prolonged); absolute change 30 - <60 (borderline), >=60 msec (prolonged).|Screening up to Day 18|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1348701|NCT01817491|Primary|Change in Circumference||baseline, 4 weeks|Children and parents|||cm||Standard Deviation|Mean
1348702|NCT01817491|Primary|Change in Weight||baseline, 4 weeks|Children and parents|||kg||Standard Deviation|Mean
1348040|NCT01829048|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)|12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other time points as specified in timeframe. ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline was greater than (>) 200 msec; or increase >=50% when baseline was less than or equal to (<=) 200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), corrected QT interval (QTc interval): >=500 msec, QTc interval using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged); absolute change 30 - <60 (borderline), >=60 msec (prolonged).|Day 0 (Baseline) up to Day 10|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348041|NCT01829048|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)|Vital signs included BP (supine and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic >=30 mm Hg change from baseline in same posture, systolic <90 mm Hg; diastolic >=20 mm Hg change from baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine/sitting): <40 or >120 bpm; Standing: <40 or >140 bpm.|Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348042|NCT01829048|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)|Vital signs included blood pressure (BP; supine and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic >=30 millimeters of mercury (mm Hg) change from baseline in same posture, systolic <90 mm Hg; diastolic >=20 mm Hg change from baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine/sitting): <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.|Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348043|NCT01829048|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
1348044|NCT01829048|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348045|NCT01829048|Primary|Number of Participants With TEAEs (Cohort 3)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to last subject visit that were absent before treatment or that worsened relative to pretreatment state.|The time receiving the first dose of PF-02545920/placebo through the last Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348046|NCT01829048|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to last subject visit that were absent before treatment or that worsened relative to pretreatment state.|The time receiving the first dose of PF-02545920 or placebo through the last Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348047|NCT01829048|Primary|Number of Participants With Abnormal Neurological Examination Findings (Cohort 3)|The neurological examination included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger-nose, heel-shin, Romberg, tandem walking, positional and gaze-evoked nystagmus.|Day 0 up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348048|NCT01829048|Primary|Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2)|The neurological examination included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger-nose, heel-shin, Romberg, tandem walking, positional and gaze-evoked nystagmus.|Day 0 up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348049|NCT01829048|Primary|Number of Participants With Changes Since Screening in Physical Examination (Cohort 3)|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems was performed at Screening. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards assessment of subject reported symptoms and performed at other time points than Screening.|Screening up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348050|NCT01829048|Primary|Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2)|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems was performed at Screening. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards assessment of subject reported symptoms and performed at other time points than Screening.|Screening up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348076|NCT01828476|Primary|Biochemical Response to ABT-263 and Abiraterone and to ABT-263 in Combination With Hydroxychloroquine and Abiraterone in Patients That Are Progressing on Abiraterone|"Characterize biochemical response to ABT-263 and Abiraterone and to ABT-263 in combination with hydroxychloroquine and Abiraterone by looking at PSA levels."|5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.|||Participants|||Count of Participants
1348051|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Event code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Event code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories were assessed."|Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
1348052|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohort 3) at Day 19|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Event code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Event code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories were assessed."|Day 19|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
1348053|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Event code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Event code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories were assessed."|Day 0 (Baseline)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348054|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Event code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Event code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories were assessed."|Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348055|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Event code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Event code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories were assessed."|Day 11|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
1348056|NCT01829048|Primary|Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)|"Data relevant to the assessment of suicidality was mapped to the Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), suicide attempt (Event code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Event code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Event code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories were assessed."|Day 0 (Baseline)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
1348077|NCT01828281|Other Pre-specified|Mean Hours of CPAP Usage Per Day|Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.|3 months||||hours||Standard Deviation|Mean
1348078|NCT01828281|Secondary|Mean Changes in Adiponectin Over 3 Months|Mean changes in Adiponectin from baseline to 3 months.|Baseline, 3 months||||ug/ml||Standard Deviation|Mean
1348079|NCT01828281|Primary|Mesenteric Fat Thickness||3 months||||cm||Standard Deviation|Mean
1348057|NCT01829048|Primary|Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18|ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extrapyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Additionally, 4 CGI-S items were assessed on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill): CGI-S parkinsonism; CGI-S dystonia; CGI-S dyskinesia; CGI-S akathisia.|Day 0 (Baseline) up to Day 18|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Units on a scale||Standard Deviation|Mean
1348058|NCT01829048|Primary|Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10|ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extrapyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item was scored on a 6-point scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Additionally, 4 Clinical Global Impression of Severity (CGI-S) items were assessed on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill): CGI-S parkinsonism; CGI-S dystonia; CGI-S dyskinesia; CGI-S akathisia.|Day 0 (Baseline) up to Day 10|Safety analysis set included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
1348059|NCT01828983|Primary|Spouse Self Report of Depression|Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms.|Baseline, 6 months|Participants with data at baseline and 6 months|||units on a scale||Standard Error|Mean
1348060|NCT01828983|Primary|Spouse Self Report of Anxiety|Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.|baseline, and 6 months|Participants who had data at baseline and 6 months|||units on a scale||Standard Error|Mean
1348061|NCT01828983|Primary|Spouse Self-report of Resilience|Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.|Baseline, 6 months|Participants who had data at baseline and 6 months|||units on a scale||Standard Error|Mean
1348062|NCT01828593|Other Pre-specified|Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities||Baseline and Week 24|Sub-study|||cells/mm3||Full Range|Mean
1348063|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)|4th Baseline CD4+ Quartile (greater than 893)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
1348064|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)|3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
1348065|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630|2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
1348066|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)|Lowest baseline CD4+ quartile (less than or equal to 418)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
1348067|NCT01828593|Primary|Frequency of Daily Unformed Bowel Movements|Change in number of abnormal or unformed stools by week 4|Baseline and 4 weeks||||abnormal or unformed stools||Standard Deviation|Mean
1348068|NCT01828515|Primary|Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19|The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. A higher score reflects better performance.|Baseline and Day 19|All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.|||T-score||Standard Deviation|Mean
1348069|NCT01828476|Secondary|Overall Survival||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
1348070|NCT01828476|Secondary|Biomarkers of Autophagy Modulation by EM; and LC3, and/or p62 by Immunoblotting in PBMC and Tumor Tissue When Available||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
1348071|NCT01828476|Secondary|Bcl-2 Family Protein Expression (Bcl-2, Bcl-XL, MCL-1) in Paraffin Blocks When Available by Immunohistochemistry||5 years|Study was terminated warly and insufficient data was collected to assess this outcome measure.||||||
1348072|NCT01828476|Secondary|Circulating Tumor Cells Pre-enrollment and During Therapy||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
1348073|NCT01828476|Secondary|Measurable Tumor Response in Patients With Measurable Disease||5 years|Study was terminated early and insufficent data was collected to assess this outcome measure.||||||
1348074|NCT01828476|Secondary|Progression Free Survival||5 years|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1348075|NCT01828476|Secondary|Time to PSA Progression||5 years|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1348080|NCT01828216|Secondary|Difference in Healthcare Costs Between Ambulatory and Hospital Approach||within 24 months||||Hong Kong Dollars||Standard Deviation|Mean
1348703|NCT01817491|Primary|Change in Blood Pressure (BP)||baseline, 4 weeks|Children and parents|||mm Hg||Standard Deviation|Mean
1348081|NCT01828216|Primary|Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0–9 range is considered to be normal while a number in the 10–24 range indicates that expert medical advice should be sought.|Baseline and 3 months|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.|||units on a scale||Standard Deviation|Mean
1348082|NCT01828164|Secondary|Discomfort|Average measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the amount of pain on a 10 point scale. On the 10 point scale, 1 represents the least amount of pain and 10 represents the most amount of pain.|24 weeks or until the extraction space was closed (whichever came first)|Subjects who completed the study with device usage compliance of 67% or higher.|||units on a scale||Standard Deviation|Mean
1348083|NCT01828164|Secondary|Rate of Root Resorption|The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.|24 weeks or until the extraction space was closed (whichever came first)|Subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated. Only subjects with CBCT images were used.|||mm/week||Standard Deviation|Mean
1348084|NCT01828164|Primary|Rate of Tooth Movement|The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.|24 weeks or until the extraction space was closed (whichever came first)|As per approved protocol, only subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated.|||mm/week||Standard Deviation|Mean
1348085|NCT01828112|Secondary|Duration of Intracranial Response (DOIR)|DOIR is defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2019-10-31|10/2019||||
1348086|NCT01828112|Secondary|Intracranial Disease Control Rate (IDCR)|IDCR is defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2019-10-31|10/2019||||
1348087|NCT01828112|Secondary|Overall Intracranial Response Rate (OIRR)|OIRR is defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1* as assessed by BIRC neuroradiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2019-10-31|10/2019||||
1348088|NCT01828112|Secondary|Time to Definitive Deterioration||from the date of randomization to the date of event for disease related symptoms||2019-10-31|10/2019||||
1348089|NCT01828112|Secondary|Patient Reported Outcomes (PRO)||Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2019-10-31|10/2019||||
1348090|NCT01828112|Secondary|Time to Response (TTR)|TTR is defined as the time from date of randomization to date of first documented response (CR or PR)|Month 18||2019-10-31|10/2019||||
1348091|NCT01828112|Secondary|Disease Control Rate (DCR)|DCR is defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD)|Month 18||2019-10-31|10/2019||||
1348092|NCT01828112|Secondary|Duration of Response (DOR)|DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to underlying cancer|Month 18||2019-10-31|10/2019||||
1348093|NCT01828112|Secondary|Overall Response Rate (ORR)|ORR is defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR)|Month 18||2019-10-31|10/2019||||
1348094|NCT01828112|Secondary|Overall Survival (OS)|OS is defined as time from date of randomization to date of death due to any cause.|Month 18||2019-10-31|10/2019||||
1348095|NCT01828112|Primary|Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)|PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.|’from the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.|||Percentage of participants||95% Confidence Interval|Median
1348096|NCT01828099|Secondary|Patient Reported Outcomes|The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms.|Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks.||2018-06-30|06/2018||||
1348097|NCT01828099|Secondary|Time to Response (TTR)|TTR defined as the time from date of randomization to date of first documented response (CR or PR)|From randomization until death (up to approximately 34 months)||2018-06-30|06/2018||||
1348098|NCT01828099|Secondary|Disease Control Rate (DCR)|DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)|From randomization until death (up to approximately 34 months)||2018-06-30|06/2018||||
1348099|NCT01828099|Secondary|Duration of Response (DOR)|DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause|From randomization until death (up to approximately 34 months)||2018-06-30|06/2018||||
1348100|NCT01828099|Secondary|Overall Response Rate (ORR)|ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Review Committee (BIRC) and by investigator assessment per RECIST 1.1|From randomization until death (up to approximately 34 months)||2018-06-30|06/2018||||
1348101|NCT01828099|Secondary|Overall Survival (OS)|OS defined as time from date of randomization to date of death due to any cause|From randomization until death (up to approximately 34 months)||2018-06-30|06/2018||||
1348102|NCT01828099|Primary|Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)|PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause|from the date of randomization to the date of first radiologically documented disease progression or death due to any cause (assessed every 6 weeks up to approximately 34 months)|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.|||months||95% Confidence Interval|Median
1348103|NCT01827839|Secondary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Starting after 30 days post last vaccination until study end (i.e. Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
1348104|NCT01827839|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Starting after 30 days post last vaccination until study end (i.e. Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
1348105|NCT01827839|Secondary|Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value|The cut-off value was 97 mIU/mL.|At Month 0 and at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
1348106|NCT01827839|Secondary|Anti-gE Antibody Concentrations|Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.|At Month 0 and at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1348107|NCT01827839|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
1348108|NCT01827839|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Participants|||Count of Participants
1348109|NCT01827839|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Participants|||Count of Participants
1348110|NCT01827839|Primary|Number of Days With Solicited General Symptoms|The number of days with general symptoms during the solicited post-vaccination period.|Within 7 days (Day 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
1348111|NCT01827839|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Day 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with the symptoms sheet filled in.|||Participants|||Count of Participants
1348112|NCT01827839|Primary|Number of Days With Solicited Local Symptoms|The number of days with any local symptoms during the solicited post-vaccination period.|Within 7 days (Day 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
1348113|NCT01827839|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Day 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with the symptoms sheet filled in.|||Participants|||Count of Participants
1350458|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.|||IU||Full Range|Median
1348114|NCT01827839|Primary|Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA|"Vaccine response was defined as:~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE [4x97 milli-international units per milliliter (mIU/mL)]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
1348115|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline - Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a Scale||Standard Deviation|Mean
1348116|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a Scale||Standard Deviation|Mean
1348117|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Grams||Standard Deviation|Mean
1348118|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Grams||Standard Deviation|Mean
1348119|NCT01827670|Secondary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject’s response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a Scale||Standard Deviation|Mean
1348120|NCT01827670|Primary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject’s response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a scale||Standard Deviation|Mean
1348121|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1348233|NCT01826370|Primary|Frequency of Adverse Events and Serious Adverse Events|Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.|Week 24|Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.|||percentage of participants|||Number
1348122|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1348123|NCT01827592|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).~For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1348124|NCT01827592|Secondary|Total Patient Assessment of Constipation – Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.~PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.~Total PAC-QOL score was averaged from the individual item score."|At 12 weeks|The ITT analysis set consisted of all randomized (as planned) patients.|||Percentage of patients|||Number
1348125|NCT01827592|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .~For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on BSFS||95% Confidence Interval|Least Squares Mean
1348126|NCT01827592|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||SBM per week||95% Confidence Interval|Least Squares Mean
1348127|NCT01827592|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation (‘complete’).|Within the first 24 hours of treatment initiation|The ITT analysis set consisted of all randomized (as planned) patients was used for assessment.|||Percentage of patients|||Number
1348128|NCT01827592|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|Intention-to-treat (ITT) analysis set consisted of all randomized (as planned) patients.|||Percentage of patients|||Number
1348129|NCT01827475|Secondary|Need for Rescue Pain Relief|The need for additional analgesics|1 hour||||participants|||Number
1348130|NCT01827475|Primary|Pain Severity|Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)|1 hour||||mm||95% Confidence Interval|Mean
1348131|NCT01827462|Other Pre-specified|Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 28-32 for Responses to the Vaccine Antigens||Day 0-Day28|||||||
1348132|NCT01827462|Other Pre-specified|Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 5-7 for T Cells and Antibody-secreting Cells (ASCs)||Day 0 to 7|||||||
1348133|NCT01827462|Secondary|Number of Participants With Related Adverse Events|Related adverse events were recorded annually during this 10 year longitudinal study.|Day 0 to Day 28 following each annual vaccination while on study||||Participants|||Count of Participants
1348134|NCT01827462|Primary|Number of Participants Who Received the Influenza Vaccine||Day 0 annually while on study||||Participants|||Count of Participants
1348135|NCT01827371|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with IMVAMUNE was determined by the investigator and defined as Related, meaning a reasonable possibility that the study product caused the adverse event. Reasonable possibility was defined as there being evidence to suggest a causal relationship between the study product and the adverse event."|Day 1 after the first vaccination through 180 days after the 2nd vaccination.|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.|||participants|||Number
1348136|NCT01827371|Secondary|Geometric Mean Peak ELISA Titer After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of antibody titers by ELISA. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through 31 after the 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.|||titers||95% Confidence Interval|Geometric Mean
1348137|NCT01827371|Primary|Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration|Participants maintained a memory aid to record daily the occurrence of local injection site reactions for 15 days after vaccination based on their interference with daily activities (pain and itchiness at injection site, underarm pain and swelling) or based on a quantitative measurement of the reaction (redness, swelling). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions were present but did not interfere with daily activities. For the quantitative scale, severe reactions greater than 30 millimeters (mm), moderate reactions were 15-30mm, and mild reactions were 1-15mm. Participants are counted by the maximum severity on any of the 15 days, and for this outcome measure, only those reporting moderate or severe events are counted. Formal comparisons by Fisher's Exact test were conducted for Arm D (Stratis, Day 1,29) compared to A|15 days after each vaccination|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.|||percentage of participants|||Number
1348138|NCT01827371|Primary|Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through Day 31 after 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.|||titers||95% Confidence Interval|Geometric Mean
1348139|NCT01827358|Secondary|Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.|Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the according to protocol day 8 (ATP-8) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ATP-8 cohort includes all ATP infants who had a set of NUP cultures collected on Day 8 (± 2).|||Participants|||Count of Participants
1348140|NCT01827358|Secondary|Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).|Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the modified intent to treat (mITT-8) cohort. The time periods in the table correspond to the study days having collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The mITT cohort includes all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture. The mITT-8 cohort includes all mITT infants who either had a complete set of NUP cultures collected on day 8 or else had discontinuation of NUP cultures prior to Day 8 due to a clinical SA infection.|||Participants|||Count of Participants
1348141|NCT01827358|Secondary|Relative Risk of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group|The association between mupirocin treatment and severe (stage II-III) NEC on or before Day 85 was to be assessed via Cox Proportional Hazards Model.|Day 1 through 85|There were no events of necrotizing enterocolitis during the study, analysis could not be performed.||||||
1348142|NCT01827358|Secondary|Median Time to Occurrence of Non-S. Aureus (SA) Clinical Infection in the Treatment Compared to Control Group|Median time to occurrence of non-SA clinical infection in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.|Day 1 through 85|Clinical infection besides SA infection on or prior to Day 85 was not observed frequently enough to allow estimation of the median time to infection using non-parametric methods.||||||
1348159|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|4 weeks||||units on a scale||Full Range|Mean
1348160|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|2 weeks||||units on a scale||Full Range|Mean
1348143|NCT01827358|Secondary|Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.|Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the ATP cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 22|The ATP cohort includes all infants that have met all requirements of the mITT cohort, with the further requirements that infants in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.|||Participants|||Count of Participants
1348144|NCT01827358|Secondary|Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.|Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the intent to treat (ITT) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 22|The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.|||Participants|||Count of Participants
1348145|NCT01827358|Secondary|Median Time to Occurrence of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group.|Median time to occurrence of severe (stage II-III) NEC in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.|Day 1 through 85|There were no events of necrotizing enterocolitis during the study, analysis could not be performed.||||||
1348146|NCT01827358|Secondary|Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.|Relative risk of occurrence of non-SA clinical infection in the treatment compared to control groups using the according to protocol (ATP) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ATP cohort includes all infants with a site-specific pre-randomization NUP culture that is positive for SA by direct culture, those in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.|||Participants|||Count of Participants
1348147|NCT01827358|Secondary|Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort|Relative risk of occurrence of non-SA clinical infection in the treatment compared to the control group using the intent to treat (ITT) cohort for analysis. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.|||Participants|||Count of Participants
1348148|NCT01827358|Primary|Persistent Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures on Days 8 and 22.|Participants were admitted into the study based on being colonized with SA. Participants who were decolonized both on day 8 and day 22, as determined by NUP cultures were considered to have persistent decolonization. Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. NUP swabs were collected on day 8 and on day 22 and cultured by direct plating. If the cultures were negative for SA at both day 8 and day 22 the participant was considered to have persistent decolonization. Colonization with SA was a prerequisite for enrollment, because of this there was no baseline measure.|Day 8 and Day 22|The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who had either had complete sets of NUP cultures collected on day 8 and day 22 or else had discontinued NUP cultures prior to day 22 due to a clinical SA infection.|||Participants|||Count of Participants
1348298|NCT01824446|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents*hr/ml||Standard Deviation|Mean
1348149|NCT01827358|Primary|Primary Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures Obtained on Day 8.|Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. On day 8, participants were swabbed in each of three areas: nasal, umbilical, and perianal. These swabs were cultured by direct plating. If SA did not grow on any of these cultures the infant was considered to be decolonized. If SA grew on any one of these cultures the infant was considered to be colonized with SA.|Day 8|The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who either had a complete set of NUP cultures collected on Day 8 or else had discontinued NUP cultures prior to day 8 due to a clinical SA infection.|||Participants|||Count of Participants
1348150|NCT01827358|Primary|Number of Participants With Serious Adverse Events (SAEs) During Days 1-7|Participants were evaluated for Serious Adverse Events (SAEs) while in the NICU/ICU on days 1-7. Although participants received only 5 days of mupirocin, SAEs were collected through day 7. An adverse event or suspected adverse reaction was considered serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death; a life-threatening adverse event (an event that places the participant at immediate risk of death; it doesn't include an adverse event, had it occurred in a more severe form, might have caused death); inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or any other event that when based upon appropriate medical judgement may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.|||Participants|||Count of Participants
1348151|NCT01827358|Primary|Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7|Participants were evaluated for moderate and severe unsolicited adverse events (that were not otherwise considered pre-defined trial endpoints) while in the NICU/ICU on days 1-7. Although participants received 5 days of mupirocin, unsolicited events were collected until day 7. Moderate events were defined as those that may cause some interference with functioning and daily activities. Severe events were defined as those that interrupt the participant's usual daily activities and may require systemic drug therapy or other treatment. Severe events were usually incapacitating.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.|||participants||95% Confidence Interval|Number
1348152|NCT01827358|Primary|Number of Participants With Solicited Adverse Events (AEs) During Days 1-7|Participants were evaluated for solicited adverse events while in the NICU/ICU on days 1-7. Participants were counted if they experienced the symptom at any severity during the reporting period. Although participants received only 5 days of mupirocin, solicited events were collected through day 7.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.|||participants|||Number
1348153|NCT01827332|Secondary|Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )|Subjects' marijuana use was measured via self-report of number of smoking sessions per day (Time Line Followback). The average number of daily sessions were calculated per group, with data presented below representing the change in amount of daily smoking sessions per group from first MET session to last MET session.|Self-report of average daily smoking sessions at MET Session 1 and last MET session 3||||daily smoking sessions||Standard Error|Mean
1348154|NCT01827332|Primary|Therapy Session Satisfaction (as Measured by Subjective Report)|After MET sessions, subjects completed the Session Rating Scale (SRS, Miller et al). This visual analog scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall, with minimum score 0 representing most dissatisfied and maximum score 10 representing most satisfied. Outcome measure reported below represents SRS score at last MET session.|Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit||||units on a scale||Standard Error|Mean
1348155|NCT01827319|Secondary|2 CCS Angina Class Reduction|Canadian Cardiovascular Society (CCS) Angina Class-Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.|30 days||||participants|||Number
1348156|NCT01827319|Secondary|Major Adverse Cardiovascular Events (MACE) Rate, Defined as the Incidence of Cardiac-related Death, Myocardial Infarction (Q-wave and Non Q-wave), Congestive Heart Failure, Cerebrovascular Accident, and Serious Arrhythmia||30 days||||participants|||Number
1348157|NCT01827319|Primary|All Cause Mortality|Number of Participant Deaths|30 days||||participants|||Number
1348158|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|4 weeks||||units on a scale, from 0 to 10||Full Range|Mean
1348299|NCT01824446|Primary|Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||Liters||Standard Deviation|Mean
1348300|NCT01824446|Primary|CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS|||L/hr||Standard Deviation|Mean
1348161|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|2 weeks||||units on a scale||Full Range|Mean
1348162|NCT01827267|Secondary|Overall Survival (OS)|Defined as the time (month) from randomization to death due to any cause; censored at the date last known alive.|From randomization to death or end of long term follow-up, assessed up to 31.8 months.|All subjects who received at least 1 dose of drug|||months||95% Confidence Interval|Median
1348163|NCT01827267|Secondary|Progression Free Survival (PFS)|Defined as time from date of randomization until the first disease recurrence or progression per RECIST V1.1 or death due to any cause; censored at the last assessable evaluation or at the initiation of new anti-cancer therapy. Disease assessment is based on investigator tumor assessments. If no post-baseline tumor assessment then censored at enrollment date.|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least 1 dose of drug|||months||95% Confidence Interval|Median
1348164|NCT01827267|Secondary|Duration of Response (DOR)|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, progressive disease (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST (v1.1) criteria.|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least 1 dose of drug and had either complete or partial response.|||Participants|||Count of Participants
1348165|NCT01827267|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the proportion of patients who achieved objective response (CR or PR) or stable disease (SD) for at least 12 weeks.|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least one dose.|||Participants|||Count of Participants
1348166|NCT01827267|Primary|Objective Response Rate (ORR)|"ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met."|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least 1 dose of drug|||Participants|||Count of Participants
1348167|NCT01827254|Primary|Progression Free Survival: Third Line Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 23.7 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."|||months||95% Confidence Interval|Median
1348168|NCT01827254|Primary|Progression Free Survival: Second Line of Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 22.9 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."|||months||95% Confidence Interval|Median
1348169|NCT01827254|Primary|Progression Free Survival for Re-challenge With Sunitinib|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 52.2 months|Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure.|||months||95% Confidence Interval|Median
1348170|NCT01827254|Other Pre-specified|Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 24 months|Evaluable population: All participants included in the analysis.|||participants|||Number
1348191|NCT01826851|Primary|Median Cumulative Morphine Equivalent|The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.|Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.||||Morphine Equivalents||Inter-Quartile Range|Median
1348301|NCT01824446|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Standard Deviation|Mean
1348171|NCT01827254|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.|Baseline up to 98.0 months|Evaluable population: All participants included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1348172|NCT01827254|Secondary|Overall Survival|Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death – Start date of treatment) + 1)/365.25 x 12.|Baseline up to death or end of study (up to 98.0 months)|Evaluable population: All participants included in the analysis.|||months||95% Confidence Interval|Median
1348173|NCT01827254|Primary|Progression Free Survival With Sunitinib as First Line of Therapy|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression – Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 66.6 months|Evaluable population: All participants included in the analysis.|||months||95% Confidence Interval|Median
1348174|NCT01826981|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1348175|NCT01826981|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1348176|NCT01826981|Secondary|For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)||Posttreatment Weeks 16 and 20|Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.|||percentage of participants|||Number
1348177|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)||Posttreatment Weeks 2, 4, 8, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1348178|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 16, 20, and 24|Full Analysis Set|||percentage of participants|||Number
1348179|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1348180|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 10|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1348181|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1348182|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 1 and 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1348183|NCT01826981|Primary|Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)||Up to 24 weeks plus 30 days|Safety Analysis Set|||Percentage of participants|||Number
1348184|NCT01826981|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full analysis set: Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1348185|NCT01826851|Secondary|Time to Return to Work or Daily Activities|Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.|36 days|Data was not collected on 15 participants in the Exparel arm and 17 participant in the Placebo arm.|||Days||Standard Deviation|Mean
1348186|NCT01826851|Secondary|Hospital Length of Stay (Days)|Duration of time spent in the hospital following surgery.|25 days||||Days||Inter-Quartile Range|Median
1348187|NCT01826851|Secondary|Time to First Bowel Movement (Days)|Time to first bowel movement following surgery.|35 days|Data was not collected on 3 participants in the Exparel arm and 1 participant in the Placebo arm.|||Days||Inter-Quartile Range|Median
1348188|NCT01826851|Secondary|ICU Length of Stay (Hours)|Duration of time spent in the intensive care unit postoperatively.|135 hours||||Hours||Inter-Quartile Range|Median
1348189|NCT01826851|Secondary|Time to Extubation (Hours)|Time to remove endotracheal tube following surgery.|77 hours||||Hours||Inter-Quartile Range|Median
1348190|NCT01826851|Primary|Median Pain Levels|The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.|Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.||||units on a scale||Inter-Quartile Range|Median
1348302|NCT01824446|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Full Range|Median
1348192|NCT01826812|Secondary|Cytokines|Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.|Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.|The cytokine analysis was performed in the samples of selected participants based on their clinical signs and characteristics. The sample size of the groups was justified using the power analysis.|||pg/mL||Standard Error|Mean
1348193|NCT01826812|Secondary|Change in Visual Acuity||30 minutes||||logMAR||Standard Deviation|Mean
1348194|NCT01826812|Secondary|Change in Tear Osmolarity||Before and after 30 minutes reading||||mOsm/L||Standard Deviation|Mean
1348195|NCT01826812|Secondary|Change in Total Ocular Staining Score (OSS)|Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.|Before and after 30 minutes reading||||units on a scale||Standard Deviation|Mean
1348196|NCT01826812|Primary|Sustained Silent Reading Speed||30 minutes||||words/minute||Standard Deviation|Mean
1348197|NCT01826604|Secondary|Secondary Outcomes Will Include the Differences Between the Two Groups.|Secondary outcomes will include the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rates between the two groups.|From the time of surgery to 30 days post-op.|infection during 30 day postoperative period|||participants|||Number
1348198|NCT01826604|Primary|Wound Infection or Disruption|We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.|Time of surgery to 30 days post op|Any SSI or wound disruption during 30 day postoperative period|||participants|||Number
1348199|NCT01826513|Secondary|Number of Respiratory Event Related Arousals|Total number of respiratory event related arousals over the entire sleep period|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Respiratory-Event Related Arousals||Standard Deviation|Mean
1348200|NCT01826513|Secondary|Percentage of Total Sleep Time Spent in Each Sleep Stage|Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||percentage of total sleep time||Standard Deviation|Mean
1348201|NCT01826513|Secondary|Oxygen Saturation|Oxygen saturation recorded in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||percentage SpO2||Standard Deviation|Mean
1348202|NCT01826513|Secondary|Number of Central Apnoeas|Total number of central apnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Central Apnoeas||Standard Deviation|Mean
1348203|NCT01826513|Secondary|Number of Obstructive Apnoeas|Total number of obstructive apnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Obstructive Apnoeas||Standard Deviation|Mean
1348204|NCT01826513|Secondary|Number of Hypopnoeas|Total number of hypopnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Hypopneas||Standard Deviation|Mean
1348205|NCT01826513|Secondary|Number of Spontaneous Arousals|Number of spontaneous arousals occurring over the entire total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Spontaneous Arousals||Standard Deviation|Mean
1348206|NCT01826513|Secondary|Time Taken to Fall Asleep|Time in minutes taken to fall alseep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||minutes||Standard Deviation|Mean
1348207|NCT01826513|Secondary|Wake After Sleep Onset Time|Time awake in minutes after initial sleep onset|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||minutes||Standard Deviation|Mean
1348208|NCT01826513|Secondary|Sleep Efficacy|Sleep time divided by total time available for sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||percentage of total recorded time||Standard Deviation|Mean
1348209|NCT01826513|Primary|Oxygen Desaturation Index (ODI)|Number of oxygen desaturations per hour of sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||events/hour||Standard Deviation|Mean
1348210|NCT01826513|Primary|Apnoea Hypopnoea Index (AHI)|Number of apnoeas and hypopnoeas per hour of sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||events/hour||Standard Deviation|Mean
1348211|NCT01826422|Secondary|Incorporation of EPA in the Erythrocytes|The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography.|Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6||||percentage of change respect at basal||Full Range|Median
1348212|NCT01826422|Secondary|Incorporation of DHA in the Erythrocytes|The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography.|Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
1348213|NCT01826422|Secondary|Markers of Muscle Regeneration (FGF)|Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
1348214|NCT01826422|Secondary|Markers of Muscle Regeneration (VEGF)|Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA).|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
1348215|NCT01826422|Secondary|Markers of Muscle Degeneration (Receptor of Fas)|The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
1348216|NCT01826422|Secondary|Markers of Muscle Degeneration (sFas)|The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
1348217|NCT01826422|Secondary|Markers of Muscle Degeneration (MMP9)|Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL.|Time Frame: At baseline and at months 1, 2, 3 of supplementation.||||percentage of change respect at basal||Full Range|Median
1348218|NCT01826422|Secondary|Markers of Muscle Degeneration (Creatinine Kinase)|The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348219|NCT01826422|Secondary|Inflammation Biomarker (IL-1 Expression)|The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR).|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348220|NCT01826422|Secondary|Inflammation Biomarker (TNF-A Expression)|The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR)|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348221|NCT01826422|Secondary|Inflammation Biomarker (IL-6 Expression)|The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR).|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348222|NCT01826422|Secondary|Inflammation Biomarkers (IL-10)|Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348223|NCT01826422|Secondary|Inflammation Biomarkers (IL-6)|Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348224|NCT01826422|Secondary|Inflammation Biomarkers (IL-1)|Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348225|NCT01826422|Secondary|Inflammation Biomarkers (TNF-A)|Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
1348226|NCT01826422|Primary|Insulin in Blood|A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||µU/mL||Full Range|Median
1348227|NCT01826422|Primary|Glucose in Serum|A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||mg/dL||Full Range|Median
1348228|NCT01826422|Primary|Anthropometric Measurement: Body Mass Index|We measured weight, height by anthropometric to calculate the body mass index (body mass index).|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||g/m^2||Full Range|Median
1348229|NCT01826422|Primary|Lean Mass|We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||g/kg of body weight||Full Range|Mean
1348230|NCT01826422|Primary|Body Composition (Body Fat)|We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).|At baseline and at months 3 and 6 of supplementation.||||g/Kg of body weight||Full Range|Median
1348234|NCT01826227|Primary|Sensitivity|of detection of lesions with PET probes compared to preoperative FDG18F-FDG PET and standard intraoperative examination. Sensitivity is defined as the percent of lesions that were found with malignant disease divided by the number of lesions with true presence of malignant disease based on the pathology report. A higher sensitivity will indicate a higher number of lesions found with the respective technique thus providing an initial estimate of the incremental benefit of the PET probe as opposed to the other techniques|2 years|Data not available because the PET probe failed.|||Participants|||Count of Participants
1348235|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-24h|AUC0-24 is the area under the concentration-time curve from time zero to 24 hours done only on 800 mg once a day schedule. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-24h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||ng*hr/mL||Standard Deviation|Mean
1348236|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-8h|AUC0-8h is the area under the concentration-time curve from time zero to 8 hours. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-8h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||ng*hr/mL||Standard Deviation|Mean
1348237|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Tmax|Tmax is the time to reach Cmax. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. Tmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||hr||Inter-Quartile Range|Median
1348238|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Cmax|Cmax is the maximum observed plasma concentration after drug administration.The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the pharmacokineticist. Cmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1, Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||ng/mL||Standard Deviation|Mean
1348239|NCT01826214|Secondary|Overall Response Rate (ORR)|ORR was the rate of complete remission (CR), complete remission with incomplete blood count recovery (CRi) or partial response (PR) according to IWG criteria. CR, CRi or PR will be assessed through bone marrow biopsy/aspirate and peripheral blood blasts counts.|Every 8 weeks for the first 6 months and every 12 weeks until 53 weeks after the last patient is enrolled or until relapse up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."|||Participants|||Number
1348240|NCT01826214|Primary|Complete Remission With Incomplete Blood Count Recovery (CRi)|The other primary efficacy endpoint was CRi based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CRi. A treatment cycle was defined as 4 weeks. No statistical analysis was planned for this primary outcome.|within 3 days after clearance of blasts from peripheral blood (PB), monthly thereafter until CR or reappearance of blasts in the PB, after CR every other month until discontination up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."|||Participants|||Number
1348241|NCT01826214|Primary|Rate of Complete Remission (CR)|Complete Response (CR) was based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CR. A treatment cycle was defined as 4 weeks. The outcome measure for the study is based on standardized response criteria as defined by the International Working Group (IWG) for AML. The IWG was established by a group of investigators interested in the design and conduct of clinical trials in acute myeloid leukemia (AML). The criteria established by this group (a set of recommendations for response assessment) are well established, endorsed by major institutions and Health Authorities, and are widely used in clinical trials. No statistical analysis was planned for this primary outcome.|at screening, every week up to Week 9, every 2 weeks thereafter until CR, every 4 weeks after CR up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized. No statistical analysis were reported in this study."|||Participants|||Number
1348303|NCT01824446|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents/ml||Standard Deviation|Mean
1348304|NCT01824446|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents*hr/g||Standard Deviation|Mean
1348242|NCT01826201|Secondary|Safety Assessment|Safety will be assessed based on reported adverse events, physical examination, vital signs, electrocardiograms, hematology, serum chemistry and urinalysis. Adverse events will be reported throughout the trial. Vital signs will be performed at screening, baseline, prior to the morning dose on Days 0, 1, 7, 14, 28, and at the follow up visit on Day 42. Physical examinations will be performed at Screening, baseline and Day 28. Hematology, serum chemistry and urinalysis will be performed at screening, baseline, Days 1, 7, 14, 28, and at the follow up visit on Day 42. ECGs will be performed at Screening, baseline and Day 28.|Baseline and Day 28|||||||
1348243|NCT01826201|Secondary|Change in EIS Area|Change in Erythema, Induration and Scale (EIS) area. Total score will be the EIS x Area, and will be calculated at baseline, Day 7, Day 14 and Day 28. The EIS will represent the sum of individual scores of Erythema, Induration and Scale using the same scale utilized in the PSS. The area of active erythema, induration and scale will be measured and the total scores will be calculated from the EIS scores multiplied by the area in cm2.|Baseline and Day 28|||||||
1348244|NCT01826201|Secondary|Treatment Success|Percent of patients achieving treatment success in the treatment group compared to the placebo group on day 28. Treatment success is defined as patient achieving a psoriasis severity score (PSS) of 3 or less, or an improvement of 5 points or more on the PSS.|Baseline and Day 28|||||||
1348245|NCT01826201|Secondary|Physician's Treatment Preference|The physician's treatment preference utilizing visual assessment and selection of the most improved plaque. The determination will be either 1)right lesion is preferred compared to left, 2)left lesion is preferred compared to right, 3) no difference between the right and left lesion.|Day 7, Day 14, Day 28|Per protocol|||participants|Participants||Number
1348246|NCT01826201|Secondary|Improvement in Lesion Appearance|Photography of the MOL4239 and placebo treated lesions will be performed at baseline, Day 7, Day 14 and Day 28 to assess for the improvement in lesion appearance after drug treatment. The assessment will be completed by a blinded panel of dermatologists experienced in the assessment of psoriasis.|Baseline and Day 28|||||||
1348247|NCT01826201|Primary|Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions|"he study drug application sites were scored for erythema, induration, and scale assessment using the PSS Scoring system. Psoriasis Severity Score (PSS) Erythema 0 - 4, 0 None, may have residual non-erythematous discoloration~1 Faint erythema 2 Moderate erythema/red color 3 Severe erythema/very red discoloration 4 Very severe erythema/extreme red coloration Induration 0 - 4 0 None~Trace or slight elevation of plaque above normal skin level~Moderate elevation with rounded or sloped edges to plaque~Marked elevation with hard, sharp edges to plaque~Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4~0 None~Fine scales~Coarse scales~Thick scales with a rough surface~Thick scales with a very rough surface~The scores were summed"|Baseline and Day 28||||PSS score|Participants|Standard Deviation|Mean
1348248|NCT01825941|Primary|Number of Participants With Sustained Headache Relief Assessed by Self-evaluation|"Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after discharge from emergency department"|up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department||||Participants|||Count of Participants
1348249|NCT01825837|Primary|Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)|The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change. The concept of improvement refers to the clinical distance between the individual’s current condition and that prior to the start of treatment. The scale for ‘severity of illness’ measures mania, depression and overall illness on a 7 point scale from 1 (‘normal, not ill’) to 7 (‘very severely ill’). The scale for ‘change from preceding phase’ and ‘change from worst phase’ measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 (‘not applicable’). If the patient, in ‘change from preceding phase’, at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.|6 months||||participants|||Number
1348250|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Insulin)||Baseline, 16 Weeks||||16-week change insulin fasting (µIU/mL)||95% Confidence Interval|Mean
1348251|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Glucose)||Baseline, 16 Weeks||||16-week change in gluclose (mg/dL)||95% Confidence Interval|Mean
1348252|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Triglycerides)||Baseline, 16 Weeks||||16-week change in triglycerides (mg/dL)||95% Confidence Interval|Mean
1348253|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (HDL)||Baseline, 16 Weeks||||16-week change in HDL (mg/dL)||95% Confidence Interval|Mean
1348254|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (LDL)||Baseline, 16 Weeks||||16-week change in LDL (mg/dL)||95% Confidence Interval|Mean
1348255|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Total Cholesterol)||Baseline, 16 Weeks||||16-week change total cholesterol (mg/dL)||95% Confidence Interval|Mean
1348256|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Hip Circumference)||Baseline, 16 Weeks||||centimetres||95% Confidence Interval|Mean
1348257|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Abdominal Circumference)||Baseline, 16 Weeks||||centimetres||95% Confidence Interval|Mean
1348258|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Absolute BMI)||Baseline, 16 Weeks||||16-wk change in BMI (kg/m2)||95% Confidence Interval|Mean
1348259|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Relative Change in Weight)||Baseline, 16 Weeks||||16-wk change in weight (z-score)||95% Confidence Interval|Mean
1348260|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Absolute Change in Weight)||Baseline, 16 Weeks||||16-wk change in weight (kg)||95% Confidence Interval|Mean
1348261|NCT01825798|Primary|Change in Body Mass Index Z-score||Baseline, 16 Weeks||||16-wk change in BMI z-score||95% Confidence Interval|Mean
1348262|NCT01825577|Secondary|POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.|Performance Oriented Mobility Assessment (POMA), used to measure subject's ability to maintain balance. The test takes 10-15 minutes and involves asking subject to stand from a sitting position, standing with eyes closed and sitting down. POMA total score has a range of 0-36 where higher scores represent better performance. POMA total score is an additive combination of the 12 point Gait sub-score and the 16 point balance sub-score. A cut-off score of <21 is generally considered a fall risk among elderly people.|4 weeks|Elderly patients living in community nursing homes identified as fall risk with a diagnosis of probable Alzheimer's Disease.|||Units on a scale||Standard Deviation|Mean
1348263|NCT01825577|Primary|Timed Get Up and Go Test - Measure of Mobility|Timed Get Up and Go Test (TUG), is used to evaluate the ability to walk by measuring the time it takes to rise from a chair, walk 10 feet, turn around, walk back to the chair, and sit down. The TUG test takes less than 5 minutes to complete. Scored as seconds required to complete the task.|Baseline and Post-test at 4 weeks|Elderly patients living in community nursing homes identified as fall risks with a diagnosis of probable Alzheimer's disease.|||seconds||Standard Deviation|Mean
1348264|NCT01825408|Primary|Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy|Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.|7-8 weeks after initiating antibiotics||||Participants|||Count of Participants
1348265|NCT01825408|Primary|Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy|Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.|4-5 weeks after starting antibiotics||||Participants|||Count of Participants
1348266|NCT01825200|Secondary|Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety|Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
1348267|NCT01825200|Secondary|Number of Participants With Local and Systemic Events Reported as a Measure of Safety|Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
1348268|NCT01825200|Secondary|Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration|Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
1348269|NCT01825200|Primary|Number of Participants With Common Hypersensitivity Reactions as Measure of Safety|Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
1348270|NCT01825122|Primary|Change From Baseline in the Average Number of Cigarettes Smoked Per Day||Baseline to end of treatment, up to 15 weeks|The analysis population reflects all patients who achieved maintenance dosing, including those who did not complete the study|||participants|||Number
1348271|NCT01824979|Secondary|Number of Mask Interventions During the Night|Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.|One night|While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.|||units on a scale||Full Range|Mean
1348272|NCT01824979|Primary|Technician Experience With Mask|Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.|One night|While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.|||Units on a Scale||Full Range|Mean
1348305|NCT01824446|Primary|Volume of Distribution (Vz/F) of Radiolabelled SSP-004184|The distribution of a medication between plasma and the rest of the body.|Up to 288 hours post-dose|PAS|||Liters||Standard Deviation|Mean
1348306|NCT01824446|Primary|Total Body Clearance (CL/F) of Radio-Labelled SSP-004184|The rate at which a drug is removed from the body.|Up to 288 hours post-dose|PAS|||L/hr||Standard Deviation|Mean
1348273|NCT01824901|Primary|Maximum Tolerated Dose (MTD) of FGFR Inhibitor AZD4547|A total of 3 dose levels of AZD4547 were planned: 40mg (level 1), 60mg (level 2), and 80mg (level 3) in combination with a standard dose of docetaxel (75mg/m^2). The starting dose level of AZD4547 was 40 mg. This portion of the study used a standard 3+3 design with patients enrolled in cohorts of 3. The plan was to recommend the maximum tolerated dose (MTD) as the dose level to be used in the phase II portion of the study. MTD is defined as the highest dose level at which less than or equal to 1 of 6 subjects experience dose limiting toxicity (DLT).|Assessed during cycle 1 (21 days)||||mg|||Number
1348274|NCT01824823|Primary|Disease-free Survival (DFS)|DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.|Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration|All randomized patients|||months||95% Confidence Interval|Median
1348275|NCT01824602|Primary|Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 – 60) based on the patient’s subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population of 37 patients consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).|||units on a scale||Standard Error|Mean
1348276|NCT01824589|Secondary|Arterial Blood Gases (PaCO2)|Arterial blood gases will be collected.|15 minutes after device activation||||mmHg|||Number
1348277|NCT01824589|Secondary|Lung Compliance|Change in lung compliance following each ITPR treatment compared to baseline.|baseline and immediately after device removal||||ml/cmH2O|||Number
1348278|NCT01824589|Secondary|Cerebral Perfusion Pressure (CPP)|Measurement of the difference between baseline CPP and CPP at 15 minutes|15 minutes after device activation||||mmHg|||Number
1348279|NCT01824589|Primary|Intracranial Pressure (ICP)|Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.|15 minutes after device is activated||||mmHg|||Number
1348280|NCT01824576|Secondary|Change From Baseline in Oxygen Saturation (SpO2)|Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR|basseline to 15 minutes following device use||||percentage of saturation||Standard Deviation|Mean
1348281|NCT01824576|Secondary|Change From Baseline in End-tidal Carbon Dioxide (EtCO2)|Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
1348282|NCT01824576|Secondary|Change From Baseline in Pulse Pressure (PP)|Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
1348283|NCT01824576|Secondary|Change From Baseline in Heart Rate (HR)|Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||beats/min||Standard Deviation|Mean
1348284|NCT01824576|Secondary|Change From Baseline in Mean Arterial Pressure (MAP)|Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
1348285|NCT01824576|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
1348286|NCT01824576|Secondary|Change From Baseline in PaCO2|PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.|baseline and 15 minutes after device activation|PaCO2 values for comparison were not available for two subjects|||mmHg||Standard Deviation|Mean
1348287|NCT01824576|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR|baseline to15 minutes following device use||||mmHg||Standard Deviation|Mean
1348288|NCT01824576|Primary|Change From Baseline in Cerebral Perfusion Pressure (CPP)|Change from average baseline CPP compared with the average CPP during use of the ITPR.|During 120 minutes of device use||||mmHg||Standard Deviation|Mean
1348289|NCT01824498|Primary|E2|Estradiol|8 weeks||||pmol/L||Standard Error|Least Squares Mean
1348290|NCT01824498|Primary|Plasma Sex Hormone Levels||8 weeks|||||||
1348291|NCT01824446|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||percentage of radioactivity||Standard Deviation|Mean
1348292|NCT01824446|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||percentage of radioactivity||Standard Deviation|Mean
1348293|NCT01824446|Primary|Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||Liters||Standard Deviation|Mean
1348294|NCT01824446|Primary|CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS|||L/hr||Standard Deviation|Mean
1348295|NCT01824446|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Standard Deviation|Mean
1348296|NCT01824446|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Full Range|Median
1348297|NCT01824446|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents/ml||Standard Deviation|Mean
1348310|NCT01824446|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 288 hours post-dose|The Pharmacokinetic Analysis Set (PAS) was defined as all subjects in the Safety Analysis Set (SAS) for whom the primary pharmacokinetic data are considered sufficient and interpretable. The SAS consisted of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*hr/ml||Standard Deviation|Mean
1348311|NCT01824355|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree.'|1 hour|Four subjects of those enrolled (113 subjects) had either missing or unevaluable questionnaire data.|||participants|||Number
1348312|NCT01824355|Secondary|Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff|Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|one hour|220 Blood Glucose results were analyzed. Study Staff provided 2 Blood Glucose Test Results from each subject who completed (110 subjects) the study.|||percentage of Blood Glucose Results|Participants||Number
1348313|NCT01824355|Secondary|Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method.|Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) and within +/- 15% (>=75mg/dL YSI capillary plasma).|1 hour|209 (220-11) Blood Glucose results were analyzed. 2 subjects had low blood sugar and per protocol their 4 AST BG results were not evaluable. 3 BG results were excluded as they were protocol deviations. One subject (2 BG results) did not complete testing within protocol timeframe and one subject (2 BG results) was unable to obtain AST blood.|||percentage of AST Blood Glucose Results|Participants||Number
1348314|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results <100mg/dL) and within +/- 12.5% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.|||percentage of Blood Glucose Results|Participants||Number
1348315|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <100mg/dL) and within +/- 15% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.|||percentage of Blood Glucose Results|Participants||Number
1348316|NCT01824355|Primary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method – YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.|||percentage of BG results|Participants||Number
1348317|NCT01824342|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); 2 = Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5 = Dead.|Baseline and Week 49|Safety analysis set with available data at both time points|||participants|||Number
1348318|NCT01824342|Primary|Number of Participants With Anti-denosumab Neutralizing Antibody Formation||3 years|Participants exposed to open-label denosumab with ≥ 1 antibody sample|||participants|||Number
1348319|NCT01824342|Primary|Percent Change From Baseline in Laboratory Values||Baseline and Week 49|Safety analysis set with available laboratory data at each time point.|||percent change||Standard Deviation|Mean
1348769|NCT01815918|Primary|Plasmin-alpha-2-antiplasmin Complex (PAP), a Marker of Fibrinolysis|Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP|Baseline and up to 4 hours following surgery||||ug/L||Standard Deviation|Mean
1348320|NCT01824342|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths|A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).|From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study.|Safety analysis set, which included participants who had properly documented informed consent for protocol 20080585 and received at least 1 dose of open-label denosumab.|||participants|||Number
1348321|NCT01824303|Secondary|Change From Baseline in Brief Pain Inventory (BPI)|The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
1348322|NCT01824303|Secondary|Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)|The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
1348323|NCT01824303|Secondary|Change From Baseline in O’Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score|The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
1348324|NCT01824303|Secondary|Change From Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
1348325|NCT01824303|Secondary|Change From Baseline in Post-Void Bladder Pain|Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||units on a scale||Standard Deviation|Mean
1348326|NCT01824303|Secondary|Change From Baseline in Average Void Volume Per Micturition|Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||mL||Standard Deviation|Mean
1348327|NCT01824303|Secondary|Change From Baseline in Night-Time Daily Voids|Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||voids||Standard Deviation|Mean
1348328|NCT01824303|Secondary|Change From Baseline in Total Daily Voids|Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||voids||Standard Deviation|Mean
1348329|NCT01824303|Primary|Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)|Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 12|Intent-to-treat (ITT) population included all randomized participants.|||unit on a scale||Standard Deviation|Mean
1350459|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.|||IU||Standard Deviation|Mean
1348330|NCT01824160|Primary|Successful Repair of Conduit Disruption|"Successfully cover a tear or disruption in a RV-PA conduit wall and prevent the development of rupture or bleeding into the mediastinum during additional enlargement of the conduit. Provide persistent conduit wall integrity.~A severity of illness scale categorizes the degree of clinical illness at baseline to be compared to the remaining level of illness after placement of the Covered CP Stent (CCPS). We assess the number of participants with minimal level of illness (level 0 to 1) after CCPS placement.~0 = No injury or conduit wall disruption~= Contained disruption~= Partially contained disruption~= Uncontained conduit disruption"|Implant of Covered Stent and 6 month follow up||||participants|||Number
1348331|NCT01823679|Secondary|Overall Survival (OS) at 2 Years|Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.|2 years||||percentage of participants|||Number
1348332|NCT01823679|Secondary|Overall Survival (OS) at 1 Year|Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.|1 year||||percentage of participants|||Number
1348333|NCT01823679|Secondary|Progression-free Survival (PFS) at 2 Years|Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.|2 years||||percentage of participants|||Number
1348334|NCT01823679|Secondary|Progression-free Survival (PFS) at 1 Year|Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.|1 year||||percentage of participants|||Number
1348335|NCT01823679|Primary|Objective Response Rate (ORR)|Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|9 weeks (3 cycles)||||percentage of participants|||Number
1348336|NCT01823653|Secondary|Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement|"Mean Investigator improvement at 12 weeks using the GAIS Scale.~*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol|||units on a scale||Standard Deviation|Mean
1348337|NCT01823653|Secondary|Subcutaneous Adipose Thickness|Ultrasound assisted measurement of adipose tissue thickness|12 weeks|||||||
1348338|NCT01823653|Secondary|Safety Assessment|Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.|1, 4, 8, 12 weeks|||||||
1348339|NCT01823653|Secondary|Patient Satisfaction Using 1-5 Likert Scale|Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below|12 weeks|Per protocol|||percentage of subjects satisfied|||Number
1348340|NCT01823653|Secondary|Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator|"Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment.~*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol|||Percentage of subjects improved|||Number
1348341|NCT01823653|Primary|Clinical Improvement in Thigh Circumference|Clinical improvement measured by change from baseline thigh circumference after treatment|12 weeks (minus baseline)|Per Protocol|||centimeter||Standard Error|Least Squares Mean
1348342|NCT01823614|Other Pre-specified|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients||24 weeks||||participants|||Number
1348343|NCT01823614|Secondary|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count||24 weeks||||participants|||Number
1348344|NCT01823614|Primary|Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia||24 weeks||||participants|||Number
1348345|NCT01823536|Secondary|Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal.|Day 1 to day 28|The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data.|||Number of subjects|||Number
1348346|NCT01823536|Secondary|Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|"The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,~Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine~Vaccine-naive subjects."|Day 1 to day 7 post-vaccination|The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data.|||Number of subjects|||Number
1348347|NCT01823536|Secondary|Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs.|Day 28 post-vaccination|The analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1348348|NCT01823536|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8.|Day 28 post-vaccination|The analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1348385|NCT01822821|Primary|Cumulative Opioid Consumption|Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.|End of surgery through 24 hours after surgery||||mg morphine equivalents||Inter-Quartile Range|Median
1348349|NCT01823536|Secondary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects|The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects.|5 years post-vaccination; baseline for naive|The analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1348350|NCT01823536|Secondary|Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.|The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.|5 years post-vaccination|The analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1348351|NCT01823536|Primary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine|"The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.~The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA)."|5 years post-vaccination|The analysis was done on per-protocol population i.e all subjects who provided immunogenicity data; had no major protocol deviations and who were not excluded due to other reasons defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1348352|NCT01823510|Secondary|Platelet Reactivity Index (PRI)|Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay.|up to 7 days||||percentage of baseline PRI||Standard Error|Mean
1348353|NCT01823510|Secondary|P2Y12 Reaction Unit (PRU)|Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow|up to 7 days||||percentage of baseline PRU||Standard Error|Mean
1348354|NCT01823510|Secondary|Platelet Reactivity|Platelet reactivity by Multiplate Analyzer|up to 7 days||||percentage of baseline Unit||Standard Error|Mean
1348355|NCT01823510|Primary|Thrombus Formation|Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).|up to 7 days||||percentage of baseline size||Standard Error|Mean
1348356|NCT01823341|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of mornings|Participants||Number
1348357|NCT01823341|Secondary|Morning Blood Ketones >=1.0 mmol/L|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of mornings|Participants||Number
1348358|NCT01823341|Secondary|Percentage of Mornings With Blood Glucose >250 mg/dL (>13.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of mornings|Participants||Number
1348359|NCT01823341|Secondary|Mean Morning Blood Glucose|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||mg/dL|Participants|Standard Deviation|Mean
1348360|NCT01823341|Secondary|Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of time|Participants|Inter-Quartile Range|Median
1348361|NCT01823341|Secondary|Percentage of Time Overnight Sensor Glucose Values 71 to 180 mg/dL (3.9 to 10.0 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of time|Participants|Standard Deviation|Mean
1348362|NCT01823341|Secondary|Mean Sensor Glucose Overnight|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||mg/dL|Participants|Standard Deviation|Mean
1348363|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of nights|Participants||Number
1348364|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of nights|Participants||Number
1348365|NCT01823341|Primary|Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.|"Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL (3.9 mmol/L). The time period for outcome assessment each night will be from the time the system is activated in the evening until the time it is deactivated in the morning. The percentage of hypoglycemic nights (CGM glucose value ≤70 mg/dL (3.9 mmol/L)) will be tabulated separately with versus without the closed-loop control system in use. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|||percentage of time|Participants|Inter-Quartile Range|Median
1348366|NCT01823289|Primary|Number of Participants With Comprehensive Efficacy|Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.|||participants|||Number
1348367|NCT01823289|Primary|Number of Participants With Mycological Efficacy|Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit. Here 'N' signifies those participants who were evaluable for this measure.|||participants|||Number
1348368|NCT01823289|Primary|Number of Participants With Clinical Efficacy|Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.|||participants|||Number
1348369|NCT01823224|Secondary|Total Opioid Consumption From Time of First Waking to T24|"Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:~Opioid consumption from first waking to T4~Total opioid consumption from T0 to T4~Total opioid consumption from time of first waking to T24"|every 6 hours for 24 hours||||milligrams||Standard Deviation|Mean
1348370|NCT01823224|Primary|Pain|Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.|24 hours after discharge||||NRS scale||Standard Deviation|Mean
1348386|NCT01822756|Secondary|Duration of Response|Duration of response was the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response. Confidence intervals for median duration of response were calculated using the method of Brookmeyer and Crowley (1982).|Randomization to clinical cutoff 22Sept2015 (approx 244 days)|Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX|||days||Full Range|Median
1352704|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1348371|NCT01823146|Secondary|Functional Connectivity (Resting fMRI)|The functional connectivity (strength measure in units on a scale) between amygdala and medial prefrontal cortex was measured via a resting functional magnetic resonance imaging scan (participants looked at a fixation cross while images of their brain at rest were taken). Functional connectivity is the connectivity between brain regions (i.e., amygdala and medial prefrontal cortex) that share functional properties. It is defined as the temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. A mean of this correlation (connectivity strength) was computed and transformed into z-scores (r to z transformation). The z-scores ranged from -2 to +2 with higher scores representing a greater resting-state functional connectivity.|1.5 hours after oxytocin/placebo administration|All study participants who had undergone the screening as well as the full visit and had reliable resting fMRI scan data (e.g., low extent of head motion) (n = 79).|||z-scores||95% Confidence Interval|Least Squares Mean
1348372|NCT01823146|Secondary|Meta-Mood|Mean self-reported level of meta-mood for the two subscales attention to feelings and clarity of feelings. Response scale ranged from 1 to 5, with higher scores indicating more attention to feelings and greater clarity of feelings, respectively. The mean score for the subscales were calculated.|2.5 hours after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).|||units on a scale||Standard Error|Mean
1348373|NCT01823146|Primary|Extent of Trust Behavior|"Average amount of monetary units invested in the context of the Trust/Lottery Game.~The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately."|45 minutes after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).|||monetary units||Standard Error|Mean
1348374|NCT01822899|Secondary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. BL is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on Treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1values obtained 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84). Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, and day by BL and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1348375|NCT01822899|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Par. analyzed were those with data available at the presented time point but all par. without missing covariate information and with >= post BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1348376|NCT01822821|Secondary|Total Bilirubin (mg/dL)||Measured at 1 day and 2 days after surgery||||mg/dL||Inter-Quartile Range|Median
1348377|NCT01822821|Secondary|Aspartate Aminotransferase (AST); U/L||Two days after surgery or date of death from any cause, whichever came first||||U/L||Inter-Quartile Range|Median
1348378|NCT01822821|Secondary|Alanine Aminotransferase (ALT); U/L||Two days after surgery or date of death from any cause, whichever came first||||U/L||Inter-Quartile Range|Median
1348379|NCT01822821|Secondary|Hospital Length of Stay|Evaluate whether IV acetaminophen hospital length of stay|end of surgery through hospital discharge||||days||Inter-Quartile Range|Median
1348380|NCT01822821|Secondary|Intensive Care Unit (ICU) Length of Stay|Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.|End of surgery through discharge from ICU||||hours||Inter-Quartile Range|Median
1348381|NCT01822821|Secondary|Duration of Mechanical Ventilation (Minutes)|Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.|End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.||||minutes||Inter-Quartile Range|Median
1348382|NCT01822821|Secondary|Postoperative Sedation|Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation.|Measured at 8, 16, and 24 hours after surgery|RASS scores were not collected at certain time points if patients were not available (e.g., patient was away at a test) or if staff were not available.|||units on a scale||Inter-Quartile Range|Median
1348383|NCT01822821|Secondary|Postoperative Nausea and Vomiting|Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.|End of surgery through 24 hours after surgery||||Participants|||Count of Participants
1348384|NCT01822821|Primary|Pain Intensity|Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).|End of surgery through 24 hours after surgery|All patients had at least one postoperative pain scores. Some patients did not have a pain score at particular time points if they were unavailable (e.g., at a test), unable to speak (e.g., intubated), asleep, or similar reasons. We report any available pain scores at each time they were collected.|||units on a scale||Standard Deviation|Mean
1348387|NCT01822756|Secondary|Percentage of Responders|Duration of response was measured as the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response.|Randomization to clinical cutoff 22Sept2015 (approx 244 days)|Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX|||Percentage of responders|||Number
1348388|NCT01822756|Secondary|Percentage of Participants With a Best Response by RECIST Criteria|"Best response was determined on the subject level using the highest overall response achieved post-baseline. In the case of stable disease (SD), measurements had to meet the SD criterion at least once after study entry at a minimum interval of 49 days. Subjects who failed to meet this criterion had best response of progressive disease (PD) if the next available RECIST evaluation after the initial scan indicated PD or not evaluable (NE) if no additional RECIST evaluations were available.~Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits."|every 2 cycles starting at Cycle 3 Day 1 up to approximately 4 to 6 months|Intent-to-Treat (ITT) Population - All subjects who received at least 1 dose of RUX|||percentage of participants|||Number
1348389|NCT01822756|Secondary|Clinical Activity as Measured by the Greatest Decrease in Tumor Burden Compared to Baseline.||Approximately 6 months|Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.||||||
1348390|NCT01822756|Secondary|Plasma Concentration of Tumor Specific Biomarkers and Cytokines Before and During Treatment.||Up to 6 months|Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted.Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.||||||
1348391|NCT01822756|Secondary|Plasma Concentrations Will be Used to Estimate Peak Plasma Concentration (Cmax) and Area Under the Plasma Concentration Curve (AUC).||Day 1 and Day 8|Further enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID – GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.||||||
1348392|NCT01822756|Primary|Percentage of Participants With Adverse Events That Are Defined as Dose Limiting Toxicities (DLTs)|Toxicities occurring during the first treatment cycle (Cycle 1) defined tolerability. Within each cohort, subjects were considered evaluable if they had received at least 40 of 56 planned doses of RUX during the 28-day surveillance period and received 2 of the 3 planned doses of chemotherapy (gemcitabine and/or gemcitabine and nab-paclitaxel) at the assigned dose level, or they had experienced a DLT.|Approximately 28 days|Safety population included all enrolled subjects who received at least 1 dose of RUX.|||percentage of participants|||Number
1348393|NCT01822691|Secondary|Number of Participants With Study Treatment Related Adverse Events (AEs)|Participants with treatment emergent Other (not including serious) Adverse events.|Up to 12 months|All participants|||participants|||Number
1348394|NCT01822691|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Participants with treatment emergent Grade 3 or 4 SAEs according to the NCI Common Terminology Criteria for Adverse Events Version (CTCAE) V4.0.|Up to 12 months|All participants|||participants|||Number
1348395|NCT01822691|Secondary|Median Overall Survival (OS)|Overall Survival (OS) defined as the time between the start of treatment and death. Treatment Duration is 17 weeks plus optional continuation phase. Study Duration is Treatment Phase followed by survival follow-up.|Up to 24 months|All participants|||months||Full Range|Median
1348396|NCT01822691|Secondary|Mean Time to Acute Myeloid Leukemia (AML) Progression|Disease progression defined as progression to int-2 or high risk International Prognostic Scoring System (IPSS) score or AML, based on World Health Organization (WHO) AML Criteria.|Up to 12 months|All participants|||months||Full Range|Mean
1348397|NCT01822691|Primary|Overall Response Rate (ORR)|ORR, measured by Response Criteria for Patients with Myelodysplastic Syndrome (MDS). According International Working Group (IWG) 2006 criteria (Cheson et al, 2006). Complete Remission (CR), Partial Remission (PR), Marrow CR, and Hematological Improvement (HI)(any cell line). Stable Disease (SD): Failure to achieve at least PR, but no evidence of progression for > 8 weeks.|Up to 12 months|All participants|||participants|||Number
1348398|NCT01822678|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score at the End of the 3-week Treatment Period, in Relation to the Baseline.|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 – 60) based on the patient’s subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1348399|NCT01822665|Secondary|Incidence of Fecal Occult Blood|The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood).|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Participants|||Number
1348400|NCT01822665|Secondary|Incidence of Gastric and/or Duodenal Mucosal Injury|Number of participants with endoscopy score equal to or more than 2 were determined based on Lanza score for both gastric and duodenal mucosal damage.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Participants|||Number
1348401|NCT01822665|Secondary|Duodenal Mucosal Damage (DMD) Scores|DMD was measured using a 5- point Lanza scale: 0 - normal duodenum; 1 - mucosal hemorrhages; 2 - one or two erosions; 3 - numerous areas of erosions and 4 - more than 10 erosions/ ulcers.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Score on a scale||Standard Deviation|Mean
1348402|NCT01822665|Secondary|GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Score on a scale||Standard Deviation|Mean
1348403|NCT01822665|Primary|Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|Intent to Treat (ITT) population: all participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Scores on a scale||Standard Deviation|Mean
1348404|NCT01822574|Secondary|Time to Complete Patella Resurfacing|Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. After the final resection, the timer was stopped.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)||||seconds||Standard Deviation|Mean
1348405|NCT01822574|Secondary|The Difference Between Surgeon Goal and Actual Resection Height|This outcome measure attempts to capture the most accurate method for obtaining a desired thickness. Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. The surgeon then stated their goal for post resection thickness, and these values were recorded. After the final resection, the timer was stopped. The ability to obtain the resection goal was independently assessed by a resident or fellow not involved in the resection. This was calculated by taking the difference between the surgeon's goal and the average thickness of the four quadrants measured by the resident or fellow.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)||||mm||Standard Deviation|Mean
1348406|NCT01822574|Primary|Mean Asymmetry of the Patella After Patella Resection|"Post-resection symmetry of the patella was independently assessed by a resident or fellow who was not involved in the resection. This was evaluated by dividing the patella into four equal quadrants and measuring the thickness in the center of each quadrant using a ring tipped or C-shaped caliper. The difference between the thickest and thinnest measurements of the patella was reported as the value of asymmetry."|approximate average surgery time of 3 hours||||mm||Standard Deviation|Mean
1348407|NCT01822561|Secondary|Change in Serum Potassium|Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.|Baseline and 1 month after treatment||||mEq/L||Standard Deviation|Mean
1348408|NCT01822561|Secondary|Change in Subfoveal Choroidal Thickness, Study Eye|Choroidal thickness can be measured using optical coherence tomography, and is known to be affected in patients with central serous chorioretinopathy. Thickness of the choroid under the fovea will be manually calculated in both the study eye.|Baseline and 1 month after treatment||||microns||Standard Deviation|Mean
1348409|NCT01822561|Secondary|Change in Best Corrected Visual Acuity|Visual acuity will be measured with standard eye charts, with manifest refraction at the initiation and conclusion of treatment. Although an important measure, this was not chosen as the primary outcome measure, as some patients with central serous chorioretinopathy may have a normal visual acuity when properly refracted (refraction can change with elevation of the macula by sub-retinal fluid)|Baseline and 1 month after treatment||||logMAR||Standard Deviation|Mean
1348410|NCT01822561|Secondary|Change in Macular Thickness|Automated software to calculate the thickness of the macula is standard on commercial OCT devices. Macular thickness before and after treatment will be assessed and compared.|Baseline and 1 month after treatment||||Microns||Standard Deviation|Mean
1348411|NCT01822561|Primary|Complete Resolution of Subretinal Fluid|Optical coherence tomography is an imaging technique capable of extremely high resolution (~5-7 microns) imaging of the macula, and is able to detect the presence and amount of subretinal fluid present, the key anatomic abnormality in Central Serous Chorioretinopathy|Baseline and 1 month after treatment||||participants|||Number
1348412|NCT01822548|Secondary|Absolute Change in HbA1C Compared to Baseline|The secondary endpoint was the change from baseline values of HbA1C in the Vildagliptin vs Glibenclamide arm at 4 and 12 months|V0 (randomization), V2 (month4), V4 (month 12).||||percentage||Inter-Quartile Range|Median
1348413|NCT01822548|Primary|Absolute Change in the Endothelial Progenitor Cell (EPC) Number|The study primary endpoint was the change from baseline values of the EPC number in the Vildagliptin vs Glibenclamide arm at 4 and 12 months.|V0, V2 (month 4), V4 (12 month)|Intention to treat (ITT) analysis|||EPC/10^6 cells||Inter-Quartile Range|Median
1348414|NCT01822535|Primary|Visit 2: Percent Change in Core Body Temperature With Midodrine|We will test the effects of midodrine on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) after exposure to cool temperatures (64°F) in persons with tetraplegia through comparing the percent changes in core body temperature during visit 1 to percent changes in core body temperature during visit 2.|Baseline, Baseline Post-midodrine, Up to 2 hours|Subjects analyzed were individuals who completed visit 1 of testing.|||Percent Change||Standard Deviation|Mean
1348415|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Delayed Recall|Cognitive performance will be evaluated using the Delayed Recall obtained using the Memory section of the Montreal Cognitive Assessment (MoCA). We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Scores are based on individual performance. All subjects are asked to remember two lists of five words (one list during baseline, and one list during cool Challenge). Lower scores indicate poorer performance, and a positive percent change in indicates improved cognitive performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.|||Percent Change||Standard Deviation|Mean
1348416|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Stroop Interference|Cognitive performance will be evaluated using the Interference T-Scores obtained using the Stroop Color and Word Test. We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.|||Percent Change||Standard Deviation|Mean
1348417|NCT01822535|Primary|Visit 1: Percent Change in Core Body Temperature|We will test the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) in persons with tetraplegia through comparing the percent changes in core body temperatures between groups from baseline to after cool exposure.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.|||Percent Change||Standard Deviation|Mean
1348418|NCT01822301|Secondary|Serial Computed Tomography Imaging|serial computed tomography images were collected to evaluate the volume of the defect|assessed at 7-21 days, 3 months and 9 months post op.||||volume, mL||Standard Deviation|Mean
1348419|NCT01822301|Primary|Facial Volume Score|the facial volume and appearance grading scale evaluates each aesthetic region in the face based on both physical examination and 3D photography by the clinician. scale ranges from 1-3 where a score of 1 indicates an obvious contour defect; 2 shows a noticeable improvement in contour but not sufficient to impart a normal appearance; 3 represents a normal appearance and/or close approximation with a normal uninjured contralateral structure.|assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op||||units on a scale||Standard Deviation|Mean
1348420|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 month post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
1348421|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|16 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
1348422|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
1350663|NCT01788163|Primary|Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status|The 95% Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
1348423|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
1348424|NCT01822223|Secondary|Grams of Force Needed to Disrupt Tissue Attachment to the Abutment|A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
1348425|NCT01822223|Primary|Number od Participants With Consistent Connective Tissue Integration at a Histologic Level|Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.|8 weeks post-abutment placement|The number of participants entered represents measured data.|||participants|||Number
1348426|NCT01822197|Secondary|Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0|Quality of life scoring at admission (Day 0) and post-treatment (Day 7) using the CF questionnaire-revised (CFQ-R) as a measure of health related quality of life. Minimally important changes in CFQ-R scoring have been reported at 5–8. Days 0 and 7 will be compared. Score range is 0 to 100. Lower scores indicate worse quality of life.|between day 0 and day 7 of hospitalization||||units on a scale||Standard Deviation|Mean
1348427|NCT01822197|Secondary|Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)|depressive symptom scoring at day 0 and day 7 using Quick Inventory of Depressive Symptomatology-clinician (QIDS-C) and Quick Inventory of Depressive Symptomatology self-report (QIDS-SR). Day 7 and Day 0 scores will be compared. Score range is 0 to 27. A QIDS score of less than 6 indicates no depression, 6–10 indicates mild depression, 11–15 moderate, 16–20 severe, and 21– 27 very severe depression.|between day 0 and day 7 of hospitalization||||units on a scale||Standard Deviation|Mean
1348428|NCT01822197|Primary|Length of Hospitalization|Length of stay will be measured in days|participants will be followed for the length of hospital stay, an average of 14 days||||days||Standard Deviation|Mean
1348429|NCT01822119|Other Pre-specified|Safety; Numbness|Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||participants|||Number
1348430|NCT01822119|Other Pre-specified|Safety; Pain|Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
1348431|NCT01822119|Other Pre-specified|Safety; Skin Evaluation|Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
1348432|NCT01822119|Other Pre-specified|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|Week 4, 6, 12 and 36|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||Newton||Standard Deviation|Mean
1348433|NCT01822119|Other Pre-specified|Feedback Measurement, BP110|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
1348434|NCT01822119|Other Pre-specified|Feedback Measurement, BP100|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
1348435|NCT01822119|Other Pre-specified|Choice of Sound Processor|Type of sound processors BP100 and BP110 attached to a soft band (subject preference)|Baseline|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||participants|||Number
1348436|NCT01822119|Other Pre-specified|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.|Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
1352739|NCT01763827|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Ful analysis set|||percent change||Inter-Quartile Range|Median
1348439|NCT01822119|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
1348440|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||Signal to noise ratio||Standard Deviation|Mean
1348441|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||Signal to noise ratio||Standard Deviation|Mean
1348442|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||% perception of presented words||Standard Deviation|Mean
1348443|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||% perception of presented words||Standard Deviation|Mean
1348444|NCT01822119|Secondary|Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
1348445|NCT01822119|Secondary|Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
1348446|NCT01822119|Secondary|Hearing Performance, Individual Frequencies|The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
1348447|NCT01822119|Primary|Hearing Performance, PTA4 at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery||||dB||Standard Deviation|Mean
1348448|NCT01822119|Primary|Hearing Performance, PTA4 at 12 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
1348449|NCT01821963|Secondary|Sustained Virological Response (SVR)|Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation. The treatment duration will be summarized with descriptive statistics. Additional analyses based on evaluable patients also conducted regarding the PTVR response rate. The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement. The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV. The SVR rate will be estimated, along with the exact 95% confident interval.|60 weeks|||||||
1348450|NCT01821963|Primary|Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant|"The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant.~Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate."|12 weeks post-transplant, up to 48 weeks for overall monitoring|Study terminated early with one participant. No analysis possible.||||||
1348451|NCT01821937|Secondary|Tmax,ss (After Multiple Dosing)|tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||hour||Geometric Coefficient of Variation|Geometric Mean
1348452|NCT01821937|Secondary|t(1/2,ss) (After Multiple Dosing)|t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||hour||Geometric Coefficient of Variation|Geometric Mean
1348453|NCT01821937|Secondary|AUC(0-tz) (After Single Dosing)|AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1348454|NCT01821937|Secondary|Cmax (After Single Dosing)|Cmax is defined as maximum measured concentration of Faldaprevir in plasma.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1348455|NCT01821937|Primary|AUC(Tau,ss) (After Multiple Dosing)|AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1348456|NCT01821937|Primary|Cmax,ss (After Multiple Dosing)|C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1348457|NCT01821859|Primary|Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease.|Using RECIST criteria, Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease.|6 months after start of dosing|||||||
1348458|NCT01821807|Secondary|Backache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of postdural puncture backache for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week||||participants|||Number
1348459|NCT01821807|Primary|Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of headache (PDPH) for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week||||participants|||Number
1348460|NCT01821534|Primary|Intra-rater Reliability Using a LFSC|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kappa statistics||95% Confidence Interval|Number
1348461|NCT01821534|Primary|Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kappa Statistics||95% Confidence Interval|Number
1348832|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV)|Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV)|Up to 1 year|Number available for analysis varied by infusion; 51-56 subjects|||titer||Standard Error|Mean
1348462|NCT01821534|Primary|Intra-rater Reliability Using a MMPS|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kappa statistics||95% Confidence Interval|Number
1348463|NCT01821534|Primary|Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall’s coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kendall's W||95% Confidence Interval|Number
1348464|NCT01821417|Secondary|Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device|Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.|1 year after placement|No data was collected. Previously entered data was entered incorrectly.||||||
1348465|NCT01821417|Secondary|Changes in Peri-implant Gingivitis Score|Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration|1 year after placement|No data was collected. Previously entered data was entered incorrectly.||||||
1348466|NCT01821417|Primary|Change in Millimeters of Bone Loss Surrounding the Implant Device|Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.|Implant insertion, 12 months post-insertion||||millimeters||Standard Deviation|Mean
1348467|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score|"The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.~Reason for the discrepancy of the LS mean (SE) for placebo in outcome 2 and outcome 9 is because the different MMRM model used in outcome 2 and outcome 9. The treatment groups included in the MMRM model for outcome 2 are placebo, lurasidone 20 mg, and lurasidone 80-160 mg. The treatment groups included in the MMRM model for outcome 9 are placebo, ENR lurasidone 80 mg, and ENR lurasidone 160 mg."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).|||units on a scale||Standard Error|Least Squares Mean
1348468|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).|||units on a scale||Standard Error|Least Squares Mean
1348469|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the Euroqol (EQ-5D) Index Score|The EQ-5D is a standardized measure of health state consisting of two parts: a) EQ-5D measuring mobility, self-care, pain/discomfort, usual activities, and anxiety/depression on a 0 2 scale with lower scores indicating improvement, and b) a 20-cm visual analogue scale (VAS) for health status rating on a 0-100 scale with higher scores indicating improvement. EQ-5D health states, defined by the EQ-5D descriptive system, may be converted into a single summary index (i.e. the EQ-5D index score) by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The EQ-5D Index scores ranged from -0.429 to 1.000. Generally higher observed EQ-5D Index scores indicate a better degree of health.|6 weeks|Intent to treat population: there are only 368 subjects who had at least one post-baseline Euroqol (EQ-5D) assessments.|||units on a scale||Standard Error|Least Squares Mean
1348470|NCT01821378|Secondary|Change From Week 2 to Week 6 for ENR Lurasidone 80 mg vs. ENR Lurasidone 160 mg in CGI-S Score|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|week 2 to week 6|ENR Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1348471|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the GAF Score|The GAF is a numeric scale (0 through 100) that measures a patient’s overall level of psychological, social, and occupation functioning. It is designed to guide clinicians through a methodical and comprehensive consideration of all aspects of a patient’s symptoms and functioning. The scale begins at 100 - superior functioning - to 0 - inadequate information.|6 Weeks|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1348472|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the MADRS Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).|||units on a scale||Standard Error|Least Squares Mean
1348473|NCT01821378|Secondary|Change From Week 2 to Week 6 for the ENR (Early Non-responders) Lurasidone 160mg Group vs the ENR (Early Non-responders) Lurasidone 80 mg Group in the Following: PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|week 2 to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population.|||units on a scale||Standard Error|Least Squares Mean
1348474|NCT01821378|Secondary|Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Score (PANSS) Total Score at Week 6|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|6 Weeks|Intent to treat population|||percentage of participants|||Number
1348475|NCT01821378|Secondary|Change From Baseline to Week 6 for the Lurasidone 20 mg, and Lurasidone 80 - 160 mg Groups Versus the Placebo Group in the Montgomery-Asberg Depression Rating Scale Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|Baseline to 6 Weeks|Intent to treat population - only 379 subjects had at least one post-baseline MADRS assessment.|||units on a scale||Standard Error|Least Squares Mean
1348476|NCT01821378|Secondary|Change in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The CGI-S is a clinician-rated assessment of the subject’s current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|Baseline to 6 Weeks|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1348477|NCT01821378|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to 6 Weeks|Intent to treat population - there was one subject randomized but not treated with study medication, therefore excluded from ITT population|||units on a scale||Standard Error|Least Squares Mean
1348478|NCT01821352|Primary|Change in Combined Circumference Measurement|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total combined body circumference measurement. Change in combined circumference measurement is calculated as the difference in circumference measurements from baseline to endpoint (4 weeks). A negative (-) change indicates a decrease in circumference and is positive for study success. A positive (+) change indicates an increase in circumference and is negative for study success.|Baseline and 4 Weeks||||inches||Standard Deviation|Mean
1348479|NCT01821352|Other Pre-specified|Subject Satisfaction With Procedure Outcome|"Subjects rated satisfaction with the outcome of the study procedures with respect to change in body shape on the following 5-point scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Not Very Satisfied, Not at All Satisfied.~Results are reported as the number of subjects in each treatment group who rated study outcome satisfaction as 'Very Satisfied' or 'Somewhat Satisfied'."|4 Weeks||||participants|||Number
1348480|NCT01821352|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total body circumference measurement. Change in combined circumference measurement from baseline to 4 weeks was calculated for each subject. Individual subject success was defined as a change of 3.0 inches or more in the combined circumference measurement across the evaluation period. A decrease in combined circumference measurement is positive for individual subject success. An increase in combined circumference measurement is negative for individual subject success. Overall study success was defined as a 40% or greater difference between the proportion of individual successes in each treatment group.|Baseline and 4 Weeks||||participants|||Number
1348481|NCT01821326|Primary|Rebleeding Rate||10 years||||participants|||Number
1348482|NCT01821118|Secondary|Number of Participants With Anti-PF-04360365 Antibodies|Blood samples were collected from participants who received active treatment to assess for presence/absence of anti-PF-04360365 antibodies.|Day 1 up to Day 240|All 24 participants who received PF-04360365 were included in this analysis.|||participants|||Number
1348483|NCT01821118|Secondary|Number of Participants With Significant Changes in Neurological Examination Results|A complete/full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station.|Baseline up till Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
1350664|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
1348484|NCT01821118|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination at Final Visit|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline up to Final Visit (Day 240)|All 36 participants who received study drug were included in the analysis.|||participants|||Number
1348485|NCT01821118|Secondary|Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS assessed whether participant responded yes to the following: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, self-injurious behavior with no suicidal intent."|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
1348486|NCT01821118|Secondary|Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or more than (>) 160 mm Hg; supine diastolic blood pressure (DBP) <50 mm Hg or >100 mm Hg; supine pulse rate of <60 beats per minute (bpm) or >100 bpm; maximum changes (increase or decrease) from baseline in supine SBP of >=20 mm Hg; maximum increase from baseline in supine DBP of >=20 mm Hg; and maximum decrease from baseline in supine DBP of >=10 mm Hg.|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
1348487|NCT01821118|Secondary|Number of Participants With Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function (including Hy's Law Criteria), renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
1348488|NCT01821118|Secondary|Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to Day 240|All 36 participants who received study drug were included in the AE summarization/analysis.|||participants|||Number
1348489|NCT01821118|Secondary|Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time|The Montreal Cognitive Assessment (MoCA) was used as a safety outcome measure to assess any changes in cognition. The MoCA is a 1-page 30-point test administered in approximately 10 minutes. The MoCA assessed short term memory, visuospatial abilities, multiple aspects of executive functions, attention, concentration, working memory, and language, as well as orientation to time and place. The total scale ranges from 0 to 30, with lower numbers indicating lower cognition performance.|Screening; Days 0, 1, 30, 60, 90, and 240|All 36 participants who received study treatment were included in the analysis. On Day 240, the number of evaluable participants in the placebo group was 11 instead of 12.|||units on a scale||Standard Deviation|Mean
1348490|NCT01821118|Secondary|Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities|"Brain sMRI abnormalities included cerebral edema and total infarcts (including cortical infarcts, white matter infarcts, and subcortical gray matter infarcts). Total infarcts is the total number of participants with at least 1 type of infarct."|Baseline/Screening, Day 15, Day 45, Day 90,|All 36 participants who received study treatment were analyzed for this endpoint.|||participants|||Number
1348491|NCT01821118|Secondary|Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)|Cerebral amyloid angiopathy (CAA) is caused by the progressive deposition of amyloid, predominantly AB40, within the walls of cerebral blood vessels with a predisposition for the vessels of the occipital lobe. As such, it is of interest to investigate the effect of PF-04360365 on AB concentrations. AB1-x and AB1-40 were investigated.|Baseline, 8 hours post dose on Day 1, Day 2, Day 30, 90 and 240|All 36 participants who received study treatment were included in this pharmacodynamic analysis. n=number of participants with measurable AB at the specified time point.|||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
1348492|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.|||seconds||90% Confidence Interval|Least Squares Mean
1348493|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.|||percent||90% Confidence Interval|Least Squares Mean
1348494|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.|||seconds||Standard Error|Geometric Mean
1348495|NCT01821118|Primary|Change From Baseline to Day 90 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at Day 90.|||percent/second||Standard Error|Geometric Mean
1348496|NCT01821118|Primary|Change From Baseline to Day 2 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked Functional Magnetic Resonance Imaging (fMRI)|Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.|Baseline, Day 2|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified region of interest (ROI) at Day 2.|||percent/second||Standard Error|Geometric Mean
1348497|NCT01821105|Secondary|Tumor Detection||At surgery||||lesions detected|||Number
1348498|NCT01821105|Secondary|All Adverse Events and Complications||up to 12 months||||patients|||Number
1348499|NCT01821105|Primary|Detection of Position Accuracy With Handheld Probe on Anatomical Location.||up to 12 months|number of tumor lesions detected by the probe|||lesions|Participants||Number
1348500|NCT01820754|Secondary|Patterns of Pathologic Response and Response Evaluation Criteria in Solid Tumor (RECIST) Response|"Within each category of RECIST response [partial response (PR), stable disease (SD), progressive disease (PD)], the number of subjects experiencing a pathologic complete response, pathologic partial response, and no pathologic response. RECIST evaluation will be conducted after completion of neoadjuvant therapy. Pathologic response will be evaluated in the resected tumor as follows:~No Pathologic Response: No evidence of cell death or tumor necrosis~Pathologic Partial Response: ≥30% tumor necrosis or cell death~Pathologic Complete Response: No evidence of viable tumor in surgical specimen (includes lung tissue and dissected lymph nodes)"|3 months|Note: pathological response was not captured for study participants. Therefore, the RECIST responses for patients at neoadjuvant month 3 are reported.|||Participants|||Count of Participants
1348501|NCT01820754|Secondary|Number of Subjects Experiencing a Metastasis by Site of Metastasis|Number of patients experiencing a metastasis between baseline and cycle 3|3 months|Intent to treat|||Participants|||Count of Participants
1348502|NCT01820754|Secondary|Median Disease-Free Survival|Disease-free survival (DFS) is defined as the time from surgical resection to disease recurrence (first disease recurrence or death, whichever comes first) after surgery. Patients alive who had not recurred as of the last follow-up had DFS censored at the last follow-up date. The Kaplan-Meier estimator will be used to estimate median DFS and its 95% confidence interval.|5 years|Patients were no longer followed for recurrence following surgery, so this outcome was not captured||||||
1348503|NCT01820754|Secondary|Feasibility and Tolerability of Neoadjuvant Chemotherapy Plus Ipilimumab and Surgery|"Number of subjects experiencing any of the criteria listed below:~Number of subjects receiving 3 doses of preoperative therapy~Number of subjects undergoing surgical exploration within 42 days of day 1 of the last cycle of neoadjuvant chemotherapy~Number of subjects undergoing lobectomy having surgery-related mortality~Number of subjects experiencing dose-limiting toxicity (DLT) during neoadjuvant therapy. DLT will be defined as treatment-related: ≥ Grade 4 hematologic toxicity (excluding neutropenia without fever or infection) or ≥ Grade 3 non-hematologic toxicity (excluding fatigue, nausea, vomiting, peripheral neuropathy, chemotherapy infusion reaction to carboplatin or paclitaxel)"|6 months|Intent to treat|||Participants|||Count of Participants
1348504|NCT01820754|Primary|Percentage of Subjects With Detectable Circulating T Cells After Treatment|"The primary objective of this trial is to determine the percentage of early stage lung cancer patients with detectable circulating T cells specific against tumor-associated antigen (TAA) after receiving platinum based neoadjuvant chemotherapy plus ipilimumab before surgery. Based on Duke intracellular cytokine staining (ICS) assessments over the past 8 years, detectable circulating T cells with specificity against TAA are defined as a CD8, CD4, and double positive (DP) (CD4+CD8+) lymphocyte percentage of ≥ 0.05% with each value also being at least twice that of the background unstimulated control value."|3 months|Intent to treat. Note that the 16.7% of patients that had detectable T-cell responses also had responses at baseline|||Percentage of participants|||Number
1348505|NCT01820585|Primary|Absolute Change From Baseline to Endpoint in Mean Pain|The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject’s diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject’s diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.|Baseline and 13 Weeks||||units on a scale||Standard Error|Least Squares Mean
1348506|NCT01820559|Primary|Absolute Change From Baseline in the Frequency of Migraine Attacks|The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.|4 weeks||||number of migraine attacks/participant||Standard Error|Least Squares Mean
1348507|NCT01820416|Primary|Change in Speech Perception|Hearing status, as assessed by the Connected Sentence Test (CST). Difference scores (post-test - pretest) are reported. The CST approximates everyday conversation. Scoring is based on the number of correctly repeated key words. Higher numbers indicate better scores. The minimum score is 0 (0%) and the maximum is 100 (100%). When comparing test-retest scores for an individual, Cox et al. (1988) suggest that changes of 15% or more (based on 100 key words) are indicative of significant changes. We subtracted the post-test from the pre-test, so that negative difference scores indicate worse performance, and positive difference scores indicate better performance. Difference scores with an absolute value smaller than 15 are interpreted as no significant change. In addition, pre- and post-test performance was assessed for groups using t-tests on the difference scores.|7-10 days after baseline measures recorded||||difference scores||Standard Deviation|Mean
1348508|NCT01820364|Secondary|Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways|Molecular status was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline and at progression with LGX818 single agent treatment|||||||
1348509|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study."|Entry to Part II of the study through study completion (approximately 22 days)|This analysis group is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.|||participants|||Number
1348510|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through completion of Part I of the study (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.|||participants|||Number
1348511|NCT01820364|Secondary|Plasma Concentration and Derived Pharmacokinetic Parameters|Assessment of pharmacokinetic (PK) parameters and plasma concentration was not done due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)|||||||
1348512|NCT01820364|Secondary|Incidence of Dose Limiting Toxicities (DLTs) (Part II)|Incidence of DLTs in Part II of the study was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)|||||||
1348513|NCT01820364|Primary|Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through study completion (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.|||participants|||Number
1348548|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Kinetics|Oxygen kinetics describes the dependence of respiration of isolated cells on oxygen partial pressure. The characteristics of oxygen uptake kinetics differ with intensity of exercise.|1 hour 40 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
1348514|NCT01819935|Secondary|Clinical Success|Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|"FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||percentage of participants|||Number
1348515|NCT01819935|Secondary|Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection|Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
1348516|NCT01819935|Secondary|Time to 30-day Re-admission|Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
1348517|NCT01819935|Secondary|Time to Intubation|Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
1348518|NCT01819935|Secondary|Time to Transfer Out From the Intensive Care Unit (ICU)|Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
1348519|NCT01819935|Secondary|Time to Discharge From the Hospital|Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Standard Deviation|Mean
1348520|NCT01819935|Secondary|Time to Therapy Change|Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
1348521|NCT01819935|Primary|Time to 30-day Mortality|Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
1348522|NCT01819922|Secondary|Plasma Metabolomic Profiles Before and Immediately Following Steady State and Incremental Exercise|Plasma metabolomic profiles before and immediately following steady state and incremental exercise were collected using vacutainer tube containing dipotassium ethylenediamine tetraacetic Acid (K2EDTA) were processed by the clinical site according to handling specifications.|1 hour pre-dose, 1 hour 20 minutes and 2 hours 10 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
1348523|NCT01819922|Secondary|Peak Diastolic Untwisting Rate|Diastolic untwisting is an important component of early diastolic left ventricular filling. Left ventricular diastolic function is determined by early diastolic relaxation and myocardial stiffness. Peak diastolic untwisting rate is defined as the rate of left ventricular relaxation. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
1348524|NCT01819922|Secondary|Diastolic Strain Rate|Diastolic strain rate was defined as the rate of percent change in all segments of left ventricular dimension in comparison to its original dimension. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
1348525|NCT01819922|Secondary|Change From Baseline in Early and Late Peak Velocity|Tissue velocities were measured off-line from 2D color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Change from baseline in early and late peak tissue velocities were reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||cm/sec||Standard Deviation|Mean
1348833|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B|Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348526|NCT01819922|Secondary|Early and Late Peak Tissue Velocity|Tissue velocities were measured off-line from two dimensional (2D) color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Early and late peak tissue velocities (EPV and LPV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||cm/sec||Standard Deviation|Mean
1348527|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral doppler time was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||msec||Standard Deviation|Mean
1348528|NCT01819922|Secondary|Trans-mitral Doppler: Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||msec||Standard Deviation|Mean
1348529|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral ration was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||ratio||Standard Deviation|Mean
1348530|NCT01819922|Secondary|Trans-mitral Doppler: Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||ratio||Standard Deviation|Mean
1348531|NCT01819922|Secondary|Change From Baseline in Systolic Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis. Change from baseline in systolic global strain rate was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change per second||Standard Deviation|Mean
1348532|NCT01819922|Secondary|Systolic Function: Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change per second||Standard Deviation|Mean
1348533|NCT01819922|Secondary|Systolic Function: Rotation/Torsion|Torsion is the twisting of an object due to an applied torque. It is expressed in newton metres. The left ventricle twists in systole storing potential energy and untwists (recoils) in diastole releasing the energy. Twist aids left ventricular ejection and untwist aids relaxation and ventricular filling. Therefore, rotation and torsion are important in cardiac mechanics. It was assessed by echocardiography using speckled tracking analysis .|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
1348534|NCT01819922|Secondary|Change From Baseline in Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing). Change from baseline in peak contractile velocity was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||cm/sec||Standard Deviation|Mean
1348535|NCT01819922|Secondary|Systolic Function: Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||centimeter per second (cm/sec)||Standard Deviation|Mean
1348536|NCT01819922|Secondary|Change From Baseline in Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant. Change from baseline in ejection fraction was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percentage of EDV||Standard Deviation|Mean
1348537|NCT01819922|Secondary|Systolic Function: Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percentage of EDV||Standard Deviation|Mean
1348538|NCT01819922|Secondary|Change From Baseline in Atrial Volumes|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes and end-diastole volumes were reported. Change from baseline in atrial volume was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
1348539|NCT01819922|Secondary|Cardiac Structure: Atrial Volume|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes (ESV) and end-diastole volumes (EDV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
1348540|NCT01819922|Secondary|Change From Baseline in Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area and end-systole area. It was assessed by echocardiography using 2-dimensional gray-scale imaging. Change from baseline in right ventricular dimension was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mm||Standard Deviation|Mean
1348541|NCT01819922|Secondary|Cardiac Structure: Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area (EDA) and end-systole area (ESA). It was assessed by echocardiography using 2-dimensional gray-scale imaging.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||millimetre (mm)||Standard Deviation|Mean
1348542|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Geometry|Left ventricular geometry was assessed by echocardiography using 2-dimensional gray-scale imaging. Relative wall thickness was the index of left ventricular geometry and defined as the sum of interventricular septal thickness (mm) and posterior wall thickness (mm) divided by LV internal end-diastolic diameter (mm).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
1348543|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Wall Thickness|Left ventricle is the chamber in the heart responsible for pumping blood to the rest of the body. Thickening of the lower chambers of left ventricular wall is also termed as ventricular hypertrophy. It was assessed by echocardiography using 2-dimensional gray-scale imaging; M-mode.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
1348544|NCT01819922|Secondary|Change From Baseline in the Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Change from baseline in left ventricular volume was reported using modified Simpson’s technique.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
1348545|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Left ventricular volume was reported using modified Simpson’s technique.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
1348546|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Physical Work Capacity at a Heart Rate of 130 Beats Per Minute (PWC 130)|Physical work capacity evaluates the capacity of an individual to perform physically demanding work tasks. PWC 130 was a simple sub-max exercise parameter that can be used as surrogate for fitness that was independent of metabolic cart measurements. Interventions that improve fitness improve the PWC 130.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||bpm||Standard Deviation|Mean
1348547|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Aerobic Efficiency|Aerobic efficiency was defined as volume of oxygen divided by work. This parameter was assessed during cardiovascular exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/watt||Standard Deviation|Mean
1348616|NCT01818596|Secondary|Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Week 24|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
1348549|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Pulse|Oxygen Pulse (VO2 /Heart Rate) was equal to stroke volume multiplied by oxygen extraction. This parameter was assessed during cardiopulmonary exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/beat||Standard Deviation|Mean
1348550|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Volume of Oxygen (VO2) at Anaerobic Threshold (AT)|VO2 at anaerobic threshold was widely recognized as a sub-max indicator of fitness. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
1348551|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope was also termed as ventilator efficiency. It was defined as the amount of minute ventilation required to eliminate 1 liter of carbon dioxide. The determinants of VE/VCO2 included fractional dead space and partial pressure of carbon dioxide. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||unitless||Standard Deviation|Mean
1348552|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Respiratory Exchange Ratio (RER)|RER was defined as the ratio between the amount of oxygen (O2) consumed and carbon dioxide (CO2) produced in one breath. The parameter was assessed during indirect measure of heat production (calorimetry).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||ratio||Standard Deviation|Mean
1348553|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2)|VO2 was the maximum rate of oxygen consumption as measured during incremental or prolonged, sub-maximal exercise. It reflects the aerobic physical fitness of the individual. It was assessed during indirect measure of heat production (calorimetry). The unit of measure is milliliter per kilogram per minute (mL/kg/min).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/kg/min||Standard Deviation|Mean
1348554|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters|Criteria for clinically significant ECG values included: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent (%) from baseline value of >200 msec and >=50 % for baseline value of <=200 msec, maximum QRS interval >=140 msec or maximum increase of >=50% for baseline value of >100 msec; QT interval corrected using the Fridericia formula (QTcF) 450-<480 msec, 480-<500, >=500 msec or increase of >45 msec or maximum increase of >=30 to <60 and >=60 msec for QT interval where, PR interval: interval between the start of the P wave and the start of the QRS complex corresponding to the time between the onset of atrial depolarization and onset of ventricular depolarization; QRS interval: time from electrocardiogram Q wave to the end of the T wave corresponding to ventricle depolarization, QTcF interval: time corresponding to the beginning of depolarization to repolarization of the ventricles.|Baseline up-to 3 hour post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
1348555|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data|Participants who met the pre-defined criteria for clinically significant cardiovascular events were reported. Criteria for clinically significant cardiovascular events: Blood pressure (BP) [supine systolic and sitting systolic BP (SBP): <90 millimeter of mercury (mm Hg), >=30 mmHg maximum increase and decrease from baseline in same posture; supine diastolic and sitting diastolic BP (DBP): <50 mm Hg, >=20 mmHg maximum increase and >=30 mmHg maximum decrease from baseline in same posture]; pulse rate: supine and sitting: <40 or >120 bpm.|Baseline up-to 3 hours post-dose|"Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment. Here, n specified the number of participants who were evaluable for the specified criteria."|||participants|||Number
1348556|NCT01819922|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant:Hematology (hemoglobin,hematocrit,red blood corpuscles [RBC] count:less than [<]0.8*lower limit of normal [LLN];platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN];white blood corpuscles [WBC]:<0.6*LLN or >1.5*ULN;lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN;basophils,eosinophil, monocytes:>1.2*ULN);Liver Function(aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase:>0.3*ULN;total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin:>1.5*ULN);Renal Function (blood urea nitrogen,creatinine:>1.3*ULN; uric acid:>1.2*ULN);Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride, calcium,bicarbonate:<0.9*LLN or >1.1*ULN; glucose fasting:<0.6*LLN or >1.5*ULN);Urinalysis (urine pH:>1.5*ULN or >4.5;urine glucose,ketones,proteins, nitrites, leukocyte esterase,blood/hemoglobin:greater than or equal to (>=)1;urine WBC and RBC,urine bacteria:>=20/High Power Field [HPF];epithelial cells:>=6/HPF).|Baseline up-to 3 hours post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
1348557|NCT01819922|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. Treatment-emergent were events between first dose of study drug and up to 5-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 5-10 days after last dose of study drug (up to 25 days)|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
1348558|NCT01819922|Primary|Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose|OUES was defined as an index of cardiopulmonary functional reserve that was based upon a submaximal exercise effort. OUES relates oxygen uptake to total ventilation during exercise.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/log10(L)||Standard Deviation|Mean
1348559|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change||Standard Deviation|Mean
1348560|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|1 hour 30 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change||Standard Deviation|Mean
1348561|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose|Full analysis set (FAS) was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 pharmacodynamic (PD) measurement.|||percent change||Standard Deviation|Mean
1348562|NCT01819883|Primary|Change in Thigh Muscle Cross-sectional Area|Change in thigh muscle cross-sectional area after biochemical control of acromegaly|Baseline and 3-month follow-up visit|20 subjects with active acromegaly completed a baseline visit. 16 subjects completed a follow-up visit after biochemical control of acromegaly had been achieved.|||Cm^2||Standard Deviation|Mean
1348563|NCT01819883|Primary|Change in Liver Fat|Change in intrahepatic fat after biochemical control of acromegaly|Baseline and 3-month follow-up visit|20 subjects with active acromegaly completed the baseline visit. 16 subjects completed the follow-up visit after biochemical control of acromegaly.|||Lipid/water ratio||Inter-Quartile Range|Median
1348564|NCT01819844|Secondary|Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.|The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout|12 hours||||percent absolute relative difference||Standard Deviation|Mean
1348565|NCT01819844|Secondary|Dextrose Dosing (g/kg)||12 hours||||grams/kilogram||Standard Deviation|Mean
1348566|NCT01819844|Secondary|Insulin Dosing (u/kg)||12 hours||||units/kilogram||Standard Deviation|Mean
1348567|NCT01819844|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl||12 hours||||percentage of time||Standard Deviation|Mean
1348568|NCT01819844|Secondary|Number of BG Events < 70 mg/dl as Determined by the CGM||12 hours||||events|||Number
1348569|NCT01819844|Secondary|Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm||12 hours||||mg/dl||Standard Deviation|Mean
1348570|NCT01819844|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl||12 hours||||percentage of time||Standard Deviation|Mean
1348571|NCT01819844|Secondary|Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements||12 hours||||Blood glucose values < 70 mg/dl|||Number
1348572|NCT01819844|Secondary|Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol||12 hours||||number of carbohydrate interventions|||Number
1348573|NCT01819844|Primary|Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.||12 hours||||mg/dl||Standard Deviation|Mean
1348574|NCT01819415|Secondary|Central Foveal Thickness|Measured with spectral-domain optical coherence tomography.|During at least 12 months of follow-up after vitreous biopsy.|||||||
1348575|NCT01819415|Primary|Lipidomics Profile||1 day (At the time of vitreous biopsy)|||||||
1348576|NCT01819415|Primary|Vitreal VEGF Levels.||1 day (At the time of vitreous biopsy)||||pg/ml|||Number
1348577|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version|The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|8-week follow-up||||units on a scale||Standard Deviation|Mean
1348578|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version|The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|8-week follow-up||||units on a scale||Standard Deviation|Mean
1348579|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version|The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)||||units on a scale||Standard Deviation|Mean
1348834|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - IgG|Summary of trough total IgG concentration prior to specified infusion|Up to 1 year||||mg/dL||Standard Error|Mean
1348580|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version|The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)||||units on a scale||Standard Deviation|Mean
1348581|NCT01819311|Primary|Clinician Rating on the Pediatric Anxiety Rating Scale|The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.|8-week follow-up||||units on a scale||Standard Deviation|Mean
1348582|NCT01819311|Primary|Clinician Rating on the Pediatric Anxiety Rating Scale|The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)||||units on a scale||Standard Deviation|Mean
1348583|NCT01819272|Secondary|Change in HbA1c (%) at 12 Weeks||Baseline and 12 weeks after the first dose of study medication|Week 12 Evaluable|||HbA1c (%)||Standard Error|Least Squares Mean
1348584|NCT01819272|Secondary|AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks||Baseline and 4 to 12 weeks after the first dose of study medication|Week 12 Evaluable|||mg/dL*week||Full Range|Median
1348585|NCT01819272|Primary|Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks||Baseline and 4 weeks after the first dose of study medication|Week 4 Evaluable|||mg/dL||Full Range|Median
1348586|NCT01819194|Primary|Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale|Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 – 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.|Post 3 days of wear|Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.|||eyes|Eyes||Number
1348587|NCT01819194|Primary|Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)|CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.|Post 3 days of wear|Subjects are those who were enrolled, randomized, and completed the study per protocol.|||units on a scale||Standard Deviation|Mean
1348588|NCT01819129|Secondary|Change From Baseline in Body Weight|For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|Week 0, week 26|This endpoint was summarized using the FAS. FAS included all randomized subjects.|||Kg||Standard Deviation|Mean
1348589|NCT01819129|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.|From Week 0 to Week 26.|This endpoint was summarized using the safety analysis set. Safety analysis set included all subjects receiving at least one dose of the test product or comparator. Subjects in the safety analysis set contributed to the evaluation ‘as treated’.|||Number of episodes|||Number
1348590|NCT01819129|Secondary|Change From Baseline in 2-hour PPG Increment (Meal Test)|For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|Week 0, week 26|This endpoint was summarized using the Full Analysis Set (FAS). FAS included all randomized subjects.|||mmol/L||Standard Deviation|Mean
1348591|NCT01819129|Primary|Change From Baseline in HbA1c|The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|Week 0, Week 26|The analysis of this efficacy endpoint was based on the full analysis set (FAS). FAS included all randomized subjects. The statistical evaluation of the FAS was to follow the intention-to-treat (ITT) principle and subjects contributed to the evaluation ‘as randomized’.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1348592|NCT01818752|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.~A serious adverse event is an adverse event that met 1 or more of the following criteria:~Death~Life-threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~Congenital anomaly/birth defect~Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.~Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship."|From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.|Safety population|||participants|||Number
1348617|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1348593|NCT01818752|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores|"The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.~It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL."|Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48|Intent-to treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
1348594|NCT01818752|Secondary|Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy|"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death."|From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.|The safety population included all randomized participants who received at least 1 dose of any study treatment (i.e., carfilzomib, bortezomib, melphalan, or prednisone).|||percentage of participants||95% Confidence Interval|Number
1348595|NCT01818752|Secondary|Complete Response Rate|"Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response.~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy."|Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
1348596|NCT01818752|Secondary|Overall Response Rate|"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
1348597|NCT01818752|Secondary|Overall Survival (OS)|"Overall survival (OS) was defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored on the date the patient was last known to be alive.~Median overall survival was estimated using the Kaplan-Meier method."|From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
1348598|NCT01818752|Primary|Progression-Free Survival (PFS)|"Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression.~Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner."|From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|The intent-to-treat population included all randomized participants.|||months||95% Confidence Interval|Median
1348599|NCT01818700|Secondary|Patients Global Impression og Change(PGIC)|Number of clinician with categorical change in overall status. PGIC: a participant-rated instrument assessing change in patient's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8 week|FAS set: 210. Missing values were imputed by LOCF.|||participants|||Number
1348600|NCT01818700|Secondary|Clinician Global Impression of Change(CGIC)|Number of clinician with categorical change in overall status. CGIC: a clinician-rated instrument assessing change in clinician's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8weeks|FAS set: 210. Missing values were imputed by LOCF.|||participants|||Number
1348601|NCT01818700|Secondary|Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline.|EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable).|8 week|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects were assessed EQ-VAS at visit 1(baseline), 153 Subjects were assessed EQ-VAS at visit 4(8week)|||units on a scale||Standard Deviation|Mean
1348618|NCT01818596|Secondary|Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Week 24|P1NP is a biomarker of bone turnover.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
1348602|NCT01818700|Secondary|Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline|"The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.~EQ-5D score = 1 - 0.081 - (relevant score by level for the relevant item)-0.269 (only if there is at least one level 3).~Table of scores by level for EQ-5D items mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.236)."|8 weeks|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects at Visit 1, baseline were assessed EQ-5D questionnaire, At visit 4(8weeks), 153 subjects were assessed EQ-5D questionnaire.|||units on a scale||Standard Deviation|Mean
1348603|NCT01818700|Secondary|Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline.|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 4/ET minus mean score at Baseline.|4 weeks|FAS set: 210. Missing values were imputed LOCF.|||units on a scale||Standard Deviation|Mean
1348604|NCT01818700|Primary|Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 8/ET minus mean score at Baseline.|8 weeks|FAS set: 210. Missing values were imputed by LOCF FAS included the data obtained from all subjects who had at least one dose of the study drug and had data of at least one primary efficacy endpoint assessment.|||units on a scale||Standard Deviation|Mean
1348605|NCT01818596|Secondary|PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study|TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide. AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants who were enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom the steady-state PK parameter (AUCtau) of TFV-DP was evaluable were analyzed.|||µmol*h/L||Standard Deviation|Mean
1348606|NCT01818596|Secondary|PK Parameter: t1/2 of TAF|t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1348607|NCT01818596|Secondary|PK Parameter: AUCtau of TAF|AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||ng*h/mL||Standard Deviation|Mean
1348608|NCT01818596|Secondary|PK Parameter: λz of TAF|λz is defined as the terminal elimination rate constant. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
1348609|NCT01818596|Secondary|PK Parameter: Tlast of TAF|Tlast is defined as the time of Clast. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1348610|NCT01818596|Secondary|PK Parameter: Clast of TAF|Clast is defined as the last observable concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1348611|NCT01818596|Secondary|PK Parameter: Tmax of TAF|Tmax is defined as the time of Cmax. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
1348612|NCT01818596|Secondary|Pharmacokinetic (PK) Parameter: Cmax of TAF|Cmax is defined as the maximum concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set (enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom steady-state PK parameters were available) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
1348613|NCT01818596|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1348614|NCT01818596|Secondary|Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities|"Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.~Data were collected for all participants through the Week 24 visit; additional data are included for participants who had passed the Week 24 visit."|Baseline to Week 24 Data Cut (average 42 weeks)|Safety Analysis Set|||percentage of participants|||Number
1348615|NCT01818596|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Week 24|Urine beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
1351248|NCT01781481|Primary|Correlations Between Pediatric INTERMED Domain Scores|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.|Pediatric INTERMED scores at time of study participation||||Correlation Coefficient|||Number
1348620|NCT01818596|Secondary|Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy|aGFR was directly measured using iohexol plasma clearance (CLiohexol).|Baseline; Week 2, 4, or 8; Week 24|Participants in the Pharmacodynamic (PD) Substudy Analysis Set (enrolled in the pharmacokinetic (PK)/PD substudy, received at least 1 dose of study drug, and had baseline and at least 1 postbaseline assessment for aGFR assessed by CLiohexol) with available data at the respective time point were analyzed.|||mL/min||Standard Deviation|Mean
1348621|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1348622|NCT01818596|Primary|Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24|eGFR is a measurement of the kidney's ability to filter blood.|Baseline; Week 24|Participants in the Safety Analysis Set (enrolled and received at least 1 dose of study drug) with available data at the respective time point were analyzed.|||mL/min||Inter-Quartile Range|Median
1348623|NCT01818414|Secondary|Complications|Incidence of surgical complications related to D&E|Day 1||||participants|||Number
1348624|NCT01818414|Secondary|Number of Providers With Overall Satisfaction|Provider overall satisfaction with cervical preparation|Day 1||||providers|||Number
1348625|NCT01818414|Secondary|Number of Participants With Postoperative Satisfaction|Patient postoperative satisfaction with cervical preparation method|Day 1||||participants|||Number
1348626|NCT01818414|Secondary|Patient Pain|"Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale (100-mm Visual Analogue Scale with 0 indicating no pain and 100 indicating worst pain in my life)"|Day 1||||mm||Standard Deviation|Mean
1348627|NCT01818414|Primary|Operative Time|The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E.|Day 1 of the study||||minutes||Standard Deviation|Mean
1348628|NCT01818336|Primary|Negative Predictive Value|The primary endpoint was the negative predictive value (NPV), which was estimated as p = percentage of n history-positive subjects with negative skin tests from the Penicillin Allergy Skin Test Kit (as confirmed with an overall negative result for the skin puncture/intradermal testing) who do not experience an IgE-dependent hypersensitivity reaction within 72 hours of the oral amoxicillin challenge.|72 hours|The Intent-to-Treat Population; all subjects with valid skin testing performed (ie, administered all components of the penicillin skin test kit and the histamine/control results were valid), who had negative intradermal skin tests with all 3 Kit reagents, and who received the oral amoxicillin challenge|||percentage of participants||95% Confidence Interval|Number
1348629|NCT01818297|Secondary|Worst Back Pain|Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1348630|NCT01818297|Secondary|Quality of Life: Mental|Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0).|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1348631|NCT01818297|Secondary|Quality of Life: Physical|Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0).|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1348632|NCT01818297|Secondary|Subject Satisfaction|Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis.|3 months|The analysis population includes all randomized subjects, with the exception of one subject in the Control group who did not have a satisfaction value. This subject was excluded from the analysis.|||Participants|||Count of Participants
1348633|NCT01818297|Secondary|Functional Disability|Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0).|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
1348634|NCT01818297|Primary|Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.|Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.|Baseline to 3 months||||Participants|||Count of Participants
1348635|NCT01818141|Primary|C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool|The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)|day 10-13||||Participants|||Count of Participants
1348638|NCT01818063|Secondary|Overall Clinical Response|The proportion of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]). Beta will be used as priors for combination regimens in calculating the posterior distribution of the PCR for each respective treatment group. Among subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.|Up to 3 years||2019-04-30|04/2019||||
1348639|NCT01818063|Primary|Count of Participants That Achieve Pathologic Complete Response (PCR)|PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.|36 months following surgery||||Participants|||Count of Participants
1348640|NCT01817907|Secondary|Arousal Threshold (cmH2O)|Subjects will have an epiglottic pressure catheter placed during their sleep studies. We will use the swing in the epiglottic pressure trace just prior to arousal to calculate the respiratory drive stimulus that is associated with an a respiratory induced arousal.|Participants will be assessed on 2 nights over an average period of 2 weeks.|two subjects were excluded from analysis because of excessive number of artifacts|||cmH2O||Standard Deviation|Mean
1348641|NCT01817907|Primary|Apnea-Hypopnea Index|The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).|Participants will be assessed on 2 nights over an average period of 2 weeks.|two subjects were excluded from analysis because of excessive number of artifacts|||events/hour||Standard Error|Mean
1348642|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmin)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1348643|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmax)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1348644|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (AUC(0-tau) )|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9.~*AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours .~Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1348645|NCT01817855|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)|Up to 24 days||||Participants|||Number
1348646|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Other Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|"All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of other symptoms, data of one participant each from the two groups are unavailable."|||Score on a scale||Standard Deviation|Mean
1348647|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Eye Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of eye symptoms, data of one participant each from the two groups are unavailable.|||Score on a scale||Standard Deviation|Mean
1348648|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Nose Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, data of one participant each from the two groups are unavailable.|||Score on a scale||Standard Deviation|Mean
1348649|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. 'Practical Problems' is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348650|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348651|NCT01817790|Secondary|Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. It measures five domains of functional impairment that are most important to subjects with SAR: practical problems, nasal symptoms, eye symptoms, activity limitations, and other symptoms. Participants scored their degree of impairment on a seven-point scale. (0 - 6). Mini RQLQ final score is the average of sub-scales, ranges from 0 (best possible outcome) to 6 (worst possible outcome).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, eye symptoms, and other symptoms, data of one participant each from the two groups are unavailable.|||Score on a scale||Standard Deviation|Mean
1348652|NCT01817790|Secondary|Mean Change in Objective Assessment of Conjunctival Redness|Conjunctival redness was evaluated as a clinical sign of SAR by the investigator. Scoring of severity was rated according to a 4-point scale: 0 = normal; 1 = Slightly pink; 2 = Moderately pink, some dilation; 3 = Intense red vessels, dilated.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348653|NCT01817790|Secondary|End-of-treatment Assessment of Response to Therapy for Ocular Symptoms|Overall response to therapy assessment was done using a 7-point categorical scale in which participants rated their response to therapy as follows: +3 = Significantly Improved; +2 = Moderately Improved; +1 = Mildly Improved; 0 = No Change; -1= Mildly Worse; -2 = Moderately Worse; -3 = Significantly Worse.|Day 14|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. In this outcome measure, in Fluticasone propionate group 313/314 participants, and in the placebo group 309/312 participants provided responses.|||Participants|||Number
1348654|NCT01817790|Secondary|Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)|The rNCSS is a participant perceived evaluation of overall congestion symptom severity (evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe) which was completed once in the evening (PM), and once in the morning (AM). rNCSS is defined as the average of the PM rNCSS and the AM rNCSS of the next day prior to AM dosing. The mean change from baseline in rNCSS (daily, AM, PM)was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348655|NCT01817790|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348656|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness|The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348657|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness|The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348658|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348659|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348660|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning|The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348661|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning|The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348662|NCT01817790|Secondary|Mean Change From Baseline in PM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348663|NCT01817790|Secondary|Mean Change From Baseline in AM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subjects completed rTOSS in the morning (AM score: prior to nasal spray use). The mean change from baseline in AM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348664|NCT01817790|Primary|Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)|The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject’s treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
1348665|NCT01817777|Secondary|Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up|The number of participants who voluntarily discontinued participation in the study at any time or who were withdrawn by the investigator for pre-defined reasons was summarized.|Week 28|Observational Population: all participants enrolled into the study. If an enrolled participant withdrew from the study prior to the Week 8 visit, all available data on the participant was included in the Observational Population.|||Participants|||Number
1348666|NCT01817777|Secondary|Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons|The number of particiapnts who missed days or doses of metformin was summarized.|Week 28|Per Protocol Population|||Participants|||Number
1348667|NCT01817777|Secondary|Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication|Number of participants who preferred their treatment regimens (interventional arm treatment [large or small pack metformin]) to how they previously took their medication are presented.|Week 28|Per Protocol Population|||Participants|||Number
1348668|NCT01817777|Secondary|Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes|The number of participants who visited a health care professional for diabetes management during the study was summarized.|Week 28|Per Protocol Population|||Participants|||Number
1348669|NCT01817777|Secondary|Number of Participants With Diabetes Disease Management Modifications|Throughout the duration of the study, participants remained on their recommended metformin dosing regimens, unless a change in metformin dose was prescribed by their physician. The number of participants who received additional diabetes therapy for the management of diabetes was summarized.|Week 28|Per Protocol Population|||Participants|||Number
1352740|NCT01763827|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
1348671|NCT01817777|Secondary|Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase|Compliance was estimated during the 8-week Observational Phase for usual metformin treatment. During the Observational Phase, compliance was measured by monitoring the number of pill dispensed and the return of the pills or tablets.|From enrollment to Week 8|Per Protocol Population|||Percent compliance||Standard Deviation|Mean
1348672|NCT01817777|Secondary|Mean Percent Compliance Throughout the Interventional Phase|Compliance for the study was estimated as a percentage, with the denominator defined as the number of pills dispensed by the pharmacist and the numerator defined as the number of pills taken, accounting for remaining pills at subsequent pharmacy visits.|From Randomization to Week 28|Per Protocol Population|||Percent compliance||Standard Deviation|Mean
1348673|NCT01817777|Primary|Change From Baseline in HbA1c Values at Week 28|HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device. HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28). The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated. However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power. Therefore, the final analyses were limited to descriptive statistics. The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).|Baseline (Week 8) and Week 28|Per Protocol Population: all participants in the Intent-to-Treat Population (randomly assigned to treatment and who received >= 1 dose [or any portion of a dose] of study medication and had an HbA1c test at Week 8) who did not have a protocol violation|||Percentage||Standard Deviation|Mean
1348674|NCT01817764|Secondary|Change From Baseline in Trough FEV1 on Day 85|Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing/11 and 12 hours after evening dosing on Day 84. Change from Baseline is calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1348675|NCT01817764|Primary|Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose of randomized study medication in the treatment period. Only par. with analyzable data at the indicated time point were assessed, but all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1348676|NCT01817725|Secondary|Anti-HBs Seropositivity||2 years||||Participants|||Count of Participants
1348677|NCT01817725|Primary|Change in HBsAg Levels From Baseline to 2 Years|The difference of HBsAg levels at the end of follow up (2 years) and baseline|2 years||||log IU/ml||Standard Deviation|Mean
1348678|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio Insulin||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
1348679|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio HgbA1c||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
1348680|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio MPO||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
1348681|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio IL-6||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
1348682|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio Liver Enzymes||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
1348683|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio hsCRP||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
1348684|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio Glucose||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
1348685|NCT01817491|Secondary|PB/AHA - Adjusted Mean Lipid Profile||Baseline, 4 weeks|Children and parents|||mg/dL||95% Confidence Interval|Mean
1348686|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference PAQ Children|PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.|Baseline, 4 weeks|Children|||units on a scale||95% Confidence Interval|Mean
1348687|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference Circumference||Baseline, 4 weeks|Children and Parents|||cm||95% Confidence Interval|Mean
1348688|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference Weight||Baseline, 4 weeks|Children and Parents|||kg||95% Confidence Interval|Mean
1348689|NCT01817491|Secondary|PB/AHA - Adjusted Mean BP||Baseline, 4 weeks|Children and parents|||ratio||95% Confidence Interval|Mean
1348690|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference BMI Z Score Children||Baseline, 4 weeks|Children|||Z score||95% Confidence Interval|Mean
1348691|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference BMI||Baseline, 4 weeks|Children and Parents|||percentile||95% Confidence Interval|Mean
1348692|NCT01817491|Primary|Change in Insulin||baseline, 4 weeks|Children and Parents|||uU/ml||Standard Deviation|Mean
1348693|NCT01817491|Primary|Change in HgbA1c (Hemoglobin A1c)||baseline, 4 weeks|Children and Parents|||percentage||Standard Deviation|Mean
1348694|NCT01817491|Primary|Change in MPO (Myeloperoxidase)||baseline, 4 weeks|Children and Parents|||pmol/L||Standard Deviation|Mean
1348695|NCT01817491|Primary|Change in IL-6 (Interleukin-6)||baseline, 4 weeks|Children and Parents|||pg/ml||Standard Deviation|Mean
1348696|NCT01817491|Primary|Change in Liver Enzymes||baseline, 4 weeks|Children and Parents|||U/L||Standard Deviation|Mean
1348704|NCT01817491|Primary|Children Change in BMI Z Score|Body mass index z-scores, also called BMI standard deviation (s.d.) scores, are measures of relative weight adjusted for child age and sex. Given a child's age, sex, BMI, and an appropriate reference standard, a BMI z-score (or its equivalent BMI-for-age percentile) can be determined. Negative BMI z-scores indicate a BMI that is lower than the population mean, while positive BMI scores indicate a value that is higher than the population mean. A decrease in the BMI z-score over time indicate a lowering of the BMI. Z-scores of 1.03 and 1.64 correspond to the 85th and 95th percentiles of BMI-for-age, which are the definitions of overweight and obesity in children.|baseline, 4 weeks|Children only|||Z Score||Standard Deviation|Mean
1348705|NCT01817491|Primary|Change in Body Mass Index BMI Percentile||baseline, 4 weeks|Children only|||BMI percentile||Standard Deviation|Mean
1348706|NCT01817374|Secondary|Pathology Residual Tumor|Pathology residual tumor measured in millimeters|6 months||||millimeters||Standard Deviation|Mean
1348707|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|6 months||||seconds||Standard Deviation|Mean
1348708|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|Week 4||||seconds||Standard Deviation|Mean
1348709|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|Week 2||||seconds||Standard Deviation|Mean
1348710|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|6 months||||millimeters||Standard Deviation|Mean
1348711|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|Week 4||||millimeters||Standard Deviation|Mean
1348712|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|Week 2||||millimeters||Standard Deviation|Mean
1348713|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|Baseline|1 subject did not complete this timepoint due to machine down|||seconds||Standard Deviation|Mean
1348714|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|Baseline (first visit)||||millimeters||Standard Deviation|Mean
1348715|NCT01816893|Secondary|Catecholamine Response to Lower-body Negative Pressure|Plasma norepinephrine response to lower body negative pressure (at the minus 40 mm Hg data point) on Day 3 about 16 to 20 hours after completion of the euglycemic or hypoglycemic clamp.|16 hours after euglycemic and hypoglycemic clamps|Of the 22 subjects who started the protocol, 20 completed both arms.|||nmol/L||Standard Deviation|Mean
1348716|NCT01816893|Secondary|Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity (MSNA), at rest and immediately after nitroprusside, was measured on Day 3 about 16 hours after the euglycemic and hypoglycemic clamps.|16 hours after euglycemic and hypoglycemic clamps|20 subjects completed both arms, but only 5 had the muscle sympathetic nerve activity outcome for both arms.|||bursts/ minute||Standard Deviation|Mean
1348717|NCT01816893|Primary|Change in Baroreflex Sensitivity|The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 [assessed 16 hours after the clamp] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 [baseline assessment on the day prior to the clamp]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.|16 hours after euglycemic and hypoglycemic clamps as compared to baseline|20 subjects completed both arms, but only 18 had the change in BRS outcome for both arms.|||ms/mmHg||Standard Deviation|Mean
1348718|NCT01816776|Secondary|Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months|Change in ESS = Month 6 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||units on a scale||95% Confidence Interval|Mean
1348719|NCT01816776|Secondary|Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months|Change in ODI4 = Month 6 index - Baseline index. The Oxygen Desaturation Index 4% is a measurement of the number of times per hour of sleep that the blood's oxygen level drops ≥4%.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
1348720|NCT01816776|Secondary|The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months|"The proportion of subjects with a moderate or marked improvement in the Patient Global Assessment from baseline to the 6 month visit"|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt. Note: 1 Control subject did not provide a response and is excluded from analysis."|||Participants|||Count of Participants
1348721|NCT01816776|Secondary|Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months|Change in REM = Month 6 percentage - Baseline percentage. Rapid Eye Movement (REM) is a sleep stage. A higher percentage of sleep in REM is a measure of better sleep quality.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||percentage of sleep||95% Confidence Interval|Mean
1350665|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
1348722|NCT01816776|Secondary|Arousal Index (ArI) Change From Baseline at 6 Months|Change in ArI = Month 6 index - Baseline index. The Arousal Index is a measurement used to indicate the number of times per hour of sleep that sleep is disrupted.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
1348723|NCT01816776|Secondary|Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months|Change in AHI = Month 6 index - Baseline index. The Apnea-Hypopnea Index is a measurement used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
1348724|NCT01816776|Secondary|Central Apnea Index (CAI) Change From Baseline at 6 Months|Change in CAI = Month 6 index - Baseline index. The central apnea index is a measurement used to indicate the severity of central sleep apnea. It is represented by the number of central apnea events per hour of sleep.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month polysomnogram (PSG) results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
1348725|NCT01816776|Primary|Freedom From Related Serious Adverse Events Within 12 Months|Freedom from serious adverse events (SAEs) associated with the implant procedure, the remede System, or the delivered therapy at 12 months post therapy initiation visit.|12 months|Intent-to-treat. The study protocol pre-specified that randomized groups be combined to assess freedom from related serious adverse events within 12 months.|||Participants|||Count of Participants
1348726|NCT01816776|Primary|The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI)|Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.|6 months|The population analyzed included all randomized participants who had a 6 month assessment. In addition, Treatment group subjects who did not have a 6 month assessment for reasons related to implant, device or delivered therapy were included as not achieving the endpoint.|||Participants|||Count of Participants
1348727|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Confusion Assessment Method (CAM) Diagnostic Algorithm. This binary tool identifies the presence or absence of delirium|Postoperative day 2||||participants|||Number
1348728|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.|Postoperative day 2||||units on a scale||Standard Deviation|Mean
1348729|NCT01816477|Secondary|Mean Daily Pain Score|Pain was measured by a visual analogue scale (VAS) with pre-set markings from 0 to 10, with 0 for no pain to 10 for the worst possible pain. On the case report form each day had 6 time categories: waking up in the morning, around lunch time, afternoon approximately 3-4 pm, dinner time, bedtime, and during the night time. Each day was averaged for each subject, then the values for each arm were averaged.|Days 1-7 post operation|The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q).|||units on a scale||Standard Deviation|Mean
1348730|NCT01816477|Primary|Use of Analgesic Narcotic|Postoperative analgesic used each day over 7 day postoperative period.|1-7 days post operation|The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q). The protocol had planned to use the area under the curve, but this was not analyzed in the published paper, due to the presence of missing data in the analgesic narcotic measurements.|||morphine milligram equivalents||Standard Deviation|Mean
1348731|NCT01816477|Primary|Hospital Length of Stay|Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.|Up to 11 days post operation||||days||Standard Deviation|Mean
1348732|NCT01816451|Primary|Fat Mass (%)|The subjects underwent a set of anthropometric assessments, which followed the norms of the International Society for Advancement of Kinanthropometry. The fat mass was calculated by percentage using the equation proposed by Jackson and Pollock (1978) from seven skinfold measurement. To measure the skinfolds, a Sanny Professional Skinfold Caliper was used.|Pre and post 14 weeks/46 sessions of training||||Fat Mass %||Standard Deviation|Mean
1348733|NCT01816451|Primary|Rate of Perceived Exertion (RPE) on Maximal Test|"The RPE was collected at maximal test (see description of test on outcome measure Maximal Oxygen Uptake). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 – 10) scale. Instructions for RPE were that “0” corresponds to rest, and “9 - 10” corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre and post 14 weeks/46 sessions of training||||units on a scale||Standard Deviation|Mean
1348734|NCT01816451|Primary|Body Mass (BM)|To measure body mass Filizola scales with a stadiometer was used.|Body Mass was collected pre and post training||||kg||Standard Deviation|Mean
1348735|NCT01816451|Primary|Blood Lactate Concentrations on Maximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8–22 millimole (mM). The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument’s instructions. The finger never touched the strip’s pad in order to exclude any possible interference due to the sweat. All [La] were collected by a single, experienced investigator.|Pre and post 14 weeks/46sessions on rest (5 min sitting position; before start the test); 1-3-5 min immediately after the end of the test (on sitting position).||||mmol*L^-1||Standard Deviation|Mean
1348736|NCT01816451|Secondary|Rate of Perceived Exertion (RPE) on Submaximal Test|"The RPE was collected at submaximal test (see description of test on outcome measure HR at submaximal test). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 – 10) scale. Instructions for RPE were that “0” corresponds to rest, and “9 - 10” corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training|The control group didn't do the submaximal test because it was done only for determine and adjusted the training intensities.|||units on a scale||Standard Deviation|Mean
1348737|NCT01816451|Secondary|Submaximal Velocity [Vsub]|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes. The test velocity should be clearly constant at the end of the test. Values of velocity were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the value of that speed has stabilized.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions of training|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [Vsub] during submaximal effort.|||km/h||Standard Deviation|Mean
1348738|NCT01816451|Secondary|Blood Lactate on Submaximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8–22 mM. The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood Measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument’s instructions we never let the finger touch the strip’s pad in order to exclude any possible interference due to the sweat.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46 sessions training: rest (5-min sitting; before start the test); 1-3-5 minutes immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [La] on rest and after submaximal effort during 14 weeks of training.|||mmol*L^-1||Standard Deviation|Mean
1348739|NCT01816451|Secondary|Heart Rate on Submaximal Test|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes.The test velocity should be clearly constant at the end of the test. Heart rate were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the HR values for training intensities.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training: rest (5-min sitting; before start the test); maximal during the test (maxHRsub); 60s-120s immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the training intensities during the 14 weeks.|||bpm||Standard Deviation|Mean
1348740|NCT01816451|Primary|Heart Rate on Maximal Test|The HR was collected pre and post training on maximal VO2 test. Initially, with the individual on the treadmill (Inbrasport Master Super, Porto Alegre, Brazil), electrodes (Micromed) were placed at the manubrium, right and left iliac crest for measured heart rate (HR) (derivation CM5) and were connected to an electromyography equipment (Micromed®). HR values were visualized through Elite software (Micromed Biotechnology, Brasilia, Brazil).|Pre and post 14 weeks at rest (5 min sitting; before start the test), during the test (to determine max), and 60s and 120s immediately after the end of the test (on sitting position)||||bpm||Standard Deviation|Mean
1348741|NCT01816451|Primary|Total Time Reaching on Maximal Test (tVO2max)|The criterion for determining the total time reaching in maximal VO2 test was associated with the time immediately preceding heart rate shown a reduction of five or more beats.|Pre and post 14 weeks/46 sessions of training||||minutes||Standard Deviation|Mean
1348742|NCT01816451|Primary|Absolute Maximal Oxygen Uptake|The absolute maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks||||L/min||Standard Deviation|Mean
1348743|NCT01816451|Primary|Relative Maximal Oxygen Uptake|The relative maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks||||mL/(kg*min)||Standard Deviation|Mean
1348744|NCT01816295|Secondary|Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)||Double Blind Baseline, Week 12, Open Label Baseline, Week 36|All participants with non-missing PSA result at the specified time point.|||participants|||Number
1348770|NCT01815918|Primary|Prothrombin Fragment (PF1.2), a Marker of Thrombin Generation|Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP|Baseline and up to 4 hours following surgery||||pMol/L||Standard Deviation|Mean
1348745|NCT01816295|Other Pre-specified|Change From Baseline in Total International Prostate Symptom Score (IPSS)|The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.|Baseline, Week 12, Week 36|All randomized participants with non-missing baseline IPSS measurement and at least one non-missing post baseline IPSS measurement. Missing data endpoints were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1348746|NCT01816295|Secondary|Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores|"The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with “10” corresponding to Full of Energy or Not Tired at All (The Tiredness scale was reverse-mapped, as it was collected with “10” corresponding to Extreme Tiredness). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low energy at baseline with non-missing HED questionnaire at baseline and at least one post baseline visit. Missing data endpoints were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1348747|NCT01816295|Secondary|Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores|"The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with 5 corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low sex drive at baseline with non-missing SAID Scale data at baseline and at least one post baseline visit. Missing data endpoints were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1348748|NCT01816295|Primary|Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12|Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).|Week 12|All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12.|||participants|||Number
1348749|NCT01816243|Secondary|Number of Participants With Participant's Global Assessment|Participants global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100% worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with participant's global assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study drug and had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) = participants who were evaluable for this measure and 'n' = participants who were evaluable for this measure at given time points.|||Participants|||Number
1348750|NCT01816243|Secondary|Number of Participants With Investigator's Global Assessment|Investigator would complete a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent (%) worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with Investigator's assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1348751|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 30|Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1348752|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 15|Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 15|Intent-to-treat (ITT) population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1348753|NCT01816074|Other Pre-specified|Parental and Family Functioning|The Dyadic Parent-Child Interaction Coding System (DPICS) will be used at baseline, week 8, and week 16 to provide an observational measure of positive and negative behaviors of the mother toward the child. Instances of positive (e.g. praise) and negative (e.g. criticism) behaviors are coded by study raters trained to reliability; scores range from 0 to no upper limit. Higher numbers indicate higher instances of the observed behaviors.|Assessed for the duration of the study participation, up to 16 weeks|6 participants were in the study before this assessment was added. 2 participants did not complete this assessment before they withdrew from the study. 3 participants withdrew from the study after the baseline visit (1 in the medication then medication arm after week 8, 1 in the Medication then BPT arm and 1 in BPT then BPT arm).|||instances observed||Standard Deviation|Mean
1348829|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348754|NCT01816074|Secondary|Maternal Behavioral Functioning|The Clinical Global Impression - Severity (CGI-S) scale will be used. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.|Mothers will be assessed for the duration of their participation, an expected average of 16 weeks.||||units on a scale||Standard Deviation|Mean
1348755|NCT01816074|Primary|Child Behavioral Functioning|Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.|Assessed for the duration of study participation, an expected average of 16 weeks.|7 participants had missing data, the Child CGI-S was not collected at any of the study visits for these participants because they completed the study before this measure was added to the protocol.|||units on a scale||Standard Deviation|Mean
1348756|NCT01816048|Primary|Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values|To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline.|Baseline and 3 months|The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.|||Participants|||Count of Participants
1348757|NCT01816048|Secondary|PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results||Baseline, one month, 2 months, 3 months|Data was not collected for this outcome measure.||||||
1348758|NCT01816048|Secondary|Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles|Change from baseline to one month and three month.|At baseline, one month, three months|Due to study closing early only 8 of planned 20 enrolled. All subjects completed one month of treatment; only 4 subjects completed the week 12 scan.|||Participants|||Count of Participants
1348759|NCT01816048|Secondary|Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)|Baseline compared to 12 weeks. Value at three months minus value at baseline.|At baseline and 12 weeks|Due to study closing early only 8 of 12 patients enrolled, and only 5 subjects obtained a week 12 CTC test.|||Participants|||Count of Participants
1348760|NCT01816048|Secondary|Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival.||Approximately 24 months|Due to study closing early, only 8 of planned 20 patients enrolled. Data for this endpoint was not obtained.||||||
1348761|NCT01816048|Secondary|Number of Participants With Changes in NaF PET/CT Results in Response to TAK700|This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline. Value at 12 weeks minus value at baseline.|At baseline and 12 weeks|Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the 8 subjects enrolled completed the week 12 scan.|||Participants|||Count of Participants
1348762|NCT01816048|Secondary|Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment|"Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline~PSA data was gathered at baseline and off treatment."|Up to 14 months|Due to study closing early only 8 of planned 20 patients enrolled.|||Participants|||Count of Participants
1348763|NCT01816048|Secondary|Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700|The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.|Up to 12 months||||participants|||Number
1348764|NCT01816048|Primary|Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate|Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline.|Baseline and 3 months|Study closed early and only 8 of planned 20 enrolled. Four subjects came off study prior to the three month time point.|||Participants|||Count of Participants
1348765|NCT01816048|Primary|Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values|To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline.|Baseline and 3 months|The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.|||Participants|||Count of Participants
1348766|NCT01815918|Secondary|Blinding Assessment|Throughout each patient's study participation, the patient and the data collector will be asked to guess their treatment status. This helps ascertain if there is an association between blinding status, treatment effect and the depression measure.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.||||||
1348767|NCT01815918|Secondary|Pain Scores and Opioid Consumption|Pain scores (rated on a scale of 0-10) will be taken throughout study participation. We will also record analgesic use to see if patients who received hydrocortisone needed fewer pain killers to control their postoperative pain.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.||||||
1348768|NCT01815918|Secondary|Hydrocortisone's Effect on Depression|Elevated IL-6 has been linked to post-operative depression following total knee replacement surgery. Patients will be administered the patient health questionnaire (PHQ-9) one month and 3 months following surgery to assess their well-being.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.||||||
1350666|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
1348771|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1348772|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1348773|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 (never bothered) to 100 (“always bothered”)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1348774|NCT01815840|Secondary|Percentage of Participants Experiencing Any Adverse Event||Up to 125 weeks|Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.|||percentage of participants|||Number
1348775|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 125|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1348776|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 97|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1348777|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 85|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1348778|NCT01815840|Secondary|Percentage of Participants With New Basal Cell Carcinomas at Week 73||Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percentage of participants|||Number
1348779|NCT01815840|Secondary|Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73||Baseline; Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.|||percentage of participants|||Number
1348780|NCT01815840|Secondary|Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73|The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
1348781|NCT01815840|Secondary|Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues|The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.|Baseline to Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1348782|NCT01815840|Primary|Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)|The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat analysis population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used.|||percent change||Standard Deviation|Mean
1348783|NCT01815736|Secondary|Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48|"The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream).~EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit."|Baseline; Week 48|"Participants in EFV-Related Symptom Analysis Set with available data were analyzed.~NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut"|||units on a scale||Standard Deviation|Mean
1348784|NCT01815736|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|"Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut"|||mg/dL||Standard Deviation|Mean
1348785|NCT01815736|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."|||percentage change||Standard Deviation|Mean
1352741|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Inter-Quartile Range|Median
1348786|NCT01815736|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."|||percentage change||Standard Deviation|Mean
1348787|NCT01815736|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|"Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.~New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."|||percentage of participants|||Number
1348788|NCT01815671|Secondary|Pain Related or Possibly Related to Colonoscopy Procedure|Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.|24 hours||||units on a scale||Standard Deviation|Mean
1348789|NCT01815671|Secondary|Time to Full Colonoscope Insertion||30 minutes||||minutes||Standard Deviation|Mean
1348790|NCT01815671|Primary|Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure|The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.|24 hours||||participants|||Number
1348791|NCT01815645|Secondary|Percentage Samples Submitted Negative for Marihuana Use|The proportion of samples testing negative for marijuana was determined by dividing the number of negative samples by the total number of expected samples (36 samples)|12 weeks||||percent of sample|percent of sample||Number
1348792|NCT01815645|Secondary|Percentage Samples Submitted Negative for Alcohol Use|Proportion of samples testing negative for alcohol use|12 weeks||||percent of sample|||Number
1348793|NCT01815645|Primary|Treatment Attendance|Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.|12 weeks|we compared group means for the total number of attended sessions.|||attended treatment sessions||Standard Deviation|Mean
1348794|NCT01815645|Primary|Number of Participants Completing 4, 8 and 12 Weeks of Treatment|Retention in treatment was quantified as the period elapsed between treatment intake and dropout (last appearance at the treatment facility) or the end of treatment. We present data on the number of participants retained in treatment in weeks 4, 8 and 12.|Number of participant retained in treatment at weeks 4, 8 and 12.||||number of participants|||Number
1348795|NCT01815645|Primary|Percentage Samples Submitted Negative for Crack Cocaine Use|Proportion of samples testing negative for Crack Cocaine use|12 weeks||||percentage of submitted negative samples|urine samples||Number
1348796|NCT01815645|Primary|Longest Duaration of Achieved Abstinance|Number of Participants with 4, 8 and 12 Weeks Continued Abstinence|12 weeks of treatment|Longest duaration of abstinance was determined by the highest amount of consecutive negative crack/cocaine samples submitted.|||number of participants|||Number
1348797|NCT01815515|Secondary|Sensitivity of Detection of New or Progression of Metastasis|"Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where equivocal lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed."|up to 1 year|Follow-up CIM was only available for 12 of the 17 participants. 92% of the lesions detected via 18F-DCFBC PET were marked as true positive.|||proportion of responsive lesions||95% Confidence Interval|Number
1348798|NCT01815515|Primary|Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)|Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.|24 Months|Combined Imaging Modality (CIM) refers to both CT and BS imaging. The total number of lesions analyzed by both CT and BS (CIM) are 235 (as represented by PET-positive and PET-negative, equivocal CIM). There is overlap in the number of lesions detected by conventional imaging modalities (ie: bone scan and computed tomography)|||lesions detected|Lesions||Number
1348799|NCT01815138|Other Pre-specified|Abdominal Distension|Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.|Within 2 weeks after trigger of oocyte maturation|Some patients did not complete the questionnaire. Abdominal distension analyzed|||Participants|||Count of Participants
1348800|NCT01815138|Other Pre-specified|Markers of Corpus Luteum Function|A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.|Within 60 days after trigger of oocyte maturation|Subset of women included in larger study, normal or high responders, peak estradiol level less than 4000 pg/mL on day of trigger.|||ng/mL||Standard Deviation|Mean
1348801|NCT01815138|Secondary|Ovarian Hyperstimulation Syndrome|Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.|Within 4 weeks of oocyte retrieval|Women with normal or high response to IVF, peak estradiol on day of trigger less than 4000 pg/mL.|||Participants|||Count of Participants
1348802|NCT01815138|Primary|Ongoing Pregnancy|Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .|Through time of study completion, on average 1-2years|per protocol analysis|||participants|||Number
1350667|NCT01788046|Secondary|Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase||Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
1348803|NCT01815099|Primary|Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.|The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.|Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session|rTMS treatment completers|||units on a scale||Standard Deviation|Mean
1348804|NCT01815008|Secondary|Changes in Platelet Transcriptome With Clopidogrel|Platelet transcriptome will be examined before and after 1 week of therapy with clopidogrel and differences will be determined|At baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding. Note that the top most gene (CNOT2) with the lowest p-value is being reported.|||FPKM||Standard Error|Mean
1348805|NCT01815008|Secondary|Difference in Collagen-induced Platelet Aggregation|Collagen-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At Baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.|||Difference in ohms (Post-Pre)||Standard Deviation|Mean
1348806|NCT01815008|Secondary|Difference in Arachidonic Acid-induced Platelet Aggregation|Arachidonic Acid-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At baseline and after 1-week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.|||Difference in ohms (Post-Pre)||Standard Deviation|Mean
1348807|NCT01815008|Primary|Difference in ADP-induced Platelet Aggregation|ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.|at baseline and at 1 week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.|||Difference in ohms (Post-Pre)||Standard Deviation|Mean
1348808|NCT01814878|Secondary|Patient Global Impression of Change (PGIC) Score|The PGIC was used to assess the degree of participant’s overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened).|Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
1348809|NCT01814878|Secondary|Dosage of Rescue Medication Administered Because of Insufficient Pain Relief|The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Milligram||Standard Deviation|Mean
1348810|NCT01814878|Secondary|Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief|The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Doses||Standard Deviation|Mean
1348811|NCT01814878|Secondary|Time to the First Rescue Medication Administered Because of Insufficient Pain Relief|The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular [directly into muscle] or intravenous injection [directly into vein]).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Minutes||Standard Deviation|Mean
1348812|NCT01814878|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)|The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <= 3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
1348830|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1352742|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
1348813|NCT01814878|Secondary|Total Pain Relief (TOTPAR) Score|Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
1348814|NCT01814878|Secondary|Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24|The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24.|Hour 6, 12, 24|The intent-to-treat population included all randomly assigned participants. Here, 'N' (number of participants analyzed) specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
1348815|NCT01814878|Primary|Sum of Pain Intensity Difference (SPID) at Hour 48|The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).|Hour 48|The per-protocol (PP) population included all randomly assigned participants who did not violate major eligibility criteria and whose SPID was calculated with actual measurements or adjusted values at all assessment time points.|||Units on scale||Standard Deviation|Mean
1348816|NCT01814800|Post-Hoc|Number of Participants With No Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection. Presenting the number of subjects with no (0) days lost from work/school/daycare due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||participants|||Number
1348817|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment - Per Subject-Year|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
1348818|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
1348819|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348820|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348821|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A|Up to 1 year|Number available for analysis varied by infusion; 51-54 subjects|||ug/mL||Standard Error|Mean
1348822|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348823|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348824|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348825|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F|Up to 1 year|Number available for analysis varied by infusion; 53-57 subjects|||ug/mL||Standard Error|Mean
1348826|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
1348827|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5|Up to 1 year|Number available for analysis varied by infusion; 52-58 subjects|||ug/mL||Standard Error|Mean
1348828|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4|Up to 1 year|Number available for analysis varied by infusion; 53-58 subjects|||ug/mL||Standard Error|Mean
1352743|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Inter-Quartile Range|Median
1348835|NCT01814800|Secondary|Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections|The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded)|Up to 1 year||||Linear Correlation Coefficients|||Number
1348836|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
1348837|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection)|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
1348838|NCT01814800|Secondary|Days of Hospitalization Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
1348839|NCT01814800|Secondary|Days of Hospitalization Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
1348840|NCT01814800|Secondary|Number of Hospitalizations Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Hospitalizations per subject-year|||Number
1348841|NCT01814800|Secondary|Number of Hospitalizations Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Number of hospitalizations|||Number
1348842|NCT01814800|Secondary|Time to Resolution of Infections - Infection Days Per Subject||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject||Standard Deviation|Mean
1348843|NCT01814800|Secondary|Time to Resolution of Infections - Duration Per Infection||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days||Standard Deviation|Mean
1348844|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Number of Visits per subject-year|||Number
1348845|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Number of Visits|||Number
1348846|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
1348847|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
1348848|NCT01814800|Secondary|Incidence of All Infections (Serious and Non-serious)||Up to 1 Year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||events per subject-year|||Number
1348849|NCT01814800|Primary|Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))|The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.|One year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||SBIs/subject/year|||Number
1348850|NCT01814787|Primary|Number of Children With Documented Risk Factors for Type 2 Diabetes|Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)|12 months||||Participants|||Count of Participants
1348851|NCT01814774|Secondary|Botulinum Toxin Inter-injection Interval|Injection-interval was the time in weeks between injections of botulinum toxin.|2 Years|All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.|||weeks||Standard Deviation|Mean
1348852|NCT01814774|Secondary|Number of Participants With Adverse Events|An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.|2 Years|Safety population included all participants who received at least one dose of botulinum toxin.|||participants|||Number
1348853|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Blepharospasm|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.|||units per patient per year||95% Confidence Interval|Mean
1348854|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Cervical Dystonia|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.|||units per patient per year||95% Confidence Interval|Mean
1348855|NCT01814761|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Percentage Change||95% Confidence Interval|Mean
1348879|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
1348856|NCT01814761|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Patients|||Number
1348857|NCT01814761|Secondary|Percentage of Patients Who Discontinue Due to an Adverse Event|An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Percentage of Patients|||Number
1348858|NCT01814761|Secondary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1348859|NCT01814748|Secondary|Percentage of Participants Who Required Glycemic Rescue by Week 24|"Participants exceeding pre-specified glycemic thresholds after starting the double-blind treatment period may have received rescue therapy (per protocol) with open-label metformin initiated by the investigator.~This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|All randomized participants.|||Percentage of participants|||Number
1348860|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% (48 mmol/Mol) at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (cLDA). Within-group CIs were calculated via the Wilson score method.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||Percentage of participants||95% Confidence Interval|Number
1348861|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (constrained longitudinal data analysis [cLDA] model). Within-group confidence intervals (CIs) were calculated via the Wilson score method.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||Percentage of participants||95% Confidence Interval|Number
1348862|NCT01814748|Secondary|Change in Baseline in FPG at Week 24|"Blood glucose was measured on a fasting basis.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1348863|NCT01814748|Secondary|Change From Baseline in 2-hr PMG at Week 24|"Blood glucose was measured 120 minutes from start of meal.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1348864|NCT01814748|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.~The safety database was analyzed in a standard fashion in the APaT population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|APaT population included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1348865|NCT01814748|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.~The safety database was analyzed in a standard fashion in the all participants as treated (APaT) population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 27|APaT population included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1348866|NCT01814748|Primary|Change From Baseline in A1C at Week 24|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|Full analysis set (FAS) population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||Percent||95% Confidence Interval|Least Squares Mean
1348867|NCT01814722|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a 10-question dermatology-specific QOL questionnaire, which is calculated by summing the score of each question, resulting in a maximum of 30, and a minimum of 0. Higher scores mean the QOL is more impaired.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
1348868|NCT01814722|Secondary|Change From Baseline in HIV Symptom Index (HIV-SI)|HIV-SI measures the frequency and level of bothersome HIV and HIV treatment-related symptoms, including nervous symptoms (dizziness, somnolence, trouble remembering), gastrointestinal symptoms (nausea, gas/bloating, diarrhea) and pain (hand/foot, muscle/joint). The 20-item questionnaire asks whether respondents experienced any one of these symptoms within the past 4 weeks, and if they did, what the relative level of bother for each symptom was, based on a 5-point Likert scale. The maximum sum of scores is 80; the minimum is 0; with a higher score indicating greater symptom distress.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
1348869|NCT01814722|Secondary|Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)|DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
1348870|NCT01814722|Primary|Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores|The MOS-HIV scale is a 35-item measure of health related quality of life (QOL) questionnaire which assesses 10 dimensions of health (general health perceptions, pain, physical functioning, role functioning, social functioning, mental health, energy/fatifue, cognitive function, health distress and QOL), as well as a single item to assess health transition. In addition to these subscales, a Physical Health Summary score (PHS) and a Mental Health Summary score (MHS) is calculated using a method where the summary scores are transformed to a standardized scale with a norm of 50 and a standard deviation of 10 in the sample in which the summary scores were developed. The subscales of the MOS-HIV are scored as summed rating scales ranging from a minimum of 0, to a maximum of 100, where higher scores indicate better health.|Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
1348871|NCT01814696|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score|"Health-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire consists of 21 items that assess the impact of HF and HF treatment on key physical, emotional, and social dimensions of a patient’s life during the past four weeks. Responses are coded from 0 = does not apply and 1 = very little to 5 = very much.~A higher score represents a greater negative HR-related impact on quality of life."|Baseline, end 3 months||||units on a scale||Standard Deviation|Mean
1348872|NCT01814696|Secondary|Hospitalization, Length of Stay (Days)||3 months|Intention to treat analysis.|||days||Standard Deviation|Mean
1348873|NCT01814696|Secondary|Number of Hospitalization Visits.||3 months|Intention to treat analysis.|||participants|||Number
1348874|NCT01814696|Secondary|Number of Emergency Department (ED) Visits.||3 months|Intention to treat analysis.|||participants|||Number
1348875|NCT01814696|Secondary|Number of Participants With 1 or More Hospitalizations.||3 months|Intention to treat analysis.|||participants|||Number
1348876|NCT01814696|Secondary|Number of Participants With 1 or More Emergency Department (ED) Visits.||3 months|Intention to treat analysis.|||participants|||Number
1348877|NCT01814696|Primary|Morisky Medication Adherence Survey, 8-Items (MMAS-8)|Subject reported medication adherence. The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. Responses are summed from the 8-items to yield 3 categories of adherence: 0 = high adherence, 1-2 = medium adherence, and 3-8 = low adherence.|3 months|Participants who completed questions on enrollment and closeout survey.|||participants|||Number
1348878|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
1348880|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1 and had data at the noted time point|||Percentage of Subjects|||Number
1348881|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
1348882|NCT01814670|Primary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 30|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
1348883|NCT01814553|Secondary|PFS|"Progression-free survival (PFS). PFS was defined as the time from the start of treatment to an event occurred. In the analyses for the PFS endpoint, an event was defined as disease progression or death, whichever occurred earlier. Data for patients who did not die or progress during the trial were censored at the time of afatinib discontinuation or transition to commercially available afatinib. Median PFS is estimated using Kaplan-Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)."|Every 08 weeks during the first 6 months of treatment, and every 12 weeks thereafter until the end of treatment.|Treated Set|||Months||95% Confidence Interval|Median
1348884|NCT01814553|Secondary|Changes in Intensity of Diarrhea Over Time|Percentage of participants with grade 2 or higher diarrhea each week for the first 3 cycles of afatinib treatment|Up to 12 weeks (equivalent to 3 courses)|Treated set|||Percentage of participants|||Number
1348885|NCT01814553|Secondary|Duration of First Episode of Diarrhea Grade 2 or Higher|"Duration of first episode of diarrhea grade 2 or higher.~Please note that the nine patients experienced diarrhea episodes that were not managed according to the protocol specified afatinib treatment interruptions and dose reductions. No patients were excluded from the primary analysis."|From first drug administration until end of third treatment course, up to 84 days.|Treated set|||days||Standard Deviation|Mean
1348886|NCT01814553|Secondary|Time to Initial Onset of Diarrhea Grade 2 or Higher|Time to initial onset of diarrhea grade 2 or higher|From first drug administration until end of third treatment course, up to 84 days.|Treated set|||days||Standard Deviation|Mean
1348887|NCT01814553|Primary|Occurence of CTCAE Grade >= 2 Diarrhea|Overall incidence of patients who experienced diarrhea during the first three courses of afatinib treatment.|From first drug administration until 28 days after the end of third treatment course, up to 84 days.|Treated set|||Percentage of participants|||Number
1348888|NCT01814397|Other Pre-specified|Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy|Estradiol is being assessed using an ultrasensitive gas chromatography tandem mass spectroscopy-based assay. The lower limit of detection of the assay is 0.625 pg/ml. For patients whose serum estradiol concentrations were below the lower limit of detection, the value of 0.625 pg/ml was used to calculate the mean estradiol concentration and standard deviation at both baseline and 3 months.|Baseline, 3 months||||pg/ml||Standard Deviation|Mean
1348889|NCT01814397|Other Pre-specified|Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment|Patients completed 4 measures at baseline, before aromatase inhibitor therapy initiation. (1) Depression: Center for Epidemiologic Studies-Depression, scores 0-60, higher scores reflect more depression. (2) Pain: 7 day Pain Diary, scores 0-10, higher scores reflect more pain. (3) Fatigue: Multidimensional Fatigue Inventory, scores 4-20, higher scores reflect more fatigue. (4) Sleep: Medical Outcomes Study-Sleep, scores 0-100, higher scores reflect worse sleep. Persistence with aromatase inhibitor therapy was assessed at the 6 month timepoint. Mean baseline values for each measure were calculated for the cohort that persisted with aromatase inhibitor therapy and the cohort that was non-persistent.|Baseline patient-reported outcomes measures, 6 month persistence with therapy||||units on a scale||Standard Deviation|Mean
1348890|NCT01814397|Secondary|Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months|To assess conditioned pain modulation, pressure equivalent to the patient's Pain50 was applied to the non-dominant thumbnail for 30 seconds (test stimulus), and the patient rated the intensity of the pressure on a 0-100 pain scale at 10 second intervals. Ten minutes later pressure (conditioning stimulus) was continuously applied to the dominant thumbnail for 60 seconds at the same Pain50 intensity. After 30 seconds, the test stimulus was again applied to the non-dominant thumbnail for 30 seconds and the patient rated the intensity every 10 seconds. Conditioned pain modulation magnitude was calculated as the difference (second minus first) in the mean of the 3 pain ratings to the test stimulus applied prior to and during the conditioning stimulus. Conditioned pain modulation was assessed at baseline, 3 months, and 6 months. Change over that time period was assessed. Higher conditioned pain modulation values indicate less efficient conditioned pain modulation.|Baseline, 3 months, 6 months||||units on a scale (0-100 pain scale)||Standard Deviation|Mean
1348891|NCT01814397|Primary|Mean Pain50 Assessed at Baseline, 3 Months and 6 Months|Patients rated the intensity of each pressure sensation using a 0 to 100 numerical rating scale (0 = no pain, 100 = worst pain imaginable). Pain50 was defined as the amount of applied pressure in kilograms per square centimeter that evoked a pain intensity rating of 50 out of 100. Pain50 was assessed at baseline, 3 months, and 6 months. Change in Pain50 with estrogen depletion was determined.|Baseline, 3 months, 6 months||||kg/cm^2||Standard Deviation|Mean
1348892|NCT01814332|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Baseline, Week 6||||participants|||Number
1348893|NCT01814332|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6||||Score on a scale||Standard Deviation|Mean
1348894|NCT01814332|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured as having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6||||participants|||Number
1348895|NCT01814332|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, 6 weeks|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.|||score on a scale||Standard Deviation|Mean
1348896|NCT01814241|Other Pre-specified|Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge|The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut|44 weeks|Blood work was not able to be obtained from 1 of 16 evaluable subjects|||mg/dL of IgG4||Full Range|Median
1348897|NCT01814241|Other Pre-specified|Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge|The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE)|44 weeks|Blood work was not able to be obtained from 1 of 16 evaluable subjects|||kU/L of peanut-specific IgE||Full Range|Median
1348898|NCT01814241|Other Pre-specified|Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut|Allergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period.|44 weeks||||mm||Full Range|Mean
1348899|NCT01814241|Secondary|Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped|The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.|4 weeks||||percentage of participants|||Number
1348900|NCT01814241|Primary|Percentage of Subjects Who Develop Desensitization|The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.|40 weeks||||percentage of participants|||Number
1348901|NCT01814137|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One subject in each arm did not have FPG values from week 0.|||mmol/L||Standard Deviation|Mean
1348902|NCT01814137|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.|||episodes|||Number
1348903|NCT01814137|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"Confirmed hypoglycaemic episodes were defined as episodes that are either:~severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or~biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.|||episodes|||Number
1348904|NCT01814137|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.|During 26 weeks of treatment|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product.|||number of events|||Number
1348905|NCT01814137|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1348906|NCT01814046|Other Pre-specified|Count of Participants With Changes in Visual Symptoms|Visual symptoms (e.g., blurred) were evaluated and if changes had occurred from baseline, i.e. in visual acuity, an ophthalmologic consult was performed.|6 weeks (+/- 2 weeks)|One out of 24 subjects had blurred vision.|||Participants|||Count of Participants
1348907|NCT01814046|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|46 months and 12 days||||Participants|||Count of Participants
1348908|NCT01814046|Primary|Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR))|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|approximately 3 years||||percentage of participants||95% Confidence Interval|Number
1348909|NCT01813890|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||Percentage of participants|||Number
1348910|NCT01813890|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
1348911|NCT01813890|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
1348912|NCT01813890|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
1348913|NCT01813890|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.|||Percentage of Participants|||Number
1348914|NCT01813890|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.|||Percentage of Participants|||Number
1348915|NCT01813890|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|up to 48 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.|||Hours||Inter-Quartile Range|Median
1348916|NCT01813890|Primary|Sum of Pain Intensity Difference (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
1348941|NCT01813474|Secondary|AUC Following Single Dosing||Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose|Dose escalation part only. One participant in 200 mg bid had no AUC data because AUC was not calculable for this participant.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1348942|NCT01813474|Secondary|Tmax Following Multiple Dosing||Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose|Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.|||hour||Full Range|Median
1348917|NCT01813721|Secondary|Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP|At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant’s medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1.|At Baseline and at enrolment, prior to chemotherapy initiation.|Primary analysis set, participants with investigator-assessed FN risk at or above the investigator FN-risk intervention threshold|||percentage of participants|||Number
1348918|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348919|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348920|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348921|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348922|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only includes subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348923|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348924|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348943|NCT01813474|Secondary|Tmax Following Single Dosing||Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose|Dose escalation part only|||hour||Full Range|Median
1348925|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348926|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348927|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348928|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348929|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348930|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; subgroup analyses were only performed on subgroups (countries) with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
1348931|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1348932|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348944|NCT01813474|Secondary|Cmax Following Multiple Dosing||Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose|Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1348933|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348934|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348935|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348936|NCT01813721|Primary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1348937|NCT01813721|Primary|Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|At enrolment, prior to chemotherapy initiation|Primary analysis set which consists of all participants who satisfied the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment.|||percentage of participants||95% Confidence Interval|Number
1348938|NCT01813721|Primary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348939|NCT01813721|Primary|Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|Baseline (prior to participant enrolment)|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).|||percentage of investigators|Investigators|95% Confidence Interval|Number
1348940|NCT01813474|Secondary|AUC at Steady State Following Multiple Dosing||Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose|Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1348946|NCT01813474|Secondary|Number of Participants With Dose Limiting Toxicities|Dose Limiting Toxicities were defined as study specific events that is determined to be possibly or probably related to olaparib (as determined by the investigator) and occurring during the first cycle of treatment (28 days after the first dose), irrespective of whether the toxicity resolved.|From the start dose to 28 days after the first dose of study drug|All patients in only the dose escalation part who received olaparib and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.|||Participants|||Number
1348947|NCT01813474|Primary|Number of Participants With Adverse Events|An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.|From the start dose to 30 days after the last dose of study drug||||Participants|||Number
1348948|NCT01813422|Secondary|Percentage of Participants With Regression in Total Atheroma Volume|"Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.~Regression in TAV was defined as any reduction from baseline in TAV."|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||percentage of participants||95% Confidence Interval|Number
1348949|NCT01813422|Secondary|Percentage of Participants With Regression in Percent Atheroma Volume|"Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.~Regression in PAV was defined as any reduction from baseline in PAV."|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||percentage of participants||95% Confidence Interval|Number
1348950|NCT01813422|Secondary|Change From Baseline in Total Atheroma Volume at Week 78|Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||mm³||Standard Error|Least Squares Mean
1348951|NCT01813422|Primary|Change From Baseline in Percent Atheroma Volume at Week 78|Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||percent atheroma volume||Standard Error|Least Squares Mean
1348952|NCT01813110|Secondary|Interleukin-6 (IL-6)|Change in the plasma concentration of TNF-α at 2 hours post endotoxin administration, after each 8 week intervention|2 hours post endotoxin administration, following each 8 week intervention||||pg/mL||Standard Error|Mean
1348953|NCT01813110|Secondary|Tumor Necrosis Factor-α (TNF-α)|Change in the plasma concentration of TNF-α at 2 hours post endotoxin administration, after each 8 week intervention|2 hours post endotoxin administration, following each 8 week intervention||||pg/mL||Standard Error|Mean
1348954|NCT01813110|Primary|Change in C Reactive Protein (CRP)|Change in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention|24 hours post endotoxin administration, following each 8 week intervention||||mg/L||Standard Error|Mean
1348955|NCT01813019|Secondary|Y-BOCS Reduction in Total Score From Baseline|If a subject demonstrates at least 25% reduction in total Y-BOCS from Baseline then they will be classed as a responder whereas if a subject has a reduction in Y-BOCS of less than 25% then they will be categorized as a nonresponder.|16 weeks|The study was terminated due to an interim analysis of the primary efficacy outcome. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective therefore secondary objective was not measured.||||||
1348956|NCT01813019|Primary|Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing).|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0–7 = sub-clinical 8–15 = mild 16–23 = moderate 24–31 = severe 32–40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change."|baseline, week 17|Pharmacodynamics (PD) analysis set only participants that were analyzed at baseline and Week 17. Positive change from baseline indicates a decrease in symptom severity|||Scores on a scale||Standard Error|Least Squares Mean
1348957|NCT01812837|Primary|Actinic Keratoses Reduction Percent||one month after treatment||||percentage||Standard Deviation|Mean
1348958|NCT01812707|Secondary|Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of ApoB/ApoA-1 ratio analyzed.|||ratio||Standard Error|Least Squares Mean
1352744|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
1348959|NCT01812707|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of Fasting Triglycerides and Lipoprotein (a) analyzed.|||percent change||Inter-Quartile Range|Median
1348960|NCT01812707|Secondary|Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of lipid parameters analyzed.|||percent change||Standard Error|Least Squares Mean
1348961|NCT01812707|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.|||percentage of participants|||Number
1348962|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mg/dL||Standard Error|Least Squares Mean
1348963|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mmol/L||Standard Error|Least Squares Mean
1348964|NCT01812707|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1348965|NCT01812681|Secondary|Sepsis|Association of vitamin D level with sepsis|four weeks||||participants|||Number
1348966|NCT01812681|Primary|Respiratory Distress Syndrome|The association of vitamin D level with respiratory distress syndrome|three days||||participants|||Number
1348967|NCT01812655|Secondary|Engagement With Distraction and Belief in Distraction's Efficacy|"For Engagement with Distraction,VR and PD participants were asked on the Post-testing Questionnaire: Were you able to pay attention to the DVD or to the VR during your burn treatment? (1=could not pay attention at all; 5=totally absorbed at all times)~For Belief in Distraction's Efficacy, VR and PD participants were asked on the Post-Procedure Questionnaire: I believe that the distraction lessened my pain during my burn treatment today. (on a scale of 1=Distraction did not help to lessen my pain at all; 5=Distraction completely helped to lessen my pain at all times)"|Post-procedure (approximately 30-75 minutes)||||scores on a scale||Standard Deviation|Mean
1348968|NCT01812655|Secondary|Desire for Distraction|"Participants were asked I wanted to be distracted from during my treatment today. (Agree-Disagree) from the Post-Procedure Questionnaire"|Post-procedure (approximately 30-75 minutes)||||participants|||Number
1348969|NCT01812655|Primary|Self-reported Wound Care Procedure Pain Score|The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).|Within the first 20 minutes following completion of the burn wound care procedure|Intention to treat|||mm||95% Confidence Interval|Least Squares Mean
1348970|NCT01812473|Primary|Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.|At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.|At steady state plasma concentration of voriconazole (after day 4 of therapy)||||% of plasma protein binding|Participants|Inter-Quartile Range|Median
1348971|NCT01812057|Secondary|Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)||Intraoperatively|No data was collected intraoperatively using CNAP on any participants.||||||
1348972|NCT01812057|Secondary|Incidence of Wound Complications|Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery|24 hours from PACU admission||||Participants|||Count of Participants
1348973|NCT01812057|Secondary|Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics|"Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from >0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV.~Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic"|2, 24 and 48 hours from PACU admission||||Participants|||Count of Participants
1348974|NCT01812057|Secondary|Need for Intraoperative Analgesic Supplementation|Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain|From spinal anesthesia placement to end of surgery, approximately 70 minutes||||Participants|||Count of Participants
1348975|NCT01812057|Secondary|Incidence of Postoperative Pruritus|"Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated.~If median score >0 then patient experienced postoperative pruritus."|48 hours from admission to PACU||||Participants|||Count of Participants
1348976|NCT01812057|Secondary|Incidence of Intraoperative Pruritus|pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus|From spinal anesthesia placement to end of surgery, approximately 70 minutes|No data was collected on intraoperative pruritus on any participants.||||||
1348977|NCT01812057|Secondary|Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.|Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.|From spinal anesthesia placement to end of surgery, approximately 70 minutes||||Participants|||Count of Participants
1348978|NCT01812057|Secondary|Pain Scores Between MTS Groups|Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.|24 hours after PACU admission||||units on a scale||Inter-Quartile Range|Median
1348979|NCT01812057|Secondary|Incidence of Chronic Persistent Pain at 6 Months|Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery|6 months from the day of surgery|Analysis was based on available data from both arms including 25 patients. Data was missing for 11 patients in dexamethasone group and 11 patients in placebo group.|||Participants|||Count of Participants
1348980|NCT01812057|Secondary|Incidence of Chronic Persistent Pain at 8 Weeks|Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery|8 weeks from the day of surgery|Analysis was based on available data from both arms including 26 patients. Data was missing for 13 patients in dexamethasone group and 8 patients in placebo group.|||Participants|||Count of Participants
1348981|NCT01812057|Secondary|Cumulative Opioid Consumption at 24 Hours Between MTS Groups|Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.|24 hours from admission to Postanesthesia care unit (PACU)|Analysis was based on all 47 patients who completed the study.|||milligrams||Inter-Quartile Range|Median
1348982|NCT01812057|Secondary|Pain Scores Between the Groups at 48 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|48 hours from PACU Admission||||units on a scale||Inter-Quartile Range|Mean
1348983|NCT01812057|Secondary|Pain Scores Between the Groups at 24 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|24 hours from PACU admission||||units on a scale||Inter-Quartile Range|Median
1348984|NCT01812057|Secondary|Cumulative Opioid Consumption at 48 Hours Between the Groups|The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine|Admission to PACU through 48 hours||||milligrams||Inter-Quartile Range|Median
1348985|NCT01812057|Secondary|Time to Administration of First Rescue Analgesic Request Between the Groups.|Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain|PACU admission to discharge from PACU an average of 2 hours|Analysis was based on all 47 patients who completed the study.|||minutes||Inter-Quartile Range|Median
1348986|NCT01812057|Secondary|Pain Scores Between the Groups at 2 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|2 hours from admission to postanesthesia care unit (PACU)||||units on a scale||Inter-Quartile Range|Median
1348987|NCT01812057|Primary|Morphine Consumption at 24 Hours Post-op|The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine|24 hours from admission to Postanesthesia care unit (PACU)||||milligram||Inter-Quartile Range|Median
1348988|NCT01812044|Secondary|Peak Pain Score During First 30 Minutes|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~Pain is rated every 5 minutes for the first 30 minutes postoperatively."|0-30 minutes post-operative||||units on a scale||Standard Deviation|Mean
1348989|NCT01812044|Secondary|Number of Participants Who Required Anti-emetic Medication Post-operatively||Total time in post-operative recovery - up to 6 hours||||participants|||Number
1348990|NCT01812044|Secondary|Number of Participants With Post Operative Nausea and Vomiting||0-150 minutes post-operative||||participants|||Number
1348991|NCT01812044|Secondary|Average Time to Discharge||0-150 minutes post-operative||||minutes||Standard Deviation|Mean
1348992|NCT01812044|Secondary|Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)|"This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively.~with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior.~Lowest score 27; highest score 135"|1 week (+/- 3 days) post operatively||||units on a scale||Standard Deviation|Mean
1348993|NCT01812044|Secondary|Total Narcotic Use During Post-operative Recovery|This secondary outcome will include total narcotic use|Total time in post-operative recovery - up to 6 hours||||mcg/kg||Standard Deviation|Mean
1349053|NCT01811316|Primary|Change From Baseline in Bleeding on Probing (BOP)|Bleeding on probing was assessed 30 seconds after probing. A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively. BOP (%) is a percentage of sites BOP.|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||percentage of sites BOP||Standard Deviation|Mean
1348994|NCT01812044|Secondary|Peak Pain Score|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge."|0-150 minutes post-operative||||units on a scale||Standard Deviation|Mean
1348995|NCT01812044|Primary|Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale|"Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for “Average pain score over the first 30 post-operative minutes using the CHEOPS scale.” for each group."|0-30 minutes post-operative||||units on a scale||Standard Deviation|Mean
1348996|NCT01812005|Secondary|Complete Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 weeks (6 courses)|The data was not collected and analyzed for this outcome measure||||||
1348997|NCT01812005|Secondary|Progression-free Survival|Graphically summarized using the methods of Kaplan and Meier.|Time from study entry to the time of progression and/or death, assessed up to 1 year||||months||95% Confidence Interval|Median
1348998|NCT01812005|Secondary|Overall Survival|Graphically summarized using the methods of Kaplan and Meier.|Time from study entry to the time of death due to any cause, assessed up to 1 year|data was not collected for participants in Cohort A|||months||95% Confidence Interval|Median
1348999|NCT01812005|Secondary|Complete Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|12 weeks (4 courses)|data was not collected for participants in Cohort B (Alisertib, Rituximab)|||percentage of patients||95% Confidence Interval|Number
1349000|NCT01812005|Secondary|Complete Response Rate (CR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 weeks (2 courses)|2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug|||percentage of patients||95% Confidence Interval|Number
1349001|NCT01812005|Secondary|Overall Response Rate(ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 weeks (6 courses)||||percentage of patients|||Number
1349002|NCT01812005|Secondary|Overall Response Rate (ORR)|95% binomial confidence intervals calculated.|12 weeks (4 courses)|"Data were not collected from the single participant in the Cohort A (Alisertib, Rituximab) Arm/Group therfore the 95% Confidence Interval was incalculable due to an insufficient number of events"||||||
1349003|NCT01812005|Secondary|Overall Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 weeks (2 courses)|2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug|||percentage of patients||95% Confidence Interval|Number
1349004|NCT01812005|Primary|Best Overall Response Rate (ORR) to Alisertib Alone|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 18 weeks (6 courses)||||percentage of patients||95% Confidence Interval|Number
1349005|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1349006|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Metformin|Cmax: maximum measured concentration of the analyte in plasma for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1349066|NCT01811212|Secondary|Overall Survival|The Kaplan-Meier method will be used.|Time from start of treatment to time of death, assessed up to 1 year|the end of the range was not reached|||months||95% Confidence Interval|Median
1349007|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin|Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1349008|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1349009|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1349010|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1349011|NCT01811732|Secondary|Investigator Assessment at the Late Follow-up Visit|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 21 to 28|ITT Population|||Participants|||Count of Participants
1349012|NCT01811732|Secondary|Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 14 +/- 1 day|ITT Population|||Participants|||Count of Participants
1349013|NCT01811732|Primary|Objective Response at 48 to 72 Hours (FDA Primary Endpoint)|A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.|48 to 72 hours after starting treatment|ITT Population|||Participants|||Count of Participants
1349014|NCT01811706|Secondary|Biomechanical Assessment of Gait (BAG)-Stride Length|Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. Stride length was analyzed. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo||||cm||Standard Deviation|Mean
1349015|NCT01811706|Secondary|Change in Scale of Assessment and Rating of Ataxia (SARA)|Scale for the assessment and rating of ataxia (SARA) is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level. SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. SARA score ranges from 0 to 40, with higher scores indicating more severe disease.|Baseline and 4 weeks after Dalfampridine or placebo||||point||Standard Deviation|Mean
1349016|NCT01811706|Primary|Change in Timed 25 Feet Walking Test (T25FW)|The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo|Patient with spinocerebellar ataxia (SCA) 1, 2, 3, or 6|||second||Standard Deviation|Mean
1349019|NCT01811563|Other Pre-specified|Timed Get up and go|The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||Seconds||Standard Deviation|Mean
1349020|NCT01811563|Other Pre-specified|Sit to Stand Time|The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||Number of times||Standard Deviation|Mean
1349021|NCT01811563|Other Pre-specified|Knee Society Score (KSS)|The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|Only 20 subjects in each arm completed the assessment at 1 year post-op.|||units on a scale||Standard Deviation|Mean
1349022|NCT01811563|Other Pre-specified|Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.|"The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely forgotten) and 0 indicating the worst outcome."|6 weeks and 52 weeks following total knee replacement|Participants who completed the Forgotten Joint Score (FJS) at week 6 and week 52. Not all subjects completed the FJS.|||units on a scale||Standard Deviation|Mean
1349023|NCT01811563|Other Pre-specified|Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.|The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|Baseline (Pre-Operative) and 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||units on a scale||Standard Deviation|Mean
1349024|NCT01811563|Other Pre-specified|University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.|"The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is Wholly Inactive, dependent on others, and can not leave residence and 10 is Regularly participates in impact sports."|6 weeks following total knee replacement|Only subjects who were able to complete the UCLA at six weeks were included in the analysis.|||units on a scale||Standard Deviation|Mean
1349025|NCT01811563|Other Pre-specified|Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.|"The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is Wholly Inactive, dependent on others, and can not leave residence and 10 is Regularly participates in impact sports."|Baseline and 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||units on a scale||Standard Deviation|Mean
1349026|NCT01811563|Secondary|Walking Speed at 6 Weeks Following Total Knee Replacement.|Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.|6 weeks following total knee replacement||||miles per hour||Standard Deviation|Mean
1349027|NCT01811563|Secondary|Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.|Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.|Baseline and 52 weeks following total knee replacement||||miles per hour||Standard Deviation|Mean
1349028|NCT01811563|Primary|Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement|The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.|Baseline (Pre-Operative) to 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||% of limb length||Standard Deviation|Mean
1349082|NCT01810952|Secondary|Percent of Participants With Average Glucose >70 and <180 mg/dL|Percent of Participants with Average Daily Glucose >70 and <180 mg/dL|Last Full Day of Protocol for Participant (up to Day 5)||||percentage of participants|||Number
1349299|NCT01808261|Secondary|Number of Participants Experiencing Falls|The number of participants who experienced at least one fall between BL to Day 90 and BL to Day 180 is summarized.|BL (Day 1) Day 90 and Day 180|Safety population is defined as participants who had received at least one infusion of investigational product.|||Participants|||Count of Participants
1349029|NCT01811563|Primary|Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement|The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.|Baseline (Pre-Operative) to 6 weeks following total knee replacement|Only subjects that were able to complete all of the YBT assessments at 6 weeks post total knee replacement were included in the analyses.|||% of limb length||Standard Deviation|Mean
1349030|NCT01811485|Secondary|Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death|The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|14 weeks|Safety set (SAF): consists of all patients who received at least one dose of study medication.|||Patients|||Number
1349031|NCT01811485|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline to 14 weeks|FAS consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||mg/dL||Standard Error|Least Squares Mean
1349032|NCT01811485|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|"Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c < 7% 3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c < 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%.~Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements."|Baseline, 14 weeks|The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||Percentage of patients|||Number
1349033|NCT01811485|Secondary|Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups|HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1349034|NCT01811485|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1349035|NCT01811472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability||24 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least 1 post-baseline safety assessment.|||Patients|||Number
1349036|NCT01811472|Secondary|Change From Baseline in Waist Circumference||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis|||centimeter (cm)||90% Confidence Interval|Least Squares Mean
1349037|NCT01811472|Secondary|Change From Baseline in Body Weight||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis|||kilogram (kg)||90% Confidence Interval|Least Squares Mean
1349038|NCT01811472|Secondary|Post-prandial Peak Triglycerides Over 0 - 8 Hours|"Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours.~Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis|||mg/dL||90% Confidence Interval|Geometric Mean
1349039|NCT01811472|Secondary|Percent Change From Baseline in Fasting Triglycerides|"Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast.~Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis|||percent change||90% Confidence Interval|Geometric Mean
1349040|NCT01811472|Secondary|Percentage of Patients With Normalized Liver Enzymes|Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose.|Baseline, week 6, week 12 and week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoints were included in this endpoint analysis.|||Percentage of patients|||Number
1349041|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 24 were included in this endpoint analysis.|||U/L||90% Confidence Interval|Least Squares Mean
1349042|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 12 were included in this endpoint analysis.|||U/L||90% Confidence Interval|Least Squares Mean
1349043|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 6|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoint were included in this endpoint analysis.|||U/L||90% Confidence Interval|Least Squares Mean
1349044|NCT01811472|Secondary|Percentage of Responders at Week 24|"The response criteria are defined as:~a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 24 were included in this endpoint analysis.|||Percentage of responders|||Number
1349045|NCT01811472|Secondary|Percentage of Responders at Week 12|"The response criteria are defined as:~a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|At week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 12 were included in this endpoint analysis.|||Percentage of responders|||Number
1349046|NCT01811472|Secondary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 12 are included in this analysis.|||Percentage of liver fat||90% Confidence Interval|Least Squares Mean
1349047|NCT01811472|Primary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 24 are included in this analysis.|||Percentage of liver fat||95% Confidence Interval|Least Squares Mean
1349048|NCT01811355|Primary|Cramp Severity|Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity|6 weeks|Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.|||units on a scale||Standard Deviation|Mean
1349049|NCT01811355|Primary|Daily Muscle Cramps|The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.|6 weeks|Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.|||Cramps per 24 hours||Standard Deviation|Mean
1349050|NCT01811316|Other Pre-specified|Change From Baseline in Inflammatory Markers in Gingival Crevicular|Gingival Crevicular Fluid (GCF) samples will be analyzed for inflammatory cytokines/chemokines and matrix metalloproteases using multiplexing ELISA.|15 days, 4, 12 and 24 weeks|||||||
1349051|NCT01811316|Secondary|Change From Baseline in Probing Depth (PD)|Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||mm||Standard Deviation|Mean
1349052|NCT01811316|Secondary|Change From Baseline in Plaque Index (PI)|"Plaque Index of Turesky Modification of Quigley-Hein (Turesky, Gilmore et al. 1970) (PI) was scored on all natural teeth (except third molars) after disclosing with erythrosine solution. Scores Criteria:~0 No plaque~Separate flecks of plaque at the cervical margin of the tooth~A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth~A band of plaque wider than one mm but covering less than one-third of the crown of the tooth~Plaque covering at least one-third but less than two-thirds of the crown of the tooth~Plaque covering two-thirds or more of the crown of the tooth"|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||units on a scale||Standard Deviation|Mean
1349054|NCT01811316|Primary|Change From Baseline in Modified Gingival Index (MGI)|"Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation)~Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit~Mild inflammation of the entire gingival unit~Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit~Severe inflammation (marked redness and edema/hyper-trophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.~Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites."|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||units on a scale||Standard Deviation|Mean
1349055|NCT01811303|Secondary|Maximum Blood Glucose Concentration (C Max) Over the Baseline|"Determine the glucose C max of Sucrose with D-fagomine over the baseline.~The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline.~Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)"|Usually in the range of 30-45 minutes||||mmol/L||Standard Error|Mean
1349056|NCT01811303|Primary|Postprandial Glycaemic Response Index|On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.|120 minutes|The number of participants >10, the repetitions >= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145–171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09.|||percentage of AUC fagomine/AUC control||95% Confidence Interval|Mean
1349057|NCT01811238|Secondary|Patient Global Impression of Change(PGIC)|Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Baseline, 8week|IIT set, Missing values were imputed by LOCF.|||participants|||Number
1349058|NCT01811238|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ (score = 100) and ‘Worst imaginable health state’ (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline, 8 weeks|ITT set, Missing values were imputed by LOCF. Difference (Visti 4(8w)-Baseline)|||scores on a scale||Standard Deviation|Mean
1349059|NCT01811238|Secondary|Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 4/ET minus mean score at Baseline."|Baseline, 4 week|IIT set.|||units on a scale||Standard Deviation|Mean
1349060|NCT01811238|Secondary|Clinical Global Impression of Change(CGIC)|"The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF.~Very much improved much improved minimally improved no change minimally worse much worse very much worse"|Baseline, 8 week|ITT Population. Below results : Visit 4(8week)(LOCF): n(%)|||participants|||Number
1349061|NCT01811238|Secondary|The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by “1” means that the healthy condition and high quality of life."|Baseline, 8 week|ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.Missing values were imputed by LOCF.|||scores on a scale||Standard Deviation|Mean
1349062|NCT01811238|Primary|Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 8/ET minus mean score at Baseline."|Baseline, 8 week|"The 209 is IIT set population. ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.~Missing values were imputed by LOCF."|||scores on a scale||Standard Deviation|Mean
1349063|NCT01811212|Secondary|Response of Cabozantinib-s-malate in Bone Metastasis (Bone Metastasis-specific Progression Free Survival) as Evaluated by Functional Imaging||Up to 2 months|Data not collected to be analyzed at this time||||||
1349064|NCT01811212|Secondary|Progression-free Survival|The Kaplan-Meier method will be used.|Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year||||months||95% Confidence Interval|Median
1349065|NCT01811212|Secondary|Percent Change in Serum Tumor Marker Thyroglobulin Levels|Side-by-side boxplots will be used to assess possible differences in this change between responders and non-responders, and scatterplots can assess the influence of baseline thyroglobulin levels on these measures of change.|Baseline to 6 months|Data not collected to be analyzed at this time||||||
1349067|NCT01811212|Secondary|Incidence of Severe (Grade 3+) Adverse Events, Graded According to the National Cancer Institute CTCAE v4.0|The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Tolerability of the regimens will be assessed through assessing the number of patients who required dose modifications and/or dose delays. In addition, the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial will be captured.|Up to 1 year||||Participants|||Count of Participants
1349068|NCT01811212|Secondary|Genotype of Biomarkers Potentially Predictive of Response|These baseline levels will be quantitatively summarized and graphically explored, in particular in terms of how they relate to clinical outcomes of interest. Analyses exploring differences in these angiogenic and correlative markers in relation to clinical outcomes will be largely hypothesis-generating. With limited numbers of patients patterns of difference will primarily be looked for using graphical analyses; these can include plots of these marker levels in relation to clinical outcomes to identify potential patterns of interest.|Baseline|Data not collected to be analyzed at this time||||||
1349069|NCT01811212|Secondary|Expression Levels of Predictive Biomarkers of Response by Immunohistochemistry in Archived Tumor Tissue|These baseline levels will be quantitatively summarized and graphically explored, in particular in terms of how they relate to clinical outcomes of interest. Analyses exploring differences in these angiogenic and correlative markers in relation to clinical outcomes will be largely hypothesis-generating. With limited numbers of patients patterns of difference will primarily be looked for using graphical analyses; these can include plots of these marker levels in relation to clinical outcomes to identify potential patterns of interest.|Baseline|Data has not been collected and analyzed at this time||||||
1349070|NCT01811212|Secondary|Duration of Objective Response as Assessed by the RECIST v1.1|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From date of documentation of response to the date of progression or death, assessed up to 1 year||||months||95% Confidence Interval|Median
1349071|NCT01811212|Secondary|Bone Turnover, as Measured by Serum and Urinary Markers of Bone Turnover||Up to 2 months|Data not collected to be analyzed at this time||||||
1349072|NCT01811212|Primary|Objective Response Rate, Defined as the Proportion of Patients Who Have Had a PR or CR as Assessed by the RECIST Version (v)1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 months||||Participants|||Count of Participants
1349073|NCT01811186|Secondary|Assessment of Subject’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug|At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC).|6weeks|ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.|||participants|||Number
1349074|NCT01811186|Secondary|Assessment of Investigator’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug|Investigator’s overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher’s exact test.|6 weeks|ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.|||participants|||Number
1349075|NCT01811186|Secondary|Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life."|6 weeks|ITT analysis set.|||units on a scale||Standard Deviation|Mean
1349076|NCT01811186|Secondary|The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.|Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable).|6 weeks|ITT analysis set: 258|||units on a scale||Standard Deviation|Mean
1349077|NCT01811186|Secondary|The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.|The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher’s exact test.|1 week|Intent to treat analysis set: 258(Last observation Carried Forward)|||percentage of participants|||Number
1349078|NCT01811186|Primary|Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment|To assess the drop-out rate caused by adverse event* after 6 weeks treatment|6 weeks|Intent to treat analysis set: 258 patients (Last Observation Carried Forward)|||percentage of participants|||Number
1349079|NCT01810952|Post-Hoc|Percent of Glucose Determinations >180 mg/dL||1-5 days||||Percent of glucose values|||Number
1349080|NCT01810952|Secondary|Glucose Values <70 mg/dL.|# participants with glucose values <70 mg/dL|1-5 days||||participants|||Number
1349081|NCT01810952|Secondary|Daily Insulin Dose/Kg Body Weight|Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL|1-5 days||||units of insulin/Kg body weight||Standard Deviation|Mean
1352745|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1349083|NCT01810952|Primary|Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.|"Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."|1-5 days|We used t-tests to compare values between the protocols on each day..|||mg/dL||Standard Deviation|Mean
1349084|NCT01810939|Primary|Change in Serum Potassium From Part B Baseline|"Change in Serum Potassium from Part B Baseline to either:~Part B Week 4 visit, if the participant’s serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant’s serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L."|Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L||||mEq/L||Inter-Quartile Range|Median
1349085|NCT01810939|Primary|Change in Serum Potassium From Part A Baseline to Part A Week 4|The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).|Part A Baseline to Part A Week 4||||mEq/L||Standard Error|Least Squares Mean
1349086|NCT01810939|Secondary|Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B||Part B Baseline to Part B Week 8|Percentages were estimated not as simple ratios, but by using a stratified method, in order to account for differences between the patiromer and placebo groups in terms of whether participants had type 2 diabetes mellitus and whether they entered the study with serum potassium < 5.8 mEq/L or serum potassium ≥ 5.8 mEq/L.|||percentage of participants|||Number
1349087|NCT01810939|Secondary|Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B||Part B Baseline to Part B Week 8||||percentage of participants|||Number
1349088|NCT01810939|Secondary|Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4||Week 4|Proportion of participants with serum potassium level in the target range at Part A Week 4|||percentage of participants||95% Confidence Interval|Number
1349089|NCT01810783|Primary|Safety and Tolerability|Number of treatment-emergent adverse events (TEAEs)|Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)|210 patients were enrolled, only 209 patients were treated with brexpiprazole.TAES is based on these 209 patients|||TEAEs|||Number
1349090|NCT01810692|Secondary|Overall Satisfaction Question|The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.|day 1|Patients from FAS|||units on a scale||Standard Deviation|Mean
1349091|NCT01810692|Secondary|Total Convenience PASAPQ Score|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.|||units on a scale||Standard Deviation|Mean
1349092|NCT01810692|Secondary|Total Performance PASAPQ Score.|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.|||units on a scale||Standard Deviation|Mean
1349093|NCT01810692|Primary|Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)|Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.|||units on a scale||Standard Deviation|Mean
1349094|NCT01810666|Secondary|Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period|Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set.|From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)||||Scores on scale||95% Confidence Interval|Median
1349095|NCT01810666|Secondary|Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period|Annualized joint bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)||||Bleeds||95% Confidence Interval|Median
1349096|NCT01810666|Primary|Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period|Annualized bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)||||Bleeds||95% Confidence Interval|Median
1349097|NCT01810380|Secondary|PSP Domain D: Disturbing and Aggressive Behaviours at Week 6|PSP domain D: disturbing and aggressive behaviours were categorised as “aggressive” (corresponding to mild, manifest, marked, severe, or very severe) or “nonaggressive” (corresponding to absent)|Week 6|FAS. As this was based on observed cases, only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used.|||percentage of aggressive patients|||Number
1349098|NCT01810380|Secondary|PSP Functional Response Rate at Week 6|The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.|||percentage of responders|||Number
1349159|NCT01809262|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|2 weeks|Safety set|||percentage of participants|||Number
1349099|NCT01810380|Secondary|PSP Functional Remission Rate at Week 6|The PSP functional remission rate was defined as a PSP total score ≥71|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.|||percentage of remitters|||Number
1349100|NCT01810380|Secondary|Change From Baseline to Week 6 in PSP Total Score|The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient’s current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance.|Baseline and Week 6|FAS. PSP was collected at Baseline, Day 21 and Day 42 only, due to the windowing only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF.|||units on a scale||Standard Error|Mean
1349101|NCT01810380|Secondary|Response Rate at Week 6|The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2|Baseline and Week 6|FAS (last assessment)|||percentage of responders|||Number
1349102|NCT01810380|Secondary|Discontinuation Due to Lack of Efficacy During the Study|Discontinuation due to lack of efficacy was based on the primary reason for withdrawal|Baseline to Week 6|APTS|||percentage of patients|||Number
1349103|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349104|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349105|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349106|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349107|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349108|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Excited Component Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349109|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349310|NCT01808209|Secondary|Conjunctival Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale|Participants|Standard Deviation|Mean
1349110|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349111|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349112|NCT01810380|Secondary|CGI-I Score at Week 6|"The Clinical Global Impression – Global Improvement (CGI-I) provides the clinician’s impression of the patient’s improvement (or worsening).~The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not."|Week 6|FAS|||units on a scale||Standard Error|Mean
1349113|NCT01810380|Secondary|Change From Baseline to Week 6 in CGI-S Score|"The Clinical Global Impression – Severity of Illness (CGI-S) provides the clinician’s impression of the patient’s current state of mental illness.~The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients)."|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
1349114|NCT01810380|Primary|Change From Baseline to Week 6 in PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1349115|NCT01810302|Secondary|Number of Participants With Cerebral Vasospasm.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.||||||
1349116|NCT01810302|Primary|Number of Participants With Bacterial Meningitis.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.||||||
1349117|NCT01810289|Secondary|Evaluate the Effect of START on the Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period.||3 years|||||||
1349118|NCT01810289|Secondary|Evaluate the Effect of START on HIV RNA Levels Among Treatment-eligible, HIV-infected Patients||3 years|||||||
1349119|NCT01810289|Secondary|Evaluate the Effect of START on Retention in HIV Care Among Treatment-eligible, HIV-infected Patients.||3 years|||||||
1349120|NCT01810289|Secondary|Evaluate the Effect of START on the Incidence of Mortality in Treatment-eligible, HIV-infected Patients.||3 years|||||||
1349121|NCT01810289|Primary|Evaluate Programmatic Change of START on Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients||3 years||||participants|||Number
1349122|NCT01810263|Other Pre-specified|Subjective Global Assessment||6 months|||||||
1349123|NCT01810263|Other Pre-specified|Triceps Skin Fold Thickness||6 months|||||||
1349124|NCT01810263|Other Pre-specified|Body Mass Index||6 months|||||||
1349125|NCT01810263|Secondary|Chemical Laboratory Findings||6 months|||||||
1349126|NCT01810263|Primary|Modified Barthel Index (MBI) Score at 6 Months|Scale range: 0-100 (higher values represent a better outcome)|6 months||||units on a scale||Standard Deviation|Mean
1349127|NCT01810042|Secondary|Visual Acuity Changes|"Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline.~Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline."|baseline and 6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.|||ETDRS letters||Full Range|Median
1349128|NCT01810042|Secondary|Visual Acuity in ETDRS Letters|Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.|||ETDRS letters||Full Range|Median
1349129|NCT01810042|Secondary|Lesion Size of CNV|Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.|||square milimeter||Full Range|Mean
1349130|NCT01810042|Primary|Caliber of Choroidal New Vessel (CNV)|Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.|6 months|Of 31 patients included in the baseline analysis, 7 patients had the thickest vessels under limitation of measurement.|||micrometer||Full Range|Mean
1349146|NCT01809834|Primary|Participant's Subjective Rating of Comfort (Questionnaire)|Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week|Insertion, After Lens settling, 12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)|||units on a scale|Participants|Standard Deviation|Mean
1349131|NCT01809938|Secondary|T½|"T½ = time from baseline to the time the cross-sectional surface area (CSA) of the gastric antrum, measured using realtime ultrasound, returned to half the maximal value (CSA½max ). CSA ½ max calculated as below:~CSA½max = CSAmax - [(CSAmax - CSAbaseline)/2]"|Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours.|It was difficult to visualise under ultrasound the gastric antrum in one patient after they drank both black tea and tea with milk, so they were exlcuded from final analysis of the US data only.|||minutes||95% Confidence Interval|Geometric Mean
1349132|NCT01809938|Primary|Tmax|tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements.|Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours||||minutes||Standard Deviation|Mean
1349133|NCT01809899|Secondary|Heart Rate|Heart rate was measured while in the scanner as a secondary psychobiological outcome to be considered in tandem with the BOLD signals from the scanner.|Baseline|No analyses were conducted due to an error in the scanner that resulted in no usable neuroimaging or physiological data. This includes the BOLD signal as well as the heart rate data and all other data collected while in the scanner.||||||
1349134|NCT01809899|Primary|Blood Oxygen-Level Dependent (BOLD) Signal|Functional Magnetic Resonance Imaging (fMRI). We were examining differences in Blood Oxygen-Level Dependent (BOLD) signal indicating reaction to a stress-provocation paradigm between the Enhanced Consent and Consent as Usual conditions.|Baseline|No analyses were conducted due to an error in the scanner that resulted in no usable neuroimaging or physiological data. This includes the BOLD signal as well as the heart rate data and all other data collected while in the scanner.||||||
1349135|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
1349136|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
1349137|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination).~(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion, 12-hours, 1-week||||logMAR|Participants|Standard Deviation|Log Mean
1349138|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination).~(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion||||logMAR|Participants|Standard Deviation|Log Mean
1349139|NCT01809834|Primary|Participant's Subjective Rating of Overall Preference (Questionnaire)|Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week|12-hours, 1-week||||score on a scale||Standard Deviation|Mean
1349140|NCT01809834|Primary|Participant's Subjective Rating of Visual Quality (Questionnaire)|Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week|12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
1349141|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)|Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week|12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)|||units on a scale|Participants|Standard Deviation|Mean
1349142|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)|Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing|Dispense||||score on a scale|Participants|Standard Deviation|Mean
1349143|NCT01809834|Primary|Participant's Subjective Rating of Dryness (Questionnaire)|Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week|12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
1349144|NCT01809834|Secondary|Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)|"Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good).~Change over time measured at insertion, 12-hours, 1-week"|Insertion, 12 hours, 1 week||||units on a scale|Participants|Standard Deviation|Mean
1349145|NCT01809834|Secondary|Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)|"Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced).~Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week)."|Insertion, 12 hours, 1 week||||units on a scale|Participants|Standard Deviation|Mean
1349311|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week||||units on a scale|Participants|Standard Deviation|Mean
1349147|NCT01809639|Primary|Time (in Days) That a Patient Reports Symptoms From Their Concussion.|The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline.|From date of injury until date asymptomatic, assessed up to 24 months||||Days Symptomatic||Standard Error|Mean
1349148|NCT01809327|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Up to 30 weeks of last study drug administration|Safety Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug.|||participants|||Number
1349149|NCT01809327|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1349150|NCT01809327|Secondary|Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percent change||Standard Error|Least Squares Mean
1349151|NCT01809327|Secondary|Change in Systolic Blood Pressure From Baseline at Week 26|The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||millimeter of mercury (mm Hg)||Standard Error|Least Squares Mean
1349152|NCT01809327|Secondary|Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26|The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.|Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1349153|NCT01809327|Secondary|Percent Change in Body Weight From Baseline to Week 26|The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percent change||Standard Error|Least Squares Mean
1349154|NCT01809327|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26|The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percentage of hemoglobin||Standard Error|Least Squares Mean
1349155|NCT01809314|Secondary|Percentage of Participants Who Required Blood Transfusions During the Study|The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.|Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4|"All Participants Enrolled. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants who provided data for the analysis at each timepoint (n) is shown in the table."|||percentage of participants|||Number
1349156|NCT01809314|Secondary|Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT|"ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as Baseline 0, EOT 2. Transition to a lower performance status indicates improved/increased independence."|Baseline, Month 4|"All Participants Enrolled; only those who provided data at all study visits were included in the analysis. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants used in the denominator for each calculation (n) was based on the ECOG status at Baseline."|||percentage of participants|||Number
1349157|NCT01809314|Primary|Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)|The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).|Baseline, Month 4|All Participants Enrolled; only those who provided data at all study visits were included in the analysis.|||g/L||95% Confidence Interval|Mean
1349160|NCT01809262|Secondary|Number of Patients Requiring Rescue Medication on a Test-day|Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.|Visits 1,2,4,5,6|Safety set which consisted of all randomised patients who had taken at least one dose of study medication.|||Number of Patients|||Number
1349161|NCT01809262|Secondary|Time to Onset of Response|Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.|||minutes||Standard Deviation|Mean
1349162|NCT01809262|Secondary|Time to Peak Bronchodilator Response|A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.|||minutes||Standard Deviation|Mean
1349163|NCT01809262|Secondary|Peak Forced Vital Capacity (FVC) From 0 to 3 Hours|Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
1349164|NCT01809262|Secondary|Peak FEV1 From 0 to 3 Hours|Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
1349165|NCT01809262|Secondary|FEV1 AUC 12 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
1349166|NCT01809262|Secondary|FEV1 AUC 0 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
1349167|NCT01809262|Secondary|FEV1 AUC 0 - 12 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
1349168|NCT01809262|Secondary|FEV1 AUC 0 - 3 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
1349169|NCT01809262|Primary|Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment|Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.|24 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data for FEV1 at 24 hours.|||L||Standard Error|Mean
1349170|NCT01809210|Secondary|CL/F|Apparent oral plasma clearance|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||L/h||Standard Deviation|Mean
1349171|NCT01809210|Secondary|Tmax,ss|Time to reach maximum plasma concentration at steady state|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||h||Full Range|Median
1349172|NCT01809210|Secondary|Cmax,ss|Maximum plasma concentration at steady state|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1349173|NCT01809210|Secondary|AUC (0-tau)|Area under the concentration time curve (AUC) over a dosing interval at steady state (0-tau)|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1349312|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|Baseline|Prior to randomization|||units on a scale|Participants|Standard Deviation|Mean
1349174|NCT01809210|Secondary|Objective Response Rate (ORR)|The number of patients who had at least 1 confirmed visit response of Complete Response (CR) or Partial Response (PR) prior to any evidence of progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR|Up until progression or last evaluable assessment in the absence of progression, up to 9 months|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||participants|||Number
1349175|NCT01809210|Secondary|Best Percentage Change From Baseline in Target Lesion Size|The best percentage change in tumour size a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Percentage change was derived at each visit by the percentage change in the sum of the diameters of target lesions|Screening, week 6 and week 12|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||% change||Standard Deviation|Mean
1349176|NCT01809210|Secondary|Percentage Change From Baseline at 6 Weeks in Target Lesion Size|The percentage change in the sum of the diameters of target lesions|Week 6|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||% change||Standard Deviation|Mean
1349177|NCT01809210|Secondary|Best Objective Response|The best response a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions, the sum must also demonstrate an absolute increase of >=5mm; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm|Screening, week 6 and week 12|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||participants|||Number
1349178|NCT01809210|Primary|Dose Limiting Toxicity (DLT) Events in Chemotherapy in Combination With Selumetinib|Any toxicity not attributable to the disease or disease-related processess under investigation, considered related to the combination of chemotherapy plus selumetinib, which occurs within the timeframe and is dose limiting|The first dose on Cycle 1 Day 1 up to the time before dosing on Cycle 2 Day 1, assessed up to 3 weeks|Safety analysis set - all patients who received at least 1 dose of selumetinib.|||participants|||Number
1349179|NCT01809197|Primary|"Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses"|Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.|Day 30; after 4 hours of lens wear|This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.|||units on a scale||Standard Deviation|Least Squares Mean
1349180|NCT01809106|Other Pre-specified|The Opioid Escalation Index|The proportion of subjects with an increase of opioid daily dose > 5% compared with the basal dosage (OEI%).|28 days||||participants|||Number
1349181|NCT01809106|Secondary|Proportion of Full-responder|Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/> 30% from visit 6 and visit 1 (NRS 0 to 10).|28 days||||participants|||Number
1349182|NCT01809106|Primary|Proportion of Non-Responder (NR) Participants|Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity “stable” or “worsened” at day 28 compared with baseline values.|28 days|Intention-to-treat|||participants|||Number
1349183|NCT01809054|Secondary|Deep Vein Thrombosis|verified by ultrasound|6 weeks||||participants|||Number
1349184|NCT01809054|Primary|Blood Loss|requiring transfusion|6 weeks||||participants|||Number
1349185|NCT01808963|Primary|Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine|Respired gas heat content|1 year.||||Joules per minute||Standard Deviation|Mean
1349186|NCT01808950|Secondary|Global Judgment of Tolerability by Investigator by Means of a 6-point Scale||8 weeks after a maximal treatment period of 4 weeks|||||||
1349187|NCT01808950|Secondary|Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs||up to 12 weeks|||||||
1349188|NCT01808950|Secondary|Evaluation of Local Tolerability by Means of 5-point Scales|local skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation judged by investigator by means of 5-point scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).|up to 12 weeks|||||||
1349189|NCT01808950|Secondary|Complete Clinical Clearance Rate||8 weeks after the 4 weeks treatment period|data were not collected for any of study participant.||||||
1349190|NCT01808950|Primary|Histological Cure Rate||8 weeks after a maximal treatment period of 4 weeks|data were not collected for any of study participant.||||||
1349191|NCT01808755|Primary|Days|time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture|168||||days||Standard Deviation|Mean
1349192|NCT01808651|Secondary|Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline up to 52 weeks|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1349193|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score. LSM (least square mean) and SE (standard error) are from visit 16.|||units on a scale||Standard Error|Least Squares Mean
1349194|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
1349195|NCT01808651|Secondary|Percentage of Participants Achieving a Remission at Week 52|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to Week 52|Participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
1349196|NCT01808651|Secondary|Percentage of Participants Achieving a Response at Week 52|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|Baseline, up to Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||Percentage of participants|||Number
1349197|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during Study Period 1.|||units on a scale||Standard Error|Least Squares Mean
1349198|NCT01808651|Primary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 52|Participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during Study Period 1.|||participants|||Number
1349199|NCT01808651|Primary|Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)||Baseline through Week 52.|Participants who received at least 1 dose of the study drug were evaluated for AEs and SAEs. SAE reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 1.|||participants|||Number
1349200|NCT01808612|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through 6 weeks|Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period.|||participants|||Number
1349201|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline, up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data.|||units on a scale||Standard Error|Least Squares Mean
1349202|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
1349203|NCT01808612|Secondary|Percentage of Participants Achieving a Remission at 6-Week Endpoint|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
1349204|NCT01808612|Secondary|Percentage of Participants Achieving a Response at 6-Week Endpoint|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
1349205|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
1349206|NCT01808612|Primary|Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
1349207|NCT01808560|Other Pre-specified|Mean Change in Tear Break-up Time (TBUT)|"The Investigator or designee measures tear break-up time (TBUT) under a slit-lamp biomicroscope following instillation of fluorescein dye in the eye using the Dry Eye Test (DET) method.~Tear film break-up is defined as the first observed break-up of the tear film following the third blink. Using a stopwatch to record the time, start the stopwatch as soon as the subject opens his/her eyes after the third blink and stop the stopwatch when the first break-up of the tear film is observed.~Any values recorded as greater than 20 seconds were converted to 20 seconds in the analysis. Three separate measurements were taken for each eye and were averaged for analysis. A higher tear break-up time indicates better tear film stability."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in TBUT (in seconds)|Eyes|Standard Deviation|Mean
1349208|NCT01808560|Other Pre-specified|Mean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion)|"Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid at the visits. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator, to apply gentle pressure along the eyelid margin. This instrument provided a standardized method of applying the same amount of pressure at each visit and for each eye to ensure measurement consistency.~The number of meibomian glands yielding liquid secretion (MGYLS) (i.e., cloudy or clear liquid with a grade of 2 or 3) was counted out of the 15 glands assessed with a range of 0 to 15. A higher total meibomian gland score or higher number of MGYLS reflects less meibomian gland dysfunction."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in Number of MGYLS|Eyes|Standard Deviation|Mean
1349209|NCT01808560|Other Pre-specified|Mean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months|"The National Eye Institute Visual Function Questionnaire (NEI-VFQ) evaluates frequency or severity of a symptoms and the effect on activities of daily living.~The questionnaire has an overall score and 12 subscale scores for general health, general vision, ocular pain, difficulty with near vision activities, difficulty with distance vision activities, social functioning limitations due to vision, mental functioning limitations due to vision, role limitations due to vision, dependency on others due to vision, driving difficulties, color vision and peripheral vision.~The NEI-VFQ scores range from 0 to 100 with lower scores indicating more symptoms or difficulty with activities of daily living. The questionnaire is scored by recoding responses to set values on a 0 to 100 scale such that the lowest value is set to 0 and the highest value is set to 100. The overall score is the average of vision subscale scores, excluding general health question."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in NEI-VFQ-25 Composite Score||Standard Deviation|Mean
1349210|NCT01808560|Other Pre-specified|Mean Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months|Dry eye symptoms assessed using the OSDI questionnaire are sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The assessment considers the frequency that problems with the eyes limit performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes feel uncomfortable is assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale is: 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time) and 4 (all of the time). The subject can answer not applicable (N/A) if the subject did not experience the situation or condition in the past week. Total OSDI score is calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower OSDI score represents less disability from dry eye symptoms.|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in Total OSDI Score||Standard Deviation|Mean
1349211|NCT01808560|Secondary|Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months|Assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. It was defined as the mean change in SPEED score in the LF Treatment group compared to Control group from Baseline to 3 Months. The symptoms assessed are dryness, grittiness / scratchiness; soreness / irritation; burning / watering; and eye fatigue. Symptom frequency is on a scale of: 0 (never), 1(sometimes), 2 (often) and 3 (constant). Symptom severity is on a scale of: 0 (no problems), 1 (tolerable–not perfect but not uncomfortable), 2 (uncomfortable-irritating but does not interfere with my day), 3 (bothersome-irritating and interferes with my day) and 4 (intolerable-unable to perform my daily tasks). SPEED score is calculated as sum of frequency and severity scores for symptoms over a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in SPEED Score||Standard Deviation|Mean
1349212|NCT01808560|Primary|Mean Change in Total Meibomian Gland Score|"The primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery.~Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 glands were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range of 0 to 45."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in Meibomian Gland Score|Eyes|Standard Deviation|Mean
1349213|NCT01808547|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.|||participants|||Number
1349214|NCT01808534|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.|Up to 2 years|All patients who enrolled and received treatment.|||participants|||Number
1349215|NCT01808534|Secondary|Overall Survival|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.|Up to 2 years|All patients who enrolled and received treatment.|||months||90% Confidence Interval|Median
1349216|NCT01808534|Secondary|Progression Free Survival (PFS)|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Up to 2 years|All patients who enrolled and received treatment.|||months||90% Confidence Interval|Median
1349217|NCT01808534|Secondary|Duration of Remission in Patients Who Achieve a Partial or Complete Response|The duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.|Up to 2 years||||months||90% Confidence Interval|Median
1349218|NCT01808534|Primary|Overall Response Rate (Defined as Partial Response or Complete Response)|The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.|Up to 2 years|All patients who enrolled and received treatment with at least one post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1349219|NCT01808508|Secondary|Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months|As secondary outcome of the second aim, we will use the distance walked during the 6 minute walk test.|4 Months|The majority of subjects were unable to follow instructions properly and therefore none could successfully complete the test. Thus the results were not considered to be valid.||||||
1349220|NCT01808508|Secondary|Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months|The change in left ventricular mass index score, measured on echocardiography, was used to assess the relationship between obstructive sleep apnea syndrome and cardiovascular function of individuals with Down syndrome. Left ventricular (LV) mass was calculated from M-mode measurements of the LV end-diastolic dimension, the thickness of the interventricular septum and the thickness of the LV posterior wall, and presented as a z-score.|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up|||z-score||Inter-Quartile Range|Median
1349221|NCT01808508|Secondary|Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months|The change in behavioral domain was measured by the Child Check Behavior List. The CBCL is a widely used method of identifying problem behavior in children. Problems are identified by a respondent who knows the child well, usually a parent or other care giver. There are 2 versions based on the child's age (CBCL/1½-5 for use children 18 months-5 years; the CBCL/6-18 for children aged 6-18 years). The checklists consists of a number of statements about the child's behavior and responses are recorded on a scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The preschool checklist contains 100 questions and, school-age checklist contains 120 questions. 8 sub-scores (1 for each of 8 syndromes: anxious/depressed, withdrawn depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior and aggressive behavior) are calculated, each ranging from 0 (normal) to 16 (clinical behavior).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up|||units on a scale||Inter-Quartile Range|Median
1349222|NCT01808508|Primary|Change in Epworth Sleepiness Scale From Baseline to End of Study|The primary aim of the study is to assess the relationship between obstructive sleep apnea syndrome (OSAS) and the neurocognitive and behavioral outcomes of individuals with Down syndrome. Sleepiness was assessed using the pediatric version of the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person’s general level of daytime sleepiness, or average sleep propensity in daily life. The ESS asks people to rate, on a 4-point scale (0, low to 3, high) their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives. The total ESS score provides an estimate of a general characteristic of each person's average level of sleepiness in daily life (0= no chance of dozing/no daytime sleepiness to 24=high chance of dozing/lots of daytime sleepiness).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up|||units on a scale||Inter-Quartile Range|Median
1349223|NCT01808339|Secondary|Peak Expiratory Flow (PEF)|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. AM and PM pre-treatment PEF was measured throughout the study for the purposes of monitoring participants’ asthma stability, and was measured from the start of the Run-in Period until completion of Treatment Period 3 (including during the washout periods), prior to study medication and/or any rescue albuterol/salbutamol inhalation aerosol use. The data collected were only assessed by the Investigator on an individual basis during the study and were not formally summarized or statistically analyzed; consequently, data are not reported.|Up to 18 weeks|||||||
1349224|NCT01808339|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were collected from the start of dosing with investigational product and until follow-up.|Up to 18 weeks|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
1349225|NCT01808339|Secondary|Pre-treatment AM and PM Trough FEV1 on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). FEV1 PM trough FEV1 values were the values taken pre-treatment on Day 14, and AM trough FEV1 values were the values taken pre-treatment on Day 15 in each treatment period; thus, there is only one value (pre-treatment record) per period for AM and PM trough.|Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants available at the specified time points were analyzed|||Liters||Standard Error|Least Squares Mean
1349226|NCT01808339|Primary|Weighted Mean Forced Expiratory Volume in 1 Second (FEV1) Measured Over 24 Hours at Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at 3, 6, 9, 12, 15, 18, 21, and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of three technically acceptable measurements was recorded. FEV1 weighted mean was analyzed using a mixed effects analysis of a covariance model with fixed effect terms for treatment and period, participant Baseline, period Baseline, gender, and age as covariates, and participant as a random effect.|24 hours post-PM dose on Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
1349227|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||Full Range|Median
1349257|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle volume at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the mean corpuscle volume values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Femtoliters||Standard Deviation|Mean
1349228|NCT01808326|Secondary|Elimination Half-life (t1/2) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||95% Confidence Interval|Geometric Mean
1349229|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Phenyl Acetic Acid Mustard|Blood samples for PK analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
1349230|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
1349231|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||Full Range|Median
1349232|NCT01808326|Secondary|Elimination Half-life (t1/2) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||95% Confidence Interval|Geometric Mean
1349233|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Chlorambucil|Blood samples for PK analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
1349258|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Picogram||Standard Deviation|Mean
1349234|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
1349235|NCT01808326|Secondary|Expression of Complement CH50|Peripheral samples were collected for the analysis of complement CH50 at Baseline (Day 1 of Cycle 1) and after completion of Cycle 4 (Day 85).|Baseline, Cycle 1-Day 1, and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilounit /Liter||Standard Deviation|Mean
1349236|NCT01808326|Secondary|Expression of Beta 2 Microglobulin|Blood samples were collected at the Baseline (Day 1 of Cycle 1) visit for prognostic biomarker Beta 2 microglobulin measurements.|Baseline (Cycle 1 Day 1)|All Subjects Population|||Nanomoles per Liter||Standard Deviation|Mean
1349237|NCT01808326|Secondary|Number of Participants With Positive Minimal Residual Disease (MRD)|MRD refers to the small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR and in whom bone marrow test was performed. A bone marrow sample was examined by flow cytometry (Cluster of differentiation [CD]5, CD19, CD20, and CD23). MRD positive is defined as more than one CLL cell per 10000 leukocytes.|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
1349238|NCT01808326|Secondary|Change From Baseline in the Immunoglobulin(Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.Peripheral samples were collected for the analysis of IgA, IgG, and IgM at Baseline and 28 days after Day 1 of the last treatment cycle (FU 1-PDFU 1) for all participants, and 168 days after day of FU 1-PDFU 1 for participants with CR, PR, and SD. Baseline was the last pre-dose assessment performed on Cycle 1-Day 1. The the last assessment performed prior to pre-dose Cycle 1-Day 1 was used if Cycle 1-Day 1 was missing. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
1349239|NCT01808326|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Adverse Event of Infection or Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Number of participants with a Grade 3 or Grade 4 adverse event of infection or myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
1349240|NCT01808326|Secondary|Number of Participants With Adverse Events by the Indicated Maximum Toxicity Grade|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Non-hematologic AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE V4.03): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
1349241|NCT01808326|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
1349242|NCT01808326|Secondary|Number of Participants With no B-symptoms and With at Least One B-symptom Over Time|The number of participants with no B-symptoms (no night sweat, no weight loss, no fever and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at C1 D1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
1349313|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||percentage of redness|Participants|Standard Deviation|Mean
1349243|NCT01808326|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, Up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was last pre-dose assessment performed on Cycle 1 Day 1(C1 D1). When C1 D1 was missing, the last assessment performed prior to pre-dose C1 D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, Cycle (C) 2-Day (D) 29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1- PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
1349244|NCT01808326|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From the start of treatment until the first administration of the next CLL treatment (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Weeks||95% Confidence Interval|Median
1349245|NCT01808326|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the initial response (CR or PR) until progression or death. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the initial response (CR/PR) until disease progression or death (up to Week 61.1)|All Subjects Population|||Weeks||95% Confidence Interval|Median
1349246|NCT01808326|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as time from the start of treatment until the first response (CR/PR). Time to Response analyses was restricted to the subgroup of the population who experienced an overall response (CR/ nPR/CRi/PR) during the study. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until the first response (CR/PR) (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Weeks||95% Confidence Interval|Median
1349247|NCT01808326|Secondary|Overall Survival (OS)|Overall survival is defined as time from the start of treatment until death due to any cause. Participants who had not died were censored at the date of last contact.|From the start of treatment until death (up to Week 61.1)|All Subjects Population|||Weeks||95% Confidence Interval|Median
1349248|NCT01808326|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator and the IRC|Progression-free survival (PFS) is defined as the time from the start of treatment of investigational product until the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population|||Weeks||95% Confidence Interval|Median
1349249|NCT01808326|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the Investigator, IRC and IRC With CT|OR is defined as the number of participants achieving either a confirmed CR or PR. Assessment was completed by the Investigator, IRC, and IRC with CT. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population|||Participants|||Number
1349250|NCT01808326|Primary|Number of Participants With a Best Response of Either Complete Remission (CR), Nodular Partial Remission (nPR), Complete Remission-incomplete (CRi) or Partial Remission (PR), as Assessed by the Investigator, IRC and IRC With CT|According to the criteria based on the 2008 revision of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) of the National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG), participants with complete remission (CR), nodular partial remission (nPR), complete remission-incomplete (CRi) and partial remission (PR) were classified as responders, while stable disease (SD) and progressive disease (PD) were classified as non-responders. Participants with unknown or missing responses were considered as non-responders. Assessment was completed by the Investigator, Independent Review Committee (IRC), and IRC with Computed Tomography (CT).|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population: all participants who received at least one dose of investigational product.|||Participants|||Number
1349251|NCT01808313|Secondary|Number of Participants With Urinalysis Data at Baseline and Week 24|Urine samples were collected for urinalysis at Baseline and Week 24. The Number of participants with urinalysis to negative and positives (trace, +, ++ and +++) data at Baseline and Week 24 are summarized for urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine nitrite (UNIT), urine protein (UM) and urine urobilinogen (UUBIL) were performed with dipstick method. Other urinalysis parameters included urine pH (UpH), urine specific gravity (USG). The Baseline value is defined as the last pre-treatment value observed.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
1349252|NCT01808313|Secondary|Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/Bun at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/BUN values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimoles per liter||Standard Deviation|Mean
1349253|NCT01808313|Secondary|Mean Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine and uric acid at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the direct bilirubin, total bilirubin, creatinine and uric acid values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Micromoles per liter||Standard Deviation|Mean
1349254|NCT01808313|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH) at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the ALP, ALT, AST, CK, GGT and LDH values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||International units per liter||Standard Deviation|Mean
1349255|NCT01808313|Secondary|Change From Baseline in Albumin, Globulin and Total Protein at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of albumin, globulin and total protein at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the albumin, globulin and total protein values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
1349256|NCT01808313|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of RBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the red blood cell count values were summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Trillion cells per liter||Standard Deviation|Mean
1349314|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.|Baseline||||percentage of redness|Participants|Standard Deviation|Mean
1349259|NCT01808313|Secondary|Change From Baseline in Hematocrit at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hematocrit at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hematocrit values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is defined as the last Pre-treatment value observed. The unit of measure is defined as the proprtion of red blood cells in blood.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Proportion of 1||Standard Deviation|Mean
1349260|NCT01808313|Secondary|Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
1349261|NCT01808313|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Giga cells per liter||Standard Deviation|Mean
1349262|NCT01808313|Secondary|Number of Participants With Shift From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) and Total Bilirubin (BILT) up to Week 24|Blood samples were collected for the measurement of ALT, ALP, AST and BILT at the Baseline visit and up to Week 24. Shift from Baseline (BL) was calculated as the individual maximum of post-BL value minus the BL value. The BL value is defined as the last pre-treatment value observed. Threshold values for the liver function test results, which were considered as potential values of clinical concern, were 3 times the upper limit of normal (ULN) for ALT, AST and ALP and 2 times the ULN for BILT. Maximum liver function abnormal values of post-BL are summarized.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
1349263|NCT01808313|Secondary|Oral Temperature|Oral temperature was used to monitor vital signs and collected at the Screening visit.|Baseline|Safety Population|||Celsius||Full Range|Mean
1349264|NCT01808313|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points up to Week 24|Vital sign monitoring included heart rate measurements at (pre-6MWT and post-6MWT at the Baseline visit, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing value observed before treatment. At Baseline, Weeks 12 and 28, heart rate was recorded at the end of the 6MWT and at 1 minute (M), 2 M and 3 M, after completion of the 6MWT with the participants seated, and the time that heart rate recovered to the level of pre-6MWT.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
1349265|NCT01808313|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at the Indicated Time Points up to Week 24|Blood pressure measurements (pre-6MWT and post-6MWT) were taken to monitor vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in SBP and DBP were summarized for each post-Baseline assessment upto Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1349266|NCT01808313|Secondary|Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24|The ECG parameters, PR interval, QRS duration, uncorrected QT interval, QTcB were measured at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Milliseconds||Standard Deviation|Mean
1350803|NCT01786161|Secondary|Time Required to Reach the Therapeutic Levels|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)||||hours||Standard Deviation|Mean
1349267|NCT01808313|Secondary|Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24|Heart rate was measured in order to monitor vital signs by the 12-lead ECG at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment at Weeks 12 and 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
1349268|NCT01808313|Secondary|Number of Participants With Physical Examination Findings|Complete physical examinations of each participant by the investigator were performed at the Screening Visit, Week 12 and Week 24 Visit/Early withdrawal visits. The physical examination included an examination of the following: general appearance, skin, head, ears, eyes, nose, throat, neck, thyroid, lymph nodes, cardiovascular system, respiratory system, abdomen, musculoskeletal system, neurological system and height. Physical examination summary results were not collected therefore there is no data to present for this outcome measure.|Baseline, Week 12 and Week 24|Safety Population|||Participants|||Number
1349269|NCT01808313|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation|An adverse event (AE) is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, or important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment up to Week 24|Safety Population|||Participants|||Number
1349270|NCT01808313|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from Baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or Investigational product (IP) discontinuation (discon) due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events during 12 and 24 Weeks.|Baseline up to Week 24|Safety Population: This population comprised of all participants who received at least one dose of study medication.|||Participants|||Number
1349271|NCT01808313|Secondary|Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate maker of heart failure and was measured by a central laboratory. Mean change from Baseline at Weeks 12 and 24 were calculated as the Weeks 12 and 24 values minus the Baseline values.Observed data was analyzed (no imputation technique was performed for missing data). Log transformed mean change from Baseline at Weeks 12 and 24 data are summarized.|Baseline, Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by number of participants [n]=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflect everyone in the ITT Population.|||log(ng/L)||Standard Deviation|Mean
1349272|NCT01808313|Secondary|Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from Baseline was calculated as the Week 12 and 24 values minus the Baseline values. The BDI indicates the degree of exertion, breathlessness, fatigue, or difficulty breathing after completion of the 6MWT. The lower values, 0 as the lowest, indicates no exertion, fatigue, or breathlessness felt, and 10 would be the maximum amount of exertion felt as assessed by each participant. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population.|||scores on a scale||Standard Deviation|Mean
1349273|NCT01808313|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|The WHO FC was determined by the investigator as follows: Class I- Participants with pulmonary hypertension (PH) but without resulting limitation of physical activity, II- Participants with PH resulting in slight limitation of physical activity, III- Participants with PH resulting in marked limitation of physical activity, IV- Participants with PH with inability to carry out any physical activity without symptoms. Changes from Baseline in functional class were summarized at Weeks 12 and 24. The number of participants improving by 2 classes, improving by 1 class, not changing, worsening by 1 class or worsening by 2 classes from Baseline at Weeks 12 and 24 were evaluated. The Baseline value was the last non-missing assessment value before treatment. Only participants with non-missing Baseline values and at least one non-missing post-Baseline value of the response variable were included. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population|||Participants|||Number
1349274|NCT01808313|Secondary|Change From Baseline in 6MWT at Week 24|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10%. If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 24|ITT Population.|||Meters||Standard Deviation|Mean
1349286|NCT01808261|Secondary|Change From BL in Hematology- Hemoglobin|Hemoglobin was measured at BL Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. . By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Grams per liter||Standard Deviation|Mean
1350804|NCT01786161|Primary|Number of Participants Who Achieved the Target Vancomycin Concentration|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|24 hours||||Participants|||Count of Participants
1349275|NCT01808313|Primary|Change From Baseline in 6-minutes Walk Test (6MWT) at Week 12|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10 percent (%). If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and had an efficacy assessment performed both at Baseline and after administration of the study medication|||Meters||Standard Deviation|Mean
1349276|NCT01808261|Secondary|Antibodies Against GSK249320, Assessed Using Electrochemi-luminescent Assay (ECL) Assay|Blood samples were collected and the presence of antibodies against GSK249320 was assessed using ECL assays. Positive result indicated presence of antibodies and negative result indicated absence of antibodies. Confirmed samples with presence of antibodies were further characterized for neutralizing activity as binding antibody (BAb) and neutralising antibody (NAb) by a neutralization assay.By-visit sample sizes vary due to missing data or early termination of the study.|Day 1, Day 30, Day 180, EW visit and Follow-up visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1349277|NCT01808261|Secondary|Volume of Distribution (V1 and V2) and Volume at Steady State (Vss) for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. V1, V2 and Vss were derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population|||milliliters/kilogram||Geometric Coefficient of Variation|Geometric Mean
1349278|NCT01808261|Secondary|Clearance (CL) for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. CL was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population.|||Milligrams/kilograms/hour||Geometric Coefficient of Variation|Geometric Mean
1349279|NCT01808261|Secondary|Area Under the Concentration-time Curve From 0 to 5 Days [AUC(0-5d)] and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. AUC (0-5d) and AUC (0-inf) were derived from the plasma concentration-time data. AUC(0-5d) is the model predicted AUC over the planned TAU of 5 days. Only participants in the GSK249320 15 mg/kg group were analyzed.|Pre-dose and post-dose up to Day 180|PK Population.|||Milligrams/milliliter*hour||Geometric Coefficient of Variation|Geometric Mean
1349280|NCT01808261|Secondary|PK as Measured by Plasma Decay Half-life (t1/2) GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. Terminal phase half-life was derived from the plasma concentration-time data. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population.|||Days||Full Range|Median
1349281|NCT01808261|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) GSK249320|Tmax is the time of the occurrence of Cmax. The Cmax is defined as the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Due to early termination of the study data for Tmax was not collected.|Pre-dose and post-dose up to Day 180|PK population. Due to early termination of the study, data for Tmax was not collected||||||
1349282|NCT01808261|Secondary|Maximum Observed Plasma Concentration (Cmax) for GSK249320|Cmax is the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on Day 6. Due to early termination of the study, this data was not collected.|Pre-dose and post-dose up to Day 180|The Pharmacokinetics (PK) population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit. Data not collected due to early termination of study.||||||
1349283|NCT01808261|Secondary|Number of Participants With Suicidal Ideation Via Columbia Suicide Severity Rating Scale (CSSRS)|C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both suicidality behavior and ideation. For Suicidal Ideation (SI), participants were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). SI intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.|Da y 1, Da y 6, Day 30, Day 60, Day 90 and Day 180|Safety Population. Number of participants with at least one on-treatment C-SSRS assessment were included.|||Participants|||Count of Participants
1349284|NCT01808261|Secondary|Change From BL in NIHSS Total Score|The NIHSS is a 15 item, standardized, disease-specific, deficit scale which measures neurological impairment (level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect) and is used to quantify participant status by measuring the severity of the stroke as assessed by NIHSS certified study personnel. The total NIHSS score is calculated as the sum of responses to the 15 items. The total NIHSS score ranges from 0-42, with a higher score indicative of a more severe impairment. By-visit sample sizes vary due to missing data or early termination of the study. Change from BL was calculated as the individual post-Baseline value minus the BL value. BL was defined as the value at Day 1.|BL (Day 1), Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1349285|NCT01808261|Secondary|Change From Baseline in Hematology- Hematocrit|Hematocrit was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1349287|NCT01808261|Secondary|Change From BL in Eosinophils (EOS), Lymphocytes (LYM), Total Absolute Neutrophil Count (ANC), Platelet (PLT) Count, White Blood Cell (WBC) Count|EOS, LYM, Total ANC, PLT count and WBC count were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Giga (10^9 cells) per liter||Standard Deviation|Mean
1349288|NCT01808261|Secondary|Change From BL in Clinical Chemistry- Direct Bilirubin, Total Bilirubin, Creatinine|Direct bilirubin, total bilirubin and creatinine were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
1349289|NCT01808261|Secondary|Change From BL in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)|ALP, ALT and AST were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||International units per liter||Standard Deviation|Mean
1349290|NCT01808261|Secondary|Change From BL in Clinical Chemistry-urea/Blood Urea Nitrogen (BUN), Sodium (Na), Potassium (K), Glucose (Gluc), Chloride (Cl), Calcium (Ca)|Ca, Cl, Gluc, K, Na and BUN were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
1349291|NCT01808261|Secondary|Change From BL in Clinical Chemistry- Albumin and Total Protein|ALB and TP were measured at BL, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Grams per liter||Standard Deviation|Mean
1349292|NCT01808261|Secondary|Change From BL in ECG Parameters|A single 12-lead ECG was obtained at each time point and the following ECG intervals were determined: PR, QRS, QT, RR and corrected QT (QTc), QT interval corrected by Bazett's formula (QTcB), QT interval corrected by Fridericia's formula (QTcF). BL for ECG parameters was the value of Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
1349293|NCT01808261|Secondary|Change From BL in ECG Parameter-Heart Rate|A single 12-lead ECG was obtained at each time point that measured heart rate. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1) Day 6, Day 30 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1349294|NCT01808261|Secondary|Change From BL in Vitals Signs-Heart Rate|Safety was measured by monitoring vital signs including heart rate. The BL for heart rate was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-BL value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study. BL was defined as Day 1.|Day 1, Day 6, Day 180 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1349295|NCT01808261|Secondary|Change From BL in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Safety was measured by monitoring vital signs including blood pressure. The BL for DBP and SBP was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1) , Day 6, Day 180 and early withdrawal (EW) visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1349296|NCT01808261|Secondary|Number of Participants With Events Common to Stroke|Events common to stroke were those events that commonly occurred after a stroke and are generally associated with the underlying stroke or the progression of stroke. These included joint or soft tissue pain, bladder incontinence, depression/mood disorder, urinary tract infection, dysphagia, bowel incontinence, dysarthia, confusion, spasticity, limb edema, aspiration pneumonia, hemorrhagic transformation (symptomatic or asymptomatic), pressure ulcers, progression of stroke, malnutrition, deep vein thrombosis, brain herniation, pulmonary embolism, seizures, and falls.|From Day 1 until early withdrawal, death, Month 6/Day 180|Safety Population.|||Participants|||Count of Participants
1349297|NCT01808261|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or all events of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment is exercised in other situations.|Up to 14 months|Safety population.|||Participants|||Count of Participants
1349298|NCT01808261|Secondary|Number of Falls Over Time|The number of participants who experienced 1, 2, 3 or >=4 falls between BL to Day 90 and BL to Day 180 is summarized. By-visit sample sizes vary due to missing data or early termination of the study. The participants who experienced atleast one-fall were reported|BL (Day 1), Day 90 and Day 180|Safety Population.|||Participants|||Count of Participants
1349300|NCT01808261|Secondary|Change From BL in Dexterity as Measured by Box and Blocks Test|Dexterity is ability of person to use hands skillfully in performing a task. Box and Blocks test is an objective, gross manual dexterity test in individuals with upper limb impairments. Participants were asked to move small wooden blocks from one side of a partitioned box to other. The score was determined by number of blocks transferred within a 60 second time period. Both affected and unaffected arms were tested, starting with the unaffected arm. Change from BL was calculated as the individual post- BL value minus BL value. A higher number of displaced blocks indicated a better gross dexterity and a low number of displaced blocks indicated poor gross dexterity. It was analyzed using fixed effects for treatment, visit, treatment by visit interaction, sex, age, Baseline National Institute of Health stroke scale (NIHSS) total score, BL number of blocks transferred by the affected and unaffected arms, country and presence of concomitant medications that potentially impact recovery.|BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180|PP Population.|||Number of blocks||Standard Error|Least Squares Mean
1349301|NCT01808261|Secondary|Number of Participants With Indicated Transition From One Gait Velocity Category to Another Category at the Indicated Time Points|Participants were categorized at each visit into the following gait velocity categories: 0 m/s, >0 to <0.4 m/s, >=0.4 m/s to 0.8 m/s and >0.8m/s. A distinction was made between participants who are too incapacitated to walk (i.e., gait velocity = 0m/s) and participants for whom the gait velocity assessment was not performed due to another reason (i.e., truly missing data). Participants were asked to walk at their usual or normal pace and using their normal assistive devices. Two trials of gait velocity were conducted at each time point. The number of participants transitioning from one gait velocity category to another category was assessed at each post-Baseline visit and was presented in terms of the following transition categories: worsened, no change, improved 1 level, improved 2 levels and improved 3 levels. By-visit sample sizes vary due to missing data or early termination of the study, missing data was not imputed.|BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180.|PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments. Only participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1349302|NCT01808261|Secondary|Mean Change From BL to Month 6/ Day 180 in Gait Velocity|Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 m distance and were allowed to use their normal assistive devices. The time (s) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.|BL (Day 1) and Month 6/Day 180|ITT Population.|||m/s||Standard Deviation|Mean
1349303|NCT01808261|Primary|Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity|Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter (m) distance and were allowed to use their normal assistive devices. The time (seconds[s]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.|BL (Day 1) and Month 3/Day 90|Intent-To-Treat (ITT) population comprised of participants who received at least 1 infusion of investigational product and had at least 1 post-Baseline efficacy assessment.|||m/s||Standard Deviation|Mean
1349304|NCT01808248|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1349305|NCT01808248|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 12 weeks|Full Analysis Set|||percentage of participants|||Number
1349306|NCT01808248|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1349307|NCT01808248|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1349308|NCT01808248|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1349309|NCT01808209|Primary|Wettability|Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||seconds|Participants|Standard Deviation|Mean
1349315|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
1349316|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||logMAR||Standard Deviation|Mean
1349317|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.|Dispense|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||logMAR||Standard Deviation|Mean
1349318|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.|Baseline||||logMAR||Standard Deviation|Mean
1349319|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|1 Week||||units on a scale||Standard Deviation|Mean
1349320|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|Baseline||||units on a scale||Standard Deviation|Mean
1349321|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
1349322|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|Baseline||||units on a scale||Standard Deviation|Mean
1349323|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
1349324|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|Baseline||||units on a scale||Standard Deviation|Mean
1349325|NCT01808209|Primary|Dryness|Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
1349326|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.|Baseline|Prior to randomization|||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
1349327|NCT01808209|Primary|Dryness|Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
1349328|NCT01808209|Primary|Comfort|Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
1349329|NCT01808209|Primary|Comfort|Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
1349330|NCT01808209|Primary|Handling|Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
1349331|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)|1 week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||hours||Standard Deviation|Mean
1349332|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)|Baseline||||hours||Standard Deviation|Mean
1349333|NCT01808144|Secondary|Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus|Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)|Up to approximatley 2.5 years (at Extension Month 12)|ITT Population Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed through Month 12.|||Percentage of participants|||Number
1349334|NCT01808144|Primary|Percentage of Participants With an sUA Level That is < 5.0 mg/dL|Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases|Up to approximately 2.5 years (at Extension Month 12)|Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed Extension Month 12.|||Percentage of participants|||Number
1349358|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.|up to 25 days from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
1349335|NCT01808118|Secondary|Number of Participants Reaching Partial Flare Definition by Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but <2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349336|NCT01808118|Secondary|Number of Participants Reaching Flare Definition by Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349337|NCT01808118|Secondary|Time to Partial Flare at Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but <2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were treated as missing.|||weeks||95% Confidence Interval|Median
1349338|NCT01808118|Secondary|Time to Flare at Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were treated as missing.|||weeks||95% Confidence Interval|Median
1349339|NCT01808118|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at Weeks 28 and 68|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||units on a scale||Standard Deviation|Mean
1349340|NCT01808118|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Weeks 28 and 68|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349341|NCT01808118|Secondary|Number of Participants Achieving ASAS Partial Remission at Weeks 28 and 68|"Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of < 2 units on a 0 to 10 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349342|NCT01808118|Secondary|Number of Participants Achieving an ASAS 5/6 Response at Weeks 28 and 68|"An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:~Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);~Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);~High-sensitivity C-reactive protein level (lower levels = less inflammation)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349343|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Weeks 28 and 68|"ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349344|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Weeks 28 and 68|"ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349345|NCT01808118|Secondary|Number of Participants Achieving ASDAS Clinically Important Improvement at Weeks 28 and 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ –1.100.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349359|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set|The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set.|up to 25 days from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349486|NCT01807234|Secondary|Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability|Participants’ self-assessment of disability was assessed using 4-point scales (none, mild, moderate, and severe). A binary outcome variable was created grouping none and mild vs moderate to severe. .|2-hours||||percentage of patients||95% Confidence Interval|Number
1349346|NCT01808118|Secondary|Number of Participants Achieving ASDAS Major Improvement at Weeks 28 and 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ –2.000.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349347|NCT01808118|Secondary|Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at Weeks 28 and 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of <1.300.|Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349348|NCT01808118|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at 12 Weeks After Initiation of Rescue Therapy|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||units on a scale||Standard Deviation|Mean
1349349|NCT01808118|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at 12 Weeks After Initiation of Rescue Therapy|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349350|NCT01808118|Secondary|Number of Participants Achieving ASAS Partial Remission at 12 Weeks After Initiation of Rescue Therapy|"Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of < 2 units on a 0 to 10 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349351|NCT01808118|Secondary|Number of Participants Achieving an ASAS 5/6 Response at 12 Weeks After Initiation of Rescue Therapy|"An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:~Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);~Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);~High-sensitivity C-reactive protein level (lower levels = less inflammation)."|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349487|NCT01807234|Secondary|Absence of Allodynia|5) Absence of allodynia The presence of allodynia was assessed based on a series of 8 questions inquiring as to the presence of allodynia. Participants answering 2 or more questions positively were considered to have allodynia.|2-hours||||percentage of patients||95% Confidence Interval|Number
1349352|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at 12 Weeks After Initiation of Rescue Therapy|"ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349353|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at 12 Weeks After Initiation of Rescue Therapy|"ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349354|NCT01808118|Secondary|Number of Participants Achieving ASDAS Clinically Important Improvement at 12 Weeks After Initiation of Rescue Therapy|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ –1.100.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349355|NCT01808118|Secondary|Number of Participants Achieving ASDAS Major Improvement at 12 Weeks After Initiation of Rescue Therapy|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ –2.000.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349356|NCT01808118|Secondary|Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at 12 Weeks After Initiation of Rescue Therapy|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of <1.300.|Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
1349357|NCT01808118|Primary|Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
1349488|NCT01807234|Secondary|Absence of Nausea|4) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours||||percentage of patients||95% Confidence Interval|Number
1349360|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.|up to 25 days from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349361|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28.|at Day 28 from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
1349362|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349363|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349364|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
1349365|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349366|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349367|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)|||participants with favorable responses|||Number
1349368|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)|||participants with favorable responses|||Number
1349369|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)|||participants with favorable responses|||Number
1349370|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)|||participants with favorable responses|||Number
1349371|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)|||participants with favorable responses|||Number
1349372|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)|||participants with favorable responses|||Number
1349373|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC|||participants|||Number
1349374|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC|||participants|||Number
1349375|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC|||participants|||Number
1349376|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT|||participants|||Number
1349489|NCT01807234|Secondary|Absence of Phonophobia|3) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours||||percentage of patients||95% Confidence Interval|Number
1349490|NCT01807234|Secondary|Absence of Photophobia|2) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours||||percentage of patients||95% Confidence Interval|Number
1349377|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT|||participants|||Number
1349378|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT|||participants|||Number
1349379|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)|||participants|||Number
1349380|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)|||participants|||Number
1349381|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)|||participants|||Number
1349382|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)|||participants|||Number
1349383|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)|||participants|||Number
1349384|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)|||participants|||Number
1349385|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)|||participants with favorable responses|||Number
1349386|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
1349387|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
1349388|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)|||participants with favorable responses|||Number
1349389|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
1349390|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
1349391|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
1349392|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
1349491|NCT01807234|Secondary|Pain Freedom|1) Pain Freedom: Pain Freedom at 2 hours is defined as being free of pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).|2-hours||||percentage of patients||95% Confidence Interval|Number
1349393|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
1349394|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
1349395|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349396|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349397|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
1349398|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
1349399|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
1349400|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349422|NCT01807949|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.|||percentage of participants|||Number
1349401|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349402|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
1349403|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
1349404|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349405|NCT01808092|Primary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
1349406|NCT01808092|Primary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
1349407|NCT01808066|Other Pre-specified|Post Interview With Teachers to Qualitatively Assess Interest in Using the Game With Students and Any Improvements to be Made|Researchers will ask teachers for qualitative feedback once participants have completed game play about interest in using the game and any improvements to be made.|Day 21|||||||
1349408|NCT01808066|Other Pre-specified|Post Interview With Participants to Qualitatively Identify Themes of Interest and Quality of Life Effects|After playing game for three weeks, researchers will interview participants about their interest in the game and changes in quality of life (no forms).|Day 21|||||||
1349409|NCT01808066|Other Pre-specified|Pre Interview With Teachers to Qualitatively Identify Themes of Motivation and Interest|Researchers will conduct interviews with teachers and collect all notes/journals recorded. Specific questions will be asked about their perception of participant's attention, interest and motivation to play the game. Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1|||||||
1349410|NCT01808066|Secondary|Pre Interview With Participants to Qualitatively Identify Interest and Motivation|Researchers will conduct interviews with players and collect all notes/journals recorded. Specific questions will be asked about their perception of their attention, interest and motivation to play the game. Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1|||||||
1349411|NCT01808066|Primary|Number of Participants With an Increase/Improvement in Focusing|Researchers will observe and record data during the first play session. Over the three weeks, teachers/support staff will be asked to observe players each day and record their observations as needed in a journal. These observations will measure their improvement in their ability to focus by assessing their engagement, time played, frequency of play, ability to complete a session and ability to start and finish a session. At the end of three weeks, researchers will attend the final play session and record observations in writing.|3 weeks||||participants|||Number
1349492|NCT01807234|Primary|2- Hour Pain Relief|The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)|2 hours||||percentage of participants||95% Confidence Interval|Number
1349412|NCT01807949|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough,avg, C3-6h, and C3-6h,avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,avg is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough,avg is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1349413|NCT01807949|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug. Participants were analyzed as per actual treatment received.|||participants|||Number
1349414|NCT01807949|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."|||units on a scale||Standard Error|Least Squares Mean
1349415|NCT01807949|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant’s self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1349416|NCT01807949|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1349417|NCT01807949|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.|||percentage of participants|||Number
1349418|NCT01807949|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression method. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.|||days||Full Range|Median
1349419|NCT01807949|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.|||z-score||Standard Error|Least Squares Mean
1349420|NCT01807949|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Error|Least Squares Mean
1349421|NCT01807949|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.|||pulmonary exacerbation events per year|||Number
1349557|NCT01806623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.|||hours||Full Range|Median
1349423|NCT01807949|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1349424|NCT01807949|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
1349425|NCT01807949|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1349426|NCT01807949|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Error|Least Squares Mean
1349427|NCT01807923|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough, avg, C3-6h, and C3-6h, avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough, ave is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1349428|NCT01807923|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Treatment-Emergent Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Nonserious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug.|||participants|||Number
1349429|NCT01807923|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants’ experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."|||units on a scale||Standard Error|Least Squares Mean
1349430|NCT01807923|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant’s self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1349431|NCT01807923|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1349432|NCT01807923|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.|||percentage of participants|||Number
1349433|NCT01807923|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.|||days||Full Range|Median
1349434|NCT01807923|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from –infinity to + infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using Centers for Disease Control and Prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.|||z-score||Standard Error|Least Squares Mean
1349435|NCT01807923|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Error|Least Squares Mean
1349436|NCT01807923|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.|||pulmonary exacerbation events per year|||Number
1349437|NCT01807923|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.|||percentage of participants|||Number
1349438|NCT01807923|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1349439|NCT01807923|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
1349440|NCT01807923|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
1349441|NCT01807923|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at Week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Error|Least Squares Mean
1349442|NCT01807871|Secondary|Adverse Drug Effects|To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal.|Up to 12 weeks|All randomized participants|||Participants|||Count of Participants
1349443|NCT01807871|Secondary|Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence|To test whether the amount of use of nicotine patch post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.|4 months after the quit date|Because the results for the primary outcome were negative, this outcome was not analyzed (i.e., there was no effect to mediate).||||||
1349444|NCT01807871|Primary|Point-prevalent Abstinence at 4 Months|"To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question In the last 7 days, on how many days did you smoke on the 4 month follow-up survey. Respondents who replied 0 were classified as Yes for 7-day point-prevalent abstinence; all other responses (including missing) were classified as No."|4 months after the quit date|Participants who lapsed while using the nicotine patch|||Participants|||Count of Participants
1349445|NCT01807650|Secondary|Adverse Events by Relationship to Study Medication|Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'.|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
1349446|NCT01807650|Secondary|Severity of Adverse Events|Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5).|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
1349447|NCT01807650|Secondary|Frequency of Adverse Events||Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
1349448|NCT01807650|Secondary|Pharmacokinetic (PK) Data (Plasma Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL|up to 4 weeks|A total of 13 participants had a total of 15 samples with betulin concentrations above the LLOQ (1 ng/mL), 2 participants with 2 samples each above LLOQ|||Betulin (ng/mL)|Samples above LLOQ|Full Range|Mean
1349449|NCT01807650|Secondary|Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL.|up to 4 weeks|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Plasma Samples|Plasma Samples||Number
1349450|NCT01807650|Secondary|Likert Scale Rating of Tolerability|Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, non-adhesive wound dressing only is better tolerated, non-adhesive wound dressing only is much better tolerated).|2 to 4 weeks|The safety analysis population (SAF) included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Percentage of participants|||Number
1349451|NCT01807650|Secondary|Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively|Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation.|3 months and 12 months|"The intent-to-treat (ITT) analysis population included 96 participants for the 3-months follow-up and 65 participants for the 12-months follow-up.~*Note: The assessment for one patient was missing as no photo was not taken at the Month 3 follow-up visit, therefore this outcome measure is based on 95 patients"|||Percentage of wounds||95% Confidence Interval|Number
1349452|NCT01807650|Secondary|Likert Scale Rating of Efficacy|Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective).|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage of efficacy assessments||95% Confidence Interval|Number
1349453|NCT01807650|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator|A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28.|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Area Percent of initial wound size||95% Confidence Interval|Mean
1349454|NCT01807650|Secondary|Percentage of Participants With Wound Closure at Different Time Points|For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated.|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=2 participants at all time points.|||Percentage with wound closure||95% Confidence Interval|Number
1349455|NCT01807650|Secondary|Percentage of Participants With Earlier Healing|Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage with earlier healing||95% Confidence Interval|Number
1349472|NCT01807585|Secondary|Intraoperative Pain|After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.|During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.|Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.|||scores on a scale||Standard Deviation|Mean
1349558|NCT01806623|Secondary|Maximum Observed Plasma Concentration (Cmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1349456|NCT01807650|Secondary|Time From Surgery Until Wound Closure is Achieved|Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 110 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 2 of the 110 wounds data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only).|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. For 2 of the 110 wounds, data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention|||Days from surgery until wound closure|STSG Wound (Halves)|95% Confidence Interval|Mean
1349457|NCT01807650|Primary|Intra-individual Difference in Time to Wound Closure|Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as [time taken for wound half treated with Oleogel-S10 to close] - [time taken for wound half treated with non-adhesive wound dressing to close], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant.|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||days||95% Confidence Interval|Mean
1349458|NCT01807624|Secondary|SpO2 Decrease of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349459|NCT01807624|Secondary|SpO2 Increase of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349460|NCT01807624|Secondary|Decrease in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349461|NCT01807624|Secondary|Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349462|NCT01807624|Secondary|Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349463|NCT01807624|Secondary|Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349464|NCT01807624|Secondary|Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349465|NCT01807624|Secondary|Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
1349466|NCT01807624|Primary|AUC0-infinity of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||ng*h/mL||Standard Deviation|Mean
1349467|NCT01807624|Primary|AUC0-t of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||ng*h/mL||Standard Deviation|Mean
1349468|NCT01807624|Primary|Half-life of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||minutes||Standard Deviation|Mean
1349469|NCT01807624|Primary|Tmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||minutes||Standard Deviation|Mean
1349470|NCT01807624|Primary|Cmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||ng/mL||Standard Deviation|Mean
1349471|NCT01807585|Secondary|Ecchymosis at Day 3|"At the Day 3 visit, the investigator visually rated the subject’s ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome.~The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site.~The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria:~0 rating = no ecchymosis,~rating = less than 25% ecchymosis,~rating = 25-50% ecchymosis,~rating = 50-75% ecchymosis,~rating = 75-100% ecchymosis,~rating = extension of ecchymosis above or below the treated area."|First follow up visit at day 3|Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.|||Participants|||Count of Participants
1349485|NCT01807234|Secondary|Sustained Pain Relief (SPR)|7) 24 and 48 hours sustained pain relief (SPR) Defined as the reduction of pain to none or mild from moderate or severe, on a 4-point scale (none, mild, moderate, and severe).|24 and 48 hours||||percentage of patients||95% Confidence Interval|Number
1349473|NCT01807585|Primary|Number of Participants With Complete Closure of the Target Vein at 3 Months|The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.|3 months|Primary effectiveness was analyzed on the randomized cohort only and used an Intent to Treat (ITT) population, consisting of all treated subjects. The difference in success rates was calculated after imputing missing values with various methods.|||Participants|||Count of Participants
1349474|NCT01807520|Secondary|Number of Participants Who Develop Immunogenicity Against Secukinumab|The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive.|Week 132|Participants from the safety set was analyzed. The safety set included all participants who took at least one dose of study treatment.|||Participants|||Number
1349475|NCT01807520|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline.|16 weeks, 132 weeks|Participants from the FAS, who had evaluable data at a given time point, were analyzed for that time point. The FAS consisted of all randomized participants to whom treatment was assigned. Multiple imputation was applied where the number of evaluable participants was based on a rounded mean number of responders for 500 imputations.|||Percentage of participants|||Number
1349476|NCT01807520|Secondary|Percent Change From Baseline in NAPSI Score|The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement.|baseline, 16 weeks, 132 weeks|Only participants from the full analysis set (FAS) who had values at both baseline and the post-baseline time point, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).|||percent change||Standard Deviation|Mean
1349477|NCT01807520|Primary|Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment|The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.|Baseline, 16 weeks|Only participants from the full analysis set (FAS) who had values at both baseline and week 16, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).|||percent change||Standard Error|Mean
1349478|NCT01807455|Secondary|Adverse Event Reporting During the Study|Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)|36 weeks||||participants|||Number
1349479|NCT01807455|Secondary|Assessment of Local Tolerability After Treatment|Number of subjects reporting anticipated injection-related reactions after treatment|14 days||||participants|||Number
1349480|NCT01807455|Secondary|Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)|Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.|36 weeks||||percentage of participants|||Number
1349481|NCT01807455|Secondary|Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire|Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.|36 weeks||||percentage of participants|||Number
1349482|NCT01807455|Primary|Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale|Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.|36 weeks||||percentage of participants|||Number
1349483|NCT01807234|Secondary|Time to Pain Relief|9) The time, in minutes, will be measured from the time study drug is taken to the time when significant pain relief is first observed and maintained through 2 hours with no rescue medication use at or prior to this point.|following each treated migraine attack||||percentage of patients||95% Confidence Interval|Number
1349484|NCT01807234|Secondary|Sustained Pain Freedom (SPF)|8) 24 and 48 hours sustained pain freedom (SPF); Defined as the reduction of pain to none. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).|24 and 48 hours||||percentage of patients||95% Confidence Interval|Number
1349493|NCT01807156|Secondary|Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Measurable lesions: Lesions that can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan.~Non-measurable lesions: All other lesions including small lesions (longest diameter < 20 mm with conventional techniques) and other non-measurable lesions including: pleural effusions, ascites, and disease documented by indirect evidence (e.g. biochemical abnormalities).~Target lesions: All measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.~Non-target lesions: All other lesions are identified as non-target lesions and should be followed as present or absent."|6 months|No response was observed in any of the patients.|||participants|||Number
1349494|NCT01807156|Primary|Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression|Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are all measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.|6 Months||||participants|||Number
1349495|NCT01807000|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||percentage of radioactivity||Standard Deviation|Mean
1349496|NCT01807000|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate||240 hours post-dose|Pharmacokinetic Analysis Set|||percentage of radioactvity||Standard Deviation|Mean
1349497|NCT01807000|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
1349498|NCT01807000|Primary|Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Full Range|Median
1349499|NCT01807000|Primary|Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents/ml||Standard Deviation|Mean
1349500|NCT01807000|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents*h/ml||Standard Deviation|Mean
1349501|NCT01807000|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
1349502|NCT01807000|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Full Range|Median
1349503|NCT01807000|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents/ml||Standard Deviation|Mean
1349504|NCT01807000|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents*h/ml||Standard Deviation|Mean
1349505|NCT01807000|Primary|Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate|The distribution of a medication between plasma and the rest of the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||Liters||Standard Deviation|Mean
1349506|NCT01807000|Primary|Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate|The rate at which a drug is removed from the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||L/h||Standard Deviation|Mean
1349507|NCT01807000|Primary|Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate|The time it takes for the blood plasma concentration of a substance to halve.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
1349508|NCT01807000|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Full Range|Median
1349509|NCT01807000|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng/ml||Standard Deviation|Mean
1349510|NCT01807000|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|The Pharmacokinetic Analysis Set included all subjects with at least 1 pharmacokinetic parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set which included all subjects who took 1 dose of investigational product, underwent plasma pharmacokinetic sampling, and had evaluable pharmacokinetic assay results.|||ng*h/ml||Standard Deviation|Mean
1349511|NCT01806961|Secondary|Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area|recording of adverse events|at 6 and 12 months|||||||
1349512|NCT01806961|Secondary|Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)|clinical examination|at 6 and 12 months|||||||
1349513|NCT01806961|Primary|Determine the Recurrence Rate of AK-lesions|Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.|at 6 and 12 months|No subject was analysed due to premature study termination (sponsor's decision) therefore no data was available for analysis||||||
1350884|NCT01785524|Primary|Change in Exercise Capacity - Time to Exhaustion (TTE)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)|Baseline & 16 Weeks||||seconds||Standard Deviation|Mean
1349514|NCT01806896|Secondary|Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)|This incentive force task was developed to independently dissociate the degree to which a participant responds to reward motivation versus emotional motivation. The task itself included 12 repetitions of 9 trial types, for a total of 108 trials, grouped in a single session lasting about 20 minutes. The trial types were generated according to a combination of 3 emotional categories (negative, neutral, and positive pictures presented) and to 3 monetary incentives (0.01, 0.1, and 1€). Emotional categories and monetary incentives were randomly distributed over the trials and the sequence was fixed such that all subjects were assessed on the exact same task. For each trial, the subject was first presented with an emotional picture displayed on screen for 3000 milliseconds (ms).|Baseline, Day 28|The analysis population included all participants randomized, who had taken at least 1 dose of PF-02545920 or placebo and who had valid data (acceptable task engagement). n=number of participants analyzed in the respective arms. The PPS table was used, not the FAS table.|||percentage of MVC||90% Confidence Interval|Least Squares Mean
1349515|NCT01806896|Primary|Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category.|Day 28|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349516|NCT01806896|Primary|Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category.|Day 7|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349517|NCT01806896|Secondary|Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28|The monetary incentive delay (MID) task is established as a reliable method to elicit ventral striatal (VS) activity in relation to reward/punishment anticipation and tracked with dysfunctionalities across a range of conditions in which incentive motivation is thought to be abnormal (schizophrenia, depression, substance abuse, and pathological gambling). Pharmacological intervention has demonstrated reversal of observed deficit. The beta contrast value of ’REW’ is for analysis of reward-related activity in VS within the task-related ’reward network’ during the gain condition (relative to neutral) of the MID task. The changes in beta contrasts (fMRI) provided are changes in parameter estimates and do not have a unit of measure.|Baseline (Day 1), Day 28|The analysis population included all participants randomized, who had taken at least 1 dose of PF-02545920 or placebo and who had valid data (thresholded by acceptable motion). n=number of participants analyzed in the respective arms. The per-protocol set (PPS) table was used, not the full analysis set (FAS) table.|||beta contrasts||90% Confidence Interval|Least Squares Mean
1349518|NCT01806896|Primary|Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category.|Baseline (Day 1)|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349519|NCT01806896|Primary|Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28|The UHDRS is a clinical rating scale to provide a uniform assessment of the clinical features and course of Huntington Disease. The Total Motor Score (TMS) is 1 of the 6 components of UHDRS, includes 31 items, and ranges from a scale of 0 to 124 (higher scores indicate more severe disease).|Baseline, Day 28|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||units on a scale||90% Confidence Interval|Least Squares Mean
1349520|NCT01806896|Primary|Categorical Summary of Participants Meeting Stopping Criteria|Absolute neutrophil count (ANC) and WBC were monitored for safety. Participants with WBC <3000 but >=2000 cells/mm^3 or ANC <1500 but >=1000 cells/mm^3 were to have study treatment suspended. Participants with WBC <2000 or ANC <1000 cells/mm^3 were to be discontinued from study participation.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349521|NCT01806896|Primary|Number of Participants With Change From Baseline in Body Weight of >=7%|Weight assessment was performed by a study physician or a trained study nurse and was included in the physical examination.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349522|NCT01806896|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS complex, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval ≥200 milliseconds (msec) or ≥25% increase when baseline is >100 msec; QRS interval ≥50% increase from baseline when baseline is less than or equal to (<=)200 msec; and QTcF ≥450 msec or ≥30 msec increase from baseline.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349578|NCT01806545|Secondary|Percentage of Participants With Loss of Secondary Patency|The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
1349523|NCT01806896|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349524|NCT01806896|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality)|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total and direct bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine/serum pregnancy test, glycosylated hemoglobin [HbA1c, if diabetic]).|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349525|NCT01806896|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to the follow-up period that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
1349526|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Left Leg|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
1349527|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Right Leg|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
1349528|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Left Arm|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
1349529|NCT01806857|Secondary|Average Solids Swallowing Test|The Time Swallowing Test assesses the subject's ability to swallow solids. For this test, the subject will be asked to consume a tablespoon of cereal containing 5 cheerios. The subject will be instructed to close their mouth, chew and subsequently swallow the bolus. The time to complete this task will be recorded. The test will be completed three times to obtain an average score.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||seconds||Standard Error|Least Squares Mean
1349530|NCT01806857|Secondary|Visual Analog Scale - Salivation (Sialorrhea) Score|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349531|NCT01806857|Secondary|Visual Analog Scale - Swallowing Score|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349532|NCT01806857|Secondary|Average Water Swallowing Test (WST)|The Water Swallowing Test (WST) estimates swallowing speed, a useful and reproducible measure. While sitting, subjects are asked to drink 30 milliliters (mL) of liquid. The time for subjects to complete this task is a sensitive measure for the detection of swallowing dysfunction and is a simple measure for serial assessment of subjects. The test will be completed three times, with the best two scores recorded to obtain an average score. Following completion of the WST, the subject's swallowing abilities (choking, spillage, and effort) will be observed.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||seconds||Standard Error|Least Squares Mean
1349622|NCT01805089|Primary|Compliance|To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.|4 months||||participants|||Number
1349533|NCT01806857|Secondary|Timed Reading of Test Paragraph Result|Subjects will be asked to read 'The Rainbow Passage' a commonly used test paragraph utilized by speech pathologists to assess speech rate (words/minute). Study staff will time the subject to determine how many words the subject reads per minute. It is used primarily because it contains every sound in the English language. Subjects will also be observed for loudness, nasality, and intelligibility.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||words per minute||Standard Error|Least Squares Mean
1349534|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Right Arm|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
1349535|NCT01806857|Secondary|Visual Analog Scale - Speech Scores|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349536|NCT01806857|Secondary|ALS Functional Rating Scale- Revised (ALSFRS-R) Total Score|The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349537|NCT01806857|Secondary|Center for Neurologic Study - Lability Scale (CNS-LS) Total Score|The Center for Neurologic Study-Lability Scale (CNS-LS) is a 7-item self report scale that assesses pseudobulbar affect (PBA) by measuring the perceived frequency of PBA episodes (laughing or crying). Each item is scored using a 5-point Likert scale, from 1 (applies never) to 5 (applies most of the time). Scores range from 5-35. The higher the score, the worse the PBA.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349538|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Swallowing Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the swallowing. There are 7 swallowing questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349539|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Speech Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the speech. There are 7 speech questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349540|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Sialorrhea Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the salivation (sialorrhea). There are 7 salivation (sialorrhea) questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349541|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Total Score|"The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the speech, swallowing and salivation (sialorrhea). [Range of score: 21-105]~The scale was modeled on the Center for Neurologic Study Emotional Lability Scale (CNS-LS) that has been a robust endpoint in four clinical trials. The scale was validated in a large population of ALS patients (n=122) and detects impaired bulbar function at a sensitivity of 90% and a specificity of 0.97%. Test re-test correlation was 0.92% at six-months (n=53)."|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
1349542|NCT01806779|Other Pre-specified|Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day|A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).|||percentage of change||Standard Error|Mean
1349623|NCT01805089|Primary|Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo|Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.|4 months||||pg/ml||Standard Deviation|Mean
1349543|NCT01806779|Secondary|Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit|This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) <10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Quit Day to 11-week post Quit Day study visit||||participants|||Number
1349544|NCT01806779|Secondary|Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day|This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.|6 months post Quit Day||||participants|||Number
1349545|NCT01806779|Primary|Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits|This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) <10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Period between 8-week and 11-week visits post target Quit Day||||participants|||Number
1349546|NCT01806714|Secondary|Percentage of Participants Receiving HPV Vaccination (Dose 3)|Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function|9 months|Only subjects with valid phone numbers were included and not all recipients got the 2nd dose. Only subjects who got the 2nd dose were then given the 3rd dose and only if they had working phone numbers.|||percentage of eligible participants|||Number
1349547|NCT01806714|Secondary|Percentage of Participants Receiving HPV Vaccination (Dose 2)|Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function|9 months|Only subjects with a valid phone number at the time dose 2 was dispensed received the vaccine. The number of subjects receiving dose 2 is higher than dose 1 because some phones numbers that were inactive during dose 1 were active during dose 2.|||percentage of eligible participants|||Number
1349548|NCT01806714|Primary|Percentage of Participants Receiving HPV Vaccination (Dose 1)|Participants who received HPV vaccine dose 1 Kaplan-Meier failure function|9 months|Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.|||percentage of eligible participants|||Number
1349549|NCT01806662|Primary|Proportion of SCORAD-50 Response at Week 16.|"Greater improvement from their baseline objective SCORAD (SCORing Atopic Dermatitis) at Week 16. The efficacy variable for each randomized group is the proportion of subjects who achieve an improvement of 50% or greater from their baseline objective SCORAD at Week 16 (at crossover). SCORAD-50 is the percentage of decrease in baseline SCOARD at Week 16.~SCORAD is a clinical tool used to assess the extent and severity of eczema. Calculation is based on extent of involvement (skin involvement) and subjective symptoms of itching and loss of sleep. The SCORAD scale ranges from 0 (minimum, lowest possible score, Mild severity) to 103 (maximum, highest possible score, Severe severity) [last observation carry forward]."|Week 16|Proportion of participants with improved outcome.|||Participants|||Count of Participants
1349550|NCT01806623|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1349551|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||hrs||Full Range|Median
1349552|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1349553|NCT01806623|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg*h/g||Geometric Coefficient of Variation|Geometric Mean
1349554|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||hours||Full Range|Median
1349555|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg/g||Geometric Coefficient of Variation|Geometric Mean
1349556|NCT01806623|Secondary|Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1349559|NCT01806623|Secondary|Total Scores for Clinical Symptoms|Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).|Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||score on s scale||Full Range|Mean
1349560|NCT01806623|Secondary|Mycological Efficacy: Eradication Rate|"Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate.~Eradication rate was calculated based on the following formula, the number of participants assessed as Eradication over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
1349561|NCT01806623|Secondary|Clinical Efficacy: Cure and Improvement Rate|"Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).~Cure and improvement rate was calculated based on the following formula, the number of participants assessed as Cure or Improvement over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
1349562|NCT01806623|Secondary|Clinical Efficacy: Cure Rate|"Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).~Cure rate was calculated based on the following formula, the number of participants assessed as Cure over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
1349563|NCT01806623|Primary|Therapeutic Outcome: Response Rate|"Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication.~Primary evaluation of therapeutic outcome was on Day 28.~Response rate was calculated based on the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
1349564|NCT01806597|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|To investigate the development of immunogenicity against secukinumab|Over time up to week 132|FAS|||Participants|||Count of Participants
1349565|NCT01806597|Secondary|Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set|Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).|Week 16, Week 32, Week 80, Week 132|FAS|||Units on a scale||Standard Deviation|Mean
1349566|NCT01806597|Secondary|Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I|Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).|Week 1, Week 2, Week 4, Week 8, Week 12, Week 16|FAS|||Units on a scale||Standard Deviation|Mean
1349567|NCT01806597|Secondary|Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period|"ppIGA: Palmoplantar Ivestigator’s Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.~Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline)."|Week 16, Week 24, Week 28, Week 80|FAS|||Percentages of participants|||Number
1349577|NCT01806545|Secondary|Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS|B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.|1, 12, and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||millimeters||Standard Deviation|Mean
1349568|NCT01806597|Secondary|Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II|"ppIGA: Palmoplantar Ivestigator’s Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.~Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline)."|Week 16, Week 20, Week 28, Week 32, Week 64, Week 132|FAS|||Percentages of participants|||Number
1349569|NCT01806597|Secondary|Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I|"ppIGA: Palmoplantar Ivestigator’s Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.~Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline)."|Week 1, week 2, week 4, week, 8, week 12, week 16|FAS|||Percentages of participants|||Number
1349570|NCT01806597|Primary|Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment|palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.|Week 16|Full Analysis Set (FAS): The FAS comprised of all patients from the randomized set to who study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization.|||Percentages of participants|||Number
1349571|NCT01806584|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||interventions||Standard Deviation|Mean
1349572|NCT01806584|Secondary|Percentage of Participants With Loss of Secondary Patency|Secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVG placement) until the date of access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||percentage of participants|||Number
1349573|NCT01806584|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|Assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVG placement) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||percentage of participants|||Number
1349574|NCT01806584|Primary|Percentage of Participants With Loss of Unassisted Primary Patency|Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft [AVG] placement) until the first date of (a) any intervention designed to establish, maintain, or restore patency, (b) occlusion (commonly due to thrombosis), or (c) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject’s AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site’s standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The Intent to-Treat (ITT) population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||percentage of participants|||Number
1349575|NCT01806545|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total number of interventions to establish, maintain, or restore patency was recorded for each participant.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||interventions||Standard Deviation|Mean
1349576|NCT01806545|Secondary|Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis|Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
1349624|NCT01804946|Secondary|Percentage of Patients With Complications of the Influenza|Pneumonia, sinusitis, otitis media are examples of the influenza complications|Day 1 to Day 7|Per Protocol set|||Percentage of participants|||Number
1349579|NCT01806545|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
1349580|NCT01806545|Secondary|Percentage of Participants With Loss of Unassisted Primary Patency|The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
1349581|NCT01806545|Secondary|Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination|Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||days||Inter-Quartile Range|Median
1349582|NCT01806545|Secondary|Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
1349583|NCT01806545|Primary|Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.|12 weeks after surgery|The Intent- to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
1349584|NCT01806389|Primary|Infant Plasma Concentrations of Buprenorphine|Infant plasma concentrations of buprenoprhine obtained on day 14 of life|Day 14 of life||||ug/mL||Full Range|Median
1349585|NCT01806389|Primary|Maternal Breast Milk Concentrations of Buprenorphine|Breast milk will be obtained on these days at the time of peak plasma levels of buprenoprhine|Days 2,3,4,14 and 30 after delivery||||ug/mL||Full Range|Median
1349586|NCT01806389|Primary|Maternal Plasma Concentrations of Buprenorphine|Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30|Days 2,3,4,14 and 30 after delivery||||ug/mL||Full Range|Median
1349587|NCT01806298|Other Pre-specified|Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Week 41|The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®.|||Participants|||Count of Participants
1349588|NCT01806298|Secondary|Treatment Adherence Rate as Documented Using EasypodTM Connect|Treatment adherence rate was measured by: (total dose received divided by total dose prescribed) multiplied by 100. Saizen solution for injection was administered using the easypod device and treatment adherence information was obtained from the device using the easypod connect software.|Week 2, 8, 16, 29 and 39|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."|||percentage of treatment adherence||Standard Deviation|Mean
1349625|NCT01804946|Secondary|Change in the Subjective Health Status|The patient subjective health status assessment was based on Visual Analogue Scale − VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).|Day 7 vs. Day 1|Per Protocol set|||Scores on a scale||Standard Deviation|Mean
1349589|NCT01806298|Secondary|Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS)|Insulin-like Growth Factor-1 SDS was calculated based on the actual value of IGF-1 minus reference value of IGF-1 divided by reference standard deviation of IGF-1. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject’s value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated that the IGF-I value was lower compared to the reference population.|Baseline, Week 2, 8, 16, 29, 39 and 41|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."|||Standard deviation score||Standard Deviation|Mean
1349590|NCT01806298|Secondary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels|Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD])|Baseline, Week 2, 8, 16, 29, 39 and 41|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."|||milligram/liter (mg/L)||Standard Deviation|Mean
1349591|NCT01806298|Secondary|Insulin-like Growth Factor-I (IGF-I) Levels|Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD]).|Baseline, Week 2, 8, 16, 29, 39 and 41|The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, “Number Analyzed” signifies those subjects who were evaluable for the specified category at each time point.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
1349592|NCT01806298|Secondary|Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs)|Percentage of subjects with BAbs who become positive for NAbs = (Number of NAb positive subjects / Number of BAbs positive subjects) x 100|Baseline up to Week 39|Data could not be analyzed as there were no subjects who were BAb positive.||||||
1349593|NCT01806298|Primary|Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®|Percentage of subjects developing BAbs = (Number of BAb positive subjects / Total number of subjects) x 100.|Baseline up to Week 39|The modified Intent-To-Treat (mITT) analysis set included all treated subjects who had received at least 1 administration of Saizen® and had at least 1 post-baseline BAbs assessment.|||percentage of subjects||95% Confidence Interval|Number
1349594|NCT01806051|Primary|Changes in Plasma Phe and Tyrosine Levels|To evaluate the patterns of change in plasma Phe and tyrosine levels between the Baseline visit and 4 week visit for each arm.|Baseline and 4 weeks|Participants withdrew before any data were collected.||||||
1349595|NCT01805895|Secondary|Safety Assessment|Adverse events will be asses for 90 days. This will serve as our safety endpoint.|90 days||||adverse events|||Number
1349596|NCT01805895|Primary|Modified Rankin Scale|A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales.|90 days||||units on a scale||Standard Deviation|Mean
1349597|NCT01805882|Primary|The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.|12 weeks after stop of treatment|Subjects who received treatment drugs per arm as listed in the Outcome Measure Description|||percentage of subjects||95% Confidence Interval|Number
1349598|NCT01805687|Secondary|Number of Subjects With Adverse Events||72 Hours|||||||
1349599|NCT01805687|Secondary|Area Under the Curve (AUC)||72 Hours|||||||
1349600|NCT01805687|Primary|Change From Baseline in FEV1||12 Hours||||Liter||Standard Deviation|Mean
1349601|NCT01805440|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) is used to measure suicidal thoughts and behaviors in Investigational New Drug (IND) studies. The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from wish to be dead to active suicidal ideation with specific plan and intent. The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent)."|6 weeks||||Scores on a Scale||Standard Deviation|Mean
1349602|NCT01805440|Primary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Score.|The CDRS-R is a brief rating scale based on a semi-structured interview with the participant (and/or their parent or guardian). The scale can be administered and scored in under 30 minutes. The CDRS-R gives you a single summary score -- with an interpretation of, and clinical recommendations for, six different score ranges. Total possible scores range from 17 to 113, with higher scores indicating more depressive symptoms reported by the participant (and/or their parent or guardian).|6 weeks||||Units on a scale||Full Range|Mean
1349603|NCT01805440|Primary|Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS).|Magnetic Resonance Spectroscopy is a safe, non-invasive method for measuring brain chemicals thought to be involved in mood disorders, such as GLX (glutamate + glutamine). Previous research indicates that adolescents with bipolar depression have elevated Glx concentrations, compared with controls. The measurement of Glx with 1H-MRS has the potential to identify translational biomarkers of juvenile BD pathophysiology and treatment response.|Baseline and 6 weeks||||Brain GLX/Cr||Standard Deviation|Mean
1349604|NCT01805323|Secondary|Peak Mean Change From Baseline in Central Retinal Thickness (CRT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.|Baseline, 2 to 26 weeks following last injection (up to 6.5 months)|All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks.|||microns (μm)|Participants|Standard Error|Mean
1349605|NCT01805323|Primary|Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.|Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)|All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.|||Lines|Participants|Standard Error|Mean
1349606|NCT01805297|Secondary|Changes in Mean Central Retinal Thickness.|The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.|24 weeks|Due to lack of clear view due to vitreous Hemorrhage, all but 2 patients were unable to have optical coherence tomography at baseline, and one these was lost to follow up. For this reason, data collected for the few patients who were able to have the test was not analyzed|||Microns|||Number
1349607|NCT01805297|Secondary|Need for Any Additional Surgical Intervention.||24 weeks||||Participants|||Count of Participants
1349608|NCT01805297|Secondary|Mean Change in Visual Acuity|"Change in visual acuity measured using Early Treatment of Diabetic Retinopathy Study visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased."|24 weeks|Patients who completed 24 week visit|||Number of letters Read||Full Range|Mean
1349609|NCT01805297|Primary|Rate of Resolved Post-operative Vitreous Hemorrhage.|Percentage of patients who had no vitreous hemorrhage before or at week 24|24 weeks||||Participants|||Count of Participants
1349610|NCT01805180|Secondary|Safety|"Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs).~any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA."|48-hours after last procedure||||events|||Number
1349611|NCT01805180|Secondary|Usability/Assessment of System Operation - Device Malfunctions||Result know immediately upon successful completion of procedure||||events|||Number
1349612|NCT01805180|Secondary|Usability/Assessment of System Operation - Adjustments|Number of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate.|Adjustments known immediately upon completion of the procedure||||number of adjustments||Standard Deviation|Mean
1349613|NCT01805180|Secondary|Usability/Assessment of System Operation - Time|Procedure time for collections on the Spectra Optia vs. the COBE Spectra.|Result captured immediately upon completion of procedure||||minutes||Standard Deviation|Mean
1349614|NCT01805180|Secondary|Characterization of the Blood Product - Volume|Characterization of the collected blood product, specifically product volume.|within 5 minutes after collection procedure||||mL||Standard Deviation|Mean
1349615|NCT01805180|Secondary|Characterization of the Blood Product - RBC Contamination|Characterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product.|within 5 minutes after collection procedure||||RBC percent of product volume||Standard Deviation|Mean
1349616|NCT01805180|Secondary|Characterization of the Blood Product - PMN Cell Viability|Characterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product.|within 5 minutes after collection procedure||||percent of viable cells||Standard Deviation|Mean
1349617|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed|Characterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device.|within 5 minutes after each collection procedure||||cells *10^10 per L of blood processed||Standard Deviation|Mean
1349618|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield|Characterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product.|within 5 minutes after each collection procedure||||cells *10^10||Standard Deviation|Mean
1349619|NCT01805180|Secondary|Performance|Comparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure||||percent of cells processed||Standard Deviation|Mean
1349620|NCT01805180|Primary|Granulocyte/PMN Cell Collection Efficiency|The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure||||percent cells processed||Standard Deviation|Mean
1349621|NCT01805089|Secondary|Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months|Mood was assessed by the Center for Epidemiologic studies Depression Scale. The scale measures depressive symptoms in 20 items. Each question has a 4 point answer (0-3) so the scale range is 0-60. A higher score indicates more depression. Sleep quality was assessed by the Pittsburgh Sleep Quality Index. There are 19 questions each with a 3 point answer. The questions are grouped into 7 subscales and each has a value from 0-3. The 7 subscales are then added together to yield a global score with a range of 0-21. Higher scores indicate worse sleep. Menopausal symptoms were assessed by NCCTG Hot Flash diary. Subjects track the number and severity of hot flashes daily for 1 week. Subjects grade the severity of the hot flashes on a scale of 1-4, with 1 being mild and 4 very severe. Frequency and the severity determine the score . The minimum score is 0 (no hot flashes) and there is no maximum score. A higher score indicates more severe hot flashes. There are no subscales or no units.|baseline and 4 months||||change in PSQI score||Standard Deviation|Mean
1349626|NCT01804946|Secondary|Change in the Patient’s Quality of Life.|The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).|Day 7 vs. Day 1|Per Protocol set|||Scores on a scale||Standard Deviation|Mean
1349627|NCT01804946|Secondary|The Number of the Antipyretic Intake|A subject recorded the number of antipyretic intake in patient diary.|Day 1 to Day 5|Per Protocol set|||Number of Doses||Standard Deviation|Mean
1349628|NCT01804946|Secondary|Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)|The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom’s total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)|on days 1, 3 and 7 of the observation|Per Protocol set|||Scores on a scale||Standard Deviation|Mean
1349629|NCT01804946|Secondary|Mean Body Temperature|The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)|on days 1, 3 and 7 of the observation|Per Protocol set|||°C||Standard Deviation|Mean
1349630|NCT01804946|Secondary|Time to Resolution of the Influenza|"Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms.~The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7."|Day 1 to Day 7|Per Protocol set|||Days||Standard Deviation|Mean
1349631|NCT01804946|Secondary|Percentage of Patients With Resolution of Influenza Symptoms|Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom|on the day 7 of the observation|Per Protocol set.|||Percentage of participants|||Number
1349632|NCT01804946|Primary|Percentage of Patients With Normal Body Temperature|Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)|Day 1 to Day 5|The Per Protocol (PP) set includes subjects received full per protocol therapy, completed all scheduled visits and had no substantial deviations from the protocol. Since PP-analysis and ITT-analysis demonstrated similar (confirmative) results the results of PP-analysis are presented.|||Percentage of participants|||Number
1349633|NCT01804881|Secondary|Change in Weight|Weight was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to be re-weighed.|6 weeks|Intention to Treat analysis|||kg||Standard Deviation|Mean
1349634|NCT01804881|Secondary|Change in Blood Pressure|Blood Pressure was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to have blood pressure taken again.|6 weeks|Intention to Treat analysis|||mm Hg||Standard Deviation|Mean
1349635|NCT01804881|Primary|The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.|"The EEQ is a10-item validated questionnaire measuring the degree of interaction between food intake and emotion. Scores on a scale between baseline score and score after 6 weeks was measured.~The EEQ is scored as follows:~Values: Never = ‘0’; Sometimes = ‘1’; Generally = ‘2’; Always = ‘3’ Score between 0-5: “You are a non-emotional eater. Score between 6-10: “You are a low emotional eater. Score between 11-20: “You are an emotional eater. Score between 21-30: “You are a very emotional eater. The participants completed the EEQ at baseline and it was scored. After 6 weeks the participants completed the EEQ again and it was scored again. The participants' baseline score was compared to the score at week 6. The goal was for scores to reduce. If participants' scores were higher at week 6, that could mean that the intervention was not successful. If the participants' scores were lower at week 6, that could mean that the intervention was successful."|6 weeks|Intention to Treat analysis|||Scores on a scale||Standard Deviation|Mean
1349636|NCT01804842|Primary|Rmax (0-24) of Plasma Glucose|Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||mg/dL||Standard Error|Least Squares Mean
1349637|NCT01804842|Primary|AUC (0-24) of Plasma Glucose|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.|Evaluable Population|||mg*h/dL||Standard Error|Least Squares Mean
1349638|NCT01804842|Primary|Cmax of Plasma Metformin|Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng/mL||Standard Error|Least Squares Mean
1349648|NCT01804673|Secondary|Time to Mobilization|Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.|Baseline, Hours 24, 48 and 72|Data was not statistically summarized but reported in individual participant listing. Due to excessive missing data it was not possible to calculate valid results for the different stages of mobilization.||||||
1349639|NCT01804842|Primary|AUC (0-24) of Plasma Metformin|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng*h/mL||Standard Error|Least Squares Mean
1349640|NCT01804673|Secondary|Post-Operative Phase (PPP33) Quality of Life Questionnaire Score|The PPP33 questionnaire has an overall score and 8 subscales that represent different aspects of the post-operative quality of life: information, autonomy, communication, physical complaints, pain, rest, fear and accommodation. Answers to individual question are scored with values 1 to 4. Summary scores are calculated by adding values for each question. Subscores ranges depend on the number of questions evaluated (2 to 7 questions). The overall score ranges from 1 to 100. Higher scores indicate less pain.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||units on scale||Standard Deviation|Mean
1349641|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Participant Questionnaire Responses|Participants were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: A- Is IONSYS easy to use, B- Were you able to operate the system by yourself after receiving instructions, C- Have you found button yourself, D- Was pressing button easy, E- Have you heard system’s beeps, F- Was IONSYS IM easy to understand, G- Did IM help you to use system, H- Did you have problems falling asleep, I- Could you move easily in bed, J- Did system bother you during physiotherapy, K- Do you perceive use of such system as modern treatment standard.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.|||percent of participants|||Number
1349642|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses|Nursing staff were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: IM A- Was IM easy to understand, B- Did IM help you to use system properly; IONSYS PCA A- Is system easy to handle, B- Did participant need help in using system, C- Do you feel confident using IONSYS; IV PCA- Are you experienced in using IV PCA; IONSYS PCA D- Could participant get mobilized sooner, E- Does participant move more, F- Is participant less afraid of moving, G- Were hospital logistics for IONSYS easier to handle.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.|||percent of participants|||Number
1349643|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Physician Questionnaire Responses|Physicians were asked to evaluate the IM for fentanyl-ITS (IONSYS) by responding to following questions of a questionnaire: Part2 D- Would you use IONSYS again, E- Would you prefer IONSYS to intravenous patient controlled analgesia (IV PCA); Part3 A- Was IM easy to understand, B- Did IM help you to use system properly.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent of participants|||Number
1349644|NCT01804673|Secondary|Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization|Physicians were asked to rate the participant’s ability to undergo physiotherapy or mobilization by responding to following questions of a questionnaire: Part 1 A- Does the surgical procedure performed allow the mobilization of the participant, C- Was the mobilization of the participant limited due to pain, D- Is the participant in a condition to undergo physiotherapy; Part 2 A- Was it possible to mobilize the participant sooner than with other pain therapies, B- Does the participant move more, C- Is the participant less afraid of moving. For Part 1-Question C, ‘Partial’ indicates that mobilization of participant was moderately limited due to pain.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatmentat least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies participants evaluable at specified time point for specified item.|||percent of participants|||Number
1349645|NCT01804673|Secondary|Percentage of Participants With Nursing Staff Global Assessment of Pain|Nursing Staff were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.|||percent of participants||95% Confidence Interval|Number
1349646|NCT01804673|Secondary|Percentage of Participants With Physician Global Assessment of Pain|Physicians were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.|||percent of participants||95% Confidence Interval|Number
1349647|NCT01804673|Secondary|Percentage of Participants With Global Assessment of Pain at Hour 48 and 72|Participants were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||percent of participants||95% Confidence Interval|Number
1349709|NCT01803464|Primary|Bone Structure|Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.|baseline to 6 months||||percent change||Standard Deviation|Mean
1349649|NCT01804673|Secondary|Time Spent Out of the Bed Per Day by the Participant|Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||minutes||Standard Deviation|Mean
1349650|NCT01804673|Secondary|Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72|Nursing staff asked the participants to rate their current pain intensity on 11-point NRS (range 0 to 10, 0= no pain; 10= strongest pain imaginable).|Baseline, Hour 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||units on scale||Standard Deviation|Mean
1349651|NCT01804673|Secondary|Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4|Number of hours per day with average pain intensity less than or equal to 4 was measured on a 11-point Numeric Rating Scale (NRS) (range 0 to 10, 0=no pain; 4=mild pain; 10=strongest pain imaginable). If the participant was sleeping at time of measurement, pain intensity was assumed to be less than or equal to 4.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||hours||Standard Deviation|Mean
1349652|NCT01804673|Primary|Percentage of Participants With Global Assessment of Pain at Hour 24|Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hour 24|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit.|||percent of participants||95% Confidence Interval|Number
1349653|NCT01804257|Other Pre-specified|User Experience|Feedback and suggestions from patients, caregivers, and healthcare providers regarding system metrics and summary presentations of medication-taking, biometrics, and activities of daily living. Feedback includes free text and descriptive statistics summarizing numeric scores collected from a standardized instrument focusing on overall satisfaction with the DHFS and its components.|4 weeks|||||||
1349654|NCT01804257|Other Pre-specified|Usability|Characterize, using summary (descriptive) statistics, the use of the digital health feedback system and its components by patients, caregivers, and healthcare providers. Use captured utilizing numeric scores collected from a standardized instrument, focusing on overall comfort and ease of DHFS use.|4 weeks|||||||
1349655|NCT01804257|Other Pre-specified|Biometrics|Characterize, using summary (descriptive) statistics, heart rate and rest/activity patterns in a free-living environment. Activity defined as the number of hours per day with recorded a recorded step rate ≥ 60 steps per minute|4 weeks|||||||
1349656|NCT01804257|Other Pre-specified|Taking and Scheduling Adherence|Characterize, using summary (descriptive) statistics, medication-taking behavior in free-living environment. Taking adherence defined as the number of ingestion sensors detected by the DHFS in the free-living environment, divided by the prescribed (planned) number of ingestions. Scheduling adherence defined as number of ingestion sensors detected by the DHFS within a ± 2-hour time window around the prescribed (planned) dosing time, divided by the total number of ingestion sensors detected by the DHFS.|4 weeks|||||||
1349657|NCT01804257|Secondary|System Safety|Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study|8 weeks|||||||
1349658|NCT01804257|Primary|Positive Detection Accuracy|Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.|4 weeks|28 individuals with bipolar disorder (12) or schizophrenia (16)|||percentage of observed ingestions||95% Confidence Interval|Mean
1349659|NCT01804140|Primary|Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples|FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.|||participants|||Number
1349660|NCT01804140|Primary|Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type|Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer [μm] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population.|||percentage of participants||95% Confidence Interval|Number
1349661|NCT01804101|Secondary|Overall Remission Rate (CR+CRp)|Overall Remission Rate for the CR/CR with incomplete platelet count recovery (CRp) rate after up to 4 cycles of induction/re-induction therapy.|Up to day 28||||Participants|||Count of Participants
1349662|NCT01804101|Primary|Treatment-related Mortality Rate. (TRM)|Estimate whether the 32 units/m2 or the 64 units/m2 or both dose levels of CPX-351 are likely to improve treatment-related mortality (TRM) rate while keeping the CR rate constant in patients with untreated high-risk MDS or non-APL AML at high risk of TRM.|Up to 1 month after completion of study treatment||||Participants|||Count of Participants
1349663|NCT01804075|Secondary|Second Drug for Withdrawal|Number of infants treated with a second drug to treat their withdrawal|From date of randomization until the date of last opioid dose or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months||||Participants|||Count of Participants
1349664|NCT01804075|Primary|Days of Treatment With Opioid Medication|The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs|From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months||||days||Standard Deviation|Mean
1349665|NCT01804062|Secondary|ME +/- 1 Breath Per Minute, Max-N Sensor|The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continuous monitoring||||BrPM||Standard Deviation|Mean
1349666|NCT01804062|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continous monitoring||||BrPM||Standard Deviation|Mean
1349667|NCT01804036|Secondary|Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)|This is a validated questionnaire which tracks how facets of mindfulness may develop over time. It has 39 items and divides into 5 factors representing the various aspects of mindfulness. The range is 0-195. The greater the value the greater an individual's mindfulness level.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
1349668|NCT01804036|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items. All items are summed to obtain a CD-RISC total score ranging from 0–100, with greater total scores indicating greater resilience.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
1349669|NCT01804036|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is one of the most commonly validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week. Each item is summed to obtain a CES-D total score ranging from 0 to 60; higher scores indicate more severe depressive symptoms. A total score of 16 or higher was identified in early studies as indicative of individuals with depressive illness.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
1349670|NCT01804036|Secondary|PTSD Check List (PCL) - Military (PCL-M)|The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on DSM criteria (DSM-IV criteria for this version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.Range is 0-85, the greater the value the worse the PTSD reported symptoms.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
1349671|NCT01804036|Primary|Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 2-month follow-up.|Baseline, 2 month follow up||||minutes||95% Confidence Interval|Mean
1349672|NCT01804036|Primary|Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 1-week follow-up.|Baseline, 1-week follow up||||minutes||95% Confidence Interval|Mean
1349673|NCT01804036|Primary|Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 2-month follow-up.|Baseline, 2 month follow up||||minutes||95% Confidence Interval|Mean
1349674|NCT01804036|Primary|Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 1-week follow-up.|Baseline, 1-week follow up||||minutes||95% Confidence Interval|Mean
1349675|NCT01804036|Primary|Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.|Baseline, 2 month follow up||||minutes||95% Confidence Interval|Mean
1349676|NCT01804036|Primary|Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection. Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.|Baseline, 1-week follow up||||minutes||95% Confidence Interval|Mean
1349677|NCT01804036|Primary|Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up|Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
1349710|NCT01802775|Secondary|Number of Participants With Amputations|Number of participants with amputations within 6 months|within 6 months|Safety Analysis Set|||Participants|||Count of Participants
1349678|NCT01804036|Primary|Change in Insomnia Severity Index, From Baseline at 1-week Follow-up|Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.|Baseline, 1-week follow up||||units on a scale||95% Confidence Interval|Mean
1349679|NCT01804036|Primary|Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up|Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
1349680|NCT01804036|Primary|Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up|Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.|Baseline, 1-week follow up||||units on a scale||95% Confidence Interval|Mean
1349681|NCT01803737|Secondary|Autonomous and Controlled Motivation|At week 12, participants completed the 13-item TSRQ to assess motivation to continue to participate in the program if given the opportunity. The TSRQ represents participants’ reasons for continuing participation in a weight loss program via participants’ endorsement of statements of autonomous and controlled motivation. Responses were given using a 7-point Likert scale (1 = not at all true to 7 = very true). The responses on the autonomous items (5) and controlled items (8) were averaged.|Week 12||||units on a scale||Standard Deviation|Mean
1349682|NCT01803737|Secondary|Change in Weight Loss Self-efficacy|Self-efficacy for weight loss was assessed at week 0 and 12 using a 20-item Weight Efficacy Lifestyle Questionnaire (WEL). The total score ranges from 0-180. Higher values represent greater beliefs toward the completion of weight management behaviors.|Week 0 and 12||||units on a scale||Standard Deviation|Mean
1349683|NCT01803737|Secondary|Completion of Self-monitoring of Dietary Intake and Physical Activity|The frequency that participants engaged in the self-monitoring of dietary intake and physical activity was assessed at week 12. The diaries were completed weekly throughout the study.|Week 0 and 12||||percentage of diaries completed|Participants|Standard Deviation|Mean
1349684|NCT01803737|Secondary|Change in Dietary Intake: % Carbohydrate|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||percentage of carbohydrate intake||Standard Deviation|Mean
1349685|NCT01803737|Secondary|Change in Dietary Intake: % Protein|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||percentage of protein intake||Standard Deviation|Mean
1349686|NCT01803737|Secondary|Change in Dietary Intake: % Fat|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||percentage of fat intake||Standard Deviation|Mean
1349687|NCT01803737|Secondary|Change in Dietary Intake: Kcals/Day|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||kcals/day||Standard Deviation|Mean
1349688|NCT01803737|Secondary|Change in Physical Activity|A questionnaire will be used to measure and quantify energy expenditure from physical activity.|Week 0 and 12||||kcals/wk||Standard Deviation|Mean
1349689|NCT01803737|Primary|Change in Body Weight|Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.|Week 0 and 12||||kg||Standard Deviation|Mean
1349690|NCT01803711|Secondary|Leeds Sleep Evaluation Questionnaire (LSEQ)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
1349691|NCT01803711|Secondary|Visual Analog Scale for Pain (VAS-P)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
1349692|NCT01803711|Secondary|Visual Analog Scale for Energy (VAS-E)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
1349693|NCT01803711|Secondary|Short Form Health Survey (SF-12)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
1349694|NCT01803711|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
1349695|NCT01803711|Primary|Hospital Anxiety and Depression Scale|Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.|12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
1349696|NCT01803646|Primary|Safety: Frequency of Subjects With Deterioration of Hearing at Follow up Visit 2 (FUV2)|"Occurence of deterioration of hearing (Air and Bone conduction) in the treated ear at FUV2.~Deterioration is defined as a deterioration of hearing threshold of at least 15 dB from Baseline at the average of 2 contiguous frequencies."|Day 35|Valid for Safety dataset was used. Of the 336 valid for safety subjects, 323 could be evaluated for this endpoint.|||Participants|||Count of Participants
1349711|NCT01802775|Secondary|Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period|Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death|within 6 months|mITT Set 1 (Safety Analysis Set), defined as the participants who received at least 1 dose of study drug|||Participants|||Count of Participants
1349697|NCT01803646|Primary|Co-Primary Efficacy: Improvement in Tinnitus Functional Index (TFI) Total Score From Baseline to FUV3|"The TFI was recorded on an electronic device (electronic patient reported outcome) at Treatment Visit 1 (TV1), before randomization, and at Follow up Visit 1 (FUV1), FUV2 and FUV3.~The TFI is a patient reported outcome questionnaire and contains 25 questions. It includes eight subscales: Intrusive, Sense of Control, Cognitive, Sleep, Auditory, Relaxation, Quality of Life, and Emotional. Each question is to be rated on a NRS between 0 and 10 (or 0 to 100%), with a recall period of “over the past week”.~The TFI total score is considered as valid if there are evaluable answers for at least 19 of the 25 items (76% of items) (Meikle et al. 2012). The repondent's overall TFI score is within a 0-100 range. For the subscales the range is the same. A lower value represents an improvement for all scales.~Please refer to the following publicly available link for more information: http://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/EANDH/A/EANDH_2011_09_27_HENRY_200593_SDC15.pdf"|D0 (=TV1) versus Day 84 (=FUV3)|"Valid for Efficacy dataset includes all subjects treated with at least one i.t. injection (AM-101 or placebo), a valid TLQ NRSLoudest or TFI rating at baseline and at least one valid post-baseline rating.~Ten subjects had neither TLQ nor TFI baseline plus additional 25 subjects had no baseline for the TFI resulting in 301 evaluable subjects."|||units on a scale||95% Confidence Interval|Least Squares Mean
1349698|NCT01803646|Primary|Efficacy: Change in Patient-reported Tinnitus Loudness Questionnaire (TLQ) Improvement From Baseline to Follow up Visit 3 (FUV3)|"Starting at the screening visit (SV), each subject recorded the following numerical rating scales (NRS) throughout the entire study duration:~- Tinnitus loudness “at its loudest” within the last 24 hours (Tinnitus Loudness Questionnaire [TLQ] NRSLoudest). Subjects were asked “On a scale from 0 to 10, where 0 represents no tinnitus and 10 represents extremely loud tinnitus, what one number best describes your tinnitus at its loudest in the last 24 hours (including right now)?” TLQ NRSLoudest was collected from SV (D-14) to the evening before FUV3 (D83). The ratings were to be recorded every day before going to sleep on an electronic device.~As Baseline the10 ratings of the screening period before the first treatment were averaged. For the FUV3 endpoint, the ratings of the 7 days before FUV3 were averaged."|Screening (D-14) versus final follow-up (D83)|"Valid for Efficacy dataset includes all subjects treated with at least one i.t. injection (AM-101 or placebo), a valid TLQ NRSLoudest or TFI rating at baseline and at least one valid post-baseline rating.~Ten subjects had neither TLQ nor TFI baseline and 2 subjects had no valid rating for the TLQ resulting in 324 evaluable subjects."|||units on a scale||95% Confidence Interval|Least Squares Mean
1349699|NCT01803607|Secondary|Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)|s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results|||Percentage Change from Baseline||Standard Error|Geometric Mean
1349700|NCT01803607|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)|s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results|||Percentage Change from Baseline||Standard Error|Geometric Mean
1349701|NCT01803607|Secondary|Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)|The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.|||Percentage Change from Baseline||Standard Error|Geometric Mean
1349702|NCT01803607|Secondary|Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)|u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.|||Percentage Change from Baseline||Standard Error|Geometric Mean
1349703|NCT01803607|Secondary|Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)|s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.|Baseline and Month 12|The Per Protocol (PP) population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.|||Percent Change from Baseline||Standard Error|Geometric Mean
1349704|NCT01803607|Secondary|Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD|DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.|Baseline and Month 12|The FAS includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements|||Percentage Change from Baseline||Standard Error|Mean
1349705|NCT01803607|Secondary|Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib|DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.|Baseline and Month 24|The trial was terminated prematurely, thus this analysis was not conducted.||||||
1349706|NCT01803607|Primary|Percent Change From Baseline to Month 12 in Femoral BMD|Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.|Baseline and Month 12|The Full Analysis set (FAS) includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements.|||Percent Change from Baseline||Standard Error|Mean
1349707|NCT01803464|Secondary|Bone Mass|Change in bone mineral content in the distal femur from baseline to 6 months, as measured by dual-energy X-ray absorptiometry (DXA)|baseline to 6 months||||percent change||Standard Deviation|Mean
1349708|NCT01803464|Secondary|Muscle Volume|Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI|baseline to 6 months||||percent change||Standard Deviation|Mean
1349712|NCT01802775|Secondary|Safety Assessments|"Number of participants with serious adverse events (SAEs) within 6 months~Note: Based on changes to the database structure, clinically significant changes in physical or laboratory parameters are recorded as adverse events (AEs). Details of non-serious adverse events are reported at the 5% reporting threshold in the AE module, as is all-cause mortality."|within 6 months|Safety Analysis Set|||Participants|||Count of Participants
1349713|NCT01802775|Secondary|Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment|The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months|within 3 months|Safety Analysis Set, defined as all participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
1349714|NCT01802775|Primary|Percentage of Participants With First Re-stenosis / Re-occlusion|Percentage of participants with re-stenosis/re-occlusion during treatment within 6 months - only the first occurrence of re-stenosis / re-occlusion was counted for each participant|within 6 months|Modified Intent-to-Treat (mITT), defined as all randomized subjects who received at least one dose of the study study and had at least one post-dose duplex scanning|||percentage of participants|||Number
1349715|NCT01802775|Primary|Percentage of Participants With Clinically Relevant Bleeding During Treatment|Percentage of participants with clinically relevant bleeding, defined as major bleeding or clinical relevant non-major bleeding, in the on-treatment period based on International Society of Thrombosis and Haemostasis (ISTH)|at 3 months|Safety Analysis Set, defined as all participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
1349716|NCT01802632|Secondary|Best Objective Response (BOR) for 80mg AZD9291 Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by investigator assessment) at baseline.|||% of participants|||Number
1349717|NCT01802632|Primary|Objective Response Rate (ORR) for Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.|||% of participants||95% Confidence Interval|Number
1349718|NCT01802632|Secondary|Progression-Free Survival (PFS) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||months||95% Confidence Interval|Median
1349719|NCT01802632|Secondary|Duration of Response (DoR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||months||95% Confidence Interval|Median
1349731|NCT01802320|Secondary|Overall Survival (OS)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for OS.|Up to 18 months|||||||
1349732|NCT01802320|Secondary|Duration of Tumor Response (DR)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for DR.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 18 months|Outcome data not collected, no analysis to be performed as participants had related tumor response.||||||
1350082|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
1349720|NCT01802632|Primary|Best Objective Response (BOR) for Dose Escalation Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||% of participants|||Number
1349721|NCT01802632|Primary|Objective Response Rate (ORR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||% of participants||95% Confidence Interval|Number
1349722|NCT01802554|Secondary|Positive and Negative Affect Schedule|This scales contains ten items assessing Negative Affect. Items included are adjectives, such as “distressed,” “ashamed,” and Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Lower scores represent better outcomes.|Change from Baseline Negative Affect at 8-weeks||||units on a scale||Standard Error|Mean
1349723|NCT01802554|Secondary|Positive and Negative Affect Schedule|This scales contains ten items assessing Positive Affect. Items included are adjectives, such as “interested,” “strong,” and “inspired”. Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Higher scores represent better outcomes.|Change from Baseline Positive Affect at 8-weeks||||units on a scale||Standard Error|Mean
1349724|NCT01802554|Primary|Interleukin-6 (IL-6)|IL-6 is one of many biomarkers represented in the inflammatory cascade which is initiated during an immune response. Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men and increasing concentrations of IL-6 have been associated with both nonfatal myocardial infarction and fatal Coronary Heart Disease (CHD) in longitudinal studies of population-based cohorts. Higher concentrations of IL-6 raise CHD risk. Blood was collected by a research nurse in the caregivers’ homes through a 22-gauge forearm catheter after a 20 min rest. Blood for IL-6 was dispensed in Ethylenediaminetetraacetic acid (EDTA) tubes and spun at 3000 g for 10 minutes at 4 to 8 degrees Celsius. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma IL-6 (Meso Scale Discovery, Gaithersburg, MD) was determined via highsensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline IL-6 at 8-weeks||||pg/ml||Standard Error|Mean
1349725|NCT01802554|Primary|D-dimer|D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. High concentrations of D-dimer have been linked prospectively to onset of Coronary Heart Disease. Blood was collected by a research nurse in the caregivers’ homes through a 22 gauge forearm catheter after a 20 minute rest. Blood for D-dimer was dispensed into polypropylene tubes with 3.8 percent sodium citrate and spun at 1600 g for 10 minutes at room temperature. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma D-dimer (Asserachrom Stago, Asnieres, France) was determined via high sensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline D-dimer at 8-weeks||||ng/ml||Standard Error|Mean
1349726|NCT01802554|Primary|Brief Center for Epidemiologic Studies Depression Scale (CESD)|The Brief CESD is a measure of depressive symptoms. The scale's minimum score is 0 and maximum score is 30. Lower scores represent fewer depressive symptoms and thus better outcomes.|Change from Baseline CESD at 8-weeks||||units on a scale||Standard Error|Mean
1349727|NCT01802515|Secondary|Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale|Center for Epidemiological Studies-Depression. The CES-D is a 20-item self-report measure of depressive symptoms. Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60. Larger values represent more severe symptoms. It is a validated instrument with a score of 16 or more indicating clinically significant depression. The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study).|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.|||units on a scale||Standard Deviation|Mean
1349728|NCT01802515|Primary|Treatment Retention|The number of participants completing all 8 weeks of treatment phase.|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.|||participants|||Number
1349729|NCT01802320|Secondary|Validation of the Enrichment Biomarker Signature in Metastatic Sites|Samples will be analyzed using the Wilcoxon rank test. Chi-square or Fisher’s exact test where appropriate will be used to determine whether high levels of marker expression correlate with PTEN status.|Up to 18 months|||||||
1349730|NCT01802320|Secondary|Progression-free Survival (PFS)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for PFS.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 18 months|||||||
1350114|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 16 to 19 months post-vaccination|||||||
1349733|NCT01802320|Primary|Overall Response Rate (CR+PR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response (PR): > 30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): > 20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of >5 mm. (Note: appearance of 1/> new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.|Up to 18 months||||Participants|||Count of Participants
1349734|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires|Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).|Weeks 1, 5, and 6|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349735|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||Hours||Standard Error|Mean
1349736|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349737|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349738|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349739|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349740|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349741|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349742|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349743|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349744|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349852|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Mortality|Individual component of the primary endpoint of mortality at 180 days after randomization|Randomization to 180 days|All randomized subjects.|||participants|||Number
1349745|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349746|NCT01802151|Secondary|Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)|Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).|6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||log CFU/g||Standard Error|Mean
1349747|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
1349748|NCT01801982|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Month 12|FAS included all enrolled participants.|||participants|||Number
1349749|NCT01801982|Secondary|Overall Survival at Month 24|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).||||||
1349750|NCT01801982|Secondary|Overall Survival at Month 12|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported.|Month 12|Full Analysis Set (FAS) included all enrolled participants.|||participants|||Number
1349751|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 24|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).||||||
1349752|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 12|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 12|Full Analysis Set (FAS) included all enrolled participants.|||participants|||Number
1349753|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 24|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).||||||
1349754|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 12|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 12|Full Analysis Set (FAS) included all enrolled participants.|||participants|||Number
1349755|NCT01801917|Secondary|BAF312 Trough Plasma Concentrations (PK Set)|All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For each sample, approximately 2 mL of blood was drawn. BAF312 was determined in ethylenediaminetetraacetic acid (EDTA) plasma using a validated liquid chromatography–tandem mass spectrometry (LC-MS/MS) bioanalytical method for the quantification. The anticipated lower limit of quantification (LLOQ) was 0.02 ng/mL using 0.1 mL of plasma|-7 Baseline, day 28, 56, 84|P|||ng/mL||Standard Deviation|Mean
1349756|NCT01801917|Secondary|Six-minute Walking Distance (6MWD) at Week 24|This test assessed the distance a patient could walk in 6 minutes (Rutkove et al 2002). If the patient was not able to walk for 6 minutes then a 2 minute walking test was conducted|Baseline, 24 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||meters||Standard Deviation|Mean
1349757|NCT01801917|Secondary|Six-minute Walking Distance (6MWD) at Week 12|This test assessed the distance a patient could walk in 6 minutes (Rutkove et al 2002). If the patient was not able to walk for 6 minutes then a 2 minute walking test was conducted|Baseline, 12 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||meters||Standard Deviation|Mean
1349758|NCT01801917|Primary|Percent Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) Serum Creatine Kinase (CK) Levels|Serum creatine kinase (CK) were analyzed as part of the blood chemistry panel. Posterior credibility interval from Bayesian analysis displayed as confidence interval. The variable CK was log-transformed for statistical analysis and after estimation was converted to percent change from baseline divided by the mean baseline|Baseline, at 12 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||U/L||90% Confidence Interval|Mean
1349863|NCT01800968|Secondary|Change in Medial Filling Pressure|Change in medial filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.|||m/sec||Standard Deviation|Mean
1349864|NCT01800968|Secondary|Change in Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline to day 180|Baseline to 180 days|All randomized subjects.|||percent||Standard Deviation|Mean
1349759|NCT01801917|Primary|Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) for Combined Efficacy Endpoint: Manual Muscle Testing in 24 Muscles (MMT24)|Manual Muscle Testing Scoring Sheet: Neck flexors, neck extensors and other designated muscles bilaterally (Biceps brachii, Deltoid middle, Quadriceps, Gluteus maximus, Gluteus medius, Trapezius, Iliopsoas, Hamstrings, Wrist extensors, Wrist Flexors, Ankle plantar flexors and Ankle dorsiflexors) were tested on a 0-10 scale by the Investigator. Posterior credibility interval from Bayesian analysis displayed as confidence interval. The scores range was 0 to 260. Higher scores indicate better outcome.|Baseline, at 12 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||scores on a scale||90% Confidence Interval|Mean
1349760|NCT01801735|Primary|Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.|Baseline to Week 52/Early Termination||||participants|||Number
1349761|NCT01801475|Primary|Metabolic Clearance of Ondasetron|This is a mathematical estimation of the clearance for ondasetron as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All patient data was used in the estimation process.|||L/hr||95% Confidence Interval|Mean
1349762|NCT01801475|Primary|Volume of Distribution Estimated Pharmacokinetic Parameter|This is an estimated pharmacokinetic parameter as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All subjects but not possible for neonates|||Liters||95% Confidence Interval|Mean
1349763|NCT01801449|Primary|Number of Subjects Who Maintained Inflammatory Remission With Rilonacept|Inflammatory remission criteria remission criteria were defined as meeting all of the following criteria: a diary score of <0.5 (reflecting no fever, skin rash or bone pain), normal acute phase reactants (C-reactive protein (CRP) <0.5 mg/dL), no objective skin rash or radiological evidence of active bone lesions on x-ray.|6 months|Analysis included all subjects|||Participants|||Count of Participants
1349764|NCT01801449|Secondary|Pediatric Quality of Life Inventory (PedsQL)|Pediatric Quality of Life Inventory (PedsQL)-assess functional impairment and change in treatment and health-related quality of life respectively. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|Baseline|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
1349765|NCT01801449|Secondary|Pediatric Quality of Life Inventory (PedsQL)|Pediatric Quality of Life Inventory (PedsQL)-assess functional impairment and change in treatment and health-related quality of life respectively. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|24 months after rilonacept initiation|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
1349766|NCT01801449|Secondary|Dual-energy X-ray Absorptiometry (DEXA) Scores|Mean z-scores of anteroposterior lumbar (AP) spine were used for comparisons|Baseline|Analysis included all subjects|||z-score||Standard Deviation|Mean
1349767|NCT01801449|Secondary|Dual-energy X-ray Absorptiometry (DEXA) Scores|Mean z-scores of anteroposterior lumbar (AP) spine were used for comparisons|12 months after rilonacept initiation|Analysis included all subjects|||z-score||Standard Deviation|Mean
1349768|NCT01801449|Secondary|Childhood Health Assessment Questionnaire (CHAQ)|The Childhood Health Assessment Questionnaire (CHAQ) is a patient self-assessment (or parent assessment) tool for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). The scores are summed and divided by the number of total categories answered to arrive at a final value.|Baseline|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
1349769|NCT01801449|Secondary|Childhood Health Assessment Questionnaire (CHAQ)|The Childhood Health Assessment Questionnaire (CHAQ) is a patient self-assessment (or parent assessment) tool for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). The scores are summed and divided by the number of total categories answered to arrive at a final value.|24 months after rilonacept initiation|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
1349770|NCT01801449|Secondary|Weight|Antropometric measurements - Weight z-score|Baseline|Analysis included all subjects|||z-score||Standard Deviation|Mean
1349771|NCT01801449|Secondary|Weight|Antropometric measurements - Weight z-score|24 months after rilonacept initiation|Analysis included all subjects|||z-score||Standard Deviation|Mean
1349772|NCT01801449|Secondary|Height|Antropometric measurements - Height z-score|Baseline|Analysis included all subjects|||z-score||Standard Deviation|Mean
1349773|NCT01801449|Secondary|Height|Antropometric measurements - Height z-score|24 months after rilonacept initiation|Analysis included all subjects|||z-score||Standard Deviation|Mean
1349774|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 11 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter||Standard Deviation|Mean
1349865|NCT01800968|Secondary|Change in Left Ventricular End-systolic Volume Index|Change in left ventricular end-systolic volume index from baseline to day 180.|Baseline to 180 days|All randomized subjects.|||ml per meter squared||Standard Deviation|Mean
1350115|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 16 to 19 months post-vaccination|||||||
1349775|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 1 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter||Standard Deviation|Mean
1349776|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 11 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter per Hour||Standard Deviation|Mean
1349777|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 1 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter per Hour||Standard Deviation|Mean
1349778|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 11 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour||Standard Deviation|Mean
1349779|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 1 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour||Standard Deviation|Mean
1349780|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 11 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn – tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour square*ng per ml||Standard Deviation|Mean
1349781|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 1 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn – tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour square*ng per ml||Standard Deviation|Mean
1349782|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per ml||Standard Deviation|Mean
1349783|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per ml||Standard Deviation|Mean
1349866|NCT01800968|Secondary|Change in Left Ventricular End-Diastolic Volume Index|Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.|Baseline to 180 days|All randomized subjects.|||ml per meter squared||Standard Deviation|Mean
1350116|NCT01797029|Secondary|The Viral Etiologies of Acute Respiratory and Febrile Illness||Through 16 to 19 months post-vaccination|||||||
1349784|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per mL||Standard Deviation|Mean
1349785|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per ml||Standard Deviation|Mean
1349786|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 11 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Per Hour||Standard Deviation|Mean
1349787|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 1 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Per Hour||Standard Deviation|Mean
1349788|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 11 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
1349789|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 1 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
1349790|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 11 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
1349791|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 1 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
1349792|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 11 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||ng per ml||Standard Deviation|Mean
1349793|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 1 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The Per-protocol (PP) population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Nanogram per millileter (ng per ml)||Standard Deviation|Mean
1349794|NCT01801436|Primary|Number of Participants With KPS Score at Day 11 of Cycle 8|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
1349884|NCT01800162|Secondary|Quantification of Re-interventions Needed to Manage a Woman With a PPUL|"Outcomes include:~number of interventions beyond that of intended initial strategy in each group~additional number of MTX injections~additional surgical procedures~uterine evacuation (or dilation and curettage)~laparoscopy~laparotomy"|6 weeks|||||||
1349795|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 7|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
1349796|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 5|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 5|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
1349797|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 3|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 3|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
1349798|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 1|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 1|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
1349799|NCT01801436|Primary|Number of Participants With Karnofsky Performance Status (KPS) Score at Baseline|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Baseline|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
1349800|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 11 of Cycle 8|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
1349801|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 7|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
1349802|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 5|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 5|The full analysis set (FAS) population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
1349803|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
1349804|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349805|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349806|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
1349807|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349808|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349809|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
1349810|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349811|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349812|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
1349813|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349814|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
1349885|NCT01800162|Secondary|Number of Ruptured Ectopic Pregnancies in Each Group|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|Outcome will be assess within 6 weeks of randomization|||||||
1350117|NCT01797029|Secondary|The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens||Through 16 to 19 months post-vaccination|||||||
1349815|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
1349816|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
1349817|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
1349818|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as ‘Objective response rate’ in some protocols or publications.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
1349819|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||weeks||Inter-Quartile Range|Median
1349820|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
1349821|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||participants|||Number
1349822|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)|"Serious adverse event (SAE) is defined as one of the following:~Is fatal or life-threatening~Results in persistent or significant disability/incapacity~Constitutes a congenital anomaly/birth defect~Is medically significant~Requires inpatient hospitalization or prolongation of existing hospitalization~Note that hospitalizations for the following reasons should not be reported as serious adverse events:~Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition~Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent~Social reasons and respite care in the absence of any deterioration in the patient’s general condition"|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.|||participants|||Number
1349823|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)|An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient’s signed informed consent has been obtained.|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.|||participants|||Number
1349824|NCT01801358|Primary|Phase II: Progression Free Survival (PFS)|"The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.~Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|||||||
1349825|NCT01801358|Primary|Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle|A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.|Cycle 1 (up to 28 days)|Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.|||DLTs|||Number
1349826|NCT01801280|Primary|Dose-normalized AUC of Mycophenolic Acid|"Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN~For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake."|Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours||||mg*h/L||Standard Deviation|Mean
1349827|NCT01801124|Secondary|The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30.|Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.|30 days|The analysis population comprised all enrolled subjects.|||participants|||Number
1349828|NCT01801124|Primary|The Effectiveness of Abdominal Analgesia From the Infiltration Into the TAP as Measured by the Subject's Overall Postsurgical Analgesic Use|The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)|10 days|The analysis population comprised all enrolled subjects.|||mg (morphine equivalents)||Standard Deviation|Mean
1349829|NCT01801111|Secondary|Percentage of Participants With CNS Progression As Assessed by IRC Based on RECIST|CNS progression was defined as the percentage of participants who developed a new CNS lesion or have disease progression in pre-existing CNS lesions based on IRC review of radiographs by RECIST version 1.1. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at lease 5 mm, progression of existing non-target lesions, or presence of new lesion|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population|||percentage of participants|||Number
1349830|NCT01801111|Secondary|Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RANO|Duration of response in participants with CNS response was defined as the time from the first observation of a CNS response (CR or PR) until first observation of CNS progression or death from any cause based on IRC review of radiographs by RANO criteria. CR and PR were as defined in outcome 39. Progression was defined by any of the following: at least 25% increase in sum of products of diameters of measurable enhancing (measurable) lesions compared to best response after initiation of therapy (nadir), or screening if screening was nadir value on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR non-enhancing lesions not caused by co-morbid events on stable or increasing doses of corticosteroids; Any new lesions; Clear progression of enhancing non-measurable disease. Clinical deterioration not attributable to other non-tumour causes. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline who achieved a CNS response of CR or PR according to IRC.|||months||95% Confidence Interval|Median
1349831|NCT01801111|Secondary|Duration of Response in Participants With CNS Response (CR or PR) as Assessed by IRC Based on RECIST|Duration of response in participants with CNS response was defined as the time from the first observation of a CNS response (CR or PR) until first observation of CNS progression or death from any cause based on IRC review of radiographs by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the screening sum diameters) and no progression of target lesions. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at lease 5 mm, progression of existing non-target lesions, or presence of new lesion. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline and who achieved a CNS response of CR or PR according to IRC.|||months||95% Confidence Interval|Median
1349832|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on Radiology Assessment in Neuro-Oncology (RANO) Criteria|Objective response (CR and PR) of CNS lesions was assessed based on IRC review of radiographs by RANO criteria. CR was achieved if all of the following criteria met: Complete disappearance of all enhancing measurable and non-measurable disease; Stable or improved non-enhancing (T2/FLAIR) lesions; No new lesions; Participant must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. PR was achieved if all of the following criteria met: at least 50% decrease compared with screening in the sum of the products of the diameters (SPD) of measurable enhancing measurable lesions; No progression of non-measurable disease (enhancing and non-enhancing [T2/FLAIR] lesions); No new lesions; Participant must be off corticosteroids (or on physiologic replacement doses only), and clinically stable or improved. For both CR and PR, responses had to be sustained for at least 4 weeks.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants with measurable CNS lesions at baseline according to IRC.|||percentage of participants||95% Confidence Interval|Number
1349833|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) of Baseline Central Nervous System (CNS) Lesions As Assessed by IRC Based on RECIST|Objective response (CR and PR) of CNS lesions was assessed based on IRC review of radiographs by RECIST version 1.1 in participants with measurable CNS lesions at baseline. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the screening sum diameters) and no progression of target lesions.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|Safety population. Number of participants analyzed=participants measurable CNS lesions at baseline according to IRC.|||percentage of participants||95% Confidence Interval|Number
1349834|NCT01801111|Secondary|Percentage of Participants Achieving CR, PR or Stable Disease (SD, Lasting ≥16 Weeks) in Response Evaluable Population|Disease control (CR,PR or SD) was measured by RECIST version 1.1. by IRC and Investigator. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size is <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.|Baseline; every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reasons deemed by the investigator, or data cutoff (18 August 2014, maximum follow up 53 weeks)|RE population. Here, 'n' signifies participants with measurable disease at baseline for specified category.|||percentage of participants||95% Confidence Interval|Number
1349835|NCT01801111|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline up to death (any cause) or data cutoff (18 August 2014, maximum follow up 53 weeks)|Safety population|||months||95% Confidence Interval|Median
1349836|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants|Objective response was assessed by IRC according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC). Number of participants analyzed=participants from RE population (IRC) who received prior chemotherapy.|||percentage of participants||95% Confidence Interval|Number
1349837|NCT01801111|Secondary|Percentage of Participants Who Died||Baseline up to death (any cause) or data cut off (18 August 2014, maximum follow up 53 weeks)|Safety population|||percentage of participants|||Number
1349838|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population|Objective response was assessed by IRC according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC): all participants with measurable disease at baseline according to the IRC, who had baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
1349839|NCT01801111|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 10 Hour Post-dose (AUC[0-10]) of Alectinib||Day 1 and Day 21 of Cycle 1|Data for this endpoint was not collected, as planned, because Part I of this study was not conducted.||||||
1349840|NCT01801111|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Progression (according to RECIST version 1.1) was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion. Progression was assessed by IRC and by the investigator in safety population as well as in subgroups of participants who received prior chemotherapy and who did not receive prior chemotherapy. PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|"Safety population. Here, n signifies the number of participants evaluable for specified category."|||months||95% Confidence Interval|Median
1349841|NCT01801111|Secondary|Percentage of Participants With Progression or Death|Progression (according to RECIST version 1.1) was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion. Progression was assessed by IRC and by the investigator in safety population as well as in subgroups of participants who received prior chemotherapy and who did not received prior chemotherapy.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|"Safety population. Here, n signifies the number of participants evaluable for specified category."|||percentage of participants|||Number
1350118|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 7 to 9 months post-vaccination|||||||
1349842|NCT01801111|Secondary|Duration of Response|Duration of response was defined as the time from the first observation of an objective tumor response until first observation of disease progression using RECIST version 1.1 or death from any cause. Duration of response was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley. Duration of response was assessed by IRC and by investigator as well as in subgroups of participants who received prior chemotherapy and who did not received prior chemotherapy.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population: participants with measurable disease at baseline, had baseline tumor assessment and received at least one dose of alectinib. Number of participants analyzed= participants with measurable disease at baseline and had objective response. n=participants with measurable disease at baseline and had objective response for specified category|||months||95% Confidence Interval|Median
1349843|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Naive Participants|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (investigator). Number of participants analyzed=participants from RE population (investigator) who did not receive prior chemotherapy.|||percentage of participants||95% Confidence Interval|Number
1349844|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Pretreated Participants|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (investigator). Number of participants analyzed=participants from RE population (investigator) who received prior chemotherapy.|||percentage of participants||95% Confidence Interval|Number
1349845|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Response Evaluable Population|Objective response was assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (Investigator): all participants with measurable disease at baseline according to the investigator, who had baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
1349846|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Naive Participants|Objective response was assessed by IRC according to RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). CR and PR was to be confirmed by repeat assessments ≥4 weeks after initial documentation.|Baseline; assessments every 8 week post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up; data until cutoff (18 August 2014) are reported, maximum 53 weeks|RE population (IRC). Number of participants analyzed=participants from RE population (IRC) who did not receive prior chemotherapy.|||percentage of participants||95% Confidence Interval|Number
1349847|NCT01801111|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|DLTs were to be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.3. DLTs: drug-related toxicities that meet any one of the following criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia continuing for ≥7 consecutive days or neutropenic fever; Non-hematological toxicity of Grade 3 or higher; Adverse events that require interruption of treatment for a total of ≥7 days.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).||||||
1349848|NCT01801111|Primary|Recommended Phase II Dose of Alectinib|RP2D was to be determined based on the safety and tolerability profile of the study treatment.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).||||||
1349849|NCT01800968|Secondary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.|Baseline to 180 days|All randomized subjects.|||rank||Standard Deviation|Mean
1349850|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP|Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days|Baseline to 180 days|All randomized subjects.|||weighted average of ratio to baseline||Standard Deviation|Mean
1349851|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Heart Failure Hospitalization|Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days|Randomization to 180 days|All randomized subjects.|||participants|||Number
1349853|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 180 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
1349854|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
1349855|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
1349856|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to day 180|All randomized subjects.|||units on a scale||Standard Deviation|Mean
1349857|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
1349858|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
1349859|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 180 days.|Baseline to 180 days|All randomized subjects.|||meters||Standard Deviation|Mean
1349860|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 90 days.|Baseline to 90 days|All randomized subjects.|||meters||Standard Deviation|Mean
1349861|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to day 30|Baseline to day 30|All randomized subjects.|||meters||Standard Deviation|Mean
1349862|NCT01800968|Secondary|Change in Lateral Filling Pressure|Change in lateral filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.|||m/sec||Standard Deviation|Mean
1349867|NCT01800968|Primary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.|Randomization to 180 days|All randomized subjects.|||rank||Standard Deviation|Mean
1349868|NCT01800916|Primary|Degree of Leakage|"The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.~The subjects had to tick off one of the following choices:~No leakage~Starting to leak~Leakage~Sudden Leakage"|one week|The subjects were randomized to one of nine possible treatment groups. Each group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for. The ITT population was used for the analysis.|||percentage of baseplates with no leakage|baseplates||Number
1349869|NCT01800903|Primary|Overall Discomfort During Catheterization|Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.|1 day||||cm||Standard Deviation|Mean
1349870|NCT01800890|Primary|Degree of Leakage|"The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S.~The 4-point leakage scale has four choices~No leakage~Starting to leakage~Leakage~Sudden leakage~Leakage was assessed at every baseplate change"|10 days||||units on a scale|Participants|Standard Deviation|Mean
1349871|NCT01800786|Primary|Overnight Change in Declarative Memory Performance|"At 3 months, we compared average overnight changes between evening and morning performance on a declarative memory test between untreated OSA subjects and those who received CPAP therapy for 3 months.~Positive numbers represent an increase in performance."|3 months||||percent change in performance||Standard Deviation|Mean
1349872|NCT01800318|Secondary|Duration of Crying During Heel Stick|Any crying during the heel stick procedure was timed in seconds.|5 minutes +/- 2 minutes|Newborn infants during heel stick procedure, crying timed in seconds|||seconds||Standard Deviation|Mean
1349873|NCT01800318|Secondary|Duration of Crying After TENS Unit Was Initiated But Before Heel Stick.|(a) Any crying after initiation of TENS unit was noted. If the PIPP scores increased by 4 points from baseline, the TENS unit would have been turned off and the infant withdrawn from the study (safety outcome).|10 minutes||||seconds||Standard Deviation|Mean
1349874|NCT01800318|Secondary|Change in Heart Rate Variability During Heel Stick|Changes in Heart Rate Variability (HRV) were evaluated using the DL 900 monitor with 3-channel output with 5 leads. Premature infant leads from Braemar, Incorporated, were used with the DL 900 monitor. Leads were applied to the infant's chest before initiation of the TENS unit and the heel stick. The DL300 Holter Monitor will started recording HRV within 10 minutes of TENS unit initiation and the heel stick procedure and continued recording during the procedure and for 2 minutes afterwards.|Baseline, 20 minutes +/- 5 minutes|Newborn infants|||LF/HF ratio||Standard Deviation|Mean
1349875|NCT01800318|Secondary|Change in Salivary Cortisol After Heel Stick|Salivary cortisol was obtained prior to initiation of heelstick procedure, and at 5±0.5 minutes after procedure by gentle insertion in the mouth of a soft applicator (Salimetrics Infant Swab). The samples were stored at -20 degrees, and were analyzed at UAMS.|Baseline and 5±0.5 minutes after heel stick||||ng/ml||Standard Deviation|Mean
1349876|NCT01800318|Primary|Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze.|"The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged.~Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported.~Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain."|Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged..|Analysis of PIPP scores assigned during heelstick procedure in newborn infants|||units on a scale (PIPP score)||Standard Deviation|Mean
1349877|NCT01800162|Secondary|Future Fertility|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
1349878|NCT01800162|Secondary|Acceptability|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
1349879|NCT01800162|Secondary|Patients' Preferences|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
1349880|NCT01800162|Secondary|Time to Resolution|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
1349881|NCT01800162|Secondary|Number of Visits|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
1349882|NCT01800162|Secondary|Number of Procedures (Lab Tests, Ultrasounds)|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
1349883|NCT01800162|Secondary|Treatment Complications and Adverse Events|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|42 days after the last dose of study medication|||||||
1349886|NCT01800162|Primary|Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|Outcome will be assessed within 6 weeks of randomization|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.||||||
1349887|NCT01799993|Other Pre-specified|Number of Death Due to Any Reason Through Day 10 and Day 15|Number of deaths due to any reason through Day 10 and Day 15 were summarized for each treatment group.|Up to 10 days and 15 days after start of study treatment, respectively|mITT population|||Participants|||Count of Participants
1349888|NCT01799993|Other Pre-specified|Number of Participants With Organ Failure|The overall number of participants with any organ failure was summarized for each treatment group. Organ failure was defined by a specific organ type and by a collection of MedDRA version 20.0 preferred terms that were determined by the sponsor’s clinical team. A participant with multiple AEs within a system organ class or preferred term is counted a single time for that system organ class (SOC) or preferred term.|Up to 7 days after the end of study treatment|ITT for Safety population|||Participants|||Count of Participants
1349889|NCT01799993|Other Pre-specified|Number of Participants Who Received at Least One Dose of Study Drug and Reported a Serious Adverse Event|AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: AE resulting in following outcomes or deemed significant for any reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent; significant disability/incapacity; congenital anomaly/birth defect; medical important serious event judged by investigator. SAEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent SAEs (TESAEs).|Up to 7 days after the end of study treatment|ITT for Safety population|||Participants|||Count of Participants
1349890|NCT01799993|Other Pre-specified|Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event|AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent AEs (TEAEs).|Up to 7 days after the end of study treatment|ITT for Safety population (included all participants in ITT analysis set who were analyzed as treated for safety analyses)|||Participants|||Count of Participants
1349891|NCT01799993|Other Pre-specified|Number of Participants With Emergence of Resistance Among Pathogens|Resistance to amikacin was determined for the bacterial isolates by using a standardized microbiology laboratory test that generates a minimum inhibitory concentration (MIC) for amikacin and bacterial isolate. The same microbiology resistance standard was used for all bacteria tested against amikacin. Resistant bacteria have a MIC value of 64 μg/mL or greater. Percentages of resistance were calculated based on the percentage of participants infected with any treatment-emergent pathogens resistant to amikacin. If a participant had a more than one occurrence of a specific pathogen during pre-treatment period, the worst case of testing was used.|Up to 28-32 days after start of study treatment|mITT population participants with pathogen susceptible to amikacin in pre-treatment period|||Participants|||Count of Participants
1349892|NCT01799993|Other Pre-specified|Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period|New pathogens also denoted as superinfection was defined as the isolation of a new pathogen (not the original baseline pathogen) from a specimen taken while the participant was on antibiotic therapy (Day 1 to EOT) and having a need for alternative antimicrobial therapy. Rates of emergence of any new pathogen by participant after start of study drug were summarized for each treatment group.|Up to 10 days after start of study treatment|mITT population|||Participants|||Count of Participants
1349893|NCT01799993|Other Pre-specified|Number of Participants With Microbiological Recurrence at LFU Visit|The responses of recurrence were tabulated for each participant. Recurrence was defined as the reappearance of the original pathogen(s) from a specimen taken after the TOC visit. If one or more pathogen reappeared, all isolates from a participant were tabulated as “recurrence”. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.|Up to 28-32 days after start of study treatment|mITT population|||Participants|||Count of Participants
1349894|NCT01799993|Other Pre-specified|Number of Participants With Microbiological Response at TOC Visit|The responses of eradication (defined as the absence of the original pathogen(s) at the post-treatment TOC culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) were tabulated for each participant to reveal the microbiological responses. All pathogen isolates from a participant must be eradicated (or presumed eradicated) to tabulate an eradicated (or presumed eradicated) response. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.|Up to 17-19 days after start of study treatment|mITT population|||Participants|||Count of Participants
1349895|NCT01799993|Other Pre-specified|Number of Participants With Microbiological Response Per Pathogen at TOC Visit|The number of participants with microbiological response for each pathogen among the total number of participants with baseline pathogen isolates for each pathogen was determined. If a participant had 3 pathogens, all 3 were tabulated. Eradication ( defined as the absence of the original pathogen(s) at the post-treatment test-of-cure [TOC] visit culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) rates were reported to reveal the microbiological responses. The data were displayed for each bacterial genus/species. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.|Up to 17-19 days after start of study treatment|mITT population|||Participants|||Count of Participants
1349950|NCT01798992|Primary|Improvement in Left Ventricular Ejection Fraction (LVEF) at 12 Months|The primary clinical outcome will be LVEF response at 12 months defined as an improvement in LVEF of ≥ 8% at 12 months or if not available, ≥5% at 3 months in the absence of an adverse clinical outcome. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months|Idiopathic dilated cardiomyopathy patients naive to beta-blocker therapy|||LVEF responders|||Number
1349896|NCT01799993|Secondary|Number of Days in the ICU Through LFU Visit|Number of days in ICU was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived in ICU through the LFU visit, the ICU days were actual days in ICU with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days in ICU was censored at 28 days. For participants who died or discontinued in ICU, the number of days in ICU was 28 days. Further analysis of the number of days in ICU was to be performed with censoring at Day 28 for subset of participants on ventilation and without censoring.|Up to 28-32 days after start of study treatment|mITT population without missing start or end dates|||day||Standard Deviation|Mean
1349897|NCT01799993|Secondary|Number of Days on Mechanical Ventilation Through LFU Visit|Number of days on mechanical ventilator was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived through the LFU visit, the ventilation days were actual days on ventilation with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days on ventilator was censored at 28 days. For participants who died or discontinued off ventilation, the number of days on ventilation was actual days on ventilation with a maximum value of 28 days. For participants who died or discontinued on ventilation, the number of days on ventilation was 28 days. Further analysis of the number of days on mechanical ventilator was to be performed with censoring at Day 28 for subset of participants on ventilation without censoring.|Up to 28-32 days after start of study treatment|mITT population|||day||Standard Deviation|Mean
1349898|NCT01799993|Secondary|Number of Participants With Early Clinical Response|Early Clinical Response was determined by the following: 1. CPIS scoring at Days 3, 5, and 10 compared to baseline (a. On Day 3, CPIS increase from baseline by at least 2 points was considered a failure. b. On Day 5, CPIS decrease from baseline of at least 1 point was not a failure. CPIS of no change from baseline was considered a failure. Any CPIS increase from baseline was a failure. c. On Day 10, CPIS decrease from baseline of at least 2 points was not a failure. CPIS decrease of only 1 point is a failure. Clinical Pulmonary Infection Score of no change was considered a failure. Any CPIS increase from baseline was a failure). 2. All-cause mortality through EOT visit was a failure. 3. The development of empyema or lung abscess through the EOT visit was a failure.|Up to 10 days after start of study treatment|mITT population|||Participants|||Count of Participants
1349899|NCT01799993|Secondary|Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit|Death through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.|Up to 28-32 days after start of study treatment|Participants who died through LFU visit in mITT population set|||Participants|||Count of Participants
1349900|NCT01799993|Primary|Number of Participants Surviving Through LFU Visit|The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.|Up to 28-32 days after start of study treatment|Modified intent-to-treat (mITT) population (included all subjects who had a culture-confirmed Gram-negative bacteria that had been treated with at least one dose of study treatment, and had an APACHE II score ≥ 10 at the time of diagnosis of pneumonia)|||Participants|||Count of Participants
1349901|NCT01799941|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs (defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) and SAEs (defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening [ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death], required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug) were assessed during the study.|From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days|The analysis was performed using the safety population that consisted of all enrolled patients who received at least 1 dose of study drug.|||Participants|||Number
1349902|NCT01799941|Secondary|Percentage of Participants With Treatment Satisfaction Survey|The treatment satisfaction survey was a 5 point single question survey that was administered by the site staff to the participant/participant’s caregiver. Participants were asked to rate their response to treatment satisfaction as: very dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, and very satisfied. Data is presented as percentage of participants with treatment satisfaction at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The mITT Population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.|||Percentage of participants|||Number
1349903|NCT01799941|Secondary|Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90|PGI-C, a participant/participant’s caregiver-assessed scale was used to measure participant overall treatment response. PGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with PGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PGI-C.|||Percentage of participants|||Number
1349951|NCT01798966|Other Pre-specified|Adverse Events and Serious Adverse Events|Safety will be evaluated throughout the duration of the study by collecting all adverse events|4 days||||Number of AE|||Number
1349952|NCT01798966|Secondary|IOP Patterns|The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients|24 hours||||mvEq||Standard Deviation|Mean
1350119|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 9 months post-vaccination|||||||
1349904|NCT01799941|Secondary|Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90|CGI-C, an investigator-assessed scale was used to measure the overall treatment response. CGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with CGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CGI-C.|||Percentage of participants|||Number
1349905|NCT01799941|Secondary|Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90|The QOL-VAS, a participant reported scale of quality of life (QOL) was used to measure the impact of PBA episodes on the participant’s QOL over the previous 7 days (prior to visit) at Baseline (Day 1) and Day 90 (Final visit). The assessment was completed by a participant placing a mark on a horizontal line that extends from 0 “not (affected) at all” to 10 “significantly (affected)”. The participant’s mark was measured and recorded at each time point. The change in QOL-VAS score from baseline to day 90 visit, defined as the day 90 score minus the baseline score, was analyzed. Data is reported as mean QOL-VAS score; a positive change in score represented an increase in participant’s quality of life.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with QOL-VAS.|||Units on a scale||Standard Deviation|Mean
1349906|NCT01799941|Secondary|Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week|Data is reported as the percentage of participants with ≥ 75% reduction in PBA episode count/week.|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Percentage of participants|||Number
1349907|NCT01799941|Secondary|Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week|Data is reported as the percentage of participants with ≥ 50% reduction in PBA episode count/week.|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Percentage of participants|||Number
1349908|NCT01799941|Secondary|Percentage Change From Baseline in PBA Episode Count Per Week|The change from the baseline PBA rate was measured using Mixed Effects Poisson Regression Model (adjusted for gender and age [≤ 65 years]).|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||percent change||95% Confidence Interval|Mean
1349909|NCT01799941|Secondary|Percentage of Participants With PBA Remission|PBA remission was defined as participants with one or more episodes reported at the baseline (Day 1) visit and zero episodes reported at the Day 30 (Visit 1) or Day 90 (Final visit). Data is reported as percentage of participants with no reported episodes over the previous 7 days (prior to visit) at Day 30 (Visit 1) and Day 90 (Final visit).|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Percentage of participants|||Number
1349910|NCT01799941|Secondary|Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit|PBA episode count was an investigator assessed measure in which the participant/participant’s daytime caregiver was asked to identify, count and recall the total episodes of exaggerated/uncontrollable laughing or crying over the previous 7 days (prior to visit) at Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit). The response categories for this question were: 0, 1- 2, 3-5, 6-10, >10. The original responses from participants were converted to estimate the continuous number of PBA episodes by taking the mid-point of the original response ranges and multiplying that value by 7. Data is presented as mean PBA count per week.|Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Count/week||Standard Deviation|Mean
1349911|NCT01799941|Secondary|Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30|The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant’s caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 30 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.|Day 30|The analysis was performed using the mITT population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.|||Units on a scale||Standard Deviation|Mean
1349953|NCT01798966|Primary|Change in IOP Before and After Orbital Decompression Surgery|To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression|24 hours||||mVEq (Sensismed Triggerfish output unit)||Standard Deviation|Median
1349954|NCT01798927|Other Pre-specified|Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment|data from 3 of the 4 participants was analyzed|||meters||Standard Deviation|Mean
1349912|NCT01799941|Primary|Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90|The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant’s caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 90 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.|Day 90 (Final visit)|The analysis was performed using the Modified Intent-to-treat (mITT) Population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.|||Units on a scale||Standard Deviation|Mean
1349913|NCT01799720|Secondary|Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||Units / litre||Standard Error|Mean
1349914|NCT01799720|Secondary|Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||milligram / decilitre||Standard Error|Mean
1349915|NCT01799720|Secondary|Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||milligram / decilitre||Standard Error|Mean
1349916|NCT01799720|Secondary|Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||milligram / decilitre||Standard Error|Mean
1349917|NCT01799720|Secondary|Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||millimetres of mercury||Standard Error|Mean
1349918|NCT01799720|Secondary|Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||millimetres of mercury||Standard Error|Mean
1349919|NCT01799720|Secondary|Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||ratio*100||Standard Error|Mean
1349920|NCT01799720|Secondary|Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||kilogram / square metre||Standard Error|Mean
1349921|NCT01799720|Secondary|Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the height of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||metres||Standard Error|Mean
1349922|NCT01799720|Primary|Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||kilogram||Standard Error|Mean
1349923|NCT01799590|Secondary|Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score|The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Final evaluation (FE) was done at Day 225 or at discontinuation.|Baseline (28 days before randomization) and FE (Day 225/early discontinuation)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1349924|NCT01799590|Secondary|Percentage of Participants With Response to Treatment|Responders were defined as participants who had a 50 percent or more reduction in frequency of migraine attacks. Migraine is common disabling headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 characteristics: unilateral location, pulsating quality, moderate/severe pain or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (attack with reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes).|Baseline (28 days before randomization) up to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Percentage of participants|||Number
1349925|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period|If aura of migraine, migraine attack or non-migraine headache attack occurred in study, these rescue drugs were permitted:analgesics, non-steroidal anti-inflammatory drugs (NSAIDs),ergotamines,triptans,antiemetics. Drugs with restricted treatment days of less than (<) 15 days per month (28 days):analgesics, NSAIDs,combination of rescue drugs and those with <10 days per month:triptans,ergotamines, opioids,combination analgesics. Average calculated as total number of monthly rescue-drug treatment days divided by the total number of days of assessment and multiplied by 28, where a month = 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
1349926|NCT01799590|Secondary|Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Day 197 to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
1349927|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period|As per 48-hour rule, if the symptom of pain because of migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
1349928|NCT01799590|Secondary|Change From Baseline in the Average Number of Migraine Attacks According to the Diagnostic Criteria of the International Headache Society Per Month in Continuous Treatment Period|Migraine has 2 major subtypes: migraine without aura (minimum 5 attacks of headache lasting for 4-72 hours, has 2 of these characteristics [unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity] and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (2 attacks of headache with typical aura with migraine headache or typical aura with non-migraine headache or typical aura without headache or familial hemiplegic migraine or sporadic hemiplegic migraine or basilar-type migraine).|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
1349929|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period|Migraine headache day was defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Average was calculated as total number of monthly headache days divided by total number of days of assessment and multiplied by 28, where a month was considered to last 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
1349930|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period|Migraine:disabling headache disorder;2 major subtypes:migraine without aura(at least 5 attacks for 4-72 hours with at least 2 characteristics: unilateral location,pulsating quality,moderate/severe pain intensity or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia,phonophobia);migraine with aura(attack with reversible focal neurological symptoms that develop over 5-20 minutes, last for less than 60 minutes);average=total number of migraine attack days divided by total number of days of assessment and multiplied by 28,where a month=28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
1349931|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) was less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
1349932|NCT01799590|Primary|Number of Participants With Adverse Events|An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Baseline up to 28 days after last dose of study drug|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1349933|NCT01799278|Secondary|Circulating Tumor Cell (CTC) Response|CTC counts by CellSearch will be performed at baseline, at 4-6 weeks, and upon progression to determine response.|2 years|Data were not collected for this outcome.||||||
1349934|NCT01799278|Secondary|Prostate-Specific Antigen (PSA) Test Response Rate|PSA to be followed every cycle to determine response.|2 years|Data were not collected for this outcome.||||||
1349935|NCT01799278|Secondary|Overall Survival in Response to Therapy|Patients will be followed for survival endpoints following completion of this study until death|3 years||||months||95% Confidence Interval|Median
1349936|NCT01799278|Secondary|Progression-free Survival in Response to Therapy|Patients will be followed for survival endpoints following completion of this study until death.|3 years||||months||95% Confidence Interval|Median
1350120|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 7 to 9 months post-vaccination|||||||
1349937|NCT01799278|Primary|Response Rate, as Assessed by CT/MRI and Bone Scan, of Treatment With MLN8237 for Patients With Neuroendocrine Prostate Cancer|Evaluated per RECIST 1.1 guidelines: Complete response (CR) is defined as complete disappearance of all measurable and evaluable lesions by physical examination or imaging studies and normalization of PSA with no appearance of new lesions for > 1 month. Partial response (PR) is defined as a 30% 56 or greater reduction in the sum longest unidimensional diameter of all measurable lesions. There may be no new lesions. Stable Disease (SD) is characterized by patients who do not meet the criteria of PR and who are without signs of progressive disease for at least 1 month. Disease Progression (DP) is defined as a greater than 20% increase in the sum longest unidimensional diameters of the indicator lesions or the appearance of new lesions. Bone scan progression (evaluable disease only) is defined by PCWG2 criteria. Per consensus guidelines in CRPC, to be considered measurable, lymph nodes need to be at least 2 cm in greatest dimension and 1.5 cm in short axis.|one year||||participants|||Number
1349938|NCT01799239|Primary|Leakage (Percentage of All Baseplates With Leakage)|"leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate.~The subjects tick of one of the four possible answers:~No leakage~Starting to leak (leakage under the baseplate)~Leakage (seepage of faeces resulting in leakage on clothes)~Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)"|After each baseplate change over a period, of 7 days||||percentage baseplates with leakage|Participants||Number
1349939|NCT01799226|Other Pre-specified|Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.|A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.|Baseline to 35 Days|||||||
1349940|NCT01799226|Other Pre-specified|Plaque Samples Will be Collected for Bacterial Species Detection.|Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.|Baseline to 35 Days|||||||
1349941|NCT01799226|Other Pre-specified|Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.|Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).|Baseline to 35 Days|||||||
1349942|NCT01799226|Primary|Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35|Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).|||units on a scale||Standard Error|Mean
1349943|NCT01799226|Secondary|Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35|Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).|||units on a scale||Standard Error|Mean
1349944|NCT01798992|Other Pre-specified|Change in Myocardial microRNA Expression at 12 Months|Changes in myocardial microRNA expression at 12 months compared to baseline using an Affymetrix microRNA microarray assay. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months|||||||
1349945|NCT01798992|Other Pre-specified|Change in Myocardial microRNA Expression at 3 Months|Changes in myocardial microRNA expression at 3 months compared to baseline using an Affymetrix microRNA microarray assay. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|3 months|||||||
1349946|NCT01798992|Other Pre-specified|Change in Myocardial Gene Expression at 12 Months|Changes in myocardial mRNA expression at 12 months compared to baseline using targeted quantitative polymerase chain reaction and Affymetrix genome-wide microarray assays. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months|||||||
1349947|NCT01798992|Other Pre-specified|Change in Myocardial Gene Expression at 3 Months|Changes in myocardial mRNA expression at 3 months compared to baseline using targeted quantitative polymerase chain reaction and genome wide microarray assays. Due to the large number of results genes interrogated (~ 20,000 genes), these results will instead be uploaded to the Gene Expression Omnibus.|3 months|||||||
1349948|NCT01798992|Secondary|Composite of All-cause Mortality, Need for Heart Transplant or Need for Ventricular Assist Device.|Clinical status at 18 months will be assessed at time of study completion, specifically for the composite outcome of all-cause mortality, need for heart transplant, or need for ventricular assist device. Outcomes are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|18 months|Idiopathic dilated cardiomyopathy patients randomized to different beta-blocker strategies. Data does not include non-failing controls, as these patients only underwent baseline evaluation with no treatment or follow-up, given that they did not have heart failure.|||participants|||Number
1349949|NCT01798992|Secondary|Improvement in LVEF at 3 Months|A secondary outcome will be LVEF response at 3 months, defined as an improvement of ≥ 5% Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|3 months||||LVEF responders|||Number
1349988|NCT01798394|Secondary|Protocol Compliance - EDC's Completed|Compliance was measured as the number by number of EDCs completed (maximum of 84).|Gestational Week 36 - Postpartum Week 12||||EDC's completed||Standard Deviation|Mean
1349955|NCT01798927|Secondary|Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.|EMG data was analyzed from 3 of the 4 participants|||participants|||Number
1349956|NCT01798927|Primary|Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment|step length was analyzed from the GAITRite|||cm||Standard Deviation|Mean
1349957|NCT01798706|Secondary|Percentage of Participants With Gastrointestinal Disorders||Up to Day 171|Analysis was performed on safety population.|||percentage of participants|||Number
1349958|NCT01798706|Secondary|Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 24|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|||percentage of participants|||Number
1349959|NCT01798706|Secondary|Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)|Analysis was performed on safety population defined as all randomized participants who received any amount of study drug.|||percentage of participants|||Number
1349960|NCT01798706|Secondary|Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)|Change in basal insulin dose was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline basal insulin dose assessment during on-treatment period.|||units||Standard Error|Least Squares Mean
1349961|NCT01798706|Secondary|Change in Plasma Glucose Excursions From Baseline to Week 24|Plasma glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the liquid standardized breakfast meal test, before study drug administration. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants=participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1349962|NCT01798706|Secondary|Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 mg/dL (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >9%.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1349963|NCT01798706|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1349964|NCT01798706|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||kg||Standard Error|Least Squares Mean
1349965|NCT01798706|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1349989|NCT01798394|Secondary|Protocol Compliance - Doses of Medication Taken|Compliance was measured by doses of medication taken (maximum of 56).|Postpartum Week 0 - Week 12||||Doses of medication taken||Standard Deviation|Mean
1350121|NCT01797029|Secondary|Safety Profile of LAIV: Immediate Reactions||30 minutes post-vaccination||||participants|||Number
1349966|NCT01798706|Secondary|Change in 2-Hour PPG From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1349967|NCT01798706|Primary|Absolute Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed=participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent to treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1349968|NCT01798550|Other Pre-specified|Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level||Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days||||Participants|||Count of Participants
1349969|NCT01798550|Other Pre-specified|Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level||Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days||||Participants|||Count of Participants
1349970|NCT01798550|Other Pre-specified|Median Steady State Anti-Xa Levels|The goal anti-Xa peak level range was defined as 0.5 – 1.1 International units/mL. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.|Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days||||IU/mL||Inter-Quartile Range|Median
1349971|NCT01798550|Secondary|Time to Therapeutic Anti-Xa Level for Both Groups|Time to therapeutic Anti-Xa = time in hours from enoxaparin dose #1 to the first therapeutic Anti-Xa. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.|Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days||||hours||Inter-Quartile Range|Median
1349972|NCT01798550|Primary|Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group||3-5 hours after at least 3rd dose||||Participants|||Count of Participants
1349973|NCT01798485|Secondary|Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test|"The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.~Data were not summarized due to the early termination of the study due to futility."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants||||||
1349974|NCT01798485|Secondary|Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and “0” represents dead, with some health states being worse than dead (<”0”).~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.||||||
1349975|NCT01798485|Secondary|Participants With Treatment-Emergent Adverse Events as of 23 December 2015|"Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|up to 36 months|Safety population|||participants|||Number
1349976|NCT01798485|Other Pre-specified|Exploratory Biomarker Analyses|Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|up to 36 months|Randomized||||||
1349977|NCT01798485|Secondary|Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015|Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.|up to 36 months|Randomized participants|||percentage of participants|||Number
1350122|NCT01797029|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through one week post-vaccination|||||||
1349978|NCT01798485|Secondary|Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015|TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment.|up to 36 months|Randomized participants|||months||95% Confidence Interval|Median
1349979|NCT01798485|Secondary|Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD).~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks.~Elevated LDH includes values above the upper limit of normal.~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.||||||
1349980|NCT01798485|Secondary|Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~Elevated LDH includes values above the upper limit of normal.~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.||||||
1349981|NCT01798485|Secondary|Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.~Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Elevated LDH includes values above the upper limit of normal."|up to 36 months|Randomized participants who had an elevated screening LDH|||months||95% Confidence Interval|Median
1349982|NCT01798485|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015|"Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis.~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants who had a confirmed response|||months||95% Confidence Interval|Median
1349983|NCT01798485|Secondary|Disease Control Rate (DCR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD).~CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks."|up to 36 months|Randomized participants|||percentage of participants||95% Confidence Interval|Number
1349984|NCT01798485|Secondary|Objective Response Rate (ORR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).~CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants|||percentage of participants||95% Confidence Interval|Number
1349985|NCT01798485|Secondary|Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal.|up to 36 months|Randomized participants with elevated LDH at screening|||months||95% Confidence Interval|Median
1349986|NCT01798485|Secondary|Progression-free Survival (PFS) as of 19 October 2015|"The progression–free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.~Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|up to 36 months|Randomized participants|||months||95% Confidence Interval|Median
1349987|NCT01798485|Primary|Overall Survival as of 19 October 2015|Overall survival (OS) was measured from the date of randomization to the date of death from any cause.|up to 36 months|Randomized participants|||months||95% Confidence Interval|Median
1349990|NCT01798394|Secondary|Compliance Determinants|This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.|Postpartum Week 12||||units on a scale||Standard Deviation|Mean
1349991|NCT01798394|Secondary|Protocol Compliance - Number of Visits Attended|Compliance was measured as the number of visits attended (maximum of 5).|Gestational Week 36 - Postpartum Week 12||||Number of visits attended||Standard Deviation|Mean
1349992|NCT01798394|Secondary|Number of Participants Who Relapsed at All During Postpartum (up to Day 84)|Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.|Postpartum Day 0 to 84||||participants|||Number
1349993|NCT01798394|Secondary|Number of Participants Who Relapsed by Week 12 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 12 Postpartum||||participants|||Number
1349994|NCT01798394|Primary|Number of Participants Who Relapsed by Week 4 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 4 Postpartum||||participants|||Number
1349995|NCT01798316|Other Pre-specified|Narcotic Use During PACU Stay|Narcotic medication administered during PACU stay in morphine milligram equivalents|4 hours plus/minus 30 minutes||||Morphine milligram equivalents||95% Confidence Interval|Mean
1349996|NCT01798316|Other Pre-specified|Number of Patients Requiring Rescue Analgesia for Breakthrough Pain|Number of patients requiring rescue analgesia medication during first hour of PACU stay|1 hour following surgery||||Participants|||Count of Participants
1349997|NCT01798316|Secondary|Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale|Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities|1 hour following surgery||||Units on a numerical rating scale||Inter-Quartile Range|Median
1349998|NCT01798316|Secondary|Patient Satisfaction on a 5 Point Likert Scale|Number of patients very satisfied or satisfied with pain and PONV management during hospital stay|Up to one week following surgery|Post-discharge follow up group. Patients not included in analysis were lost to follow up.|||Participants|||Count of Participants
1349999|NCT01798316|Secondary|Highest Pain Intensity Score Using Numeric Rating Scale (NRS)|Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.|4 hours plus/minus 30 minutes||||Units on a numerical rating scale||Inter-Quartile Range|Median
1350000|NCT01798316|Secondary|Number of Participants With Post Discharge Nausea and Vomiting (PDNV)|"Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery.~PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge."|Up to two days following surgery|Post-discharge follow up group. Patients not included in analysis were lost to follow up.|||Participants|||Count of Participants
1350001|NCT01798316|Primary|Number of Participants With Postoperative Nausea and Vomiting (PONV).|"Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay.~PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching."|4 hours plus/minus 30 minutes||||Participants|||Count of Participants
1350002|NCT01798264|Secondary|Change in Weight From Baseline to 4 Weeks||4 weeks||||kg||Standard Deviation|Mean
1350003|NCT01798264|Secondary|Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline||4 weeks||||mg/dL||Standard Deviation|Mean
1350004|NCT01798264|Secondary|To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus|Change in HbA1c from baseline|4 weeks||||percentage||Standard Deviation|Mean
1350005|NCT01798264|Primary|Number of Subjects With Study Drug-Related Adverse Events||4 weeks|Number of subjects reporting study drug-related adverse events|||participants|||Number
1350006|NCT01798186|Secondary|Subjective VAS Drug Effect|"Visual analog scale (0-100; not at all to extremely) of subjective Drug Effect"|immediately post cannabis exposure.||||mm||Standard Deviation|Mean
1350007|NCT01798186|Secondary|Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid|After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.|Samples collected 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure||||ng/mL||Full Range|Mean
1350008|NCT01798186|Primary|Delta-9-tetrahydrocannabinol (THC) Cmax in Blood|After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.|0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure||||ng/mL||Standard Deviation|Mean
1350009|NCT01798134|Secondary|12 Month Survival||12 months||||participants|||Number
1350010|NCT01798134|Primary|Freedom From Tumor Progression at 6 Months|Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|For efficacy outcomes, there were 21 participants with imaging to assess tumor response. No imaging was available for the other participants.|||participants|||Number
1350011|NCT01798134|Primary|Freedom From Study Related SAE at 6 Months||Up to 6 months|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.|||participants|||Number
1350012|NCT01798134|Primary|Freedom From Serious Adverse Event (SAE) at 30days||Up to 30 days|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.|||participants|||Number
1350123|NCT01797029|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 7 to 9 months post-vaccination||||percentage of participants|||Number
1350013|NCT01798056|Secondary|Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From 30 days post last vaccination up to study end (Month 13)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
1350014|NCT01798056|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.|From 30 days post last vaccination up to study end (Month 13)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
1350015|NCT01798056|Secondary|Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups|Vaccine response defined as: For initially seronegative subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); For initially seropositive subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.|At Months 1, 2 and 13|The analysis was performed on the PreChemo groups from the Adapted ATP cohort for Cell Mediated Immunity (CMI) immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for CMI immunogenicity.|||Participants|||Count of Participants
1350016|NCT01798056|Secondary|Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups|Descriptive statistics were tabulated for CD4[2+] cells, which are gE-specific CD4+ T-cells with at least 2 activation markers ([2+]) expressed from the activation markers IFN-γ, IL-2, TNF-α and CD40 L, as determined by intra-cellular staining (ICS) method.|At Months 0, 1, 2 and 13|The analysis was performed on the PreChemo groups from the Adapted ATP cohort for Cell Mediated Immunity (CMI) immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for CMI immunogenicity.|||CD4 T-cells/million T-cells||Inter-Quartile Range|Median
1350017|NCT01798056|Secondary|Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations|Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/ml); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|At Months 1, 2, 6 and 13|The analysis was performed on the Adapted ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for Humoral Immunogenicity.|||Participants|||Count of Participants
1350018|NCT01798056|Secondary|Anti-VZV gE Antibody Concentrations|Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.|At Months 0, 1, 6 and 13|The analysis was performed on the Adapted ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for Humoral Immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1350019|NCT01798056|Primary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered|||Participants|||Count of Participants
1350020|NCT01798056|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE= SAE assessed by the investigator as causally related to the study vaccination.|From first dose up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
1350021|NCT01798056|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
1350022|NCT01798056|Primary|Number of Days With Solicited General Symptoms|The number of days with any general symptoms has been assessed during the post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1350039|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses|Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.|Up to Day 30|This reporting group includes all randomized and dispensed participants who completed the study.|||participants|||Number
1350314|NCT01792024|Secondary|The Total Number of Patients With Any Adverse Events Related to the Treatment|Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|1,3, and 12 month after treatment and up to 12 months||||Participants|||Count of Participants
1350023|NCT01798056|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal [symptoms included nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, shivering and fever [defined as oral, axillary or timpanic temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Participants|||Count of Participants
1350024|NCT01798056|Primary|Number of Days With Solicited Local Symptoms|The number of days with any local symptoms has been assessed during the post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1350025|NCT01798056|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Participants|||Count of Participants
1350026|NCT01798056|Primary|Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations|Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.|At Month 2|The analysis was performed on the ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time point Month 2 data were obtained from the ATP cohort for Humoral Immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1350027|NCT01798056|Primary|Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups|Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.|At Month 2|The analysis was performed on the PreChemo groups from the According-to-Protocol (ATP) cohort for Humoral immunogenicity which included all evaluable subjects up to 30 days post last vaccination and who had met all eligibility criteria and complied with the procedures and intervals defined in the protocol for active phase of the study.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1350028|NCT01798004|Other Pre-specified|Melphalan Pharmacokinetics and the Combination of Busulfan and Melphalan AUC (Optional)|A descriptive analysis of the relationship between melphalan pharmacokinetics and the combination of busulfan and melphalan AUC with the occurrence of non-hematologic toxicities within 28 days following completion of consolidation will be assessed. In addition, the association between melphalan exposure levels as measured by the AUC and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days post-consolidation|||||||
1350029|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients With MYCN Non-amplified Tumors for Whom Molecular Profiling Results Can be Obtained||Within 8 weeks of diagnosis|||||||
1350030|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients for Whom ALK Status Can be Obtained||Within 6 weeks of diagnosis|||||||
1350031|NCT01798004|Other Pre-specified|Percentage of MIBG Scans Receiving Institutionally and Centrally Reviewed and Automated Advanced Assisted Scoring Platform Curie Scores Within 1 Unit of Each Other|Cohen's kappa will be calculated to evaluate the concordance in Curie scores between each of the scoring methods at each time point. Up to 160 MIBG scans are expected at diagnosis and up to 144 MIBG scans from the 90% of patients estimated to be MIBG avid are projected post-course 4 of induction therapy, for a total of up to 304 MIBG scans.|Up to week 12 (course 4 of induction therapy)|||||||
1350032|NCT01798004|Other Pre-specified|Percentage of Centrally Reviewed Post-course 4 MIBG Scans Reporting a Curie Score Considered to Have Been Determined in “Real Time”||Up to week 12 (course 4 of induction therapy)|||||||
1350033|NCT01798004|Other Pre-specified|First Dose Area Under the Curve (AUC) and Average Daily AUC for Busulfan|Relationship with occurrence of non-hematologic toxicities assessed by a descriptive analysis. Association between busulfan exposure levels as measured by the area under the curve (AUC) and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days following consolidation|||||||
1350034|NCT01798004|Other Pre-specified|Overall Survival||Up to 5 years|||||||
1350035|NCT01798004|Other Pre-specified|EFS||Up to 5 years|||||||
1350036|NCT01798004|Other Pre-specified|Response Rate Determined Using the International Response Criteria||Up to 5 years|||||||
1350037|NCT01798004|Other Pre-specified|Incidence of Non-hematologic Organ Toxicity (Grade 3 and Higher) and All Cause Mortality Graded According to CTC v4.0|Assessed by a descriptive analysis of the incidence of grade 3-5 non-hematologic toxicities (CTC v4.0) and all-cause mortality during consolidation therapy. In addition, a descriptive analysis of “late” onset grade 4-5 pulmonary and hepatic complications that occur within 180 days of the start of consolidation therapy will be examined, regardless if the patient has proceeded to other therapy (including chimeric antibody) during that 180 day period.|Up to 180 days|||||||
1350038|NCT01798004|Primary|The Tolerability of BuMel Regimen|Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome [SOS] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria [CTC] v.4.0) during the Consolidation phase of therapy.|Up to 28 days post-consolidation therapy, up to 1 year|All eligible and evaluable patients who received at least one dose of either busulfan or melphalan.|||participants|||Number
1350063|NCT01797471|Secondary|Overall Survival (OS)|Rate of overall survival (OS) in study participants. Overall survival is defined as the length of time from the date of treatment initiation until the date of death from any cause.|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
1350040|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses|Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the ’normal’ visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.|Up to Day 30|This analysis population includes all randomized and dispensed participants who completed the study.|||participants|||Number
1350041|NCT01797783|Primary|Subjective Overall Vision|"The participant was instructed to, Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision. The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent)."|Up to Day 30|"This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm.~group,"|||Units on a scale||Standard Deviation|Mean
1350042|NCT01797731|Secondary|Time Required to Utilize System|The amount of time required to utilize conventional, tibial extramedullary alignment guides versus the KneeAlignTM system, which will be recorded intraoperatively.|Minutes during surgery ( Estimated time per surgery 1 hour)||||seconds||Standard Deviation|Mean
1350043|NCT01797731|Primary|Postoperative Tibial Component Alignment|The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.|6 weeks after surgery||||percentage of participants|||Number
1350044|NCT01797705|Primary|% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study|The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an “agree” or “disagree.” Pressure changes might show no change, increase or decrease during the 20-minute epoch.|1 night|Subjects completing the study with evaluable results|||percentage of agreement||95% Confidence Interval|Number
1350045|NCT01797575|Secondary|Oxidative Stress as Indicated by Serum Thiobarbituric Acid Reactive Substances (TBARS) Levels||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
1350046|NCT01797575|Secondary|Oxidative Stress as Indicated by Catalase Activity||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
1350047|NCT01797575|Secondary|Oxidative Stress as Indicated by Superoxide Dismutase Activity||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
1350048|NCT01797575|Secondary|Inflammation as Indicated by Tumor Necrosis Factor (TNF)-Alpha Levels||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
1350049|NCT01797575|Secondary|Inflammation as Indicated by Soluble Interleukin-2 (IL-2) Receptor Levels||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
1350050|NCT01797575|Secondary|Inflammation as Indicated by Interleukin 6 (IL-6) Levels|Interleukin 6 (IL-6) is an interleukin that acts as a pro-inflammatory cytokine and an anti-inflammatory myokine. IL-6 is measured in picograms (pg) per milliliter (mL). Elevated interleukin-6 indicates potential immune system dysregulation and increased inflammation.|baseline, week 8, week 16|Row numbers differ from overall number analyzed either due to patient withdrawal from study prior to completion, or from failure to obtain a blood sample from patient during study. Overall number analyzed differs from overall number of baseline participants for the same reason.|||picograms per milliliter||Standard Deviation|Mean
1350051|NCT01797575|Secondary|Inflammation as Indicated by C-reactive Protein (CRP) Levels|C-reactive protein (CRP) levels are blood test markers of inflammation. Higher CRP corresponds with higher levels of inflammation. CRP is measured in milligrams per liter.|baseline, week 8, week 16|Row numbers differ from overall number analyzed either due to patient withdrawal from study prior to completion, or from failure to obtain a blood sample from patient during study. Overall number analyzed differs from overall number of baseline participants for the same reason.|||milligrams per liter||Standard Deviation|Mean
1350052|NCT01797575|Primary|Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size.|Received drug for 8 weeks during week 9 to week 16 of the study|Patients who responded to treatment during week 0-8 were maintained on current treatment. Patients who did no respond were re-randomized for week 9-16.|||Participants|||Count of Participants
1350053|NCT01797575|Primary|Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size.|Received drug for 8 weeks during week 0 to week 8 of the study||||Participants|||Count of Participants
1350054|NCT01797575|Primary|Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts.|Received drug for 8 weeks during week 9 to week 16 of the study|Patients who responded to treatment during week 0-8 were maintained on current treatment. Patients who did no respond were re-randomized for week 9-16.|||Participants|||Count of Participants
1350055|NCT01797575|Primary|Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery–Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts.|Received drug for 8 weeks during week 0 to week 8 of the study||||Participants|||Count of Participants
1350056|NCT01797536|Primary|Apparent Terminal Half-Life (t1/2) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the t1/2 of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||hr||Geometric Coefficient of Variation|Geometric Mean
1350057|NCT01797536|Primary|Time to Maximum Concentration (Tmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||hour (hr)||Full Range|Median
1350058|NCT01797536|Primary|Concentration at 24 Hours (C24) After Dosing Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.|Hour 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||nM||95% Confidence Interval|Geometric Mean
1350059|NCT01797536|Primary|Maximum Concentration (Cmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||nM||95% Confidence Interval|Geometric Mean
1350060|NCT01797536|Primary|Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||μM•hr||95% Confidence Interval|Geometric Mean
1350061|NCT01797536|Primary|Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||μM•hr||95% Confidence Interval|Geometric Mean
1350062|NCT01797484|Primary|Left Ventricular Global Strain Rate|Relativ acceleration or deceleration (1/s) of left ventricular myocardial sections compared to direct opposite section. The more positive the value, the more simultaneously the movements, the more hemodynamically better.|42 days after first dose of Ranolazine|Secondary Outcome Measure data was not collected. Initially planned secondary outcome (e.g. cardiac events) was found to interfere with monitoring drug safety|||percentage of change||Standard Deviation|Mean
1350315|NCT01792024|Secondary|The Number of Patients With Biopsy Cancer of the Treatment Zone|A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.|At 12 months||||Participants|||Count of Participants
1350064|NCT01797471|Secondary|Progression-Free Survival (PFS)|Rate of progression-free survival (PFS). PFS is defined as the length of time from date of treatment initiation until date of documented disease progression or death from any cause, with censoring of patients who are lost to follow-up.|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
1350065|NCT01797471|Secondary|Rate of Loco-regional Failure in Study Participants|Rate of loco-regional failure in study participants. Loco-regional failure is defined as any evidence of disease progression within the primary primary tumor or regional lymph nodes, detected by any method.|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
1350066|NCT01797471|Secondary|Rate of Study Participants Achieving Complete or Partial Response Via PET Response Criteria|"Rate of subjects achieving complete response (CR) or partial response (PR) as detected by positron emission tomography (PET) Scan:~CR is defined as no residual focal fluorodeoxyglucose (FDG) uptake or decrease in average FDG uptake by more than 80% in all tumor manifestations.~PR is defined as standardized uptake value (SUV) decrease by 0 - 80%."|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
1350067|NCT01797471|Secondary|Rate of Study Participants Achieving Complete or Partial Response Via CT RECIST Response Criteria|"Number of subjects achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria on CT Scan:~CR: Complete disappearance of all disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same technique as baseline.~PR: Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions."|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
1350068|NCT01797471|Primary|Rate of Treatment-related Toxicity in Study Participants|Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants. Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.|Up to 12 months|Study participants experiencing treatment-related esophagitis or pneumonitis.|||Participants|||Count of Participants
1350069|NCT01797458|Other Pre-specified|Number of Participants Reporting Pain Experience During Treatment|Child's perception of pain intensity during treatment was assessed using the Visual Analogue Scale of Faces. It is a five-point scale, which includes five faces of children representing from very light to very intense pain. Participants were asked to select the face that represents how he/she felt during the procedure.|Baseline assessment||||Participants|||Count of Participants
1350070|NCT01797458|Other Pre-specified|Number of Participants With Negative and Positive Behavior During Treatment|Behaviour of children during treatment was assessed using the Frankl Behavior Rating Scale. It is a four-point scale, which ranges from definitely negative behaviour, when the child refuses the treatment to definitely positive behaviour, when the participant is completely cooperative.|Baseline assessment||||Participants|||Count of Participants
1350071|NCT01797458|Other Pre-specified|Oral Health Status|Child`s oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years|1 and 2 years|||||||
1350072|NCT01797458|Secondary|Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction|Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years|2 years||||Participants|||Count of Participants
1350073|NCT01797458|Primary|Failure Rate of the Three Treatment Arms Judged Clinically|Failure rate of the three treatment arms judged clinically after 2 years such as clear caries progression, secondary caries, loss of restoration, reversible pulpitis treated without requiring pulpotomy|2 years||||Teeth|||Number
1350074|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1350075|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1350076|NCT01797445|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1350077|NCT01797445|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1350078|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 96 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1350079|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1350080|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
1350083|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
1350084|NCT01797445|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
1350085|NCT01797445|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
1350086|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1350087|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1350088|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48 and 96|Full Analysis Set|||percentage of participants|||Number
1350089|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Full Analysis Set|||percentage of participants|||Number
1350090|NCT01797445|Primary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants were randomized and received at least one dose of study drug|||percentage of participants|||Number
1350091|NCT01797380|Primary|Reduction in Depressive Symptoms|Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.|9 weeks.|Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data.||||||
1350092|NCT01797328|Primary|Brown Adipose Tissue, Absolute Volume|Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)|Baseline and 6 week|Brown adipose tissue volume (liters)|||liters||Standard Deviation|Mean
1350093|NCT01797120|Secondary|Overall Survival|Overall survival will be characterized using Kaplan-Meier plots and other descriptive metrics.|Every 3 months until progression or up to 3 years|all randomized patients|||months||95% Confidence Interval|Median
1350094|NCT01797120|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete or partial response (by Physical Exam, CT or MRI) divided by number of patients randomized in each arm|Every 3 months until progression or up to 3 years|all randomized patients|||proportion of patients||95% Confidence Interval|Number
1350095|NCT01797120|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as number of patients with objective response (complete response or partial response) or stable disease for at least 24 weeks divided by number of patients randomized in each arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease; Complete Response (CR) is defined as disappearance of all target lesions.|Every 3 months until progression or up to 3 years|all randomized patients|||proportion of patients||95% Confidence Interval|Number
1350096|NCT01797120|Primary|Progression-free Survival|Progression-free survival documented by Physical Exam, CT Scan or MRI in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone from randomization to documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 3 months until progression or up to 3 years|all randomized patients|||months||95% Confidence Interval|Median
1350097|NCT01797094|Secondary|Percentage of Participants Mostly or Very Satisfied With Their Crow’s Feet Lines on the Facial Line Satisfaction Questionnaire|Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
1350098|NCT01797094|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.|||percentage of participants|||Number
1350885|NCT01785524|Primary|Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption|Baseline & 16 Weeks||||ml/kg/min||Standard Deviation|Mean
1350099|NCT01797094|Secondary|Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: “My facial lines make me look tired” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 8 scores ≥ 3 at Baseline were included in the analysis.|||percentage of participants|||Number
1350100|NCT01797094|Secondary|Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: “My facial lines make me look less attractive than I want to look” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 5 scores ≥2 at Baseline are included in the analysis.|||percentage of participants|||Number
1350101|NCT01797094|Secondary|Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : “When I look in the mirror, my facial lines make me look older than I want to look” score.|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 2 scores ≥2 at Baseline are included in the analysis.|||percentage of participants|||Number
1350102|NCT01797094|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow’s Feet Lines (SGA-CFL)|Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
1350103|NCT01797094|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
1350104|NCT01797081|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.|||percentage of participants|||Number
1350105|NCT01797081|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow’s Feet Lines|Participants rated the change in their Crow's Feet Lines using the Subject’s Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
1350106|NCT01797081|Secondary|Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A|The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, all enrolled participants, with data available for analysis.|||percentage of participants|||Number
1350107|NCT01797081|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
1350108|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (All Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination|||||||
1350109|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination|||||||
1350110|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 16 to 19 months post-vaccination|||||||
1350111|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 7 to 9 months post-vaccination|||||||
1350112|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 16 to 19 months post-vaccination|||||||
1350113|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 16 to 19 months post-vaccination|||||||
1350124|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.|||units on a scale||Full Range|Mean
1350125|NCT01796977|Secondary|To Assess Pain Using the Numerical Rating Scale|"Numerical Rating Scale (NRS) - range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|30 days|There is just one NRS value calculated for the indicated time-frame, and thus a comparison between study groups with respect to this outcome was not made. The single NRS value at 30 days is reported here. One patient did not provide follow-up data at this time-point, and thus the total number of participants is 26 instead of 27 for this outcome.|||units on a scale||Standard Deviation|Mean
1350126|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
1350127|NCT01796977|Primary|Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy|Wound Complication Rate|30 days|Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing.|||breasts|Participants||Number
1350128|NCT01796964|Secondary|Central Subfield Thickness (CSFT) Change From Baseline by Visit|CSFT (average thickness in the central subfield centered at the fovea) as measured using Spectral-Domain Optical Coherence Tomography (SD-OCT). Reduction in CSFT measurement from baseline indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||microns||Standard Deviation|Mean
1350129|NCT01796964|Secondary|Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. This outcome measure was pre-specified for ESBA1008 arm only. One eye (study eye) contributed to the analysis.|Week 36, Week 44, Week 48, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350130|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following Treatment by Visit|The purpose of this outcome measure was to assess the potential treatment needs present at these treatment visits. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350131|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month|The purpose of this outcome measure was to assess the stability of BCVA during the second month of 8-week/12-week treatment cycles and specifically to identify potential under treatment. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350142|NCT01796548|Secondary|Total Incontinence Episodes|Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point. This study is early terminated and there were some missing data for total incontinence which lead to decrease value of total incontinence."|||Episodes||Standard Deviation|Mean
1350316|NCT01792024|Primary|Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment|The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.|At 3 months after ablation||||Participants|||Count of Participants
1350132|NCT01796964|Secondary|Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56|The purpose of this outcome measure was to assess the average maintenance level of BCVA following the 3 loading treatments (ie, after Week 12). BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from Week 12 to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350133|NCT01796964|Secondary|Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56|The purpose of this outcome measure was to assess the integrated effect of the treatment for different study periods and to provide more robust estimate of the absolute treatment effects. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from baseline to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350134|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) by Visit|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350135|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) to Week 16|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 16|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350136|NCT01796964|Primary|Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12|This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 12|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
1350137|NCT01796860|Other Pre-specified|Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices as necessary.|6MWT will be done at the time of enrollment and week 13.||||meters||Standard Deviation|Mean
1350138|NCT01796860|Secondary|Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in muscle activity would be things like large changes in amplitude of muscle firing or changes in the timing of muscle firing, for example. These would indicate changes in strength or perhaps motor learning as a result of wearing the ankle foot orthosis.|Surface EMG will be done at the time of enrollment and week 13.||||participants|||Number
1350139|NCT01796860|Primary|Change in Step Length From Initial Testing to End of Study|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Computerized gait analysis will be done at the time of enrollment and week 13.||||measure of length (cm)||Standard Deviation|Mean
1350140|NCT01796548|Secondary|King Health Questionnaire Score|King Health Questionnaire assesses the physical and psycho-social aspects of the disease state. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response. Lower scores indicates better outcome or response.|Baseline and Week 12|"ITT population. Here N signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1350141|NCT01796548|Secondary|Percentage of Participants With no Episodes of Urge-Urinary Incontinence|Percentage of participants with no episodes of urge urinary incontinence was reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.|Baseline, Week 4 and Week 12|Data was not reported for this OM, as data was not analyzed because of change in the planned analysis of the study.||||||
1350143|NCT01796548|Secondary|Urge Incontinence Episodes|Urge incontinence episodes were reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point."|||Episodes||Standard Deviation|Mean
1350144|NCT01796548|Secondary|Reflex Volume|Reflex volume is the infused volume that induces the first detrusor contraction.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).||||||
1350145|NCT01796548|Secondary|Post-Void Residual Urine Volume|Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.|Baseline and Week 12|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure at a particular time point."|||Milliliter (ml)||Standard Error|Mean
1350146|NCT01796548|Secondary|Detrusor Leakpoint Pressure|Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure. This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).||||||
1350147|NCT01796548|Secondary|Maximal Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds.|Baseline and Week 12|ITT population.|||Milliliter (ml)||Standard Deviation|Mean
1350148|NCT01796548|Primary|Maximal Detrusor Pressure|Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.|Week 12|The Intent-to treat (ITT) population included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.|||Centimeter of water||Standard Deviation|Mean
1350149|NCT01796236|Secondary|Inflammation|Max of Holgers index from day 10 to month 12 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.|Day 10 to 12 Months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||participants|||Number
1350150|NCT01796236|Secondary|Surgery Time|Surgery time (minutes) was recorded|Day 0|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||minutes||Standard Deviation|Mean
1350151|NCT01796236|Secondary|Wound Healing|A surgeon or a surgical nurse determined if the wound was healed or not healed.|Day 10, Weeks 3, 6, 12 and 24|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There was only a statistically significant difference between the two groups in this population at day 10.|||participants|||Number
1350152|NCT01796236|Secondary|Pain in the Scar and Neuropathic Pain|The subject rated the following questions ‘has the scar been painful the past few weeks’ and ‘have you had any neuropathic pain during the past weeks’ on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.|Day 10, Weeks 3, 6, 12, 24 and Month 12|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward. There were only statistically significant differences between the two groups in this population at 3 and 12 weeks and only regarding neuropathic pain.|||units on a scale||Standard Deviation|Mean
1350153|NCT01796236|Secondary|Numbness|Numbness summary analysis.|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||participants|||Number
1350154|NCT01796236|Primary|Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability|"Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:~Holgers Index >=2 any time between 3 weeks to 1 year~Any overgrowth any time between 3 weeks to 1 year~Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year~Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject."|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||participants|||Number
1350155|NCT01795937|Secondary|AUC0-tz of Rosuvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1350156|NCT01795937|Primary|Cmax of Rosuvastatin|"Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1350157|NCT01795937|Primary|AUC0-∞ of Rosuvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1350158|NCT01795937|Secondary|AUC0-tz of Atorvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1350159|NCT01795937|Secondary|Cmax,ss of Faldaprevir (Statins Part)|Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1350160|NCT01795937|Secondary|AUCτ,ss of Faldaprevir (Statins Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1350161|NCT01795937|Primary|Cmax of Atorvastatin (Statins Part)|"Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1350162|NCT01795937|Primary|AUC0-∞ of Atorvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.|"PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).~Pharmacokinetic set (PK set): all treated subjects of the statins part that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1350163|NCT01795937|Primary|Cmax,ss (Itraconazole Part)|"Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.|PK set of the itraconazole part of this trial.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1350164|NCT01795937|Primary|AUCτ,ss (Itraconazole Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods|pharmacokinetic (PK) set of the itraconazole part of this trial. The PK set included all treated subjects of the itraconazole part that provided at least 1 observation for at least 1 primary endpoint without important protocal violations with respect to the statistical evaluation of the PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1350165|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant|CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Participants|||Number
1350166|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician|CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Participants|||Number
1350167|NCT01795898|Primary|Number of Participants Requiring Rescue Medication|Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication.|Day 30|All participants suffering from osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) and chronic (lasting a long time) low back pain and who took at least 1 dose of study medication and had at least 1 follow-up visit during the study.|||Participants|||Number
1350185|NCT01795534|Primary|Time to Complete a 10 km Run|Time taken following consumption of beetroot shot or consumption of placebo shot|Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)||||Seconds||Standard Deviation|Mean
1350186|NCT01795495|Secondary|Post-operative Pain Scores|VAS pain score - 0 being no pain and 10 being worst pain.|Post-operatively to 24 hours||||units on a scale||Standard Deviation|Mean
1350168|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Units on a scale||Standard Deviation|Mean
1350169|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The intent-to-treat (ITT) population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Units on a scale||Standard Deviation|Mean
1350170|NCT01795859|Secondary|Change in Berg Balance Test (BBT)|The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.|Baseline, 12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects with missing value at Week 12, the last available assessment was used|||units on a scale||Standard Deviation|Least Squares Mean
1350171|NCT01795859|Secondary|Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12|Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline, 12 weeks|The modified intent to treat (mITT) population will include all subjects in the ITT population who were randomized to treatment and received study drug. For subjects with missing value at Week 12, the last available assessment was used|||units on a scale||Standard Deviation|Mean
1350172|NCT01795859|Secondary|Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)|A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.|12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post-baseline assessment.|||Participants|||Count of Participants
1350173|NCT01795859|Secondary|Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)|A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved|12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post baseline assessment.|||Participants|||Count of Participants
1350174|NCT01795859|Primary|Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12|Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea|Screening, Day 0, Weeks 9, 12|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects who missed both Week 9 or Week 12 scores, the last available assessment was used|||Units on a scale||Standard Deviation|Least Squares Mean
1350175|NCT01795716|Primary|Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose||predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose||||mcg*hr/mL||Standard Deviation|Mean
1350176|NCT01795547|Secondary|Change From Baseline to Week 28 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350177|NCT01795547|Secondary|Change From Baseline to Week 28 in SWN-S Total Score|The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350187|NCT01795495|Primary|Intra- and Post-operative Pain Relief|To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.|Intra-operative and 24 hours post-operatively||||mg/kg||Standard Deviation|Mean
1350178|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350179|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350180|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350181|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350182|NCT01795547|Secondary|Change From Baseline to Week 28 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350183|NCT01795547|Secondary|Investigator’s Assessment Questionnaire (IAQ) Total Score at Week 28|The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).|Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 4, 8, 16, and 28. Since the IAQ was assessed from week 4, the analysis was based on 133 and 131 patients|||units on a scale||Standard Error|Least Squares Mean
1350184|NCT01795547|Primary|Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
1350188|NCT01794949|Primary|Percent Stent Coverage|Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.|6 months|Participants included in the analyses for this outcome are those who completed the 6 month follow-up imaging to assess vascular healing. Optical frequency domain imaging (OFDI) was not performed on two participants in the non-diabetic study arm.|||Participants|||Count of Participants
1350189|NCT01794936|Primary|Prevalence of Intra-operative Complications|Investigators will evaluate whether any intra-operative complications resulted from the use of the VTI probe to assess safety. Specifically, this time frame is limited from the induction of anesthesia through the completion of the surgical procedure (typically ~2-3 hours)|During surgical procedure itself (~2-3 hours)|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.||||||
1350190|NCT01794936|Primary|Change in SHIM Score (Score of Erectile Function) Following Surgery|Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.|8 months post-operative follow-up|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.||||||
1350191|NCT01794845|Secondary|Estimated Overall Survival (OS)|Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).|Up to 6 years|At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Overall survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.||||||
1350192|NCT01794845|Secondary|Estimated Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.|Up to 6 years|At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Progression-free survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.||||||
1350193|NCT01794845|Secondary|Number of Study Participants Experiencing Treatment-Related Toxicity|"Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:~Acute toxicity is defined as toxicity occurring within 90 days of start of therapy.~Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy."|Up to 6 years|Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.|||Participants|||Count of Participants
1350194|NCT01794845|Primary|Overall Response Rate (ORR) of Participants|ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.|Up to 6 months from End of Treatment, about 9 months|Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.|||percentage of participants|||Number
1350195|NCT01794806|Secondary|Changes in Apico-coronal Ridge Dimension|Linear ridge height change at the mid-facial aspect of the ridge|Week 14 after tooth extraction||||millimeters||Inter-Quartile Range|Median
1350196|NCT01794806|Secondary|Changes in Bucco-lingual Ridge Dimension|Linear ridge width change at the bone crest|Baseline to Week 14 after tooth extraction||||millimeters||95% Confidence Interval|Mean
1350197|NCT01794806|Primary|Alveolar Ridge Volumetric Changes|3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups|Baseline to Week 14 after tooth extraction||||percentage of volume change||Standard Deviation|Mean
1350198|NCT01794741|Primary|Adverse Events Report|reports of treatment emergent adverse events|3 months of treatment||||event|||Number
1350199|NCT01794455|Secondary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 2 candesartan arm.|Change from week 8 to week 20|MRI data could not be obtained on the one study participant due to MRI contraindications.||||||
1350200|NCT01794455|Secondary|Montgomery-Asberg Depression Rating Scale|MADRS is a measure of depression severity (range 0 - 60, higher scores indicate more severe depressive symptoms). This outcome applies to the candesartan Phase 2 arm.|Week 20||||units on a scale|||Number
1350201|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity (range 0 - 27, higher scores indicate more severe depressive symptoms). This applies to the candesartan Phase 2 arm.|Week 20||||units on a scale|||Number
1350202|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity. This applies to the sertraline Phase 1 arm.|Week 8|||||||
1350203|NCT01794455|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|MADRS is a measure of depression severity. This outcome applies to the sertraline Phase 1 arm.|Week 8|||||||
1350204|NCT01794455|Primary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 1 sertraline arm.|Change in perfusion from baseline to week 8|Could not complete MRI.||||||
1352746|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1350205|NCT01794039|Secondary|Time to Progression|The distribution of time to progression will be estimated using the method of Kaplan-Meier. The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.|Time from registration to the earliest date with documentation of disease progression, assessed up to 2 years|All patients that received Arm A or Arm B treatment.|||Months||95% Confidence Interval|Median
1350206|NCT01794039|Secondary|Overall Survival|The distribution of survival time will be estimated using the method of Kaplan-Meier. Due to an early closer from slow accrual the data from both arms was combined in survival analysis.|Time from registration to death due to any cause, assessed up to 2 years|All patients that received Arm A or Arm B treatment.|||Months||95% Confidence Interval|Median
1350207|NCT01794039|Secondary|Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report.|Up to 30 days after last day of study drug treatment|All treated patients are evaluable for Adverse Events|||Participants|||Count of Participants
1350208|NCT01794039|Primary|Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations|The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.|Up to 2 years|All patients that received treatment were evaluable for response|||proportion of participants||95% Confidence Interval|Number
1350209|NCT01794000|Secondary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention|Medical intervention was defined as any medical evaluation resulting in therapy or further investigation, as determined by a trained medical professional. Data collected from the first dose of study medication through 10 days after last dose of study medication during the double blind study period are presented below.|First Dose through 24 Months|All randomized participants who received at least one dose of drug.|||Percentage of Participants|||Number
1350210|NCT01794000|Secondary|Time From Randomization to First and Second VOC|Data collected through the primary completion date are presented below.|Randomization to First VOC and Second VOC respectively (up to 24 Months)|All randomized participants.|||Days||95% Confidence Interval|Median
1350211|NCT01794000|Secondary|Number of Days Hospitalized for VOC|The total length of hospitalization in days for VOC was calculated for each participant. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants who were hospitalized for VOC.|||Days||Standard Error|Least Squares Mean
1350212|NCT01794000|Secondary|Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke||Randomization through 24 Months|No participants had a TIA or ischemic stroke at time of analysis.||||||
1350213|NCT01794000|Secondary|Quarterly Rate of School Absence Due to Sickle Cell Pain|Quarterly rate of school absence due to sickle cell pain was measured through participant diaries and was calculated for each participant by summing the number of days with school absence due to sickle cell pain divided by the number of school dates in the quarter. A quarter was defined as 12 weeks. The quarterly rate was set to missing if there were more than 6 weeks of missing diary entries during a specific quarter. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All Randomized participants who are 4 years or older and have both baseline and at least one post-baseline quarterly outcome measure in any quarter. Diaries were only provided to participants 4 years and older.|||Percentage of Days in a Quarter||Standard Error|Least Squares Mean
1350214|NCT01794000|Secondary|Monthly Rate of Days of Analgesic Use|Monthly rate of days of analgesic use was measured through participant diaries and was calculated for each participant by summing the number of days they reported analgesic use divided by the number of diary entries completed in the month. A month was defined as 4 weeks (28 days). The monthly rate was set to missing if there were more than 14 missing entries for analgesic use in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 4 years or older and have baseline and at least one post-baseline monthly outcome measure in any month. Diaries were only provided to participants 4 years and older.|||Percentage of Days in a Month||Standard Error|Least Squares Mean
1350215|NCT01794000|Secondary|Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions)|RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
1350216|NCT01794000|Secondary|Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome)|Acute chest syndrome was defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Acute chest syndrome that occurred within 7 days of the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
1350217|NCT01794000|Secondary|Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations)|Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
1350231|NCT01793935|Secondary|Immune Marker IL-6|Changes in immune marker IL-6 will be assessed in response to study medication.|Changes from Baseline in Immune markers at 12 weeks or end of study|"The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for IL-6."|||pg/mL||Standard Deviation|Mean
1350218|NCT01794000|Secondary|Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis)|A painful crisis is defined as an onset of moderate to severe pain that lasts at least 2 hours for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, ketorolac, or other analgesics prescribed by a health care provider (HCP) in a medical setting such as a hospital, clinic, emergency room visit, or telephone management. The painful crisis that occurred within 7 days from the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
1350219|NCT01794000|Secondary|Monthly Mean in Faces Pain Scale-Revised Score|Each day participants selected the face on the FPS-R scale that reflected their worst pain related to sickle cell disease (SCD) on that day. Monthly mean in FPS-R score was calculated for each participant by summing the FPS-R score divided by the number of non-missing diary entries completed in the month. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. A month was defined as 4 weeks (28 days). The monthly mean in FPS-R score was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.|||Units on a Scale||Standard Error|Least Squares Mean
1350220|NCT01794000|Secondary|Monthly Rate of Days With Pain|Monthly rate of days with pain was measured through participant diaries using a modified version of the Faces Pain Scale-Revised (FPS-R). Each day participants selected the face on the scale that reflected their worst pain related to sickle cell disease (SCD) on that day. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. Any day the participant selected a face other than face 0 was considered a day with pain. Monthly rate of days with pain was calculated for each participant by summing the number of days reported with any pain divided by the number of non-missing diary entries completed in the month. A month was defined as 4 weeks (28 days).The monthly rate was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are present below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.|||Percentage of Days in a Month||Standard Error|Least Squares Mean
1350221|NCT01794000|Primary|Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC)|The VOC is a composite endpoint of painful crisis or acute chest syndrome. Events that occurred within 7 days from the prior event onset date were not counted as a new episode. Data collected through the primary completion date reported below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
1350222|NCT01793935|Other Pre-specified|Laboratory Analytes|"Changes in laboratory analytes will be classified as normal or abnormal (example: white blood cell counts)"|Change from Baseline in Laboratory Analytes at 12 weeks or end of study|||||||
1350223|NCT01793935|Other Pre-specified|Vital Signs - Temperature|"Clinically significant changes in Temperature will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||degrees F||Standard Deviation|Mean
1350224|NCT01793935|Other Pre-specified|Vital Signs - Pulse|"Clinically significant changes in Pulse will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||beats/min||Standard Deviation|Mean
1350225|NCT01793935|Other Pre-specified|Vital Signs - Blood Pressure Systolic and Diastolic|"Clinically significant changes in BP will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||mm/Hg||Standard Deviation|Mean
1350226|NCT01793935|Other Pre-specified|Vital Signs - Body Mass Index|"Clinically significant changes in BMI will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||kg/m^2||Standard Deviation|Mean
1350227|NCT01793935|Other Pre-specified|Vital Signs - Weight|"Clinically significant changes in weight will be assessed for normal or abnormal following randomization to 12 weeks or end of study"|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||lbs||Standard Deviation|Mean
1350228|NCT01793935|Secondary|Immune Marker S-100B|"Changes in immune marker S-100B will be assessed in response to study medication.~Elisa~Sensitivity 2.7 picogm/ml~Range 2.7 to 2000 picogm/ml"|Baseline and 12 weeks or end of treatment|"The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for S-100B."|||pg/mL||Standard Deviation|Mean
1350229|NCT01793935|Secondary|Immune Marker Hs-CRP (High Sensitivity C Reactive Protein)|"Changes in immune marker hs-CRP (high sensitivity C Reactive Protein) will be assessed in response to study medication.~hsCRP - mg/L"|Baseline and 12 weeks or end of study|"The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for hs-CRP."|||mg/L||Standard Deviation|Mean
1350230|NCT01793935|Secondary|Immune Marker IFN-Y (Gamma)|Changes in immune marker IFN-Y (gamma) will be assessed in response to study medication.|Baseline and 12 weeks or end of study|data cannot be summarized IFN-Y (gamma) levels undetectable|||pg/mL||Standard Deviation|Mean
1350234|NCT01793935|Secondary|Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale|"The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: Possible ratings are: 1= Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5= Minimally worse, 6= Much worse, 7=Very much worse.~The higher the score the worse outcome"|12 weeks|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||Participants|||Count of Participants
1350235|NCT01793935|Secondary|Clinical Global Impression Scale (CGI-S) - Severity|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 0 = not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients – The higher the score the worse outcome|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||units on a scale||Standard Deviation|Mean
1350236|NCT01793935|Secondary|Perceived Stress Scale (PSS)|"The Perceived Stress Scale (PSS) was developed to measure the degree to which situations in one’s life are appraised as stressful.~Perceived Stress Scale Scoring Each item is rated on a 5-point scale ranging from never (0) to very often (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.~PSS-10 scores are obtained by reversing the scores on the four positive items:~For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Total score can range from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress,"|Baseline and 12 weeks or end of treatment|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||units on a scale||Standard Deviation|Mean
1350237|NCT01793935|Primary|Positive and Negative Syndrome Scale (PANSS)|"The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms.~PANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) – Higher values represent a worse outcome.~PANSS Negative subscale consists of 7 Items - (minimum score = 7, maximum score = 49) – Higher values represent a worse outcome.~General Psychopathology subscale consists of 16 items - (minimum score = 16, maximum score = 112) – Higher values represent a worse outcome.~PANSS Total Score - The 3 subscales scores are summed to compute a PANSS Total score. The minimum PANSS total score = 30, maximum = 210 – Higher values represent a worse outcome"|Baseline and 12 Weeks|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||units on a scale||Standard Deviation|Mean
1350238|NCT01793883|Primary|Time to Alleviation of Influenza Symptoms|Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.|Efficacy will be assessed over 14 days post-randomization.|Intent-to-treat-infected (ITT-I) population - all ITT subjects with laboratory confirmed influenza A or B infection by at least one virological method (qRT-PCR or qCulture) on either Day 1 or 3|||hours||95% Confidence Interval|Median
1350239|NCT01793688|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.|||Participants|||Number
1350240|NCT01793688|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.|||Participants|||Number
1350241|NCT01793688|Primary|Clinical Effectiveness Rate by Indication|Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of participants with assessable effectiveness evaluation, was presented by each indication (pneumonia, lung abcess and peritorinitis) along with the corresponding exact 2-sided 95% confidence interval. Overall effectiveness of sulbactam sodium/ampicillin sodium was determined by the investigator based on clinical symptoms and examinations at the end of high-dose (>6 g daily) treatment. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at the end of treatment.|14 Days|The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once.|||Percentage of participants||95% Confidence Interval|Number
1350242|NCT01793688|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.|||Participants|||Number
1350243|NCT01793285|Secondary|Time to Treatment Discontinuation With Etanercept|Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept.|Year 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||years||95% Confidence Interval|Mean
1350244|NCT01793285|Secondary|Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels|Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs).|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for each parameter at specified time point.|||milligram per deciliter (mg/dL)||Inter-Quartile Range|Median
1350245|NCT01793285|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||mm/hr||Inter-Quartile Range|Median
1350246|NCT01793285|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||milligram per milliliter (mg/mL)||Inter-Quartile Range|Median
1350247|NCT01793285|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm (rounded to the nearest 0.1 cm), is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||cm||Inter-Quartile Range|Median
1350248|NCT01793285|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||cm||Inter-Quartile Range|Median
1350249|NCT01793285|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||cm||Inter-Quartile Range|Median
1350250|NCT01793285|Secondary|Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|Participant’s fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: “How would you describe the overall level of fatigue/tiredness you have experienced?” 0=none and 10=very severe.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
1350251|NCT01793285|Secondary|Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|Participant’s spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: “How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had?” 0 =none and 10 =very severe.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
1350252|NCT01793285|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10, 0=none and 10=very severe participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
1350253|NCT01793285|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
1350254|NCT01793285|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||mm||Inter-Quartile Range|Median
1350255|NCT01793285|Secondary|Number of Participants Who Received Pharmacological Treatment|Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs [NSAIDs], disease-modifying antirheumatic drugs [DMARDs], corticosteroids and other treatments including anti-tumor necrosis factor-alpha [TNFalpha] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||participants|||Number
1350256|NCT01793285|Secondary|Number of Participants Who Received Non-pharmacological Treatment|Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||participants|||Number
1350257|NCT01793285|Secondary|Time to Diagnosis of Ankylosing Spondylitis|Time to first diagnosis of alkylosing spondylitis was reported.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||years||Standard Deviation|Mean
1350258|NCT01793285|Secondary|Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist|Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||years||Standard Deviation|Mean
1350259|NCT01793285|Primary|Percentage of Participants Who Discontinued Treatment With Etanercept|Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||percentage of participants|||Number
1350260|NCT01792986|Secondary|Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.||6 weeks||||trillion cells/L||Standard Deviation|Mean
1350261|NCT01792986|Secondary|Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.||6 weeks||||ng/mL||Standard Deviation|Mean
1350262|NCT01792986|Secondary|Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.||6 weeks||||mg/dL||Standard Deviation|Mean
1350263|NCT01792986|Secondary|Difference in Weight Between Baseline and the End of the Sixth Week||6 weeks||||kg||Standard Deviation|Mean
1350264|NCT01792986|Primary|Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.||6 weeks||||mg/dL||Standard Deviation|Mean
1350265|NCT01792830|Secondary|Number of Participants Experiencing a Hyperglycemic Event|The number of participants that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl.|3 months after discharge|Participants who completed the Month 3 study visit, in person or by phone.|||Participants|||Count of Participants
1350266|NCT01792830|Secondary|The Number of Participants Experiencing a Severe Hypoglycemic Event|The number of participants that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl.|3 months after discharge|Participants who completed the Month 3 study visit in person or by phone.|||Participants|||Count of Participants
1350267|NCT01792830|Secondary|The Number of Participants Experiencing a Hypoglycemic Event|The number of participants that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl.|3 months after discharge|This analysis includes participants who completed the month 3 study visit either in person or by phone.|||Participants|||Count of Participants
1350268|NCT01792830|Secondary|Number of Participants Readmitted to the Hospital|The number of participants that were readmitted to the hospital 3 months after initial hospital discharge|3 months after discharge|This analysis includes participants who completed the month 3 study visit either in person or by phone.|||participants|||Number
1350269|NCT01792830|Primary|Efficacy, Measured by a Change in HbA1c Levels|Change in the level of HbA1c in a one month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.|One month after hospital discharge|"This analysis includes participants who had blood drawn one month after hospital discharge. Most patients that completed the discharge part did so over the phone. The diabetic, HbA1C <7%, metformin and insulin glargine is not included in this table as no participants in this group had blood drawn for this analysis."|||percent of glycosylated hemoglobin||Standard Deviation|Mean
1350899|NCT01785186|Secondary|Changes in Baseline Laboratory Safety Parameters During Treatment and Follow-up|Frequency tables will be generated for visual acuity tests, 12 lead ECGs, clinical chemistry metrics, haematology, and urinalysis|0 - 12 weeks|||||||
1350270|NCT01792817|Secondary|Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events.|The primary safety measure for this study is the incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events during Phase 1 of the study.|4 weeks, Phase 1||||Serious Adverse Events|||Number
1350271|NCT01792817|Secondary|Average Mean Attack Intensities Experienced Per Subject|Cluster headache attack intensity was reported on a 5-point scale: no pain, mild, moderate, severe, very severe, whereas no pain =1 is the best outcome and very severe=5 is the worst outcome . The average of all subjects’ mean attack intensities experienced at 15 minutes post-initiation of treatment during Phase 1 for the active treatment group, compared to the sham control group. The mean 15-minute scores were calculated for the first five attacks suffered by each subject during Phase 1. For subjects with fewer than five treated attacks, the scores for those available were averaged.|15 minutes post-stimulation|There were 4 subjects with no data in the Sham GammaCore group and 13 subject in the GammaCore group.|||Score on a scale||Standard Deviation|Mean
1350272|NCT01792817|Secondary|Sustained Treatment Success at 1 Hour Post-Treatment|Sustained treatment success at 1 hour post-treatment was defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale at 15 minutes and 1 hour post-initiation of treatment of the first treated cluster headache attack of Phase 1, and having refrained from use of rescue medications during the full 60 minute period|For 1 hour post stimulation||||Participants|||Count of Participants
1350273|NCT01792817|Primary|Number of Participants With Repsonse to Treatment|"The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group.~A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1."|15 minutes post stimulation|Intent to treat study population|||Participants|||Count of Participants
1350274|NCT01792635|Secondary|Ra in Part B in PF-05175157 200 mg BID Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
1350275|NCT01792635|Secondary|Ra in Part B in Placebo Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
1350276|NCT01792635|Secondary|EGP in Part B in PF-05175157 200 mg BID Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg fat free mass (FFM)/min||Full Range|Median
1350277|NCT01792635|Secondary|EGP in Part B in Placebo Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg fat free mass (FFM)/min||Full Range|Median
1350278|NCT01792635|Secondary|GIR in Part B in PF-05175157 200 mg BID Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/min||Full Range|Mean
1350279|NCT01792635|Secondary|GIR in Part B in Placebo Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/min||Full Range|Mean
1350280|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B|Criteria for PCI changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) and increase of >=25% from baseline when baseline >200 msec or increase of >=50% when baseline less than or equal to (<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) >=140 msec and increase of >=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to < 480 msec and >=480 msec, or an increase from baseline of 30 to <60 msec or >=60 msec.|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5.|||Participants|||Number
1350281|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B|Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (>=)30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or greater than (>) 120 beats per minute (bpm).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5|||Participants|||Number
1350317|NCT01791972|Secondary|Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%|Participants were classified as unprotected if the maximum percentage decrease from baseline FEV1 after exercise was more than 20%. Data represents the number of participants who were classified as unprotected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set|||participants|||Number
1350282|NCT01792635|Primary|Number of Participants With Laboratory Test Abnormalities in Part B|Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], urine drug screen, lipid profile and very-low-density lipoproteins [VLDL], hemoglobin A1c [HbA1c], C-peptide, thyroid-stimulating hormone [TSH], Hepatitis B and C, human immunodeficiency virus [HIV], triglycerides, urine creatinine).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the Clinical Research Unit (CRU) on Day -5|||Participants|||Number
1350283|NCT01792635|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the clinical research unit (CRU) on Day -5|||Participants|||Number
1350284|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
1350285|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in Placebo Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
1350286|NCT01792635|Primary|Whole-body Glucose Uptake in Part A|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.|||mg/kg BW/min||90% Confidence Interval|Mean
1350287|NCT01792635|Primary|Rate of Appearance of Glucose (Ra) in Part A|Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.|||mg/kg BW/min||Full Range|Mean
1350288|NCT01792635|Primary|[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A|[6,6-2H2] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp|||percentage enrichment of plasma glucose||90% Confidence Interval|Mean
1350289|NCT01792635|Primary|Endogenous Gucose Production (EGP) in Part A|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp|||mg/kilogram (kg) body weight (BW)/min||Full Range|Median
1350290|NCT01792635|Primary|Glucose Infusion Rates (GIR) in Part A|GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp|||mg/min||90% Confidence Interval|Mean
1350291|NCT01792518|Secondary|The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment|The change from baseline in estimated glomerular filtration rate (eGFR) as assessed by chronic kidney disease epidemiology collaboration (CKD-EPI) equation (cystatin C) after 24 weeks of treatment. The term “baseline” refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest. This outcome measure is a secondary safety endpoint.|Baseline and 24 weeks|Treated Set|||milliliter/minute/1.73 square metre||Standard Error|Least Squares Mean
1350292|NCT01792518|Secondary|The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment|"The time weighted average of percentage change from baseline in UACR (mg/g creatinine) during the course of 24 weeks of treatment. The term baseline for UACR refers to the geometric mean of UACR values measured at Visits 2 and 3. The number of participants analysed displays the number of participants with available data at the timepoint of interest. The Least Squares Means are adjusted geometric means."|Baseline and 24 weeks|Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Last Observation Carried Forward (LOCF).|||mg/g creatinine||95% Confidence Interval|Least Squares Mean
1352747|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1350293|NCT01792518|Primary|HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment|Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double- blind trial medication. The term “baseline” refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 24 weeks|Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Observed Case (OC): Values after the use of rescue medication were set to missing.|||Percentage of HbA1c||Standard Error|Least Squares Mean
1350294|NCT01792284|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at 12 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.|||percentage of participants|||Number
1350295|NCT01792284|Secondary|Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)|LS means were calculated using MMRM analysis including visit and baseline lipid level (last nonmissing value at or before the beginning of Lead-in) as covariates.|Day 1 of Lead-In Period, 36 Weeks|All enrolled participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable lipid data.|||mg/dL||Standard Error|Least Squares Mean
1350296|NCT01792284|Secondary|0300-Hour Blood Glucose to Fasting Blood Glucose Excursion|Excursion results were calculated by subtracting the 0300 hours glucose value from the next day pre-morning glucose value within a single SMBG profile. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline 0300-hour to next day pre-breakfast excursion (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG excursion data.|||mg/dL||Standard Error|Least Squares Mean
1350297|NCT01792284|Secondary|Proportion of Bolus to Total Insulin Doses at 12 Weeks|Proportion of bolus to total insulin dose is presented, where LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline proportion of bolus to total insulin dose (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable bolus to total insulin dose data.|||units/day||Standard Error|Least Squares Mean
1350298|NCT01792284|Secondary|Basal, Bolus, and Total Insulin Doses at 12 Weeks|LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline insulin dose (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable insulin dose data.|||units/kg/day||Standard Error|Least Squares Mean
1350299|NCT01792284|Secondary|Participants With Treatment-Emergent Anti-LY2605541 Antibody Response|The number of participants with a treatment emergent anti-LY2605541 antibody response (TEAR) is presented. Positive TEAR was defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from 1) undetectable to detectable or from 2) detectable to the value with at least 130% relative increase from baseline.|Day 1 of Lead-in Period through 36 Weeks|Participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable anti-LY2605541 antibody data.|||participants|||Number
1350300|NCT01792284|Secondary|Change From Randomization to 12 Weeks in HbA1c|LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|Randomization, 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1350301|NCT01792284|Secondary|Change From Day 1 of Lead-In Period to 36 Weeks in Body Weight|LS means were calculated using MMRM analysis, including visit and baseline weight (last non-missing value at or before the beginning of Lead-in Period) as covariates.|Day 1 of Lead-In Period, 36 Weeks|All enrolled participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable body weight data.|||kg||Standard Error|Least Squares Mean
1350302|NCT01792284|Secondary|Change From Randomization to 12 Weeks in Body Weight|LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline body weight (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|Randomization, 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
1350303|NCT01792284|Secondary|Intra-participant Variability in SMBG at 12 Weeks|A summary of glucose variability (intra-participant variability) as measured by the average of between-day standard deviations of individual SMBG time points. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG variability data.|||mg/dL||Standard Error|Least Squares Mean
1350460|NCT01790828|Secondary|Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy|Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy.|4 years|Data were not analyzed as no participants experienced rating of 'no response'.||||||
1350304|NCT01792284|Secondary|Self-Monitored Blood Glucose (SMBG) at 12 Weeks|SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
1350305|NCT01792284|Secondary|Change From Randomization to 12 Weeks in 9-Point SMBG|SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|Randomization, 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
1350306|NCT01792284|Secondary|Fasting Serum Glucose (FSG) at 12 Weeks|LS means for FSG (obtained from clinical laboratory tests) were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FSG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FSG data.|||mg/dL||Standard Error|Least Squares Mean
1350307|NCT01792284|Secondary|Intra-Participant Variability of FBG at 12 Weeks|FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in FBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FBG data.|||mg/dL||Standard Error|Least Squares Mean
1350308|NCT01792284|Secondary|Fasting Blood Glucose (FBG) Measured by Self-Monitored Blood Glucose|FBG was measured by self-monitored blood glucose (SMBG). LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FBG data.|||mg/dL||Standard Error|Least Squares Mean
1350309|NCT01792284|Secondary|Percentage of Participants With Total and Nocturnal Hypoglycemic Events|Total HE include any event based on a blood glucose <=70 mg/dL (3.9 mmol/L), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline (Day 1) of Randomization Period through 24 weeks (12 weeks in each Randomization Period)|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HE data during Randomization Periods|||percentage of participants|||Number
1350310|NCT01792284|Secondary|30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events|Total hypoglycemic events (HE) include any event based on a blood glucose <=70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. Group Means are presented and were calculated from negative binomial regression models (number of episodes = treatment + period + treatment sequence + baseline HbA1c [<=8.0% or >8.0%], with log [exposure in days/30] as an offset variable). Group Mean (LS mean) is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline (Day 1) of Randomization Period through 24 Weeks (12 weeks in each Randomization Period)|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HE data during Randomization Periods.|||events/participant/30 days||Standard Error|Least Squares Mean
1350311|NCT01792284|Primary|Hemoglobin A1c (HbA1c) at 12 Weeks|HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1350312|NCT01792024|Secondary|Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)|Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.|At 1,3 and 12 months||||units on a scale||Full Range|Median
1350313|NCT01792024|Secondary|Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)|International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.|At 1,3 and 12 months||||units on a scale||Full Range|Median
1350900|NCT01785186|Secondary|Occurence of Treatment Failure (Relapse or Emergence of Drug-resistance)|Frequency of treatment failures (number of patients with relapse and/or development of drug resistance) will be recorded|0 - 12 weeks|||||||
1350318|NCT01791972|Secondary|Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%|Participants were classified as protected if the maximum percentage decrease from baseline FEV1 after exercise was less than 10%. Data represents the percentage of participants who were classified as protected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set|||percentage of participants|||Number
1350319|NCT01791972|Primary|Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge|"A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center.~The percentage fall was defined as 100*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge.~The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant’s heart rate to ≥80% of the maximum rate for age (220 bpm–age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges."|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set|||percentage change from baseline FEV1||Standard Error|Mean
1350320|NCT01791894|Secondary|Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Baseline to cycle 3||||number of occurrences|||Number
1350321|NCT01791894|Secondary|Patients With Progressive Disease Post Treatment by RECIST Criteria|Patients with a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|After 3 treatment cycles (approx. 61 days)||||participants|||Number
1350322|NCT01791894|Secondary|Patients With Stable Disease Post Treatment|Number of patients with stable disease post treatment by RECIST criteria|After 3 cycles of treatment (approx. 61 days)|4 patients completed 3 cycles of treatment|||participants|||Number
1350323|NCT01791894|Primary|Percent Change in Biomarker (GLI2 Protein) Levels||baseline to day 33|We recruited patients with biopsy-confirmed metastatic basal cell carcinoma who were had progressed on SMO inhibitors such as vismodegib (GDC 0449), IPI- 926, LEQ506 and LDE225.|||percentage decrease||Standard Deviation|Mean
1350324|NCT01791803|Secondary|Smoking Abstinence Rate at 12 and 26 Weeks|Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.|12 weeks and 26 weeks after hospital discharge|Abstinence comparing the 2 admitting diagnoses was similar within each arm, thus analysis for admitting diagnosis was done combining the 4 arms.|||percentage of smoking abstinence rate|||Number
1350325|NCT01791803|Secondary|Smoking Cessation|Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers.|at 12 weeks after hospitalization||||Participants|||Count of Participants
1350326|NCT01791803|Primary|Abstinence From Smoking|Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers.|at 26 weeks after hospitalization||||percentage of participants|||Number
1350327|NCT01791725|Other Pre-specified|Improvement in NPI Total Scores in Subjects With NPI Score ≥1 at Baseline Baseline|The Neuropsychiatric Inventory(NPI) (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia patients. The NPI was administered at the Baseline Visit (Day 1) and at Day 28 (EOS) or ET. A decrease in score shows an improvement in symptoms.|Baseline and 4 weeks|Subjects with NPI Score ≥1 at baseline|||participants|||Number
1350328|NCT01791725|Other Pre-specified|Cognitive Outcome (RADD Total Score)|Rapid Assessment for Development Disabilities (RADD) The RADD test was developed from the low-difficulty items from published intelligence tests (Walsh et al 2007). It was specifically developed for evaluation of individuals with intellectual disabilities and developmental disabilities. It is a validated and reliable cognitive screening instrument that can be rapidly administered. The RADD is composed of 76 items. Each item is scored as 0 (incorrect) or 1 (correct).The test assesses a wide range of functional abilities including receptive and expressive language, orientation, registration, recall, attention, self identification, motor skills, imitation, abstract reasoning, number skills, comprehension and short-term memory to give a total score. Scores are from 0 to 76. A higher total score is correlated with a higher Cognitive Impairment level.|Baseline and 4 Weeks||||units on a scale||Standard Deviation|Mean
1350329|NCT01791725|Other Pre-specified|Pharmacokinetic Assessment|Mean Plasma ELND005 Concentrations- Cmax|Baseline and 4 Weeks||||μg/mL||Standard Deviation|Mean
1350330|NCT01791725|Other Pre-specified|Changes From Baseline in Abnormal Neurological Examination Results|Subjects with Abnormal Neurological Examination Results|Baseline and 4 weeks||||participants|||Number
1350331|NCT01791725|Primary|Incidence of Adverse Events (TEAEs)|For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC.|4 weeks||||participants|||Number
1350332|NCT01791517|Primary|Overall Comfort Score (Etafilcon A Lens)|CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|2-Week Follow-up|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.|||units on a scale||Standard Deviation|Mean
1350333|NCT01791517|Primary|Overall Comfort Score (Galyfilcon A Lens)|CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|2-Week Follow-up|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.|||units on a scale||Standard Deviation|Mean
1350334|NCT01791517|Primary|Overall Comfort Score (Senofilcon A Lens)|CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|2-Week Follow-up|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.|||units on a scale||Standard Deviation|Mean
1350335|NCT01791491|Secondary|Percentage of CD86 Receptor Occupancy|Blood samples collected following the single dose belatacept infusion were assessed for CD86 receptor occupancy (CD86 RO).|0.5 hours post dose on Day 1, Day 29 and Day 57|Pharmacodynamic analysis set: all participants who received one dose of belatacept and who had at least 1 pharmacodynamic result (CD86 RO) reported after that dose.|||percent||Standard Deviation|Mean
1350336|NCT01791491|Secondary|Number of Participants With Positive Belatacept-induced Immunogenicity Response|Serum samples were analyzed for anti-belatacept antibodies using a validated homogenous bridging assay. The assay followed a tiered approach consistent with health authority guidance: tier 1 for screening ADA responses, tier 2 for confirming drug specificity of the ADA-positive responses, and tier 3 for titer. A neutralizing antibody assay was used to test those samples positive to the LEA29Y portion of the molecule in tier 2 and for which drug concentrations are =>1 μg/mL. Lack of immunogenicity was defined as the absence of a positive response.|Baseline/Day 1, Days 15, 29, and 57|All treated participants who received at least one dose of belatacept.|||participants|||Number
1350337|NCT01791491|Primary|Volume of Distribution at Steady-state (Vss) of Belatacept|"Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Vss was measured in liters per kg body weight (L/kg)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||Liters per kilogram||Geometric Coefficient of Variation|Geometric Mean
1350338|NCT01791491|Primary|Total Body Clearance (CLT) of Belatacept|"CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||milliliters per hours per kilogram||Geometric Coefficient of Variation|Geometric Mean
1350339|NCT01791491|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0-T)) and Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Belatacept|"AUC (0 - T) and AUC (0 - INF) were derived from serum concentration versus time data and measured in microgram hours per milliliter (µg*h/mL). Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||microgram hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
1350340|NCT01791491|Primary|Half-Life of Elimination (T-Half) of Belatacept|"T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). T-HALF was measured in hours (h)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belataceptand who had at least 1 blood sample drawn for PK determination.|||hours||Standard Deviation|Mean
1350341|NCT01791491|Primary|Time of Maximum Observed Plasma Concentration (Tmax) of Belatacept|"Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Tmax was measured in hours (h)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||hours||Full Range|Median
1350342|NCT01791491|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|"Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Cmax was measured in micrograms per milliliter."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1350343|NCT01791491|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), and Treatment-related Adverse Event (AE)|Death was a fatal event leading to permanent cessations of all vital functions of the body. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment related=having certain, probable, possible, or missing relationship to study drug.|Date of First Dose to 24 weeks post the last dose; approximately 26 weeks|All treated participants who received at least one dose of belatacept.|||participants|||Number
1350344|NCT01791465|Secondary|Waist to Hip Ratio at Baseline and 16 Weeks||baseline and 16 weeks||||ratio||Inter-Quartile Range|Mean
1350345|NCT01791465|Secondary|Hip Circumference at Baseline and 16 Weeks||baseline and 16 weeks||||centimeters||Inter-Quartile Range|Mean
1350346|NCT01791465|Secondary|Waist Circumference at Baseline and 16 Weeks||baseline and 16 weeks||||centimeters||Inter-Quartile Range|Mean
1350347|NCT01791465|Secondary|Body Weight at Baseline and 16 Weeks||baseline and 16 weeks||||kilograms||Inter-Quartile Range|Mean
1350348|NCT01791465|Other Pre-specified|Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks|Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51|baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Mean
1350349|NCT01791465|Secondary|Serum LDL Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
1350350|NCT01791465|Secondary|Serum HDL Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
1350351|NCT01791465|Secondary|Serum Total Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
1350352|NCT01791465|Secondary|Serum Triglycerides Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
1350353|NCT01791465|Secondary|Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||percentage of glycated haemoglobin||Inter-Quartile Range|Mean
1350354|NCT01791465|Secondary|Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
1350355|NCT01791465|Secondary|Serum Soluble CD14 Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
1350356|NCT01791465|Secondary|Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
1350357|NCT01791465|Secondary|Body Mass Index at Baseline and 16 Weeks||16 weeks||||kg/m2||Inter-Quartile Range|Mean
1350358|NCT01791465|Secondary|Serum Adipokine Leptin Levels at Baseline and 16 Weeks||baseline and 16 weeks||||ng/ml||Inter-Quartile Range|Mean
1350359|NCT01791465|Secondary|Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks|The Oral Glucose Insulin Sensitivity (OGIS) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. OGIS values for glucose clearance are reported in units of ml/min per square meter of body surface area. Lower values indicate slower glucose clearance and higher insulin resistance.|baseline and 16 weeks||||ml/min/m^2 BSA||Inter-Quartile Range|Mean
1350360|NCT01791465|Secondary|Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
1350361|NCT01791465|Secondary|Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
1350362|NCT01791465|Secondary|Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
1350363|NCT01791465|Primary|Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks|The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.|baseline and 16 weeks||||mg/dl||Inter-Quartile Range|Median
1350364|NCT01791465|Primary|Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks|The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.|baseline and 16 weeks|Change in hsCRP over 16 weeks of treatment|||mg/dl||Inter-Quartile Range|Median
1350365|NCT01791413|Primary|Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation||Within the first 2 weeks and 3 months after surgery||||percentage of serum AMH change||Inter-Quartile Range|Median
1350366|NCT01791244|Secondary|Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12|Subjects defined up to 4 personal lifestyle goals during the first study week. Subjects completed the following questions related to lifestyle goals achieved during this study: 1. Was the goal achieved? (Yes/No) 2. If yes, better than expected or achieved as expected? 3. If better than expected, a lot or a little better than expected? 4. If no, a little or a lot less than expected?|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, n signifies subjects who were evaluable for the specific goal in this outcome measure."|||Subjects|||Number
1350461|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age|Response categories were excellent, good, moderate, and no response.|4 years|All enrolled participants; only participants ≥18 years who receive don-demand therapy were included in the analysis.|||number of responses|Participants||Number
1350367|NCT01791244|Secondary|Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12|The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either “Very unsatisfied, unsatisfied, satisfied or very satisfied”.|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Subjects|||Number
1350368|NCT01791244|Secondary|Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12|The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either “Very discontented, discontented, contented or Very contented”.|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure."|||Subjects|||Number
1350369|NCT01791244|Secondary|Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12|Lifestyle Questionnaire was used to assess the quality of life for subjects based on following parameters: Stress, Alcohol, Cost, Physical Aspect, Sleep, Activity and Smoking. Subjects provided their responses on the basis of three color codes: Green, Orange and Red, where Green refers to – no problem; Orange refers to – some problem and red refers to – definite/debilitating problem.|Month 6 and 12|ITT population was used. Here, “Overall Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome Measure and “n” signifies those subjects who were evaluable for specified time points, respectively.|||Subjects|||Number
1350370|NCT01791244|Secondary|Percentage of Subjects With Adverse Events (AE) up to Month 12|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment Emergent Adverse Events (TEAEs) include both Serious TEAEs and non-serious TEAEs.|Baseline up to Month 12|The Safety Population included all subjects who were randomized and received at least 1 dose of trial treatment.|||Percentage of Subjects|||Number
1350371|NCT01791244|Secondary|Number of Subjects With Working Ability at Month 12|Working ability was assessed by measuring the number of subjects for the following categories: 1) Subjects with full sickness/disability pension, 2) Subjects who were employed or had their own business, 3) Subjects who were retired, 4) Subjects who were studying, 5) None of the above.|Month 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, “Overall Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.|||Subjects|||Number
1350372|NCT01791244|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12|Hospital Anxiety and Depression Scale (HADS) was used to measure depression and anxiety in patients. The scale was limited to 14 questions, a practical tool for identifying and quantifying the two most common forms psychological disturbances in medical subjects. 7 of the items relate to anxiety and 7 relate to depression. Each item on the questionnaire was scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression where higher score indicates more anxiety/depression.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
1350373|NCT01791244|Secondary|Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12|The Modified Fatigue Impact Index assesses fatigue- severity, distress, or degree of interference. Modified Fatigue Impact Scale Index was expressed in terms of percentage and ranged from 0% (no fatigue) to 100% (almost always impacted by fatigue).|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.|||Percentage of fatigue||Standard Deviation|Mean
1350374|NCT01791244|Secondary|Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12|The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always). A total score ranged from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.|Baseline, Month 6 and 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.. Here, Overall Number of subjects analyzed signifies those subjects who were evaluable for this outcome Measure."|||units on a scale||Standard Deviation|Mean
1350375|NCT01791244|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12|Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
1350403|NCT01791205|Secondary|Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy|Mean duration of previous treatment with a biologic drug in monotherapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug before monotherapy were considered for this outcome measure.|||Days||Standard Deviation|Mean
1350376|NCT01791244|Secondary|Percentage of Subjects With Treatment Adherence at Month 6 and 12|According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with <10% missed injections (measured with the software RDS 2.0) during 6 and 12 months were reported.|Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||Percentage of Subjects|||Number
1350377|NCT01791244|Secondary|Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12|EQ-5D-5L VAS was used to record a subject’s rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
1350378|NCT01791244|Secondary|Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12|Quality of life was assessed using the EQ5D-5L score, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems) in which 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. A unique EQ5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from 5 to 25. An increase in the EQ5D-5L total score indicates worsening.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
1350379|NCT01791244|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The total score of the MSIS-29 was comprised of all the 29 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Score was calculated using following formula: sum of score for 29 questions - 29/1.45. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject’s functioning.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
1350380|NCT01791244|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject’s functioning.|Baseline and Month 6|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
1350381|NCT01791244|Primary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject’s functioning.|Baseline and Month 12|The ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
1350382|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time|Serum electrophoresis parameters includes albumin, alpha-1 globulin, alpha-2 globulin, beta globulin, gamma globulin was reported. Mean change from Baseline values are reported at each time points.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Percentage of concentration||Standard Deviation|Mean
1350383|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time|Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Units/Liter||Standard Deviation|Mean
1350404|NCT01791205|Secondary|Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy|Mean dose of corticosteroids at study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received corticosteroids were considered for this outcome measure.|||milligrams||Standard Deviation|Mean
1350384|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time|Mean change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides (TG), total bilirubin, direct bilirubin, glucose, creatinine, blood urea nitrogen (BUN) levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||mg/dL||Standard Deviation|Mean
1350385|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time|Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||10^6 cells/microliter||Standard Deviation|Mean
1350386|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time|Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Percentage of cells||Standard Deviation|Mean
1350387|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time|The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||gram/dL||Standard Deviation|Mean
1350388|NCT01791205|Secondary|Phase II: Number of Side Effects That Induced Transient Interruption of Treatment|Number of side effects (AEs) that induced transient interruption of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||AEs|||Number
1350389|NCT01791205|Secondary|Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment|Number of side effects (AEs) that had not induced discontinuation of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||AEs|||Number
1350390|NCT01791205|Secondary|Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects|Number of participants who retained in therapy without interruption due to side effects is reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Participants|||Number
1350391|NCT01791205|Secondary|Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AE. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. The AE were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Participants|||Number
1350392|NCT01791205|Secondary|Phase II: Mean VAS Fatigue Score Overtime|The VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Higher score indicate worsening.|At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Scores on scale||Standard Deviation|Mean
1350393|NCT01791205|Secondary|Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18|Percentage of participants with change in HAQ (Delta HAQ) of >= 0.21 after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. The HAQ consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350394|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18|Mean Change From Baseline (day of the first infusion with tocilizumab as monotherapy) in the dose of corticosteroids after 3, 6, 12 and 18 months from Baseline is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||milligrams||Standard Deviation|Mean
1350405|NCT01791205|Secondary|Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy|The percentage of participants treated with corticosteroids at enrollment is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
1350395|NCT01791205|Secondary|Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18|The mean change from Baseline (day of the first infusion with tocilizumab as monotherapy) in the TJC And SJC after 3, 6, 12 and 18 months is reported. The TJC and SJC were determined for 28 joint counts. The scores ranged from 0 (no disease activity) to 28 (higher/worsen disease activity), where higher scores represents higher disease activity.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Joints||Standard Deviation|Mean
1350396|NCT01791205|Secondary|Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18|Percentage of participant achieving SDAI remission (< 3.3), after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy is reported. The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA which (based on 0-10 cm VAS, 0 = no disease activity and 10 = worst disease activity, where higher scores represent higher disease activity), and CRP. The SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350397|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18|Percentage of participants achieving CDAI remission < 2.8, after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. CDAI is the numerical sum of four outcome parameters: TJC, SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350398|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 ESR < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350399|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC (28 joints) + 0.28 square root of SJC (28 joints) + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 CRP < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350400|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained delta DAS28 ESR of >= 0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); where decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350401|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained the change in DAS28 (Delta DAS28) CRP of >=0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC 28 + 0.28 square root of SJC 28 + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP- scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350402|NCT01791205|Secondary|Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy|Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug in combination with DMARDs before monotherapy were considered for this outcome measure.|||Days||Standard Deviation|Mean
1350480|NCT01790633|Primary|Accessibility of Testing Results|The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.|Evaluated once, up to 4 months after testing||||proportion of participants|||Number
1350406|NCT01791205|Secondary|Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy|Mean of tender and swollen joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender and swollen joints was recorded on the joint assessment as no tenderness = 0 and tenderness = 1.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available tender and swollen joints at Baseline are reported.|||Joints||Standard Deviation|Mean
1350407|NCT01791205|Secondary|Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm) VAS; 0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available SDAI score at Baseline are reported.|||Participants|||Number
1350408|NCT01791205|Secondary|Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Number of participants with CDAI scores for both the groups at study entry (baseline) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available CDAI score at Baseline are reported.|||Participants|||Number
1350409|NCT01791205|Secondary|Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity) where higher scores represents higher disease. The DAS28 <2.6 indicates disease remission, >=2.6 and <3.2 indicates Low disease activity, >=3.2 and <=5.1 indicates Moderate disease activity and >5.1 indicates High disease activity. Median score for DAS28 at the study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available DAS28 score at Baseline are reported.|||Scores on scale||Full Range|Median
1350410|NCT01791205|Secondary|Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
1350411|NCT01791205|Secondary|Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy|Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.|||Participants|||Number
1350412|NCT01791205|Secondary|Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs, the second treatment line as the subsequent use of a different biologic drug and so on for the third, fourth, fifth and sixth treatment line. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
1350413|NCT01791205|Secondary|Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy|The table below shows percentage participants who started treatment with a biologic drug in monotherapy compared with percentage of participants who stopped DMARDs while taking a biologic drug in combination.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.|||Percentage of Participants||95% Confidence Interval|Number
1350414|NCT01791205|Secondary|Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy|The HAQ-DI is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Scores on scale||Standard Deviation|Mean
1350415|NCT01791205|Secondary|Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases. Percentage of participants with comorbidity is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Percentage of participants|||Number
1350416|NCT01791205|Secondary|Phase I: Median Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of RA until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Months||95% Confidence Interval|Median
1350417|NCT01791205|Primary|Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18|Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant’s disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At month 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350418|NCT01791205|Primary|Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy|The probabilities of participant to retain on therapy at various time points are reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
1350419|NCT01791205|Primary|Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy|Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
1350420|NCT01791205|Primary|Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
1350421|NCT01791205|Primary|Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy|Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
1350422|NCT01791205|Primary|Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =< 2 and > 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
1350423|NCT01791205|Primary|Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy|The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =< 337 days, > 337 days, =< 336 days, > 336 days are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
1350424|NCT01791205|Primary|Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. Participants with SDAI score =< 8.17 and > 8.17 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.|||Participants|||Number
1350425|NCT01791205|Primary|Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient’s global assessment (PtGA) and physician’s global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Participants with CDAI score =< 7.75 and > 7.75 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.|||Participants|||Number
1350426|NCT01791205|Primary|Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy|The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =< 0.28 and >2.8 milligram/deciliter (mg/dL); and ESR values =< 11 and >11 millimeters/hour (mm/hr) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
1350440|NCT01791153|Secondary|Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab|Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL).|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|PK-evaluable population|||mcg/mL||Standard Deviation|Mean
1350427|NCT01791205|Primary|Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy|The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =< 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Participants with DAS28 score =< 2.6 and > 2.6 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.|||Participants|||Number
1350428|NCT01791205|Primary|Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy|The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =< 0.8625 and > 0.8625 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at the time of evaluation are reported.|||Participants|||Number
1350429|NCT01791205|Primary|Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy|The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
1350430|NCT01791205|Primary|Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
1350431|NCT01791205|Primary|Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
1350432|NCT01791205|Primary|Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy|Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm^2. Participants with age =<, > 59 years, height =<, > 163 cm, weight =<, > 65.85 Kg and BMI =<, > 24.98 Kg/cm^2 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
1350433|NCT01791153|Secondary|Percentage of Participants With Anti-Tocilizumab Antibodies|All samples were tested by screening assay, and those samples that were positive were further analyzed by a confirmation assay to confirm specificity. Percentage of participants who has a positive confirmation assay result any time after the initial drug administration with a negative confirmation assay result at baseline was reported.|Baseline up to Week 52|Safety population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1350434|NCT01791153|Secondary|C-Reactive Protein (CRP) Level|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||milligrams per liter (mg/L)||Inter-Quartile Range|Median
1350435|NCT01791153|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||mm/hr||Inter-Quartile Range|Median
1350436|NCT01791153|Secondary|Serum Soluble IL-6 Receptor (sIL-6R) Level||Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1350437|NCT01791153|Secondary|Serum Interleukin-6 (IL-6) Level||Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1350438|NCT01791153|Secondary|Minimum Observed Serum Concentration (Ctrough) of Tocilizumab|Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL.|Predose (Hour 0) at Baseline and Week 52|PK-evaluable population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||mcg/mL||Standard Deviation|Mean
1350439|NCT01791153|Secondary|Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab|Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL.|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|PK-evaluable population|||mcg/mL||Standard Deviation|Mean
1350901|NCT01785186|Secondary|Rate of Change in Quantitative PCR During Therapy|GeneXpert MTB/RIF (Xpert) quantitative PCR results (counts per week|0 - 12 weeks|||||||
1350441|NCT01791153|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab|AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram*day per milliliter (mcg*day/mL).|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|Pharmacokinetics (PK)-evaluable population included all participants who received at least one tocilizumab injection and had at least one PK sample with detectable results taken at any time during the study.|||mcg*day/mL||Standard Deviation|Mean
1350442|NCT01791153|Secondary|Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52|Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 52|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||mm||Standard Deviation|Mean
1350443|NCT01791153|Secondary|Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52|The SF-36 is a standardized questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Score (PCS) and Mental Component Score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A positive change from baseline indicates improvement. No imputation was used for missing data. Data was set to missing for participants who received escape therapy.|Baseline, Week 52|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||units on a scale||Standard Deviation|Mean
1350444|NCT01791153|Secondary|Total Cumulative Prednisone Dose|The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented.|Up to 52 weeks|ITT Population|||milligrams (mg)||95% Confidence Interval|Median
1350445|NCT01791153|Secondary|Time to First GCA Disease Flare|Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal.|Up to 52 weeks|ITT population|||days||99% Confidence Interval|Median
1350446|NCT01791153|Secondary|Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)|Remission was defined as the absence of flare and normalization of the CRP (<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.|Week 52|ITT population|||percentage of participants|||Number
1350447|NCT01791153|Primary|Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)|Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than [<] 1 milligram per deciliter [mg/dL]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.|Week 52|Intent-to-treat (ITT) population included all participants randomized into the study who received at least one administration of study drug.|||percentage of participants|||Number
1350448|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years were included in the analysis; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.|||IU||Standard Deviation|Mean
1350449|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis and participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.|||IU||Full Range|Median
1350450|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)||4 years|All enrolled participants; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.|||IU||Standard Deviation|Mean
1350451|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years with nonmissing data were included in the analysis.|||IU||Standard Deviation|Mean
1350452|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis.|||IU||Standard Deviation|Mean
1350453|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis (All Participants)||4 years|All enrolled participants; only participants with nonmissing data were included in the analysis.|||IU||Standard Deviation|Mean
1350454|NCT01790828|Secondary|Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha|Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.||||||
1350455|NCT01790828|Secondary|Annualized Bleeding Rates During Prophylaxis|Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)]|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.||||||
1350462|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.|||number of responses|Participants||Number
1350463|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.|||Number of responses|Participants||Number
1350464|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age||4 years|All enrolled participants; participants aged ≥18 years who received on-demand therapy were included in the analysis.|||infusions||Standard Deviation|Mean
1350465|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age||4 years|All enrolled participants; only participants aged <18 years who received on-demand therapy were included in the analysis.|||infusions||Standard Deviation|Mean
1350466|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.|||infusions||Standard Deviation|Mean
1350467|NCT01790828|Primary|Percentage of Participants by Family History of Factor VIII Inhibitor||4 years|All enrolled participants.|||percentage of participants|||Number
1350468|NCT01790750|Primary|False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false negatives between the two systems.|at baseline||||percentage of false negative||Standard Deviation|Mean
1350469|NCT01790750|Primary|False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false positives between the two systems.|at baseline||||percentage of false positives||Standard Deviation|Mean
1350470|NCT01790685|Primary|Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex|Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.|4 months|All enrolled (23 CRVO and 17 BRVO) patients completed the study. All patients were injected with Ozurdex, however microarrays were run on only 11 CRVO and 17 BRVO patient samples. Microarray data from 11 CRVO and 11 BRVO patients was analyzed.|||participants|||Number
1350471|NCT01790659|Secondary|Median Time to Initial Clinical Cure for Index Lesions|Median time to initial clinical cure for index lesions (100% re-epithelialization of the index lesion)|When 100% re-epithelialization of the index lesion is observed at any visit Study Days (20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|MITT subjects|||Days||95% Confidence Interval|Median
1350472|NCT01790659|Secondary|Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point|Area of ulceration (mm^2) of all treated lesions from baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days for mITT subjects. Data presented is as presented in the Final Clinical Study Report; any inconsistencies can't be changed.|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|All lesions for mITT Subjects|||mm^2|Number of lesions|Standard Deviation|Mean
1350473|NCT01790659|Secondary|Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point|Area of ulceration (mm^2) of the index lesion at each measurement time point for mITT subjects|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|mITT subjects|||mm^2||Standard Deviation|Mean
1350474|NCT01790659|Secondary|Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)|Percentage of all lesions meeting criteria for clinical cure during the study at 168 day mark for mITT subjects|Day 168|Cure rates of all lesions over time without regard to subject for mITT subjects|||percentage of lesions|||Number
1350475|NCT01790659|Secondary|Percentage of Subjects With All Lesions Cured|• Percentage of subjects with all lesions cured, defined as: Final clinical cure as defined in primary objective (which is based solely on the index lesion); AND, Cure of all other lesions by nominal Day 100 (100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions)|100 ± 14 days|MITT subjects|||percentage of participants|||Number
1350476|NCT01790659|Primary|Percent of Participants With Final Clinical Cure|"The primary efficacy endpoint is percent of subjects with final clinical cure. Final clinical cure is defined as follows:~Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63) followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,~Subject has no relapse of index lesion."|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|MITT subjects|||percent of participants|||Number
1350477|NCT01790633|Other Pre-specified|Proportion of Rapid Test Failures|The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).|At testing|Only patients randomized to the rapid testing arm.|||proportion of participants|||Number
1350478|NCT01790633|Other Pre-specified|Proportion Participating|The number of individuals accepting to participate in the study divided by the total number of individuals proposed.|At testing||||proportion of participants|||Number
1350479|NCT01790633|Secondary|Access to Care|The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.|Evaluated once, up to 4 months after testing|Analysis includes only participants with positive HIV, HBV, and/or HCV results.|||proportion of participants|||Number
1350481|NCT01790594|Secondary|Count of Participants Diagnosed With Malignancy as an Adverse Event|An increased risk/incidence of malignancy is a recognized complication of immunosuppression in recipients of organ transplants. In Phase 3 clinical trials, overall malignancy rates were similar across all treatment groups, with the exception of posttransplant lymphoproliferative disease (PTLD).Displayed are counts of all participants who experienced malignancy reported as an adverse event.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350482|NCT01790594|Secondary|Count of Participants Diagnosed With Epstein-Barr Virus (EBV) Infection as an Adverse Event|Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples. Displayed are counts of all participants diagnosed with EBV infection as an adverse event by EBV test(s), diagnosed by test results from the local clinical pathology laboratory.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350483|NCT01790594|Secondary|Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events|"Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.~Specific viruses were monitored during this study using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events, diagnosed by test results from the local clinical pathology laboratory."|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Count of Participants|||Number
1350484|NCT01790594|Secondary|Count of Participants With an Infectious Disease Serious Adverse Event(s) Requiring Hospitalization or Systemic Therapy|Infections were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization. Displayed are counts of all participants who experienced infection(s) as an adverse event, by treatment group.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350485|NCT01790594|Secondary|Count of Participants With the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Adverse events were collected systematically. Counts of all participants who experienced at least one adverse event (AEs, SAEs) by assigned treatment group.~Refer to the Serious Adverse Events and Other Adverse Events tables for more detail."|From Enrollment (Pre-Transplant) to Week 52 Post-Transplant|Intent-to-treat population|||Count of Participants|||Number
1350486|NCT01790594|Secondary|Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide|"This measure counts death, graft loss, or undetectable C-peptide value (e.g., C-peptide <0.3 ng/mL) occurring at any point post-transplant and independent of each other.~Kidney Graft Loss was defined as 90 consecutive days of dialysis dependency.~Pancreas graft loss was defined as returning to exogenous insulin therapy or initiation of oral hypoglycemic agents for greater than 30 days.~Factitious hypoglycemia due to surreptitious insulin administration results in elevated serum insulin levels and low or undetectable C-peptide levels."|Transplant through Week 52 Post-Transplant|Intent-to-treat population with available data.|||Participants|||Count of Participants
1350487|NCT01790594|Secondary|Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant|"Participants are stratified by kidney biopsy results/treatment received.~Upon having a for-cause biopsy performed, persons often receive treatment for rejection based on the biopsy results, which may or may not reveal signs of rejection. Details of biopsy findings and corresponding treatment are provided for each instance of treatment for rejection.~Results summary format: biopsy results; treatment.~Acronyms and abbreviations:~ACR=Acute Cellular Rejection~IFTA=Interstitial Fibrosis and Tubular Atrophy~ATG=Anti-thymocyte globulin therapy~IVIG=Intravenous Immunoglobulin therapy~Gd =Grade~PO=Orally~QD=Daily"|Transplant through Week 52|Intent-to-treat population with available data. Only ‘for cause’ biopsies were performed post-transplant.|||Participants|||Count of Participants
1350488|NCT01790594|Secondary|Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant|"Participants are stratified by kidney biopsy results/treatment received.~In the event of a for cause renal (kidney) biopsy:~-The diagnosis of acute cellular rejection (ACR) using the Banff 2007 renal allograft pathology criteria. These criteria for renal allograft biopsies is an international histopathological classification standard. ACR is defined by a renal biopsy demonstrating a Banff 2007 classification of Grade IA or greater, with higher scores indicating more severe rejection. (Ref: Solez K, Colvin RB et al. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant 2008 8(4): 753-60).~Acronyms and abbreviations:~ACR=Acute Cellular Rejection*~Normal*~Borderline* (criteria for ACR not fulfilled)~Gd.=Grade*~IFTA=Interstitial Fibrosis and Tubular Atrophy*~ATG=Anti-thymocyte globulin therapy~IVIG=Intravenous Immunoglobulin therapy~PO=Orally~QD=Daily *Banff 2007 renal allograft pathology criteria"|Transplant through Week 52|Intent-to-treat population with available data. All participants were considered evaluable for rejection. Only ‘for cause’ biopsies were performed post-transplant.|||Participants|||Count of Participants
1350489|NCT01790594|Secondary|Count of Participants With De Novo Anti-Donor Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant|"The de novo development of donor-specific antibody (DSA) is associated with an increased risk of graft rejection.~The presence of anti-Histocompatibility Antigen (HLA) antibodies (alloantibodies) is associated with increased risk of acute and chronic injury to the transplant allograft."|Transplant through Week 52|Intent-to-treat population with available data|||Count of Participants|||Number
1350490|NCT01790594|Secondary|Count of Participants With Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant|"Humoral rejection (i.e., antibody mediated rejection) of:~the kidney as defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury determined by local pathology and,~the pancreas as defined by the presence of circulating anti-donor antibodies, and histopathological data including morphologic evidence of microvascular tissue injury and C4d staining in interacinar capillaries determined by local pathology."|Transplant through Week 52|Intent-to-treat population with available data|||Count of Participants|||Number
1350501|NCT01790594|Secondary|Count of Participants With Evidence of Pancreatic Loss at Week 52 Post-Transplant|C-peptide is a measure of pancreatic function. The definition of pancreatic loss: a C-peptide value of <0.3 ng/mL.|Week 52 Post-Transplant|Intent-to-treat population with available data|||Participants|||Count of Participants
1350491|NCT01790594|Secondary|Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant|"AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.~AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.~AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded is I, II, or III, with I defined as the mildest form of AR and III being the most severe."|Transplant through Week 52|Intent-to-treat population|||Participants|||Number
1350492|NCT01790594|Secondary|Count of Participants With Acute Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant|"Biopsy-proven acute rejection (AR) of the kidney (renal) or pancreas during the first 52 weeks post-transplant. AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.~AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.~AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded as I, II, or III, with I defined as the mildest form of AR and III being the most severe."|Transplant through Week 52|Intent-to-treat population|||Count of Participants|||Number
1350493|NCT01790594|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline, Wk 28 and Wk 52 Post-Transplant|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood|Baseline (Pre-Transplant), Week 28, and Week 52|Intent-to-treat population|||participants|||Number
1350494|NCT01790594|Secondary|Lipid Profile at Wk 52 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 52 Post-Transplant|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
1350495|NCT01790594|Secondary|Fasting Lipid Profile at Wk 28 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 28 Post-Transplant|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
1350496|NCT01790594|Secondary|Fasting Lipid Profile at Baseline (Pre-Transplant)|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Baseline (Pre-Transplant)|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
1350497|NCT01790594|Secondary|Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction.|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||Count of Participants|||Number
1350498|NCT01790594|Secondary|Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|"A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.~Systolic measures of <120 and diastolic measures of <80 are considered normal.~Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).~Systolic measures of ≥140 and diastolic measures of ≥90 are considered high."|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||mmHg||Standard Deviation|Mean
1350499|NCT01790594|Secondary|Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|"Fasting blood sugar (e.g., glucose) test is used to help diagnose diabetes, prediabetes, and gestational diabetes.~Reference fasting blood sugar (glucose) values:~70 to 99 mg/dL is normal~100 to 125 mg/dL is considered prediabetes~126 mg/dL or higher on two separate tests is considered diabetes."|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
1350500|NCT01790594|Secondary|HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|"Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:~A value below 6.0% reflects normal levels,~6.0% to 6.4% reflects prediabetes, and~a value of ≥ 6.5% reflects diabetes."|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||percent||Standard Deviation|Mean
1350502|NCT01790594|Secondary|Count of Participants With Evidence of Partial Pancreatic Graft Function at Week 52 Post-Transplant|C-peptide is a measure of pancreatic function. The definition of partial pancreatic graft function: a fasting C-peptide levels >0.3ng.mL (0.1nmol.L) plus the participant's continued requirement for exogenous insulin or oral hypoglycemic agent(s).|Week 52 Post-Transplant|Intent-to-treat population with available data|||Participants|||Count of Participants
1350503|NCT01790594|Secondary|Count of Participants With Full Pancreatic Graft Function (Insulin Independent) at Wk 52 Post-Transplant|Participants with full pancreatic graft functions are defined as those that no longer require exogenous insulin therapy.|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350504|NCT01790594|Secondary|Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant|Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350505|NCT01790594|Secondary|Count of Participants With Successful Discontinuation of Tacrolimus in Recipients Randomized to the Investigational Arm|Participants achieved successful discontinuation if they were able to discontinue (e.g., off tacrolimus therapy completely) over a 4-8 weeks after tacrolimus withdrawal was initiated at week 40.|Week 40 through week 48 Post-Transplant|Intent-to-treat population with available data|||Participants|||Count of Participants
1350506|NCT01790594|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or endstage kidney failure.~An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.~Larger numbers indicate greater change in kidney function."|Day 28 through Week 52 Post-Transplant|Intent-to-treat population|||eGFR change over time (by month)||Standard Deviation|Mean
1350507|NCT01790594|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate severe or endstage kidney failure."|Week 52 Post-Transplant|Intent-to-treat population|||mL/min/1.73m^2||Standard Deviation|Mean
1350508|NCT01790594|Secondary|Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant|"The stages of Chronic Kidney Disease (CKD) are defined using the participant’s GFR value:~Stage 1 if GFR value is ≥ 90 (kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 <= GFR < 60*~Stage 3B if 30 <= GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A abd 3B indicate moderately reduced kidney function.*"|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350509|NCT01790594|Secondary|Count of Participants by CKD Stage at Wk 52 Post-Transplant|"The stages of Chronic Kidney Disease are defined using the participant’s GFR value:~Stage 1 if GFR value is ≥90 ( kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 ≤ GFR < 60*~Stage 3B if 30 ≤ GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A and 3B indicate moderately reduced kidney function.*"|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350510|NCT01790594|Secondary|Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
1350511|NCT01790594|Primary|Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52 Post-Transplant|Intent-to-treat population with available data at week 52.|||mL/min/1.73m^2||Standard Deviation|Mean
1350512|NCT01790581|Secondary|Self-assessed Disability|3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-month post intervention|||||||
1350513|NCT01790581|Secondary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-week post intervention|||||||
1350550|NCT01790178|Secondary|Number of Participants With Inadequate Biopsy Samples|The presence of an inadequate sample was determined by the blinded pathologist reading the muscle biopsies. This reflects the sample having enough preserved muscle tissue for histologic analysis. It is separate from the number of participants receiving a diagnosis. A sample may be adequate, but non-diagnostic. Only one biopsy was performed in each patients, so the number of biopsies is the same as the number of participants.|At time of pathology review||||Inadequate Biopsy Samples|||Number
1350514|NCT01790581|Primary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient’s score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.|Disability to 1-day post intervention||||% of total questionnaire points||Standard Deviation|Mean
1350515|NCT01790581|Secondary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Change from baseline balance at 1-week post intervention|||||||
1350516|NCT01790581|Primary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Balance at 1-day post intervention||||% of leg length||Standard Deviation|Mean
1350517|NCT01790568|Secondary|Non-Relapse Mortality Incidence||1 year||||percentage of patients||95% Confidence Interval|Number
1350518|NCT01790568|Secondary|Percentage of Patients Alive at 1 Year|Overall survival at 1 Year.|1 Year||||percentage of patients||95% Confidence Interval|Number
1350519|NCT01790568|Primary|Percentage of Patients That Experience Grade 2-4 GVHD Within 100 Days of Transplant|"GVHD Staging:~Grade 2: (Skin) Maculopapular rash 25-50% BSA, (Liver) bilirubin 3.1-6mg/dl, (Gut) 1000-1500 ml/day for adult and 20-30ml/kg/day for child.~Grade 3: (Skin) Maculopapular rash >50% BSA, (Liver) 6.1-15mg/dl, (Gut) >1500mg/day for adult and >30ml/kg/day for child.~Grade 4: (Skin) Generalized erythroderma plus bullous formation and desquamation >5% BSA, (Liver) >15mg/dl, (Gut) Severe abdominal pain with or without ileus, or grossly bloody stool."|100 Days||||percentage of patients||95% Confidence Interval|Number
1350520|NCT01790516|Primary|Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician|"Feasibility is defined as follows:~- Patients' genetic test results are returned to the treating physician within 3 days"|20 months||||days||Full Range|Median
1350521|NCT01790490|Other Pre-specified|Cocaine Use in Follow-up|Weekly assessment of cocaine use by urine toxicology and history|4-week follow up|||||||
1350522|NCT01790490|Other Pre-specified|Change in Physiological Reactivity|Assesses level of physiological arousal to cues using galvanic skin response|change across infusions over 9 days|||||||
1350523|NCT01790490|Secondary|Risk of Initiating Experimental Drug Misuse|Weekly assessment of drug use by history and urine toxicology|4 week follow-up after completion of inpatient phase|||||||
1350524|NCT01790490|Secondary|Acute Tolerability|Various measures ascertain level of dissociation, abuse liability, and behavioral disturbances.|immediately after each infusion over 5 days|||||||
1350525|NCT01790490|Primary|Change in Motivation to Quit|Motivation score obtained from the University of Rhode Island Change Assessment (URICA). Scores are obtained at baseline and at 24 hours after each infusion. The scores are 0-13, with higher scores indicating greater motivation. The analysis is within-subject. Scores included below are means; higher scores represent higher motivation to quit than do lower scores.|Baseline and 24 hours post-infusion||||units on a scale||Full Range|Mean
1350526|NCT01790490|Primary|Change in Cue Reactivity|Serial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion.|Baseline and 24 hours after infusion||||units on a scale (0-200), high is worse||Standard Error|Median
1350527|NCT01790438|Secondary|Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable EuroQol-5D-3L data.|||units on a scale||Standard Deviation|Mean
1350528|NCT01790438|Secondary|Percentage of Participants With Severe Hypoglycemic Events|Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The percentage of participants with at least one severe hypoglycemia is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||percentage of participants|||Number
1350529|NCT01790438|Secondary|Rate of Severe Hypoglycemic Events|Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The hypoglycemia rate per 100 years during a defined period was calculated by the number of hypoglycemia events within the period divided by the number of days participant at risk within the period*36525 days.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||events per 100 participant years||Standard Deviation|Mean
1350530|NCT01790438|Secondary|Percentage of Participants With Injection Site Reactions|The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH.|||percentage of participants|||Number
1350902|NCT01785186|Secondary|Rate of Change in Time to Positivity|Rate of change in time to positivity in BD MGIT 960® liquid culture|0 - 12 weeks|||||||
1350531|NCT01790438|Secondary|Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants reaching target HbA1c without nocturnal hypoglycemia divided by the total number of participants analyzed, multiplied by 100.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data and hypoglycemia data.|||percentage of participants|||Number
1350532|NCT01790438|Secondary|Percentage of Participants With Total and Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants with at least one hypoglycemia divided by the total number of participants analyzed, multiplied by 100.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||percentage of participants|||Number
1350533|NCT01790438|Secondary|Intra-Participant Variability in FBG by the Coefficient of Variation|Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1350534|NCT01790438|Secondary|Intra-Participant Variability in FBG by Standard Deviation|Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline FBG variability as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.|||mg/dL||Standard Deviation|Least Squares Mean
1350535|NCT01790438|Secondary|Percentage of Participants With Insulin Antibodies|The percentage of participants with a positive treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR was defined as change from baseline to postbaseline in the anti-LY2605541 antibody level either (1) from undetectable to detectable or (2) from detectable to the value with at least 130% relative increase from baseline. Percentage of participants was calculated by dividing the number of participants with TEAR anytime during the treatment period by the total number of participants analyzed, multiplied by 100.|Baseline to 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable anti-drug (LY2605541) antibodies (ADA) data.|||percentage of participants|||Number
1350536|NCT01790438|Secondary|Change From Baseline to 26 Weeks in Lipid Profile|Lipid profile includes total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. LS means for post-baseline measures were calculated using MMRM with the fixed effects of stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. LS means for End Of Study measures were calculated using ANCOVA adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL]except for the LDL-C outcome variable), treatment, and baseline value of corresponding lipid outcome variable.|Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks)|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable lipid data. Missing endpoints for End Of Study measures were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
1350537|NCT01790438|Secondary|Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores|Adult LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (always). Items are categorized in 2 domains: Behavior (or avoidance) with 15 items and Worry (or affect) with 18 items. Sum all the items to obtain a total score (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, stratification factor (country, baseline sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c (≤8.5% or >8.5%), and baseline value of LBSS.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable LBSS data. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1350538|NCT01790438|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, higher scores indicate better treatment satisfaction. LS means were calculated using analysis of variance (ANOVA) adjusting for treatment and stratification factors (country, baseline sulfonylureas/meglitinide use [Yes/No], baseline HbA1c [≤8.5% or >8.5%]).|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable ITSQ data. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1350551|NCT01790178|Secondary|Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue|"For core or needle biopsies, the physician passes the needle into the muscle until they feel that adequate tissue samples have been obtained. This outcome measure is the number of passes required in each study arm."|At time of biopsy||||needle passes||Standard Deviation|Mean
1350552|NCT01790178|Secondary|Number of Participants With Adverse Events Related to Muscle Biopsy|Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.|Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy||||participants|||Number
1350539|NCT01790438|Secondary|Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and extreme problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United States (US) population-based algorithm. The EQ-5D-3L US based index scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. LS means were calculated from ANCOVA using treatment, stratification factor (country, baseline sulfonylurea sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]) and baseline value of EQ-5D-3Las covariates.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable EQ-5D-3L data. Missing endpoints were imputed with the last observation carried forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
1350540|NCT01790438|Secondary|Time to Steady-State (Stable Maximum Dose)|Steady-state was defined as the first local maximum dose (peak dose value) of LY2605541 or human insulin NPH within the window of -2 to +2 weeks. The median time to steady-state of basal insulin dose estimated from Kaplan-Meier analysis was summarized by treatment.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable steady state data.|||weeks||95% Confidence Interval|Median
1350541|NCT01790438|Secondary|Insulin Dose Per Kilogram (kg) of Body Weight|LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, and treatment-by-visit interaction as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable insulin dose and body weight data.|||units per kilogram||Standard Error|Least Squares Mean
1350542|NCT01790438|Secondary|HbA1c|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1350543|NCT01790438|Secondary|Change From Baseline to 26 Weeks in Body Weight|LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline weight as the fixed effects.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
1350544|NCT01790438|Secondary|6-Point Self-Monitored Blood Glucose (SMBG)|6-point SMBG profiles were obtained on 3 nonconsecutive days in the week prior to Weeks 0, 4, 8, 12, 16, and 26. The SMBG measurements were performed while fasting (prior to the morning meal [breakfast]), prior to the midday meal (lunch), prior to the evening meal (dinner), at bedtime, at approximately 0300 hours, and the next day fasting (prior to the morning meal). LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), ], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline SMBG at the same time point of the response variable as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable blood glucose data.|||mg/dL||Standard Error|Least Squares Mean
1350545|NCT01790438|Secondary|Fasting Blood Glucose (FBG) (by Self Monitoring)|LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1350546|NCT01790438|Secondary|Fasting Serum Glucose (FSG) (by Laboratory)|LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FSG.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1350547|NCT01790438|Secondary|Percentage of Participants With HbA1c ≤6.5% and <7.0%|Percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.|||Percentage of Participants|||Number
1350548|NCT01790438|Secondary|30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline event rate of the corresponding hypoglycemia as covariates, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||episodes per participant per 30 days||Standard Error|Mean
1350549|NCT01790438|Primary|Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)|Glycosylated hemoglobin A1 (HbA1c) is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1350903|NCT01785186|Secondary|Proportion of Negative Sputum Cultures|Proportion of patients converting to negative sputum culture (2 consecutive weekly cultures) in liquid and solid media|0 - 12 weeks|||||||
1350555|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Electrocardiogram Findings During the Double-Blind Treatment Period|Data represents the number of participants with potentially clinically significant (PCS) electrocardiogram findings on the final study visit.|Final study visit (week 12 or end of treatment visit)|Full analysis set|||Participants|||Count of Participants
1350556|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Sign Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 to Week 12 of the Treatment Period|Full analysis set|||Participants|||Count of Participants
1350557|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Alanine aminotransferase (ALT): >=3* upper limit of normal (ULN)~Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN)~Serum white blood cells: <=3.0 * 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Eosinophils: >=10.0 %~Absolute neutrophils: <=1.0 * 10^9/L~Urinalysis: Glucose: >=2 unit increase from baseline"|Day 1 up to Week 12 of the Treatment Period|Full analysis set including participants with laboratory assessments. Participants with a postbaseline result for that test are counted in each laboratory tests' label.|||Participants|||Count of Participants
1350558|NCT01789970|Secondary|Clinical Opiate Withdrawal Scales (COWS) Total Scores During the Double-Blind Treatment Period|"COWS is a clinician-rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at weeks 1, 2, 4, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5.~A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows:~0 to 4=normal~5 to 12=mild~13 to 24=moderate~25 to 36=moderately severe~36=severe"|Weeks 1, 2, 4 and Endpoint of the Treatment Period|Full analysis set. Participants contributing to each time point are listed in the time point label.|||units on a scale||Standard Deviation|Mean
1350559|NCT01789970|Secondary|Subjective Opiate Withdrawal Scales (SOWS) Total Scores During the Double-Blind Treatment Period|The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at week 12 or early termination. The SOWS was a self-administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (such as my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.|Weeks 1, 2, 4 and Endpoint of the Treatment Period|Full analysis set. Participants contributing to each time point are listed in the time point label.|||units on a scale||Standard Deviation|Mean
1350560|NCT01789970|Secondary|Participants With Clinically Significant Hearing Changes From Baseline to Final Assessment in Pure Tone Audiometry Test Results|Pure tone audiometry was performed by a qualified audiologist and was not done at the study center. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient’s hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (Konrad-Martin et al 2005). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to “no response” at 3 consecutive test frequencies.|Days 7-14 of Titration Period (baseline), Day 0 of Treatment Period (last day of Titration Period), Week 12 or end of study visit during the Treatment Period|Safety analysis set (entire study), Full analysis set (treatment period)|||Participants|||Count of Participants
1350561|NCT01789970|Secondary|Participants With Adverse Events During Open-Label Titration and Double-Blind Treatment Periods|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of Titration Period up to Week 12 of Treatment Period (maximum treatment duration was 127 days)|Safety analysis set (Titration Period) and Full analysis set (Treatment Period)|||Participants|||Count of Participants
1350562|NCT01789970|Secondary|Change From Baseline to Final On-Treatment Visit in Roland Morris Disability Questionnaire (RMDQ) Score|The RMDQ is a patient-rated, 24-question evaluation used to assess acute disability associated with low back pain. Each question is answered with a YES or NO response, and each YES response is given 1 point. Scores on the RMDQ range from 0 to 24, with higher scores indicating greater disability. Negative change from baseline scores indicate improvement in level of disability.|Days 7-14 of Titration Period (baseline), Week 12 or end of study visit during the Treatment Period|Full analysis set, including participants with RMDQ score for the final on-treatment visit.|||units on a scale||Standard Deviation|Mean
1350633|NCT01788215|Secondary|Total Number of Ovulations|The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.|week 24|In the sugar pill arm, one participant withdrew at week 12.|||ovulations|||Number
1350563|NCT01789970|Secondary|Percentage of Participants With a 30% or Greater Increase in Weekly Average Pain Intensity (API) From Baseline to Week 12 Visit, and an Average API Score of 5 or Higher at Week 12|The API over the last 24 hours was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit.|Days -6 to 0 of Treatment Period (baseline), Week 12|Full analysis set, including participants with observed weekly average API for week 12|||percentage of participants|||Number
1350564|NCT01789970|Secondary|Kaplan-Meier Estimates for Time to Loss of Efficacy|Time to loss of efficacy was defined as discontinuation of study drug for lack of efficacy or the start of excessive rescue medication while taking study drug. Excessive rescue medication usage was defined as 10 or more days of rescue medication usage in any 14 consecutive days at a total of 15 mg (hydrocodone-equivalent) or higher each day during the post 2-week tapering period of the double-blind treatment period.|Day 1 to Week 12 of Treatment Period|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.|||days||95% Confidence Interval|Median
1350565|NCT01789970|Secondary|Change From Baseline to Week 12 of the Treatment Period in Weekly Average Pain Intensity (API)|"The API over the last 24 hours was recorded daily by patients in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control.~The analysis included API data observed before discontinuation of study drug and was based on the MI method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events."|Days -6 to 0 of Treatment Period (baseline), Week 12|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.|||units on a scale||Standard Error|Mean
1350566|NCT01789970|Primary|Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI)|"The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their worst pain intensity over the last 24 hours. Weekly WPI scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control.~The analysis included WPI data observed before discontinuation of study drug and was based on the multiple imputations (MI) method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events."|Days -6 to 0 of Treatment Period (baseline), Week 12 of Treatment Period|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.|||units on a scale||Standard Error|Mean
1350567|NCT01789814|Primary|Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.|"To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel.~The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response to agonists: 20 mM ADP(P2Y12), 5 mM SFLLRN (PAR1), and 160 mM AYPGKF (PAR4) was performed. The magnitude of inhibition of platelet aggregation for each agonist was calculated as the mean final change from baseline in light transmission aggregometry at each time point."|Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion|24 patients referred for intervention with planned bivalirudin therapy, not previously treated with a P2Y12 inhibitor and not receiving heparins or GP IIb/IIIa inhibitors were randomized to treatment with either clopidogrel (600 mg) or prasugrel (60 mg).|||% inhibitn of platelet aggregation|||Number
1350568|NCT01789775|Primary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29||||participants|||Number
1350569|NCT01789775|Secondary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.|D1|||||||
1350570|NCT01789606|Secondary|Maximum Daily Dose of Study Medication||Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||milligram||Standard Deviation|Mean
1350571|NCT01789606|Secondary|Average Daily Dose of Study Medication||Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||milligram||Standard Deviation|Mean
1350572|NCT01789606|Secondary|Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms|In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||dosing occasions||Standard Deviation|Mean
1350573|NCT01789606|Secondary|Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram|In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||dosing occasions||Standard Deviation|Mean
1350574|NCT01789606|Secondary|Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms|In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||days||Standard Deviation|Mean
1350575|NCT01789606|Secondary|Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram|Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||days||Standard Deviation|Mean
1350576|NCT01789606|Secondary|Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users|In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, based on the information provided at the follow up interview.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.|||pain episodes||Standard Deviation|Mean
1350577|NCT01789606|Secondary|Number of Dosing Days Among Inappropriate Users|Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, if left untreated, based on the information provided at the follow up interview.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
1350578|NCT01789606|Secondary|Average Daily Dose Among Excessive Users|Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of >1600 mg or all participants who used the study medication for <=10 days during study period, used more than 20 tablets and had an average daily dose of >1600 mg.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.|||milligram||Standard Deviation|Mean
1350579|NCT01789606|Primary|Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg|Percentage of participants who used the study medication for <=10 days and used more than 20 tablets with an average daily dose of >1600 mg were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||percentage of participants||95% Confidence Interval|Number
1350580|NCT01789606|Primary|Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg|Percentage of participants with the use of study medication for >10 days with an average daily dose of >1600 mg were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||percentage of participants||95% Confidence Interval|Number
1350581|NCT01789606|Primary|Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours|Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain >=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1350582|NCT01789606|Primary|Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours|Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain <6 hours were reported in this outcome measure.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1350609|NCT01788631|Primary|Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More|To determine if infusional Regadenoson reduced iNKT cell activation among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo by 70% or greater.|Baseline-End of study infusion over 48 hours|Treated patients with baseline and end of infusion blood samples.|||Participants|||Count of Participants
1350583|NCT01789606|Primary|Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity|Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of <6 hours, if left untreated. Participants were classified as “missed opportunity” cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain >=6 hours.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1350584|NCT01789606|Primary|Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication|Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (<) 6 hours, if left untreated.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire.|||percentage of participants||95% Confidence Interval|Number
1350585|NCT01789567|Other Pre-specified|Composite Clinical Efficacy Endpoint After 30 Days According to VARC2|"Percentage of Participants with any of the following Safety Events after 30-days post-procedure:~All-cause mortality All stroke Hospitalization for valve-related symptoms or worsening congestive heart failure"|30-days post-procedure|Analysis for this endpoint includes subjects at risk (or alive and in study) at 30 days.|||percentage of participants|||Number
1350586|NCT01789567|Other Pre-specified|Composite 30-day Safety Endpoint According to VARC2|"Percentage of Participants with any of the following Safety Events within 30-days post-procedure:~All-cause mortality All stroke Life-threatening bleeding Acute kidney injury (stage 2-3) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)"|30-days post-procedure|Analysis for this endpoint includes subjects with an implant attempt.|||percentage of participants|||Number
1350587|NCT01789567|Other Pre-specified|Device Success According to VARC2|"Device success is a composite of:~Absence of 30-day in-hospital death Correct position of the device within the aortic annular region Intended performance of the bioprosthesis (no patient-prosthesis mismatch, mean aortic gradient <20 mmHg or peak velocity <3 m/s at discharge, and no moderate or severe prosthetic valve regurgitation)"|30 days post-procedure|Analysis for this endpoint includes subjects with an implant attempt.|||percentage of participants||95% Confidence Interval|Number
1350588|NCT01789567|Primary|Acute Delivery System Success|Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure.|Within 30 days of implant procedure|Analysis for this endpoint includes subjects with an implant attempt.|||percentage of participants||95% Confidence Interval|Number
1350589|NCT01789476|Secondary|Summed Pain Intensity Differences Over 48 Hours (SPID 0-48) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug.~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 48 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.|||units on a scale * hours||Standard Deviation|Mean
1350590|NCT01789476|Secondary|Summed Pain Intensity Differences Over 36 Hours (SPID 0-36) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 36 hours used in calculating SPID 0-36).~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 36 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.|||units on a scale * hours||Standard Deviation|Mean
1350591|NCT01789476|Primary|Summed Pain Intensity Differences Over 24 Hours (SPID 0-24) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 24 hours used in calculating SPID 0-24).~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.|||units on a scale * hours||Standard Deviation|Mean
1350634|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 24|in the sugar pill arm, one participant withdrew at week 12|||nmol /L||Standard Deviation|Mean
1350592|NCT01789255|Secondary|Median Plasma Concentration of IL-6 in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat|Median plasma concentration of IL-6 (Interleukin-6 cytokine) was compared in patients treated with Vorinostat to those not treated with Vorinostat.|Up to day 100|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||pg/mL||Full Range|Median
1350593|NCT01789255|Secondary|Median Ac-H3 Levels in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat|Median Ac-H3 levels ( depicted as a ratio of ac-H2 optical density (OD) and beta actin OD) were compared in patients treated with Vorinostat to patients not treated with Vorinostat. Optical Density is a dimensionless unit.|Up to day 100|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||Ratio||Full Range|Median
1350594|NCT01789255|Secondary|The Percentage of Patients With Relapse at 1 Year||Up to 1 year||||percentage of patients|||Number
1350595|NCT01789255|Secondary|The Percentage of Patients Alive at 1 Year|The percentage of patients alive at 1 year|Up to 1 year|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||percentage of patients|||Number
1350596|NCT01789255|Secondary|The Percentage of Patients Alive Without GVHD or Use of Steroids|The percentage of patients alive without GVHD or use of steroids at 1 year.|Up to 1 year|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||percentage of patients|||Number
1350597|NCT01789255|Secondary|Mean Percent of Planned Dose Administered|The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.|Up to day 30||||percent of dose administered||Full Range|Mean
1350598|NCT01789255|Primary|The Number of Participants That Experience Grade 2-4 Acute GVHD (Graft Versus Host Disease) by Day 100|"The incidence of grade 2-4 acute GVHD (Graft Versus Host Disease) by day 100~Grade 2 GVHD: Maculopapular rash covering 25-50% of BSA (Body Surface Area), bilirubin between 3.1-6 mg/dl, and/ or adult stool output between 1000-1500 ml/day (child between 20-30 ml/kg/day).~Grade 3 GVHD: Maculopapular rash covering >50% of BSA, bilirubin between 6.1-15 mg/dl, and/ or adult stool output >1500 ml/day (child >30 ml/kg/day).~Grade 4 GVHD: Generalized erythroderma plus bullous formation and desquamation >5% BSA, bilirubin >15 mg/dl, and/ or severe abdominal pain with or without ileus, or grossly bloody stool."|Day 100||||participants|||Number
1350599|NCT01789138|Secondary|HIV-1 RNA Count / Viral Load (VL)|Undetectable viral load: HIV-1 RNA <40 copies/mL|12 months|Number of participants who completed the 12-month study|||participants|||Number
1350600|NCT01789138|Primary|Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)||12 months|Number of participants who completed the study|||participants|||Number
1350601|NCT01788943|Secondary|Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.|Measure is post-scan subtracted from pre-scan ratings. Rating is measured using the standardized, Questionnaire on Smoking Urges - Brief Version (QSU-Brief) is a standardized measure consisting of 10 statements, each rated on a Likert-like scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Responses for each item are summed to produce an overall score with a range of 10-70.|Before and immediately following the PET scan.||||units on a scale||Standard Deviation|Mean
1350602|NCT01788943|Primary|Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.|Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.|following overnight nicotine abstinence||||Distribution Volume Ratio (Vt/fp)||Standard Deviation|Mean
1350603|NCT01788631|Secondary|Level of Inflammatory Markers (IFN-gamma)|To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of treatment samples|||IFN-gamma levels as percent of baseline||Full Range|Median
1350604|NCT01788631|Secondary|Level of Inflammatory Markers (IL-4)|To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||IL-4 levels as percent of baseline||Full Range|Median
1350605|NCT01788631|Secondary|Level of Inflammatory Markers (A2A)|To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||A2A levels as percent of baseline||Full Range|Median
1350606|NCT01788631|Secondary|Opioid Use|To determine if regadenoson reduces opioid use among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||mg/kg/hr||Full Range|Median
1350607|NCT01788631|Secondary|Number of Participants With an Improvement in Respiratory Symptoms|To determine if regadenoson improved respiratory symptoms among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo. Patients were classified as having an improvement in respiratory symptoms if they experienced any of the following outcomes:(1) respiratory rate decreased by 25% from baseline or normalized (≤20 bpm) or (2) degree of hypoxia (SpO2) on room air increased by 10% from baseline or normalized (≥92%) or (3) thoracic pain improved by 3 points from baseline on a 10-point visual analog scale.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||Participants|||Count of Participants
1350608|NCT01788631|Secondary|Length of Hospital Stay|To determine if regadenoson reduces length of hospital stay among individuals admitted with SCA and pain or ACS compared to placebo|Hospital Presentation- Hospital Discharge, assessed up to 1 month|All patients who had baseline and end of infusion blood samples.|||Days||Full Range|Median
1350610|NCT01788566|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline up to 30 Days Post Last Infusion (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for antibodies.|||participants|||Number
1350611|NCT01788566|Secondary|Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab|Pre-infusion Minimum Concentration (Cmin) and post-infusion (Cmax) necitumumab serum concentration|Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1|All participants who received any amount of study treatment and had evaluable data for Cmax|||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
1350612|NCT01788566|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent improvement from baseline in the sum of target lesions.|Baseline until Measured Progressive Disease (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for CTS.|||percent change||Standard Deviation|Mean
1350613|NCT01788566|Secondary|Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR is best overall response of SD, PR or CR. According to RECIST v1.1, PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Percentage of participants who achieved disease control = (those participants counted in the denominator with a best tumor response of SD, PR, or CR)/(the same denominator as for ORR)*100.|Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.|||percentage of participants||95% Confidence Interval|Number
1350614|NCT01788566|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)|All participants who received any quantity of study treatment.|||months||95% Confidence Interval|Median
1350615|NCT01788566|Secondary|Overall Survival (OS)|Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date.|Baseline to Death from Any Cause (up to 17 Months)|All participants who received any amount of study treatment. Participants censored=34.|||months||95% Confidence Interval|Median
1350616|NCT01788566|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.|Baseline to Measured Progressive Disease (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.|||Percentage of participants||95% Confidence Interval|Number
1350617|NCT01788358|Secondary|Blood Pressure Response Rate at Weeks 28 and 52|Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of <140 mmHg or a reduction of MSSBP of more than (>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of <90 mmHg or a reduction of MSDBP of >10 mmHg from baseline value).|Weeks 28 and 52|mITT|||percentage of subjects|||Number
1350618|NCT01788358|Secondary|Blood Pressure Control Rate at Weeks 28 and 52|Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg.|Weeks 28 and 52|mITT|||percentage of subjects|||Number
1350619|NCT01788358|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52||Baseline (Week 0), Weeks 28 and 52|mITT|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1350620|NCT01788358|Secondary|Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52||Baseline (Week 0), Weeks 28 and 52|Modified intention-to-treat analysis set (mITT): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1350621|NCT01788358|Secondary|Number of Subjects With Clinically Relevant Changes in Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.|Baseline (Week 0) up to Week 52/EOS|SAF|||Subjects|||Number
1350622|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of study treatment up to Week 52/EOS|SAF|||Subjects|||Number
1350623|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 52/EOS|SAF|||Subjects|||Number
1350624|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of first study drug administration up to Week 28|SAF|||Subjects|||Number
1350625|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28|An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 28|Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.|||Subjects|||Number
1350626|NCT01788228|Secondary|Assessment of Psychometric Validity and Internal Consistency of the Daily SF-36v2 Questionnaire||Day 0 to Day 7 for daily SF-36v2 questionnaires||2020-12-31|12/2020||||
1350627|NCT01788228|Secondary|Assessment of the Quality of Life Measures Overall and by Age Category (18-40; 41-64; 18-64; and >64 Years of Age) Via SF-36v2® Health Assessment Questionnaires||Day 0 and Day 7, Day 21 and Day 28 for weekly SF-36v2 questionnaires and Day 0 to Day 7 for daily SF-36v2 questionnaires||2020-12-31|12/2020||||
1350628|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
1350629|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events (AEs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as occurrence of any pIMD regardless of intensity grade or relation to vaccination. Related was defined as pIMD(s) considered by the investigator to have a causal relationship to vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
1350630|NCT01788228|Primary|Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
1350631|NCT01788228|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever [oral temperature above 38.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
1350632|NCT01788228|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
1350639|NCT01788215|Secondary|Serum Progesterone Levels in Blood|Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.|24 weeks|This measurement was not completed, because the number of ovulations was measured in its place and better indicates the effect of the treatment. See outcome measure number 8.||||||
1350640|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 24.|24 weeks|in the sugar pill arm one participant dropped out at week 12|||ng/dL||Standard Deviation|Mean
1350641|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status||At Screening|Tumour Evaluable Population|||Participants|||Number
1350642|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country||At Screening|Tumour Evaluable Population|||Participants|||Number
1350643|NCT01788163|Secondary|Number of Organs With Metastasis by Plasma EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Plasma Evaluable Population|||Number||Standard Deviation|Mean
1350644|NCT01788163|Secondary|Time Since First NSCLC Diagnosis by Plasma EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Plasma Evaluable Population|||Months||Standard Deviation|Mean
1350645|NCT01788163|Secondary|Demographics and Disease Characteristics by Plasma EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Plasma Evaluable Population|||Participants|||Number
1350646|NCT01788163|Secondary|Number of Organs With Metastasis by Tumour EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Tumour Evaluable Population|||Number||Standard Deviation|Mean
1350647|NCT01788163|Secondary|Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Tumour Evaluable Population|||Months||Standard Deviation|Mean
1350648|NCT01788163|Secondary|Demographics and Disease Characteristics by Tumour EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Tumour Evaluable Population|||Participants|||Number
1350649|NCT01788163|Secondary|Plasma EGFR Mutation Testing Turnaround Time|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population|||Time (Days)||Standard Deviation|Mean
1350650|NCT01788163|Secondary|Plasma EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Enrolled Population|||Percentage of Participants|||Number
1350651|NCT01788163|Secondary|Plasma EGFR Mutation Testing|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.|At Screening|Enrolled Population|||Participants|||Number
1350652|NCT01788163|Secondary|Tumour EGFR Mutation Testing Turnaround Time|Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population|||Time (Days)||Standard Deviation|Mean
1350653|NCT01788163|Secondary|Tumour EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.|At Screening|Enrolled Population|||Percentage of Participants|||Number
1350654|NCT01788163|Secondary|Tumour EGFR Mutation Testing|Frequencies of tumour EGFR mutation testing practices parameters.|At Screening|Enrolled Population|||Participants|||Number
1350655|NCT01788163|Secondary|Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.|At Screening|Tumour and Plasma Evaluable Population|||Percentage|||Number
1350656|NCT01788163|Secondary|Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.|At Screening|Tumour and Plasma Evaluable Population|||Percentage|||Number
1350657|NCT01788163|Secondary|Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Tumour and Plasma Evaluable Population|||Percentage|||Number
1350658|NCT01788163|Primary|Plasma EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country|At Screening|Plasma Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
1350659|NCT01788163|Primary|Plasma EGFR Mutation by Subtype|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Plasma Evaluable Population|||Participants|||Number
1350660|NCT01788163|Primary|Overall Plasma EGFR Mutation Status|Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Plasma Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
1350661|NCT01788163|Primary|Tumour EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
1350662|NCT01788163|Primary|Tumour EGFR Mutation by Subtype|Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Tumour Evaluable Population|||Participants|||Number
1350668|NCT01788046|Secondary|Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|Participants who had no scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set|||percentage of participants|||Number
1350669|NCT01788046|Primary|Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase|Participants who did not have any scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|The full analysis set, consisting of all randomized participants|||percentage of participants|||Number
1350670|NCT01787916|Secondary|Assessment of Changes on Adipose Tissue|To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue|Measure changes in the composite at 24 and 52 weeks from baseline||2017-12-31|12/2017||||
1350671|NCT01787916|Primary|Assessment of Changes in Glycemic Control by HbA1c.|To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.|Measure changes in HbA1c at 24 and 52 weeks from baseline||||percentage of HbA1c||Standard Deviation|Mean
1350672|NCT01787838|Primary|Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients|Pneumococcal vaccination rates, tracked biweekly, following 1) staff education, audit and feedback of rates and 2) patient education|12 Months||||participants|||Number
1350673|NCT01787825|Secondary|Preference Between CapsoCam SV-1 and PillCam SB2|Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects|Study Completion|For CapsoCam SV-1 and PillCam SB2 preference data was captured for 113 subjects.|||participants|||Number
1350674|NCT01787825|Secondary|Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2|Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.|Study Completion||||participants|||Number
1350675|NCT01787825|Secondary|Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2|Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.|Study Completion|For CapsoCam SV-1 data was captured for 112 subjects total transit time. For PillCam SB2, data was captured for 110 subjects for total transit time.|||hours||Standard Deviation|Mean
1350676|NCT01787825|Primary|Normal vs Abnormal, Overall Impression|The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.|Study Completion|Note: Each participant swallowed both Pill Cam and CapsoCam approximately 30-60 minutes apart. the order in which the cams were swalloed was randomized.|||participants|||Number
1350677|NCT01787799|Primary|In-stent Late Loss|In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)|9 month|The primary endpoint would be considered to have been met if the SYNERGY in-stent late loss was less than the performance goal of 0.40 mm. The Intent To Treat (ITT) and per protocol populations were identical.|||mm||95% Confidence Interval|Mean
1350678|NCT01787760|Primary|Spherical Equivalent Refraction|Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.|||diopter (D)|eyes|Standard Deviation|Mean
1350679|NCT01787760|Primary|Axial Length (Axial Elongation)|Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.|||millimeter (mm)|eyes|Standard Deviation|Mean
1350680|NCT01787591|Primary|Estimated Absorption (% Dose)|Absorption of deuterium labelled alpha-tocopherol|0-72 h post-meal||||% dose||Standard Error|Mean
1350681|NCT01787591|Primary|Elimination Rate|Rate of plasma elimination of deuterium labelled alpha-tocopherol|0-72 h post-meal||||mmol/L/h||Standard Error|Mean
1350682|NCT01787591|Primary|Tmax|Time to maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal||||h||Standard Error|Mean
1350683|NCT01787591|Primary|Cmax|Maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal||||umol/L||Standard Error|Mean
1350684|NCT01787591|Primary|Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)||0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal||||umol/L x h||Standard Error|Mean
1350685|NCT01787461|Secondary|Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)|Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||micrometer||Standard Deviation|Mean
1350686|NCT01787461|Secondary|Change From Baseline in Skin Thickness at Week 6, 12,18 and 24|Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."|||micrometer||Standard Deviation|Mean
1350904|NCT01785186|Secondary|Time to First Negative Culture on Liquid and Solid Media|Time to a convert to a single negative culture on liquid and solid media|0 - 12 weeks|||||||
1350687|NCT01787461|Secondary|Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24|Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||gram per square meter per hour||Standard Deviation|Mean
1350688|NCT01787461|Secondary|Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24|DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||microsecond||Standard Deviation|Mean
1350689|NCT01787461|Secondary|Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24|Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands – discoloration) and Body – Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
1350690|NCT01787461|Secondary|Participants Improvement Assessment of Face at Week 12 and 24|Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
1350691|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24|Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."|||units on scale||Standard Deviation|Mean
1350692|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24|Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or “bags” under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
1350693|NCT01787461|Secondary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
1350694|NCT01787461|Secondary|Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24|IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Week 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||units on scale||Standard Deviation|Mean
1350752|NCT01786876|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Full Range|Median
1350695|NCT01787461|Primary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
1350696|NCT01787383|Secondary|Convenience TSQM|Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
1350697|NCT01787383|Secondary|Global Satisfaction TSQM|Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
1350698|NCT01787383|Secondary|Side Effects TSQM|Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
1350699|NCT01787383|Secondary|Effectiveness Satisfaction Questionnaire for Medication (TSQM)|Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
1350700|NCT01787383|Secondary|Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment||||percentage reduction in number of AKs||Standard Deviation|Mean
1350701|NCT01787383|Secondary|Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as percentage of participatns with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment||||percentage of participants|||Number
1350702|NCT01787383|Secondary|Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as percentage of participants with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment||||percentage of participants|||Number
1350703|NCT01787383|Primary|Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area|"Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together Per Arm. Each subject could contribute with up to 2 values (1 for each treated area)."|3 days after treatment of each selected treatment area||||units on a scale||Standard Deviation|Mean
1350704|NCT01787279|Secondary|Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72|Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. Participants available at the time of assessment were included in the analysis.|||Percentage of participants|||Number
1350705|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48|Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive.|At Screening and Week 48|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. ‘n’=number of evaluable participants available at specified time point.|||Percentage of participants|||Number
1350706|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72|Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
1350707|NCT01787279|Primary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 72|Safety analysis population is defined to include only participants who receive at least one dose of study medication and have one subsequent post baseline safety assessment.|||Participants|||Number
1350708|NCT01787279|Primary|Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72|Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
1350709|NCT01787279|Primary|Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported.|At Week 72|Intent-to-treat (ITT) population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
1350710|NCT01787240|Other Pre-specified|Effects of Acute Tryptophan Depletion on Serotonin Binding|"We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test.~Data were not collected"|Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)|Data were not collected||||||
1350711|NCT01787240|Secondary|Effects of Acute Tryptophan Depletion on Mood|"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.~The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.~A negative change value refers to a decrease in HAM D score."|Baseline, Visit 5 (4 weeks into study)|Patients who were randomized to take placebo or active drug|||units on a scale||Standard Deviation|Mean
1350712|NCT01787240|Secondary|Effects of Acute Tryptophan Depletion on Mood|"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.~The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.~A negative change value refers to a decrease in HAM D score."|Baseline, Visit 10 (after 9 weeks in study)|Participants assigned to take either active drug or placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.|||units on a scale||Standard Deviation|Mean
1350713|NCT01787240|Primary|Feasibility|We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).|This would occur at the first study visit (screening).||||percent of eligible patients|||Number
1350714|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350715|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350716|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350753|NCT01786876|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents/ml||Standard Deviation|Mean
1350717|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350718|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350719|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350720|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350721|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350722|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350754|NCT01786876|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents*h/ml||Standard Deviation|Mean
1350723|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350724|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350725|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350726|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350727|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350728|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350755|NCT01786876|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Standard Deviation|Mean
1350960|NCT01783743|Primary|TT Cases Screened Positive by CTA's and Confirmed by Graders|"All the TT cases detected in control versus intervention arms (adjusted for population size) through screening were verified by graders.~Grader re-graded all these cases except for the cases lost to follow-up."|10 months||||Participants|||Count of Participants
1350729|NCT01787188|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1350730|NCT01787175|Secondary|Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. . The secondary outcome evaluated participants’ recommendation about future monitoring of patient conditions. Participants reviewed a total of 10 patient cases and received a score of 0 or 1 point for each issue within each case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent a greater proportion of appropriate monitoring recommendations made.|10 minutes||||proportion||95% Confidence Interval|Mean
1350731|NCT01787175|Primary|Accuracy of Written Assessment and Plan in Terms of Control and Status|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. The primary outcome evaluated participants’ recommendations for treatment of patient conditions. Participants reviewed a total of 10 patient cases and received a score between 0 and 3 points for each issue within each patient case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent greater accuracy of the written assessment and plan.|10 minutes||||units on a scale||95% Confidence Interval|Mean
1350732|NCT01787175|Primary|Amount of Time to Complete Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.|10 minutes|58 providers were enrolled|||minutes||Standard Deviation|Mean
1350733|NCT01787032|Secondary|Terminal Half-life of BI 113608 in Plasma (t1/2)|This outcome measure presents terminal half-life of BI 113608 in plasma.|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||hours (h)||Geometric Coefficient of Variation|Geometric Mean
1350734|NCT01787032|Secondary|Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)|This outcome measure presents time from dosing to maximum measured concentration of BI 113608 in plasma.|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||hours (h)||Geometric Coefficient of Variation|Geometric Mean
1350735|NCT01787032|Secondary|Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|"This outcome measure presents area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to infinity.~The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).~Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||nanomol*hours/litre (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1350736|NCT01787032|Primary|Maximum Measured Concentration of BI 113608 in Plasma (Cmax)|"This outcome measure presents the maximum measured concentration of BI 113608 in plasma.~The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).~Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||nanomol/litre (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1350737|NCT01787032|Primary|Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|"This outcome measure presents the area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to the last quantifiable data point.~The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).~Statistical analysis 1: The ratio (Other) is calculated as BI+K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||nanomol*hours/litre (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1350738|NCT01786993|Primary|Percentage of Non-responders With MPP Compared to Biventricular Pacing|"The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient’s CCS was classified as worsened, improved or unchanged based on the definitions below:~Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation~Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.~Unchanged - patient was neither improved nor worsened~For patients who were responders at the 3-month visit, those who were “Improved” and “Unchanged” between 3 and 9 months were classified as responders, whereas those who were “Worsened” were grouped together as non-responders."|3 months to 9 months||||percentage of patients|||Number
1350739|NCT01786993|Primary|Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion|A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.|Implant to 9 months|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).|||Event-Free Probability||95% Confidence Interval|Number
1350740|NCT01786954|Secondary|Adverse Events|The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.|postoperative day #1|Adverse events were analyzed for all enrolled patients, in contrast to IOP measurements, which were only analyzed for the 50 post-vitrectomy patients.|||adverse events|||Number
1350741|NCT01786954|Primary|Measurement of Intraocular Pressure|The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.|postoperative day #1|Of the 68 patients enrolled, only 50 patients who received IOP measurement one day following vitrectomy surgery were analyzed. Those with IOP measurement following non-vitrectomy surgery were subsequently excluded from the analysis.|||mm Hg||Standard Deviation|Mean
1350742|NCT01786902|Other Pre-specified|Changes in Anti-growth Hormone Antibody||baseline and 26 weeks||||ng/mL||Standard Deviation|Mean
1350743|NCT01786902|Secondary|Changes in Height Standard Deviation Score After 26 Weeks|The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.|26 weeks||||ratio||Standard Deviation|Mean
1350744|NCT01786902|Primary|Annualized Height Velocity(cm/Year) After 26 Weeks|Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.|26 weeks||||cm/year||Standard Deviation|Mean
1350745|NCT01786876|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||percentage of radioactivity||Standard Deviation|Mean
1350746|NCT01786876|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||percentage of radioactivity||Standard Deviation|Mean
1350747|NCT01786876|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Standard Deviation|Mean
1350748|NCT01786876|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Full Range|Median
1350749|NCT01786876|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents/ml||Standard Deviation|Mean
1350750|NCT01786876|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents*h/ml||Standard Deviation|Mean
1350751|NCT01786876|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Standard Deviation|Mean
1350984|NCT01783678|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
1350756|NCT01786876|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Full Range|Median
1350757|NCT01786876|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg/ml||Standard Deviation|Mean
1350758|NCT01786876|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg*h/ml||Standard Deviation|Mean
1350759|NCT01786707|Secondary|The Number of Subjects With a Reduction of >1% in HbA1c||at 1 year||||Participants|||Count of Participants
1350760|NCT01786707|Primary|Number of Participants With a Reduction of HbA1c of >0.5%||1 year||||Participants|||Count of Participants
1350761|NCT01786668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350762|NCT01786668|Secondary|Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]).|Baseline, Week 12|FAS|||Units on a scale||Standard Error|Least Squares Mean
1350763|NCT01786668|Secondary|Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS|||Units on a scale||Standard Error|Least Squares Mean
1350764|NCT01786668|Secondary|Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12|Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||cm||Standard Error|Least Squares Mean
1350765|NCT01786668|Secondary|Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12|This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Swollen Joints||Standard Error|Least Squares Mean
1350766|NCT01786668|Secondary|Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History|Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).|Baseline, Week 12 and Follow-up|FAS - n=number of participants completing the Specific Medical History Assessment at each visit.|||Percentage of Participants|||Number
1350767|NCT01786668|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12|Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350768|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12|BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350769|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12|BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350770|NCT01786668|Secondary|Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
1350771|NCT01786668|Secondary|Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350772|NCT01786668|Secondary|Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12|The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
1350773|NCT01786668|Secondary|Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12|The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
1350774|NCT01786668|Secondary|Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12|The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
1350775|NCT01786668|Secondary|Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12|The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350776|NCT01786668|Secondary|Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12|ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
1350777|NCT01786668|Secondary|Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12|ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit.|||Percentage of participants|||Number
1350787|NCT01786551|Primary|Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.|||ng/mL||Standard Deviation|Mean
1350778|NCT01786668|Secondary|Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12|Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350779|NCT01786668|Secondary|Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12|SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350780|NCT01786668|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12|SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
1350781|NCT01786668|Secondary|Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 2, Week 4, Week 8|FAS - n=number of responders at each visit.|||Percentage of participants|||Number
1350782|NCT01786668|Primary|Percentage of Participants Achieving ASAS20 at Week 12|The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 12|FAS|||Percentage of participants|||Number
1350783|NCT01786668|Primary|Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12|The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Week 12|Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo).|||Percentage of participants|||Number
1350784|NCT01786629|Primary|"Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent)"||Day of colonoscopy|The analysis population contains subjects that consumed any portion of their bowel preparation. Subject who discontinued from the study for reasons other safety of efficacy are not included (e.g. insurance issues).|||percentage of subjects|||Number
1350785|NCT01786551|Secondary|Post-prandial Insulin Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.|||uU/ml||Standard Deviation|Mean
1350786|NCT01786551|Secondary|Post-prandial Glucose Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.|||mg/dl||Standard Deviation|Mean
1350788|NCT01786330|Primary|Worst Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Worst pain level is reported as means for each participant group."|24 hours postoperative||||units on a scale||Standard Deviation|Mean
1350789|NCT01786330|Primary|Average Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Reported average pain level is reported as means for each participant group."|24 hours postoperative||||units on a scale||Standard Deviation|Mean
1350790|NCT01786330|Primary|Lowest Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Lowest pain level is reported as means for each participant group."|24 hours postoperative||||units on a scale||Standard Deviation|Mean
1350791|NCT01786330|Secondary|Change in Hemoglobin Concentration|Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.|24 hours from baseline||||g/dL||Standard Deviation|Mean
1350792|NCT01786252|Primary|Expression of hCG Target C3 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media||||D-HSCORE||Standard Deviation|Mean
1350793|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media||||D-HSCORE||Standard Deviation|Mean
1350794|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media||||D-HSCORE||Standard Deviation|Mean
1350795|NCT01786252|Primary|Endometrial Staging in hCG Versus Vehicle Treated Patients|All H&E-stained endometrial biopsies were analyzed in a blinded manner for endometrial dating and glandular and stromal development. Criteria for endometrial dating included the presence or absence of sub-nuclear vacuoles, which is one of the more reproducible features of the Noyes dating criteria. For the purposes of statistical analysis, the most advanced elements in each of the two endometrial compartments were considered. Data are specifically reported as days post-ovulation induction.|2 days following infusion of hCG or IVF media||||days||Standard Error|Mean
1350796|NCT01786239|Primary|Treatment Response|The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms.|16 weeks||||units on a scale||Standard Error|Least Squares Mean
1350797|NCT01786174|Secondary|Forced Expiratory Volume in 1 Second (FEV1) / Slow Vital Capacity (SVC) Ratio|"Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.~Slow Vital Capacity (SVC): Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal."|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.|||Percentage of predicted max value||95% Confidence Interval|Mean
1350798|NCT01786174|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.|||Percentage of predicted max value||95% Confidence Interval|Mean
1350799|NCT01786174|Primary|Change in Slow Vital Capacity Score (SVC)|The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.|Week 0, Week 2, Week 4 and Week 8||||Percentage of predicted max value||95% Confidence Interval|Mean
1350800|NCT01786174|Primary|ALSFRS-R Total Score at Weeks 0, 2, 4 and 8|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 4 and Week 8|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.|||scores on a scale||95% Confidence Interval|Mean
1350801|NCT01786174|Secondary|Lymphocyte (T-Cell) Subset Trajectories|Gilenya (fingolimod) has been shown to successfully reduce circulating lymphocytes (a type of white blood cell) by blocking their egress (exit) from the lymph nodes. A secondary objective of the study is to quantify the effect of the treatment on circulating lymphocyte populations in patients with ALS.|Week 0, Week 2, and Week 4||||10^3/uL||95% Confidence Interval|Mean
1350802|NCT01786161|Secondary|Vancomycin Concentration at 24 Hours|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|24 hours||||mcg/mL||Standard Deviation|Mean
1350805|NCT01786109|Secondary|Post-Treatment Sensory Threshold for First Perception of Gas|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis|||mm Hg||Standard Deviation|Mean
1350806|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Sensation|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis|||mm Hg||Standard Deviation|Mean
1350807|NCT01786109|Secondary|Postprandial Colonic Motility Index|Colonic phasic pressure activity is summarized as a motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1]. A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostat balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis|||log mm Hg||Standard Deviation|Mean
1350808|NCT01786109|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|After 12 hour fast, before drug administered|Intention-to-treat analysis|||mL||Standard Error|Mean
1350809|NCT01786109|Secondary|Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions|The sensory rating was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|1 hour after drug was ingested|Intention-to-treat analysis|||mm||Standard Error|Mean
1350810|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Perception of Pain|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis|||mm Hg||Standard Deviation|Mean
1350811|NCT01786109|Secondary|Postprandial Change in Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis|||mL||Standard Error|Mean
1350812|NCT01786109|Primary|Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2)|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.~After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after drug was ingested|Intention-to-treat analysis|||mL/mm Hg||Standard Error|Mean
1350813|NCT01785875|Primary|Change From Baseline in Blood Pressure|Blood pressure (BP) values were taken post-hemodialysis assessments.|Baseline and Weeks 24 and 48|Participants who received at least 1 dose of etelcalcetide and with available data at each time point (indicated by n)|||mmHg||Standard Error|Mean
1350814|NCT01785875|Secondary|Percent Change From Baseline in Mean Phosphorus During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
1350815|NCT01785875|Secondary|Percent Change From Baseline in Mean Phosphorus During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
1350816|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
1350817|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
1350818|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
1350819|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
1350820|NCT01785875|Secondary|Percent Change From Baseline in Mean PTH During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
1350821|NCT01785875|Secondary|Percent Change From Baseline in Mean PTH During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
1350822|NCT01785875|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12||Week 46 to 53|Participants with predialysis PTH assessment during the EAP12|||percentage of participants||95% Confidence Interval|Number
1350823|NCT01785875|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP||Baseline and the efficacy assessment phase|Participants with predialysis PTH assessment during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide|||percentage of participants||95% Confidence Interval|Number
1351332|NCT01780506|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
1350824|NCT01785875|Secondary|Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12|The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.|Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with pre-dialysis PTH assessment at baseline and during EAP12|||percentage of participants||95% Confidence Interval|Number
1350825|NCT01785875|Secondary|Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase|The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.|Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)|Participants with pre-dialysis PTH assessment at baseline and during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide.|||percentage of participants||95% Confidence Interval|Number
1350826|NCT01785875|Primary|Number of Participants Who Developed Anti-etelcalcetide Antibodies|A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.|Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit|Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.|||participants|||Number
1350827|NCT01785875|Primary|Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4|Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.|52 weeks|All participants who received at least 1 dose of etelcalcetide.|||participants|||Number
1350828|NCT01785875|Primary|Number of Participants With Adverse Events (AEs)|Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.|From first dose until 30 days after last dose; the treatment period was 52 weeks.|All participants who received at least 1 dose of etelcalcetide.|||participants|||Number
1350829|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Deviation|Mean
1350830|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
1350831|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
1350832|NCT01785849|Secondary|Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase||Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
1350833|NCT01785849|Secondary|Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|Participants who had no scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set|||percentage of participants|||Number
1350834|NCT01785849|Primary|Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase|Participants who did not have any scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|The full analysis set, consisting of all randomized participants|||percentage of participants|||Number
1350835|NCT01785628|Other Pre-specified|Change in Brain Imaging by [99mTc]TRODAT-1 From Baseline to 8 Weeks.|[99mTc]TRODAT-1 : 7 patients for treatment and placebo groups, respectively.|baseline to 8 weeks|||||||
1350836|NCT01785628|Other Pre-specified|Change in Brain Imaging by 18F-FDG PET From Baseline to 8 Weeks.|18F-FDG PET scan : 8 patients for treatment and placebo groups,respectively.|baseline to 8 weeks|||||||
1350837|NCT01785628|Secondary|Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.|The PDQ-39 contains 39-items covering 8 discrete dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each question is scored on a 5-point scale and recoded to 0 to 4 for the analysis. The total score can range from 0 to 132 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
1350838|NCT01785628|Secondary|Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.|The BDI-II is a 21-item self-report questionnaire assessing the current severity of depression symptoms. Each item is scored on a scale of 0 to 3 and the total score ranges from 0 to 63. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
1350839|NCT01785628|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.|The HAM-D is a 21-item rating scaled which includes an emphasis on behavioral symptoms and somatic complaints that neglects self-reported feelings of distress; and an intermingling of frequency and intensity of symptoms. The total score ranges from 0 to 64: ten items are ranked on a scale from 0 to 4; 9 items are ranked 0 to 2; and 2 items are ranked 0 to 3. With a higher score indicating more severe symptoms.|baseline to 8 weeks||||Scores on a scale||Standard Deviation|Mean
1351365|NCT01779648|Primary|Rate of Deep Vein Thrombosis|Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.|On 4th postoperative days after total knee replacement arthroplasty|One participant of Group SF dropped out of the analysis due to the device error; air leakage in the closed circuit system.|||participants|||Number
1350840|NCT01785628|Secondary|Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.|The Behave-AD includes the assessment of symptoms and a global rating of caregiver distress. A total of 25 symptoms in 7 clusters are rated: paranoid and delusional ideation, hallucinations, aggressiveness, activity disturbances, diurnal rhythm disturbances, affective disturbances and anxieties, and phobias. Caregivers rate behavioral symptoms over the preceding 2 weeks on a 0 to 3 scale. The caregiver also determines a global assessment of caregiver distress on a scale of 0 to 3. The maximum score is 75 and with a higher score indicating more severe symptoms.|baseline to 8 weeks||||Scores on a scale||Standard Deviation|Mean
1350841|NCT01785628|Secondary|Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.|The NPI scale has 12 domains: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The total score ranges from 0 to 144, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
1350842|NCT01785628|Secondary|Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.|The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
1350843|NCT01785628|Secondary|Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.|The Cognitive Abilities Screening Instrument (CASI) has a score range of 0 to 100 and provides quantitative assessment on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment. With a higher score indicating Symptom improvement.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
1350844|NCT01785628|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline to 8 weeks. The UPDRS score has three parts, part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Each consisting of questions answered on a 0-4 point scale. The minimum total score possible is 0 and the maximum total score possible is 176. Higher scores indicating more severe symptoms.|baseline to 8 weeks.|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.|||Scores on a scale||Standard Deviation|Mean
1350845|NCT01785615|Secondary|Mean Plasminogen Activator Inhibitor-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
1350846|NCT01785615|Secondary|Mean Leptin in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||pg/ml||Standard Deviation|Mean
1350847|NCT01785615|Secondary|Mean Hs-C Reactive Protein in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
1350848|NCT01785615|Secondary|Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.|0 weeks||||ratio||Standard Deviation|Mean
1350849|NCT01785615|Secondary|Mean Apolipoprotein B in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
1350850|NCT01785615|Secondary|Mean Apolipoprotein A-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
1350851|NCT01785615|Secondary|Mean Vascular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
1350852|NCT01785615|Secondary|Mean Diastolic Blood Pressure|Measured with a blood pressure cuff|0 weeks||||mm Hg||Standard Deviation|Mean
1350853|NCT01785615|Secondary|Mean Systolic Blood Pressure|Measured with a blood pressure cuff|0 weeks||||mm Hg||Standard Deviation|Mean
1351366|NCT01779440|Secondary|Number of Participants With Biologically Confirmed Abstinence|Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm|14 weeks|Participants who attended the follow-up assessment|||Participants|||Count of Participants
1350854|NCT01785615|Secondary|Mean Intercellular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
1350855|NCT01785615|Secondary|Mean High Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
1350856|NCT01785615|Secondary|Mean Fasting Blood Glucose in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
1350857|NCT01785615|Secondary|Mean Myeloperoxidase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
1350858|NCT01785615|Secondary|Mean Triglycerides in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
1350859|NCT01785615|Secondary|Mean Low Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
1350860|NCT01785615|Secondary|Mean Waist Circumference|Waist circumference was measured with a ruler tape.|week 0||||inches||Standard Deviation|Mean
1350861|NCT01785615|Primary|Mean Myeloperoxidase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
1350862|NCT01785615|Primary|Mean Plasminogen Activator Inhibitor-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
1350863|NCT01785615|Primary|Mean Soluble Vascular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
1350864|NCT01785615|Primary|Mean Soluble Intercellular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
1350865|NCT01785615|Primary|Mean Leptin in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||pg/ml||Standard Deviation|Mean
1350866|NCT01785615|Primary|Mean Alanine Aminotransferase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||units/L||Standard Deviation|Mean
1350867|NCT01785615|Primary|Mean Aspartate Aminotransferase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||units/L||Standard Deviation|Mean
1350868|NCT01785615|Primary|Mean Fasting Plasma Glucose in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
1350869|NCT01785615|Primary|Mean High Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
1350870|NCT01785615|Primary|Mean Diastolic Blood Pressure|Measured with a blood pressure cuff|6 weeks||||mm Hg||Standard Deviation|Mean
1350871|NCT01785615|Primary|Mean Systolic Blood Pressure|Measured with a blood pressure cuff|6 weeks||||mm Hg||Standard Deviation|Mean
1350872|NCT01785615|Primary|Mean Waist Circumference|Waist circumference was measured with a ruler tape.|6 weeks||||inches||Standard Deviation|Mean
1350873|NCT01785615|Primary|Mean High Sensitivity C-reactive Protein in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated|6 weeks||||ng/dl||Standard Deviation|Mean
1350874|NCT01785615|Primary|Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.|6 weeks||||ratio||Standard Deviation|Mean
1350875|NCT01785615|Primary|Mean Apolipoprotein B in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
1350876|NCT01785615|Primary|Mean Triglycerides in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
1350877|NCT01785615|Primary|Mean Low Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
1350878|NCT01785602|Secondary|Change From Baseline in Eczema Area and Severity Index|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 – 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 4 weeks, 8 weeks|All randomized participants|||Score on a scale||Standard Error|Mean
1350879|NCT01785602|Primary|Change From Baseline in Eczema Area and Severity Index (EASI)|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 – 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 12 weeks|All randomized participants|||Score on a scale||Standard Error|Mean
1350880|NCT01785524|Secondary|Change In Vascular Function|Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)|Baseline and 16 weeks|participants who completed study|||change % dilation|||Number
1350881|NCT01785524|Secondary|Change in Angiogenesis|Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups.|Baseline and 16 weeks|participants who underwent the gastrocnemius muscle biopsies|||ratio of capillaries to muscle fibres||Standard Deviation|Mean
1350882|NCT01785524|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks||||feet||Standard Deviation|Mean
1350883|NCT01785524|Primary|Change in Exercise Capacity - Claudication Onset Time (COT)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)|Baseline & 16 Weeks||||seconds||Standard Deviation|Mean
1350886|NCT01785472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|baseline, 8 weeks|Safety Set (SAF): All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment they received.|||Participants|||Number
1350887|NCT01785472|Secondary|Number of Responders|Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline)|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments|||Participants|||Number
1350888|NCT01785472|Secondary|Change From Baseline in Ambulatory Pulse Pressure|Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
1350889|NCT01785472|Secondary|Number of Patients Achieving Successful Blood Pressure Control|Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||Number of participants|||Number
1350890|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
1350891|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
1350892|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
1350893|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
1350894|NCT01785472|Secondary|Change From Baseline in Mean 24-hour Ambulatory Blood Pressure|In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study.|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Error|Least Squares Mean
1350895|NCT01785472|Secondary|Change From Baseline in Office Pulse Pressure (msPP)|Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Least Squares Mean
1350896|NCT01785472|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Mean
1350897|NCT01785472|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Least Squares Mean
1350898|NCT01785472|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Least Squares Mean
1350905|NCT01785186|Secondary|Pharmacodynamics Including AUC0‐24/MIC (h*ng/mL) and Cmax/MIC (ng/mL)|By combining pharmacokinetic parameters and MIC values (see below), the pharmacodynamic indices AUC0‐24/MIC (h*ng/mL) and Cmax/MIC (ng/mL) will be calculated for individual patients for experimental drugs administered. Pharmacokinetic parameters and pharmacodynamic indices will be related to efficacy and safety/tolerability endpoints.|0 - 12 weeks|||||||
1350906|NCT01785186|Secondary|Pharmacokinetics Including AUC, Cl, t1/2, Vd, and Protein Binding|"Pharmacokinetic parameters will be assessed for rifampicin, moxifloxacin and SQ109:~area under the plasma concentration curve from dosing to the end of the dosing interval (AUC 0‐24) (in h*ng/mL)~the observed maximum concentration (Cmax( (in ng/mL)~time to reach Cmax (Tmax)(in hours)~the minimum observed plasma concentration 24 hours following the last dose (Cmin) (in hours),~clearance (Cl) (in mL/minute),~volume of distribution (Vd) (in L),~elimination half‐life (T1/2,) (in hours)~free (protein‐unbound) fraction (for rifampicin only) (in percent)."|0 - 12 weeks|Pharmacokinetic population|||Rifampicin AUC(mg*h/l)||Full Range|Geometric Mean
1350907|NCT01785186|Secondary|Mycobacteriology Identification and Characterization by PCR and MIC|"Cultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed as follows:~Identification of M. tuberculosis complex and RIF resistance by PCR (GeneXpert MTB/RIF®),~First-line drug susceptibility testing of the M. tuberculosis isolates using the MGIT system for sensitivity to rifampicin; isoniazid, pyrazinamide, moxifloxacin or ethambutol.~Minimum inhibitory concentrations (MIC) of SQ109, rifampicin and moxifloxacin.~Typing of the infecting strain(s) by molecular methods."|0 - 12 weeks|||||||
1350908|NCT01785186|Secondary|Frequency of Adverse Events|All Adverse Events (AE), and AEs considered to be drug-related will coded using standard AE dictionaries.|0 - 12 weeks||||participants|||Number
1350909|NCT01785186|Primary|Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media|From enrollment, the time to stable culture conversion (2 consecutive negative weekly cultures) in liquid media.|0 - 12 weeks|Modified intention to treat analysis|||days||Inter-Quartile Range|Median
1350910|NCT01785160|Primary|Cmax ,ss|"C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for ‘subject’ and ‘treatment’.~RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1350911|NCT01785160|Primary|AUC( Tau,ss)|"AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for ‘subject’ and ‘treatment’.~RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1350912|NCT01785134|Secondary|Blood Lipids||2 years postoperative||||P-Cholesterol mmol/L||Standard Deviation|Mean
1350913|NCT01785134|Secondary|Body Mass Index at 2 Years||2 years postoperative||||Kg/meter squared||Standard Deviation|Mean
1350914|NCT01785134|Secondary|Blood Pressure at 2 Years||2 years postoperative||||mm Hg systolic||Standard Deviation|Mean
1350915|NCT01785134|Secondary|Body Composition at Two Years||2 years postoperative||||% body fat||Standard Deviation|Mean
1350916|NCT01785134|Primary|Insulin Sensitivity at 2 Years|Insulin sensitivity measured by hyperinsulinemic euglycemic clamp|2 years postoperative||||glucose/kg body weight/min||Standard Deviation|Mean
1350917|NCT01785095|Secondary|Total Dose of FSH Units Used.||after 2 weeks of treatment||||IU||Standard Deviation|Mean
1350918|NCT01785095|Secondary|Number of Oocytes Retrieved|the number of oocytes retrieved in the first cycle and in the second cycle are compared.|after 2 weeks of treatment||||oocytes||Standard Deviation|Mean
1350919|NCT01785095|Primary|Number of Patients Producing Anti-FSH Antibodies.|The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.|4 months.|presence of Antibodies against FSH|||participants|||Number
1350920|NCT01784965|Secondary|Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction|Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.|Baseline, 14 weeks||||mg/dL||Standard Deviation|Mean
1350921|NCT01784965|Secondary|Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H|Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks|Baseline, 14 weeks||||pmol/l x4 h||95% Confidence Interval|Mean
1350922|NCT01784965|Primary|Change in Weight Reported at 14 Weeks|Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.|Baseline and 14 weeks||||kg||95% Confidence Interval|Mean
1350923|NCT01784770|Secondary|Clinical Effectiveness Rate in Participants|Clinical effectiveness rate in participants, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."|||Percentage of Participants||95% Confidence Interval|Number
1350924|NCT01784770|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.|29 days|The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.|||Participants|||Number
1350925|NCT01784666|Primary|Change in MADRS (4 Weeks)|"Change in Montgomery-Asberg Depression Rating Scale (MADRS) in isradipine-treated epochs versus placebo-treated epochs.~These scores represent total scores, and on the MADRS total scores range from 0-60. A higher score indicates increased depression severity."|Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4)||||scores on a scale|||Number
1350926|NCT01784614|Secondary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.|||nanograms•hour/milliliter (ng•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1350927|NCT01784614|Secondary|PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1350928|NCT01784614|Secondary|Total Sleep Time (TST)|TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.|||min||90% Confidence Interval|Least Squares Mean
1350929|NCT01784614|Secondary|Latency to Persistent Sleep (LPS)|LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.|||min||90% Confidence Interval|Geometric Mean
1350930|NCT01784614|Primary|Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo|WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.|||minutes (min)||90% Confidence Interval|Geometric Mean
1350931|NCT01784055|Primary|Procedure Success|To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure|The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.||||Participants|||Count of Participants
1350932|NCT01783938|Secondary|Investigator-assessed Rate of Progression|The progression rate at a specific timepoint is defined as the number of participants who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of randomized participants. As specified by modified RECIST 1.1, the evaluation of PD at Week 13 and Week 25 used the baseline tumor assessment as reference. For purposes of the primary analysis of progression rates, if a treated participant were missing his/her tumor assessment at the specified study week, then the results of the previous tumor response evaluation were to be carried forward. Both clinical and radiological progressions were counted as a progression outcome. A participant who died without a reported prior progression was considered to have progressed on the date of his/her death. Deaths before or at Week 13 are counted as progression outcome. Confidence interval based on the Clopper and Pearson method.|Week 13; Week 25|All treated participants; All participants who received at least one dose of any study therapy.|||percentage of participants||95% Confidence Interval|Number
1350933|NCT01783938|Secondary|Investigator-assessed Duration of Response (DOR)|Duration of response (DOR) was performed to further characterize the response rate at Week 25. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR was assessed for participants with confirmed response at Week 25. Median computed using Kaplan-Meier product-limit method.|Week 25 up to date of disease progression or death, up to approximately 2 years|All treated participants with confirmed response at week 25; Participants were censored at their last assessment date if response was not changed.|||months||95% Confidence Interval|Median
1351367|NCT01779440|Primary|Number of Participants Who Utilized Smoking Cessation Treatment|Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.|14 week follow-up||||Participants|||Count of Participants
1350934|NCT01783938|Secondary|Investigator-assessed Response Rate at Week 25|Response rate is defined as the number of participants who have a complete response (CR) or partial response (PR) at Week 25 per modified RECIST 1.1 criteria, with confirmation on the scheduled scan at Week 33 (or any subsequent scan performed at least 4 weeks after the Week 25 scan), divided by the total number of treated participants. Results of the tumor assessment at Week 13 or any unscheduled tumor assessment obtained prior to Week 25, except for baseline/screening tumor assessment, were not considered in the assessment of response rate at Week 25. Any treated participant without an evaluable Week 25 time point response (per modified RECIST 1.1) was considered a non-responder for primary analysis of response rate at Week 25. Evaluations occurring after the dates of subsequent anticancer therapy were not included when determining or confirming response at Week 25. Confidence interval based on the Clopper and Pearson method.|Week 25|All treated participants; All participants who received at least one dose of any study therapy.|||percentage of participants||95% Confidence Interval|Number
1350935|NCT01783938|Primary|Percentage of Participants With Treatment-related Grade 3-5 Adverse Events (AEs) During the Induction Periods|The rate or percentage of participants with treatment-related grade 3-5 AEs is defined as the number of participants who experienced at least 1 treatment related Grade 3 - 5 adverse event (AE) per NCI CTCAE version 4.0 criteria, any preferred term with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. AEs with an onset date after start date of Continuation Period or start of subsequent anti-cancer therapy were not included. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to Week 25|All treated participants; All participants who received at least one dose of any study therapy.|||percentage of participants||95% Confidence Interval|Number
1350936|NCT01783912|Primary|Acceptance of Wisconsin Tobacco Quit Line Services|The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.|4-6 weeks after study enrollment||||participants|||Number
1350937|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to week 52|FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1350938|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to week 52|FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1350939|NCT01783886|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline up to week 52|FAS with assessment for this outcome measure.|||micrometer||Standard Deviation|Mean
1350940|NCT01783886|Secondary|Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF|ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to week 52|FAS.|||Percentage of participants|||Number
1350941|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.|||Percentage of participants|||Number
1350942|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.|||Percentage of participants|||Number
1350943|NCT01783886|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.|Baseline up to week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA. FAS with assessment for this outcome measure.|||Letters correctly read||Standard Deviation|Mean
1350944|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 37 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (37 days) minus earliest time point.|baseline and 37 days later||||units on a scale||Standard Deviation|Mean
1351368|NCT01779219|Secondary|Time|the preparation (Tprep), operation (Top) and total operating room (TOR) time|From moment of the transfer to the OR until the moment of transfer out of it, assessed on the day of operation.||||minutes||Standard Deviation|Mean
1350945|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 31 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (31 days) minus earliest time point.|baseline and 31 days later||||units on a scale||Standard Deviation|Mean
1350946|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 7 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (7 days) minus earliest time point.|baseline and 7 days later||||units on a scale||Standard Deviation|Mean
1350947|NCT01783860|Primary|Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.|zero time and 61 days later||||units on a scale||Standard Deviation|Mean
1350948|NCT01783860|Secondary|Main Ocular Signs|lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment were measured. For each items there was a question with scale form zero to three (zero for no sign to three for maximum sign). Therefore, maximum score for signs was 21 (worse outcome) and minimum score was zero (better outcome). We calculated a total score for signs. Finally, we reported a change in total score calculated as the latest time point (61 days) minus earliest time point.|Change from baseline until 61 days after treatment||||units on a scale||Standard Deviation|Mean
1350949|NCT01783860|Primary|Change of Blepharitis Symptoms Score|Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.|Change from the baseline until 61 days after treatment||||score||Standard Deviation|Mean
1350950|NCT01783821|Secondary|Intensive Care Unit (ICU) Length of Stay||Baseline to Day 28||||days||Inter-Quartile Range|Median
1350951|NCT01783821|Secondary|Hospital Length of Stay||Baseline to Day 28||||days||Inter-Quartile Range|Median
1350952|NCT01783821|Secondary|Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)|ARDS was defined per Berlin definition. Chest radiographs of all ventilated (non-invasive or invasive) patients were reviewed as consistent or not consistent with ARDS by the site investigator. A second adjudication was performed by an alternate principal investigator blinded to subject identification and clinical data. Final diagnosis of ARDS was determined centrally after chest radiograph adjudication was considered together with other relevant clinical data.|Hospital discharge, approximately day 28||||participants|||Number
1350953|NCT01783821|Secondary|Number of Subjects Who Needed Mechanical Ventilation||Hospital discharge, approximately day 28||||participants|||Number
1350954|NCT01783821|Primary|Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|The data in the table below represent the greatest change from baseline observed for any one participant over all individual post-baseline measurements.|Days 0 - 5|Intention to Treat Analysis|||participants|||Number
1350955|NCT01783821|Primary|Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. The formula for the calculation of SpO2/FiO2 (or S/F ratio) is %saturation/proportion of FiO2 concentration.|baseline to day 5 after the first treatment|Intention to Treat analysis. The patient population for each day is indicated in the category by (treatment arm, placebo arm).|||SpO2/FiO2 Ratio||Inter-Quartile Range|Median
1350956|NCT01783743|Secondary|Negative Predictive Values of TT Screening Methods|"Negative Predictive Values (NPV) of the different screening methods compared to true assessment of cases and controls.~It was calculated by using extrapolated values. Formula used : True Negatives /total participants at initial screening,screened as negative by CTA's"|10 months||||percentage of true negatives||95% Confidence Interval|Number
1350957|NCT01783743|Secondary|Positive Predictive Values of TT Screening Methods|"Positive Predictive Values (PPV) of the different screening methods compared to true assessment of cases and controls.~It was calculated by using extrapolated values. The formula used: True positives /total participants at initial screening screened as positive by CTA's."|10 months||||percentage of true positives||95% Confidence Interval|Number
1350958|NCT01783743|Secondary|Specificity of TT Screening Methods|"Specificity of different TT screening methods compared to true assessment of cases and controls using the extrapolated values from the follow-up survey.~Formula used: True negatives/(true negatives +false positive)"|10 months||||percentage of true negatives||95% Confidence Interval|Number
1350959|NCT01783743|Secondary|Sensitivity of TT Screening Methods|"Sensitivity of different TT screening methods compared to true assessment of cases and controls using the extrapolated values from the follow-up survey.~Formula used: True positives/(true positives +false negative)"|10 months||||percentage of true positives||95% Confidence Interval|Number
1350961|NCT01783730|Secondary|Percentage of Participants Achieving SDAI Remission|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. The percentage of participants with an SDAI score ≤3.3 was documented.|From baseline to 24 weeks|Participants with available data|||percentage of participants|||Number
1350962|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 24|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 24|Participants with available data|||units on a scale||Standard Deviation|Mean
1350963|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 12|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 12|Participants with available data|||units on a scale||Standard Deviation|Mean
1350964|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 4|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 4|Participants with available data|||units on a scale||Standard Deviation|Mean
1350965|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Baseline|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 0|Participants with available data|||units on a scale||Standard Deviation|Mean
1350966|NCT01783730|Secondary|Percentage of Participants Achieving CDAI Remission|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. The percentage of participants with a CDAI score ≤2.8 was documented.|From baseline to 24 weeks|Participants with available data|||percentage of participants|||Number
1350967|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 24|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 24|Participants with available data|||units on a scale||Standard Deviation|Mean
1350968|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 12|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 12|Participants with available data|||units on a scale||Standard Deviation|Mean
1350969|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 4|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 4|Participants with available data|||units on a scale||Standard Deviation|Mean
1350970|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Baseline|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 0|Participants with available data|||units on a scale||Standard Deviation|Mean
1350971|NCT01783730|Secondary|Percentage of Participants Achieving DAS28-4(ESR) Remission|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. The percentage of participants with a DAS28 score <2.6 was documented.|From baseline to 24 weeks|Participants with available data|||percentage of participants|||Number
1350972|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 24|Participants with available data|||units on a scale||Standard Deviation|Mean
1350973|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 12|Participants with available data|||units on a scale||Standard Deviation|Mean
1350974|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 4|Participants with available data|||units on a scale||Standard Deviation|Mean
1350975|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 0|Participants with available data|||units on a scale||Standard Deviation|Mean
1350976|NCT01783730|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.|From baseline through week 26|Participants who received adalimumab treatment|||participants|||Number
1350977|NCT01783678|Secondary|Percentage of Participants Experiencing Virologic Failure|"On-treatment virologic failure was defined as either:~Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline up to Posttreatment Week 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.|||percentage of participants|||Number
1350978|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
1350979|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
1350980|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
1350981|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
1350982|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
1350983|NCT01783678|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.|||percentage of participants|||Number
1351369|NCT01779219|Secondary|Length of Hospital Stay|The preoperative (LOSpre), postoperative (LOSpost) and total length of hospital stay (LOS)|From date of hospitalization until the date of discharge, assessed up to 2 days.||||days||Full Range|Median
1350985|NCT01783678|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. 1 participant with genotype 1 HCV infection did not have subtype information available.|||percentage of participants|||Number
1350986|NCT01783639|Secondary|Procedural Success|Defined as both device and angiographic success|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
1350987|NCT01783639|Secondary|Angiographic Success|Successful completion of the protected stent procedure without angiographic complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
1350988|NCT01783639|Secondary|Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks||Within 30 Days of procedure|||||||
1350989|NCT01783639|Secondary|The Rate of Access Site Complications||Within 30 Days of procedure|||||||
1350990|NCT01783639|Secondary|The Rate of Clinical Success|Defined as freedom from procedure related serious adverse events|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
1350991|NCT01783639|Secondary|The Rate of Device Success|Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
1350992|NCT01783639|Primary|The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.|Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.|Within 30 Days of procedure||||participants||95% Confidence Interval|Number
1350993|NCT01783574|Secondary|Sexual Dysfunction|Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160.|Week 8||||units on a scale||Standard Error|Mean
1350994|NCT01783574|Secondary|Fatigue|Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale.|Week 8||||units on a scale||Standard Error|Mean
1350995|NCT01783574|Primary|Depressive Symptom Severity|Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.|Week 8||||units on a scale||Standard Error|Mean
1350996|NCT01783561|Secondary|Cerebral Blood Flow|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved cerebral blood flow by near infrared spectroscopy (NIRS) in the first 24 hours of life.|first 24 hours of life|||||||
1350997|NCT01783561|Secondary|Systemic Blood Flow|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved measures of systemic blood flow (measured by superior vena cava flow)|first 24 hours||||ml/kg/min||Standard Deviation|Mean
1350998|NCT01783561|Secondary|Hypotension|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life decreases the need for inotropes for hypotension within the first 12 hours of life.|first 12 hours of life|||||||
1350999|NCT01783561|Primary|Intubation|The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants <29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at < 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.|First 12 hours of life||||participants|||Number
1351000|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.|||units on a scale||Standard Error|Least Squares Mean
1351001|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.|||units on a scale||Standard Error|Least Squares Mean
1351002|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS). Subpopulation of study participants aged 6-11 years.|||units on a scale||Standard Error|Least Squares Mean
1351003|NCT01783548|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment. Subpopulation of study participants aged 6-11 years.|||units on a scale||Standard Error|Least Squares Mean
1351004|NCT01783496|Secondary|Subject Satisfaction With Treatment Results|"subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 – Very Satisfied, 4 - Satisfied, 3 – Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 – Very Dissatisfied.~Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater (‘satisfied’ or ‘very satisfied’)."|6 months||||percentage of subjects satisfied|||Number
1351005|NCT01783496|Secondary|Improvement in Skin Laxity (Subject Self-assessed)|Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.|6 months||||units on a scale||Standard Deviation|Mean
1351006|NCT01783496|Primary|Improvement in Laxity|Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 – Very Significant Improvement (76-100%), 3 – Marked Improvement (51-75%), 2 – Moderate Improvement (26-50%), 1 – Minor/Mild Improvement (1-25%), or 0 – No Improvement.|6 months||||units on a scale||Standard Deviation|Mean
1351007|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 3-month to 6 month post-op|Subjects with completed narcotic usage assessment from 3-month to 6-month post op: 100 Suture Wire / 102 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
1351008|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 6-week to 3-month post-op|Subjects with completed narcotic usage assessment from 6-week to 3-month post op: 108 Suture Wire / 104 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
1351009|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 3-week to 6-week post-op|Subjects with completed narcotic usage assessment from 3-week to 6-week post op: 115 Suture Wire / 111 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
1351010|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From Hospital Discharge to 3-week post-op|Subjects with completed narcotic usage assessment from hospital discharge to 3-week post op: 109 Suture Wire / 112 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
1351011|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED).|Index (Day 0 to Hospital Discharge)|Subjects with completed narcotic usage assessment from Day 0 to hospital discharge: 118 Suture Wire / 114 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
1351012|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 6-month Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|6-month Post-op|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.~Subjects at 6-month post op with completed pain assessment: 96 Suture Wire / 102 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
1351013|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 3-month Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|3-month Post-op|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.~Subjects at 3-month post op with completed pain assessment 108 Suture Wire / 105 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
1351014|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 6-week Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|6-week Post-op|"Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain.~Subjects at 6-week post op with completed pain assessment: 114 Suture Wire / 112 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
1351015|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 3-week Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|3-week Post-op|"Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain.~Subjects at 3-week post op with completed pain assessment: 107 Suture Wire / 107 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
1351016|NCT01783483|Secondary|Pain Measured in a 10-point Scale at Day 7 Post Operative|"Intensity of sternal pain assessed using 10 point scale:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|Day 7|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.~Subjects at 7-Day post op with completed pain assessment: 31 Suture Wire / 30 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
1351017|NCT01783483|Primary|Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing|"Parameters for scoring:~0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome~- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular~- Early healing: Faint mineralization between non-contacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins~- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension~- Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome"|6-month post-op|Subjects with completed CT scan at 6 months post op: 100 Suture Wire / 101 SternaLock Blu)|||units on a scale 0-5||Standard Deviation|Mean
1351018|NCT01783483|Primary|Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing|"Parameters for scoring:~0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome~- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular~- Early healing: Faint mineralization between noncontacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins~- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension~- Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome"|3-month post-op|Subjects with completed CT scan at 3 month post op: 102 Suture Wire / 103 SternaLock Blu|||units on a scale||Standard Deviation|Mean
1351019|NCT01783470|Other Pre-specified|Whole-body Energy Expenditure|This is the energy expenditure as calculated using indirect calorimetry.|30 minutes before drug administration followed by 30 minutes after FDG administration|||||||
1351020|NCT01783470|Primary|BAT Activity as Measured by 18F-FDG PET/CT|difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue.|60 min after FDG administration||||mL*SUVmean*g/mL||Inter-Quartile Range|Median
1351021|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Negative affect~Score range: 0 (minimum score) - 50 (maximum score) Higher scores represent worse outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1351022|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Positive affect~Score range: 0 (minimum score) - 50 (maximum score)~High scores represent better outcomes"|baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1351023|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck youth inventories - Depression scale~Subscale range: 0 (minimum score) - 60 (maximum score)~Higher scores a worse outcome"|baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1351024|NCT01783418|Secondary|Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention|"Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score)~Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1351025|NCT01783418|Primary|Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention|"Pittsburgh Sleep Quality Index~Score range: 0 (minimum score) - 21 (maximum score)~Higher scores indicate worse outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1351026|NCT01783418|Primary|Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention|"Pediatric Cancer Quality of Life Inventory~Scale range: 0 (minimum score) to 108 (maximum score) Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1351027|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck Youth Inventory - Anxiety scale Subscale range: 0 (minimum score) - 60 (maximum score)~Higher scores indicate higher anxiety and a worse outcome"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1351370|NCT01779219|Primary|Diagnostic Yield|The diagnostic yield is expressed as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the operation.|For each patient 2 weeks after the operation||||participants|||Number
1351028|NCT01783236|Secondary|VAS Score 24 Hours Post-Operation|"24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|24 hours post-operation||||mm||Inter-Quartile Range|Median
1351029|NCT01783236|Secondary|VAS Pain Score 6 Hours Post-Operation|"6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|6 Hours Post-Operation||||mm||Inter-Quartile Range|Median
1351030|NCT01783236|Secondary|VAS Pain Score 2 Hours Post Operation|"2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|2 Hours Post Operation||||mm||Inter-Quartile Range|Median
1351031|NCT01783236|Secondary|Total Number of PCA Requests in First 24 Hours Post-Operation|The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation|24 hours post-operation||||PCA requests||Inter-Quartile Range|Median
1351032|NCT01783236|Primary|Total Morphine Consumption (mg)|How much morphine the subject consumes in the first 24 hours after surgery (mg).|24 hours||||mg||Inter-Quartile Range|Median
1351033|NCT01783080|Secondary|Social Functioning at Week 12 on the Social Adjustment Scale|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|Week 12||||unites on a scale||Standard Deviation|Mean
1351034|NCT01783080|Secondary|Social Functioning at Week Baseline on the Social Adjustment Scale|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|baseline||||unites on a scale||Standard Deviation|Mean
1351035|NCT01783080|Primary|Paid Work Hours at Week Baseline|Subject-reported paid work hours per week at week baseline|Baseline||||hours||Standard Deviation|Mean
1351036|NCT01783080|Primary|Paid Work Hours at Week 12|Subject-reported paid work hours per week at week 12|Week 12||||hours||Standard Deviation|Mean
1351037|NCT01783054|Secondary|Number of Adverse Events Reported in Subjects Enrolled.|Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0.|First study drug administration until end of study|All subjects who were administered study intervention and had documented adverse events were analyzed. The number below represents the number of adverse events, including serious adverse events, reported on by enrolled subjects. A complete list of the adverse events reported are in the adverse events tables of these results.|||adverse events|||Number
1351038|NCT01783054|Secondary|Estimate Median Overall Survival|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.|||days|||Number
1351039|NCT01783054|Secondary|Estimate Median Time to Recurrence.|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.|||days|||Number
1351040|NCT01783054|Other Pre-specified|Circulating Tumor Cells (CTC)|To evaluate and describe CTC number, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniquen from patients with pancreatic adenocarcinoma. To determine and evaluate the correlation between expression of biomarkers in CTCs and expression of biomarkers in resected tissue specimen with the same cancer patient.|From enrollment to surgery|This outcome measure was added as part of an amendment. No subjects were enrolled after this amendment was instituted, so no outcomes measures were collected.||||||
1351041|NCT01783054|Secondary|Number of Participants With R0 Resection Status.|R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor.|at time of surgery|Subjects who had surgical resection are included in the analysis for this endpoint.|||participants|||Number
1351042|NCT01783054|Primary|Tumor Response|Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen. A good response is defined as a grade III or IV histopathologic appearance, equivalent to <10% viable tumor.|at time of surgery|The study terminated early and the data for this outcome measure was not documented.||||||
1351043|NCT01783015|Secondary|Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351044|NCT01783015|Secondary|Number of Participants With Positive Etanercept Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351045|NCT01783015|Secondary|Change From Baseline in Vectra Disease Activity Levels|The change from Baseline in Vectra disease activity levels was to be estimated. The assessment measures serum protein biomarkers associated with RA. It has a range from 1-100 with lower scores indicating the better outcome.|Baseline, 12 weeks, 24 weeks|Vectra disease activity analysis of laboratory samples was not conducted due to study termination.||||||
1351046|NCT01783015|Secondary|Change From Baseline in Patient Acceptable Symptom State (PASS)|The Patient Acceptable Symptom State (PASS) was a participant-completed form in which participants were asked to “Think about all the ways your rheumatoid arthritis (RA) has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable or unacceptable to you?” The participant indicated a response of either “acceptable” or “unacceptable”.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351047|NCT01783015|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The 36-Item Short Form Health Survey (SF-36) is widely used 36-item questionnaire that measures general health-related quality of life in the following 8 domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0 to 100 where higher scores are better.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351048|NCT01783015|Secondary|Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)|The EuroQol-5 Dimensions (EQ-5D) is a participant-completed questionnaire designed to assess health related quality of life. There are 2 components to the EQ-5D: a Health State Profile and a VAS. For the Health State Profile, participants recorded their level of current health for 5 domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from the 5 domains may be used to calculate a single index value, also known as a utility score. On the VAS participants were asked to rate their current health on a scale from 0 to 100 mm, where 0 represented the “worst imaginable health state” and 100 represented the “best imaginable health state.” In addition to a summary of mean changes, 1 categorical endpoint each based on EQ-5D utility score and 1 based on the VAS were derived and analyzed: EQ-5D utility score improvement ≥0.05 and EQ-5D VAS score >82.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351049|NCT01783015|Secondary|Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351050|NCT01783015|Secondary|Change From Baseline in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351051|NCT01783015|Secondary|Change From Baseline in Subject Pain|Subject Pain was to be measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no pain and 100 mm = most severe pain.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351052|NCT01783015|Secondary|Change From Baseline in Subject General Health VAS.|Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351053|NCT01783015|Secondary|Change From Baseline in Subject Global Assessment of Disease Activity|Change from Baseline in Subject Global Assessment of Disease Activity was to be estimated. Participants were to assess their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351054|NCT01783015|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|Change from Baseline in the PGA scores was to be estimated. The Study Physician estimated the participant's overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351055|NCT01783015|Secondary|Change From Baseline in Number of Swollen Joints|Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351056|NCT01783015|Secondary|Change From Baseline in Number of Tender/Painful Joints|Change from Baseline in the number of tender/painful joints using the 28 joint count including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351057|NCT01783015|Secondary|Change From Baseline in SDAI.|Change from Baseline in SDAI scores were to be calculated. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351058|NCT01783015|Secondary|Change From Baseline in CDAI|Change from Baseline in CDAI scores was to be calculated. The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351059|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).|The SDAI is the numerical sum of five outcome parameters: TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351060|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351061|NCT01783015|Secondary|Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351062|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and ≥ 90% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351063|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and ≥ 70% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351064|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and ≥ 50% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351065|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant's assessment of pain; Subject Global Assessment (SGA) of disease activity; Physician Global Assessment (PGA) of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351066|NCT01783015|Secondary|Number of Participants With DAS28 <2.6|Number of Participants with DAS28 <2.6. A DAS28 < 2.6 implies remission.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351067|NCT01783015|Secondary|Number of Participants With DAS28 <3.2|Number of participants with DAS28 <3.2. A score of < 3.2 implied low disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351068|NCT01783015|Secondary|Change From Baseline in the DAS28 at Week 24|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the CRP and and Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351069|NCT01783015|Primary|Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
1351070|NCT01782963|Secondary|Evaluate Pharmacogenomic Markers|To evaluate pharmacogenomic markers among patients with treatment related neuropathy.|2 years||2018-06-30|06/2018||||
1351396|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Intention to Treat)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"|||microns||Standard Error|Mean
1351071|NCT01782963|Secondary|Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection|The pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.|Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose|A total of only 10 participants per arm were evaluated for drug plasma concentrations following Bortezomib administration.The number of participants vary by time-point due to missing measurements for the concentrations.|||ng/mL||Standard Deviation|Mean
1351072|NCT01782963|Secondary|Response Rate With Respect to Cytogenetic Characteristics|To evaluate the response rate with respect to cytogenetic characteristics of the bone marrow plasma cells.|2 years||2018-06-30|06/2018||||
1351073|NCT01782963|Secondary|Median Time to Response|Evaluate the time to response and response duration of modified RVD|2 years||2018-06-30|06/2018||||
1351074|NCT01782963|Secondary|Median Overall Survival|The median overall survival as measured from the start of treatment until the time of death due to any cause.|From the start of treatment until death or until 5 years after the time of disease progression|Median overall survival was not met before the end of follow-up/ data cutoff point because more than half of the participants were still alive.|||years||95% Confidence Interval|Median
1351075|NCT01782963|Secondary|Median Progression Free Survival|"The median amount of time as measured from the start of treatment until either death or progression.~Progressive disease requires 1 or more of the following:~>=25% increase from lowest response level in serum M-protein (>=0.5 g/dL absolute increase) and/or urine M-component (>=200 mg/24hr absolute increase)~>=25% increase in the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL). Only for use in patients without measurable serum and M-protein levels.~>=25% increase in bone marrow plasma cell percentage (absolute percentage >=10%)~New or increase in existing bone lesions or soft tissue plasmacytomas~Hypercalcemia (serum calcium >11.5 mg/dL) due solely to the plasma cell proliferative disorder."|From the start of treatment until death or progression or until 3 years after the last participant is enrolled||||Months||95% Confidence Interval|Median
1351076|NCT01782963|Secondary|Number of Participants With Grade 3 or Higher Treatment Related Adverse Events|A summary of the number of participants with grade 3 or higher treatment related adverse events for adverse events that had an overall incidence of greater than 15% (any grade) as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4).|2 years||||Participants|||Count of Participants
1351077|NCT01782963|Primary|Objective Response Rate|"Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following:~Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM)~CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours~PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required"|2 years||||Participants|||Count of Participants
1351078|NCT01782898|Secondary|Post Operative Pain Reported by the Subject.|Post operative pain reported by the subject as determined as area under the numeric rating scale for pain versus time curve in the post anesthesia care unit ( score*min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain over 24 hours.The range is 0 pain to x time in minutes x hour ( 60-1440 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU to 24 hours after the surgical procedure. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|24 hour||||(pain score * minutes ) in the PAC U||Inter-Quartile Range|Median
1351079|NCT01782898|Secondary|Postoperative Opioid Consumption|The total amount of opioid consumed by subject at 24 hours after surgery measured in IV morphine equivalents.|24 hours||||IV mg of morpine equivalents||Inter-Quartile Range|Median
1351080|NCT01782898|Primary|Qor-40 at 24 Hours Postoperative|"Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.~Time frame for this evaluation is 24 hours after the surgical procedure"|24 hours||||units on a scale 40 low-200 high||Inter-Quartile Range|Median
1351081|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|24 weeks||||units on a scale||Standard Deviation|Mean
1351082|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|12 weeks||||units on a scale||Standard Deviation|Mean
1351083|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|6 weeks||||units on a scale||Standard Deviation|Mean
1352113|NCT01769443|Secondary|Incidence of Administering Desensitization Therapy Beyond 90 Days After Randomization||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351084|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|24 weeks||||units on a scale||Standard Deviation|Mean
1351085|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|12 weeks||||units on a scale||Standard Deviation|Mean
1351086|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|6 weeks||||units on a scale||Standard Deviation|Mean
1351087|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|0 weeks||||units on a scale||Standard Deviation|Mean
1351088|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient’s point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|0 weeks||||units on a scale||Standard Deviation|Mean
1351089|NCT01782885|Secondary|Change in Visual Analog Scale (VAS)|The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?|0-24 weeks||||Centimeters||Standard Deviation|Mean
1351090|NCT01782872|Secondary|Middle Deltoid|A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer|24 hours after surgery|Patients who agreed to the measurements were included in the analysis.|||kgf||Inter-Quartile Range|Median
1351091|NCT01782872|Secondary|Numeric Rating Scale (NRS) Pain Scores at Rest|Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest|Preop||||units on a scale||Inter-Quartile Range|Median
1351092|NCT01782872|Secondary|Duration of Analgesia From Interscalene Nerve Block|Median time until a patient needed to take opioid pain medication|Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM|Patients who were able to provide actual or estimates of time until they first needed to use pain medication were included in this analysis.|||hours||Standard Error|Mean
1351093|NCT01782872|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the interscalene block is given||||units on a scale||Standard Deviation|Mean
1351094|NCT01782859|Secondary|Pain at 3 Months Post-op|At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.|3 months postoperatively||||units on a scale||Standard Deviation|Mean
1351095|NCT01782859|Secondary|Desmosine Level (Marker of Lung Injury)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days|Desmosine levels were not analyzed.||||||
1351096|NCT01782859|Secondary|Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days||||picograms/milliliter||Standard Deviation|Mean
1351097|NCT01782859|Primary|Plasmin-a 2 Antiplasmin Complex (PAP)||First 24 hours after surgery||||mcg/L||Standard Deviation|Mean
1351098|NCT01782859|Primary|Serum Prothrombin Fragment 1 and 2 (PF 1.2)||First 24 hours after surgery||||pmol/mL||Standard Deviation|Mean
1351099|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in Non ApoE4 Carriers|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in non ApoE4 Carriers|Baseline to Week 4|Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.|||ratio||95% Confidence Interval|Mean
1351100|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in All Subjects|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in all subjects|Baseline to Week 4|There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.|||ratio||95% Confidence Interval|Mean
1351397|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Per-Protocol)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||microns||Standard Error|Mean
1351101|NCT01782742|Secondary|Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (Non ApoE4 Carriers)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes (non ApoE4 carriers)|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels in non ApoE4 carriers. Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.|||pmol/L||95% Confidence Interval|Mean
1351102|NCT01782742|Secondary|Secondary Outcome Measuring Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (ALL SUBJECTS)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes in ALL SUBJECTS. There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.|||pmol/L||95% Confidence Interval|Mean
1351103|NCT01782742|Primary|Primary Outcome by Genotype (HOMOZYGOTE ApoE4 CARRIERS)|"This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HOMOZYGOTE ApoE4 CARRIERS)~There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."|Baseline to Week 4|"Change in composite and regional Beta Amyloid burden on Homozygote ApoE4 carriers.~There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."|||SUVr||95% Confidence Interval|Mean
1351104|NCT01782742|Primary|Primary Outcome by Genotype (HETEROZYGOTE ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HETEROZYGOTE ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on Heterozygote ApoE4 carriers|||SUVr||95% Confidence Interval|Mean
1351105|NCT01782742|Primary|Primary Outcome by Genotype (ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on ApoE4 carriers|||SUVr||95% Confidence Interval|Mean
1351106|NCT01782742|Primary|Primary Outcome by Genotype (NON ApoE4 CARRIERS)|Measures changes from baseline on treatment compared to placebo at week 4 on composite and regional Beta Amyloid burden according to ApoE genotype (NON ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid Burden on non-ApoE4 carriers|||SUVr||95% Confidence Interval|Mean
1351107|NCT01782742|Primary|Primary Outcome by Genotype (ALL SUBJECTS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers compared to E-4 non-carriers)|Baseline to Week 4|Change om composite and regional Beta Amyloid burden according to ApoE genotype on ALL SUBJECTS|||SUVr||95% Confidence Interval|Mean
1351108|NCT01782742|Secondary|Change in the Activities of Daily Living (ADCS-ADL) Score in ALL Subjects From Baseline to Week 4|The ADCS-ADL is an activities-of-daily-living inventory developed by the ADCS to assess functional performance in participants with AD (Galasko et al., 1997). Using a structured interview format, study partners are queried as to whether participants attempted each item in the inventory during the prior 4 weeks and their level of performance. Overall score range from 0 meaning fully independent to 78 meaning fully dependent on assistance for activities of daily living|Baseline to Week 4||||points||95% Confidence Interval|Mean
1351109|NCT01782742|Secondary|Change in NPI Scores in ALL Subjects From Baseline to Week 4|The NPI is a well validated, reliable, multi-item instrument to assess psychopathology in AD based on interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric disturbances. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously) as well as severity (1=mild, 2=moderate, 3=severe). The overall score and the score for each subscale are the product of severity and frequency. Overall score range from 0 meaning no disturbance to 144 meaning severe disturbance|Baseline to Week 4||||points||95% Confidence Interval|Mean
1351110|NCT01782742|Secondary|Change in the Global Clinical Dementia Rating Score in ALL Subjects From Baseline to Week 4|The CDR is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe (CDR score of 0, 0.5, 1, 2, or 3, respectively). Higher score means more severe dementia rating. The score is based on interviews with the participant and study partner, using a structured interview that assesses six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.|Baseline to Week 4||||units on a scale||95% Confidence Interval|Mean
1351111|NCT01782742|Secondary|Change in ADAS-Cog Score in ALL Subjects From Baseline to Week 4|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 85 (worse). A positive change indicates cognitive worsening.|Baseline to Week 4||||points||95% Confidence Interval|Mean
1351112|NCT01782742|Secondary|Change in MMSE Score in ALL Subjects From Baseline to Week 4|The MMSE evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons. A lower score indicates more cognitive impairment. The lowest score that any particular person can get is 0 and the highest score is 30.|Baseline to Week 4||||points||95% Confidence Interval|Mean
1351113|NCT01782742|Primary|Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain|The primary study endpoint for all subjects is the change from baseline to Week 4 in amyloid burden as measured by standard uptake units regional (SUVr) on amyloid brain imaging obtained through 18F-AV-45 PET|Baseline to Week 4||||SUVr||95% Confidence Interval|Mean
1351114|NCT01782690|Secondary|Score in Participant Questionnaire: Quality of Life|Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
1351115|NCT01782690|Secondary|Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation|Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
1351116|NCT01782690|Secondary|Score in Participant Questionnaire: What to Do in Case of Side Effect|Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
1351117|NCT01782690|Secondary|Score in Patient Questionnaire: Possible Side Effects|Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
1351118|NCT01782690|Secondary|Time to Disease Progression|Disease progression was defined in accordance with daily routine practice.|Up to 12 months|FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||months||95% Confidence Interval|Median
1351119|NCT01782690|Secondary|Percentage of Participants With Best Overall Response|Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.|Up to 12 months|FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||percentage of participants|||Number
1351120|NCT01782690|Secondary|Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)|Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.|Up to 12 months|FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||months||95% Confidence Interval|Median
1351121|NCT01782690|Secondary|Time of Onset of Rash After Start Erlotinib Treatment|Reported is the number of days from first erlotinib treatment to first rash onset.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication.|||days||Standard Deviation|Mean
1351122|NCT01782690|Secondary|Number of Dose Modifications and Dose Withdrawals of Gemcitabine|Reported is the number of dose modifications/withdrawals for gemcitabine.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication|||dose modifications/withdrawals|||Number
1351123|NCT01782690|Secondary|Number of Dose Modifications and Dose Withdrawals of Erlotinib|Reported is the total number of dose modifications/withdrawals for erlotinib.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication|||dose modifications/withdrawals|||Number
1351124|NCT01782690|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication.|||participants|||Number
1351125|NCT01782690|Secondary|Number of Participants With Rash by Severity|Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication.|||participants|||Number
1351126|NCT01782690|Primary|Overall Survival Stratified by Rash|Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no.|Up to 12 months|Full Analysis Set (FAS) included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||months||95% Confidence Interval|Median
1351127|NCT01782664|Secondary|Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12|Serum Neopterin is a marker of psoriatic disease activity. Blood samples were collected for estimation of serum neoprotein concentration. Baseline was Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|Baseline (pre-dose) and Weeks 2, 4, 8 and 12|ITT Population|||Nanomol per Liter (nmol/L)||Standard Deviation|Mean
1351128|NCT01782664|Secondary|Steady State Volume of Distribution (Vss) of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK Population|||L||Geometric Coefficient of Variation|Geometric Mean
1351129|NCT01782664|Secondary|Clearance of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK Population.|||Litre (L)/hr||Geometric Coefficient of Variation|Geometric Mean
1351130|NCT01782664|Secondary|Population Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK population. The PK Population comprised of all participants who were randomized and received at least one dose of study medication.|||Nanogram/milliLitre*hour (ng/mL*hr)||Geometric Coefficient of Variation|Geometric Mean
1351131|NCT01782664|Secondary|Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI was used to assess a participant’s health-related quality of life. Participants completed the questionnaire to evaluate how their psoriasis affected their life over the week before the assessment took place. Each of the 10 questions was scored out of 0–3 as; 0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much. The total score for the DLQI was calculated by adding up all the individual scores for each question resulting in a minimum of 0 and a maximum of 30. Higher score indicated worsening of participant’s quality of life. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|Baseline and Week 12|ITT Population. Only those participants who had a Week 12 evaluation were analyzed.|||Scores on a Scale||Standard Deviation|Mean
1351132|NCT01782664|Secondary|Itch VAS Scores at Week 2, 4, 8 and 12|The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. Itch VAS scores at Week 2, 4, 8 and 12 are reported.|Week 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
1351133|NCT01782664|Secondary|Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12|The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 millimeter(mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|From Baseline (Day 1) until Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
1351134|NCT01782664|Secondary|Time to PGA Score of 'Clear' (0) or 'Almost Clear' (1)|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale)4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|From Baseline (Day 1) until Week 12|ITT Population. Only participants achieving a PGA score of 'Clear' or 'Almost Clear' were analyzed.|||Days||Full Range|Median
1351135|NCT01782664|Secondary|Time to PASI 75|PASI 75 was >= 75% improvement from Baseline in PASI score. Psoriatic lesions were assessed by the investigator using a PASI score. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.|From Baseline (Day 1) until Week 12|ITT Population. Only participants achieving PASI 75 were analyzed.|||Days||Full Range|Median
1351136|NCT01782664|Secondary|Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|Weeks 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of Participants|||Number
1351153|NCT01782495|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1351137|NCT01782664|Secondary|Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of ‘Clear’ (0) or ‘Almost Clear’ (1) at Weeks 2, 4, 8 and 12|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|Weeks 2, 4, 8 and 12|ITT Population|||Percentage of Participants|||Number
1351138|NCT01782664|Secondary|Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.|From Baseline (Day 1) until Week 12|ITT Population.|||Percentage of Participants|||Number
1351139|NCT01782664|Secondary|PASI Score at Week 2, 4, 8 and 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1.|Week 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
1351140|NCT01782664|Secondary|Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|From Baseline (Day 1) until Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
1351141|NCT01782664|Secondary|Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings|ECG measurements were obtained using single 12-lead ECGs with the participant in a supine position after resting in this position for at least 10 minutes. The Baseline values were those values obtained Pre-dose on Day 1. The change from Baseline was the difference between post-Baseline and Baseline. The QT intervals (milliseconds [msec]) corrected for heart rate using Bazett's formula (QTcB) and Fridericia's formula (QTcF) are reported.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population.|||Participants|||Count of Participants
1351142|NCT01782664|Secondary|Change From Baseline in Body Temperature|Vital sign monitoring included body temperature measurements. Body temperature measurements were taken in the supine position after 5 minutes of rest. Baseline is defined as the last result on or before the day of first dose. Change from Baseline was determined by subtracting the indicated time point value minus the Baseline value.|From Baseline (Day 1) until Week 16|ITT Population. Only those participants available at the specified time points were analyzed.|||Celsius||Standard Deviation|Mean
1351143|NCT01782664|Secondary|Number of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study|"Vital sign monitoring included heart rate (HR) measurements. HR measurements were taken in supine position after 5 minutes of rest. The number of participants with HR outside the clinical concern range at any time post-BL are presented. HR low was any HR less than 40 beats per minute (bpm) and high was any HR greater than 110 bpm. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment."|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1351144|NCT01782664|Secondary|Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the Study|"Vital sign monitoring included systolic and diastolic BP measurements. BP measurements were taken in the supine position after 5 minutes of rest. The number of participants with the SBP or DBP outside the clinical concern range at any time post-BL are presented. SBP low was measured as less than 85 millimeters of mercury (mmHg)and high was measured as greater than 160 mmHg. DBP low was measured as less than 45 mmHg and high was measured as greater than 100 mmHg. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment."|From Baseline (Day 1) until the follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1351145|NCT01782664|Secondary|Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study|Safety and tolerability were assessed by measuring the clinical chemistry parameters such as creatinine and cystatin C. BL values were obtained at Day 1. The number of participants with the indicated hematology parameter data outside of the reference range (> high or < low) at any time post-BL, including unscheduled or scheduled assessments, are presented.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1351146|NCT01782664|Secondary|Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study|Hematology parameters included: basophils, eosinophils, erythrocyte mean corpuscular hemoglobin (EMCHb) EMCHb concentration (EMCHbC), erythrocyte mean corpuscular volume (EMCV), erythrocyte sedimentation rate (ESR), erythrocytes, hematocrit (fraction 1), hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, segmented neutrophils, platelets, reticulocytes. BL values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-BL are presented. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.|From BL (Day 1) until the Follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1351147|NCT01782664|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population|||Participants|||Number
1351148|NCT01782664|Primary|Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)|PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved >= 75% improvement from Baseline was reported with LOCF analysis.|Baseline and Week 12|Per-Protocol Population: Participants in the ITT analysis set who had no major protocol deviations.|||Percentage of participants|||Number
1351149|NCT01782664|Primary|Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)|PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved >= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.|Baseline and Week 12|Intent-to-Treat (ITT) Population: participants who received at least one dose of study medication.|||Percentage of participants|||Number
1351150|NCT01782495|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
1351151|NCT01782495|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment.|Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1351152|NCT01782495|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 24 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.|24 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
1351270|NCT01781026|Primary|Activity of Vemurafenib in Untreated Brain Metastases|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|Subjects withdrew prior primary outcome measurement therefore no data was obtained to report||||||
1351154|NCT01782482|Secondary|Positive Purchase Intent|"As reported on a questionnaire in response to, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing Definitely would purchase or Probably would purchase."|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||Percentage of participants|||Number
1351155|NCT01782482|Primary|Subjective Rating of Overall Satisfaction|Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||Units on a scale||Standard Error|Mean
1351156|NCT01782469|Secondary|Mean Change in Health Assessment Questionnaire (HAQ) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.|Baseline (Visit 1) to 13 weeks|Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.|||units on a scale||Standard Deviation|Mean
1351157|NCT01782469|Secondary|Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)|The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).|Baseline (Visit 1) to 13 weeks|All enrolled participants|||percentage of participants||95% Confidence Interval|Number
1351158|NCT01782469|Secondary|Mean Number of Joints With Detected Erosions|A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.|Baseline (Visit 1) to 13 weeks|Participants with available data|||joints||Standard Deviation|Mean
1351159|NCT01782469|Secondary|Mean Percent Reduction in Ultrasonography Assessment Score|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data|||Percent reduction||Standard Deviation|Mean
1351160|NCT01782469|Primary|Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data|||units on a scale||Standard Deviation|Mean
1351161|NCT01782326|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|52 weeks of treatment + 30 days|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included|||Number of participants|||Number
1351162|NCT01782326|Secondary|Change From Baseline in Forced Vital Capacity|Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction|4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included|||Liters||Standard Error|Least Squares Mean
1351163|NCT01782326|Secondary|Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.|Urine cortisol/creatinine ratio|Baseline, 52 Weeks|Urine cortisol set is the subset of patients who were measured with 24-hour Urine cortisol, a subset of safety set. The safety set included all patients who received at least one dose of study drug. At the post-baseline timepoint only patients with a value at both baseline and the post-baseline timepoint are included.|||ng/mL||Full Range|Median
1351164|NCT01782326|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication|A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in LLM are included.|||Number of puffs per day||Standard Error|Least Squares Mean
1351165|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
1351166|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
1351167|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
1351168|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
1351169|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
1351170|NCT01782326|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time”|Baseline, 52 weeks|Serial spirometry set - Serial spirometry set includes the patients who performed additional serial spirometry, a subset of FAS. Only patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
1351171|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
1351212|NCT01781962|Secondary|Number of Study Eyes in Each Step Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.|||eye|Participants||Number
1351172|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
1351173|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
1351174|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
1351175|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
1351176|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, day 1 (30 min and one hour post dose)|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and did not have any major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
1351177|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
1351178|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
1351179|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
1351195|NCT01782313|Secondary|Overall Response Rate Defined as Complete Response and Partial Response.|"The response to study treatment will be assessed after every 8 weeks (2 cycles) of therapy using CT or MRI scan images.Overall response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI:~Complete response (CR) = disappearance of all target lesions. Partial Response (PR), = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|Every 2 cycles (8 weeks) up to 2 years|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Participants|||Count of Participants
1351180|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
1351181|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||Standard Deviation|Mean
1351182|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.|All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
1351183|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included .|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
1351184|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
1351185|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks.|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in the Cox regression model are included.|||Days||95% Confidence Interval|Median
1351186|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations.|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
1351187|NCT01782326|Secondary|Time to First COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
1351333|NCT01780506|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in hip BMD (g/cm^2)||Standard Deviation|Mean
1351188|NCT01782326|Primary|Rate of COPD Exacerbations|COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used.|52 weeks|The per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Only PPS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbations/year||95% Confidence Interval|Least Squares Mean
1351189|NCT01782313|Post-Hoc|Number of Patients With 0-3 PDGFR Alpha and PDGFR Beta Protein Expression and Time in Days on Treatment|"Tissue from biopsy will be collected during screening and proteins (PDGFR alpha and PDGFR beta) will be evaluated to see if there is a correlation with patient response to treatment.~PDGFR= Platelet derived growth factor receptor~To determine if there was a correlation between response to Tivozanib and PDGFR expression, immunohistochemical (IHC) analysis on archival tumor tissue was performed. We performed standard IHC and applied combined intensity score (from 0 to 3) for antigen expression and proportional score of 0-3 for the cells that were positive. For antigen expression, 0 was no staining, +1 being 1-25% staining, +2 being 26-50% staining and +3 being 50% or greater staining. Number of patients with PDGFR alpha and PDGFR beta expression was correlated with time patients were on treatment in days."|Tissue collected during screening process, prior to first treatment and response measured until 350 days.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment. Not all patients treated on study provided tissue or had sufficient tissue to be analyzed for PDGFR expression. No patients showed PDGFR alpha +1 or +3 expression.|||participants|||Number
1351190|NCT01782313|Post-Hoc|Number of Patients With 0-3 VEGFR3 Protein Expression and Time in Days on Treatment|"Tissue from biopsy will be collected during screening and proteins (VEGFR3) will be evaluated to see if there is a correlation with patient response to treatment.~VERGFR = vascular endothelial growth factor receptor~To determine if there was a correlation between response to Tivozanib and VEGFR expression, immunohistochemical (IHC) analysis on archival tumor tissue was performed. We performed standard IHC and applied combined intensity score (from 0 to 3) for antigen expression and proportional score of 0-3 for the cells that were positive. For antigen expression, 0 was no staining, +1 being 1-25% staining, +2 being 26-50% staining and +3 being 50% or greater staining. Number of patients with VEGFR1 expression was correlated with time patients were on treatment in days."|Tissue collected during screening process, prior to first treatment and response measured until 350 days.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment. Not all patients treated on study provided tissue or had sufficient tissue to be analyzed for VEGFR expression.|||participants|||Number
1351191|NCT01782313|Secondary|Treatment Toxicity as Measured by Adverse Events Experienced While on Treatment During Systematic Assessment.|"Toxicity will be assessed after 4 weeks (1 cycle) and every 4 weeks during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|After every 4 weeks (1 cycle) until treatment discontinuation and up to a maximum of 2 years and 10 months.|All patients were considered to be evaluable for adverse events. Frequency of treatment related adverse events equal to or more than 10% graded to be either 1 (mild), 2 (moderate),3 (severe), 4 (life-threatening).|||participants|||Number
1351192|NCT01782313|Secondary|Number of Patients With 0-3 VEGFR1 and VEGFR2 Protein Expression and Time in Days on Treatment|"Tissue from biopsy will be collected during screening and proteins (VEGFR1 and VEGFR2) will be evaluated to see if there is a correlation with patient response to treatment.~VERGFR = vascular endothelial growth factor receptor~To determine if there was a correlation between response to Tivozanib and VEGFR expression, immunohistochemical (IHC) analysis on archival tumor tissue was performed. We performed standard IHC and applied combined intensity score (from 0 to 3) for antigen expression and proportional score of 0-3 for the cells that were positive. For antigen expression, 0 was no staining, +1 being 1-25% staining, +2 being 26-50% staining and +3 being 50% or greater staining. Number of patients with VEGFR1 expression was correlated with time patients were on treatment in days."|Tissue collected during screening process, prior to first treatment and response measured until 350 days.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment. Not all patients treated on study provided tissue or had sufficient tissue to be analyzed for VEGFR expression.|||participants|||Number
1351193|NCT01782313|Secondary|Overall Survival up to 2 Years Beyond Progression|Patients will be followed-up with from first dose of study drug up to 2 years following the date of disease progression.|Time from the first dose of study treatment up to 2 years beyond disease progression|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Months||95% Confidence Interval|Median
1351194|NCT01782313|Secondary|Clinical Benefit Rate as Defined by Complete Response, Partial Response and Stable Disease.|"The clinical benefit of study treatment will be assessed after 8 weeks (2 cycles) of therapy using scanning images (CT or MRI). Clinical benefit rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI:~Complete Response (CR) = disappearance of all target lesions. Partial Response (PR), = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD) = At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|Every 2 cycles (8 weeks) up to 2 years|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Participants|||Count of Participants
1351213|NCT01781962|Secondary|Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.|||eye|Participants||Number
1351196|NCT01782313|Primary|Percentage of Patients With Progression-free Survival at 16 Weeks.|"Progression-free survival from study disease will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Committee, version 1.1 assessed using imaging scans (CT or MRI) and clinical assessment following 16 weeks of treatment.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|At 16 weeks of treatment.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Percentage of patients||95% Confidence Interval|Number
1351197|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness)|"The Clinical Global Impression (CGI) scales (Guy and Bonato, 1970) were initially developed for a risk-benefit estimation within the treatment of mentally ill patients. The 4 global scales (severity of illness, change in severity from Baseline, therapeutic efficacy, and tolerability of treatment) are used as different measures of treatment outcome in different kinds of pharmacological studies.~The CGI Item 1 (severity of illness) collected 1 answer out of 8 categories (0-‘Not assessed’, 1-‘Normal, not at all ill’, 2-‘Borderline ill’, 3-‘Mildly ill’, 4-‘Moderately ill’, 5-‘Markedly ill’, 6-‘Severely ill’, and 7-‘Among the most extremely ill patients’) at each assessment. The category 0-‘Not assessed’ was considered as missing and therefore used neither for calculation nor for display purposes."|Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||participants|||Number
1351198|NCT01782222|Secondary|"Change From Baseline to the End of the Maintenance Period in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) in on State"|"Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit.~The UPDRS Part III (motor subscale) had to be measured in the “on” state and consisted of 27 items and sub items scored between 0 and 4. The sum score ranged between 0 and 108 and was calculated as sum of the 27 individual scores. If 1 or more items were missing and could not be substituted with a previous post-Baseline value, the sum score was also missing.~A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351199|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory (BDI) is a self-report instrument to measure depression symptoms and severity (Beck et al, 1961). The BDI-II is a revised version of the scale in order to be more consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression (Beck et al, 1996). There are 21 items in the BDI-II, classified as cognitive-affective (Items 1-13) and somatic-performance (Items 14-21) subscales. The degree of severity is indicated on a 4-point scale; items are rated from 0 (not at all) to 3 (extreme form of each symptom). Scores of 0-13 indicate minimal depression, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351200|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)|The Snaith Hamilton Pleasure Scale (SHAPS) (Snaith et al, 1995) is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores range from 0 to 14. A higher score represents more anhedonic symptoms.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351201|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Mood / Cognition Domain of the Nonmotor Symptom Assessment Scale (NMSS)|"Nonmotor performance was assessed via the Nonmotor Symptom Assessment Scale (NMSS), an accepted scale that has been validated in an international study (Naidu et al, 2006; Chaudhuri et al, 2007), at the Baseline Visit as well as at the end of the Maintenance Period. The severity and frequency of the subject’s nonmotor symptoms were assessed by the investigator (or designee) in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; and miscellaneous.~Items are scored for severity (from 0 (none) to 3 (severe)) and frequency (from 1 (rarely) to 4 (very frequent )). The score was calculated as severity x frequency. The theoretical minimum is 0 (best possible outcome) and maximum total score is 360 points (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351334|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
1351202|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 collects 8 items with 5 categories each (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always or cannot do at all). The total score was calculated by summing the scores of all applicable questions and convert the resulting sum to a summary index score between 0 and 100 by multiplying with 100/32. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351203|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Caregiver (Where Available)|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the caregiver. The questions were asked in a structured interview format. The caregiver was interviewed by appropriate medical staff and asked questions about the subject in the third person.The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351204|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Total Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living) + III (Motor Symptoms)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject’s activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351205|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the subject. The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
1351206|NCT01781975|Secondary|Number and Severity of Adverse Events|Number and severity of adverse events that were reported throughout the study.|Adverse Events will be assessed at Visit 0 (week 0), Visit 1 (Week 2), Visit 2 (Week 4), and every month thereafter.||2019-05-31|05/2019||||
1351207|NCT01781975|Secondary|Number of Severe Hypoglycemic Events|Major hypoglycemic events occurring from randomization at weeks 0, 52 and 104.|Visit 0 (Week 0), Visit 9 (Week 52), and Visit 13 (Week 52)|||||||
1351208|NCT01781975|Secondary|Change in Insulin Dose (Units/kg) Over Time|Assess insulin use in units per kilogram body weight per day at weeks 52 and 104.|Visit 9 (Week 52) and Visit 13 (Week 104)|||||||
1351209|NCT01781975|Secondary|Change in HbA1c Levels Over Time|Changea in HbA1c levels from Week 52 to Week 104|Visit 9 (Week 52) and Visit 13 (Week 104)||2019-05-31|05/2019||||
1351210|NCT01781975|Secondary|Area Under the Stimulated C-peptide Curve (AUC) Mean Over 4 Hours at 24 Months|Area under the MMTT-stimulated peak, 2 hour C-peptide, and 4 hour C-peptide AUC mean at week 104.|Visit 13 (Week 104)||2019-05-31|05/2019||||
1351211|NCT01781975|Primary|Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit|The primary outcome of each participant is the area under the stimulated c-peptide curve (AUC) mean based on data collected at time 0 to 2 hours of a 4-hour mixed meal tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30, 60, 90, and 120 minutes. The term “AUC mean” comes from the mean value theorem in calculus. It is the value on the scale of the y-axis that is equal to the AUC divided by the range on the x-axis (in this case 120 minutes).|Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose||||nmol/L||Standard Deviation|Mean
1351335|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
1352114|NCT01769443|Secondary|Incidence of Acute Renal Failure Requiring Hemodialysis||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351214|NCT01781962|Primary|Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)|The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.|Day 1|Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure.|||µm|Participants|Standard Deviation|Mean
1351215|NCT01781832|Primary|Shear Wave Velocity (VITQ)|Shear Wave Velocity, VITQ, or Virtual Touch Tissue Imaging quantification is a color 2D method for measuring a tissues's stiffness. A color image (elastogram) of stiffness is acquired using this method. Then, one or more regions of interest can be placed in the area of interest on the elastogram. VITQ regions of interest are smaller than those used by VTQ.|Visit 0|The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the bladder. The ultrasound scans may be an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure.|||meters per second||Standard Deviation|Mean
1351216|NCT01781832|Primary|Shear Wave Velocity, VTQ|"Shear wave velocity VTQ, or Virtual Touch Quantification is a point method for measuring a tissue's stiffness. A stiffness value is obtained from only the area in which a region of interest is placed."|Visit 0|"The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the urinary bladder.~The ultrasound scans were investigated as an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure."|||meters per second||Standard Deviation|Mean
1351217|NCT01781806|Other Pre-specified|Number of HIV Seroconversions by Cohort.||Baseline to 48 weeks||||Participants|||Count of Participants
1351218|NCT01781806|Other Pre-specified|Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline|Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.|Baseline to 48 weeks||||Participants|||Count of Participants
1351219|NCT01781806|Secondary|Cohort H PrEP Engagement by Study Visit|Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).|Baseline to 48 weeks||||Participants|||Count of Participants
1351220|NCT01781806|Primary|Number of Participants With a Grade 2 or Higher Adverse Event by Cohort|Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.|Baseline to 48 weeks||||Participants|||Count of Participants
1351221|NCT01781637|Secondary|Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo||12 weeks after last dose of omalizumab/placebo||||Participants|||Count of Participants
1351222|NCT01781637|Primary|Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo||6 weeks after last dose of omalizumab/placebo||||Participants|||Count of Participants
1351223|NCT01781481|Primary|Number of Inpatient Hospital Admissions|Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Number of hospital admissions||Full Range|Median
1351224|NCT01781481|Primary|Number of Visits to the Hospital Emergency Department|Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Emergency Department Visits||Full Range|Median
1351225|NCT01781481|Primary|Number of Extra Appointments With the IBD Team|Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Number of appointments||Full Range|Median
1351226|NCT01781481|Primary|Number of Calls to IBD Nurse|Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Number of calls||Full Range|Median
1351227|NCT01781481|Primary|Total Number of Hospital Services Involved in Child's Care.|Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||R Square change statistic||Full Range|Median
1351228|NCT01781481|Primary|Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.|Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis||||Correlation Coefficients|||Number
1351235|NCT01781481|Primary|Family Inventory of Resources for Management|Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.|||units on a scale||Inter-Quartile Range|Median
1351229|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.|||participants|||Number
1351230|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.|||participants|||Number
1351231|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.|||participants|||Number
1351232|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.|||participants|||Number
1351233|NCT01781481|Primary|Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.|Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).|Day 1 (Time of Study Participation)||||Pearson Correlation Coefficient|||Number
1351234|NCT01781481|Primary|Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.|Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis||||Correlation Coefficients|||Number
1351246|NCT01781481|Primary|IBD Disease Severity|IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).||||percentage of participants|||Number
1351247|NCT01781481|Primary|Pediatric INTERMED Items|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.|Day 1 (At time of Pediatric Intermed Interview)||||Percentage of participants|||Number
1351236|NCT01781481|Primary|Family Inventory of Life Events and Changes|Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.|||units on a scale||Inter-Quartile Range|Median
1351237|NCT01781481|Primary|Pediatric Inventory for Parents- Difficulty Score|"Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater perceived difficulty."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.|||units on a scale||Inter-Quartile Range|Median
1351238|NCT01781481|Primary|Multidimensional Anxiety Scale for Children|"Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) never true about me to (3) often true about me. Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.|||units on a scale- T scores||Inter-Quartile Range|Median
1351239|NCT01781481|Primary|Children's Depression Inventory|27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.|Administered at study entry|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.|||Units on a Scale - T Scores||Inter-Quartile Range|Median
1351240|NCT01781481|Primary|Child Behaviour Checklist|Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.|||Units on a Scale - T Scores||Inter-Quartile Range|Median
1351241|NCT01781481|Primary|Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.|35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.|||units on a scale||Inter-Quartile Range|Median
1351242|NCT01781481|Primary|Functional Disability Inventory|"Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) no trouble to (4) impossible. The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991)."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).||||units on a scale||Full Range|Median
1351243|NCT01781481|Primary|IBD Treatment With Immunomodulators or Anti-TNFa Medications|"Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as yes (Score of 1) or no (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as yes (Score of 1) or no (Score of 2)."|Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).||||Percentage of participants treated|||Number
1351244|NCT01781481|Primary|Disease Course and Treatment|Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).|Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)||||number of times it occurred||Full Range|Median
1351245|NCT01781481|Primary|Time Since IBD Diagnosis|"Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in months since date of diagnosis, with a range from 1 - 131 months."|Data collected through chart review at time of Pediatric INTERMED interview.||||Percentage of Participants|||Number
1351249|NCT01781481|Primary|Pediatric INTERMED- Complexity Index|"34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action).~Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains:~Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity).~Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity).~Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity).~Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity).~Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity)."|Time of Study Participation (Completion of Pediatric INTERMED tool)||||scores on a scale||Inter-Quartile Range|Median
1351250|NCT01781403|Other Pre-specified|Disease-free Survival||3-year or 5-year after surgery|||||||
1351251|NCT01781403|Other Pre-specified|Efficacy|"Efficacy: Pathologic major responses = total regression + near total regression.~We will carefully inspect the circumferential resection margin, defining a positive margin as any residual tumor within ≤ 1 mm of the circumferential margin.~Pathologic responses and stages will be classified according to Dworak’s classification1 and the AJCC (American Joint Committee on Cancer) staging system, respectively. In each case, the entire tumor including mesorectal fat will be serially sliced into 4-mm-thick sections and embedded in paraffin.~A pathologic complete response is defined as grade 4 tumor regression; with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells~A near total response is defined as grade 3 tumor regression; with very few tumor cells in fibrotic tissue with or without mucous substance."|after surgery (6-8 weeks after study treatment)|||||||
1351252|NCT01781403|Other Pre-specified|Toxicity|"Toxicity will be monitored and recorded every week during study treatment (5 or 6 weeks) as following according to the NCI-CTCAE version 4.0~An interval history and physical examination with particular attention to drug-induced side effects along with documentation of the patient’s weight and performance status will be performed on each visit.~CBC with differential count, blood chemistry including calcium, phosphorus, glucose, BUN, creatinine, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, and electrolyte will be performed before next planned treatment.~All relevant information regarding drug dosage, laboratory examinations, and treatment-related toxicities must be recorded before each treatment is given.~Summaries of the frequency and severity of adverse effects are based on the worst episodes recorded."|5-6 weeks during study treatment||||events|||Number
1351253|NCT01781403|Secondary|Pathological Complete Response|"Pathologic responses and stages were classified according to Dworak’s classification and the 7th edition of the American Joint Committee on Cancer staging system, respectively.~The pathologic complete response (pCR) was defined as the total regression of the primary tumor regardless of regional lymph nodal status (ypT0), with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells."|at the time of surgery (6-8 weeks after study treatment)||||participants|||Number
1351254|NCT01781403|Primary|Recommended Dose (RD)|RD will be defined as one level below the MTD.|5-6 weeks after CRT||||mg/m^2|||Number
1351255|NCT01781403|Primary|Maximum Tolerated Dose (MTD)|The MTD is defined as the maximum dose level in the doses of temozolomide tested with capecitabine and radiation in which the incidence proportion of DLT exceeds 30%.|5-6 weeks during study treatment||||mg/m^2|||Number
1351256|NCT01781299|Secondary|Aesthetic Evaluation|Initial aesthetic evaluation will occur at approximately 6 weeks after permanent implant placement. Re-evaluation will occur at 1 and 3 years following permanent implant placement. This will involve physical examination, 2D photographs, and patient Breast-Q self-examination. Breast-Q examination is on a scale of 25-100 with 25 questions on a scale of 1-4 where 1 is very dissatisfied and 4 is very satisfied.|3 years following permanent implant placement.|discrepancy is caused by funding ending and no data was collected from SurgiMend arm.|||units on a scale||Full Range|Mean
1351257|NCT01781299|Primary|Complication Rates|To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years.|3 years||||Participants|||Count of Participants
1351258|NCT01781286|Secondary|Energy Intake|"Post-snack energy intake will be assessed through ad libitum dinner and snacking assessments. The ad libitum dinner will contain approximately 2,000 kcal and will consist of a chicken, rice, and stir-fry meal, chips, chocolate mints, ice tea, and water. The dinner meal will be consumed in the testing facility. The participants will be instructed to eat as much as or as little as they choose over a 30 min period. All contents will be weighed before the dinner and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed.~The ad libitum evening snacks will contain 3,000 kcal and will include common snack foods. After the testing day is complete, the participants will take the snack packout home and consume any of the foods he/she chooses until going to bed. All contents will be weighed before the packout and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed."|+300 min, 24 h||||kilojoules||Standard Error|Mean
1351259|NCT01781286|Secondary|Mood-state Questionnaires|Indices of mood state will be assessed immediately before and 60 min post-snack using the on-line, Profile of Mood States, 2nd Edition (POMS2). This program consisted of a core battery of tests with the following sub-categories 1) Tension; 2) Depression; 3) Anger; 4) Vigor; 5) Fatigue; 6) Confusion; and 7) Friendliness. Outcomes are scored as a T-score which could be a minimum of zero with no upper limit. A lower score represents a more positive mood state and a higher score represents a more negative mood state.|-30 min, +60 min||||T-Score||Standard Error|Mean
1351271|NCT01780987|Secondary|Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods|All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.|||participants|||Number
1352115|NCT01769443|Secondary|Incidence of Cerebral Vascular Accident||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351260|NCT01781286|Secondary|Attention & Memory Questionnaires|Cognitive function will be assessed immediately before (-30 min) and 60 min post-snack using the lap-top based Cantab® computerized assessment system. This program consisted of a core battery of tests grouped into main categories including 1) Working Memory; 2) Reasoning; 3) Executive Function; 4) Reaction Time; 5) Sustained Attention; 6) Cognitive Flexibility; and 7) Processing Speed. This program has been used in our previous breakfast studies with success. A greater raw score for working memory, reasoning, executive function, sustained attention, and cognitive flexibility is considered to be greater performance. A lower score for reaction time and processing speed is considered to be greater performance. The raw scores are determined by Cantab® computerized assessment system. Therefore, maximum and minimum values for each test are unknown.|90 min||||Units on a Scale||Standard Error|Mean
1351261|NCT01781286|Secondary|Snack Palatability and Perception Questionnaires|"Computerized questionnaires, assessing snack palatability and perceptions of the snack will be completed during screening and after the first and last bite of each snack during the acclimation and testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as how strong is your feeling of with anchors of not all (scores 0 out of 100) to extremely (scores 100 out of 100). The questions assess snack appearance, smell, flavor, texture (feel), liking.~The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments."|5 min||||millimeters||Standard Error|Mean
1351262|NCT01781286|Secondary|Appetite Questionnaires|"Computerized questionnaires, assessing perceived sensations of appetite will be completed throughout the testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as how strong is your feeling of with anchors of not all (scored as 0 out of 100) to extremely (scored as 100 out of 100). The following questions will be incorporated as 1 composite score ((Questions 1 + 3 + 4 - 2)/4) multiplied by the 300 minutes (a max of 30,000 mm*min and a minimum of -30,000 mm*min):~How strong is your feeling of hunger?~How strong is your feeling of being full?~How strong is your desire to eat?~How much food could you consume right now?~The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments."|0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min||||mm*min||Standard Error|Mean
1351263|NCT01781286|Primary|Time to Dinner Request|"The participants will be asked whether they would like to request a dinner buffet throughout the 5 h post-snack period. When the response is Yes, I want to eat right now, the time from snack consumption will be recorded."|1 Day||||minutes||Standard Error|Mean
1351264|NCT01781208|Primary|ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score|"Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures.~Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis."|10 minutes|"49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams.~48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams."|||m/s||Standard Deviation|Mean
1351265|NCT01781169|Primary|Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)||Endpoint and baseline of the 8 weeks' trial||||nmol/L||Standard Deviation|Mean
1351266|NCT01781078|Secondary|Proportion of Participants Without ImageReady System-related Complications|Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.|3 months post implant||||Percentage of participants||95% Confidence Interval|Number
1351267|NCT01781078|Primary|Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit|The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.|MRI + 1 Month Visit|Right Atrium: a total of 78 Control Group subjects and 135 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria. Right Ventricle: a total of 91 Control Group subjects and 152 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria.|||% of participants with success|||Number
1351268|NCT01781078|Primary|Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit|"The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.~Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups."|MRI + 1 Month Visit|For the per-protocol analysis, a total of 96 Control Group subjects and 167 MRI Group subjects had paired threshold measurements and met the inclusion criteria.|||% of participants with success|||Number
1351269|NCT01781078|Primary|Proportion of Participants Without MR Scan-related Complications|The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.|MRI Visit + 1 Month|The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who underwent any portion of the MRI scan sequences and did not have a medically necessary scan performed prior to the MRI visit + 1 month follow-up.|||Percentage of participants||95% Confidence Interval|Number
1351296|NCT01780922|Primary|Interleukin-8 (IL-8) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351297|NCT01780922|Primary|Interleukin-6 (IL-6) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351298|NCT01780922|Primary|Interleukin-4 (IL-4) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351272|NCT01780987|Secondary|Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.|||participants|||Number
1351273|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)|Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated.|||participants|||Number
1351274|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)|Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated.|||participants|||Number
1351275|NCT01780987|Secondary|Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period|"VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. Intended Treatment Period was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late."|Baseline to Week 24|Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis.|||participants|||Number
1351276|NCT01780987|Primary|Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.|||participants|||Number
1351277|NCT01780974|Secondary|White Matter Hyperintensity Volume (Brain MRI)||Baseline and 12 months|At baseline, 4 participants either could not complete the MRI or the MRI could not be analyzed due to quality; at 12 months, 13 participants either discontinued, could not complete the MRI, or did not complete the baseline and therefore were not scanned.|||cubic centimeters||Standard Deviation|Mean
1351278|NCT01780974|Primary|Trails Making Test Part B (Executive Function)|"The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the trail. If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment."|Baseline, 6 months, and 12 months|Not all tests were completed by all randomized subjects due to missed visits and/or discontinuations.|||time to completion (seconds)||Standard Deviation|Mean
1351279|NCT01780935|Secondary|Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Screening to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351280|NCT01780935|Secondary|Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351281|NCT01780935|Secondary|Treatment Patterns Over Time in Both Treatment Arms|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351299|NCT01780922|Primary|Interleukin-2 (IL-2) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351300|NCT01780922|Primary|Interleukin-1beta (IL-1b) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351282|NCT01780935|Secondary|Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351283|NCT01780935|Secondary|Dry Retina in the Study Eye on OCT at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351284|NCT01780935|Secondary|Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351285|NCT01780935|Secondary|Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351286|NCT01780935|Secondary|Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 3 to Month 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351287|NCT01780935|Secondary|Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351288|NCT01780935|Secondary|Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351289|NCT01780935|Secondary|Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
1351290|NCT01780935|Secondary|Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12|Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients|||letters correctly read||Standard Deviation|Mean
1351291|NCT01780935|Primary|Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12|Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients|||Letters correctly read||Standard Deviation|Mean
1351292|NCT01780922|Primary|Urinary Anti-bacteria Adhesion Activity||0, 3, 6, 9, 12, 24 h||||mg PAC/mg creatinine||Standard Error|Mean
1351293|NCT01780922|Primary|Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351294|NCT01780922|Primary|Interferon-gamma (IFN-y) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351295|NCT01780922|Primary|Interleukin-10 (IL-10) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
1351314|NCT01780584|Secondary|Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms.|Specific symptoms of hyperthyroidism included cardiac dysrhythmia requiring medical or electrical treatment, hypertension (mean systolic or diastolic blood pressure more than 2 standard deviation above normal for age) and hyperthermia (>37.5 degree Celsius). One patient in low dose group had hypertension directly after surgery due to unrecognized coarctation of the aorta and this patient was withdrawal from the protocol.|Since the first dose of oral T3 until 7 days after surgery|Three patients were excluded from adverse effect analysis. Two patients, each in placebo and high dose group were on Extracorporeal Membrane Oxygenation. One patient in high dose group could not attained enteral feeds due to gastrointestinal bleeding and was withdrawal from the protocol.|||participants|||Number
1351315|NCT01780584|Primary|Free T3 (FT3) Levels|Free T3 levels were measured up to 36 hours after cross-clamp removal|during the first 36 hours after cross clamp removal|Two subjects (one in T3 low dose and one in T3 high dose) were withdrawn from the treatment protocol. The withdrawal in low dose group was because of severe hypertension caused by a previously unrecognized coarctation of the aorta, and the high dose group withdrawal was due to massive gastrointestinal bleeding.|||pg/ml||Standard Error|Mean
1351316|NCT01780545|Secondary|Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity|To evaluate the effect of therapy with docetaxel and OGX-427 on peripheral blood circulating tumor cells (CTCs) enumeration and expression of Hsp27 and other relevant proteins via immunoflourescence, and levels of telomerase by quantitative polymerase chain reaction (PCR), and explore their relation with clinical outcomes.|Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5|Data for this secondary objective was not collected or analyzed.||||||
1351317|NCT01780545|Secondary|Hsp27 Expression in Archival Tissue|To evaluate the association of urothelial carcinoma expression of Hsp27 measured by immunohistochemistry (IHC) in archival tissue with clinical outcomes.|Cycle 1|Data for this secondary outcome was not collected or analyzed.||||||
1351318|NCT01780545|Secondary|Overall Survival (OS) According to Baseline Serum Hsp27 Level.|A subgroup analysis to determine the median overall survival time based on baseline Hsp27 levels.|36 months|Subjects with a baseline Hsp27 level were included in this subgroup analysis|||months||95% Confidence Interval|Median
1351319|NCT01780545|Secondary|Overall Response Rate|To compare overall response rate (ORR) between the treatment arms.|Every 6 weeks|Data for this secondary outcome measure was not collected nor analyzed.||||||
1351320|NCT01780545|Secondary|Safety and Toxicity of Regimen|To compare the safety and toxicity of OGX-427 in combination with docetaxel to that of docetaxel alone. A summary of per-patient maxiumy grade adverse events of any type is included in the Outcome Measure. Full adverse event information will be submitted further in the record.|36 Months|190 participants who intiated protocol treatment were included in the safety population|||Participants|||Count of Participants
1351321|NCT01780545|Primary|Overall Survival|To determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone.|36 Months||||months||95% Confidence Interval|Median
1351322|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1351323|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1351324|NCT01780506|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1351325|NCT01780506|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change in ratio (µg/g)||Inter-Quartile Range|Median
1351326|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 96 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1351327|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
1351328|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
1351329|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Safety Analysis Set. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
1351330|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
1351331|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percentage change in spine BMD (g/cm^2)||Standard Deviation|Mean
1351336|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48 and 96|Full Analysis Set|||percentage of participants|||Number
1351337|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Full Analysis Set|||percentage of participants|||Number
1351338|NCT01780506|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1351339|NCT01780389|Secondary|Change in Total Score of Short Form-36 (SF-36), Measuring Perceived Quality of Life|"Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.~The eight sections are:~vitality,~physical functioning,~bodily pain,~general health perceptions,~physical role functioning,~emotional role functioning,~social role functioning,~mental health~Scale:~0= lowest quality of life 100= high quality of life Higher scores reflect higher quality of life. Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
1351340|NCT01780389|Secondary|Change in Total Score of State Trait Anxiety Inventory (STAI)|"Assessment of subjective symptoms of current anxiety and chronic anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” All items are rated on a 4-point scale (e.g., from “Almost Never” to “Almost Always”). Higher scores indicate greater anxiety.~Lowest total score is 40 (absent anxiety) Highest total score is 160 (maximum anxiety) Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
1351341|NCT01780389|Secondary|Change in the Montgomery Asberg Depression Rating Scale|"Staff-rated assessment of depressive symptoms. Scale is as follows:~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Between baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
1351342|NCT01780389|Secondary|Change in the Beck Depression Inventory (BDI-II)|"The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression. The higher the score the degree of depression."|Baseline to endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
1351343|NCT01780389|Secondary|Change in Total Score of Multidimensional Fatigue Inventory (MFI-20)|"Measures subjective fatigue.20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue.~Each scale contains four items rated on a scale of one to 5 with the scale score of one having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. The five scales were identified through factor analysis and are assumed to measure different aspects of fatigue. Lowest possible total score = 20 (absent fatigue) Highest possible total score = 100 (maximum fatigue) Total mean cumulative scores were reported"|Baseline to endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
1351344|NCT01780389|Secondary|Global Rating of Change||Endpoint (12 weeks or early termination)|Data not collected.||||||
1351345|NCT01780389|Secondary|Change in Knee Society Score (KSS).|"KSS measures subjective pain and objective function by joint physical exam. This secondary outcome was the change in Knee Society Score(KSS)from baseline through 12 weeks.~KSS scores measured on a scale of 0 to 100 mm:~0 = absence of pain or no pain noted 100= worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|between baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
1351346|NCT01780389|Primary|Change in Pain Visual Analogue Scale(VAS).|"The primary outcome is change in pain VAS from baseline to 12 weeks (baseline score minus 12 week or endpoint score; positive number reflects reduction in pain score). The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm:~0= absence of pain or no pain noted 100 = worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|baseline and endpoint 12 weeks||||units on a scale||Standard Deviation|Mean
1351347|NCT01780350|Secondary|Tolerability|Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.|Duration of device use, up to 1 hour||||participants|||Number
1351348|NCT01780350|Primary|Change in Systolic Blood Pressure From Baseline (Before ITD Use)|Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.|During device use, up to 1 hour||||mmHg||Standard Deviation|Mean
1351349|NCT01780337|Primary|Change in Electrophysiology Measure of Right Ventricular Refractory Period|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group.|||milliseconds||Standard Deviation|Mean
1351350|NCT01780337|Primary|Change in Electrophysiology Measure of HV Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group. Only 5 out of 6 were evaluable for the Saline group.|||milliseconds||Standard Deviation|Mean
1351351|NCT01780337|Primary|Change in Electrophysiology Measure of AH Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 3 out of 6 were evaluable for the Oxytocin group. Only 2 out of 6 were evaluable for the Saline group.|||milliseconds||Standard Deviation|Mean
1351352|NCT01780324|Primary|Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale|Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.|At time of procedure (up to 30 seconds after catheter insertion)||||units on a scale||95% Confidence Interval|Median
1351353|NCT01779869|Primary|Diagnostic Accuracy of Cardiac PET/MRI Examination|"The accuracy of the cardiac PET and cardiac MR examination components of the PET/MRI, and the accuracy of the combined PET/MR examination, for ischemic heart disease will be compared to the accuracy of cardiac SPECT in patients who have had ICA as truth or the reference standard. To assess the accuracy of an abbreviated PET/MR examination, an additional accuracy analysis was made using only the stress PET perfusion imaging and the MR LGE data sets. The accuracy of this combined data set was also determined with ICA as truth or the reference standard. Accuracy is calculated as % difference = (experimental – true) x 100%."|PET/MRI imaging was performed within 10 days after SPECT-MPI examination|Patients who completed the full PET-MR myocardial perfusion examination|||percentage||95% Confidence Interval|Number
1351354|NCT01779648|Secondary|Cycling Rate|Number of cuff inflation-deflation cycle during an hour. In group SF, the cycling rate is fixed as 90 cycles/hour, but in group AA, it is variable according to the individual venous refill time.|on 4th postoperative day after total knee replacement arthroplasty||||cycles/hour|Participants|Standard Deviation|Mean
1351355|NCT01779648|Secondary|Augmented TVF|Enhanced total volume flow by application of pneumatic compression|on 4th postoperative day after total knee replacement arthroplasty||||mL/min|Participants|Standard Deviation|Mean
1351356|NCT01779648|Secondary|Augmented PVF|Enhanced peak volume flow by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty||||mL/min|Participants|Standard Deviation|Mean
1351357|NCT01779648|Secondary|Augmented MV|Enhanced mean velocity by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec|Participants|Standard Deviation|Mean
1351358|NCT01779648|Secondary|Augmented PV|Enhanced peak velocity by application of intermittent pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec|Participants|Standard Deviation|Mean
1351359|NCT01779648|Secondary|Expelled Peak Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled peak volume (EPV) = single cycle augmented PVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty||||mL/hour|Participants|Standard Deviation|Mean
1351360|NCT01779648|Secondary|Expelled Total Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled total volume (ETV) = single cycle augmented TVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty||||mL/hour|Participants|Standard Deviation|Mean
1351361|NCT01779648|Secondary|Total Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Total volume flow (TVF) was automatically calculated by the software.|On 4th postoperative days after total knee replacement arthroplasty||||mL/min||Standard Deviation|Mean
1351362|NCT01779648|Secondary|Peak Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Peak volume flow (PVF) was automatically calculated with 1-second interval around the PV.|On 4th postoperative days after total knee replacement arthroplasty||||mL/min||Standard Deviation|Mean
1351363|NCT01779648|Secondary|Mean Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Alternate compression arm) or 12 seconds (Simultaneous compression arm) were recorded. This is an automatically measured mean value of venous flow.|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec||Standard Deviation|Mean
1351364|NCT01779648|Secondary|Peak Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Under fixed state of other ultrasound scan parameters, peak velocity (PV) was measured by determination of maximum point of the augmented waveform.|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec||Standard Deviation|Mean
1351371|NCT01779219|Primary|Number of Participants Presenting With Complications|The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the operation, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological or clinical signs of the intracranial expansion.|Patients were followed for the duration of hospital stay (average 2 days) and again 2 weeks after the operation.|Complications assessed: Haematoma, Neurological deterioration, Infection|||participants|||Number
1351372|NCT01779167|Secondary|Response Duration of Subjects Treated With THRiL for WM|Measure response duration of patients enrolled on THRiL for WM|24 months|Data was not collected due to early termination.||||||
1351373|NCT01779167|Secondary|Time to Response|Measure the time from initiating therapy to demonstrating response in WM.|approximately 24 months|Data was not collected due to early termination.||||||
1351374|NCT01779167|Secondary|Rate of Rituximab Related IgM Flare|Estimate the rate of rituximab-related IgM flare|Approximately 24 months per patient|Data was not collected due to early termination.||||||
1351375|NCT01779167|Secondary|Survival of Subjects Treated With THRiL for WM.|Estimate overall survival of patients enrolled on THRiL for WM.|approximately 24 months per patient|Data was not collected due to early termination.||||||
1351376|NCT01779167|Secondary|Number of Adverse Events Experienced With Alternating Thalidomide and Lenalidomide Plus Rituximab for Subjects With Previously Treated Waldenstrom's Macroglobulinemia|Capture the number of adverse events experienced when combining thalidomide, lenalidomide, and rituximab in patients with previously treated WM|approximately 24 months per patient|Data was not collected due to early termination.||||||
1351377|NCT01779167|Primary|Number of Patients Who Demonstrate a Response (Complete, Partial, Minor) to Treatment|"Response criteria for subjects with WM is based upon the Consensus Panel Recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.~Overall response rate (CR + PR + MR) measured at time of best response."|Approximately 24 months||||participants|||Number
1351378|NCT01779024|Primary|Alcohol Infusions Self-administered|The total number of alcohol infusions self-administered.|120 minutes after the start of the infusion|The analyses included only those subjects who completed all types of infusions (Ghrelin and Placebo) and had alcohol self-administration|||Number of alcohol infusions||Standard Error|Mean
1351379|NCT01778985|Secondary|Estimated Blood Loss|Intraoperative estimated blood loss|Time of surgery, i.e. after 6-8 weeks of intervention|In both study arms, 13 participants did undergo surgery and, therefore, had an estimated blood loss value available for analysis. However, one patient each from both study arms did not have biopsies taken (technical considerations/ intraoperative decision or conversion from total to supracervical hysterectomy without ability to collect biopsy).|||mL||Standard Deviation|Mean
1351380|NCT01778985|Primary|Vaginal Wall Degradative Activity, Mucosa, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.|||Relative Units/mg protein||Standard Error|Mean
1351381|NCT01778985|Primary|TGFB1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
1351382|NCT01778985|Primary|Tropoelastin (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
1351383|NCT01778985|Primary|LOXL1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
1351384|NCT01778985|Primary|Lysyl Oxidase (LOX) (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
1351385|NCT01778985|Primary|hCOL3, (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Inter-Quartile Range|Median
1351386|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Per-Protocol)|Will assess vaginal wall histology - thickness of lamina propria|Time of surgery, i.e. 6-8 weeks of intervention||||microns||Standard Error|Mean
1351387|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Intention to Treat)|Will assess vaginal wall histology - thickness of lamina propria.|Time of surgery, i.e. after 6-8 weeks of intervention||||microns||Standard Error|Mean
1351388|NCT01778985|Secondary|Serum Estradiol Levels, Surgery||Time of surgery||||pg/mL||Standard Error|Mean
1351389|NCT01778985|Secondary|Serum Estradiol Levels, Baseline||Baseline||||pg/mL||Standard Error|Mean
1351390|NCT01778985|Secondary|Serum Estrone Levels, Surgery||Time of surgery||||pg/mL||Standard Error|Mean
1351391|NCT01778985|Primary|Vaginal Wall Degradative Activity, Muscularis, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.|||Relative Units/mg protein||Standard Error|Mean
1351392|NCT01778985|Primary|Total Collagen Content in Vaginal Muscularis, (Per-Protocol)|Will assess hydroxy-proline assays as index of amount of collagen|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||mg collagen per mg muscularis wet weight||Standard Error|Mean
1351393|NCT01778985|Secondary|Serum Estrone Levels, Baseline||Baseline||||pg/mL||Standard Error|Mean
1351394|NCT01778985|Primary|hCOL1A1, Per-Protocol|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||ratio||Inter-Quartile Range|Median
1351395|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Per-Protocol)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||microns||Standard Error|Mean
1351398|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Intention to Treat)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"|||microns||Standard Error|Mean
1351399|NCT01778855|Primary|Number of Participants With Recanalization|"To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition.~Additional data for secondary analyses were not acquired to permit analyses."|36 hours|Recanalization at 36 hours|||Participants|||Count of Participants
1351400|NCT01778751|Secondary|Depressive Symptoms|Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months|Baseline, 3m, 6m||||units on a scale||Standard Deviation|Mean
1351401|NCT01778751|Secondary|Self-reported Medication Adherence|Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m||||participants|||Number
1351402|NCT01778751|Secondary|Diabetes Self Care|Self-Care Inventory-revised as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m||||units on a scale||Standard Deviation|Mean
1351403|NCT01778751|Primary|Diabetes Control|Hemoglobin A1c as measured at baseline, 3m, 6m|Baseline, 3months, 6months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1351404|NCT01778634|Other Pre-specified|Number of Participants With Cardiac Arrhythmia|EKG evidence of prolonged QT (QTc > 450 ms)|3 days||||Participants|||Count of Participants
1351405|NCT01778634|Other Pre-specified|Number of Participants With Patent Ductus Arteriosus (PDA)|Detection of PDA by cardiac echocardiogram with left to right shunting, or clinical evidence of murmur, bounding pulses, and widened pulse pressure.|14 days|Participants who did not have PDA at baseline (prior to randomization). Participants with PDA at baseline were excluded from analysis (5 placebo and 5 azithromycin.|||Participants|||Count of Participants
1351406|NCT01778634|Other Pre-specified|Number of Participants With Periventricular Leukomalacia (PVL)|The number of subjects with cranial ultrasound confirmed PVL|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
1351407|NCT01778634|Other Pre-specified|Number of Participants With Severe Intraventicular Hemorrhage (IVH)|Grade III or IV IVH confirmed by cranial ultrasound|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks|The participants who had a Grade III or IV IVH at baseline (prior to randomization) were excluded (2 placebo and 4 Azithromycin).|||Participants|||Count of Participants
1351408|NCT01778634|Other Pre-specified|Number of Participants With Infections During the NICU Hospitalization|Culture-confirmed bacterial or fungal infection based on culture from sterile site (blood, cerebral spinal fluid, or urine)|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
1351409|NCT01778634|Other Pre-specified|Number of Participants With Necrotizing Enterocolitis (NEC)|Necrotizing enterocolitis ≥ Bell Stage II by radiographic and clinical criteria.|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
1351410|NCT01778634|Other Pre-specified|Number of Participants With Threshold Retinopathy of Prematurity (ROP)|Threshold ROP requiring surgical intervention as diagnosed by ophthalmologic examination|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks|The number of participants who survived to receive at least 1 eye exam for retinopathy of prematurity|||Participants|||Count of Participants
1351411|NCT01778634|Secondary|Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations|Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants.|Study day 1-day 7|No plasma samples from placebo group were analyzed for azithromycin concentrations|||serum conc outside predicted interval|number of serum samples concentrations||Number
1351412|NCT01778634|Secondary|Number of Participants Who Received Non-Study Antibiotics|Received Non-study antibiotics following study drug intervention period.|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
1351413|NCT01778634|Secondary|Number of Participants Who Received Postnatal Steroids|Receipt of steroid medications (hydrocortisone, dexamethasone)|36 weeks||||Participants|||Count of Participants
1351414|NCT01778634|Secondary|Number of Participants Who Experienced Air Leaks|Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks|The participants who had air leak at baseline (prior to randomization) were excluded from analysis (3 placebo and 5 azithromycin).|||Participants|||Count of Participants
1351415|NCT01778634|Secondary|Duration of Oxygen Supplementation|Receipt of supplemental oxygen|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||days||Inter-Quartile Range|Median
1351416|NCT01778634|Secondary|Duration of Positive Pressure Support|Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support.|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||days||Inter-Quartile Range|Median
1351417|NCT01778634|Secondary|Number of Participants Who Died|Mortality from any cause|22-26 months||||Participants|||Count of Participants
1351418|NCT01778634|Secondary|Number of Participants With Pulmonary Impairment|Parent report of recurrent wheezing and/or chronic cough|6-26 months||2020-01-31|01/2020||||
1351419|NCT01778634|Secondary|Number of Participants With Death or Neurodevelopmental Impairment|Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score <70.|22-26 months||2020-01-31|01/2020||||
1351420|NCT01778634|Secondary|Number of Participants Who Survived Until 36 Wks Postmenstrual Age That Were Diagnosed With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age|Physiologic definition of BPD based on oxygen-saturation monitoring|36 weeks post menstrual age (one month prior to due date)|Participants who survived until assessment timepoint 36 weeks post menstrual age (1 month before due date)|||Participants|||Count of Participants
1351421|NCT01778634|Primary|Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma|Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU).|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
1351422|NCT01778530|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For details, see the adverse event module.|5 months, 28 days||||participants|||Number
1351423|NCT01778530|Primary|Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105.|Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is >/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a >/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,|14 months|This outcome measure was not met due to termination of the study for poor accrual.||||||
1351424|NCT01778296|Secondary|Cold Intolerance|We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).|18 months to 24 months|||||||
1351425|NCT01778296|Primary|Discriminatory Sensation of the Flap|Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.|18 months to 24 months||||mm||Standard Deviation|Mean
1351426|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
1351427|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
1351428|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
1351429|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
1351430|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Newton meters (Nm)/kg||Standard Deviation|Mean
1351431|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup|The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks||||Pushups||Standard Deviation|Mean
1351432|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up|The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks||||Sit-ups||Standard Deviation|Mean
1351433|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip|The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.|Baseline and 24 weeks||||kg||Standard Deviation|Mean
1351434|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion|The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.|Baseline and 24 weeks||||degrees||Standard Deviation|Mean
1351435|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach|The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups|Baseline and 24 weeks||||cm||Standard Deviation|Mean
1351436|NCT01778127|Secondary|Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks|The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.|Baseline and 24 weeks||||ml/kg/min||Standard Deviation|Mean
1351437|NCT01778127|Primary|Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups|The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.|Baseline, Week 24||||minutes||Standard Deviation|Mean
1351438|NCT01778062|Secondary|Incidence of COPD Exacerbation|Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug|||Participants|||Number
1351439|NCT01778062|Secondary|Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.|||Score on a scale||Standard Deviation|Mean
1351440|NCT01778062|Secondary|St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment|The SGRQ-C contains 14 questions divided into two components. Part 1 produces “Symptoms” scores and Part 2 “Activity” and “Impacts” scores. 14 questions which are divided in three domains: “symptom” (question 1-7), “activity” (question 9, 12) and “impact” (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.|||Score on a scale||Standard Deviation|Mean
1351441|NCT01778062|Primary|Trough Forced Expiratory Volume in One Second Change|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.|||Liters||Standard Deviation|Mean
1351442|NCT01778049|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.|Baseline and 24 weeks|FAS (OC)|||mmol/L||Standard Error|Least Squares Mean
1351443|NCT01778049|Primary|Change From Baseline of HbA1c After 24 Weeks of Treatment.|"Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term “baseline” was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as “pre-treatment. Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.~Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial."|Baseline and 24 weeks|FAS (OC)|||Percentage of HbA1c||Standard Error|Least Squares Mean
1351444|NCT01778023|Secondary|Ht-V (Height Velocity)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.|At the first 6 months and the last 6 months in group A|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.|||cm/year||95% Confidence Interval|Least Squares Mean
1351445|NCT01778023|Secondary|Occurrence of Adverse Events|AEs were collected throughout the trial in both groups.|Throughout the trial (12 months)|Safety analysis set – includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.|||events|||Number
1351446|NCT01778023|Secondary|Change in Bone Age|Change in bone age from the baseline to 6 months.|After 6 months of treatment.|Safety analysis set (SAS) :includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.|||years||Standard Deviation|Mean
1351447|NCT01778023|Secondary|Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)|IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.|||mcg/mL||Standard Error|Least Squares Mean
1351448|NCT01778023|Secondary|Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)|IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.|||ng/ml||Standard Error|Least Squares Mean
1351449|NCT01778023|Secondary|Change in Ht-SDS (Height Standard Deviation Score)|Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.|||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
1351450|NCT01778023|Primary|Height Velocity (Ht-V)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.|After 6 months of treatment|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.|||cm/year||Standard Error|Least Squares Mean
1351451|NCT01778010|Secondary|Heart Rate|Values for heart rate as a function of cocaine dose and modafinil maintenance condition.|48 days|Eight patients participated in each condition in a within-subjects fashion.|||BPM||Standard Error|Mean
1351452|NCT01778010|Secondary|Drug Quality Cluster|"Visual analogue scale ratings on the ‘Drug Quality’ cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The Drug Quality Cluster consisted of three items:~the choice was of high quality~the choice was potent~I liked the choice Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome."|48 days|Eight subjects participants in each condition in a within-subjects fashion.|||units on a scale||Standard Error|Mean
1351453|NCT01778010|Primary|Cocaine Self-administration|The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.|48 days|Eight patients contributed to each condition, in a within-subjects manner.|||Number of doses purchased||Standard Error|Mean
1351454|NCT01777997|Secondary|Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)|Grading uses the Division of AIDS (DAIDS) 2004 (clarification 2009) Severity of Adverse Events Table, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.|From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation|All participants who initiated ART, regardless of ART status at time of event|||participants|||Number
1351455|NCT01777997|Secondary|Change in Quality of Life (QoL) Index|"QoL index was obtained by averaging the five responses on the Euro-Quality of Life questionnaire (EQ-5D), where a response of 0 indicates no problems/no discomfort, 1 indicates some problems/moderate discomfort and 2 indicates unable to perform activities/extreme discomfort. Change equals each specific week index, respectively, minus the baseline index (mean of the two averages obtained prior to the start of ART)"|From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||units on a scale||Inter-Quartile Range|Median
1351456|NCT01777997|Secondary|Change in Levels of D-dimer|Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||log10(ng/mL)||Inter-Quartile Range|Median
1351457|NCT01777997|Secondary|Change in Levels of Interleukin (IL)-6|Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||log10(pg/mL)||Inter-Quartile Range|Median
1351458|NCT01777997|Secondary|Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)|Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||% of CD4+ T-cells||Inter-Quartile Range|Median
1351459|NCT01777997|Secondary|Change in Levels of CD8+ T-cell Activation|Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||% of CD8+ T-cells||Inter-Quartile Range|Median
1351460|NCT01777997|Secondary|Change in CD4+ T-cell Count|Change equals each specific week CD4+ T-cell count, respectively, minus the baseline CD4+ T-cell count (mean of the two measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||cells/mm^3||Inter-Quartile Range|Median
1351480|NCT01777932|Primary|Progression Free Survival|Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
1351461|NCT01777997|Secondary|Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay|At a specific week, the proportion of participants with HIV-1 RNA by iSCA less than assay limit of detection (0.6 copies/mL)|At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||proportion of participants|||Number
1351462|NCT01777997|Primary|Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART|Mean change from baseline (pre-ART [study entry] and week 0 on ART [study week 12]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE)|From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to week 24 or 48 weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||% of CD8+ T-cells||95% Confidence Interval|Mean
1351463|NCT01777945|Secondary|Number of Participants With Adverse Events||approximately 2 years|46 participants enrolled in the study were evaluable with regards to tolerability; however, 1 participant did not meet the eligibility criteria, was excluded from the efficacy analyses, but was included in the safety analyses.|||participants|||Number
1351464|NCT01777945|Secondary|Percentage of Capecitabine Dose Modifications||approximately 2 years||||percentage of doses|||Number
1351465|NCT01777945|Secondary|Duration of Treatment With Xeloda||approximately 2 years||||treatment cycle||Standard Deviation|Mean
1351466|NCT01777945|Secondary|Clinical Benefit Rate|The percentage of participants with an overall response (complete or partial remission) or with stable disease.|approximately 2 years||||percentage of participants|||Number
1351467|NCT01777945|Secondary|Overall Response Rate|The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.|approximately 2 years||||percentage of participants|||Number
1351468|NCT01777945|Secondary|Time to Treatment Failure|The time from enrollment to discontinuation of any drug of the treatment combination.|approximately 2 years||||months||Standard Deviation|Mean
1351469|NCT01777945|Primary|Progression-free Survival (PFS)|The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.|approximately 2 years||||months||Standard Deviation|Median
1351470|NCT01777932|Secondary|Participants With Proteinuria at Study Entry (Baseline)|The number of participants with proteinurea status as positive, negative or missing is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure|||participants|||Number
1351471|NCT01777932|Secondary|Participants With Type of Metastases at Study Entry (Baseline)|The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
1351472|NCT01777932|Secondary|Participants With Disease History at Study Entry (Baseline)|Participant’s history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
1351473|NCT01777932|Secondary|Participants With Prior Therapy at Study Entry (Baseline)|The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure|||participants|||Number
1351474|NCT01777932|Secondary|Participants With Eastern Cooperative Oncology Group Status at Study Entry|The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
1351475|NCT01777932|Secondary|Participants With Tumor Stage at Diagnosis|Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
1351476|NCT01777932|Secondary|Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry|PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status.|Approximately 5 years|All enrolled participants were considered for this outcome measure. Out of the total 220 enrolled participants, 106 participants were triple negative, 110 were not triple negative and data for 4 participants were missing.|||months||95% Confidence Interval|Median
1351477|NCT01777932|Secondary|Participants With Hormone Receptor Status at Diagnosis|The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
1351478|NCT01777932|Secondary|Time to Discontinuation (TTD) of Bevacizumab Treatment|Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
1351479|NCT01777932|Secondary|One Year Survival|The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.|Approximately 5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
1352116|NCT01769443|Secondary|Incidence of Severe Infection Requiring Intravenous Antibiotics||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351481|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Racc|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
1351482|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Tmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
1351483|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
1351484|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmin|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
1351485|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: AUCtau|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
1351486|NCT01777776|Secondary|Phase II - Overall Survival (OS)|"OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
1351487|NCT01777776|Secondary|Phase Ib/II - Duration Of Response (DOR)|"DOR is calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
1351488|NCT01777776|Secondary|Phase Ib/II - Progression Free Survival (PFS)|"PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
1351489|NCT01777776|Secondary|Phase Ib/II - Overall Response Rate (ORR)|"ORR is defined as the proportion of patients with a best overall response of complete response or partial response.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
1351490|NCT01777776|Secondary|Phase Ib/II - Plasma Concentration-time Profiles|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to plasma concentration time profiles were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
1351491|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Serious Adverse Event (SAE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.|||participants|||Number
1351492|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Adverse Event (AE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.|||participants|||Number
1351493|NCT01777776|Primary|Phase II - Objective Response Rate (ORR)|"As per RECIST v1.1, ORR is defined as the proportion of patients with a best overall response of complete response or partial response.~Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
1351494|NCT01777776|Primary|Phase II - Progression Free Survival (PFS)|"As per RECIST v1.1, PFS is the time from date of randomization/ start of treatment to the date of event defined as the first documented progression or death due to any cause.~Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
1351495|NCT01777776|Primary|Phase Ib - Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1|"Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818.~Due to the halt of enrollment, no Maximum Tolerated Dose (MTD) was formally declared during the study."|Cycle 1 (approximately 28 days)|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.|||participants with DLTs|||Number
1351978|NCT01772576|Secondary|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.|3 months through 15 months post implant|156 patients remained after 3 months in the study without lead related complication. Those were used for the secondary endpoint.|||percentage of total participants||95% Confidence Interval|Number
1351496|NCT01777763|Other Pre-specified|Number of Participants Discontinuing Study Treatment Due to an AE|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. These AEs resulted in participants stopping study drug treatment. This measure includes participants who discontinued due to AEs and also includes treatment failures that were attributed to AEs.|Up to Day 28|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1351497|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Related AEs|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-related AEs were considered by the investigator to be related to the study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1351498|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-emergent AEs are any events not present before starting study drug treatment or any events that were present before treatment that worsened in either intensity or frequency after exposure to study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1351499|NCT01777763|Other Pre-specified|Number of Participants Surviving at Day 65|Number of Participants Alive at Day 65|Day 65|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1351500|NCT01777763|Primary|Apparent Total Body Clearance (CL/F) for Posaconazole Tablet|Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The CL/F PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through predose on the Day 8 steady-state visit.|||L/hr||Standard Deviation|Mean
1351501|NCT01777763|Primary|Time to Maximum Concentration (Tmax) of Posaconazole Tablet|Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Tmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||Hours||Full Range|Median
1351502|NCT01777763|Primary|Maximum Concentration (Cmax) of Posaconazole Tablet|Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||ng/mL||Standard Deviation|Mean
1351503|NCT01777763|Primary|Minimum Concentration (Cmin) of Posaconazole Tablet|Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous day's dose of study drug.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmin PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||ng/mL||Standard Deviation|Mean
1351504|NCT01777763|Primary|Average Concentration (Cavg) of Posaconazole Tablet|"Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval.~Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose."|Predose on Day 1 up to 24 hours postdose on Day 8|The Cavg PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||ng/mL||Standard Deviation|Mean
1351505|NCT01777620|Secondary|Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS|The Investigator assessed the severity of the patient’s CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.|Baseline, Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351506|NCT01777620|Secondary|Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS|The Investigator assessed the severity of the patient’s glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.|Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351563|NCT01777321|Primary|Anti-gE Antibody Concentrations||Before vaccination (PRE), at two months after dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||Standard Deviation|Median
1351507|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351508|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351509|NCT01777620|Secondary|Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351510|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351511|NCT01777620|Secondary|Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351512|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351513|NCT01777620|Secondary|Percentage of Participants Satisfied With Treatment of Crow’s Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351514|NCT01777620|Primary|Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)|Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
1351515|NCT01777581|Secondary|State-trait Anxiety Inventory (STAI)|"Self-report evaluation of anxiety symptoms.Assessment of subjective symptoms of current anxiety and chronic anxiety.~There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” Trait anxiety items include: “I worry too much over something that really doesn’t matter” and “I am content; I am a steady person.” All items are rated on a 4-point scale~Scale~1= almost never 4= almost always~Higher scores indicate greater anxiety. Mean cumulative scores were reported"|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1351516|NCT01777581|Secondary|Beck Depression Inventory (BDI-II)|"Self-report evaluation of depressive symptoms.The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression. The higher the score the degree of depression."|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1351517|NCT01777581|Secondary|Neuropathic Pain Questionnaire|"Self-report evaluation of nerve pain symptoms. A low total cumulative score means less pain and higher cumulative score is greater pain.~Total cumulative scores range form 0 to 1000 where in 0 is absence of pain and 1000 highest pain."|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1351566|NCT01777321|Primary|Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations ≥ 18 mIU/mL||Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1351518|NCT01777581|Secondary|Oswestry Low Back Pain Disability Questionnaire|"Self report evaluation of various back pain symptoms. For each of 10 sections participants rate pain on a scale of 0-5 in these categories:~Section 1 – Pain intensity~Section 2 – Personal care~Section 3 – Lifting~Section 4 – Walking~Section 5 – Sitting~Section 6 – Standing~Section 7 – Sleeping~Section 8 – Sex life (if applicable)~Section 9 – Social life~Section 10 – Travelling~The scores are combined form each category into overall score. Scores are converted to percentages as follows:~0% to 20%: minimal disability: The patient can cope with most living activities.~21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing.~41%-60%: severe disability: Pain remains the main problem-activities of daily living are affected.~61%-80%: crippled: Back pain impinges on all aspects of life.~81%-100%: Patients are either bed-bound or exaggerating their symptoms"|baseline and 10 weeks||||percent score||Standard Deviation|Mean
1351519|NCT01777581|Secondary|SF-36 (Short Form)|"Self-report of quality of life. Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.~Scoring: Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores reflect higher quality of life with 100 high life quality. Total mean cumulative scores were reported~The eight sections are:~vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health"|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1351520|NCT01777581|Secondary|VAS Related to Nociceptive Pain Component (VAS-Noc)|The secondary outcome is change in pain VAS from baseline through 1o weeks as related to nociceptive pain component. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative scores were reported|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1351521|NCT01777581|Primary|Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)|The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
1351522|NCT01777542|Secondary|Quantitative Measures of Respiration: Apnea Index|"Respiratory data was collected using non-invasive respiratory inductance plethysmography from a BioCapture® recording device. BioCapture® is a child-friendly measurement device that can record from 1 to 12 physiological signal transducers in a time-locked manner. It can be configured with the pediatric chest and abdominal plethysmography bands and the 3 lead ECG signals we plan to use for monitoring cardiac safety throughout the study. Each transducer is placed on the patient independently to provide a customized fit that yields the highest signal quality for each patient irrespective of body shape and proportion. The transducer signals captured by the BioCapture® are transmitted wirelessly to a laptop computer where all signals are displayed in real-time.~The apnea index is given as apneas/hour. Data on apneas greater than or equal to 10 seconds are displayed below. The higher the frequency of apnea, the more severe the breathing abnormality."|Every 10 weeks during each of the two 20-week treatment periods|"In some cases, the number of participants analyzed is less than 15 for each group due to inability to complete testing session.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||Apneas/Hour||Inter-Quartile Range|Median
1351523|NCT01777542|Secondary|Aberrant Behavior Checklist – Community Edition (ABC-C)|"The ABC-C is a global behavior checklist implemented for the measurement of drug and other treatment effects in populations with intellectual disability. Behavior based on 58 items that describe various behavioral problems.~Each item is rated on the parents perceived severity of the behavior. The answer options for each item are:~0 = Not a problem~= Problem but slight in degree~= Moderately serious problem~= Severe in degree~The measure is broken down into the following subscales with individual ranges as follows:~Subscale I (Irritability): 15 items, score range = 0-45 Subscale II (Lethargy): 16 items, score range = 0-48 Subscale III (Stereotypy): 7 items, score range = 0-21 Subscale IV (Hyperactivity): 16 items, score range = 0-48 Subscale V (Inappropriate Speech) was not included in the breakdown because it was not applicable (no participants in the study had verbal language)."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351524|NCT01777542|Secondary|Communication and Symbolic Behavior Scales – Developmental Profile (CSBS-DP)|"The CSBS-DP was designed to measure early communication and symbolic skills in infants and young children (that is, functional communication skills of 6 month to 2 year olds). The CSBS-DP measures skills from three composites: (a) Social (emotion, eye gaze, and communication); (b) Speech (sounds and words); and (c) Symbolic (understanding and object use) and asks about developmental milestones. The data reported are the composite scores for these three categories.~The possible scores for the three composite categories are as follows:~Social Composite = 0-48; Speech Composite = 0-40; Symbolic Composite = 0-51.~A higher score indicates more advanced abilities in that area."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351564|NCT01777321|Primary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|At two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1351525|NCT01777542|Secondary|Vineland Adaptive Behavior Scales, Second Edition (VABS-II)|"The VABS-II is a survey designed to assess personal and social functioning. Within each domain (Communication, Daily Living Skills, Socialization, and Motor Skills), items can given a score of 2 if the participant successfully performs the activity usually; a 1 if the participant successfully performs the activity sometimes, or needs reminders; a 0 if the participant never performs the activity, and a DK if the parent/caregiver is unsure of the participant's ability for an item.~The raw scores in each sub-domain are reported and the ranges for these are as follows: [Communication Domain], Receptive Language=0-40, Expressive Language=0-108, Written Language=0-50; [Daily Living Skills Domain], Personal=0-82, Domestic=0-48, Community=0-88; [Socialization Domain], Interpersonal Relationships=0-76, Play and Leisure Time=0-62, Coping Skills=0-60; [Motor Skills Domain]: Gross Motor Skills=0-80, Fine Motor Skills=0-72.~A higher score indicates more advanced abilities."|At the start and end of each 20-week treatment period|"One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351526|NCT01777542|Secondary|Mullen Scales of Early Learning (MSEL)|"The MSEL is a standardized developmental test for children ages 3 to 68 months consisting of five subscales: gross motor, fine motor, visual reception, expressive language, and receptive language.~The raw score is reported for each subscale domain. The potential score ranges are as follows:~Visual Reception: 33 items, score range=0-50, Fine Motor: 30 items, score range= 0-49, Receptive Language: 33 items, score range= 0-48, Expressive Language: 28 items, score range= 0-50. The gross motor subscale was not included in this population.~A higher raw score indicates more advanced abilities in that section."|At the start and end of each 20-week treatment period|"One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point.~In some cases, the number of participants analyzed is less than 15 for each group due to subject's inability or unwillingness to complete the testing."|||units on a scale||Inter-Quartile Range|Median
1351527|NCT01777542|Secondary|Anxiety, Depression, and Mood Scale (ADAMS)|"Remaining subscales of the ADAMS that are not primary outcome measures include: Manic/hyperactive, Depressed mood, General anxiety, Obsessive/compulsive behavior.~The range for each subscale is as follows:~Manic/Hyperactive Behavior: 0-15 Depressed Mood: 0-21 General Anxiety: 0-21 Obsessive/Compulsive Behavior: 0-9~The higher the score for each subscale, the more problematic the behavior."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351528|NCT01777542|Secondary|Rett Syndrome Behavior Questionnaire (RSBQ)|"The RSBQ is a parent-completed measure of abnormal behaviors typically observed in individuals with RTT. Each item, grouped into eight subscales, is scored on a Likert scale of 0-2, according to how well the item describes the individual’s behavior. A score of “0” indicates the described item is “not true,” a score of “1” indicates the described item is “somewhat or sometimes true,” and a score of “2” indicates the described item is “very true or often true.”~The total sum of each subscale is reported. The higher the score, the more severe the symptoms of that subscale in the participant.~The range for each subscale is as follows:~General Mood: 0-16 Body rocking and expressionless face: 0-14 Hand behaviors: 0-12 Breathing Problems: 0-10 Repetitive Face Movements: 0-8 Night-time behaviors: 0-6 Walking Standing: 0-4~The fear/anxiety subscale was used as a primary outcome measure in this study and results can be found in that section."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351529|NCT01777542|Primary|Kerr Clinical Severity Scale|"The Kerr clinical severity scale (Kerr scale) is a quantitative measure of global disease severity. The Kerr scale is a summation of individual items related to Rett syndrome phenotypic characteristics. The items are based on the severity or degree of abnormality of each characteristic on a discrete scale (0, 1, 2) with the highest level corresponding to the most severe or most abnormal presentations.~The possible range of scores is 0-48. The higher the score, the more severe the symptoms."|At the start and end of each 20-week treatment period|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351530|NCT01777542|Primary|Parent Targeted Visual Analog Scale (PTSVAS) - Scale 3|"The parent or caretaker identifies the three most troublesome, RTT-specific, “target” symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
1351565|NCT01777321|Primary|Anti-gE Antibody Concentrations||Before vaccination (PRE), two months after Dose 1 (M2) and three months after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1351613|NCT01776645|Other Pre-specified|Qualitative Measures|Qualitative analysis of interviews|Baseline and end of 9-week treatment protocol|||||||
1351614|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Neff's Self-Compassion Scale|Baseline and end of 9-week treatment protocol|||||||
1351531|NCT01777542|Primary|Parent Targeted Visual Analog Scale (PTSVAS) - Scale 2|"The parent or caretaker identifies the three most troublesome, RTT-specific, “target” symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
1351532|NCT01777542|Primary|Parent Targeted Visual Analog Scale (PTSVAS) - Scale 1|"The parent or caretaker identifies the three most troublesome, RTT-specific, “target” symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
1351533|NCT01777542|Primary|Parental Global Impression – Improvement (PGI-I)|"As part of each visit after the study intervention was initiated, the parent/caregiver was asked to compare the patient's overall clinical condition to the score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"Data was not collected at visit 1 because participants had not yet been exposed to either intervention.~In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms."|||units on a scale||Inter-Quartile Range|Median
1351534|NCT01777542|Primary|Parental Global Impression – Severity (PGI-S)|"The PGI-S is the parent version of the CGI-S. Parents/caregivers/LAR are asked to rate the severity of their child’s symptoms at baseline on a 7-point scale from not at all impaired to the most impaired. The parents/caregivers/LAR will complete the PGI-S at each study visit.~The scores that correspond to each possible grouping are as follows:~1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
1351535|NCT01777542|Primary|Clinical Global Impression – Improvement (CGI-I)|"Each time the patient was seen after the study intervention was initiated, the clinician compared the patient's overall clinical condition to the CGI-S score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7."|Every 10 weeks during each of the two 20-week treatment periods|"Data was not collected at Visit 1 because participants had not yet been exposed to either intervention.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351536|NCT01777542|Primary|Clinical Global Impression – Severity (CGI-S)|"This scale is used to judge the severity of the subject’s disease prior to entry into the study. The clinician will rate the severity of behavioral symptoms at baseline on a 7-point scale from not impaired to the most impaired.~The scores that correspond to each possible grouping are as follows: 1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7."|Every 10 weeks during each of the two 20-week treatment periods|"One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
1351537|NCT01777542|Primary|Anxiety, Depression, and Mood Scale (ADAMS) - Social Avoidance Subscale|"The ADAMS is completed by the parent/caregiver/LAR and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The instructions ask the rater to describe the individual's behavior over the last six months on the following scale: 0 if the behavior has not occurred, 1 if the behavior occurs occasionally or is a mild problem, 2 if the behavior occurs quite often or is moderate problem, or 3 if the behavior occurs a lot or is a severe problem.~The Social Avoidance subscale of the ADAMS will be used as a primary outcome measure for this trial. The range for this subscale is 0-21. The higher the subscale score, the more problematic the behavior."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
1351615|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by Ryff's psychological well-being scales|Baseline and end of 9-week treatment protocol|||||||
1351616|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the Hospital Anxiety and Depression Scale|Baseline and end of 9-week treatment protocol|||||||
1351538|NCT01777542|Primary|Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale|"The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual’s behavior. A score of “0” indicates the described item is “not true,” a score of “1” indicates the described item is “somewhat or sometimes true,” and a score of “2” indicates the described item is “very true or often true.”~The total sum of items in each subscale is reported.~For the fear/anxiety subscale, the sum total could be between 0-8. The higher the sum total score, the greater the frequency of fear/anxiety behaviors."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
1351539|NCT01777438|Secondary|Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis|"ARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis.~Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR"|3 years after diagnosis||||percentage of participants|||Number
1351540|NCT01777438|Primary|Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation.|Visual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points.|3 years after diagnosis||||Score on a scale||Standard Deviation|Mean
1351541|NCT01777438|Secondary|Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment|Based on the proposed cut-off value of VAS < 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients|3 years after starting SCIT||||percentage of participants|||Number
1351542|NCT01777438|Primary|Current Medication Use Three Years After Diagnosis of AR|Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group)|3 years after starting SCIT||||percentage of participants|||Number
1351543|NCT01777425|Other Pre-specified|Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group|"VAS scores: a measurement of patient’s subjective evaluation by indicating a position on a line between two endpoints. Patients will score eight individual symptoms on a scale from 0 until 10, being 0 no trouble and 10 maximum trouble. Finally a mean symptom score will be calculated per symptom.~The SNOT-22 questionnaire is a validated 22 item questionnaire. patients indicate how much they are affected in eight different areas and identify the 5 most important items. The SNOT-22 total score can range from 0 to 110, with higher scores representing worse quality of life.~Perceived health status can be evaluated by the 36-item short-form (SF-36). It consists of 36 items covering eight domains. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability"|three years after ESS||||units on a scale||Standard Deviation|Mean
1351544|NCT01777425|Secondary|Control Nasal Endoscopy|Evaluating of difference in control if nasal endoscopy is performed three years after ESS.|3 years after ESS|fully controlled status with endoscopic evaluation|||percentage of participants|||Number
1351545|NCT01777425|Primary|Control Status of Patients With Rhinosinusitis|1. Percentage of patients with rhinosinusitis that are fully controlled, partly controlled and uncontrolled according to the new european position paper on rhinosinusitis (EPOS) definitions at a mean interval of 3 years after endoscopic sinus surgery.|3 years after FESS||||percentage of participants|||Number
1351546|NCT01777412|Primary|Follow-Up Expanded Disability Status Score (EDSS)|"EDSS~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Follow-up visit 91 days after admission||||units on a scale||Inter-Quartile Range|Median
1351547|NCT01777412|Primary|Safety Assessment and Side Effects|Frequency and severity of adverse events and side effects. Serious adverse events are considered those which are life threatening, lead to hospitalization and related to the drug. Side effects are considered minor effects of the experimental drug that do not significantly impact the care of the patient with the experimental drug.|91 days||||participants|||Number
1351548|NCT01777412|Primary|Baseline Expanded Disability Status Score (EDSS)|"EDSS~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Admission to hospital||||units on a scale||Inter-Quartile Range|Median
1351549|NCT01777334|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as the WM value at that visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1351550|NCT01777334|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 140, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes (min) pre-dose and 5 min pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hr after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 value at that visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessmentsmade 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug during the Treatment Period. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1351551|NCT01777321|Secondary|Number of Subjects With SAEs||Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1351552|NCT01777321|Secondary|Number of Subjects With pIMDs||Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1351553|NCT01777321|Secondary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|Twelve Months after Dose 2 (M14)|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.|||Subjects|||Number
1351554|NCT01777321|Secondary|Anti-gE Antibody Concentrations||At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1351555|NCT01777321|Secondary|Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL||At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.|||Subjects|||Number
1351556|NCT01777321|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 30 days post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1351557|NCT01777321|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1351558|NCT01777321|Primary|Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)||Up to 30 days post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1351559|NCT01777321|Primary|Number of Days With General Symptoms||During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days||Inter-Quartile Range|Mean
1351560|NCT01777321|Primary|Number of Days With Local Symptoms||During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days||Inter-Quartile Range|Mean
1351561|NCT01777321|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature >39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1351562|NCT01777321|Primary|Number of Subjects With Solicited Local Symptoms|The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1351617|NCT01776645|Primary|Change in Chronic Pain Acceptance Questionnaire||Baseline and end of 9-week treatment protocol|||||||
1351567|NCT01777282|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to <Week 12 or >=230 mg/dL (>=12.8 mmol/L) from >=Week 12 to <Week 52.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.|||Weeks||Standard Deviation|Mean
1351568|NCT01777282|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population|||Kilograms (kg)||Standard Deviation|Mean
1351569|NCT01777282|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only those participants with valid post-Baseline results (within 14 days of last exposure to treatment) were analyzed.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1351570|NCT01777282|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population|||Percentage of participants|||Number
1351571|NCT01777282|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population: all enrolled participants who received at least 1 dose of study medication and who had at least one HbA1c post-Baseline assessment.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1351572|NCT01777282|Primary|Number of Participants With Any Hypoglycemic Event|Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.|||Participants|||Number
1351573|NCT01777282|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.|||Participants|||Number
1351574|NCT01777269|Secondary|Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent|Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 12|ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|||Scores on a scale||Standard Error|Least Squares Mean
1351575|NCT01777269|Secondary|Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points|Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1351576|NCT01777269|Secondary|Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months|Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline, Week 2, Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1351577|NCT01777269|Secondary|Change From Baseline in Quality of Life (BPH Impact Index –BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months|The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1351578|NCT01777269|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months|The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1351579|NCT01777269|Secondary|Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months|Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Deviation|Mean
1351580|NCT01777269|Secondary|Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months|Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1351581|NCT01777269|Secondary|Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months|Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1351582|NCT01777269|Secondary|Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months|Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where “+” indicates improvement and “-”indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test|Baseline and 12 months|ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).|||Participants|||Number
1351583|NCT01777269|Secondary|Change From Baseline in Scores From the Full Men’s Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months|Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, and 9|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1351584|NCT01777269|Primary|Changes From Baseline (BL) in Total Score From the Full Men’s Sexual Health Questionnaire (MSHQ) at 12 Months|Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)|Baseline and 12 months|Intent-to-Treat (ITT): All randomized par. regardless of whether or not treatment was administered. Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
1351585|NCT01777217|Primary|Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).|The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.|baseline and 16 weeks||||Scores on a scale||Standard Deviation|Median
1351586|NCT01777191|Secondary|SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)|"The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from Strongly Disagree to Strongly Agree). 1 represents Strongly Disagree while 7 represents Strongly Agree. The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit."|Baseline, Week 4 and Week 8|All randomized participants.|||units on a scale||Standard Deviation|Mean
1351587|NCT01777191|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received a least 1 dose of study drug during the Treatment Period and had evaluable data.|||percentage of participants|||Number
1351588|NCT01777191|Secondary|Percentage of Device Operation Failures|Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.|Baseline through Week 12|All randomized participants.|||percentage of incomplete injections|Participants||Number
1351589|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1351590|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1351591|NCT01777191|Secondary|Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)|PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1351647|NCT01776008|Other Pre-specified|Serum Estradiol Levels||At baseline, following 4 weeks of anastrozole alone, day 1 of course 3, and at pre-surgery|Data was not collected.||||||
1351592|NCT01777191|Secondary|PK: AUC 0-tlast by Body Weight|AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: <80 kg, Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.|||µg*day/mL||90% Confidence Interval|Geometric Mean
1351593|NCT01777191|Secondary|PK: Cmax by Body Weight|Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: <80 kilogram (kg), Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.|||µg/mL||95% Confidence Interval|Geometric Mean
1351594|NCT01777191|Secondary|PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)|AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.|||µg*day/mL||90% Confidence Interval|Geometric Mean
1351595|NCT01777191|Secondary|PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)|Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.|||µg/ml||90% Confidence Interval|Geometric Mean
1351596|NCT01777191|Primary|PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device|AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.|||micrograms*day/milliliter (µg*day/mL)||90% Confidence Interval|Geometric Mean
1351597|NCT01777191|Primary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device|Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.|||micrograms/milliliter (µg/mL)||90% Confidence Interval|Geometric Mean
1351598|NCT01777126|Secondary|Severity Grade of Postoperative Complications.|Severity grade of postoperative complications (POCs) was compared between the two groups. The severity grade of POCs were classified using the Clavien-Dindo Classification. Per patient, multiple complications are possible.|30 days postoperative||||number of POCs per severity grade|||Number
1351599|NCT01777126|Secondary|The Type of Postoperative Complications.|The type of postoperative complications (POCs) were compared between the two groups. The type of POCs were classified using the Clavien-Dindo Classification. Herein POCs were classified into 8 categories (1. Infection, 2. Fistula/leak, 3. Bleeding/hematoma, 4. Gastrointestinal, 5. Cardiopulmonary, 6. Neurologic, 7. pain and 8. Other) and stratified by their severity grade (Table 2). Per patient, multiple complications are possible.|30 days postoperative||||number per type of POC|||Number
1351600|NCT01777126|Secondary|Patients With a Catheter Related Bloodstream Infection|Patients with a catheter related bloodstream infection were compared between the two groups|30 days postoperative||||participants|||Number
1351601|NCT01777126|Secondary|The Number of Postoperative Complications Per Patient.|The number of postoperative complications per patient was compared between the two groups.|30 days postoperative||||number of postoperative complications||Inter-Quartile Range|Median
1351602|NCT01777126|Secondary|Patients With One or More Postoperative Complication.|Number of patients with one or more postoperative complication were compared betweent the two groups.|30 days postoperative||||participants|||Number
1351603|NCT01777126|Secondary|The Time to Resumption of Full Diet.|The time to resumption of full diet between the two groups was compared.|30 days postoperative||||day||Inter-Quartile Range|Median
1351604|NCT01777126|Secondary|Number of Administered PN|Number of administered PN per group|30 days postoperative||||number of PN|||Number
1351605|NCT01777126|Secondary|Successful Implementation Rate of the ONP in the Experimental Group|Successful implementation of the ONP was achieved if the patient followed the protocol and did not need PN.|30 days postoperative|The number of patients with successful implementation of the ONP in the experimental group.|||participants|||Number
1351606|NCT01777126|Primary|the Postoperative Length of Stay|The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home.|one month after surgery|Primary outcome measure was interval from surgery to discharge. Discharge means that the patient returns back to his home and not to a rehabilitation center.|||day||Inter-Quartile Range|Median
1351607|NCT01776645|Secondary|Change in Brief Pain Inventory|Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes|Baseline to end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain|||units on a scale||Standard Deviation|Mean
1351608|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Pommier's Compassion for Other's Scale|Baseline and end of 9-week treatment protocol|||||||
1351609|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Compassionate Love Scale adapted for close other|Baseline and end of 9-week treatment protocol|||||||
1351610|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by PROMIS Global Health Scale|Baseline and end of 9-week treatment protocol|||||||
1351611|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the PROMIS Social Isolation Scale|Baseline and end of 9-week treatment protocol|||||||
1351612|NCT01776645|Other Pre-specified|Change in Emotional Distress|As Assessed by the PROMIS Anger Scale|Baseline and end of 9-week treatment protocol|||||||
1351618|NCT01776645|Primary|Change in Brief Pain Inventory|Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable|Baseline and end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain|||units on a scale||Standard Deviation|Mean
1351619|NCT01776554|Secondary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 9 to <18 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351620|NCT01776554|Secondary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 3 to <9 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351621|NCT01776554|Secondary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 6 to <36 months achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351622|NCT01776554|Secondary|Percentages Of Subjects Aged 9 to <18 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 9 to <18 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351623|NCT01776554|Secondary|Percentages Of Subjects Aged 3 to <9 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 3 to <9 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351624|NCT01776554|Secondary|Percentages Of Subjects Aged 6 to <36 Months, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 6 to <36 months, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351625|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 9 to <18 Years.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 9 to <18 years is reported.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
1351626|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 3 to <9 Years.|"Immunogenicity was measured as geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 3 to <9 years is reported.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
1351648|NCT01776008|Other Pre-specified|Proportion of Patients Whose Ki67 Values is at Most 10%|A 95% binomial confidence intervals will be constructed for the true proportion of patients whose pre Akt inhibitor MK2206 ki67 value is at most 10% as well as for the true proportion of patients with a C1D17 Ki67 value that is at most 10% among those patients whose pre Akt inhibitor MK2206 Ki67 was more than 10%.|From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone|Data was not collected.||||||
1351627|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 6 to <36 Months.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 6 to <36 months is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
1351628|NCT01776554|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination; SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset.|||Number of subjects|||Number
1351629|NCT01776554|Primary|Number of Subjects (≥6 Years – 17 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset.|||Number of subjects|||Number
1351630|NCT01776554|Primary|Number of Subjects (6 Month - <6 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after each vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1351631|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 9 to <18 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351632|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 3 to <9 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351633|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 6 to <36 months, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done was FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351634|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 9 to <18 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351635|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 3 to <9 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
1351649|NCT01776008|Other Pre-specified|Percent Change in the Apoptotic Index||From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone|Data was not collected.||||||
1351650|NCT01776008|Other Pre-specified|Change in Ki67 Levels||From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone|Data was not collected||||||
1351636|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 6 to <36 months, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually received at least one dose of study vaccination and provided at least one evaluable serum sample both before (baseline) and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
1351637|NCT01776541|Secondary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as: a) for subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) for subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS set.|||Percentages of subjects||95% Confidence Interval|Number
1351638|NCT01776541|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS set.|||Percentages of subjects||95% Confidence Interval|Number
1351639|NCT01776541|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5 for subjects 18-60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS set.|||Ratio||95% Confidence Interval|Geometric Mean
1351640|NCT01776541|Primary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1351641|NCT01776541|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.|Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1351642|NCT01776541|Primary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.~Seroconversion is defined as either a) in subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion for the adult population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS population.|||Percentages of subjects||95% Confidence Interval|Number
1351643|NCT01776541|Primary|Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
1351644|NCT01776268|Primary|Concentration of APPs After Oral Priming|Saliva will be sampled 24-48 hours after the 5-days of oral priming is completed. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.|days 7-9 of life||||femtomole (fmol)||Inter-Quartile Range|Mean
1351645|NCT01776268|Primary|Concentration of APPs Before Oral Priming|Saliva will be sampled on day 1-2 of life prior to oral priming. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.|days 1-2 of life||||femtomole (fmol)||Inter-Quartile Range|Mean
1351646|NCT01776008|Other Pre-specified|The Pharmacodynamic Effect of Akt Inhibitor MK2206 in Combination With Anastrozole on the PI3K Pathway Activities, Assessed by Phosphoroproteomics and Immunohistochemistry Analysis on Serial Tumor Biopsies||Up to 3 weeks following the last dose of Akt inhibitor MK-2206|Data was not collected.||||||
1351651|NCT01776008|Secondary|Radiological Response Rate|The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on radiographic evaluation (mammogram or ultrasound) divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.|Baseline and completion of cycle 4 (28 day cycles)|Due to missing pre-surgical scans, this endpoint could not be evaluated.||||||
1351652|NCT01776008|Secondary|Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. For this endpoint, we are reporting the number of patients that reported a grade 3 or higher graded adverse event during neoadjuvent treatment. A complete list of all reported adverse events is in the Adverse Events section of the report.|Baseline to end of Cycle 4 (28 day cycles)|All patients that registered and began neoadjuvant treatment were included in this analysis.|||Participants|||Count of Participants
1351653|NCT01776008|Secondary|Clinical Response Rate|The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on physical examination divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.|Baseline to end of Cycle 4 (28 day cycles)|Due to missing bi-dimensional measurements, clinical response could not be determined.||||||
1351654|NCT01776008|Primary|Pathological Complete Response Rate|Any woman whose Ki67 value ≤10% on cycle 1 day 17 of combination treatment who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pathological complete response (pCR). A ninety percent confidence interval for the true pathologic complete response rate will be calculated using the Duffy-Santer approach.|At time of surgery (up to 3 weeks after 4, 28-day cycles)|All patients beginning protocol therapy and evaluable for primary endpoint were included in this analysis.|||participants|||Number
1351655|NCT01775995|Other Pre-specified|Pain Sensitivity to Experimental Thermal Stimuli|Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.|0, 8, 26 weeks|||||||
1351656|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.~Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.~Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|From enrollment to 26 week follow-up (6 months)|One meditation-CBT participant did not provide data at 8-week follow-up; two participants (one meditation-CBT, one control) did not provide data at 26-week follow-up. All 35 participants were included in the analysis; missing participant data was imputed based on existing data for the given participant.|||dollars||Standard Deviation|Mean
1351657|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.~Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.~Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|6 months prior to baseline, to baseline (enrollment)||||dollars||Standard Deviation|Mean
1351658|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure)."|baseline to 26 weeks|Six Meditation-CBT participants and one Wait-list Control participant did not provide biological data at 26 week follow-up. Results for this measure are based on the number of participants analyzed.|||mg/dL||95% Confidence Interval|Mean
1351659|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure)."|baseline to 8 weeks|Three Meditation-CBT participants did not provide biological data at 8 week follow-up. Results for this measure are based on the number of participants analyzed.|||mg/dL||95% Confidence Interval|Mean
1351660|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351661|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351662|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351663|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351664|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351665|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351666|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351667|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351668|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351669|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351670|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351671|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351672|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using drugs|||Number
1351673|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using drugs|||Number
1351674|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline||||percentage using drugs|||Number
1351675|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using alcohol|||Number
1351676|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using alcohol|||Number
1351677|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline||||percentage using alcohol|||Number
1351678|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||morphine-equivalent mg/day||95% Confidence Interval|Mean
1351679|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||morphine-equivalent mg/day||95% Confidence Interval|Mean
1351680|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||percentage disability||95% Confidence Interval|Mean
1351681|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||percentage disability||95% Confidence Interval|Mean
1351682|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351683|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
1351684|NCT01775865|Other Pre-specified|Tissue Doppler Left Ventricular Relaxation Velocity (E')|Left ventricular diastolic dysfunction|Change from baseline E' at 4 weeks|Data were not obtained because cardiac echos could not be performed in participants because of lack of equipment||||||
1351685|NCT01775865|Secondary|Brachial Artery Flow-mediated Dilation (FMD)|Endothelial function|Change from baseline brachial artery FMD at 4 weeks|After baseline measurements, there were 3 dropouts in salsalate group and 1 FMD that was not able to be anayzed (poor image quality) for a total of 10 in salsalate for FMD. There was 1 dropout in the placebo group and 2 FMDs not analyzed (poor image quality) for a total of 11 analyzed in placebo for FMD.|||Percent dilation||Standard Error|Mean
1351686|NCT01775865|Primary|Carotid-femoral Pulse Wave Velocity (CFPWV)|Aortic stiffness|Change in CFPWV from baseline at 4 weeks|After baseline measurements, there were 3 dropouts in salsalate group for a total of 11 completed in salsalate, and 1 dropout in the placebo group for a total of 13 completed in placebo.|||cm/sec||Standard Error|Mean
1351687|NCT01775852|Secondary|Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up.|"The WHODAS contains 36 items on functioning and disability with a recall period of 30 days covering 7 domains: Understanding and Communicating (6 items), Getting around (5 items), Self-care (4 items), Getting along with others (5 items), Life activities: household (4 items), Life activities: work/school (4 items), and Participation in society (8 items). Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do).~WHODAS domain scores are computed for each domain by adding the item responses together. A global score is then computed by summing all domains together, and transforming them into a range from 0 to 100, with higher scores indicating higher levels of disability (0= no disability, 100= full disability)."|Change at 12 week follow-up from baseline||||units on a scale||Standard Error|Mean
1351688|NCT01775852|Secondary|Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up.|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.~The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|Change at 12 week follow-up from baseline||||units on a scale||Standard Error|Mean
1351689|NCT01775852|Secondary|Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.|"The HDI is useful in assessing the impact of headache, and its treatment, on daily living. 25 self-report items are rated with answers as Yes (4 points), Sometimes (2 Points), and No (0 points). All items are then added together to create an overall score which can range from 0 (no impact), to 100 (severe impact) of headache on daily life.~A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects."|12 week change from baseline||||units on a scale||Standard Error|Mean
1351690|NCT01775852|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale at 12 week (3 month) follow-up from baseline.~Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|12 week change from baseline||||units on a scale||Standard Error|Mean
1351691|NCT01775787|Primary|Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use|To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use.|7-10 days|Nicotine Concentrations Before and 5 Minutes After Ecig Use were intended to be analyzed, regardless of flavor, as pre-specified in the study protocol,|||ng/ml||Standard Error|Mean
1351692|NCT01775774|Secondary|Mortality at Hospital Discharge|The number of patients expired at hospital discharge.|From study enrollment to Hospital discharge||||participants|||Number
1351693|NCT01775774|Secondary|Hospital Survival to Day 60|The number of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.|60 days after randomization||||participants|||Number
1351694|NCT01775774|Secondary|ICU Free Days to Day 28||28 days after study enrollment||||day||Full Range|Median
1351695|NCT01775774|Secondary|Duration of Vasopressor Use (Days)|Days on vasopressor to day 28 after study enrollment|28 days||||day||Full Range|Median
1351715|NCT01775553|Primary|Safety and Efficacy of High Dose Carfilzomib|The safety and efficacy of high dose carfilzomib who developed disease progression on the standard dosing and schedule of carfilzomib as measured by number of participants with adverse events|up to 4 years||||Participants|||Count of Participants
1351696|NCT01775774|Secondary|Ventilator Free Days at Study Day 28|Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.|time of initiating unassisted breathing to day 28||||day||Full Range|Median
1351697|NCT01775774|Secondary|Incidence of Severe Adverse Events (SAEs)|The number of participants with a severe adverse event during the study was assessed.|Investigators conducted daily assessments for the presence of adverse events (AE) from enrollment through study day 28 or hospital discharge, whichever occurred first.||||participants|||Number
1351698|NCT01775774|Primary|Incidence of Pre-specified Infusion Associated Adverse Events|"Any of the following occurring within 6 h of mesenchymal stem-cell infusion:~Addition of a third vasopressor or an increase in vasopressor dose greater than or equal to the following:~Norepinephrine: 10 μg per min~Phenylephrine: 100 μg per min~Dopamine: 10 μg/kg per min~Epinephrine: 0·1 μg/kg per min~Hypoxaemia requiring an increase in the fraction of inspired oxygen of ≥0·2 and increase in positive end-expiratory airway pressure level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88–95%~New cardiac arrhythmia requiring cardioversion~New ventricular tachycardia, ventricular fi brillation, or asystole~A clinical scenario consistent with transfusion incompatibility or transfusion-related infection~Cardiac arrest or death within 24 h of mesenchymal stem-cell infusion"|24 hours||||participants|||Number
1351699|NCT01775722|Primary|Percent Change in Blanching of Port Wine Stain|Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1–fB2)/fB1.|8 weeks|Each subject received both treatments on their corresponding test sites. We compared response of test sites to different treatment.|||percentage|Test site|Standard Deviation|Mean
1351700|NCT01775670|Primary|Average Pain 2 Months After Enrollment|Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.|At 2 months after enrollment|Subjects did not complete the pain scale questionnaire at the follow up visit.||||||
1351701|NCT01775670|Secondary|Thumb Grip Strength|Grip strength of the affected hand was measured at enrollment using a dynamometer. The subject squeezes the handle of the dynamometer to maximum capability to measure grip strength. Each subject completed the grip strength measurement 3 times on the affected hand to get an average grip strength of the affected hand.|At Enrollment||||pounds||Standard Deviation|Mean
1351702|NCT01775670|Secondary|Thumb Pinch Strength|Measurement of thumb pinch strength using a pinch meter. Subjects place the pinch meter between their thumb and index finger and pinch down to record the pinch strength.|At Enrollment||||pounds||Standard Deviation|Mean
1351703|NCT01775670|Secondary|Thumb MCP in Pinch Position (Degrees)|Measurements of thumb MCP in pinch position.|At Enrollment|The measurement of the thumb MCP joint in a pinch position was the same, 10 degrees, for the 2 subjects in the OT splint group, therefore the standard deviation is 0.|||degrees||Standard Deviation|Mean
1351704|NCT01775670|Secondary|Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)|Measurements of thumb metacarpophalangeal (MCP) joint in resting position.|At Enrollment||||degrees||Standard Deviation|Mean
1351705|NCT01775670|Secondary|PROMIS Pain – Interference|A computerized assessment of pain interference measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|At Enrollment||||T score||Standard Deviation|Mean
1351706|NCT01775670|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS) – Depression|A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|At Enrollment|The data was not recorded for the 1 patient randomized to the off-the-shelf group.|||T score||Standard Deviation|Mean
1351707|NCT01775670|Primary|Average Satisfaction With the Splint 2 Months After Enrollment|Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.|At 2 months after enrollment||||units on a scale||Standard Deviation|Mean
1351708|NCT01775670|Primary|Thumb Pain at Enrollment|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At enrollment||||units on a scale||Standard Deviation|Mean
1351709|NCT01775670|Primary|Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.|2 months after enrollment|The one subject in the off-the-shelf group was lost to follow up.|||units on a scale||Standard Deviation|Mean
1351710|NCT01775670|Primary|Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At enrollment||||units on a scale||Standard Deviation|Mean
1351711|NCT01775553|Secondary|Markers of ER Stress|The markers of ER stress signaling (both apoptotic and prosurvival) in MM cells from patients in this study and to determine if the balance of apoptotic versus prosurvival signaling changes upon recapture of response with carfilzomib dose escalation relative to the time of study entry.|up to 4 years|data not collected||||||
1351712|NCT01775553|Secondary|Duration of Response to High Dose Carfilzomib||up to 4 years||||months||Full Range|Median
1351713|NCT01775553|Secondary|Overall Response Rate (ORR)|Overall Response Rate defined in categories|up to 4 years||||Participants|||Count of Participants
1351714|NCT01775553|Secondary|Progression Free Survival (PFS)||up to 4 years||||months||Full Range|Median
1351716|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)|Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurement was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported.|Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
1351717|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)|End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator’s discretion.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
1351718|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in Vital Sign Examinations|Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate. Criteria for clinically significant change in any vital sign examination was based on investigator’s discretion.|Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
1351719|NCT01775189|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
1351720|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1351721|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol|Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1351722|NCT01775189|Other Pre-specified|Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1351723|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1351724|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone|Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1351780|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
1351725|NCT01775189|Other Pre-specified|Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1351726|NCT01775189|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.|||hours||Standard Deviation|Mean
1351727|NCT01775189|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.|||hours||Standard Deviation|Mean
1351728|NCT01775189|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
1351729|NCT01775189|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.|||hours||Full Range|Median
1351730|NCT01775189|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1351731|NCT01775189|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the pharmacokinetic (PK) parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1351732|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)|Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem “as bad as can be”). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||hours||Full Range|Median
1351733|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour|Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem “as bad as can be”). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||units on a scale*hours||Standard Deviation|Mean
1351734|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Peak Effect (Emax)|Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem “as bad as can be”). Emax = Maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||units on a scale||Standard Deviation|Mean
1351735|NCT01775189|Other Pre-specified|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351977|NCT01772576|Other Pre-specified|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant|3 Months through 24 Months Post-Implant|Patients remaining after the 3 months follow-up in the study until the 24 months follow-up.|||percentage of all participants||95% Confidence Interval|Number
1351736|NCT01775189|Other Pre-specified|High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351737|NCT01775189|Other Pre-specified|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351738|NCT01775189|Other Pre-specified|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351739|NCT01775189|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours||Full Range|Median
1351740|NCT01775189|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours*mm||Standard Deviation|Mean
1351741|NCT01775189|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose PD data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||mm||Standard Deviation|Mean
1351742|NCT01775189|Secondary|Percentage of Dose (Drug Powder) Insufflated|The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period.|Intervention period: 0 Hour post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||percentage of dose||Standard Deviation|Mean
1351743|NCT01775189|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351744|NCT01775189|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351745|NCT01775189|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351746|NCT01775189|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351747|NCT01775189|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351748|NCT01775189|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351749|NCT01775189|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351750|NCT01775189|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351751|NCT01775189|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351752|NCT01775189|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351753|NCT01775189|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351754|NCT01775189|Secondary|Feel Sick: Peak Effect (Emax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351755|NCT01775189|Secondary|Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351756|NCT01775189|Secondary|Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351979|NCT01772576|Primary|Complication Free Rate|Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.|3-months follow-up|Patients enrolled in the study and having received the RELIANCE 4FRONT active fixation lead|||percentage of all subjects||95% Confidence Interval|Number
1351757|NCT01775189|Secondary|Bad Drug Effects: Peak Effect (Emax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351758|NCT01775189|Secondary|Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351759|NCT01775189|Secondary|Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351760|NCT01775189|Secondary|Good Drug Effects: Peak Effect (Emax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351761|NCT01775189|Secondary|Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
1351762|NCT01775189|Secondary|Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351763|NCT01775189|Secondary|Any Drug Effects: Peak Effect (Emax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351764|NCT01775189|Secondary|Overall Drug Liking Effect at Hours 12 and 24|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”).|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351765|NCT01775189|Secondary|Overall Drug Liking: Mean Effect (Emean)|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”). Emean = Average observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351766|NCT01775189|Secondary|Overall Drug Liking: Peak Effect (Emax)|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”). Emax = Maximum observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351767|NCT01775189|Secondary|Take Drug Again Effect at Hours 12 and 24|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”).|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351768|NCT01775189|Secondary|Take Drug Again: Mean Effect (Emean)|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emean = Average observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351769|NCT01775189|Secondary|Take Drug Again: Peak Effect (Emax)|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emax = Maximum observed score.|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351770|NCT01775189|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351771|NCT01775189|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351772|NCT01775189|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
1351773|NCT01775189|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
1351774|NCT01775137|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalisation, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.|||Number of participants|||Number
1351775|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The day of first hospitalization due to serious respiratory related adverse events was analysed using Kaplan Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
1351776|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The total number of hospitalisation days due to serious respiratory-related adverse events was analysed using Kaplan-Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Days||Full Range|Median
1351777|NCT01775137|Secondary|Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the extension study.|Baseline of extension study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
1351778|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics in Extension Study|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
1351779|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively|||Days||Full Range|Median
1351781|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Absolute change was calculated by using the formula = (Value at actual time point - start of extension value).|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||log10 CFU||Standard Deviation|Mean
1351782|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant’s age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted – baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percent change in FEV1 % predicted||Standard Deviation|Mean
1351783|NCT01775137|Secondary|Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. Relative change in FEV1 % predicted was calculated by using the formula = 100 *(30-min post-dose value - pre-dose value) / pre-dose value.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percent change in FEV1 % predicted||Standard Deviation|Mean
1351784|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The day of first hospitalization due to serious respiratory-related adverse events was analysed using Kaplan Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
1351785|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed using Kaplan-Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Days||Full Range|Median
1351786|NCT01775137|Secondary|The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
1351787|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
1351788|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Days||Full Range|Median
1351789|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
1351790|NCT01775137|Secondary|Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles|MIC was defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation. Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested (mucoid,dry and small colony variant biotypes).|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||micrograms/milliliters|||Number
1351791|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Absolute change was determined using the formula = (Post-baseline value- baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day||||log 10 CFU/g||Standard Deviation|Mean
1351792|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant’s age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted – baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percent change in FEV1 % predicted||Standard Deviation|Mean
1351793|NCT01775137|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in core study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.|||Participants|||Number
1351794|NCT01775124|Secondary|Duration of Active Treatment Phase up to Month 24||up to month 24|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
1351795|NCT01775124|Secondary|Duration of Active Treatment Phase Prior to Month 12||Prior to month 12|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
1351796|NCT01775124|Secondary|Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12|This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group.|prior to month 12|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
1351797|NCT01775124|Secondary|Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24|This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption|up to month 24|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
1351798|NCT01775124|Secondary|Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24|Optical coherence tomography(OCT) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (LOCF)= last observation carried forward|||microns||Standard Deviation|Mean
1351799|NCT01775124|Secondary|Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for Month 12 and Month 24 whether a patient had a VA score of 73 or more letters|Month 12 and 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Patients|||Number
1351800|NCT01775124|Secondary|Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Patients|||Number
1352117|NCT01769443|Secondary|Incidence of Initiation of Any Mechanical Circulatory Support Device||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351801|NCT01775124|Secondary|Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24|Visual acuity (VA) was at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Patients|||Number
1351802|NCT01775124|Secondary|Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline|Baseline to 24 months|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||letters||Standard Deviation|Mean
1351803|NCT01775124|Secondary|Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
1351804|NCT01775124|Secondary|Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.|Month 3 to month 4 through Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
1351805|NCT01775124|Primary|Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.|Month 3 to month 4 through Month 12|Full Analysis Set: Consisted of all patients to whom study treatment was assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
1351806|NCT01774981|Secondary|Part B: Change From Baseline in Albuminuria Over Time|Albuminuria is defined as the ratio of albumin to creatinine.|Baseline, 19 Weeks|All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.|||mg/dl of albumin/ by mg/dl of creatinine||Standard Deviation|Mean
1351807|NCT01774981|Secondary|Part B: Change From Baseline in Proteinuria Over Time|Proteinuria is defined as the ratio of protein to creatinine.|Baseline, 19 Weeks|All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.|||mg/dl of protein/ by mg/dl of creatinine||Standard Deviation|Mean
1351808|NCT01774981|Primary|Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline up to 32 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1351809|NCT01774981|Primary|Part B:Change From Baseline in Proteinuria|Proteinuria is defined as the ratio of protein to creatinine.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug in Part B with a baseline measurement and at least one post-baseline measurement.|||grams per 12 hour (g/12 hour)||Standard Deviation|Mean
1351810|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.|||kg||Standard Error|Least Squares Mean
1352748|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1351811|NCT01774968|Secondary|Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or >2.0 U/kg). The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.|||percentage of participants|||Number
1351812|NCT01774968|Secondary|Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.|||events per participant per 30 days||Standard Deviation|Mean
1351813|NCT01774968|Secondary|Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1351814|NCT01774968|Secondary|Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)|The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
1351815|NCT01774968|Secondary|Change From Baseline to Week 24 in Number of Insulin Injections|The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R. Last observation carried forward (LOCF) was used to impute missing postbaseline values.|||injections per day||Standard Deviation|Mean
1351816|NCT01774968|Secondary|Percentage of Participants With Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.|||percentage of participants|||Number
1351817|NCT01774968|Secondary|Time to Reach HbA1c Target Values|The cumulative number of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% is summarized at Weeks 6, 12, 18, and 24. The number of participants at risk (n) is also provided for each target value and timepoint.|Baseline through 6, 12, 18, and 24 weeks.|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data|||participants|||Number
1351818|NCT01774968|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable FPG data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1351819|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.|||units per kilogram (units/kg)||Standard Error|Least Squares Mean
1351820|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.|||units||Standard Error|Least Squares Mean
1351821|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
1351822|NCT01774968|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.|||events per participant per 30 days||Standard Deviation|Mean
1351823|NCT01774968|Secondary|Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24|The percentage of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.|Week 24|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data.|||percentage of participants|||Number
1351824|NCT01774968|Primary|Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1351825|NCT01774929|Secondary|Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30|The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Baseline, Day 15 and Day 30|"ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. N” signifies those participants who were evaluated for this outcome measure."|||Units on a scale||Standard Deviation|Mean
1351826|NCT01774929|Primary|Pain Intensity Score at Day 30|The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.|||cm||Standard Deviation|Mean
1351827|NCT01774929|Primary|Pain Intensity Score at Day 15|The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.|Day 15|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.|||cm||Standard Deviation|Mean
1351828|NCT01774903|Secondary|Number of Participants With Participant Global Assessment|Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=Mild, 3=Moderate, 4=Severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|PP population included all participants who completed the 30-day study.|||participants|||Number
1351829|NCT01774903|Secondary|Number of Participants With Investigator Global Assessment|Investigator completed a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|Per protocol (PP) population included all participants who completed the 30-day study.|||participants|||Number
1351830|NCT01774903|Primary|Pain Intensity at Day 30|Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
1351831|NCT01774903|Primary|Pain Intensity at Day 15|Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 15|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
1351832|NCT01774851|Primary|Progression Free Survival (PFS)|Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.|30 months||||weeks||95% Confidence Interval|Median
1351833|NCT01774786|Secondary|Cmin of Trastuzumab||Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||μg/mL||Standard Deviation|Mean
1351834|NCT01774786|Secondary|Minimum Serum Concentration (Cmin) of Pertuzumab||Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||μg/mL||Standard Deviation|Mean
1352749|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1351835|NCT01774786|Secondary|Cmax of Trastuzumab||Post-dose (0.5 hour after end of 30-60 minutes infusion) on D1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||μg/mL||Standard Deviation|Mean
1351836|NCT01774786|Secondary|Maximum Serum Concentration (Cmax) of Pertuzumab||Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day (D1) of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||micrograms per milliliter (μg/mL)||Standard Deviation|Mean
1351837|NCT01774786|Secondary|Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score|The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. A positive value means an increase, while a negative values means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).|Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)|Participants in the ITT population (includes all randomized participants, regardless of whether study medication was received) with both a baseline assessment and at least 1 post-treatment assessment are included in the analysis.|||score on a scale||Standard Deviation|Mean
1351838|NCT01774786|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score|The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).|Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)|Participants in the ITT population (includes all randomized participants, regardless of whether study medication was received) with both a baseline assessment and at least 1 post-treatment assessment are included in the analysis.|||score on a scale||Standard Deviation|Mean
1351839|NCT01774786|Secondary|Percentage of Participants With Left Ventricular Systolic Dysfunction (LVSD, Symptomatic or Asymptomatic)|Left ventricular systolic dysfunction may either be asymptomatic or have symptoms of heart failure. It is characterized by dilation of the left ventricle and vasoconstriction.|Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years|The safety population included all participants who received any amount of any study medication.|||percentage of participants|||Number
1351840|NCT01774786|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years|The safety population included all participants who received any amount of any study medication.|||percentage of participants|||Number
1351841|NCT01774786|Secondary|Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria|Clinical benefit rate is defined as best response of CR or PR or stable disease for 6 weeks or longer, as determined by the investigator using RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters while on study. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be >/=15 mm in short axis when assessed by CT scan.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.|||percentage of participants|||Number
1351842|NCT01774786|Secondary|Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria|Duration of objective response is defined as the time from first occurrence of documented objective response to documented disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Objective response: PR or CR occurring on 2 consecutive occasions ≥4 weeks apart. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. Measurable disease defined as tumor lesions with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node, it must be ≥15 mm in short axis when assessed by CT scan.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The participants with measurable disease at baseline who achieved a documented objective response, according to RECIST v1.1 criteria.|||months||95% Confidence Interval|Median
1351843|NCT01774786|Secondary|Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria|Overall objective response (partial response [PR] or complete response [CR]) occurring on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.|||Percentage of participants|||Number
1351844|NCT01774786|Secondary|Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria|Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 millimeters (mm) in the sum of diameters of target lesions; the appearance of one or more new lesions.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The ITT population included all randomized participants, regardless of whether study medication was received.|||months||95% Confidence Interval|Median
1351845|NCT01774786|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause.|Baseline up to death (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The intent-to-treat (ITT) population included all randomized participants, regardless of whether study medication was received.|||Months||95% Confidence Interval|Median
1351846|NCT01774604|Secondary|Number of Patients With 30 Days Hospital Re-admission|Number of patients admitted to the hospital for any cause following ERCP|From randomization until 30 days after ERCP||||participants|||Number
1351847|NCT01774604|Secondary|Number of Patient Deaths|Number of patients who died from any cause from the time of ERCP until 30 days post-procedure|From randomization to 30 days after ERCP||||participants|||Number
1351848|NCT01774604|Secondary|Number of Patients Who Developed Gastrointestinal Bleeding|Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure|From randomization to 30 days after ERCP||||participants|||Number
1351849|NCT01774604|Secondary|Number of Patients Who Developed Mild Pancreatitis|Number of patient who developed mild acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP||||participants|||Number
1351850|NCT01774604|Secondary|Number of Patients Who Developed Moderately Severe Pancreatitis|Number of patients with moderately severe pancreatitis based on Atlanta Classification|From randomization to 30 days after ERCP||||participants|||Number
1351851|NCT01774604|Secondary|Number of Patients Who Developed Severe Pancreatitis|Number of patients with severe acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP|Assess the number of patients who developed severe acute pancreatitis|||participants|||Number
1351852|NCT01774604|Primary|Number of Patients Who Developed Acute Pancreatitis|Number of patients who developed pancreatitis following ERCP based on Atlanta Classification|From randomization to 30 days after ERCP|Patient who randomized into the study and received either rectal indomethacin or placebo|||participants|||Number
1351853|NCT01774591|Primary|24-hour BP (Diastolic)|To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.|26 weeks||||mmHg||Standard Deviation|Mean
1351854|NCT01774591|Secondary|Difference in 24-hour Urine Aldosterone Change From Baseline|To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females|26 weeks||||percentage of changes||Standard Deviation|Mean
1351855|NCT01774591|Primary|24-hour BP (Systolic)|To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.|26 weeks||||mmHg||Standard Deviation|Mean
1351856|NCT01774344|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)||||percentage of subjects|||Number
1351857|NCT01774344|Secondary|Objective Tumor Response Rate (ORR)|Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non target lesions and no appearance of new lesions. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)||||percentage of subjects|||Number
1352118|NCT01769443|Secondary|Incidence of Removal From Transplant Waiting List for Any Reason Except Improvement of Cardiac Function||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351858|NCT01774344|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks)||||days||95% Confidence Interval|Median
1351859|NCT01774344|Secondary|Time to Progression (TTP)|TTP was the time (days) from randomization to radiological or clinical disease progression assessed by independent radiological review. Median and 95% confidence interval were reported for the modified response evaluation criteria in solid tumors (mRECIST) and response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)||||days||95% Confidence Interval|Median
1351860|NCT01774344|Primary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization (Day 1) of the first subject until 419 days later||||days||95% Confidence Interval|Median
1351861|NCT01774305|Secondary|Emergence Time|The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.|from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)||||sec||Standard Deviation|Mean
1351862|NCT01774305|Primary|Coughing Grade|The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).|from the time of eye opening to 5 min after extubation||||units on a scale||Standard Deviation|Mean
1351863|NCT01774253|Secondary|Determine the Response Rates of Participants Based on Activation (or no Activation) of Their Hedgehog Signaling Pathway|To determine the objective response rates (partial and complete response) for patients without and with evidence of activation of Hedgehog signaling pathway in their tumors|3 years|No samples collected for hedgehog pathway. No data exists.||||||
1351864|NCT01774253|Secondary|Evaluate the Impact of Quality of Life of Children Receiving Vismodegib Using PedsQL Questionnaires|Evaluate the impact of Quality of Life of children receiving Vismodegib using PedsQL questionnaires|2 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
1351865|NCT01774253|Secondary|Determine the Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|2 years|Not evaluated due to early closure. Study data does not exist.||||||
1351866|NCT01774253|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety and tolerability of Vismodegib as a single agent in pediatric and young adult patients with refractory or recurrent pontine glioma|2 years||||participants|||Number
1351867|NCT01774253|Primary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|5 years||||Days||Full Range|Median
1351868|NCT01774149|Other Pre-specified|Empowerment|Diabetes Empowerment Scale-Short Form (DES-SF) will be used to assess empowerment at the start of the study (week 1 post-enrollment) and during week 12 of intervention.|Up to 12 weeks post-enrollment.|||||||
1351869|NCT01774149|Other Pre-specified|Usability|System Usability Scale (SUS) will be applied to assess usability of the approach and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment|||||||
1351870|NCT01774149|Secondary|Change in HbA1c|HbA1c will be measured at the start of the study (week 1 post-enrollment) and during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment|11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded.|||Percentage points||95% Confidence Interval|Mean
1351871|NCT01774149|Primary|Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.|The number of self-measured blood glucose values < 4 mmol/L (72 mg/dL) or > 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.|Up to 12 weeks post-enrollment|14 participants in each group were active users and had sufficient data to be analyzed for the outcome.|||Events||95% Confidence Interval|Mean
1351872|NCT01774110|Other Pre-specified|Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment|The 6-Minute Walk Test is a test of walking endurance and walking velocity.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment||||feet||Standard Deviation|Mean
1351873|NCT01774110|Secondary|Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.|The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke. There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section. Each section is scored independently and is normed to 100 points. Each of the 3 sections is then combined into a total overall function score which is also normed to 100. Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment||||scores on a scale||Standard Deviation|Mean
1351874|NCT01774110|Primary|Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment|Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.|This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.||||cm/sec||Standard Deviation|Mean
1351875|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)-Ability to Climb Stairs Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 100. The measure represents the placebo adjusted average change in WIQ ability to climb stairs score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs|||scores on a scale||Standard Deviation|Mean
1351876|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)- Walking Speed Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 87. The measure represents the placebo adjusted average change in WIQ walking speed score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs|||scores on a scale||Standard Deviation|Mean
1351877|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)-Walking Distance Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0.2, maximum 100. The measure represents the placebo adjusted average change in WIQ walking distance score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs.|||scores on a scale||Standard Deviation|Mean
1351878|NCT01774097|Secondary|Peripheral Artery Questionnaire (PAQ)|The Peripheral Artery Questionnaire (PAQ) assesses subjective physical limitations, leg symptoms, social function, treatment satisfaction, and quality of life. It is administered as a self report. Higher scores are indicative of better outcome. The summary scores is compiled by taking the mean of five subscales generated from the original questions. Range: Minimum score is 11.1, maximum 85. The measure represents placebo adjusted average change in Peripheral Artery Questionnaire (PAQ) summary score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month PAQs.|||scores on a scale||Standard Deviation|Mean
1351879|NCT01774097|Secondary|Peak Walking Time (PWT)|The average change in maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.|Assessed at baseline and 3 months|Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.|||minutes||Standard Deviation|Mean
1351880|NCT01774097|Secondary|Claudication Onset Time (COT)|Claudication Onset Time (COT) is the walking time at which patients first experience leg pain during a treadmill test. The measure represents placebo adjusted average change over time (in minutes) in the time walked by a patient on a treadmill under standardized conditions before the onset of claudication symptoms, regardless of whether this is manifested or characterized as muscle pain, ache, cramp, numbness or fatigue. This does not include joint pain or other pain not associated with claudication. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.|||minutes||Standard Deviation|Mean
1351881|NCT01774097|Secondary|Post-exercise Ankle-Brachial Index (ABI)|ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Post-exercise ABI is collected routinely with the patient supine immediately following a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants with available analyzable ABI at baseline, 3 months, and 6 months|||ratio||Standard Deviation|Mean
1351882|NCT01774097|Secondary|Pre-exercise Ankle-Brachial Index (ABI)|ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Pre-exercise ABI is collected routinely with the patient supine immediately prior to a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants with available analyzable ABI data at baseline, 3 months, and 6 months|||ratio||Standard Deviation|Mean
1351883|NCT01774097|Primary|Capillary Perfusion|The placebo adjusted average change in capillary perfusion over time.|Assessed at baseline and 6 months|Participants with available analyzable MRI imaging at baseline and 6 months|||percent||Standard Deviation|Mean
1351884|NCT01774097|Primary|Peak Hyperemic Popliteal Flow (Phase Contrast MRA)|The placebo adjusted average change in peak hyperemic popliteal flow (mL/s) over time.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month MRI imaging|||ml/sec||Standard Deviation|Mean
1351885|NCT01774097|Primary|Leg Collateral Count (Via Contrast Enhanced-MR)|The placebo adjusted average change in the number of collateral vessels over time.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month MRI imaging|||vessel count||Standard Deviation|Mean
1352119|NCT01769443|Secondary|Incidence of Death||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351886|NCT01774097|Primary|Peak Walking Time (PWT)|The placebo adjusted average change over time in the maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month treadmill test results.|||minutes||Standard Deviation|Mean
1351887|NCT01774084|Secondary|Change in Beta Cell Function|Beta cell function is measured with intravenous glucose tolerance test (IVGTT)|Morning before surgery and up to two days after surgery||||Insulin AUC nmol * min/L||Standard Deviation|Mean
1351888|NCT01774084|Primary|Change in Insulin Sensitivity|Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp|Morning before surgery and up to two days after surgery|Per protocol|||mg/(kg min)||Standard Deviation|Mean
1351889|NCT01774045|Primary|Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.|baseline to 72 hours||||participants|||Number
1351890|NCT01774045|Primary|Number of Dose Limiting Toxicity of Laboratory Values|Laboratory tests are composed of hematology and blood chemistry and measured at each visit. Hematology are composed of RBC, WBC, platelets, hematocrit, hemoglobin, prothrombin time (PT) and partial thromboplastin time (aPTT). Blood chemistry are composed of AST, ALT, LDH, total bilirubin, BUN, serum creatinine, free thyroxine (FT4), TSH, sodium, calcium, potassium, glucose, LDL, HDL, cholesterol and HbA1c.|baseline to 72 hours||||participants|||Number
1351891|NCT01774045|Primary|Number of Dose Limiting Toxicity of Vital Sign|Vital sign, including heart rate, blood pressure and body temperature, are measured at each visit and at 1,2,3,4,8,12 and 24 hours after drug administration.|baseline to 72 hours||||participants|||Number
1351892|NCT01774045|Primary|Number of Dose Limiting Toxicity of Electrocardiograph|Electrocardiograph (ECG) is measured at each visit. At visit 2, subjects were measured at 1,2, 4, 8, 12 and 24 hours after drug administration.|baseline to 72 hours||||participants|||Number
1351893|NCT01774045|Primary|Number of Dose Limiting Toxicity of Physical Examination|Physical examination, including skin, head, neck, eyes, ears, nose, throat, heart, lungs, abdomen (liver and spleen), neurological examination, lymph node and extremities, is measured at each visit from screening to follow-up.|baseline to 72 hours||||participants|||Number
1351894|NCT01773954|Other Pre-specified|Change in Total Thickness at the Foveal Center Point on OCT||Baseline to Week 52||||micrometers||95% Confidence Interval|Mean
1351895|NCT01773954|Primary|Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score||Baseline to Week 52||||letters||95% Confidence Interval|Mean
1351896|NCT01773889|Primary|Clinical Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR.~Failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have been written to avoid stopping therapy prematurely without compromising patient safety, to accommodate the uncertainties of assessing failure in this setting. The criteria as written are based on sound medical, scientific and ethical principles. The trial is further designed to help establish the utility of these novel criteria."|every 3 months until the date of first documented progression or date of death from any cause, assessed up to 2 years when study terminated early||||participants|||Number
1351897|NCT01773473|Secondary|Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 1,5-AG measurements.|||micrograms/milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
1351898|NCT01773473|Secondary|Insulin Dose at Week 26|Insulin dose is the total daily dose including basal and prandial doses.|Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had Week 26 insulin dose measurement.|||units of insulin per day (IU/day)||Standard Deviation|Mean
1351899|NCT01773473|Secondary|Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005].|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug.|||events|||Number
1351900|NCT01773473|Secondary|Change From Baseline in Body Weight at Week 26|LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and had baseline and Week 26 body weight measurements.|||kilogram (kg)||95% Confidence Interval|Least Squares Mean
1351901|NCT01773473|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 FBG measurement.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1352120|NCT01769443|Secondary|Change in Calculated PRA (cPRA) From Wait Listing to Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351902|NCT01773473|Secondary|Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and at least 1 post-baseline HbA1c measurement.|||percentage of participants|||Number
1351903|NCT01773473|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 HbA1c measurements.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1351904|NCT01773291|Secondary|Muscle Power (MP)|"Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement~Flicker of movement only~Movement possible when assisted by gravity or gravity is eliminated~Movement possible against gravity but without imposed resistance~Weak movement possible against gravity~Normal movement against gravity and against imposed resistance~The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The MP was measured before and after treatment during hospitalization.|||units on a scale||Standard Deviation|Mean
1351905|NCT01773291|Primary|Glasgow Coma Scale (GCS)|"Eye response (E)~There are four grades starting with the most severe:~No eye opening~Eye opening in response to pain stimulus.~Eye opening to speech.~Eyes opening spontaneously Verbal response (V)~There are five grades starting with the most severe:~No verbal response~Incomprehensible sounds.~Inappropriate words.~Confused.~Oriented. Motor response (M)~There are six grades:~No motor response~Decerebrate posturing accentuated by pain~Decorticate posturing accentuated by pain~Withdrawal from pain~Localizes to pain~Obeys commands~The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The GCS was measured before and after treatment during hospitalization.|||units on a scale||Standard Deviation|Mean
1351906|NCT01773226|Secondary|Physical Function Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.|||Scores on a WOMAC functionality scale||Standard Deviation|Mean
1351907|NCT01773226|Secondary|Stiffness Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.|||Scores on a WOMAC stiffness scale||Standard Deviation|Mean
1351908|NCT01773226|Secondary|Pain Score|The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.|||Scores on a WOMAC pain scale||Standard Deviation|Mean
1351909|NCT01773226|Secondary|Number of Patients Using Rescue Medication|Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.|Up to 6 months post-injection|The incidence of patients using rescue medication for OA pain.|||Frequency of Patients using Rescue medic|||Number
1351910|NCT01773226|Primary|Number of Adverse Events|Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.|Up to 6 months post-injection|In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis.|||Adverse Events (AEs)|||Number
1351911|NCT01773135|Primary|Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor|measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor|9 weeks||||pg/ml||Inter-Quartile Range|Median
1352121|NCT01769443|Secondary|Time From Wait Listing to Heart Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1351912|NCT01773122|Secondary|Maximum Plasma Level (Cmax) of Dapsone Metabolites|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.|Day 28|All treated subjects with data for this time point|||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
1351913|NCT01773122|Primary|Maximum Plasma Level (Cmax) of Dapsone|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.|Day 28|All treated subjects with data for this time point|||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
1351914|NCT01773070|Secondary|Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection|Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.|Up to 3 years post-treatment|Participants with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
1351915|NCT01773070|Secondary|Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection|Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.|From the end of treatment through 24 weeks post-treatment|Participants who achieved SVR12 and had HCV RNA data available in the SVR24 window. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
1351916|NCT01773070|Secondary|Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection|Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.|From the end of treatment through 12 weeks post-treatment|Participants with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
1351917|NCT01773070|Primary|Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B|The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.|from the last dose of study drug in the previous study up to 3 years post-treatment|GT1a-infected participants who experienced virologic failure after receiving ABT-450, ABT-333 or ABT-267, and had not achieved SVR12 and had post-baseline sequencing data for NS3, NS5A, or NS5B at given time point.|||Participants|||Count of Participants
1351918|NCT01773070|Primary|Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection|Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.|Up to 3 years post-treatment|Participants who achieved SVR12 and had post-SVR12 HCV RNA data available. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
1351919|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Didn't think you needed it because you weren't having risk sex?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351920|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Ran out of study pills?"|48 weeks||||Participants|||Count of Participants
1351921|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Felt depressed/overwhelmed?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351922|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Felt sick or ill?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351923|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Fell asleep/slept through dose time?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351924|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Felt like the study pill was toxic/harmful?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351925|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Had a change in daily routine?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351926|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Did not want others to notice you taking meds?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351927|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Wanted to avoid side effects?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351928|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Had too many study pills to take?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351929|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Simply forgot?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351930|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Were too busy with other things?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351931|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Were away from home?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
1351932|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders|Number of subjects who discontinued receiving text message reminders while they were still on the study agent|48 weeks|Total number of subjects signed up for text message reminders This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.|||Participants|||Count of Participants
1351933|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders|Total number of subjects who signed up for text message reminders|48 weeks|This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.|||Participants|||Count of Participants
1351934|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?"|48 weeks|Participants providing ACASI data for these questions|||Participants|||Count of Participants
1351935|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)"|48 weeks|Enrolled subjects|||copies/ml||Standard Deviation|Mean
1351936|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's BMI (kg/m2), assessed categorically."|48 weeks|Enrolled subjects|||Participants|||Count of Participants
1351937|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino)"|48 weeks|Enrolled subjects|||Participants|||Count of Participants
1351938|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's race (2 categories)"|48 weeks|Enrolled subjects|||Participants|||Count of Participants
1351939|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's race (5 categories)"|48 weeks|Enrolled subjects|||Participants|||Count of Participants
1351940|NCT01772823|Secondary|Explore Potential Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.||48 weeks|Data not collected||||||
1351941|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's age at enrollment."|48 weeks|Enrolled subjects|||years||Standard Deviation|Mean
1351942|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 10 of 10: I felt comfortable participating in this workshop/session."|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351943|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 9 of 10: I would recommend this workshop/session to others."|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351944|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 8 of 10: The workshop/session was enjoyable."|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351945|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 7 of 10: The topic of this workshop/session was relevant to my life"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351946|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 6 of 10: The presenter(s) stimulated my interest in the material"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351947|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 5 of 10: The topic of this workshop/session was interesting"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351948|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 4 of 10: The workshop/session was well organized"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351949|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 3 of 10: I was given an opportunity to participate and discuss information with others"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351950|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 2 of 10: I will be able to apply what I learned from this workshop/session in my life"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351951|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject’s experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 1 of 10: I learned a lot from this workshop/session"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
1351952|NCT01772823|Primary|Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)|"This outcome addresses the objective: Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations."|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.|||fmol/punch||Standard Deviation|Mean
1351953|NCT01772823|Primary|Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)|PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.|||pmol/punch||Standard Deviation|Mean
1351954|NCT01772823|Primary|Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure|"This outcome addresses the objective: Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350– 699 fmol per punch (2–3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily)."|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.|||Participants|||Count of Participants
1351955|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor"|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351956|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit"|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351957|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit"|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351958|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351959|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study|"This outcome addresses the objective Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about taking part in the study."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351960|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day|"This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about taking the pill every day."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351961|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill|"This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about the color of the pill."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351962|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill|"This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about the taste of the pill."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351963|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
1351964|NCT01772823|Primary|Number of Sex Partners|"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:~During the past month, how many male partners have you had sexual contact with (oral or anal)? (Baseline), or Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?” (Week 48)~And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:~Of those you had unprotected sex with, how many did you know were HIV positive?”"|Baseline and 48 weeks|"Participants at Baseline/Week 48 providing a response to this question. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||sexual partners||Standard Deviation|Mean
1351965|NCT01772823|Primary|Number of Participants With Unprotected Sex Acts|"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to male partners in the past month/since the last survey:~Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month? (Baseline), or Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? (Week 48) An event is defined as an answer of greater than 0."|Baseline and 48 weeks|"Participants at Baseline/Week 48 providing a response to this question. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||Participants|||Count of Participants
1351966|NCT01772823|Primary|Total Hip Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total hip."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
1351967|NCT01772823|Primary|Total Body Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total body."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
1351968|NCT01772823|Primary|Femoral Neck Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for femoral neck."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
1351969|NCT01772823|Primary|Lumbar Spine Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for lumbar spine."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
1351970|NCT01772823|Primary|Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48|"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48."|48 weeks|"Enrolled subjects with DXA results for Baseline and Week 48 The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||Participants|||Count of Participants
1351971|NCT01772823|Primary|Number of Participants With Serum Creatinine Event of Grade 1 or Higher|"This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM~Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 – 1.3 x ULN, where ULN is the Upper limit of normal."|48 Weeks|"Participants with visit data through 48 weeks. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||Participants|||Count of Participants
1351972|NCT01772758|Primary|Percentage Flow-Mediated Dilation (FMD)|Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment.|pre-treatment Baseline and 2-3 hours post-treatment|Participants included patients diagnosed with cystic fibrosis and healthy age-matched controls.|||percentage of change in FMD||Standard Deviation|Mean
1351973|NCT01772654|Primary|Intensity of the MRI Signal in the Left Temporal Precentral Zone|Subjects who were already scheduled to have a Magnetic Resonance Imaging (MRI) procedure as part of an evaluation for epilepsy had an additional sequence added during the MRI. The additional MRI sequence was called Arterial Spin Labeling (ASL), and consisted of 4 minutes additional time in the MRI scanner. The ASL sequence did not use any contrast or radiation. The ASL sequence is a blood flow measure, and compared the intensity of the MRI signal in patients with left temporal lobe epilepsy to the intensity of the MRI signal in patients with normal brains. Intensity of MRI signal is measured on the MRI image slices in different anatomic regions as an optical density (dark to bright). It is then referenced to a region of the brain that is considered stable standard as a ratio.|Approximately in the middle of the MRI procedure||||ratio||Standard Deviation|Mean
1351974|NCT01772576|Other Pre-specified|Pacing Impedance|Pacing Impedance at 3 Months Post-Implant|3 Months Post-Implant|Patients with 3 month follow-up|||Ohm||95% Confidence Interval|Mean
1351975|NCT01772576|Other Pre-specified|Sensed Amplitude|Sensed Amplitude at 3 Months Post-Implant|3 Months Post-Implant|Patients having undergone the 3 months follow-up|||mV||95% Confidence Interval|Mean
1351976|NCT01772576|Other Pre-specified|Pacing Threshold|Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant|3-months post-implant|Patients having undergone the 3 months follow-up visit.|||Volt||95% Confidence Interval|Mean
1351980|NCT01772550|Secondary|Catheter Integrity Failure|"Catheter integrity failure generally refers to any portion of the device breaking or malfunctioning so that its proper function is no longer assured. In this study, the most relevant catheter integrity failures to be assessed were fluid leakage, tubing rupture, or tubing separation from the hub.~The number of subjects who experienced injections with a catheter integrity failure during injection is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection."|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
1351981|NCT01772550|Secondary|Catheter Transfixation|The number of subjects who experienced catheter transfixation (the IV penetrating the opposite wall of the vein) is reported. This information was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
1351982|NCT01772550|Secondary|Catheter Dislodgement|The number of subjects who experienced partial or complete dislodgement of the catheter from the subject prior to power injection procedure completion is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|Immediately following power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
1351983|NCT01772550|Secondary|High Pressure Alarm|The number of subjects who experienced injections with activation of the high pressure alarm is reported. Immediately following the power injection, the clinician performing the power injection recorded whether or not the high pressure alarm sounded.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
1351984|NCT01772550|Secondary|Automatic Injection Shutoff|The number of subjects who experienced injections with automatic injection shutoff is reported. Immediately after the power injection, the injection technician recorded whether or not an automatic injection shutoff occurred.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
1351985|NCT01772550|Secondary|Extravasation of Contrast Media|The number of subjects who experienced injections with extravasation of contrast media is reported.|upon contrast injection|One subject randomized to the 18 GA IV was excluded from the per-protocol analysis as minimum flow rate could not be achieved. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
1351986|NCT01772550|Secondary|Catheter Insertion Success|"Insertion is successful when the catheter can be flushed or infused to demonstrate patency, and there is no inadvertent administration of a solution or medication into the tissue surrounding the IV catheter.~The number of participants with successfully inserted catheters after the first or second insertion attempt is reported. The clinician inserting the IV catheter made a clinical judgement as to whether the catheter was successfully placed; the protocol did not define more specific criteria. Catheter insertion success rates were determined from each IV insertion attempted in the Study."|immediately after catheter insertion|All subjects for whom an insertion was attempted are included in the analysis for insertion success. This includes some subjects that did not go on to complete the study.|||participants|||Number
1351987|NCT01772550|Secondary|Maximum Flow Rate|Maximum flow rate guidelines provided in the BD Nexiva Diffusics Instructions for Use were to be followed. The maximum flow rate (milliliters per second, or mL/sec) utilized was recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media. Results are descriptively summarized; no formal acceptance criteria were specified by the protocol.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized flow rate analysis only includes subjects who completed successful contrast delivery; one subject with extravasation upon delivery was discontinued and is not included.|||mL/second||Standard Deviation|Mean
1351988|NCT01772550|Secondary|Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|54 subjects had HU measurements available from complete chest and abdomen CT imaging.|||Hounsfield Units||Standard Deviation|Mean
1352027|NCT01771965|Primary|Change in Treatment Engagement (Number of Participants Entering Treatment)|The investigators will be asking about service utilization since baseline interview. Zero = no mental health treatment and 1 = received mental health treatment.|30 days after baseline|Only 7 of the 10 control participants and 4 of the 9 intervention participants completed follow-up assessments.|||Participants|||Count of Participants
1351989|NCT01772550|Secondary|Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|20 subjects had HU measurements available from thoracic CT imaging.|||Hounsfield Units||Standard Deviation|Mean
1351990|NCT01772550|Secondary|Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|126 subjects had HU measurements available from abdominal CT imaging.|||Hounsfield Units||Standard Deviation|Mean
1351991|NCT01772550|Primary|Acceptable Image Quality|"Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by:~The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and,~the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type.~In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority."|at the time of image assessment|One subject randomized to the 18 GA conventional catheter was excluded from the per-protocol analysis. Due to catheter placement, the required minimum flow rate of 5 mL/sec could not be achieved; contrast was administered at 4.5 mL/sec.|||percentage of participants|||Number
1351992|NCT01772537|Other Pre-specified|Serum Inflammatory Markers|Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured|From the start of the surgery to 24 hours post-op|No data is available for serum inflammatory markers. The study did not have adequate funding to appropriately measure these variables.||||||
1351993|NCT01772537|Secondary|Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)|Delirium was measured using the Confusion Assessment Method and the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) based upon post-operative location of patient. The patients were divided into to two groups, patients that had an open thoracoabdominal aneurysm repair versus patients that had stenting of their aneurysms. Patients that had stenting of their aneurysms were also randomized to receive either Propofol or Isoflurane as for their anesthetic.|Immediately after surgery and at 3 and 12 months post-op|Of the 6 patients that received an open thoracoabdominal aneurysm repair 2 were found to have delirium. Of the 5 subjects that had stenting and received Propofol as their primary anesthetic, 0 were found to have delirium. Of the 3 stenting subjects that received Isoflurane as their primary anesthetic, 1 were found to have delirium.|||participants|||Number
1351994|NCT01772537|Primary|Changes in CSF Levels of Amyloid|Quantitative levels of amyloid will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.|From insertion of spinal drain until removal|The data for changes in CSF levels of amyloid are not available. The study did not have adequate funding to appropriately measure these variables.||||||
1351995|NCT01772537|Primary|Changes in Cerebrospinal Fluid (CSF) Levels of Tau|Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.|From insertion of spinal drain until removal|The data for changes in CSF levels of tau are not available. The study did not have adequate funding to appropriately measure these variables.||||||
1351996|NCT01772368|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|"TEAEs were recorded during each double-blind treatment. In addition, at the end of each treatment, patients continued to use 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.~An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical in"|Day 1 up to Day 35|Safety population|||Participants|||Count of Participants
1351997|NCT01772368|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.|||hours||Full Range|Median
1351998|NCT01772368|Secondary|Maximum Observed Plasma Concentration (Cmax) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.|||pg/mL||Standard Deviation|Mean
1351999|NCT01772368|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.|||pg*hr/mL||Standard Deviation|Mean
1352000|NCT01772368|Secondary|Change From Baseline at 12 Hours Post-Dose in Forced Expiratory Volume in One Second (FEV1) By Treatment|"The secondary efficacy variable was the change from period-specific baseline in FEV1 at 12 hours, calculated as FEV1 measured at 12 hours postdose after subtracting period-specific baseline FEV1 at each treatment period.~The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline."|Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 12 hours|The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.|||mL||Standard Error|Least Squares Mean
1352001|NCT01772368|Primary|Standardized Baseline-Adjusted Area Under the Curve For Forced Expiratory Volume In 1 Second Over 12 Hours Post-dose (FEV1 AUC0-12)|Standardized baseline-adjusted FEV1 AUC0-12 was defined as the area under the curve for baseline-adjusted FEV1 measurements from the predose to 12 hours postdose time points using the trapezoidal rule based on actual (not scheduled) time of measurement and was standardized by dividing the actual time of last non-missing FEV1 measurement. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting period-specific baseline FEV1. The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline.|Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours|The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.|||mL||Standard Error|Least Squares Mean
1352002|NCT01772316|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Minimum score was 0, maximum score was 3. A smaller score indicated improvement.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
1352003|NCT01772316|Secondary|Patient Pain VAS Score at Specified Time Points|This assessment represents the patient’s assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as “no pain” and the extreme right end as “unbearable pain”. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
1352004|NCT01772316|Secondary|Patient Global Visual Analog Score (VAS) at Specified Time Points|This assessment represents the patient’s overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS. The extreme left end of the line should be described as “no disease activity” (symptom free and no arthritis symptoms) and the extreme right end as “maximum disease activity” (maximum arthritis disease activity). Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
1352005|NCT01772316|Secondary|Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation||Randomization of first participant to clinical cutoff date (19MAY2015) (approximately 29 months)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||percentage of participants|||Number
1352006|NCT01772316|Secondary|Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96||Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||percentage of participants|||Number
1352007|NCT01772316|Primary|Change From Baseline in SJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. Change in SJC = SJC at Week 96 - SJC at Baseline. A negative number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||units on a scale||Standard Deviation|Mean
1352008|NCT01772316|Primary|Change From Baseline in Swollen Joint Count (SJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A negative number indicated improvement.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||units on a scale||Standard Deviation|Mean
1352028|NCT01771913|Other Pre-specified|Number of Participants Experiencing Fat Necrosis in the Postoperative Period|Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance. It can emerge as oil cysts or small nodules a little bit painful. In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance. In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence.|up to 3 years||||participants|||Number
1352009|NCT01772316|Primary|Change From Baseline in Total TJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1352010|NCT01772316|Primary|Change From Baseline in Total Tender Joint Count (TJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement. Here, 'n' represents the number of participants with a measure at specified time point.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1352011|NCT01772316|Primary|Change From Baseline in SDAI at Week 96|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, PGA and IGA, and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 96 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1352012|NCT01772316|Primary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, Patient Global Assessment of Disease Activity (PGA) and Investigator Global Assessment of Disease Activity (IGA), and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 48 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. Here, n signifies the number of subjects evaluable at the specified time points.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1352013|NCT01772316|Primary|Change From Baseline in DAS28-ESR at Week 96|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included SJC, TJC, acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status. For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC28]) + (0.28 × √[SJC28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 96 - DAS28-ESR at Baseline.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1352014|NCT01772316|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included swollen joint count (SJC), tender joint count (TJC), acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status (GH). For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC 28]) + (0.28 × √[SJC 28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 48 - DAS28-ESR at Baseline.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1352015|NCT01772316|Primary|Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response||Baseline up to follow-up (Week 104)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||percentage of participants|||Number
1352016|NCT01772316|Primary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a clinical investigation participant that was administered study drug, regardless of causal attribution.|Baseline up to follow-up (Week 104)|All participants receiving study drug were included in the safety analysis set.|||percentage of participants|||Number
1352017|NCT01772147|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.|||puffs||Standard Error|Least Squares Mean
1352069|NCT01770392|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1352018|NCT01772147|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.|||Percentage of days||Standard Deviation|Mean
1352019|NCT01772147|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 6-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
1352020|NCT01772147|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1352021|NCT01772134|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.|||puffs||Standard Error|Least Squares Mean
1352022|NCT01772134|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.|||Percentage of days||Standard Deviation|Mean
1352023|NCT01772134|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 24-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
1352024|NCT01772134|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1352025|NCT01771991|Secondary|Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients|Metrics are measured via analysis of pain and range of motion and Health Related Quality of Life questionnaire.|3 months|||||||
1352026|NCT01771991|Primary|Improvement in Neck Fibrosis|Number of participants with improvement in fibrosis as defined as a one point improvement on the fibrosis scale using the grading scale outlined in CTCAE 4.03, page 46.|3 months|All subjects randomized between August 2012 and May 2013.|||participants|||Number
1352107|NCT01769443|Secondary|Death||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1352029|NCT01771913|Secondary|Immunophenotyping|Immunophenotyping of the fresh stromal vascular fraction of both groups. Immunophenotyping or flow cytometry measures how many cells, in a sample, express a specific surface marker. A surface marker or a group of markers may characterize a specific cell type. The software that accompanies the flow cytometer determines the number of cells (in percentage) that express the tested surface marker.|baseline|we had technical problems in processing 4 tissue samples in each arm.|||percentage of expression for CD90||Standard Deviation|Mean
1352030|NCT01771913|Primary|Volume Maintenance|Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software. Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence. Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume. The result, expressed in percentage, expresses graft volume persistence.|up to 1 year||||percentage of graft volume persistency||Standard Deviation|Mean
1352031|NCT01771666|Secondary|Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes|"The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; GREEN), a fluorescent label; or isosulfan blue (IS-BLUE; BLUE), a visual dye. Results are expressed as:~Any HOT = Those whose samples bound 99tech.~Not HOT = Those whose samples did not bind 99tech.~Not HOT (also no BLUE, no GREEN) = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE.~HOT, BLUE, GREEN = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE.~HOT, no BLUE, no GREEN = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE.~HOT, GREEN only, no BLUE = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE."|1 day||||participants|||Number
1352032|NCT01771666|Primary|Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)|Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.|1 day||||Participants|||Count of Participants
1352033|NCT01771172|Primary|Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.||within the first day||||percentage of success|||Number
1352034|NCT01770860|Secondary|Subjective Assessment of Wound Healing|Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||Participants|||Number
1352035|NCT01770860|Secondary|Subjective Assessment of Itch|Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||percentage of itching||Standard Deviation|Mean
1352036|NCT01770860|Secondary|Subjective Assessment of Pain|Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||percentage of pain||Standard Deviation|Mean
1352037|NCT01770860|Secondary|Maceration|Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||percentage of maceration||Standard Deviation|Mean
1352038|NCT01770860|Secondary|Edema|Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||scores on a scale||Standard Deviation|Mean
1352039|NCT01770860|Secondary|Erythema|Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||scores on a scale||Standard Deviation|Mean
1352040|NCT01770860|Secondary|Forced Rank Score|The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||scores on a scale||Standard Deviation|Mean
1352041|NCT01770860|Primary|Time to Healing (Days)|Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. Forty six subjects were enrolled but one withdrew before randomization.|||days||95% Confidence Interval|Median
1352042|NCT01770743|Primary|Incidence of Immunologically Significant Adverse Events of Special Interest|Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
1352043|NCT01770743|Primary|Incidence of Clinical Laborabory Abnormalities|"Incidence of clinical laboratory abnormalities throughout the study (up to Day 84).~Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality."|From the time of first immunization on Day 0 to Day 84|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
1352044|NCT01770743|Primary|Incidence of Reactogenicity By Severity|"Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity.~Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool):~Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 – 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm.~For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity."|For 7 days following each vaccination on Days 0, 14, 28|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
1352045|NCT01770743|Primary|Incidence of Serious Adverse Events|Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
1352046|NCT01770743|Secondary|TNA Seroconversion Rate|Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84|Up to Day 84|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
1352047|NCT01770743|Secondary|TNA Level at Day 28|Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold|Day 28|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
1352048|NCT01770743|Secondary|TNA Level at Day 42|Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold|Day 42|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
1352049|NCT01770743|Primary|Incidence of Adverse Events|Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84|From the time of the first immunization on Day 0 through Day 84|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
1352050|NCT01770743|Primary|Toxin Neutralizing Antibody (TNA) Level at Day 63|Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold|Day 63|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
1352051|NCT01770691|Primary|Mean Percentage of Pad Weight Gain (PWG) Change|"All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages.~The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula:~% Reduction = 1-(Device/Baseline )*100~Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period."|up to 8 hours of use||||Mean percentage of PWG change||Standard Deviation|Mean
1352108|NCT01769443|Secondary|Incidence of Post-Transplant Lymphoproliferative Disorder (PTLD)||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1352750|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352052|NCT01770652|Primary|Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Fe24 (fraction of dose excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.~Some of the Fe24 values were over 100% which could be explained by variability in urine collection (e.g. incomplete collection of urine into the container) and volume measurement, as well as analytical imprecision."|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter|||% of dose excreted in urine from 0-24 hr||Standard Deviation|Mean
1352053|NCT01770652|Primary|Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide|Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||mg||Standard Deviation|Mean
1352054|NCT01770652|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Standard Deviation|Mean
1352055|NCT01770652|Primary|AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg*h/mL||Standard Deviation|Mean
1352056|NCT01770652|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Full Range|Median
1352057|NCT01770652|Secondary|Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of Ferriprox.|From time of dosing until 72 hours post-dose||||participants|||Number
1352058|NCT01770652|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg/mL||Standard Deviation|Mean
1352059|NCT01770509|Secondary|Time to Complete Closure||4 weeks|Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients||||||
1352060|NCT01770509|Secondary|Incidence of Adverse Events|Number of adverse effects at 4 weeks|4 weeks||||number of adverse effects|||Number
1352061|NCT01770509|Secondary|Incidence of Adverse Events at 4 Weeks|Number of patients with adverse effects at 4 weeks|4 weeks||||Number of patients with adverse events|||Number
1352062|NCT01770509|Secondary|Alleviation of Pain|Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain|4 weeks||||units on a scale||Standard Deviation|Mean
1352063|NCT01770509|Primary|Logarithm of Percentage of Baseline Ulcer Size|Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width|From start of treatment to 4 weeks|Analysis is based on measures from each ulcer, when some participants had more than one ulcer|||Mean of log (percentage of baseline area|Ulcers|Standard Deviation|Mean
1352064|NCT01770483|Secondary|Normalization of Alanine Transferase Test|Liver function test,showing resolution of the inflammation of liver parenchyma|48week|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."|||participants|||Number
1352065|NCT01770483|Primary|Sustained Viral Response,|Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.|48 WEEK|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."|||participants|||Number
1352066|NCT01770431|Secondary|Postoperative Survival Period|Assess Postoperative survival period|Week 94 after took medicine||||weeks||Standard Error|Median
1352067|NCT01770431|Primary|Incidence of Recurrence and Metastasis After Hepatectomy|At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.|Week 94 after took medicine||||Participants|||Count of Participants
1352068|NCT01770392|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352070|NCT01770392|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352071|NCT01770379|Secondary|Percentage of Participants Achieving ACR50|"ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).~The ACR50 response results at week 24 used non-responder imputation."|Week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment|||Percentage of patients|||Number
1352072|NCT01770379|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.|||units on a scale||Standard Error|Least Squares Mean
1352073|NCT01770379|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.|||Units on a scale||Standard Error|Least Squares Mean
1352074|NCT01770379|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|"ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).~The ACR20 response results at week 24 used non-responder imputation."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.|||percentage of participants|||Number
1352075|NCT01770366|Primary|BMI||3 months post surgery||||kg/m2||Standard Deviation|Mean
1352076|NCT01770314|Secondary|Satisfaction With the Program|"We tested and analyzed participants' satisfaction with the program by asking the question: Overall, how satisfied were you with the lessons. They answered on a 4 point Likert scale: 1=Not at all satisfied, 2=Somewhat Satisfied, 3=Satisfied, 4 = Very satisfied. Higher values indicate higher satisfaction."|One-month followup assessment|We only analyzed satisfaction data for experimental participants who had indicated that they disposed of their unused opioid medications (n=17)|||units on a scale||Standard Deviation|Mean
1352077|NCT01770314|Primary|Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications|"Responses are measured on a 4-point Likert scale (1= Not at all confident and 4= Extremely confident). The total Score range:8=least confident, 32=most confident.~How confident do you feel in your ability to do each of the following activities, today?~I can recognize side effects that are related to my opioid medicine.~I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant.~Internal consistency of the items in the pilot measure will be assessed (Cronbach’s alpha).~Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest."|Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention||||units on a scale||Standard Error|Least Squares Mean
1352078|NCT01770145|Secondary|Change From Baseline in Gastric Emptying Time|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic on 2 occasions to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period). Note, to do the second gastroparesis assessment, this sub-group of subjects had an extension for one extra day beyond the designated 7 day APOKYN treatment period (i.e., it will be 8 days) in order to keep the 7 day diary recording outpatient scope of work the same as the rest of the subjects in the study. The second inpatient period was also considered the end-of-study visit for this sub group.|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period)||||||
1352109|NCT01769443|Secondary|Cardiac Dysfunction as Reflected in the Left Ventricular Ejection Fractions < 40% by Echocardiography, Angiogram or Nuclear Testing.||24 and 52 weeks:|No analyses were performed due to slow enrollment and early study closure.||||||
1352079|NCT01770145|Primary|"Change From Baseline in Average Daily Time to on (TTO) by Subject Diary."|"Patients will record daily time to on or TTO following their regularly scheduled first L-Dopa dose in the baseline period for 7 consecutive days. Following initiation on Apokyn therapy, patients will inject Apokyn at their regularly scheduled L-Dopa time (L-Dopa dosing will be delayed by 40 minutes following Apokyn injection) and record time to on or TTO from the injection. Time to on for both periods will be recorded in a standardized subject diary. Daily TTO for the baseline period will be averaged for each subject and compared to the daily TTO for the same subject during the treatment period to assess APOKYN's effect on TTO."|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7||||minutes||Standard Deviation|Mean
1352080|NCT01769612|Primary|Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results|"Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results.~Note: only data where results for all three methods were available were included in the analysis."|within 1 hour after taking samples||||Participants|||Count of Participants
1352081|NCT01769586|Primary|Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)|Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. This scale ranges from 0 to 5, where 0 denotes general anesthesia, in which the patient has no response to painful stimuli, and 5 denotes a level of minimal sedation in which the patient is fully awake.|Approximately 10 minutes or less||||participants|||Number
1352082|NCT01769508|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months||||months||95% Confidence Interval|Median
1352083|NCT01769508|Secondary|Time to Progression (TTP)|Time to progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months||||months||95% Confidence Interval|Median
1352084|NCT01769508|Secondary|Toxicity Profile for Treated Patients|Defined as the frequency of adverse events for patients who received at least one dose of study treatment, and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months|All treated patients|||participants|||Number
1352085|NCT01769508|Secondary|Progression Free Survival (PFS)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||months||95% Confidence Interval|Median
1352086|NCT01769508|Primary|Safety and Optimal Dose of Regimen|An additional primary objective is to evaluate the safety and optimal dose of lapatinib when added to 5-FU, oxaliplatin and radiation therapy.|18 months||||mg QD Lapatinib|||Number
1352087|NCT01769508|Primary|Pathologic Complete Response Rate (pCR Rate)|Defined as the absence of invasive tumor in esophagogastric and lymph node tissue removed at time of surgery, as judged by the local pathologist. An improvement in pCR rate from 30 percent (historical) to 50 percent is the primary efficacy endpoint.|18 months|All patients who underwent surgery|||participants|||Number
1352088|NCT01769456|Secondary|Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not.|Behavioral disinhibition/risk compensation endpoints will be compared.|48 weeks|Data were not collected.||||||
1352089|NCT01769456|Secondary|Evaluation of the Process of Protocol Implementation|"Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated.~NOTE: Data collected to address this outcome were primarily qualitative in nature, and as such are not presented here. For more information on this outcome, refer to:~Gilbert AL, Knopf AS, Fortenberry JD, Hosek SG, Kapogiannis BG, Zimet GD. Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research. J Adolesc Health. 2015 Jul;57(1):113-9."|48 weeks|Quantitative data were not collected for this outcome.||||||
1352090|NCT01769456|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.||48 weeks|Data were not collected.||||||
1352091|NCT01769456|Secondary|Rating of the Reasons for Missing Medications on a 4-point Likert Scale.|"This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.~Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:"|48 weeks|Enrolled subjects with a Week 48 visit; individual rows may have varying Ns due to the number of subjects providing data for each question.|||Participants|||Count of Participants
1352092|NCT01769456|Secondary|Number of Participants Using Text Messaging Reminders|This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders.|Baseline through Week 48|The analysis population for those discontinued is the population (N=22) of those who initially signed up to receive reminders.|||Participants|||Count of Participants
1352093|NCT01769456|Secondary|Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation|Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was session interesting, was it relevant to their life, and did they learn from the session)|48 weeks|Data not collected; only one type of risk reduction intervention was ultimately implemented.||||||
1352110|NCT01769443|Secondary|Number of Subjects on Left Ventricular Assist Devices (LVAD) Compared to Those Not on LVADs||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1352094|NCT01769456|Primary|Estimation of Medication Adherence by Dried Blood Spot (DBS) Results|"This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.~The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch).~The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)"|Week 4, Week 12, Week 24, Week 36, Week 48|Number analyzed in each row varies based on the number of enrolled subjects with DBS data available for each week.|||Participants|||Count of Participants
1352095|NCT01769456|Primary|Acceptability of PrEP Regimen and Study Visits|"This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions."|Week 12|Enrolled subjects with Week 12 data (individual row totals vary based on number of subjects providing responses for each question)|||Participants|||Count of Participants
1352096|NCT01769456|Primary|Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners|"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:~“Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?”~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Week 48|Participants providing data for this question at Week 48.|||male sexual partners||Standard Deviation|Mean
1352097|NCT01769456|Primary|Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex|"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:~Of these males [male partners], how many did you have unprotected oral or anal sex with since the last time you took this survey? An event is defined as an answer of greater than 0.~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Week 48|Participants providing data for this question at Week 48.|||Participants|||Count of Participants
1352098|NCT01769456|Primary|Number of Participants With Decrease in Bone Mineral Density|"The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|48 weeks|Enrolled subjects with DXA results for baseline and Week 48|||Participants|||Count of Participants
1352099|NCT01769456|Primary|Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with DXA data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
1352100|NCT01769456|Primary|Total Body Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in total body BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with DXA data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
1352101|NCT01769456|Primary|Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with DXA data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
1352102|NCT01769456|Primary|Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with dual energy x-ray absorptiometry (DXA) data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
1352103|NCT01769456|Primary|Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study|"This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.~Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48)."|48 weeks||||Participants|||Count of Participants
1352104|NCT01769443|Secondary|Incidence of Rejection Episodes Per Subject and Freedom From Rejection|"Rejection is defined as follows:~Biopsy proven acute rejection (BPAR) of any grade (cellular rejection per 2004 ISHLT [International Society of Heart and Lung Transplantation] grading scale),~BPAR (individual grades),~BPAR (Biopsy Proven Acute Rejection) > 2R~antibody mediated rejection (AMR),~Any treated rejection,~Rejection associated with hemodynamic compromise (HDC)."|24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1352105|NCT01769443|Secondary|Incidence of Hospitalizations||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1352106|NCT01769443|Secondary|Re-transplantation or Re-listed for Transplantation||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
1352122|NCT01769443|Primary|Composite of Incidence of the Following Events in Subjects|"Death,~Removal from the transplant waiting list for any reason except improvement of cardiac function,~Initiation of any mechanical circulatory support device,~Severe infection requiring intravenous antibiotics,~Cerebral vascular accident,~Acute renal failure requiring dialysis."|At transplant, or 90 days post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
1352123|NCT01769391|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)|All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1352124|NCT01769391|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent change from baseline in the sum of target lesions.|Baseline to Progressive Disease or Death (Up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a decrease from baseline in the sum of target lesions.|||percent change in tumor size||Standard Deviation|Mean
1352125|NCT01769391|Secondary|Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).|Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.|||percentage of participants||95% Confidence Interval|Number
1352126|NCT01769391|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Randomization to Progressive Disease or Death (Up to 24 Months)|All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively.|||months||95% Confidence Interval|Median
1352127|NCT01769391|Secondary|Percentage of Participants With Anti Necitumumab Antibodies||Baseline to End of Cycle 6|All participants who received any amount of necitumumab and had post baseline antibody data.|||percentage of participants|||Number
1352128|NCT01769391|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab||Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)|All participants who received at least one dose of necitumumab and had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1352129|NCT01769391|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).|Randomization to Date of Death (Up to 24 Months)|All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively.|||months||95% Confidence Interval|Median
1352130|NCT01769391|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])|The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|Baseline to Disease Progression or Death (Up to 24 Months)|All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.|||percentage of participants||95% Confidence Interval|Number
1352131|NCT01769378|Secondary|Change From Baseline in Amylase|A summary of changes in amylase evaluation from baseline to endpoint.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable amylase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||Units/Liter||Inter-Quartile Range|Median
1352132|NCT01769378|Secondary|Change From Baseline in Lipase|A summary of changes in lipase evaluation from baseline to endpoint.|Baseline, 24 Weeks|All participants who received at least one dose of study drug and had evaluable lipase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||Units/Liter||Inter-Quartile Range|Median
1352133|NCT01769378|Secondary|Dulaglutide Anti-Drug Antibodies (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline up to 4 Weeks Post-Last Dose of Study Drug|ITT population: all randomized participants who received at least one dose of study drug.|||participants|||Number
1352270|NCT01767935|Secondary|Pain Reduction After Cryosurgery, as Measured by the BPI|Paired t-tests and repeated measures analysis adjusting for ECOG status will be used.|Up to 2 weeks post-cryosurgery|Only one patient enrolled, data was not analyzed.||||||
1352134|NCT01769378|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 24 Weeks|ITT population: All randomized participants who received at least one dose of study drug.|||weeks||Standard Error|Mean
1352135|NCT01769378|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 24 Weeks|ITT population: all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1352136|NCT01769378|Secondary|Rate of HE Adjusted Per 30 Days|The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 24 weeks|ITT population: all randomized participants who received at least one dose of study drug.|||number of events/participants/30 days||Standard Deviation|Mean
1352137|NCT01769378|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.|Baseline through 24 Weeks|ITT Population: all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1352138|NCT01769378|Secondary|Change From Baseline in Calcitonin at 24 Weeks||Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline.|||picogram per milliliter (pg/ml)||Inter-Quartile Range|Median
1352139|NCT01769378|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: all randomized participants who received at least one dose of study drug.|||participants|||Number
1352140|NCT01769378|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: All randomized participants who received at least one dose of study drug.|||participants|||Number
1352141|NCT01769378|Secondary|Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks|LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1352142|NCT01769378|Secondary|Change From Baseline in Body Mass Index (BMI) at 24 Weeks|LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline.|||kilograms per/square meter kg/m^2||Standard Error|Least Squares Mean
1352143|NCT01769378|Secondary|Change From Baseline in Body Weight at 24 Weeks|LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
1352144|NCT01769378|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks|LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1352145|NCT01769378|Secondary|Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks|The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.|24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data.|||percentage of participants|||Number
1352146|NCT01769378|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks|Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline.|||percent change of HbA1c||Standard Error|Least Squares Mean
1352147|NCT01769365|Primary|Number of Participants With Complete Eradication of Helicobacter Pylori|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy||||participants|||Number
1352148|NCT01769352|Secondary|Mean Change in Intraocular Pressure Between Week 12 and Week 24|Mean Change in Intraocular Pressure (IOP) between week 12 and week 24|Week 12 and Week 48||||mmHg||Standard Error|Mean
1352149|NCT01769352|Secondary|Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48|Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48|Week 12 and Week 48||||µm||Standard Error|Mean
1352150|NCT01769352|Secondary|Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48|Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.|Week 12 and Week 48||||Letters||Standard Error|Mean
1352151|NCT01769352|Secondary|Mean Change in Intraocular Pressure at Week 12 From Baseline|Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline|Baseline and Week 12||||mmHg||Standard Error|Mean
1352152|NCT01769352|Secondary|Mean Change in Central Subfield Thickness at Week 12 From Baseline|Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline|Baseline and Week 12||||µm||Standard Error|Mean
1352153|NCT01769352|Primary|Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline|Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.|Baseline and Week 12||||letters||Standard Error|Mean
1352154|NCT01769339|Secondary|Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score|Pruritus is assessed by using a 100 millimeter (mm) of VAS score ranges from 0 to 100 mm, where 0 mm=no pruritus and 100 mm=worse pruritus.|1-hour after initial application|Data was not collected as only few participants had pruritus after 1-hour of study drug application.||||||
1352155|NCT01769339|Secondary|Modified Itch Severity Scale (MISS) Score|The MISS is a specific instrument for assessing and quantifying the intensity of pruritus. The MISS score ranges from 0 to 21, where 0=no itching and 21=very severe itching.|Baseline and Day 28|Analysis Population included all the participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants who were evaluable at specified time-point.|||units on a scale||Standard Deviation|Mean
1352156|NCT01769339|Secondary|Percentage of Participants Who Achieved Clinical Cure|Participants were considered as clinically cured if the potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) test was negative for infection.|Baseline up to Day 28|Analysis population included all the participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1352157|NCT01769339|Primary|Mean Time to Itch Relief|Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.|1-hour after initial application|Analysis population included all the participants who received at least 1 dose of study medication.|||minutes||Standard Error|Mean
1352158|NCT01769326|Other Pre-specified|Range of Motion of Shoulder Joint||1 month|||||||
1352159|NCT01769326|Primary|Motor and Strength Outcome Measure Using Fugl-Meyer Score|The primary outcome measure was the change in Upper Extremity FM score on a scale of 0 to 66 at one month post therapy. The higher the scores, the better arm and hand function indicated.|From baseline to 1 month post therapy|Fugl-Meyer score at one month post therapy minus Fugl-Meyer score at baseline on a 66 point scale. Please note that Fugl-Meyer UE motor score is the primary outcome measure for RAE part of the study.|||units on a scale||Standard Deviation|Mean
1352160|NCT01769326|Primary|Motor and Strength Outcome Measure Using Box and Block Test|The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.|From baseline to 1 month post therapy|Number of blocks participants able to pick up and place in a box in 60 seconds at one month follow up minus the number of blocks participants able to pick up and place in a box in 60 seconds at baseline. Please note that box and block test was the primary outcome measure for the Music Glove part of the study.|||blocks||Standard Deviation|Mean
1352161|NCT01769248|Secondary|Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)|As above. Crossover to FNA or FNB occurs after 3 passes without adequate material|1 yr|Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen.|||percentage of participants|||Number
1352162|NCT01769248|Secondary|Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB|The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB|1 year|Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB.|||percentage of participants|||Number
1352163|NCT01769248|Primary|Diagnostic Yield of EUS-FNB and EUS-FNA|The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.|1 year||||percentage of patients|||Number
1352164|NCT01769222|Secondary|Duration of Response (Phase 2 Only)|Data will be summarized using Kaplan-Meier estimates for time to event data.|Up to 5 years|||||||
1352165|NCT01769222|Secondary|Overall Survival (Phase 2 Only)|Data will be summarized using Kaplan-Meier estimates for time to event data.|Up to 5 years|||||||
1352166|NCT01769222|Secondary|Response Rate (Phase 2 Only)|Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|8 weeks||2017-01-31|01/2017||||
1352167|NCT01769222|Secondary|Immune Response (Phase 2 Only)|Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|8 weeks|||||||
1352168|NCT01769222|Secondary|Immune Response (Phase 2 Only)|Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|4 weeks|||||||
1352169|NCT01769222|Primary|Dose-limiting Toxicity|Safety as the percentage of patients experiencing dose-limiting toxicities (DLTs) or serious adverse events (SAEs) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|4 weeks||||percentage of participants|||Number
1352170|NCT01769196|Secondary|Absolute Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Score|"The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.~The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Week 58, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1352171|NCT01769196|Secondary|Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)|"Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130.~The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Weeks 58, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.|||Meters||Standard Error|Least Squares Mean
1352172|NCT01769196|Secondary|Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death||Up to 148 weeks|Participants in the ITT Analysis Set with adjudicated deaths were analyzed.|||Participants|||Count of Participants
1352173|NCT01769196|Secondary|Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations||Up to 148 weeks|Participants in ITT Analysis Set with total hospitalizations were analyzed.|||Participants|||Count of Participants
1352174|NCT01769196|Secondary|Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations||Up to 148 weeks|Participants in the ITT Analysis Set with adjudicated respiratory hospitalizations were analyzed.|||Participants|||Count of Participants
1352175|NCT01769196|Secondary|Relative Change From Baseline in FVC % Predicted|"FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.~Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130~The relative change was calculated as 100% * ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Weeks 54, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.|||Percent change in FVC % predicted||Standard Error|Least Squares Mean
1352176|NCT01769196|Secondary|Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile||Up to 151 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
1352177|NCT01769196|Secondary|Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile||Up to 151 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 50th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
1352178|NCT01769196|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.|Up to 151 weeks|ITT Analysis Set|||months||95% Confidence Interval|Median
1352179|NCT01769196|Primary|PFS Among the Participants With sLOXL2 ≥ 75th Percentile||Up to 148 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
1352180|NCT01769196|Primary|PFS Among the Participants With sLOXL2 ≥ 50th Percentile||Up to 148 weeks|Participants in the ITT Analysis Set with serum LOXL2 (sLOXL2) ≥ 50th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
1352181|NCT01769196|Primary|Progression Free Survival|Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.|Up to 148 weeks|ITT Analysis Set|||months||95% Confidence Interval|Median
1352182|NCT01769105|Secondary|Change in Expressible Meibomian Glands|expressible Meibomian glands are measured with the Meibomian gland evaluator; A higher number of expressible Meibomian glands indicate a lower likelihood Meibomian Gland dysfunction.|after 3 month compared to baseline value||||number of expressible glands||Standard Deviation|Mean
1352183|NCT01769105|Secondary|Change in Lipid Layer Thickness|"lipid layer thickness (LLT) is measured with the Lipiview-interferometer;~High values of LLT indicate a better lubrication of the ocular surface, so an increase in LLT can be regarded in an improvement of ocular surface.~LLT is measured in Interferometric color units (ICUs) whereas 1 ICU reflects about 1 nm lipid layer thickness."|after 3 month compared to baseline value||||nm||Standard Deviation|Mean
1352184|NCT01769105|Secondary|Change in Tear Film Osmolarity|"osmolarity is measured with the tear-lab;~The osmolarity is measured in mOsm/l. A higher osmolarity can be regarded as an objective sign of dry eye disease.~A lower osmolarity after therapy can be regarded as an improvement of ocular surface disease."|after 3 month compared to baseline value||||mOsm/L||Standard Deviation|Mean
1352185|NCT01769105|Secondary|Change of Break-up-time|"break-up-time is measured non-invasive with the Oculus Keratograph 5 M;~The break-up-time is measured in seconds. A low break-up-time suggests a lower lipid layer thickness. A higher break-up-time can be regarded as an improvement of ocular surface lubrication."|after 3 month compared to baseline value||||seconds||Standard Deviation|Mean
1352186|NCT01769105|Primary|Change of Dry Eye Symptoms|"The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI)~Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness).~OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms."|after 3 month compared to baseline value||||units on a scale||Standard Deviation|Mean
1352187|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26||baseline to week 26|completers population|||percentage of participants|||Number
1352188|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26||baseline to week 26|completers population|||percentage of participants|||Number
1352189|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26|Sperm motility was based upon the WHO grading scale: grade A, B, or C.|baseline to week 26|completers population|||percentage of participants|||Number
1352190|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26||baseline to week 26|completers population|||percentage of participants|||Number
1352191|NCT01768676|Primary|Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26|Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.|Baseline to Week 26|Completer population is defined as those who completed the study through week 26 and had semen analysis at both baseline and week 26. This may differ from the definition of completers for the study flow.|||percentage of participants|||Number
1352192|NCT01768572|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.|Up to 211 days|The safety population consisted of all randomized participants who received at least 1 dose or a partial dose of study drug analyzed according to the treatment actually received.|||participants|||Number
1352193|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.|Week 26|mITT population.Participants without post-baseline on-treatment values(HbA1c;body weight),no more than 30 days apart counted as non-responders if at least one of components(HbA1c;body weight) was available,showed non-response or experienced at least one symptomatic hypoglycemia during on-treatment period.Otherwise,they were counted as missing data.|||percentage of participants|||Number
1352194|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response. Otherwise, they were counted as missing data.|||percentage of participants|||Number
1352195|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 26|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|||percentage of participants|||Number
1352271|NCT01767935|Secondary|Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 24 weeks|Only one patient enrolled, data was not analyzed.||||||
1352692|NCT01763918|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set. Least squares (LS) means are from a repeated measures linear effects model; missing values were not imputed.|||percent change||Standard Error|Least Squares Mean
1352196|NCT01768559|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)|"All randomized participants who were exposed to at least one dose of study drug, regardless of the amount of treatment administered.~The 4 participants in the TID group who received Insulin Glulisine QD were analyzed according to the QD dose.The 1 participant in the QD group who received Insulin Glulisine TID was analyzed according to the TID dose"|||percentage of participants|||Number
1352197|NCT01768559|Secondary|Total Insulin Dose at Week 26|"The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.~The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9."|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline total insulin dose assessment during on-treatment period.|||U||Standard Deviation|Mean
1352198|NCT01768559|Secondary|Insulin Glulisine Dose at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glulisine dose assessment during on-treatment period.|||U||Standard Deviation|Mean
1352199|NCT01768559|Secondary|Change in Insulin Glargine Dose From Baseline to Week 26|Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glargine dose assessment during on-treatment period.|||U||Standard Error|Least Squares Mean
1352200|NCT01768559|Secondary|Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Deviation|Mean
1352201|NCT01768559|Secondary|Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Deviation|Mean
1352202|NCT01768559|Secondary|Change in FPG From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1352203|NCT01768559|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 26|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1352204|NCT01768559|Secondary|Percentage of Participants With no Weight Gain at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1352205|NCT01768559|Secondary|Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26|The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1352272|NCT01767935|Secondary|Pain Medication Level, Assessed by Changes in Narcotic Medication Usage|Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose. Paired t-tests and repeated measures analysis adjusting for ECOG status will be used.|Baseline to 24 weeks|Only one patient enrolled, data was not analyzed.||||||
1352751|NCT01763827|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352206|NCT01768559|Primary|Change in Body Weight From Baseline to Week 26|"Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.~Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug."|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||kg||Standard Error|Least Squares Mean
1352207|NCT01768559|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 26|modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1352208|NCT01768325|Secondary|Number of Needle Passes||36 months||||Needle passes||Standard Deviation|Mean
1352209|NCT01768325|Primary|Diagnostic Accuracy.||36 months|One patient was lost to follow up. Final diagnosis was unconfirmed.|||Percentage of participants|||Number
1352210|NCT01768325|Secondary|Overall Specimen Length||36 months||||mm||Standard Deviation|Mean
1352211|NCT01768286|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-Treatment Virologic Failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1352212|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1352213|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1352214|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1352215|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1352216|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set with available data were analyzed. Participants in the LDV/SOF 12 Weeks and LDV/SOF+RBV 12 Weeks groups did not continue treatment past Week 12 and are not included in the analysis.|||percentage of participants|||Number
1352217|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1352218|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1352219|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Full Analysis Set|||percentage of participants|||Number
1352220|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set|||percentage of participants|||Number
1352221|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants|||Number
1352222|NCT01768286|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1352223|NCT01768286|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
1352224|NCT01768286|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
1352225|NCT01768117|Secondary|Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 month after vaccination 3||||participants|||Number
1352226|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined||1 month after vaccination 3||||participants|||Number
1352227|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ||1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3||||participants|||Number
1352228|NCT01768117|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3||||percentage of participants|||Number
1352229|NCT01768117|Primary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||1 month after vaccination 3||||participants|||Number
1352273|NCT01767935|Primary|Changes in Pain Level, as Measured by the BPI|Numerical scores (0-10) from the BPI will be used to measure any change in pain levels. Paired t-tests will be used to assess changes.|Baseline to 24 weeks|Only one patient enrolled, data was not analyzed.||||||
1352230|NCT01768013|Secondary|Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.|"Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28.~Investigator global assessment (IGA) is based on the investigator’s assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Day 28||||participants|||Number
1352231|NCT01768013|Secondary|Efficacy: Percentage Change in m-PASI From Baseline to Day 28|"Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease.~The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified."|Baseline to Day 28||||percentage of change||Standard Deviation|Mean
1352232|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
1352233|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
1352234|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
1352235|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 14||||pg/mL||Standard Deviation|Mean
1352236|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 7||||pg/mL||Standard Deviation|Mean
1352237|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 1||||pg/mL||Standard Deviation|Mean
1352238|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
1352239|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
1352240|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
1352241|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 14||||pg/mL||Standard Deviation|Mean
1352242|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 7||||pg/mL||Standard Deviation|Mean
1352243|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 1||||pg/mL||Standard Deviation|Mean
1352244|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
1352245|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
1352246|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
1352247|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 14||||pg/mL||Standard Deviation|Mean
1352248|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 7||||pg/mL||Standard Deviation|Mean
1352249|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 1||||pg/mL||Standard Deviation|Mean
1352250|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
1352251|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
1352252|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
1352253|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 14||||pg/mL||Standard Deviation|Mean
1352254|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 7||||pg/mL||Standard Deviation|Mean
1352255|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.|Day 1||||pg/mL||Standard Deviation|Mean
1352256|NCT01768000|Secondary|Involvement Evaluation Questionnaire (IES)|The 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
1352257|NCT01768000|Secondary|Satisfaction With Life Scale|8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
1352258|NCT01768000|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
1352259|NCT01768000|Primary|Multnomah Community Ability Scale (MCAS)|The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
1352260|NCT01767987|Secondary|Successful PCI|For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI.|At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
1352261|NCT01767987|Secondary|Death, MI, Revascularization, CHF||1-4 weeks post PCI||||participants|||Number
1352262|NCT01767987|Secondary|Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest||At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
1352263|NCT01767987|Secondary|Left Ventricular End Diastolic Pressure (LVEDP)||During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.|||mmHG|||Number
1352264|NCT01767987|Secondary|Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI||Following completion of PCI through hospital discharge|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
1352265|NCT01767987|Secondary|Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab|Abnormal heart activity|During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
1352266|NCT01767987|Secondary|TIMI Flow Rate (Grade)|"This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.* TIMI Grade [Description] TIMI 0 - no perfusion [no antegrade flow beyond the point of occlusion] TIMI 1 - penetration without perfusion [faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed] TIMI 2 - partial perfusion [delayed or sluggish antegrade flow with complete filling of the distal territory] TIMI 3 - complete perfusion [normal flow with complete filling of the distal territory]~*(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade."|TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.|||units on a scale|||Number
1352267|NCT01767987|Primary|CK-MB|CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|For the single subject completing the PCI intervention, CK-MB was not done because the CK level was below the threshold running the CK-MB test.||||||
1352268|NCT01767987|Primary|Troponin|Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|Of the 4 Ranolazine Group subjects, 1 was withdrawn for pre-procedure study drug non-compliance; 3 had no PCI intervention. Of the 2 Placebo Group subject, 1 had no PCI intervention. The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject undergoing this protocol required test.|||NG/ML|||Number
1352269|NCT01767935|Secondary|Survival|Kaplan-Meier curves will be generated.|Up to 24 weeks post-cryosurgery|Only one patient enrolled, data was not analyzed.||||||
1352274|NCT01767701|Other Pre-specified|Effect of Raltegravir Therapy on Specific Inflammatory Marker of MS Activity.|Measured by Human C-Reactive Protein (HCRP) which is a measure of general inflammation. The higher the value the more inflammatory response is present. The HCRP was measured monthly for six months. The mean value for the baseline three months was compared with the mean value taken for the second (treatment) three months.|Baseline to 6 months|ITT|||ng/mL||Full Range|Mean
1352275|NCT01767701|Other Pre-specified|Mean Number of Adverse Events Per Patient|"This outcome will be assessed by blood and urine sampling; collection of patient reported symptoms and neurological and physical exams.~This measure is the total number of adverse events recorded for each type of event during the study period. The number of participants is 31 which is the number screened and enrolled in the study. Eleven participants did not meet the criterion for baseline i.e. having a gadolinium enhancing lesion on MRI at the baseline visit and therefore did not continue to the baseline observation period. The adverse events for the 11 participants who did not begin the study observation period were recorded during the screening period and added to the 20 participants who were studied during the 6 months of the study. Adverse events are recorded as total number during the study period. Each patient may have had more than one adverse event."|Screening to six months|ITT|||Adverse events||Full Range|Mean
1352276|NCT01767701|Secondary|Percent of Subjects With Scans Free From Enhancing Lesions in Raltegravir Treated Subjects vs. Baseline|This measure is the cumulative percentage of subjects who had scans free from Gd enhancing lesions during the first three months (baseline) compared with the second three months (treatment). These percentages are expressed as a total percentage for the baseline and for the treatment periods.|Baseline to 6 months|ITT|||percentage of subjects|||Number
1352277|NCT01767701|Secondary|Cumulative Number of Gd-T1 Enhancing Lesions|This measure is the number of gadolinium-enhancing T1 lesions as determined by MRI taken on the monthly basis during the six months of the study.|At Baseline and monthly for 6 months|ITT|||Gadolinium enhancing T1 lesions||Full Range|Mean
1352278|NCT01767701|Secondary|Changes in Kurtzke Extended Disability Status Scale (EDSS) Score|"The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The scale has been developed by John F. Kurtzke. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. 0 = Normal 1-1.5 = No disability, but some abnormal neurological signs 2-2.5 = Minimal disability 3-4.5 = Moderate disability, affecting daily activities, but you can still walk. A lower score indicates less disability.~5-8 = More severe disability, impairing your daily activities and requiring assistance with walking 8.5-9.5 = Very severe disability, restricting you to bed 10 = Death EDSS scores were measured monthly over 6 months and the mean of the measurements for the first three months (baseline) was recorded to use calculate the change from baseline compared with the mean of measurements taken monthly during the second three months (treatment)."|Baseline and monthly to month 6|All patients enrolled in clinical trial|||units on a scale||Standard Deviation|Mean
1352279|NCT01767701|Secondary|Change in Score on Multiple Sclerosis Functional Composite (MSFC). This a Composite Score Based on the Measurement of Time in Seconds for the Three Separate Measurements.|Explore preliminary clinical responses in relapsing-remitting multiple sclerosis subjects treated with Raltegravir, compared with baseline as measured by Patient Reported Outcomes (Questionnaires). The MSFC is a composite score consisting of the standardly derived composite score from 9-hole peg test (9HPT), timed walk and PASAT scores. 9HPT is measured as timed speed to complete the task; higher scores indicate less disability. The 25-foot walk is measured as timed speed; higher scores indicate less disability. The Paced Auditory Serial Addition Test (PASAT) The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. It is a timed speed test measured in seconds. In the PASAT a lower score indicates less disability.|Baseline and monthly until month 6.|ITT|||seconds||Standard Deviation|Mean
1352280|NCT01767701|Secondary|The Cumulative Number of New or Enlarging T2 Weighted Lesions on Brain MRI.|"Demonstrate a reduction in the cumulative number of new or enlarging T2 weighted lesions on brain MRI over the period of treatment with Raltegravir compared with baseline.~Within-patient changes in lesion count calculated after-before."|Baseline and monthly for 6 months|ITT|||T2-weighted lesions||Full Range|Mean
1352281|NCT01767701|Primary|The Number of New or Recurrent Gd-enhancing Lesions That Appear on Brain T1-weighted MRI|"Demonstrate in subjects with relapsing remitting multiple sclerosis a reduction in the number of new or recurrent Gd-enhancing lesions that appear on brain T1-weighted MRI over the period of treatment with raltegravir, compared to baseline.~Within patient change in number of lesions was calculated by subtracting the after treatment period (3 months) minus before treatment period (3 months)."|Baseline and at 6 months|ITT|||lesions||Full Range|Mean
1352282|NCT01767688|Secondary|Number of Participants Discontinued From Study Due to AEs|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.|||Participants|||Number
1352283|NCT01767688|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.|||Participants|||Number
1352284|NCT01767688|Secondary|Apparent Terminal Phase Half-life (t½)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||hr||Geometric Coefficient of Variation|Geometric Mean
1352285|NCT01767688|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||hr||Full Range|Median
1352286|NCT01767688|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||nM||95% Confidence Interval|Geometric Mean
1352287|NCT01767688|Secondary|Plasma Concentration at 168 Hours After Dosing (C168h)||168 hours post-dose|All participants that received omarigliptin 25 mg.|||nM||95% Confidence Interval|Geometric Mean
1352693|NCT01763905|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set with available data (no imputation was performed).|||percent change||Standard Error|Least Squares Mean
1352288|NCT01767688|Secondary|Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||µM*hr||95% Confidence Interval|Geometric Mean
1352289|NCT01767688|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||µM*hr||95% Confidence Interval|Geometric Mean
1352290|NCT01767597|Primary|Percentage of Patients Appropriately Seeking Care|"Subjects who are considered required to seek further care are as follows:~those who need HBV vaccination (non-immunized)~those who are infected with hepatitis B virus (infected)~Of these patients, subjects who have achieved appropriate care are considered as follows:~non immunized subjects who have initiated HBV vaccination sequence (vaccinated)~infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)~The percentage of patients appropriately seeking care will be then calculated by the following formula:~((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100"|6 months|Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).|||percentage of participants|||Number
1352291|NCT01767519|Secondary|Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Scores on a Scale||Standard Deviation|Mean
1352292|NCT01767519|Secondary|Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Scores on a Scale||Standard Deviation|Mean
1352293|NCT01767519|Secondary|Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1|Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Nocturia Episodes||Standard Deviation|Mean
1352294|NCT01767519|Secondary|Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1|The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Micturition Episodes||Standard Deviation|Mean
1352295|NCT01767519|Secondary|Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1|A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing ‘greatly improved’ or ‘improved.’|Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Percentage of Patients||95% Confidence Interval|Number
1352296|NCT01767519|Primary|Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Percentage of Patients|||Number
1352297|NCT01767519|Primary|Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Incontinence Episodes||Standard Deviation|Mean
1352298|NCT01767506|Secondary|The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.|"Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center.~If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval."|Baseline only|The trial was conducted at the community level|||community|community|95% Confidence Interval|Mean
1352299|NCT01767506|Secondary|The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below||24 months|The trial was conducted at the community level|||community|community||Count of Units
1352300|NCT01767506|Primary|The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below|The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm|24 months|The trial was conducted at the community level|||community|community||Count of Units
1352449|NCT01766024|Secondary|Кel of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
1352301|NCT01767467|Secondary|Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations|MGI was tabulated per study group and HZ confirmed/non-confirmed status. MGI was defined as the Geometric mean of the within subject ratios of the post-vaccination reciprocal anti-gE concentration to the Month 0 reciprocal anti-gE concentration.|At Month 2|This analysis was performed on the Cohort for correlate of protection, which included subjects from the Total vaccinated cohort receiving 2 vaccine doses and having no confirmed HZ-case before the Month 2 blood sampling, only on the subjects with available results at Month 2.|||Ratio||95% Confidence Interval|Geometric Mean
1352302|NCT01767467|Secondary|Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies|GMCs of anti-gE antibodies were tabulated per study group and HZ confirmed/non-confirmed status and expressed in milli-international units per milliliter (mIU/mL).|At Months 0 and 2|This analysis was performed on the Cohort for correlate of protection, which included subjects from the Total vaccinated cohort receiving 2 vaccine doses and having no confirmed HZ-case before the Month 2 blood sampling.|||mIU/ml||95% Confidence Interval|Geometric Mean
1352303|NCT01767467|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination at Month 0 up to study end at Month 13|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
1352304|NCT01767467|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination|From first vaccination at Month 0 up to study end at Month 13|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
1352305|NCT01767467|Secondary|Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers|"Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as:~For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells).~For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies."|At Months 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Cell Mediated Immunity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.|||Percentage||95% Confidence Interval|Number
1352306|NCT01767467|Secondary|Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers|Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).|At Months 0, 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Cell-Mediated Immunogenicity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.|||CD4 [2+] T-cells/million T-cells||Standard Deviation|Mean
1352307|NCT01767467|Secondary|Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations|Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. Vaccine response was measured in all subjects.|At Months 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 13 visit.|||Percentage||95% Confidence Interval|Number
1352308|NCT01767467|Secondary|Anti-gE Antibody Concentrations|Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). This parameter was assessed in all vaccinated subjects.|At Months 0, 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 13 visit.|||mIU/mL||95% Confidence Interval|Geometric Mean
1352309|NCT01767467|Secondary|Time to Occurrence of Any Confirmed HZ Case|"Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T[year)]). Follow-up period starts Day 1 of vaccination.~Any clinically suspected case of HZ (defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings suggestive of VZV infection in the absence of characteristic HZ or VZV rash.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method."|From Month 0 until study end (Month 13)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Person-year rate||95% Confidence Interval|Number
1352310|NCT01767467|Secondary|Anti-gE Antibody Concentrations|Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).This parameter was assessed in subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||mIU/mL||95% Confidence Interval|Geometric Mean
1352311|NCT01767467|Secondary|Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations|Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||Percentage||95% Confidence Interval|Number
1352312|NCT01767467|Primary|Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMds assessed by the investigator as causally related to the study vaccination|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
1352313|NCT01767467|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
1352314|NCT01767467|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study. It also included any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
1352315|NCT01767467|Primary|Number of Days With Solicited General Symptoms|Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.|Withing the 7-day (Day 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Days||Inter-Quartile Range|Median
1352316|NCT01767467|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary or tympanic route measured temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Participants|||Count of Participants
1352317|NCT01767467|Primary|Number of Days With Solicited Local Symptoms|Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.|Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Days||Inter-Quartile Range|Median
1352318|NCT01767467|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Participants|||Count of Participants
1352319|NCT01767467|Primary|Adjusted Geometric Mean Concentration of Anti-gE Antibodies|The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||mIU/mL||95% Confidence Interval|Geometric Mean
1352320|NCT01767467|Primary|Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations|"Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE [4x97 milli-international units per milliliter (mIU/mL)]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration.~This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia."|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||Percentage||95% Confidence Interval|Number
1352321|NCT01767376|Secondary|Number of Subjects With Serious Adverse Events SAE(s)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study (Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1352322|NCT01767376|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1352323|NCT01767376|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the study (Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1352324|NCT01767376|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Results are presented across doses.|During the 4-day (Days 0-3) period following each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1352325|NCT01767376|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Results are presented across doses, after each vaccination (with Nimenrix, Boostrix, total).|During the 4-day (Days 0-3) following each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1352326|NCT01767376|Secondary|Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations|"Booster response to the pertussis components is defined as:~For initially seronegative subjects, antibody concentration ≥ 4*cut_off (IU/mL) at one month post-vaccination;~For initially seropositive subjects with pre-vaccination antibody concentration < 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 4 fold the pre-vaccination antibody concentration;~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
1352327|NCT01767376|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value|The reference cut-off value of the assay was an antibody concentration ≥ 5.0 ELISA units per milliliter (EL.U/mL)|Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
1352328|NCT01767376|Secondary|Anti-T Antibody Concentrations|The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
1352329|NCT01767376|Secondary|Anti-D Antibody Concentrations|The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
1352330|NCT01767376|Secondary|Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|"rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:~For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): number of subjects with rSBA antibody titers ≥ 1:32 one month after vaccination.~For initially seropositive subjects (pre-vaccination titer ≥ 1:8): number of subjects with rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination."|One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
1352331|NCT01767376|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values|The reference cut-off values of the assay were rSBA-Men antibody concentrations ≥ 1:128 and ≥ 1:8.|Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
1352332|NCT01767376|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|The antibody concentrations were tabulated as adjusted geometric mean concentrations (GMCs) and expressed as international units per millilitre (IU/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group|One month after Boostrix vaccination (i.e. Month 1)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
1352333|NCT01767376|Primary|Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). The reference cut-off value was an antibody concentration ≥ 1 IU/mL. The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group.|One month after Boostrix vaccination (i.e. Month 1)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
1352334|NCT01767376|Primary|Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)|The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group.|One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1352335|NCT01767285|Other Pre-specified|Patient Satisfaction|To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|Participants who completed the 12 month patient satisfaction assessment.|||participants|||Number
1352336|NCT01767285|Other Pre-specified|Pregnancy Rate|To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|all participants who completed the 12 month follow up visit|||participants|||Number
1352337|NCT01767285|Other Pre-specified|Continuation of Breastfeeding|To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|6 months|Participants who completed the 6 month assessment.|||participants|||Number
1352338|NCT01767285|Secondary|Continuation Rate|To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|6 months|Participants who completed the 6 month assessment.|||participants|||Number
1352339|NCT01767285|Secondary|Rate of Intercourse|To identify differences in the rates of intercourse prior to the 6-week postpartum visit.|6 weeks|Participants who completed the 6 week assessment.|||participants|||Number
1352340|NCT01767285|Primary|Continuation Rate|To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|1 year|Participants who completed the 1 year phone visit were included in analysis.|||participants|||Number
1352341|NCT01767155|Secondary|Compare Efficacy Based on Clinical Benefit Rate (CBR).|"Clinical benefit was defined as having stable disease (SD) or better lasting for at least 9 weeks. The CBR was analyzed using the same methods for the ORR analyses. The analysis of CBR (CR+PR+SD) was performed in the ITT (intention-to-treat) population.~CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm.~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died."|3 years||||Participants|||Count of Participants
1352342|NCT01767155|Secondary|Compare Efficacy Based on Progression-free Survival (PFS).|"Progression-free survival (PFS): days between randomization and the date of documented progression or death for any cause that occurred up to the end of the study. For patients whose progression status could not be determined, their PFS data was censored for the last adequate progression assessment date that the patient was confirmed to have no progression.~Response and progression were to be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes were to be used.~During ongoing treatment, patients were to be re-evaluated for response every 3 cycles (i.e. every 9 weeks).~A subsequent scan was obtained no earlier than 4 weeks following the initial documentation of an objective status of either complete response (CR) or partial response (PR)."|During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.|The population analyzed is the mITT. PFS was analyzed in the subset of patients from mITT that have CR, PR or stable disease (SD) as best overall response.|||Participants|||Count of Participants
1352343|NCT01767155|Secondary|Compare Efficacy Based on Objective Response Rate (ORR).|"The ORR was defined as the sum of the Complete Response (CR) and Partial Response (PR).~CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm.~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died."|3 years||||Participants|||Count of Participants
1352344|NCT01767155|Primary|Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin.|"Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact.~The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died.~A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated."|From randomization to death from any cause. During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.||||participants|||Number
1352345|NCT01767116|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.|||percentage of participants|||Number
1352346|NCT01767116|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).|||percentage of participants|||Number
1352347|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of particpants|||Number
1352348|NCT01767116|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.|||percentage of participants|||Number
1352349|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1352350|NCT01767116|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN)."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1352361|NCT01766921|Secondary|Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
1352351|NCT01767103|Primary|Fe% for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative fraction of Ferriprox dose excreted in urine as deferiprone or deferiprone 3-O-glucuronide. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.~Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject’s data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.|||percentage of dose excreted in urine||Standard Deviation|Mean
1352352|NCT01767103|Primary|CumAe for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative amount of deferiprone and deferiprone 3-O-glucuronide excreted in the urine. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.~Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject’s data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.|||mg||Standard Deviation|Mean
1352353|NCT01767103|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||hour||Standard Deviation|Mean
1352354|NCT01767103|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC (area under the curve) from zero to infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||ug*hr/mL||Standard Deviation|Mean
1352355|NCT01767103|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||hour||Full Range|Median
1352356|NCT01767103|Secondary|Safety and Tolerability of Ferriprox in Subjects With or Without Hepatic Impairment.|The number of participants who experienced adverse events following a single dose of Ferriprox, between the time of dosing and the follow-up visit (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests).|Time of dosing until 48 hours post-dose|The Safety Analysis Set consisted of all subjects who received study medication and had at least one safety assessment|||participants|||Number
1352357|NCT01767103|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||ug/mL||Standard Deviation|Mean
1352358|NCT01767064|Primary|Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI)|Using data from electronic health records, we will calculate clinician antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses: acute nasopharyngitis (ICD-9 460.x), acute laryngitis without obstruction (465.8), acute laryngopharyngitis (465.0), acute bronchitis (466.x), acute upper respiratory infections of other multiple sites (465.8), acute upper respiratory infections not otherwise specified (465.9), bronchitis not specified as acute or chronic (490.x), non-streptococcal pharyngitis (462.xx), and influenza with other respiratory manifestations (487.1). To control for temporal trends in antibiotic prescribing and provider-fixed effects, we will fit a logistic mixed effects model that predicts inappropriate antibiotic prescribing as a function of study arm and an indicator for baseline versus intervention period (a difference-in-differences regression).|up to 12 months post intervention|clinicians|||inappropriate prescribing events||95% Confidence Interval|Number
1352359|NCT01766921|Secondary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%."|Day 22, day 43 and day 387|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1352360|NCT01766921|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion.~The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1352450|NCT01766024|Secondary|Т½ of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
1352362|NCT01766921|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine|Day 1 through day 387 after any vaccination|Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data.|||Number of subjects|||Number
1352363|NCT01766921|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data..|||Number of subjects|||Number
1352364|NCT01766921|Primary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.~Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1352365|NCT01766921|Primary|The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%."|Baseline (day 1) and Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
1352366|NCT01766778|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability|This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported.|Month 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication.|||Patients|||Number
1352367|NCT01766778|Secondary|Percentage of Overall Drug Compliance in 12 Months|The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]|Month 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients who had reported dosing compliance were included in this analysis.|||Percentage of overall drug compliance||Standard Deviation|Mean
1352368|NCT01766778|Secondary|Percentage of Patients Achieving Good Glycemic Control|Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.|Month 3, 6, 9, 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. 'n' indicates patients with HbA1c data in that time point.|||Percentage of patients|||Number
1352369|NCT01766778|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)|Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.|Baseline, Month 3, 6, 9 and 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication.|||mmol/L||Standard Error|Least Squares Mean
1352370|NCT01766778|Secondary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)|HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.|Baseline, Month 3, 6, 9 and 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. .|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1352371|NCT01766778|Primary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12|HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c|Baseline, Month 12 (weeK 52)|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients with both baseline and 12 month data were included in this analysis|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1352372|NCT01766713|Primary|Change in Liver Fat as Measured by MRI-PDFF||24 weeks|compared to baseline, end of treatment MRI-PDFF|||percentage of total fat||Standard Deviation|Mean
1352389|NCT01766076|Primary|Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily|Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated|12 weeks|There was no cross-over or carry-over effect (the sequence did not matter), so we present data for 30 patients for their 12 weeks exposure to atorvastatin|||percentage change in activated T-cells||Inter-Quartile Range|Median
1352373|NCT01766466|Primary|Extent of Aggregation Response During Ticagrelor Treatment|"Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.~A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.~Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion||||percentage of platelet reactivity (PR)||Standard Deviation|Mean
1352374|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor|"A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.~Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion||||percentage of platelet reactivity (PR)||Standard Deviation|Mean
1352375|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)|A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)||||percentage of platelet reactivity (PR)||Standard Deviation|Mean
1352376|NCT01766440|Primary|AUC (0-12h) of Calcitriol Plasma Level|AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg*h/mL||Standard Deviation|Mean
1352377|NCT01766440|Primary|AUC (0-9h) of Calcitriol Plasma Level|AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg*h/mL||Standard Deviation|Mean
1352378|NCT01766440|Primary|AUC (0-6h) of Calcitriol Plasma Level|AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg*h/mL||Standard Deviation|Mean
1352379|NCT01766440|Primary|Tmax of Calcitriol Plasma Level|Tmax of calcitriol plasma level at Day 14|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||hour||Standard Deviation|Mean
1352380|NCT01766440|Primary|Cmin of Calcitriol Plasma Level|Cmin of calcitriol plasma level at Day 14|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg/mL||Standard Deviation|Mean
1352381|NCT01766440|Primary|Cmax of Calcitriol Plasma Level|Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg/mL||Standard Deviation|Mean
1352382|NCT01766336|Primary|Number of Participants Experiencing Treatment Emergent Adverse Events|To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.|36 weeks||||participants|||Number
1352383|NCT01766310|Other Pre-specified|Prevalence of Hyperhomocysteinemia|prevalence of hyperhomocysteinemia in Thai obese children|8 weeks||||participants|||Number
1352384|NCT01766310|Secondary|Serum Vitamin B12 Level|correlation between serum vitamin B12 and plasma homocysteine level|8 weeks|||||||
1352385|NCT01766310|Secondary|Serum Folate Level|correlation between serum folate and plasma homocysteine level|8 weeks|||||||
1352386|NCT01766310|Primary|Changes of Homocysteine Level|Mean difference of changes of homocysteine level between 2 treatment groups|8 weeks||||µmol/L||Standard Deviation|Mean
1352387|NCT01766102|Secondary|Assessment of Radiographic and Pathologic Findings|"Assessment of radiographic findings and pathologic findings to determine sensitivity, specificity, positive predictive value, and negative predictive values of intra-operative digital specimen mammography (ISM) and standard specimen mammography for determining margin status.~A true positive (TP) was defined as a positive margin by imaging (ISM or SSM) and pathology~A false positive (FP) was defined as a positive margin by imaging but negative by pathology~A true negative (TN) was defined as a negative margin by both imaging and pathology.~A false negative (FN) was defined as a negative margin by imaging but positive by pathology~The sensitivity [TP/(TP + FN)], specificity [TN/(TN + FP)], positive predictive value [TP/ (TP + FP)], and negative predictive value [TN/(TN + FN)] for identification of positive margins were calculated for ISM and SSM."|2 years|Interpretation of margin status by the surgeon was available for 22 of 36 ISM patients. Interpretation of margin status was also available for 22 of 36 SSM patients.|||Percent|||Number
1352388|NCT01766102|Primary|Comparison of Operative Time Savings|To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.|At the time of the procedure (approximately 1 week after randomization)||||Minutes||Full Range|Median
1352451|NCT01766024|Secondary|Тmax of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
1352390|NCT01766050|Secondary|Mean Change From Baseline in Heart Rate at Study Discharge (Day 46±2 Days)|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and was measured in beats per minute (bpm). Hear rate was taken on Day 46 (day of discharge) during the follow up period. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who received study drug during the treatment period and had measurements at baseline and discharge.|||bpm||Standard Deviation|Mean
1352391|NCT01766050|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Study Discharge (Day 46±2 Days)|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Systolic and Diastolic blood pressures were taken on Day 46 (day of discharge from the study). Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who had received study drug during the treatment period and had measurements at baseline and at discharge.|||mm Hg||Standard Deviation|Mean
1352392|NCT01766050|Secondary|Mean Change From Baseline in Sitting Heart Rate - All Treated Participants|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and the heart rate was measured in beats per minute (bpm). Heart Rates were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received study medication and had baseline and specific day measurement.|||bpm||Standard Deviation|Mean
1352393|NCT01766050|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Pressures were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received any study medication and had a baseline and specific day blood pressure measurement available.|||mm Hg||Standard Deviation|Mean
1352394|NCT01766050|Secondary|Number of Participants With Out-of-Range Electrocardiogram Intervals - All Treated Participants|Participants had 12-Lead electrocardiograms (ECGs) performed at Screening Visit, Day 1 prior to dosing, Day 46 ±2, and at early termination. Definition of out-of-range: PR Interval >210 milliseconds (msec); QRS > 120 msec, QT > 500 msec or > 30 msec change from baseline (Day 1); QT with Fridericia correction (QTcF) > 450 msec or change from baseline of > 30 msec to <= 60 msec or change from baseline > 60 msec.|Day 1 to Day 46 ±2 days or at early termination|All participants who received any study medication and had an ECG performed on Day 1, Day 46 or early termination.|||participants|||Number
1352395|NCT01766050|Secondary|Number of Participants With Marked Hematology and Urinalysis Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46 ±2, and at early termination, after 10 hours fasting. Leukocytes: *10^9 cells per liter (c/L) < 0.85*Pre-Rx if Pre-Rx < LLN or <0.9*LLN if LLN <= Pre-Rx or Pre-Rx is missing. Neutrophils (absolute): *10^12 c/L < 0.85* Pre-Rx if Pre-Rx < 1.5, <1.5 if Pre-Rx >= 1.5, < 1.5 if Pre-Rx missing. Urine blood from dipstick: >=2 if Pre-Rx <1 or was missing or if Pre-Rx >=1. Urinary microscopic white blood cells (WBC) and red blood cells (RBC) >= 2 if Pre-Rx <2 or if Pre-Rx was missing or >=4 if Pre-Rx >=2.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.|||participants|||Number
1352396|NCT01766050|Secondary|Number of Participants With Marked Serum Chemistry Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46, and at early termination, after 10 hours fasting. Upper limits of normal (ULN); Lower limits of normal (LLN); Pre-therapy (Rx); micromoles per liter (µmol/L); millimoles per liter (mmol/L); grams per liter (g/L); Units per liter (U/L); Aspartate Aminotransferase (AST); Blood Urea Nitrogen (BUN) Total Bilirubin: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. AST: >1.25*Pre-Rx if Pre-Rx >ULN or 1.25*ULN if Pre-Rx <= ULN or Pre-Rx is missing. BUN: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. Phosphorus: <0.85*LLN if Pre-RX >= LLN or is missing or if Pre-Rx < LLN. total Protein: <0.9*LLN if Pre-Rx>= LLN or is missing or Pre-Rx > LLN. Creatine Kinase: >1.5*Pre-Rx if Pre-Rx > ULN or is missing or Pre-Rx is <= ULN. Lactate Dehydrogenase: >1.25*ULN if Pre-Rx <= ULN or missing, >1.5*Pre-Rx if Pre-Rx > ULN.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.|||participants|||Number
1352397|NCT01766050|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and AEs Leading to Discontinuation - All Treated Participants|Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA), version 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Events captured from Day 1 (pre-dose) to last day prior to discharge (Day 46 ±2). In the total group, a participant with an AE is only counted once (ie, data reflected in Days 1, 4, 7, and 11 below could be the same participant with an AE on multiple days of the study).|Day 1 to Day of discharge (Day 46±2)|All participants who received any study medication.|||participants|||Number
1352452|NCT01766024|Primary|AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein|Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.|0 to 168 hours post-dose||||(ng/ml)*h||Inter-Quartile Range|Median
1352453|NCT01766024|Primary|Cmax of Interferon Beta-1a|Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose||||pg/ml||Inter-Quartile Range|Median
1352398|NCT01766050|Secondary|Ratio of 1'-Hydroxy-Midazolam (Cmax) to Midazolam (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1'-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352399|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. AUC (0-T) and AUC (INF) were measured as ng*h/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
1352400|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
1352401|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity, were measured as ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
1352402|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
1352403|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): Area under the plasma concentration-time curve from time zero zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
1352424|NCT01766050|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Tmax was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11||||h||Full Range|Median
1352404|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Cmax: Maximum observed plasma concentration was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
1352405|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Losartan With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC (0-T): area under the concentration curve from time 0 to the time of the last quantifiable concentration and AUC (INF) extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
1352406|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Losartan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
1352407|NCT01766050|Primary|Adjusted Geometric Mean Area Under the Concentration Time Curve (AUC) From Zero to Last Concentration (0-T) and AUC Extrapolated to Infinity (INF) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration and AUC (INF): AUC from time zero extrapolated to infinite time were measured in ng*h/mL. Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Midazolam measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
1352408|NCT01766050|Secondary|Ratio of 1’-Hydroxy-Midazolam AUC(0-T) to Midazolam AUC(0-T) and 1’-Hydroxy-Midazolam AUC(INF) to Midazolam AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1’-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352409|NCT01766050|Secondary|Ratio of 5-Dextrorphan (Cmax) to Dextromethorphan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan) to parent (dextromethorphan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352445|NCT01766024|Secondary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Secondary outcome measure for safety assessment|up to Day 43|||||||
1352446|NCT01766024|Secondary|Tmax of Neopterin and MxA Protein|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose|||||||
1352410|NCT01766050|Secondary|Ratio of 5-Dextrorphan AUC(0-T) to Dextromethorphan AUC(0-T) and 5-Dextrorphan AUC(INF) to Dextromethorphan AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan ) to parent (dextromethorphan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352411|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole (Cmax) to Omeprazole (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352412|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole AUC(0-T) to Omeprazole AUC(0-T) and 5-Hydroxyomeprazole AUC(INF) to Omeprazole AUC(INF) , Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-Hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352413|NCT01766050|Secondary|Ratio of E-3174 (Cmax) to Losartan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352414|NCT01766050|Secondary|Ratio of E-3174 AUC(0-T) to Losartan AUC(0-T) and E3174 AUC (INF) to Losartan AUC (INF) Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352415|NCT01766050|Secondary|Ratio of Paraxanthine (Cmax) to Caffeine (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and their metabolites were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352416|NCT01766050|Secondary|Ratio of Paraxanthine AUC(0-T) to Caffeine AUC(0-T) and Paraxanthine AUC (INF) to Caffeine AUC (INF), Corrected for Molecular Weight [MR_AUC(0-T) and MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
1352447|NCT01766024|Secondary|Cmax of Neopterin and MxA Protein Blood Samples Were Taken Before the Injection, Then After 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 Hours.|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose|||||||
1352417|NCT01766050|Secondary|T-HALF of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Plasma half-life (T-HALF) was measured in hours (h). Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||h||Standard Deviation|Mean
1352418|NCT01766050|Secondary|Tmax of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Time of maximum observed plasma concentration (Tmax) was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||h||Full Range|Median
1352419|NCT01766050|Secondary|AUC(INF) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352420|NCT01766050|Secondary|AUC(0-T) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration [AUC(0-T)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352421|NCT01766050|Secondary|Cmax of Inje Cocktail Metabolites (1’-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail component metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail component metabolites were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1352422|NCT01766050|Secondary|Apparent Total Body Clearance (CLT/F) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. CLT/F was measured as liters/hour (L/h)|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11||||L/h||Geometric Coefficient of Variation|Geometric Mean
1352423|NCT01766050|Secondary|Plasma Half-Life (T-HALF) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. T-HALF was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||h||Standard Deviation|Mean
1352448|NCT01766024|Secondary|Cl of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
1352425|NCT01766050|Primary|Adjusted Geometric Mean Maximum Drug Concentration (Cmax) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Cmax measured in nanograms per milliliter (ng/mL). Inje cocktail components (Midazolam) measured using High Performance Liquid Chromatography (HPLC) with Tandem Mass Spectrometry (MS/MS) Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Participants who received any study drug and had at least 1 adequate Pharmacokinetic (PK) profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
1352426|NCT01766037|Other Pre-specified|Safety Outcomes|The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent of Subjects|||Number
1352427|NCT01766037|Secondary|Change in Number of Subjects on Diabetes Medication|Percent change in the number of subjects on Diabetes medication|52 weeks|Subjects being treated for Type II Diabetes|||% Change in Subjects on Medication|||Number
1352428|NCT01766037|Secondary|Change in Number of Subjects on Dyslipidemia Medications|Percent change in the number of subjects on Dyslipidemia medications|52 weeks|Subjects being treated for high cholesterol|||% Change in Subjects on Medication|||Number
1352429|NCT01766037|Secondary|Change in Number of Subjects on Hypertension Medication|Percent change in the number of subjects on Hypertension medication|52 weeks|Subjects being treated for hypertension|||% Change in Subjects on Medication|||Number
1352430|NCT01766037|Secondary|Change in Medications for Type 2 Diabetes|Percent change in the number of medications taken by subjects for Type 2 Diabetes|52 weeks|Subjects being treated for Type 2 Diabetes|||Percent Change in Medications|||Number
1352431|NCT01766037|Secondary|Change in Medications for Dyslipidemia|Percent change in the number of medications taken by subjects for dyslipidemia|52 weeks|Subjects being treated for high cholesterol|||Percent Change in Medications|||Number
1352432|NCT01766037|Secondary|Change in Medication for Hypertension|Percent change in the number of medications taken by subjects for hypertension|52 weeks|Subjects being treated with medications for hypertension|||Percent Change in Medications|||Number
1352433|NCT01766037|Secondary|Procedural Success|vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy|52 weeks|All A-Tube placement attempts|||Percent Procedural Success|||Number
1352434|NCT01766037|Secondary|Mean Change in Hemoglobin A1C|vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.|52 weeks|Subjects with Type 2 Diabetes|||DCCT% change||95% Confidence Interval|Mean
1352435|NCT01766037|Secondary|Mean Change in Score for IWQOL Questionnaire|"v) Impact of Weight on Quality of Life (IWQOL) questionnaire total score~Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients’ IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI’s between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points."|52 weeks|Subjects who completed the Questionnaire at 52 weeks|||score on a scale||95% Confidence Interval|Mean
1352436|NCT01766037|Secondary|Mean Percent Change in Blood Pressure|iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks|||Percent Change||95% Confidence Interval|Mean
1352437|NCT01766037|Secondary|Mean Percent Change in Serum Lipids|iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks|||Percent Change||95% Confidence Interval|Mean
1352438|NCT01766037|Secondary|Percent of Subjects With ≥10% Total Body Weight Loss|ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent of Subjects||95% Confidence Interval|Number
1352439|NCT01766037|Secondary|Mean Percent Total Body Weight Loss|i) Mean percent absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent Total Weight Loss||Standard Deviation|Mean
1352440|NCT01766037|Primary|% of Subjects Who Achieve >25% EWL|The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent of Subjects||95% Confidence Interval|Number
1352441|NCT01766037|Primary|Mean Percent Excess Weight Loss (%EWL)|The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.|52 weeks|Modified Intent To Treat (mITT) population defined as all enrolled subjects|||Percent Excess Weight Loss||Standard Deviation|Mean
1352442|NCT01766024|Secondary|Study Withdrawal Rate Due to AE|Secondary outcome measure for safety assessment|up to Day 43|||||||
1352443|NCT01766024|Secondary|Local Reaction Incidence|Secondary outcome measure for tolerability assessment|up to Day 43|||||||
1352444|NCT01766024|Secondary|AE of Garde 3-4 Incidence|Secondary outcome measure for safety assessment|up to Day 43|||||||
1352454|NCT01766024|Primary|Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)|Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose||||(pg/ml)•h||Inter-Quartile Range|Median
1352455|NCT01765972|Primary|Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit|Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.|8 hours post fit|Analysis population consists of subjects that completed all study visits without a major protocol deviation.|||percentage of change from baseline||Standard Deviation|Mean
1352456|NCT01765803|Secondary|Toxicity|"Toxicity will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.~Any subject who receives treatment on this protocol will be evaluable for toxicity."|Up to 1 month after treatment||||participants|||Number
1352457|NCT01765803|Primary|CD34+ Progenitor Cell Mobilization|To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported|8 hours following treatment||||percentage of total WBC count||Standard Deviation|Mean
1352458|NCT01765764|Secondary|Percentage of Participants With ‘Very Satisfied’ or ‘Mostly Satisfied’ in Eyebrow Satisfaction Scale (ESS) Item #6|"ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported."|Month 7|Intent-to-treat population included all randomized participants.|||percentage of participants|||Number
1352459|NCT01765764|Secondary|Change From Baseline in Eyebrow Darkness as Measured Using DMSIA|Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.|||intensity units||Standard Deviation|Mean
1352460|NCT01765764|Secondary|Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)|Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.|||mm^2||Standard Deviation|Mean
1352461|NCT01765764|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale|The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.|Baseline, Month 7|Intent-to-treat population included all randomized participants.|||percentage of participants|||Number
1352462|NCT01765751|Other Pre-specified|Patient Satisfaction Questionnaire|Participants' satisfaction with study procedures and staff were assessed at Study Visit 5 using standard questions. Participants rated their satisfaction with various elements of the study (e.g., treatments received, clinicians) using a 5 category response from 1 (strongly satisfied) to 5 (strongly dissatisfied) with categories collapsed into satisfied (categories 1 and 2) or not satisfied (categories 3, 4 or 5) for interpretation.|Day 14 (Study Visit 5)||||Participants|||Count of Participants
1352463|NCT01765751|Other Pre-specified|Cervical Muscle Electromyographic (EMG) Activity|"We will describe electromyographic (EMG) activity of superficial neck muscles during delivery of the three manual interventions during visits 3 and 4. EMG measurements are an exploratory outcome variable in this study.~RMS EMG TREATMENT DESCRIPTIONS:~(A) Ratio of Root Mean square (RMS) EMG during Treatment at C5/RMS EMG during maximum voluntary contraction (MVC)~(B) RMS EMG during Treatment at C5/RMS EMG during Prone Resting~(C) RMS EMG during Treatment at Occiput (OCC)/RMS EMG during MVC~(D) RMS EMG during Treatment at OCC/ RMS EMG during Prone Resting~MUSCLES:~LES-Left erector Spinae Muscle~RES-Right Erector Spinae Muscle~LTRPS- Left Trapezius muscle~RTRPS- Right Trapezius Muscle~LSCM- Left Sternocleido Mastoid muscle~RSCM- Right Sternocleido Mastoid Muscle~ACRONYM KEY:~RMS-Root Mean Square Value~MVC-Maximum Voluntary Contraction~C5-Cervical vertebrae contact~OCC-Occipital contact~EMG-Electromyographic activity"|Day 8 (Study Visit 3), Day 11 (Study Visit 4)|The numbers analyzed in the row differ from the overall due to: (1) Data not collected due to technical problems, (2) Patient did not show up for the visit, (3) 3 participants lost to follow up.|||ratio||Standard Deviation|Mean
1352464|NCT01765751|Secondary|Credibility and Expectancy Questionnaire (CEQ)|The CEQ is a quick and easy-to-administer questionnaire for measuring treatment expectancy and rationale credibility of interventions for use in clinical outcome studies. Participants’ perceptions of the study treatments were compared across groups using the CEQ. The CEQ credibility factor relates to how logical or believable a treatment is for the patient, whereas the expectancy factor refers to the patient’s beliefs about improvements that might be achieved from the treatment [61]. CEQ scores for both the credibility and expectancy factors range from 3 to 27, with higher scores indicating greater belief in treatment credibility or expectancy for clinical improvement.|Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5)||||units on a scale (range 3-27)||Standard Deviation|Mean
1352694|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352465|NCT01765751|Secondary|Procedure Believability Questionnaire|"We will ask all participants whether they feel the study procedure would relieve their neck pain using the Procedure Believability Questionnaire. The response choices will be: Strongly believe the procedure will relieve my neck pain; Somewhat believe the procedure will relieve my neck pain; Somewhat believe the procedure will NOT relieve my neck pain; Strongly believe the procedure will NOT relieve my neck pain; and Don't know if the procedure will relieve my neck pain. A baseline (BL) evaluation will be completed based upon treatment description, and compared to assessments following study visit 1 (T1) and study visit 5 (T5) over a 2-week time period."|Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5)||||Participants|||Count of Participants
1352466|NCT01765751|Secondary|Cervical Range of Motion (cROM).|"Cervical ranges of motion are a measure of functional status and can be used to assess dysfunction in the cervical spine. Baseline/visit 1 (BL) cROM is displayed for Flexion-Extension, Lateral Bending, and Rotation. The mean change in cROM from visit 1 to visit 5 (V5 change) is also displayed."|Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5)|"The number analyzed in row differs from overall due to:~Data collection issue due to equipment problems.~Participants did not show up for data collection.~3 Participants were lost to follow up"|||Degrees - Range of Motion||Standard Deviation|Mean
1352467|NCT01765751|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS-43)|"The PROMIS-43 questionnaire will be used to measure general functional health status. PROMIS-43 questions measure physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, and pain interference and intensity.~The table below displays the mean score at baseline. On the T-score metric & interpretation:~A score of 40 is one SD lower than the mean of the reference population (REF POP).~A score of 60 is one SD higher than the mean of the REF POP.~For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average REF POP. This could be a desirable or undesirable outcome, depending upon the concept being measured. For Physical Function and Satisfaction with Social Role, higher scores reflect a better outcome, while for the remaining concepts, higher scores reflect a worse outcome.~PROMIS - Pain Interference adjusted for baseline neck pain VAS."|Change from Baseline to Day 14 (Study Visit 5)||||T-score||Standard Deviation|Mean
1352468|NCT01765751|Secondary|Neck Pain Visual Analogue Scale (VAS)|The VAS has excellent metric properties, is easy to administer and score (0-100mm), and is commonly used in pain research. Our anchors will be no pain (score of 0) to worst pain imaginable (score of 100). We will ask participants to rate their current neck pain at baseline and pre-/post-treatment for all 5 study visits. This measure is adjusted mean neck pain VAS change. A single value was calculated by averaging.|Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5)||||mm||95% Confidence Interval|Mean
1352469|NCT01765751|Secondary|Neck Disability Index (NDI)|The NDI is a 10-item questionnaire modified from the Oswestry Low Back Pain Disability Index. The NDI has been shown to be a reliable and valid measure of disability due to neck pain, and responsive for measuring change. Study Visit 1 and Study Visit 5 Measures occur 2 weeks apart. The NDI scale is measured on a scale of 0-50, with 0 indicating no disability and 50 indicating complete disability. This measure is an adjusted mean NDI change.|Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5)||||units on scale||95% Confidence Interval|Mean
1352470|NCT01765751|Primary|Range of Traction Forces|We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (<20 Newtons [N], 20-50N, >50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome.|Day 1, 4, 8, 11, 14 (Each Study Visit)|*Cervical traction forces measured in Newtons (N) over four treatment visits for each participant. We recorded 23 missing values for traction forces due to 9 missing appointments (18 observations) and 5 instances of technical problems in data collection.|||Newtons (N)|Number of Observations*|Standard Deviation|Mean
1352471|NCT01765673|Secondary|Change in Swallow Initiation Time|Change in swallow initiation time (ms) from swallow reaction time during vibrotactile stimulation minus reaction time with sham (no) stimulation|During one session within 1 hour||||millisseconds||Standard Deviation|Mean
1352472|NCT01765673|Secondary|Percent Change in Swallow Frequency Pulse vs Continuous|Percent Change= [(Number of swallows per minute from continuous stimulation -number of swallows per minute during pulsed stimulation) / number of swallows per minute during pulsed stimulation] X 100|During one session within one hour||||percent change||Standard Deviation|Mean
1352473|NCT01765673|Secondary|Change in Swallow Frequency 6 kPa|The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between increased pressure and no pressure condition|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
1352474|NCT01765673|Secondary|Change in Swallow Frequency 4 kPa|The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
1352475|NCT01765673|Secondary|Change in Swallowing Frequency 2 kPa|The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition|During one session within 1 hour||||Change in Swallow/min||Standard Deviation|Mean
1352476|NCT01765673|Secondary|Change in Discomfort 70 & 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
1352477|NCT01765673|Secondary|Change in Discomfort 150 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
1352478|NCT01765673|Secondary|Change in Discomfort 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
1352479|NCT01765673|Secondary|Change in Discomfort 70 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
1352480|NCT01765673|Secondary|Change in Discomfort Level 30 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
1352481|NCT01765673|Secondary|Change in VAS Urge to Swallow 70 & 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
1352482|NCT01765673|Secondary|Change in VAS Urge to Swallow 150 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
1352483|NCT01765673|Secondary|Change in VAS Urge to Swallow 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
1352484|NCT01765673|Secondary|Change in Urge to Swallow 70 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
1352485|NCT01765673|Secondary|Change in Urge to Swallow After 30 Hz Stimulation|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
1352486|NCT01765673|Primary|Change in Swallowing Frequency 70 & 110 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
1352487|NCT01765673|Primary|Change in Swallow Frequency 150 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
1352488|NCT01765673|Primary|Change in Swallow Frequency 110 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
1352489|NCT01765673|Primary|Change in Swallow Frequency 70 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in Swallows/min||Standard Deviation|Mean
1352490|NCT01765673|Primary|Change in Swallow Frequency 30 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
1352491|NCT01765582|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Randomization up to approximately 3 years|Safety population was defined as all randomized participants who received at least one partial or complete dose of study medication.|||Percentage of participants|||Number
1352492|NCT01765582|Secondary|Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases|The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm. This outcome represents a measure of the rate of conversion from unresectable to resectable disease.|Randomization up to approximately 3 years|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||Proportion of participants||90% Confidence Interval|Number
1352493|NCT01765582|Secondary|Proportion of Participants Who Underwent Liver Metastases Resections|Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm.|Randomization up to approximately 3 years|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||Proportion of participants||90% Confidence Interval|Number
1352494|NCT01765582|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause.|Randomization until death due to any cause (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||months||90% Confidence Interval|Median
1352495|NCT01765582|Secondary|Time to PFS2|Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm.|Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||months||90% Confidence Interval|Median
1352496|NCT01765582|Primary|Progression-Free Survival During First-Line Therapy (PFS1)|PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm.|Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||months||90% Confidence Interval|Median
1352497|NCT01765582|Primary|Percentage of Participants With Overall Response During First-Line Therapy (ORR1)|ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR|Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||Percentage of participants|||Number
1352498|NCT01765569|Primary|Apparent Clearance (CL/F) of Digoxin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.|||liters/hour||Standard Deviation|Mean
1352499|NCT01765569|Primary|Terminal Half-Life (t1/2) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.|||hours||Standard Deviation|Mean
1352500|NCT01765569|Primary|Time to Maximum Plasma Concentration (Tmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||hours||Full Range|Median
1352501|NCT01765569|Primary|Maximum Plasma Concentration (Cmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||ng/mL||Standard Deviation|Mean
1352502|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC168) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||hour*ng/mL||Standard Deviation|Mean
1352503|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||hour*ng/mL||Standard Deviation|Mean
1352504|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.|||hour*ng/mL||Standard Deviation|Mean
1352505|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Digoxin|AUClast = Area under the plasma-concentration time curve from time zero to the last measurable plasma concentration which is presented in hour*nanogram per milliliter (hour*ng/mL). Hour 0 (H0) signified pre-dose sampling.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population included participants for whom PK data were collected.|||hour*ng/mL||Standard Deviation|Mean
1352506|NCT01765543|Other Pre-specified|Percent Extrapolated AUC(0-inf) (AUCpeo) of Vemurafenib|The AUCpeo, that is, percent area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUCpeo = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf). This parameter provides information about what percentage of the theoretical curve AUC(0-inf) is possible to determine experimentally (AUC0-last).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||percent AUC||Geometric Coefficient of Variation|Geometric Mean
1352507|NCT01765543|Other Pre-specified|Area Under the Plasma Concentration Time-curve From Zero to 168 Hours [AUC(0-168)] of Vemurafenib|AUC(0-168) is the AUC from time zero (pre-dose) to 168 hours (time point for last blood sample collection). AUC is a measure of the plasma concentration of a drug over time. AUC(0-168) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352508|NCT01765543|Other Pre-specified|Plasma Apparent Clearance (CL/F) of Vemurafenib|Clearance of a drug is a measure of the rate at which a drug is removed (metabolized or eliminated by normal biological processes) from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
1352509|NCT01765543|Other Pre-specified|Plasma Elimination Half Life (t1/2) of Vemurafenib|Plasma elimination half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||hours||Standard Deviation|Mean
1352510|NCT01765543|Other Pre-specified|Time to Reach Cmax (Tmax) of Vemurafenib|Tmax is the time from vemurafenib administration to reach Cmax for vemurafenib.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||hours||Full Range|Median
1352511|NCT01765543|Primary|Maximum Observed Plasma Concentration (Cmax) of Vemurafenib|Cmax is the maximum observed plasma vemurafenib concentration, presented in microgram per milliliter (mcg/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1352512|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to Extrapolated Infinite Time (AUC[0-inf]) of Vemurafenib|AUC(0-inf) is the AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352513|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measurable Concentration Time Point (AUClast) of Vemurafenib|AUClast is the area under the vemurafenib plasma concentration versus time curve from time zero to the time of last measured concentration of vemurafenib (Tlast). Area under the curve (AUC) is a measure of the plasma concentration of a drug over time. AUClast is presented in micrograms times (*) hour per milliliter (mcg*h/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|The pharmacokinetics (PK) parameter population included all participants who received both scheduled doses of vemurafenib and who provided adequate PK assessments to calculate important PK parameters.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352514|NCT01765530|Secondary|ETT Microbiology|For each patient a quantitative culture will be obtained from the ETT after extubation. Secretions will be retrieved from the ETT after CT scan and quantitative standard cultures will be performed. Microbial molecular diversity analysis and antibacterial resistance patterns will also be studied.|At extubation (An expected average of 5 days)||||Log colony form unit (CFU)/ mL||Standard Error|Mean
1352515|NCT01765530|Primary|Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs|The investigators will measure percentage of occlusion determined by the accumulation of secretion within the lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs. The whole ETT will be analyzed through high-definition CT slices. 100% of occlusion means total occlusion of the lumen of the ETT and 0% means absence of any occlusion.|At extubation (An expected average of 5 days)||||percentage of occlusion||Standard Deviation|Mean
1352516|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(WBC Count)|"laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month||||cells (10^6/µl)||Standard Deviation|Mean
1352517|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)|"laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month||||IU/dL||Standard Deviation|Mean
1352518|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)|"laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month||||mg/dL||Standard Deviation|Mean
1352519|NCT01765465|Primary|the Number of the Participants Have Postoperative RUQ Pain|"Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month.~The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual.~The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results."|postoperative 3-month||||number of participants|||Number
1352695|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352520|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related SAEs|A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.|Dose 1 until 28 days after Dose 2 (Up to Day 118)|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1352521|NCT01765426|Secondary|Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination|A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported.|Day 0 to Day 104|Full analysis set included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid sample for immunogenicity (eg, seroconversion) was received.|||percentage of participants|||Number
1352522|NCT01765426|Secondary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Days 90 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1352523|NCT01765426|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes||Days 0, 28, 90, 118 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1352524|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 118|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1352525|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 28|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1352526|NCT01765426|Primary|Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)|"The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs.~Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention."|118 Days|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1352527|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1352528|NCT01765426|Primary|Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1352529|NCT01765426|Primary|Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1352696|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352530|NCT01765426|Primary|Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant’s worst reported severity grade.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1352531|NCT01765426|Primary|Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
1352532|NCT01765270|Secondary|Need for Antiarrhythmic Therapy||CABG surg to hospital discharge Approximately 5 days||||participants|||Number
1352533|NCT01765270|Secondary|Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support||CABG to hospital discharge (Approximately 5 days)||||participants|||Number
1352534|NCT01765270|Secondary|Number of Participants Who Had an Episode of Hypoglycemia||baseline to end of study (Approximately 35-37 days)||||participants|||Number
1352535|NCT01765270|Secondary|Duration of Inotropic Support||CABG surg until hosp discharge (Approximately 5 days)||||hours||Standard Deviation|Mean
1352536|NCT01765270|Secondary|Number of Major Adverse Cardiac Events (MACE)|Death, myocardial infarction (MI), or New congestive heart failure (CHF)|Baseline to end of study (Approximately 35-37 days)||||Cardiac Events|||Number
1352537|NCT01765270|Secondary|Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)||||ng*hr/mL||Inter-Quartile Range|Median
1352538|NCT01765270|Secondary|High Sensitive Troponin-I (hsTnT) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)||||ng*hr/mL||Inter-Quartile Range|Median
1352539|NCT01765270|Primary|Troponin I (TnI) Area Under the Curve (AUC)||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)||||ng*hr/mL||Inter-Quartile Range|Median
1352540|NCT01765192|Secondary|Change From Baseline in Nighttime Asthma Symptoms|Patients will assess their daily night-time asthma symptoms according to the following scale: 0: No symptoms, slept through the night. 1: Slept well but some complaints in the morning. 2: Woke up once because of asthma (inclusive early awakening). 3: Woke up several times because of asthma (inclusive early awakening). 4: Bad night, awake most of the night because of asthma. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.|||units on a scale||Standard Error|Least Squares Mean
1352541|NCT01765192|Secondary|Change From Baseline in Daytime Asthma Symptoms|Patients will assess their daily day-time asthma symptoms according to the following scale: 0: Very well, no symptoms. 1: One episode of wheezing, cough or breathlessness. 2: More than one episode of wheezing, cough or breathlessness without interfering with normal activities. 3: Wheezing, cough or short of breath most of the day which interfered to some extent with normal activities. 4: Asthma very bad. Unable to carry out daily activities as usual. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.|||units on a scale||Standard Error|Least Squares Mean
1352542|NCT01765192|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF will be measured at home using portable electronic peak flow meter. The participant will record PEF daily in the morning immediately after getting up. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.|||L/min||Standard Error|Least Squares Mean
1352543|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Peak Expiratory Flow (PEF)|PEF is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. PEF will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.|||liters/minute (L/min)||Standard Error|Least Squares Mean
1352697|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352544|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Flow (FEF) 25-75%|FEF is a measure of how much air can be exhaled from the lungs. It is an indicator of obstruction of the smaller airways. FEF25-75% is the mid-flow rate or forced expiratory flow occurring in the middle 50% of the patient's exhaled volume, and will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEF data available for analysis after 4 weeks of treatment.|||liters/second||Standard Error|Least Squares Mean
1352545|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FVC measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FVC data available for analysis after 4 weeks of treatment.|||liters||Standard Error|Least Squares Mean
1352546|NCT01765192|Primary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured using spirometry in accordance with the American Thoracic Society / European Respiratory Society (ATS/ERS) consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEV1 measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEV1 data available for analysis after 4 weeks of treatment.|||liters||Standard Error|Least Squares Mean
1352547|NCT01765179|Secondary|Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|||Participants|||Count of Participants
1352548|NCT01765179|Primary|Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|||Participants|||Count of Participants
1352549|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Data was analysed for the 13 participants who provided CMR data in Training phase 1. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.|||µV||Standard Deviation|Mean
1352550|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from Baseline II to 2 months of Training Phase II|Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
1352551|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis|||µV||Standard Deviation|Mean
1352552|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from Baseline I to 2 months of Training Phase I|Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
1352553|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II|Maximum evoked potentials were measured and compared to baseline measures for major muscle groups.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||percentage of baseline MEP||Standard Error|Mean
1352554|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from Baseline II to 2 months of Training Phase II||||percentage of baseline mep||Standard Error|Mean
1352555|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||percentage of baseline mep||Standard Error|Mean
1352556|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from Baseline I to 2 months of Training Phase I||||Percentage of baseline mep||Standard Error|Mean
1352698|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352557|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine whether training effect was maintained. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.|||µV||Standard Deviation|Mean
1352558|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from Baseline II to 2 months of Training Phase II|Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
1352559|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Data was analysed for the 13 participants who provided CMR data in Training phase 1 in order to dtermine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis|||µV||Standard Deviation|Mean
1352560|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I|Reflexes are elicited in standing by electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG) in µV.|Change from Baseline I to 2 months of Training Phase I|Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
1352561|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).~Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
1352562|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II|The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.|Change from Baseline II to 2 months of Training Phase II|This measure was accidentally omitted for 1 participant at beginning of this phase. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
1352563|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).~Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|This measure was accidentally omitted for 1 participant at the end of this phase. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
1352564|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).~Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
1352565|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
1352566|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from Baseline II to 2 months of Training Phase II||||units on a scale||Standard Deviation|Mean
1352567|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||units on a scale||Standard Deviation|Mean
1352568|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I|"A 20 question survey to measure current level of depressive symptoms. The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
1352569|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||percentage of confidence in balance||Standard Deviation|Mean
1352570|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from Baseline II to 2 months of Training Phase II||||Percentage of confidence in balance||Standard Deviation|Mean
1352571|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||percentage of confidence in balance||Standard Deviation|Mean
1352572|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from Baseline I to 2 months of Training Phase I||||percentage of confidence in balance||Standard Deviation|Mean
1352573|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
1352574|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline II to 2 months of Training Phase II|Measure was added to study protocol midway through study. 1 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
1352575|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Measure was added to study protocol midway through study. 2 out of 17 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
1352699|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352576|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline I to 2 months of Training Phase I|Measure was added to study protocol midway through study. 3 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
1352577|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
1352578|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline II to 2 months of Training Phase II||||units on a scale||Standard Deviation|Mean
1352579|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||units on a scale||Standard Deviation|Mean
1352580|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
1352581|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Measure was added to study protocol midway through study. 2 out of 16 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
1352582|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline II to 2 months of Training Phase II|Measure was added to study protocol midway through study. 3 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
1352583|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Measure was added to study protocol midway through study. 4 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
1352584|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline I to 2 months of Training Phase I|Measure was added to study protocol midway through study. 5 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
1352585|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||m/s||Standard Deviation|Mean
1352586|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline II to 2 months of Training Phase II||||m/s||Standard Deviation|Mean
1352700|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352587|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||m/s||Standard Deviation|Mean
1352588|NCT01765153|Secondary|Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline I to 2 months of Training Phase I||||m/s||Standard Deviation|Mean
1352589|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from the end of Phase II training to 2 months of Rest Period II||||metres||Standard Deviation|Mean
1352590|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from Baseline II to 2 months of Training Phase II||||metres||Standard Deviation|Mean
1352591|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||metres||Standard Deviation|Mean
1352592|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I|Participants walk for as far as possible in 6 min along a 25m hallway.|Change from Baseline I to 2 months of Training Phase I||||metres||Standard Deviation|Mean
1352593|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
1352594|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline II to 2 months of Training Phase II||||units on a scale||Standard Deviation|Mean
1352595|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||units on a scale||Standard Deviation|Mean
1352596|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
1352610|NCT01764841|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)|FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Liter||Standard Deviation|Mean
1352701|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352597|NCT01765153|Primary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)||||units on a scale||Standard Deviation|Mean
1352598|NCT01764997|Secondary|Change From Baseline in DAS28-CRP Score at Week 12||Baseline, Week 12|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1352599|NCT01764997|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24||Week 12 and Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1352600|NCT01764997|Secondary|Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24||Week 12 and Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1352601|NCT01764997|Primary|Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24||Baseline, Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1352602|NCT01764945|Primary|AUC0-tz|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 to the time of the last quantifiable data point.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352603|NCT01764945|Primary|Cmax|Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1352604|NCT01764945|Primary|AUC0-∞|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.|Pharmacokinetic analysis set (PK set) includes all subjects who provided evaluable data for at least 1 evaluable observation for a PK endpoint in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1352605|NCT01764919|Other Pre-specified|Explore the Performance of [124I]FIAU PET-CT Compared to MRI in Detecting Osteomyelitis by Chronic Kidney Disease (CKD) Stage (Stage 1+2, Stage 3, and Stage 4+5).||-2 hours to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.||||||
1352606|NCT01764919|Secondary|Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI|Additional information on the extent and localization of infection will be compared to MRI.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.||||||
1352607|NCT01764919|Secondary|Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection|All PET-CT images will be evaluated centrally and independently by a single radiologist. Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.||||||
1352608|NCT01764919|Secondary|Assess the Safety and Tolerability of [124I]FIAU|Safety will be monitored for all subjects for the duration of their study participation. Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.|30 +/- 2 days||||participants with adverse events|||Number
1352609|NCT01764919|Primary|Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection.|A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.|30 hours||||participants|||Number
1352702|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352611|NCT01764841|Secondary|Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)|The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1352612|NCT01764841|Secondary|Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)|New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of Participants|||Number
1352613|NCT01764841|Secondary|Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)|The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1352614|NCT01764841|Secondary|Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)|Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of Participants|||Number
1352615|NCT01764841|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Number
1352616|NCT01764841|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Number
1352617|NCT01764841|Primary|Time to First Exacerbation Event Within 48 Weeks|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Days||97.5% Confidence Interval|Median
1352618|NCT01764685|Primary|Number of Heavy Drinking Days Per Week by Medication Group|Total number of heavy drinking days (>4 drinks for men; >3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication.|11-week study period|Data was only collected on 3 of the 4 subjects.|||Number of heavy drinking days/week|||Number
1352619|NCT01764633|Secondary|Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.~Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.~Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; the number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352620|NCT01764633|Secondary|Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure|"All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.~HF hospitalization was defined as an event that met all of the following criteria:~Admitted to hospital with a primary diagnosis of HF~In hospital for at least 24 hours~Documented new or worsening symptoms due to HF, including at least 1 of the following:~Dyspnea~Decreased exercise tolerance~Fatigue~Other symptoms of worsened end-organ perfusion or volume overload~Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion~Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; the number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352703|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352621|NCT01764633|Secondary|Time to First Coronary Revascularization|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the “Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction”.~Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; the number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352622|NCT01764633|Secondary|Time to First Stroke|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the “Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction”.~Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.~Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352623|NCT01764633|Secondary|Time to First Myocardial Infarction|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the “Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction”.~The diagnosis of myocardial infarction required the combination of:~Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and~Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging.~Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352624|NCT01764633|Secondary|Time to All Cause Death|Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352625|NCT01764633|Secondary|Time to Cardiovascular Death|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the “Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction”.~Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.~Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352626|NCT01764633|Secondary|Time to Cardiovascular Death, Myocardial Infarction, or Stroke|All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the “Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction”. Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352638|NCT01764386|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mm Hg||Standard Error|Least Squares Mean
1352627|NCT01764633|Primary|Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization|"All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the “Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction”.~Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
1352628|NCT01764607|Secondary|Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma|Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.|At baseline and time of surgical removal (5 weeks).||||percentage of baseline size|||Number
1352629|NCT01764607|Primary|Measure of Squamous Cell Skin Carcinoma in Patients|Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.|Baseline, time of surgical removal (5 weeks) and 1 year.||||mm|||Number
1352630|NCT01764386|Secondary|Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26|Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
1352631|NCT01764386|Secondary|Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26|Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
1352632|NCT01764386|Secondary|Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26|The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
1352633|NCT01764386|Secondary|Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26|HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose * Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
1352634|NCT01764386|Secondary|Change Fasting Insulin From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||uIU/mL||Standard Error|Least Squares Mean
1352635|NCT01764386|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
1352636|NCT01764386|Secondary|Change in Heart Rate From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||bpm||Standard Error|Least Squares Mean
1352637|NCT01764386|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mm Hg||Standard Error|Least Squares Mean
1352639|NCT01764386|Secondary|Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
1352640|NCT01764386|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
1352641|NCT01764386|Secondary|Change in Fasting Triglycerides From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
1352642|NCT01764386|Secondary|Change in Waist Circumference From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||cm||Standard Error|Least Squares Mean
1352643|NCT01764386|Secondary|Absolute Change in Body Weight From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||kg||Standard Error|Least Squares Mean
1352644|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percentage of participants|||Number
1352645|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percentage of participants|||Number
1352646|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percentage of participants|||Number
1352647|NCT01764386|Primary|Percent Change in Body Weight From Baseline (Day 1) to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percent change in body weight||Standard Error|Least Squares Mean
1352648|NCT01764022|Secondary|T1/2|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||hours||Inter-Quartile Range|Median
1352649|NCT01764022|Secondary|Tmax|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||hours||Inter-Quartile Range|Median
1352650|NCT01764022|Secondary|Cmax|secondary outcome measure for PK substudy|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||µg/ml||Inter-Quartile Range|Median
1352651|NCT01764022|Secondary|Occurrence of Anti-trastuzumab Antibodies|Secondary outcome measure for immunogenicity assessment|Day 1 (before the drug administration), Day 15, 64 and 127|Patients who received at least one injection of study drug.|||participants|||Number
1352652|NCT01764022|Secondary|Treatment Discontinuation Rate Due to AE|secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.|||participants|||Number
1352653|NCT01764022|Secondary|Number of Patients in Whom Chemotherapy Cycles Had Been Postponed Due to Adverse Events (AE)|secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.|||participants|||Number
1352654|NCT01764022|Secondary|Progression Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||percentage of patients||95% Confidence Interval|Mean
1352689|NCT01763918|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352690|NCT01763918|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352655|NCT01764022|Secondary|Stabilization Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||percentage of patients||95% Confidence Interval|Mean
1352656|NCT01764022|Secondary|Partial Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||percentage of patients||95% Confidence Interval|Mean
1352657|NCT01764022|Secondary|Complete Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||percentage of patients||95% Confidence Interval|Mean
1352658|NCT01764022|Primary|Area Under the Curve After the First Test Drug Administration|primary outcome measure for pharmacokinetics (PK) substudy|up to Day 22, after the first trastuzumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||(µg/ml)*hour||Inter-Quartile Range|Median
1352659|NCT01764022|Primary|Overall Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||percentage of patients||95% Confidence Interval|Number
1352660|NCT01763996|Secondary|Exercise Duration|Exercise duration is the exercise time in seconds during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||seconds||95% Confidence Interval|Least Squares Mean
1352661|NCT01763996|Secondary|Time to Onset of Angina During Exercise Treadmill Test at the End of the Administration of Febuxostat and Placebo|Time in seconds to ischemic chest pain/ angina during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic chest pain.|||seconds||Standard Deviation|Mean
1352662|NCT01763996|Secondary|Percentage of Participants Stopping Exercise Treadmill Test Due to Angina at the End of the Administration of Febuxostat and Placebo|An exercise treadmill test (modified Bruce protocol) was performed. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||percentage of participants|||Number
1352663|NCT01763996|Secondary|Change in Maximum ST-segment Depression During Exercise Treadmill Test|Continuous ECG was performed during an exercise treadmill test (modified Bruce protocol) to assess the maximum ST-segment depression after 6 weeks of febuxostat or placebo treatment in participants with a normal ST segment at randomization. A negative change from Baseline indicates improvement. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ST segment change.|||mm||Standard Deviation|Mean
1352664|NCT01763996|Secondary|Change in Time to Onset of ≥1 mm ST-Segment Depression During Exercise Treadmill Test (ETT)|Time in seconds to ischemic ECG changes during ETT. Continuous electrocardiography (ECG) was performed during an exercise treadmill test (modified Bruce protocol) to assess the onset of ST-segment depression after administration of febuxostat or placebo for 6 weeks in participants with a normal ST segment at randomization. . Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic ECG changes.|||seconds||Standard Deviation|Mean
1352665|NCT01763996|Secondary|Change in Coronary Flow Velocity Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.|||cm/second||95% Confidence Interval|Least Squares Mean
1352666|NCT01763996|Secondary|Change in Coronary Artery Cross Sectional Area Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery cross sectional area was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.|||mm^2||95% Confidence Interval|Least Squares Mean
1352667|NCT01763996|Secondary|Change in Coronary Artery Flow Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.|||mL/min||95% Confidence Interval|Least Squares Mean
1352668|NCT01763996|Secondary|Change in Coronary Flow Velocity From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||cm/second||95% Confidence Interval|Least Squares Mean
1352669|NCT01763996|Secondary|Change in Coronary Artery Cross-Sectional Area From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery cross-sectional area was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||mm^2||95% Confidence Interval|Least Squares Mean
1352670|NCT01763996|Primary|Change in Coronary Artery Flow From Rest to Isometric Handgrip (IHG) Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured using magnetic resonance imaging (MRI) at rest and during sustained isometric (static) handgrip exercises. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||mL/min||95% Confidence Interval|Least Squares Mean
1352671|NCT01763918|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352672|NCT01763918|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352673|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352674|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352675|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352676|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352677|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352678|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352679|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352680|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352681|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352682|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352683|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352684|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352685|NCT01763918|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352686|NCT01763918|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352687|NCT01763918|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352688|NCT01763918|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352705|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352706|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352707|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full anlaysis set|||percent change||Standard Error|Least Squares Mean
1352708|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352709|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352710|NCT01763905|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352711|NCT01763905|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352712|NCT01763905|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352713|NCT01763905|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352714|NCT01763905|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set (all randomized participants who received at least 1 dose of investigational product (subcutaneously or orally)) with available data (no imputation was performed).|||percent change||Standard Error|Least Squares Mean
1352715|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352716|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352717|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352718|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352719|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352720|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352721|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352722|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352723|NCT01763866|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352724|NCT01763866|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352725|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352726|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352727|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352728|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352729|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352730|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352731|NCT01763866|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352732|NCT01763866|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352733|NCT01763866|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352734|NCT01763866|Secondary|Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352735|NCT01763866|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352736|NCT01763866|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352737|NCT01763827|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Inter-Quartile Range|Median
1352738|NCT01763827|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
1352752|NCT01763827|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352753|NCT01763827|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352754|NCT01763827|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1352755|NCT01763827|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352756|NCT01763827|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1352757|NCT01763827|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352758|NCT01763827|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
1352759|NCT01763645|Secondary|Occurrence of Anti-bevacizumab Antibodies|Secondary outcome measure for immunogenicity assessment|Day 1 (before the drug administration), Day 15, 64 and 127||||percentage of patients|||Number
1352760|NCT01763645|Secondary|Progression Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
1352761|NCT01763645|Secondary|Stabilization Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
1352762|NCT01763645|Secondary|Partial Response Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
1352763|NCT01763645|Secondary|Complete Response Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
1352764|NCT01763645|Primary|Area Under the Curve After the First Test Drug Administration|primary outcome measure for pharmacokinetics (PK) substudy|up to Day 22, after the first bevacizumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after injection had missed <= 1 blood sample collection to analyze pharmacokinetics.|||(ng/ml)*hour||Inter-Quartile Range|Median
1352765|NCT01763645|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Day 127|The efficacy analysis included only those patients who received at least one dose of BCD-021 or Avastin®, and in whom it was possible to assess the response to therapy.|||percentage of participans||95% Confidence Interval|Number
1352766|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert|Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours||||percentage of all alerts|||Number
1352767|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert|Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours||||percentage of all alerts|||Number
1352768|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|72 hours||||percentage of total events|||Number
1352769|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|up to 72 hours||||percentage of total events|||Number
1352770|NCT01763567|Primary|Device Performance: Accuracy of HGMS|"Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values].~The portable i-STAT handheld makes patient-side testing easy:~Requires no special sample preparation or user calibration; maintenance is minimal~Weighs 18 ounces, making it portable~Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:~The system prompts users step by step through the testing process~Operator and patient information can be entered via barcode scanner~Operator lockout prevents unauthorized users from performing or viewing test results~Test results are uploaded automatically when the i-STAT handheld is placed in a downloader"|up to 72 hours|To assess safety and device performance for the Hospital Glucose Managment system|||percent difference||Standard Deviation|Mean
1352810|NCT01762761|Secondary|Pharmacodynamic Parameter-Maturation Rate of Platelet Precursors (KOUT)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KOUT was fixed to 0.0253 /hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population|||1/ hr|||Number
1352915|NCT01760993|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352771|NCT01763047|Primary|CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8-12 days post wear|The analysis consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.|||units on a scale||Standard Deviation|Mean
1352772|NCT01763047|Primary|Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher|Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.|||Percentage of Subject Eyes|Subject Eyes||Number
1352773|NCT01763047|Primary|Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher|The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.|||Percentage of Subject Eyes|Subject Eyes||Number
1352774|NCT01763047|Primary|Percentage of Eyes With Corneal Staining Grade 3 or Higher|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject’s inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.The analysis was conducted on subject eyes for each lens and strata.|||Percentage of Subject Eyes|Subject Eyes||Number
1352775|NCT01763047|Primary|Binocular Near Visual Acuity (logMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.|||LogMAR||Standard Deviation|Mean
1352776|NCT01763047|Primary|Binocular Distance Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.|||LogMAR||Standard Deviation|Mean
1352777|NCT01762982|Secondary|Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Number of participants|||Number
1352778|NCT01762982|Secondary|Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Number of participants|||Number
1352779|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Percentage of participants|||Number
1352916|NCT01760993|Secondary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352780|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Percentage of participants|||Number
1352781|NCT01762982|Secondary|Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Number of participants|||Number
1352782|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|Intention to Treat (ITT) population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment.|||Percentage of participants|||Number
1352783|NCT01762943|Secondary|Change in Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Score|"The IDAS Dysphoria Scale consists of 10 items and uses a 5-point Likert-type scale, ranging from 1 to 5 with 1 indicating not at all and 5 indicating extremely. As such, the range of possible scores is 10 to 50. The Dysphoria scale includes items assessing feelings of depression, inadequacy, psychomotor agitation, guilt, discouragement, anhedonia, poor concentration, difficulty with decision-making, psychomotor retardation, and worry. Higher scores indicate greater dysphoria."|Assessed at baseline and post-treatment|Of the 36 women who enrolled in the study, 6 (4 PPD, 2 controls) were withdrawn prior to the second fMRI session. For the purpose of this group x time analysis, their data have been excluded. All 30 subjects who completed the protocol were included in this analysis.|||units on a scale||Standard Deviation|Mean
1352784|NCT01762943|Primary|Blood-oxygen-level-dependent (BOLD) Response During Functional Magnetic Resonance Imaging (fMRI) z Statistic|The primary outcome measure was functional magnetic resonance imaging (fMRI) data collected during a Monetary Incentive Delay (MID) Task. The BOLD response was examined within the nucleus accumbens, a brain region that responds to monetary rewards. The z statistic represents the maximum contrast between win versus non-win outcomes during the MID task in the nucleus accumbens, averaged across the participants in each group. The mean BOLD response ranged from z=1.7 to 2.3; higher z scores indicate greater activation of the nucleus accumbens during reward. Individual z scores were generated using the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library (FSL), which is a library of brain imaging analysis tools for fMRI.|baseline and hormone withdrawal|Of the 36 women who enrolled in the study, 6 were withdrawn prior to the second fMRI session. For the purpose of this group x time analysis, their data have been excluded. In addition, one participant had significant motion artifact (>4mm) during one run of the MID, and as such, her data were excluded from the analyses.|||z score||Standard Deviation|Mean
1352785|NCT01762904|Secondary|Detect Presence of Allergy or Skin Reaction by the Antiseptic Application|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Presence of allergy or any skin reaction at 24 hours after the antiseptic application."|24 hours||||participants||Inter-Quartile Range|Median
1352786|NCT01762904|Primary|Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab|"135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hrs||||(CFU/cm2)||Inter-Quartile Range|Median
1352787|NCT01762904|Primary|Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours||||(CFU/cm2)||Inter-Quartile Range|Median
1352788|NCT01762904|Primary|Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically|"135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours||||(CFU/cm2)||Inter-Quartile Range|Median
1352789|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Physician|Physician evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|24 weeks|mITT population|||Participants|||Number
1352790|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Participants|Participants evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population|||Participants|||Number
1352791|NCT01762800|Secondary|Percentage of Participants Who Dropped Out|The percentage of participants who were withdrawn from the study.|24 weeks|All Subjects population: all participants who were enrolled into the study and whose data obtained at screening (visit1) was not missing and demography data was available.|||Percentage of participants|||Number
1352792|NCT01762800|Secondary|Percentage of Participants Who Required Additional Treatment to TRIPLE Therapy|The percentage of participants who required additional treatment to TRIPLE therapy is defined as number of participants who took additional medicine or therapy in TRIPLE therapy divided by number of participants who switch to TRIPLE therapy multiplied by 100.|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
1352793|NCT01762800|Secondary|Percentage of Participants Who Stepped Down From TRIPLE Therapy to Initial Randomized Treatment|The percentage of participants who stepped down from TRIPLE therapy to initial randomized treatment was calculated as number of participants who step-down from TRIPLE therapy divided by number of participants who switch to TRIPLE therapy and then multiplied by 100.|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
1352794|NCT01762800|Secondary|Percentage of Participants Who Used Relief Medication (Salbutamol)|Each evening participants recorded the number of occasions in the last 24 hours when they used their salbutamol for symptomatic relief of COPD symptoms. The percentage of participants who used relief medication in the study are presented.|24 weeks|mITT population|||Percentage of participants|||Number
1352795|NCT01762800|Secondary|Change From Baseline in FEV1|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. Baseline was a value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. FEV1 was assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Baseline (Visit 2) and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Liters||Standard Deviation|Mean
1352796|NCT01762800|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. At Screening (Visit 1) spirometric assessments were conducted before (Visit 1A) and 30 to 60 minutes after a bronchodilator challenge (400 µg of salbutamol) (Visit 1B). FEV1 during each visit are presented. FEV1 was assessed at Visit 1A (Screening), Visit 1B (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Liters||Standard Deviation|Mean
1352797|NCT01762800|Secondary|Change From Baseline in CAT Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Baseline was the value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. Scores were assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1352798|NCT01762800|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Scores were assessed at Visit 1 (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1352799|NCT01762800|Secondary|Comparison of Number of Exacerbations Between Two Detection Methods: EXACT and Physician Diagnosis|The comparison of number of exacerbation between two detection methods EXACT and physician diagnosis: number of exacerbations detected by EXACT and number of exacerbations judged by physician.|24 weeks|mITT population|||Number of exacerbations||Standard Deviation|Mean
1352917|NCT01760993|Primary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352800|NCT01762800|Secondary|E-RS Subscale Score|The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. The E-RS subscale scores for respiratory symptoms (RS)-breathlessness (RS-BRL), RS-cough and sputum (RS-CSP), and RS-chest symptoms (RS-CSY) are presented. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score. Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. RS total scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1352801|NCT01762800|Secondary|EXACT Respiratory Symptoms (E-RS) Total Score|"The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. Scores range from 0-100, high value in score indicate worse outcome."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1352802|NCT01762800|Secondary|EXACT Total Score.|"EXACT is a 14-item patient questionnaire used as a measure of respiratory symptoms (reported as units on a 0 [best health status] to 100 [worst possible status] scale). Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1352803|NCT01762800|Secondary|Time to First Exacerbation by EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)|The EXAcerbations of Chronic pulmonary disease Tool (EXACT) is a 14-item patient-reported outcome (PRO) daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Reported as units on a 0 [best health status] to 100 [worst possible status] scale). The day of detection of first exacerbation in any participant in each arm by EXACT.|24 weeks||||Days|||Number
1352804|NCT01762800|Secondary|Time to First Exacerbation by Physician's Diagnosis|The day of detection of first exacerbation in any participant in each arm as diagnosed by physician. Exacerbation is defined primarily by physician’s judgment. Date of randomisation will be start point and timing of exacerbation (first exacerbation if there are more than one) will be event. For subjects without exacerbation, last day of study or follow up period is regarded as censor.|24 weeks|mITT population|||Days|||Number
1352805|NCT01762800|Secondary|Time to First Switching to TRIPLE Therapy|The day of first switch to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) for the first switching participant in each arm.|24 weeks|mITT population|||Days|||Number
1352806|NCT01762800|Secondary|Continuation Percentage of Participants Managed by Randomized Treatment Plus TRIPLE Therapy|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) was not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. Continuation TRIPLE proportion is defined as [(number of subjects who switched to TRIPLE) - (number of subjects who stepped down)/ number of evaluable population]*100. Randomised treatment continuation proportion is calculated by a formula: (100 - switch proportion).|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
1352807|NCT01762800|Secondary|Percentage of Participants Managed by TRIPLE Therapy|Percentage of participants managed by TRIPLE therapy was calculated as [(number of participants who switched to TRIPLE therapy) - (number of participants who stepped down)/ number of evaluable population]*100|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
1352808|NCT01762800|Secondary|Percentage of Participants Who Switched to TRIPLE Therapy|Switched to TRIPLE therapy is defined as: 1. Date of switch: when SAL/FLU or TIO was administered additionally to randomised treatment. 2. Date of randomisation was a start point and timing of switching (first switch if there are more than once) to TRIPLE was event. For participants without switching, last day of study or follow up period was regarded as censored. Percentage of participants who switched to TRIPLE therapy was calculated as: number of participants who switched to TRIPLE therapy divided by number of evaluable population and then multiplied by 100.|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
1352809|NCT01762800|Primary|Percentage of Participants Who Were Able to Remain on the Randomized Treatment|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) is not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. The percentage of participants who were able to remain on the randomized treatment was calculated by the following formula: 100 minus percentage of participants who switched over to TRIPLE therapy.|24 weeks|Modified Intent-to-Treat (mITT) population: randomized participants who received at least a single dose of the investigational product.|||Percentage of participants||95% Confidence Interval|Number
1352852|NCT01762345|Primary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||grams/usage period||Inter-Quartile Range|Median
1352811|NCT01762761|Secondary|Pharmacodynamic Parameter- Production Rate of Platelet Precursors (KIN)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KIN was fixed to 1.43x10^9/L.hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population|||1 x 10^9/L.hr|||Number
1352812|NCT01762761|Secondary|Pharmacodynamic Parameter-Linear Proportionality Constant of Drug Effect (SLOP): the Proportional Increase of Platelet Production Rate With Each 1-μg/mL Increase in Eltrombopag Plasma Concentration|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population|||Milliliter/microgram||95% Confidence Interval|Geometric Mean
1352813|NCT01762761|Secondary|Percentage of Participants Estimated as Responders to Eltrombopag by the Pharmacokinetic/ Pharmacodynamic Model|Responders are participants whose SLOP estimates are larger than zero. The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population: all participants with evaluable dosing, actual sampling time, and platelet count data.|||Percentage of participants|||Number
1352814|NCT01762761|Secondary|Post-hoc Estimates of Maximum Observed Concentration (Cmax) for Eltrombopag After 50 mg Once Daily Dose of Eltrombopag|Cmax is defined as maximum observed concentration after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag Cmax was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state Cmax of eltrombopag .is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Nanogram/ Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1352815|NCT01762761|Secondary|Post-hoc Estimates of Plasma Eltrombopag Area Under the Concentration-time Curve Over a Dosing Interval (AUC[0-tau]) After 50 mg Once Daily Dose of Eltrombopag|AUC[0-tau] is defined as area under the concentration-time curve over a dosing interval (24 hr) of Eltrombopag atsteady-state after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state AUC(0-tau) of eltrombopag is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Microgram* hour per milliliter(μg.hr/mL)||95% Confidence Interval|Geometric Mean
1352816|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Lag Time (ALAG)|Absorption lag time (ALAG) is defined as the time taken for a drug to appear in the systemic circulation following administration. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hrs and 5 to 8 hrs post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Hour||95% Confidence Interval|Geometric Mean
1352817|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Rate Constant (Ka)|Ka is defined as the absorption rate constant. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Per hour (1/hr)||95% Confidence Interval|Geometric Mean
1352818|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Apparent Clearance (CL/F), Apparent Inter-compartmental Clearance (Q/F)|CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Liters per hour(L/hr)||95% Confidence Interval|Geometric Mean
1352819|NCT01762761|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Volume of Distribution of Central Compartment (Vc/F), Apparent Volume of Distribution of Peripheral Compartment (Vp/F)|Vc/F is apparent volume of distribution of plasma (VDP) in central compartment and Vp/F is apparent VDP in peripheral compartment. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 minutes(min) for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population: all participants with evaluable dosing, actual sampling time, and eltrombopag concentration data.|||Liters||95% Confidence Interval|Geometric Mean
1352820|NCT01762761|Secondary|Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening|Bone marrow biopsy was performed at Screening and then obtained when clinically indicated. Whenever a peripheral blood smear confirmed the presence of immature or dysplastic cells, a bone marrow examination was performed. Myelofibrosis (MF) was graded from Grade MF-0 to MF-3 where MF-0=scattered linear reticulin with no intersections (cross-overs) corresponding to normal bone marrow; MF-1=loose network of reticulin with many intersections; especially in perivascular areas; MF-2=diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3=diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis.|Screening|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
1352821|NCT01762761|Secondary|Number of Participants With a Change From Baseline in Visual Acuity|Visual acuity is a measure of the spatial resolution of the visual processing system. Acuity is a measure of visual performance and is unrelated to the eyeglass prescription required to correct vision. Normal visual acuity is commonly referred to as 20/20 vision. Evaluation was done for oculus sinister (OS) for the left eye, oculus dexter (OD) for the right eye. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population|||Participants|||Number
1352822|NCT01762761|Secondary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Finding at Baseline|Resting 12-lead ECG was obtained at Baseline. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. ECG was also obtained when there was clinical symptom that potentially related to cardiac dysfunction based on investigator’s judgement.|Baseline|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Particpants|||Number
1352823|NCT01762761|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population|||Beats per minute||Standard Deviation|Mean
1352824|NCT01762761|Secondary|Change From Baseline in Diastolic Blood Pressure|Diastolic blood pressure was measured in sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population|||mm Hg||Standard Deviation|Mean
1352825|NCT01762761|Secondary|Change From Baseline in Systolic Blood Pressure|Systolic blood pressure was measured in the sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
1352826|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters|Clinical hematology parameters hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell count evaluations were performed at Baseline, at all on-therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the NCI CTCAE V4.0: Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
1352827|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), total bilirubin, albumin, alkaline phosphatase, calcium, potassium, creatinine, glucose and sodium were evaluated at Baseline, at all on therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE V4.0): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. For creatinine, Baseline is defined as the average of Screening and Day 1 values if available and prior to first dose. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
1352828|NCT01762761|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of study treatment (Day 1) up to the end of Week 8 of Stage 1|Safety Population: all randomized participants who received at least one dose of the study treatment.|||Participants|||Number
1352853|NCT01762059|Other Pre-specified|Mean Blood Sugar as Measured by Continuous Glucose Monitor (CGM) Readings||Days 2-5||||mg/dL||Standard Deviation|Mean
1352854|NCT01762059|Other Pre-specified|Fraction of Time Spent Within Each of the Following Glucose Ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl||Days 2-5||||percentage of time||Standard Deviation|Mean
1352829|NCT01762761|Secondary|Number of Participants That Reduced or Discontinued Baseline Concomitant ITP Medications During Stage 2 and Stage 3|The number of participants taking concomitant ITP medications on Day 1 of Stage 1 who had a decrease in the dose or frequency of ITP medication or stopped ITP medication at any point during Stage 2 or Stage 3 will be presented. The Baseline concomitant ITP medication for Stage 2 and Stage 3 is defined as ITP medications taken prior to the first dose of investigational product of Stage 1. This study is still ongoing and this endpoint can only be analyzed when the stage 2 and stage 3 complete.|From the start of Week 1 of Stage 2 to the end of last week of Stage 3||2019-11-30|11/2019||||
1352830|NCT01762761|Secondary|Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L|Maximum period of time a participant had a platelet count continously >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population|||Weeks||Inter-Quartile Range|Median
1352831|NCT01762761|Secondary|Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L|Total duration of time a participant had platelet count >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population|||Weeks||Inter-Quartile Range|Median
1352832|NCT01762761|Secondary|Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments|The number of participants with a platelet count >=50×10^9/L during at least 75% of their platelet count assessments was analyzed up to the end of Week 6 of Stage 1. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population|||Participants|||Number
1352833|NCT01762761|Secondary|Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1|Rescue treatment is defined as either a new ITP medication, an increase in dose of concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population|||Participants|||Number
1352834|NCT01762761|Secondary|Time to Response|Time to response is defined as time from the startin of treatment to the first time of achieving a platelet count >=50x10^9/L during the first 6 weeks of Stage 1. Time to response is summarized using Kaplan-Meier estimates and compared between treatment groups using a stratified log-rank test, stratifying for the use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no). The pike estimator of the treatment hazard ratio is based on the stratified log-rank test. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population.Only those participants (par.) with a response were analyzed (3 responders out of 50 participants in the placebo group and 60 responders out of 104 participants in the Eltrombopag group for calculating the statistics of time to response analysis).|||Weeks||95% Confidence Interval|Median
1352835|NCT01762761|Secondary|Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale grades were dichotomized into the following categories: no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4. Generalized linear mixed model with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population|||Participants|||Number
1352836|NCT01762761|Secondary|Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale were dichotomized to indicate no bleeding vs bleeding, i.e. 0=grade 0 and 1=grades 1, 2, 3 or 4. Generalized linear mixed model was applied with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect. Bleeding incidences were recorded at Screening, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. All Bleeding incidences at each visit are presented.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population|||Participants|||Number
1352837|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1|The number of participants achieving a platelet count >=30×10^9/L and at least 2 times the Baseline platelet count at least once during the first 6 weeks of Stage 1 were analyzed. The Baseline platelet count is defined as the platelet count taken on Day 1 of the study or within 48 hours prior to the first dose of investigational product. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population. One participant did not have a Baseline platelet count due to no platelet count collected on Day 1 or within 48 hours prior to the first dose of investigational product;therefore, this participant was not evaluable in this table.|||Participants|||Number
1352838|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50×10^9/L at least once during the first 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population|||Participants|||Number
1352839|NCT01762761|Primary|Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50x10^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1.|||Participants|||Number
1352840|NCT01762722|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.|||percentage saturation||Full Range|Mean
1352841|NCT01762501|Secondary|Change in 24-hour Mean Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
1352842|NCT01762501|Secondary|Change in 24-hour Mean Systolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
1352843|NCT01762501|Secondary|Change in Nocturnal Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
1352844|NCT01762501|Secondary|Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**|"Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent)~** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP"|Baseline and 8 weeks||||mmHg||95% Confidence Interval|Mean
1352845|NCT01762501|Primary|Change in Nocturnal Systolic Blood Pressure Level|"Change at the end of a treatment period (Week 8) from the beginning point of an observation period~*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)"|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
1352846|NCT01762345|Other Pre-specified|Percentage of Responders for SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||percentage of subjects|||Number
1352847|NCT01762345|Other Pre-specified|Percentage of Responders for Pad Weight Gain||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||percentage of subjects|||Number
1352848|NCT01762345|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = ‘Not at all,’ 1= ‘Slightly,’ 2 = ‘Moderately,’ or 3 ‘Greatly.’ The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at the end of treatment"|||units on a scale||Inter-Quartile Range|Median
1352849|NCT01762345|Secondary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||episodes/usage period||Inter-Quartile Range|Median
1352850|NCT01762345|Secondary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||grams/usage period||Inter-Quartile Range|Median
1352851|NCT01762345|Primary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||episodes/usage period||Inter-Quartile Range|Median
1352861|NCT01762059|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All GlucoScout and HemoCue Measurements.|"Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean):~< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl"|5 Days|Data were not collected||||||
1352862|NCT01762059|Secondary|Average BG During the Closed-loop Control Period as Determined From All GlucoScout Measurements Taken During the Nighttime Monitoring.|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||mg/dl||Standard Deviation|Mean
1352863|NCT01762059|Secondary|Correlation Between Exercise Intensity and Likelihood of a Hypoglycemic Event||5 days|Data were not collected||||||
1352864|NCT01762059|Secondary|Nadir BG During Exercise.||5 days|Data were not collected||||||
1352865|NCT01762059|Secondary|Number of Hypoglycemic Events as Determined From GlucoScout and HemoCue Measurements.||5 days|Data were not collected||||||
1352866|NCT01762059|Secondary|Difference in the Percentage of Subjects With Mean BG < 154 mg/dl During the Closed-loop Period vs. the Usual Care Period.||5 days|Data were not collected||||||
1352867|NCT01762059|Secondary|Percentage of Subjects With Mean BG < 154 mg/dl.|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||percentage of participants|||Number
1352868|NCT01762059|Secondary|Difference in the Percentage of the Above Subset of BG Values Between the Closed-loop Control and Usual Care Periods Less Than 70 mg/dl.||5 days|Data were not collected||||||
1352869|NCT01762059|Secondary|Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period.||5 days|Data were not collected||||||
1352870|NCT01762059|Secondary|Percentage of the Subset of BG Values Less Than 70 mg/dl as Determined From All All HemoCue Measurements Taken During the Daytime and Scheduled GlucoScout Measurements Taken During the Nighttime.||5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||percentage of time||Standard Deviation|Mean
1352871|NCT01762059|Secondary|Average BG During the Closed-loop Control Period as Determined From All HemoCue Measurements Taken During the Daytime and All Scheduled GlucoScout Measurements During the Nighttime.|During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||mg/dl||Standard Deviation|Mean
1352872|NCT01762059|Primary|Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)|"Percentage of time blood glucose values during the closed-loop control period less than 70 mg/dl determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime) during day 1-5.~During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm"|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||percentage of time||Standard Deviation|Mean
1352873|NCT01762059|Primary|Average Blood Glucose (Co-primary Outcome)|Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).|5 days of closed-loop control|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||mg/dL||Standard Deviation|Mean
1352874|NCT01761747|Secondary|Define the Response Rate to Ponatinib is Patients With FGFR Amplifications Versus Mutations|Identify the response rate to ponatinib for FGFR specific FGFR amplifications/mutations.|2 years|There were no observed responses on study so this outcome could not be determined.||||||
1352875|NCT01761747|Secondary|Determine the Correlation FGFR Amplifications/Mutations With Patient Age, Sex, Disease Stage, Prior Response to Treatment and Smoking History|For subjects with FGFR amplifications and for FGFR mutations we will ascertain the age, sex, disease stage, prior response to treatment and smoking history from past medical records and measure whether there are differences in these variables among subjects with amplification versus mutation.|2 years|Too few subjects were enrolled on study to permit this outcome measure analysis.||||||
1352876|NCT01761747|Secondary|Disease Control|Measure the disease control rate of patients treated with ponatinib|2 years||||percentage of subjects|||Number
1352877|NCT01761747|Secondary|Overall Survival|Measure the overall survival time of patients treated with ponatinib|2 years||||days||Full Range|Mean
1352878|NCT01761747|Secondary|Define Toxicities of Ponatinib|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|2 years||||participants|||Number
1352879|NCT01761747|Secondary|Progression-free Survival|Establish the progression-free survival of patients with SCC treated with ponatinib as defined by time to development of progression by RECIST criteria.|2 years||||days||Full Range|Mean
1352880|NCT01761747|Secondary|Prevalence of Specific FGFR Amplifications/Mutations in the Study Population|Test tumor DNA using molecular assays to measure the frequency of FGFR amplifications and mutations in study patients|2 years|2 participants had FGFR amplification, one with FGFR mutation|||participants|||Number
1352881|NCT01761747|Primary|Response Rate of Patients With Lung or Head and Neck SCC Treated With Ponatinib|"Investigate the response rate of patients with previously treated lung or head and neck SCC to ponatinib as defined by the proportion of subjects with investigator-assessed confirmed complete response (CR) or partial response (PR).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years||||percentage of subjects with response|||Number
1352882|NCT01761565|Primary|CST½|the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration|24|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||hours||Full Range|Median
1352883|NCT01761565|Primary|Time to Steady State|Steady state, for the cohort, was assessed using Helmert’s method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05)|24 hours|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||hours|||Number
1352884|NCT01761565|Primary|Cmax|"For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1.~For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3"|24 hours in Treatment A, 37 hours in Treatment B|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||pg/mL||Standard Deviation|Mean
1352885|NCT01761279|Other Pre-specified|Accuracy of Prediction of Polyp Surveillence Intervals|Accuracy of prediction of post-polypectomy surveillence colonoscopy intervasl based on national guidelines. Intervals based on in-vivo assessment of all polyps ≤5mm in size combined with histopathology of polyps >5mm in size will be compared to intervals determined by histopathology of all polyps|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|84 study participants in total. One patient excluded from this analysis as a single polyp was not retrieved for histological analysis.|||Percentage correct surveillence interval|||Number
1352886|NCT01761279|Secondary|Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size|Negative predictive value for adenomatous histology of rectosigmoid polyps ≤5mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. NPV compared to the gold standard of histopathology. Negative predictive value = number of true negatives/(number of true negatives + number of false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|Numbers indicate the number of rectosigmoid polyps <5mm in size assessed as being non-neoplastic|||Percentage Negative Predictive Value|Participants|95% Confidence Interval|Number
1352887|NCT01761279|Secondary|Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size|Specificity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Specificity compared to the gold standard of histopathology. Specificity for adenomatous histology = number of correctly identified non-neoplastic polyps (true negatives)/total number of non-neoplastic polyps (true negatives + false positives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|75 is the number of non-neoplastic polyps included in the study.|||Percentage specificity|Participants|95% Confidence Interval|Number
1352888|NCT01761279|Secondary|Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size|Sensitivity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Sensitivity compared to the gold standard of histopathology. Senstivity for adenomatous histology = number of correctly identified adenomas (true positives)/total number of adenomas (true positives + false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|134 is the number of adenomatous polyps included in the study.|||Percentage sensitivity|Participants|95% Confidence Interval|Number
1352889|NCT01761279|Primary|Diagnostic Accuracy of In-vivo Polyp Assessment|Diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Accuracy compared to the gold standard of histopathology. Accuracy - number of polyps with histology correctly predicted by in-vivo method/total number of polyps assessed (Expressed as a percentage)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|There were 84 patients included in the study. 209 polyps <10mm included in the study.|||% diagnostic accuracy|Participants|95% Confidence Interval|Number
1352890|NCT01761175|Secondary|Duration of Tourniquet|The total time the tourniquet was left inflated|The end of surgery||||minutes||Inter-Quartile Range|Median
1352891|NCT01761175|Secondary|Tourniquet Use|Number of participants who had a tourniquet during the surgery|The end of surgery|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||participants|||Number
1352892|NCT01761175|Secondary|Duration of Surgery||The end of surgery|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||minutes||Inter-Quartile Range|Median
1352893|NCT01761175|Secondary|Number of Patients With Postoperative Adverse Events Related to Nerve Block|Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.|1 month after surgery|Eight patients in the infraclavicular group and five in the axillary group could not be contacted in the pre-established time frame.|||participants|||Number
1352894|NCT01761175|Secondary|Number of Patients With Postoperative Adverse Events Related to Nerve Block|Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.|24 hours after surgery|Four patients in the infraclavicular group and six in the axillary group could not be contacted in the pre-established time frame.|||participants|||Number
1352895|NCT01761175|Secondary|Procedure-related Pain on a Visual Analog Pain Scale|Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life).|After the nerve block procedure ended, up to 5 minutes.|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success. This patient was not included in the other secondary outcomes. 3 other participants had missing data for this outcome.|||units on a scale||Inter-Quartile Range|Median
1352896|NCT01761175|Secondary|Performance Time of the Nerve Block|Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal).|During the performance of the block|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||seconds||95% Confidence Interval|Mean
1352897|NCT01761175|Secondary|Surgical Block Success Rate|Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia.|End of surgery||||percentage of participants||95% Confidence Interval|Number
1352898|NCT01761175|Secondary|Time to Complete Motor Block|Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.|5, 10, 15, 20, 25 and 30 minutes after block completion|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||percentage of participants||95% Confidence Interval|Number
1352899|NCT01761175|Secondary|Time to Complete Sensory Block.|Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.|5, 10, 15, 20, 25 and 30 minutes after block completion|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||percentage of participants||95% Confidence Interval|Number
1352900|NCT01761175|Secondary|Number of Patients With Complete Motor Blocks|Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.|30 minutes after block completion||||percentage of participants||95% Confidence Interval|Number
1352901|NCT01761175|Primary|Number of Patients With Complete Sensory Block|Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.|30 minutes after block completion|Statistical analyses were conducted according to the intention-to-treat principle|||percentage of participants||90% Confidence Interval|Number
1352902|NCT01761162|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1352903|NCT01761162|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1352904|NCT01761162|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1352905|NCT01761162|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
1352906|NCT01761162|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
1352907|NCT01761019|Secondary|Desire to Change to Another Systemic Therapy|We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.|12 weeks||||Percentage of participants|||Number
1352908|NCT01761019|Secondary|Patient Satisfaction|"• Subject satisfaction: We also ask subjects for their level of satisfaction with their current treatment at week 12. They will be given the following options: very satisfied, satisfied, somewhat disappointed or very disappointed. For measurement very satisfied=4, satisfied=3, somewhat disappointed=2 and very disappointed=1. We will determine the mean satisfaction of all patients at week 12."|12 weeks||||units on a scale||Standard Deviation|Mean
1352909|NCT01761019|Secondary|Safety|Throughout this study, adverse events and serious adverse events will be collected|12 weeks||||adverse event|||Number
1352910|NCT01761019|Secondary|Body Surface Area|This is a measure of the percentage of the body involved with psoriasis. We will measure the change in percentage of body area involved with psoriasis from baseline to week 12.|12 weeks||||percentage of body surface area||Standard Deviation|Mean
1352911|NCT01761019|Primary|Investigator Global Assessment|This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.|12 weeks||||units on a scale||Standard Deviation|Mean
1352912|NCT01760993|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352913|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352914|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 52|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352918|NCT01760993|Primary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352919|NCT01760993|Primary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352920|NCT01760993|Primary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352921|NCT01760993|Primary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352922|NCT01760993|Primary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352923|NCT01760993|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352924|NCT01760993|Primary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352925|NCT01760993|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks||Basline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352926|NCT01760941|Other Pre-specified|Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile|Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile|6 months|||||||
1352927|NCT01760941|Secondary|Evaluate the Treatment Influence on Patient Quality of Life|Evaluate the treatment influence on patient quality of life as measured by the ESAS.|2 weeks|||||||
1352928|NCT01760941|Secondary|Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction|Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.|2 weeks|||||||
1352929|NCT01760941|Primary|Feasibility of Treatment Delivery in the Same Day as Initial Evaluation|Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey|Up to 6 months|||||||
1352930|NCT01760889|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352931|NCT01760889|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352932|NCT01760889|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352933|NCT01760889|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352934|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352935|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 26|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352936|NCT01760889|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352937|NCT01760889|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352938|NCT01760889|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352939|NCT01760889|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352940|NCT01760889|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352941|NCT01760889|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352942|NCT01760889|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352943|NCT01760889|Primary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1352944|NCT01760876|Secondary|OCT Endpoints (Neointimal Metrics), QCA Endpoints (Late Lumen Loss at 9 Months), and Clinical Endpoints (MACE at 9 Months and 12 Months). A Subgroup Analysis Would be Performed for Diabetic Patients.|Secondary endpoints would consist of OCT endpoints (neointimal area, neointimal thickness, neointimal volume, and percentage neointimal volume ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, including stent thrombosis up to 12 months). A subgroup analysis will be performed for DM patients.|9 months and 12 months||2017-12-31|12/2017||||
1352945|NCT01760876|Primary|OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months.|"The percentage of strut coverage and category of coverage (A to F) from 1 month to 9 months by longitudinal sequential OCT assessments.~A. Definitely uncovered – strut not covered by tissue, and both sides appear square; B. Uncovered with abnormal in-stent tissue – strut covered by irregular tissue or fibrin, and both sides appear square; C. Partially uncovered – strut partially covered by tissue but only one side has a smooth continuous shoulder; D. Covered (protruding) – strut covered by thin continuous tissue on both sides but still extending into the lumen; E. Covered (embedded) – strut covered by continuous tissue or neointima and not interrupting the smooth lumen contour; F. Covered (proliferative) – strut covered with excessive growth of neointima with thickness >0.3 mm."|1 to 9 months|100 patients treated with BF stents and randomly assigned to 5 monthly groups (n = 20:20:20:20:20) at 1 to 5 months receiving OCT follow-up, and then 100 patients altogether at 9 months for another follow-up.|||percentage of strut coverage (D+E+F)||Inter-Quartile Range|Median
1352946|NCT01760785|Secondary|Frequency of Alcohol Use|Frequencies of alcohol use/misuse will be measured weekly utilizing the Timeline Followback assessment. Participants will also be given an alcohol breath test at every clinic visit.|Weeks 1-10|||||||
1352947|NCT01760785|Primary|Severity of Affective Lability Based on Shortened Agitated Behavior Scale|Severity of affective lability was measured using a shortened version of the Agitated Behavior Scale (ABS). The ABS is used to assess the nature and extent of present agitation. Eight items from the 14-item scale were used, which measured the presence and severity of various affective lability symptoms including: short attention span, impulsivity, uncooperative behavior, violent tendencies, restlessness, rapid or excessive talking, sudden changes in mood, and easily initiated or excessive crying and/or laughter. Each of the eight items was scored using a 1-4 Likert scale, where 1 stands for absence of symptom and 4 stands for presence to an extreme degree. The minimum possible score for this measure was 8, and the maximum possible score was 32. Due to the nature of the measure, a lower score indicated less severe affective lability, while conversely higher scores indicated more severe affective lability. The mean of scores for weeks 2 through 8 for each group were reported.|Weeks 2 through 8||||units on a scale||Standard Error|Mean
1352948|NCT01760473|Secondary|SOWS|Subjective opioid withdrawal scale (SOWS) measure (0-64). Greater score indicates more severe withdrawal.|Throughout the testing sessions (approximately 9 weeks).||||units on a scale||Standard Error|Mean
1352949|NCT01760473|Primary|Drug Self-administration|The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.|Throughout the testing sessions (approximately 9 weeks).||||Clicks on a computer mouse||Standard Error|Mean
1352950|NCT01760304|Secondary|Evaluation of O2 Pulse|Evaluation of O2 Pulse is the measurement of oxygen consumption pre and post intervention|Change from Baseline and 45 minutes after administration of study medication or placebo||||ml/beat||95% Confidence Interval|Mean
1352951|NCT01760304|Secondary|Lung Hyperinflation|Evaluation of lung hyperinflation as determined by Pulmonary function test where Inspiratory Capacity (IC) before and 45 minutes after the administration of the budesonide/formoterol or placebo.|Change from Baseline and after 45 minutes after administration of study medication or placebo||||Liters||95% Confidence Interval|Mean
1352952|NCT01760304|Primary|Cardiac Output|"Impedance cardiography (ICG) (BioZ Dx ICG machine, by CardioDynamics) was used to measure cardiac output without the need for invasive devices. Cardiac output measurement by impedance cardiography (CO-ICG) is a plethysmography technique using sensors to detect the properties of the blood flow in the thorax.~All subjects had on each visit a baseline measurement at rest and then 45 minutes after intervention (Budesonide/formoterol or Placebo). Measurement were performed at rest for 5 minutes to obtain a steady state and the last 2 minutes were taken for analysis as an averaged value labeled as pre and post intervention. For the analysis we calculated the difference from pre and post intervention at each visit. Paired t-test was used to compare the mean+/- SD of the pre and post difference when taking the study drug vs placebo."|Change from Baseline and at 45 minutes after administration of study medication or placebo||||ml/beat||95% Confidence Interval|Mean
1352953|NCT01759602|Secondary|Expanded Disability Status Score (EDSS)|"The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of patients with multiple sclerosis. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers.~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. In addition, it also provides eight subscale measurements called Functional System (FS) scores."|participants were followed for the duration of hospital stay ranging from 5-21 days, an average of 13 days; EDSS assessment was administered at discharge||||EDSS scores||Full Range|Median
1352954|NCT01759602|Secondary|Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters.|"ALT elevations were considered mild if they rose to less than 4-fold baseline levels."|5-21 days||||participants|||Number
1352955|NCT01759602|Secondary|Percentage of Subjects Withdrawing Due to Adverse Events.||5-21 days||||percentage of subjects withdrawing|||Number
1352956|NCT01759602|Secondary|Frequency of Serious Adverse Events.||5-21 days||||serious adverse events|||Number
1352957|NCT01759602|Primary|Number of Adverse Safety Events During Hospitalization|Over the course of hospitalization for the acute NMO exacerbations, subjects will be monitored daily for frequency of adverse events.|5-21 days||||adverse safety events|||Number
1352958|NCT01759511|Secondary|Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120||Weeks 72 and 120|Participants in the Safety Analysis set with available data were analyzed.|||percent change in sLOXL2||Standard Error|Least Squares Mean
1352959|NCT01759511|Secondary|All-cause Mortality|All-cause mortality was assessed as a number of participants who died from any cause.|Up to 165 weeks|Safety Analysis Set|||Participants|||Count of Participants
1353047|NCT01759160|Secondary|CVP (Central Venous Pressure)|CVP was continuously monitored to assess preload condition and served to calculate SVRI (systemic vascular resistance index) every minute during the first 25 minutes of infusion.|25 minutes after induction|||||||
1352960|NCT01759511|Secondary|Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144|"DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.~Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144."|Weeks 72 and 144|Participants in Safety Analysis Set with available data were analyzed.|||percent change in DLCO % predicted||Standard Error|Least Squares Mean
1352961|NCT01759511|Secondary|Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144|"FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.~Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144."|Weeks 72 and 144|Participants in Safety Analysis Set with available data were analyzed.|||percent change in FVC % predicted||Standard Error|Least Squares Mean
1352962|NCT01759511|Primary|Overall Safety Profile of Simtuzumab|The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.|30 days post last study treatment (up to 165 weeks)|Safety Analysis Set|||percentage of participants|||Number
1352963|NCT01759420|Secondary|Number of Adverse Events|The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient. All of these outcomes will be recorded for each patient during the emergency department stay which could range from 20 minutes to several hours.|20 minutes to 8 hours||||percentage of patients||95% Confidence Interval|Number
1352964|NCT01759420|Primary|Change in QTc Interval With Ondansetron Administration|The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. A baseline EKG will be obtained and then after drug administration an EKG will be performed every 2 minutes until 20 minutes has passed. The mean maximal QTc change will be calculated.|Baseline to 20 minutes||||mS||95% Confidence Interval|Mean
1352965|NCT01759407|Secondary|Time to First Opioid Dose|Median time between PACU discharge and first opioid dose on the ward.|From PACU discharge until first opioid dose on the ward, assessed up to 24 hours||||hours||Inter-Quartile Range|Median
1352966|NCT01759407|Secondary|Intraoperative End-tidal Isoflurane %|Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.|1 1/2 hr.||||percentage of isoflurane||Inter-Quartile Range|Median
1352967|NCT01759407|Primary|Post-anesthesia Care Unit (PACU) Pain Scores|Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.|30 mins after surgery||||pain score||Inter-Quartile Range|Median
1352968|NCT01759381|Primary|Number of Participants With Post-operative Infection (NPWT)|The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.|3 months||||participants|||Number
1352969|NCT01759368|Secondary|Utilization of Health Care Resources|Number of visits to nurse's reception|From baseline until the end of the study at six months||||number of visits||Standard Deviation|Mean
1352970|NCT01759368|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline until the end of the study|From baseline until the end of the study at six months||||percentage unit||95% Confidence Interval|Mean
1352971|NCT01759368|Other Pre-specified|Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study|Change in plasma concentrations of creatinine, natrium, and potassium|From baseline to the end of the study at six months|||||||
1352972|NCT01759368|Secondary|EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores|Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed.|From baseline until the end of the study at six months||||Scores on a scale||95% Confidence Interval|Mean
1352973|NCT01759368|Secondary|P-proBNP|Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.|From baseline until the end of the study at six months||||ng/l||Inter-Quartile Range|Median
1352974|NCT01759368|Secondary|Heart Transplant|Heart transplant operation or listing for transplant operation|From baseline until the end of the study at six months||||participants|||Number
1352975|NCT01759368|Secondary|Death|Death from any cause|From baseline until the end of the study at six months||||participants|||Number
1352976|NCT01759368|Primary|Number of HF-related Hospital Days|Number of heart failure related hospital days|From baseline until the end of the study at six months||||number of days||Standard Deviation|Mean
1352977|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352978|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353048|NCT01759160|Secondary|NI (Narcotrend Index) Reduction|Narcotrend was utilized to continuously record patients' sedation level during induction, provided as a criteria for Cpt (Plasma Target Concentration) adjustment.|25 minutes after propofol infusion|||||||
1352979|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352980|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352981|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352982|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352983|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352984|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352985|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352986|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352987|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352988|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352989|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352990|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352991|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352992|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352993|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352994|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352995|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352996|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352997|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352998|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1352999|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353000|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353001|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353002|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353003|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353004|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353005|NCT01759290|Secondary|All Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353006|NCT01759290|Secondary|Cardiac Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353007|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353008|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353009|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353010|NCT01759290|Secondary|All Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353011|NCT01759290|Secondary|Cardiac Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353012|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353013|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353014|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353015|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353016|NCT01759290|Secondary|All Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353017|NCT01759290|Secondary|Cardiac Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353418|NCT01753557|Primary|Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||48 weeks||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1353018|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353019|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 - 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353020|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353021|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353022|NCT01759290|Secondary|All Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353023|NCT01759290|Secondary|Cardiac Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353024|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353025|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353026|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353027|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353028|NCT01759290|Secondary|Late Scaffold Thrombosis||31 to 365 Days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.|||percentage of participants|||Number
1353029|NCT01759290|Secondary|Subacute ScaffoldThrombosis||1 to 30 days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.|||percentage of participants|||Number
1353030|NCT01759290|Secondary|Acute Scaffold Thrombosis||<1 day|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.|||percentage of participants|||Number
1353049|NCT01759160|Primary|SVI (Stroke Volume Index) Value Change From Baseline Level at the End of the First 25 Minutes.|After propofol infusion started, according to sedation level, TCI targets were gradually titrated to reach a state of equilibrium at the end of the first 25 minutes. SVI were continuously monitored, at the end of the first 25 minutes, value change from baseline level were calculated.|The end of the first 25 minutes after propofol infusion||||ml/beat/m^2||Standard Deviation|Mean
1353031|NCT01759290|Secondary|Acute Success: Clinical Procedure Success (Per Subject Analysis)|Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.|During the hospital stay with a maximum of 3 days post index procedure||||percentage of participants||95% Confidence Interval|Number
1353032|NCT01759290|Secondary|Acute Success: Clinical Device Success (Lesion Level Analysis)|Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.|< or = 1 day||||percentage of lesions|Participants|95% Confidence Interval|Number
1353033|NCT01759290|Primary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
1353034|NCT01759264|Secondary|Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment|CR70 and CR100 was a decrease from baseline (Week 0) in CDAI score of 70 and 100 or more points, respectively, a lower score indicating improvement in disease activity.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
1353035|NCT01759264|Secondary|Percentage of Participants With Remission of Crohn's Disease|Crohn's Disease Activity Index (CDAI) was a composite index consisting of a weighted scoring of eight disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, a higher score indicates increased disease severity. Clinical remission was defined as CDAI score less than 150.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
1353036|NCT01759264|Secondary|Mean Percent Change of Fecal Calprotectin From Baseline|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage||Standard Deviation|Mean
1353037|NCT01759264|Primary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 4|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
1353038|NCT01759264|Secondary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 8 and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
1353039|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
1353040|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
1353041|NCT01759251|Secondary|Overall Clinical Response Assessed by Patient|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
1353042|NCT01759251|Secondary|Overall Clinical Response Assessed by Physician|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
1353043|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period||From 2 months to 4 months|||||||
1353044|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period||From Day 0 to 2 months|||||||
1353045|NCT01759251|Secondary|Change of the Patient’s Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period|determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|From Day 0 to 2 months|||||||
1353046|NCT01759251|Primary|Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|Number of patients with clinical response on treatment determined with SVVSLCRE|Up to 2 months|60 days treatment group|||participants|||Number
1353051|NCT01758900|Secondary|Abdominal Circumference|To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure.|10 minutes before/after the examination||||centimeter||Standard Deviation|Mean
1353052|NCT01758900|Secondary|Procedure Time||Within 5 minutes after the examination||||minutes||Standard Deviation|Mean
1353053|NCT01758900|Secondary|Patient's Acceptability|Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled “no pain/distention” on left end and the 10-cm point labeled “very severe pain/distention that cannot be tolerated” on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination.|6 hours after the examination||||participants|||Number
1353054|NCT01758900|Secondary|Diagnostic Rate||Within 1 week after all the examinations are finished||||Percentage of Participants|||Number
1353055|NCT01758900|Secondary|Total Enteroscopy Rate||Within 1 week after all the examinations are finished||||participants|||Number
1353056|NCT01758900|Primary|Intubation Depth||Within 5 minutes after the examination||||cm||Standard Deviation|Mean
1353057|NCT01758588|Secondary|Overall Survival|"Overall survival measures subject survival regardless of disease progression.~Overall survival will be assessed at 21 weeks from time of study entry."|Week 21|Due to early termination of the trial, there is not enough data to evaluate overall survival.|||Participants|||Count of Participants
1353058|NCT01758588|Secondary|Progression Free Survival|"Progression free survival is the measure of subject survival in the absence of disease progression. Disease progression is defined as progression to the next higher International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Dynamic International Prognostic Scoring System (DIPSS) stage from diagnosis. The IWG-MRT DIPSS stratifies primary myelofibrosis (PMF) into four risk categories (low, intermediate 1, intermediate 2, and high risk), based on 5 clinical factors; Age>65, Hemoglobin <10gm/dL, white blood cell (WBC)>25,000/uL, peripheral blasts>1%, and constitutional symptoms.~Progression free survival will be assessed at 21 weeks from time of study entry."|Week 21|Analysis population includes subjects who were evaluable at 21 weeks from time of study entry.|||Participants|||Count of Participants
1353059|NCT01758588|Primary|Clinical Improvement|"Clinical improvement (CI) Requires one of the following in the absence of both disease progression (as outlined below) and Complete Response (CR)/Partial Response (PR) assignment (CI response is validated only if it lasts for no fewer than 8 weeks) i. A minimum 20-g/L increase in hemoglobin level or becoming transfusion independent (applicable only for patients with baseline hemoglobin level of less than 100 g/L).~ii. Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable.~iii. A minimum 100% increase in platelet count and an absolute platelet count of at least 50 000 109/L (applicable only for patients with baseline platelet count below 50 109/L).~iv. A minimum 100% increase in Absolute Neutrophil Count (ANC) and an ANC of at least 0.5 109/L (applicable only for patients with baseline absolute neutrophil count below 1 109/L)."|One year||||Participants|||Count of Participants
1353060|NCT01758432|Secondary|Andexanet Apparent Terminal Elimination Half-life (t1/2)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electro chemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration–time curve.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||hr||Standard Deviation|Mean
1353061|NCT01758432|Secondary|Andexanet Total Systemic Clearance (CL)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||L||Standard Deviation|Mean
1353062|NCT01758432|Secondary|Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||ng*hr/mL||Standard Deviation|Mean
1353063|NCT01758432|Secondary|Andexanet Total Volume of Distribution (Vss)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||L||Standard Deviation|Mean
1353064|NCT01758432|Secondary|Andexanet Time of Maximum Observed Plasma Concentration (Tmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||hr||Full Range|Median
1353065|NCT01758432|Secondary|Andexanet Maximum Observed Plasma Concentration (Cmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||ng/mL||Standard Deviation|Mean
1353186|NCT01756079|Primary|Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period|||Percentage of participants|||Number
1353066|NCT01758432|Secondary|Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration|Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|54 subjects who received apixaban were included in the apixaban pharmacokinetics (PK) analysis|||% change in unbound apixaban concentrat.||Standard Deviation|Mean
1353067|NCT01758432|Secondary|Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration|Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|45 subjects who received andexanet or placebo were included in the PD analysis|||Percent change in thrombin generation||Standard Deviation|Mean
1353068|NCT01758432|Primary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration|Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)|Baseline to 2 minutes following the end of andexanet/placebo administration|54 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis|||Percent change in anti-fXa activity||Standard Deviation|Mean
1353069|NCT01758289|Secondary|Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)|Participants with a complete, valid assessment at given time point.|||units on a scale||Standard Deviation|Mean
1353070|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.|||units on a scale||Standard Deviation|Mean
1353071|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from ‘no problem’ to ‘extreme problem’) best describes their health state.|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.|||participants|||Number
1353072|NCT01758289|Secondary|Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks|Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).|Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|All participants; n=number of participants with valid PTH values at given time point.|||participants|||Number
1353073|NCT01758289|Secondary|Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL|Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).|Baseline to Week 12, Week 12 to Week 24|All participants; n=participants with valid PTH values at given time point.|||participants|||Number
1353074|NCT01758289|Secondary|Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24|"Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL.~Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL.~Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL)."|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.|||percentage of participants|||Number
1353075|NCT01758289|Primary|Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit||Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|Participants with valid PTH values at Baseline and Final Study Visit.|||percentage of participants|||Number
1353076|NCT01757964|Primary|Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring|The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.|2 weeks||||participants|||Number
1353077|NCT01757847|Secondary|Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months|The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.|post treatment (4 weeks), 3 months, 6 months|Participants with measurement at baseline and at least one other time point.|||units on a scale||Standard Deviation|Mean
1353078|NCT01757847|Primary|Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months|This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.|post treatment (4 weeks), 3 months, 6 months|participants with measurement at baseline and at least one other time point.|||units on a scale||Standard Deviation|Mean
1353079|NCT01757821|Primary|Change in Cortical Excitability: Paired-Pulse|Cortical Excitability of the primary motor cortex on the stroke hemisphere will be assessed using paired-pulse transcranial magnetic stimulation.|Change from Baseline to 20 minutes||||milivolt||Standard Deviation|Mean
1353080|NCT01757717|Secondary|Number of Grade 3 of Higher Toxicities|For previously irradiated lesions of the spine and/or pelvis, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment|1 year||||brachytherapy related complications|||Number
1353081|NCT01757717|Primary|Maximum Radiation Dose|Verify feasibility of HDF treatment of spinal and/or pelvic lesions using catheters placed under image-guided navigational techniques, to provide improved dosimetric coverage of lesions such that Cord/Cauda Dmax of <8 Gy|1 year||||cord/cauda max dose in Gy||Full Range|Median
1353082|NCT01757704|Primary|Duration of the De-airing Procedure|The de-airing procedure is deemed completed when the Trans-esophageal Echocardiography (TEE) no longer visualizes air emboli in the heart Chambers. The duration is likely to vary between individuals and reflects the complexity of the de-airing procedure.|Time from release of aortic crossclamp to finished de-airing||||Minutes||Inter-Quartile Range|Median
1353083|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|6-10 minutes after finished de-airing||||Participants|||Number
1353084|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|3-6 minutes after finished de-airing||||Participants|||Number
1353085|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|0-3 minutes after finished de-airing||||Participants|||Number
1353086|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Period of ten minutes after finished de-airing||||Air microemboli||Inter-Quartile Range|Median
1353087|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from cardiac ejection to finished de-airing, an average of 5-10 minutes||||Air microemboli||Inter-Quartile Range|Median
1353088|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes||||Air microemboli||Inter-Quartile Range|Median
1353089|NCT01757691|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60|Safety population consited of all patients who received at least one dose of study medication|||Participants|||Number
1353090|NCT01757691|Secondary|Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48|||||||
1353091|NCT01757691|Secondary|Vision Based Quality of Life (QoL) Utility Score|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48|||||||
1353092|NCT01757691|Secondary|Low Contrast Visual Acuity (LCVA)|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 48|||||||
1353093|NCT01757691|Primary|Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo|Due to early termination and low patient enrollment the primary outcome measure was not analyzed|Baseline and Week 18|||||||
1353094|NCT01757678|Post-Hoc|Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA||1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|Patients with intermediate stenosis severity (30%-70%) according to coronary CTA.|||percentage of tests||95% Confidence Interval|Number
1353095|NCT01757678|Secondary|Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA||1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|22 of the 276 enrolled subjects were excluded from the analysis by the FFR/QCA Core Lab.|||percentage of tests|Vessels|95% Confidence Interval|Number
1353096|NCT01757678|Secondary|Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA||1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|22 of the 276 enrolled subjects were excluded from the analysis by the FFR/QCA Core Lab.|||percentage of tests||95% Confidence Interval|Number
1353097|NCT01757678|Primary|AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis|The primary statistical measure will be the area under the receiver operating characteristic curve (AUC of ROC) of a patient-based model to detect hemodynamically significant obstruction. ROC graphs the change in sensitivity as the cut-point for positive/negative diagnosis moves from its lower to upper limit. FFR is used as the reference standard to determine the presence or absence of hemodynamic obstruction. For FFR, hemodynamically-significant obstruction of a coronary artery is defined as an FFR≤0.80 in any major epicardial coronary artery segment with diameter ≥2.0 mm during adenosine-mediated hyperemia. For cCTA, hemodynamically-significant obstruction of a coronary artery is defined as a stenosis >50% . FFRCT will be calculated for each patient as the minimum FFRCT in any coronary artery segment . cCTA stenosis will be calculated for each patient as the highest cCTA stenosis category for any vessel all measurements will take place only in segments with diameter ≥2.0 mm.|1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|22 of the 276 enrolled subjects were excluded by the FFR/QCA Core Lab, leaving an ITD population of 254 subjects. 3 additional subjects were excluded from the ITD analysis due to missing cCTA 30%-90% stenosis by coronary CTA.|||probablility||95% Confidence Interval|Number
1353098|NCT01757678|Secondary|AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-vessel Basis||1 day|22 of the 276 enrolled subjects were excluded by the FFR/QCA Core Lab, leaving an ITD population of 254 subjects. 3 additional subjects were excluded from the ITD analysis due to missing cCTA 30%-90% stenosis by coronary CTA.|||probability|Vessels|95% Confidence Interval|Number
1353099|NCT01757561|Other Pre-specified|Blood Gas Analysis|including artery blood and blood from jugular vein bulb|baseline,every hour in the operation,after extubation|||||||
1353100|NCT01757561|Other Pre-specified|Vital Signs|heart rate, artery blood pressure,pulse oxygen saturation,temperature|baseline , evey hour in the operation,afte extubation|||||||
1353101|NCT01757561|Secondary|the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia||before anesthesia,after extubation,1 day after operation|||||||
1353102|NCT01757561|Secondary|the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia||before anesthesia, after extubation ,1day after operation|||||||
1353103|NCT01757561|Secondary|the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia|The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline.|1-3days、5-7days after operation||||participants|||Number
1353104|NCT01757561|Primary|the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia|SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2<50%.|baseline ,every hour in the operation period,after extubation||||participants|||Number
1353105|NCT01757405|Secondary|Percentage of Participants With Inhibitor Development to FVII|Development of rFVII inhibitors or FVIIa binding antibodies during the study.|6 months (throughout study period)|Safety Analysis Dataset|||percent of participants|||Number
1353106|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).~Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judges the AE to be possibly related or probably related to rFVIIa BI.~The percentage of AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related [to rFVIIa BI])."|6 months (throughout study period)|Safety Analysis Dataset|||percent of AEs|adverse events||Number
1353107|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Percentage of Participants With Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).~Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judged the AE to be possibly related or probably related to rFVIIa BI.~The percentage of participants with AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related to rFVIIa BI)."|6 months (throughout study period)|Safety Analysis Dataset|||percent of participants with AEs|||Number
1353280|NCT01754922|Primary|Heart Rate Variability|Ratio of low-frequency to high-frequency power for heart rate variability|Resting baseline; cross-sectional|Signal quality of the the electrocardiogram was poor for 3 individuals; therefore, their data were removed from final analysis.|||Ratio||Standard Deviation|Mean
1353108|NCT01757405|Secondary|Percentage of Clinical Responders (Sustained Bleeding Control) for All Acute Bleeding Episodes|Clinical responders defined as sustained bleeding control, (no additional hemostatic medication including rFVIIa BI required between 12 and 24 hours after first infusion of the successfully treated bleeding episode).|24 hours post infusion|Full Analysis Dataset|||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
1353109|NCT01757405|Secondary|Treatment Response for Each Bleeding Episode|"Participants rated the treatment of each bleeding episode. If treatment occurred under direct supervision of treating physician, the physician rated the response.~Ratings based on a 4 point scale; EXCELLENT - full relief of pain and cessation of objective signs of bleeding (swelling, tenderness, decrease in range of motion [for muscle bleeds]) within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.~GOOD - Substantial relief of pain and/or cessation of objective signs of bleeding within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.~MODERATE - slight relief of pain and slight improvement of signs of bleeding within 9 hours of treatment initiation. Requires additional infusion beyond treatment regimen.~NONE - No improvement or condition worsens. SUCCESSFUL = EXCELLENT or GOOD."|within 24 hours of infusion|Full Analysis Dataset|||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
1353110|NCT01757405|Primary|"Percentage of Bleeding Episode With Treatment Success"|No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen.|within 12 hours of first dose|Full Analysis Dataset|||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
1353111|NCT01757275|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days|FAS|||blood units|||Number
1353112|NCT01757275|Secondary|Number of Blood Units Transfused Within 72 Hours||within 72 hours|FAS|||blood units|||Number
1353113|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 30 Days||within 30 days|FAS|||participants|||Number
1353114|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 72 Hours||within 72 hours|FAS|||participants|||Number
1353115|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 30 Days||30 days|FAS|||participants|||Number
1353116|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 72 Hours||72 hours|FAS|||participants|||Number
1353117|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 30 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|30 days|FAS|||participants|||Number
1353118|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 7 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|7 days|FAS|||participants|||Number
1353119|NCT01757275|Primary|Rate of Clinically Significant Rebleeding Within 72 Hours|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy – initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|72 hours|Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS.|||participants|||Number
1353120|NCT01757197|Secondary|Effect of Toclizumab on Karnofsky Performance Status|We were unable to evaluate the effect of tocilizumab on Karnofsky Performance Status at 1 year. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|1 year|||||||
1353121|NCT01757197|Secondary|Toclizumab Response in Each Organ|We were unable to assess the Tocilizumab response in each organ at 1 year. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|1 year|||||||
1353122|NCT01757197|Secondary|Disease-free Overall Survival at 100 Days, 6 Months and One Year From the Time of the First Tocilizumab Infusion.|We were unable to evaluate disease-free survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|Approximately 1 year|We were unable to evaluate disease-free survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.||||||
1353123|NCT01757197|Primary|Number of Subjects With GVHD Who Are Tolerable to Tocilizumab After Having Failed Response to Glucocorticosteroid Treatment|Both subjects enrolled on this study experienced failed response to glucocorticosteroid treatment but were able to tolerate tocilizumab. We were unable to collect extensive data on these 2 subjects because they both died early on in the study due to disease complications.|Day 28|Not evaluable.|||Participants|||Count of Participants
1353124|NCT01757184|Secondary|Percentage Change From Baseline in Liver Volume|Relative reduction (percentage change from baseline) in liver volume, as assessed by magnetic resonance imaging, in the subset of subjects for whom imaging was performed|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an MRI assessment of liver volume at baseline and the last time point in the double-blind period.|||percentage change from baseline||Standard Deviation|Mean
1353125|NCT01757184|Secondary|Number of Subjects With Improvement in Liver Histology (Decrease of >5% in Hepatic Steatosis Score)|The number of subjects who had an improvement in hepatic histology (i.e., a decrease of >5% in hepatic steatosis score) from baseline to Week 20, as determined by blinded central review, in the subset of subjects for whom liver biopsy was performed.|Baseline to the end of the double-blind period (week 20)||||participants w/ improved liver histology|||Number
1353126|NCT01757184|Secondary|Percentage Change From Baseline in Liver Fat Content|Decrease in liver fat content, as assessed by magnetic resonance imaging (MRI), in the subset of subjects for whom imaging was performed|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an MRI assessment of liver fat content at baseline and the last time point in the double-blind period. (Note: liver fat content could only be determined for subjects able to breath-hold for 15-30 seconds, unlike liver volume.)|||percentage change from baseline||Standard Deviation|Mean
1353127|NCT01757184|Secondary|Percentage Change From Baseline in HDL-c|Relative increase (percentage change from baseline) in high density lipoprotein cholesterol (HDL-c) at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)||||percentage change from baseline||Standard Deviation|Mean
1353128|NCT01757184|Secondary|Percentage Change From Baseline in Triglycerides|Relative reduction (percentage change from baseline) in triglycerides at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)||||percentage change from baseline||Standard Deviation|Mean
1353129|NCT01757184|Secondary|Percentage of Subjects Achieving Aspartate Aminotransferase (AST) Normalization|The percentage of subjects with an abnormal baseline aspartate aminotransferase (AST; i.e., >ULN) who achieved AST normalization, based on age- and gender-specific normal ranges provided by the central laboratory performing the assay.|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an abnormal AST level at baseline. (One subject in the placebo group had a normal AST level at baseline and was therefore excluded from this analysis.)|||percentage of subjects|||Number
1353130|NCT01757184|Secondary|Percentage Change From Baseline in Non-HDL-c|Relative reduction (percentage change from baseline) in non-high density lipoprotein cholesterol (non-HDL-c) at the end of the double-blind period|Baseline to the end of the double-blind period (week 20)||||percentage change from baseline||Standard Deviation|Mean
1353131|NCT01757184|Secondary|Percentage Change From Baseline in LDL-c|Relative reduction (percentage change from baseline) in LDL-c at the end of the double-blind period.|Baseline to the end of the double-blind period (week 20)||||percentage change from baseline||Standard Deviation|Mean
1353132|NCT01757184|Primary|Percentage of Subjects Achieving Alanine Aminotransferase (ALT) Normalization|The primary efficacy endpoint was the percentage of subjects who achieve alanine aminotransferase (ALT) normalization (i.e., ALT below the age- and gender-specific upper limit of normal provided by the central laboratory performing the assay) at the end of the double-blind treatment period (i.e., the last double-blind assessment), relative to placebo.|Baseline to the end of the double-blind period (week 20)|All subjects in the Full Analysis Set (defined as subjects receiving at least one dose of study drug) who had an abnormal ALT level at baseline.|||percentage of subjects|||Number
1353133|NCT01757171|Secondary|Percent of Participants Treated With Cabazitaxel With Event Free Survival|To examine other measures of efficacy such as overall survival in all evaluable patients|From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||percentage of participants||95% Confidence Interval|Number
1353134|NCT01757171|Secondary|Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||participants|||Number
1353135|NCT01757171|Secondary|Duration of Event Free Survival of Subjects Treated With Cabazitaxel|To examine other measures of efficacy such as overall progression free in all evaluable patients|From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||months||95% Confidence Interval|Median
1353136|NCT01757171|Primary|Number of Participants With Progression at the 3 Month Follow up Visit|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Results below list the number of participants who progressed at the 3 month follow up visit|3 months||||participants|||Number
1353137|NCT01756976|Primary|Washed RBC Hematocrit|The Hematocrit of the RBC shall be > 50%.|< 4 hours||||percentage of HcT||Standard Deviation|Mean
1353138|NCT01756586|Primary|Increase in the Duration of Block||3 days|Did not have resources to follow up with the subjects after the surgery. The study was terminated early.||||||
1353187|NCT01756079|Primary|Percentage of Participants With One or More Adverse Events|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period|||Percentage of participants|||Number
1353139|NCT01756391|Primary|Maximum Symptom Days/14 Days|"Largest value among the following:~Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma"|14 days|Those with appropriate follow up and school/home allergen exposure data and allergy sensitization data|||days||Standard Deviation|Mean
1353140|NCT01756391|Secondary|Exhaled Nitric Oxide Levels||12 months|||||||
1353141|NCT01756391|Secondary|Percent Change in FEV1 After Short-acting Beta Agonist||12 months|||||||
1353142|NCT01756391|Secondary|FEV1 Percent Predicted||12 months|||||||
1353143|NCT01756391|Secondary|FEV1/FVC||12 months|||||||
1353144|NCT01756391|Secondary|Prednisone Bursts||12 months|||||||
1353145|NCT01756391|Secondary|Unscheduled Physician/Health Care Visits||12 months|||||||
1353146|NCT01756391|Secondary|Emergency Department Visits||12 months|||||||
1353147|NCT01756391|Secondary|Emergency Department Visits||12 months|||||||
1353148|NCT01756391|Secondary|Number of Hospitalizations||12 months|||||||
1353149|NCT01756391|Secondary|Nights of Wakening Due to Asthma Symptoms||12 months|||||||
1353150|NCT01756391|Secondary|Days of Cough Without an Upper Respiratory Infection||12 months|||||||
1353151|NCT01756391|Secondary|Days of Exercise-induced Symptoms||12 months|||||||
1353152|NCT01756391|Secondary|Days of Slowed Activity Due to Asthma||12 months|||||||
1353153|NCT01756300|Secondary|Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .|||percentage of participants|||Number
1353154|NCT01756300|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .|||percentage of participants|||Number
1353155|NCT01756300|Secondary|Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.|From baseline to 3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .|||mmHg||Standard Deviation|Mean
1353156|NCT01756300|Secondary|Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.|From baseline to 1 ,3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and radiofrequency (RF) energy is successfully applied in at least one artery. .|||mmHg||Standard Deviation|Mean
1353157|NCT01756300|Secondary|Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
1353158|NCT01756300|Primary|The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.|The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
1353175|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-D Scores|SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353159|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies in the Neonatal Intensive Care Unit (NICU) That Produced Meter Results Beyond What Random Chance Would Predict (i.e., Outside 95% Limits for Studentized Residuals)|To evaluate how the meter systems perform with blood samples drawn in the Neonatal Intensive Care Unit, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies in Neonatal Intensive Care was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis and, of these, thirty (30) blood samples were obtained from babies in the Neonatal Intensive Care Unit (NICU).|||BLOOD SAMPLES|BLOOD SAMPLES From Babies in the NICU||Number
1353160|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies Less Than 24 Hours Old That Produced Meter Results Beyond What Random Chance Would Predict (i.e. Outside 95% Limits for Studentized Residuals)|To evaluate the effect of neonatal age on the meter systems' performances, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies less than 24 hours old was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis. Of these, twenty five (25) blood samples were obtained from babies that were less than 24 hours old.|||BLOOD SAMPLES|BLOOD SAMPLES From Babies <24 hours old||Number
1353161|NCT01756274|Secondary|Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.|||percentage of BLOOD GLUCOSE RESULTS|BLOOD SAMPLES||Number
1353162|NCT01756274|Primary|Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.|||percentage of Blood Glucose Results|Blood Samples||Number
1353163|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Occupation|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353164|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Education|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353165|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Gender|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353166|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Age Categories|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353176|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-C Scores|SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353167|NCT01756235|Secondary|Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) and HAQ-DI Scores|The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Correlation coeficient|||Number
1353168|NCT01756235|Secondary|Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) and DAS28 Scores|The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Correlation coeficient|||Number
1353169|NCT01756235|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353170|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories’ SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS|This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353171|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories’ SQUASH Scores in Participants in Remission or LDAS|This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353172|NCT01756235|Secondary|Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)|LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
1353173|NCT01756235|Secondary|Percentage of Participants in Clinical Disease Remission (DAS28<2.6)|Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
1353174|NCT01756235|Secondary|Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score|The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353177|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-B Scores|SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353178|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-A Scores|SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353179|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Score|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6 and Month 9|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353180|NCT01756235|Primary|Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353181|NCT01756157|Secondary|Number of Angioedema Attacks Requiring Acute Treatment During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||angioedema attacks||Standard Deviation|Mean
1353182|NCT01756157|Secondary|Cumulative Symptomatic Days During the Treatment Period|Cumulative symptomatic days was defined as the sum of the symptomatic days of each angioedema attack reported during the treatment period. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. Cumulative symptomatic days was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||days||Standard Deviation|Mean
1353183|NCT01756157|Secondary|Cumulative Daily-severity During the Treatment Period|"Cumulative Daily-severity score was the sum of the severity scores recorded for every day of reported symptoms during the treatment period.~Severity scores were recorded as None=0, Mild=1, Moderate=2, and Severe=3. None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.~Cumulative daily severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.~The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||Score on a scale||Standard Deviation|Mean
1353184|NCT01756157|Secondary|Cumulative Attack-severity During the Treatment Period|"Cumulative Attack-severity score was the sum of maximum symptom severity recorded for each angioedema attack, determined on the last day of symptoms and recorded as None=0, Mild=1, Moderate=2, and Severe=3 and summing over the unique attacks, yields a Cumulative Attack-severity score.~None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.~Cumulative attack-severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.~The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||Score on a scale||Standard Deviation|Mean
1353185|NCT01756157|Primary|Normalized Number of Angioedema Attacks During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|Intent-to-treat efficacy (ITT-E) population included all participants who completed both randomized treatment periods and fulfilled a priori defined evaluability criteria.|||angioedema attacks||95% Confidence Interval|Mean
1353188|NCT01756079|Primary|Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.|Week 72 (24 weeks after end of treatment)|The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period.|||Percentage of participants||95% Confidence Interval|Number
1353189|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.~To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.~Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).~All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.~NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.|||Milliseconds||Standard Deviation|Mean
1353190|NCT01756053|Secondary|Effects of ABT-089 on Days of Biochemically-confirmed Abstinence|Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a ~4-day monitored abstinence phase within each period.|Days 7, 8, 9, 10, 38, 39, 40, & 41|Only participants completing both study periods (n=13) were included in the analyses.|||Days of abstinence||Standard Deviation|Mean
1353191|NCT01756053|Secondary|Effects of ABT-089 on Cigarette Ratings|Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 (“Not at all”) to 7 (“Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1353192|NCT01756053|Secondary|Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms|ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1353193|NCT01756053|Secondary|Effects of ABT-089 on Smoking Urges/Craving|QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1353194|NCT01756053|Secondary|Effects of ABT-089 on Withdrawal Symptoms|MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A “withdrawal discomfort score” was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1353195|NCT01756053|Secondary|Effects of ABT-089 on Mood|PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
1353196|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.~To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.~Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).~All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.~NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.|||Number of correct responses (out of 60)||Standard Deviation|Mean
1353197|NCT01755702|Secondary|Patients Global Assessment in Response to Treatment|Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.|Baseline to 8 weeks|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale|||Number
1353198|NCT01755702|Secondary|Headache Severity|"Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.~Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1353199|NCT01755702|Secondary|Number of Participants With Complete Headache Relief|Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of ‘no headache’ over total number of participants. These calculations were based on one headache per treatment per subject.|Baseline to 2 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Participants|||Number
1353200|NCT01755702|Secondary|Time to Rescue Medication|Time to rescue medication was evaluated.|Baseline to 6 hours post dose|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||minutes||Full Range|Median
1353201|NCT01755702|Secondary|Sum of TOTPAR and SPID (SPRID)|"Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:~SPRIDt = TOTPARt + SPIDt~TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1353202|NCT01755702|Secondary|Sum of Pain Intensity Difference (SPID)|"Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes – calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.~Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.~It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1353203|NCT01755702|Secondary|Total Pain Relief (TOTPAR)|"TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~It was calculated using the following formula.~TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1353204|NCT01755702|Secondary|Headache Relief Scores|Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1353205|NCT01755702|Primary|Time to First Perceptible Headache Relief|Time to first perceptible pain relief, calculated as time when partcipant selected ‘a little’ pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to ‘a little’ pain relief.|Baseline to 6 hours|Intention to treat (ITT) population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||minutes||Full Range|Median
1353206|NCT01755689|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|During the entire study period (from Month 0 to Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
1353207|NCT01755689|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Month 0 to Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
1353208|NCT01755689|Secondary|Number of Subjects With Serious Adverse Events SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
1353218|NCT01755689|Secondary|Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).|Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group]|The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.|||Participants|||Count of Participants
1353209|NCT01755689|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
1353210|NCT01755689|Secondary|Number of Subjects Reporting Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for “Dose 2” because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
1353211|NCT01755689|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for “Dose 2” because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
1353212|NCT01755689|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value|The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL.|Prior to and one month after Boostrix vaccination (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
1353213|NCT01755689|Secondary|Anti-D and Anti-T Antibody Concentrations|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to and one month after Boostrix vaccination (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||IU/mL||95% Confidence Interval|Geometric Mean
1353214|NCT01755689|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to and one month after Boostrix vaccination (Month 0 and Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
1353215|NCT01755689|Secondary|Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies|"Booster responses to the PT, FHA and PRN antigens were defined as:~For initially seronegative subjects (antibody concentrations: < 2.046 IU/ml for anti-FHA, < 2.187 IU/ml for anti-PRN, < 2.693 IU/ml for anti-PT), antibody concentration ≥ 4*cut_off IU/ml at Month 1 post-vaccination;~For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration < 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration;~For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration."|At one month after Boostrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
1353216|NCT01755689|Secondary|Anti-HPV-16 and Anti-HPV-18 Concentrations|The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.|Prior to and one month after the third dose of Cervarix (Months 0 and 8)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination from the Nimenrix+Cervarix (1,2,7-Month) Group.|||EU/mL||95% Confidence Interval|Geometric Mean
1353217|NCT01755689|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL.|Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8)|The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.|||Participants|||Count of Participants
1353219|NCT01755689|Secondary|Anti-T Antibody Concentrations|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group.|Prior to and one month after vaccination with Nimenrix (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.|||IU/mL||95% Confidence Interval|Geometric Mean
1353220|NCT01755689|Secondary|Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL|The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.|Prior to and one month after vaccination with Nimenrix (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.|||Participants|||Count of Participants
1353221|NCT01755689|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response|"rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:~For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination.~For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination."|At one month after Nimenrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.|||Participants|||Count of Participants
1353222|NCT01755689|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128|The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine.|Prior to and one month after vaccination with Nimenrix (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.|||Participants|||Count of Participants
1353223|NCT01755689|Primary|Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.|At one month after Boostrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||IU/mL||95% Confidence Interval|Geometric Mean
1353224|NCT01755689|Primary|Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.|At one month after Boostrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
1353225|NCT01755689|Primary|Anti-HPV-16 and Anti-HPV-18 Concentrations|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).|At one month after vaccination with Cervarix (Month 7)|The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
1353226|NCT01755689|Primary|Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)|The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.|At one month after vaccination with Nimenrix (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.|||Titers||95% Confidence Interval|Geometric Mean
1353227|NCT01755637|Secondary|Cmax of Active Metabolite - Albendazole Sulphoxide|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||ng/mL||Standard Deviation|Mean
1353228|NCT01755637|Secondary|AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide|AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.|||ng.hr/mL||Standard Deviation|Mean
1353229|NCT01755637|Secondary|AUC (0-t) of Active Metabolite - Albendazole Sulphoxide|AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.|||ng.hr/mL||Standard Deviation|Mean
1353230|NCT01755637|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole|Tmax was time at which Cmax of Albendazole was reached.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.|||hr||Full Range|Median
1353231|NCT01755637|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||ng/mL||Standard Deviation|Mean
1353232|NCT01755637|Primary|AUC [0-infinity (Inf)] of Albendazole|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||ng.hr/mL||Standard Deviation|Mean
1353233|NCT01755637|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.|AUC (0-t) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||nanogram (ng).hr per milliliter (mL)||Standard Deviation|Mean
1353234|NCT01755455|Secondary|Change From Baseline in Sputum Iron (ng/mg)||Baseline and 6 weeks||||ng/mg||Standard Error|Mean
1353235|NCT01755455|Secondary|Change From Baseline in Transferrin Saturation (%)||Baseline and 6 weeks||||% saturation||Standard Error|Mean
1353236|NCT01755455|Secondary|Change From Baseline in Serum Iron (mcg/dl)||Baseline and 6 weeks||||mcg/dl||Standard Error|Mean
1353237|NCT01755455|Primary|Change From Baseline in Hemoglobin Concentration (gm/dl)||Baseline and 6 weeks||||gm/dl||Standard Error|Mean
1353238|NCT01755416|Primary|Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone|Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)|0-1500 min||||mg/dl||Standard Deviation|Mean
1353239|NCT01755234|Secondary|Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.|Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.|Discharge from PACU to 24 hours post operative after PACU discharge.||||mg morphine equivalents||Inter-Quartile Range|Median
1353240|NCT01755234|Secondary|Pain in Post Anesthesia Care Unit|"Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain and time in the Post Anesthesia Care Unit.~The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC."|Time in the post anesthesia care unit||||Pain Score * minutes in PACU||Inter-Quartile Range|Median
1353241|NCT01755234|Secondary|Mg of Morphine Equivalents (IV)|Total opioid use in the post operative care unit (Mg of morphine equivalents)|PACU admission to discharge||||miligrams of morphine equivalents||Inter-Quartile Range|Median
1353242|NCT01755234|Primary|Quality of Recovery Score 24 Hours Post Operative|Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.|24 hours after the surgical procedure||||units on a scale||Inter-Quartile Range|Median
1353243|NCT01755169|Primary|Number of Participants With Dose Limiting Toxicity|A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.|2 weeks||||Participants|||Count of Participants
1353244|NCT01755156|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B)|Data presented are a cumulative incidence of participants with glycemic rescue by Week 104.|Up to 104 weeks|All participants randomized population.|||Percentage of participants|||Number
1353245|NCT01755156|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A)|Data presented are a cumulative incidence of participants with glycemic rescue by Week 24.|Up to 24 weeks|All participants randomized population.|||Percentage of participants|||Number
1353246|NCT01755156|Secondary|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B)|Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued.|Up to 104 weeks|All participants randomized population.|||Percentage of participants||95% Confidence Interval|Number
1353247|NCT01755156|Secondary|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A)|Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride.|Up to 24 weeks|All participants randomized population.|||Percentage of participants||95% Confidence Interval|Number
1353248|NCT01755156|Secondary|Change From Baseline in Fasting Insulin at Week 104 (Phase A+B)|Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||μIU/mL||95% Confidence Interval|Least Squares Mean
1353279|NCT01754987|Primary|Number of Participants That Experience Serious Adverse Events.|The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0|16 weeks +/- 2 weeks|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
1353249|NCT01755156|Secondary|Change From Baseline in Fasting Insulin at Week 24 (Phase A)|Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||micro International Unit (μIU)/mL||95% Confidence Interval|Least Squares Mean
1353250|NCT01755156|Secondary|Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A)|Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg*h/dL||95% Confidence Interval|Least Squares Mean
1353251|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B)|Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.|104 weeks|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1353252|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B)|Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.|104 weeks|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1353253|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A)|Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.|24 weeks|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Number
1353254|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A)|Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.|24 weeks|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Number
1353255|NCT01755156|Secondary|Change From Baseline in FPG at Week 104 (Phase A+B)|Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1353256|NCT01755156|Secondary|Change From Baseline in A1C at Week 104 (Phase A+B)|A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
1353257|NCT01755156|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A)|Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1353258|NCT01755156|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A)|Change from baseline in 2-hour PMG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1353259|NCT01755156|Primary|Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B)|The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs.|Up to 104 weeks|All participants as treated population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
1353260|NCT01755156|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 104 weeks|All participants as treated population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
1353261|NCT01755156|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 107 weeks|All participants as treated population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
1353262|NCT01755156|Primary|Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A)|A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
1353263|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period||||participants|||Number
1353264|NCT01755143|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee|During MRI scans (9-12 weeks post-implant)||||participants|||Number
1353265|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.|||participants|||Number
1353266|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period||||participants|||Number
1353267|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.|||participants|||Number
1353268|NCT01755143|Primary|MRI-related Complication Free Rate|Number of patients free of MRI-related complications|MRI scan to one month later|Patients who underwent an MRI|||participants|||Number
1353269|NCT01755091|Secondary|Change in Desaturation Time (DT)|Change in DT (total minutes with arterial oxygen saturation below 85% during 8-hour polysomnography) derived as: DT (end of treatment) minus DT (pre-treatment)|6 weeks||||minutes||Standard Deviation|Mean
1353270|NCT01755091|Secondary|Adverse Events (AEs)|AEs will be evaluated and tracked throughout subject participation (up to 8 weeks)|Up to 8 weeks||||Number of adverse events per participant||Standard Deviation|Mean
1353271|NCT01755091|Secondary|Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.|"The TSQM measures a person's satisfaction with treatment based on a 7-point scale ranging from Extremely Dissatisfied to Extremely Satisfied in response to the question, Taking all things into account, how satisfied or dissatisfied are you with this medication?."|Week 6|Data are missing for one participant randomized to receive Placebo treatment due to technical error in not collecting the instrument.|||Participants|||Count of Participants
1353272|NCT01755091|Primary|Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)|Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time.|Baseline and Week 6||||minutes||Standard Deviation|Mean
1353273|NCT01755091|Primary|Change in Epworth Sleepiness Scale (ESS)|Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales.|Baseline and Week 6|Data are missing for 2 participants randomized to receive Placebo treatment; due to technical error in not completing this instrument.|||units on a scale||Standard Deviation|Mean
1353274|NCT01755091|Primary|Change in Apnea/Hypopnea Index (AHI)|Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)|Baseline and Week 6|Analysis performed including all participants who completed the full 6-weeks of treatment.|||events/hour||Standard Deviation|Mean
1353275|NCT01755026|Primary|Cefazolin Levels|Cefazolin levels|2 hours||||mcg/mL||Standard Error|Mean
1353276|NCT01754987|Secondary|Number of Participants That Are Alive After 15 Weeks of Treatment.|To evaluate duration of tumor response and progression-free survival|15 weeks+|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
1353277|NCT01754987|Secondary|Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument|To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G will be summarized at multiple time points. Five-point scale from 0 (not at all) to 4 (very much)|16 weeks +/- 2 weeks|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
1353278|NCT01754987|Secondary|Overall Tumor Response Rate|To utilize CT or PET/CT scans to assess overall tumor response rate (complete) in subjects with advanced metastatic hepatocellular cancer treated with the combination of ascorbic acid and sorafenib versus sorafenib alone.|16 weeks +/- 2 weeks|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
1353281|NCT01754922|Primary|VO2 Peak|Maximal oxygen consumption measured during exercise|At peak exercise; cross-sectional|4 participants were excluded due to failure to meet maximal exercise criteria (3 from exposed, 1 from control). Therefore, we removed these individuals from the final analysis.|||ml/min/kg||Standard Deviation|Mean
1353282|NCT01754922|Primary|FEV1|Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge|Pre/post exercise; cross-sectional||||percentage of predicted normal values||Standard Deviation|Mean
1353283|NCT01754766|Secondary|Conjunctival Hyperemia Score|Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point|||Score on a scale||Standard Deviation|Mean
1353284|NCT01754766|Secondary|Ocular Itching Score at Day 15|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 15|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point|||Score on a scale||Standard Deviation|Mean
1353285|NCT01754766|Primary|Ocular Itching Score at Day 1|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point|||Score on a scale||Standard Deviation|Mean
1353286|NCT01754727|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353287|NCT01754727|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353288|NCT01754727|Secondary|Mean Change From Baseline in BASDAI Score|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).|Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
1353289|NCT01754727|Secondary|Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider|Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Number of visits||Standard Deviation|Mean
1353290|NCT01754727|Secondary|Mean Change in the Number of Sick Leaves|Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only).|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Number of sick leaves||Standard Deviation|Mean
1353291|NCT01754727|Secondary|Mean Change in the Number of Sick Leave Days|Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Days||Standard Deviation|Mean
1353292|NCT01754727|Secondary|Mean Change in the Number of Hospitalizations|Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Number of admissions to hospital||Standard Deviation|Mean
1353293|NCT01754727|Secondary|Mean Change in the Number of Hospital Inpatient Days|Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Days||Standard Deviation|Mean
1353350|NCT01754389|Secondary|Percentage of Participants With Non-relapse Mortality|Non-relapse mortality by 1 year after stem cell infusion.|1 year||||Percentage of participants||95% Confidence Interval|Number
1353294|NCT01754727|Secondary|Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
1353295|NCT01754727|Secondary|Percentage of Participants Achieving BASDAI 50|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline.|Month 3, Month 6 and Month 9|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
1353296|NCT01754727|Primary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.|Month 0 (baseline) and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
1353297|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|ALT/AST ratio|change from baseline at 6 weeks||||Ratio||Standard Deviation|Mean
1353298|NCT01754714|Secondary|Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*||||mcg/mL||Standard Deviation|Mean
1353299|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Hyaluronic acid|change from baseline at 6 weeks||||ng/mL||Standard Deviation|Mean
1353300|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Caspase-cleaved cytokeratin (CK 18)|change from baseline at 6 weeks||||U/L||Standard Deviation|Mean
1353301|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|oxidative stress marker (isoprostane level)|change from baseline at 6 weeks||||ng/mg Crea||Standard Deviation|Mean
1353302|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|glutathione in erythrocytes|change from baseline at 6 weeks||||mcmol/g||Standard Deviation|Mean
1353303|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|C-reactive Protein (CRP)|change from baseline at 6 weeks||||nmol/L||Standard Deviation|Mean
1353304|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Adiponectin|change from baseline at 6 weeks||||mcg/mL||Standard Deviation|Mean
1353305|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|glycosylated hemoglobin (HbA1c)|change from baseline at 6 weeks||||Percentage||Standard Deviation|Mean
1353306|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting plasma insulin|Change from baseline at 6 weeks||||pmol/L||Standard Deviation|Mean
1353307|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Time to peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||minutes||Inter-Quartile Range|Median
1353308|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||Atom %C13||Standard Deviation|Mean
1353309|NCT01754714|Secondary|Methionine Volume of Distribution at Week 7 (L)|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||L||Standard Deviation|Mean
1353310|NCT01754714|Secondary|The Metabolic Clearance Rate Measured in the Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||L/h||Standard Deviation|Mean
1353311|NCT01754714|Other Pre-specified|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|"Non-invasive test for liver disease (ActiTest)/Fibrotest~FibroTest® : diagnoses hepatic fibrosis ActiTest® : assesses viral necro-inflammatory activity Scores between 0 and 1, the higher the score the worse~The FibroTest score is calculated from the results of a six-parameter blood test, combining six serum markers with the age and gender of the patient:Alpha-2-macroglobulin, Haptoglobin, Apolipoprotein A1, Gamma-glutamyl transpeptidase (GGT), Total bilirubin, and Alanine transaminase (ALT). ALT is used in a second assessment called ActiTest that is part of FibroTest."|change from baseline at 6 weeks||||scores on a scale||Standard Deviation|Mean
1353312|NCT01754714|Other Pre-specified|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|Cytokine profile ( Interleukin-6, IL-8, IL-10 (IL), Tumor Necrosis Factor (TNF -α), monocyte chemoattractant protein (MCP-1), and Granulocyte-colony stimulating factor (G-CSF ).|change from baseline at 6 weeks||||pg/mL||Standard Deviation|Mean
1353313|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.|change from baseline at 6 weeks||||mmol/L||Standard Deviation|Mean
1353314|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)|change from baseline at 6 weeks||||U/L||Standard Deviation|Mean
1353315|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||percentage of recovery||Standard Deviation|Mean
1353316|NCT01754714|Secondary|Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||mcg/mL||Standard Deviation|Mean
1353317|NCT01754714|Primary|Methionine Elimination Half-life Measured in Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||hour||Standard Deviation|Mean
1353318|NCT01754623|Secondary|Overall Survival (OS) Rate|OS at time of analysis, calculated from date of enrollment to date of death from any cause.|12 months|All participants per group|||percentage of participants|||Number
1353319|NCT01754623|Secondary|Progression-Free Survival (PFS) at Three Years|PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.|3 years|Evaluable participants at 3 years.||||||
1353320|NCT01754623|Primary|Margin-negative (R0) Resection Rate|R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.|Up to 3 years|All participants with resection|||percentage of participants|||Number
1353321|NCT01754519|Secondary|Disease Specific Survival|The disease specific survival will be analyzed using Kaplan-Meier method.|Up to 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
1353322|NCT01754519|Secondary|Overall Survival|The overall survival will be analyzed using Kaplan-Meier method.|Up to 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
1353323|NCT01754519|Secondary|Locoregional Control Rate|Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.|At 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
1353324|NCT01754519|Primary|Cosmetic Differences in the Treated Breast|Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.|Up to 2 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
1353325|NCT01754519|Primary|Quality-of-life Assessments|Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.|Up to 2 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
1353326|NCT01754519|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.|Up to 2 years|All treated and eligible patients|||Participants|||Count of Participants
1353327|NCT01754493|Secondary|Somatization Module of the Patient's Health Questionnaire (PHQ-15)|Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
1353328|NCT01754493|Secondary|Visual Analogue Scales (VAS)|Five self-report 11-point Likert scales measuring pain severity in the following domains (one item each): overall pain, pain interfering with daily activities, headaches, back pain, and shoulder pain. Range is 0-10; higher scores indicate higher pain severity.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
1353329|NCT01754493|Secondary|Clinician-Rated Global Impression Scales (CGI)|Two clinician-administered scales measuring level of change in (1) depressive symptoms and (2) IBS symptoms, assessed separately. Range is 1-7, ranging from very much improved (1) to very much worsened (7).|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
1353330|NCT01754493|Primary|Gastrointestinal Symptoms Rating Scale (GSRS)|Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
1353331|NCT01754493|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
1353506|NCT01751971|Secondary|Subjective Sleepiness/Alertness (Stanford Sleepiness Scale)|Assessed in the morning after the single night of treatment. Minimum score: 1 (alert), maximum score: 7 (not alert).|1 night|Patients with AHI>20|||Scores on a scale||Standard Error|Mean
1353332|NCT01754480|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||percent of subjects|||Number
1353333|NCT01754480|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:~At 2 minutes following start of study treatment~At 5 minutes following start of study treatment~At 7 minutes following start of study treatment~At 10 minutes following start of study treatment"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
1353334|NCT01754480|Secondary|Time to Hemostasis|Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||minutes||95% Confidence Interval|Median
1353335|NCT01754480|Secondary|Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 3 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
1353336|NCT01754480|Primary|Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
1353337|NCT01754467|Secondary|Changes in Total Sedentary Time|Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month|Baseline and 1 month|One individual outlier showed opposite changes as compared with the other participants and was 2.1 standard deviations above the mean for change in percent of day spent in sedentary behavior; thus this individual was excluded from this analysis.|||percentage of day spent sedentary||Standard Deviation|Mean
1353338|NCT01754467|Secondary|Breaks in Sedentary Behavior|Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month|Baseline and 1 month||||breaks/day||Standard Deviation|Mean
1353339|NCT01754467|Secondary|Adherence to NEAT!|NEAT usage (days/month)|1 Month||||days||Standard Deviation|Mean
1353340|NCT01754467|Primary|Acceptability of NEAT!|How many participants would continue to use or use NEAT! in the future|1 month||||Participants|||Count of Participants
1353341|NCT01754402|Secondary|Progression Free Survival|The time elapsed for patients between initiation of study therapy and either disease progression or death|up to 2 years|||||||
1353342|NCT01754402|Secondary|Time to Next Therapy|Time to next Therapy - defined as the time elapsed for patients from initiation of study therapy until initiation of next therapy|up to 2 years|||||||
1353343|NCT01754402|Secondary|Time to Progression|Time to progression - defined as time elapsed in patients between achievement of response and disease progression|up to 2 years|||||||
1353344|NCT01754402|Secondary|Overall Response Rate|"The number of patients achieving stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR)~sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h~SD = Not meeting criteria for CR, VGPR, PR, or progressive disease"|up to 2 years|||||||
1353345|NCT01754402|Primary|Initial Response Rate|"The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as:~CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow~PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required~VGPR - Serum and urine M-protein detectable by immunofixation but n"|2 cycles (approximately 2 months)|The overall number of participants analyzed reflects those who received at least 2 cycles of treatment. These participants were assessed for response at that time. The data reported indicates how many patients out of each cohort experienced at least a partial response or complete response.|||Participants|||Count of Participants
1353346|NCT01754402|Primary|Maximum Tolerated Dose of Pomalidomide and Bendamustine|"In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached.~Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg)~If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD)."|2 cycles (approximately 2 months)|All patients enrolled in cohort 1 and 2 evaluable for DLT. Cohorts 3 and 4 were not evaluated due to both patients in Cohort 2 experiencing DLT.|||milligrams|||Number
1353347|NCT01754389|Secondary|Percentage of Participants With Chronic Graft Versus Host Disease|Rates of chronic GVHD 1 year after stem cell infusion|1 year||||Percentage of participants|||Number
1353348|NCT01754389|Secondary|Percentage of Participants With Progression-free and Overall Survival|Progression-free and overall survival 1 year post stem cell infusion|1 year||||Percentage of participants|||Number
1353349|NCT01754389|Secondary|Percentage of Participants With Relapse|Relapse relapse-cum-immunosuppression-free survival at 1 year after stem cell infusion|1 year||||Percentage of participants||95% Confidence Interval|Number
1353351|NCT01754389|Primary|Percentage of Participants With Incidence of Grade II-IV GVHD|The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 180 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.|6 months||||Percentage of participants||95% Confidence Interval|Number
1353352|NCT01754376|Secondary|Ratio of CD8+ T Cells to Regulatory T Cells|Tumor samples were collected pre-treatment, after 1-2 weeks on vemurafenib alone and after administration of aldesleukin (high-dose interleukin 2, HD-IL2). Multi-parameter flow cytometry was performed to measure the frequency of regulatory T cells and of CD8+ T cells. The CD8/Treg ratio was calculated.|Up to 8 weeks from start of treatment|Tumor tissue was only analyzed from one participant|||ratio CD8/T reg cells|||Number
1353353|NCT01754376|Secondary|Mean Percentage of Aldesleukin Doses Received Per Participant|To assess whether the number of doses of aldesleukin that can be safely administered is affected by the co-administration of vemurafenib. The total number of planned doses of aldesleukin was 28 in each of course 1 and course 2. A participant receiving all 28 doses in course 1 would be considered as receiving 100 percent of doses.|Approximately 9 months from start of treatment|Six participants started course 1. Only 4 participants started course 2.|||percentage of doses||Full Range|Mean
1353354|NCT01754376|Secondary|Number of Participants Experiencing Grade 3 (Severe) Adverse Events|To determine the toxicity and safety of concurrent administration of aldesleukin and vemurafenib by assessing adverse events experienced by participants.|2 years||||Participants|||Count of Participants
1353355|NCT01754376|Secondary|Overall Survival|To determine the overall survival in patients treated with aldesleukin and vemurafenib. Overall survival is defined as the time between the first administration of study drug and death due to any cause.|2 years|Median overall survival was not reached|||months||Full Range|Median
1353356|NCT01754376|Secondary|Overall Response Rate|To determine the overall response rate (as defined as the rate of objective response (Complete Response (CR) or Partial Response (PR)) lasting continuously for 12 or more months, and beginning at any point within 12 months of initiating therapy) in patients treated with aldesleukin and vemurafenib. In this limited cohort, response rate was calculated as the proportion of patients with partial (PR) or complete response (CR) divided by the total number of patients treated. Per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), 'Complete Response' is the disappearance of all target lesions and 'Partial Response' is at least a 30% decrease in the sum of the diameters of target lesions, as measured via CT (computed tomography). Overally Response (OR) = CR + PR.|2 years||||percentage of participants||95% Confidence Interval|Number
1353357|NCT01754376|Primary|Progression Free Survival|To assess the efficacy (as measured by progression-free survival (PFS)) of patients with metastatic melanoma with V600E mutation treated with the combination of vemurafenib and aldesleukin. Progression free survival is defined as the time between the first dose of study drug and the first occurrence of progression of disease or death from any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.|3 years||||weeks||95% Confidence Interval|Median
1353358|NCT01754259|Secondary|Change in LV Diastolic Function|Change (from baseline) in LV diastolic function reflected primarily in mitral annular early diastolic relaxation velocity (E’) at 4 weeks post randomization. LV end-diastolic and end-systolic volumes (used to calculate LVEF), left atrial volume, septal and lateral peak early diastolic tissue velocity (e′), septal and lateral peak systolic tissue velocity (s′), and mitral inflow velocity (E) were all measured in accordance with ASE guidelines.|4 weeks||||% change|||Number
1353359|NCT01754259|Primary|Change in Post-exercise Coronary Vasodilator Reserve|Change (from baseline) in post-exercise coronary vasodilator reserve, as measured by PET imaging at 4 weeks post randomization. Per-patient global coronary flow reserve (CFR) was calculated as the ratio of absolute MBF at stress over rest for the entire left ventricle. Quantitation of MBF was performed by two operators blinded to patient, treatment period and treatment order.|4 weeks||||% change|||Number
1353360|NCT01754194|Secondary|Surgical Complications|Incidence of procedural and post-procedural complications through 30 days post-op.|30 Days||||participants|||Number
1353361|NCT01754194|Secondary|Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization||12 Months||||percentage of patients|||Number
1353362|NCT01754194|Secondary|Health Resource Utilization - Recovery Time From Surgery||12 months||||Days||Standard Deviation|Mean
1353363|NCT01754194|Secondary|Health Resource Utilization - Durantion of Sugery||12 Months||||Minutes||Standard Deviation|Mean
1353364|NCT01754194|Secondary|Excess Weight Loss (EWL)|"EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss.~The formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight [lbs] – IBW [lbs]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the more the patient lost weight."|12 Months||||Percentage EWL*month||Standard Deviation|Mean
1353365|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)|The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.|12 months||||Score*months||Standard Deviation|Mean
1353366|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)|The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.|12 months||||Score*months||Standard Deviation|Mean
1353367|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)|The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.|12 Months||||Score*months||Standard Deviation|Mean
1353368|NCT01754129|Secondary|DUODOPA Total Daily Infusion Dosage|The total daily DUODOPA infusion dosage was documented at study visits starting at the baseline visit. One mL of DUODOPA contains 20 mg levodopa and 5 mg carbidopa monohydrate.|Baseline, Visit 1, Visit 2, (Year 1) and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||mL||Standard Deviation|Mean
1353369|NCT01754129|Secondary|Participant Self-assessment Scale of DUODOPA Therapy|Participants were asked to rate DUODOPA therapy on a scale from 0 to 10 (0-2 worse, 3-5, unsatisfactory, 6-8 satisfactory, 9-10, very good).|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||units on a scale||Standard Deviation|Mean
1353370|NCT01754129|Secondary|Change in Global Effectiveness on Motor Symptoms as Compared to Baseline|Motor symptoms were rated by neurologists using three categories: improvement, no change, or worsening as compared to symptoms present at baseline.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||Participants|||Count of Participants
1353371|NCT01754129|Secondary|Concomitant Diseases and Medications|Concomitant diseases were coded using the MedDRA dictionary (version 15.1). Concomitant diseases present in ≥ 5% of participants started before or at Visit 1 and stopped after Visit 1 or ongoing or started after Visit 1 are presented. Non-PD medications in ≥ 5% of participants maintained with a start date previous to the date of Visit 1 and a stop date after date of Visit 1 or ongoing are listed.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|All enrolled participants from the screened population with all inclusion/exclusion criteria met|||Participants|||Count of Participants
1353372|NCT01754129|Secondary|Change in Relative Stress Scale (RSS) Scores|The Relative Stress Scale is a 15-item questionnaire completed by family caregivers to assess personal distress, life upset, and negative feelings regarding caring for a family member with PD. Scores on each item range from 1 (not at all) to 5 (to a high degree). The RSS total score ranges from 15 (low stress) to 75 (severe stress). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353373|NCT01754129|Secondary|Economic and Social Impact of Family-provided Healthcare|Family caregivers were surveyed regarding the participant’s need for home health care for Parkinson's Disease; the amount of time dedicated to care each week; the need of a family caregiver to reduce or change their normal work hours in order to provide care; the number of working days per month spent performing caregiver responsibilities; the number of hours of professional assistance per week needed; and the hourly costs of professional assistance incurred per week.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||hours||Standard Deviation|Mean
1353374|NCT01754129|Secondary|Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Scores|The Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease-Rating Scale is a 28-item survey used to assess the frequency and severity of behaviors including gambling, sexual behavior, buying, eating, performing tasks or hobbies, repeating simple activities, and PD medication use. Scores on each item range from 0 (never) to 4 (very often). The QUIP-RS total score ranges from 0 (normal function) to 112 (severely impaired function). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353375|NCT01754129|Secondary|Change in Gait and Falls Questionnaire (GFQ) Scores|The Gait and Falls questionnaire (GFQ) is a self-administered 16-item questionnaire addressing gait in daily living, the frequency and severity of freezing of gait, the frequency of festinating gait and its relation to falls, and the frequency and severity of falls. Scores on each item range from 0 (no symptoms) to 4 (severe symptoms). The GFQ total score ranges from 0 (normal function) to 64 (severely impaired function). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353376|NCT01754129|Secondary|Change in Parkinson’s Disease Sleep Scale Version 2 (PDSS-2) Scores|The Parkinson’s Disease Sleep Scale version 2 (PDSS-2) is a self-administered 15-item questionnaire addressing sleep and nocturnal disturbances in PD, including sleep quality, difficulty falling and staying asleep, restlessness, pain, or muscle cramps in legs or arms, dreams or hallucinations, getting up at night to pass urine, immobility at night, painful posturing in the morning, tremor on waking, sleepiness upon waking, and snoring or breathing difficulties. Scores on each item range from 0 (never) to 4 (very frequent). The PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353377|NCT01754129|Secondary|Change in Parkinson’s Disease Quality of Life Questionnaire (PDQ-39) Scores|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in PD. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The total score is between 0 and 156, calculated as the total sum of the items, and higher scores are associated with more severe symptoms. Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353378|NCT01754129|Secondary|Change in Unified Parkinson’s Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases|The UPDRS is an Investigator-used rating tool to follow the course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0 to 16 and higher scores are associated with more disability. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. Scores for both “On” time (when PD symptoms are well-controlled by the drug) and “Off” time (when PD symptoms are not adequately controlled by the drug) are presented. Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353379|NCT01754129|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3|"The UPDRS is an Investigator-used rating tool to follow the course of Parkinson's disease. Scores for dyskinesias, early-morning dystonia, and clinical fluctuations (off times when PD symptoms are not adequately controlled by the drug) were assessed by the sum of the Part A+B items, questions 32-39. Questions 32-34 and 39 are measured on a 5-point scale (0-4), with 0 being no disease and 4 representing severe disease. Higher scores indicate a greater duration of dyskinesia (Q32), disability (Q33), and pain (Q34), and proportion of the waking day spent in off (Q39). Questions 35-38 are scored on a binary scale where 0= no and 1=yes, with higher scores indicating a higher incidence of early morning dystonia, and a higher degree of clinical fluctuations. The total score ranges from 0 (normal) to 20 (severe disease). Negative changes from baseline indicate improvement."|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353380|NCT01754129|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in “Off”) Score: Mean Change From Baseline to the Last Available Follow up|"Section B of the UPDRS IV questionnaire consists of 4 individual items that assess the degree of clinical fluctuations. Item 39 is the percentage of off times (when PD symptoms are not adequately controlled by the drug) during the waking day. The Item 39 score ranges from 0 (None), 1 (1– 25% of the waking day), 2 (26 – 50% of the waking day), 3 (51 – 75% of the waking day), and 4 (76 – 100% of the waking day). The mean change from baseline was calculated as the score at the last available follow up visit minus the score at baseline/Visit 1. Negative change from baseline for off time indicates improvement."|Baseline/Visit 1 and Visit 2 (Year 1) or Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
1353381|NCT01753999|Secondary|CPAP Efficacy|Efficacy will be evaluated by measuring change in the apnea and hypopnea index (AHI) between the end of treatment and baseline. The efficacy of standard CPAP and CPAP flex will be compared. Results are based on the first treatment period only (pre-crossover).|9 weeks after initiation of treatment|Subjects who received and used the PAP device.In addition to subjects excluded from analysis in the adherence outcome, an additional 49 subjects in CPAP and 53 in CFLex were not analyzed as an AHI could not be generated during the analysis period due to insufficient use during this period.|||Events/hour||Standard Deviation|Mean
1353382|NCT01753999|Primary|Adherence to CPAP|The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on the first treatment period only (pre-crossover).|9 weeks after initiation of treatment|Subjects who received the allocated treatment (i.e., turned on the PAP device). The difference between the number allocated and the number of analyzed is the result of some subjects (n=11 in CPAP and n=16 in C-Flex) who did not turn on the device despite taking it home. These were assumed to have NOT received the allocated treatment.|||Hours/night||Inter-Quartile Range|Median
1353383|NCT01753856|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the CC, EC and IC of the Iliac Crest|ES/BS is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption. Percentage = (ES/BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with ES/BS assessed in the CC, EC and IC of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
1353563|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|3 years|||||||
1353384|NCT01753856|Secondary|Wall Thickness (W.Th) in the CC, EC and IC of the Iliac Crest|W.Th is the distance from the cement line to the marrow space of completed trabecular bone packets.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with a W. Th assessment in the CC, EC and IC of the iliac crest.|||µm||Inter-Quartile Range|Median
1353385|NCT01753856|Other Pre-specified|Average Length of DLs in the CC, EC, IC and PC of the Iliac Crest|The length of TET DLs is a measure of the extent of bone formation in each compartment within individual remodeling units and is measured in mm. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of DL length in the various compartments of the iliac crest.|||mm||Standard Deviation|Mean
1353386|NCT01753856|Secondary|Osteoid Thickness (O.Th) in the CC, EC and IC of the Iliac Crest|O.Th is a measure of the average thickness of osteoid seams.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an O.Th assessment in the CC, EC and IC of the iliac crest.|||micrometers (mcm)||Inter-Quartile Range|Median
1353387|NCT01753856|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the CC, EC and IC of the Iliac Crest|OS is the percentage of the entire trabecular BS that is covered by osteoid. Percentage = (OS / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the assessment of OS/BS in the CC, EC and IC of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
1353388|NCT01753856|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the CC of the Iliac Crest|OV is the percentage of a given volume of bone tissue that consists of new unmineralized bone matrix (osteoid). Percentage = (OV/BV) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of OV/BV in the CC of the iliac crest.|||percentage of BV||Inter-Quartile Range|Median
1353389|NCT01753856|Secondary|Adjusted Apposition Rate (Aj.AR) in the CC, EC and IC of the Iliac Crest|Aj.AR is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were counted as missing.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Aj.AR assessments in the CC, EC and IC of the iliac crest.|||µm/day||Inter-Quartile Range|Median
1353390|NCT01753856|Secondary|Activation Frequency (Ac.f) in the CC, EC and IC of the Iliac Crest|Ac.f is the probability of new remodeling cycles initiated on the BS per year. Ac.f = (BFR/BS) / wall thickness. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were assigned a value of zero.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Ac.f assessments in the CC, EC and IC of the iliac crest.|||new cycles per year||Inter-Quartile Range|Median
1353391|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX)|CTX is a marker of bone turnover and is a measure of bone resorption. Percentage = (CTX value at specified time points - CTX value at baseline) / (CTX value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and serum CTX measured at baseline and the specified time points.|||percentage change in CTX||Inter-Quartile Range|Median
1353392|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Osteocalcin|Osteocalcin is a marker of bone turnover and a measure of osteoblast function. Percentage = (osteocalcin value at specified time points - osteocalcin value at baseline) / (osteocalcin value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum osteocalcin measured at baseline and the specified time points.|||percentage change in osteocalcin||Inter-Quartile Range|Median
1353393|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Procollagen Type I N-terminal Propeptide (P1NP)|P1NP is a marker of bone turnover and is a measure of bone formation. Percentage = (P1NP value at specified time points - P1NP value at baseline) / P1NP value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum P1NP measurements at baseline and the specified time points.|||percentage change in P1NP||Inter-Quartile Range|Median
1353394|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Intact Parathyroid Hormone (PTH)|PTH regulates calcium and phosphate metabolism in bone and kidney, and is typically measured in serum using the intact PTH assay. Percentage = (PTH value at specified time points - PTH value at baseline) / PTH value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum PTH assessed at baseline and the specified time points.|||percentage change in PTH||Inter-Quartile Range|Median
1353504|NCT01752023|Primary|Tumor Blood Flow.|To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.|6 weeks.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
1353395|NCT01753856|Secondary|Percentage of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS or dLS/BS) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. Percentage = (Single or double TET labels / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label surface measured in the specified compartments of the iliac crest.|||percentage of TET label||Inter-Quartile Range|Median
1353396|NCT01753856|Secondary|Change From Baseline to 3 Months in Bone Formation Rate/Bone Surface (BFR/BS ) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BFR/BS is the volume of mineralized bone formed per unit surface of bone per unit of time [mm cubed per mm squared per year (mm³/mm²/year)]. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicates active bone formation, a SL or NL suggests suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 mcm/day or counted as missing. NL cases were assigned a value of zero.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with BFR/BS assessments in the specified compartments of the iliac crest.|||mm³/mm²/year||Inter-Quartile Range|Median
1353397|NCT01753856|Secondary|Change From Baseline to 3 Months in Mineral Apposition Rate (MAR) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|MAR is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between 2 consecutive labels divided by the time interval. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation. SL cases were imputed to a value of 0.3 micrometers per day (µm/day) or counted as missing. NL cases were reported as missing.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an evaluation of MAR in the CC, EC, IC and PC of the iliac crest.|||mcm/day||Inter-Quartile Range|Median
1353398|NCT01753856|Secondary|Change From Baseline to 3 Months in Label Length Within Each Basic Multicellular Unit (BMU) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BMUs are local groups of osteoblasts and osteoclasts that act in concert to complete a single remodeling cycle. The label length is a measure of the extent of the mineralization front within each BMU in the CC, EC, IC and PC. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label lengths measured in the specified compartments of the iliac crest.|||millimeters (mm)||Inter-Quartile Range|Median
1353399|NCT01753856|Secondary|Percentage of Overfilled Remodeling Sites in the CC, EC and PC of the Iliac Crest Bone Biopsies|The percentage of overfilled remodeling sites in the CC, EC, and PC were defined as the percentage of observed remodeling units in which the second DL (TET) extended beyond the limits of the scalloped reversal line and into the adjacent, previously unresorbed surface of the bone. Percentage = (overfilled remodeling bone formation unit / total bone formation unit) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy evaluated for overfilled remodeling sites in the specified compartments of the iliac crest.|||percentage of overfilled remodeling site||Inter-Quartile Range|Median
1353400|NCT01753856|Secondary|Percentage of Mineralizing Surface With Remodeling-Based Formation and Modeling-Based Formation in the CC, EC and PC of the Iliac Crest Bone Biopsies|"The percentage of mineralizing surface where post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling based bone formation based on collagen fiber orientation and whether the underlying reversal line was scalloped or smooth.~Percentage = percentage remodeling- or modeling-based formation units * MS/BS"|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling- or modeling-based formation in the specified compartments of the iliac crest.|||percentage of the total formation unit||Full Range|Median
1353401|NCT01753856|Secondary|Percentage of Bone With Remodeling-Based and Modeling-Based Formations in the CC, EC and PC of the Iliac Crest Bone Biopsies|In this study, post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling-based bone formations which was determined by whether the underlying reversal line was scalloped or smooth and by the collagen fiber orientation. Percentage = (remodeling-based formation units or modeling-based formation units/ total bone formation units) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling-based or modeling-based formation in the specified compartments of the iliac crest.|||percentage of the total formation unit||Inter-Quartile Range|Median
1353412|NCT01753713|Primary|Arm 1: Progression Free Survival (PFS)|Number of anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM). The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6. Progression is defined using the Response Assessment in Neuro-Oncology (RANO) Criteria where CR = Total disappearance of lesions, PR = >50% reduction in lesions and SD = <25% reduction in lesions|6 months||||Participants|||Count of Participants
1353402|NCT01753856|Secondary|MS/BS in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies 3 Months Post First Dose of Study Drug|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
1353403|NCT01753856|Secondary|Change From Baseline to 3 Months in MS/BS in the Endocortical Compartment (EC), Intracortical Compartment (IC), and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
1353404|NCT01753856|Secondary|Number of Samples With Single or Double Tetracycline Labels, SL and DL, or No Tetracycline Labels in the CC, Endocortical Compartment (EC), Intracortical Compartment (IC) and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies||3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of the number of samples with specified labels in the various compartments of the iliac crest.|||Samples|||Number
1353405|NCT01753856|Primary|Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling, and calculated as the sum of the total extent of double label (DL) plus half the extent of single label (SL) divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or no label (NL) suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the CC of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
1353406|NCT01753713|Other Pre-specified|Changes From Baseline in Circulating Growth Factors and Soluble Receptors.|To assess the pharmacodynamic effect of dovitinib on potential plasma biomarkers that may include measuring concentrations of circulating, microparticles, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, SDF-la, thrombospondin-l, Angl, and 11-6, IL-8 and FGF.|Up to 30 days after treatment|||||||
1353407|NCT01753713|Secondary|Overall Survival|The Kaplan-Meier method will be used. Overall survival is defined as the time from randomization to death.|to death, approximately 2 years||||Months||95% Confidence Interval|Median
1353408|NCT01753713|Secondary|Median Progression Free Survival|The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6|6 months||||Months||95% Confidence Interval|Median
1353409|NCT01753713|Secondary|Objective Response Rate Using Modified Revised Assessment in Neuro-Oncology (RANO) Criteria|Number of patients (both populations) with a complete response (CR-no measurable disease), partial response (PR >50% reduction in measurable disease), minor response (MR >25% reduction of measurable disease), stable disease (SD <25% reduction) and progressive disease (PD >25% measurable disease and new lesions).|Up to 30 days after treatment||||Participants|||Count of Participants
1353410|NCT01753713|Secondary|Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Number of adverse events in patients in both populations (grade 1-5). Grade 1 are defined as mild events characterized as asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention indicated. Grade 2 are moderate events with minimal, local or non invasive interventions indicated. Grade 3 are severe or medically significant events but not immediately life-threatening; hospitalization indicated. Grade 4 are life-threatening consequences with urgent intervention indicated. Grade 5 are deaths related to events|Assessed until 30 days after treatment up to 32 weeks||||Events|||Number
1353411|NCT01753713|Primary|Arm 2: Determine Median Time to Progression|Anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) patients with recurrent glioblastoma (GBM). Time to tumor progression (TTP), is defined as the time from randomization to time of progressive disease. So it is ongoing and will be assessed every 8 weeks …8, 16, 24, 32 …week. Progression is defined as >25% increase in size of lesions or evidence of new lesions|From randomization to time of progression every 8 weeks (2 cycles of treatment) up to 32 weeks||||Months||95% Confidence Interval|Median
1353413|NCT01753557|Secondary|Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)||From baseline to 24 weeks after completion of drug administration||||participants|||Number
1353414|NCT01753557|Secondary|Transition of Serum HCV RNA Levels||baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks||||log IU/mL||Inter-Quartile Range|Median
1353419|NCT01753518|Secondary|Cosmetic Outcome|The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is ‘1’, and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the ‘Overall Opinion’ of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar.|Measured at 6 week postoperative appointment|Not all patients or observers completed the scales. For the six items on the patient scale, N=44:52, but the overall opinion responding was N=43:51. For the observer scale the number responding was N=43:52 for vascularity, thickness, pliability, and surface area. N=42:52 for pigmentation and relief; N=42:50 for overall opinion.|||units on a scale||Inter-Quartile Range|Mean
1353420|NCT01753518|Primary|Skin Closure Time, All Resident Levels|Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat|||minutes||Inter-Quartile Range|Median
1353421|NCT01753518|Secondary|Surgeon Satisfaction (Per Procedure)|"Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision? How willing are you to recommend this skin closure (whether it was staples or suture) to a patient? How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section? There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with not at all,' not very, and no opinion being a negative response, and somewhat and extremely  being a positive response. Categories reported were negative, (including no opinion), and positive."|Immediately after the procedure (day 1)|A satisfaction survey wasn't completed for all of the procedures (103 per arm), so the reporting population is 91 for the suture arm, and 96 for the staple arm.|||Surgeons reporting per category|||Number
1353422|NCT01753518|Secondary|Patient Satisfaction|Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).|At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment|The reduction in the number of participants analyzed is due to not all participants completing the questionnaire, and all the questions. For appearance of incision, N=58:69. For willingness to use treatment again, N=59:68.|||participants|||Number
1353423|NCT01753518|Secondary|Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic|Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .|From day of procedure until end of hospital stay (typical dismissal on day 4)||||participants|||Number
1353424|NCT01753518|Secondary|Postoperative Pain|Post-operative pain was assessed by pain medication use through chart review.|From day of procedure until end of hospital stay (typical dismissal on day 4)||||mg||Inter-Quartile Range|Median
1353425|NCT01753518|Secondary|Participants With Postoperative Complications, by Type|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|Participants could have experienced more than one type of postoperative complication. Note: wound dehiscence is a surgical complication in which a wound ruptures along surgical suture. A seroma is a pocket of clear serous fluid. A hematoma is a localized swelling that is filled with blood caused by a break in the wall of a blood vessel.|||participants|||Number
1353426|NCT01753518|Secondary|Total Number of Participants With Postoperative Complications|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|The number of participants analyzed was reduced because some patients did not return for postpartum followup visits.|||participants|||Number
1353427|NCT01753518|Primary|Total Surgical Time, All Resident Levels|Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat|||minutes||Inter-Quartile Range|Median
1353428|NCT01753336|Secondary|TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
1353436|NCT01753323|Secondary|T1/2 - Part 2|T1/2 was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hours||Standard Deviation|Mean
1353429|NCT01753336|Secondary|TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
1353430|NCT01753336|Secondary|TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
1353431|NCT01753336|Secondary|Treatment Response in Treatment Cycle 3 Week 4.|Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.|Week 4 Treatment Cycle 3|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. For Treatment Cycle 3 there were 91 evaluable subjects.|||percentage of participants||95% Confidence Interval|Number
1353432|NCT01753336|Secondary|TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
1353433|NCT01753336|Primary|TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
1353434|NCT01753323|Secondary|Vz/F - Part 2|Vz/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||Liters||Standard Deviation|Mean
1353435|NCT01753323|Secondary|CL/F - Part 2|CL/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who who vomited before 3 hours.|||L/hr||Standard Deviation|Mean
1353437|NCT01753323|Secondary|Tmax - Part 2|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hours||Full Range|Median
1353438|NCT01753323|Secondary|Cmax - Part 2|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||ng/mL||Standard Deviation|Mean
1353439|NCT01753323|Secondary|AUCinf - Part 2|AUCinf was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Deviation|Mean
1353440|NCT01753323|Secondary|AUClast - Part 2|AUClast was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Deviation|Mean
1353441|NCT01753323|Secondary|AUC0-48h - Part 2|AUC0-48h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Error|Mean
1353442|NCT01753323|Secondary|AUC0-24h - Part 2|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Error|Mean
1353443|NCT01753323|Secondary|Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1|Racc was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||ratio||Standard Deviation|Mean
1353444|NCT01753323|Secondary|Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1|Vz/F was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||Liters||Standard Deviation|Mean
1353445|NCT01753323|Secondary|Clearance (CL/F ) - Part 1|CL/F was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||L/hr||Standard Deviation|Mean
1353446|NCT01753323|Secondary|Half-life (T1/2) - Part 1|T1/2 was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hr||Standard Deviation|Mean
1353447|NCT01753323|Secondary|Area Under the Curve (AUC)Inf - Part 1|AUCinf was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1353448|NCT01753323|Secondary|Area Under the Curve (AUC)Last - Part 1|AUClast was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hr*ng/mL||Standard Error|Mean
1353449|NCT01753323|Secondary|Time to Maximum Concentration (Tmax) - Part 1|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hour||Full Range|Median
1353450|NCT01753323|Secondary|Maximum Concentration (Cmax) - Part 1|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||ng/mL||Standard Error|Mean
1353451|NCT01753323|Secondary|Area Under the Curve (AUC)0-24h - Part 1|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose was taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||(hr*ng/mL)||Standard Deviation|Mean
1353452|NCT01753323|Primary|28-day Cure Rate - Part 2|28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment.|Day 28|Intent-to-treat analysis set: the intent-to-treat analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1353453|NCT01753323|Primary|Time to Parasite Clearance|Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments.|Day 5|Pharmacodynamic (PD) analysis set for Cohorts 1, 2 and 3: The PD set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation, and 1 participant from Cohort 3, who was withdrawn on Day 1.|||Hours||95% Confidence Interval|Median
1353454|NCT01753310|Secondary|Change From Baseline in CDIP-58 Total Score at Week 2.|The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.|2 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (6 from the Dysport® arm and 2 from the Placebo arm) had missing values for CDIP-58.|||units on a scale||Standard Deviation|Mean
1353455|NCT01753310|Secondary|Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.|The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.|4 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (7 from the Dysport® arm and 1 from the Placebo arm) had missing values for CDIP-58.|||units on a scale||Standard Deviation|Mean
1353456|NCT01753310|Secondary|TWSTRS Responders at Week 4.|Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.|4 weeks post-treatment|The ITT population consisted of all randomised subjects.|||percentage of participants||95% Confidence Interval|Number
1353457|NCT01753310|Secondary|Change From Baseline in CGIC in CD at Week 4.|The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.|4 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 3 subjects (all from the Dysport® arm) had missing values for CGIC.|||units on a scale||Standard Deviation|Mean
1353458|NCT01753310|Secondary|TWSTRS Responders at Week 2.|Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.|2 weeks post-treatment|The ITT population consisted of all randomised subjects.|||percentage of participants||95% Confidence Interval|Number
1353459|NCT01753310|Secondary|Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.|The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.|2 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 4 subjects (3 from the Dysport® arm and 1 from the Placebo arm) had missing values for CGIC.|||units on a scale||Standard Deviation|Mean
1353460|NCT01753310|Secondary|Change From Baseline in TWSTRS Total Score at Week 2.|The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.|2 weeks post-treatment|The ITT population consisted of all randomised subjects.|||units on a scale||Standard Deviation|Mean
1353487|NCT01752712|Secondary|Brief Psychiatric Rating Scale (BPRS) Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
1353461|NCT01753310|Primary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.|The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.|4 weeks post-treatment|The modified ITT population consisted of all randomised subjects with both a baseline and a Week 4 post-treatment TWSTRS total score assessment.|||units on a scale||Standard Deviation|Mean
1353462|NCT01753115|Secondary|Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels|Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.|Two weeks after last vaccination|BioThrax immunogenicity population: received 3 vaccinations and had samples taken within the study-specified windows; had a valid immunogenicity result within 2 wks of the last vaccination; had no evidence of previous anthrax vaccination and received the correct BioThrax dose at all 3 times; received vaccine maintained at the proper temperature.|||titer||95% Confidence Interval|Geometric Mean
1353463|NCT01753115|Primary|Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)|Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).|Day 5 and Day 44 in Arm 1|Per protocol population: all subjects in arm 1 who received any dose of ciprofloxacin, had adequate PK data on Day 5 and Day 44, had received all three BioThrax doses, and who had no key protocol deviations (e.g., insufficient blood sample) that would be expected to affect the ciprofloxacin PK assessment.|||ratio||90% Confidence Interval|Mean
1353464|NCT01753076|Secondary|Change From Baseline in the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) Total Score at Week 48|The ALSAQ-40 is a disease specific health status assessment for individuals with ALS/motor neuron disease. The ALSAQ-40 is comprised of 40 questions measuring 5discrete dimensions of health status that are affected by the disease: physical mobility (10 items); activities of daily living and independence (10 items); eating and drinking (3 items); communication (7 items); emotional reactions (10 items). Participants were asked to indicate the frequency of each event by selecting one of five options (Likert scale: 0-4): never/rarely/sometimes/often/ always or cannot do at all. The total score (minimum possible score=0, maximum possible score=160) was calculated by adding the five domain scores. A low score indicates a better health state. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. A mixed-model repeated measures adjusted for treatment, Visit, Treatment by Visit, and Baseline ALSAQ-40 total score was used for the analysis.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed|||Scores on a scale||Standard Error|Least Squares Mean
1353465|NCT01753076|Secondary|Change From Baseline in the EuroQol 5 Dimensions-5 Level Short Form (EQ-5D-5L) Utility Score at Week 48|A utility score for each participant was calculated based on the value set for England. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. EQ-5D-5L is a standardized, participant-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant’s health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). . For each of these dimensions, the participant self assigned a score: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (extreme problems).Minimum score on scale was 1 and maximum score was 5 for each dimension. A negative change from Baseline indicates improvement.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1353466|NCT01753076|Secondary|Progression-free Survival at Week 48|Progression-free survival at Week 48 is defined as the time from randomization to progression (decline of at least six points on the ALSFRS-R from Baseline) or death or censored at Week 48, whichever comes first. Kaplan Meier estimates at Week 48 were evaluated at Day 344. A participant was considered to have completed if he/she was censored at Day 344. Confidence intervals were estimated using the Brookmeyer Crowley method. Results are shown as the estimated percentage of participants alive and without disease progression at Week 48.|Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed.|||Percentage of participants surviving||95% Confidence Interval|Number
1353467|NCT01753076|Secondary|Overall Survival at Week 48 and Week 60|Overall survival is defined as the time from randomization to death or censoring at the time point of analysis, whichever comes first. Kaplan Meier estimates at Week 48 were evaluated at Day 344. A participant was considered to have completed if he/she was censored at Day 344. Kaplan Meier estimates at Week 60 were evaluated at Day 428. A participant was considered to have completed if he/she was censored at Day 428. Confidence intervals were estimated using the Brookmeyer Crowley method. Results are shown as the estimated percentage of participants alive at Weeks 48 and 60. Week 48: Only on-treatment data (data within 21 days of the last dose) were analyzed. Week 60: Including off treatment data (data after 21 days after the last dose) were analyzed.|Week 48 and Week 60|ITT Population|||Percentage of participants||95% Confidence Interval|Number
1353468|NCT01753076|Secondary|Number of Clinical Global Impression-improvement Scale (CGI-I) Responders at Week 48|The CGI-I scale is a single observer-rated item measuring global improvement relative to Baseline. The CGI-I score is rated on a 7-point scale, from 1 (very much improved) to 7 (very much worse). Participant status at Baseline was assessed using the Clinical Global Impression Severity scale (CGI-S), which is a 7-point scale (1: normal, not at all ill; 7: most extremely ill) used to rate the severity of the participant's illness. Participants achieving a score of 1-4 in the CGI-I at Week 48 were considered to be responders. A a logistic regression adjusted for CGI-S at Baseline, riluzole use, and world region was used for the analysis.|Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1353469|NCT01753076|Secondary|Change From Baseline in Muscle Strength as Measured by Hand Held Dynamometry (HHD) Score at Week 48|The HHD is a device placed between the hand of the practitioner and the tested body part and provides a quantified measurement of muscle strength. Each muscle was tested twice, and both values were recorded. Additionally, a third trial could have been performed if the variability between the first two trials was greater than 15 % or if the rater thought that one of the first two trials was not valid. The Week 0 (Visit 2) value was considered to be the Baseline value. Percent change from Baseline for each muscle group was calculated as 100*(HHD score minus the Baseline score) divided by the Baseline score. The average percent change was the mean percent change across the muscle groups that were non-missing/non-zero at Baseline. MMRM adjusted for treatment, visit, treatment by visit, number of non-missing/non-zero muscle groups at Baseline, number of non-missing/non-zero muscle groups at Baseline by Visit, riluzole use, and country group was used for the analysis.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.|||Percent change||Standard Error|Least Squares Mean
1353470|NCT01753076|Secondary|Change From Baseline in Slow Vital Capacity (SVC) at Week 48|SVC was measured by using a validated spirometer. Three SVC measurements were performed for each participant at each assessment provided the difference from the second trial (if arranged by the numerical value) was not greater than 10%. If the difference between the best and the next best (based on the largest numerical value) SVC value from the first three trials was greater than 10%, additional trials (up to 5 in total) could have been performed. The Week 0 (visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. A mixed-model repeated measures (MMRM) adjusted for treatment, visit, treatment by visit, Baseline SVC, Baseline SVC by visit, riluzole use. and country group was used for the analysis.|Baseline and Week 48|ITT population. Only those participants available at indicated time points were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
1353471|NCT01753076|Secondary|Rate of Decline Over Week 48 in the ALSFRS-R Total Score|The rate of decline was estimated by the change from Baseline in ALSFRS-R. The monthly slope for the ALSFRS-R score (i.e., the monthly rate of decline) was calculated as change from Baseline in the ALSFRS-R score at the last visit for that treatment period divided by the study day at the last visit for that treatment period devided by 30.4. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Baseline to Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed..|||change in scores on a scale per month||Standard Error|Least Squares Mean
1353472|NCT01753076|Secondary|Change From Baseline in the ALSFRS-R Total Score at Week 48|The rate of decline was estimated by the change from Baseline in ALSFRS-R. The monthly slope for the ALSFRS-R score (i.e., the monthly rate of decline) was calculated as change from Baseline in the ALSFRS-R score at the last visit for that treatment period divided by the study day at the last visit for that treatment period /30.4. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Baseline and Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1353473|NCT01753076|Primary|Joint Rank Scores for Combined Analysis of Function (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [ALSFRS-R] Score) and 48 Week Overall Survival|The joint rank score is a combined assessment of function and survival. Function is assessed using change from Baseline in the ALSFRS-R total score. To calculate joint rank scores, every participant was compared with all other participants in a pair wise manner and assigned a score of -1, 0 or 1 based on their relative outcomes. A subject's joint rank score is the sum of their scores across the pair wise comparisons. The . The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing. Lower scores of ALSFRS-R reflect greater impairment.|Week 48|ITT population. Only on-treatment data (data within 21 days of the last dose) were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1353474|NCT01752907|Secondary|Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles|Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.|From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.|Full analysis set|||percentage of participants|||Number
1353475|NCT01752907|Secondary|Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting|"Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following:~Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE."|From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.|Full analysis set|||percentage of participants|||Number
1353488|NCT01752712|Secondary|Schedule for Assessment of Negative Symptoms (SANS) Total Score|SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a SANS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
1353476|NCT01752907|Secondary|Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting|Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.|From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks|Full analysis set|||percentage of participants|||Number
1353477|NCT01752907|Secondary|Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation|||units on a scale * days||Standard Error|Mean
1353478|NCT01752907|Secondary|Mean Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation|||units on a scale||Standard Error|Mean
1353479|NCT01752907|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for each treatment cycle|Full analysis set with imputation|||units on a scale||Standard Deviation|Mean
1353480|NCT01752907|Primary|Maximum Patient-reported Bone Pain in Cycle 1|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1 to 5 during cycle 1.|Full analysis set with imputation|||units on a scale||Standard Error|Mean
1353481|NCT01752855|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Week 24 through Week 48|All participants who received at least one dose of study drug.|||percentage of participants|||Number
1353482|NCT01752855|Primary|Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|Data from participants receiving the new formulation of adalimumab in Study NCT01712178 were analyzed for 44 and 43 participants, respectively, at weeks 36 and 48. Data for the participants receiving the current formulation of adalimumab in Study NCT01712178 were analyzed for 43 participants at week 36 and 40 participants at week 48.|||units on a scale||Standard Deviation|Mean
1353483|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.|||percentage of participants|||Number
1353484|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.|||percentage of participants|||Number
1353485|NCT01752855|Primary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All available data were included. If a participant did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Deviation|Mean
1353486|NCT01752712|Secondary|Brief Psychiatric Rating Scale (BPRS) Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
1353489|NCT01752712|Secondary|Asocial Belief Scale (ABS) Total Score|Determine if CBSST + oxytocin compared to CBSST + placebo is associated with asocial beliefs. The total ABS score is calculated by adding the scores for items #1-#15. Each scale is provided a True/False response, with True responses equaling 1 point and False responses equaling 0 points. In calculating the ABS total score, four of the 15 items of the ABS were reverse scored. A lower total score indicates more severe asocial beliefs.|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a ABS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
1353490|NCT01752712|Secondary|Defeatist Performance Attitudes Scale (DPAS) Total Score|"Determine if CBSST + oxytocin compared to CBSST + placebo is associated with defeatist performance beliefs. The total DPAS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Agree Totally to 7=Disagree Totally. Total scores range from a minimum score of 18 to a maximum score of 126. Reverse scoring was applied to make higher scores indicate a stronger defeatist attitude."|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a DPAS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
1353491|NCT01752712|Primary|Birchwood Social Function Scale (BSFS) Total Score|"Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. There are 7 individual sections, with each section asking about different aspects of social functioning. Scores for Section 1: Social Engagement Withdrawal range from 0-15; Section 2: Interpersonal Communication/Relationships ranges from 0-30; Section 3: Prosocial Activities range is 0-66; Section 4: Recreation ranges from 0-48; Section 5: Independence (Performance) ranges from 0-39; Section 6: Independence (Competence) ranges from 0-39; and Section 7: Occupation/Employment ranges from 0-6 if the participant is unemployed or 7-10 if the participant is employed. The minimum value possible is 0 for participants who are unemployed and 7 for those with employment. The total BSFS score is calculated by adding the total scores from each of the 7 sections, with a maximum total score of 247. A lower total score indicates a lower social function rating."|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BSFS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
1353492|NCT01752400|Secondary|Median Overall Survival|The median duration of time from the start of treatment until the time of death or until the participant withdraws participation in the trial.|From the start of treatment until death or withdrawal from the study||||Months||95% Confidence Interval|Median
1353493|NCT01752400|Secondary|ALK Mutation Status|The number of secondary ALK mutations or ALK amplification as a mechanism of resistance in pre-treatment and post-treatment biopsies.|Baseline, end of treatment|Data not available for the other 5 participants|||Participants|||Count of Participants
1353494|NCT01752400|Secondary|ALK Translocation Variant Type||Baseline|Data unavailable for all six participants||||||
1353495|NCT01752400|Secondary|Number of Participants With Concurrent KRAS Mutations||Baseline||||Participants|||Count of Participants
1353496|NCT01752400|Secondary|Number of Participants Who Develop Adverse Events on AUY922|The number of participants that developed any grade adverse event as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)|From the start of treatment until 30 days after last dose was received||||Participants|||Count of Participants
1353497|NCT01752400|Secondary|Disease Control Rate|"The number of participants that achieved disease control, which includes complete responses, partial responses or stable disease as assessed by RECIST v1.1~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Baseline and then every six weeks (± 7 days), until the time of disease progression||||Participants|||Count of Participants
1353498|NCT01752400|Secondary|Progression-free Survival|"Progression free survival is measured as the number of months from date of study entry to date of progression or death, whichever comes first. Progression is assessed using RECIST v1.1.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression."|From the start of treatment until the time of death or progression||||Months||95% Confidence Interval|Median
1353499|NCT01752400|Primary|Objective Response Rate|"The number of participants that achieved either a complete response (CR) or a partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Baseline and then every six weeks (± 7 days), until the time of disease progression||||Participants|||Count of Participants
1353500|NCT01752023|Secondary|Tumor Necrosis|To assess changes in tumor necrosis in response to cisplatin and gemcitabine with or without SUBATM-itraconazole.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
1353501|NCT01752023|Secondary|Itraconazole Exposure Parameters|To correlate itraconazole exposure parameters with median time to progression and median survival in this patient population.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
1353502|NCT01752023|Secondary|Adverse Effects|To characterize the adverse effects of cisplatin and gemcitabine with or without SUBATM-itraconazole in this patient population.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
1353503|NCT01752023|Secondary|Median Time to Progression|To determine the median time to progression and median duration of survival of patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
1353505|NCT01752023|Primary|Objective Response Rates|Per response evaluation criteria in solid tumors criteria|6 weeks|Trial closed due to early stopping rule, patients were not analyzed as there were only 3 patients enrolled.||||||
1353507|NCT01751971|Secondary|Subjective Sleep Quality (Oxygen vs Sham)|"Better(+1)/Same(0)/Worse(-1) on oxygen vs sham, i.e. a relative comparison between arms. When subjects had completed the entire study, they were asked to compare subjectively their sleep quality on the first versus second study."|1 night|Patients with AHI>20. One patient, whose treatment and sham nights were separated by an extended duration (due to scheduling), did not provide data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1353508|NCT01751971|Secondary|Overnight Change in Diastolic Blood Pressure|The change in diastolic blood pressure overnight. Two supine oscillometric measurements of blood pressure are made: just prior to lights out (evening), and after lights on (morning).|1 night|Patients with AHI>20|||mmHg||Standard Error|Mean
1353509|NCT01751971|Secondary|Overnight Change in Systolic Blood Pressure|The change in systolic blood pressure overnight. Two supine oscillometric measurements of blood pressure are made: just prior to lights out (evening), and after lights on (morning).|1 night|Patients with AHI>20|||mmHg||Standard Error|Mean
1353510|NCT01751971|Secondary|Frequency of EEG Arousals (Events Per Hour)|Frequency of scored EEG arousals per hour of non-REM sleep. Note: Our objective was to describe changes in secondary outcomes within phenotypic subgroups. Overall effects (unselected patients / ignoring phenotypic subgroups) are first presented below, followed by effects in favorable vs. unfavorable subgroups.|1 night|Patients with AHI>20|||events/hr||Standard Error|Mean
1353511|NCT01751971|Primary|Apnea-hypopnea Index|"Apnea-hypopnea index (AHI) will be compared between oxygen and sham nights. Hypopneas are based on 30% reduction in airflow (no desaturation or arousal criteria). AHI data are exclusive to non-REM supine sleep.~The results presented here are for the AHI at each intervention (per intervention) regardless of the sequence (preferred clinicaltrials.gov format).~Please note, however, that the a priori outcome measure was the reduction in AHI with oxygen as a percent of sham values, i.e. (AHI on sham - AHI on oxygen)/(AHI on sham) % (a comparison with greater statistical power), compared between patient subgroups (see Statistical Analysis section).~Subgroups were defined a priori as higher (>=0.7) versus lower loop gain (<0.7), but tests were also performed in subgroups defined by favorable versus unfavorable pathophysiology."|1 night|Patients with AHI>20|||events/hour||Standard Error|Mean
1353512|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO)|"In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.~Overall Health Status~Disease-Specific Quality of Life~Dyspnea severity~Anxiety"|5 years|||||||
1353513|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO)|"In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.~Overall Health Status~Disease-Specific Quality of Life~Dyspnea severity~Anxiety"|4 years|||||||
1353514|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO)|"In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.~Overall Health Status~Disease-Specific Quality of Life~Dyspnea severity~Anxiety"|3 years|||||||
1353515|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO)|"In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.~Overall Health Status~Disease-Specific Quality of Life~Dyspnea severity~Anxiety"|2 years|||||||
1353516|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Dyspnea Severity|"Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).~Rose Dyspnea Scale:~Scale range: 0 to 4~Lower values represent better outcomes (higher scores indicate worse dyspnea)~No subscales"|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353517|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Dyspnea Severity|"Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).~Rose Dyspnea Scale:~Scale range: 0 to 4~Lower values represent better outcomes (higher scores indicate worse dyspnea)~No subscales"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353518|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Dyspnea Severity|"Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).~Rose Dyspnea Scale:~Scale range: 0 to 4~Lower values represent better outcomes (higher scores indicate worse dyspnea)~No subscales"|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353519|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Disease-Specific Quality of Life|"Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).~Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353520|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Disease-Specific Quality of Life|"Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).~Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353521|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Disease-Specific Quality of Life|"Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ)~Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353522|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Anxiety|"Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).~GAD-7:~Scale range: 0 to 21~Lower values represent better outcomes~No subscales"|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353523|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Anxiety|"Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).~GAD-7:~Scale range: 0 to 21~Lower values represent better outcomes~No subscales"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353524|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Anxiety|"Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).~GAD-7:~Scale range: 0 to 21~Lower values represent better outcomes~No subscales"|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353525|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Overall Health Status|"Overall health status assessed using the EuroQoL 5D (EQ-5D™).~EQ-5D:~Scale range: 0 to 1~Higher values represent better outcomes~Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status."|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353526|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Overall Health Status|"Overall health status assessed using the EuroQoL 5D (EQ-5D™).~EQ-5D:~Scale range: 0 to 1~Higher values represent better outcomes~Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353527|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Overall Health Status|"Overall health status assessed using the EuroQoL 5D (EQ-5D™).~EQ-5D:~Scale range: 0 to 1~Higher values represent better outcomes~Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status."|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
1353528|NCT01751906|Secondary|Optical Coherence Tomography (OCT) Endpoint|"All OCT endpoints will be collected for within the device and within the treated segment:~Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions"|3 years|||||||
1353529|NCT01751906|Secondary|Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Area Change, From Post-procedure to 3 Years by Intravascular Ultrasound (IVUS)|"Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.~Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT."|3 years|||||||
1353530|NCT01751906|Secondary|Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Diameter Change, Between Pre- and Post-nitrate Infusion at 3 Years by Angiography|Pooled angiographic subjects (~600 subjects): 200 subjects from the Imaging Cohort of ABSORB III and 400 subjects from the ABSORB Japan RCT.|3 years|||||||
1353531|NCT01751906|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||1-5 years|||||||
1353532|NCT01751906|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||1-4 years|||||||
1353533|NCT01751906|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||1-3 years|||||||
1353534|NCT01751906|Secondary|Landmark Analysis on TLF and Components||1-5 years|||||||
1353535|NCT01751906|Secondary|Landmark Analysis on TLF and Components||1-4 years|||||||
1353536|NCT01751906|Secondary|Landmark Analysis on TLF and Components||1-3 years|||||||
1353537|NCT01751906|Secondary|Post-Procedure In-Device Percent Diameter Stenosis (%DS)|Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Percent Diameter stenosis|Target Lesions|Standard Deviation|Mean
1353538|NCT01751906|Secondary|Post-Procedure In-Segment Percent Diameter Stenosis (%DS)|"Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold."|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Percent Diameter stenosis|Target Lesions|Standard Deviation|Mean
1353564|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|2 years|||||||
1353539|NCT01751906|Secondary|Post-Procedure In-Device Minimum Lumen Diameter (MLD)|Angiographic endpoint.|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Millimeter|Target Lesions|Standard Deviation|Mean
1353540|NCT01751906|Secondary|Post-Procedure In-Segment Minimum Lumen Diameter (MLD)|Angiographic endpoint. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Millimeter|Target Lesions|Standard Deviation|Mean
1353541|NCT01751906|Secondary|Pre-Procedure Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|< or = 1 day|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Percent Diameter stenosis|Target Lesions|Standard Deviation|Mean
1353542|NCT01751906|Secondary|Pre-Procedure Minimum Lumen Diameter (MLD)|Angiographic endpoint|< or = 1 day|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Millimeter|Target Lesions|Standard Deviation|Mean
1353543|NCT01751906|Secondary|Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)|Evidence (Definite, Probable and Possible)|5 years|||||||
1353544|NCT01751906|Secondary|Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)|Evidence (Definite, Probable and Possible)|4 years|||||||
1353545|NCT01751906|Secondary|Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)|Evidence (Definite, Probable and Possible)|3 years|||||||
1353546|NCT01751906|Secondary|Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)|Evidence (Definite, Probable and Possible)|2 years|||||||
1353547|NCT01751906|Secondary|Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|0 to 393 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353548|NCT01751906|Secondary|Number of Participants With Very Late Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|366 to 393 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353549|NCT01751906|Secondary|Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|31 to 365 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353565|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353783|NCT01749956|Secondary|Overall Survival Probability at 6 and 12 Months|The probability of overall survival at 6 months and 12 months from date of first protocol treatment until date of death.|up to 1 year||||probability||95% Confidence Interval|Number
1353550|NCT01751906|Secondary|Number of Participants With Acute/Subacute Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|0 to 30 days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353551|NCT01751906|Secondary|Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|> 1 to 30 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353552|NCT01751906|Secondary|Number of Participants With Acute Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|≤ 1 Day|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353553|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|5 years|||||||
1353554|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|4 years|||||||
1353555|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|3 years|||||||
1353556|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|2 years|||||||
1353557|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353558|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353559|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353560|NCT01751906|Secondary|Number of Participants With Death/All MI/All Revascularization (DMR)|The composite of Death, All MI and All revascularization.|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353561|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years|||||||
1353562|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years|||||||
1353566|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353567|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353568|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353569|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|5 years|||||||
1353570|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 years|||||||
1353571|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|3 years|||||||
1353572|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|2 years|||||||
1353573|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353574|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353575|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353576|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353577|NCT01751906|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|5 years|||||||
1353578|NCT01751906|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|4 years|||||||
1353579|NCT01751906|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|3 years|||||||
1353580|NCT01751906|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|2 years|||||||
1353581|NCT01751906|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353582|NCT01751906|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353583|NCT01751906|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353584|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|5 years|||||||
1353585|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|4 years|||||||
1353586|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|3 years|||||||
1353587|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|2 years|||||||
1353588|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353589|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353590|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353591|NCT01751906|Secondary|Number of Participants With Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353592|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|5 years|||||||
1353593|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|4 years|||||||
1353594|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|3 years|||||||
1353595|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|2 years|||||||
1353596|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353597|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353629|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353598|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353599|NCT01751906|Secondary|Number of Participants With Death/All MI|All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353600|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|5 years|||||||
1353601|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|4 years|||||||
1353602|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|3 years|||||||
1353603|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|2 years|||||||
1353604|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353605|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353606|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353607|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|5 years|||||||
1353608|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|4 years|||||||
1353609|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|3 years|||||||
1353610|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|2 years|||||||
1353611|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353612|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353613|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353630|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353614|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353615|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|5 years|||||||
1353616|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|4 years|||||||
1353617|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|3 years|||||||
1353618|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|2 years|||||||
1353619|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353620|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353621|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353622|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353623|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|5 years|||||||
1353624|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|4 years|||||||
1353625|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|3 years|||||||
1353626|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|2 years|||||||
1353627|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353628|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353631|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|5 years|||||||
1353632|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years|||||||
1353633|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|3 years|||||||
1353634|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|2 years|||||||
1353635|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353636|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353637|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353668|NCT01751412|Secondary|Late Toxicities|Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.|5 years|The trial was terminated before the study endpoint was met. The data is not available for analysis.||||||
1353638|NCT01751906|Secondary|Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per Academic Research Consortium (ARC)) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353639|NCT01751906|Secondary|Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)|This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.|1 year|For ID-TVR, Fisher’s exact test is used for superiority testing based on the ITT population. This analysis will include ~2000 subjects. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
1353640|NCT01751906|Secondary|Number of Participants With Powered Secondary Endpoint: All Revascularization|This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.|1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through 1 year without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
1353641|NCT01751906|Secondary|Number of Participants With Powered Secondary Endpoint: Angina|Angina is defined as the first adverse event resulting in the site diagnosis of angina.|1 year|The analysis will exclude angina following the index procedure through discharge, not to exceed a period of 7 days. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353642|NCT01751906|Secondary|Acute Success: Procedural Success (Subject Level Analysis)|Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).|On day 0 (the day of procedure)|ITT set. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up|||Participants|||Count of Participants
1353643|NCT01751906|Secondary|Acute Success- Device Success (Lesion Level Analysis)|Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.|On day 0 (the day of procedure)|ITT set. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up|||percentage of target lesions|Target Lesions||Number
1353644|NCT01751906|Primary|Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|1 year|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1353645|NCT01751867|Secondary|Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ C-30) Physical Functioning Scale|"EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning."|Baseline to end of treatment (approximately up to 2 years)|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. The missing data was imputed by the Last Observation Carried Forward (LOCF).|||Scores on a scale||Standard Deviation|Mean
1353646|NCT01751867|Secondary|Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.||From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1353647|NCT01751867|Secondary|Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)|Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration|Up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug.|||Percentage of total days||Standard Deviation|Mean
1353648|NCT01751867|Secondary|Transfusion Independence: Number of Participants Who Were Transfusion Independent|A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more.|Baseline; up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. Here, 'n' is the number of participants analyzed at specified time point.|||Participants|||Number
1354003|NCT01745913|Secondary|Transfusion Requirements After Haplo-identical Umbilical Cord Blood Transplant Versus Double Umbilical Cord Blood Transplant||estimation of 24 months to determine transfusion requirements of all subjects|||||||
1353649|NCT01751867|Secondary|Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria|As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR).|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Participants who had baseline cytogenetic abnormality and had at least one post baseline cytogenetic assessments during study.|||Percentage of Participants|||Number
1353650|NCT01751867|Secondary|Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows <= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of >= 1.5 g/dL, platelet increase of >= 30,000/mL (starting with > 20,000/mL), neutrophils increase of >= 100% and > 500/μL.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.|||Participants|||Number
1353651|NCT01751867|Primary|Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population: Participants who received at least one dose of study medication.|||Participants|||Number
1353652|NCT01751802|Secondary|Safety Summary of Ecopipam in Patients With Lesch-Nyhan Disease: Total Number of Serious and Non-Serious Adverse Events Experienced During 3 Double-blind Crossover Periods|An additional objective of the study is to assess the safety of ecopipam in subjects with LND for up to 52 weeks. Total number of serious and non-serious adverse events experienced by participants while receiving ecopipam or placebo. For additional detail, see Adverse Events|Total duration over which participants recieved double-blind ecopipam or placebo, up to 6 or 12 weeks|All participants who received at least one dose|||adverse events|||Number
1353653|NCT01751802|Secondary|Effect of Ecopipam Withdrawal and Maintenance|The secondary objectives of this study are to assess the effect of withdrawal and maintenance of ecopipam's effects in subjects with LND. Measured by the number of participants whose score changes significantly from baseline on ecopipam or placebo|Baseline, 6 weeks, 12 weeks, 18 weeks|0 participants analyzed because data are not reliable||||||
1353654|NCT01751802|Primary|Behavior Problems Inventory - Self-Injurious Behavior Subscale|The primary endpoint is the BPI (SIB subscales - total for frequency and severity) as assessed by the caregiver. BPI Self-Injurious Behavior Subscale ranges from 0 to 45, with higher scores indicating more self-injurious behavior.|Baseline, end of period 1 (6 weeks), end of period 2 (12 weeks), end of period 3 (18 weeks),|All participants who completed the BPI-Self Injurious Behavior survey for 3 or more time points|||scores on a scale||Standard Deviation|Mean
1353655|NCT01751724|Other Pre-specified|Number of Infants With Severe Retinopathy of Prematurity|Severe retinopathy of prematurity defined as stage 3 or higher|From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
1353656|NCT01751724|Other Pre-specified|Number of Infants With Severe Intraventricular Hemorrhage|Severe intraventricular hemorrhage defined as grade III or higher|From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
1353657|NCT01751724|Other Pre-specified|Number of Infants With Septicemia|Septicemia defined as positive blood culture|From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
1353658|NCT01751724|Other Pre-specified|Number of Infants With Necrotizing Enterocolitis||From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
1353659|NCT01751724|Other Pre-specified|Number of Infants With Pulmonary Hemorrhage||From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
1353660|NCT01751724|Secondary|Survival Without BPD|Discharge alive without BPD. BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.|From the time of randomization until 36 weeks corrected age, discharge or death||||Participants|||Count of Participants
1353661|NCT01751724|Secondary|Number of Infants With Bronchopulmonary Dysplasia (BPD)|BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.|Evaluated at 36 weeks corrected postmenstrual age|Infants alive at 36 weeks postmenstrual age|||Participants|||Count of Participants
1353662|NCT01751724|Secondary|Total Duration of Oxygen Supplementation||From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age|Infants alive at 36 weeks postmenstrual age|||days||Inter-Quartile Range|Median
1353663|NCT01751724|Secondary|Total Duration of Mechanical Ventilation||From the time of first intubation until the last extubation, up to 36 weeks corrected age|Infants alive at 36 weeks postmenstrual age|||days||Inter-Quartile Range|Median
1353664|NCT01751724|Secondary|Survival||From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death||||Participants|||Count of Participants
1353665|NCT01751724|Primary|Age at First Successful Extubation|Defined as age of extubation with infant remaining extubated for more than 24 hours.|From birth to until 36 weeks postmenstrual age||||days||Inter-Quartile Range|Median
1353666|NCT01751412|Secondary|6-Month Progression-Free Survival|The number of participants surviving without disease progression six months after the start of treatment|6 Months||||Participants|||Count of Participants
1353667|NCT01751412|Secondary|6-Month Overall Survival|The number of participants surviving six months after starting treatment|6 Months||||Participants|||Count of Participants
1353669|NCT01751412|Secondary|Number of Participants With Acute Toxicities|Acute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia. Data is shown as the number of participants that experienced the given toxicities.|90 Days||||participants|||Number
1353670|NCT01751412|Secondary|Local Control|The number of participants who maintained local control for the duration of their followup. Local control is defined as the lack of disease progression. Progression is the increased growth of cancer cells or the spread of the cancer cells to another location within the body.|2 years||||Participants|||Count of Participants
1353671|NCT01751412|Primary|Radiation Dose to the Normal Tissue of the Lungs|The percentage of the lung volume which received radiation dose of 20 Gray (Gy) or more. The lung volume percentages for the 12 participants were averaged and presented separately for the left and right lungs.|6 Weeks||||Percentage of Lung Volume||Full Range|Mean
1353672|NCT01751412|Primary|Mean Radiation Dose to Normal Heart Tissue|The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).|6 weeks||||Gy(RBE)||Full Range|Mean
1353673|NCT01751386|Primary|Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session|Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.|2 hours|The analysis included all subjects who took the medication (either baclofen or placebo) and finished the alcohol laboratory session|||mini-drinks||Standard Error|Mean
1353674|NCT01751308|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time (in months) from the date of first dose administration until the date of death (from any cause). If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive and the study cut-off date. The analysis was performed by Kaplan-Meier method.|Baseline up to death or study cut-off (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.|||months||95% Confidence Interval|Median
1353675|NCT01751308|Secondary|Phase 2: Progression Free Survival (PFS)|The PFS was defined as the time (in months) from the date of first dose administration until the date of first documented PD or death (from any cause), whichever came first. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. PD as per RANO criteria was defined as ≥25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) plus any increase in tumor cross-sectional area (or tumor volume). The analysis was performed by Kaplan-Meier method.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.|||months||95% Confidence Interval|Median
1353676|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.|||ng/mL||Standard Deviation|Mean
1353677|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.|||L/m^2||Standard Deviation|Mean
1353678|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.|||L/h/m^2||Standard Deviation|Mean
1353679|NCT01751308|Secondary|Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve|Blood samples for PK parameters were collected at 5 minutes before end of infusion (EOI), 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|PK population (for both Phase 1 and Phase 2 parts of the study) included all participants who received treatment on Day 1 of Cycle 1 and had at least one post-dose PK sample. Number of participants analyzed=participants with available data for this endpoint.|||ng.h/mL||Standard Deviation|Mean
1353680|NCT01751308|Secondary|Phase 1: Number of Participants With Objective Response|OR in participants was defined as the participants with a CR or PR after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1 and RANO criteria for CNS tumors. For solid tumors, as per RECIST 1.1, CR defined as disappearance of all target and non-target lesions (any pathological lymph nodes, must had reduction in short axis to <10 mm); PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For CNS tumors, as per RANO criteria, CR defined as disappearance of all target and non-target lesions; PR defined as a ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.|||participants|||Number
1353784|NCT01749956|Secondary|Overall Survival|Measured from date of first protocol treatment until date of death.|Every 3 months (±1 month) following documented progression, up to 5 years or death, whichever comes first.||||participants||95% Confidence Interval|Median
1353681|NCT01751308|Secondary|Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. Treatment emergent adverse events (TEAEs) were defined as AEs that developed or worsened in grade or became serious during the on-treatment period which was defined as the period from the time of first dose of cabazitaxel until 30 days following the last administration of cabazitaxel.|Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2)|Analysis was performed on safety population (AT population).|||participants|||Number
1353682|NCT01751308|Primary|Phase 2: Duration of Response (DOR)|DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. If progression or death was not observed, participant was censored at the date of participant’s last progression-free tumor assessment prior to study cut-off date. PD as per RANO criteria was defined as ≥ 25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) plus any increase in tumor cross-sectional area (or tumor volume).|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Due to no objective responses in Stage 1 of Phase 2, the analysis of duration of response was not performed.Hence, the data is not reported.||||||
1353683|NCT01751308|Primary|Phase 2: Percentage of Participants With Objective Response (OR)|OR in participants was defined as the participants with a Complete Response (CR) or Partial Response (PR) after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks. CR and PR were based on modified response assessment in neuro-oncology (RANO) criteria for participants with CNS tumors. CR was defined as disappearance of all target lesions. PR was defined as ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to the baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Efficacy evaluable population was subset of AT population with measurable disease with a baseline and at least one post-baseline tumor evaluation.Number of participants analyzed=participants with available data for this endpoint.|||percentage of participants|||Number
1353684|NCT01751308|Primary|Phase 1: Maximum Tolerated Dose of Cabazitaxel|MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases<10* upper limit of normal of ≤7 days, re-treatment delay of>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Cycle 1 (21 days)|DLT evaluable population defined as a subset of participants in the Phase 1 part of the study from the AT population who received the first dose of cabazitaxel and had sufficient safety evaluations or experienced a DLT during Cycle 1.|||mg/m^2|||Number
1353685|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores|Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on ITT population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
1353686|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores|Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
1353687|NCT01751178|Secondary|Gingival Index|The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
1353688|NCT01751178|Primary|Gingival Severity Index (GSI) Based on the Gingival Index (GI)|"Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and,~GSI = 0 if GI is 0 or 1 (no bleeding)~GSI = 1 if GI is 1 or 2 (bleeding)"|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
1353689|NCT01751165|Secondary|Number of Subjects With pIMDs.|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From one month (30 Days) following the last vaccine administration up to study end at Month 24|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1353690|NCT01751165|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1353691|NCT01751165|Secondary|Number of Days With Solicited General Symptoms.|Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.|During the 7 Days (Day 0-6) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days|||Number
1353692|NCT01751165|Secondary|Number of Days With Solicited Local Symptoms.|Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.|During the 7 Days (Day 0-6) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days|||Number
1353693|NCT01751165|Secondary|Number of Subjects With SAE(s).|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|Starting from 30 Days post last vaccine administration up to study end at Month 24|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1353694|NCT01751165|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|From first vaccination up to one month (30 Days) post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1353695|NCT01751165|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30 Days (Day 0-29) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1353696|NCT01751165|Secondary|Number of Subjects With Solicited General Symptoms.|"Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = fatigue that prevented normal activity. Grade 3 Gastrointestinal = gastrointestinal that prevented normal every day activities. Grade 3 Headache = headache that prevented normal activity. Grade 3 Myalgia = myalgia that prevented normal activity. Grade 3 Shivering = shivering that prevented normal activity. Grade 3 Temperature = temperature higher than (>) 39.0°C."|During the 7 day period (Days 0-6) following each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1353697|NCT01751165|Secondary|Number of Subjects With Solicited Local Symptoms.|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 100 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity."|During the 7 day period (Days 0-6) following each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
1353698|NCT01751165|Secondary|Concentrations of Antibodies Against Anti-gE as Determined by ELISA.||Prior (PRE) to vaccination and twelve (M12) post Dose 2|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1353699|NCT01751165|Primary|Concentrations of Antibodies Against Anti-gE as Determined by ELISA.||At one month (M1) after Dose 2|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1353700|NCT01751165|Primary|Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).|"Vaccine response was defined as: for initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.~The objective required a comparison of VRR between 0,6-months and 0,12-months schedules."|At one month (M1) after Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1353701|NCT01751113|Secondary|Use of Rescue Medication (Number of Occasions Per 24-hour Period) as Recorded in the Daily Record Card at Day 28 of Each Treatment Period|Participants were given daily record cards for daily completion during the run-in, washout and treatment periods. Each morning, participants recorded the number of occasions in the last 24 hours when they had used their rescue medication (salbutamol) for symptomatic relief of COPD symptoms.|Day 28 of each treatment period (up to 35 days)|mITT Population. Only those participants available who used rescue medication at the specified periods were analyzed (represented by n=X, X, X in the category titles).|||Number of occasions||Standard Deviation|Mean
1354023|NCT01745380|Secondary|Number of Participants With a Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration||||participants|||Number
1353702|NCT01751113|Secondary|Post-dose FEV1/FVC Ratio (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
1353703|NCT01751113|Secondary|Post-dose FEV1, FVC, IC, RV, TLC and TGV (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the RV. RV is defined as the volume of air remaining in the lungs after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Liters (L)||Standard Error|Least Squares Mean
1353704|NCT01751113|Secondary|Trough sGaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||1/kPa*s||Standard Error|Geometric Mean
1353705|NCT01751113|Secondary|Trough sRaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||kPa*s||Standard Error|Geometric Mean
1353706|NCT01751113|Secondary|Trough FEV1/FVC Ratio, at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
1353707|NCT01751113|Secondary|Trough Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC), RV, TLC, and TGV at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the residual volume (RV). RV is defined as the volume of air remaining in the lungs. after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Liters (L)||Standard Error|Least Squares Mean
1353708|NCT01751113|Secondary|Post-dose sRaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. A natural logarithmic transformation was applied and the data was analysed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sRaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population|||kPa*s||Standard Error|Geometric Mean
1353709|NCT01751113|Secondary|Post-dose sGaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaws. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sGaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population|||1/kPa*s||Standard Error|Geometric Mean
1353710|NCT01751113|Secondary|AUC (0-4hr) Specific Airway Resistance (sRaw) After the Morning Dose of Each Study Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sRaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the LS means.|Day 28 of each treatment period (up to 35 days)|mITT Population|||kPa*s||Standard Error|Geometric Mean
1353725|NCT01751022|Secondary|Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||percentage of participants|||Number
1353781|NCT01749956|Secondary|Disease-Free Survival||Patients without evidence of progression will be followed every 3 months (±1 month) from date of last dose of study drug during Years 1-2, every 6 months during Years 3-4, and annually thereafter or until disease progression, estimated 5 years.|All evaluable patients.|||percentage of participants||95% Confidence Interval|Median
1353711|NCT01751113|Primary|Area Under the Curve Calculated From 0 to 4 Hours (AUC[0-4hr]) Specific Conductance (sGaw) After the Morning Dose of Study Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sGaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the Least Square (LS) means.|Day 28 of each treatment period (up to 35 days)|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study medication and completed at least two treatment periods and also had a Baseline and at least one on treatment sGaw assessment measure.|||1/kilopascal*second (1/kPa*s)||Standard Error|Geometric Mean
1353712|NCT01751087|Secondary|Physician Satisfaction With Cervical Preparation|Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.|physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes|"Data on whether the physician was satisfied with the cervical preparation is available for all participants except:~Arm 1: 1 participant withdrawn with no intervention; Arm 2: 1 participant who didn't have a D&E (expelled), Arm 3: 1 participant withdrawn with no intervention and one with missing data."|||participants||95% Confidence Interval|Number
1353713|NCT01751087|Secondary|Patient Satisfaction With Cervical Prep|Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.|patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days||||participants|||Number
1353714|NCT01751087|Secondary|Chills (Any) After Day 2 Medication Administration|chills (any) after Day 2 medication administration|assessed immediately after administration of day 2 medication||||participants||95% Confidence Interval|Number
1353715|NCT01751087|Secondary|Complications From Procedure|Patient having any complication, including hospitalizations transfusions additional unplanned procedures|assessed immediately after completion of D&E and at 1 week and 1 month post-procedure||||participants|||Number
1353716|NCT01751087|Secondary|Ease of Mechanical Dilation|Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Number of participants in each arm who required additional mechanical dilation|||participants|||Number
1353717|NCT01751087|Secondary|Need for Mechanical Dilation|Assessed on Day of procedure. Assessed immediately after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D&E. Arm 3: one subject withdrawn/no intervention|||participants||95% Confidence Interval|Number
1353718|NCT01751087|Secondary|Ability to Complete the D&E on the First Attempt|Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.|participants were assessed for the duration of the procedure, an average of 6 minutes||||participants|||Number
1353719|NCT01751087|Secondary|Initial Cervical Dilation|Measured at the time of procedure (immediately before the start of D&E)|participants were assessed during cervical dilation process, average time of 1 minute|Arm 1: 1 subject excluded [withdrawn/no intervention]. Arm 2: 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3: 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing]. Additionally missing data for one more subject in Arm 2.|||centimeters||Standard Deviation|Mean
1353720|NCT01751087|Primary|Operative Time|The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1 (dilators-alone): 1 subject excluded [withdrawn/no intervention]. Arm 2 (dilators + misoprostol): 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3 (dilators + mifepristone): 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing].|||minutes||Standard Deviation|Mean
1353721|NCT01751022|Secondary|Complication Rate for Individual Attain Performa Lead Related Events||6 month post-Implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||percentage of participants||95% Confidence Interval|Number
1353722|NCT01751022|Secondary|Pacing Impedance at the Final Programmed Pacing Polarity|"Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.~Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms)."|6 month post-implant|Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.|||Ohms||Standard Deviation|Mean
1353723|NCT01751022|Secondary|Implant Related Times Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||minutes||Standard Deviation|Mean
1353724|NCT01751022|Secondary|Pacing Capture Thresholds at the Final Programmed Pacing Polarity||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.|||Volts||Standard Deviation|Mean
1353726|NCT01751022|Secondary|Percentage of Subjects With Successful Implant Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||percentage of participants||95% Confidence Interval|Number
1353727|NCT01751022|Secondary|Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities|Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.|6 months post-implant|Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.|||percentage of participants|||Number
1353728|NCT01751022|Primary|LV Pacing Capture Thresholds Per Attain Performa Lead Model||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.|||percentage of participants||97.5% Confidence Interval|Mean
1353729|NCT01751022|Primary|Lead Complication-free Rate at 6 Months|"The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:~- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).~- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.~The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models."|Implant to 6 months post-implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||Survival Probability (%)||97.5% Confidence Interval|Number
1353730|NCT01750931|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, is medically important event or reaction, is associated with liver injury Alanine amino transferase (more than equal to [>=] 3 fold upper normal of limit [ULN]) or total bilirubin (>=2 fold ULN) or international normalization ratio more than 1.5. Refer to the general AE/SAE module for a list of AEs and SAEs.|Up to 20 days|All subject population.|||Participants|||Number
1353731|NCT01750931|Primary|Elimination Half Life (T-half) After a Single Dose|The T-half was calculated using the following formula by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Per hour||Full Range|Median
1353732|NCT01750931|Primary|Elimination Rate Constant (Kel) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semilogarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
1353733|NCT01750931|Primary|The Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUCpercentage [%]_Extrap [Residual Area]) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The percentage of area under curve extrapolated to arrive at AUC0-infinity (AUC%_Extrap [residual area]) was determined by AUC0-infinity minus AUC0-t divided by AUC0-infinity multiplied by 100.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Percentage of AUC Extrapolated||Geometric Coefficient of Variation|Geometric Mean
1353734|NCT01750931|Primary|The Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC(0-t) was area under the plasma concentration-time curve from time of administration until the time of last quantifiable concentration. The area under the plasma concentration-time curve (AUC0-infinity), was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Nanogram.hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1353735|NCT01750931|Primary|Time to Maximum Concentration (T-max)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The Tmax was taken directly from the plasma concentration-time profile of individual participants. Plasma samples for PK analysis were drawn at indicated time points.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population|||Hour||Full Range|Median
1353736|NCT01750931|Primary|Maximum Drug Concentration During the Selected Dosing Interval (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. The Cmax was taken directly from the plasma concentration-time profile of individual participants|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population: all participants who complete all periods of the study. All participants were present at the time of measurement.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1353737|NCT01750840|Secondary|Quality of Life Assessment|Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed.|The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.|No quality of life data was collected for any of the patients enrolled in the study. As such, no analysis was performed on quality of life measures.||||||
1353738|NCT01750840|Primary|Radiographic Assessment of Healing|Bone healing was assessed on x-rays and/or CT scan.|The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.|All patients, with one nonunion fracture each, were treated with the Biomet EBI Bone Healing System. Four patients had final healing outcomes reported (two patients with a 5th metatarsal nonunion, one patient with a tibial nonunion and one patient with a fibula nonunion) and all healed in an average time of 2.5 months.|||percentage of healed fractures|Fractures||Number
1353739|NCT01750684|Secondary|Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data|Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC).|baseline, prior to and up to 5 hours following last infusion|||||||
1353740|NCT01750684|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion.|up to 6 months|Safety Population|||participants|||Number
1353741|NCT01750502|Other Pre-specified|Comparison of MIF-173G/C Alleles of CHD Patients and Controls.||Before surgery|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.|||alleles|||Number
1353742|NCT01750502|Other Pre-specified|Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.||Before surgery||||participants|||Number
1353743|NCT01750502|Secondary|Comparison the Change of MIF Before and After Percutaneous Coronary Intervention （PCI） at the Patients Who Are Acute Coronary Syndromes and Stable Ischemic Heart Disease|Percutaneous Coronary Intervention are extracted 3 times including before surgery 5 minutes , 5 minutes after the opening of the balloon and after surgery 5 minutes ,and detection MIF concentration .|3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes|Coronary-artery-disease Group does not include myocardial infarction, 21 patients were acute myocardial infarction participants.|||MIF Concentration , ug/L||Standard Deviation|Mean
1353744|NCT01750502|Primary|Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration|Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.|Before surgery 5 minutes|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.|||MIF Concentration,ug/L||Standard Deviation|Median
1353745|NCT01750398|Secondary|Change in Waist Circumference||Bseline, 6 months and 9 months.||||cm||Standard Deviation|Mean
1353746|NCT01750398|Secondary|Change in Weight|Change in weight is measured from baseline to 6 months (i.e. following ADT lead in) and from 6 months to 9 months (i.e. from post-ADT to the end of cycle 1 of BAT).|Baseline, 6 months and 9 months.||||kg||Standard Deviation|Mean
1353747|NCT01750398|Secondary|Quality of Life Survey|"To measure quality of life through the RAND-SF36 (short-form 36 questionnaire) Quality of Life Survey, the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P), the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS) and a visual pain scale. Note that for all scales, higher scores indicate better quality of life/function, with the exception being the visual pain scale, where a higher score indicates more pain.~RAND-SF36: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Range is from 0 to 100.~FACT-P: A tool used for assessing the health-related quality of life in men with prostate cancer. Range is from 0 to 156.~IIEF: Is a measure of erectile function. Range is from 5 to 25. IPSS: A tool used to measure symptoms related to prostatic disease. Range is from 0 to 35.~Visual pain scale: A tool used to track pain level. Range is from 0 to 10."|3 months||||units on a scale||Full Range|Median
1353748|NCT01750398|Secondary|Change in C-telopeptides|Change in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months)|6 months and 9 months||||pg/ml||Standard Deviation|Mean
1353749|NCT01750398|Secondary|Complete PSA Response|To evaluate the number of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) at the end of the study|18 months||||participants|||Number
1353750|NCT01750398|Secondary|Radiographic or Clinical Progression|To evaluate the number of men treated per the bipolar androgen therapy phase of the trial who developed radiographic or clinical progression. Radiographic progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was defined as new symptoms that can be attributed to progressive prostate cancer (e.g. new/worsening pain, urinary obstruction, cord compression, bone fractures).|18 months||||participants|||Number
1353751|NCT01750398|Primary|Patients With PSA <4 ng/mL at the End of the Study|To determine the clinical effects of BAT in men with recurrent prostate cancer as first line therapy. This will be accomplished by assessing the number of patients achieving a PSA <4 ng/ml at the end of the trial.|18 months||||participants||90% Confidence Interval|Number
1353752|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 7 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 7 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|7 months||||units on a scale|||Number
1353753|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 6 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 6 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|6 months||||units on a scale|||Number
1353754|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 3 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 3 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|3 months||||units on a scale||Full Range|Mean
1353755|NCT01750346|Secondary|The Blepharospasm Disability Scale at 2 Months|The Blepharospasm Disability Scale (BDS) was measured at 2 months from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|2 months||||units on a scale||Full Range|Mean
1353756|NCT01750346|Secondary|The Blepharospasm Disability Scale at 1 Month|The Blepharospasm Disability Scale (BDS) was measured at 1 month from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|1 month||||units on a scale||Full Range|Mean
1353757|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 1 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 1 month from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|1 month||||units on a scale||Full Range|Mean
1353758|NCT01750346|Primary|The Jankovic Blepharospasm Rating Scale at 2 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) at 2 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|2 months|One participant in the 0.05% AH-8 arm was withdrawn due to development of blepharitis.|||units on a scale||Full Range|Mean
1353759|NCT01750294|Primary|Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks||Baseline and 12 weeks after intervention|Intention to treat analysis (includes completers and non-completers)|||mmHg||Standard Deviation|Mean
1353760|NCT01750281|Secondary|Overall Survival (OS)|The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive|Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)|Full Analysis Set (All randomised patients)|||Months||Inter-Quartile Range|Median
1353780|NCT01749956|Secondary|Disease Free Survival Probability at 6 and 12 Months|The probability of disease free survival at 6 and 12 months after initiating protocol treatment.|Up to 1 year||||probability||95% Confidence Interval|Number
1353761|NCT01750281|Primary|Progression Free Survival (PFS)|Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.|Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)|Full Analysis Set (All randomised patients). Progression events that do not occur within 14 weeks of the last evaluable assessement are censored and therefore excluded.|||Months||Inter-Quartile Range|Median
1353762|NCT01750255|Secondary|Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy|Quantify the preventable causes of problems of effectiveness and safety of pharmacotherapy. Quantify the process problems like a drug availability problems, problems in prescribing, dispensing problems, administration and use, quality problem.[Time Frame: At 3, 6, 9 and 12 months]|1 year|||||||
1353763|NCT01750255|Secondary|Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy|Necessity problems of pharmacotherapy are related to the following two questions: 1) The patient has a health problem associated with not receiving a medication you need? 2) The patient has a health problem associated with getting a medicine that does not need. The safety of the pharmacotherapy will be measured by the safety profile of drugs and serum concentrations of drugs. The effectiveness of the pharmacotherapy will be measured by Hamilton Rating Scale for Depression, Clinical Global Impressions (CGI), Young Mania Rating Scale.|1 year|||||||
1353764|NCT01750255|Secondary|Depression|To assess depressive symptoms, will be used the the Hamilton Depression Rating Scale. [Time Frame: At 3, 6, 9 and 12 months]using hamilton depression scale|1 year|||||||
1353765|NCT01750255|Secondary|Mania||1 year|||||||
1353766|NCT01750255|Secondary|Clinical Global Impression for Bipolar Modified, CGI-BP-M.|The modified version of the Clinical Global Impression for Bipolar Disorder (CGI-BP-M) a condensed version of the CGI-BP, which is also an adaptation of the CGI for bipolar patients. The CGI-BP-M, is a scale for the assessment of manic, hypomanic, depressive or mixed symptoms, and long-term outcome of bipolar disorder. Assesses the current gravity, the short and long term of the disease course. It consists of three subscales, composed of a single item, evaluating the severity of the acute symptoms of depression, mania and disease in general (refers to the longitudinal disease severity). It has a Likert intensity scale of 7 degrees of freedom ( 1 normal, 7 very severe).|1 year||||Clinical Global Impression||Standard Deviation|Mean
1353767|NCT01750255|Secondary|Adherence to Treatment|Total percentage of adherence by treatment group|1 year|Total percentage of adherence by treatment group|||Medication adherence percentage|||Number
1353768|NCT01750255|Secondary|Quality of Life|The Short Form-36 Health Survey (SF-36): It is a questionnaire to measure quality of life, exploring the physical and mental health. Contains 36 topics that explore 8 dimensions of health: physical function; social function; limitations of the role: physical problems; limitations of the role: emotional problems; mental health; vitality; pain and general health perception. Each of the 8 dimensions of the SF-36 scores range between 0 and 100 values. 100 being a result indicating optimal health and 0 would reflect in a very bad state of health. The questionnaire allows the calculation of 2 scores summary, physical component summary (PCS) and mental (MCS), by combining each dimension scores|1 year||||Mental health summary score||Standard Deviation|Mean
1353769|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits||1 year||||Outpatient-unscheduled visits|||Number
1353770|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations||1 year||||Emergency Service Consultations|||Number
1353771|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations||1 year||||Hospitalizations|||Number
1353772|NCT01750242|Secondary|Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores|The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108.|Change from baseline to 18 months|Per protocol|||units on a scale||Standard Deviation|Mean
1353773|NCT01750242|Primary|To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap|The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.|18 months|Per Protocol|||percentage of leads|Participants||Number
1353774|NCT01750229|Primary|Visual Analog Scale (VAS) on Back Pain|Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.|12 weeks|Per-protocol population, subjects who followed the protocol and provided data for all four randomized crossover period were included in the analysis.|||units on a scale||Standard Deviation|Mean
1353775|NCT01750086|Primary|Bone Turnover Marker (Blood Sample)|The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.|8 weeks||||percentage of change in CTX||Standard Deviation|Mean
1353776|NCT01749982|Primary|Change in Urinary % Dimethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)||||percentage of total urinary arsenic||Full Range|Median
1353777|NCT01749982|Primary|Change in Urinary % Inorganic Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)||||percentage of total urinary arsenic||Full Range|Median
1353778|NCT01749982|Primary|Change in Urinary % Monomethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)||||percentage of total urinary arsenic||Full Range|Median
1353779|NCT01749956|Secondary|The Number of Participants Who Experienced Serious or Non-Serious Adverse Events as a Measure of Safety.|Adverse events and serious adverse events (AEs and SAEs) were graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0. Specific AE and SAE terms are provided in the Adverse Event module.|weekly for 6 weeks pre-op then every 2 weeks post-op, approximately 36 weeks|All patients who received at least one dose of protocol treatment.|||participants|||Number
1353785|NCT01749956|Primary|Pathologic Complete Response Rate|The Pathologic Complete Response (pCR) Rate is defined as the number of pathologic complete responders among all patients evaluable for response, including evaluable patients who did not proceed to surgery. A pCR is defined as the absence of any residual abnormality detected in a pathological specimen.|Between days 57 and 98 after preoperative chemotherapy|All patients enrolled in the trial who were evaluable for pathologic response. Four patients were not evaluable for response.|||participants|||Number
1353786|NCT01749800|Primary|Sustained Attention to Response Task|Subjects are presented with objects (one at the time) on a computer screen and are instructed to press a key on the keyboard according to the characteristics of the object shown on the computer screen. Error rates are measured as percentage of erroneous key selections.|Baseline and end-of-treatment data (up to 2 weeks)||||percentage errors||Full Range|Mean
1353787|NCT01749735|Primary|Change in Box and Block Test Score From Baseline|"The Box and Block Test is a functional test. Subjects are instructed to move small blocks from one box to a second box. The test measures the number of blocks that subjects can move during a period of 60 sec. The measurement unit for this task is the number of blocks. Subjects with no motor impairments would typically move about 60 to 80 blocks in a period of 60 sec."|Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post||||number of blocks||Standard Deviation|Mean
1353788|NCT01749735|Primary|Change in Jebsen-Taylor Hand Function Test Score From Baseline|The Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.|Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post||||seconds||Standard Deviation|Mean
1353789|NCT01749631|Secondary|Mean Number of Intubation Attempts||Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||number of attempts||Standard Error|Mean
1353790|NCT01749631|Secondary|Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane|The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.|From start of induction to completion of intubation (up to 30 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.|||percentage of participants|||Number
1353791|NCT01749631|Secondary|Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure|The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.|Start of intubation to completion of intubation (up to 15 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.|||percentage of participants|||Number
1353792|NCT01749631|Secondary|Mean Duration of Intubation Procedure (in Minutes)|The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]).|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||minutes||Standard Error|Mean
1353793|NCT01749631|Secondary|Percentage of Participants With Mallampati Score III and IV|Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.|Screening|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||percentage of participants|||Number
1353794|NCT01749631|Secondary|Mean Duration of Induction (in Seconds)|The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.|From start of induction up to 15 minutes|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||seconds||Standard Error|Mean
1353795|NCT01749631|Primary|Percentage of Participants With Successful Intubation (Clinical Success)|Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||percentage of participants|||Number
1353796|NCT01749605|Primary|Number of Participants With Clinical Cure at Day 7|Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure)|7 days||||participants|||Number
1353797|NCT01749501|Secondary|Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.||24 hours after intubation procedure||||minutes||Standard Deviation|Mean
1353815|NCT01748760|Primary|Number of Participants Who Repoorted a Suicide Event|A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.|6 months||||participants|||Number
1353798|NCT01749501|Primary|Present the Percentage of Participants With an Excellent Ease of Intubation Rating|"percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"|24 hours after intubation period||||% reported as excellent|||Number
1353799|NCT01749410|Primary|Change From Baseline in the Number of Headache Days|The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.|Treatment Cycle 7 (approximately 1.5 years)|All subjects who satisfied the inclusion and exclusion criteria|||Days||Standard Deviation|Mean
1353800|NCT01748955|Secondary|Change in Suicidal Ideation (SSI Score)|Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts|Measured at Baseline and Week 8||||units on a scale||Standard Deviation|Mean
1353801|NCT01748955|Primary|Percent Change in Contrast of Parameter Estimates (COPE)|"% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task.~Task conditions are:~Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents"|Measured at Baseline (pre-treatment) and Week 8 (post-treatment)|Major depressive disorder with suicidal thoughts or past suicide attempt.|||Percentage change||Full Range|Mean
1353802|NCT01748942|Secondary|Days With Feeding Tube||12 months||||days||Full Range|Median
1353803|NCT01748942|Secondary|UM-QOL Eating|"The University of Michigan Head and Neck Quality of Life Questionnaire (UM-QOL) is 20 item, 1-5 scale, questionnaire that measures how much the patient has been bothered during various activities as a result of head and neck condition or treatment in the past four weeks with 1= Not at all and 5=Extremely. The scores are calculated using a Likert Scale, which transforms the 1-5 choices into a 0-100 scale with 100 being normal and 0 being poor quality of life. This test contains separate domains (eating, etc.) that can be scored independently. Scores were analyzed between cohorts pre and post operatively."|21 days||||units on a scale||Standard Deviation|Mean
1353804|NCT01748942|Secondary|Opioid Use||3 days||||mg of oxycodone equivalent||Standard Deviation|Mean
1353805|NCT01748942|Secondary|PSS Normalcy of Diet|"Performance Status Score (PSS) - Normalcy of Diet score is a 0-100 scale that measures diet restrictions with 0= Non-oral feeding (tube fed) and 100 = Full diet (no restrictions)"|30 days||||units on a scale||Standard Deviation|Mean
1353806|NCT01748942|Secondary|Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)|Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.|Up to 21 days||||days||Standard Deviation|Median
1353807|NCT01748942|Secondary|Eating Assessment Tool (EAT)-10 Scores|"Statistical Analysis between placebo and steroid cohorts to assess differences. The Eating Assessment Tool (EAT-10) is a 10 item questionnaire that evaluates swallowing and the extent of how problematic with certain eating activities. Questions are answered using a five point (0-4) plus Not Applicable scale with 0 = No problem and 4= Severe problem. A descriptive time plot will be produced for EAT-10 scores using baseline and postoperative measurements on days 3 and day 7-21. Descriptive statistical analyses will be conducted for a summary of EAT-10 scores at baseline, days 3 and day 7-21 after surgery. A linear mixed effects model will be used to compare the EAT-10 scores between the two groups."|Up to 12 months||||units on a scale||Standard Deviation|Mean
1353808|NCT01748942|Secondary|Complications Associated With Postoperative Corticosteroid Use After TORS|A descriptive statistical analysis will be conducted on complications.|Up to 30 days||||Participants|||Count of Participants
1353809|NCT01748942|Primary|Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale|"Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating No pain and 10 indicating Worst possible, unbearable, excruciating pain. A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups."|21 days||||units on a scale||Standard Deviation|Mean
1353810|NCT01748916|Primary|Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato|The primary goal of this research is to investigate whether papaya can deliver increased quantities of carotenoids when compared to carrot and tomato. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) over time will be determined to quantify absorption, after subjects consume a meal containing papaya, carrot or tomato.|8 post-prandial blood samples over 9.5 hours||||nmol*h/L||Inter-Quartile Range|Median
1353811|NCT01748890|Primary|The Number of Core Biopsies in These Targeted Regions|From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.|Participants will be followed until prostatectomy pathology is available (average 1 week)|insufficient recruitment for analysis||||||
1353812|NCT01748799|Secondary|Cannabis Withdrawal|Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).|8 weeks|Only 9 of the 16 participants recruited completed the whole experimental sequence (participants were assigned to 1 of 8 different experimental sequences in a randomized order).|||units on a scale||Standard Deviation|Mean
1353813|NCT01748799|Secondary|Tolerability of Sativex in Persons That Are Cannabis Dependent|To assess what number of participants might withdrew due non-tolerability of Sativex|8 weeks|Data from 16 participants enrolled in the study was analyzed, none of the participants withdrew due non-tolerability of Sativex|||participants|||Number
1353814|NCT01748799|Primary|Feasibility|Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.|12 months|16 participants were enrolled in the study, 9 participants completed the whole (randomly assigned) experimental sequence|||participants|||Number
1354024|NCT01745380|Secondary|Number of Participants With a Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration||||participants|||Number
1353816|NCT01748695|Primary|Safety and Tolerability of V158866 Compared to Placebo|Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.|4 weeks||||Participants|||Count of Participants
1353817|NCT01748695|Primary|Mean Pain Intensity (NRS)|Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).|4 Weeks||||units on a scale||Standard Error|Mean
1353818|NCT01748643|Secondary|Forced Vital Capacity|Forced vital capacity is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))||||percent change from baseline||Standard Deviation|Mean
1353819|NCT01748643|Secondary|Forced Expiratory Volume in 1 Second|Forced expiratory volume in 1 second is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))||||percent change from baseline||Standard Deviation|Mean
1353820|NCT01748643|Secondary|Peak Expiratory Flow|Peak expiratory flow is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))||||percent change from baseline||Standard Deviation|Mean
1353821|NCT01748643|Primary|Duration of Surgery|Measured from the time of first skin incision to completion of skin closure.|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h||||minutes||Standard Deviation|Mean
1353822|NCT01748643|Primary|Number of Intra-abdominal Pressure Rises > 18cmH2O|The number of intra-abdominal pressure rises > 18cmH2O detected by the intra-abdominal CO2 insufflator.|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h||||number of intra-abdominal pressure rises||Standard Deviation|Mean
1353823|NCT01748643|Primary|Subjective Evaluation of the View on the Operating Field by the Surgeon|"At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale:~Extremely poor~Poor~Acceptable~Good~Optimal"|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h||||units on a scale||Standard Deviation|Mean
1353824|NCT01748292|Secondary|Mean Change in Central Foveal Thickness|Mean change in central foveal thickness by SD-OCT from baseline to weeks 48-57, baseline to week 104 and baseline to week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||microns||Standard Error|Mean
1353825|NCT01748292|Secondary|CNVM Lesion Size|CNVM lesion size at baseline, compared to baseline to weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128-132 and baseline to week 156, as determined by fluorescein angiography.|6, 12, 18, 24, 30, and 36 months||2018-06-30|06/2018||||
1353826|NCT01748292|Secondary|Percentage of Patients With Persistent Leakage on Fluorescein Angiography|Percentage of subjects with persistent leakage on fluorescein angiography from baseline through weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128- 132 and baseline to week 156.|6, 12, 18, 24, 30, and 36 months||2018-06-30|06/2018||||
1353827|NCT01748292|Secondary|Percentage of Subjects With Persistent Active Exudation on SD-OCT|Percentage of subjects with persistent active exudation on SD-OCT from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
1353828|NCT01748292|Secondary|Total Number of Office Visits and Imaging Studies Performed During Study Period|Total number of office visits and imaging studies performed from baseline through weeks 24-28 (week closest to week 26), baseline through weeks 48-56 (week closest to week 52), baseline through weeks 72-82 (week closest to week 78), baseline through week 104, baseline through weeks 128-132 (week closest to week 132) and baseline through week 156|6, 12, 18, 24, 30, and 36 months|Per protocol, imaging was conducted at each study visit and is assumed to be perfectly correlated with the number of visits. Therefore, only visits were specifically analyzed. Additionally, given the high correlation between number of visits and injections administered (reported previously), this analysis was performed only at M12, M24, and M36.|||scheduled visits completed|||Number
1353829|NCT01748292|Secondary|Total Number of Intravitreal Injections Required|Total number of intravitreal injections required from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||injections||Full Range|Mean
1353830|NCT01748292|Secondary|Incidence and Severity of Adverse Events (Ocular and Non-ocular)|Incidence and severity of adverse events both ocular and non-ocular|36 months||||Participants|||Count of Participants
1353852|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17|OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. All participants in the 10 mcg device-10 mcg dose and 20 mcg device-20 mcg dose (total 12 participants) are stated as not applicable as they tested the full dose."|||participants|||Number
1353831|NCT01748292|Primary|Mean Change in BCVA by ETDRS Letter Score From Baseline|Mean change in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline through weeks 24-28, baseline through weeks 48-56, baseline through weeks 72-82, baseline to week 104, baseline through weeks 128-132 and baseline to week 156. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. The scale ranges from 0 to 100 letters|6, 12, 18, 24, 30, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||ETDRS BCVA Letters||Standard Error|Mean
1353832|NCT01748240|Primary|Response Rate|"All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28 days.~The response rate (CR, PR, HI or marrow CR) will be evaluated after six cycles, according to IWG 2006.~In patients still responding after six cycles, the drugs will continue to be supplied, and follow up until death or unacceptable tolerance will be continued in all patients.~Complete Response (CR): Bone marrow: less than 5% myeloblasts with Peripheral blood: HI responses).~Partial remission (RP): Bone marrow blasts decreased by at least 50% but still more than 5% with Peripheral blood: HI responses).~Marrow CR:Bone marrow: maximum of 5% myeloblasts and decrease by at least 50% over pretreatment~HI (hematologic improvement)~Erythroid response: Hgb increase at least by 1.5 g/dL~Platelet response: Increase from less than 20x109/L to more than 20x109/L and by at least 100%~Neutrophil response: At least 100% increase and an absolute increase of at least 0.5x109/L"|6 month||||percentage of response||95% Confidence Interval|Number
1353833|NCT01748227|Secondary|Pain Centrality Scale|Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.|4 month assessment||||units on a scale||Standard Deviation|Mean
1353834|NCT01748227|Secondary|Patient Reported Outcome Measurement System (PROMIS)|Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.|Change from baseline to 4 month assessment||||units on a scale||Standard Deviation|Mean
1353835|NCT01748227|Secondary|Multidimensional Perceived Social Support Scale (MPSS).|12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).|Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance||||units on a scale||Standard Deviation|Mean
1353836|NCT01748227|Secondary|Pain Catastrophizing Scale|Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.|Baseline and 4 month assessment (final assessment)||||units on a scale||Standard Deviation|Mean
1353837|NCT01748227|Primary|Pain/Enjoyment of Life/General Activity|3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.|Change from baseline to 4 month assessment||||units on a scale||Standard Deviation|Mean
1353838|NCT01748162|Secondary|Severity of Croup Episodes|Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)|1 year|No participants completed to 1 year because of early study termination.||||||
1353839|NCT01748162|Primary|Quantity of Recurrent Episodes|Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.|1 year|No participants completed to 1 year because of early study termination.||||||
1353840|NCT01748071|Secondary|Mean Respiratory Frequency|According to the measurement of respiratory frequency after intravenous injection of opioid analgesics|10 minutes after the procedure||||breaths per minute||Standard Deviation|Mean
1353841|NCT01748071|Secondary|Mean Heart Rate|According to the measurement of heart rate before and after intravenous injection of opioid analgesics|10 minutes after the procedure||||beats per minute||Standard Deviation|Mean
1353842|NCT01748071|Secondary|Mean Arterial Pressure|According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics|10 minutes after the procedure||||mmHg||Standard Deviation|Mean
1353843|NCT01748071|Primary|Mean Value of Narco-trend Index|According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.|10 minutes after the procedure||||units on a scale||Standard Deviation|Mean
1353844|NCT01748071|Primary|Mean Pressure Pain Threshold|According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics|10 minutes after the procedure||||kg/cm2||Standard Deviation|Mean
1353845|NCT01748045|Secondary|Total Duration of Respiratory Support|participants were followed for the duration of hospital stay for respiratory support|From hospital admission through discharge||||days||Standard Deviation|Mean
1353846|NCT01748045|Secondary|Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)|defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)|12 months corrected gestational age|Analysis not performed at one year corrected age, since study closed.|||Participants|||Count of Participants
1353847|NCT01748045|Secondary|Diagnosis of Bronchopulmonary Dysplasia (BPD)|Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.|At 36 weeks postmenstrual age or 1-2month of age||||Participants|||Count of Participants
1353848|NCT01748045|Secondary|Total Duration of Supplemental Oxygen|Participants were followed for the duration of hospital stay for use of supplemental oxygen|From Hospital Admission through discharge||||days||Standard Deviation|Mean
1353849|NCT01748045|Secondary|Total Length of Hospital Stay|participants who were followed for the duration of hospital stay|From hospital admission through discharge||||days||Standard Deviation|Mean
1353850|NCT01748045|Secondary|Number of Participants Who Had the Need for Exogenous Surfactant||7 days||||Participants|||Count of Participants
1353851|NCT01748045|Primary|Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life||7 days||||Participants|||Count of Participants
1353945|NCT01746784|Secondary|Change in Biomarkers of CFTR Function|Sweat chloride millequivalents/Liter (mEq/L)|Change from baseline at Day 7|Change from baseline sweat chloride (mEq/L) to Study Day 14|||mEq/L||Standard Deviation|Mean
1353853|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16|OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353854|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b|OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353855|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13|"OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A Yes response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353856|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12|"OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353857|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11|"OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353858|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10|OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353859|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9|"OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353860|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8|OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353861|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7|"OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353862|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6|"OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
1353863|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5|OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
1353864|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4|"OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
1353865|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3|"OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
1353866|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2|OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant in the 10 mcg device-2.5 mcg dose was excluded as failure at Q1 did not involve mechanical failure or defect.|||participants|||Number
1353867|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1|"OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A No answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components."|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
1353868|NCT01747928|Secondary|Time Required to Perform Segments 1 to 5|Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. n=number of participants analyzed for that segment.|||seconds||Standard Deviation|Mean
1353869|NCT01747928|Secondary|Number of Participants Providing Responses to Any Question on the PAT|Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
1353870|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?|Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
1353871|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Most Difficult Step?|Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
1353872|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?|Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
1353873|NCT01747928|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?|Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
1353874|NCT01747928|Post-Hoc|DSSR Based on the Primary Objective|This post-hoc DSSR was calculated in order to provide a DSSR that recognized as a “failure” only those participants who were unable to successfully complete the overall injection task, regardless of whether they met with difficulties at any step.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||percentage of participants||95% Confidence Interval|Number
1353875|NCT01747928|Primary|Delivery System Success Rate (DSSR)|"DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/hands on demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption."|Day 1|The full analysis set (FAS) consisted of all protocol defined valid attempts to perform the study procedure as documented in the Observer Assessment Tool (OAT).|||percentage of participants||95% Confidence Interval|Number
1353876|NCT01747850|Secondary|Cannabis Use (Grams)|Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed|six months||||grams of cannabis||Standard Error|Mean
1353877|NCT01747850|Secondary|Cannabis Craving|"Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported.~Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana."|six months||||Total Craving Scores||Standard Deviation|Mean
1353878|NCT01747850|Secondary|Withdrawal|"Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported.~Range 0 – 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal."|six months||||Total Withdrawal score||Standard Deviation|Mean
1353879|NCT01747850|Secondary|Cannabis Use (in Days)|The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report)|six months||||percentage of days||Standard Deviation|Mean
1353880|NCT01747850|Primary|Tolerability|Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.|six months||||Participants|||Count of Participants
1353881|NCT01747811|Other Pre-specified|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks|The Beck Depression Inventory (BDI-II) is a self report scale utilized for measuring the severity of depression. Scores can range from 0-63 (0 meaning minimal depressive symptoms, and 63 being severe depressive symptoms). Participants are given this on baseline and post treatment.|Change from baseline at 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
1353946|NCT01746784|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson standards were used to calculate percent predicted FEV1 (for age, sex, and height).|Change from baseline at Day 7|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Study Day 7|||percentage||Standard Deviation|Mean
1353882|NCT01747811|Secondary|Performance on Neuropsychological Assessment|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological assessment that measures different facets of memory including the following: immediate memory, visuospatial/constructional, language, attention, and delayed memory. This is given to all participants on both pre and post treatment visits. The total range for this scale is 40-160. Lower values represent a worse outcome, and higher values represent an improved outcome.|Change from baseline at 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
1353883|NCT01747811|Secondary|Actigraphy-measured Sleep Quality|Actigraphy is an objective measure that determines sleep vs. wake. It is a watch with an accelerometer worn on the wrist. Sleep quality is determined by the amount of time in bed divided by the amount of time sleeping (in minutes).|Change from baseline at 6 weeks (post-treatment)|We collected usable actigraphy from 29 participants. The 7 remaining participants had unusable actigraphy data.|||minutes||Standard Deviation|Mean
1353884|NCT01747811|Secondary|Score on Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index is a self report measure of sleep quality. The overall score takes into account many different facets of sleep, such as sleep quality, sleep latency, sleep duration, sleep disturbances, etc. The scores range from 0-21, and any score that is equal to or greater than 5 is indicative of poor sleep quality.|Change from baseline at 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
1353885|NCT01747811|Secondary|Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task|Change from baseline in left prefrontal cortical response during a multi source interference task at six weeks. Methods utilized to assess activity in the left prefrontal cortex/inferior frontal operculum included a regions of interest analysis.|Change from baseline performance at 6 weeks (post-treatment)|A total of 22 participants had useable data, 4 participants were excluded due to movement in the images.|||Percent Signal Change||Standard Deviation|Mean
1353886|NCT01747811|Primary|Performance on Multiple Sleep Latency Test (MSLT)|The MSLT is a objective measure of sleepiness. Participants will take a brief nap 3 times during the 1st and second visit. The period of time between wake and sleep onset will be utilized as an objective measure of sleepiness (in minutes). A mean value will be calculated for the entirety of the pre-treatment napping periods and for the post treatment visits.|Change from baseline performance at 6 weeks (post-treatment)||||minutes||Standard Deviation|Mean
1353887|NCT01747772|Primary|Liver Elasticity Value Measured Using Sonoelastography (SE)|Liver elasticity/stiffness was assessed via SE and compared against results of liver biopsy as read by a single pathologist using the Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) 5-point scale (F [Fibrosis]0=no fibrosis, F1=portal fibrosis without septa, F2=portal fibrosis with few septa, F3=numerous septa without cirrhosis, and F4=cirrhosis). Using SE, fibrosis is measured in kilopascals (kPa) with normal values equaling approximately 5.5 kPa (normal liver stiffness ranges between 3.3-7.8 kPa). Significant Fibrosis (F3): = or > 7.6 kPa, Cirrhosis (F4): = or > 9.0- 26 kPa. A higher number corresponds to an increase in stiffness and hepatic fibrosis.|Day 1|The analysis population included all participants who completed the study and had adequate shear-wave sonoelastography (SWE) and liver biopsy data. 16 participants were excluded: 9 discontinued and 7 had inadequate SWE or biopsy data.|||kilopascals (kPa)||95% Confidence Interval|Mean
1353888|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months , including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||percentage of participants|||Number
1353889|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||percentage of participants|||Number
1353890|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||percentage of participants|||Number
1353891|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||visits at home||Standard Deviation|Mean
1353947|NCT01746784|Primary|Safety and Tolerability|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|Over 7 treatment days and 7 days of follow-up|Treatment emergent adverse events by Grade 1 (mild) to 5 (fatal)|||participants|||Number
1353948|NCT01746511|Secondary|Length of Initial Round of Phototherapy|time start to time finally off phototherapy, including any breaks during which they were off|from time of enrollment to time of discharge, for a maximum of 10 weeks||||hours||Standard Deviation|Mean
1353892|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||office visits||Standard Deviation|Mean
1353893|NCT01747655|Secondary|Parkinson’s Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked to state how often they had encountered certain problems over the past four weeks using the following rating scale: Never (0), occasionally (1), sometimes (2), often (3), always or cannot do at all (4). The PDQ-8 summary index was derived as the sum of the single items divided by 32. Scores range from 0 to 100. A higher summary index score indicates a higher impairment of quality of life. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353894|NCT01747655|Secondary|Non-Motor Symptoms Assessment Scale for Parkinson’s Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Non-motor symptoms assessed over the previous month were scored with respect to severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) and with respect to frequency (1 = rarely, 2 = often, 3 = frequent, 4 = very frequent). The total NMSS score ranges from 0 to 360 with higher values indicating greater impairment and was calculated as the sum of all individual score values. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353895|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|The UPDRS III questionnaire consists of 14 questions on motor examinations rated from 0 (absent/normal) to 4 (extreme impairment). Questions 20–26 are multi-part questions in that they are evaluated separately for multiple body parts (for example, for the left and right hand). Counting each of these assessments leads to a total of 27 answers. The UPDRS III score ranges from 0 to 108 with higher values indicating greater impairment and was calculated as the sum of the 27 answers provided to the 14 questions. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353896|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353897|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353898|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353899|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353900|NCT01747655|Secondary|Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study|The primary reasons for stopping treatment with Duodopa or for discontinuing the study.|12 months|Participants in the MAS who stopped treatment with Duodopa or discontinued from study.|||participants|||Number
1353901|NCT01747655|Secondary|Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment|The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube.|14 days|MAS population|||percentage of participants|||Number
1353902|NCT01747655|Secondary|Unified Parkinson’s Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353903|NCT01747655|Primary|Unified Parkinson’s Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data."|Baseline (Week 0) and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
1353904|NCT01747629|Secondary|Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||hour||Standard Deviation|Mean
1353905|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
1353906|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 1|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
1353907|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).~AUC0-t on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
1353908|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).~AUC0-6 on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
1353909|NCT01747629|Secondary|Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||hour||Full Range|Median
1353910|NCT01747629|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg/mL||Standard Deviation|Mean
1353911|NCT01747629|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).~Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:~Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Days 8 and 85|Safety analysis set|||participants|||Number
1353912|NCT01747629|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint. HEENT = head, eyes, ears, nose, throat.|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized.|||participants|||Number
1353913|NCT01747629|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 93|Safety analysis set|||participants|||Number
1353914|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
1353915|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
1353916|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set|||L*hr||95% Confidence Interval|Mean
1353917|NCT01747629|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set included all participants in the intent-to-treat population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.|||L*hr||Standard Error|Mean
1353918|NCT01747551|Secondary|Duration of Objective Response|Duration of response is the time from date of first documented confirmed objective response to date of first documented progressive disease. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up (months) median (range) was 14.5 (1.1-49.8) and 18.8 (0.6-49.8) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively.|The analysis dataset is comprised of patients who achieved objective response except one patient on the mFOLFOX6+Placebo is missing data.|||months||Full Range|Mean
1353949|NCT01746511|Secondary|Rate of Decline in Bilirubin Levels (mg/dL/hr)|Absolute change over time from peak to first discontinuation of phototherapy lights|from time of enrollment to time of discharge, for a maximum of 10 weeks||||mg/dL/hr||Standard Deviation|Mean
1353950|NCT01746511|Secondary|Peak Total Serum Bilirubin Level|Bilirubin levels were checked every 12 hours while the infant was under phototherapy. A bilirubin level was then to be checked at least twice, 8-12 hours or longer apart, following discontinuation of phototherapy.|from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks||||mg/dL||Standard Deviation|Mean
1353919|NCT01747551|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patients received a median (range) treatment duration (m) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively.|The analysis dataset is comprised of all patients with measurable disease at baseline.|||percentage of patients||95% Confidence Interval|Number
1353920|NCT01747551|Secondary|Grade 4 Treatment-Related Toxicity Rate|The percentage of patients who experienced maximum grade 4 treatment-related adverse event based on CTCAEv4 as reported on case report forms.|Adverse events were collected each cycle on treatment. Patients received a median (range) treatment duration (months) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively.||||percentage of participants||95% Confidence Interval|Number
1353921|NCT01747551|Primary|6-month Progression-free Survival (PFS)|6-month PFS is the percent probability of patients remaining alive and progression-free at 6-months from randomization estimated using Kaplan-Meier methods. PFS was measured as the time from randomization to 1st documented disease progression (PD) or death. Patients alive without PD were censored at the earliest of the date of last progression-free disease assessment or start of non-protocol therapy. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up was 6 months.|The analysis dataset is comprised of all randomized patients.|||percent probability||95% Confidence Interval|Number
1353922|NCT01747343|Other Pre-specified|Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children||2 months minus baseline||||Self-initiations||Standard Deviation|Mean
1353923|NCT01747343|Secondary|Change in the Mean Percentage of Appropriate Eliminations Across Children||2 months minus baseline||||Percentage of opportunities||Standard Deviation|Mean
1353924|NCT01747343|Primary|Change in the Mean Number of Accidents Across Children||2 months minus baseline||||Accidents||Standard Deviation|Mean
1353925|NCT01747330|Secondary|Number of Participants With Clinical Relevant Safety Laboratory Values|(hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)|3 months|Full Analysis subject sample|||participants|||Number
1353926|NCT01747330|Secondary|Number of Participants With Findings During Physical Examination|A physical examination was conducted by the physician. All abnormal findings were recorded as medical histories if present prior to start of study drug or as AEs otherwise. There was no separate documentation of physical examination findings in this study.|3 months|Full Analysis subject sample|||participants|||Number
1353927|NCT01747330|Secondary|Pulse|Change from Baseline at Day 84|3 months||||bpm||Standard Deviation|Mean
1353928|NCT01747330|Secondary|Number of Subjects With Adverse Events||4 months|Full Analysis subject sample|||participants|||Number
1353929|NCT01747330|Primary|Subject's Acceptance of Treatment|Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.|3 months|Full Analysis subject sample|||percentage of participants|||Number
1353930|NCT01747330|Primary|Stool Consistency|Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery|3 months|Full Analysis subject sample|||% of days with normal stool consistency||Standard Deviation|Mean
1353931|NCT01747330|Primary|Stool Frequency|Average daily stool frequency during treatment period: Number of bowel movements per day|3 months|Full Analysis subject sample|||Bowel movements per day||Standard Deviation|Mean
1353932|NCT01747330|Primary|Height|change from baseline at day 84|3 months|Full Analysis subject sample|||m||Standard Deviation|Mean
1353933|NCT01747330|Primary|Body Weight|change from baseline at day 84|3 months|Full Analysis subject sample|||kg||Standard Deviation|Mean
1353934|NCT01746979|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years||||months||95% Confidence Interval|Median
1353935|NCT01746979|Primary|Overall Survival|Overall survival is defined as time from randomization to death or last day known to be alive.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years||||months||95% Confidence Interval|Median
1353951|NCT01746511|Secondary|Number of Episodes of Repeat Phototherapy|"Bilirubin levels are checked at regular intervals after phototherapy is discontinued to make sure levels are safe. Depending on rate of rise and predetermined unsafe bilirubin level, phototherapy may be restarted."|from time of enrollment to time of discharge, for a maximum of 10 weeks||||episodes of repeat phototherapy||Full Range|Median
1353952|NCT01746511|Primary|Total Number of Hours of Required Phototherapy||from time of enrollment to time of discharge, for a maximum of 10 weeks||||hours||Standard Deviation|Mean
1353969|NCT01746264|Secondary|25-hydroxy Vitamin D (25[OH]D) Levels|25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Total 25(OH)D concentrations of each sample was calculated using internal standard, 25(OH)D_2 and 25(OH)D_3.|baseline, 3 months||||nmol/L||Standard Deviation|Mean
1353936|NCT01746940|Primary|Immediate and Sustained Analgesic Success|The primary endpoint for this trial is analgesic success immediately after application of study drug and sustained throughout the diagnostic procedure or surgery for each nostril that received the study drug application. A subject will be considered a treatment success if they meet the following: Prior to the procedure or surgery, a 0 pain score on the 10 point pain scale (0=no pain, 10=unbearable pain) based on the Von Frey filament challenge after application of the assigned treatment solution (placebo, 4% or 10% Cocaine HCl). During the procedure or surgery, no further analgesic treatment is required (only 4% and 10% Cocaine HCl subjects who receive a procedure or surgery). Otherwise, the subject will be considered a treatment failure. Subjects with missing primary outcome data are marked as treatment failures in all treatment groups.|Prior to and During a one-day Surgery or Diagnostic Procedure|The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug and who are enrolled in the safety and efficacy phase of the study.|||proportion of particpants analyzed||95% Confidence Interval|Number
1353937|NCT01746862|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. For the Saizen Test Group, TEAEs were defined as events that occurred or worsened at or after the first administration of treatment and for the Saizen Control Group, TEAEs were defined as events that occurred or worsened at or after the randomization.|Baseline up to Month 13|Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.|||subjects|||Number
1353938|NCT01746862|Secondary|Percentage of Adherence to Study Treatment|Percentage of adherence to study treatment (adherence rate) was defined as the actual number of received treatments divided by the scheduled number of treatments multiplied by 100. The adherence rate for 6 months was calculated from Baseline to 6 months for the Saizen Test Group and from Month 6 to Month 12 for the Saizen Control Group.|6 months post-dose (Saizen Test Group and Saizen Control Group); 12 months post-dose (Saizen Test Group)|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||percentage of adherance||Standard Deviation|Mean
1353939|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||mcg/L||Standard Deviation|Mean
1353940|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||microgram/liter (mcg/L)||Standard Deviation|Mean
1353941|NCT01746862|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12|Height SDS was calculated as: Height SDS = (measured height – population mean) / population standard deviation, where mean and standard deviation were based on the Korean standard growth charts. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject’s value was relative to the mean of the reference population. The scores were centred around zero. Negative score indicated a subject was smaller for their age/gender.|Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||standard deviation score||Standard Deviation|Mean
1353942|NCT01746862|Secondary|Change From Baseline in Height at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||centimeter (cm)||Standard Deviation|Mean
1353943|NCT01746862|Secondary|Change From Baseline in Height Velocity at Month 12|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 12 months prior] / 12) * 12. Height velocity at Month 12 = ([Month 12 height minus height measurement obtained at least 12 months prior] / 12) * 12.|Baseline, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||cm/year||Standard Deviation|Mean
1353944|NCT01746862|Primary|Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 6 months prior] / 6) * 12. Height velocity at Month 6 = ([Month 6 height minus height measurement obtained at least 6 months prior] / 6) * 12.|Baseline, Month 6|Intent-to-treat (ITT) analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||centimeter/year (cm/yr)||Standard Deviation|Mean
1353953|NCT01746368|Secondary|Satisfaction|"Score on the Client Satisfaction Questionnaire-8 (CSQ-8). The overall score is produced by summing all item responses. For the CSQ-8, scores range from 8 to 32, with higher values indicating higher satisfaction.~Response options differ from item to item, but all are based on a four-point scale.~All items are positively worded; however, the directionality of response options span the spectrum from very negative to very positive; and, the numerical anchors for items are reversed randomly (from high to low or low to high) from item to item to minimize stereotypic response sets. The CSQ-8 has no subscales and reports a single score measuring a single dimension of overall satisfaction."|For participants who received the allocated intervention, up to one month after intervention; for all others, up to 90 days after consenting to the study.||||Scores on a scale||Standard Deviation|Mean
1353954|NCT01746368|Primary|Number of Participants Who Completed an Advance Directive|An advance directive was considered completed upon confirmation of the scanned document in the medical record.|Up to 1 month after intervention|intention to treat (ITT)|||participants|||Number
1353955|NCT01746264|Secondary|Reactive Hyperemia Index (RHI)|The cuff of a sphygmomanometer was placed on the forearm and inflated to 50 mm Hg above the participant’s systolic blood pressure for a period of 5 min. The increase in resting brachial blood flow was calculated as the maximum flow recorded in the first 15 seconds after cuff deflation and expressed as a percentage increase from baseline reactive. Higher values are considered normal or improved endothelial function.|baseline, 3 months|Data for one subject could not be included as the data on RHI was lost in the system and could not be retrieved.|||percentage increase in blood flow||Standard Deviation|Mean
1353956|NCT01746264|Secondary|Urine Calcium to Creatinine Ratio|Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.|baseline, 3 months||||mg/g||Standard Deviation|Mean
1353957|NCT01746264|Secondary|High Density Lipoprotein (HDL) Cholesterol Levels|Total HDL cholesterol levels were measured by an enzymatic colorimetric assay. The test for high-density lipoprotein cholesterol (HDL-C) is used along with other lipid tests to screen for unhealthy levels of lipids and to determine the risk of developing heart disease. If a subject has a negative risk factor, a desirable HDL level would be >/= 1.55 mmol/L.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
1353958|NCT01746264|Secondary|Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels|The test for low-density lipoprotein cholesterol is used as part of a lipid profile to predict an individual's risk of developing heart disease. A desirable level is <3.36 mmol/L; borderline high is 3.36 - 4.11 mmol/L; high is >/= 4.14 mmol/L. LDL cholesterol was calculated as: LDL = Total cholesterol - HDL cholesterol - Triglycerides/5.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
1353959|NCT01746264|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|A high-sensitivity C-reactive protein (hs-CRP) test may be used to help evaluate an individual for risk of cardiovascular disease (CVD). C-reactive protein (CRP) is a protein that increases in the blood with inflammation. Studies have suggested that a persistent low level of inflammation plays a major role in atherosclerosis, the narrowing of blood vessels due to build-up of cholesterol and other lipids, which is often associated with CVD. The hs-CRP test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation and thus helps predict a person's risk of developing CVD. hs-CRP was measured using particle-enhanced immunonephelometry.|baseline, 3 months||||nmol/L||Standard Deviation|Mean
1353960|NCT01746264|Secondary|Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)|This calculation measures insulin resistance, and requires U.S. standard units. The healthy range is 0.5 to 1.4. Less than 1.0 means the subject is insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. The HOMA-IR was calculated as: HOMA-IR = fasting serum glucose (mmol/L) x fasting insulin (mU/mL)/22.5.|baseline, 3 months||||index of beta cell function||Standard Deviation|Mean
1353961|NCT01746264|Secondary|Fasting Insulin|Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.|baseline, 3 months||||pmol/L||Standard Deviation|Mean
1353962|NCT01746264|Secondary|Fasting Glucose|Plasma glucose was measured by hexokinase enzymatic assay.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
1353963|NCT01746264|Secondary|Serum Parathyroid Hormone (PTH)|A parathyroid hormone (PTH) blood test measures the level of parathyroid hormone in the blood. This test is used to help identify hyperparathyroidism, to find the cause of abnormal calcium levels, or to check the status of chronic kidney disease. PTH controls calcium and phosphorus levels in the blood. PTH was measured by a two-site chemiluminescent immunometric assay.|baseline, 3 months||||pmol/L||Standard Deviation|Mean
1353964|NCT01746264|Secondary|Calcium Intake Per Day|Calcium intake was measured using the validated Short Calcium Questionnaire (SCQ). This questionnaire is in the form of an spreadsheet, and asks the participant to enter the number of servings per week of various food items and vitamin or mineral supplements. The spreadsheet calculates the daily calcium intake (mg/day) from the data entered.|baseline, 3 months||||mg/day||Standard Deviation|Mean
1353965|NCT01746264|Secondary|International Physical Activity Questionnaire (IPAQ) Short Form Score|The IPAQ short form used asked 7 questions about activities in the last 7 days, covering vigorous physical activities, moderate activities, walking, and sitting, asking for days per week, hours per day or minutes per day. The score is reported in metabolic equivalent (MET)-minutes per week. Possible scores could range from 0 (inactive) to greater than 3000 MET-minutes/week (highly active). The definition of high activity was vigorous intensity activity on at least 3 days achieving a minimum total activity of at least 1500 MET-minutes/week OR 7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 MET-minutes/week. Therefore a score of > 3000 MET-minutes/week was possible.|baseline, 3 months||||MET-minutes per week||Standard Deviation|Mean
1353966|NCT01746264|Secondary|Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.|baseline, 3 months||||kg/m^2||Standard Deviation|Mean
1353967|NCT01746264|Secondary|Triglycerides|Total triglyceride levels were measured by an enzymatic colorimetric assay.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
1353970|NCT01746264|Primary|Flow Mediated Dilatation (FMD)|Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.|baseline, 3 months|Data for one subject could not be included as the data on FMD was lost in the system and could not be retrieved.|||percentage increase in BAD||Standard Deviation|Mean
1353971|NCT01746173|Secondary|Induction Response|Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Reponse was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.|Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).||||proportion of patients||90% Confidence Interval|Number
1353972|NCT01746173|Primary|24-month Progression-Free Survival Rate|24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).|Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.|The analysis dataset is comprised all enrolled patients.|||proportion of patients||90% Confidence Interval|Number
1353973|NCT01746108|Secondary|Concentrations of Antibodies Against Protein D (PD) in the Healthy Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1353974|NCT01746108|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. When number of subjects analysed = 1, Lower limit and Upper Limit values were entered as equal to the Geometric mean value. “999999.9” was used as placeholder when Upper Limit value was greater than “1.0E8”.|One month after Dose 1 (At Month 1) and/or one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1353975|NCT01746108|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1353976|NCT01746108|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of study subjects|From Dose 1 at Month 0 up to study end at Month 1 for primed subjects and at Month 3 for unprimed subjects.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353977|NCT01746108|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post- vaccination period|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353978|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353998|NCT01745952|Secondary|Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment|Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.|week 12 after each treatment|baseline weekly seizure frequency over all participants was 24.8 (95% confidence interval 8.2-76.1)|||seizures/week||95% Confidence Interval|Mean
1353979|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353980|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353981|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353982|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353983|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain =Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353984|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353985|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1353986|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1353987|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1353999|NCT01745952|Primary|50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment|Number of participants achieving a 50% or greater reduction in seizure frequency from baseline|week 12 after each intervention||||participants|Participants||Number
1354000|NCT01745913|Secondary|Severity of Opportunistic Infections||estimation of 24 months to obtain infection data on all subjects|Data were not collected||||||
1354001|NCT01745913|Secondary|Incidence of Acute and Chronic GVHD||estimation of 24 months to obtain GVHD data on all subjects|Data were not collected||||||
1353988|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was~≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1353989|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was~≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1353990|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A,~-19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1353991|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1353992|NCT01746043|Primary|Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.|Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores|Baseline, 6 weeks|Of the 21 randomized patients , 19 (90% were evaluable for the primary efficacy analysis).|||Participants|||Count of Participants
1353993|NCT01745952|Other Pre-specified|Adverse Event Rate||during the 9 months of the study||||participants|||Number
1353994|NCT01745952|Other Pre-specified|Drop Out-rate|exclusion by investigator was due to necessity to change drug regimen due to toxicity|during the 9 months of the study|for this analysis, all patients randomised were included; this includes one patient in the second arm that was not included in any of the other outcome measures, due to lack of reliable outcome parameters|||participants|||Number
1353995|NCT01745952|Other Pre-specified|Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale|"Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life.~Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment~Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk~change in QOLIE scores considered better/worse are based on cut-off reported in DOI 10.1016/j.yebeh.2011.12.023 For global impression of change, the scoring was <4, 4 or >4."|before the first treatment of each session and at the last evaluation visit|* Self-reporting questionnaires could only be filled in by 7 participants For global impression of change scales, the score reached by consensus between the patient and caregiver(s) was used if patient was unable to fill in questionaires: for the three arms, we thus have 7/8/6 scores for each arm respectively|||participants|||Number
1353996|NCT01745952|Other Pre-specified|Difference in Seizure Reduction Using Different Coil Types|any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data|9 months|averaged weekly seizure count per condition is given for all patients combined|||number of seizures per week||95% Confidence Interval|Mean
1353997|NCT01745952|Other Pre-specified|Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level|Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.|within one week after the last treatment day of each session|"patients of whom seizure journals were incomplete also included (one participant who went through all 3 trials and one patient of whom journals were not available from the sham session, that was reported by the patient as ineffective)"|||participants|||Number
1354004|NCT01745913|Secondary|Platelet Recovery After Transplant Regimens|No patients completed this study and are therefore inevaluable|estimation of 24 months to determine platelet recovery for all subjects|Data not collected. Patients died.||||||
1354005|NCT01745913|Primary|Rate of Neutrophil Engraftment After Combined Haplo-identical Cord With That of Umbilical Cord Blood Transplantation.|No patients completed this study and are therefore inevaluable. Subject data not evaluable for the outcome measure time frame. Subject data only evaluable up to month 3.|estimation of 24 months to determine engraftment rates for all subjects|Data not collected. Patients died.||||||
1354006|NCT01745848|Secondary|Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation|Participants had flow mediated dilation of the brachial artery measured at the baseline visit and at the follow-up visit after receiving 30 days of roflumilast 500 mcg daily. An ultrasound probe was placed over the brachial artery and the brachial artery diameter was measured in real time. A blood pressure cuff positioned below the elbow was then inflated to 50 mmHg above systolic pressure for five minutes. After five minutes of occlusion, the blood pressure cuff was released and the brachial artery diameter was again measured in real time. The amount of dilation expressed as the absolute change, in millimeters, from baseline diameter was quantified using the ultrasound images obtained 60 seconds after cuff release.|30 days - measured at baseline and 30 days|Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.|||millimeters||Standard Deviation|Mean
1354007|NCT01745848|Primary|Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP))|Serum samples were obtained at baseline and after participants took a once daily, 500 mcg roflumilast dose for 30 days. Samples were obtained in the semi-fasting state, processed, and stored for batch analysis at the end of the study. C-terminal peptide of type 1 collagen (CTx), a marker of bone resorption, was analyzed using a commercially available immunoassay (Roche Elecsys 2010 analyzer, Roche Diagnostics, Manheim, Germany). Serum amino-terminal propeptide of type-1 procollagen (P1NP) was measured by ELISA (MyBioSource, San Diego, CA). All assays were performed according to the manufacturers’ instructions.|30 days - measurements at baseline and 30 days|Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.|||ng/mL||Standard Deviation|Mean
1354008|NCT01745393|Secondary|Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence|When a participant reports smoking abstinence, we will bioverify their smoking status.|up to 12 months||||Participants|||Count of Participants
1354009|NCT01745393|Primary|Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources|Parental report of cigarettes child is exposed to each day in the home and car by all sources during the 7 days prior to assessment. We anticipate the CQI+BC treatment group will report greater reductions in second-hand smoke exposure over time than the CQI+A control group.|up to 12 months||||cigarettes exposed per day||Standard Deviation|Mean
1354010|NCT01745393|Primary|Child Urine Cotinine|Child urine cotinine is a biomarker for assessing second-hand smoke exposure. We anticipate the CQI+BC treatment group will experience a greater reduction in child urine cotinine over time than the CQI+A control group.|up to 12 months|The fewer number of units analyzed compared to participants analyzed relates to completion of telephone assessments for all participants, but inability to collect 5 urine samples in the Behavioral Counseling group and 2 urine samples in the Attention Control group at the post-phone assessment urine pickup at participants' homes.|||log transformed ng/mL|urine cotinine samples|Standard Deviation|Mean
1354011|NCT01745380|Other Pre-specified|Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia.|at 25 minutes, +3 minute window|This analysis is only of the participants who received 3 sprays. It does not include participants who only received 2 sprays.|||participants|||Number
1354012|NCT01745380|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1354013|NCT01745380|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1354014|NCT01745380|Secondary|Alcohol Sniff Test|The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on a cotton ball.|administered at approximately 24 hours after drug administration||||cm||Standard Deviation|Mean
1354015|NCT01745380|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration||||beats per minute||Standard Deviation|Mean
1354016|NCT01745380|Secondary|Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1354017|NCT01745380|Secondary|Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1354018|NCT01745380|Secondary|Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
1354019|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg||at any time within 120 minutes following study drug administration||||participants|||Number
1354020|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg||at any time within 120 minutes following study drug administration||||participants|||Number
1354021|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg||at any time within 120 minutes following study drug administration||||participants|||Number
1354022|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration||||participants|||Number
1354025|NCT01745380|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older.|at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used|Participants were only analyzed in their corresponding age group.|||percentage of participants|||Number
1354026|NCT01745380|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 15 minutes, +3 minute window||||participants|||Number
1354027|NCT01745133|Primary|Physician Global Assessement|"Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear~= almost clear~= mild~= moderate~= severe"|10 weeks||||percentage of patients|||Number
1354028|NCT01745094|Secondary|Change From Baseline in Postvoid Residual (PVR) Volume|Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.|Baseline and week 4, 8, 12, 16|SAF|||mL||Standard Deviation|Mean
1354029|NCT01745094|Secondary|Change From Baseline in the Number of Nocturia Episodes Per Night|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||nocturia episodes||Standard Deviation|Mean
1354030|NCT01745094|Secondary|Change From Baseline in the Volume Voided Per Micturition|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis."|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||mL||Standard Deviation|Mean
1354031|NCT01745094|Secondary|Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence’ were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||urge incontinence episodes||Standard Deviation|Mean
1354032|NCT01745094|Secondary|Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours|Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.|Week 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
1354033|NCT01745094|Secondary|Change From Baseline in the Number of Incontinence Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence’ was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||incontinence episodes||Standard Deviation|Mean
1354034|NCT01745094|Secondary|Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours|Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.|Week 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
1354046|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550||0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||milligram||Standard Deviation|Mean
1354035|NCT01745094|Secondary|Change From Baseline in the Number of Urgency Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||urgency episodes||Standard Deviation|Mean
1354036|NCT01745094|Secondary|Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours|Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours.|Week 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
1354037|NCT01745094|Secondary|Change From Baseline in the Number of Micturitions Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||micturitions||Standard Deviation|Mean
1354038|NCT01745094|Secondary|Change From Baseline in OAB-q SF Total HRQL Score|The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||units on a scale||Standard Deviation|Mean
1354039|NCT01745094|Secondary|Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score|The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||units on a scale||Standard Deviation|Mean
1354040|NCT01745094|Secondary|Number of Participants Who Achieved Normalization for OABSS Total Score|Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.|Week 8 and 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
1354041|NCT01745094|Secondary|Change From Baseline in OABSS Total Score|The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||units on a scale||Standard Deviation|Mean
1354042|NCT01745094|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.|From first dose of study drug up to weeks 16|SAF|||Participants|||Count of Participants
1354043|NCT01745055|Secondary|Renal Clearance (CL R) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||L/hr||Standard Deviation|Mean
1354044|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||milligram||Standard Deviation|Mean
1354045|NCT01745055|Secondary|Renal Clearance (CL R) for CP-690,550||0 (pre-dose) through 24 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||litre/hour (L/hr)||Standard Deviation|Mean
1354313|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|Baseline||||units on a scale||Standard Error|Mean
1354047|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for Methotrexate (MTX)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||mL/hr||Standard Deviation|Mean
1354048|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for Methotrexate (MTX)|Plasma decay half-life is the time measured for the plasma concentration of MTX to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Standard Deviation|Mean
1354049|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 ,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Full Range|Median
1354050|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for CP-690,550|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||mL/hr||Standard Deviation|Mean
1354051|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for CP-690,550|Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Standard Deviation|Mean
1354052|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Full Range|Median
1354053|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||ng/mL||Standard Deviation|Mean
1354054|NCT01745055|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||ng*hr/mL||Standard Deviation|Mean
1354055|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||ng/mL||Standard Deviation|Mean
1354056|NCT01745055|Primary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550|AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The pharmacokinetic (PK) analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1354057|NCT01744977|Secondary|Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months|obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months)|Baseline, 6months, 12months|Cholesterol values could not be obtained for all patients at all time points.|||mg/dL||Standard Deviation|Mean
1354058|NCT01744977|Primary|Cholesterol Medication Adherence|Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups|12 months|Data on pill refill could not be obtained for 2 of the education only participants.|||adherence proportion||Inter-Quartile Range|Median
1354059|NCT01744860|Secondary|Management of Discordance-Final Result for BRAF V600 Mutation Detection|The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."|||number of samples|Participants||Number
1354060|NCT01744860|Secondary|Management of Discordance- Method Used to Manage Discordance|"Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor [prm. tmr]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between in-house method and Cobas 4800 mutation test."|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."|||number of samples|Participants||Number
1354061|NCT01744860|Secondary|Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method|This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||hours|Participants|Full Range|Median
1354062|NCT01744860|Secondary|Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method|This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||days|Participants|Full Range|Median
1354063|NCT01744860|Secondary|Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was No=375, was used for analysis.|||number of samples|Participants|Standard Deviation|Mean
1354064|NCT01744860|Secondary|Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354065|NCT01744860|Secondary|Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method|The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||ng/mcl|Participants|Standard Deviation|Mean
1354066|NCT01744860|Secondary|Technician Work Time Between DNA Extraction and Result by “In-house” Analytical Method|The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||hours|Participants|Full Range|Median
1354067|NCT01744860|Secondary|Median Time Between Receipt of Samples and Determination of Result by “In-house” Analytical Method|This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||days|Participants|Full Range|Median
1354068|NCT01744860|Secondary|Mean Number of Slices Per Sample Used for “In-house”- Analytical Method|The mean of number of slices per sample when no punch was used are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was not used were considered for analysis.|||number of samples|Participants|Standard Deviation|Mean
1354069|NCT01744860|Secondary|Number of Samples Punched in In-house Analytical Method|Total number of samples for whom punch was used in 'in-house analytical' method are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354070|NCT01744860|Secondary|Method of Mutation Detection by “In-house” Analytical Method|Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354071|NCT01744860|Secondary|Size of Amplicons Used by “In-house” Analytical Method|The method described the size of amplicon used. It was measured in base pairs (bp).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||bp|Participants|Full Range|Median
1354072|NCT01744860|Secondary|Amount of DNA by Pre-analytical Method|The total DNA concentration extracted from the tissue was measured in nanogram (ng).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||ng|Participants|Standard Deviation|Mean
1354073|NCT01744860|Secondary|Mean DNA Concentration by Pre-analytical Method|The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||ng/mcl|Participants|Standard Deviation|Mean
1354074|NCT01744860|Secondary|Median DNA Elution Volume by Pre-analytical Method|Median DNA elution volume microliters [mcl] was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||mcl|Participants|Full Range|Median
1354075|NCT01744860|Secondary|DNA Extraction – Extraction Method by Pre-analytical Method|This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354076|NCT01744860|Secondary|Tumor Samples With Presence of Melanin by Pre-analytical Method|The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only available samples were included for analysis.|||number of samples|Participants||Number
1354077|NCT01744860|Secondary|Percentage of Tumor Cells by Pre-analytical Method|The percentage of tumor cells in the given tumor sample were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||percentage|Participants|Standard Deviation|Mean
1354078|NCT01744860|Secondary|Necrosis Percentage Determination by Pre-analytical Method|The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only 341 samples out of 420 were analysed as the information on presence of necrosis was missing for 79 samples in the assessed zones.|||percentage|Participants|Standard Deviation|Mean
1354079|NCT01744860|Secondary|Dewaxing by Pre-analytical Method|Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as “Yes, No or Missing”|Up to 6 Months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354080|NCT01744860|Secondary|Slice Thickness by Pre-analytical Method|Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||micrometer (µm)|Participants|Standard Deviation|Mean
1354081|NCT01744860|Secondary|Fixation Duration by Pre-analytical Method|Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as <6 hours, 6-24 hours and >24 hours and unknown. Number of samples falling in each category were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354082|NCT01744860|Secondary|Type of Fixative Used- Pre-analytical Method|The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354083|NCT01744860|Secondary|Time From Sampling to Fixation- Pre-analytical Method|Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, >6 hours and unknown. Number of samples falling in each of the class were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354084|NCT01744860|Secondary|Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method|The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354085|NCT01744860|Secondary|Tumor Sample Characteristics - Source of Tumor Sample|The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
1354086|NCT01744860|Secondary|Tumor Sample Characteristics-Type of Tumor Sample|The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis|||number of samples|Participants||Number
1354087|NCT01744860|Primary|BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories|"BRAF V600 mutation status was determined by INCa molecular laboratories “in-house” methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory in-house method."|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. n = number of samples with BRAF V600 mutation by “in-house method”.|||number of samples|Participants||Number
1354088|NCT01744821|Secondary|Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.|Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D|Up to 24 months||||participants|||Number
1354089|NCT01744821|Secondary|Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers|"The outcomes that will be measured for the secondary objectives of this study will include the following:~Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24"|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.||||||
1354090|NCT01744821|Primary|Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Decrease in cellular proliferation measured by immunohistochemistry staining with KI67|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.||||||
1354091|NCT01744821|Primary|The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical.|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.||||||
1354092|NCT01744782|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Cysteamine|Blood samples were collected and plasma cysteamine concentration was determined using liquid chromatography. AUC values were estimated using non-compartmental analysis methods. AUClast was defined as the area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (720 minutes). AUCinf was defined as the area under the plasma concentration-versus-time curve from time 0 to infinity.|30 minutes after the morning RP103 dose at Month 6 (prior to Protocol Amendment 1) or 0 (pre-dose), 30 minutes, 2, 3, 4, 6, 8, 10, and 12 hours after the morning RP103 dose at Month 6 for those enrolled under Protocol Amendment 1 or later|Participants age <6 years who received at least 1 dose of RP103 and participated in frequent sampling at the Month 6 visit.|||min*mg/L||Standard Deviation|Mean
1354093|NCT01744782|Secondary|Time of the Maximum Observed Plasma Concentration (Tmax) of Cysteamine|Blood samples were collected and plasma cysteamine concentration was determined using liquid chromatography. The time of the maximum observed plasma concentration (Tmax) of cysteamine was determined directly from the data.|30 minutes after the morning RP103 dose at Month 6 (prior to Protocol Amendment 1) or 0 (pre-dose), 30 minutes, 2, 3, 4, 6, 8, 10, and 12 hours after the morning RP103 dose at Month 6 for those enrolled under Protocol Amendment 1 or later|Participants age <6 years who received at least 1 dose of RP103 and participated in frequent sampling at the Month 6 visit.|||minutes||Standard Deviation|Mean
1354094|NCT01744782|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cysteamine|Blood samples were collected and plasma cysteamine concentration was determined using liquid chromatography. The maximum observed plasma concentration (Cmax) of cysteamine was determined directly from the data.|30 minutes after the morning RP103 dose at Month 6 (prior to Protocol Amendment 1) or 0 (pre-dose), 30 minutes, 2, 3, 4, 6, 8, 10, and 12 hours after the morning RP103 dose at Month 6 for those enrolled under Protocol Amendment 1 or later|Participants age <6 years who received at least 1 dose of RP103 and participated in frequent sampling at the Month 6 visit.|||mg/L||Standard Deviation|Mean
1354095|NCT01744782|Secondary|Number of Participants With Adverse Events|Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). An AE/adverse experience was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. For additional information regarding adverse events, please see the safety section of the record.|Day 1 through study exit|Safety population: All participants who received at least 1 dose of RP103.|||Participants|||Count of Participants
1354096|NCT01744782|Primary|Mean White Blood Cell (WBC) Cystine Concentration at Each Visit|Blood samples were taken 30 minutes after the morning RP103 dose at each study visit to determine White Blood Cell (WBC) cystine concentration. WBC cystine concentrations were determined using liquid chromatography.|Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Month 6, Month 9, Month 12, Month 15, Month 18, Study Exit|Participants <6 years of age who received at least 1 dose of RP103 and who had at least 1 WBC cystine level recorded.|||nmol 1/2 Cystine/mg protein||Standard Deviation|Mean
1354097|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese & non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below.~Sampling schedule details for PTN_POPS & Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/kg||Full Range|Median
1354098|NCT01744730|Post-Hoc|Half-life|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for half-life by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After participant transitioned from IV Clindamycin to oral Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||hours||Full Range|Median
1354099|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L||Full Range|Median
1354112|NCT01744483|Primary|Percentage of Patients With Tracheal Bacterial Colonization|The percentage of patients with quantitative culture growth from tracheal aspirate specimens of >1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.|Tracheal colonization by Day 4 or extubation||||percentage of tracheal colonization|||Number
1354113|NCT01744392|Secondary|Pulse at 6 Months|Clinical Characteristics at 6 month for Pulse|6 months||||beats per minute||Standard Deviation|Mean
1354114|NCT01744392|Secondary|Pulse at Baseline|Clinical Characteristics at Baseline for Pulse|baseline||||beats per minute||Standard Deviation|Mean
1354115|NCT01744392|Secondary|Weight at 6 Months|Clinical Characteristics at 6 months for Weight|6 months||||pounds||Standard Deviation|Mean
1354116|NCT01744392|Secondary|Weight at Baseline|Clinical Characteristics at Baseline for Weight|baseline||||pounds||Standard Deviation|Mean
1354100|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/h/70 kg||Full Range|Median
1354101|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/h/kg||Full Range|Median
1354102|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/h||Full Range|Median
1354103|NCT01744691|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population.|||participants|||Number
1354104|NCT01744691|Primary|Overall Response Rate|The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.|The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months|Efficacy analyses were performed on all 144 treated subjects. The primary analysis (PA) used IRC assessment of efficacy endpoints. In the PA, there were no differences between the IRC and investigator responses. IRC assessment was no longer performed after the PA and the final analysis result report investigator-assessed efficacy outcomes.|||% of participants with response by PI||95% Confidence Interval|Number
1354105|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease|"The classification of pain in Parkinson’s disease scale classifies pain in the following domains: musculoskeletal pain (item 1), chronic pain (items 2 and 3), fluctuation related pain (items 4, 5 and 6), nocturnal pain (items 7 and 8), oro-facial pain (items 9, 10 and 11), discoloration; edema/swelling (items 12 and 13), and radicular pain (item 14). Severity of the pain is measured on a scale from none (0) to severe (3) and frequency is measured on a scale from never (0) to very frequent (4).~A score of a single item was calculated by multiplying severity with frequency. A domain score was calculated as the sum of every individual score related to the respective domain. A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
1354117|NCT01744392|Secondary|Cholesterol & Creatinine Levels at 6 Months|Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine|6 months||||mg/dL||Standard Deviation|Mean
1354106|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject’s activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
1354107|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
1354108|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
1354109|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
1354110|NCT01744496|Secondary|Percentage of Responders at the End of the Maintenance Period|Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||percentage of responders|||Number
1354111|NCT01744496|Primary|Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale|"An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).~The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit – 7 days). A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
1354118|NCT01744392|Secondary|Cholesterol & Creatinine Levels at Baseline|Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine|baseline||||mg/dL||Standard Deviation|Mean
1354121|NCT01744392|Primary|Medication Possession Ratio at 6 Months|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for 6 months MPR 6 months after enrollment."|6 months||||percentage of medication possession||Standard Deviation|Mean
1354122|NCT01744392|Primary|Medication Possession Ratio at Baseline|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for baseline MPR 12 months prior to enrollment."|baseline||||percentage of medication possession||Standard Deviation|Mean
1354123|NCT01744353|Secondary|Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.|Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters|pre-drug until disease progression, whichever comes first, for an expected average of 6 months||||participants|||Number
1354124|NCT01744353|Primary|Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.|MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.|For up to 30 days post completing drug, an expected average of 6 months||||participants|||Number
1354125|NCT01744340|Secondary|Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.|"This shows patients able to achieve Stable disease or better as their best response during course of study participation. Response will be evaluated by Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1 RECIST Guideline version 1.1 Response Criteria Complete Response:Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|From beginning of treatment to progression of disease, for an expected average of 1 year||||participants|||Number
1354126|NCT01744340|Primary|If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer.|"A DLT was defined as:~Grade 4 neutropenia (ANC < 500/mm3) for > 7 days~ANC <1000/mm3 with fever or infection~Platelets <25,000/mm3~Platelets <50,000/mm3 requiring transfusion~Grade 3 or grade 4 treatment related non-hematologic toxicities excluding alopecia. Grade 3 nausea, vomiting or diarrhea will only be considered a dose limiting toxicity if it occurs despite maximal medical support. Grade 3 or grade 4 hypomagnesemia will not be considered a dose limiting toxicity since it is an expected side effect of cetuximab and can be corrected. Other grade 3 or grade 4 electrolyte abnormalities will not be considered dose limiting toxicities if the electrolyte disorder can be corrected to grade 2 or less within 72 hours.~EGFR dermatologic toxicity should be graded according to the toxicity scale for EGFR associated reactions. The first episode of grade 3 or grade 4 rash will not be considered a DLT.~If any patient receives < 70% of the planned dose of eribulin mesylat"|From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days|Outcome measure that address the dose of 1.4 mg/m2,6 patients were treated (1 head and neck 5 colon). 12 patients were enrolled in the course of the MTD dose finding,10 colon and 2 head and neck. All other results sections are inclusive of all patients(dose finding +expansion cohort).|||participants|||Number
1354127|NCT01744197|Secondary|Global Assessment of Satisfaction With Venipuncture|Rates of Satisfied and very satisfied are used to be compared between two groups.|30 minutes after the venipuncture.|Normal completion patients|||percentage of participants|||Number
1354128|NCT01744197|Primary|Percentage of Patients With No Pain (VAS=0)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients|||percentage of participants|||Number
1354129|NCT01744197|Primary|Percentage of Patients With No or Minor Pain (VAS<3)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients.|||percentage of participants|||Number
1354130|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months|||||||
1354131|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months|||||||
1354132|NCT01743963|Secondary|Feasibility/Reach/Adoption|"Measurements of intervention delivery include the representativeness of providers (differences between participants/non-participants). Results reported using descriptive statistics (proportions, means, standard deviations, and ranges)."|12 months|||||||
1354133|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include recruitment numbers and provider Participation Rates for enrollment and retention. The definition of study feasibility consists of provider enrollment rates >= 50%. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months|||||||
1354308|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Baseline||||units on a scale||Standard Error|Mean
1354134|NCT01743963|Primary|Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).|For follow-up laboratory data within the VA system, adherence will be monitored through prospective accrual of administrative data and review of the medical record. Results will be reported as the proportion receiving the preventive measure versus time, i.e. with Kaplan-Meier plots. We will then determine the variance of Delay Interval. For the preliminary measure of efficacy, the Delay Interval will be compared between patients whose providers were assigned to the intervention and patients whose providers did not receive the intervention.|6 MONTHS|21 patients cared for by 6 providers in intervention arm; 17 patients cared for by 6 providers in usual care arm.|||Days||95% Confidence Interval|Mean
1354135|NCT01743729|Primary|Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84|Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.|Baseline to Day 84|ITT population with last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1354136|NCT01743729|Primary|Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Baseline to Day 84|Intent-to-treat (ITT) set included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1354137|NCT01743521|Secondary|Gene IL28B Polymorphism|To examine treatment outcome by IL28B polymorphism|Baseline|IL28B polymorphisms have not yet been performed. These are planned to be performed at a later date.||||||
1354138|NCT01743521|Secondary|CD4 and HIV RNA|In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|This data will not be analysed.||||||
1354139|NCT01743521|Secondary|Plasma Ribavirin Levels|To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Ribavirin concentration have not yet been performed. These are planned to be performed at a later date.||||||
1354140|NCT01743521|Secondary|Baseline Resistance-associated Variants|To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Baseline resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.||||||
1354141|NCT01743521|Secondary|Resistance-associated Variants|To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.||||||
1354142|NCT01743521|Secondary|Change in Hemoglobin at End of Treatment|To evaluate indicators of toxicity during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||g/L||Inter-Quartile Range|Median
1354143|NCT01743521|Secondary|Decrease in Platelets <50||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||participants|||Number
1354144|NCT01743521|Secondary|Decrease in Absolute Neutrophil Count (ANC) ≤0.75||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||participants|||Number
1354145|NCT01743521|Secondary|Undetectable HCV RNA (Week 4)|To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.|Week 4 of therapy|Missing data carried forward if previously <LLoQ|||percentage of participants|||Number
1354146|NCT01743521|Secondary|Undetectable HCV RNA (Week 3)|To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.|Week 3 of therapy|Missing data carried forward if previously <LLoQ (lower limit of quantification)|||percentage of participants|||Number
1354147|NCT01743521|Secondary|Undectectable HCV RNA (Week 2)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 2 of therapy||||percentage of participants|||Number
1354148|NCT01743521|Secondary|Undetectable HCV RNA (Week 1)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 1 of therapy||||percentage of participants|||Number
1354149|NCT01743521|Secondary|Undetectable HCV RNA (ETR)|To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)|Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||percentage of participants|||Number
1354150|NCT01743521|Secondary|SVR24|To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)|24 weeks post-treatment||||percentage of participants|||Number
1354151|NCT01743521|Primary|SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)|Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)|12 weeks post-treatment||||percentage of participants|||Number
1354152|NCT01743469|Secondary|Further Cancer-related Treatment During Follow-up Period (All Cohorts).|"Further systemic treatment was coded using World Health Organization (WHO) Drug Dictionary (versions: June 2014 for the hepatocellular carcinoma cohort and June 2013 for the ovarian, renal cell and gastric carcinoma cohorts).~A frequency table of the number and percentage of patients was provided by Anatomical Therapeutic Chemical (ATC) decode and preferred name."|16 weeks, Last Patient First Treatment + 16 weeks.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Participants|||Count of Participants
1354153|NCT01743469|Secondary|Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).|"OS is the time (in weeks) from the first study medication date to death due to any cause. Patients were censored at the date of last contact (the latest between the time of EoST/WD assessment and follow-up visits).~OS was estimated using Kaplan-Meier analysis."|Time from first study treatment to death, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
1354154|NCT01743469|Secondary|TTP by RECIST v1.1 (All Cohorts).|TTP was defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally and locally assessed RECIST v1.1 criteria (i.e. increase in tumor size ≥20%) or death due to disease progression before initiation of a new systemic treatment.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
1354155|NCT01743469|Secondary|Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).|TTP defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to disease progression before initiation of a new systemic treatment.|Every 8 weeks until disease progression, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
1354156|NCT01743469|Secondary|PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).|PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally and locally assessed RECIST v1.1 (i.e. increase in tumor size ≥20%) or death due to any cause before initiation of new systemic treatment.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
1354157|NCT01743469|Secondary|PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).|PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to any cause before initiation of new systemic treatment.|Every 8 weeks until disease progression, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
1354158|NCT01743469|Secondary|Clinical Benefit (All Cohorts).|Clinical benefit was defined as CR, PR or SD lasting at least 12 weeks using centrally or locally assessed RECIST v1.1.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
1354159|NCT01743469|Secondary|Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).|Per Choi Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=10% decrease in the sum of the longest diameter of target lesions; Progression, as a 10% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Every 8 weeks until disease progression, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
1354160|NCT01743469|Secondary|Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).|Best overall response was derived as the best overall response documented before the prespecified timepoint (gastric carcinoma cohort: 12 weeks; Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at lease one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
1354161|NCT01743469|Secondary|PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).|"PFS rate was defined as the percentage of patients who had neither progressed nor died. Tumour progression was assessed centrally using the Choi criteria.~Response was measured using the following criteria:~CR: Disappearance of all lesions, no new lesions; PR: A decrease in size ≥10% or a decrease in tumour attenuation (Hounsfield unit [HU]) ≥15% on CT, no new lesions, no obvious progression of non-measurable disease; SD: Does not meet criteria for CR, PR, or progressive disease (PD), no symptomatic deterioration attributed to tumour progression; PD: An increase in tumour size ≥10% and does not meet criteria of PR by tumour attenuation on CT, new lesions."|Week 16.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
1354170|NCT01743027|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
1354171|NCT01743027|Primary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 1 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
1354309|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|12-month follow up||||units on a scale||Standard Error|Mean
1354162|NCT01743469|Primary|Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).|"Progression (prog.) defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in sum of longest diameter of target lesions,or a measurable increase in a nontarget lesion,or appearance of new lesions.~'Progressed or Died' when time between start of study drug &first date of the following events was ≤ to analysis timepoint +3 days:1) Disease prog. according to central review using RECIST v1.1:date of disease prog. or if missing,first exam date of the visit showing a disease prog.2) Death due to any cause.~'Neither progressed, nor died' if central assessment by RECIST v1.1 confirmed no disease prog. was observed at the considered timepoint,i.e. time between start of study medication &last examination/visit date of complete response (CR),partial response (PR) or stable disease (SD) ≥ analysis timepoint 7days.In other cases, such as patient withdrawal due to AEs without tumor assessment proving prog.,the patient was considered as 'not assessable'."|Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).|ITT population: All treated patients i.e. all patients who had received at least one dose of tasquinimod. An additional patient was included in the hepatocellular carcinoma cohort, since the 52nd (last patient planned in the protocol) and 53rd were screened at the same time. This 53rd was not included in the primary analysis.|||percentage of participants||95% Confidence Interval|Number
1354163|NCT01743092|Secondary|DASS Depression|"The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. & Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation).~The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+"|12 weeks|The number of data points in this analysis equals the number who completed the study.|||units on a scale||Standard Deviation|Mean
1354164|NCT01743092|Primary|Perceived Stress Scale|"The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one’s life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress.~The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels."|12 weeks|The number of data points in this analysis equals the number who completed the study, minus 2. There were 2 missing data points in this analysis because two people did not complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1354165|NCT01743027|Secondary|Proportion of Itch Responders at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 1|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis.|||percentage of participants|||Number
1354166|NCT01743027|Secondary|Proportion of Ocular Itching Responders at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 14|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis.|||percentage of participants|||Number
1354167|NCT01743027|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
1354168|NCT01743027|Secondary|Mean Total Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
1354169|NCT01743027|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
1354172|NCT01743027|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 14 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
1354173|NCT01743001|Secondary|Change From Baseline to Week 16 in Quality of Life (QoL), Assessed by the Short Form-36 (SF-36) Questionnaire|"The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of the functional health and well-being scores (i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health), as well as psychometrically based physical and mental health summary measures and a preference-based health utility (health rated as much better now than one year ago to much worse now than one year ago). It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group.~For each of the domains and scores that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning). A higher score for the individual domains and summary component scores indicates a better condition of the subject."|From baseline to Week 16|Full analysis set (excluding children <14 years of age and Down Syndrome subjects)|||Score on a scale||Standard Deviation|Mean
1354174|NCT01743001|Secondary|Change From Baseline to Week 16 in Dyspnea, Assessed by the Borg Dyspnea Index|This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 16 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 (‘Nothing at all’) to 10 (‘Very, very severe – maximal’). A decrease in the Borg dyspnea index indicates an improvement.|From baseline to Week 16|Full analysis set: The analysis was performed on the full analysis set (FAS), i.e., all randomized subjects in the treatment group to which they were randomized and by imputing missing values at Week 16 according to pre-defined rules.|||Score on a scale||Standard Deviation|Mean
1354175|NCT01743001|Secondary|Change From Baseline to Week 16 in WHO Functional Class|A shift in WHO functional classes is considered an 'improvement' when shifting to a lower class (e.g. from class III to class II) or a 'worsening' when shifting to a higher class (e.g. from class III to class IV). Definition of functional classes as follows - Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g. doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most patients also have edema in the feet and ankles as result of right heart failure.|From baseline to Week 16|Full analysis set: The analysis was performed on the full analysis set (FAS), i.e., all randomized subjects in the treatment group to which they were randomized and by imputing missing values at Week 16 according to pre-defined rules.|||Participants|||Count of Participants
1354176|NCT01743001|Primary|Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD)|The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|From baseline to Week 16|Full analysis set: The analysis was performed on the full analysis set (FAS), i.e., all randomized subjects in the treatment group to which they were randomized and by imputing missing values at Week 16 according to pre-defined rules.|||meter||Standard Deviation|Mean
1354177|NCT01742936|Primary|International Normalized Ratio (INR) Performed by Hospital Laboratory|Measuring the bloods ability to clot by the hospital's reference laboratory.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)|Three cases of device error with CoaguChek®, 1 insufficient blood for measurement in the laboratory, and 1 communication failure during sending the blood sample to the laboratory occurred leaving 87 patients for analysis.|||ratio||Standard Deviation|Mean
1354178|NCT01742936|Primary|International Normalized Ratio (INR) on CoaguChek|Measuring the blood's ability to clot on a handheld monitor.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)||||ratio||Standard Deviation|Mean
1354179|NCT01742897|Primary|Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30|The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst).|Baseline, Day 30|Intent-to-treat (ITT) analysis population included all participants regardless of their compliance with the protocol.|||Millimeter (mm)||95% Confidence Interval|Median
1354180|NCT01742832|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|"The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included.~MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used."|Baseline and final MADRS scores during the double-blind phase.||||units on a scale||Standard Deviation|Mean
1354181|NCT01742364|Other Pre-specified|Fluid Leakage on Skin at Injection Site||Immediately post-vaccination|For adults, the skin fluid deposition was estimated and categorized by the vaccinator (e.g., no wetness, damp skin, flow on skin, spray in air); for infants, volume was measured objectively and categorized by the filter paper technique (units in µl).|||participants|||Number
1354182|NCT01742364|Other Pre-specified|Diameter of Skin Bleb||Immediately post-vaccination||||participants|||Number
1354310|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|6-month follow up||||units on a scale||Standard Error|Mean
1354183|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.~Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|14 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.~Immunogenicity was not measured for adults in the study."|||percentage responding to cytokines||Inter-Quartile Range|Median
1354184|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 (Cluster of Differentiation 4) T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.~Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|10 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.~Immunogenicity was not measured for adults in the study."|||percentage responding to cytokines||Inter-Quartile Range|Median
1354185|NCT01742364|Primary|Systemic Adverse Events|Systemic adverse events, solicited and unsolicited, including symptoms of lethargy, disrupted feeding patterns, fever, lymphadenopathy, rash, or any other physical abnormalities will be monitored for up to fourteen weeks following vaccination.|14 weeks||||Adverse events|||Number
1354186|NCT01742364|Primary|Injection Site Adverse Events (Following Injection)|Injection site adverse events including redness, swelling, induration, tenderness, ulceration, fluctuation , drainage, laceration, bruising, and scarring will be monitored for up to fourteen weeks following vaccination.|14 weeks||||Adverse events|||Number
1354187|NCT01742091|Secondary|Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)|N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. Least squares (LS) mean was adjusted for baseline P1NP, treatment group, time (i.e. study day), and interaction between treatment group and time.|Predose, through Day 141|All participants who received study drug and had evaluable P1NP results at the analyzed time points.|||microgram per liter (ug/L)||90% Confidence Interval|Least Squares Mean
1354188|NCT01742091|Secondary|Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies||Predose (Day 1) and Postdose (Day 29, 85 and 141)|All participants who received study drug and had evaluable antibody results at the analyzed time points.|||participants|||Number
1354189|NCT01742091|Secondary|Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85|A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²). The least squares (LS) mean was adjusted for baseline lumbar spine BMD and treatment group.|Predose and Day 85|All participants who received study drug and had evaluable BMD results at the analyzed time points.|||gram per square centimeter (g/cm^2)||90% Confidence Interval|Least Squares Mean
1354190|NCT01742091|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546|Weekly AUC (AUC[0-tau]) during the first and last dosing interval for each participant receiving LY2541546 is reported.|Day 1 through Day 141|All participants who received study drug and had sufficient evaluable results for PK analysis.|||nanomole x hour per mililiter (nmol*h/mL||Standard Deviation|Mean
1354191|NCT01742091|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|"An SAE is any AE from this study that results in one of the following outcomes:~death~initial or prolonged inpatient hospitalization~a life-threatening experience (that is, immediate risk of dying)~persistent or significant disability/incapacity~congenital anomaly/birth defect~is considered significant by the investigator for any other reason"|Day 1 through Day 141|All participants who received study drug.|||participants|||Number
1354192|NCT01741792|Secondary|CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
1354193|NCT01741792|Secondary|CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354194|NCT01741792|Secondary|CD8+ TEM Cells as a Percentage of All CD8+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
1354195|NCT01741792|Secondary|CD8+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354196|NCT01741792|Secondary|CD8+ TCM Cells as a Percentage of All CD8+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
1354197|NCT01741792|Secondary|CD8+ TCM Cell Counts|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||100 cells/µL||Standard Deviation|Mean
1354198|NCT01741792|Secondary|CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
1354199|NCT01741792|Secondary|CD8+ Naive T-Cell Count|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354200|NCT01741792|Secondary|CD4+ TEM Cells as a Percentage of All CD4+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD4+ T-cells||Standard Deviation|Mean
1354201|NCT01741792|Secondary|CD4+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354202|NCT01741792|Secondary|CD4+ TCM Cells as a Percentage of All CD4+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD4+ T-cells||Standard Deviation|Mean
1354255|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
1354203|NCT01741792|Secondary|CD4+ Central Memory T-Cell (TCM) Count|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354204|NCT01741792|Secondary|CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD4+ T-cells||Standard Deviation|Mean
1354205|NCT01741792|Secondary|CD4+ Naive T Cell Count|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354206|NCT01741792|Secondary|CD4+ T-Cell to CD8+ T-Cell Ratio|CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||ratio||Standard Deviation|Mean
1354207|NCT01741792|Secondary|CD19+ B-Cell to CD3+ T-Cell Ratio|CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||ratio||Standard Deviation|Mean
1354208|NCT01741792|Secondary|CD8+ T-Cells as a Percentage of All Lymphocytes|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
1354209|NCT01741792|Secondary|CD8+ T-Cell Count|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354210|NCT01741792|Secondary|CD4+ T-Cells as a Percentage of All Lymphocytes|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
1354211|NCT01741792|Secondary|CD4+ T-Cell Count|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354212|NCT01741792|Secondary|CD3+ T-Cells as a Percentage of All Lymphocytes|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
1354311|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|3-month follow up||||units on a scale||Standard Error|Mean
1354213|NCT01741792|Secondary|CD3+ T-Cell Count|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354214|NCT01741792|Secondary|CD19+ B-Cells as a Percentage of All Lymphocytes|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
1354215|NCT01741792|Secondary|CD19+ B-Cell Count|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354216|NCT01741792|Secondary|Granulocyte Count||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354217|NCT01741792|Secondary|Monocyte Counts||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354218|NCT01741792|Secondary|Lymphocyte Counts|Lymphocyte counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354219|NCT01741792|Secondary|Leukocyte Counts|Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
1354220|NCT01741792|Secondary|Blinatumomab Steady State Serum Concentration|Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.|Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)|Pharmacokinetic (PK) data set (all participants who received any infusion of blinatumomab and had at least one PK sample collected).|||pg/mL||Standard Deviation|Mean
1354221|NCT01741792|Secondary|Number of Participants With Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.~An adverse event or suspected adverse drug reaction was considered serious if it resulted in one of the following outcomes:~Resulted in death;~Was life-threatening;~Required inpatient hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions;~Was a congenital anomaly or birth defect;~Was a medically important condition.~The Investigator used medical judgment to determine whether there was a causal relationship (ie, related [reasonably possible] or unrelated [not reasonably possible]) between an adverse event and blinatumomab."|From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.|Safety analysis set|||participants|||Number
1354222|NCT01741792|Secondary|Overall Survival (OS)|The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.|From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.|Efficacy set|||months||95% Confidence Interval|Median
1354256|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
1354223|NCT01741792|Secondary|Progression-free Survival (PFS)|The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.|From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.|Efficacy set|||months||95% Confidence Interval|Median
1354224|NCT01741792|Secondary|Duration of Partial Response|The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of PR during the first treatment cycle|||months||95% Confidence Interval|Median
1354225|NCT01741792|Secondary|Duration of Complete Response|The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of CR during the first treatment cycle|||months||95% Confidence Interval|Median
1354226|NCT01741792|Secondary|Duration of Objective Response|The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with an overall objective response of CR or PR during the first treatment cycle|||months||95% Confidence Interval|Median
1354227|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Partial Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (<50% decrease in size of masses) of measureable disease and no new sites.|During the first 8 weeks|Efficacy set|||percentage of participants||95% Confidence Interval|Number
1354228|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Complete Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.|During the first 8 weeks|Efficacy set|||percentage of participants||95% Confidence Interval|Number
1354229|NCT01741792|Primary|Overall Objective Response Rate During Treatment Cycle 1|"Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR).~Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites."|During the first 8 weeks|Efficacy Set includes all participants who completed at least 7 days of infusion on the highest intended dose level.|||percentage of participants||95% Confidence Interval|Number
1354230|NCT01741701|Secondary|NonMotor Symptom Questionnaire (NMSQuest)|"The NMSQuest is a 30 item questionnaire with 30 yes/no questions. There is a total of 30 points with each yes score representing 1 point and therefore the higher the score the greater number of nonmotor symptoms present. The score can range from 0 to 30."|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1354231|NCT01741701|Secondary|Geriatric Depression Scale (GDS)|The GDS is a measure of depression. The scale has 30 yes/no questions. Each question has a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score the greater the depression.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1354232|NCT01741701|Secondary|Montreal Cognitive Assessment (MoCA)|The MoCA is an assessment of cognitive function. The total possible score ranges from 0 to 30 points with a lower score representing greater cognitive impairment.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1354233|NCT01741701|Secondary|Parkinson's Disease Questionnaire - 39 (PDQ-39)|The PDQ-39 is a measure of quality of life in Parkinson's disease patients. It has 39 questions each with a response from 0-4 for a total of 156 points. The total score is calculated as a percentage so the scores of the 39 items are added and divided by 156 and multiplied by 100. The higher the score the worse quality of life.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||percentage of total possible score||Standard Deviation|Mean
1354446|NCT01739361|Primary|F2-isoprostanes After 72 Hours of Acetaminophen or Placebo|F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.|72 hours after randomization||||pg/mL||Inter-Quartile Range|Median
1354234|NCT01741701|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). This measure examined the ADL + Motor subscales which have a total of 160 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1354235|NCT01741701|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). The total scores represents the sum of each of these sections for a total of 176 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1354236|NCT01741688|Secondary|Disease Activity Score Based on 28 Joints (DAS28)|"The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad.~The Score is developed under the follow formula:~DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score.~This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission."|At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks||||DAS28 score||Full Range|Median
1354237|NCT01741688|Secondary|Total Swollen Joint Count (SJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks||||Number of swollen joints/participant||Full Range|Median
1354238|NCT01741688|Secondary|Total Tender Joint Count (TJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks||||Number of tender joints/participant||Full Range|Median
1354239|NCT01741688|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||At baseline||||percentage of participants|||Number
1354240|NCT01741688|Secondary|Non-adherence Rate of Physician to the Recommended Dosing Regimen||Approximately 16 months|||||||
1354241|NCT01741688|Secondary|Time to Restoration of Initial Dosing Regimen||Approximately 16 months|||||||
1354242|NCT01741688|Secondary|Number of Participants Discontinued From Tocilizumab for Other Reasons|This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.|Approximately 16 months||||participants|||Number
1354243|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy|Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.|Approximately 16 months||||percentage of participants|||Number
1354244|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety|Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.|Approximately 16 months||||percentage of participants|||Number
1354245|NCT01741688|Secondary|Median Duration of Treatment||Approximately 16 months||||months||Full Range|Median
1354246|NCT01741688|Secondary|Number of Participants With Dose Modifications at 6 Months||At 6 months||||participants|||Number
1354247|NCT01741688|Secondary|Median Dose at 6 Months||At 6 months|Number of participants remaining in the study at 6 months|||mg/kg of body weight||Full Range|Median
1354248|NCT01741688|Secondary|Number of Participants Starting Tocilizumab After Failing Other Biologic Agents|Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.|At baseline||||participants|||Number
1354249|NCT01741688|Secondary|Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment includes participants, who were treated with DMARDs 6 months before being included in the study. DMARDs treatment at baseline includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab."|At baseline||||percentage of participants|||Number
1354250|NCT01741688|Secondary|Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis|Systemic manifestation measured by C-reactive protein levels > 3|At baseline||||percentage of participants|||Number
1354251|NCT01741688|Primary|Number of Participants on Tocilizumab at 6 Months After Treatment Initiation||At 6 months||||participants|||Number
1354252|NCT01741480|Secondary|Mortality|Death during hospitalization will be used to determine the presence of this outcome.|Patients will be asessed for the secondary outcome measure during an average of 28 days..||2018-06-30|06/2018||||
1354253|NCT01741480|Primary|ICU Transfer|Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.|Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.||||participants|||Number
1354254|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
1354257|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354258|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
1354259|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
1354260|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
1354261|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
1354262|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354263|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
1354264|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
1354265|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
1354266|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
1354267|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354268|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
1354269|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|12-month follow up||||units on a scale||Standard Error|Mean
1354270|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|6-month follow up||||units on a scale||Standard Error|Mean
1354271|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|3-month follow up||||units on a scale||Standard Error|Mean
1354272|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354273|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Baseline||||units on a scale||Standard Error|Mean
1354274|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|12-month follow up||||units on a scale||Standard Error|Mean
1354275|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|6-month follow up||||units on a scale||Standard Error|Mean
1354276|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|3-month follow up||||units on a scale||Standard Error|Mean
1354277|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354278|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Baseline||||units on a scale||Standard Error|Mean
1354279|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|12-month follow up||||percentage of correct steps||Standard Error|Mean
1354280|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|6-month follow up||||percentage of correct steps||Standard Error|Mean
1354281|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|3-month follow up||||percentage of correct steps||Standard Error|Mean
1354282|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Immediately Post-Intervention, at 4 weeks||||percentage of correct steps||Standard Error|Mean
1354283|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Baseline||||percentage of correct steps||Standard Error|Mean
1354284|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|12-month follow up||||percentage of correct steps||Standard Error|Mean
1354285|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|6-month follow up||||percentage of correct steps||Standard Error|Mean
1354286|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|3-month follow up||||percentage of correct steps||Standard Error|Mean
1354287|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Immediately Post-Intervention, at 4 weeks||||percentage of correct steps||Standard Error|Mean
1354288|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Baseline||||percentage of correct steps||Standard Error|Mean
1354289|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
1354290|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
1354291|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
1354312|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0–4, with higher scores indicating safer drug use.|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354292|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354293|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
1354294|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
1354295|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
1354296|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
1354297|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354298|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
1354299|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
1354300|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
1354301|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
1354302|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354303|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
1354304|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles)."|12-month follow up||||units on a scale||Standard Error|Mean
1354305|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|6-month follow up||||units on a scale||Standard Error|Mean
1354306|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|3-month follow up||||units on a scale||Standard Error|Mean
1354307|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
1354314|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|12-month follow up||||Percentage of correct steps||Standard Error|Mean
1354315|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|6-month follow up||||Percentage of correct steps||Standard Error|Mean
1354316|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|3-month follow up||||Percentage of correct steps||Standard Error|Mean
1354317|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Immediately Post-Intervention, at 4 weeks||||Percentage of correct steps||Standard Error|Mean
1354318|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Baseline||||Percentage of correct steps||Standard Error|Mean
1354319|NCT01741272|Secondary|Complications|Incidence of any surgical or medical complications will be prospectively documented.|2 & 6 weeks, 3, 6, 12, 24 months|37 subjects (17 Early Mobilization, 20 Standard Rehabilitation) had non-re-tear complications. 5 subjects reported more than one complication.|||participants|||Number
1354320|NCT01741272|Secondary|Abduction Strength Using the Power Component of the Constant Score|The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.|Baseline, 24 months||||units on a scale||Inter-Quartile Range|Mean
1354321|NCT01741272|Secondary|WORC Questionnaire|Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.|Baseline, 6, 12, 24 months||||units on a scale||Inter-Quartile Range|Mean
1354322|NCT01741272|Secondary|Pain Questionnaire|Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.|Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months||||centimeters||Standard Deviation|Mean
1354323|NCT01741272|Primary|Change in Range of Motion (ROM)From Baseline to 24 Months|"Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level).~Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction."|Baseline, 6 weeks, 3, 6, 12, 24 months||||degrees||Standard Deviation|Mean
1354324|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #9|On a 0-10 scale, how satisfied are you with the results of your pain treatment with 0 being extremely dissatisfied and 10 being extremely satisfied. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354325|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #8|On a 0-10 scale, were you allowed to participate in decisions about your pain treatment as much as you wanted to with 0 being not at all and 10 being entirely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354326|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #7|Select the percentage (from 0%-100%) of pain relief you received from all medical and non-medical treatments in the first 24 hours. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||percentage of pain relieved||Standard Error|Mean
1354327|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6d|On a 0-10 scale, how severe was your dizziness where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354328|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6c|On a 0-10 scale, how severe was your itching where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354329|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6b|On a 0-10 scale, how severe was your drowsiness where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354330|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6a|On a scale of 0-10, what was the severity of your nausea where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354331|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5d|How much, on a scale of 0-10, did the pain cause you to feel helpless where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354332|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5c|How much, on a scale of 0-10, did the pain cause you to feel frightened where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354333|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5b|On a scale of 0-10, how much did pain cause you to feel depressed where 0 is not al all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354334|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5a|On a scale of 0-10, how much did the pain cause you to feel anxious where 0 is not at all anxious and 10 is extremely anxious. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354335|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4d|How much, on a scale of 0-10, did pain interfere with staying asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354336|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4c|How much, on a 0-10 scale, did pain interfere with falling asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354337|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4b|How much, on a 0-10 scale, did pain interfere with doing activities out of bed (walking, sitting in chair, standing at sink) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354338|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4a|How much, on 0-10 scale, did pain interfere with doing activities in bed (turning, sitting up, repositioning) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354339|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #3|How often were you in severe pain in the first 24 hours (percentage 0-100%). 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||percentage of time||Standard Error|Mean
1354340|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #2|On 0-10 scale, indicate the worst pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354341|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #1|Please indicate on 0-10 scale the least pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
1354342|NCT01741259|Secondary|Total Drug Dose|Pharmacy will generate a report of the drug total from the pump on return to pharmacy.|48 hours post-op or when the epidural is stopped||||milligrams of drug per hour||Standard Deviation|Mean
1354343|NCT01741259|Secondary|Adverse Outcomes|Adverse outcomes such as seizures or respiratory depression will be reported to anesthesia personnel by nursing if they occur. Patients are monitored for respiratory rate and sedation every 1 hour for 24 hours, then every 2 hours for 24 hours. Pulse, blood pressure, and neurocirculatory checks are performed every 2 hours for 24 hours and then every 4 hours per our nursing protocol.|36-48 hours post-op (until the epidural is stopped)||||participants|||Number
1354344|NCT01741259|Secondary|Inadequate Analgesia|Patients routinely get scheduled ibuprofen as an adjunct to the epidural infusion. The record will be reviewed to see if ketorolac is substituted for ibuprofen or other pain medications such as acetaminophen either alone or in combination with oxycodone or other narcotic pain relievers are administered. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if inadequate analgesia was the cause.|36-48 hours post-op (until the epidural is stopped)||||participants|||Number
1354345|NCT01741259|Secondary|Dysphoria|The incidence of dysphoria will be captured when a nurse calls the anesthesia team to alert them. This information is tracked on the physician rounding sheet. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if dysphoria was the cause.|36-48 hours post-op (until epidural is stopped)||||participants|||Number
1354346|NCT01741259|Secondary|Pruritus|The incidence of pruritus will be estimated by the administration of diphenhydramine or nalbuphine during the study period as recorded in the patient record.|36-48 hours post-op (until the epidural is stopped)||||participants|||Number
1354347|NCT01741259|Secondary|Nausea and Vomiting|The incidence of nausea and vomiting will be estimated by the administration of ondansetron during the study period as recorded in the patient record.|36-48 hours post-op (until epidural is stopped)||||participants|||Number
1354348|NCT01741259|Primary|Verbal Pain Score With Movement|Verbal Pain Score on a 0-10 scale is recorded by the nurse at 0, 4, 8, 12, 16, 20, 24, 28, 32, 36,40, 44, and 48 hours after transfer to the post-partum floor. On this scale, 0 represents no pain at all and 10 represents the worst pain imaginable. Because we were relying on nurses to capture this data in the course of normal patient care, scores within 1 hour before or after the goal time were accepted. For each patient, the average of all pain scores was taken and this was considered to be the average pain score while the epidural meperidine was being given.|36-48 hours post-op (until epidural is stopped)||||units on a scale||Standard Deviation|Mean
1354349|NCT01740817|Secondary|Extracellular Signal-regulated Kinase (ERK) Phosphorylation in Muscle|Forty eight hrs after lipid or saline infusion, muscle ERK phosphorylation will be measured by western blot. The results are compared to determine whether lipid infusion increases muscle ERK phosphorylation compared to saline infusion. Saline mean was used to normalize the data for both arms.|48 hr following lipid or saline infusion, pre-clamp||||densitometry value||Standard Error|Mean
1354350|NCT01740817|Secondary|TLR4 Messenger Ribonucleic Acid (mRNA) in Muscle|"Forty eight hrs after lipid or saline infusion, muscle TLR4 mRNA levels will be measured by RT-PCR. The results are compared to determine whether lipid infusion increases muscle TLR4 mRNA expression compared to saline infusion.~Saline mean was used to normalize the data for both arms."|48 hr following lipid/saline infusion, pre-clamp||||ng TLR4 mRNA/ng Actin mRNA||Standard Error|Mean
1354351|NCT01740817|Primary|Muscle Insulin Sensitivity-M Value|"Forty eight hrs after lipid or saline infusion, muscle insulin sensitivity will be measured by insulin clamp. The results are compared to determine whether lipid infusion reduces muscle insulin sensitivity compared to saline infusion..~The M value is defined as the exogenous glucose infusion rate at steady state (i.e, when the exogenous glucose infusion rate is equal to the rate of whole body glucose disposal)."|48 hr after lipid/saline infusion||||mg/kg.min||Standard Error|Mean
1354352|NCT01740726|Other Pre-specified|Child's Behavior Checklist - Parent Version (CBCL-P)|Completed by parents to describe the child’s behavioral and emotional difficulties. Scores reflect observed problems and level of adaptive functioning.|18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
1354353|NCT01740726|Other Pre-specified|Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)|Semi-structured interview that assesses psychiatric symptoms, treatments, and functional outcomes in the time period that has elapsed since the previous assessment and tracks change over time.|18 wks., 30 wks, 42 wks|Data are not available for analysis.||||||
1354354|NCT01740726|Secondary|Change in Hope Based on Children's Hope Scale (CHS)|Assesses self-perception of ability to set and work toward goals.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
1354355|NCT01740726|Secondary|Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)|Assesses seriousness of suicidal intent.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
1354356|NCT01740726|Secondary|Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)|Measures anxiety symptom severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
1354357|NCT01740726|Secondary|Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)|Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
1354358|NCT01740726|Secondary|Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)|Clinician's rating of symptom severity and improvement since baseline.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
1354359|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)|Interview-based measure, completed with both the parent and child, that assesses depression severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
1354360|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)|Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.|Baseline, 42 weeks||||units on a scale|||Number
1354361|NCT01740713|Secondary|Adverse Events|All the medical occurrences that started after the administration of the drug|from drug administration up to 8 days post treatment||||participants|||Number
1354362|NCT01740713|Primary|Cmin|Minimum plasma concentration. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||microM||Inter-Quartile Range|Median
1354363|NCT01740713|Primary|Css|Plasma concentration reached at steady state. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||microM||Inter-Quartile Range|Median
1354364|NCT01740713|Primary|Cmax|Maximum concentration reached in plasma. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||microM||Inter-Quartile Range|Median
1354365|NCT01740713|Primary|Ka|Absorption rate constant. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||h^-1||Standard Error|Mean
1354366|NCT01740713|Primary|Tmax|Time at which the maximum concentration (Cmax) is reached. Secondary pharmacokinetic parameters such as Cmax, Min, Tmax, Css and AUC (0-8h) were derived based on the individual predicted concentration vs. time profiles.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||hour||Inter-Quartile Range|Median
1354367|NCT01740713|Primary|V/F|volume of distribution after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||litres||Standard Error|Mean
1354368|NCT01740713|Primary|AUC (0-8h)|Area under concentration versus time curve from 0 to 8 h post dosing. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||micromol*h/L||Inter-Quartile Range|Median
1354369|NCT01740713|Primary|CL/F|Plasma clearance after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||litre/h||Standard Error|Mean
1354370|NCT01740440|Secondary|To Evaluate the Subject’s Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).|The Subject Satisfaction Assessment Scale is a 5 point scale where a subject rates their satisfaction level as Very Satisfied, Satisfied, No Opinion, Unsatisfied or Very Unsatisfied.|6 weeks, 12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations|||percentage of subjects|||Number
1354371|NCT01740440|Secondary|To Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Including the Global Aesthetic Improvement Scale (GAIS) at 6 Weeks Compared to Baseline|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).~The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.~For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|6 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations|||units on a scale||Full Range|Mean
1354372|NCT01740440|Primary|Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).~The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.~For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations.|||Scores on a Scale||Full Range|Mean
1354386|NCT01740414|Secondary|Positive Subjective Effects to Oxycodone|"Participants are shown a 100-mm line and asked to indicate on that line the extent to which they agree with the descriptor of the drug effect such as Liking/Liked the Drug. On this visual analog scale participants were instructed that the Left/ 0 mm point on the line represents not at all, while the right/100 mm point represents “Extremely.”"|42 days||||units on a scale||Standard Deviation|Mean
1354373|NCT01740427|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)|An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.|From the participant randomization up to 28 days after last dose of study drug, up to 2.5 years|AT population = ITT population because all the participants randomized were treated with study drugs per study design.|||Percentage of Participants|||Number
1354374|NCT01740427|Secondary|Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)|FACT is a modular approach to assess participant health-related quality of life using a ‘core’ set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.|From Baseline up to 2.5 years|Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
1354375|NCT01740427|Secondary|Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index|The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).|From Baseline up to 2.5 years|Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
1354376|NCT01740427|Secondary|Observed Plasma Trough Concentration (Ctrough) at Steady-State|Summary of Plasma Palbociclib Within-Patient Mean Steady-State Trough Concentrations.|0 hour (predose) on Day 14 of cycles 1 and 2|Pharmacokinetic analysis set was a subset of AT participants, who were treated with Palbociclib and had at least one measured plasma concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1354377|NCT01740427|Secondary|Corrected QT Interval (QTc)|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.|For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10. ECGs beyond Cycle 10 were performed as clinically indicated|The AT population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
1354378|NCT01740427|Secondary|Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.|Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14|QTc analysis set is a subset of as treated (AT) population who were in Group 1; their QTc was used to study the effect of palbociclib on QT interval via serial triplicate ECGs with PK draws; and who had ≥ 1 pair of time-matched Day 0 and palbociclib postdose (Cycle1 Day14) measurements.|||msec||90% Confidence Interval|Least Squares Mean
1354379|NCT01740427|Secondary|Tumor Tissue Biomarkers, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6): Protein Biomarker Analyses by Using Immunohistochemistry Are Presented|"PFS survival by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~Positive is defined as H-Score ≥1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300.~ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product."|From randomization until end of treatment (up to approximately 24 Months)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1354404|NCT01740297|Secondary|Phase 2: Kaplan-Meier Estimate of Percentage of Participants Alive at Month 12 and 24|The overall survival estimates at month 24 data were not mature as most participants had not been followed for 24 months at the time of data cutoff.|Months 12 and 24; The median (Q1, Q3) follow-up time from randomization to the data cutoff date for the analysis was 80.6 (58.3, 106.3) weeks.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
1354380|NCT01740427|Secondary|Disease Control (DC)/Clinical Benefit Response (CBR)|DC is defined as the overall CR, PR, or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Disease Control Rate (DCR) is defined as the patients with CR, PR, or SD ≥24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD≥24 weeks, or who died, progressed,or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD≥24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression|From randomization until end of treatment (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1354381|NCT01740427|Secondary|Duration of Response (DR)|DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as [the date response ended (i.e. date of PD or death) – first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of patients with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|Patients who had tumor response with CR or PR during study. A total of 206 and 85 patients had objective response in the palbociclib plus letrozole and placebo plus letrozole arms, respectively.|||Months||95% Confidence Interval|Median
1354382|NCT01740427|Secondary|Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator|The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|Patients who had measurable disease at baseline. A total of 338 and 171 patients had measurable disease at baseline in the palbociclib plus letrozole and placebo plus letrozole arms, respectively.|||Percentage of participants||95% Confidence Interval|Number
1354383|NCT01740427|Secondary|Objective Response as Assessed by the Investigator|Objective Response (OR) is defined as the overall complete response (CR) or partial response (PR) according to the RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1354384|NCT01740427|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator.|PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date − randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.|From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1354385|NCT01740414|Other Pre-specified|Pain Intensity|15-item shortened form of the McGill Pain Questionnaire (Melzack, 1987) that is used to assess the sensory and affective dimensions of the pain experienced Participants describe their experience of pain by choosing among a series of possible answers (None [score=1], Mild [score=2], Moderate [score=3], or Severe [score=4]). They were asked to describe the pain as “Throbbing,” “Shooting,” “Stabbing,” “Sharp,” “Cramping,” “Gnawing,” “Hot-Burning,” “Aching,” “Heavy,” “Tender,” “Splitting,” “Tired-Exhausting,” “Sickening,” “Fearful,” and “Punishing-Cruel.” Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60.|42 days||||units on a scale||Standard Error|Mean
1354387|NCT01740414|Primary|Drug Self-administration Breakpoint|Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.|42 days||||Clicks on a computer mouse||Standard Error|Mean
1354388|NCT01740401|Secondary|T Regulatory Cell Profile in Peripheral Blood|Peripheral blood taken at baseline/various therapeutic time points/possibly maintenance cycles to evaluate T regulatory cells identified, serially monitored by polychromatic flow cytometry using FoxP3+/CD4+/CD127low/CD25hi markers.|Week 60|Primary Endpoint not met, study terminated, data not collected||||||
1354389|NCT01740401|Other Pre-specified|Tumor-specific T Cell Responses Will be Measured in a Subset of Patients Who Have Biopsy Accessible Tumor and Have Tumor Biopsies Taken.|One of the tumor punch biopsy will be put in formalin for paraffin-embedding. The other tumor punch biopsy will be processed to obtain lysates to be used as antigens for the T cell assays. Two tumor punch biopsies (4mm in diameter) will be obtained before and after therapy (baseline and week 12, and optional during weeks 24, 36, and 48) if patients have accessible tumors.|Week 48|Primary Endpoint not met, study terminated, data not collected||||||
1354390|NCT01740401|Secondary|Progression-free Survival|Progression-free survival is measured from date of entry to date of 1st documented evidence of recurrence, confirmation of PD, or death (whichever is 1st). T regulatory cells are measured on D1 (pre CTX) & D3 of each cycle.|Week 60|Primary Endpoint not met, study terminated, data not collected||||||
1354391|NCT01740401|Primary|The Anti-tumor Activity of the Combination of Low Dose Cyclophosphamide and CTLA-4 Blockade Using Objective Response Rate (ORR)|Objective response rate (ORR) using mWHO RC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|12 weeks||||Participants|||Count of Participants
1354392|NCT01740388|Other Pre-specified|Bulbar Conjunctival Injection|Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)||||participants|||Number
1354393|NCT01740388|Other Pre-specified|Ocular Conjunctival Discharge|Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)|Analysis population is only Subjects with non-missing data, Ocular Discharge Evaluated on the Baseline-Designated Study Eye|||participants|||Number
1354394|NCT01740388|Secondary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)||||participants|||Number
1354395|NCT01740388|Secondary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])|||participants|||Number
1354396|NCT01740388|Primary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF [Last Observation Carried Forward])|||participants|||Number
1354397|NCT01740388|Primary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])|||participants|||Number
1354398|NCT01740362|Primary|Renal Clearance (CL R)|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.|0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose|Analysis set included all participants who received study medication.|||mL/min||Standard Deviation|Mean
1354399|NCT01740362|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||hours||Standard Deviation|Mean
1354400|NCT01740362|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||hours||Full Range|Median
1354401|NCT01740362|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||ng/mL||Standard Deviation|Mean
1354402|NCT01740362|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1354403|NCT01740297|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening or disabling AE and grade 5 = death related to AE.~The investigator assessed whether each AE was possibly related to talimogene laherparepvec (T-VEC) and/or ipilimumab (Imab).~Note that one participant in the Phase 2 Ipilimumab Alone group was incorrectly noted as having an AE leading to discontinuation of T-VEC which was discovered and corrected after this analysis was conducted."|From first dose of study treatment until 30 days after the last dose; median duration of treatment was 14.7, 9.1, and 21.1 weeks in each treatment group respectively.|All participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).|||participants|||Number
1354493|NCT01738737|Secondary|Change From Baseline in Timed Get Up and Go Test|Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||seconds||Inter-Quartile Range|Median
1354405|NCT01740297|Secondary|Phase 2: Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Participants without an event were censored at the last date they were known to be alive. Participants with a vital status obtained after the data cut-off were censored at the date cut-off date.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||months||95% Confidence Interval|Median
1354406|NCT01740297|Secondary|Phase 2: Resection Rate|Resection rate was defined as the percentage of participants who had surgical procedures for melanoma that resulted in a partial reduction or complete eradication of all previously unresectable cutaneous or visceral metastatic disease. Surgical procedures for melanoma with palliative intent (eg, for pain control) in the presence of disease progression were not considered resection.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
1354407|NCT01740297|Secondary|Phase 2: Progression-free Survival|Progression-free survival was measured from the date of randomization to the date of disease progression (as measured by modified irRC) or death on or before the data cutoff date, whichever occurred first. Participants who had no disease progression and did not die while on study were censored at the last disease assessment date.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||months||95% Confidence Interval|Median
1354408|NCT01740297|Secondary|Phase 2: Duration of Response|Duration of response was calculated only for participants with an objective response per modified irRC and was defined as the time from first confirmed objective response (CR or PR) to confirmed disease progression per the modified irRC or death, whichever was earlier. Responders who did not have an event of death or disease progression were censored at their last evaluable tumor assessment date.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|Participants randomized in phase 2 with a confirmed CR or PR.|||months||95% Confidence Interval|Median
1354409|NCT01740297|Secondary|Phase 2: Time to Response|Time to confirmed response (TTR) was defined as the time from randomization to the date of the first confirmed CR or PR per modified irRC criteria. Participants who did not have a confirmed CR or PR were censored at their last evaluable tumor assessment date.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||months||95% Confidence Interval|Median
1354410|NCT01740297|Secondary|Phase 2: Durable Response Rate|Durable response rate (DRR) was defined as the percentage of participants with a duration of response (best response of CR or PR) per modified irRC of at least 6 months. Duration of response is the time from the first confirmed CR or PR to confirmed disease progression per the modified irRC or death, whichever occurs earlier.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
1354411|NCT01740297|Secondary|Phase 2: Disease Control Rate|"Disease control rate (DCR) was defined as the percentage of participants with a best overall response of CR, PR or SD based on investigator assessment according to the modified irRC.~CR: Complete disappearance of all lesions and no new lesions; any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. SD: Not meeting criteria for CR or PR, in absence of PD and no earlier than 77 days after the date of enrollment/randomization.~CR and PR must have been confirmed at 2 consecutive assessments ≥ 4 weeks apart."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
1354412|NCT01740297|Secondary|Phase 2: Best Overall Response|"Best overall response was categorized in descending order as a complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or unevaluable (UE) based on investigator assessment according to the modified irRC.~CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. PD: Increase in tumor burden ≥ 25% relative to nadir. SD: Not meeting criteria for CR or PR, in absence of PD and no earlier than 77 days after the date of enrollment/randomization.~CR, PR and PD must have been confirmed at 2 consecutive assessment ≥ 4 weeks apart.~Assessments occurring after the start of the first subsequent anticancer therapy or removal of a lesion were not included."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||participants|||Number
1354413|NCT01740297|Secondary|Phase 1b: Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) according to the modified immune-related response criteria (irRC) assessed by the investigator. Tumors were examined clinically and by computed tomography (CT) or magnetic resonance imaging (MRI).~CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. Response must have been confirmed by a repeat, consecutive assessment ≥ 4 weeks from the date first documented. Participants who did not have any follow-up tumor assessments were regarded as non-responders."|Tumor response was assesed every 12 weeks until disease progression; median follow-up time was 148.4 weeks.|All phase 1b participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).|||percentage of participants||95% Confidence Interval|Number
1354429|NCT01740128|Secondary|Change in Leg Spasticity on Modified Ashworth Scale|Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.|||units on a scale||Standard Deviation|Mean
1354494|NCT01738737|Secondary|Change From Baseline in Lequesne Functional Questionnaire|The scale varies from 0 to 24. Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||units on a scale||Inter-Quartile Range|Median
1354414|NCT01740297|Primary|Phase 2: Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) according to the modified immune-related response criteria (irRC) assessed by the investigator. Tumors were examined clinically and by computed tomography (CT) or magnetic resonance imaging (MRI).~CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. Response must have been confirmed by a repeat, consecutive assessment ≥ 4 weeks from the date first documented. Participants who did not have any follow-up tumor assessments were regarded as non-responders."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
1354415|NCT01740297|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities|"A DLT was defined as any toxicity related to study drug which met any of the following criteria based on Common Terminology Criteria for Adverse Events version 3.0:~treatment-related non-laboratory adverse events (AE) ≥ grade 4~≥ grade 4 immune-mediated dermatitis~≥ grade 4 immune-mediated endocrinopathy (except autoimmune thyroiditis)~≥ grade 3 immune-mediated enterocolitis~≥ grade 3 immune-mediated hepatitis (except grade 3 that resolved to grade 1 or baseline within 28 days of onset)~≥ grade 3 immune-mediated neuropathy~≥ grade 3 other immune-mediated AEs including hemolytic anemia, angiopathy, myocarditis, pericarditis, temporal arteritis, or vasculitis, autoimmune thyroiditis (except grade 3 that resolved to grade 1 or baseline within 28 days of onset), blepharitis, conjunctivitis, episcleritis, iritis, scleritis, or uveitis, pancreatitis, meningitis, arthritis or polymyalgia rheumatic, nephritis, pneumonitis, psoriasis or leukocytoclastic vasculitis."|The DLT evaluation period was 6 weeks from the initial administration of ipilimumab (week 6 to 12).|All phase 1b participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).|||participants|||Number
1354416|NCT01740206|Secondary|mYPAS Measurement in Patients Not Receiving Midazolam|"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction.~Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety."|Day 1|Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure.|||scores on a scale||Inter-Quartile Range|Median
1354417|NCT01740206|Secondary|mYPAS Measurement in Patients Receiving Midazolam|"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction.~Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety."|Day 1|Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure.|||scores on a scale||Inter-Quartile Range|Median
1354418|NCT01740206|Secondary|Mean Blood Pressure|Mean blood pressure prior to anesthetic induction|Day 1||||mmHg||Standard Deviation|Mean
1354419|NCT01740206|Secondary|Diastolic Blood Pressure|Diastolic blood pressure prior to anesthetic induction|Day 1||||mmHg||Standard Deviation|Mean
1354420|NCT01740206|Secondary|Systolic Blood Pressure|Systolic blood pressure prior to anesthetic induction|Day 1||||mmHg||Standard Deviation|Mean
1354421|NCT01740206|Primary|Heart Rate|Heart rate prior to anesthetic induction|Day 1||||BPM||Standard Deviation|Mean
1354422|NCT01740128|Secondary|Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)|Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.|||units on a scale||Standard Deviation|Mean
1354423|NCT01740128|Secondary|Change From Baseline in Soleus H-reflex Facilitation.|Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.|Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to lack of soleus H-reflex in several subjects.|||percentage of control reflex size||Standard Error|Mean
1354424|NCT01740128|Secondary|Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.|"Seated posturography performed using the Limits of Stability module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure."|Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing.|||Percentage of perfect path to target||Standard Error|Mean
1354425|NCT01740128|Secondary|Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).|Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.|||units on a scale||Standard Deviation|Mean
1354426|NCT01740128|Secondary|Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.|Change between baseline and Evaluation #2 in steps taken during 10-second step test.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Low number of participants able to perform seated steps at baseline.|||steps||Standard Error|Mean
1354427|NCT01740128|Secondary|Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.|Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Insufficient number of participants able to walk at baseline. Measure not recorded by Investigating team.||||||
1354428|NCT01740128|Secondary|Change in Gait Speed on 10-meter Walk Test.|Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Insufficient number of participants able to walk at baseline.|||meters per second||Standard Deviation|Mean
1354430|NCT01740128|Secondary|Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.|Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing|||units on a scale||Standard Deviation|Mean
1354431|NCT01740128|Secondary|Change From Baseline in ISNCSCI Lower Extremity Motor Score.|Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|One subject in multimodal group failed to appear for post-intervention testing for this outcome.|||units on a scale||Standard Deviation|Mean
1354432|NCT01740128|Primary|Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.|Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Only two participants in the study had consistent MEPs at baseline.|||Amplitude percentage of Mmax|||Number
1354433|NCT01740089|Other Pre-specified|Immunogenicity|Number of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.|Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment||||participants|||Number
1354434|NCT01740089|Secondary|Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.||After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.||||participants|||Number
1354435|NCT01740089|Secondary|Number of Randomized Patients Achieving Sustained Virologic Response (SVR) – Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.||24 weeks after last dose of study treatment||||participants|||Number
1354436|NCT01740089|Secondary|Number of Randomized Patients Achieving Rapid Virologic Response (RVR) – Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.||4 weeks||||participants|||Number
1354437|NCT01740089|Primary|Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.||12 weeks||||participants|||Number
1354438|NCT01739803|Secondary|Days in Hospital|"We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit.~Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period."|12 months||||percentage of participants|||Number
1354439|NCT01739803|Secondary|Health-related Quality of Life (HQoL)|The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting “no problems,” “some problems,” and “extreme problems.” A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death.|12 months||||units on a scale||Standard Deviation|Mean
1354440|NCT01739803|Primary|Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period|"Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days’ supply of IST, the participant’s adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days’ supply, the adherence rate was calculated as follows:~1 – [(Days Between Refills – Total Days Supply)/Days Between Refills] = Adherence Rate for Quarterly Time Period~At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period."|12 months|Intention to treat, as per protocol|||medication possession ratio (proportion)||Standard Deviation|Mean
1354441|NCT01739790|Primary|Changes in the Saint George's Respiratory Questionnaire|The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.|Baseline to 8 weeks||||units on a scale||Standard Deviation|Mean
1354442|NCT01739595|Primary|Change in Sperm Concentration|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT|||percentage of subjects|||Number
1354443|NCT01739595|Primary|Subjects With Testosterone in Normal Range After Treatment|"Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.|||Percentage of Subjects||95% Confidence Interval|Number
1354447|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Mini-Mental State Examination (MMSE) Score|Least squares mean change from baseline at week 78 was assessed for MMSE score. The MMSE is a cognitive assessment of 5 domains including: orientation; attention; memory; language; and constructional praxis. These domains are assessed over the course of 11 total questions related to the participant. Participants are scored based on the number of correct responses; depending on the question, potential scores range from 0 (no correct response) to either 1 (4 questions), 2 (1 question), 3 (3 questions), or 5 (3 questions). Scores from each question are summed to the total MMSE score, with total scores ranging from 0-30. Higher scores indicate better cognitive performance. Further, deterioration in cognitive performance would be reflected by decreases in MMSE score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1354448|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Neuropsychiatric Inventory (NPI) Score|Least squares mean change from baseline at week 78 was assessed for NPI score. NPI is a clinical assessment of psychiatric status, covering 12 domains: delusion; hallucination; agitation/aggression; depression/dysphoria; anxiety; elation/euphoria; apathy/indifference; disinhibition; irritability/lability; aberrant motor behavior; sleep/nighttime behaviors; and appetite/eating disorders. Based on an interview of the participant’s caregiver, each domain is assessed for symptom frequency [range: 1 (occasional) to 4 (very frequent)] and severity [range: 1 (mild) to 3 (severe)]. Domain scores [range: 0 to 12] are calculated as the product of the frequency and severity scores (i.e. frequency x severity); if no symptoms are present, domain score is 0. The 12 domain scores sum to a total NPI score [range: 0 (no symptoms in any domain) to 144]. Higher scores reflect more severe psychiatric impairment, with increases in impairment reflected by increases in NPI score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1354449|NCT01739348|Secondary|[Part I (Base Study)] Percentage of Participants Achieving Responder Status|The percentage of participants achieving responder status at week 78 was assessed. To determine which participants were considered responders, a linear regression was conducted at the participant level, yielding an estimated 78-week rate of change (i.e., a slope) for each participant with respect to ADAS-Cog and ADCS-ADL. To be declared a responder, a participant must have: 1) ADAS-Cog and ADCS-ADL observations at baseline and 78 weeks of treatment; 2) an ADAS-Cog slope > 4.0 over 78 weeks, and 3) an ADCS-ADL slope > -6.3 over 78 weeks. A participant failing to meet any of these criteria was designated as a non-responder at Week 78.|Week 78|All randomized participants in Part I receiving ≥1 dose of trial treatment. Per protocol, the first 200 participants enrolled prior to IA (across all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded from analysis.|||Percentage of Participants|||Number
1354450|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Cortical Amyloid Load Assessed by [18F]Flutemetamol PET Standard Uptake Value Ratio (SUVR)|Least squares mean change from baseline at week 78 was calculated for SUVR, a measure of brain cortical amyloid load. Per protocol, SUVR was analyzed as part of a substudy in Part I, with testing occurring only at select trial sites. Participants receive the PET tracer [18F]Flutemetamol (IV). After 90 minutes, participants receive 4 PET scans (5 minutes each in duration). Using these PET scan images, specific brain ROIs (frontal, temporal, and parietal lobes; anterior and posterior cingulate and precuneus) are used to calculate regional SUVRs, defined as the relative ratio of pixel intensities at a specific ROI compared to a reference region (RR; subcortical white matter). These regional SUVRs are then averaged to compute a composite cortical SUVR for each participant. Higher composite cortical SUVR values indicate increased amyloid load, with negative changes in composite cortical SUVR over time indicating decreases in brain amyloid load.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat did not receive SUVR testing and were excluded.|||SUVR||95% Confidence Interval|Least Squares Mean
1354451|NCT01739348|Secondary|[Part I (Base Study)] Fold Change From Baseline in Cerebrospinal Fluid (CSF) Total Tau|Least squares mean fold change from baseline at week 78 was calculated for Total Tau concentration in CSF, a measure of brain tau pathology. Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring only at select trial sites. Least squares mean fold change from baseline >1 indicates increased Total Tau concentration in the CSF.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window CSF Total Tau observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Fold Change||95% Confidence Interval|Least Squares Mean
1354452|NCT01739348|Secondary|[Part I (Base Study)] Percent Change From Baseline in Total Hippocampal Volume (THV)|Least squares mean percent change from baseline at week 78 was calculated for Total Hippocampal Volume (THV) as measured by volumetric magnetic resonance imaging (vMRI). Longitudinal analysis of within-participant THV is computed using a change analysis algorithm using tensor-based morphometry. This technique produces one measure of volume change calculated from the registration of serial vMRI scans at the follow-up time point relative to baseline. Negative percent changes from baseline indicate decreases in THV (i.e. increased hippocampal atrophy).|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window THV observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Percent Change||95% Confidence Interval|Least Squares Mean
1354495|NCT01738737|Secondary|Change From Baseline in Range of Motion of Flexion of the Knee|Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||degress||Inter-Quartile Range|Median
1354947|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Discontinuation||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.|||Percentage of participants|||Number
1354453|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score|Least squares mean change from baseline at week 78 was assessed for CDR-SB score. The CDR-SB score is a clinical rating of global cognitive function, comprised of 6 domains including: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care. For each domain, the degree of impairment is assessed by a semi-structured interview of the participant as well as the participant’s caregiver. For each domain, potential scores range from 0 (no impairment) to 3 (severe impairment). Scores from each individual domain are summed to the total CDR-SB score, with total scores ranging from 0-18. Higher scores indicate more severe cognitive impairment. Further, increases in cognitive impairment would be reflected by increases in CDR-SB score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window CDR-SB observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1354454|NCT01739348|Primary|[Part II (Extension Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event|The number of participants discontinuing from study drug due to an AE in Part II was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product is also an AE.|From week 78 (end of treatment in Part I) up to week 260 of Part II|Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect treatment discontinuations occurring in Part II only.|||Participants|||Count of Participants
1354455|NCT01739348|Primary|[Part I (Base Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event|The number of participants discontinuing from study drug due to an AE in Part I was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product is also an AE.|Up to week 78|Includes all randomized participants in Part I receiving ≥1 dose of trial treatment.|||Participants|||Count of Participants
1354456|NCT01739348|Primary|[Part II (Extension Study)] Number of Participants Who Experienced an Adverse Event|The number of participants experiencing an adverse event (AE) in Part II was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product is also an AE.|From week 78 (end of treatment in Part I) up to week 262 of Part II|Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect AEs occurring in Part II only.|||Participants|||Count of Participants
1354457|NCT01739348|Primary|[Part I (Base Study)] Number of Participants Who Experienced an Adverse Event|The number of participants experiencing an adverse event (AE) in Part I was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product is also an AE.|Up to week 80 (up to 2 weeks following cessation of study treatment in Part I)|Includes all randomized participants in Part I receiving ≥1 dose of trial treatment.|||Participants|||Count of Participants
1354458|NCT01739348|Primary|[Part II (Extension Study)] Change From Baseline in Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|Mean change from baseline at week 104 was assessed for the ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score. Per study protocol, the baseline measurement to be used was the baseline measurement obtained in Part I.|Baseline and week 104|All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population), having an ADCS-ADL observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded.|||Score on a Scale||Standard Deviation|Mean
1354465|NCT01739335|Other Pre-specified|Change in Plasma Cortisol From Baseline to 1-Week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates increased cortisol level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|Baseline to 1-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 1-week blood collection on cortisol were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||ug/dl||Inter-Quartile Range|Median
1354459|NCT01739348|Primary|[Part II (Extension Study)] Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Mean change from baseline at week 104 was assessed for the ADAS-Cog score. ADAS-Cog measures cognition by assessing 11 metrics impaired in Alzheimer’s Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog score. Per study protocol, the baseline measurement to be used was the baseline measurement obtained in Part I.|Baseline and week 104|All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population), having an ADAS-Cog observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded.|||Score on a Scale||Standard Deviation|Mean
1354460|NCT01739348|Primary|[Part I (Base Study)] Change From Baseline in Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|Least squares mean change from baseline at week 78 was assessed for the ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1354461|NCT01739348|Primary|[Part I (Base Study)] Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Least squares mean change from baseline at week 78 was assessed for the ADAS-Cog score. ADAS-Cog measures cognition by assessing 11 metrics impaired in Alzheimer’s Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1354462|NCT01739335|Other Pre-specified|Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 4-week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|Baseline to 4-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week blood collection on ACTH were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||pg/ml||Inter-Quartile Range|Median
1354463|NCT01739335|Other Pre-specified|Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 1-week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|baseline to 1-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 1-week blood collection on ACTH were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||pg/ml||Inter-Quartile Range|Median
1354464|NCT01739335|Other Pre-specified|Change in Plasma Cortisol From Baseline to 4-Week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased cortisol level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|Baseline to 4-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week blood collection on cortisol were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||ug/dl||Inter-Quartile Range|Median
1354487|NCT01738919|Secondary|Complications|Number of participants with nail deformities.|6 month||||participants|||Number
1354488|NCT01738919|Secondary|Bump|Number of participants with the presence of a bump on the fracture-site.|6 month||||participants|||Number
1354489|NCT01738919|Secondary|Pain|Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0–10, with 0 indicating no pain.|6 month||||units on a scale||Inter-Quartile Range|Median
1354490|NCT01738919|Primary|Extension Deficit in the Affected Distal Interphalangeal Joint.|Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)|6 month||||degrees extension deficit||95% Confidence Interval|Mean
1354466|NCT01739335|Other Pre-specified|Change in Anger Level (Measured by the STAXI Total Score) From Baseline to 4-Week and 12-Week|The State-Trait Anger Expression Inventory (STAXI) total score is the sum of 10 items assessing intensity of anger as an emotional state (State Anger) and the disposition to experience angry feelings as a personality trait (Trait Anger). Each item consists of a 4-point scale (1=not at all, 4=very much) that assess intensity of anger at a particular moment and the frequency of anger experience, expression and control. The STAXI total score ranges from 10 to 40, with a higher score indicating a higher intensity of anger.The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased STAXI total score (i.e., higher intensity of anger) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|Baseline to 4-week and 12-week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354467|NCT01739335|Other Pre-specified|Change in Sleep Quality (Measured by the PSQI Total Score) From Baseline to 4-Week and 12-Week|The Pittsburgh Sleep Quality Index (PSQI) assesses self-report sleep quality and disturbances. Nineteen individual items generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. Each component is scored from 0=better to 3=worse. The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased PSQI total score (i.e., worse sleep quality) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354468|NCT01739335|Other Pre-specified|Changes in PTSD Symptom Severity (Measured by the Stressful Life Total Score From the PTSD Checklist) From Baseline to 4-Week and 12-Week|"Stressful life total score (ranges 17-85) is the sum of the severity ratings of the 17 PTSD-related symptoms (each symptom is rated on a 5-point scale of 1=not at all to 5=extremely) over the past week. It evaluates the extent to which responders have been bothered by the symptoms of PTSD. The higher stressful life score indicates more stressful life events. A positive change score indicates an increased stressful life total score (i.e., more stressful life events) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction."|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354469|NCT01739335|Other Pre-specified|Change in Depression (Measured by the BDI Total Score) From Baseline to 4-Week and 12-Week|The Beck Depression Inventory (BDI) total score (ranges 0-63) is the sum of 21 items (each item rated on a 4-point scale of 0 to 3) relating to symptoms of depression, cognitions, and physical symptoms. The BDI total score measures the overall severity of depression. The higher the BDI total score, the more severe the depression. A positive change score indicates an increased BDI total score (i.e., more severe depression) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354470|NCT01739335|Other Pre-specified|Change in CAPS Hyperarousal Symptom Scores From Baseline to 4-Week and 12-Week|The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its hyperarousal symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the hyperarousal symptom subcategory. A higher hyperarousal symptom score indicates worse PTSD symptoms. A positive change score indicates an increased hyperarousal symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354471|NCT01739335|Other Pre-specified|Change in CAPS Avoidance Symptom Scores From Baseline to 4-Week and 12-Week|"The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its avoidance symptom subscale (ranges 0 - 56) is the sum of 7 PTSD symptoms (each ranges 0 - 8) in the avoidance/emotional numbing symptom subcategory. A higher avoidance symptom score indicates worse PTSD symptoms. A positive change score indicates an increased avoidance symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.~The higher is the avoidance/emotional numbing PTSD subscale score, the worse is the PTSD symptom."|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354491|NCT01738750|Secondary|Hospital/Operative Dollars|A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups|Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year||||Dollar||Inter-Quartile Range|Median
1354492|NCT01738750|Primary|Choice Based on Cost|The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information|Outcome assessed prior to surgical procedure with data presented within 1 year||||percentage of open appendectomy|||Number
1354472|NCT01739335|Other Pre-specified|Change in CAPS Intrusive Symptom Scores From Baseline to 4-Week and 12-Week|The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its intrusive symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the intrusive/re-experiencing symptom subcategory. A higher intrusive symptom score indicates worse PTSD symptoms. A positive change score indicates an increased intrusive symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354473|NCT01739335|Secondary|Change in CAPS Total Score From Baseline to 4-week and 12-week|The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score ranges 0 to 136, which is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). A higher CAPS total score indicates worse PTSD symptoms. A positive change score indicates an increased CAPS total score (i.e., worse PTSD symptoms) at 4-week (12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% Confidence Interval (CI) reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1354474|NCT01739335|Secondary|Percentage of Clinical Responders at 12-week Follow-up (End of Study)|A clinical responder at 12-week is defined as a participant who achieves a 30% or greater reduction in CAPS total score (past week symptom status) from baseline to 12-week follow-up. The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score (ranges 0 - 136) is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). The higher is the CAPS total score, the worse is the PTSD symptom. Higher percentage of responders indicate a better drug effect in treating PTSD symptoms.|week 12|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 12-week CAPS assessment were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||Participants|||Count of Participants
1354475|NCT01739335|Primary|Percentage of Clinical Responders at 4-week Follow-up|A clinical responder at 4-week is defined as a participant who achieves a 30% or greater reduction in CAPS total score (past week symptom status) from baseline to 4-week follow-up. The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score (ranges 0 - 136) is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). The higher is the CAPS total score, the worse is the PTSD symptom. Higher percentage of responders indicate a better drug effect in treating PTSD symptoms.|week 4|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week CAPS assessment were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||Participants|||Count of Participants
1354476|NCT01738984|Other Pre-specified|Return to Drinking Between Baseline and 12 Weeks|drinking status measured via online survey taken at baseline and 12 week|12 weeks|number of participants who never/rarely drank at baseline but reported drank 1 or more drink per week at 12 weeks.|||participants|||Number
1354477|NCT01738984|Secondary|Number Who Returned to Smoking From Baseline and 12 Weeks|change in smoking status between baseline and 12 week assessment will be collected via survey at baseline and at the 12 week survey|12 weeks|Number of participants who were not smoking at baseline but reported returned to smoking on 12 week survey.|||participants|||Number
1354478|NCT01738984|Primary|Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks|physical activity will be obtained via online surveys at the 12 week assessment point|12 weeks||||MVPA minutes per week||95% Confidence Interval|Mean
1354479|NCT01738971|Other Pre-specified|Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties||12 months|||||||
1354480|NCT01738971|Other Pre-specified|Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews.||8 months|||||||
1354481|NCT01738971|Secondary|Proportion of Women Who Agree to Participate Who Can be Successfully Contacted||8 months||||participants|||Number
1354482|NCT01738971|Secondary|Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)||8 months|||||||
1354483|NCT01738971|Secondary|Pharmacy Recruitment Rates|Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group.|8 months||||participants|||Number
1354484|NCT01738971|Primary|Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)|Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.|6-8 weeks after EC|A small number of participants were identified who had been recruited to the study although were already using an effective method of contraception (i.e. using a contraceptive pill but had forgot to take), and continued to use the same method at follow-up. These participants were excluded from analysis.|||participants|||Number
1354485|NCT01738919|Secondary|Flexion of the Distal Interphalangeal Joint.|Flexion of the distal interphalangeal joint. Measured with goniometer.|6 months||||degrees||95% Confidence Interval|Mean
1354486|NCT01738919|Secondary|DASH|Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0–100, with 0 indicating no disability.|6 month||||units on a scale||Inter-Quartile Range|Median
1354496|NCT01738737|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index|The scale varies from 0 to 96. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||units on a scale||Inter-Quartile Range|Median
1354497|NCT01738737|Primary|Change From Baseline in Visual Analogue Scale for Pain|The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||units on a scale||Standard Deviation|Mean
1354498|NCT01738698|Secondary|Ambulatory Blood Pressure Monitoring (ABPM)||Baseline and Weeks 4 and 10|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354499|NCT01738698|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354500|NCT01738698|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354501|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354502|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 12|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354503|NCT01738698|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354504|NCT01738698|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354505|NCT01738698|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354506|NCT01738698|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354507|NCT01738698|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354508|NCT01738698|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354509|NCT01738698|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354510|NCT01738698|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354511|NCT01738698|Secondary|Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354512|NCT01738698|Primary|Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
1354513|NCT01738672|Other Pre-specified|Crossover To Epidural|Participants crossing over from nitrous oxide to epidural.|Initiation of nitrous oxide to completion of delivery.|Data are included for all participants from which they were collected.|||participants|||Number
1354514|NCT01738672|Other Pre-specified|Participant Satisfaction|Participant reported score of satisfaction with nitrous oxide for labor analgesia, using a numerical rating scale (NRS) ranging from completely dissatisfied (0) to completely satisfied (100).|24 hours after delivery|Data are included for all participants from which they were collected.|||units on a scale||Full Range|Median
1354515|NCT01738672|Other Pre-specified|Emesis|Participant reported emesis (yes or no).|During administration of nitrous oxide|Data are included for all participants from which they were collected.|||participants experiencing emesis|||Number
1354516|NCT01738672|Other Pre-specified|Nausea|Participant reported nausea score, using a numerical rating scale (NRS) ranging from no nausea (0) to severe nausea (10).|At baseline, and at 1 hour after initiation of nitrous oxide|Data are included for all participants from which they were collected.|||units on a scale||Standard Deviation|Mean
1354517|NCT01738672|Other Pre-specified|Anxiety|Participant reported anxiety score, using a numerical rating scale (NRS) ranging from no anxiety (0) to severe anxiety (10).|At baseline, and at 1 hour after initiation of nitrous oxide|Data are included for all participants from which they were collected.|||units on a scale||Standard Deviation|Mean
1354518|NCT01738672|Primary|Labor Pain|Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).|At baseline, and at 1 hour after initiation of nitrous oxide|Data are included for all participants from which they were collected.|||units on a scale||Standard Deviation|Mean
1354519|NCT01738646|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|3 Years|Intent-to-treat|||months||95% Confidence Interval|Median
1354520|NCT01738646|Secondary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.|3 Years|Intent-to-treat|||months||95% Confidence Interval|Median
1354521|NCT01738646|Secondary|Percentage of Participants Who Experience Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|The percentage of participants who experience grade 3 or greater, treatment-related, non-hematologic toxicities will be calculated.|2.7 Years|Intent-to-treat|||percentage of participants|||Number
1354522|NCT01738646|Secondary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter.|3 Years|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1354523|NCT01738646|Primary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1354524|NCT01738581|Secondary|Change From Baseline in Physical Function at Posttest (Day 5)|Participants completed the full SF-36 assessment with subsection of interest: “physical functioning”.|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
1354525|NCT01738581|Secondary|Change From Baseline for Physician Rated Impairment at Posttest (Day 5)|Video recordings were made as participants wrote on a pad of paper with pen. Participants were asked to draw a series of 10 loops across the pad of paper followed by “The dog is barking” and their signature, each repeated four times. A physician blinded to participant allocation rated recordings. Scoring criteria were adapted from a standardized writer's cramp rating scale (WCRS) (Wissel et al., 1996), rating pathological flexion or extension at the wrist, fingers and elbow, presence of tremor, dystonic posture, writing speed and latency of dystonic symptoms. Final scores are expressed as a rating listed as a movement score.|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
1354526|NCT01738581|Secondary|Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)|Digitized handwriting was assessed using a computerized tablet (WACOM Co., Ltd., japan) with MovAlyzeR® (Neuroscript LLC, Tempe, AZ) hardware and software. Participants used a custom modified digitized pen (Kiko Software, Netherlands) to write in a self-selected pace and style on the tablet with real-time visual feedback. Writing tasks included “My country tis of thee” at a self-selected pace, repeated eight times. Data were sampled at 215 Hz (resolution: 5080 lpi, accuracy: ±0.01 pressure range: 0–800 g). Writing samples were segmented by points of minimal velocity into single strokes for analysis. Pressure for each stroke was automatically calculated within the software.|Baseline and Posttest|One participant that did not display symptoms affecting handwriting and did not participate in the handwriting analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
1354527|NCT01738581|Secondary|Change From Baseline in Cortical Silent Period at Posttest (Day 5)|"Cortical silent period (CSP) testing was completed during an isometric contraction of the target muscle whereby the motor evoked potential is followed by a short duration of electromyographic quiescence. The maximal voluntary contraction for finger abduction was recorded using a custom strain gauge placed around the index finger. Real-time visual feedback was given on a laptop screen to project the force produced by the participant and 20% of the maximum of three trials was calculated and displayed on a target line. For the CSP, participants were asked to contract until the target line was met, then a single transcranial magnetic stimulation pulse was delivered to the motor cortex. Ten trials were collected with a short rest period to prevent fatigue.~CSP duration was calculated in milliseconds (ms). CSP EMG data were first rectified, and then a 10-ms moving average calculation was applied to the data. The onset of the CSP was set as the time point of the delivery of the TM"|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
1354528|NCT01738581|Secondary|Change From Baseline in Sensation at Posttest (Day 5)|Examinations included two point discrimination. Two-point discrimination threshold was completed using a Disk-Criminator™. Participants were asked to reply “one” or “two” after each presentation. Static and dynamic stimuli were presented to the index and ring fingers bilaterally, meaning it was presented as a static stimuli or it was slowly swept across the skin (dynamic).|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
1354598|NCT01737996|Secondary|Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354529|NCT01738581|Secondary|Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)|The Arm Dystonia Disability Scale (ADDS) is a survey where participants rate task difficulty for activities such as writing, handling utensils, and buttoning on a scale of 1–4 (1 = no difficulty ,4 = not able or marked difficulty). This is a subjective assessment of impairment due to focal hand dystonia. Scores are determined using an equation: total points scored, divided by the maximum possible (23), multiplied by the quotient by 90 and subtract from 90%. Scores range from 0%-90% with higher scores indicating more function.|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||percentage of function||Standard Deviation|Mean
1354530|NCT01738581|Primary|Change From Baseline in Global Rating of Change at Posttest (Day 5)|Symptom severity was assessed using the global rating of change (GROC). For the GROC, participants were asked to identify between one to three functions most impacted by focal hand dystonia. At posttest 1 they were then asked to select a rating of perceived change that represented the level of function compared to baseline. Perceived change consisted of a ±7 point Likert scale (+7= a very great deal better, 0= no change, -7= a very great deal worse).|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||units on a scale||Full Range|Mean
1354531|NCT01738503|Secondary|Percentage of Urine Drug Screen Samples Negative for Opioids|"Urine samples were screened for the following drugs:~opiates~cocaine~amphetamines~methadone~cannabinoids~barbiturates~buprenorphine. Buprenorphine was only included in the urine drug screen at screening and Day -14 to determine if the subject had used any buprenorphine-containing products prior to the start of SUBUTEX SL tablet dosing.~benzodiazepines~methamphetamine~phencyclidine~Urine drug screens were run every day when the participant was an inpatient; every 2-3 days when the participant was an outpatient. Drug screens were run less often for those participants in the PET substudy."|Day 1 to End of Study (up to day 365)|Safety population|||percentage of total urine drug samples||Standard Deviation|Mean
1354532|NCT01738503|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS): Severity|The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent.|Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)|PD population|||units on a scale||Standard Deviation|Mean
1354533|NCT01738503|Secondary|Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141|"The CGI-I is a 7-item scale completed by the clinician used to rate their impression of how much the participant has improved over a baseline state. The total range is 1 (very much improved) to 7 (very much worse).~Baseline was defined as value from Day 1. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate an improvement."|Baseline (Day 1), Days 7, 29, 57, 85, 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter. One participant from Group 6 did not have a baseline evaluation.|||units on a scale||Standard Deviation|Mean
1354534|NCT01738503|Secondary|Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141|"The CGI-S is a 7-item scale completed by the clinician used to rate the severity of symptoms. The total range is 1 (normal, not at all ill) to 7 (most extremely ill).~Baseline was defined as value from screening (Day -13). The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate a lessening of the severity of symptoms."|Baseline (screening Day -15), Days 1, 7, 29, 57, 85, 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter. One participant from Group 2 did not have a baseline evaluation.|||units on a scale||Standard Deviation|Mean
1354535|NCT01738503|Secondary|Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6|"The Total Score was the sum of 10 questions regarding cravings each ranging from 0 (no craving) - 10 (extreme craving) for a total range from 0 (no cravings) to 100 (most intense craving I have ever had).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of craving symptoms."|Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.|||units on a scale||Standard Deviation|Mean
1354536|NCT01738503|Secondary|Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6|"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms."|Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.|||units on a scale||Standard Deviation|Mean
1354569|NCT01738477|Secondary|Anti-D and Anti-T Antibody Concentrations.|Concentrations were expressed as GMCs.|At Month 0 and Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1354537|NCT01738503|Secondary|Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6|"COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. Each participant was to be assessed by the same qualified and trained individuals throughout the course of the study as much as possible.~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms."|Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.|||units on a scale||Standard Deviation|Mean
1354538|NCT01738503|Primary|Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4|The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.|Days 85-113, 141-197|PK population of participants whose data met requirements.|||hours||Standard Deviation|Mean
1354539|NCT01738503|Primary|Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞)|"Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 and 6 (last injection) in subjects not participating in PET imaging sub-study only as:~(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule."|Days 85-113, 141-197|PK population of participants whose data met requirements.|||hr*ng/mL||Standard Deviation|Mean
1354540|NCT01738503|Primary|Norbuprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))|Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
1354541|NCT01738503|Primary|Norbuprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))|Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
1354542|NCT01738503|Primary|Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)|"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hours||Full Range|Median
1354543|NCT01738503|Primary|Norbuprenorphine PK: Swing of Plasma Concentrations|"The swing of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||percentage of Cmin||Standard Deviation|Mean
1354544|NCT01738503|Primary|Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin)|"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
1354570|NCT01738477|Secondary|Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.|The cut-off of the assay was ≥ 1.0 IU/mL.|At Month 0 and Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
1355772|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
1354545|NCT01738503|Primary|Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax)|"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
1354546|NCT01738503|Primary|Norbuprenorphine PK: Average Plasma Concentration (Cavg)|"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
1354547|NCT01738503|Primary|Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)|"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hr*ng/mL||Standard Deviation|Mean
1354548|NCT01738503|Primary|Norbuprenorphine PK: % Fluctuation|"% Fluctuation was defined as the degree of fluctuation of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||% of average concentration||Standard Deviation|Mean
1354549|NCT01738503|Primary|Buprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4|The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.|Days 85-113|PK population of participants whose data met requirements.|||hours||Standard Deviation|Mean
1354550|NCT01738503|Primary|Buprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 (AUC0-∞)|"Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 (last injection) in subjects not participating in PET imaging sub-study only as:~(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule."|Days 85-113|PK population of participants whose data met requirements.|||hr*ng/mL||Standard Deviation|Mean
1354551|NCT01738503|Primary|Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6|Apparent clearance at steady-state (CLss/F) = Dose / AUCtau (tau was 28 days).|Days 85-113, 141-169|PK population|||L/hour||Standard Deviation|Mean
1354552|NCT01738503|Primary|Buprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))|Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
1354553|NCT01738503|Primary|Buprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))|Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
1354614|NCT01737931|Primary|Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)|"Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.~The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|24 hours after 2 mg/24 hr patch removal|FAS|||Scores on a scale||95% Confidence Interval|Mean
1354554|NCT01738503|Primary|Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)|"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hours||Full Range|Median
1354555|NCT01738503|Primary|Buprenorphine PK: Swing of Plasma Concentrations|"The swing of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||percentage of Cmin||Standard Deviation|Mean
1354556|NCT01738503|Primary|Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin)|"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
1354557|NCT01738503|Primary|Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax)|"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
1354558|NCT01738503|Primary|Buprenorphine PK: Average Plasma Concentration (Cavg)|"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
1354559|NCT01738503|Primary|Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)|"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hr*ng/mL||Standard Deviation|Mean
1354802|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Hematocrit||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||Percentage red blood cells||Inter-Quartile Range|Median
1354560|NCT01738503|Primary|Buprenorphine PK: % Fluctuation|"% Fluctuation was defined as the degree of fluctuation of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||% of average concentration||Standard Deviation|Mean
1354561|NCT01738503|Primary|Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following outcomes: death; lifethreatening AE; hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacit|Days -14 to -1 (Subutex treatment), Days 1-316 (RBP-6000 treatment)|Safety analysis group|||Participants|||Count of Participants
1354562|NCT01738477|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 31 days post-vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.|||Participants|||Count of Participants
1354563|NCT01738477|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31 days (Day 0 – 30) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.|||Participants|||Count of Participants
1354564|NCT01738477|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.|During the 4 days (Day 0 – 3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.|||Participants|||Count of Participants
1354565|NCT01738477|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.|During the 4 days (Day 0 – 3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.|||Participants|||Count of Participants
1354566|NCT01738477|Secondary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.|"Booster response to pertussis antigens was defined as:~for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination;~for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination;~for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination."|At Month 1.|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
1354567|NCT01738477|Secondary|Number of Subjects With a Booster Response to Anti-D and Anti-T.|"Booster response to anti-D and anti-T antigens was defined as:~for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination,~for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination."|At Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
1354568|NCT01738477|Secondary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).|Concentrations were expressed in geometric mean concentrations (GMCs).|At Month 0|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1354571|NCT01738477|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)|At Month 0|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
1354572|NCT01738477|Primary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).|Concentrations were expressed in geometric mean concentrations (GMCs).|At Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1354573|NCT01738477|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)|At Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
1354574|NCT01738438|Post-Hoc|15-Week Clinical Benefit Rate|The 15-week clinical benefit rate (CBR) was defined as absence of disease progression (PD) per RECIST1.1 criteria at the second disease assessment (week 15). Radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Confirmatory scans for response were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and week 15 on treatment.|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
1354575|NCT01738438|Secondary|Progression Free Survival|Progression-free survival (PFS) estimated using Kaplan-Meier methods was defined as the time from registration to documented disease progression (PD) or death. Based on RECIST1.1, radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients who were event-free were censored at the date of their last disease evaluation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1354576|NCT01738438|Primary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
1354577|NCT01738321|Primary|Change in Intracuff Pressure||1 day||||cmH2O||Standard Deviation|Mean
1354578|NCT01738191|Secondary|Change in WAIS-IV: Digit Span|"Wechsler Adult Intelligence Scale, fourth edition Digit Span | Scaled | age| 1-16~Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
1354579|NCT01738191|Secondary|Change in D-KEFS: Number-Letter Switching Time|"Delis-Kaplan Executive Function System Trail Making Number/Letter Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
1354580|NCT01738191|Secondary|Change in D-KEFS: Inhibition-Switching Time|"Delis-Kaplan Executive Function System Color-Word Inhibition/Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
1354581|NCT01738191|Secondary|Change in D-KEFS: Inhibition Time|"Delis-Kaplan Executive Function System Color-Word Inhibition Time | Scaled | age normed| range 1-16 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
1354582|NCT01738191|Secondary|Change in NAB: Part D|"Neuropsychological Assessment Battery Numbers & Letters D Efficiency | T-score| age & education normed| range 19-70~Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
1354583|NCT01738191|Secondary|Change in NAB: Part A|"Neuropsychological Assessment Battery Numbers & Letters A Efficiency | T-score| age & education normed| range 19-70~Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
1354584|NCT01738191|Secondary|Change in PASAT|"Paced Auditory Serial Addition Test 3-second interstimulus interval | Z-score| age & education normed| range -5 to +5 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
1354803|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||giga (10^9) cells per liter (Gi/L)||Inter-Quartile Range|Median
1354585|NCT01738191|Primary|The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests|Patients were ranked on each outcome and ranks were summed. The mean summed-ranks were compared by treatment group by a global statistical test (GST). Higher scores indicate better performance. The total summed-ranks range from 7 - 210 (7 outcomes x N=30).|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||summed-ranks||95% Confidence Interval|Mean
1354586|NCT01737996|Primary|Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)|Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354587|NCT01737996|Primary|AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)|Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354588|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354589|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354590|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354591|NCT01737996|Primary|C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)|"Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354592|NCT01737996|Primary|Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354593|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354594|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)|"Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354595|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354596|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354597|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354599|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354600|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354601|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354602|NCT01737996|Secondary|Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354603|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354604|NCT01737996|Primary|C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)|Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354605|NCT01737996|Primary|Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1354606|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)|Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.|PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354607|NCT01737996|Primary|Number of Healthy Subjects With AEs (Multiple Rising Dose Part)|Number of healthy subjects with any adverse event (AE) during the on-treatment period.|From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)|Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication.|||participants|||Number
1354608|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)|Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1354609|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng/mL/mg||Standard Deviation|Mean
1354610|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment|24 Hour period|Dose-normalized MTX PK parameter AUC(0-24)/Dose used for comparison|||ng*hr/mL/mg||Standard Deviation|Mean
1354611|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng*hr/mL/mg||Standard Deviation|Mean
1354612|NCT01737931|Secondary|Itching of Application Site Evaluated by VAS After Patch Removal|"Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods).~The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|Up to 96 hours after patch removal|FAS|||Scores on a scale||Standard Deviation|Mean
1354613|NCT01737931|Secondary|Skin Irritation Score After Patch Removal|Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.|Up to 72 hours after patch removal|FAS subjects with a score of ≥ 0.5 (±) at Day 3|||Percentage of participants|||Number
1354615|NCT01737931|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.~The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles."|24 hours after 2 mg/24 hr patch removal|Full analysis set (FAS) subjects with a score of ≥ 0.5 (±) at Day 3|||Scores on a scale||95% Confidence Interval|Mean
1354616|NCT01737879|Secondary|Peginesatide Dose by Visit||Baseline and Weeks 5, 9, 13, and 17|Primary analysis set, with available data at each time point (indicated by n)|||mg||Standard Deviation|Mean
1354617|NCT01737879|Secondary|Hemoglobin Concentration by Visit||Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21|"Primary analysis set includes all enrolled participants who received at least 1 dose of investigational product. The number of participants with available data at each time point is indicated by n."|||g/dL||Standard Deviation|Mean
1354618|NCT01737879|Secondary|Mean Dose of Epoetin Alfa During the Evaluation Period|No participant reached the evaluation period, therefore, this endpoint could not be evaluated.|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).|||||||
1354619|NCT01737879|Primary|Mean Hemoglobin Concentration During the Evaluation Period|"The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.~No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated."|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).|||||||
1354620|NCT01737840|Secondary|Need for Additional Drug|The investigators are measuring the need for additional drug at the end of 60 minutes.|60 th minute||||participants|||Number
1354621|NCT01737840|Primary|Visual Analogue Scale Score|The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain.|30th and 60th minutes||||Visual Analogue Scale||Standard Deviation|Mean
1354622|NCT01737762|Secondary|Time in Days to Closure|Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.|16 Weeks||||Days||Standard Deviation|Mean
1354623|NCT01737762|Primary|Wound Closure|Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.|16 Weeks||||participants|||Number
1354624|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354625|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354626|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354995|NCT01733953|Secondary|Change From Baseline in Carotid Artery Distensibility at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||% distensibility||95% Confidence Interval|Mean
1354627|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354628|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal – Influenza H1N1|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354629|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354630|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H3N2 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354631|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H1N1 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354638|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percent of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations|||percentage of participants|||Number
1354632|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular – Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza B at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354633|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H3N2 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H3N2 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H3N2 Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||HAI antibody titers||95% Confidence Interval|Geometric Mean
1354634|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H1N1 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H1N1 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations|||HAI antibody titers||95% Confidence Interval|Geometric Mean
1354635|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza B|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza B between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than 1 indicated an increase in HAI antibody titers against influenza B as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza B. Participants who achieved seroprotection (which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B) prior to vaccination were excluded from the analysis.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||HAI antibody titers||95% Confidence Interval|Geometric Mean
1354636|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H3N2|The difference in the percentage of participants that achieved seroprotection against influenza H3N2 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354637|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal – Influenza H1N1|The difference in the percentage of participants that achieved seroprotection against influenza H1N1 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 – 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
1354639|NCT01737684|Secondary|Apparent Terminal Half-life (t½) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr||Geometric Coefficient of Variation|Geometric Mean
1354640|NCT01737684|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr||Full Range|Median
1354641|NCT01737684|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
1354642|NCT01737684|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vd/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||L||Geometric Coefficient of Variation|Geometric Mean
1354643|NCT01737684|Secondary|Apparent Clearance (CL/F), Calculated as Dose/AUC0-∞, After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1354644|NCT01737684|Primary|Area Under the Concentration Time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included the subset of participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM•hr||95% Confidence Interval|Geometric Mean
1354645|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Prior to discharge, up to 3 hours after induction.||||units on a scale||Standard Deviation|Mean
1354646|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|45 minutes post-emergence|Participants not yet discharged at the 45 minute time point|||units on a scale||Standard Deviation|Mean
1354647|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|30 minutes post-emergence|Participants not yet discharged at the 30 minute time point|||units on a scale||Standard Deviation|Mean
1354648|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|15 minutes post-emergence|Participants not yet discharged at the 15 minute time point|||units on a scale||Standard Deviation|Mean
1354649|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|5 minutes post-emergence||||units on a scale||Standard Deviation|Mean
1354650|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Emergence (spontaneous extremity movement)||||units on a scale||Standard Deviation|Mean
1354663|NCT01737021|Secondary|Impact of Events Scale (IES)|Validated measure of post-traumatic stress symptoms in the parent.|3-6 months post discharge from PICU|||||||
1355065|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min||Standard Deviation|Mean
1354651|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Induction||||units on a scale||Standard Deviation|Mean
1354652|NCT01737593|Primary|Postanesthesia Emergence Agitation (EA) Score|"EA was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. This scale measures if the: 1. Child makes eye contact with the caregiver, 2. Child’s actions are purposeful, 3. Child is aware of his/her surroundings, 4. Child is restless, 5. Child is inconsolable.~Items 1, 2, and 3 are reversed scored as follows: 4 _ not at all, 3 _ just a little, 2 _ quite a bit, 1 _ very much, 0 _ extremely. Items 4 and 5 are scored as follows: 0 _ not at all, 1 _ just a little, 2 _ quite a bit, 3 _ very much, 4_extremely. Scores of each item are summed to obtain a total PAED scale score, range 0-20, with higher PAED scores indicating a greater degree of emergence delirium.~The average PAED score of all the time points is use"|Induction,Emergence(spontaneous extremity movement),and every 5 min after emergence until the patient is discharged. This is an average of 3 hours till discharge.||||units on a scale||Standard Deviation|Mean
1354653|NCT01737268|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, re quire d or prolonged hospitalization or was considered medically important.|From first dose of study drug up to week 52 (52 weeks)|Safely Analysis Set (SAF), which included participants who received at least one dose of study drug.|||Participants|||Count of Participants
1354654|NCT01737268|Secondary|CGI-BP-C: Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354655|NCT01737268|Secondary|CGI-BP-C: Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354656|NCT01737268|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354657|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354658|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354659|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354660|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354661|NCT01737268|Primary|Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
1354662|NCT01737021|Secondary|Hospital Anxiety and Depression Scale (HADS)|Validated measure of anxiety and depression in the parent.|3-6 months post discharge from PICU|||||||
1354664|NCT01737021|Primary|The Number of Feasibility Criteria Successfully Met|"Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection.~Dependent on the number of criteria successfully met, the following classification will be used:~0-2/6 criteria met - Stop; intervention and/or study design not feasible.~3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications.~5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring.~6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is."|3-6 months post discharge from PICU||||Number of criteria successfully met|||Number
1354665|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days||||number of mornings|Participants||Number
1354666|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days||||number of mornings|Participants||Number
1354667|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days||||number of mornings|Participants||Number
1354668|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days||||number of mornings|Participants||Number
1354669|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days||||number of mornings|Participants||Number
1354670|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days||||number of mornings|Participants||Number
1354671|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days||||percentage of mornings|Participants||Number
1354672|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days||||percentage of mornings|Participants||Number
1354673|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
1354674|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
1354675|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
1354676|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||mg/dl|Participants|Standard Deviation|Mean
1354677|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||mg/dl|Participants|Standard Deviation|Mean
1354678|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||mg/dl|Participants|Standard Deviation|Mean
1354679|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days||||percentage of mornings|Participants||Number
1354680|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 3|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3."|21 study nights||||mg/dl|Participants|Standard Deviation|Mean
1354681|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 2|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2."|21 study nights||||mg/dl|Participants|Standard Deviation|Mean
1354682|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 1|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes."|21 study nights||||mg/dl|Participants|Standard Deviation|Mean
1354683|NCT01736917|Secondary|Self-Reported Assessment of Nausea|"the patient’s self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.~The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day."|Days 1-8 of chemotherapy regimen|54 patients completed the VAS on all 8 days and were eligible for analysis.|||millimeters||Full Range|Median
1354684|NCT01736917|Secondary|Use of Rescue Medications.|Total number of patients who received rescue medications.|Days 1-8 of chemotherapy regimen||||participants|||Number
1354685|NCT01736917|Secondary|Total Number of Emetic Episodes|total number of emetic episodes|Days 1-8 of chemotherapy regimen||||episodes|||Number
1354686|NCT01736917|Primary|Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting|complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications|Days 1-8 of chemotherapy regimen||||percentage of participants|||Number
1354687|NCT01736696|Secondary|Gene Expression in Peripheral Blood|Punch biopsy and serum blood were assayed for messenger Ribonucleic acid (mRNA) gene expression by quantitative PCR using standard curve(SC) method generated by linear regression using log threshold cycle versus log(cell number). granzyme B, IFN-gamma, TNF-alpha (FasL and superfamily member 5 [SF5]), BCL2, BAX, iNOS, and CD 25 presented as control gene normalized expression(relative expression) within SC. The Relative mRNA Gene Expression Level is relative to baseline and normalized to the housekeeping gene 18 Svedberg unit ribosomal RNA (18S rRNA).|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.|||relative expression unit (REU)||Standard Deviation|Mean
1354688|NCT01736696|Secondary|Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against ICAM-1. Number of participants with ICAM-1 expression was to be assessed qualitatively using epidermal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis of ICAM-1 in biopsy specimens was not performed as it often continues to be expressed on vessels in the skin even when psoriasis was resolved, thus would not provide a measure of response to therapy.||||||
1354689|NCT01736696|Secondary|Number of Participants With Keratin 16 (K16) Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against K16. Number of participants with K16 expression were assessed qualitatively using suprabasal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1354690|NCT01736696|Secondary|Immunohistochemistry From Psoriatic Plaque Biopsies|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against cluster of differentiation 3 (CD3) and cluster of differentiation 8 (CD8) T-lymphocytes, cluster of differentiation 16/56 (CD16/56) natural killer cells, and cluster of differentiation 83 (CD83) mature dendritic cells. Baseline was defined as mean of samples obtained at the screening visit within 7 days prior to Day 1, at the baseline biopsy, and Day 0. Immunohistochemistry results were planned to be analyzed for participants who received CP-690,550 5, 20, 30 mg and matching placebo.|Baseline (within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.|||cells/microliter (cells/μL)||Standard Deviation|Mean
1354691|NCT01736696|Secondary|Gene Expression in Psoriatic Plaque Biopsies|Gene expression by quantitative polymerized chain reaction (PCR) using standard curve (SC) method generated by linear regression using log threshold cycle versus log(cell number). Keratin (K)-16, inducible nitric oxide synthase (iNOS), Interleukin 8 (IL-8), CD25, Granzyme B, IL-2, IL-7, IL-15, Interferon-gamma (INF-gamma), C-X-C motif chemokine(CXCL10), perforin 1, B-cell Lymphoma 2 (BCL-2), BCL2 associated X Protein (BAX), Tumor Necrosis Factor Fas Ligand (TNF-FasL), and proliferating cell nuclear antigen (PCNA) presented as control gene normalized expression (relative expression) within SC.|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.|||relative expression unit (REU)||Standard Deviation|Mean
1354804|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Creatinine, and Bilirubin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||µmol/L||Inter-Quartile Range|Median
1354692|NCT01736696|Secondary|Number of Participants With Physician’s Global Assessment (PGA) of Psoriasis|Physician global assessment (PGA) of Psoriasis is a 7-point scale used to assess severity of psoriatic plaques, scaling and/or erythema. Severity scale ranged from 1 to 7: 1=severe, 2=moderate to severe, 3=moderate, 4=mild to moderate, 5=mild, 6=almost clear, 7=clear (no sign of psoriasis).|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||participants|||Number
1354693|NCT01736696|Secondary|Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14|Modified Psoriasis Area and Severity Index (mPASI) assessed lesion severity but not the body surface area affected. Severity was estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final mPASI = sum of the each component scores. Total score range 0-12 , higher score indicated more severity.|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||participants|||Number
1354694|NCT01736696|Primary|Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)|EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.|Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL|||Number
1354695|NCT01736696|Primary|Time to Reach Maximum Change From Baseline and Time to Return to Baseline Value for Fluorescence-Activated Cell Sorting (FACS), Reticulocyte Counts and Immune Cell Function||Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42|Data was not analyzed as per planned analyses due to pattern of changes observed.||||||
1354696|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 42|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
1354697|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 28|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
1354698|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 21|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
1354699|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 15|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 15|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
1354700|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 10|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
1354701|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 7|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
1354702|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 4|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
1354703|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 2|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 2|Analysis population included all participants who met the eligibility criteria. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.|||1000 cells/cubic millimeter (cells/mm^3)||Standard Deviation|Mean
1354704|NCT01736696|Primary|Change From Baseline in Immune Cell Function at Day 14|The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, >= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.|Baseline (Within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.|||ng/mL||Standard Deviation|Mean
1354797|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|9 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
1354705|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354706|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354707|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354708|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, Hour 0 on Day 18|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354709|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline; hr 0, 8 hr post-dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354710|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354711|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354712|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354713|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 2|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1354714|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, 1 hr post-dose on Day 1|Analysis population included all participants who met the eligibility criteria.|||percent change||Standard Deviation|Mean
1354715|NCT01736696|Primary|Accumulation Ratio (R0)|Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Ratio||Standard Deviation|Mean
1354716|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr||Full Range|Median
1354717|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr||Full Range|Median
1354718|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1354719|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1354720|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
1354721|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1354722|NCT01736696|Primary|Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum QTc >=500 msec were reported.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.|||participants|||Number
1354723|NCT01736696|Primary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.|||participants|||Number
1354798|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|6 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
1354724|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
1354725|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
1354726|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
1354727|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
1354728|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
1354729|NCT01736696|Primary|Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.|Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14|Analysis population included all participants who met the eligibility criteria.|||msec||Standard Deviation|Mean
1354730|NCT01736696|Primary|Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.|8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
1354731|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||msec||Standard Deviation|Mean
1354732|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||msec||Standard Deviation|Mean
1354799|NCT01736475|Secondary|Changes in Lipid Panel Assessments From Screening – Cholesterol; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Triglycerides; and Very Low Density Lipoprotein (VLDL)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||mmol/L||Inter-Quartile Range|Median
1354733|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||msec||Standard Deviation|Mean
1354734|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.|||msec||Standard Deviation|Mean
1354735|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.|||millisecond (msec)||Standard Deviation|Mean
1354736|NCT01736657|Secondary|Device-related Serious Adverse Events (SAE) in the Full Analysis Set|Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).|upon signing consent to 24 hours post-procedure|Seventy-three enrolled: 12 were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 patients), but these patients were included in safety analysis as Full Analysis Set; 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||participants|||Number
1354737|NCT01736657|Secondary|Spectra Optia System’s Ability to Achieve the Desired Final Hematocrit in the Evaluable Population|Measurement of the patient post-procedure hematocrit compared to the final target hematocrit calculated by the Spectra Optia Apheresis System. Final target hematocrit was calculated by tracking the number of red cells coming into the system versus the number of red cells removed.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||ratio||95% Confidence Interval|Mean
1354738|NCT01736657|Secondary|Procedural Success of the Spectra Optia System in the Evaluable Population|The procedural success of the Spectra Optia System is defined as the ability of the device to complete a red blood cell exchange (RBCx) and to obtain a satisfactory exchange by lowering the patient's hemoglobin S, as determined by the investigator in the evaluable population (60 pts).|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||percentage of participants|||Number
1354739|NCT01736657|Primary|Mean Ratio Actual Fraction of Cells Remaining (FCRa; as Measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp; as Predicted by the Spectra Optia System FCR Algorithm Multiplied by the Pre-Procedure % HbS)|The primary endpoint evaluated the mean ratio of the Actual Fraction of Cells Remaining (FCRa: as measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp: as predicted by the Spectra Optia system FCR algorithm multiplied by the Pre-Procedure % HbS), in the evaluable population (60 pts). The pre-defined range for the mean ratio of the FCRa to the FCRp was 0.75 to 1.25.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||ratio||95% Confidence Interval|Mean
1354740|NCT01736579|Secondary|Volumetric MRI|Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354741|NCT01736579|Secondary|Time to Skilled Nursing Facility Placement|Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354742|NCT01736579|Secondary|Caregiver Burden Questionnaire|The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354743|NCT01736579|Secondary|Healthcare Resource Utilization Questionnaire (HRUQ)|The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354744|NCT01736579|Secondary|EQ-5D Questionnaire (Proxy Version)|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.~The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0].~Caregivers are asked to describe how they believe a participant would rate his/her health state that day."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354745|NCT01736579|Secondary|Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)|The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant’s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354746|NCT01736579|Secondary|Neuropsychiatric Inventory (NPI) Score|The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354747|NCT01736579|Secondary|Mini Mental State Examination (MMSE)|The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354748|NCT01736579|Secondary|Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354749|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)|The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354750|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at the site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
1354751|NCT01736579|Primary|Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)||6 months||||infusions|Infusions||Number
1354752|NCT01736579|Primary|Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months||||infusions|Infusions||Number
1354753|NCT01736579|Primary|Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months||||infusions|Infusions||Number
1354754|NCT01736579|Primary|Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months||||adverse events|||Number
1354755|NCT01736553|Secondary|Correlation of Biomarkers (Weight) With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (14/14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of subjects with SMA and significant mortality.|||kg/scores on a scale||95% Confidence Interval|Mean
1354800|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Erythrocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||TI/L||Inter-Quartile Range|Median
1354756|NCT01736553|Secondary|Correlation of Protein Level Biomarkers With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (10/10) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, insufficient sample, subset of subjects with SMA and significant mortality.|||(pg/10^7 PBMC0/scores on a scale||95% Confidence Interval|Mean
1354757|NCT01736553|Secondary|Correlation of mRNA Biomarkers With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (14 and 14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of subjects with SMA and significant mortality.|||(SMN/HPRT)/scores on a scale||95% Confidence Interval|Mean
1354758|NCT01736553|Secondary|Correlation of CMAP Biomarker With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (14/14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of subjects with SMA and significant mortality.|||mV/scores on a scale||95% Confidence Interval|Mean
1354759|NCT01736553|Secondary|Putative Physiological Biomarkers-Weight SMN Copy Number =2 Cohort|Describe and compare the distribution of motor function assessments over the first two years of life in SMA subjects with SMN copy number = 2 versus healthy control infants|Up to 24 months|The overall number of participants analyzed (14 and 26) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment, subset of SMA subjects, and significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||kg||95% Confidence Interval|Mean
1354760|NCT01736553|Secondary|Molecular Biomarkers- SMN Protein Levels SMA Copy Number = 2|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA2 vs. healthy control infants.|Up to 24 months|Patients enrolled in the trial at birth. The overall number of participants analyzed (10 and 18) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment, significant mortality, subset of SMA subjects, and insufficient sample.|||pg/10^7 PBMC||95% Confidence Interval|Mean
1354761|NCT01736553|Secondary|Molecular Biomarkers- mRNA SMA Copy Number = 2 Cohort|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.|Up to 24 months|The overall number of participants analyzed (14 and 22) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, subset of patients with SMA, significant mortality, and insufficient sample.|||SMN/HPRT Ratio||95% Confidence Interval|Mean
1354762|NCT01736553|Secondary|Putative Physiological Biomarker- Compound Motor Action Potential Testing (CMAP) SMN Copy Number = 2 Cohort|"Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA2 vs. healthy control infants.~Maximum ulnar CMAP amplitude and area will be obtained by recording from the abductor digitiminimi muscle following ulnar nerve stimulation at the wrist. All electrophysiologic testing will be performed by certified electromyographers experienced in the assessment of pediatric patients. Maximum values for both negative peak (NP) amplitude and NP area will be obtained. No medications will be used.~This test is done routinely in this population. Pediatric electrodes and each site's standard electromyograph devices will be utilized. The test, while not considered to be painful, may cause some discomfort similar to a static electric shock. Infants may whimper or cry due to the surprise of the shock. Each shock lasts approximately 0.1 millisecond. The testing duration is expected to be approximately 30 seconds."|Up to 24 months|The overall number of participants analyzed (13 and 26) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, subset of patients with SMA, significant mortality, and tolerance of procedure.|||mV||95% Confidence Interval|Mean
1354763|NCT01736553|Secondary|Motor Function Assessments- The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disorders (CHOP-INTEND) SMN Copy Number =2 Cohort|"Describe and compare the distribution of motor function assessments over the first two years of life in SMA subjects with SMN copy number = 2 versus healthy control infants.~The CHOP-INTEND is a reliable and validated, comprehensive assessment of the postural and selective control of movement needed by infants. It is a clinician-rated questionnaire developed to assess motor skill in spinal muscular atrophy type I. The 16 items are scored from 0 to 4. The global score ranges from 0 to 64, a higher score indicating better motor skills.(Finkel, McDermott, 2014)."|Up to 24 months|The overall number of participants analyzed (14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of infants with SMN2 , and significant mortality. Healthy controls did not complete this visit due to the protocol.|||Scores on a scale||95% Confidence Interval|Mean
1354764|NCT01736553|Secondary|Motor Function Assessments- Test for Infant Motor Performance Screening Items (TIMPSI) SMN Copy Number =2 Cohort|"Describe and compare the distribution of motor function assessments over the first two years of life in SMA subjects with SMN copy number = 2 versus healthy control infants.~The TIMPSI is used to assess the postural and selective control of movement typically used by infants younger than 5 months. The TIMPSI scores were related to an infant's ability to reach. The TIMPSI is a 29-item evaluation that contains 3 item sets: a Screening set, an Easy set, and a Hard set. The Screening set consists of 11 items from the TIMP, each with a 5- to 7-point rating scale; the Easy set has 6 items with 5- or 6-point rating scales and 4 dichotomously scored items; the Hard set has 8 items, 3 with 5-point rating scales and 5 items that are scored dichotomously. The Total score is derived from all subset scores and is the sum of those subset scores. The final score could range from 0 to 99 points. The higher the score the better the functional ability of the participant."|Up to 24 months|The overall number of participants analyzed (14 and 26) differs from the total enrollment reported in the participant flow (26 and 27 respectively) because of the staggered enrollment, subset of infants with SMN2 & significant mortality.|||Scores on a scale||95% Confidence Interval|Mean
1354765|NCT01736553|Secondary|Biomarker Prediction of Risk of Death|Examine whether any of the motor function assessments, putative physiological, or molecular biomarkers predict risk of death in the SMA cohort. Proportional hazards regression models used to determine if motor function scores, mRNA, and protein levels predict death in SMA subjects. Considered each predictor separately modeled as a time-varying covariate (predictor values were allowed to vary as time to death was assessed).|Up to 24 months||||Hazard Ratio||95% Confidence Interval|Mean
1354766|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for Healthy Control Subjects- Weight|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and AIMS.|up to 24 months|The overall number of participants analyzed (26 and 26) differs from the total enrollment reported in the participant flow (27) because of the staggered enrollment and significant mortality.|||kg/scale unit||95% Confidence Interval|Mean
1354767|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for Healthy Control Subjects- mRNA|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and AIMS.|up to 24 months|Labs were not obtainable for all subjects. The overall number of participants analyzed (26 and 26) differs from the total enrollment reported in the participant flow (27) because of the staggered enrollment, significant mortality and protocol design.|||(SMN/HPRT Ratio)/scale unit||95% Confidence Interval|Mean
1354768|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for Healthy Control Subjects- CMAP|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and AIMS.|up to 24 months|The overall number of participants analyzed (26 and 26) differs from the total enrollment reported in the participant flow at each visit (27) because of the staggered enrollment, significant mortality and tolerance of testing.|||mV/scale unit||95% Confidence Interval|Mean
1354769|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- Weight|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND.|up to 24 months||||kg/scale unit||95% Confidence Interval|Mean
1354770|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- SMN Protein|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND. In the CHOP-INTEND analyses, the correlation at the 24 month visit was not estimable.|up to 24 months|The overall number of participants analyzed (14 and 19) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment and significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||(pg/10^7 PBMC)/scale unit||95% Confidence Interval|Mean
1354771|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- mRNA|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND.|up to 24 months||||(SMN/HPRT ratio)/scale unit||95% Confidence Interval|Mean
1354772|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- CMAP|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND. In the CHOP-INTEND analyses, correlations were not estimable for the 18 and 24 month visits.|up to 24 months|The overall number of participants analyzed (19 and 14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment and significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||mV/scale unit||95% Confidence Interval|Mean
1354773|NCT01736553|Primary|Putative Physiological Biomarkers-Weight|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.|Up to 24 months|Subjects enrolled from birth to 6 months. The overall number of participants analyzed (19 and 26) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment & significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||kg||95% Confidence Interval|Mean
1354774|NCT01736553|Primary|Molecular Biomarkers- SMN Protein Levels|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.|Up to 24 months|Patients enrolled in the trial from birth to 6 months. The overall number of participants analyzed (15 and 18) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment, significant mortality, insufficient sample. Therefore not all infants enrolled were included in all longitudinal analyses.|||pg/10^7 PBMC||95% Confidence Interval|Mean
1354775|NCT01736553|Primary|Molecular Biomarkers- mRNA|"Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.~Results were measured in survival motor neurons (SMN), hypoxanthine phosphoribosyltransferase (HPRT) Ratio."|Up to 24 months|Patients enrolled in the trial from birth to 6 months. The overall number of participants analyzed (19 and 22) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, significant mortality, & insufficient sample. Therefore not all infants enrolled were included in all longitudinal analyses.|||SMN/HPRT Ratio||95% Confidence Interval|Mean
1354776|NCT01736553|Primary|Putative Physiological Biomarker- Compound Motor Action Potential Testing (CMAP)|"Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.~Maximum ulnar CMAP amplitude and area will be obtained by recording from the abductor digitiminimi muscle following ulnar nerve stimulation at the wrist. All electrophysiologic testing will be performed by certified electromyographers experienced in the assessment of pediatric patients. Maximum values for both negative peak (NP) amplitude and NP area will be obtained. No medications will be used.~This test is done routinely in this population. Pediatric electrodes and each site's standard electromyograph devices will be utilized. The test, while not considered to be painful, may cause some discomfort similar to a static electric shock. Infants may whimper or cry due to the surprise of the shock. Each shock lasts approximately 0.1 millisecond. The testing duration is expected to be approximately 30 seconds."|Up to 24 months|Patients enrolled in the trial from birth to 6 months. The overall number of participants analyzed (18/ and 26) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, significant mortality and tolerance of procedure. Therefore not all infants enrolled were included in all longitudinal analyses.|||mV||95% Confidence Interval|Mean
1354777|NCT01736553|Primary|Motor Function Assessments-Alberta Infant Motor Scale (AIMS)|"Linear mixed effects models were used for analyses.~The reason that the number of infants differ from those in participant flow is based upon the protocol. The selection of which secondary test to perform depended upon the score of the TIMPSI that was performed. TIMPSI <41, do CHOP-NTEND. TIMPSI > 41, do AIMS.~The AIMS incorporates the neuromaturational concept and the dynamical systems theory and is used to measure gross motor maturation of infants from birth through the age of independent walking (Piper, Pinnell et al. 1992, Piper, Darrah et al 1994). In the AIMS, the impact of neurological components on motor development is reflected by a sequence of motor skills, which are used as the basis of assessment. The AIMS consists of 58 items, including 4 positions: prone (21 items), supine (9 items), sitting (12 items) & standing(16 items). The highest score available is 58. The higher the score the better the functional ability of the participant."|Up to 24 months|Patients enrolled in the trial from birth to 6 months of age. The overall number of participants analyzed (5 and 26) differs from the total enrollment in each cohort reported in the participant flow (26 and 27) because of the staggered enrollment, significant mortality and protocol design of who was eligible for this second motor measure.|||Scores on a scale||95% Confidence Interval|Mean
1354778|NCT01736553|Primary|Motor Function Assessments- The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disorders (CHOP-INTEND)|The TIMPSI motor function testing was done during all of the study visits knowing that the healthy controls would eventually ceiling out. The study design allowed for secondary motor function tests based on the score of the TIMPSI. If infants scored a 41 or above on the TIMPSI they would be tested with the AIMS. If they were below they were tested with the CHOP-INTEND. The CHOP-INTEND is a reliable and validated, comprehensive assessment of the postural and selective control of movement needed by infants. It is a clinician-rated questionnaire developed to assess motor skill in spinal muscular atrophy type I. The 16 items are scored from 0 to 4. The global score ranges from 0 to 64, a higher score indicating better motor skills.(Finkel, McDermott, 2014). All healthy controls based upon scores at 6 months moved on to the AIMS test, therefore no healthy controls completed the CHOP-INTEND. Linear mixed effects models were used for analyses of Motor function outcome data.|Up to 24 months|Patients enrolled in the trial from birth. The overall number of participants analyzed (14 and 0) differs from the total enrollment in each cohort reported in the participant flow (26 and 27, respectively) because of the staggered enrollment, significant mortality, and protocol design of who was eligible for this second motor measure.|||scores on a scale||95% Confidence Interval|Mean
1354779|NCT01736553|Primary|Motor Function Assessments- Test for Infant Motor Performance Screening Items (TIMPSI)|"Describe & compare the distribution of motor function assessments over the first two years of life in SMA vs. healthy control infants.~The TIMPSI is used to assess the postural and selective control of movement typically used by infants younger than 5 months. The TIMPSI scores were related to an infant's ability to reach. The TIMPSI is a 29-item evaluation that contains 3 item sets: a Screening set, an Easy set, and a Hard set. The Screening set consists of 11 items from the TIMP, each with a 5- to 7-point rating scale; the Easy set has 6 items with 5- or 6-point rating scales and 4 dichotomously scored items; the Hard set has 8 items, 3 with 5-point rating scales and 5 items that are scored dichotomously. The Total score is derived from all subset scores and is the sum of those subset scores. The final score could range from 0 to 99 points. The higher the score the better the functional ability of the participant. Linear mixed effects models were used for analyses."|Up to 24 months|The overall number of participants analyzed (19 and 26) differs from the total enrollment in each cohort reported in the participant flow (26 and 27, respectively) because of the staggered enrollment and significant mortality.|||scores on a scale||95% Confidence Interval|Mean
1354780|NCT01736540|Secondary|Investigator Treatment Decisions Based on MRI Results|"Treatment decisions were recorded after the investigator evaluated the MRI results, in order to assess the impact of such diagnostic test on the overall clinical management of participants with iron overload. Investigators answered the following question: Since the MRI scan, have you changed or are planning to change the management of iron in your subject?."|2 months|Participants, for whom treatment decision questionnaire results were provided and for whom MRI results were available, were included in the analysis.|||Percentage of participants|||Number
1354781|NCT01736540|Secondary|Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy|"Adherence of participants was assessed using an adherence questionnaire. Adherence questionnaires were completed only by participants who received chelating agents. Participants answered yes or no to 6 statements such as Forgot to take pills. Based on the responses to these questions, adherence was classified as low, medium or high."|1 month|Participants who were on iron chelator therapy at screening, and had answered at least one question on the questionnaire and had sufficient information to score the questionnaire, were included in the analysis.|||Percentage of participants|||Number
1354801|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening – Hemoglobin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||g/L||Inter-Quartile Range|Median
1355073|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Deviation|Mean
1354782|NCT01736540|Secondary|Mean Quality of Life (QOL) Scores|Quality of life was assessed using the Short Form 36 (SF-36) Health Survey. The SF-36 consists of 8 sub-scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The raw sores of the 8 scales are transformed to a 0 - 100 scale where 0 indicates maximum disability and 100 indicates no disability. There also are two physical and mental health summary measures. Each summary measure is the mean average of the 4 associated sub-scale scores. The range for each summary measure is 0 to 100 where 0 represents maximum disability and 100 represents no disability.|1 month|Only participants with data for each subscale were included in the analysis for that subscale.|||units on a scale||Standard Deviation|Mean
1354783|NCT01736540|Secondary|Mean Number of Erythrocyte Units Transfused in Last 12 Months|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with 'number of units transfused' data were included in the analysis.|||number of units transfused||Standard Deviation|Mean
1354784|NCT01736540|Secondary|Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with data on time since their most recent transfusion were included in the analysis.|||percentage of participants|||Number
1354785|NCT01736540|Secondary|Percentage of Participants Transfused With Erythrocytes|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with a erythrocyte transfusion history were included in the analysis.|||Percentage of participants|||Number
1354786|NCT01736540|Secondary|Mean Blood Magnetic Susceptibility (BMS)|Blood samples were collected to assess BMS. The measurement represents absolute magnetic susceptibility at 1 month. Whole blood magnetic susceptibility was calculated by the addition of the dry weight susceptibility and the contribution of the water driven from the sample.|1 month|Participants with BMS values were analyzed.|||emu/g wet wt/Oe||Standard Deviation|Mean
1354787|NCT01736540|Secondary|Mean LIC According to the Presence or Absence of Retrospective Hepatic Events|Mean LIC according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with LIC by MRI were included in the analysis.|||mg Fe/g||Standard Deviation|Mean
1354788|NCT01736540|Secondary|Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events|Mean cardiac T2* according to the presence or absence of cardiac events was assessed for all participant subgroups. The mean data presented are mean estimates of log transformed data.|12 months - retrospective|Participants with valid T2* by MRI results were included in the analysis.|||log10 (ms)||Standard Deviation|Mean
1354789|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events|Mean serum ferritin according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous hepatic events data were included in the analysis.|||ng/mL||Standard Deviation|Mean
1354790|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events|Mean serum ferritin according to the presence or absence of cardiac events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous cardiac events data were included in the analysis.|||ng/mL||Standard Deviation|Mean
1354791|NCT01736540|Secondary|Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). The mean data presented are mean estimates of log transformed data.|2 months|Only participants with valid LIC by MRI were included in the analysis.|||mg Fe/g||95% Confidence Interval|Mean
1354792|NCT01736540|Secondary|Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups).|2 months|Only participants with valid T2* by MRI were included in the analysis.|||ms||95% Confidence Interval|Least Squares Mean
1354793|NCT01736540|Primary|Cardiac Siderosis Severity|Cardiac siderosis severity was measured by MRI (T2*). The severity grade of siderosis was tiered in 3 levels: mild (T2* >= 20ms), moderate (T2* from 10 to 20ms), and severe (T2* <10ms). Mild cardiac siderosis, by the definitions used in this study, were equivalent to not having cardiac siderosis. Values were compared to published thresholds of iron overload to determine severity of transfusion siderosis in the participant population studied.|2 months|Only participants with valid T2* by MRI were included in the analysis.|||Percentage of participants|||Number
1354794|NCT01736540|Primary|Percentage of Participants With Cardiac and Liver Iron Overload.|Hepatic iron overload (liver siderosis) and cardiac iron overload (cardiac siderosis) in patients with transfusional siderosis (Myelodysplastic syndrome (MDS), thalassaemia major, non-transfusion-dependent thalassaemia (NTDT) and other anaemias) were measured using MRI (R2 by FerriScan and T2*, respectively).|2 months|Only participants with valid T2* by MRI and valid liver iron concentration (LIC) by MRI were included for the cardiac siderosis and liver siderosis analyses, respectively.|||Percentage of participants|||Number
1354795|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|24 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
1354796|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|12 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
1354967|NCT01734785|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)|||mmol/L||Standard Error|Least Squares Mean
1354805|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Bicarbonate, Chloride, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||mmol/L||Inter-Quartile Range|Median
1354806|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase|Alkaline Phosphatase (Alk Phos); Alanine Aminotransferase (Ala Amino); Aspartate Aminotransferase (Asp Amino)|Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||Units per Liter||Inter-Quartile Range|Median
1354807|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Albumin and Protein||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||g/L||Inter-Quartile Range|Median
1354808|NCT01736475|Secondary|Changes in Vital Signs From Screening - Blood Pressure|Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP)|Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||mmHg||Inter-Quartile Range|Median
1354809|NCT01736475|Secondary|Change in Vital Signs From Screening - Respiratory Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||breaths per minute||Inter-Quartile Range|Median
1354810|NCT01736475|Secondary|Change in Vital Signs From Screening - Pulse Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||beats per minute||Inter-Quartile Range|Median
1354811|NCT01736475|Secondary|Change in Vital Signs From Screening - Temperature||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||Celsius||Inter-Quartile Range|Median
1354812|NCT01736475|Secondary|Pharmacokinetics (Pk) -Time to Maximum Concentration in Plasma (Tmax) (One-stage Clotting Assay)|Tmax in hours will be defined as the time to reach Cmax. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||hours||Standard Deviation|Mean
1354813|NCT01736475|Secondary|Pharmacokinetics (Pk) - Maximum Plasma Concentration (Cmax) (One-stage Clotting Assay)|Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||IU/dL||Standard Deviation|Mean
1354814|NCT01736475|Secondary|Pharmacokinetics (Pk) - Apparent Volume of Distribution at Steady State (Vss) (One-stage Clotting Assay)|"The apparent volume of distribution at steady state (Vss) will be calculated as: Vss = Clearance * Mean Residence Time.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||dL/kg||Standard Deviation|Mean
1354815|NCT01736475|Secondary|Pharmacokinetics (Pk) - Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC0-∞) (One-stage Clotting Assay)|"Calculated by WinNonlin NCA (Model 201, calculation method: Linear Trapezoidal Linear/Log Interpolation).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||(IU*hours)/dL||Standard Deviation|Mean
1354816|NCT01736475|Secondary|Pharmacokinetics (Pk) - Incremental Recovery Over Time (One-stage Clotting Assay)|"Incremental recovery (IR) in (IU/dL)/ (IU/kg) calculated as: IR = (Cmax– (C pre-infusion)) / (Dose/kg), where C =concentration.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1354817|NCT01736475|Secondary|Pharmacokinetics (Pk) - Total Body Clearance (One-stage Clotting Assay)|"Clearance in dL/(kg.h) will be calculated as the dose in IU/kg divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||dL/(kg*hours)||Standard Deviation|Mean
1354818|NCT01736475|Secondary|Pharmacokinetics (Pk) - Mean Residence Time (One-stage Clotting Assay)|"The mean residence time (MRT) w as calculated as total area under the moment curve divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||hours||Standard Deviation|Mean
1354819|NCT01736475|Secondary|Pharmacokinetics (Pk) - Plasma Half-life (One-stage Clotting Assay)|"Terminal half-life calculated as log_e2/λz where λz is the terminal elimination rate constant.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||hours||Standard Deviation|Mean
1354820|NCT01736475|Secondary|Patient Reported Outcomes - Short Form (SF)-36, Change From Baseline to End of Study|Change from Baseline to End of Study for SF-36 Questionnaire is provided. Scores for individual SF-36 categories range from 0 to 100 with higher scores representing better health. Given that higher scores indicate better health-related quality of life (HRQoL) and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates a worsening of HRQoL.|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm]|Full Analysis Set - Subset of participants with both baseline and study completion SF-36 scores|||Score on a scale||Standard Deviation|Mean
1354821|NCT01736475|Secondary|Patient Reported Outcomes: Haemo-SYM Questionnaire, Change in Score From Baseline to End of Study|"The HAEMO-SYM has two subscales: pain and bleeds. HAEMO-SYM subscale scores are calculated by taking the mean of the items in each subscale and transforming them to a 0 (none or absent) to 100 (very severe) scale.~Given that higher scores indicate more severe symptoms on the Haemo-SYM and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates an improvement (reduction in symptoms). Conversely, a positive change score indicates worsening symptoms."|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm].|Full Analysis Set - Subset of participants with both baseline and study completion HAEMO-SYM scores|||Score on a scale||Standard Deviation|Mean
1354822|NCT01736475|Secondary|Immunogenicity - Number of Participants With Positive Inhibitory Antibodies to FVIII, Binding Antibodies to FVIII, PEG-VIII, PEG and Anti-CHO Antibodies at Study Completion/Termination|"Number of participants who received BAX855, with immunogenicity data from study completion/termination visit.~FVIII = factor VIII; PEG-VIII = polyethylene glycol-factor VIII; Anti-CHO = Anti-Chinese hamster ovary"|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm but did not receive BAX855 (only received ADVATE, during the screening period).|||Participants|||Number
1354823|NCT01736475|Secondary|Percentage of Participants With Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - All participants treated with BAX 855 were analyzed as a single group (ie on-demand and prophylaxis treatment regimens were analyzed as a single group).|||percent of participants|||Number
1354824|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Treatment of Bleeding Episode (BE) and Per BE for Maintenance of Hemostasis|Infusions per bleeding episode for maintenance of hemostasis only includes infusions following the resolution of a bleed to maintain hemostasis.|Treatment of Bleeding Episode (BE): Minor/Moderate BE every 12 to 24 hours until bleeding is resolved; Major BE every 8 to 12 hours until bleeding is resolved. Per BE for Maintenance of Hemostasis: within 48 hours after bleeding episode resolution.|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 for treatment of BEs (2) BAX855 for Maintenance of Hemostasis.~Subset of participants who received BAX855 for treatment of BEs: N= 92~Subset BAX855 for Maintenance of Hemostasis participants: N=16"|||IU/kg|Bleeds|Standard Deviation|Mean
1354825|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Prophylactic Infusion and Pharmacokinetic (PK) Infusion||Prophylactic Infusion: ≥50 exposure days or 6 months (±2 weeks), whichever occurs last. PK Infusion: PK #1 Pre-infusion within 30 minutes; Post-infusion 10 min, and 0.5, 1, 3, 6, 24, 32, 48, 56 hours (h). PK #2 also at Post-infusion 96h|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 prophylactic infusion or (2) BAX855 pharmacokinetic (PK) participants.~Subset of participants who received BAX855 prophylactic infusion: N= 120~Subset of BAX855 pharmacokinetic (PK) participants: N=26"|||IU/kg|Infusions|Standard Deviation|Mean
1354826|NCT01736475|Secondary|Number of Participants With ≤1, 2, 3, 4, 5, 6, or >6 Month Time Intervals Between Bleeding Episodes or no Bleeding Episodes|Interval between Bleeds in months was calculated as: Observation period for efficacy (in days)/(number of bleeds)*(12/365.2425)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Study participants from the Full Analysis Set (FAS) who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm (thus was included in the FAS) and received only ADVATE during the screening period.|||Participants|||Number
1355066|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||percentage of blood volume||Standard Deviation|Mean
1354827|NCT01736475|Secondary|Average Number of BAX 855 Infusions Needed for the Treatment of Bleeding Episodes||From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Participants from the Full Analysis Set who experienced at least one bleeding episode.|||Infusions||Standard Deviation|Mean
1354828|NCT01736475|Secondary|Rate of Success of BAX 855 for Treatment of Bleeding Episodes|Success in the control of bleeding was defined as a rating of excellent or good using the Efficacy Rating Scale for Treatment of Bleeding Episodes measured 24 hours after initiation of treatment for the bleeding episode. EXCELLENT: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusions to maintain hemostasis would not affect this scoring. GOOD: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. FAIR: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution. NONE: No improvement or condition worsens.|At least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm.|Full Analysis Set - All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens were analyzed as a single group.|||Bleeding episodes|Bleeding episodes|95% Confidence Interval|Number
1354829|NCT01736475|Primary|Annualized Bleeding Rate (ABR)|Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.|9 months|Full Analysis Set|||Bleeds per year||95% Confidence Interval|Least Squares Mean
1354830|NCT01736397|Secondary|Change in Hemoglobin Levels From Baseline to End of Treatment|The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.|||g/dL||Standard Deviation|Mean
1354831|NCT01736397|Secondary|Change in Ferritin Levels From Baseline to End of Treatment|The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.|||ng/mL||Standard Deviation|Mean
1354832|NCT01736397|Primary|Change in Serum Phosphorus Levels From Baseline to End of Treatment|The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.|||mg/dL||Standard Deviation|Mean
1354833|NCT01736397|Primary|Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment|The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|Efficacy analyses were based on Intent-to-Treat (ITT) population, which consisted of all randomized subjects who had a baseline laboratory value, had taken at least 1 dose of study drug, & had at least 1 post-baseline laboratory value. ANCOVA with Last observation carried forward (LOCF) methodology was used.|||% saturation||Standard Deviation|Mean
1354834|NCT01736241|Secondary|Number of Participants Who Developed Anti-LY3053102 Antibodies|LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.|Baseline, up to Day 31|Participants who received at least one dose of LY3053102 or placebo and with evaluable anti-drug (LY3053102) ADA data.|||participants|||Number
1354835|NCT01736241|Secondary|PK: Observed Maximum Drug Concentration (Cmax) of LY3053102|Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.|Time 0 to 168 hours after study drug administration on Day 1|Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.|||microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1354836|NCT01736241|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102|AUC curve from time 0 to 168 hours postdose of LY3053102.|Time 0 to 168 hours after study drug administration on Day 1|Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.|||microgram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
1354837|NCT01736241|Primary|Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs|A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 31|Participants who received at least one dose of LY3053102 or placebo.|||participants|||Number
1354838|NCT01736215|Secondary|Transferring Iron Binding Capacity (TIBC)|TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Mcg per dl||Standard Deviation|Mean
1354839|NCT01736215|Secondary|Serum Iron Level|Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluated for this outcome measure.|||Microgram per deciliter (Mcg per dl)||Standard Deviation|Mean
1355067|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||percentage of blood volume||Standard Error|Mean
1354840|NCT01736215|Secondary|Serum Ferritin Level|Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Microgram per liter||Standard Deviation|Mean
1354841|NCT01736215|Secondary|Reticulocyte Count|Reticulocytes are immature red blood cells.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluablated for this outcome measure and 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Nanogram per liter||Standard Deviation|Mean
1354842|NCT01736215|Secondary|Serum Hematocrit Level|Hematocrit is the amount of red blood cells in the blood.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Percentage of red blood cells||Standard Deviation|Mean
1354843|NCT01736215|Secondary|Serum Hemoglobin Level|Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Gram per deciliter (g per dl)||Standard Deviation|Mean
1354844|NCT01736215|Secondary|Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4|CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.|||Participants|||Number
1354845|NCT01736215|Secondary|Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)|EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.|||Participants|||Number
1354846|NCT01736215|Primary|Percentage of Participants With Response to Erythropoietin Treatment|Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.|8 weeks|Participants who received erythropoietin treatment and had the data available at least on Baseline and at the end of study evaluation period.|||Percentage of participants|||Number
1354847|NCT01736176|Secondary|Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60|"Letter fluency was assessed using a paper and pen test, in which participants were asked to generate as many words as possible in 60 seconds, starting with the letters F, A, or S.~The COWAT All Letters score is the number of words recalled in all post-baseline assessments, regardless of letter used.~The COWAT Baseline Letter score is the number of words recalled in post-baseline assessments that used the same letter as at Baseline."|Baseline and Week 60|Efficacy dataset with available data|||words||Standard Deviation|Mean
1354848|NCT01736176|Secondary|Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data|||units on a scale||Standard Deviation|Mean
1354849|NCT01736176|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The between errors score is the number of times the participant revisited a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data|||errors||Standard Deviation|Mean
1354850|NCT01736176|Secondary|Change From Baseline in Health-related Productivity|"The Health-Related Productivity Questionnaire (HRPQ) is a generic measure of the impact of disease on the ability of the participant to be productive at paid employment or at performance of household chores. Questions inquire about the amount of time they were scheduled/planned to work, the number of the scheduled/planned hours they were able to work and their ability to be productive for the hours of work they did perform.~Absenteeism: Number of hours not worked due to PD or it's treatments;~Presenteeism: Number of hours of lost productivity while at work due to PD or it's treatments;~Total hours lost: Number of hours lost due to absenteeism and presenteeism"|Baseline, Week 12 and Week 60|Efficacy dataset with available data. Workplace hours lost is calculated for participants who were employed.|||hours||Standard Deviation|Mean
1354851|NCT01736176|Secondary|Treatment Satisfaction Questionnaire Scores|The Treatment Satisfaction Questionnaire (TSQ) is a single item instrument developed by the Sponsor on which the participant indicated their level of satisfaction or dissatisfaction with their PD treatment. The responses are recorded on a Likert-type scale (Very Satisfied, Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied).|Week 12 and Week 60|Efficacy dataset|||Participants|||Count of Participants
1354852|NCT01736176|Secondary|Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved|"The PGIC is a 7-point response scale. Participants were asked to rate their change in status using the following 7-point scale:~1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.~The responses of Very much improved, Much improved and Minimally improved on the PGIC were used to define responders."|Week 12 and Week 60|Efficacy dataset|||percentage of participants|||Number
1354853|NCT01736176|Secondary|Change From Baseline in PDQ-39 Bodily Discomfort Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354854|NCT01736176|Secondary|Change From Baseline in PDQ-39 Communication Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354855|NCT01736176|Secondary|Change From Baseline in PDQ-39 Cognition Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354856|NCT01736176|Secondary|Change From Baseline in PDQ-39 Social Support Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354857|NCT01736176|Secondary|Change From Baseline in PDQ-39 Stigma Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354858|NCT01736176|Secondary|Change From Baseline in PDQ-39 Emotional Well-Being Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354886|NCT01735916|Secondary|Quality of Life (QoL)|"The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures.~Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.~Two QOL questionnaires were used in the study.~EQ-5D: scores typically range from 0-1, where higher scores reflect better quality of life KCCQ: scores range from 0-100, where higher scores reflect better quality of life"|Assessed from baseline visit to 24-month follow-up visit|||||||
1354859|NCT01736176|Secondary|Change From Baseline in PDQ-39 Activities of Daily Living Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354860|NCT01736176|Secondary|Change From Baseline in PDQ-39 Mobility Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354861|NCT01736176|Secondary|Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 – 100 scale where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354862|NCT01736176|Secondary|Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The modified Hoehn and Yahr scale is as follows:~Stage 0: No signs of disease~Stage 1.0: Symptoms are very mild; unilateral involvement only~Stage 1.5: Unilateral and axial involvement~Stage 2: Bilateral involvement without impairment of balance~Stage 2.5: Mild bilateral disease with recovery on pull test~Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent~Stage 4: Severe disability; still able to walk or stand unassisted~Stage 5: Wheelchair bound or bedridden unless aided"|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354863|NCT01736176|Secondary|Change From Baseline in UPDRS Dyskinesia Items Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The dyskinesia items score includes questions 32, 33 and 34 from the complications of therapy section of the UPDRS which address dyskinesia duration, disability, and pain. Each question was answered on a scale from 0 (Normal) to 4 (Severe); the UPDRS dyskinesia items score was computed as the sum of these items and ranged from 0 (not affected) to 12 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354864|NCT01736176|Secondary|Change From Baseline in UPDRS Part IV: Complications of Therapy Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The complications of therapy section includes 11 items addressing dyskinesia duration, disability, and pain, early morning dystonia, “offs”-predictable, “offs”-unpredictable, “offs”-sudden, “offs”-duration, anorexia-nausea-vomiting, sleep disturbance, and symptomatic orthostasis. Four questions are answered on a scale from 0 (Normal) to 4 (Severe) and seven on a binary scale where 0=No and 1=Yes. The UPDRS Part IV: complications of therapy score was computed as the sum of these items and ranged from 0 (not affected) to 23 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354887|NCT01735916|Secondary|Recurrent HF Events|"The frequency of HF events between the study groups~Note: No endpoints were reached, so this objective was not analyzed~- HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months|||||||
1354924|NCT01735214|Secondary|Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale|The physician evaluated the patient’s tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with data available for analysis.|||percentage of participants|||Number
1354865|NCT01736176|Secondary|Change From Baseline in UPDRS Part III: Motor Examination Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The motor examination score includes 17 items addressing speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. Each question is answered on a scale from 0 (Normal) to 4 (Severe), some items include multiple grades for each extremity. The UPDRS Part III: motor examination score was computed as the sum of these items and ranged from 0 (not affected) to 108 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point|||units on a scale||Standard Error|Least Squares Mean
1354866|NCT01736176|Secondary|Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The activities of daily living score includes 13 items addressing speech, salivation, swallowing, handwriting, cutting food, dressing, hygiene, turning in bed, falling, freezing, walking, tremor, and sensory complaints. Each question is answered on a scale from 0 (Normal) to 4 (Severe). The UPDRS Part II: activities of daily living score was computed as the sum of these items and ranged from 0 (not affected) to 52 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point|||units on a scale||Standard Error|Least Squares Mean
1354867|NCT01736176|Secondary|Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The mentation, behavior, and mood score includes 4 items addressing intellectual impairment, thought disorder, motivation/initiative, and depression. Each question is answered on a scale from 0 (None) to 4 (Severe). The UPDRS Part I: mentation, behavior, and mood score was computed as the sum of these items and ranged from 0 (not affected) to 16 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point|||units on a scale||Standard Error|Least Squares Mean
1354868|NCT01736176|Secondary|Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I – Mentation, Behavior, and Mood~Part II – Activities of Daily Living~Part III – Motor Examination~Part IV – Complications of Therapy (including dyskinesias)~Part V – Modified Hoehn and Yahr Staging~The Total UPDRS score includes 31 items contributing to three subscales: (I) Mentation, Behavior, and Mood; (II) Activities of Daily Living; and (III) Motor Examination. Each question is answered on a scale from 0 (None) to 4 (Severe); Some questions require multiple grades assigned to each extremity. The UPDRS Total score was computed as the sum of these 3 UPDRS subscales and ranged from 0 to 176, with 176 representing the worst (total) disability, and 0 no disability."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point|||units on a scale||Standard Error|Least Squares Mean
1354869|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized On Time Without Troublesome Dyskinesia Based on PD Diary"|"The PD Diary was completed by the participant for 3 consecutive days prior to each visit. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from sleep.~On was defined as time when medication was providing benefit with regard to mobility, slowness, and stiffness. On time without troublesome dyskinesia is a composite of On time without dyskinesia (involuntary twisting, turning movements which are an effect of medication) plus On time with non-troublesome dyskinesia (dyskinesia that does not interfere with function or cause meaningful discomfort).~PD Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||hours||Standard Error|Least Squares Mean
1354870|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized Off Time Based on Parkinson's Disease Diary"|"The Parkinson's Disease Diary was completed by the participant for 3 consecutive days prior to each visit for the full 24 hours of each day. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from time asleep.~Off time was defined as time when medication has worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness.~Parkinson's Disease Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||hours||Standard Error|Least Squares Mean
1354899|NCT01735630|Secondary|Change From Baseline in NPI Total Scores|The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144.|Week 12|mITT population with available data for NPI Total Scores|||units on a scale||Standard Error|Mean
1354871|NCT01736176|Secondary|Change From Baseline in NMSS Miscellaneous Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354872|NCT01736176|Secondary|Change From Baseline in NMSS Sexual Function Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354873|NCT01736176|Secondary|Change From Baseline in NMSS Urinary Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354874|NCT01736176|Secondary|Change From Baseline in NMSS Gastrointestinal Tract Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354875|NCT01736176|Secondary|Change From Baseline in NMSS Attention/Memory Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354876|NCT01736176|Secondary|Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354877|NCT01736176|Secondary|Change From Baseline in NMSS Mood/Cognition Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354921|NCT01735214|Secondary|Physician Assessment of Adherence to New Treatment Using a 4-Point Scale|The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.|12 Weeks|All Participants|||percentage of participants|||Number
1354922|NCT01735214|Secondary|Percentage of Participants Who Continue the New Treatment After 12 Weeks||12 Weeks|All participants|||percentage of participants|||Number
1354878|NCT01736176|Secondary|Change From Baseline in NMSS Sleep/Fatigue Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
1354879|NCT01736176|Secondary|Change From Baseline in NMSS Cardiovascular Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS cardiovascular including falls domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time points|||units on a scale||Standard Error|Least Squares Mean
1354880|NCT01736176|Secondary|Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 60|Efficacy dataset with available data at baseline and week 60|||units on a scale||Standard Error|Least Squares Mean
1354881|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources Through Week 60|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The standard version of the questionnaire addressed the following questions over the last 3 months:~Has the subject had a visit to an emergency room?~Has the subject had an outpatient visit to any of the following healthcare providers?~Has the subject been visited in his or her place of residence by a health care professional?~Has the subject received assistance from either of the following for their Parkinson's disease in their home?~Has the subject needed to contact either of the following for immediate assistance related to their Parkinson's disease?~Have family members or friends had to miss any paid work due to the subject's Parkinson's disease?~Has the subject fallen during the past month?"|Week 60|Safety dataset with available data|||Participants|||Count of Participants
1354882|NCT01736176|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) related to treatment are those the investigator determined as having a reasonable possibility being related to study drug based on evidence to suggest a causal relationship between the study drug and the adverse event.~A severe AE was defined as an adverse event that caused considerable interference with the participant's usual activities and might be incapacitating or life-threatening.~Serious AEs were defined as those that were life-threatening or resulted in death, hospitalization or prolongation of hospitalization, a congenital anomaly, persistent or significant disability/incapacity, or important medical events requiring medical or surgical intervention to prevent a serious outcome."|Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days)|The Safety dataset|||Participants|||Count of Participants
1354883|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources During the First 4 Weeks|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The Week 4 version of the questionnaire addressed the following questions during the first four weeks after the PEG-J procedure:~Has the subject had a visit to an emergency room?~Has the subject had a visit to an urgent care?~Has the subject had an outpatient visit to a neurologist?~Has the subject had an outpatient visit to a gastroenterologist, surgeon, or interventional radiologist?~Has the subject had an outpatient visit to a primary care physician?~Has the subject called the nursing support line?~Has the subject called a physician?"|Weeks 1-4|The Safety dataset included all participants who underwent the PEG-J placement procedure|||Participants|||Count of Participants
1354884|NCT01736176|Primary|Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12|The Efficacy dataset included all participants who received at least 1 infusion of LCIG study drug and had a baseline and LCIG Treatment Period observation for at least one efficacy or health outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1354885|NCT01735916|Secondary|Reverse Remodeling by Echocardiography|"The change in LVEF between study groups.~Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed."|Assessed from baseline visit to 24-month follow-up visit|||||||
1354888|NCT01735916|Secondary|Mortality or Heart Failure Morbidity or Worsening Systolic Function|"Secondary Composite Efficacy Endpoint: The time to first event, with event defined as:~All-cause mortality~HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay, or~Worsening systolic function meeting an ICD/CRT-D indication, defined as:~A drop in LVEF to 35% or below, with an absolute decrease of greater than or equal to 10%, after maximum tolerated doses of guideline HF medications have been established~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months|||||||
1354889|NCT01735916|Secondary|Mortality|"Time to death between the study groups~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of death, for a minimum of 24 months and up to 60 months|||||||
1354890|NCT01735916|Primary|System-related Complication|"Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant.~Note: Because of the small number of subjects, number of complications was noted between arms and a time to event analysis was not performed.~Complication is defined as: An adverse event that results in death, involves any termination of significant device function, or requires an invasive intervention"|From the date of implant to the date of 6 month follow-up visit||||Complications|||Number
1354891|NCT01735916|Primary|Mortality or Heart Failure Morbidity|"Primary Efficacy Endpoint: The time to first event, with event defined as:~All-cause mortality, or~HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months|||||||
1354892|NCT01735877|Secondary|Modified Rankin Scale (mRS)|"0 - No symptoms at all / 1 - No significant disability despite symptoms / 2 - Slight disability / 3 -Moderate disability, but able to walk without assistance / 4 - Moderate disability and unable to walk without assistance / 5 - Severe disability / 6 – death~0-2: Good outcome 3-6: Poor outcome"|Baseline, 1,3 and 6 months||||participants|||Number
1354893|NCT01735877|Primary|Change From Baseline in Picture Identification Task at 1,3, and 6 Months|PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||pictures||95% Confidence Interval|Mean
1354894|NCT01735877|Primary|Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months|"The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to ﬁnd and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign.~We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months.~The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months."|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||cms||95% Confidence Interval|Mean
1354895|NCT01735877|Secondary|Functional Independence Measure|"The FIM consists of 13 motor and 5 social-cognitive items, assessing self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.14 It uses a 7-level scale anchored by extreme rating of total dependence as 1 and complete independence as 7; the intermediate levels are: 6 modiﬁed independence, 5 supervision or set-up, 4 minimal contact assistance, 3 moderate assistance and 2 maximal assistance.~For the purpose of analysis we divided FIM into two categories ≤5 dependent, ≥6 independent."|Baseline, 1, 3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||participants|||Number
1354896|NCT01735877|Primary|Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months|"The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT.~Minimum score: 0 Maximum score: 54~Higher scores: better outcome"|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||units on a scale||95% Confidence Interval|Mean
1354897|NCT01735630|Secondary|Change From Baseline in ADCS-ADL Scores|The Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for ADCS-ADL Scores|||units on a scale||Standard Error|Mean
1354898|NCT01735630|Secondary|Change From Baseline in MMSE Scores|The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for MMSE Scores|||units on a scale||Standard Error|Mean
1354923|NCT01735214|Secondary|Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks||12 Weeks|All participants.|||percentage of participants|||Number
1354900|NCT01735630|Secondary|Change From Baseline in Modified-ADCS-CGIC Agitation Scores|The Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation.|Week 12|mITT population with available data for Modified-ADCS-CGIC Agitation Scores|||units on a scale||Standard Error|Mean
1354901|NCT01735630|Primary|Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).|The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.|Week 12|mITT|||units on a scale||Standard Error|Mean
1354902|NCT01735617|Secondary|AUC Values (Pmol*h/L) for ACTH|AUC values (pmol*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)||||pmol*h/L||Standard Deviation|Mean
1354903|NCT01735617|Secondary|AUC Values (Nmol*h/L) for 17-OHP|AUC values (nmol*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)||||nmol*h/L||Standard Deviation|Mean
1354904|NCT01735617|Secondary|AUC Values (Nmol*h/L) for Androstenedione|AUC values (nmol*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)||||nmol*h/L||Standard Deviation|Mean
1354905|NCT01735617|Secondary|ACTH Levels at 0700h, 1700h and 2300h|ACTH levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)||||pmol/L||Standard Deviation|Mean
1354906|NCT01735617|Secondary|Androstenedione Levels at 0700h, 1700h and 2300h|Androstenedione levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)||||nmol/L||Standard Deviation|Mean
1354907|NCT01735617|Secondary|17-OHP Levels at 0700h, 1700h and 2300h|17-OHP levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)||||nmol/L||Standard Deviation|Mean
1354908|NCT01735617|Secondary|The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)|Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females|Specific time point (0700hrs)||||percentage of participants|||Number
1354909|NCT01735617|Primary|Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|Time to maximum plasma concentration (tmax)|24 hours|All treated subjects|||Hours||Standard Deviation|Mean
1354910|NCT01735617|Primary|Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)|24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)|All treated subjects|||h*nmol/L||Standard Deviation|Mean
1354911|NCT01735617|Primary|Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|The maximum plasma concentration (Cmax) of chronocort|24 hours|All treated subjects|||nmol/L||Standard Deviation|Mean
1354912|NCT01735396|Secondary|Testosterone|Post-treatment changes in testosterone|up to 12 weeks|data not collected||||||
1354913|NCT01735396|Secondary|Safety of Abiraterone|To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5|up to 12 weeks||||Participants|||Count of Participants
1354914|NCT01735396|Secondary|Bone Scan|"post-treatment changes in bone scans (as per PCWG2 guidelines) (no new lesions versus new lesions.)"|up to 12 weeks|data not collected||||||
1354915|NCT01735396|Secondary|Time to Progression|post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)|up to 12 weeks|data not collected||||||
1354916|NCT01735396|Secondary|Response Assessment|Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|up to 12 weeks||||Participants|||Count of Participants
1354917|NCT01735396|Primary|Number of Participants With ≥ 30% Change in PSA|The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.|baseline and 12 weeks||||Participants|||Count of Participants
1354918|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Left Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.|||mmHg||Standard Deviation|Mean
1354919|NCT01735214|Secondary|Percentage of Participants Reaching Individual IOP Target After 12 Weeks||12 Weeks|All participants|||percentage of participants|||Number
1354920|NCT01735214|Secondary|Physician Assessment of Efficacy Using a 5-Point Scale|The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.|12 Weeks|All participants.|||percentage of participants|||Number
1354925|NCT01735214|Secondary|Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale|The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with available data.|||percentage of participants|||Number
1354926|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Right Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.|||mmHg||Standard Deviation|Mean
1354927|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 1|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of participants|||Number
1354928|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 0.5|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of participants|||Number
1354929|NCT01735201|Primary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hours 2 to 12|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of participants|||Number
1354930|NCT01735175|Secondary|Mortality Due to Infection|Number of patients with death due to infections|Study course (41 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
1354931|NCT01735175|Secondary|Frequency of Infections by Cycle and Across All Cycles|The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class “Infections and Infestations”.|across all cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
1354932|NCT01735175|Secondary|Time to ANC Recovery in Days in Cycle 1|Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient’s ANC had increased to ≥ 2 × 10^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10^9 cells/L are given.|across Cycle 1 (3 weeks)|FAS set = full analysis set|||days||Standard Deviation|Mean
1354933|NCT01735175|Secondary|Number of Patients With ANC Nadir Per Day in Cycle 1|Numbers of patients with ANC nadir based per day during Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
1354934|NCT01735175|Secondary|Depth of ANC Nadir in Cycle 1|The depth of ANC nadir was defined as the patient’s lowest ANC (10^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set|||10^9 cells/L||Standard Deviation|Mean
1354935|NCT01735175|Secondary|Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles|Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once.|across al cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
1354936|NCT01735175|Secondary|Incidence of Febrile Neutropenia (FN)|FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (“febrile neutropenia”, “neutropenic sepsis”) were taken into account.|across all cycles (18 weeks)|Number of patients with at least one episode of febrile neutropenia by cycle and across all cycles (FAS set)|||Participants|||Count of Participants
1355068|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
1354937|NCT01735175|Primary|Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9 cells/L (grade 4 neutropenia).|21 days (Cycle 1 of chemotherapy treatment)|FAS set = full analysis set; PP set = per protocol set|||days||Standard Deviation|Mean
1354938|NCT01734993|Secondary|Change From Baseline in CRP|Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||milligrams per liter (mg/L)||Standard Deviation|Mean
1354939|NCT01734993|Secondary|Change From Baseline in ESR|Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm/hr||Standard Deviation|Mean
1354940|NCT01734993|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity”. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
1354941|NCT01734993|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population, Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||Units on a scale||Standard Deviation|Mean
1354942|NCT01734993|Secondary|Change From Baseline in Patient's Assessment of Pain|Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety Population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
1354943|NCT01734993|Secondary|Change From Baseline in PtGA of Disease Activity|PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
1354944|NCT01734993|Secondary|Time to Concomitant Corticosteroid Dose Reduction|Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who had concomitant corticosteroid dose reduction.|||Days||Full Range|Median
1354945|NCT01734993|Secondary|Time to Concomitant Corticosteroid Discontinuation|Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here N (number of participants analyzed) represents the participants who discontinued concomitant corticosteroids|||Days||Full Range|Median
1354946|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Dose Reduction||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.|||Percentage of participants|||Number
1354948|NCT01734993|Secondary|Percentage of Participants With Clinical Remission|Clinical remission defined as:DAS28-ESR score < 2.6 and/or SDAI score </= 3.3.DAS28 score is measure of subject’s disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.|Week 48, 108|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given time point.|||Percentage of participants|||Number
1354949|NCT01734993|Secondary|Change From Baseline in SJC|For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||Swollen Joints||Standard Deviation|Mean
1354950|NCT01734993|Secondary|Change From Baseline in TJC|For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||Tender Joints||Standard Deviation|Mean
1354951|NCT01734993|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||Units on a scale||Standard Deviation|Mean
1354952|NCT01734993|Secondary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score|The DAS 28 ESR score is a measure of the participant’s disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient’s global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||Units on a scale||Standard Deviation|Mean
1354953|NCT01734993|Primary|Percentage of Participants With Anti-TCZ Antibodies||Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
1354954|NCT01734993|Primary|Percentage of Participants With Clinically Significant Laboratory Abnormalities|Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
1354990|NCT01734239|Primary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays|Prevaccination and Day 28 after vaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range|||ug/mL||95% Confidence Interval|Mean
1354955|NCT01734993|Primary|Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities|Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (<) 40 beats per minute and value greater than (>) 150 beats per minute, systolic blood pressure (SBP) of < 80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or > 40 degrees Celsius, respiratory rate of <10 or > 50 breaths/minute and criteria for PCI change in physical examination: >/=10% increase or decrease of body weight in kilograms (kg).|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
1354956|NCT01734993|Primary|Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.|Baseline up to approximately 142 weeks|Safety Population|||Percentage of participants|||Number
1354957|NCT01734993|Primary|Percentage of Participants With AESIs Related to TCZ|AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
1354958|NCT01734993|Primary|Percentage of Participants With Adverse Events of Special Interest (AESIs)|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
1354959|NCT01734993|Primary|Percentage of Participants With AEs and SAEs Related to TCZ|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician’s discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
1354960|NCT01734993|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
1354961|NCT01734889|Secondary|The Palatability Scores on Day 3 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.|||units on a scale||Full Range|Median
1354962|NCT01734889|Secondary|The Palatability Scores on Day 2 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 2|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.|||units on a scale||Full Range|Median
1354963|NCT01734889|Secondary|The Palatability Scores on Day 1 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 1|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.|||units on a scale||Full Range|Median
1354964|NCT01734889|Primary|The Acceptability Score for the Last Dose of the Suspension on Day 3 for Subjects < 5 Years|The parents of patients aged <5 years rated their child´s acceptability of the suspension. The following grading was applied: 5 (very well), 4 (well), 3 (neither well nor badly), 2 (badly) and 1 (very badly).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments|||units on a scale||Full Range|Median
1354965|NCT01734889|Primary|The Taste Score for the Last Dose of the Suspension on Day 3 for Subjects 5 - <18 Years|Patients rated the taste of the suspension. The following grading was applied: 5 (very good taste), 4 (good taste), 3 (neither good nor bad taste), 2 (bad taste) and 1 (very bad taste).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments|||units on a scale||Full Range|Median
1354966|NCT01734785|Secondary|Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment|Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)|||kg||Standard Error|Least Squares Mean
1354968|NCT01734785|Primary|HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment|Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term ‘baseline’ was not used to refer to measurements before the administration of open-label medication.|Baseline and 24 weeks|The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.|||Percentage of HbA1c||Standard Error|Least Squares Mean
1354969|NCT01734772|Primary|Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1354970|NCT01734772|Primary|Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1354971|NCT01734655|Primary|Correlation of the MEQ Subscales to the MAAS|The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level|V1||||correlation coefficients|||Number
1354972|NCT01734655|Primary|Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1||||correlation coefficients|||Number
1354973|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1||||correlation coefficients|||Number
1354974|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.|||correlation coefficients|||Number
1354975|NCT01734655|Primary|To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a|"Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a high value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency)."|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.|||Ratio of Variance|||Number
1354976|NCT01734655|Primary|Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)|Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.|SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits||||test-retest coefficent|||Number
1354977|NCT01734551|Secondary|Bayley Scales of Infant and Toddler Development Third Edition|Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15. Scores below 1 standard deviation (= or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain The score for each domain (motor, cognitive, and language functioning) represents the full-scale score|1 year of life|The above number fo reach arm represents the number of subjects who came for follow-up evaluation.|||scores on a scale||Standard Deviation|Mean
1354991|NCT01734161|Primary|Incidence of Post-operative Nausea and/or Vomiting|The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery|48 hours||||Participants|||Count of Participants
1354992|NCT01733953|Secondary|Change From Baseline in Carotid Intima-Media Thickness at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||mm||95% Confidence Interval|Mean
1354993|NCT01733953|Secondary|Change From Baseline in Augmentation Index at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||P2/P1||95% Confidence Interval|Mean
1354978|NCT01734551|Secondary|Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)|The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29 -8.4), Handling (0 - 1), quality of movement (1.20 - 6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43 - 6.67), hypertonicity (0- 8), hypotonicity (0 - 5.0), excitability (0-11), lethargy (0 - 11.0). and stress/abstinence (0. - 0.57). A higher score for each item means a higher level of the construct. For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic. No cut-off score published for normal or abnormal behavioral performance. Reference: Lester BM et al. Summary Statistics of Neonatal Intensive Care Unit Network Neurobehavioral Scale Scores From the Maternal Lifestyle Study: A Quasinormative Sample, in Pediatrics 2004; 113,668.|5-10 days after treatment starts||||scores on a scale||Standard Error|Mean
1354979|NCT01734551|Primary|Duration of Treatment|Total number days of treatment|120 days||||days||Full Range|Median
1354980|NCT01734551|Primary|Finnegan Neonatal Abstinence Scoring System|Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants. The total score ranges from 0 to 43. Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2(1-2):141-58. Although normal newborn may manifest mild symptoms that will give scores in the range of 0 to 7. A score of 8 consecutively obtained times 3 indicate that infant will benefit from treatment, in this study morphine or clonidine. A decrease in scores especially to less than 8 is suggestive of a good response to treatment.|14 days||||scores on a scale||Standard Deviation|Mean
1354981|NCT01734395|Secondary|Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)|MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients’ cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria|||Units on a scale||Standard Deviation|Mean
1354982|NCT01734395|Primary|Change From Baseline at Week 16 in Burden Interview (BI) Scores|BI is designed to evaluate subjective stress dementia patients’ caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.|||Units on a scale||Standard Deviation|Mean
1354983|NCT01734395|Primary|Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)|AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant’s attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.|Baseline (Week 1 [Day 1]), Week 16|FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.|||Units on a scale||Standard Deviation|Mean
1354984|NCT01734317|Secondary|Pain|Pain before, during and after dressing removal will be meausered.|After 14/21 days treatment|||||||
1354985|NCT01734317|Primary|Efficacy|Healing at day 14. Healing was defined as ≥95% epithelialisation.|14 days||||participants|||Number
1354986|NCT01734239|Primary|Number of Participants Reporting Serious Adverse Experiences|A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention|Up to Day 28 postvaccination|The All Subjects as Treated population included all enrolled participants|||Number of participants|||Number
1354987|NCT01734239|Primary|Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.|Up to Day 14 postvaccination|The All Subjects as Treated population included all enrolled participants|||Number of participants|||Number
1354988|NCT01734239|Primary|Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)||Up to 5 days postvaccination|The All Subjects as Treated population included all enrolled participants|||Number of participants|||Number
1354989|NCT01734239|Primary|Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.|Day 28 postvaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range|||Percentage of participants||95% Confidence Interval|Number
1354994|NCT01733953|Secondary|Change From Baseline in Pulse Wave Velocity at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||m/s||95% Confidence Interval|Mean
1354996|NCT01733953|Secondary|Change From Baseline in Carotid Artery Compliance at 6-Months|Carotid Artery Compliance is a measure of arterial stiffness. Higher arterial stiffness places persons at higher risk for CVD.|Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||mm/mmHg x 10^-3||95% Confidence Interval|Mean
1354997|NCT01733953|Primary|Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months||Baseline and 6-Months|Physician withdrawals, loss to follow-up, drug compliance <70%, unrelated injury, and self-withdrawal reduced number analyzed. Also, participant movement during FMD assessment and/or poor ultrasound image quality due to difficult brachial artery anatomy or poor circulation led to some unusable data and thus lowered the analyzable sample size.|||percentage change||95% Confidence Interval|Mean
1354998|NCT01733758|Secondary|Time to Study Withdrawal for Any Reason|Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.|Baseline through Week 52|Intent-to-Treat Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least one post-Baseline assessment (scheduled or unscheduled) of the primary endpoint, HbA1c.|||Weeks||95% Confidence Interval|Median
1354999|NCT01733758|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.|Baseline through Week 52|Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.|||Weeks||95% Confidence Interval|Median
1355000|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.|||Kilograms (kg)||Standard Deviation|Mean
1355001|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 24|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.|||Kilograms (kg)||Standard Deviation|Mean
1355002|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1355003|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1355004|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.|||Percentage of participants|||Number
1355005|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.|Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.|||Percentage of participants|||Number
1355069|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
1355070|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
1355006|NCT01733758|Secondary|Change From Baseline in HbA1c at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1355007|NCT01733758|Primary|Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1355008|NCT01733758|Primary|Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1355009|NCT01733745|Secondary|Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses|The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.|||units on a scale|Eyes|Standard Deviation|Mean
1355010|NCT01733745|Secondary|Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses|The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.|||units on a scale|Eyes|Standard Deviation|Mean
1355011|NCT01733745|Primary|Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)|Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.|||functioning glands|Eyes|Standard Deviation|Mean
1355012|NCT01733732|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) by Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||mmHg|eyes|Standard Deviation|Mean
1355013|NCT01733732|Secondary|Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit|Dry eye status was assessed using the Schirmer’s test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||millimeters|eyes|Standard Deviation|Mean
1355071|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
1355072|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
1355014|NCT01733732|Secondary|Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||percentage of cells||Standard Deviation|Mean
1355015|NCT01733732|Secondary|Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit.|||percentage of cells|eyes|Standard Deviation|Mean
1355016|NCT01733732|Secondary|Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30|A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||pg/mL||Standard Deviation|Mean
1355017|NCT01733732|Secondary|Mean Change From Baseline in Ocular Surface Staining by Visit|Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||units on a scale|eyes|Standard Deviation|Mean
1355018|NCT01733732|Secondary|Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit|TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||millimeters|eyes|Standard Deviation|Mean
1355019|NCT01733732|Secondary|Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit|NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||seconds|eyes|Standard Deviation|Mean
1355020|NCT01733732|Secondary|Meibomian Gland Expression|Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||units on a scale|eyes|Standard Deviation|Mean
1355021|NCT01733732|Secondary|Percentage of Eyes With Normal Slit-lamp Assessment|An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||percentage of eyes|eyes||Number
1355022|NCT01733732|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit|BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||LogMAR||Standard Deviation|Mean
1355047|NCT01733121|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)|||units on a scale||95% Confidence Interval|Least Squares Mean
1355023|NCT01733732|Primary|Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit|The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1355024|NCT01733680|Secondary|The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)|"BRIEF-A is a 75 item self report questionnaire that measures behavior and executive function. For each item the subject is asked during the past month, how often has each of the following behaviors been a problem?: The choices are N (never), S (sometimes), O (Often). Total score for the Global Executive Composite used. Raw data were transformed into t-scores, which are standardized scores that indicate the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. Values less than 65 indicate executive function is not a problem and values greater than 65 indicate executive function is often a problem."|8 weeks|Statistical analysis of the outcome data was not done due to the small N of each group|||Global Executive Composite T Score||90% Confidence Interval|Mean
1355025|NCT01733680|Secondary|AISRS, Adult ADHD Investigator Rating Scale|An 18 item clinician administered questionnaire to evaluate ADHD in adults. Responses to questions were 0-None, 1-Mild, 2-Moderate, 3-Severe. A decrease of 30% in the total score would be considered improvement. Total score range is 0-54. A lower score indicates improvement in symptoms. A score of 24 or more indicates symptomatic ADHD.|8 weeks|Statistical analysis of the outcome data was not done due to the small N.|||Total score||Full Range|Mean
1355026|NCT01733680|Primary|Improvement in CGI|CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse|8 weeks|There was no statistical analysis done due to the small number of participants in the study|||Units on a scale||Full Range|Mean
1355027|NCT01733368|Secondary|Number of Responder Patients With Conventional Left Ventricular Pacing Vector|"Response is defined as a reduction >15% in LVESV, measured 6 months after implant.~Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads."|6 months after implant|Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector|||Participants|||Count of Participants
1355028|NCT01733368|Secondary|Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector|"Response is defined as a reduction >15% in LVESV, measured 6 months after implant.~Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads."|6 months after implant|Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector|||Participants|||Count of Participants
1355029|NCT01733368|Primary|Safety Outcomes in CRT Responders and Non-Responders|"Mortality rate,~Rate of cardiovascular hospitalizations and for any cause or~Combined endpoint (death and all-cause hospitalization)"|6 months after implant|Patients experiencing clinical safety event prior to the 6-month follow-up visit.|||Participants|||Count of Participants
1355030|NCT01733368|Primary|Number of Responder Patients (Structural Remodelling)|Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.|6 months after implant|Patients with the 6-month follow-up completed and echocardiographic measurements available|||Participants|||Count of Participants
1355031|NCT01733329|Secondary|Blood Loss||24 hours||||mL||Standard Deviation|Median
1355032|NCT01733329|Secondary|Postpartum Hemorrhage|"Defined as:~Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion"|24 HOURS||||percentage of patients|||Number
1355033|NCT01733329|Secondary|Uterine Atony|Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, “boggy” uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.|24 hours||||percentage of participants|||Number
1355034|NCT01733329|Primary|Need for Additional Uterotonic Medications|The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.|24 hours||||percentage of participants|||Number
1355035|NCT01733316|Secondary|Halitosis Substudy: Expired Air DMS Concentrations|Participants who reported halitosis (“bad breath”) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose 30 min post-dose, 2, 3, 4 and 6 hours post-dose. While taking RP103 (Month 4, 5, or 7): Within 15 min. prior to morning dose. 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||nmol/L||Standard Deviation|Mean
1355036|NCT01733316|Secondary|Area Under the Plasma Concentration Time Curve From Time Point 0 Through the Last Measurable Point (AUC0-t) for Plasma Cysteamine|Participants who reported halitosis (“bad breath”) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||hr*mg/L||Standard Deviation|Mean
1355037|NCT01733316|Secondary|Halitosis Substudy: Time to Cmax (Tmax) for Plasma Cysteamine|Participants who reported halitosis (“bad breath”) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||hour||Standard Deviation|Mean
1355038|NCT01733316|Secondary|Halitosis Substudy: Maximum Plasma Concentration (Cmax) for Plasma Cysteamine|Participants who reported halitosis (“bad breath”) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of dimethylsulfide (DMS) in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state pharmacokinetic (PK) samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered.|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||mg/L||Standard Deviation|Mean
1355039|NCT01733316|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|AE: any untoward medical occurrence that does not necessarily have a causal relationship with study drug. SAE: any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is medically significant, and though not included in the above list, is an important medical event, according to the Investigator. Treatment-emergent adverse events (TEAEs) occurred after first dose of study drug. Clinically significant abnormalities in laboratory values (hematology, blood chemistry, urinalysis), electrocardiograms (ECGs), vital signs, and physical examinations were to be reported as adverse events and so are included in this summary of TEAEs|From first dose of study drug to 7 days after last dose. Median duration of exposure was 91 days (range 82-108) for Cystagon® phase, 119 days (range 98-137) for the RP103 phase, and 861 days (range 30 - 1350) during the long-term RP-103 phase.|"Safety Analysis Set: all participants who received at least 1 dose of study drug (RP103). The row At least 1 TEAE includes both serious and non-serious AEs."|||Participants|||Count of Participants
1355040|NCT01733316|Primary|Average Difference Between Morning and Non-Morning Log White Blood Cell (WBC) Cystine Values|The primary analysis of WBC cystine was performed using the natural log transformed WBC cystine level; the log transformation is a normalizing transformation. For each participant, the difference between the morning and corresponding non-morning log WBC cystine value (non-morning minus morning) at each monthly visit during the Cystagon® phase (Months 1, 2, and 3) was computed and these differences were averaged. The average difference between morning and non-morning log WBC cystine value was similarly computed for each participant during the RP103 phase (Months 5, 6, and 7). The primary analysis compared within-subject pairs (Cystagon® phase paired with RP103 phase) of non-morning minus morning average differences of log WBC cystine level.|While taking Cystagon® (Months 1, 2, 3): within 15 minutes pre-morning (AM) and pre-non AM dose. During 3 months of RP103 (Months 5, 6, 7): 30 minutes post-AM and post-evening (PM) dose.|Pharmacodynamic (PD) Analysis Set: All participants who received at least one treatment of Cystagon® and RP103 and who had at least one WBC cystine level recorded after each of Cystagon® treatment and RP103 treatment. Only participants with an average difference during both the Cystagon® and RP103 phases were included.|||log [nmol ½ cystine/mg protein]||Standard Deviation|Mean
1355041|NCT01733277|Other Pre-specified|Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)||Baseline||||mg/L||Standard Deviation|Mean
1355042|NCT01733277|Secondary|Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain|The WOMAC measures pain (score range 0–20), stiffness (score range 0–8), and functional limitation (score range 0–68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.|Baseline||||units on a scale||Standard Deviation|Mean
1355043|NCT01733277|Primary|Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain||Baseline|Number of participant analyzed Per-protocol|||participants|||Number
1355044|NCT01733212|Primary|Occurrence of Intra-operative and Post-operative Vomiting|Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.|During surgery (1 hour) and thru 72 hours after surgery|Number of participants who had vomiting in each group is compared to the other group using Chi square test|||Participants|||Count of Participants
1355045|NCT01733121|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters’ AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)|||units on a scale||95% Confidence Interval|Least Squares Mean
1355046|NCT01733121|Secondary|AIMS Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)|||units on a scale||95% Confidence Interval|Least Squares Mean
1355048|NCT01733121|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline and Week 6|Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters’ AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)|||units on a scale||Standard Error|Least Squares Mean
1355049|NCT01733069|Primary|APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type|Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)|Baseline|Results for 4 gender-specific sample types were reported for 2 targets (CT, Chlamydia trachomatis; and GC, Neisseria gonorrhoeae infection). In this observational study, 1313 females (143 CT and/or GC-infected) and 549 males (121 CT and/or GC infected) contributed to one or more analyses.|||participants|||Number
1355050|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against pandemic H1N1 strains before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days||||participants|||Number
1355051|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against H3N2 Perth before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days||||participants|||Number
1355052|NCT01732926|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from randomization to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
1355053|NCT01732926|Secondary|Lymph Node Response Rate|Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355054|NCT01732926|Secondary|Overall Response Rate (ORR)|Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355055|NCT01732926|Secondary|Complete Response Rate (CR)|Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355056|NCT01732926|Primary|Progression-free Survival (PFS)|PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355057|NCT01732913|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
1355058|NCT01732913|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355059|NCT01732913|Secondary|Lymph Node Response Rate|Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355060|NCT01732913|Secondary|Overall Response Rate|Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355061|NCT01732913|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
1355062|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min/m^2||Standard Deviation|Mean
1355063|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min/m^2||Standard Deviation|Mean
1355064|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min||Standard Deviation|Mean
1355074|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
1355075|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Deviation|Mean
1355076|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||g||Standard Deviation|Mean
1355077|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||g||Standard Deviation|Mean
1355078|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
1355079|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
1355080|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
1355081|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
1355082|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 2 Years|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years|Participants with an evaluation of this measure.|||participants|||Number
1355083|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 6 Months|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months|Participants with an evaluation of this measure.|||participants|||Number
1355084|NCT01732835|Secondary|Aortic Insufficiency (AI) at 2 Years|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years|Participants with an echocardiogram evaluable for this measure.|||participants|||Number
1355085|NCT01732835|Secondary|Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure||2 years||||percentage of participants||95% Confidence Interval|Number
1355086|NCT01732835|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|6 months||||percentage of participants||95% Confidence Interval|Number
1355087|NCT01732835|Secondary|Implant Procedure Success|Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.|discharge or 14 days postprocedure, whichever comes first||||percentage of implant procedures||95% Confidence Interval|Number
1355088|NCT01732835|Primary|Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months|Participants with an echocardiogram evaluable for this measure.|||participants|||Number
1355089|NCT01732835|Primary|Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure||6 months||||percentage of participants||95% Confidence Interval|Number
1355090|NCT01732822|Other Pre-specified|Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event|Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the saftey analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
1355091|NCT01732822|Other Pre-specified|PLATO Major Bleeding Events|Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
1355092|NCT01732822|Other Pre-specified|TIMI Major or Minor Bleeding Events|Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
1355107|NCT01732822|Secondary|ALI|Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355093|NCT01732822|Other Pre-specified|TIMI Major Bleeding Events|Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
1355094|NCT01732822|Other Pre-specified|CV-related Hospitalization|Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, transient ischemic attack (TIA), coronary revascularization or unstable angina. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355095|NCT01732822|Other Pre-specified|Major Amputation Caused by PAD|Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355096|NCT01732822|Other Pre-specified|Any Amputation Caused by PAD|Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355097|NCT01732822|Other Pre-specified|Change in ABI/TBI From Baseline|"Change in ankle brachial index (ABI) / toe brachial index (TBI).~Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):~Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4~Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:~Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Change in ABI/TBI||Standard Deviation|Mean
1355098|NCT01732822|Other Pre-specified|Changes in Rutherford Classification|"Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.~Category 0 – Asymptomatic Category 1 – Mild claudication Category 2 – Moderate claudication – The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Category 3 – Severe claudication Category 4 – Rest pain Category 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 – Severe ischemic ulcers or frank gangrene"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355099|NCT01732822|Other Pre-specified|Changes in Fontaine Stage|"Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.~Stage I – Asymptomatic Stage IIa – Intermittent claudication after more than 200 meters of pain free walking Stage IIb – Intermittent claudication after less than 200 meters of walking Stage III – Rest pain Stage IV – Ischemic ulcers or gangrene"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355100|NCT01732822|Other Pre-specified|Non-CV Death|Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355101|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)|Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355102|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)|Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355103|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)|Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355104|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)|Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355105|NCT01732822|Secondary|Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])|Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355106|NCT01732822|Secondary|Lower Extremity Revascularization|Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355134|NCT01732783|Primary|Maximum Dose of Panitumumab||12 months||||mg||Inter-Quartile Range|Median
1355135|NCT01732783|Primary|Cumulative Dose of Panitumumab||12 months||||mg||Inter-Quartile Range|Median
1355108|NCT01732822|Secondary|Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)|Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355109|NCT01732822|Secondary|All-cause Mortality|Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355110|NCT01732822|Secondary|MI|Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355111|NCT01732822|Secondary|CV Death|Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355112|NCT01732822|Secondary|Composite of CV Death, MI, Ischemic Stroke, and ALI|Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
1355113|NCT01732822|Primary|Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke|Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
1355114|NCT01732796|Secondary|SVR24|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).|24 Week (post-treatment)|FAS|||Percantage of participants|||Number
1355115|NCT01732796|Secondary|SVR4|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).|4 Week (post-treatment)|FAS|||Percentage of participants|||Number
1355116|NCT01732796|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS|||Percentage of participants|||Number
1355117|NCT01732796|Primary|SVR12 Rates With Historical Control|Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint|12 Week (post-treatment)|The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).|||Percentage of participants|||Number
1355118|NCT01732783|Secondary|Type of Post-Panitumumab Anti-cancer Treatment|Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.|12 months|Participants who reported use of anti-cancer treatment after discontinuation of panitumumab|||participants|||Number
1355119|NCT01732783|Secondary|Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation||12 months||||participants|||Number
1355120|NCT01732783|Secondary|Number of Participants With Resectability|Resectability denotes whether a participant became resectable during the study.|12 months||||Participants|||Count of Participants
1355121|NCT01732783|Secondary|Percentage of Participants With an Overall Response|Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).|12 months|Participants with tumor response data post-baseline|||percentage of participants||95% Confidence Interval|Number
1355122|NCT01732783|Secondary|Reasons for Hospitalization|Participants may have had more than one hospital visit and/or reason for a hospital visit.|12 months|Participants with at least one hospitalization|||participants|||Number
1355123|NCT01732783|Secondary|Duration of Hospital Stay||12 months|Participants with at least one hospital visit|||days||Inter-Quartile Range|Median
1355124|NCT01732783|Secondary|Types of Hospital Visit|Participants may have had more than one type of hospital visit.|12 months|Participants with at least one hospital visit|||participants|||Number
1355125|NCT01732783|Secondary|Number of Participants With at Least One Hospitalization||12 months||||Participants|||Count of Participants
1355126|NCT01732783|Primary|Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay||12 months||||percentage of participants|||Number
1355127|NCT01732783|Primary|Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction||12 months||||percentage of participants|||Number
1355128|NCT01732783|Primary|Duration of Exposure of All Concomitant Chemotherapy|Duration of exposure is the time from the first date to the last date of chemotherapy administration.|12 months||||months||Inter-Quartile Range|Median
1355129|NCT01732783|Primary|Reasons for Discontinuation of Panitumumab||12 months|Participants who discontinued panitumumab while on study|||Participants|||Count of Participants
1355130|NCT01732783|Primary|Percentage of Participants With at Least One Panitumumab Dose Delay||12 months||||percentage of participants||95% Confidence Interval|Number
1355131|NCT01732783|Primary|Percentage of Participants With at Least One Panitumumab Dose Reduction||12 months||||percentage of participants||95% Confidence Interval|Number
1355132|NCT01732783|Primary|Mean Interval Between Panitumumab Infusions||12 months||||Participants|||Count of Participants
1355133|NCT01732783|Primary|Duration of Panitumumab Exposure|Duration of exposure is the time from the first to the last panitumumab infusion|12 months||||months||Inter-Quartile Range|Median
1355137|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
1355138|NCT01732770|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
1355139|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis|BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
1355140|NCT01732770|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis|Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set includes all randomized participants who have a baseline BMD measurement and at least one postbaseline BMD measurement. Any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, last observation carried forward [LOCF]).|||percent change||95% Confidence Interval|Least Squares Mean
1355141|NCT01732757|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355142|NCT01732757|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355143|NCT01732757|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355144|NCT01732757|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355145|NCT01732757|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355146|NCT01732757|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355147|NCT01732757|Secondary|Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0|Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).|Day 0|All randomized subjects with data at this time point|||Percentage of Subject Eyes|Participants||Number
1355148|NCT01732757|Secondary|Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.|Day 0|All randomized subjects with data at this time point|||Percentage of Subjects|||Number
1355149|NCT01732757|Secondary|Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.|Day 0|All randomized subjects with data at this time point|||Percentage of Subjects|||Number
1355150|NCT01732757|Secondary|Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355151|NCT01732757|Primary|Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0 at 3 Minutes Post Challenge|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
1355152|NCT01732692|Secondary|Percentage of Patients Who Experienced Adverse Events (AEs)|An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.|From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.|Safety population|||percentage of participants|||Number
1355153|NCT01732692|Secondary|Patient Compliance – Amount of Additional Clear Liquid Consumed|To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.|1 day (the day of colonoscopy)|Intent-to-treat population with available data|||ml||Standard Deviation|Mean
1355154|NCT01732692|Secondary|Total Compliance Score|"Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).~Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre."|1 day (the day of colonoscopy)|Intent-to-treat with available data|||units on a scale||Standard Deviation|Mean
1355155|NCT01732692|Secondary|Patient Satisfaction of Colonoscopy Preparation (VAS)|"Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as totally unacceptable (lowest patient satisfaction of colonoscopy preparation) and 100 is fully acceptable (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant."|1 day (the day of colonoscopy)|Intent-to-treat population with available VAS data.|||units on a scale||Standard Deviation|Mean
1355156|NCT01732692|Primary|Percentage of Participants With Successful Colon Cleansing|Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.|1 day (the day of colonoscopy)|Intent-to-treat population|||percentage of participants|||Number
1355157|NCT01732640|Secondary|Overall Response After Chemoradiation|To estimate the overall response rate after completion of chemoradiation|5 years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
1355158|NCT01732640|Secondary|Correlate Standard Imaging Pre and Post Treatment|To correlate the response with standard imaging CT/MRI and FDG PET pre and post treatment.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
1355159|NCT01732640|Secondary|Activity of Afatinib Based on Serial FLT-PET/CT and DW-MRI|To estimate the activity of afatinib by obtaining serial FLT-PET/CT and DW-MRI, And compare to standard of care CT images (which will be acquired at baseline and at the completion of treatment, and categorized per RECIST criteria) and correlated with response.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
1355160|NCT01732640|Secondary|Biological Marker Activity of Afatinib|To estimate the biological marker activity of afatinib by serial sampling of tumor and blood samples from patients, and correlate with clinical and pathological response and outcomes. On- and off-target effects of afatinib will be assessed for the biological marker activity.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
1355161|NCT01732640|Secondary|Median Overall Survival at 2 Years|To estimate the median overall survival.|2 Years|Patients were taken off study before the full 2 years could be completed, therefore data was not collected for this outcome measure.||||||
1355162|NCT01732640|Secondary|2 Year Progression Free Survival (PFS)|To estimate the 2 year progression free survival.|2 Years|Patients were taken off study before the full 2 years could be completed, therefore data was not collected for this outcome measure.||||||
1355163|NCT01732640|Secondary|Overall Response After Chemoradiation|To estimate the overall response rate after completion of chemoradiation.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
1355164|NCT01732640|Primary|Number of Participants With Dose Limiting Toxicities|Grade 3 or 4 neutropenia (ie. absolute neutrophil count <1000 cells/mm^3) that was associated with a fever>38.5 degrees C or lasting longer than 5 days, grade 3 thrombocytopenia with bleeding or grade 4 thrombocytopenia, and any grade 3 or 4 non-hematologic toxicity per CTCAE criteria which were probably or definitely related to study therapy. During the chemoradiation, an event of stomatitis, pharyngitis, mucositis, or dermatitis was not considered to be a dose limiting toxicity unless it was a grade 4 that did resolve to <grade 2 with a radiation treatment break (not to exceed 10 days) or with withholding chemotherapy (not to exceed 2 weekly doses).|1 year (average)||||Participants|||Count of Participants
1355165|NCT01732640|Primary|Objective Tumor Response|Patients were accessed for response by CT/MRI and clinical exam. Partial response was defined as a greater than 30 % reduction in tumor size.|After completion of 2 cycles of induction chemotherapy (at least 8 weeks)||||Participants|||Count of Participants
1355166|NCT01732640|Primary|Maximum Tolerated Dose (MTD) of Afatinib|The maximally tolerated dose (MTD) was defined as the dose of afatinib in which <2 of 6 patients experience a DLT with the next higher dose having at least 2 of up to 6 patients experiencing a DLT. No dose escalations or de-escalations are permitted within each subject's treatment.|1 Year (Average)||||mg|||Number
1355167|NCT01732588|Secondary|OZ439 Tmax|Time of maximum observed plasma drug concentrations (Tmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."|||hours||Full Range|Median
1355168|NCT01732588|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355169|NCT01732588|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1355170|NCT01732549|Secondary|Safety Profile of Tasquinimod|Number of subjects reporting adverse events|At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)|Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received|||participants|||Number
1355171|NCT01732549|Secondary|Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score|"Baseline is defined as last measurement collected prior to the first dose of study drug. End of Study visit (within 14 days of last dose of study treatment)~The EQ-5D, a 5-item scale useful in health resource utilisation and cost comparisons between treatment groups designed for self-completion by patients consists of two pages [EQ-5 descriptive system and EQ Visual Analogue Scale(VAS)]. The EQ-5 descriptive system comprises five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS. The respondents are asked to mark health status on the day of the interview on a 10cm vertical scale with end points of 0 to100. There are notes at the both ends of the scale that the bottom rate(0) corresponds to the worst health you can imagine, and the highest rate(100) corresponds to the best health you can imagine"|Baseline and End-of-study Visit (approximately up to 2.5 years)|ITT population|||Score on scale||Inter-Quartile Range|Median
1355172|NCT01732549|Secondary|Time to Deterioration in Functional Assessment of Cancer Therapy – Prostate (FACT-P)|"End of Study visit (within 14 days of last dose of study treatment)~Impact of tasquinimod on health related quality of life (QoL) - Analysis of time to deterioration in FACT-P~The FACT-P measurement system is a validated collection of health related quality of life (HRQOL) questionnaires used to assess HRQOL in men with prostate cancer. It is appropriate for use with patients with any form of cancer and extensions of it have been used and validated in other chronic illness condition. The FACT-P is a self-administered 39-item scale comprising five domains: physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns. The individual subscale scores range from 0 to a high between 24 and 48 and the total score ranges between 0 and 156, with higher scores representing better Quality of Life (QoL)"|Up to End of Study visit (approximately up to 2.5 years)|ITT population|||weeks||90% Confidence Interval|Median
1355173|NCT01732549|Secondary|Time to Further Anticancer Treatment for Prostate Cancer|Time from randomisation to further treatment for prostate cancer|Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)|ITT population|||weeks||90% Confidence Interval|Median
1355174|NCT01732549|Secondary|Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death|"Symptomatic PFS is defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first [symptomatic progression as assessed by Brief Pain Inventory (BPI) and analgesic use].~Symptomatic progression was defined by the occurrence of pain with documented disease, skeleton related adverse events.~The median symptomatic PFS for placebo and tasquinimod groups was not reached.~Tasquinimod: Patients censored = 48, Patients at risk (t=0) = 71 Placebo: Patients censored = 54, Patients at risk (t=0) = 73"|Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)|ITT Population|||participants|||Number
1355258|NCT01732263|Primary|Time of Maximum Plasma Concentration (Tmax) for SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||hours||Full Range|Median
1355175|NCT01732549|Secondary|Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)|"The time from the date of randomisation to the date of radiological progression free survival [PFS] on next-line therapy (PFS 2) or death due to any cause.~Radiological progression was defined~- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions~- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)|ITT Population|||weeks||90% Confidence Interval|Median
1355176|NCT01732549|Secondary|Overall Survival Based on Number of Subjects Who Died|"Overall survival is defined as the time from randomisation to death due to any cause.~The number of participants who died is presented since the Median was not reached for this assessment.~Tasquinimod: Patients censored = 63, Patients at risk (t=0) = 71 Placebo: Patients censored = 67, Patients at risk (t=0) = 73"|Every 3 months after study treatment stop until death (approximately up to 2.5 years)|ITT Population|||participants|||Number
1355177|NCT01732549|Primary|Time to Radiological Progression Free Survival [PFS]|"The time from the date of randomisation to the date of radiological progression or death due to any cause.~Radiological progression was defined~- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions~- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 8 weeks until disease progression documentation (approximately up to 2.5 years)|Intention to treat (ITT) Population|||weeks||90% Confidence Interval|Median
1355178|NCT01732536|Secondary|Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)|"To be indicated for RESS, the following criteria had to be met:~Continued to use topical intranasal steroids daily;~Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use~Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and~Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade >=2 on at least one side)"|90 days, 6 months|Intent-to-treat population consisted of all patients in whom an implant or sham procedure was attempted. There were 2 (2.0%) participants (1 treatment, 1 control) who withdrew from the study prior to Day 90. No imputation of missing values was performed.|||Participants|||Count of Participants
1355179|NCT01732536|Secondary|Nasal Obstruction Symptom Evaluation (NOSE) Score|NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.|6 months|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1355180|NCT01732536|Secondary|Bilateral Polyp Grade|Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.|90 days, 6 months|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at 90 days and 4 (4.0%) participants (2 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.|||units on a scale||Standard Error|Mean
1355181|NCT01732536|Secondary|Ethmoid Sinus Obstruction|Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.|90 days|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There was1 (1.0%) participant (treatment) with missing values at baseline and Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1355182|NCT01732536|Primary|Bilateral Polyp Grade|Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.|90 days|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 2 (2%) participants (2 treatment, 0 control) with missing values. No imputation of missing values was performed. Negative values for change from baseline represent improvement.|||units on a scale||Standard Deviation|Mean
1355183|NCT01732536|Primary|Nasal Obstruction/Congestion Score|Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in|90 days|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3%) participants (1 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
1355513|NCT01729026|Secondary|Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)|Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD|Baseline and 3-month and 6-month follow-up|||||||
1355184|NCT01732510|Secondary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation|Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).|Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224|The ADA evaluable population defined as all participants with at least one ADA sample available after treatment with MK-8226 or placebo was used for analysis.|||Participants|||Number
1355185|NCT01732510|Secondary|Percentage of Participants With >=50% Improvement in EASI Score|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355186|NCT01732510|Other Pre-specified|Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2|Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355187|NCT01732510|Secondary|Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2|Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.|Up to Week 12|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355188|NCT01732510|Secondary|Change From Baseline in Participant Sleep Disturbance in Study Part 2|Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355189|NCT01732510|Secondary|Change From Baseline in Participant Pruritus in Study Part 2|Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355190|NCT01732510|Secondary|Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2|The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant’s subjective score.|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355191|NCT01732510|Secondary|Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2|Percentage of participants achieving an IGA of atopic dermatitis of “clear-0” or “almost clear-1”. The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease).|Baseline, Week 4, Week 8, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355192|NCT01732510|Secondary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 4, Week 8, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355259|NCT01732263|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
1355193|NCT01732510|Secondary|Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration|t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (t1/2) from at least one treatment was used for analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
1355194|NCT01732510|Secondary|Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration|Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (Vd) from at least one treatment was used for analysis.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1355195|NCT01732510|Secondary|Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration|CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (CL) from at least one treatment was used for analysis.|||mL/day/kg||Geometric Coefficient of Variation|Geometric Mean
1355196|NCT01732510|Secondary|Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration|Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (Cmax) from at least one treatment was used for analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1355197|NCT01732510|Secondary|AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration|AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (AUC0-last) from at least one treatment was used for analysis.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1355198|NCT01732510|Secondary|Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration|AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The Per-Protocol (PP) population defined as all participants compliant with study procedure with data available (AUC0-tau) from at least one treatment was used for analysis.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1355199|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2|CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355200|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2|CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from Baseline [BL] in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
1355514|NCT01729026|Secondary|Physical Activity Questionnaire (PAQ)|Self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months.|Baseline and 3-month and 6-month follow-up|||||||
1355201|NCT01732510|Primary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1|Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12|The Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of study treatment with baseline and at least one post-dose assessment (EASI) was used for analysis.|||Score on a scale||Standard Deviation|Mean
1355202|NCT01732510|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 12 Weeks|The ASaT population defined as all participants who received at least one dose of investigational drug was used for analysis.|||participants|||Number
1355203|NCT01732510|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 32 Weeks|The All Subjects as Treated (ASaT) population defined as all participants who received at least one dose of investigational drug was used for analysis.|||participants|||Number
1355204|NCT01732484|Secondary|Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy|Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values|3 years||||percentage of eyes|Participants||Number
1355205|NCT01732484|Primary|Posterior Capsule Opacification (PCO)|PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)|3 years||||units on a scale (0-10)||Standard Deviation|Mean
1355206|NCT01732471|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Overall Safety Population|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 11|Overall safety population included all participants who received at least 1 dose of investigational medicinal product.|||participants|||Number
1355207|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Sub-population of Responders|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Sub-population of responders included participants with reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.|||percent change||Standard Deviation|Mean
1355208|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Overall Population|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.|||percent change||Standard Deviation|Mean
1355209|NCT01732471|Primary|Percentage of Participants With Response to Kuvan® (Sapropterin Dihydrochloride) Treatment|Response to Kuvan® (sapropterin dihydrochloride) treatment was defined as a reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.|Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.|||percentage of participants||95% Confidence Interval|Number
1355210|NCT01732458|Primary|Percentage of Participants Discontinuing Study Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.|From pre-operative phase up to Follow-up (Day 1 to Day 15)|All randomized participants who received at least one dose of study treatment were analyzed.|||percentage of participants|||Number
1355260|NCT01732263|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*h/ml||Standard Deviation|Mean
1355211|NCT01732458|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.|From pre-operative phase up to Follow-up (Day 1 to Day 15)|All randomized participants who received at least one dose of study treatment were analyzed.|||percentage of participants|||Number
1355212|NCT01732458|Primary|Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose|Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.||||||
1355213|NCT01732458|Primary|Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose|Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.||||||
1355214|NCT01732458|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose|Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.||||||
1355215|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355216|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355254|NCT01732445|Primary|Best Overall Response Rate as Determined by International Working Group Criteria|Best overall response rate as determined by International Working Group criteria: An evaluable patient will be classified as a responder for the primary endpoint if the patient’s best overall response is CR, PR or CI (Clinical Improvement) as determined by International Working Group Criteria over all cycles of study treatment. The percentage of successes will be estimated by the number of successes (defined as complete response, partial response, or clinical improvement) divided by the total number of evaluable patients times 100. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 2 years||||percentage of patients with CR, PR or CI||95% Confidence Interval|Number
1355217|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355218|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355219|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355220|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355221|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355222|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355255|NCT01732263|Primary|Volume of Distribution (Vz/F) of SSP-004184|The distribution of a medication between plasma and the rest of the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||L/kg||Standard Deviation|Mean
1355223|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355224|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355225|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355226|NCT01732458|Primary|AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355227|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355228|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355261|NCT01732107|Other Pre-specified|Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.|Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy|12 months|9 subjects had sufficient tissue available to measure dovitinib tissue concentration|||nmol/L|||Number
1355229|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355230|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355231|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355232|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355233|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355234|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355262|NCT01732107|Other Pre-specified|Characterize Concordance Rates Between UC Patient Detected Tumor, Urine, and Circulating Free Plasma FGFR3 Mutations.|Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355235|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355236|NCT01732458|Primary|Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355237|NCT01732458|Primary|Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355238|NCT01732458|Primary|AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355239|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355240|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due to aprepitant concentration in the pre-dose sample.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355256|NCT01732263|Primary|Total Body Clearance (CL/F) of SSP-004184|The rate at which a drug is removed from the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||L/h/kg||Standard Deviation|Mean
1355241|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. Two participants were excluded from the analysis, due to a missing 8-hour post-dose sample and aprepitant concentration in the pre-dose sample, respectively.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355242|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355243|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355244|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355245|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
1355246|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355515|NCT01729026|Secondary|Patient Health Questionnaire-9 (PHQ-9)|Self-rating scale that assesses the presence and severity of the symptoms of a DSM-IV major depressive episode|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
1355247|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355248|NCT01732458|Primary|Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hour (hr)||Geometric Coefficient of Variation|Geometric Mean
1355249|NCT01732458|Primary|Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355250|NCT01732458|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1355251|NCT01732445|Other Pre-specified|Patient-reported Symptoms Assessed Using the MPN-SAF, as Measured by the Percentage of Patients With a Decrease in MPN-SAF TSS Greater Than 50% From Baseline|Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) will be analyzed using published scoring algorithms. MPN-SAF includes 27 items scored on a scale of 0 to 10. The MPN-SAF Total Symptom Score (TSS) (range 0-100) was computed according to the published scoring algorithm. Higher scores represent worse symptom burden. The percentage of patients with a decrease in MPN-SAF TSS greater than 50% from baseline and 95% confidence interval are reported below.|Baseline to up to 2 years||||percentage of patients||95% Confidence Interval|Number
1355252|NCT01732445|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 2 years||||percentage of patients|||Number
1355253|NCT01732445|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. The median and 95% confidence interval are reported below.|From registration to death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
1355257|NCT01732263|Primary|Plasma Half-Life (T 1/2) of SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||hours||Standard Deviation|Mean
1355263|NCT01732107|Other Pre-specified|Characterize Associations Between Post-treatment Hypertension, 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.|Hypertension will be defined as a systolic blood pressure (SBP) of > 140 mmHg or a diastolic blood pressure (DBP) of > 90 mm Hg recorded at any time after dovitinib therapy is initiated.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355264|NCT01732107|Other Pre-specified|Characterize Associations Between Pre-treatment Germline VEGFR SNPs and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.|Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC’s (collected prior to initiating dovitinib therapy) with validated commercial probes.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355265|NCT01732107|Other Pre-specified|Characterize Pre- and Post-treatment VEGFR Pathway Phosphorylation Changes as Assessed by Bladder Tumor Tissue Immunohistochemistry.|Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355266|NCT01732107|Other Pre-specified|Characterize Associations Between Pre-treatment Germline, FGFR Single-nucleotide Polymorphisms (SNPs) and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.|Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355267|NCT01732107|Other Pre-specified|Characterize Pre- and Post-treatment Bladder Tumor FGFR Pathway Phosphorylation Changes.|Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355268|NCT01732107|Secondary|Characterize Treatment-related Toxicity Rates|Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.|12 months||||participants|||Number
1355269|NCT01732107|Secondary|Determine 3-Month and 6-Month Partial Response Rates|The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).|6 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355270|NCT01732107|Secondary|Determine Rate of Progression to Muscle-Invasive Stage|The rate of progression to muscle-invasive stage for dovitinib is defined as the proportion of patients with clinical or pathologic progression to muscle-invasive stages (i.e., T2-T4) at any time point on study.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355271|NCT01732107|Secondary|Determine 1-Year Relapse-Free Survival Rate|The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
1355272|NCT01732107|Primary|Determine 6-Month Complete Response Rate|The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.|6 months||||percentage of participants|||Number
1355273|NCT01731990|Secondary|High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline|Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis.|||Ratio||Standard Error|Least Squares Mean
1355274|NCT01731990|Secondary|Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline|Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis.|||Ratio||Standard Error|Least Squares Mean
1355275|NCT01731990|Secondary|Number of Patients With Adverse Events in 12 Months|Summary statistics on adverse event is reported. It is categorized as number of patients in total adverse events (non serious and serious AEs), serious adverse event, death.|Baseline to 12 months post-dose|All patients that received any study drug were included in the safety analysis set.|||Participants|||Count of Participants
1355293|NCT01730846|Primary|Latency (Min) to Initiate Ad-lib Smoking Session|Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.|0 up to 50 minutes (Delay Period)||||minutes||Standard Error|Mean
1355516|NCT01729026|Secondary|MINI International Neuropsychiatric Inventory (MINI)|Semi-structured interview used to assess the presence of 15 common DSM-IV psychiatric diagnoses.|Baseline|||||||
1355276|NCT01731990|Primary|Mean Vessel Wall Area Ratio of 12 Months to Baseline|Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients who underwent iliac/femoral stenting were removed from all data points that occurred after this procedure in the analysis.|||Ratio||Standard Error|Least Squares Mean
1355277|NCT01731938|Secondary|Treatments Failures|"The following were considered treatment failures:~Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator’s judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure."|From start of treatment to time of completion of surgical closure.||||percentage of subjects|||Number
1355278|NCT01731938|Secondary|Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.||From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment||||percentage of subjects|||Number
1355279|NCT01731938|Secondary|Time to Hemostasis (TTH)|TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.|From start of treatment to the end of the 10-minute observational period||||minutes||Standard Error|Mean
1355280|NCT01731938|Primary|Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start||||percentage of participants|||Number
1355281|NCT01731470|Secondary|Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)|Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.|4 and 8 weeks post-treatment||||units on a scale||Inter-Quartile Range|Mean
1355282|NCT01731470|Primary|Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score|The O’Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.|4 and 8 weeks post-treatment||||units on a scale||Inter-Quartile Range|Median
1355283|NCT01731119|Secondary|Overall Clinical Improvement|Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1355284|NCT01731119|Secondary|Number of Participants Experiencing Side Effects|Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.|Baseline to12 weeks||||Participants|||Count of Participants
1355285|NCT01731119|Secondary|Changes in Efficacy Measures|Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.|Baseline to 12 weeks||||units on a scale||95% Confidence Interval|Mean
1355286|NCT01731119|Secondary|Proportion of Participants Completing Treatment|Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.|12 weeks||||Participants|||Count of Participants
1355287|NCT01731119|Primary|Change in Weight|Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.|Baseline to 12 weeks||||lbs||95% Confidence Interval|Mean
1355288|NCT01731041|Secondary|P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12|Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.|4 hours||||PRU||Standard Error|Least Squares Mean
1355289|NCT01731041|Primary|Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment|4 hours||||PRI%||Standard Error|Least Squares Mean
1355290|NCT01731002|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups.|28 Days||||days||Standard Deviation|Mean
1355291|NCT01731002|Primary|Intraocular Pressure (IOP)|The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.|Study treatment was administered for 28 days|Modified intent to treat (mITT) population (3 subjects were excluded, leaving 221)|||mmHg||Standard Deviation|Mean
1355292|NCT01730846|Secondary|Number of Cigarettes Smoked During Ad-lib Session|"Number of cigarettes smoked during the stress and neutral ad-lib smoking period.~Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish."|60 minutes (ad-lib smoking period)||||number of cigarettes||Standard Error|Mean
1355294|NCT01730378|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (From Day 0 to 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1355295|NCT01730378|Secondary|Number of Subjects Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1355296|NCT01730378|Secondary|Number of Subjects Reporting Unsolicted AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 84-day (Days 0-83) post vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1355297|NCT01730378|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21 days (Day 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1355298|NCT01730378|Secondary|Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).|Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (From Day 0 to Day 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1355299|NCT01730378|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C|During the 7-day (Days 0-6) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1355300|NCT01730378|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Day 0-6) period after each vaccination|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1355301|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1355302|NCT01730378|Secondary|Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1355303|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1355517|NCT01729026|Secondary|Community Integration Questionnaire (CIQ)|Self-rating scale that assesses the extent of a subject's integration into her or his community|Baseline and 3-month and 6-month follow-up visits|||||||
1355304|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Days 0 and 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1355305|NCT01730378|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1355306|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1355307|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1355308|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1355309|NCT01730378|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1355310|NCT01730378|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1355311|NCT01730378|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1355312|NCT01730378|Primary|Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 42|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subjects|||Number
1355313|NCT01730339|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.|||participants|||Number
1355314|NCT01730339|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest|Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.|Baseline up to Week 24|"Safety population included all participants who received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||participants|||Number
1355315|NCT01730339|Other Pre-specified|Number of Participants With Electrocardiogram Findings|Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.|Baseline, Week 11|"Safety population included all participants who received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."|||participants|||Number
1355316|NCT01730339|Other Pre-specified|Number of Participants With Abnormal Physical Examinations|Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.|||participants|||Number
1355317|NCT01730339|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.|||participants|||Number
1355318|NCT01730339|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
1355319|NCT01730339|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
1355320|NCT01730339|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
1355321|NCT01730339|Secondary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
1355322|NCT01730339|Primary|Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)|Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant’s scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 24|Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||units on scale||Standard Error|Least Squares Mean
1355323|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1355324|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Fasting triglycerides ITT population.|||percent change||Standard Error|Mean
1355325|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1355326|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Lipoprotein (a) ITT population.|||percent change||Standard Error|Mean
1355327|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355328|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
1355329|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355330|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
1355331|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
1355332|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
1355333|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
1355334|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
1355335|NCT01730053|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1355336|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1355337|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1355338|NCT01730053|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355339|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1355340|NCT01730053|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355475|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355341|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.|||percent change||Standard Error|Least Squares Mean
1355342|NCT01730053|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355343|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
1355344|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1355345|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1355346|NCT01730053|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355347|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1355348|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1355349|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1355350|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Lipoprotein (a) ITT population.|||percent change||Standard Error|Mean
1355351|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355352|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.|||percent change||Standard Error|Mean
1355353|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355354|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
1355518|NCT01729026|Secondary|Beck Depression Inventory - II (BDI-II)|Self-rating scale that assesses the frequency and severity of common symptoms of depression|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
1355519|NCT01729026|Secondary|Alcohol Use Disorders Identification Test (AUDIT-C)|Self-rating scale that assesses the frequency and extent of alcohol use|Baseline and 1-month, 3-month, 4-month, and 6-month follow-ups|||||||
1355355|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
1355356|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
1355357|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
1355358|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
1355359|NCT01730040|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1355360|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1355361|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1355362|NCT01730040|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355363|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1355364|NCT01730040|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355365|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.|||percent change||Standard Error|Least Squares Mean
1355366|NCT01730040|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355367|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
1355368|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1355520|NCT01729026|Secondary|Clinician-Administered PTSD Scale for DSM-5 (CAPS)|The administration of the CAPS will ensure that participants meet criteria for current PTSD|The CAPS will be administered at the baseline, 3-month, and 6-month follow-ups.|||||||
1355369|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1355370|NCT01730040|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1355371|NCT01729923|Secondary|Relapse Free Survival in Patients Achieving CR|Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.|Up to 5 years|Measure Description: Inclusive of subject still alive at time of last reporting Time Frame: Until last reported survival Study terminated; data not further analyzed|||months|||Number
1355372|NCT01729923|Secondary|Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)|Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.|Up to 5 years|We have been unable to confirmation that the original Principal Investigator secured the appropriate permission to use this instrument. Therefore, we are unable to use the data.||||||
1355373|NCT01729923|Secondary|Overall Survival|Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival.|Until death or last reported survival, up to 5 years||||months||Full Range|Median
1355374|NCT01729923|Secondary|K-ras Mutation Status|The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.|Up to 5 years|K-ras mutation status was not collected.||||||
1355375|NCT01729923|Secondary|Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy|RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.|Serial measures at 9 week intervals up to 5 years|Patients who had RECIST measurements at baseline and at least one subsequent occasion and did not have surgery or radiation therapy|||percentage of baseline lesion size||Full Range|Mean
1355376|NCT01729923|Secondary|Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion|RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.|Serial measures at 9 week intervals up to 5 years|All patients who had RECIST measures at baseline and at least one other time point.|||percentage of baseline lesion size||Full Range|Mean
1355377|NCT01729923|Primary|Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1|Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy.|3 years||||Participants|||Count of Participants
1355378|NCT01729871|Secondary|Number of Participants With Vascular Death|Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
1355379|NCT01729871|Secondary|Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism|The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
1355380|NCT01729871|Secondary|Number of Participants With Ischemic Stroke|Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
1355381|NCT01729871|Secondary|Number of Participants With Myocardial Infarction (MI)|The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site’s upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
1355382|NCT01729871|Secondary|Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death|The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
1355383|NCT01729871|Primary|Number of Participants With Incidence of Post-Procedure Major Bleeding Events|Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
1355384|NCT01729845|Secondary|Overall Survival|Survival measured as of day of last contact. Categorized according to criteria recommended by International Working Groups.|Up to 5 years|Population includes all Dose Level 2 participants, from both periods 1 and 2.|||days||Full Range|Median
1355385|NCT01729845|Secondary|Duration of Relapse-free Survival (for Patients Achieving CR or CRp)|Categorized according to criteria recommended by International Working Groups.|Up to 5 years|Population includes all Dose Level 2 participants, from both periods 1 and 2, who achieved CR or CRp|||Days||Full Range|Median
1355386|NCT01729845|Secondary|Remission Rate Including CR and CRp|"Complete remission (CR) and Complete remission with incomplete platelet recovery (CRp) categorized according to criteria recommended by International Working Groups:~Complete resolution of disease-related symptoms and signs including palpable hepatosplenomegaly; hemoglobin level at least 110 g/L, platelet count at least 100x10^9/L, and absolute neutrophil count at least 1.0 x10^9/L. In addition, all 3 blood counts should be no higher than the upper normal limit; Normal leukocyte differential; Bone marrow histologic remission defined as the presence of age-adjusted normocellularity, no more than 5% myeloblasts, and an osteomyelofibrosis grade no higher than 1."|Up to 5 years|Population includes all Dose Level 2 participants from both periods 1 and 2.|||Participants|||Count of Participants
1355387|NCT01729845|Primary|Most Efficacious and Tolerated Dosage of Decitabine (Period 1)|MTD (most tolerated dose) of decitabine, measured in number of dose limiting toxicities. MTD defined as the highest dose in which the incidence of dose limiting toxicity is < 33%, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)|through day 45||||Incidents|||Number
1355388|NCT01729819|Secondary|Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline|An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Score on scale||95% Confidence Interval|Least Squares Mean
1355389|NCT01729819|Secondary|Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment|A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Number of voids||95% Confidence Interval|Least Squares Mean
1355390|NCT01729819|Secondary|Responder Status|Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Odds of responder status|||Number
1355391|NCT01729819|Secondary|Change in Mean Nocturnal Urine Volume From Baseline|The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||mL||95% Confidence Interval|Least Squares Mean
1355392|NCT01729819|Secondary|Change in Mean Time to First Nocturnal Void From Baseline|The time to first nocturnal void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Minutes||95% Confidence Interval|Least Squares Mean
1355393|NCT01729819|Primary|Change in Mean Number of Nocturnal Voids From Baseline|A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Number of voids||95% Confidence Interval|Least Squares Mean
1355521|NCT01729026|Primary|Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up|PCL-5 a self rating scale based on the DSM-5 diagnostic criteria. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).|Baseline and 3-month follow-up visit.||||units on a scale||Standard Error|Mean
1355394|NCT01729754|Secondary|Mean Percent Change From Baseline in PASI Score Over Time (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52|Analysis population includes randomized participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 32, 36, 40, 46 and 52).|||Percent change||Standard Deviation|Mean
1355395|NCT01729754|Secondary|Mean Percent Change From Baseline in PASI Score Over Time (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 16, Week 22 or Week 28|Analysis population includes randomized participants who received at least one dose of study medication in Part 2 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 16, 22 and 28).|||Percent change||Standard Deviation|Mean
1355396|NCT01729754|Secondary|Mean Percent Change From Baseline in PASI Score Over Time (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 4, Week 8 or Week 12|Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 4, 8 and 12).|||Percent change||Standard Deviation|Mean
1355397|NCT01729754|Secondary|Mean Change From Baseline in PASI Score Over Time (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52|Analysis population includes randomized participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 32, 36, 40, 46 and 52).|||Scores on a scale||Standard Deviation|Mean
1355398|NCT01729754|Secondary|Mean Change From Baseline in PASI Score Over Time (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 16, Week 22 or Week 28|Analysis population includes randomized participants who received at least one dose of study medication in Part 2 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 16, 22 and 28).|||Scores on a scale||Standard Deviation|Mean
1355399|NCT01729754|Secondary|Mean Change From Baseline in PASI Score Over Time (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 4, Week 8 or Week 12|Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 4, 8 and 12).|||Scores on a scale||Standard Deviation|Mean
1355400|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 52.|||Percentage of participants|||Number
1355401|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 40.|||Percentage of participants|||Number
1355402|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Week 28|Analysis population includes randomized participants to tildrakizumab 200 mg, tildrakizumab 100 mg or etanercept in Part 1, who received at least one dose of study medication in Part 2 and with a valid DLQI value at Week 28.|||Percentage of participants|||Number
1355403|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Week 12|Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with a valid DLQI value at Week 12.|||Percentage of participants|||Number
1355522|NCT01728792|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 28, 90 and 120 after 1st vaccination|Protocol deviations results in testing not performed for outcome measure.||||||
1355404|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 52 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 52|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 52.|||Score on a scale||Standard Deviation|Mean
1355405|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 40 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 40|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 40.|||Score on a scale||Standard Deviation|Mean
1355406|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 28 (Part 2)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline and Week 28|Analysis population includes randomized participants who received at least one dose of study medication and with baseline or post-baseline DLQI values in Part 1 or Part 2.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1355407|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 12 (Part 1)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline and Week 12|Analysis population includes randomized participants who received at least one dose of study medication with baseline or post-baseline DLQI values in Part 1.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1355408|NCT01729754|Secondary|Baseline Dermatology Life Quality Index (DLQI)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline|Analysis population includes randomized participants who received at least one dose of study medication with baseline and post-baseline DLQI values in Part 1.|||Score on a scale||Standard Deviation|Mean
1355409|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.|||Percentage of participants|||Number
1355410|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.|||Percentage of participants|||Number
1355411|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.|Week 28|Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in study Part 2.|||Percentage of participants|||Number
1355412|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.|Week 12|Analysis population includes randomized participants who received at least one dose of study medication in study Part 1 and with valid PASI value at baseline and Week 12.|||Perentage of participants|||Number
1355413|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.|||Percentage of participants|||Number
1355414|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.|||Percentage of participants|||Number
1355415|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.|Week 28|Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in study Part 2.|||Percentage of participants|||Number
1355416|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.|Week 12|Analysis population includes randomized participants who received at least one dose of study medication in study Part 1.|||Percentage of participants|||Number
1355417|NCT01729754|Secondary|Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)|The PGA is used to determine the overall severity of a participant’s psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52.|||Percentage of participants|||Number
1355418|NCT01729754|Secondary|Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)|The PGA is used to determine the overall severity of a participant’s psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40.|||Percentage of participants|||Number
1355419|NCT01729754|Secondary|Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)|The PGA is used to determine the overall severity of a participant’s psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Week 28|Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in Part 2.|||Percentage of participants|||Number
1355420|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.|||Percentage of participants|||Number
1355421|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.|||Percentage of participants|||Number
1355422|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.|Week 28|Analysis population includes all participants randomized to tildrakizumab or etanercept in Part 1 who received at least one dose of study medication in Part 2.|||Percentage of participants|||Number
1355423|NCT01729754|Primary|Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (Extension)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 212 weeks||2019-07-31|07/2019||||
1355424|NCT01729754|Primary|Percentage of Participants Experiencing an Adverse Event (Extension)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 212 weeks||2019-07-31|07/2019||||
1355425|NCT01729754|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received.|||Percentage of participants|||Number
1355426|NCT01729754|Primary|Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received.|||Percentage of participants|||Number
1355427|NCT01729754|Primary|Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)|The PGA is used to determine the overall severity of a participant’s psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.|Week 12|Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.|||Percentage of participants|||Number
1355428|NCT01729754|Primary|Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.|Week 12|Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.|||Percentage of participants|||Number
1355429|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity|A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children N=27 at Visit 1 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at visit)."|||U/L||Standard Deviation|Mean
1355430|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity|The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 3: N=16 one participant with missing data at this visit)."|||U/L||Standard Deviation|Mean
1355431|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity|The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visit 1: N=27 (1 participant missing); Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at this visit)."|||U/L||Standard Deviation|Mean
1355432|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Protein Concentration|The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||g/L||Standard Deviation|Mean
1355433|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity|Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visits 1 and 3: N=26 and at Visit 2 N=24 participants; Young and Very Young Children Group at Visits 1 and 3: N=16 participant with missing data)."|||U/L||Standard Deviation|Mean
1355434|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration|Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents-Visit 2 & 3: N=20 - 1 participant with data missing; Older Children-Visit 1 & 2: N=26 thus 2 participants with data missing; Young and Very Young Children-Visits 1 & 3: N=12 (5 with data missing) & at Visit 2 N=9 (8 with data missing)."|||µmol/L||Standard Deviation|Mean
1355435|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity|The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 2: N=16 one participant with missing data)."|||U/L||Standard Deviation|Mean
1355436|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity|This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=19 two participants with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||U/L||Standard Deviation|Mean
1355437|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test|A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."|||units on a scale||Standard Deviation|Mean
1355438|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine Specific Gravity|This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."|||units on a scale||Standard Deviation|Mean
1355439|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate|Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mL/min/1.73m^2||Standard Deviation|Mean
1355440|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urate in the Blood|Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||µmol/L||Standard Deviation|Mean
1355441|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration|Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children N=27 at Visit 1; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||g/L||Standard Deviation|Mean
1355442|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triglycerides Concentration|Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant data missing; Older children Visits 2 and 3: N=27 and N=26 one and two participant data missing; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant data missing)."|||mmol/L||Standard Deviation|Mean
1355443|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity|AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visits 2 and 3: N=26 two participants with missing data; Young and Very Young Children Group at Visits 1 and 3: N=16 one participant with missing data)."|||U/L||Standard Deviation|Mean
1355444|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatinine Concentration|Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||µmol/L||Standard Deviation|Mean
1355445|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration|This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
1355446|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration|Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
1355447|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration|Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
1355773|NCT01725984|Primary|Number of Adverse Events Reported Between Arms|Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events|Prospective follow-up to 36 Months Post Procedure||||Adverse Events|||Number
1355448|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration|All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
1355449|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration|Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
1355450|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration|Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
1355451|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration|A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
1355452|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Leukocyte Concentration|Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each visit)."|||GI/L||Standard Deviation|Mean
1355453|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Platelet Count|Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||GI/L||Standard Deviation|Mean
1355454|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)|Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||fL||Standard Deviation|Mean
1355455|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||fraction of blood volume||Standard Deviation|Mean
1355476|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355456|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hemoglobin Concentration|The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||g/L||Standard Deviation|Mean
1355457|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||hours||Standard Deviation|Mean
1355458|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||nanogramsg/millilitre||Standard Error|Mean
1355459|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||ng*hr/mL||Full Range|Mean
1355460|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||hours||Standard Deviation|Mean
1355461|NCT01729728|Secondary|Intake of Additional Analgesic Medication During the Trial|Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).|Baseline; 15 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.|||participants|||Number
1355462|NCT01729728|Secondary|Treatment Emergent Adverse Events by Intensity|"The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.~The clinical “intensity” of an adverse event was classified as:~Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.~Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.~Severe: Symptoms which affect usual daily activity.~For adverse events where the intensity changes over time, the maximum intensity observed was documented."|Baseline; 48 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.|||number of events|||Number
1355463|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample"|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||nanograms/millilitre||Standard Error|Mean
1355464|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter|"12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.~The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.~A positive value indicates that the heart rate was higher at discharge than at enrollment."|Enrollment; Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(For older children: N=27 at Visit 1)"|||beats per minute||Standard Deviation|Mean
1355465|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Parameters|"12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.~The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities."|Enrollment (pre-surgery); Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(For older children N=27 at Visit 1)"|||milliseconds||Standard Deviation|Mean
1355466|NCT01729728|Secondary|Systolic and Diastolic Blood Pressure Assessments|"Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."|||mmHg||Standard Deviation|Mean
1355467|NCT01729728|Secondary|Oxygen Saturation Assessments|"Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."|||percentage of oxygen saturation||Standard Deviation|Mean
1355468|NCT01729728|Secondary|Respiratory Rate Assessments|"Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, and at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."|||breaths per minute||Standard Deviation|Mean
1355469|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.~The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.~The area is that below the line fitted to the data points."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||ng*hr/mL||Full Range|Mean
1355470|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355471|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355472|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355473|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355474|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355497|NCT01729338|Secondary|Severe Adverse Event Rate|Defined as number of patients experiencing any grade or severe (≥ grade 3 by common toxicity criteria for adverse events (CTCAE) v4.0 criteria) adverse events at any time during the study|Up to 3 years||||percentage of participants|||Number
1355477|NCT01729728|Secondary|Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups|"Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.~Adolescents - Age 12 to Less Than 18 Years.~Older Children - Age 6 to Less Than 12 Years.~Young Children - Age 3 to Less Than 6 Years.~Very Young Children - Age 2 to Less Than 3 Years.~CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],~VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],~FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],~FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].~A mean score of zero indicates that there was no pain intensity change over the 4 hours.~The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period."|Baseline; 4 hours post-dose|Protocol pre-specified reporting groups.|||units on a scale||Standard Deviation|Mean
1355478|NCT01729728|Secondary|Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).|The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.|Baseline; 15 hours post-dose|The protocol pre-specified that the young and very young children will be reported as one group.|||units on a scale||Standard Deviation|Mean
1355479|NCT01729728|Secondary|Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.|"This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.~The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.~The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician."|Baseline; 15 hours post-dose|The protocol pre-specified that the Faces Pain Scale (Revised) would not be administered in the very young participants (aged 2 to less than 3 years).|||units on a scale||Standard Deviation|Mean
1355480|NCT01729728|Secondary|Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).|Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.|Baseline; 15 hours post-dose|Protocol pre-specified reporting groups.|||units on a scale||Standard Deviation|Mean
1355481|NCT01729728|Secondary|Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).|"At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:~“My pain at this time is”. The mark was scored between “no pain” and ” pain as bad as it could be”. The distance was then measured by a clinician and reported.~A value of 0 indicates no pain. A value of 100 indicates pain as bad as it could be."|Baseline; 15 hours|Protocol pre-specified reporting groups.|||units on a scale||Standard Deviation|Mean
1355482|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
1355483|NCT01729559|Secondary|Heparin Induced Thrombocytopenia|The possible occurrence of heparin induced thrombocytopenia (HIT) was investigated when any patient (in either low molecular weight heparin [LMWH] or low dose unfractionated heparin [LDUH] study arm) had a platelet count drop of ≥50% (from a baseline value at the time of initiation of VTE prophylaxis) between day 5 and 14 following initiation of chemoprophylaxis per American College of Chest Physicians (ACCP) guidelines.|Within 30 of admission to hospital||||participants|||Number
1355484|NCT01729559|Secondary|Bleeding Event|Bleeding events will be classified by the Graafsma et al. severity of bleeding criteria (Major, Minor or No Bleeding). A major bleeding event will be defined as any overt bleeding following initiation of chemoprophylaxis associated with one or more of the following; a decrease in hemoglobin of ≥2 g/dL, bleeding leading to a transfusion of ≥2 units of packed red blood cells, a new retroperitoneal or intracranial bleed, or bleeding that warranted cessation of chemoprophylaxis treatment. Minor bleeding is defined as clinically evident bleeding not meeting criteria for major bleeding.|Within 30 days of admission to hospital||||participants|||Number
1355485|NCT01729559|Primary|Pulmonary Embolus|Patients with any or all of the following signs and symptoms suggestive of pulmonary embolism will have a CT angiogram (CTA) performed for diagnosis: Sudden onset of dyspnea, deterioration of existing dyspnea, decreased oxygen saturation (<92%), onset of pleuritic chest pain without another apparent cause, onset of tachycardia (>100), evidence of hypoxemia, hypocapnia, or respiratory alkalosis on arterial blood gas, or electrocardiographic changes reflecting right ventricular strain.|Within 30 days from admission to hospital||||participants|||Number
1355512|NCT01729026|Secondary|Semi-Structured Interview|Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls|||||||
1355486|NCT01729559|Primary|Lower Extremity Deep Vein Thrombosis|Patients will have a bilateral lower extremity duplex ultrasound performed by a registered vascular technologist twice per week if the patient is in the ICU, or once per week if the patient is on the trauma ward. All of the deep veins from the external iliac to and including the calf veins will be interrogated. Diagnosis of deep vein thrombosis (DVT) will be defined as absence of complete vein compressibility, presence of an echogenic thrombus within the vein, absence of color flow characteristics including lack of spontaneity, phasicity, pulsatility and augmentability as noted in the clinical practice guidelines of the American Thoracic Society. The vascular technologist and physician reading the ultrasound study will be blinded to the patient's enrollment status and randomization arm/medication group.|Within 30 days of hospital admission||||percentage of patients|||Number
1355487|NCT01729338|Secondary|Risk Score as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool|Calculation of the risk score requires that the patient be assessed with the CALGB Assessment Tool, which has both a patient self-reporting questionnaire and a clinician assessment. Both will be used in this trial, and thus patients will have risk scores based on their own self-assessments and risk scores based on the clinicians’ assessment. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk. The distribution of the risk score in this trial will be described by plotting the median of the risk score against time, with patient and clinician assessments overlaid on the same plot.|Day 1|Data for the risk score wasn’t recorded correctly, and therefore we were unable to analyze the data.||||||
1355488|NCT01729338|Secondary|Functionality as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool|"Mean functionality in study subjects, quantitatively scored using the standardized and validated Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool, which comprehensively assesses aspects of a patient's functionality such as symptoms (e.g., pain, anxiety), social support (e.g., someone to turn to for help), and ability to carry out routine activities (e.g., grocery shopping) or physical exertion (e.g., climbing stairs) was assessed at baseline.~The score is obtained by inserting patient-specific data into the online calculator found at http://www.mycarg.org/Chemo_Toxicity_Calculator, which is based on the risk score described in Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011;29(25):3457-3465.~The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk for severe (grade >2) toxicity."|baseline|Participants who completed functionality assessment at baseline. Data were incompletely and irregularly collected after baseline so unable to analyze additional time points.|||Scores on a scale||Standard Deviation|Mean
1355489|NCT01729338|Secondary|QLQ-C30 Question 30|"Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week?~7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality."|baseline, 3 months, 5 months|Participants who completed questionnaire.|||units on a scale||Standard Deviation|Mean
1355490|NCT01729338|Secondary|QLQ-C30 Question 29|Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 29: how would you rate your overall health during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.|baseline, 3 months, 5 months|Participants who completed questionnaire.|||units on a scale||Standard Deviation|Mean
1355491|NCT01729338|Secondary|Median Overall Survival|Defined as median time elapsed in study subjects between initiation of study therapy and death, regardless of cause.|Up to 3 years||||months||Standard Deviation|Median
1355492|NCT01729338|Secondary|Median Progression-free Survival|Defined as median time elapsed in study subjects between initiation of study therapy and either disease progression or death, regardless of cause of death.|4 years||||months||Standard Deviation|Median
1355493|NCT01729338|Secondary|Median Duration of Response|Defined as median time elapsed in study subjects between achievement of response and disease progression.|From date of first confirmed response until date of disease progression or up to 3 years|9 out of all patients achieved response and hence could be analyzed for duration of response|||months||Standard Deviation|Median
1355494|NCT01729338|Secondary|Median Time to Response|Defined as median time to achievement of response (partial remission or better by International Myeloma Working Group standard criteria), in study subjects during 8 months of induction chemotherapy.|Up to 8 months||||months||Standard Deviation|Median
1355495|NCT01729338|Secondary|Maximum Depth of Response During Maintenance Therapy|"Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy.~IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease."|Up to 3 years|8 of all subjects reached maintenance and could be analyzed|||percentage of participants|||Number
1355496|NCT01729338|Secondary|Maximum Depth of Response During Induction Therapy|Maximum depth of response is defined as: ranging from partial response to complete response by International Myeloma Working Group (IMWG). Described as number of patients achieving each level of response. IMWG: CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease.|Up to 8 months||||percentage of participants|||Number
1355498|NCT01729338|Primary|Overall Response Rate (ORR) During Induction Therapy|"Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria:~IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour."|Up to 8 months||||percentage of participants|||Number
1355499|NCT01729247|Secondary|Asthma Management Changes After FeNO Results Were Considered|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).|Study visit (single visit study). Approximately1 hour.||||participants|||Number
1355500|NCT01729247|Secondary|Number of Participants Correctly Categorized by True Level of Airway Inflammation|Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.|Study visit (single visit study) approximately 1 hour.||||participants correctly categorized|||Number
1355501|NCT01729247|Secondary|Physician Assessment of Airway Inflammation|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).|Study visit (single visit study) approximately 1 hour||||parts per billion (ppb)||Standard Deviation|Mean
1355502|NCT01729247|Primary|FeNO Categorical Levels by ICS Use|Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (<25 ppb), intermediate (>=25 to <=50 ppb) and high (>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.|Study visit (single visit study). Approximately1 hour.||||participants|||Number
1355503|NCT01729247|Primary|FeNO Values by ACT Score|Scores on an asthma control test (ACT) of <=19 indicates less well controlled asthma, scores >19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.|Study Visit (single visit study). Approximately 1 hour.||||parts per billion (ppb)||Standard Deviation|Mean
1355504|NCT01729039|Secondary|10 Meter Walk Test|This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.|6 weeks||||ft/s||Standard Deviation|Mean
1355505|NCT01729039|Secondary|Activities-specific Balance Confidence Scale|As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.|6 weeks||||percentage||Standard Deviation|Mean
1355506|NCT01729039|Secondary|Dynamic Gait Index|The dynamic gait index (DGI) assesses an individual’s ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of < 20 indicate high risk for falling.|6 weeks||||units on a scale||Standard Deviation|Mean
1355507|NCT01729039|Primary|Visual Analog Scale - Disequilibrium|This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.|6 weeks|Repeated Measure (RM) ANOVA|||units on a scale||Standard Deviation|Mean
1355508|NCT01729039|Primary|Visual Analog Scale - Head Movement|This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.|6 weeks||||units on a scale||Standard Deviation|Mean
1355509|NCT01729026|Secondary|Numeric Rating Scale for Pain Intensity|Self-rating scale that assesses pain severity|Baseline and 3-month and 6-month follow-up|||||||
1355510|NCT01729026|Secondary|Veterans RAND 12-item Health Survey (VR-12)|Self-rating scale that assess physical and mental aspects of health-related quality of life|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
1355511|NCT01729026|Secondary|UCLA Loneliness Scale, Version 3|Self-rating scale to assess symptoms of loneliness|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
1355523|NCT01728792|Secondary|Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations|"Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. n in each of the categories is the number of participants with data available."|Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.|||participants|||Number
1355524|NCT01728792|Primary|Seroconversion Rate to Each of Four Dengue Serotypes|Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)|Protocol deviations results in testing not performed for outcome measure.||||||
1355525|NCT01728792|Primary|Number of Participants With at Least 1 Serious Adverse Event During the Study|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|First Vaccination to End of Study (Up to Day 120)|Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
1355526|NCT01728792|Primary|Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
1355527|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity|Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
1355528|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity|Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
1355529|NCT01728792|Primary|Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator|Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
1355530|NCT01728584|Secondary|Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm|Post operative use of pain/analgesic medication by participant through Day 8 was recorded.|Up to Day 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||participants using pain medication|||Number
1356021|NCT01722266|Primary|Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks|The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.|12 Weeks||||mg/dl||Standard Error|Mean
1355531|NCT01728584|Secondary|Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||Standard Deviation|Mean
1355532|NCT01728584|Secondary|Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||Standard Deviation|Mean
1355533|NCT01728584|Secondary|Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||Standard Deviation|Mean
1355534|NCT01728584|Secondary|Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm|During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a “rescue intervention”), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||participants|||Number
1355535|NCT01728584|Secondary|Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): How did the patient movements described above disrupt your surgical performance? This refers to participant movements during surgery."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
1355536|NCT01728584|Secondary|Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)|At the end of the procedure the surgeon responds to the following question: “How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?”|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||instances of occurrence that interfered||95% Confidence Interval|Least Squares Mean
1355537|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
1355538|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
1355539|NCT01728584|Secondary|Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): How satisfied were you overall with the visual field during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
1355540|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant’s overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||95% Confidence Interval|Least Squares Mean
1355541|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant’s overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||95% Confidence Interval|Least Squares Mean
1355542|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a acale||95% Confidence Interval|Least Squares Mean
1355543|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
1355544|NCT01728376|Secondary|Maximum Plasma Concentration (Cmax) of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at end of infusion|Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.|||µg/mL||Standard Deviation|Mean
1355545|NCT01728376|Secondary|Trough Plasma Concentration of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day’s end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at pre-dose|Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.|||µg/mL||Standard Deviation|Mean
1355602|NCT01727791|Primary|Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)|Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
1355546|NCT01728376|Secondary|Percentage of Participants With Overall Success at TOC Visit|Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.|||Percentage of participants|||Number
1355547|NCT01728376|Secondary|Percentage of Participants With Clinical Success at TOC/Safety Visit|Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.|||Percentage of participants|||Number
1355548|NCT01728376|Primary|Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)|Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.|TOC Safety Visit (up to 56 days)|Participants who received any dose of IV study medication.|||Participants|||Number
1355549|NCT01728376|Primary|Percentage of Participants With Sustained CPK Elevations|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)|Baseline up to end of therapy visit (up to 44 days)|Participants who received any dose of IV study medication|||Percentage of Participants|||Number
1355550|NCT01728376|Primary|Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .|Baseline up to end of therapy visit (up to 49 days)|Participants who received any dose of IV study medication|||Percentage of Participants|||Number
1355551|NCT01728376|Primary|Number of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication|||Participants|||Number
1355552|NCT01728376|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication|||Participants|||Number
1355553|NCT01728337|Secondary|Maximum Evoked Compound Muscle Action Potential|To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.|5 months after the procedure.|All subjects have received both treatments.|||mV||Standard Deviation|Mean
1355554|NCT01728337|Primary|Percentage of Responders After 5 Months After the Procedure|Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score at maximum contraction compared to the WSS score at baseline.|5 months after intervention|80 sujbects were included in this study, each patient have received both products in their faces. The randomization was performed to define the side for each product.|||percentage of participants|||Number
1355555|NCT01728324|Secondary|Prognostic Value of SVR12 Predicting SVR24|The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.|24 Week (post-treatment)|FAS|||Percentage of participants|||Number
1355556|NCT01728324|Secondary|SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.|4 weeks (after End Of Treatment)|FAS|||percentage of participants||95% Confidence Interval|Number
1355557|NCT01728324|Secondary|SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.|4 weeks (after End Of Treatment)|FAS|||percentage of participants||95% Confidence Interval|Number
1355558|NCT01728324|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS|||Percentage of participants||95% Confidence Interval|Number
1355603|NCT01727791|Primary|Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)|Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg||Geometric Coefficient of Variation|Geometric Mean
1355559|NCT01728324|Primary|SVR12 Rates With Historical Control|"Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.~The number of participants analyzed are actually adjusted number of participant analyzed."|12 Week (post-treatment)|Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;|||percentage of participants|||Number
1355560|NCT01728246|Primary|Time to Discontinuation Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|Time to discontinuation because of rescue medication was not analyzed, because dates when the rescue medication was given were not properly filled out in the forms, hence the exact time to discontinuation because of rescue medication could not be determined or analyzed.||||||
1355561|NCT01728246|Primary|Percentage of Participants Who Discontinued Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.|||percentage of participants|||Number
1355562|NCT01728246|Primary|Change From Baseline in ODI Score at Week 4|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 4 (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1355563|NCT01728246|Primary|Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 2|Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score.||||||
1355564|NCT01728246|Primary|Change From Baseline in VAS-pain Score at Week 4|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 4 Last Observation Carried Forward (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.|||mm||Standard Deviation|Mean
1355565|NCT01728246|Primary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2|VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 2|Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.|||mm||Standard Deviation|Mean
1355566|NCT01728116|Secondary|Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months||Baseline and 12 Months|mITT population without imputation|||percentage of participants|||Number
1355567|NCT01728116|Secondary|Diastolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mmHg||Standard Deviation|Mean
1355568|NCT01728116|Secondary|Systolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mmHg||Standard Deviation|Mean
1355569|NCT01728116|Secondary|Fasting Glucose Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mg/dL||Standard Deviation|Mean
1355570|NCT01728116|Secondary|Triglycerides Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mg/dL||Standard Deviation|Mean
1355571|NCT01728116|Secondary|LDL Change From Baseline||Baseline and 12 Months|mITT without imputation|||mg/dL||Standard Deviation|Mean
1355572|NCT01728116|Secondary|Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months||Baseline and 12 Months|mITT population without imputation|||percentage of participants|||Number
1355573|NCT01728116|Secondary|Assessment of Total Cholesterol Change at 12 Months Compared to Baseline||Baseline and 12 Months|mITT population without imputation|||mg/dL||Standard Deviation|Mean
1355574|NCT01728116|Primary|Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE|Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.|Baseline and 12 Months|mITT without Imputation|||percentage of participants||95% Confidence Interval|Number
1355575|NCT01728116|Primary|Primary Efficacy Endpoint: Improvement in HbA1c|Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation|Baseline and12 months|All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.|||Percentage of HbA1c||Standard Deviation|Mean
1355576|NCT01728077|Secondary|50 % Responder Rate in Partial-Onset-Seizure (POS) Type I Frequency From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected|The POS frequency is standardized to a 28-day duration. A responder is defined as a subject with a >=50% reduction in seizure frequency from the Baseline Period of the previous study. Results are presented as the percentage of subjects with 50 % responder rate in POS Type I frequency.|From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.|||percentage of subjects|||Number
1355577|NCT01728077|Secondary|Percentage of Change in Partial-Onset-Seizure (POS) Type I Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected|The POS frequency is standardized to a 28-day duration. Results are presented as the median percentage of reduction per 28 days. Negative values indicate improvement from Baseline.|From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.|||percentage of change||Full Range|Median
1355578|NCT01728077|Secondary|Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy|The POS frequency is standardized to a 28-day duration. Results are presented as the median number of seizures per 28 days.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.|||Seizures per 28 days||Full Range|Median
1355579|NCT01728077|Primary|Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defects. Results are presented as the percentage of subjects with at least one SAE during this study.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|The analysis was performed on the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.|||percentage of subjects|||Number
1355580|NCT01728077|Primary|Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects withdrawn due to an AE.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)||||percentage of subjects|||Number
1355581|NCT01728077|Primary|Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period|TEAEs were defined as AEs that had onset on or after the day of first study medication dose. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)||||percentage of subjects|||Number
1355582|NCT01727895|Secondary|the Composition of Faecal Microbiota||Days 0, 6, 21|||||||
1355583|NCT01727895|Secondary|• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).||Days 0, 6, 21|||||||
1355584|NCT01727895|Secondary|• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)||Days 0, 6, 21|||||||
1355585|NCT01727895|Secondary|• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.||Days 0, 6, 21|||||||
1355586|NCT01727895|Secondary|• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA||Days 0, 6, 21|||||||
1355587|NCT01727895|Secondary|• Production of Other Cytokines (TNF-α, Interleukin (IL)-6, IL-10, IL-1β, IL-17, IL-22, Interferon (IFN)-γ) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)||days 0, 6, 21|||||||
1355588|NCT01727895|Primary|Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)|The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response|up to 21 days||||pg/ml||Inter-Quartile Range|Median
1355589|NCT01727791|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.|||participants|||Number
1355590|NCT01727791|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.|||participants|||Number
1355591|NCT01727791|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.|||participants|||Number
1355592|NCT01727791|Primary|Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)|Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||percentage of dose||Full Range|Mean
1355593|NCT01727791|Primary|Body Weight Normalized Maternal Dose (BWNMD)|Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/kg/day||Full Range|Mean
1355594|NCT01727791|Primary|Body Weight Normalized Infant Dose (BWNID)|Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/kg/day||Full Range|Mean
1355595|NCT01727791|Primary|Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)|Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||ratio||Full Range|Mean
1355596|NCT01727791|Primary|Milk to Plasma Ratio for AUCtau (MPAUCtau)|MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||ratio||Full Range|Mean
1355597|NCT01727791|Primary|Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)|Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg||Full Range|Mean
1355598|NCT01727791|Primary|Renal Clearance (CLr)|Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1355599|NCT01727791|Primary|Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)|Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
1355600|NCT01727791|Primary|Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)|Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mg||Geometric Coefficient of Variation|Geometric Mean
1355601|NCT01727791|Primary|Breast Milk Clearance (CLbm)|Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1355604|NCT01727791|Primary|Average Breast Milk Concentration During the Dosing Interval (Cav)|Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Full Range|Mean
1355605|NCT01727791|Primary|Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])|The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Standard Deviation|Mean
1355606|NCT01727791|Primary|Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])|Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Full Range|Median
1355607|NCT01727791|Primary|Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])|Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1355608|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])|AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1355609|NCT01727791|Primary|Apparent Oral Clearance (CL/F)|Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mL/minute||Geometric Coefficient of Variation|Geometric Mean
1355610|NCT01727791|Primary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1355611|NCT01727791|Primary|Average Plasma Concentration During the Dosing Interval (Cav)|Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1355612|NCT01727791|Primary|Plasma Half-Life (t1/2)|Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Standard Deviation|Mean
1355613|NCT01727791|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was the time to peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Full Range|Median
1355614|NCT01727791|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was the peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1355615|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The pharmacokinetic (PK) parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||microgram*hour/milliliter (mcg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1355625|NCT01727713|Secondary|Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).|The treatment discontinuation rate was calculated as the number of discontinued participants (ie, those withdrawn from the study without completing the Week 52 visit) divided by the number of all enrolled participants.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Percentage of discontinued participants|||Number
1355616|NCT01727726|Secondary|Sheehan Disability Scale (SDS) Individual Item Scores.|To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale (a self rated questionnaire) was used for measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains (work/school work, social life/leisure activities and family life/home responsibilities). All domains were rated on a score scale ranged from 0 (no impairment) to 10 (most severe). Score of 5 and above indicated significant functional impairment. A total score was addition of the 3 individual scores and the total score ranged from 0 (no impairment) to 30 (most severe).|Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||units on a scale||Standard Error|Least Squares Mean
1355617|NCT01727726|Secondary|Number of Participants With Adverse Events|To evaluate the safety and tolerability of brexpiprazole (flexible dose) as adjunctive therapy to ADT in the proposed subject population with MDD as AE variables.|From screening (Day -28 to Day-1) upto post treatment follow-up.|Randomized subjects in Phase B who received at least one dose of double-blind trial medication as indicated on the dosing record.|||Participants|||Count of Participants
1355618|NCT01727726|Secondary|CGI-I Response Rate|CGI-I Response rate, where response was defined as a CGI-I score of 1 or 2 (very much improved or much improved), during double-blind randomized Phase B treatment.|Phase B week 6 (14/16 weeks after randomization).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||Participants|||Count of Participants
1355619|NCT01727726|Secondary|Number of Participants With MADRS|MADRS Remission Rate, where remission was defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score, for every trial week visit during double-blind randomized Phase B treatment.|Phase B week 6 (14/16 weeks after randomization).|Number of subjects in the Safety Sample who had an end of Phase A (ie, Week 8 or 10) value and at least one post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Participants|||Count of Participants
1355620|NCT01727726|Secondary|MADRS Response at Week 6|MADRS Response Rate, where response was defined as 50% reduction in MADRS Total Score, during double-blind randomized Phase B treatment.|Phase B week 6 (14/16 weeks after randomization).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||Participants|||Count of Participants
1355621|NCT01727726|Secondary|Clinical Global Impression Score|Mean change from end of Phase A in Clinical Global Impression - Severity of Illness scale (CGI-S) score and Improvement scale (CGI-I) during double-blind randomized Phase B treatment. CGI-S score assessed how mentally ill the patient was at that time. CGI-S score is calculated from 0 to 7 (0 indicates not assessed 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and7 indicated among the most extremely ill patient). CGI-I score is compared to his/her condition at baseline, how much has the patient changed. CGI-I score is calculated from 0 to 7 (0 indicates not assessed and 7 indicates very much worse).|From randomization to Phase B week 6 (14/16 weeks after randomization).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for CGI-S score and CGI-I score in Phase B.|||Mean score||Standard Deviation|Mean
1355622|NCT01727726|Secondary|Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4.|Change from end of Phase A in MADRS Total Score. The MADRS was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression.|Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14)|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||units on a scale||Standard Error|Least Squares Mean
1355623|NCT01727726|Secondary|Sheehan Disability Scale (SDS)|To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale is a measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains ( work/social life/family life/home responsibilities). The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. Scores of 5 and above are associated with significant functional impairment. Additionally, SDS included 2 questions related to productivity losses due to the psychiatric symptoms and impairment.|Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for SDS Score in Phase B.|||units on a scale||Standard Error|Least Squares Mean
1355624|NCT01727726|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|To determine the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy by assessment of MADRS total score. The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression.|Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1355626|NCT01727713|Secondary|Percentage of Participants With Response (Response Rate).|Clinical response was defined as > 25% improvement from Baseline to endpoint in YGTSS TTS or a CGI-TS change score of 1 (very much improved) or 2 (much improved) at endpoint.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Percentage of participants with response|||Number
1355627|NCT01727713|Secondary|Mean Change From Baseline to Endpoint in Total YGTSS Score.|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) for motor and vocal tics, and an impairment ranking. The YGTSS TTS is the summation of the severity scores of motor and vocal tics (range of 0 [no impairment] to 50 [maximum impairment]). The total YGTSS score is the summation of the severity scores of motor and vocal tics and the ranking of impairment (total range of 0 [no impairment] to 100 [maximum impairment]).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1355628|NCT01727713|Secondary|Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.|The final CGI-TS score was compared to the participant’s baseline condition at the time of entry into the open-label study, rather than the CGI-TS baseline condition at the time participants enrolled into the preceding study. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1355629|NCT01727713|Secondary|Mean Clinical Global Impressions for Tourette’s Syndrome (CGI-TS) Change Score at Endpoint.|The CGI is a 7-point Likert scale used in a multitude of clinical trials as a clinical global measure to assess the severity and change in disease symptomatology (ie, tics). The CGI was included as a secondary scale to provide a more complete assessment of clinical efficacy. To assess CGI-TS severity, the rater or investigator will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” However, the evaluation of illness will be limited to manifestations of Tourette’s Disorder only. Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1355630|NCT01727713|Secondary|Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).|The YGTSS is a semi-structured clinical interview which consists of a tic inventory, with 5 separate ratings to assess the number, intensity, frequency, complexity and interference of tics, plus an overall impairment/disability score. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the secondary outcome measure in this trial. The YGTSS ranking of impairment, with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. The total severity score ranged from 0 (no impairment) to 50 (worst impairment).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1355631|NCT01727713|Primary|Change From Baseline in Pediatric Anxiety Rating Scale (PARS).|The PARS is used to rate the severity of anxiety in children and adolescents, aged 6 to 17 years. The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child’s repertoire of symptoms during the past week. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score was the sum of items 2, 3, 5, 6, and 7. The total severity score ranged from 0 (no anxiety) to 25 (worst anxiety).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355632|NCT01727713|Primary|Change From Baseline in Children’s Depression Rating Scale - Revised (CDRS-R).|The CDRS-R is a brief rating scale based on a semi-structured interview with the child and an adult informant who knows the child well. Designed for 6- to 12-year-old children, and successfully used with adolescents, it can be administered in 15 to 20 minutes. The interviewer rates 17 symptom areas (including those that serve as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for a diagnosis of depression): impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355642|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).|Three 12-lead ECGs (scheduled 5 minutes apart) were recorded. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: Tachycardia/sinus tachycardia: increase of ≥15 bpm from Baseline; increase in QTc of ≥10% from Baseline. The other abnormalities not present at Baseline and were present during the time of measurement were recorded. Percentage of participants noted with abnormal ECG findings are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline ECG result were included.|||Percentage of participants|||Number
1356064|NCT01721603|Secondary|Median Progression-free Survival|Determine the median progression-free survival of BRAFV600E melanoma brain metastasis patients treated with SRS, trametinib and dabrafenib.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
1355633|NCT01727713|Primary|Change From Baseline in Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS).|The CY-BOCS is a semi-structured interview used with children and adolescents aged 6 to 17 years to rate the severity and type of symptoms in participants with obsessive compulsive disorder. In general, the items depend on the participant's report; however, the final rating is based on the clinical judgment of the interviewer and should include additional information supplied by others. Nineteen items are rated in the CY-BOCS, but only items 1 through 10 (excluding items lb and 6b) are used to determine the total score. The total CY-BOCS score is the sum of items 1 through 10 (excluding lb and 6b), whereas the obsession and compulsion subtotals are the sums of items 1 through 5 (excluding lb) and 6 through 10 (excluding 6b), respectively. CY-BOCS total score could range from 0 to 40, and the obsession and compulsion subscale total scores could each range from 0 to 20. Higher scores indicate worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355634|NCT01727713|Primary|Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).|The SNAP-IV Rating Scale is a revision of the SNAP Questionnaire. The SNAP-IV assesses inattention and hyperactivity/impulsivity, as well as oppositional defiant disorder that are often present in children with ADD/ADHD. The SNAP-IV was administered as a semi-structured interview with the participant and caregiver. The SNAP-IV is based on a 0 to 3 rating scale: not at all = 0, just a little = 1, quite a bit = 2, and very much = 3. The ADD/ADHD subscale includes items 1 through 19 (items 1–9 measure inattention, items 11–19 measure hyperactivity/ impulsivity, and item 10 for inattention domain), items 4, 8, 11, 31, and 32 measure inattention/overactivity, and items 21, 23, 29, 34, and 35 measure aggression/defiance. Items 4, 8, 11, 21, 32, 33, 36, 37, 38, and 39 form the Conners Index. Subscale average scores on the SNAP IV were calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355635|NCT01727713|Primary|Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).|The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline/“since last visit” evaluation that focuses on suicidality since the last trial visit. The C-SSRS data at Baseline and post baseline were summarized for incidence of reporting: Suicidality, Suicidal behavior (and its 4 types), Suicidal ideation (and its 5 types). The intensity score of each item ranges from 1 (least severe) to 5 (most severe), which leads to the range of the total score from 0 to 25.|Baseline, Weeks 1, 2, 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355636|NCT01727713|Primary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.|The BARS Global Score is derived from the global clinical evaluation of akathisia on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355637|NCT01727713|Primary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score.|The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of 1 representing absence of symptoms, and a score of 5 representing a severe condition. The SAS total score (range 10 to 50) was the sum of the rating scores for 10 items from the SAS panel.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355638|NCT01727713|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.|The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest, and the investigator also made global judgments on the participant's dyskinesias (items 8 through 10). Each item was rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness/severe distress). In addition, the AIMS included 2 yes/no questions that addressed the subject’s dental status (since an edentulous state can cause lingual dyskinesias). The AIMS movement rating score (range 0 to 28) was the sum of the rating scores for facial and oral moments (ie, items 1 to 4), extremity movements (ie, items 5 and 6), and trunk movements (ie, item 7).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
1355639|NCT01727713|Primary|Mean Change From Baseline in Waist Circumference.|Waist circumference was measured at Baseline, Weeks 12, 28, 36, 44, and the Week 52/last visit in centimeters.|Baseline to Weeks 12, 28, 36, 44, and 52/last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline waist circumference measurement.|||Centimeter||Standard Deviation|Mean
1355640|NCT01727713|Primary|Mean Change From Baseline in Body Mass Index (BMI).|BMI was calculated at the Baseline visit (using the Baseline height from study 31-12-293) and at Weeks 28 and 52/ET where height measured at baseline in the current trial was used to calculate BMI.|Baseline to Weeks 28, 52 and Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline BMI measurement.|||Kg/M^2||Standard Deviation|Mean
1355641|NCT01727713|Primary|Mean Change From Baseline in Body Weight.|Criteria for identifying weight of potential clinical relevance was: ≥ 7% kilogram increase/decrease from Baseline (Final visit of Trial 31-12-293).|Baseline to Weeks 12, 28, 36, 44, 52/Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline weight measurement.|||Kilogram||Standard Deviation|Mean
1356144|NCT01721109|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis||Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1355643|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Vital Signs.|Vital sign measurements included systolic and diastolic blood pressure (BP) and heart rate, which were performed at all clinic visits. Criteria for identifying vital signs of potential clinical relevance included: Heart rate: ≥ 15 beats per minute (bpm) increase/decrease from Baseline (final visit of study 31-12-293); Systolic BP: ≥ 20 mmHg increase/decrease from Baseline; Diastolic BP: ≥ 15mmHg increase/decrease from Baseline; Orthostatic hypotension: ≥ 20 mmHg decrease in systolic BP and a ≥ 25 bpm increase in heart rate from supine to sitting/standing. Percentage of participants noted with abnormal vital sign measurements are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline vital sign result were included.|||Percentage of participants|||Number
1355644|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.|Laboratory tests including hematology, serum chemistry, and urinalysis were performed for all the participants. The central laboratory was used for all laboratory testing whenever possible. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant based on the pre-defined criteria for identifying laboratory values of potential clinical relevance. Percentage of participants noted with abnormal laboratory values are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline laboratory value were included.|||Percentage of participants|||Number
1355645|NCT01727713|Primary|Percentage of Participants With Adverse Events.|An AE is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the study drug. A treatment emergent adverse event (TEAE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to have a causal relationship with the study drug. Serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolonged hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.|Baseline, throighout the 52-week treatmetn and 30±3 days after last trial visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Percentage of participants|||Number
1355646|NCT01727700|Secondary|Treatment Discontinuation Rate|Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment.|||Percentage of participants|||Number
1355647|NCT01727700|Secondary|Response Rate|Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Percentage of Responders|||Number
1355648|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score|The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
1355649|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
1355650|NCT01727700|Secondary|Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.|To assess CGI-TS severity, the rater or physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
1355663|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1355651|NCT01727700|Primary|Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).|The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.|Baseline to Week 8|Intent-to-Treat (ITT) Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
1355652|NCT01727505|Other Pre-specified|Tidal Volume|The mean exhaled tidal volume of mechanical breaths.|24 hours||||ml/Kg||Standard Deviation|Mean
1355653|NCT01727505|Other Pre-specified|Fraction of Inspired Oxygen (FiO2)|"Calculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods.~Reported as median and inter-quartile range of all subjects."|24 hours||||fraction||Inter-Quartile Range|Median
1355654|NCT01727505|Secondary|Duration of Hypoxemia Episodes|Duration of hypoxemia episodes of arterial saturation < 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects.|24 hours||||seconds||Inter-Quartile Range|Median
1355655|NCT01727505|Secondary|Frequency of Hypoxemia Episodes|Frequency of hypoxemia episodes defined as episodes with arterial saturation < 85% for at least 20 seconds|24 hours||||hypoxemia episodes per hour||Inter-Quartile Range|Median
1355656|NCT01727505|Secondary|Frequency of Severe Hypoxemia Episodes|Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 < 75% lasting for at least 20 seconds.|24 hours||||severe hypoxemia episodes per hour||Inter-Quartile Range|Median
1355657|NCT01727505|Primary|Percentage of Time Spent With Arterial Oxygen Saturation < 75%|Percentage of time spent with arterial oxygen saturation < 75%|24 hours||||% of time||Inter-Quartile Range|Median
1355658|NCT01727414|Primary|ADHD Total Symptom Score|"Assessed via parent and teacher-completed Vanderbilt ADHD Rating Scales which were administered at the end of each the 4 weeks of the titration trial.~Range: 0-54 [sum of 18 symptom items, rated from 0 (none), 1 (occasionally), 2 (often), 3 (very often)], higher scores indicate more ADHD symptoms Note to address Review Comment: During the 4 week titration trial, the placebo condition and each of the three active dosages (low, medium, and high) were given for one week each. Because the placebo and active dosages were given in random order to preserve the triple blind, all participants did not receive the same order of dosages and it is not possible to connect the connect the dosages (placebo, low dose MPH, medium dose MPH, high dose MPH) to a specific week number (week 1, week 2, week 3, week 4) which would hold for ALL participants. That is why Timeframe was revised from week 1, week 2, week 3, week 4 to placebo, low dose, medium dose, and high dose week."|End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week||||units on a scale||Standard Deviation|Mean
1355659|NCT01727297|Secondary|Actions Taken in Response to Awareness of AF|Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized|Time from first identified episode of AF to study exit (maximum of 30 months)|"Each visit represents the number of subjects who had a 1st, 2nd, 3rd visit, etc. in which AF was identified by the physician. Subjects in the Sixth Visit with AF Detected column had 6 visits in which AF was detected by the physician, and the column reflects the actions taken at that sixth visit."|||Actions at Visits|Actions at Visits||Count of Units
1355660|NCT01727297|Secondary|Predictors of the Incidence of AF|AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.|Time from implant to date of last stored available device data (maximum of 30 months)|This analysis only included patients who received an implantable cardiac monitor, were not on antiarrhythmic medications at baseline, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 1 subject was on antiarrhythmic medication, and 2 subjects had no post-implant device data.|||Participants|||Count of Participants
1355661|NCT01727297|Primary|18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes|Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.|Implant to 18 months post device insertion|This analysis only included patients who received an implantable cardiac monitor, met all inclusion/exclusion criteria, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 7 subjects did not meet all inclusion/exclusion criteria, and 2 subjects had no post-implant device data.|||percent of participants|||Number
1355662|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1355922|NCT01724359|Secondary|Sleep Evaluation Scale|This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355664|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1355665|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1355666|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
1355667|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
1355668|NCT01727180|Primary|Visual Analog Scale (VAS)|A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable|Once at the entry of the study||||units on a scale||Standard Deviation|Mean
1355669|NCT01727167|Secondary|Compare Blood to Right Atrial Tissue Biochemical Markers of Mitochondrial Biogenesis|Biochemical markers in both right atrial tissue and blood will be measured and compared to see if the more easily obtained blood markers accurately describe changes expected in the heart.|on week|Molecular data was not collected for the single enrolled participant.||||||
1355670|NCT01727167|Primary|Biochemical Markers for Mitochondrial Biogenesis (Blood and Right Atrial Tissue)|Right atrial biochemical markers will be measured one time only, intra-operatively. Blood Biochemical markers will be measured before CO exposure and at intervals up to one week post-operatively|2 weeks|Molecular data was not collected for the single enrolled participant.||||||
1355671|NCT01727141|Secondary|Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1355672|NCT01727141|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||Number of puffs||Standard Error|Least Squares Mean
1355673|NCT01727141|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1355717|NCT01726335|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 2, 4, 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355674|NCT01727141|Secondary|Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, week 12|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1355675|NCT01727141|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1355676|NCT01727141|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1355677|NCT01727141|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1355678|NCT01727141|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 – 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1355679|NCT01727141|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1355680|NCT01727141|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1355733|NCT01726023|Secondary|Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.|Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
1355681|NCT01727141|Primary|Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.|||Liter||Standard Error|Least Squares Mean
1355682|NCT01727089|Secondary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From time of treatment initiation until conclusion of treatment, assessed every 12 weeks.||||participants|||Number
1355683|NCT01727089|Secondary|Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment|"The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be utilized for AE reporting.~Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).~Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.~Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related adverse event."|From time of treatment initiation until 30 days post treatment, assessed every 4 weeks.||||participants|||Number
1355684|NCT01727089|Primary|Progression-free Survival at 12 Weeks|Progression-free survival 12 after starting treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The duration of time from start of treatment to time of progression or death, assessed at 12 weeks||||percentage of participants||95% Confidence Interval|Number
1355685|NCT01727089|Primary|Progression-free Survival at 24 Weeks|Progression-free survival 24 after starting treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The duration of time from start of treatment to time of progression or death, assessed at 24 weeks||||percentage of participants||95% Confidence Interval|Number
1355686|NCT01727024|Secondary|Number of Participnats With Difficulties Experienced When Handling the Devices|Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.|1 week|The safety analysis set, which included participants who received at least one dose of study medication, was considered for the analysis. However, only participants who had observed values, were analyzed.|||Participants|||Number
1355687|NCT01727024|Secondary|Number of Participants With Preference for Either Device|Participants answered a single question to determine their device preference.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed.|||Participants|||Number
1355688|NCT01727024|Secondary|Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire|"Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.~The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction"|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed.|||score on a scale||Standard Deviation|Mean
1355689|NCT01727024|Secondary|Number of Participants Correctly Using the Device After One Week of Handling|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed.|||Participants|||Number
1355690|NCT01727024|Primary|Number of Participants Who Correctly Used the Device at the Start of Handling the Device|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 1|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed.|||Participants|||Number
1355691|NCT01726673|Secondary|Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)|The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.|12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)|45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.|||scores on a scale||Inter-Quartile Range|Median
1355921|NCT01724359|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355692|NCT01726673|Secondary|Median Change in WOLF Motor Function Test (WMFT)|The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.|baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)|45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.|||seconds||Inter-Quartile Range|Median
1355693|NCT01726673|Primary|Median Change in Upper Extremity Fugl Meyer Assessment Score|The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.|baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)|45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.|||scores on a scale||Inter-Quartile Range|Median
1355694|NCT01726621|Primary|User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.|Four weeks of pump wear||||units on a scale||Standard Deviation|Mean
1355695|NCT01726517|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.~Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement."|Baseline to Posttreatment Week 24||||percentage of participants|||Number
1355696|NCT01726517|Secondary|Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set|||percentage of participants|||Number
1355697|NCT01726517|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.|Baseline to Week 12|Safety Analysis Set|||participants|||Number
1355698|NCT01726517|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
1355699|NCT01726504|Secondary|Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40–60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks||||percentage of participants|||Number
1355700|NCT01726504|Secondary|The Number of Participants Using Rescue Medicine for Constipation||1-20 weeks||||participants|||Number
1355701|NCT01726504|Secondary|Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40–60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks||||number of times per week||Standard Error|Mean
1355702|NCT01726504|Secondary|Number of Participants With Adverse Events Related to Acupuncture||1-8 weeks||||participants|||Number
1355703|NCT01726504|Secondary|Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)|Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.|baseline and the end of 8th week||||score on a scale||Standard Error|Mean
1355704|NCT01726504|Secondary|Change of Average Weekly Degree of Difficulty in Defecation From Baseline|"The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.~0 = not at all~= more straining than not~= a great deal~= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline"|Baseline and weeks 1-8||||scores on a scale||Standard Error|Mean
1355769|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
1355705|NCT01726504|Secondary|Mean Scores for Stool Consistency and Straining During Weeks 1–8|average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.|Baseline and weeks 1-8||||score on a scale||Standard Error|Mean
1355706|NCT01726504|Secondary|Mean Weekly SBMs During Weeks 1-8|The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.|Baseline and weeks 1-8||||number of times||Standard Error|Mean
1355707|NCT01726504|Secondary|Changes in Mean Weekly CSBMs During Weeks 9–20|The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.|Baseline and weeks 9-20||||number of times||Standard Error|Mean
1355708|NCT01726504|Secondary|the Percentage of Participants With Three or More Weekly CSBMs|the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20|1-20 weeks||||percentage of participants|||Number
1355709|NCT01726504|Primary|the Change in Mean Weekly CSBMs During Weeks 1–8 Since Treatment|the change number in mean weekly CSBMs during weeks 1–8 since treatment compared with baseline.|Baseline and weeks 1-8||||number of times||Standard Error|Mean
1355710|NCT01726335|Secondary|Global Assessment of Functioning (GAF) Scale Score|The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355711|NCT01726335|Secondary|Personal and Social Performance (PSP) Scale Score|The PSP scale assesses the degree of a participant’s dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355712|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355713|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 38|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355714|NCT01726335|Secondary|Short Form-36 (SF-36) - Quality of Life|The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Deviation|Mean
1355715|NCT01726335|Secondary|Drug Attitude Inventory (DAI-10)|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Screening, and Week 8, 24 and 50|ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Error|Mean
1355716|NCT01726335|Secondary|Extrapyramidal Symptoms Rating Scale (ESRS) Total Score|The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).|Baseline and Week 2, 4, 8, 16, 24 and 50|Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Error|Mean
1356169|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|2 year post index procedure||||Participants|||Count of Participants
1355718|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 24|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355719|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 16|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355720|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 8|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355721|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 4|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355722|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 2|Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
1355723|NCT01726049|Other Pre-specified|Echocardiographic Parameters of Diastolic LV Dysfunction||12 weeks|||||||
1355724|NCT01726049|Secondary|Wedge Pressure Measured Invasively by Right Heart Catheterization|Difference in change of wedge pressure between baseline and 12 weeks between Sildenafil group and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in wedge pressure could be evaluated in the ITT analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group|||mmHg||95% Confidence Interval|Mean
1355725|NCT01726049|Secondary|Cardiac Output Measured Invasively by Right Heart Catheterization|difference in change of cardiac output between baseline and 12 weeks between Sildenafil and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in cardiac output could be evaluated in the ITT analyses in 20 and 22 subjects of the Sildenafil and placebo treatment group|||mililiter/min||95% Confidence Interval|Mean
1355726|NCT01726049|Secondary|VO2max|difference in change of VO2 max between baseline and 12 weeks between Sildenafil and placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in VO2max could be evaluated in the ITT analyses in 18 and 22 subjects of the Sildenafil and placebo treatment group|||ml/kg/min||95% Confidence Interval|Mean
1355727|NCT01726049|Primary|Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization|change of mean pulmonary artery pressure between baseline and 12 weeks measured by heart catheterisation|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in mean pulmonary artery pressure could be evaluated in the intention to treat (ITT) analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group|||mmHG||95% Confidence Interval|Mean
1355728|NCT01726023|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.|PK analysis set|||ng/mL||Full Range|Geometric Mean
1355729|NCT01726023|Secondary|Safety and Tolerability:ECG , QTcB and QTcF Intervals|Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.|EOT visit/any observation on treatment|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
1355730|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.|Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
1355731|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Hematology.|Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
1355732|NCT01726023|Secondary|Safety and Tolerability by Incidence: Extent of Exposure.|Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
1355734|NCT01726023|Secondary|The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|microbiological modified intent-to-treat (mMITT) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.|||Days||Full Range|Median
1355735|NCT01726023|Secondary|The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|Clinically evaluable (CE) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.|||Days||Full Range|Median
1355736|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
1355737|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
1355738|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
1355739|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Participants with favorable responses|||Number
1355740|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Participants with favorable responses|||Number
1355741|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Participants with favorable responses|||Number
1355742|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Participants with favorable responses|||Number
1355743|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Participants with favorable responses|||Number
1355744|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Participants with favorable responses|||Number
1355745|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants with favorable responses|||Number
1355746|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants with favorable responses|||Number
1355747|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants with favorable responses|||Number
1355748|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
1355770|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|3 Months Post Procedure||||percentage of subjects|||Number
1355749|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
1355750|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
1355751|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
1355752|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
1355753|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
1355754|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
1355755|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
1355756|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
1355757|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At late follow up (LFU) visits (Day 42 to 49)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Number of patients|||Number
1355758|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Number of patients|||Number
1355771|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
1355759|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
1355760|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
1355761|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
1355762|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
1355763|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
1355764|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
1355765|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
1355766|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
1355767|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
1355768|NCT01726023|Primary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure visit (Day 28 to35)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Number of patients|||Number
1355774|NCT01725984|Primary|Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.|"The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.~The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.~The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7."|Baseline to Prospective Follow Up (up to 36 months)||||Score on a scale||Standard Deviation|Mean
1355775|NCT01725984|Primary|Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit|Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
1355776|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Baseline||||percentage of subjects|||Number
1355777|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|3 months Post Procedure||||percentage of subjects|||Number
1355778|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|3 Months Post Procedure||||percentage of participants|||Number
1355779|NCT01725529|Secondary|Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level|Percentage of participants with on-treatment normalization of alanine aminotransferase level were assessed.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
1355780|NCT01725529|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual end of treatment and last HCV RNA measurement during follow-up ≥25 IU/mL.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
1355781|NCT01725529|Secondary|Percentage of Participants With Viral Breakthrough|The number of patients who experience viral breakthrough will be determined by measuring Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in plasma. Viral breakthrough was defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in subjects whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment.|Week 24 or 48 (End of Treatment)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
1355782|NCT01725529|Secondary|Percentage of Participants With On-treatment Failure|A participant with on-treatment failure refers to a participant with confirmed detectable HCV RNA at the end of treatment.|End of Treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.|||percentage of participants|||Number
1355783|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72)||Week 72|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
1355784|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24)|Participants considered to have achieved SVR24 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ;25 IU/mL) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 24 weeks after the planned end of study drug treatment.|24 weeks after the end of treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.|||percentage of participants|||Number
1355785|NCT01725529|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment.|12 weeks after the end of treatment (EOT: Week 24 or 48)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
1355786|NCT01725451|Primary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone|The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.|||nanograms per deciliter (ng/dL)||Geometric Coefficient of Variation|Geometric Mean
1355787|NCT01725451|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone|The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.|||nanograms* hours per deciliter (ng*h/dL)||Geometric Coefficient of Variation|Geometric Mean
1355788|NCT01725386|Secondary|Percentage of Participants With Adverse Events||Up to approximately 4 years|Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).|||percentage of participants|||Number
1355789|NCT01725386|Secondary|Mean Survival Time||Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||Months||95% Confidence Interval|Mean
1355790|NCT01725386|Secondary|Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
1355791|NCT01725386|Secondary|Percentage of Participants With Relevant Medical History Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
1355792|NCT01725386|Primary|Percentage of Participants Receiving Concomitant Medications During the Study|Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
1355793|NCT01725386|Primary|Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy|To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
1355794|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355795|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355796|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355811|NCT01725308|Secondary|Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe)."|Baseline and Weeks 4, 8|SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.|||units on a scale||Standard Deviation|Mean
1356173|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR|2 year post index procedure||||Participants|||Count of Participants
1355797|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355798|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355799|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355800|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors – Suicide Attempt (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355801|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).|Weeks 4, 8|SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.|||participants|||Number
1355802|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation – Suicidal Intent With a Plan (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355803|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation – Suicidal Intent Without a Plan (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1356170|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|1 year post index procedure||||Participants|||Count of Participants
1355804|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation – Suicidal Thoughts With Method (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355805|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation – Suicidal Thoughts (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||particpants|||Number
1355806|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
1355807|NCT01725308|Secondary|Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.|Weeks 4, 8|SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.|||participants|||Number
1355808|NCT01725308|Secondary|Change From Baseline in YMRS (Combined Treatment Period I and II)|"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates “Absent” or “Normal. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12."|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355809|NCT01725308|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)|"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates “Absent” or “Normal."|Baseline and Weeks 1, 2, 3, 4, 6, 8|SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.|||units on a scale||Standard Deviation|Mean
1355810|NCT01725308|Secondary|Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12."|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||umits on a scale||Standard Deviation|Mean
1355821|NCT01725308|Secondary|Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
1355812|NCT01725308|Secondary|Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12."|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355813|NCT01725308|Secondary|Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity."|Baseline and Weeks 4, 8|SAF participants with available data at each time point; LOCF was used for end of Treatment Period I.|||units on a scale||Standard Deviation|Mean
1355814|NCT01725308|Secondary|Number of Participants With Adverse Events (Combined Treatment Period I and II)|An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups.|Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E & FK949E 300 mg / FK949E groups, from week 0 to week 52)|SAF for combined Treatment Periods I and II, which included participants who were treated with FK949E at least one time.|||Participants|||Count of Participants
1355815|NCT01725308|Secondary|Number of Participants With Adverse Events (Treatment Period I)|An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.|Up to 8 weeks|Safety Analysis Set (SAF), which included participants who received at least one dose of study drug for Treatment Period I.|||participants|||Number
1355816|NCT01725308|Secondary|CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355817|NCT01725308|Secondary|CGI-BP-C: Overall Bipolar Illness (Treatment Period I)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
1355818|NCT01725308|Secondary|CGI-BP-C: Depression (Combined Treatment Period I and II)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputtion was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355819|NCT01725308|Secondary|CGI-BP-C: Depression (Treatment Period I)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
1355820|NCT01725308|Secondary|CGI-BP-C: Mania (Combined Treatment Period I and II)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355919|NCT01724528|Primary|Preservation of Renal Function|Change in serum creatinine level from baseline (Day 1) to the evaluation visit (Day 8)|8 days|ITT. Sample size calculation: no change in mean serum creatinine level from baseline to the end of treatment for febuxostat group while allopurinol has a increase of 13%; 340 patients were sufficient to achieve approximately 80% power. Imputation method: LOCF; missing baseline values were not replaced|||change %||Standard Deviation|Mean
1355822|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355823|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
1355824|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a sale||Standard Deviation|Mean
1355825|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Depression (Treatment Period I)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
1355826|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355827|NCT01725308|Secondary|Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
1355828|NCT01725308|Secondary|Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)|A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||Participants|||Count of Participants
1355829|NCT01725308|Secondary|Number of Participants With HAM-D17 Response (Treatment Period I)|A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||Participants|||Count of Participants
1355830|NCT01725308|Secondary|Change From Baseline in HAM-D17 (Combined Treatment Period I and II)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355831|NCT01725308|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
1355842|NCT01725282|Secondary|Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)|"The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened.~Improvement is defined as a score of 1 or 2."|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
1355832|NCT01725308|Secondary|Number of Participants With MADRS Remission (Combined Treatment Period I and II)|MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||Participants|||Count of Participants
1355833|NCT01725308|Secondary|Number of Participants With MADRS Remission (Treatment Period I)|MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||Participants|||Count of Participants
1355834|NCT01725308|Secondary|Number of Participants With MADRS Response (Combined Treatment Period I and II)|A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||Participants|||Count of Participants
1355835|NCT01725308|Secondary|Number of Participants With MADRS Response (Treatment Period I)|A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||Participants|||Count of Participants
1355836|NCT01725308|Secondary|Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)|The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS for combined Treatment Period I and II, which included participants who received at least one dose of FK949E and had measurements taken for at least one efficacy endpoint after the start of FK949E treatment, and with available data at each time point. LOCF imputation method was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
1355837|NCT01725308|Secondary|Change From Baseline in MADRS Total Score (Treatment Period I)|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation was used for all time points.|||units on a scale||Standard Deviation|Mean
1355838|NCT01725308|Primary|Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Week 8|FAS; Last observation carried forward (LOCF) imputation was used for end of Treatment Period I.|||units on a scale||Standard Deviation|Mean
1355839|NCT01725282|Secondary|Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests|An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|Up to 8 weeks||||participants|||Number
1355840|NCT01725282|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven “component” scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality.|Baseline and Week 6|Full analysis set with available PSQI data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1355841|NCT01725282|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)|"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are:~Limitation in physical activities because of health problems.~Limitations in usual role activities because of physical health problems.~Bodily pain.~Limitations in social activities because of physical or emotional problems.~General mental health (psychological distress and well-being).~Limitations in usual role activities because of emotional problems.~Vitality (energy and fatigue).~General health perception.~Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status."|Baseline and Week 6|Full analysis set with available SF-36 data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1356174|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR|1 year post index procedure||||Participants|||Count of Participants
1355843|NCT01725282|Secondary|Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)|The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state.|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1355844|NCT01725282|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 6|Full Analysis Set: Participants who met the following requirements: major depressive disorder confirmed at registration; at least one dose of the study drug for the treatment period was administered; and at least one efficacy variable was assessed after the start of treatment. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1355845|NCT01725217|Secondary|Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination|Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group|AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29|Analysis was done on safety dataset|||percentage of subjects|||Number
1355846|NCT01725217|Secondary|Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group|Within days 1 through 7 postvaccination|Analysis was done on safety dataset|||Percentage of Subjects|||Number
1355847|NCT01725217|Secondary|Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination|Within days 1 through 7 postvaccination|Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data|||Percentage of subjects|||Number
1355848|NCT01725217|Secondary|Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset|||Percentage of Subjects||95% Confidence Interval|Number
1355849|NCT01725217|Secondary|Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset|||human serum bactericidal assay titer||95% Confidence Interval|Geometric Mean
1355850|NCT01725217|Secondary|Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group|Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM|Day 29|Analysis was done on FAS dataset|||Percentage of subjects||95% Confidence Interval|Number
1355851|NCT01725217|Primary|Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).~The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA <1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4"|Day 29|Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29|||Percentage of subjects||95% Confidence Interval|Number
1355852|NCT01725126|Secondary|Tmax of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was planned to be determined directly from the raw concentration-time data. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.||||||
1355853|NCT01725126|Secondary|Cmax of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was planned to be determined directly from the raw concentration-time data. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.||||||
1355886|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
1355854|NCT01725126|Secondary|AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The AUC 0-t was planned to be determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C comprised of all participants in the All Subjects Population for whom a PK sample was obtained and analyzed for metformin. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.||||||
1355855|NCT01725126|Secondary|Tmax of Metformin During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at the specified time points were analyzed.|||Hours||Full Range|Median
1355856|NCT01725126|Secondary|Cmax of Metformin During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at specified time points were analyzed. The results from the descriptive summary used the PK Population. However, the results of the statistical analysis compared Day 42 to Day 1 PK only in the GSK2890457 group who were in the PK Population.|||Nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
1355857|NCT01725126|Secondary|AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The AUC (0-10 hour) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Metformin PK Population in Part A comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for metformin.|Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at specified time points were analyzed. The results from the descriptive summary used the PK Population. However, the results of the statistical analysis compared Day 42 to Day 1 PK only in the GSK2890457 group who were in the PK Population.|||Hour*nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
1355858|NCT01725126|Secondary|Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide PK Population in Part B. Only those participants available at the specified time points were analyzed.|||Hours||Full Range|Median
1355859|NCT01725126|Secondary|Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide PK Population in Part B. Only those participants available at the specified time points were analyzed. Results from descriptive summary used Liraglutide PK Population. However, results of statistical analysis compared Day 42 to Day -1 PK in GSK2890457+Liraglutide group who were in the Liraglutide PK Population.|||Nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
1355860|NCT01725126|Secondary|Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post dose. The AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Liraglutide Pharmacokinetic (PK) Population in Part B comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for Liraglutide.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide Pharmacokinetic (PK) Population in Part B. Only those participants available at specified time points were analyzed. Results from descriptive summary used Liraglutide PK Population. However, results of statistical analysis compared Day 42 to Day -1 PK in GSK2890457+Liraglutide group who were in the Liraglutide PK Population.|||Hour*nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
1355861|NCT01725126|Primary|Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C|The assessments were done at Day -1, Day 7, Day 14, Day 28, Day 42 and Follow-up Visit. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline (Day 7, 14, 28, 42 and Follow-up visit) values.|Baseline (Day -1) up to Follow-up (Day 56)|PD Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
1355920|NCT01724528|Primary|Serum Uric Acid (sUA) Level Control|Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)|8 days|Intention to treat (ITT), defined as all randomized patients. Sample size calculation: at least an absolute reduction of 100 mg x h/dL for the AUCsUA1-8 in favour of febuxostat; 340 patients were sufficient to achieve approximately 80% power. Imputation method: last observation carried forward (LOCF); missing baseline values were not replaced.|||mg x hour/dL||Standard Deviation|Mean
1355862|NCT01725126|Primary|Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C|The matsuda index was calculated from the Day -1 and Day 42 glucose and insulin results as 10,000 divided by (fasting plasma glucose x fasting plasma insulin x mean glucose at 0-2 hour post-dose x mean insulin at 0-2 hour post dose)^1/2, where glucose was measured in mmol/L and insulin in pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed. Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|||Deciliter*mL/mg*mU||Standard Deviation|Mean
1355863|NCT01725126|Primary|Change From Baseline in Homeostasis Model of Assessment–Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C|HOMA-IR was calculated from the Day -1 and Day 42 fasting glucose and insulin values using dataset generated from the HOMA-2 model. It contained the estimates for HOMA-% insulin sensitivity (S) for pairs of fasting glucose and fasting insulin values. Study data was merged with the HOMA dataset by glucose and insulin. HOMA-IR was calculated as 100/HOMA-%S. HOMA-IR was not determined for any values outside the ranges of plasma glucose 3.5 to 25.0 mmol/L (63 – 450 mg/dL) and plasma insulin 20 to 400 pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed. Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|||mU*mmol/L^2||Standard Deviation|Mean
1355864|NCT01725126|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C|Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||Percent of TL hemoglobin||Standard Error|Least Squares Mean
1355865|NCT01725126|Primary|Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C|Two fasting samples 5 minutes apart were taken for insulin. Baseline insulin level was the average of the 2 fasting samples. For insulin weighted mean AUC (0-4 hour) and weighted mean AUC (0-24 hour) was calculated for Baseline (Day -1) and end of treatment (Day 42). AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean insulin AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
1355866|NCT01725126|Primary|Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C|Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean.|Baseline (Day -1) and Day 42 of Part B and C|PD Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
1355867|NCT01725126|Primary|Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C|AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean glucose AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast. Adjusted mean is reported as least square (LS) mean.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
1355868|NCT01725126|Primary|Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C|During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. Percent change was calculated by multiplying the change from Baseline value with 100. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values.|Baseline (Day -1 and Day 1) up to Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1355869|NCT01725126|Primary|Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C|During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values.|Baseline (Day -1 and Day 1) up to Day 42|Pharmacodynamic (PD) Population comprised of all participants in the All Subjects Population who had Baseline and at least one post-Baseline assessment of the endpoint. Only those participants available at the specified time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
1355870|NCT01725126|Primary|Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C|The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day -2. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14, 28 and 41) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -2) up to Day 41|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1355871|NCT01725126|Primary|Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A|The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14 and 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1355872|NCT01725126|Primary|Change From Baseline in ECG Intervals During Part B and C|Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QTcB, QTcF and RR intervals. The assessments were done at Day -1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Follow-up (Day 56)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
1355873|NCT01725126|Primary|Change From Baseline in Electrocardiogram (ECG) Intervals During Part A|Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QT duration corrected for HR by Fridericia’s formula (QTcF) and QT duration corrected for HR by Bazett’s formula (QTcB intervals. The assessments were done at Day 1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Follow-up (Day 56)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
1355874|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1355875|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1355876|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1355887|NCT01725126|Primary|Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
1355877|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1355878|NCT01725126|Primary|Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day -1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||pH||Standard Deviation|Mean
1355879|NCT01725126|Primary|Mean pH Values of Urine During the Double-blind Treatment Period of Part A|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day 1, Day 7, Day 14, Day 28 and Day 42.|up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||pH||Standard Deviation|Mean
1355880|NCT01725126|Primary|Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1355881|NCT01725126|Primary|Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Da y 1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1355882|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. The participants were categorized as few, many, moderate, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, 20-40, 40-60. Protein and ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Bacteria and uric acid crystals ranged from few to moderate, few indicated lowest and moderate indicated highest concentration. Trace was the highest concentration of occult blood. Epithelial cells ranged from 0-5 to >10, 0-5 indicated lowest and >10 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-1 was highest concentration for hyaline casts. RBC and WBC ranged from 0-3 to 40-60, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.|||Participants|||Count of Participants
1355883|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as few, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, and 20-40. Few was the highest concentration of bacteria. Occult blood ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Epithelial cell ranged from 0-5 to 10-20, 0-5 indicated lowest and 10-20 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-5 was highest concentration for hyaline casts. Ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. RBC and WBC ranged from 0-3 to 20-40, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.|||Participants|||Count of Participants
1355884|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as rare, trace, +1, 2+, RBC’s and WBC’s as <1, 1, 2, 3 and 4. Protein concentration ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. Trace was the highest concentration for occult blood. Bacteria concentration ranged from rare to moderate, where rare indicated lowest concentration and moderate indicated highest concentration. Ketones ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. RBC and WBC ranged from <1 to 4, where <1 indicated lowest concentration and 4 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.|||Participants|||Count of Participants
1355885|NCT01725126|Primary|Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
1355918|NCT01724528|Secondary|Treatment Responder Rate|Assessment of treatment responder rate, where treatment response is defined as the maintenance of sUA ≤ 7.5 mg/dL from Day 3 to Day 8|6 days|Intention to Treat (ITT; no imputation applied|||% of patients who fail to respond|||Number
1355888|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
1355889|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1355890|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1355891|NCT01725126|Primary|Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||TI/L||Standard Deviation|Mean
1355892|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Trillion cells (TI)/L||Standard Deviation|Mean
1355893|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
1355894|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
1355895|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||GI/L||Standard Deviation|Mean
1355896|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Giga cells (GI)/L||Standard Deviation|Mean
1355897|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milliunits (mu/L)||Standard Deviation|Mean
1355898|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Nanomoles (nmol)/L||Standard Deviation|Mean
1355899|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1355900|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Units (U)/L||Standard Deviation|Mean
1355901|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
1355902|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picomoles (pmol)/L||Standard Deviation|Mean
1355903|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
1355904|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
1355905|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||umol/L||Standard Deviation|Mean
1355906|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Micromoles (umol)/L||Standard Deviation|Mean
1355907|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C|The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
1356175|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|8 months post index procedure||||Participants|||Count of Participants
1355908|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A|The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at on Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Millimoles (mmol)/L||Standard Deviation|Mean
1355909|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||IU/L||Standard Deviation|Mean
1355910|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||International unit per liter (IU/L)||Standard Deviation|Mean
1355911|NCT01725126|Primary|Number of Participants With Any Hypoglycemic Events During Part B and Part C|Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of CBG or plasma glucose value of <50 mg/dL for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as ‘hypoglycemia’ based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting).|Up to Follow-up (8 weeks)|All Subjects Population.|||Participants|||Count of Participants
1355912|NCT01725126|Primary|Number of Participants With Any Hypoglycemic Events During Part A|Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of complete blood count (CBG) or plasma glucose value of <50 milligram per deciliter (mg/dL) for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as ‘hypoglycemia’ based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting).|Up to Follow-up (8 weeks)|All Subjects Population.|||Participants|||Count of Participants
1355913|NCT01725126|Primary|Number of Participants With Any AE, SAE or Death During Part B and Part C|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as ALT >=3 x ULN, and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (8 weeks)|All Subjects Population.|||Participants|||Count of Participants
1355914|NCT01725126|Primary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (8 weeks)|All Subjects Population comprised of all randomized participants who received at least one dose of study medication (placebo or GSK2890457).|||Participants|||Count of Participants
1355915|NCT01724528|Other Pre-specified|Treatment Emergent Signs or Symptoms (TESS)|Incidence, severity, seriousness and treatment-causality of TESS|14 ± 2 days|||||||
1355916|NCT01724528|Secondary|Assessment of Clinical Tumor Lysis Syndrome (CTLS)|Assessment of CTLS, from Day 3 to Day 8. According to Cairo-Bishop definition, CTLS is defined by the presence of LTLS in addition to 1 or more of the following significant clinical complications: renal insufficiency, cardiac arrhythmias, sudden death and seizures. The grade of CTLS is defined by the maximal grade of the clinical manifestation|6 days|ITT; no imputation applied|||% of patients with CTLS occurrence|||Number
1355917|NCT01724528|Secondary|Assessment of Laboratory Tumor Lysis Syndrome (LTLS)|Assessment of LTLS, from Day 3 to Day 8. According to Cairo-Bishop definition LTLS is defined by the presence of 2 or more laboratory abnormalities including: a 25% increase or levels above normal for serum uric acid, potassium, and phosphate or a 25% decrease or levels below normal for calcium.|6 days|ITT; no imputation applied|||% of patients with LTLS occurrence|||Number
1355923|NCT01724359|Secondary|Health Status as Measured by Self-rated Health Status Survey SF-36|The SF-36 is designed to examine a person’s perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 – 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355924|NCT01724359|Secondary|Personal and Social Performance (PSP) Scale|This PSP assesses the degree of a patient’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355925|NCT01724359|Secondary|Clinical Global Impression-Severity (CGIS)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients. Higher scores indicate worsening."|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||participants|||Number
1355926|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355927|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355928|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355929|NCT01724359|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1355930|NCT01724216|Primary|Number of Head Images Successfully Collected|Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.|6-months||||Images|Participants||Number
1355931|NCT01724177|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.|From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.|||weeks||95% Confidence Interval|Median
1355932|NCT01724177|Secondary|Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC|The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.|From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks|The EE population with a response (CR, CRu, PR or SD) and consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||percentage of participants||95% Confidence Interval|Number
1355933|NCT01724177|Other Pre-specified|Time to Response|Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)|From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks|Participants with a response of PR or better.|||weeks||Full Range|Median
1355934|NCT01724177|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC|The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.|From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks|The EE population who had a documented response and consisted of participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||weeks||95% Confidence Interval|Number
1355935|NCT01724177|Secondary|Number of Participants With Treatment Emergent Adverse Events|Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks|Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.|||participants|||Number
1355936|NCT01724177|Secondary|Kaplan-Meier Estimate of Time to Progression (TTP)|Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC|From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||weeks||95% Confidence Interval|Median
1355937|NCT01724177|Secondary|Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC|PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.|From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||weeks||95% Confidence Interval|Median
1355938|NCT01724177|Primary|Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)|ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is “negative” and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared|From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks|The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||percentage of participants||95% Confidence Interval|Number
1355939|NCT01724021|Secondary|Summary of Observed Serum Rituximab Concentration||Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)|"The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||microgram per milliter||Standard Deviation|Mean
1355940|NCT01724021|Secondary|Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time||Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)|"The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||percentage of participants|||Number
1355941|NCT01724021|Secondary|Percentage of Participants With Anti-Rituximab Antibodies Over Time||Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)|"The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||percentage of participants|||Number
1355942|NCT01724021|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
1355943|NCT01724021|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
1355944|NCT01724021|Secondary|Disease-free Survival (DFS)|DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
1355945|NCT01724021|Secondary|Event-free Survival (EFS)|EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
1355946|NCT01724021|Secondary|Complete Response (CR) Rate|CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.|28 days (± 3 days) after Day 1 of the last dose of induction treatment|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
1355947|NCT01724021|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Score|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During Cycle 4, 8 of treatment (Up to 32 weeks)|"ITT population included all participants who were randomized in the study. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||units on a scale||Standard Deviation|Mean
1355948|NCT01724021|Secondary|Cancer Therapy Satisfaction Questionnaire (CTSQ) Score|CTSQ is a validated 16-item questionnaire that measures three domains related to participants’ satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During Cycle 4, 8 of treatment (Up to 32 weeks)|"ITT population included all participants who were randomized in the study. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||units on a scale||Standard Deviation|Mean
1355949|NCT01724021|Secondary|Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])|Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion|Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)|ITT population included all participants who were randomized in the study.|||minutes||Full Range|Median
1355950|NCT01724021|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization of first participant to clinical cutoff date (Up to 4 years)|The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||participants|||Number
1355951|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.|Cycle 8 (Up to 32 weeks)|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
1355952|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.|Cycle 6 (Up to 24 weeks)|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
1355953|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score|"The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.~A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
1355954|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in Parkinson’s Disease Sleep Scale 2 (PDSS-2) Total Score|"The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.~A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
1355955|NCT01723904|Secondary|Change From Baseline to the End of the Treatment Period in Time Spent “on” Without Troublesome Dyskinesia|"Absolute time spent on without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent on without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||hours/day||Standard Deviation|Mean
1355956|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in Absolute Time Spent “Off”|"Absolute time spent off is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent off decreased from Baseline and therefore indicates an improvement from Baseline.~Only subjects with time spent off at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|"Subjects with time spent off at Baseline in the FAS with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64."|||hours/day||Standard Deviation|Mean
1355957|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Average of “on” and “Off” State) Total Score|"UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).~UPDRS Part II total score (average of on and off state) is the average of UPDRS Part II total score (“on” state) and Part II total score (“off” state).~A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
1355958|NCT01723904|Primary|Change From Baseline to the End of the Treatment Period in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (“on” State) Total Score|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.~A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
1355959|NCT01723904|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable~= No side effects~= Side effects do not significantly interfere with subject's functioning~= Side effects significantly interfere with the subject's functioning~= Side effects outweigh therapeutic efficacy."|Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|From the 90 subjects in the Safatey Set, 89 are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.|||participants|||Number
1355960|NCT01723722|Primary|Length of Treatment With Opioid Medication|Up to 12 months|Up to 12 months|Completion of treatment|||days||Standard Deviation|Mean
1355961|NCT01723397|Primary|Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent|Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.|Day 2 after one week pretreatment with Nasaleze or placebo.|The analysis population includes the 12 participants who completed the study.|||units on a scale||Full Range|Median
1355969|NCT01723228|Secondary|Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24|The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'|Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline ADCS MCI-CGIC assessment. n=number of participants with the given assessment.|||participants|||Number
1355962|NCT01723254|Secondary|Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336|Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.|Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)|All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.|||units/milliliter (u/mL)||80% Confidence Interval|Number
1355963|NCT01723254|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.|Baseline up to 336 days post last study drug administration or Early Termination|All randomized participants who received at least one dose of study treatment.|||participants|||Number
1355964|NCT01723254|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.|Baseline up to 336 days post study administration or at Early Termination|All randomized participants who received at least one dose of study treatment.|||participants|||Number
1355965|NCT01723254|Primary|Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination|Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: >2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [>=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).|Within 14 days|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||80% Confidence Interval|Number
1355966|NCT01723254|Primary|Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination|Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [>] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: >10 cm or 21 caliper units and above).|Within 14 days|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||80% Confidence Interval|Number
1355967|NCT01723228|Secondary|Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score|UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS ADL Subscale (Part 2) assessment.|||units on a scale||Standard Error|Least Squares Mean
1355968|NCT01723228|Secondary|Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score|UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS Motor Subscale (Part 3) assessment.|||units on a scale||Standard Error|Least Squares Mean
1355970|NCT01723228|Secondary|Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score|The PDAQ is a 15-item questionnaire that assesses the patient’s difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline PDAQ assessment.|||units on a scale||Standard Error|Least Squares Mean
1355971|NCT01723228|Secondary|Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score|The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline MoCA assessment.|||units on a scale||Standard Error|Least Squares Mean
1355972|NCT01723228|Primary|Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score|The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline SCOPA-COG assessment.|||units on a scale||Standard Error|Least Squares Mean
1355973|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
1355974|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
1355975|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
1355976|NCT01722994|Secondary|Length of Time Till Absorbable Suture Fall Out|The time post placement when the suture fell out.|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||Days||Standard Deviation|Mean
1355977|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
1355978|NCT01722929|Primary|Measure Temperature at 3 Time Points||Baseline, 48 hours from baseline, and 2 weeks from baseline||||Degrees Celsius||Standard Deviation|Mean
1355979|NCT01722877|Other Pre-specified|Acute Device Success|Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.|intraprocedural||||limbs|limbs||Count of Units
1355980|NCT01722877|Secondary|Target Lesion Revascularization|Reintervention on the same index lesion at 6 months|6 months||||lesions|lesions||Count of Units
1355981|NCT01722877|Secondary|Patency|Patency is defined as Peak Systolic Velocity Ratio (PSVR) of < 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.|6 months||||limbs|limbs||Count of Units
1355982|NCT01722877|Primary|Acute Procedural Success|Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.|intraprocedural||||limbs|limbs||Count of Units
1355983|NCT01722734|Primary|Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment|Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.|70 hours|The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.|||percentage of participants||95% Confidence Interval|Number
1355984|NCT01722643|Secondary|Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment|Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.|12 months following enrollment|1 participant in the MaxIM arm and 1 participant in the Usual Care arm did not provide meter data at 12 months so do not have data for this outcome.|||readings per day||Standard Error|Least Squares Mean
1355985|NCT01722643|Primary|HbA1c at 12 Months|Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c|12 months following enrollment||||percentage glycated hemoglobin||Standard Error|Least Squares Mean
1355986|NCT01722552|Secondary|Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period|Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.|6 months||||Participants|||Count of Participants
1356016|NCT01722266|Secondary|Reduction in the Area Under Curve(AUC) of Glucose Following the Meal||12 weeks|||||||
1355987|NCT01722552|Primary|Difference in Proportion of Subjects Who Achieve >/= 95% Adherence|Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.|Measured at 6 months after start of intervention||||Participants|||Count of Participants
1355988|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia|In randomized subjects with baseline platelet ≤ 100 x 10^9/L, the proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects With Baseline Thrombocytopenia|||Percentage of Participants|||Number
1355989|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement|The proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Percentage of Participants|||Number
1355990|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia|In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects with Baseline Anemia|||Percentage of Participants|||Number
1355991|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement|The proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Percentage of Participants|||Number
1355992|NCT01722487|Secondary|ORR (Overall Response Rate)|ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||percentage of participants|||Number
1355993|NCT01722487|Secondary|Overall Survival (OS)|OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Months||95% Confidence Interval|Median
1355994|NCT01722487|Primary|PFS (Progression Free Survival)|"The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS~Progressive disease according to 2008 IWCLL guidelines was defined as:~Group A~Lymphadenopathy, increase ≥50%~Hepatomegaly, increase ≥50%~Splenomegaly, increase ≥50%~Blood lymphocytes, increase ≥ 50% over baseline~Group B~Platelets counts, decrease of ≥ 50% from baseline secondary to CLL~Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL"|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Months||95% Confidence Interval|Median
1355995|NCT01722435|Secondary|Mean Time Staying in OST|Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).|18 months||||days||Standard Deviation|Mean
1355996|NCT01722435|Secondary|Mean Time to Drop-out of OST|Mean time of study participation (M, SD) until drop-out of treatment.|18 months||||days||Standard Deviation|Mean
1355997|NCT01722435|Secondary|Mean Time to Complete OST|Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).|18 months||||days||Standard Deviation|Mean
1355998|NCT01722435|Primary|OST Drop-outs|Participants dropped out of OST Treatment during the study period.|18 months||||participants|||Number
1355999|NCT01722435|Primary|Completion of OST|Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.|18 months||||participants|||Number
1356000|NCT01722331|Secondary|Percentage of Participants With DLQI Score of 0 or 1 at Week 12|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have a DLQI measurement at Week 12 (or end of trial if prior to Week 12).|||Percentage of participants|||Number
1356001|NCT01722331|Secondary|Change From Baseline in the Participant DLQI Score at Week 12|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.|Baseline and Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have at least one DLQI measurement (post-baseline or baseline).|||Score on a scale||95% Confidence Interval|Least Squares Mean
1356017|NCT01722266|Secondary|Percent Time Spent in Hyperglycemia and Hypoglycemia||12 weeks|||||||
1356018|NCT01722266|Secondary|Change in Total Insulin Dose From Baseline at 12 Weeks|Total insulin dose = Basal insulin dose plus bolus insulin dose.|Baseline and 12 weeks||||Units||Standard Error|Mean
1356002|NCT01722331|Secondary|Baseline Dermatology Life Quality Index (DLQI) Score|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have baseline DLQI measurement|||Score on a scale||Standard Deviation|Mean
1356003|NCT01722331|Secondary|Percentage of Participants With PASI-100 Response at Week 12|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of participants|||Number
1356004|NCT01722331|Secondary|Percentage of Participants With PASI-90 Response At Week 12|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of participants|||Number
1356005|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to an Adverse Event (Extension Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 192 weeks||2020-05-31|05/2020||||
1356006|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to a Drug-Related AE (Extension Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 192 weeks||2020-05-31|05/2020||||
1356007|NCT01722331|Primary|Number of Participants Experiencing an Adverse Event (Extension Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 212 weeks (including 20-week follow-up)||2020-10-31|10/2020||||
1356008|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)|A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.|Up to 12 weeks|Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.|||Participants|||Count of Participants
1356009|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.|||Participants|||Count of Participants
1356010|NCT01722331|Primary|Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.|||Participants|||Count of Participants
1356011|NCT01722331|Primary|Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study)|The PGA is used to determine the overall severity of a participant’s psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Baseline and Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of Participants|||Number
1356012|NCT01722331|Primary|Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0–4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of Participants|||Number
1356013|NCT01722266|Secondary|Insulin, C-peptide, Glucagon, GLP-1(Glucagon Like Peptide-1) and GIP(Gastric Inhibitory Polypeptide) Concentrations Following Meal Challenge.||12 weeks|||||||
1356014|NCT01722266|Secondary|Carbohydrate Intake||12 weeks||||grams||Standard Error|Mean
1356015|NCT01722266|Secondary|Serum Acetaminophen Concentrations Following Meal Challenge||12 weeks|||||||
1356022|NCT01722162|Primary|Progression Free Survival (Arm B)|"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Until progressive disease (PD) (up to 60 days)||||proportion of patients with PFS||95% Confidence Interval|Number
1356023|NCT01722162|Secondary|Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events|NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 6 months|Arm A: 4 patients not evaluable for outcome measure (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, & 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable because of noncompliance after enrollment but before treatment|||participants|||Number
1356024|NCT01722162|Primary|Progression Free Survival (Arm A)|"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Until progressive disease (PD) (estimated to be 92 days)||||proportion of patients with PFS||95% Confidence Interval|Number
1356025|NCT01722097|Other Pre-specified|Patient-movements|Number of unintended and unwanted patient-movements registered by the surgeon|During surgery|||||||
1356026|NCT01722097|Secondary|Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)|"Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.~Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.~Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery."|within 14 days||||units on a scale*days||Inter-Quartile Range|Median
1356027|NCT01722097|Primary|Shoulder Pain|"Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation.~VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100)."|within 14 days||||participants|||Number
1356028|NCT01722071|Primary|Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.|"Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.~Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.~Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates)."|Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).|Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.|||BOLD signal change (beta values)||Standard Error|Mean
1356029|NCT01722045|Other Pre-specified|Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES)|EES included all eligible patients who were treated in the study eye, untreated in the fellow eye, had baseline specular microscopy image in both eyes, and completed week 52 evaluation in both eyes and treatment with systemic anti-VEGF therapeutics|At week 24 and At week 52|EES|||percent change from baseline||Standard Deviation|Mean
1356030|NCT01722045|Secondary|Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline to Week 100|FAS|||percentage of participants|||Number
1356031|NCT01722045|Secondary|Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline to Week 100|FAS|||percentage of participants|||Number
1356032|NCT01722045|Secondary|Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.|Baseline to Week 52|FAS|||Letters correctly read||Standard Deviation|Mean
1356033|NCT01722045|Secondary|Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.|At week 52 and At week 100|FAS|||percentage of participants|||Number
1356034|NCT01722045|Secondary|Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was “Dry” at Week 52 and at Week 100 (LOCF)|Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to Week 100|Full analysis set (FAS)|||percentage of participants|||Number
1356035|NCT01722045|Primary|Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.|Baseline to Week 100|Results are presented for the full analysis set (FAS). FAS included all patients who received at least one dose of study drug in the study eye, had baseline Best Corrected Visual Acuity (BCVA) assessment on the study eye, and had at least one post-baseline BCVA assessment on the study eye.|||letters correctly read||Standard Deviation|Mean
1356036|NCT01721967|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established|60 days post treatement||||units on a scale||Standard Deviation|Mean
1356037|NCT01721967|Secondary|Seattle Angina Questionnaire (SAQ)|The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.|60 Days post treatment||||units on a scale||Standard Deviation|Mean
1356038|NCT01721967|Secondary|Improvement in Number of Episodes of Angina Per Week|Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).|Baseline and 60 Days post treatment|episodes of angina per week was not collected||||||
1356039|NCT01721967|Primary|Drug Tolerability|Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose|60 days||||participants|||Number
1356040|NCT01721967|Primary|Number of Adverse Events Considered Probably or Possibly Related to Study Drug|Number of events that are considered probably or possibly related to study drug.|60 Days||||adverse event|||Number
1356041|NCT01721967|Primary|QT Interval||60 Days||||msec||Standard Deviation|Mean
1356042|NCT01721837|Primary|Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)|The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.|One single observation time point: at the time of prescription before the first intake of dabigatran etexilate|All patients with documented mild or moderate renal impairment and non-valvular atrial fibrillation (PPS) having evaluable data for age, gender, body weight, and serum creatinine. In 145 patients age, gender, serum creatinine or weight was missing so that Creatinine Clearance according to the Cockcroft Gault formula could not be recalculated.|||ml/min||Inter-Quartile Range|Median
1356043|NCT01721772|Secondary|Change From Baseline in Health-related Quality of Life (HRQoL) Scores|HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.|At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 17 months|All participants randomized to receive treatment; n=number of participants evaluable|||Units on a scale||Standard Deviation|Mean
1356044|NCT01721772|Primary|Overall Survival (OS) Rate|OS rate is calculated as the percentage of participants who have not died divided by the total number of participants in the arm, based on Kaplan-Meier estimates|Randomization to 6 months and 12 months|All participants randomized to receive treatment|||Percentage of participants||95% Confidence Interval|Number
1356045|NCT01721772|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, and Drug-related AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|Day of first dose to day of final dose + 30 days, assessed up go 17 months|All participants who received at least 1 dose of study drug|||Participants|||Number
1356046|NCT01721772|Secondary|Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level|Overall Survival by PD-L1 expression level, which was defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% versus patients with tumor PD-L1 expression <5%. Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.|From date of randomization to date of disease progression or death, as assessed to 17 months|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
1356065|NCT01721603|Secondary|Systemic Overall Response Rate|"Determine the systemic best overall response rate of BRAFV600E melanoma brain metastasis patients treated with SRS, trametinib and dabrafenib.~The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).~The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented."|From surgery up to 12 months||||Participants|||Count of Participants
1356171|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|8 months post index procedure||||Participants|||Count of Participants
1356047|NCT01721772|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with a best overall response of RECIST-defined complete response (CR) or partial response (PR) divided by the number of randomized participants in each treatment arm. RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment|||Percentage of participants||95% Confidence Interval|Number
1356048|NCT01721772|Secondary|Progression-free Survival (PFS) Rate|The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment|||Percentage of participants||95% Confidence Interval|Number
1356049|NCT01721772|Secondary|Progression-free Survival (PFS)|Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were censored on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.|From date of randomization to date of disease progression or death, assessed to 17 months|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
1356050|NCT01721772|Primary|Overall Survival (OS)|OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.|From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed to 17 months.|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
1356051|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.~Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1356052|NCT01721759|Secondary|Objective Response Rate (ORR) as Assessed by Investigator|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment.~Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using RECIST v1.1, to confirm response."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1356053|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.~Participants were evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 19 months|Participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1356054|NCT01721746|Secondary|Mean Change From Baseline in Health-related Quality of Life (HRQoL) Global Health Status Scores|Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument’s 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL; an increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL; a decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.|From Baseline (Day1) to second Follow-Up; up to 37 months|All randomized participants with a baseline measurement and at least one on-study assessment; n=number of participants evaluable|||units on a scale||Standard Deviation|Mean
1356055|NCT01721746|Secondary|Median Overall Survival (OS) Time in Months by Baseline PD-L1 Expression|"PD-L1 expression evaluated as a predictive biomarker for OS by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as Subjects without Tumor Tissue Samples. Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. The interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going."|From the date of randomization to the date of death; up to 37 months|All PD-L1 Evaluable Participants; Randomized participants among the OS population who had a tumor biopsy specimen assessed for PD-L1 expression with the validated assay and for which quantifiable tumor PD-L1 levels were discernible.|||months||95% Confidence Interval|Median
1356056|NCT01721746|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression|PD-L1 expression evaluated as a predictive biomarker for ORR by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as “Subjects without Tumor Tissue Samples”. ORR=number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants and reported as a percentage. Analysis made at Primary Endpoint; Study On-going.|From date of randomization to the date of objectively documented progression or the date of subsequent therapy; approx. 16 months|All PD-L1 Evaluable Participants; Randomized participants among the ORR population who had a tumor biopsy specimen assessed for PD-L1 expression with the validated assay and for which quantifiable tumor PD-L1 levels were discernible.|||percentage of participants||95% Confidence Interval|Number
1356057|NCT01721746|Secondary|Median Months of Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRC/IRRC)|PFS=time from randomization to the date of the first documented progression or death due to any cause, whichever first. Participants who (1) died without a reported progression were considered to have progressed on the date of their death, (2) did not progress or die were censored on the date of their last evaluable tumor assessment, (3) did not have any on study tumor assessments and did not die were censored on the date they were randomized, and (4) started any subsequent anti-cancer therapy (including tumor-directed radiotherapy or surgery) without a prior reported progression were censored at the last evaluable tumor assessment prior to or upon initiation of the subsequent anti-cancer therapy. Per RECIST 1.1, progression is >= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes baseline sum if smallest on study). The sum must demonstrate an absolute increase of >= 5 mm. Analysis made at Primary Endpoint; Study On-going|From the date of randomization to the date of the first documented progression or death; up to 37 months|All Randomized Participants: All participants randomized to any treatment group|||months||95% Confidence Interval|Number
1356058|NCT01721746|Primary|Median Overall Survival (OS) at Primary Endpoint|Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. This interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going.|From the date of randomization to the date of death; up to 37 months|All Randomized Participants: All participants randomized to any treatment group|||months||95% Confidence Interval|Number
1356059|NCT01721746|Primary|Objective Response Rate (ORR)|ORR=number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants and reported as a percentage. BOR was defined as the best response designation, as determined by the independent review committee (IRC), recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Analysis made at Primary Endpoint; Study On-going|From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy; approx. 16 months|All Randomized Participants: All participants randomized to any treatment group|||percentage of participants||95% Confidence Interval|Number
1356060|NCT01721681|Secondary|Pharmacokinetics: FX:C Incremental Recovery|One of the secondary objectives was to assess the pharmacokinetics (FX:C incremental recovery 30 minute post-dose at the Visit 1 (Baseline) and the End of Study Visit after a single dose of 50 IU/kg). The overall mean IR calculated for both visits is presented in the outcome measure table.|Baseline Visit and End of Study Visit, 30 minutes post-dose|Plasma concentrations were obtained for FX:C for all 9 subjects at 30 minutes post dose at Visit 1 and Visit 5.|||IU/dL||95% Confidence Interval|Mean
1356061|NCT01721681|Secondary|Safety of FACTOR X: Number of Participants Experiencing Adverse Events|One of the secondary objectives was to assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks). The general strategy of the safety evaluation was to examine the summaries for any trends. No formal hypothesis was carried out. The number of participants who experienced Adverse Events is provided.|6 months|The safety evaluation examined the summaries for any trends. No formal hypothesis was carried out.|||Participants|||Count of Participants
1356062|NCT01721681|Primary|The Number of Participants With Excellent Reduction in Bleeding When Given FACTOR X as Routine Prophylaxis Over 6 Months|"The Investigator's assessment of the efficacy of FACTOR X in reduction/prevention of bleeding when given as routine prophylaxis over 6 months.~The efficacy was assessed according to tabulated criteria; Excellent, good, poor, unassessable."|6 months||||Participants|||Count of Participants
1356063|NCT01721603|Secondary|Median Overall Survival|Determine the median overall survival of BRAFV600E melanoma brain metastasis patients treated with SRS, trametinib and dabrafenib.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
1356066|NCT01721603|Secondary|Median Time to Progression|Determine the median time to progression in the brain of BRAFV600E melanoma brain metastases patients treated with SRS, trametinib and dabrafenib. RECIST v1.1 will be used as the primary determinant of disease progression. Disease response will be assessed at scheduled visits by MRI of the brain and clinical exam every two months thereafter. The proportion of patients that progression free at 6 months will be calculated.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
1356067|NCT01721603|Secondary|Median Duration of Freedom From New Brain Metastases( by RECIST v1.1 )|Determine median duration of freedom from new brain metastases of BRAFV600E melanoma brain metastases patients treated with SRS, trametinib and dabrafenib. RECIST v1.1 will be used as the primary determinant of disease progression.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
1356068|NCT01721603|Secondary|Best Overall Response Rate (by RECIST v1.1 )|Determine the best overall response rate (by RECIST v1.1 ).|From surgery up to 12 months||||Participants|||Count of Participants
1356069|NCT01721603|Secondary|Patients Displaying 6-month Local Control Rate|Determine whether dabrafenib combined with SRS and trametinib improves the 6-month local control rate of BRAFV600E melanoma brain metastases compared with historical controls treated with SRS.|From surgery up to 6 months||||Participants|||Count of Participants
1356070|NCT01721603|Primary|Patients Reaching 6 Month Distant Brain Metastasis-free Survival (DBMFS)|Determine whether dabrafenib combined with stereotactic radiosurgery (SRS) and trametinib improves the 6 month DBMFS rate of BRAFV600E melanoma patients for whom the standard of care is stereotactic radiosurgery (≤4 brain lesions and no lesion > 3 cm) in comparison with similar historical controls treated with radiosurgery alone.|Up to 6 months after surgery||||Participants|||Count of Participants
1356071|NCT01721564|Secondary|Intravascular Ultrasound - Pulmonary Artery Wall Thickness|Change in intima-media thickness|baseline and 6 months||||percentage of baseline||Standard Deviation|Mean
1356072|NCT01721564|Primary|Acetylcholine Vascular Reactivity Response|Percent pulmonary flow change from baseline after acetylcholine|Baseline and 6 months||||percentage of baseline||Standard Deviation|Mean
1356073|NCT01721486|Secondary|Parental Satisfaction With Pain Control.|Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.|24 hours post hospital discharge.||||units on a scale||Inter-Quartile Range|Median
1356074|NCT01721486|Secondary|Incidence of Post-operative Vomiting|Percentage of subjects with at least one episode of post-operative vomiting|From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.||||Participants|||Count of Participants
1356075|NCT01721486|Secondary|FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.|At time of admission into PACU.||||units on a scale||Full Range|Median
1356076|NCT01721486|Primary|Total Pain Medication|All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.|From time of PACU admission until 24 hours post-operatively.|Only patients receiving rescue pain medication were analyzed.|||mg||Inter-Quartile Range|Median
1356077|NCT01721460|Secondary|Portion of Participants With Timely Return of the Neuronal Activity to Baseline|The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.|30 minutes after stopping drug administration|All participants that received sedation. As the activity did not return to baseline within the allocated time for the study (30 minutes), we report the portion of patients in which the activity returned to baseline within this time.|||Participants|||Count of Participants
1356078|NCT01721460|Secondary|Time to Recovery|The time it takes for the patient to become alert after drug administration is stopped.|20-60 minutes after stopping drug administration|All participants that received sedation.|||minutes||Standard Deviation|Mean
1356079|NCT01721460|Secondary|Change in Average Firing Pattern in the STN|We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.|20-35 minutes following drug administration|All participants that received sedation|||percentage change||Standard Error|Mean
1356080|NCT01721460|Primary|Change in Average Population Spiking Activity|"We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.~For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units."|20-35 minutes following drug administration|All participants had the normalized RMS of the electrical activity calculated during control period, and under maximal sedation, and the difference between the two was calculated and normalized.|||Percent change||Standard Deviation|Mean
1356087|NCT01721317|Secondary|Number of Participants With the Indicated Assessment Events of Suicidal Behavior, Suicidal Ideation or Non-suicidal Self Injurious Behavior Via the Columbia Suicide Severity Rating Scale (C-SSRS)|Prospective assessment of suicidality was conducted using the Columbia-Suicide Severity Rating Scale (C-SSRS), a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. C-SSRS data were only collected through Week 8 for the 6 randomized participants. Due to the study being prematurely terminated, there was not sufficient data to evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 4, Week 6 and Week 8|Safety Population|||Participants|||Number
1356172|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR|3 year post index procedure||||Participants|||Count of Participants
1356081|NCT01721408|Primary|Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population|The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The MITT population was defined as all randomized participants who received at least 1 dose of investigational product.|||percentage of participants||95% Confidence Interval|Number
1356082|NCT01721408|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.|From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)|Safety population included all participants who received at least 1 dose of investigational product. There was 1 participant (who was included in the safety population) had 7 AEs including 1 SAE which were identified after database release and were not reflected in the table.|||participants|||Number
1356083|NCT01721408|Secondary|Microbiological Response at the Subject Level in the ME Population at the TOC Assessment|The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria. n=number of participants with each microbiological response.|||percentage of participants||95% Confidence Interval|Number
1356084|NCT01721408|Secondary|Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population|The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria.|||percentage of participants||95% Confidence Interval|Number
1356085|NCT01721408|Primary|Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population|The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The CE population was defined as all clinical modified intent-to-treat (c-mITT) participants who satisfied clinical evaluability criteria and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1356086|NCT01721330|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.|6 weeks|One subject withdrew from the study before receiving study medication, so data from only two subjects was analyzed (one subject in each group). Therefore, means and standard deviations were not calculated.|||units on a scale|||Number
1356088|NCT01721317|Secondary|Change From Baseline in Post-void Residual (PVR) Urinary Bladder Ultrasound Volume|The change from Baseline in the PVR bladder ultrasound results was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase) and Week 18 (end of Maintenance Phase)|Safety Population||||||
1356089|NCT01721317|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|The change from Baseline in the following urinalysis parameters (urine occult blood, urine glucose, urine ketones and urine protein) were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356090|NCT01721317|Secondary|Change From Baseline in Urine Potential of Hydrogen (pH)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize ot evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356091|NCT01721317|Secondary|Change From Baseline in Urine Specific Gravity (USG)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356092|NCT01721317|Secondary|Change From Baseline in Creatinine Clearance|The change from Baseline in the indicated chemistry test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356093|NCT01721317|Secondary|Change From Baseline in BUN/Creatinine Ratio|The change from Baseline in the indicated chemistry tests was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356094|NCT01721317|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, Glucose, Magnesium, Phosphorus Inorganic, Bicarbonate and Urea/Blood Urea Nitrogen (BUN)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356095|NCT01721317|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid and Creatinine|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356096|NCT01721317|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyltransferase (GGT)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356097|NCT01721317|Secondary|Change From Baseline in Albumin and Total Protein|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356098|NCT01721317|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356099|NCT01721317|Secondary|Change From Baseline in Red Blood Cell (RBC) Count|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356100|NCT01721317|Secondary|Change From Baseline in Hematocrit|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356101|NCT01721317|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356102|NCT01721317|Secondary|Change From Baseline in the Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils, White Blood Cell (WBC) Count and Platelet Count|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356103|NCT01721317|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils and Red Blood Cell (RBC) Distribution Width|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356104|NCT01721317|Secondary|Change From Baseline in the QT Interval Using Bazett’s Correction (QTcB) and QT Interval Using Fridericia’s Correction (QTcF)|Change from Baseline in the QT interval using Bazett's correction (QTcB) and QT interval using Fridericia's correction were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356105|NCT01721317|Secondary|Change From Baseline in Heart Rate|Change from Baseline in heart rate was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356106|NCT01721317|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from Baseline in blood pressure was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356107|NCT01721317|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
1356108|NCT01721317|Secondary|Number of Participants With Early Study Discontinuation|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of participants with early study discontinuation.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population|||Participants|||Number
1356109|NCT01721317|Secondary|Number of Participants at Each Dose During the Maintenance Phase and Average Maintenance Dose Over All Participants|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the number of participants at each dose during the Maintenance Phase and the average maintenance dose over all participants. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 11 (start of Maintenance Phase) to Week 18 (end of Maintenance Phase)|Safety Population||||||
1356110|NCT01721317|Secondary|Incidence of New Seizure Types in Participants Without a History of These Seizure Types|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of new seizure types in participants without a history of these seizure types. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population: all randomized participants who receive >= 1 dose of study medication.||||||
1356111|NCT01721317|Secondary|Percent Change From Baseline in Functional Status (Epilepsy-related Worry and Activity Limitation) and Productivity (Missed Work or School) to the End of the Dose-Optimization Phase and the End of the Maintenance Phase|The effect of ezogabine/retigabine IR as an adjunctive treatment on health outcomes was to be evaluated on the basis of functional status and productivity. Participants were asked to complete the paper functional status diary to collect information to assess how the participant’s functional status is affected by their epilepsy symptoms. Participants were asked to rate their epilepsy-related worry, activity limitations, and productivity (missed work or school). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
1356112|NCT01721317|Secondary|Change From Baseline in the Number of Seizure Free Days for the Indicated Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and the Dose-Optimization + Maintenance Phase|The change in number of seizure free days during the Double-Blind period, the Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
1356113|NCT01721317|Secondary|Number of Seizure Free Participants for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|Participants without seizures during the interval of Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose-Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
1356114|NCT01721317|Secondary|Number of Par. Experiencing >=50% Reduction in 28-day Total Partial Seizure Frequency (POS) for the Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and Dose-Optimization + Maintenance Phase|Participants (par.) experiencing >= 50% reduction from Baseline to the end of the Double-Blind Phase in 28-day total POS were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population||||||
1356115|NCT01721317|Secondary|Percent Change in 28-day Total Partial Seizure Frequency (POS) for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in total partial seizure frequency during the Dose-Optimization Phase and Maintenance Phase. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
1356141|NCT01721109|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
1356116|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) Within Each Stratum From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The percent change in 28-day total POS frequency within each stratum (sodium channel blocker or non-sodium channel blocker) background antiepileptic drug (AED) was to be summarized as the supportive analysis. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population||||||
1356117|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in the total partial seizure frequency, which was recorded by participants in the daily seizure calendar. The total 28-day POS rate is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and who had >= 1 post-Baseline seizure diary day with >= 0 seizures recorded.||||||
1356118|NCT01721226|Secondary|Linkage to Community Care|At least 1 visit to health care provider in past 24 weeks/6 months|24 weeks||||Participants|||Count of Participants
1356119|NCT01721226|Primary|Plasma Viral Load Suppression|Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction|24 weeks|All study participants with available PVL data|||participants|||Number
1356120|NCT01721200|Secondary|Changes in Perceived Knowledge|Perceived knowledge and value clarity will be measured using two subscales from the well-validated Decisional Conflict Scale (66). Each subscale is composed of 3 items measured on 5-point agree scales. Scores are rescaled to range from 0 to 100. Higher scores reflect greater conflict (poorer outcomes).|8 weeks||||units on a scale||Inter-Quartile Range|Median
1356121|NCT01721200|Secondary|Changes in Willingness|Willingness: Patients’ propensity towards biologics will be measured using the choice predisposition scale (65): This item is coded on a 11-point scale anchored by “Not willing at all” and “Extremely willing” with “Unsure” at the midpoint (65). Higher scores reflect greater willingness.|8 weeks|Follow-up data not collected because of ceiling effect.||||||
1356122|NCT01721200|Secondary|Changes in Knowledge|Knowledge will be measured using the 20 True/False statements developed for the initial pre-post test study. The number of correct responses are summed to yield a knowledge score (possible range= 0-20). The item order was determined using a random-numbers generator.|8 weeks||||units on a scale||Inter-Quartile Range|Median
1356123|NCT01721200|Secondary|To Test Adherence to the Intervention|The session management system will record the time spent on each module visited within the tool to assess adherence.|8 weeks|These data were not collected.||||||
1356124|NCT01721200|Secondary|Acceptability to Physicians|"Acceptability to physicians will be assessed using four items coded on 5-point Frequency scales (1= None of the time and 5= All of the time) administered by the research assistant once all patient follow-up interviews have been completed:~Did the tool make it easier to talk about treatment with your patients?~Did the tool increase the amount of time you spent discussing therapy with your patients?~Did the tool decrease the amount of time you spent discussing therapy with your patients?~Did the tool improve the quality of informed consent for patients initiating biologics?"|8 weeks|Data not collected||||||
1356125|NCT01721200|Secondary|To Test Uptake|To test uptake and adherence to the intervention we will measure the proportion of patients randomized to the intervention who access the tool, complete the Best Worse Scaling exercise, print a handout, and use the handout during a follow-up visit with their rheumatologist (for subjects having a second visit within eight weeks). Note, subjects without access to a printer will have the opportunity to do so in the office.|8 weeks|Data not collected||||||
1356126|NCT01721200|Secondary|To Test Screening and Recruitment Procedures|To test screening and recruitment procedures we will measure the number of eligible patients, the number of patients excluded by each exclusion criterion, the number of patients referred by rheumatologists each week, and the proportion of patients who agree to participate.|8 weeks|Data not collected||||||
1356127|NCT01721200|Secondary|Use of Biologics|Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.|8 weeks||||Number of subjects|||Number
1356128|NCT01721200|Secondary|Patient-physician Communication|Patient-physician communication will be measured using the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness): a 20-item scale composed of two subscales which address the quality of risk communication (process measure) and the quality of the decision making process (outcome measure). Items are measured on a 5-point agree scales. The COMRADE is a includes two sub-scales (each composed of 10 items): one for risk communication (a process measure) and a second for confidence in decision (an outcome measure). Subscales are summed to generate a total score (Range 20-100). Higher scores reflect poorer outcomes.|8 weeks||||units on a scale||Standard Deviation|Mean
1356129|NCT01721200|Primary|The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks|We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.|2 weeks||||Percentage of subjects|||Number
1356142|NCT01721109|Secondary|Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48||Baseline; Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.|||log10 copies/mL||Standard Deviation|Mean
1356143|NCT01721109|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis||Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
1356130|NCT01721161|Secondary|Summary of BIIB033 Concentration|One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.|Up to 32 weeks|PK analysis population: all participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data on record. n=number of participants with a sample at given timepoint.|||µg/mL||Full Range|Median
1356131|NCT01721161|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|32 weeks|Safety population: all participants who received at least 1 dose of study treatment.|||participants|||Number
1356132|NCT01721161|Primary|Change in FF-VEP Latency at Week 24: Per-protocol Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS)-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||msec||Standard Error|Mean
1356133|NCT01721161|Secondary|Change in LCLA at Week 24: Per-protocol Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||letters on a chart||Standard Error|Mean
1356134|NCT01721161|Secondary|Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with an LCLA assessment at Baseline. LOCF imputation was used if Week 24 data were missing.|||letters on a chart||Standard Deviation|Mean
1356135|NCT01721161|Secondary|Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||µm||Standard Deviation|Mean
1356136|NCT01721161|Secondary|Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with a valid RGCL/IPL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.|||µm||Standard Deviation|Mean
1356137|NCT01721161|Secondary|Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||percentage change||Standard Error|Mean
1356138|NCT01721161|Secondary|Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) and a valid RNFL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.|||percentage change||Standard Error|Mean
1356139|NCT01721161|Primary|Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo). Last observation carried forward (LOCF) imputation was used if Week 24 data were missing.|||msec||Standard Error|Mean
1356140|NCT01721109|Secondary|Change From Baseline in CD4 Percentage at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in the Full Analysis Set with available data were analyzed.|||percentage||Standard Deviation|Mean
1356145|NCT01721109|Secondary|For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng•h/mL||Standard Deviation|Mean
1356146|NCT01721109|Secondary|For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI|Cmax is defined as the maximum concentration of drug.|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng/mL||Standard Deviation|Mean
1356147|NCT01721109|Secondary|For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng/mL||Standard Deviation|Mean
1356148|NCT01721109|Primary|Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)||Up to Week 48 plus 30 days|Safety Analysis Set: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1356149|NCT01721109|Primary|For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng•h/mL||Standard Deviation|Mean
1356150|NCT01721096|Secondary|Net Gain: In-stent, In-segment|Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain – late loss).|8 months post index procedure||||mm|Lesions|Standard Deviation|Mean
1356151|NCT01721096|Secondary|Late Loss(LL): In-stent, In-segment, Proximal, and Distal|Late loss is calculated as MLD post procedure – MLD at follow-up.|8 months post index procedure||||mm|Lesions|Standard Deviation|Mean
1356152|NCT01721096|Secondary|Acute Gain: In-stent, In-segment|The difference between post- and pre-procedural MLD.|8 months post index procedure||||mm|Lesions|Standard Deviation|Mean
1356153|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|8 months post index procedure|Number of participants analyzed includes the number available for QCA.|||percentage of DS|Number of lesion analyzed|Standard Deviation|Mean
1356154|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|Post procedure||||percentage of DS|Number of lesion analyzed|Standard Deviation|Mean
1356155|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Baseline||||percentage of DS|Number of lesion analyzed|Standard Deviation|Mean
1356156|NCT01721096|Secondary|Number of Participants Experiencing Bleeding||3 year post index procedure||||Participants|||Count of Participants
1356157|NCT01721096|Secondary|Number of Participants Experiencing Bleeding||2 year post index procedure||||Participants|||Count of Participants
1356158|NCT01721096|Secondary|Number of Participants Experiencing Bleeding||1 year post index procedure||||Participants|||Count of Participants
1356159|NCT01721096|Secondary|Number of Participants Experiencing Bleeding||8 months post index procedure||||Participants|||Count of Participants
1356160|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|3 year post index procedure||||Participants|||Count of Participants
1356161|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|2 year post index procedure||||Participants|||Count of Participants
1356162|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|1 year post index procedure||||Participants|||Count of Participants
1356163|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|8 months post index procedure||||Participants|||Count of Participants
1356164|NCT01721096|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|3 year post index procedure||||Participants|||Count of Participants
1356165|NCT01721096|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|2 year post index procedure||||Participants|||Count of Participants
1356166|NCT01721096|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|1 year post index procedure||||Participants|||Count of Participants
1356167|NCT01721096|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered a non-target vessel revascularization.|8 months post index procedure||||Participants|||Count of Participants
1356168|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|3 year post index procedure||||Participants|||Count of Participants
1356176|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|3 year post index procedure||||Participants|||Count of Participants
1356177|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|2 year post index procedure||||Participants|||Count of Participants
1356178|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|1 year post index procedure||||Participants|||Count of Participants
1356179|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|8 months post index procedure||||Participants|||Count of Participants
1356180|NCT01721096|Secondary|Number of Participants With Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|3 year post index procedure||||Participants|||Count of Participants
1356181|NCT01721096|Secondary|Number of Participants With Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|2 year post index procedure||||Participants|||Count of Participants
1356182|NCT01721096|Secondary|Number of Participants With Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|1 year post index procedure||||Participants|||Count of Participants
1356183|NCT01721096|Secondary|Number of Participants With Myocardial Infarction|The endpoint myocardial infarction includes ST-elevation MI, non ST-elevation MI, Q wave MI and non Q wave MI|8 months post index procedure||||Participants|||Count of Participants
1356184|NCT01721096|Secondary|Number of Participants Experiencing Death|Death includes cardiac death, non-cardiac death and non-coronary death.|3 year post index procedure||||Participants|||Count of Participants
1356185|NCT01721096|Secondary|Number of Participants Experiencing Death|Death includes cardiac death, non-cardiac death and non-coronary death.|2 year post index procedure||||Participants|||Count of Participants
1356186|NCT01721096|Secondary|Number of Participants Experiencing Death|Death includes cardiac death, non-cardiac death and non-coronary death.|1 year post index procedure||||Participants|||Count of Participants
1356187|NCT01721096|Secondary|Number of Participants Experiencing Death|Death includes cardiac death, non-cardiac death and non-coronary death.|8 months post index procedure||||Participants|||Count of Participants
1356188|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI||3 year post index procedure||||Participants|||Count of Participants
1356189|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI||2 year post index procedure||||Participants|||Count of Participants
1356190|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI||1 year post index procedure||||Participants|||Count of Participants
1356191|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI||8 months post index procedure||||Participants|||Count of Participants
1356192|NCT01721096|Secondary|Number of Participants With Cardiac Death or MI||3 year post index procedure||||Participants|||Count of Participants
1356193|NCT01721096|Secondary|Number of Participants With Cardiac Death or MI||2 year post index procedure||||Participants|||Count of Participants
1356194|NCT01721096|Secondary|Number of Participants With Cardiac Death or MI||1 year post index procedure||||Participants|||Count of Participants
1356195|NCT01721096|Secondary|Number of Participants With Cardiac Death or MI||8 months post index procedure||||Participants|||Count of Participants
1356196|NCT01721096|Secondary|Number of Participants With Death or MI||3 year post index procedure||||Participants|||Count of Participants
1356197|NCT01721096|Secondary|Number of Participants With Death or MI||2 year post index procedure||||Participants|||Count of Participants
1356198|NCT01721096|Secondary|Number of Participants With Death or MI||1 year post index procedure||||Participants|||Count of Participants
1356199|NCT01721096|Secondary|Number of Participants With Death or MI||8 months post index procedure||||Participants|||Count of Participants
1356200|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|3 year post index procedure||||Participants|||Count of Participants
1356201|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|2 year post index procedure||||Participants|||Count of Participants
1356202|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|1 year post index procedure||||Participants|||Count of Participants
1356203|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|8 months post index procedure||||Participants|||Count of Participants
1356204|NCT01721096|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||percentage of participants|||Number
1356205|NCT01721096|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||percentage of participants|||Number
1356206|NCT01721096|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
1356207|NCT01721096|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||percentage of participants|||Number
1356208|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)||3 year post index procedure||||percentage of participants|||Number
1356209|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)||2 year post index procedure||||percentage of participants|||Number
1356210|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)||1 year post index procedure||||Participants|||Count of Participants
1356211|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)||8 months post index procedure||||Participants|||Count of Participants
1356212|NCT01721096|Secondary|Number of Participants With Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|3 years post index procedure||||Participants|||Count of Participants
1356213|NCT01721096|Secondary|Number of Participants With Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|2 year post index procedure||||Participants|||Count of Participants
1356214|NCT01721096|Secondary|Number of Participants With Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|1 year post index procedure||||Participants|||Count of Participants
1356215|NCT01721096|Secondary|Number of Participants With Target Lesion Failure|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|8 months post index procedure||||Participants|||Count of Participants
1356216|NCT01721096|Secondary|Success Rate: Percentage of Participants With Implant Success by Patient||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||percentage of participants||95% Confidence Interval|Number
1356217|NCT01721096|Secondary|Success Rate: Percentage of Participants With Procedural Success by Lesion||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||percentage of participants|Lesions|95% Confidence Interval|Number
1356218|NCT01721096|Secondary|Success Rate: Percentage of Participants With Implant Success Rate by Device||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||percentage of participants|XIENCE PRIME stents|95% Confidence Interval|Number
1356219|NCT01721096|Primary|Total Number of Participants With Overall Stent Thrombosis|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
1356220|NCT01721096|Primary|Number of Participants With Late Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Late (>30 days to 1 year)|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
1356237|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. “ACR50 Responder” is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:~Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders."|Week 12, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1356221|NCT01721096|Primary|Number of Participants With Subacute Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Subacute (>24 hours to 30 days)|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
1356222|NCT01721096|Primary|Number of Participants With Acute Stent Thrombosis (ST)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Time Frame: Acute (0-24 hours)|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
1356223|NCT01721070|Primary|Cmax|Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||pg/mL||Standard Deviation|Mean
1356224|NCT01721070|Primary|AUC (0-inf)|Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1356225|NCT01721057|Secondary|Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104||Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||nanograms per mL per hour (ng/mL*h)||Geometric Coefficient of Variation|Geometric Mean
1356226|NCT01721057|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104||Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1356227|NCT01721057|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 12; Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.|||percentage of impairment||Standard Deviation|Mean
1356228|NCT01721057|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||mm||Standard Deviation|Mean
1356229|NCT01721057|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1356287|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)|Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1356230|NCT01721057|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 12; Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1356231|NCT01721057|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1356232|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission – Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1356233|NCT01721057|Secondary|Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1356234|NCT01721057|Secondary|Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score|The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1356235|NCT01721057|Secondary|Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score|• The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF) .|||units on a scale||Standard Deviation|Mean
1356236|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. “ACR70 Responder” is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.|Week 12, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1356246|NCT01721044|Secondary|Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomoles*hour/Liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1356238|NCT01721057|Secondary|Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
1356239|NCT01721057|Secondary|Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine. Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
1356240|NCT01721057|Secondary|Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents no joint stiffness and 10 represents joint stiffness as bad as you can imagine. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
1356241|NCT01721057|Secondary|Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||minutes||95% Confidence Interval|Median
1356242|NCT01721057|Secondary|Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1356243|NCT01721057|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||units on a scale||Standard Deviation|Mean
1356244|NCT01721057|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do])when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||units on a scale||Standard Deviation|Mean
1356245|NCT01721057|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders."|Week 12|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).|||percentage of participants|||Number
1356283|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio|Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects|||mg/g||Standard Error|Least Squares Mean
1356247|NCT01721044|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib||Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data. Participants who initially received 2 mg with renal impairment were randomized to 4mg (N=11). Participants starting on 4mg (N=177) and participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.|||nanomoles/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1356248|NCT01721044|Secondary|Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized.|||Percentage of Impairment||Standard Deviation|Mean
1356249|NCT01721044|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent’s health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
1356250|NCT01721044|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Units on a Scale||Standard Deviation|Mean
1356251|NCT01721044|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores|The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
1356252|NCT01721044|Secondary|Change From Baseline in Worst Joint Pain NRS|Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
1356253|NCT01721044|Secondary|Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)|A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
1356284|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile|Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).|Week 0, up to week 104|Full analysis set included all randomised subjects.|||mg/dL||Standard Error|Least Squares Mean
1356254|NCT01721044|Secondary|Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Minutes||95% Confidence Interval|Median
1356255|NCT01721044|Secondary|Percentage of Participants Achieving ACR/EULAR Remission – Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
1356256|NCT01721044|Secondary|Change From Baseline in Measures of SDAI Score|"The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.~The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement."|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
1356257|NCT01721044|Secondary|Change From Baseline in Clinical Disease Activity Index Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
1356258|NCT01721044|Secondary|Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)|DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).|||Units on a Scale||Standard Deviation|Mean
1356259|NCT01721044|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 12 and Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
1356260|NCT01721044|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 12 and Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
1356285|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight|Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects. As specified in the protocol, the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||kg||Standard Error|Least Squares Mean
1356261|NCT01721044|Secondary|Percentage of Participants Achieving ACR20 Response|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 24|Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
1356262|NCT01721044|Secondary|Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg|The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.|Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of Participants|||Number
1356263|NCT01721044|Secondary|Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg|DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||Units on a Scale||Standard Deviation|Mean
1356264|NCT01721044|Secondary|Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||Units on a Scale||Standard Deviation|Mean
1356265|NCT01721044|Secondary|Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 12|Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
1356266|NCT01721044|Secondary|Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg|The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.|Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of Participants|||Number
1356267|NCT01721044|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg|DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||Units on a Scale||Standard Deviation|Mean
1356286|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose|Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects.|||mmol/L||Standard Error|Least Squares Mean
1356268|NCT01721044|Secondary|Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||Units on a Scale||Standard Deviation|Mean
1356269|NCT01721044|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire – Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.|Week 12|Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).|||Percentage of Participants|||Number
1356270|NCT01720797|Primary|Tooth Movement Between the Groups|"Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.~Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement."|6 months||||percentage of movement||Standard Deviation|Mean
1356271|NCT01720602|Secondary|Overall Survival|Kaplan-Meier survival curves will be used to describe overall survival.|Up to 5 years|||||||
1356272|NCT01720602|Secondary|Progression-free Survival (PFS)|Kaplan-Meier survival curves will be used to describe PFS.|Up to 5 years|||||||
1356273|NCT01720602|Secondary|Duration of Response|Duration of response will be summarized for responders.|Up to 5 years||||weeks||Full Range|Median
1356274|NCT01720602|Primary|Response Rate According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the response rate.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks||||percentage of patients||90% Confidence Interval|Number
1356275|NCT01720602|Primary|Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks||||percentage of patients||90% Confidence Interval|Number
1356276|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)|Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).|Week 0, up to week 104|Full analysis set included all the randomised subjects.|||beats/min||Standard Error|Least Squares Mean
1356277|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)|Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).|Week 0, up to week 104|Full analysis set included all randomised subjects.|||mmol/L||Standard Error|Least Squares Mean
1356278|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)|Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0−100 scale with higher scores indicating greater health related quality of life.|Week 0, up to week 104|Full analysis set included all randomised subjects.|||Scores on a scale||Standard Error|Least Squares Mean
1356279|NCT01720446|Secondary|Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies|The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.|Weeks 0-109|Full analysis set included all randomised subjects|||Percentage of subjects|||Number
1356280|NCT01720446|Secondary|Incidence During the Trial in Other Treatment Outcomes: Adverse Events|Rates (event rate per 100 years of exposure) of treatment emergent adverse events.|Weeks 0-109|Full analysis set included all randomised subjects.|||Event rate per 100 years of exposure|||Number
1356281|NCT01720446|Secondary|Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events|Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0 - 109|Full analysis set included all randomised subjects.|||Event rate per 100 exposure years|||Number
1356282|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs|Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).|Week 0, up to week 104|Full analysis set included all the randomised subjects.|||mmHg||Standard Error|Least Squares Mean
1356288|NCT01720446|Secondary|Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke|Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
1356289|NCT01720446|Secondary|Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome|Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
1356290|NCT01720446|Secondary|Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome|Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
1356291|NCT01720446|Primary|Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
1356292|NCT01720316|Secondary|Auditory Evoked Potentials - P50 Ratio (P50 S2/P50 S1 Amplitude) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials amplitude: P50 ratio (S2/S1). Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||ratio|||Number
1356293|NCT01720316|Secondary|Auditory Evoked Potentials in Gammas Oscillations (the Power Spectrum is Measured in Microvolts Squared) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials gamma: G40 hz phase locking at fz and cz; G20 hz phase locking response at fz and cz G30 hz phase locking response at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||microvolts squared|||Number
1356294|NCT01720316|Secondary|Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2 amplitude; mismatch negativity (MMN) at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||microvolts|||Number
1356295|NCT01720316|Secondary|Change in Magnocellular Pathway Function on Glycine Compared With Baseline. No Data Were Collected.|functional magnetic resonance imaging|6 weeks per treatment arm|Data not collected.||||||
1356296|NCT01720316|Secondary|Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE|Auditory evoked potentials latency: P300 at fz, cz, and pz); N100 at fz and cz); P200 at fz and cz. Participants were assessed at baseline and in week of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||msec|||Number
1356297|NCT01720316|Secondary|Brain GABA Metabolite Levels (GABA/Creatine Ratio: GABA/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Magnetic resonance spectroscopy GABA/Cr. Participants were assessed 1) pre-glycine treatment (baseline) and 2) in week 6 of open-label glycine treatment measured in posterior occipital cortex.|Baseline and week 6 of glycine||||ratio|||Number
1356298|NCT01720316|Secondary|Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|magnetic resonance spectroscopy - glutamate metabolite level. Participants were assessed 1) pre-glycine treatment and in week 6 of open-label glycine treatment. Measured in posterior occipital cortex.|baseline and week 6 of glycine||||ratio|||Number
1356299|NCT01720316|Secondary|Brain Glycine/CR Ratio|magnetic resonance spectroscopy: glycine/creatine ratio. Participants were assessed at 1) BASELINE PRE-GLYCINE TREATMENT: pre-glycine challenge drink, 60 minutes post challenge drink, 80 minutes post challenge drink, 100 minutes post challenge drink, and 120 minutes post challenge drink (0.4 g/kg up to max of 30 g); and 2) IN WEEK 6 OF OPEN-LABEL GLYCINE TREATMENT: pre-glycine dose, and 60 minutes, 80 minutes, 100 minutes and 120 minutes post daily dose of glycine. Measured in posterior occipital cortex|baseline (pre-challenge, 60, 80, 100, 120 minutes post-challenge), and week 6 of glycine (pre-dose and 60, 80, 100, 120 minutes post-dose||||ratio|||Number
1356328|NCT01719861|Primary|Overall Response Rate (ORR)|Overall response rate (ORR) was assessed as the number of patients who achieve either a partial (PR) or complete response (CR) measured by CT scans and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria, divided by the total number of patients treated on the study. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|6 weeks|All patients who were enrolled and started therapy.|||percentage of participants|||Number
1356300|NCT01720316|Primary|Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Hamilton Depression Scale measures severity of depression symptoms. The sum of ratings for 9 depression symptoms are measured on a scale from 0-2 with 0 meaning no symptoms and 2 meaning some level of severity of that specific symptom. The rating for 1 depression symptom is measured on a scale from 0-3 with 0 meaning no symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms are measured on a scale from 0-4 with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period||||units on a scale|||Number
1356301|NCT01720316|Primary|Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of ratings for 7 symptoms of mania is measured on a scale from 0-4 and the sum of 4 symptoms of mania is measured on a scale from 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period||||units on a scale|||Number
1356302|NCT01720316|Primary|Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Clinical Global Impression (CGI) therapeutic effect scores measure degree of improvement as marked (1), moderate (5), minimal (9) or unchanged/worse (13).|at 2 weeks, 4 weeks, and 6 weeks within each treatment period||||score|||Number
1356303|NCT01720316|Primary|Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Clinical Global Impression (CGI) severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|CGI at baseline and at 2 weeks, 4 weeks, and 6 weeks per treatment period||||units on a scale|||Number
1356304|NCT01720316|Primary|Brief Psychiatric Rating Scale (BPRS) Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Positive and Negative Symptom Scores at Baseline and at 2, 4, and 6 Weeks During Intervention 1, Intervention 2, and During Open-label Glycine|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within and after each treatment period||||units on a scale|||Number
1356305|NCT01720316|Primary|Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine|Plasma glycine levels; normal range is 122-467 nM/mL|At baseline, during glycine treatment, during placebo treatment and during open-label glycine||||nM/mL|||Number
1356306|NCT01720316|Primary|Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine|Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution; standard deviation of 10. Only overall composite score is entered.|At baseline, during glycine treatment, during placebo treatment and during open-label glycine|Data provided for each participant separately.|||units on a scale|||Number
1356307|NCT01720316|Primary|Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms are measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment period||||units on a scale|||Number
1356308|NCT01720277|Other Pre-specified|Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size|This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine|1 year|Nursing home facilities randomized to receive high dose or standard dose vaccine.|||Nursing Homes|Nursing Homes||Number
1356309|NCT01720277|Secondary|Change in Residents’ Functional Status|The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.|1 year||||Participants|||Count of Participants
1356310|NCT01720277|Primary|Total All-cause Hospitalizations|The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).|1 year|We identified long-stay nursing home residents and evaluated outcomes (e.g. hospitalizations, functional status).|||events|||Number
1356311|NCT01720251|Other Pre-specified|Immunological Markers: Specific IgE and IgG4|blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4|before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013|||||||
1356312|NCT01720251|Secondary|Safety and Tolerability|Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject|from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks|||||||
1356313|NCT01720251|Secondary|Quality of Life|mini-RQLQ questionnaires|up to 6 weeks during the birch pollen season 2013|||||||
1356329|NCT01719757|Secondary|Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject|The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.|4 weeks|Intent to treat analysis set(Last observational carried forward)|||participants|||Number
1356330|NCT01719757|Secondary|Change of Constipation Assessment From Baseline to Visit 2(End Visit)|Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)|4 weeks|Intent to treat analysis set(Last observational carried forward)|||score||Standard Deviation|Mean
1356314|NCT01720251|Primary|Combined Rhinoconjunctivitis Symptom and Medication Score|"The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.~The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2"|up to 6 weeks during the birch pollen season 2013||||score (maximum=3)||Standard Deviation|Mean
1356315|NCT01720173|Other Pre-specified|Pre-treatment Plasma Concentration Levels of VEGF, BMP9, BMP10, and ALK1|Associated with measures of clinical response to treatment, including PFS and OS.|Baseline|||||||
1356316|NCT01720173|Other Pre-specified|IHC Expression Levels of VEGF, FGF, TGFB, ALK1, CD105 and Other Markers|Associated with measures of clinical response to treatment, including PFS and OS.|Baseline|||||||
1356317|NCT01720173|Other Pre-specified|Gene Expression Levels of ALK1 and Other Markers|Associated with measures of clinical response to treatment, including PFS and OS.|Baseline|||||||
1356318|NCT01720173|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.|Eligible and treated participants|||months||95% Confidence Interval|Median
1356319|NCT01720173|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated participants.|||months||95% Confidence Interval|Median
1356320|NCT01720173|Primary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
1356321|NCT01720173|Primary|Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||Participants|||Count of Participants
1356322|NCT01720173|Primary|Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry|Percentage of participants who survive progression-free for at least 6 months without non-protocol therapy after study entry. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|Every other cycle for first 6 months|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
1356323|NCT01720043|Primary|Efficacy of Velcade|Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.|48 hours|One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.|||percentage||Standard Deviation|Mean
1356324|NCT01719861|Secondary|Median Overall Survival (OS)|Median overall survival was defined as time from enrollment to death from any cause calculated using the Kaplan-Meier method.|From start of enrollment until death, no limit|All patients who were enrolled and started therapy.|||Months||Full Range|Median
1356325|NCT01719861|Secondary|Progression-free Survival (PFS), Median|Median PFS was defined as the time from randomization to disease progression (or death if the patient died before progression) calculated using the Kaplan-Meier method.|Up to 5 years from enrollment to radiographic progression or drug discontinuation|All patients who were enrolled and started therapy.|||Months||Full Range|Median
1356326|NCT01719861|Secondary|Median Serum Desipramine Levels During Treatment|"Median serum desipramine levels during treatment is reported as the median of the maximum steady state serum concentration observed in all patients.~Therapeutic concentration of desipramine is 100 to 300 ng/mL, and toxic concentration is > 300 ng/mL."|Up to 6 weeks|All patients who were enrolled and started therapy.|||ng/mL||Full Range|Median
1356327|NCT01719861|Secondary|Desipramine Maximum Dose|Assessed as the median per patient maximum dose (MD) using intra-patient dose escalation, and reported as the highest dose of desipramine administered continuously for 1 week or greater.|Up to 6 weeks|All patients who were enrolled and started therapy.|||mg daily||Full Range|Median
1356331|NCT01719757|Secondary|Change of Eastern Cooperative Oncology Group(ECOG) Performance Status|"If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse.~ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death."|4weeks|Intent to treat analysis set: 304|||Score||Standard Deviation|Mean
1356332|NCT01719757|Primary|Change in Numeric Rating Scales (NRS) Score|Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).|4 weeks|Intent to treat analysis set: 304|||units on a scale||Standard Deviation|Mean
1356333|NCT01719744|Secondary|Number of Certain Biomarkers in Participants Compared to Progression Free Survival.||2 years||2017-12-31|12/2017||||
1356334|NCT01719744|Secondary|Objective Response Rate|"Objective Response Rate (ORR) = CR+ PR. ORR is evaluated per RECIST v1.1 criteria.~Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions."|From start of study treatment until disease progression or death, whichever occurs first.||||percentage of participants||95% Confidence Interval|Number
1356335|NCT01719744|Secondary|Number of and Severity of Adverse Events Per Participant|Number of participants who experienced a grade 3 or higher adverse event. Reporting threshold 5%|2 years||||participants|||Number
1356336|NCT01719744|Primary|6-month Progression-free Survival Rate (PFS)|Number of patients with no progression of disease at 6 months|From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.||||participants||95% Confidence Interval|Number
1356337|NCT01719653|Secondary|Adequate/Inadequate Scale|The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.|At completion of colonoscopy - day 1||||Participants|||Count of Participants
1356338|NCT01719653|Secondary|Boston Bowel Preparation Scale|The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).|At completion of colonoscopy - day 1||||units on a scale||Standard Deviation|Mean
1356339|NCT01719653|Primary|Chicago Bowel Preparation Scale|The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).|At completion of colonoscopy - day 1||||units on a scale||Standard Deviation|Mean
1356340|NCT01719224|Secondary|Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients|Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.|48 hours after delivery||||cm^2||Standard Deviation|Mean
1356341|NCT01719224|Primary|Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep|We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.|48 hours after delivery|55 women (older than 18 years) were recruited within 48 h after delivery. Polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.|||Apneas and hypopneas per hour of sleep||Standard Error|Mean
1356342|NCT01719172|Secondary|Median Time to Achieve Hemostasis|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)||||Minutes||95% Confidence Interval|Median
1356343|NCT01719172|Secondary|Proportion of Subjects Who Achieve Hemostasis Within 1 Minute|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)||||participants|||Number
1356344|NCT01719172|Primary|Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment|Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)||||participants|||Number
1356345|NCT01719003|Secondary|Body Weight Change From Baseline at Week 24|"Change from baseline in body weight (kg) after 24 weeks of treatment.~“Baseline” refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)|||kg||Standard Error|Mean
1356346|NCT01719003|Secondary|FPG (Fasting Plasma Glucose) Change From Baseline at Week 24|"Change from baseline in FPG (mg/dL) after 24 weeks of treatment.~“Baseline” refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)|||mg/dL||Standard Error|Mean
1356347|NCT01719003|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24|"Change from baseline in HbA1c (%) after 24 weeks of treatment.~“Baseline” refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means"|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)|||percentage of HbA1c||Standard Error|Mean
1356348|NCT01718691|Secondary|Laboratory Test Abnormalities (Hematology Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks||||participants|||Number
1356349|NCT01718691|Secondary|Laboratory Test Abnormalities (Biochemical Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks||||participants|||Number
1356350|NCT01718691|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.|up to 30 weeks||||participants|||Number
1356351|NCT01718691|Secondary|Overall Survival (OS)|Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood’s formula.|Up to 30 weeks||||days||95% Confidence Interval|Median
1356352|NCT01718691|Secondary|Duration of Response (DOR)|"DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood’s formula.~The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).~Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause."|Up to 30 weeks||||days||95% Confidence Interval|Median
1356353|NCT01718691|Secondary|Progression-Free Survival (PFS)|"PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood’s formula.~Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response)."|Up to 30 weeks||||days||95% Confidence Interval|Median
1356354|NCT01718691|Secondary|"Overall Response Rate (PR or Better) Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)"|"The criteria for Overall response rate (PR or better) based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.~Definition of PR:~Measurable disease:~50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.~Unmeasurable disease:~Estimated decrease in tumor size of 50% or more for at least 4 weeks.~Bone metastases:~Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks."|Up to 30 weeks||||percentage of participants|||Number
1356355|NCT01718691|Secondary|Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)|"The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.~Measurable disease:~The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.~Unmeasurable disease:~Complete disappearance of all known disease for at least 4 weeks.~Bone metastases:~Complete disappearance of all lesions on X-ray or scan for at least 4 weeks."|Up to 30 weeks||||percentage of participants|||Number
1356356|NCT01718691|Secondary|Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for PR based on the Revised RC are shown below.~Definition: Regression of measurable disease and no new sites~Nodal Masses:~50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT~Spleen, Liver:~50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen~Bone Marrow:~Irrelevant if positive prior to therapy; cell type should be specified."|Up to 30 weeks||||percentage of participants|||Number
1356357|NCT01718691|Secondary|Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for CR based on the Revised RC are shown below.~Definition: Disappearance of all evidence of disease~Nodal Masses:~[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.~Variably FDG-avid or PET negative; regression to normal size on CT.~Spleen, Liver:~Not palpable, nodules disappeared~Bone Marrow:~Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative."|Up to 30 weeks||||percentage of participants|||Number
1356358|NCT01718691|Secondary|Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for PR based on IWRC are shown below.~PR: SPD regressed > 50%"|Up to 30 weeks||||percentage of participants|||Number
1356359|NCT01718691|Primary|Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for CR and CRu based on IWRC are shown below.~CR: Fulfills all of the following~Disappearance of all detectable disease~LN* > 1.5 cm must decrease to ≤ 1.5 cm~CRu: Fulfills all of the following~LN >1.5 cm; SPD** decrease >75%~indeterminate bone marrow~LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters"|Up to 30 weeks||||percentage of participants|||Number
1356360|NCT01718535|Primary|Percent Agreement|The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.|After second pass result is complete (~3hours)||||Percent Agreement||95% Confidence Interval|Number
1356361|NCT01718509|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|Safety Analysis Set|||units on a scale||Standard Deviation|Mean
1356362|NCT01718509|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 12 weeks|Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. All subjects from Site 015 were excluded from the Safety Analysis Set.|||participants|||Number
1356363|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
1356364|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
1356365|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
1356366|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
1356367|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
1356368|NCT01718509|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks|The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from “1” (almost never) to “5” (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.|Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||t-scores||Standard Error|Least Squares Mean
1356369|NCT01718509|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and week 12|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
1356370|NCT01718509|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.|Baseline and week 12|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
1356371|NCT01718509|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12||Baseline and Visit 8 Which Spans Weeks 11/12|Full Analysis Set.|||Binge episodes per week||Standard Error|Least Squares Mean
1356372|NCT01718509|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows:~1-week Cessation = 100% reduction in binge episodes during the preceding 7 days~Marked Reduction = 99% to 75% reduction during the time since the previous visit~Moderate Reduction = 74% to 50% reduction during the time since the previous visit~Negative to Minimal Reduction = <50% reduction during the time since the previous visit"|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
1356373|NCT01718509|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||Percent||Standard Error|Least Squares Mean
1356374|NCT01718509|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||mmol/L||Standard Error|Least Squares Mean
1356375|NCT01718509|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||mmol/L||Standard Error|Least Squares Mean
1356376|NCT01718509|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and week 12|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
1356377|NCT01718509|Secondary|Percent Change From Baseline in Body Weight (kg) at Week 12||Baseline and week 12|Full Analysis Set.|||percentage change||Standard Error|Least Squares Mean
1356378|NCT01718509|Secondary|Percent of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1356379|NCT01718509|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1356380|NCT01718509|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.|Baseline and Visit 8 Which Spans Weeks 11/12|The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).|||Binge days per week||Standard Error|Least Squares Mean
1356381|NCT01718483|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.|||units on a scale||Standard Deviation|Mean
1356382|NCT01718483|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Number of participants with suicidal ideation and suicidal behavior were reported.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.|||participants|||Number
1356383|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
1356384|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
1356385|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
1356386|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
1356387|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
1356388|NCT01718483|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12|The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from “1” (almost never) to “5” (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||t-scores||Standard Error|Least Squares Mean
1356389|NCT01718483|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||units on a scale||Standard Error|Least Squares Mean
1356390|NCT01718483|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|"The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake).~Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger."|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||units on a scale||Standard Error|Least Squares Mean
1356391|NCT01718483|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)||Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||Binge episodes per week||Standard Error|Least Squares Mean
1356392|NCT01718483|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows:~1-week Cessation = 100% reduction in binge episodes during the preceding 7 days.~Marked Reduction = 99% to 75% reduction during the time since the previous visit.~Moderate Reduction = 74% to 50% reduction during the time since the previous visit.~Negative to Minimal Reduction = <50% reduction during the time since the previous visit."|Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
1356393|NCT01718483|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||Percent hemoglobin||Standard Error|Least Squares Mean
1356394|NCT01718483|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||mmol/L||Standard Error|Least Squares Mean
1356395|NCT01718483|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and Week 12/Early termination (ET)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1356396|NCT01718483|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||units on a scale||Standard Error|Least Squares Mean
1356397|NCT01718483|Secondary|Percent Change From Baseline in Body Weight at Week 12||Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||percent change||Standard Error|Least Squares Mean
1356398|NCT01718483|Secondary|Percentage of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||percentage of participants||95% Confidence Interval|Number
1356399|NCT01718483|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||percentage of participants||95% Confidence Interval|Number
1356421|NCT01717989|Secondary|Percentage of Participants Receiving a Vitamin D Sterol|The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
1356400|NCT01718483|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.|Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||Binge days per week||Standard Error|Least Squares Mean
1356401|NCT01718353|Primary|Drug-target Engagement in CTCs: Change From Baseline at Cycle 1 Day 8 in MTB by Categories of PSA Decrease From Baseline (≥30%, Not ≥30%) After Cycle 4|Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained AR nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced MTB. Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. MTB in images of CTCs captured by GEDI was qualitatively assessed by three independent operators for increase compared with baseline on a scale of 0 to 3 from no to most MTB increase. Increase from baseline in MTB may indicate inhibition of AR signaling. Change from baseline in MTB at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥30%, Not ≥30%) after Cycle 4.|Baseline and Cycle 1 Day 8, Cycle 4|Participants with evaluable CTCs at both baseline and Cycle 1 Day 8, and evaluable PSA result at both baseline and Cycle 4|||units on a scale||Standard Deviation|Mean
1356402|NCT01718353|Secondary|Percentage of Participants With ≥30% and ≥50% Reduction in PSA Response|Participants with ≥30% and ≥50% reduction in PSA response from base line were evaluated in participants who were previously treated with a high potency androgen receptor (AR)-targeted agent (AR signaling inhibitor or cytochrome P450 17 alphahydroxylase/17,20lyase [CYP 17] inhibitor).|From baseline until DP or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on as-treated population that included all participants who received initial taxane treatment and had a post treatment assessment. Number of participants analyzed=participants treated/non-treated with AR-target agent and with PSA response assessment at specified time-points.|||percentage of participants|||Number
1356403|NCT01718353|Secondary|Overall Survival|Overall survival before switch and overall survival during the study was defined as the time interval from the date of random allocation to the date of death due to any cause until study cut-off date.|From baseline until death due to any cause or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||Months||95% Confidence Interval|Median
1356404|NCT01718353|Secondary|Clinical Progression-free Survival (cPFS)|cPFS was assessed before switch and during the study including skeletal-related events (SRE), increasing pain requiring escalation of narcotic analgesics, urinary obstruction, etc. SRE included pathological fractures and/or spinal cord compression, need for bone irradiation (including radioisotopes or bone surgery), change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the face of increase in pain) to treat bone pain. Pain was assessed using present pain intensity (PPI) scale (0=no pain, up to 5=excruciating pain) and analgesics used for cancer pain (1 point for non-narcotic medications and 4 points for narcotic medications).|Baseline, Pre-dose every 3 weeks, EOT, every 3 months (for 1 year) until first SRE occurrence or death or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||months||95% Confidence Interval|Median
1356405|NCT01718353|Secondary|Radiographic Progression-free Survival (rPFS)||From baseline, every 12 weeks until radiological tumor progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||months||95% Confidence Interval|Median
1356406|NCT01718353|Secondary|Percentage of Participants With Objective Response||From baseline until DP or study cut off, whichever was earlier (Maximum duration: 60 weeks)|No data was collected to determine the Objective Response, hence this outcome measure was not evaluated.||||||
1356407|NCT01718353|Secondary|PSA Progression Free Survival|PSA progression-free survival before any switch and PSA progression free survival during the study was defined as the time interval between the date of Day 1 of Cycle 1 to the date of either first PSA progression or death due to any cause whichever came first. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart).|From Baseline until DP or death due to any cause or study cut off date, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized population.|||months||95% Confidence Interval|Median
1356408|NCT01718353|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of random allocation of the treatment and the date of first documentation of any of the following: radiographic tumor progression (using Modified Response Evaluation Criteria in Solid Tumors [RECIST1.1] before any switch and during the study), clinical progression (including skeletal-related events, increasing pain requiring escalation of narcotic analgesics, urinary obstruction), PSA progression or death from any cause. Analysis was performed by Kaplan Meier method.|From Baseline until DP or death due to any cause or study cut off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||months||95% Confidence Interval|Median
1356419|NCT01717989|Secondary|Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time|Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin < 10 g/dL: Faciities with 0 to <5% of participants with hemoglobin < 10 g/dL; Facilities with 5 to < 10% of participants with hemoglobin < 10 g/dL; Facilities with 10 to < 15% participants with hemoglobin < 10 g/dL; Facilities with 15 to < 20% of participants with hemoglobin < 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin < 10 g/dL.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities with at least one non-missing hemoglobin record, for participants included in the primary analysis set who were on study and with available data at each time point.|||percentage of facilities|Participants||Number
1356420|NCT01717989|Secondary|Mean Hemoglobin Concentration by Quarter||Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point and with available data.|||g/dL||Standard Deviation|Mean
1356409|NCT01718353|Primary|Drug-target Engagement in Circulating Tumor Cells (CTCs): Change From Baseline at Cycle 1 Day 8 in Percent Androgen Receptor Nuclear Localization (%ARNL) by Categories of PSA Decrease From Baseline (≥50%, Not ≥50%) After Cycle 4|Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained androgen receptor (AR) nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced microtubule bundling (MTB). Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. %ARNL was assessed by quantitative analysis of images of CTCs captured by geometrically enhanced differential immunocapture (GEDI). Reduction from baseline in %ARNL (percentage of total cellular AR that is located in the nucleus) may indicate inhibition of AR signaling. Change from baseline in %ARNL at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥50%, Not ≥50%) after Cycle 4.|Baseline and Cycle 1 Day 8, Cycle 4|Participants with evaluable CTCs at both baseline and Cycle 1 Day 8, and evaluable PSA result at both baseline and Cycle 4|||percentage ARNL||Standard Deviation|Mean
1356410|NCT01718353|Primary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease in PSA levels in both treatment arms from baseline, during the whole treatment, before treatment switch and after treatment switch. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart). Because the purpose of this study is to explore the benefit of a regimen in which participants are switched to a different taxane if PSA does not decrease ≥30% after 4 cycles, irrespective of which agent (docetaxel or cabazitaxel) is administered initially, the data for participants who began treatment with docetaxel and for those who began treatment with cabazitaxel were combined for the efficacy analyses.|Baseline, Pre-dose every 3 weeks, 30 days after last treatment administration (End of treatment [EOT]), every 3 months (for 1 year) then every 6 months until PSA progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||percentage of participants|||Number
1356411|NCT01718028|Secondary|Percent Change From Baseline in NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||percent change||Standard Deviation|Mean
1356412|NCT01718028|Secondary|Mean NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||seconds||Standard Deviation|Mean
1356413|NCT01718028|Secondary|Mean Change From Baseline in NITFBUT at Day 14|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||seconds||Standard Deviation|Mean
1356414|NCT01718028|Primary|Mean Change From Baseline in NITFBUT at Day 30|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||seconds||Standard Deviation|Mean
1356415|NCT01717989|Secondary|Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out||June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||participants|||Number
1356416|NCT01717989|Secondary|Number of Participants Taking Epoetin Alfa by Month|The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis at each time point.|||participants|||Number
1356417|NCT01717989|Secondary|Cumulative Monthly Dose of Epoetin Alfa Administered|The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.|||units||Inter-Quartile Range|Median
1356418|NCT01717989|Secondary|Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL|The mean percentage of participants per facility with transferrin saturation < 20% and ferritin level < 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
1356422|NCT01717989|Secondary|Percentage of Participants Receiving Phosphate Binding Agents|The percentage of participants receiving phosphate binding agents over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
1356423|NCT01717989|Secondary|Percentage of Participants Receiving Cinacalcet|The percentage of participants receiving cinacalcet (Sensipar) over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
1356424|NCT01717989|Secondary|Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)|The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set facilities / participants on study at each time point.|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
1356425|NCT01717989|Secondary|Percentage of Participants in Each Vascular Access Type Category|The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study and on hemodialysis at each time point|||percentage of participants|||Number
1356426|NCT01717989|Primary|Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%|"The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:~Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility."|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing URR record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
1356427|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin > 12 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin > 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
1356428|NCT01717989|Secondary|Percentage of Participants Treated by Each Dialysis Modality|The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
1356429|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin < 10 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin < 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
1356430|NCT01717976|Secondary|Total Costs to the VHA|Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit|180 days|0 out of 257 participants in the DISPO intervention group and 1 of 256 in the usual care group were deceased at 30 days and not included in the cost analysis.|||US Dollars||Standard Deviation|Mean
1356431|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|180 days|26 out of 257 in intervention group and 33 out of 256 participants in the usual care group had missing data at the 180 day interview for satisfaction due to missing the 180-day interview or non-response to the satisfaction question at the 180 day interview.|||Participants|||Count of Participants
1356432|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|30 days|24 out of 257 in intervention group and 38 out of 256 participants in the usual care group had missing data at the 30 day interview for satisfaction due to missing the 30-day interview or non-response to the satisfaction question at the 30 day interview.|||Participants|||Count of Participants
1356433|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|Baseline|0 out of 257 in intervention group and 2 out of 256 participants in the usual care group had missing data at baseline for satisfaction due to non-response.|||Participants|||Count of Participants
1356434|NCT01717976|Primary|Number of Participants Experiencing Repeat ED Use|Number of Participants Experiencing Repeat ED Use|30 days|0 out of the 257 participants in the DISPO intervention group and 1 of the 256 participants in the Usual Care group were deceased at 30 days and not included in the primary outcome analysis.|||Participants|||Count of Participants
1356435|NCT01717898|Other Pre-specified|Determination of Whether Specific Pathway Changes Are Predictive of Clinical Benefit (Improved PFS) or Resistance Prior to Treatment or During Treatment Using Microarray Analysis.||post study|||||||
1356436|NCT01717898|Other Pre-specified|Determination of Whether the Pre-treatment Status of pS6, pAKT, p4EBP1 and PTEN, Determined by IHC in the Optional Biopsies of Metastatic Tumors, Are Associated With Response to BEZ235 Plus Abiraterone Acetate/Prednisone.||post study|||||||
1356437|NCT01717898|Secondary|Safety of BEZ235 and Abiraterone Acetate Plus Prednisone When Used in Combination|Number of reported Adverse Events in BEZ235 and Abiraterone Acetate plus Prednisone when used in combination (Phase II).|Beginning of Phase II up to 15 months|No Adverse Events were collected in Phase II. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
1356438|NCT01717898|Secondary|Objective Response Rate (ORR) in Phase II|Proportion of patients achieving an objective response to BEZ235 + Abiraterone Acetate/prednisone according to RECIST criteria.|From beginning of Phase II up to 15 months|ORR could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
1356439|NCT01717898|Secondary|Determination of the Time to PSA Progression in Phase II|Determination of the time to PSA progression in Phase II based on PSAWG2 criteria.|Beginning of Phase II up to 15 months|Time to PSA progression could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
1356440|NCT01717898|Secondary|Progression Free Survival (PFS) in Phase II|Progression Free Survival (PFS) of the combination of BEZ235 plus Abiraterone Acetate/prednisone as determined by Prostate-Specific Antigen Working Group 2 criteria (PSAWG2 ) during Phase II.|Beginning of Phase II up to 15 months|PFS in Phase II could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
1356441|NCT01717898|Secondary|Trough Concentrations of BEZ235 and Abiraterone Acetate Plus Prednisone When Used in Combination|Trough concentrations of BEZ235 and Abiraterone Acetate plus Prednisone when used in combination during Phase I.|Beginning of study up to 15 months|Concentrations could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
1356442|NCT01717898|Primary|Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I).|Maximum Tolerated Dose (MTD) for BEZ235 + Abiraterone Acetate (to be determined during Phase I). The MTD of BEZ235 will be the dose when given in combination results in less than 33% dose limiting toxicities (DLT).|Beginning of study up to 15 months|Dose could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.|||Participants|||Count of Participants
1356443|NCT01717898|Primary|Response Proportion as Defined by a Decline in PSA of > 50%|"Response proportion as defined by a decline in PSA of > 50% following 12 weeks of therapy for patients treated with the combination of BEZ235 and Abiraterone Acetate plus Prednisone (Phase II outcome measure).~Study was terminated during Phase I, Dose level 1 due to toxicity, therefore no Phase II data is available."|From day 1 of therapy initiation up to 12 weeks|Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
1356444|NCT01717898|Primary|Anti-tumor Responses as Defined by a Decline in PSA of > 50%|Anti-tumor responses as defined by a decline in PSA of > 50% following 12 weeks of therapy to the combination of Abiraterone Acetate plus BEZ-235 occur in a cohort of patients who have received prior therapy with Abiraterone Acetate therapy|From day 1 of therapy initiation up to 12 weeks|Study was terminated during Phase I, Dose level 1 due to toxicity.|||Participants|||Count of Participants
1356445|NCT01717898|Primary|Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I).||Beginning of study up to 15 months|Study was terminated during Phase I, Dose level 1 due to toxicity.|||Participants|||Count of Participants
1356446|NCT01717872|Secondary|Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis|The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.|30 seconds||||percent of glottic opening||95% Confidence Interval|Mean
1356447|NCT01717872|Secondary|Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue|30 seconds||||percent of glottic opening||95% Confidence Interval|Mean
1356448|NCT01717872|Primary|The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue|30 seconds||||percentage of Glottic opening||95% Confidence Interval|Mean
1356449|NCT01717768|Other Pre-specified|AUC 0-24 Hrs After 120 mg Dose of TSX-002|AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).|||hr×ng/dL||Standard Deviation|Median
1356450|NCT01717768|Other Pre-specified|Cavg 0-24 Hrs (ng/dL) After 120 mg Dose|PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).|||ng/dL||Standard Deviation|Least Squares Mean
1356451|NCT01717768|Secondary|Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment|Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.|||percentage of subjects|||Number
1356452|NCT01717768|Primary|Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002|Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.|||percentage of participants|||Number
1356453|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.|||Number of participants|||Number
1356454|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.|||Number of subjects|||Number
1356455|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.|||Number of subjects|||Number
1356456|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.|From day 1 to day 7 after any vaccination|Analysis was done on the safety population.|||Number of subjects|||Number
1356457|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population.|||Number of subjects|||Number
1356458|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.|||Number of subjects|||Number
1356459|NCT01717638|Secondary|Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
1356460|NCT01717638|Secondary|GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Ratio||95% Confidence Interval|Geometric Mean
1356461|NCT01717638|Secondary|GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
1356462|NCT01717638|Secondary|Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.|"The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.~Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.~Immune sufficiency was not applicable for M10713 strain."|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
1356463|NCT01717638|Secondary|Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine|"The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.~Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer."|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
1356464|NCT01717638|Secondary|GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.|The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Ratio||95% Confidence Interval|Geometric Mean
1356933|NCT01712178|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Measured through Week 24||||Percentage of participants|||Number
1356465|NCT01717638|Secondary|GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
1356466|NCT01717638|Secondary|Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
1356467|NCT01717638|Secondary|Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity.|||Percentages of subjects||95% Confidence Interval|Number
1356468|NCT01717638|Secondary|Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Ratio||95% Confidence Interval|Geometric Mean
1356469|NCT01717638|Secondary|GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
1356470|NCT01717638|Secondary|Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.|||Percentages of subjects||95% Confidence Interval|Number
1356471|NCT01717638|Secondary|GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency.|||Ratio||95% Confidence Interval|Geometric Mean
1356472|NCT01717638|Secondary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.|Day 1 (22-36 months post last MenB vaccine; baseline for naive)|FAS, Persistency.|||Titers||95% Confidence Interval|Geometric Mean
1356473|NCT01717638|Secondary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.|||Percentages of subjects||95% Confidence Interval|Number
1356474|NCT01717638|Primary|Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.|Day 1 (24-36 months post booster dose; baseline for naive)|FAS, Persistency.|||Ratio||95% Confidence Interval|Geometric Mean
1356484|NCT01717456|Secondary|MHQ Sleep Energy at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1359957|NCT01680783|Secondary|Ventilator Days|Duration of mechanical ventilation via endotracheal tube|number of days in the hospital||2018-06-30|06/2018||||
1356475|NCT01717638|Primary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).|Day 1 (24-36 months post booster; baseline for naive)|FAS, Persistency.|||Titers||95% Confidence Interval|Geometric Mean
1356476|NCT01717638|Primary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|"The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.~The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA)."|Day 1 (24-36 months post booster; baseline for naive)|Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.|||Percentages of subjects||95% Confidence Interval|Number
1356477|NCT01717456|Other Pre-specified|Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment|"OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from No assistance needed in this area to Assistance needed, but no Caregivers available. Ordinal scale with 6 levels:~0= No assistance needed~Caregiver provides assistance~Caregiver needs training or support~Caregiver is unlikely to provide assistance~Unclear if caregiver will assist patient~Assistance is needed but is not available"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment|||units on a scale||Full Range|Median
1356478|NCT01717456|Other Pre-specified|Patient's Living Situation at End of Treatment|OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment|||participants|||Number
1356479|NCT01717456|Other Pre-specified|Depression Screening at End of Treatment|"OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:~0= No screening~Screened for depression with PHQ2 measure~Screened with PHQ2 and meets criteria for further evaluation of depression~Screened and does not meet criteria for further evaluation of depression"|End of Treatment (Week 6)|Analysis population consists of all patients providing data at end of treatment.|||participants|||Number
1356480|NCT01717456|Other Pre-specified|When is Patient Anxious at End of Treatment?|"OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:~0 - None of the time~- Less often than daily~- Daily, but not constantly~- All of the time"|End of Treatment (Week 6)|Analysis population consists of all patients who provided end of treatment data.|||units on a scale||Full Range|Median
1356481|NCT01717456|Other Pre-specified|Ability to Reach Toilet at End of Treatment|"OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.~A lower score is better.~Responses:~0. Able to get to and from the toilet and transfer independently with or without a device.~When reminded, assisted, or supervised by another person, able to get to and from the toilet.~Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).~Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.~Is totally dependent in toileting."|End of Treatment (Week 6)|All patients who provided data for this measure at the end of treatment.|||units on a scale||Full Range|Median
1356482|NCT01717456|Other Pre-specified|Change in Ambulation From Baseline to End of Treatment|"OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:~0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).~Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.~Able to walk only with the supervision or assistance of another person at all times.~Chairfast, unable to ambulate but is able to wheel self independently.~Chairfast, unable to ambulate and is unable to wheel self.~Bedfast, unable to ambulate or be up in a chair.~Higher scores represent improvement in ability to ambulate."|Baseline, End of Treatment (Week 6)|Analysis sample consists of all patients who provided data for this questionnaire at the end of treatment. Two EMB subjects did not provide this data for unknown reasons, and 4 SC subjects did not provide this data for unknown reasons.|||units on a scale||Full Range|Median
1356483|NCT01717456|Other Pre-specified|Cognitive Status at End of Treatment|"OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:~0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.~- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.~- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.~- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.~- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium."|End of Treatment (Week 6)|Analysis population is all patients who provided data on this measure at end of treatment. Data were missing for 2/11 in Group A and 6/8 in Group B.|||units on a scale||Full Range|Median
1356485|NCT01717456|Secondary|MHQ Sleep Energy at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356486|NCT01717456|Secondary|MHQ Emotions at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356487|NCT01717456|Secondary|MHQ Emotions at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356488|NCT01717456|Secondary|MHQ Personal Relationships at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356489|NCT01717456|Secondary|MHQ Personal Relationships at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356490|NCT01717456|Secondary|MHQ Social Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356491|NCT01717456|Secondary|MHQ Social Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356492|NCT01717456|Secondary|MHQ Physical Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356493|NCT01717456|Secondary|MHQ Physical Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356494|NCT01717456|Secondary|MHQ Role Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356495|NCT01717456|Secondary|MHQ Role Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356496|NCT01717456|Secondary|MHQ Incontinence Impact at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356497|NCT01717456|Secondary|MHQ Incontinence Impact at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356498|NCT01717456|Secondary|Admission to Nursing Home at End of Treatment|Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.|End of Treatment (Week 6)|Analysis sample was all patients who provided data at end of treatment.|||participants|||Number
1356499|NCT01717456|Secondary|Urinary Incontinence Status Change From Baseline to End of Treatment|"OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:~0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)~- Patient is incontinent~- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)"|Baseline, end of treatment (week 6)|Analysis population consists of all patients who provided end of treatment data. Data were missing for 2/11 in Group A and 6/8 in Group B.|||units on a scale||Full Range|Median
1356500|NCT01717456|Secondary|Fecal Incontinence Frequency at End of Treatment|"OASIS question M1620: Bowel incontinence frequency. Response options are:~0 - Very rarely or never has bowel incontinence~- Less than once weekly~- One to three times weekly~- Four to six times weekly~- On a daily basis~- More often than once daily"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at the end of treatment visit. Data is missing for 2/11 in Group A and 6/8 in Group B.|||units on a scale||Full Range|Median
1356501|NCT01717456|Secondary|Zarit Caregiver Burden Scale at Follow Up|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.|6 months after (6-Week) treatment ends|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.|||units on a scale||Standard Deviation|Mean
1360904|NCT01669577|Primary|Death|30 days after trauma mortality evaluation|Within the first 30 days|severe polytrauma patients (ISS>15)|||participants|||Number
1356502|NCT01717456|Secondary|Zarit Caregiver Burden Scale at End of Treatment|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.|End of Treatment (Week 6)|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.|||units on a scale||Standard Deviation|Mean
1356503|NCT01717456|Secondary|MHQ Severity Scale at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356504|NCT01717456|Secondary|MHQ Severity Scale at End of Treatment|Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
1356505|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at Follow Up|"At follow up 6 months after the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder to treatment is a subject who answers yes. When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided."|6 months after (6-Week) treatment ends|Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.|||participants|||Number
1356506|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at End of Treatment|"At the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups."|End of Treatment (Week 6)|Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.|||participants|||Number
1356507|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)|At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.|6 months after (6-Week) treatment ends|The analysis sample consists of all patients who provided data at the 6 month FU visit.|||units on a scale||Standard Deviation|Mean
1356508|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at End of Treatment|At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.|End of Treatment (Week 6)|Analysis population includes all participants who provided end of treatment data to research assistants during a home visit. One subject from the EMB treatment did not provide data, and 1 subject from the SC group did not provide these data.|||units on a scale||Standard Deviation|Mean
1356509|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.|Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
1356510|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)|Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
1356511|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.|Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
1356512|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts|White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
1356513|NCT01717391|Secondary|Chemotherapy Compliance|The number of participants who had chemotherapy withheld at least once for low blood counts.|At 24 months||||Participants|||Count of Participants
1356733|NCT01714817|Secondary|Median Percent Change From Baseline in UPCR Over Time|A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.|Day 729||2019-05-31|05/2019||||
1356514|NCT01717391|Primary|Percent Difference From Baseline IMRT Plan (%)|The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.|Baseline (pre-treatment)|All participants who received an FLT PET/CT during radiation simulation.|||Percent difference (%)||Standard Deviation|Mean
1356515|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after end of therapy (up to 42 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
1356516|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|4 weeks after end of therapy (up to 22 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
1356517|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.|||percentage of participants||95% Confidence Interval|Number
1356518|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
1356519|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
1356520|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.|||percentage of participants||95% Confidence Interval|Number
1356521|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
1358926|NCT01690988|Secondary|ICU and/or Hospital Length of Stay|Assessed from patients' medical charts|Postoperative period|Outcome measure data were not collected.||||||
1356522|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
1356523|NCT01717326|Secondary|Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)|FAS; all randomized participants who received ≥1 dose of study treatment.|||days||Standard Error|Mean
1356524|NCT01717326|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|APaT population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).|||percentage of participants||95% Confidence Interval|Number
1356525|NCT01717326|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).|||percentage of participants||95% Confidence Interval|Number
1356526|NCT01717326|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after end of therapy (up to 30 weeks)|The Per-Protocol (PP) population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
1356527|NCT01717313|Post-Hoc|Change From Baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).|||mg/dL||95% Confidence Interval|Least Squares Mean
1356528|NCT01717313|Post-Hoc|Change From Baseline in FPG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).|||mg/dL||95% Confidence Interval|Least Squares Mean
1356529|NCT01717313|Post-Hoc|Change From Baseline in A1C at Week 24 (Phase A, Per-Protocol Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).|||Percent||95% Confidence Interval|Least Squares Mean
1356530|NCT01717313|Secondary|Change From Baseline in FPG at Week 54 (Phase A + Phase B, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1356531|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 54.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
1356532|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 54 (Phase A + Phase B, FAS Population)|"The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 54.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
1356533|NCT01717313|Secondary|Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
1356534|NCT01717313|Secondary|Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1356535|NCT01717313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1356536|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 24.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
1356546|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
1356734|NCT01714817|Secondary|Adjusted Mean Change From Baseline in UPCR Over Time|A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.|Day 729||2019-05-31|05/2019||||
1361869|NCT01661764|Other Pre-specified|C-reactive Protein||6 months||||mg/L||Standard Deviation|Mean
1356537|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 24.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
1356538|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1356539|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1356540|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 24 weeks|The APaT population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1356541|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 27 weeks|The All-Participants-as-Treated (APaT) population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1356542|NCT01717313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population)|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The Full Analysis Set (FAS) population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
1356543|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation|||Percentage of participants||95% Confidence Interval|Number
1356544|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <40 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation|||Percentage of participants||95% Confidence Interval|Number
1356545|NCT01717287|Secondary|Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had at least one postbaseline evaluation|||Percentage of participants||95% Confidence Interval|Number
1361325|NCT01665053|Secondary|Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
1356547|NCT01717287|Primary|Percentage of Participants With at Least One Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
1356548|NCT01717287|Secondary|Change From Baseline in CD4 Cell Percentage|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation|||Percentage change||95% Confidence Interval|Mean
1356549|NCT01717287|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation|||cells/mm^3||95% Confidence Interval|Mean
1356550|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
1356551|NCT01717287|Primary|Percentage of Participants With at Least One Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
1356552|NCT01717209|Secondary|Heart Rate|Heart Rate was measured as mean of Heart Rate for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for heart rate is generally 60 to 100 beats per minutes in adults, but this can vary.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||beats/minute||Full Range|Mean
1356553|NCT01717209|Secondary|Mean Arterial Pressure (MAP)|Mean Arterial Pressure (MAP) was measured as mean of MAP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for MAP is 70-110 mmHg.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||mmHg||Full Range|Mean
1356554|NCT01717209|Secondary|Central Venous Pressure (CVP)|Central Venous Pressure (CVP) was measured as mean of CVP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for CVP is 3-8 mmHg.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||mmHg||Full Range|Mean
1356555|NCT01717209|Secondary|Systemic Vascular Resistance (SVR)|Systemic Vascular Resistance (SVR) was measured as mean of Systemic Vascular Resistance (SVR) for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for SVR is 800-1200 dynes/sec/cm5.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||dynes/sec/cm^5||Full Range|Mean
1356556|NCT01717209|Secondary|Right Heart Dysfunction|Right Heart Dysfunction was measured as mean of Right Ventricular Stroke Work Index (RVSWI) for the initial 8 hours after admission to the Intensive Care Unit (ICU). RVSWI is measured as the difference in mean pulmonary artery pressure (MPAP) and central venous pressure (CVP), divided by the cardiac index (CI): [(MPAP-CVP) / CI]. Normal range for RVSWI is 5-10 g/m.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||g/m||Full Range|Mean
1356557|NCT01717209|Primary|Pulmonary Hypertension|Pulmonary hypertension was measured as mean of Mean Pulmonary Artery Pressure for initial 8 hours after admission to the Intensive Care Unit (ICU). MPAP value ≥25 mmHg (resting) indicates pulmonary hypertension state.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||mmHg||Full Range|Mean
1356558|NCT01717040|Primary|Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms|Baseline and Week 8||||units on a scale||Standard Error|Least Squares Mean
1356559|NCT01717014|Secondary|Usability: Manueverability|Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate|Operatively||||% of cases surgeon agree/strongly agree|||Number
1356560|NCT01717014|Secondary|Usability: Access|Access measured by surgeon usability questionnaire|Operatively||||% of cases surgeon agree/strongly agree|||Number
1356561|NCT01717014|Secondary|Usability: Visibility|Visibility measured by surgeon usability questionnaire.|Operatively||||% of cases surgeon agree/strongly agree|||Number
1356562|NCT01717014|Primary|Distal Margins|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative||||participants|||Number
1356563|NCT01717014|Primary|Staple Line|The surgeons ability to achieve a staple line at the desired level of the rectum.|Operative||||participants|||Number
1356703|NCT01715129|Secondary|Clinically Apparent Tumor Progression|Tumour progression was recorded according to the Investigator’s clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).|Day 92 and 183|ITT population|||participants|||Number
1356564|NCT01716754|Secondary|Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication|Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.|Baseline, Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had both baseline and week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.|||Number of puffs||Standard Error|Least Squares Mean
1356565|NCT01716754|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.|Baseline, Week 16, Week 28|The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.|||Score on a scale||Standard Deviation|Mean
1356566|NCT01716754|Secondary|Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 – > 95%; 1 – 90-95%; 2 – 80-89%; 3 – 70-79%; 4 – 60-69%; 5 – 50-59%; 6 – < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.|Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1356567|NCT01716754|Secondary|Change From Baseline in ACQ-7 Score|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 – > 95%; 1 – 90-95%; 2 – 80-89%; 3 – 70-79%; 4 – 60-69%; 5 – 50-59%; 6 – < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16 and 28|The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.|||Score on a scale||Standard Deviation|Mean
1356568|NCT01716754|Primary|Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 – > 95%; 1 – 90-95%; 2 – 80-89%; 3 – 70-79%; 4 – 60-69%; 5 – 50-59%; 6 – < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.|Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1356569|NCT01716663|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time RF is delivered during the procedure.|Day 0|Patients with non-missing RF application time.|||minutes||Standard Deviation|Mean
1356570|NCT01716663|Secondary|Mean Number of Radiofrequency (RF) Applications|RF application is defined as the number of times RF energy is delivered during the procedure.|Day 0|Patients with non-missing RF application values|||number of applications||Standard Deviation|Mean
1356571|NCT01716663|Secondary|Acute Procedural Success|Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.|Day 0|Acute effectiveness and efficiency cohort|||participants|||Number
1356572|NCT01716663|Secondary|Total Procedure Time|The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|The number of patients with non-missing procedure time data.|||minutes||Standard Deviation|Mean
1356573|NCT01716663|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|Those patients with non-missing fluoroscopy time.|||minutes||Standard Deviation|Mean
1356704|NCT01715129|Secondary|Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)|"0-4 ng/mL (normal PSA value)~>4 ng/mL (abnormal PSA levels)"|At Day 183|Subjects completed Day 183 visit (End of Study)|||Percentage of subjects|||Number
1356574|NCT01716585|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
1356575|NCT01716585|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
1356576|NCT01716585|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
1356577|NCT01716585|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
1356578|NCT01716585|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.|||percentage of participants|||Number
1356579|NCT01716585|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
1356580|NCT01716559|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 16|The analysis was performed on total population.|||participants|||Number
1356581|NCT01716559|Secondary|Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy|"Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as 1 denotes an effect on the response of treatment with or without iron replacement therapy. Response value as 0 denotes no effect on the response of treatment with or without iron replacement therapy."|Up to Week 16|The analysis was performed on total population. At the end of the study, data allowing the evaluation of effect of individual iron supplementation on the efficacy of Epoetin beta treatment were available for 103 participants out of total population of 160.|||participants|||Number
1356582|NCT01716559|Secondary|Percentage of Red Blood Cell Transfusion-free Participants|Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.|Up to Week 16|The analysis was performed on Total population.|||percentage of participants||95% Confidence Interval|Number
1356583|NCT01716559|Secondary|Mean Change From Baseline in Hemoglobin Level up to Week 16|The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.|Baseline, Week 4, Week 8, Week 12, and Week 16|"The analysis was performed on Total population. The n signifies the number of participants assessed for mean change in hemoglobin level for specified time point."|||g/dL||Standard Error|Mean
1356766|NCT01714336|Secondary|Number of Participants With Venous Thromboembolism (VTE) Diagnosis|Incidence of symptomatic VTE diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
1356767|NCT01714336|Secondary|Calculated Blood Loss|Calculated blood loss|5 days||||cc||Standard Deviation|Mean
1356768|NCT01714336|Secondary|Mean Number of Units Transfused|Mean number of units transfused per patient|5 days||||units/participant transfused||Standard Deviation|Mean
1356584|NCT01716559|Primary|Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8|Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.|Baseline to Week 8|The analysis was performed on total population. At the end of the Week 8, data allowing the evaluation of the therapeutic response was available for 103 participants out of total population of 160.|||percentage of participants||95% Confidence Interval|Number
1356585|NCT01716520|Secondary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 84)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
1356586|NCT01716520|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 83)|ITT Population. Only those participants available at the specified time point were analyzed.|||participants|||Number
1356587|NCT01716520|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.’s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)|ITT Population|||participants|||Number
1356588|NCT01716520|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.|Baseline and Day 14 of each treatment period (up to study day 83)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
1356589|NCT01716468|Primary|To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.|Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.|16 weeks|Solid cancers or blood cancers with measurable components in advanced or metastatic stages.|||participants|||Number
1356590|NCT01716455|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.|||ng/ml||Standard Deviation|Mean
1356591|NCT01716455|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.|||ng*hr/ml||Standard Deviation|Mean
1356592|NCT01716234|Secondary|Number of Participants With an Adverse Event Leading to Study Drug Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 28|The population analyzed was all treated participants.|||Participants|||Number
1356593|NCT01716234|Secondary|Number of Participants With an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 58|The population analyzed was all treated participants.|||Participants|||Number
1356594|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.|Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.|||ng/mL||Standard Deviation|Mean
1356595|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.|Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.|||ng/mL||Standard Deviation|Mean
1356596|NCT01716221|Other Pre-specified|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)||||units on a scale|||Number
1356597|NCT01716221|Secondary|Comparison of FARS and ICARS|Differences between FARS - ICARS at each treatment interval|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)||||points|||Number
1356598|NCT01716221|Primary|Friedreich Ataxia Rating Scale (FARS)|A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)||||points|||Number
1356599|NCT01716221|Primary|International Cooperative Ataxia Rating Scale (ICARS)|The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)||||units|||Number
1356600|NCT01716169|Primary|Percentage of Wound Surface Area Change From Baseline to Week 8|Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.|Baseline and Week 8||||percentage of wound surface area||95% Confidence Interval|Mean
1356601|NCT01716156|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy.|Up to Week 48|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1356602|NCT01716156|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy.|Up to Week 28|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1356622|NCT01715896|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||centimeter (cm)||Standard Error|Mean
1356603|NCT01716156|Secondary|Percentage of Participants With HCV RNA <25 IU/mL by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1356604|NCT01716156|Secondary|Percentage of Participants With Undetectable HCV RNA by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1356605|NCT01716156|Secondary|Time to Achievement of First Undetectable HCV RNA|The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|Up to Week 24|Full analysis set consists of all randomized participants receiving ≥1 dose of study therapy.|||Days||Standard Error|Mean
1356606|NCT01716156|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Up to 24 weeks|The APaT population included all randomized participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
1356607|NCT01716156|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Fourteen days following last dose of study drug (up to 26 weeks)|The All Participants as Treated (APaT) population included all randomized participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
1356608|NCT01716156|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|Up to Week 36|Per protocol population, as randomized. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1356609|NCT01716052|Primary|Measure of Discomfort of Mammography|The primary outcome measure will be the response to questions on a questionnaire.|3 years|No data was collected or analyzed for the outcome measure because the study was terminated.||||||
1356610|NCT01716013|Other Pre-specified|Wound Dehiscence Requiring Treatment|Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up|28 Days and 90 days|Intent-to-Treat (ITT) population|||percentage of participants|||Number
1356611|NCT01716013|Secondary|≥ 50% Wound Apposition at 10 Days|Incidence of wounds ≥50% apposed (10 ± 3 days)|10 days|Intent-to-treat (ITT) population|||percentage of participants|||Number
1356612|NCT01716013|Secondary|Optimal Cosmetic Outcome at 28 Days (Score of 6)|"Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.~One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:~Stepoff of borders (edges not on the same plane)~Contour irregularities (wrinkled skin near wound)~Margin separation (gap between sides)~Edge inversion (wound not properly everted)~Excessive distortion (swelling or edema or infection)~Poor overall appearance.~The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal."|28 days|Intent-to-treat (ITT) population|||percentage of participants|||Number
1356613|NCT01716013|Primary|100% Wound Apposition at 10 Days|Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.|10 days|Per protocol population (primary analysis dataset)|||percentage of participants|||Number
1356769|NCT01714336|Primary|Number of Participants Who Received a Hospitalization Transfusion|Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission|5 days||||participants|||Number
1356770|NCT01714323|Other Pre-specified|All-cause Mortality|Death from any cause in the 6 months after hospital discharge|6 months||||Participants|||Count of Participants
1356614|NCT01715948|Primary|Speech Spatial Qualities Questionnaire (SSQ)|"The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined."|Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.||||units on a scale||95% Confidence Interval|Mean
1356615|NCT01715948|Primary|Percentage of Words Recognized|Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.|Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..|The researchers chose not to include a condition with words presented at 90 degrees to the better ear in quiet.|||Percentage of words perceived correctly||95% Confidence Interval|Mean
1356616|NCT01715948|Primary|Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise|One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.|The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).||||words||95% Confidence Interval|Mean
1356617|NCT01715896|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.|||participants|||Number
1356618|NCT01715896|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after subcutaneous dose of mavrilimumab were calculated|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each this arm respectively."|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1356619|NCT01715896|Secondary|Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure. n'' signifies participants evaluable for specified category for each arm, respectively."|||millimeter per hour (mm/h)||Standard Deviation|Geometric Mean
1356620|NCT01715896|Secondary|Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline|The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
1356621|NCT01715896|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1356623|NCT01715896|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||mm||Standard Error|Mean
1356624|NCT01715896|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||millimeter (mm)||Standard Error|Mean
1356625|NCT01715896|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||joint count||Standard Error|Mean
1356626|NCT01715896|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356627|NCT01715896|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356628|NCT01715896|Secondary|Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356629|NCT01715896|Secondary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169|The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356630|NCT01715896|Secondary|Duration of DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."|||days||Standard Error|Mean
1356631|NCT01715896|Secondary|Time to Onset DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."|||days||90% Confidence Interval|Median
1356632|NCT01715896|Secondary|Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||participants|||Number
1356653|NCT01715883|Primary|Safety of Sodium Nitrite Administration Measured by Methemoglobin Levels|The safety of Sodium Nitrite administration will be assessed by methemoglobin levels during and 150 minutes after the nitrite infusion in the transplant recipient.|150 minutes post infusion||||percentage of methemoglobin||Standard Deviation|Mean
1356771|NCT01714323|Other Pre-specified|All-cause Hospitalizations|Self-reported admission to a hospital in the 12 months after the index hospitalization.|12 months||||hospital admissions|||Number
1356633|NCT01715896|Secondary|Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||participants|||Number
1356634|NCT01715896|Secondary|American College of Rheumatology (ACR) Hybrid Score at Day 169|ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||units on a scale||Full Range|Median
1356635|NCT01715896|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1356636|NCT01715896|Secondary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively"|||units on a scale||Standard Deviation|Mean
1356637|NCT01715896|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale was a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.|Day 169|"The safety population included all participants who received any amount of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1356638|NCT01715896|Secondary|Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (>) 20% reduction (RD) and absolute value (AV) less than (<) 80% predicted (PR).|Day 85 and 169|"The safety population included all participants who received any amount of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."|||participants|||Number
1356639|NCT01715896|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.|||participants|||Number
1356640|NCT01715896|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.|Baseline up to Day 169|The safety population included all participants who received any amount of investigational product.|||participants|||Number
1356641|NCT01715896|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.|||participants|||Number
1356642|NCT01715896|Primary|Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169|The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356643|NCT01715896|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356644|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|The ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356645|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|The ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356646|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|The ACR20 was defined as greater than or equal to (>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1356647|NCT01715883|Secondary|Number of ICU Free Days (IFD)|Defined as the number of days outside the ICU through Day 30 post transplantation.|Day 30 post transplantation.||||days||Standard Deviation|Mean
1356648|NCT01715883|Secondary|Number of Ventilator Free Days (VFD)|Defined as the number of days off mechanical ventilation at baseline through Day 30 post transplantation.|Baseline through Day 30 post transplantation.||||days||Standard Deviation|Mean
1356649|NCT01715883|Secondary|Number of Participants With Chronic Rejection|To evaluate the efficacy of Sodium Nitrite infusion into the procured lungs and the lung transplant recipient in the prevention of delayed allograft complications including the incidence of chronic rejection. Prevention of delayed allograft complications include clinically indicated spirometric and lung volume assessments of lung function performed as an indicator of Bronchiolitis Obliterans Syndrome (BOS), and evidence of pathological rejection by surveillance transbronchial lung biopsies.|Up to 12 months post lung transplant||||Participants|||Count of Participants
1356650|NCT01715883|Secondary|Number of Participants With Acute Rejection|To evaluate the efficacy of Sodium Nitrite infusion into the procured lungs and the lung transplant recipient in the prevention of delayed allograft complications including the incidence of acute rejection. Prevention of delayed allograft complications include clinically indicated spirometric and lung volume assessments of lung function performed as an indicator of Bronchiolitis Obliterans Syndrome (BOS), and evidence of pathological rejection by surveillance transbronchial lung biopsies.|Up to 12 months post lung transplant||||Participants|||Count of Participants
1356651|NCT01715883|Secondary|Number of Participants With Primary Graft Dysfunction Grades 2+3|The primary study endpoint is the incidence of grades 2+3 Primary Graft Dysfunction (PGD) based upon the worst PGD grade during the first 72 hours post organ reperfusion. The severity of PGD is graded 0-3 based on the presence or absence of diffuse opacities on chest radiograph and the ratio of arterial oxygen pressure to inspired oxygen concentration. The grading system predicts post-lung transplant outcomes with Grade 3 being the worst.|First 72 hours post organ reperfusion.||||Participants|||Count of Participants
1356652|NCT01715883|Primary|Safety of Sodium Nitrite Administration - Number of Participants With Fall in Patient's Mean Arterial Pressure Greater Than 20%|The safety of Sodium Nitrite administration will be assessed by the incidence of fall in patient's Mean Arterial Pressure greater than 20% from recorded baseline requiring discontinuation of drug infusion during and after the nitrite infusion in the transplant recipient. Mean Arterial Pressure will be monitored at 1 minute intervals during study drug infusion followed by 15 minute intervals for 1 hour.|Baseline and 1 hour post infusion||||Participants|||Count of Participants
1370772|NCT01560260|Secondary|Clinical Benefit Rate Defined as SD >= 9 Months, PR or CR||Up to 2 years|||||||
1356654|NCT01715857|Secondary|Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus|Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 – 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.|||percentage of timepoints|Participants||Number
1356655|NCT01715857|Secondary|Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus|Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.|||percentage of timepoints|Participants||Number
1356656|NCT01715857|Secondary|Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)|Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.|Anesthetic duration between 1 to 5 hours|All participants who received study drug and with available data.|||Yuan renminbi [RMB]/hour||Standard Deviation|Mean
1356657|NCT01715857|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.|From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes|All participants who received study drug and with available data.|||minutes||Standard Deviation|Mean
1356658|NCT01715857|Secondary|Time to Eye Opening|After cessation of anesthesia, the investigators lightly tapped on the participant’s forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.|From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes|All participants who received study drug and with available data.|||minutes||Standard Deviation|Mean
1356659|NCT01715857|Primary|Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).|24 hours after end of surgery|All participants who received study drug and with available data.|||scores on a scale||Standard Deviation|Mean
1356660|NCT01715857|Primary|Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.|End of surgery||||scores on a scale||Standard Deviation|Mean
1356661|NCT01715831|Secondary|ESR Level|ESR is an acute phase reactant and is a measure of inflammation.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm/hr||Standard Deviation|Mean
1356662|NCT01715831|Secondary|C-Reactive Protein (CRP) Level|CRP is an acute phase reactant and is a measure of inflammation.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1356663|NCT01715831|Secondary|Health Assessment Questionnaire (HAQ) Pain VAS Score|The HAQ pain VAS is a measure of pain on a continuous 100 mm scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 mm (severe pain).|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
1356664|NCT01715831|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/personal care, ability to stand-up, eating, walking, hygiene, reaching, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents ‘no disability’ and 3 represents ‘very severe, high-dependency disability’.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1356665|NCT01715831|Secondary|Participant's Pain Assessment Using VAS Score|"Participant’s pain assessment was made on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as no pain and 100 mm (right end of the line) as unbearable pain. The participant marked the line according to their assessment and the distance from the left edge was measured."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
1356666|NCT01715831|Secondary|Global Evaluation of Disease Activity by the Physician Using VAS Score|Physician global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as “inactive disease” (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as “disease maximum activity” (maximum activity of arthritis). The physician marked the line according to their assessment and the distance from the left edge was measured.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
1356700|NCT01715129|Secondary|Peak Plasma Concentration Value (Cmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.|||ng/mL||Standard Deviation|Mean
1356667|NCT01715831|Secondary|Global Evaluation of Disease Activity by the Participant Using VAS Score|Participant’s global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as “inactive disease” (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as “disease maximum activity” (maximum activity of arthritis). The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
1356668|NCT01715831|Secondary|Swollen Joint Count (SJC)|An assessment of 28 joints was conducted for swelling. Joints were assessed and classified as swollen/not swollen by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for swelling.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||swollen joints||Standard Deviation|Mean
1356669|NCT01715831|Secondary|Tender Joint Count (TJC)|An assessment of 28 joints was conducted for tenderness. Joints were assessed and classified as tender/not tender by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for tenderness.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||tender joints||Standard Deviation|Mean
1356670|NCT01715831|Secondary|Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), participant's global assessment of disease activity (general health [GH]) using visual analog scale (VAS), 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28 = [0.56 multiplied by (*) square root (√) of TJC28] plus (+) [0.28*√SJC28]+[0.70*the natural logarithm (ln) ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and follow-up (FU) Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1356671|NCT01715831|Primary|Number of Participants With AEs of Special Interest|Adverse events of special interest included following events: Infections (including opportunistic infections); myocardial infarction / acute coronary syndrome; gastrointestinal (GI) perforations and related events; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; hemorrhagic events; and hepatic events. Overall number of participants who experienced any of these AEs of special interest was reported.|From Baseline up to approximately 2 years|ITT population|||participants|||Number
1356672|NCT01715831|Primary|Number of Participants With AEs Leading to Dose Modification or Study Discontinuation||From Baseline up to approximately 2 years|ITT population|||participants|||Number
1356673|NCT01715831|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; significant medical event, according to the investigator discretion (e.g., may represent a risk to the participant or may require medical/surgical intervention to prevent one of the outcomes mentioned above).|From Baseline up to approximately 2 years|ITT population|||participants|||Number
1356674|NCT01715415|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
1356675|NCT01715415|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
1356676|NCT01715415|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.|||percentage of participants|||Number
1356701|NCT01715129|Secondary|Time to Cmax (Tmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|Pharmacokinetic (PK) profile was assessed in a subset of 18 subjects.|||Hours||Full Range|Median
1356702|NCT01715129|Secondary|Percentage of Subjects With Adverse Events||Up to Day 183|All subjects who received at least one dose of study treatment were included in safety population.|||Percentage of subjects|||Number
1356677|NCT01715415|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.|||percentage of participants|||Number
1356678|NCT01715415|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.|||percentage of participants|||Number
1356679|NCT01715415|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
1356680|NCT01715298|Secondary|Change From Baseline in Morning and Nighttime Symptom Scores|Patients are reporting morning and nighttime symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Morning and nighttime symptoms scores for each patient over 12 weeks are reported and analyzed. Symptom scores are calculated as the mean of the symptom scores (morning symptom scores or nighttime symptom scores, respectively) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The outcome is calculated as the change from baseline in the morning and nighttime symptom scores, respectively. A negative number indicates a reduction in the symptom severity and is owed to the calculation of the change from baseline.|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Score||Standard Error|Least Squares Mean
1356681|NCT01715298|Secondary|Change From Baseline in Mean Trough Forced Vital Capacity|Mean trough Forced Vital Capacity (FVC) is assessed as the arithmetic mean of two FVC measurements, conducted within the last hour of a 24 hours period from a morning dose, either that of day 1 or at week 12 of treatment (23:15 h and 23:45 h assessments). The endpoints are the change from baseline in trough FVC on Day 1 and at Week 12, with the mean of the -45 min and -15 min measurements on Day 1 as the baseline.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Liters||Standard Error|Least Squares Mean
1356682|NCT01715298|Secondary|Change From Baseline in Forced Vital Capacity at All Individual Timepoints|The Forced Vital Capacity (FVC)assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Serial lung function measurements are taken at the following time points following dosing on Day 1 and at week 12: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. For week 12 (day 85), the pre-dose measurements (-45 min and -15 min) and the trough measurements (23:15 h and 23:45 h post-dose) are included. The endpoints are the change from baseline in FVC following the morning dose on Day 1 and at Week 12. Where the FVC at any one timepoint is smaller than at baseline, a negative value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Liters||Standard Error|Least Squares Mean
1356683|NCT01715298|Secondary|"Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the evening questionnaire relates to the impact of COPD symptoms on the performance of usual daily activities (“Did your respiratory symptoms stop you performing your usual daily activities today“). The answer with the lowest symptom score is “not at all.” A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The change from baseline in the percentage of “days able to perform usual daily activities” is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline beingThe baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Percentage of days||Standard Error|Least Squares Mean
1356684|NCT01715298|Secondary|"Change From Baseline in the Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours in the evening questionnaire. The change from baseline in the percentage of days with “no daytime symptoms” is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline being. The baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Percentage of days||Standard Error|Least Squares Mean
1356685|NCT01715298|Secondary|"Change From Baseline in the Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the morning questionnaire relates to the number of awakenings due to COPD symptoms during the previous night. The answer with the lowest symptom score is “no waking due to symptoms.” A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. The change from baseline in the percentage of nights with “no nighttime awakening” is calculated from the mean percentage of nights with this answer over the 12 week treatment period, with the baseline being The baseline is calculated from the run-in epoch prior to randomization."|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Percentage of nights||Standard Error|Least Squares Mean
1356686|NCT01715298|Secondary|Change From Baseline in Daily Symptom Scores|Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Symptom scores are calculated as the mean of the combined daily symptom scores (combined from morning and evening scores) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The change from baseline in the least squares mean daily symptom scores over the 12 week treatment period is provided. Where the mean daily symptom score over the 12 week treatment period is lower than the baseline, the result is negative. A negative result indicates an improvement in COPD symptom severity.|day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||Score||Standard Error|Least Squares Mean
1356687|NCT01715298|Secondary|Change From Baseline in the Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated as the percentage of days without usage of rescue medication from during the the run-in epoch prior to randomization.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||percentage of days||Standard Error|Least Squares Mean
1356688|NCT01715298|Secondary|Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the mean daily number of puffs used per patient over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization (mean number of puffs per day). A negative number indicates a reduction in the mean daily number of puffs of rescue medication.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||Number of puffs||Standard Error|Least Squares Mean
1356689|NCT01715298|Secondary|Breathlessness Assessed by Transition Dyspnea Index|Breathlessness at week 12 is measured using the interviewer-administered Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the interviewer-administered Baseline Dyspnea Index (BDI). The change from BDI to TDI is assessed, with the TDI total score ranging from -9 to +9 units of the scale. The lower the score, the more deterioration in severity of dyspnea. Patients are considered to have clinically significant improvement (MCID) with the TDI score change versus BDI being equal to or greater than 1.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||Score||Standard Error|Least Squares Mean
1356690|NCT01715298|Secondary|Change From Baseline in the Health Status Assessed by St. George’s Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||Score||Standard Error|Least Squares Mean
1356691|NCT01715298|Secondary|Mean Trough Forced Expiratory Volume in One Second|Mean trough Forced Expiratory Volume in one second (FEV1) is assessed as the arithmetic mean of two FEV1 measurements, conducted within the last hour of a 24 hour period from a morning dose, either that of day 1 or at week 12 of treatment. The data is reported as the change from baseline (CFB), with the baseline being the arithmetic mean of the two pre-dose measurements (-45 min and -15 min) preceding the serial lung function measurements on Day 1|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||Liters||Standard Error|Least Squares Mean
1356772|NCT01714323|Secondary|Use of Smoking Cessation Treatment After Hospital Discharge|Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).|1 month, 3 months, 6 months||||Participants|||Count of Participants
1356692|NCT01715298|Secondary|Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Time points of the serial lung function measurements are 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The table indicates the percent change from baseline (CFB) in FEV1 and standard deviation in brackets. Where the FEV1 is lower than at baseline, a negative percent value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||Percent||Standard Deviation|Mean
1356693|NCT01715298|Secondary|Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1FEV1) is assessed for different time spans (0-4 h, 4-8 h, 8-12 h) within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various the following time points post dosing on day 1 and at week 12 to calculate the FEV1 AUC for these different time spans: .5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 or week 12, respectively, (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1 and Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||Liters||Standard Error|Least Squares Mean
1356694|NCT01715298|Secondary|Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is assessed at day 1 of treatment. Serial lung function measurements are taken at the following various time points post dosing at day 1 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~.The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1|||Liters||Standard Error|Least Squares Mean
1356695|NCT01715298|Primary|Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean FEV1 change from baseline (CFB) over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur"|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||Liters||Standard Error|Least Squares Mean
1356696|NCT01715207|Secondary|Central Aortic PWV(Pulsed Wave Velocity)|Aortic PWV was measured according to the well-validated method using MRI 19. From the velocity-encoded MRIs, aortic contours were automatically detected and manually adjusted in each slice area throughout the cardiac cycle. The transit time between the flow curves of each region of the aorta was determined from the midpoint of the systolic up-slope on the flow versus time curve 26-28. The up-slopes were identified by drawing a line between the points of 40% and 60% maximum velocity on the waveform. The distance between each aortic level was measured on black blood images using a curved line along the center of the aorta. Based on these data, the regional PWV was calculated as the ratio of the distance between levels and the time differences between the arrival of the pulse wave at each level. The PWV was measured at two regions: the proximal aorta (proximal PWV between level 1 and level 2) and the entire aorta (PWV-total between level 1 and level 4).|6 months|MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.|||m/s||Standard Deviation|Mean
1356697|NCT01715207|Primary|Central Aortic Distensibility by MRI|Analyses of the MRIs were performed using commercial software (Argus version 4.02, Siemens Medical Systems, Germany) by experienced observers who were blinded to patient information. To measure central aortic distensibility, the systolic and diastolic cross-sectional areas were measured by manual contouring of the aorta through the cardiac cycle on the cine image. Distensibility at the four regions was calculated as the mean of values obtained from the following equation: Distensibility = (Amax - Amin)/[Amin × (Pmax - Pmin)](10-3mm/Hg), where Amax is the maximal (systolic) aortic area, Amin is the minimal (diastolic) aortic area, Pmax is the systolic blood pressure (SBP), and Pmin is the diastolic blood pressure (DBP). Central aortic blood pressure measured non-invasively by SphygmoCor was used for systolic and diastolic blood pressure.|6 months|MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.|||(mmHg ^ -1) x 10 ^ -3||Standard Deviation|Mean
1356698|NCT01715129|Secondary|Cmin of Triptorelin in Subset of 18 Subjects||At Day 92 and 183|Day 92: Four subjects (presenting particularly high levels of triptorelin) were excluded from 18-subject subset.|||ng/mL||Standard Deviation|Mean
1356699|NCT01715129|Secondary|Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.|||h*ng/mL||Standard Deviation|Mean
1361326|NCT01665053|Secondary|Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
1356705|NCT01715129|Secondary|Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects|Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.|From Day 1 (Baseline) to Day 183 (End of study)|ITT population at End of Study (Day 183). One subject had no data.|||Percentage Change||Standard Deviation|Mean
1356706|NCT01715129|Secondary|Plasma Triptorelin Levels (Cmin)|Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.|At Day 92 and 183|ITT population. No samples were collected from 4 subjects at Day 92 and 9 subjects at Day 183|||ng/mL||Standard Deviation|Mean
1356707|NCT01715129|Secondary|Time to Achieve Castration (Tcast)|Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)|Up to Day 36|ITT population|||Day||95% Confidence Interval|Median
1356708|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95|Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|Day 95|IC1 population.|||Percentage of subjects||95% Confidence Interval|Number
1356709|NCT01715129|Secondary|Probability of Testosterone <50 ng/dL|"Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.~LC-MS/MS: Liquid Chromatography–Tandem Mass Spectrometry"|Day 29 through Day 183|Intention-to-treat (ITT) population: All treated subjects|||Proportion of subjects||95% Confidence Interval|Number
1356710|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose|Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|At Day 92|Initially Castrated (IC1) population: All treated subjects with testosterone levels <50 ng/dL at Day 29 or at Day 36, assessed with the LC-MS/MS method and missing data imputed by immunoassay method.|||Percentage of subjects||95% Confidence Interval|Number
1356711|NCT01715129|Primary|Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183|Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183|At Day 29 and 183|N=Number of subjects attending the visit|||Percentage of subjects||95% Confidence Interval|Number
1356712|NCT01715064|Secondary|Exercise-Induced Feelings Inventory - Questionnaire (EIFI)|Correlations will be assessed between cortical silent period and exercise-induced feelings.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
1356713|NCT01715064|Secondary|Hospital Anxiety and Depression Scale - Questionnaire(HADS)|Correlations will be assessed between cortical silent period and acute anxiety and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
1356714|NCT01715064|Secondary|State-Trait Anxiety Inventory - Questionnaire(STAI)|Correlations will be assessed between cortical silent period and acute anxiety.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
1356715|NCT01715064|Secondary|Profile of Mood States Questionnaire(PoMS)|Correlations will be assessed between cortical silent period and acute mood state.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
1356716|NCT01715064|Primary|Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.|CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||seconds||Standard Deviation|Mean
1356717|NCT01714817|Secondary|Number of Participants With Other Marked Chemistry Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R|Day 729||2019-05-31|05/2019||||
1356732|NCT01714817|Secondary|Adjusted Mean Change From Baseline in eGFR Over Time|Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.|Day 729||2019-05-31|05/2019||||
1356718|NCT01714817|Secondary|Number of Participants With Marked Urinalysis Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4|Day 729||2019-05-31|05/2019||||
1356719|NCT01714817|Secondary|Number of Participants With Marked Electrolyte Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN|Day 729||2019-05-31|05/2019||||
1356720|NCT01714817|Secondary|Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX|Day 729||2019-05-31|05/2019||||
1356721|NCT01714817|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL|Day 729||2019-05-31|05/2019||||
1356722|NCT01714817|Secondary|Mean Change From Baseline in Laboratory Analytes During the Double-blind Period|Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.|Day 1 to Day 729||2019-05-31|05/2019||||
1356723|NCT01714817|Secondary|Summary Statistics for Heart Rate|Summary statistics for Heart Rate|Day 1 to Day 729||2019-05-31|05/2019||||
1356724|NCT01714817|Secondary|Summary Statistics for Diastolic Blood Pressure|Summary statistics for diastolic blood pressure|Day 1 to Day 729||2019-05-31|05/2019||||
1356725|NCT01714817|Secondary|Summary Statistics for Systolic Blood Pressure|Summary statistics for systolic blood pressure|Day 1 to Day 729||2019-05-31|05/2019||||
1356726|NCT01714817|Secondary|AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval|AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.|Days 337 to 365|As per the study protocol, this Outcome Measure was only planned to be analyzed upon the successful completion of the Primary Endpoint. Since the study failed to meet the primary endpoint, this Outcome was not analyzed.||||||
1356727|NCT01714817|Secondary|Cmax: Maximum Observed Serum Concentration Following Subjects Receiving Active Abatacept IV|Cmax: Maximum observed serum concentration following subjects receiving active abatacept IV|at 1 hour post Day 1 dose and 30 minutes post Day 337 dose|As per the study protocol, this Outcome Measure was only planned to be analyzed upon the successful completion of the Primary Endpoint. Since the study failed to meet the primary endpoint, this Outcome was not analyzed||||||
1356728|NCT01714817|Secondary|Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion|Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365|Days 1 to 365|As per the study protocol, this Outcome Measure was only planned to be analyzed upon the successful completion of the Primary Endpoint. Since the study failed to meet the primary endpoint, this Outcome was not analyzed.||||||
1356729|NCT01714817|Secondary|Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period|BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG “A” represents the presence of one or more serious features of lupus. A BILAG “B” represents more moderate features of the disease. A BILAG “C” includes only mild symptomatic features. A BILAG “D” represents only prior activity with no current symptoms due to active lupus. A BILAG “E” represents an organ that has never been involved.|Day 1 to Day 729||2019-05-31|05/2019||||
1356730|NCT01714817|Secondary|Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period|Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.|Day 729||2019-05-31|05/2019||||
1356731|NCT01714817|Secondary|Time to First Sustained Change to No Response During the Double-blind Period|Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn|Day 729||2019-05-31|05/2019||||
1361999|NCT01660672|Primary|Freedom From Seizure|Number of subjects free of seizure at 24 hours after initiation of treatment|24 hours||||individuals|||Number
1356735|NCT01714817|Secondary|Median Time to Partial Response (PR) During the Double-blind Period in Nephrotic Participants|The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Subject does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment|Day 729||2019-05-31|05/2019||||
1356736|NCT01714817|Secondary|Median Time to Partial Response (PR) During the Double-blind Period in All Participants|The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Subject does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment|Day 729||2019-05-31|05/2019||||
1356737|NCT01714817|Secondary|Median Time to Complete Response (CR) During the Double-blind Period in Nephrotic Participants|The estimate of median time to Complete Response (CR) in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.|Day 729||2019-05-31|05/2019||||
1356738|NCT01714817|Secondary|Median Time to Complete Response (CR) During the Double-blind Period in All Participants|The estimate of median time to Complete Response (CR) is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.|Day 729||2019-05-31|05/2019||||
1356739|NCT01714817|Secondary|Number of Participants With Ranked Outcome of CR, PR, and No Response Throughout the Double-blind Period|Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial renal response (PR): defined as meeting ALL of the following criteria: Subject does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn|Day 729||2019-05-31|05/2019||||
1356740|NCT01714817|Secondary|Number of Participants With Any Adverse Events (AEs)|All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 19.1). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.|From Day 1 up to 56 days post last dose in Year 1 of the double-blind period|All treated participants|||Participants|||Number
1356741|NCT01714817|Secondary|Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period|Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG “A” represents the presence of serious features of lupus. BILAG “B” represents more moderate features of the disease. BILAG “C” includes only mild symptomatic features. BILAG “D” represents prior activity with no current symptoms due to active lupus. BILAG “E” represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.|Day 1 to Day 365|All randomized and treated participants|||BILAG score||95% Confidence Interval|Mean
1356742|NCT01714817|Secondary|Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population|Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population|Day 1 and Day 365|All Randomized and Treated Participants with both post-baseline and baseline measurements|||UPCR (mg/mg)||Standard Error|Mean
1356743|NCT01714817|Secondary|Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Nephrotic Participants|Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in nephrotic participants|Baseline and Day 365|All Randomized and Treated Nephrotic participants with both post-baseline and baseline measurements|||UPCR (mg/mg)||Standard Error|Mean
1356744|NCT01714817|Secondary|Percentage of Nephrotic Participants in CR of Lupus Glomerulonephritis at Day 365 of the Double-blind Period|Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. Nephrotic is defined as screening UPCR >=3.0 mg/mg (>=339mg/mmol). CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.|365 days|All randomized and treated nephrotic participants. Nephrotic is defined as screening UPCR >= 3.0mg/mg (>=339mg/mmol)|||Percentage|||Number
1356745|NCT01714817|Primary|Percentage of Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period|Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. Complete Response (CR) defined as: eGFR is normal or no <85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.|365 days|All randomized and treated participants|||Percentage|||Number
1356746|NCT01714804|Secondary|Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)||12 months|Data were not collected||||||
1356747|NCT01714804|Primary|Number of Levels With Posterolateral Fusion|Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately|12 months|One level is defined as a spinal segment in the lumbar spine.|||levels|levels||Count of Units
1356748|NCT01714635|Secondary|Spectacle Independence|Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.|six months|Five subjects (3 from Group #1 [145-142], 1 from Group #2 [150-149], and 1 from the monofocal control group [146-145]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.|||participants|||Number
1356749|NCT01714635|Secondary|Mean Diopter Range With VA of 20/40 or Better|"Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.~* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively."|six months|eyes|||diopters||Standard Deviation|Mean
1356750|NCT01714635|Primary|Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm|Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative|six months|eyes|||LogMAR VA||Standard Deviation|Mean
1356751|NCT01714609|Primary|Patients With Change in HVPG From Baseline|Number of participants with a decrease in HPVG that was > 10% of baseline|Three Months||||participants|||Number
1356752|NCT01714544|Primary|Investigator's Global Assessment (IGA)|The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).|28 days|Intent to treat population, with LOCF for missing data|||percentage of subjects||95% Confidence Interval|Number
1356753|NCT01714505|Primary|Safety, Frequency of Hypoglycemia|Hypoglycemic episodes are defined as BG < 3.9mmol/L|40 hours (x 2 admissions)||||hypoglycemic episodes/participant||Standard Deviation|Mean
1356754|NCT01714505|Secondary|Efficacy, Time Spent in Target Range|Percentage of time in the target range of 3.9–10 mmol/L (70–180 mg/dL).|40 hours (x2 admissions)||||percentage of time spent in range||Standard Deviation|Mean
1356755|NCT01714505|Primary|Safety, Low Blood Glucose Index (LBGI)|"The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in “risk space.” Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes.~LBGI < 2.5 is associated with low risk of hypoglycemia, 2.5 < LBGI < 5 is associated with a moderate risk of hypoglycemia and LBGI > 5 is associated with a high risk of hypoglycemia."|40 hours (x2 admissions)||||index score||Standard Deviation|Mean
1356756|NCT01714492|Secondary|Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative||||MPa|Participants|Standard Deviation|Mean
1356757|NCT01714492|Secondary|Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative||||mm^2|Participants|Standard Deviation|Mean
1356758|NCT01714492|Primary|Range of Motion During Flexion of Deep Knee Bend Activity||10 yrs post-operative||||degrees|Participants|Standard Deviation|Mean
1356759|NCT01714492|Primary|Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity||10 yrs post-operative||||degrees|Participants|Standard Deviation|Mean
1356760|NCT01714492|Secondary|In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity|"The intended unit of measure is times Body Weight (or xBW), relating to a ratio."|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation|||times body weight|Participants|Standard Deviation|Mean
1356761|NCT01714492|Primary|In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity|The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.|||mm|Participants|Standard Deviation|Mean
1356762|NCT01714336|Secondary|Number of Participants Who Died|All-cause mortality at 6 months|6 months after surgery||||participants|||Number
1356763|NCT01714336|Secondary|Number of Participants With Cerebrovascular Accident (CVA) Diagnosis|CVA diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
1356764|NCT01714336|Secondary|Number of Participants With Myocardial Infarction (MI) Diagnosis|MI diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
1356765|NCT01714336|Secondary|Number of Participants With Wound Complications|Wound complications diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
1356773|NCT01714323|Secondary|Duration of Tobacco Abstinence After Hospital Discharge|Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.|1 month, 3 months, 6 months||||days||Inter-Quartile Range|Median
1356774|NCT01714323|Secondary|Point Prevalence Tobacco Abstinence|7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report|1 month, 3 months, 6 months||||Participants|||Count of Participants
1356775|NCT01714323|Secondary|Continuous Tobacco Abstinence|Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.|1 month, 3 months, 6 months||||Participants|||Count of Participants
1356776|NCT01714323|Primary|Tobacco Abstinence - 6 Month Follow-up|Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up|6 months||||Participants|||Count of Participants
1356777|NCT01714310|Other Pre-specified|Affective Reactivity Index Child Report|Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.|Baseline through week 12.|||||||
1356778|NCT01714310|Other Pre-specified|Children's Depression Rating Scale|Clinician completed dimensional rating of depressive symptoms.|Baseline through week 12.|||||||
1356779|NCT01714310|Other Pre-specified|Pediatric Anxiety Rating Scale|Clinician completed dimensional assessment of anxiety symptoms.|Baseline through week 12.|||||||
1356780|NCT01714310|Secondary|Diastolic Blood Pressure|Diastolic Blood pressure measured in mmHG.|Baseline through week 12.|Some participants discontinued as trial progressed.|||mm Hg.||Standard Error|Least Squares Mean
1356781|NCT01714310|Secondary|Systolic Blood Pressure|Systolic Blood Pressure measured in mmHG|Baseline through week 12.|Some participants discontinued as trial progressed.|||mm Hg.||Standard Error|Least Squares Mean
1356782|NCT01714310|Secondary|Pulse|Heart rate in beats per minute.|Baseline through week 12.|Some participants discontinued as trial progressed.|||beats per minute.||Standard Error|Least Squares Mean
1356783|NCT01714310|Secondary|Weight|Weight in kg.|Baseline through week 12.|Some participants discontinued as trial progressed.|||kg.||Standard Error|Least Squares Mean
1356784|NCT01714310|Secondary|Height|A dimensional measure assessed in cms.|Baseline through week 12.|Participants discontinued as trial progressed.|||cm.||Standard Error|Least Squares Mean
1356785|NCT01714310|Secondary|Clinical Global Impression - Improvement|Percentage improved by treatment group|Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.|Some participants discontinued as trial progressed.|||Participants|||Count of Participants
1356786|NCT01714310|Secondary|Revised Modified Overt Aggression Scale - Total Score|A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.|Baseline through week 12.|Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356787|NCT01714310|Secondary|Affective Reactivity Index - Parent Report|A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.|Baseline through week 12.|Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356788|NCT01714310|Secondary|Conners Teacher Global Index|Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.|Baseline through week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356789|NCT01714310|Secondary|Conners Global Index Restless-Impulsive Subscale Parent Report|A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.|Baseline through week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356790|NCT01714310|Secondary|Conners Global Index Emotional Lability Subscale - Parent Report|A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.|Baseline to week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356791|NCT01714310|Secondary|Conners Parent Global Index|Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.|Baseline through week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356792|NCT01714310|Secondary|ADHD-IV Rating Scale|A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.|Baseline through week 12.|Participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356793|NCT01714310|Primary|Clinical Global Impression-Severity-Severe Mood Dysregulation|A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.|Baseline through week 12.|Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
1356804|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Percentage of Participants|||Number
1372759|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||1 week of age|||||||
1356794|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with Blood Glucose >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
1356795|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose (BG) <=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
1356796|NCT01714232|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed.|||Percent Difference||Standard Error|Mean
1356797|NCT01714024|Secondary|Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.|Findings from expression arrays will be used to perform quantitative PCR analyses using SAB Superarrays (SuperArray GEArray), to enable a quantitativeassay of mRNA levels of specific inflammatory and growth factor molecules|4 weeks||||Fold Change||Standard Deviation|Mean
1356798|NCT01714024|Primary|Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.|Samples were analyzed comparing the osteogenic potential associated with titanium and porous tantalum dental implants (cylinders) at 2 and 4 weeks using transcriptome analyses. The primary outcome data are displayed showing the Average Delta ∆ (Ct) for osteogenic genes relative to the housekeeping markers. The numerical value of the CT is inversely related to the amount of amplicon in the reaction (i.e., the lower the CT, the greater the amount of amplicon).|2 weeks & 4 weeks post placement||||Average Delta ∆ (Ct)||Standard Deviation|Mean
1356799|NCT01713998|Secondary|Subject Assessment of Improvement at 180 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|180 days post-treatment||||percentage of participants|||Number
1356800|NCT01713998|Secondary|Subject Assessment of Improvement at 90 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|90 days post-treatment||||percentage of participants|||Number
1356801|NCT01713998|Secondary|Quantitative Assessment of Brow Lift at 90 Days Post-treatment|Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.|90 days post-treatment||||Participants|||Number
1356802|NCT01713998|Primary|Overall Improvement in Skin Laxity on the Face and Neck|A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.|90 days post-treatment||||Participants|||Number
1356803|NCT01713998|Primary|Subjects' Assessment of Pain During Treatment With Lower Energy Settings|"Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.~Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed."|Participants were assessed for the duration of study treatment, an average of 75 minutes||||units on a scale||Full Range|Mean
1358116|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1356805|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 90 days post-treatment|wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||Percentage of Participants|||Number
1356806|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Percentage of Participants|||Number
1356807|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||Percentage of Participants|||Number
1356808|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 60 days post-treatment|Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Percentage of Participants|||Number
1356809|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Millimeters||Full Range|Mean
1356810|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||Millimeters||Full Range|Mean
1356811|NCT01713933|Secondary|Quantitative Improvement in Skin Laxity|Assess change in brachial volume based on brachial tissue measurements.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||percentage of participants improved|||Number
1356812|NCT01713933|Primary|Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity|Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||percentage of participants improved|||Number
1356813|NCT01713686|Secondary|Subject Satisfaction at 180 Days Post-treatment|"Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:~Very Satisfied~Satisfied~Neither Satisfied or Dissatisfied~Dissatisfied~Very Dissatisfied~Satisfied = Very Satisfied + Satisfied~Dissatisfied = Dissatisfied + Very Dissatisfied"|180 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit.|||percentage of participants|||Number
1356814|NCT01713686|Secondary|Subject Satisfaction at 90 Days Post-treatment|"Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:~Very Satisfied~Satisfied~Neither Satisfied or Dissatisfied~Dissatisfied~Very Dissatisfied~Satisfied= Very Satisfied + Satisfied~Dissatisfied=Dissatisfied + Very Dissatisfied"|90 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit.|||percentage of participants|||Number
1356815|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.~Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.~Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|180 days post treatment|The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.|||percentage of participants|||Number
1358117|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1356816|NCT01713686|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:~Very much improved~Much improved~Improved~No change~Worse~The scale was completed in two steps:~Based on a live assessment of the subject while referring to the subject’s pre-treatment photographs; and~Based on a comparison of the subject’s pre-treatment photographs to current post-treatment photographs.~Improved = Very Much Improved + Much Improved + Improved"|180 days post-treatment|Analysis population was based the number of subjects completing a 180 day follow-up visit.|||percentage of participants|||Number
1356817|NCT01713686|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:~Very much improved~Much improved~Improved~No change~Worse~The scale was completed in two steps:~Based on a live assessment of the subject while referring to the subject’s pre-treatment photographs; and~Based on a comparison of the subject’s pre-treatment photographs to current post-treatment photographs.~Improved = Very Much Improved + Much Improved + Improved"|90 days post-treatment|This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.|||percentage of participants|||Number
1356818|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.~Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.~Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|90 Days post-treatment|The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as ‘missing’ by the statistician and were not included in the denominator for the masked assessment analyses.|||percentage of participants|||Number
1356819|NCT01713660|Secondary|Percent of Seidel Staining|Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.|Day 0 (performed immediately post-incision creation), Day 1||||percentage of eyes with negative Seidel|Participants||Number
1356820|NCT01713660|Secondary|Surgeon Assessment of Workflow|Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?|Day 0, Operative||||percentage of yes answers|||Number
1356821|NCT01713660|Primary|Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.|Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).|Day 0, Operative (Within 2 hours of incision creation)||||mm|Participants|Standard Deviation|Mean
1356822|NCT01713621|Primary|Minimum Inhibitory Concentration (MIC) and Minimum Parasiticidal Concentration (MPC)|The estimated MIC and MPC were derived from the fitted parasitaemia concentration and PK/PD relationship.|up to 28 days|Model predicted MIC and MPC|||ng/Ml||Standard Deviation|Mean
1356823|NCT01713608|Secondary|OZ439 t½|OZ439 estimated terminal phase half life|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||hours||Standard Deviation|Mean
1356824|NCT01713608|Primary|OZ439 AUCτ|OZ439 Area under the plasma concentration vs time curve from time zero to the time of the last quantifiable concentration t calculated using a log-linear trapezoidal method|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||ng*h/mL||Standard Deviation|Mean
1356825|NCT01713608|Secondary|OZ439 Tmax|Time to reach maximum measured OZ439 plasma concentration|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||hours||Standard Deviation|Mean
1356826|NCT01713608|Primary|OZ439 Cmax|OZ439 maximum measured plasma concentration|Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||ng/mL||Standard Deviation|Mean
1356827|NCT01713530|Secondary|Incidence of Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||number of events|||Number
1356828|NCT01713530|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
1356888|NCT01712685|Secondary|Kinetic (Ki) Rate Constant|Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||1/Minutes||Standard Deviation|Mean
1378463|NCT01472874|Secondary|Zn Urine||Pre Treatment (mean)||||mcg/24hr||Standard Deviation|Mean
1356829|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:~Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia"|During Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
1356830|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))|During Weeks 0-26|The safety Analysis Set (SAS): included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
1356831|NCT01713530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects (2 subjects-baseline FPG not measured). The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.|||mmol/L||Standard Error|Least Squares Mean
1356832|NCT01713530|Primary|Change From Baseline in HbA1c (%)|Change from baseline in HbA1c (%) after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.|||percentage change in HbA1c||Standard Error|Least Squares Mean
1356833|NCT01713400|Secondary|Incidence of Acute Graft vs. Host Disease (AGVHD)|Cumulative incidence of Grade II – IV AGVHD to be characterized weekly from day of transplant to day 100 using the 1995 updated grading scheme for Graft vs. Host Disease (GVHD) developed by Glucksberg, et al.|100 days post transplant|All participating recipients|||percentage of participants|||Number
1356834|NCT01713400|Primary|T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio|"Median Blood Treg/Total CD4+ Ratio at day 30 following hematopoietic cell transplantation (HCT). Comparison between study arms: Ustekinumab vs. Placebo. From NCI Dictionary: T reg - A type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. T regs are being studied in the treatment of cancer. A T reg is a type of white blood cell and a type of lymphocyte. Also called regulatory T cell, suppressor T cell, and T-regulatory cell."|30 days post transplant|All participating recipients|||ratio||Full Range|Median
1356835|NCT01713348|Secondary|HbA1c||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle.|||Percent||Standard Deviation|Mean
1356836|NCT01713348|Secondary|HbA1c (mmol/Mol)||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.|||mmol/mol||Standard Deviation|Mean
1356837|NCT01713348|Secondary|Glucose Standard Deviation (SD)||Day 86 to 100 compared to day 1 to 15||||mmol/L||Standard Deviation|Mean
1356838|NCT01713348|Secondary|Time in Range|Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.|Days 86 to 100 intervention arm compared to control arm|All analyses were performed according to the intention-to-treat principle.|||hours per day||Standard Deviation|Mean
1356839|NCT01713348|Primary|Time in Range|Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.|Day 86 to 100 compared to Day 1 to 15|All analyses were performed according to the intention-to-treat principle.|||hours per day||Standard Deviation|Mean
1356840|NCT01713283|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1356841|NCT01713283|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1356842|NCT01713283|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1356843|NCT01713283|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
1356844|NCT01713283|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1356864|NCT01713036|Secondary|The Volume of Distribution of the Central or Plasma Compartment (Vc) of Intravenous [14C] Pimasertib|The volume of distribution of the central or plasma compartment (Vc) was calculated using the formula=Dose/C0|Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Liter||95% Confidence Interval|Geometric Mean
1358239|NCT01700348|Secondary|Number of Bleeding Sites|Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks|||||||
1356845|NCT01713036|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30+/-2 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|Part A and B: From the first dose of study drug administration until 30+/-2 days after the last dose of study drug administration, assessed up to 18 months|The safety analysis set included all subjects who received at least one administration of trial medication and have at least one subsequent safety assessment.|||subjects|||Number
1356846|NCT01713036|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)|Anti tumor activity defined as CR, PR, or stable disease and PD based on the investigator tumor evaluations performed every 2 cycles in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. CR =Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm); PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions; SD= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones.|From the screening every 2 cycles until end of the treatment, assessed up to 18 months|Safety analysis set included all subjects who received at least one administration of trial medication and had at least one subsequent safety assessment.|||subjects|||Number
1356847|NCT01713036|Secondary|Blood/ Plasma Concentration Ratios of Total [14C] Radioactivity||1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Ratio||Standard Deviation|Mean
1356848|NCT01713036|Secondary|Fraction Unbound of [14C] Pimasertib|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration multiplied by 100.|1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||percentage of unbound drug||Standard Deviation|Mean
1356849|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of M445 and M554||Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
1356850|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of M445 and M554|The λz of M445 and M554 was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||per hour||95% Confidence Interval|Geometric Mean
1356851|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M445 and M554|AUC from time 0 to infinity (AUC0-inf), was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/lambda z (λz). Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
1356852|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) of M445 and M554|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
1356853|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of M445 and M554|Time to reach maximum plasma concentration (Tmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
1356854|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of M445 and M554|Maximum observed plasma concentration (Cmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Nanogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
1357494|NCT01708057|Primary|Change From Baseline in Trough FEV1 (22-26h)|The average over 22 to 26 hours, as change from baseline|22 to 26 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.||||||
1356855|NCT01713036|Secondary|Apparent Volume of Distribution of Total [14C] Radioactivity During the Terminal Phase Following Oral Administration (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Vz/f of total radioactivity during the terminal phase was calculated by dividing the dose with the product of area under the plasma concentration time curve and apparent terminal rate constant (dose/AUC0inf*λz).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Liter||95% Confidence Interval|Geometric Mean
1356856|NCT01713036|Secondary|Total Body Clearance of Total [14C] Radioactivity From Plasma Following Oral Administration (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed. Apparent body clearance of total radioactivity from plasma was calculated by dividing the dose with area under the plasma concentration time curve from zero to infinity (Dose/AUC0inf).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||liter per hour||95% Confidence Interval|Geometric Mean
1356857|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
1356858|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Total [14C] Radioactivity|λz of total [14C] radioactivity was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||per hour||95% Confidence Interval|Geometric Mean
1356859|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Total [14C] Radioactivity|Area under the concentration time curve (AUC) from time zero to infinity (AUC0-inf) was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/λz. Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
1356860|NCT01713036|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total [14C] Radioactivity|Area under the plasma concentration time curve from time zero to the last sampling time at which the concentration is at or above the lower limit of quantification was calculated by using mixed log linear trapezoidal rule. Unit of assessment was hour*nanogram equivalent per milliliter (hr*ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
1356861|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
1356862|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity|Unit of assessment was nanogram equivalent per milliliter (ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||ng eq/mL||95% Confidence Interval|Geometric Mean
1356863|NCT01713036|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Oral Administration (Vz/f) and the Apparent Volume of Distribution During the Terminal Phase Following Intravenous Administration (Vz) of [14C] Pimasertib|The apparent volume of distribution during the terminal phase following oral administration (Vz/f) and the apparent volume of distribution during the terminal phase following intravenous administration was calculated by using the formula=Dose/( AUC0-inf* λz).|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Liter||95% Confidence Interval|Geometric Mean
1358240|NCT01700348|Secondary|Gingival Inflammation|Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.|4 weeks|||||||
1356865|NCT01713036|Secondary|Total Body Clearance of Unlabeled Pimasertib (CL/f) and Intravenous [14C] Pimasertib (CL)|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||liter per hour||95% Confidence Interval|Geometric Mean
1356866|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib|Apparent terminal elimination rate constant (λz) was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||per hour||95% Confidence Interval|Geometric Mean
1356867|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hours||Full Range|Median
1356868|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Intravenous [14C] Pimasertib||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||picogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
1356869|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Unlabeled Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||ng/mL||95% Confidence Interval|Geometric Mean
1356870|NCT01713036|Primary|Number of Metabolites Identified Overall and as Major|Identification and profiling of the metabolites was done. The total number of metabolites and the number of metabolites identified as major were reported.|Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||metabolites|||Number
1356871|NCT01713036|Primary|Plasma Concentrations of Pimasertib Metabolites|Plasma concentration of the Pimasertib metabolite M445 and M554 were presented for the outcome measure.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A. Here 'n' is the number of subjects analysed at each time point.|||Nanogram equivalent per milliliter||Standard Deviation|Mean
1356872|NCT01713036|Primary|Plasma Concentrations of [14C] Pimasertib||Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||nanogram equivalent per milliliter||Standard Deviation|Mean
1356873|NCT01713036|Primary|Mass Balance: Amount of Total Radioactivity Recovered Into the Urine and Feces From Time Zero to the Last Sampling Time Point (Ae0-t)|Recovery of total [14C]-radioactivity was determined in excreta, i.e., urine and feces at each sampling period subsequent to oral administration of [14C]-pimasertib on Day 8. Cumulative recovery of total [14C]-radioactivity in terms of percentage of dose recovered in urine and feces and total percentage of dose recovered was reported for the outcome measure.|Urine: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours post [14C]-labeled pimasertib dose on Day 8; Feces: 0-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||percentage of dose recovered||Full Range|Geometric Mean
1356874|NCT01713036|Primary|Oral Bioavailability of Pimasertib After Single Oral Dose of Unlabeled Pimasertib and Intravenous (IV) Single Tracer Dose of [14C] Pimasertib|Oral bioavailability (F) was calculated using the formula=AUC0-inf oral/dose oral) / (AUC0-inf iv/dose iv) * 100%, where AUC0-inf is the area under the concentration time curve (AUC) from time zero to infinity.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with investigational medicinal product (IMP) intake for the complete Part A.|||percentage bioavailability||90% Confidence Interval|Number
1356887|NCT01712711|Primary|Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment|Liver fat content was calculated by a valid formula. The formula is as the followings:Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 11 no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)|baseline and 6 weeks||||percentage of liver fat content||Standard Deviation|Mean
1356875|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
1356876|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of [14C]‐Pimasertib Following IV Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
1356877|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
1356878|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of [14C]‐Pimasertib Following Intravenous (IV) Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
1356879|NCT01712984|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1356880|NCT01712984|Secondary|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.|||Participants|||Number
1356881|NCT01712984|Secondary|Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1356882|NCT01712984|Primary|Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).|Day 28 post-vaccination|Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.|||Participants|||Number
1356883|NCT01712984|Primary|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1356884|NCT01712854|Secondary|Exercise Time in Steady State Exercise|Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.||||||
1356885|NCT01712854|Primary|The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).|Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.||||||
1356886|NCT01712776|Primary|Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)|NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)|Less than 10 minutes after stream application.|equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups|||units on a scale||Standard Deviation|Mean
1356889|NCT01712685|Secondary|Time to Peak Activity Derived From Time Activity Curve (TAC)|The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Minutes||Standard Deviation|Mean
1356890|NCT01712685|Secondary|Distribution Volume Ratio (DVR) for the Primary Kidney Lesions|DVR of the lesions was measured by the Logan graphical analysis method.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Distribution volume ratio||Standard Deviation|Mean
1356891|NCT01712685|Secondary|Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene|Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories.|21 days prior to enrollment until closure of the study, approximately 14 months.|5/11 participants had germline VHL testing with 4 having identifiable mutations of the VHL gene. 6/11 participants did not have germline VHL mutation testing due to low index of clinical suspicion although 2/6 had germline analysis for other gene mutations linked to familial renal cell carcinoma conditions.|||participants|||Number
1356892|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Normal Kidney|Mean SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Standard uptake value (SUV||Full Range|Mean
1356893|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC)|Mean SUV for primary clear cell renal carcinoma was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|Mean SUV for ccRCC after excluding Bosnial 3 Cyst (e.g. Bosnial 3 complex cyst) in one participant.|||Standard uptake value (SUV||Full Range|Mean
1356894|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for All Target Lesions|Mean SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Standard uptake value (SUV)||Full Range|Mean
1356895|NCT01712685|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|58 days||||participants|||Number
1356896|NCT01712685|Primary|Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)|"The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both non-tumor tissue."|58 days||||Standardized uptake value||Standard Error|Mean
1356897|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1356898|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||number of puffs||Standard Error|Least Squares Mean
1356899|NCT01712516|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1356917|NCT01712399|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
1356900|NCT01712516|Secondary|Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, 12 weeks|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1356901|NCT01712516|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1356902|NCT01712516|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1356903|NCT01712516|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1356904|NCT01712516|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 – 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
1356905|NCT01712516|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1356906|NCT01712516|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1356918|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).~Efficacy variables to be analyzed:~- Subject satisfaction"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.|||Percentage (%) of subjects|||Number
1356907|NCT01712516|Primary|Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.|||Liters||Standard Error|Least Squares Mean
1356908|NCT01712399|Primary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.|From Week 12 to Week 156 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||(mL/min/mmHg)||Standard Deviation|Mean
1356909|NCT01712399|Primary|Oxygen Saturation Levels by Pulse Oximetry|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|From Week 0 to Week 132 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Percent saturation||Standard Error|Mean
1356910|NCT01712399|Primary|Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE|Borg dyspnea score was a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.|From Week 0 to Week 132 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
1356911|NCT01712399|Primary|Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 156 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Participants|||Number
1356912|NCT01712399|Primary|Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 130 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Participants|||Number
1356913|NCT01712399|Primary|Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 130 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Participants|||Number
1356914|NCT01712399|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs|The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
1356915|NCT01712399|Primary|Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
1356916|NCT01712399|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
1362275|NCT01656850|Primary|HOMA at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||pg/mL||Standard Deviation|Mean
1356919|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:~- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.~Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:~- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS)."|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1356920|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).~Efficacy variables to be analyzed:~Complete cure~Treatment effectiveness~Mycological cure~Clinical success~Clinical cure"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.|||Percentage (%) of subjects (90% CI)||90% Confidence Interval|Number
1356921|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:~- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.~Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:~- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state"|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
1356922|NCT01712334|Primary|Safety: Number of Participants With Adverse Events During Each Treatment Period|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|4 Weeks|Safety population included all randomized participants who received treatment.|||participants|||Number
1356923|NCT01712334|Primary|Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed according to American Thoracic Society standards. FEV1 is the amount of air that is forced out of the lungs in one second and was measured at the end of each 2-week treatment period. The percent predicted FEV1 was calculated as: Percent predicted FEV1 =FEV1 (L) / Predicted FEV1 (L) ×100.|At the end of each 2-week treatment period|Modified Intent-to-Treat (mITT) population included all randomized participants with baseline and endpoint FEV1 values for both treatment periods.|||percent predicted||Standard Deviation|Mean
1356924|NCT01712256|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events|37 weeks||||participants|||Number
1356925|NCT01712256|Secondary|Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema|The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.|4 Weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||participants|||Number
1356926|NCT01712256|Secondary|Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration|The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.|4 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||participants|||Number
1356927|NCT01712256|Secondary|Vacc-4x Effect on Immune Response Measured as CD8 Count|Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1|36 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||cells/micro liter||Standard Deviation|Mean
1356928|NCT01712256|Secondary|Vacc-4x Effect on Immune Response Measured as CD4 Count|Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1|36 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||cells/micro liter||Standard Deviation|Mean
1356929|NCT01712256|Primary|Vacc-4x Effect on Viral Load Set-point|Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.|37 weeks|In the ITT population there were 20 evaluable subjects out of 30 (3 subjects did not receive ART from Screening through Week 12) and in the PP population there were 18 evaluable subjects out of 27 (an additional 3 subjects did not discontinue ART at Week 12).|||Copies/mL||Standard Deviation|Mean
1356930|NCT01712204|Primary|Number of Gout Flares Per Subject||16 weeks||||flares||95% Confidence Interval|Least Squares Mean
1356931|NCT01712178|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing “no pain” and 100 representing “worst possible pain”. Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study.|Immediately after injections on Day 1||||Millimeters||Standard Deviation|Mean
1356932|NCT01712178|Secondary|Number of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.|From time of informed consent to 70 days following the last dose of study drug||||participants|||Number
1356934|NCT01712178|Secondary|Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24|The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Error|Least Squares Mean
1356935|NCT01712178|Secondary|Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Error|Least Squares Mean
1356936|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||percentage of participants|||Number
1356937|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||percentage of participants|||Number
1356938|NCT01712178|Primary|Mean Disease Activity Scores (DAS28) at Weeks 12 and 24|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Error|Least Squares Mean
1356939|NCT01712178|Primary|Serum Concentrations of Adalimumab at Weeks 12 and 24|Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.|Measured at Weeks 12 and 24|Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.|||µg/mL||Standard Deviation|Mean
1356940|NCT01712074|Other Pre-specified|Participants in Each Category of C-CASA Mapped From the C-SSRS Responses|"Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.~C-CASA Event Code: <1> Completed suicide; <2> Suicide attempt; <3> Preparatory acts towards imminent suicidal behavior; <4> Suicidal Ideation; <7> Self-injurious behavior, no suicidal intent.~The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).~Only participants falling any category of C-CASA events were listed below."|From Screening to Week 18/Early Termination|All participants screened and assigned|||Participants|||Number
1356941|NCT01712074|Other Pre-specified|Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern|Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
1357495|NCT01708057|Primary|Change From Baseline in Peak FEV1 (0-24h)|The maximum value over 24 hours post-dose, as change from baseline|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have been analysed.||||||
1356942|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)|The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||bpm||Full Range|Mean
1356943|NCT01712074|Other Pre-specified|BP Changes From Baseline - Week 16/Early Termination (Visit 5)|The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||mmHg||Full Range|Mean
1356944|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 10 (Visit 4)|The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||bpm||Full Range|Mean
1356945|NCT01712074|Other Pre-specified|BP Changes From Baseline - Week 10 (Visit 4)|The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||mmHg||Full Range|Mean
1356946|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 6 (Visit 3)|The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||beats per minute (bpm)||Full Range|Mean
1356947|NCT01712074|Other Pre-specified|Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)|The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||millimeters of mercury (mm Hg)||Full Range|Mean
1356948|NCT01712074|Other Pre-specified|Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern|"Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.~Participants with a post-baseline QTcF absolute value of 450 - <480, 480 - <500, or >=500 mec, or with a post-baseline QTcF increase of 30 - <60 or >=60 msec were counted."|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
1356949|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356950|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356951|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356952|NCT01712074|Other Pre-specified|Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern|Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value>=100 msec , a QRS complex increase of >=25% (for participants with a baseline value>=100 msec), or with an increase >=50% (for participants with a baseline value<100 msec) were counted.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of participants|||Number
1356953|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356954|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356955|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356956|NCT01712074|Other Pre-specified|Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern|Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value>=300 msec , a PR increase of >=25% (for participants with a baseline value>=200 msec), or with an increase >=50% (for participants with a baseline value<200 msec) were counted.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
1357260|NCT01709708|Secondary|Overall Satisfaction|Satisfaction scores Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B). Satisfaction scores are a likert scale ranging from 1 to 5 with 1 being complete dissatisfaction and 5 being complete satisfaction.|10 Weeks||||units on a scale||Standard Deviation|Mean
1356957|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356958|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
1356959|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||milliseconds (msec)||Full Range|Mean
1356960|NCT01712074|Other Pre-specified|Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period|"Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.~The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1)."|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
1356961|NCT01712074|Other Pre-specified|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation|Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent|Week 4 to Week 18|All participants who received any treatment during double blind period|||Percentage of Participants|||Number
1356962|NCT01712074|Secondary|Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)|The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.|Baseline and Week 16|The FAS is defined as all participants who are randomized. The FAS was the primary analysis set for efficacy data.|||scores on a scale||Standard Error|Least Squares Mean
1356963|NCT01712074|Primary|Change From Baseline in ADAS-cog13 Total Score at Week 16|ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.|Baseline and Week 16|The Full Analysis Set (FAS) is defined as all participants who were randomized. The FAS was the primary analysis set for efficacy data.|||scores on a scale||Standard Error|Least Squares Mean
1356964|NCT01712061|Other Pre-specified|Number of Participants With Increased Fasting Blood Glucose||Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||participants|||Number
1356965|NCT01712061|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.|Baseline up to 28 days after last study drug administration|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.|||participants|||Number
1356966|NCT01712061|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|Criteria for potentially clinically important ECG values were defined as: PR interval >=300 milliseconds (msec) or >=25%/50% increase when baseline is >200 msec and ≥50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); QTc >=450 msec or >=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline, Weeks 1, 4 and 12|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||participants|||Number
1356979|NCT01712061|Primary|Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline and Week 12|The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||percent (%)||95% Confidence Interval|Mean
1357277|NCT01709695|Primary|Go/No-go Task Performance Correct Inhibitions|Measures of go/no-go task performance during functional magnetic resonance imaging. Performance on a go-nogo task inside the scanner.|Baseline and 8 weeks||||percentage correct inhibitions||Standard Deviation|Mean
1356967|NCT01712061|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).|Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||participants|||Number
1356968|NCT01712061|Other Pre-specified|Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||kilograms (kg)||Standard Deviation|Mean
1356969|NCT01712061|Other Pre-specified|Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||beats per minute (bpm)||Standard Deviation|Mean
1356970|NCT01712061|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
1356971|NCT01712061|Secondary|Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12||1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12|The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1356972|NCT01712061|Secondary|Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||percent||Standard Deviation|Mean
1356973|NCT01712061|Secondary|Change From Baseline in Serum Cystatin C at Weeks 12 and 16|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mg/dL||Standard Deviation|Mean
1356974|NCT01712061|Secondary|Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1356975|NCT01712061|Secondary|Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16|Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mL/min/1.73m^2||Standard Deviation|Mean
1356976|NCT01712061|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mL/min/1.73m^2||Standard Deviation|Mean
1356977|NCT01712061|Secondary|Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16|The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mg/mmolCr||Geometric Coefficient of Variation|Geometric Mean
1356978|NCT01712061|Secondary|Change From Baseline in UACR at Weeks 4, 8 and 16|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mg/millimolar creatinine (mmolCr)||Geometric Coefficient of Variation|Geometric Mean
1358296|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
1356980|NCT01712009|Secondary|Number of Participants With Adverse Events (AEs)|"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.~The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies."|From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.|Safety analysis set included all participants who received primary prophylaxis with pegfilgrastim according to the prophylactic medication actually received. Participants in the Naproxen or Loratadine groups who did not receive naproxen or loratadine are analyzed in the No Prophylaxis group for safety analyses.|||participants|||Number
1356981|NCT01712009|Secondary|Area Under the Curve (AUC) for Patient-reported Bone Pain|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."|||units on a scale * days||Standard Error|Least Squares Mean
1356982|NCT01712009|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant’s bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."|||units on a scale||Standard Error|Least Squares Mean
1356983|NCT01712009|Secondary|Mean Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant’s bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."|||units on a scale||Standard Error|Least Squares Mean
1356984|NCT01712009|Secondary|Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles|Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."|||percentage of participants||95% Confidence Interval|Number
1356985|NCT01712009|Secondary|Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."|||percentage of participants||95% Confidence Interval|Number
1356986|NCT01712009|Primary|Percentage of Participants With Bone Pain (All Grades) in Cycle 1|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)|Full anlysis set|||percentage of participants||95% Confidence Interval|Number
1356987|NCT01711918|Secondary|Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
1356988|NCT01711918|Secondary|Improvement of Abdominal Bloating or Distention Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
1356989|NCT01711918|Secondary|Improvement of Vomiting Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
1356990|NCT01711918|Secondary|Improvement of Nausea Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
1356991|NCT01711918|Primary|Improvement of Overall Symptoms Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
1357044|NCT01711424|Primary|Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®|Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.|||Participants|||Number
1372760|NCT01536093|Secondary|Concentration of Urinary IL-1 Beta||2 weeks of age||||ug per g creatinine||Standard Deviation|Mean
1356992|NCT01711866|Secondary|Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit|"The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:~1 = Very much improved~2 = Much improved~3 = Minimally improved~4 = No change~5 = Minimally worse~6 = Much worse~7 = Very much worse."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 35.|||participants|||Number
1356993|NCT01711866|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:~0 = Side effects not assessable~1 = No side effects~2 = Side effects do not significantly interfere with subject’s functioning~3 = Side effects significantly interfere with the subject’s functioning~4 = Side effects outweigh therapeutic efficacy."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|All 87 subjects of the Safety Set are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.|||participants|||Number
1356994|NCT01711853|Primary|AUCtau,ss|"Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1356995|NCT01711853|Primary|Cmax,ss|"Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1356996|NCT01711736|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1356997|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1356998|NCT01711736|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1356999|NCT01711736|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1357000|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1357001|NCT01711736|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1358297|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1357002|NCT01711736|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||subjects|||Number
1357003|NCT01711736|Secondary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||subjects|||Number
1357004|NCT01711736|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1357005|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1357006|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).|Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1357007|NCT01711736|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1357008|NCT01711736|Primary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||subjects|||Number
1357009|NCT01711645|Secondary|Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.|Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.||||||
1357010|NCT01711645|Secondary|Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day|Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.||||||
1359609|NCT01683604|Secondary|Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs||Baseline|FAS population.|||percentage of participants|||Number
1357011|NCT01711645|Secondary|Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.|Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.||||||
1357012|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.|Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination|The laboratory staff was not successful in attempts to conduct the ELISA assay against the pertactin and fimbrae antigens with the breast milk samples.||||||
1357013|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Month 6.|Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|6 months post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357014|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Week 6.|Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
1357015|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Week 2.|Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|2 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357016|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Baseline.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|Baseline (prior to vaccination)|All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357017|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Month 6|Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 months post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
1357018|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Week 6|Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
1357019|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Week 2|Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|2 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
1357020|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of <10 were reported as half the LLOQ (5).|Baseline (prior to vaccination)|All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357021|NCT01711645|Primary|Kinetics of the ELISA IgG Antibody Rise in Serum|The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.|Prior to and following Tdap, through 24 months post-vaccination|No analysis was conducted for this outcome measure. See previous outcome measures for geometric mean fold rises at each timepoint.||||||
1363377|NCT01644240|Primary|t½|Time to 50% plasma concentration|Day 1|Subjects did not meet extrapolation criteria and were not included in the analysis.|||hours||Standard Deviation|Mean
1357022|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 24 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
1357023|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 18 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
1357024|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 12 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
1357025|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 6 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
1357026|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 6 weeks after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
1357027|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 2 weeks after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
1357028|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24|Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|24 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357029|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18|Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|18 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357030|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12|Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|12 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357031|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6|Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|6 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357635|NCT01706159|Secondary|Number of Adverse Events (AEs)|Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.|Week 0 to 10|Safety analysis set included all randomised and treated subjects.|||events|||Number
1357032|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6|Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|6 weeks post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357033|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2|Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|2 weeks post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357034|NCT01711645|Primary|ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline|Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (<10 EU/mL). The geometric mean of participants’ concentrations at the timepoint was calculated, along with the 95% CI.|Baseline (prior to vaccination)|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
1357035|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24|Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 24 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
1357036|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18|Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 18 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
1357037|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12|Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 12 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
1357038|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6|Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 6 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
1357039|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6|Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 6 weeks following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
1357040|NCT01711645|Primary|Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2|Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).|Prior to and 2 weeks following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
1357041|NCT01711424|Secondary|Schirmer Score|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.|||mm/5 min||Full Range|Median
1357042|NCT01711424|Secondary|Tear Break Up Time (TBUT)|TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.|||Seconds||Full Range|Median
1357043|NCT01711424|Secondary|Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®|The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.|||Participants|||Number
1363378|NCT01644240|Primary|Tmax|Time to maximum plasma concentration|Day 1||||hours||Full Range|Median
1357045|NCT01711359|Secondary|Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1357046|NCT01711359|Secondary|Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1357047|NCT01711359|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and an observed value at the time point being summarized.|||Percentage of Impairment||Standard Deviation|Mean
1357048|NCT01711359|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scores|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357049|NCT01711359|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||millimeter||Standard Deviation|Mean
1357050|NCT01711359|Secondary|Change From Baseline in European Quality of Life–5 Dimensions–5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357051|NCT01711359|Secondary|Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357052|NCT01711359|Secondary|Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357053|NCT01711359|Secondary|Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357658|NCT01705574|Secondary|Percentage of Participants Receiving E/C/F/TDF or ATV+RTV+FTC/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase||Open-Label Extension Week 48|||||||
1386249|NCT01394159|Secondary|Diagnosis Achieved With the Needle||6 months||||participants|||Number
1357054|NCT01711359|Secondary|Change From Baseline in Duration of Morning Joint Stiffness|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Minutes||95% Confidence Interval|Median
1357055|NCT01711359|Secondary|Change From Baseline in Joint Space Narrowing and Bone Erosion Scores|X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.|||units on a scale||Standard Deviation|Mean
1357056|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission|"The ACR/EULAR definitions of RA remission include a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1357057|NCT01711359|Secondary|Change From Baseline in Disease Activity Score 28–Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357058|NCT01711359|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).|||units on a scale||Standard Deviation|Mean
1357059|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|"ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of participants|||Number
1357060|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of participants|||Number
1357070|NCT01711216|Secondary|Change of Intensity of Anxiety|Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||units on a scale||Standard Deviation|Mean
1357061|NCT01711359|Secondary|Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1357062|NCT01711359|Secondary|Change From Baseline in the Modified Total Sharp Score (mTSS)|"X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.~The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448."|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).|||units on a scale||Standard Deviation|Mean
1357063|NCT01711359|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||units on a scale||Standard Deviation|Mean
1357064|NCT01711359|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||units on a scale||Standard Deviation|Mean
1357065|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 52|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).|||Percent of participants|||Number
1357066|NCT01711359|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 24|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).|||Percent of participants|||Number
1357067|NCT01711216|Secondary|Time to Relapse|The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.|Up to 6 months or longer after ended treatment|"Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.~Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (>85%) maintained regular cycles for the whole follow-up period"|||percentage of subjects|||Number
1357068|NCT01711216|Primary|Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.|||participants|||Number
1357069|NCT01711216|Primary|Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.|||participants|||Number
1357749|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
1357071|NCT01711216|Secondary|Change of Pain Intensity During Menstruation|Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||units on a scale||Standard Deviation|Mean
1357072|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS.|||days||Standard Deviation|Mean
1357073|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS.|||days||Standard Deviation|Mean
1357074|NCT01711216|Secondary|Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||percentage of subjects|||Number
1357075|NCT01711216|Secondary|Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 9 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||percentage of subjects|||Number
1357076|NCT01711216|Secondary|Overall Clinical Response on Treatment Assessed by Physician|Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.|||participants|||Number
1357077|NCT01711216|Secondary|Patient Satisfaction With the Treatment|Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.|||participants|||Number
1357078|NCT01711216|Secondary|Change of Intensity of Anxiety From Baseline to the End of Treatment|Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing.|||units on a scale||Standard Deviation|Mean
1357079|NCT01711216|Secondary|Change of Pain Intensity During Menstruation From Baseline to End of Treatment|Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing|||units on a scale||Standard Deviation|Mean
1357080|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS|||days||Standard Deviation|Mean
1357081|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea|Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS|||days||Standard Deviation|Mean
1357082|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS|||days||Standard Deviation|Mean
1357083|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea|Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS|||days||Standard Deviation|Mean
1357084|NCT01711216|Secondary|Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles|Up to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles|||percentage of subjects|||Number
1357085|NCT01711177|Primary|Blood Oxygenation|For each subject, all the measurements will be done during an 1 hour appointment.|1 hour||||percentage of oxygenation||95% Confidence Interval|Mean
1372761|NCT01536093|Secondary|Concentration of Urinary Lactoferrin||1 week of age||||ug per g creatinine||Standard Deviation|Mean
1357086|NCT01710839|Secondary|Visual Field|Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots.|6 and 12 Months|Patients who completed GVF testing at baseline, M6, and M12 with adequate fixation and cooperation during testing were included in GVF analyses (n=14)|||square degrees||Standard Error|Mean
1357087|NCT01710839|Secondary|Aqueous VEGF Levels|VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit.|12 Months|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.||||||
1357088|NCT01710839|Secondary|Central Foveal Outcome|Mean change in Central Foveal Volume on High Resolution OCT.|12 months|1 patient withdrew from the study before month 12|||cubic millimeters||Standard Deviation|Mean
1357089|NCT01710839|Secondary|Neovascularization of the Iris, Optic Nerve and Elsewhere|Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.|12 months||||percentage of patients|||Number
1357090|NCT01710839|Secondary|Adverse Events|Incidence and severity of adverse events (ocular and non-ocular).|12 months||||Participants|||Count of Participants
1357091|NCT01710839|Secondary|Foveal Avascular Zone|Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram|12 months|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.||||||
1357092|NCT01710839|Secondary|Retinal Ischemia|Quantify change in area of perfused and ischemic retina.|12 month period|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.||||||
1357093|NCT01710839|Primary|Visual Acuity|Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.|12 month period|1 patient withdrew from the study before month 12|||ETDRS BCVA Letters||Standard Error|Mean
1357094|NCT01710839|Primary|Total Number of Intravitreal Injections Over a 12 Month Period|Assess the number of intravitreal injections over 12 months.|12 months||||injections||Full Range|Mean
1357095|NCT01710800|Primary|Number of Impedance Episodes Following PPI and Placebo|Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.|1 week|We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.|||number of episodes||Standard Deviation|Mean
1357096|NCT01710787|Secondary|Intraoral Soft-tissue Anesthesia (Onset and Duration)|Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints|up to 120 mins post-dose|The analysis population includes patients who received a rescue injection of local anesthetic. Local anesthetic may cause soft-tissue anesthesia, impacting this endpoint. In addition, only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.|||minutes||Standard Deviation|Mean
1357097|NCT01710787|Secondary|Alcohol Sniff Test|The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.|administered at baseline, 120 minutes and approximately 24 hours after drug administration||||cm||Standard Deviation|Mean
1357098|NCT01710787|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1357099|NCT01710787|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1357100|NCT01710787|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration||||beats per minute||Standard Deviation|Mean
1357101|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1357102|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mm Hg||Standard Deviation|Mean
1357103|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
1357104|NCT01710787|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg||at any time within 120 minutes following drug administration||||participants|||Number
1357105|NCT01710787|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1357106|NCT01710787|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1357107|NCT01710787|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1357108|NCT01710787|Secondary|Number of Participants With a Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1357109|NCT01710787|Secondary|Number of Participants With a Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1357110|NCT01710787|Secondary|Intraoral Soft-tissue Anesthesia (Yes/no)|Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints|at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window|Only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.|||Participants|||Count of Participants
1358750|NCT01692782|Secondary|The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.||Weeks 1, 2, 3, 4|Intent to treat|||participants|||Number
1357111|NCT01710787|Primary|Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 15 minutes with a 3 minute window||||percentage of patients||95% Confidence Interval|Number
1357112|NCT01710709|Secondary|Percentage of Participants Who Remained Stable at End of Treatment in Phase C|The secondary objective was to evaluate the efficacy, as measured by the percentage of stable participants at baseline who remained stable at the end of treatment in the IM depot maintenance phase, of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to subjects with bipolar I disorder.|Up to Week 52|IM Depot Maintenance Phase Efficacy Sample: All participants who entered the IM Depot Maintenance Phase, received at least 1 dose of aripiprazole IM depot, and had at least 1 post-baseline efficacy evaluation in the IM Depot Maintenance Phase. Number analyzed is the number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
1357113|NCT01710709|Primary|Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating|Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe) . The participant indicated the degree of pain at the most recent injection site using a VAS. Ratings ranged from 0 (no pain) to 100 (unbearably painful). Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. These assessments occurred at trial visits where injections occurred (scheduled and unscheduled), beginning with the first dose of open-label aripiprazole IM depot administered at the final visit of the Oral Stabilization Phase and continued through the last injection prior to the end of the IM Depot Maintenance Phase/Early termination (ET) visit (ie, evaluations were not done at end of the IM Depot Maintenance Phase/ET visit).|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
1357114|NCT01710709|Primary|Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS)|Suicidality was monitored throughout the trial using the C-SSRS at every visit. The C-SSRS scale consisted of a screening/baseline evaluation that assessed the participant's lifetime experience and experience over the last 90 days with suicide events and suicidal ideation and a post-baseline/ “Since Last Visit” evaluation that focused on suicidality since the last trial visit.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
1357115|NCT01710709|Primary|Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS)|AIMS: 10 items described dyskinesia signs; 0-absence/no awareness; 4-severe condition/severe distress. Total score for Items 1-10 ranges from 0 to 40; a higher score reflects severe condition. SAS:Consisted of 10 parkinsonism signs;1-no symptoms;5-severe.Total score for Items 1-10 ranges from 1 to 50;a higher score reflects severe condition.DIEPSS:A 9-item rating scale (8 assessed individual symptoms [4 categories of parkinsonism, akathisia, dystonia & dyskinesia]+1 assessed general severity) was used;0-no symptoms/normal, 4-severe.Total score (8 individual symptom items) was in range of 0 to 32 (a higher score reflects severe condition).BARS:Consisted of 4 items related to akathisia:objective observation, subjective feelings of restlessness, distress, global clinical evaluation.Only BARS global clinical assessment score has been presented and rated using scale:0-absence of symptoms;5-severe akathisia.Total BARS global score ranges from 0 to 5,a higher score reflects severe condition.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Units on a scale||Standard Deviation|Mean
1357116|NCT01710709|Primary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs)|Twelve-lead ECGs were recorded at specified visits. For each time point, three 12-lead ECG recordings were obtained approximately 5 minutes apart. Additional 12-lead ECGs were permitted to be obtained at the investigator’s discretion and were to always be obtained in the event of an early termination. The ECGs were evaluated at the investigational site to determine the participant’s eligibility and to monitor safety during the trial.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
1357117|NCT01710709|Primary|Number of Participants With Clinically Significant Abnormal Vital Signs|TEAEs of potential clinical relevance included abnormal values in body weight, systolic and diastolic blood pressure, heart rate, and body temperature that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
1357118|NCT01710709|Primary|Number of Participants With Clinically Significant Abnormal Laboratory Test Results|Standard safety variables to be analyzed included clinical laboratory tests. Incidence of treatment emergent adverse events (TEAEs) of potential clinical relevance included abnormal values in serum chemistry, hematology, urinalysis, and other laboratory test that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as serious adverse event/adverse events (SAE/AEs) and are reported in the SAE/other AE section of this report.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
1357119|NCT01710709|Primary|Injection Site Pain Measured by the Visual Analog Scale (VAS)|Injection-site pain was evaluated by mean visual analog scale (VAS) scores as reported by the participant after each injection at visits where an injection occurred. Ratings ranged from 0 (no pain) to 100 (unbearably painful).|Up to Week 52|"All participants who received at least one dose of aripiprazole IM depot in Phase C. It is equivalent to safety set (SAF) for Phase C.~Number analyzed = Total number of participants with at least one observation of the given parameter."|||Units on a scale||Standard Deviation|Mean
1372762|NCT01536093|Secondary|Salivary IL-8 Concentration at 2 Weeks of Age||2 weeks of age||||ng/mL||Standard Deviation|Mean
1357120|NCT01710709|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP). AEs were assessed as a criteria for safety and tolerability.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. TEAEs = Treatment-emergent adverse events. discount. = discontinued (used in the table below)|||Participants|||Count of Participants
1357121|NCT01710657|Secondary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)|"Partial-onset seizure (POS) frequency per 28 days was calculated as:~POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.~A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period."|8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||Seizures per 28 days||Full Range|Median
1357122|NCT01710657|Secondary|Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.|8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||percentage change||Full Range|Median
1357123|NCT01710657|Secondary|The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)||8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||participants|||Number
1357124|NCT01710657|Primary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|"Partial-onset seizure (POS) frequency per 28 days was calculated as:~POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.~A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period."|8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||Seizures per 28 days||Full Range|Median
1357125|NCT01710527|Secondary|Assessment of Subject Well-being Questionnaire|Subject well-being questionnaire was planned to be conducted at 1.0 and 5.0 hour post-dose. During vital sign recording each participants was planned to be asked about his well-being recorded during post study safety assessments. The data for this outcome measure was not collected during the study. Thus the results summary for this outcome measure was not produced.|Up to 38 days|Safety population.||||||
1357126|NCT01710527|Secondary|Number of Participants With Abnormal Periodic Physical Examination Results|Brief physical examination was performed at each check-in, check-out and complete physical examination during screening and at the end of the clinical part of the study.|Up to 38 days|Safety population.|||Participants|||Number
1357127|NCT01710527|Secondary|Number of Participants With Abnormal Vital Sign Results|Vital signs measurements (blood pressure, respiratory rate, pulse rate and oral temperature) were conducted during screening and during post study safety assessments. Vital signs measurement were also performed at each check-in and at checkout and were also recorded before dosing of study drug, between 2-3, 9–10 and 36.0 hour post-dose. Measurements were recorded in sitting position after rest of at least 5 min.|Up to 38 days|Safety population.|||Participants|||Number
1357128|NCT01710527|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to 38 days|Safety population was defined as participants who received at least one dose of the study drug.|||Participants|||Number
1357129|NCT01710527|Primary|Apparent First-order Elimination or Terminal Rate Constant|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semi logarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||1/hour||Standard Deviation|Mean
1357130|NCT01710527|Primary|Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUC%_Extrapolated)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC%_Extrapolated was obtained by subtracting AUC0-t from AUC0-infinity divided by AUC0-infinity and multiplied by 100.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||Percentage of area||Standard Deviation|Mean
1357750|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full Analysis set|||symptom free days||90% Confidence Interval|Least Squares Mean
1357131|NCT01710527|Primary|Terminal Half-life (T-half) Over Period|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with elimination rate constant obtained as semi logarithmic plot of the plasma concentration versus time.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||hour||Standard Deviation|Mean
1357132|NCT01710527|Primary|Time of the Maximum Plasma Concentration (T-max) Over Period|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||hour||Standard Deviation|Median
1357133|NCT01710527|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|"Plasma samples for PK analysis were drawn at indicated time points of each treatment period.~AUC0-t was calculated by the linear trapezoidal rule from measured data points from time of administration until the time of last quantifiable concentration. AUC0- infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant. The AUC0- infinity was the sum of the estimated and extrapolated parts."|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||ng*hour/mL||Standard Deviation|Mean
1357134|NCT01710527|Primary|Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population was defined as all participants who had a PK measurement available. Data is presented for the participants available at the time of assessment.|||Nanogram per milliltre (ng/mL)||Standard Deviation|Mean
1357135|NCT01710514|Secondary|Blood Progesterone Concentration||Weeks 2, 4, 5, 8, and end of study|FAS population|||ng/mL||Standard Deviation|Mean
1357136|NCT01710514|Secondary|Clinical Pregnancy Rate|Defined as presence of a gestational sac on transvaginal ultrasound|Week 4 of study|FAS with ET population|||percentage of participants||95% Confidence Interval|Number
1357137|NCT01710514|Secondary|Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG)||Week 2 of study|FAS with ET population In the TID group 13 subjects had a positive beta-hCG assessment while 14 subjects had a positive clinical pregnancy at Week 4. This is because one subject had a negative beta-hCG at Week 2, but she had a positive local serum hCG on the same day and continued the trial. Then clinical and ongoing pregnancy were confirmed.|||percentage of participants||95% Confidence Interval|Number
1357138|NCT01710514|Primary|Ongoing Pregnancy Rate|Defined as identification of fetal survival and fetal heart movements on transvaginal ultrasound|Week 5 of study|FAS with ET population|||percentage of participants||95% Confidence Interval|Number
1357139|NCT01710514|Primary|The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml||Day 5 of treatment|FAS population|||percentage of subjects||95% Confidence Interval|Number
1357140|NCT01710501|Secondary|Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response|Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.|From Day 1 up to Follow-up Week 24 (up to 48 weeks total)|Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.|||participants|||Number
1357141|NCT01710501|Secondary|Percentage of Subjects Achieving SVR24|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.|24 weeks after end of treatment (up to 48 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
1357142|NCT01710501|Secondary|Percentage of Participants Achieving SVR4|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.|4 weeks after end of treatment (up to 28 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
1357143|NCT01710501|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|From TW 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
1357203|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||mg/L||Standard Deviation|Mean
1357144|NCT01710501|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL.|From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
1357145|NCT01710501|Primary|Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|Up to 24 weeks|APaT Population; all randomized participants who received at least one dose of study treatment.|||participants|||Number
1357146|NCT01710501|Primary|Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event.|14 days following last dose of study drug (up to 26 weeks)|All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.|||participants|||Number
1357147|NCT01710501|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.|12 weeks after end of treatment (up to 36 weeks total)|Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
1357148|NCT01710358|Secondary|Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole*hr/Liter (nmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
1357149|NCT01710358|Secondary|Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1357150|NCT01710358|Secondary|Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores|"X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion)."|Baseline, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.|||units on a scale||Standard Deviation|Mean
1357151|NCT01710358|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 12, Week 24, Week 52|mITT population includes all randomized participants who received at least 1 dose of the study drug, with a baseline value and an observed value at the time point being summarized.|||percentage of impairment||Standard Deviation|Mean
1357330|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
1357152|NCT01710358|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||millimeter||Standard Deviation|Mean
1357153|NCT01710358|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357154|NCT01710358|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357155|NCT01710358|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
1357156|NCT01710358|Secondary|Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
1357157|NCT01710358|Secondary|Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine. Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
1357158|NCT01710358|Secondary|Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents no joint stiffness and 10 represents joint stiffness as bad as you can imagine. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
1357159|NCT01710358|Secondary|Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries|Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||Minutes||95% Confidence Interval|Median
1357346|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Fasting triglycerides ITT population.|||percent change||Standard Error|Mean
1357160|NCT01710358|Secondary|Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission – Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1357161|NCT01710358|Secondary|Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1357162|NCT01710358|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).|||units on a scale||Standard Deviation|Mean
1357163|NCT01710358|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response|"ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.~Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
1357164|NCT01710358|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||units on a scale||Standard Deviation|Mean
1357165|NCT01710358|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||units on a scale||Standard Deviation|Mean
1357166|NCT01710358|Secondary|Change From Baseline in the Modified Total Sharp Score (mTSS)|"X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.~The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448."|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).|||units on a scale||Standard Deviation|Mean
1357187|NCT01710046|Secondary|Psoriasis Area and Severity Index (PASI) Score by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Baseline and Weeks 1, 2, 4, and 12|FAS; n (number) =number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
1372763|NCT01536093|Secondary|Salivary TGF-beta 1 Concentration at 2 Week of Age||2 week of age||||ug/mL||Standard Deviation|Mean
1357167|NCT01710358|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders."|Week 12|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).|||percentage of participants|||Number
1357168|NCT01710345|Primary|SPID-12|"The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.~The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better."|12 hours||||units on a scale||Standard Error|Least Squares Mean
1357169|NCT01710332|Secondary|Change in Vision Based on Letter Score|• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score|6 months||||ETDRS letters||Standard Deviation|Mean
1357170|NCT01710332|Primary|Safety of Intravitreal Aflibercept Injection|Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.|6 months||||adverse events|||Number
1357171|NCT01710254|Secondary|Accuracy of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)|Determination of accuracy of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Accuracy is the percentage of correctly classified subjects (true positive + true negative) among all subjects (true positive + true negative + false positive + false negative). Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.|one MRI, up to 1 hour|Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers|||Percentage of correct total cases||95% Confidence Interval|Number
1357172|NCT01710254|Primary|Specificity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)|Determination of specificity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.|one MRI, up to 1 hour|Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers|||Percentage of true negative cases||95% Confidence Interval|Number
1357173|NCT01710254|Primary|Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)|Determination of sensitivity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.|one MRI, up to 1 hour|Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers|||Percentage of true positive cases||95% Confidence Interval|Number
1357174|NCT01710046|Secondary|Percent Change From Baseline in TPSS by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percent change from baseline||Standard Error|Mean
1357175|NCT01710046|Secondary|Target Plaque Severity Score (TPSS) by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||score on a scale||Standard Error|Mean
1357176|NCT01710046|Secondary|Change From Baseline in ISI by Visit|"ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement."|Weeks 1, 2, 4 and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
1357177|NCT01710046|Secondary|Itch Severity Item (ISI) Score by Visit|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15."|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
1357188|NCT01710046|Primary|"Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.|Week 12|FAS|||percentage of participants|||Number
1357178|NCT01710046|Secondary|Percent Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percent change from baseline||Standard Error|Mean
1357179|NCT01710046|Secondary|Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.||||||
1357180|NCT01710046|Secondary|Body Surface Area (BSA)|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||% BSA||Standard Error|Mean
1357181|NCT01710046|Secondary|Percentage of Participants by PGA Response Category and Timepoint|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percentage of participants|||Number
1357182|NCT01710046|Secondary|Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category||Baseline and Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.||||||
1357183|NCT01710046|Secondary|Change From Baseline in PGA Score by Visit|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
1357184|NCT01710046|Secondary|Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4|Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Weeks 1, 2, and 4|FAS|||percentage of participants|||Number
1357185|NCT01710046|Secondary|Percent Change From Baseline in PASI by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percent change from baseline||Standard Error|Mean
1357186|NCT01710046|Secondary|Change From Baseline in PASI by Visit|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€“100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease.|Weeks 1, 2, 4 and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.||||||
1372764|NCT01536093|Secondary|Urinary Secretary IgA Concentration at 1 Week of Age||1 week of age||||ng per g creatinine||Standard Deviation|Mean
1357189|NCT01710046|Primary|Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12|Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Week 12|FAS|||percentage of participants|||Number
1357190|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 57|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357191|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 29|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357192|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 15|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357193|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 8|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357194|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Baseline|The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357195|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 57|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357196|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 29|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357197|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 15|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357198|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 8|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357199|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Baseline|The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357200|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||mg/L||Standard Deviation|Mean
1357201|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||mg/L||Standard Deviation|Mean
1357202|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||mg/L||Standard Deviation|Mean
1357347|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1357204|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline|Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||Milligram per Liter (mg/L)||Standard Deviation|Mean
1357205|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Standard Deviation|Mean
1357206|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Standard Deviation|Mean
1357207|NCT01710033|Primary|Accumulation Ratio (Rac) For CP-690,550|Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ratio||Standard Deviation|Mean
1357208|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Full Range|Median
1357209|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Full Range|Median
1357210|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
1357211|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1357212|NCT01710033|Primary|Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng*hr/mL||Standard Deviation|Mean
1357213|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng*hr/mL||Standard Deviation|Mean
1357214|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1357215|NCT01710020|Other Pre-specified|Dialyser Clearance (CL HD) From 3 to 3.5 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
1357216|NCT01710020|Other Pre-specified|Overall Dialyser Clearance (CL HD)|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
1357217|NCT01710020|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|2 hours post-dose in Period 1|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1357348|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Lipoprotein (a) ITT population.|||percent change||Standard Deviation|Mean
1357218|NCT01710020|Primary|Dialyser Clearance (CL HD) From 3 to 4 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
1357219|NCT01710020|Primary|Dialyser Clearance (CL HD) From 2 to 3 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
1357220|NCT01710020|Primary|Dialyser Clearance (CL HD) From 1 to 2 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
1357221|NCT01710020|Primary|Dialyser Clearance (CL HD) From 0 to 1 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
1357222|NCT01710020|Primary|Oral Clearance (CLpo)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||milliliter/minute (mL/min)||Standard Deviation|Mean
1357223|NCT01710020|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||hr||Standard Deviation|Mean
1357224|NCT01710020|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||hr||Full Range|Median
1357225|NCT01710020|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1357226|NCT01710020|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||ng*hr/mL||Standard Deviation|Mean
1357227|NCT01710020|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1|Analysis set included all participants who received study medication.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1357228|NCT01709903|Secondary|Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment|Percentage of nights with 'no nighttime awakenings', percentage of days with 'no daytime symptoms', and percentage of 'days able to perform usual daily activities' over 26 weeks (FAS)|26 weeks|Full Analysis Set|||% days in study||Standard Error|Least Squares Mean
1357229|NCT01709903|Secondary|Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals|"The number of puffs of rescue medication taken in the previous 12 hours will be recorded in the Patient Diary in the morning and evening. Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point. Less puffs taken is better."|12 and 26 weeks|Full Analysis set|||# of puffs||Standard Deviation|Mean
1357230|NCT01709903|Secondary|Analysis of the TDI Focal Score Over the Whole Treatment Period|"The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. .Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point."|12 and 26 weeks|Full Analysis Set|||Numbers on a scale||Standard Error|Least Squares Mean
1357243|NCT01709864|Secondary|"Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. Percentage of no nighttime awakenings from Baseline up to 12 weeks."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||percentage of nights||Standard Error|Least Squares Mean
1357751|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set|||symptom free days||90% Confidence Interval|Least Squares Mean
1357231|NCT01709903|Secondary|Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|26 weeks|Full Analysis set|||numbers on a scale||Standard Error|Mean
1357232|NCT01709903|Secondary|Analysis of Trough FVC (L) Over the Whole Treatment Period|Average of Trough Forced Vital Capacity (FVC) at 23 hours 15 min and the 23 hours 45 min post dose|12 and 26 weeks|Full Analysis Set|||liter||Standard Error|Least Squares Mean
1357233|NCT01709903|Secondary|Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period|Average of Trough Forced Expiratory Volume in one second (FEV1)|6,12,18 and 26 weeks|Full analysis set|||liter||Standard Error|Least Squares Mean
1357234|NCT01709903|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 1, 12 and 26 weeks|Full Analysis set|||Liter||Standard Deviation|Mean
1357235|NCT01709903|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Superiority of QVA 110/50μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d||26 weeks|FAS|||liters||Standard Error|Least Squares Mean
1357236|NCT01709903|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d|Measurement of QVA149 110/50 μg o.d. to fluticasone/salmeterol 500/50 μg b.i.d. in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.|26 weeks|FAS|||liters||Standard Error|Least Squares Mean
1357237|NCT01709864|Secondary|Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||liters||Standard Error|Least Squares Mean
1357238|NCT01709864|Secondary|Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Vital Capacity (FVC) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||liters||Standard Error|Least Squares Mean
1357239|NCT01709864|Secondary|Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||percentage of days||Standard Error|Least Squares Mean
1357240|NCT01709864|Secondary|The Average Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the mean daily number of puffs used per patient over the 12 weeks treatment period.|baseline and 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||number of puffs||Standard Error|Least Squares Mean
1357241|NCT01709864|Secondary|"Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||pecentage of days||Standard Error|Least Squares Mean
1357242|NCT01709864|Secondary|"Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours. The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||percentage of days||Standard Error|Least Squares Mean
1373986|NCT01521260|Secondary|Presence of Plaque||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1357244|NCT01709864|Secondary|Change From Baseline of Morning and Nighttime Symptom Scores at Week 12|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am & each pm.Each question can be answered w/1 of 4 pre-defined answers,with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of the symptom scores(either the score assessed in am for the previous 12 hrs-referred to as nighttime scores,or the score assessed in pm for the previous 12 hrs-referred to as the daytime symptom score) for each patient over 12 weeks.The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only and included all randomized patients who received at least one dose of study drug.|||score||Standard Error|Least Squares Mean
1357245|NCT01709864|Secondary|Change From Baseline of Daily Symptom Scores|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am and each pm. Each question can be answered w/1 of 4 pre-defined answers, with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of combined daily symptom scores(combined from am & pm)for each patient over 12 weeks. The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. Patients may have met the min. response requirements for the night scores(am questions),but not for the day scores(pm questions)or vice versa, the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||Score||Standard Error|Least Squares Mean
1357246|NCT01709864|Secondary|Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12|Breathlessness at week 12 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). Patients are considered to have clinically significant improvement with the TDI score change versus BDI being equal to or greater than 1. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||scores on a scale||Standard Error|Least Squares Mean
1357247|NCT01709864|Secondary|Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12|The health status, as reported by the patients, is assessed using the St. George’s Respiratory Questionnaire (SGRQ). The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically significant improvement in SGRQ is defined as less than or equal to -4 change from baseline.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||percentage of participants|||Number
1357248|NCT01709864|Secondary|Change From Baseline in the Health Status Assessed by St. George’s Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||score||Standard Error|Least Squares Mean
1357249|NCT01709864|Secondary|Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various time points post dosing on day 1 and at week 12 to calculate the AUC for these different time spans.|Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||liters*hr||Standard Error|Least Squares Mean
1357250|NCT01709864|Secondary|Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit|Trough Forced Expiratory Volume in one second (FEV1) is the mean of FEV1 at 23h 15min and 23h 45min after the morning dose of the previous day. Pre-dose trough FEV1 is the mean of FEV1 at -45min and -15min before morning dose|Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||liters||Standard Error|Least Squares Mean
1359865|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured 24 hours post-operative|24 hours post procedure|Only patients for whom 24-hour Troponin-I values were available were included in analysis|||ng/mL||Standard Deviation|Mean
1357251|NCT01709864|Primary|Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||liters*hr||Standard Error|Least Squares Mean
1357252|NCT01709799|Secondary|Timed Instrumental Activities of Daily Living Task|"The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
1357253|NCT01709799|Primary|Sweep Seeker Subtest of PositScience Insight|"Participants watch two patterns that “sweep” in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
1357254|NCT01709799|Primary|Road Tour Subtest of PositScience Insight|"Participants choose which car they saw at the center of the screen, and also locate where a Route 66 sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
1357255|NCT01709799|Primary|Master Gardener Subtest of PositScience Insight|"Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
1357256|NCT01709799|Primary|Jewel Diver Subtest of PositScience Insight|"Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
1357257|NCT01709799|Primary|Bird Safari Subtest of PositScience Insight|"Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
1357258|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement|"When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.~For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.||||grams per deciliter||95% Confidence Interval|Mean
1357259|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement|"Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.~For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.||||grams per deciliter||95% Confidence Interval|Mean
1357261|NCT01709708|Secondary|Headache Impact Test (HIT-6)|"Total Headache Impact Test (HIT-6) scores Pre-Treatment at Visit 2 vs. Post-Treatment (following final treatment), and at 1-Month Post-Treatment (Group A vs. Group B). HIT-6 is a series of 6 likert scale questions ranging from 1 to 5 with 1 being never and 5 being always. The HIT-6 answer options are weighted as follows: Never (1) = 6 points each, Rarely (2) = 9 points each, Sometimes (3) = 10 points each, Very often (4) = 11 points each, Always (5) = 13 points each. The total score for the HIT-6 ranges from 36 (subject answers all 6 questions as Never) to 78 subject answers all 6 questions as Always), with higher total scores indicating more impact than lower scores, i.e., headaches cause greater impact on the subject's life."|10 Weeks||||units on a scale||Standard Deviation|Mean
1357262|NCT01709708|Secondary|Adverse Events|Number of adverse events over the entire length of study (Group A vs. Group B).|34 weeks||||Number of Adverse Events||Standard Deviation|Mean
1357263|NCT01709708|Secondary|Acute Medications Usage|Number of acute medications used during Treatment period (6 weeks) and Follow-Up (4 weeks) (Group A vs. Group B).|10 Weeks||||Number of medications used||Standard Deviation|Mean
1357264|NCT01709708|Secondary|Migraine Headache Days|Compare change in the number of migraine headache days per month reported in Baseline Period Diary vs. Treatment Period Diary vs. Post-Treatment Period Diary.|12 Weeks||||Migraine headache days per month||Standard Deviation|Mean
1357265|NCT01709708|Secondary|Modified Pain Characteristic Questionnaire|Compare Modified Pain Characteristic Questionnaire scores Before Procedure vs. 24-Hour After Procedure, Before Procedure vs. 1-Month Follow Up, and Before Procedure vs. 6-Month Follow Up (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). The modified pain characteristic questionnaire is a series of 11 questions on a likert scale ranging from 0 to 10 with 0 being no pain or does not interfere and 10 being worst pain or completely interferes. Percentage questions range from 0 to 100.|Before Treatment, 24 Hours After Treatment, 1 Month Post Treatment, and 6 Months Post Treatment||||units on a scale||Standard Deviation|Mean
1357266|NCT01709708|Secondary|Patient's Global Impression of Change (PGIC)|Compare 24-Hour After Procedure Patient's Global Impression of Change (PGIC) score for 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). PGIC is a likert scale ranging from 1 to 7 with 1 being very much improved and 7 being very much worse.|30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks||||units on a scale||Standard Deviation|Mean
1357267|NCT01709708|Secondary|Change in Numeric Rating Scale (NRS)|Compare percentage change in Numeric Rating Scale (NRS) score from Before Procedure to 15-Minutes, Before Procedure to 30-Minutes, Before Procedure to 24-Hours After Procedure for all 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain.|15 Minutes Post Treatment, 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks||||percentage of change||Standard Deviation|Mean
1357268|NCT01709708|Primary|Numeric Rating Scale (NRS)|Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.|6 Weeks||||units on a scale||Standard Deviation|Mean
1357269|NCT01709695|Primary|Go/No-go Task Performance Correct Responses|Measures of go/no-go task performance during functional magnetic resonance imaging. Performance on a go-nogo task inside the scanner.|Baseline and 8 weeks||||percentage correct responses||Standard Deviation|Mean
1357270|NCT01709695|Secondary|Continuous Performance Test - Commissions|Neuropsychological assessment - Continuous Performance Test - Commissions. CPT is a task-oriented computerized assessment of attention-related problems. Scores are compared with the normative scores for the age, group and gender of the person being tested. A t-score of 50 is equal to the mean, with higher values indicating more problematic behaviors and lower scores indicating less problematic behaviors.|Baseline||||t-scores||Standard Deviation|Mean
1357271|NCT01709695|Secondary|Attention Deficit Hyperactivity Disorder Rating Scale IV (ADHDRS IV)|Norm referenced parent interview to assess severity and frequency of ADHD symptoms. Scores are reported as sums 0 (no symptoms) to 54 (severe).|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1357272|NCT01709695|Secondary|Digit Span|Neuropsychological assessment - Digit Span. The Digit Span test is either conducted verbally or using a computer program. A sequence of numbers is shown or read out to the participant. The participant is then told to repeat the numbers that were shown or read to them. This process continues until the participant can no longer remember either the full sequence of numbers or the correct order. This sequence is also continued until the participant makes an error. The Digit Span test is scored by the amount of numbers the participant was able to remember in each test. The scorer must add the total number of correct sequences, backwards and forwards. This test is also scored differently for a range of ages.|Baseline||||correct sequences||Standard Deviation|Mean
1357273|NCT01709695|Secondary|Finger Windows|Neuropsychological assessment: Finger Windows - a measure of spatial working memory. The participant shows memory of a demonstrated visual pattern. The examiner models a given sequence of windows and ask the participant to imitate the sequence by placing their finger through the same windows in the correct order. The total number of correct sequences achieved determines the level of performance.|Baseline||||correct sequences||Standard Deviation|Mean
1357274|NCT01709695|Secondary|Percentage Change in Atomoxetine Stimulant Side Effects Rating Scale (ASSERS)|Side effects rating scale. Assesses side effects known to occur in prior research using stimulant and non stimulant medications for treatment of ADHD. Scores range from 0 (not present) to 9 (severe side effects) and have been reported in aggregate as sum of severity responses on highest dose. This number is the sum of ASSERS, meaning it is the number and severity of side effects experienced. The percentage change in score from baseline.|up to 8 weeks||||percentage of mean effects improvement|||Number
1357275|NCT01709695|Secondary|Clinical Global Impressions (CGI-I)|Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse.)|up to 8 weeks||||units on a scale||Standard Deviation|Mean
1357276|NCT01709695|Primary|Go/No-go Task Reaction Time|Measures of go/no-go task performance during functional magnetic resonance imaging. Performance on a go-nogo task inside the scanner.|Baseline and 8 weeks||||ms||Standard Deviation|Mean
1357278|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - HAQ-DI at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. HAQ-DI consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with HAQ-DI assessment at both baseline and specified time points.|||units on a scale||Standard Error|Least Squares Mean
1357279|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - CRP Level at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. An elevated CRP level was considered a non-specific “marker” for RA. A reduction level indicates improvement. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with CRP assessment at both baseline and specified time points.|||mg/L||Standard Error|Least Squares Mean
1357280|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. Physician global VAS & participant global VAS was done by 100 mm non-anchored VAS, from no arthritis (0) activity to maximal arthritis (100) activity. Pain VAS by 100 mm VAS ranging from 0 “no pain” to 100 “worst pain”. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with individual ACR components assessment at both baseline and specified time points.|||mm||Standard Error|Least Squares Mean
1357281|NCT01709578|Secondary|Change From Baseline in Individual ACR Components - TJC and SJC at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with TJC and SJC assessments at both baseline and specified time points.|||joints||Standard Error|Least Squares Mean
1357282|NCT01709578|Secondary|Change From Baseline in RAID Scores at Week 12|RAID score is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well being, quality of sleep, and coping. The RAID is calculated based on 7 NRS questions. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicates worse status and lower indicates not affected. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID scores as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Mean
1357283|NCT01709578|Secondary|Change From Baseline in EQ-5D-3L VAS Scores at Week 12|The EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. The EQ-5D was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L scores as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
1357284|NCT01709578|Secondary|Change From Baseline in the FACIT-fatigue at Week 12|The FACIT-Fatigue is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.|Baseline, Week 12|ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
1357313|NCT01709578|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Week 24|ITT population.|||Percentage of participants|||Number
1357285|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
1357286|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Outside Help Hired Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
1357287|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Family/Social/Leisure Activities Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
1357288|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Household Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
1357289|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: House Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
1357290|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: RA Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
1357291|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
1357314|NCT01709578|Secondary|Percentage of Participants Achieving ACR70 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ-­DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|ITT population.|||Percentage of participants|||Number
1357292|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
1357293|NCT01709578|Secondary|Change From Baseline in SF-36 at Week 12|SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed=participants with SF-36 assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
1357294|NCT01709578|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-­CRP <2.6) at Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Week 12|ITT population.|||Percentage of participants|||Number
1357295|NCT01709578|Secondary|Change From Baseline in DAS28-CRP at Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS score as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with DAS28-CRP­ Score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
1357296|NCT01709578|Secondary|Percentage of Participants Achieving ACR20, ACR50 and ACR70 Criteria at Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ­-DI. ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR.|Week 12|ITT population.|||Percentage of participants|||Number
1357297|NCT01709578|Secondary|Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) VAS Scores at Week 24|The EQ-5D-3L is a standardized, generic measure of health outcome. It was designed for self-completion by participants. It was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L Scores as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357298|NCT01709578|Secondary|Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Scores at Week 24|RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicate worse status and lower indicate not affected. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357331|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
1357299|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357300|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
1357301|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
1357302|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
1357303|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
1357304|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357305|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
1357315|NCT01709578|Secondary|Percentage of Participants Achieving ACR50 Criteria at Week 24|ACR responses are assessed with a composite rating scale that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ-­DI. ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|ITT population.|||Percentage of participants|||Number
1357306|NCT01709578|Secondary|Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
1357307|NCT01709578|Secondary|Change From Baseline in Morning Stiffness VAS at Week 24|RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline Morning Stiffness as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with morning stiffness VAS assessment at both baseline and Week 24.|||mm||Standard Error|Least Squares Mean
1357308|NCT01709578|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Score at Week 24|The FACIT-Fatigue is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.|Baseline, Week 24|ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357309|NCT01709578|Secondary|Change From Baseline in SF-36 MCS at Week 24|SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 MCS as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=participants with SF-36 MCS assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357310|NCT01709578|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS had 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS had 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 by MMRM with treatment,region,number of previous anti TNFs,visit,and treatment-by-visit interaction as fixed effects and baseline SF-36 (PCS) as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 PCS assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357311|NCT01709578|Secondary|Change From Baseline in HAQ-DI at Week 24|Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357312|NCT01709578|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline CDAI as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=number of participants with CDAI assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357329|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
1357316|NCT01709578|Secondary|Change From Baseline in Disease Activity Score for 28 Joints ­C-Reactive Protein (DAS28-­CRP) Score at Week 24|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS28-CRP score as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with DAS28-­CRP Score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1357317|NCT01709578|Primary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. Least-squares (LS) means and standard errors (SE) at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
1357318|NCT01709578|Primary|Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant (C-reactive Protein levels [CRP]); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by (health assessment questionnaire disability index [HAQ-DI]). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|Intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1357319|NCT01709513|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 24 Versus Atorvastatin - Raw Data Description - Intent-To-Treat (ITT) Analysis||From Baseline up to Week 24|ITT population|||percent change||Standard Deviation|Mean
1357320|NCT01709513|Other Pre-specified|Percentage of Participants Who Experienced Skeletal Muscle-related Adverse Event (AE)|Skeletal muscle-related adverse events were a predefined category including myalgia, muscle spasms, muscular weakness, musculoskeletal stiffness and muscle fatigue. Events that developed during treatment emergent adverse events period (the time from the first double-blindstudy treatment [injection or capsules, whichever came first] up to the day of the last double-blind injection + 70 days ) are reported.|From Baseline up to Week 24|Safety population|||participants|||Number
1357321|NCT01709513|Secondary|Percent Change From Baseline in Apo A­-1 at Week 12 -­ ITT Analysis|Least squares (LS) means and standard errors (SE) taken from MMRM (mixed effect model with repeated measures) analysis.|From Baseline to Week 12|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1357322|NCT01709513|Secondary|Percent Change in Fasting Triglycerides From Baseline to Week 12 -­ ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Fasting Triglycerides ITT population.|||percent change||Standard Error|Mean
1357323|NCT01709513|Secondary|Percent Change in HDL-C From Baseline to Week 12 -­ ITT Analysis|Least-squares (LS) means and standard errors (SE) taken from MMRM (mixed-effect model with repeated measures) analysis|From Baseline to Week 12|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1357324|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 -­ ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Lipoprotein(a) ITT population.|||percent change||Standard Error|Mean
1357325|NCT01709513|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357326|NCT01709513|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population|||percent change||Standard Error|Mean
1357327|NCT01709513|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357328|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
1357332|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
1357333|NCT01709513|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1357334|NCT01709513|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1357335|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 12 -­ ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1357336|NCT01709513|Secondary|Percent Change From Baseline in Total Cholesterol (Total­-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357337|NCT01709513|Secondary|Percent Change From Baseline in Non­-HDL-C at Week 24 ­- On­-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1357338|NCT01709513|Secondary|Percent Change From Baseline in Non­-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 ­- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357339|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 24 -­ On-­Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.|||percent change||Standard Error|Least Squares Mean
1357340|NCT01709513|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 ­- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-­baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357341|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On­-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 12|mITT population.|||percent change||Standard Error|Least Squares Mean
1357342|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL­-C at Week 12 -­ ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Least Squares Mean
1357343|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-­Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1357344|NCT01709513|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-­To-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357345|NCT01709500|Secondary|Percent Change From Baseline in Apo A­1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1357752|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set|||symptom free days||90% Confidence Interval|Least Squares Mean
1357349|NCT01709500|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357350|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
1357351|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357352|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
1357353|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis|Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to Week 52|mITT population.|||percentage of participants|||Number
1357354|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.|||percentage of participants|||Number
1357355|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to week 52|mITT population.|||percentage of participants|||Number
1357356|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.|||percentage of participants|||Number
1357357|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off treatment (ITT analysis).|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1357358|NCT01709500|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment.|From Baseline to Week 52|Total-­C ITT population.|||percent change||Standard Error|Least Squares Mean
1357359|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1357360|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1357361|NCT01709500|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357362|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population|||percent change||Standard Error|Least Squares Mean
1357363|NCT01709500|Secondary|Percent Change From Baseline in Non-High ­Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357364|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on­treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population|||percent change||Standard Error|Least Squares Mean
1367143|NCT01600586|Secondary|Discharge Weight|Description: Growth measures.|day of hospital discharge (approximately 5-7 weeks)||||grams||Inter-Quartile Range|Median
1357365|NCT01709500|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357366|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1357367|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1357368|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1357369|NCT01709500|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent­-to­-Treat (ITT) Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least­ squares (LS) means and standard errors at Week 24 were obtained from a mixed ­effect model with repeated measures (MMRM) to account for missing data. All available post ­baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model.|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1357370|NCT01709474|Primary|Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3|Adverse event grading based on National Cancer Institute— Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0|Baseline to 18 Weeks|Intent-to-treat|||Percentage of Participants|||Number
1357371|NCT01709474|Primary|Change in Average IFN Module Expression Level|No mechanistic analyses were performed due to recruitment feasibility issues.|Baseline to Week 18|Data were not collected and therefore no analyses could be performed.||||||
1357372|NCT01709422|Primary|Procedure Related Time|(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.|participants will be followed for the duration of procedure, an expected average of 2.0 hours ]|Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).|||minutes||Standard Deviation|Mean
1357373|NCT01709422|Secondary|Cardiovascular Adverse Events.|(1) desaturation(oxygen saturation < 90 % at least 10 second ) (2) hypotension ( systolic blood pressure < 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate < 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation < 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.|participants will be followed for the duration of procedure, an expected average of 2.0 hours|Intention to treat population include participants who received sedative agents and underwent ERCP.|||Participants|||Number
1357374|NCT01709409|Secondary|Curosurf-01|7. Mortality prior to discharge|36 weeks GA|||||||
1357375|NCT01709409|Secondary|Curosurf-01|6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA|36 Weeks GA|||||||
1357376|NCT01709409|Secondary|Curosurf-01|5. Adverse events during or after administration of surfactant|36 weeks GA|||||||
1357377|NCT01709409|Secondary|Curosurf-01|4. Number of doses of surfactant received|36 weeks GA|||||||
1357378|NCT01709409|Secondary|Curosurf-01|3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement|36 weeks GA|||||||
1357379|NCT01709409|Secondary|Curosurf-01|2. Duration of first intubation (in hours/days)|36 weeks GA|||||||
1357380|NCT01709409|Secondary|To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups.|1. Extubation failure|36 weeks GA|||||||
1357381|NCT01709409|Primary|The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation|"rate on ventilator ≤40 per minute and~mean airway pressure ≤ 10 cm H20 and~fi02 ≤ 30%"|48 hours||||Participants|||Count of Participants
1357382|NCT01709383|Secondary|Motricity Index|An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
1372765|NCT01536093|Primary|Urinary Secretary IgA Concentration at 2 Weeks of Age||2 weeks of age||||ng per g creatinine||Standard Deviation|Mean
1357383|NCT01709383|Secondary|Reading Assessments|A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
1357384|NCT01709383|Secondary|Cognitive-Linguistic Quick Test (CLQT)|The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
1357385|NCT01709383|Secondary|Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)|"Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with as able as before the stroke written on the right side of the line and not at all as able on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates as able as before the stroke and 0 indicates not at all as able."|3 weeks post-treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
1357386|NCT01709383|Secondary|Philadelphia Naming Test (PNT)|A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.|1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
1357387|NCT01709383|Secondary|Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient|The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
1357388|NCT01709383|Primary|Western Aphasia Battery - Revised: Naming and Word Finding Score|This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.|Change from baseline to one day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
1357389|NCT01709331|Secondary|Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52|Semen samples were produced by masturbation after at least 48 hours of sexual abstinence and collected for evaluation in the pretreatment phase at Week -1, and during the combined treatment phase at Weeks 16, 28, 40, and 52.|Up to Week 52|FAS population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.|||Percentage of participants||95% Confidence Interval|Number
1357390|NCT01709331|Primary|Percentage of Participants With Anti-Corifollitropin Alfa Antibodies|Blood samples were collected for assessment of anti-corifollitropin alfa antibodies in the pretreatment phase at Week -16 and Week -1; during the combined treatment phase at Weeks 4, 16, 28, 50, 52; and at the post-treatment follow-up visit, which could occur from Week 53 up to Week 57.|Up to Week 57|All-Subjects-as-Treated (ASaT) population, which consisted of all participants who received any dose of corifollitropin alfa.|||Percentage of participants|||Number
1357391|NCT01709331|Primary|Change From Baseline in Log-Transformed Testicular Volume at Week 52|Participants underwent testicular ultrasound in the pretreatment phase at Weeks -16, -8, -1; and during the combined treatment phase at Baseline (predose, Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The testicular volume was measured as the sum of volumes of left and right testes. The mean change from Day 1 in log-transformed testicular volume was analyzed using a mixed model with a fixed effect for time point and a random effect for the participant. For each time point, the mean change from Day 1 to that time point and the associated 95% confidence interval (CI) was calculated. The geometric mean fold change in testicular volume and its 95% CI was obtained by exponentiation.|Baseline and Week 52|Full Analysis Set (FAS) population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.|||Fold change||95% Confidence Interval|Geometric Mean
1357392|NCT01709305|Secondary|Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)|"The percentage of participants with a GI AE of abdominal pain was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
1357393|NCT01709305|Secondary|Percentage of Participants With a GI AE of Diarrhea (Phase 2)|"The percentage of participants with a GI AE of diarrhea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
1357394|NCT01709305|Secondary|Percentage of Participants With a GI AE of Vomiting (Phase 2)|"The percentage of participants with a GI AE of vomiting was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
1357395|NCT01709305|Secondary|Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)|"The percentage of participants with a GI AE of nausea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
1357396|NCT01709305|Secondary|Percentage of Participants With Hypoglycemia Events (Phase 2)|Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
1357397|NCT01709305|Secondary|Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)|Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.|Phase 2 Baseline (Week 20), Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||kg||Standard Deviation|Mean
1357398|NCT01709305|Primary|Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)|HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.|Phase 2 Baseline (Week 20) and Week 44|Per-Protocol (PP) population - excluded those participants who were identified as protocol violators and those who were non-compliant with Good Clinical Practice (GCP) requirements.|||Percent||95% Confidence Interval|Least Squares Mean
1357399|NCT01709227|Secondary|Modified Oxygenation Index|Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen|at 24 and 48 hours postoperative||||Units||Inter-Quartile Range|Median
1357400|NCT01709227|Secondary|B-Natriuretic Peptide|BNP measured at 24 and 48 hours postoperatively|At 24hours and 48 hours postoperative||||pg/ml||Inter-Quartile Range|Mean
1357401|NCT01709227|Secondary|Doses of Potassium Chloride or Arginine Chloride Required|Total doses of potassium chloride or arginine chloride given during the first five postoperative days.|Postop day 0-5||||doses given||Inter-Quartile Range|Median
1357402|NCT01709227|Secondary|Renal/Electrolyte Abnormalities|Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol|Postop morning 1-5||||abnormalities||Inter-Quartile Range|Median
1357403|NCT01709227|Secondary|All Cause Mortality|In-hospital mortality|duration of hospitalization (an average of 2 weeks)||||Participants|||Count of Participants
1357404|NCT01709227|Secondary|Duration of Hospital Stay|Total days of initial postoperative stay in hospital|Average 4 weeks||||days||Inter-Quartile Range|Median
1357405|NCT01709227|Secondary|Duration of Cardiac ICU Stay|Total days of initial postoperative stay in cardiac ICU|Average 2 weeks||||days||Inter-Quartile Range|Median
1357406|NCT01709227|Secondary|NGAL Concentration||Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr)|Data were collected but not analyzed. Due to a high incidence of volatile and un-reportable NGAL levels, concerns were raised about the storage or processing of samples affecting data validity. Given the overwhelming concern of erroneous data, analysis was not performed as planned.||||||
1357407|NCT01709227|Secondary|Respiratory Support Administered|Duration of initial course of postoperative mechanical ventilation|Duration of postoperative intubation (average time approximately- 1 week)||||days||Inter-Quartile Range|Median
1357408|NCT01709227|Primary|Number of Participants With Negative Fluid Balance on Postop Day 1|Difference of inputs and outputs, including urine output and PD drainage.|Postop day 1||||Participants|||Count of Participants
1357409|NCT01709162|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 of treatment to 90 days after last dose (or to death date for death information)|All participants who received at least 1 dose of study drug|||Participants|||Number
1357422|NCT01709110|Secondary|Proportion of Participants With New Multiple (2 or More) Vertebral Fractures||Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
1359866|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured pre-operatively|pre-operatively|Only patients for whom preoperative Troponin-I values were available were included in analysis|||ng/mL||Standard Deviation|Mean
1357410|NCT01709162|Secondary|Best Overall Response Rate (BORR)|BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized||||||
1357411|NCT01709162|Secondary|Disease Control Rate (DCR)|DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized||||||
1357412|NCT01709162|Primary|Overall Survival|Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)|From randomization to death or last known alive date, assessed up to 15.6 months|All participants who were randomized|||Months||Full Range|Median
1357413|NCT01709136|Secondary|SRL Prevent TAC-related Side Effects|Whether SRL can prevent or minimize progression of selected TAC-related side-effects such as renal dysfunction as measured by clearance of iothalamate (Glomerular filtration rate < 80 mL/min/1.73 m2) and hypertension (blood pressure > 140/90 mm Hg)|1 year|Due to FDA blackbox warnings from FDA (6/11/2009) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.||||||
1357414|NCT01709136|Primary|Early and Late Pharmacokinetics of Sirolimus (SRL)|To evaluate early and late pharmacokinetics of Sirolimus (SRL) , and safety and efficacy of conversion from tacrolimus (TAC) to sirolimus in liver transplant recipients who have been stable for at least 3 months, and who have early nephrotoxicity and/or hypertension due to use of tacrolimus.|1 year|Three pharmacokinetics (PK) profiles were performed, one in each of three patients who were enrolled. However, due to FDA blackbox warnings (6/11/2009) about Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.||||||
1357415|NCT01709136|Secondary|SRL Can Substitute TAC|Whether Sirolimus can substitute Tacrolimus in the stable post-transplant state, without compromising allograft function|12 months|Due to FDA blackbox warnings (6/11/09) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early. Due to the early termination of this study and small number of subjects enrolled (3), data analysis was not able to be completed.||||||
1357416|NCT01709136|Secondary|PK Parameters for Tacrolimus and Sirolimus|pharmacokinetics (PK) of SRL after a single dose and after steady state has been achieved; and the pharmacokinetics of tacrolimus once at steady state|12 months|We were able to preform 3 pharmacokinetics (PK) profiles, one in each of three patients enrolled. However, due to emerging data and blackbox warnings from FDA suggesting that use of Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.||||||
1357417|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)|The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.|Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
1357418|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)|The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.|Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
1357419|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale|Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.|Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
1357420|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in Height||Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Centimeter (cm)||Standard Deviation|Mean
1357421|NCT01709110|Secondary|Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures|Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
1357490|NCT01708057|Secondary|Maximum Increase Heart Rate [HR]|Maximum (post-dose values – baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
1357423|NCT01709110|Secondary|Proportion of Participants With New Moderate and/or Severe Vertebral Fractures|Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).|Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
1357424|NCT01709110|Secondary|Proportion of Participants With Major Non-Vertebral Fragility Fractures|A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
1357425|NCT01709110|Secondary|Proportion of Participants With Non-Vertebral Fragility Fractures|A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
1357426|NCT01709110|Secondary|Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures|"A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.~All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader."|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
1357427|NCT01709110|Secondary|Proportion of Participants With Pooled New and Worsening Vertebral Fractures|Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).|Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
1357428|NCT01709110|Primary|Proportion of Participants With New Vertebral Fractures|"The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.~A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture."|Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
1357429|NCT01709084|Secondary|Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations|To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.|Up to Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.|||Participants|||Number
1357430|NCT01709084|Secondary|Percentage of Participant With Treatment Adherence Based on Tablet Count|In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively).|Up to 48 Weeks|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1357431|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1357432|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1357433|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48|Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.|||Percentage of Participants|||Number
1357434|NCT01709084|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus – Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48|Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.|||Percentage of Participants|||Number
1357435|NCT01708967|Primary|Success Rate of Transnasal Endoscopy|"We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.~We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity."|During transnasal endoscopy, up to 1 hours||||percentage of Participants||95% Confidence Interval|Number
1357436|NCT01708967|Other Pre-specified|Satisfaction|Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.|after transnasal endoscopy|||||||
1357437|NCT01708967|Secondary|Vital Signs|Blood pressure, heart rate, and O2 saturation were assessed.|before, during, and after transnasal endoscopy|||||||
1357438|NCT01708954|Secondary|Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher||Assessed every 4 weeks while on treatment and for 30 days after the end of treatment|All patients who received protocol therapy|||Proportion of participants||90% Confidence Interval|Number
1357439|NCT01708954|Secondary|Proportion of Patients With MET Positivity|Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women’s Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.|Assessed at baseline|Eligible and treated patients who had sufficient samples for MET expression analysis.|||proportion of participants||95% Confidence Interval|Number
1357440|NCT01708954|Secondary|Proportion of Patients With Objective Response|Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
1357441|NCT01708954|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1357442|NCT01708954|Primary|Progression-free Survival (PFS)|PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1357443|NCT01708915|Secondary|Patient Assessment of Efficacy on the Last Individual Treatment Day|Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application|1 to 4 days|Patients from FAS.|||participants|||Number
1357444|NCT01708915|Secondary|Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day|Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 1 to 4 days|Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day.|||units on a scale||Standard Error|Least Squares Mean
1357445|NCT01708915|Secondary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 4 hours after first ointment application|Patients from FAS.|||units on a scale||Standard Error|Least Squares Mean
1357446|NCT01708915|Primary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application|Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 8 hours after first ointment application|Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first application.|||units on a scale||Standard Error|Least Squares Mean
1357447|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.|From baseline until week 12|FAS|||percentage of participants||95% Confidence Interval|Number
1357491|NCT01708057|Secondary|Maximum Increase in Diastolic Blood Pressure [DBP]|Maximum (post-dose values – baseline value) for each treatment visit.|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
1357448|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group|"The frequency of patients with use of rescue therapy during 24 week treatment period in main group.~For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group."|From baseline until week 24|FAS|||percentage of participants||95% Confidence Interval|Number
1357449|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG|"The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.~Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 12|FAS (LOCF)|||mg/dL||Standard Error|Mean
1357450|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group|"The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.~Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 24|FAS (LOCF)|||mg/dL||Standard Error|Mean
1357451|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in APG|The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG|From baseline until week 12|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
1357452|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in Main Group|The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group|From baseline until week 24|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
1357453|NCT01708902|Primary|The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG|"The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)~The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 12|FAS (LOCF)|||percentage||Standard Error|Mean
1357454|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)|"The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.~The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.~The sensitivity analysis was added as the primary analysis failed with borderline results."|Baseline and week 24|FAS (OC): subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered|||percentage||Standard Error|Mean
1357455|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
1357456|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
1357457|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
1357458|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS - non-completers were considered as nonresponders (NCF)|||percentage of participants||95% Confidence Interval|Number
1357459|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group|"The change from baseline in HbA1c after 24 weeks of treatment in main group.~The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 24|Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.|||percentage||Standard Error|Mean
1357460|NCT01708525|Primary|Rate of Collagen Synthesis|Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.|4 weeks post-treatment||||percentage of new collagen synthesized|||Number
1357461|NCT01708317|Primary|Gonorrhea and Chlamydia Testing in the Pediatric ED|"The primary outcome was change in the proportion of adolescent patients receiving chlamydia and gonorrhea testing rates during their ED visit over 4 time periods.~Period 1) 2010 testing as a historical control Period 2) Jan 2011, began providing staff education about the risks of gonorrhea/chlamydia and need for increased testing Period 3) Education continues, but enrolled patients in the ACASI from April 18, 2011 - Dec 20, 2011.~Period 4) ACASI enrollment completed, education continued through March 2012~We specifically analyzed gonorrhea/chlamydia testing among ED patients that would have been eligible to take the ACASI, had it been continuously available throughout these time periods. We did this to isolate the effects on testing by the ACASI vs. education alone."|27 months|We analyzed every patient in this time period that met our ACASI inclusion/exclusion criteria|||percentage of participants|||Number
1357462|NCT01708291|Primary|Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)|Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in <5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score >= 7 indicates stress.|Baseline and week 10||||participants|||Number
1357492|NCT01708057|Secondary|Maximum Increase in Systolic Blood Pressure [SBP]|Maximum (post-dose values - baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
1357493|NCT01708057|Secondary|Average FEV1 as a Change From Baseline|Average FEV1 (0-24h): The average over 0 to 24 hours|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.||||||
1371946|NCT01545076|Secondary|Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period||Up to 25 weeks|ITTS|||Days||95% Confidence Interval|Median
1357463|NCT01708278|Primary|Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description|"Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function.~PULMONARY FUNCTION TEST:~FEV1% of predicted: decline by >20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : <2000, Platelets (cells)/mm3: <25,000, Hemoglobin (g/dL): <7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): <125 or >148, Potassium (mmol/L): < 3.0 or > 6.0, Calcium (mmol/L): <7.4 or > 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value >3X upper limit of normal"|One week in Phase I safety study||||Participants|||Count of Participants
1357464|NCT01708213|Secondary|Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS|This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.|6 months||||percentage of participants|||Number
1357465|NCT01708213|Secondary|Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds|"For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).~WSS:~(0) - No wrinkle~- Just perceptible wrinkle~- Shallow wrinkle~- Moderately deep wrinkle~- Deep wrinkle, well-defined edges~- Very deep wrinkle, redundant fold"|6 months|Wrinkle Severity Score (WSS) assessment values of the Nasolabial Folds treatment area for the Per Protocol population (N=10) is a subgroup of the N=43 per protocol subjects treated. Reporting on the subjects with a 1 point improvement on the WSS at 6 months time.|||participants|||Number
1357466|NCT01708213|Primary|Assessment of Treatment Site Responses Post Procedure|The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.|6 months||||percentage of participants with any AE|||Number
1357467|NCT01708187|Primary|Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months|"Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.~VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score"|Baseline,12 months||||units on a scale|||Number
1357468|NCT01708174|Secondary|Pharmacokinetics (PK): Summary of Plasma Trough Concentrations for Sonidegib (LDE225)|Blood samples were collected for assessment. The children's group was analyzed up until week 25 only.|Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49 and 53|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||ng/mL||Standard Deviation|Mean
1357469|NCT01708174|Secondary|Overall Survival (OS) From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|OS was defined as the time from date of randomization to date of death due to any cause. All deaths are considered, including deaths occurred after crossover for TMZ participants.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1357470|NCT01708174|Secondary|Duration of Response (DoR) According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|DoR was defined as the time from the first documented onset of confirmed PR or CR to the date of PD/relapse or death due to medulloblastoma. DoR was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma. TMZ participants without an event prior to crossover were censored.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1357471|NCT01708174|Secondary|Percentage of Participants With ORR According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). ORR was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma. Assessments after crossover were not included for TMZ patients.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1357472|NCT01708174|Secondary|PFS According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|PFS was defined as the time from date of randomization to the date of event defined as the first documented progression or death due to any cause. PFS was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The FAS was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1357473|NCT01708174|Secondary|Progression Free Survival (PFS) According to IRC From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|PFS was defined as the time from date of randomization to the date of event defined as the first documented progression or death due to any cause (as per tumor response guidelines and criteria for Medulloblastoma). The IRC evaluated all radiological images and applicable clinical data (i.e., neurological examination, steroid use and cerebrospinal fluid (CSF) results as applicable). TMZ participants without event prior to crossover were censored.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The FAS was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1378464|NCT01472874|Secondary|Cu Urine||Months 1,2,3,6,9,12 (mean)||||mcg/24hr||Standard Deviation|Mean
1357474|NCT01708174|Primary|Percentage of Participants With Overall Response Rate (ORR) According to Independent Review Committee (IRC) From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) (as per tumor response guidelines and criteria for Medulloblastoma). The IRC evaluated all radiological images and applicable clinical data (i.e., neurological examination, steroid use and cerebrospinal fluid (CSF) results as applicable). Assessments after crossover were not included for TMZ participants.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1357475|NCT01708161|Secondary|Tmax and T Half of AMG - Phase Ib|Tmax and half life of AMG 479 (ganitumab)|Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr||Full Range|Median
1357476|NCT01708161|Secondary|Area Under Curve (AUC) 0-336 Hour of AMG - Phase Ib|Area under curve for AMG 479 (ganitumab)|Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose)|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr*ng/mL||Standard Deviation|Mean
1357477|NCT01708161|Secondary|Cmax of AMG - Phase Ib|Serum concentration for AMG 479 (ganitumab)|Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||ng/mL||Standard Deviation|Mean
1357478|NCT01708161|Secondary|Tmax and T Half of BYL - Phase Ib|Tmax and half life of BYL719 (Alpelisib)|Cycle 1 Day 1, Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr||Full Range|Median
1357479|NCT01708161|Secondary|Area Under Curve (AUC) 0-24 Hour of BYL - Phase Ib|Area under curve for BYL719 (alpelisib)|Cycle 1 Day 1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose)|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr*ng/mL||Standard Deviation|Mean
1357480|NCT01708161|Secondary|Cmax of BYL - Phase Ib|Serum concentration for BYL719 (alpelisib)|Cycle 1 Day 1, Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||ng/mL||Standard Deviation|Mean
1357481|NCT01708161|Secondary|Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II|"the antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.~Phase II only, Cycle 1 Day 1 through Cycle 6 Day 28; assessed at baseline and every 8 weeks thereafter"|Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015)|Full analysis set|||Percentages of participants||95% Confidence Interval|Number
1357482|NCT01708161|Secondary|Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib|The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1|Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013)|Full Analysis set|||Percentages of participants||95% Confidence Interval|Number
1357483|NCT01708161|Secondary|Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib|The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1|Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013)|Full Analysis set|||Participants|||Number
1357484|NCT01708161|Primary|Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II|"The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.~Overall response rate is defined as the proportion of patients who have a best overall response of complete response or partial response assessed per RECIST 1.1."|Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015)|Full analysis set (FAS). The full analysis set (FAS) includes all patients who received at least one full or partial dose of alpelisib or ganitumab. Patients were analyzed according to the planned treatment combination.|||Percentages of participants||95% Confidence Interval|Number
1357485|NCT01708161|Primary|Dose Limiting Toxicities (DLTs) - Phase Ib|Phase lb only|28 days|Dose determining set (DDS): DDS includes all patients from the safety set who either met the minimum treatment exposure and safety evaluation requirements without experiencing DLT within Cycle 1 or experienced a DLT at any time during Cycle 1.|||Participants|||Number
1357486|NCT01708122|Secondary|O2 Saturation Post Drug Administration|After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.|Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.||||percentage of O2 Saturation||Full Range|Mean
1357487|NCT01708122|Primary|Pre Procedure 0 - 10 Pain Numerical Rating Scale|"The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:~1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed."|Pre procedure, During procedure, Post procedure||||0 - 10 Pain Numerical Rating Scale||Full Range|Median
1357488|NCT01708057|Secondary|PK Parameters (AZD8683)|Cmax, tmax, AUC|Pre-dose, 24hr post-dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
1357489|NCT01708057|Secondary|Maximum Increase in QTcF|maximum (post-dose values – baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
1360905|NCT01669434|Secondary|Postoperative Hypotension|Any systolic blood pressure less than 90 mmHg|Arrival in PACU to hospital discharge, an expected average of 4 days.||||Participants|||Count of Participants
1357496|NCT01707667|Secondary|Motility Index|Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||mmHg||Standard Error|Least Squares Mean
1357497|NCT01707667|Secondary|Duration of HAPC|The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||sec||Standard Error|Least Squares Mean
1357498|NCT01707667|Secondary|Propagation Velocity of HAPC|Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||cm/sec||Standard Error|Least Squares Mean
1357499|NCT01707667|Secondary|Time to First HAPC|The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.|over 12 hours post-dose|The Pharmacodynamic Analysis Set included all subjects in the Safety Analysis Set who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||hours||95% Confidence Interval|Median
1357500|NCT01707667|Secondary|The Mean Amplitude of HAPC|The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||mmHg||Standard Error|Least Squares Mean
1357501|NCT01707667|Secondary|Area Under the Concentration Curve (AUC) of All HAPCs|The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||mmHg.sec||Standard Error|Least Squares Mean
1357502|NCT01707667|Primary|The Number of High-Amplitude Propagating Contractions (HAPC)|Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||Number of HAPC with amplitude ≥100mmHg||Standard Error|Least Squares Mean
1357503|NCT01707654|Other Pre-specified|Pain|Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1–3 cm), moderate (4–6 cm) and severe (7–10 cm).|17–25 months|||||||
1357504|NCT01707654|Secondary|Semmes-Weinstein (SW) Monofilament Test|The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.|17–25 months|||||||
1357505|NCT01707654|Primary|2-point Discrimination Test|The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.|17-25 months||||mm||Standard Deviation|Mean
1357506|NCT01707290|Secondary|Number of Participants With Serious Adverse Events (SAEs) in Observational Arm|SAE was defined as a medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|up to 2 years (Study 112)|Analysis population included all participants who were included in the observational arm.|||participants|||Number
1357507|NCT01707290|Secondary|Number of Pulmonary Exacerbations Events|Pulmonary exacerbation events include those events which require treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Through Week 104 (Study 112)|FAS included all participants who received at least 1 dose of study drug (Ivacaftor).|||pulmonary exacerbation events|||Number
1357517|NCT01707238|Secondary|Comfort|Participant’s subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).|two weeks and four weeks from baseline visit||||units on a scale||Standard Deviation|Mean
1357753|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set|||Asthma symptom free days||90% Confidence Interval|Least Squares Mean
1357508|NCT01707290|Secondary|Absolute Change From Baseline in Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R) at Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104|The CFQ-R is a validated participant reported outcome measuring health related quality of life for participants with CF. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health related quality of life. Baseline was defined as the most recent measurement before intake of the first dose of study drug (ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (ivacaftor). Here, Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm respectively."|||units on a scale||Standard Deviation|Mean
1357509|NCT01707290|Secondary|Absolute Change From Baseline in Sweat Chloride at Week 2, 24, 48 and 104|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 24, 48 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number of participants analyzed signifies those participants who were evaluable for this outcome and Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm respectively."|||millimole per liter (mmol/L)||Standard Deviation|Mean
1357510|NCT01707290|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 2,12, 24, 36, 48, 60, 72, 84, 96 and 104|BMI was defined as weight in kg divided by height in m^2. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively."|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
1357511|NCT01707290|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 12, 24, 36, 48, 60, 72, 84, 96, and 104|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 6 to 17 years and for female participants aged 6 to 15 years. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively."|||Percent predicted of FEV1||Standard Deviation|Mean
1357512|NCT01707290|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) in Ivacaftor Arm|AE: any untoward medical occurrence in a participants during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. TEAEs were defined as adverse events with start date or increased severity on and after the first dose of study drug through Week 108.|Day 1 up to Week 108 (Study 112)|Safety Set included all participants who received at least 1 dose of study drug (Ivacaftor).|||participants|||Number
1357513|NCT01707238|Secondary|Satisfaction With Comfort|Participant’s subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit||||percentage of participants|||Number
1357514|NCT01707238|Secondary|Satisfaction With Dryness|Participant’s subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit||||percentage of participants|||Number
1357515|NCT01707238|Primary|Satisfaction With Handling|Participant’s subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit||||percentage of participants|||Number
1357516|NCT01707238|Secondary|Dryness|Participant’s subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).|two weeks and four weeks from baseline visit||||units on a scale||Standard Deviation|Mean
1357565|NCT01706666|Secondary|Survival Time|The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All patients are still alive|||Months to death|||Number
1357518|NCT01707238|Primary|Handling|Participant’s subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).|two weeks and four weeks from baseline visit||||units on a scale||Standard Deviation|Mean
1357519|NCT01707225|Secondary|Need for Blood Transfusion and Hospital Admission for GI Bleed||24 weeks||||participants||95% Confidence Interval|Number
1357520|NCT01707225|Primary|Number of Participants With Side-Effects|"Cardiovascular:~Sinus bradycardia (19% to 25%) Hypertension (≤13%) conduction abnormalities (9% to 10%)~Central nervous system:~Fatigue (1% to 32%) headache (6% to 30%) malaise (16% to 20%) fever (16% to 20%) dizziness (5% to 20%) Pain (4% to 15%)~Dermatologic:~Pruritus (≤18%) Rash (15%; depot formulation) alopecia (≤13%)~Endocrine & metabolic:~Hyperglycemia (2% to 27%)~Gastrointestinal:~Abdominal pain (5% to 61%) loose stools (5% to 61%) nausea (5% to 61%) diarrhea (34% to 58%) flatulence (≤38%) cholelithiasis (13% to 38%; length of therapy dependent) constipation (9% to 21%) vomiting (4% to 21%)~Hematologic Anemia (5-15%)~Local:~Injection site pain (2% to 50%; dose and formulation related)~Neuromuscular & skeletal:~Back pain (1% to 27%) arthropathy (8% to 19%) myalgia (≤18%)~Renal Kidney Stones (5-15%)~Respiratory:~Upper respiratory infection (10% to 23%)~Miscellaneous:~flu symptoms (1% to 20%)"|24 weeks||||participants||95% Confidence Interval|Number
1357521|NCT01707095|Secondary|Histologic Evidence of Burn at the Epigastric Port Site Skin.|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day||||participants|||Number
1357522|NCT01707095|Primary|Histologic Thermal Injury to Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.|1 day||||participants|||Number
1357523|NCT01707043|Primary|Subjective Subject Preference Survey for the Second Treatment Session|Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.|3 days||||units on a scale||Standard Deviation|Mean
1357524|NCT01707043|Primary|Subjective Subject Preference Survey for the First Treatment Session|Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.|3 days||||units on a scale||Standard Deviation|Mean
1357525|NCT01706965|Primary|Final MATRICS Cognitive Battery|MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.|Baseline to week 6||||Total MATRICS score||Standard Deviation|Mean
1357526|NCT01706965|Primary|Final Positive and Negative Symptom Scale (PANSS)|This is a is a 30 item rating scale widely used in the assessment of schizophrenia ranging from 30-210. Higher scores are worse|Baseline (start of Kuvan) and at six weeks of treatment||||PANSS Total||Standard Deviation|Mean
1357527|NCT01706952|Secondary|End Tidal CO2|"The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes.~For the secondary objective of concentration of carbon dioxide, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes or until 300 minutes||||Percentage of carbon dioxide||Standard Deviation|Mean
1357528|NCT01706952|Secondary|Blood Pressure|"The mean blood pressure, defined as the average arterial pressure during a single cardiac cycle, will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~For the secondary objective of blood pressure, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes or until 300 minutes||||mmHg||Standard Deviation|Mean
1357529|NCT01706952|Secondary|Heart Rate|"The heart rate (heart beats for minutes) will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~The Co-investigator will record this data in a special data sheeet For the secondary objective of Heart rate, we calculated the average within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes until 300 minutes||||Heart Beats per minute||Standard Deviation|Mean
1357530|NCT01706952|Primary|To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case).|"0 No bleeding.~Slight bleeding - no suctioning of blood required.~Slight bleeding - occasional suctioning required. Surgical field not threatened.~Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.~Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.~Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.~For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes until 300 minutes|EACH SIDE WAS EVALUATED SEPARATELY|||units on a scale||Standard Deviation|Mean
1357531|NCT01706926|Secondary|Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.|||percentage of participants|||Number
1372235|NCT01542502|Other Pre-specified|Inflammatory Biomarkers|Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.|28 days|||||||
1357532|NCT01706926|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each arm, respectively."|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1357533|NCT01706926|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169|FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1357534|NCT01706926|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357535|NCT01706926|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357536|NCT01706926|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357537|NCT01706926|Secondary|Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
1357538|NCT01706926|Secondary|Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169|CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
1357539|NCT01706926|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1357540|NCT01706926|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||cm||Standard Error|Mean
1357541|NCT01706926|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||mm||Standard Error|Mean
1378465|NCT01472874|Secondary|Cu Urine||Pre Treatment (mean)||||mcg/24hr||Standard Deviation|Mean
1357542|NCT01706926|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||mm||Standard Error|Mean
1357543|NCT01706926|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||joint count||Standard Error|Mean
1357544|NCT01706926|Secondary|Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357545|NCT01706926|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357546|NCT01706926|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Error|Mean
1357547|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357548|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357549|NCT01706926|Secondary|Oxygen Saturation Level at Day 169|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||percent saturation||Standard Deviation|Mean
1357550|NCT01706926|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1357551|NCT01706926|Secondary|Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15 percent (%), more than (>) 15 to =<20%, and >20%.|Day 169|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."|||percent of pulmonary test values|||Number
1357772|NCT01704495|Secondary|Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months||From start of treatment up to 6 months||||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
1357552|NCT01706926|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.|||participants|||Number
1357553|NCT01706926|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.|||participants|||Number
1357554|NCT01706926|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.|||percentage of participants|||Number
1357555|NCT01706926|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
1357556|NCT01706926|Primary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Baseline and Day 85|"The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1357557|NCT01706822|Secondary|Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate|Operatively||||% of cases surgeon agree/strongly agree|||Number
1357558|NCT01706822|Secondary|Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|2. Visibility measured by surgeon usability questionnaire|Operatively||||% of cases surgeon agree/strongly agree|||Number
1357559|NCT01706822|Secondary|Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|1. Access measured by surgeon usability questionnaire.|Operatively||||% of cases surgeon agree/strongly agree|||Number
1357560|NCT01706822|Primary|The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative||||participants|||Number
1357561|NCT01706822|Primary|The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The surgeon’s ability to achieve a staple line at the desired level of the rectum.|Operative||||participants|||Number
1357562|NCT01706770|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.~The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit."|Any occurrence from baseline to 1 month visit|Unique eyes are defined as each individual eye in the study.|||number of adverse events|Participants||Number
1357563|NCT01706770|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.~The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.|||units on a scale|Participants|Full Range|Mean
1357564|NCT01706666|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.|From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years||||Months to Progression|||Number
1357566|NCT01706666|Primary|Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months|Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.|24 months||||percentage of participants|||Number
1357567|NCT01706588|Secondary|Number of Patients With Adverse Events||from signature of the informed consent to 1 week postsurgery|||||||
1357568|NCT01706588|Secondary|Vital Signs||presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.|||||||
1357569|NCT01706588|Secondary|Recurrent Bleeding||every hour up to 6 hour postsurgery|||||||
1357570|NCT01706588|Secondary|Wound Healing||at 6 hour postsurgery, and on day 3 and 1 week postsurgery|||||||
1357571|NCT01706588|Secondary|Time to Onset of Pain||measured from end of surgery up to 12 hours postsurgery|||||||
1357572|NCT01706588|Secondary|Patient and Investigator Global Evaluation of the Effectiveness of Treatment||at 6 hour postsurgery and on Day 3|||||||
1357573|NCT01706588|Secondary|Rescue Medication Consumption||consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery|||||||
1357574|NCT01706588|Secondary|Amount of Rescue Medication||consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery|||||||
1357575|NCT01706588|Secondary|Time to First Use of Rescue Medication.||measured from end of surgery up to 1 week postsurgery|||||||
1357576|NCT01706588|Secondary|Peak Pain Intensity||measured from end of surgery up to 12 hours postsurgery|||||||
1357577|NCT01706588|Secondary|Trismus||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery|||||||
1357578|NCT01706588|Secondary|Postsurgical Extra-oral Swelling||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery|||||||
1357579|NCT01706588|Primary|Area Under the Curve (AUC) of the Pain Scores.|Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery||||mm*minutes||Standard Deviation|Mean
1357580|NCT01706575|Secondary|Safety: Percentage of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 48|Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.|||percentage of participants|||Number
1357581|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels||Baseline and Week 48|Data were not collected, and the outcome measure was not analyzed.||||||
1357582|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes||Baseline and Week 48|Data were not collected, and the outcome measure was not analyzed.||||||
1357583|NCT01706575|Secondary|Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96|HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.|Week 12 up to Week 96|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.|||participants|||Number
1357584|NCT01706575|Secondary|Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48||Baseline, Week 48|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.|||percentage of participants|||Number
1357585|NCT01706575|Secondary|Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96|Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.|Baseline, Week 24, 72 and 96|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure and n signifies the number of participants who were evaluated at specified time points.|||international units per millilitre||Standard Deviation|Mean
1357586|NCT01706575|Primary|Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)|Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.|Baseline and Week 48|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.|||percentage of participants|||Number
1357587|NCT01706575|Primary|Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)||Baseline up to Week 48|Per-Protocol Population (PP) included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.|||percent change||Standard Deviation|Mean
1357588|NCT01706549|Secondary|Is the Pain Due to Hysterectomy?|Number of patients having posthysterectomy pain versus other pain|1-3 years||||participants|||Number
1357589|NCT01706549|Secondary|Quality of Life After Hysterectomy|Quality of life as measured by the SF-36, which consists of 8 scales.|1-3 years after hysterectomy|||||||
1357590|NCT01706549|Primary|Type of Chronic Pain After Hysterectomy|Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.|1-3 years after hysterectomy|Women undergone hysterectomy previously and reported having pain at the site of surgery six months after surgery|||participants|||Number
1357591|NCT01706536|Secondary|The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||percentage of participants|||Number
1378466|NCT01472874|Primary|Cu Serum||Months 1,2,3,6,9,12 (mean)||||mcg/24h||Standard Deviation|Mean
1357592|NCT01706536|Secondary|The Percentage of Subjects With Treatment-emergent Serious Adverse Events|Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||percentage of participants|||Number
1357593|NCT01706536|Secondary|The Percentage of Subjects With Treatment-emergent Adverse Events|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||percentage of participants|||Number
1357594|NCT01706536|Secondary|The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||participants|||Number
1357595|NCT01706536|Secondary|The Number of Subjects With Treatment-emergent Serious Adverse Events|Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||participants|||Number
1357596|NCT01706536|Secondary|The Number of Subjects With Treatment-emergent Adverse Events|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||participants|||Number
1357597|NCT01706536|Secondary|The Peak FEV1 Change From Baseline|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.|Day 28|The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.|||liters||Standard Deviation|Mean
1357598|NCT01706536|Secondary|The Standardized Change From Baseline FEV1 AUC(12-24)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|Day 28|A substudy of subjects in the ITT population consisted of subjects who were randomized to treatment and received at least 1 dose of double-blind study medication and who had extended spirometry measurements.|||liters||Standard Deviation|Mean
1357599|NCT01706536|Secondary|The Standardized Change From Baseline FEV1 AUC(0-12)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|Day 28|The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.|||liters||Standard Deviation|Mean
1357600|NCT01706536|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).|Baseline and Day 29|The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.|||liters||Standard Deviation|Mean
1357601|NCT01706458|Other Pre-specified|The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively.|Not performed because no progression free survival at one year.|12 months|This outcome measure was not determined because there was no progression free survival at one-year.||||||
1357602|NCT01706458|Other Pre-specified|Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine.|Not performed because no progression free survival at one year.|12 months|This outcome measure was not determined because there was no progression-free survival at one-year.||||||
1357603|NCT01706458|Other Pre-specified|Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival.|Not performed because no progression free survival at one year.|12 months|This outcome measure was not determined because there was no progression free survival at one-year.||||||
1357604|NCT01706458|Other Pre-specified|PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine|A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency> 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.|12 months||||Participants|||Count of Participants
1357605|NCT01706458|Other Pre-specified|Number of Circulating Tumor Cells||6 months|This outcome measure was not determined because there was no progression free survival at one-year.||||||
1357606|NCT01706458|Other Pre-specified|Overall Survival|Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.|5 years|||||||
1357607|NCT01706458|Secondary|Measure Prostate-specific Antigen (PSA) Doubling Time|PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time “response”.|12 months||||months||95% Confidence Interval|Median
1357608|NCT01706458|Secondary|Time to Radiographic Disease Progression|Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.|12 months||||days||Full Range|Median
1357609|NCT01706458|Secondary|Progression-free Survival|Percentage of patients without radiographic progression at 12 months.|12 months||||Participants|||Count of Participants
1357610|NCT01706458|Primary|Number of Participants With Immune Response Following Treatment|The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.|12 months||||Participants|||Count of Participants
1357611|NCT01706328|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline trough was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 85|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1357612|NCT01706328|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1 during the 0- to 4-hour serial measurements (5, 15, 30, 60, 120, and 240 minutes post-dose). Participants who never met or exceeded a 100 mL increase over the Baseline value during the 4-hour serial measurements were censored at the actual time of their last FEV1 measurement.|Baseline and Day 1|ITT Population. Only those participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
1357613|NCT01706328|Primary|Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating the area under curve, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measurements on Day 84 minus the Baseline trough FEV1 value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study drug. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1357614|NCT01706263|Secondary|Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8|Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4, 8|Intent-to-treat analysis set.|||Score on scale||Standard Deviation|Mean
1357615|NCT01706263|Secondary|Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.|Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4, 8|Intent-to-treat analysis set.|||Score on scale||Standard Deviation|Mean
1357616|NCT01706263|Secondary|Percentage of Participants Who Improved by at Least One Grade on the ISGA|Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .|Up to Week 8|Intent-to-treat analysis set.|||Percentage of participants|||Number
1357617|NCT01706263|Secondary|Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8|Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4, 8|Intent-to-treat analysis set.|||Score on a scale||Standard Deviation|Mean
1357618|NCT01706263|Secondary|Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4|Evaluator assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4|Intent-to-treat analysis set.|||Percent change||Standard Deviation|Mean
1357773|NCT01704495|Primary|Rate of Severe Asthma Exacerbations During 6 Months||From start of treatment up to 6 months|Full analysis set|||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
1357619|NCT01706263|Primary|Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8|Evaluator assessed the left and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 8|Intent-to-treat analysis set was used which included data from all randomized participants who received study product.|||Percent change||Standard Deviation|Mean
1357620|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Scaling|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for scaling. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the scaling was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||units on scale||Standard Deviation|Mean
1357621|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Itching|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for itching. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the itching was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
1357622|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Burning|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for burning. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the burning was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1, 2, 4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1,2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
1357623|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Dryness|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for dryness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the dryness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population . Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
1357624|NCT01706250|Secondary|Mean Change in Each of the Participant Tolerability Assessments-Redness|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for redness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the redness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
1357625|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Peeling|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the peeling was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk (1, 4 and 8) and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points were analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
1357634|NCT01706159|Secondary|Clearance (CL) of rFXIII|The volume of plasma cleared of the drug per unit time.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose pharmakokinetics (PK) for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.||||||
1357626|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Dryness|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the dryness was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at baseline respectively. The change from BL was '0' for Wk 2, Wk 4, and Wk 8 and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||units on scale||Standard Deviation|Mean
1357627|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Erythema|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. Erythema is condition characterized by redness or rash on the skin. The assessment of the erythema was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk 4 and Wk 8, and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||units on scale||Standard Deviation|Mean
1357628|NCT01706250|Secondary|Mean Change in Investigator’s Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.|The evaluator (blinded) evaluated the acne severity of the participants' face using the ISGA scale ranging from 0 to 5. The grading was 0= Clear, skin with no IL or NILs; 1= Almost clear, rare NILs with no more than one small IL ; 2= Mild, some NILs with no more than few ILs (papules/pustules only, no nodular lesions); 3= Moderate Upto many NILs and may have some ILs but no more than one small nodular lesion ; 4= Severe, Upto many NILs and ILs but no more than a few nodular lesions; 5= Very severe, many NILS and ILs more than a few nodular lesions, may have cystic lesions. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
1357629|NCT01706250|Secondary|Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the total lesions by the sum of both inflammatory and non-inflammatory lesions on each side (left side and right side). The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of total lesions) at each individual visit (percent value at Wks 1, 2 and 4) minus the value at baseline respectively.|BL (Day 1) to Wks 1, 2 and 4|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||percent change in lesion count||Standard Deviation|Mean
1357630|NCT01706250|Secondary|Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the NIL by the presence of open and closed comedones. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of NIL) at each individual visit (percent value at Wk 1, 2 and 4) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2 and 4|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||percent change in lesion count||Standard Deviation|Mean
1357631|NCT01706250|Secondary|Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the IL by counting the number of papules and pustules. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of IL) at each individual visit (percent value at wk 1, 2 and 4) minus the value at BL respectively.|BL (Day1) to Wks 1, 2 and 4|ITT used. Only those participants available at the specified time points were analyzed (re presented by n=x, x in the category titles).|||percent change in lesion count||Standard Deviation|Mean
1357632|NCT01706250|Primary|Mean Percent Change in Inflammatory Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8.|This was an efficacy variable. An expert grader evaluated each side of the face (included forehead, cheeks and chin), the left and the right side, for IL (presence of papules and pustules), NIL (presence of open and closed comedones) and the TLs. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. The evaluator was also blinded. BL was defined as Day 1. The percent change was calculated as the value at Wk 8 minus the value at BL.|BL (Day 1) and Wk 8|The Intent to treat (ITT) analysis set included data from all randomized participants who received the study drug. The number of participants available at that particular time point were used for analysis.|||percent change in lesion count||Standard Deviation|Mean
1357633|NCT01706159|Secondary|Maximum Concentration (Cmax) of rFXIII|The peak plasma concentration of the drug after dose administration.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose PK for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.||||||
1360838|NCT01670045|Secondary|Percentage of Participants With Rheumatoid Factor Status|"Percentage of participants with rheumatoid factor status was reported as positive or negative."|Baseline up to Day 5|ITT.|||percentage of participants|||Number
1357636|NCT01706159|Secondary|Remission (Clinical and Endoscopic)|Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).|At Week 8|Full analysis set (FAS) included all randomised and treated subjects. Two subjects in the rFXIII group had no UC-DAI score at any visit, including baseline and they were excluded from the analysis.|||Subjects|||Number
1357637|NCT01706159|Primary|Endoscopic Remission Defined as a Modified Baron Score of 0|"The primary endpoint was the binary variable (responder vs. non-responder) where responders were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as “non-responders”."|At week 8|Full analysis set (FAS) included all randomised and treated subjects.|||Subjects|||Number
1357638|NCT01706146|Other Pre-specified|Stroke-free Survival Rate|To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
1357639|NCT01706146|Other Pre-specified|Major Bleeding-free Survival Rate|To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
1357640|NCT01706146|Other Pre-specified|Overall Survival|To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
1357641|NCT01706146|Other Pre-specified|Stroke Rate|To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
1357642|NCT01706146|Secondary|Bleeding Incidence|To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.|up to 12 months||||participants|||Number
1357643|NCT01706146|Primary|Number of Days on Anticoagulation|Assess subject anticoagulant utilization and number of days on anticoagulation|up to 12 months||||days||Standard Deviation|Mean
1357644|NCT01705717|Secondary|Percentage of Participants Who Died|Any cause of death (including non-liver disease related) was reported.|Diagnosis and End of Study, up to 36 months after diagnosis|All enrolled participants|||percentage of participants|||Number
1357645|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants|||percentage of participants|||Number
1357646|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Cirrhosis||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants|||percentage of participants|||Number
1357647|NCT01705717|Secondary|Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion|HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.|End of Study, up to 36 months after diagnosis.|All enrolled participants;|||percentage of participants|||Number
1357648|NCT01705717|Secondary|Percentage of Participants Who Were HCV Seronegative at the End of Treatment|End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.|End of Study, up to 36 months after diagnosis.|All enrolled participants|||percentage of participants|||Number
1357649|NCT01705717|Primary|Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy|SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.|6 months|All enrolled participants.|||percentage of participants|||Number
1357650|NCT01705652|Primary|PSA (Prostate Specific Antigen)|PSA decline to < 1.0 ng/ml at 3 months post end of radiation or surgery|3 months post end of radiation treatment or surgery|Radiation Group: One subject who did not complete the study was included as he did stay in the study through the 3 month post radiation treatment time period, and dropped out after that time.|||participants|||Number
1357651|NCT01705587|Secondary|Difference in Biochemical Markers of Bone Turnover|upfront therapy group compared to delayed therapy group and no therapy group|intervals over 12-18 months depending on treatment group|Funding unavailable for sample analysis.||||||
1357652|NCT01705587|Secondary|Quality of Life Improvements|Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.|at 12 months||||units on a scale||Standard Error|Mean
1357653|NCT01705587|Secondary|Increased Bone Density|Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck|at 6 and 12 months||||percentage change in BMD||Standard Error|Mean
1357654|NCT01705587|Secondary|Radiologic Healing||at 2, 6, 24, and 48 weeks|Data not collected at 2 and 6 weeks. Twenty-Four week (6 months) data is presented in 6 month outcomes, and 48 week (12 months) data as 12 month outcomes (See primary outcomes section above).||||||
1357655|NCT01705587|Primary|Radiologic Evidence of Healing|Number of participants with persistence of alignment as determined by a radiologist.|at 10 weeks for immediate teriparatide group|Based on orthopedic surgeons' assessment, x-rays were not deemed necessary in over 30% of patients at week 10. Results presented are for those who had x-rays at 10 weeks to assess persistence of alignment for safety purposes.|||Participants|||Count of Participants
1357656|NCT01705587|Primary|Radiologic Evidence of Bone Healing|The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.|6, 12 months of treatment||||units on a scale||Standard Error|Mean
1357657|NCT01705574|Secondary|Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase||Baseline; Open-Label Extension Week 48|||||||
1357659|NCT01705574|Secondary|Percentage of Participants Receiving Open-Label E/C/F/TDF With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open- Label Extension Phase|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Open-Label Extension Week 48|||||||
1357660|NCT01705574|Secondary|Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase||Baseline; Week 48|Participants in the ITT Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
1357661|NCT01705574|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Intent-to-treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
1357662|NCT01705496|Other Pre-specified|Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject’s infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.~The trial failed primary outcome, and this secondary outcome was not analyzed."|30 hours|||||||
1357663|NCT01705496|Other Pre-specified|Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.~The trial failed primary outcome, and this secondary outcome was not analyzed."|15 mins|||||||
1357664|NCT01705496|Other Pre-specified|Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards|"An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.~The trial failed primary outcome, and this secondary outcome was not analyzed."|30 +/- 2 days|||||||
1357665|NCT01705496|Secondary|Understand the Prevalence of Prosthetic Joint Infection|The trial failed primary outcome, and this secondary outcome was not analyzed|30 +/- 2 days|||||||
1357666|NCT01705496|Secondary|Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints|The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.|30 +/- 2 days|||||||
1357667|NCT01705496|Secondary|Evaluate the Safety and Tolerability of [124I]FIAU|Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.|30 +/- 2 days|22 received the investigational drug. A single IV injection of 5 mCi [124I]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.|||participants with adverse events|||Number
1357668|NCT01705496|Primary|Estimate the Sensitivity and Specificity of [124I]FIAU|"The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient’s infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.~Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used."|30 hours|Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.|||percentage of participants||80% Confidence Interval|Number
1357669|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI = (Weight [in kg]) divided by (Stature [in meters])^2. Data was reported as per the dose received and for overall participants.|Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
1357670|NCT01705145|Primary|Part A: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (hydroxymethyl ivacaftor [M1] and ivacaftor carboxylate [M6]) up to 24 hours post-dose on Day 4 (Hour 0 [pre-dose] on Day 1 and Day 4; 2, 3, 6, 24 hours post-dose on Day 4). Data was planned to be reported for overall participants in the period.|Part A: up to 24 hours post-dose on Day 4|Part A Safety set included all participants who received at least 1 dose of study drug in part A.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1357671|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Stature at Week 24|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||centimeters (cm)||Standard Deviation|Mean
1357672|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24|Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Deviation|Mean
1357774|NCT01704404|Other Pre-specified|Plasma Half-life|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.~Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7|The number of subjects reported for plasma half lives are based on the actual evaluable PK data.|||hours||Standard Deviation|Mean
1378467|NCT01472874|Primary|Cu Serum||Pre Treatment (mean)||||mcg/24h||Standard Deviation|Mean
1357673|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||Standard Deviation|Mean
1357674|NCT01705145|Secondary|Part B: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (M1 and M6) up to 24 hours post-dose on Day 168 (Hour 0 [predose] on Day 1, 14, 56, 112, and 168; 2, 3, 6 hours post-dose on Day 14; 1 hour post-dose on Day 56; 4, 6 hours post-dose on Day 112; 24 hours post-dose on Day 168). Data was planned to be reported for overall participants in the period.|Part B: up to 24 hours post-dose on Day 168|Part B Safety set included all participants who received at least 1 dose of study drug in part B.|||ng/mL||Standard Deviation|Mean
1357675|NCT01705145|Primary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. AE includes both serious and non-serious AE. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received."|Part B: Up to 28 Weeks|Part B Safety set included all participants who received at least 1 dose of study drug in part B.|||participants|||Number
1357676|NCT01705145|Primary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received and for overall participants."|Part A: Up to 93 Days|Part A Safety set included all participants who received at least 1 dose of study drug in part A.|||participants|||Number
1357677|NCT01705106|Secondary|PK Drug Interaction Model|NONMEM software will be used to develop a model describing the drug interaction between capecitabine and celecoxib using PK data collected during the first four weeks of the study.|4 weeks|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
1357678|NCT01705106|Secondary|Drug-related Toxicities|Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.|Up to six months|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
1357679|NCT01705106|Secondary|Response Rate|Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.|Up to 2 years|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
1357680|NCT01705106|Secondary|CYP2C9 Genotype|Polymorphisms *2 and *3 will be genotyped and analyzed for their impact on celecoxib AUC using analysis of variance (ANOVA), controlling for gender, age, and other covariates.|one week|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
1357681|NCT01705106|Primary|AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)|These parameters will be estimated for each subject under each treatment condition. The mean ratios (combination therapy/celecoxib monotherapy) will then be estimated together with 90% confidence intervals (CI).|Day 7 and 14 post treatment|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
1357682|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Left Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks||||Newton/seconds||Inter-Quartile Range|Median
1357683|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Right Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks||||Newton/seconds||Inter-Quartile Range|Median
1357684|NCT01704976|Secondary|Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks||||Newton||Inter-Quartile Range|Median
1357685|NCT01704976|Secondary|Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks||||Newton||Inter-Quartile Range|Median
1357686|NCT01704976|Primary|Physical Functional Performance|"Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living.~The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is “Poor performance”; SPPB 7-9 is “Intermediate performance; SPPB 10-12 is “High Performance”."|after 4 weeks||||units on a scale||Inter-Quartile Range|Median
1357687|NCT01704846|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||hour|Participants|Geometric Coefficient of Variation|Geometric Mean
1378468|NCT01472874|Secondary|Albumin||Months 1,2,3,6,9,12 (mean)||||g/dL||Standard Deviation|Mean
1357688|NCT01704846|Secondary|Terminal Half-life (t1/2)|Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||hours|Participants|Geometric Coefficient of Variation|Geometric Mean
1357689|NCT01704846|Secondary|Terminal Rate Constant (λz)|Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||1/h|Participants|Geometric Coefficient of Variation|Geometric Mean
1357690|NCT01704846|Secondary|Time From Dosing to the Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum measured concentration of the analyte in plasma.~Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||hours|Participants|Standard Deviation|Mean
1357691|NCT01704846|Secondary|Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.~Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||ng*h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
1357692|NCT01704846|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
1357693|NCT01704846|Primary|Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.~Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||ng·h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
1357694|NCT01704781|Secondary|Part A and B: Safety and Tolerability||Part A: 31 days and Part B: 26 weeks||||participants|||Number
1357695|NCT01704781|Secondary|Part B: Incidents of Delayed-type Hypersensitivity|Delayed-type hypersensitivity measured by induration and erythema.|26 weeks|The IIT population was used for this outcome measure. Data for one patient was not reported at week 26.|||Participants|||Count of Participants
1357696|NCT01704781|Secondary|Part B: Evaluate the Effect on HIV Viral Load|Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while ‘not detected’ results have been replaced with 0 HIV copies/mL.|26 weeks|ITT analysis set|||Copies/mL||Standard Deviation|Mean
1357697|NCT01704781|Secondary|Part B: Change in CD8 Count|Change in CD8 count from baseline to week 26.|26 weeks|Not all patients had quantifiable blood samples/counts at all time points|||10^6 cells/L||Standard Deviation|Mean
1357698|NCT01704781|Primary|Part B: Change in CD4 Count|Change in CD4 count from baseline to Week 26.|Week 26|Analysis was performed for both the Intent To Treat (ITT) and Per Protocol (PP) analysis set.|||10^6 cells/L||Standard Deviation|Mean
1357699|NCT01704781|Primary|Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time||31 days|ITT analysis set was used.|||10^6 cells/mL||Standard Deviation|Mean
1357700|NCT01704781|Primary|Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity|Number of participants in each of the three groups that experienced any dose-limiting toxicity.|31 days|ITT analysis set was used.|||Participants|||Count of Participants
1357701|NCT01704755|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||Percentage of participants||95% Confidence Interval|Number
1357702|NCT01704755|Secondary|Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1357775|NCT01704404|Other Pre-specified|Tmax|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.~Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7||||hours||Standard Deviation|Mean
1357703|NCT01704755|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm|A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1357704|NCT01704755|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1357705|NCT01704651|Secondary|Postoperative Ileus Incidence|Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.|Patients will be followed for 30 days postop|Intent to treat analysis|||participants|||Number
1357706|NCT01704651|Primary|Postoperative Length of Hospital Stay|Length of stay = date/time of hospital dismissal - date/time of end of surgery|Patients will be followed for the duration of their hospital stay, an expected average of 5 days|Intent to Treat analysis|||days||Standard Deviation|Mean
1357707|NCT01704599|Post-Hoc|EKG Categoryy Changes Related to Homocysteine Changes|Change in EKG ( normalize, unchanged, became abnormal) when homocysteine (Hcy) increased or decreased from week 16 on adalimumab to week 28 on adalimumab plus folic acid, vitamins B6 and B12 in adault psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.|Week 16 to Week 28|8 adults with moderate to severe plaque psoriasis ages 18-65. 4 were studied. Four were not because homocysteine levels at both Week16 nd 28 were not drawn(1 of the 4 had SAE prior to Week 16).|||participants|||Number
1357708|NCT01704599|Post-Hoc|Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.|Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28|Week 16 to Week 28 and Week 28 to post study day 70|8 Adults ages 18-65 with moderate tosevere plaque psoriasis. 7 subjects studied. The 8th had SAE prior to Week 16.|||participants|||Number
1357709|NCT01704599|Post-Hoc|PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF|Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis ages 18 to 65. Seven were analyzed. The one not analyzed had SAE prior to week16.|||participants|||Number
1357710|NCT01704599|Post-Hoc|PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3|Change in PASI from Week 16 on adalimumab to Week 28 on adalimumab, folic acid, vitamin B6 and B12 in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 Adult subjects ages 18-65 with moderate to severe plaque psoriasis. 7 had PASI data both Week 16 and Week 28. The 1 who did not had SAE prior to Week 16.|||participants|||Number
1357711|NCT01704599|Primary|Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change|PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28.|Weeks 16 and 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had PASI measured at weeks 16 and 28. One had SAE prior to week 16.|||participants|||Number
1357712|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasign and Decreasing Body Weight|Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study.|Week 16 and Week 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had weights taken weeks 0,4,16 and 28 allowing week16 and 28 analysis. One had weight taken only at weeks 0 and 4.|||participants|||Number
1357713|NCT01704599|Other Pre-specified|Number of Participants Who Fulfilled the Category of Having Height Measured|Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis.|Week 0 at Start of Adalimumab|8 Adults with mild to moderate plaque psoriasis had their height measured at week 0 in inches.|||participants|||Number
1357714|NCT01704599|Other Pre-specified|Number of Participants Within Categories of Body Temperature Change|Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Weeks 16 and 28|8 Subjects. Five had temperatures measured weeks 16 and 28. Three did not (one of the 3 had SAE prior to week16)|||participants|||Number
1357715|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:|Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12.|Week 16 and Week 28|of 8 adults with moderate to severe plaque psoriasis, Seven participants were measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. One who had SAE prior to Week 16 did not..|||participants|||Number
1357716|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)|Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study.|At screening|Only 1 of the 8 subjects was a woman of childbearing years during the study.|||participant|||Number
1378469|NCT01472874|Secondary|Albumin||Pre Treatment (mean)||||g/dL||Standard Deviation|Mean
1357717|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody|Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study.|Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins|8 adult participants with moderate to severe plaque psoriasis with H. pylori titers measured during the 28 week study.|||participants|||Number
1357718|NCT01704599|Secondary|Number of Participants With Category Change in Serum Folic Acid Level.|Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|Weeks 16 and 28|8 particpantts with psoriasis. Five had folic acid levels drawn weeks 16 and 28. Three did not (one of the 3 had a SAE prior to week 16).|||participants|||Number
1357719|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level|Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis.|At Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. .Four of 8 had levels drawn at weeks 16 and 28. Four did not. Of the four whoi did not one had a SAE prior to Week 16.|||participants|||Number
1357720|NCT01704599|Secondary|Number of Participants With Category Change in Vitamin B12 Blood Level|Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|At Week 16 and Week 28|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Five of 8 had B12 measured at weeks 16 and 28. Three did not. One of the 3 had SAE prior to week 16.|||participants|||Number
1357721|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine|Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis..|Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis. 4 had levels measured at Week 16 and again at Week 28. Of the 4 not meausres 1 had a SAE prior to Week16.|||participants|||Number
1357722|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus|Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Week 16 then Week 28|8 adults 18-65 years having moderate to severe plaque psoriasis. Five had levels measured at week 16 and and again at week 28 . Three did not . Of the 3 1 had SAE prior to week 16.|||participants|||Number
1357723|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium|Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis.|Weeks 16 and 28|8 Adults age 18-65 with moderate to severe plaque psoriasis.Five had results both weeks 16 and 28. Three did npot (of these 1 had SAE prior to week 16)|||participants|||Number
1357724|NCT01704599|Other Pre-specified|Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)|Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. Five had CBCs at both week 16 and week 28. three did not ( one of the 3 had a SAE pripor to week 16)|||participants|||Number
1357725|NCT01704599|Secondary|Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)|Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high|At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination|8 adult subjects age 18-65 with moderate to sefver plaque psoriasis. Five subjects had VEGF levels taken weeks 16 and 28. Three ( one wiht SAE prior to week 16) did not.|||participants|||Number
1357726|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)|An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study.|Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination|8 adults with moderate to severe plaque psoriasis. Seven evaluated at weeks 0,16 and 28 for no change in electrocardiogram (EKG) , worsening arrhymia or improvement of arrhythmia at weeks 16 and 28. Five of 8 studied weeks 0,16 and 28; 1 at week 16 and 28. Two (one with the SAE prior to Week 16) did not have EKGs both at weeks 16 and 28.|||participants|||Number
1357727|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)|A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28.|By Week 16, by Week 28 and by Day 70 post Week 28.|Adults ages 18-65 with moderate to severe plaque psoriasis.|||participants|||Number
1357776|NCT01704404|Other Pre-specified|Cmax|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.~Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7||||ng/mL||Standard Deviation|Mean
1357728|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and Not Having an Adverse Event|"Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study:~AE Humira only"|After Week 16 of study|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Seven assessed after week 16 and at Week 28 of study and assessed at day 70 post week 28 visit ( the latter by telephone). One subject had SAE prior to vitamin addition.|||participants|||Number
1357729|NCT01704599|Secondary|Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change|DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12).|Week 16 and Week 28|8 adults with moderate to severe plaque psoriasis measured at weeks 16 and 28. Seven were measured weeks 16 and 28. One had SAE prior to week 16.|||participants|||Number
1357730|NCT01704599|Secondary|Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):|Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. 7 had static PGA scores weeks 16 and 28 and one had sPGA but SAE prior to week 16.|||participants|||Number
1357731|NCT01704521|Primary|Number of Participants With Sustained Virological Response at Week 12 (SVR12)|"Viral kinetic assessment using SVR 12 to either lead-in 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment."|Post-treatment at week 12|See baseline characteristics|||participants|||Number
1357732|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at 1 Month||at 1 month|PK analysis set|||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1357733|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at Day 7||Day 7|PK analysis set|||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1357734|NCT01704495|Secondary|Number of Uncontrolled Persistent Asthma Weeks During Treatment||Day 1 to end of the 6 months treatment period|Full analysis set|||uncontrolled persistent asthma weeks||Standard Deviation|Mean
1357735|NCT01704495|Secondary|Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline||Last 2 weeks before randomization|Full analysis set|||participants|||Number
1357736|NCT01704495|Secondary|Number of Well Controlled Asthma Weeks During Treatment||Day 1to end of the 6 months treatment period|Full Analysis set|||well controlled asthma weeks||Standard Deviation|Mean
1357737|NCT01704495|Secondary|Number of Participants With Well Controlled Asthma Weeks at Baseline||Last 2 weeks before randomization||||participants|||Number
1357738|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
1357739|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)|full analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
1357740|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)|Full Analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
1357741|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
1357742|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)|Full Analysis set|||rescue medication free days||90% Confidence Interval|Least Squares Mean
1357743|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)||||rescue medication free days||90% Confidence Interval|Least Squares Mean
1357744|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set|||rescue medication free days||90% Confidence Interval|Least Squares Mean
1357745|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set|||rescue medication free days||90% Confidence Interval|Least Squares Mean
1357746|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
1357747|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
1357748|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
1357777|NCT01704404|Primary|Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)||From baseline to day 7||||FEV1 (mL)||Standard Error|Mean
1357754|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||Participants with improvement|||Number
1357755|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0), Treatment Period (1,3, and 6 months)||||Overall Score||90% Confidence Interval|Least Squares Mean
1357756|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||Participants with improvement|||Number
1357757|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)|Full Analysis set|||Units on a scale]||90% Confidence Interval|Least Squares Mean
1357758|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
1357759|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
1357760|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
1357761|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
1357762|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
1357763|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0||||L||90% Confidence Interval|Least Squares Mean
1357764|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
1357765|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
1357766|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
1357767|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
1357768|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0||||L||95% Confidence Interval|Least Squares Mean
1357769|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
1357770|NCT01704495|Secondary|Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms||From start of treatment up to 6 months|Full analysis set|||Days||90% Confidence Interval|Least Squares Mean
1357771|NCT01704495|Secondary|Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions||From start of treatment up to 6 months|Full analysis set|||Days||90% Confidence Interval|Least Squares Mean
1379245|NCT01464359|Secondary|Transplant-Related Mortality||Day 180 after Transplantation||||Participants|||Count of Participants
1357778|NCT01704287|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to approximately 33 months|The Safety Population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1357779|NCT01704287|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to approximately 36 months|The Safety Population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1357780|NCT01704287|Secondary|Duration of Response (DOR)|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. DOR was not analyzed for the crossover populations.|Up to approximately 33 months|Among participants who demonstrated a confirmed response (CR or PR), the population consisted of all randomized participants who had measurable disease at baseline and who demonstrated a confirmed CR or PR per RECIST 1.1. Participants were included in the treatment group to which they were randomized for the efficacy analysis.|||Months||Full Range|Median
1357781|NCT01704287|Secondary|Best Overall Response Among Participants Receiving ICC Who Switched to Receiving Pembrolizumab|The best overall response was assessed by independent radiology review using RECIST 1.1 and was recorded from the start of the second line of study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Best overall response was based based on independent review committee (IRC) for the crossover populations.|Up to approximately 29 months|The ITT Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the treatment group to which they were randomized for the efficacy analysis.|||Percentage of Participants|||Number
1357782|NCT01704287|Secondary|Best Overall Response - Initial Treatment Period|The best overall response was assessed by independent radiology review using RECIST 1.1 and was recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Best overall response for the Initial Treatment Period was based on IRO.|Up to approximately 33 months|The ITT Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Percentage of Participants|||Number
1357783|NCT01704287|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was not analyzed for the crossover populations.|Up to approximately 33 months|The ITT Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the treatment group to which they were randomized for the efficacy analysis.|||Months||95% Confidence Interval|Median
1357784|NCT01704287|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. PFS analysis was based on an integrated radiology and oncology (IRO) assessment. PFS was not analyzed for the crossover populations.|Up to approximately 33 months|The Intent-to-Treat (ITT) Population consisted of all randomized participants who had measurable disease at baseline. Participants were included in the treatment group to which they were randomized for the efficacy analysis.|||Months||95% Confidence Interval|Median
1357785|NCT01704261|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24.|24 weeks|The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.|||Percentage of participants||95% Confidence Interval|Number
1357786|NCT01704261|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1357814|NCT01703845|Primary|CLR,t1-t2,ss (Olodaterol)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1357787|NCT01704261|Primary|Percentage of Participants Who Discontinued From the Study Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 24|The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.|||Percentage of participants|||Number
1357788|NCT01704261|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 27|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.|||Percentage of participants|||Number
1357789|NCT01704261|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.|||%A1C||95% Confidence Interval|Least Squares Mean
1357790|NCT01704196|Secondary|Reduction in Use (Weeks 1 - 11)|Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11|Baseline through week 11||||participants|||Number
1357791|NCT01704196|Primary|Abstinence (Weeks 10 - 11)|Number of subjects that abstained from cocaine from weeks 10 through 11|Weeks 10 - 11||||Participants|||Count of Participants
1357792|NCT01704079|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol|||participants|||Number
1357793|NCT01704079|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat|||participants|||Number
1357794|NCT01704079|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders|Approximately 6 months|Per protocol|||participants|||Number
1357795|NCT01704079|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders|Approximately 6 months|Intent to treat|||participants|||Number
1357796|NCT01703988|Secondary|Urine Pharmacokinetics: Renal Clearance, Cohort 4|Renal clearance of nusinersen for participants was assessed in the 12 mg reporting group only, per protocol.|Day 1 and Day 85|Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data|||mL/hr||Standard Deviation|Mean
1357797|NCT01703988|Secondary|Cerebrospinal Fluid (CSF) Pharmacokinetics: Predose CSF Drug Concentrations||Day 1, Day 29, and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point. (This study includes participants previously enrolled in Study ISIS 396443 - CS1 (NCT01494701).|||ng/mL||Standard Deviation|Mean
1357798|NCT01703988|Secondary|Plasma Pharmacokinetics: Plasma Pharmacokinetics: Area Under the Plasma Concentration Time Curve From the Time of the IT Dose to 6 Hours After Dosing (AUC0-6hr)||Day 1 and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.|||ng*hr/mL||Standard Deviation|Mean
1357799|NCT01703988|Secondary|Plasma Pharmacokinetics: Time to Reach Cmax in Plasma||Day 1 and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.|||hours||Full Range|Median
1357800|NCT01703988|Secondary|Plasma Pharmacokinetics: Maximal Observed Plasma Drug Concentration (Cmax)||Day 1 and Day 85|Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.|||ng/mL||Standard Deviation|Mean
1357801|NCT01703988|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs|An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of the investigational drug product, whether or not the AE is considered related to the investigational drug product. An SAE is any AE that, in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; and is an important medical event in the judgment of the investigator. Drug-related is an event related or possibly related to study drug. Severity of AEs was assessed as mild, moderate, or severe.|Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days|Safety Population, defined as all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1357815|NCT01703845|Primary|fe t1-t2,ss (Olodaterol)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
1357802|NCT01703858|Secondary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1357803|NCT01703858|Primary|Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)|Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1357804|NCT01703858|Primary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
1357805|NCT01703845|Secondary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG|"Outcome data show are the number of participants with clinically relevant abnormalities reported as an adverse event (AE) related to the vital signs (pulse rate and blood pressure in supine position), clinical laboratory (routine blood chemistry, haematology, and urinalysis) tests and ECG (12-lead holter monitoring Electrocardiography). Relevant findings or worsening of baseline conditions were reported as adverse events.~There were no clinically relevant abnormalities reported as an AE related to the vital signs and ECG."|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|The treated Set (TS).|||participants|||Number
1357806|NCT01703845|Primary|CLR,t1-t2,ss (Tiotropium)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.~Plasma concentration of tiotropium could not be quantified up to 4 hours for Tiotropium + Olodaterol (2.5μg/5μg)."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1357807|NCT01703845|Primary|fe t1-t2,ss (Tiotropium)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
1357808|NCT01703845|Primary|Aet1-t2,ss (Tiotropium)|"Amount of tiotropium that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
1357809|NCT01703845|Primary|Tmax,ss (Tiotropium)|"Time from dosing to the maximum concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||h||Full Range|Median
1357810|NCT01703845|Primary|AUC0-tz,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1357811|NCT01703845|Primary|AUCt1-t2,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 2 hours at steady state (AUCt1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1 and 2 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1357812|NCT01703845|Primary|Cmax,ss (Tiotropium)|"Maximum measured concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.|||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1357813|NCT01703845|Secondary|Number of Participants With Adverse Events (Including Assessment Based on Physical Examination)|Outcome data show are the number of patients with an adverse event including the assessment based on physical examination.|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|Treated Set (TS) includes all randomised patients who received at least one dose of trial medication.|||participants|||Number
1358195|NCT01700816|Secondary|Average Dose of Antipsychotic Medications Required to Manage Delirium||From admission to hospital to discharge, an expected average of 28 days post-transplant|Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.||||||
1357816|NCT01703845|Primary|Aet1-t2,ss (Olodaterol)|"Amount of olodaterol that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
1357817|NCT01703845|Primary|Tmax,ss (Olodaterol)|"Time from dosing to the maximum concentration of Olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3 and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.|||h||Full Range|Median
1357818|NCT01703845|Primary|AUC0-tz,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1357819|NCT01703845|Primary|AUCt1-t2,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (AUCt1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1357820|NCT01703845|Primary|Cmax,ss (Olodaterol)|"Maximum measured concentration of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set was defined as all treated patients who have at least 1 PK parameter in the treatment period without PK related important protocol violations. Two patients prematurely stopped the trial medication and had no PK measurement at Visit 3 (day 21) and were excluded from the PK set. Thus, the PK set included 30 patients.|||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1357821|NCT01703832|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: “How much do you currently suffer from” (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
1357822|NCT01703832|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
1357823|NCT01703832|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||beats per minute||Full Range|Median
1357824|NCT01703832|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mmHg||Full Range|Median
1357825|NCT01703832|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 12 participants randomized to Natural Course could be evaluated for NK cells|||percentage of lymphocytes||Full Range|Median
1357826|NCT01703832|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Norepinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
1357827|NCT01703832|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Epinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
1357828|NCT01703832|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For the plasma Cortisol evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient sample.|||nmol/L||Full Range|Median
1357829|NCT01703832|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 to Natural Course and all randomized participants were included in the Safety Set. For plasma ACTH evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient samples and the -60 min time-point had 30 evaluable Neurexan participants.|||ng/L||Full Range|Median
1357830|NCT01703832|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||nmol/mL||Full Range|Median
1357831|NCT01703832|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minute, +15 minute , + 45 minute, +100 minute|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for efficacy. Note: -60 minute time-point had 31 evaluable Neurexan participants.|||IU/mL||Full Range|Median
1357832|NCT01703832|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
1357833|NCT01703832|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
1357843|NCT01703819|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||nmol/mL||Full Range|Median
1357876|NCT01703260|Primary|Percent Change From Baseline in Serum ALT at Month 4|The percent change between the serum ALT value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.|||percent change||Standard Deviation|Mean
1357834|NCT01703819|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: “How much do you currently suffer from” (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
1357835|NCT01703819|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before the stress test and were repeated at 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
1357836|NCT01703819|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||beats per minute||Full Range|Median
1357837|NCT01703819|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mmHg||Full Range|Median
1357838|NCT01703819|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 16 participants randomized to Placebo could be evaluated for NK cells.|||percentage of lymphocytes||Full Range|Median
1357839|NCT01703819|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Norepinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
1357840|NCT01703819|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Epinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
1357841|NCT01703819|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Cortisol, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.|||nmol/L||Full Range|Median
1357842|NCT01703819|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma ACTH, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
1360906|NCT01669434|Secondary|Postoperative Hypertension|Any systolic blood pressure greater than 180 mmHg.|Arrival in PACU to hospital discharge, an expected average of 4 days.||||Participants|||Count of Participants
1357844|NCT01703819|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol, alpha amylase, Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||IU/mL||Full Range|Median
1357845|NCT01703819|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0~= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
1357846|NCT01703819|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0~= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
1357847|NCT01703741|Secondary|Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng/dL||Standard Deviation|Mean
1357848|NCT01703741|Secondary|Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng/dL||Standard Deviation|Mean
1357849|NCT01703741|Secondary|Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng/dL||Standard Deviation|Mean
1357850|NCT01703741|Secondary|Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||hour||Full Range|Median
1357851|NCT01703741|Secondary|Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng*hr/dL||Standard Deviation|Mean
1357852|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL|The data were presented using descriptive statistics.|At Month 6|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
1357853|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL|The data were presented using descriptive statistics.|At Month 3|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
1357862|NCT01703702|Secondary|Change in Patient Management: Advice/Counseling|Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||percentage of patients|||Number
1357854|NCT01703741|Secondary|Domain Scores for the Short Form-12 (SF-12) Questionnaire|"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:~PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)~MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)~The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0–100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available SF-12 questionnaire results.|||units on a scale||Standard Deviation|Mean
1357855|NCT01703741|Secondary|Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire|"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).~The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available MAF questionnaire results.|||units on a scale||Standard Deviation|Mean
1357856|NCT01703741|Secondary|Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire|"In ADAM questionnaire, subjects had to respond in yes or no to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer (yes) to questions 1 or 7, or to any 3 other questions.~The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available ADAM questionnaire results.|||percentage of subjects|||Number
1357857|NCT01703741|Secondary|Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire|"Data collected from the five domains of sexual functions were summarized by descriptive statistics.~The domains are:~Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain."|At Month 6|ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available IIEF questionnaire results.|||units on a scale||Standard Deviation|Mean
1357858|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.|"Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
1357859|NCT01703741|Primary|Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL|"Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
1357860|NCT01703702|Secondary|Change in Patient Management: Individual Categories|Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer’s/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||percentage of patients|||Number
1357861|NCT01703702|Secondary|Change in Caregiver Self-efficacy|Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers’ self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||units on a scale||Standard Error|Least Squares Mean
1357877|NCT01703260|Primary|Amount of Serum Alanine Transaminase (ALT) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.|||international units per liter (IU/L)||Standard Deviation|Mean
1357863|NCT01703702|Secondary|Change in Diagnostic Confidence|Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.|||Percentage Point||Standard Error|Least Squares Mean
1357864|NCT01703702|Secondary|Change in Patient's Clinical Diagnosis|Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was not predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.|||percentage of patients|||Number
1357865|NCT01703702|Primary|Change in ADAS-Cog 11 Total Score|Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 12 months|Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value.|||units on a scale||Standard Error|Least Squares Mean
1357866|NCT01703702|Primary|Clinical and Diagnostic Change in Patient Management|Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||percentage of patients|||Number
1357867|NCT01703663|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.|night 1 and night 2||||apneas plus hypopneas per hour||Inter-Quartile Range|Median
1357868|NCT01703286|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events|up to 20 weeks|Treated set (TS)|||participants|||Number
1357869|NCT01703286|Secondary|Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28|Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.|||percentage||90% Confidence Interval|Mean
1357870|NCT01703286|Secondary|Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28|Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm||||Percentage||90% Confidence Interval|Geometric Mean
1357871|NCT01703286|Primary|Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28|Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.|||percentage||90% Confidence Interval|Geometric Mean
1357872|NCT01703260|Secondary|Change From Baseline in Liver Fat Content at Month 4|Liver fat content was quantitatively measured by evaluating the percentage of PDFF from an abdominal MRI. On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline and Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.|||percent change in PDFF||Standard Deviation|Mean
1357873|NCT01703260|Secondary|Liver Fat Content at Baseline|Liver fat content was quantitatively measured by evaluating the percentage of proton density fat fraction (PDFF) from an abdominal magnetic resonance imaging (MRI). On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.|||percentage of PDFF||Standard Deviation|Mean
1357874|NCT01703260|Secondary|Percent Change From Baseline in Serum AST at Month 4|The percent change between the serum AST value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.|||percent change||Standard Deviation|Mean
1357875|NCT01703260|Secondary|Amount of Serum Aspartate Transaminase (AST) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.|||IU/L||Standard Deviation|Mean
1357878|NCT01703221|Secondary|Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.|||mg/dL||95% Confidence Interval|Least Squares Mean
1357879|NCT01703221|Secondary|Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.|||mg/dL||95% Confidence Interval|Least Squares Mean
1357880|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.|||Percentage of participants|||Number
1357881|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug.|||Percentage of participants|||Number
1357882|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.|||Percentage of Participants|||Number
1357883|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During Phase A|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.|||Percentage of participants|||Number
1357884|NCT01703221|Primary|Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).|Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
1357885|NCT01703208|Other Pre-specified|Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)|Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants′ follow-up time to event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 Person-years|||Number
1357886|NCT01703208|Other Pre-specified|Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)|Participants with adjudicated and confirmed events of first hospitalization for heart failure.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants|||Number
1357887|NCT01703208|Secondary|Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.|18 weeks|The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.|||Percentage of participants||95% Confidence Interval|Number
1357888|NCT01703208|Secondary|Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.|Baseline and Week 18|The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1357889|NCT01703208|Secondary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 212 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication.|||Percentage of participants|||Number
1379246|NCT01464359|Secondary|Incidence of Acute Graft-Versus-Host Disease||Day 60||||Participants|||Count of Participants
1357890|NCT01703208|Secondary|Percentage of Participants Who Experienced at Least One Adverse Event|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 234 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication.|||Percentage of participants|||Number
1357891|NCT01703208|Secondary|Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline|Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.|Up to 179 weeks|Data for this efficacy endpoint was not collected, analyzed or summarized.||||||
1357892|NCT01703208|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months|This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.|Baseline and 4 months|Data for this efficacy endpoint was not collected, analyzed or summarized.||||||
1357893|NCT01703208|Secondary|Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).|4 months|Data for this efficacy endpoint was not collected, analyzed or summarized.||||||
1357894|NCT01703208|Secondary|Change From Baseline in A1C at Week 142|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.|Baseline and Week 142|The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
1357895|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death|All-cause death was death for any cause. Person-years were calculated as the sum of all participants′ follow-up time to event.|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication.|||Participants/100 Person-years|||Number
1357896|NCT01703208|Secondary|Number of Participants With an Event of All-Cause Death|All-cause death was death from any cause.|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded trial medication.|||Participants|||Number
1357897|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants′ follow-up time to event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 person-years|||Number
1357898|NCT01703208|Secondary|Number of Participants With an Event of Stroke (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants|||Number
1357899|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants′ follow-up time to first event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 person-years|||Number
1357900|NCT01703208|Secondary|Number of Participants With an Event of First MI (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants|||Number
1357901|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of CV-Related Death|Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants′ follow-up time to event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 person-years|||Number
1357902|NCT01703208|Secondary|Number of Participants With an Event of CV-Related Death|Participants with adjudicated and confirmed AEs of cardiovascular-related death.|Up to 179 weeks|The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.|||Participants|||Number
1357903|NCT01703208|Primary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 18|The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.|||Percentage of participants|||Number
1357904|NCT01703208|Primary|Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 18|The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.|||Percentage of participants|||Number
1357905|NCT01703208|Primary|Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.|Baseline and Week 18|The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||Percentage||95% Confidence Interval|Least Squares Mean
1359178|NCT01688050|Primary|Aortic Injury-related Mortality|Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.|30 days||||participants|||Number
1357906|NCT01703208|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 18|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.|Baseline and Week 18|The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
1357907|NCT01703208|Primary|Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)|Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants′ follow-up time to first event.|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded trial medication.|||Participants/100 Person-years|||Number
1357908|NCT01703208|Primary|Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)|Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded trial medication.|||Participants|||Number
1357909|NCT01703208|Primary|Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)|Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.|Up to 156 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.|||Participants|||Number
1357910|NCT01703169|Secondary|Characterization of the PK Profile of Eltrombopag in Patients With Moderate to Very Severe Aplastic Anemia. Evaluated With AUC, Cmax, Cmin, Tmax.|Samples will for PK analysis will collected as a trough level weeks 2, 6 and 12, prior to dose of eltrombopag. Additional PK level drawn at 2, 4 and 6 hours post-dose at the scheduled week 2 visit.|Weeks 2, 6 and 12|Data was not collected for this outcome variable.||||||
1357911|NCT01703169|Secondary|Number of Patients With AE to Measure Toxicity, Using NCI CTCAE|Evaluated weekly, up to 12 weeks. Association between eltrombopag use, dose, and tolerability in patients with moderate to very severe aplastic anemia|12 weeks|Data was not collected for this outcome variable.||||||
1357912|NCT01703169|Secondary|Hematology Labs|Association between eltrombopag use and response in hemoglobin, hematocrit, total white blood cell count, and absolute neutrophil count to be evaluate by maximal hemoglobin, hematocrit, total white blood cell count, and absolute neutrophil counts achieved in patients with moderate to very severe aplastic anemia|12 weeks|Data was not collected for this outcome variable.||||||
1357913|NCT01703169|Secondary|Platelet Count Twice Baseline.|Proportion of subjects who achieve platelet counts at least twice their baseline value at any point while on study medication, in patients with moderate to very severe aplastic anemia.|Between weeks 1-12.|Data was not collected for this outcome variable.||||||
1357914|NCT01703169|Primary|Proportion of Participants With Platelet Response|Defined as a stable platelet count of 50,000/μl or more during any 4 week period within the possible 12 weeks while on study,and including maximal platelet counts achieved in patients with moderate to very severe aplastic anemia.|up to 12 weeks||||proportion of participants||95% Confidence Interval|Number
1357915|NCT01703091|Secondary|Change From Baseline in Lung Cancer Symptom Scale (LCSS)|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Millimeter||Standard Deviation|Mean
1357916|NCT01703091|Secondary|Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score|The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Units on a Scale||Standard Deviation|Mean
1357931|NCT01703000|Secondary|In-segment Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).~The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm|Participants|Standard Deviation|Mean
1357932|NCT01703000|Secondary|In-stent Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.~The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm|Participants|Standard Deviation|Mean
1359179|NCT01688050|Primary|All-cause Mortality||30 days|One death was adjudicated as unrelated by the Clinical Events Committee (CEC).|||participants|||Number
1357917|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Percentage of Participants||95% Confidence Interval|Number
1357918|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Percentage of Participants||95% Confidence Interval|Number
1357919|NCT01703091|Secondary|Overall Survival (OS)|OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Baseline to Death from Any Cause (Up to 28 Months)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 36 and 35, respectively.|||Months||95% Confidence Interval|Median
1357920|NCT01703091|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow‑up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)|Full Analysis Set (FAS) population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 13 and 9, respectively.|||Months||95% Confidence Interval|Median
1357921|NCT01703000|Secondary|Longitudinal Stent Deformation|Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of stents|||Number
1357922|NCT01703000|Secondary|Percent Net Volume Obstruction|The percentage of volume obstruction, as measured by the IVUS core lab.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||% of volume|Participants|Standard Deviation|Mean
1357923|NCT01703000|Secondary|Incomplete Apposition|"Incomplete apposition rate, as measured by the IVUS core lab.~Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS)."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of lesions|Participants||Number
1357924|NCT01703000|Secondary|Lumen Volume|As measured by IVUS, the volume of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^3|Participants|Standard Deviation|Mean
1357925|NCT01703000|Secondary|Stent Volume|As measured by IVUS, the volume of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^3|Participants|Standard Deviation|Mean
1357926|NCT01703000|Secondary|Vessel Volume|As measured by IVUS, the volume of the vessel.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^3|Participants|Standard Deviation|Mean
1357927|NCT01703000|Secondary|Lumen Area|As measured by IVUS, the area of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^2|Participants|Standard Deviation|Mean
1357928|NCT01703000|Secondary|Stent Area|As measured by IVUS, the area of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^2|Participants|Standard Deviation|Mean
1357929|NCT01703000|Secondary|Vessel Area|As measured by IVUS, the mean vessel area (mm2).|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^2|Participants|Standard Deviation|Mean
1357930|NCT01703000|Secondary|Acute Gain|Acute gain, as measured by angiographic core lab|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm||Standard Deviation|Mean
1382496|NCT01436500|Secondary|Safety: Day 28 Mortality||28 days||||percentage of participants|||Number
1357933|NCT01703000|Secondary|In-segment Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).~Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||Diameter Stenosis, In-Segment (%)|Participants|Standard Deviation|Mean
1357934|NCT01703000|Secondary|In-stent Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.~Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||In-Stent % Diameter Stenosis|Participants|Standard Deviation|Mean
1357935|NCT01703000|Secondary|Clinical Procedural Success Rate|"Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of participants||95% Confidence Interval|Number
1357936|NCT01703000|Secondary|Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)|"Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.~Timing:~Acute stent thrombosis*: 0 24 hours after stent implantation~Subacute stent thrombosis*: >24 hours to 30 days after stent implantation~Late stent thrombosis: >30 days to 1 year after stent implantation~Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.~Stent thrombosis may be defined as:~Confirmed/definite~Probable~Possible~Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357937|NCT01703000|Secondary|All Death/MI/TVR Rate|"Any event meeting the pre-specified criteria for any death, MI, or TVR.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357938|NCT01703000|Secondary|All Death or MI Rate|"Any all-cause mortality event or MI meeting the criteria defined for any death or MI.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357939|NCT01703000|Secondary|Cardiac Death or MI Rate|"Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357940|NCT01703000|Secondary|All Death Rate|Death is categorized as cardiac or non-cardiac deaths.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357941|NCT01703000|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as a death not due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~CVA through hospital discharge or CVA suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357942|NCT01703000|Secondary|Cardiac Death Rate|"Cardiac death is defined as death due to any of the following.~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~CVA through hospital discharge or CVA suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357943|NCT01703000|Secondary|Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate|MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357944|NCT01703000|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.~The MI definition used was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357945|NCT01703000|Secondary|Target Vessel Revascularization (TVR) Rate|"Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:~The subject has a positive functional study corresponding to the area served by the target vessel.~The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.~The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1372236|NCT01542502|Other Pre-specified|Adverse Events|Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.|28 days|||||||
1357946|NCT01703000|Secondary|Target Lesion Failure (TLF) Rate|"Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non–Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.~The MI definition used for Target Lesion Failure was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357947|NCT01703000|Secondary|Target Lesion Revascularization (TLR) Rate|"Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:~The subject has a positive functional study corresponding to the area served by the target lesion.~The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.~The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
1357948|NCT01703000|Primary|Technical Success Rate|Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of lesions|Participants|95% Confidence Interval|Number
1357949|NCT01702987|Primary|Phosphocreatine Recovery|Percentage change in phosphocreatine recovery from baseline to month as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity|1 month||||percentage change from baseline||Standard Error|Mean
1357950|NCT01702961|Secondary|Number of Participants With Overall Best Response Achieved After Transplantation|Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.|3 months post-transplant|Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin’s disease.|||participants|||Number
1357951|NCT01702961|Secondary|Median Days to Neutrophil Engraftment|Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.|30 days post-transplant|All of the participants enrolled in the study engrafted.|||days||Full Range|Median
1357952|NCT01702961|Primary|Disease-free Survival|Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin’s lymphomas|12 months post-transplant||||percentage of participant||95% Confidence Interval|Number
1357953|NCT01702909|Secondary|Median Survival|from time of study entry until death|measured from date of first dose until date of death|There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.||||||
1357954|NCT01702909|Secondary|Median Duration of Response|Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Measured from first response until Disease Progression or death from any cause up to 2 years|There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.||||||
1357955|NCT01702909|Primary|Number of Participants With Response Using RECIST Criteria|Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).|Measured until Disease Progression or death from any cause up to 2 year|No data was collected||||||
1357956|NCT01702896|Secondary|Median Survival|Measured from date of entry on study until date of death|From time of study entry until death, up to 10 years|Data was not collected||||||
1357957|NCT01702896|Secondary|Median Duration of Response|Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Measured until Disease Progression or death from any cause up to 2 years|Data not collected||||||
1358012|NCT01702428|Secondary|Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups|Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||µg/mL||95% Confidence Interval|Geometric Mean
1357958|NCT01702896|Primary|Response Rate|Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).|Measured until Disease Progression or death from any cause up to 2 years|Data not collected||||||
1357959|NCT01702532|Secondary|The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes|Participants completed a cigarette craving assessment consisting of the following five items: “I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .|Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes||||mm||95% Confidence Interval|Least Squares Mean
1357960|NCT01702532|Primary|The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds|Participants completed a cigarette craving assessment consisting of the following five items: “I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.|Pre-dosing post-provocation to 50 seconds|All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.|||mm||Inter-Quartile Range|Least Squares Mean
1357961|NCT01702519|Secondary|Rate of Elimination (Kel)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Elimination rate constant for nicotine was determined from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Elimination rate constant for nicotine was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the study medications, had no protocol violations, and whose data was considered evaluable by the pharmacokineticist.|||1/hr||Full Range|Median
1357962|NCT01702519|Secondary|Plasma Half-life (t1/2)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. The elimination half-life of nicotine was determined by from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Plasma half-life (t1/2) was based on the baseline adjusted nicotine plasma concentration data|Baseline to 32 hours|Per-prorocol population, which included all randomized participants who received at least one dose of the study treatment, had no protocol violation, and whose data was considered evaluable by the pharmacokineticist.|||Hrs||Full Range|Median
1357963|NCT01702519|Secondary|Time to Maximum Plasma Concentration (Tmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Time to Maximum Plasma Concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points; immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application of the patch. Patch was then removed after the collection of 24 hour blood sample. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the drug, did not have any protocol deviations and whose data was considered evaluable by the pharmacokineticist.|||hrs||Full Range|Median
1357964|NCT01702519|Secondary|Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Area under the plasma nicotine concentration time curve from zero extrapolated to infinity was determined by plasma concentration time profile of nicotine. Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -inf) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.|||ng*h/mL||Standard Deviation|Mean
1357965|NCT01702519|Primary|Maximum Measured Plasma Concentration (Cmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.|||ng/mL||Standard Deviation|Mean
1358118|NCT01701401|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug|SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1357966|NCT01702519|Primary|Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant’s upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.|||nanogram (ng)*hour (hr)/milliliter (mL)||Standard Deviation|Mean
1357967|NCT01702454|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1357968|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 28 days (Days 0-27) after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1357969|NCT01702454|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.|During the entire study period (Days 0 - 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1357970|NCT01702454|Secondary|Number of Subjects Reporting AEs With Medically Attended Visits (MAV)|MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.|During the entire study period (Day 0 – Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1357971|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature > 39.0°C.|During the 7 days (Days 0 – 6) post dose 1 vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Subjects|||Number
1357972|NCT01702454|Secondary|Duration of Solicted Symptoms|Duration was defined as number of days with any grade of solicted local and/or general symptoms|During the 7-day (Days 0-6) post-vaccination Dose 1 period|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1357973|NCT01702454|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|During a 7-day (Day 0 to 6) follow-up period after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Subjects|||Number
1357974|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available|||Fold Increase||95% Confidence Interval|Geometric Mean
1358119|NCT01701401|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1357975|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1357976|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.|||Fold Increase||95% Confidence Interval|Geometric Mean
1357977|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were perfomed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available|||Subjects|||Number
1357978|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata|Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 0 and Day 7|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1357979|NCT01702454|Secondary|Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.|Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available|||Titers||95% Confidence Interval|Geometric Mean
1357980|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Fold increase||95% Confidence Interval|Geometric Mean
1357981|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
1358013|NCT01702428|Secondary|Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
1357982|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Fold Increase||95% Confidence Interval|Geometric Mean
1357983|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
1357984|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Titer||95% Confidence Interval|Geometric Mean
1357985|NCT01702454|Secondary|Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Titer||95% Confidence Interval|Geometric Mean
1357986|NCT01702454|Secondary|Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
1357987|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1357988|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1357989|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1357990|NCT01702454|Secondary|Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1357991|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
1357992|NCT01702454|Secondary|Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
1357993|NCT01702454|Secondary|Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1357994|NCT01702454|Primary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
1357995|NCT01702454|Primary|Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Fold Increase||95% Confidence Interval|Geometric Mean
1357996|NCT01702454|Primary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
1357997|NCT01702454|Primary|Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine|Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
1357998|NCT01702454|Primary|Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Titers||95% Confidence Interval|Geometric Mean
1357999|NCT01702454|Primary|Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1392828|NCT01331005|Primary|Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3||From Baseline to 12 months||||mm3||95% Confidence Interval|Mean
1358000|NCT01702454|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1358001|NCT01702454|Primary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1358002|NCT01702454|Primary|Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1358003|NCT01702454|Primary|Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
1358004|NCT01702428|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.|From Day 0 through the end of study (Day 180)|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1358005|NCT01702428|Secondary|Number of Subjects Reporting AEs of Specific Interest|AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.|From Day 0 through the end of study (Day 180)|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1358006|NCT01702428|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1358007|NCT01702428|Secondary|Number of Subjects Reporting Any MMR Specific Solicited AEs|Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1358008|NCT01702428|Secondary|Number of Subjects Reporting Any Rash|Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1358009|NCT01702428|Secondary|Number of Subjects Reporting Any Fever|Any fever = Fever ≥ 38°C.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1358010|NCT01702428|Secondary|Number of Subjects With Any Solicited General AEs|Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 15-days (Days 0-14) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1358011|NCT01702428|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 4-days (Days 0-3) post-vaccination period|Total Vaccinated cohort (TVC) included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
1373639|NCT01525407|Secondary|Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy||First 100 days after transplant||||Participants|||Count of Participants
1358014|NCT01702428|Secondary|Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups|Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358015|NCT01702428|Secondary|Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
1358016|NCT01702428|Secondary|Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358017|NCT01702428|Primary|Anti-rubella Virus Antibody Concentration in Pooled MMR Groups|Antibody concentrations were expressed as GMCs in IU/mL.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||IU/mL||95% Confidence Interval|Geometric Mean
1358018|NCT01702428|Primary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358019|NCT01702428|Primary|Anti-mumps Virus Antibody Concentration in Pooled MMR Groups|Antibody concentrations were expressed as GMCs in EU/mL.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||EU/mL||95% Confidence Interval|Geometric Mean
1358020|NCT01702428|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358021|NCT01702428|Primary|Anti-measles Virus Antibody Concentrations in Pooled MMR Groups|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
1358022|NCT01702428|Primary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358023|NCT01702428|Primary|Anti-rubella Virus Antibody Concentration|Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||IU/mL||95% Confidence Interval|Geometric Mean
1358052|NCT01702311|Secondary|Mean Daily BG|Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG|participants will be followed for the duration of hospital stay, an expected average of 6 days||||mmol/L||Standard Deviation|Mean
1358053|NCT01702311|Primary|Mean Fasting Blood Glucose|The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.|up to 10 days||||mg/dL||Standard Deviation|Mean
1358024|NCT01702428|Primary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358025|NCT01702428|Primary|Anti-mumps Virus Antibody Concentration|Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||EU/mL||95% Confidence Interval|Geometric Mean
1358026|NCT01702428|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358027|NCT01702428|Primary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
1358028|NCT01702428|Primary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|According to protocol (ATP) cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
1358029|NCT01702363|Secondary|Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1358030|NCT01702363|Secondary|Change From BL in Heart Rate Throughout the Treatment Period|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters or at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||beats per minute||Standard Deviation|Mean
1358054|NCT01702298|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of HDL-C.|||Percent change||95% Confidence Interval|Least Squares Mean
1361327|NCT01665053|Secondary|Percentage of Patients That Died at 12 Months.|The Death rate includes Cardiac- & Non-Cardiac Death.|12 months|Intent-to-treat population|||percentage of participants|||Number
1358031|NCT01702363|Secondary|Change From BL in Blood Pressure Throughout the Treatment Period|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1358032|NCT01702363|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per Liter (MMOL/L)||Standard Deviation|Mean
1358033|NCT01702363|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per Liter (µM/L)||Standard Deviation|Mean
1358034|NCT01702363|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International Units per Liter (IU/L)||Standard Deviation|Mean
1358035|NCT01702363|Secondary|Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1358036|NCT01702363|Secondary|Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per Liter (G/L)||Standard Deviation|Mean
1359867|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured 48 hours post-operatively|48 hours post procedure|Only patients for whom 48 hour CK-MB values are available are included in analysis|||ng/mL||Standard Deviation|Mean
1358037|NCT01702363|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per Liter (GI/L)||Standard Deviation|Mean
1358038|NCT01702363|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of cells in blood||Standard Deviation|Mean
1358039|NCT01702363|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|From the first dose of study medication up to 52 weeks|ITT Population|||Participants|||Number
1358040|NCT01702363|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the first dose of study medication up to 52 weeks|Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.|||Participants|||Number
1358041|NCT01702311|Secondary|Number of Subjects With BG > 300 mg/dL||Subjects will be followed over the hospital stay: expected 6 days||||participants|||Number
1358042|NCT01702311|Secondary|Number of BG Within Target|Number of glucose levels within target of 70-140 mg/dl|Participants will be followed over the hospital stay- expected 6 days.||||participants|||Number
1358043|NCT01702311|Secondary|Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]|Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
1358044|NCT01702311|Secondary|Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg|daily while in hospital for up to 10 days||||number of events|||Number
1358045|NCT01702311|Secondary|Bacteremia|Bacteremia with SIRS/Sepsis|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
1358046|NCT01702311|Secondary|Pneumonia|Pneumonia (CDC criteria)|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
1358047|NCT01702311|Secondary|Nosocomial Infections (CDC)|Nosocomial infections during hospital stay as per the CDC criteria|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
1358048|NCT01702311|Secondary|Hospital Mortality|Mortality is defined as death occurring during admission or during the hospital stay|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
1358049|NCT01702311|Secondary|Length of Hospital Stay|Length of hospitalization|participants will be followed for the duration of hospital stay, an expected average of 6 days||||days||Inter-Quartile Range|Median
1358050|NCT01702311|Secondary|Daily Dose of Insulin|Compare the daily dose of insulin used among both groups|participants will be followed for the duration of hospital stay, an expected average of 6 days||||units/day||Standard Deviation|Mean
1358051|NCT01702311|Secondary|Number of Hypoglycemia (BG < 70 mg/dl)|Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups.|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
1358055|NCT01702298|Secondary|Change From Baseline in Triglycerides (TG)|Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS.|||Percent change||95% Confidence Interval|Median
1358056|NCT01702298|Secondary|Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)|Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.|||Percent change||95% Confidence Interval|Least Squares Mean
1358057|NCT01702298|Secondary|Change From Baseline in Total Cholesterol (TC)|Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|"FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements.~One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of TC."|||Percent change||95% Confidence Interval|Least Squares Mean
1358058|NCT01702298|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of LDL-C.|||Percent change||95% Confidence Interval|Least Squares Mean
1358059|NCT01702298|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.|Up to 6 weeks|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.|||Participants|||Number
1358060|NCT01702298|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 8 weeks (including 14 days after final dose of study drug)|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1358061|NCT01702298|Primary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.|Baseline and Week 6|Full analysis set (FAS) defined as all participants who took at least one dose of study medication and had at least one baseline or post-baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1358062|NCT01702259|Secondary|Patient Satisfaction With Study Outcome|"At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:~Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied~Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|2 Weeks||||participants|||Number
1358063|NCT01702259|Secondary|Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.|The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.|Baseline and 2 weeks|The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.|||percentage of TBSA||Standard Deviation|Mean
1358064|NCT01702259|Secondary|Change in Body Weight|Body weight is measured in pounds (lbs) using a digital scale.|Baseline and 2 weeks||||pounds||Standard Deviation|Mean
1358065|NCT01702259|Secondary|Bilateral Upper Thigh Circumference Measurement|Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.|Baseline and 2 weeks||||inches||Standard Deviation|Mean
1358066|NCT01702259|Primary|Number of Subjects That Met the Individual Success Criteria|The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.|Baseline and 2 weeks||||participants|||Number
1358067|NCT01702246|Secondary|Change From Baseline in Total Cholesterol Level After Treatment With Simvastatin||Baseline and 3 months|change in baseline cholesterol level from baseline, after treatment with simvastatin|||mmol/L||Standard Deviation|Mean
1358068|NCT01702246|Secondary|Change in Plasma High Sensitivity C-reactive Protein|Mean difference in plasma high sensitivity C-reactive protein level, before and after treatment with simvastatin|Baseline and 3 months||||mg/mL||Standard Deviation|Mean
1403380|NCT01235338|Primary|AUC of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
1358069|NCT01702246|Primary|Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin|The effect of simvastatin treatment will be assessed by measuring the difference from baseline in the mean frequency (and intensity) of vaso-occlusive pain events, after treatment with simvastatin. Pain rate (proportion of pain days) was defined as the number of days reported with sickle cell disease-related pain divided by the number of daily pain diaries completed.|Baseline and 3 months||||proportion of pain days||Standard Deviation|Mean
1358070|NCT01702233|Secondary|Change From Baseline in DASH at Visit 7 (Day 105)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers.target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy"|Baseline vs. Day 105||||DASH score||Standard Deviation|Mean
1358071|NCT01702233|Secondary|Change From Baseline in DASH at Visit 5 (Day 22)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy.~The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers."|Baseline vs. Day 22||||DASH score||Standard Deviation|Mean
1358072|NCT01702233|Secondary|Painful Arc Test at Visit 5 (Day 22)|The amount of pain that disappeared by further abduction in the range between 60° and 120° was to be measured, with measurement of pain being positive/negative. The idea behind the test is the subacromial space in abduction becomes smaller, whereby compression of the rotator cuff and the subacromial bursa occurs (impingement test).|Baseline vs. day 22||||participants|||Number
1358073|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 22) With Measurement of Weakness|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician’s attempts to depress the upper arm to look for muscle weakness.|Baseline vs. day 22||||participants|||Number
1358074|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 15) With Measurement of Pain|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician’s attempts to depress the upper arm to look for muscle weakness.|Baseline vs. Day 22||||participants|||Number
1358075|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 105||||degrees||Standard Deviation|Mean
1358076|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22||||degrees||Standard Deviation|Mean
1358077|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. day 105||||degrees||Standard Deviation|Mean
1358078|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22||||degrees||Standard Deviation|Mean
1358079|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Fortecortin at Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. day 105||||units on a scale, mm||Standard Deviation|Mean
1358080|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Placebo Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 105||||units on a scale, mm||Standard Deviation|Mean
1358081|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation – Comparison With Placebo Visit 5 (Day 22)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 22||||Change in mm baseline vs. day 22||Standard Deviation|Mean
1358082|NCT01702233|Primary|Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). Change = (Day 22 score -- baseline score).|Baseline to Day 22|Per protocol population|||units on a scale (mm)||Standard Deviation|Mean
1358094|NCT01701973|Primary|Aim 1: Percent Change From Baseline in Forearm Vascular Resistance|Forearm blood flow was determined by strain gauge plethysmography. Forearm vascular resistance was then calculated by dividing this into mean arterial pressure. The percent change from baseline was determined at each timepoint.|Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes||||percentage change from baseline||Standard Deviation|Mean
1361328|NCT01665053|Secondary|Percentage of Participants With Non-Cardiac Death at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
1358083|NCT01702025|Primary|Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).|After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.|The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia||||minutes||Standard Error|Mean
1358084|NCT01701999|Other Pre-specified|Collected Plasma Volume|Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.|Week 1 to Week 12|Participants in Part 1 were only analyzed for safety data, and one participant in Part 2 was excluded from plasma collection due to not meeting the plasma donor minimum weight requirement.|||mL||Standard Deviation|Mean
1358085|NCT01701999|Secondary|Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve|Proportion of participants achieving a two-fold increase in the area under the plasma NAC-time curve between Week 0 and Week 12 in comparison with a straight-line extension of the Week 0 NAC to Week 12 for both botulinum toxin A and toxin B. A proportion ≥ 0.50 was considered a success.|Week 0 to Week 12||||proportion of participants|||Number
1358086|NCT01701999|Secondary|Three-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a three-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success)|Week 0 to Week 4||||proportion of participants|||Number
1358087|NCT01701999|Primary|Four-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a four-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success).|Week 0 to Week 4||||proportion of participants|||Number
1358088|NCT01701973|Secondary|Aim 2: Measurement of Growth Hormone (GH) Levels|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Growth hormone secretion following arginine stimulation was assessed at each visit. Growth hormone levels were determined using an assay that is not subject to interference by pegvisomant.|baseline and every 30 minutes until 180 minutes|Five of the original 29 women returned for an additional two study days separated by a wash-out period. As pre-specified in the protocol, men did not complete this portion of the study. We did not measure GH levels in participants who received LNMMA or Exendin 9-39 as these drugs are not known to influence GH secretion.|||ng/mL||Standard Error|Mean
1358089|NCT01701973|Secondary|Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Tissue plasminogen activator activity (tPA) was assessed at each visit.|baseline and every 30 minutes until 180 minutes|Five of the original 29 women returned for two more study days separated by a wash-out. As pre-specified in the protocol, men did not complete this portion of the study. We do not report tPA results from participants who received LNMMA and Exendin 9-39 in this table as the manufacturer changed the tPA assay standard and results were not comparable.|||IU/ml||Standard Error|Mean
1358090|NCT01701973|Secondary|Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels|In Aim 1 subjects underwent two study days separated by a washout period. On one study day they received study drug and on another placebo, in a randomized double-blind fashion. Venous blood samples were obtained at each visit.|baseline and every 30 minutes for 180 minutes|Data from the first 14 subjects (7 men and 7 women) who completed both study days in Aim 1 were analyzed. We do not report tPA results from the remaining participants as the manufacturer changed the tPA assay standard and results were not comparable.|||IU/ml||Standard Error|Mean
1358091|NCT01701973|Primary|Aim 2: Percent Change From Baseline in Forearm Vascular Resistance|Subjects undergo two study days separated by a washout period. On one study day they will receive sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit every 30 minutes for 3 hours. This was divided into mean arterial pressure to determine forearm vascular resistance.|Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes|19 of the original 29 females who participated in Aim 1 returned to complete an additional two study days (Aim 2) in which they received sitagliptin + double-blinded study drug vs. sitagliptin plus placebo in a cross-over study. Three men from Aim 1 also returned to complete two more study days (Aim 2).|||percent change from baseline||Standard Error|Mean
1358092|NCT01701973|Primary|Aim 2: Percent Change From Baseline in Forearm Blood Flow|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit.|Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.|19 of the original 29 females in Aim 1 returned to complete two more study days (Aim 2) in which they received sitagliptin + double-blinded study drug vs. sitagliptin plus placebo in a cross-over study. Three men from Aim 1 also returned to complete two more study days (Aim 2).|||percent change from baseline||Standard Error|Mean
1358093|NCT01701973|Primary|Aim 1: Percent Change From Baseline in Forearm Blood Flow|Forearm blood flow was determined by strain gauge plethysmography. The percent change from baseline was determined at each timepoint.|Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.|Data from all subjects who completed both study days in Aim 1 were analyzed. Subjects represented young, healthy adults without any chronic medical conditions and who did not take any medications. Oral birth control use was not permitted.|||percent change from baseline||Standard Deviation|Mean
1358115|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1361329|NCT01665053|Secondary|Percentage of Participants With Cardiac Death at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
1358095|NCT01701973|Primary|Aim 1: Stimulated Peak Growth Hormone Level|Subjects underwent two study days separated by a washout period. On one study day they will receive sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine (30 grams i.v. over 30 minutes) on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.|Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes|Data from all subjects who completed both study days in Aim 1 were analyzed. Subjects represented young, healthy adults without any chronic medical conditions and who did not take any medications. Oral birth control use was not permitted.|||ng/ml||Standard Deviation|Mean
1358096|NCT01701674|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) per RECIST V1.1, defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|42 months|All participants.|||months||Full Range|Median
1358097|NCT01701674|Secondary|Overall Response Rate (ORR)|Overall Response: Complete Response (CR) + Partial Response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by computed tomography (CT) scan. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions..|12 weeks|All participants.|||percentage of participants|||Number
1358098|NCT01701674|Primary|Rate of Meeting Feasibility Requirements|Number of participants who were successfully treated with at least 2 doses of ipilimumab and received TIL. Feasibility is defined as the ability to deliver at least 50% (i.e., two out of four) of the planned doses of ipilimumab and successfully treat at least 60% (i.e., ≥ 6/10) of the patients with TIL.|3 months|All participants|||Participants|||Count of Participants
1358099|NCT01701674|Primary|Occurrence of Dose Limiting Toxicity (DLT) Events|Occurrence of adverse events with dose limiting toxicity, per adverse event category.|3 months|All participants|||DLT events|||Number
1358100|NCT01701622|Secondary|If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)|measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.|Participants will be followed for an expected average of 4 to 5 weeks.|||||||
1358101|NCT01701622|Primary|BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings|The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.|4 to 5 weeks|no analysis, as only one participant||||||
1358102|NCT01701505|Secondary|Incidence of Adverse Events by Dose Level Regardless of Age||from baseline to 24 hours following drug administration||||Participants|||Count of Participants
1358103|NCT01701505|Secondary|Number of Participants With Adverse Events by Dose Level and Age||from baseline to 24 hours following drug administration|Patients grouped by age|||Participants|||Count of Participants
1358104|NCT01701505|Secondary|Oxygen Saturation||At Baseline, 12 minutes, and 120 minutes||||percent||Standard Deviation|Mean
1358105|NCT01701505|Secondary|Heart Rate||At Baseline, 12 minutes, and 120 minutes||||bpm||Standard Deviation|Mean
1358106|NCT01701505|Secondary|Diastolic Blood Pressure||At Baseline, 12 minutes, and 120 minutes||||mmHg||Standard Deviation|Mean
1358107|NCT01701505|Secondary|Systolic Blood Pressure||At Baseline, 12 minutes, and 120 minutes||||mmHg||Standard Deviation|Mean
1358108|NCT01701505|Secondary|Naris Examination (NE) to Assess Reactions to the Study Drug.|The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.|At Baseline and 120 Minutes||||Participants|||Count of Participants
1358109|NCT01701505|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 14 minutes with a 3 minute window||||Participants|||Count of Participants
1358110|NCT01701414|Primary|Number of Participants Reporting at Least One NRS Rating|Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.|30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.||||Participants|||Number
1358111|NCT01701401|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR~Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment~Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1358112|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1358113|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1358114|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1358120|NCT01701401|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)|SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1358121|NCT01701375|Secondary|To Determine the Maximal Tolerated Dose (MTD) of PD 0332991 in Timed Sequential Combination With Ara-C and Mitoxantrone|Dose escalation decisions will be based on nonhematologic toxicities in Cycle 1 (28 days) and hematologic toxicities, in the case of an aplastic marrow through Day 56, For cytopenias including ANC < 500/mm3 or platelets < 50, 000/mm3 a bone marrow will be performed between days 42 and 49.. Dose limiting toxicity (DLT) will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days|||||||
1358122|NCT01701375|Primary|The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.|The number of participants experiencing toxicities of administration of PD 0332991 in combination with cytarabine and mitoxantrone will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days||||participants|||Number
1358123|NCT01701362|Secondary|Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%|Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Percentage of participants|||Number
1358124|NCT01701362|Secondary|Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.|Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Percentage of participants|||Number
1358125|NCT01701362|Secondary|Percentage of Participants in MOS-SS With Optimal Sleep Status.|MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.|Week 15|ITT population: all randomized subjects who took at least one dose of study drug|||Percentage of participants|||Number
1358126|NCT01701362|Secondary|Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.|"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.~Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.~Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.~Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.~Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours."|Week 15|ITT population: all randomized participants who took at least one dose of study drug.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1358127|NCT01701362|Secondary|Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.|"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.~Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.~Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.~Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.~Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours."|Baseline|ITT population: all randomized participants who took at least one dose of study drug.|||Units on a scale||Full Range|Median
1358128|NCT01701362|Secondary|Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores|A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant’s overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Units on a scale||Standard Error|Least Squares Mean
1358192|NCT01700816|Secondary|Serum Creatinine and Blood Urea Nitrogen (BUN)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||mg/dl||Inter-Quartile Range|Median
1403381|NCT01235338|Primary|AUC of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
1358129|NCT01701362|Secondary|Change From Baseline in Pain Interference Index (BPI-sf)|"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.~It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).~The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores."|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
1358130|NCT01701362|Secondary|Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])|A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
1358131|NCT01701362|Secondary|Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)|"This is an 11-point NRS ranging from 0 (“pain does not interfere with sleep”) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.~Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week ’n’ mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.~Overall is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks."|up to Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Deviation|Mean
1358132|NCT01701362|Secondary|Patient Global Impression of Change (PGIC) at Week 15|A self administered instrument that measures changes in participants’ overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Participants|||Number
1358133|NCT01701362|Primary|Change From Baseline to Week 15 in Weekly Mean Pain Score|This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|up to Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
1358134|NCT01701362|Primary|Baseline Mean Pain Score|This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Deviation|Mean
1358135|NCT01701271|Primary|Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.|Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis|||hairs/square inch||Full Range|Mean
1358136|NCT01701271|Secondary|Change of Sebum on a Sebum-meter|Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.|baseline and 90 days|Good state of general health Suffering from hair loss|||mg sebum/c^2||Full Range|Mean
1358137|NCT01701271|Primary|Change of the Amount of Hair Loss in a Pull Test|"Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.~Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair"|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis|||Fallen hair||Full Range|Mean
1358138|NCT01701258|Primary|The Effect of Diagnosis on Cortisol Reactivity|"This is a measure of area under the curve in relation to ground, a measure of total cortisol output, in response to acute stress. The acute stressor was the Maastricht Acute Stress Test (MAST). The area under the curve includes all 5 cortisol measures, with one measure before the stressor and the other four measures collected after the stressor. Given that the cortisol data were positively skewed, the cortisol measures were normalized via a log transformation prior to calculating the area under the curve.~Area under the curve with respect to ground (AUCG) is calculated AUC_g=(((cort2_log + cort1_log) * cort_t1_time) / 2)+(((cort3_log+cort2_log)*cort_t2_time)/2)+(((cort4_log+cort3_log)*cort_t3_time)/2)+(((cort5_log+cort4_log)*cort_t4_time)/2). Cort_logs are the log transformed cortisol output data (ng/ml) and the cort_times are the time spans in between each cortisol assessment."|3 hour EEG Session (Session 4)||||[log (ng/ml)]*min||Standard Error|Mean
1358139|NCT01701258|Primary|Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback|"This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward feedback during the monetary incentive delay task (MID).~Striatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation."|3 hour Session 2 (fMRI session)||||beta weight (slope)||Standard Error|Mean
1358211|NCT01700439|Secondary|Subject’s Effective Orifice Area Index (EOAI) Measurement at 1 Year|Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography|1 year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||centimeters squared/meters squared||Standard Deviation|Mean
1358140|NCT01701258|Primary|Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues|"This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward cues during the monetary incentive delay task (MID).~Striatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation."|3 hour Drug & fMRI Session (Session 2)||||beta weight (slope)||Standard Error|Mean
1358141|NCT01701258|Primary|Cortisol Output in Response to a Stress Manipulation|This statistic shows the impact of the stress manipulation on the participant's salivary cortisol output. Saliva samples were collected at 5 distinct time points throughout the study session. The first saliva sample (Cort 1) was collected when the participant began the eeg session. The second (Cort 2)was taken at the end of the acute stressor. The third (Cort 3) was taken approximately fifteen minutes after the second. The fourth (Cort 4) was taken approximately ten minutes after the third. The fifth (Cort 5) was taken approximately 40 minutes after the fourth.|3 hour EEG Session (Session 4)||||ng/ml||Standard Error|Mean
1358142|NCT01701258|Primary|The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress|"EEG was recorded during the probabilistic reward task (the PRT task). Participants completed the Probabilistic Reward Task (PRT) twice throughout the experiment, once before stress and once after stress. The stressor was the Maastricht Acute Stress Test (MAST). This statistic shows the effect that childhood sexual abuse (CSA) and diagnosis had on a reward-related positivity EEG component recorded during the PRT, before and after stress.~Higher reward positivity amplitudes indicate a stronger neural response to reward and lower amplitudes indicate a lower neural response to rewards."|3 hour EEG Session (Session 4)||||amplitude (microvolts)||Standard Error|Mean
1358143|NCT01701258|Primary|The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress|The participant's performance on the Probabilistic Reward Task (PRT) was assessed both before and after an acute stressor. The PRT is a behavioral task that measures an individual's ability to learn from rewarding stimuli and incorporate this learning into their response style (response bias). The acute stressor was the Maastricht Acute Stress Test (MAST). The score obtained is a ratio of the number of times participants correctly choose the high reward stimuli versus the low rewarding stimuli. Response bias scores range between -1 and +1. Higher response bias scores indicate a stronger response bias toward high reward stimuli. A negative response bias indicates a stronger bias toward low reward stimuli.|3 hour EEG Session (Session 4)||||Ratio (Response Bias Score)||Standard Deviation|Mean
1358144|NCT01701258|Primary|Dopamine Active Transporter Binding Potential|"Utilizing 11C-altropane during positron emission tomography (PET) scanning allows us to measure dopamine active transporter (DAT) binding potential.~Our outcome measure is Nondisplacable Binding Potential (BPND). BPND refers to the ratio at equilibrium of specifically bound radioligand to that of nondisplaceable radioligand in tissue.~*Higher BPND scores indicate greater binding potential"|1 hour PET scan (Session 3)||||Ratio||Standard Error|Mean
1358145|NCT01701245|Secondary|EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.~Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index~Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state"|10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks)|Changes between baseline and randomized period.Randomized period and open label. FAS Unmatched data.|||units on a scale||Full Range|Mean
1358146|NCT01701245|Secondary|Adverse Events|The frequency of device effects will be compared between the two treatment groups. Only effects which are new after baseline or have increased severity after baseline will be used in the comparison.|10 weeks|Safety population The Adverse Device effects are reported as Adverse Event, the device effects are AEs that are considered related to the treatment. Graded mild, moderate and severe|||participants|||Number
1358147|NCT01701245|Secondary|Pain Relief of Headache Attacks|"The median pain during baseline (2 weeks) will be compared with the last 14 days of the treatment period Scale 0-4 0= no pain~mild pain~moderate pain~severe pain~very severe pain"|baseline (2 weeks) and random period(last 2 weeks)|"Median severity per subject in run in period (14 days) and the last 14 Days in the treatment period.~FAS matched data set"|||participants|||Number
1358148|NCT01701245|Primary|A Change in the Frequency of Cluster Headache Attacks Per Week|The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) – number of CH attacks during run-in.|4 weeks|Full analysis set (FAS), matched group.|||CH attacks per week||Standard Deviation|Mean
1358149|NCT01701115|Secondary|Side Effects|Incidence of nausea|Postoperative Day 2||||Participants|||Count of Participants
1358150|NCT01701115|Secondary|Duration of Analgesia|Time to pain|Postoperative Day 2||||minutes||95% Confidence Interval|Median
1358151|NCT01701115|Secondary|Patient Readiness to Discharge||Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)||||minutes||Standard Deviation|Mean
1358152|NCT01701115|Primary|Handgrip Strength|The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.|Difference between between baseline and postoperative.||||kg||Standard Deviation|Mean
1358153|NCT01701102|Primary|Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)|The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery|Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.||||minutes||Inter-Quartile Range|Median
1373987|NCT01521260|Secondary|Radiographic Marginal Bone Level on Standardized Intraoral Radiographs||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1358154|NCT01701063|Secondary|Elimination Half-Life (T1/2) of Telaprevir|T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Half life was not calculated because the calculation required the slope of terminal elimination phase and the PK sampling was relatively sparse and did not yield a terminal elimination phase from which half-life can be accurately estimated.||||||
1358155|NCT01701063|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir|AUC was measured for telaprevir only. AUC 0-t last was defined as the area under the concentration-time curve from the time of dosing to the last measurable concentration. AUC 0-12 hour (AUC 0-12h) was calculated by respecifying predose concentrations as 12 hour concentrations. AUC 0-24h was calculated as AUC 0-12h multiplied by 2. Dose adjusted AUC (AUC 0-24h_Adj) was calculated by multiplying AUC 0-24h by the dose adjustment factor to obtain projected exposures in participants who were misdosed. Data were presented for AUC 0-t last, AUC 0-12h, AUC 0-24h, AUC 0-24h_Adj.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
1358156|NCT01701063|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir|Tmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||hours (h)||Full Range|Median
1358157|NCT01701063|Secondary|Maximum Plasma Concentration (Cmax) of Telaprevir|Cmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Pharmacokinetic (PK) population included all participants who received at least a single dose of telaprevir, whether the participant completed all treatments or not. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1358158|NCT01701063|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by age.|Baseline, On treatment (up to Week 48)|FAS. Here ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome and ‘n’ signifies those who were evaluable at the specified time point.|||participants|||Number
1358159|NCT01701063|Secondary|Percentage of Participants With Virologic Relapse|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Viral relapse was defined as having detectable HCV at follow-up in participants who had HCV RNA less than (<) lower limit of quantification (LLOQ) at planned EOT.|12 weeks after planned EOT (up to Week 60)|FAS included all enrolled participants who received at least 1 dose of study drug. Here 'Number of Participants Analyzed' signifies those participants who completed the assigned treatment period and had undetectable HCV RNA at EOT.|||percentage of participants|||Number
1358160|NCT01701063|Secondary|Percentage of Participants With On-treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Futility rules: 1) HCV RNA >1000 IU/mL at Week 4; 2) HCV RNA >1000 IU/mL at Week 12; 3) Detectable HCV RNA after Week 12 to end of treatment.|Baseline up to Week 48|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1358161|NCT01701063|Secondary|Percentage of Participants With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1358162|NCT01701063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. eRVR was defined as an undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1358163|NCT01701063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. RVR was defined as an undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1358164|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (< lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|SVR24 was not analyzed because study was terminated early and follow-up was conducted only up to 12 weeks after planned end of treatment (EOT).||||||
1358212|NCT01700439|Secondary|Subject’s Effective Orifice Area (EOA) Measurement at 1 Year|Hemodynamic performance - Effective Orifice Area (EOA) evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Centimeters squared||Standard Deviation|Mean
1358165|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (less than [<] lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/High Pure System (HPS) RNA assay version 2.0. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1358166|NCT01701063|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 52|Safety set included all participants who received at least 1 dose of study drug.|||participants|||Number
1358167|NCT01701037|Secondary|Percentage of Biopsies With Adequate Tissue for Biomarker Analysis|Measured by the percent of tumor necrosis on hematoxylin and eosin stains; RNA gel electrophoresis, percent of adequate tissue for immunohistochemical stains in tissue microarray and cyTOF analysis.|Up to 3 months||||percentage of biopsies w/adequate tissue|||Number
1358168|NCT01701037|Secondary|Percent of Patients Completing Second and Third (Surgical) Biopsies|Biopsies will be assessed whether or not tissue is acquired at specified time points. Tissue is obtained through core, punch, incisional or excisional biopsy or surgical resection, based upon the clinical situation. Standard operating procedures for biopsies, sample preparation and analysis have been defined.|Up to 3 months||||percentage of participants|||Number
1358169|NCT01701037|Secondary|Investigational Agent Taken|Median number of pills taken|Up to 3 months||||Number of pills taken||Standard Deviation|Median
1358170|NCT01701037|Secondary|Number of Patients With Worst Grade Toxicities by Grade According to National Cancer Institute (NCI) CTCAE Version 4.0|"The intensity of the adverse event will be graded according to Version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (June 14, 2010):~Grade 1 - Mild Grade 2 - Moderate Grade 3 - Severe or medically significant Grade 4 - Life-threatening Grade 5 - Death related to adverse event"|Up to 3 months||||participants|||Number
1358171|NCT01701037|Secondary|Change in Tumor Volume Reduction in Participants With Intrinsic Resistance to B-RAF Targeted Therapy From Day 14 to Day 28.|Tumor volume reduction is calculated as the tumor volume change relative to the baseline measurement (percent). Change in tumor volume reduction from day 14 to day 28 is calculated as the difference of tumor volume reduction at day 28 and day 14. The median and Inter-Quartile Range are reported.|Day 14 and day 28||||percentage of reduction||Inter-Quartile Range|Median
1358172|NCT01701037|Primary|Clinical Tumor Response Rate (Response is Based on Greater Than 30% Reduction From Baseline in Tumor Volume by RECIST Criteria) at Day 14.|Tumor response is defined as greater than 30% reduction from baseline in tumor volume by RECIST criteria. To determine whether a patient is responded at day 14, the patient must have the tumor volume evaluated at both baseline and day 14. The tumor response rate is calculated as the proportion of patients responded among all evaluated patients.|day 14||||proportion of responders||95% Confidence Interval|Number
1358173|NCT01701024|Primary|Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear||Baseline and 12 Weeks||||percentage of clear or almost clear|||Number
1358174|NCT01701024|Primary|Percent of Subjects Who Have a Least a 2 Grade Reduction||Baseline and 12 Weeks||||Percent with >2% reduction|||Number
1358175|NCT01701024|Primary|Absolute Change in Non-inflammatory Lesion Count||Baseline and 12 Weeks||||lesion count||Standard Deviation|Mean
1358176|NCT01701024|Primary|Absolute Change in Inflammatory Lesion Count||Baseline and 12 Weeks||||Lesion count||Standard Deviation|Mean
1358177|NCT01701011|Secondary|Depression|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0–7), mild (8–10), moderate (11–14) and severe (15–21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer|||units on a scale||Standard Error|Mean
1358178|NCT01701011|Primary|Anxiety|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0–7), mild (8–10), moderate (11–14) and severe (15–21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer|||units on a scale||Standard Error|Mean
1358193|NCT01700816|Secondary|Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||mmol/L||Inter-Quartile Range|Median
1358194|NCT01700816|Secondary|Hospital Length of Stay||From admission to hospital to discharge, an expected average of 28 days post-transplant|One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.|||days||Inter-Quartile Range|Median
1358179|NCT01700959|Secondary|Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.|Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson’s R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.|Baseline and six months after start of therapy|Analysis based on intent to treat includes Cohort 2 participants randomized to melatonin who completed the 6-month assessment. Cohorts 1 and 3 were not assessed. 2 assessments of the primary outcome collected in Cohort 2 included self-report and actigraphy. 50 is the total number with actigraphy data. Data were missing for 12 participants.|||Z-score|||Number
1358180|NCT01700959|Secondary|Sleep Onset Latency as Measured by Actigraphy and Self-report.|Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.|Baseline and six months after start of therapy|Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment.|||minutes||Standard Deviation|Mean
1358181|NCT01700959|Primary|Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.|Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.|Baseline and 6 months after start of therapy|Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.|||Z-score||Standard Deviation|Mean
1358182|NCT01700907|Secondary|The Incidence of Postoperative Delirium|The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.|from 15 minutes to 48 hrs postoperatively|This is a pilot study.|||participants|||Number
1358183|NCT01700907|Secondary|Cognitive Function|Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.|24 hrs pre and postoperatively|This is a pilot study|||Scores on a scale||Inter-Quartile Range|Median
1358184|NCT01700907|Secondary|The Time From the End of Anesthesia to Following Commands|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.|||second||Inter-Quartile Range|Median
1358185|NCT01700907|Secondary|The Time From the End of Anesthesia to Eye Opening|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.|||second||Inter-Quartile Range|Median
1358186|NCT01700907|Primary|The Time From the End of Anesthesia to Extubation|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.|||second||Inter-Quartile Range|Median
1358187|NCT01700816|Secondary|Platelet Count|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||thousand cells/uL||Inter-Quartile Range|Median
1358188|NCT01700816|Secondary|Hematocrit (HCT)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||volume percentage (vol%) of red blood ce||Inter-Quartile Range|Median
1358189|NCT01700816|Secondary|Hemoglobin (HGB)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||g/dl||Inter-Quartile Range|Median
1358190|NCT01700816|Secondary|White Blood Cells (WBC)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||K/uL||Inter-Quartile Range|Median
1358191|NCT01700816|Secondary|Red Blood Cells (RBC)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||M/uL||Inter-Quartile Range|Median
1358196|NCT01700816|Secondary|Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)|"Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.~10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.~A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium"|From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant|Only one case of delirium developed, and only an MDAS score was collected for this participant.|||units on a scale|||Number
1358197|NCT01700816|Primary|Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale|Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)|From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant|Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.|||Participants|||Count of Participants
1358198|NCT01700530|Secondary|Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)|% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention|12 weeks||||percent change||Standard Error|Mean
1358199|NCT01700530|Primary|% Change in VO2max (Fitness)|% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max|Change from Baseline to 12 weeks|Statins blocked exercise induced change in fitness|||percentage change of VO2max||Standard Deviation|Mean
1358200|NCT01700517|Primary|Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block|"The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."|48 HOURS|This sample size was calculated for a fixed effects one-way analysis of variance design. It was assumed that the standard effect size (d) = 0.5, the level of alpha (two-tailed) = 0.05, and power = 0.8, resulting in twenty six patient. The sample was stratified, having 40 patients in each of three groups to compensate for expected dropouts|||units on a scale||95% Confidence Interval|Mean
1358201|NCT01700439|Other Pre-specified|Subject’s Average Plasma Free Hemoglobin at 1 Year|Laboratory Analysis of Plasma Free Hemoglobin of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||mg/dL||Standard Deviation|Mean
1358202|NCT01700439|Other Pre-specified|Subject’s Average Hemoglobin Percentage at 1 Year|Laboratory analysis of Hemoglobin of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||g/dL||Standard Deviation|Mean
1358203|NCT01700439|Other Pre-specified|Subject’s Average Hematocrit Percentage at 1 Year|Laboratory analysis of Hematocrit of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Percentage of RBC||Standard Deviation|Mean
1358204|NCT01700439|Other Pre-specified|Subject’s Average Red Blood Cell Count at 1 Year|Laboratory analysis of Red Blood Cell Count of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||10^6 cells/microliters||Standard Deviation|Mean
1358205|NCT01700439|Other Pre-specified|Subject’s Average White Blood Cell Count at 1 Year|Laboratory analysis of White Blood Cell Count on blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||10^3 cells/microliters||Standard Deviation|Mean
1358206|NCT01700439|Other Pre-specified|Subject’s Average Score at Baseline and 1 Year on the Quality of Life Survey|The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.|Baseline and one year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Units on a scale||Standard Deviation|Mean
1358207|NCT01700439|Secondary|Amount of Aortic Valvular Regurgitation in Subjects at 1 Year by Valve Size|Hemodynamic performance - Aortic valvular regurgitation evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available. Each subject can only receive one valve and results are presented by valve size. The number of participants in each of the valve sizes totals up to the overall number analyzed.|||Participants|||Count of Participants
1358208|NCT01700439|Secondary|Subject’s Cardiac Index Measurement at 1 Year|Hemodynamic performance - Cardiac index evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Liters/minutes/meters squared||Standard Deviation|Mean
1358209|NCT01700439|Secondary|Subject’s Cardiac Output Measurement at 1 Year|Hemodynamic performance - Cardiac Output evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Liters/minutes||Standard Deviation|Mean
1358210|NCT01700439|Secondary|Subject’s Performance Index Measurement at 1 Year|Hemodynamic performance - Performance Index evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Centimeters squared/meters squared||Standard Deviation|Mean
1358238|NCT01700348|Secondary|Plaque|Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.|4 Weeks|||||||
1358213|NCT01700439|Secondary|Subject’s Average Gradient Measurements at 1 Year|Hemodynamic performance - Mean and peak gradients evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||mmHg||Standard Deviation|Mean
1358214|NCT01700439|Secondary|Subject’s Percentage of Change at 1 Year From Baseline in New York Heart Association (NYHA) Class|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.~Symptoms of heart failure or the anginal syndrome may be present even at rest."|Baseline and one year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Participants|||Count of Participants
1358215|NCT01700439|Secondary|Average Number of Days Subjects Were in the Intensive Care Unit (ICU)|Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.|Day of procedure through discharge from the hospital|Data is not available for 5 subjects.|||Days||Standard Deviation|Mean
1358216|NCT01700439|Secondary|Average Subject Time on Cardiopulmonary Cross Clamp|Surgical and hospitalization factors - Cardiopulmonary cross clamp time|Day of procedure|Data is not available for 3 subjects.|||Minutes||Standard Deviation|Mean
1358217|NCT01700439|Secondary|Average Amount of Time Subject Spent on Cardiopulmonary Bypass|Surgical and hospitalization factors - Cardiopulmonary bypass time|Day of procedure|Data is not available for two subjects.|||Minutes||Standard Deviation|Mean
1358218|NCT01700439|Secondary|Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success|Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.|Day of procedure through discharge or 10 days post index procedure, whichever comes first.|This outcome is reported for enrolled subjects where data is available.|||Percentage of subjects|||Number
1358219|NCT01700439|Secondary|Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success|Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.|Day of procedure|This outcome is reported for enrolled subjects where data is available.|||Percentage of subjects|||Number
1358220|NCT01700439|Primary|Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)|Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]|Events occurring ≥ 31 days and up through 2 years post-implant||||Percentage of events/late patient years|||Number
1358221|NCT01700387|Secondary|Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life||12 Months|||||||
1358222|NCT01700387|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||13 Months|||||||
1358223|NCT01700387|Secondary|Pharmacoeconomic Estimates on Number of Patients Needed to Treat (Randomize) to Have One Successful Patient at 3, 6, 9, and 12 Months.||12 Months|||||||
1358224|NCT01700387|Secondary|Subject Estimation of Compliance With Daily Topiramate||12 Months|||||||
1358225|NCT01700387|Secondary|MEWT Scores for Mathematical Processing Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months|||||||
1358226|NCT01700387|Secondary|MEWT Scores for Matching to Sample Sub-test at Visit 2-6 to Measure Mental Efficiency||12 Months|||||||
1358227|NCT01700387|Secondary|MEWT Score for Running Memory Continuous Performance Task Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months|||||||
1358228|NCT01700387|Secondary|MEWT Score for Simple Reaction Time Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months|||||||
1358229|NCT01700387|Secondary|Subject's Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life||12 Months|||||||
1358230|NCT01700387|Secondary|Change in Number of Headache Days Reported in 30-day Baseline Period vs. Treatment Period Months 1-12||13 Months|||||||
1358231|NCT01700387|Primary|Subject's Controlled Oral Word Association Test (COWAT) Scores at Visits 2-6 to Measure Cognitive Efficiency||12 Months|||||||
1358232|NCT01700387|Primary|Subject's Mental Efficiency Workload Test (MEWT) Overall Performance Index (PI) Score at Visits 2-6 to Measure Cognitive Efficiency||12 Months|||||||
1358233|NCT01700387|Primary|Physician Global Impression of Change (PGIC)|Score on Physician Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.|||units on a scale||Standard Deviation|Mean
1358234|NCT01700387|Primary|Subject Global Impression of Change (SGIC)|Score on Subject Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.|||units on a scale||Standard Deviation|Mean
1358235|NCT01700387|Primary|Subject Attrition Post Randomization|Count of subject attrition following randomization and reason for attrition (Consent withdrawn, Withdrawn due to adverse event, Lost to follow up)|Collected on Visit 2 (Day 29) through Visit 6 (Day 365)||||participants|||Number
1358236|NCT01700348|Secondary|Percentage of Bleeding Sites|Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks|||||||
1358237|NCT01700348|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assess the safety of the Sonicare AirFloss + MTB treatment.|4 Months|||||||
1358241|NCT01700348|Primary|The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group|The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.|Four Months|||||||
1358242|NCT01700335|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 16 weeks|||||||Number
1358243|NCT01700335|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)|"Definition~Hematologic Improvement Erythrocyte (HI-E):~Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation~Hematologic Improvement Platelet (HI-P):~Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%~Hematologic Improvement Neutrophil (HI-N):~At least 100% increase and an absolute increase > 0.5×10^9/L~Progressive disease / Relapse:~At least 1 of the following:~At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 60 weeks||||participants|||Number
1358244|NCT01700335|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)|"Definition~Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%~Partial remission (PR) Same as CR criteria except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%~Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR~Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 wks~Disease progression~Patients with:~Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts~Any of the following:~At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks||||participants|||Number
1358245|NCT01700335|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 2. DLTs were also to be assessed in the Efficacy and Safety Assessment Committee.~Criteria:~Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)~Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 60 weeks||||participants|||Number
1358246|NCT01700192|Secondary|Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment|"Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (no symptoms) to 100 (severe symptoms). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores)."|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
1358247|NCT01700192|Secondary|Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment|The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
1358248|NCT01700192|Secondary|Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment|The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
1358249|NCT01700192|Secondary|Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment|The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
1358250|NCT01700192|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 52 weeks|The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).|||Participants|||Number
1358251|NCT01700192|Primary|Number of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 54 weeks|The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).|||Participants|||Number
1358267|NCT01700036|Secondary|Percentage of Patients Who Achieve a Complete Response to Treatment|"To estimate the proportion of patients in complete remission without additional therapy at four weeks after the last dose of AAT~Complete remission is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0."|4 weeks||||percentage of patients||95% Confidence Interval|Number
1373988|NCT01521260|Secondary|Microbiological Composition of the Peri-implant Sulcus||baseline (T0), 3 and 12 months after intervention (T3, T12)|||||||
1358252|NCT01700192|Primary|Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment|The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
1358253|NCT01700179|Primary|SVR12|To determine the incidence of a sustained virologic response at 12 weeks after the completion of dosing (SVR12) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification (<LOQ) at that time point|12 weeks following last dose||||percentage of subjects|||Number
1358254|NCT01700140|Secondary|Skin Manifestations at Study Drug Application Site|"The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.~Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch)."|Up to 192 hours|"Skin manifestations were counted for each type of patch applied to the subjects in the safety population.~Placebo patch : 60-1+63+60=182 (One subject in placebo group did not applied 15 cm2 patch.)~SyB D-0701 15 cm2 patch : 62~SyB D-0701 25 cm2 patch : 62+63=125"|||Number of events|||Number
1358255|NCT01700140|Secondary|Severe (Grade 3 or More) Adverse Events|"The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.~Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE"|Up to 192 hours|"Safety population:~The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment."|||Number of events|||Number
1358256|NCT01700140|Secondary|Adverse Events|Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.|Up to 192 hours|"Safety population:~The safety population consisted of all subjects enrolled, except for subjects with Good Clinical Practice (GCP) non-compliance and those who failed to receive the study treatment."|||Participants|||Number
1358257|NCT01700140|Secondary|Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.~The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs."|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
1358258|NCT01700140|Secondary|Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.~The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs."|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
1358259|NCT01700140|Secondary|Time to First Nausea|Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Hours||95% Confidence Interval|Median
1358260|NCT01700140|Secondary|Time to First Emesis|Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Hours||95% Confidence Interval|Median
1358261|NCT01700140|Secondary|Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
1358262|NCT01700140|Primary|Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
1358263|NCT01700036|Secondary|Mean Plasma Levels for Alpha-1-Antitrypsin (AAT)|Plasma levels of Alpha-1-Antitrypsin(AAT)will be measured.|4 weeks||||mg/dl||Standard Error|Mean
1358264|NCT01700036|Secondary|Mean Fold Change in Plasma Biomarkers|The fold change in levels of plasma biomarkers IL-6, TNF-alpha and ST2 will be measured pre-treatment and after the administration of AAT treatment for steroid refractory GvHD.|Baseline, 2 weeks, and 4 weeks||||fold change from baseline||Standard Error|Mean
1358265|NCT01700036|Secondary|The Percentage of Patients Alive at 6 Months for Patients in CR or PR|"Survival at 6 months in patients receiving AAT treatment for steroid refractory acute GVHD for patients that achieved a CR or PR.~Partial Response (PR) is defined as a decrease of at least one grade in the severity of GVHD without deterioration of any organ systems by d28 of therapy.~Complete Response (CR) is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0."|6 months|40 patients were enrolled and 26 patients achieved a CR or PR.|||percentage of patients||95% Confidence Interval|Number
1358266|NCT01700036|Secondary|Percentage of Patients With Documented Infection|To estimate the incidence of infection during and following treatment of steroid refractory acute GVHD with AAT|30 days||||percentage of patients|||Number
1373989|NCT01521260|Secondary|Suppuration on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1358268|NCT01700036|Primary|Percentage of Patients That Respond to Treatment|"To estimate the proportion of patients with steroid refractory acute Graft vs Host Disease) GvHD who respond (achieve either PR or CR) to Alpha-1 Antitrypsin (AAT) at a dose of 60mg/kg twice weekly for 8 doses~Partial Response (PR) is defined as a decrease of at least one grade in the severity of GVHD without deterioration of any organ systems by d28 of therapy.~Complete Response (CR) is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0."|4 weeks||||percentage of patients||95% Confidence Interval|Number
1358269|NCT01699867|Primary|Number of Margins With False Positive Device Readings||one week after surgery|Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.|||False positive margins per patient||Standard Deviation|Mean
1358270|NCT01699867|Primary|Patients With All Positive Margins Correctly Identified With the Device|"In this study, a patient had positive margins if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, tumor on ink)."|one week after surgery|"Patients with positive margins (0 mm, tumor on ink)."|||Patients w/ all positives identified|||Number
1358271|NCT01699815|Other Pre-specified|Average Length of Stay (LOS)|To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.|Baseline to discharge (1-4 days)||||days||Standard Deviation|Mean
1358272|NCT01699815|Secondary|Pain Medication Consumption Rates|Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.|Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug||||participants|||Number
1358273|NCT01699815|Primary|Changes in Postoperative Pain Scores|To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain|preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug||||units on a scale||Standard Deviation|Mean
1358274|NCT01699789|Secondary|Park or Community Center Visits With Depression Service if Went to Park or Community Center||6 months follow-up||||percentage of participants||95% Confidence Interval|Mean
1358275|NCT01699789|Secondary|Faith-based Visits With Depression Service if Faith Participation|For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.|6 months follow-up||||percentage of patients||95% Confidence Interval|Mean
1358276|NCT01699789|Secondary|Medication Visits Among MHS Users||6 months follow-up||||percentage of participants||95% Confidence Interval|Mean
1358277|NCT01699789|Secondary|>= 2 PCP Visits With Depression Services, if Any||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358278|NCT01699789|Secondary|>=2 Emergency Room Visits||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358279|NCT01699789|Secondary|>=4 Hospital Nights for Behavioral Health||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358280|NCT01699789|Secondary|Any Missed Work Day in Last 30 Days, if Working||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358281|NCT01699789|Secondary|Working for Pay||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358282|NCT01699789|Secondary|My Life is Organized||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358283|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|12 months follow-up||||mean number of visits||95% Confidence Interval|Number
1358284|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|6 months follow-up||||mean number of visits||95% Confidence Interval|Mean
1358285|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358286|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358287|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358288|NCT01699789|Primary|PHQ-9 Score ≥ 10|Mild/moderate depression defined as PHQ-9 score ≥ 10.|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358289|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358290|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358291|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358292|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358293|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358294|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358295|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1373990|NCT01521260|Secondary|Probing Pocket Depth||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1358298|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358299|NCT01699789|Secondary|Homeless or ≥ 2 Risk Factors for Homelessness|Being homeless or having no place to stay for 2 nights or more; food insecurity; eviction from primary place of residence; or major financial crisis from items in client surveys. Homeless/shelter (pure, demo306=7) or >=2 risk factor for homelessness out of 4 items diff1 diff2 diff11 diff6)|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358300|NCT01699789|Secondary|Physically Active|Items on physical activity that are self-reported in the client survey, drawn from the SF-12 and measures of exercise and physical activity. how physically active you are (cond606>=3), 1=Quite/very/extreme active, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358301|NCT01699789|Secondary|Mental Wellness|Mental Wellness, % (at least good bit of time on 3 items on feeling peaceful or, calm, been a happy person, having energy), at least 1 item out of 3.|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358302|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
1358303|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with YSI plasma Blood Glucose (BG) >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (106) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 106 samples were greater than 180 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
1358304|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)|"Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (107) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 107 samples were less than or equal to 80 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
1358305|NCT01699763|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number 333 (336-3) BG results possible for each BGMS. Staff collected 3 capillary samples from each subject - total 336 samples. Three samples from one subject were not analyzed. Subject hematocrit (58.5) was above the study evaluable limit of 55.|||Percent Difference|Participants|Standard Error|Mean
1358306|NCT01699750|Secondary|Minimum Protected Area|Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||percentage of lens surface covered||Standard Deviation|Mean
1358307|NCT01699750|Secondary|Average Exposure Speed|Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||percent of area exposed/second||Standard Deviation|Geometric Mean
1358308|NCT01699750|Secondary|Overall Dryness Measured With Visual Analog Scale (VAS)|The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1358344|NCT01698814|Primary|Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.|An average of 6 weeks|This reporting group includes all randomized subjects who received study medication.|||participants|||Number
1358309|NCT01699750|Secondary|Overall Comfort Measured With Visual Analog Scale (VAS)|The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.|||units on a scale||Standard Deviation|Mean
1358310|NCT01699750|Secondary|LogMAR Time-Controlled Visual Acuity (TCVA)|Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.|||VA unit||Standard Deviation|Mean
1358311|NCT01699750|Secondary|Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||seconds||Standard Deviation|Geometric Mean
1358312|NCT01699750|Primary|Mean Ex-Vivo Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||micrograms||Standard Deviation|Geometric Mean
1358313|NCT01699698|Secondary|The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.|Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)|1 year||||participants|||Number
1358314|NCT01699698|Primary|The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort|"We hypothesized that there is a statistically-significant difference between two cohorts.~The cancer marker is S100P."|1year||||pg/ml||Full Range|Median
1358315|NCT01699685|Secondary|Airway Resistance (Raw)|Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||cmH2O/l/s||Standard Deviation|Mean
1358316|NCT01699685|Secondary|Total Lung Capacity (TLC)|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
1358317|NCT01699685|Secondary|Forced Volume Capacity (FVC)|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
1358318|NCT01699685|Secondary|Inspiratory Capacity (IC)|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose|within 4h after dosing|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
1358319|NCT01699685|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
1358320|NCT01699685|Primary|Inspiratory Capacity (IC) Peak Value|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis.|||Liters||Standard Deviation|Mean
1358321|NCT01699607|Primary|Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.|PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.|first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration||||percent change in binding potential||Standard Deviation|Mean
1358322|NCT01699373|Secondary|Time Taken to Perform Spinal Anaesthesia||During procedure|||||||
1358323|NCT01699373|Primary|Success Rate of First-attempt of Spinal Anaesthesia||During procedure||||participants|||Number
1358324|NCT01699087|Primary|Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358325|NCT01699087|Primary|Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability|Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358326|NCT01699087|Primary|Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability|Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358327|NCT01699087|Primary|Cumulative Incidence of Ocular Serious Adverse Events by Eye|Participants were followed for the duration of the study, an expected average of 24 months.|Up to Month 24 (post second eye surgery)|ITT|||eyes|eyes||Number
1358328|NCT01699087|Primary|Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits|MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Up to Month 24 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358329|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358330|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358331|NCT01699087|Primary|Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability|Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358332|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability|Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
1358333|NCT01699087|Primary|Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively|Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.|Month 6 (post second eye surgery)|Intent to treat (ITT)|||percentage of eyes|eyes||Number
1358334|NCT01699022|Primary|Serum Progesterone Concentration|"Return of ovulation measured by changes in serum progesterone concentration by~analysis on Day 18, Day 21 (Control cycle), Day 103, Day 106, Day 131 and Day 134 indicating the number of subjects who achieved ovulation"|Day 134||||participants|||Number
1358335|NCT01699022|Primary|T1/2|Mean no of days for MPA and E2|"Day 85"|Tmax|||day||Standard Deviation|Mean
1358336|NCT01699022|Primary|Tmax|Mean serum concentrations of E2 peaked by 3.3 days (range 1 – 7 days) following the third monthly injection|"Day 85"|Tmax|||day||Standard Deviation|Mean
1358337|NCT01699022|Primary|E2 Pharmacokinetics|AUC 0-28, AUC(0-inf)|Day 28||||pg.day/mL||Standard Deviation|Mean
1358338|NCT01699022|Primary|E2 Concentrations|Mean serum E2 concentrations on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and ''Day 85"||||pg/mL||Standard Deviation|Mean
1358339|NCT01699022|Primary|MPA Pharmacokinetics T1/2||"Day 85"||||day||Standard Deviation|Mean
1358340|NCT01699022|Primary|MPA Pharmacokinetics Tmax|Mean serum MPA concentrations peaked at 4.1 days (range 1 – 21 days) after the third monthly administration of Cyclofem.|"Day 85"||||day||Standard Deviation|Mean
1358341|NCT01699022|Primary|MPA Pharmacokinetics Cmax|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem|85 days||||ng/mL||Standard Error|Mean
1358342|NCT01699022|Primary|MPA Pharmacokinetics|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem (AUC)|"Day 85"||||ng.day/mL||Standard Error|Mean
1358343|NCT01699022|Primary|MPA Concentrations|Assessment of mean trough levels of MPA on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and 'Day 85"||||ng/mL||Standard Deviation|Mean
1358345|NCT01698801|Secondary|Number of Participants With Adverse Events|An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.|From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
1358346|NCT01698801|Secondary|Overall Survival (OS)|The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.|||months||95% Confidence Interval|Median
1358347|NCT01698801|Secondary|Progression Free Survival (PFS)|PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.|||months||95% Confidence Interval|Median
1358348|NCT01698801|Secondary|Duration of Response|Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.|From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug|||months||95% Confidence Interval|Median
1358349|NCT01698801|Secondary|Time to Response|"Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).~CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required."|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug|||months||Full Range|Median
1358350|NCT01698801|Primary|Overall Response Rate|"Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.~CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.|||percentage of participants|||Number
1358351|NCT01698775|Secondary|Change From Baseline in eGFR at Week 54|Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.|Baseline and Week 54|APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A.|||mL/min/1.73 m^2||95% Confidence Interval|Least Squares Mean
1358362|NCT01698710|Secondary|Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts|The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.|immediately after procedure||||units on a scale||Full Range|Median
1358363|NCT01698710|Primary|Frequency of Pancreatitis|Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.|3-10 months (median 6 months) after injection therapy||||Participants|||Count of Participants
1358352|NCT01698775|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24|Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.|Baseline and Week 24|APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B).|||mL/min/1.73 m^2||95% Confidence Interval|Least Squares Mean
1358353|NCT01698775|Secondary|Change From Baseline in FPG at Week 54|Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 54|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
1358354|NCT01698775|Secondary|Change From Baseline in A1C at Week 54|A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 54|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.|||Percent||95% Confidence Interval|Least Squares Mean
1358355|NCT01698775|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 24|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
1358356|NCT01698775|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 54 weeks|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
1358357|NCT01698775|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 58 weeks (including 28 days following the last dose of study therapy)|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
1358358|NCT01698775|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 24 weeks|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
1358359|NCT01698775|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)|All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
1358360|NCT01698775|Primary|Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24|A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 24|Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.|||Percent||95% Confidence Interval|Least Squares Mean
1358361|NCT01698710|Secondary|Size of Cystic Lesion|Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.|3-10 months (median 6 months) after injection therapy||||Participants|||Count of Participants
1358972|NCT01690143|Primary|Frequency of Grades 3 and 4 Non-hematologic Adverse Events During the Transplant Component ( 135 Days)|Grading of AE's is performed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 4 1/2 months||||Participants|||Count of Participants
1358364|NCT01698684|Primary|Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing||Week 0 (Baseline) up to Week 8 (End of Study)|The intent-to-treat (ITT) population consists of all subjects who are randomized, take at least 1 dose of study medication, and have at least 1 post-dose efficacy assessment.|||percentage of successes||Standard Deviation|Mean
1358365|NCT01698554|Secondary|Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported."|Month 4|ITT Population included all randomized participants.|||percentage of participants|||Number
1358366|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.|||intensity units||Standard Deviation|Mean
1358367|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.|||mm^2||Standard Deviation|Mean
1358368|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.|||mm||Standard Deviation|Mean
1358369|NCT01698554|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)|The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat (ITT) Population included all randomized participants.|||percentage of participants|||Number
1358370|NCT01698528|Secondary|Time Health Care Providers and Subjects Spend on Managing the Insulin Titration|time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes|3 months||||min||Standard Deviation|Mean
1358371|NCT01698528|Secondary|Number of Participants With Hypoglycemia|Number of participants had hypoglycemia during the trial period|3 months||||Participants|||Count of Participants
1358372|NCT01698528|Secondary|Change in Average Participation Satisfaction|The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.|3 months||||points||Standard Deviation|Mean
1358373|NCT01698528|Secondary|Number of Participants Reaching Target of HbA1c ≤ 7%|Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.|3 months||||Participants|||Count of Participants
1358374|NCT01698528|Primary|Glycemic Control as Determined by the Change in Absolute HbA1c Level|The primary outcome of interest is absolute decrease in A1c by end of 3 months.|3 months||||Percent A1C||Standard Deviation|Mean
1358375|NCT01698502|Secondary|The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).|Comparison of the total release of GIP during the 3 hour OGTT and IIGI.|Test day 1 and 2 within 7 days.||||pmol/L * 210 min||Standard Error|Mean
1358376|NCT01698502|Primary|Incretin Effect (the % of Insulin Secreted Due to the Release of the Intestinal Hormones Glucagon Like Peptide-1 (GLP-1 and Glucose-dependent Insulinotropic Peptide (GIP))|The Incretin effect (the % of insulin secreted due to the release of the intestinal hormones GLP-1 and GIP) is calculated as the difference between the insulin concentration during a 3 hour oral glucose tolerance test (OGTT) (day 1) compared to a 3 hour isoglycemic intravenous glucose infusion (IIGI) (day 2) that has similar glucose excursions.|Test day 1 and 2 within 7 days.||||percentage||Standard Error|Mean
1358377|NCT01698320|Primary|Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52|"The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.~HEENT = head, eyes, ears, nose, throat"|Weeks 0, 12 and 52|Safety population. Participants with assessments at each time point are reported.|||participants|||Number
1358378|NCT01698320|Primary|Change From Baseline in Pulse Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.~Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.|||beats/minute||Standard Deviation|Mean
1358379|NCT01698320|Primary|Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.~Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.|||mmHg||Standard Deviation|Mean
1373991|NCT01521260|Secondary|Bleeding on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1358380|NCT01698320|Primary|Electrocardiogram (ECG) Results At Weeks 0, 12, and 52|A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.|Weeks 0 (screening visit), 12, and 52|Safety population. Participants with assessments at each time point are reported.|||participants|||Number
1358381|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Weeks 13-52|Safety population|||participants|||Number
1358382|NCT01698320|Other Pre-specified|Daily AM Peak Expiratory Flow (PEF) to Week 52|Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.|Baseline to Week 52|||||||
1358383|NCT01698320|Other Pre-specified|Device Invitro Evaluations to Week 52|"Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:~Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing~Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing"|Baseline to Week 52|||||||
1358384|NCT01698320|Other Pre-specified|Composite Measurement of Device Ruggedness From Baseline to Week 52|Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).|Baseline to Week 52|||||||
1358385|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population|||participants|||Number
1358386|NCT01698268|Primary|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.|Admission into PACU||||units on a scale||Inter-Quartile Range|Median
1358387|NCT01697969|Primary|Patient-Assessed Ocular Itching|The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.|Baseline (Day 1), Day 14|The analysis population includes all participants exposed to the test product. Here, “n” is the number of participants with non-missing values at the specific time point.|||units on a scale||Standard Deviation|Mean
1358388|NCT01697956|Secondary|Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population|||participants|||Number
1358389|NCT01697956|Secondary|Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population|||participants|||Number
1358390|NCT01697956|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities).~The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out).~An SAE was defined as an AE that resulted in any of the following:~Death~Life-threatening~Required hospitalization or prolonged existing hospitalization~Persistent or significant disability or incapacity~A congenital abnormality or birth defect~An important medical event which required medical intervention to prevent any of the above outcomes."|Day 1- week 10|Safety population which included all randomized participants who received at least one dose of randomized study medication.|||participants|||Number
1358391|NCT01697956|Secondary|Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, t1/2 for BDP could not be estimated for any participants.|||hours||Standard Deviation|Mean
1358392|NCT01697956|Secondary|Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, λz for BDP could not be estimated for any participants.|||1/hour||Standard Deviation|Mean
1358393|NCT01697956|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.|||hours||Standard Deviation|Mean
1358394|NCT01697956|Secondary|Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day.|||pg/mL||Standard Deviation|Mean
1358395|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.|||h*pg/mL||Standard Deviation|Mean
1358396|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day|||h*pg/mL||Standard Deviation|Mean
1358397|NCT01697956|Primary|Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment|The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.|Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)|Per protocol (PP) population|||ratio||Standard Error|Geometric Mean
1358398|NCT01697696|Secondary|Time to First COPD Exacerbation (Moderate or Severe).|COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required. Rates are calculated using the Kaplan Meier method.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized|||Days||95% Confidence Interval|Median
1358399|NCT01697696|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded by the patients in the eDiary in the morning and evening. The total number of puffs of rescue medication per day over the 52 week treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator. Change from baseline in number of puffs were analyzed using a linear mixed model which contained treatment, baseline number of puffs, baseline smoking status, baseline ICS use and COPD disease severity as fixed effects with center as a random effect|52 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Number of puffs||Standard Error|Least Squares Mean
1358477|NCT01697332|Primary|Spatial Heterogeneity|Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.|4 years|No data analyzed or collected for this outcome measure.||||||
1358400|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|Percentage of days with ‘no daytime symptoms’ A day with ‘no daytime symptoms’ was defined from the diary data as any day where the patient had recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) and no puffs of rescue medication during the past 12 hours (approximately 8 am to 8pm). However, a patient was not considered symptom free if they had used rescue medication that day even if his/her total daytime symptoms score was zero. Percentage of nights with ‘no nighttime awakenings’ A night with ‘no nighttime awakenings’ was defined from diary data as any night where the patient did not wake up due to symptoms. The total number of nights with ‘no nighttime awakenings’ over the treatment period was divided by the total number of nights where diary recordings had been made in order to derive the percentage nights with ‘no nighttime awakenings’.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Percentage of days / nights||Standard Error|Least Squares Mean
1358401|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|The total symptom score was defined as the sum of individual cores for respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and reathlessness. Where a patient had a morning score and an evening score for an individual symptom on one particular day then the worst score was to be taken as the daily score for that symptom. Each symptom scale ranged from 0-3 where 0 was no symptoms and 3 was the worst. The total daily/daytime/nighttime symptom score consists of looking at the score for 6 symptoms and can therefore have a minimum score of 0 or a maximum of 18.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.”|||scores on a scale||Standard Error|Least Squares Mean
1358402|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.|||Liters||Standard Deviation|Mean
1358403|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS). At each day/time point, only subjects with a value at both baseline and the respective day/time point are included. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.|||Liters||Standard Deviation|Mean
1358404|NCT01697696|Secondary|Change From Baseline in Mean Forced Expiratory Volume (Average of the Two FEV1 Measurements 45 and 15 Minutes Pre-dose) in One Second at Week 52|Change from baseline in pre-dose trough FEV1 was analyzed using a repeated measures analysis of covariance model which contained treatment, baseline FEV1, visit, baseline smoking status, baseline ICS use, COPD severity and treatment by visit, visit by baseline FEV1 interactions. An unstructured variance-covariance error matrix was used .Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose at Week 52. Baseline FEV1 was defined as the mean of the pre-dose FEV1 at -45 min and -15 min on Day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS) included patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
1358405|NCT01697696|Secondary|Time to Treatment Discontinuation|Discontinuation rates are calculated using the Kaplan Meier method. The protocol allowed patients to discontinue outside the treatment window, hence we have a patient who discontinued at Day 388. Reasons for discontinuing treatment are Subject/guardian decision, Adverse event, Protocol deviation Lack of efficacy, Physician decision, Dosing error, Disease improvement under study, Pregnancy, Technical problems|52 Weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
1358406|NCT01697696|Primary|Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis|||Percentage of participants|||Number
1358407|NCT01697592|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.|Baseline and Week 24|Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.|||Percent HbA1C||95% Confidence Interval|Least Squares Mean
1358478|NCT01697332|Primary|Differences Between Healthy and Diseased COPD Subjects.|Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.|4 years|No data analyzed or collected for this outcome measure.||||||
1358408|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.|||Percentage of participants|||Number
1358409|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of Participants|||Number
1358410|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.|||Percentage of participants|||Number
1358411|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).|Up to 24 weeks|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of participants|||Number
1358412|NCT01697579|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.|Up to 14 days postdose for each cycle (Cycles 2-6)|All randomized participants who received at least one dose of study treatment in Cycles 2-6.|||Percentage of participants|||Number
1358413|NCT01697579|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.|Up to 14 days postdose in Cycle 1|All randomized participants who received at least one dose of study treatment in Cycle 1.|||Percentage of participants|||Number
1358414|NCT01697579|Primary|CL/F of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
1358479|NCT01697332|Primary|Baseline Statistics of Healthy Subjects|Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.|4 years|No data collected or analyzed for this outcome measure.||||||
1358415|NCT01697579|Primary|C48hr of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 12 to 17 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.||||||
1358416|NCT01697579|Primary|C24hr of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358417|NCT01697579|Primary|t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358418|NCT01697579|Primary|AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358419|NCT01697579|Primary|AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358420|NCT01697579|Primary|Tmax of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358421|NCT01697579|Primary|Cmax of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358422|NCT01697579|Primary|CL/F of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
1358423|NCT01697579|Primary|C48hr of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 6 to <12 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358424|NCT01697579|Primary|C24hr of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358425|NCT01697579|Primary|t1/2 of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358426|NCT01697579|Primary|AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358427|NCT01697579|Primary|AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358428|NCT01697579|Primary|Tmax of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358429|NCT01697579|Primary|Cmax of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358430|NCT01697579|Primary|CL/F of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
1358431|NCT01697579|Primary|C48hr of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 2 to <6 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358432|NCT01697579|Primary|C24hr of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1362047|NCT01660191|Secondary|Changes in HDL and LDL Size|Change in levels will be measured by difference in levels at 12 weeks|Change from Baseline to 12 Weeks||||nanometre (nm)||Standard Deviation|Mean
1358433|NCT01697579|Primary|t1/2 of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358434|NCT01697579|Primary|AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358435|NCT01697579|Primary|AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358436|NCT01697579|Primary|Tmax of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358437|NCT01697579|Primary|Cmax of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358438|NCT01697579|Primary|Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
1358439|NCT01697579|Primary|Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 0 to <2 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358440|NCT01697579|Primary|Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358441|NCT01697579|Primary|Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358442|NCT01697579|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358443|NCT01697579|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
1358444|NCT01697579|Primary|Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
1358445|NCT01697579|Primary|Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
1358446|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS|||percentage of participants|||Number
1358447|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
1358448|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS|||percentage of participants|||Number
1358449|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
1358450|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT||EoT|FAS|||percentage of participants|||Number
1358451|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)||EoT, as defined in the predecessor study, was at Week 48 or Week 96|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
1358452|NCT01697501|Primary|Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF||EoF|FAS|||percentage of participants|||Number
1358453|NCT01697501|Primary|Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)||EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
1358454|NCT01697462|Secondary|Number of Participants With Hand-Foot Syndrome (HFS)|HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.|Baseline up to end of study (up to 42 months)|ITT population.|||Participants|||Number
1358455|NCT01697462|Secondary|Progression-Free Survival (PFS)|PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.|||Months||95% Confidence Interval|Median
1358456|NCT01697462|Secondary|Percentage of Participants With Disease Progression|Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.|||Percentage of participants|||Number
1358480|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Timed 25-Foot Walk Test (25FWT)|The timed 25-Foot Walk Test (25FWT) is an assessment of mobility and performance of leg function. The patient was instructed to walk a marked 25-foot course as quickly as possible in a time limit of 3 minutes and immediately walk back the same distance when reaching one end.The patient is allowed to use any ambulation method to move. The outcome measures the speed (feet / min) of moving.|Up to 96 weeks|Modified ITT Population|||% of change||Standard Deviation|Mean
1358457|NCT01697462|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.|Baseline up to end of study (up to 42 months)|Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.|||Participants|||Number
1358458|NCT01697449|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.|||months||95% Confidence Interval|Median
1358459|NCT01697449|Secondary|Percentage of Participants With Disease Progression or Death|Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.|||percentage of participants|||Number
1358460|NCT01697449|Secondary|Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline||Up to 65 months|Included participants whose CRC was identified as unresectable at baseline.|||percentage of participants|||Number
1358461|NCT01697449|Secondary|Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)|Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|All participants who received at least 1 dose of study drug were included in this analysis.|||percentage of participants|||Number
1358462|NCT01697449|Primary|Percentage of Participants With At Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 65 months|All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis.|||percentage of participants|||Number
1358463|NCT01697358|Other Pre-specified|Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups|This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.|6 months post randomization|As-treated - included all randomized subjects who provided data at 6-month visit, and analyzed based on the actual treatment the subjects received at 6-month visit.|||Participants|||Count of Participants
1358464|NCT01697358|Secondary|Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups|The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
1358476|NCT01697345|Primary|Total Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1358501|NCT01696981|Secondary|T3/T5 FSG Screening Result|Flexible sigmoidoscopy (FSG) result|T3 (three years after entry) or T5 (five years after entry)|All participants in the Colorectal Screening arm who had an FSG at T0 or T3 were analyzed.|||Participants|||Number
1358465|NCT01697358|Secondary|Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups|ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
1358466|NCT01697358|Secondary|Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups|Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
1358467|NCT01697358|Secondary|Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups|Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
1358468|NCT01697358|Primary|Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups|Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as non-responders.|||Participants|||Count of Participants
1358469|NCT01697345|Secondary|Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study||After 4 weeks||||participants|||Number
1358470|NCT01697345|Primary|FSFI Pain Domain|The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1358471|NCT01697345|Primary|FSFI Satisfaction Domain|The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1358472|NCT01697345|Primary|FSFI Orgasm Domain|The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1358473|NCT01697345|Primary|FSFI Lubrication Domain|The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1358474|NCT01697345|Primary|FSFI Arousal Domain|The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1358475|NCT01697345|Primary|FSFI Desire Domain|The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
1358502|NCT01696981|Secondary|T0 (Baseline) FSG Screening Results|Flexible sigmoidoscopy (FSG) result|T0 (at study entry)|All participants in the Colorectal Screening arm who had an FSG at T0 were analyzed.|||Participants|||Number
1358481|NCT01697319|Primary|Change From Baseline in Strength as Assessed by Grip and Pinch Test (GPT)|A grip-strength dynamometer and a pinch meter were used to measure grip strength and pinch strength. The results report change from baseline in strength for dominant and non-dominant hand in a forearm and wrist supported position.|Up to 96 weeks|Modified ITT Population|||kg||Standard Deviation|Mean
1358482|NCT01697319|Secondary|Percent Change From Baseline in Normalized Urine Keratan Sulfate (uKS)|Urinary keratan sulfate and urinary creatinine were measured through quantitative analysis. uKS is normalized to creatinine.|Up to 96 weeks|Modified ITT Population|||% of change||Standard Deviation|Mean
1358483|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Functional Dexterity Test (FDT)|FDT assesses the ability to use the hand in daily tasks. The test involves turning 16 wooden pegs over as quickly as possible on a hardwood pegboard with one hand requiring a three-jaw chuck prehension pattern between the fingers and thumb within a two-minute time limit. Hand function is evaluated by how fast a patient can turn over pegs in the given time limit, i.e. speed (number of pegs/minute).|Up to 96 weeks|Modified ITT Population|||% of change||Standard Deviation|Mean
1358484|NCT01696994|Secondary|T5 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T5 (five years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T5 were analyzed.|||Participants|||Number
1358485|NCT01696994|Secondary|T4 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T4 (four years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T4 were analyzed.|||Participants|||Number
1358486|NCT01696994|Primary|Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
1358487|NCT01696994|Secondary|T3 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T3 were analyzed.|||Participants|||Number
1358488|NCT01696994|Secondary|T3 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T3 were analyzed.|||Participants|||Number
1358489|NCT01696994|Secondary|T2 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T2 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T2 were analyzed.|||Participants|||Number
1358490|NCT01696994|Secondary|T2 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T2 (two years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T2 were analyzed.|||Participants|||Number
1358491|NCT01696994|Secondary|T1 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T1 were analyzed.|||Participants|||Number
1358492|NCT01696994|Secondary|T1 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T1 were analyzed.|||Participants|||Number
1358493|NCT01696994|Secondary|T0 (Baseline) TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T0 were analyzed.|||Participants|||Number
1358494|NCT01696994|Secondary|T0 (Baseline) CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T0 were analyzed.|||Participants|||Number
1358495|NCT01696994|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, she would be counted 3 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
1358496|NCT01696994|Secondary|Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).|Ovarian cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as ovarian cancer diagnoses divided by person years at risk for ovarian cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
1358497|NCT01696994|Secondary|Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1358498|NCT01696994|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
1358499|NCT01696994|Secondary|Deaths From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.||||Participants|||Number
1358500|NCT01696994|Primary|Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.||||Participants|||Number
1358503|NCT01696981|Primary|Colorectal Cancer Death Rates|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.||||Deaths per 10,000 PY|||Number
1358504|NCT01696981|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 2 positive screens with documented follow-up after each one, he would be counted 2 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
1358505|NCT01696981|Secondary|Colorectal Cancer Incidence Rates|Colorectal cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as colorectal cancer diagnoses divided by person years at risk for colorectal cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
1358506|NCT01696981|Secondary|Colorectal Cancer Incidence|Colorectal cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Participants|||Number
1358507|NCT01696981|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
1358508|NCT01696981|Secondary|Deaths From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Participants|||Number
1358509|NCT01696981|Primary|Colorectal Cancer Deaths|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.||||Participants|||Number
1358510|NCT01696968|Secondary|T3 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T3 (three years after entry)|All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.|||Participants|||Number
1358511|NCT01696968|Secondary|T2 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T2 (two years after entry)|All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.|||Participants|||Number
1358512|NCT01696968|Primary|Lung Cancer Death Rates|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.||||Deaths per 10,000 PY|||Number
1358513|NCT01696968|Secondary|T1 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T1 (one year after entry)|All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.|||Participants|||Number
1358514|NCT01696968|Secondary|T0 (Baseline) CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T0 (at study entry)|All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.|||Participants|||Number
1358515|NCT01696968|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of positive screens with complications.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
1358516|NCT01696968|Secondary|Lung Cancer Incidence Rates|Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
1358517|NCT01696968|Secondary|Lung Cancer Incidence|Lung cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1358518|NCT01696968|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
1358519|NCT01696968|Secondary|Deaths From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1358520|NCT01696968|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
1358521|NCT01696942|Secondary|Number of Participants With Endoscopic Recurrence of Crohn's Disease|To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.|One year following enrollment|Subjects available for colonoscopy at 12 month visit. This visit was sometimes separated from the overall 12-month visit so only 1 (cimzia) and 2 (mesalamine) patients respectively had the colonoscopy performed.|||Participants|||Count of Participants
1359717|NCT01682681|Primary|Percentage of Participants Retained to Topiramate Treatment|Participants with long term retention of topiramate until 52 weeks were reported|Week 52|The full analysis set (FAS) population included all participants who met all the eligibility criteria.|||Percentage of participants||95% Confidence Interval|Number
1358522|NCT01696942|Primary|Clinical Recurrence Rates of Crohn's Disease|To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn’s disease using the Crohn’s Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.|4 weeks, 3 months, 6 months, 9 months, and 12 months|Subjects who received CDAI questionnaire. Number of participants fluctuates due to withdrawals and missed appointments.|||Participants|||Count of Participants
1358523|NCT01696929|Secondary|Change in Total Psychotic Symptoms|The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology.|Change in PANSS total score from baseline to 8 weeks||||Change in PANSS Total Score||Standard Deviation|Mean
1358524|NCT01696929|Primary|Change in Cognition|The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108–115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline.|Change in BACS composite score from baseline to 8 weeks||||Change in BACS Composite Score||Standard Deviation|Mean
1358525|NCT01696773|Primary|Pharmacokinetics of Carotenoid Absorption|The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.|11 post-prandial blood samples will be taken over 12 hours||||nmol*h/L||Standard Error|Mean
1358526|NCT01696760|Secondary|Death Rate||Up to 3 months||||participants|||Number
1358527|NCT01696760|Secondary|Excessive Wound Drainage||Up to 3 months||||participants|||Number
1358528|NCT01696760|Secondary|Hematoma Formation||Up to 3 months||||participants|||Number
1358529|NCT01696760|Secondary|Readmission Rate to Hopsital||Up to 3 months||||participants|||Number
1358530|NCT01696760|Secondary|Development of Other Complications (Including Bleeding Complications)||Up to 3 months||||participants|||Number
1358531|NCT01696760|Secondary|Pulmonary Embolism Rate||Up to 3 months||||participants|||Number
1358532|NCT01696760|Primary|DVT Incident Rate|This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p < 0.05.|Up to 3 months||||participants|||Number
1358533|NCT01696695|Secondary|Percentage of Participants With Dose Modification of Capecitabine||Baseline up to 1254 days|ITT Population.|||Percentage of participants|||Number
1358534|NCT01696695|Secondary|Mean Duration of Capecitabine Therapy||Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.|||Days||Standard Deviation|Mean
1358535|NCT01696695|Secondary|Percentage of Participants Who Underwent Metastasectomy|Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.|Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1358536|NCT01696695|Secondary|Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1|Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population.|||Percentage of participants||95% Confidence Interval|Number
1358544|NCT01696643|Secondary|Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52|Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized.|Baseline, Weeks 49-52|All randomized participants who received at least 1 dose of study drug and had evaluable METDD data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||milligrams of METDD||Standard Deviation|Mean
1359718|NCT01682642|Secondary|Total Follicle Stimulating Hormone (FSH) Dose|total dose of FSH needed at the end of stimulation|3 weeks||||IUs||Standard Deviation|Mean
1358537|NCT01696695|Secondary|Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1|Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT population.|||Percentage of participants||95% Confidence Interval|Number
1358538|NCT01696695|Primary|PFS by Therapeutic Regimens|PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population. Here, number (n)= number of participants evaluable for the specified therapeutic regimen.|||Days||95% Confidence Interval|Median
1358539|NCT01696695|Primary|Median Progression-free Survival (PFS)|PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population|||Days||95% Confidence Interval|Median
1358540|NCT01696643|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, CV accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for the serious adverse events of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal (OW) events of interest included opioid withdrawal syndrome. The adverse events that indicated central OW included, but were not limited to, hyperhidrosis, tremor, dysphoria, and myalgia.~The number of participants with at least 1 confirmed CV, GI, or Central OW event is presented."|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||participants|||Number
1358541|NCT01696643|Secondary|Plasma Trough Concentrations of CB-5945|Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks.|Weeks 4, 12, 24, 36, and 52|All participants randomized to CB-5945 who received at least 1 dose of study drug and had evaluable CB-5945 concentration data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1358542|NCT01696643|Secondary|Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52|The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PCSA data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||units on a scale||Standard Deviation|Mean
1358543|NCT01696643|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52|The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PAC-QOL data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||units on a scale||Standard Deviation|Mean
1358578|NCT01696058|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as change from baseline. All p-values for these measures are only descriptive.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1359719|NCT01682642|Other Pre-specified|Number of Days of Stimulation|number of days needed before follicles in the ovary are mature for oocyte retrieval|3 weeks||||days||Standard Deviation|Mean
1358545|NCT01696643|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included “possibly related” or “related” as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||percentage of participants|||Number
1358546|NCT01696357|Primary|Average Number of Coughs Per Hour|The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.|7 days|One subject in the non-asthma group failed to return the device after the 7-trial. Data from 22 participants (3 from the asthma group, 19 from non-asthma group) were not included in the analysis as no data were recorded (due to a mechanical issue) or data were too extreme (due to cough algorithm failure).|||average number of coughs per hour||Standard Deviation|Mean
1358547|NCT01696214|Secondary|Physiologic Measures Were Determined at the Initial Visit, at Randomization Following a wash-in Period of 1 Month, Monthly for 24 Weeks and0 That a Follow-up Visit 1 Month Off Study Drug. Mean Scores Over the 24 Weeks of Treatment Were Compared.|Physiologic measures of FEV1, FVC and FEV1/FVC ratio|At each visit|||||||
1358548|NCT01696214|Secondary|The Asthma Symptom Utility Index(AUSI)|The Asthma Symptom Utility Index (AUSI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics.|Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatmen|||||||
1358549|NCT01696214|Primary|Asthma Control Test|The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.|Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatment were compared.||||units on a scale||Full Range|Median
1358550|NCT01696188|Secondary|Time for Block Placement|Calculate the time to perform the nerve block procedure.|immediately post-procedure||||seconds||95% Confidence Interval|Mean
1358551|NCT01696188|Secondary|Opioid Consumption|Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV|48 hours||||mg IV morphine equivalents||Inter-Quartile Range|Median
1358552|NCT01696188|Secondary|Catheter Dislodgements|Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.|24 hours||||participants|||Number
1358553|NCT01696188|Primary|Visual Analog Scale Pain Scores|Pain was rated from 0 (no pain) to 10 (worst pain imaginable)|24 hours||||units on a scale||Inter-Quartile Range|Median
1358554|NCT01696084|Secondary|Proportion of Subjects Receiving a Stem Cell Transplant|The number and percentage of subjects transferred for HSCT after induction treatment was recorded.|Post Induction|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||Participants|||Count of Participants
1358555|NCT01696084|Secondary|Rate of Achieving Morphologic Leukemia-free State|All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.|Day 14|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||Participants|||Count of Participants
1358556|NCT01696084|Secondary|Remission Duration|Only subjects achieving CR or CRi were assessed for remission duration.|From the date of achievement of a remission until the date of relapse or death from any cause|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||months||95% Confidence Interval|Median
1358557|NCT01696084|Secondary|Event-free Survival|All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.|From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||months||95% Confidence Interval|Median
1358558|NCT01696084|Secondary|Proportion of Subjects With a Response|Complete Remission (CR)|Post Induction|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||Participants|||Count of Participants
1358559|NCT01696084|Primary|Overall Survival|Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.|From the date of randomization to death from any cause|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||months||95% Confidence Interval|Median
1358590|NCT01695772|Secondary|Disease Free Survival (DFS)|Disease Free Survival (DFS) was defined as the time from complete resection of liver metastases to disease relapse or death, for participants who achieve complete resection after pre-operative treatment with standard 5-FU based doublet regimen plus bevacizumab.|Complete resection date up to disease relapse or death until data cutoff on 12 May 2016 (up to approximately 3.5 years)|ITT population; Here, number of participants analyzed = participants who underwent study specified surgery. Participants who underwent surgery but did not achieve complete resection were censored.|||months||95% Confidence Interval|Median
1358560|NCT01696071|Secondary|Peak Expiratory Flow (PEF) AUC0-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres per minute.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres/min||Standard Error|Least Squares Mean
1358561|NCT01696071|Secondary|Trough FVC Responses|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FVC was defined as the FVC value just prior to the last evening dose of study medication.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358562|NCT01696071|Secondary|Peak FVC Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FVC was defined as the highest FVC reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FVC Peak0-24h).|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358563|NCT01696071|Secondary|FVC AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358564|NCT01696071|Secondary|FVC AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358565|NCT01696071|Secondary|Forced Vital Capacity (FVC) AUC0-24h Response|"MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.~The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358566|NCT01696071|Secondary|Trough FEV1 (L) Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FEV1 was defined as the FEV1 value just prior to the last evening dose of study medication.|10 minutes (min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358567|NCT01696071|Secondary|Peak FEV1 Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FEV1 was defined as the highest FEV1 reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FEV1 Peak0-24h). The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively.|10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks.|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358591|NCT01695772|Secondary|Number of Participants With Disease Relapse or Death||Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||participants|||Number
1359720|NCT01682642|Secondary|Number of Cryopreserved Embryos|number of blastocytes that can be cryopreserved|1 week after oocyte retrieval||||number of cryopreserved embryos||Standard Deviation|Mean
1358568|NCT01696071|Secondary|FEV1 AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358569|NCT01696071|Secondary|FEV1 AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
1358570|NCT01696071|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response.|"Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.~The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Liters||Standard Error|Least Squares Mean
1358571|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|"Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||number of puffs||Standard Error|Least Squares Mean
1358572|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|"Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||number of puffs||Standard Error|Least Squares Mean
1358573|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|"Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol metered dose inhaler (MDI) (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||usage (total daily) number of puffs||Standard Error|Least Squares Mean
1358574|NCT01696058|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|"Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
1358575|NCT01696058|Secondary|Trough FVC Response at 12 Weeks; Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||L||Standard Error|Least Squares Mean
1358576|NCT01696058|Secondary|Peak FVC Response at 12 Weeks; Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1358577|NCT01696058|Secondary|FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline. AUC was standardized by dividing by time unit.|baseline and 12 Weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1358579|NCT01696058|Secondary|Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data|The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores [dichotomous (true/false) except last question (4-point Likert scale)]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate – study – will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.|12 weeks|FAS with last observation carried forward (LOCF) imputation (combined data from twin studies 1222.51 and 1222.52). Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039).|||units on a scale (total score)||Standard Error|Least Squares Mean
1358580|NCT01696058|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1358581|NCT01696058|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables|||Area Under the Curve (L) (standardized)||Standard Error|Least Squares Mean
1358582|NCT01696045|Secondary|Overall Survival Time|Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date).|From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)|All treated participants|||months||95% Confidence Interval|Median
1358583|NCT01696045|Secondary|Best Overall Response Rate (BORR)|"Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage.~CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s)."|From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)|All treated participants|||percentage of participants||95% Confidence Interval|Number
1358584|NCT01696045|Secondary|Progression Free Survival|Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment.|From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)|All treated participants|||months||95% Confidence Interval|Median
1358585|NCT01696045|Secondary|Disease Control Rate (DCR)|"Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria.~CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s)."|From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
1358586|NCT01696045|Primary|Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)|The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.|From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)|All treated participants|||percentage of participants||95% Confidence Interval|Number
1358587|NCT01696045|Primary|Overall Survival (OS) Rate at 1 Year|Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.|1 year following start of treatment (Assessed up to June 2016, approximately 38 months)|All treated participants|||percentage of participants||95% Confidence Interval|Number
1358588|NCT01695993|Primary|Patient Report Nausea Diary|"Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = Not at all nauseated and at the other end by 7 = Extremely nauseated. The outcome variable for the primary analysis was greatest reported nausea from the five day period."|five days||||units on a scale||Standard Deviation|Mean
1358589|NCT01695772|Secondary|Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12||Months 3, 6, 9, and 12|ITT population|||PP of being alive and disease free||95% Confidence Interval|Median
1358592|NCT01695772|Secondary|Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. The probability was estimated by Kaplan Meier curve analysis.|Months 3, 6, 9, 12, 15, and 18|ITT population; Number of participants analyzed equals (=) number of participants who had surgery.|||PP of being alive and progression free||95% Confidence Interval|Number
1358593|NCT01695772|Secondary|Progression Free Survival (PFS)|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. Kaplan-Meier curves were used to display PFS.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||months||95% Confidence Interval|Median
1358594|NCT01695772|Secondary|Number of Participants With Disease Progression or Relapse or Death|According to RECIST v1.1 Progressive Disease is defined as a 20 % or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||participants|||Number
1358595|NCT01695772|Secondary|Percentage of Participants Achieving Objective Response|Objective response rate was defined as the percentage of participants who achieved either Partial Response (PR) or Complete Response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1. This is defined as the best response recorded from the start of trial treatment until disease progression (or death). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [≥] 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||percentage of participants||95% Confidence Interval|Number
1358596|NCT01695772|Secondary|Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection)|R1 resection was defined as achievement of incomplete tumor resection with microscopic involvement of a margin after pre-operative chemotherapy plus bevacizumab, as confirmed by pathology. Participants with R1 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population|||percentage of participants||95% Confidence Interval|Number
1358597|NCT01695772|Primary|Percentage of Participants Achieving Complete Resection (R0 Resection)|R0 resection was defined as complete resection confirmed by pathology after pre-operative chemotherapy plus bevacizumab. Participants with R0 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population|||percentage of participants||95% Confidence Interval|Number
1358598|NCT01695746|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 24|The safety population was defined as all participants entered into the study.|||Participants|||Number
1358599|NCT01695746|Secondary|Number of Participants Who Received Concomitant Treatment for Anemia|Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.|Up to Week 24|The safety population included all participants entered into the study.|||Participants|||Number
1358600|NCT01695746|Primary|Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value|Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.|Up to Week 24|The ITT population was the anticipated population for analysis.||||||
1358601|NCT01695746|Primary|Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)|Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time – visit date of first dosing) + 1.|Up to Week 24|The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.|||Weeks||Standard Deviation|Mean
1358602|NCT01695746|Primary|Number of Participants With Co-morbidities at Baseline (Week 0)|Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.|||Participants|||Number
1358603|NCT01695746|Secondary|Number of Doses of C.E.R.A. Administered by Different Routes|The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.|Up to Week 24|The safety population included all participants entered into the study.|||Doses|||Number
1358604|NCT01695746|Secondary|Mean Dose of C.E.R.A. Administered|The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.|Up to Week 24|The safety population included all participants entered into the study.|||mcg per month||Standard Deviation|Mean
1358605|NCT01695746|Secondary|Mean Time Spent in the Hemoglobin Target Range (10 – 12 Gram/Deciliter)|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 – 12 g/dL) is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.|||Weeks||Standard Deviation|Mean
1358606|NCT01695746|Secondary|Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study|Correction of anemia was evaluated in participants with Hb < 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation.|||Percentage of participants|||Number
1358607|NCT01695746|Primary|Mean Weight of Participants at Baseline (Week 0)|The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.|||kg||Standard Deviation|Mean
1358608|NCT01695746|Primary|Mean Height of Participants at Baseline (Week 0)|The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.|||cm||Standard Deviation|Mean
1358609|NCT01695668|Primary|Progression of Dry Eye Severity|Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.|1 year||||patients with increased dry eye severity|||Number
1358610|NCT01695369|Primary|Subjective Responses for Comfort Rated on a 0-100 Visual Scale.|Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)|Baseline Insertion, 10 Minutes, 5 hours and 10 hours||||units on a scale||Standard Deviation|Mean
1358611|NCT01695330|Secondary|Compare Overall Response Rate (CR + VGPR + PR + MR), Compare Disease Parameters, & Determine Incidence and Severity of Injection-site Reactions.|Compare overall response rate [combined CR + very good partial response (VGPR) + PR + MR] and disease parameters [time to progression, -progression free survival, -time to first response, -duration of response, -overall survival] following treatment with a SC bortezomib-containing combination regimen for MM patients who have demonstrated progressive disease form a prior or different IV bortezomib-containing combination regimen. Determine incidence and severity of injection-site reactions with CS administration of bortezomib by number of patients with injection site reaction specific adverse events.|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.||2017-10-31|10/2017||||
1358612|NCT01695330|Primary|The Primary Objective of This Study Will be to Investigate the Incidence and Severity of Peripheral Neuropathy Caused by a Prior Intravenous VELCADE-containing Regimen in Comparison to That Caused by a Subcutaneous VELCADE-containing Regimen.|"Definition of incidence: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit.~Definition of severity: the severity of any treatment-emergent peripheral neuropathy experienced by a patient on-study. Peripheral neuropathy severity is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as the End of Study visit and is graded on a 0-4 scale based on CTCAE criteria.~Incidence of Peripheral Neuropathy Definition: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit."|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.||||Participants|||Count of Participants
1358613|NCT01695304|Primary|Health Facility Visits for Diarrheal Disease|incidence rate of health facility visits for diarrheal disease per 100 person-week of observation|6 months|incidence rate of health facility visits for diarrheal disease per 100 person-week of observation|||incidence rate per 100 person-weeks|||Number
1358614|NCT01695304|Primary|Longitudinal Diarrhea Prevalence|The primary outcome measure is the longitudinal prevalence of diarrheal disease.|6 months|Incidence rate per 100 person-weeks of observation|||Incidence rate per 100 person-weeks|||Number
1358615|NCT01695239|Secondary|Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)|Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.|Baseline to Week 24|All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and postbaseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.|||participants|||Number
1358616|NCT01695239|Secondary|Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score.|||units on a scale||Standard Error|Least Squares Mean
1358617|NCT01695239|Secondary|Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)|The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.|||units on a scale||Standard Error|Least Squares Mean
1358618|NCT01695239|Secondary|Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.|||units on a scale||Standard Error|Least Squares Mean
1358619|NCT01695239|Secondary|Percent Change From Baseline in Body Surface Area (BSA)|The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant’s handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.|||percent change in BSA||Standard Error|Least Squares Mean
1358620|NCT01695239|Secondary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline|The sPGA is the physician’s determination of the severity of the participant’s psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.|Week 24|All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
1358621|NCT01695239|Secondary|Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)|The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
1358622|NCT01695239|Secondary|Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease|The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant’s Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.|Baseline, Week 24|All randomized participants who had baseline and post baseline DAS28-CRP data.|||units on a scale||Standard Error|Least Squares Mean
1358630|NCT01695239|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])|The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline mTSS data.|||units on a scale||Standard Error|Least Squares Mean
1358623|NCT01695239|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])|The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline QIDS-SR16 data.|||units on a scale||Standard Error|Least Squares Mean
1358624|NCT01695239|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.|||units on a scale||Standard Error|Least Squares Mean
1358625|NCT01695239|Secondary|Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)|JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.|Baseline, Week 24|All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.|||units on a scale||Standard Error|Least Squares Mean
1358626|NCT01695239|Secondary|Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no fatigue” and 10 representing “as bad as you can imagine.” Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline fatigue NRS data.|||units on a scale||Standard Error|Least Squares Mean
1358627|NCT01695239|Secondary|Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 12|All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.|||units on a scale||Standard Error|Least Squares Mean
1358628|NCT01695239|Secondary|Change From Baseline in Leeds Enthesitis Index (LEI)|The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 12|All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.|||units on a scale||Standard Error|Least Squares Mean
1358629|NCT01695239|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)|The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
1358640|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
1358631|NCT01695239|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant’s self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline HAQ-DI data.|||units on a scale||Standard Error|Least Squares Mean
1358632|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score at Week 24|ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
1358633|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24|ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
1358634|NCT01695239|Secondary|Percentage of Participants Achieving ACR20 Response at Week 12|ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 12|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
1358635|NCT01695239|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).|Week 24|All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
1358636|NCT01695044|Primary|Overall Radiologic Response|Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject’s best response assignment depended on the achievement of both measurement and confirmation criteria.|24 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The full modified Intention-to-Treat (mITT) population (n = 119) was examined.|||% of subjects|||Number
1358637|NCT01695044|Primary|CTC Response|Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.|24 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.|||% of responders|||Number
1358638|NCT01695044|Primary|Percentage of Participants With Total Serum PSA Response|Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.|24 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.|||% of responders|||Number
1358639|NCT01694966|Primary|To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.|Adenoma Detection Rate|+7 days|FAS|||percentage of participants|||Number
1358654|NCT01694667|Secondary|Change in Social Responsiveness Scale (SRS) Score|Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.|Baseline, Week 6|||||||
1358641|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
1358642|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||usage (total daily) number of puffs||Standard Error|Least Squares Mean
1358643|NCT01694771|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
1358644|NCT01694771|Secondary|Peak FVC Response at 12 Weeks - Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1358645|NCT01694771|Secondary|Trough FVC Response at 12 Weeks- Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||L||Standard Error|Least Squares Mean
1358646|NCT01694771|Secondary|FVC AUC0-3h Response at 12 Weeks - Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1358647|NCT01694771|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1358648|NCT01694771|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
1358649|NCT01694771|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables|||Area Under the Curve (L)||Standard Error|Least Squares Mean
1358650|NCT01694706|Secondary|Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1358651|NCT01694706|Primary|Faldaprevir: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the faldaprevir in plasma~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1358652|NCT01694706|Primary|Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|Pharmacokinetic (PK) set: Included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.|||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
1358653|NCT01694667|Secondary|Change in Clinical Global Impression - Improvement (CGI-I) Score|"Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who responded in each group is the number where the parents reported that their child was improved, much improved, or very much improved."|Baseline, Week 6||||# parents reporting improvement|||Number
1359721|NCT01682642|Secondary|Number of Pro Nuclear Cell (2PN)|number of 2PN|1 day after oocyte retrieval||||number of pro nuclear cells||Standard Deviation|Mean
1358655|NCT01694667|Secondary|Aberrant Behavior Checklist - Inappropriate Speech Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1358656|NCT01694667|Secondary|Aberrant Behavior Checklist - Irritability Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1358657|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Stereotypy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1358658|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Lethargy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
1358659|NCT01694667|Primary|Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48."|Baseline, 6 weeks (3 week value to be collected)||||units on a scale||Standard Deviation|Mean
1358660|NCT01694641|Other Pre-specified|Perinatal Outcome|gestational age at delivery, birth weight,|perinatal outcome assessed after delivery|||||||
1358661|NCT01694641|Other Pre-specified|Time Lapse Score|a score based on 8 observations by time lapse monitoring|the time lapse score is assessed on the day of embryo transfer (day 5 after the egg retrieval)|||||||
1358662|NCT01694641|Secondary|Live Birth|live birth after 24 weeks gestation|delivery after 24 weeks|All patients randomzed regardless whether completed the study or not according to their assignment (intention to treat population).|||Participants|||Count of Participants
1358663|NCT01694641|Primary|Pregnancy Rate|rise in beta HCG 12-14 days after transfer|12-14 days after transfer|All patients randomized are analyszs (intention to treat analysis).|||Participants|||Count of Participants
1358664|NCT01694420|Other Pre-specified|Number of Participants With Adverse Events Related to Study Drug||48 weeks||||participants|||Number
1358665|NCT01694420|Other Pre-specified|Number of Participants With Grade 3 or Grade 4 Adverse Events||48 weeks||||participants|||Number
1358666|NCT01694420|Secondary|Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF||48 weeks||||days||Full Range|Median
1358667|NCT01694420|Secondary|Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+||48 weeks|Data not collected||||||
1358668|NCT01694420|Primary|Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48||48 weeks||||participants|||Number
1358669|NCT01694420|Primary|Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24||24 weeks||||participants|||Number
1358670|NCT01694199|Secondary|Time to First Use of Supplemental Analgesic Medication|The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.|Treatment with the test device twice per day, over 3 days (7 total treatments)||||Minutes||95% Confidence Interval|Median
1358671|NCT01694199|Secondary|Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent|Number of participants who assessed pain control at 72 hours as good, very good, or excellent.|After 3 days of treatment (T0-72 hours)||||Participants|||Count of Participants
1358672|NCT01694199|Secondary|Opioid Consumption Measured in Morphine Equivalents T0-72 Hours|The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.|Treatment with the test device twice per day, over 3 days (7 total treatments)||||Morphine Equivalents||95% Confidence Interval|Median
1358673|NCT01694199|Secondary|TOTPAR-Pain Relief Experienced by Patients T0-72 Hours|"Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i)."|Treatment with the test device twice per day, over 3 days (7 total treatments)||||units on a scale||95% Confidence Interval|Geometric Mean
1359868|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured 24 hours post-operatively|24 hours post procedure|Only patients for whom 24 hour CK-MB values were available were analyzed|||ng/mL||Standard Deviation|Mean
1358674|NCT01694199|Primary|Overall Analgesic Efficacy (Via SPID 0-72 Hrs)|Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.|Treatment with the test device twice per day, over 3 days (7 total treatments)|P=0.3529|||units on a scale||95% Confidence Interval|Median
1358675|NCT01694108|Other Pre-specified|Quality of Communication and Information|"To test that the use of telephone and internet was acceptable in the study population using the Quality of Informed Consent (QuIC) questionnaire. The questionnaire was divided into six categories; five on study comprehension and one on satisfaction with the information process. The items in the first five categories could be answered with yes, no or do not know. The last category was rated on a 7-point Likert scale, with 1 being “very dissatisfied” and 7 being “very satisfied”. The primary outcome was the sum of the score for comprehension items and satisfaction items. Comprehension items were scored 1 point for each correct answer and 0 points for each incorrect answer. Satisfaction items were scored as rated on the 7-point Likert scale. Total score ranged from 7 to 69 points, comprehension score from 0 to 20 points and satisfaction score from 7 to 49 points. The higher score, the better comprehension and satisfaction."|2 days after the information was given|This is a small, separate sub-study. 59 + 59 participants had sufficient follow-up data to participate in the analysis.|||Score on QuIC scale||Inter-Quartile Range|Mean
1358676|NCT01694108|Other Pre-specified|Decisional Conflict Scale Score|After parents having made the decision about whether to accept vaccination of their newborn through participation in The Danish Calmette Study, O’Connor’s Decisional Conflict Scale was used to identify decisional conflicts. The score ranges from 0 (no decisional conflict) til 100 (maximum decisional conflict). Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation; so a low score reflects a low level of doubt about the decision about participation/decline participation in the trial, and a high score reflects a high level of doubt.|The decisional conflict score was measured before randomisation|This outcome was a sub-study to The Danish Calmette Study with 667 participating mothers and 320 declining mothers.|||decisional conflict score||Inter-Quartile Range|Mean
1358677|NCT01694108|Secondary|Number of Events of Febrile Convulsions|To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
1358678|NCT01694108|Secondary|Number of Events of Acute Otitis Media|To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
1358679|NCT01694108|Secondary|Number of Events With Diarrhoea and Vomiting|To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
1358680|NCT01694108|Secondary|Number of Events of Febrile Episodes|To test that Danish infants who get the BCG vaccine at birth get less febrile episodes at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
1358681|NCT01694108|Secondary|Number of Events of Pneumonia|To test that Danish infants who get the BCG vaccine at birth get less pneumonia at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
1358682|NCT01694108|Secondary|Number of Events of Common Cold|To test that Danish infants who get the BCG vaccine at birth experience less events of common cold until 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
1358683|NCT01694108|Secondary|Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL|To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.|13 months of age|This outcome was a sub-study with 158 participants. Antibody concentration (AC) of > 0.1 IU/mL was considered protective|||participants|||Number
1358684|NCT01694108|Secondary|Interferon Gamma Response|To test that infants who receive the BCG at birth respond in interferon-gamma response upon stimulation with BCG. The interferon gamma response was defined as a value above the cut-off value of 107 pg/ml.|13 months of age|This is a sub study using bloodsamples. Only a small sub population from the overall trial participated.|||participants|||Number
1358685|NCT01694108|Secondary|Monocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in monocyte count measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.|||Cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
1358686|NCT01694108|Secondary|Leucocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in leucocyte count (white blood cell count) measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.|||cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
1376139|NCT01496274|Secondary|Number of Subjects Developing Antibodies Against rIX-FP||For the duration of the study; median 20.27 months.|Safety Population|||participants|||Number
1358687|NCT01694108|Secondary|Thymic Gland Size at 3 Months of Age|To test that infants who receive the BCG at birth respond in thymic gland size defined by ultra sound examination. First, the thymus gland was identified in a horizontal scanning plane and the largest transverse diameter of the thymus was obtained. Second, in a sagittal scanning plane, the area of the largest lobe was assessed. Both measurements were obtained twice, and in case of more than 15% difference, both measurements were repeated. The mean of the two measurements were multiplied and defined as the thymic index.|3 months of age|This outcome was a sub-study to The Danish Calmette Study with 301 (BCG 153, Control 148) participating children.|||Thymic index||95% Confidence Interval|Mean
1358688|NCT01694108|Secondary|Standardized Head Circumference at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in head circumference. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Head circumference z-score||Standard Deviation|Mean
1358689|NCT01694108|Secondary|Length at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in length. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Length z-score||Standard Deviation|Mean
1358690|NCT01694108|Secondary|Food Allergy|Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.|||participants|||Number
1358691|NCT01694108|Secondary|Episodic Viral Wheeze|Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview.|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.|||participants|||Number
1358692|NCT01694108|Secondary|Standardized Weight, Length and Head Circumference of Premature Children at 13 Months|The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|Premature children born with gestational age 32-36 weeks. This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.|||z-score||Standard Deviation|Mean
1358693|NCT01694108|Secondary|DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age|To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.|13 months of age|Per-protocol analysis excluding 11 children randomised to BCG who did not receive the vaccine, and 36 children randomised to control who received the BCG vaccine.|||participants|||Number
1358694|NCT01694108|Secondary|Psychomotor Development in Premature Infants|To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: ASQ: Ages and stages questionnaire – a parent reported questionnaire that measures child psychomotor development. Total range of ASQ score: 0 to 300 points. Higher scores indicate higher level of psychomotor development.|13 months of age|This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.|||Score on ASQ scale||Standard Deviation|Mean
1358695|NCT01694108|Secondary|Standardized Weight at 13 Months|To test that infants who get the BCG vaccine at birth respond in weight.The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|This analysis only includes children with available follow-up data from telephone interviews or clinical examinations. As opposed to the primary outcome, follow-up was lower than 100%.|||Weight z-score at 13 months||Standard Deviation|Mean
1358696|NCT01694108|Secondary|Specific IgE|Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35.|13 months of age|This analysis includes children who participated with blood samples for this sub-study regarding specific IgE.|||participants|||Number
1358697|NCT01694108|Secondary|Atopic Dermatitis|"To test if BCG vaccination within 7 days after birth influence the risk of atopic dermatitis defined by clinical examination at 13 months of age using scoring atopic dermatitis (SCORAD) or by parental report of physician diagnosed atopic dermatitis in the telephone interview at 13 months of age."|13 months of age|This analysis includes children with follow-up data from clinical examination or telephone interview. As opposed to the register-based primary outcome, adherence to telephone-interview and clinical examination was slightly lower than 100%.|||participants|||Number
1358698|NCT01694108|Secondary|Antibiotics|To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. Use of antibiotics was defined as one or more precriptions of systemic antibiotics (ATC groups J01, J02, J05, all subgroups inclusive).|0-15 months of age|Intention-to-treat|||participants|||Number
1358699|NCT01694108|Primary|All-cause Hospitalisations|To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants.|0-15 months of age|Intention-to-treat|||Events|||Number
1379749|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)|||||||
1358700|NCT01693900|Secondary|Patient Satisfaction With Postoperative Pain Control|Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.|At the 3 week post-op visit|Data was obtained for the 25 patients in the pre-operative group and 22 patients in the intra-operative group who responded to 3-week followup phone calls.|||units on a scale||Standard Deviation|Mean
1358701|NCT01693900|Secondary|Incidence of Adverse Events|Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.|From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.|Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.|||Participants|||Count of Participants
1358702|NCT01693900|Primary|Postoperative Pain During Recovery|Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.|From discharge from PACU until discharge from hospital, an average of 2-3 days|Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group|||units on a scale||Inter-Quartile Range|Median
1358703|NCT01693900|Primary|Postoperative Pain During PACU Admission|"Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:~Baseline assessment in Preoperative area~Upon arrival to the post-anesthesia care unit (PACU)~Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge All pain scores per subject from the time of PACU admission until discharge from PACU will be averaged to obtain one data point per subject."|From time of PACU admission until discharge from PACU, an average of 2 hours|Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.|||units on a scale||Inter-Quartile Range|Median
1358704|NCT01693653|Secondary|Safety|The study was terminated. No data were collected for this outcome measure.|9 moths|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358705|NCT01693653|Secondary|BDCAF|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358706|NCT01693653|Secondary|MDHAQ|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358707|NCT01693653|Secondary|BSAS|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358708|NCT01693653|Secondary|Gential Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358709|NCT01693653|Secondary|Oral Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358710|NCT01693653|Secondary|Treatment Failures|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358711|NCT01693653|Secondary|Oral Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358712|NCT01693653|Secondary|Genital Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
1358713|NCT01693653|Primary|Primary Outcome|The study was terminated. No data were collected for this Outcome Measure.|9 months|The study was terminated. No data were collected for this Outcome Measure.||||||
1358714|NCT01693484|Primary|Perfusion Data Infection Wound Healing Complication|correlation of multiple absolute and relative data points acquired from near infra red spectroscopy compared to clinical postoperative infection or wound healing complication following lateral approach calcaneus fracture|3 months postoperative|unable to complete analysis as correlation between clinical and ICG near infra red data acquisition could not be completed do to unexpected lack funding required to pair and analyze extremely large data sets with clinical information as well as too few numbers of patients||||||
1358715|NCT01693367|Secondary|WOMAC|To assess pain, stiffness, and physical function|Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
1358716|NCT01693367|Secondary|Full Weight-bearing Status|"Assessment of the timepoint when the patient :~can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds~can walk without walking aid~has no intake of analgesics~has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable"|weekly measurement at home|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
1358717|NCT01693367|Secondary|Range of Motion (ROM)|Assessment of passive ROM of the knee (flexion – extension)|6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
1358718|NCT01693367|Secondary|Quality of Life (EuroQol-5D)||Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
1358719|NCT01693367|Secondary|Timed Up-and-go Test (TUG)|"The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command ready - go and stopped when the seated position is reached again."|12 weeks ± 7 days, 6 months ± 30 days|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
1358720|NCT01693367|Primary|Western Ontario and McMaster Universities Index (WOMAC)|To assess pain, stiffness, and physical function|12 months after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
1358721|NCT01693185|Secondary|Indigence of Patient's Recall|The numbers of patients who recalled instructions and explanations given during colonoscopy|after colonoscopy||||participants|||Number
1358722|NCT01693185|Secondary|Endoscopist Satisfaction|endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm|5 min after the colonoscopy||||units on a scale||Inter-Quartile Range|Median
1358723|NCT01693185|Secondary|Patient's Distress Score|patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100|5 min after the end of colonoscopy||||units on a scale||Inter-Quartile Range|Median
1358724|NCT01693185|Secondary|Bispectra Lindex Score|Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100|every 5 min during and after colonoscopy||||units on a scale||Full Range|Median
1358725|NCT01693185|Secondary|Participants Assumed to Feel Frequent Pain|"patients sound Ah at feeling pain during colonosocpy: if a patients sounds Ah > 6 times, the patient was assumed to feel frequent pain."|during and after colonoscopy||||participants|||Number
1358726|NCT01693185|Primary|The Recovery Time|"Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit~Aldrete score~Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0~O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0~Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0~Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0~Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0~To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and –R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference."|every 5 minutes after completing colonoscopy up to 30 min||||minute||Inter-Quartile Range|Median
1358727|NCT01693120|Secondary|Number of Participants With Pulmonary Vein Stenosis|Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure|3 months|Number of subjects selected for participation in the pulmonary vein assessment cohort with baseline and 3-month evaluable magnetic resonance imaging scans of the pulmonary veins|||Participants|||Count of Participants
1358728|NCT01693120|Secondary|Number of Participants With Acute Procedural Success|Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion)|30 minutes|All subjects who underwent a Phased RF study procedure|||Participants|||Count of Participants
1358729|NCT01693120|Secondary|6-month Post-procedure Effectiveness|For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG|6 months|Of the 129 subjects with an index Phased RF ablation procedure, 114 were evaluable for the 6-month efficacy objective. There were 15 subjects that were not included in the 6-month efficacy objective; 13 due to study exit prior to the 6-month visit and 2 due to no 6-month ambulatory ECG|||Participants|||Count of Participants
1358730|NCT01693120|Primary|Number of Participants With Procedure and/or Device Related Stroke|A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee|30 days|All subjects with a Phased RF ablation procedure who did not have a non-investigational catheter placed in the left atrium|||Participants|||Count of Participants
1358731|NCT01693068|Secondary|Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings|Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.|Baseline up to cut-off date (04-Jul-2015)|Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.|||subjects|||Number
1358749|NCT01692782|Secondary|Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.|The WRAADDS measured the severity of the target symptoms of adults with ADHD. It measured symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) and summarized each of the 7 categories on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = quite a bit, 4 = very much). The WRAADDS total score is defined as sum of all 28 item subscores (range 0 - 56).|Weeks 1, 2, 3, 4|Intent to treat|||units on a scale||Standard Error|Least Squares Mean
1358732|NCT01693068|Secondary|Number of Subjects With Adverse Events (AEs) of Special Interest|Adverse events of special interest included ocular retinal vein occlusion, serious retinal detachment or similar retinal abnormality characterized by accumulation of serous fluid in the retina, creatine phosphokinase (CPK) elevation and isoenzyme TEAE of Special Interest (Grade >=2) and acute renal failure (Grade >=2). Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.|Baseline up to cut-off date (04-Jul-2015)|Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.|||subjects|||Number
1358733|NCT01693068|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs. TEAEs were to be reported separately for dacarbazine, pimasertib and pimasertib (crossover) reporting arms.|Baseline up to cut-off date (04-Jul-2015)|Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.|||subjects|||Number
1358734|NCT01693068|Secondary|Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)|QoL assessed using FACT-M assessment tool. This includes 27-item FACT-G questionnaire which consists of 24 questions; 7 relating to PWB, 7 relating to SWB, 6 relating to EWB and 7 relating to FWB. Also, it includes melanoma-specific subscale consists of 16 questions for MS and 8 questions for the MSS. Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Trial Outcome Index (FACT-M TOI) ranges from 0 to a high of 120 and is derived as: FACT-M TOI = PWB Score + FWB Score +MS Score. Higher scores represent a better quality of life.|Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])|ITT analysis set. Here “Number of Subjects Analyzed” = subjects evaluable for this outcome and “Number Analyzed” = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.|||units on a scale||Standard Deviation|Mean
1358735|NCT01693068|Secondary|Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)|QoL assessed using Function Assessment Cancer Therapy-melanoma (FACT-M) assessment tool. This includes 27-item FACT-General (FACT-G) questionnaire which consists of 24 questions;7 relating to physical well-being (PWB),7 relating to social/family well-being (SWB),6 relating to emotional well-being (EWB) and 7 relating to functional well-being (FWB). Also, it includes melanoma-specific subscale consists of 16 questions for Melanoma Subscale (MS) and 8 questions for Melanoma Surgery Scale (MSS).Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172 and is derived as follows: FACT-M TS= PWB Score + SWB Score + EWB Score + FWB Score + MS Score. Higher scores represent a better quality of life.|Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])|ITT analysis set. Here “Number of Subjects Analyzed” = subjects evaluable for this outcome and “Number Analyzed” = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.|||units on a scale||Standard Deviation|Mean
1358736|NCT01693068|Secondary|Percentage of Subjects With Overall Survival (OS) at 12 Months|OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date. Percentage of Subjects with OS at 12 months were reported.|12 months|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1358737|NCT01693068|Secondary|Overall Survival (OS)|OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date.|From date of randomization until date of death from any cause, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1358738|NCT01693068|Secondary|Percentage of Subjects With Progression-free Survival (PFS) at 6 Months|PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of Subjects with PFS at 6 Months were reported.|6 months|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1359869|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured pre-operatively|pre-operative|Only patients for whom preoperative CK-MB levels were available were analyzed|||ng/mL||Standard Deviation|Mean
1358739|NCT01693068|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of subjects with CR, PR, or stable disease (SD) for greater than (>) 3 months assessed by investigator according to RECIST version 1.1. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1358740|NCT01693068|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of subjects with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
1358741|NCT01693068|Primary|Progression Free Survival (PFS)|PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||weeks||95% Confidence Interval|Median
1358742|NCT01693029|Secondary|Incidence of Antibody Formation Against Epoetin|Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.|52 weeks|All patients treated with study drug with a post-baseline antibody assessment|||Participants|||Count of Participants
1358743|NCT01693029|Secondary|Mean Weekly Dose During Evaluation Period (Week 21-28)|Mean weekly study drug dose during evaluation period (Week 21-28)|Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.|||international units||Standard Deviation|Mean
1358744|NCT01693029|Primary|Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)|Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .|Week -4 to Day1 and Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.|||g/dL||Standard Deviation|Mean
1358745|NCT01693029|Primary|Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)|Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .|Week -4 to Day1 and Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.|||g/dL||Standard Error|Least Squares Mean
1358746|NCT01692951|Primary|Compare Concentration of Fatty Acids and Their Metabolites|Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.|At the time of diagnosis, prior to the initiation of lung cancer treatment||||mg/mL||Inter-Quartile Range|Median
1358747|NCT01692938|Primary|Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.|1 Month||||decibels||Standard Deviation|Mean
1358748|NCT01692938|Primary|Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.|1 Month||||decibels||Standard Deviation|Mean
1358751|NCT01692782|Secondary|Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The even number items (2, 4, 6, 8, 10, 12, 14, 16, 18) assess hyperactive impulsive symptoms and the odd number items (1, 3, 5, 7, 9, 11, 13, 15, 17) assess inattentive symptoms. The ADHD inattentiveness subscale score is defined as sum of items (1, 3, 5, 7, 9, 11, 13, 15, 17) scores (range 0 - 27). The ADHD hyperactive impulsive subscale score is defined as sum of items (2, 4, 6, 8, 10, 12, 14, 16, 18) scores (range 0 - 27).|Weeks 1, 2, 3, 4|Intent to treat|||units on a scale||Standard Error|Least Squares Mean
1358752|NCT01692782|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.|The CGI-S modified asked the clinician one question: Considering your total clinical experience with adult ADHD, how mentally ill is the subject at this time?”.The clinician’s answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = ng the most extremely ill subjects.|Weeks 1, 2, 3, 4|Intent to treat|||units on a scale||Standard Error|Least Squares Mean
1358753|NCT01692782|Secondary|Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores (range 0 - 54).|Weeks 1, 2, 3|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1358754|NCT01692782|Primary|Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV)|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.|4 Weeks|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1358755|NCT01692730|Secondary|Number of Participants With Biochemically Verified Abstinence From Tobacco|Our primary outcome is biochemically-verified point-prevalence abstinence at 6 months. If participant self-reports no cigarettes (or other tobacco use) in the past 7 days, the past 30 days, or since a specific self-reported cessation date, biochemical verification will be conducted to measure salivary cotinine (a cut off of <10ng/ml confirms self-reported abstinence for at least the previous 7 days). Using Intent-to-Treat analysis, subjects who drop out or refuse biochemical verification will be considered smokers.|6 month follow-up|Not all participants provided saliva. Analysis was performed on a total of 109 participants.|||Participants|||Count of Participants
1358756|NCT01692730|Primary|Number of Participants Who Self-report Abstinence From Tobacco|Our primary outcome is self-reported abstinence at the six month evaluation point. Abstinence outcomes at this time point are defined in three ways: 1) as self-reported abstinence (no cigarettes or other tobacco use) in the past 7 days prior to this six month time point, 2) or as no use in the past 30 days prior to this six-month time point (the 30 day period is the more conservative measure), or 3) self-reported prolonged abstinence from the time of a specific self-reported cessation date.|6 month follow-up|The primary outcome time point was six months. These 1,000 participants completed the six month time point evaluation.|||Participants|||Count of Participants
1358757|NCT01692691|Secondary|Median Duration of Response|To determine the median duration of response for patients who received Dacarbazine and Carmustine|8 weeks|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1358758|NCT01692691|Secondary|Response Rate|To determine the response rate after being treated with Dacarbazine Carmustine|8 weeks|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1358759|NCT01692691|Primary|Progression Free Survival|Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy|8 weeks|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
1358760|NCT01692626|Primary|Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face.|To determine if 1% pimecrolimus prevents the rash associated with treatment with cetuximab, as assessed by lesion counts on clinical photographs after two weeks of treatment.|2 weeks||||Participants|||Count of Participants
1358761|NCT01692340|Primary|Time of Maximal Carotenoid Concentration|We will determine when the maximal carotenoid concentration is achieved in the plasma|0 to 48 hours||||hours||Standard Error|Mean
1358762|NCT01692340|Primary|Maximal Plasma Carotenoid Concentration|We will determine the average maximal plasma carotenoid concentration in healthy volunteers|0 to 48 hours||||micromol||Standard Error|Mean
1358763|NCT01692340|Secondary|Carotenoid Metabolites|Study the metabolites produced from the labeled carotenoid in healthy subjects|Up to 28 days|Due to funding issues, at present we have not analyzed these samples for carotenoid metabolites. We have frozen plasma and if funds become available we would consider anlayzing the samples for carotenoid metabolites.||||||
1358764|NCT01692340|Primary|Plasma Half Life of Labeled Carotenoid|We will study the half life of isotopically labeled carotenoids.|labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.||||days||Standard Error|Mean
1358857|NCT01691612|Primary|Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours|"Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:~Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]"|from baseline to 48 hours||||percent of white blood cells||Full Range|Median
1358765|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)|Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
1358766|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
1358767|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
1358768|NCT01692301|Secondary|Change From Baseline in Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 * msDBP + msSBP)/3.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
1358769|NCT01692301|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (msPP)|Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
1358770|NCT01692301|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
1358771|NCT01692301|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
1358772|NCT01692301|Secondary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis.|||mmHg||Standard Error|Least Squares Mean
1358773|NCT01692301|Secondary|Change From Baseline in Mean Pulse Wave Velocity (PWV)|"Pulse wave velocity recordings were performed on patient while in a supine, face-up position.~Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52."|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12 , week 52).|||meter/second||Standard Error|Least Squares Mean
1358774|NCT01692301|Secondary|Change From Baseline in Mean Central Pulse (CPP) Pressure||Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12, week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis|||mmHg||Standard Error|Least Squares Mean
1358858|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8|Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1358775|NCT01692301|Primary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 12 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12).|||mmHg||Standard Error|Least Squares Mean
1358776|NCT01692197|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause or last follow-up.|Up to 5 years|Thirty seven patients are evaluable.|||months||Full Range|Median
1358777|NCT01692197|Secondary|Duration of Response|Response date to loss of response or last follow up.|Up to 5 years|Thirty seven patients are evaluable.|||months||Full Range|Median
1358778|NCT01692197|Secondary|Disease-free Survival|Time from date of treatment start until the date of first objective documentation of disease-relapse.|Up to 5 years|Thirty seven patients are evaluable.|||months||Full Range|Median
1358779|NCT01692197|Primary|Overall Response|Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.|2 cycles (60 days)|Thirty seven patients are evaluable.|||Participants|||Count of Participants
1358780|NCT01691898|Secondary|Cmax of Obinutuzumab: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Cmax of obinutuzumab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1358781|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
1358782|NCT01691898|Secondary|Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1358783|NCT01691898|Secondary|Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1358784|NCT01691898|Secondary|AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
1358785|NCT01691898|Secondary|AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*ng/mL||Standard Deviation|Mean
1358818|NCT01691898|Secondary|Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C)|OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to death due to any cause (from baseline up to data cut-off date, up to approximately 4.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||months||95% Confidence Interval|Median
1358786|NCT01691898|Secondary|AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
1358787|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
1358788|NCT01691898|Secondary|Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1358789|NCT01691898|Secondary|Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1358790|NCT01691898|Secondary|AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
1358791|NCT01691898|Secondary|AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*ng/mL||Standard Deviation|Mean
1358792|NCT01691898|Secondary|AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
1358793|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
1358794|NCT01691898|Secondary|Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1359722|NCT01682642|Secondary|Good Embryo Quality|The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.|3 days after oocyte retrieval||||percentage of good quality embryos|||Number
1358795|NCT01691898|Secondary|Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1358796|NCT01691898|Secondary|AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
1358797|NCT01691898|Secondary|AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*ng/mL||Standard Deviation|Mean
1358798|NCT01691898|Secondary|AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
1358799|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
1358800|NCT01691898|Secondary|Cmax of acMMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1358801|NCT01691898|Secondary|Cmax of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1358802|NCT01691898|Secondary|Area Under the Concentration-Time Curve From Time Zero To Last Measurable Concentration (AUClast) of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUClast of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
1358803|NCT01691898|Secondary|AUCinf of Antibody Conjugated Monomethyl Auristatin E (acMMAE) for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. Antibody conjugated MMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*nanogram (ng)/mL||Standard Deviation|Mean
1358819|NCT01691898|Secondary|Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)|Percentage of participants who died due to any cause was reported.|Baseline up to death due to any cause (from baseline up to data cut-off date, up to approximately 4.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||percentage of participants|||Number
1358804|NCT01691898|Secondary|AUCinf of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with Monomethyl Auristatin E (MMAE)-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
1358805|NCT01691898|Secondary|Volume of Distribution at Steady State (Vss) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|"Vss for rituximab was estimated from serum concentration data using non-compartmental analysis.~Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)"|Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mL/m^2||Standard Deviation|Mean
1358806|NCT01691898|Secondary|Half-Life (t1/2) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|"t1/2 for rituximab was estimated from serum concentration data using non-compartmental analysis.~Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)."|Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
1358807|NCT01691898|Secondary|Systemic Clearance (CL) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|CL for rituximab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mL/day/meter-square (m^2)||Standard Deviation|Mean
1358808|NCT01691898|Secondary|Maximum Observed Concentration (Cmax) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|Cmax for rituximab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1358809|NCT01691898|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|AUCinf for rituximab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable pharmacokinetic (PK) concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*micrograms (mcg)/milliliter (mL)||Standard Deviation|Mean
1358810|NCT01691898|Secondary|Percentage of Participants With Best OR Based on PET/CT or CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT or CT scan. Best OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|Baseline up to disease progression or death, whichever occurred first (up to approximately 2.5 years)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358811|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358812|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358813|NCT01691898|Secondary|Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358814|NCT01691898|Secondary|Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. CR was defined as reduction of longest transverse diameter (LDi) of target nodes/nodal masses to less than or equal to (</=) 1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358815|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by the Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358816|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358817|NCT01691898|Secondary|Percentage of Participants With CR at EOT Based on PET/CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358820|NCT01691898|Secondary|Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 3.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||months||95% Confidence Interval|Median
1358821|NCT01691898|Secondary|Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 3.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||percentage of participants|||Number
1358822|NCT01691898|Secondary|Number of Participants With ADA to Obinutuzumab|Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have “Treatment-induced ADAs” or “Treatment-enhanced ADA” during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.|Baseline, post-baseline (up to approximately 1.5 years)|Analysis was performed on safety-evaluable population (only participants who received obinutuzumab). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.|||participants|||Number
1358823|NCT01691898|Secondary|Number of Participants With ADA to Polatuzumab Vedotin|Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have “Treatment-induced ADAs” or “Treatment-enhanced ADA” during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.|Baseline, post-baseline (up to approximately 1.5 years)|Analysis was performed on safety-evaluable population (only participants who received polatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.|||participants|||Number
1358824|NCT01691898|Secondary|Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin|Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have “Treatment-induced ADAs” or “Treatment-enhanced ADA” during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result.|Baseline, post-baseline (up to approximately 1.5 years)|Analysis was performed on safety-evaluable population (only participants who received pinatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.|||participants|||Number
1358825|NCT01691898|Primary|Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H|Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [</=] mediastinum), or 3 (uptake less than [<] mediastinum but </=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1358855|NCT01691612|Secondary|Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours|Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]|from baseline to 48 hours||||percent change||Full Range|Mean
1358826|NCT01691898|Primary|Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.|First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population participants who achieved objective response.|||months||Full Range|Median
1358827|NCT01691898|Primary|Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.|Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population, which included all participants with baseline measurable disease and at least one post-baseline tumor assessment after study treatment.|||percentage of participants||90% Confidence Interval|Number
1358828|NCT01691885|Primary|Mean Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVI) at the End of the Overall Treatment Period|RVEDVI is a measure of the volume of blood in the right ventricle at the end of diastole, normalized over body surface area and was measured using Cardiac Magnetic Resonance (CMR) imaging. RVEDVI is calculated as the right ventricular end diastolic volume (RDEDV) divided by the body surface area (BSA). The change from Baseline in RVEDVI was analyzed using a mixed model analysis with period, treatment group, and Baseline RVEDVI fitted as fixed effects and participants fitted as a random effect. The Baseline is defined as the assessment performed pre-dose at Day 1 of Treatment Period 1. The change from Baseline is calculated as the RVEDVI value at the end of each treatment period minus the Baseline value. The Per Protocol (PP) Population was comprised of all participants in the modified intent-to-treat (mITT) Population not identified as having deviations considered to impact the primary efficacy analysis.|Baseline and end of Treatment Period (7 days)|PP Population. Only those participants available at the specified time points were analyzed|||Milliliter per meter square (mL/m^2)||Standard Error|Least Squares Mean
1358829|NCT01691859|Secondary|Number of Participants Who Withdrew Due to AE|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants who withdrew due to AE are presented.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358830|NCT01691859|Secondary|Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358831|NCT01691859|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy|Lack of efficacy referred to failure of expected pharmacological action of Mepolizumab. Number of participants who withdrew due to lack of efficacy are presented.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358832|NCT01691859|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)|Immunogenicity testing included two types of assays: a binding antibody assay (anti-drug antibody; ADA) and a neutralizing antibody (NAb) assay for participants who were tested positive in the ADA assay. Blood samples were collected for the determination of anti-mepolizumab antibodies, just prior to administration of mepolizumab. Samples that test positive for anti-mepolizumab antibodies were further tested for the presence of neutralizing antibody. Number of participants with positive highest value post-Baseline have been presented. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358856|NCT01691612|Secondary|Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours|Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]|from baseline to 48 hours||||percent change||Full Range|Median
1358833|NCT01691859|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is forced expiratory volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. FEV1 was measured by clinic spirometry. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Milliliters (mL)||Standard Deviation|Mean
1358834|NCT01691859|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ-5 is a five-item questionnaire, which was developed as a measure of participant’ asthma control that was completed by the participant. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze). The ACQ consists of 5 questions that are scored on a 7 point scale from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ score was derived as mean of five questions: ACQ score = Question 1 (Q1)+Q2+Q3+Q4+Q5 divided by 5 where Q1, Q2,... Q5 are the scores of Q1, Q2, ..., Q5, respectively. The total score ranged from zero (no impairment/limitation) which indicated best condition to six (total impairment/ limitation) which indicated worst asthma. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Scores on a Scale||Standard Deviation|Mean
1358835|NCT01691859|Secondary|Annualized Rate of On-treatment Exacerbations|Exacerbations were defined as worsening of asthma which required use of systemic corticosteroids and/or hospitalization and/or Emergency Department visits. Data is presented as mean which is exacerbation rate/year. Exacerbation data are performed using a negative binomial model with covariates of region, annualized rate of exacerbations in the interval between MEA112997 and MEA115666 (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|Baseline (Week 0) to Week 240|AT Population.|||Exacerbations per year||95% Confidence Interval|Mean
1358836|NCT01691859|Secondary|Mean Change From Baseline in Vital Signs-Sitting Pulse Rate|Vital signs included sitting pulse rate and blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Beats per minute||Standard Deviation|Mean
1358837|NCT01691859|Secondary|Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure|Vital signs included sitting pulse rate and sitting blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1358838|NCT01691859|Secondary|Number of Participants With Hematology Data of Potential Clinical Concern|Hematology parameters with laboratory ranges defining values of potential clinical concern included hemoglobin, hematocrit, platelet count, white blood cell count. Number of participants with clinical hematology abnormalities of potential clinical concern anytime post baseline are presented, which only included participants with low hemoglobin values. Only those participants who provided lab data post-baseline were analyzed.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358839|NCT01691859|Secondary|Number of Participants With Clinical Chemistry Data of Potential Clinical Concern|Clinical chemistry analytes with laboratory ranges defining values of potential clinical concern included sodium, potassium, calcium, phosphate, serum glucose and alanine aminotransferase. Number of participants with clinical chemistry abnormalities of potential clinical concern anytime post baseline are presented. Only those participants who provided lab data post-baseline were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358840|NCT01691859|Secondary|Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)|Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Number of participants with a maximum change from Baseline for QTc(F) and QTc(B) at any time post Baseline are presented. Only those participants who provided ECG data at baseline and post-baseline were analyzed.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358841|NCT01691859|Secondary|Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])|Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Milliseconds||Standard Deviation|Mean
1358842|NCT01691859|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])|Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Milliseconds||Standard Deviation|Mean
1359723|NCT01682642|Secondary|Pregnancy Rate|The number of ongoing pregnancies obtained which still is the most important issue for the patients.|12 weeks||||percentage of ongoing pregnancies|||Number
1358843|NCT01691859|Secondary|Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions|Systemic and local site reactions following mepolizumab dosing as identified by the investigator and the number of participants who experienced systemic and/or local site reactions are presented. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358844|NCT01691859|Primary|Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. As Treated (AT) Population consisted of participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
1358845|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)|Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500.|After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
1358846|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4|Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0.|After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
1358847|NCT01691794|Primary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
1358848|NCT01691781|Secondary|Serum Calcium Following 1 Week of ACE Inhibitor Administration||1 week||||mg/dL||Standard Deviation|Mean
1358849|NCT01691781|Secondary|Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy||1 week||||mcg/24 hours||Standard Deviation|Mean
1358850|NCT01691781|Primary|Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration|PTH values 1 week following ACE inhibitor therapy|1 week||||pg/mL||Standard Deviation|Mean
1358851|NCT01691690|Secondary|Time of First Opioid Analgesia in PACU|Mean time to first drug administration among patients requiring opioid analgesia in the PACU.|0-90 minutes post-operatively||||minutes||Standard Deviation|Mean
1358852|NCT01691690|Secondary|Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each|Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.|8-12 hours post-operatively|Comparing both groups for the time study subjects required breakthrough pain medication on the ward.|||Participants|||Count of Participants
1358853|NCT01691690|Primary|FLACC Pain Score Greater Than or Equal to 4|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score >/= 4 at one or more time points.|0-60 mins post-operatively||||Participants|||Count of Participants
1358854|NCT01691612|Secondary|Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours|Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours|from baseline to 48 hours||||percent of white blood cells||Full Range|Mean
1359724|NCT01682642|Primary|Number of Metaphase II Cells (MII)|number of MII cells retrieved|3 weeks||||MII cells||Standard Deviation|Mean
1358859|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4|Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1358860|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||grams||Standard Deviation|Mean
1358861|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant does not respond to air stimulation, 1 – participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1358862|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||grams||Standard Deviation|Mean
1358863|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 – participant does not respond to air stimulation, 1 – participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1358864|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Days 7-14)||Days 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||percentage of change in time/day||95% Confidence Interval|Mean
1358865|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Day 0-2)||Day 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||percentage of change in time/day||95% Confidence Interval|Mean
1358866|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)||Days 0-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||percentage of change in time/day||95% Confidence Interval|Mean
1358867|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 7-14)||Day 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||log10CFU/ml/day||95% Confidence Interval|Mean
1358868|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 0-2)||Days 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||log10CFU/ml/day||95% Confidence Interval|Mean
1358869|NCT01691534|Primary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).||14 consecutive days of treatment|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||log10CFU/ml/day||95% Confidence Interval|Mean
1358876|NCT01691508|Secondary|Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The number of participants who achieved a total reduction of OCS dose was based on the value of the MN dose. Total reduction implied no OCS use during the entire MN phase. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population|||Participants|||Number
1358870|NCT01691521|Secondary|Mean Change From Baseline in the St. George’s Respiratory Questionnaire Total Score at Week 32|The St. George’s Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. The lowest possible value is zero and the highest possible value is 100. The higher values correspond to greater impairment in quality of life. The questionnaire was administered at Baseline (Visit 2) and at the Exit Visit (approximately 4 weeks after the last dose of study treatment). The change from baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using analysis of covariance with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, and treatment.|Baseline, Week 32|ITT Population. Note that only participants with a Baseline and Week 32 assessment were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1358871|NCT01691521|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32|FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using mixed model repeated measures with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by baseline and visit by treatment group.|Baseline, Week 32|ITT Population. Only participants with a Baseline FEV1 available and at least one post-Baseline FEV1 measurement were analyzed.|||Milliliters (mL)||Standard Error|Least Squares Mean
1358872|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year|Clinically significant exacerbations of asthma is defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population|||Number of exacerbations per year|||Number
1358873|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population|||Number of exacerbations per year|||Number
1358874|NCT01691521|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|Modified Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of trial medication. ‘Modified’ implies that, in cases where there is is a discrepancy between randomized and actual treatment the analysis used the actual treatment received by the participant rather than the randomized treatment.|||Number of exacerbations per year|||Number
1358875|NCT01691508|Secondary|Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|BL dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent change of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (MN dose minus BL dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. For participants who withdrew from the study prior to the Maintenance Phase, and for participants with a lack of asthma control during the Maintenance Phase, a value equal to the minimum percent reduction in OCS use across all subjects was imputed for the analysis.|Baseline; Weeks 20 to 24|ITT Population|||Percentage reduction in OCS dose||95% Confidence Interval|Median
1358900|NCT01691339|Other Pre-specified|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) up to Day 21 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1358877|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control|Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg was based on the value of the MN dose. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population|||Participants|||Number
1358878|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|ITT Population|||Participants|||Number
1358879|NCT01691508|Primary|Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The percent reduction of OCS was categorized as: 90 to 100%; 75 to <90%; 50 to <75%; >0 to <50%; no decrease in prednisone dose, or lack of asthma control, or withdrawal (WD) from treatment. Analysis was performed using a proportional odds model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.|||Participants|||Number
1358880|NCT01691482|Secondary|Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population|||Liters||Standard Deviation|Mean
1358881|NCT01691482|Secondary|Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population|||Liters||Standard Deviation|Mean
1358882|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population|||Liters||Standard Error|Mean
1358883|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population|||percentage of days||Standard Deviation|Mean
1358884|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population|||percentage of days||Standard Deviation|Mean
1358924|NCT01690988|Secondary|Adverse Outcomes (Number of Patients With Nightmares)|Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive care Unit|Postoperative days 1-3||||Participants|||Count of Participants
1358885|NCT01691482|Secondary|The Maximal Bronchodilator Response for the First Administered Agent|The maximal bronchodilator response for the first administered agent is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) 1 hour post-dose of the first bronchodilator minus the pre-dose. The maximal bronchodilator response for the second agent is defined as the FEV1 1 hour post-dose of the second bronchodilator minus the FEV1 at 1 hour post-dose of the first bronchodilator. The maximal bronchodilator response for the combination is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) at 1 hour post-administration of the second bronchodilator minus the corresponding pre-dose FEV1. Derived FEV1 response is FEV1 change from 0 hours (0H) for the first agent assessment (at 1 hour [1H]); change from 1H for the second agent assessment (at 2 hours [2H]); and change from 0H for the combination assessment (at 2H). Data were adjusted for FEV1, smoking status, and center.|up to 10 days|Efficacy Population|||Liters||Standard Error|Least Squares Mean
1358886|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Coefficient of Variation|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population: participants in the Intent-to-Treat Population (all participants who were randomized and received at least one bronchodilator in the treatment period) who completed pre- and post- bronchodilator assessments for at least 17 visits, with no more than 3 consecutive missing days|||Liters||Standard Error|Mean
1358887|NCT01691430|Secondary|Subjects With 1, 2, or 3 Episodes of UTIs|Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.|One year|There were 10 symptomatic UTIs in the treatment group (8 participants with 1 episode and 1 participant with 2 episodes) and 12 symptomatic UTIs in the control group (7 participants with 1 episode, 1 participant with 2 episodes, and 1 participant with 3 episodes).|||participants|||Number
1358888|NCT01691430|Other Pre-specified|Adherence to Capsule Intake by All Participants|measured by capsules removed from blister packs|One year||||percentage of capsules|||Number
1358889|NCT01691430|Other Pre-specified|Number of Adverse Events in Participants||One year||||adverse events|||Number
1358890|NCT01691430|Secondary|Number of Antibiotic Prescriptions for Suspected UTI|Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.|One Year||||prescriptions|||Number
1358891|NCT01691430|Secondary|Bacteriuria With Multidrug-resistant Gram-negative Bacilli|All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).|One year||||episodes|||Number
1358892|NCT01691430|Secondary|Number of Antibiotic Prescriptions|Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.|One year||||prescriptions|||Number
1358893|NCT01691430|Secondary|Number of Deaths||One year||||participants|||Number
1358894|NCT01691430|Secondary|Number of Hospitalizations||One year||||hospitilizations|||Number
1358895|NCT01691430|Secondary|Number of Episodes of Symptomatic UTI|Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.|One year||||symptomatic urinary tract infections|||Number
1358896|NCT01691430|Primary|Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)|Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.|One year|147 subjects completed 1 year, 33 died. 20 subjects, 9 in the treatment group v 11 in the control group, became incontinent prior to the first time point, thus unable to provide any urine. 45 subjects stopped taking the capsules, 24 in treatment and 21 in control; 21 refused, 19 transitioned to hospice, 4 started warfarin, and 1 refused via family.|||participants|||Number
1358897|NCT01691339|Other Pre-specified|Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1358898|NCT01691339|Other Pre-specified|Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1358899|NCT01691339|Other Pre-specified|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1358925|NCT01690988|Secondary|Adverse Outcomes (Number of Patients With Hallucinations)|Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit|Postoperative days 1-3||||Participants|||Count of Participants
1358901|NCT01691339|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|"Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.~Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1358902|NCT01691326|Other Pre-specified|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
1358903|NCT01691326|Other Pre-specified|Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.|Day 28 after final vaccination|Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Participants|||Number
1358904|NCT01691326|Other Pre-specified|Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Participants|||Number
1358905|NCT01691326|Other Pre-specified|Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1358906|NCT01691326|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|"Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.~Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.~Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
1358907|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug|baseline through 24 hours||||participants|||Number
1358908|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug|baseline through 4 hours||||participants|||Number
1358909|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to Day 70 of study|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1358910|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 60 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1358911|NCT01691248|Primary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 30 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1358912|NCT01691092|Primary|Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging|PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.|1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine|13 healthy (6 males, 7 females) and 14 MDD non-smokers (4 males, 10 females) Mean age: 33.5 ± 13.2 yrs reasons for discrepancy (participant flow module): some data was not able to be analyzed due to elevated metabolites; some subject did not tolerate ketamine and had to be pulled out of scanner so we could not obtain data.|||percentage reduction||Standard Deviation|Mean
1358913|NCT01691027|Secondary|Stylus to Eclipse Area||Base line, Pre and Post training (approximately 3 months)|Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.|||Degree|||Number
1358914|NCT01691027|Primary|Improvement in Eye-hand Coordination|Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination|base line, pre-test, post tracing and videogames training|Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.|||Percentage|||Number
1358915|NCT01691014|Secondary|Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12|HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Baseline, Month 3, 6, 12|"EAS included all participants that provided at least 1 post-baseline assessment. Here, n signifies number of participants evaluable for this outcome measure at the specified time points."|||units on a scale||Standard Deviation|Mean
1358916|NCT01691014|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12|DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity.|Month 3, 6, 12|EAS included all participants that provided at least 1 post-baseline assessment. Here,”n” signifies number of participants evaluable at the specified time points for this outcome measure.|||units on a scale||Standard Deviation|Mean
1358917|NCT01691014|Secondary|Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment|Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.|Month 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
1358918|NCT01691014|Secondary|Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 3, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
1358919|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
1358920|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
1358921|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
1358922|NCT01691014|Primary|Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
1358923|NCT01691014|Primary|Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
1358927|NCT01690988|Secondary|Number of Patients With Postoperative Nausea and Vomiting|"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM & PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3~The incidence of nausea and or vomiting was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg) for POD 1-3 and overall."|Postoperative days 1-3||||Participants|||Count of Participants
1358928|NCT01690988|Secondary|Median Opioid Consumption|"Assessed from patients' medical charts. All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"|Postoperative days 0-3||||mg||Full Range|Median
1358929|NCT01690988|Secondary|Daily Maximum Pain Recorded|Assessed by observer-based Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) with subsequent administration of patient-reported Visual Analog Scale The behavioral pain scale has three domains and ranges from 3 to 15. The visual analog scale is a continuous scale from 0 to 100 mm. Daily Maximum Pain accounted for pain level in the AM or PM for both the VAS and the BPS/BPS-NI a higher value means a worse outcome.|Postoperative days 1-3, two assessment daily (morning and afternoon), with at least six hours between assessments||||participants||Inter-Quartile Range|Median
1358930|NCT01690988|Primary|Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3|"According to Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit criteria the number of patients that had any positive CAM on any day for all patients. The main effect evaluated will be to determine whether ketamine decreases delirium, table 3 of the protocol provides a useful guide for the potential findings of the current study with their implications.~To further clarify, delirium will be assessed on the day of surgery, when possible and on the subsequent three days POD 1-3, as long as as patients remain in the hospital and are assessable (i.e., not sedated to a RASS <-3). The assessments on POD 1-3 will be done twice daily, once in the morning and once in the afternoon. The primary outcome of the study includes only the delirium incidence on POD 1-3.~The primary comparison will be between the combined ketamine groups and the placebo group."|Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients|Of all 672 participants, data were analyzed AM and PM and post operative day 1 through day 3 for screened participants with a CAM. The overall incidence of delirium were compared, Ketamine 0.5 mg/kg and 1 mg/kg groups were combined as per-specified in the study protocol.|||Participants|||Count of Participants
1358931|NCT01690923|Primary|AHI on Nasal Mask and Pillows Mask|AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour|7 days||||events/hour||Standard Deviation|Mean
1358932|NCT01690923|Secondary|Usability|Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)|After 7 days of use||||Units on a scale||Inter-Quartile Range|Median
1358933|NCT01690663|Secondary|The Secondary Outcome Variable is Post Operative Motor Block Duration|This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.|days 1, 2, and day 7||||hours||Inter-Quartile Range|Mean
1358934|NCT01690663|Primary|Primary Outcome Variable is Post Operative Sensory Block Duration|This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.|days 1, 2, and day 7||||hours||Inter-Quartile Range|Mean
1358935|NCT01690546|Secondary|Number of Participants That Self Reported Illicit Drug Use|Participants reported on any illicit drug use to include Cocaine marijuana opiates|4 weeks||||participants|||Number
1358936|NCT01690546|Secondary|Use of Ancillary Medications.|Number of participants that took ancillary medication|baseline to week 1||||participants|||Number
1358937|NCT01690546|Secondary|Percentage of Participants With Adherence to Medication (Naltrexone)|Participant who took Naltrexone as prescribed.|Day 1 to Day 8 (+/- 2 days)||||percentage of participants|||Number
1358938|NCT01690546|Secondary|Percentage of Participants Who Adhered to Study Visits.||baseline to end of study (approximately 40 days)||||percentage of participants|||Number
1358939|NCT01690546|Secondary|Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire|"Questionnaire consisted of 3 questions.~Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5).~Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5).~Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5).~Lower scores represent greater satisfaction."|Day 9||||units on a scale||Standard Deviation|Mean
1358940|NCT01690546|Secondary|Illicit Drug Use, Measured by Urine Drug Testing|number of participants that tested positive for marijuana, cocaine, and opiates.|4 weeks||||participants|||Number
1358941|NCT01690546|Secondary|Craving|Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from ‘not at all’ (0) to ‘more than ever’ (100). The higher the score the higher the craving.|4 weeks||||units on a scale||Standard Deviation|Mean
1358942|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms."|4 weeks||||units on a scale||Standard Deviation|Mean
1359725|NCT01682603|Other Pre-specified|Autonomic Dysreflexia||Baseline and 12 months||||participants|||Number
1358943|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal."|4 weeks|All participants who received the Extended Release Injectable NTX|||units on a scale||Standard Deviation|Mean
1358944|NCT01690546|Primary|Retention in Treatment|After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.|4 weeks|All participants who received the Extended Release Injectable NTX|||participants|||Number
1358945|NCT01690299|Secondary|Psoriasis Flare/Rebound|Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.|From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.|Safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
1358946|NCT01690299|Secondary|Psoriasis Flare/Rebound|Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.|Week 0 to Week 16; Placebo controlled phase|Safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
1358947|NCT01690299|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period|A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject’s health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.|From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose|All participants who received apremilast at any time during the study.|||participants|||Number
1358948|NCT01690299|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.|Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group|Safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
1358949|NCT01690299|Secondary|Percentage of Participants Who Achieved a Lattice System Physician’s Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The Lattice System Physician’s Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||percentage of participants|||Number
1358973|NCT01690143|Primary|Median Time for Neutrophil and Platelet Engraftment.|Neutrophil engraftment is defined as the first of three consecutive days with absolute neutrophil count >500/mm3. Platelet engraftment is defined as the first of 3 consecutive days of platelets > 20,000/mm3 without platelet transfusion in the prior 7 days.|Up to 1 month.|All patients|||days||Full Range|Median
1358974|NCT01690143|Primary|Complete Response (CR) Rate.|CR defined as the following: Negative immunofixation of the serum and urine. If only the measurable non-bone marrow parameter was free light chain, normalization of free light chain ratio. < 5% plasma cells in bone marrow. And, disappearance of any soft tissue plasmacytomas.|Up to 17 months||||Participants|||Count of Participants
1358950|NCT01690299|Secondary|Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value − baseline value.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||units on a scale||95% Confidence Interval|Least Squares Mean
1358951|NCT01690299|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||units on a scale||95% Confidence Interval|Least Squares Mean
1358952|NCT01690299|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||percentage of participants|||Number
1358953|NCT01690299|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||percent change||95% Confidence Interval|Least Squares Mean
1358954|NCT01690299|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline and Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||percentage of participants|||Number
1358975|NCT01690143|Primary|Very Good Partial Response (VGPR) Rate.|"VGPR defined as any one of the following:~≥ 90% reduction of serum M-protein; ≥ 90% reduction in 24-hour urinary M-protein or decrease to < 100 mg per 24 hour; ≥ 50% decrease in the difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio; ≥ 50% reduction in bone marrow plasma cells; ≥ 50% reduction in the size of soft tissue plasmacytomas."|Up to 17 months|All patients who underwent transplantation|||Participants|||Count of Participants
1358976|NCT01690143|Primary|Maximum Tolerated Dose (MTD) of Carfilzomib Plus Melphalan as Conditioning for Autologous Hematopoietic Cell Transplantation in Patients With Relapsed Multiple Myeloma(MM) [Phase I Portion of Study]|The maximum tolerated dose of carfilzomib that can be safely combined with high dose melphalan as conditioning regimen prior to autologous hematopoietic cell transplantation in patients with relapsed multiple myeloma meeting eligibility criteria.|Up to 4 1/2 months|Patients who underwent transplantation during phase 1|||mg/m2|||Number
1358955|NCT01690299|Secondary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline and Week 16|mITT population consisted of all participants who were re-randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||percentage of participants|||Number
1358956|NCT01690299|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||Percentage of participants|||Number
1358957|NCT01690273|Secondary|Chest Expansion|Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
1358958|NCT01690273|Secondary|Finger Floor Distance|Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
1358959|NCT01690273|Secondary|Tragus-coronoid Distance|lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
1358960|NCT01690273|Secondary|Chin-coronoid Distance|lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
1358961|NCT01690273|Secondary|MASES|Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Number of painful tender points||Standard Deviation|Mean
1358962|NCT01690273|Secondary|Short Form-12 (MCS)|Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1358963|NCT01690273|Secondary|Short Form-12 (PCS)|Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1358964|NCT01690273|Secondary|Stiffness Scale|Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1358965|NCT01690273|Secondary|Pain Scale|Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1358966|NCT01690273|Secondary|Thoracolumbar Mobility|Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
1358967|NCT01690273|Primary|Global Evaluation Self Reported|Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Median
1358968|NCT01690273|Primary|Ankylosing Spondylitis Disease Activity Scale -Disease Activity|Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1358969|NCT01690273|Primary|Disease Activity Index|BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1358970|NCT01690273|Primary|Mobility Index|Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)|Baseline and 16 weeks||||units on a scale from 0 to 10||Standard Deviation|Mean
1358971|NCT01690273|Primary|FUNCTIONAL INDEX|BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1358977|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358978|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358979|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358980|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358981|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 - physical component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358982|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358983|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358984|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1359011|NCT01689779|Other Pre-specified|Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.|Patients will be followed between the day of surgery and an average duration of 14 days after surgery|Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery|||Percent change in 25(OH)D||Standard Deviation|Mean
1358985|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)|baseline and month 9|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358986|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)|baseline and month 6|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358987|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358988|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)|baseline and month 6|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358989|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358990|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)|baseline and 6 month|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358991|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).|baseline and month 9|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358992|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).|baseline and month 6|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS (Statistical Package for the Social Sciences ) - methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
1358993|NCT01690052|Other Pre-specified|Adverse Events|Adverse events related to the combination and order of study medication will be measured|four weeks|||||||
1358994|NCT01690052|Primary|Change From Baseline in Saliva Production in ml.|"The primary outcome measure was the change of stimulated and non-stimulated saliva in ml from the baseline record.~At each appointment (weekly), participants will provide 2 saliva samples to measure their current salivary output. The first measurement will be obtained by having the patient spit as much as he or she could into a cup for five minutes. The amount of saliva in ml will be recorded.~The second measurement will be obtained in a similar manner with the addition of having the patient chew on a block of unflavored wax. Patients will complete weekly questionnaires to help determine which side-effects they experience as they take the medications."|4 weeks||||ml||Standard Deviation|Mean
1358995|NCT01690000|Secondary|Changes in Calcium Homeostasis|Calcium homeostasis will be analyzed through blood and urines samples|baseline, after 3, 6, 9 months, and end of study (after 12 months)|||||||
1358996|NCT01690000|Primary|Changes in Bone Mineral Density (BMD)|Effects of melatonin on BMD will be assessed through DXA-scans|baseline and end of study (after 12 months)||||percentage of change in BMD||Standard Error|Mean
1361800|NCT01662102|Secondary|Event Free Survival|EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).|Up to 7 years|||||||
1358997|NCT01689974|Primary|Response Rates of Ipilimumab Alone and of Ipilimumab With Radiation Therapy and to Estimate the Difference Between Response Rates With Ipilimumab Alone and Ipilimumab With Radiation Therapy|Eligible patients have metastatic melanoma with at least 2 measurable sites of disease. All patients with metastatic melanoma are eligible to be randomly assigned to Ipilimumab 3mg/kg IV over 90 minutes versus Ipilimumab 3 mg/kg IV over 90 minutes and radiotherapy to one of their measurable lesions, 6 Gy X5 (conformally or by IMRT/IGRT, to maximally spare normal tissue). For patients assigned to the Ipi/RT arm, Ipilimumab treatment starts after radiotherapy, with a dose given on day 4 from the first radiotherapy fraction and repeated on Days 25, 46 and 67. Patients will be re-imaged on Week 12 and evaluated for response (defined as an objective response of another metastatic site outside the radiation field). This response will be evaluated assessing clinical and CT responses in the non-irradiated measurable metastatic sites.|2 years|Study terminated because PI left institution. Data cannot be reported because 2 year data were not collected and were not analyzed.||||||
1358998|NCT01689909|Other Pre-specified|Actigraphy|This device measures arm motion over time.|8 weeks of treatment||2018-12-31|12/2018||||
1358999|NCT01689909|Other Pre-specified|Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale|This is one of the subscales of the Basis 32. It is self-administered. This subscale has 7 items, each scored 0-4. The totals score is an average of the scores of these 7 items. Higher scores indicate more difficulty with daily living and role functioning.|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1359000|NCT01689909|Secondary|Insomnia Severity Index (ISI)|The Insomnia Severity Index is self rated. It has 7 items, each scored 0-4. Therefore the range of scores is 0-28, with higher scores indicating worse insomnia|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1359001|NCT01689909|Secondary|Hamilton Rating Scale for Depression (HAM-D)|This version of the Hamilton Rating Scale for Depression uses 24 items, with a possible total score ranging from 0-74, with higher scores indicating worse depression|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1359002|NCT01689909|Secondary|Beck Hopelessness Scale (BHS)|The Beck Hopelessness Scale is self administered and has 20 'true/false' choices. Some items are reversed scored. The range of scores for the total is 0-20, with higher scores indicating greater hopelessness|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1359003|NCT01689909|Secondary|Disturbing Dreams and Nightmares Severity Index (DDNSI)|This self-rated scale has 5 items, with asymmetric weighting of each item. The range of the total score is 0-37, with higher scores indicating worse nightmares|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1359004|NCT01689909|Secondary|Dysfunctional Beliefs and Attitudes About Sleep|The Dysfunctional Beliefs and Attitudes About Sleep scale has 16 items and is self administered. Each item is scored 0-10. The total score is an average of the scores of the 16 items. Hence the range of the total score is also 0-10, with higher scores indicating greater dysfunctional beliefs about sleep|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1359005|NCT01689909|Primary|Suicide Severity Index (SSI)|This is the total score for the Scale for Suicide Ideation. It has 19 items, each scored 0-2, for a maximum of 38 points. Higher scores indicate worse suicidal ideation|At the end of 8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
1359006|NCT01689857|Secondary|Satisfaction for Serviceability|Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire|the end of the 3 month of the treatment|||||||
1359007|NCT01689857|Primary|Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months|"Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.~vascularity(range from normal(0 point) to purple(3point)~pigmentation(range from normal(0 point) to hyper-pigmentation(3point)~pliability(range from normal(0 point) to contracture(5point)~height (range from flat(0 point) to above 5mm(3point)~pain(range from none(0 point) to Require medication(2point)~itchiness(range from none(0 point) to Require medication(2point)~We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition."|Baseline and 3 months|All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.|||units on a scale||Standard Deviation|Mean
1359008|NCT01689779|Other Pre-specified|Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.|Patients will be followed between the day of surgery and an average duration of 14 days after surgery|Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery|||Percent change in LL-37||Standard Deviation|Mean
1359009|NCT01689779|Secondary|Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.|Patients will be followed between the day of surgery and 1 day after surgery|Data are presented as percent change in levels between baseline assessment and day after surgery|||Percent change in LL-37||Standard Deviation|Mean
1359010|NCT01689779|Primary|Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol|3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37|Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days|Data are presented as percent change in levels between baseline assessment and day of surgery|||percent change in LL-37||Standard Deviation|Mean
1359044|NCT01689532|Secondary|Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24|Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
1359012|NCT01689779|Secondary|Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.|Patients will be followed between the day of surgery and 1 day after surgery|Data are presented as percent change in levels between baseline assessment and day after surgery|||Percent change in 25(OH)D||Standard Deviation|Mean
1359013|NCT01689779|Primary|Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol|3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37|Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days|Data are presented as percent change in levels between baseline assessment and day of surgery|||percent change in 25(OH)D||Standard Deviation|Mean
1359014|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment||Month 4||||percentage of participants|||Number
1359015|NCT01689649|Secondary|General Clinical Assessment Before and After Treatment|The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).|Baseline (Day 0) and Month 4||||percentage of participants|||Number
1359016|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks||Month 4||||percentage of participants|||Number
1359017|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks||Month 1, Month 3 and Month 4||||percentage of participants|||Number
1359018|NCT01689649|Primary|Percentage of Seizure Free Participants During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4||||percentage of participants|||Number
1359019|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4||||percentage of participants|||Number
1359020|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4||||percentage of participants|||Number
1359021|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52|"Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1359022|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52|The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1359023|NCT01689532|Secondary|Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1359024|NCT01689532|Secondary|Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1360907|NCT01669434|Secondary|Older Age Subgroup|Only patients above the age of 64 will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg|During anesthesia, an expected average of 3 hours.||||Participants|||Count of Participants
1359025|NCT01689532|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||minute||Standard Deviation|Mean
1359026|NCT01689532|Secondary|Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52|HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.|Baseline, Weeks 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale*week||Standard Deviation|Mean
1359027|NCT01689532|Secondary|Percentage of Participants Maintaining HAQ-DI Response|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of > -0.22 in HAQ-DI score.|Baseline upto Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359028|NCT01689532|Secondary|Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of > -0.22 from baseline in HAQ-DI score.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359029|NCT01689532|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, at Week 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1359030|NCT01689532|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI <=3.3; Low Disease Activity SDAI >3.3 and <=11; Moderate Disease Activity SDAI >11 and <=26; High Disease Activity SDAI >26.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1359031|NCT01689532|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24|The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1359032|NCT01689532|Secondary|Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52|The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 to 10 scale.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359033|NCT01689532|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician’s global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at the visit.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359931|NCT01680991|Secondary|Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1359034|NCT01689532|Secondary|Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
1359035|NCT01689532|Secondary|Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.|At Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359036|NCT01689532|Secondary|Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359037|NCT01689532|Secondary|Percentage of Participants Who Achieved Major Clinical Response at Week 52|Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).|Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359038|NCT01689532|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24|Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
1359039|NCT01689532|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, ‘n’ signifies those participants who were evaluable for the specific timepoint.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
1359040|NCT01689532|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24|Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
1359041|NCT01689532|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24|Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
1359042|NCT01689532|Secondary|Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24|Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
1359043|NCT01689532|Secondary|Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24|Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
1361801|NCT01662102|Secondary|Complete Response Rate|Complete Response (CR) rates post randomization|Up to 24 months|||||||
1359045|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response|The ACR 90 Response is defined as >=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359046|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response|The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359047|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response|The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359048|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
1359049|NCT01689532|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.|Baseline upto Week 68|Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.|||participants|||Number
1359050|NCT01689519|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 28 August 2015 Overall Survival data cut-off (up to 2 years, 8 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Months||95% Confidence Interval|Median
1359051|NCT01689519|Secondary|Duration of Response|Duration of response was defined as the time from first occurrence of a documented confirmed objective response until the time of disease progression, as determined by investigator review of tumor assessments using Response Evaluation Criteria in Solid Tumors v1.1 or death from any cause during the study. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received. Only participants with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
1359052|NCT01689519|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors v1.1. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Percentage of participants||95% Confidence Interval|Number
1359053|NCT01689519|Secondary|Overall Survival|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Months||95% Confidence Interval|Median
1359080|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score|The LEAS is an 18-level single-question self-administered scale that has been validated as a clinical outcome measure for the assessment of participants’ actual activity levels. The LEAS is scaled from 1 to 18, with 18 indicating levels of highest activity. Change from baseline in LEAS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359054|NCT01689519|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Months||95% Confidence Interval|Median
1359055|NCT01689441|Secondary|Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours|NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations.|48 hours|"The discrepancy in number of participants analyzed for this outcome vs. other outcomes is due to urine samples not being available in all participants"|||mg/mg||Inter-Quartile Range|Median
1359056|NCT01689441|Secondary|Plasma Interleukin-6 (IL-6) Levels at 48 Hours||48 hours||||pg/ml||Inter-Quartile Range|Median
1359057|NCT01689441|Primary|Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours||48 hours||||ng/ml||Inter-Quartile Range|Median
1359058|NCT01689363|Secondary|Allergic Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
1359059|NCT01689363|Secondary|Erythema Responder Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||percentage of participants|||Number
1359060|NCT01689363|Secondary|Local Itchiness Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||percentage of participants|||Number
1359061|NCT01689363|Secondary|Allergic Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
1359062|NCT01689363|Secondary|Observed Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
1359063|NCT01689363|Secondary|Observed Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
1359064|NCT01689363|Secondary|Erythema Responder Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||percentage of participants|||Number
1359065|NCT01689363|Secondary|Local Itchiness Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||percentage of participants|||Number
1359066|NCT01689363|Secondary|Allergic Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
1359067|NCT01689363|Secondary|Allergic Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
1359068|NCT01689363|Secondary|Observed Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
1359069|NCT01689363|Secondary|Observed Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
1359070|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||participants|||Number
1359071|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||participants|||Number
1359072|NCT01689350|Secondary|Adverse Reaction ( Infection )|Flu-like symptoms, Upper respiratory tract infection，and the etc.|one month||||participants|||Number
1359073|NCT01689350|Primary|Adverse Reaction (Leucopenia)|The count of white cells < 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.|one month||||participants|||Number
1359074|NCT01689337|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 60|The safety analysis set included all participants who received at least 1 dose of trial drug.|||participants|||Number
1359075|NCT01689337|Secondary|Six-minute Walk Test|Six (6)-minute walk test is used to measure gait function and for pre- and post-operative evaluation in cartilage injury repair. Maximum comfortable distance (in meters) that a participant can walk in 6 minutes was to be reported.|Every 3 months up to 5 years beyond Month 6 post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359076|NCT01689337|Secondary|Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score|The MOCART score is used to describe the constitution of the cartilage repair tissue and the surrounding structures.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359077|NCT01689337|Secondary|Volume of the Refilled Cartilage|Volume of the refilled cartilage was to be measured by MRI.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359078|NCT01689337|Secondary|Composition of the Refilled Cartilage Using T2 Mapping|The transverse relaxation time T2 mapping is an MRI technique that is able to evaluate collagen organization and orientation within cartilage. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359079|NCT01689337|Secondary|Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score|The Lysholm knee scale is a physician-reported outcome measure to assess knee function after ligament injury. It is scaled from 0 to 100 with higher scores representing better function. Change from baseline in Lysholm knee scale score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359092|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.|Day 0 pre-vaccination|Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
1359081|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score|Knee pain was to be rated by the participant using an 11-point NRS of pain intensity. The NRS is scaled from 0 (no pain) to 10 (worst possible pain). Change from baseline in NRS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359082|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, FSR, and impact on QOL (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in total KOOS score; other symptoms, knee-related QOL, and FSR sub-scores; and total KOOS minus FSR sub-score was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359083|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scores for Pain and Activities of Daily Living (ADL)|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, function in sport and recreation (FSR), and impact on quality of life (QOL) (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in pain and ADL sub-scores was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359084|NCT01689337|Secondary|Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years beyond 6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359085|NCT01689337|Primary|Composition of the Refilled Cartilage Measured by Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) Using T1 Relaxation Time at Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
1359086|NCT01689324|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®|"Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.~Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set|||Participants|||Number
1359087|NCT01689324|Other Pre-specified|Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
1359088|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
1359089|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
1359090|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
1359091|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.|||Percentage of Participants|||Number
1359093|NCT01689324|Primary|Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
1359094|NCT01689324|Primary|Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|"Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.~Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL."|Day 28 post-vaccination|Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
1359095|NCT01689324|Primary|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.|Day 28 post-vaccination|Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
1359096|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Volume of distribution at steady state (Vss).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||L||Geometric Coefficient of Variation|Geometric Mean
1359097|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Systemic clearence (CL) and renal clearance (CLr) on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||L/h||Geometric Coefficient of Variation|Geometric Mean
1359098|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Maximum plasma concentration (Cmax µg/mL) on Day 1 after single infusion , maximum plasma concentration at steady state (Css,max µg/mL) after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1359099|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C|Time to Cmax (tmax)|Day 1|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||(h)||Full Range|Median
1359100|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Terminal half-life (t1/2), on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||h||Geometric Coefficient of Variation|Geometric Mean
1359101|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Area under the plasma concentration-time curve from zero extrapolated to infinity (AUC µg*h/mL) or AUC(0-last) in Part A on Day 1 after single infusion, area under the plasma concentration-time curve at steady state after multiple infusion (AUCss µg*h/mL).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness.|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
1359102|NCT01689207|Primary|Safety Profile - Number of Subjects With at Least 1 AE|from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.|Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)|Safety population|||Participants|||Number
1359103|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Clinic Database.|Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.|||Events per 1,000 person-months|||Number
1359104|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Hospital Database.|Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.|||Events per 1,000 person-months|||Number
1359105|NCT01689155|Primary|Rates of Safety Outcomes at Days 0–30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.|Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.|Day 0 up to Day 75 post-vaccination|Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.|||Events per 1,000 person-months|||Number
1359106|NCT01688921|Secondary|Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again||28 Days|Safety population|||Percent of Participants|||Number
1359107|NCT01688921|Secondary|Number of Subjects With Spontaneously Reported Adverse Events|"Subjects will be asked to report any other symptoms experienced in addition to the solicited immediate and vaccine reactogenicity events. Any other events reported will be tabulated as spontaneously reported adverse events."|28 days|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).|||participants with spontaneous AEs|||Number
1359108|NCT01688921|Secondary|Number of Subjects With Vaccine Reactogenicity Events|Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.|Day 0, 1, 2, 3, 4, 5, and 6|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card.|||participants|||Number
1359109|NCT01688921|Secondary|Number of Subjects With Complaints Within 30 Minutes Following Vaccination||Within 30 minutes post-vaccination|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).|||participants|||Number
1359110|NCT01688921|Primary|Anti Influenza Type B Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Percent of Participants|||Number
1359111|NCT01688921|Primary|Anti Influenza Type A/H3N2 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days||||Percent of Participants|||Number
1359112|NCT01688921|Primary|Anti Influenza Type A/H1N1 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Percent of Participants|||Number
1359113|NCT01688921|Primary|Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Titers||Standard Deviation|Geometric Mean
1359114|NCT01688921|Primary|Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Titers||Standard Deviation|Geometric Mean
1359115|NCT01688921|Primary|Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Titers||Standard Deviation|Geometric Mean
1359116|NCT01688882|Secondary|Number of Patients Investigator Global Assessment Score Over 12 Weeks|Investigator’s Global Assessment (IGA) - (scale of 0 to 4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe)|Baseline (week 0), week 6 and week 12|Pharmacodynamics (PD) analysis set included all randomized patients.|||Number of participants|||Number
1359176|NCT01688102|Primary|Change in LDL Cholesterol Level||baseline and 6 months or last observation carried forward (minimum 2 months)||||mg/dl||Standard Deviation|Mean
1359359|NCT01685840|Secondary|EQ-5D Visual Analog Scale|The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, 3, 6, 12 and 24 months||||units on a scale||Standard Deviation|Mean
1359117|NCT01688882|Secondary|Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 6 weeks based on the CGA-C score in bullous pemphigoid (BP).~A patient with a CGA-C score of 3 or 4 indicating marked improvement from baseline at 6 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|6 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.|||number of participants|||Number
1359118|NCT01688882|Primary|Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 12 weeks based on the CGA-C in bullous pemphigoid (BP).~A patient with a CGA-C score of 3 or 4 indicating ‘at least marked improvement from baseline’ at 12 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|12 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.|||number of participants|||Number
1359119|NCT01688843|Primary|Effectiveness 3|Clinically acceptable pacing impedance between 300 Ω and 1300 Ω|Lead implant through 3 month follow up||||Ω|Implant/Attempted Leads|95% Confidence Interval|Mean
1359120|NCT01688843|Primary|Effectiveness 2(Right Ventricle)|R-wave sensed amplitude at three months post-implant > 5 mV|Lead implant through 3 month follow up||||mV|Implant/Attempted Leads|95% Confidence Interval|Mean
1359121|NCT01688843|Primary|Effectiveness 2(Right Atrium)|P-wave sensed amplitude at three months post-implant > 1.5 mV|Lead implant through 3 month follow up||||mV|Implant/Attempted Leads|95% Confidence Interval|Mean
1359122|NCT01688843|Primary|Effectiveness 1|The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V|Lead implant through 3 month follow up||||volts|Implant/Attempted Leads|95% Confidence Interval|Mean
1359123|NCT01688843|Primary|Safety 3 - Hazard Rate of Lead-Related Complications|Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.|Implant through 12 months (including available data beyond 12 months)|Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.|||hazard rate of lead-related complication|Leads Implanted/Attempted|95% Confidence Interval|Number
1359124|NCT01688843|Primary|Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)|Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.|3 months through 12 months post implant|Leads still in service and implanted in actively followed participants at 92 days were included in analysis.|||percentage of leads complication-free|Implant/Attempted Leads|95% Confidence Interval|Number
1359125|NCT01688843|Primary|Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)|Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%|Lead implant through 3 month follow up|Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.|||percentage of leads complication-free|Implant/Attempted Leads|95% Confidence Interval|Number
1359126|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."|||ratio||Standard Deviation|Mean
1359127|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."|||ratio||Standard Deviation|Mean
1359128|NCT01688830|Secondary|AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4|AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4|2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1359129|NCT01688830|Secondary|C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)|"Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.~The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). “BLQ” values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable."|1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4|"Pharmadynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1359130|NCT01688830|Secondary|Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran|"Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4~Ae(0-12h,ss) of sum dabigatran"|Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||μg||Geometric Coefficient of Variation|Geometric Mean
1359131|NCT01688830|Primary|Number of Subjects With Drug Related Adverse Events (AE)|Frequency of subjects with related adverse events (AE) by treatment|AEs occurring until end of follow-up (Up to 3 months after last drug administration)|Treated set|||participants|||Number
1359132|NCT01688830|Secondary|Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)|"Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)~Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion."|Up to 7 hours|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||μmol||Geometric Coefficient of Variation|Geometric Mean
1359133|NCT01688830|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab|AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1359134|NCT01688830|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab|tmax (time from dosing to maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||hours||Full Range|Median
1359135|NCT01688830|Secondary|Cmax (Maximum Measured Concentration) for Idarucizumab|Cmax (maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|Pharmacokinetic set (PKS) comprises of all subjects (with evaluable observations) in the TS who provided at least 1 PK endpoint and had no important protocol violations relevant to the evaluation of PK and additionally for Part 2 and 3 had no emesis with onset at or before twice the median tmax of dabigatran.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1359136|NCT01688726|Secondary|Non Invasive Tear Film Break-up-time (NIBUT)|NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.|||seconds||Standard Deviation|Mean
1359137|NCT01688726|Secondary|High Contrast logMAR Time Controlled Visual Acuity (TCVA)|TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.|||logMAR||Standard Deviation|Mean
1359138|NCT01688726|Primary|Mean Bulbar Conjunctival Staining|The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.|||percentage of staining||Standard Deviation|Mean
1359139|NCT01688635|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Gtot. Participants were analyzed based on the treatment they received.|||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1359610|NCT01683604|Primary|C-Reactive Protein (CRP) at Baseline|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline|FAS population.|||milligrams per liter (mg/L)||Standard Deviation|Mean
1359140|NCT01688635|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Rmax. Participants were analyzed based on the treatment they received.|||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
1359141|NCT01688635|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus||30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received|||picomoles/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1359142|NCT01688635|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus|The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.|||picomoles*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1359143|NCT01688609|Secondary|Number of Participants With Treatment-Related Toxicities||Up to 12 weeks after completion of study treatment||||participants|||Number
1359144|NCT01688609|Secondary|EGFR-mutation Status of Tumors and Changes in the Ratio of Phosphorylated to Nonphosphorylated HER2, EGFR, ERK, Akt, and the Ki67 and TUNEL Indices Before and After Treatment|The EGFR mutation status will be a binary variable (yes vs. no), and the phosphorylation status of HER2 and EGFR will be a ratio variable (0-100%). The CART method to identify cut-off points for the phosphorylation ratio of molecules of interest will be used, such that ratios above the cut-off point will be considered “high phosphorylation” and ratios below the cut-off point will be considered “low phosphorylation.”|From baseline to 24 weeks|The study was not able to determine the cut off value of total and phorylated RTK ratio. Assays were not reliable. Data of EGFR mutations were not collected.||||||
1359145|NCT01688609|Secondary|Cellular Response Rate, Defined as Patients With an Epithelial Phenotype Having Eradication of CTCs; Patients With a Mesenchymal Phenotype Having Eradication of Tumor Cells; Patients With a Mesenchymal Phenotype Converting to an Epithelial Phenotype|Cellular response will be documented and calculated for rate in all patients.|Up to 18 weeks||||participants|||Number
1359146|NCT01688609|Primary|Number of Participants With Pathological Complete Response (pCR)|The point estimate of the pCR rate will be calculated for all patients. pCR is defined as the abscence of invasive cancer in the breast and regional lymph nodes following neoadjuvant chemotherapy.|Up to 12 weeks||||Participants|||Count of Participants
1359147|NCT01688609|Primary|Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks|For biomarkers ALDH1 and CD44v, the change in the proportions of CD44v-positive (CD44v+) tumor cells and ALDH1-positive (ALDH1+) tumor cells in tumor tissue from baseline to 6 weeks and 18 weeks time points were determined for each patient. For biomarker change, changes in the binary biomarkers between time points were assessed using McNemar’s test in all patients and separately in patients with and without pCR.|From baseline to 18 weeks||||Participants|||Count of Participants
1359148|NCT01688466|Secondary|Toxicity|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|50 months and 20 days||||Participants|||Count of Participants
1359149|NCT01688466|Primary|Overall Response at 6 Months|Overall response was assessed by the National Institutes of Health (NIH) Chronic Graft-Versus Host Disease (cGVHD) Response criteria. Complete response (CR) is complete resolution in all signs and symptoms at all affected organs or tissues. Partial response (PR) is improvement in ≥ 1 organ or tissue with no progression in any other affected organ or tissue. Response < PR is a change towards improvement from the pre-treatment baseline but not meeting the criteria for CR or PR. Stable disease (SD) is no change in cGVHD. Flare is exacerbation of cGVHD manifestations during withdrawal of immunosuppressive therapy which do not exceed those at the beginning of the trial and improves after reinstatement of previous treatment. Progressive disease (PD) is failure of therapy to control cGVHD . Mixed response (improvement in some organs but worsening in others) will be categorized as progressive disease.|6 months||||Participants|||Count of Participants
1359150|NCT01688336|Other Pre-specified|Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).|Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).|Up to 3 years|Data were not collected||||||
1359151|NCT01688336|Secondary|Rate of Resectability (RR)|Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
1359177|NCT01688050|Primary|Device Success|Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.|30 days|One patient had device compression (counted as a failure conservatively although the compression was not consistent with collapse of the proximal end of the device) and one patient had a site-reported Type I endoleak requiring secondary intervention.|||participants|||Number
1359152|NCT01688336|Secondary|Disease Control Rate (DCR)|Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
1359153|NCT01688336|Secondary|Objective Response Rate|"All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically."|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
1359154|NCT01688336|Secondary|Progression Free Survival (PFS)|Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored|the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years||||Months||95% Confidence Interval|Median
1359155|NCT01688336|Secondary|Overall Survival for Borderline Resectable Patients|All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)|Up to 3 years||||Months||95% Confidence Interval|Median
1359156|NCT01688336|Primary|Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer|All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).|Up to 3 years|Patients with unresectable locally advanced pancreatic cancer.|||months||95% Confidence Interval|Median
1359157|NCT01688310|Other Pre-specified|Adverse Events|Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 yr||||participants|||Number
1359158|NCT01688310|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).|Within 6 weeks after surgery||||participants|||Number
1359159|NCT01688310|Secondary|Overall Patient Satisfaction|Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.|Within 6 weeks after surgery||||participants|||Number
1359160|NCT01688310|Secondary|Pain Experienced|Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)|2 days after surgery||||units on 10 point pain scale||Standard Deviation|Mean
1359161|NCT01688310|Secondary|Direct Costs|the cost of labor, supplies and equipment|Within 6 weeks after surgery|||||||
1359162|NCT01688310|Secondary|Time Required for Healing|Time required for healing|Within 6 weeks after surgery||||percentage of participants|||Number
1359163|NCT01688310|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey, 5 point Likert scale:~Gomco technique is much easier~Gomco technique is easier~Neutral~Open surgical technique is easier~Open surgical technique is much easier"|1 year||||units on Likert scale||Full Range|Median
1359164|NCT01688310|Primary|Intraoperative Duration|Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.|1 year|All participants|||Min||Standard Deviation|Mean
1359165|NCT01688102|Other Pre-specified|Gene Expression Changes in Skin|Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.|baseline vs. 2 months||||GSEA Normalized Enrichment Score|||Number
1359166|NCT01688102|Other Pre-specified|Gene Expression Changes in Peripheral Blood|Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.|baseline vs. 2 months||||GSEA Normalized Enrichment Score|||Number
1359167|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in PTH||2 months||||Pearson correlation coefficient|||Number
1359168|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in Calcium|The Correlation between change in LDL cholesterol and change in serum calcium|2 months||||Pearson correlation coefficient|||Number
1359169|NCT01688102|Secondary|Change in Parathyroid Hormone (PTH)||baseline vs.6 months||||pg/mL||Standard Deviation|Mean
1359170|NCT01688102|Secondary|Change in Serum Calcium||baseline vs. 6 months||||mg/dL||Standard Deviation|Mean
1359171|NCT01688102|Secondary|Change in 25(OH)D||baseline vs. 6 months|Data only for those who completed 6 months of therapy|||ng/ml||Standard Deviation|Mean
1359172|NCT01688102|Secondary|Change in C Reactive Protein||baseline and 6 months|Data analyzed are only for those who completed 6 months of therapy|||mg/L||Standard Deviation|Mean
1359173|NCT01688102|Secondary|Change in Triglycerides||baseline 6 months or last observation carried forward (minimum 2 months)||||mg/dL||Standard Deviation|Mean
1359174|NCT01688102|Secondary|Change in HDL Cholesterol||baseline and 6 months or last observation carried forward (minimum 2 months)||||mg/dL||Standard Deviation|Mean
1359175|NCT01688102|Secondary|Change in Total Cholesterol|Change in Total Cholesterol|baseline and 6 months or last observation carried forward (minimum 2 months)||||mg/dL||Standard Deviation|Mean
1359180|NCT01688037|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 2|ITT analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at Week 2).|||units on a scale||Standard Error|Least Squares Mean
1359181|NCT01688037|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD)|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse). The ANOVA analysis of CGI-TD was conducted for the pooled NBI-98854 50+100 mg group and placebo group.|Week 6|ITT analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at either Week 2 or Week 6).|||units on a scale||Standard Error|Least Squares Mean
1359182|NCT01688037|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI-98854 50+100 mg group and placebo group analyzed using the ANCOVA model (LOCF, ITT analysis set).|Baseline and Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at either Week 2 or Week 6). Last observation carried forward (LOCF) imputation method.|||units on a scale||Standard Error|Least Squares Mean
1359183|NCT01687998|Secondary|Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
1359184|NCT01687998|Secondary|Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
1359185|NCT01687998|Secondary|Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
1359186|NCT01687998|Secondary|Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
1359187|NCT01687998|Secondary|Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels||Baseline, 3 Months|All randomized participants with evaluable LDL-C and HDL-C levels.|||percent||Standard Deviation|Mean
1359188|NCT01687998|Primary|Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline to Study Completion (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
1359189|NCT01687972|Primary|Closure Time|Number of minutes taken to close post cesarean section|up to 20 minutes post intervention|Data was not collected for all participants enrolled|||minutes||Full Range|Mean
1359190|NCT01687972|Primary|Patient Scar Assessment Scale (PSAS)|assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.|6 weeks|Data was unable to be collected from all participants randomized due to lack of follow-up post intervention.|||units on a scale||Full Range|Mean
1359191|NCT01687972|Primary|Patient Pain Scale|Visual Analog Score 0-10, with 0 being painless and 10 being the most severe|3 months|Data was not collected for all participants enrolled due to failure to follow-up post intervention.|||units on a scale||Full Range|Mean
1359192|NCT01687790|Secondary|Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.|Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).|1 year|Analysis population included the number of indeterminate lesions that had positive pathology results.|||lesions|||Number
1359193|NCT01687790|Primary|Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.|The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).|1 year|Analysis population included the number of indeterminate lesions that had negative/benign pathology results.|||lesions|||Number
1359194|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.|||Participants|||Count of Participants
1361885|NCT01661595|Other Pre-specified|Hematocrit Level Was Measured at 4 Weeks|Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.|4 weeks||||percent of red blood cells||Standard Deviation|Mean
1359195|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.|||Participants|||Count of Participants
1359196|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.|||Participants|||Count of Participants
1359197|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
1359198|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
1359199|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
1359200|NCT01687712|Secondary|Overall Summary of Adverse Events (AEs) - Cycle 1|"Summary of AEs, including the number of subjects experiencing to following during Cycle 1:~At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication"|Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
1359201|NCT01687712|Secondary|Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1|Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction|Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
1359202|NCT01687712|Secondary|Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1|Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.|Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
1359203|NCT01687712|Secondary|Number of Oocytes Retrieved - Cycle 1|The number of oocytes retrieved per subject, following hCG administration in Cycle 1.|Visit 8, 34-36 hours after hCG administration|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Oocytes retrieved||Standard Deviation|Mean
1359204|NCT01687712|Secondary|Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1|The mean dose of r-hFSH that subjects received in a day during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts.|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||international unit (IU)||Standard Deviation|Mean
1359205|NCT01687712|Secondary|Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1|The total dose of r-hFSH that subjects received during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts.|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||international unit (IU)||Standard Deviation|Mean
1359206|NCT01687712|Secondary|Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1|The number of days of r-hFSH stimulation a subject received during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||days||Standard Deviation|Mean
1359207|NCT01687712|Primary|Clinical Pregnancy Rate After One Cycle of Treatment - PP Population|Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.|Six weeks post embryo transfer|Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment).|||Participants|||Count of Participants
1359208|NCT01687712|Primary|Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population|Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.|Six weeks post embryo transfer|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
1359209|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)|AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant’s incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
1359210|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)|BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient’s awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
1359211|NCT01687478|Secondary|Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks|The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.|Baseline, 8 Weeks|All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Percent of participants|||Number
1359212|NCT01687478|Secondary|Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score|The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.|Baseline,8 Weeks|All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Percent of participants|||Number
1359213|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)|SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.|Baseline, 8 Weeks|All randomized participants.|||Units on a scale||Standard Error|Mean
1359214|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)|SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.|Baseline, 8 Weeks|All randomized participants.|||units on a scale||Standard Deviation|Mean
1359215|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)|SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
1359216|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale|CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.|Baseline, 8 Weeks|Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Units on a scale||Standard Error|Least Squares Mean
1359217|NCT01687478|Primary|Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)|The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.|Baseline, 8 Weeks|Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Units on a scale||Standard Error|Least Squares Mean
1359218|NCT01687296|Secondary|Mean Global Evaluation for Efficacy by Participant/Parent and Investigator|At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis.|Day 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1359219|NCT01687296|Secondary|Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8|The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3|Baseline, Day 5 and Day 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1359220|NCT01687296|Secondary|Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period|Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment.|During the treatment period at Day 5, Day 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Litres||Standard Error|Least Squares Mean
1359221|NCT01687296|Secondary|Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period|The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period.|Days 2 to 8|ITT Population. Data is presented for the participants available at the time of assessment.|||Number of use of rescue medication||Full Range|Median
1359222|NCT01687296|Secondary|Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period|The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period.|Days 2 to 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Full Range|Median
1359223|NCT01687296|Secondary|Mean Evening PEF on Diary Card Over the Treatment Assessment Period|PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group.|Days 1/2 to 8|ITT Population. Data is presented for the participants available at the time of assessment.|||L/min||Standard Error|Least Squares Mean
1359224|NCT01687296|Primary|Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population|PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group.|Days 2 to 8|PP Population comprised of all participants in the ITT Population who did not have any full protocol violations which could impact treatment effect. Data is presented for the participants available at the time of assessment.|||L/min||Standard Error|Least Squares Mean
1359726|NCT01682603|Primary|Net Change of the Quality of Life Index (QoL-I)|"Efficacy:~Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 Delighted to 6 Terrible. The QoL-I ranges 0 to 6~Safety:~Systemic adverse events"|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1359225|NCT01687296|Primary|Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population|PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group.|Days 2 to 8|ITT Population comprised of all participants randomized to treatment and who received at least one dose of study drug. Data is presented for the participants available at the time of assessment.|||Litres per minute (L/min)||Standard Error|Least Squares Mean
1359226|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-area Under the Plasma Concentration-time Curve for the Dose Interval [AUC (0-τ)]|AUC (0-τ) was defined as the area under the plasma concentration-time curve for the dose interval. Blood PK samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of last dose.|Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetic population. Only those participants available at the indicated time points were analyzed.|||Picogram hours per milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1359227|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-maximum Observed Plasma Concentration (Cmax)|Cmax was defined as maximum observed plasma concentration. Blood PK samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of last dose.|Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetic population. Only those participants available at the indicated time points were analyzed.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1359228|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution- Time to Maximum Observed Plasma Concentration (Tmax)|Tmax is defined as the time to maximum observed plasma concentration. Blood Pharmacokinetic (PK) samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of the last dose.|Pre-dose, 0.5 hour (h), 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetics population included all participants whose PK samples were obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||Hour||Geometric Coefficient of Variation|Geometric Mean
1359229|NCT01687283|Secondary|Change of Clinical Lung Function Measurement Forced Expiratory Volume in One Second (FEV1) From Baseline Over 12 Weeks|FEV1 as a measure of lung function assessment was measured at Week 2, 4, 8 and 12. FEV1 measures were performed electronically by spirometry. The highest of three technically acceptable measurements was recorded. FEV1 was measured prior to study drug administration and any rescue salbutamol use. Baseline value was the assessment at Visit 2.Change from baseline was calculated as the value at the specific time point minus baseline value.|Baseline and at Week 2, 4, 8 and 12|Intent-to-treat population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Litres||Standard Error|Least Squares Mean
1359230|NCT01687283|Secondary|Median Number of Times Rescue Medication Use Over 12 Weeks|Participants recorded the number of inhalations of rescue salbutamol inhalation aerosol used during the day and night. The baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. The analysis only included participants who had at least 2 days of non-missing numbers of times rescue medication (including zero) after randomization.|Up to week 12|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Number of Inhalations||Full Range|Median
1359231|NCT01687283|Secondary|Mean Change in Percentage of Rescue-free 24-hour Periods From Baseline Over 12 Weeks|While calculating rescue-free 24-hour periods, the 24-hour period was only set to be “rescue free” if responses to both the morning and evening, assessments indicated no use of rescue medication. If there were symptoms in either the morning or the evening then that 24-hour period was set to as “not symptom free”. Similarly, if there was rescue medication use in either the morning or the evening, then that 24-hour period was set to as “not rescue free”. The Baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. The value provided in outcome measure data is a consolidated value over Weeks 1 to 12.|Baseline and over 12 weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Percentage of rescue -free 24-hours||Standard Error|Least Squares Mean
1359232|NCT01687283|Secondary|Median Day-time and Night-time Symptom Scores Per Participant Over 12 Weeks|Participants recorded day-time symptom score every day in the morning and evening at bedtime before taking any rescue or study medication and before PEF measurement, using 6 point scale on Diary Card indicating 0 = No symptoms during the day and 5 =Symptoms so severe that participant could not go to work or perform normal daily activities. Night time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). The value provided in outcome measure data is a consolidated value over Weeks 1 to 12.|Over 12 Weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Score on Scale||Full Range|Median
1359233|NCT01687283|Secondary|Mean Change in Percentage of Symptom-free 24-hour Periods From Baseline Over 12 Weeks|While calculating symptom-free 24-hour periods, a given 24-hour period was set to be “symptom free” only if the participant’s responses to both the morning and evening assessments indicated no symptoms. The Baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. Change from Baseline was calculated as the difference between the value of the endpoint at the time point of interest and the baseline value. The value provided in outcome measure data is a consolidated value over Weeks 1 to 12.|Baseline (Visit 2) and over 12 Weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Percentage of symptom-free 24-hour||Standard Error|Least Squares Mean
1359234|NCT01687283|Secondary|Mean Change of Evening PEF From Baseline Over 12 Weeks|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the evening PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily PM PEF averaged over the 12-weeks treatment period.|Baseline (Visit 2) and up to Week 12|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Litres/Minute||Standard Error|Least Squares Mean
1359235|NCT01687283|Primary|Change From Baseline (Day 1 of Trt Period/Visit 2) in AM PEF Over 12 Weeks in Per Protocol Population|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the morning PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily AM PEF averaged over the 12-week treatment period The mean value was considered missing if less than 4 days were recorded in the baseline week prior to randomization or if less than 4 days are recorded after randomization. Analysis was performed using analysis of covariance (ANCOVA) model.|Baseline (Visit 2) and up to Week 12|Per protocol population. This population comprised of all participants in the intent-to-treat Population who did not have any protocol violations which could impact treatment effect.Only those participants available at the specified time points were analyzed.|||Litres/Minute||Standard Error|Least Squares Mean
1359236|NCT01687283|Primary|Change From Baseline (Day 1 of Treatment Period/Visit 2) in Morning Peak Expiratory Flow (AM PEF) Over 12 Weeks in Intent-to-treat Population|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the morning PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily AM PEF averaged over the 12-week treatment period The mean value was considered missing if less than 4 days were recorded in the baseline week prior to randomization or if less than 4 days are recorded after randomization. Analysis was performed using analysis of covariance (ANCOVA) model. Abbreviations used in statistical analysis section: standard deviation (SD) and significance (sig)|Baseline (Visit 2) and up to Week 12|Intent-to-treat population. Only those participants available at the specified time points were analyzed.|||Litres/Minute||Standard Error|Least Squares Mean
1359237|NCT01687270|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment~Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1359238|NCT01687270|Secondary|HCV RNA and Change From Baseline at Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1359239|NCT01687270|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24||Weeks 12 and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1359240|NCT01687270|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4, 24, and 48|Full Analysis Set|||percentage of participants|||Number
1359241|NCT01687270|Primary|Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event||Baseline to Week 24|Safety Analysis Set|||percentage of participants|||Number
1359242|NCT01687270|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were enrolled and received at least one dose of study medication.|||percentage of participants|||Number
1359243|NCT01687257|Secondary|Change From Baseline in Model for End Stage Liver Disease (MELD) Scores|"MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20.~Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.|||percentage of participants|||Number
1359244|NCT01687257|Secondary|Change From Baseline in Child-Pugh-Turcotte (CPT) Score|"CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline.~Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.|||percentage of participants|||Number
1359360|NCT01685840|Secondary|EQ-5D Health Index|The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359245|NCT01687257|Secondary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment|HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug.|Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)|Participants who were randomized to the study with available data at baseline and end of observation or end of treatment were analyzed.|||mmHg||Standard Deviation|Mean
1359246|NCT01687257|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.|||percentage of participants|||Number
1359247|NCT01687257|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 48 weeks|Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1359248|NCT01687257|Secondary|Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 24, and 48|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.|||percentage of participants|||Number
1359249|NCT01687257|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period.|Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)|Participants who were randomized to the study.|||percentage of participants|||Number
1359250|NCT01687244|Secondary|Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.|The levels of serum anti-adenovirus type 5 antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported at Number of Patients with a Positive Titer.|||Participants|||Count of Participants
1359251|NCT01687244|Secondary|Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum|The levels of serum anti-IFN alpha2b antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported at Number of Patients with a Positive Titre.|||Participants|||Count of Participants
1359252|NCT01687244|Secondary|Number of Patients With Elevated IFN alpha2b Protein Levels in Urine|The levels of urine IFN alpha2b protein as measured by ELISA were measured in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that did not have recurrence of HGD and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as the number of patients with elevated levels of IFN alpha2b levels in urine.|||Participants|||Count of Participants
1359253|NCT01687244|Secondary|Number of Patients With Elevated IFN alpha2b Protein Levels in Serum|The levels of serum IFN alpha2b protein as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 91 (pre-dose), Day 92, Day 94, Day 103, Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported as the number of patients with increased levels of IFN alpha2b protein in serum.|||Participants|||Count of Participants
1359254|NCT01687244|Secondary|Number of Patients With Elevated Levels of Viral Vector in Urine|The level of viral vector as measured by qPCR in urine was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as number of patients demonstrating increased levels of viral vector by qPCR in urine.|||Participants|||Count of Participants
1359255|NCT01687244|Secondary|Number of Patients With Elevated Levels of Viral Vector in Blood|The level of viral vector as measured by qPCR in blood was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as number of patients demonstrating viral vector by qPCR in blood.|||Participants|||Count of Participants
1359256|NCT01687244|Secondary|Overall Survival in All Patients.|Overall survival was defined as the number who survived from the first dose of rAd-IFN/Syn3 to the end of the primary assessment (360 Days) or Withdrawal.|360 Days|The data are presented as the number of patients who survived the study (360 Days). All patients were monitored for this endpoint.|||Participants|||Count of Participants
1359257|NCT01687244|Secondary|Incidence of Cystectomy in All Patients|This secondary objective measures the incidence of cystectomy at 360 Days for the Efficacy Analysis Set.|360 Days|The data are presented as the number of patients per dose group having a cystectomy during the 360 days of the study.|||Participants|||Count of Participants
1359258|NCT01687244|Secondary|Incidence of High Grade-Recurrence-Free Survival at 9 Months (270 Days).|All patients were evaluated 9 Months (270 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received a final dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|270 Days|All patients that received a dose at Day 180 were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.|||Participants|||Count of Participants
1359259|NCT01687244|Secondary|Incidence of High Grade-Recurrence-Free Survival at 6 Months (180 Days).|All patients were evaluated 6 Months (180 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|180 Days|All patients receiving a dose at 90 Days were assessed at 180 Days for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.|||Participants|||Count of Participants
1359260|NCT01687244|Secondary|Incidence of High Grade Recurrence-Free Survival at 3 Months (90 Days).|All patients were evaluated 3 Months (90 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|90 Days|All patients at 90 Days were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.|||Participants|||Count of Participants
1359261|NCT01687244|Secondary|Safety of rAd-IFN/Syn3|Treatment Emergent Adverse Events (AEs) for patients receiving study drug were described by NCI-CTCAE V4.03 terminology according to System Organ Class.|360 Days||||Participants|||Count of Participants
1359262|NCT01687244|Primary|Incidence of High Grade-Recurrence Free Survival at 360 Days|Following the initial treatment, patients were clinically evaluated and re-treated at the Days 90, 180, and 270 time points, as outlined below. The decision to repeat treatment was determined by the clinical response observed following the previous treatment(s). Patients were assessed for High-Grade disease recurrence by cytology, cystoscopy and, if clinically indicated, biopsies were performed to obtain accurate staging. If no evidence of recurrence of High-Grade disease was detected, then a further dose of rAd-IFN/Syn3 was administered as maintenance therapy. Patients who had recurrence of High-Grade disease were withdrawn from treatment but were followed for survival and time to cystectomy. At 360 Days, a final efficacy evaluation was performed for patients receiving 4 doses of drug. This included cystoscopy, cytology, and biopsy.|360 Days||||Participants|||Count of Participants
1359263|NCT01687218|Other Pre-specified|Problem Practices|To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359264|NCT01687218|Other Pre-specified|Product Sharing|To determine the level of sharing of study products with non-participants and to assess with whom products are shared|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359265|NCT01687218|Other Pre-specified|Sexual Activity and Condom Use|To examine whether sexual activity or condom use varies by product used|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359266|NCT01687218|Other Pre-specified|Factors Associated With Adherence|To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359267|NCT01687218|Other Pre-specified|Correlation Between PK and Adherence|To assess correlation of PK with adherence measures|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359268|NCT01687218|Other Pre-specified|Mucosal Immunity|To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359269|NCT01687218|Other Pre-specified|Pharmacodynamics|To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359270|NCT01687218|Secondary|Adherence|To evaluate and compare adherence to daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. The Behavioral Research Working Group provided the final adherence estimate of the percentage of prescribed doses taken for each participant for each period based on participant self-report, staff estimates and PK testing results.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All secondary analyses are based on the data from evaluable participants|||participants|||Number
1359271|NCT01687218|Secondary|Pharmacokinetics|To compare systemic and local PK among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
1359272|NCT01687218|Primary|Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.|||participants|||Number
1359273|NCT01687218|Primary|Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.|||participants|||Number
1359389|NCT01685567|Secondary|All Myocardial Infarctions (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days||||Participants|||Count of Participants
1359274|NCT01687218|Primary|Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.|||participants|||Number
1359275|NCT01687218|Primary|Safety: Grade 2 or Higher Adverse Events|Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Among the 187 evaluable participants. One participant was terminated before the Initiate Period visit of his/her Period 3 (Oral Tablet regimen period). Thus, this participant is removed from the analysis of the oral period regimen.|||participants|||Number
1359276|NCT01687166|Secondary|Acute Success|Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.|Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation||||Participants|||Count of Participants
1359277|NCT01687166|Primary|Chronic Success Rate|"The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.~*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure."|Within 12 months of the index procedure||||Participants|||Count of Participants
1359278|NCT01687166|Primary|Procedure-related Complication Free Rate|"The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.~The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group."|12 Months||||Participants|||Count of Participants
1359279|NCT01687114|Primary|Proanthocyanidin A2|proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.|24-hour urine and morning spot urine|The subjects included 5 generally healthy premenopausal women, age 20-40 y, with a body mass index (BMI) ranging from 18.5 to 25 kg/m2. The specific operational criteria used to assess eligibility included: age, BMI, premenopausal status, not pregnant or planning to become pregnant.|||ng/mg creatinine||Standard Deviation|Mean
1359280|NCT01687101|Primary|Efficacy of STOPAIN in the Acute Treatment of Migraine|"To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to no pain) at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain)."|2 hours after the time of gel application||||units on a scale||Full Range|Mean
1359281|NCT01687088|Primary|Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points|"Migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. The UPSIT test is a series of 40 questions and the score is the number of questions answered correctly. Each question is multiple choice and must be answered. The number of correct answers regarding the smells being experienced is the subjects score. The higher the score the better the sense of smell. This allows groups to be compared. In this study after the first visit, migraineurs will be given the UPSIT test without a headache and then they will self-administer the UPSIT during a migraine attack day at home.~Age and sex matched controls will also take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home."|Chronic migraineurs up to 12 months. Controls up to 2 weeks.||||UPSIT Score||Standard Error|Mean
1359282|NCT01687036|Secondary|AE|18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013||||participants|||Number
1359283|NCT01687036|Secondary|Cumulative Cryoablation Time|"Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.~Average cryoablation time was 114 min. 33 sec. (range 80 – 130 min.)."|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013||||minutes||Standard Deviation|Mean
1359284|NCT01687036|Secondary|Fluoroscopy Time|"Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.~Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. – 59 min.)."|Treatment Duration||||minutes||Standard Deviation|Mean
1359285|NCT01687036|Secondary|Procedure Time|Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.|Average procedure time: 251 min. 06 sec. (range 126 – 320 min.)||||minutes||Standard Deviation|Mean
1359286|NCT01687036|Secondary|Clinical Efficacy of Catheter Ablation|During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013||||participants|||Number
1359287|NCT01687036|Secondary|Acute Efficacy of Catheter Ablation|Absolute percentage of PVs isolated with the CoolLoop® catheter.|Treatment Duration||||percentage of isolated PVs|||Number
1359288|NCT01687036|Secondary|Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.|Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.|Treatment Duration||||participants|||Number
1359289|NCT01687036|Primary|Tolerability of Ablation Using the AFreeze Cryoablation System|"The primary study objective is assessed by recording all Adverse Events (AEs).~Primary endpoint: measurement of the following parameters:~- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment)."|Treatment Duration||||AE (device related)|||Number
1359290|NCT01687036|Primary|Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)|"The primary study objective is assessed by recording all Serious Adverse Events (SAEs).~Primary endpoint: measurement of the following parameters:~deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).~phrenic nerve palsy during visit 3 (treatment).~onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.~onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention."|3 months||||participants|||Number
1359291|NCT01686932|Secondary|Number of Occurrence of Pre-defined ECG Findings During 4 Days of Continuous ECG Monitoring at Baseline and in the 8th Week of Periods 1 and 2|Number of Occurrence of pre-defined ECG findings during 4 days of continuous ECG monitoring at baseline and in the 8th week of Periods 1 and 2. ECG data were continuously recorded and analyzed over a period of 4 days simultaneously with continuous glucose monitoring. It assessed number of any Vertical Electric(al) Sounding (VES), number of 2 consecutive VES [couplets], and number of >3 consecutive VES [salves]|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||number of occurrence||Standard Deviation|Mean
1359292|NCT01686932|Secondary|Percentage Change From Baseline of Pro-insulin/C-peptide Ratios After 8 Weeks of Treatment Period 1 & Period 2|Percentage Change from baseline of pro-insulin/C-peptide ratios after 8 weeks of treatment Period 1 & Period 2 Higher pro-insulin / C-peptide ratios (expressing disproportional hyperproinsulinemia) may be associated with increasing beta cell dysfunction and more inefficient pro-insulin processing|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||Percentage Change||Standard Deviation|Mean
1359293|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers Interleukin 6 (IL-6) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers IL-6 was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||pg/L||Standard Deviation|Mean
1359294|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers High Sensitivity C-reactive Protein (hsCRP) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers hsCRP was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mg/L||Standard Deviation|Mean
1359295|NCT01686932|Secondary|Number of Participants With ECG Abnormalities Depending on Hypoglycemic Events After 8 Weeks of Treatment Period 1 & Period 2|ECG abnormalities are defined as either: • Occurrence of >30 ventricular extrasystoles (VES) per hour or • Occurrence of ≥2 consecutive VES (Couplets) or • Occurrence of ≥3 consecutive VES (Triplets) or • QT-time corrected for heart rate (QTc) >440 ms. after 8 weeks of treatment Period 1 & Period 2|after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||participants|||Number
1359296|NCT01686932|Secondary|Glucose Fluctuations During the Day Under Vildagliptin Treatment Compared to Sitagliptin Treatment on Day 2 After 8 Weeks of Treatment Period 1 & Period 2|Glucose fluctuations are assessed by the mean amplitude of glycemic excursions (MAGE) and standard deviations (SD) (Service et al., 1970). on day 2 after 8 weeks of treatment Period 1 & Period 2|Day 2 after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mmol/L||Standard Deviation|Mean
1359297|NCT01686932|Secondary|Number of Severe Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment After 8 Weeks of Treatment in Period 1 and Period 2|Severe hypoglycemic events are defined as any episode requiring the assistance of another party or measured plasma glucose levels of <40 mg /dL. Assessed by self-monitored blood glucose (SMBG)After 8 weeks of treatment in Period 1 and Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||severe hypoglycemic events|||Number
1359298|NCT01686932|Secondary|Mean Amplitudes of Hypoglycemic Events (mmol/L) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|To evaluate by CGM measurement the grade of severity of hypoglycemia measured as the mean amplitude over 4 days after 8 weeks of treatment in Period 1 & Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mmol/L||Standard Deviation|Mean
1359299|NCT01686932|Secondary|Mean Duration of Hypoglycemic Events (Min.) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|the mean duration of hypoglycemic events is detected by continuous glucose monitoring (CGM)measurement.|after 8 weeks for Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||minutes||Standard Deviation|Mean
1359300|NCT01686932|Secondary|Number of Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment.|Hypoglycemic events are defined as blood glucose values <70 mg/dL measured by a self-monitored blood glucose (SMBG) or continuous glucose monitoring (CGM) measurement regardless of any symptoms suggestive of low blood glucose.|after 8 weeks period 1 and Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||number of hypoglycemic events|||Number
1379750|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)|||||||
1359301|NCT01686932|Primary|Hypoglycemic Profile of Vildagliptin Compared to Sitagliptin Over 4 Days After 8 Weeks of Treatment in Period 1 & 2|The hypoglycemic profile is defined as the area under the curve glucose-time profile obtained by continuous glucose monitoring Interstitial glucose values below 3.9 mmol/L (averaged over 5 minutes) were considered relevant for the estimation of the interstitial glucose AUC in the hypoglycemic range These AUC<3.9mmol/L/5min. values were summed up over 4 days (unit: mmol/L/4d) or over 24 hours at measurement Days 2, 3, 4, and 5 (unit: mmol/L/24h). Lower values for AUC reflect less intense hypoglycemia.|baseline and 0-24 hours post-dose on Days 2 to 5|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mmol/L/4d||Standard Deviation|Mean
1359302|NCT01686828|Secondary|Changes in Adipose Tissue Gene Expression|We examined whether differences in lipoprotein lipase expression would be evident across study treatment groups. RNA was isolated from whole adipose tissue gene expression, and complementary DNA (cDNA) was synthesized from 1.5 ug of RNA per sample. Gene expression was measured by polymerase chain reaction (PCR) using predesigned TaqMan® Gene Expression Assays. Standard curves were included on each plate, so Ct values were converted to copy numbers of the target gene. Expression values were normalized to the geometric mean of the housekeeping genes phosphoglycerate kinase and 18s.|4 weeks|Subjects were included who had adipose tissue samples available from both baseline and week 4 (end-of-treatment) visits.|||gene copy number per ng RNA||Standard Deviation|Mean
1359303|NCT01686828|Secondary|Changes in Body Composition|Fat mass and lean mass were measured by dual energy X-ray absorptiometry (DEXA) at baseline and at the end of the 4 week treatment period|4 weeks||||kg||Standard Deviation|Mean
1359304|NCT01686828|Primary|Insulin Sensitivity Quantified by Matsuda Index|Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*2+PG90*2+PG120)/8*(FPI+PI30*2+PI60*2+PI90*2+PI)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60,90, and 120 minutes after oral glucose load; PI30,60,90, and 120=plasma insulin levels sampled at 30,60,90, and 120 minutes after the oral glucose load|4 weeks|Of the 53 subjects who attended the baseline study visit, 2 withdrew from the study and 1 was discontinued due to a protocol violation. 50 subjects completed the week 10 study visit. Of these, 5 subjects were excluded from the final analyses; 1 was found to have undiagnosed diabetes, and 4 subjects were excluded due to study drug non-adherence.|||units on a scale||Inter-Quartile Range|Median
1359305|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the Divided Attention task, participants were required to respond on hearing the no. ‘8’ in a continuous stream of numbers through headphones or seeing a letter ‘s’ on screen. This was identified in the output file by a value of ‘8’ in ‘NUMBER’ column or ‘s’ in ‘LETTER’ column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of ‘-1’ in ‘CORRECT=1’ column. The number of incorrect responses was calculated as the total no. of records where ‘CORRECT=1’ had a value of ‘-1’. If the subject missed a target (failed to press the response button on hearing the no. ‘8’ or seeing the letter ‘s’), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of ‘8’ in ‘NUMBER’ column or ‘s’ in ‘LETTER’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||incorrect and missed responses||Standard Error|Mean
1359306|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Least Squares Mean
1359307|NCT01686646|Secondary|Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number ‘8’ in a continuous stream of numbers presented through headphones or saw a letter ‘s’ on the screen . This was identified in the output file by a value of ‘8’ in the ‘NUMBER’ column or by a value of ‘s’ in the ‘LETTER’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Full Range|Median
1359308|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|For sustained auditory attention task, participants were required to respond on hearing the no. ‘8’ in a continuous stream of numbers through headphones. It was identified in output file by a value of ‘8’ in ‘NUMBER’ column. For sustained visual attention task, participants responded to letter ‘s’ every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of ‘s’ in ‘LETTER’ column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of ‘-1’ in ‘CORRECT=1’ column. The no. of incorrect responses was calculated as total no. of records where ‘CORRECT=1’ had a value of ‘-1’. The no. of missed responses (when subject failed to press the response button on hearing the number ‘8’ or seeing the letter ‘s’), was calculated as the no. of records where there was a value of ‘8’ in ‘NUMBER’ column or ‘s’ in the ‘LETTER’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||incorrect and missed responses||Standard Error|Mean
1359390|NCT01685567|Secondary|All Death (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days||||Participants|||Count of Participants
1359309|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Least Squares Mean
1359310|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number ‘8’ in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of ‘8’ in the ‘NUMBER’ column. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of ‘s’ in the ‘LETTER’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Full Range|Median
1359311|NCT01686646|Secondary|Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task|The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of ‘1’ in the ‘TARGET=1’ column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of ‘-1’ in the ‘CORRECT=1’ column. The no. of incorrect responses was calculated as the total no. of records where ‘CORRECT=1’ had a value of ‘-1’. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of ‘1’ in the ‘TARGET=1’ column and a value of ‘0’ in the ‘CORRECT=1’ column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||inaccurate and missed responses||Standard Error|Mean
1359312|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with ‘1’ in the ‘CORRECT=1’ column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with ‘1’ in the ‘CORRECT=1’ column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and upto 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||milliseconds (msec)||Full Range|Median
1359313|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of ‘1’ in ‘TARGET=1’ column. Also, the response time (in seconds) was recorded in the ‘RT’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Standard Error|Least Squares Mean
1359314|NCT01686646|Primary|Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of ‘1’ in ‘TARGET=1’ column. Also, the response time (in seconds) was recorded in the ‘RT’ column. If the subject correctly responded to the target, this was identified by a value of ‘1’ in the ‘CORRECT=1’ column. The number of accurate responses was calculated as the total number of records where ‘CORRECT=1’ had a value of ‘1’. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Standard Error|Least Squares Mean
1359323|NCT01686568|Secondary|Macrophage Crown-like Structures|Macrophages surrounding dying or dead adipocytes form crown-like structures (CLSs). One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess the number of crown-like structures per 10 images.|approximately after 6 months of treatment||||crown-like structures per 10 images||Inter-Quartile Range|Median
1359601|NCT01683604|Secondary|Duration of Tocilizumab Treatment||Baseline up to Month 6|FAS population.|||days||Standard Deviation|Mean
1359315|NCT01686633|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1359316|NCT01686633|Secondary|Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1359317|NCT01686633|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1359318|NCT01686633|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1359319|NCT01686633|Secondary|Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on-treatment. Change from Baseline in trough FEV1 at the end of the 12-week treatment period was defined using the 24-hour post-dose serial FEV1 measurement taken at the Week 12 clinic visit. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 12|ITT Population. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
1359320|NCT01686633|Primary|Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 84/Week 12 minus the Baseline value. Baseline was the pre-dose FEV1 measurement value obtained at Visit 3. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and Week 12 weighted mean data were analyzed.|||Liters||Standard Error|Least Squares Mean
1359321|NCT01686568|Post-Hoc|EPA and DHA Concentrations in Adipose Tissue|Post hoc analyses were conducted to test whether EPA and DHA concentrations in subcutaneous abdominal adipose tissue in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.|approximately after 6 months of treatment||||percentage of total free fatty acid||Standard Error|Mean
1359322|NCT01686568|Post-Hoc|EPA and DHA Concentrations in Plasma|Post hoc analyses were conducted to test whether EPA and DHA concentrations in plasma in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.|approximately after 6 months of treatment||||percentage of total free fatty acid||Standard Error|Mean
1359343|NCT01685996|Primary|Percent Participants Abstinent From Smoking During Study Weeks 7-10|Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.|weeks 7-10||||Participants|||Count of Participants
1379751|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|26 week follow up|||||||
1359324|NCT01686568|Secondary|Immunohistochemistry Assessments of Macrophage Burden|One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess macrophage burden (total (CD68), M1 (CD14) and M2 (CD206) macrophages per 100 adipocytes).|approximately after 6 months of treatment||||macrophages per 100 adipocytes||Standard Deviation|Mean
1359325|NCT01686568|Secondary|Senescent Cells|Tissue burden of senescent cells, which was measured by staining for senescence-associated B-galactosidase activity and expressed as the number per 100 nucleated positive cells.|approximately after 6 months of treatment||||number positive cells/100 total cells||Standard Deviation|Mean
1359326|NCT01686568|Secondary|Insulin Concentration Needed to Suppress Palmitate Appearance Rates (IC50(Palmitate)f)|Sensitivity of adipose tissue lipolysis to insulin suppression, was calculated as the insulin concentration needed to suppress palmitate appearance rates (ie, flux) by 50% (IC50(palmitate)f).|approximately after 6 months of treatment|The number of subjects analyzed for this outcome measure for the placebo arm was 8 instead of 9. One subject did not have blood drawn for this outcome measure.|||µU/mL||Inter-Quartile Range|Median
1359327|NCT01686568|Secondary|Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up|Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.|Baseline, after 6 months of treatment||||pmol/s/mg tissue||Standard Error|Mean
1359328|NCT01686568|Secondary|Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up|Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.|baseline, after 6 months of treatment||||nmol/L||Standard Error|Mean
1359329|NCT01686568|Primary|Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up|A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.|Baseline, after 6 months of treatment||||mg/kg FFM/min||Standard Error|Mean
1359330|NCT01686503|Secondary|Baseline Polio Neutralizing Antibody Titers|serum polio neutralizing antibody titers prior to the vaccine booster|first visit||||antibody titers||95% Confidence Interval|Geometric Mean
1359331|NCT01686503|Primary|Post Booster Polio Neutralizing Antibody Titers|Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.|4-6 weeks after receiving the vaccine||||antibody titers||95% Confidence Interval|Geometric Mean
1359332|NCT01686451|Other Pre-specified|Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group|We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.|Measured at baseline and week 4||||number of pills|||Number
1359333|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4||||mmol/L||Standard Deviation|Mean
1359334|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4||||U/L||Standard Deviation|Mean
1359335|NCT01686451|Other Pre-specified|Comparison of XueZhiKang With Simvastatin of Physical Activity Level|At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.|Measured at baseline and week 4||||participants|||Number
1359336|NCT01686451|Primary|Comparison Between XueZhiKang and Simvastatin on Fatigue Scores|At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.|Measured at baseline and week 4||||units on a scale||Standard Deviation|Mean
1359337|NCT01686451|Secondary|Treatment Efficacy|Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.|Measured at baseline and week 4||||mmol/L||Standard Deviation|Mean
1359338|NCT01686165|Secondary|Occurrence of Adverse Events and Serious Adverse Events|The proportion of patients with a given adverse event will be tabulated and the 95% confidence interval computed.|Up to 30 days after patient receives last dose of study drug||||Participants|||Count of Participants
1359339|NCT01686165|Secondary|Progression-free Survival|Will be estimated using a Kaplan-Meier estimate. The observed 2-year progression-free survival rate will be estimated (with a 95% confidence interval) from the Kaplan-Meier curve.|2 years||||Participants|||Count of Participants
1359340|NCT01686165|Primary|Overall Response|To document the overall response for patients with relapsed aggressive high-risk non-Hodgkin’s lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen.|Up to 5 years||||Participants|||Count of Participants
1359341|NCT01686165|Primary|Complete Response Rate|To document the complete response rate for patients with relapsed aggressive high-risk non-Hodgkin’s lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen.|Up to 5 years||||Participants|||Count of Participants
1359342|NCT01685996|Secondary|Nicotine Withdrawal Symptom Severity|Total Score from the Minnesota Nicotine Withdrawal Questionnaire (MNWQ), assessed at weekly visits. The MNWQ is a commonly-used 12-item Likert scale self-report measure of nicotine symptoms. Individual symptoms were rated from 0 (none) to 4 (severe) for each item and the Total score range was 0 - 48. Ratings were collected once weekly during study visits.|Past 24 hours||||units on a scale||Standard Deviation|Mean
1359344|NCT01685983|Primary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Baseline, Month 4|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Percentage of participants|||Number
1359345|NCT01685983|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|up to 15 months|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Participants|||Number
1359346|NCT01685983|Secondary|Dehydroepiandrosterone (DHEA) Sulfate||Baseline up to 15 months|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."|||micromol per liter||Full Range|Median
1359347|NCT01685983|Secondary|Serum Testosterone|Median baseline testosterone concentration was reported at baseline.|Baseline up to 15 months|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."|||nanomole per liter||Full Range|Median
1359348|NCT01685983|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|up to 15 months|Radiographic response-evaluable population included all participants who received at least 1 dose of abiraterone acetate, and had baseline and at least 1 on treatment tumor assessment.|||Percentage of participants|||Number
1359349|NCT01685983|Secondary|Time to PSA Progression|Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.|up to 15 months|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Days||95% Confidence Interval|Median
1359350|NCT01685983|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of the first dose to the date of death.|up to 5 years|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Days||95% Confidence Interval|Median
1359351|NCT01685840|Secondary|Resource Utilization Cost|Observed Hospital-Based Cost.|24 months|US Patients with billing data|||2016 US dollars||Standard Deviation|Mean
1359352|NCT01685840|Secondary|Resource Utilization|Observed Resource Use|24 months|US Patients in Economics Substudy|||events||Standard Deviation|Mean
1359353|NCT01685840|Secondary|Short Form-36 (SF-36) Vitality Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359354|NCT01685840|Secondary|Short Form-36 (SF-36) Physiological Functioning Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359355|NCT01685840|Secondary|Short Form-36 (SF-36) Social Functioning Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359356|NCT01685840|Secondary|Short Form-36 (SF-36) Mental Health Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359357|NCT01685840|Secondary|Short Form-36 (SF-36) General Health Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359358|NCT01685840|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score|This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|Baseline, 3, 6,12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359602|NCT01683604|Secondary|Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6||Baseline, Month 6|FAS population. n= participants with available data at the specified visit.|||percentage of participants|||Number
1359361|NCT01685840|Secondary|Duke Activity Status Index (DASI)|The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
1359362|NCT01685840|Secondary|Percentage of Patients With Moderate to Severe Depression|"Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D).~CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher."|Baseline, 3,6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||percentage of participants|||Number
1359363|NCT01685840|Secondary|Number of Hospitalizations for Recurrent Heart Failure|Recurrent Heart Failure Hospitalization|24 months||||hospitalizations|||Number
1359364|NCT01685840|Secondary|Number of Hospitalizations for First Heart Failure|First Heart Failure Hospitalization|24 months||||hospitalizations|||Number
1359365|NCT01685840|Secondary|CV Death|CV death by treatment arm|24 months||||deaths|||Number
1359366|NCT01685840|Secondary|Cumulative Morbidity|Days alive and not hospitalized for CV reasons|24 months||||days||95% Confidence Interval|Mean
1359367|NCT01685840|Secondary|All-cause Mortality|All-cause mortality by treatment arm|24 months||||deaths|||Number
1359368|NCT01685840|Primary|CV Death or Heart Failure Hospitalization|Composite of First Heart Failure Hospitalization or Cardiovascular Mortality|24 Months||||events|||Number
1359369|NCT01685801|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) that started (or increased in severity) from first dose of study drug through completion of Follow-up were considered TEAEs, with exception that if an AE started during a Washout Period and was beyond 14 days from last dose date of preceding cycle, AE was considered as a “Washout Period” AE, and hence not TEAE. A TEAE was attributed to treatment in which it started or to the treatment in second cycling period of previous Crossover Period if it started during a Washout Period. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Data was to be reported by drug treatment for double-blind crossover period (Cycle 1 up to Washout Period 2) and open-label period.|From first dose of study drug through completion of follow-up visit (up to 26 weeks)|Safety set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies participant evaluable for this outcome measure.|||participants|||Number
1359370|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Weight at Day 57|Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||kilograms (kg)||Standard Deviation|Mean
1359371|NCT01685801|Secondary|Open-label Period: Absolute Change From Study Baseline In Sweat Chloride at Day 57|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Study Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||millimole per liter (mmol/L)||Standard Deviation|Mean
1359372|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Lung Clearance Index (LCI) at Day 57|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||ratio||Standard Deviation|Mean
1359373|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) at Day 57|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||Percent predicted of FEV1||Standard Deviation|Mean
1359374|NCT01685801|Secondary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Lung Clearance Index (LCI) After 2 Weeks of Treatment|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."|||ratio||Standard Deviation|Mean
1359375|NCT01685801|Primary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) After 2 Weeks of Treatment|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"Full analysis set (FAS) population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."|||Percent predicted of FEV1||Standard Deviation|Mean
1359376|NCT01685684|Secondary|Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)|The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.|Randomization Baseline and Week 12|The RMDQ was analyzed and presented as a change from Randomization Baseline to Week 12. Subjects' scores from Early Discontinuation visits were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1359377|NCT01685684|Secondary|Changes in Quality of Life|Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.|Randomization Baseline through Week 12||||units on a scale||Standard Error|Mean
1359378|NCT01685684|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes very much improved, improved, a little improved, no change, a little worse, worse, and very much worse."|Screening Baseline through Week 12||||participants|||Number
1359379|NCT01685684|Secondary|Rescue Medication Use by Dosage|Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)|Randomization Baseline through Week 12||||milligrams||Standard Deviation|Mean
1359380|NCT01685684|Secondary|Rescue Medication Usage by Dose|Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)|Randomization Baseline through Week 12||||doses||Standard Deviation|Mean
1359381|NCT01685684|Secondary|Weekly Changes in Pain Intensity|Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).|Randomization Baseline and weekly through Week 12||||units on a scale||Standard Deviation|Mean
1359382|NCT01685684|Secondary|Percent Reduction in Pain Intensity for Responders|Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.|Screening Baseline through Week 12||||participants|||Number
1359383|NCT01685684|Secondary|Time-to-exit From the Study for All Causes|Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.|Randomization Baseline through Week 12||||Days||95% Confidence Interval|Number
1359384|NCT01685684|Primary|Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase|The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).|Randomized Baseline through Week 12|One subject is missing all Average Weekly Pain Scores after Screening in the Oxycodone DETERx treatment group. This subject has been excluded from the analysis.|||units on a scale||Standard Error|Mean
1359385|NCT01685606|Secondary|To Evaluate the Rate of Dose Limiting Toxicities of HLA Haploidentical Peripheral Blood Pheresed Cellular Infusions.||30 days and 16 weeks after infusion||||participants|||Number
1359386|NCT01685606|Primary|Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.|"Criteria for AML and ALL (adapted from Cheson et al.20)~Complete remission (CR) is defined as the presence of all of the following~Peripheral blood~o No leukemic blasts present.~No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)~Bone marrow~Cellularity >20% with baseline maturation.~No Auer rods~Less than 5% blast cells.~Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC > 1.0 x 109/L and platelet count > 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free.~Complete remission with incomplete recovery (CRi) is defined as the following:~Meets criteria for CR except~ANC < 1.0 x 109/L or platelet count < 100x109/L~Partial remission (PR).~• Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts."|8 weeks after infusion then 6 months after and every 4 months for approximately 2 years||||participants|||Number
1359387|NCT01685567|Secondary|Ipsilateral Stroke (Non-hierarchical)|Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.|31-365 days||||Participants|||Count of Participants
1359388|NCT01685567|Secondary|All Stroke (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days||||Participants|||Count of Participants
1359603|NCT01683604|Secondary|Percentage of Participants by Reason for Choice of Monotherapy at Baseline||Baseline up to Month 6|Analysis was not performed as the data was not collected on case report form.||||||
1359391|NCT01685567|Primary|Hierarchical Composite of Stroke, Myocardial Infarction, and Death|The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.|30-day post-procedure||||Participants|||Count of Participants
1359392|NCT01685437|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.|||centimeters||Standard Deviation|Mean
1359393|NCT01685437|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.|||participants|||Number
1359394|NCT01685437|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1359395|NCT01685437|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1359396|NCT01685437|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.|||participants|||Number
1359397|NCT01685437|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
1359398|NCT01685437|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1359399|NCT01685437|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1359400|NCT01685437|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on modified intent-to-treat (mITT) population.|||percentage of curvature change||Standard Deviation|Mean
1359401|NCT01685372|Other Pre-specified|Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination|Seroprotection (HAI>=1:40) and seroconversion (4-fold increase) together have been found to be a better predictor of vaccine effectiveness. Patients had to have both a 4-fold rise in HAI and have HAI>=40 to be counted|(1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination|For T3, only 4 participants in the high-dose group and 5 participants in the standard-dose group were analyzed due to loss-to-follow-up.|||Participants|||Count of Participants
1359402|NCT01685372|Other Pre-specified|Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations|This secondary objective was included as exploratory and we plan to add additional analyses when funding is secured. There is no anticipated date when we will have this completed. (No immunogenicity studies have been done besides HAI.) For other immunogenicity: would compare results of blood draw #1 and #2 between the high-dose and standard-dose recipients for each patient group for any of the following: antibody avidity, microneutralization, T-cell interferon, T-cell IL-2, B-cell Immunoglobulin G (IgG) and B-cell Immunoglobulin A (IgA).|10-45 days post-vaccination|||||||
1359403|NCT01685372|Secondary|Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.|"Data gathered from the following~Safety data in 1st 14 days (safety surveys and safety diary)~Safety survey at day 30-45 regarding any unplanned health care visit or other AE during the 30 days after vaccine~On-going passive surveillance of adverse events (AEs)/serious adverse events (SAEs) throughout course of influenza season of enrollment~Chart review of each participant by PI through Sept 30 of the year following vaccine Data collection stopped in September following enrollment."|(1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine|Data used included: active reporting through day 30, survey at end of season, and chart review for data through Sept 30 of the year following vaccination.|||number of AEs reported|||Number
1359404|NCT01685372|Secondary|Change in Disease Status From Vaccination Through June of the Following Year|"Evaluate disease status changes reported by subject on Questionnaire #2 as well as changes reported in clinic notes over the course of the influenza season. Subjects considered worse had worsening function of transplanted organ or complications related to underlying condition (e.g. dialysis) or new diagnosis of disease considered serious by PI."|up to 9 months post-vaccination|One subject in the high-dose group was originally on dialysis, but received a kidney transplant during the follow-up period. This subject was excluded from the analysis on change in baseline medical condition.|||Participants|||Count of Participants
1359405|NCT01685372|Secondary|Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups|Measure HAI on blood sample #3, drawn May-September following vaccination. Report number who still have HAI ≥ 1:40 in the high-dose and standard-dose groups.|at least 5 months post vaccination|Number of subjects seroprotected at T3 for each of the vaccine subtypes. 3 subjects in the HD group and 4 subjects in the SD group were lost-to-follow-up by T3 and not included in this analysis.|||Participants|||Count of Participants
1359406|NCT01685372|Secondary|Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups|HAI was measured on blood samples #1 and #2 for all subjects. Seroconversion is defined as a four-fold increase in antibody level between the high-dose and standard-dose recipients within each patient group was performed.|10-45 days post-vaccination|All participants had blood drawn at baseline (T1) and 10-45 days after vaccination (T2). Analysis was done for the 3 influenza subtypes in the trivalent influenza vaccine. The influenza vaccine was the same in 2013-2014 and 2014-2015.|||Participants|||Count of Participants
1359407|NCT01685372|Secondary|Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination|Number of adverse events reported within the 14 days after vaccination by each subject within each patient group. Data collected from that reported in safety questionnaires and in Safety Diary that spanned the 14 days post-vaccination.|0-14 days after vaccination|All adverse events that may have been related are included in this analysis. Events considered not-related were excluded. More information on these AEs is included in the Adverse Events section. All AEs were reviewed by the study DSMB.|||number of AEs reported|||Number
1359408|NCT01685372|Primary|Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups|"Measure hemagglutinin inhibition (HAI) on blood samples #2 for all subjects, which is the sample drawn at the peak of the immune response. Compare number of subjects who are seroprotected (reaching HAI ≥ 1:40) between the high-dose and standard-dose recipients.."|blood draw at 10-45 days post-vaccination|All participants had blood drawn before vaccination and at timepoint 2. The influenza vaccine had the same subtypes during the two season. Data were analyzed for the 3 subtypes contained in the trivalent vaccine, H1N1, H3N2, B (Yamagata).|||Participants|||Count of Participants
1359409|NCT01685372|Primary|Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups|"Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following:~Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC)~Diagnosis of influenza by non-PCR rapid-influenza test~Diagnosis of ILI (from questionnaire #2). [Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.]"|up to 10 months after vaccination|Row 1: Number of influenza episodes diagnosed by PCR Row 2: Number of influenza episodes diagnosed by non-PCR rapid test Row 3: Number of influenza-like-illness (ILI) episodes reported by participants from the time of vaccination through June of the following year (end of flu season).|||episodes of illness|||Number
1359410|NCT01685320|Secondary|Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation|Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.|On average 20 seconds|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.|||seconds||Standard Deviation|Mean
1359411|NCT01685320|Primary|Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.|The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.|Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.|||Newton||Standard Deviation|Mean
1359412|NCT01685242|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359413|NCT01685242|Secondary|Nasal Composite Score at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||%participants with at least 1 nasal symp|||Number
1359414|NCT01685242|Secondary|Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||%participants with at least 1 nasal symp|||Number
1359415|NCT01685242|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359604|NCT01683604|Secondary|Time to Restoration of Initial Dosing Regimen||Baseline up to Month 6|Analysis was not performed due to inadequate data available for this outcome measure.||||||
1359416|NCT01685242|Secondary|Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359417|NCT01685242|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359418|NCT01685242|Secondary|Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359419|NCT01685242|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359420|NCT01685242|Secondary|Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359421|NCT01685242|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359422|NCT01685242|Secondary|Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359423|NCT01685242|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359424|NCT01685242|Secondary|Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359425|NCT01685242|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359426|NCT01685242|Secondary|Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359427|NCT01685242|Secondary|Chemosis at Onset of Action (15 Minutes)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359428|NCT01685242|Secondary|Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359429|NCT01685242|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359430|NCT01685242|Secondary|Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359431|NCT01685242|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359432|NCT01685242|Secondary|Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359433|NCT01685242|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359434|NCT01685242|Primary|Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359435|NCT01685242|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359436|NCT01685242|Primary|Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1359437|NCT01685216|Secondary|Number of Participants Who Developed Anti-Velaglucerase Alfa Antibodies During The Study|Participants provided blood samples for measurement of anti-velaglucerase alfa antibodies in serum at baseline and approximately every 12 weeks during the treatment phase. Blood samples collected during the treatment phase were to be drawn prior to infusions. Analysis of anti-velaglucerase antibodies used a validated 3-tier immunoassay method (screening, confirmatory, and titer).|Baseline, Weeks 13, 25, 37 and 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||participants|||Number
1359438|NCT01685216|Secondary|Number of Participants Who Experienced a Treatment-Emergent Adverse Event|Adverse events (AEs) were monitored continuously throughout the study from the time the participant or participants parent/legal guardian signed the informed consent/assent (if applicable) until 30 days after the participant’s last dose of study drug or at the end of study visit and/or until the event resolved or stabilized, or an outcome had been reached, whichever came first. Treatment-emergent adverse events (TEAEs) were defined as AEs which occurred on or after the time of the first infusion until 30 days after the participant’s last study infusion. An infusion-related reaction is defined as an AE that 1) began either during or within 12 hours after the start of the infusion, and 2) was judged as possibly or probably related to study medication.|57 weeks|The Safety Analysis population, defined as all participants who received at least 1 study drug infusion (full or partial).|||participants|||Number
1359439|NCT01685216|Secondary|Number of Participants With Abnormal Neurological Status During The Study|Neurological symptoms were evaluated at regular intervals during the study and assessed on an individualized basis by a limited, age- and developmental stage-appropriate neurological examination adapted to suit the status of each participant. It was preferred that each neurological examination be performed by a neurologist with experience in assessment of neurological symptoms in patients with Gaucher disease and, if possible, the same neurologist (or designee) who evaluated a given participant at baseline performed the neurological examinations scheduled for that participant during the treatment phase and at the end of study visit.|Baseline, Weeks 13, 25, 37, and 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||participants|||Number
1359440|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Spleen Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure spleen volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, spleen volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The spleen size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in spleen volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that spleen volume decreased.|Baseline, Week 51|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||percent change||Standard Deviation|Mean
1359441|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Liver Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure liver volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, liver volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The liver size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in liver volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that liver volume decreased.|Baseline, Week 51 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||percent change||Standard Deviation|Mean
1359442|NCT01685216|Secondary|Change From Baseline to 12 Months (Week 53) in Platelet Count|Platelet count was measured at a central laboratory as part of the hematology panel. Baseline is the modified baseline platelet count, the average of the values from screening, baseline and Week 1/Day 1. A positive change from baseline indicates that platelet count increased.|Baseline, Week 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||platelets (x10^9)/L||Standard Deviation|Mean
1359443|NCT01685216|Primary|Change From Baseline to 12 Months (Week 53) in Hemoglobin Concentration|Hemoglobin concentration was measured as part of the hematology panel or measured separately when the hematology panel was not scheduled. Samples were measured by a central laboratory. Baseline is the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1/Day 1. A positive change from baseline indicates that hemoglobin concentration increased.|Baseline, Week 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||g/dL||Standard Deviation|Mean
1359444|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events|Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.|From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1359445|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA < LLOQ at the final treatment visit.|||Percentage of participants||95% Confidence Interval|Number
1359446|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1359447|NCT01685203|Primary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1359448|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1359449|NCT01685060|Secondary|Overall Survival (OS)|OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.|||Months||95% Confidence Interval|Median
1359450|NCT01685060|Secondary|Overall Intracranial Response Rate (OIRR) Per BIRC|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by BIRC were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
1359451|NCT01685060|Secondary|Overall Intracranial Response Rate (OIRR) Per Investigator|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by Investigator were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
1359452|NCT01685060|Secondary|Progression-free Survival (PFS) Per BIRC|PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.|||months||95% Confidence Interval|Median
1359453|NCT01685060|Secondary|Progression-free Survival (PFS) Per Investigator|PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.|||months||95% Confidence Interval|Median
1359454|NCT01685060|Secondary|Time to Response (TTR) Per BIRC|TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.|||Months||Standard Deviation|Mean
1359455|NCT01685060|Secondary|Time to Response (TTR) Per Investigator|TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.|||Months||Standard Deviation|Mean
1359456|NCT01685060|Secondary|Disease Control Rate (DCR)|DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
1359605|NCT01683604|Secondary|Percentage of Participants With Reasons Who Discontinued Tocilizumab||Baseline up to Month 6|FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.|||percentage of participants|||Number
1359457|NCT01685060|Secondary|Duration of Response (DOR) by BIRC|DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per BIRC were included in this analysis.|||Months||95% Confidence Interval|Median
1359458|NCT01685060|Secondary|Duration of Response (DOR) by Investigator|DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per Investigator were included in this analysis.|||Months||95% Confidence Interval|Median
1359459|NCT01685060|Secondary|ORR Per Blinded Independent Review Committee (BIRC) Assessment|ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
1359460|NCT01685060|Primary|Overall Response Rate (ORR) to LDK378 Per Investigator Assessment|ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
1359461|NCT01685021|Secondary|Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam|Number of patients with treatment-emergent AEs|weekly, up to 7 months||||number of patients with 1 or more AE|||Number
1359462|NCT01685021|Secondary|Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity||monthly, up to 7 months|Anti-MOR208 antibodies were not observed in any patients treated during this study.|||patients|||Number
1359463|NCT01685021|Secondary|Pharmacokinetics of MOR00208|Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infusion)|weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)||||mcg/mL||Standard Deviation|Mean
1359464|NCT01685021|Secondary|Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam|Number of patients with at least one treatment-emergent AE|weekly, up to 7 months||||patients|||Number
1359465|NCT01685021|Secondary|Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT|Two patients had a response to treatment. For one of the two patients a progression was recorded, the other patient was censored due to an AE. Conse quently, the planned Kaplan-Meier analyses of response duration and time to hematological relapse could not be calculated.|Throughout during study until progression, after each treatment cycle||||days|||Number
1359466|NCT01685021|Primary|Overall Response Rate (ORR)|"ORR= CR (Complete Remission) + PR (Partial Remission)~Antitumor activity of MOR00208"|Throughout during study until progression, after each treatment cycle||||participants|||Number
1359467|NCT01684930|Secondary|Change in Angiogenesis|Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups|Baseline and 16 weeks|Participants who had a gastrocnemius muscle biopsy with enough tissue to analyze.|||capillaries per fibrer||Standard Deviation|Mean
1359468|NCT01684930|Secondary|Change In Vascular Function (BAFMD)|Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD). BAFMD is a measure of change in artery diameter after a stimulus .|Baseline and 16 weeks|participants with analyzable data|||% dilation||Standard Deviation|Mean
1359469|NCT01684930|Secondary|Change In Claudication Onset Time|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.|Baseline and 16 weeks||||seconds||Standard Deviation|Mean
1359470|NCT01684930|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks||||feet||Standard Deviation|Mean
1359471|NCT01684930|Primary|Change In Time To Exhaustion|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.|Baseline and 16 weeks||||seconds||Standard Deviation|Mean
1359472|NCT01684930|Primary|Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.|Baseline and 16 Weeks|All participants who completed study.|||ml/kg/min||Standard Deviation|Mean
1359473|NCT01684878|Secondary|Part 2: Overall Survival|Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis)|||months||95% Confidence Interval|Median
1359474|NCT01684878|Secondary|Part 2: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|Safety population included all participants who had received at least 1 dose of pertuzumab, pertuzumab-placebo, or chemotherapy.|||percentage of participants|||Number
1359475|NCT01684878|Secondary|Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life.|Baseline (assessed at baseline and every 9 weeks from randomization until disease progression)|ITT population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).|||units on a scale||Standard Deviation|Mean
1359476|NCT01684878|Secondary|Part 2: Progression-free Survival (PFS) Assessed by the Investigator|PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis)|||months||95% Confidence Interval|Median
1359477|NCT01684878|Secondary|Part 1: PFS Assessed by the Investigator|PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day.|Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.|||months||95% Confidence Interval|Median
1359478|NCT01684878|Secondary|Part 2- Objective Response Rate (ORR)|ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT population with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
1359479|NCT01684878|Secondary|Part 1- Objective Response Rate (ORR)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression)|All Treated participants with measurable disease at baseline.|||percentage of participants|||Number
1359480|NCT01684878|Primary|Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)|PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population was defined as all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).|||months||95% Confidence Interval|Median
1359481|NCT01684878|Primary|Part 1: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.|||percentage of participants|||Number
1359482|NCT01684839|Other Pre-specified|Tinel’s Sign|Tinel’s sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma|20-26 months postoperatively|||||||
1359483|NCT01684839|Secondary|Cold Intolerance Severity Score (CISS) Questionnaire|The maximum score was 100 and was grouped into 4 ranges (0–25; 26–50; 51–75; and 76–100), corresponding to mild, moderate, severe, and extreme severity, respectively.|20-26 months postoperatively|||||||
1359484|NCT01684839|Primary|Static 2-point Discrimination Test|The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6–10 mm; fair 11–15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.|20-26 months postoperatively||||mm||Standard Deviation|Mean
1359485|NCT01684826|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)|||percentage of dose change||Standard Deviation|Mean
1359486|NCT01684826|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)|||percentage of dose change||Standard Deviation|Mean
1359487|NCT01684826|Primary|Image Quality|"Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.~The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used."|1 day|All patient with recorded dose information and images for both angiograms were used.|||proportion of readers||90% Confidence Interval|Mean
1359488|NCT01684748|Other Pre-specified|Collagen Gene Expression in Skeletal Muscle (Change Over Time)|RNA extraction and quantification were determined using an RNeasy Mini Fibrous Kit and DNase I treatment (Qiagen, Valencia, CA, USA) in accordance to the manufacturer’s directions for mRNA extraction. Quantitative real-time polymerase chain reaction (qRT-PCR) measured the expression of collagen III using an ABI PRISM 7900 Sequence Detection System instrument and TaqMan Universal PCR Master Mix according to the manufacturer’s instructions (Applied Biosystems, Foster City, CA, USA). Relative gene expression levels were determined using the number of cycles necessary to reach threshold and results were normalized to cyclophilin B RNA levels.|Baseline testing to post-testing after 8-week intervention|Results are reported for the Olmesartan Medoxomil intervention only; there was insufficient RNA yield for the majority of participants during the no drug treatment. Only 7 of the 16 study participants who participated in the study measurements had sufficient data to analyze the pre- and post-intervention skeletal muscle biopsy tissues.|||Arbitrary unit (AU)||Standard Error|Mean
1359489|NCT01684748|Primary|Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)|Data collected from the intravenous glucose tolerance tests included blood concentrations of glucose and insulin. Glucose was measured immediately on a YSI glucose analyzer and insulin was measured via ELISA colormetric kits once all study samples were collected. To analyze changes in insulin sensitivity, the MINMOD software was used. The MINMOD software uses Bergman's minimal model to determine insulin sensitivity during an intravenous glucose tolerance test. Both glucose and insulin values were inserted at each timepoint collected (33 in total over the 3-hour protocol) and the software was run to generate the insulin sensitivity value at baseline and post-test. This information was then used to calculate the change of insulin sensitivity from baseline to post-testing after each 8-week intervention.|Baseline testing to post-testing after 8-week intervention|Results of insulin sensitivity by intravenous glucose tolerance (IVGTT) testing are reported per intervention (Olmesartan Medoxomil and No drug). Only 10 of the 16 study participants who participated in all or some of the study measurements opted to complete or had sufficient data to analyze for each pre- and post-intervention (4 total) IVGTT.|||mu/L/min||Standard Deviation|Mean
1359490|NCT01684592|Secondary|NicCheck Test Results for Cotinine Level From Infant Urine|Infant urine was collected at 6 months postpartum using the “cotton roll” method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant’s urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between “low” (score 1-6) versus “high” (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.|6 months postpartum||||units on a scale||Standard Deviation|Mean
1359491|NCT01684592|Secondary|Times Mother Smoked in the Room With Infant|Based on the number of days of smoking in the same room with infant in the past 90.|Baby's birth to 6 months postpartum|Only current smokers responded to this question|||number of days smoked||Standard Deviation|Mean
1359492|NCT01684592|Secondary|Times Mother Smoked While Breastfeeding|Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.|Baby's birth to 6 months postpartum|Only 7 women reported having breastfed at 6 month postpartum|||times smoked in past 90 days||Standard Deviation|Mean
1359493|NCT01684592|Secondary|Past 90-day Tobacco Use|Self-reported number of days smoked tobacco in past 90 days.|6 months postpartum||||days||95% Confidence Interval|Mean
1359494|NCT01684592|Secondary|Past 90-day Tobacco Use|Self-reported number of days smoked in past 90 days|3 months postpartum||||days||95% Confidence Interval|Mean
1359495|NCT01684592|Secondary|Number of Tobacco Products Per Day|Self-reported number of tobacco products smoked per day|3 months postpartum||||tobacco products||95% Confidence Interval|Mean
1359496|NCT01684592|Primary|Number of Tobacco Products Per Day|Self-reported number of tobacco products smoked per day|6 months postpartum||||tobacco products||95% Confidence Interval|Mean
1359497|NCT01684566|Secondary|Duration of Oral Mucositis, Per Protocol Population|Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis is graded according to the 5-point oral mucositis WHO scale Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible|28 days|Per Protocol (PP). There were 9 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis|||Days||Standard Deviation|Mean
1359498|NCT01684566|Secondary|Occurence of Oral Mucositis, Per Protocol Population|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organisation) oral toxicity scale grade 0-4~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP)|||participants|||Number
1359499|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores AUC Over the 28-Day Period Per protocol population.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP) without Last observation carried over(LOCF)|||score||Standard Deviation|Mean
1359500|NCT01684566|Secondary|Hospital Stay, Days|Duration of hospital stay (time from admission to discharge)|28 days|Intention to treat (ITT) Hospital stay, days|||Days||Standard Deviation|Mean
1359501|NCT01684566|Secondary|Oral Mucositis Assessment Scale (OMAS)|"Summary of Oral Mucositis Assessment Scale (OMAS) Ulceration and Erythema Scores Extent of ulceration (grade 0-3) and severity of erythema (grade 0-2) according to the OMAS (Oral Mucositis Assessment Scale) assessed by a dental practitioner twice-weekly over the 28-day study period.~The extent of ulceration was rated as follows:~0 no lesion~1 cm2~1-3 cm2~>3 cm2~The severity of erythema was assessed as follows:~0 none~not severe~severe"|28 days|Intention to treat (ITT) Ulceration and Erythema.OMAS was only performed in sites were a dentist was available therefore lower numbers in the analysis.|||score||Standard Deviation|Mean
1359502|NCT01684566|Secondary|Oral Mucositis Daily Questionnaire (OMDQ)|OMDQ (Oral Mucositis Daily Questionnaire) scale was used to measure Overall Mouth and Throat Soreness This was scored from 0=no soreness to 10=worst possible soreness.|28 days|Intention to treat(ITT) OMDQ AUC over time. Not all patients reported data from OMDQ therefore there is lower number of patients in this analysis.|||units on a scale||Standard Deviation|Mean
1359503|NCT01684566|Secondary|Duration of Oral Mucositis, Intention to Treat Population|"Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis was graded according to WHO 5 Point grading scale on a daily basis.~Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|ITT (Intention to treat). There were13 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis|||Days||Standard Deviation|Mean
1359504|NCT01684566|Secondary|Occurrence of Oral Mucositis|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organization) oral toxicity scale grade 0-4.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT)|||participants|||Number
1359505|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores Area under the curve (AUC) over the 28-Day Period ITT Populations.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT) and Last observation carried forward (LOCF)|||score||Standard Deviation|Mean
1359506|NCT01684436|Primary|Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 3|All patients who completed the study|||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
1359507|NCT01684436|Secondary|Dry Eye Questionnaire Irritation Score|Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms.|Week 0 (Baseline), Week 3|All patients who completed the study|||Millimeters (mm)||Standard Deviation|Mean
1359508|NCT01684436|Secondary|Schirmer's Test Score|The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Week 0 (Baseline), Week 3|All patients who completed the study|||Millimeters (mm)||Standard Deviation|Mean
1359509|NCT01684436|Secondary|Tear Film Break-up Time (TBUT)|TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.|Week 0 (Baseline), Week 3|All patients who completed the study|||Seconds||Standard Deviation|Mean
1359606|NCT01683604|Secondary|Mean Dosing Interval at Month 6|The time interval between two successive doses in days was reported.|Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||days||Standard Deviation|Mean
1359510|NCT01684436|Secondary|Corneal Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.|Week 0 (Baseline), Week 3|All patients who completed the study|||Scores on a Scale||Standard Deviation|Mean
1359511|NCT01684436|Primary|Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 0 (Baseline)|All patients who completed the study|||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
1359512|NCT01684423|Secondary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points|Geometric and percentage geometric coefficient of variation (%CV) were reported.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
1359513|NCT01684423|Secondary|Anti-factor Xa Values at Specified Time Points|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.|||microgram per liter (mcg/L)||Standard Deviation|Mean
1359514|NCT01684423|Secondary|Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.|||seconds||Standard Deviation|Mean
1359515|NCT01684423|Secondary|Change From Baseline in Prothrombin Time at Specified Time Points|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.|||seconds||Standard Deviation|Mean
1359516|NCT01684423|Secondary|Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden|The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.|Repeat imaging at the end of the 30 day treatment period|Full analysis set|||Participants|||Number
1359517|NCT01684423|Secondary|Number of Subjects With Symptomatic Recurrent Venous Thromboembolism|The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.|From start of study drug administration until end of the 30-day treatment period|Full analysis set|||Participants|||Number
1359518|NCT01684423|Primary|Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events|"Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:~associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or~leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or~occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or~contributing to death.~Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:~medical intervention, or~unscheduled contact (visit or telephone call) with a physician, or~cessation (temporary) of study treatment, or~discomfort for the child such as pain or~impairment of activities of daily life (such as loss of school days or hospitalization)."|From start of study drug administration until end of the 30-day treatment period|Full analysis set. Data was evaluated only for subjects who received active study medication.|||Participants|||Number
1359519|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 3|FVC conducted before and after inhalation of the investigational product|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)|||percent||Standard Deviation|Mean
1359520|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|FEV1 conducted before and after inhalation of the investigational product at study visits.|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)|||percent||Standard Deviation|Mean
1359521|NCT01684410|Primary|Adverse Events|adverse event frequency|3 weeks|Safety Population: included all subjects who received any dose of IP (included those withdrawn from treatment for any reason)|||percentage of participants|||Number
1359522|NCT01684215|Secondary|Presence of Tumor Tissue Biomarkers- Estrogen Receptor (ER) H-Score, Retinoblastoma (Rb) H-Score, B-cell Lymphoma-1 (BCL-1) H-Score, P16 H-Score: Phase 2|Tumor tissue biomarkers ER, Rb, BCL-1 and P16 were analyzed to investigate possible associations with resistance or sensitivity to treatment with study drugs and were selected based on their known relevance to mechanisms involved in cell cycle regulation. Number of participants with positive ER (H-Score), Rb (H-Score), BCL-1 (H-Score) and P16 (H-Score) tumor tissue biomarkers were reported. The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors.|Baseline (Day 1)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
1379752|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|12 week follow up|||||||
1359523|NCT01684215|Secondary|Presence of Tumor Tissue Biomarker- Ki67: Phase 2|Tumor tissue biomarker, Ki67 was analyzed to investigate possible associations with resistance or sensitivity to treatment with study drugs and was selected based on its known relevance to mechanisms involved in cell cycle regulation. Number of participants with less than or equal to and greater than 20 percent of Ki67 tumor tissue biomarker were reported.|Baseline (Day 1)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
1359524|NCT01684215|Secondary|Change From Baseline in Trial Outcome Index (TOI): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and End of Treatment|FACT is a modular approach to assess participant’s health-related quality of life. TOI total score was derived from the sum of these 3 sub-scale scores: physical well-being, functional well-being (both sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life) and breast cancer subscale (consists of 9 items and ranging from 0 to 36, where higher scores indicating better quality of life). Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-B total score range was of 0 (not at all good) to 92 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, End of treatment (Day 677)|"PRO analysis set was a subset of the full analysis set and included participants with both baseline and at least 1 complete post-baseline PRO assessment. Here, n signifies number of participants evaluable for specified time points."|||units on a scale||95% Confidence Interval|Mean
1359525|NCT01684215|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and End of Treatment|FACT is a modular approach to assess participant’s health-related quality of life. FACT-G total score was derived from the sum of these 4 sub-scale scores: physical well-being, social/family well-being and functional well-being (all 3 sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life), emotional well-being (consists of 6 items and ranging from 0 to 24, where higher scores indicating better quality of life. Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-G total score range was of 0 (not at all good) to 108 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, End of treatment (Day 677)|"PRO analysis set was a subset of the full analysis set and included participants with both baseline and at least 1 complete post-baseline PRO assessment. Here, n signifies number of participants evaluable for specified time points."|||units on a scale||95% Confidence Interval|Mean
1359526|NCT01684215|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and End of Treatment|The functional assessment of cancer therapy (FACT) is a modular approach to assess participant’s health-related quality of life. FACT-B total score was derived from the sum of these 5 sub-scale scores: physical well-being, social/family well-being and functional well-being (all 3 sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life), emotional well-being (consists of 6 items and ranging from 0 to 24, where higher scores indicating better quality of life, and a breast cancer subscale (consists of 9 items and ranging from 0 to 36, where higher scores indicating better quality of life). Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-B total score range was of 0 (not at all good) to 144 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, End of treatment (Day 677)|"Patient reported outcome (PRO) analysis set was a subset of the full analysis set and included participants with both baseline and at least 1 complete post-baseline PRO assessment. Here, n signifies number of participants evaluable for specified time points."|||units on a scale||95% Confidence Interval|Mean
1359527|NCT01684215|Secondary|Overall Survival (OS): Phase 2|Overall survival was defined as the time from first dose of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. OS was estimated with Kaplan-Meier method.|From initiation of treatment up to follow-up period (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||months||95% Confidence Interval|Median
1359528|NCT01684215|Secondary|Percentage of Participants With Disease Control (DC): Phase 2|Disease control was defined as CR, PR or stable disease for >=24 weeks according to the RECIST version 1.1 recorded in the time period between first dose of study treatment and disease progression or death to any cause. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]). PR was defined as >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Stable disease was defined as not achieving an objective response with confirmed CR or PR according to RECIST version 1.1, as determined by the investigators, relative to the response evaluable population, but remained stable for at least 24 weeks after first dose, then the best overall response for such a participant was considered as stable disease. Percentage of participants with disease control were reported.|From initiation of treatment up to disease progression (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants|||Number
1359529|NCT01684215|Secondary|Progression Free Survival (PFS): Part 2 Phase 1|PFS was defined as the time from first dose of study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From initiation of treatment up to disease progression (up to 30 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Data for this outcome measure was not summarized and individual participant's data was reported.|||months|||Number
1359607|NCT01683604|Secondary|Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change|Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.|Baseline up to Month 6|FAS population.|||percentage of participants|||Number
1359530|NCT01684215|Secondary|Duration of Response (DOR): Phase 2|Duration of response was defined as the interval from the first documentation of objective tumor response in participants with CR (disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]) or PR (a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to RECIST version 1.1 to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first.|From initiation of treatment up to disease progression (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Here, number of participants analyzed (N) signifies the participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1359531|NCT01684215|Secondary|Duration of Response (DOR): Part 2 Phase 1|Duration of response was defined as the interval from the first documentation of objective tumor response in participants with CR (disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]) or PR (a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to RECIST version 1.1 to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first.|From initiation of treatment up to disease progression (up to 30 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Data for this outcome measure was not summarized and individual participant's data was reported. Here, number of participants analyzed (N) signifies the participants evaluable for this outcome measure.|||months|||Number
1359532|NCT01684215|Secondary|Percentage of Participants With Objective Response: Phase 2|Objective response was defined as a complete response (CR) or partial response (PR) according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression or death due to any cause. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]). PR was defined as a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Percentage of participants with objective response (who achieved CR or PR) were reported.|From initiation of treatment up to disease progression (up to 21 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants|||Number
1359533|NCT01684215|Secondary|Percentage of Participants With Objective Response: Phase 1|Objective response was defined as a complete response (CR) or partial response (PR) according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression or death due to any cause. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]). PR was defined as a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Percentage of participants with objective response (who achieved CR or PR) were reported.|From initiation of treatment up to disease progression (up to 30 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants|||Number
1359534|NCT01684215|Secondary|Pre-dose Plasma Concentration (Ctrough) of PD-0332991: Phase 2|Ctrough is pre-dose concentration during multiple dosing which is observed directly from the actual time-concentration data.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1359535|NCT01684215|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991: Phase 2|Tmax is time at which maximum plasma concentration (Cmax) was observed. It was observed directly from data as time of first occurrence.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||hour||Full Range|Median
1359536|NCT01684215|Secondary|Maximum Observed Plasma Concentration (Cmax) Of PD-0332991: Phase 2|Cmax is maximum plasma concentration which is observed directly from the actual time-concentration data.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1359537|NCT01684215|Secondary|Apparent Oral Clearance of PD-0332991: Phase 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1359538|NCT01684215|Secondary|Area Under the Plasma Concentration Time Curve Over Dosing Interval (AUCtau) of PD-0332991: Phase 2|AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359539|NCT01684215|Secondary|Volume of Distribution (Vz/F) of PD-0332991 Following Single Dose: Part 1 Phase 1|Vz/F is apparent volume of distribution estimated from terminal phase, which is calculated as CL/F/kel. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method (AUCinf). kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||liter||Geometric Coefficient of Variation|Geometric Mean
1359540|NCT01684215|Secondary|Terminal Half-Life (t1/2) of PD-0332991: Part 1 Phase 1|t1/2 is terminal elimination half-life which is calculated by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||hour||Standard Deviation|Mean
1359541|NCT01684215|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991: Part 1 Phase 1|Tmax is time at which maximum plasma concentration (Cmax) was observed. It was observed directly from data as time of first occurrence.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||hour||Full Range|Median
1359542|NCT01684215|Secondary|Linearity (Rss) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Rss is the ratio of AUCtau (after multiple doses) to AUCinf (after single dose). AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method. AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ratio||Full Range|Median
1359543|NCT01684215|Secondary|Accumulation Ratio (Rac) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Rac is the ratio of AUCtau (after multiple doses) to AUCtau (after single dose). AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ratio||Full Range|Median
1359544|NCT01684215|Secondary|Pre-dose Plasma Concentration (Ctrough) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Ctrough is pre-dose concentration during multiple dosing which is observed directly from the actual time-concentration data.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1359545|NCT01684215|Secondary|Cmax Dose Normalized to 125 mg of PD-0332991: Part 1 Phase 1|Cmax Dose Normalized to 125 mg is maximum plasma concentration dose normalized to 125 mg which is observed directly from the actual time-concentration data.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1359546|NCT01684215|Secondary|Maximum Observed Plasma Concentration (Cmax) Of PD-0332991: Part 1 Phase 1|Cmax is maximum plasma concentration which is observed directly from the actual time-concentration data.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1359547|NCT01684215|Secondary|Apparent Oral Clearance of PD-0332991: Part 1 Phase 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by AUCinf. AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1359548|NCT01684215|Secondary|AUClast Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUClast Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to time of last measurable concentration dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359549|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Time of Last Measurable Concentration (AUClast) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUClast is area under the plasma concentration-time curve from 0 to time of last measurable concentration which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359550|NCT01684215|Secondary|AUCinf Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUCinf Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to infinity dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359551|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Infinity (AUCinf) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359552|NCT01684215|Secondary|AUC24 Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUC24 Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to time 24 hours dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12 and 24 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359553|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Time 24 Hours (AUC24) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUC24 is area under the plasma concentration-time curve from 0 to time 24 hours which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12 and 24 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359554|NCT01684215|Secondary|AUCtau Dose Normalized to 125 Milligram (mg) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|AUCtau Dose Normalized to 125 mg is area under the plasma concentration-time curve over dosing interval dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1359555|NCT01684215|Secondary|Area Under the Plasma Concentration Time Curve Over Dosing Interval (AUCtau) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|Pharmacokinetic (PK) parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1359556|NCT01684215|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Abnormality criteria: hemoglobin: <0.8*lower limit of normal [LLN], platelets: <0.5*LLN or >1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil,monocytes: >1.2*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase (GT): >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN, total bilirubin, direct bilirubin: >1.5*ULN; blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium: <0.9*LLN or >1.1*ULN, phosphate: <0.8*LLN or >1.2*ULN; creatine kinase: >2.0*ULN, glucose fasting: <0.6*LLN or >1.5*ULN, glycosylated haemoglobin: >1.3*ULN;urinalysis dipstick (urine protein, urine blood >=1); urine protein 24 hour: >1.1*ULN; coagulation Activated partial thromboplastin time [APTT], Prothrombin, prothrombin international ratio: >1.1*ULN.|Lead- in period (Day -7) up to end of treatment (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
1359557|NCT01684215|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) By Severity: Phase 1 (Part 1) and Phase 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment but increased in NCI CTCAE grade during study treatment period. AE severity was defined to be the maximum toxicity grade of the TEAEs experienced by the participants during the study. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|Part 1 Phase 1: Lead-in period (Day -7) up to 28 days after last dose of study drug (Day 308), Phase 2: Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
1359558|NCT01684215|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Phase 1 (Part 1) and Phase 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious adverse events.|Part 1 Phase 1: Lead-in period (Day -7) up to 28 days after last dose of study drug (Day 308), Phase 2: Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
1359559|NCT01684215|Primary|Percentage of Participants With 1 Year Progression Free Survival (PFS): Phase 2|PFS was defined as the time from first dose of study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.1-year PFS was defined as the percentage of participants without PFS events (PD or death due to any cause) at 12 months based on the Kaplan-Meier estimate. Percentage of participants with 1-year PFS with 90% confidence interval (CI) were reported.|From initiation of treatment up to follow-up period (up to 12 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants||90% Confidence Interval|Number
1359608|NCT01683604|Secondary|Median Dose at Month 6||Month 6|FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.|||milligram per kilogram (mg/kg)||Full Range|Median
1359560|NCT01684215|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity: Part 2 Phase 1|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment but increased in National Cancer Institute (NCI) CTCAE grade during study treatment period. AE severity was defined to be the maximum toxicity grade of the TEAEs experienced by the participants during the study. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
1359561|NCT01684215|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2 Phase 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 28 days after last dose of study drug (Day 677)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
1359562|NCT01684215|Primary|Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1|DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.|Lead-in period (Day -7) up to Day 28 (Cycle 1)|DLT analysis set included all participants whom DLTs were evaluable in Part 1 Phase 1.|||participants|||Number
1359563|NCT01684046|Primary|Subjective Lens Wear Comfort|"Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, When I use this solution, I can comfortably wear my lenses, with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree."|Day 30|This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.|||units on a scale||Standard Deviation|Mean
1359564|NCT01684033|Primary|Change From Baseline in Corneal Staining at Day 30|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Baseline (Day 0), Day 30||||units on a scale||Standard Deviation|Mean
1359565|NCT01684033|Primary|Corneal Staining|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Day 30|This analysis population group includes all participants who were exposed to both treatment regimens.|||Units on a scale||Standard Deviation|Mean
1359566|NCT01684007|Secondary|Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)|VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.|||logMAR||Standard Deviation|Mean
1359567|NCT01684007|Primary|Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)|Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.|||logMAR||Standard Deviation|Mean
1359568|NCT01683864|Other Pre-specified|Kinetics of Mitomycin and Cisplatin||24 hours after application|||||||
1359569|NCT01683864|Other Pre-specified|Procedure Related Complication|No study results because no patient has received study drug.|60 days|||||||
1359570|NCT01683864|Primary|Disease Free Survival|No study results because no patient has received study drug.|5 years|||||||
1359571|NCT01683864|Primary|Peritoneal Carcinosis Free Survival|Three patients were enrolled in the study. No study results because no patient has received study drug.|5 Years|No study results because no patient has received study drug. Patient in the intervention group withdrawal of consent before intervention.||||||
1359572|NCT01683838|Secondary|Adjusted Mean Change in Subject Bowel Function Diary Scores|"Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.~A negative change in patient bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||minutes||Standard Error|Mean
1359573|NCT01683838|Secondary|Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores|"Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.~A negative change in patient bladder/bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||episodes||Standard Error|Mean
1359574|NCT01683838|Secondary|Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores|"The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).~A positive change signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98||||units on a scale||Standard Error|Mean
1359575|NCT01683838|Secondary|Change From Baseline in Mean International Index of Erectile Function (IIEF) Score|"Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.~Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98|ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.|||units on a scale||Standard Error|Mean
1359576|NCT01683838|Secondary|Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score|Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.|Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.|||units on a scale||Standard Error|Mean
1359577|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores|The supervising clinician rated the patient’s neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician’s overall impression of the patient’s neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.|Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
1359578|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores|"The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.~The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.~On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
1359579|NCT01683838|Primary|Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores|"The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.~The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
1359580|NCT01683838|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|"The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:~1=no increased tone; 2=slight increase in tone, giving a catch when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.~The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
1359581|NCT01683812|Secondary|Cranial Measurement Description|To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.|Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)||||cranial index %||Full Range|Median
1359582|NCT01683812|Primary|Feasibility and Safety|Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of < 90 percent for infant corrected to full term or < 87 percent for a premature infant for > 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.|Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days||||count||Full Range|Median
1359583|NCT01683630|Primary|Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba||Upto 15 years||||percentage of participants|||Number
1359584|NCT01683630|Primary|Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba||upto 15 years||||Percentage of participants|||Number
1359585|NCT01683630|Primary|Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba||up to 15 years||||Percentage of participants||95% Confidence Interval|Number
1359586|NCT01683604|Secondary|Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
1359587|NCT01683604|Secondary|Change From Baseline in Patient's Assessment of Pain at Months 3 and 6|Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.|||mm||Standard Deviation|Mean
1359588|NCT01683604|Secondary|Change From Baseline in VAS-Fatigue at Months 3 and 6|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
1359589|NCT01683604|Secondary|Change From Baseline in HAQ-DI Score at Months 3 and 6|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ­D1 score reported at baseline and the HAQ­D1 score reported at Month 3 and Month 6.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.|||units on a scale||Standard Deviation|Mean
1359590|NCT01683604|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
1359591|NCT01683604|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
1359592|NCT01683604|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment|ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.|||percentage of participants||95% Confidence Interval|Number
1359593|NCT01683604|Secondary|Simplified Disease Activity Index (SDAI) Score by Visit|The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.|||units on a scale||Standard Deviation|Mean
1359594|NCT01683604|Secondary|Change From Baseline in TJC and SJC at Month 3 and Month 6|TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||joint counts||Standard Deviation|Mean
1359595|NCT01683604|Secondary|Clinical Disease Activity Index (CDAI) Score by Visit|The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.|||units on a scale||Standard Deviation|Mean
1359596|NCT01683604|Secondary|Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c­reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.|||percentage of participants|||Number
1359597|NCT01683604|Secondary|Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit|The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.|||units on a scale||Standard Deviation|Mean
1359598|NCT01683604|Secondary|Percentage of Participants Adhering to Local Label for Adverse Events|Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.|Baseline up to Month 6|FAS population. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
1359599|NCT01683604|Secondary|Percentage of Participants With and Without Morning Stiffness|"Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:~Presence of participant's joints stiff when woke up that day, measured as yes or no~Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: < 30 minutes, between 30 and 240 minutes, > 240 minutes, and the whole day.~Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness."|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||percentage of participants|||Number
1359600|NCT01683604|Secondary|Percentage of Participants by Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (<) 30 minutes, between 30 and 240 minutes, greater than (>) 240 minutes and whole day.|Baseline, Month 3, Month 6|FAS population. Here, n= participants with available data at specified visit.|||percentage of participants|||Number
1359611|NCT01683604|Primary|Erythrocyte Sedimentation Rate (ESR) at Baseline|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||mm/hr||Standard Deviation|Mean
1359612|NCT01683604|Primary|Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.|||joint counts||Standard Deviation|Mean
1359613|NCT01683604|Primary|Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1359614|NCT01683604|Primary|Physician Global Assessment of Disease Activity Using VAS at Baseline|Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||mm||Standard Deviation|Mean
1359615|NCT01683604|Primary|Patient Global Assessment of Disease Activity Using VAS at Baseline|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||mm||Standard Deviation|Mean
1359616|NCT01683604|Primary|Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline|Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||millimeters (mm)||Standard Deviation|Mean
1359617|NCT01683604|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation|Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.|Month 6|FAS population|||percentage of participants|||Number
1359618|NCT01683526|Secondary|Complications of Intubation|Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.|For 10 minutes post intubation||||percentage of other complications|||Number
1359619|NCT01683526|Secondary|Cardiac Arrest||For 1 hour post intubation||||percentage of cardiac arrest|||Number
1359620|NCT01683526|Secondary|Hypotension|SBP<70|For 10 minutes post intubation||||percentage of hypotension|||Number
1359621|NCT01683526|Secondary|Severe Desaturation|sat <80%|For 10 minutes post intubation||||percentage of patients with desaturation|||Number
1359622|NCT01683526|Primary|First Pass Success Rate||From begining of intubation to verification. Less then 5 minutes approximatly||||percentage of first pass success|||Number
1359623|NCT01683409|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)|Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanomole*hour (nM*hr)||Standard Deviation|Mean
1359624|NCT01683409|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24|EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.|Baseline, Week 24|All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1359625|NCT01683409|Secondary|Change From Baseline in Creatinine Clearance at Week 24|Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.|Baseline, Week 24|All randomized participants who received at least one dose of study drug.|||milliliter/minute (mL/min)||Standard Error|Least Squares Mean
1359626|NCT01683409|Secondary|Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio||Baseline, Week 24|Zero participants analyzed. No data analyzed due to urinary MCP-1 and creatinine being measured on different urine samples from different time points and thus not able to correlate.||||||
1359627|NCT01683409|Primary|Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24|UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to <50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.|Baseline, Week 24|All randomized participants who received at least one dose of study drug.|||milligram/gram (mg/g)||Standard Error|Least Squares Mean
1359628|NCT01683383|Other Pre-specified|Safety Outcomes|The incidence, intervention and outcome of cardiac arrhythmia, major bleeding, altered skin integrity, pulmonary hypertension, device-related events, death, and other serious adverse events from the time of initiation of transport cooling to the time of completion will be monitored.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm|||Participants|||Number
1359629|NCT01683383|Secondary|Participants in Target Temperature Range Anytime During Transport|Participants in target temperature range (33-34 C) anytime during transport|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm|||Participants|||Number
1359630|NCT01683383|Secondary|Percentage of Participants in the Target Range at 1 Hour|Percentage of participants in target range (33°-34°C) one hour after cooling initiation by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm, excluding 8 participants in the control arm and 12 participants in the device arm who completed transport in < 1 hour.|||Percentage of participants|||Number
1359631|NCT01683383|Secondary|Time to Target Temperature|Time to the target temperature range (33°-34°C) from initiation of cooling by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm|||Minutes||Standard Deviation|Mean
1359632|NCT01683383|Primary|Percentage of Temperatures in Target Range During Transport|The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm|||Percentage of temperatures||Inter-Quartile Range|Median
1359633|NCT01683266|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
1359634|NCT01683266|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.|||units on a scale||Standard Error|Least Squares Mean
1359635|NCT01683266|Secondary|Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.|||U/kg||Standard Deviation|Mean
1359636|NCT01683266|Secondary|Change in 8-­Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time­point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8­point SMPG assessment separately for each analysed time point.|||mmol/L||Standard Deviation|Mean
1359637|NCT01683266|Secondary|Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.|||percentage of participants|||Number
1359638|NCT01683266|Secondary|Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6||Month 6|mITT Population.|||percentage of participants|||Number
1359639|NCT01683266|Secondary|Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.|||mmol/L||Standard Error|Least Squares Mean
1359640|NCT01683266|Secondary|Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint|Pre­injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.|||percentage of mean||Standard Error|Least Squares Mean
1379753|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|5 weeks (or after treatment session 10)|||||||
1359641|NCT01683266|Secondary|Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint|Pre­injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1359642|NCT01683266|Secondary|Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint||Month 6|mITT Population.|||percentage of participants|||Number
1359643|NCT01683266|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population.|||percentage of participants|||Number
1359644|NCT01683266|Primary|Change In HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post­baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1359645|NCT01683058|Secondary|Number of Participants With Clinically Relevant Physical Examination.|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant.|||participants|||Number
1359646|NCT01683058|Secondary|Number of Participants With Clinically Relevant Laboratory Values.|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study.|||participants|||Number
1359647|NCT01683058|Secondary|Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.|Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included.|||cm||Standard Deviation|Mean
1359648|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.|Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||Kg/m2||Standard Deviation|Mean
1359649|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.|Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||Kg||Standard Deviation|Mean
1359650|NCT01683058|Secondary|Mean Change in QTcN Interval From Baseline in All Participants.|The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
1359651|NCT01683058|Secondary|Mean Change in QTcF Interval From Baseline in All Participants.|The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
1359669|NCT01683058|Primary|Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death|A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Percentage of participants|||Number
1359652|NCT01683058|Secondary|Mean Change in QTcB Interval From Baseline in All Participants.|The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
1359653|NCT01683058|Secondary|Mean Change in QT Interval From Baseline in All Participants.|The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
1359654|NCT01683058|Secondary|Mean Change in QRS Interval From Baseline in All Participants.|The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
1359655|NCT01683058|Secondary|Mean Change in RR Interval From Baseline in All Participants.|The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
1359656|NCT01683058|Secondary|Mean Change in PR Interval From Baseline in All Participants.|The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
1359657|NCT01683058|Secondary|Mean Change in Ventricular Rate From Baseline in All Participants.|The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||Beats/min||Standard Deviation|Mean
1359658|NCT01683058|Secondary|Mean Change in Diastolic BP From Baseline in All Participants.|The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
1359659|NCT01683058|Secondary|Mean Change in Systolic BP From Baseline in All Participants.|The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
1359660|NCT01683058|Secondary|Mean Change in Heart Rate From Baseline in All Participants.|The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||beats/min||Standard Deviation|Mean
1361886|NCT01661595|Other Pre-specified|Hematocrit Level Measured at Week 0|Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.|week 0||||percent of red blood cells||Standard Deviation|Mean
1359661|NCT01683058|Secondary|Mean Change in Diastolic Supine BP From Baseline in All Participants.|The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
1359662|NCT01683058|Secondary|Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.|The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
1359663|NCT01683058|Secondary|Mean Change in Heart Rate Supine From Baseline in All Participants.|The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||beats/min||Standard Deviation|Mean
1359664|NCT01683058|Secondary|Mean Change in Body Temperature From Baseline in All Participants.|The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||°C||Standard Deviation|Mean
1359665|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)|The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
1359666|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)|EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
1359667|NCT01683058|Secondary|Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)|The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
1359668|NCT01683058|Secondary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)|Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
1359670|NCT01683019|Secondary|Safety Profile of the Treatment|Describe the safety profile of the administration of low-emission sinusoidal magnetic fields above the subject's scalp. Safety criteria include adverse events, serious adverse events, and vital signs.|Outcome assessed at the end of the 4th week of treatment.|||||||
1359671|NCT01683019|Primary|Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.|"Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.~The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression."|Assessed at baseline and the end of Week 4 of treatment.|52 subjects were randomized into the study. Of those, 7 dropped in the first week due to difficulties driving to the study site. An intent-to-treat analysis was performed on the remaining 45 subjects.|||% change in HAM-D score||Standard Error|Mean
1359672|NCT01682954|Primary|Body Weight|Change in body weight|7 Months||||kg||Standard Error|Mean
1359673|NCT01682954|Primary|Body Weight|Change in body weight|4 months||||kg||Standard Error|Mean
1359674|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 422|Analysis was done on safety set|||Subjects|||Number
1359675|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 86|Analysis was done on Safety Set Unsolicited AEs|||Subjects|||Number
1359676|NCT01682876|Secondary|Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset|||Subjects|||Number
1359677|NCT01682876|Secondary|Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||subjects|||Number
1359678|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset|||Titers||95% Confidence Interval|Geometric Mean
1359679|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset|||percentages of subjects||95% Confidence Interval|Number
1359680|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset|||Titer||95% Confidence Interval|Geometric Mean
1359681|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset.|||percentage of subjects||95% Confidence Interval|Number
1359682|NCT01682876|Primary|Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.|One Month After Last Vaccination (day 86)|Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.|||percentage of subjects||95% Confidence Interval|Number
1359683|NCT01682876|Primary|Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|"Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart.~Seroresponse is defined as:~postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4;~for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer."|One Month After Last Vaccination ( day 86)|Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||percentage of subjects||95% Confidence Interval|Number
1359701|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54|The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||Percentage of participants||95% Confidence Interval|Number
1359684|NCT01682863|Secondary|Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Number of puffs||Standard Error|Least Squares Mean
1359685|NCT01682863|Secondary|Change From Baseline in Mean Total Daily Symptom Scores|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Score on a scale||Standard Error|Least Squares Mean
1359686|NCT01682863|Secondary|Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation|Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis.|||Percentage of participants|||Number
1359687|NCT01682863|Secondary|Change From Baseline in FVC Measurement at All Post-baseline Time Points|Pulmonary function assessments were performed using centralized spirometry according to international standards.|Day1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
1359688|NCT01682863|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
1359689|NCT01682863|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 29, 57,, 85, 141, 197, 253, 309 and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
1359690|NCT01682863|Secondary|Time to Premature Discontinuation of Treatment|methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl|56 weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
1359691|NCT01682863|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|56 weeks|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included.|||Number of Patients|||Number
1359692|NCT01682837|Secondary|Central Aortic Diastolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
1359693|NCT01682837|Secondary|Central Aortic Systolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
1359694|NCT01682837|Secondary|Carotid to Femoral Pulse Wave Velocity||4 weeks||||m/s||Standard Deviation|Mean
1359695|NCT01682837|Secondary|24-hour Urinary Calcium||4 weeks of treatment||||mg/day||Standard Deviation|Mean
1359696|NCT01682837|Secondary|Serum C-terminal Telopeptide (CTX)||4 weeks||||ng/ml||Standard Deviation|Mean
1359697|NCT01682837|Secondary|Office Diastolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
1359698|NCT01682837|Secondary|Office Systolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
1359699|NCT01682837|Primary|24-hour Average Diastolic Blood Pressure|The average diastolic blood pressure over a 24 hour period.|4 weeks||||mmHg||Standard Deviation|Mean
1359700|NCT01682837|Primary|24-hour Average Systolic Blood Pressure|This is the average systolic blood pressure over a 24 hour period.|4 weeks|All participants who completed the study completed all 4 phases.|||mmHg||Standard Deviation|Mean
1359702|NCT01682759|Secondary|Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue||Baseline and Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||kg||95% Confidence Interval|Least Squares Mean
1359703|NCT01682759|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue|Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).|Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Percentage of participants|||Number
1359704|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||Percentage of participants||95% Confidence Interval|Number
1359705|NCT01682759|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 54|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).|Baseline and Week 54|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
1359706|NCT01682759|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue||Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Percentage of participants|||Number
1359707|NCT01682759|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 57|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Percentage of participants|||Number
1359708|NCT01682759|Primary|Change From Baseline in Hemoglobin A1C at Week 54|Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.|Baseline and Week 54|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||A1C (%)||95% Confidence Interval|Least Squares Mean
1359709|NCT01682720|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group."|Up to Posttreatment Week 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.|||percentage of participants|||Number
1359710|NCT01682720|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.|||percentage of participants|||Number
1359711|NCT01682720|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1359712|NCT01682720|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.|||percentage of participants|||Number
1359713|NCT01682681|Secondary|Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More|Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.|Week 52|FAS population included all participants who met all the eligibility criteria.|||Percentage of participants||95% Confidence Interval|Number
1359714|NCT01682681|Secondary|Percentage of Participants Without Seizure|Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.|||Percentage of participants||95% Confidence Interval|Number
1359715|NCT01682681|Secondary|Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy|Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.|||Participants|||Number
1359716|NCT01682681|Secondary|Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)|Number of participants who received concomitant AEDs along with the topiramate were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.|||Participants|||Number
1361887|NCT01661595|Other Pre-specified|Hemoglobin Level Measured at Week 8|Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.|week 8||||g/dL||Standard Deviation|Mean
1359727|NCT01682603|Primary|Net Change of the Incontinence Impact Questionnaire (IIQ-7)|"Efficacy:~Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.~The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.~Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events"|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1359728|NCT01682603|Secondary|Net Change of the Postvoid Residual Volume (PVR)|"Efficacy:~Net change of the postvoid residual volume (PVR) from baseline and 12 months~Results:~Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.~Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.~Safety:~Systemic adverse events"|Baseline and 12 months||||mL||Standard Deviation|Mean
1359729|NCT01682603|Secondary|Net Change of the Detrusor Pressure (Pdet)|"Efficacy:~Net change of the detrusor pressure (Pdet) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||cmH2O||Standard Deviation|Mean
1359730|NCT01682603|Secondary|Net Change of the Void Volume|"Efficacy:~Net change of the void volume from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL||Standard Deviation|Mean
1359731|NCT01682603|Secondary|Net Change of the Maximum Flow Rate (Qmax)|"Efficacy:~Net change of the maximum flow rate (Qmax) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL/s||Standard Deviation|Mean
1359732|NCT01682603|Secondary|Net Change of the Bladder Compliance|"Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.~Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).~Efficacy:~Net change of the bladder compliance from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL/cmH2O||Standard Deviation|Mean
1359733|NCT01682603|Secondary|Net Change of the Cystometric Bladder Capacity (CBC)|"Efficacy:~Net change of the cystometric bladder capacity (CBC) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL||Standard Deviation|Mean
1359734|NCT01682603|Primary|Net Change of the Urinary Distress Inventory (UDI-6)|"Efficacy:~Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.~The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.~The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events"|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1359735|NCT01682538|Secondary|Apparent Volume of Distribution (Vz/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||L||Full Range|Median
1359736|NCT01682538|Secondary|Oral Clearance (CL/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||L/h||Full Range|Median
1359737|NCT01682538|Secondary|Terminal Half-life|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||hours||Full Range|Median
1359738|NCT01682538|Secondary|Time to Reach C-Max (t-Max)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||hours||Full Range|Median
1359739|NCT01682538|Secondary|AUC From Time Zero to Infinity|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per-protocol set (bioequivalence) was used for fasted treatment groups and per-protocol set (food effect) for fed treatment group (all subjects with available PK data)|||h*uM||Full Range|Geometric Mean
1359740|NCT01682538|Secondary|The Maximum Serum Concentration (Cmax)|Measured for the Orfadin suspension treatment arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||nM||Full Range|Geometric Mean
1359741|NCT01682538|Secondary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h)|Measured for the Orfadin suspension treatments arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||uM*h||Full Range|Geometric Mean
1359742|NCT01682538|Primary|The Maximum Serum Concentration (Cmax) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||nM||Full Range|Geometric Mean
1359743|NCT01682538|Primary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||uM*h||Full Range|Geometric Mean
1359751|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)|1 month after using artificial tears||||units on a scale||Standard Deviation|Mean
1359752|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)|1 week after using artificial tears||||units on a scale||Standard Deviation|Mean
1359744|NCT01682512|Secondary|PK (Part I Only): AUC0-inf, Ppk (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Based on Individual Predicted Concentrations for Missing Data Derived From a Population PK Model, Determined Over Both Dosages)|PK (Part I only): AUC0-inf, ppk. Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. A modeling approach was used to impute missing values as well as impute missing concentrations after the first dose with a sampling schedule identical to the first 2 weeks after the second dose. A unit dose of 1000 mg was used in calculating the imputed values. The resulting dataset thus consisted of PK evaluable and PK non-evaluable patients with both measured as well as imputed concentration values. The prediction of these concentrations was based on a mixed effect modeling approach and included significant covariates as identified during the PK model development (including age, body surface area [BSA], body mass index [BMI], weight, gender, race, and formulation).|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|Pharmacokinetic full analysis set (PKFS) included all randomized subjects with at least one valid PK concentration measurement. A valid PK concentration measurement is a value greater than lower limit of quantification as provided by Charles River.|||h*ug/mL||Geometric Coefficient of Variation|Geometric Mean
1359745|NCT01682512|Secondary|Percentage of Patients Meeting the ACR20 (American College of Rheumatology 20% Response Criteria) at Week 24 in Both Part-I and II|"A subject has an ACR20 response if all of the following occur:~a > 20% improvement in the swollen joint count (66 joints)~a > 20% improvement in the tender joint count (68 joints)~a > 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (C-reactive protein).~The percentage of subjects meeting the ACR20 response criteria at Week 24 (part-I and II) is presented for subjects randomised to receive BI 695500, Rituxan and MabThera."|Week 24|FAS. Missing data have been imputed according to LOCF (last observation carried forward) and/or NRI (Non Responder Imputation).|||Percentage of participants|||Number
1359746|NCT01682512|Primary|PK (Part I Only): Observed Cmax (Maximum Plasma Concentration, Determined After the Second Dose)|PK (Part I only): observed Cmax (observed maximum plasma concentration, determined after the second dose). Only subjects randomized in part I of this study are included.|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|PKS|||microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
1359747|NCT01682512|Primary|PK (Part I Only): AUC0-336 (Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours)|PK (Part I only): AUC0-336 (area under the plasma concentration versus time curve from time zero to 336 hours after the first dose). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|PKS|||h*ug/mL||Geometric Coefficient of Variation|Geometric Mean
1359748|NCT01682512|Primary|PK (Part I Only): AUC0-inf Pred (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Determined Over Both Dosages)|PK (Part I only): AUC0-inf pred (area under the plasma concentration versus time curve from time zero to infinity, determined over both dosages, and extrapolated to infinity using predicted last observed quantifiable concentration). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|PKS|||h*ug/mL||Geometric Coefficient of Variation|Geometric Mean
1359749|NCT01682512|Primary|PK (Part I Only): AUC0-tz (Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration, Determined Over Both Dosages)|"Pharmacokinetic (PK) (Part I only): AUC0-tz (area under the plasma concentration versus time curve from time zero to the last measurable concentration, determined over both dosages). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. As per protocol all the following criteria had to be fulfilled for a patient to be defined as PK evaluable for the Pharmacokinetic analysis set (PKS):~Full first and second dose given. Pre-dose concentration available prior to the second dose. Ability to estimate AUC during the infusion phases. Ability to estimate the AUC for the distribution phase after the second dose. Ability to estimate the terminal half-life (t1/2) after the second dose.~gMean - Geometric Mean"|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|Pharmacokinetic analysis set (PKS) consisted of all randomized subjects who were PK evaluable based on protocol defined criteria.|||Hour(h)*Microgram(ug)/Milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1359750|NCT01682512|Primary|Change of Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 [ESR]) From Baseline to Week 24 (BI 695500 Versus Rituxan®) - Part I|"The DAS28 score was derived using the formula: DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.70*ln(ESR) + 0.014*(GH), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the General Health component of the DAS [score on a visual analogue scale (VAS) ranging from 0 (very well) to 100 (very poor)].~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Low disease activity is defined as a DAS28 score of ≤ 3.2 and DAS28 remission is defined as a DAS28 score of < 2.6. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2.~The full analysis set (FAS) contained all randomized subjects who received at least one dose of trial medication, had at least one assessment of primary efficacy endpoint at Baseline and at post-baseline visit prior or at Week 24 visit."|Baseline and Week 24|FAS. Since this endpoint was designed to establish statistical equivalence of efficacy of BI 695500 and Rituxan®, only subjects randomized to BI 695500 and Rituxan® in part-I of study are included.|||Unit on scale||90% Confidence Interval|Least Squares Mean
1361888|NCT01661595|Other Pre-specified|Hemoglobin Level Measured at Week 4|Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.|week 4||||g/dL||Standard Deviation|Mean
1359753|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score)."|1 month after using artificial tears||||units on a scale||Standard Deviation|Mean
1359754|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score)."|1 week after using artificial tears||||units on a scale||Standard Deviation|Mean
1359755|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)|At baseline (dispensing visit)||||units on a scale||Standard Deviation|Mean
1359756|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score)."|At baseline (dispensing visit)||||units on a scale||Standard Deviation|Mean
1359757|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 month||||seconds||Standard Deviation|Mean
1359758|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 week||||seconds||Standard Deviation|Mean
1359759|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|At baseline (dispensing visit)||||seconds||Standard Deviation|Mean
1359760|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 month||||units on a scale||Standard Deviation|Mean
1359761|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 week||||units on a scale||Standard Deviation|Mean
1359762|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|At baseline (dispensing visit)||||units on a scale||Standard Deviation|Mean
1359763|NCT01682135|Secondary|Number of Participants With Best Objective Response (BOR)|Participants achieved disease control if they had a BOR of CR, PR or SD. Progressive Disease (PD) and those participants which were Not Evaluable (NE) were also reported. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug.|||Participants|||Number
1359764|NCT01682135|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion|All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data.|||Participants|||Number
1359765|NCT01682135|Secondary|Time to Disease Progression|Time to progressive disease was measured from the start of study drug until progressive disease. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. Censoring for Cohort 1, 2 and 3: 3, 2 and 2, respectively.|||Months||95% Confidence Interval|Median
1359766|NCT01682135|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug and had evaluable SD data. Participants censored for Cohort 1, 2, and 3: 3, 2, and 1, respectively.|||Months||95% Confidence Interval|Median
1361889|NCT01661595|Other Pre-specified|Hemoglobin Level at Week 0|Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.|week 0||||g/dL||Standard Deviation|Mean
1359767|NCT01682135|Secondary|Duration of Response|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant’s last objective tumor assessment prior to that cut-off date.|Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. There were no participants censored due to no CR or PR responses.|||Months||95% Confidence Interval|Median
1359768|NCT01682135|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab|Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss])|Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable AUC(0-∞) for Cycle 1 and AUC(τ,ss) for Cycle 2 PK data.|||Microgram*day/milliliter (µg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
1359769|NCT01682135|Primary|Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab||Cycle 2-5: Predose|All enrolled participants who received at least one dose of study drug and had evaluable Cmin PK data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1359770|NCT01682135|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable Cmax pharmacokinetics (PK) data.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1359771|NCT01682135|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)|A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.|Baseline through Study Completion (Up to 12 Weeks)|All enrolled participants who received at least one dose of study drug.|||Participants|||Number
1359772|NCT01682044|Secondary|Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline|Mean percent change in MFI level from baseline.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
1359773|NCT01682044|Secondary|Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline|Mean percent change in INF level from baseline.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
1359774|NCT01682044|Secondary|Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline|Mean percent change in TNF level from baseline at each visit.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
1359775|NCT01682044|Secondary|Percent Change in CD20 Antigen Expression and Density of Expression|Percent change in CD20 antigen expression and density of expression|At 4 years|Samples tissues were not large enough to perform analysis. No participants were analyze.||||||
1359776|NCT01682044|Secondary|Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline|Mean percent change in CD11b level from baseline at each visit|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
1359777|NCT01682044|Secondary|Overall Response Rate|Overall Response is defined as Complete Response: During observation, no disease is apparent, including measurable and non-measurable disease, and no evidence of disease is observed for at least 28 days, as confirmed by a second assessment following the original observation of no disease; and Partial Response: A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the 50% or greater decrease, and no appearance of new lesions is noted.|Up to 43 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1359778|NCT01682044|Primary|Number of Participants With Adverse Events|Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE|Up to 90 days after the last dose of study drugs|All treated and eligible patients|||Participants|||Count of Participants
1359779|NCT01682031|Secondary|Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)|Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.|Up to 3 months post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1359780|NCT01682031|Secondary|CRT Dose Delivery|This characteristic will be included in Cox models.|Up to 8 weeks|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1359781|NCT01682031|Secondary|Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years post-treatment|All treated and eligible patients|||number of xerostomia events|||Number
1359782|NCT01682031|Secondary|Quality of Life||Up to 1 year post-treatment|Due to the study's early termination and inadequate number of patients, no patients were analyzed.||||||
1362158|NCT01658228|Other Pre-specified|Trails A and B|Parts A and B are composed of 25 circles. Patients are asked to scan the entire page and identify the next number or letter in a sequence.|Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
1359783|NCT01682031|Secondary|Overall Survival|Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1359784|NCT01682031|Secondary|Relapse-free Survival (RFS)|Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.|At 1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1359785|NCT01682031|Secondary|Tumor Complete Response Rate|Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1359786|NCT01682031|Primary|Incidence of >= Grade 3 Mucositis|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1359787|NCT01681992|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.|From Day 0 through the end of the study (Day 222)|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359788|NCT01681992|Secondary|Number of Subjects Reporting Any AEs of Specific Interest|AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.|From Day 0 through the end of the study (Day 222)|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359789|NCT01681992|Secondary|Number of Subjects Reporting Any Unsolicited AES Post Dose 2|Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359790|NCT01681992|Secondary|Number of Subjects Reporting Any Unsolicited AES Post Dose 1|Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359791|NCT01681992|Secondary|Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2|Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359792|NCT01681992|Secondary|Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1|Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359793|NCT01681992|Secondary|Number of Subjects Reporting Any Rash Post Dose 2|Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359794|NCT01681992|Secondary|Number of Subjects Reporting Any Rash Post Dose 1|Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359795|NCT01681992|Secondary|Number of Subjects Reporting Any Fever Post Dose 2|Any fever = Fever (axillary) ≥ 38°C.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359796|NCT01681992|Secondary|Number of Subjects Reporting Any Fever Post Dose 1|Any fever = Fever (axillary) ≥ 38°C.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359797|NCT01681992|Secondary|Number of Subjects With Any Solicited General AEs Post Dose 1|Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 15-day (Days 0-14) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359798|NCT01681992|Secondary|Number of Subjects With Any Solicited Local AEs Post Dose 2|Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359799|NCT01681992|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1|Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Total Vaccinated cohort (TVC) included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
1359800|NCT01681992|Secondary|Anti-rubella Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in IU/mL.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||IU/mL||95% Confidence Interval|Geometric Mean
1359801|NCT01681992|Secondary|Anti-mumps Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in EU/mL.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||EU/mL||95% Confidence Interval|Geometric Mean
1359802|NCT01681992|Secondary|Anti-measles Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||mIU/mL||95% Confidence Interval|Geometric Mean
1359803|NCT01681992|Secondary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
1359804|NCT01681992|Secondary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
1359805|NCT01681992|Secondary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration < 150 mIU/mL) before dose 1.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
1359806|NCT01681992|Primary|Anti-rubella Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in IU/mL.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||IU/mL||97.5% Confidence Interval|Geometric Mean
1359807|NCT01681992|Primary|Anti-mumps Virus Antibody Concentrations (by PRNT)|Antibody concentrations were expressed as Geometric Mean Titers (GMTs).|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Titers||95% Confidence Interval|Geometric Mean
1359808|NCT01681992|Primary|Anti-mumps Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in EU/mL.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||EU/mL||97.5% Confidence Interval|Geometric Mean
1359809|NCT01681992|Primary|Anti-measles Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||mIU/mL||97.5% Confidence Interval|Geometric Mean
1359810|NCT01681992|Primary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||97.5% Confidence Interval|Number
1359811|NCT01681992|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])|For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration < 2.5 ED50) before dose 1.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
1359812|NCT01681992|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||97.5% Confidence Interval|Number
1359813|NCT01681992|Primary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])|For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.|At Day 42|According-to-protocol (ATP) cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||97.5% Confidence Interval|Number
1359814|NCT01681849|Secondary|Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM)|Participants were exposed to traumatic scripts versus neutral scripts before and after treatment with paroxetine or placebo. Brain blood flow was measured using statistical parametric mapping (SPM) which analyzes brain imaging data sequences. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. Data for each participant can not be generated using this software and therefore are not available to summarize in the data table below. Regional blood flow was compared for stress and neutral conditions and before and after treatment with paroxetine or placebo. Higher z-scores indicate an increase in regional blood flow to the medial prefrontal cortex under stress conditions for the 3 month time point relative to baseline. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group.|Baseline, 3 Months Post Treatment|Statistical analyses yielded image data sets in which the values assigned to individual voxels correspond to the t-statistic of the difference in brain blood flow between conditions. Statistical images were displayed with values of z score units.|||z-scores|||Number
1359815|NCT01681849|Primary|Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score|The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional. CAPS score is based on items 1-17, CAPS score has a potential range of 0-136, with higher scores indicating greater severity of PTSD symptoms. CAPS was performed before and after treatment with paroxetine or placebo in PTSD patients.|Baseline, End of Study (Up to 52 Weeks)|Data for participants who completed all study visits were analyzed.|||units on a scale||Standard Deviation|Mean
1359816|NCT01681628|Post-Hoc|Assessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of >50.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. Only the wait-list control group was used as the treatment group did not not have a run-in score, and would have given inappropriately positive results.|Time 2 and 19 months later.|83% female average age 43 years, 17% male average age 46.7 years.|||percentage of PCL-C scores >50.|||Number
1359817|NCT01681628|Post-Hoc|Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C one week following treatment and nineteen months later. Comparison of PCL-C scores at nineteen months compared to one week following treatment.|1 week post-treatment (Time 2, TFT; Time 3, WL) and 19 months later.|All those who had scores one week after treatment and at 19 months. Similar gender and age proportions to original groups.|||units on a scale (PCL-C score)||Standard Deviation|Mean
1359843|NCT01681277|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1359818|NCT01681628|Secondary|Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.|Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)|Participants with symptoms suggestive of PTSD, thought field therapy group treated, wait list group not treated, and wait-list group treated. All assessed one week after initial assessment and treatment, and the percentage with a score > 50 compared before and after treatment, or control.|||percentage with PCL-C score > 50|||Number
1359819|NCT01681628|Primary|Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.|"PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.~In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2).~In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3)."|Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)|Participants with symptoms suggestive of PTSD, excluding non-attenders at Time 2. Non-attenders at time 3 were excluded from the wait-list (Thought Field Therapy) arm.|||units on a scale||Standard Deviation|Mean
1359820|NCT01681576|Secondary|Mean Sitting Pulse Pressure (PP) Over Time|Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmHg||Standard Deviation|Mean
1359821|NCT01681576|Secondary|Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time|Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmHg||Standard Deviation|Mean
1359822|NCT01681576|Secondary|Urine Volume (Diuresis) Over Time|Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28|Day -1, Day 1 & Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mL||Standard Deviation|Mean
1359823|NCT01681576|Secondary|Cumulative Sodium Excretion (Natriuresis) at Day 28|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28|0-6 and 0-24 hours on Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmol||Standard Deviation|Mean
1359824|NCT01681576|Primary|Cumulative Sodium Excretion (Natriuresis) at Day 1|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1|0-6 and 0-24 hours on Day 1|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmol||Standard Deviation|Mean
1359825|NCT01681511|Other Pre-specified|Organism Relation to CAUTI and TIC|Organisms found in relation to CAUTI events in TIC versus control.|up to 30th day from the time of catheterization||||participants|||Number
1359826|NCT01681511|Primary|The Proportion of Subjects With at Least One CAUTI|"CAUTI is as determined by blinded investigator assessment per protocol definition.~DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met.~Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD.~p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model.~Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.~CZD = Catheterized or catheter"|48 ± 24 hours or more||||participants|||Number
1359827|NCT01681511|Secondary|The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)|Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.|up to 30th day from the time of catheterization||||participants|||Number
1359844|NCT01681277|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS|||h||Full Range|Median
1359932|NCT01680991|Primary|Cmax of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1359828|NCT01681511|Secondary|The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)|Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells [WBC]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine|up to 30th day from the time of catheterization||||Participants|||Number
1359829|NCT01681511|Primary|Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.|"All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed.~Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP."|up to 30th day from the time of catheterization||||participants|||Number
1359830|NCT01681472|Primary|Comparison of Folate Concentration in Tumor Tissue and Adjacent Mucosa Between Treatment Arms.||Sample taken Day 1 (Day of surgery).|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
1359831|NCT01681368|Secondary|Total Clearance of Birinapant After Administration|Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|0-24hr||||L/hr||Full Range|Mean
1359832|NCT01681368|Secondary|Coexpression of Cleaved Caspase 3 and Gamma-H2AX in Fixed Specimens|Tumor biopsies were measured for cleaved caspase 3 and gamma-H2A.X by immunofluorescence microscopy. Fold change was calculated by comparing the post-treatment measurements to the pre-treatment levels.|Pre treatment and post treatment of Birinapant, approximately 0-6 weeks|Only 2 pairs of adequate pre- and post-treatment biopsy samples were available for analysis. The remaining paired samples were inadequate for immunohistochemistry because of necrotic debris in the post-treatment biopsy sample (1 specimen) or contamination with blood (4 specimens).|||Fold over baseline||Full Range|Median
1359833|NCT01681368|Secondary|Ratio of Phosphorylated NF-kappaB-p65 Protein to Total NF-kappaBp65 Protein in Tumor Biopsy Samples|Proteins were measured using capillary western blot and ratio was calculated between phosphorylated and total NF-kappaB p65. Core 1 tumor samples and peripheral blood mononuclear cells (PBMCs) from each time point were lysed in T-PER buffer (Thermo Scientific) for protein quantification by an automated capillary electrophoresis immunoassay system (Simple Western). The tumor protein lysate (40-60 ng) or PBMC protein lysate (16-77 ng) was analyzed according to the manufacturer’s instructions (ProteinSimple, Santa Clara, Calif).|0-6 weeks|4 patients refused second biopsy.|||pixel intensity per ng protein||Full Range|Mean
1359834|NCT01681368|Secondary|Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Plasma|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0-24hr||||L||Standard Deviation|Mean
1359835|NCT01681368|Secondary|Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Tumor Tissue|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0-24hr||||L||Full Range|Mean
1359836|NCT01681368|Secondary|Birinapant Concentration in Tumor Tissue|Levels of Birinapant were measured in core needle biopsies of tumor that had been frozen at the time of acquisition.|Prior to treatment and 12 to 22 hours following Cycle 2 Day 15|4 patients did not have the second paired biopsy due to patient refusal.|||ng/g||Full Range|Mean
1359837|NCT01681368|Secondary|Mean Plasma Concentration-Time Curve of Birinapant|Measurement of the plasma concentration of the Birinapant over time. It is used to characterize drug absorption. The single values were analyzed with liquid chromatography/tandem mass spectrometry via a proprietary methodology (TetraLogic Pharma,Malvern, Pa). The values were grouped and averaged for each of the patients to obtain the mean value for each time point.|30, 60, 120, 180 minutes after administration of first dose of Birinapant||||ng/mL||Standard Deviation|Mean
1359838|NCT01681368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months||||participants|||Number
1359839|NCT01681368|Primary|Objective Response (Complete Response (CR) or Partial Response (PR) Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria) or Disease Stabilization for Greater Than 6 Months|Per the RECIST criteria, CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months||||participants|||Number
1359840|NCT01681277|Secondary|RA,AUC|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1359841|NCT01681277|Secondary|RA,Cmax|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1359842|NCT01681277|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.|PKS|||h||Geometric Coefficient of Variation|Geometric Mean
1359845|NCT01681277|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PK analysis set (PKS): This set included all subjects of the TS who provided at least one observation for at least one secondary PK endpoint without important protocol violations.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1359846|NCT01681277|Primary|Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings|Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)|From administration of study drug until end-of-study, up to 17 days|Treated Set (TS)|||participants|||Number
1359847|NCT01681277|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study, up to 17 days|Treated set|||percentage of participants|||Number
1359848|NCT01681212|Secondary|Number of Patients Who Died and Who Had Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, Grade 3-4 AEs, and Related Grade 3-4 AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death.|First dose to 90 days following last dose of study drug. All deaths were poststudy, occurring more than 90 days after the last dose of study drug.|All participants who received at least 1 dose of study drug|||Participants|||Number
1359849|NCT01681212|Secondary|Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs are adverse events of unknown cause, consistent with an immune phenomenon, and considered to be causally related to drug exposure. Six subcategories of irAE are assessed: gastrointestinal, liver, skin, endocrine, neurologic, and other. The irAEs are programmatically determined from a predefined list of MedDRA terms. irAEs will be measured every 3 weeks in induction phase, every 6 weeks in Maintenance Phase to Week 48, and every 12 weeks until Progressive Disease. Grading criteria: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|First dose to 90 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
1359850|NCT01681212|Primary|Percentage of Participants Surviving at 1 Year|Survival rate=percentage of participants surviving at 1 year following start of study drug. Every effort was made to collect survival data on all patients, including those withdrawn from treatment for any reason. If the death of a patient was not reported, the patient's last known alive date was recorded. Confidence intervals were computed using the Clopper-Pearson method.|At 1 year from start of study drug|All participants who received at least 1 dose of study drug.|||Percentage of participants||90% Confidence Interval|Number
1359851|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
1359852|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
1359853|NCT01681121|Secondary|Evaluate the Safety and Tolerability of ADX-N05 vs Placebo in Adults With Narcolepsy by Assessing Treatment Emergent Adverse Events, Vital Signs, Laboratory Results, ECGs, and Physical Exams.||12 weeks|||||||
1359854|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
1359855|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
1359856|NCT01681121|Secondary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
1359857|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
1359858|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
1359859|NCT01681121|Secondary|Evaluate the Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo||4 weeks|||||||
1359860|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
1359861|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
1359862|NCT01681121|Primary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
1359863|NCT01681121|Primary|Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test for ADX-N05 vs. Placebo at Last Assessment.|Sleep Latency - The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.|Baseline and 12 weeks|93 subject were randomly assigned to a treatment group; 90 subjects (43 on ADX-N05 and 47 on Placebo) had at least one post-Basdeline efficacy assessment (Intent-to-treat [ITT] Population). For the primary endpoint analysis (40 on ADX-N05 and 45 on Placebo) have assessment week 12/last assessment|||Minutes||Standard Deviation|Mean
1359864|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured 48 hours post-operative|48 hours post procedure|Only patients for whom 48-hour Troponin-I values were available were included in analysis|||ng/mL||Standard Deviation|Mean
1359870|NCT01681095|Secondary|Myocardial Infarction|Number or participants fulfilling at least two of the following 3 criteria: (1) CK-MB of 100 ug/L or more and/or troponin-I of 3.0 ug/L or more, (2) appearance of new postoperative Q waves on the EKG of more than 0.03 seconds, and (3) a new hypokinetic or akinetic area in the left or right ventricle by echocardiography.|up to 36 hours post procedure||||participants|||Number
1359871|NCT01681095|Secondary|Intensive Care Unit (ICU) Length of Stay|Duration of stay in ICU, from ICU admission to ICU discharge|up to 100 days after admission||||days||Inter-Quartile Range|Median
1359872|NCT01681095|Secondary|Postoperative Inotropic Infusion >20 Minutes|Number of patients receiving vasopressor or inotropic infusion for greater than 20 minutes in the operating room, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine.|during operative procedure||||participants|||Number
1359873|NCT01681095|Secondary|Duration of Vasopressor / Inotropic Agent|Total time in minutes on any vasopressor or inotropic agent, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine|up to 36 hours post procedure|Patients not receiving any vasopressors are excluded from this analysis|||minutes||Inter-Quartile Range|Median
1359874|NCT01681095|Secondary|Time on Mechanically Assisted Ventilation|time in hours from intubation to extubation, with intervening transport to the cardiac critical care unit.|up to 36 hours post procedure||||hours||Inter-Quartile Range|Median
1359875|NCT01681095|Secondary|Cardiovascular Mortality|Number of participants with cardiovascular-related mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative|30 days post procedure||||participants|||Number
1359876|NCT01681095|Secondary|All Cause Mortality|Number of participants with all-cause mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative|30 days post procedure||||participants|||Number
1359877|NCT01681095|Secondary|Cardiac Dysrhythmias|Number of participants with new or worsening of cardiac dysrhythmias|up to 36 hrs post surgery||||participants|||Number
1359878|NCT01681095|Primary|Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)|LV ejection fraction by TTE, difference from baseline at 24 hours post surgery|Baseline and 24 hours post surgery|patients for whom both preoperative and 24 hour LV ejection fractions were obtained|||% LV volume||Standard Deviation|Mean
1359879|NCT01681095|Primary|Change in Troponin I|Troponin I values, difference from baseline 7 hours post surgery|Baseline and 7 hours post surgery||||ng/mL||Inter-Quartile Range|Median
1359880|NCT01681095|Primary|Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB)|Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery|Baseline and 7 hours post surgery|Patients for which both baseline and 7 hours post surgery values were available|||ng/mL||Inter-Quartile Range|Median
1359881|NCT01681069|Secondary|Change in Mean Body Fat at End of Study From Baseline|Measured in kg using calibrated weighing scales|12 weeks||||kg||Standard Deviation|Mean
1359882|NCT01681069|Secondary|Change in Waist Circumference (in cm) at End of Study From Baseline|Difference in waist circumference (in cm) at end of study from baseline|12 weeks||||cm||Standard Deviation|Mean
1359883|NCT01681069|Primary|Change in Body Weight at End of Study Compared to Baseline|Change in body weight at the end of study compared to baseline|12 weeks||||kg||Standard Deviation|Mean
1359884|NCT01681030|Secondary|Number of Participants With Adverse Events Potentially Related to Thrombotic Events|The number of subjects with an adverse event potentially related to a thrombotic event|30 days (+ 14 days) following surgery||||Participants|||Count of Participants
1359885|NCT01681030|Secondary|Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment|The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment|Intra-operative, prior initiation of final chest wall closure. Safety Issue:|Subjects who established TBS hemostasis at 3 minutes|||Participants|||Count of Participants
1359886|NCT01681030|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application|Number of subjects achieving hemostatic success at 10 minutes following treatment application.|Intraoperative, 10 minutes following treatment application||||Participants|||Count of Participants
1359887|NCT01681030|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 6 minutes following treatment application.|Intraoperative, 6 minutes following treatment application||||Participants|||Count of Participants
1359888|NCT01681030|Primary|Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.|Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur|Intraoperative, 3 minutes following treatment application||||Participants|||Count of Participants
1359889|NCT01681004|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.|Procedure, discharge, 1, 3, 6, 12, 18 and 24 months|All treated study subjects.|||Participants|||Count of Participants
1359890|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
1359891|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|18 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
1359892|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
1359893|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
1359894|NCT01681004|Secondary|Work Status|"Non-working subjects (due to back pain or other reasons) who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|3 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
1359895|NCT01681004|Secondary|Work Status|"Proportion of non-working (due to back pain or other reasons) subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|1 month|Patients not working at baseline due to back or other pain. Note this is a subset of the entire population.|||Participants|||Count of Participants
1359896|NCT01681004|Secondary|Ambulatory Status|"Time to full ambulation among those without full ambulation at baseline.~60 days was the median of time to full ambulation for the iFuse implant System arm."|24 months (surgical group), 6 months (non-surgical group)|Number of days to full ambulation among those without full ambulation at baseline. At baseline only 13 in the surgical arm were not Ambulatory without assistance and for the NSM group, it was only 5 at baseline.|||Days, median||95% Confidence Interval|Median
1359897|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 months|13 iFuse subjects did not complete the 24-month assessment. Analysis was not done for the NSM group at 24 months due to the high crossover rate.|||units on a scale||Standard Deviation|Mean
1359898|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|2 iFuse subjects did not complete the survey at month 12. Due to high crossover rate to surgery, analysis in the NSM group is not valid.|||units on a scale||Standard Deviation|Mean
1359899|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 months|Results show improvement in score from baseline.|||units on a scale||Standard Deviation|Mean
1359900|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 months|Change in QOL score at 24 months. 89 participants had QOL information at 24 months. Analysis of the NSM cohort is not done because high crossover to surgery prevents valid analysis.|||units on a scale||Standard Deviation|Mean
1359901|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|A total of 2 iFuse subjects had exited the study before making it to their 12 month visit. This outcome is not evaluated in the NSM group at month 12 because high crossover to surgical treatment prevents valid analysis.|||units on a scale||Standard Deviation|Mean
1359902|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 months|2 iFuse and 2 NSM subjects did not complete SF-36 at month 6.|||units on a scale||Standard Deviation|Mean
1359903|NCT01681004|Secondary|Improvement in Back Dysfunction|Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|24 Months|The Count of participants = number of subjects that had a threshold change in ODI score of greater than or equal to 15 points. Overall number of participants = number of subjects analyzed. Of the 102, a total of 13 iFuse Implant subjects exited the study and 1 did not complete the ODI survey. By 6 months, 39 NSM subjects crossed over to surgical.|||Participants|||Count of Participants
1359904|NCT01681004|Secondary|Improvement in Back Dysfunction|Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|12 Months|2 iFuse subjects did not complete ODI at month 12. ODI analysis is not valid in NSM group at 12 months because of high crossover.|||Participants|||Count of Participants
1359905|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 Months|1 iFuse and 2 NSM subjects did not complete ODI at month 6.|||Participants|||Count of Participants
1359906|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at month 3.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|3 Months|2 iFuse subjects and 3 NSM subjects did not complete ODI at month 3.|||Participants|||Count of Participants
1359907|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at month 1.~Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|1 month|2 iFuse and 1 NSM subjects did not complete ODI at 1 month|||Participants|||Count of Participants
1359908|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 24 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|24 Months|12 iFuse subjects did not complete the 24-month pain score. Analysis of 24-month scores in the NSM group is not valid because of the high crossover rate.|||Participants|||Count of Participants
1359909|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 12 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|12 Months|2 iFuse subjects did not complete the 12-month pain score. Analysis of 12-month scores in the NSM group is not valid because of the high crossover rate.|||Participants|||Count of Participants
1359910|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 6 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|6 Months|1 iFuse and 3 NSM subjects did not complete the 6-month pain score.|||Participants|||Count of Participants
1359911|NCT01681004|Secondary|Improvement in Si Joint Pain VAS Score at 3 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|3 Months|2 iFuse and 3 NSM subjects did not complete the 3-month pain score.|||Participants|||Count of Participants
1359912|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 1 Month|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|1 month|2 iFuse and 1 NSM subjects did not complete the pain score.|||Participants|||Count of Participants
1359913|NCT01681004|Primary|Subject Success|Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.|6 months|A modified intent-to-treat approach was used.|||Participants|||Count of Participants
1359914|NCT01680991|Secondary|Time to Recovery of CD19+ B-cell|Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|"Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n represents the number of participants evaluable for the specified category."|||days||Standard Deviation|Mean
1359915|NCT01680991|Secondary|Duration of Depletion of CD19+ B-cell|Depletion is defined as CD19+ B-cell count < 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||days||Standard Deviation|Mean
1362159|NCT01658228|Other Pre-specified|WMS-III Visual Reproduction Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
1359916|NCT01680991|Secondary|Number of Participants With B-cell Depletion or Recovery|Depletion is defined as cluster of differentiation (CD) 19+ B-cell count <0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population.|||participants|||Number
1359917|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)|Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.|Cycle 1, Day 1|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
1359918|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Human Antibodies (HAHA)|For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.|Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up|"Safety analysis population. n represents the number of participants who were evaluable at the specified time point."|||participants|||Number
1359919|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.|||percentage of participants||95% Confidence Interval|Number
1359920|NCT01680991|Secondary|Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL <4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu >1.5 x 10^9/L without the need for EGF, ii. Plt >100 x 10^9/L without the need for EGF, and iii. Hb >11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.|||percentage of participants||95% Confidence Interval|Number
1359921|NCT01680991|Secondary|Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants|||percentage of participants||95% Confidence Interval|Number
1359922|NCT01680991|Secondary|Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (<) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] >1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) >100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) >11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.|||percentage of participants||95% Confidence Interval|Number
1359954|NCT01680783|Other Pre-specified|ICU Complications|ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness|6 weeks|||||||
1359923|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
1359924|NCT01680991|Secondary|Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN >1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
1359925|NCT01680991|Secondary|Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
1359926|NCT01680991|Secondary|Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (>) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
1359927|NCT01680991|Secondary|Minimum Observed Serum Concentration of Obinutuzumab||Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1|"PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and n is the number of participants evaluable at the specified time point."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1359928|NCT01680991|Secondary|Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
1359929|NCT01680991|Secondary|Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8|Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1359930|NCT01680991|Secondary|Apparent Terminal Half-life (t1/2)|Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||day||Geometric Coefficient of Variation|Geometric Mean
1359955|NCT01680783|Secondary|Intensive Care Unit Length of Stay|Number of days admitted to a medical intensive care unit|4 weeks||2018-06-30|06/2018||||
1359956|NCT01680783|Secondary|Hospital Mortality|Death from any cause during hospitalization at time of enrollment|6 weeks||2018-06-30|06/2018||||
1359933|NCT01680991|Primary|Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1359934|NCT01680991|Primary|Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1359935|NCT01680991|Primary|Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.|||day*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1359936|NCT01680900|Primary|Daily Diary Ratings of Severity of Hot Flashes|Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe).|Week 8.|all participants randomized to treatment|||units on a scale||95% Confidence Interval|Mean
1359937|NCT01680900|Other Pre-specified|Sheehan Global Ratings of Symptom (Hot Flash)Interference|Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.|Change from Baseline at Week 8|||||||
1359938|NCT01680900|Other Pre-specified|Percentage of Participants That Were Satisfied or Very Satisfied|Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).|Week 8|all participants with at least one treatment response.|||percentage of participants|||Number
1359939|NCT01680900|Other Pre-specified|Number of Participants With Adverse Events|A 17 item checklist of general adverse and withdrawal symptoms. It will be used at baseline and Week 12. Adverse events will be obtained by subject report at Week 4 and Week 8.|Baseline and Week 12||||participants|||Number
1359940|NCT01680900|Secondary|Menopause-related Quality of Life (MENQOL)|The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory. Each of 29 items is rated on a scale of 0 to 6 (extremely bothersome). The items are divided into 4 subscales. The item scores are summed in each subscale and means are computed for the 4 subscales. The total score is the sum of the mean subscale scores. Higher scores are more symptomatic.|Week 8||||units on a scale||95% Confidence Interval|Mean
1359941|NCT01680900|Secondary|Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes|Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries|Percent change from baseline at Week 8|all participants with at least one treatment response|||percentage of participants|||Number
1359942|NCT01680900|Primary|Daily Diary Ratings of Frequency of Hot Flashes|Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported.|Week 8.|all participants randomized to treatment|||number of hot flashes||95% Confidence Interval|Mean
1359943|NCT01680861|Secondary|Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)||during the first 12 months post-transplant|Note: one patient in the Tacrolimus/EC-MPS arm discontinued EC-MPS at 12 months post-transplant following a colon cancer diagnosis and the necessity to receive chemotherapy.|||participants|||Number
1359944|NCT01680861|Secondary|eGFR (Renal Function) at 6 Months Post-transplant|using the abbreviated MDRD formula.|at 6 months post-transplant||||ml/min per 1.73 m2||Standard Error|Mean
1359945|NCT01680861|Secondary|eGFR (Renal Function) at Month 3 Post-transplant|Renal function as determined by the estimated glomerular filtration rate (eGFR) at 3 months post-transplant, using the abbreviated MDRD formula.|at 3 months post-transplant||||ml/min per 1.73 m^2||Standard Error|Mean
1359946|NCT01680861|Secondary|eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.|using the abbreviated MDRD formula.|at 1 month post-transplant||||ml/min per 1.73 m2||Standard Error|Mean
1359947|NCT01680861|Secondary|Graft Loss (Return to Permanent Dialysis or Death)||during the first 12 months post-transplant||||participants|||Number
1359948|NCT01680861|Secondary|Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant|Incidence of (biopsy-proven) chronic allograft nephropathy (CAI) [interstitial fibrosis and tubular atrophy, using standard Banff criteria] at 12 months post-transplant.|1 year||||participants|||Number
1359949|NCT01680861|Primary|BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant|BPAR (biopsy-proven acute rejection) incidence during the first 12 months post-transplant. Grading is determined using standard Banff criteria.|1 year||||participants|||Number
1359950|NCT01680848|Primary|Percentage of Participants Who Indicate Surgical Intervention||Up to 24 months||||percentage of the dentists|||Number
1359951|NCT01680783|Other Pre-specified|Improvement of Oxygenation|Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100|2 weeks|||||||
1359952|NCT01680783|Other Pre-specified|Discharge Location|Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to|6 weeks|||||||
1359953|NCT01680783|Other Pre-specified|Readmission to the Intensive Care Unit|Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment|6 weeks|||||||
1359958|NCT01680783|Secondary|Functional Status After Discharge|Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)|Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)||2018-06-30|06/2018||||
1359959|NCT01680783|Secondary|Hospital Length of Stay|Days spent in hospital at time of enrollment|Duration of hospital stay||2018-06-30|06/2018||||
1359960|NCT01680783|Primary|Need for Endotracheal Intubation|Number of patients requiring endotracheal intubation after application of helmet device|6 weeks||||Participants|||Count of Participants
1359961|NCT01680666|Secondary|Time to Successful Cannulation||Up to 410 seconds||||seconds||Full Range|Mean
1359962|NCT01680666|Secondary|Patients With Complications|The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.|Up to 410 seconds||||Participants|||Count of Participants
1359963|NCT01680666|Secondary|Patients With Arterial Punctures|The count (%) of patients with arterial punctures is presented.|Up to 410 seconds||||Participants|||Count of Participants
1359964|NCT01680666|Secondary|Success of Central Venous Cannulation Within First Three Attempts|The count (%) of patients with successful central venous cannulation within the first three attempts is reported.|Up to 410 seconds||||Participants|||Count of Participants
1359965|NCT01680666|Primary|Success of Central Venous Cannulation at First Attempt|The count (%) of patients with successful central venous cannulation at first attempt is reported.|Up to 410 seconds||||Participants|||Count of Participants
1359966|NCT01680653|Other Pre-specified|Prolonged Episodes of Hypoglycemic Events|Prolonged hypoglycemia is defined as glucose readings of either <70 mg/dL for greater than one hour on and off the device, <70 mg/dL for greater than 2 hours on and off the device, <50 mg/dL that lasted longer than 30 minutes on and off the device and readings of <50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights.|8 hours at night||||events|||Number
1359967|NCT01680653|Secondary|Duration of Glucose Readings <70 mg/dl|Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.|8 Hours||||minutes|Hypoglycemic events|Inter-Quartile Range|Median
1359968|NCT01680653|Primary|Duration of Nocturnal Hypoglycemia|Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.|8 hours||||minutes|Hypoglycemic events|Inter-Quartile Range|Median
1359969|NCT01680549|Secondary|Patient Restfulness|Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.|3 days||||Percent(%) of participants|||Number
1359970|NCT01680549|Secondary|Knee Range of Motion|Patient knee range of motion was assessed on postoperative days 0, 1 and 2.|3 days||||Degrees||Standard Deviation|Mean
1359971|NCT01680549|Secondary|Narcotics Consumption|Narcotics consumption was recorded on postoperative days 0, 1, and 2.|3 days||||Morphine dose equivalents||Standard Deviation|Mean
1359972|NCT01680549|Primary|Patient Pain Scores|"Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.~Scale range: 0-100 Higher Values = More Pain"|3 days||||units on a scale- VAS||Standard Deviation|Mean
1359973|NCT01680497|Secondary|Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale|Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).|Day 0, Day 14, Month 12, Month 12.5|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
1359974|NCT01680497|Secondary|Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale|Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
1359975|NCT01680497|Secondary|Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
1359976|NCT01680497|Secondary|Investigator Assessment of Ease of Injection Use on a 10-Point Scale|Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).|Day 0, Day 14|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
1359977|NCT01680497|Secondary|Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale|Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
1359978|NCT01680497|Secondary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
1361330|NCT01665053|Secondary|Percentage of Participants With Myocardial Infarction at 12 Month.|The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.|12 months|Intent-to-treat|||percentage of participants|||Number
1359979|NCT01680497|Primary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
1359980|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.|||Participants|||Number
1359981|NCT01680458|Primary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.|||Participants|||Number
1359982|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.|||Participants|||Number
1359983|NCT01680458|Secondary|Onset Rate of Deep Mycosis|Efficacy of deep mycosis prophylaxis was evaluated by the presence or absence of deep mycosis onset during the observation period. Onset rate of deep mycosis was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Onset rate of deep mycosis (%) = (Number of participants with deep mycosis onset by target fungi) / (Number of participants available for prophylactic efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for prophylaxis comprised of participants in SAS who had started to receive fluconazole for the prophylaxis and had been evaluated for the presence or absence of deep mycosis onset.|||Percentage of participants||95% Confidence Interval|Number
1359984|NCT01680458|Secondary|Fungi Eradication Rate|Mycological effect of treatment was evaluated as follows: (1) eradicated; the causative fungi detected from the lesion before treatment became undetectable, (2) presumably eradicated; the lesion was improved and sampling of causative fungi became impossible, (3) decreased; the causative fungi were decreased, (4) unchanged; no change was observed in the causative fungi, (5) increased; the causative fungi were increased (including microbial substitution), and (6) indeterminate; the clinical follow-up was inadequate, causative fungi were undetectable, or mycological test was not performed. Fungi eradication rate was calculated as follows. Fungi eradication rate (%) = (Number of participants evaluated as “eradicated” or “presumably eradicated”) / (Number of participants available for mycological efficacy evaluation) x 100|MAX 13 Weeks|Mycological analysis set for treatment comprised of participants in SAS with the final diagnosis of deep mycosis, who had started to receive fluconazole for the treatment and had been evaluated for the mycological effect.|||Percentage of participants|||Number
1359985|NCT01680458|Secondary|Clinical Efficacy Rate|Clinical effect of treatment was evaluated based on the clinical course excluding mycological effect as follows: (1) effective, (2) ineffective, or (3) unevaluable. Clinical efficacy rate was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Clinical efficacy rate (%) = (Number of responders in evaluation of clinical effect) / (Number of participants available for clinical efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for treatment comprised of participants in safety analysis set (SAS) who had started to receive fluconazole for the treatment and had been evaluated for the clinical effect.|||Percentage of participants||95% Confidence Interval|Number
1359986|NCT01680341|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.|||episodes|||Number
1359987|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|From week 16 to end of trial including follow-up (week 27)|The safety analysis set included all subjects who received at least one dose of the investigational product. Subjects in maintenance period were included in this analysis.|||episodes|||Number
1359988|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.|||episodes|||Number
1360028|NCT01679314|Secondary|Change in Borg Dyspnoea Scores|Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8|Baseline vs 8 weeks|One subject in the Active AlphaCore device Group missing data at 8 weeks.|||Scores on a scale||Standard Deviation|Mean
1359989|NCT01680341|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0-28|The safety analysis set included all subjects who received at least one dose of the investigational product.|||number of events|||Number
1359990|NCT01680341|Secondary|Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia|Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Twenty five (25) subjects did not contribute to statistical analysis as Endpoint was only defined for subjects exposed for at least 12 treatment weeks.|||percentage of subjects|||Number
1359991|NCT01680341|Secondary|Subjects With HbA1c Below 7.0%|Number of subjects with HbA1c below 7% after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.|||Subjects|||Number
1359992|NCT01680341|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
1359993|NCT01680341|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).|||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
1359994|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.|||mcL||Standard Deviation|Mean
1359995|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.|||mcL||Standard Deviation|Mean
1359996|NCT01680328|Secondary|Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.|||scores|||Number
1359997|NCT01680328|Secondary|Acceptance of Injection Pain After Injection at Different Speeds.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.|||scores|||Number
1359998|NCT01680328|Secondary|Acceptance of Injection Pain After Injection of Different Volumes.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.|||scores|||Number
1359999|NCT01680328|Primary|Injection Pain (VAS mm)|Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. A total of 4 subjects did not contribute to the analysis due to missing injections (2) and missing VAS evaluation (2).|||mm||Standard Deviation|Mean
1360000|NCT01680172|Primary|Hospital Anxiety Depression Scale- Depression Score (HADS-D)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.|||units on a scale||Standard Deviation|Mean
1360001|NCT01680172|Primary|Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.|||units on a scale||Standard Deviation|Mean
1360002|NCT01680159|Secondary|Assessment of Severity (Only for Patients With Pustular Psoriasis)|From 0 (best) to 17 (worst)|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||units on a scale||Full Range|Mean
1360003|NCT01680159|Secondary|Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)|From 0 (best) to 100 (worst)|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||mm||Full Range|Median
1360074|NCT01678443|Secondary|Progression-free Survival||Up to 6 years|||||||
1360004|NCT01680159|Secondary|Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)|"The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.~0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe"|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||percentage of participants|||Number
1360005|NCT01680159|Secondary|Psoriasis Area and Severity Index (PASI) Score|Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||units on a scale||Full Range|Median
1360006|NCT01680159|Primary|Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score|"The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.~When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.~As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).~The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point."|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||percentage of participants|||Number
1360007|NCT01680016|Primary|Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|from V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
1360008|NCT01680016|Primary|Number of Children Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|From V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
1360009|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.|||Concentration (IU/ml)||95% Confidence Interval|Geometric Mean
1360010|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After First Vaccination in Children.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.|||Concentration (IU/mL)||95% Confidence Interval|Geometric Mean
1360011|NCT01680016|Primary|Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set|||Subjects|||Number
1360012|NCT01680016|Primary|Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
1360013|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
1360014|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
1360075|NCT01678443|Secondary|Overall Survival||Up to 6 years||||days||Full Range|Mean
1360076|NCT01678443|Secondary|Overall Response Rate||Up to 6 years|||||||
1360015|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
1360016|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
1360017|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years|Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|Analysis was done on the PP set.|||IU/mL||95% Confidence Interval|Geometric Mean
1360018|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||IU/mL||95% Confidence Interval|Geometric Mean
1360019|NCT01679613|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from time 0 to the last quantifiable nintedanib plasma concentration.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1360020|NCT01679613|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1360021|NCT01679613|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|The treated set (TS) includes all subjects who were dispensed study medication and were documented to have taken at least one dose of study medication (nintedanib or ketoconazole).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1360022|NCT01679600|Primary|Peak Oxygen Uptake (V'O2peak)||4 weeks||||mL/min||Standard Deviation|Mean
1360023|NCT01679314|Secondary|Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)|Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state|Baseline vs 8 weeks|One patient in the Active AlphaCore group missing data at 8 weeks.|||units on a scale||Standard Deviation|Mean
1360024|NCT01679314|Secondary|Number of Subjects With Adverse Events (AE)|"All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.~Brief description of the event (diagnosis)~Start date (and time, if relevant)~Stop date (and time, if relevant) (or resolution)~Severity~Action taken regarding the medical device~Opinion on causality~Seriousness~Outcome"|Throughout the course of the study (baseline to the 4 month follow-up visit)|All subjects reporting any Adverse Event|||participants|||Number
1360025|NCT01679314|Secondary|Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.~Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index"|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at 8 weeks.|||participants|||Number
1360026|NCT01679314|Secondary|Change in Forced Expiratory Volume (FEV1)|"Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation.~Change from baseline to week 8 between treatment groups"|Baseline vs 8 weeks|One subject in the Active AlphaCore group missing data at week 8|||Percentage of predicted value||Standard Deviation|Mean
1360027|NCT01679314|Secondary|Change 6 Minutes Walking Test|Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at week 8|||Meter||Standard Deviation|Mean
1362276|NCT01656850|Primary|Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||percentage of hemoglubin||Standard Deviation|Mean
1360029|NCT01679314|Primary|Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups|Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline.|8 weeks|One patient in the Active AlphaCore device Group missing data at 8 weeks.|||units on a scale||95% Confidence Interval|Least Squares Mean
1360030|NCT01679236|Secondary|Alcohol Use in Study Subjects vs Controls|Timeline follow back participant self-report of daily alcohol use.|2 weeks post quit day|||||||
1360031|NCT01679236|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day|2 weeks post quit day|total enrolled|||participants|||Number
1360032|NCT01679197|Secondary|Body Weight||1 year||||kg||Standard Deviation|Mean
1360033|NCT01679197|Secondary|Fasting Glucose||1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||mg/dL||Standard Deviation|Mean
1360034|NCT01679197|Secondary|Fasting Lipids|Cholesterol, triglycerides, HDL cholesterol, and LDL together make up the lipid profile and must be reported together. We are reporting the lipid profile where the treatment group arm would normally be listed, though, we are looking at the same single arm population of 23 participants who received treatment in this study.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||mg/dL||Standard Deviation|Mean
1360035|NCT01679197|Secondary|Liver Function Tests|AST and ALT are the liver function tests. We are reporting the liver function tests where the treatment group arm would normally be listed, though, we are looking at the same single arm population of 23 participants who received treatment in this study.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||IU/L||Standard Deviation|Mean
1360036|NCT01679197|Secondary|Liver Fat by MRI and MR Spectroscopy|All enrolled patients will have a baseline MRI of the liver to evaluate liver volume and liver fat. For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs’) fractional fat content throughout the liver in a few breath-hold intervals.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||%fat||Standard Deviation|Mean
1360037|NCT01679197|Primary|Liver Histopathology|Primary outcome will be the total non-alcoholic steatohepatitis (NASH) score read histopathologically from the liver biopsy samples. This outcome measure quantifies the severity of fatty liver disease. At baseline and at the end of the year, patients have undergone a transcutaneous liver biopsy and the specimens were graded for the severity of non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) pathology. Histological features of NAFLD/NASH were scored using the validated NASH-CRN (NASH Clinical Research Network) scoring system. This scoring system is the total of 4 subscales: steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2) and fibrosis (0-4), which are evaluated semi-quantitatively. The total scale range for this scoring system is 0-12, with 0 representing no features of fatty liver disease, and 12 representing the highest degree of fatty liver disease.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||units on a scale||Standard Deviation|Mean
1360038|NCT01679028|Primary|Incidence of Adverse Drug Events and Serious Adverse Events|the Incidence of Adverse Drug Events and serious adverse events|30 days (after first dosing)||||adverse event|||Number
1360039|NCT01679002|Secondary|Number of of Subjects Reporting at Least One Adverse Event|Number of of subjects reporting at least one adverse event.|8 weeks|The results are related to overall population in the study devided by period of treatment.|||Number of of subjects reporting at least|||Number
1360040|NCT01679002|Secondary|AUC - Area Under the Plasma Concentration Versus Time Curve|"AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:~BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.|||ng*h/mL||Standard Deviation|Mean
1360041|NCT01679002|Primary|Cmax - Maximum Observed Plasma Drug Concentration|"Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:~BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.|||ng/mL||Standard Deviation|Mean
1360042|NCT01678976|Other Pre-specified|Total of Subjects Reporting at Least One Adverse Event|Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient|4 weeks||||subjects reporting at least 1 AE|||Number
1360043|NCT01678976|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.|||ng*h/mL||Standard Deviation|Mean
1360044|NCT01678976|Primary|Maximum Drug Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.|||ng/mL||Standard Deviation|Mean
1360045|NCT01678911|Secondary|Patient Global Impression of Change|Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.|4 Visits over 15 weeks||||participants|||Number
1360046|NCT01678911|Secondary|Center for Epidemiologic Studies Depression Scale|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|4 visits over 15 week period||||units on a scale||Standard Deviation|Mean
1360047|NCT01678911|Secondary|Pain Disability Index|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|4 visits over an 8 week period||||units on a scale||Standard Deviation|Mean
1360048|NCT01678911|Secondary|Pain Anxiety Symptoms Scale|The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|4 Visits over an 8 week period||||units on the PASS scale||Standard Deviation|Mean
1360049|NCT01678911|Primary|McGill Pain Questionnaire - Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).|4 Visits over a 15 week period||||units on a scale||Standard Deviation|Mean
1360050|NCT01678885|Secondary|Device Predictions of % Weight Change During and After an 8-week LCD|This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI’s < 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis|8 weeks|Participants from sub-study 1 and 2 combined were used in this analysis.|||R squared|||Number
1360051|NCT01678885|Secondary|Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)|Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.|1 week|Of the 87 participants considered from phase 1 of sub-studies 1 and 2, five were excluded because they did not finish baseline accelerometry assessment, five were excluded because they did not enter the LCD due to BMI’s < 25. Seven were excluded because they did not successfully complete all aspects of the DLW dosing period.|||kcal/day||Standard Deviation|Mean
1360052|NCT01678885|Secondary|Weight Change|The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.|1 year|Weight change was evaluated from all participants who received the low calorie diet in sub-studies 1 and 2 combined.|||kg||Standard Deviation|Mean
1360053|NCT01678885|Primary|ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY|A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.|~6 days|Free-living energy intake data were analyzed from the 40 participants who completed the protocol and provided urine samples for doubly labeled water analysis. This primary outcome measure was limited to one sub-study.|||kCal||Standard Deviation|Mean
1360054|NCT01678846|Secondary|Safety and Well-being at School|"Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:~I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school."|At 2 year follow-up||||units on a scale||Standard Deviation|Mean
1360055|NCT01678846|Secondary|Educational Achievement: Word Recognition in English|Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).|2-year follow-up||||words per minute||Standard Deviation|Mean
1360056|NCT01678846|Secondary|Child Mental Health|score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).|2-year follow-up||||units on a scale||Standard Deviation|Mean
1360057|NCT01678846|Primary|Physical Violence From School Staff|past week experience of any physical violence from school staff|2-year follow-up||||participants|||Number
1360058|NCT01678820|Secondary|Percentage of Participants With A1C Level <7% at Week 16|Percentage of participants achieving glycemic goal (A1C <7%) after 16 weeks of treatment. Data as observed.|Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percentage of participants|||Number
1360059|NCT01678820|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
1360060|NCT01678820|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
1360061|NCT01678820|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Mean
1360062|NCT01678820|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
1360063|NCT01678820|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
1360064|NCT01678820|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
1360065|NCT01678820|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
1360066|NCT01678820|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||mg/dL||95% Confidence Interval|Least Squares Mean
1360067|NCT01678820|Secondary|Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent||95% Confidence Interval|Least Squares Mean
1360068|NCT01678820|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||Participants|||Number
1360069|NCT01678820|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||Participants|||Number
1360070|NCT01678820|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.|Baseline and Week 16|Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent||95% Confidence Interval|Least Squares Mean
1360071|NCT01678807|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment, up to 28 days|All randomized participants who receive at least one dose of study treatment|||Percentage of participants|||Number
1360072|NCT01678807|Primary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days|All randomized participants who receive at least one dose of study treatment|||Percentage of participants|||Number
1360073|NCT01678443|Secondary|Tumor to Normal Organ Ratios|Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.|Up to 6 years|||||||
1360077|NCT01678443|Primary|Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45|A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.|Up to 30 days after receiving study drug||||Participants|||Count of Participants
1360078|NCT01678313|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires|"Efficacy:~Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||units on a scale||Standard Deviation|Mean
1360079|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires|"Efficacy:~Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||units on a scale||Standard Deviation|Mean
1360080|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires|"Efficacy:~Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||units on a scale||Standard Deviation|Mean
1360081|NCT01678313|Secondary|Change From Baseline in the Maximum Flow Rate (Qmax)|"Efficacy:~Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||mL/s||Standard Deviation|Mean
1360082|NCT01678313|Secondary|Change From Baseline in the Void Volume (VV)|"Efficacy:~Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||mL||Standard Deviation|Mean
1360083|NCT01678313|Primary|Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level|"Efficacy:~Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||ng/mL||Standard Deviation|Mean
1360084|NCT01678196|Secondary|Caregiver Burden|Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).|3 months post-randomization|Sample sizes are smaller than total sample size due to missing questionnaire data.|||units on a scale||Standard Deviation|Mean
1360085|NCT01678196|Secondary|Family Functioning|Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.|3 months after the initiation of the intervention|Sample sizes are smaller than the overall sample due to missing questionnaire data.|||units on a scale||Standard Deviation|Mean
1360086|NCT01678196|Secondary|Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18|Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).|3 months after initiation of the intervention|Group sample sizes are smaller than total sample sizes due to missing data.|||units on a scale||Standard Deviation|Mean
1360087|NCT01678196|Primary|Veteran Engagement in VA Mental Health Services|Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.|3 months after initiation of the intervention||||participants|||Number
1360088|NCT01678131|Primary|Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA|Liver samples were collected by FNA at 3 of 5 of the following specified postdose timepoints: 3, 12, 24, 48 and 72 hours after a single vaniprevir dose on Day 7. The technical success of the FNA procedure was established for a participant if vaniprevir was detected from at least 2 of the 3 FNA collection timepoints.|Day 7 up to Day 10 at 3 of the following timepoints: 3, 12, 24, 48 and 72 hours postdose|Participants treated with vaniprevir who had hepatic FNA collected at 3 timepoints. One participant from the 300 mg Vaniprevir + Peg-IFN/RBV treatment group, and one participant from the 600 mg Vaniprevir + Peg-IFN/RBV treatment group discontinued treatment prior to collection of 3 FNAs, and were therefore excluded from the analysis.|||Participants|||Number
1360089|NCT01677988|Other Pre-specified|CTC Expression|To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient.|2 years|The CTC expression endpoint was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.||||||
1360090|NCT01677988|Other Pre-specified|CTC Analysis|To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma.|End of study|The CTC analysis was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.||||||
1360091|NCT01677988|Other Pre-specified|Feasibility Objective|The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population.|From enrollment to end of chemotherapy part of the study|The number of subjects who had 5-6 doses of neoadjuvant regimen|||participants|||Number
1360092|NCT01677988|Secondary|Overall Survival:|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|The study terminated early, prior to the end of the follow up period for all subjects. At the time of study termination, one subject had expired and the time from enrollment to death for that subject is reported below.|||days|||Number
1360093|NCT01677988|Secondary|Time to Recurrence:|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|The study terminated early, prior to the follow up period being completed. Only one subject had surgery and that subject is still alive at the time of study termination, so time to recurrence cannot be estimated.||||||
1360094|NCT01677988|Secondary|Histopathologic Tumor Response|Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.|at the time of surgery|Only subjects who had surgery were included in this outcome measure.|||grade II responder|||Number
1360095|NCT01677988|Secondary|Radiographic Tumor Response|The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.|From enrollment to Surgery|All subjects enrolled and had a response assessment are included in the outcome measure below.|||participants|||Number
1360096|NCT01677988|Primary|Estimate the R0/R1 Resection Rate|Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.|at time of surgery|Only subjects who had surgery were included in the outcome measure data.|||participants|||Number
1360097|NCT01677936|Secondary|Systolic Blood Pressure|Raisins versus snacks: mmHg change in systolic blood pressure at week 12|12 weeks.||||mmHg||Standard Deviation|Mean
1360098|NCT01677936|Primary|Postprandial Glucose Levels|Raisins versus snacks: percent change in postprandial glucose levels at week 12|12 weeks||||percent||Standard Deviation|Mean
1360099|NCT01677910|Primary|Number of Participants With TEAEs in the Open-Label Extension Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)|Safety population, defined as all subjects who received at least one dose of study drug was used for analysis.|||Participants|||Count of Participants
1360100|NCT01677910|Secondary|Change From Baseline in Abdominal Pain Averaged Across All Time-Points|Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with available data were included in the analyses.|||units on a scale||Standard Deviation|Mean
1360101|NCT01677910|Secondary|Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points|Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses.|||counts/day||Standard Deviation|Mean
1360102|NCT01677910|Secondary|Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels|u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants, with u5-HIAA data available at Baseline and Week 12 were included in the analyses.|||mg/24 hours||Standard Deviation|Mean
1360103|NCT01677910|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)|Safety population, defined as all subjects who received at least one dose of study drug was used for analysis.|||Participants|||Count of Participants
1360104|NCT01677910|Primary|Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks|Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses.|||counts/day||Standard Deviation|Mean
1360105|NCT01677858|Secondary|Mean Residence Time Observed From Time Zero to Infinity (MRT0-∞) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hours||Geometric Coefficient of Variation|Geometric Mean
1360106|NCT01677858|Secondary|Clearance of Carfilzomib After IV Infusion||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
1360107|NCT01677858|Secondary|Terminal Half-life (T1/2,z) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hours||Geometric Coefficient of Variation|Geometric Mean
1360108|NCT01677858|Secondary|Volume of Distribution Observed at Steady State (Vss) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||liters||Geometric Coefficient of Variation|Geometric Mean
1360109|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve During the Dosing Interval (0-168 Hours) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1360110|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) fo Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1360111|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1360112|NCT01677858|Secondary|Maximum Plasma Concentration of Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1360113|NCT01677858|Secondary|Time to Maximum Plasma Concentration of Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hours||Full Range|Median
1360114|NCT01677858|Secondary|Number of Participants With Adverse Events|Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).|From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||Participants|||Count of Participants
1360115|NCT01677858|Secondary|Duration of Response|Duration of response (DOR) was defined as the time from first evidence of PR or better to disease progression or death due to any cause. DOR was calculated using Kaplan-Meier methods; Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.|From randomization until the data cut-off date of 22 July 2016; median follow-up time for DOR was 14.3 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone) with a best overall response of sCR, CR, VGPR, or PR.|||months||95% Confidence Interval|Median
1360116|NCT01677858|Secondary|Time To Progression|Time to progression (TTP) was defined as the time from first dose to disease progression evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). TTP was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.|From randomization until the data cut-off date of 22 July 2016; median follow-up time for TTP was 13.4 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||months||95% Confidence Interval|Median
1360127|NCT01677767|Primary|Percentage of Participants Achieved Target Range of Hemoglobin|The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time – visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.|||Percentage of participants|||Number
1379754|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|2.5 weeks (or after treatment session 5)|||||||
1360117|NCT01677858|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from first dose to the earlier of disease progression or death due to any cause. The duration of PFS was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.~Participants were evaluated for disease response and progression by the investigator according to the IMWG-URC."|From randomization until the data cut-off date of 22 July 2016; median follow-up time for PFS was 13.8 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||months||95% Confidence Interval|Median
1360118|NCT01677858|Secondary|Clinical Benefit Response Rate|Clinical benefit rate was defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a 25% to 49% reduction in the level of serum M-protein or a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour, maintained for a minimum of 8 weeks.|Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||percentage of participants||95% Confidence Interval|Number
1360119|NCT01677858|Primary|Overall Response Rate (ORR)|"Disease response was evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM.~VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||percentage of participants||95% Confidence Interval|Number
1360120|NCT01677858|Primary|Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)|"The MTD was defined as the highest carfilzomib dose at which < 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows:~Nonhematologic:~≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting < 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment)~≥ grade 3 acute kidney injury (creatinine > 3 x baseline or > 4.0 mg/dL) lasting > 72 hours~≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy~Hematologic:~grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) for > 7 days~febrile neutropenia (ANC < 1000/mm³ with a fever ≥ 38.3ºC) of any duration~grade 4 thrombocytopenia (< 25 000/mm³) for > 14 days, despite holding treatment~grade 3 or 4 thrombocytopenia (< lower limit of normal) associated with > grade 1 bleeding"|28 days|Participants in phase 1 who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||participants|||Number
1360121|NCT01677767|Primary|Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.|Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.|||Percentage of participants|||Number
1360122|NCT01677767|Secondary|Number of Participants Received Concomitant Medications|Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.|Up to Week 24|The safety population included all participants enrolled into the study|||Number of participants|||Number
1360123|NCT01677767|Secondary|Evaluation of Dose Per Injection of C.E.R.A|The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.|Up to Week 24|The safety population included all participants enrolled into the study|||Microgram||Standard Deviation|Mean
1360124|NCT01677767|Secondary|Evaluation of Route of Administration for C.E.R.A|C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.|Up to Week 24|The safety population included all participants enrolled into the study|||Number of injections|||Number
1360125|NCT01677767|Secondary|Mean Time Spent by Participants in the Hb Target Range|Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.|Up to Week 24|ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.|||Week||Standard Deviation|Mean
1360126|NCT01677767|Secondary|Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study|For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.|||Number of participants|||Number
1360128|NCT01677767|Primary|Mean Time Required to Achieve Target Hemoglobin Range|The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time – visit date of first dosing) + 1|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.|||Week||Standard Deviation|Mean
1360129|NCT01677767|Primary|Number of Participants With Co-morbidity Treated With C.E.R.A|Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.|Up to Week 24|The safety population included all participants enrolled into the study.|||Number of participants|||Number
1360130|NCT01677767|Primary|Mean Weight of Participants Treated With C.E.R.A|Weight of the participants was measured at the Baseline and summarized with descriptive statistics.|Baseline (Week 0)|The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.|||Kilograms||Standard Deviation|Mean
1360131|NCT01677767|Primary|Mean Age of Participants Treated With C.E.R.A|Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date – Date of birth)/365.25|Baseline (Week 0)|The safety population included all participants enrolled into the study.|||Years||Standard Deviation|Mean
1360132|NCT01677624|Secondary|Success Rate for Operability of Embolization|Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.|||percentage of participants||95% Confidence Interval|Number
1360133|NCT01677624|Primary|Success Rate of Embolization in the Target Vessel|Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.|||Percentage of participants||95% Confidence Interval|Number
1360134|NCT01677507|Secondary|Variation in Episcleral Venous Pressure.|Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.|1 week treatment|These measures can be difficult to obtain, so sometimes participants do not tolerate it and some values are missing.|||mmHg||Standard Deviation|Mean
1360135|NCT01677507|Secondary|Variation in Aqueous Flow Between Individuals.|Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.|1 week after treatment|These measurements can be difficult for participants to tolerate, so sometimes values are missing.|||microliters/min||Standard Deviation|Mean
1360136|NCT01677507|Primary|Variation in Eye Pressure Between Individuals.|Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.|Measurement after 1 week of drug treatment||||mmHg||Standard Deviation|Mean
1360137|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of PYY||Ratio of Day 5 to Baseline|Evaluable Population|||none (values are ratios)||Standard Error|Least Squares Mean
1360138|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of GLP-1||Ratio of Day 5 to Baseline|Evaluable|||none (values are ratios)||Standard Error|Least Squares Mean
1360139|NCT01677299|Primary|Change in Fasting Plasma Glucose|LS mean difference from Baseline (Day 1) to Day 5|Change from Baseline (Day 1) to Day 5|Evaluable Population|||mg/dL||Standard Error|Least Squares Mean
1360140|NCT01677299|Primary|Area Under the Curve (0-t) of Plasma Metformin|Measures from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration. The dose of study medication was administered at t = -1 min relative to the start time of the standardized breakfast.|Time points at which data were collected to create the area under the curve (0-t) for plasma metformin were: t = -0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 11 h relative to the start time of the standardized breakfast.|Evaluable Population|||ng*h/mL||Standard Deviation|Mean
1360141|NCT01677286|Primary|Amyloid Nephropathy: Proteinuria|Patients with predominant amyloid kidney involvement at enrollment.|Data were assessed at baseline, 6 and 12 months, with change at end of study reported|Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all data collected at baseline, 6 and 12 months.|||g/day||Standard Deviation|Mean
1360142|NCT01677286|Primary|Amyloid Nephropathy: Creatinine Clearance|Creatinine clearance (ml/min) and proteinuria (g/day) were assessed at baseline, 6 and 12 months, with change at change at end of study reported|12 months|Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all collected data.|||ml/min||Standard Deviation|Mean
1360143|NCT01677286|Primary|Amyloid Cardiomyopathy: Troponin I|Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at change at end of study reported|12 months|Patients with predominant amyloid involvement of the heart.|||ng/mL||Standard Deviation|Mean
1360144|NCT01677286|Primary|Amyloid Cardiomyopathy: BNP|Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at end of study reported|12 months|Analysis is limited to the patients with predominant amyloid heart involvement at enrollment. Mixed models analyses of change from baseline levels of cardiac biomarkers (BNP, Troponin I) were performed to include all collected data.|||pg/mL||Standard Deviation|Mean
1360145|NCT01677195|Primary|AFB1-lysine Adduct (pg/mg) Overtime|After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.|3 months on intervention (weeks 0-12); 1 month off intervention (week 16)||||pg/mg albumin||Standard Deviation|Mean
1360146|NCT01677182|Secondary|Percentage of Participants With MADRS Remission|MADRS remission is defined as a MADRS total score less than or equal to (<=) 10. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. LOCF method was used to impute missing data.|||percentage of participants|||Number
1360147|NCT01677182|Secondary|Percentage of Participants With MADRS Response|MADRS response is defined as greater than or equal to (>=) 50 percent (%) decrease in the MADRS total score from baseline. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants|||Number
1360148|NCT01677182|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 6|Q-LES-Q-SF is a self-administered, widely used 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are 2 global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of the total possible score, with higher scores indicating better health status.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||percentage of total possible score||Standard Error|Least Squares Mean
1360149|NCT01677182|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS is a 3-item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over 3 inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11-point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30 where higher scores indicates greater severity of impairment.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
1360150|NCT01677182|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
1360151|NCT01677182|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) to Week 6|"The CGI-S assesses the clinician’s impression of the participant’s current state of mental illness and consists of 1 question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill)."|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
1360152|NCT01677182|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score|The CGI-I assesses the clinician’s impression of the participant’s state of mental illness improvement and consists of 1 question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). In all cases, the assessment was independent of whether the rater believed the improvement was drug-related or not.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
1360153|NCT01677182|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS is a 11-item scale to assess manic symptoms. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), and 7 items are rated on a scale from 0 to 4 with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
1360154|NCT01677182|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6|The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0(normal) to 6(most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on scale||Standard Error|Least Squares Mean
1360155|NCT01676961|Secondary|Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis||Up to 1.5 years|Patient data was not analyzefd||||||
1360156|NCT01676961|Primary|Percentage of Patients Who Have Responded|Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.|8 weeks|Data was not analyzed. Dr. Mazumder left institution and data was not analyzed.||||||
1360157|NCT01676896|Other Pre-specified|Lung Inflammation, Time 3|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.|Time 3 at 9 months||||uM||Standard Deviation|Mean
1360158|NCT01676896|Other Pre-specified|Lung Inflammation, Time 2|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.|Time 2 at 5 months||||uM||Standard Deviation|Mean
1360159|NCT01676896|Other Pre-specified|Lung Inflammation, Time 1|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.|Time 1 at baseline||||uM||Standard Deviation|Mean
1360160|NCT01676896|Secondary|Medication Adherence, Time 3|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 3 visit.|Time 3 at 9 months||||number of yes responses||Standard Deviation|Mean
1360161|NCT01676896|Secondary|Medication Adherence, Time 2|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 2 visit.|Time 2 at 5 months||||number of yes responses||Standard Deviation|Mean
1360162|NCT01676896|Secondary|Medication Adherence, Time 1|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at study enrollment, Time 1.|Time 1 at baseline||||number of yes responses||Standard Deviation|Mean
1360163|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 1|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at enrollment visit, Time 1 data visit.|Time 1 at baseline||||number of correct steps||Standard Deviation|Mean
1360164|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 2|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 2 data visit.|Time 2 at 5 months||||number of correct steps||Standard Deviation|Mean
1360165|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 3|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at time 3 data visit.|Time 3 at 9 months||||number of correct steps||Standard Deviation|Mean
1360166|NCT01676896|Secondary|Home Asthma Management, Time 3|Parent report of asthma preventive and treatment activities. Data collected at third time point (Time 3). Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 3 at 9 months||||units on a scale||Standard Deviation|Mean
1360167|NCT01676896|Secondary|Home Asthma Management, Time 2.|Parent report of asthma preventive and treatment activities. Data collected at the time 2 visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 2 at 5 months||||units on a scale||Standard Deviation|Mean
1360168|NCT01676896|Secondary|Home Asthma Management, Time 1, Baseline|Parent report of asthma preventive and treatment activities. Data are collected at study enrollment, Time 1, baseline visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 1, baseline||||units on a scale||Standard Deviation|Mean
1360169|NCT01676896|Secondary|Asthma Self-management, Time 1, Baseline|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the baseline, Time 1 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 1, baseline||||units on a scale||Standard Deviation|Mean
1360170|NCT01676896|Secondary|Asthma Self-management, Time 2|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 2 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 2 at 5 months||||units on a scale||Standard Deviation|Mean
1361637|NCT01663012|Secondary|Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death|Will be described using Kaplan-Meier estimates.|From date of first dose of NKTR-102 to date of death, assessed up to 2 years||||Months||95% Confidence Interval|Median
1360171|NCT01676896|Secondary|Asthma Self-management, Time 3|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 3 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 3 at 9 months||||units on a scale||Standard Deviation|Mean
1360172|NCT01676896|Primary|Quality of Life, Pre-study Year|Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months before baseline||||units on a scale||Standard Deviation|Mean
1360173|NCT01676896|Primary|Emergency Department Visits, Pre-study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline||||number of visits||Standard Deviation|Mean
1360174|NCT01676896|Primary|Number of Asthma Hospital Stays, During Study Year|Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.|12 months||||number of hospital stays||Standard Deviation|Mean
1360175|NCT01676896|Primary|Number of Days in Hospital for Asthma, Pre-Study Year|Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline||||days hospitalized||Standard Deviation|Mean
1360176|NCT01676896|Primary|Absenteeism Pre-study Year|(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.|12 months before baseline|Data for days enrolled and days absent for the pre-study year was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.|||percentage of days enrolled||Standard Deviation|Mean
1360177|NCT01676896|Primary|Number of Asthma Hospitalizations Pre-Study Year|Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline||||number of hospitalizations||Standard Deviation|Mean
1360178|NCT01676896|Other Pre-specified|Lung Inflammation, Time 4|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.|Time 4 at 12 months||||uM||Standard Deviation|Mean
1360179|NCT01676896|Secondary|Medication Adherence, Time 4|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at final data point, Time 4.|Time 4 at 12 months||||number of yes responses||Standard Deviation|Mean
1360180|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 4|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 4 data visit.|Time 4 at 12 months||||number of correct steps||Standard Deviation|Mean
1360181|NCT01676896|Secondary|Home Asthma Management, Time 4, End of Study|Parent report of asthma preventive and treatment activities. Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 4 at 12 months||||units on a scale||Standard Deviation|Mean
1360182|NCT01676896|Secondary|Asthma Self-management, Time 4|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 4, final measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 4, at 12 months||||units on a scale||Standard Deviation|Mean
1360183|NCT01676896|Primary|Emergency Department Visits, Study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.|12 months||||number of visits||Standard Deviation|Mean
1360184|NCT01676896|Primary|Number of Days Hospitalized, During Study Year|Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.|12 months||||days hospitalized||Standard Deviation|Mean
1360185|NCT01676896|Primary|Quality of Life, End of Study|Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months||||units on a scale||Standard Deviation|Mean
1360186|NCT01676896|Primary|Absenteeism, End of Study|(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.|12 months|Data for days enrolled and days absent was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.|||percentage of days enrolled||Standard Deviation|Mean
1360187|NCT01676727|Secondary|Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)-Combined Safety Endpoint|"The combined safety endpoint is defined as a composite of:~All-cause mortality~All stroke~Life-threatening bleeding~Acute kidney injury-Stage 3 (including renal replacement therapy)~Coronary artery obstruction requiring intervention~Major vascular complication~Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)~High degree AV block requiring permanent pacemaker implantation"|1, 6 and 12 months|all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach|||Percentage of subjects, Kaplan-Meier||95% Confidence Interval|Number
1360188|NCT01676727|Primary|All-cause Mortality|30-day all-cause mortality Kaplan-Meier rate.|30 days post-implant|all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach|||Percentage of subjects, Kaplan-Meier||95% Confidence Interval|Number
1360189|NCT01676714|Secondary|Number of Patients Who Experienced Treatment Related Toxicities|Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.|Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.||||Participants|||Count of Participants
1360190|NCT01676714|Secondary|Progression Free Survival|The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment until the date of death from any cause, assessed up to 100 months||||months||Full Range|Median
1360191|NCT01676714|Secondary|Disease Control Rate|The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.|From start of treatment, up to 8 weeks|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until progression or unacceptable toxicity develops.|||participants|||Number
1360192|NCT01676714|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 100 months||||Participants|||Count of Participants
1360193|NCT01676701|Secondary|Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)||Baseline, Weeks 4 and 8|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360194|NCT01676701|Secondary|Number of Operation Failures||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360195|NCT01676701|Secondary|Number of Participants Developing Anti-Tabalumab Antibodies||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360196|NCT01676701|Secondary|Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360197|NCT01676701|Secondary|Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level||Baseline, Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360198|NCT01676701|Secondary|Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index||Baseline, Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360199|NCT01676701|Secondary|Percentage of Participants Achieving ACR Response||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360200|NCT01676701|Secondary|Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set||Baseline, Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360201|NCT01676701|Primary|PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]||Days 4, 7, 9, 11, and 14 after loading dose administered|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360202|NCT01676701|Primary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose||Days 4, 7, 9, 11, and 14 after loading dose administered|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
1360203|NCT01676532|Other Pre-specified|Ontario Health Insurance Plan (OHIP)Status|OHIP status of students attending the clinic was not reported or collected|1 year|||||||
1360204|NCT01676532|Other Pre-specified|Absenteeism|Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected|1 year|||||||
1360205|NCT01676532|Other Pre-specified|Follow-up Appointments|Attendance at follow-up appoints was not collected.|1 year|||||||
1360206|NCT01676532|Other Pre-specified|Number of Students Referred to SBHC Who Attended SBHC|This data was not collected.|8 months|||||||
1360207|NCT01676532|Other Pre-specified|Number of Students Triaged From School Support Team Meetings|The number of students triaged from SST meetings was not collected.|1 year|||||||
1360208|NCT01676532|Other Pre-specified|Sprucecourt Public School Vs Other Participating Schools|To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools|8 months|total number of students who attended SBHC|||participants|||Number
1360209|NCT01676532|Other Pre-specified|Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)|The number of students who enrolled in SBHC who were from the host school Sprucecourt|8 months|Total number of students who enrolled in SBHC. Outcome is the number of students from host school (sprucecourt) who enrolled in SBHC|||participants|||Number
1360210|NCT01676532|Secondary|Number of Referrals Made of Students Attending SBHC|Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic|1 year||||participants|||Number
1360211|NCT01676532|Secondary|Number of Students Attending SBHC With New Diagnoses|Number of students attending SBHC with new diagnoses|1 year|120 of the 127 students who attended the SBHC had a new diagnosis. 94 received one new diagnosis and 26 children received more than one new diagnosis|||participants|||Number
1360212|NCT01676532|Secondary|Number of Students Attending SBHC With New Treatment Plans|Proportion of children seen in the clinic with treatment plans|1 year|115 students out of 127 students attending SBHC had a new treatment plan.|||participants|||Number
1360213|NCT01676532|Primary|Number of Enrolled Participants Who Attended SBHC|"The primary objectives are to determine utilization of the SBHC including:~The number of students who are enrolled at the SBHC~The number of enrolled students enrolled who attended the SBHC"|1 year|379 students enrolled in the SBHC and 127 of those students attended SBHC. Existing data is based on 127 students who attended SBHC.|||participants|||Number
1360214|NCT01676415|Secondary|Medication Side-effect and Compliance Inventory|The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.|4-6 weeks and 3 months after initiation of treatment|Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.|||Participants|||Count of Participants
1360215|NCT01676415|Secondary|Taskforce Symptom Inventory|Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.|4-6 weeks and 3 months after initiation of treatment|Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.|||Participants|||Count of Participants
1360216|NCT01676415|Secondary|Lund-McKay Score From CT Scan|Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.|4-6 weeks and 3 months after initiation of treatment|Only a few of the patients were able to return for the follow up CT scan, therefore this measure was not analyzed.||||||
1360217|NCT01676415|Primary|SNOT-22 Questionnaire|"The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (“nasal obstruction” and “loss of smell and taste”) ranked from 0 (not a problem) to 5 (problem as bad as it can be).~Min score= 0, Max score= 110 (worst possible problem on all symptoms)~Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis."|4-6 weeks and 3 months after initiation of treatment||||units on a scale||Standard Error|Mean
1360218|NCT01676298|Primary|Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.|"Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.~All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is Inconclusive for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement)."|After second pass result is complete (~3h)||||Percentage of Correct Calls|Participants|95% Confidence Interval|Number
1360219|NCT01676220|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to 12 months|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
1360220|NCT01676220|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).|||units on a scale||Standard Error|Least Squares Mean
1360221|NCT01676220|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6|Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal insulin dose assessment.|||U/kg||Standard Deviation|Mean
1360222|NCT01676220|Secondary|Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint|Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).|||percentage of mean||Standard Error|Least Squares Mean
1360369|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360223|NCT01676220|Secondary|Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint|Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).|||mmol/L||Standard Error|Least Squares Mean
1360224|NCT01676220|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).|||mmol/L||Standard Deviation|Mean
1360225|NCT01676220|Secondary|Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).|||percentage of participants|||Number
1360226|NCT01676220|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).|||mmol/L||Standard Error|Least Squares Mean
1360227|NCT01676220|Secondary|Percentage of Participants With HbA1c <7% at Month 6|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).|||percentage of participants|||Number
1360228|NCT01676220|Secondary|Variability of Preinjection SMPG at Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Month 6|mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).|||percentage of mean||Standard Error|Least Squares Mean
1360229|NCT01676220|Secondary|Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)|||mmol/L||Standard Error|Least Squares Mean
1360230|NCT01676220|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.|Week 9 Up to Month 6|Modified intent-to-treat population.|||percentage of participants|||Number
1360231|NCT01676220|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).|||percentage of hemoglobin||Standard Error|Least Squares Mean
1360232|NCT01676116|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).|Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0–6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range.|Week 0, week 26|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Scores on a scale||Standard Deviation|Mean
1360372|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360233|NCT01676116|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure – Diabetes (TRIM-D)|The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1–5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0–100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here.|Week 0, week 26|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Scores on a scale||Standard Deviation|Mean
1360234|NCT01676116|Secondary|Number of Adverse Events (AEs)|Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment.|After 26 weeks of treatment|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis.|||events per 100 exposure years|||Number
1360235|NCT01676116|Secondary|Number of Severe or Minor Hypoglycaemic Episodes|Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or PG <3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or PG value <3.1 mmol/L (56 mg/dL).|After 26 weeks of treatment|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis.|||events per 100 patient years of exposure|||Number
1360236|NCT01676116|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.|Week 0, week 26|Full analysis set included all randomised subjects. A total of 430 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||mmol/L||Standard Deviation|Mean
1360237|NCT01676116|Secondary|Change From Baseline in Body Weight|Mean change in body weight after 26 weeks of treatment.|Week 0, week 26|Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||kg||Standard Deviation|Mean
1360238|NCT01676116|Secondary|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol).|Week 26|Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Percentage|||Number
1360239|NCT01676116|Secondary|Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)|Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.|Week 26|Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Percentage|||Number
1360240|NCT01676116|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)||Week 0, week 26|Full analysis set included all the randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1360241|NCT01676012|Secondary|Sensitivity and Specificity of HD Videobronchoscopy|When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.|one year|||||||
1360242|NCT01676012|Primary|Sensitivity|Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.|one year|Vascular abnormalities were scored most frequently in HD + i-scan2 bronchoscopy. Sites suspicious for preinvasive lesions were most frequently reported using AFB. Tumors were detected equally by all modalities. The preferred modality was HD bronchoscopy with i-scan.|||# vascular sites detected per patient||Standard Error|Mean
1360243|NCT01675830|Secondary|Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use|To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.|These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.|Number of adverse events observed|||adverse events|||Number
1360244|NCT01675830|Primary|Head Wrap Feasibility|To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.|<12 hours|Percentage of respondents that agree device is easy to use|||percentage of respondents|||Number
1360245|NCT01675661|Primary|The Odds of Negative Urine Cannabinoid Tests During Treatment.|The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.|study weeks 2-13|Intent to treat; all participants randomized|||cannabis negative urine tests|||Number
1360246|NCT01675635|Secondary|Comparison of the Total Amount of Study Drugs Used During the 24 Hours|"To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison~The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose."|24 hours after administration of first dose|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||mg||Standard Deviation|Mean
1360247|NCT01675635|Secondary|Satisfaction With Pain Control|"To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison~Very Satisfied~Satisfied~Fair~Not Satisfied~Not Satisfied at all"|24 hours after administration of first dose|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||Participants|||Count of Participants
1360248|NCT01675635|Secondary|Sleeping Quality Assessment|"To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison~Sleeping quality scale~Very Good~Good~Fair~Bad~Very Bad"|24 hours after administration of first dose|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||Participants|||Count of Participants
1360249|NCT01675635|Secondary|VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)|"To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison~Visual Analogue Scale~0 10 20 30 40 50 60 70 80 90 100~0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage"|Baseline and 6h (±20min)|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||units on a scale||Standard Deviation|Mean
1360250|NCT01675635|Secondary|The Use of Rescue Analgesics During the 24-hour Observation Period|To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison|24 hours after the first dose.|in FAS population|||Participants|||Count of Participants
1360251|NCT01675635|Secondary|VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose|To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison|Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)||||units on a scale||Standard Deviation|Mean
1360252|NCT01675635|Primary|Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)|"To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison~Visual Analogue Scale~0 10 20 30 40 50 60 70 80 90 100~0 means no pain; 100 means pain as bad as you can image at resting stage"|Baseline and 6h (±20min)|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||units on a scale||Standard Deviation|Mean
1360253|NCT01675622|Secondary|Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment|For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).|baseline up to 19-22 days (open label treatment)||||percentage of pain relief||Standard Deviation|Mean
1360254|NCT01675622|Secondary|Degree of Pain Relief Within 24hrs After Treatment|Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).|baseline up to 5-8 days (double blind period)||||percentage of pain relief||Standard Deviation|Mean
1360255|NCT01675622|Secondary|the Total Dose of Rescue Medicine for Breakthrough Pain.|the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups|baseline up to 22 days (double blind period)|The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose.|||mg||Standard Deviation|Mean
1360256|NCT01675622|Secondary|Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment|The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.|baseline up to 19-22 days (open label treatment)||||scores on a scale||Standard Deviation|Mean
1360257|NCT01675622|Secondary|Average Number of Titrations|the average times to change the dose in order to find the proper dose between two treatment groups|baseline up to 1-3 days(double blind period)|Dosing change frequency for complete titration|||dose changes||Standard Deviation|Mean
1360258|NCT01675622|Secondary|Patient Assessments of Satisfaction for Pain Management|the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.|baseline up to 19-22 days (open label treatment)||||Participants|||Count of Participants
1360259|NCT01675622|Secondary|Times of Breakthrough Pain Occurrence|the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups|Within 8 days after baseline||||breakthrough pain events|||Number
1360260|NCT01675622|Secondary|Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period|The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.|baseline up to 5-8 days (double blind period)||||scores on a scale||Standard Deviation|Mean
1360261|NCT01675622|Secondary|The Average Dose of Study Medicine Used During Double Blind Treatment Period|the average dose of study medicine used during double blind treatment period between the two treatment groups.|baseline up to 5-8 days (double blind period)|The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics.|||mg||Standard Deviation|Mean
1360262|NCT01675622|Primary|Numerical Rating Scale (NRS)|The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.|baseline up to 5-8 days (double blind period)||||scores on a scale||Standard Deviation|Mean
1360263|NCT01675544|Primary|Mortality|All cause mortality at 1 year|1 year||||participants|||Number
1360264|NCT01675544|Primary|Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)||1 year||||participants|||Number
1360265|NCT01675531|Secondary|Patient's Overall Satisfaction|Patient's overall satisfaction was assessed 7 scales from very much worse to very much improved. (Very much worse, much worse, minimally worse, no change, minimally improved, much improved, very much improved)|4weeks|Analysis of ITT population set.|||participants|||Number
1360266|NCT01675531|Secondary|Physician's Overall Satisfaction|Physician's overall satisfaction was scored 7 scales from Very much worse to Very much improved. (Very much worse, much worse, minimally worse, No change, Minimally improved, much improved, very much improved).|4 weeks|Analysis of ITT population set.|||participants|||Number
1360267|NCT01675531|Secondary|Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).|"Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FAICT-GOG/NTX).~The mean changes in FACT/GOG-NTX total score and each FACT/GOG-NTX subscale score from Visit 1 (Week 0) to Visit 4 (Week 4 post-treatment) were analyzed. Missing data was handled as LOCF(Last Observation Carried Forward Method).~FACT/GOG-NTX total score range was from 0 to 152. The average change score from baseline to visit 4 indicates thay a lower score on the FACT/GOG-NTX means lower quality of life and a greater impact of neurotoxic symptom on the patient’s life."|4 weeks|Analysis of ITT population set.|||units on a scale||Standard Deviation|Mean
1360268|NCT01675531|Primary|NRS (Numeric Rating Scale)|"Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0).~NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline."|4 weeks|Analysis of ITT population set. Missing data was handled as LOCF(Last Observation Carried Forward Method).|||units on a scale||Standard Deviation|Mean
1360269|NCT01675492|Secondary|Uncorrected Visual Acuity (UCVA) of 20/40 or Better|85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters|3 Months||||eyes|eyes||Count of Units
1360270|NCT01675492|Primary|Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)|< 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters|3 Months||||eyes|eyes||Count of Units
1360271|NCT01675479|Secondary|Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better|Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters|12 Months||||eyes|eyes||Count of Units
1360272|NCT01675479|Primary|Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)|Hypothesis: <5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters|12 Months||||eyes|eyes||Count of Units
1360273|NCT01675453|Secondary|Chloride Loading|The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay|24 h|||||||
1360274|NCT01675453|Secondary|Duration of Mechanical Ventilation||24 hours|||||||
1360275|NCT01675453|Secondary|Blood Loss|Bleeding from chest tubes|24 hours|||||||
1360276|NCT01675453|Secondary|Rate of Neurological Complications|Delirium, clinically diagnosed stroke, and encephalopathy.|24 hours|||||||
1360277|NCT01675453|Secondary|Stroke Volume Index||24 hours|||||||
1360278|NCT01675453|Secondary|Rate of Hyperchloremic Metabolic Acidosis|blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.|24 hours|||||||
1360279|NCT01675453|Secondary|Rate of Acute Kidney Injury|serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.|48 hours|||||||
1360280|NCT01675453|Secondary|Plasma Osmolarity||24 hours|||||||
1360281|NCT01675453|Secondary|Plasma Na||24 hours|||||||
1360282|NCT01675453|Secondary|Endothelial Integrity|Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.|24 hours|||||||
1360283|NCT01675453|Secondary|Inflammation Response|Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.|24 hours|||||||
1360284|NCT01675453|Secondary|Fluid Balance|Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.|24 hours|||||||
1360285|NCT01675453|Secondary|Cardiac Index||24 hours|||||||
1360286|NCT01675453|Secondary|Oxygen Delivery|Oxygen delivery index (DO2I) will be used to assess this outcome measure.|24 hours|||||||
1360287|NCT01675453|Secondary|Pulmonary Oxygenation|Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.|24 hours|||||||
1360370|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360288|NCT01675453|Primary|Extravascular Lung Water Index|Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to “Predicted Body Weight”.|baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1||||mL/kg||Inter-Quartile Range|Median
1360289|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360290|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360291|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 g/dL or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360292|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 grams per deciliter (g/dL) or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360293|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included SVR, relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360294|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included sustained virological response (SVR), relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360295|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360296|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360371|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360297|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included RVR, cEVR, and pEVR. RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360298|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included rapid virological response (RVR), complete early virological response (cEVR), and partial early virological response (pEVR). RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the lower limit of detection (LLOD) for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360299|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360300|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360301|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360302|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360303|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360304|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360305|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360306|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360307|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360308|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360309|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360310|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360311|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360312|NCT01675427|Secondary|Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360313|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360314|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360315|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360316|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360317|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360318|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360353|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
1360319|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360320|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360321|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360322|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
1360323|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360324|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360325|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360326|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360327|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
1360328|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
1360329|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
1360330|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells per liter (10^9 cells/L).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
1360331|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360332|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360333|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360334|NCT01675427|Secondary|Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360335|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360336|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360337|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360338|NCT01675427|Secondary|Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 international units per liter [IU/L] for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
1360339|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
1360340|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
1360341|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
1364269|NCT01636258|Primary|"Effect of FRESH Program on Weight Loss"|Change in weight measured at baseline and followup (at 8-14 weeks).|Baseline line and final followup visit (at 8-14 weeks)||||kg||Standard Deviation|Mean
1360342|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
1360343|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
1360344|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kilopascals (kPa).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
1360345|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360346|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360347|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360348|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360349|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360350|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360351|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360352|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360354|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 international units per milliliter (log10 IU/mL).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
1360355|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360356|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360357|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360358|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360359|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg/m^2||95% Confidence Interval|Mean
1360360|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg/m^2||95% Confidence Interval|Mean
1360361|NCT01675427|Secondary|BMI by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg/m^2||95% Confidence Interval|Mean
1360362|NCT01675427|Secondary|Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kilograms per meter-squared (kg/m^2), and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg/m^2||95% Confidence Interval|Mean
1360363|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg||95% Confidence Interval|Mean
1360364|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg||95% Confidence Interval|Mean
1360365|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg||95% Confidence Interval|Mean
1360366|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kilograms (kg).|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg||95% Confidence Interval|Mean
1360367|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360368|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360373|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
1360374|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
1360375|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360376|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360377|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360378|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360379|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360380|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360381|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced): Only participants who had received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360382|NCT01675427|Primary|Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype (Genotype 1 [G1], Genotype 2 [G2], Genotype 3 [G3], Genotype 4 [G4], and all other genotypes [Other]) and cirrhosis status ('Cirrhosis/transition to cirrhosis' or 'No cirrhosis') were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1 (single study visit)|Core Analysis Population (Treatment-Naive): Only participants who had not received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
1360383|NCT01675167|Secondary|Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep|Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.|Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).|||participants|||Number
1360521|NCT01673698|Primary|Treatment Group Responder Rate Dichotomized at 25% EWL|An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of >25% EWL at 24 weeks was significantly greater than 35%.|24 weeks|By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.|||percentage of participants|||Number
1360384|NCT01675167|Secondary|Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).|||units on a scale||Standard Deviation|Mean
1360385|NCT01675167|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with RMDQ assessment at week 12 (n=225 buprenorphine and n=231 placebo).|||units on a scale||Standard Deviation|Mean
1360386|NCT01675167|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (19). Includes only participants with PGIC assessment at week 12 (n=231 buprenorphine and n=230 placebo).|||units on a scale||Standard Deviation|Mean
1360387|NCT01675167|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||percentage of participants|||Number
1360388|NCT01675167|Secondary|Time to Optimal Dose of Open-label Study Medication|"Overall time to reach the optimum dose of study medication required to progress to double-blind treatment"|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment|||days||Standard Deviation|Mean
1360389|NCT01675167|Secondary|Number of Subjects With Opioid Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary|Week 1 to Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||participants|||Number
1360390|NCT01675167|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||participants|||Number
1360391|NCT01675167|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||units on a scale||Standard Deviation|Mean
1360392|NCT01675141|Secondary|Expression of Cereblon (CRBN) and How it Relates to Natural Killer (NK) Cell Number and Activity|Relative fold change in CRBN and correlation (R2) to NK cell number and activity.|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
1360393|NCT01675141|Secondary|Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy|Percent change in total number of B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
1360394|NCT01675141|Secondary|Natural Killer (NK) Cell Function and Activity|Percent of target cell lysis by NK cells|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
1361994|NCT01660672|Other Pre-specified|Number of Subjects Exposed to Phenobarbitone Prior to Enrollment|Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated.|0 hour||||participants|||Number
1360395|NCT01675141|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from study entry until progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.|participants were followed for the duration of their treatment, an average of 2 years||||months||95% Confidence Interval|Median
1360396|NCT01675141|Secondary|Duration of Response|Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.|participants were followed for the duration of their treatment, an average of 2 years||||Months||95% Confidence Interval|Median
1360397|NCT01675141|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|37 months and 12 days||||Participants|||Count of Participants
1360398|NCT01675141|Primary|Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts|Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
1360399|NCT01675128|Secondary|Number of Participants With a Decrease in elF4E mRNA Expression in Peripheral Blood|Peripheral blood analysis of elF4E mRNA expression was performed using real time quantitative polymerase chain reaction (q-PCR) to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a decrease (criteria unavailable) in elF4E determines if the drug is working. Cell proliferation or reduction was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.|||participants|||Number
1360400|NCT01675128|Secondary|Number of Participants With a Reduced Effect of elF4E Inhibition on Relevant Regulated Proteins|Protein levels in the biopsy sample was assessed by immunohistochemistry using anti-oligonucleotide antibody to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a reduced effect (criteria unavailable) of elF4E inhibition on relevant regulated proteins determines if the drug is working.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.|||participants|||Number
1360401|NCT01675128|Secondary|Number of Participants With Intracellular and Stromal Presence of ISIS in Tumor Tissue|Intracellular and stromal presence of ISIS in tumor tissue was assessed by immunohistochemistry (IHC) and Crystal Violet staining to determine effectiveness of drug. Tissue that retains stain indicates intracellular and stromal presence of ISIS and determines if the drug is working. Relative staining intensity (intensity criteria unavailable) was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.|||participants|||Number
1360402|NCT01675128|Secondary|AUC(ALL) (Area Under the Plasma Concentration vs. Time Curve for All Time Points)|AUC(ALL) (Area under the plasma concentration vs. time curve for all time points) was assessed for CPT-11 (irinotecan), its active metabolite SN38, and the glucuronic acid metabolite of SN38, SN38-G to derive the total AUC(ALL).|up to 24 hours post end of infusion|Phase I Dose Level I and Phase I Dose Level II were grouped together for this outcome measure. Complete pharmacokinetic data for only ten of the fourteen participants enrolled on the phase I portion of the study were available for analysis. Data is unavailable to report each individual time point.|||hr*ng/mL||Standard Deviation|Mean
1360403|NCT01675128|Secondary|Overall Survival|Overall survival is defined as the time from the on study date until the date of death or date last known alive.|≥ 12 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, overall survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus overall survival data for Phase I Dose Level I.|||participants|||Number
1360404|NCT01675128|Secondary|Number of Participants With Progression Free Survival|Progression free survival is defined as the time beginning on the on study date and continuing until date of progression or date removed from study for an adverse event.|≤ 6 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, progression free survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there is no progression free survival data for Phase I Dose Level I.|||participants|||Number
1360522|NCT01673698|Primary|Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24|An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.|Week 24||||percentage of EWL||Standard Error|Mean
1360405|NCT01675128|Secondary|Objective Response|Objective response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% reduction in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of athe diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progression).|up to 2 cycles|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable for response. Per protocol, no responses were to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there are no objective responses for Phase I Dose Level I.|||participants|||Number
1360406|NCT01675128|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|21 months||||participants|||Number
1360407|NCT01675128|Primary|Number of Participants With a Change in elF4e Protein Levels in Matched Pre and Post Tumor Biopsies|A change in protein is defined as an increase or decrease compared to baseline and is measured between two time points by immunohistochemistry (IHC) analysis.|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.|||participants|||Number
1360408|NCT01675128|Primary|Number of Participants With a Change in the Level of a Particular Gene Called elF4E [Eukaryotic Initiation Factors (elF)4e Messenger Ribonucleic Acid (mRNA) Levels] in Matched Pre and Post Tumor Biopsies|A change in elF4e levels is defined as an increase or decrease compared to baseline and is measured between two time points before rand after 2 weeks of treatment by quantitative real-time reverse transcription polymerase chain reaction (qRT-PCR).|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.|||participants|||Number
1360409|NCT01675128|Primary|Maximum Tolerated Dose of Irinotecan in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years||||mg/m^2|||Number
1360410|NCT01675128|Primary|Maximum Tolerated Dose (MTD) of ISIS 183750 in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years||||mg|||Number
1360411|NCT01675063|Primary|Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output|The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data.|8 hours post cardiac surgery|patients had undergone routine cardiac surgery. some patients did not have PA catheters placed and subsequently data was not obtained on cardiac output.|||Participants|||Count of Participants
1360412|NCT01675050|Secondary|Abdominal Pain|Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the “Abdominal Pain Index – Child Version” (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).|10 weeks||||units on a scale||Standard Deviation|Mean
1360413|NCT01675050|Primary|Pressure Pain Threshold|Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.|at 4 weeks of cyproheptadine or placebo treatment||||kg/cm^2||Standard Deviation|Mean
1360414|NCT01675011|Primary|Primary Endpoint|The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.|12 Months post study procedure|The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.||||||
1360415|NCT01674725|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.|||percentage of participants||95% Confidence Interval|Number
1360416|NCT01674725|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population).|||percentage of participants|||Number
1360453|NCT01674634|Secondary|Clinical Success|Clinical success is defined as reduction of FFC of a treated joint to within 0-5 degrees of normal within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.|||Joints|Treated Joints||Number
1386250|NCT01394159|Primary|Compare the Median Number of Passes Required to Establish a Diagnosis||6 months||||No. of passes for diagnosis||Inter-Quartile Range|Median
1360417|NCT01674725|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1360418|NCT01674725|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b]) and had hemoglobin ≥ LLN reference range at baseline.|||percentage of participants|||Number
1360419|NCT01674725|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1360420|NCT01674712|Secondary|Cystatin C|Collection and measurement of blood samples|12 weeks|||||||
1360421|NCT01674712|Secondary|Total Bilirubin|Collection and measurement of blood samples|12 weeks|||||||
1360422|NCT01674712|Secondary|Plasma Creatinine|Collection and measurement of blood samples|12 weeks|||||||
1360423|NCT01674712|Secondary|Alanine Aminotransferase (ALT)|Collection and measurement of blood samples|12 weeks|||||||
1360424|NCT01674712|Secondary|Creatine Kinase (CK)|Collection and measurement of blood samples|12 weeks|||||||
1360425|NCT01674712|Secondary|Adverse Events|Collection and measurement of blood samples|12 weeks|||||||
1360426|NCT01674712|Secondary|Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)|Collection and measurement of blood samples|12 weeks|||||||
1360427|NCT01674712|Secondary|Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline|Collection and measurement of blood samples|12 weeks|||||||
1360428|NCT01674712|Secondary|Percentage of Apolipoprotein B From Baseline|Collection and measurement of blood samples|12 weeks|||||||
1360429|NCT01674712|Secondary|Percentage of Apolipoprotein AI From Baseline|Collection and measurement of blood samples|12 weeks|||||||
1360430|NCT01674712|Secondary|Percentage of TC (Triglyceride) From Baseline|Collection and measurement of blood samples|12 weeks|||||||
1360431|NCT01674712|Secondary|Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline|Collection and measurement of blood samples|12 weeks|||||||
1360432|NCT01674712|Primary|Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.|||percentage of change||Standard Deviation|Mean
1360433|NCT01674712|Primary|Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.|||percentage of change||Standard Deviation|Mean
1360434|NCT01674712|Primary|Percentage of Change of TG (Triglyceride)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.|||percentage of change||Standard Deviation|Mean
1360435|NCT01674647|Secondary|Number of Participants With Composite of Major and Non-major Bleeding Events|All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the SAF population. SAF population included all randomized subjects who received at least 1 dose of study medication.|||Participants|||Number
1360473|NCT01674010|Secondary|Time to Recurrence of a Depressive Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure||||||
1360474|NCT01674010|Secondary|Proportion of Study Participants With Recurrence of Any Mood Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure||||||
1360475|NCT01674010|Primary|Treatment Emergent Adverse Events|The study was terminated early so no efficacy analysis was done, safety data are reported.|up to 48 weeks|TEAEs reported for Phase 2 were from the entire study period|||participants|||Number
1360436|NCT01674647|Secondary|Number of Participants With All-cause Mortality|All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360437|NCT01674647|Secondary|Number of Participants With Cardiovascular Deaths|All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360438|NCT01674647|Secondary|Number of Participants With Myocardial Infarctions|All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360439|NCT01674647|Secondary|Number of Participants With Non-central Nervous System Systemic Embolisms|All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360440|NCT01674647|Secondary|Number of Participants With Transient Ischemic Attacks|All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360441|NCT01674647|Secondary|Number of Participants With Strokes|All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360442|NCT01674647|Secondary|Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality|Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360443|NCT01674647|Secondary|Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms|Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
1360444|NCT01674647|Primary|Number of Participants With Major Bleedings as Per Central Adjudication|Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the safety analysis set (SAF) population. SAF population included all randomized subjects who received at least 1 dose of study medication.|||Participants|||Number
1360445|NCT01674647|Primary|Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death|Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the modified intention-to-treat (mITT) population. mITT population included all the randomized subjects in whom a left atrial/left atrial appendage (LA/LAA) thrombus was not diagnosed during a transesophageal echocardiogram (TEE) performed before the first planned cardioversion in the study.|||Participants|||Number
1360446|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61|The URAM scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||units on a scale|Treated Joint Pairs|Standard Deviation|Mean
1360447|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31|The Unité Rhumatologique des Affections de la Main (URAM) scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||units on a scale|Treated Joint Pairs|Standard Deviation|Mean
1360448|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 61|Investigator's determined the degree of improvement in the severity of the subject’s treated finger(s) compared with screening at the day 61 follow-up visit.|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
1360449|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 31|Investigator's determined the degree of improvement in the severity of the subject’s treated finger(s) compared with screening at the day 31 follow-up visit.|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
1360450|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 61|Subject's were asked to rate satisfaction with treatment at the day 61 follow-up visit|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
1360451|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 31|Subject's were asked to rate satisfaction with treatment at the day 31 follow-up visit|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
1360452|NCT01674634|Secondary|Clinical Improvement|Clinical improvement is defined as a reduction of FFC by 50% or greater of the baseline value within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.|||Joints|Treated Joints||Number
1360476|NCT01673984|Secondary|Percentage of Participants Who Changed Injection Frequency After Completion of the Study||Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.|||percentage of participants|||Number
1360454|NCT01674634|Primary|Change From Baseline in Total Range of Motion|The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||degrees|treated joint pairs|95% Confidence Interval|Mean
1360455|NCT01674634|Primary|Percent Change From Baseline in Total Fixed Flexion|Percent change from baseline in total fixed flexion = 100 * (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.|Baseline, Day 31|Efficacy analysis was based on the modified intent-to-treat (mITT) population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on contralateral hand. Assessment is based on simultaneously treated joint pairs.|||percentage of contracture change|Treated Joint Pairs|Standard Deviation|Mean
1360456|NCT01674621|Secondary|Safety and Tolerability|Physical examinations, vital signs, electrocardiograms, clinical laboratory tests, local tolerance, and adverse events.|6 Months|||||||
1360457|NCT01674621|Secondary|Serum Markers of Bone Formation and Resorption|Change in laboratory results; active compared to placebo.|6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
1360458|NCT01674621|Secondary|BMD (Total Hip and Forearm)|Change in BMD, using DXA results; active compared to placebo.|6 Months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
1360459|NCT01674621|Primary|BMD (Lumbar Spine)|Change in BMD, using DXA results; active compared to placebo.|6 Months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
1360460|NCT01674569|Primary|Change From Baseline Visual Acuity at 6 Months|"The best corrected visual acuity by the Early Treatment Diabetic Retinopathy Study (ETDRS) method was determined at baseline and at various times during the study. The ETDRS method records the number of letters of decreasing size on a chart that a subject can read from a defiend distance.~During the study the ETDRS visual acuity was used to monitor the need for rescue therapy. The primary endpoint of the study was the change from baseline visual ETDRS visual acuity at 6 months. It was calculated by subtracting the baseline visual acuity from the visual acuity at 6 months for each individual subject. A positive change from baseline indicates improvement in visual acuity."|6 months|The mean and standard deviation was calculated for all subjects who completed 6 months of treatment with oral X82|||number of letters||Standard Deviation|Mean
1360461|NCT01674062|Secondary|Cohorts 1 and 2: Overall Survival (OS)|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. OS was defined as the time from first dose to the time of death from any cause. Participants who did not experience death were censored at the last known alive date. OS was estimated using Kaplan-Meier and expressed in months.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).|||months||80% Confidence Interval|Median
1360462|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants Who Died|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants|||Number
1360463|NCT01674062|Secondary|Cohorts 1 and 2: Progression-Free Survival (PFS) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. PFS was defined as the time from first dose to the time of disease progression or death. Participants without progression or death were censored at the last tumor assessment. PFS was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||weeks||80% Confidence Interval|Median
1360464|NCT01674062|Secondary|Cohorts 1 and 2: Time to Progression (TTP) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. TTP was defined as the time from first dose to the time of first documented disease progression. Participants who withdrew from the study without documented progression were censored at the last tumor assessment. TTP was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||weeks||Full Range|Median
1360477|NCT01673984|Secondary|Patient Satisfaction With Treatment.|Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.|Month 12|No participant analysis as no data was collected due to low number of participants recruited in the study.||||||
1361331|NCT01665053|Secondary|Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.|Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.|12 months|Intent-to-treat analysis|||percentage of participants|||Number
1360465|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants With Disease Progression According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants|||Number
1360466|NCT01674062|Secondary|Cohorts 1 and 2: Time to Objective Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine the OR rate. Time to response was defined as the time from first dose to the time of initial response of CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Participants with disease progression were censored at the time of progression, and those with neither disease progression nor OR were censored at the last tumor assessment. Time to response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 21 months (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression; final analysis using February 2008 cutoff date)|All Treated Population (Cohorts 1 and 2 only).|||weeks||Full Range|Median
1360467|NCT01674062|Secondary|Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine OR and CBR rates. Duration of OR was defined as time from initial response of CR or PR to time of disease progression or death. Duration of CBR was defined similarly as time from initial response of CR or PR, or SD lasting at least 6 months, to time of disease progression or death. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Participants without progression or death following confirmed CR or PR were censored at the last tumor assessment. Duration of response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||weeks||Full Range|Median
1360468|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or SD According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the CBR rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).|||percentage of participants||80% Confidence Interval|Number
1360469|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR or PR According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the OR rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).|||percentage of participants||80% Confidence Interval|Number
1360470|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or Stable Disease (SD) According to RECIST Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the clinical benefit response (CBR) rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants||80% Confidence Interval|Number
1360471|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants||80% Confidence Interval|Number
1360472|NCT01674010|Secondary|Time to Recurrence of a Manic/Hypomanic or a Mixed Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure||||||
1360478|NCT01673984|Secondary|Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)|TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.|6 and 12 month|Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.|||units on a scale||95% Confidence Interval|Mean
1360479|NCT01673984|Secondary|Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.|The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).|Baseline and Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.|||units on a scale||95% Confidence Interval|Mean
1360480|NCT01673984|Secondary|Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels|Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.|6 and 12 months|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.|||percentage of participants|||Number
1360481|NCT01673984|Secondary|Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..|12 months|Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.|||percentage of participants|||Number
1360482|NCT01673984|Primary|Percentage of Participants Maintaining Biochemical Castration|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.|6 months|Analysis based on intent-to-treat (ITT) population comprised of 21 patients.|||percentage of participants|||Number
1360483|NCT01673919|Secondary|Parent/Patient's Discomfort Index (Pain)|Participants or parents rated participant's pain by placing a horizontal line on a VAS of 0 (no pain) - 100 mm (unbearable pain). To describe the pain, a cut-off at 10 mm was used, and VAS <10 mm was defined as no pain.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
1360484|NCT01673919|Secondary|Parent/Patient's Global Assessment of Disease Activity|Parent/patient global assessment of disease activity was performed using 0 to 100 mm VAS, and higher the score of VAS, worse the disease status (0= absence of activity or sign or symptom; 100= maximal activity or signs or symptoms). No disease activity was defined as VAS <=10 mm.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
1360485|NCT01673919|Secondary|Physician’s Global Assessment of Disease Activity|The Physician's global assessment of disease activity was recorded on a 0 to 100 mm horizontal VAS where score 0 represented ‘arthritis inactive’ (i.e., symptom-free and no arthritis symptoms) and score 100 represented ‘arthritis very active’ (higher score indicate worsening of disease).|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||millimeter (mm)||Standard Deviation|Mean
1360486|NCT01673919|Secondary|Number of Painful Joints|The painful joints were counted by physical examination and mean painful joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
1360487|NCT01673919|Secondary|Number of Swollen Joints|The swollen joints was counted by physical examination and mean swollen joints were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
1360488|NCT01673919|Secondary|Number of Joints With Active Range of Motion|The active range of motion joints was counted by physical examination and mean joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
1360489|NCT01673919|Secondary|Number of Joints With Limitation of Motion|The most frequent symptom reported by most participants was a limitation of motion (LOM) of joints and it was determined by physical examination. The mean joints with limitation of motion were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
1360490|NCT01673919|Secondary|Number of Participants With a Minimally Important Improvement in the Childhood Health Assessment Questionnaire-Disability Index|The CHAQ-DI included questions on dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The disability index (DI) of the original CHAQ was graded on 4-point categorical scales of 30 items grouped into 8 domains of physical function. The highest scoring item in each domain determined the score for that domain. The score for the disability index was the mean of domain scores ranging from 0 to 3 (0 = without any difficulty and 3 = unable to do) with higher scores meaning higher disability. Minimally important improvement in CHAQ-DI was defined as a change from baseline of WA19977 core study (Day 1/Visit 1) >=0.13 at each visit.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
1360491|NCT01673919|Secondary|Number of Participants Achieving Clinical Remission|Clinical remission was defined as inactive disease observed for at least 6 continuous months. Clinical remission was defined as per medication uptake as: Level 1 (clinical remission on medication), Level 2 (clinical remission off oral corticosteroid medication [still on TCZ]), Level 3 (clinical remission off both oral corticosteroid and methotrexate medication [still on TCZ]), and Level 4 (clinical remission off all anti-inflammatory medications [still on TCZ]). Number of participants at each clinical remission level was reported.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
1360492|NCT01673919|Secondary|Number of Participants With Inactive Disease|Inactive disease was defined as: 1) No joints with active arthritis (no swollen, painful and lack of motion joints), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) No disease activity according to Physician's global assessment of disease activity (<= 10 millimeters [mm] on a VAS). The participant’s treating physician provided a rating of the participant’s arthritis disease activity on a 0 to 100 mm horizontal scale where score 0 represented ‘arthritis inactive’ (i.e., symptom-free and no arthritis symptoms) and score 100 represented ‘arthritis very active’.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
1360493|NCT01673919|Secondary|Number of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology Response 50/70|The Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) is comprised of six components: Maximum number of joints with active arthritis; Number of joints with limitation of movement; Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP); Childhood Health Assessment Questionnaire-Disease Index (CHAQ-DI) graded on 4-point scales [0 = without any difficulty and 3 = unable to do] of 30 items grouped into 8 domains of physical function; Physician’s global assessment of disease activity and Participant’s global assessment of overall well-being (both assessed on a 0 to 100 mm Visual Analogue Scale [VAS], where score 0 = inactive arthritis and 100 = very active arthritis). A JIA ACR50/70 response is defined as improvement in at least three of the six core components by at least 50 percent (%), or 70%, respectively and no more than one of the remaining core components worsening by more than 30%.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all participants who had at least one efficacy assessment. Number (n) = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
1360494|NCT01673919|Secondary|Number of Participants With Abnormality in Physical Examinations|Participants with abnormal physical examinations of ear, nose and throat (asthma); extremities (synovitis, sequelae with flexion of the 5th right proximal interphalangeal joint, hallux valgus, deviations of metatarsophalangeal joints, and callus under metatarsal head); lung (mild bronchospasm); skin (vitiligo and hematoma, fatty subcutaneous infiltration on the neck, cutaneous eruption, and scalp pediculosis); and musculoskeletal system (discomfort in right hip) were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
1360495|NCT01673919|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Parameters|Clinically significant abnormal parameters included eosinophil count, alanine aminotransferase, total bilirubin, and protein and blood in urine. Number of participants with these abnormal lab parameters was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
1360496|NCT01673919|Secondary|Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths|Number of participants with AEs leading to TCZ modification, AEs leading to death, anaphylaxis or serious hypersensitivity, and deaths were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
1360497|NCT01673919|Secondary|Mean Duration of Study Follow-Up|The participants were followed-up from Day 1 to last visit date (approximately 2 years). Mean time for which participants were followed up in the study was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||Months||Standard Deviation|Mean
1360498|NCT01673919|Secondary|Mean Exposure to Study Treatment|Participants received TCZ for Week 104 or when TCZ was commercially available for pcJIA participants, whichever comes first in France. The mean TCZ exposure (time from first to last administration) was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||Months||Standard Deviation|Mean
1360499|NCT01673919|Primary|Number of Participants With Adverse Events Related to Tocilizumab|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. Relatedness of any AEs was reported as possibly related, probably related, or remotely related to TCZ.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
1360500|NCT01673919|Primary|Number of Participants With Adverse Events of Special Interest|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. The AEs of special interests included gingival bleeding, tooth abscess, acarodermatitis, ear infection, gastroenteritis, herpes zoster ophthalmic, lice infestation, nasopharyngitis, oral fungal infection, oral herpes, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheitis, tracheobronchitis, urinary tract infection, menorrhagia, asthma, epistaxis, and hematoma.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
1360518|NCT01673828|Primary|Extended Glasgow Outcome Scale (GOS-E) Score|GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.|6 months after injury||||GOS-E Score||Standard Deviation|Mean
1360501|NCT01673919|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
1360502|NCT01673867|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1360503|NCT01673867|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||participants|||Number
1360504|NCT01673867|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||months||95% Confidence Interval|Median
1360505|NCT01673867|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1360506|NCT01673867|Primary|One-year Overall Survival (OS) Rate in All Randomized Participants|The one-year overall survival rate is a percentage, representing the fraction of all randomized participants who were alive following one year of treatment. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|12 months|All Randomized Participants|||percentage of participants||95% Confidence Interval|Number
1360507|NCT01673867|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CIs for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||months||95% Confidence Interval|Median
1360508|NCT01673867|Secondary|Progression-Free Survival (PFS) Rate at 12 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 12 months after randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method.|Randomization to 12 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1360509|NCT01673867|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response or complete response|||months||Full Range|Median
1360519|NCT01673802|Primary|Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT|CT scans were assessed for tumor visualization after use of Gadoxetate disodium|24 hrs|Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT|||participants|||Number
1360520|NCT01673698|Secondary|Weight Loss Maintenance Six Months Following Device Removal|Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.|48 weeks|By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.|||percentage of participant|||Number
1360510|NCT01673867|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.~Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression or death, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response (PR) or complete response (CR).|||months||Full Range|Median
1360511|NCT01673867|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All Randomized Participants|||percentage of participants||95% Confidence Interval|Number
1360512|NCT01673867|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||months||95% Confidence Interval|Median
1360513|NCT01673854|Other Pre-specified|Number of Participants With Adverse Events (AEs) Grade 3-4, Related AEs Grade 3-4, Related Serious Adverse Events (SAEs) Grade 3-4, Immune-related (ir) AEs Grade 3-4, and Serious irAEs Grade 3-4|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug|||Participants|||Number
1360514|NCT01673854|Other Pre-specified|Number of Participants Who Died, Who Died Due to Related Adverse Events (AEs), and With Related AEs, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to AEs and Related AEs, Immune-related (ir) AEs, and Serious irAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug|||Participants|||Number
1360515|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Hepatobiliary Adverse Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of vemurafenib and ipilimumab|||Percentage of participants||95% Confidence Interval|Number
1360516|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Gastrointestinal Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab.|||Percentage of participants||95% Confidence Interval|Number
1360517|NCT01673854|Primary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
1361332|NCT01665053|Secondary|Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.|TVR overall includes: TVR PCI & TVR CABG.|12 months|Intent-to- Treat|||percentage of participants|||Number
1360523|NCT01673620|Primary|Number of Participants Discontinuing Study Treatment Due to AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 2 weeks|The APaT population consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
1360524|NCT01673620|Primary|Number of Participants Experiencing at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 4 weeks|The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
1360525|NCT01673594|Primary|Safety|Number of adverse events throughout the course of the study|6 Weeks||||adverse events||Standard Deviation|Mean
1360526|NCT01673594|Primary|Change in Score on AISRS From Baseline to Week 6|The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.|Baseline and 6 Weeks||||units on a scale||Standard Deviation|Mean
1360527|NCT01673568|Secondary|Seroma Formation|Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.|postoperative day 7||||mL||Full Range|Median
1360528|NCT01673568|Primary|Visual Analog Scale of Pain Activity|Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.|24 hours after hernia repair||||units on a scale||Full Range|Median
1360529|NCT01673490|Secondary|Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points|The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Mililiter/seconds||Standard Deviation|Mean
1360530|NCT01673490|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6|The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.|Baseline and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1360531|NCT01673490|Primary|Free to Total PSA Ratio at the Indicated Time Points|Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.|Baseline, Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Ratio||Standard Deviation|Mean
1360532|NCT01673490|Primary|Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points|Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Microgram per liter (ug/L)||Standard Deviation|Mean
1360533|NCT01673490|Primary|Number Participants With a Negative or Positive Response at the Indicated Time Points|Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
1360534|NCT01673490|Primary|Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
1360577|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360535|NCT01673490|Primary|Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
1360536|NCT01673490|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
1360537|NCT01673490|Primary|Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|ITT Population|||Participants|||Number
1360538|NCT01673490|Primary|Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.|||Participants|||Number
1360539|NCT01673425|Secondary|Serum Antibody Response to LAIV||Change from baseline in serum antibody response at 6 weeks|||||||
1360540|NCT01673425|Primary|IgA Antibody Titers||Change from baseline in antibody titer at 6 weeks|This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.||||||
1360541|NCT01673347|Secondary|Range of Motion Dorsiflexion|Range of Motion Dorsiflexion|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants|||degrees||Standard Deviation|Mean
1360542|NCT01673347|Secondary|Range of Motion Plantarflexion|Range of Motion Plantarflexion|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants|||degrees||Standard Deviation|Mean
1360543|NCT01673347|Secondary|Pain|Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants|||units on a scale||Standard Deviation|Mean
1360544|NCT01673347|Primary|Allograft Stability|Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.|5-years postoperative|Study terminated prior to 5-year endpoint, no participants evaluated||||||
1360545|NCT01673282|Primary|The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)|Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.|From Baseline (Day 0) to 6 months|The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.|||percent change of ratio in dose||Standard Deviation|Mean
1360546|NCT01673256|Primary|Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.|"Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.~Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor."|4 days after Holter starts||||percentage||95% Confidence Interval|Number
1360547|NCT01673191|Primary|Mean Change in Intraocular Pressure||3 months||||millimeters of mercury (mm Hg)||Standard Deviation|Mean
1360548|NCT01673191|Primary|Mean Change in Central Retinal Thickness||3 months||||micrometers||Standard Deviation|Mean
1360549|NCT01673191|Primary|Mean Change in Central Retinal Thickness||2 months||||micrometers||Standard Deviation|Mean
1360550|NCT01673191|Primary|Mean Change in Central Retinal Thickness||1 month||||micrometers||Standard Deviation|Mean
1360551|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||3 months||||logMAR units||Standard Deviation|Mean
1360552|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||2 months||||logMAR units||Standard Deviation|Mean
1360553|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||1 months||||logMAR units||Standard Deviation|Mean
1360554|NCT01673178|Secondary|Apparent Clearance (CL) of PF-05231023|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liter/hour (L/hr)||Standard Deviation|Geometric Mean
1360555|NCT01673178|Secondary|Plasma Decay Half-Life (t1/2) of PF-05231023|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
1360556|NCT01673178|Secondary|Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose|Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
1360557|NCT01673178|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose|Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
1360558|NCT01673178|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ratio||Standard Deviation|Geometric Mean
1360559|NCT01673178|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ratio||Standard Deviation|Geometric Mean
1360560|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
1360561|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Full Range|Median
1360562|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
1360578|NCT01673178|Primary|Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram per liter (mcg/l)||Standard Deviation|Mean
1360563|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1360564|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
1360565|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1360566|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1360567|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1360568|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 1|Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively|||participants|||Number
1360569|NCT01673178|Primary|Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24||Day 24|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively|||mg/24 hours||Standard Deviation|Mean
1360570|NCT01673178|Primary|Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.|||milligram per 24 hours (mg/24hr)||Standard Deviation|Mean
1360571|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360572|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360573|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360574|NCT01673178|Primary|Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units per liter (U/L)||Standard Deviation|Mean
1360575|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360576|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1361995|NCT01660672|Other Pre-specified|Number of Subjects With Retinopathy at Enrollment|Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic.|Upon admission||||participants|||Number
1360579|NCT01673178|Primary|Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who receive at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360580|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360581|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
1360582|NCT01673178|Primary|Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram per milliliter (NG/ML)||Standard Deviation|Mean
1360583|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
1360584|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
1360585|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
1360586|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
1360587|NCT01673178|Primary|Creatine Phosphokinase (CPK) Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units per liter (U/L)||Full Range|Median
1360588|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
1360589|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
1360590|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
1360591|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
1360592|NCT01673178|Primary|Phosphate Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milligram per deciliter (mg/dL)||Full Range|Median
1360593|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
1360594|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 39||Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
1360595|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 25||Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
1360596|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 1||Day 1|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
1360597|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Baseline|Results are reported in micro international units per milliliter (mcIU/mL).|Baseline|Safety analysis set included all participants who received at least 1 dose of study medication.|||mcIU/mL||Standard Deviation|Mean
1360598|NCT01673178|Primary|Number of Participants With Abnormal Physical Examinations|Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.|Baseline up to Day 49|Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.||||||
1360599|NCT01673178|Primary|Number of Participants With Clinically Significant Electrocardiogram Findings|Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia’s formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1360600|NCT01673178|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1360601|NCT01673178|Primary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1360602|NCT01673178|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1360603|NCT01673126|Secondary|Influence of Time Since Insult on the Results||participants will be followed for the duration of 1 year|||||||
1360604|NCT01673126|Secondary|Influence of Etiology on the Results||participants will be followed for the duration of 1 year|||||||
1360605|NCT01673126|Secondary|Influence of Diagnosis on the Results||participants will be followed for the duration of 1 year|||||||
1360606|NCT01673126|Primary|Change in CRS-R Total Scores|"At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations~The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.~Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).~The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors."|Baseline and directly after the tDCS (20 minutes)||||units on a scale||Standard Deviation|Mean
1360607|NCT01673113|Secondary|Mechanical Detection Threshold (MDT)|MDT was evaluated using von Frey Filaments. The up-down method, which evaluates the threshold force for appearance and disappearance of a touch sensation reported by the subject, was used until 3 values were obtained. The values presented in the data table were averaged over all repeats.|48-72 hours post treatment|11 subjects were randomized to have right or left flank treated with cryolipolysis and the untreated flank served as internal control.|||grams|flanks|Inter-Quartile Range|Median
1360608|NCT01673113|Primary|Vibration Detection Threshold (VDT)|VDT was evaluated using a computerized vibrometer with 1cm2 contact probe placed perpendicularly on the skin (TSA-II, Medoc Inc., Ramat Yishai, Israel). This device gradually increased the vibration magnitude until the subject pressed a “stop” button to indicate when they first felt the vibration. This test was repeated 8 times. The values presented in the data table were averaged over all repeats.|within 48-72 hours after treatment|11 subjects were randomized to have right or left flank treated with cryolipolysis. The untreated flank served as the internal control.|||(um/sec)|flanks|95% Confidence Interval|Mean
1360609|NCT01673022|Primary|Estimate the Sensitivity of the Sentinel Lymph Node|To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.|3 years|Sensitivity of the sentinel lymph node|||Participants|||Count of Participants
1360610|NCT01673009|Secondary|Serum Bioactivity|The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)|7 days and 1 month|unable to measure this outcome because assay became unavailable||||||
1360611|NCT01673009|Primary|Percent Change From Baseline in Tumor Volume at 6 Months|Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease|baseline to 6 months||||percentage change of tumor volume||95% Confidence Interval|Median
1360612|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.|||Hounsfield Units||Standard Deviation|Mean
1360613|NCT01672996|Secondary|Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).|Recording the occurrence of treatment emergent adverse events (TEAE).|Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.|These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).|||Adverse Events|||Number
1360614|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.|||Hounsfield Units||Standard Deviation|Mean
1360615|NCT01672983|Secondary|Percentage of Participants With End of Treatment (EOT) Response|The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.|12 or 24 weeks after first dose of study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
1360616|NCT01672983|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)|The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|12 weeks after last dose of study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
1360617|NCT01672983|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.|TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.|Safety population: all participants who received at least 1 dose of study drug|||participants|||Number
1360618|NCT01672983|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|24 weeks after last dose of study drug|Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1360619|NCT01672970|Secondary|Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1360620|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1360621|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1360622|NCT01672970|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1361996|NCT01660672|Other Pre-specified|Number of Participants With Neurologic Sequelae at Discharge|Number of participants with neurologic sequelae at discharge|day 7||||participants|||Number
1360623|NCT01672970|Secondary|Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6|"The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1360624|NCT01672970|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1360625|NCT01672970|Secondary|Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1360626|NCT01672970|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1360627|NCT01672970|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1360628|NCT01672970|Secondary|Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1360629|NCT01672970|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of >2.8 to <=10.0 represented low disease activity, a score of >10.0 to <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1360630|NCT01672970|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician’s global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of >3.4 to <=11.0 represented low disease activity, a score of >11 to <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1365259|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 29 patients analyzed.|6 months|5 patients were lost to follow up|||percentage of ostia patent|Participants||Number
1360631|NCT01672970|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant’s disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1360632|NCT01672970|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant’s Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 <3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
1360633|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
1360634|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
1360635|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
1360636|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
1360637|NCT01672970|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||percentage of participants|||Number
1360638|NCT01672970|Secondary|Percentage of Participants on Tocilizumab Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1360639|NCT01672970|Secondary|Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ|A participant’s adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population|||percentage of participants|||Number
1360640|NCT01672970|Secondary|Number of Participants With Restoration of Initial Dosing Regimen of TCZ|The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.|6 months|Per protocol population|||participants|||Number
1360641|NCT01672970|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360642|NCT01672970|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||days||Standard Deviation|Mean
1361333|NCT01665053|Secondary|Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.|The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG).|12 months|Intent-to-Treat population|||percentage of participants|||Number
1360643|NCT01672970|Secondary|Mean Dose of TCZ at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||milligrams per kilogram {mg/kg)||Standard Deviation|Mean
1360644|NCT01672970|Secondary|Number of Participants With Reasons for Dose Modification for TCZ|Only those participants that had dose modifications were reported.|6 months|FAS population|||participants|||Number
1360645|NCT01672970|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360646|NCT01672970|Secondary|Percentage of Participants With Duration of Previous Biologic RA Treatments|The duration of previous biologic RA treatments was classified in to two categories: less than (<) 6 months and greater than (>) 6 months.|Baseline|Per protocol population included all participants who had a valid tocilizumab administration assessment at 6-month time window and without any protocol violations.|||percentage of participants|||Number
1360647|NCT01672970|Secondary|Number of Previous Biologic RA Treatments Received by Participants||Baseline|FAS population|||biologic treatments|||Number
1360648|NCT01672970|Secondary|Percentage of Participants With Reason for DMARDs Withdrawal at Baseline|DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360649|NCT01672970|Secondary|Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline|DMARDs exposure was evaluated for all participants. “Prior DMARDs treatment” included participants, who were treated with DMARDs 8 weeks according to physician’s discretion before being included in the study. “DMARDs treatment at baseline” included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ.|Prior to study (8 weeks) to Baseline|FAS population|||percentage of participants||95% Confidence Interval|Number
1360650|NCT01672970|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.|Baseline|FAS population|||percentage of participants||95% Confidence Interval|Number
1360651|NCT01672970|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1360652|NCT01672957|Secondary|Percentage of Participants With Graft Survival|Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation.|Months 1, 6, and 12|Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
1360653|NCT01672957|Secondary|Percentage of Participants With Acute Rejection|Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.|Baseline to Month 1, Months 2 to 6, Months 7 to 12|Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
1360654|NCT01672957|Secondary|Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil|Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.|Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
1360655|NCT01672957|Secondary|Mean Dose of Mycophenolate Mofetil||Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||milligrams (mg)||Standard Deviation|Mean
1360656|NCT01672957|Primary|GFR at Month 12 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 12|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.|||mL/min||Standard Deviation|Mean
1360657|NCT01672957|Primary|GFR at Month 6 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 6|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.|||mL/min||Standard Deviation|Mean
1360658|NCT01672957|Primary|Glomerular Filtration Rate (GFR) at Month 1 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure.|Month 1|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.|||mL/min||Standard Deviation|Mean
1365260|NCT01623050|Secondary|Number of Participants With Device-related Adverse Events as a Measure of Safety||3 months||||number of participants|||Number
1360659|NCT01672957|Primary|Creatinine Clearance at Month 12 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 12|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.|||mL/min||Standard Deviation|Mean
1360660|NCT01672957|Primary|Creatinine Clearance at Month 6 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 6|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.|||mL/min||Standard Deviation|Mean
1360661|NCT01672957|Primary|Creatinine Clearance at 1 Month After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 1|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.|||mL/min||Standard Deviation|Mean
1360662|NCT01672892|Secondary|Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported|Tissue samples will be obtained at the time of diagnosis and during the third week of radiation|||||||
1360663|NCT01672892|Secondary|Overall Survival|Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization until 3 years. (Patients are followed until death or study termination, whichever occurs first.)||2018-11-30|11/2018||||
1360664|NCT01672892|Secondary|Disease-free Survival|Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Evidence of distant metastases or new lymphadenopathy on surveillance imaging should be biopsied if possible to document disease recurrence. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.|From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.)||2018-11-30|11/2018||||
1360665|NCT01672892|Secondary|Local-regional Control|Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional control rates are estimated using the cumulative incidence method.|From randomization to 3 years. (Patients are followed until death or study termination, whichever occurs first.)||2018-11-30|11/2018||||
1360666|NCT01672892|Secondary|Health Utilities, as Measured by Change From Baseline in EQ-5D|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.|Baseline, week 5 of RT, 4-6 weeks after RT|Eligible patients with the questionnaire completed at baseline and respective follow-up time point|||units on a scale||Standard Deviation|Mean
1360667|NCT01672892|Secondary|Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale|The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.|Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT|Eligible patients with the questionnaire completed at baseline and respective follow-up time point|||units on a scale||Standard Deviation|Mean
1360677|NCT01672788|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1360668|NCT01672892|Secondary|Urinary Toxicity, as Measured by Change in EPIC Urinary Domain|The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score – baseline score so a negative change score indicates a decline in function.|Baseline, week 3 and 5 of RT, and 4-6 weeks after RT|Eligible patients with the questionnaire completed at baseline and respective follow-up time point|||units on a scale||Standard Deviation|Mean
1360669|NCT01672892|Secondary|Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Baseline to Week 5 of RT|Eligible patients with toxicity data|||percentage of participants||95% Confidence Interval|Number
1360670|NCT01672892|Secondary|Validation of EPIC Bowel and Urinary Domains|Since the EPIC has not been validated in this patient population, a secondary endpoint is to validate the bowel and urinary domains of EPIC in women undergoing either IMRT pelvic radiation treatment or four field pelvic radiation treatments for endometrial or cervical cancer. The bowel and urinary domains of the EPIC can be administered individually since they are separate and distinct modules of the robust and comprehensive EPIC tool.|Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT||2018-11-30|11/2018||||
1360671|NCT01672892|Primary|Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation|The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score – baseline score so a negative change score indicates a decline in function.|Baseline and week 5 of RT|Eligible patients with EPIC bowel domain completed at baseline and 5 weeks|||units on a scale||Standard Deviation|Mean
1360672|NCT01672827|Primary|Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).|||Percentage (True Negative)||95% Confidence Interval|Number
1360673|NCT01672827|Secondary|Inter-Reader Agreement of PET Images Without Anatomic Images|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.|Post Flutemetamol Injection||||Number of inter-reader agreements|||Number
1360674|NCT01672827|Primary|Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).|||Percentage (True Positive)||95% Confidence Interval|Number
1360675|NCT01672788|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1360676|NCT01672788|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1360687|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed|"Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.~The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.~The scores of the 3 trials are averages"|Pre-training, mid training, post training||||sec||Standard Deviation|Mean
1360678|NCT01672788|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1360679|NCT01672788|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1360680|NCT01672788|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1360681|NCT01672723|Other Pre-specified|Self-reported Physical Symptoms|"At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.~Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo."|once a day for 8 days||||units on a scale||Standard Deviation|Mean
1360682|NCT01672723|Secondary|Daily Self-reported Feelings of Social Connection|For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt (“I felt out of touch and disconnected from others”). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).|end of day for 8 days||||units on a scale||Standard Error|Mean
1360683|NCT01672723|Primary|Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)|Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by “not at all” and “very.” Higher numbers indicate greater feelings of connection in response to reading the loving messages.|participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment||||units on a scale||Standard Error|Mean
1360684|NCT01672658|Secondary|Dizziness Handicap Inventory|"A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.~Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)"|Pre-training, mid training, post training|This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.|||Units on a scale||Standard Deviation|Mean
1360685|NCT01672658|Secondary|Activities Balance Confidence Scale (ABC)|"Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.~16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: How confident are you that you will not lose your balance or become unsteady when you... Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items"|Pre-training, mid training, post training||||units on a scale||Standard Deviation|Mean
1360686|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open|"The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.~The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.~The scores of the 3 trials are averages"|Pre-training, mid training (4 weeks), post training (8 weeks)||||sec||Standard Deviation|Mean
1360688|NCT01672658|Secondary|Six Minute Walk Test|Assesses distance walked over 6 minutes|Pre-training, mid training (4 weeks), post training (8 weeks)||||Feet||Standard Deviation|Mean
1360689|NCT01672658|Secondary|10 Meter Walk Test|assesses walking speed of short duration|Pre-training, mid training (4 weeks), post training (8 weeks)||||m/s||Standard Deviation|Mean
1360690|NCT01672658|Primary|Functional Gait Assessment (FGA)|"Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.~10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment~= moderate impairment~= mild impairment~= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device"|Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)||||units on a scale||Standard Deviation|Mean
1360691|NCT01672658|Primary|Berg Balance Scale|The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)||||Units on a continuous scale||Standard Deviation|Mean
1360692|NCT01672294|Secondary|Caregiver Preparation|Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).|Measured at baseline, 5 weeks, and 8 weeks|Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate.|||units on a scale||Standard Deviation|Mean
1360693|NCT01672294|Secondary|Prolonged Grief - Number of Participants With Anticipatory Grief|The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.|Measured at baseline, 5 weeks, and 8 weeks|Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling.|||participants|||Number
1360694|NCT01672294|Secondary|Caregiver Completion|Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).|Measured at baseline, 5 weeks, and 8 weeks|Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data.|||units on a scale||Standard Deviation|Mean
1360695|NCT01672294|Secondary|Caregiver Burden|Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.|Measured at baseline, 5 weeks, and 8 weeks|Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data.|||units on a scale||Standard Deviation|Mean
1360696|NCT01672294|Secondary|Patient Days of VA Hospital Use|The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.|In the 6 months after randomization||||Days in VA hospital or ER||Standard Deviation|Mean
1360697|NCT01672294|Secondary|Depression|Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms|Measured at baseline, 5 weeks, and 8 weeks|Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.|||units on a scale||Standard Deviation|Mean
1360698|NCT01672294|Secondary|Spirituality|Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).|Measured at baseline, 5 weeks, and 8 weeks|Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.|||units on a scale||Standard Deviation|Mean
1360699|NCT01672294|Primary|Caregiver Anxiety|Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).|Measured at baseline, 5 weeks, and 8 weeks|Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.|||units on a scale||Standard Deviation|Mean
1360700|NCT01672242|Primary|Change in End-expiratory Lung Volume|Change in end-expiratory lung volume from baseline arbitrarily set at 0 mL.|baseline and after 3-5 minutes after each level of flow or pressure||||mL||Standard Deviation|Mean
1360701|NCT01671839|Secondary|Safe Treatment|Freedom from serious adverse events directly attributable to the Cabochon System or procedure.|Treatment to 3 years||||occurence of serious adverse events|||Number
1360702|NCT01671839|Secondary|Procedure Tolerability|Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).|||units on scale||Standard Deviation|Mean
1360703|NCT01671839|Secondary|Subject Satisfaction|"Subject rated satisfaction according to a 5 point Likert scale after treatment:~Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied"|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).|||percentage of subjects||95% Confidence Interval|Number
1360704|NCT01671839|Secondary|Improved Appearance|"Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 1 year after treatment. Change in the cellulite severity was rated according to 5 measures:~Very much improved: Optimal cosmetic result in the treated areas for this subject~Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition~Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude~No Change: The appearance of the treated areas is essentially the same as the original condition~Worse: The appearance of the treated areas is worse than the original condition"|Treatment to 3 years|The primary analysis was based upon the complete case population (CC).|||percentage of subjects||95% Confidence Interval|Number
1360705|NCT01671839|Secondary|Improvement in Cellulite Severity Grade|Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 year after treatment.|3-year|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing endpoint outcomes.|||percentage of subjects||95% Confidence Interval|Number
1360706|NCT01671839|Primary|Mean Change in Cellulite Severity|Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 1 year after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 1-year for the study population which was a minimum of 1 point lower than the baseline severity. Paired t-test test with a critical 1–sided alpha level of 0.025 was carried out on the mean Cellulite Severity Scale (0-5) change between 3 year and baseline visits.|Treatment to 3 years|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.|||units on a scale||95% Confidence Interval|Mean
1360707|NCT01671748|Secondary|Wound Recurrence Rate|Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.|90 days after time of healing|Three patients healed during the study period (one NLFU+SOC patient healed after 7 weeks and one after 8 weeks of NLFU+SOC treatment, and one patient who received standard care alone healed after 4 weeks). All three of these patients remained healed 90 days after the end of their study treatment.|||Number of wounds remained healed|||Number
1360708|NCT01671748|Primary|Actual Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|As previous|||cm2||Standard Deviation|Mean
1360709|NCT01671748|Secondary|Number of Non-serious Adverse Events in Each Group|Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.|Week 5 to 13||||Number of non-serious AEs|||Number
1360710|NCT01671748|Secondary|Incidence of Wound Infection|Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).|Weeks 5 to 13|All patients included; ITT.|||Number of infections per patient||Inter-Quartile Range|Median
1360711|NCT01671748|Secondary|Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)|Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.|Weeks 5 to 13||||scores on a scale||Standard Deviation|Mean
1360712|NCT01671748|Secondary|Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)|"On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values.~CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17"|Week 1 (start) and week 13 (exit)|All patients were analysed by ITT|||units on a scale||Inter-Quartile Range|Median
1360713|NCT01671748|Primary|Percentage Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|All patients included in the analysis; Intention to treat (ITT); Values have been adjusted for the influence of the covariate (wound area at the start of treatment)|||percentage change in wound area||Standard Deviation|Mean
1360839|NCT01670045|Secondary|Percentage of Participants With Different Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.|Baseline up to Day 5|ITT.|||percentage of participants|||Number
1360714|NCT01671605|Primary|In Vitro Lipoprotein Functions|Cholesterol efflux. Baseline and outcome measurements are the same. The cholesterol efflux was measured once using HDL isolated from CKD and control patients. There was no intervention,this assessment was performed once in each group. The measurement of cholesterol efflux is performed by an in vitro assay in cultured cells. Cells are loaded with cholesterol and maintained for 72 hours. The media of the cultured cells is then changed and the new media contains HDL from CKD or control patients. In additional cells, no HDL is added. The cells are maintained for 24 hours, and intracellular cholesterol is assessed. The cholesterol efflux represents the amount of cholesterol that was leached by HDL from each of our study groups. Thus, cells not exposed to any HDL will contain the highest intracellular cholesterol content. The amount of cholesterol in cells exposed to CKD HDL or control HDL reflects the efflux capacity of that HDL. This is expressed as percent of cholesterol removed by HDL.|Once, at enrollment||||Percentage of cholesterol content||Inter-Quartile Range|Median
1360715|NCT01671488|Secondary|To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.|"Patients terminating study treatment early prior to disease recurrence will be followed every 6 months for year 1 then annually for a total of 5 years. The follow-up portion will commence once patient comes off study or post the 2-6 week post the 4th treatment time point/visit.~Assessments were tumor evaluation via sigmoidoscopy, proctoscopy, colonoscopy or anoscope and also chest/abdomen/pelvic imaging."|Follow up and survival status at 6 months and 1 year post coming off study and annually until patient has been off for 5 years|As one patient expired prior to 6 month assessment, the total n used was 9 to assess PFS|||Participants|||Count of Participants
1360716|NCT01671488|Primary|To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.|Patients to undergo tumor evaluation assessment (via sigmoidoscopy, proctoscopy, colonoscopy or anoscope) 6 months post the start of chemotherapy/radiation.|Tumor evaluation 6 months after coming off study|Number of patient's who received treatment on study|||Participants|||Count of Participants
1360717|NCT01671488|Primary|To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.|Evaluate maximal toxicities via CTCAE version 4.0 All adverse events, serious and non-serious, were captured from date of ICF through 4 weeks post treatment completion- regardless of causality.|Baseline, then prior to each ADXS11-001 and weekly during radiation. Assessments 1-2 weeks post radiation then 2-6 weeks post vaccine and off study and 30 days post treatment.|Patient's who received treatment on study|||Participants|||Count of Participants
1360718|NCT01671319|Secondary|Incidence of Neuropathy|Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.|Up to 10 weeks|Of 42 participants, 41 were evaluable for outcome measure analysis.|||Participants|||Count of Participants
1360719|NCT01671319|Secondary|Incidence of Febrile Neutropenia|Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.|Up to 10 weeks|Of 42 participants, 41 were evaluable for outcome measure analysis.|||Participants|||Count of Participants
1360720|NCT01671319|Primary|Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy|Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.|4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks|Of 42 participants, 41 were evaluable for outcome measure analysis.|||participants|||Number
1360721|NCT01671293|Secondary|Change of Baseline in Waist Circumference|Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
1360722|NCT01671293|Secondary|Change of Baseline in Knowledge About Prediabetes|A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
1360723|NCT01671293|Secondary|Change From Baseline in Self Report of Dietary Practices|The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, & Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
1360724|NCT01671293|Secondary|Change From Baseline in Total Cholesterol|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL"|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
1360725|NCT01671293|Secondary|Change From Baseline in Triglycerides|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
1360726|NCT01671293|Secondary|Change From Baseline in Fasting Glucose|"Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
1365261|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 33 patients analyzed.|3 months|One patient was lost to follow up|||percentage of ostia patent|Participants||Number
1360727|NCT01671293|Secondary|Change From Baseline in Self Report of Physical Activity|The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
1360728|NCT01671293|Primary|Change From Baseline in Weight Parameter|Patient's weight wil be measured in kilograms using scales.|baseline and post intervention (6 -9 months after the first phone counseling session)||||kilograms||Standard Deviation|Mean
1360729|NCT01671280|Secondary|Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease|Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of PID (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."|||Percentage of Participants||95% Confidence Interval|Number
1360730|NCT01671280|Secondary|Clinical Effectiveness Rate in Participants With Pneumonia|Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of pneumonia (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."|||Percentage of Participants||95% Confidence Interval|Number
1360731|NCT01671280|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.|29 days|The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.|||Participants|||Number
1360732|NCT01671176|Primary|Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane|Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.|At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months||||units on a scale||Standard Deviation|Mean
1360733|NCT01671176|Primary|Holger's Scale|Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery|1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months||||participants|||Number
1360734|NCT01671111|Secondary|Change From Baseline in Serum Ferritin Values at Specified Visits|A negative change from baseline indicates that serum ferritin decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Weeks 24 and 48 of Cycle 1, Week 24 of Cycle 2|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.|||nanogram per milliliter||Standard Deviation|Mean
1360735|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 2)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.|||milliseconds||Standard Deviation|Mean
1360736|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 48 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.|||milliseconds||Standard Deviation|Mean
1360737|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.|||milliseconds||Standard Deviation|Mean
1360738|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 2)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.|||mg/g dry tissue||Standard Deviation|Mean
1360739|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 48 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.|||mg/g dry tissue||Standard Deviation|Mean
1360740|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal magnetic resonance imaging (MRI) data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|Full analysis set (FAS) included all participants in the Safety set who had at least 1 post-baseline primary efficacy assessment. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.|||milligram per gram (mg/g) dry tissue||Standard Deviation|Mean
1360741|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Pain|The VAS-Pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1360742|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Morning Stiffness|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1360743|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Fatigue|The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue, and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1360744|NCT01671059|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ is a participant self-reported questionnaire for assessing the extent of the participant’s functional ability. It consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale is an average of all the scores and ranges from 0 to 3, where higher scores represent higher disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1360745|NCT01671059|Secondary|Patient Global Assessment of Disease Activity Score|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1360746|NCT01671059|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)|An AESI includes serious/medically significant infections; opportunistic infections; cases of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), in combination with either elevated bilirubin or clinical jaundice; suspected transmission of an infectious agent by the study drug; myocardial infarction /acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis / hypersensitivity reactions (including injection site reactions); demyelinating disorders; stroke; serious/medically significant bleeding events; or serious/medically significant hepatic events.|6 months|Enrolled participants.|||percentage of participants|||Number
1360747|NCT01671059|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response|ACR response was calculated based on total joint count evaluation and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (28 joints) and tender joint count (28 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, participant's global assessment of disease activity (PGH), physician's global assessment of disease activity (PhGH) (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale); participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity); acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50 and ACR70 require a 50% and 70% improvement from baseline, respectively.|6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360748|NCT01671059|Secondary|Clinical Disease Activity Index (CDAI) Score|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1360749|NCT01671059|Secondary|Simplified Disease Activity Index (SDAI)|Simplified Disease Activity Index (SDAI) is an index for measuring disease activity in RA and has a good correlation with the DAS28. The index is calculated using the following formula: SDAI: swollen joint count (SJC28) + tender joint count (TJC28) + physician global assessment (PGA) (10 cm visual analogue scale [VAS]) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligrams/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores range from 0 to 86, with higher scores also indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1365262|NCT01623050|Primary|Patency of Treated Area||Immediately post procedure|Number of osita treated|||percentage of ostia treated|Participants||Number
1360750|NCT01671059|Secondary|Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360751|NCT01671059|Secondary|Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360752|NCT01671059|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
1360753|NCT01671059|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360754|NCT01671059|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy||6 months|Enrolled participants.|||percentage of participants|||Number
1360755|NCT01671059|Secondary|Percentage of Participants With Dose Interruptions||6 months|Enrolled participants.|||percentage of participants|||Number
1360756|NCT01671059|Secondary|Reasons for Dose Modifications||6 months|Enrolled participants who were evaluable for this outcome measure.|||participants|||Number
1360757|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents||Baseline|Enrolled participants.|||percentage of participants|||Number
1360758|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)||6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1360759|NCT01671059|Secondary|Percentage of Participants With Dose Modifications||6 months|Enrolled participants.|||percentage of participants|||Number
1360760|NCT01671059|Primary|Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation||6 months|Enrolled participants.|||percentage of participants|||Number
1360761|NCT01670825|Secondary|Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360762|NCT01670825|Secondary|Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360763|NCT01670825|Secondary|Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360764|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 months after the start of treatment||||days||Standard Deviation|Mean
1360765|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 months after the start of treatment||||days||Standard Deviation|Mean
1360840|NCT01670045|Secondary|Percentage of Participants With RA Diagnosis|"Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under unknown."|Baseline up to Day 5|ITT.|||percentage of participants|||Number
1360766|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|3 months||||days||Standard Deviation|Mean
1360767|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 3 months after the start of treatment||||days||Standard Deviation|Mean
1360768|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 weeks after the start of treatment||||days||Standard Deviation|Mean
1360769|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 weeks after the start of treatment||||days||Standard Deviation|Mean
1360770|NCT01670825|Secondary|Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360771|NCT01670825|Secondary|Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360772|NCT01670825|Secondary|Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360773|NCT01670825|Secondary|Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360774|NCT01670825|Secondary|Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360775|NCT01670825|Secondary|Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360776|NCT01670825|Primary|Change in Overall Worst Headache Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360777|NCT01670825|Primary|Change in Overall Average Headache Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360778|NCT01670825|Primary|Change in Overall Worst Headache Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360841|NCT01670045|Primary|Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation||Month 6|ITT.|||percentage of participants|||Number
1360779|NCT01670825|Primary|Change in Overall Average Headache Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360780|NCT01670825|Primary|Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360781|NCT01670825|Primary|Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360782|NCT01670825|Primary|Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360783|NCT01670825|Primary|Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360784|NCT01670825|Primary|Change in Worst Occipital Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360785|NCT01670825|Primary|Change in Average Occipital Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360786|NCT01670825|Primary|Change in Worst Occipital Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360787|NCT01670825|Primary|Change in Average Occipital Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360788|NCT01670825|Primary|Change in Worst Occipital Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360789|NCT01670825|Primary|Change in Average Occipital Pain 6 Months After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1360790|NCT01670825|Primary|Change in Worst Occipital Pain 6 Weeks After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360791|NCT01670825|Primary|Change in Average Occipital Pain 6 Weeks After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
1360842|NCT01670019|Secondary|Rates of Sustained Remission|"Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS < 7) is present.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|2, 4, 6 weeks|Participants that completed all data collection timepoints at week 2, 4, 6.|||participants|||Number
1360792|NCT01670721|Secondary|Change From Baseline in HRQL EQ-5D-3L VAS Score|EQ-5D VAS was used to record a participant’s rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Baseline corresponded to last evaluable assessment before treatment administration.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.|||units on a scale||Standard Deviation|Mean
1360793|NCT01670721|Secondary|Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.|||units on a scale||Standard Deviation|Mean
1360794|NCT01670721|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant’s assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment(either Aflibercept or FOLFIRI).Here, n=number of participants with available data at specified time-points.|||units on a scale||Standard Deviation|Mean
1360795|NCT01670721|Primary|Percentage of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the first dose of treatment to 30 days after the last dose of treatment (either Aflibercept or FOLFIRI). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days)|Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.|||Percentage of participants|||Number
1360796|NCT01670656|Secondary|Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2|Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Days of Ibuprofen Intake|||Days of ibuprofen intake||95% Confidence Interval|Least Squares Mean
1360797|NCT01670656|Secondary|Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2|Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Ibuprofen Tablets Taken|||Ibuprofen tablets||95% Confidence Interval|Least Squares Mean
1360814|NCT01670292|Primary|Lumbar-spine Stiffness (LSS)|"LSS* contains 5 variables: global stiffness (GS, unit: Newton/mm) at L3 from 1) hand palpation 2) a hand-held device & 3) an automated indenter device; global stiffness variation (GSV, unit: Newton/mm) between GS from L1 to L5 from 4) hand palpation & 5) a hand-held device.~*LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal."|Baseline, 2 weeks, 6 weeks|82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. The number of observations at each of the 3 time points for individual measures is equal to or lower than these numbers due to missing data.|||N/mm||Standard Deviation|Mean
1360798|NCT01670656|Secondary|Change From Baseline in Total Mean Impact Score Through Cycle 2|"Total Mean Impact Score is the mean of the sum of the daily responses to questions 6, 8, 9, and 10 in the Dysmenorrhea Daily e-Dairy, as recorded within the menstrual cramping pain analysis window. These questions assessed how much interference there was from pelvic cramping pain on work/school activities (Q6), physical activities (Q8), social/leisure activities (Q9) and sleep (Q10). Each question was rated on a 5-point (0-4) scale, with 0 being not at all, 1 slightly, 2 moderately, 3 quite a bit and 4 extremely. The total mean impact score could thus range from 0 (lowest possible impact) to 16 (highest possible impact)."|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Total Mean Impact Score|||Units on a scale||95% Confidence Interval|Least Squares Mean
1360799|NCT01670656|Primary|Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2|"The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: Cramps) in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe)."|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Menstrual Cramping Pain Score|||Units on a scale||95% Confidence Interval|Least Squares Mean
1360800|NCT01670526|Secondary|Twelve-week Change in Beck Depression Inventory-II (BDI-II)|"Beck Depression Inventory-II (BDI-II) is a validated 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depressive symptoms. Each answer is scored on a scale value of 0 to 3. Higher score indicates more severe depression.~To compare the differences in mean changes of BDI-II between two groups using two groups from baseline to week 12."|12 week||||units on a scale||Standard Deviation|Mean
1360801|NCT01670526|Secondary|Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)|"PCL-M is a validated 17-item self-report measure of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) symptoms of PTSD.The PCL-M asks about problems in response to stressful military experiences. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (extremely). Higher score indicates more stressful.~Comparison of difference in mean changes of PCL-M from baseline to 12-week follow-up between two groups."|12 week||||units on a scale||Standard Deviation|Mean
1360802|NCT01670526|Secondary|Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)|UPSA-B is a validated performance-based measure to evaluate the impact of rivastigmine-mediated memory improvements on the ability to perform tasks required for day-to-day functioning in two subdomains of financial management and communication. The scale goes from (0-100) and high score indicates better functions. Comparison of difference in mean changes of UPSA-B from baseline to 12-week follow-up between two groups.|12 weeks|Participants complete 12 weeks follow up included in this analysis.|||units on a scale||Standard Deviation|Mean
1360803|NCT01670526|Primary|Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall|The primary efficacy measure was the Hopkins Verbal Learning Test - Revised (HVLT-R) Total Recall Index. HVLT-R was administered at screen, baseline, weeks 4, and 12. The HVLT is a measure that assesses verbal learning and memory. Alternate versions of the HVLT-R were administered at each of the different time points. The test consists of 12 words which are read to participants for three consecutive trials, each trial followed by free recall. The Total Recall score is the total number of words recalled over the three trials. The primary endpoint evaluation was to compare the proportion of patients who demonstrated improvement from baseline on the HVLT-R Total Recall of at least 5-word and at week 12 between the treatment and placebo group.|week 12||||Participants|||Count of Participants
1360804|NCT01670487|Primary|Pain Score on the Numeric Rating Scale (NRS)|Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.|pain of intravenous catheter placement.|adults undergoing placement of an intravenous line in the emergency department|||NRS||Standard Deviation|Mean
1360805|NCT01670292|Secondary|Bothersomeness|"Question asked of participants: During the past week, how bothersome have each of the following symptoms been? The bothersomeness questionnaire contains two items: a) low back pain & b) leg pain (sciatica).~Scale: 0-10 (anchors: 0 = Not at all bothersome, 10 = Extremely bothersome)"|Baseline, 2 weeks, 6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. Number of observations made at the three time points were 82, 70, and 68, respectively.|||units on a scale||Standard Deviation|Mean
1360806|NCT01670292|Secondary|PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS|1) The PROMIS questionnaire contains 1 PROMIS global item: Pain NRS, Scale: 0-10 (anchors: 0 = No Pain, 10 = Worst Imaginable Pain, higher score is worse). The PROMIS global item is not scored but reported in raw score.|Baseline, 2 weeks, 6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. Number of observations made at the three time points were 82, 70, and 68, respectively.|||units on a scale||Standard Deviation|Mean
1360815|NCT01670292|Primary|Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)|"VAS - Visual Analog Scale - Scale: 0-100 mm (anchors: 0 mm = No Pain, 100 mm = Worst Imaginable Pain). VAS Interpretation: A higher score indicates greater pain intensity. In this study, improvement of 30% from the baseline value was considered clinically significant.~RMDQ - Roland Morris disability questionnaire - Scale: 0 (no disability) to 24 (maximum disability). RMDQ Interpretation: Greater levels of disability are reflected by higher scores. In this study, improvement of 30% from the baseline value was considered clinically significant."|Baseline to 6 weeks|82 and 68 participants completed at baseline and after 6 weeks, respectively. Data from all participants (n=82) were used in statistical analysis. The reported data represents the mean change from baseline to week 6.|||units on a scale (see description above)||95% Confidence Interval|Mean
1361367|NCT01664533|Secondary|Percentage of Participants Who Developed Rash||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.|||percentage of participants||95% Confidence Interval|Number
1360807|NCT01670292|Secondary|PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale|"1) The questionnaire contains 7 PROMIS-29 specific items: Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction with Participation in Social Role (anchors: 1= 'Not at all', 5= 'Very much', higher score is worse).~Each PROMIS-29 specific item is reported in raw score (4-20) and scored in T-score (T), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for a population.~On the T-score metric & interpretation:~A score of 40 is one SD lower than the mean of the reference population.~A score of 60 is one SD higher than the mean of the reference population.~For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured."|Baseline, 2 weeks, 6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. Number of observations made at the three time points were 82, 70, and 68, respectively.|||T-score||Standard Deviation|Mean
1360808|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment|"SSL* contains variables: rate of loading for moment in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton*Meters/second|Spinal Manipulations|Standard Deviation|Mean
1360809|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force|"SSL* contains variables: rate of loading for force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton/second|Spinal Manipulations|Standard Deviation|Mean
1360810|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Moment|"SSL* contains variables: maximum amplitude (Newton*Meter for moment) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton*Meter|Spinal Manipulations|Standard Deviation|Mean
1360811|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Force|"SSL* contains variables: maximum amplitude (Newton) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton (N)|Spinal Manipulations|Standard Deviation|Mean
1360812|NCT01670292|Primary|Flexion-Relaxation Ratio (FRR)|"FRR contains 4 variables, which are the average right and left back muscle FRR obtained using 1) maximum EMG during flexion, and 2) maximum EMG during extension to normalize EMG during full flexion; and asymmetry between the right and left back muscle FRRs using 3) maximum EMG during flexion, and 4) maximum EMG during extension to normalize EMG during full flexion~FRR Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal."|Baseline, 2 weeks, 6 weeks||||ratio||Standard Deviation|Mean
1360813|NCT01670292|Primary|Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation|"LSS contains 2 variables: Palpatory and Handheld device - normalized global stiffness variation (nGSV, unitless).~LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, lower than normal."|Baseline, 2 weeks, 6 weeks||||unitless||Standard Deviation|Mean
1360816|NCT01670279|Primary|Change From Baseline to Study Completion in C-SSRS Score.|The C-SSRS was one of the primary parameters to measure the safety and tolerability of individual participants. Suicidality was monitored during the trial using the C-SSRS. This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last trial visit.|Baseline, End of Titration, Fixed dose Day 14 and 28, Day 15 and 29, Early Termination, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Participants|||Number
1360817|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The AIMS Scale was an EPS rating scale. The AIMS is a 12 item scale. The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1360818|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The Barnes Akathisia Rating Scale was an EPS rating scale. The Barnes Akathisia Rating Scale was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1360819|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
1360820|NCT01670279|Primary|Incidence of Physical Examination Evaluation of Potential Clinical Significance|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Physical examination was performed at Screening, check-in, and discharge|Safety Sample was analyzed. Any clinically significant condition present at the post-treatment physical examination that was not present at the baseline examination was documented as an adverse event and followed to a satisfactory conclusion. There were no clinically significant physical examination findings reported in this study.|||Participants|||Number
1360821|NCT01670279|Primary|Incidence of ECG Evaluations of Potential Clinical Significance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Titratrion Day 1 and 7, Fixed dose Day 1, 14, 28, Early Termination|The safety dataset included all randomized participants who received at least one dose of study medication.|||Participants|||Number
1360822|NCT01670279|Primary|Incidence of Vital Signs of Potential Clinical Significance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Titration Day 1, 2, 7, 8, Fixed Days 1, 2, 14, 15, 28, 29, Early Termination and Last Visit.|The safety dataset included all randomized participants who received at least one dose of study medication.|||Participants|||Number
1360823|NCT01670279|Primary|Incidence of Laboratory Values of Potential Clinical Significance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Titration Day 7, Fixed dose Day 14 and 28 and Last Visit|The safety dataset included all randomized participants who received at least one dose of study medication.|||Participants|||Number
1360824|NCT01670279|Primary|Number of AEs Reported.|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial. AEs were measured throughout the 14-day titration and 28-day fixed dose phase until follow-up (30 [±2] days after last dose of study medication).|Throughout the study, up to 119 days|The safety dataset included all randomized participants who received at least one dose of study medication.|||Events|||Number
1360836|NCT01670045|Secondary|Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline|The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant’s global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.|Baseline, Month 1, 2, 3, 4, 5, 6|ITT.|||percentage of participants|||Number
1360837|NCT01670045|Secondary|Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status|"Percentage of participants with anti-CCP status were reported as positive, negative and unknown."|Baseline up to Day 5|ITT.|||percentage of participants|||Number
1360825|NCT01670279|Primary|Number of Participants Who Tolerated Brexpiprazole|Safety and tolerability of brexpiprazole was noted to be primary outcome measure. Brexpiprazole was judged to be tolerated if at least 6 out of 8 (75%) of the participants in a test cohort tolerated the dose after 14 days of QD dosing at the end of the fixed dose phase based on the blinded data. Dose toleration was defined as follows: during the course of the trial, the participants did not experience any moderate or severe adverse events (AEs) or potentially clinically relevant changes from Baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, Columbia-Suicide Severity Rating Scale (C-SSRS), or extrapyramidal symptom (EPS) ratings, which were assessed as possibly related to the study drug, and would have warranted a dose decrease or discontinuation of the study drug. The safety and tolerability of brexpiprazole was defined by parameters: AEs, laboratory values, vital signs, ECG, C-SSRS, or EPS ratings, the results of each of the parameters reported separately.|45 Days|Tolerability assessed in phase 1 trial in healthy participants (18-45 years) with MDD as adjunct therapy to ADTs; the efficacy assessed in phase 3 trials in participants (18-65 years) with MDD as adjunct therapy to ADTs. Thus, safety/tolerability of brexpiprazole in participants (>65 years) with MDD as adjunct therapy to ADTs was not characterized.|||participants|||Number
1360826|NCT01670201|Primary|Percentage of Participants Who Had > 95 % Epithelialization at Day 10||10 days||||percentage of participants|||Number
1360827|NCT01670201|Secondary|Pain at Dressing Changes|"The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.~Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),~Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst."|28 days||||units on a scale VAS 0-100||Full Range|Median
1360828|NCT01670188|Primary|Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis|Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter|baseline to 14 days post insertion of PICC line||||Participants|||Count of Participants
1360829|NCT01670045|Secondary|Percentage of Participants With Tocilizumab Dose Modifications||Baseline up to Month 6|ITT.|||percentage of participants|||Number
1360830|NCT01670045|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.|Baseline, Months 3, 6|"ITT. Here number of participants analyzed included evaluable participants for the outcome measure and n included evaluable participants at specified time point."|||mm||Standard Deviation|Mean
1360831|NCT01670045|Secondary|Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids|Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.|Baseline, up to Month 6|ITT.|||participants|||Number
1360832|NCT01670045|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria|ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].|Month 1, 2, 3, 4, 5, 6|ITT.|||percentage of participants|||Number
1360833|NCT01670045|Secondary|Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)|The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity’. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is ‘remission’, score > 2.8 and ≤ 10 is ‘low disease activity’, score > 10 and ≤ 22 is ‘moderate disease activity’, score > 22 is ‘high disease activity’. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.|||participants|||Number
1360834|NCT01670045|Secondary|Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)|The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity’. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is ‘remission’, score > 3.3 and ≤ 11 is ‘low disease activity’, score > 11 and ≤ 26 is ‘moderate disease activity’, score > 26 is ‘high disease activity’. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.|||participants|||Number
1360835|NCT01670045|Secondary|Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >1.2 points, score of >5.1 and DAS28 improvement of >1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of >3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of >5.1 and DAS28 improvement of >0.6 to ≤1.2 points, score of >5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.|Baseline up to Month 6|ITT.|||participants|||Number
1361368|NCT01664533|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until death from any cause.|Up to 2 years||||months||95% Confidence Interval|Median
1360843|NCT01670019|Secondary|Clinical Remission Rate|"Clinical Remission will be defined as the number of participants with a MADRS total score < 7.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|6 weeks||||participants|||Number
1360844|NCT01670019|Secondary|Clinical Response Rate|"Clinical Response rate will be defined as the number of participants with a > 50% reduction from baseline in MADRS total score.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks||||participants|||Number
1360845|NCT01670019|Secondary|Study Completion Rate|The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks|6 weeks||||percentage of participants|||Number
1360846|NCT01670019|Primary|Change in MADRS Total Score|"The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks|Analysis includes those participants who completed week 6 assessment.|||units on a scale||Standard Deviation|Mean
1360847|NCT01669902|Secondary|Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study||Baseline to Month 6|Safety Analysis Set|||participants|||Number
1360848|NCT01669902|Secondary|Percentage of Participants With Concomitant Corticosteroids Treatment||Baseline to Month 6|Safety Analysis Set|||percentage of participants|||Number
1360849|NCT01669902|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 3 and Month 6|The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.|||units on a scale||Standard Deviation|Mean
1360850|NCT01669902|Secondary|Percentage of Participants With Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (>) 240 minutes, or whole day.|Baseline, Month 3, Month 6|FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360851|NCT01669902|Secondary|Percentage of Participants With Morning Stiffness|The percentage of participants with morning stiffness (“yes”, “no”, or “do not know”) was assessed at each visit.|Baseline, Month 3, Month 6|FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360852|NCT01669902|Secondary|Patient Global Assessment of Pain|Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.|Baseline, Month 3, Month 6|The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.|||mm||Standard Deviation|Mean
1360853|NCT01669902|Secondary|Percentage of Participants in a PGA of Disease Activity Score Category|A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.|Baseline, Month 3, Month 6|FAS (categorical scale [physician]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360854|NCT01669902|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [physician] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.|||mm||Standard Deviation|Mean
1360855|NCT01669902|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [patient]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.|||mm||Standard Deviation|Mean
1360856|NCT01669902|Secondary|Number of Participants With an American College of Rheumatology (ACR) Response|ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.|Baseline to Month 6|Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.||||||
1360899|NCT01669629|Secondary|Binocular Snellen Visual Acuity|Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.|||percentage of eyes|Eyes||Number
1389178|NCT01364896|Primary|Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58||Baseline and 6 to 12 months||||percentage of participants|||Number
1360857|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3 and Month 6|FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360858|NCT01669902|Secondary|Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
1360859|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Month 3 and Month 6|FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360860|NCT01669902|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
1360861|NCT01669902|Secondary|Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)|The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360862|NCT01669902|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)|The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360863|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360864|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [ESR]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [ESR] assessment. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
1360900|NCT01669629|Secondary|Subject Reported Overall Vision|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.|6-10 Days||||percentage of participants|||Number
1360901|NCT01669629|Secondary|Subject Reported Overall Comfort|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.|6-10 Days||||percentage of participants|||Number
1360865|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) < 2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
1360866|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (<= 3.2) implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (<) 2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [CRP]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [CRP] assessment. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
1360867|NCT01669902|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.|||tender joint count||Standard Deviation|Mean
1360868|NCT01669902|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.|||swollen joint count||Standard Deviation|Mean
1360869|NCT01669902|Secondary|Percentage of Participants With Dose Modifications of Tocilizumab|Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.|Baseline to Month 6|Safety Analysis Set|||percentage of participants|||Number
1360870|NCT01669902|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6||Month 6|Safety Analysis Set|||percentage of participants|||Number
1360871|NCT01669863|Other Pre-specified|Change in Oxygenation Index During Application of ECMO|Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay|Duration of ICU stay|Data for this outcome were not collected. We intended to measure the PaO2/FiO2 ratio in all patients anticipating that all patients would be mechanically ventilated, either invasively or non-invasively. However, it turned out that most patients did not require mechanical ventilation while on ECMO.||||||
1360872|NCT01669863|Secondary|Number of Participants Who Presented With ECMO-Related Complications|ECMO-related complications|Duration of ICU stay||||participants|||Number
1360873|NCT01669863|Primary|Number of Participants That Did Not Require Endotrachael Intubation|- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.|Duration of ICU stay||||participants|||Number
1360874|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -sleep disturbance at baseline were included.|||Percentage of participants|||Number
1360875|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -difficulty of swallowing at baseline were included.|||Percentage of participants|||Number
1360876|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -abdominal pain at baseline were included.|||Percentage of participants|||Number
1360877|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -acid regurgitation at baseline were included.|||Percentage of participants|||Number
1360878|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -heartburn at baseline were included.|||Percentage of participants|||Number
1360879|NCT01669811|Secondary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 4 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 4 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Number
1360880|NCT01669811|Primary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 8 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 8 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|8 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Number
1360881|NCT01669785|Secondary|Long-term Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days post-prophylaxis treatment.||||units on a scale||Standard Deviation|Mean
1360882|NCT01669785|Secondary|Post-prophylaxis Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately following post-prophylaxis treatment.||||units on a scale||Standard Deviation|Mean
1360883|NCT01669785|Secondary|Post- Scaling Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Post-scaling procedure,immediate||||units on a scale||Standard Deviation|Mean
1360884|NCT01669785|Primary|Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score Schiff air blast measurements long term after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.||||units on a scale||Standard Deviation|Mean
1360885|NCT01669785|Primary|Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score via air blast measurements immediately after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .||||units on a scale||Standard Deviation|Mean
1360902|NCT01669629|Primary|Subject Reported Ease of Removal|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.|6-10 Days|Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.|||percentage of participants|||Number
1360886|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Air Blast Sensitivity)|"Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement||||units on a scale||Standard Deviation|Mean
1360887|NCT01669785|Secondary|Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity prior to the baseline assessments.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-Treatment||||units on a scale||Standard Deviation|Mean
1360888|NCT01669785|Primary|Long-term Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile measurements long term after treatment.~Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.||||grams||Standard Deviation|Mean
1360889|NCT01669785|Primary|Immediate Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .||||grams||Standard Deviation|Mean
1360890|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Tactile Sensitivity)|"Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement||||grams||Standard Deviation|Mean
1360891|NCT01669720|Secondary|Number of Participants Who Experienced a Toxicity Profile of Adjuvant Ziv-aflibercept, up to 2-years of Duration, for Patients Who Previously Received Systemic Perioperative Therapy (Regimen) and Surgical Resection/Ablation.|Toxicity defined by CTCAE Version 4.0 toxicities|Throughout study treatment until 30 days post off study, approximately 2 years|Data table reflects total number of patients who experienced a toxicity on study.|||Participants|||Count of Participants
1360892|NCT01669720|Primary|Number of Patients Who Progressed|Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.|Every 3 months until disease progression (for up to 2 years).||||participants|||Number
1360893|NCT01669642|Other Pre-specified|Total Sedation Time|during recovery, all participants are monitored for recovery to baseline at which point participants are ready for discharge. we will document the time from induction to recovery to aldrete score of 10.|documented during procedural sedation while in the hospital||||minutes||Full Range|Median
1360894|NCT01669642|Secondary|Number of Participants With Wisconsin Sedation Scale Score of 2 or Less at 1 Minute After First Dose of Ketamine|This is a measure of sedation effectiveness; to assess the effectiveness of first dose of ketamine administered.|during sedation, while patient is in the hospital||||participants|||Number
1360895|NCT01669642|Secondary|Vomiting|patients who experienced vomiting while in the ED or after discharge|one week after discharge from ED||||Participants|||Count of Participants
1360896|NCT01669642|Primary|ED95|ED95 is the dose of ketamine effective for 95% of children. this outcome is estimated from ED50.|february 2018||||mg/kg of ketamine dose|||Number
1360897|NCT01669642|Primary|to Find the Median Effective Dose (ED50) and ED95 of Rapidly Administered Ketamine|ED50 is the dose of rapidly administered ketamine that achieves effective sedation in 50% of patients. ED95 is the dose of ketamine that can provide effective sedation in 95% of children undergoing abscess drainage or fracture reduction. ED95 will be calculated for the 3 age groups (2-5, 6-11 and 12-17) independently for both the procedures: abscess drainage and fracture reduction.|36 months from study start|100 children were enrolled in 5 different groups depending on the age and type of procedure.|||mg/kg of ketamine dose||Full Range|Median
1360898|NCT01669629|Secondary|Overall Corneal Staining|"Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.~Grade 1 or higher is reported as a percentage of total eyes."|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.|||percentage of eyes|eyes||Number
1360903|NCT01669603|Primary|Interleukin-8 (IL-8)|Nasal lavage will be performed to collect and measure IL-8.|72 hours|analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study|||pg/ml||Standard Deviation|Geometric Mean
1360908|NCT01669434|Secondary|Low Blood Pressure Subgroup|Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg.|During anesthesia, an expected average of 3 hours.||||Participants|||Count of Participants
1360909|NCT01669434|Secondary|Acute Renal Failure|Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level|Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.|Missing outcome data for 37 patients, 18 in the ACEI omission arm and 19 in the ACEI continuation arm|||Participants|||Count of Participants
1360910|NCT01669434|Primary|Number of Participants With Interoperative Hypotension|Systolic Blood Pressure under 80 mmHg|During anesthesia, an expected average of 3 hours.||||Participants|||Count of Participants
1360911|NCT01669174|Secondary|AUC0-56 and AUClast|AUC0-56, the area under the serum concentration-time curve from the time zero to the end of the dosing interval, day 56. AUC0-56 was analyzed for dose 1 and 2. AUClast is from time zero to the last quantifiable concentration. AUClast was analyzed for dose 2 only.|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||day*ug/mL||Standard Deviation|Mean
1360912|NCT01669174|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|The time to reach the maximum concentration after drug administration|24 weeks|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||hr||Full Range|Median
1360913|NCT01669174|Secondary|Maximum Observed Serum Concentration (Cmax)|The observed maximum plasma concentration following drug administration|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||ug/mL||Standard Deviation|Mean
1360914|NCT01669174|Secondary|Change in 6 Minute Walk Distance Compared to Placebo|Practical simple test that requires a 100-ft hallway but no exercise quipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD)|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame|||meter||Standard Deviation|Mean
1360915|NCT01669174|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 4,8,16 and 24 was considered responders.|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||Percentage Change of TMV||Standard Deviation|Mean
1360916|NCT01669148|Primary|Detection of Breast Cancer (Sensitivity)|"Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):~Sensitivity = TP / (TP+FN)"|up to two years follow up for development of breast cancer|PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.||||||
1360917|NCT01669122|Secondary|Plasma Half Life (t1/2)|Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||hours||Standard Deviation|Mean
1360918|NCT01669122|Secondary|Rate of Elimination (Kel)|Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||1/ hour||Standard Deviation|Mean
1360919|NCT01669122|Secondary|Time to Maximum Plasma Concentration (Tmax)|Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||hours||Full Range|Median
1360920|NCT01669122|Secondary|AUC(0-inf)|Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined. AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||ng*hr/mL||Standard Deviation|Mean
1360921|NCT01669122|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||ng/mL||Standard Deviation|Mean
1360922|NCT01669122|Primary|Area Under the Curve From Time 0 to t, AUC (0-t)|Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|Per protocol (PP) population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||nanograms (ng)*hours (h)/milliliter (mL)||Standard Deviation|Mean
1360923|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~-max elasticity of clot on thromboelastography"|30 days post-treatment||||"Pascal"||Standard Deviation|Mean
1389558|NCT01362205|Secondary|Resource Utilization Costs Associated With This Hospitalization Billed by Physicians.||up to 28 Days||||Dollar (United States)||Inter-Quartile Range|Median
1360924|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- slope of clot formation dynamics"|30 days post-treatment||||"Pascal/min"||Standard Deviation|Mean
1360925|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~-dynamics of clot formation: clot onset time and clot complet"|30 days post-treatment||||"sec"||Standard Deviation|Mean
1360926|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~RAGE gene expression~Arbitrary unit was relative to the control gene expression (control gene = 1)"|30 days post-treatment||||arbitrary unit relative to control gene||Standard Deviation|Mean
1360927|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estrone and Norepinephrine.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- estrone, norepinephrine."|30 days post-treatment||||"pg/dL"||Standard Deviation|Mean
1360928|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Biomarkers|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone."|30 days post-treatment||||"microUI/mL"||Standard Deviation|Mean
1360929|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Platelet Aggregation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- platelet aggregation by ADP and norepinephrine."|30 days post-treatment||||percentage platelet aggregation||Standard Deviation|Mean
1360930|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estradiol|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- estradiol"|30 days post-treatment||||"pg/mL"||Standard Deviation|Mean
1360931|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Apolipoproteins AI and B.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- apolipoproteins AI and B"|30 days post-treatment||||"g/dL"||Standard Deviation|Mean
1360932|NCT01668836|Primary|Sirtuin|Sirtuin plasma levels before and 30 days post-treatment|30 days post-treatment||||ng/mL||Standard Deviation|Mean
1360933|NCT01668836|Other Pre-specified|Differences Between Men and Women.|We will also compare women vs men baseline and final data.|30 days|||||||
1360934|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose."|30 days post-treatment||||"mg/dL"||Standard Deviation|Mean
1360935|NCT01668836|Primary|Direct Evaluation of the Sirtuin 1 Gene Expression|"The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. Arbitrary unit was relative to the control gene expression (control gene = 1)."|30 days post-treatment||||arbitrary unit relative to control gene||Standard Deviation|Mean
1360936|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360937|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360938|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360939|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360940|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360941|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360942|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360943|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360944|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360945|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1361166|NCT01667029|Secondary|Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)|Number of days breakthrough pain medication was taken|Assessed during two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||days||Standard Deviation|Mean
1360946|NCT01668797|Other Pre-specified|Mean Change From Baseline in PEC Score - LOCF Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360947|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Excited Component (PEC) Score - MMRM Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The last-observation-carried-forward (LOCF) data set included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data (eg.the last visit prior to the first dosing of Phase C) were not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360948|NCT01668797|Other Pre-specified|Percentage of Participants Who Discontinued Due to All Causes|Analysis of the percentage of participants who discontinued due to all causes was based on all participants who have been randomized and taken one dose of IMP in the Double-blind Maintenance phase. The trial was completed by sponsor when efficacy was demonstrated at the first pre-specified interim analysis (45 impending relapse events) performed by an independent (unblinded) statistician.|Baseline to Week 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Percentage of particpants|||Number
1360949|NCT01668797|Other Pre-specified|Mean Change From Baseline in GAF Scale Score - LOCF Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360950|NCT01668797|Other Pre-specified|Mean Change From Baseline in Global Assessment of Functioning (GAF) Scale Score - MMRM Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360951|NCT01668797|Other Pre-specified|Mean Change From Baseline in PSP Scale Score - LOCF Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360952|NCT01668797|Other Pre-specified|Mean Change From Baseline in Personal and Social Performance (PSP) Scale Score - MMRM Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1361167|NCT01667029|Secondary|Breakthrough Treatment (First Treatment Period Only)|Number of days breakthrough pain medication was taken|Assessed during two week treatment period||||days||Standard Deviation|Mean
1361381|NCT01664247|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1360953|NCT01668797|Other Pre-specified|Clinical Global Impression - Improvement Score (CGI-I) at Endpoint - LOCF Analysis|The rater or investigator would rate the participant's total improvement whether or not it is due entirely to study treatment. During Phase B, responses were compared to the participant's condition at Baseline of Phase B (for participants who entered Phase B directly after screening) or to the End of Phase A visit (for participants who participated in Phase A). During Phase C, responses were compared to the participant's condition at the End of Phase B visit. Response choices include: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse.|Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Deviation|Mean
1360954|NCT01668797|Other Pre-specified|Change From Baseline in CGI-S Score at Endpoint - LOCF Analysis|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360955|NCT01668797|Other Pre-specified|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint - MMRM Analysis|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360956|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - LOCF Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360957|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360958|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - LOCF Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360959|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - MMRM Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1361997|NCT01660672|Secondary|Range of Plasma Concentration of LVT Across All Individuals|Range of plasma LVT concentrations will be determined through HPLC method at eight timepoints post administration to evaluate LVT absorption and elimination in pediatric CM.|72 hours||||mcg/ml||Full Range|Mean
1360960|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Total Score - Last-observation-carried-forward (LOCF) Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
1360961|NCT01668797|Other Pre-specified|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
1360962|NCT01668797|Other Pre-specified|Percentage of Participants Meeting Stability Criteria in Double Blind Maintenance Phase|Participants were assessed for stability using the following criteria:1) Outpatient status AND 2) Positive and Negative Syndrome Scale (PANSS) Total Score ≤ 70 AND 3) A score of ≤ 4 (moderate) on each of the following PANSS items (possible scores of 1 to 7 for each item): conceptual disorganization, suspiciousness hallucinatory behavior, unusual thought content, AND 4) Clinical Global Impression - Severity of Illness scale(CGI-S) score ≤ 4 (moderately ill) AND 5) No current suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), defined as the following: An answer of “no” to each question on the Suicidal Behavior section of the C-SSRS AND an answer of “no” to Questions 4 and 5 on the Suicidal Ideation section of the C-SSRS, if completed, AND 6) No evidence of aggressive or violent behavior resulting in clinically significant self-injury, injury to another person, property damage.|Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||percentage of participants|||Number
1360963|NCT01668797|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria in the Double-blind Maintenance Phase|"Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual though content) to a score of >4 and an absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Current suicidal behavior as assessed by the C-SSRS (ie, an answer of yes to any of the questions on the suicidal behavior section of the C-SSRS 5) Violent or aggressive behavior resulting in clinically significant self-injury to another person, or property damage."|Baseline and Week 52/Early Termination|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||percentage of participants|||Number
1360964|NCT01668797|Primary|Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C.|The primary efficacy variable was time to impending relapse from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score >4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content).OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.The measure type, number is Hazard Ratio.|From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks|Based on the Intent-to-Treat (ITT) principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Days||95% Confidence Interval|Number
1360965|NCT01668784|Secondary|Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units|Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: < 8.0 g/dL), Platelet Count (Gr 3: 25.0 -< 50.0*10^9 c/L; Gr 4: < 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -< 2.0*10^3 c/µL; Gr4: < 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -< 0.5*10^3 c/µL; Gr 4: < 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - < 1.0*10^3 c/µL; Gr 4: < 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), AST (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), ALT (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), tBIL (Gr 3: > 3.0 - 10.0 mg/dL * ULN; Gr 4: > 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: > 3.0 - 6.0 mg/dL *ULN; Gr4: > 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus and at least one measureable on-treatment measurement of the corresponding laboratory parameter|||participants|||Number
1360966|NCT01668784|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests at Primary Endpoint|Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants who received at least one dose of nivolumab or everolimus and had at least one measureable on-treatment measurement of the corresponding laboratory parameters|||participants|||Number
1360967|NCT01668784|Secondary|Percentage of Participants With Disease-related Symptom Progression (DRSP) at Primary Endpoint|Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
1360968|NCT01668784|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events at Primary Endpoint|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day of first dose to 30 days post final dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus|||participants|||Number
1360969|NCT01668784|Secondary|Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level at Primary Endpoint|Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&E process before the tumor biopsy specimen was sent for evaluation or from H&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.|Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)|PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline|||months||95% Confidence Interval|Median
1360970|NCT01668784|Secondary|Investigator-assessed Time of Progression-free Survival (PFS) at Primary Endpoint|PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: >=20% increase in sum of target lesion diameters and sum must show absolute increase of >=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
1360971|NCT01668784|Secondary|Investigator-assessed Time to Objective Response at Primary Endpoint|Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.|Randomization to date of first response, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.|||months||Full Range|Median
1360972|NCT01668784|Secondary|Investigator-assessed Duration of Objective Response at Primary Endpoint|Duration of objective response is defined as the time from first response (complete response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.|From date of first response to date of disease progression or death or censoring if no progression or death occurred, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that were randomized to any treatment group in the study and that had a response.|||months||95% Confidence Interval|Median
1361264|NCT01665599|Primary|The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|Day 90|Full Analysis set (FAS) population was used which comprised of subjects who had any available pharmacokinetic (PK) data for testosterone on Day 90.|||percentage of participants|||Number
1360973|NCT01668784|Secondary|Investigator-assessed Objective Response Rate (ORR) at Primary Endpoint|ORR=number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.|At 8 weeks post randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
1360974|NCT01668784|Primary|Overall Survival (OS) at Primary Endpoint|"Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p < 0.0148) was crossed while no new safety signals that would affect continuation of the study were found.~The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria."|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
1360975|NCT01668667|Secondary|The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment||12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||percentage of participants|||Number
1360976|NCT01668667|Secondary|The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~This model only includes treatment in the model. Least squares mean is used for analysis."|Baseline, 12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||units on a scale||Standard Error|Least Squares Mean
1360977|NCT01668667|Primary|The Proportion of Subjects at the End of Treatment Who Are Responders With Either “Much Improved” or “Very Much Improved” on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|12 weeks|mITT (modified intent to treat) population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||percentage of participants|||Number
1360978|NCT01668667|Primary|The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~Change from Baseline = LOCF value at current visit – value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.~The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate."|Baseline, 12 weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||units on a scale||Standard Error|Mean
1360979|NCT01668654|Secondary|Apparent Clearance (CL/F) Following Oral Administration of Retigabine/Ezogabine at Indicated Time Points|Blood samples for population pharmacokinetic analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. CL/F, where CL is the calculated as dose/AUC and F is the oral bioavailability of the drug. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled|Eligbility Assessment (Visit 1), up to 178 days|All Subjects Population||||||
1360980|NCT01668654|Secondary|Area Under the Plasma Concentration-time Curve (AUC) Following Oral Administration of Retigabine/Ezogabine at the Indicated Time Points|AUC is defined as the area under the plasma drug concentration-time curve, reflects the actual body exposure to drug after administration of a dose of the drug and is expressed in milligram*hour per Liter (mg*h/L). Blood samples for population PK analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360999|NCT01668654|Primary|Change From Baseline in Thyroid Stimulating Hormone (TSH) and Urine Albumin Measurements at the Indicated Time Points|Clinical laboratory assessments included measurements of endocrine and urinalysis parameters. TSH and urine albumin parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1360981|NCT01668654|Secondary|Change From Baseline in Child Health Status as Measured by the Child Health Questionnaire (CHQ) in Participants <18 Years Old at the Indicated Time Points|The CHQ comprises scales specifically developed for children and adolescents aged five years and older. The CHQ assesses a child's physical, emotional, and social well-being from the perspective of a parent or guardian. The questionnaire was completed by a parent/caregiver and administration time was approximately 30 minutes. The parent/caregiver completed this questionnaire while the participant was within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibilty Assessment (Visit 1), EW Visit and FU Visit (up to 178 days)|All Subjects Population||||||
1360982|NCT01668654|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI-Improvement (CGI-I) scale which rated the change from Baseline. The CGI-S was a 7-point scale that required the investigator to rate the severity of the participant’s epilepsy relative to the investigator’s past experience with other participants with the same diagnosis. The CGI-S scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=normal, 2=borderline, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360983|NCT01668654|Secondary|Clinical Global Impression- Improvement (CGI-I) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI- Improvement (CGI-I) scale which rated the change from Baseline. The CGI-I scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360984|NCT01668654|Secondary|Number of Participants Who Were Responders During the Treatment Period|A ''responder'' is defined as >50% reduction from Baseline in the seizure frequency. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360985|NCT01668654|Secondary|Percent Change From Baseline in the Seizure Frequency at the Indicated Time Points|The percentage reduction from Baseline in the seizure frequency was summarized using descriptive statistics. The frequencies and percentages were computed for a reduction in seizure frequency of >50% as well as for a 100% reduction (seizure-free). Increases of >50% in seizure frequency was also summarized. The percentage of seizure-free days wasere also analyzed. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Basline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360986|NCT01668654|Primary|Number of Days of Exposure to Retigabine/Ezogabine TID by Individual Participant|Total number of days each participant was exposed to Retigabine/Ezogabine are recorded here.|Treatment Phase plus Taper Phase (up to 97 days)|All Subjects Population|||Days|||Number
1360987|NCT01668654|Primary|Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study|The number of participants who advanced a stage between the eligibility visit and the EW Visit was recorded. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs. The investigator assessed the participant's sexual development in participants <18 years old based on the Tanner Stages of Puberty.|Eligibility Assessment (Visit 1) and EW Visit|All Subjects Population|||Participants|||Number
1360988|NCT01668654|Primary|Changes From Baseline in Learning as Measured by the Wide Range Assessment of Memory and Learning , 2nd Edition (WRAML2) at the Indicated Time Points|The WRAML2 is a standardized test that measures an individual’s memory functioning. It evaluates both visual and verbal, immediate and delayed memory ability along with the acquisition of new learning. The WRAML2 core battery is composed of two verbal, two visual, and two attention concentration subtests, yielding a verbal memory index, a visual memory index and an attention-concentration index. Together, these tests yield the general memory index. The administration time is approximately 40 minutes. During the study, this test was administered if the participant was within the age range (i.e. >9 years). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure Baseline cognition, behavior, and learning so changes from Baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360989|NCT01668654|Primary|Changes From Baseline in Behaviour as Measured by the Child Behavior Checklist (CBCL) at the Indicated Time Points|The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The checklist is comprised of a number of statements about the child's behavior, e.g. acts too young for his/her age. Responses were recorded on a likert scale: 0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true. The preschool checklist contained 100 questions and the school-age checklist contained 120 questions. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360990|NCT01668654|Primary|Changes From Baseline in Cognition as Measured by the Leiter-R at the Indicated Time Points|he Leiter International Performance Scale or simply Leiter is an intelligence test for children and adolescents, with norms ranging from 2 to 20 years. For all ages, it yields an intelligence quotient (IQ) and a measure of logical ability. It is comprised of ten subtests, seven of which were relevant to the 12-18 years age group. The administration time was approximately 40 minutes. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <20 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
1360991|NCT01668654|Primary|Changes From Baseline in Bladder Volume as Assessed by the Post Void Residual (PVR) Ultrasound at the Indicated Time Points|The PVR urine test measured the amount of urine left in the bladder after urination. The PVR bladder ultrasound was performed by an urologist, a qualified technician or by an appropriately trained qualified study nurse at Visits 1, 6, and the EW Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 6, EW Visit|All Subjects Population||||||
1360992|NCT01668654|Primary|Number of Partcipants With Hematology, Chemistry and Urinalysis Parameters Outside the Normal Ranges and Pre-determined Clinically Important Ranges|Clinical laboratory assessment included hematology, chemistry and urinalysis parameters. Clinical laboratory parameters were measured at Visit 1, 4, 5, 6, 7, EW and FU Visit. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1360993|NCT01668654|Primary|Change From Baseline in the Red Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. The red blood cell count was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1360994|NCT01668654|Primary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle hemoglobin was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1360995|NCT01668654|Primary|Change From Baseline in the Mean Corpuscle Volume and Mean Platelet Volume Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle volume and mean platelet colume parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1360996|NCT01668654|Primary|Change From Baseline in the Hematocrit Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Hematocrit was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1360997|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and Red Cell Distribution Width (RDW) Percentages at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, total neutrophils and red cell distribution width (RDW) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1360998|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and White Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils (Total absolute neutrophil count- total ANC), and white blood cell count parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361000|NCT01668654|Primary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid, and Urine Creatinine Concentration Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Creatinine, direct bilirubin, indirect bilirubin, total bilirubin, uric acid, and urine creatinine concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361001|NCT01668654|Primary|Change From Baseline in Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorus, Potassium, Sodium, and Urea/BUN Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Calcium, carbon dioxide content/bicarbonate, chloride, cholesterol, glucose, magnesium, inorganic phosphorus, potassium, sodium, and urea/BUN parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361002|NCT01668654|Primary|Change From Baseline in the BUN/Creatinine and the Urine Albumin/Creatinine Ratios at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Blood Urea Nitrogen (BUN)/Creatinine and Urine Albumin/Creatinine were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361003|NCT01668654|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Albumin, total protein, hemoglobin, and mean corpuscle hemoglobin concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361004|NCT01668654|Primary|Change From Baseline in ALT, ALP, AST, CK, and LDH Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Alanine amino transferase (ALT), alkaline phosphotase (ALP), aspartate amino transferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361005|NCT01668654|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings Based on Investigator Judgment at Anytime During the Study|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visit andthe EW Visit after having kept a participant at rest in this position for 10 minutes. Abnormal findings were analyzed as clinically significant (CS) and not clinically significant (NCS). The study investigator judged the ECG abnormailities as CS or NCS.|Eligibility Assessment and EW Visit|All Subjects Population|||Participants|||Number
1361006|NCT01668654|Primary|Change From Baseline in Electrocardiogram (ECG) at the Indicated Time Points|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visitand the EW Visit after having kept a participant at rest in this position for 10 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days)|All Subjects Population||||||
1361007|NCT01668654|Primary|Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points|BMI is calculated as weight in kilograms (kg) divided by the square of their height in metres (m^2). BMI was measured at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361008|NCT01668654|Primary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361265|NCT01665508|Secondary|Peak O2 Pulse|peak O2 pulse as measured by cardiopulmonary exercise testing|3 months||||ml/beat||Standard Deviation|Mean
1361009|NCT01668654|Primary|Change From Baseline in Body Height at Indicated Time Points|Body height was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361010|NCT01668654|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Vital sign assessment included body temperature measurements at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361011|NCT01668654|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign assessment included heart rate measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361012|NCT01668654|Primary|Change From Baseline in SBP and DBP at the Indicated Time Points|Vital sign assessment included SBP and DBP measurements. SBP and DBP were measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
1361013|NCT01668654|Primary|Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study|Vital sign assessment included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements. SBP, DBP and heart rate were measured at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit after the participants were in the seated position for 5 minutes.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||Participants|||Number
1361014|NCT01668654|Primary|Number of Participants With AEs Leading to Withdrawal|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of the Follow-Up Visit (up to 178 days)|All Subjects Population|||Participants|||Number
1361015|NCT01668654|Primary|Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of Follow-Up (up to 178 days)|All Subjects Population: all participants who enrolled in the study.|||Participants|||Number
1361016|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients|Quality of life was measured via scores of KDQOL SF1.3. Hydration status was measured via body composition monitor as an Overhydration (OH) value Depression was assessed using Beck depression inventory (BDI) score|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1361017|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients|"Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.~Health-related quality of life (HRQOL) is measured via scores of KDQOL SF1.3. Depression was assessed using Beck Depression Inventory (BDI) score. Visit 2 period is followed 12 months after Visit 1 period. HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.~Physical health score, mental health score and kidney disease health score are averaged scores of subscales.~The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.~The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms.~The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1361266|NCT01665508|Secondary|Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing|Assessment of peak heart rate as determined by CPET|3 months||||beats per minute||Standard Deviation|Mean
1361018|NCT01668628|Primary|Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period|"Health-related quality of life (HRQOL) is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period.~KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.~Visit 2 period is followed 12 months after Visit 1 period. The outcome measure is the difference in averaged scores between Visit 1 and Visit 2; It is calculated as (Score at visit 2 - Score at visit 1).~HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.~Physical health score, mental health score and kidney disease health score are averaged scores of subscales.~The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.~The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation.|||units on a scale||Standard Deviation|Mean
1361019|NCT01668589|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.|||percent change||Standard Deviation|Mean
1361020|NCT01668589|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same body side and machine type.|||percent change||Standard Deviation|Mean
1361021|NCT01668589|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.|||percent change||Standard Deviation|Mean
1361022|NCT01668589|Secondary|Percentage of Participants Who Received Denosumab Injections Within the Specified Window|The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.|24 months|Full analysis set|||percentage of participants|||Number
1361023|NCT01668589|Secondary|Time to Non-persistence With Denosumab Injection|Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.|24 months|Full analysis set who were non-persistent at 24 months|||months||Inter-Quartile Range|Median
1361024|NCT01668589|Primary|Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months|"MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.~MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.~It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%."|From baseline to 12 months and 24 months|Full analysis set|||percentage of days of coverage||95% Confidence Interval|Mean
1361025|NCT01668589|Primary|Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months|"A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).~A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart)."|12 months and 24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1361026|NCT01668589|Primary|Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months|"A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).~A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart)."|12 months and 24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1361027|NCT01668173|Primary|Overall Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||participant with Stable Disease|||Number
1361028|NCT01668030|Primary|Time to Wound Epithelialization|Time it required the subjects treated with two standard ointments to establish a wound bed.|Two years||||days|cheeks (side of face)||Number
1361037|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Pimasertib on Cycle 1 Day 15|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||liters||Geometric Coefficient of Variation|Geometric Mean
1361029|NCT01668017|Secondary|Percentage of Subjects With Disease Control|Percentage of subjects with disease control (CR plus PR plus greater than 12 weeks SD) according to RECIST Version 1.1 was reported CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.|||percentage of subjects|||Number
1361030|NCT01668017|Secondary|Percentage of Subjects With Objective Response|Percentage of subjects with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set’ included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.|||percentage of subjects|||Number
1361031|NCT01668017|Secondary|Percentage of Subjects With Best Overall Response|Percentage of subjects with best overall response in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.|||percentage of subjects|||Number
1361032|NCT01668017|Secondary|Accumulation Ratio for Cmax Racc(Cmax) of Part 1: Pimasertib 30 mg In HCC Arm|Racc (Cmax) was calculated as, maximum observed plasma concentration on Day 1 (Cmax) divided by maximum observed plasma concentration on Day 15 (Cmax).|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ratio|||Number
1361033|NCT01668017|Secondary|Accumulation Ratio for Cmax Racc(Cmax) of Pimasertib|Racc (Cmax) was calculated as, maximum observed plasma concentration on Day 1 (Cmax) divided by maximum observed plasma concentration on Day 15 (Cmax). Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1361034|NCT01668017|Secondary|Accumulation Ratio for AUC Racc(AUC) of Part 1: Pimasertib 30 mg In HCC Arm|Racc (AUC) was calculated as, area under the curve from time zero to end of dosing interval on Day 1 divided by area under the curve from time zero to end of dosing interval on Day 15.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ratio|||Number
1361035|NCT01668017|Secondary|Accumulation Ratio for AUC Racc(AUC) of Pimasertib|Racc (AUC) was calculated as, area under the curve from time zero to end of dosing interval on Day 1 divided by area under the curve from time zero to end of dosing interval on Day 15. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1361036|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||liters|||Number
1361131|NCT01667471|Secondary|Number of Joints With Lack of Motion|Joints with lack of movement were assessed. The maximum number of joints with lack of movement was 67. The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant’s efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||joints||Standard Deviation|Mean
1361038|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||liters|||Number
1361039|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Pimasertib on Cycle 1 Day 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||liters||Geometric Coefficient of Variation|Geometric Mean
1361040|NCT01668017|Secondary|Apparent Clearance at Steady-state (CLss/f) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Apparent clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||L/h|||Number
1361041|NCT01668017|Secondary|Apparent Clearance at Steady-state (CLss/f) of Pimasertib on Cycle 1 Day 15|Apparent clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1361042|NCT01668017|Secondary|Apparent Clearance (CL/f) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||L/h|||Number
1361043|NCT01668017|Secondary|Apparent Clearance (CL/f) of Pimasertib on Cycle 1 Day 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1361044|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
1361045|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib on Cycle 1 Day 15|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
1361046|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
1361047|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib on Cycle 1 Day 1|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
1361267|NCT01665508|Secondary|Exercise Duration|Assessment of exercise duration as determined by CPET|3 months||||minutes||Standard Deviation|Mean
1361048|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL|||Number
1361049|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib at Cycle 1 Day 15|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361050|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib of 1 Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL|||Number
1361051|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib at Cycle 1 Day 1|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours).|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361052|NCT01668017|Secondary|Area Under the Concentration Over Time (AUCt) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL|||Number
1361053|NCT01668017|Secondary|Area Under the Concentration Over Time (AUCt) at Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361054|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
1361055|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 15|Data were not reported for “Part 1: Pimasertib 45 mg In HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
1361056|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
1361057|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours||Full Range|Median
1361058|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ng/mL|||Number
1361059|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 15|Data were not reported for “Part 1: Pimasertib 45 mg in HCC” arm as there were no PK samples collected for this arm.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361060|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ng/mL|||Number
1361061|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|Pharmacokinetic (PK) analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1361062|NCT01668017|Secondary|Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 30 days post last dose of study drug; assessed maximum up to 39.4 weeks|Safety analysis set included all subjects who received at least one administration of pimasertib.|||subjects|||Number
1361063|NCT01668017|Primary|Number of Subjects Who Experienced at Least One Dose Limiting Toxicity (DLT)|DLT defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0): any of following toxicities possibly/probably related to study drug: Any non-hematological toxicity of Grade 3 or higher (excluding Grade 3 asymptomatic rise in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT] reversible in 7 days for subjects with solid tumor and without liver involvement, or Grade 4 for subjects with HCC or with liver involvement; Grade 3 or 4 asymptomatic rise in creatinine phosphokinase (CPK) reversible in 7 days, deniable for myocardial infarction and rhabdomyolysis; Grade 3 vomiting/diarrhea encountered without optimal therapy). Any Grade 4 neutropenia >5 days duration, any Grade 3 or above febrile neutropenia. Grade 4 thrombocytopenia >1 day or Grade 3 with bleeding. Any treatment delay >2 weeks due to drug-related adverse effects.|During Treatment Cycle 1 (Day 1 to 21)|DLT analysis set included all subjects who experienced any DLT during Cycle 1 and who received above 85% of all planned doses of pimasertib during Cycle 1.|||subjects|||Number
1361064|NCT01668004|Secondary|Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM|The percentage of participants with ASDAS clinically important improvement (ASDAS-CII; ≥ 1.1 units) and major improvement (ASDAS-MI; ≥ 2.0 units) at 3 months were determined. The ASDAS incorporates three items from the BASDAI (spinal pain, duration of morning stiffness, and peripheral joint pain or swelling) each assessed on a VAS (0 to 10 cm; increasing severity) as well as patient global assessment of disease activity (VAS; 0 to 10 cm; increasing severity) and a laboratory measure of inflammation (CRP level [mg/L] or ESR [mm/hr]). ASDAS was calculated using the formula: 0.12*Spinal Pain + 0.06*Duration of Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*ln(CRP (mg/L) +1). A decrease in ASDAS at 3 months relative to BL signifies an improvement in physical function; ASDAS-MI (≥ 2.0 units decrease from BL) signifies a comparatively greater improvement in physical function than ASDAS-CII (≥ 1.1 units decrease from BL).|BL, Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (ASDAS).|||Percentage of participants|||Number
1361065|NCT01668004|Secondary|Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM|The percentage of participants with a BASDAI 50 response (defined as a 50% improvement or as an absolute improvement of 2 points in their BASDAI physical function score) at three months was determined. The BASDAI consists of total of six visual analog scales (VAS): five VAS (0 to 10 cm; increasing severity) measuring severity of fatigue, spinal pain, peripheral joint pain or swelling, localized tenderness, and severity of morning stiffness and one VAS (0 to 10 cm; increasing duration up to 2 hours) measuring duration of morning stiffness. The morning stiffness scores are averaged and summed with the scores for the remaining four items resulting in a composite score (0-50); the final BASDAI score (0-10) is derived by dividing by 5.|Baseline (BL), Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (BASDAI 50).|||Percentage of participants|||Number
1361066|NCT01668004|Secondary|Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|IBD (Crohn's disease or ulcerative colitis) and psoriaris are extra-articular manifestations of AS involving the intestinal tract and skin, respectively. The annual incidence rates of new-onset or flares of IBD and psoriasis were to be determined separately (i.e., for each condition) over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|The incidence rates for new onset or flares of IBD and psoriasis could not be evaluated due to limitations of the data collected; occurrence of flares was not collected (specifically, history of IBD and/or psoriasis could not be distinguished from flares of IBD and/or psoriasis) and, therefore, results could not be determined.||||||
1362048|NCT01660191|Secondary|Changes to Glucose Metabolism - HbA1c and Insulin|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.|Change from Baseline to 12 weeks||||percentage change from baseline measure||Standard Deviation|Mean
1361067|NCT01668004|Primary|Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|Uveitis is an extra-articular manifestation of AS involving inflammation of the eye. The annual incidence rate of new uveitis attacks was determined over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose. All participants were counted as contributing a full year of GLM exposure even if discontinuing early. Due to ongoing uveitis cases at time of period entry, participants did not have the same risk of new events during the one year periods. Participants with ongoing uveitis at start of GLM who had the adverse event for the entire treatment period were counted as having the 'new attack' before and no “new attack” after GLM treatment start.|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (incidence of uveitis). One participant for whom the timing of uveitis events could not be determined was excluded from the analysis.|||Events per 100 participant years|||Number
1361068|NCT01668004|Primary|Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|Uveitis is an extra-articular manifestation of ankylosing spondylitis (AS) involving inflammation of the eye. The occurrence rate (assessed as present/absent) of uveitis attacks was determined over two 1-year long periods regardless of whether the event started during the assessed year: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (occurence of uveitis).|||Ratio|||Number
1361069|NCT01667978|Primary|AUC Norethindrone|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21|following 21 days of continuous ingestion|2 withdrew because unable to present for study visit and another changed her medication|||ng*h/mL||Full Range|Mean
1361070|NCT01667926|Secondary|HDRS-28 Total|Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.|up to 5 months||||units on a scale||Standard Deviation|Mean
1361071|NCT01667926|Primary|Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)|The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.|up to 4 months||||units on a scale||Standard Deviation|Mean
1361072|NCT01667900|Secondary|Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])|Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.|Baseline and Days 3, 24, and 29|Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.|||millimoles*hours per liter (mmol*h/L)||Standard Deviation|Mean
1361073|NCT01667900|Primary|Pharmacokinetics: Half-life of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.|||hours||Full Range|Geometric Mean
1361074|NCT01667900|Primary|Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1361075|NCT01667900|Primary|Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.|||hours||Full Range|Median
1361076|NCT01667900|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1361077|NCT01667848|Secondary|Core Temperature|core temperature during laparoscopic cholecystectomy using a rectal probe|during operation||||degree celsius||Standard Deviation|Mean
1361078|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.~The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|first postoperative day||||units on a scale 0-10||Standard Deviation|Mean
1361079|NCT01667848|Secondary|Core Temperature||one day postoperativly|||||||
1361080|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.~The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|operation day|||||||
1361081|NCT01667796|Secondary|Gene Expression Microarray|These data have not yet been generated|90 days||2017-03-31|03/2017||||
1361082|NCT01667796|Secondary|Cytokine Levels and Percentages of T and B Cells|These data have not yet been fully analyzed.|90 days||2018-01-31|01/2018||||
1361083|NCT01667796|Primary|Change in Mean Serum Level of 25-hydroxyvitamin D|Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and HCs to take into account repeated measures and within-subject correlations.|Baseline to 90 days||||nmol/L||Standard Deviation|Mean
1361084|NCT01667731|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1361085|NCT01667731|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1361086|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1361087|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1361088|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1361089|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1361090|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1361091|NCT01667731|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1361092|NCT01667731|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1361093|NCT01667731|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
1361094|NCT01667679|Secondary|Number of Participants With the Indicated Concomitant Medications|Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.|up to 24 weeks|Safety Analysis Set|||participants|||Number
1361095|NCT01667679|Secondary|Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set|||participants|||Number
1361096|NCT01667679|Secondary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|"The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of normal or abnormal was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant."|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set|||participants|||Number
1361097|NCT01667679|Secondary|Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||beats per minute||Standard Deviation|Mean
1361098|NCT01667679|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1361099|NCT01667679|Secondary|Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|"The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with 1+, 2+, and 3+ indicating increasing amounts of metabolites in urine."|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set|||participants|||Number
1361100|NCT01667679|Secondary|Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||pH||Standard Deviation|Mean
1361101|NCT01667679|Secondary|Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||mmoles/L||Standard Deviation|Mean
1361102|NCT01667679|Secondary|Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||grams per Liter (grams/L)||Standard Deviation|Mean
1361103|NCT01667679|Secondary|Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||Units per Liter (U/L)||Standard Deviation|Mean
1361104|NCT01667679|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||International Units per Liter (IU/L)||Standard Deviation|Mean
1361105|NCT01667679|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||International Units per Liter (IU/L)||Standard Deviation|Mean
1361106|NCT01667679|Secondary|Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||micromoles per Liter (µmol/L)||Standard Deviation|Mean
1361107|NCT01667679|Secondary|Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1361108|NCT01667679|Secondary|Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||10^9 cells per Liter||Standard Deviation|Mean
1361109|NCT01667679|Secondary|Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||10^12 cells per Liter||Standard Deviation|Mean
1361132|NCT01667471|Secondary|Number of Joints With Active Arthritis|Joints with active arthritis were defined as joints with swelling or pain and limited of motion. The maximum number of joints with active arthritis was 71.The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant’s efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||joints||Standard Deviation|Mean
1361110|NCT01667679|Secondary|Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)|Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||proportion||Standard Deviation|Mean
1361111|NCT01667679|Secondary|Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)|Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||grams per Liter (g/L)||Standard Deviation|Mean
1361112|NCT01667679|Secondary|Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event|An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.|Baseline compared to Vist 2, 3 and 4|Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet|||participants|||Number
1361113|NCT01667679|Secondary|Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose|Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.|||scores on a scale||Standard Error|Least Squares Mean
1361114|NCT01667679|Secondary|Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose|Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.|||scores on a scale||Standard Error|Least Squares Mean
1361115|NCT01667679|Secondary|Median Time to Pain Freedom|Pain freedom is defined as a pain level reduced to none (Grade 0).|120 minutes post-dose (up to 24 weeks)|FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.|||minutes||95% Confidence Interval|Median
1361116|NCT01667679|Secondary|Percentage of Attacks in Which Pain Relief Was Achieved|Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used in this analysis.|||percentage of attacks|number of moderate or severe attacks||Number
1361117|NCT01667679|Secondary|Percentage of Attacks in Which Pain Freedom Was Achieved|Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis.|||percentage of attacks|number of attacks||Number
1361118|NCT01667679|Secondary|Percentage of Attacks in Which Pain Reduction Was Achieved|Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|10, 15, 30, 45, 60, 90, and 120 minutes|FAS. The LOCF imputation method was used in this analysis.|||percentage of attacks|number of attacks||Number
1361119|NCT01667679|Secondary|Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe|"SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of 0 indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis."|Baseline and 30 minutes post-dose (up to 24 weeks)|FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.|||scores on a scale||Standard Error|Least Squares Mean
1361120|NCT01667679|Primary|Mean Sum of Migraine Pain Intensity Differences (SPID)-30|"SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of 0 indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis."|Baseline and 30 minutes post-dose (up to 24 weeks)|Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.|||scores on a scale||Standard Error|Least Squares Mean
1361121|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.|||% sensitivity|||Number
1361122|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.|||% specificity|||Number
1361123|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions|"For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined tissue-segments) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique."|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)|||% sensitivity|Lymph Node Segments|90% Confidence Interval|Number
1361124|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland|For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined “tissue-segments”) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)|||% sensitivity|Prostate Segments|90% Confidence Interval|Number
1361125|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes|For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.|||% sensitivity||90% Confidence Interval|Number
1361126|NCT01667536|Primary|Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.|For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)|||% sensitivity||90% Confidence Interval|Number
1361127|NCT01667471|Secondary|CRP Levels|CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL).|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mg/dL||Standard Deviation|Mean
1361128|NCT01667471|Secondary|Parent or Participant's Assessment of Pain (VAS)|Parents or participants rated participant's pain by placing a horizontal line on a VAS of 0 (no pain)- 100 mm (severe pain).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm||Standard Deviation|Mean
1361129|NCT01667471|Secondary|CHAQ-DI Score|The CHAQ-DI questionnaire consisted of 30 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain had at least two component questions and if applicable to the participant there were four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||score on a scale||Standard Deviation|Mean
1361130|NCT01667471|Secondary|Erythrocyte Sedimentation Rate|ESR is a marker of inflammation and was measured as millimeters per hour (mm/h). Healthy individuals have low ESR. Higher ESR indicate inflammation.|Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm/h||Standard Deviation|Mean
1361133|NCT01667471|Secondary|Parent or Participant's Assessment of Global Activity (VAS)|The participant or parent/guardian, as appropriate, provided a rating of the participant’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line Score 0 represented ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end score 100 represented ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicated poorer well-being.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm||Standard Deviation|Mean
1361134|NCT01667471|Secondary|Physicians Assessment of Global Activity (VAS)|The participant’s treating physician provided a rating of the participant’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line, score 0 represented ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end score 100 represented ‘arthritis very active’. A higher score indicated more disease activity.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm||Standard Deviation|Mean
1361135|NCT01667471|Secondary|Percentage of Participants Achieving Clinical Remission (CR) at Each Visit|"CR was defined as clinical remission with medication (CRem). A participant was in CR if inactive disease was observed for a minimum of 6 consecutive months."|Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
1361136|NCT01667471|Secondary|Percentage of Participants With Inactive Disease by Visit|A participant was defined to show inactive disease if all of the following criteria were applied: 1) No joints with active arthritis (no joints with swelling and no joints with lack of motion), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) Physician's global assessment of disease activity equals (=) 0 millimeters (mm) on a Visual analog scale (VAS).|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
1361137|NCT01667471|Primary|Number of AEs of Special Interest and Study Drug Related AEs|AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab.|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set|||adverse events|||Number
1361138|NCT01667471|Secondary|Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit|"The six JIA ACR components comprised of: 1) Physician's global assessment of disease activity, 2) Parent/Participant's global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP), and 6) Childhood Health Assessment Questionnaire - Disease Index (CHAQ-DI).~At an assessment visit, a JIA ACR30/50/70/90 response in comparison to Baseline was defined as: At least three of the six JIA ACR core components improving by at least 30 percent (%), 50%, 70%, or 90% respectively and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; number (n) = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
1361139|NCT01667471|Primary|Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS).|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set|||participants|||Number
1361140|NCT01667432|Secondary|Safety: Incidence of Adverse Events||approximately 3 years|||||||
1361141|NCT01667432|Primary|In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive||approximately 3 years|||||||
1361142|NCT01667432|Secondary|Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio||approximately 3 years|||||||
1361143|NCT01667432|Secondary|Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years|||||||
1361144|NCT01667432|Secondary|Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years|||||||
1361145|NCT01667432|Secondary|HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative||approximately 3 years|||||||
1361146|NCT01667432|Secondary|Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.|At the end of treatment (Week 24)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1361147|NCT01667432|Primary|Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml||approximately 3 years|||||||
1361148|NCT01667432|Primary|Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).|At the end of the study (Week 36)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.|||Percentage of participants||95% Confidence Interval|Number
1361165|NCT01667029|Secondary|Missed Medication Dose (First Treatment Period Only)|Number of missed medication doses|Assessed during two week treatment period||||dose||Standard Deviation|Mean
1361149|NCT01667250|Secondary|Mean Change in Quality of Life Short Form Survey (SF-12)|"The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8."|Run-in (4 weeks) and Randomized period (8 weeks)|Randomized period|||Score on a scale||Standard Deviation|Mean
1361150|NCT01667250|Secondary|Use of Pain Relief Medication|All abortive headache medication taken during randomized period|Randomized period - 8 weeks|Randomized population|||Participants|||Count of Participants
1361151|NCT01667250|Secondary|Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe|Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe.|Run-in (4 weeks no treatment) and Randomized (8 weeks)|Randomized population|||Headache days|||Number
1361152|NCT01667250|Secondary|Mean Change in Headache Days|Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.|Run-in period (4 weeks no treatment) and Randomized period (8 weeks)|Data missing for 1 subject in each treatment group|||days||Standard Deviation|Mean
1361153|NCT01667250|Primary|Safety - Number of Participants With Adverse Events|Safety was assessed by collecting Adverse Effects|Up to 8 weeks - duration of the Randomized period|Randomized population|||Participants|||Count of Participants
1361154|NCT01667224|Secondary|Changes in Body Mss Index(BMI)|BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)||||kg/m^2||Standard Error|Mean
1361155|NCT01667224|Secondary|Changes in Body Weight.|Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)||||kg||Standard Error|Mean
1361156|NCT01667224|Secondary|Changes in Abdominal Total Fat Area.|Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).|study visit 1(0 week), visit 4(12 week)||||cm^2||Standard Error|Mean
1361157|NCT01667224|Primary|Changes in Body Fat Mass.|Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)||||kg||Standard Error|Mean
1361158|NCT01667107|Secondary|Percentage of Participants Who Develop Invasive Fungal Infection|Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.|Up to Day 84|Participants were analyzed according to the group in which they were enrolled|||Percentage of participants||95% Confidence Interval|Number
1361159|NCT01667107|Primary|Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum|Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.|Up to Day 42|The population analyzed included all enrolled participants who had BAL and serum samples collected at the time of bronchoscopy and analyzed for posaconazole concentration. A participant could have more than 1 pair of samples (BAL and serum) included in the analysis.|||mg/L|paired BAL and serum samples|Standard Deviation|Mean
1361160|NCT01667107|Post-Hoc|Time to Maximum Serum Concentration of Posaconazole (Tmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time required to achieve the maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants|||Days||Standard Deviation|Mean
1361161|NCT01667107|Post-Hoc|Maximum Serum Concentration of Posaconazole (Cmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants|||mg/L||Standard Deviation|Mean
1361162|NCT01667107|Post-Hoc|Time to Reach a Serum Concentration of Posaconazole of >=0.5 mg/L|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. A posaconazole concentration >=0.5 mg/L is the therapeutic level, the concentration thought to lead to antifungal efficacy. The time at which the serum posaconazole concentration reached >=0.5 mg/mL and remained at that level for all subsequent assessments was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants who reached and maintained posaconazole concentration of >=0.5 mg/L|||Days||Standard Deviation|Mean
1361163|NCT01667107|Primary|Time to Reach 90% of the Steady State Serum Concentration of Posaconazole|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population to be analyzed included participants who complied with the protocol sufficiently to ensure that the results would exhibit the effects of treatment||||||
1361164|NCT01667029|Secondary|Missed Medication Doses (Using the Crossover Comparison Structure of the Study)|Number of missed medication doses|Assessed during two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||doses||Standard Deviation|Mean
1361168|NCT01667029|Secondary|Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)|Assessed using number of days rated as none, mild, moderate, or severe in pain diary|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. One participant did not complete the categorical pain data in either period.|||days||Standard Deviation|Mean
1361169|NCT01667029|Secondary|Categorical Rating of Pain Intensity (First Treatment Period Only)|Assessed using number of days rated as none, mild, moderate, or severe in pain diary|Assessed at end of two week treatment period|One participant in the sulfasalazine arm did not complete the categorical pain data.|||days||Standard Deviation|Mean
1361170|NCT01667029|Secondary|Overall Improvement (Using the Crossover Comparison Structure of the Study)|The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.|Will be assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. 2 of the sulfasalzine participants are missing PGIC.|||units on a scale||Standard Deviation|Mean
1361171|NCT01667029|Secondary|Overall Improvement (First Treatment Period Only)|The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.|Will be assessed at end of two week treatment period|2 participants in the sulfasalazine group are missing PGIC information.|||units on a scale||Standard Deviation|Mean
1361172|NCT01667029|Secondary|Emotional Functioning (Using the Crossover Comparison Structure of the Study)|Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||units on a scale||Standard Deviation|Mean
1361173|NCT01667029|Secondary|Emotional Functioning (First Treatment Period Only)|Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.|Assessed at end of two week treatment period||||units on a scale||Standard Deviation|Mean
1361174|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)|The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||Participants|||Count of Participants
1361175|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)|The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1|||units on a scale||Standard Deviation|Mean
1361176|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)|The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).|Assessed at end of two week treatment period||||Participants|||Count of Participants
1361177|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)|The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).|Assessed at end of two week treatment period||||units on a scale||Standard Deviation|Mean
1361193|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng*hr/mL||Standard Deviation|Mean
1389684|NCT01361126|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP||Pre-dose and up to 14 days after infusion|PK population|||hours||Geometric Coefficient of Variation|Geometric Mean
1361178|NCT01667029|Secondary|Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during baseline and the second week of each of the two week treatment periods. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks) and from end of treatment period 1 to end of treatment period 2 (2 weeks), based on average pain scores at each time point.|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||Participants|||Count of Participants
1361179|NCT01667029|Secondary|Number of Patients With >=50% Pain Reduction (First Treatment Period)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary at baseline and during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks), based on average pain scores at each time point.|second week of two week treatment period||||Participants|||Count of Participants
1361180|NCT01667029|Secondary|Pain Score (Using the Crossover Comparison Structure of the Study)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||units on a scale||Standard Deviation|Mean
1361181|NCT01667029|Primary|Pain Score (First Treatment Period)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).|second week of two week treatment period||||units on a scale||Standard Deviation|Mean
1361182|NCT01666951|Other Pre-specified|Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.|The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.|30 days||||participants|||Number
1361183|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||ratio||Standard Deviation|Mean
1361184|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||ratio||Standard Deviation|Mean
1361185|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||Percentage of fluctuation||Standard Deviation|Mean
1361186|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||Percentage of fluctuation||Standard Deviation|Mean
1361187|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||hour||Standard Deviation|Mean
1361188|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||hour||Standard Deviation|Mean
1361189|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||hour||Standard Deviation|Mean
1361190|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng/mL||Standard Deviation|Mean
1361191|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng/mL||Standard Deviation|Mean
1361192|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng/mL||Standard Deviation|Mean
1361681|NCT01662908|Secondary|Number of Participants With Recurrence of Venous Thromboembolism (VTE)|Number of participants with investigator-confirmed recurrent VTE events that start or worsen after the first dose of study drug and prior to the date of the final visit or telephone contact (inclusive)|Baseline to final visit (Day 14-21)|mITT|||Participants|||Count of Participants
1361194|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng*hr/mL||Standard Deviation|Mean
1361195|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng*hr/mL||Standard Deviation|Mean
1361196|NCT01666951|Other Pre-specified|Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Day 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||mmHg||Standard Deviation|Mean
1361197|NCT01666951|Other Pre-specified|Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||mmHg||Standard Deviation|Mean
1361198|NCT01666912|Secondary|Rapid Repeat Pregnancy|To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.|12 months||||participants||95% Confidence Interval|Number
1361199|NCT01666912|Secondary|Satisfaction|"To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being not satisfied at all to 10 being extremely satisfied."|12 months||||units on a scale||Standard Deviation|Mean
1361200|NCT01666912|Primary|Continuation at 1 Year|The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.|12-14 months||||participants|||Number
1361201|NCT01666782|Secondary|Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.|Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine|28 days||||participants|||Number
1361202|NCT01666782|Secondary|Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.|Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days||||participants|||Number
1361203|NCT01666782|Secondary|Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.|Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days||||participants|||Number
1361204|NCT01666782|Secondary|The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.|Baseline and 28 days||||percentage of participants|||Number
1361205|NCT01666782|Secondary|The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.|28 days||||percentage of participants|||Number
1361206|NCT01666782|Primary|The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.|Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.|Baseline and 28 days||||titers||95% Confidence Interval|Geometric Mean
1361207|NCT01666314|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years|Safety Population included all randomized participants who received at least one dose of study drug. Adverse events are summarized as per the treatment received.|||participants|||Number
1361208|NCT01666314|Secondary|Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite|Observed predose plasma concentration at steady state.|Cycle 1 Day 8 Predose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361209|NCT01666314|Secondary|Rac: Accumulation Index for Orteronel and M-I Metabolite|Rac was calculated as the ratio of AUCtau to AUC12hr.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1361210|NCT01666314|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361682|NCT01662908|Secondary|Number of Participants With Clinically Relevant Bleeding|Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding|Initial dose of study drug up to 3 days after last dose|Adjudicated in the mITT population|||Participants|||Count of Participants
1361211|NCT01666314|Secondary|Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||hours||95% Confidence Interval|Median
1361212|NCT01666314|Secondary|Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite|Maximum observed steady-state plasma concentration during a dosing interval.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361213|NCT01666314|Secondary|AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite|Cumulative amount of urine excreted time 0 to 24 hour.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||mg||Geometric Coefficient of Variation|Geometric Mean
1361214|NCT01666314|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||hours||Full Range|Median
1361215|NCT01666314|Secondary|AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite|AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361216|NCT01666314|Secondary|Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361217|NCT01666314|Secondary|Absolute Values for Prostate-Specific Antigen (PSA)|Serum PSA was measured at the central laboratory.|Baseline and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||ng/mL||Standard Deviation|Mean
1361218|NCT01666314|Secondary|Absolute Values for Cortisol|Serum Cortisol was measured by immunometric assay at the central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||nmol/L||Standard Deviation|Mean
1361219|NCT01666314|Secondary|Absolute Values for Corticosterone|Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||nmol/L||Standard Deviation|Mean
1361220|NCT01666314|Secondary|Absolute Values for Adrenocorticotropic Hormone (ACTH)|Serum ACTH was measured by immunometric assay at the central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||pmol/L||Standard Deviation|Mean
1361221|NCT01666314|Secondary|Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)|Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||nmol/L||Standard Deviation|Mean
1361222|NCT01666314|Secondary|Absolute Values for Testosterone|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||ng/dL||Standard Deviation|Mean
1361223|NCT01666314|Secondary|Percentage of Participants With PSA50 After 12 Weeks of Treatment|A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.|Baseline and Week 12|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.|||percentage of participants||95% Confidence Interval|Number
1361224|NCT01666314|Secondary|Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment|A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.|Baseline and Week 4|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.|||percentage of participants||95% Confidence Interval|Number
1361225|NCT01666314|Secondary|Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 12|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.|||percent change||Standard Deviation|Mean
1361226|NCT01666314|Secondary|Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 4|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.|||percent change||Standard Deviation|Mean
1361227|NCT01666314|Secondary|Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 4|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||percentage of participants||95% Confidence Interval|Number
1361228|NCT01666314|Primary|Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 4|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||percentage of participants||95% Confidence Interval|Number
1361229|NCT01666210|Other Pre-specified|Adverse Events|Measure of adverse events over the duration of each subject's participation in the study.|Duration of each individual subject's participation in the study|Ocular adverse events|||percentage of participants|||Number
1361230|NCT01666210|Primary|Absence of Pain in the Study Eye||Day 8||||Participants|||Count of Participants
1361231|NCT01666210|Primary|Absence of Cells in Anterior Chamber of Study Eye||Day 8||||percentage of participants|||Number
1361232|NCT01666197|Primary|Pain on Movement|"Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|48 hours||||mm||Standard Deviation|Mean
1361233|NCT01666145|Secondary|Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)|A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below.|Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.||||percentage of participants|||Number
1361234|NCT01666145|Primary|Successful Insertion of Ablation Antenna Into Target Lesion|Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.|Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.||||percentage of participants|||Number
1361235|NCT01666119|Primary|Adverse Events|Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported.|12 weeks|All subjects who received at least 1 dose of study drug.|||adverse events|||Number
1361236|NCT01666119|Secondary|Urine Drug Screen|Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.|12 weeks|Subjects with at least one urine drug screen test during the treatment period.|||participants|||Number
1361237|NCT01666002|Secondary|Proximal Clearance of Fungus on Nail|The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients’ toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.|1 year||||mm|Participants|Standard Deviation|Mean
1361238|NCT01666002|Primary|The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.||1 year||||percentage of participants|||Number
1361239|NCT01665950|Primary|Change in MADRS (4 Weeks)|Change in Montgomery-Asberg Depression Rating Scale (MADRS) in simvastatin-treated epochs versus placebo-treated epochs|Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4)||||units on a scale|||Number
1361240|NCT01665911|Secondary|Enamel Fluoride Uptake Per Each of Five Arms|Enamel fluoride uptake is a measure of fluoridation of a caries lesion|Three Weeks per each of five arms||||microgram fluoride per square cm||Standard Error|Least Squares Mean
1361241|NCT01665911|Secondary|% Acid Resistance Score Per Each of Five Arms|% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.|Three Weeks per each of five arms||||percent||Standard Error|Least Squares Mean
1361242|NCT01665911|Primary|% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms|"surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:~SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening)."|Three Weeks per each of five arms||||percent||Standard Error|Least Squares Mean
1361243|NCT01665807|Secondary|Pain at Injection Site|Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8)|Follow up (Day 8|||||||
1361244|NCT01665807|Secondary|Local & Systemic Reactogenicity|Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination|Follow up (Day 8)|||||||
1361245|NCT01665807|Secondary|Success Rate|Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.|Vaccination (Day 0)||||participants|||Number
1361246|NCT01665807|Secondary|Acceptability of Vaccine|The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination.|Follow up (Day 8)|||||||
1361247|NCT01665807|Primary|Time to Administer Influenza Vaccine (in Seconds)|Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination|Vaccination (Day 0)||||seconds||Full Range|Median
1361263|NCT01665599|Secondary|The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|Day 1|FAS population was used which comprised of subjects who had any available PK data for testosterone on Day 90.|||percentage of participants|||Number
1362049|NCT01660191|Secondary|Changes in Major Lipid Parameters - VLDL Size|Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.|Change from Baseline to 12 Weeks||||nanometre (nm)||Standard Deviation|Mean
1361248|NCT01665599|Secondary|Change From Baseline in the SF-12 Health Questionnaire|"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:~PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)~MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)~The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0–100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and standard deviation of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~The data were presented using descriptive statistics."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.|||units on a scale||Standard Deviation|Mean
1361249|NCT01665599|Secondary|Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire|"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).~The data were presented using descriptive statistics."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.|||units on a scale||Standard Deviation|Mean
1361250|NCT01665599|Secondary|Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire|"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:~Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.|||units on a scale||Standard Deviation|Mean
1361251|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Tmin|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
1361252|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cmin|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
1361253|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cave|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
1361254|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cmax|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
1361255|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Tmax|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
1361256|NCT01665599|Secondary|Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng*hr/dL||Standard Deviation|Mean
1361257|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
1361258|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
1361259|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
1361260|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
1361261|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
1361262|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)|A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng*hr/dL||Standard Deviation|Mean
1362050|NCT01660191|Primary|Changes in Plasma CoQ10 Levels|Change in levels will be measured by taking difference between Baseline and Week 12 measures.|Change from Baseline to 12 Weeks||||μg/g||Standard Deviation|Mean
1361268|NCT01665508|Secondary|SF36|The SF-36v2 is a commonly used instrument to assess HRQoL8. The questionnaire evaluates 8 HRQoL domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The physical component score is a composite of the SF-36v2 physical health domains (physical functioning, role-physical, bodily pain and general health) and the mental component score a composite of the mental health domains (vitality, social functioning, role-emotional and mental health). Each HRQoL domain score ranges from 0 to 100, with higher scores corresponding to a better health status. The SF-36v2 domain scores were calculated using the QualityMetric Health Outcomes Scoring Software version 4.5.|baseline and 12 week follow-up|physical functioning reported below|||units on a scale||Standard Deviation|Mean
1361269|NCT01665508|Secondary|Resource Utilization Questionnaire|Resource utilization as determined by patient phone calls, office visits, emergency room visits, and number of hospitalizations, as well an index cost for any hospitalizations|3 months|data was not collected||||||
1361270|NCT01665508|Secondary|Peak VO2 Measured by Cardiopulmonary Exercise Testing|Assessment of exercise capacity (peak VO2) as determined by CPET|3 months||||ml/beat||Standard Deviation|Mean
1361271|NCT01665508|Primary|Seattle Angina Questionnaire Score|"Seattle Angina Questionnaire (SAQ):~The SAQ is a 5 part survey that is widely used and well validated tool to assess angina stability and angina frequency among patients with coronary artery disease.~The SAQ is a validated, self-administered 19-item questionnaire with 5 different dimensions of health status in patients with CAD including: angina frequency, angina stability, disease-specific quality of life, physical limitations and treatment satisfaction. Each SAQ domain score ranges from 0-100, with higher scores indicating a better health status."|3 months|7 patients complete baseline and followup data reported below is anginal stability|||units on a scale||Standard Deviation|Mean
1361272|NCT01665430|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores from all questions and ranged from 0 to 3, where higher scores represented higher disease activity. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from study for reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
1361273|NCT01665430|Secondary|Change From Baseline in Participant Assessment of Pain Using VAS|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 mm (no pain) to 100 mm (unbearable pain). Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with “Unspecified” reason of discontinuation were excluded for change from baseline analysis.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||mm||Standard Deviation|Mean
1361274|NCT01665430|Secondary|Change From Baseline in PtGA of Disease Activity Using VAS|The PtGA of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, and was described as “maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicated improvement. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with “Unspecified” reason of discontinuation were excluded for change from baseline analysis.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||mm||Standard Deviation|Mean
1361275|NCT01665430|Secondary|Change From Baseline in Physician’s Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)|"The PGA of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, and was described as “maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicated improvement. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||mm||Standard Deviation|Mean
1361284|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Standing - 6. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
1368803|NCT01581710|Primary|Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)|Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
1361276|NCT01665430|Secondary|Time to Rheumatoid Arthritis (RA) Flare in Participants Who Had Entered Drug-Free Remission|Time to RA flare was defined as the period of drug-free remission (having DAS28-ESR score <2.6 for 2 consecutive assessment visits followed by discontinuation of tocilizumab at the second assessment visit) until documented RA flare. RA flare was defined as any worsening of the participant’s disease activity that, in the opinion of the Investigator, required treatment intensification beyond supportive therapy which could include restarting the study drug.|Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])|The time to RA flare could not be evaluated as none of the participants showed drug-free remission.||||||
1361277|NCT01665430|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as having DAS28-ESR score <2.6 at any point during the study. DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, ESR, (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment on a 0 to 100 mm VAS; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity.|Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])|ITT population|||percentage of participants|||Number
1361278|NCT01665430|Secondary|Percentage of Participants With Drug-Free Remission|Drug-free remission was defined as having clinical remission (defined as DAS28-ESR score <2.6) for 2 consecutive assessment visits followed by discontinuation of tocilizumab at the second assessment visit. DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, ESR, (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment on a 0 to 100 mm VAS; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity.|Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])|ITT population|||percentage of participants|||Number
1361279|NCT01665430|Secondary|Change From Baseline in Total Swollen Joint Counts (28 Joints)|"The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count of 0 to 28. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||swollen joints||Standard Deviation|Mean
1361280|NCT01665430|Secondary|Change From Baseline in Total Tender Joint Counts (28 Joints)|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count of 0 to 28. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with “Unspecified” reason of discontinuation were excluded for change from baseline analysis.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||tender joints||Standard Deviation|Mean
1361281|NCT01665430|Secondary|Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score|DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, erythrocyte sedimentation rate (ESR, in millimeters per hour [mm/hour]) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment on a 0 to 100 millimeter [mm] visual analog scale [VAS]; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with “Unspecified” reason of discontinuation were excluded for change from baseline analysis.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
1361282|NCT01665430|Primary|Percentage of Participants With Adverse Events (AEs), AEs of Special Interest and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include serious as well as non-serious AEs. AEs of special interest included: Infections including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives; Myocardial infarction/acute coronary syndrome; Gastrointestinal perforations and related events; Malignancies; Anaphylaxis/Hypersensitivity reactions; Demyelinating disorders; Stroke; Bleeding events; and Hepatic events.|Baseline up to 112 weeks|ITT population|||percentage of participants|||Number
1361283|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Sitting - 7. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
1361323|NCT01665053|Secondary|Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.||12 months|Intent-to-treat population.|||percentage of participants|||Number
1361285|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
1361286|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Interview - 4. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
1361287|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Preparation - 3. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
1361288|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Standing - 2. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
1361289|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
1361290|NCT01665170|Secondary|Norepinephrine (After)|2 min. after the TSST, higher value is better|1 day||||ng/dl||Standard Deviation|Mean
1361291|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361292|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.~V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361293|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361294|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1368804|NCT01581710|Primary|Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)|Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
1361295|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361296|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2, visite 3||||Percent Change||Standard Deviation|Mean
1361297|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361298|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361299|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361300|NCT01665170|Primary|VAS Stress Perception (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3||||mm||Standard Deviation|Mean
1361301|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.~V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
1361324|NCT01665053|Secondary|Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
1361302|NCT01665170|Secondary|MDBF Questionnaire|"The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = not at all to 5 = very true. To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3"|1 day|||||||
1361303|NCT01665170|Secondary|POMS Questionnaire|"The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = not at all to 7 = very strongly. The questionnaire is completed on V2 and V3."|1 day|||||||
1361304|NCT01665170|Secondary|State Anxiety (STAI-X1) Questionnaire|"The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = not at all to 4 = very true. The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3"|1 day|||||||
1361305|NCT01665170|Secondary|Norepinephrine (Before)|2 min. prior the TSST|before stress test||||ng/dl||Standard Deviation|Mean
1361306|NCT01665170|Secondary|Epinephrine (Before)|2 min. prior the TSST|1 day|||||||
1361307|NCT01665170|Secondary|ACTH (Pre-post Comparison)|ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST|1 day|||||||
1361308|NCT01665170|Secondary|Serum Cortisol (Pre-post Comparison)|2 min. prior to and 1 min. after the TSST|1 day|||||||
1361309|NCT01665170|Primary|VAS Anxiety (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3||||mm||Standard Deviation|Mean
1361310|NCT01665170|Primary|VAS Insecurity (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3||||mm||Standard Deviation|Mean
1361311|NCT01665157|Primary|Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)|"Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of right segment preparation failure, defined as segmental score as 3 poor or 4 inadequate, was presented."|1 day||||percentage of participants|||Number
1361312|NCT01665157|Secondary|Convenience of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who thinks the protocol is easy to use.|1 day||||percentage of participants|||Number
1361313|NCT01665157|Secondary|Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who is satisfied with the protocol.|1 day||||Percentage of participants|||Number
1361314|NCT01665157|Primary|Total Volume of Purgatives That Ingested|The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy|1 day||||Liter||Standard Deviation|Mean
1361315|NCT01665157|Secondary|Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol|It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.|1 day||||percentage of participants|||Number
1361316|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Aronchick Scale|"The overall proportion of participants scored as Excellent or Good by Aronchick scale.~Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present"|1 day||||percentage of participants|||Number
1361317|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale|Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.|1 day||||units on a scale||Standard Deviation|Mean
1361318|NCT01665053|Secondary|Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.|All CEC adjudicated revascularization at 12 month (Intent to treat population).|12 Month|Intent to treat population|||percentage of patients|||Number
1361319|NCT01665053|Secondary|Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.||12 month|Intent-to-Treat population|||percentage of participants|||Number
1361320|NCT01665053|Secondary|Periprocedural Clinical Procedural Success Rate|Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.|Day 1 (periprocedure)|Intent-to-Treat population|||percentage of subjects|||Number
1361321|NCT01665053|Secondary|Periprocedural Technical Success Rate.|Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.|Day 1 (periprocedure)|"Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions.~SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions."|||percentage of lesions|||Number
1361322|NCT01665053|Secondary|Percentage of Patients With a Stroke at 12 Month.|The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.|12 months|Intent-to-Treat population.|||percentage of participants|||Number
1361334|NCT01665053|Primary|Percentage of Participants With Target Lesion Failure (TLF) at 12 Months|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|12 months|The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module.|||percentage of participants|||Number
1361335|NCT01664975|Secondary|Median Survival Time||24 months||2016-12-31|12/2016||||
1361336|NCT01664975|Secondary|Overall Survival||up to the date of death (approximately 5 years)||2016-09-30|09/2016||||
1361337|NCT01664975|Secondary|Response Rate|21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles|every 6 weeks,up to completion of treatment(approximately 18 weeks )||2016-09-30|09/2016||||
1361338|NCT01664975|Primary|Progression-free Survival||up to end of follow-up-phase (approximately 24 months)||||participants|||Number
1361339|NCT01664949|Secondary|Change From Baseline in the Schirmer Test|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||mm/5 minutes||Standard Deviation|Mean
1361340|NCT01664949|Secondary|Change From Baseline in Conjunctival Staining|Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1361341|NCT01664949|Secondary|Change From Baseline in Corneal Staining|Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1361342|NCT01664949|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||seconds||Standard Deviation|Mean
1361343|NCT01664949|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1361344|NCT01664923|Secondary|Percentage of Participants With Adverse Event (AE)|"Assessment of adverse events was conducted from the date and time of the first dose of study drug through 30 days after the date of the last dose of study drug or before initiation of a cytotoxic or investigational therapy, whichever occurred first.~A serious adverse event was defined as any untoward medical occurrence that:~Resulted in death;~Was life threatening;~Required inpatient hospitalization or led to prolongation of hospitalization;~Resulted in persistent or significant disability or incapacity;~Resulted in a congenital anomaly or birth defect;~Was a medically important event.~An adverse event was considered related to the study drug if the event was assessed by the investigator as probably or possibly related."|From first dose of study drug up to 30 days after last dose of study drug. Median duration of the AE reporting period was 15.2 months in the enzalutamide arm and 9.4 months in the bicalutamide arm.|Safety population: All participants randomly assigned to study treatment who received at least 1 dose of study drug.|||percentage of participants|||Number
1361345|NCT01664923|Secondary|Best Overall Soft Tissue Response|Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.|||percentage of participants||95% Confidence Interval|Number
1361382|NCT01664117|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|At the time of change of treatment (to the current treatment)|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361346|NCT01664923|Secondary|Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)|"The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life.~Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation."|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
1361347|NCT01664923|Secondary|Duration of Radiographic PFS|Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants with metastatic disease at study entry and randomly assigned to study treatment.|||months||95% Confidence Interval|Median
1361348|NCT01664923|Secondary|Percentage of Participants With a PSA Response ≥ 50%|PSA response was defined as a reduction in PSA of at least 50% from baseline at any postbaseline assessment confirmed by a second PSA assessment at least 3 weeks later.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Evaluable intent-to-treat population: all participants randomly assigned to study treatment and had a baseline and at least 1 postbaseline PSA measurement.|||percentage of participants||95% Confidence Interval|Number
1361349|NCT01664923|Secondary|Time to PSA Progression|PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
1361350|NCT01664923|Primary|Progression Free Survival (PFS)|PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
1361351|NCT01664806|Secondary|Histologic Evidence of Burn at the Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day|A sample size of convenience for feasibility.|||participants|||Number
1361352|NCT01664806|Primary|Histologic Thermal Injury to Epigastric Port Site Skin|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.|1 day|A sample size of convenience for feasibility.|||participants|||Number
1361353|NCT01664793|Secondary|Effectiveness Score|Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).|End of February 2012||||units on a scale||Standard Deviation|Mean
1361354|NCT01664793|Primary|Primary Outcome|Influenza vaccination rates in each arm at the end of year 1|3/1/2011-2/29/2012||||participants vaccinated out of all|||Number
1361355|NCT01664624|Secondary|Change From Baseline to Day 11 in 24-hour Average Plasma Glucose|Plasma glucose was measured by Continuous Glucose Monitoring System (CGMS). CGMS measures glucose every 5 minutes, starting in the fasting state 8 hour prior to the standardized breakfast (12 AM) until 16 hours after the breakfast. The average 24-hour plasma glucose concentration was calculated. Least squares means were obtained using an ANCOVA model with treatment as fixed effect, and Baseline 24-hour Glucose Measured by CGMS as a continuous covariate.|Baseline (Day -1) and Day 11, from 12 AM through 24 hours.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||mg/dL||Standard Error|Least Squares Mean
1361400|NCT01664117|Secondary|Mean Time Between the Last sDMARD and bDMARD Received at Visit 1|Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.|At Visit 1|Analysis Population included all enrolled participants who met the inclusion criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Months||Standard Deviation|Mean
1361356|NCT01664624|Secondary|Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation|"Appetite sensations were measured using a visual analog scale (VAS) questionnaire. Participants were asked to indicate their level of fullness, hunger, satiety, and prospective consumption (how much do you think you can eat?) on a 100 mm line ranging from Not at all (0 mm) to extremely (100 mm). Appetite sensation scores before and up to 8 hours after eating were plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of appetite sensation VAS score as a continuous covariate."|At Baseline and Day 11, every 30 minutes, starting 1 hour before eating until 8 hour after the meal.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||mm*hr||Standard Error|Least Squares Mean
1361357|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of Insulin|The concentration of insulin in blood before and up to 8 hours after eating was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of insulin as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||pmol/L*hr||Standard Error|Least Squares Mean
1361358|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of C-peptide|The concentration of C-peptide in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of C-peptide as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||ng/mL*hr||Standard Error|Least Squares Mean
1361359|NCT01664624|Secondary|Change From Baseline in AUC(0-8) of Postprandial Plasma Glucose|The concentration of glucose in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and baseline postprandial AUC (0-8) of plasma glucose as a continuous covariate.|Baseline and Day 11 at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||mmol/L*hr||Standard Error|Least Squares Mean
1361360|NCT01664624|Primary|Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1|The concentration of glucagon-like peptide-1 (GLP-1) in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an analysis of covariance (ANCOVA) model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of active GLP-1 as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set defined as all randomized participants included in the safety analysis. Only participants with data at both Baseline and post-baseline visits are included.|||pmol/L*hr||Standard Error|Least Squares Mean
1361361|NCT01664559|Secondary|Post-insertion Provider Questionnaire|"The provider will be asked to fill out a multiple choice format questionnaire:~what level training are you?~which IUD was inserted?~what was the purpose of IUD placement?~what was the position of the uterus?~did the IUD placement process require cervical dilation?~were you able to complete the IUD insertion?~was there bleeding from the cervix that required more than 5 min to control?~were there any major complications with the IUD insertion?~did the patient take tylenol prior to leaving the office?"|Immediately after IUD placement, on average within 1 hour||||participants|||Number
1361362|NCT01664559|Secondary|Post-insertion Patient Questionnaire|"Questions assessed in multiple choice format:~Side effects~injection site pain~overall satisfaction with IUD insertion experience~would they still recommend IUD placement to a friend?~significant pain for which they desired acetaminophen prior to leaving the office?"|assessed at 15 minutes after IUD insertion||||participants|||Number
1361363|NCT01664559|Secondary|Nulliparous Patients - Subgroup Analysis|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.~Prior to injection of study drug, anticipated pain~Pain from study drug injection, measured immediately after injection~Pain from speculum insertion, measured immediately after insertion~Pain with tenaculum placement, measured immediately after placement~Pain with uterine sounding, measured immediately after removal of the sound~Pain at 5 minutes after placement of the intrauterine device~Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)||||cm||Inter-Quartile Range|Median
1361364|NCT01664559|Secondary|Pain Scores at Other Time Points During and After IUD Placement|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.~Prior to injection of study drug, anticipated pain~Pain from study drug injection, measured immediately after injection~Pain from speculum insertion, measured immediately after insertion~Pain with tenaculum placement, measured immediately after placement~Pain with uterine sounding, measured immediately after removal of the sound~Pain at 5 minutes after placement of the intrauterine device~Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)||||cm||Inter-Quartile Range|Median
1361365|NCT01664559|Primary|VAS (Visual Analogue Scale) Measurement of Pain|The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.|Pain with IUD placement, measured immediately after placement||||units on a scale||Inter-Quartile Range|Median
1361366|NCT01664533|Secondary|Percentage of Participants Who Developed Diarrhea||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.|||percentage of participants||95% Confidence Interval|Number
1390134|NCT01355978|Secondary|Safety and Device-related Adverse Events|Any adverse events reported during he study period.|Continuous from Study Day 2 through Study Day 6||||participants|||Number
1361369|NCT01664533|Secondary|Best Overall Response|Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Percentage of participants||97.5% Confidence Interval|Number
1361370|NCT01664533|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.|||Months||95% Confidence Interval|Median
1361371|NCT01664494|Secondary|Median Dose of Capecitabine|Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.|||Milligrams||Full Range|Median
1361372|NCT01664494|Primary|Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment|Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.|||Participants|||Number
1361373|NCT01664247|Secondary|Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)|Change in subject’s quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 3 subjects PRO scores were missing at the baseline and did not contribute to the analysis.|||T-scores||Standard Deviation|Mean
1361374|NCT01664247|Secondary|Number of Adverse Events|Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0 - 26|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1361375|NCT01664247|Secondary|Number of Hypoglycaemic Episodes|Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.|Weeks 0 - 26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1361376|NCT01664247|Secondary|Change From Baseline in Mean of the 8-point Profile|Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects and missing data is imputed using LOCF. Mean values were missing for 11 subjects.|||mmol/L||Standard Deviation|Mean
1361377|NCT01664247|Secondary|Change From Baseline in 8-point Profile|The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects. The subjects not analysed were 12, 45, 46, 44, 44, 54, 56 and 21 subjects for before breakfast, 90 mins after breakfast, before lunch, 90 mins after start of lunch, before main evening meal, 90 mins after main evening meal, before bedtime and before breakfast the following day time points respectively.|||mmol/L||Standard Error|Least Squares Mean
1361378|NCT01664247|Secondary|Change From Baseline in Mean Pre-breakfast Measurements Used for Titration|Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects the baseline values were missing|||mmol/L||Standard Error|Least Squares Mean
1361379|NCT01664247|Secondary|Number of Responders for HbA1c (Below 7.0 %)|Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.|After 26 weeks of randomised treatment.|The FAS included all randomised subjects and missing data was imputed using LOCF.|||percentage (%) of subjects|||Number
1361380|NCT01664247|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects FPG values were missing.|||mmol/L||Standard Deviation|Mean
1361383|NCT01664117|Secondary|Number of Participants With Adverse Events Leading to a Change of Treatment|An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.|At the time of change of treatment|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361384|NCT01664117|Secondary|Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361385|NCT01664117|Secondary|Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Number of joints||Standard Deviation|Mean
1361386|NCT01664117|Secondary|Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score|Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361387|NCT01664117|Secondary|Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study|Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
1361388|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Number of sDMARD/bDMARDs/Other||Standard Deviation|Mean
1361389|NCT01664117|Secondary|Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||years||Standard Deviation|Mean
1361390|NCT01664117|Secondary|Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study|Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361391|NCT01664117|Secondary|Number of Participants With Reasons for Starting Current Biologic Monotherapy|The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361392|NCT01664117|Secondary|Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy|Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361393|NCT01664117|Secondary|Number of Participants Received Current bDMARD Treatment at the Time of the Study|Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361394|NCT01664117|Secondary|Number of Participants Treated With Concomitant Medications Before the Study|Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361395|NCT01664117|Secondary|Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment|Median time in months taking the Biologic Agent in monotherapy before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Months||Full Range|Median
1361396|NCT01664117|Secondary|Number of Participants Discontinued the Previous Treatment and Started the Study Treatment|The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361397|NCT01664117|Secondary|Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361398|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)|Number of sDMARD and bDMARDs received by Participants before the study was presented|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Number of sDMARD/bDMARD||Standard Deviation|Mean
1361399|NCT01664117|Secondary|Number of Participants With Changing the Previous sDMARD/ bDMARD|Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ represents the number of participants analyzed at a specified time point.|||Participants|||Number
1362277|NCT01656850|Primary|Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mU.min/L||Standard Deviation|Mean
1361401|NCT01664117|Secondary|Number of Participants Who Received Each bDMARD Before the Study|Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361402|NCT01664117|Secondary|Number of Participants Prescribed First bDMARD Before the Study|Number of participants prescribed first bDMARD before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361403|NCT01664117|Secondary|Number of Participants Who Received Last sDMARD Prescribed Before the Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
1361404|NCT01664117|Secondary|Number of Participants Who Received Each sDMARD Before The Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361405|NCT01664117|Secondary|Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug|Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ = number of participants prescribed with first sDMARD or bDMARD.|||Months||Standard Deviation|Mean
1361406|NCT01664117|Secondary|Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study|Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361407|NCT01664117|Primary|Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1|SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361408|NCT01664117|Primary|Mean Score on Simple Disease Activity Index at Visit 1|Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Scores on a scale||Standard Deviation|Mean
1361409|NCT01664117|Primary|Number of Participants With Clinical Disease Activity by Categorization at Visit 1|CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361410|NCT01664117|Primary|Mean Score on Clinical Disease Activity Index at Visit 1|Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Scores on a scale||Standard Deviation|Mean
1361411|NCT01664117|Primary|Number of Participants With Disease Activity Score by Categorization at Visit 1|DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high >5.1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361412|NCT01664117|Primary|Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1|Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
1361413|NCT01664117|Primary|Number of Participants With Joint Damage at Visit 1|Number of participants with joint damage is recorded as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361414|NCT01664117|Primary|Patient Pain Visual Analog Scale Score at Visit 1|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain"|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. Out of 209 participants, 207 were analysed for patient pain visual analog scale.|||Units on a scale||Standard Deviation|Mean
1361415|NCT01664117|Primary|Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1|The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361447|NCT01664104|Secondary|Percentage of Participants by Reason for DMARD Withdrawal During the Study|"DMARDs that met the criteria for concomitant medications were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361416|NCT01664117|Primary|Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies|Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants|||Participants|||Number
1361417|NCT01664117|Primary|Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1|Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' =number of evaluated participants|||Participants|||Number
1361418|NCT01664117|Primary|Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1|Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants|||Participants|||Number
1361419|NCT01664117|Primary|Patient’s Global Assessment of Disease Activity at Visit 1|Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
1361420|NCT01664117|Primary|Physician’s Global Assessment of Disease Activity at Visit 1|The Physician’s global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
1361421|NCT01664117|Primary|Mean Number of Painful and Swollen Joints at Visit 1|Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Number of joints||Standard Deviation|Mean
1361422|NCT01664117|Primary|Number of Participants With Extra-articular Manifestations at Visit 1|Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty’s syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361423|NCT01664117|Primary|Number of Participants With Co-morbidities|Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361424|NCT01664117|Primary|Number of Participants With Family History of Rheumatoid Arthritis|Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361425|NCT01664117|Primary|Mean Time of Onset of Rheumatoid Arthritis|Onset of rheumatoid arthritis is a component of clinical characteristics.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Years||Standard Deviation|Mean
1361426|NCT01664117|Primary|Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )|Smoking-habit included years of smoking/quit smoking is reported for participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' = number of evaluated participants|||Years||Standard Deviation|Mean
1361427|NCT01664117|Primary|Smoking-habit for Smokers or Ex-smokers (Packs in Years)|Smoking-habit included number of pack per years is reported.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n = number of evaluated participants|||Years||Standard Deviation|Mean
1361428|NCT01664117|Primary|Number of Participants With Smoking Habits|Smoking habits is a component of socio-demographic characteristics. Participants’ smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
1361429|NCT01664117|Primary|Number of Participants With Level of Education Completed|Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)|At Visit 1 (Single visit study)|Analysis population included all enrolled participants who met the screening criteria|||Participants|||Number
1361430|NCT01664104|Secondary|Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
1361431|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
1361432|NCT01664104|Secondary|Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
1361433|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
1361434|NCT01664104|Secondary|Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
1361435|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6|CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
1361436|NCT01664104|Secondary|Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6|The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
1361437|NCT01664104|Secondary|BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6|Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||Kg/m^2||Standard Deviation|Mean
1394774|NCT01313182|Secondary|Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.|Lab will culture isolates when time and money permit|Isolates collected and frozen|||||||
1361438|NCT01664104|Secondary|CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.|||mg/dL||Standard Deviation|Mean
1361439|NCT01664104|Secondary|Percentage of Participants by Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361440|NCT01664104|Secondary|Percentage of Participants With and Without Morning Stiffness|"Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:~Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);~Duration of morning stiffness, measured by ticking 1 of the six categories: < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day;~Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.~'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed."|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361441|NCT01664104|Secondary|Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6|DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.|||kilogram per meter square (Kg/m^2)||Standard Deviation|Mean
1361442|NCT01664104|Secondary|CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.|||mg/dL||Standard Deviation|Mean
1361443|NCT01664104|Secondary|Change From Baseline in ESR at Month 3 and Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X – ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm/hr||Standard Deviation|Mean
1361444|NCT01664104|Secondary|Change From Baseline in CRP at Month 3 and Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X – CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mg/dL||Standard Deviation|Mean
1361445|NCT01664104|Secondary|Time to Steroid Dose Withdrawal|"Steroids that met the criteria for concomitant medications were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
1361446|NCT01664104|Secondary|Time to Steroid Dose Reduction|"Steroids that met the criteria for concomitant medications were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
1361448|NCT01664104|Secondary|Time to DMARD Dose Withdrawal|"DMARDs that met the criteria for concomitant medications were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
1361449|NCT01664104|Secondary|Time to DMARD Dose Reduction|"DMARDs that met the criteria for concomitant medications were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
1361450|NCT01664104|Secondary|Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of >1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL >1.2 with DAS28 score > 3.2 to ≤ 5.1 or a chg from BL > 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL < 0.6 regardless initial DAS28 score or > 0.6 to ≤ 1.2 with DAS28 score of > 5.1.|Month 3 and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
1361451|NCT01664104|Secondary|Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361452|NCT01664104|Secondary|Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361453|NCT01664104|Secondary|Change From Baseline to Month 6 in Participant Assessment of Fatigue|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361454|NCT01664104|Secondary|Change From Baseline to Month 6 in HAQ-DI Score|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1361455|NCT01664104|Secondary|Change From Baseline to Month 6 in Patient's Assessment of Pain|Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361456|NCT01664104|Secondary|Change From Baseline to Month 6 in PhGH|The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361457|NCT01664104|Secondary|Change From Baseline to Month 6 in PGH|The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361458|NCT01664104|Secondary|Change From Baseline to Month 6 in SJC|SJC was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline and at Month 6. No swelling = 0 and swelling = 1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||swollen joints||Standard Deviation|Mean
1361459|NCT01664104|Secondary|Change From Baseline to Month 6 in TJC|TJC was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline and at Month 6. No tenderness = 0 and tenderness = 1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||tender joints||Standard Deviation|Mean
1361460|NCT01664104|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment|ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient’s assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361461|NCT01664104|Secondary|Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6|CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
1361462|NCT01664104|Secondary|Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6|SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
1361463|NCT01664104|Secondary|Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6|DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of < 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of >3.2 and ≤ 5.1 represents moderate disease activity, and a score of > 5.1 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for this outcome and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
1361464|NCT01664104|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6|The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X – CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1361465|NCT01664104|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6|SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X – SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1361466|NCT01664104|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6|DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of < 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of > 3.2 and ≤ 5.1 represents moderate disease activity and a score of > 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X – DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1361467|NCT01664104|Secondary|Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361468|NCT01664104|Secondary|Percentage of Participants With TCZ Reintroduction|"The percentage of participants with at least one TCZ reintroduction was reported as Yes. Participants with unknown TCZ reintroduction were set to No."|Baseline up to Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
1361469|NCT01664104|Secondary|Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation||Baseline up to Month 6|All enrolled participants evaluable for primary objective who discontinued TCZ.|||percentage of participants|||Number
1361470|NCT01664104|Secondary|Percentage of Participants With TCZ Infusion Interruption|"The percentage of participants with at least one infusion interruption was reported as Yes. Participants with unknown infusion interruption were set to No."|Baseline up to Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
1361471|NCT01664104|Secondary|Time in Days Elapsed Between TCZ Infusions|The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.|Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||days||Inter-Quartile Range|Median
1361472|NCT01664104|Secondary|Percentage of Participants by Number of TCZ Dose Modifications Per Participant|The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.|Baseline up to Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
1361473|NCT01664104|Secondary|Number of Participants With TCZ Dose Change According to the Reason for Change|Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.|Baseline up to Month 6|All enrolled participants evaluable for the primary objective and had TCZ dose modification.|||participants|||Number
1361474|NCT01664104|Secondary|Percentage of Participants by Duration of Morning Stiffness at Baseline|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.|Baseline|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
1361475|NCT01664104|Secondary|Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361476|NCT01664104|Secondary|Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline|RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361477|NCT01664104|Secondary|Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361478|NCT01664104|Secondary|Percentage of Participants With Evidence of Structural Joint Damage at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361479|NCT01664104|Secondary|Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline|Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
1361480|NCT01664104|Secondary|C-Reactive Protein (CRP) at Baseline|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1361515|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FVC data at both baseline and week 12|||Litres||Standard Deviation|Mean
1361481|NCT01664104|Secondary|Erythrocyte Sedimentation Rate (ESR) at Baseline|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm/hour||Standard Deviation|Mean
1361482|NCT01664104|Secondary|Swollen Joint Count (SJC) at Baseline|SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||swollen joints||Standard Deviation|Mean
1361483|NCT01664104|Secondary|Tender Joint Count (TJC) at Baseline|TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||tender joints||Standard Deviation|Mean
1361484|NCT01664104|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1361485|NCT01664104|Secondary|Participant Assessment of Fatigue Using VAS at Baseline|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361486|NCT01664104|Secondary|Participant Assessment of Morning Stiffness Using VAS at Baseline|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361487|NCT01664104|Secondary|Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline|The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361488|NCT01664104|Secondary|Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline|The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361489|NCT01664104|Secondary|Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline|Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
1361490|NCT01664104|Secondary|Time Elapsed From Diagnosis of RA|Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.|Baseline (assessed retrospectively)|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||years||Full Range|Median
1361491|NCT01664104|Secondary|Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|"Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in IR to biologic group. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the DMARDs intolerance and/or IR group."|Baseline|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
1361492|NCT01664104|Secondary|Percentage of Participants by TCZ Dose at Month 6|TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.|Month 6|All enrolled participants evaluable for primary objective and who did not interrupt TCZ at Month 6.|||percentage of participants|||Number
1361493|NCT01664104|Primary|Percentage of Participants on TCZ Treatment at Month 6|Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.|Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants||95% Confidence Interval|Number
1361494|NCT01664052|Primary|Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|90 days after insert placement||||Occluded fallopian tubes|Participants||Number
1394775|NCT01313182|Secondary|Measure Adverse Events Related to Mupirocin and Povidone-iodine.|Patients were given an adverse event log to complete after treatment|At time of treatment|||||||
1361495|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|60 days after insert placement||||Occluded fallopian tubes|Participants||Number
1361496|NCT01664052|Primary|Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|30 days after insert placement||||Occluded fallopian tubes|Participants||Number
1361497|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.|60 minutes after insert placement||||Occluded fallopian tubes|Participants||Number
1361498|NCT01664039|Secondary|Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6|TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||seconds||Standard Deviation|Mean
1361499|NCT01664039|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6|"The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health."|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1361500|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6|Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.|||participants|||Number
1361501|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6|Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.|||participants|||Number
1361502|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit|Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.|||participants|||Number
1361503|NCT01664039|Secondary|Percentage of Subjects Who Reached Target IOP at Each Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Week 6, Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||percentage of participants|||Number
1361504|NCT01664039|Secondary|Mean Change From Baseline in IOP at Week 6 and Month 3|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||mmHg||Standard Deviation|Mean
1361528|NCT01663740|Secondary|Change in Prolactin Level From EOT to End of FU|Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mU/mL||Standard Error|Mean
1361505|NCT01664039|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||mmHg||Standard Deviation|Mean
1361506|NCT01663987|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Time to event: Time to recovery (EXACT-PRO) was not analysed, only Kaplan meier curve was plotted. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2 and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|||||||
1361507|NCT01663987|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477|||Hospitalisation per patient year|||Number
1361508|NCT01663987|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477|||exacerbations per patient year|||Number
1361509|NCT01663987|Secondary|Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with 30-day hospital readmission rates outcome events was analysed.~Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.~The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|from date of hospital discharge prior to randomization up to readmission days >1 and <31 days|Treated set of the pooled twin studies 205.478 and 205.477|||Percentage of participants|||Number
1361510|NCT01663987|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.~All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures. Hospitalizations occurring on the same day as discharge were not considered a separate admission.~This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477|||Percentage of participants|||Number
1361511|NCT01663987|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with COPD exacerbation on study was analysed for the combined study.~A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following: 1) Shortness of breath; 2) Sputum production (volume); 3)Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness. Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.~A required change in treatment included either prescription of antibiotics and/or systemic steroids; and a newly prescribed maintenance respiratory medication (i.e. bronchodilators including theophyllines and PDE4-inhibitors).~This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477|||Percentage of participants|||Number
1361512|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.~This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated set of the pooled twin studies 205.478 and 205.477|||Litres||Standard Deviation|Mean
1361513|NCT01663987|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of Trough FEV1 (forced expiratory volume in one second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.~This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated set of the pooled twin studies 205.478 and 205.477|||Litres||Standard Deviation|Mean
1361514|NCT01663987|Secondary|Percentage of Patients With Adverse Clinical Event on Study|Percentage of patients with adverse clinical event during on study, which is defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalisation, or all cause mortality.|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set|||Percentage of participants|||Number
1361516|NCT01663987|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.~Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477: This set includes all patients who were randomised and took at least one dose of study drug, 157 patients (79 Tiotropium and 78 placebo) were included in this set.|||Percentage of perticipants|||Number
1361517|NCT01663987|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug|Change from baseline in trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FEV1 data at both baseline and week 12|||Litres||Standard Deviation|Mean
1361518|NCT01663922|Primary|Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort)|"Pharmacokinetic parameters (maximum and trough concentrations, and area under concentratof boceprevir and SJW will be evaluated when given in combination at steady-state to evaluate possible differences in concentrations during co-administration versus drug given alone.~The pharmacokinetic parameters calculated for boceprevir and SJW will be Ctrough,the maximum observed plasma concentration (Cmax), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve.~All pharmacokinetic parameters will be calculated using non-compartmental modelling techniques (WinNonlin®) and all statistical calculations performed within-participant changes in the assessed pharmacokinetic parameters (drug alone vs drug combination) will be evaluated by calculating geometric mean ratios."|6 months|All participants who completed the three PK assessments were included in the analysis. BCP metabolites (SCH534128 & SCH523129) PK parameters were determined in the presence and absence of SJW, and hypericin PK parameters in the presence and absence of BCP; for the total study population.|||ng*h/mL||90% Confidence Interval|Geometric Mean
1361519|NCT01663779|Primary|First Pass Success When Attempting Arterial Catheterization.|first pass success when attempting arterial catheterization of the artery|Immediate, upon study entry||||participants|||Number
1361520|NCT01663740|Secondary|Percentage of Participants With Improved Sperm Density From EOT to End of FU|Participants who had higher sperm density compared with the previous visit were considered as improved.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
1361521|NCT01663740|Secondary|Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU|Participants who had higher sperm density compared with the previous visit were considered as improved.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of participants|||Number
1361522|NCT01663740|Secondary|Percentage of Participants With Improved TUNEL Score From EOT to End of FU|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
1361523|NCT01663740|Secondary|Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of participants|||Number
1361524|NCT01663740|Secondary|Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU|Abnormal sperm density was considered as sperm density <20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
1361525|NCT01663740|Secondary|Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU|Abnormal sperm density was considered as sperm density less than (<) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of participants|||Number
1361526|NCT01663740|Secondary|Change in Inhibin B Level From EOT to End of FU|Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||pg/mL||Standard Error|Mean
1361527|NCT01663740|Secondary|Change in Inhibin B Level From Baseline to EOT and End of FU|Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||pg/mL||Standard Error|Mean
1362278|NCT01656850|Primary|Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mU/L||Standard Deviation|Mean
1361529|NCT01663740|Secondary|Change in Prolactin Level From Baseline to EOT and End of FU|Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||mU/mL||Standard Error|Mean
1361530|NCT01663740|Secondary|Change in FSH Level From EOT to End of FU|FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||U/L||Standard Error|Mean
1361531|NCT01663740|Secondary|Change in FSH Level From Baseline to EOT and End of FU|FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||U/L||Standard Error|Mean
1361532|NCT01663740|Secondary|Change in LH Level From EOT to End of FU|LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mU/mL||Standard Error|Mean
1361533|NCT01663740|Secondary|Change in LH Level From Baseline to EOT and End of FU|LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||mU/mL||Standard Error|Mean
1361534|NCT01663740|Secondary|Change in Total Testosterone Level From EOT to End of FU|Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||nmol/L||Standard Error|Mean
1361535|NCT01663740|Secondary|Change in Total Testosterone Level From Baseline to EOT and End of FU|Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||nmol/L||Standard Error|Mean
1361536|NCT01663740|Secondary|Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU|Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of normal sperm cells||Standard Error|Mean
1361537|NCT01663740|Secondary|Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU|Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of normal sperm cells||Standard Error|Mean
1361538|NCT01663740|Secondary|Change in Total Motility of Sperm From EOT to End of FU|Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percent motility||Standard Error|Mean
1361539|NCT01663740|Secondary|Change in Total Motility of Sperm From Baseline to EOT and End of FU|Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percent motility||Standard Error|Mean
1361540|NCT01663740|Secondary|Change in Sperm Density From Baseline to End of FU|Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).|Baseline, end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mil/mL||Standard Error|Mean
1364161|NCT01637077|Secondary|The Percentage of Patients Taking Opioid Medications|The percentage of patients taking opioid medications are reported below by arm.|From treatment initiation to 6 months.||||percentage of patients|||Number
1361541|NCT01663740|Secondary|Change in Sperm Density From EOT to End of FU|Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mil/mL||Standard Error|Mean
1361542|NCT01663740|Secondary|Change in Seminal Volume From EOT to End FU|Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mL||Standard Error|Mean
1361543|NCT01663740|Secondary|Change in Seminal Volume From Baseline to EOT and End of FU|Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||mL||Standard Error|Mean
1361544|NCT01663740|Secondary|Change in TUNEL Score From EOT to End of FU|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percent score||Standard Error|Mean
1361545|NCT01663740|Secondary|Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percent score||Standard Error|Mean
1361546|NCT01663740|Primary|Change in Sperm Density From Baseline to the End of Treatment (EOT)|Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).|Baseline, EOT (Week 28)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mil/mL||Standard Error|Mean
1361547|NCT01663727|Secondary|Percentage of Participants Who Were Alive at 1 Year||1 year|||||||
1361548|NCT01663727|Secondary|Duration of Response - High Baseline Plasma VEGF-A ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.|||months||95% Confidence Interval|Median
1361549|NCT01663727|Secondary|Duration of Response - ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population who had an objective response.|||months||95% Confidence Interval|Median
1361550|NCT01663727|Secondary|Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
1361551|NCT01663727|Primary|PFS in High Baseline Plasma VEGF-A ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population.|||months||95% Confidence Interval|Median
1361552|NCT01663727|Primary|Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population|Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.|||percentage of participants|||Number
1361553|NCT01663727|Secondary|Percentage of Participants With an Objective Response - ITT Population|Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
1361554|NCT01663727|Secondary|OS - High Baseline Plasma VEGF-A ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 90.9 weeks)|High Baseline Plasma VEGF-A ITT population.|||months||95% Confidence Interval|Median
1361555|NCT01663727|Secondary|Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population||From randomization till death or clinical cut-off (up to 90.9 weeks)|High Baseline Plasma VEGF-A ITT Population.|||percentage of participants|||Number
1361556|NCT01663727|Secondary|Overall Survival (OS) - ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 111.7 weeks)|ITT population.|||months||95% Confidence Interval|Median
1361557|NCT01663727|Secondary|Percentage of Participants Who Died - ITT Population||From randomization till death or clinical cut-off (up to 111.7 weeks)|ITT Population.|||percentage of participants|||Number
1361558|NCT01663727|Primary|Progression Free Survival (PFS) in ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.|||months||95% Confidence Interval|Median
1361559|NCT01663727|Primary|Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population|Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.|||percentage of participants|||Number
1361560|NCT01663714|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||months||95% Confidence Interval|Median
1361561|NCT01663714|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be positive, a participant had to have a positive HAMA assessment during the first 24 months."|Day 1 to Day 730 (24 months) after receiving the dosimetric dose|ITT Exposed Population|||participants|||Number
1361562|NCT01663714|Secondary|Number of Participants Who Received Any Supportive Care|Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population|||participants|||Number
1361563|NCT01663714|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. All participants who died during the study were analyzed.|||participants|||Number
1361564|NCT01663714|Secondary|Number of Participants With Any Treatment-related Serious Adverse Event (SAE)|An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed.|||participants|||Number
1361565|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
1361566|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
1361567|NCT01663714|Secondary|Nadir Values for WBC Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||10^3 cells/µL||Full Range|Median
1361568|NCT01663714|Secondary|Nadir Values for Platelet Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||10^3 cells/microliter (µL)||Full Range|Median
1361569|NCT01663714|Secondary|Nadir Values for Hemoglobin|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||Grams/deciliter (g/dL)||Full Range|Median
1361570|NCT01663714|Secondary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||10^3 cells/cubic millimeters (mm^3)||Full Range|Median
1361571|NCT01663714|Secondary|Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations|TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline.|||days||95% Confidence Interval|Median
1361572|NCT01663714|Secondary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||days||Full Range|Median
1361573|NCT01663714|Secondary|Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD|To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.|Day (D) 0; D 2, 3, or 4; and D 6 or 7|ITT Exposed Population|||hours||Standard Deviation|Mean
1361635|NCT01663103|Primary|Change in Flow-mediated Dilation (FMD)|Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment||||change in percent flow-mediated dilation||Standard Deviation|Mean
1361574|NCT01663714|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis.|||months||95% Confidence Interval|Median
1361575|NCT01663714|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis.|||months||95% Confidence Interval|Median
1361576|NCT01663714|Secondary|DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.|||months||95% Confidence Interval|Median
1361577|NCT01663714|Secondary|Duration of Response (DOR), as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.|||months||95% Confidence Interval|Median
1361578|NCT01663714|Secondary|Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
1361579|NCT01663714|Secondary|Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
1361580|NCT01663714|Primary|Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.|||participants|||Number
1361581|NCT01663714|Primary|Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.|||participants|||Number
1361582|NCT01663623|Secondary|Number of Participants With Major Relapse During the Double-blind Phase of the Study|Data for number of participants with major relapse [defined as experiencing at least 1 major Birmingham Vasculitis Activity Score (BVAS) item] during the double-bind phase of the study was reported. Analysis was performed using a Cox proportional hazard model.|Approximately up to 4 years|Intent-to-treat population|||Participants|||Number
1361583|NCT01663623|Primary|Time to First Relapse|Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date – treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.|Approximately up to 4 years|Intent-to-treat population|||Days||Inter-Quartile Range|Median
1361584|NCT01663532|Secondary|Responder Rate Based on PANSS Total Score.|Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.|||participants|||Number
1361585|NCT01663532|Secondary|Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.|||Units on a scale||Standard Deviation|Mean
1361586|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.|The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Week 10|Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.|||Units on a scale||Standard Error|Least Squares Mean
1361587|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
1361588|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
1361589|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
1361636|NCT01663012|Secondary|Overall Survival From Time of Diagnosis|Will be described using Kaplan-Meier estimates.|From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years.||||Months||95% Confidence Interval|Median
1361590|NCT01663532|Primary|Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
1361591|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on CDAI Score|Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score <= 2.8; low disease activity: CDAI <=10.0; moderate disease activity: CDAI <=22.0; and high disease activity: CDAI >22.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
1361592|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on SDAI Score|Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score <= 3.3; low disease activity: SDAI <=11.0; moderate disease activity: SDAI <=26.0; and high disease activity: SDAI >26.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
1361593|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on DAS28 Score|Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score <= 2.6; low disease activity: DAS28 <=3.2; moderate disease activity: DAS28 <=5.1; and high disease activity: DAS28 >5.1.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
1361594|NCT01663506|Secondary|Number of Participants Receiving Oral Corticosteroids||Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||participants|||Number
1361595|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.|||participants|||Number
1361596|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab as Monotherapy||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.|||participants|||Number
1361597|NCT01663506|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
1361598|NCT01663506|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
1361599|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 28 Joints|Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.|||joints count||Standard Deviation|Mean
1361600|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 66 and 68 Joints|Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.|||joints count||Standard Deviation|Mean
1361601|NCT01663506|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mg/L||Standard Deviation|Mean
1361602|NCT01663506|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm/hr||Standard Deviation|Mean
1361603|NCT01663506|Secondary|Visual Analog Scale-Morning Stiffness (VAS-MS)|Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
1361604|NCT01663506|Secondary|Visual Analog Fatigue Scale (VAFS)|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
1361605|NCT01663506|Secondary|Visual Analog Scale (VAS)-Pain|Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
1361606|NCT01663506|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
1361607|NCT01663506|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
1361608|NCT01663506|Secondary|Physician Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
1361609|NCT01663506|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline >1.2 with DAS28 <= 3.2; moderate responders: decrease from baseline >1.2 with DAS28 >3.2 or decrease from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: decrease from baseline <= 0.6 or decrease from baseline >0.6 and <=1.2 with DAS28 >5.1.|Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
1361610|NCT01663506|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (<=) 2.6 meant clinical remission; DAS28 <=3.2 meant low disease activity; DAS28 greater than (>) 3.2 to 5.1 implied moderate disease activity; and DAS28 >5.1 implied high disease activity.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
1361611|NCT01663506|Secondary|Number of Participants With Prior Exposure of Biologics||Baseline|FAS.|||participants|||Number
1361612|NCT01663506|Secondary|Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline|FAS.|||participants|||Number
1361613|NCT01663506|Secondary|Number of Participants With Comorbidities at Baseline|Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.|Baseline|FAS.|||participants|||Number
1361614|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity|Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (>=) 75 days between two consecutive doses of study drug.|Up to Month 12|FAS.|||percentage of participants|||Number
1361615|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation||Month 12|FAS.|||percentage of participants||95% Confidence Interval|Number
1361616|NCT01663506|Primary|Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation||6 Months|FAS.|||percentage of participants||95% Confidence Interval|Number
1361617|NCT01663363|Secondary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||6 Months|Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure “Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better“.|||percentage of eyes|Participants|95% Confidence Interval|Number
1361618|NCT01663363|Primary|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|"Data from 334 eyes of 170 participants are included for the outcome measure Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)."|||percentage of eyes|Participants|95% Confidence Interval|Number
1361619|NCT01663285|Secondary|Number of Participants With Adverse Events|The safety of neoadjuvant chemotherapy.|9 years|Due to poor patient enrollment this outcome was not able to be analyzed.||||||
1361620|NCT01663285|Secondary|Number of Patients With Pathologic T0/Tis/Ta N0.|The proportion of patients with pathologic T0/Tis/Ta N0.|51 months|Due to poor patient enrollment this outcome was not able to be analyzed.||||||
1361621|NCT01663285|Primary|Recurrence-free Survival Time|The 2-year recurrence-free survival (RFS) time for patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma.|2 years after participant surgery|Due to poor patient enrollment the primary objective was not able to be analyzed.||||||
1361622|NCT01663233|Secondary|Number of Participants With Adverse Event|Participants were monitored for adverse events, serious adverse events and death.|8 weeks|Safety Set: The safety set included all randomized participants who received at least one dose of study medication.|||Participants|||Number
1361623|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)|The number of participants who achieved successful treatment response in msDBP of < 90mmHg or a reduction ≥ 10mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as having a successful response.|8 weeks of treatment|FAS|||Participants|||Number
1361624|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)|The number of participants who achieved successful treatment response in the msSBP of < 140mmHg or a reduction ≥ 20 mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as a having a successful response.|8 weeks|FAS|||Participants|||Number
1361625|NCT01663233|Secondary|Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)|The number of participants achieving a systolic and diastolic blood pressure < 140/90 mmHg was measured. This outcome measure shows how well a given blood pressure treatment can achieve a given blood pressure target or goal. Participants who achieved the target blood pressure were determined based on the mean SBP and DBP measurements taken at the end of the study. If the participants' BP measurement was below the above target, they were considered to have successful blood pressure control.|8 weeks|FAS|||Participants|||Number
1361626|NCT01663233|Secondary|Change in Sitting Pulse Pressure (PP)|The change in the patient's mean sitting PP from baseline to end of the study was measured. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
1361627|NCT01663233|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The change in the patient's msDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
1361628|NCT01663233|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|The change in the patient's msSBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
1361629|NCT01663233|Secondary|Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)|The change in mean 24 hour maDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.|||mmHg||Standard Error|Least Squares Mean
1361630|NCT01663233|Primary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)|The change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups was measured. A greater reduction from baseline in the LCZ696 group indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.|||mmHg||Standard Error|Least Squares Mean
1361631|NCT01663103|Other Pre-specified|Change in Vascular Endothelial NADPH Oxidase Expression|Vascular endothelial cells will be collected and assessed for changes in protein expression of NADPH oxidase after 3 months of treatment with rilonacept vs. placebo. Protein expression is calculated as a ratio of intensity of staining in the patient cells relative to human umbilical vein endothelial cell (HUVEC) control cells. The absolute change in this ratio between baseline and week 12 is reported below.|3 months after start of treatment|sub-group from Denver site|||absolute change in ratio||Standard Deviation|Mean
1361632|NCT01663103|Other Pre-specified|Change in High-sensitivity C-reactive Protein (hsCRP)|Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation.|3 months after start of treatment||||change in c-reactive protein (mg/L)||Inter-Quartile Range|Median
1361633|NCT01663103|Secondary|Change in Contribution of Oxidative Stress to FMD|FMD will be assessed following acute infusion of ascorbic acid compared to saline. The improvement in FMD with ascorbic acid reflects the degree of oxidative stress contributing to impairment in FMD.|3 months after start of treatment|sub-group from Denver site|||change in percent flow-mediated dilation||Standard Deviation|Mean
1361634|NCT01663103|Secondary|Change in Aortic Pulse-wave Velocity (aPWV)|Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment||||change in pulse-wave velocity (cm/sec)||Standard Deviation|Mean
1361638|NCT01663012|Primary|Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria|Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability).|6 weeks from first administration of NKTR-102||||participants|||Number
1361639|NCT01662999|Secondary|Number of Participants With Change From Baseline in ECG Interval - Safety Population|A 12-Lead electrocardiogram (ECG) was performed and recorded after the participant had been supine for at least 5 minutes. ECGs done at baseline (Day-1 of Period 1) and at end of study; therefore the results are presented by sequence, and cannot be presented by treatment. QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). Abnormality criteria: QT/QTcF QT or QTcF >450 msec and <=480 msec at any postdose time point and not present at baseline. QT or QTcF >480 msec and <=500 msec at any postdose time point and not present at baseline QT or QTcF >500 msec at any postdose time point and not present at baseline. QT/QTcF Increase from baseline >60 msec for at least 1 postdose measurement. Increase from baseline in QT or QTcF >30 msec for at least 1 postdose measurement, but <=60 msec for all postdose measurements.|Baseline to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
1361640|NCT01662999|Secondary|Number of Participants With Marked Urinalysis Laboratory Abnormalities - Safety Population|Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Fasted for 10 hours prior to samples taken. LLN=lower limit of normal; ULN=upper limit of normal; pretreatment (Pre-Rx). Normals: Urine glucose qualitative: dipstick >=1 if Pre-Rx <1 or 2*Pre-Rx if Pre-Rx>=1; urine microscopic white blood cell count (WBC): >=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2;urine red blood cell count (RBC):>=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug. Urine WBC and RBC were not done for all 42 participants. Number of participants analyzed (N) for the 3 treatments for WBC/RBC urine were 4, 8, 6, in treatment A, B, C, respectively.|||participants|||Number
1361641|NCT01662999|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal(LLN); upper limit of normal (ULN); pre-treatment(Pre-Rx). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-Rx >ULN or >1.25*ULN if Pre-Rx <=ULN; aspartate aminotransferase (AST) U/L: >1.25*Pre-Rx if Pre-Rx > ULN or 1.25*ULN if Pre-Rx <= ULN;alanine aminotransferase (ALT) U/L: >1.25*Pre-Rx if Pre-Rx>ULN or 1.25*ULN if Pre-Rx<=ULN;blood urea nitrogen (BUN)mmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.2*Pre-Rx if Pre-Rx >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.25*Pre-Rx if Pre-Rx >ULN;direct bilirubin µmol/L: >1.1*ULN if Pre-Rx <= ULN or >1.25*Pre-Rx if Pre-Rx > ULN; creatine phosphokinase (CK) U/L: >1.5*Pre-Rx if Pre-Rx >ULN or >1.5*ULN if Pre-Rx <= ULN.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
1361642|NCT01662999|Secondary|Mean Change From Baseline in Temperature - Safety Population|Participant had their temperature taken after quietly sitting for at least 5 minutes and it was measured as degrees of centigrade (C). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.|||degrees of centigrade||Standard Deviation|Mean
1361643|NCT01662999|Secondary|Mean Change From Baseline in Respiration Rate - Safety Population|Respiration rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in breaths per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period||||bpm||Standard Deviation|Mean
1361644|NCT01662999|Secondary|Mean Change From Baseline in Heart Rate - Safety Population|Heart rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in beats per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.|||bpm||Standard Deviation|Mean
1361645|NCT01662999|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure - Safety Population|Blood pressure was taken while the participant was quietly seated for at least 5 minutes. Blood pressure was measured in millimeters of mercury (mmHg). Baseline was Day -1 in Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.|||mmHg||Standard Deviation|Mean
1361646|NCT01662999|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal (LLN); upper limit of normal (ULN); pretreatment(pre-RX); treatment (RX). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (vol): <0.85*pre-RX; erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN; neutrophils+bands (*10^9 c/L): <0.85*Pre-RX if Pre-RX <1.5 or <1.5 if Pre-RX >=1.5; eosinophils (*10^9 c/L): if value >0.75; basophils (*10^9 c/L): if value >0.4; monocytes (*10^9c/L): if value >2; lymphocytes (*10^9 c/L): if value <0.750 or if value >7.50.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
1361647|NCT01662999|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, or Discontinuations Due to Adverse Events - Safety Population|Adverse event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. End of study was approximately 16 days and was the time for a participant to conclude each of the 3 periods (including the 6 day washout between periods).|Day 1 to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
1361648|NCT01662999|Secondary|Metabolite to Parent Molar Ratios (MR) of Cmax, AUC(INF), and AUC(0-T) of 5-OH Saxagliptin and Saxagliptin From a Single Dose 5 mg Saxagliptin Versus MR of Saxagliptin and 5-OH When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Saxagliptin is the parent drug and 5-OH saxagliptin is the metabolite. The molecular weights to be used for the molar ratios were 315.42 and 331.42 for saxagliptin and 5-OH, respectively. Plasma samples were analyzed for saxagliptin and for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL and 0.200 ng/mL to 100.0 ng/mL for saxagliptin and 5-OH, respectively).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||Molar ratio||Geometric Coefficient of Variation|Geometric Mean
1361649|NCT01662999|Secondary|Half-life (T-HALF) of Saxagliptin, and 5-OH Saxagliptin From Single Dose 5 mg Saxagliptin Versus T-HALF of Saxagliptin and 5-OH From Co-administered Saxagliptin With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours (h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||h||Standard Deviation|Mean
1361650|NCT01662999|Secondary|Tmax of Saxagliptin, 5-OH Saxagliptin, Saxagliptin Total Active Moiety From a Single Dose of Saxagliptin Versus Tmax of Saxagliptin, 5-OH, Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin and 5-OH by LC-MS/MS using a validated method. Tmax was derived from the plasma concentration versus time profile for study drug and was measured in hours (h). Saxagliptin was the drug, 5-OH saxagliptin was the metabolite, and Saxagliptin total Active Moiety was molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||h||Full Range|Median
1361651|NCT01662999|Secondary|AUC(INF) and AUC(0-T) of the Saxagliptin Total Active Moiety From a Single Dose 5 mg Saxagliptin Versus AUC(INF) and AUC(0-T) of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. AUC(INF) is area under the plasma concentration-time curve from time zero extrapolated to infinity; AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) and both were derived from the plasma concentration versus time profile using a validated PK analysis program ™. Total moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin), AUC(0-T)and AUC(INF) were measured in nano Molars*hours (nM*h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
1361652|NCT01662999|Secondary|Cmax of the Saxagliptin Total Active Moiety From a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Cmax of saxagliptin total active moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin) was derived from the plasma concentration versus time profile for the saxagliptin total active moiety. Measurement was in nano Molars (nM).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||nM||Geometric Coefficient of Variation|Geometric Mean
1361653|NCT01662999|Secondary|AUC(INF) of 5-OH Saxagliptin From a Single Dose Saxagliptin Versus AUC(INF) of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1361654|NCT01662999|Secondary|AUC(0-T) of 5-OH Saxagliptin From Single Dose Saxagliptin Versus AUC(0-T) of 5-OH From Saxagliptin Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method)and was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™. AUC (0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1361655|NCT01662999|Primary|AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1361656|NCT01662999|Primary|AUC(0-T) of Saxagliptin From Single Dose 5 mg Saxagliptin Versus AUC(0-T) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography–Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(0-T), the area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1361657|NCT01662999|Secondary|Cmax of 5-Hydroxy (5-OH) Saxagliptin From a Single Dose Saxagliptin Versus Cmax of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). Actual sampling times were used for PK calculations. Cmax for 5-OH Saxagliptin (the major active metabolite of Saxagliptin) was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in ng/mL.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361658|NCT01662999|Secondary|Plasma Apparent Clearance (CLT/F) of a Single Dose of Dapagliflozin Versus CLT/F of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. CLT/F was calculated as Dose/AUC(INF)and was measured in milliliters per minute (mL/min).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1361659|NCT01662999|Primary|Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography–Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). Cmax for Saxagliptin was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in nanograms per milliliter (ng/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361660|NCT01662999|Secondary|Half-life (T-HALF) of Dapagliflozin From a Single Dose of Dapagliflozin Versus T-Half of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.|||hours||Standard Deviation|Mean
1361668|NCT01662986|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.~Time to the next adverse clinical outcome event from the Two Twin Trials, present 205.478 (NCT01662986) and 205.477 (NCT01663987) was not analysed, only Kaplan Meier curve was plotted. So this endpoint has not been disclosed.~This endpoint was analysed using combined data, as specified in the analysis plan"|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477 : This set includes all patients who were randomized and took at least one dose of the study drug, 157 patients (79 tiotropium and 78 placebo) were included in this set.|||Percentage of participants|||Number
1370773|NCT01560260|Primary|Response Rate (CR or PR) Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1||At 6 months|Thirteen patients were still receiving linsitinib at 6 months.|||participants|||Number
1361661|NCT01662999|Primary|Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus AUC(0-T) for Dapagliflozin When Co-administered With 5 mg Saxagliptin|AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method). Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(0-T) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1361662|NCT01662999|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus Tmax of Dapagliflozin When Co-administered With 5 mg Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. Tmax was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.|||hours||Full Range|Median
1361663|NCT01662999|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|AUC(INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. Serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(INF) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1361664|NCT01662999|Primary|Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population|The geometric mean of the maximum observed plasma concentration (Cmax) is presented below; serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h,and 60 h postdose, relative to dosing on Day 1 in each cross over period and these data are summarized in the Pharmacokinetic (PK) parameter of Cmax presented here. Plasma samples were analyzed for dapagliflozin by High Performance Liquid chromatography–Mass Spectrometry (HPLC-MS/MS) using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Dapagliflozin Cmax was derived from plasma concentration versus time data using a non-compartmental method, using a validated PK analysis program ™. Actual sampling times were used for PK calculations. Cmax was reported in ng/mL.|Day 1 (0 h to 60 h post dose) in each period|Pharmacokinetic (PK) Evaluable: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1361665|NCT01662986|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Time to event: Time to recovery (EXACT-PRO) was not analysed, only Kaplan Meier curve was plotted.~Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day’s score was transformed to the mean score using a rolling 3-day average."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|||||||
1361666|NCT01662986|Secondary|Exposure of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of all-cause hospitalization was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.|||patient years|||Number
1361667|NCT01662986|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.|||hospitalizations per patient year|||Number
1361669|NCT01662986|Secondary|Exposure of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of COPD was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.|||Patient years|||Number
1361670|NCT01662986|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.|||exacerbations per patient year|||Number
1361671|NCT01662986|Secondary|Percentage of Patients With 30-day Hospital Readmission Rates Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with 30-day hospital readmission rates outcome events was analysed.~Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.~The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS."|from date of hospital discharge prior to randomization upto readmission days >1 and <31 days|Treated Set of the pooled twin studies 205.478 and 205.477|||percentage of participants|||Number
1361672|NCT01662986|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.~All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures.~Hospitalizations occurring on the same day as discharge were not considered a separate admission."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477|||percentage of participants|||Number
1361673|NCT01662986|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with COPD exacerbation on study was analysed for the combined study.~A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following:~1) Shortness of breath; 2) Sputum production (volume) ; 3) Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness.~Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.~A required change in treatment included either prescription of antibiotics and/or systemic steroids; and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines and PDE4-inhibitors)."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477|||percentage of participants|||Number
1361674|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.|||Litres||Standard Deviation|Mean
1361675|NCT01662986|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.|||Litres||Standard Deviation|Mean
1361676|NCT01662986|Secondary|Percentage of Patients With Adverse Clinical Event During on Study.|Percentage (number) of patients with adverse clinical event on study, which is defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set (TS)|||percentage of participants|||Number
1361677|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug.|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|baseline and 12 weeks|Treated Set (TS). The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.|||Litres||Standard Deviation|Mean
1361678|NCT01662986|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug.|"Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and 12 weeks|Treated Set (TS): The treated set included all patients randomized and who took at least one dose of the study drug. The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.|||Litres||Standard Deviation|Mean
1361679|NCT01662908|Secondary|Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel||Baseline to final visit (Day 14-21)|mITT|||Participants|||Count of Participants
1361680|NCT01662908|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death|Initial dose of study drug up to 3 days after last dose|Adjudicated confirmed events in the mITT population|||Participants|||Count of Participants
1394939|NCT01311024|Secondary|Invasive Pneumococcal Disease|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
1361683|NCT01662908|Primary|Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]|Thrombus Volume (mm^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated|Baseline to final visit (Day 14-21)|Modified intention to treat (mITT), defined as intention to treat minus the one patient who did not take the investigational product|||percentage of change||Standard Deviation|Mean
1361684|NCT01662882|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection||||SUVR||Standard Deviation|Mean
1361685|NCT01662882|Primary|Qualitative Amyloid Image Assessment|Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection||||participants|||Number
1361686|NCT01662856|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||percent of subjects|||Number
1361687|NCT01662856|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:~At 5 minutes following start of study treatment~At 7 minutes following start of study treatment~At 10 minutes following start of study treatment"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
1361688|NCT01662856|Secondary|Time to Hemostasis (TTH)|"Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.~In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated.~All calculations were performed using SAS PROC LIFETEST"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||minutes||95% Confidence Interval|Median
1361689|NCT01662856|Primary|Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
1361690|NCT01662791|Secondary|Paffenbarger Physical Activity Questionnaire (PPAQ)|"The PPAQ is a validated, self-administered questionnaire that asks for a recall of physical activity of physical activity over the previous 1-week. From the answers to the questions, a physical activity index (PAI) can be computed, providing an estimate of energy expenditure in kcal/week.~The PAI can be estimated using a list of the physical activities a person performs within a time period and the amount of time spent on each activity, e.g. walking to work, light housework, swimming, carrying bricks at work, or whatever applies to an individual person. There is a value called the physical activity ratio for each activity. The list of activities is used to find the relevant values of physical activity ratios, then an overall physical activity level value for the time period is calculated, using time-weighted averages of the physical activity ratios.~This assessment was only measured at baseline."|Baseline||||kcal/week||Standard Deviation|Mean
1361691|NCT01662791|Secondary|Weight Change in Case Group After Treatment|Weight change after treatment|baseline, 3 months||||participants|||Number
1361692|NCT01662791|Other Pre-specified|Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)|"The FFQ is a validated, self-administered semi-quantitative questionnaire used to assess differences in macronutrient, and energy intake. It was designed to provide estimates of usual and customary dietary intake. This questionnaire contains a food list of about 70 food items.~A Food Frequency Questionnaire (FFQ) is a limited checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed over a specified period of time. Semi-quantitative FFQs collect portion size information as standardized portions or as a choice of portion sizes. Calculations for nutrient intake or calories can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient or calories in a serving of that food."|Baseline||||Calories||Standard Deviation|Mean
1361693|NCT01662791|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a self-administered 14-item questionnaire (seven for anxiety and seven for depression) Items are rated on a 4-point scale from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The cut-offs used for identifying significant psychiatric distress was >/= 8. This assessment was only measured at baseline|Baseline||||units on a scale||Standard Deviation|Mean
1361694|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|baseline, 3 months||||units on a scale||Standard Deviation|Mean
1365023|NCT01625845|Secondary|Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||mg/L||Standard Error|Mean
1361695|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI)|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
1361696|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1361697|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39)|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|baseline||||units on a scale||Standard Deviation|Mean
1361698|NCT01662791|Primary|Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)|SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane.|Baseline to 2 hours||||participants|||Number
1361699|NCT01662765|Other Pre-specified|Costs|from initial treatment to the complete healing, all kind of cost will be calculated.|two year||||USD dollars||Standard Deviation|Mean
1361700|NCT01662765|Secondary|Visual Analogue Scale for Patient Satisfaction (VAS-PS)|Well-being and satisfaction scales comprised linear metric scales known as “visual analogue scales,” with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).|30 days||||units on a scale||Standard Deviation|Mean
1361701|NCT01662765|Secondary|Healing Time|the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.|two year||||days||Standard Deviation|Mean
1361702|NCT01662765|Primary|Cure Rate|"Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure.~Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy."|2 year after initial treatment|Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed|||participants|||Number
1361703|NCT01662648|Secondary|Number of Participants Within Each Category of Patient Satisfaction Score|Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure and n signifies those participants who were evaluated for this measure at specified time point."|||participants|||Number
1361704|NCT01662648|Secondary|Change From Baseline in Daytime Drowsiness at Week 26|"Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: not at all to 100:all the time). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."|||millimeter (mm)||Standard Deviation|Mean
1361713|NCT01662583|Secondary|Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.||by 42 days after dose of first vaccination|One patient in the plain text message arm was removed for this analysis because they received the second dose too early and was not re-vaccinated|||percentage of participants|||Number
1361714|NCT01662583|Primary|Receipt of 2nd Dose of the Influenza Vaccine.||by April 30th after receipt of first dose (up to 8 months)||||percentage of participants|||Number
1361705|NCT01662648|Secondary|Change From Baseline in Sleep Quality at Week 26|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: very badly to 100: very well). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."|||millimeter (mm)||Standard Deviation|Mean
1361706|NCT01662648|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."|||units on a scale||Standard Deviation|Mean
1361707|NCT01662648|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1361708|NCT01662648|Secondary|Change From Baseline in PANSS Total Negative Subscale Score at Week 26|The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1361709|NCT01662648|Secondary|Change From Baseline in PANSS Total Positive Subscale Score at Week 26|The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1361710|NCT01662648|Secondary|Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||percentage of participants|||Number
1361711|NCT01662648|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1361712|NCT01662635|Primary|FISH, IHC, RT-qPCR Comparison|200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.|TWO YEARS|The only selection criteria of our subjets was the availability of tumor tissue to perform tests.|||participants|||Number
1361715|NCT01662531|Secondary|Consumption of rIX-FP During Routine Prophylaxis|Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.|12 months|Efficacy Population|||IU/kg/month||Standard Deviation|Mean
1361716|NCT01662531|Secondary|Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis|For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis|Approximately 12 months|Efficacy Population|||bleeding episodes|||Number
1361717|NCT01662531|Secondary|Number of Subjects Developing Antibodies Against rIX-FP|Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).|12 months|Safety Population|||participants|||Number
1361718|NCT01662531|Secondary|Number of Subjects With Treatment-related Adverse Events||12 months|Safety Population|||participants|||Number
1361719|NCT01662531|Primary|Number of Subjects Developing Inhibitors to Factor IX (FIX)|Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.|12 months|Safety Population|||participants|||Number
1361720|NCT01662531|Primary|Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population|||mL/hr/kg||Standard Deviation|Mean
1361721|NCT01662531|Primary|Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)|"AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.~FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values."|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population|||IU*hr/dL||Standard Deviation|Mean
1361722|NCT01662531|Primary|Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population|||hours||Standard Deviation|Mean
1361723|NCT01662531|Primary|Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.|30 minutes after infusion|PK Population|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1361724|NCT01662505|Secondary|Remission Duration|The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi.|From first administration of trial drug up to 486 days|Treated Set, patient with remissions|||Days||Standard Deviation|Mean
1361725|NCT01662505|Secondary|Best Response by PR|"The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the PR is presented.~The criteria for the PR are:~All haematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%."|From first administration of trial drug up to 486 days|Treated Set|||Participants|||Number
1361726|NCT01662505|Secondary|Best Response by CRi|"The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the CRi will be presented.~The criteria for the CRi are:~All CR criteria are met except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100 000/μL])."|From first administration of trial drug up to 486 days|Treated Set|||Participants|||Number
1361727|NCT01662505|Primary|MTD of Volasertib|Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the MTD is presented.|From first administration of trial drug up to 28 days|Treated Set|||milligram (mg)|||Number
1361728|NCT01662505|Secondary|Best Response by Complete Remission (CR)|"The secondary outcome best response will be presented by the CR, CR with incomplete blood count recovery (CRi) and partial remission (PR).~In this outcome measure the CR will be presented.~The criteria for the CR are:~Bone marrow blasts less than 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) >1.0 × 10^9/Litre (L) (1000/microlitre (μL)); platelet count >100 × 10^9/L (100 000/μL); independence of red cell transfusions."|From first administration of trial drug up to 486 days|Treated Set|||Participants|||Number
1361729|NCT01662505|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib|Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the number of participants with DLTs in cycle 1 is presented.|From first administration of trial drug up to 28 days|Treated Set|||Participants|||Number
1361730|NCT01662492|Secondary|Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment|Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.|12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Percentage of participants|||Number
1361731|NCT01662492|Secondary|Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days|Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Percentage of participants|||Number
1361793|NCT01662102|Secondary|Quality of Life (QoL)|QoL will be assessed through EORTC FACT-G and QLQ-[C]30 questionnaires, and will be compared at each specified time point between treatment arms.|Up to 7 years|||||||
1361732|NCT01662492|Secondary|Change From Baseline in the Total Cumulative Hours of Headache on Headache Days|Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Cumulative hours of headache||Standard Deviation|Mean
1361733|NCT01662492|Secondary|Change From Baseline in the Frequency of Severe Headache Days|Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Severe Headache Days||Standard Deviation|Mean
1361734|NCT01662492|Primary|Change From Baseline in the Frequency of Headache Days|Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Headache days||Standard Deviation|Mean
1361735|NCT01662440|Secondary|Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57|Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.|Day 1 through Day 57|Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.|||Number of subjects|||Number
1361736|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination|Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.|Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.|||Number of Subjects|||Number
1361737|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection|Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R – Conv and JE – Conv groups), day 4 through day 10 (injection on day 4; in R/JE – Conv, R – Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE – Conv, R – Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE – Acc, R – Con and JE – Conv groups).|Day 1 through day 7 after each injection (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.|||Number of Subjects|||Number
1361738|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination|Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE – Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE – Con and JE – Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 8 and 29)|Analysis was done on the solicited safety set.|||Number of subjects|||Number
1361739|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination|Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE – Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE – Conv and R – Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)|Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.|||Number of subjects|||Number
1361740|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as PRNT50 GMTs|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)|Analysis was done on the PP dataset.|||Titers||95% Confidence Interval|Geometric Mean
1361741|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Days 1, 15, 22, 36, 57, 91, 181 and 366|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
1361742|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as the RVNA GMCs|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181, and 366|Analysis was done on the PP dataset.|||IU/mL||95% Confidence Interval|Geometric Mean
1361743|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181 and Day 366|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
1361744|NCT01662440|Secondary|Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.~As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs JE – Conv."|Day 15 and day 36 (28 after last active vaccination)|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
1361745|NCT01662440|Secondary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.~As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs R – Conv."|Day 36 and day 57 (28 days after last active vaccination)|Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
1361746|NCT01662440|Secondary|PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination|"Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.~Data were adjusted using ANOVA model, as per protocol specifications."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.|||Titers||95% Confidence Interval|Geometric Mean
1361747|NCT01662440|Secondary|RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination|"Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.~Data were adjusted using ANOVA model, as per protocol specification."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.|||IU/mL||95% Confidence Interval|Geometric Mean
1361748|NCT01662440|Primary|Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.~As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs JE – Conv."|Day 28 after last active vaccination (day 36 – group that received accelerated schedule, day 57 – group that received conventional schedule)|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
1361749|NCT01662440|Primary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.~As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE – Acc Vs R – Conv."|Day 7 after last active vaccination (day 15 – group that received accelerated schedule, day 36 – group that received conventional schedule)|Analysis was done on the per-protocol (PP) dataset, ie, the subjects who received the vaccine correctly, provided evaluable serum samples at the relevant time points, and had no major protocol violations as defined prior to unblinding.|||Percentages of subjects||95% Confidence Interval|Number
1361750|NCT01662362|Secondary|ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas||Up to six months||||percentage of specimens ESA negative||95% Confidence Interval|Number
1361751|NCT01662362|Primary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas||Up to six months||||percent agreement to RIPA||95% Confidence Interval|Number
1361752|NCT01662336|Secondary|Healthcare Provider Satisfaction|For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.|Month 6 and Month 12|Intent-to-treat population with non-missing data at each time point|||units on a scale||Standard Deviation|Mean
1361753|NCT01662336|Secondary|Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit||Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at each time point|||cells/mm³||Standard Deviation|Mean
1361754|NCT01662336|Secondary|Viral Load at Each Visit||Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||copies/mL||Standard Deviation|Mean
1361755|NCT01662336|Secondary|Health Resource Utilization|Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient’s utilization of healthcare resources and economic impact of the disease.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at each time point.|||percentage of participants|||Number
1361756|NCT01662336|Secondary|Change From Baseline in Coping Self-Efficacy|Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361757|NCT01662336|Secondary|Change From Baseline in Psychological Well-being|Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361758|NCT01662336|Secondary|Change From Baseline in Patient Perception of Stress|Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361794|NCT01662102|Secondary|Transformation at First Progression|Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.|Up to 7 years|||||||
1373640|NCT01525407|Secondary|Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity||Until completion of stem cell collection (on average 14 days)||||Participants|||Count of Participants
1361759|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361760|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Mental Health Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361761|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Pain Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361762|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361763|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Social Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361764|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Role Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361765|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361766|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life General Health Perception Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
1361795|NCT01662102|Secondary|Overall Response Rate (ORR)|Tumor response will be evaluated according to Cheson criteria at the time of randomization and at the end of the 2-year maintenance/observation, post randomization. ORR is defined as the proportion of patients with a CR or a PR, and will be compared between treatment groups. Patients with no response evaluation (for any reason) will be considered as not evaluable (NE).|Up to 7 years|||||||
1361767|NCT01662336|Secondary|Percentage of Participants Adherent to Treatment at Month 12|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient’s confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.|Baseline and 12 months|The intent-to treat population; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
1361768|NCT01662336|Secondary|Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient’s confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||units on a scale||Standard Deviation|Mean
1361769|NCT01662336|Secondary|Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12|"Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient’s confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).~The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy."|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||units on a scale||Standard Deviation|Mean
1361770|NCT01662336|Secondary|Change From Baseline in Adherence Summative Score at Months 6 and 12|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant’s confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||units on a scale||Standard Deviation|Mean
1361771|NCT01662336|Primary|Percentage of Participants Adherent to Treatment at Month 6|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient’s confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.|Baseline and 6 months|The intent-to treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
1361772|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1361773|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1361796|NCT01662102|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause. In living patients, survival time will be censored on the last date patients were known to be alive.|Up to 7 years|||||||
1361797|NCT01662102|Secondary|Time to Next Chemotherapy (TTNCT)|TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Patients who respond to treatment and patients who are lost to follow-up will be censored at the visit on which the dosing of a new medication was evaluated.|Up to 7 years|||||||
1361774|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1361775|NCT01662310|Secondary|Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).|DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).|||Days||95% Confidence Interval|Median
1361776|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."|||Millimeter (mm)||Standard Deviation|Mean
1361777|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."|||Millimeter (mm)||Standard Deviation|Mean
1361778|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."|||Millimeter (mm)||Standard Deviation|Mean
1361779|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."|||Millimeter (mm)||Standard Deviation|Mean
1361780|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.|||Units on a scale||Standard Deviation|Mean
1361798|NCT01662102|Secondary|Time to Next Anti-Lymphoma Treatment (TTNLT)|TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.|Up to 7 years|||||||
1361799|NCT01662102|Secondary|Time to Progression (TTP)|TTP is defined as the time from randomization to the first disease progression.|Up to 7 years|||||||
1361781|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."|||Units on a scale||Standard Deviation|Mean
1361782|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.|||Units on a scale||Standard Deviation|Mean
1361783|NCT01662310|Secondary|Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point."|||Participants|||Number
1361784|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
1361785|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values."|||Units on a scale||Standard Deviation|Mean
1361786|NCT01662310|Primary|Double Blind (DB) Phase: Median Time to Relapse|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.|DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Days||95% Confidence Interval|Median
1361787|NCT01662115|Secondary|Use of NG Tubes|Nasogastric tube (re)insertions|30 days||||NG Tubes use||Full Range|Mean
1361788|NCT01662115|Secondary|Post-operative Vomiting|Episodes of vomiting|30 days||||vomiting episodes||Full Range|Mean
1361789|NCT01662115|Secondary|Hospital Stay|Length of postoperative hospital stay|30 days||||days||Full Range|Mean
1361790|NCT01662115|Primary|Bowel Function Recovery|Time to first bowel movement or flatus|7 days||||days||Full Range|Mean
1361791|NCT01662102|Primary|Progression Free Survival|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.|24 months|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.||||||
1361792|NCT01662102|Secondary|Pharmacoeconomics (Cost Effectiveness Analysis)|A cost-effectiveness analysis will be done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis will be conducted according to a health economic analysis plan independent from this clinical study protocol.|Up to 24 months|||||||
1361802|NCT01662063|Secondary|Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||percentage of participants|||Number
1361803|NCT01662063|Secondary|Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||participants|||Number
1361804|NCT01662063|Secondary|Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||percentage of participants|||Number
1361805|NCT01662063|Secondary|Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||participants|||Number
1361806|NCT01662063|Secondary|Percentage of Participants With HAQ-DI Score <0.5|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score <0.5 was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||percentage of participants|||Number
1361807|NCT01662063|Secondary|Change From Baseline in HAQ-DI Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1361808|NCT01662063|Secondary|Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1361838|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|Baseline|Safety Population; only participants with a valid assay at Screening were included.|||percentage of participants|||Number
1365024|NCT01625845|Secondary|Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||pg/mL||Standard Error|Mean
1361809|NCT01662063|Secondary|Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||mm||Standard Deviation|Mean
1361810|NCT01662063|Secondary|Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||mm||Standard Deviation|Mean
1361811|NCT01662063|Secondary|Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||mm||Standard Deviation|Mean
1361812|NCT01662063|Secondary|Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||mm||Standard Deviation|Mean
1361813|NCT01662063|Secondary|Time to Return to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included.|||weeks||Full Range|Median
1361814|NCT01662063|Secondary|Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen were included.|||participants|||Number
1361815|NCT01662063|Secondary|Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).|||percentage of participants|||Number
1361816|NCT01662063|Secondary|Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).|||participants|||Number
1361817|NCT01662063|Secondary|Percentage of Reasons Given for CCS Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation >14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS discontinuation >14 days were included.|||percentage of reasons|Participants||Number
1361818|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Interruption|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption.|||percentage of reasons|Participants||Number
1361865|NCT01661790|Secondary|Median Progression Free Survival (PFS)||baseline to biweekly,until disease progression|||||||
1362053|NCT01660022|Primary|OZ439 t1/2|OZ439 Elimination half-life|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||hour||Geometric Coefficient of Variation|Geometric Mean
1361819|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Reduction|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose reduction were included.|||percentage of reasons|Participants||Number
1361820|NCT01662063|Secondary|Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.|||percentage of participants|||Number
1361821|NCT01662063|Secondary|Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.|||participants|||Number
1361822|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD discontinuation >60 days were included.|||percentage of reasons|Participants||Number
1361823|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Dose Reduction or Interruption|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included.|||percentage of reasons|Participants||Number
1361824|NCT01662063|Secondary|Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.|||percentage of participants|||Number
1361825|NCT01662063|Secondary|Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.|||participants|||Number
1361826|NCT01662063|Secondary|Change From Baseline in SJC Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||swollen joints||Standard Deviation|Mean
1361827|NCT01662063|Secondary|Swollen Joint Count (SJC) Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||swollen joints||Standard Deviation|Mean
1361828|NCT01662063|Secondary|Change From Baseline in TJC Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||tender joints||Standard Deviation|Mean
1361829|NCT01662063|Secondary|Tender Joint Count (TJC) Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||tender joints||Standard Deviation|Mean
1361867|NCT01661764|Other Pre-specified|Insulin Sensitivity|"homeostasis model assessment-insulin resistance (HOMA-IR) HOMA-IR. Fasting insulin and glucose were be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5], Optimal insulin sensitivity: < 1, Early insulin resistance: > 1.9, Significant insulin resistance: > 2.9"|6 months||||HOMA-IR Index||Standard Deviation|Mean
1361830|NCT01662063|Secondary|Change From Baseline in SDAI Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1361831|NCT01662063|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1361832|NCT01662063|Secondary|Change From Baseline in CDAI Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1361833|NCT01662063|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1361834|NCT01662063|Secondary|Change From Baseline in DAS28 Score|The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1361835|NCT01662063|Secondary|Disease Activity Score Based on 28 Joints (DAS28) Score|The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1361836|NCT01662063|Secondary|Percentage of Participants Who Correctly Administered All SC TCZ Doses|Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (>) 8 hours, and absence of other medication errors.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.|||percentage of participants|||Number
1361837|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.|From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.|||percentage of participants|||Number
1361839|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.|||percentage of participants|||Number
1361840|NCT01662063|Primary|Percentage of Participants With at Least One SAE|AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.|||percentage of participants|||Number
1361841|NCT01662063|Primary|Number of Participants With at Least One Serious Adverse Event (SAE)|Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.|||participants|||Number
1361842|NCT01662024|Secondary|Waist Circumference Loss (cm)|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)|12 Months||||cm||Full Range|Mean
1361843|NCT01662024|Secondary|BMI Loss (kg/m^2)|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)|12 Months||||kg/m^2||Full Range|Mean
1361844|NCT01662024|Secondary|Percentage of Total Body Weight Loss|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss|12 Months||||Percentage of total weight lost||Full Range|Mean
1361845|NCT01662024|Secondary|Durability|Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.|12 months|Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.||||||
1361846|NCT01662024|Secondary|Percent Excess Weight Loss|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss|12 Months||||Percentage of excess weight lost||Full Range|Mean
1361847|NCT01662024|Primary|Evaluation of Technical Feasibility of the Procedure|Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.|Day 0 - Procedure Day||||Sutures||Full Range|Mean
1361848|NCT01662024|Primary|Number of Participants With Adverse Events|Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.|12 months||||Participants|||Count of Participants
1361849|NCT01661972|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|Subjects will be followed until death which is estimated to be on average 6 months - 1 year after coming off protocol therapy|Patients enrolled in Phase 2 were included in the analysis|||months||95% Confidence Interval|Median
1361850|NCT01661972|Secondary|Response Rate|The percentage of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.|approximately every 9 weeks and/or restaging, through study completion|All evaluable Phase 2 patients. 5 patients were not evaluable for response and were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1361851|NCT01661972|Primary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. Per RECIST criteria, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|approximately 5 months|Patients enrolled in Phase 2 were included in the analysis|||Months||95% Confidence Interval|Median
1361866|NCT01661790|Primary|"Number of Participants With Complete Response and Partial Response"|Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR|from randomization, This treatment was given every two weeks,responses were made by biweekly||||participants|||Number
1361868|NCT01661764|Other Pre-specified|Adipokines|leptin and adiponectin|6 months|Adipokines were not measured on all trial participants due to assay expense. Samples measurements were not completed on 3 GG, fish oil, 0 GG, placebo, 3 GT fish oil, 4 GT placebo, 7 TT fish oil, 9 TT placebo|||ng/mL||Standard Deviation|Mean
1361852|NCT01661972|Primary|Number of Dose-Limiting Toxicities (Phase 1)|"Number of patients experiencing a dose-limiting toxicity in each cohort.~A dose-limiting toxicity is defined as Grade 4 neutropenia, thrombocytopenia or anemia or grade 3 neutropenia or thrombocytopenia lasting over 7 days Grade 3 thrombocytopenia associated with bleeding Febrile Neutropenia Nausea/Vomiting or Diarrhea ≥ grade 3 and lasting ≥ 4 days despite adequate supportive measures Grade ≥ 3 Bilirubin, ALT or AST > 7 days Other non-hematologic toxicity ≥ grade 3 excluding alopecia, anorexia, fatigue, hypertension, isolated lab abnormalities (not clinically significant) and/ rare, idiosyncratic reactions to any of the study drugs. Anorexia, fatigue and hypertension will be considered as DLT only if they reach grade 4 or are considered unmanageable Treatment delay of ≥ 14 days for cycle 2 due to unresolved toxicity Treatment-related death or clinically significant,treatment-related hospitalization"|28 days||||Participants|||Count of Participants
1361853|NCT01661972|Primary|Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination|Phase 1 of this study will be the dose escalation component to determine safety and the Recommended Phase II dose (RPTD) for the capecitabine plus aflibercept combination. Cohort 1 will receive 850mg/m2 capecitabine and 6mg/kg aflibercept. If less than 2 of 6 patients experience a dose limiting toxicity in Cohort 1, then the next patients will be enrolled in Cohort 2 at 1000mg/m2 capecitabine and 6mg/kg aflibercept. RPTD is determined by the number of dose limiting toxicities (Primary obj 2 for Phase I).|RPTD for the study will be determined at the completion of Phase I; up to 1 year.||||mg/m2|||Number
1361854|NCT01661933|Secondary|Serum Anti-tissue Transglutaminase Antibodies Measured as International Units/mL (IU/mL)|The trial was extended with pre-trial and mid-trial anti-tTG antibody levels used to compare with the post-trial levels. Anti-tTG is a serological measure of tissue transglutaminase-2 antibodies. In active celiac disease, levels are increased. In treated disease, levels are low (normal cut-off was <15 IU/mL). A significant increase compared to baseline in tTG can be expected 2 weeks after consuming 3g of gluten daily for 2 weeks in people with celiac disease who have been maintaining a gluten-free diet, but who are not taking other treatment.|Anti-tTG IU/mL levels pre-trial, mid-trial and after 3 gram/day gluten challenge|2 of 12 participants did not progress past baseline micro-challenge, 2 of 10 participants did not progress past low-dose challenge.|||International Units/mL||95% Confidence Interval|Mean
1361855|NCT01661933|Secondary|Number of Participants With 2 Points Increase in Marsh Score Post GC-1g|The Marsh score is a defined but qualitative assessment assigned a value to allow for comparison. The scores were evaluated by consensus between the primary (chief) investigator and the study pathologist. The Marsh score was graded 0, 1, 2, 3A (assigned-4), 3B (-5) and 3C (-6); rage 1-6 with normal=0 and severe inflammation=6. Because the scoring is vulnerable to artefact, only a 2-point shift was regarded as a significant intra-individual change. The scores were graded after week-36 on biopsies de-identified shuffled. An upward shift was interpreted to reflect a significant worsening of gluten-associated inflammation. The comparison reported evaluated changes from baseline (week-24) to post-low-dose gluten challenge (week-24; GC-1g). The objective for using the Marsh score was to identify individuals who might have experienced a severe worsening in pathology due to GC-1g that might not be reflected in the Vh:Cd group analysis.|Longitudinal change between week-24 and week-36|The outcome score was the number with a 2-point increase in Marsh 3 score post GC-1g.|||participants|||Number
1361856|NCT01661933|Secondary|Intraepithelial Lymphocyte Count|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with anti-CD3. All slides were de-identified and graded by Dr John Croese. The IEL percentages were measured on 2 or more randomly selected well-orientated villi. The null hypothesis is that hookworm infection will not protect against mucosal IEL influx following 12-week exposure to gluten in celiac disease.|Week-24 and -36||||Percentage of epithelial cells||95% Confidence Interval|Mean
1361857|NCT01661933|Primary|Duodenal Villus Height:Crypt Depth|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with H&E. Slides from both time-points were de-identified, shuffled and graded by Dr John Croese after which results from poorly orientated slides were verified by Dr Andrew Clouston. The Vh:Cd ratios were measured on 5 randomly selected well-orientated sites. The null hypothesis is that hookworm infection will not protect against mucosal damage following 12-week exposure to gluten in celiac disease.|Week -24 to -36|All 10 of 12 participants who completed micro-challenge successfully progressed and completed low-dose challenge.|||Ratio||95% Confidence Interval|Mean
1361858|NCT01661881|Secondary|Autologous Stem Cell Transplant (ASCT) Rate|ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)|All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction.||||proportion of participants||90% Confidence Interval|Number
1361859|NCT01661881|Secondary|1 Year Progression-Free Survival|1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).|Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months.|The analysis dataset is comprised of all enrolled patients.|||probability||90% Confidence Interval|Number
1361860|NCT01661881|Primary|Complete Remission (CR) Rate After 6 Cycles|The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.|Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.|The analysis dataset is comprised of all enrolled patients.|||proportion of participants||90% Confidence Interval|Number
1361861|NCT01661790|Other Pre-specified|Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)||before intrapleural administration|||||||
1361862|NCT01661790|Secondary|Qualify of Life (QoL)||baseline to biweekly,until death|||||||
1361863|NCT01661790|Secondary|Adverse Reactions||Up to 1 month after the last treatment|||||||
1361864|NCT01661790|Secondary|Overall Survival (OS)||randomization to four weeks,until death|||||||
1361870|NCT01661764|Secondary|Rectal Epithelial Cell Production of PGE2 and PGE3|liquid chromatography/tandem mass spectrometric on rectal biopsy samples|6 months|For some participants the volume of frozen tissue was not enough to measure rectal eicosanoids and are not included in the analysis (2 from GG, fish oil, 2 from GG, placebo, 3 from GT fish oil, 4 GT placebo, 1 TT fish oil and 3 TT placebo)|||ng/g||Standard Deviation|Mean
1361871|NCT01661764|Secondary|Rectal Epithelial Cell Phospholipid Fatty Acid Content|Lipids will be extracted using the method of Folch-Lees|6 months|Due to inadequate rectal tissue specimens we were unable to measure rectal tissue phospholipids||||||
1361872|NCT01661764|Secondary|Rectal Epithelial Cell 15-PGDH Expression|Expression of 15-PGDH in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).|6 months||||percentage of cells positive||Standard Deviation|Mean
1361873|NCT01661764|Secondary|Rectal Epithelial Cell COX-2 Expression|Expression of COX-2 in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).|6 months||||percentage of cells positive||Standard Deviation|Mean
1361874|NCT01661764|Primary|Rectal Epithelial Cell Apoptosis|The primary outcome of interest is rectal epithelial cell apoptosis as measured by TUNEL (TdT-mediated dUTP Nick-End Labeling). The TUNEL assay is conducted to measure apoptosis of colon epithelium using DeadEnd Colorimetric TUNEL System (Promega). After all fields of each sample are measured, the final immunoreaction indices are generated automatically by setting algorithms as ‘‘total positive area / total nuclear area. Apoptotic activity is also scored using standard morphologic criteria applied to H&E stained sections.|6 months||||percentage of cells positive||Standard Deviation|Mean
1361875|NCT01661764|Primary|Rectal Epithelial Cell Proliferation|The primary outcome of interest is rectal epithelial cell proliferation, as measured by Ki67 (mib-1) labeling. Expression of Ki-67 in colon epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).|6 month|Patients with before and after rectal biopsies|||percentage of cells positive||Standard Deviation|Mean
1361876|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day|"Efficacy:~Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The IPSS quality of life question score on a 7-point scale ranging from 0 Delighted to 6 Terrible.~IPSS-QoL ranges 0 to 6 (Delighted to Terrible)~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
1361877|NCT01661621|Secondary|The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day|"Efficacy:~Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
1361878|NCT01661621|Secondary|The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day|"Efficacy:~Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
1361879|NCT01661621|Secondary|The Postvoid Residual Volume (PVR) After the Treatment Day|"Efficacy:~Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||mL||Standard Deviation|Mean
1361880|NCT01661621|Secondary|The Voided Volume After the Treatment Day|"Efficacy:~Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||mL||Standard Deviation|Mean
1361881|NCT01661621|Secondary|The Maximum Flow Rate (Qmax) After the Treatment Day|"Efficacy:~Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||mL/s||Standard Deviation|Mean
1361882|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day|"Efficacy:~Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
1361883|NCT01661621|Primary|The Global Response Assessment (GRA) After the Treatment Day|"Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The global response assessment on a 6-point scale ranging from 1 No problems at all to 6 Many severe problems.~Changes of the global response assessment (GRA) improved or reduction by 1 points.~Change = Baseline minus Month 1 value~Safety:~Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness"|1 month after initial treatment||||participants|||Number
1361884|NCT01661595|Other Pre-specified|Hematocrit Level Measured at Week 8|Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.|week 8||||percent of red blood cells||Standard Deviation|Mean
1361890|NCT01661595|Secondary|Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8|Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory – Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.|week 8||||scores on a scale||Standard Deviation|Mean
1361891|NCT01661595|Secondary|Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4|Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory – Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.|week 4|1 subject did not complete the week 4 MFSI questionnaire|||scores on a scale||Standard Deviation|Mean
1361892|NCT01661595|Secondary|Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0|Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory – Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.|Week 0||||scores on a scale||Standard Deviation|Mean
1361893|NCT01661595|Secondary|Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug|Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of active drug|1 subject did not complete the walking test.|||meter||Standard Deviation|Mean
1361894|NCT01661595|Secondary|Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo|Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of placebo|1 subject did not complete the walking test|||meters||Standard Deviation|Mean
1361895|NCT01661595|Secondary|Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.|Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 8||||kilograms||Standard Deviation|Mean
1361896|NCT01661595|Secondary|Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.|Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 4||||kilograms||Standard Deviation|Mean
1361897|NCT01661595|Secondary|Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.|Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 0||||kilograms||Standard Deviation|Mean
1361898|NCT01661595|Secondary|Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.|Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 8||||kilograms||Standard Deviation|Mean
1361899|NCT01661595|Secondary|Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.|Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 4||||kilograms||Standard Deviation|Mean
1361900|NCT01661595|Secondary|Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.|Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 0||||kilograms||Standard Deviation|Mean
1361901|NCT01661595|Secondary|Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of active drug||||Newton-Meters||Standard Deviation|Mean
1361902|NCT01661595|Secondary|Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo.|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of placebo||||Newton-Meters||Standard Deviation|Mean
1361903|NCT01661595|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug.|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of active drug||||Newton-Meters||Standard Deviation|Mean
1361998|NCT01660672|Secondary|Toxicity Related to LVT|Toxicity including vomiting, aspiration, complications related to the NGT, laboratory parameters at 24 hours and 1 week post LVT administration, and an overall acute case fatality rate significantly above the consistent historical ward average for CM. Pk studies to evaluate LVT absorption and elimination in pediatric CM.|1 week||||participants|||Number
1361904|NCT01661595|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of placebo||||Newton-Meters||Standard Deviation|Mean
1361905|NCT01661595|Primary|Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug|The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.|after 4 weeks of active drug||||units on a scale||Standard Deviation|Mean
1361906|NCT01661595|Primary|Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo|The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test after 4 weeks of placebo. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.|after 4 weeks of placebo||||units on a scale||Standard Deviation|Mean
1361907|NCT01661595|Primary|Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug|Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.|after 4 weeks of active drug||||Newton-Meters||Standard Deviation|Mean
1361908|NCT01661595|Primary|Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo|Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.|after 4 weeks of placebo||||Newton-Meters||Standard Deviation|Mean
1361909|NCT01661270|Secondary|Percentage of Participants With Objective Response|Objective response rate was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR), as assessed by Investigators and the IRC according to RECIST 1.0 criteria, relative to the total number of participants in the relevant analysis population. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|26.6 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
1361910|NCT01661270|Secondary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the earliest between the last date of the participants was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|31.6 months|ITT population.|||months||95% Confidence Interval|Median
1361911|NCT01661270|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of first observation of either tumor progression or death due to any cause. Tumor assessment was performed by Independent Review Committee (IRC) as per response evaluation criteria in solid tumors (RECIST) version 1.0. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates.|26.7 months|Intent-to-Treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
1361912|NCT01661205|Secondary|Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores|"Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.~This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.~The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.~Negative change from baseline compared to 12-months represents an improvement in AF symptomatology ."|12 month follow-up||||percentage of from baseline||Standard Deviation|Mean
1361913|NCT01661205|Secondary|Number of Subjects With Direct Current (DC) Cardioversion||12 month follow-up||||Participants|||Count of Participants
1361914|NCT01661205|Secondary|Number of Subjects With Reinterventions||12 month follow-up||||Participants|||Count of Participants
1361915|NCT01661205|Secondary|Number of Subject Without Atrial Fibrillation|AF free with or without the need of antiarrhythmic drugs|6 and 12 month follow-up||||Participants|||Count of Participants
1361916|NCT01661205|Secondary|Number of Subjects With Acute Procedure Success|"Defined as subject meeting all of the following criteria upon completion of the index-EP procedure~Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);~Bi-directional cavotricuspid isthmus block;~Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);~Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed."|Day 0||||Participants|||Count of Participants
1361917|NCT01661205|Secondary|Number Subjects With Serious Device or Procedure Related Adverse Event Rate||12 month follow-up||||Participants|||Count of Participants
1361918|NCT01661205|Primary|Number of Subjects With Absence of Atrial Fibrillation|Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.|12 month follow-up|Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.|||Participants|||Count of Participants
1361919|NCT01661205|Primary|Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.|Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.|30 days post-index procedure or hospital discharge|Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.|||Participants|||Count of Participants
1361920|NCT01661179|Primary|Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib|ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.|Sept 2012 to May 2014|All patients with post-baseline efficacy assessments|||percentage of participants||95% Confidence Interval|Number
1361921|NCT01661140|Secondary|Change in Productivity and Regular Daily Activities Affected by Rheumatoid Arthritis Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Assessments were made using a visual analogue scale ranging from 0 to 10 where 0 = minimum impact and 10 = maximum impact.|Randomization (Week 24), Week 60, 72|Participants in the ITT population with available data at the respective time points were analyzed.|||units on a scale||Full Range|Median
1361922|NCT01661140|Secondary|Hours Actually Worked and Work Hours Missed Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Reported here are hours actually worked, work hours missed due to rheumatoid arthritis (RA), work hours missed due to other reasons and the change from Week 24 for each of these parameters reported at Week 60 and Week 72.|Randomization (Week 24), Week 60, Week 72|Participants in the ITT population with available data were analyzed.|||hours||Full Range|Median
1361923|NCT01661140|Secondary|Number of Subjects Employed Assessed Using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||participants|||Number
1361924|NCT01661140|Secondary|Percentage of Participants Able to Discontinue Methotrexate||Week 0 up to Week 60|Data were not collected for this outcome measure.||||||
1361925|NCT01661140|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any adverse event that can be fatal, life threatening, requires long or prolong hospitalization, results in persistent or significant disability/incapacity, congenital anomaly or significant medical event in the investigator’s judgment.|Week 0 up to Week 72|Safety population included all the randomized participants.|||participants|||Number
1361926|NCT01661140|Secondary|Percentage of Participants With Anemia||Week 0 up to Week 72|Safety population included all the randomized participants.|||percentage of participants|||Number
1361927|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using 12-item Short Form Health Survey [SF-12]) at Week 60 and 72|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in SF-12 score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361928|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-F] at Week 60 and 72|The FACIT-fatigue assessment was a 13-item questionnaire with participants scoring each item on a 5-point scale (not at all; a little bit; somewhat; quite a bit and very much). The total score ranges from 0 to 65 and higher scores indicate more fatigue. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in total FACIT score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361969|NCT01660802|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients|||Percentage of Patients|||Number
1361929|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Health Assessment Questionnaire [HAQ] at Week 60 and 72|The HAQ-disability index (DI) evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of participants with an improvement in HAQ-DI score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361930|NCT01661140|Secondary|Percentage of Participants Who Achieve Simplified Disease Activity Index (SDAI) Remission (SDAI < 3.3) at Week 60 and 72|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361931|NCT01661140|Secondary|Percentage of Participants Who Achieve Clinical Disease Activity Index (CDAI) Remission (CDAI < 2.8) at Week 60 and 72|Clinical Disease Activity Index (CDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + patient global assessment of disease (PGA) 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361932|NCT01661140|Secondary|Percentage of Participants Who Achieve Change in Disease Activity Score (cDAS) >=1.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve cDAS28 >=1.2 score at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361933|NCT01661140|Secondary|Percentage of Participants Who Achieve DAS28 Remission (DAS28 < 2.6)|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve DAS28 remission score <2.6 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361934|NCT01661140|Secondary|Percentage of Participants Who Achieve a Disease Activity Score In 28 Joints (DAS28) <= 3.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve score <=3.2 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361935|NCT01661140|Secondary|Percentage of Participants Who Achieve Score of <=1 in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 60 and 72|Percentage of participants who achieve score of =1 in TJC and SJC at week 60 and 72 were reported. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
1361936|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 72|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 72|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1361937|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 60|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 60|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this end point.|||units on a scale||Standard Deviation|Mean
1361970|NCT01660802|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients|||Letters Read Correctly||Standard Deviation|Mean
1361938|NCT01661140|Primary|Percentage of Participants Maintaining Previous Disease Activity (European League Against Rheumatism [EULAR] Response) From Week 24 (Time of Randomization) to Week 60|Response was determined using EULAR criteria based upon (Disease Activity Score In 28 Joints) DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (<=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'|From randomization to Week 60|Intention to treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1361939|NCT01661114|Secondary|Median Overall Survival of Previously Treated and Previously Untreated Patients|To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin.|1 year|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.|||Months||95% Confidence Interval|Median
1361940|NCT01661114|Primary|The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment|"The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients.~Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|28 days|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.|||percentage of patients||95% Confidence Interval|Number
1361941|NCT01661088|Secondary|Median Overall Survival Time|To estimate overall survival as a function of time from study enrollment.|up to 2 years||||months||95% Confidence Interval|Median
1361942|NCT01661088|Secondary|Median Progression-free Survival Time|To estimate progression-free survival as a function of time from study enrollment. Progression is defined as at least a 20% increase in the LD (longest diameter) of the primary lesion or the appearance of one or more new lesions|up to 2 years||||months||95% Confidence Interval|Median
1361943|NCT01661088|Primary|The Percentage of Patients That Underwent an R0 Resection|To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.|6 months||||percentage of patients|||Number
1361944|NCT01661062|Primary|Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate|Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).|24 months|36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.|||correlation coefficient|||Number
1361945|NCT01661062|Secondary|The Median Delivered Dose of Radiation to the Parotid Gland||7 weeks||||Gy||Full Range|Median
1361946|NCT01661062|Secondary|Improvement of Image Quality|Use acquired data to further improve cone beam CT reconstruction techniques and image quality.|36 months|||||||
1361947|NCT01661062|Primary|Rate of Movement of Normal Tissue|The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.|approximately 7 weeks|||||||
1361948|NCT01660906|Other Pre-specified|Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib|Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. MR4.5, the number of treated participants with BCR-ABL transcripts ≤ 0.0032% (IS) at 6 and 12 months from the date of dasatinib initiation; MMR, Major Molecular Response = 3-log reduction in BCR-ABL gene transcripts from a standardized baseline.|6 and 12 months|All treated participants.|||Participants|||Count of Participants
1361949|NCT01660906|Secondary|The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib|Dasatinib treatment was administered and its impact on the Imatinib-related Grade 1/2 adverse events was assessed. The percentage of participants is based on the number that had pre-existing Imatinib-related AEs. Measure assesses the participants with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after Dasatinib treatment. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method.|3 months|All treated participants.|||percentage of participants||95% Confidence Interval|Number
1361950|NCT01660906|Secondary|Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib.|Date of first dose to 30 post last dose of study drug, an average of 3 years|All treated participants.|||Participants|||Count of Participants
1361971|NCT01660802|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients|||Letters Read Correctly||Standard Deviation|Mean
1361951|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib|The EORTC QLQ-C30 questionnaire is completed by study participants to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represents a healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale and single-item measures represents a high level of problematic symptomatology.|Baseline to 6, 12 months|All treated participants|||units on a scale||Standard Deviation|Mean
1361952|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib|The MD Anderson Symptom Inventory Chronic Myeloid Leukemia (MDASI-CML) is a validated questionnaire completed by study participants to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to Dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely.|Baseline to 3, 6, 12 months|All treated participants.|||units on a scale||Standard Deviation|Mean
1361953|NCT01660906|Primary|The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment|Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased.|3 months after switch to dasatinib|All treated participants.|||adverse event(s)|||Number
1361954|NCT01660893|Secondary|Absolute Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
1361955|NCT01660893|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1361956|NCT01660893|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1361957|NCT01660893|Secondary|Alcohol Sniff Test|The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.|administered at approximately 24 hours after drug administration||||cm||Standard Deviation|Mean
1361958|NCT01660893|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
1361959|NCT01660893|Secondary|Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
1361960|NCT01660893|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1361961|NCT01660893|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1361962|NCT01660893|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1361963|NCT01660893|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1361964|NCT01660893|Secondary|Number of Participants With Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1361965|NCT01660893|Secondary|Number of Participants With Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
1361966|NCT01660893|Secondary|Intraoral Soft-tissue Anesthesia (Yes/no)|Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe|at 15 minutes with a 3 minute window||||Participants|||Count of Participants
1361967|NCT01660893|Primary|Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).||at 15 minutes with a 3 minute window||||Participants|||Count of Participants
1361968|NCT01660815|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.|0-360 minutes|Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.|||mSv/MBq||Standard Deviation|Mean
1361992|NCT01660672|Other Pre-specified|Mean Time to Return to a BCS Score Greater Than or Equal to 4|Mean time from admission to a BCS score greater than or equal to 4. The BCS (Blantyre Coma Scale) is a 0-5 scale measuring motor response, verbal response and eye movement assessing the severity of coma in children with cerebral malaria. Lower scores correspond to more profound coma.|7 days||||hours||Full Range|Mean
1361972|NCT01660802|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients|||Patients|||Number
1361973|NCT01660763|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. Range of SPID48 scores were -239 to 417.~Time-weighted SPID48 = ∑ [T(i) – T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours"|48 hours||||Units on a scale||Standard Error|Least Squares Mean
1361974|NCT01660737|Secondary|Change of Symptom Tearing Eyes (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361975|NCT01660737|Secondary|Change of Symptom Headache (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361976|NCT01660737|Secondary|Change of Symtom Fatigue / Tiredness|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361977|NCT01660737|Secondary|Change of Symptom Rhinitis (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361978|NCT01660737|Secondary|Change of Symptom Sneezing (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361979|NCT01660737|Secondary|Change of Symptom Bronchial Complaints (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361980|NCT01660737|Secondary|Change of Symptom Burning Eyes (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361981|NCT01660737|Secondary|Change of Symptom Itching Eyes (Pre- Post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361982|NCT01660737|Secondary|Change of Symptom Dry Eyes (Pre- Post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361983|NCT01660737|Secondary|Numerical Rating Scale Well Beeing (Pre- Post)|Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
1361984|NCT01660737|Primary|Tolerability|Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)|app. 4 weeks after baseline (treatment app. for 4 weeks)||||participants|||Number
1361985|NCT01660737|Primary|Efficacy of Pascallerg|Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)|appr. 4 weeks after baseline (after appr. 4 weeks of treatment)||||participants|||Number
1361986|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1, and 2 months||||ng/mL||Standard Deviation|Mean
1361987|NCT01660698|Secondary|Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks|||||||
1361988|NCT01660698|Secondary|Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups||8 weeks|||||||
1361989|NCT01660698|Secondary|Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks|||||||
1361990|NCT01660698|Secondary|Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)|TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.|Measures at baseline, 1, and 2 months||||units on a scale||Standard Deviation|Mean
1361991|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1 and 2 months||||ng/mL||Standard Error|Mean
1361993|NCT01660672|Other Pre-specified|Number of Participants Requiring AED During Admission|Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission.|7 days||||participants|||Number
1362000|NCT01660451|Secondary|Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym) Total Score at Week 16 - Part B|HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. FACT-Lym total score range was 0-168, higher score indicates better HRQoL. Here, in the below table “n” signifies evaluable participants for the respective category.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment. The analysis was performed by using last LOCF method.|||units on a scale||Inter-Quartile Range|Median
1362001|NCT01660451|Secondary|Functional Assessment of Cancer Therapy – Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part B|HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. Score range for the FACT-Lym LymS was 0 - 60, higher score represent less symptoms. Here in below table “n” signifies evaluable participants for the respective category.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment. The analysis was performed by using last observation carried forward (LOCF) method.|||units on a scale||Inter-Quartile Range|Median
1362002|NCT01660451|Secondary|Overall Survival (OS)|OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||days||95% Confidence Interval|Median
1362003|NCT01660451|Secondary|PFS Based on Investigator Assessment|PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||days||95% Confidence Interval|Median
1362004|NCT01660451|Secondary|Progression Free Survival (PFS) Based on Independent Review|PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||days||95% Confidence Interval|Median
1362005|NCT01660451|Secondary|DOR Based on Investigator Assessment|Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as ‘caused by disease progression’ except deaths with the reason “other” or “AE not related to disease progression.|Baseline up to the last patient has completed the 16 weeks of treatment|"PPS (for Part A) included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation.~FAS (for Part B) included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR."|||days||95% Confidence Interval|Median
1362006|NCT01660451|Secondary|Duration of Response (DOR) Based on Independent Review|Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as ‘caused by disease progression’ except deaths with the reason “other” or “AE not related to disease progression.|Baseline up to the last patient has completed the 16 weeks of treatment|"PPS (for Part A) included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation.~FAS (for Part B) included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR."|||days||95% Confidence Interval|Median
1362007|NCT01660451|Primary|ORR Based on Investigator Assessment-Part B|Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||percentage of participants||95% Confidence Interval|Number
1362008|NCT01660451|Primary|ORR Based on Investigator Assessment-Part A|Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.|Baseline up to the last patient has completed the 16 weeks of treatment|Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. Patients who were not evaluable for ORR and discontinued due to a drug-related toxicity, death / progression by clinical judgment before disease was re-evaluated and included.|||percentage of participants||90% Confidence Interval|Number
1362009|NCT01660451|Primary|Objective Response Rate (ORR) Based on Independent Review-Part B|Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||percentage of participants||95% Confidence Interval|Number
1362010|NCT01660451|Primary|Objective Response Rate (ORR) Based on Independent Review-Part A|Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.|Baseline up to the last patient has completed the 16 weeks of treatment|Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. (In Part A, for CLL patients, there was no independent assessment. Instead, the investigator assessment had been used.)|||percentage of participants||90% Confidence Interval|Number
1362011|NCT01660412|Primary|Perceived Pain Level|Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.|immediately after administration (<1 min) of each injection (up to total 5 minutes)||||units on a scale||Standard Deviation|Mean
1362012|NCT01660334|Secondary|Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.|"The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.~Clinical response of cure was assessed comprehensively by physicians in the three categories, which were effective, ineffective, and not evaluable, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests."|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1362013|NCT01660334|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1362014|NCT01660321|Primary|AUC (0-12) for Benzyl Alcohol|Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Since the only benzyl alcohol concentrations above Limit of Quantitation (LOQ) (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC (0-12) was not summarized.|||μg*hr/mL|||Number
1362015|NCT01660321|Primary|Tmax for Benzyl Alcohol|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol|||hours||Full Range|Median
1362016|NCT01660321|Primary|Cmax for Benzyl Alcohol|Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol|||μg/mL||Standard Deviation|Mean
1362017|NCT01660321|Primary|AUC (0-12) for Spinosyn D|Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng* hr/mL|||Number
1362018|NCT01660321|Primary|Tmax for Spinosyn D|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||hours|||Number
1362019|NCT01660321|Primary|Cmax for Spinosyn D|Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng/mL|||Number
1362020|NCT01660321|Primary|AUC (0-12) for Spinosyn A|Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng*hr/mL|||Number
1362051|NCT01660022|Primary|Piperaquine t1/2|Piperaquine Elimination half-life (t1/2).|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||hour||Geometric Coefficient of Variation|Geometric Mean
1362021|NCT01660321|Primary|Tmax for Spinosyn A|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||hours|||Number
1362022|NCT01660321|Primary|Cmax for Spinosyn A|Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng/mL|||Number
1362023|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL||Standard Deviation|Mean
1362024|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL/h||Standard Deviation|Mean
1362025|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h||Standard Deviation|Mean
1362026|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||L/h||Standard Deviation|Mean
1362027|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
1362028|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
1362029|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL||Standard Deviation|Mean
1362030|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL/h||Standard Deviation|Mean
1362031|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h||Standard Deviation|Mean
1362052|NCT01660022|Primary|Piperaquine AUC(0-168)|Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1362032|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||L/h||Standard Deviation|Mean
1362033|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
1362034|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
1362035|NCT01660230|Secondary|Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL||Standard Deviation|Mean
1362036|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL/h||Standard Deviation|Mean
1362037|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h||Standard Deviation|Mean
1362038|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||L/h||Standard Deviation|Mean
1362039|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
1362040|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
1362041|NCT01660230|Secondary|Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||hour (from start of infusion)||Full Range|Median
1362042|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
1362043|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.||Day 6 for multiple-dose cohorts|All 'multiple-dose' subjects who received at least one dose of study treatment.|||participants|||Number
1362044|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.||Day 4 for single-dose cohorts|All 'single-dose' subjects who received at least one dose of study treatment.|||participants|||Number
1362045|NCT01660191|Secondary|Changes HDL Particle Number and LDL Particle Number|Change in levels will be measured by difference in levels at 12 weeks.|Change from Baseline to 12 Weeks||||particle number||Standard Deviation|Mean
1362046|NCT01660191|Secondary|Changes to Glucose Metabolism - Fructosamine|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.|Change from Baseline to 12 weeks||||µmol||Standard Deviation|Mean
1362054|NCT01660022|Primary|OZ439 AUC(0-168)|Area under the plasma concentration versus time curve to 168 hours post-dose.|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1362055|NCT01660022|Primary|Piperaquine Cmax|Piperaquine Maximum concentration level|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1362056|NCT01660022|Primary|OZ439 Cmax|OZ439 Maximum concentration level|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1362057|NCT01659996|Primary|Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|"Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test.~The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3."|Day 30 post-vaccination 2|Antibody responses to Diphtheria, Tetanus, and Polyribosylribitol phosphate antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.|||Percentage of Participants|||Number
1362058|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after the 15 to 18 month vaccination|Solicited reactions were assessed in all subjects who received at least one dose of 15 to 18 month study vaccine, according to the vaccine actually received (Safety Analysis Population).|||Percentage of participants|||Number
1362059|NCT01659996|Primary|Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is <4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ|Day 30 post-vaccination 2|Antibody responses to Pertussis vaccine antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.|||Percentage of Participants|||Number
1362060|NCT01659996|Primary|Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination 2|Geometric Mean Concentrations (GMC) of Pertussis vaccine antibodies were assessed in the Per-protocol population of participants in Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group.|||Titers||95% Confidence Interval|Geometric Mean
1362061|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine.|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after 9-month vaccination|Solicited reactions were assessed in subjects who received at least one dose of study vaccine at 9 month of age, according to the vaccine actually received (Safety Analysis Population).|||Percentage of participants|||Number
1362062|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable.|Day 0 to Day 7 after any vaccination|Solicited reactions were assessed in all subjects who received at least one dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).|||Percentage of participants|||Number
1362160|NCT01658228|Secondary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)|The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Subjects' scores represent the total number of errors made throughout the various tasks. The total number of possible errors is between 0-85.|Week 16||||number of errors on a scale from 0-85||Standard Deviation|Mean
1362063|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test.|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual vaccine antibodies were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and the Pentacel Vaccine Group participants.|||Titers||95% Confidence Interval|Geometric Mean
1362064|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual antibodies were assessed in the Per-protocol population in the Menactra Vaccine Group and Menactra + Pentacel Vaccine Group participants.|||Titers||95% Confidence Interval|Geometric Mean
1362065|NCT01659996|Primary|Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination|"Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC).~Menactra vaccine response defined as subjects with an hSBA titer <1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer."|Day 30 post second Menactra vaccination|Antibody titers to the meningococcal serogroups were assessed in the Per-protocol population of the participants in Menactra Vaccine Group and Menactra + Pentacel Vaccine Group.|||Percentage of participants|||Number
1362066|NCT01659853|Secondary|Onset of Action|Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application|30 minutes after baseline treatment application on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.|||percentage of subjects|||Number
1362067|NCT01659853|Primary|Composite Success|Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period|Hour 6 on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.|||percentage of subjects|||Number
1362068|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at 3-month follow-up."|3-month follow-up|3-month follow-up completers|||participants|||Number
1362069|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.|3-month follow-up|3-month follow-up completers|||participants|||Number
1362070|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at post-treatment."|post-treatment, 6 weeks|Post-treatment completers|||participants|||Number
1362071|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.|Post-treatment, 6 weeks|Post-treatment completers|||participants|||Number
1362072|NCT01659736|Primary|Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.|Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up|Intent-to-treat sample (n = 25)|||units on a scale||Standard Deviation|Mean
1362073|NCT01659567|Secondary|OR for Impact of Cumulative Doses of Ribavirin on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
1362074|NCT01659567|Secondary|OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
1362075|NCT01659567|Secondary|OR for Impact of Duration of Treatment After Achieving cEVR on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
1362161|NCT01658228|Primary|Selective Reminding Test (SRT) Delayed Recall|The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) and delayed recall (after a 15-minute delay) was obtained.|Week 16||||Words||Standard Deviation|Mean
1362076|NCT01659567|Secondary|OR for Impact of Duration of Treatment After Achieving RVR on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
1362077|NCT01659567|Secondary|OR for Impact of Overall Duration of Treatment on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
1362078|NCT01659567|Secondary|OR for Impact of Baseline Viral Load Count on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
1362079|NCT01659567|Secondary|OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
1362080|NCT01659567|Secondary|OR for Impact of Baseline Level of Fibrosis (kPa) on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
1362081|NCT01659567|Secondary|OR for Impact of Body Weight on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
1362082|NCT01659567|Secondary|OR for Impact of Gender on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
1362083|NCT01659567|Secondary|Odds Ratio (OR) for Impact of Age on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
1362084|NCT01659567|Primary|PPV of Complete Early Viral Response (cEVR) on SVR|cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1362085|NCT01659567|Primary|Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR|RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1362162|NCT01658228|Primary|Selective Reminding Test (SRT) Total Recall|The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) was obtained.|Week 16||||Words||Standard Deviation|Mean
1362086|NCT01659567|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR)|SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.|At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants|||Number
1362087|NCT01659554|Secondary|Kaplan-Meier Curves for Patient Overall Survival|Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).|Up to 5 years, survival|zero participants analyzed due to early termination of study||||||
1362088|NCT01659554|Secondary|Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)|Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.|Up to 5 years (survival)|zero participants analyzed due to early termination of study||||||
1362089|NCT01659554|Primary|Toxicity Rating Based on NCI Common Toxicity Criteria|Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).|Up to 5 years|zero participants analyzed due to early termination of study||||||
1362090|NCT01659554|Primary|Adverse Event Rate and/or Laboratory Changes|The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.|5 years|zero participants analyzed due to early termination of study||||||
1362091|NCT01659320|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|A published and widely-used scale for rating depression, the Montgomery Asberg Depression Rating Scale total scores range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|8 weeks|Among 13 subjects who completed the study.|||units on a scale||Standard Deviation|Mean
1362092|NCT01659268|Primary|Time to Conclusion of Simulation Scenario (OSCE)|This result present the total time for execution of simulation scenario (OSCE) by the students.|10 minutes||||seconds||Standard Deviation|Mean
1362093|NCT01659268|Secondary|Number of Attempts to Insertion of LMA|Number of attempts for insertion of LMA and obtainment of effective ventilation.|10 minutes (total time of scenario)||||attempts||Standard Deviation|Mean
1362094|NCT01659268|Secondary|Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.|"Time of achievement to first effective ventilation and tidal volume (adequate chest expansion).~Stabilization of mannequin parameters (spO2 e HR)."|10 minutes (600 sec)||||seconds||Standard Deviation|Mean
1362095|NCT01659268|Primary|Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).|"Score obtained in pre and post-test written, time to obtain the first effective ventilation (chest expansion through adequate ventilation on the mannequin), number of attempts to insert the LMA in the simulation scenario (OSCE).~Pre-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.~Post-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.~OSCE: instrument with total of 10 skills - each skill was subdivided in 4-5 activities (0.2-0.25 points each) - poor performance was score < 5.0; satisfactory performance 5.0-7.0; good 7.0-8.5 and excellent above 8.5 points."|Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes|The number of participants result of students that signed up in the workshop.|||units on a scale||Standard Deviation|Mean
1362096|NCT01659125|Primary|Responder Status|Participants who experienced a clinically significant change in Y-BOCS score defined as posttreatment YBOCS score that (a) has decreased by a reliable level (at least 1.96 times the standard deviation of that measure, taking into account the reliability of the measure itself; in this case, a decrease of 5 points or more), and (b) is within the nonclinical range of scores (in this case, a score of 13 or below).|Week 17 (post-treatment) and 6-month follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).|||participants|||Number
1362097|NCT01659125|Primary|Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions. The total score is reported here and ranges from 0 to 40 with higher scores indicating more severe OCD symptoms.|Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).|||units on a scale||Standard Deviation|Mean
1362098|NCT01659021|Secondary|Complete Response Rate|Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).|Up to 37 months|ITT Analysis Set|||percentage of participants|||Number
1362099|NCT01659021|Secondary|Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation||Up to 37 months|Participants in the ITT Analysis Set with chromosome 17p deletion and/or TP53 mutation were analyzed.|||months||95% Confidence Interval|Median
1362100|NCT01659021|Secondary|Overall Survival|Overall survival was defined as the interval from randomization to death from any cause.|Up to 5 years|ITT Analysis Set|||months||95% Confidence Interval|Median
1362101|NCT01659021|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.|Up to 37 months|Participants in the ITT Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1362163|NCT01658072|Primary|Time Until Patient is Ready for Discharge|"readiness for discharge to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty."|Length of Hospital Stay, an expected average of 3 days||||days||Standard Deviation|Mean
1362102|NCT01659021|Secondary|Overall Response Rate|"Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.~Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.~Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors."|Up to 37 months|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1362103|NCT01659021|Primary|Progression-Free Survival|Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.|Up to 37 months|Intent-to-Treat (ITT) Analysis Set: participants who are randomized in the study with treatment group designated according to initial randomization.|||months||95% Confidence Interval|Median
1362104|NCT01658943|Other Pre-specified|Objective Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible and analyzable patients with measurable disease.|||participants|||Number
1362105|NCT01658943|Other Pre-specified|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
1362106|NCT01658943|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
1362107|NCT01658943|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
1362108|NCT01658904|Secondary|Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT||Day 100 post-AHCT|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.||||||
1362109|NCT01658904|Secondary|Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy||Post-AHCT following CFZ therapy|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.||||||
1362110|NCT01658904|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months and 15 days|Analysis of dose limiting toxicities (DLTs) was planned but not performed due to study termination; this Outcome Measure captures any events that occurred.|||participants|||Number
1362111|NCT01658904|Primary|Engraftment Failure Transplant Related Mortality|Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.|up to day 100||||participants|||Number
1362112|NCT01658839|Primary|Half-life (t½)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||hours||Standard Deviation|Mean
1362113|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||ng*hr/mL||Standard Deviation|Mean
1362127|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 12 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 12||||units on a scale||95% Confidence Interval|Mean
1362114|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||ng*hr/mL||Standard Deviation|Mean
1362115|NCT01658839|Primary|Time to Last Measurable Concentration (Tlast)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||hours||Standard Deviation|Mean
1362116|NCT01658839|Primary|Time to Reach Cmax (Tmax)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||hours||Standard Deviation|Mean
1362117|NCT01658839|Primary|Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)|Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||ng/mL||Standard Deviation|Mean
1362118|NCT01658813|Secondary|Median Survival|Median survival was measured from date of entry on study until date of death|up to 2 years|Data was not collected||||||
1362119|NCT01658813|Secondary|Median Duration of Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up tp 2 years|Data was not collected||||||
1362120|NCT01658813|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 2 years|Data was not collected||||||
1362121|NCT01658813|Secondary|Number of Responses|Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 2 years.|Data was not collected||||||
1362122|NCT01658813|Primary|Progression Free Survival|Progression Free Survival (PFS) was calculated as the time (months) from date of the start of treatment to the date of first observed disease progression (per standard Response Evaluation Criteria In Solid Tumors [RECIST] or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Assessed up to 2 years|Data was not collected||||||
1362123|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 12 Weeks|"Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 12||||units on a scale||95% Confidence Interval|Mean
1362124|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 8 Weeks|"Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 8||||units on a scale||95% Confidence Interval|Mean
1362125|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 4 Weeks|"Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 4||||units on a scale||95% Confidence Interval|Mean
1362126|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 1 Week|"Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10). Higher scores represent higher reported pain."|Week 1||||units on a scale||95% Confidence Interval|Mean
1362128|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 8 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 8||||units on a scale||95% Confidence Interval|Mean
1362129|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 4 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 4||||units on a scale||95% Confidence Interval|Mean
1362130|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 1 Week|"Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0–5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|1 week||||units on a scale||95% Confidence Interval|Mean
1362131|NCT01658657|Primary|Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic|At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.|4 months|6 participants withdrawn before study completion|||participants|||Number
1362132|NCT01658579|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Week 16|Safety population: all randomized participants who were exposed to at least one dose, regardless of amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
1362133|NCT01658579|Secondary|Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Here n = participants with basal insulin dose assessment at specified time-point. Missing data imputed using LOCF.|||U/kg||Standard Deviation|Mean
1362134|NCT01658579|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16|Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.|Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 7-point SMPG assessment, n = participants with 7-point SMPG assessment at specified time. Missing data imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1362135|NCT01658579|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 FPG assessment, n = participants with FPG assessment at specified time. Missing data imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1362136|NCT01658579|Secondary|Change in HbA1c From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population: randomized participants who received at least 1 dose; had baseline, at least 1 post-baseline efficacy assessment; irrespective of compliance. Number of participants analyzed = participants with baseline, Week 8 and/or 16 HbA1c assessment, n = participants with HbA1c assessment at specified time. LOCF applied.|||percentage of hemoglobin||Standard Deviation|Mean
1362137|NCT01658579|Secondary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80–140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Weeks 7-8 in Period A and Weeks 15-16 in Period B|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment, and n = participants with assessment at specified time-point.|||percentage of time||Standard Deviation|Mean
1362154|NCT01658228|Other Pre-specified|COWAT||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
1362155|NCT01658228|Other Pre-specified|WAIS-III Block Design Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
1362156|NCT01658228|Other Pre-specified|WAIS-III Digit Symbol Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
1362157|NCT01658228|Other Pre-specified|Stroop||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
1373641|NCT01525407|Secondary|Overall Survival|Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.|1 year after transplant||||survival probability||95% Confidence Interval|Number
1362138|NCT01658579|Secondary|Evaluation of Diurnal Glucose Exposure, Variability, and Stability|The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
1362139|NCT01658579|Secondary|Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])|Percentage of time with glucose below the lower limit of glycemic range (<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.|||percentage of time||Standard Error|Least Squares Mean
1362140|NCT01658579|Secondary|Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])|Percentage of time with glucose above the upper limit of glycemic range (>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using last observation carried forward (LOCF).|||percentage of time||Standard Error|Least Squares Mean
1362141|NCT01658579|Primary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|Continuous glucose monitoring (CGM) population: All participants who received at least 1 dose, had evaluable post-baseline CGM data, irrespective of compliance. Number of participants analyzed = participants with baseline, Weeks 7-8 (Period A) and/or Weeks 15-16 (Period B) CGM assessment. Missing data imputed using last observation carried forward.|||percentage of time||Standard Error|Least Squares Mean
1362142|NCT01658514|Primary|Correlation of Placebo-adjusted Change From Pre-dose Value in Lactate Versus Metformin Concentration|To determine the exposure-response relationship of metformin and plasma lactate concentrations|from the time of dosing (0 h) to 24 hours postdose|PD Evaluable Population|||R²|||Number
1362143|NCT01658514|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the time of dosing (0 h) to the time of the last quantifiable metformin concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population|||ng/mL||Standard Error|Least Squares Mean
1362144|NCT01658514|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population|||ng*h/mL||Standard Error|Least Squares Mean
1362145|NCT01658436|Secondary|Stage 1 - Disease Control Rate|Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).|||Percentage of participants||95% Confidence Interval|Number
1362146|NCT01658436|Secondary|Stage 1- Overall Response Rate (ORR)|Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).|||Percentage of participants|||Number
1362147|NCT01658436|Primary|Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review|PFS rate at 16 weeks was defined as a binary variable. Patients were considered as ‘progression free’ after 16 weeks if they had an overall lesion response of complete response (CR) partial response (‘PR) or stable disease (SD)’ and “progressed” if they had an overall lesion response of ‘Progressive disease (PD) at the scan which occurred on day 105 after start of treatment, or later. Patients whose 16 weeks tumor assessment was unknown, missing or outside the window was not considered as ‘progression free’ and was considered a “failure” and counted only in the denominator for the estimation of the 16 week progression free rate.|16 weeks after the first BEZ235 administration.|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).|||Percentage of participants||95% Confidence Interval|Number
1362148|NCT01658228|Other Pre-specified|FC-SRT||Week 0 Screening|||||||
1362149|NCT01658228|Other Pre-specified|WMS-R Logical Memory||Week 0 Screening|||||||
1362150|NCT01658228|Other Pre-specified|MRI Scan|Images will be obtained using a GE Signa 3 Tesla whole body scanner. T1-weighted sagittal fspgr and T2 FLAIR are the pulse sequences used in order to obtain the MRI images.|Within 1 month of Screen Visit (Week 0)|||||||
1362151|NCT01658228|Other Pre-specified|University of Pennsylvania Smell Identification Test (UPSIT)|"The subject will scratch and sniff 40 common odorants embedded in microcapsules on a separate page. The subject will choose the answer from a 4-item multiple choice list. Scores will range from 0-40."|Screen (Week 0)|||||||
1362152|NCT01658228|Other Pre-specified|Apolipoprotein E Genotype|Using a standard protocol, DNA is amplified by the polymerase chase reaction (PCR). The genotypes are determined blind to subject status (patient or control) by the sizes of DNA fragments present.|Week 2|||||||
1362153|NCT01658228|Other Pre-specified|Boston Naming||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
1362164|NCT01658020|Secondary|Change in CAT Scores|"The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit.~CAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life.~CAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point.~The scores of each question item were summed into the total score, which had values between 0 and 40."|10 days|Per protocol population|||scores on a scale||Standard Deviation|Mean
1362165|NCT01658020|Secondary|Change in EXACT-PRO Score|"The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit.~EXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD.~EXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation."|10 days|Per protocol population|||scores on a scale||Standard Deviation|Mean
1362166|NCT01658020|Secondary|Microbiological Response Rate|"Microbiological response rate in the microbiological per protocol(PP) population.~Microbiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days||||Percentage of participants||95% Confidence Interval|Number
1362167|NCT01658020|Secondary|Clinical Cure Rate in the Microbiological Per Protocol(PP) Population|"Clinical response corresponding clinical cure in the microbiological per-protocol population.~Microbiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days||||Percentage of participants||95% Confidence Interval|Number
1362168|NCT01658020|Secondary|Clinical Response in the Clinical Population|Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|36days|Per protocol population|||percentage of participants||95% Confidence Interval|Number
1362169|NCT01658020|Primary|Clinical Response in the Clinical Populations|Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|10days|Per protocol population|||percentage of participants||95% Confidence Interval|Number
1362170|NCT01657903|Other Pre-specified|SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis.|||Percentage SMH||Standard Error|Least Squares Mean
1362171|NCT01657903|Other Pre-specified|RER of Enamel Specimens Post 2 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.|||% RER||Standard Error|Least Squares Mean
1362172|NCT01657903|Primary|Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.|||Percentage SMH||Standard Error|Least Squares Mean
1362173|NCT01657903|Primary|Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.|||Percentage RER||Standard Error|Least Squares Mean
1362250|NCT01657019|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety||52 weeks|The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants|||Number
1362174|NCT01657877|Primary|Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed.|||Percentage SMHR||Standard Error|Mean
1362175|NCT01657877|Secondary|Enamel Fluoride Uptake (EFU)|Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.|Baseline to 21 days|PP population: all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||ppm EFU||Standard Error|Mean
1362176|NCT01657877|Secondary|Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses.|||Percentage SMHR||Standard Error|Mean
1362177|NCT01657799|Secondary|Time to Clinical Brain Metastasis Progression|Time to clinical brain metastases progression was defined as the number of days from randomization to the date of the first experience of clinical brain metastases progression, as assessed by a team of neuro-oncology experts (Event Review Board). All events of clinical brain metastasis progression were included, regardless of whether the event occurred while the participant was still receiving study treatment or had previously discontinued study treatment. If a participant did not have an event of clinical brain metastases progression, their data were censored at the date of the last available clinical disease progression assessment. Time to clinical brain metastasis progression was estimated for each treatment group using Kaplan-Meier methodology.|From randomization up to 24 months|All randomized participants|||days||95% Confidence Interval|Median
1362178|NCT01657799|Secondary|Time to Intracranial Progression (Radiographic)|Time to intracranial progression (radiographic) was defined as the number of days from the date of randomization to the date of the first intracranial progression, as determined by brain scan imaging (magnetic resonance image [MRI]/ computed tomography [CT] scan) by a central imaging vendor. All confirmed events of intracranial progression were included, regardless of whether the event occurred while the participant was still taking study treatment or had previously discontinued study treatment. If the participant did not have a confirmed event of intracranial progression, their data were censored at the date of the last available intracranial progression assessment. Time to intracranial progression (radiographic) was estimated for each treatment group using Kaplan-Meier methodology.|From randomization up to 24 months|All randomized participants|||days||95% Confidence Interval|Median
1362179|NCT01657799|Secondary|Best Tumor Response Rate|"Best tumor response rate was calculated as the percentage of participants with a complete response or partial response, as determined by brain scan imaging (magnetic resonance image or computed tomography) by a central imaging vendor. Response was assessed according to the modified bidimensional criteria:~Complete response required all of the following: complete disappearance of all target and non-target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease; no systemic corticosteroid dose.~Partial response required all of the following: ≥ 50% decrease compared with baseline in the size of all target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease and no unequivocal progression of non-target lesions, which, even in presence of stable disease or progressive disease in target lesions, was significant enough to qualify as progression; stable or reduced daily total systemic corticosteroid dose."|From randomization up to 24 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1362180|NCT01657799|Primary|Overall Survival|Overall survival was defined as the number of days from the date of randomization to the date of death. All events of death were included, regardless of whether the event occurred while the participant was still taking study treatment or after treatment was discontinued. If a participant had not died, the data were censored at the date the participant was last known to be alive.|From randomization up to 36 months|All randomized participants|||days||95% Confidence Interval|Median
1362181|NCT01657461|Other Pre-specified|Incidence of sICH at 27±6 Hours Post Randomization||27±6 hours post randomization|One subject in the IV t-PA arm withdrew and requested all data be removed.|||Participants|||Count of Participants
1362182|NCT01657461|Other Pre-specified|Incidence of All Serious Adverse Events (SAEs)||Through 90 days|One subject in the IV t-PA arm withdrew and requested all data be removed.|||Participants|||Count of Participants
1362183|NCT01657461|Secondary|Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage||27±6 hours post randomization|Final assessment not available for all subjects.|||Correlation|||Number
1362184|NCT01657461|Secondary|Arterial Revascularization Measured by TICI 2b or 3 Following Device Use||Post procedure|Final assessment not available for all subjects.|||Participants|||Count of Participants
1362185|NCT01657461|Secondary|Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization||27±6 hours post randomization|Final assessment not available for all subjects.|||Reperfusion ratio||Standard Deviation|Mean
1362186|NCT01657461|Secondary|Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization||27±6 hours post randomization|Final assessment not available for all subjects.|||cc||Standard Deviation|Mean
1362251|NCT01656967|Other Pre-specified|Orolaryngeal Pressure|The oropharyngeal leak pressure (OLP) was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and noting the airway pressure at which equilibrium was reached (not permitted to exceed 40 cm H2O).|Following SGA Insertion||||mmHg||Inter-Quartile Range|Median
1362187|NCT01657461|Secondary|Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization|The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 – 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.|Baseline to 27±6 hours post randomization|Final assessment not available for all subjects.|||units on a scale||Standard Deviation|Mean
1362188|NCT01657461|Secondary|Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days||90 days|Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.|||Participants|||Count of Participants
1362189|NCT01657461|Secondary|Death Due to Any Cause at 90 Days||90 days|One subject in the IV t-PA arm withdrew and requested all data be removed.|||Participants|||Count of Participants
1362190|NCT01657461|Primary|90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).|"mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|90 days|Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.|||Participants|||Count of Participants
1362191|NCT01657370|Other Pre-specified|Plasma MK-1602 Concentrations at Visit 2 (Day 4)||Up to 3.5 hours post dose 3|As per protocol, only listings of individual plasma concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.||||||
1362192|NCT01657370|Other Pre-specified|Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)||3.5 hours post dose 3|As per protocol, only listings of individual DBS concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.||||||
1362193|NCT01657370|Other Pre-specified|Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day||Up to 24 hours post dose 1|As per protocol, only listings of individual DBS for MK-1602 over time were produced. No formal non-compartmental Pharmacokinetic (PK) analysis was done for this outcome measure.||||||
1362194|NCT01657370|Secondary|Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day|TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362195|NCT01657370|Secondary|Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day|TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362196|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362197|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362198|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day||2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362199|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day|Photophobia is sensitivity to light.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362200|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day|Phonophobia is sensitivity to sound.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362201|NCT01657370|Primary|Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day|PR was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362202|NCT01657370|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day|PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
1362203|NCT01657370|Primary|Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day|The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay.|2 hours post dose 1|Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis.|||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
1362204|NCT01657305|Secondary|Adverse Events by Relationship to Study Medication|Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'.|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
1362205|NCT01657305|Secondary|Severity of Adverse Events|Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5).|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
1362206|NCT01657305|Secondary|Frequency of Adverse Events||Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
1362207|NCT01657305|Secondary|Pharmacokinetic (PK) Data (Plasma Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL|up to 4 weeks|A total of 5 participants had a total of 5 samples with betulin concentrations above the LLOQ (1 ng/mL)|||Betulin (ng/mL)|Samples above LLOQ|Full Range|Mean
1362208|NCT01657305|Secondary|Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL.|up to 4 weeks|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Plasma Samples|Plasma Samples||Number
1362209|NCT01657305|Secondary|Likert Scale Rating of Tolerability|Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, standard of care is better tolerated, standard of care is much better tolerated).|up to 4 weeks|The safety analysis population (SAF) included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Percentage of participants|||Number
1362210|NCT01657305|Secondary|Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively|Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation.|3 months and 12 months|The intent-to-treat (ITT) analysis population included 87 participants for the 3-months follow-up and 83 participants for the 12-months follow-up.|||Percentage of wounds||95% Confidence Interval|Number
1362211|NCT01657305|Secondary|Likert Scale Rating of Efficacy|Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective).|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage of efficacy asssessments||95% Confidence Interval|Number
1362212|NCT01657305|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator|A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28.|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=1 participant at all time points.|||Area Percent of initial wound size||95% Confidence Interval|Mean
1362252|NCT01656967|Secondary|Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Approximately 1-2 hours after entering the PACU|||||||
1362213|NCT01657305|Secondary|Percentage of Participants With Wound Closure at Different Time Points|For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated.|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=5 participants at all time points.|||Percentage with wound closure||95% Confidence Interval|Number
1362214|NCT01657305|Secondary|Percentage of Participants With Earlier Healing|Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage with earlier healing||95% Confidence Interval|Number
1362215|NCT01657305|Secondary|Time From Surgery Until Wound Closure is Achieved|Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 107 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 5 of the 107 wounds data were missing, thus the reported values are calculated from 102 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only).|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. For 5 of the 107 wounds, data were missing, thus the reported values are calculated from 102 STSG donor site wound halves by intervention|||Days from surgery until wound closure|Number of STSG wound (halves) analyzed|95% Confidence Interval|Mean
1362216|NCT01657305|Primary|Intra-individual Difference in Time to Wound Closure|Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as [time taken for wound half treated with Oleogel-S10 to close] - [time taken for wound half treated with non-adhesive wound dressing to close], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant.|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10.|||days||95% Confidence Interval|Mean
1362217|NCT01657292|Secondary|Assessment of Adverse Events||2 to 3 weeks|||||||
1362218|NCT01657292|Secondary|Microbial Colonization of the Wound Halves||2 to 3 weeks|||||||
1362219|NCT01657292|Secondary|PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples||2 to 3 weeks|||||||
1362220|NCT01657292|Secondary|Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks|||||||
1362221|NCT01657292|Secondary|Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation||3 and 12 months|||||||
1362222|NCT01657292|Secondary|Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks|||||||
1362223|NCT01657292|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator||2 to 3 weeks|||||||
1362224|NCT01657292|Secondary|Percentage of Patients With Wound Closure at Different Time Points||2 to 3 weeks|||||||
1362225|NCT01657292|Secondary|Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care||2 to 3 weeks|||||||
1362226|NCT01657292|Secondary|Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care||2 to 3 weeks|||||||
1362227|NCT01657292|Primary|Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care|Photo-based evaluation by independent experts blinded to the treatment regime.|2 to 3 weeks|The analysis included all patients who were treated at least once with Oleogel-S10 or Octenilin® wound gel (as randomised) and for whom a difference in wound healing between the treatment was observed.|||percentage of patients||95% Confidence Interval|Number
1362228|NCT01657253|Secondary|Tear Film Break up Time|Change from Baseline in Tear film break up time after 60 days of treatment Tear film breakup time is the elapsed time from blinking to the first occurrence of a dry area in the cornea, visualized with the help of fluorescein staining. Measurement of tear film breakup time will be performed as follows: Fluorescein is instilled in the eye, the patient is asked to blink three times to distribute the dye and then set the eye to the front and do not blink while the examiner observes the cornea with cobalt blue light, looking for an area of tear film rupture, which is manifested by the appearance of a black island within the fluorescein green film. Normally film breakup time is 10 seconds or more and the minimum register may be 1 second, Under 10 seconds is considered abnormal.|Day 60||||seconds|eyes|Standard Deviation|Mean
1362253|NCT01656967|Secondary|Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Within 30 minutes of completion of surgery|||||||
1362229|NCT01657253|Secondary|Schirmer Test|"Change from Baseline in Schirmer test after 60 days of treatment~Schirmer test~It is the technique most used to measure aqueous and at the same time the simplest tear secretion. It is carried out as follows: Without applying anesthesia, the patient is placed somewhere without much illumination, without applying anesthesia, a strip of filter paper of approximately 30 mm is placed, of which, 5 mm must go in the joint Of the middle and outer third of the lower eyelid. The patient is instructed to look forward and to blink normally. After 5 minutes the strips are removed and the wetting is recorded in millimeters. A test less than or equal to 6 mm is diagnostic of aqueous deficiency.The mean of the revisions by group will be compared at the baseline and final visit."|Day 60||||mm/min|eyes|Standard Deviation|Mean
1362230|NCT01657253|Primary|Ocular Surface Disease Index (OSDI©) Questionnaire|Ocular Surface Disease Index (OSDI©) questionnaire , consists of 12 questions divided in 3 groups, Each question has a value that can go from 0 to 4 points according to the severity of the case: 0.None of the time, 1. Some of the time, 2.Half of the time, 3.most of the time and 4 all of the time. The points of all the questions will be used in the following formula for converted to a score of 0-100 : (sum of scores) x 25 / (# of questions answered), where 0 represents normality or non-symptomatology and 100 the most severe case. Will be used to measure the symptoms of dry eye disease by obtaining baseline data and comparing them against the last visit.|Day 60||||points|eyes|Standard Deviation|Mean
1362231|NCT01657032|Secondary|Duration of Intravenous Therapy|need for intravenous rehydration therapy (how long if needed)|7days||||days||Inter-Quartile Range|Median
1362232|NCT01657032|Secondary|Need for Intravenous Therapy|need for intravenous rehydration therapy (yes/no)|yes/no, for 7days||||participants|||Number
1362233|NCT01657032|Secondary|Need for Hospitalization|If the child need to hospitalized|7 days||||participants|||Number
1362234|NCT01657032|Secondary|Tolerance of Products|tolerance of products (whether the child took medicaments),|7days||||participants|||Number
1362235|NCT01657032|Secondary|Diarrhea Recurrence|If the was a diarrhea recurrence during 7days|7 days||||participants|||Number
1362236|NCT01657032|Secondary|Vomiting|How many times the child was vomiting (during the study)|how many times for 7days||||vomiting episodes||Inter-Quartile Range|Median
1362237|NCT01657032|Secondary|Vomiting|If the child vomiting after randomization (yes/no)|yes/no, for 7days||||participants|||Number
1362238|NCT01657032|Secondary|Need for Antibiotic Therapy,|need for antibiotic therapy because of diarrhea|yes/no, for 7days||||participants|||Number
1362239|NCT01657032|Secondary|Consistency of Stools|"consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories.~Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1–2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea."|day 4-th||||Units on a scale||Inter-Quartile Range|Median
1362240|NCT01657032|Secondary|Frequency of Loose Stools,|number of loose stools during 7 days|number of loose stools during 7 days||||number of loose stools during 7days||Inter-Quartile Range|Median
1362241|NCT01657032|Primary|Duration of Diarrhea|The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).|counted in days during 7days||||days||Inter-Quartile Range|Median
1362242|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
1362243|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
1362254|NCT01656967|Secondary|Number of Participants With Overall Intubation Success|Ease of ETT insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At ETT insertion||||participant|||Number
1362255|NCT01656967|Secondary|Number of Participants With Overall Success for SGA Placement|Ease of SGA insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At SGA insertion||||participants|||Number
1362256|NCT01656967|Secondary|Number of Participants in Whom ETT Insertion Was Successful on the First Attempt||At ETT insertion||||participants|||Number
1362257|NCT01656967|Secondary|Number of Participants in Whom SGA Insertion Was Successful on the First Attempt||At SGA insertion||||participants|||Number
1362244|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
1362245|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
1362246|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
1362247|NCT01657019|Secondary|Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)|The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline.|Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||units on a scale||Standard Deviation|Mean
1362248|NCT01657019|Secondary|Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale|The CGI rating scales permitted the global evaluation of a participant’s condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant’s condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a ‘not assessed’ option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation.|Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants||95% Confidence Interval|Number
1362249|NCT01657019|Primary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were “yes,” the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were “no,” then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|53 weeks|The Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||participants|||Number
1362274|NCT01656850|Primary|Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||g/L||Standard Deviation|Mean
1362258|NCT01656967|Secondary|Time for Endotracheal Tube (ETT) Insertion|After the SGA is inserted, time for intubation will be recorded. Time for ETT insertion was measured, for arm 1, from when the AMBU aScope is at the connector level of the Aura-I or, for arm 2, from when the ETT is at the connector level of the Intubating LMA to first detection of CO2 on the capnogram. The AScope 2 disposable fiberoptic camera will be used to assist with intubation for Group 1 patients. Group 2 patients will be intubated using the LMA-Fastrach EndoTracheal Tube.|At ETT insertion||||seconds||Inter-Quartile Range|Median
1362259|NCT01656967|Secondary|Time for Supraglottic Airway (SGA) Insertion|Time for SGA insertion was measured from when the tip of the cuff was at the mouth to detection of CO2 on the capnogram.|At SGA insertion||||seconds||Inter-Quartile Range|Median
1362260|NCT01656967|Primary|Total Intubation Time|Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.|Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion||||seconds||Inter-Quartile Range|Median
1362261|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using a Kaplan-Meier Survival Analysis, with significance being at P < 0.05.|||days to wound closure||Full Range|Median
1362262|NCT01656889|Secondary|Change in Target Ulcer Pain|Target ulcer pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over 12 week treament period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||units on a scale||Standard Error|Least Squares Mean
1362263|NCT01656889|Secondary|Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over the 12 week treatment period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||units on a scale||Standard Error|Least Squares Mean
1362264|NCT01656889|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two and three months following initial ulcer closure.|"The 285 subjects (HP802-247: 141/222; Vehicle: 144/225) who completed the treatment period with confirmed wound closure.~Subjects returning for Visit 1 with confirmed wound closure at end of treatment: 134 HP802-247 and 132 Vehicle.~Subjects returning for Visit 2 with confirmed wound closure at end of treatment: 132 HP802-247 and 131 Vehicle"|||participants|||Number
1362265|NCT01656889|Secondary|Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05|||percentage of Closed Ulcers|||Number
1362266|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05 and by the Kaplan-Meier survival procedure|||days||Full Range|Median
1362267|NCT01656889|Primary|Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05|||participants|||Number
1362268|NCT01656850|Primary|Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||μmol/L||Standard Deviation|Mean
1362269|NCT01656850|Primary|Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||ng/mg creatinine||Standard Deviation|Mean
1362270|NCT01656850|Primary|Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||U/L||Standard Deviation|Mean
1362271|NCT01656850|Primary|Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||nmol/mg||Standard Deviation|Mean
1362272|NCT01656850|Primary|Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||ng/mL||Standard Deviation|Mean
1362273|NCT01656850|Primary|Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||μmol/L||Standard Deviation|Mean
1362279|NCT01656850|Primary|Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mg.min/dL||Standard Deviation|Mean
1362280|NCT01656850|Primary|Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mg/dL||Standard Deviation|Mean
1362281|NCT01656850|Primary|Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mmHg||Standard Deviation|Mean
1362282|NCT01656850|Primary|Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||percentage of body weight||Standard Deviation|Mean
1362283|NCT01656850|Primary|Body Weight at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||kg||Standard Deviation|Mean
1362284|NCT01656850|Primary|Lipid Composition of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months||||g||Standard Deviation|Mean
1362285|NCT01656850|Primary|The Calories of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months||||kcal||Standard Deviation|Mean
1362286|NCT01656850|Primary|Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mg/dL||Standard Deviation|Mean
1362287|NCT01656850|Primary|The Major Nutrients of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months||||% of energy||Standard Deviation|Mean
1362288|NCT01656772|Primary|Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.|The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.|7 days Follow-up||||participants|||Number
1362289|NCT01656772|Primary|The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.|Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.|Peri-procedural|All adverse events reported by the sites were independently adjudicated by the data safety monitory, DSM.|||Pulmonary Veins|Participants||Number
1362290|NCT01656759|Secondary|Postoperative Blood Loss|Measured as drainage output from postoperative drains during hospitalization.|3 days||||mL||Standard Deviation|Mean
1362291|NCT01656759|Secondary|Total Transfusions|The number of transfusions each patient receives during their postoperative hospitalization.|3 days||||Number of transfusions|||Number
1362292|NCT01656759|Primary|Total Blood Loss|Combination of intraoperative and postoperative blood loss for participants.|Collected during surgery and in first 2-3 days after surgery||||mL||Standard Deviation|Mean
1362293|NCT01656759|Primary|Primary--Percent Change of Pre- to Post-Operative Hemoglobin|Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.|Pre-operative to 1 month||||Percent Change||Standard Deviation|Mean
1362294|NCT01656486|Primary|Decreased Secretions|Measurement of pancreatic panel, decreased Pancreatic Secretions|1 year||||participants|||Number
1362295|NCT01656460|Primary|Early and Intermediate Toxicity for Dose Limiting Toxicity|"Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT.~DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT."|3 months||||participants|||Number
1362296|NCT01656434|Secondary|Change From Baseline in Body Weight|Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.|Baseline and Week 52|Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint.|||kilograms||Standard Error|Mean
1362297|NCT01656434|Secondary|Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event||Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.|||Participants|||Number
1362298|NCT01656434|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.|||Percentage of Participants|||Number
1362299|NCT01656434|Secondary|Percentage of Participants With an Absence of Withdrawal Bleeding|Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.||||||
1373642|NCT01525407|Secondary|Non-relapse Mortality|Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.|At 1 year after HCT||||probability||95% Confidence Interval|Number
1362300|NCT01656434|Secondary|Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING."|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.||||||
1362301|NCT01656434|Primary|Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.|Up to 1 year (13 cycles)|Planned analysis for this primary endpoint was not performed due to early study termination.||||||
1362302|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362303|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362304|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mmHg||Standard Error|Least Squares Mean
1362305|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1362306|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362332|NCT01656408|Primary|Cmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
1362307|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362308|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362309|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of pulse pressure||Standard Error|Least Squares Mean
1362310|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362311|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362312|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362333|NCT01656408|Primary|AUC0-24 of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
1362313|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1362314|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362315|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362316|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362317|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1362318|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362345|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 6 and Day 15 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
1362319|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362320|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362321|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1362322|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362323|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362324|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362370|NCT01656304|Secondary|Time to Distant Metastatic Disease|Time to distant metastatic disease using the Kaplan-Meier method|Every 3 months||||months||90% Confidence Interval|Median
1366378|NCT01607645|Secondary|CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years||||Participants|||Count of Participants
1362325|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1362326|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362327|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362328|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362329|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1362330|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
1362331|NCT01656408|Primary|Tmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||hr||Full Range|Median
1362334|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
1362335|NCT01656408|Primary|Tmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
1362336|NCT01656408|Primary|Cmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
1362337|NCT01656408|Primary|AUC0-24 of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
1362338|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
1362339|NCT01656408|Primary|Tmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
1362340|NCT01656408|Primary|Cmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
1362341|NCT01656408|Primary|AUC0-24 of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
1362342|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 15.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
1362343|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
1362344|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
1362396|NCT01656161|Secondary|Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337||Baseline through Day 337|ITT population with a measured value at each specified time point|||percentage of change in PSA levels||Standard Deviation|Mean
1362346|NCT01656408|Primary|t1/2 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the Day 1 dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
1362347|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
1362348|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
1362349|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
1362350|NCT01656408|Primary|Apparent Terminal Half-life (t1/2) of MK-8150 Determined Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
1362351|NCT01656408|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
1362352|NCT01656408|Primary|Maximum Observed Plasma Concentration (Cmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
1362353|NCT01656408|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
1362354|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
1362355|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362467|NCT01654536|Secondary|Percentage of Subjects With Development of or Worsening in Lens Opacities.||0-6 months||||percentage of participants|||Number
1362356|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
1362357|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362358|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
1362359|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362360|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
1362361|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362362|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
1362468|NCT01654536|Secondary|Number of Subjects With Development of or Worsening in Lens Opacities.||0-6 months||||participants|||Number
1362363|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362364|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
1362365|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362366|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
1362367|NCT01656408|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
1362368|NCT01656408|Primary|Number of Participants Discontinued From Study Drug Due to Meeting Hemodynamic Stopping Rules|Hemodynamic criteria for stopping drug dosing were applied (any of the following, obtained resting and if present for ≥1 hour, unless noted). For all Panels: HR >120 bpm; SBP ≥180 mm Hg (Panels A-D/G-J) and ≥175 mm Hg (Panels E-F); DBP ≥110 mm Hg; DBP <50 mm Hg; SBP <90 mm Hg or participant placed in Trendelenburg position. For Panels A-H: HR increase over identified baseline of ≥25 beats per minute; SBP reduction >30 mm Hg versus identified baseline; >20 mm Hg drop in SBP and >20 beats per minute rise in HR observed together versus identified baselines; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. For Panels I-J, any of the following-down dosing criteria if still present 24 hours after dose decrease: HR increase ≥20 beats per minute versus identified baseline; SBP reduction >30 mm Hg versus identified baseline; SBP <100 mm Hg; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together.|Up to 28 days|All participants who received at least one dose of study drug|||participants|||Number
1362369|NCT01656408|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. The 8 crossover Panel H participants are represented in both Panel H – MK-8150 10/20 mg column and Placebo (Panel A - J) column.|Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period)|All participants who received at least one dose of study drug|||participants|||Number
1362371|NCT01656304|Secondary|The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer|PSA velocity with bevacizumab therapy in androgen independent non-metastatic prostate cancer pre-therapy, as well as, PSA velocity with bevacizumab therapy while on therapy.|Baseline, every 6 weeks while on therapy, and then every 3 months thereafter||||ng/ml/month||Full Range|Median
1362372|NCT01656304|Secondary|Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab|Overall survival of androgen independent non-metastatic prostate cancer patients treated with bevacizumab. The number of patients still alive at the end of the study (median K-M estimate cannot be obtained due to the 86.7% censoring rate).|Every 3 months||||Participants|||Count of Participants
1362373|NCT01656304|Primary|Time to PSA Progression (TTPP)|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.|An average every 6 weeks for up to 3 months||||months||90% Confidence Interval|Median
1362374|NCT01656304|Primary|Toxicities Associated With Bevacizumab Therapy|Toxicity rates will be summarized by point estimates and Wilson type 90% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.|An average of every 2 weeks while on therapy||||participants|||Number
1362375|NCT01656304|Primary|PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer|A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.|An average every 6 weeks for up to 3 months||||participants|||Number
1362376|NCT01656252|Other Pre-specified|Exploratory- Eltrombopag Effect on TPO/EPO|To determine if eltrombopag has an effect on TPO and/or EPO in this setting.|62 months|||||||
1362377|NCT01656252|Secondary|Phase II- Safety of Eltrombopag With Consolidation|To determine the safety and tolerability of eltrombopag when given at the optimal dose in the setting of consolidation chemotherapy.|62 months|||||||
1362378|NCT01656252|Secondary|Phase II- Duration of Platelet Nadir|To determine the duration of platelet nadir in the setting of eltrombopag exposure.|62 months|||||||
1362379|NCT01656252|Secondary|Phase II- Depth of Platelet Nadir|To determine the impact of eltrombopag on the depth of platelet nadir following a cycle of consolidation chemotherapy.|62 months|||||||
1362380|NCT01656252|Secondary|Phase II- Time to Platelet Count Recovery|To determine the impact of eltrombopag on time to platelet recovery following consolidation chemotherapy.|62 months|||||||
1362381|NCT01656252|Secondary|Phase II- Bleeding Event Occurrence|To determine the impact of eltrombopag on occurrence of bleeding events.|62 months|||||||
1362382|NCT01656252|Secondary|Phase II- Red Blood Cell Transfusion Requirements|To determine the impact of eltrombopag on red blood cell transfusion requirements.|62 months|||||||
1362383|NCT01656252|Secondary|Phase II- Platelet Transfusion Requirements|To determine the impact of eltrombopag on platelet transfusion requirements in the setting of consolidation chemotherapy.|62 months|||||||
1362384|NCT01656252|Secondary|Phase I & Phase II- Pharmacokinetics of Eltrombopag|To determine the plasma concentrations of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy (selected dosing regimen only).|62 months|Data was not collected.||||||
1362385|NCT01656252|Primary|Phase II- Assess if Platelet Count Recovery is Increased With Eltrombopag|To determine if platelet recovery following consolidation chemotherapy is accelerated with eltrombopag.|62 months|||||||
1362386|NCT01656252|Primary|Phase I - Dose Level With Best Kinetics of Platelet Count Recovery|To describe the kinetics of platelet count recovery in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy who will be receiving eltrombopag. This is assessed graphically by plotting platelet count vs. days relative to start of cytarabine for each patient.|13 months||||mg|||Number
1362387|NCT01656252|Primary|Phase I- Optimal Tolerated Dose of Eltrombopag|To determine the safety, tolerability and optimal dose of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy. The optimal dose was based on rules involving observation of Dose Limiting Toxicity (DLT events), defined as a CTCAE Version 4 non-hematologic adverse event of grade 3 or higher occurring within 30 days of the last dose of eltrombopag judged by the investigator to be at least possibly related to eltrombopag administration.|13 months||||mg|||Number
1362388|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Concentration 0 Hour||Days 1-169 and Days 169-337|Participants in the PK/PD subset with a measured value.|||ng/mL||95% Confidence Interval|Geometric Mean
1362389|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Cmax||Days 1-169 and Days 169-337||||ng/mL||95% Confidence Interval|Geometric Mean
1362390|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)||Days 1-169 and Days 169-337||||days * ng/mL||95% Confidence Interval|Geometric Mean
1362391|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Castration (Tcast)||Days 1-169||||days||95% Confidence Interval|Geometric Mean
1362392|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)||Days 1-169|PK/PD subset of 15 participants|||hours||95% Confidence Interval|Median
1362393|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)||Days 1-169||||nmol/L||95% Confidence Interval|Geometric Mean
1362394|NCT01656161|Secondary|Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)||Days 1-169||||day*nmol/L||95% Confidence Interval|Geometric Mean
1362395|NCT01656161|Secondary|Number of Participants Who Presented a Real “Acute-on-chronic” (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)||Day 171||||participants|||Number
1362397|NCT01656161|Secondary|Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169||on Days 1 and 169|Intention to treat (ITT) population with a measured value at the time analysed|||percentage of participants||95% Confidence Interval|Number
1362398|NCT01656161|Primary|Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)||within 337 days|Intention to treat population|||Percentage of Participants||95% Confidence Interval|Number
1362399|NCT01656031|Primary|Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML|Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.|5 weeks||||participants|||Number
1362400|NCT01655719|Other Pre-specified|Lipid Accumulation in Tumor|Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.|24 weeks|||||||
1362401|NCT01655719|Other Pre-specified|Sensitization to Radioiodine Therapy|Determine if pioglitazone induces a clinically significant level of radioiodine uptake in the residual thyroid carcinoma, and if so, whether there is a therapeutic response to radioiodine. This will be addressed in a separate follow-up protocol available to subjects completing this study.|24 weeks|||||||
1362402|NCT01655719|Other Pre-specified|Biomarkers|Define predictive markers of response or insensitivity to pioglitazone. Unstained tumor tissue slides from archival paraffin blocks, fresh biopsy specimens from measurable metastases, and blood samples (serum and peripheral blood cells) will be collected on enrolled patients who consented for the optional correlative studies. These will be used to identify factors that predict efficacy of pioglitazone. Analyses may include measures of expression of specific RNAs and proteins, and DNA sequence analysis.|24 weeks|||||||
1362403|NCT01655719|Secondary|Toxicity|Toxicities experienced by patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone are indicated by presence of Serious Adverse Events (that show relatedness).|24 weeks||||serious adverse events|||Number
1362404|NCT01655719|Secondary|Change in Serum Thyroglobulin|Determine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.|Baseline and 24 weeks||||ng/mL|||Number
1362405|NCT01655719|Primary|Tumor Response (Change)|Response is measured by change in Tumor size (cm)|Baseline and 24 weeks||||cm|||Number
1362406|NCT01655498|Secondary|Device-related Adverse Events|The number of overall adverse events rated as probably or definitely related to the study device.|1month|All subjects who were exposed to the VBC device (now called Eclipse) during the Treatment Period.|||events|||Number
1362407|NCT01655498|Secondary|Number of Incontinent Days|Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period|1 Month||||days||Standard Deviation|Mean
1362408|NCT01655498|Primary|Frequency of FI Episodes|Subjects with at least a 50% reduction in FI episodes (major or minor soiling)|1 Month|Subjects who were successfully fit with the VBC device.|||percentage of participants|||Number
1362409|NCT01655381|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI|"Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22.~HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||percentage of participants|||Number
1362410|NCT01655381|Secondary|Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission|"HAQ-DI remission was defined as HAQ-DI score <0.5.~HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||percentage of participants|||Number
1362411|NCT01655381|Secondary|Physicians’ Global Assessment of Disease Activity (VAS) Score|The physicians’ global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Full Range|Median
1362412|NCT01655381|Secondary|Participants’ Global Assessment of Disease Activity (VAS) Score|The participants’ global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Full Range|Median
1362413|NCT01655381|Secondary|Participants’ Global Assessment of Pain (VAS) Score|The participants’ global assessment of pain (VAS) was assessed using a 100-mm horizontal VAS with 0=no pain to 100=maximum pain.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Full Range|Median
1362414|NCT01655381|Secondary|C-reactive Protein (CRP) Level|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5 milligrams per liter (mg/L). Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||mg/L||Full Range|Median
1362415|NCT01655381|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||mm/hour||Full Range|Median
1362416|NCT01655381|Secondary|Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time|The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 swollen joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||swollen joints||Standard Deviation|Mean
1362417|NCT01655381|Secondary|Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time|The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 tender joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||tender joints||Standard Deviation|Mean
1362418|NCT01655381|Secondary|Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time|SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), and the patient’s global assessment of disease activity and physician’s global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Standard Deviation|Mean
1362419|NCT01655381|Secondary|Change From Day 1 in DAS28-ESR Scores Over Time|DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient’s global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Standard Deviation|Mean
1362420|NCT01655381|Secondary|Time to RA Flare Following Remission or Drug-Free Remission|Time to RA flare was defined as period of clinical remission or drug-free remission followed by flare of DAS28-ESR (increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2). In the case of several remission periods for the same participant, the largest period was used.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||days||Full Range|Median
1362421|NCT01655381|Secondary|Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare|An RA flare was defined as an increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||percentage of participants|||Number
1362422|NCT01655381|Secondary|Cumulative Time of Remission Per Participant Over the Extension Study Period|Clinical remission was defined as DAS28-ESR <2.6 and/or SDAI ≤3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||days||Full Range|Median
1362423|NCT01655381|Secondary|Percentage of Participants With at Least One Drug-Free Period|Drug-free remission period was defined as clinical remission for at least 2 consecutive assessment visits (every 12 weeks) AND without tocilizumab administration during this clinical remission period.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||percentage of participants|||Number
1362424|NCT01655381|Secondary|Percentage of Participants With at Least One Clinical Remission Period|Clinical remission: Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) less than (<)2.6 and/or Simplified Disease Activity Index (SDAI) less than or equal to (≤)3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient’s global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0-10, with higher scores corresponding to greater disease activity. SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), the patient’s global assessment of disease activity and physician’s global assessment of disease activity; SDAI scores range from 0-86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||percentage of participants|||Number
1362425|NCT01655381|Primary|Percentage of Participants With Any Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator’s judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant.|Up to 160 weeks|Safety population is defined as all included participants who received having at least one tocilizumab administration.|||percentage of participants|||Number
1362426|NCT01655329|Other Pre-specified|Likert-Like|Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image.|10 minutes|All 10 radiologist participants participated|||units on a scale||Standard Deviation|Mean
1362427|NCT01655329|Primary|Accuracy in Detecting the Tips of Tubes, Lines, and Wires.|Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology.|8 hours||||centimeters||Standard Error|Mean
1362428|NCT01655329|Primary|Time for Completion of Tasks|Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time.|8 hours|Each radiologist interpreted only half (158) chest radiographs. All of the radiographs were interpreted by a combination of the 10 radiologist participants.|||seconds|Participants|Standard Error|Mean
1362429|NCT01655069|Secondary|Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume|PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.|Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)|Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.|||mL||Standard Deviation|Mean
1362430|NCT01655069|Secondary|Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents|Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis|||urgency episodes||Standard Error|Mean
1362431|NCT01655069|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.|||micturitions||Standard Error|Mean
1362432|NCT01655069|Secondary|Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days|The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.|||days||Standard Error|Mean
1362469|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
1362433|NCT01655069|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.|||incontinence episodes||Standard Error|Mean
1362434|NCT01655069|Primary|Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)|"The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows:~Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077."|From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).|Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.|||Participants|||Count of Participants
1362435|NCT01655043|Secondary|Coronary Blood Volume Calculation Using MRI Stress Perfusion|The investigators anticipate that CBV changes (in ml/100g of tissue) under stress reflect complementary physiologic feed back to stress perfusion scans, contrary to the hypothesis by many groups who claim that cardiac BOLD and/or rest-perfusion scans can determine without recourse to exercise or pharmacological stress.|18 months|||||||
1362436|NCT01655043|Primary|Quantification of Myocardial Blood Volume|The investigators anticipated that a novel MRI imaging protocol using a high relaxivity blood-pool contrast agent (gadofosveset trisodium) would be capable of quantifying coronary flow reserve based on quantification of myocardial blood volume and would be correlated with myocardial flow reserve as measured in low spatial resolution nuclear SPECT scans. Pre- and post- gadofosveset trisodium images were to be used to calculate the myocardial blood volume. Myocardial blood volume is derived from an equation of the relaxation times of hydrogen atoms in the blood and myocardium. If the agent administered did not behave as a true intravascular agent in the myocardium, quantification of myocardial intravascular blood volume (and hence a calculated coronary flow reserve) could not be calculated using the specified approach. In this case, relaxation times would be reported. Relaxation (R) times are measured in inverse seconds.|outcome measured following single MRI scan||||seconds^-1||Standard Deviation|Mean
1362437|NCT01654887|Primary|Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR||week 1-2||||percentage of participants||95% Confidence Interval|Number
1362438|NCT01654887|Secondary|Comparison of the Length of Stay in the ED|Chart review conducted to assess overall LOS in the ED.|up to 5 hours||||minutes||Inter-Quartile Range|Median
1362439|NCT01654887|Secondary|Percentage of Participants Who Had Hospital Admission.|Chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.|weeks 1-2||||percentage of participants||95% Confidence Interval|Number
1362440|NCT01654887|Secondary|Percentage of Participants With Antibiotic Use|A chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was started on antibiotics during the index Emergency Department (ED) visit or at a later healthcare visit.|weeks 1-2||||percentage of participants||95% Confidence Interval|Number
1362441|NCT01654887|Secondary|Comparison of Unscheduled Healthcare Visits|Percentage of participants who had unscheduled healthcare visits after the index Emergency Department visit between those subjects who undergo CXR first and those who undergo LUS first.|week 1-2||||percentage of participants||95% Confidence Interval|Number
1362442|NCT01654887|Primary|Percentage of Participants For Whom CXR Was Not Needed to Diagnose Pneumonia|The percentage of Participants For Whom CXR Was Not Needed (or received only lung US) to Diagnose Pneumonia. The primary objective of this study is to determine if it is possible for lung ultrasound (LUS) to replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, an overall reduction of CXR when LUS is used first. Null hypothesis is that LUS cannot replace CXR for the diagnosis of pneumonia. Alternate hypothesis is that LUS can replace CXR for pneumonia.|up to 5 hours||||percentage of participants||95% Confidence Interval|Number
1362443|NCT01654861|Secondary|Anti-Tumor Response|CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).|Every 2 months for up to 6 months.|Data were not analyzed as the study was prematurely closed.||||||
1362444|NCT01654861|Primary|Adverse Events as a Measure of Safety and Tolerability|Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.|Weekly for up to 6 months.||||participants|||Number
1362495|NCT01654276|Primary|BMI||6 months||||kg/m^2||Standard Deviation|Mean
1362940|NCT01648452|Primary|Number of Adverse Events at Six Months Post-Implantation|The primary outcome is the total number of adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
1362445|NCT01654796|Primary|Hamilton Rating Scale for Depression – 6 Items|The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.|Baseline and 48 hours after initiating treatment|Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.|||units on a scale||Standard Deviation|Mean
1362446|NCT01654666|Secondary|Serum S-100B Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||pg/mL||Standard Deviation|Mean
1362447|NCT01654666|Secondary|Serum Neuron Specific Enolase (NSE) Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||ng/L||Standard Deviation|Mean
1362448|NCT01654666|Secondary|Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.|The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.|From baseline to 6 months after treatment.||||participants|||Number
1362449|NCT01654666|Secondary|Serum High-sensitive C-reactive Protein (Hs-CRP).||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||mg/L||Inter-Quartile Range|Median
1362450|NCT01654666|Primary|Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.||Within 48 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||participants|||Number
1362451|NCT01654666|Primary|Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.|Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.|Within six months after carotid artery stenting|The analysis population only included participants who fully completed the study.|||participants|||Number
1362452|NCT01654601|Secondary|Accumulation Rate of Clozapine in Plasma||Up tp 12hours||||ng/ml/hr||Standard Deviation|Mean
1362453|NCT01654601|Secondary|Terminal Half Life of Clozapine in Plasma||Up to 12hours||||hour||Standard Deviation|Mean
1362454|NCT01654601|Secondary|Time to Reach Maximum Concentration of Clozapine in Plasma||Up to 12hours||||hour||Standard Deviation|Mean
1362455|NCT01654601|Primary|Maximum Concentration of Clozapine in Plasma||Up to 12hours||||ng/mL||Standard Deviation|Mean
1362456|NCT01654549|Secondary|Anthropometric Measurements|Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study|8 weeks|||||||
1362457|NCT01654549|Secondary|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)|Secondary outcome measure was change in HOMA-IR from baseline to the end of study|8 weeks|||||||
1362458|NCT01654549|Secondary|Serum Lipid Profile|Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study|8 weeks|||||||
1362459|NCT01654549|Secondary|Fasting Serum Glucose|Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study|8 weeks|||||||
1362460|NCT01654549|Secondary|Serum Aspartate Aminotransferase Level|Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study|8 weeks|||||||
1362461|NCT01654549|Secondary|Serum Alanine Aminotransferase Level|Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study|8 weeks|||||||
1362462|NCT01654549|Primary|Liver Fat Content|"Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment).~The percent of liver fat was calculated as below:~“Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) – 0.454 * log (AST/ALT)”"|8 weeks (6 weeks post-treatment)||||percentage of liver fat content||Standard Deviation|Mean
1362463|NCT01654536|Secondary|Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
1362464|NCT01654536|Secondary|Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
1362465|NCT01654536|Secondary|Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of partcipants|||Number
1362466|NCT01654536|Secondary|Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
1362470|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
1362471|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
1362472|NCT01654536|Primary|The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
1362473|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
1362474|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
1362475|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
1362476|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
1362477|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
1362478|NCT01654536|Primary|The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
1362479|NCT01654523|Primary|Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment|Measures severity of trichotillomania. Total score ranges from 0 (none) to 28 (severe). Mean change is determined by score at baseline minus score after treatment.|Baseline to post treatment; typically over 9 weeks||||Units on a scale||Standard Deviation|Mean
1362480|NCT01654302|Primary|Index Knee Pain Scores on a Numeric Rating Scale (NRS)|Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.|5 minutes after stopped exercise, performed 1 hour after intervention (patch application)|Of the 40 subjects 2 were lost to follow-up, one from each group, making a total of 38 participants included in the analysis. Unfortunately, NRS data at 5 minutes post-exercise is missing for 2 subjects in the Synera treatment group and 1 subject in the Placebo group due to technical errors. The data was captured but we were unable to retrieve it.|||units on a scale||Standard Deviation|Mean
1362481|NCT01654276|Primary|Urine pH||6 months||||pH||Standard Deviation|Mean
1362482|NCT01654276|Primary|Fractional Excretion UA||6 months||||% of serum uric acid excreted in urine||Standard Deviation|Mean
1362483|NCT01654276|Primary|Urine Creatinine||6 months||||mg/dl||Standard Deviation|Mean
1362484|NCT01654276|Primary|Urine Uric Acid||6 months||||mg/dl||Standard Deviation|Mean
1362485|NCT01654276|Primary|Serum Triglycerides||6 months||||mg/dl||Standard Deviation|Mean
1362486|NCT01654276|Primary|Serum HDL-cholesterol||6 months||||mg/dl||Standard Deviation|Mean
1362487|NCT01654276|Primary|Seum Total Cholesterol||6 months||||mg/dl||Standard Deviation|Mean
1362488|NCT01654276|Primary|Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)||6 months||||Homeostatic model assessment for Insulin||Standard Deviation|Mean
1362489|NCT01654276|Primary|Serum Insulin||6 months||||mU/L||Standard Deviation|Mean
1362490|NCT01654276|Primary|Serum Glucose||6 months||||mg/dl||Standard Deviation|Mean
1362491|NCT01654276|Primary|Ambulatory Diastolic Blood Pressure|Diastolic BP by ambulatory blood pressure monitor.|6 months||||mmHg||Standard Deviation|Mean
1362492|NCT01654276|Primary|Ambulatory Systolic Blood Pressure|Systolic BP by ambulatory blood pressure monitor.|6 months||||mmHg||Standard Deviation|Mean
1362493|NCT01654276|Primary|Serum Creatinine||6 months||||mg/dl||Standard Deviation|Mean
1362494|NCT01654276|Primary|Serum Uric Acid||6 months||||mg/dl||Standard Deviation|Mean
1362496|NCT01654263|Secondary|Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.|Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 180 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||Titer||95% Confidence Interval|Geometric Mean
1362497|NCT01654263|Primary|Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.|Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 28 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||Titer||95% Confidence Interval|Geometric Mean
1362498|NCT01654263|Primary|Number of Participants Reporting Vaccine-related Serious Adverse Events.|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 180 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||participants|||Number
1362499|NCT01654263|Primary|Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.|"Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 28 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||participants|||Number
1362500|NCT01654263|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events|Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is >0mm.|Days 0 to Day 7 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||participants|||Number
1362501|NCT01654250|Other Pre-specified|Conners Parent Rating Scale (CPRS) Scores|CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1362502|NCT01654250|Other Pre-specified|Clinical Global Impression-Improvement (CGI-I)|The CGI-I measured the participant’s disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1362503|NCT01654250|Other Pre-specified|Clinical Global Impression of Severity (CGI-S)|CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant’s current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1362504|NCT01654250|Secondary|Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant’s performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 and 13 post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1362505|NCT01654250|Secondary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1362506|NCT01654250|Secondary|Onset and Duration of Clinical Effect|Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to [=<] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
1362507|NCT01654250|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points|The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.|0.75 up to 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Least Squares Mean
1362508|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|Day 0||||titers||95% Confidence Interval|Geometric Mean
1362509|NCT01654224|Secondary|Non-inferiority and Immunoprotection Persistence at 6 Months|Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents|6 months|The above numbers reflect the participants with data available at 6 months. Eleven subjects (five in the high dose and 6 in the standard dose groups) died of non-related causes. Some of the samples were insufficient or unable to be collected.|||Titers||90% Confidence Interval|Geometric Mean
1362510|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|30 days||||titers||95% Confidence Interval|Geometric Mean
1362511|NCT01654107|Primary|7-day Point Prevalence Abstinence|3-months after the Quit Date|3-months||||participants|||Number
1362512|NCT01653964|Primary|Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.||At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)|Of 82 patients recruited to the study (prior to breast biopsy), 34 had a histologically-proven diagnosis of breast cancer.|||cancers detected|||Number
1362513|NCT01653912|Secondary|PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)|PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.|From first dose until disease progression or death (approximately 36 months)|ATS population ((Phase 2-Cohort A)|||Months||95% Confidence Interval|Median
1362514|NCT01653912|Secondary|Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)|PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or clinical symptomatic progression or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.|From first dose until disease progression or death (approximately 36 months)|ATS population (Phase 2-Cohort A)|||Months||95% Confidence Interval|Median
1362515|NCT01653912|Secondary|Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125|RR is defined by the percentage of subjects with investigator-assessed Partial Cancer Antigen (CA) 125 Response (PR) or Complete CA 125 Response (CR) at any time during the study by GCIG CA 125. PR is greater than (>) 50% decrease in CA-125 values from baseline and no clinical or radiological evidence of new lesions. CR is decrease in the CA-125 to within the normal limits and less than (<) 40 IU/mL and no clinical or radiological evidence of disease.|From Month 1 to 6|ATS population (Phase 2)|||Percentage of participants|||Number
1362516|NCT01653912|Secondary|Phase 2 Safety: Number of Subjects Reporting Adverse Events|"Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:~Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 [NCI, 2009] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).~Grade 4 neutropenia lasting ≥5 days~Febrile neutropenia~Grade 3 thrombocytopenia with bleeding~Grade 4 thrombocytopenia~Grade 4 anemia~Treatment delay of >14 days due to unresolved toxicity~Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN"|Up to Day 51|ATS population (Phase 2)|||participants|||Number
1362517|NCT01653912|Secondary|Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity||Up to Day 21 (Phase 2)|ATS population (Phase 2)|||participants|||Number
1362518|NCT01653912|Secondary|ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer|"Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.~Overall Response (OR) = CR + PR."|Up to Week 3|ATS population (Phase 1)|||Percentage of participants|||Number
1362519|NCT01653912|Primary|ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B)|"Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.~Overall Response (OR) = CR + PR."|Every 3 weeks up to 6 months|As described in SAP (dated 14-Jul-2015), data was not analyzed separately for Cohort B (n=2) as there were <10 subjects in this group due to difficulty in enrolling Platinum-refractory ovarian cancer subjects.||||||
1362520|NCT01653912|Primary|Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A)|"Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions.~Overall Response (OR) = CR + PR."|Every 3 weeks up to 6 months|ATS population (Phase 2-Cohort A)|||Percentage of participants|||Number
1362521|NCT01653912|Primary|Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183|MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT.|Up to Week 3|ATS population (Phase 1).|||mg|||Number
1362522|NCT01653912|Primary|Phase 1 Safety: Number of Subjects Reporting Adverse Events|"Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel.~Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:~Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 [NCI, 2009] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).~Grade 4 neutropenia lasting ≥5 days~Febrile neutropenia~Grade 3 thrombocytopenia with bleeding~Grade 4 thrombocytopenia~Grade 4 anemia~Treatment delay of >14 days due to unresolved toxicity~Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN"|Up to Week 3|ATS population (Phase 1)|||participants|||Number
1362523|NCT01653912|Primary|Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity||Up to Week 3|All Treated Subjects (ATS) in Phase 1.|||Participants|||Number
1362524|NCT01653782|Secondary|Cost Effectiveness|Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.|6 months, 12 months|||||||
1362525|NCT01653782|Primary|Number of Days on Sick Leave|Sick leave using self-reported data on number of days on sick leave|12 MONTHS|by a power calculation based on estimates of change in the primary outcome variables from earlier studies|||Days||Standard Deviation|Mean
1362526|NCT01653743|Secondary|Percentage of Participants With Clinical Pregnancy|Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
1362527|NCT01653743|Secondary|Percentage of Participants With Biochemical Pregnancy|Percentage of subjects with biochemical pregnancy was assessed. Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS on the Day 35 to 42 post hCG treatment, but with a positive serum β-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than [>] 10 IU/Liter)|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
1362528|NCT01653743|Secondary|Mid-luteal Endometrial Thickness|Endometrial thickness was measured using TVUS.|Day 5 to 7 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||millimeter||Standard Deviation|Mean
1362541|NCT01653418|Secondary|Time to Neutrophil Engraftment After V-BEAM.|Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC > 0.5x109/L post transplant when it is sustained for more than three consecutive days.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||days||Full Range|Median
1362529|NCT01653743|Secondary|Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 9.4 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
1362530|NCT01653743|Primary|Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The modified intent to treat (Mod ITT) population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
1362531|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 10|Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time.|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in the number of participants analyzed for each end point, as represented by n."|||Units on a scale||Standard Deviation|Mean
1362532|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 5|Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time.|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."|||Units on a scale||Standard Deviation|Mean
1362533|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 10|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:~Today my sore felt completely protected~Today my cold sores interfered with facial movements such as smiling, eating or drinking~Today my cold sores interfered with my interaction with other people~Today the patch disguised my cold sores~Today I was bothered by the appearance of my cold sores~Today my patch was easy to apply~Today the patch covering my cold sores was bothersome~Today the patches stayed in place on my cold sores until I removed them~Today the patches were easy to remove from my lip or skin"|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."|||Units on a scale||Standard Deviation|Mean
1362534|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 5|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:~Today my sore felt completely protected~Today my cold sores interfered with facial movements such as smiling, eating or drinking~Today my cold sores interfered with my interaction with other people~Today the patch disguised my cold sores~Today I was bothered by the appearance of my cold sores~Today my patch was easy to apply~Today the patch covering my cold sores was bothersome~Today the patches stayed in place on my cold sores until I removed them~Today the patches were easy to remove from my lip or skin"|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and had at least one post-baseline efficacy measurement. There were difference in number of participants analyzed for each end point as represented by n."|||Units on a scale||Standard Deviation|Mean
1362535|NCT01653509|Primary|Mean Change From Baseline in Color Intensity of Lesions|The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity).|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Least Squares Mean
1362536|NCT01653509|Primary|Mean Change From Baseline in Temperature|Lesion thermographic parameters for TEV and MEV were analysed.|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.|||Degree celsius||Standard Error|Least Squares Mean
1362537|NCT01653509|Primary|Mean Change From Baseline in Blood Flow|"Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique.~Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days."|Baseline to Day 10|Intent to Treat (ITT) population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.|||Perfusion Units||Standard Error|Least Squares Mean
1362538|NCT01653418|Secondary|Time to Platelet Engraftment After V-BEAM.|Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at > 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||days||Full Range|Median
1362539|NCT01653418|Secondary|Treatment Related Mortality (TRM) of V-BEAM||Day +100||||participants|||Number
1362540|NCT01653418|Secondary|Number of Participants With Overall Survival (OS)|OS is defined as the duration from the time of transplant to death or last follow-up.|Median follow-up of 6 months (range: 6-12 months)||||participants|||Number
1362600|NCT01653158|Primary|Recommended Phase 2 Dose (RP2D)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment.|||mg/kg|||Number
1362542|NCT01653418|Secondary|Toxicity of V-BEAM|"Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.~Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.~This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details."|30 days after end of treatment / Day +100||||participants|||Number
1362543|NCT01653418|Secondary|Very Good Partial Response Rate (VGPR+nCR+sCR+CR)|Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
1362544|NCT01653418|Secondary|Overall Response Rate (ORR)|"ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR)~Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|3 months following Day +100 visit|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
1362545|NCT01653418|Secondary|Number of Participants With Progression-free Survival (PFS)|"PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.~Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|Median follow-up of 6 months (range: 6.0-12.0 months)|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
1362546|NCT01653418|Primary|Complete Response Rate (Complete Response + Stringent Complete Response)|Defined by the International Myeloma Working Group (IMWG) criteria|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
1362547|NCT01653262|Secondary|Generalized Seizure Days Over the Treatment Period for Subjects With Idiopathic Generalized Epilepsy|"Generalized seizure days are standardized to a 28-day duration and changes in generalized seizure days are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).~Generalized seizures (Type II) include the following seizure types:~Absence (IIA1)~Atypical absence (IIA2)~Myoclonic (IIB)~Clonic (IIC)~Tonic (IID)~Tonic-clonic (IIE)~Atonic (IIF)~A specific effect of BRV on the occurrence of generalized seizures was not assessed."|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|This variable was not analyzed and no results are available.||||||
1362548|NCT01653262|Secondary|Partial Onset Seizure (POS) Frequency Over the Treatment Period for Subjects With Focal Epilepsy|"The POS frequency is standardized to a 28-day duration and changes in POS frequency are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures (IA)~Complex partial seizures (IB)~Partial seizures evolving to secondarily generalized seizures (IC)"|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Efficacy Analysis Set (EAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline day of seizure daily record card (subject diary card).|||partial onset seizures||Inter-Quartile Range|Median
1362549|NCT01653262|Secondary|Occurrence of Serious Adverse Events During the Study Period|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.|||events|||Number
1362550|NCT01653262|Secondary|Withdrawal Due to an Adverse Event (AE) During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.|||subjects|||Number
1362551|NCT01653262|Secondary|Incidence of Treatment Emergent Adverse Events During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment emergent AE is any event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.|||events|||Number
1362552|NCT01653262|Secondary|Number of Subjects Who Are Free From Nonpsychotic Behavioral Side Effects Over the Entire Treatment Period|Nonpsychotic behavioral side effects (NBSE) include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Visit 2 (Week 0) to Visit 6 (Week 12)|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
1362553|NCT01653262|Secondary|Number of Subjects Who Have a Complete Abatement of Nonpsychotic Behavioral Side Effects for the Last Assessment During the Treatment Period, Based on the Investigator's Overall Assessment|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
1362601|NCT01653158|Primary|Maximum Tolerated Dose (MTD)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment, but excluding those who were enrolled in the expansion cohort.|||mg/kg|||Number
1362554|NCT01653262|Secondary|Change From Study Entry in Nonpsychotic Behavioral Side Effects to the End of the Treatment Period/Early Discontinuation Visit, Measured by Means of the Investigator Global Evaluation of Nonpsychotic Behavioral Side Effects (I-GEBSE) Scale|"There are seven levels for the I-GEBSE:~Marked improvement~Moderate improvement~Slight improvement~No change~Slight worsening~Moderate worsening~Marked worsening"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
1362555|NCT01653262|Secondary|Shift in the Maximum Intensity From Baseline to the End of the Treatment Period for Side Effects Primarily Associated With Discontinuation of Levetiracetam (LEV) as Determined by the Investigator|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
1362556|NCT01653262|Primary|Percentage of Subjects Who Achieved a Clinically Meaningful Reduction of Nonpsychotic Behavioral Side Effects Based on the Investigator's Overall Assessment From Study Entry to the End of the Treatment Period|"Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.~The Investigator completed the assessment by answering the following:~“Has there been a clinically meaningful reduction of nonpsychotic behavioral side effects since the start of BRV?”~- Yes/No"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||percentage of subjects|||Number
1362557|NCT01653158|Secondary|Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.|Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.||||||
1362558|NCT01653158|Secondary|Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4|Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.|Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort.|||mg/L||Standard Deviation|Mean
1362559|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.||||||
1362560|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.||||||
1362561|NCT01653158|Secondary|Observed Accumulation Ratio (Rac) of CP-751,871|AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1|30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||Ratio||Standard Deviation|Mean
1362562|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
1362563|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported because it is the same as Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) in Cycle 1 (OM 23), for both represented the planned 21-day dosing interval.||||||
1362564|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.||||||
1362775|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of time to rescue medication in the postoperative period.|24 hours||||Hours||Standard Deviation|Mean
1362565|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 4 (OM 38) was the correct outcome measure to be registered.||||||
1362566|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/kg||Standard Deviation|Mean
1362567|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 1 (OM 36) was the correct outcome measure to be registered.||||||
1362568|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.||||||
1362569|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/kg||Standard Deviation|Mean
1362570|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||hr||Standard Deviation|Mean
1362571|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||hr||Standard Deviation|Mean
1362572|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.||||||
1362573|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||hr||Standard Deviation|Mean
1362574|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
1362575|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
1362602|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||participants|||Number
1362576|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. AUCinf is not scientifically appropriate for repeated dosing (Cycle 4).||||||
1362577|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
1362578|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported since the actual dosing interval (tau) was longer than 3 weeks in some patients and AUC(0-d22) may not accurately represent multiple-dose exposure for these patients. Therefore only AUCtau, which represents exposure for the actual Cycle 4 interval, was reported for Cycle 4 (OM 40).||||||
1362579|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
1362580|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg/L||Standard Deviation|Mean
1362581|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg/L||Standard Deviation|Mean
1362582|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/day/kg||Standard Deviation|Mean
1362583|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/day/kg||Standard Deviation|Mean
1362584|NCT01653158|Secondary|Circulating Tumor Cells (CTCs), CTCs Expressing Insulin-like Growth Factor 1 Receptor (IGF-1R), and Circulating Endothelial Cells (CECs)||Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)|The data of CTCs and CTCs expressing IGF-IR were limited. Analyses of these biomarkers in the aggregate population were not feasible due to insufficient numbers. The data of CECs were not analyzed due to insufficient levels for quantification.||||||
1362585|NCT01653158|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure (OM) was not analyzed due to incomplete progression reporting, which could not permit accurate estimate of time to tumor progression (TTP).||||||
1362586|NCT01653158|Secondary|Number of Participants With Objective Response (OR)|Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure was not reported because data was available in individual participant listing only and not statistically summarized for the analysis.||||||
1362603|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||participants|||Number
1362587|NCT01653158|Secondary|Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871|The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.|30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion|All enrolled participants who started treatment and had evaluable HAHA data|||Participants|||Number
1362588|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||hr||Standard Deviation|Mean
1362589|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||hr||Standard Deviation|Mean
1362590|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL/(mg/m^2)||Standard Deviation|Mean
1362591|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL/(mg/m^2)||Standard Deviation|Mean
1362592|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL||Standard Deviation|Mean
1362593|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL||Standard Deviation|Mean
1362594|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
1362595|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
1362596|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng*hr/mL||Standard Deviation|Mean
1362597|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng*hr/mL||Standard Deviation|Mean
1362598|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng*hr/mL||Standard Deviation|Mean
1362599|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||nanogram*hour/millilitre (ng*hr/mL)||Standard Deviation|Mean
1362604|NCT01653132|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) Scores|"measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.Drooling Frequency and Severity Score. The Drooling Score equals the sum of the Severity and Frequency sub-scores. The range is 2-9, higher numbers represent worse drooling Drooling Severity Scale~= Never drools, dry~= Mild-drooling, only lips wet~= Moderate- drool reaches the lips and chin~= Severe- drool drips off chin & onto clothing~= Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale~1. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling"|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||units on a scale||Standard Deviation|Mean
1362605|NCT01653132|Primary|Objectively Measured Percentage Salivary Weight|Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||percentage change from baseline||Standard Deviation|Mean
1362606|NCT01653132|Primary|Objectively Measured Salivary Weight|Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||gm||Standard Deviation|Mean
1362607|NCT01653028|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|During treatment and up to 5 years|All patients that began study treatment were assessed for this endpoint.|||participants|||Number
1362608|NCT01653028|Secondary|Progression Free Survival (PFS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).|The time between registration to disease progression or death, assessed up to 18 months||||Weeks||95% Confidence Interval|Median
1362609|NCT01653028|Secondary|Overall Survival (OS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).|The time between registration and death, assessed up to 18 months||||Weeks||95% Confidence Interval|Median
1362610|NCT01653028|Primary|The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.|The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.|Up to 18 months||||percentage of patients with response|||Number
1362611|NCT01652885|Secondary|Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29|5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis.|Baseline, Day 8, 15, 22, 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||units on a scale||Standard Deviation|Mean
1362612|NCT01652885|Secondary|Number of Participants Who Achieved Treatment Success Based on Investigator’s Static Global Assessment (ISGA)|ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29.|Baseline up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||Participants|||Count of Participants
1362613|NCT01652885|Primary|Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.|||hour||Standard Deviation|Mean
1362614|NCT01652885|Primary|Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
1362615|NCT01652885|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.|||hour||Full Range|Median
1362616|NCT01652885|Primary|Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|"PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, Number of Participants Analyzed (N) signifies evaluable participants for this outcome measure."|||nanogram per milliliter||Standard Deviation|Mean
1362617|NCT01652885|Primary|Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.|||hour||Standard Deviation|Mean
1362618|NCT01652885|Primary|Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.|||nanogram*hour per milliliter||Standard Deviation|Mean
1362619|NCT01652885|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.|||hour||Full Range|Median
1362620|NCT01652885|Primary|Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|Pharmacokinetic (PK) population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.|||nanogram per milliliter||Standard Deviation|Mean
1362621|NCT01652885|Primary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362622|NCT01652885|Primary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362623|NCT01652885|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death;initial or prolonged inpatient hospitalization; life­ threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pretreatment state.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362624|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 29|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 29 were reported in this outcome measure.|Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362625|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 22|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 22 were reported in this outcome measure.|Day 22|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1399380|NCT01267422|Primary|Results of CD3/CD4/CD8 Test|The mean percentage of CD3+/CD4+/CD8+ test before and after treatment|up to 6 months||||Percentage of total cells||Full Range|Mean
1362626|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 15|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 15 were reported in this outcome measure.|Day 15|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362627|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 9|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 9 were reported in this outcome measure.|Day 9|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362628|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 8|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 8 were reported in this outcome measure.|Day 8|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362629|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 6|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 6 were reported in this outcome measure.|Day 6|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362630|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 4|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 4 were reported in this outcome measure.|Day 4|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362631|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 2|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure.|Day 2|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362632|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Baseline|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure.|Baseline|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
1362633|NCT01652729|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)|The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.|Baseline to Week 16|Meal Test Evaluable Population: The Meal Test Evaluable Population consists of all modified ITT subjects who participated in the meal test, consumed at least 75% of the standardized meal and had no missing 2-hour postprandial glucose measurements at both Visit 3 (Day 1) and Visit 8 (Week 16), and have adequate study drug exposure.|||mg/dL||Standard Error|Least Squares Mean
1362634|NCT01652729|Secondary|Change in Body Weight (kg) From Baseline to Week 28|The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||kg||Standard Error|Least Squares Mean
1362635|NCT01652729|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||mg/dL||Standard Error|Least Squares Mean
1362636|NCT01652729|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||percentage of subjects|||Number
1362657|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.|Month 18|Full analysis set participants who received a third post-baseline injection (i.e. at month 18)|||participants|||Number
1366379|NCT01607645|Secondary|CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL||Assessed for up to 5 years||||Participants|||Count of Participants
1362637|NCT01652729|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1362638|NCT01652716|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16|Change in 2-hour postprandial glucose concentrations from baseline to Week 16.|Baseline to Week 16|Meal Test Evaluable Subjects: Subjects who were randomized and received at least one dose of study drug and who participated in the meal test at Visit 3 and Visit 13, had adequate and reliable data for the postprandial data evaluation, and had adequate study medication exposure.|||mg/dL||Standard Error|Least Squares Mean
1362639|NCT01652716|Secondary|Change in Body Weight (kg) From Baseline to Week 28|Change in body weight (kg) from baseline to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||kg||Standard Error|Least Squares Mean
1362640|NCT01652716|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||mg/dL||Standard Error|Least Squares Mean
1362641|NCT01652716|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||Percentage of subjects|||Number
1362642|NCT01652716|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
1362643|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1362644|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1362645|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in VLDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1362646|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1362647|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Non-HDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1362648|NCT01652703|Secondary|Percentage of Participants With an LDL-C Response at Week 12|An LDL-C response was defined as LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.|Week 12|Full analysis set|||percentage of participants|||Number
1362649|NCT01652703|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
1362650|NCT01652703|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1362651|NCT01652690|Secondary|Number of Participants With Serious ADRs to Denosumab|Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an “other significant medical hazard” that does not meet any of the above criteria.|24 months|Full analysis set|||participants|||Number
1362652|NCT01652690|Secondary|Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab|Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).|24 months|Full analysis set|||participants|||Number
1362653|NCT01652690|Primary|Number of Participants Having Osteoporosis Related Laboratory Examinations|Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.|Pre-baseline (before first denosumab injection) and post-baseline|Full analysis set; n = participants with visits at each time point.|||participants|||Number
1362654|NCT01652690|Primary|Number of Participants Having Radiologic Bone Assessments|Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.|Pre-baseline (before first denosumab injection) and during the study (post-baseline)|Full analysis set|||participants|||Number
1362655|NCT01652690|Primary|Number of Denosumab Post-baseline Injections Received by Each Participant||24 months|Full analysis set|||participants|||Number
1362656|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.|Month 24|Full analysis set participants who received a fourth post-baseline injection (i.e. at month 24)|||participants|||Number
1402507|NCT01243320|Primary|Change In Granulocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
1362658|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.|Month 12|Full analysis set participants who received a second post-baseline injection (i.e. at month 12)|||participants|||Number
1362659|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.|Month 6|Full analysis set participants who received a first post-baseline injection (i.e. at month 6)|||participants|||Number
1362660|NCT01652690|Primary|Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.|Baseline (day 1)|Full analysis set|||participants|||Number
1362661|NCT01652690|Primary|Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care||24 months|Full analysis set participants who discontinued the study prematurely|||participants|||Number
1362662|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab|Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician’s office.|Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set|||participants|||Number
1362663|NCT01652690|Primary|Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection||Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set; n = the number of participants who received the corresponding injection|||participants|||Number
1362664|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician’s Office|Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.|24 months|Full analysis set (all enrolled patients who provided informed consent and received at least one injection)|||participants|||Number
1362665|NCT01652664|Primary|Mean Change From Baseline in IOP at Month 3|IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.|Baseline (Day 0), Month 3|All participants who received study drug and completed at least 1 scheduled on-therapy visit. No imputation was used, therefore the analysis included only observed cases.|||mmHg||Standard Error|Mean
1362666|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 3 Months|This symptom will be assessed.|Time 3 months||||Participants|||Count of Participants
1362667|NCT01652573|Secondary|Number of Participants With Nasal Ulcerations at 3 Months|This symptom will be assessed.|Time 3 months||||Participants|||Count of Participants
1362668|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 2 Months|This symptom will be assessed.|Time 2 months||||Participants|||Count of Participants
1362669|NCT01652573|Secondary|Number of Participants With Nasal Ulceration at 2 Months|This symptom will be assessed.|Time 2 months||||Participants|||Count of Participants
1362670|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 1 Month|This symptom will be assessed.|Time 1 month||||Participants|||Count of Participants
1362671|NCT01652573|Secondary|Number of Participants With Nasal Ulceration at 1 Month|This symptom will be assessed.|Time 1 month||||Participants|||Count of Participants
1362672|NCT01652573|Secondary|Number of Participants With Allergic Reactions at Baseline|This symptom will be assessed at baseline|Time 0||||Participants|||Count of Participants
1362673|NCT01652573|Secondary|Number of Participants With Nasal Ulcerations at Baseline|This symptom will be assessed at baseline|Time 0||||Participants|||Count of Participants
1362674|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 3 Months|This symptom will be assessed.|Time 3 months||||Participants|||Count of Participants
1362675|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 2 Months|This symptom will be assessed.|Time 2 months||||Participants|||Count of Participants
1362676|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 1 Month|This symptom will be assessed.|Time 1 month||||Participants|||Count of Participants
1362677|NCT01652573|Secondary|Area Under the Curve for 1,25(OH)2vitamin D|Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated and results will be compared to baseline values.|Time 3 months||||ng/ml*hr||95% Confidence Interval|Least Squares Mean
1362678|NCT01652573|Secondary|Area Under the Curve for TmP/GFR|TmP/GFR will be measured 0 to 24 hours postdose during a 24 hr admission at 3 months and AUC calculated and compared to baseline.|Time 3 months||||mg/100 ml GF*hr||95% Confidence Interval|Least Squares Mean
1362679|NCT01652573|Secondary|Number of Patients With Nasal Congestion at Baseline|This symptom will be assessed at baseline|Time 0||||Participants|||Count of Participants
1362680|NCT01652573|Secondary|Area Under the Curve for 1,25(OH)2vitamin D|Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated.|Time 0||||ng/ml*hr||95% Confidence Interval|Least Squares Mean
1362681|NCT01652573|Secondary|Area Under the Curve for TmP/GFR|Serum phosphate will be measured 0 to 24 hours postdose during a 24 hr admission, AUC calculated, and fasting Tmp/GFR calculated.|Time 0||||mg/100 ml GF*hr||95% Confidence Interval|Least Squares Mean
1362682|NCT01652573|Primary|Area Under the Curve for FGF23|FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission at 3 months and AUC calculated and compared to baseline.|3 months||||pg/ml*hr||95% Confidence Interval|Least Squares Mean
1362683|NCT01652573|Primary|Area Under the Curve for FGF23|FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission and AUC calculated.|Time 0||||pg/ml*hr||95% Confidence Interval|Least Squares Mean
1362684|NCT01652495|Secondary|Reduction of Pain Severity Expressed as Percentage Change in VAS Score|"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145–148."|180 days after treatment||||percentage of pain reduction||95% Confidence Interval|Mean
1362685|NCT01652495|Secondary|Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis|"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values"|45 days after treatment||||% of patients with HPA suppression|||Number
1362686|NCT01652495|Primary|Functional Improvement Measured According to Percentage Change in Constant Score|"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4."|180 days after treatment||||percentage of improvement Constant score||95% Confidence Interval|Mean
1362687|NCT01652287|Other Pre-specified|Changes in Composition of the Microbial Community|The secondary aim was to evaluate the influence of BB-12®-supplemented yogurt and control yogurt on the fecal microbiota of participants and determine any changes in the composition of the microbial community.|Day 10|||||||
1362688|NCT01652287|Primary|Number of Adverse Events|The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.|Days 0-180||||Number of AE reported|||Number
1362689|NCT01652040|Secondary|Metabolic Profile|Basal Metabolic Rate|16 weeks||||kcal/day||Standard Deviation|Mean
1362690|NCT01652040|Primary|Body Composition|Changes in body composition fat mass|16 weeks||||percentage of fat mass||Standard Deviation|Mean
1362691|NCT01652001|Secondary|Sialometries|"Unstimulated and stimulated salivary flow rates were assessed in all patients. The unstimulated salivary flow rate was obtained by the spit method every 30 seconds for 15 minutes. Saliva was collected in 20 mL plastic containers, which were pre-weighted.~Stimulated whole saliva was obtained by chewing a 1 g piece of paraffin wax for six minutes. Saliva collected during the first minute was discarded, and then collected into the container every 30 seconds."|2 weeks||||mL/min||Standard Deviation|Mean
1362692|NCT01652001|Primary|Dry Mouth Questionnaire (DMQ)|"Dry Mouth Questionnaire (DMQ) was used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo.~Every participant answered an initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray (1% malic acid or placebo). After two weeks of applications, patients had to answer DMQ 1 again as well as an additional questionnaire (DMQ 2) about the efficacy of the sprays. Increased DMQ scores indicate improvement of xerostomia. DMQ 1 was used to assess the initial severity of oral dryness and in particular its impact on oral function: problems when chewing, swallowing, speaking and general impact on daily life.~DMQ 1 used a 0-to-4 rating scale where 0 = very dry and 4 = not dry at all. After two weeks of treatment, DMQ 1 was repeated and it was included DMQ 2.~At the end values of DMQ 1 and DMQ 2 were summed"|2 weeks||||units on a scale||Standard Deviation|Mean
1362693|NCT01651949|Primary|Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
1362694|NCT01651949|Primary|Percentage of Participants With an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
1362695|NCT01651949|Secondary|Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|Four weeks post vaccination 3 (Month 7)|The analysis set includes participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.|||Percentage of Participants||95% Confidence Interval|Number
1362696|NCT01651949|Primary|Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)|Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
1362717|NCT01651780|Secondary|Acute Kidney Injury|The percentage of participants reporting acute kidney injury is presented.|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.|||percentage of participants|||Number
1362718|NCT01651780|Secondary|Transient Ischemic Attack|The percentage of participants reporting transient ischemic attack is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
1362697|NCT01651949|Primary|Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
1362698|NCT01651949|Primary|Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL|Four weeks post vaccination 3 (Month 7)|The analysis set includes heterosexual male and female participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
1362699|NCT01651936|Secondary|Change From Baseline in the HAQ Disability Index at Week 24|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1362700|NCT01651936|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 24|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0=Absent; 1=Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, 0=no pain to 100=extreme pain); b) Patient’s Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor); c) Investigator’s Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from 0=no difficulty to 24=inability to perform tasks; and e) CRP (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1362701|NCT01651936|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 HAQ Disability Index measurement|||Units on a scale||95% Confidence Interval|Least Squares Mean
1362702|NCT01651936|Secondary|Change From Baseline in DAS28-CRP at Week 24|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH, ). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1362703|NCT01651936|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR50 measurement (last observation carried forward)|||Percentage of participants|||Number
1362748|NCT01651000|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat|||participants|||Number
1363128|NCT01646151|Primary|IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.|Week 12|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1362704|NCT01651936|Secondary|Percentage of Participants Achieving an ACR20 Response at Week 24|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1362705|NCT01651936|Secondary|Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR20 measurement (last observation carried forward)|||Percentage of participants|||Number
1362706|NCT01651936|Primary|Change From Baseline in Disease Activity Score (DAS28) as Measured by C-Reactive Protein (CRP) at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (an inflammatory marker, decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 DAS28-CRP measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
1362707|NCT01651806|Primary|Document Incidences of DVT and Other Thromboembolic Events.|"DVT = Deep Venous thrombosis~Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician."|1 year||||Events|||Number
1362708|NCT01651806|Primary|Primary Intra-operative Blood Loss|Record intra-operative blood loss through drain output|Intra-operative, an average of 3 hours||||mL||Standard Deviation|Mean
1362709|NCT01651793|Secondary|Vigor Symptoms (Profile of Mood State)|Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20.|Pre and 90, 120 and 160 minutes post intervention||||units on a scale||Standard Deviation|Mean
1362710|NCT01651793|Primary|Performance on Bakan Task|"Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3~Bakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times."|baseline, post 60, post 90, post 120||||units on a scale||Standard Deviation|Mean
1362711|NCT01651793|Primary|Correct Responses on Serial 7 Subtraction Task|Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120.|Pre and 30, 60 and 120 minutes post intervention||||Correct responses||Standard Deviation|Mean
1362712|NCT01651780|Secondary|Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor|The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented.|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.|||percentage of participants|||Number
1362713|NCT01651780|Secondary|Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge|The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.|Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)|"Participants in the ITT population with an incidence of major bleeding. Participants were categorized as First half of study site's enrolled participants (Bivalirudin, N=173; UFH, N=173) and Second half of study site's enrolled participants (Bivalirudin, N=171; UFH, N=165). Only sites with >20 participants are included in this analysis."|||percentage of participants|||Number
1362714|NCT01651780|Secondary|New Onset Atrial Fibrillation/Flutter|The percentage of participants reporting new onset atrial fibrillation/flutter is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
1362715|NCT01651780|Secondary|Acquired Thrombocytopenia|The percentage of participants reporting acquired thrombocytopenia is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
1362716|NCT01651780|Secondary|Major Vascular Complications|The percentage of participants reporting a major vascular complications as defined by VARC is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
1362719|NCT01651780|Secondary|Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)|"Percentage of participants with major bleeding according to the following scales:~Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding~Thrombolysis in Myocardial Infarction (TIMI)=major bleeding~Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate~Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding"|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.|||percentage of participants|||Number
1362720|NCT01651780|Secondary|Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke|The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
1362721|NCT01651780|Secondary|NACE at 48 Hours or Before Hospital Discharge|NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.|at 48 hours or before hospital discharge, whichever occurred earlier|Participants in the ITT population.|||percentage of participants|||Number
1362722|NCT01651780|Primary|Net Adverse Clinical Events (NACE) at up to 30 Days|The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.|up to 30 days after procedure|Participants in the ITT population.|||percentage of participants|||Number
1362723|NCT01651780|Primary|Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge|"Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:~Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade.~BARC 3c includes intracranial or intraocular bleeds that compromised vision.~BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period.~BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause."|at 48 hours or discharge, whichever occurs first|Participants in the ITT population.|||percentage of participants|||Number
1362724|NCT01651351|Secondary|Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA|Number of participants with seroconversion|105 days|Safety Analysis Set|||participants|||Number
1362725|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion|Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration|72 hours post infusion to 14 days post infusion|Safety Analysis Set|||adverse events|||Number
1362726|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion|Number of AEs that occurred during an infusion and were deemed related to study product administration|Day 1 and Day 15|Safety Analysis Set|||adverse events|||Number
1362727|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment|Within 72 hours of the end of infusion|Safety Analysis Set|||Infusions|||Number
1362728|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment|Within 24 hours of the end of infusion|Safety Analysis Set|||Infusions|||Number
1362729|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion|Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment|Within 1 hour of infusion completion|Safety Analysis Set|||Infusions|||Number
1362730|NCT01651351|Primary|Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)||Day 1 and Day 15|Safety Analysis Set|||Infusions|||Number
1362731|NCT01651260|Secondary|Ease of Use|Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);|Between 1 - 14 days||||% rating with score of 4 and 5|||Number
1362732|NCT01651260|Primary|Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use|Number of participants with damage of ET tube and Number of participants with occlusion of ET tube|14 days||||participants|||Number
1362733|NCT01651208|Secondary|4-Item Morisky Medication Adherence Scale (MMAS-4)|The Morisky 4-Item Medication Adherence Scale (MMAS-4) is a self-reported measure of medication-taking behavior. Available in 33 languages, it addresses barriers to medication-taking. Each question can be answer as Yes or No for a range of 0-4 points.|At 12 month post stent placement||||Score on a Scale||Standard Deviation|Mean
1362734|NCT01651208|Primary|Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)|Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR>=.80 to define the binary outcome of Appropriate Adherence|12 months after receiving coronary stent||||participants|||Number
1362735|NCT01651104|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1362736|NCT01651104|Primary|Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
1362737|NCT01651104|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
1362738|NCT01651104|Primary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area.~The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1362739|NCT01651039|Secondary|Disease Control Rate for Lens Refractory Rate|The number of response rates in Len refractory participants with SD, MR, PR, VGPR, or CR|up to 4 years||||Participants|||Count of Participants
1362740|NCT01651039|Secondary|Disease Control Rate|The number of response rates participants with SD, MR, PR, VGPR, or CR|up to 4 years||||Participants|||Count of Participants
1362741|NCT01651039|Secondary|Clinical Benefit Rate for Len Refractory Patients|The number of response rates in Lens Refractory participants that have achieved MR, PR, VGPR, CR|up to 4 years|Only Len Refractory Patients|||Participants|||Count of Participants
1362742|NCT01651039|Secondary|Clinical Benefit Rate|The number of response rates in participants that have achieved MR, PR, VGPR, CR|up to 4 years||||Participants|||Count of Participants
1362743|NCT01651039|Secondary|Response Rates for Len Refractory Patients|"Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003).~CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 h MR-≥ 25% but < 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 – 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25‐49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions.~SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline"|up to 4 years||||Participants|||Count of Participants
1362744|NCT01651039|Secondary|Response Rates|"Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003).~CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 h MR-≥ 25% but < 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 – 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25‐49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions.~SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline"|up to 4 years||||Participants|||Count of Participants
1362745|NCT01651039|Primary|Overall Response Rate for Len Refractory Patients|The primary endpoint will be the best overall response rate (ORR)|up to 4 years|Only Len Refractory Patients|||Participants|||Count of Participants
1362746|NCT01651039|Primary|The Best Overall Response Rate (ORR)|The primary endpoint will be the best overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 4 years||||Participants|||Count of Participants
1362747|NCT01651000|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol|||participants|||Number
1362749|NCT01651000|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Per protocol|||participants|||Number
1362750|NCT01651000|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Intent to treat|||participants|||Number
1362751|NCT01650844|Primary|Average Number of Days Without Asthma Symptoms (Symptom Free Days)|The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver.|Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.||||Days||Standard Deviation|Mean
1362752|NCT01650831|Primary|Positive/Negative for H.Pylori With Modified BreathID|The amount of subjects that produced positive/negative results for H.pylori with modified BreathID|1 hour|Per protocol subjects tested with modified BreathID|||participants|||Number
1362753|NCT01650831|Primary|Positive/Negative for H.Pylori With Cleared BreathID|The amount of subjects that produced positive/negative results with cleared BreathID device|1 hour|Per protocol positive/negative when testing with marketed BreathID|||participants|||Number
1362754|NCT01650831|Primary|Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori|The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.|25 minutes|Only subjects that had no recent knowledge of existing H.pylori infection and who met all protocol criteria and had no major protocol deviations, were included in the final analysis set (PP-per protocol).|||Percentage of participants||95% Confidence Interval|Number
1362755|NCT01650805|Secondary|Overall Survival|To compare, according to treatment with ponatinib versus imatinib, overall survival|Up to 8 years after the last patient’s first dose|||||||
1362756|NCT01650805|Secondary|Progression-free Survival|To compare, according to treatment with ponatinib versus imatinib, progression-free survival|Up to 8 years after the last patient’s first dose|||||||
1362757|NCT01650805|Secondary|Complete Cytogenetic Response (CCyR) Rate|The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.|12 months after first dose|Patients with 12 month assessment|||participants|||Number
1362758|NCT01650805|Secondary|<10% BCR-ABL^IS Rate|To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib|3 months after first dose|Patients with 3 month assessment|||participants|||Number
1362759|NCT01650805|Secondary|MMR Rate|To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years|5 years after first dose|||||||
1362760|NCT01650805|Primary|Major Molecular Response (MMR) Rate at 12 Months|A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.|12 months after first dose|Patients with 12 month assessment (due to early termination of the study, none of the endpoints could be evaluated as planned).|||participants|||Number
1362761|NCT01650779|Secondary|Percent Change From Baseline in Gastrointestinal (GI) Symptoms (Abdominal Pain, Abdominal Distention, and Bowel Irregularities) at Month 2, 4, and 6|Gastrointestinal symptoms (abdominal pain, abdominal distention, and irregular bowel movements) were to be assessed by a modified version of the Irritable Bowel Syndrome (IBS) Severity Scoring System. The modified IBS Severity Scoring System is a 7-item questionnaire. The severity score calculated by summing the scores of 5 of the 7 questions. Each of the 5 questions were scored on a scale of 0 to 100, leading to a total possible score range of 0 to 500, where higher scores indicate more severe gastrointestinal symptoms. The data for this outcome measure was exploratory and to be collected in individual participant listing only.|Baseline, Month 2, 4, 6|The data for this outcome measure was exploratory and to be collected in individual participant listing only. Analysis of this data was planned only if baseline data was collected on a large number of enrolled participants. This was not the case and therefore interpretation of these results were not possible.||||||
1362762|NCT01650779|Secondary|Percent Change From Baseline in Urine GL-3 at Month 2, 4, and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for urine GL-3 was 0.2 mcg/mL. The absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing GL-3 (mcg/mL) by creatinine (mg/mL) and multiplying by 113.13 (mg/mmol), the molecular weight of creatinine. For levels reported BQL, the absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing 0.1 (mcg/mL) by creatinine (mg/mL) and multiplying by 133.13 (mg/mmol). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with urine GL-3 assessment at the specified time point.|||percent change||Full Range|Median
1362773|NCT01650545|Secondary|Cytokine Analysis From BAL Fluid in Lung|Multiple cytokines were assessed as markers of lung inflammation that may be used in addition to biopsy data, collected per patient as clinically indicated during the follow-up interval. Values are reported as mean change from baseline in each group, per week|baseline to approximately 1 year||||pg/mL||95% Confidence Interval|Mean
1402508|NCT01243320|Primary|Change In Platelet Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||k/uL||95% Confidence Interval|Mean
1362763|NCT01650779|Secondary|Percent Change From Baseline in Plasma Globotriaosylceramide (GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma GL-3 was 2.0 microgram per milliliter (mcg/mL). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma GL-3 assessment at the specified time point.|||percent change||Standard Deviation|Mean
1362764|NCT01650779|Primary|Percent Change From Baseline in Plasma Deacylated Globotriaosylceramide (Lyso-GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as below quantitative limit (BQL), the lower limit of quantitation (LLOQ) value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma lyso-GL-3 was 5.0 nanogram per milliliter (ng/mL). This study is exploratory because little is known about the dose-response of these biomarkers to enzyme replacement therapy (ERT) or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma Lyso-GL-3 assessment at the specified time point.|||percent change||Standard Deviation|Mean
1362765|NCT01650636|Secondary|Changes in Psychosocial Functioning|Changes in psychosocial functioning measured with the Perceived Stress Scale (PSS), Center for Epidemiologic Studies-Depression (CES-D) scale, and the subscales of the Sickness Impact Profile (SIP) for Recreation and Pastimes, and Social Interaction. Greater scores on the PSS indicate greater perceived stress (range: 0-56) and greater scores on the CES-D indicate greater depressive symptoms (range: 0-60). The SIP is divided into 'Social Interaction' and 'Recreation and Pastimes' subscales (ranges: 0-11 and 0-5, respectively), with greater scores indicating greater impact of sickness in the respective domain. Change scores are expressed and calculated as Follow-Up minus Baseline scores.|baseline and 5 and 9 month post-intervention follow-up|Only CFS Patient's data were analyzed. Partner data was not collected for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1362766|NCT01650636|Secondary|Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines|Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 + IL-10]) for neuroimmune function. These values are expressed as ratios. Change values are expressed and calculated as Follow-Up minus Baseline values (using ratio values).|baseline and 5 and 9 months post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Ratio||Standard Deviation|Mean
1362767|NCT01650636|Secondary|Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines|Serum samples were collected to measure the anti-inflammatory cytokines Interleukin (IL)-4, IL-5 and IL-10 for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).|Baseline, 5 months, 9 months|Only CFS Patients were analyzed. Partner data was not collected for this outcome measure.|||pg/mL||Standard Deviation|Mean
1362768|NCT01650636|Secondary|Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines|Serum samples were collected to measure the pro-inflammatory cytokines Interleukin (IL)-1a, IL-6 and Tumor Necrosis Factor (TNF)-a for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).|Baseline, 5 months, 9 months|CFS Patients Only were analyzed. Data for this outcome measure were not collected from partners.|||pg/mL||Standard Deviation|Mean
1362769|NCT01650636|Secondary|Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.|Changes in salivary cortisol diurnal pattern is measured to determine changes in neuroimmune function. Salivary cortisol diurnal pattern is computed as the natural log of the average within-day slope of change over the 2-day collection period. This measurement is made at baseline, 5 month follow-up and 9 month follow-up. Outcomes are expressed as change in Cortisol Diurnal Pattern (natural log of average 2-day slope values) and expressed and calculated as Follow-Up minus Baseline values (using the natural log of average 2-day slope values).|baseline and 5 and 9 month post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Ug/dL||Standard Deviation|Mean
1362770|NCT01650636|Primary|Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms|Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.|baseline and 5 and 9 months post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Units on a scale||Standard Deviation|Mean
1362771|NCT01650636|Primary|Changes in Frequency and Severity of CDC-based CFS Symptoms|Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.|baseline and 5 and 9 month post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Units on a scale||Standard Deviation|Mean
1362772|NCT01650545|Secondary|Overall Survival at 5 Years Follow-up|Number of participants surviving at 5 year follow-up|5 years||||Participants|||Count of Participants
1362774|NCT01650545|Primary|Number Of Participants With Chronic Rejection Who Met Primary Combined End-point|Treatment failure defined as: BOS progression (> 20% decline lung function), re-transplant, or death|approximately 1 year||||Participants|||Count of Participants
1362776|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site."|24 Hours||||units on a scale||Standard Error|Mean
1362777|NCT01650519|Secondary|Incidence of Serious Adverse Events (SAEs).|Measurement of the incidence of serious adverse events.|24 hours||||Number of Events|||Number
1362778|NCT01650519|Secondary|Patient Satisfaction.|"Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome.~Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)."|24 hours||||units on a scale||Standard Deviation|Mean
1362779|NCT01650519|Secondary|Time to Discharge.|Measurement of the time to discharge in the postoperative period.|24 hours||||Hours||Standard Deviation|Mean
1362780|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of rescue medication in the postoperative period.|24 hours||||milligrams||Standard Deviation|Mean
1362781|NCT01650519|Primary|Efficacy of IV Ibuprofen for Post-op Pain.|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|first possible assessment following surgery||||units on a scale||Standard Deviation|Mean
1362782|NCT01650350|Secondary|To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.||3 months|||||||
1362783|NCT01650350|Primary|Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST|Response will be assessed via RECIST 1.1 criteria utilizing interval CT scans and physical exam after every 3 cycles of treatment (i.e. every 12 weeks).|approximately every 3 months CT, every month physical, up to 6 months||||participants|||Number
1362784|NCT01650324|Secondary|Change of Dipeptidyl Peptidase 4 (DPP4) Activities Between 48 Hrs Post Dose and 0 hr Predose|Change of plasma DPP4 activity at 48 hrs post dose from predose (0 hr). The values were computed as areas under the DPP4 activity-time curve using ANCOVA model, in which the unit of the activity is pmol/min.|predose (0 hr) and 48 hrs post dose|All enrolled participants.|||h*pmol/min||Standard Deviation|Geometric Mean
1362785|NCT01650324|Secondary|Profile of Pharmacokinetics - Time of Maximum Plasma Concentration (Tmax)|Plasma samples were used to determine the Time of Maximum Plasma Concentration for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.|||hrs||Full Range|Median
1362786|NCT01650324|Secondary|Profile of Pharmacokinetics - Observed Maximum Plasma Concentration (Cmax)|Plasma samples were used to determine the Cmax for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.|||ng/mL||Standard Deviation|Geometric Mean
1362787|NCT01650324|Secondary|Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity)|Plasma samples were used to determine the AUC from time 0 to infinity for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.|||ng*h/mL||Standard Deviation|Geometric Mean
1362788|NCT01650324|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|There were 4 mild adverse events observed during the course of study.|Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.|All enrolled participants.|||participants|||Number
1362789|NCT01650285|Secondary|Number of Participants Experiencing a Toxicity Associated With Cabazitaxel and Adjuvant Radiation Following Prostatectomy for Patients With Stage 3 Prostate Cancer and for Patients With a PSA Elevation Post–Prostatectomy.|Assess toxicity using CTCAE version 4.0. Number of patients who experienced a toxicity on the study. Not all toxicities are related to study treatment. Of note, there were no serious adverse events on this trial.|During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks.||||Participants|||Count of Participants
1363129|NCT01646151|Secondary|Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops|Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.|Week 12|All patients|||Percentage of Patients|||Number
1362790|NCT01650285|Primary|Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation|The MTD was not determined secondary to the study closing early. That being said the numbers provided below show that 4 patients were treated on study to aide in the investigation of the MTD. Only 1 dose was fully evaluated which was 5mg/m2|2 mos|while 5 participants were enrolled only 4 completed treatment as patients # 5 only received part of day 1 therapy secondary to an AE and therefore is not included in the assessment.|||mg/m2|||Number
1362791|NCT01650246|Primary|Incidence of Treatment-emergent Adverse Events (TEAEs)||Up to approximately 2 years|Safety Population|||TEAEs|||Number
1362792|NCT01650246|Primary|Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL||Month 1|Safety Population|||Subjects|||Number
1362793|NCT01649856|Secondary|Duration of Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|Up to approximately 4.25 years|ITT Population.|||months||Full Range|Median
1362794|NCT01649856|Secondary|Number of Deaths||Up to approximately 4.25 years|ITT Population.|||participants|||Number
1362795|NCT01649856|Secondary|Duration of Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||months||Full Range|Median
1362796|NCT01649856|Secondary|Number of Participants With Progression, Relapse, or Death|Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||participants|||Number
1362797|NCT01649856|Secondary|Duration of Disease-Free Survival (DFS)|DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population (Responder Subpopulation).|||months||Full Range|Median
1362798|NCT01649856|Secondary|Number of Participants With Relapse or Death at the Time of Primary Analysis|Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)|ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles.|||participants|||Number
1362799|NCT01649856|Secondary|Duration of EFS|EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||months||Full Range|Median
1362800|NCT01649856|Secondary|Number of Participants With an Event-Free Survival (EFS) Event|EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||participants|||Number
1362801|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle|"Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.|||percentage of participants|||Number
1362802|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle|"Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.|||percentage of participants|||Number
1362803|NCT01649856|Secondary|Median Duration of Rituximab Administration for Each Treatment Cycle|Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population; n = number of participants in the analysis for the specified timepoint.|||hours||Full Range|Median
1362858|NCT01649271|Primary|Dose Limiting Toxicities During cycle1|"Number of Patients With Dose Limiting Toxicity (DLT) occurring during Cycle 1 based on the investigator assessment.~One patient in the Afa30+Trast8 cohort developed tumour lysis syndrome during the first course of treatment and was therefore not evaluable for the primary endpoint."|First 21-day treatment cycle|Treated set|||Participants|||Count of Participants
1362804|NCT01649856|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.|||units on a scale||Standard Deviation|Mean
1362805|NCT01649856|Secondary|Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores|The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.|||units on a scale||Standard Deviation|Mean
1362806|NCT01649856|Primary|Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)|Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (>) 75 percent (%) but still >1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).|Up to approximately 4.25 years|Intent-to-Treat (ITT) Population: All participants who completed Baseline and at least one on-treatment efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1362807|NCT01649804|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible scores range from 0 to 3, where 0=least difficulty, and 3=extreme difficulty.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||units on a scale||Standard Deviation|Mean
1362808|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain|"A participant's overall assessment of pain on a VAS was assessed with a question concerning the amount of pain due to arthritis. Pain was assessed on a 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm)."|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
1362809|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity|The participant global assessment of disease activity was measured using a 100 mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
1362810|NCT01649804|Secondary|Time to Rheumatoid Arthritis (RA) Flare|RA flare was defined as any worsening of the participant’s disease activity that in the opinion of the Investigator required treatment intensification beyond supportive therapy which included restarting of the study drug treatment. Time to RA flare was defined as the period of drug-free remission until documentation of RA flare. Drug-free remission was defined as clinical remission (based on DAS28-ESR < 2.6 and /or SDAI ≤ 3.3) for two consecutive assessment visits, followed by discontinuation of tocilizumab, at the Investigator's discretion, at the second assessment visit.|End of Study (Week 104 or early withdrawal)|This outcome could not be evaluated as there were no participants who had achieved drug-free remission, per protocol definition.||||||
1362811|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)|Swollen joint count was performed by a skilled assessor, evaluating 66 joints for swelling.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
1362812|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)|Tender joint count was performed by a skilled assessor, evaluating 68 joints for tenderness.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
1362813|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)|The SDAI was defined as the numerical sum of 5 outcome parameters: tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity on a 100 millimeter (mm) Visual analogue scale (VAS) (VAS; 0 = no disease activity and 100 = worst disease activity) and level of C-reactive protein (CRP) (milligram per deciliter [mg/dl], normal < 1 mg/dl). SDAI total score = 0-86 where a higher score reflects worsening disease. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||participants|||Number
1362981|NCT01648140|Secondary|Apparent Clearance (CL/F) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).|Week 4 (24 h post dose)|Intensive PK Summary Population|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1362814|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)|The DAS28 (ESR) score is a measure of the participant's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR) and general health status. The DAS28-ESR scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity, DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||participants|||Number
1362815|NCT01649804|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||percentage of participants|||Number
1362816|NCT01649791|Secondary|Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry|PI left the institute and the data was not collected.|8 days|No participants were analyzed.||||||
1362817|NCT01649791|Secondary|Incidence of Immune Mediated Flare Reaction|Number of participants with Tumour flare.|24 months|All treated and eligible patients.|||participants|||Number
1362818|NCT01649791|Secondary|Overall Response Rate (CR+PR)||24 months|All treated and eligible patients.|||percentage of participants|||Number
1362819|NCT01649791|Primary|Median Progression-free Survival||24 months|All treated and eligible patients.|||months||95% Confidence Interval|Median
1362820|NCT01649765|Secondary|Area Under Curve of Belimumab at Steady State (AUC, ss)|The PK model was fitted to the observed serum concentration-time data. The AUC values reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.|28-days dosing interval at steady state|PK Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1362821|NCT01649765|Secondary|Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss)|The pharmacokinetic (PK) population comprised all participants included in the As- Treated population for whom at least one post belimumab treatment PK sample was obtained and analyzed. The PK model was fitted to the observed serum concentration-time data. The maximum (Cmax) and minimum (Cmin) concentrations reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.|28-days dosing interval at steady state|PK Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1362822|NCT01649765|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.|Up to 60 weeks|Intent-to-Treat Population|||Participants|||Count of Participants
1362823|NCT01649765|Secondary|Percentage of Participants With a Sustained ParentGA Response|Sustained ParentGA response was defined as having >0.7 improvement at Weeks 44, 48, and 52 compared at Baseline. Data for percentage of participants with a sustained ParentGA response was presented. Thirteen participants had a score of <=0.7 at Baseline and therefore, could not be included in the analysis.|Up to 52 weeks|Intent-to-Treat Population|||Percentage of Participants|||Number
1362824|NCT01649765|Secondary|Percentage of Participants With a Sustained SRI Response|Sustained SRI response was defined as having a response on the primary efficacy endpoint at Weeks 44, 48, and 52. Data for percentage of participants with a sustained SRI response was presented. Drop Outs and Treatment Failures were considered Non-Responders. Only those participants with data available at specific time point were analyzed.|Up to 52 weeks|Intent-to-Treat Population|||Percentage of participants|||Number
1362825|NCT01649765|Secondary|Percent Change From Baseline in Proteinuria at Week 52|Percent change from Baseline in proteinuria was calculated. The percent change from baseline to Week 52 in 24 hour proteinuria was analyzed using summary statistics and 95% confidence intervals, without any adjustment for covariates. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent Change||Full Range|Median
1362826|NCT01649765|Secondary|Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52|The PedsQL is a generic quality of life scale validated for the pediatric population which consists of 23 items, encompassing 4 health domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). From the raw scores of the 23 items, a total summary score and individual domain scores can be calculated. The total and domain scores are each transformed on a 0 to 100 score with higher scores indicating higher quality of life. For Physical Functioning Domain scale, score was from 0 to 100 where, 0 indicates lower quality of life and 100 indicates greater quality of life. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Full Range|Median
1362982|NCT01648140|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.|Week 4 (24 h post dose)|Intensive PK Summary Population|||hour*nanogram per milliliter(hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1362827|NCT01649765|Secondary|Percent Change From Baseline in SELENA SLEDAI at Week 52|The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. One participant had missing data at Baseline and therefore, could not be included in the analysis.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Standard Deviation|Mean
1362828|NCT01649765|Secondary|Percent Change From Baseline in PGA at Week 52|The PGA is a 10 centimeter (cm) visual analogue scale (VAS), anchored at 0 (none) and 3 (severe), designed for the physician to indicate the participant's overall disease activity at a particular visit as part of the validated SELENA SLEDAI index. Primary investigator or a subinvestigator scored the PGA for the participant, and same person evaluated the participant each time. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. LOCF was used.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Standard Deviation|Mean
1362829|NCT01649765|Secondary|Percent Change From Baseline in ParentGA at Week 52|ParentGA assesses the participant’s overall well-being at the moment rated on a 21-numbered circle visual analog scale (VAS; 0 - very well, 10 - very poorly). Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. Last Observation Carried Forward (LOCF) was used. Eight participants had a score of zero at Baseline and therefore, could not be included in the analysis.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Full Range|Median
1362830|NCT01649765|Secondary|Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2|Percentage of participants meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement that is Definition 1: At least 50% improvement in any 2 of 5 endpoints below and no more than 1 of the remaining worsening by more than 30% and Definition 2: At least 30% improvement in 3 of 5 endpoints below and no more than 1 of the remaining worsening more than 30%. Endpoints were: 1. Percent change in Parent’s Global Assessment (ParentGA) at Week 52, 2. Percent change in PGA at Week 52, 3. Percent change in SELENA SLEDAI score at Week 52, 4. Percent change in Pediatric Quality of Life Inventory (PedsQL) physical functioning domain at Week 52, 5. Percent change in 24 hour proteinuria at Week 52 (gram/24hour equivalent by spot urine protein to creatinine ratio).|Week 52|Intent-to-Treat Population|||Percentage of participants|||Number
1362831|NCT01649765|Primary|Percentage of Participants With SLE Responder Index (SRI) Response at Week 52|SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=12 vs. >=13). Percentage of participants with SRI response at Week 52 of Part A were reported. Intent-to-Treat Population comprised of all participants who were randomized and treated with at least one dose of study agent in Part A. One participant had missing data at Baseline and therefore, could not be included in the analysis.|Week 52|Intent-to-Treat Population|||Percentage of participants|||Number
1362832|NCT01649609|Secondary|Number of Participants With Incidence of BK Nephropathy|The number of people with incidence of BK Nephropathy in each of the two Arms|Up to 24 months from randomization||||Participants|||Count of Participants
1362833|NCT01649609|Primary|Number of Participants With BK Viral Load <600 Copies/mL|A Viral load of <600 copies/mL for at least 3 months indicates sustained clearance of BK viremia, confirmed by blood test|Up to 12 months from enrollment||||Participants|||Count of Participants
1362834|NCT01649596|Secondary|Patient Satisfaction|Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared.|12 hours|All patients completed the patient anxiety and satisfaction survey.|||change in percent satisfied|||Number
1362835|NCT01649596|Primary|Incidence of Hypothermic Events|The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).|12 hours||||participants|||Number
1362836|NCT01649557|Secondary|Percentage of Participants Who Discontinued Due to Lack of Efficacy.|Discontinuation rate for the participants discontinued due to lack of efficacy were examined.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Percentage of participants.|||Number
1362837|NCT01649557|Secondary|Percentage of Participants With a Positive Response Rate.|Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Percentage of participants|||Number
1362983|NCT01648140|Secondary|Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.|Week 4 (24 h post dose)|Intensive PK Summary Population|||hour||Full Range|Median
1362838|NCT01649557|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
1362839|NCT01649557|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
1362840|NCT01649557|Secondary|Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.|The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
1362841|NCT01649557|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.|The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 1, 2, 6, 26, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Full Range|Median
1362842|NCT01649557|Secondary|Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.|The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?” Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
1362843|NCT01649557|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
1362844|NCT01649557|Primary|Number of Participants With AEs in 52-Week Enrollers.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 52 weeks|Those participants who received at least one dose of open-label brexpiprazole and who were enrolled in the 52-week study.|||Participants|||Number
1362859|NCT01649271|Primary|MTD of Afatinib in Combination With Trastuzumab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).|"Maximum Tolerated Dose (MTD) of Afatinib in combination with trastuzumab based on the number of patients with dose limiting toxicity (DLT) during the first treatment cycle (Dose escalation part). The MTD was defined as the highest dose studied at which the incidence of a DLT was less than 17% (i.e. 1/6 patients) during the first cycle.~One patient in the Afa30+Trast8 cohort developed tumour lysis syndrome during the first course of treatment and was therefore not evaluable for the primary endpoint."|First 21 days treatment cycle|Treated set: This analysis set includes all patients who were documented to have taken at least one dose of study medication.|||mg|||Number
1362845|NCT01649557|Primary|Number of Participants With Adverse Events (AEs) During First 6 Weeks.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 6 weeks|The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole and were enrolled in the 6-week study.|||Participants|||Number
1362846|NCT01649505|Secondary|Serious and Nonserious Adverse Events and Complications||Up to day 180 post-operation|||||||
1362847|NCT01649505|Secondary|Quantity of Post-operative Drainage|Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.|Up to day 10 post-operation|||||||
1362848|NCT01649505|Secondary|Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications|Computed with 95% confidence interval using exact method. Two-sided Fisher’s exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed.|Up to day 180 post-operation|||||||
1362849|NCT01649505|Primary|Proportion of Patients in Each Arm Who Develop Post-operative Seromas|Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher’s exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.|Up to day 180 post-operation|||||||
1362850|NCT01649362|Secondary|Breastfeeding Rate at Discharge||hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction||||participants|||Number
1362851|NCT01649362|Secondary|Length of Hospital Stay||participants were followed for the duration of hospital stay, an expected average of 5 weeks||||days||Standard Deviation|Mean
1362852|NCT01649362|Primary|Length of Transition Period|transition period was defined as the period from the introduction of enteral feeding to full enteral feeding|participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks||||days||Standard Deviation|Mean
1362853|NCT01649297|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 16|"Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.~Means provided are the adjusted means."|Baseline and 16 weeks|FAS with LOCF has been used for FPG analyses|||mg/dL||Standard Error|Mean
1362854|NCT01649297|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16|"Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.~Means provided are the adjusted means."|Baseline and 16 weeks|"Full Analysis Set (FAS) is the basis for the intention-to-treat analysis. FAS with last observation carried forward (LOCF) imputation is used as the primary method of accounting for missing data.~Values after the patient started rescue medication were excluded from analysis (and imputed with an LOCF procedure)."|||percentage of HbA1c||Standard Error|Mean
1362855|NCT01649271|Secondary|Clinical Benefit|"Clinical benefit was defined as best overall response of CR or PR or stable disease (SD) where best overall response is defined according to RECIST version 1.1 from first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy.~As Per RECIST v1.1 for target lesions (TL) & assessed by MRI: CR: Disappearance of all TL,all non-TL, & no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least 30% decrease in sum of the longest diameter (SLD) of TL taking as reference the baseline SLD. SD: Neither sufficient shrinkage to qualify for PR, taking as reference the baseline SLD, nor sufficient increase to qualify for PD."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 33 months|Treated set|||percentage of participants|||Number
1362856|NCT01649271|Secondary|Objective Response|Objective Response (OR) was defined as best overall response of complete response (CR) or partial response (PR), where best overall response was determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 from first administration of study medication until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy. As Per RECIST v1.1 for target lesions (TL) & assessed by MRI: CR: Disappearance of all TL,all non-TL, & no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least 30% decrease in sum of the longest diameter (SLD) of TL taking as reference the baseline SLD.|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 33 months|Treated set|||percentage of participants|||Number
1362857|NCT01649271|Secondary|Best Overall Response (BOR)|BOR represents the best response a patient had during their time in study from start of treatment until progression, the last evaluable assessment in absence of progression or start of subsequent anticancer therapy. For patients that died, BOR was to be calculated based on data up to last evaluable RECIST,v1.1 assessment prior to death. Death did not contribute as PD for BOR. As per RECIST v1.1 for target lesions (TL) & assessed by MRI: CR: Disappearance of all TL,all non-TL, & no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least 30% decrease in sum of the longest diameter (SLD) of TL taking as reference the baseline SLD. PD: At least a 20% increase in SLD of TL taking as reference the smallest SLD recorded since treatment started, together with an absolute increase in SLD of at least 5mm. SD: Neither sufficient shrinkage to qualify for PR, taking as reference the baseline SLD, nor sufficient increase to qualify for PD.|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until End of Treatment (EOT); up to 33 months|"Treated set~Missing: First image time point not reached before discontinuation."|||percentage of participants|||Number
1362860|NCT01649232|Secondary|Number of Omission and Commission Errors of Behavior Task|After VCPT task, errors by Omission (lack of response in test GO) and by commission (lack of suppression in NOGO and NOVELTY test) were automatically counted for each subject.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.|||Number of omission and commision errors||Standard Deviation|Mean
1362861|NCT01649232|Secondary|Reaction Time (Behavior Task)|"All subjects performed a Visual continuous performance task (VCPT) with GO/NOGO paradigm. It consists of three types of stimuli: 1) twenty animals (A), 2) twenty images of different plant (P), 3) Twenty images of people of different professions (H) which is present with an artificial sound called Novel 20msec and.Thus, each pair of stimulus is presented for 100 milliseconds, at intervals of one second of duration between each block. The objective of is to press a button as quickly as possible while observing the pairs AA, situation called GO, while trying not to press when observes other types of pairs. This latency of response (reaction time) was mensured. Pairs are called GO(AA) NOGO(AP), IGNORE(PP) and NOVEL(PH + Sound). Errors by omission (lack of response in test GO) and by commission (lack of suppression in NOGO test) were be automatically counted for each subject."|From September to December 2012||||milliseconds||Standard Deviation|Mean
1362862|NCT01649232|Secondary|Event-related Potentials Latency (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain’s executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012||||milliseconds||Standard Deviation|Mean
1362863|NCT01649232|Secondary|Event-related Potentials Amplitude (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain’s executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.|||microVolts||Standard Deviation|Mean
1362864|NCT01649232|Primary|Clinical Assessment (Amen Questionnaire)|"The Amen Attention Deficit Disorder (ADD) Type Questionnaire is a 71-question self-test that evaluates the ADD syndrome. 0 never, 1 rarely, 2 Occasionally, 3 Often and 4 Very Often. Consists of a series of questions that evaluate five brain systems: basal ganglia (23 items), Cingular System (17 items), Temporal System (16 items), Prefrontal Cortex (24 items) and deep limbic system (20 items). Each system has a maximum score of 4, and if this punctuation is greater than 1.7 it is possible that the system is deviated from normality and implicated in AD/HD behavior.~The minimal average score is 5 (Best) and the maximum is 20 (Worst). More than four is suspicious of diagnosis, six or more of a score of three or four is needed to make diagnosis. Meets the criteria for inattentiveness (six or more on questions 1-14) and also scores six or more on the cingular system questions (24-36 items), over-focused ADD subtype is suspected."|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.|||units on a scale||Standard Deviation|Mean
1362865|NCT01649180|Secondary|Tumor Tissue Banking|"To bank tumor tissue (formalin-fixed, paraffin-embedded tumor blocks) for retrospective examination of the molecular pathophysiologic mediators of tumorigenesis and progression such as phospho-protein expression of MAPK signaling network intermediates in endothelial cells. Banking of tumor tissue is optional but strongly encouraged.~Note: None of the 3 patients submitted tumor tissues so the analysis won't be performed."|Baseline|||||||
1362866|NCT01649180|Secondary|Biospecimen Banking for SNPs Analysis|"To bank biospecimens for the retrospective determination of whether baseline single nucleotide polymorphisms (SNPs) in angiogenesis-related genes predict response to treatment (candidate gene approach). Banking of PBMC is optional but strongly encouraged.~Note: The SNP genotyping analysis was not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the association between baseline SNPs in angiogenesis-related genes and response was not be done."|Baseline|||||||
1362867|NCT01649180|Secondary|Biospecimen Banking for IL-8 and VEGF-A|"To bank biospecimens for the retrospective determination of whether baseline or changes in cytokine levels of IL-8 and VEGF-A predict response to treatment in this setting. Banking of plasma and serum is optional but strongly encouraged.~Note: The assays to assess cytokine levels of IL-8 and VEGF-A were not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the associations between response and IL-8 as well as VEGF-A was not be done."|Baseline and 8 weeks|||||||
1362868|NCT01649180|Secondary|Overall Response Rate|"Best overall response was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0). Response is defined as complete response or partial response.~Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions"|Assessed every 12 weeks up to 36 months|all participants|||proportion of participants||95% Confidence Interval|Number
1373643|NCT01525407|Secondary|Non-relapse Mortality|Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.|At day 100||||probability||95% Confidence Interval|Number
1362869|NCT01649180|Primary|Progression-free Survival|Progression-free survival is defined as the time from registration to disease progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Assessed every 12 weeks up to 36 months|all participants|||months||95% Confidence Interval|Median
1362870|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour||||participants|||Number
1362871|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=25ppb to <=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour||||participants|||Number
1362872|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not smoke previously or are current smokers."|approximately 1-hour||||participants|||Number
1362873|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <=25ppb to <=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour||||participants|||Number
1362874|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour||||participants|||Number
1362875|NCT01648920|Primary|FeNO Values by ICS Use: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour||||participants|||Number
1362876|NCT01648920|Primary|Negative Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Negative predictive value is a way of saying the likelihood of a negative test means you do not have disease. In this study it is defined as the percentage of study participants with a low FeNO who do not have asthma."|approximately 1-hour||||percent|||Number
1362877|NCT01648920|Primary|Positive Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Positive predictive value is a way of saying the likelihood a positive test means you have a disease. In this study, it is defined as the percentage of study participants with a high FeNO who have asthma."|approximately 1-hour||||percent|||Number
1362878|NCT01648920|Primary|Specificity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Specificity is a way of saying how likely a test is negative if you do not have a disease and is expressed as (%) percent. For this study, specificity was the ability of FeNO to correctly identify a study participant who does not have asthma."|approximately 1-hour||||percent|||Number
1362879|NCT01648920|Primary|Sensitivity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Sensitivity is a way of saying how likely a test is positive if you have a disease and is expressed as (%) percent. For this study, sensitivity was the ability of FeNO to correctly identify a study participant who has asthma."|approximately 1-hour||||percent|||Number
1366380|NCT01607645|Secondary|CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years||||Participants|||Count of Participants
1362880|NCT01648920|Primary|Asthma Diagnosis by FeNO: Mean FeNO Value|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||Parts per billion (ppb)||Standard Deviation|Mean
1362881|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
1362882|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
1362883|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
1362884|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Negative MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour||||participants|||Number
1362885|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Positive MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine."|approximately 1-hour||||participants|||Number
1362886|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >50ppb|||participants|||Number
1362887|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >= 25 ppb to <= 50 ppb|||participants|||Number
1362888|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with a FeNO < 25 ppb|||participants|||Number
1362889|NCT01648920|Primary|Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||parts per billion (ppb)||Standard Deviation|Mean
1362890|NCT01648920|Primary|Methacholine Challenge (MCC) Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
1362891|NCT01648790|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1362892|NCT01648790|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1362893|NCT01648790|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1362894|NCT01648790|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1362895|NCT01648699|Secondary|Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician|"The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from very much worse to very much improved (as compared to Baseline)."|Day 28|"ITT population included all participants who received at least one dose of study medication at Baseline. n signifies those participants who were evaluated for this measure at the specified time point. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."|||Participants|||Number
1362896|NCT01648699|Secondary|Number of Participants Given Rescue Pain Medications|Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.|||Participants|||Number
1362897|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Day 28|The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1362898|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Baseline|The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Baseline|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.|||Units on a scale||Standard Deviation|Mean
1362899|NCT01648582|Secondary|Change From Baseline in EQ-5D Visual Analog Scale Score|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
1362900|NCT01648582|Secondary|EQ-5D Health State Score Responses|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||participants|||Number
1362924|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)|The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.|6 months||||units on a scale|||Number
1362901|NCT01648582|Secondary|Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||Percentage of participants|||Number
1362902|NCT01648582|Secondary|Change in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||kilogram/square meter (kg/m2)||Standard Error|Least Squares Mean
1362903|NCT01648582|Secondary|Change From Baseline in Body Weight||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||kilogram (kg)||Standard Error|Least Squares Mean
1362904|NCT01648582|Secondary|Number of Participants With Adjudicated Pancreatitis|The number of participants with pancreatitis confirmed by adjudication is summarized. Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||participants|||Number
1362905|NCT01648582|Secondary|Number of Participants With Adjudicated Cardiovascular (CV) Events|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||participants with adjudicated CV events|||Number
1362906|NCT01648582|Secondary|Change From Baseline in Serum Calcitonin||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picomole/liter||Standard Deviation|Mean
1362907|NCT01648582|Secondary|Change From Baseline in Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||Units/Liter (U/L)||Standard Deviation|Mean
1362908|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||beats per minute (bpm)||Standard Deviation|Mean
1362909|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||millisecond (msec)||Standard Deviation|Mean
1362910|NCT01648582|Secondary|Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate|Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1362911|NCT01648582|Secondary|Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||millimeters of mercury (mmHg)]||Standard Error|Least Squares Mean
1362912|NCT01648582|Secondary|Number of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks and 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
1362913|NCT01648582|Secondary|Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||events per participant per year||Standard Deviation|Mean
1362914|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks|The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an homeostasis model assessment with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.|||percentage of HOMA2-%S||Standard Error|Least Squares Mean
1362915|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks|The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using a homeostasis model assessment with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
1362916|NCT01648582|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks|Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||mmol/L||Standard Error|Least Squares Mean
1362917|NCT01648582|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1362918|NCT01648582|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|Up to 26 and 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the last observation carried forward (LOCF) method.|||percentage of participants|||Number
1362919|NCT01648582|Secondary|Change From Baseline in HbA1c at 52 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.|Baseline, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1362920|NCT01648582|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1362921|NCT01648530|Primary|Migraine Disability Assessment (MIDAS)|The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged.|12 Months|All qualified participants at Baseline who returned completed survey with positive screening for migraines.|||days||Standard Deviation|Mean
1362922|NCT01648530|Primary|Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)|EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.|Baseline|All qualified participants at Baseline who returned completed survey with positive screening for migraines.|||percentage of participants|||Number
1362923|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)|The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.|6 months||||units on a scale|||Number
1362939|NCT01648452|Primary|Number of Severe Adverse Events at Six Months Post-Implantation|The number of severe adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
1362925|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire|"The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible."|Baseline and 6 months||||units on a scale|||Number
1362926|NCT01648491|Primary|Study-Related Adverse Events||6 months||||Adverse Events|||Number
1362927|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Untreated Control Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
1362928|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Study Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
1362929|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Untreated Control Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
1362930|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Study Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
1362931|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Untreated Control Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .~The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
1362932|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Study Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .~The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
1362933|NCT01648452|Secondary|Number of Non-Ocular Adverse Events at All Time Points Post-Implantation|The total number of non eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
1362934|NCT01648452|Secondary|Number of Ocular Adverse Events at All Time Points Post-Implantation|The total number of eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
1362935|NCT01648452|Secondary|Number of Severe Adverse Events at All Time Points Post-Implantation|"The total number of severe adverse events reported from Day 1 post-implantation through study completion at Year 3.~Although there were two serious adverse events (SAEs) reported during the study, only one event's severity was classified as severe."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
1362936|NCT01648452|Secondary|Number of Adverse Events at All Time Points Post-Implantation|The total number of adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
1362937|NCT01648452|Primary|Number of Non-Ocular Adverse Events at Six Months Post-Implantation|The number of non eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
1362938|NCT01648452|Primary|Number of Ocular Adverse Events at Six Months Post-Implantation|The number of eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
1362941|NCT01648348|Other Pre-specified|Changes in Tumor and Circulating Biomarkers|Binary endpoints and categorical endpoints will be compared using Chi-Squared or Fisher’s Exact tests between treatment groups. Continuous endpoints will be analyzed using change-from-baseline measures and compared using t-tests between treatment groups and time-points. Cox proportional hazards regression will be used to determine if there are differences in PFS and OS between the treatment groups after correcting for each biomarker in conjunction with standard clinical variables.|Baseline to up to 2 years|||||||
1362942|NCT01648348|Other Pre-specified|Change in MRI ADC Utility|MRI ADC histogram metrics such as overall ADC, mean ADC of lower curve, percentage of ADC in lower curve, and skewness at baseline and change from baseline to the first follow-up MRI will be analyzed for association with progression free and overall survival. Kaplan-Meier survival curves, logrank and Cox regression tests will be used to estimate and compare the equality of the overall survival and progression-time distributions of patient subsets defined by the ADC histogram metrics.|Baseline to up to 2 years|||||||
1362943|NCT01648348|Other Pre-specified|Change in DCE-MRI Utility|Associations between the change of DCE-MRI and PFS6 will be assessed using two-sample t-test.|Baseline to up to 2 years|||||||
1362944|NCT01648348|Secondary|QOL Assessed by WIWI Questionnaire (Phase II)|Quality of life (QOL) assessed by Was it worth it? (WIWI) questionnaire, as measured by the percentage of patients answering yes to the question “Was it worthwhile for you to participate in this research study?”|Up to 4 weeks|All phase II patients who completed the WIWI questionnaire were included in this analysis.|||percentage of patients answering yes|||Number
1362945|NCT01648348|Secondary|QOL Assessed by EORTC-QLQ-BN20 Patient Questionnaire [Items 1-20] (Phase II)|QOL assessed by EORTC-QLQ-BN20 Patient Questionnaire (Brain cancer module), as measured by the change from baseline to the end of cycle 2 (4 weeks) in the EORTC QLQ-BN20 Items 1-20 are used to score the following 11 symptom scales: Future uncertainty (Items 1-3,5), Visual disorder (Items 6-8), Motor dysfunction (Items 10,15, 19), Communication deficit (Items 11-13), Headaches (Item 4), Seizures (Item 9), Drowsiness (Item 14), Itchy Skin (Item 17), Hair Loss (Item 16), Weakness of legs (Item 18), and Bladder control (Item 20). The assessment was scored using EORTC's scoring algorithms. The score range for each of the 11 symptom scales is from 0-100 (0 corresponding to not severe;100 corresponding to most severe). Range of changes in scores from baseline to cycle 2 (4 weeks) is (-100,100). The mean change in score and 95% confidence interval of each symptom scale are reported below.|Baseline and 4 weeks|All phase II patients who completed the EORTC-QLQ-BN20 patient questionnaire at baseline and at the end of cycle 2 were included in this analysis.|||units on a scale||95% Confidence Interval|Mean
1362946|NCT01648348|Secondary|Quality of Life (QOL) as Assessed by the EORTC QLQ-C15-PAL Questionnaire [Item 15: Global Health Status/Quality of Life] (Phase II)|Quality of Life (QOL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire, as measured by the change from baseline to the end of cycle 2 (4 weeks) in the EORTC QLQ-C15-PAL item 15, Global health status/quality of life, score. The assessment was scored using EORTC’s scoring algorithms. The score range is from 0-100 (0 corresponding to worst outcome; 100 corresponding to best outcome). Range of the change in scores from baseline to cycle 2 (4 weeks) is (-100,100). The mean change in score and 95% confidence interval of the change from baseline to the end of cycle 2 (4 weeks) are reported below.|Baseline and 4 weeks|All phase II patients who completed the EORTC QLQ-C15-PAL questionnaire at baseline and at the end of cycle 2 were included in this analysis.|||units on a scale||95% Confidence Interval|Mean
1362947|NCT01648348|Secondary|Progression Free Survival at 6 Months (PFS6) (Phase II) as Measured by the Percentage of Participants With Progression Free Survival at 6 Months|PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause (whichever comes first). The medians and confidence intervals given are the Kaplan-Meier estimates.|The time from study randomization to documentation of disease progression, assessed at 6 months|All phase II patients who started the study were eligible and included in this analysis.|||percentage of progression-free patients||95% Confidence Interval|Number
1362948|NCT01648348|Secondary|Overall Survival (Phase II)|Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both groups of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.|The time from start of study therapy to death due to any cause, assessed up to 2 years|All phase II patients who started the study were eligible and included in this analysis.|||months||95% Confidence Interval|Median
1362949|NCT01648348|Secondary|Overall Toxicity Rate for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment (Phase II)|The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment will be compared using a Fisher’s Exact test between the 2 treatment groups.|Up to 2 years|All phase II patients who completed the study were eligible and included in this analysis.|||percentage of patients|||Number
1362950|NCT01648348|Primary|Progression-free Survival (PFS) (Phase II)|Progression Free Survival time is defined as the time from study randomization to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. The time-to-progression distribution will be estimated using the Kaplan-Meier method.|The time from study randomization to documentation of disease progression, assessed up to 2 years|All phase II patients who started the study were eligible and analyzed for the primary outcome of Phase II.|||months||95% Confidence Interval|Median
1363130|NCT01646151|Secondary|Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment|Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.|12 Weeks|All patients|||Percentage of Patients|||Number
1366381|NCT01607645|Secondary|Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction||Assessed for up to 5 years||||Participants|||Count of Participants
1362951|NCT01648348|Primary|Maximum Tolerated Dose (MTD) (Phase I) as Measured by the Number of Participants With Dose Limiting Toxicities|MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience dose-limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of DLT's will be reported here.|28 days|All phase I patients who completed the study were eligible and analyzed for MTD.|||Participants|||Count of Participants
1362952|NCT01648322|Secondary|The Depth of the ANC Nadir for All Chemotherapy Cycles|The depth of ANC nadir for each cycle is defined as the minimal ANC value for a subject in each chemotherapy cycle. The depth of the ANC nadir for each arm of the study will be recorded for 4 chemotherapy cycles.|Measured for each of the 4, 21 day chemotherapy cycles||2019-01-31|01/2019||||
1362953|NCT01648322|Secondary|The Incidence Rates of Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles|The incidence rate of mild, moderate and sever neutropenia for each arm of the study will be recorded for 4 chemotherapy cycles. Each cycle is expected to last 21 Days.|Measured for each of the 4, 21 day chemotherapy cycles.||2019-01-31|01/2019||||
1362954|NCT01648322|Secondary|The Time to ANC Recovery Post Nadir|The time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded; recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration). Each chemotherapy cycle is expected to last 21 days.|Measured for each of the 4, 21 day chemotherapy cycles.||2019-01-31|01/2019||||
1362955|NCT01648322|Secondary|The Duration in Days of Total Grade 2 Neutropenia|Number of says in which the patient has had an ANC Level ANC < 1.5 × 109/L) post each chemotherapy|Measured for each of the 4, 21 day chemotherapy cycles.||2019-01-31|01/2019||||
1362956|NCT01648322|Secondary|The Incidence Rate of Febrile Neutropenia|The incidence rate of febrile neutropenia for each arm of the study will be recorded for 4 chemotherapy cycles. Each cycle is expected to last 21 Days.|Measured for each of the 4, 21 day chemotherapy cycles.||2019-01-31|01/2019||||
1362957|NCT01648322|Secondary|Duration in Days of Grade 3 and Grade 4 Neutropenia for Each of 4 Chemotherapy Cycles.|Number of days In which the patient has had an ANC < 1.0 × 10^9/L (Grade 3) or ANC < .5 × 10^9/L (Grade 4) post each chemotherapy|Measured for each of the 4, 21 day chemotherapy cycles.||2019-01-31|01/2019||||
1362958|NCT01648322|Primary|Duration of Moderate Neurtopenia Post First Chemotherapy Administration|Number of days In which the patient has had an absolute neutrophil count (ANC) Level < 2.0 x 10^9/L after first cycle of chemotherapy|The first of 4, 21 Day Chemotherapy Cycles|per protocol population|||days||Standard Deviation|Mean
1362959|NCT01648283|Primary|Methadone Metabolism|Plasma metabolite EDDP/methadone area under the concentration–time curve (AUC0–96) ratio|up to 96 hours|Plasma EDDP/methadone AUC ratio|||ratio||Standard Deviation|Mean
1362960|NCT01648140|Secondary|Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2|Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Day 2|PK/PD Analysis Population||||||
1362961|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status|Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|PK/PD Analysis Population||||||
1362962|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status|Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4|Intensive PK Population||||||
1362963|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status|Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4|Intensive PK Population||||||
1362964|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status|Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|Intensive PK Population||||||
1362965|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status|Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|Intensive PK Population||||||
1362966|NCT01648140|Secondary|Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||mL/min||Standard Deviation|Mean
1362967|NCT01648140|Secondary|Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimoles per liter||Standard Deviation|Mean
1362968|NCT01648140|Secondary|Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12|The ECG data was only collected “Perform as needed”, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
1362969|NCT01648140|Secondary|Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12|The ECG data was only collected “Perform as needed”, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
1362970|NCT01648140|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12|Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
1362971|NCT01648140|Secondary|Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12|Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
1362972|NCT01648140|Secondary|Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Micromoles per liter||Standard Deviation|Mean
1362984|NCT01648140|Secondary|Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.|Week 4 (24 h post dose)|Intensive PK Summary Population: Intensive PK Summary Population comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1362973|NCT01648140|Secondary|Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||International units per liter||Standard Deviation|Mean
1362974|NCT01648140|Secondary|Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
1362975|NCT01648140|Secondary|Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Femtoliters||Standard Deviation|Mean
1362976|NCT01648140|Secondary|Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Ratio||Standard Deviation|Mean
1362977|NCT01648140|Secondary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
1362978|NCT01648140|Secondary|Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Trillion cells per liter||Standard Deviation|Mean
1362979|NCT01648140|Secondary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Giga cells per liter||Standard Deviation|Mean
1362980|NCT01648140|Secondary|Apparent Volume of Distribution (Vz/F) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.|Week 4 (24 h post dose)|Intensive PK Summary Population|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1362985|NCT01648140|Secondary|Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12|Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.|Day 1, Day 2, Week 4, and Week 12|PK Population included all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1362986|NCT01648140|Secondary|Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)|Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA <LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA <LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.|From the start of the treatment up to PT FU Week 24|ITT Population|||Participants|||Number
1362987|NCT01648140|Secondary|Number of Participants With Any AEs and Any SAEs After Week 12|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From Week 12 up to PT Week 24 FU|Safety Population|||Participants|||Number
1362988|NCT01648140|Primary|Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia’s Formula (QTcF) Values at the Indicated Time Points up to Week 12|The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Milliseconds||Standard Deviation|Mean
1362989|NCT01648140|Primary|Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12|The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
1362990|NCT01648140|Primary|Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12|Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0), Weeks 2 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
1362991|NCT01648140|Primary|Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Milliliter per minute (mL/min)||Standard Deviation|Mean
1363019|NCT01647945|Secondary|Efficacy of Low-dose FK-506 in Pulmonary Arterial Hypertension (PAH) Measured by Change in 6-min Walk Distance (6MWD)|"Change in 6MWD in meter between baseline and 16 weeks~A large number would indicate an increase in exercise capacity"|baseline to 16 weeks|Only subjects were included who finished the 16-week study 3 patients did not finish|||meter||Inter-Quartile Range|Median
1367910|NCT01591616|Secondary|ECGs (QRS Duration)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
1362992|NCT01648140|Primary|Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimoles per liter||Standard Deviation|Mean
1362993|NCT01648140|Primary|Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Micromoles per liter||Standard Deviation|Mean
1362994|NCT01648140|Primary|Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||International units per liter||Standard Deviation|Mean
1362995|NCT01648140|Primary|Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
1362996|NCT01648140|Primary|Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Femtoliters||Standard Deviation|Mean
1362997|NCT01648140|Primary|Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population|||Ratio||Standard Deviation|Mean
1362998|NCT01648140|Primary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
1363131|NCT01646151|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure|||Patients|||Number
1363491|NCT01643668|Secondary|Incidence of Hepatic Veno-occlusive Disease|The number of participants that experienced hepatic veno-occlusive disease (VOD). VOD is a condition in which some of the small veins in the liver are obstructed.|2 years||||Participants|||Count of Participants
1362999|NCT01648140|Primary|Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Trillion cells per liter||Standard Deviation|Mean
1363000|NCT01648140|Primary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Giga cells per liter||Standard Deviation|Mean
1363001|NCT01648140|Primary|Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12|Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
1363002|NCT01648140|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12|Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) up to 12-week treatment period|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1363003|NCT01648140|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment up to Week 12|Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).|||Participants|||Number
1363004|NCT01648140|Primary|Number of Participants Achieving eRVR|eRVR is defined as plasma HCV ribonucleic acid (RNA) <lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.|Week 4 and Week 12|Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.|||Participants|||Number
1363005|NCT01648101|Secondary|Incidence of New Seizure Types During the TrP in Participants Without a History of the Indicated Seizure Types at Baseline|A participant was considered to have new seizure types during the TrP if they experienced a new seizure types (such as SE, myoclonic, absence, secondary generalization) and had no prior history of these seizure types. At Screening, a history of previous seizure types was collected, with “Yes,” “No,” “IS,” “SE,” or “Unknown” being recorded for each of the seizures types. The history of seizure types was updated during the 8-week BP as pre-treatment status. New types of seizures during the TrP were recorded as A1=simple PS with motor signs; AX=simple PS without motor signs; B=complex PS; C=PS evolving to secondary generalized seizures; D1=absence of seizures; D2=myoclonic seizures; D3=clonic seizures; D4=tonic seizures; D5=tonic-clonic seizures; D6=atonic seizures; E=unclassified seizures; and SE=status epilepticus.|From Baseline up to Week 16|ITT Population.|||Number of events|||Number
1363132|NCT01646151|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure|||Patients|||Number
1363133|NCT01646151|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure|||Patients|||Number
1363006|NCT01648101|Secondary|Percentage of Seizure-free Days in the TrP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the TrP (TiP plus MP) / number of applicable days in the TrP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Baseline up to Week 16|ITT Population.|||Percentage of seizure-free days||Standard Deviation|Mean
1363007|NCT01648101|Secondary|Percentage of Seizure-free Days in the MP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the MP / number of applicable days in the MP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Week 4 up to Week 16|ITT Population.|||Percentage of seizure-free days||Standard Deviation|Mean
1363008|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the TrP|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. A participant was considered to be seizure free if they experienced no seizures in the TiP or MP regardless of how long they were in the study."|From Baseline up to Week 16|ITT Population.|||Participants|||Number
1363009|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the MP, ITT Population|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. Participants who did not complete the study or experienced any seizures in the MP were not considered to be seizure free. A participant who completed the study AND had no seizures during the maintenance phase were counted to be seizure free. Also, a completer who only had seizures during the TiP is considered seizure free."|Baseline; Week 4 up to Week 16|ITT Population.|||Participants|||Number
1363010|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP Categorized as: >25% Increase and 0% to 25% Increase|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
1363011|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: >25% Increase and 0% to 25% Increase|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
1363012|NCT01648101|Secondary|Percent Change From Baseline in 28 Day Total POS Frequency During the TrP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
1363134|NCT01646151|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 12|All patients with data for this outcome measure|||Eyes|Participants||Number
1363135|NCT01646151|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1363013|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of >=1 occurrence of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline. There was no theoretical upper limit for worsening. Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial status or not).|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
1363014|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|From Baseline up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others both Titration and Maintenance Phase data were used|||Percent change||Full Range|Median
1363015|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP|The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening.|Baseline; Week 4 up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others, only MP data were used.|||Percent change||Full Range|Median
1363016|NCT01648101|Secondary|Number of Responders From the BP to the Treatment Phase (TrP)|A “responder” is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the TrP (TiP plus MP). The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as “Not Done” during the TrP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not).|From Baseline up to Week 16|Intent-to-Treat (ITT) Population|||Participants|||Number
1363017|NCT01648101|Secondary|Number of Placebo and Retigabine 600 mg Responders During the MP|A “responder” is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the MP, randomly assigned to retigabine 600 mg/day compared to placebo. The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as “Not Done” during the MP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not).|Baseline; Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.|||Participants|||Number
1363018|NCT01648101|Primary|Number of Placebo and Retigabine 900 mg Responders During the Maintenance Phase (MP)|A responder is defined as a par. with >=50% reduction in the 28 day total partial on-set seizure (POS) frequency from the Baseline Phase (BP) to the MP, randomly assigned to retigabine 900 mg/day compared with placebo. The total 28-day POS rate was defined as: (total number of POS over the evaluable period (MP) / number of days of seizure (sz) data in the evaluable period) *28 days. In the event of one or more innumerable seizures (IS) occurring on a day, these were to be counted as an additional 10 seizures for that day, regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of MP minus start date of the MP minus days on which seizures were recorded as “Not done” + 1). Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial or not).|Baseline (BL); Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.|||Participants|||Number
1363020|NCT01647945|Secondary|Number of Combined Clinical Events|"Combined Clinical Events @ 16 weeks:~Number of patients who died Number of patients who got transplanted Number of patients who needed escalation of therapies Number of patients who had worsening of NYHA/WHO classification by at least 1 point Number of patients who require hospitalization for right heart failure~Low numbers would suggest either efficacy of the study drug or slowly progression of disease that is studied during the 16 week study period or short observation period or small study population"|Baseline to 16 weeks|Subjects were included who finished the 16 week study period. A total of 3 participants did not complete the study|||Combined Number of Clinical Events|||Number
1363021|NCT01647945|Primary|Safety of Low-dose FK-506 in PAH|Total number of adverse events measured between baseline and end of study at 18 weeks as reported by study subjects such as nausea/diarrhea, URI, sinus congestion, infection, fluid retention/edema, cough, headache, bronchitis, fatigue, drug reaction/hives, flushing, anxiety, tremor, fever, shingles, SOB, insomnia, pain|18 weeks|all study subjects who started the study|||number of AEs|||Number
1363022|NCT01647737|Primary|Change in Salivary Flow From Baseline|Change in salivary flow in Xerostomic patients using Green tea lozenges|8 weeks|Enrolled subjects completing 8 weeks of treatment|||ml/min||Standard Deviation|Mean
1363023|NCT01647711|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).|28 days|Treated set including patients eligible for MTD determination|||mg|||Number
1363024|NCT01647711|Secondary|Determination of Dosage for Expansion Cohort in Part B|Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.|28 days|Treated set including patients eligible for MTD determination|||mg|||Number
1363025|NCT01647711|Secondary|Cmax of Afatinib on Day 3 of Course 1|Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A|47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)|Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1363026|NCT01647711|Secondary|Objective Response Rate for Patients With EGFR T790M Mutations|"Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): >=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.~This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants."|From first drug administration until last drug administration, up to 420 days|Treated set including participants with EGFR T790M positive mutations|||Percentage of participants|||Number
1363027|NCT01647711|Primary|Percentage of Participants With Dose Limiting Toxicities|Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.|28 days|Treated set including patients eligible for MTD determination|||Percentage of participants|||Number
1363028|NCT01647542|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24|The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.|||mg/dL||Standard Error|Least Squares Mean
1363029|NCT01647542|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|The change between the fasting plasma glucose value collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post baseline value were included|||Milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
1363030|NCT01647542|Secondary|Percentage of Participants With HbA1c <7% at Week 24||Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only Participants with a baseline and at least 1 post baseline value were included.|||Percentage of participants|||Number
1363031|NCT01647542|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full Analysis Set (FAS) included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.|||Percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1363032|NCT01647464|Primary|Renal Video Intensity Units|Video intensity units in the kidney 10 min after completion of a clinically indicated contrast echocardiography study.|10 min||||units on a scale||Standard Deviation|Mean
1363033|NCT01647438|Primary|Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake|Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months|baseline and 6-months||||percentage of kilocalories||Standard Error|Mean
1363034|NCT01647438|Primary|Change in Physical Activity (Minutes/Week)|Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.|baseline and 6-months||||min/week||Standard Error|Mean
1363035|NCT01647282|Secondary|Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.|The gingival crevicular fluid is analyzed biochemically and the levels of inflammatory biomarkers can be determined. Specific biomarkers are inherent in periodontal disease and have been shown to be indicative of periodontal breakdown within a pocket. In this study, the biomarker, IL-1 were assessed for their presence and quantity within the GCF samples taken from the experimental periodontal pockets at baseline and 24 months.|24 months|Patients included had moderate-severe chronic periodontitis with a >/= 5 mm interproximal, posterior pocket that bled upon probing. Participating patients had a history of regular periodontal maintenance therapy and no systemic disease (rheumatoid arthritis, osteoporosis, tetracycline allergy) or medications with bone-turnover significance.|||picograms/mL||Standard Deviation|Mean
1363036|NCT01647282|Primary|Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months|Changes in interproximal bone height loss were measured over the course of 24 months in two groups; patients receiving scaling and root planing alone in a deep periodontal pocket and those receiving scaling and root planing as well as minocycline microspheres in a deep periodontal pocket. These changes in interproximal bone height loss (mm) were determined via bitewing radiographs taken at baseline and 24 months and measured as distance from the cemento-enamel junction to the alveolar bone. Changes in probing depth (mm) were measured from the gingival margin to the depth of periodontal pocket. Changes in clinical attachment level (mm) were determined by adding the measure of gingival recession and the probing depth.|24 months|Patients included had moderate-severe chronic periodontitis with a >/= 5 mm interproximal, posterior pocket that bled upon probing. Participating patients had a history of regular periodontal maintenance therapy and no systemic disease (rheumatoid arthritis, osteoporosis, tetracycline allergy) or medications with bone-turnover significance.|||mm||Standard Deviation|Mean
1363037|NCT01647217|Secondary|Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia|Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).|Baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
1363038|NCT01647217|Primary|Change in the Number of Demodex Mites|"Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered complete eradication. Patients without achieving complete eradication will be categorized as incomplete eradication."|6 weeks||||Mites||Standard Deviation|Mean
1363039|NCT01646827|Secondary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.|This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit.|Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
1363040|NCT01646827|Secondary|Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.|Injection site pain was assessed using a VAS, which was completed by the trial participant, and the investigator’s assessment of most recent injection site, which was completed by the investigator. VAS is 100 mm line, 0=no pain, 100=unbearably painful.|Day 1, Day 14, Day 28 and last visit|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Units on a scale||Standard Deviation|Mean
1363041|NCT01646827|Secondary|Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance|Three 12 lead ECGs were performed approximately 5 minutes apart at each time point. The participant were supine and at rest (for at least 10 minutes) prior to the first ECG and will remain supine through the final ECG. Based on criteria for identifying ECG measurements of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For bradycardia: ≤ 50 beats per minute (bpm); and for increase in QTc: QTc ≥ 450msec.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
1363042|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate|Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of >/= 15 beats per minute were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
1363043|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature|Vital sign assessment included body temperature measured in centigrade(C). Temperatures >=37.8°C and increase of >= 1.1°C were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
1363044|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure|Vital sign assessment included orthostatic (supine and standing) blood pressure. Orthostatic assessments were made after participants had been in the supine position for at least 5 minutes and again after participants had been standing for 2 minutes, but not more than 3 minutes. Orthostatic hypotension defined as >/= 20 mm Hg decrease in systolic blood pressure and >/= 25 beats per minute increase in heart rate from supine to standing.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
1363045|NCT01646827|Secondary|Number of Participants With Laboratory Values of Potential Clinical Relevance.|The laboratory tests were collected and processed in accordance with directions from the clinical chemistry laboratory. Based on criteria for identifying laboratory values of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For fasting triglycerides: men: ≥ 160 mg/dL and women: ≥ 120 mg/dL; Fasting glucose: ≥ 115 mg/dL; Prolactin: > upper limit of normal (ULN); Neutrophils: ≤ 1,500/mm3; and Creatine phosphokinase: ≥ 3 x ULN.|Day 1, Day 28, Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
1363046|NCT01646827|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Starting at the time the ICF was signed to Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
1363095|NCT01646255|Secondary|Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the off state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of days||Standard Deviation|Mean
1363047|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng day/mL||Standard Deviation|Mean
1363048|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng/mL||Standard Deviation|Mean
1363049|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng day/mL||Standard Deviation|Mean
1363050|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Aripriprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng/mL||Standard Deviation|Mean
1363051|NCT01646814|Primary|Incidence of Gastroduodenal Ulcers|Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth|42 Days|Per protocol population (ie, Treated with ≥1 dose and Day 7 dose administered and endoscopy performed and ≥85% compliant)|||participants|||Number
1363052|NCT01646762|Secondary|Overall Response Rate|"Overall response rate (percentage) is defined as the percentage of patients with a partial response (PR) or better. A PR or better will be considered synonymous with success and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = PR + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status. The percentage of successes (PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. PR or better will be evaluated using all cycles of treatment."|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
1363053|NCT01646762|Secondary|Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.|Up to 3 years||||percentage of patients|||Number
1363054|NCT01646762|Secondary|Duration of Response of All Evaluable Patients Who Have Achieved a Partial Response or Better|Duration of response is defined for all evaluable patients who have achieved a partial response or better (stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) ) as the date at which the patients earliest best objective status is first noted to be at least a partial response or better to the earliest date of progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Date at which the patient’s earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years|All evaluable patients who have achieved a (unconfirmed or confirmed) partial response or better at the earliest best objective status are included in this analysis|||months||Full Range|Median
1363136|NCT01646138|Primary|Percent MMID|Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.|67 days after influenza inoculation|Analysis of the subjects who completed the study after receiving a particular dose of Ca/04/2009/H1N1 Vero Grown Challenge Virus.|||percentage of participants|||Number
1363137|NCT01646125|Secondary|Time to Progression (TTP)|TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
1363055|NCT01646762|Secondary|Progression Free Survival at 3 Months|"The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as:~Any one or more of the following: Increase of 25% from lowest value in:~Serum M-component (absolute increase must be ≥ 0.5 g/dl~Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl~Urine M-component (absolute increase must be ≥ 200 mg/24 h)~If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl)~Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder~Development of new soft tissue plasmacytomas or bone lesions~Hypercalcemia (≥11.5 mg/dl)~Decrease in hemoglobin of ≥2 g/dl~Serum creatinine level ≥2 mg/dl"|Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years||||percentage of patients|||Number
1363056|NCT01646762|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
1363057|NCT01646762|Primary|Percentage of Patients Who Have a Confirmed Partial Response or Better|"A confirmed partial response or better will be considered synonymous with success and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status on two consecutive evaluations. The percentage of successes (confirmed PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. Confirmed PR or better will be evaluated using all cycles of treatment."|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
1363058|NCT01646671|Secondary|Percentage of Participants With DBP Response at End of Study|DBP response was defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
1363059|NCT01646671|Secondary|Percentage of Participants With SBP Response at End of Study|SBP response was defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
1363060|NCT01646671|Secondary|Percentage of Participants Achieving Successful msDBP Control at End of Study|Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
1363061|NCT01646671|Secondary|Percentage of Participants Achieving Successful msSBP Control at End of Study|Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
1363062|NCT01646671|Secondary|Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study|Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
1363063|NCT01646671|Secondary|Change From Baseline in msSBP and msDBP at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||mmHg||Standard Deviation|Mean
1363064|NCT01646671|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths|Adverse events, serious adverse events deaths were monitored from screening to week 8.|Week 8|AE analysis was determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category. Other safety analysis was determined by the maximum treatment.|||Percentage of participants|||Number
1363138|NCT01646125|Secondary|Change in Laboratory Paramenters|Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
1363379|NCT01644240|Primary|Cmax|Maximum concentration in plasma following dosing on Day 1|Day 1|Sample size was 6 at all time points with the exception of 0.5 hours for dose 2 where value was considered an outlier and one subject was excluded from the PK analysis resulting in sample size of 5.|||pg/mL||Standard Deviation|Mean
1363065|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1363066|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1363067|NCT01646398|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titer||95% Confidence Interval|Geometric Mean
1363068|NCT01646398|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination|Evaluable immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A.|||percentage of participants||95% Confidence Interval|Number
1363069|NCT01646398|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titer||95% Confidence Interval|Geometric Mean
1363070|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|6 months prior to and 6 months post switching etanercept|FAS population. Here “N” (number of participants analyzed): participants evaluable for this measure, “n”: participants evaluable for specified time-points. Only participants treated with ETN were to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
1363071|NCT01646385|Secondary|Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score <=0.5 were considered in remission state.|Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||percentage of participants|||Number
1363139|NCT01646125|Secondary|Rate of Adverse Events (AEs)|To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
1363140|NCT01646125|Secondary|Duration of Response (DOR)|The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
1363072|NCT01646385|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
1363073|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score at Baseline|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||units on a scale||Standard Deviation|Mean
1363074|NCT01646385|Secondary|Time to Remission|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||years||95% Confidence Interval|Median
1363075|NCT01646385|Secondary|Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||percentage of participants|||Number
1363076|NCT01646385|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline, Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
1363077|NCT01646385|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate [ESR, millimeter per hour] or C-reactive protein [CRP, milligram per liter]) and patient's general health assessment (recorded on a Visual Analog Scale [VAS] of 0 millimeter [mm]-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||units on a scale||Standard Deviation|Mean
1363078|NCT01646385|Secondary|Time on Etanercept Therapy|Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.|||years||95% Confidence Interval|Median
1363079|NCT01646385|Secondary|Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation|Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.|||percentage of participants|||Number
1363141|NCT01646125|Secondary|Time to Response (TRR)|TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
1364162|NCT01637077|Secondary|The Percentage of Patients Who Use Non-prescription Pain Medications|The percentage of patients who use non-prescription pain medications are reported by arm below.|From treatment initiation to 6 months.||||percentage of patients|||Number
1363080|NCT01646385|Primary|Crude Incidence Rate of All-Cause Mortality|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
1363081|NCT01646385|Primary|Crude Incidence Rate of Other Serious Adverse Events|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
1363082|NCT01646385|Primary|Crude Incidence Rate of Serious Infections|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as ‘serious infection’ in the field [serinf] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
1363083|NCT01646385|Primary|Crude Incidence Rate of Lymphoproliferative Malignancy (LM)|Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as ‘lymphoproliferative malignancy’ in the field [lymphopro] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
1363084|NCT01646385|Primary|Crude Incidence Rate of Malignancy|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
1363085|NCT01646320|Secondary|Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis.|From baseline to week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period|||Percentage of subjects|||Number
1363086|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period|||kg||Standard Error|Least Squares Mean
1363087|NCT01646320|Secondary|Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24|2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed is the number of randomized subjects with non-missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Least Squares Mean
1363088|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed corresponds to the number of randomized subjects with non-missing baseline value and at least one post-baseline value.|||mg/dL||Standard Error|Least Squares Mean
1363089|NCT01646320|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1363090|NCT01646268|Secondary|Change in Unified Parkinson’s Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.~The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score ranges from 0 to 108, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1363091|NCT01646268|Secondary|Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score ranges from 0 to 52, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1363092|NCT01646268|Secondary|Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.~The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. A higher score denotes greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||percentage of responders|||Number
1363093|NCT01646268|Primary|Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject’s disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject’s disease state in the “on” state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject’s motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the “on” state.~The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1363094|NCT01646255|Secondary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS Part III Motor Examination) During “on” Periods From Baseline to the End of Double-blind Maintenance Period|"The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability.~A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||units on a scale||Standard Deviation|Mean
1363142|NCT01646125|Secondary|Disease Control Rate (DCR)|Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
1363096|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on without troublesome dyskinesia” state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of days||Standard Deviation|Mean
1363097|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on with troublesome dyskinesia” state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of days||Standard Deviation|Mean
1363098|NCT01646255|Secondary|Change in the Number of “Off” Periods From Baseline to the End of Double-blind Maintenance Period|A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||Number of 'off' Periods||Standard Deviation|Mean
1363099|NCT01646255|Secondary|Percent Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes.~Relative time spent “on” will be calculated in two stages. Each valid daily diary will have an associated relative time “on” calculated as relative time “on” for day = 100*[total absolute time “on” for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time “on” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
1363100|NCT01646255|Secondary|Percent Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
1363101|NCT01646255|Secondary|Change in Relative Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Relative time spent “on” will be calculated in two stages. Each valid daily diary will have an associated relative time “on” calculated as relative time “on” for day = 100*[total absolute time “on” for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time “on” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||hours||Standard Deviation|Mean
1363102|NCT01646255|Secondary|Change in Absolute Time Spent “on” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “on” when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Absolute time “on” is defined as the mean number of hours marked “on” during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||hours||Standard Deviation|Mean
1363143|NCT01646125|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive.|from randomization until death up to death|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
1363103|NCT01646255|Secondary|Percent Change in Relative Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.~Relative time spent “off” will be calculated in two stages. Each valid daily diary will have an associated relative time “off” calculated as relative time “off” for day = 100*[total absolute time “off” for day/ absolute time awake for day]. Relative time spent off is then calculated by averaging the daily relative time “off” for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
1363104|NCT01646255|Secondary|Percent Change in Absolute Time Spent “Off” From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication.~Absolute time “off” is defined as the mean number of hours marked “off” during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
1363105|NCT01646255|Secondary|Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period|A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of participants|||Number
1363106|NCT01646255|Primary|Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period|A subject has been considered “off” when he/she began to lose the optimum effects of anti-Parkinson’s medication. A negative mean indicates a reduction of the time off during the conduct of the study|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||hours||Standard Deviation|Mean
1363107|NCT01646216|Secondary|Walking Speed|Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.|Baseline, post training, and 3 month follow up.|All subjects for whom walk speed was recorded at baseline, post training, and follow up.|||meters per second (m/s)||Standard Deviation|Mean
1363108|NCT01646216|Secondary|Change in Baseline Oxygen Intake|This is the change in metabolic power that is required of a subject to walk at their self selected walking speed on the treadmill. Metabolic power was measured at baseline, post training, and three months after training. We report the difference between post training and baseline and three months and baseline.|Post training (week 14), and 3 months follow up|"One subject in the Split-belt Severe Disability Arm/Group did not complete the assessment during the change at follow up visit. Two subjects in the Tied-belt, Severe Disability Arm/Group were not able to complete the assessments at post training or follow up."|||ml/kg/min||Full Range|Mean
1363109|NCT01646216|Primary|Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.|Subjects will either walk on a special mat that records their step lengths, or will wear special markers on the feet and body to record their step lengths.|After training (week 14), and 3 months after training|Subjects were grouped by baseline walking speed into three levels of disability: mild, moderate, and severe.|||ratio||Full Range|Mean
1363110|NCT01646177|Secondary|Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.|Baseline, Week 12|All randomized participants who received at least one dose of study treatment and had evaluable data.|||Participants|||Number
1363111|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
1363112|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
1363113|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
1363114|NCT01646177|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Means in Patient's Global Assessment of Disease Severity score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of Patient's Global Assessment of Disease Severity.|||Units on a Scale||Standard Error|Least Squares Mean
1363115|NCT01646177|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of SF-36. Participants with missing SF-36 data were imputed by Last Observation Carried Forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1363116|NCT01646177|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The WPAI-PSO is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days. It has four domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 and ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of WPAI-PSO. Participants with missing WPAI-PSO data were imputed by Last Observation Carried Forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1363117|NCT01646177|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS Means in total QIDS-SR16 score were calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of QIDS-SR16. Participants with missing QIDS-SR16 data were imputed by Last Observation Carried Forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1363118|NCT01646177|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score|PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had scalp psoriasis at baseline and had at least one post-dose measurement of PSSI.|||Units on a Scale||Standard Error|Least Squares Mean
1363119|NCT01646177|Secondary|Percent of Body Surface Area (BSA) Involvement of Psoriasis|Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb). LS Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of BSA.|||Percent||Standard Error|Least Squares Mean
1363127|NCT01646177|Primary|Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
1376632|NCT01490931|Primary|Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||5 Hours post-dose||||millimeters||Standard Error|Mean
1363120|NCT01646177|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had fingernail involvement at baseline and had at least one post-dose measurement of NAPSI.|||Units on a Scale||Standard Error|Least Squares Mean
1363121|NCT01646177|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include “not at all,” “a lot,” and “very much,” with corresponding scores of 1, 2, and 3, respectively, and unanswered (“not relevant”) responses scored as “0.” Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of DLQI.|||Units on a Scale||Standard Error|Least Squares Mean
1363122|NCT01646177|Secondary|Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or did not follow the protocol, and had an Itch NRS score >=4 at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
1363123|NCT01646177|Secondary|Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
1363124|NCT01646177|Secondary|Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
1363125|NCT01646177|Secondary|Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician’s determination of the participant’s psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant’s psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
1363126|NCT01646177|Primary|Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
1363144|NCT01646125|Secondary|Overall Response Rate (ORR)|ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time.|16 months|The data monitoring committee's (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||Participants|||Number
1363145|NCT01646125|Primary|Progression Free Survival (PFS)|Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|16 months|Efficacy analysis set (EAS) compromised of a subset of patients in the FAS who received 2 lines of prior antineoplastic therapy consisting of a platinum-based treatment & an EGFR TKI treatment. The DMC recommendation at Interim analysis was to stop the study for futility. As a result, collection of all efficacy assessments was stopped.|||Months||90% Confidence Interval|Median
1363146|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||scores on a scale||Standard Deviation|Mean
1363147|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||scores on a scale||Standard Error|Mean
1363148|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363149|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363150|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363151|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1364253|NCT01636453|Secondary|Number of Participants With Aneurysm Raymond Class I Occlusion Grading|Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.|At 12 months post-implant||||Participants|||Count of Participants
1363152|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period B]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363153|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” or “Minimal” [Period A]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363154|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period B]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363155|NCT01646073|Secondary|Percentage of Participants With a Physician's Global Assessment (PGA) of “Clear” [Period A]|The Physician’s Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363156|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363157|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363158|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]|PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||percent change||Standard Deviation|Mean
1363159|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]|Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); Last observation carried forward (LOCF): used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||Percent change||Standard Error|Mean
1363160|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|Intent to Treat Population B (ITT_B): all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363161|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3 and 7|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363162|NCT01646073|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Week 12|Intent to Treat Population A (ITT_A): all participants who were randomized at Week 0 (Baseline); Non-responder imputation (NRI): any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
1363163|NCT01646021|Other Pre-specified|The Mean Change From Baseline in Euro QoL Five-Dimension (EQ-5D-5L) Scores for Each Post Baseline Assessment|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and possible total score range -0.594 to 1; higher score indicates a better health state.|Baseline, Cycle 2, 3, 4, 5, 6, 7, 8, 11, 14, 17, 20, 28, 36 and End of treatment (approximately up to 23 months)|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants evaluated for this outcome measure.|||Units on scale||Standard Deviation|Mean
1363164|NCT01646021|Other Pre-specified|Days of Hospitalization and Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately up to 28.2 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Days||Standard Deviation|Mean
1363165|NCT01646021|Other Pre-specified|Number of Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately up to 28.2 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Emergency room visits||Standard Deviation|Mean
1363166|NCT01646021|Other Pre-specified|Number of Hospitalizations Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately up to 28.2 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Hospitalizations||Standard Deviation|Mean
1363167|NCT01646021|Other Pre-specified|Number of Participants With Biomarkers That Alter B-cell Receptor (BCR) Signaling or Activate Alternative Signaling Pathways and to Explore Their Association With Response or Resistance to Ibrutinib|Biomarker evaluations to identify markers altering BCR signaling or activate alternative signaling pathways and explore their association with response or resistance to ibrutinib. Next-generation sequencing at baseline identifies possible primary resistance mutations and those found only at progression are acquired mutations on therapy.|Approximately up to 28.2 months||||Participants|||Number
1363168|NCT01646021|Other Pre-specified|Area Under the Plasma Concentration of Ibrutinib During Steady State (AUC-ss)|The AUC-ss is the area under the plasma concentration time curve observed during steady state.|Cycle 1 and 2 (Day 1): Predose, 1, 2, 4 hr. postdose; Cycle 3 (day 1): Predose (Each cycle is of 21 days)|Pharmacokinetic analysis set included the participants who had received one dose of study drug had at least 1 pharmacokinetic sample obtained post-treatment.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1363169|NCT01646021|Other Pre-specified|One Year Survival Rate|One ­year survival rate, defined as the proportion of participants who were alive 1 year after randomization.|Month 12|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Proportion of participants||95% Confidence Interval|Number
1363170|NCT01646021|Other Pre-specified|Extent of Exposure of Time|Extent of exposure is defined as the duration of the treatment administered during the study. Duration of exposure is calculated as the number of months between the start and end of treatment.|Approximately up to 46.8 months|Safety Analyses Set (SAS) population includes all the randomized participants who received at least 1 dose of study agent (ibrutinib or temsirolimus) during the treatment phase.|||Months||Full Range|Median
1363171|NCT01646021|Other Pre-specified|Time to Response|Time to response for participants with CR/PR, defined as the interval between the date of randomization and date of initial documentation of response.|Approximately up to 2.8 years|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Months||Full Range|Median
1363172|NCT01646021|Secondary|Number of Participants Affected With Treatment-emergent Adverse Events|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Time from first dose of study drug until the last dose date + 30 days or the start of a subsequent anti-neoplastic therapy, whichever occur earlier (Approximately up to 4 years)|Safety population included all randomized participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
1363173|NCT01646021|Secondary|Time to Worsening in the Lymphoma Sub Scale of Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)|Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Weeks||95% Confidence Interval|Median
1363174|NCT01646021|Secondary|Progression-Free Survival 2|Progression-free survival 2 defined as the time interval between the date of randomization and date of event, defined as progressive disease as assessed by investigator that started after the next line of subsequent anti-neoplastic therapy (including cross-over to ibrutinib), death from any cause, or the start of the second subsequent anti-neoplastic therapy if no progressive disease was recorded after the first subsequent anti-neoplastic therapy.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
1363175|NCT01646021|Secondary|Time-to-Next Treatment|Time to next treatment was measured from the date of randomization to the start date of any anti-neoplastic treatment subsequent to study treatment.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
1363176|NCT01646021|Secondary|Duration of Response|Duration of response (CR or PR), defined as the duration in days from the date of initial response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. The analysis was based on the investigator assessment.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Months||95% Confidence Interval|Median
1363177|NCT01646021|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the interval between the date of randomization and the date of death from any cause.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
1363178|NCT01646021|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants who achieved either CR or PR as best overall response based on the investigator assessment. CR is Disappearance of all target lesions while PR is greater than or equal to 30 % decrease in the sum of the longest diameter of target lesions and Overall Response (OR) is sum of CR and PR.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Percentage of participants|||Number
1363179|NCT01646021|Primary|Progression Free Survival (PFS)|PFS is defined as the duration in months from the date of randomization to the date of progression disease (PD) or relapse from complete response (CR) or death whichever was reported first and was assessed based on the investigator assessment. Revised Response Criteria for Malignant Lymphoma categorizes the response of the treatment of a patient's tumour to CR (the disappearance of all evidence of disease), Relapsed Disease or PD (Any new lesion or increase by greater than or equal to [>=] 50 percent [%] of previously involved sites from nadir).|Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months)|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
1363180|NCT01645735|Other Pre-specified|Safety Evaluation|Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs|Baseline (Day 0) to Day 49|Safety Population: all randomized subjects who received any amount of IV study drug|||participants|||Number
1363181|NCT01645735|Other Pre-specified|Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population|An overall microbiological outcome was derived based on the subject’s baseline pathogen. As no follow-up specimens were collected at the TOC visit for any subjects, all microbiological outcomes were derived based strictly on clinical outcomes, as either presumed eradication (ie, source specimen was not available to culture and the subject was assessed as clinical cure) , presumed persistence (ie, source specimen was not available to culture and the subject was assessed as a clinical failure), or indeterminate (ie, source specimen was not available to culture and the subject’s clinical response was assessed as indeterminate).|Test of Cure, an average of 3 weeks|mMITT Population: a subset of the MITT Population, including subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline|||participants|||Number
1363196|NCT01645280|Primary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient’s assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).|Week 28|The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.|||percentage of participants|||Number
1363182|NCT01645735|Primary|Clinical Outcome at Test of Cure (TOC) in the MITT Population|"An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:~Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required~Failure: Subjects who meet either of the following criteria:~Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy~Death in which CABP is contributory~Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:~Death in which CABP is clearly noncontributory~Lost to follow-up~Extenuating circumstances precluding classification as a cure or failure~A favorable clinical outcome at Test-of Cure (TOC) was clinical cure."|Test of Cure, an average of 3 weeks|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen)|||participants|||Number
1363183|NCT01645735|Primary|Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population|"Clinical response was defined as meeting all of the following criteria:~Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:~Cough~Dyspnea~Sputum production~Chest pain~Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):~Temperature ≤ 37.8°C~Heart rate ≤ 100 beats/min~Respiratory rate ≤ 24 breaths/min~Systolic blood pressure ≥ 90 mmHg~Oxygen saturation ≥ 90%~Confusion/disorientation absent"|Study Day 4|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of Community-Acquired Bacterial Pneumonia (CABP) with risk factors for Methicillin-Resistant Staphylococcus aureus (MRSA) (excluding those that have a sole atypical pathogen)|||participants|||Number
1363184|NCT01645709|Secondary|Number of Subjects With Adverse Events|Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator|13 weeks|||||||
1363185|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Rescue medication use"|13 weeks|||||||
1363186|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Patient Global Impression of Change (PGIC)"|13 weeks|||||||
1363187|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Response rate"|13 weeks|||||||
1363188|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Difference in the current in-clinic pain intensity using the 0-10 NRS before and after exercise at each visit"|13 weeks|||||||
1363189|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• In-clinic 24-hour recall pain intensity using the 0-10 numerical rating scale (NRS) at each visit"|13 weeks|||||||
1363190|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• WOMAC pain subscale as measured from 2 to 12 weeks post-treatment using an AUC approach"|13 weeks|||||||
1363191|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• WOMAC total and subscale scores for pain, function, and stiffness at each visit"|13 weeks|||||||
1363192|NCT01645709|Primary|Compare Efficacy of Verapmil vs Placebo at Week 4|To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.|4 weeks|||||||
1363193|NCT01645280|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28|The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 28|The m-ITT included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.|||units on scale||Standard Error|Least Squares Mean
1363194|NCT01645280|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient’s Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).|Week 12|The m-ITT population included participants who received at least 1 (partial or complete) dose of study agent.|||percentage of participants|||Number
1363195|NCT01645280|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28|The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|From Baseline to Week 28|The modified-ITT population included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.|||units on scale||Standard Error|Least Squares Mean
1363638|NCT01642082|Secondary|Duration of Survival|Duration of survival is defined as the duration alive from study entry until death or last contact.|Patients are followed every three months for the first two years and then every six months for the next three years.|All eligible and treated patients|||months||90% Confidence Interval|Median
1363197|NCT01645176|Primary|Change in Synovitis|"MRI readings performed independently by two musculoskeletal radiologists, using a semi-quantitative scoring system based on MRI assessment of knee OASynovitis scored using axial & sagittal CE-MRI sequence, while effusion & bone marrow lesions were scored using non-CE-MRI sequences of parent study.~Synovitis defined as enhancing thickened synovium (>2 mm) & was evaluated at nine sites of joint-medial & lateral parapatellar recess, suprapateller, infrapatellar, intercondylar, medial & lateral perimeniscal, & adjacent to anterior & posterior cruciate ligaments (ACL/PCL) in all subjects. Synovial thickness was scored semi-quantitatively based on maximal thickness in any slice at each site as follows: grade 0 if <2mm, grade 1 if 2-4 mm & grade 2 if >4mm. For assessment of whole knee synovitis scores of all sites were summed and categorized: 0-4 normal or equivocal synovitis; 5-8 mild synovitis; 9-12 moderate synovitis & >/= 13 severe synovitis."|baseline and 16 weeks|Participants with osteoarthritis of knee|||units on a scale||Standard Deviation|Mean
1363198|NCT01645111|Primary|Time to Achieve Target MAP|The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg|First 30 minutes of infusion||||minutes||Standard Deviation|Mean
1363199|NCT01645098|Secondary|EtCO2 Change After Dexmedetomidine Loading Dose|Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.||||mmHg||Standard Deviation|Mean
1363200|NCT01645098|Secondary|Oxygen Saturation Change After Dexmedetomidine Loading Dose|Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.||||percentage of oxygen||Standard Deviation|Mean
1363201|NCT01645098|Secondary|Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose|Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.|Baseline to immediately post dexmedetomidine infusion.||||mmHg||Standard Deviation|Mean
1363202|NCT01645098|Secondary|Heart Rate Change After Dexmedetomidine Loading Dose|Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.|Baseline to immediately post dexmedetomidine infusion.||||BPM||Standard Deviation|Mean
1363203|NCT01645098|Primary|Time to Sedation Score of 3-4|The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.|Immediately prior to incision||||minutes||Standard Deviation|Mean
1363204|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Smoking|Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)|one day (there is no follow-up, it is a cross-sectional study)||||percentage of smoking participants|||Number
1363205|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-physical Activity|Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)|one day (there is no follow-up, it is a cross-sectional study)||||percentage of patients physical activity|||Number
1363206|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Age|Analyse disseminated Breast Cancer treatment and clinical profile (age)|one day (there is no follow-up, it is a cross-sectional study)||||years||Standard Deviation|Mean
1363207|NCT01645059|Secondary|Adjuvant Treatment-Node Affectation|"Adjuvant treatment and clinical profile (Node affectation)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)||||percentage of patients node affectation|||Number
1363208|NCT01645059|Secondary|Adjuvant Treatment-Physical Activity|"Adjuvant treatment and clinical profile (Physical activity)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)||||percentage of patients physical activity|||Number
1363209|NCT01645059|Secondary|Adjuvant Treatment and Age|"Adjuvant treatment and clinical profile (age)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)||||years||Standard Deviation|Mean
1363210|NCT01645059|Secondary|The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it si a cross-sectional study)||||percentage of participants|||Number
1363211|NCT01645059|Secondary|Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it is a cross-sectional study)||||percentage of participants||95% Confidence Interval|Number
1363212|NCT01645059|Primary|The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)|General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis|1 day (there is no follow-up, it is a cross-sectional study)||||percentage of participants||95% Confidence Interval|Number
1363213|NCT01644734|Secondary|Change in the Total CAT Score (Value Baseline Minus 3 Months)|The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.|Baseline, 3 months|Patients from FAS|||units on a scale||Standard Deviation|Mean
1363214|NCT01644734|Primary|Number of Patients Maintaining or Improving Their Health Status|The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.|Baseline, 3 months|Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.|||participants|||Number
1363215|NCT01644695|Secondary|Intra and Post-Operative Complications|Record of intra and post operative complications resulting from BARS(bony anchoring reinforcement system) procedure including but not limited to scarring, pain, numbness, intra-abdominal injury, bleeding, death, infection, anesthesia complications, and need for further surgery.|ongoing, average 2.4 years|There were 6 instances of wound dehiscence. There were 2 instances each of infection, necrosis, DVT,hematoma, and neuroma. There was 1 instance each of cellulitis, bowel obstruction, entrapped nerve, and temporary numbness. Further surgery was required 7 times, of which 3 included partial removal of the mesh. 27 complications in total.|||participants|||Number
1363216|NCT01644695|Primary|Recurrence Rate|Evidence of complex incisional hernia recurrence after treatment with BARS procedure.|ongoing, average 2.4 years|Subjects were chosen per protocol according to their candidacy for the BARS procedure. All patients were monitored closely following the operation.|||participants|||Number
1363217|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cUTI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set|||NG/ML||Full Range|Geometric Mean
1363218|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cIAI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set|||NG/ML||Full Range|Geometric Mean
1363219|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set|Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Extended microbiologically evaluable at TOC|||Participant|||Number
1363220|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in mMITT Analysis Set|Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Microbiological modified intent to treat|||Participant|||Number
1363221|NCT01644643|Secondary|The Reason for Treatment Change/Discontinuation in mMITT Analysis Set|Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl)|From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363222|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
1363223|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363224|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2|||Participant|||Number
1363225|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1|||Participant|||Number
1363276|NCT01644500|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable body weight data.|||kilogram (kg)||Standard Error|Least Squares Mean
1363226|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
1363227|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT|||Participant|||Number
1363228|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
1363229|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
1363230|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363231|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363232|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2|||Participant|||Number
1363233|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Extended microbiologically evaluable at FU1|||Participant|||Number
1364254|NCT01636453|Secondary|Number of Device Migrations|Migration is defined as movement of the Liberty stent by more than 5 mm as documented by the 12 month angiogram when compared to its immediate post-implant position.|12 months post-implant||||Participants|||Count of Participants
1363234|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in EME at TOC Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
1363235|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in EME at EOT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT|||Participant|||Number
1363236|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
1363237|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
1363238|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363239|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in mMITT Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363240|NCT01644643|Secondary|Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set|Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2|||Participant|||Number
1363241|NCT01644643|Secondary|Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set|Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1|||Participant|||Number
1363242|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
1363243|NCT01644643|Secondary|Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set|Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT|||Participant|||Number
1363244|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363245|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
1363246|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363247|NCT01644643|Secondary|Clinical Response at FU2 in EME at FU2 Analysis Set|Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended Microbiological Evaluable at FU2 analysis set.|||Participant|||Number
1363248|NCT01644643|Secondary|Clinical Response at FU1 in EME at FU1 Analysis Set.|Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended Microbiological Evaluable at FU1 analysis set.|||Participant|||Number
1363249|NCT01644643|Secondary|Clinical Response at TOC in EME at TOC Analysis Set.|Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at TOC analysis set.|||Participant|||Number
1363250|NCT01644643|Secondary|Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at EOT analysis set.|||Participant|||Number
1363251|NCT01644643|Secondary|Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
1363252|NCT01644643|Secondary|Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
1363253|NCT01644643|Secondary|Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363254|NCT01644643|Primary|Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set|Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
1363255|NCT01644617|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an AE|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment (Up to 24 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment|||Percentage of Participants|||Number
1363256|NCT01644617|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment|||Percentage of participants|||Number
1363257|NCT01644617|Secondary|Change From Baseline in HDM-specific IgG4 Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at baseline and Week 8. IgG4 levels were expressed in Log 10 scale mg/L. Mean Week 8 IgG4 levels were compared to the mean IgG4 levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Time Frame: Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 mg/L||95% Confidence Interval|Least Squares Mean
1363258|NCT01644617|Secondary|Change From Baseline in HDM-specific IgE Levels at Week 8|D. pteronyssinus and D. farinae serum IgE levels were measured using the Immunocap® assay at baseline and Week 8. IgE levels were expressed in Log 10 scale kU/L. Mean Week 8 IgE levels were compared to the mean IgE levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 kU/L||95% Confidence Interval|Least Squares Mean
1363259|NCT01644617|Secondary|HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at Week 8. IgG4 levels were expressed in Log 10 scale milligrams/Liter (mg/L). Analysis was based on the ANOVA model with treatment as the fixed effect and reported as mean IgG4 with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 mg/L||Standard Deviation|Mean
1363260|NCT01644617|Secondary|HDM-specific Immunoglobulin E (IgE) Levels at Week 8|Dermatophagoides pteronyssinus (D. pteronyssinus) and Dermatophagoides farinae (D. farinae) serum IgE levels were measured using the Immunocap® assay at Week 8. IgE levels were expressed in Log 10 scale kilo units/Liter (kU/L). Analysis was based on the analysis of variance parametric (ANOVA) model with treatment as the fixed effect and reported as mean IgE with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 kU/L||Standard Deviation|Mean
1363277|NCT01644500|Secondary|Change From Baseline in Heart Rate From ECG at 26 Weeks||Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ECG data.|||bpm||Standard Deviation|Mean
1363279|NCT01644500|Secondary|Change From Baseline in Sitting Pulse Rate at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline pulse rate as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1363261|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 8|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 8 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363262|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 16|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 16 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363263|NCT01644617|Secondary|Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 24 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363264|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 8 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363265|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 16 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363266|NCT01644617|Secondary|Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 24 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363278|NCT01644500|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ECG data.|||milliseconds (msec)||Standard Deviation|Mean
1363267|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 8|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 8 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363268|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 16|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 16 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363269|NCT01644617|Primary|Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1363270|NCT01644500|Secondary|Visual Analog Scale (VAS) Score at 26 Weeks|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life and consists of a 100-milliliter (mm) visual analog scale (VAS) on which the participant rated their perceived health state on that day from 0-mm (worst imaginable health state) to 100-mm (best imaginable health state).|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable VAS data.|||units on a scale||Standard Deviation|Mean
1363271|NCT01644500|Secondary|European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 5 response categories is summarized for each of the 5 dimensions.|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable EQ-5D data.|||participants|||Number
1363272|NCT01644500|Secondary|Number of Participants With Adjudicated Pancreatitis|The number of adjudicated (by an independent committee of expert physicians) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||participants|||Number
1363273|NCT01644500|Secondary|Number of Participants With Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs that were adjudicated included myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||number of participants|||Number
1363274|NCT01644500|Secondary|Percentage of Participants Developing Antibodies to Dulaglutide|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline and 26 weeks. A participant was considered to have treatment-emergent dulaglutide ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ADA data.|||percentage of participants|||Number
1363275|NCT01644500|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable BMI data.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
1403423|NCT01234675|Primary|Sleep Efficiency|Percentage of Total sleep time|Overnight PSG week 5/ upto week 12; milnacipran treatment||||Percentage of total sleep time||Standard Error|Mean
1363280|NCT01644500|Secondary|Change From Baseline in Sitting Blood Pressure at 26 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline blood pressure as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1363281|NCT01644500|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks||Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable serum calcitonin data.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
1363282|NCT01644500|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement and had evaluable pancreatic enzyme data.|||units per liter (u/L)||Standard Deviation|Mean
1363283|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks|Change from baseline in HOMA2-%S was assessed by using the HOMA to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an ANCOVA model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.|||percentage of HOMA2-%S||Standard Error|Least Squares Mean
1363284|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks|Change from baseline in HOMA2-%B was assessed by using the homeostasis model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses FBG, insulin, and C-peptide concentrations to estimate steady state β-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an analysis of covariance (ANCOVA) model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
1363285|NCT01644500|Secondary|Number of Participants With Self-Reported Hypoglycemic Episodes|The overall number of participants with self-reported hypoglycemic episodes is presented.|Baseline through 26 Weeks|All participants who were randomized and received at least one dose of study drug.|||participants|||Number
1363286|NCT01644500|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 milligrams per deciliter (mg/dL) (≤3.9 mmol/L). A severe hypoglycemic episode was defined as any hypoglycemic event for which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Log mean rates of total hypoglycemia (per 30 days per participant) are presented and were calculated from negative binomial regression model. The model included country/region, prior medication group, treatment, visit, and treatment-by-visit interaction. The logarithm of days between visits was adjusted as an offset to account for possible unequal duration between visits and between participants.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, and had evaluable hypoglycemic data.|||episodes/participant/30 days||Standard Deviation|Mean
1363287|NCT01644500|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks|Change from baseline in mean daily blood glucose (BG) values were measured with a 7-point SMBG profile. Participants recorded their 7-point SMBG profiles on 2 separate, non-consecutive days during the 2-week period immediately before randomization, Week 8, Week 16, and Week 26 (or the Early Discontinuation Visit). The 7-point SMBG profile consisted of pre-prandial BG measures before the morning (fasting), midday, and evening meals; BG measures 2 hours after the start (post-prandial) of the morning, midday, and evening meals; and BG measures at bedtime. Mean at 26 weeks was assessed in all treatment groups. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||mmol/L||Standard Error|Least Squares Mean
1363288|NCT01644500|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|FBG is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. FBG was measured by a central laboratory. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline FBG as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1363289|NCT01644500|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks|Percentages of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
1364224|NCT01636778|Secondary|Number of Participants Who Discontinued Antiviral Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1363290|NCT01644500|Primary|Change From Baseline in HbA1c at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||percentage of HbA1c||Standard Error|Least Squares Mean
1363291|NCT01644474|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.|||percent change||Standard Error|Mean
1363292|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on­ or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
1363293|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1363294|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1363295|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1363296|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363297|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on­ or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363298|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
1363299|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|Up to Week 24|ITT population.|||percentage of participants|||Number
1363300|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were included in the imputation model.|Up to Week 24|ITT population.|||percentage of participants|||Number
1363301|NCT01644474|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363302|NCT01644474|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363303|NCT01644474|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Apo-B ITT population.|||percent change||Standard Error|Least Squares Mean
1363304|NCT01644474|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on­ or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363305|NCT01644474|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on­ or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363322|NCT01644396|Other Pre-specified|Change From Baseline in Glucose|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
1363306|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on­ or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1363307|NCT01644474|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
1363308|NCT01644474|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
1363309|NCT01644396|Other Pre-specified|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.~The investigator rated the severity of each AE as either:~Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities.~Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening.~A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.~Drug-related AEs are those assessed by the investigator as either probably or possibly related.~Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma."|From the first dose of study drug until 70 days after the last dose (up to 33 weeks).||||participants|||Number
1363310|NCT01644396|Other Pre-specified|Change From Baseline in Body Temperature|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||degrees celsius||Standard Deviation|Mean
1363311|NCT01644396|Other Pre-specified|Change From Baseline in Weight|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||kg||Standard Deviation|Mean
1363312|NCT01644396|Other Pre-specified|Change From Baseline in Respiratory Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||respirations per minute||Standard Deviation|Mean
1363313|NCT01644396|Other Pre-specified|Change From Baseline in Pulse|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||beats per minute||Standard Deviation|Mean
1363314|NCT01644396|Other Pre-specified|Change From Baseline in Blood Pressure|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)||||mm Hg||Standard Deviation|Mean
1363315|NCT01644396|Other Pre-specified|Change From Baseline in Urine Specific Gravity|Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||ratio||Standard Deviation|Mean
1363316|NCT01644396|Other Pre-specified|Change From Baseline in Urine pH|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||pH units||Standard Deviation|Mean
1363317|NCT01644396|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mg/L||Standard Deviation|Mean
1363318|NCT01644396|Other Pre-specified|Change From Baseline in Triglycerides|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
1363319|NCT01644396|Other Pre-specified|Change From Baseline in Cholesterol|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
1363320|NCT01644396|Other Pre-specified|Change From Baseline in Total Protein|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||g/L||Standard Deviation|Mean
1363321|NCT01644396|Other Pre-specified|Change From Baseline in Albumin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||g/L||Standard Deviation|Mean
1363374|NCT01644240|Primary|AUCtau|Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.|Day 1||||pg*hr/mL||Standard Deviation|Mean
1363323|NCT01644396|Other Pre-specified|Change From Baseline in Calcium, Sodium and Potassium|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
1363324|NCT01644396|Other Pre-specified|Change From Baseline in Inorganic Phosphate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
1363325|NCT01644396|Other Pre-specified|Change From Baseline in Uric Acid|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||µmol/L||Standard Deviation|Mean
1363326|NCT01644396|Other Pre-specified|Change From Baseline in Blood Urea Nitrogen (BUN)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
1363327|NCT01644396|Other Pre-specified|Change From Baseline in Creatinine|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||µmol/L||Standard Deviation|Mean
1363328|NCT01644396|Other Pre-specified|Change From Baseline in Total Bilirubin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||µmol/L||Standard Deviation|Mean
1363329|NCT01644396|Other Pre-specified|Change From Baseline in Alkaline Phosphatase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||U/L||Standard Deviation|Mean
1363330|NCT01644396|Other Pre-specified|Change From Baseline in Aspartate Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||U/L||Standard Deviation|Mean
1363331|NCT01644396|Other Pre-specified|Change From Baseline in Alanine Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||U/L||Standard Deviation|Mean
1363332|NCT01644396|Other Pre-specified|Change From Baseline in Erythrocyte Sedimentation Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mm/hour||Standard Deviation|Mean
1363333|NCT01644396|Other Pre-specified|Change From Baseline in Blood Cell Counts|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||× 10^9 cells/L||Standard Deviation|Mean
1363334|NCT01644396|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.~Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Week 24|Intent-to-treat population who had a NAPSI score ≥ 0 at the Baseline visit; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1363335|NCT01644396|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Weeks 8, 12, and 24|Intent-to-treat population with available data; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1363336|NCT01644396|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.~Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1363337|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 100 Response|The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder analysis was used.|||percentage of participants|||Number
1363338|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 90 Response|The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
1363339|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 75 Response|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, and 16|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
1363340|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 50 Response|The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
1363341|NCT01644396|Secondary|Percentage of Participants Achieving a One Grade Improvement in Physician’s Global Assessment (PGA)|"The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a shift from Baseline to a less severe category is reported."|Baseline and Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
1363342|NCT01644396|Secondary|Percentage of Participants Achieving a Physician’s Global Assessment of Clear or Minimal|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
1363343|NCT01644396|Secondary|Percentage of Participants Achieving a Physician’s Global Assessment of Clear|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a PGA score of clear (0) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
1363344|NCT01644396|Other Pre-specified|Change From Baseline in Red Blood Cell Count|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||× 10^12 cells/L||Standard Deviation|Mean
1363375|NCT01644240|Primary|AUC0-∞|Area under the concentration time curve from time 0 to infinity.|Day 1||||pg*hr/mL||Standard Deviation|Mean
1363345|NCT01644396|Other Pre-specified|Change From Baseline in Hematocrit|Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma).|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||liters/liter||Standard Deviation|Mean
1363346|NCT01644396|Other Pre-specified|Change From Baseline in Hemoglobin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||g/L||Standard Deviation|Mean
1363347|NCT01644396|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 24|Intent-to-treat population; non-responder imputation (NRI) was used, where participants with a missing value were counted as a non-responders.|||percentage of participants|||Number
1363348|NCT01644331|Secondary|All Cause Death or Rehospitalization|All cause death or rehospitalization (to include unscheduled clinic visits or ED visits) at 30 days (Kaplan-Meier and 95% confidence interval)|30 days|baseline population|||proportion of participants||95% Confidence Interval|Mean
1363349|NCT01644331|Secondary|Days Hospitalized or Deceased|Total days hospitalized or deceased during the 30 days after randomization|30 days|baseline population|||days||Standard Deviation|Mean
1363350|NCT01644331|Secondary|Development of Worsening Renal Function|increase in serum creatinine ≥ 0.3mg/dl from randomization at any time point during 72 hours after randomization|72 hours|baseline population|||Participants|||Count of Participants
1363351|NCT01644331|Secondary|Freedom From Congestion|Jugular Venous Pressure (JVP) < 8 cm, no orthopnea, trace peripheral edema or less, and will be assessed at 24, 48, and 72 hours|24, 48, and 72 hours|baseline population|||Participants|||Count of Participants
1363352|NCT01644331|Secondary|Dyspnea 11 Point NRS|Change in NRS for assessment of dyspnea from baseline to 24, 48, and 72 hours (scale ranges from 0-No difficulty breathing to 10-Difficulty as bad as you can imagine)|0, 24, 48, and 72 hours|baseline population|||units on a scale||Standard Deviation|Mean
1363353|NCT01644331|Secondary|Serum Sodium|Change in serum sodium from baseline to 24, 48, and 72 hours|0, 24, 48, and 72 hours|baseline population|||mmol/L||Standard Deviation|Mean
1363354|NCT01644331|Secondary|Over-diuresis|clinical evidence of volume depletion requiring intervention other than holding diuretics during the 72 hours after randomization|72 hours|baseline population|||Participants|||Count of Participants
1363355|NCT01644331|Secondary|Worsening or Persistent Heart Failure or Death|Number of patients with worsening heart failure or death|72 hrs|baseline population|||Participants|||Count of Participants
1363356|NCT01644331|Secondary|Hospital Stay|Total days spent in hospital from baseline until discharge or death|7 days|baseline population|||days||Standard Deviation|Mean
1363357|NCT01644331|Secondary|Dyspnea Likert|Number of patients that experience moderate or greater improvement (patient reported) in dyspnea by 7 point Likert scale at 48 and 72 hours|48 and 72 hours|baseline population|||Participants|||Count of Participants
1363358|NCT01644331|Secondary|Fluid Loss|Change from baseline fluid balance at 24, 48, and 72 hours|0, 24, 48, and 72 hours|baseline population|||mL||Standard Deviation|Mean
1363359|NCT01644331|Secondary|Weight Loss|Change in body weight from baseline to 24, 48, and 72 hours|0, 24, 48, and 72 hours|Baseline population|||lbs||Standard Deviation|Mean
1363360|NCT01644331|Secondary|Renal Function|Change in Serum creatinine from baseline to 24, 48 and 72 hours|0, 24, 48 and 72 hours|Baseline population|||mg/dL||Standard Deviation|Mean
1363361|NCT01644331|Primary|Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours|The number of patients with at least moderate improvement (as reported by patient) in dyspnea Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.|8 and 24 hours|Baseline population|||Participants|||Count of Participants
1363362|NCT01644292|Primary|Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score|The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed.|Baseline and follow-up (1 month)||||units on a scale||Standard Deviation|Mean
1363363|NCT01644240|Primary|CLss|Apparent clearance|Day 5||||L/hr||Standard Deviation|Mean
1363364|NCT01644240|Primary|Vss|Apparent volume of distribution at steady state|Day 5||||L||Standard Deviation|Mean
1363365|NCT01644240|Primary|AUCtau|Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.|Day 5||||pg*hr/mL||Standard Deviation|Mean
1363366|NCT01644240|Primary|AUC0-∞|Area under the plasma concentration time curve from 0 to infinity.|Day 5||||pg*hr/mL||Standard Deviation|Mean
1363367|NCT01644240|Primary|AUC0-24|Area under the plasma concentration time curve 24 hours following the last dose.|Day 5||||pg*hr/mL||Standard Deviation|Mean
1363368|NCT01644240|Primary|t½|Time to 50% plasma concentration|Day 5||||hours||Standard Deviation|Mean
1363369|NCT01644240|Primary|Tmax|Time to reach maximum plasma concentration.|Day 5||||hours||Full Range|Median
1363370|NCT01644240|Secondary|Number of Subjects With Adverse Events||1 week||||participants|||Number
1363371|NCT01644240|Primary|Cmax|Maximum plasma concentration|Day 5||||pg/mL||Standard Deviation|Mean
1363372|NCT01644240|Primary|Plasma CL|Plasma clearance|Day 1||||L/hr||Standard Deviation|Mean
1363373|NCT01644240|Primary|Plasma Vz|Volume of distribution|Day 1||||Liters||Standard Deviation|Mean
1363376|NCT01644240|Primary|AUC0-24|Area under the plasma concentration time curve through 24 hours after dosing.|Day 1||||pg*hr/mL||Standard Deviation|Mean
1363380|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 – On-Treatment Analysis|Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 104|mITT population.|||Percent change||Standard Error|Least Squares Mean
1363381|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis|Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.|From Baseline to Week 104|ITT population.|||Percent change||Standard Error|Least Squares Mean
1363382|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.|||Percent change||Standard Error|Least Squares Mean
1363383|NCT01644188|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1363384|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1363385|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363386|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1363387|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
1363388|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1363389|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363390|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1363391|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|Up to Week 52|mITT population.|||percentage of participants|||Number
1363392|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
1363393|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1363394|NCT01644188|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population|||percent change||Standard Error|Least Squares Mean
1363395|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363396|NCT01644188|Secondary|Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo-B ITT population.|||percent change||Standard Error|Least Squares Mean
1364225|NCT01636778|Secondary|Time to First Dose Reduction of Antiviral Therapy in Part 2|Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||weeks||Standard Deviation|Mean
1363397|NCT01644188|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363398|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline up to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
1363399|NCT01644188|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363400|NCT01644188|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population).|||percent change||Standard Error|Least Squares Mean
1363401|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population).|||percent change||Standard Error|Least Squares Mean
1363402|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1363403|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1363404|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL­-C at Week 24 - On­-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1363405|NCT01644188|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1363406|NCT01644175|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1363407|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1363408|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363409|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1363410|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
1363411|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed be robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1364255|NCT01636453|Secondary|Number of Device Deployment Failures|Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm|During the procedure||||Participants|||Count of Participants
1363412|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363413|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1363414|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
1363415|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
1363416|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1363417|NCT01644175|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363418|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1363419|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1363420|NCT01644175|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363421|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
1363422|NCT01644175|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1363423|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
1363424|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1363425|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1363426|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1363427|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1367911|NCT01591616|Secondary|ECGs (PR Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
1363428|NCT01644175|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1363429|NCT01644058|Primary|Oral-health-related Quality of Life With the Immediate Loading Protocol|Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.|4 months||||units on a scale||Standard Deviation|Mean
1363430|NCT01644058|Primary|Patient Satisfaction With the Immediate Loading Protocol|Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).|4 months||||millimeters||Standard Deviation|Mean
1363431|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 3|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Score on a scale||Standard Deviation|Mean
1363432|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 2|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Score on a scale||Standard Deviation|Mean
1363433|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 1|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Score on a scale||Standard Deviation|Mean
1363434|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire – Disability Index (HAQ-DI) - by the End of Course 3|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363443|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Assessment of Arthritis Pain - by the End of Course 3|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363914|NCT01639742|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
1363435|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire – Disability Index (HAQ-DI) - by the End of Course 2|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363436|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire – Disability Index (HAQ-DI) - by the End of Course 1|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question’s difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363437|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician’s Global Assessment of Arthritis - by the End of Course 3|The investigator assessed how the participant’s overall arthritis appeared at the time of the visit. This evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363438|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician’s Global Assessment of Arthritis - by the End of Course 2|The investigator assessed how the participant’s overall arthritis appeared at the time of the visit. This evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363439|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician’s Global Assessment of Arthritis - by the End of Course 1|The investigator assessed how the participant’s overall arthritis appeared at the time of the visit. This evaluation was based on the participant’s disease signs, functional capacity and physical examination, and was independent of the Patient’s Global Assessment of Arthritis. The investigator’s response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363440|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Global Assessment of Arthritis - by the End of Course 3|Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363441|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Global Assessment of Arthritis - by the End of Course 2|Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363442|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Global Assessment of Arthritis - by the End of Course 1|Participants were asked the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363915|NCT01639729|Primary|CST 1/2|time for maximum plasma concentration to decrease by 50%|24 hours|The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: CST½ (n=16).|||hours||Full Range|Median
1363444|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Assessment of Arthritis Pain - by the End of Course 2|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363445|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient’s Assessment of Arthritis Pain - by the End of Course 1|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
1363446|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
1363447|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
1363448|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
1363449|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
1363450|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
1363451|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
1363452|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
1363576|NCT01642407|Secondary|Number of Participants With Ocular Examination Abnormalities|Ocular examination measures included external examination of the eye, funduscopy, assessments of visual acuity, and color vision. Ocular examination findings were considered abnormal based on investigator’s decision.|Baseline up to Week 16|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1363453|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
1363454|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
1363455|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
1363456|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
1363457|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
1363458|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of participants|||Number
1363459|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of participants|||Number
1363460|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of participants|||Number
1363461|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
1363603|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 1 hour||||percent change||95% Confidence Interval|Mean
1363462|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
1363463|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
1363464|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
1363465|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
1363466|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
1363467|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
1363468|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
1363479|NCT01643928|Primary|Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay|Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).|mITT Population. Only participants with a positive ADA status were included in the analysis.||||||
1363633|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
1363469|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
1363470|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Units on a scale||Standard Deviation|Mean
1363471|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Units on a scale||Standard Deviation|Mean
1363472|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient’s global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Units on a scale||Standard Deviation|Mean
1363473|NCT01643928|Primary|Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement|Blood samples were obtained to determine anti-CCP and compliment levels in serum.|Week 1 and 25 (Course 1, Course 2, and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||U/mL||Standard Deviation|Mean
1363474|NCT01643928|Primary|Circulating Rheumatoid Factor (RF) Concentrations|RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.|Week 1 and 25 (Course 1, Course 2, and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||international units per milliliter||Standard Deviation|Mean
1363475|NCT01643928|Primary|Circulating Immunoglobulin M (IgM) Concentrations|Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.|Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||g/L||Standard Deviation|Mean
1363476|NCT01643928|Primary|Circulating Immunoglobulin G (IgG) Concentrations|Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.|Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||grams per liter (g/L)||Standard Deviation|Mean
1363477|NCT01643928|Primary|Cluster of Differentiation 19 (CD19+) B Cell Count|Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.|Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||cells per microliter||Full Range|Median
1363478|NCT01643928|Primary|Mean Rituximab Serum Trough Concentrations|Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||nanograms per milliliter||Standard Deviation|Mean
1363490|NCT01643668|Secondary|Grade 3 or 4 Toxicities|The number of participants that experienced the specified grade 3 and 4 non-hematological toxicities during treatment and follow-up as assessed by Common Terminology Criteria for Adverse Events version 4(CTAE v 4.0). Grade 3 toxicity is considered to be severe and grade 4 is considered to be life threatening.|2 years||||Participants|||Count of Participants
1363480|NCT01643928|Primary|Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay|Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).|mITT Population. Only participants with a positive ADA status were included in the analysis.||||||
1363481|NCT01643928|Primary|Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay|Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.|Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.|mITT population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.|||Percentage of Participants|||Number
1363482|NCT01643928|Primary|Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay|Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.|Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.|Modified intent-to-treat (mITT) population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.|||Percentage of Participants|||Number
1363483|NCT01643902|Secondary|Functional Outcome by the Modified Rankin Scale at 90 Days|"The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6.~0, no symptoms at all.~no significant disability despite symptoms; able to carry out all usual duties and activities.~slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.~moderate disability; requiring some help, but able to walk without assistance.~moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.~severe disability; bedridden, incontinent and requiring constant nursing care and attention.~dead."|90 days||||units on a scale||Full Range|Mean
1363484|NCT01643902|Primary|Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment|"Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison.~ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline.~NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage."|within 36 hours of treatment|No symptomatic intracerebral hemorrhage was observed by either NINDS IV tPA trial or ECASS 3 criteria.|||participants|||Number
1363485|NCT01643876|Secondary|Candida Species Count|Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.|3 months||||colony forming units (CFUs)||Full Range|Median
1363486|NCT01643876|Primary|Palatal Inflammation|"Modified Newton classification 0: Healthy mucosa~1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation~Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue~Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue~Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index~0: Normal tissue~Mild inflammation~Moderate inflammation~Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)"|3 months||||units on a scale||Full Range|Median
1363487|NCT01643798|Primary|Change in BOLD Signal in Pain Processing Regions During Pain, Including Supraspinal Opioidergic Structures|There are two experimental visits separated by one week. During each experiment, blood oxygen level dependent (BOLD) signal will be measured at baseline (60 minutes into the experiment), post-sham rTMS (90 minutes into the experiment) and post-real (120 minutes into the experiment).|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)||||mean percentage of BOLD signal change||Standard Error|Mean
1363488|NCT01643798|Primary|Pain Rating|"There are two experimental visits separated by one week. During each experiment, pain ratings will be measured every 30 minutes. Preliminary testing will be done 30 minutes into the experiment. The purpose of preliminary testing is to select the temperature that will be used to induce pain throughout the experiment. Baseline testing will be done 60 minutes into the experiment. After sham rTMS will be done 90 minutes into the experiment. After real rTMS will be done 120 minutes into the study. The pain scale used in a Visual Analog Scale (VAS). There was an 11-point rating system where 0 represented no pain and 10 represented unbearable pain."|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)||||units on a scale||Standard Error|Mean
1363489|NCT01643668|Secondary|Infection-related Complications|The number of patients with infection-related complications|2 years||||Participants|||Count of Participants
1363916|NCT01639729|Primary|Tmax|time to maximum plasma concentration|24 hours||||hours||Full Range|Median
1363492|NCT01643668|Secondary|Cumulative Incidence of Chronic GVHD at One Year|The percentage of participants who experienced chronic Graft Versus Host Disease (GVHD) by one year. GVHD is a condition that can occur following an allogenic stem cell transplantation when the donated bone marrow or peripheral stem cells view the recipients body as foreign and the donated cell/marrow attack the body. Chronic GVHD normally occurs after the first 100 days post transplantation. Chronic GVHD can adversely influence long term survival.|1 year||||percentage of participants||95% Confidence Interval|Number
1363493|NCT01643668|Secondary|Cumulative Incidence and Severity of Acute GVHD Within 100 Days Post Transplant|The percentage of participants who experienced grades 2-4 and grades 3-4 acute graft-versus-host disease (GVHD) by 100 days post transplantation. GVHD is a condition that can occur following an allogenic stem cell transplantation when the donated bone marrow or peripheral stem cells view the recipients body as foreign and the donated cell/marrow attack the body. Acute GVHD is generally observed within the first 100 days post transplant. Acute GVHD is associated with increased treatment related morbidity and mortality. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. The grade of the GVHD is determined by grading GHVD associated adverse events. Associated adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4 which uses the same mild, moderate, severe, life threatening grading system as the overall GHVD assessment.|100 days||||percentage of Participants||95% Confidence Interval|Number
1363494|NCT01643668|Secondary|Progression-Free and Overall Survival|The 1-year and 2-year progression-free and overall survival measured from the time of stem cell transplantation. Progression is the recurrence or increase in the number of cancer cells found in the body.|1 year, 2 years||||percentage of participants||95% Confidence Interval|Number
1363495|NCT01643668|Secondary|Cumulative Incidence of Non-relapse Mortality|The percentage of participants that experienced non-relapse mortality (NRM) at day 100 and 1 year after BuClo RIC SCT. Non-relapse mortality is any mortality that is not associated with or proceeded by disease progression of prior cancers.|100 days, 1 year||||percentage of participants who died||95% Confidence Interval|Number
1363496|NCT01643668|Primary|Donor Stem Cell Engraftment: Platelet Count|Platelet recovery was defined as having a platelet count of at least 20,000 platelets/uL of blood on 2 consecutive measurements without transfusional support prior to day +100 after BuClo RIC HSCT.|1, 2, 3, 4, 8, and 14 weeks post transplant|One participant experienced early death before engraftment. Outcome measure was assessed among the remaining 33 evaluable participants.|||Participants|||Count of Participants
1363497|NCT01643668|Primary|Assessment of Donor Stem Cell Engraftment: ANC Count|Patients are considered to have achieved donor cell engraftment if they have an absolute neutrophil count (ANC) of at least 500 cells/uL of blood for 3 consecutive measurements and at least 75% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood prior to day +40 after Busulfan/Clofarabine (BuClo) reduced intensity allogeneic stem cell transplantation|1, 2, 3, and 4 weeks after transplantation|One participant experienced early death before engraftment. Outcome measure was assessed among the remaining 33 evaluable participants.|||Participants|||Count of Participants
1363498|NCT01643616|Primary|Success Rate With Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation"|later than 30-60 minutes after injection of the local anesthetic||||participants|||Number
1363499|NCT01643616|Primary|Time Until Readiness for Surgery (Minutes)||within 60 minutes after injection of the local anesthetic||||minutes||95% Confidence Interval|Mean
1363500|NCT01643616|Primary|Success Rate Without Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division"|within 30-60 minutes after injection of the local anesthetic|In the NS group two investigators were necessary in order to realize the blinded study protocol. For personnel reasons this was not possible in every case and led to deviations from the randomization protocol for seven patients in each group. These patients were excluded from the analysis.|||participants|||Number
1363501|NCT01643525|Secondary|Nautilus NeuroWaveTM Recording in MRI Normal Population (no Cerebrovascular Disease Per MRI)||At study completion- approximately 8 months|||||||
1363502|NCT01643525|Secondary|Incidence of Device Related Adverse Events||At study completion- approximately 8 months|||||||
1363503|NCT01643525|Secondary|Determine the Location to Left, Right, Deep, and/or Back of the Cranium||At study completion- approximately 8 months|||||||
1363504|NCT01643525|Primary|Sensitivity, Specificity and Predictive Values of the Jan Medical DC1 System in Detecting Ischemia Within 12 Hours of Known Stroke Onset in Comparison to Follow up CT and MRI.||At study completion- approximately 8 months|Terminated study, data incomplete. Data not analyzed.||||||
1363505|NCT01643213|Primary|Subject's Treatment Preference|Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline|30 minutes after activation of stimulation||||participants|||Number
1363506|NCT01643044|Primary|Alcohol Use|Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.|self-reported use during 90 days prior to delivery of their baby||||participants|||Number
1363560|NCT01642407|Other Pre-specified|Apparent Oral Clearance (CL/F) of Sildenafil|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
1363507|NCT01642914|Primary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
1363508|NCT01642914|Secondary|9/12 Week Mild Straining and Diarrhea-free Responder|"A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
1363509|NCT01642914|Secondary|Change From Baseline in Severity of Straining at Week 12|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is “not at all” and a value of 5 is “an extreme amount.”~A patient’s straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
1363510|NCT01642914|Secondary|Change From Baseline in 12-week Severity of Straining|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is “not at all” and a value of 5 is “an extreme amount.” A patient’s straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
1363511|NCT01642914|Secondary|Change From Baseline in Stool Consistency at Week 12|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]~A patient’s BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
1363512|NCT01642914|Secondary|Change From Baseline in 12-week Stool Consistency|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]~A patient’s BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
1363917|NCT01639729|Primary|Cmax|maximum plasma concentration|24 hours||||pg/mL||Standard Deviation|Mean
1363513|NCT01642914|Secondary|Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product|"Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time).~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||Hours||95% Confidence Interval|Median
1363514|NCT01642914|Secondary|SBM Within 24 Hours After the First Dose of Investigational Product|"The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|24 hours from first dose of investigational product (Day 1)|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
1363515|NCT01642914|Secondary|Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM)|"A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||Days per week||Standard Deviation|Mean
1363516|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 12|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
1363517|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 8|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
1363518|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 4|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
1363534|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment|Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.|||percent of days||Standard Deviation|Mean
1363519|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 1|"A patient’s baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
1363520|NCT01642914|Secondary|Change From Baseline in 12-Week SBM Frequency Rate|"A patient’s Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
1363521|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 12|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
1363522|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 8|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
1363523|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 4.|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
1363524|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 1.|"A patient’s CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
1363533|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24|The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|Weeks 8 to 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.|||percent of days||Standard Deviation|Mean
1403424|NCT01234675|Primary|Number of Awakenings After Sleep Onset||Overnight PSG week 5/ upto week 12; milnacipran treatment||||Number of Awakenings||Standard Error|Mean
1363525|NCT01642914|Secondary|Change From Baseline in 12-week CSBM Frequency Rate|"A patient’s 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient’s 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
1363526|NCT01642914|Secondary|6/12 Week Abdominal Bloating 30% Responder|A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient’s improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
1363527|NCT01642914|Secondary|Percent Change From Baseline in Abdominal Bloating at Week 12|Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12.|Baseline and Week 12|Reported outcome data is based on the 483 patient Intent-to-Treat Population. The distribution of each of the linaclotide groups was compared, in a pair-wise manner, to the placebo group using the two-sample Kolmogorov–Smirnov test.|||percentage change in abdominal bloating||Standard Deviation|Mean
1363528|NCT01642914|Secondary|Percent Change From Baseline in 12-week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||percentage change of NRS score||Standard Deviation|Mean
1363529|NCT01642914|Secondary|Change From Baseline in 12-Week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
1363530|NCT01642914|Secondary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
1363531|NCT01642732|Secondary|Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus|Analysis of pairs of markers will be explored looking for large positive or negative correlations to indicate marker areas for further research.|Prior to treatment and at 14 days|One patient was enrolled and withdrew from the study prior to treatment. The objective was not analyzed.||||||
1363532|NCT01642732|Primary|Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation||64 months after beginning everolimus|One patient was enrolled and withdrew from the study prior to treatment. The primary objective was not analyzed.||||||
1363575|NCT01642407|Secondary|Change From Baseline in Pulmonary Artery Systolic and Diastolic Pressure at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||mmHg||Standard Deviation|Mean
1363535|NCT01642615|Secondary|Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24|Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.|From Week 8 to Week 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.|||percentage of participants||95% Confidence Interval|Number
1363536|NCT01642615|Secondary|Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8|Healing of EE was assessed by endoscopy.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1363537|NCT01642615|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|From Week 8 to Week 24|Safety Analysis Set included all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.|||percentage of participants|||Number
1363538|NCT01642615|Primary|Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|8 weeks|Safety analysis set includes all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks.|||percentage of participants|||Number
1363539|NCT01642602|Secondary|The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment|Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.|4 weeks|Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the efficacy variable.|||Percentage of days||Full Range|Median
1363540|NCT01642602|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period|A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.|4 weeks|Safety analysis set: All participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1363541|NCT01642589|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine|"Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set|||Participants|||Number
1363542|NCT01642589|Secondary|Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and 28 days post-vaccination|Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
1363543|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set|||Percentage of participants|||Number
1363544|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set|||Percentage of participants|||Number
1363545|NCT01642589|Primary|Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine|"Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).~Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level."|28 Days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set|||Percentage of participants|||Number
1363546|NCT01642485|Secondary|The QTcF Profile of Oral Moxifloxacin (400 mg) in Healthy Japanese Versus Caucasian Subjects||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||ms||95% Confidence Interval|Mean
1363547|NCT01642485|Secondary|Insulin, Glucose and C-Peptide Effects on the QT/QTc Interval|The effect on QTc was investigated using linear mixed effect models with placebo corrected QTcF (change from average baseline) as a dependent variable and insulin, glucose and C-peptide (placebo corrected) as covariates for the data obtained under the euglycaemic clamp as well as for all data obtained under the clamp and the two types of breakfast.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||msec||95% Confidence Interval|Median
1363548|NCT01642485|Secondary|Moxifloxacin 400 mg (Single Dose) Compared to Placebo on the Mean QT/QTc Interval.|"Moxifloxacin 400mg Fasted group is reporting the maximum change in QT/QTc interval from placebo treatment."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||ms||90% Confidence Interval|Mean
1363549|NCT01642485|Secondary|The Food Effects (Calorie Reduced FDA Breakfast and Carbohydrate Rich Continental Style) on QTcF|"Scott et al (2002) demonstrated an increase in the heart rate of 10bpm in some healthy subjects following ingestion of a carbohydrate meal. There was significant correlation between the resultant hyperinsulinaemia and an increase in skeletal muscle blood flow, and sympathetic activity, with a reduction in vascular resistance.~If postprandial insulinaemia is a significant influence on the QT interval, then carbohydrate rich meals would be expected to show greater effect. Therefore, to explore this on two separate days of the study subjects will be given one of two different types of breakfast:~A high carbohydrate content breakfast, (>70% carbohydrate)~A reduced calorie FDA standard breakfast, (58% fat, low carbohydrate content) to determine effect on QT interval."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||ms||90% Confidence Interval|Mean
1363550|NCT01642485|Primary|The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin|The primary baseline corrections were calculated using averaged QTc baseline values (the mean of all median readings recorded for each time-point on the baseline Day -1). This single value (QTcbaselineAV) was used to calculate ΔQTc for each study period.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|Since the baseline was used as a covariate in the analysis, using the standard deviation of the change from baseline, in the simple sample size formula is justified. Assuming a standard deviation of 7 msec for the single differences, sample sizes for the sum can therefore work with a standard deviation of 6.5 msec.|||ms||90% Confidence Interval|Mean
1363551|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 16|Tricuspid annular plane systolic excursion is a parameter depicting global right ventricular function. Change from baseline in TAPSE (in cm) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||cm||Standard Deviation|Mean
1363552|NCT01642407|Other Pre-specified|Number of Participants With Pericardial Effusion|Pericardial effusion is the presence of an abnormal amount of fluid in the pericardial cavity, as determined by echocardiography.|Baseline up to Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1363553|NCT01642407|Other Pre-specified|Change From Baseline in Pulmonary Regurgitation - Pressure Gradient (PR-PG) End-Diastole at Week 16|Pulmonary regurgitation (PR) or insufficiency is a valvular heart disease characterized by an incomplete closure of the pulmonary valve leading to a diastolic reflux into the right ventricle. Change from baseline in PR-PG end-diastole (in mmHg) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||mmHg||Standard Deviation|Mean
1363554|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Regurgitation - Pressure Gradient (TR-PG) Peak at Week 16|Tricuspid regurgitation (insufficiency) is the failure of the tricuspid valve to close properly during systole, leading to the leaking of blood from the right ventricle into the right atrium. Change from baseline in TR-PG peak (in mmHg) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||mmHg||Standard Deviation|Mean
1363555|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Valve Annulus Size at Week 16|The tricuspid valve lies between the right atrium and the right ventricle and is placed in a more apical position than the mitral valve. The annulus separates the right atrium from the right ventricle. Change from baseline in tricuspid valve annulus size (in cm) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||cm||Standard Deviation|Mean
1363556|NCT01642407|Other Pre-specified|Change From Baseline in Right Ventricular Size at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||centimeter (cm)||Standard Deviation|Mean
1363557|NCT01642407|Other Pre-specified|Change From Baseline in Right Ventricular Tei Index at Week 16|The right ventricular Tei Index is an index of myocardial performance. It is defined as the sum of isovolumic contraction time and isovolumic relaxation time divided by the ejection time.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||ratio||Standard Deviation|Mean
1363558|NCT01642407|Other Pre-specified|Change From Baseline in Ratio of Acceleration Time to Ejection Time (AcT/ET) at Week 16|Acceleration time and ejection time are quantitative Doppler parameters and ratio of acceleration time to ejection time is a useful tool to evaluate the severity of aortic stenosis.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||ratio||Standard Deviation|Mean
1363559|NCT01642407|Other Pre-specified|Apparent Volume of Distribution (Vz/F) of Sildenafil|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest. Here,'N' signifies those participants who were evaluable for this measure.|||liter||Full Range|Median
1363561|NCT01642407|Other Pre-specified|Terminal Half Life (t1/2) of Sildenafil and UK-103,320|Terminal half-life is the time measured for the plasma concentration to decrease by one half of its original concentration. UK-103,320 was a main metabolite of sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||hour||Full Range|Median
1363562|NCT01642407|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||hour||Full Range|Median
1363563|NCT01642407|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||nanogram*hour per millimeter||Geometric Coefficient of Variation|Geometric Mean
1363564|NCT01642407|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|Pharmacokinetic (PK) parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1363565|NCT01642407|Secondary|Change From Baseline in Arterial Oxygen Saturation (SaO2) at Week 16|SaO2 is the percentage of arterial oxygen (amount of oxygen bound to hemoglobin in arterial blood). Change from baseline in percentage of arterial oxygen was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||percentage of arterial oxygen||Standard Deviation|Mean
1363566|NCT01642407|Secondary|Change From Baseline in Mixed Venous Oxygen Saturation (SvO2) at Week 16|SvO2 is the percentage of mixed venous oxygen (amount of oxygen bound to hemoglobin in venous blood). Change from baseline in percentage of mixed venous oxygen was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||percentage of mixed venous oxygen||Standard Deviation|Mean
1363567|NCT01642407|Secondary|Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Week 16|SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||Wood units*meter^2||Standard Deviation|Mean
1363568|NCT01642407|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at Week 16|The resistance to blood flow through the systemic circulation is known as SVR. This can be used in measuring blood pressure, blood flow and cardiac function and measured in terms of Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||Wood units||Standard Deviation|Mean
1363569|NCT01642407|Secondary|Change From Baseline in Cardiac Index (CI) at Week 16|Cardiac index is a hemodynamic parameter that relates the cardiac output from left ventricle in one minute to BSA, thus relating heart performance to the size of the individual. CI was calculated as cardiac output in systemic circulation divided by BSA.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||liter per minute per meter square||Standard Deviation|Mean
1363570|NCT01642407|Secondary|Change From Baseline in Cardiac Output (CO) at Week 16|Cardiac output is simply the amount of blood pumped by the heart per minute.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||liter per minute||Standard Deviation|Mean
1363571|NCT01642407|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 16|PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||mmHg||Standard Deviation|Mean
1363572|NCT01642407|Secondary|Change From Baseline in Right Atrial Pressure (RAP) at Week 16|RAP is the blood pressure in the right atrium of the heart. It reflects the amount of blood returning to the heart and the ability of the heart to pump the blood into the arterial system. RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||mmHg||Standard Deviation|Mean
1363573|NCT01642407|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16|The resistance to blood flow through the pulmonary circulation is known as PVR. It is largely influenced by the caliber of the pulmonary arteries and capillaries and was measured in terms of Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||Wood units||Standard Deviation|Mean
1363574|NCT01642407|Secondary|Change From Baseline in Systemic Artery Systolic and Diastolic Pressure at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||mmHg||Standard Deviation|Mean
1363918|NCT01639729|Primary|AUC (0 - Inf)|total amount of sufentanil absorbed|24 hours|A The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: AUC 0-inf (n=18).|||h.pg/mL||Standard Deviation|Mean
1363577|NCT01642407|Secondary|Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for clinically significant abnormality in ECG parameters: Maximum corrected QT interval (QTc) from 450 millisecond (msec) to less than (<) 480 msec, Maximum QTcB interval (Bazett’s Correction) from 450 msec to <480 msec, Maximum QTcF interval (Fredericia’s Correction) from 450 msec to <480 msec, maximum QTc interval increase from baseline of 30 msec to <60 msec and >=60 msec.|Baseline up to Week 16|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1363578|NCT01642407|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormality criteria: Hematology (hemoglobin, hematocrit, red blood cell count [less than {<}]0.8*lower limit of normal [LLN]; platelets <0.5*LLN, greater than [>]1.75*upper limit of normal [ULN], white blood cells <0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN, eosinophils, basophils, monocytes >1.2*ULN); liver function (total and direct bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, total protein, albumin <0.8*LLN, >1.2*ULN); renal (creatinine, blood urea nitrogen >1.3*ULN); electrolytes (sodium <0.95*LLN, >1.05*ULN, potassium, chloride <0.9*LLN, >1.1*ULN; other (glucose <0.6*LLN or >1.5*ULN ); urinalysis (dipstick) urine glucose, urine protein, urine blood/Hemoglobin, [greater than or equal to {>=}1].|Baseline up to Week 16|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1363579|NCT01642407|Secondary|Change From Baseline in Heart Rate at Week 4, 8 and 16||Baseline, Week 4, 8, 16|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||beats per minute (bpm)||Standard Deviation|Mean
1363580|NCT01642407|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 8 and 16|BP measurement is recorded as 1) Systolic blood pressure when heart is contracting and it is the maximum arterial pressure during contraction of left ventricle. 2) Diastolic BP when heart is relaxing and it is the minimum arterial pressure during relaxation and dilation of ventricles.|Baseline, Week 4, 8, 16|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||mmHg||Standard Deviation|Mean
1363581|NCT01642407|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 28 days after last dose of study drug (up to 20 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1363582|NCT01642407|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose of study drug (up to 20 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1363583|NCT01642407|Secondary|Change From Baseline in N-terminal Pro Brain Natriuretic Peptide (NT Pro-BNP) at Week 52|NT pro-BNP is a cardiac marker, having the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 52|||||||
1363584|NCT01642407|Secondary|Change From Baseline in Brain Natriuretic Peptide (BNP) at Week 52|BNP is produced by ventricular cardiomyocytes. It causes reduction in preload and blood pressure by vasodilatation.|Baseline, Week 52|||||||
1363585|NCT01642407|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 28, 40 and 52|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class.|Baseline, Week 28, 40, 52|||||||
1363586|NCT01642407|Primary|Change From Baseline in N-terminal Pro Brain Natriuretic Peptide (NT Pro-BNP) at Week 16|NT pro-BNP is a cardiac marker, having the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||picogram per milliliter||Standard Deviation|Mean
1363587|NCT01642407|Primary|Change From Baseline in Brain Natriuretic Peptide (BNP) at Week 16|BNP is produced by ventricular cardiomyocytes. It causes reduction in preload and blood pressure by vasodilatation.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||picogram per milliliter||Standard Deviation|Mean
1363588|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 16|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here,'N' signifies those participants who were evaluable for this measure.|||participants|||Number
1363589|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 8|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported.|Baseline, Week 8|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here,'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1363590|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 4|WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported.|Baseline, Week 4|Efficacy analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1363591|NCT01642407|Primary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 16|It was a hemodynamic parameter and measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1363592|NCT01642407|Primary|Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Week 16|PVRI equals pulmonary vascular resistance (PVR) times body surface area (BSA) (PVRI = PVR*BSA). PVR is the resistance to blood flow through the pulmonary circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||Wood units*meter^2||Standard Deviation|Mean
1363593|NCT01642277|Secondary|Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire|"The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = Not at all to 4 = Quite a bit. From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity)."|12 weeks|Participants who received solifenacin were asked to complete the PFDI questionnaire at 12 weeks in order to assess certain bowel, bladder, and pelvic symptoms.|||units on a scale||Inter-Quartile Range|Median
1363594|NCT01642277|Secondary|Assessment of Overactive Bladder Questionnaire (OABQ)|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity).|End of study (Week 12)|Participants who received solifenacin were asked to complete the OABQ at 12 weeks in order to assess overactive bladder symptoms.|||units on a scale||Inter-Quartile Range|Median
1363595|NCT01642277|Primary|Bacterial Genomic Sequencing|Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.|12 weeks|This was a completer analysis comprising participants who completed 12 weeks of treatment (n = 50).|||participants|||Number
1363596|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|24-hours post-treatment||||seconds||95% Confidence Interval|Mean
1363597|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|1 hr post-treatment||||seconds||95% Confidence Interval|Mean
1363598|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|Pre-treatment baseline||||seconds||95% Confidence Interval|Mean
1363599|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|24-hours post-treatment||||percent inhibition||95% Confidence Interval|Mean
1363600|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|1 hr post-treatment||||percent inhibition||95% Confidence Interval|Mean
1363601|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|Pre-treatment baseline||||percent inhibition||95% Confidence Interval|Number
1363602|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 24 hrs post treatment||||percent change||95% Confidence Interval|Mean
1363604|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 4 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 4 is rated as None, I had no pain (score=0), mild pain (score=1), moderate pain (score=2), severe pain (score=3), or very severe pain (score=4); 4 is the worst pain. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
1363605|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 1 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 1 is rated as Yes (score=0) or No (score=1); higher values indicate a worse outcome. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
1363606|NCT01642212|Secondary|Percent of Days That Participants Reported That They Avoided Solid Food During The Baseline And Treatment Periods|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Values were calculated for all the days that Question 1 was answered from 14 days prior to baseline visit up to the final treatment period evaluation.|From 14 days prior to the baseline visit to the final treatment period evaluation|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percentage of days||Inter-Quartile Range|Mean
1363607|NCT01642212|Secondary|Percent of Participants Who Were Symptom Responders on The DSQ+Pain Scale at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Question 1 (did you eat solid food) and Question 2 (did food pass slowly or get stuck). If the answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Question 3 (did you have to do anything to make the food go down or get relief) and Question 4 (extent to which the participant experienced pain while swallowing).The DSQ+pain response was defined as a >/= 30% and >/= 50% reduction from baseline in the combined score from Questions 2, 3, and 4. The 2-week DSQ+pain score was calculated by adding points from Questions 2, 3, and 4 and then taking the average of the available scores over each 2-week interval.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363608|NCT01642212|Secondary|Percent of Participants With New Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363634|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
1363635|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
1363609|NCT01642212|Secondary|Percent of Participants Without Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363610|NCT01642212|Secondary|Percent of Participants With Worsened Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363611|NCT01642212|Secondary|Percent of Participants With No Change in Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363612|NCT01642212|Secondary|Percent of Participants With Improved Symptoms on The Eosinophilic Esophagitis (EoE) Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom (‘Yes’ to ‘No’); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom (‘No’ to ‘Yes’).|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363613|NCT01642212|Secondary|Distribution of Responses For The Patient Global Impression of Change (PGIC) Survey at The Final Treatment Evaluation|Participants evaluated the change in their dysphasia (food passing slowly/difficulty swallowing) since the start of the study (screening) by choosing 1 of 7 responses on the PGIC survey: much worse (-3), worse (-2), a little worse (-1), no change (0), a little better (1), better (2), or much better (3). The values reported are the percent of participants who chose that response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363614|NCT01642212|Secondary|Change From Baseline in The Physician’s Global Assessment (PGA) of Disease Activity at The Final Treatment Period Evaluation|The physician Investigator (or qualified physician’s assistant or nurse practitioner) completed the PGA to provide the global assessment of eosinophilic esophagitis (EoE) disease activity using a 0 to 100 mm visual analog scale (VAS) scale. The VAS is a 100 mm horizontal line on which the right extreme (100) is labeled “worst possible disease activity” and the left extreme (0) is labeled “no disease activity”. The PGA raters were instructed to consider the line for the VAS a continuum with their own medical opinion or judgment of extremes on either end and to draw a vertical line at a point that best approximates the participant's current level of EoE disease activity. A negative change from baseline indicates that disease activity decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
1363636|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery|It was the baseline mean blood flow velocity in middle cerebral artery.|before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
1363615|NCT01642212|Secondary|Change From Baseline in The Peak Eosinophil Count at Each Available Esophageal Level at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. Baseline was defined as the score at screening. A negative change from baseline indicates that eosinophil count decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||eosinophils/HPF||Standard Error|Least Squares Mean
1363616|NCT01642212|Secondary|Change From Baseline in The Total Endoscopy Score at The Final Treatment Period Evaluation|The gross endoscopic appearance of the esophageal surface was evaluated by a blinded study center physician. Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 major categories, including exudates or plaques, fixed esophageal rings, edema, furrows, and strictures. The endoscopy score was the sum of the scores for the 5 major categories – grade 0-1 for strictures; grade 0-2 for exudates or plaques, edema, and furrows; and grade 0-3 for fixed esophageal rings for the proximal and distal locations. The maximum endoscopy score was 10 points for each location (proximal and distal), and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points). Baseline was defined as the endoscopy score at screening. A negative change from baseline indicates that appearance improved.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
1363617|NCT01642212|Secondary|Change From Baseline in The Histopathologic Epithelial Features Combined Total Score at The Final Treatment Period Evaluation|Each esophageal biopsy specimen was evaluated microscopically by an independent, central pathologist for signs of epithelial inflammation and lamina propria fibrosis. Histopathologic epithelial features of each available esophageal level biopsy consisting of basal layer hyperplasia, eosinophil peak, dilated intercellular spaces, eosinophil microabcesses, surface layering, surface alteration, and apoptotic epithelial cells were scored and summed. Histopathology data were collected in a blinded fashion. Histopathology epithelial features were scored for both grade and stage. Each feature had a possible score of 0-3 for grade as well as stage. Thus each of the 3 levels had a possible score of 21, and a possible total grade or stage score of 63 for a maximum combined score of 126. The grade and stage score of the lamina propria was not included because the biopsy material was not available. A negative change from baseline indicates that epithelial inflammation decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
1363618|NCT01642212|Secondary|Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation|Overall response was defined as a reduction in the 2-week DSQ score of >/= 30% and >/= 50% from baseline to the final treatment period evaluation and a peak eosinophil count of </= 6/high power field (light microscopy) (HPF) across all available esophageal levels at the final treatment period evaluation. An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363619|NCT01642212|Secondary|Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363620|NCT01642212|Secondary|Percent of Participants With a Peak Eosinophil Count </= 15/High Power Field (Light Microscopy) (HPF) And </= 1/HPF at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. The values reported are for participants with histologic response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363637|NCT01642082|Secondary|Adverse Events (Primary Serious and All Other AEs)|The frequencies of the maximum grade of any acute adverse event, regardless of attribution are reported during treatment and up to 30 days after stopping the study treatment are reported.|Every cycle of study treatment and after treatment for a maximum of 5 years from study entry|Eligible and treated patients|||Participants|||Count of Participants
1363621|NCT01642212|Secondary|Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation|A cumulative distribution function curve was constructed to illustrate the cumulative proportion of participants (x-axis) vs. the change in the DSQ score from baseline to the final treatment evaluation (y-axis). The 50th percentile is participants with a DSQ score that is in the middle of the distribution of all scores. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale|||Number
1363622|NCT01642212|Secondary|Change From Baseline in The DSQ Score Over Time|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8 and 12|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
1363623|NCT01642212|Primary|Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
1363624|NCT01642212|Primary|Percent of Participants Who Were Histologic Responders|Histologic response was defined as a peak eosinophil count </= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The modified Intent-to-Treat (MITT) Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
1363625|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
1363626|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
1363627|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
1363628|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
1363629|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||at extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
1363630|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
1363631|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
1363632|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
1376633|NCT01490931|Primary|Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||4 Hours post-dose||||millimeters||Standard Error|Mean
1363639|NCT01642082|Secondary|Duration of Progression-free Survival|Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients.|||months||90% Confidence Interval|Median
1363640|NCT01642082|Secondary|Progression-free Survival at 6 Months|"Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.~Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for progression-free survival at 6 months."|: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1363641|NCT01642082|Primary|Treatment and Progression-free Survival at 6 Months|"Treatment and Progression-free Survival is defined as the duration alive from study entry until progression is documented, death or non-protocol treatment is initiated; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions’ longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.~Non-protocol treatment initiation prior to disease progression and prior to 6 months from study entry was counted as an event for treatment and progression-free survival at 6 months. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for treatment and progression-free survival at 6 months."|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|All eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1363642|NCT01642082|Primary|Response|Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be < 10 mm in short axis; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.|All eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1363643|NCT01642004|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||participants|||Number
1363644|NCT01642004|Secondary|Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||months||95% Confidence Interval|Median
1363645|NCT01642004|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1363646|NCT01642004|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||months||95% Confidence Interval|Median
1363647|NCT01642004|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1363648|NCT01642004|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CI for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)|||months||95% Confidence Interval|Median
1363649|NCT01642004|Secondary|Progression-Free Survival (PFS) at Primary Endpoint|PFS rate was defined as the probability that participants will experience no disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy|Randomization to 12 months post-randomization, up to November 2014|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)|||percent probability of PFS||95% Confidence Interval|Number
1363650|NCT01642004|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.~Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)|||months||95% Confidence Interval|Median
1363651|NCT01642004|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)|||months||Full Range|Median
1363652|NCT01642004|Primary|Overall Survival (OS) Rate in All Randomized Participants|The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 18 months post-randomization, up to June 2015|All randomized participants|||percent probability of OS||95% Confidence Interval|Number
1363653|NCT01642004|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||months||95% Confidence Interval|Median
1363654|NCT01642004|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1363655|NCT01642004|Other Pre-specified|Overall Survival (OS) Time in Months for All Randomized Participants at Updated Survival Follow-up|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred 7.4 months after Primary Endpoint was reached, representing a minimum OS follow-up time of 18.0 months.|Randomization until July 2015, approximately 33 months|All randomized participants|||months||95% Confidence Interval|Median
1363656|NCT01641991|Secondary|TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. To determine the group peak GMT, the highest titer assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of each subjects' peak titers was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||titer||95% Confidence Interval|Geometric Mean
1363657|NCT01641991|Secondary|Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. A participant met the threshold of a 4-fold rise in anti-PA IgG antibody concentration if the post vaccination concentration was an increase by 4-fold or more from the baseline (Day 0) concentration.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
1363658|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination and recorded oral temperatures.|||participants|||Number
1363659|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363660|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363661|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363662|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination.|||participants|||Number
1363663|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363664|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363665|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363666|NCT01641991|Secondary|Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. To determine the group peak GMC, the highest antibody concentration assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of subjects' peak concentrations was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||µg/mL||95% Confidence Interval|Geometric Mean
1363667|NCT01641991|Secondary|TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (0.03) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||titer||95% Confidence Interval|Geometric Mean
1363668|NCT01641991|Secondary|Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)|Participants were given a ruler with the memory aid to measure the occurrence of edema (swelling) and erythema (redness) daily for at least 8 days after each vaccination. Participants are counted in this outcome measure if they had measurements of greater than 120 mm in the 8-day period after at least one vaccination, first separately for edema and erythema, and in the last category, edema and/or erythema, if they had either or both reactions of greater than 120 mm.|Days 0-7 after each vaccination|The analysis population includes all participants who were vaccinated per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363669|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month booster vaccination.|||participants|||Number
1363692|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2|Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015.|C1D1; C4D1|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.|||mcg/mL||Standard Deviation|Mean
1363670|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363671|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363672|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
1363673|NCT01641991|Secondary|Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (4.64) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||µg/mL||95% Confidence Interval|Geometric Mean
1363674|NCT01641991|Primary|Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.|Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
1363675|NCT01641978|Secondary|Years of Professional Experience for Nurses in Critical Care|Influence of professional experience in the evaluation of neurological patients|1 year|Nurses with a minimum experience of three years in intensive care|||years||Inter-Quartile Range|Median
1363676|NCT01641978|Secondary|Severity in Glasgow Coma Scale (GCS) by Groups.|"The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).~Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).~It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness."|1 year|Neurological and/or neurosurgical patients in ICU|||percentage of correlation||95% Confidence Interval|Number
1363677|NCT01641978|Primary|Interobserver Correlation|interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) 95%|1 year||||percentage of correlation||95% Confidence Interval|Number
1363678|NCT01641952|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 20|HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA). It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ the patient must have a domain score for at least 6 of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and Week 20|Intent to treat population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated to the screening exam, and have completed the baseline visit and at least one further assessment. Here, number of participant analysed is the participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1363679|NCT01641952|Primary|Number of Participants With Adverse Events (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 39 months|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
1363680|NCT01641952|Primary|Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline (CFB) indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||participants|||Number
1363681|NCT01641952|Primary|Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1363682|NCT01641952|Primary|Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1363683|NCT01641952|Primary|Percentage of Participants With EULAR Response|The DAS28 score is a measure of the participant’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1363693|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1|Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.|||nanogram per milliliter (mcg/mL)||Standard Deviation|Mean
1363684|NCT01641952|Primary|Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1363685|NCT01641952|Primary|Mean DAS28-ESR Score at Visit 4 (Week 20)|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1363686|NCT01641952|Primary|Change From Baseline in DAS28-ESR at Week 20|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity [measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity]. DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline and Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
1363687|NCT01641952|Primary|Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria|The DAS28 score is a measure of the participant’s disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1363688|NCT01641939|Secondary|Systemic Clearance (CL) - Stage 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||mL/day/kg||Standard Deviation|Mean
1363689|NCT01641939|Secondary|Volume of Distribution at Steady State (Vss) - Stage 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
1363690|NCT01641939|Secondary|Plasma Decay Half-Life (t1/2) - Stage 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||days||Standard Deviation|Mean
1363691|NCT01641939|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1|AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||day*mcg/mL||Standard Deviation|Mean
1364259|NCT01636453|Primary|Number of Participants With Raymond Class I Complete Obliteration at 12 Months|Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).|At 12 months post-implant||||Participants|||Count of Participants
1363694|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1|Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization.|Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1363695|NCT01641939|Secondary|Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.|||months||95% Confidence Interval|Median
1363696|NCT01641939|Secondary|Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 ‘Not at all’ to 4 ‘Very much’). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.|||percentage of participants|||Number
1363697|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3|The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 ‘Not at all’ to 4 ‘Very much’; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.|||percentage of participants||95% Confidence Interval|Number
1363698|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3|The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 ‘Not at all’ to 4 ‘Very much’; with the exception of the QoL/health status scale which uses a 7-point scale (1 ‘very poor’ to 7 ‘Excellent’). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.|||percentage of participants||95% Confidence Interval|Number
1363699|NCT01641939|Secondary|Duration of Objective Response (DOR) - Phase 3|DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1364270|NCT01636206|Primary|Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year||Day 0 to Day 360|Safety population included all randomized participants who received at least 1 dose of investigational product.|||participants|||Number
1363700|NCT01641939|Secondary|Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with measurable disease were included in analysis of this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1363701|NCT01641939|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.|||months||95% Confidence Interval|Median
1363702|NCT01641939|Secondary|Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.|||percentage participants|||Number
1363703|NCT01641939|Primary|Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive.|Date of randomization until death (up to 1 year)|Analysis population included all participants that had been enrolled in phase 2 (stage 1) up to a clinical cut-off date of 10 August 2013; participants grouped according to the therapy they were randomized to receive. Here, N (number of participants analyzed)=number of evaluable participants during phase 2 up to 10 August 2013.|||weeks||95% Confidence Interval|Median
1363704|NCT01641939|Primary|Overall Survival (OS)- Phase 3|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until death (up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.|||months||95% Confidence Interval|Median
1363705|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. HBV DNA levels in blood were measured by the Roche COBAS TaqMan HBV-(High Pure System Assay). The percentage of HBeAg(+) participants with the combined response of achieving both HBeAg conversion and HBV DNA levels <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.|||percentage of participants|||Number
1363706|NCT01641926|Secondary|Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment|ALT normalization is a desired goal of HBV treatment, which is defined as having abnormal ALT levels at baseline and subsequently normal ALT levels after receiving treatment, where normal is defined as ≤ 1x the upper limit of normal (ULN). The percentage of HBeAg(+) and HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) and HBeAg(-) participants who received ≥1 dose of study medication.|||percentage of participants|||Number
1363707|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(+)participants. The percentage of HBeAg(+) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.|||percentage of participants|||Number
1363708|NCT01641926|Primary|Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(-) participants who received ≥1 dose of study medication. HBeAg(+) participants were not included in this analysis.|||percentage of participants|||Number
1363709|NCT01641926|Primary|Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment|Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not analyzed for HBeAg seroconversion.|||percentage of participants|||Number
1363710|NCT01641900|Secondary|Motor Procedural Memory Performance|Overnight performance improvement on the finger tapping motor sequence task (MST).The MST involves pressing four numerically labeled keys on a standard keyboard with the fingers of the left hand, repeating a 5 digit sequence as quickly and accurately as possible for 12 trials at 30 seconds each separated by 30 sec rest periods. Different sequences were employed for the Placebo and Drug visits in a counter-balanced order. MST performance is measured as the number of correctly typed sequences in each trial. The primary outcome measure is overnight improvement calculated as the percent increase in average of correct sequences from the last three training trials to the average of first three test trials. Since the outcome measure is calculated as percent improvement from training to test for each participant, there is no highest or lowest possible score.|Experimental Night (Night 2)||||percentage of improvement on MST perform||Standard Deviation|Mean
1363711|NCT01641900|Primary|Sleep Spindle Density|This measure is averaged for Baseline and Experimental nights. Sleep spindle density (number/minute) for non-Rapid Eye Movement Stage 2 sleep (N2) detected at channel Cz based on polysomnographic recordings.|Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)||||Sleep spindle density (number/minutes)||Standard Deviation|Mean
1363712|NCT01641861|Secondary|Time Use for Caries Removal|The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.|Immediately while treatment||||seconds||Inter-Quartile Range|Median
1363713|NCT01641861|Secondary|Levels of Pain and Discomfort|The participants were assessed for the levels of pain and discomfort using the facial visual analogue scale (VAS). The score was recorded in ruler scale from 0-100 millimeters, 0 = no pain and 100 = extreme pain) before treatment with the child sitting on the dental chair and after treatment (completion of carious tissue removal). The difference in the VAS scores before and after treatment was calculated and compared between the two comparison groups.|immediately after treatment||||Pain score from 0-100||Inter-Quartile Range|Median
1363714|NCT01641861|Secondary|Number of Participants With Complete Caries Removal|The efficacy of caries removal was evaluated by the visual and tactile criteria. The completeness of caries removal was judged on the basis of clinical criteria involving the inspection of the tooth surfaces using a good light source, dental mirror and explorer. A blunt explorer was used to detect surface roughness by gently stroking across the dentine surfaces and to evaluate the dentine hardness. Complete caries removal was achieved if as remove soft and infected dentine until felt hard and leathery consistency of the dentine surfaces. The tactile criteria include the smooth passage of the blunt explorer and absence of a catch or a “tug-back” sensation.|immediately after treatment||||participants|||Number
1363715|NCT01641861|Secondary|Incidence of Secondary Caries|The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.|two years||||participants|||Number
1363716|NCT01641861|Primary|Number of Participants With Treatment Failure|The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).|two years||||participants|||Number
1363717|NCT01641835|Primary|Bruch's Membrane Opening - Minimum Rim Area, Global||3 months||||microns^2||Standard Deviation|Mean
1363718|NCT01641835|Primary|Primary Endpoints|The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.|3 months||||microns||Standard Deviation|Mean
1363719|NCT01641822|Secondary|Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1363720|NCT01641822|Secondary|Rate of Hospitalizations for a Respiratory Event|The rate of hospitalizations for a respiratory event per participant year was calculated using negative binomial regression analysis.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set|||hospitalizations per participant year|||Number
1363721|NCT01641822|Secondary|Time to First Protocol-defined Pulmonary Exacerbation|The time to first protocol-defined pulmonary exacerbation was calculated using the Kaplan-Meier method.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set|||days||95% Confidence Interval|Median
1363722|NCT01641822|Secondary|Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs||Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set|||percentage of participants|||Number
1364260|NCT01636414|Primary|Change in Hemoglobin Level|Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.|Post-operative on day 2 (first day after surgery)||||g/dl||Inter-Quartile Range|Median
1363723|NCT01641822|Secondary|Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex and body composition. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.|||percentage of FEV1 % predicted||Standard Error|Mean
1363724|NCT01641822|Primary|Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24|PDEs were characterized by a change or worsening from baseline of 1 or more documented signs or symptoms (decreased exercise tolerance, increased cough, increased sputum or chest congestion, decreased appetite, or other signs or symptoms) associated with the use of non-study IV or inhaled antibiotics and be verified by a blinded independent adjudication committee.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|Intent-to-Treat (ITT) Analysis Set: all randomized participants|||PDEs per participant year|||Number
1363725|NCT01641692|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Day 7 to Day 14 of Each Treatment Period|The mean number of puffs per day of rescue salbutamol at Baseline (i.e. run-in or washout data) and on-treatment were recorded. Total puffs was calculated as (Number of Puffs + (2 x number of Nebules)). Only the 7 days proceeding each treatment period were included in the Baseline calculations. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Number of puffs||Standard Deviation|Mean
1363726|NCT01641692|Secondary|Change From Baseline in Mean Morning (AM) and Evening (PM) Pre-treatment Peak Expiratory Flow (PEF) Over Day 7 to Day 14 of Each Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 7 to 14 was analyzed. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; Baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Liters per minute||Standard Deviation|Mean
1363727|NCT01641692|Secondary|Change in Baseline in Serial FEV1 Over 0-24 Hours After the Morning Dose on Day 14 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 was measured at 5, 15, 30 minutes (min), 1, 3, 6, 9, 12, 16, 20, 23 and 24 hours (h) post-dose. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis was preformed using a repeated measures model with terms for period, treatment, time, mean Baseline, period Baseline, and time by mean Baseline, time by period Baseline, and time by treatment interactions.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Liters||Standard Error|Least Squares Mean
1363728|NCT01641692|Secondary|Change From Baseline (BL) in the Weighted Mean (WM) 0-24 Hour FEV1 Obtained Post-AM Dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from BL at a was calculated as WM at the evaluated time point minus BL. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1, and mean Baseline FEV1 as fixed effects and participant as a random effect.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1363729|NCT01641692|Primary|Number of Participants With the Indicated 24 Hour Holter Findings|Twenty-four hour Holter ECG measurements were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart’s rhythm while the monitor is worn. Following the 24-hour period, the data from the monitor were downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist. The 24-hour Holter ECG measurements were obtained at during the screening period and on Day 14 of each treatment period. The number of participants with clinically significant change (abnormal or normal) were reported.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only participants with sufficient data (at least 16 hours of recorded data) at the specified time points were analyzed.|||Participants|||Number
1363730|NCT01641692|Primary|Number of Participants With the Indicated Abnormal Electrocardiogram Findings|Electrocardiograph measurements performed at Screening (Visit 1) and at Day 1 and Day 14 (pre-dose, 10 minutes post-dose and 2 hours post-dose.of each treatment period). Any clinically significant findings were identified during participant monitoring.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Participants|||Number
1363763|NCT01641367|Secondary|Change From Baseline in Fasting Values of Glucose at Week 24, 48 and 72.|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) Secondary outcome measures will be entered by December 2018.|Baseline to week 24, 48 and 72||2018-12-31|12/2018||||
1363731|NCT01641692|Primary|Urine Specific Gravity on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Day 14. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney’s ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1363732|NCT01641692|Primary|Urine pH on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine pH by dipstick method at Day 14. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1363733|NCT01641692|Primary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period|Urinalysis parameters included: Urine Bilirubin (UB), Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Nitrite (UN), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace (T), 1+, 2+, and 3+, and for UG the result can be read as Neg, T, T or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, T, 1+, 2+ and 3+ levels at Day 14.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Participants|||Number
1363734|NCT01641692|Primary|Change From Baseline in Hematocrit on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1363735|NCT01641692|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils (neut) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Percentage of cells in blood||Standard Deviation|Mean
1363736|NCT01641692|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - Absolute neutrophil [neut] count), platelet, and leucocytes count at Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
1363737|NCT01641692|Primary|Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of chloride, caron dioxide, glucose, potassium, sodium, and urea/BUN at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Micromoles/Liter (µM/L)||Standard Deviation|Mean
1363738|NCT01641692|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of direct bilirubin, indirect (ind) bilirubin, total bilirubin, and creatinine at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Micromoles/Liter (µM/L)||Standard Deviation|Mean
1363739|NCT01641692|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CK, GGT, and LDH at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||International Units/Liter (IU/L)||Standard Deviation|Mean
1364039|NCT01638468|Secondary|Change in Heart Rate|Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 2 participants were not evaluable.|||beats per minute||Standard Deviation|Mean
1363740|NCT01641692|Primary|Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Grams per liter (G/L)||Standard Deviation|Mean
1363741|NCT01641692|Primary|Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period|Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Error|Least Squares Mean
1363742|NCT01641692|Primary|Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1363743|NCT01641692|Primary|Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included systolic blood pressure (SBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1363744|NCT01641692|Primary|Number of Participants With Asthma Exacerbations During the Treatment Period|Worsening of asthma symptoms is monitored throughout the study. Severe exacerbation (deterioration of asthma requiring use of systemic corticosteroids for 3 days, inpatient hospitalization or emergency department visit due to asthma) is an exclusion criterion and requires withdrawal from the study. Asthma symptoms were assessed daily using an electronic diary throughout study.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
1363745|NCT01641692|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of SAEs.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population|||Participants|||Number
1363746|NCT01641692|Primary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1 and mean Baseline FEV1 as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Day 15 of each treatment period (up to Study Day 71)|ITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.|||Liters||Standard Error|Least Squares Mean
1363764|NCT01641367|Secondary|Change From Baseline in Fasting Values of Triglycerides at Week 24, 48 and 72.|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) Secondary outcome measures will be entered by December 2018.|Baseline to week 24, 48 and 72||2018-12-31|12/2018||||
1363765|NCT01641367|Secondary|Change From Baseline in Fasting Values of Calculated LDL-C at Week 24, 48 and 72.|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) Secondary outcome measures will be entered by December 2018.|Baseline to week 24, 48 and 72||2018-12-31|12/2018||||
1363747|NCT01641692|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|Dose-response was conducted for both QD and BID UMEC doses on trough FEV1 (measure of lung function, defined as the maximal amount of air that can be forcefully exhaled in 1 second) on D 15. Total daily dose of UMEC was used in the modeling. The null model was the final model. The null model is defined as: CFEV1,ij=(THETA1+ETA1j)*meanBL+(THETA2+ETA1j)*periodBL+EPSij, where CFEV1,ij represents the change from BL in trough FEV1 for participant j measured at period i. THETA1 and THETA2 were the slopes with respect to meanBL and periodBL, respectively. Omegas were the variance of the slopes on meanBL and periodBL (ETA1j, ETA2j) for each participant and Sigma was the variance of the residual errors (EPSij). MeanBL is the mean of the Baseline (BL) which is the FEV1 value recorded pre-dose on D 1 of each TP; periodBL is the difference between the BL and the meanBL in each TP for each participant.|Day 15 of each treatment period (up to Study Day 71)|Intent-To-Treat (ITT) Population: : all participants randomized to treatment and who received at least one dose of study medication. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.|||unitless||95% Confidence Interval|Geometric Mean
1363748|NCT01641653|Secondary|Percent Intra-op Blood Glucose Level of 140mg/dL or Less|blood glucose level will be tested perioperatively at 30 minute intervals following induction. All glucose levels will be recorded .midazolam group will maintain a blood glucose level perioperatively of 140mg/dL or less|perioperatively||||percentage of glucose levels<140|||Number
1363749|NCT01641653|Secondary|Glucose Level Percent Change From Pre-op to Maximum Glucose Level|blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min|Preoperatively, intraoperatively 30 min for duration of surgery|per protocol|||percentage of increase in glucose level||Inter-Quartile Range|Median
1363750|NCT01641653|Primary|Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements|Non diabetic subjects undergoing hernia repair were randomized into 2 groups. Midazolam vs. placebo. Blood glucose level was monitored preoperatively and following induction of anesthesia at 30 minute intervals perioperatively, and after in the PACU at 30 minutes and 60 minutes following arrival. All readings were performed using the Abbott Freestyle Glucose Monitor.|every 30 min for duration of surgery|per protocol|||mg/dL||Inter-Quartile Range|Median
1363751|NCT01641640|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1363752|NCT01641640|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.|Baseline to Week 12|Full Analysis Set|||percentage of participants|||Number
1363753|NCT01641640|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
1363754|NCT01641640|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Posttreatment Week 4|Full Analysis Set|||percentage of participants|||Number
1363755|NCT01641640|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.|Baseline to Week 12|Safety Analysis Set|||participants|||Number
1363756|NCT01641640|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.|Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
1363757|NCT01641471|Secondary|General Health Outcome - SF-12 Physical Component Summary|Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported.|6 weeks (+/- 3 days) postoperative||||z-scale||Standard Deviation|Mean
1363758|NCT01641471|Secondary|Functional Assessments|Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.|6 weeks (+/- 3 days) postoperative||||seconds||Standard Deviation|Mean
1363759|NCT01641471|Secondary|Visual Analog Pain Score (VAS)|Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.|6 weeks (+/- 3 days) postoperative||||units on a scale||Standard Deviation|Mean
1363760|NCT01641471|Primary|Narcotic Usage|Morphine Equivalent dose, mg/kg|Through 6 weeks after surgery||||morphine equivalents||Standard Deviation|Mean
1363761|NCT01641367|Secondary|Time to First Dose Modification Due to Grade 3 or 4 Toxicity.|Secondary outcome measures will be entered by December 2018.|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363762|NCT01641367|Secondary|Time From Randomization to the Development of IRIS.|Secondary outcome measures will be entered by December 2018.|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363895|NCT01640171|Secondary|Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection|The patient was asked to compare the two eyes in the way described in the study protocol on a five point scale. If one eye hurt a lot more or a little more than the other or if the two eyes were equal (neither hurt more than the other).|24 hours|total group|||participants|||Number
1363766|NCT01641367|Secondary|Change From Baseline in Fasting Values of HDL-C at Week 24, 48 and 72.|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] Secondary outcome measures will be entered by December 2018.|Baseline to week 24, 48 and 72||2018-12-31|12/2018||||
1363767|NCT01641367|Secondary|Change From Baseline in Fasting Values of Total Cholesterol at Week 24, 48 and 72.|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) Secondary outcome measures will be entered by December 2018.|Baseline to week 24, 48 and 72||2018-12-31|12/2018||||
1363768|NCT01641367|Secondary|Time From Randomization to Treatment Modification or Discontinuation Due to Toxicity.|Secondary outcome measures will be entered by December 2018.|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363769|NCT01641367|Secondary|Time From Randomization to Treatment Modification or Discontinuation.|"Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen or of the addition of a new drug. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination.~Secondary outcome measures will be entered by December 2018."|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363770|NCT01641367|Secondary|Time From Randomization to the First of Death or Hospitalization.|Secondary outcome measures will be entered by December 2018.|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363771|NCT01641367|Secondary|Time From Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event.|Secondary outcome measures will be entered by December 2018.|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363772|NCT01641367|Secondary|Time From Randomization to Death.|Secondary outcome measures will be entered by December 2018.|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363773|NCT01641367|Secondary|Change in CD4+ T-cell Count From Baseline at Week 24, 48, and 72.|"Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)~Secondary outcome measures will be entered by December 2018."|Baseline to week 24, 48, and 72||2018-12-31|12/2018||||
1363774|NCT01641367|Secondary|Time to Confirmed VF Defined as First HIV-1 RNA >1000 Copies/mL at or After 24 Weeks With a New Resistance-associated Mutation Detected in Population-based Sequencing.|"The new resistance-associated mutation is defined as one not present in the last population-based sequence obtained prior to randomization~Secondary outcome measures will be reported by December 2018."|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363775|NCT01641367|Secondary|Time to Confirmed VF Defined as First HIV-1 RNA >1000 Copies/mL at or After 24 Weeks.|"The VF has to be confirmed by the next HIV-1 RNA measurement also being >1000 copies/mL (irrespective of the time between the initial and confirmatory measurements provided that they are obtained on different days, and irrespective of ART being received at the times of these measurements). For the purposes of this outcome measure, a week 24 measurement includes any HIV-1 RNA measurement obtained at ≥7*22=154 days after randomization (to allow for the protocol-defined 14 day window for scheduling the week 24 visit)~Secondary outcome measures will be entered by December 2018."|Throughout study; participants are expected to be followed for an average of 84 weeks||2018-12-31|12/2018||||
1363776|NCT01641367|Secondary|Suppression Rate of Plasma HIV-1 RNA to ≤200 Copies/mL at Week 24 and 72|Secondary outcome measures will be entered by December 2018.|Baseline to week 24 and 72||2018-12-31|12/2018||||
1363777|NCT01641367|Primary|Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks|"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided."|48 weeks after the date of entry|All enrolled participants|||proportion of participants||95% Confidence Interval|Number
1363778|NCT01641237|Secondary|Enamel Fluoride Uptake (Corrected Data)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. Data analysis for this outcome measure was performed based on a correction factor.|||micrograms*F/centimeters^2||Standard Error|Mean
1363799|NCT01641081|Secondary|Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)|AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals|Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
1363779|NCT01641237|Secondary|Percentage Relative Erosion Resistance|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.|||% Relative Erosion Resistance||Standard Error|Mean
1363780|NCT01641237|Secondary|%SMHR|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.|||%SMHR||Standard Error|Mean
1363781|NCT01641237|Primary|Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|Per protocol population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.|||%SMHR||Standard Error|Mean
1363782|NCT01641159|Secondary|Cocaine-use Days|Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation|study week 16|All randomized participants|||proportion of cocaine use days|||Number
1363783|NCT01641159|Primary|Maximum Days of Continuous Cocaine Abstinence|The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.|study week 16||||Days||Standard Deviation|Mean
1363784|NCT01641133|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)|The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1363785|NCT01641133|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)|The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1363786|NCT01641133|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination (Month 0) up to study end (11-14 months)|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.|||Subjects|||Number
1363787|NCT01641133|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1363788|NCT01641133|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) post-primary vaccination period|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.|||Subjects|||Number
1363789|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited)|The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1363790|NCT01641133|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1363791|NCT01641133|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following each primary dose|The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.|||Subjects|||Number
1363792|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.|||Subjects|||Number
1363793|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 4-day (Days 0-3) post-vaccination period following each primary dose|The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.|||Subjects|||Number
1363794|NCT01641133|Primary|Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited)|The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.|Within 31-day (Day 0-Day 30) after any dose of primary vaccination|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.|||Subjects|||Number
1363795|NCT01641120|Secondary|Perception of Needle|"Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree).~A total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle."|Weeks 2, 3, 4, 5||||units on a scale||Standard Deviation|Mean
1363796|NCT01641120|Primary|Visual Analog Scale Score for Post-injection Pain|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size."|Weeks 2, 3, 4, 5||||cm||Standard Deviation|Mean
1363797|NCT01641120|Secondary|Fear of Injection|"Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never).~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle."|Weeks 2, 3, 4, 5||||units on a scale||Standard Deviation|Mean
1363798|NCT01641120|Primary|Change in Patient Visual Analog Scale Score for Pre-injection Anxiety|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size."|Weeks 2, 3, 4, 5||||cm||Standard Deviation|Mean
1363860|NCT01640353|Secondary|Work Status|Proportion of non-working subjects who return to work|Basline, 24 months|Participants with work status data at 24 months post-operatively who were not working due to back pain (at baseline 37.4% were not working due to back pain).|||percentage of participants|||Number
1363800|NCT01641081|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)|AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals|Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
1363801|NCT01641042|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 until the end of the ESFU (at Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1363802|NCT01641042|Secondary|Number of Subjects Reporting Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.|During the 31-day (Days 0-30) post second vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1363803|NCT01641042|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.|During the 31-day (Days 0-30) post first vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1363804|NCT01641042|Secondary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1363805|NCT01641042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
1363806|NCT01641042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
1363807|NCT01641042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
1363808|NCT01641042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
1363809|NCT01641042|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens|Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1363861|NCT01640353|Secondary|Ambulatory Status|Percentage of population fully ambulatory at 24 months post operatively.|24 months|148 participants had ambulatory status at 24 month post-operatively|||percentage of participants|||Number
1363862|NCT01640353|Secondary|Change in Quality of Life|Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits|Baseline and 24 months|148 participants had QOL information at 24 months post-operatively.|||units on a scale||Standard Deviation|Mean
1363810|NCT01641042|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values|The cut-off value for the assay was ≥ 2.0 μg/mL.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363811|NCT01641042|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values|The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363812|NCT01641042|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens|Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.|Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Titres||95% Confidence Interval|Geometric Mean
1363813|NCT01641042|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay ≥ 1:8.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363814|NCT01641042|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:4.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363815|NCT01641042|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens|Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.|At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1363816|NCT01641042|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:128.|Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363817|NCT01641042|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:8.|At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363818|NCT01641042|Secondary|Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).|One month after the second vaccine dose (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363819|NCT01641042|Secondary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).|One month after the second vaccine dose (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363878|NCT01640314|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after TIVc vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1363820|NCT01641042|Primary|Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies|Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).|One month after the first vaccine dose (at Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363821|NCT01641042|Primary|Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies|Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects [i.e. pre-vaccination rSBA antibody titers below (<) 1:8] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).|One month after the first vaccine dose (at Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
1363822|NCT01640964|Secondary|Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin|This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study.|4 weeks|Safety assessment happened on full analysis set which included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.|||Patients|||Number
1363823|NCT01640964|Secondary|Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)|Portal vein pressure was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).|Baseline, 120 min post infusion|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and this time point are included.|||mmHg||95% Confidence Interval|Mean
1363824|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
1363825|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
1363826|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
1363827|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
1363828|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.|||L/min||95% Confidence Interval|Mean
1363879|NCT01640314|Primary|Percentages of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVc vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages||95% Confidence Interval|Number
1363829|NCT01640964|Primary|Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)|"Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP).~Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion)."|Baseline, 120 min post-infusion start|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period.Only patients with a value at both baseline and this time point are included.|||mmHg||95% Confidence Interval|Mean
1363830|NCT01640964|Primary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post serelaxin infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.|||L/min||95% Confidence Interval|Mean
1363831|NCT01640951|Secondary|Percentage of Patients With Experiencing a Rebound|"Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event).~PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement."|Up to Week 264 (8 weeks post last dose)|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of participants||95% Confidence Interval|Number
1363832|NCT01640951|Secondary|Percentage of Patients With Experiencing a Relapse|"Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline.~PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement."|Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
1363833|NCT01640951|Secondary|Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)|The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.|Week 268|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only descriptive analysis done.|||Participants|||Number
1363834|NCT01640951|Secondary|EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Baseline, Week 52, Week 104, Week 156|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percent change||Standard Deviation|Mean
1363835|NCT01640951|Secondary|Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of participants|||Number
1363836|NCT01640951|Secondary|Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline, Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percent change||95% Confidence Interval|Median
1364040|NCT01638468|Secondary|Systemic Systolic Arterial Blood Pressure|Systemic systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint.|||mmHg||Standard Deviation|Mean
1363837|NCT01640951|Secondary|Percentage of Participants Achieving Investigator’s Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant’s disease state at the time of the assessments and does not attempt a comparison to any of the participant’s previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
1363838|NCT01640951|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Baseline, Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percent change||Standard Deviation|Mean
1363839|NCT01640951|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
1363840|NCT01640951|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
1363841|NCT01640951|Primary|Long-term Safety and Tolerability of Secukinumab|Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)|Week 268|Safety Set. All subjects who took at least one dose of study treatment during the extension treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.|||Percentage of participants|||Number
1363842|NCT01640925|Secondary|Number of Patients With In-hospital Mortality||up to 28 days or until first hospital discharge||||Participants|||Count of Participants
1363843|NCT01640925|Secondary|ICU Length of Stay in Days|Number of days in the ICU after enrollment in study until first ICU discharge.|up to 28 days||||days||Standard Deviation|Mean
1363844|NCT01640925|Secondary|Incidence of Skin Irritation|The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.|up to 28 days||||Participants|||Count of Participants
1363845|NCT01640925|Primary|Incidence of Nosocomial Infection|"Proportion of patients with one or more incident nosocomial infections.~Primary Efficacy Endpoints* (Composite of new nosocomial infection)~Primary Bloodstream Infection~Catheter Related Urinary Tract Infection~Ventilator-Associated Pneumonia**~Surgical Site Infection~(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints.~(**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation."|Up to 28 days||||participants|||Number
1363846|NCT01640548|Secondary|Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA||9 months|"Included participants who were treated with a bDMARD with concomitant traditional DMARD as previous treatment for RA. n is the number of participants who received particular bDMARD as previous RA treatment."|||months||Full Range|Median
1363847|NCT01640548|Secondary|Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA||9 months|"Included participants treated with a bDMARD monotherapy as previous treatment for RA prior to switch to current bDMARD monotherapy. n is the number of participants who received particular bDMARD as previous RA treatment."|||months||Full Range|Median
1363848|NCT01640548|Secondary|Duration of Treatment With the Current bDMARD Usage in Monotherapy||9 months|"Included all participants who received bDMARD monotherapy as their current treatment for RA. n is the number of participants who received that particular bDMARD as their current RA treatment."|||months||Full Range|Median
1363849|NCT01640548|Primary|Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy|Both previous and current bDMARDs were presented together for each subgroup, therefore the percentage of participants under each reason did not add up to 100%.|9 months|Included all participants who entered the retrospective chart review.|||percentage of participants||95% Confidence Interval|Number
1363850|NCT01640548|Secondary|Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). TJC and SJC assessed as part of the DAS28 outcome measure assessment were reported.|9 months|"Includes all participants who were evaluable for this outcome. n represents the number of participants who were evaluable for that particular assessment."|||joints count||95% Confidence Interval|Mean
1363851|NCT01640548|Primary|Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment|All corticosteroids and non-steroidal anti-inflammatory drugs taken as previous and current treatments for RA were coded according to the Roche international non-proprietary name dictionary.|9 months|Included all the participants who entered the retrospective chart review.|||percentage of participants|||Number
1363852|NCT01640548|Secondary|Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56 x square root (√) of TJC + 0.28 x √(SJC) + 0.70 x log natural (ESR) + 0.014 x global assessment of RA score. The formula for calculating DAS28 score using CRP value is: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log natural (CRP+1) + 0.014 x global assessment of RA score +0.96. The DAS28 score range was 0-9.4 where higher scores represented higher disease activity.|9 months|"Included the number of participants who were evaluable for DAS28 assessment. n represents the number of participants who were evaluable for that particular assessment."|||scores on a scale||95% Confidence Interval|Mean
1363853|NCT01640548|Primary|Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs in monotherapy as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who received bDMARD as monotherapy as previous treatment prior to switch to bDMARD monotherapy as current treatment.|||percentage of participants|||Number
1363854|NCT01640548|Primary|Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs with concomitant traditional DMARD as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who were previously treated with any bDMARD with concomitant traditional DMARD prior to switch to bDMARD monotherapy as current RA treatment.|||percentage of participants|||Number
1363855|NCT01640548|Primary|Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD|Traditional DMARDS for RA treatment include methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, azathioprine, chlorambucil, mercaptopurine, and mycophenolate mofetil medications. Previous RA treatment included all the treatments received prior to switching to current RA treatment.|9 months|Included all the participants who took any past traditional DMARDs.|||percentage of participants|||Number
1363856|NCT01640548|Primary|Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Current bDMARDs were defined as those with a start date on or after the date of collection, or those with a start date before the date of collection and an end date on or after the date of collection. NICE guidelines recommend the participants with severe active RA who inadequately responded to prior DMARD treatment (trial of 2 DMARDs, one which includes methotrexate) and were intolerant to methotrexate or the treatment with methotrexate considered inappropriate be treated with a biologic DMARD monotherapy.|9 months|Included all the participants who entered the retrospective chart review.|||percentage of participants|||Number
1363857|NCT01640379|Secondary|Number of Participants That Adhered to Self-treatment|Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence|Day 15|Chi-square test results from participants in the intervention and control groups who had data on adherence to treatment. Out of 149 enrolled in the intervention arm, 10 were lost to followup by 72 hours. Out of 137 enrolled in the control arm, 15 were lost by 72 hours and so are missing this outcome measure.|||Participants|||Count of Participants
1363858|NCT01640379|Primary|Number of Participants With Positive Sexually Transmitted Infection Test (STI)|STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).|90 Days|Adolescent and young adult women with pelvic inflammatory disease (PID) in Baltimore City randomized to the intervention or control group and also had results for chlamydia (CT) and gonorrhea (GC) at 90 days after enrollment. All enrolled participants were followed as long as possible for entire 90 days.|||Participants|||Count of Participants
1363859|NCT01640353|Secondary|Serious Adverse Events|Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.|Procedure, discharge, 1,3,6,12,18 and 24 months|149 participants had 24 months of follow up post-operatively.|||serious adverse event|||Number
1363863|NCT01640353|Secondary|Change in Back Dysfunction|Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%.|24 months|147 of participants had ODI at 24 months post-operatively.|||units on a scale||Standard Deviation|Mean
1363864|NCT01640353|Secondary|Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)|The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain.|24 months|148 subjects had SIJ pain scores at 24 months.|||units on a scale||Standard Deviation|Mean
1363865|NCT01640353|Primary|Subject Success|Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.|Baseline and 6 months|Of 194 subjects who were eligible and signed informed consent, 10 voluntarily withdrew prior to SIJF. All data from 12 subjects at a single center were excluded due to early termination of the site. 172 subjects were treated. 168 had 6 months of follow up.|||percentage of participants||95% Confidence Interval|Number
1363866|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|From time 0 to 120 hours||||percentage of participants|||Number
1363867|NCT01640340|Secondary|Use of Rescue Medication for Each Treatment Arm||From time 0 to 120 hours||||percentage of participants|||Number
1363868|NCT01640340|Secondary|Visual Analog Scale (VAS) Scores||Up to 7 days after completion of study treatment|VAS Scores were not collected||||||
1363869|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|Time 0 to 120 hours||||percentage of participants|||Number
1363870|NCT01640340|Secondary|Delayed CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.|24-120 hours after chemotherapy||||percentage of participants|||Number
1363871|NCT01640340|Secondary|Acute CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.|0-24 hours after chemotherapy||||percentage of particpants|||Number
1363872|NCT01640340|Primary|Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication|We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.|Up to 120 hours after completion of chemotherapy||||percentage of patients||95% Confidence Interval|Number
1363873|NCT01640327|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIVf vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
1363874|NCT01640327|Primary|Percentage of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVf vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or >60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages of Subjects||95% Confidence Interval|Number
1363875|NCT01640327|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer was >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
1363876|NCT01640327|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI antigen assay.~As per the European (CHMP) criteria seroconversion or significant increase in titer was defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer.~This criterion was met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or >30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of Subjects||95% Confidence Interval|Number
1363877|NCT01640314|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 22 after receiving one dose of TIVc.|Day 1 to Day 22|Analysis was done on the safety set population.|||Number of Subjects|||Number
1364261|NCT01636414|Primary|Blood Transfusion|Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups|Inpatient Postoperative, on average 3 days after surgery||||participants|||Number
1363880|NCT01640314|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
1363881|NCT01640314|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI cell-derived antigen assay.~As per the European (CHMP) criteria, seroconversion or significant increase in titer is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion is met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages||95% Confidence Interval|Number
1363882|NCT01640197|Secondary|Number of Participants With Significant Modulation of CBF in MCA|CBF was assessed in the middle cerebral artery (MCA) with Trans-cranial doppler via a trans- temporal acoustic window. Participants were deemed to have significant modulation of CBF in the MCA if readings differed significantly from those obtained on day 1 (baseline).|28 days|All participants who were part of the TCD component, who could provide a consistent blood flow trace, were included in the analysis.|||Participants|||Number
1363883|NCT01640197|Secondary|Number of Participants With Significant Modulation of Blood Pressure|Participants were deemed to have significant modulation of blood pressure if their readings on day 28 differed significantly from that taken on day 1 (baseline).|28 days|All participants who provided all BP readings across the study were included in the analysis.|||Participants|||Number
1363884|NCT01640197|Secondary|Number of Participants With Significant Modulation of Health|Subjective perceptions of health were assessed with the General Health Questionnaire. Participants were deemed to have significant modulation of health if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from day 1 (baseline) completion.|Day 28|Participants were included in the analysis if they had completed questionnaires correctly.|||Participants|||Number
1363885|NCT01640197|Secondary|Number of Participants With Significant Modulation of Sleep|Subjective perception of sleep quality was assessed with the PSQI. Participants were deemed to have significant modulation of sleep if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from those on day 1 (baseline).|Day 28|All participants who completed their questionnaires correctly were included in the analysis.|||Participants|||Number
1363886|NCT01640197|Secondary|Number of Participants With Modulated Cognitive Performance|Cognitive performance was assessed by a range of cognitively demanding tasks on day 28 of the supplementation period. Participants were deemed to have significant modulation of cognitive performance if their scores on these tasks were significantly different from scores taken on day 1.|28 days|All participants who properly completed all repetitions of all tasks on both days were included in the analysis.|||Participants|||Number
1363887|NCT01640197|Secondary|Number of Participants With Modulated Mood|Subjective mood was assessed with the Profile of mood states (POMS) questionnaire every 7 days during the 28- day period. Participants were deemed to have significant modulation of mood if their scores on week 1, week 2, week 3 and/or week 4 differed significantly from scores on the baseline questionnaire completed on day 1.|28 days|Participants were included in the final analysis if they had completed all questionnaires correctly.|||Participants|||Number
1363888|NCT01640197|Primary|Chronic Modulation of Cerebral Blood Flow|Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28.|40- 80 minutes post- dose on day 28 of supplementation|Participants were included in the analysis if they provided full NIRS readings on session 1 and session 2.|||Participants|||Number
1363889|NCT01640184|Secondary|Changes of Blood Levels on Bone Specific Alkaline Phosphatase.|The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||microgram/L||Standard Deviation|Mean
1363890|NCT01640184|Secondary|Changes of Blood Levels on iPTH During 12 Months.|The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||ng/ml||Standard Deviation|Mean
1363891|NCT01640184|Secondary|Changes of Blood Levels on Phosphorus During 12 Months.|The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||mmol/L||Standard Deviation|Mean
1363892|NCT01640184|Secondary|Changes of the Blood Levels on Calcium During 12 Months.|The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||mmol/L||Standard Deviation|Mean
1363893|NCT01640184|Secondary|Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).|Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.|12 months||||participants|||Number
1363894|NCT01640184|Primary|Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.|The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.|12 months|Number of participants analyzed is the number of patients completed study.|||percentage of participants|||Number
1363913|NCT01639742|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
1363896|NCT01640171|Secondary|Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection|Pain was rated on a 10 point standardized pain scale, zero was the least pain and 10 was the worst pain. The patient was questioned using a script and shown a pain scale as well as told how the pain scale worked. Then the patient gave the number that characterized their pain.|24 hours|All patients in the study|||participants|||Number
1363897|NCT01640171|Primary|Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit|Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.|up to 6 months||||participants|||Number
1363898|NCT01640054|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event|Entry in extension to study termination (variable duration; maximum 52 weeks)|The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.|||Percentage of patients|||Number
1363899|NCT01640054|Secondary|SF-36 Score Over Time|n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey|Every 12 weeks for one year then yearly until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
1363900|NCT01640054|Secondary|HAQ-DI Score Over Time|HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
1363901|NCT01640054|Secondary|DAS28-CRP Score Over Time|CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
1363902|NCT01640054|Secondary|Components of ACR Response Criteria Over Time|ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
1363903|NCT01639833|Secondary|Hemostasis at All Treated Bleeding Sites Within 3 Minutes|The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.|||percentage of participants||95% Confidence Interval|Number
1363904|NCT01639833|Primary|Time to Hemostasis (TTH)|Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.|||minutes||95% Confidence Interval|Median
1363905|NCT01639755|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.|||percentage of participants|||Number
1363906|NCT01639755|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body’s response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Participants from the Full Analysis population with data available for analysis.|||percentage of participants|||Number
1363907|NCT01639755|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
1363908|NCT01639755|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
1363909|NCT01639755|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
1363910|NCT01639742|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.|||percentage of participants|||Number
1363911|NCT01639742|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body’s response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Full analysis population included all participants.|||percentage of participants|||Number
1363912|NCT01639742|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
1364262|NCT01636362|Secondary|Percent of Study Burn Healed.|Percent of study burn healed measured by PictZar photo analysis of tissue types.|At day 21||||percentage of healing||Full Range|Median
1363919|NCT01639703|Secondary|Permeability Surface According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.|||mL/100 grams/min|lesions|Standard Deviation|Mean
1363920|NCT01639703|Secondary|Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.~Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.|||mL/100 grams/min|lesions|Standard Deviation|Mean
1363921|NCT01639703|Secondary|Blood Flow According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.|||mL/100 grams/min|lesions|Standard Deviation|Mean
1363922|NCT01639703|Secondary|Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.~Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.|||mL/100 grams/min|lesions|Standard Deviation|Mean
1363923|NCT01639703|Secondary|Blood Volume According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.|||mL/100 grams|lesions|Standard Deviation|Mean
1363924|NCT01639703|Secondary|Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.~Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.|||mL/100 grams|lesions|Standard Deviation|Mean
1363925|NCT01639703|Secondary|Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||percentage|lesions|Standard Deviation|Mean
1363926|NCT01639703|Secondary|Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation|"The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.~TLP = ALP + PVP"|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/min/100 mL|lesions|Standard Deviation|Mean
1363927|NCT01639703|Secondary|Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/min/100 mL|lesions|Standard Deviation|Mean
1363928|NCT01639703|Secondary|Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/min/100 mL|lesions|Standard Deviation|Mean
1363944|NCT01639443|Secondary|Advanced Adenoma Detection/Cecal Intubation Rates|The investigators will compare daily advanced adenomatous polyp detection and daily cecal intubation rates between groups.|After 20 months of running study in clinic|We only collected data on polyp detection for the first half of our Fast-tracked participants and all Controls seen over the same time period (4897 in total).|||Number of Polyps Detected per patient||Standard Deviation|Mean
1363929|NCT01639703|Primary|Permeability Surface (PS) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/100 grams/min|lesions|Standard Deviation|Mean
1363930|NCT01639703|Primary|Blood Flow (BF) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/100 grams/min|lesions|Standard Deviation|Mean
1363931|NCT01639703|Primary|Blood Volume (BV) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/100 grams|lesions|Standard Deviation|Mean
1363932|NCT01639560|Secondary|Prolonged Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|24 weeks||||participants|||Number
1363933|NCT01639560|Secondary|Point Prevalence Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.|24 weeks||||participants|||Number
1363934|NCT01639560|Primary|Prolonged Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|12 weeks||||participants|||Number
1363935|NCT01639560|Primary|Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.|12 weeks||||participants|||Number
1363936|NCT01639495|Secondary|Late Onset Serious Adverse Events|Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure|From 31 days post procedure to month 12|Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.|||Number of participants|||Number
1363937|NCT01639495|Secondary|Percentage of Subjects Achieved Acute Effectiveness|Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins|5 hours of procedure time|Effectiveness cohort, defined as those enrolled subjects who underwent insertion of the study catheter and an AF ablation procedure. Subjects without RF energy delivery will be excluded (i.e. discontinued subjects).|||Percentage of participants||95% Confidence Interval|Number
1363938|NCT01639495|Primary|Incidence of Primary Adverse Events Within Specified Study Period|Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.|12 months post procedure|144 subjects that had study catheter inserted into their body; INCLUDES study ineligible & untreated subjects|||percentage of subjects with primary AE||95% Confidence Interval|Number
1363939|NCT01639495|Secondary|Peri-procedural Serious Adverse Events|Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure|Within 8-30 days post procedure|Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.|||Number of participants|||Number
1363940|NCT01639495|Primary|Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias|"Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as atrial tachyarrhythmias) based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures"|Day 91-361|137 Study-eligible subjects with per-protocol procedure. CENSORED: 1 lost to follow-up subject without recurrence|||Percentage of participants||95% Confidence Interval|Number
1363941|NCT01639469|Primary|Total Falls During the 1-year Follow-up|Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.|up to 1 year|"2 participants not analyzed were excluded due to early loss to follow-up and had no fall data collected."|||Total count of falls|||Number
1363942|NCT01639443|Secondary|Cost Comparisons|For cost comparisons, the investigators will aggregate total provider overtime costs for colonoscopies performed. Cost is reported per day.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||dollars||Standard Deviation|Mean
1363943|NCT01639443|Secondary|Length of Workday|Length of Workday in hours (comparing days with Fast-Tracked Appointments to Control days without)|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||hours||Standard Deviation|Mean
1363945|NCT01639443|Secondary|"Daily Service Denials (Bumps)"|The investigators will compare the number of patients bumped per day between scheduling approaches|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||participants|||Number
1363946|NCT01639443|Secondary|Scheduling-to-procedure Lag Time|The investigators will calculate the mean daily lag time for all colonoscopy and upper endoscopies performed per day|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||days||Standard Deviation|Mean
1363947|NCT01639443|Primary|Percentage of GI Clinic Capacity Filled|Investigators' primary objective will be to evaluate the impact of no-show predictive overbooking on percentage of the GI endoscopy clinic that are filled on a given day. Days where at least one Fast-tracked patient attended an appointment were compared to days where only Control patients attended appointments. Percentage of GI Clinic Capacity is calculated as the number of appointments completed divided by number of appointment spots available on a given day. This percentage was compared between Fast-tracked days and Control days, using data from 1672 patients.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||percentage of clinic capacity filled||Standard Deviation|Mean
1363948|NCT01639352|Secondary|Toxicity Profile of Protocol Therapy|Number of patients experiencing adverse events and/or toxicities while receiving protocol therapy.|Up to 2 Years||||Participants|||Count of Participants
1363949|NCT01639352|Secondary|Duration of Overall Response|Duration of Overall Response in participants achieving complete response (CR) or partial response (PR) to SOM230 treatment. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Overall response is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 2 Years|No participants achieved complete response (CR) or partial response (PR) to protocol therapy.||||||
1363950|NCT01639352|Secondary|Overall Response Rate (ORR)|Proportion of patients achieving Complete Response and Partial Response (CR+PR) to protocol therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 2 Years||||Participants|||Count of Participants
1363951|NCT01639352|Secondary|Rate of Overall Survival (OS)|Rate of Overall Survival (OS) in participants receiving protocol therapy. OS will be measured from the date of enrollment to the date of death or last contact.|From Enrollment Until Study Completion, Approximately 3 Years||||months||95% Confidence Interval|Median
1363952|NCT01639352|Secondary|Rate of Progression-Free Survival (PFS):|Rate of Progression-Free Survival (PFS). PFS will be measured from the date of enrollment to the earliest date of documented disease progression or death from any cause, whichever is earlier. Progression is defined according to RECIST v 1.1 criteria as an at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who remain alive without progression, follow up time will be censored at the date of last disease assessment.|From Enrollment Until Study Completion, Approximately 3 Years||||months||95% Confidence Interval|Median
1363953|NCT01639352|Primary|Disease Control Rate (DCR)|The disease-control rate (DCR) is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response or stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan, and that is maintained for at least 8 weeks. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|At least 2 cycles, about 8 weeks||||Participants|||Count of Participants
1363954|NCT01639222|Secondary|Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)|To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.|Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose|PK/PD set|||liters||Standard Deviation|Mean
1363955|NCT01639222|Primary|Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum|The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.|Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.|PK/PD set|||h*pg/mL||Standard Deviation|Mean
1363956|NCT01639222|Primary|Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)|Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.|Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Set included all enrolled subjects who received at least one dose of the mock treatment who had reliable values of either the primary PK parameter Ca2+ Ae0-6h in both periods or the primary PD parameter PTH AUC0-6h in both periods.|||mmol||Standard Deviation|Mean
1406615|NCT01206465|Secondary|Pharmacokinetics of 5-FU - Cmax Plasma Levels|5-FU plasma levels|22, 23, 45 & 46 hours during the 48 hour infusion||||mg/m^2||Standard Deviation|Mean
1363957|NCT01639157|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||beats per minute||Standard Error|Mean
1363958|NCT01639157|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||mmHg||Standard Error|Mean
1363959|NCT01639157|Secondary|Peak Oral Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||Degrees Fahrenheit||Standard Error|Mean
1363960|NCT01639157|Secondary|"Peak Ratings of Talkative, Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative, Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363961|NCT01639157|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363962|NCT01639157|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363963|NCT01639157|Secondary|"Peak Ratings of Sluggish, Fatigued, Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish, Fatigued, Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363964|NCT01639157|Secondary|"Peak Ratings of Shaky, Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky, Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363965|NCT01639157|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363966|NCT01639157|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363967|NCT01639157|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363968|NCT01639157|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1364263|NCT01636362|Primary|Proportion of Subjects Healed at Day 21.|The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.|Healing will be assessed after 21 days.||||participants|||Number
1363969|NCT01639157|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363970|NCT01639157|Secondary|"Peak Ratings of Nervous, Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous, Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363971|NCT01639157|Secondary|"Peak Ratings of Nauseated, Queasy, Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated, Queasy, Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363972|NCT01639157|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363973|NCT01639157|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363974|NCT01639157|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363975|NCT01639157|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363976|NCT01639157|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363977|NCT01639157|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363978|NCT01639157|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1363979|NCT01639157|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
1364036|NCT01638507|Primary|Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)||12 months|The primary analysis set was the Intent-To-Treat (ITT) population, defined as all patients who signed the written informed consent and were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
1363980|NCT01639157|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitrary units on a Likert-type scale||Standard Error|Mean
1363981|NCT01639157|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||mmHg||Standard Error|Mean
1363982|NCT01639157|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitrary units on a Likert-type scale||Standard Error|Mean
1363983|NCT01639157|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her 2 week inpatient admission||||Number of Cocaine Choices||Standard Error|Mean
1363984|NCT01639144|Primary|Postoperative Infection and Delayed Wound Healing.|Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).|Infection: 30 days after surgery. Delayed wound healing: 60 days.|Patients have foot and/or ankle surgery.|||participants|||Number
1363985|NCT01639040|Other Pre-specified|Percent Change in Eczema Area and Severity Index (EASI) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF|EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percent Change||Standard Deviation|Mean
1363986|NCT01639040|Other Pre-specified|Percent Change in Investigator's Global Assessment (IGA) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percent change||Standard Deviation|Mean
1363987|NCT01639040|Other Pre-specified|"Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 at Day 29"|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).|Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percentage of participants||95% Confidence Interval|Number
1363988|NCT01639040|Other Pre-specified|Percent Change in Pruritus Numerical Rating Scale (NRS) From Day 1 (Baseline) to Day 29 (Week 4)|Pruritus NRS was an assessment tool that was used to report the intensity of participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percent change||Standard Deviation|Mean
1363989|NCT01639040|Other Pre-specified|Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score: Reduction of ≥50 at Day 29 - Censored Last Observation Carried Forward (LOCF)|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Day 29|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percentage of participants||95% Confidence Interval|Number
1364264|NCT01636362|Primary|Number of Subjects Healed at Day 14.|> = 95 % epitheliazation|Healing will be assessed after 14 days.||||participants|||Number
1363990|NCT01639040|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of study [up to Day 78]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to the end of study (up to Day 78)|Safety population included all randomized participants who received any study drug; based on the treatment received (as treated).|||percentage of participants|||Number
1363991|NCT01639001|Secondary|Percentage of Participants With Treatment-emergent AEs (Treatment Related)|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in the below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death related to AE. Chemotherapy group in the below table, only includes data before crossover to crizotinib for those participants who crossed over to receive crizotinib treatment.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses (assessed up to 33 months)|All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||Percentage of participants|||Number
1363992|NCT01639001|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (AEs; All Causalities)|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Chemotherapy group in the below table includes data before crossover to crizotinib for participants who crossed over to receive crizotinib.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses (assessed up to 33 months)|All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||Percentage of participants|||Number
1363993|NCT01639001|Secondary|Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable|Agreement between central laboratory anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) and ALK immunohistochemistry (IHC) test results is based on analysis of participants in the Molecular Profiling (MP) evaluable population that have an ALK IHC result and an ALK FISH result of either positive or negative only. This MP evaluable population included participants who screen failed, which their ALK test results were negative based on FISH test. Tumor tissue samples from these screen failure participants were consented and kept. These samples served as a part of negative sample set for evaluation of IHC test and/or polymerase chain reaction (PCR) to determine ALK fusion events. Participants with FISH results of uninformative and assay not performed and IHC results of valid IHC status not available were excluded from the analysis of agreement between central laboratory ALK FISH and ALK IHC test results.|Screening, less than or equal to 28 days prior to dosing.|The MP evaluable population included 812 participants, of which there were 771 participants that had a test result (positive or negative) from both the FISH test and the IHC test.|||Number of participants|||Number
1363994|NCT01639001|Secondary|Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK)|"The participants who responded to the question: Have you experienced any visual disturbances? Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question."|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Percentage of participants|||Number
1363995|NCT01639001|Secondary|Change From Baseline in General Health Status as Assessed by EQ-5D- Index|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
1364037|NCT01638468|Secondary|Procedure Related Adverse Event Rate|Number of procedure related adverse events occurring within 3 months of the index procedure|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||events|||Number
1364265|NCT01636258|Secondary|Sleep|Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).|baseline and followup visit (at 8-14 weeks)||||hours/night||Inter-Quartile Range|Mean
1363996|NCT01639001|Secondary|Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
1363997|NCT01639001|Secondary|Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Alopecia, Coughing, Dysphagia, Dyspnoea, Haemoptysis, Pain in arm or shoulder, Pain in chest, Pain in other parts, Peripheral neuropathy, and Sore mouth each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
1363998|NCT01639001|Secondary|Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Appetite loss, Constipation, Diarrhea, Dysponea, Fatigue, Financial difficulties, Insomnia, Nausea/vomiting, and Pain each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
1363999|NCT01639001|Secondary|Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Global QOL, Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, and Social Functioning each ranged from 0-100 with higher scores indicating a better level of functioning or better quality of life.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
1364000|NCT01639001|Secondary|Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough|TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms.|From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Months||95% Confidence Interval|Median
1364001|NCT01639001|Secondary|Extracranial Time To Progression (EC-TTP) Based on IRR|EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions.|Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
1364002|NCT01639001|Secondary|Intracranial Time To Progression (IC-TTP) Based on IRR|IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases.|Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
1364003|NCT01639001|Secondary|Time To Progression (TTP) Based on IRR|TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
1364038|NCT01638468|Secondary|Vasopressor Support|Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||percentage of participants|||Number
1364004|NCT01639001|Secondary|Time to Tumor Response (TTR) Based on IRR|TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response.|Randomization to first documentation of objective tumor response (assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR.|||Weeks||Full Range|Median
1364005|NCT01639001|Secondary|Duration of Response (DR) Based on IRR|DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death − first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response.|From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR.|||Weeks||95% Confidence Interval|Median
1364006|NCT01639001|Secondary|Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months|Probability of survival 1 year and 18 month after randomization. The probability of survival at 1 year was estimated using the Kaplan Meier method and a 2-sided 95% CI for the log [-log(1-year survival probability)] was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival probability itself. The probability of survival at 18 months was estimated similarly.|From randomization to 18 months|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Percentage of paricipants||95% Confidence Interval|Number
1364007|NCT01639001|Secondary|Percentage of Participants With Disease Control at 12 Weeks Based on IRR|Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization to Week 12|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Percentage of participants||95% Confidence Interval|Number
1364008|NCT01639001|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − date of randomization +1)/30.44.|From randomization to death or last date known alive for those not known to have died (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
1364009|NCT01639001|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR|Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Percentage of participants||95% Confidence Interval|Number
1364010|NCT01639001|Primary|Progression-Free Survival (PFS) Based on IRR by Treatment Arm|PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date − randomization date +1)/30.44. Progression is defined using RECIST v1.1, as at least a 20% increase (including an absolute increase of at least 5 millimeters) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
1364011|NCT01638819|Secondary|Change in Knowledge and Fluid Reasoning (Scaled Score, Range 1-19 for Each Subtest)|The Stanford Binet, version 5, was used to assess the brain function. It can assess the level of intelligence across several age spans and ability levels. The Stanford-Binet looks at intelligence in five areas. In this study 2 areas were looked at: Knowledge and Fluid Reasoning that were age and condition appropriate. Each sub-test has a mean of 10 and a standard deviation of 3. The standard deviation indicates how far above or below the norm the subject's score is. Scores of 7 to 13 are considered to be within the average range of functioning.|Baseline and 6 months|Please note that endpoints for only the first 24 weeks were recorded due to the fact that the placebo second group may not be a true placebo group (stem cell infusion does not necessarily wash out like a drug).|||units on a scale||Standard Deviation|Mean
1376634|NCT01490931|Primary|Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||3 hours post-dose||||millimeters||Standard Error|Mean
1364012|NCT01638819|Secondary|Change in Behavior/Learning (Standard Score, Range 40 - 160 for Each Subtest)|"Change in the Vineland Adaptive Behavior and Socialization Scales (2nd edition) between baseline and six months after infusion of AUCB containing stem cells.~Vineland Adaptive Behavior and Socialization Scales consist of the following subparts: Daily Living Skills, Socialization, and Adaptive Behavior Composite (ABC). These are questionnaires completed by a parent or caregiver. Scores above 80 are classified using approximately the same ranges as IQ tests. Scores below 80 are categorized as borderline adaptive functioning (70–80); mildly deficient adaptive functioning (51–69); moderately deficient adaptive behavior (36–50); severely deficient adaptive behavior; (20–35); and markedly or profoundly deficient adaptive behavior (<20)."|Baseline and 6 months|Please note that endpoints for only the first 24 weeks were recorded due to the fact that the placebo second group may not be a true placebo group (stem cell infusion does not necessarily wash out like a drug).|||units on a scale||Standard Deviation|Mean
1364013|NCT01638819|Primary|Change in Language (Total Standard Score, Range 40 - 160)|"Change in language as measured by the Receptive One-Word Vocabulary Test (ROWVT-4) and Expressive One-Word Vocabulary Test (EOWVT-4) at baseline and six months following infusion of stem cells from AUCB or infusion of placebo.~The ROWPVT-4 and EOWPVT-4 were administered by a neuropsychologist and are norm-referenced assessments. The ROWPVT-4 tests an individual’s ability to match a spoken word with an image of an object, action, or concept. The EOWPVT-4 tests an individual’s ability to name, with one word, objects, actions, and concepts when presented with color illustrations. The tests target the ability to understand the meaning of words spoken and name what is depicted on a test plate without context.~Scores of 85-115 are considered to be within the average range of functioning."|Baseline and 6 months|Please note that endpoints for only the first 24 weeks were recorded due to the fact that the placebo second group may not be a true placebo group (stem cell infusion does not necessarily wash out like a drug).|||units on a scale||Standard Deviation|Mean
1364014|NCT01638559|Primary|Number of Operationally Tolerant Participants|The number of participants that are operationally tolerant, defined as those who successfully withdraw from immunosuppression and maintain normal allograft status as assessed by liver biopsy and liver tests 12 months after complete immunosuppression withdrawal.|12 Months after Complete immunosuppression withdrawal|Per Protocol|||Participants|||Count of Participants
1364015|NCT01638546|Other Pre-specified|RAD51 Expression, Assessed by Immunohistochemistry|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
1364016|NCT01638546|Other Pre-specified|PTEN Expression, Assessed by Immunohistochemistry|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
1364017|NCT01638546|Other Pre-specified|Presence of MGMT Promoter Methylation, Assessed by the EpiTyper Assay|Results will be expressed as binary variables. Associations with objective response, with progression free survival and with overall survival will be tested using Fisher's exact test and log-rank test, respectively.|Up to 5 years|||||||
1364018|NCT01638546|Other Pre-specified|PARP-1 Expression|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
1364019|NCT01638546|Other Pre-specified|Number of Circulating Tumor Cells|The number of CTCs will be correlated with PFS and OS using Cox proportional hazards model. The change in CTCs will be correlated with radiographic response. The number of CTCs at baseline will be correlated with patient characteristics (disease burden, location of metastases, and progression at existing sites or new sites of disease). The number of CTC will be explored as a continuous variable and the presence of a threshold predictive of the outcome will be investigated.|Up to 5 years|||||||
1364020|NCT01638546|Other Pre-specified|MGMT Expression, Assessed by Immunohistochemistry|Results will be expressed as binary variables. Associations with objective response, with progression free survival and with overall survival will be tested using Fisher's exact test and log-rank test, respectively.|Up to 5 years|||||||
1364021|NCT01638546|Other Pre-specified|GammaH2AX Levels|Wilcoxon test will be used to compare the percentage increase of gammaH2AX positive cells between the two treatment groups.|Up to 5 years|||||||
1364022|NCT01638546|Other Pre-specified|Changes in Plasma Markers|Correlated with outcome in the two treatment arms.|Baseline to up to 5 years|||||||
1364023|NCT01638546|Other Pre-specified|BRCA1 Expression, Assessed by Immunohistochemistry|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
1364024|NCT01638546|Secondary|Overall Survival|Estimated in each treatment group using Kaplan-Meier method. Group comparisons will be performed using log-rank test.|From randomization to time of death, assessed up to 5 years||||months||95% Confidence Interval|Median
1364025|NCT01638546|Secondary|ORR by RECIST 1.1 Criteria|Corresponding exact two-sided 95% confidence intervals will be calculated and reported in both arms of the study. Comparisons between treatment arms will be performed using Fisher-exact test.|Assessed up to 5 years|||||||
1364026|NCT01638546|Primary|Progression-free Survival, Calculated as the Proportion of Patients Alive and Without Evidence of Disease|Compared across the two arms using a Fisher exact test.|From randomization to time of progression or death, whichever occurs first, assessed at 4 months||||percentage of participants|||Number
1364027|NCT01638507|Secondary|Clinical Endpoint: Bleeding Complications in General||12 months||||percentage of bleeding complications|||Number
1364028|NCT01638507|Secondary|Clinical Endpoint: Stroke||12 months||||percentage of strokes|||Number
1364029|NCT01638507|Secondary|Clinical Endpoint: ST||12 months||||percentage of ST|||Number
1364030|NCT01638507|Secondary|Clinical Endpoint: MI||12 months||||percentage of MIs|||Number
1364031|NCT01638507|Secondary|Clinical Endpoint: TVR||12 months||||percentage of TVR|||Number
1364032|NCT01638507|Secondary|Clinical Endpoint: TLR||12 months||||percentage of TLR|||Number
1364033|NCT01638507|Secondary|Dual Antiplatelet Therapy (DAPT) Compliance||12 months||||percentage of compliance|||Number
1364034|NCT01638507|Secondary|Clinical Endpoint: Death||12 months||||percentage of death|||Number
1364035|NCT01638507|Secondary|Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI||12 months||||percentage of composite|||Number
1364041|NCT01638468|Secondary|Change in Systemic Systolic Arterial Blood Pressure|Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||mmHg||Standard Deviation|Mean
1364042|NCT01638468|Secondary|Pulmonary Systolic Arterial Blood Pressure|Pulmonary systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participants were not evaluable.|||mmHg||Standard Deviation|Mean
1364043|NCT01638468|Secondary|Change in Systolic Pulmonary Arterial Blood Pressure|Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participant was not evaluable.|||mmHg||Standard Deviation|Mean
1364044|NCT01638468|Secondary|Death - Cardiac Cause|Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||participants|||Number
1364045|NCT01638468|Secondary|Death - All Cause|Number of participant deaths due to any reason occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||participants|||Number
1364046|NCT01638468|Secondary|Technical Success|Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||percentage of participants|||Number
1364047|NCT01638468|Primary|Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography|The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.|Baseline to 24-48 hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||ratio||Standard Deviation|Mean
1364048|NCT01638312|Primary|Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform|"This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection.~1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units.~σ≧10 abnormal positive (+) σ＜10 normal negative (-)"|Participants provided urine samples once||||participants|||Number
1364049|NCT01638000|Secondary|Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
1364050|NCT01638000|Secondary|Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
1364051|NCT01638000|Secondary|Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit|A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to final visit (up to Week 12)|FAS population. LOCF was used.|||percentage of participants|||Number
1364052|NCT01638000|Secondary|Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12|A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to Week 12|FAS population.|||percentage of participants|||Number
1364053|NCT01638000|Secondary|Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
1364054|NCT01638000|Secondary|Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
1364055|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient’s Assessment of Treatment Satisfaction Questionnaire-Likert Scale|"The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1364251|NCT01636453|Secondary|Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2|The Modified Rankin Scale measures functional ability on a scale from 0-5, with 0 indicating no symptoms at all and 5 indicating severe disability.|At 12 months post-implant||||Participants|||Count of Participants
1364056|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)|"The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1364057|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)|The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants’ perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1364058|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q|The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1364059|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1364060|NCT01638000|Secondary|Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
1364061|NCT01638000|Secondary|Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
1364062|NCT01638000|Secondary|Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
1364063|NCT01638000|Secondary|Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
1364064|NCT01638000|Secondary|Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
1364065|NCT01638000|Secondary|Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364256|NCT01636453|Secondary|Number of Participants With Device-related Serious Adverse Events|The number of participants with device-related Serious Adverse Events as a measure of safety of the procedure and device. The FDA definitions for Serious Adverse Events are used.|During the procedure||||Participants|||Count of Participants
1364066|NCT01638000|Secondary|Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364067|NCT01638000|Secondary|Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364068|NCT01638000|Secondary|Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364069|NCT01638000|Secondary|Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364070|NCT01638000|Secondary|Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364071|NCT01638000|Secondary|Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364072|NCT01638000|Secondary|Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364073|NCT01638000|Secondary|Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364074|NCT01638000|Secondary|Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364075|NCT01638000|Secondary|Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364076|NCT01638000|Secondary|Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364143|NCT01637272|Secondary|Response Rate in Pulse Rate|Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.|at baseline, M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||Percentage of participants|||Number
1364077|NCT01638000|Secondary|Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364078|NCT01638000|Secondary|Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
1364079|NCT01638000|Secondary|Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire|The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who have non-missing values at both Baseline and specified visit.|||participants|||Number
1364080|NCT01638000|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
1364081|NCT01638000|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
1364082|NCT01638000|Secondary|Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint.|||percentage of participants|||Number
1364083|NCT01638000|Secondary|Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||nocturia episodes||Standard Error|Least Squares Mean
1364084|NCT01638000|Secondary|Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||nocturia episodes||Standard Error|Mean
1364085|NCT01638000|Secondary|Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment|The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8 , Week 12|FAS population. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.|||pads||Standard Error|Least Squares Mean
1364086|NCT01638000|Secondary|Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit|The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.|||pads||Standard Error|Mean
1364087|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency|Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
1364132|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).|||hr*ng/mL||Standard Deviation|Mean
1364088|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point.|||urgency episodes||Standard Error|Least Squares Mean
1364089|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1364090|NCT01638000|Secondary|Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||urgency incontinence episodes||Standard Error|Mean
1364091|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. N is the number of participants with available data at each time point.|||incontinence episodes||Standard Error|Least Squares Mean
1364092|NCT01638000|Secondary|Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||incontinence episodes||Standard Error|Mean
1364093|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours||Baseline and Week 4, Week 8, Week 12|Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point.|||micturitions||Standard Error|Least Squares Mean
1364094|NCT01638000|Secondary|Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period|A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).|From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)|SAF population|||percentage of participants|||Number
1364095|NCT01638000|Primary|Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and final visit (up to Week 12)|Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used.|||micturitions||Standard Error|Least Squares Mean
1364096|NCT01637961|Other Pre-specified|Aurora A Kinase Expression|Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).|Up to 5 years|||||||
1364097|NCT01637961|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|every other cycle for the first 6 months; then every 3 months thereafter until disease progression is confirmed; up to 5 years|Eligible and treated patients|||months||90% Confidence Interval|Median
1364098|NCT01637961|Secondary|Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0||Every cycle during treatment and 30 days after the last treatment, up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
1364099|NCT01637961|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
1364100|NCT01637961|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for the first 6 months; then every 3 months thereafter until withdrawal from study treatment or disease progression is confirmed.|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1364101|NCT01637961|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.|Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1364102|NCT01637935|Secondary|Stage of Bladder Cancer (10 Year Analysis)||January 1, 1997 to December 31, 2012|Participants diagnosed with bladder cancer.|||percentage of participants|||Number
1364103|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.|||events per 100,000 person years||95% Confidence Interval|Number
1364104|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.|||events per 100,000 person years||95% Confidence Interval|Number
1364105|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012||||events per 100,000 person years||95% Confidence Interval|Number
1364106|NCT01637935|Primary|Incident Diagnosis of Bladder Cancer (10-year Analysis)|Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.|January 1, 1997 to December 31, 2012|All participants.|||events per 100,000 person years||95% Confidence Interval|Number
1364107|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
1364108|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
1364109|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
1364110|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
1364111|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
1364266|NCT01636258|Secondary|Stress|Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.|baseline and followup visit (at 8-14 weeks)||||scores on a scale||Inter-Quartile Range|Mean
1364112|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
1364113|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline|The SOWS is a subjective scale self-evaluated by the subject. The SOWS shows items reflecting the common motor, autonomic, gastrointestinal, musculo-skeletal, and psychic symptoms of opiate withdrawal. Subjects are instructed to rate each symptom on a scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely) at designated times [c.f. Section 3.1]. The minimum possible SOWS score is 0, the maximum 64. The following subjective criteria are answered by the subject using the scale below: 1) I feel anxious, 2) I feel like yawning 3) I am perspiring, 4) My eyes are watering, 5) My nose is running, 6) I have goose flesh, 7) I am shaking 8) I have hot flushes, 9) I have cold flushes, 10) My bones and muscles ache, 11) I feel restless, 12) I feel nauseous, 13) I feel like vomiting, 14) My muscles twitch, 15) I have cramps in my stomach, 16) I feel like shooting up now. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.|||units on a scale||Full Range|Median
1364114|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
1364115|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/ml]||Geometric Coefficient of Variation|Geometric Mean
1364116|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
1364117|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline|The OOWS is conducted by a trained independent examiner for either the presence or absence of the following symptoms during a 10 minute observation period at designated times during the trial. The minimum possible OOWS score is 0 and the maximum possible score is 13. Objective criteria: Yawning, Rhinorrhoea, Piloerection, perspiration, lacrimation, mydriasis, hot and cold flushes, restlessness, vomiting, tremors, anxiety, muscle twitches, abdominal cramps. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.|||units on a scale||Full Range|Median
1364118|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
1364119|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
1364142|NCT01637272|Secondary|﻿Response Rate in Hematocrit Levels|﻿Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||Percentage of participants|||Number
1364120|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng*h/ml]||Geometric Coefficient of Variation|Geometric Mean
1364121|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
1364122|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/ml]||Geometric Coefficient of Variation|Geometric Mean
1364123|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
1364124|NCT01637870|Primary|Wound Complication Rate|Wound infection, separation or deep infection|Up to 6 weeks from time of surgery||||participants|||Number
1364125|NCT01637584|Secondary|Pittsburgh Sleep Quality Index (PSQI):|Self-report sleep quality measure. Scores range from 0 to 21, with higher scores reflecting poorer sleep quality.|Baseline and post-treatment at 8-10 weeks|9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to prazosin provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.|||units on a scale||Standard Deviation|Mean
1364126|NCT01637584|Primary|Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose|The reported Z value reflect the magnitude of the state difference (Wake vs. Non-REM or Wake vs. REM) within the prazosin group pre-to-post treatment, and after using a mask to adjust for the spurious effects of the passage of time.|Baseline and post-intervention at 8-10 weeks|9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to placebo provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.|||Z values|||Number
1364127|NCT01637272|Secondary|LAR PK Parameter: Ctrough - at Steady State (ss) by Dose|In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.|M4 to M12|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||ng/mL||Standard Deviation|Mean
1364128|NCT01637272|Secondary|Pasireotide Concentrations in LAR Phase|Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)|M7 to M12|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||ng/mL||Standard Deviation|Mean
1364129|NCT01637272|Secondary|Summary of LAR PK Parameters by Dose|Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)|M4 to M6|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||ng/mL||Standard Deviation|Mean
1364130|NCT01637272|Secondary|Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)||M4 to M6|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||hr*ng/mL||Standard Deviation|Mean
1364131|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).|||hr||Full Range|Median
1364267|NCT01636258|Secondary|Exercise|Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).|Baseline and final followup visits (at 8-14 weeks)||||steps/day||Inter-Quartile Range|Mean
1364133|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).|||ng/mL||Standard Deviation|Mean
1364134|NCT01637272|Secondary|Patient Global Assessment at the End of Months 3, 6 and 12|"Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question:~“Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study” .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better)."|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
1364135|NCT01637272|Secondary|﻿Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12|Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 & 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early & late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) – max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
1364136|NCT01637272|Secondary|﻿Dumping Severity Score (DSS) at the End of Months 3, 6 and 8|Absolute Dumping Severity Score (DSS) scores at end of M3, M6 & M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early & late scores. DSS Range (min (absent) – max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.|M3, M6, M8|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
1364137|NCT01637272|Secondary|﻿Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)|Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
1364138|NCT01637272|Secondary|﻿﻿Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT|Absolute ﻿﻿﻿Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.|M3, M6, M12|"The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.~The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase."|||pmol/L||Standard Deviation|Mean
1364139|NCT01637272|Secondary|﻿﻿Glucagon-like Peptide 1 (GLP-1) Levels During OGTT|Absolute ﻿Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||pmol/L||Standard Deviation|Mean
1364140|NCT01637272|Secondary|﻿Glucagon Levels During OGTT|Absolute glucagon levels at the end of Months 3, 6 & 12|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||pmol/L||Standard Deviation|Mean
1364141|NCT01637272|Secondary|﻿Insulin Levels During OGTT|Absolute insulin levels at the end of M3, M6, M12|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||pmol/L||Standard Deviation|Mean
1364160|NCT01637077|Secondary|The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel|The percentage of patients who report the development of new aches/pains that they attribute to paclitaxel in the first week of chemotherapy are reported by arm below.|From treatment initiation to 6 days following treatment initiation; up to 7 days||||percentage of patients|||Number
1364144|NCT01637272|Secondary|Response Rate in Plasma Glucose Level|Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)|at Month 6 (M6), Month 12 (M12)|The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||percentage of participants||95% Confidence Interval|Number
1364145|NCT01637272|Primary|Response Rate in Plasma Glucose Level|Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase|at Month 3 (M3)|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.|||percentage of participants||95% Confidence Interval|Number
1364146|NCT01637246|Secondary|Percentage of Patients Continuing on Therapy After 12 Weeks|Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
1364147|NCT01637246|Secondary|Percentage of Patients Who Maintained Better Compliance With Treatment|Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
1364148|NCT01637246|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
1364149|NCT01637246|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
1364150|NCT01637246|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1364151|NCT01637090|Secondary|Effect of mTOR on Tumors|Determine mTOR (mammilian target of rapamycin) pathway activation and number of regulatory T cells (Tregs) in pre-treated tumor tissue and evaluate changes following treatment|one year|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
1364152|NCT01637090|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Determine the adverse event profile and tolerability of everolimus in patients with CTCL|Up to one year||||participants|||Number
1364153|NCT01637090|Secondary|Progression-free Survival|Determine progression-free survival of CTCL patients treated with everolimus|two years after discontinuing study treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
1364154|NCT01637090|Secondary|Time to Response|Determine time to response (TTR)/duration of objective response (DOR)|three months|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
1364155|NCT01637090|Primary|Efficacy of Treatment|Determine the efficacy of everolimus in the treatment of CTCL as overall response rate (ORR)|12 months after beginning treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
1364156|NCT01637077|Secondary|Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales|Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory, Autonomic, and Motor Neuropathy Subscales. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48), motor (items 37, 38, 41-45, 49), and autonomic (items 46, 47, 50) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the 6-month assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to 6-months are averaged to yield the aAUCpa per patient per subcale.|From treatment initiation to 6 months.||||average(subscale value*assessment)||Standard Deviation|Mean
1364157|NCT01637077|Secondary|The Percentage of Patients Who Report, at Week’s End, Using Opioids|"The percentage of patients who report, at week’s end, using opioids (Have you used opioids like codeine, oxycodone, or morphine for this pain over the past week?) are reported by arm below. This question was only supposed to be answered by patients who responded yes to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||percentage of patients|||Number
1364158|NCT01637077|Secondary|The Percentage of Patients Who Report, at Week’s End, Using Non-prescription Pain Medications|"The percentage of patients who report, at week’s end, using non-prescription pain medications (Have you used non-prescription meds like aspirin, Tylenol, Motrin, Ibuprofen, or Advil over the past week?) are reported by arm below. This question was only supposed to be answered by patients who responded “yes” to the first question. Currently, all responses are included, regardless of whether the patient should’ve responded or not."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||percentage of patients|||Number
1364159|NCT01637077|Secondary|The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)|"The worst pain reported at the end of the week for the overall week (New aches and pains at their worst over the past week) are reported below. This question was only supposed to be answered by patients who responded “yes” to the first question. Currently, all responses are included, regardless of whether the patient should’ve responded or not. The worst pain reported at the end of the week for the overall week (item 2 appendix V: Please rate any aches/pains that you have by circling ONE number that best describes your aches/pains at its worst over the last week.) Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be)."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||units on a scale||Standard Deviation|Mean
1364163|NCT01637077|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment||||percentage of patients|||Number
1364164|NCT01637077|Secondary|Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.|"Average Area Under the Curve per assessment (aAUCpa) of worst, average, and least pain (items 1-3 app. IV; Please rate any aches/pains that are NEW since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment by circling ONE number that best describes your aches/pains at its WORST in the last 24 hours., Please rate the same aches/pains by circling the ONE number that best describes your aches/pains at its LEAST in the last 24 hours., Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.) for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the day-6 assessment."|From treatment initiation to 6 days following treatment initiation; up to 7 days|The number analyzed for average pain over the past 24 hours differs from the overall number analyzed due to missing data.|||average(subscale value*assessment)||Standard Deviation|Mean
1364165|NCT01637077|Primary|Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).|"Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.) over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be)."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||units on a scale||Standard Deviation|Mean
1364166|NCT01637077|Primary|Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score|Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).|From treatment initiation to 6 days following treatment initiation; up to 7 days||||units on a scale||Standard Deviation|Mean
1364167|NCT01636986|Primary|Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ|Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.|Day 0, Week 4|All enrolled and randomized participants who completed the study.|||Units on a scale||Standard Deviation|Mean
1364168|NCT01636960|Secondary|Number of Participants Discontinuing Study Drug Because of AEs|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose to last dose of treatment; up to 260 Weeks|All participants receiving at least one dose of study drug.|||Participants|||Number
1364169|NCT01636960|Secondary|Safety: Number of Participants Experiencing Adverse Events (AEs)|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose through follow-up; up to 265 Weeks|All participants who received at least one dose of study drug.|||Participants|||Number
1364170|NCT01636960|Primary|Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase|A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.|From first dose to end of induction phase; up to 8 Weeks|All participants in the induction phase of the study|||Participants|||Number
1364171|NCT01636947|Secondary|Percentage of Participants With No Vomiting - Acute and Delayed Stages|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1, Day 2 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
1364172|NCT01636947|Secondary|Percentage of Participants With One or More Clinical Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event.|Day 1 through Day 29 (Up to 28 days after first dose of study drug)|All randomized participants who received chemotherapy and took ≥1 dose of study drug.|||Percentage of Participants|||Number
1364173|NCT01636947|Secondary|Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages|The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
1364174|NCT01636947|Secondary|Percentage of Participants With No Impact on Daily Life - Overall Stage|"The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, No Impact on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC."|Day 6|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug, had ≥1 post-treatment assessment on Day 1 and Day 2 and completed the FLIE questionnaire on Day 6.|||Percentage of Participants|||Number
1364175|NCT01636947|Secondary|Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage|"Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: How much nausea have you had over the last 24 hours? The left end of the scale (0 mm) was labeled no nausea, and the right end of the scale (100 mm) is labeled nausea as bad as it could be. In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm."|Days 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
1364176|NCT01636947|Secondary|Number of Emetic Events - Overall Stage|The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Number of Emetic Events|||Number
1364177|NCT01636947|Secondary|Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages|A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
1364178|NCT01636947|Primary|The Percentage of Participants With No Vomiting - Overall Stage|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The modified intention-to-treat (mITT) population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
1364179|NCT01636882|Primary|Safety|Participants with Grade 3 or Higher Adverse Events|12 months||||participants|||Number
1364180|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|FU Week 24|SP2 Population.|||Cm||Standard Deviation|Mean
1364181|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).|||Centimeters (cm)||Standard Deviation|Mean
1364182|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|FU Week 24|SP2 Population.|||Participants|||Number
1364183|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).|||Participants|||Number
1364184|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|FU Baseline and FU Week 24|SP2 Population.|||Participants|||Number
1364185|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal|SP1 Population.|||Participants|||Number
1364268|NCT01636258|Secondary|Diet - Daily Calorie Intake|Change in daily caloric intake as measured by online 24-hour recall dietary program|Baseline and final followup visit (at 8-14 weeks)||||Kcal/day||Inter-Quartile Range|Mean
1364186|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|FU Baseline and FU Week 24|SP2 Population.|||Participants|||Number
1364187|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal|SP2 Population.|||Participants|||Number
1364188|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24|SP1 Population.|||Participants|||Number
1364189|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population,|||Participants|||Number
1364190|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.|||Participants|||Number
1364191|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.|||Participants|||Number
1364192|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population.|||Participants|||Number
1364193|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.|||Participants|||Number
1364194|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.|||Participants|||Number
1364195|NCT01636778|Secondary|Mean BMI at the Indicated Time Points During Follow-up Period After Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population|||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
1364257|NCT01636453|Secondary|Number of Ipsilateral Ischemic Strokes|Defined as episodes of focal or global neurological dysfunction due to brain or retinal infarction in the same hemisphere of the target aneurysm with signs and symptoms that persist for 24 hours or longer. When appropriate, non contrast CT scans will be used to eliminate hemorrhagic strokes|At 12 months post-implant||||participants|||Number
1364196|NCT01636778|Secondary|Mean Change From Baseline in BMI at the Indicated Time Points in Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||kg/m^2||Standard Deviation|Mean
1364197|NCT01636778|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
1364198|NCT01636778|Secondary|Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2|The Body temperature of participants was recorded at the indicated time points..|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population|||Degrees centigrade||Standard Deviation|Mean
1364199|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||Degrees centigrade||Standard Deviation|Mean
1364200|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||Degrees centigrade||Standard Deviation|Mean
1364201|NCT01636778|Secondary|Mean Weight at the Indicated Time Points During Follow-up Period After Part 2|The weight of participants was recorded at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population|||kg||Standard Deviation|Mean
1364202|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 2|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||kg||Standard Deviation|Mean
1364203|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||Kilogram (kg)||Standard Deviation|Mean
1364204|NCT01636778|Secondary|Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2|The heart rate was measured in participants at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.|||bpm||Standard Deviation|Mean
1364205|NCT01636778|Secondary|Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2|The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline.|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||bpm||Standard Deviation|Mean
1364206|NCT01636778|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period|The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||Beats per minute (bpm)||Standard Deviation|Mean
1364207|NCT01636778|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.|||mmHg||Standard Deviation|Mean
1364208|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.|||mmHg||Standard Deviation|Mean
1364209|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period|Participant’s blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24|SP1|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1364223|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.|||Participants|||Number
1364258|NCT01636453|Primary|Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.||At 12 months post-implant||||Participants|||Count of Participants
1364210|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From FU Baseline up to FU Week 24 after Part 2|SP2 Population|||Participants|||Number
1364211|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Antiviral Baseline up to Week 48 in Part 2|Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.|||Participants|||Number
1364212|NCT01636778|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Baseline up to week 9 in Part 1|Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag.|||Participants|||Number
1364213|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2|FU Baseline, FU Week 12 and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis.|||Log international unit per milliliter||Standard Deviation|Mean
1364214|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points In Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal.|Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2|FAS2 Population.|||Log international unit per milliliter||Standard Deviation|Mean
1364215|NCT01636778|Secondary|Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2|ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1364216|NCT01636778|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1364217|NCT01636778|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1364218|NCT01636778|Secondary|Number of Participants With Sustained Virologic Response (SVR) in Part 2|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1364219|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.|||Participants|||Number
1364220|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.|||Participants|||Number
1364221|NCT01636778|Secondary|Number of Participants Achieving Adherence to Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1364222|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.|||Participants|||Number
1364226|NCT01636778|Secondary|Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1364227|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed.|||Participants|||Number
1364228|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed.|||Participants|||Number
1364229|NCT01636778|Secondary|Number of Antiviral Therapy Dose Reductions in Part 2|Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
1364230|NCT01636778|Secondary|Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy|Participants received eltrombopag at escalating dosages until a platelet count of >=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.|||Participants|||Number
1364231|NCT01636778|Secondary|Minimum Platelet Count on Antiviral Therapy|"Participants were assessed for platelet counts during antiviral therapy in Part 2.~Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|FAS2 Population: all participants enrolled in Part 2.|||Participants|||Number
1364232|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2|Platelet counts were measured by blood draw at specified timepoints.|Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis.|||Gi/L||Full Range|Median
1364233|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 2|Platelet counts were measured by blood draw|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|FAS2 Population.|||Gi/L||Full Range|Median
1364234|NCT01636778|Secondary|Time in Weeks to Achieve Platelet Count >= 100 Gi/L|Participants were assessed for achieving platelet counts >=100 Gi/L during Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.|||Participants|||Number
1364235|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 1|Platelet counts were measured by blood draw|Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1|FAS1 Population.|||10^9 Cells Per Liter (Gi/L)||Full Range|Median
1364236|NCT01636778|Primary|Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2|"Participants were assessed for continuously maintaining platelet counts >=50 Gi/L during Part 2.~Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2.|||Participants|||Number
1364237|NCT01636778|Primary|Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1|Participants were assessed for a shift from a baseline platelet count of <80 Gi/L to a count >=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1.|||Participants|||Number
1364238|NCT01636765|Primary|Intra-rater Reliability of the CEA Scale|Intra-rater (within raters) agreement of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 104 participant's severity of erythema of rosacea using the CEA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.|||Kappa statistics||95% Confidence Interval|Mean
1364252|NCT01636453|Secondary|Number of Intracranial Hemorrhages|Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the National Institutes of Health Stroke Scale (NIHSS) from baseline. The NIHSS ranges from 1 to 42, with higher scores indicating greater severity of stroke.|At 12 months post-implant||||Participants|||Count of Participants
1364239|NCT01636765|Primary|Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale|Inter-rater agreement (among raters) of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters scored 104 participant's severity of erythema due to rosacea using the CEA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kendall’s W was provided.|Day 1|All enrolled participants.|||Kendall's W||95% Confidence Interval|Mean
1364240|NCT01636713|Secondary|Change From Baseline Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 1|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated using the 0-6-hour post-dose FEV1 measurements collected on Day 1, which included pre-dose (30 minutes [min] and 5 min prior to dosing) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at Day 1was calculated as the WM at post -dose value on Day 1 minus Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1). Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 and 5 minutes pre-dose on Day 1), smoking status, and country/region.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1364241|NCT01636713|Secondary|Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score, smoking status, country/region, day, day by Baseline dyspnea index (BDI) focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1364242|NCT01636713|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, country/region, day, day by Baseline and day by treatment interactions. par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1364243|NCT01636661|Secondary|Hand Function Decline as Measured by Number of Participants|Measured by the Box and Blocks Test and Grip Strength|Baseline, Posttest, Follow-Up Session at One-Week||||participants|||Number
1364244|NCT01636661|Primary|Adverse Events/Safety Assessment.|"Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:~Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.~Physician Evaluation- Child identified as declining in function from pretest to posttest.~Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.~Detailed adverse events are reported in the adverse events module."|Baseline, Posttest, Follow-Up Session at One-Week|Pilot study therefore no sample size analysis. Completed per protocol.|||Participants|||Number
1364245|NCT01636466|Secondary|Incidence of Return to Dialysis Dependence||36 months|Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur.||||||
1364246|NCT01636466|Primary|Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)|Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI >5000 defined as positive|36 months|Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur.||||||
1364247|NCT01636453|Secondary|Number of Participants Who Experienced Aneurysm Recanalization||At 12 months post-implant||||Participants|||Count of Participants
1364248|NCT01636453|Secondary|Number of Participants Who Experienced Device Patency|Device patency (stenosis) at 12 months|at 12 months post-implant||||Participants|||Count of Participants
1364249|NCT01636453|Secondary|Number of Retreatments|Defined as any intervention after the completion of the initial stent assisted coiling procedure|At 12 months post-implant||||Participants|||Count of Participants
1364250|NCT01636453|Secondary|All Cause Mortality (Number of Deaths From Any Cause)||At 12 months post-implant||||Participants|||Count of Participants
1364271|NCT01636102|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 – Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1364272|NCT01636102|Primary|Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
1364273|NCT01636102|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
1364274|NCT01636102|Primary|Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1364275|NCT01636076|Secondary|Pharmacokinetic Parameter--AUC0-t|Area under the plasma concentration time curve from time zero to time “t” post-dose is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||hr*pg/mL||Standard Deviation|Mean
1364276|NCT01636076|Secondary|Pharmacokinetic Parameter--Tmax|Time to reach the maximum plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||Hr||Full Range|Median
1364277|NCT01636076|Secondary|Pharmacokinetic Parameter: Cmax|Maximum observed plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||pg/mL||Standard Deviation|Mean
1364278|NCT01636076|Secondary|Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint|Plasma indacaterol and mometasone furoate is to be measured in a subset of approximately 60 patients via central laboratory. Blood samples are collected at pre-dose on Day 1, 29, and 84; and post dose up to 4 hour on Day 1, up to 12 hours on Day 28 and 84. For sparse pharmacokinetic testing, blood samples will be collected at 23h 35 min post-dose following morning dose administration on Day 28 and 84, in all patients participating in this study.|Day 1, 29, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||pg/mL||Standard Deviation|Mean
1364279|NCT01636076|Secondary|Plasma Cortisol Concentrations at Each Timepoint|Plasma cortisol to be measured in a subset of approximately 60 patients via central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1, up to 12 hours post-dose on Day 28 and Day 84, and 23 hour 35 minute on Day 2, Day 29, and Day 85, and at pre-dose 25 minute on Day 28, and Day 84.|Day 1, Day 28, Day 84|Safety set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||nmol/mL||Standard Deviation|Mean
1364280|NCT01636076|Secondary|Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period|Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.|12 weeks|Full analysis set consisting of all randomized patients|||(Prednisolone dose equivalents) mg||Standard Deviation|Mean
1364281|NCT01636076|Secondary|The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||Percentage participants|||Number
1364282|NCT01636076|Secondary|Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||Days||Inter-Quartile Range|Median
1364586|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Off State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364283|NCT01636076|Secondary|Percentage of Patients With at Least One Exacerbation up to Week 12|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that had an exacerbation up to week 12. Less exacerbations reflect a better outcome.|12 weeks|Full analysis set consisting of all randomized patients|||Percentage of participants|||Number
1364284|NCT01636076|Secondary|Duration (in Days) of COPD Exacerbations|Duration and number of the COPD exacerbation will be analyzed by the negative binomial regression model including treatment, country, smoking status, and COPD severity as factors and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||Days||Standard Deviation|Mean
1364285|NCT01636076|Secondary|Annual Rate of COPD Exacerbations|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||COPD Exacerbations per year||95% Confidence Interval|Number
1364286|NCT01636076|Secondary|Time to First COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that were event free of a specified event.|12 weeks|Full analysis set consisting of all randomized patients|||Percentage of participants event free||95% Confidence Interval|Number
1364287|NCT01636076|Secondary|Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)|The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.|12 weeks|Full analysis set consisting of all randomized patients|||COPD exacerbation per participant||Standard Deviation|Mean
1364288|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale|The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.|Baseline, 4 and 12 weeks|Full analysis set.Higher scores show better outcomes.Excepting the sleep quantity subscale,scoring the MOS requires two steps:(a) assigning a point value to each response and (b) summing the point values for all the items in a given subscale or index. Each subscale and index score is then converted to a T score with a mean of 50 and an SD of 10.|||hours of sleep||Standard Deviation|Mean
1364289|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale|"Scoring the MOS Sleep Survey is a two-step process:• All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. For example, a score of 50 represents 50% of the highest possible score.~• Second, items within each scale are averaged together to create the 7 scale scores. Scales with at least one item answered can be used to generate a scale score. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scores represent the average for all items in the scale that the respondent answered. An additional measure is based on the average number of hours sleep each night during the past 4 weeks and are described in outcome measure 15."|Baseline, 4 and 12 weeks|Full analysis set.|||Units on a scale||Standard Deviation|Mean
1364290|NCT01636076|Secondary|Patient Reported Outcome Measures: COPD Assessment Test|It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.|Baseline, 4 and 12 weeks|Full analysis set consisting of all randomized patients|||Units on a scale||Standard Deviation|Mean
1364291|NCT01636076|Secondary|Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit|A TDI focal score of ≥1 is considered to be a clinically important improvement from baseline. Analysis of the proportion of subjects with a clinically important improvement of >=1 point in the TDI focal score, by visit|4 and 12 weeks|Full analysis set, All randomized patients. When data were missing or insufficient for any one of the domains a focal score could not be calculated.|||(%) showing clinical improvement|||Number
1364292|NCT01636076|Secondary|Patient Reported Outcome Measures: SGRQ (St. George’s Respiratory Questionnaire)|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|4 and 12 weeks|Full analysis set : At baseline all subjects with a baseline value are included. At each post-baseline day, only subjects with a value at both baseline and the respective day are included. Baseline SGRQ was completed on Day 1 prior to first dose.|||Total Score||Standard Deviation|Mean
1364293|NCT01636076|Secondary|The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .|This value represents the percent of days in the study where no rescue medication was needed.|Baseline to 12 weeks|Full analysis set consisting of all randomized patients|||% of days||Standard Error|Least Squares Mean
1364587|NCT01631825|Secondary|UPDRS Part 2 Sum Score (On State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364294|NCT01636076|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist)|Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.|12 weeks|Full analysis set consisting of all randomized patients|||Number of puffs||Standard Error|Least Squares Mean
1364295|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min – 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 28, Day 84|Peak FEV1 was calculated for all subjects in the FAS at Day 1 (Visit 201) and was calculated for all subjects in the 24-h profiling subset of the FAS at Day 1 (Visit 201), Day 28 (Visit 203) and Day 84 (Visit 205).|||Liters*hours||Standard Error|Least Squares Mean
1364296|NCT01636076|Secondary|FEV1 AUC (5 Min-4 h),|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 1(Baseline), Day 28, Day 84|24 hr profiling subgroup|||Liters*hours||Standard Error|Least Squares Mean
1364297|NCT01636076|Secondary|FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min – 4h)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), Scheduled (not actual) time points are to be used. The standardized AUC(5 min – 4 h) for FEV1 will be summarized by treatment.|Day 1|Full analysis set consisting of all randomized patients|||Liters * hours||Standard Error|Least Squares Mean
1364298|NCT01636076|Secondary|FEV1/FVC at Each Timepoint|Spirometry is conducted according to the global standard. FEV1/FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients|||FEV1/ FVC (%)||Standard Deviation|Mean
1364299|NCT01636076|Secondary|Forced Vital Capacity (FVC) at Each Timepoint|Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients|||liters||Standard Deviation|Mean
1364300|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint||Day 1 through day 85|Full analysis set consisting of all randomized patients|||liter||Standard Error|Least Squares Mean
1364301|NCT01636076|Secondary|Trough FEV1 After First Dose and After 4 Weeks of Treatment|Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 1 hours on Day 1 and Day 28; 24 hours post-dose on Day 29 and 85. In a subset of approximately 60 patients, FEV1 is measured up to 20 hours postdose on Day 28 and Day 84.|Day 1 and Day 85|All randomized patients were included in the Safety analysis set (SAF) and Full analysis set (FAS).|||Liters||Standard Error|Mean
1364302|NCT01636076|Primary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85|Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.|12 weeks|All randomized patients were included in the Full analysis set (FAS)|||Liters||Standard Error|Least Squares Mean
1364303|NCT01636063|Primary|Initial Cervical Dilation at the Time of Surgical Abortion|Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.|24 to 48 hours after enrollment||||French units||Standard Deviation|Mean
1364304|NCT01635933|Secondary|Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)|Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where ‘study lenses’ refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.|Day 28|The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values.|||Percentage of participants|||Number
1364305|NCT01635933|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.|||Units on a scale||Standard Deviation|Mean
1364306|NCT01635933|Primary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.|||Units on a scale||Standard Deviation|Mean
1365020|NCT01626092|Primary|Donor (Allogeneic) Hematopoietic Engraftment|Number of patients who achieve hematopoietic engraftment - assessment of nucleated peripheral blood cells for donor (allogeneic) chimerism following this reduced-intensity HCT.|Day 100 Following Hematopoietic Cell Transplant (HCT)||||participants|||Number
1364307|NCT01635920|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1364308|NCT01635920|Primary|Percentage of Subjects With Same Fit in Both Eyes|"Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. Same fit was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit."|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.|||percentage of participants|||Number
1364309|NCT01635881|Secondary|In-hospital Major Adverse Cardiac Events (MACE)|"In-hospital MACE:~All death (cardiac and non-cardiac)~Myocardial infarction (MI)~Target Vessel Revascularization (TVR)~In-hospital Stent Thrombosis (ST) within the target vessel~Clinically significant arrhythmias (requiring intervention)"|Participants will be followed for the duration of hospital stay (an expected average of 24 hours)|Analysis population consists of intent-to-treat subject population.|||percentage of participants||95% Confidence Interval|Number
1364310|NCT01635881|Primary|Device Procedural Success|"Device procedural success consisting of the following:~Successful delivery, inflation, deflation and withdrawal of the study balloon.~No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon.~Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure"|Peri-procedural|Analysis population consists of intent-to-treat subject population.|||percentage of participants||95% Confidence Interval|Number
1364311|NCT01635855|Primary|Rate of Severe Common Adverse Events|The purpose of this study was to determine if the rate of “Severe” common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies).“Common” is defined as pre-specified adverse events occurring in >= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration.|1 month||||percentage of 'severe' common AEs||95% Confidence Interval|Number
1364312|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.|||percentage of participants|||Number
1364313|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.|||percentage of participants|||Number
1364314|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.|||percentage of participants|||Number
1364321|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.|||percentage of participants|||Number
1364315|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point|||percentage of participants|||Number
1364316|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point|||percentage of participants|||Number
1364317|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point|||percentage of participants|||Number
1364318|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.|||units on a scale||Standard Deviation|Mean
1364319|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.|||units on a scale||Standard Deviation|Mean
1364320|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.|||units on a scale||Standard Deviation|Mean
1365021|NCT01625910|Secondary|Sugar Sweetened Beverages|Change in reported intake of sugar sweetened beverages|Three months|Intention to treat analysis|||cans per day||Standard Error|Mean
1364322|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.|||percentage of participants|||Number
1364323|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.|||percentage of participants|||Number
1364324|NCT01635764|Primary|Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.|||percentage of participants|||Number
1364325|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.|||percentage of participants|||Number
1364326|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.|||percentage of participants|||Number
1364327|NCT01635504|Primary|Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks||||percentage reduction in parotid volume||Full Range|Mean
1364328|NCT01635504|Primary|Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks||||percentage reduction in masseter volume||Full Range|Mean
1364329|NCT01635439|Secondary|Normal Vaginal Delivery Rate||24 hours||||participants|||Number
1364330|NCT01635439|Secondary|Need for Syntocinon Augmentation||24 hours||||participants|||Number
1364331|NCT01635439|Secondary|Uterine Hyper-stimulation Rate||24 hours||||participants|||Number
1364332|NCT01635439|Secondary|Induction to Onset of Labor Interval||24 hours||||hours||Standard Deviation|Mean
1364333|NCT01635439|Primary|Induction to Delivery Interval||24 hours||||hours||Standard Deviation|Mean
1364334|NCT01635244|Primary|Aortic Valve Mean Gradient (mm Hg) at Peak Exercise|This is a measure of the resistance to flow across the aortic bioprosthesis.|6 months after aortic valve replacement||||mm Hg||Inter-Quartile Range|Median
1364335|NCT01635218|Secondary|Remission Rates at 6 Weeks|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score < 7 points after 6 weeks of treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.|||participants with a score of < 7 in HS|||Number
1364336|NCT01635218|Secondary|Change From Baseline in Greene´s Scale at 6 Weeks.|Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and > 50 (severe symptoms).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.|||Units in Green Scale||Standard Deviation|Mean
1364353|NCT01634620|Primary|Mean FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population|||parts per billion (ppb)||Standard Deviation|Mean
1364337|NCT01635218|Secondary|Responder Rates at 6 Weeks.|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.|||participants with a decrease >50% in HS|||Number
1364338|NCT01635218|Secondary|Change From Baseline in Beck Depression Inventory at 6 Weeks.|Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), > 29 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.|||Units in Beck Depression Inventory||Standard Deviation|Mean
1364339|NCT01635218|Primary|Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.|17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented in outcome measure data table are the final scores in Hamilton Scale after 6 weeks of treatment.|||Units in Hamilton Scale||Standard Deviation|Mean
1364340|NCT01635062|Secondary|Change in Urine Protein After Calcitriol/Placebo Therapy|Subjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo.|baseline and 3 weeks following calcitriol/placebo therapy||||mg/24h||Standard Deviation|Mean
1364341|NCT01635062|Secondary|Change in Renal Plasma Flow After Calcitriol/Placebo Therapy|Subjects had their renal plasma flow assessed at baseline while sodium loaded, and again after 3 weeks of randomized therapy with either calcitriol (up to 0.75 mcg daily) or placebo.|baseline and 3 weeks following calcitriol/placebo therapy||||mL/min/1.73m2||Standard Deviation|Mean
1364342|NCT01635062|Primary|The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy|The below results represent the change in Plasma Renin Activity.|baseline and 2 weeks following calcitriol/placebo therapy||||ng/mL/h||Inter-Quartile Range|Median
1364343|NCT01634854|Secondary|NICU Admission and APGAR Less Than 7 at 5 Minutes|NICU admission and APGAR less than 7 at 5 minutes|Through discharge from hospital||||Participants|||Count of Participants
1364344|NCT01634854|Secondary|Number of Participants With Excessive Uterine Activity Necessitating Treatment|Number of patients receiving terbutaline during labor for uterine tachysytole|Measured from initiation of medication until delivery time||||Participants|||Count of Participants
1364345|NCT01634854|Secondary|Maternal Satisfaction With Labor||6 weeks post-partum|data was not collected||||||
1364346|NCT01634854|Secondary|Maternal Delivery Outcomes|Maternal delivery outcomes|Through discharge from hospital||||Participants|||Count of Participants
1364347|NCT01634854|Secondary|Neonatal Weight at Delivery|Neonatal Weight|Immediately following delivery||||grams||Inter-Quartile Range|Median
1364348|NCT01634854|Secondary|Neonatal APGAR Scores|APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.|At 1 minute and 5 minutes after delivery||||number||Inter-Quartile Range|Median
1364349|NCT01634854|Primary|Time From Induction to Vaginal Delivery|Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.|Time to delivery in minutes from initiation of medication, up to 24 hours||||minutes||Inter-Quartile Range|Median
1364350|NCT01634659|Secondary|End of Day Comfort|End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
1364351|NCT01634659|Secondary|Overall Quality of Vision|Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
1364352|NCT01634659|Primary|Overall Comfort|Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
1364354|NCT01634620|Primary|FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population|||participants|||Number
1364355|NCT01634620|Primary|FeNO Levels by Smoking Status|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit.|Single Visit||||participants|||Number
1364356|NCT01634620|Primary|FeNO Levels by Inhaled Corticosteroid Use|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit.|Single Visit|Per-protocol Population|||participants|||Number
1364357|NCT01634620|Primary|FeNO Levels by GOLD Stage of Severity|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category.|Single Visit|Per-protocol Population|||parts per billion (ppb)||Standard Deviation|Mean
1364358|NCT01634620|Primary|Spirometry Results: PEF (L/Min)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters per minute||Standard Deviation|Mean
1364359|NCT01634620|Primary|Spirometry Results: FEF25-75 (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters per second||Standard Deviation|Mean
1364360|NCT01634620|Primary|Spirometry Results: FEF50% (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters per second||Standard Deviation|Mean
1364361|NCT01634620|Primary|Spirometry Results: FEV1 (% Predicted)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Percent Predicted||Standard Deviation|Mean
1364362|NCT01634620|Primary|Spirometry Results: FVC (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters||Standard Deviation|Mean
1364363|NCT01634620|Primary|Spirometry Results: FEV1 (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters||Standard Deviation|Mean
1364364|NCT01634555|Secondary|Development of Antibodies Against Ramucirumab||Prior to ramucirumab infusion in Cycle 2, Day 1, End of treatment, and 30-day follow-up||2019-02-28|02/2019||||
1364365|NCT01634555|Secondary|Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)||Cycle 2: -2, -1, -0.5, 0, 2, 3, 4, 5, 8, 10, 25, 48, 72, 96, 168, 264, 336 hours post-ramucirumab (IMC-1121B) infusion|All participants who received study drug and had sufficient concentration data to calculate ramucirumab (IMC-1121B) Cmax in Cycle 2.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1364366|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 2.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1364367|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 1.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1364368|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 2.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1364369|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 1.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1364370|NCT01634360|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|"Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56.~ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor."|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population|||Scores on scale||Standard Deviation|Mean
1364371|NCT01634360|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population|||Hours||Standard Deviation|Mean
1364372|NCT01634360|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made.|||Hours||Standard Deviation|Mean
1364373|NCT01634256|Secondary|Changes in Serum Bilirubin|serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
1364374|NCT01634256|Secondary|Changes in γ-GT(Gamma-Glutamyl Transferase)|γ-GT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
1364375|NCT01634256|Secondary|Changes in ALP(Alkaline Phosphatase)|ALP was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
1364376|NCT01634256|Secondary|Changes in AST(Aspartate Transaminase)|AST was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
1364377|NCT01634256|Primary|Changes in ALT(Alanine Transaminase)|ALT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
1364378|NCT01634243|Secondary|Off Time for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing|Subjects with measurable off time data at baseline and after dosing, LOCF|||Hours||Standard Deviation|Mean
1364379|NCT01634243|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
1364380|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
1364381|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
1364382|NCT01634243|Secondary|UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
1364383|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
1364384|NCT01634243|Secondary|UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
1364385|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
1364386|NCT01634243|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum at 12 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1364387|NCT01634243|Secondary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|Incidence and severity of adverse events, vital signs, and laboratory parameters following the initiation of study treatment.|Up to 12 weeks after dosing|Safety analysis set|||participants|||Number
1364388|NCT01634243|Primary|Maintenance Dose of the SPM962|The maintenance dose of the SPM 962 was examined based on the safety and efficacy.|Up to 12 weeks after dosing|Subjects in the safety analysis set who entered the maintenance period|||participants|||Number
1364389|NCT01634165|Secondary|Total Amount of Glucose Infused (Gtot)|Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Gtot measurements. Participants were analyzed based on the treatment they received.|||milligrams per kilograms (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1364390|NCT01634165|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Rmax measurements. Participants were analyzed based on the treatment they received.|||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
1364391|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-tlast). Participants were analyzed based on the treatment they received.|||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1364392|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.|||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1364393|NCT01634165|Primary|Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)||Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.|||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1364581|NCT01631825|Secondary|Each Item of UPDRS Part 2 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
1364394|NCT01634165|Primary|Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]|Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.|||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1364395|NCT01634152|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at week 12.~A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary and no use of rescue medication reported via the eDiary during that day.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Days||Standard Error|Mean
1364396|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at week 12.~Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364397|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at week 12.~Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364398|NCT01634152|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at week 12.~Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364399|NCT01634152|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at week 12.~Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364400|NCT01634152|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at week 12.~Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364401|NCT01634152|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at week 12.~Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364402|NCT01634152|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364403|NCT01634152|Secondary|FEV1 a.m. Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364404|NCT01634152|Secondary|Peak Expiratory Flow (PEF) Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Percentage of PEF||Standard Error|Mean
1364405|NCT01634152|Secondary|Peak Expiratory Flow (PEF) p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||L/min||Standard Error|Mean
1364406|NCT01634152|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||L/min||Standard Error|Mean
1364582|NCT01631825|Secondary|Each Item of UPDRS Part 1|The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
1364407|NCT01634152|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.~Measured values presented are actually adjusted means"|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1364408|NCT01634152|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1364409|NCT01634152|Secondary|Use of PRN Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at week 12.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1364410|NCT01634152|Secondary|ACQ-IA Total Score Responders|"Responder categories based on the ACQ-IA total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ-IA total score responders.~The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.|||Percentage of participants|||Number
1364411|NCT01634152|Secondary|Control of Asthma as Assessed by ACQ-IA Total Score|"Change from baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) total score measured at week 12.~The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364412|NCT01634152|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline at each individual timepoint.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364413|NCT01634152|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364414|NCT01634152|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364415|NCT01634152|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364416|NCT01634152|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364417|NCT01634152|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 12 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364418|NCT01634152|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364419|NCT01634152|Primary|FEV1 Peak(0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364420|NCT01634139|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at weeks 24 and 48.~A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary (electronic diary) and no use of rescue medication reported via the eDiary during that day.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Days||Standard Error|Mean
1364421|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at weeks 24 and 48.~Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364422|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at weeks 24 and 48.~Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364423|NCT01634139|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at weeks 24 and 48.~Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364424|NCT01634139|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at weeks 24 and 48.~Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364425|NCT01634139|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at weeks 24 and 48.~Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364426|NCT01634139|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at weeks 24 and 48.~Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
1364427|NCT01634139|Secondary|Responders in PAQLQ(S) at Weeks 24 and 48|"Responders in PAQLQ(S) at weeks 24 and 48. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≥0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≤-0.5). No statistical testing was performed for PAQLQ(S) total score responders.~The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control)."|Weeks 24 and 48.|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.|||Patients|||Number
1364428|NCT01634139|Secondary|PAQLQ(S) Emotional Function Domain Score|"PAQLQ(S) emotional function domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
1364429|NCT01634139|Secondary|PAQLQ(S) Activity Limitation Domain Score|"PAQLQ(S) activity limitation domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
1364430|NCT01634139|Secondary|PAQLQ(S) Symptom Domain Score|"PAQLQ(S) symptom domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score was calculated as the mean of the items in the domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
1364431|NCT01634139|Secondary|PAQLQ(S) Total Score|"Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) total score at weeks 24 and 48.~The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). Total Score is calculated as mean of all 23 questions.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
1364432|NCT01634139|Secondary|ACQ−IA Responder Analysis|"Responder categories based on the ACQ-IA total score after 24 and 48 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5). No statistical testing was performed for ACQ-IA total score responders.~The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Weeks 24 and 48|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason|||Patients|||Number
1364433|NCT01634139|Secondary|ACQ−IA Total Score|"Interviewer Administered Asthma Control Questionnaire (ACQ-IA) total score after 24 and 48 weeks of treatment.~The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
1364434|NCT01634139|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364435|NCT01634139|Secondary|FEV1 a.m Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 24 and 48.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1364436|NCT01634139|Secondary|PEF Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Percentage of PEF||Standard Error|Mean
1364437|NCT01634139|Secondary|PEF p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres per min (L/min)||Standard Error|Mean
1364438|NCT01634139|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres per min (L/min)||Standard Error|Mean
1364439|NCT01634139|Secondary|Use of PRN Rescue Medication During Nighttime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during nighttime based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1364440|NCT01634139|Secondary|Use of PRN Rescue Medication During Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during daytime based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1364441|NCT01634139|Secondary|Use of PRN (Pro re Nata) Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at weeks 24 and 48.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1364442|NCT01634139|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline to week 24 at each individual timepoint.~The measured values presented are actually adjusted means~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at Week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364443|NCT01634139|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364444|NCT01634139|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364445|NCT01634139|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 24 and 48 Weeks of treatment.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364446|NCT01634139|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"FEV1 change from baseline to week 24 at each individual timepoint.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364447|NCT01634139|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364448|NCT01634139|Secondary|FEV1 Peak (0-3h) at Week 48 Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and Week 48.|FAS. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1365813|NCT01613417|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population|||signal intensity|Participants|Standard Deviation|Mean
1364449|NCT01634139|Secondary|Trough FEV1 Change From Baseline|"Change from Baseline in Trough (pre-dose) Forced Expiratory Volume (FEV) in 1 second (FEV1) measured at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N’s for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364450|NCT01634139|Primary|FEV1 Peak (0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 24.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 24 Weeks.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
1364451|NCT01634113|Secondary|Individual FVC Measurements|Change from baseline in individual FVC measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364452|NCT01634113|Secondary|Individual FEV1 Measurements|Change from baseline in individual FEV1 measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364453|NCT01634113|Secondary|FVC AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364454|NCT01634113|Secondary|Trough FVC Change From Baseline|Change from baseline of trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 12 weeks of treatment.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364455|NCT01634113|Secondary|FVC Peak (0-3h) Change From Baseline|Change from baseline in maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak (0–3h)) after 12 weeks of treatment.|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364456|NCT01634113|Secondary|FEV1 AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364457|NCT01634113|Secondary|Trough FEV1 Change From Baseline|Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364458|NCT01634113|Secondary|Weekly Mean Nighttime Awakenings Due to Asthma Symptoms|"Change from baseline in the weekly mean nighttime awakenings due to asthma symptoms as assessed by the PACD, in the last week of the 12 week treatment period.~The weekly mean was calculated as the average of the weekly scores for the question “Did your child wake up during the night due to his/her asthma?” The question was answered on a 5-point verbal rating scale, with scores ranging from 1 (did not wake up) to 5 (was awake all night). A week was defined as 7 days.~The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||units on a scale||Standard Error|Mean
1364459|NCT01634113|Secondary|Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication|Weekly percentage of days with use of salbutamol (albuterol) rescue medication at week 12. A week was defined as 7 days.|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||percentage of days||Standard Deviation|Mean
1364460|NCT01634113|Secondary|Weekly Percentage of Days Without Asthma Symptoms|"Weekly Percentage of days without asthma symptoms at week 12.~A day without asthma symptoms was defined as a day during which the patient experienced no asthma symptoms, did not use rescue medication (salbutamol/albuterol) and had no asthma exacerbation/worsening requiring systemic corticosteroids, or unscheduled visits to a doctor’s office, emergency department, or hospital. A week was defined as 7 days.~The measured values presented are adjusted means"|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||percentage of days||Standard Error|Mean
1364880|NCT01628107|Secondary|Mean Hemoglobin Levels: Over Week 1 to 48||Week 1 up to Week 48|"FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||g/dL||Standard Deviation|Mean
1364461|NCT01634113|Secondary|Weekly Mean Overnight Asthma Symptom Score Response|"Change from baseline in the weekly mean overnight asthma symptom score response as assessed by the PACD in the last week of the 12 week treatment period.~The overnight score is the score from the following question in the PACD, How much did your child cough last night after your child was put to bed for the night until he/she awoke this morning?. This endpoint was determined only for patients with 2 or more nights with symptoms per week during the baseline period. In this case, the baseline period is the 7 days used to derive the baseline value. A patient has a night with symptoms if the question was answered with scores 1, 2, 3, 4 or 5 or the patient received β-Agonist at least one time since he/she went to bed. A week was defined as 7 days.~Scores range from 0 (best) to 4 (worst), a value of 5 indicates severity of symptoms is unknown.~The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||units on a scale||Standard Error|Mean
1364462|NCT01634113|Primary|FEV1 Peak (0-3h) Change From Baseline|Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
1364463|NCT01634113|Primary|Weekly Mean Combined Daytime Asthma Symptom Score|"Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period.~The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days.~The combined daytime score is the average of scores from questions 4 – 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst).~The measured values presented are adjusted means."|Baseline and 12 weeks|Full analysis set, which included all randomised patients who received at least one dose of trial medication, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||units on a scale||Standard Error|Mean
1364464|NCT01634100|Secondary|Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1364465|NCT01634100|Primary|Total Empa: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total empa in plasma, per period.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1364466|NCT01634100|Primary|Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1364467|NCT01633944|Secondary|Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with MOS assessment at week 12 (n=199 buprenorphine and n=194 placebo).|||units on a scale||Standard Deviation|Mean
1364468|NCT01633944|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with RMDQ assessment at week 12 (n=193 buprenorphine and n=189 placebo).|||units on a scale||Standard Deviation|Mean
1364881|NCT01628107|Secondary|Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||U/kg/week||Standard Deviation|Mean
1364469|NCT01633944|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (41). Includes only participants with PGIC assessment at week 12 (n=198 buprenorphine and n=194 placebo).|||units on a scale||Standard Deviation|Mean
1364470|NCT01633944|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||percentage of participants|||Number
1364471|NCT01633944|Secondary|Time to Optimal Dose of Open-label Study Medication|Overall time to reach the “optimal” dose of study medication required to progress to double-blind treatment.|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment.|||days||Standard Deviation|Mean
1364472|NCT01633944|Secondary|Number of Subjects With Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary.|Week 1 to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||participants|||Number
1364473|NCT01633944|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||participants|||Number
1364474|NCT01633944|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||units on a scale||Standard Deviation|Mean
1364475|NCT01633892|Secondary|Characterization of Adipose Stromal Cell (ASC) Function|Cell assessment will include viable stromal vascular fraction per gram of lipoaspirate.|time of surgery, up to 12 hours post-baseline||||mL of viable SVF per g of lipoaspirate||Standard Deviation|Mean
1364476|NCT01633892|Secondary|Composition of SVF|Cell assessment included stromal vascular fraction composition evaluated by flow cytometry.|time of fat grafting, up to 12 hours post-baseline||||percentage of cells||Standard Deviation|Mean
1364477|NCT01633892|Secondary|Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.|"1) Social Avoidance and Distress Scale (SADS) uses a questionnaire including 28 true/false items, with scores ranging from 0-10. A low score is below 4, high is above 7; intermediate is between 4-7. 2) COPE scale asks the subject to indicate what he/she generally does and feels, when he/she experience stressful events. On a scale of 60-240 where the higher ends indicates the subject does this activity most frequently during stressful events; 3) The Satisfaction With Appearance Scale (SWAP) is a 14-item questionnaire, assessing both the subjective appraisal and social-behavioral components of body image, where the higher the score, the more satisfied subject is with procedure, ranging from 0-7 for a total possible score range between 0-98 ."|9 months||||units on a scale, see outcome measure de||Standard Deviation|Mean
1364478|NCT01633892|Primary|Average Tissue Thickness From Baseline up to 9 Months|High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months|0, 1, 3, and 9 months||||mm||Standard Deviation|Mean
1364479|NCT01633892|Primary|Average Fat Graft Volume Facial Form From Baseline up to 9 Months|High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months|0, 1, 3, and 9 months||||cc||Standard Deviation|Mean
1364480|NCT01633853|Primary|The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.|The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.|24 months||||pg/ml||Standard Deviation|Mean
1364481|NCT01633853|Primary|The Blood Levels of Phosphorus at the 24th Month of Following up.|The blood levels of phosphorus at the 24th month of following up will be detected.|24 months||||mmol/L||Standard Deviation|Mean
1364482|NCT01633853|Secondary|The Incidence Rate of Secondary Hyperparathyroidism.|Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups.|24 months||||participants|||Number
1364483|NCT01633853|Secondary|The Blood 25(OH)Vitamin D Level.|The levels of blood 25(OH)Vitamin D at the 24th month of following up.|24 months||||ng/ml||Standard Deviation|Mean
1364484|NCT01633853|Primary|The Blood Levels of Calcium at the 24th Month of Following up.|The blood levels of calcium at the 24th month of following up will be detected.|24 months||||mmol/L||Standard Deviation|Mean
1364584|NCT01631825|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score.~A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364485|NCT01633827|Secondary|Apnea-Hypopnea Index|The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||events/hr||Standard Error|Mean
1364486|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Active Collapsibility (Vactive)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.~Active collapsibility is the ventilation on no CPAP when upper airway muscle are maximally activated. It is calculated by slowing reducing CPAP from the optimal to the minimum tolerable level and rapidly dropping the CPAP to 0 for a few breaths. This trait is symbolized as Vactive (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||L/min||Standard Error|Mean
1364487|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Passive Collapsibility|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.~The passive collapsibility of the upper airway is quantified as the ventilation on no CPAP (atmospheric pressure) at the eupneic level of ventilatory drive when upper airway dilator muscles are relatively passive. This trait is symbolized as Vpassive (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||L/min||Standard Error|Mean
1364488|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Ventilatory Control Sensitivity (Loop Gain)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.~In this table the investigators report the ventilatory control sensitivity value (Loop Gain). It is calculated dividing the increase in ventilatory drive by the steady state reduction in ventilation. The increase in ventilatory drive is measured as the ventilatory overshoot following a switch to optimal CPAP from the minimum tolerable CPAP. This trait is symbolized as steady state loop gain (LG, adimensional)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||ratio, adimensional||Standard Error|Mean
1364489|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Ventilation That Causes an Arousal From Sleep (Varousal)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual.~In this table the investigators report the minimum ventilation that can be tolerated before an arousal from sleep (Varousal). It is calculated by slowly reducing the CPAP level from optimum to the minimum tolerable pressure. This trait is symbolized as Varousal (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||L/min||Standard Error|Mean
1364490|NCT01633814|Primary|Change in Exercise Pressor Reflex Responsiveness (Mean Blood Pressure Response (mmHg) and Muscle Sympathetic Nerve Activity Response (Burst Frequency) During Post Handgrip Ischemia.)|To estimate exercise pressor reflex responsiveness changes in blood pressure and muscle sympathetic nerve activity from rest to during a period of post handgrip ischemia will be used.|Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.|Results are not available due to all members of the study having left the institution and not having made results available.||||||
1364491|NCT01633814|Primary|Change in Carotid Baroreflex Sensitivity (Bpm/mmHg)|Carotid baroreflex sensitivity will be measured using the application of neck pressure and neck suction. Briefly, a variable neck pressure collar will be placed around the anterior two thirds of the neck to change carotid sinus transmural pressure.|Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.|Results are not available due to all members of the study having left the institution and not having made results available.||||||
1364492|NCT01633788|Secondary|Percentage of Complete Overall Ocular Discomfort Responders|Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit.|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point|||Percentage of Patients|||Number
1364942|NCT01627561|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)||||Subjects|||Number
1364493|NCT01633788|Secondary|Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye|The MQS is assessed based on Mathers’ meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit.|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point|||Percentage of Patients|||Number
1364494|NCT01633788|Primary|Percentage of Meibum Quality Responders in the Study Eye|Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers’ meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point|||Percentage of Patients|||Number
1364495|NCT01633320|Primary|Pain Scores on a 0-10 Numeric Rating Scale (NRS)|Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain|At arrival in PACU or 10 min after extubation||||units on a scale||Standard Deviation|Mean
1364496|NCT01633320|Primary|Analgesia/Nociception Index (ANI)|The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.|At arrival in post-operative care unit (PACU) or 10 min after extubation||||units on a scale||Standard Deviation|Mean
1364497|NCT01632995|Secondary|Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected||Participants were followed for 48 weeks, or up to the point of early termination||||participant with acquired HIV resistance|||Number
1364498|NCT01632995|Secondary|Number of Participants Who Seroconvert||Participants were followed for 48 weeks, or up to the point of early termination||||participants|||Number
1364499|NCT01632995|Primary|Measurement of PrEP Adherence by Medication Possession Ratio|Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits|Participants were followed for 48 weeks, or up to the point of early termination|Mean PrEP adherence by medication possession ratio|||percent|||Number
1364500|NCT01632995|Primary|Number of Male Sexual Partners||Participants were followed for 48 weeks, or up to the point of early termination||||partners||Full Range|Mean
1364501|NCT01632995|Primary|Measurement of PrEP Adherence by TFV-DP Levels in DBS||Participants were followed for 48 weeks, or up to the point of early termination|DBS testing was performed in approximately 100 randomly selected participants per site, and among all African American and transgender participants, who were underrepresented in the overall sample|||Percent of Participants|||Number
1364502|NCT01632995|Primary|Measurement of Side Effects/Toxicities||Participants were followed for 48 weeks, or up to the point of early termination||||events|||Number
1364503|NCT01632995|Primary|Duration of PrEP Use|Mean duration of interruptions|Participants were followed for 48 weeks, or up to the point of early termination||||Days|||Number
1364504|NCT01632995|Primary|Duration of PrEP Use|Number of study drug interruptions|Participants were followed for 48 weeks, or up to the point of early termination||||interruptions|||Number
1364505|NCT01632995|Primary|Measurement of Refusal Rate of PrEP||Measured through enrollment (Week 0)||||Participants|||Count of Participants
1364506|NCT01632995|Primary|Measurement of Acceptance Rate of PrEP||Measured through enrollment (Week 0)||||Participants|||Count of Participants
1364507|NCT01632904|Secondary|Proportion of Subjects Randomized to Ruxolitinib Who Achieved ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine and the Individual Symptom Scores at Week 16 That Were Maintained at Week 48|Durable Response on TSS-C/individual symptoms defined as a ≥ 50% reduction in TSS-C/individual symptoms at Week 16 that were maintained at Week 48|Week 48|Intent-to-Treat (ITT); all subjects randomized to Ruxolitinib in the study. For TSS-C/individual symptoms, subject without baseline value was excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
1364508|NCT01632904|Secondary|Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16|The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For individual symptom scores within the TSS-C cluster, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.|||Percentage of participants|||Number
1364509|NCT01632904|Primary|Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary|Symptoms of polycythemia vera were assessed using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) electronic diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): tiredness, itching, muscle aches, night sweats, and sweats while awake. The total symptom score ranged from 0-50 and was calculated as the sum of the 5 symptom scores. A higher score indicates worse symptoms.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For the overall TSS-C score, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.|||Percentage of participants|||Number
1364510|NCT01632878|Primary|Number of Occurrences of Cardio-vascular Events|Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)|12 months||||events|||Number
1364511|NCT01632800|Primary|Degree of Discomfort Under Applied Pulsed Magnetic Fields|Pulsed magnetic fields will be applied a total of forty-eight times to the right hand of each subject. After each time the magnet coil is pulsed, the subject will be asked if he or she notices any sensation (for example, tingling or tapping). Subjects will be asked to rate the sensation from 0 to 4, where 0 means no sensation, 1 means barely-noticeable sensation, 2 means easily noticeable sensation, 3 means unpleasant sensation, and 4 means very unpleasant sensation.|Bioeffects will be assessed within the five-minute application of each pulse sequence||||percentage of subjects with discomfort|||Number
1364512|NCT01632735|Secondary|Social Support Utilization|"Self-help utilization was measured by the question: In the past 30 days, how many days did you attend self-help meetings like AA or NA to support your recovery?”"|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|Intent to treat model was used to assess the effects of the intervention (mobile continuing care) compared to aftercare as usual in terms of improvements in social support service utilization over time (baseline, discharge and follow-ups: 3-, 6- and 9-months post-discharge).|||days per month||Standard Deviation|Mean
1364513|NCT01632735|Secondary|Recovery Confidence (Self-efficacy) Over Time|"Change/improvements in mean recovery confidence score over time (measured by question How confident are you in your ability to be completely abstinent (clean) from alcohol and drugs in the next 30 days? (units on scale included 0=not at all, 1=slightly, 2=moderately, 3=considerably, 4-extremely)."|baseline, discharge, 3-, 6-, and 9-month follow-ups|Used an intent to treat design. Examined the effects of the intervention (mobile continuing care) compared to aftercare as usual on change in recovery self-confidence over time.|||units on a scale||Standard Deviation|Mean
1364514|NCT01632735|Secondary|Participation in Recovery Behaviors Over Time|Recovery behaviors defined as mean number of days doing extracurricular/recovery-goal directed activities using repeated measures over time.|baseline, discharge, 3-, 6- and 9-month follow-ups|Intent to treatment model was used. Mixed modeling used to examine differences in recovery behaviors (measured by mean days doing extracurricular/recovery-goal directed activities) over time between study conditions.|||days per month||Standard Deviation|Mean
1364515|NCT01632735|Primary|Primary Substance Use (Defined as Substance Received Treatment for)|Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|An intent to treat model was used. The primary outcome measure is primary substance use measured by urine drug test at baseline, discharge as well as at 3-, 6-, and 9-month follow-ups. Study retention at discharge was 95%, 92.5% at 3 months, 86.2% at 6 months, and 82.5% at 9 months.|||percentage of positive urines|||Number
1364516|NCT01632709|Secondary|Pain Visual Analogue Scale (VAS)|The Pain Visual Analogue Scale (VAS) is a scale from 0-100 where 0= no pain and 100=the worst pain|VAS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
1364517|NCT01632709|Secondary|Change in Depression (CES-D 10)|The Center for Epidemiologic Studies Short Depression Scale (CES‐D 10) is a validated instrument that assesses depression. The CES-D 10 is a scale from 0-30 where 0= no depression and 30=the most depression|CES-D 10 collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
1364518|NCT01632709|Secondary|Change in Perceived Anxiety (PASS)|The Pain Anxitey Symptoms Scale (PASS) is a validated instrument that assesses anxiety in.The PASS is a scale from 0-100 where 0= no anxiety and 100=the most anxiety|PASS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
1364519|NCT01632709|Secondary|Change in Perceived Disability (PDI)|The PDI is a seven-item validated instrument that assesses perceived disability in 7 key life areas. The Pain Disability Scale is a scale from 0-70 where 0= no disability and 70=the most disability|PDI collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
1364520|NCT01632709|Primary|Change in Pain|Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable)|Pain rating before and at 15 minutes and 1 hour post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
1364521|NCT01632683|Secondary|Number of Participants With Observed Complications|Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.|1 week||||Participants|||Count of Participants
1364522|NCT01632683|Secondary|Number of Particpants Requiring Adjuncts to Assist Intubation|The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.|1 week||||Participants|||Count of Participants
1364523|NCT01632683|Secondary|Graded Score of Laryngeal View Achieved|Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view.|1 week|Cormack-Lehane grade|||participants|grade||Number
1364524|NCT01632683|Secondary|Intubation Time|Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide|1 week||||seconds||Inter-Quartile Range|Mean
1364525|NCT01632683|Primary|Intubation Success Rate|Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide|1 week||||participants|||Number
1364526|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)|Urinary excretion of TXAM, after correcting for urinary creatinine. TXAM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of TXAM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.|Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable TXAM data at specific time points.|||percent change in TXAM||Inter-Quartile Range|Median
1364527|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)|Urinary excretion of PGIM, after correcting for urinary creatinine. PGIM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGIM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.|Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable PGIM data at specific time points.|||percent change in PGIM||Inter-Quartile Range|Median
1364528|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)|Urinary excretion of PGEM, after correcting for urinary creatinine. PGEM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGEM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.|Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, 6 to 12 h, and 12 to 24 hours post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable PGEM data at specific time points.|||percent change in PGEM||Inter-Quartile Range|Median
1364529|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation|Percent change from baseline of PGE synthesis=(postdose PGE synthesis–baseline PGE synthesis)/baseline PGE synthesis*100, where the unit of measure for PGE synthesis is nanograms per milliliter (ng/ml).|Baseline, 0.5 hours (h), 1 h, 2 h, 8 h, 24 h, and 144 h post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable PGE data at the specific time points.|||percent change in PGE||Inter-Quartile Range|Median
1364530|NCT01632579|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023703|Area under the concentration time curve from the time of dosing to the time of the last observation.|Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose|Pharmacokinetic (PK) population: All participants who received at least 1 dose of study drug and had evaluable AUC data.|||hour*nanograms per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1364531|NCT01632579|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703||Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose|Pharmacokinetic (PK) population: participants who received at least 1 dose of study drug and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1364532|NCT01632579|Primary|Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE|AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible study drug relatedness, is located in the Reported Adverse Events module.|Baseline up to Day 7 post-dose|Safety population: participants who received at least 1 dose of study drug or placebo, whether or not he/she completed all the protocol requirements.|||Participants|||Count of Participants
1364533|NCT01632423|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364534|NCT01632423|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364535|NCT01632423|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364536|NCT01632423|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364537|NCT01632423|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure|||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
1364538|NCT01632345|Secondary|Percentage of Participants With At Least 1 AE in Weeks 0-96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 96 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-96.|Up to Week 96|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
1364539|NCT01632345|Secondary|Percentage of Participants With At Least 1 AE in Weeks 0-48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 48 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-48.|Up to Week 48|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
1364585|NCT01631825|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score.~A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1376635|NCT01490931|Primary|Comparison of Pain Intensity Scores at 2 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||2 Hours||||millimeters||Standard Error|Mean
1364540|NCT01632345|Secondary|Change From Baseline in CD4 Cell Count at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|A secondary endpoint in Part I/II combined was the change from baseline in the CD4 count at Week 96 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 96|The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 96 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
1364541|NCT01632345|Secondary|Change From Baseline in CD4 Cell Count at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the change from baseline in the CD4 count at Week 48 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 48|The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 48 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
1364542|NCT01632345|Secondary|Change From Baseline in CD4 Cell Count at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
1364543|NCT01632345|Secondary|Change From Baseline in CD4 T Lymphocyte Cell Count at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)|Evaluation of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, and 200 mg), compared with participants receiving efavirenz 600 mg. The Observed Failure (OF) approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
1364544|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-96. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined.|Week 96|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 96 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364545|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Evaluation of the antiretroviral activity of doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA for 24 weeks, as measured by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. This primary outcome was analyzed for RNA <200 copies/mL in Part I & Part II combined.|Week 48|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV RNA (<200 copies/mL) at 48 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364546|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This secondary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364547|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay.The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364548|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.|Week 96|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 96 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364549|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.|Week 48|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 48 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364550|NCT01632345|Primary|Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364551|NCT01632345|Primary|Percentage of Participants With Virologic Response (HIV-1 RNA) < 40 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy.This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1364552|NCT01632345|Primary|Percentage of Participants With CNS Events by Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 24 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
1364553|NCT01632345|Primary|Percentage of Participants With CNS Events by Week 8: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 8 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-8.|Up to Week 8|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
1364583|NCT01631825|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness. The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.~The data at week 52 is shown."|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of participants|||Number
1364554|NCT01632345|Primary|Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was assessed for Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
1364555|NCT01632345|Primary|Percentage of Participants Who Discontinued Study Therapy Due to AEs in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who discontinued therapy due to an AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product.The percentage of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.|||Percentage of participants||95% Confidence Interval|Number
1364556|NCT01632345|Primary|Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.|||Percentage of participants||95% Confidence Interval|Number
1364557|NCT01632280|Secondary|Change From Baseline in Inhibitory Control Over Food as Measured by the Stop Signal Reaction Task|"Inhibitory control over food was measured with a Stop Signal Task that was modified with the presence of distractors of two types: images of food and neutral images (control). The Stop Signal Task is a computerized task that evaluates an individual’s ability to interrupt a motor response after its initiation (Logan 1994). Subjects were asked to press a response key matching the direction of an arrow, but refrain from pressing when an auditory cue (stop signal) appeared (25% trials). The main outcome of the task is the Stop-Signal-Reaction-Time (SSRT), in milliseconds, which reflects how long it takes to inhibit a response when a stop signal appears. The SSRT is considered a laboratory measure of inhibitory control capacity. Shorter SSRT reflects more efficient inhibitory control. Here a reduction of SSRT from baseline to 12 months indicates improvement in inhibitory capacity. We provide SSRT changes for food and neutral images, reflecting specific and general effects, respectively."|12 month follow-up vs. Baseline|1 participant withdrew prior to the 12 month follow-up and 2 participants were lost to follow-up prior to the 12 month follow-up.|||milliseconds (ms)||Standard Deviation|Mean
1364558|NCT01632280|Secondary|Eating Disinhibition as Measured by the Three Factor Eating Questionnaire (TFEQ)|Eating Disinhibition is an eating behavior trait that reflects a tendency towards overeating and eating opportunistically in an obesogenic environment. Examples include eating in response to negative affect, overeating when others are eating, not being able to resist temptations to eat, and overeating in response to the palatability of food (Bryant, King and Blundell. Obes Rev. 2008;9:409-19). Eating disinhibition was measured using the Three Factor Eating Questionnaire (TFEQ), which contains 16 questions for this factor. Responses are scored 0 or 1 and summed, thus eating disinhibition score ranges from 0 to 16. Higher scores denote higher levels of eating disinhibition.|Baseline and 12 months follow up|1 participant withdrew prior to the 12 month follow-up and 2 participants were lost to follow-up prior to the 12 month follow-up.|||units on a scale||Standard Deviation|Mean
1364559|NCT01632280|Primary|Weight Change|Participants will be weighed at the indicated time points. Weight loss at 12 months will be the primary outcome of the study.|Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up|1 Participant withdrew prior to obtaining outcome data at the 10th day of tDCS, 1 participant was lost to follow-up prior to the 3-month follow-up visit, and 1 participants were lost to follow-up prior to obtaining outcome data at the 6-month follow-up visit.|||pounds (lbs)||Standard Deviation|Mean
1364560|NCT01632267|Secondary|Number of Disability Claims|Number of disabiity claims during study window|During the one year study window (April 1, 2010 to April 1, 2011)|||||||
1364561|NCT01632267|Secondary|Number of Medical Absence Days|Number of medical absence days during study window|During the one year study window (April 1, 2010 to April 1, 2011)|||||||
1364562|NCT01632267|Primary|Number of Outpatient Visits|Number of outpatient healthcare visits during study window|During the one year study window (April 1, 2010 to April 1, 2011)||||units on a scale||Standard Deviation|Mean
1364563|NCT01632215|Secondary|Chronic Pain|Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain|6 months|||||||
1364564|NCT01632215|Primary|Pain Intensity|Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain|6 months||||units on a scale||Standard Deviation|Mean
1364565|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.|From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.|||Percentage of participants||95% Confidence Interval|Number
1364566|NCT01632150|Primary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.|||Percentage of participants||90% Confidence Interval|Number
1364567|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.|From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment|All participants who received thalidomide, elotuzumab, and dexamethasone (40), including those who had cyclophosphamide added to the regimen (11).|||Percentage of participants||95% Confidence Interval|Number
1364568|NCT01632150|Primary|Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment|All participants who received thalidomide, elotuzumab, and dexamethasone (40) including those who had cyclophosphamide added to the regimen (11).|||Percentage of participants||90% Confidence Interval|Number
1364569|NCT01632020|Primary|Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.||||||
1364570|NCT01632020|Primary|Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.||||||
1364571|NCT01631929|Primary|Time to Achieve Patient Stabilization|"Time needed to achieve patient stabilization defined by:~Plasmatic glucose < 250 mg/dl~Blood pH > 7.3~Plasmatic bicarbonate > 15 mmol/L"|Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)||||Hours||95% Confidence Interval|Mean
1364572|NCT01631864|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set (SAS): The SAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
1364573|NCT01631864|Secondary|Oxidative Metabolism|Oxidative metabolism was assessed by indirect calorimetry.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.|||carbon dioxide to oxygen ratio||95% Confidence Interval|Least Squares Mean
1364574|NCT01631864|Secondary|Local Adipose Tissue Lipolysis, Glycerol Concentrations|Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.|||micro mol/L||95% Confidence Interval|Geometric Mean
1364575|NCT01631864|Primary|Change From Baseline in Insulin Sensitivity Index|The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.|baseline, 8 weeks|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.|||ug/kg*min/(mmol/L*pmol/L)||95% Confidence Interval|Mean
1364576|NCT01631825|Secondary|Each Item of UPDRS Part 4|The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
1364577|NCT01631825|Secondary|Each Item of UPDRS Part 3 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
1364578|NCT01631825|Secondary|Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state).~A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364579|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Average of on State and Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
1364580|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
1364588|NCT01631825|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364589|NCT01631825|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Baseline, up to 54 weeks after dosing|FAS subjects with measurable off time at baseline, LOCF|||Hours||Standard Deviation|Mean
1364590|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Average of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state).~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364591|NCT01631825|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state).~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1364592|NCT01631825|Primary|Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters.~AEs of special interest (1-3) are defined as below:~sudden onset of sleep~obsessive-compulsive disorder or impulse-control disorder~hallucination, delusion~Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed."|Up to 55 weeks after dosing|Safety set (SS)|||participants|||Number
1364593|NCT01631812|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.~-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS|||participants|||Number
1364594|NCT01631812|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Up to 54 weeks after dosing|FAS subjects with “off state” at baseline|||Hours||Standard Deviation|Mean
1364595|NCT01631812|Secondary|UPDRS Part 2 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 weeks after dosing UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing||||Scores on a scale||Standard Deviation|Mean
1364596|NCT01631812|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) up to 54 weeks after dosing UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1364597|NCT01631812|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.|"Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.~*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)|||participants|||Number
1364598|NCT01631682|Primary|Change From Baseline Skin Conductance Response|Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens.|48hrs||||microSiemens||Standard Deviation|Mean
1364599|NCT01631656|Primary|IGA of Improvement|Investigator’s Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or “No inflammatory signs of rosacea” to 6 = “Severe inflammatory signs of rosacea.”|6 weeks||||units on a scale||Standard Deviation|Mean
1364600|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364601|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364602|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364603|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364604|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364605|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364606|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364607|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364608|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364609|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364610|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364611|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364630|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364612|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364613|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364614|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364615|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364616|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364617|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364618|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364619|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364620|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364882|NCT01628107|Secondary|Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48||Week 1 up to Week 48|"Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
1364621|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364622|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364623|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364624|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364625|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364626|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364627|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364628|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364629|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1364899|NCT01627860|Primary|Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).||Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1364631|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364632|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364633|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364634|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364635|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364636|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364637|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364638|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|6 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
1364639|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
1364640|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|4 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
1364641|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|3 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
1365992|NCT01611662|Primary|Pathological Complete Response Rate Following Chemotherapy Before Surgery|Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1364642|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|2 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
1364643|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|1 hour after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
1364644|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the subject receiving an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
1364645|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364646|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364647|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364648|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364649|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364650|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364651|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1364652|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1365025|NCT01625845|Secondary|Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment|An anti-inflammatory cytokine measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One participant, with extreme outlier values at pre- and post-treatment, was excluded from analyses.|||pg/mL||Standard Error|Mean
1364653|NCT01631435|Primary|Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon|"the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy.~The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy.~Each patient was classified as follows:~Active Crohn's disease is likely~Active Crohn's disease is NOT likely~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"|All the end points and outcomes measures will be evaluated within 4 months from end of enrollment|subjects with symptoms associated with Crohn's disease|||number of subjects|||Number
1364654|NCT01631331|Secondary|Tumor Size Measurements Before and After Short Term Vismodegib Treatment|We measured the length and width of all tumors (target and non-target) before and after vismodegib treatment.|4 months (average)|6 of the 11 patients who completed the study had multiple BCCs. We followed 13 target BCCs and 30 non-target BCCs for potential tumor size change from these patients.|||percentage change in tumor size|basal cell carcinomas|95% Confidence Interval|Mean
1364655|NCT01631331|Secondary|Tumor Recurrence Rate of Treated BCCs|Recurrence rate of BCCs during a 22 month average (range 12 to 28 months) follow up period.|average of 22 months|11 patients completed the trial and 13 target BCCs were excised.|||BCCs|BCCs||Count of Units
1364656|NCT01631331|Secondary|Number of Tumors Demonstrating Histologic Cure|Determination of histologic cure (no residual BCC on the ﬁrst piece of excised tissue) post serial sectioning of parafﬁn embedded Mohs specimens|Average of 4 months|Patients each had 1 to 2 target BCCs identified at baseline for surgical excision and were treated with vismodegib for an average of 4 months. Only target lesions are included in this analysis.|||BCCs|BCCs||Count of Units
1364657|NCT01631331|Primary|Percent Change in Surgical Defect Area After the Treatment Period Using Calipers and Photographs Was Calculated|At baseline, we selected 1 to 2 tumors per patient for surgery (13 target tumors selected). At baseline,1 Mohs surgeon measured the estimated surgical defect area around the target tumor. For tumors to be excised by Mohs we defined estimated surgical defect as the tumor size plus a 2-mm circumferential margin, presuming tumor clearance after a Mohs stage-1 excision. For the tumor undergoing standard (non-Mohs) excision, we used tumor size plus a standard 4-mm margin11 for the estimated surgical defect. On the day of the surgery, we measured the surgical defect area as the final tumor-free defect after the Mohs procedure or non-Mohs excision immediately before closure. We used the Image J software program (National Institutes of Health, Bethesda, MD) to calculate tumor area (cm2). Only target tumors are included in this analysis.|average of 4 months|Only patients who were treated with vismodegib for an average of 4 months were included in our analysis. Only target tumors are included in this analysis.|||percentage size change from baseline|BCCs|95% Confidence Interval|Mean
1364658|NCT01631227|Primary|Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline|Change from baseline of diastolic blood pressure (DBP), sitting|8 weeks|Full analysis subject sample|||mmHg||Standard Deviation|Least Squares Mean
1364659|NCT01631149|Secondary|Nausea and Vomiting|"Using a yes - no questionnaire, the patients will be asked whether they are nauseated or not or whether they vomited. In fact yes indicates the nr of participants.~No statistical analysis was performed."|Measurements will be made during the stay in the operating room for an average period of 3 hours||||participants|||Number
1364660|NCT01631149|Secondary|Postoperative Sedation Score|"Using a 5-point sedation scale, sedation levels will be obtained throughout the postoperative period.~0 = wide awake 5= severely sedated, The sedation data were averaged over time."|Measurements will be made during the stay in the operating room for an average period of 3 hours||||units on a scale (0-5)||Standard Error|Mean
1364661|NCT01631149|Secondary|Post-operative Pain|"Using a 10 cm visual analogue score pain relief score will be measured. 0 = no pain 10 = most severe pain~No statistical analysis was performed!"|measurements are made in the recovery room following surgery for an average prior of 1 hour|The pain data were averaged over time and compared by t-test between groups|||units on a scale (0-10 cm)||Standard Deviation|Mean
1364662|NCT01631149|Secondary|Breathing|"In the recovery room the respiratory rate will be measured continuously using the Respir8 respiratory rate monitor. The data will be recorded on the CRF at 15 min intervals.~Breathing rate units are number of breaths as measured in 1 min.~Comparison by t-test: NS between treatments"|Measurements will be made during the stay in the recovery room for an average period of 3 hours|In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test|||breaths per min||Standard Deviation|Mean
1364663|NCT01631149|Primary|Surgical Rating Scale|"During the procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale. In order to reduce variability in the surgical rating all surgeries will be performed by one single surgeon. The rating scale will be a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals. In case of a sudden change in surgical conditions additional scores will be added to the case record form. If conditions are poor (score 1 or 2), muscle relaxation will be increased, a score of 1 will be used.~In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test"|Measurements will be made during the stay in the operating room for an average period of 3 hours|Each participant that was dosed was analyzed|||units on a scale (1-5)||Standard Deviation|Mean
1364664|NCT01631110|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase from baseline||95% Confidence Interval|Number
1364921|NCT01627561|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)||||Subjects|||Number
1364665|NCT01631110|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
1364666|NCT01631110|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects|||Participants|||Number
1364667|NCT01631110|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
1364668|NCT01631071|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase from baseline||95% Confidence Interval|Number
1364669|NCT01631071|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
1364670|NCT01631071|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)||||participants|||Number
1364671|NCT01631071|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
1364672|NCT01630811|Secondary|Change in Aggressive Behavior|Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS). It consists of a scale from 0 - 40, and a lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. Reported is the mean difference in scores from baseline to 8 weeks. A positive score indicates more aggressive behavior and a negative score indicates less aggressive behavior.|Baseline and 8 weeks|One subject withdrew at the time of crossover.|||units on a scale||Standard Deviation|Mean
1364673|NCT01630811|Primary|Primary Safety Endpoints|Number of serious adverse events|Week 0 through week 25||||Participants|||Count of Participants
1364674|NCT01630811|Primary|Change in Maladaptive Behaviors|Demonstrate a change in frequency and intensity of maladaptive behaviors as measured by the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8 weeks over subjects given placebo. This checklist consists of 20 questions relating to behavior and the reported total score is on a scale from 0 to 60. A lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. The below values are the difference in ABC scores from baseline to 8 weeks. A negative difference indicates improved behavior.|Baseline and 8 weeks|One subject withdrew at the time of crossover.|||units on a scale||Standard Deviation|Mean
1364675|NCT01630694|Secondary|Mean Tongue Volume|The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart|||cubic centimeters||Standard Deviation|Mean
1364676|NCT01630694|Primary|Mean Hyomental Distance Ratio|A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart|||ratio||Standard Deviation|Mean
1364716|NCT01629784|Primary|Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture|In order to evaluate the immediate effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a written questionnaire to assess knowledge about CLE and sun protection immediately before and after the educational lecture. The percentage of subjects who correctly answered a knowledge assessment item were calculated pre- and post-educational lecture.|immediately before and after an educational lecture||||percentage of participants|||Number
1365993|NCT01611571|Secondary|Change in FN BMD at 18 Months|Change in the Femoral Neck BMD at 18 month|18 months||||% change in TH BMD||Standard Deviation|Mean
1364677|NCT01630616|Primary|Apparent Terminal t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Apparent terminal t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. The apparent terminal t1/2 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg apparent terminal t1/2 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available t1/2 data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1364678|NCT01630616|Primary|Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Tmax is the time required to reach Cmax. The Tmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Tmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available Tmax data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||Hours||Full Range|Median
1364679|NCT01630616|Primary|Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. The Cmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Cmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available Cmax data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||nM||95% Confidence Interval|Geometric Mean
1364680|NCT01630616|Primary|AUC0-168 for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Area Under the Plasma Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The AUC0-168 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-168 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available AUC0-168 data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||μM·hr||95% Confidence Interval|Geometric Mean
1364681|NCT01630616|Primary|AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Area Under the Plasma Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The AUC0-inf data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-inf data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available AUC0-inf data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||μM·hr||95% Confidence Interval|Geometric Mean
1364682|NCT01630616|Secondary|Change From Baseline in Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) at 168 Hours Postdose|Urinary aminoterminal crosslinked telopeptide of Type I collagen (uNTx/Cr) is a biochemical marker of bone resorption. Odanacatib selectively and potently inhibits cathepsin K (CatK), the primary catalyst of bone resorption. Since CatK is the enzyme responsible for bone matrix degradation it is possible to use bone resorption biomarkers to quantify pharmacodynamic effects in short term clinical studies. CatK cleaves the N-telopeptide of collagen type I to form NTx and also cleaves the serum C-terminal telopeptide of collagen type I (1-CTP – itself generated by the action of matrix metalloproteases) to generate CTx. Urine NTx measurements (in bone collagen equivalents [BCE]) have been normalized to creatinine clearance.|Baseline (predose Day 1) and 168 hours postdose|The population analyzed included all randomized, treated participants who had available uNTx/Cr data for Baseline and 168 hours.|||nmol[BCE]/mmol[creatinine])||Geometric Coefficient of Variation|Geometric Mean
1364683|NCT01630616|Primary|Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available t1/2 data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1364684|NCT01630616|Primary|Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|Tmax is the time required to reach Cmax. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available Tmax data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||Hours||Full Range|Median
1364782|NCT01628926|Secondary|Effective Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
1364685|NCT01630616|Primary|Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|"Cmax is a measure of the maximum amount of drug in the plasma after the drug dose is given. The Method of Dispersion is more accurately described as Percent Geometric Coefficient of Variation. PK analysis was not performed on participants receiving placebo."|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available Cmax data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||nM||Geometric Coefficient of Variation|Geometric Mean
1364686|NCT01630616|Primary|Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|"Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The Method of Dispersion is more accurately described as Percent Geometric Coefficient of Variation. PK analysis was not performed on participants receiving placebo."|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available AUC0-168 data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
1364687|NCT01630616|Primary|Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|"Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The Method of Dispersion is more accurately described as Percent Geometric Coefficient of Variation. Pharmacokinetic (PK) analysis was not performed on participants receiving placebo."|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available AUC0-inf data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
1364688|NCT01630616|Primary|Number of Participants Who Report an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Day 14|The population analyzed consisted of all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1364689|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant’s Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS|||participants|||Number
1364690|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS|||participants|||Number
1364691|NCT01630135|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 1, and Week 2/Early Withdrawal (EW)|FAS. Participants who were withdrawn before Visit 3 (Week 1) were not included in the analysis for Week 1.|||participants|||Number
1364692|NCT01630135|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1364783|NCT01628926|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
1365026|NCT01625845|Secondary|Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||pg/mL||Standard Error|Mean
1364693|NCT01630135|Secondary|Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1364694|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
1364695|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
1364696|NCT01630135|Secondary|Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1364697|NCT01630135|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1376636|NCT01490931|Primary|Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||90 minutes post-dose||||millimeters||Standard Error|Mean
1364698|NCT01630135|Secondary|Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1364699|NCT01630135|Secondary|Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
1364700|NCT01630135|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1364701|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at the Indicated Days|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.|Baseline; Days 1 through 14|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1364702|NCT01630135|Secondary|Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
1364784|NCT01628926|Secondary|On Time With Dyskinesia Disturbing Daily Activities|Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period.|||Hours||Standard Deviation|Mean
1364703|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at Week 1 and Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.|Baseline; Week 1 and Week 2|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
1364704|NCT01630135|Primary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (2 weeks)|Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication|||Scores on a scale||Standard Error|Least Squares Mean
1364705|NCT01630109|Secondary|Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics|This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic.|12 hours||||Percentage of complete studies|||Number
1364706|NCT01630109|Secondary|Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo.|12 hours||||minutes||Standard Deviation|Mean
1364707|NCT01630109|Secondary|Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.|12 hours||||minutes||Standard Deviation|Mean
1364708|NCT01630109|Primary|Difference in Treatment vs. Placebo in Pill Capsule Completion Rates|This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).|12 hours||||percentage of complete capsule studies|||Number
1364709|NCT01629953|Primary|Total Employment|Total amount employed over 1 year follow-up period|1 years||||Participants|||Count of Participants
1364710|NCT01629953|Primary|Employment|Number of veterans finding work within 6 months|within 6 months||||Participants|||Count of Participants
1364711|NCT01629862|Primary|Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).|Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline.|3 months (compared to baseline)||||percentage of brachial artery diameter||Standard Deviation|Mean
1364712|NCT01629823|Primary|Methacholine Reactivity|The primary outcome measure was the change in provocative concentration of methacholine causing a 20% fall in forced expiratory volume in 1 second (FEV₁) (PC20) from baseline to 12 weeks. Modified American Thoracic Society guidelines were followed for pre-bronchodilator spirometry and methacholine challenge testing using the 5 breath dosimeter technique. Up to eleven doses, each a doubling concentration of methacholine (Provocholine™), were inhaled starting at 0.03 mg/mL until a 20% or greater fall in FEV₁ occurred; the maximum dose was 32 mg/mL. Breaths each of doubling concentrations of methacholine were inhaled from a calibrated DeVilbiss™ 646 nebulizer.|12 weeks after randomization||||mg/mL||95% Confidence Interval|Geometric Mean
1364713|NCT01629797|Secondary|Number of Correct Responses to Questionnaire Items Before and 2 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and two months after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and two months post-educational lecture.|before and 2 months after an educational lecture||||participants|||Number
1364714|NCT01629797|Primary|Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture|In order to evaluate the immediate effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and post-educational lecture.|immediately before and after an educational lecture||||participants|||Number
1364715|NCT01629784|Secondary|Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a questionnaire to assess knowledge about CLE and sun protection behaviors immediately before and three months after an educational lecture. The percentage of subjects who correctly answered a knowledge or behavioral assessment item were calculated pre- and three months post-educational lecture.|before and 3 months after an educational lecture||||percentage of participants|||Number
1364717|NCT01629771|Primary|World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores|The WHODAS 2.0 is a generic health and disability assessment tool that describes effects of disease on six domains: Cognition, Mobility, Self-Care, Getting Along, Life Activities, and Participation in Society. Responses are measured on a 5-point scale from 1 (no difficulty) to 5 (extreme difficulty or cannot do). Scores are calculated using a WHO SPSS 36 version syntax for employed subjects and a WHO SPSS 32 version syntax for unemployed subjects. Scores for each domain range from 0 to 100, where 0 is associated with no impairment of health status, and 100 is associated with a greater impairment of health status.|Assessed after enrollment||||units on a scale||Inter-Quartile Range|Median
1364718|NCT01629771|Primary|Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores|The LFSQQ was developed to assess quality of life in subjects with lymphatic filariasis through seven domains: Mobility, Self-Care, Usual Activities, Disease Burden, Pain/Discomfort, Psychological Health, and Social Participation. Items are scored on a 5-point scale (no problem, mild, moderate, severe, most severe), and scores for each domain are calculated based on the number of questions answered and the raw scores. Scores for each domain range from 0 to 100, where 0 is associated with a worse quality of life and 100 is associated with a better quality of life.|Assessed after enrollment||||units on a scale||Inter-Quartile Range|Median
1364719|NCT01629771|Primary|Dermatology Life Quality Index (DLQI) Domain Scores|The DLQI is a 10-item questionnaire measuring skin-specific quality of life through six domains: Symptoms & Feelings, Daily Activities, Leisure, Work & School, Personal Relationships, and Treatment. Symptoms & Feelings, Daily Activities, Leisure, and Personal Relationships are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 3 is associated with a large effect on a patient's life. Work & School and Treatment are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 6 is associated with a large effect on a patient's life.|Assessed after enrollment||||units on a scale||Inter-Quartile Range|Median
1364720|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated. A higher number indicates a higher percentage of non-viable cells relative to the total cell count.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
1364721|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
1364722|NCT01629706|Primary|Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of cells (viable and non-viable) was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
1364723|NCT01629706|Primary|Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and transferred into well plates, each containing a soaking solution. Following a soaking duration of approximately 30 minutes, lenses were rinsed and transferred in individual glass vials. The cell content from the lens wash was taken to a laboratory and incubated with live/dead stains. The total number of cells (viable and non-viable) were counted using a microscope. Cells collected from right and left lens were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
1364724|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable cells was counted using a microscope. Cells collected from right and left eyes were pooled.Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
1364725|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of viable cells was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
1365994|NCT01611571|Secondary|New Morphometric Vertebral Fractures|counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study|baseline through 18 months||||vertebral fracture|||Number
1364726|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1|"The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from each lens and each eye were counted separately using a microscope. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated.~A higher number indicates a higher percentage of non-viable cells relative to the total cell count."|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
1364727|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from each lens and each eye were counted separately using a microscope. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
1364728|NCT01629706|Primary|Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory. The total number of fluorescein-stained cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in fluorescein-stained cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
1364729|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable (dead) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in non-viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
1364730|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial (corneal) cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/ dead stains. The number of viable (alive) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
1364731|NCT01629693|Primary|"Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30"|Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.|Baseline, Day 30|This analysis population includes all participants who completed the protocol and had no major protocol violations.|||units on a scale||Standard Deviation|Mean
1364732|NCT01629667|Secondary|Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|From the start of study treatment through Week 88|"The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received. Here, n is number of participants analysed at given time point."|||Percentage of participant|||Number
1364733|NCT01629667|Secondary|Mean Serum Concentration of Tralokinumab|The mean serum concentration of Tralokinumab were observed.|Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88|"The Pharmacokinetic population included all participants who received at least one dose of tralokinumab and had at least one detectable trough (Weeks 4, 48 or 72 only) serum concentration measurement. Here, n is number of participants analysed at given time point."|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
1364734|NCT01629667|Secondary|Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)|The PGI-C is a single-item, global assessment designed to capture participant-perceived change in their IPF health condition using a 7-point scale (-3 = very much improved, 0 = no change, about the same, 3 = very much worse).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
1364735|NCT01629667|Secondary|Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)|The PGI-S is a single-item, global assessment of participant-perceived IPF severity. The assessment was designed to capture participant perceived IPF-related health status. Participants rate their IPF severity using a 5-point scale (1 = very mild, 5 = very severe).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
1365995|NCT01611571|Secondary|Change in Forearm Bone Density|change in 1/3 radius of forearm bone density as measured by DXA|baseline and 18 months||||% change in 1/3 Radius BMD||Standard Deviation|Mean
1364736|NCT01629667|Secondary|Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72|The EQ-5D-3L is a standardized PRO used to capture respondent’s general health status. The questionnaire assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 response options (no problem, some or moderate problems, and unable or extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analog scale, where the participants were asked to rate their current health on a scale of 0-100, with 0 being the worst imaginable health state.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
1364737|NCT01629667|Secondary|Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72|The EXACT-IPF is a 14-item daily dairy used to capture the IPF related symptoms completed by the participants using an eDiary. The EXACT-IPF total score is the sum of all items ranged from 1 to 14. EXACT-IPF is an interval-level scale ranging from 0 to 100, where the higher scores indicate more severe condition. The EXACT-IPF used Likert scales (with 3 to 6 response options each) to capture participant reported IPF-related symptoms. The scores are the simple sum of item responses for each domain or single item.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
1364738|NCT01629667|Secondary|Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 72|The SGRQ is a 50-item Patient-reported outcome (PRO) instrument developed to measure respiratory-related health status via 76 weighted responses. The SGRQ is divided into two parts. Part 1 asks respondents to consider the last 3 months and report on their respiratory symptoms using 5-point Likert scales. Part 2 asks respondents to consider their current state and respond to a series of dichotomous yes/no items related to their activities (activities that cause or were limited by breathlessness) and impacts (social functioning, psychological disturbances resulting from airways disease). Total scores and domain scores (symptoms, activities, and impact on daily life) were scored from 0-100, where lower scores indicate better health status.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
1364739|NCT01629667|Secondary|Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72|The UCSD SOBQ is a 24-item questionnaire designed to capture patient-reported shortness of breath. Respondents were asked to rate their breathlessness during 21 activities of daily living using a 6-point scale (0 = not at all breathless, 5 = maximally breathless or too breathless to do this activity). In addition to the 21 activity items, the UCSD SOBQ includes 3 additional questions about limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. The UCSD SOBQ was scored by summing responses across all 24 items to form a total score. Scores range from 0-120 with higher scores indicative of greater shortness of breath.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
1364740|NCT01629667|Secondary|Number of Participants With Clinical Global Impression of Change Scores|The CGI-C is a single, clinician completed, item designed to capture the clinicians overall impression of change in IPF severity from the baseline state at Screening. Clinicians were asked to rate the participants IPF severity relative to their state at baseline using a 7-point scale (-3 = very much worse, 0 = no change, about the same, 3 = very much improved).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
1364741|NCT01629667|Secondary|Number of Participants With Clinical Global Impression of Severity Scores|The CGI-S is a single, clinician completed, item designed to capture the clinician’s impression of the participants IPF severity. Clinicians were asked to consider their experience in this participant population and rate the overall IPF severity of the participant using a 5-point scale (1 = very mild, 5 = very severe).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
1364742|NCT01629667|Secondary|Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72|Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Liter||Standard Deviation|Mean
1364743|NCT01629667|Secondary|Change From Baseline in Percent-predicted FEV1 Through Week 72|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1 = (observed value)/(predicted value) * 100%.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percent of predicted FEV1||Standard Deviation|Mean
1364744|NCT01629667|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Liter||Standard Deviation|Mean
1364745|NCT01629667|Secondary|Percentage of Participants With Adjudicated Hospitalization|Participants who were hospitalized due to IPF exacerbation were observed. All events that resulted in the hospitalization of participants were adjudicated by an independent committee to determine if the event was due to an IPF exacerbation as follows: 1. Exacerbation or progression of IPF, 2. Result of a complication of IPF, 3. Not related to IPF (alternative diagnosis provided), and 4. Undetermined due to insufficient information.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of participant|||Number
1364746|NCT01629667|Secondary|Percentage of Participants With Adjudicated Mortality|Participants all cause mortality were observed. Events that resulted in participant death were adjudicated into respiratory-related mortality or all other cause mortality by an independent committee.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of participant|||Number
1364747|NCT01629667|Secondary|Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations|"The IPF exacerbations is defined as an acute, clinically significant, deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated according to the protocol definition by an independent committee as follows:~1. Confirmed acute IPF exacerbation, 2. Suspected acute IPF exacerbation, 3. Not an IPF exacerbation with an alternative diagnosis provided if possible, and 4. Undetermined due to insufficient information."|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of participant|||Number
1364748|NCT01629667|Secondary|Change From Baseline in Lung Volumes Through Week 72|Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Liter||Standard Deviation|Mean
1364749|NCT01629667|Secondary|Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68|Participants transcutaneous oxygen saturation were observed by pulse oximetry.|Baseline and Week 68|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percent of oxygen saturation||Standard Deviation|Mean
1364750|NCT01629667|Secondary|Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72|The 6MWT measures the distance that a participant can walk on a measured, flat hard surface in a period of 6 minutes. The 6MWT evaluates the global and integrated responses of all body systems involved during walking.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Meter||Standard Deviation|Mean
1364751|NCT01629667|Secondary|Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72|The single breath technique was used to determine the DLco. The test was performed by qualified pulmonary function technicians with experience performing this study. Acceptable test criteria included:• An inspiratory volume of more than 85% of vital capacity. • A stable breath hold of 10 seconds (+/- 2 seconds) with no leaks, Valsalva or Mueller maneuvers. • Expiration in less than 4 seconds with appropriate clearance of dead space. The average of the two best acceptable maneuvers was used. There must be a minimum of 4 minutes between the performances of each test.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percent predicted DLco||Standard Deviation|Mean
1364752|NCT01629667|Secondary|Percentage of Participants With Disease Progression|Progression-free Survival (PFS) was used to evaluate disease progression and the percentage of participants with disease progression. A participant was classified as having disease progression if at least one of the following criteria were met:• Adjudicated respiratory-related mortality. •Adjudicated hospitalization due to IPF exacerbation. •Confirmed decline in percent-predicted FVC of greater than or equal to (>=) 10%. •Confirmed decline in 6 minute walk test (6MWT) >= 50 meters.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of Participant|||Number
1364753|NCT01629667|Secondary|Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. Tricuspid valve incompetence was the only abnormality reported as TEAE. ECG parameters included heart rate, PR, QRS, QT, and QTc intervals. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
1364754|NCT01629667|Secondary|Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events|Vital signs parameters included heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
1364810|NCT01628692|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR were defined as hepatitis C virus (HCV) RNA levels <lower limit of quantitation, target not detected at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|End of treatment (Week 24)|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
1364755|NCT01629667|Secondary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
1364756|NCT01629667|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pretreatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
1364757|NCT01629667|Primary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52|Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline and Week 52|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percentage of predicted FVC||Standard Deviation|Mean
1364758|NCT01629589|Secondary|Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.|Up to 15 minutes post-vaccination|Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set.|||Participants|||Number
1364759|NCT01629589|Secondary|Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM.~Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer <LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set.|||Participants|||Number
1364760|NCT01629589|Secondary|Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) to Day 28 post-vaccination|Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1364761|NCT01629589|Secondary|Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus.~Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.|||Participants|||Number
1364762|NCT01629589|Secondary|Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test|Day 0 (pre-vaccination) to Day 28 post-vaccination|The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1364763|NCT01629589|Primary|Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.|||Participants|||Number
1365996|NCT01611571|Secondary|Change in Hip Bone Density|change in hip bone density measured by DXA|baseline and 18 months||||% change in TH BMD||Standard Deviation|Mean
1364764|NCT01629290|Primary|Fluoride Concentration and Release|Fluoride release as measured by concentration of fluoride available in the oral cavity at different time periods after the application of 5% NaF varnish and placebo as measured in unstimulated human saliva|Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs|The 15 participants were each involved in each of the successive treatments with Enamel Pro, Duraphat, Vanish, and Placebo, (the order differed for each participant), and to show the differences between baseline and the different treatment levels, the baselines before each of the treatments is listed here along with the relevant treatment.|||ppm||Standard Deviation|Mean
1364765|NCT01629134|Secondary|Rating of Injection Discomfort|The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||scale score||Standard Deviation|Mean
1364766|NCT01629134|Secondary|Comparative Rating With Previous Treatment|Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364767|NCT01629134|Secondary|Return to Social Engagement|Time to return to normal daily activities|4 weeks|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364768|NCT01629134|Secondary|Need for Massage|Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364769|NCT01629134|Secondary|Malleability of Product|Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364770|NCT01629134|Secondary|Ease of Injection|Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364771|NCT01629134|Secondary|Swelling of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects’ lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364772|NCT01629134|Secondary|Bruising of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects’ lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364773|NCT01629134|Primary|Injector Rating of the Natural Look and Feel of the Lips|Percentage of injectors who rated the look and feel of subjects’ lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364774|NCT01629134|Primary|Subject Rating of the Natural Look and Feel of the Lips|Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
1364775|NCT01628965|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.~-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS|||participants|||Number
1364776|NCT01628965|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score|Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1364777|NCT01628965|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|"Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing.~*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)|||participants|||Number
1364778|NCT01628926|Secondary|Dystonia (in the Daytime)|Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).|Baseline, 16 weeks after dosing|Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.|||Percentage of Participants|||Number
1364779|NCT01628926|Secondary|Dystonia (at an Early Hour)|Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.|||Percentage of participants|||Number
1364780|NCT01628926|Secondary|Clinical Global Impression (CGI)|"Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF|||Percentage of Participants|||Number
1364781|NCT01628926|Secondary|Effective Rate in Off Time|"Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing.~On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF|||Percentage of participants||95% Confidence Interval|Number
1364785|NCT01628926|Secondary|On Time Without Dyskinesia Disturbing Daily Activities|"Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing.~On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance.|||Hours/day||Standard Deviation|Mean
1364786|NCT01628926|Secondary|On Time|Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS, LOCF|||Hours/day||Standard Deviation|Mean
1364787|NCT01628926|Secondary|Parkinson's Disease Sleep Scale-2 (PDSS-2)|Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.|Baseline, 16 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364788|NCT01628926|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF|||Hours/day||Standard Deviation|Mean
1364789|NCT01628926|Secondary|UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.~UPDRS 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364790|NCT01628926|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing.~UPDRS Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 8 and 10 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364791|NCT01628926|Primary|Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 16 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1364792|NCT01628913|Secondary|Time to Treatment Failure (TTF)|Time from randomization to the date of the first of the following events:death due to any cause or progressive disease, treatment discontinuation due to toxicity or treatment discontinuation due to patient preference|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.||||||
1364793|NCT01628913|Secondary|Overall Survival (OS)|Time from randomization to the date of death due to any cause|up to approx. 30 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.||||||
1364794|NCT01628913|Secondary|Objective Response Rate|Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for all target and non-target lesions, as well as new lesions as assessed by CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of all target lesions; Overall Response (OR) = CR + PR.|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.||||||
1364795|NCT01628913|Primary|Progression Free Survival (PFS)|PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.|up to approx. 18 months|Full analysis set: The Full analysis set (FAS) comprised all patients who were randomized to study treatment. According to the intent to treat principle, patient was analyzed according to the treatment and strata they had been assigned to during the randomization procedure.|||Months||95% Confidence Interval|Median
1364796|NCT01628848|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Mean change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness at 12 weeks after dosing.~The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided."|Baseline, 12 weeks after dosing|FAS, LOCF|||Percentage of participants|||Number
1364811|NCT01628692|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR were defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at both Week 4 and Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4 and Week 12|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
1364797|NCT01628848|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average score of on state and off state), UPDRS Part 3 sum score, and UPDRS Part 4 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364798|NCT01628848|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average score of on state and off state), and UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364799|NCT01628848|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364800|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364801|NCT01628848|Secondary|UPDRS Part 2 Sum Score (on State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364802|NCT01628848|Secondary|Effective Rate in Off Time|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing.|FAS subjects with measurable off time data at baseline, LOCF|||Percentage of participants||95% Confidence Interval|Number
1364803|NCT01628848|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364804|NCT01628848|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing.|Baseline, 12 weeks after dosing|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
1364805|NCT01628848|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|baseline, 12 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF|||Hours||Standard Deviation|Mean
1364806|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 12 weeks after dosing.~Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1364807|NCT01628848|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1364808|NCT01628692|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)|All treated participants.|||Participants|||Number
1364809|NCT01628692|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories|Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Baseline, post-treatment Week 12 (Follow-up period)|All treated participants. Here ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1365997|NCT01611571|Primary|Change in Spine Bone Density|change in spine bone density at 18 months measured by DXA 18 and 24 months|18 months||||% change in LS BMD||Standard Deviation|Least Squares Mean
1364812|NCT01628692|Primary|Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)|SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Post Treatment Week 12 (Follow-up period)|All participants who were randomized and received at least 1 dose of active study therapy (daclatasvir, simeprevir, ribavirin).|||Percentage of participants||80% Confidence Interval|Number
1364813|NCT01628692|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
1364814|NCT01628692|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
1364815|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥20% From Baseline|Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria|||Percentage of Patients|||Number
1364816|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥10% From Baseline|Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria|||Percentage of Patients|||Number
1364817|NCT01628614|Primary|Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline|Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria|||Millimeters of Mercury (mmHg)|||Number
1364818|NCT01628601|Secondary|Patients Continuing With GANfort® After 18 Weeks|Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364819|NCT01628601|Secondary|Physician Assessment of Adherence to GANfort®|"Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported."|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364820|NCT01628601|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364821|NCT01628601|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364822|NCT01628601|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 18 Weeks|All enrolled patients with complete data for this outcome measure|||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
1364823|NCT01628588|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364824|NCT01628588|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364825|NCT01628588|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364826|NCT01628588|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
1364827|NCT01628588|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure|||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
1364828|NCT01628510|Secondary|The Bayley Scales of Infant Development-3rd Edition (BSID-III)|"The BSID-III is the gold standard for assessing developmental outcome in childhood. Subscale composite scores for language, motor and cognition will be determined.~Language~--Scale Range (higher values represent a better outcome)~Minimum Score: 40~Maximum Score: 160~Motor~--Scale Range (higher values represent a better outcome)~Minimum Score: 40~Maximum Score: 160~Cognition --Scale Range (higher values represent a better outcome)~Minimum Score: 40~Maximum Score: 160"|1 year, 2 years|23 total participants completed Bayley Scales follow-up testing at 1 year; 7 total participants completed Bayley Scales follow-up testing at 2 years.|||units on a scale||Standard Deviation|Mean
1364879|NCT01628107|Secondary|Mean Hemoglobin Levels for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||g/dL||Standard Deviation|Mean
1364829|NCT01628510|Primary|NICU Network Neurobehavioral Scale (NNNS)|The NNNS wasl used to assess neurobehavioral outcome near term equivalent (between 35 weeks and 41 weeks postmenstrual age). This tool consists of eliciting neonatal reflexes and observing behavior. From the assessment, 13 summary scores were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.|35 to 41 weeks (term equivalent); prior to NICU discharge||||Asymmetry Score (units on a scale)||Standard Deviation|Mean
1364830|NCT01628367|Secondary|Pink Esthetic Score|Pink esthetic score per Furhauser et.al. measured at study conclusion where based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture (Fig. 1). Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. Thus a maximum score of 14 is best, and 0 is the worst.|One year||||units on a scale||Standard Deviation|Mean
1364831|NCT01628367|Secondary|Change in Interproximal Bone Levels|Change of interproximal marginal bone loss (mean of mesial and distal sites)|One year||||millimeters||Standard Deviation|Mean
1364832|NCT01628367|Primary|Change in Thickness of Buccal Bone|Change of buccal bone volume over study duration|One year||||millimeters||Standard Deviation|Mean
1364833|NCT01628250|Secondary|Survival Rate|The follow up to the patients after the surgery to evaluate the oncological results of the technique|3 years after the surgery|||||||
1364834|NCT01628250|Primary|Histopathological Outcomes Obtained Through the Surgeries|number of lymph nodes retrieved|14 days after the surgery||||nodes||Standard Deviation|Mean
1364835|NCT01628198|Secondary|Anti-hypertensive Medications|The total number of anti-hypertensive medications at baseline, 6 months, and 12 months|Baseline, 6 months, 12 months|some participants withdrew from the study, some were lost to follow-up|||medications||Standard Deviation|Mean
1364836|NCT01628198|Secondary|Creatinine|Creatinine measures the level of the waste product in the body. The amount of creatinine in the blood depends partly on the amount of muscle tissue you have. Men generally have higher creatinine levels than women.Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL) in adult males and 0.5 to 1.1 milligrams per deciliter in adult females. High levels of creatinine indicates kidney impairment.|baseline, 6 months, 12 months|some participants withdrew from the study, others were lost to followup|||mg/dl||Standard Deviation|Mean
1364837|NCT01628198|Secondary|Blood Urea Nitrogen|A blood urea nitrogen (BUN) test measures the amount of nitrogen in blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out in the urine.|baseline, 6 months, 12 months|some participants withdrew from the study, others were lost to followup|||mg/dL||Standard Deviation|Mean
1364838|NCT01628198|Secondary|Renal Artery Dimensions|Dimensions of renal artery, right and left|baseline and 12 months|some participants withdrew from the study, some were lost to follow up|||mm||Standard Deviation|Mean
1364839|NCT01628198|Secondary|Resistive Index|Renal artery blood flow as measured by Resistive Index. RI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity. the normal value is ~ 0.60, with 0.70 being around the upper limits of normal|Baseline and 12 months|Some participants withdrew from the study, others were lost to follow up|||index||Standard Deviation|Mean
1364840|NCT01628198|Secondary|Renal Aortic Ratio|Renal artery blood flow as measured by Renal Aortic Ratio (RAR) = Peak systolic Velocity renal artery / Peak Systolic Velocity Aorta. A >60% stenosis is reported when there is a >3.5:1 Renal to Aortic Ratio.|Baseline and 12 months|Some participants withdrew from the study, others were lost to follow up|||ratio||Standard Deviation|Mean
1364841|NCT01628198|Secondary|Office Diastolic BP|Different time points office diastolic blood pressure measurements|baseline, 6 month, 12 months|some participants withdrew from the study, and others were lost to follow up.|||mm Hg||Standard Deviation|Mean
1364842|NCT01628198|Secondary|Office Systolic BP|Different time points office systolic blood pressure measurements|baseline, 6 month, 12 months|some participants withdrew from the study, and others were lost to follow up.|||mm Hg||Standard Deviation|Mean
1364843|NCT01628198|Primary|Change in Ambulatory Diastolic Blood Pressure|The change in diastolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.|baseline and 6 months|analysis for participants who returned for follow up|||mmHg mean change||Standard Deviation|Mean
1364844|NCT01628198|Primary|Mean Change in Ambulatory Systolic Blood Pressure|The change in systolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.|baseline and 6 months|analysis for participants who returned for follow up|||mmHg||Standard Deviation|Mean
1364845|NCT01628120|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies|Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.|Baseline, Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, “n” signifies those participants who were evaluable at specified time points.|||Percentage of participants|||Number
1364846|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
1364847|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)|ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator’s discretion.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
1364848|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests|Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator’s discretion.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
1364849|NCT01628120|Other Pre-specified|Number of Participants Who Received Concomitant Medication||Week 1 up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
1364850|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels|Participants with clinically significant change from baseline in hemoglobin levels were upon investigator’s discretion.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
1364851|NCT01628120|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364852|NCT01628120|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364853|NCT01628120|Secondary|Percentage of Participants Who Received Blood Transfusions||Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Percentage of participants|||Number
1364854|NCT01628120|Secondary|Percentage of Participants With Hemoglobin Level Outside Target Range|Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.|Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Percentage of participants|||Number
1364855|NCT01628120|Secondary|Mean Hematocrit Levels for Interval of 12 Weeks|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||Percentage of red blood cells||Standard Deviation|Mean
1364856|NCT01628120|Secondary|Mean Hematocrit Levels: Over Week 1 to 48|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Percentage of red blood cells||Standard Deviation|Mean
1364857|NCT01628120|Secondary|Mean Hemoglobin Levels for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n’ signifies those participants who were evaluable at specified time points.|||g/dL||Standard Deviation|Mean
1364858|NCT01628120|Secondary|Mean Hemoglobin Levels: Over Week 1 to 48||Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||g/dL||Standard Deviation|Mean
1364859|NCT01628120|Secondary|Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||U/kg/week||Standard Deviation|Mean
1364860|NCT01628120|Secondary|Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48||Week 1 up to Week 48|Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
1364861|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Percentage of participants|||Number
1364862|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 37 up to Week 48|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364863|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 25 up to Week 36|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364864|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 13 up to Week 24|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364865|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 12|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Percentage of participants|||Number
1364866|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Up through 7 days after first dose of study drug (Week 1)|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364867|NCT01628107|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies|Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay was used to determine the presence of anti-rhEPO antibodies.|Baseline, Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1364868|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator’s discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
1364869|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)|ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator’s discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
1364870|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests|Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator’s discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
1364871|NCT01628107|Other Pre-specified|Number of Participants Who Received Concomitant Medication||Week 1 up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
1364872|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels|Participants with clinically significant change from baseline in hemoglobin levels were upon investigator’s discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
1364873|NCT01628107|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364874|NCT01628107|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364875|NCT01628107|Secondary|Percentage of Participants Who Received Blood Transfusions||Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||Percentage of participants|||Number
1364876|NCT01628107|Secondary|Percentage of Participants With Hemoglobin Level Outside the Target Range|Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.|Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||Percentage of participants|||Number
1364877|NCT01628107|Secondary|Mean Hematocrit Levels for Interval of 12 Weeks|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||Percentage of red blood cells||Standard Deviation|Mean
1364878|NCT01628107|Secondary|Mean Hematocrit Levels: Over Week 1 to 48|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 48|"FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of red blood cells||Standard Deviation|Mean
1364883|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1364884|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 37 up to Week 48|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364885|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 25 up to Week 36|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364886|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 13 up to Week 24|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, ''number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364887|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 12|Safety analysis set included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1364888|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Up through 7 days after first dose of study drug (Week 1)|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1364889|NCT01628042|Primary|Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||L/hr||95% Confidence Interval|Geometric Mean
1364890|NCT01628042|Primary|Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
1364891|NCT01628042|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM•hr||95% Confidence Interval|Geometric Mean
1364892|NCT01627899|Secondary|Change in 30 Day Mean Glucose Comparing First Month to Last Month After 24 Weeks||24 weeks|Study terminated early by sponsor, no analysis completed.||||||
1364893|NCT01627899|Secondary|Change in Proportion of Subjects With A1C Less Than or Equal to 7.0% at Week 24||24 weeks|Study terminated early by sponsor, no analysis completed.||||||
1364894|NCT01627899|Secondary|Change in FPG From Baseline to 24 Weeks and Over Time|Change in Fasting Plasma Glucose (FPG) from baseline to 24 weeks and over time|24 weeks and over time|Study terminated early by sponsor, no analysis completed.||||||
1364895|NCT01627899|Secondary|Change in A1C From Baseline to Week 12|Change in A1C from baseline to week 12|12 weeks|Study terminated early by sponsor, no analysis completed.||||||
1364896|NCT01627899|Primary|Change in A1C From Baseline to Week 24|Change in A1C from baseline to week 24|24 weeks|Study terminated early by sponsor, no analysis completed.||||||
1364897|NCT01627860|Secondary|Dosage Administration of Topamax During Month 4||Month 4|Participants who have received study medication during month 4.|||mg||Standard Deviation|Mean
1364898|NCT01627860|Secondary|Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4|Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.|Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.|||Percent change||Standard Deviation|Mean
1364900|NCT01627782|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||hour||Standard Deviation|Mean
1364901|NCT01627782|Secondary|Volume of Distribution at Steady-State (Vss) of Ketamine|The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of ketamine at steady state.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||liter||Standard Deviation|Mean
1364902|NCT01627782|Secondary|Total Systemic Clearance (CL) of Ketamine|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||liter per hour||Standard Deviation|Mean
1364903|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||hour*nanogram per milliliter||Standard Deviation|Mean
1364904|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])|The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||hour*nanogram per milliliter||Standard Deviation|Mean
1364905|NCT01627782|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine|The Tmax is defined as actual sampling time to reach maximum observed drug concentration.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Hour||Full Range|Median
1364906|NCT01627782|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ketamine|The Cmax is the maximum observed plasma concentration of drug.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
1364907|NCT01627782|Secondary|Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase|The PGI-C is a 7-point scale that required the subject to assess how much their illness had improved or worsened relative to a baseline state at the beginning of the intervention. The response options were: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse. The scale is rated as, 1=very much improved and 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Full Range|Median
1364908|NCT01627782|Secondary|Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29)|The PGI-S is an 11-point (0 to 10) scale that required the participant to rate the severity of their illness at the time of assessment, relative to the participants past experience. Considering their total experience, the participant was to assess the severity of their depression illness at the time of rating as none, mild, moderate or severe. The scale is rated as, 0=very well and 10=very poor.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Full Range|Median
1366239|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
1364909|NCT01627782|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase|The CGI-I is a 7-point scale that was used to assess how much the participants illness was improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 0= not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Full Range|Median
1364910|NCT01627782|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)|The CGI-S was used to rate the severity of the participants illness at the time of assessment, relative to the clinician’s past experience with participants who had the same diagnosis and improvement with treatment. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to: 0= not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Full Range|Median
1364911|NCT01627782|Secondary|Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Sustained response on Day 15 was defined as achieving an onset of antidepressant response within the first week that is maintained to the end of study Day 15. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Participants|||Number
1364912|NCT01627782|Secondary|Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants who had a MADRS total score of less than or equal to (<=) 10 were considered remitters. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Participants|||Number
1364913|NCT01627782|Secondary|Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants with a reduction in the MADRS total score of greater than or equal to (>=) 50 percent from baseline were defined as responders. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Participants|||Number
1364914|NCT01627782|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Standard Deviation|Mean
1364915|NCT01627782|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Standard Deviation|Mean
1364916|NCT01627561|Secondary|Number of Subjects With of AEs/SAEs Leading to Withdrawal||From Day 0 to Month 12||||Subjects|||Number
1364917|NCT01627561|Secondary|The Number of Subjects Completing the Vaccination Schedule in All Groups.||From first vaccination to the last vaccine dose (from Day 0 up to Month 6)||||Subjects|||Number
1364918|NCT01627561|Secondary|Number of Subjects Reporting the Intake of Concomitant Medication||During the 43-day period (Days 0-42) following vaccination on Day 0 and during the 30-day period (Days 0-29) following vaccination at Month 6||||Subjects|||Number
1364919|NCT01627561|Secondary|Number of Subjects With of AEs/SAEs Leading to Withdrawal||Throughout the study period (From Day 0 to Month 36)||2018-12-31|12/2018||||
1364920|NCT01627561|Secondary|Number of Subjects With Serious Adverse Events (SAEs)||Throughout the study period (From Day 0 to Month 36)||2018-12-31|12/2018||||
1364922|NCT01627561|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)||||Subjects|||Number
1364923|NCT01627561|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)||||Subjects|||Number
1364924|NCT01627561|Secondary|The Number of Subjects With Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism, Including Febrile Convulsion||During the 43-day period (Days 0-42) following vaccination on Day 0||||Subjects|||Number
1364925|NCT01627561|Secondary|Seroprotection Rates to Diphtheria (D) and Tetanus (T) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||At Month 7||2018-12-31|12/2018||||
1364926|NCT01627561|Secondary|Vaccine Response Rates to Filamentous Haemagglutinin (FHA), Pertactin (PRN) and Pertussis Toxoid (PT) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||At Month 7||2018-12-31|12/2018||||
1364927|NCT01627561|Secondary|Anti-measles, Mumps and Rubella Antibody Titres in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||On Days 0 and 42||2018-12-31|12/2018||||
1364928|NCT01627561|Secondary|Anti-measles, Mumps and Rubella Seropositivity Rates in Groups HPV_2D, MMR_DTPa and HPV_2D CO.||On Days 0 and 42||2018-12-31|12/2018||||
1364929|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||2018-12-31|12/2018||||
1364930|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||2018-12-31|12/2018||||
1364931|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Group MMR_DTPa||At Day 0, Month 7 and Month 12||2018-12-31|12/2018||||
1364932|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-Based Neutralization Assay (PBNA) in a Sub-cohort in Group MMR_DTPa||At Day 0, Month 7 and Month 12||2018-12-31|12/2018||||
1364933|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Titres Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||2018-12-31|12/2018||||
1364934|NCT01627561|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.||At Day 0 and Months 7, 12, 18, 24 and 36||2018-12-31|12/2018||||
1364935|NCT01627561|Secondary|Anti-HPV-16/18 Antibody Concentrations|"Antibody concentrations were calculated as geometric mean concentrations (GMCs), assessed by ELISA for the respective groups and expressed as ELISA units per milliliter (EU/mL).~Values for Month 7 were primary outcomes and presented as such. Values past month 7 were not available at the time of posting this record and will be added once validated results become available."|At Day 0, Month 7 and Month 12|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1364936|NCT01627561|Secondary|Number of Subjects Seroconverted for Anti-HPV-16/18 Antibodies|"Seroconversion is defined as the appearance of antibodies (i.e. titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~Values for Month 7 were primary outcomes and presented as such. Values past month 7 were not available at the time of posting this record and will be added once validated results become available."|At Day 0, Month 7 and Month 12|This analysis was based on the ATP cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1364937|NCT01627561|Primary|Anti-HPV-16/18 Antibody Concentrations|Antibody concentrations were assessed by Enzyme-linked-Immunosorbent Assay (ELISA) and expressed as geometric mean titers (GMTs) in ELISA units per milliliter (EU/mL).|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1364938|NCT01627561|Primary|Number of Serconverted Subjects for Anti-HPV-16/18|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.|One month after the last dose of study vaccine (Month 7)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1364939|NCT01627561|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)||||Subjects|||Number
1364940|NCT01627561|Primary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)||||Subjects|||Number
1364941|NCT01627561|Primary|Number of Subjects With AEs and SAEs Leading to Withdrawal||From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)||||Subjects|||Number
1364943|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters|The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin, leukocytes [white blood cells] = WBC, lymphocytes, monocytes, neutrophils and platelets). Results were split into 2 outcomes due to the table size.|42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.|||Subjects|||Number
1364944|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters.|The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin, leukocytes [white blood cells] = WBC, lymphocytes, monocytes, neutrophils and platelets). Results were split into 2 outcomes due to the table size.|42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.|||Subjects|||Number
1364945|NCT01627561|Primary|Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination Dose 2 at Month 6|Note: Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from the TVc.|||Subjects|||Number
1364946|NCT01627561|Primary|Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 43-day period (Days 0-42) post vaccination Dose 1||||Subjects|||Number
1364947|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) following each vaccination||||Subjects|||Number
1364948|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) following each vaccination||||Subjects|||Number
1364949|NCT01627340|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Month 0 - Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.|||Participants|||Count of Participants
1364950|NCT01627340|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.|||Participants|||Count of Participants
1364951|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Any fever = oral temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.|||Participants|||Count of Participants
1364952|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.|||Participants|||Count of Participants
1365027|NCT01625845|Secondary|Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and12 weeks|Participants with missing TNF-a data were excluded from this analysis.|||pg/mL||Standard Error|Mean
1364953|NCT01627340|Secondary|Anti-HBs Antibody Concentration|Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.|||mIU/mL||95% Confidence Interval|Geometric Mean
1364954|NCT01627340|Primary|Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies|A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.|||Participants|||Count of Participants
1364955|NCT01627327|Secondary|Change From Baseline in Trough FEV1 at Treatment Day 84|Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|ITT Population. Only participants with data available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1364956|NCT01627327|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.|Baseline and Day 1|ITT Population. Only participants with data available at the indicated time point were assessed.|||Minutes||Full Range|Median
1364957|NCT01627327|Primary|Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Only participants with data available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1364958|NCT01627249|Secondary|Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser||Baseline to 1-year||||Eyes|||Number
1364959|NCT01627249|Secondary|Total Number of Laser Treatments|Only includes participants that completed the 1 year visit.|between 24 weeks and 1 year||||participants|||Number
1364960|NCT01627249|Secondary|Total Number of Injections Prior to 1 Year|Only includes participants that completed the 1 year visit|Baseline to 1-year|Seven study eyes received 1 injection and 2 eyes received 2 injections of 0.5 mg of ranibizumab prior to the FDA approving a 0.3 mg dosage of ranibizumab for diabetic macular edema treatment.|||Injections||Standard Deviation|Mean
1364961|NCT01627249|Secondary|Overall Change in Retinal Volume|Baseline volume values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 459 scans. One-year volume values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 472 scans. When calculating change in volume, measurements taken on the same machine at both visits were not converted, because the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in volume was calculated after converting either the baseline and/or follow-up value from Spectralis or Cirrus to a Stratus equivalent value in 17 eyes.|Baseline to 1-year|In addition to participants missing the 1-year visit, 46 in the aflibercept group, 53 in the bevacizumab group, and 44 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||mm^3||Standard Deviation|Mean
1364962|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||microns||Standard Deviation|Mean
1364977|NCT01626820|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1364963|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||microns||Standard Deviation|Mean
1364964|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).|||units on a scale||Standard Deviation|Mean
1364965|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).|||units on a scale||Standard Deviation|Mean
1364966|NCT01627249|Secondary|Overall Change in Optical Coherence Tomography Central Subfield Thickness|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||microns||Standard Deviation|Mean
1364967|NCT01627249|Primary|Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).|||units on a scale||Standard Deviation|Mean
1364968|NCT01627002|Secondary|Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose||||percentage of total cells||95% Confidence Interval|Least Squares Mean
1364969|NCT01627002|Primary|Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose||||x10e6 cells/g||95% Confidence Interval|Least Squares Mean
1364970|NCT01627002|Secondary|Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity||Up to 12 time-points up to 48 hours post dose||||ng.h/mL||Standard Deviation|Mean
1364971|NCT01627002|Secondary|Pharmacokinetic Parameters: Terminal Half-life (t1/2)||Up to 12 time-points up to 48 hours post dose||||hours||Standard Deviation|Mean
1364972|NCT01627002|Secondary|Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)||Up to 12 time-points up to 48 hours post dose||||hours||Standard Deviation|Mean
1364973|NCT01627002|Secondary|Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)||Up to 12 time-points up to 48 hours post dose||||ng/mL||Standard Deviation|Mean
1364974|NCT01627002|Primary|Immunogenicity|Anti-drug antibody data|Up to 28 days post dose|Safety analyses were performed on all subjects who received a dose of PA401 or placebo and who had any post-dose assessments|||participants|||Number
1364975|NCT01627002|Primary|Treatment Emergent Adverse Events||up to 14 days post dose|Safety analyses were performed on all subjects who receive a dose of PA401 or placebo and who had any post-dose measurements|||Participants|||Number
1364976|NCT01626820|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1364978|NCT01626820|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever [oral temperature ≥38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination, Any fever = oral temperature ≥38.0 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
1364979|NCT01626820|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling were defined as ecchymosis, induration, redness and swelling above 100 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
1364980|NCT01626820|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Mean
1364981|NCT01626820|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1364982|NCT01626820|Primary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Subjects|||Number
1364983|NCT01626820|Primary|Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Mean
1364984|NCT01626690|Secondary|Temporal Artery Verus SpotOn (3M) Temperature Readings.|Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
1364985|NCT01626690|Secondary|Incidence of Perioperative Cardiac Events.|Incidence of perioperative arrhythmias or myocardial ischemia.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Patients|||Number
1364986|NCT01626690|Secondary|Intraoperative Blood Loss.|Intraoperative blood loss in mL's.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||mL||Standard Deviation|Mean
1364987|NCT01626690|Secondary|Incidence of Postoperative Shivering in Recovery Room.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Number of patients reporting shivering|||Number
1364988|NCT01626690|Secondary|Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
1364989|NCT01626690|Secondary|Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
1364990|NCT01626690|Secondary|Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
1364991|NCT01626690|Primary|Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..|Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
1364992|NCT01626664|Secondary|Change in Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) Total Score|The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.|From date of randomization until the date of first documented progression, up to 36 months|All participants in Intention-to-Treat who had both the values at baseline and last observation|||Units on a scale||Standard Deviation|Mean
1364993|NCT01626664|Secondary|Overall Survival|The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator’s Choice group.|up to 36 months||||percentage of subjects||95% Confidence Interval|Median
1364994|NCT01626664|Secondary|Progression Free Survival|Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared.|From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months||||percentage of subjects||95% Confidence Interval|Median
1364995|NCT01626664|Primary|Overall Response Rate|"Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = > 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment.~Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment."|every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first||||participants|||Number
1364996|NCT01626456|Secondary|Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).|52 weeks|The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
1364997|NCT01626456|Secondary|Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests|Includes incidence >2% but <5%.|52 weeks||||participants|||Number
1364998|NCT01626456|Secondary|Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.|||participants|||Number
1364999|NCT01626456|Secondary|Discontinuation From Study Due to Adverse Events (AEs)|Number of subjects who discontinued the study due to AE.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.|||participants|||Number
1365000|NCT01626456|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data."|52 weeks|The full analysis set consists of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
1365001|NCT01626456|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|This measure includes incidences >5%.|52 weeks|Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.|||participants|||Number
1365002|NCT01626391|Primary|Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine|This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.|8 weeks|Safety Population|||participants|||Number
1365022|NCT01625910|Primary|Body Mass Index Z-score Change|Change in body mass index z-score change over the three month time period|Three months|All enrolled were analyzed with one exception (due to injury and prolonged cast treatment). An intent-to-treat analysis required that, for those who did not have the follow-up measurement, data were filled in using the experience of those in the control group who had follow-up measurements.|||BMI z-score change||Standard Error|Mean
1365003|NCT01626352|Secondary|Progression-free Survival|Defined as the time from first treatment until objective tumor progression, relapse from complete response, or death from any cause. Tumor response is defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment.|After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months|All enrolled patients who have received study treatment.|||months||90% Confidence Interval|Median
1365004|NCT01626352|Secondary|Number of Patients With Treatment-Related Adverse Events (AEs) as a Measure of Safety|A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator’s assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|after cycles 3 and 6 of each 21-day cycle, and up to 30 days after last dose, projected 24 weeks|All enrolled patients who received the study treatment.|||Participants|||Count of Participants
1365005|NCT01626352|Secondary|Overall Response (OR)|Overall response is the number of patients with observed complete or partial response (CR or PR) as assessed using the International Working Group (IMW) revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.|after cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter, projected 18 months|All patients treated with study drugs and having a post baseline response assessment.|||Participants|||Count of Participants
1365006|NCT01626352|Secondary|Overall Survival (OS)|Defined as the time from Day 1 of study drug administration to date of death from any cause.|every 3 cycles during treatment and every 3 months thereafter until progression or death from any cause, projected 18 months|All enrolled patients who have received study treatment.|||months||90% Confidence Interval|Median
1365007|NCT01626352|Secondary|Time to Progression (TTP)|Defined as the time from date of first treatment to the date of first documented disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.|After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months|All enrolled patients who have received study treatment.|||months||95% Confidence Interval|Median
1365008|NCT01626352|Secondary|Duration of Response|Defined as the time from date of first documented confirmed response to date of disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who begin further anticancer therapy prior to disease progression will be censored at the date of last tumor assessment prior to the start date of the anticancer therapy.|After cycles 3 and 6 of each 21-day cycle and every 3 months thereafter until disease progression or relapse from complete response for up to 38 months|All patients treated with study drugs and having a post baseline response assessment of a complete or partial response.|||months||90% Confidence Interval|Median
1365009|NCT01626352|Primary|Number of Patients With a Complete Response|Disease response assessments will be performed using the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires a disappearance of all evidence of disease.|18 months|All patients treated with study drugs and having a post baseline response assessment.|||Participants|||Count of Participants
1365010|NCT01626118|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||units on a scale*hour||Standard Deviation|Mean
1365017|NCT01626118|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
1365011|NCT01626118|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||units on a scale*hour||Standard Deviation|Mean
1365012|NCT01626118|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||units on a scale*hour||Standard Deviation|Mean
1365013|NCT01626118|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0."|0-4 hours||||units on a scale*hour||Standard Deviation|Mean
1365014|NCT01626118|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
1365015|NCT01626118|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
1365016|NCT01626118|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-4 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
1365018|NCT01626092|Secondary|Neurologic Outcomes|Depending upon underlying primary disease, a combination of evaluative tools (e.g. brain magnetic resonance imaging (MRI), clinical neurologic exam, neuropsychologic testing, electromyography) will be applied for assessment of neurologic function and how it may be affected by this reduced-intensity HCT regimen.|Changes from Baseline, Days 30, 60, 100, Year 1, Year 2, Year 3 Following HCT|None of the 3 patients enrolled in the study were evaluable for this outcome. Two had a repeat transplant and one was lost to follow-up.||||||
1365019|NCT01626092|Secondary|Transplant-Related Mortality|Incidence of death due to complications of HCT following this reduced-intensity conditioning regimen.|Day 100 following HCT||||participants|||Number
1365028|NCT01625845|Primary|Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 weeks||||Change in Total Score||Standard Error|Mean
1365029|NCT01625845|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation|0 and 12 weeks||||% change in brachial diameter||Standard Error|Mean
1365030|NCT01625689|Secondary|Viral Etiologies of Acute Respiratory and Febrile Illness Will be Parameterized as the Percentage of Those With Each Particular Laboratory-confirmed Respiratory Virus Infection Categorized by Vaccine Allocation||6 months post-vaccination|||||||
1365031|NCT01625689|Secondary|Clinical Characteristics of Influenza, Including Influenza Coinfections With Other Bacterial and Viral Respiratory Pathogens, Will be Parameterized as the Percentage of Participants Categorized by Vaccine Allocation||6 months post-vaccination|||||||
1365032|NCT01625689|Secondary|Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day.||2, 4, and 7 days post-vaccination|||||||
1365033|NCT01625689|Secondary|The Post-vaccination Anti-influenza Immunologic Response Will be Measured Based on the Type of Immunologic Assay and Categorized by Vaccine Virus Strain, Participant Baseline Serostatus, and Vaccine Allocation||Approximately 21 days post-vaccination|||||||
1365034|NCT01625689|Primary|Percentage of Participants With Solicited Local and Systemic Reactions|"Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain~Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy"|Through 7 days following vaccination|Safety analysis population|||percentage of participants|||Number
1365035|NCT01625689|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)||Throughout study period, through at least 6 months following vaccination||||percentage of participants|||Number
1365036|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician~Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)~Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|42 days following vaccination|||||||
1365037|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician~Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)~Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|6 months following vaccination|Safety analysis population|||participants|||Number
1365038|NCT01625507|Secondary|Change in Waist Circumference|Measured using repeated 24 hour dietary recalls (pre and post-intervention|4 months||||cm||95% Confidence Interval|Mean
1365039|NCT01625507|Secondary|Food Availability|questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.|4 months|||||||
1365040|NCT01625507|Secondary|Food Accessibility|questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes|4 months|||||||
1365041|NCT01625507|Secondary|Food Acceptability|questionnaire based on items related to personal and cultural acceptability of the recommended diet|4 months|||||||
1365042|NCT01625507|Secondary|Change in Perceived Dietary Adherence Questionnaire Score|Questionnaire assessing self-reported adherence to 9 criteria, whose individual scores (range 0-7) are summed to get the total score. Maximum total score is 63. Minimum total score is 0. A higher score means higher dietary adherence.|4 months||||units on a scale||95% Confidence Interval|Mean
1365043|NCT01625507|Secondary|Change in Blood Biomarkers|blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol|4 months||||mg/dL||95% Confidence Interval|Mean
1365044|NCT01625507|Secondary|Body Composition|body fat and fat-free mass|3 months||||percentage change from baseline||95% Confidence Interval|Mean
1365045|NCT01625507|Secondary|Change in Body Mass Index|Actual weight and height used to calculate BMI pre- and post-intervention|4 months||||kg/m2||95% Confidence Interval|Mean
1365046|NCT01625507|Secondary|Program Retention|attendance at meetings|3 months||||Participants|||Count of Participants
1365047|NCT01625507|Secondary|Change in Hemoglobin A1c|a surrogate of blood glucose control|4 months||||percentage of hemoglobin A1c||95% Confidence Interval|Mean
1365048|NCT01625507|Primary|Change in Nutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months||||grams||95% Confidence Interval|Mean
1365049|NCT01625507|Primary|Change in Macronutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months||||percentage of total energy||95% Confidence Interval|Mean
1365050|NCT01625507|Primary|Change in Total Energy Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|4 months|All participants, intention to treat protocol|||kcal||95% Confidence Interval|Mean
1365051|NCT01625455|Secondary|Quality of Life|"The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI).~For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life.~Maximum response for all ten questions 30, minimum 0."|one week||||scores on a scale||Standard Deviation|Mean
1365052|NCT01625455|Primary|Severity of Pruritus|The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.|one week||||units on a scale||Standard Deviation|Mean
1365053|NCT01625416|Secondary|Physical Functioning|The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. No other subscales will be used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1365054|NCT01625416|Secondary|Alcohol Use Problems|The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1365055|NCT01625416|Primary|Feasibility/Acceptability of Intervention|The investigators used laptop tracking software to assess number of patients using laptops.|Baseline to 6 months||||Participants|||Count of Participants
1365056|NCT01625416|Primary|Technology Use|The investigators used laptop tracking software to determine technology usage.|Baseline to 6 months||||minutes||Standard Deviation|Mean
1365057|NCT01625416|Primary|Change in Depression Symptoms Over the Course of the Six Months After Injury|The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1365058|NCT01625416|Primary|Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury|The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
1365059|NCT01625377|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation|Baseline was Day 28 visit. This endpoint reports patients with total adverse events (any), serious adverse events, death and premature discontinuation.|Baseline to 24 weeks|The safety population included all randomized patients who received at least one dose of study treatment post-randomization and for whom there was a post-treatment safety assessment.|||Patients|||Number
1365060|NCT01625377|Secondary|Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System|"Kidney disease outcomes quality initiative (K/DOQI) classification is based on glomerular filtration rate (GFR), abbreviated MDRD formula (mL/min/1.73m^2) :~Stage 1 : GFR >= 90; Stage 2 = GFR was between 60-89; Stage 3 = GFR was between 30-59 ; Stage 4 = GFR was between 15-29; Stage 5 = GFR was < 15 (or dialysis)"|At Week 24|ITT population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available.|||Patients|||Number
1365061|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula|"GFR estimated by using the Chronic kidney disease- epidemiology (CKD-EPI) formula:~eGFR (mL/min/1.73m^2) = 141 * min(C/K,1)^ α * max(C/K,1)^-1.209 * 0.993^A * 1.1018 (if male) * 1.159 (if black) where C = serum creatinine (in mg/dL) ; A = Age (in years); K = 0.7 for women and 0.9 for men; α = -0.329 for women and -0.411 for men. Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Deviation|Mean
1365062|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula|"Change in glomerular filtration rate was calculated using the MDRD abbreviated formula.~GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Deviation|Mean
1365063|NCT01625377|Secondary|Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula|Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit.|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Deviation|Mean
1365064|NCT01625377|Secondary|Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio|Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit.|Baseline, week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom urine protein and creatinine value at day 28 and a posterior value were available. LOCF applied.|||mg/mmol||Standard Deviation|Mean
1365176|NCT01624194|Secondary|Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.||Up to 4 weeks|Data were not not collected for this outcome.||||||
1365065|NCT01625377|Secondary|Change From Baseline (Randomization) in Serum Creatinine|"Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function.~Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||µmol/L||Standard Deviation|Mean
1365066|NCT01625377|Secondary|Number of Patients With Death or Graft Loss|The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft.|at week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.|||Patients|||Number
1365067|NCT01625377|Secondary|Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3|"Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.~The patients with treated or untreated BPAR having RAI score > 3 were reported in this end point."|At 24 weeks|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.|||Patients|||Number
1365068|NCT01625377|Secondary|Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification|"Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.~The severity of BPAR was categorized as :~Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted."|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.|||Patients|||Number
1365069|NCT01625377|Secondary|Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR)|Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.|||Patients|||Number
1365070|NCT01625377|Secondary|Number of Patients With Treatment Failures|"Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification >3, graft loss or death at 6 months.~Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.~The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft."|At week 12 and week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.|||Patients|||Number
1365071|NCT01625377|Primary|Change From Baseline (Randomization) in Renal Function|"Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula.~GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value a Day 28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1365072|NCT01625338|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1365073|NCT01625338|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1365074|NCT01625338|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
1365075|NCT01625338|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1365177|NCT01624194|Secondary|Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.||Baseline; Week 4|Data not collected.||||||
1365076|NCT01625338|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
1365077|NCT01625221|Primary|Reduction in Fecal Incontinence Symptoms|Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.|12 Months||||episodes per week||Standard Deviation|Mean
1365078|NCT01625221|Primary|Adverse Events|The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.|60 months|All adverse events as reported by investigators|||Number of events|||Number
1365079|NCT01625182|Secondary|Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)|This questionnaire was constructed using the patients’ perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.|||score on a scale||95% Confidence Interval|Least Squares Mean
1365080|NCT01625182|Secondary|Change From Baseline for Grip Strength, Non-dominant Hand|Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.|||kPa||95% Confidence Interval|Least Squares Mean
1365081|NCT01625182|Secondary|Change From Baseline for Grip Strength, Dominant Hand|Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.|||kPa||95% Confidence Interval|Least Squares Mean
1365082|NCT01625182|Primary|Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale|Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.|Month 12|The full analysis set, which included all participants who were assigned randomly to receive treatment, was analyzed.|||Days||95% Confidence Interval|Median
1365083|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 14|One participant did not complete D14 visit.|||participants|||Number
1365084|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 5|One participant did not complete Visit D5.|||participants|||Number
1365085|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 14|One participant did not complete D14 visit.|||ng*hr/ml||Standard Deviation|Mean
1365086|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 5|One participant did not complete D5 visit.|||ng*hr/ml||Standard Deviation|Mean
1365087|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 14: 0, 2,4, 8 and 24 hours post dose|One participant did not complete D14 visit.|||ng*hr/ml||Standard Deviation|Mean
1365088|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 5: 0, 2,4, 8 and 24 hours post dose|One participant did not complete Day 5 visit.|||ng*hr/ml||Standard Deviation|Mean
1365089|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.|||ng/ml||Standard Deviation|Mean
1365090|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.|||ng/ml||Standard Deviation|Mean
1365091|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|"Cmax ng/ml~Note: One participant did not complete the Day 5 evaluation."|day 5|Note: One participant did not complete the Day 5 evaluation.|||ng/ml||Standard Deviation|Mean
1365092|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|"Cmax ng/ml~Note: One participant did not complete the Day 5 evaluation."|Day 5|Note: One participant did not complete the Day 5 evaluation.|||ng/ml||Standard Deviation|Mean
1365093|NCT01625104|Primary|Percentage of Sites With Reduction in Door to Balloon Time|"Arrival time in Emergency Department to first balloon inflation in the coronary artery.~Any reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time"|Arrival to balloon inflation, measured in minutes (generally less than 120 mins)||||percentage of sites with improved D2B|||Number
1365094|NCT01625091|Secondary|Craving for Alcohol|Self-reported scale of alcohol craving ranging from 0 (no craving) to 10 (strongest craving)|4 months||||units on a scale||Standard Deviation|Mean
1365095|NCT01625091|Secondary|Drinking Problems (SIP-2R Score)|The Short Inventory of Problems (SIP-2R) seeks to measure the consequences of drinking in participants through questions related to guilt, reliability etc. The SIP-2R has 15 items asking how often the event happened during the past 3 months. Each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). The 15 questions from the SIP-2R are summed to create a total range of scores from 0-45.|4 months||||units on a scale||Standard Deviation|Mean
1365096|NCT01625091|Secondary|Number of Binge Drinking Days|In the past 30 days, total number of days with binge drinking which was defined as consuming ≥4 drinks on a single day (measured by Timeline Follow Back).|Month 4||||Days||95% Confidence Interval|Median
1365097|NCT01625091|Primary|Number of Participants Who Quit Hazardous Drinking|The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and <4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .|Month 4||||Participants|||Count of Participants
1365098|NCT01624948|Secondary|Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes|"Measurement of the expression of three NFAT-regulated genes IL-2, interferon gamma, and GM-CSF, to predict a rejection episode.~The residual gene expression after Tacrolimus intake was calculated as T1.5/T0*100, where T0 is the adjusted number of transcripts at Tacrolimus pre-dose level and T1.5 is the number of transcripts 1.5 hours after drug intake. For all three genes the residual expression was averaged and presented as “MRE of NFAT-regulated genes.”"|3 months post-randomization|a subset of 19 participants enrolled in the immune-monitoring portion of the study|||percent residual expression||95% Confidence Interval|Median
1365099|NCT01624948|Secondary|Proteinuria||3 months post-randomization||||g/g creatinine||Standard Deviation|Mean
1365100|NCT01624948|Secondary|Cholesterol||3 months post-randomization||||mg/dL||Standard Deviation|Mean
1365101|NCT01624948|Secondary|p70S6 Kinase Phosphorylation||3 months post-randomization|19 patients enrolled in the immune-monitoring subset; 1 participant did not have a 3-month assay.|||Mean Fluorescence Intensity||95% Confidence Interval|Median
1365102|NCT01624948|Secondary|Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels|A doubling of BK viremia levels or the development of BKV nephropathy in subjects enrolled in the experimental study arm will prompt a conversion to standard care therapy. We will closely monitor BKV levels in the urine and blood and assess renal function monthly, as per our usual standard of care. Based on BKV results as well as renal function, as assessed by serum Cr, biopsies may be done for cause. Patients will have a final visit at month 4 to monitor for adverse events.|3 months post-randomization||||participants|||Number
1365103|NCT01624948|Primary|Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia|composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization|3 months post-randomization||||participants|||Number
1365104|NCT01624870|Secondary|Combined Safety Endpoint|The Kaplan-Meier rate of all-cause mortality, major stroke, life threatening (or disabling) bleeding, acute Kidney Injury - Stage 3 (including renal denervation therapy), peri-procedural myocardial infarction or repeat procedure for valve related dysfunction (surgical or interventional). A Kaplan Meier assessment was used to determine the composite rate.|30 days post procedure|All implanted|||Percentage of subjects, Kaplan-Meier|||Number
1365105|NCT01624870|Primary|New-onset Class I or II Indication for Permanent Pacemaker Implantation|The Kaplan-Meier rate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or >6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.|30 days post procedure|the populations used for this parameter are sub-population of the 194 implanted subjects for whom data of implant depth was available|||Percentage of subjects, Kaplan-Meier||95% Confidence Interval|Number
1365106|NCT01624740|Primary|Change in Back Pain Intensity|"Back pain intensity was measured on a 0-10 numerical rating scale (0=no pain, 10=worst pain imaginable) at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation."|For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).||||Percent Change From Baseline||Standard Deviation|Mean
1365107|NCT01624467|Secondary|Number of Participants With an Incidence of Anti-Necitumumab Antibodies||Baseline to Post Infusion 30 Day Follow-up|All participants who received at least 1 dose of study drug and had at least 1 post-infusion blood sample.|||participants|||Number
1365108|NCT01624467|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1,CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.|Baseline to Measured Progressive Disease (up to 21 Months)|All participants who received any study drug and had CR or PR.|||percentage of participants||95% Confidence Interval|Number
1365109|NCT01624467|Secondary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab||Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1, Days 1 and 36.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1365110|NCT01624467|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞])||Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1 on Days 1 and 36.|||microgram*hour/milliliter (μg*h/ml)||Geometric Coefficient of Variation|Geometric Mean
1365111|NCT01624467|Secondary|Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR])|Change in HR from time-matched measures performed at baseline.|Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG|||Beats/minute||Standard Deviation|Mean
1365112|NCT01624467|Secondary|PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.|||percentage of participants|||Number
1365113|NCT01624467|Secondary|Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG|||participants|||Number
1365114|NCT01624467|Primary|Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)|The corrected QT interval was calculated using Fridericia’s correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant’s corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval|Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.|||milliseconds (msec)||90% Confidence Interval|Mean
1365115|NCT01624363|Primary|Prevalence of Pancreatic Cysts During Routine EUS|The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .|48 months||||participants found to have a cyst|pancreas'|95% Confidence Interval|Median
1365116|NCT01624350|Secondary|Pain|Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.|Baseline, 1 month, 3 months, 6 months and 12 months|Participants include number of patients who completed questionnaire|||Participants|||Count of Participants
1365117|NCT01624350|Secondary|Patient Satisfaction Between the First and Last Post-operative Visit|Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.|Between the first and last visits|Number of participants completed a satisfaction questionnaire at least twice.|||Participants|||Count of Participants
1365118|NCT01624350|Secondary|Fecal Incontinence|Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.|3 months, 6 months and 12 months|The CCF-FI score was calculated if a score was ticked for each of the five types of incontinence. If a patient had a type of incontinence with a missing score, then the CCF-FI score was not calculated. Change = Value and Month X - Value at Baseline.|||units on a scale||Standard Deviation|Mean
1365119|NCT01624350|Secondary|Participant Response to Quality of Life EQ-5D Questionnaire|Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.|Baseline, and 3 months, 6 months and 12 months post op|Number analyzed include participants who completed questionnaire.|||participants|||Number
1365120|NCT01624350|Secondary|Fistula Healing in Patients at 3 and 12 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|3 months and 12 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.|||percentage of patients||95% Confidence Interval|Number
1365121|NCT01624350|Primary|Fistula Healing in Patients at 6 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|6 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.|||percentage of participants|||Number
1365122|NCT01624259|Secondary|Percent Change From Baseline in Lipid Parameters at 26 Weeks|A summary of percent change in lipid parameters (total cholesterol, high-density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], very low-density lipoprotein cholesterol [VLDL], and triglycerides) from baseline to primary endpoint of 26 weeks is presented. LS means of the lipid parameter from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and lipid parameter baseline as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipid laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percent||Standard Error|Least Squares Mean
1365123|NCT01624259|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose|LY2189265 (dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation in dulaglutide-treated participants. A participant was considered to have treatment emergent LY2189265 ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The number of participants with treatment-emergent LY2189265 ADA from postbaseline to follow up were summarized.|Baseline up to 4 Weeks Post Last Dose of Study Drug|Participants who were randomized and received at least 1 dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
1365178|NCT01624194|Secondary|Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.||Up to 4 weeks|Data were not collected for this outcome.||||||
1365124|NCT01624259|Secondary|Number of Participants With Allergic or Hypersensitivity Reactions|Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adverse event data.|||participants|||Number
1365125|NCT01624259|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.|||weeks||95% Confidence Interval|Median
1365126|NCT01624259|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|HE were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). The hypoglycemia rate per 30 days was calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemic episode data. Only pre-rescue measurements were used.|||number of events/participant/30 days||Standard Deviation|Mean
1365127|NCT01624259|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.|||percentage of participants|||Number
1365128|NCT01624259|Secondary|Percentage of Participants With Self-Reported Hypoglycemia Events|"Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a plasma glucose [PG] concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL).~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemia event data. Only pre-rescue measurements were used.|||percentage of participants|||Number
1365129|NCT01624259|Secondary|Change From Baseline in Amylase at 26 Weeks|A summary of participants having changes in amylase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable amylase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||U/L||Inter-Quartile Range|Median
1365130|NCT01624259|Secondary|Change From Baseline in Lipase at 26 Weeks|A summary of participants having changes in lipase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units/liter (U/L)||Inter-Quartile Range|Median
1365131|NCT01624259|Secondary|Change From Baseline in Calcitonin at 26 Weeks|A summary of participants having changes in calcitonin values from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable calcitonin laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms/milliliter (pcg/mL)||Inter-Quartile Range|Median
1365132|NCT01624259|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 26 weeks (including a 30-day follow up). Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline up to 30 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable adverse event data.|||participants|||Number
1365133|NCT01624259|Secondary|Change From Baseline in Blood Pressure (BP) at 26 Weeks|Descriptive statistics for the actual measurements and change from baseline for sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline BP as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BP data.|||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
1366274|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Extension Test|Change from baseline to Week 25 and 52 as measured by the peak force in MST knee extension test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
1365134|NCT01624259|Secondary|Change From Baseline in Heart Rate (HR) at 26 Weeks|Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the MMRM model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable heart rate data.|||bpm||Standard Error|Least Squares Mean
1365135|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QTcF is the measure of the time between the start of the Q wave and the end of the T wave adjusted using Fridericia's formula. PR is the interval between the P wave and the QRS complex. These parameters were calculated from electrocardiogram (ECG) data. LS means of change from baseline for the PR and QTcF intervals will be analyzed using the MMRM similar to MMRM model for primary outcome, using corresponding baseline and HbA1c strata. Only ECGs obtained at scheduled visits will be used in these summaries and analyses.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable ECG PR or QTcF interval data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milliseconds (msec)||Standard Error|Least Squares Mean
1365136|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks|ECG HR was measured. LS means of change from baseline were analyzed using ANCOVA with HbA1c strata, country, and treatment as fixed effects and baseline HR as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable ECG heart rate data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1365137|NCT01624259|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular (CV) adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal CV AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with reported CV events, number of participants with nonfatal CV events confirmed by adjudication, and number of deaths confirmed by adjudication are summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adjudicated CV event data.|||participants|||Number
1365138|NCT01624259|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks|"The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%.~LS means of the HOMA2-%B change from baseline to primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline HOMA2-%B value as covariate, via an ANCOVA analysis using LOCF."|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable HOMA2-%B data. LOCF was used to impute missing postbaseline values. If there was no data after date of randomization, the endpoint was considered missing.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
1365139|NCT01624259|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks|The percentage of participants who achieved the target HbA1c values at the primary endpoint were analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes pooled country, treatment, visit, treatment-by-visit interaction, and baseline HbA1c as continuous covariates.|Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1365140|NCT01624259|Secondary|Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks|"The SMPG data were collected at the following 7 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; and bedtime. The mean of the 7 time points (Daily Mean) was also calculated.~LS means of the SMPG change from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, HbA1c strata, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG as a covariate, via a MMRM analysis using REML."|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable 7-Point SMPG data. Only pre-rescue measurements were used.|||mg/dL||Standard Error|Least Squares Mean
1365141|NCT01624259|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks|LS means of the FPG from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FPG as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|"Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable FPG data. Only pre-rescue measurements were used.~LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing."|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1365142|NCT01624259|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means of the BMI change from baseline to primary endpoint at Week 26 were calculated using ANCOVA with HbA1c Strata, country, and treatment as fixed effects and baseline BMI as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BMI data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||kilograms/square meter (kg/m^2)||Standard Error|Least Squares Mean
1365143|NCT01624259|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means of the weight change from baseline to primary endpoint at Week 26 were calculated using analysis of covariance (ANCOVA) with HbA1c Strata, country, and treatment as fixed effects and baseline body weight as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1365144|NCT01624259|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1365145|NCT01624233|Secondary|Number of Participants Achieving ACR20|ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR.|Wk 100 and Wk 292||2018-09-30|09/2018||||
1365146|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain VAS|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 100; Baseline, Wk 292||2018-09-30|09/2018||||
1365147|NCT01624233|Secondary|Change From Baseline in DLQI Score|DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant.|Baseline, Wk 100; Baseline, Wk 292||2018-09-30|09/2018||||
1365148|NCT01624233|Secondary|Change From Baseline in Itch NRS Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 100; Baseline, Wk 292||2018-09-30|09/2018||||
1365149|NCT01624233|Secondary|Change From Baseline in QIDS-SR16 Score|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 100; Baseline, Wk 292||2018-09-30|09/2018||||
1365150|NCT01624233|Secondary|Change From Baseline in PSSI|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 100; Baseline, Wk 292||2018-09-30|09/2018||||
1365151|NCT01624233|Secondary|Change From Baseline in NAPSI|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.|Baseline, Wk 100; Baseline, Wk 292||2018-09-30|09/2018||||
1365152|NCT01624233|Secondary|Change From Baseline in Percent of BSA Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 100; Baseline, Wk 292||2018-09-30|09/2018||||
1365153|NCT01624233|Secondary|Percentage of Participants With sPGA (0 or 1) and sPGA (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wks 100 and 292||2018-09-30|09/2018||||
1365154|NCT01624233|Secondary|Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 100 and 292||2018-09-30|09/2018||||
1366349|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 22|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22||||units on a scale||Standard Deviation|Mean
1365155|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 12; Baseline, Wk 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.|||mm||Standard Deviation|Mean
1365156|NCT01624233|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).|Wks 12, 24 and 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.|||participants|||Number
1365157|NCT01624233|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score|DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1365158|NCT01624233|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS) Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1365159|NCT01624233|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1365160|NCT01624233|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1365161|NCT01624233|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
1365162|NCT01624233|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).|||percentage of BSA||Standard Deviation|Mean
1365179|NCT01624194|Secondary|Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.|Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160.|Baseline; Week 4|Participants with available data are included.|||units on a scale||Standard Deviation|Mean
1365163|NCT01624233|Secondary|Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.|||percentage of participants|||Number
1365164|NCT01624233|Secondary|Percent of Participants Achieving PASI 90% and 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.|||percentage of participants|||Number
1365165|NCT01624233|Secondary|Number of Participants With Anti-Ixekizumab Antibodies|Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.|Baseline through Wk 52|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.|||participants|||Number
1365166|NCT01624233|Secondary|Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab|PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.|Wks 12 and 24|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1365167|NCT01624233|Secondary|Percentage of Participants Achieving ≥75% Improvement in PASI|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.|||percentage of participants|||Number
1365168|NCT01624233|Primary|Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week (Wk) 12|All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1365169|NCT01624194|Secondary|Change From Baseline in Blood Pressure||Baseline; Week 4|Participants with available data are included in the analysis.|||mmHg||95% Confidence Interval|Least Squares Mean
1365170|NCT01624194|Secondary|Change From Baseline in Heart Rate||Baseline; Week 4|Participants with available data are included in the analysis.|||beats per minute||95% Confidence Interval|Least Squares Mean
1365171|NCT01624194|Secondary|Change From Baseline in Weight||Baseline; Week 4||||kilograms||95% Confidence Interval|Least Squares Mean
1365172|NCT01624194|Secondary|Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.|Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)|Baseline; Week 4|Only analyzed after 4 weeks.|||units on a scale||Standard Error|Least Squares Mean
1365173|NCT01624194|Secondary|Change From Baseline in Plasma Oxytocin Levels During Treatment.|"This outcome originally specified that oxytocin, vasopressin, and cortisol levels would be assessed; however, data on vasopressin and cortisol levels were not collected during the study.~There are no clinical laboratory tests that establish a normative range for oxytocin. Measurements prior to and following treatment were intended to evaluate oxytocin level as a predictor of response."|Up to 4 weeks|Participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
1365174|NCT01624194|Secondary|Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.|"Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities.~Scores can range from 1 to 19."|Baseline; Week 4|Participants with available data were included.|||units on a scale||Standard Deviation|Mean
1365175|NCT01624194|Secondary|Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.||Up to 4 weeks|Data were not not collected for this outcome.||||||
1365180|NCT01624194|Secondary|Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.|Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)|Baseline; Week 4|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365181|NCT01624194|Secondary|Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4|Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.|Baseline; Week 4|Participants with available data are included.|||units on a scale||Standard Deviation|Mean
1365182|NCT01624194|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at Week 4|This outcome is reported as the count of participants in each CGI-I rating category at the week 4 visit, assessing change over the 4-week period. CGI-I rating of 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.|Baseline to Week 4|Participants with available data are included.|||Participants|||Count of Participants
1365183|NCT01624194|Secondary|Change From Baseline in Height.||Baseline; Week 4|Participants with available data are included in the analysis.|||cm||95% Confidence Interval|Least Squares Mean
1365184|NCT01624194|Secondary|Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment|Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.|Baseline through Week 4||||participants|||Number
1365185|NCT01624194|Primary|Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.|Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)|Baseline; Week 4|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365186|NCT01624168|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index Scores|Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.|baseline, 4 weeks, 10 weeks, 2 month follow-up||||units on a scale||Standard Error|Mean
1365187|NCT01624168|Secondary|Change From Baseline in State Anxiety Scores|Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.|change from baseline to 4 weeks, 10 weeks, 2 month follow-up||||units on a scale||Standard Error|Mean
1365188|NCT01624168|Primary|Adherence to Practice After the Intervention|Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.|2 months||||participants|||Number
1365189|NCT01624168|Primary|Adherence to Out-of-class Practice|Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention|10 weeks||||participants|||Number
1365190|NCT01624168|Primary|Retention of Randomized Subjects for Follow-up|Subjects retained for follow-up are those willing to respond to follow-up assessments|2 months||||participants|||Number
1365191|NCT01624168|Primary|Retention of Randomized Subjects During Intervention|Retained subjects are those who are willing to return for complete assessments|10 weeks||||participants|||Number
1365192|NCT01623869|Secondary|OS|Overall survival (OS) is the duration of time from the date of registration/randomization to the date of death or the date of last follow-up for patients who remain alive or who are lost to follow-up at the time of the analysis. Kaplan-Meier methodology will be used to estimate the distribution of OS.|From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months||||months||95% Confidence Interval|Median
1365193|NCT01623869|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) is defined as the duration of time from the start of treatment to time of radiologic or clinical progression or death, whichever occurs first. PFS will be censored at most recent radiographic assessment date for patients remaining alive at the time of the statistical analysis. Kaplan-Meier methodology will be used to estimate the distribution of PFS.|From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months||||months||95% Confidence Interval|Median
1365194|NCT01623869|Primary|Confirmed Response Rate (CR or PR) Using RECIST|"Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response.~Complete Response (CR) - All of the following must be true:~Disappearance of all target and non-target lesions,~Each target lesion and non-target lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR):~At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation.~Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner."|Up to 18 months||||percentage of participants||95% Confidence Interval|Number
1365195|NCT01623830|Secondary|State Trait Anxiety Inventory- Trait (STAI-Trait)|The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety. Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
1365196|NCT01623830|Secondary|State Trait Anxiety Inventory- State (STAI-State)|The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety.Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
1366350|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 18|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18||||units on a scale||Standard Deviation|Mean
1365197|NCT01623830|Secondary|The Beck Depression Inventory (BDI)|a 21-item measure of cognitive and vegetative symptoms of depression is widely used in a variety of populations, including trauma victims and is sensitive to treatment effects on depression. The possible range for scores is 0-63 with higher scores suggesting more severe symptoms of depression.|post-treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
1365198|NCT01623830|Primary|The Questionnaire on Attitudes Toward Flying (QAF)|assesses history of FOF, previous treatment, and attitudes toward flying. It includes a 36-item questionnaire rating the level of fear on an 11-point scale ranging from 0 to10 in different flying situations. The possible range of scores is 0 to 360 with higher scores indicating greater fear associated with flying. Test-retest reliability was .92, and split-half reliability was .99.|post treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
1365199|NCT01623830|Primary|Fear of Flying Inventory (FFI)|a 33-item scale measuring intensity of FOF. Items are rated on a 9-point scale ranging from 0 ( not at all) to 8 ( very severely disturbing). The possible range of scores is 0-264 with higher total scores indicating greater fear of flying intensity.Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment.|Post treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
1365200|NCT01623739|Secondary|Radiographic Bone Level|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline|||||||
1365201|NCT01623739|Secondary|Modified Bleeding Index|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline|||||||
1365202|NCT01623739|Secondary|Modified Plaque Index|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline|||||||
1365203|NCT01623739|Secondary|Probing Depth|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline|||||||
1365204|NCT01623739|Secondary|PES/WES (Pink Esthetic Score, White Esthetic Score).|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline|||||||
1365205|NCT01623739|Primary|Mid Facial Mucosal Level at Implant Site|Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|3 months after crown delivery||||mm||Standard Deviation|Mean
1365206|NCT01623596|Secondary|Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score|Summary statistics for Medication Satisfaction Questionnaire[Question: “Overall, how satisfied are you with your current medication?”] (Randomized treatment / randomized phase): Fingolimod vs MS-DMT|Baseline, 1 month, 3 months, 6 months, 9 months, at 12 months & Last assessment during randomized phase which is either at Month 12 or at early discontinuation|Full analysis set (FAS) includes all the patients who received at least one dose of study medication and had information on the primary end point.|||participants|||Number
1365207|NCT01623596|Secondary|Percent Change From in Brain Volume From Month 12 to Last Visit (Randomized)|Summary statistics for percent change from month 12 in brain volume by visit (Randomized treatment / randomized phase) in patients treated with fingolimod vs.DMTs as measured by MRI|12 months, and Last assessment which is either at Month 12 or at early discontinuation|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||percent change in brain volume||Standard Deviation|Mean
1365208|NCT01623596|Secondary|Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)|"Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons~The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.~NOTE: Higher scores indicate better performance."|baseline, 6 months, 12 months, Last assessment which is either at Month 12 or at early discontinuation|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||SDMT score||Standard Deviation|Mean
1365209|NCT01623596|Secondary|Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)|"Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons~The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.~NOTE: Higher scores indicate better performance."|baseline, 6 months, 12 months, and Last assessment which is either at Month 12 or at early discontinuation|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||SDMT score||Standard Deviation|Mean
1365227|NCT01623271|Primary|Visual Analog Scale (VAS) at Visit 3|Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3.|At visit 3|Only 3 subjects completed visit 3. The other 2 subjects dropped out due to expected side effects.|||units on the VAS||Standard Deviation|Mean
1365243|NCT01623115|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On- Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
1365210|NCT01623596|Secondary|Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set|"Reasons for discontinuation in participants treated with fingolimod vs. DMT over 12 months of treatment~Total discontinued (Primary reason): Fingolimod arm: 27, MS-DMT arm: 27 = 54 participants~Total discontinued (Secondary reason): Fingolimod arm: 257, MS-DMT arm: 256 = 513 participants~Throughout the study, investigators evaluated each patient for occurrence of randomized treatment discontinuation and determined the primary and secondary reasons for such discontinuation. At every visit, the investigator evaluated the patients and determined if they should continue on randomized treatment or change to alternative treatment. Treatment discontinuation was a clinically meaningful measure related to safety, efficacy, and tolerability over time, reflecting the therapeutic effectiveness of study treatment."|at 12 months|"Randomized set (RS): consists of all patients who were assigned randomization numbers.~The patients in this set were called randomized patients. This set was used to summarize patient disposition, demographic and baseline characteristics, and protocol deviation information. Patients were grouped according to randomized treatment."|||participants|||Number
1365211|NCT01623596|Primary|Participant Retention Rate Over 12 Months|Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)|at 12 months|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||participants|||Number
1365212|NCT01623479|Secondary|Percentage of Subjects Satisfied Wtih Their Eyelashes|Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data|||Percentage of Subjects|||Number
1365213|NCT01623479|Secondary|Number of Applications of Latisse® Per Week|Number of applications of Latisse® per week as reported by the subjects.|Day 1|Subjects with all study data|||Number of Applications||Standard Deviation|Mean
1365214|NCT01623479|Primary|Percentage of Subjects Satisfied With Latisse®|Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data|||Percentage of Subjects|||Number
1365215|NCT01623466|Primary|Cycle Control|Measurement of unscheduled bleeding/spotting days.|8 weeks|Completed subjects|||days||Standard Deviation|Mean
1365216|NCT01623466|Primary|Evaluation of Itching at Patch Application Site|"Self-reported worst skin itching at patch application site by subject using a 4-point scale:~0. None~Mild~Moderate~Severe"|8 weeks|Safety Population|||Score||Standard Deviation|Mean
1365217|NCT01623466|Primary|Evaluation of Irritation at Patch Application Site|"Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale:~0: None~Mild~Moderate~Severe"|8 weeks|Safety population|||Score on a scale||Standard Deviation|Mean
1365218|NCT01623466|Primary|Evaluation of Patch Adhesion|"Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale:~0: ≥90% adhered (no lift)~≥75% adhered but <90% (some edges showing lift)~≥50% adhered but <75% (half of system lifts off)~<50% (< half of system lifts off, but undetached)~patch completely detached"|8 weeks|Safety population|||Score on a scale||Standard Deviation|Mean
1365219|NCT01623466|Primary|Levonorgestrel Pharmacokinetic Profile|The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.|8 weeks|Primary PK population|||% of subjects below 175 pg/mL|||Number
1365220|NCT01623323|Primary|Adverse Events|Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.|Baseline to 3 months or End of Study|All subject who received at least one dose of study medication|||participants|||Number
1365221|NCT01623310|Secondary|Nasal Polyp Surgery Eligibility||Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
1365222|NCT01623310|Secondary|Summed Bilateral Nasal Polyp Grading Scale Score|"In subjects with nasal polyps, polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy.~0: No polyps~Mild polyposis: polyps not reaching below the inferior of the middle turbinate~Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate~Severe polyposis: large polyps reaching below the lower inferior border of the inferior turbinate"|Baseline, Month 3, Month 12|Includes Chronic Sinusitis with Nasal Polyp Patients|||units on a scale||Standard Deviation|Mean
1365223|NCT01623310|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC took less than 1 minute to complete. Subjects answered question, Since starting the study drug, how would you rate the change in your symptoms? Patients may answer very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data listed below reports the total number of patients who answered very much improved, much improved, or minimally improved at the specified time."|Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
1365224|NCT01623310|Secondary|Lund-Mackay Total Score|"Change from baseline to Month 3, Month 12, in Lund-Mackay Total Score~Lund-Mackay Assessment of nasal cavity appearance, via nasoendoscopy, used to evaluate signs of edema, discharge, crusting, scarring/adhesions, and nasal polyps, with each sign rated on a 0 to 2 scale 0: None 2: Worse outcome"|Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1365225|NCT01623310|Secondary|Sinonasal Outcome Test 22 (SNOT-22) Total Score|"Change from baseline to Month 3 & Month 12 in SNOT-22 Total Score~SNOT-22 is validated in large populations with chronic sinusitis with and without nasal polyps. The 22 questions are used to calculate a total score (the sum of all items) and 4 subscale scores. The 22 questions are divided among 4 subscales: Rhinologic, Ear and Facial Symptoms, Sleep Function, and Psychological Issues subscales. The total score can range from 0-110, 0 being the best and 110 being the worst.~0: No problem~Very mild problem~Mild or slight problem~Moderate problem~Severe problem~Problem as bad as it can be"|Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1365226|NCT01623310|Primary|Adverse Events|Patients with at least one Adverse Events|12 Months||||Participants|||Count of Participants
1365228|NCT01623154|Other Pre-specified|Number of Participants Tested Positive/Negative for H. Pylori|"Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement.~UHR values of >10 µg/min were considered positive for H. pylori and UHR values of <10 µg/min were considered negative for H. pylori."|Single Study Visit (1 hour of testing)|95 evaluable subjects for initial diagnosis - each patient received the BreathTek UBT test. Collected breath samples were analyzed on both the UBiT-IR300 and the POC-one.|||Participants|||Number
1365229|NCT01623154|Primary|Agreement Between POCone and UBiT-IR300.|"The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300.~Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled A B C. Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result.~DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight)."|Baseline, Post Dose (15 min)|Evaluable patients must drink all of the Pranactin-citric solution. Though all three sets of bags were analysed, the first two sets of valid values were used for analysis, regardless of the set designation (A, B or C). The values of individual sets (A, B or C) were not analyzed.|||||95% Confidence Interval|Number
1365230|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.|||percent change||Standard Error|Least Squares Mean
1365231|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment.|From Baseline to Week 78|ITT population.|||percent change||Standard Error|Least Squares Mean
1365232|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1365233|NCT01623115|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1365234|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365235|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1365236|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365237|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
1365238|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365239|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1365240|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365241|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
1365242|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|Up to Week 52|ITT population.|||percentage of participants|||Number
1365244|NCT01623115|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
1365245|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1365246|NCT01623115|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1365247|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1365248|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1365249|NCT01623115|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on-or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1365250|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL­C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
1365251|NCT01623115|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1365252|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
1365253|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post­baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1365254|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1365255|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post­baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1365256|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1365257|NCT01623115|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
1365258|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia of 27 patients analyzed.|12 months|7 patients were lost to follow up|||percentage of ostia patent|Participants||Number
1365263|NCT01622673|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience."|Up to 7 days after the last dose of study drug|All subjects who received any amount of the study drug were included in the safety population|||participants|||Number
1365264|NCT01622673|Primary|Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir|Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||hr||Standard Deviation|Mean
1365265|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
1365266|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
1365267|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM*hr||95% Confidence Interval|Least Squares Mean
1365268|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM*hr||95% Confidence Interval|Least Squares Mean
1365269|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®.|12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
1365270|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|12 hours postdose|All participants were included for whom at least one pharmacokinetic (PK) parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
1365271|NCT01622660|Primary|Progression Free Survival (PFS)|Progression Free Survival will be calculated from the start of treatment until progressive disease or death. Patients who die before documented progression will be considered failures at their time of death. If the patient did not progress or die, the patient will be censored on the date of last follow-up. Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Measurable lesions: lesions that can be accurately measured in at least one dimension with longest diameter ≥ 10 mm by clinical exam or with spiral CT scan or MRI (no less than double the slice thickness and a minimum of 10mm). Malignant lymph nodes must be 15 mm in the short axis when assessed by spiral CT scan to be considered measurable. Non-measurable lesions: all other lesions (or sites of disease) including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm u|2 years||||days|||Number
1365272|NCT01622348|Primary|Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment|The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion|8 weeks|ITT population|||Millimeters||Standard Deviation|Mean
1365298|NCT01622231|Secondary|Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Proportion of RBCs in blood||Standard Deviation|Mean
1365273|NCT01622296|Primary|Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment|"Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 (no pain) to 100 (pain as bad as it can be)."|immediately after anesthetic injection|per protocol, in a crossover fashion, each participant received buffered lidocaine at one treatment visit and lidocaine at one treatment visit, in randomly assigned sequence.|||units on a scale||Standard Deviation|Mean
1365274|NCT01622257|Secondary|Change in Lipid Profile|Change in LDL levels was taken as the indicator of change in lipid profile|Baseline and 3 months||||mg/dl||95% Confidence Interval|Mean
1365275|NCT01622257|Secondary|Change in Serum Free Testosterone Level|Change in serum free testosterone levels|Baseline and 3 months||||pg/ml||95% Confidence Interval|Mean
1365276|NCT01622257|Secondary|Change in Insulin Resistance|Change in Fasting insulin concentration|Baseline and 3 months||||uIU/ml||95% Confidence Interval|Mean
1365277|NCT01622257|Secondary|Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.|"The Number of participants who had evidence of successful ovulation during the 3 months. Ovulation was diagnosed based on ultrasonographic folliculometry and/or luteal serum progesterone assay.Every month, folliculometry was done to count the number of antral follicles (AFC), follow follicular growth, measure dominant follicle diameter and detect occurrence of ovulation. a mid-luteal serum progesterone assay was done to confirm ovulation.~Ultrasound was performed serially till reaching preovulatory follicle(s of around 20 mm in diameter that then rupture to show a collapsed follicle in the same location with internal echoes consistent with its transformation to a corpus luteum. Progesterone assay was done using immulite 2000 apparatus chemiluminescent immunometric assay. Mid-luteal phase progesterone above 6 ng/mL was considered indicative of normal corpus. luteum function."|3 months||||participants|||Number
1365278|NCT01622257|Primary|Clinical Pregnancy Rate||9 months||||participants|||Number
1365279|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years|PK samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population. Only those participants aged >=6 to <15 years were assessed.|||participants|||Number
1365280|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years|Pharmacokinetic (PK) samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population: all participants from whom a PK sample was obtained and analyzed. Only those participants aged >=2 to <6 years were assessed.|||participants|||Number
1365281|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant’s Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant himself/herself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population|||participants|||Number
1365282|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population|||participants|||Number
1365283|NCT01622231|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge)|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 4, Week 8, and Week 12/early withdrawal|FAS Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
1365284|NCT01622231|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
1365299|NCT01622231|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||tera (10^12) cells (TI)/L||Standard Deviation|Mean
1365285|NCT01622231|Secondary|Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Three individual symptoms (eye itching, tearing, and redness) were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
1365286|NCT01622231|Secondary|Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
1365287|NCT01622231|Secondary|Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Percent change||Standard Deviation|Mean
1365288|NCT01622231|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
1365289|NCT01622231|Secondary|Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Percent change||Standard Deviation|Mean
1365300|NCT01622231|Secondary|Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||giga (10^9) cells (GI)/L||Standard Deviation|Mean
1365301|NCT01622231|Secondary|Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Grams per liter (grams/L)||Standard Deviation|Mean
1366351|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 15|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15||||units on a scale||Standard Deviation|Mean
1365290|NCT01622231|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
1365291|NCT01622231|Secondary|Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS)|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The BL value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from BL was calculated as the mean score for the entire treatment period minus the score at BL. Only those participants available at the indicated time points were assessed.|Baseline, Day 1 to Day 84|Full Analysis Set (FAS) Population: all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication.|||Scores on a scale||Standard Deviation|Mean
1365292|NCT01622231|Secondary|Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Percent change||Standard Deviation|Mean
1365293|NCT01622231|Secondary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
1365294|NCT01622231|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Millimoles (mmol)/L||Standard Deviation|Mean
1365295|NCT01622231|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Micromoles (μmol)/L||Standard Deviation|Mean
1365296|NCT01622231|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||International units (IU)/L||Standard Deviation|Mean
1365297|NCT01622231|Secondary|Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||grams/L||Standard Deviation|Mean
1366352|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 11|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11||||units on a scale||Standard Deviation|Mean
1365302|NCT01622231|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. Basophils, eosinophils, lymphocytes, monocytes, and total neutrophil counts are measured as the percentage of cells in white blood cells.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Percentage of cells||Standard Deviation|Mean
1365303|NCT01622231|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)|Safety Population: all participants who received at least one dose of medication|||participants|||Number
1365304|NCT01621802|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1365305|NCT01621802|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1365306|NCT01621802|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1365307|NCT01621802|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1365308|NCT01621802|Secondary|Number of Subjects Reporting Investigator-confirmed Rash|Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
1365309|NCT01621802|Secondary|Number of Subjects Reporting MMR Specific Solicited General Symptoms|Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
1365310|NCT01621802|Secondary|Number of Subjects Reporting Fever|Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
1365311|NCT01621802|Secondary|Number of Subjects With Solicited General Symptoms|"Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.~Analysis was done for sub-cohort 1 only."|During the 4-day (Days 0-3) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
1365312|NCT01621802|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.|During the 4-day (Days 0-3) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
1365313|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers|Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||ED50||95% Confidence Interval|Geometric Mean
1365314|NCT01621802|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL|Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365315|NCT01621802|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL|Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365316|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||EU/mL||95% Confidence Interval|Geometric Mean
1365317|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
1365318|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Pertactin (PRN)|"Booster response was defined as:~For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.~For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365319|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)|"Booster response was defined as:~For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.~For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365320|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)|"Booster response was defined as:~For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.~For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365332|NCT01621776|Primary|The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.|"Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.~The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona."|averaged over 5 days|Post-Prandial Blood Glucose Values [Within 90 minutes following the completion of participant lunch]|||mg/dl||Standard Deviation|Mean
1365321|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)|"Booster response was defined as:~For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.~For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365322|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations|Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
1365323|NCT01621802|Secondary|Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365324|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
1365325|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||EU/mL||95% Confidence Interval|Geometric Mean
1365326|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days after vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
1365327|NCT01621802|Primary|Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365328|NCT01621802|Primary|Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365329|NCT01621802|Primary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
1365330|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast|Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days||||mg/dl||Standard Deviation|Mean
1365331|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner|Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days||||mg/dl||Standard Deviation|Mean
1365361|NCT01621178|Secondary|Percentage of Participants With Estimated Average Glucose <154 mg/dL|Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).|52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
1365333|NCT01621672|Primary|Progression Free Survival (PFS)|"Progression was defined as any one or more of the following:~Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or~Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or~If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or~Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or~New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma."|2 years||||percentage of participants|||Number
1365334|NCT01621633|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse events, serious adverse events and death were monitored from screening to end of study|From the screening visit until Day 5|Safety set: The safety set includes all participants who received study treatment.|||Participants|||Number
1365335|NCT01621633|Primary|Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set|||ng/mL||Standard Deviation|Mean
1365336|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set|||ng*hr/mL||Standard Deviation|Mean
1365337|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set: The PK analysis set included all subjects with at least one available, valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug, and experienced no protocol deviations with relevant impact on PK data.|||ng*hr/mL||Standard Deviation|Mean
1365338|NCT01621477|Secondary|Number of Participants With Transplant Related Mortality (TRM)|The number of participants who died due to TRM in the first 100 days post-transplant is given.|100 days post transplant||||participants|||Number
1365339|NCT01621477|Secondary|Incidence and Severity of Chronic Graft Versus Host Disease (GVHD)|The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.|100 days post transplant||||participants|||Number
1365340|NCT01621477|Secondary|Incidence and Severity of Acute Graft Versus Host Disease (GVHD)|The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|100 days post transplant||||participants|||Number
1365341|NCT01621477|Secondary|Disease-Free Survival (DFS)|Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.|one year post transplant||||participants|||Number
1365342|NCT01621477|Secondary|Event-Free Survival (EFS)|Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.|one year post transplant||||participants|||Number
1365343|NCT01621477|Secondary|Incidence of Malignant Relapse|Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.|One year post transplantation.||||participants|||Number
1365344|NCT01621477|Primary|One-year Survival (OS)|Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.|One year post transplant||||participants|||Number
1365345|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 WPI or SS assessment.|||units on a scale||Standard Deviation|Mean
1365346|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BDI-II assessment.|||units on a scale||Standard Deviation|Mean
1365347|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 SF-36 assessment.|||units on a scale||Standard Deviation|Mean
1365348|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BPI-S or BPI-W assessment.|||units on a scale||Standard Deviation|Mean
1365349|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 FIQ assessment.|||units on a scale||Standard Deviation|Mean
1365350|NCT01621191|Secondary|Clinical Global Impression-Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 CGI-I assessment.|||units on a scale||Standard Deviation|Mean
1365351|NCT01621191|Secondary|Patient Global Impression-Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 PGI-I assessment.|||units on a scale||Standard Deviation|Mean
1365352|NCT01621191|Primary|Number of Participants Who Experienced an Adverse Event (AE)|A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 53 weeks|Enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1365353|NCT01621178|Secondary|Participants With Events of Allergic/Hypersensitivity Reactions|Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ|Baseline through 52 Weeks|All randomized participants who received at least one dose of study drug.|||participants with events|||Number
1365354|NCT01621178|Secondary|Rate of Hypoglycemic Events (HE)|HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 52 Weeks|All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used.|||Events/Participant/Year||Standard Deviation|Mean
1365355|NCT01621178|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Events (HE)|Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
1365356|NCT01621178|Secondary|Change From Baseline in Body Weight|LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used.|||kg||Standard Error|Least Squares Mean
1365357|NCT01621178|Secondary|Change From Baseline in UACR|The change from baseline in UACR|Baseline, 52 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data.|||g/kg||Inter-Quartile Range|Median
1365358|NCT01621178|Secondary|Change From Baseline in eCrCl|eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data.|||mL/min||Inter-Quartile Range|Median
1365359|NCT01621178|Secondary|Change From Baseline in eGFR|The change in eGFR by using CKD-EPI equation.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data.|||mL/min/1.73m2||Inter-Quartile Range|Median
1365360|NCT01621178|Secondary|Change From Baseline in sCr|Change from baseline in sCr levels after treatment.|Baseline, 52 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data.|||mg/dL||Inter-Quartile Range|Median
1365444|NCT01619800|Primary|Changed in Stress Test at 6 Months as Compared to Baseline|An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.|baseline and 6 months|||||||
1365362|NCT01621178|Secondary|Change in Mean Daily Insulin Lispro Dose|The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used.|||U/day||Standard Error|Least Squares Mean
1365363|NCT01621178|Secondary|Change From Baseline in FG|LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used.|||mg/dL||Standard Error|Least Squares Mean
1365364|NCT01621178|Secondary|Change From Baseline in 8-Point SMPG|The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used.|||mg/dL||Standard Error|Least Squares Mean
1365365|NCT01621178|Secondary|Percentage of Participants Whose HbA1c is <8.0%|Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).|52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
1365366|NCT01621178|Secondary|Percentage of Participants Whose HbA1c is <7.0%|Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).|52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
1365367|NCT01621178|Secondary|Change From Baseline in HbA1c|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
1365368|NCT01621178|Secondary|Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 26 Weeks|All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used.|||Events/Participant/Year||Standard Deviation|Mean
1365369|NCT01621178|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Events (HE)|Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
1365370|NCT01621178|Secondary|Change From Baseline in Body Weight|"LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.~•"|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used.|||kilogram (kg)||Standard Error|Least Squares Mean
1365371|NCT01621178|Secondary|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)|The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).|Baseline, 26 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data.|||gram/kilogram (g/kg)||Inter-Quartile Range|Median
1365372|NCT01621178|Secondary|Change From Baseline in Estimated Creatinine Clearance (eCrCl)|Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data.|||milliliter/minute (ml/min)||Inter-Quartile Range|Median
1366353|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 8|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8||||units on a scale||Standard Deviation|Mean
1365373|NCT01621178|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data.|||milliliter/minute/1.73m2 (mL/min/1.73m2)||Inter-Quartile Range|Median
1365374|NCT01621178|Secondary|Change From Baseline in Serum Creatinine (sCr)|Change from baseline in serum creatinine (sCr) levels after treatment.|Baseline, 26 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data.|||mg/dL||Inter-Quartile Range|Median
1365375|NCT01621178|Secondary|Percentage of Participants With Estimated Average Glucose <154 mg/dL|Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
1365376|NCT01621178|Secondary|Change From Baseline in Mean Daily Insulin Lispro Dose|The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used.|||Units/day (U/day)||Standard Error|Least Squares Mean
1365377|NCT01621178|Secondary|Change From Baseline in Fasting Glucose (FG)|LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used.|||milligram/deciliter (mg/dL)||Standard Deviation|Least Squares Mean
1365378|NCT01621178|Secondary|Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)|The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1365379|NCT01621178|Secondary|Percentage of Participants Whose HbA1c Was <8.0%|Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
1365380|NCT01621178|Secondary|Percentage of Participants Whose HbA1c Was <7.0%|Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used|||percentage of participants|||Number
1365381|NCT01621178|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
1365382|NCT01621126|Primary|Neurologic Complication Rate After Latarjet Procedure|Nerve palsy of any nerve(s) in the operative upper extremity.|up to 24 weeks after the procedure||||participants|||Number
1365383|NCT01621009|Primary|7-day Point Prevalence Abstinence From Smoking at 6 Months|No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.|6 months|Full intent-to-treat sample|||Number of abstinent participants|||Number
1365384|NCT01620762|Secondary|Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use|The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 52-54 weeks after randomisation.|52-54 week after randomisaiton|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||days||Standard Error|Least Squares Mean
1365385|NCT01620762|Secondary|Mean RQLQ Score in Cat-PAD Compared With Placebo|"The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (52-54 weeks after randomisation).~The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365386|NCT01620762|Secondary|Mean RMS in Cat-PAD Compared With Placebo|"Mean RMS (Rescue medication score) in Cat-PAD treatment groups compared with placebo groups.~The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 52-54 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365387|NCT01620762|Secondary|Mean Daily TOSS in Cat-PAD Compared to Placebo|"Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups~TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365388|NCT01620762|Secondary|Mean Daily TNSS in Cat-PAD Compared With Placebo|"TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365389|NCT01620762|Secondary|Mean TRSS|"Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo.~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365390|NCT01620762|Primary|Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo|"The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome.~CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3.~RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1365391|NCT01620593|Secondary|Number of Participants With Adverse Events|"The safety and tolerability of metformin with castration therapy as compared to castration therapy alone as measured by the number of subjects experiencing adverse events using CTCAE (common terminology criteria for adverse events) version 4 criteria. Grades are assigned to each adverse event where:~Grade 1 is mild symptoms Grade 2 is moderate symptoms Grade 3 is severe or medically significant but not immediately life-threatening symptoms Grade 4 is life-threatening consequences, where urgent intervention is indicated Grade 5 is death related to the adverse event"|1 year||||Participants|||Count of Participants
1365392|NCT01620593|Secondary|Treatment Failure|Progression time from randomization to the earliest disease progression defined as an increase of 20% or more as per RECIST criteria. Patients will not be removed from protocol treatment for PSA progression alone in the first 12 weeks on this study. Further rise in PSA even in the absence of deterioration of pre-existing lesions will constitute treatment failure. Adverse event leading to withdrawal related to metformin or placebo or castration treatment. Death from any cause. Patients unwillingness to continue. Patient's non-compliance with taking the study intervention - 50% or higher.|1 year|Outcome was not measured||||||
1365393|NCT01620593|Secondary|PSA Response|Complete Response for PSA measure was defined as a PSA less than or equal to 4 ng/ml or undetectable value at 7 months.|28 weeks||||ng/ml||Standard Deviation|Mean
1365394|NCT01620593|Primary|Metabolic Syndrome Waist Circumference|Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in waist circumference.|Change from 12 to 28 weeks||||centimeters||Full Range|Mean
1365395|NCT01620593|Primary|Metabolic Syndrome|Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in weight.|Change from 0 weeks to 28 weeks|Only subjects that completed the study were analyzed|||kilograms||Full Range|Mean
1365396|NCT01620489|Secondary|Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)|Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.|Week 0, week 26|Safety analysis set included all subjects receiving at least one dose of the trial product. A total of 8 subjects in the safety analysis set did not contribute to the analysis due to missing data.|||mL/min/1.73m˄2||Geometric Coefficient of Variation|Geometric Mean
1365397|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)|Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||kg/m^2||Standard Deviation|Mean
1365398|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles|SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 46 subjects in the FAS did not contribute to the analysis due to missing data.|||mmol/L||Standard Deviation|Mean
1365399|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||percentage of patients|||Number
1365400|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||percentage of patients|||Number
1365401|NCT01620489|Primary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)|Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects that received at least one dose of the study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||percentage (%)||Standard Deviation|Mean
1365402|NCT01620255|Secondary|Maximum Serum PF-00547659 Concentration Achieved||Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal|Participants who received active treatment (PF-00547659) were included in this analysis.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1365403|NCT01620255|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Screening through to end of treatment period, up to 12 weeks|All randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1365404|NCT01620255|Secondary|Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12|IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. A score of >=170 corresponds to clinical remission.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.|||percentage of participants||90% Confidence Interval|Number
1365405|NCT01620255|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12|IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.|Baseline (BL), Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point for that specific domain.|||units on a scale||Standard Deviation|Mean
1365406|NCT01620255|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
1365407|NCT01620255|Secondary|Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12|hsCRP was one of the PD biomarkers of the study.|Baseline; Weeks 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.|||percent change||90% Confidence Interval|Geometric Mean
1365408|NCT01620255|Secondary|Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12|Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.|Baseline, Weeks 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.|||percent change||90% Confidence Interval|Geometric Mean
1365409|NCT01620255|Secondary|Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of <0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at Week 12.|||percentage of participants|||Number
1365410|NCT01620255|Secondary|Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (<) 0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.|Baseline; Weeks (W) 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point for that endpoint.|||percentage of participants|||Number
1365411|NCT01620255|Secondary|Change From Baseline in Total Mayo Score at Week 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants in that specified category.|||units on a scale||Standard Deviation|Mean
1365412|NCT01620255|Secondary|Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12|"An absolute Partial Mayo Score of <=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of absolute Partial Mayo Score <=2, it was stated as change from baseline in Partial Mayo Score <=2."|Weeks 4, 8, and 12|As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented.||||||
1365413|NCT01620255|Secondary|Percentage of Participants With Mucosal Healing at Week 12|Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.|||percentage of participants||90% Confidence Interval|Number
1365414|NCT01620255|Secondary|Percentage of Participants With Clinical Response at Week 12|Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of participants evaluable for the specified category.|||percentage of participants||90% Confidence Interval|Number
1365415|NCT01620255|Primary|Percentage of Participants in Clinical Remission at Week 12|Clinical remission was defined as a Total Mayo Score of less than or equal (<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on a modified intent-to-treat (mITT) analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.|||percentage of participants||90% Confidence Interval|Number
1365416|NCT01620177|Secondary|THC Concentration Levels in Whole Blood|Measurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.|-0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis||||ng/ml||Full Range|Median
1366354|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 4|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4||||units on a scale||Standard Deviation|Mean
1365417|NCT01620177|Secondary|THC Concentration in Plasma Sample|Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.|-0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administration|We performed noncompartmental analyses with Phoenix WinNonLin® 6.3 for Windows (Pharsight) for maximum concentration (Cmax) of 11-OH-THC (LOQ 1 μg/L).|||ng/ml||Full Range|Median
1365418|NCT01620177|Primary|Driving Performance|Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.|Through entire drive, 0.5-1.3 hr post cannabis administration.|One subject who was an extreme outlier across driving performance measures was excluded. Due to the variability in THC and BrAC levels across subjects and conditions, a regression model was used which combined all of the data.|||cm|||Number
1365419|NCT01620138|Primary|Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma|Magnetic resonance imaging (MRI) of the sella and prolactin will be performed before (baseline) and after 6 months of treatment with cabergoline or pasireotide. Disease progression will be defined as tumor growth > 25%, stable disease as changes < 25% and significant tumor shrinkage as > 25% in tumor volume compared to baseline MRI (baseline to six months).|Baseline to six months||||cmˆ3||Full Range|Median
1365420|NCT01620086|Secondary|Depression Level Changes as Measured by the Hamilton Depression Inventory (HAMD).|HAM-D is a multiple choice questionnaire that clinicians administer to rate the severity of a subject's depression. There are 17 questions; each question has between 3-5 possible responses which increase in severity (range 0 to 52). The clinician chooses the correct response by interviewing the subject and by observing the symptoms. A score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.|||units on a scale||Standard Deviation|Mean
1365421|NCT01620086|Secondary|Overall Change in the Percent Habituation of the P50 Evoked Response Potential at 250 Inter Stimulus Interval (ISI) Between the Control and Active Treatments (1 and 10 Hz).|Percent habituation refers to change in the amplitude of the P50 evoked response potential following a 250 ms inter stimulus interval. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Three patients had missing data for the control site - baseline condition and the active 1 Hz treatment site -baseline conditions. One patient had missing data for the active 10 Hz treatment site - baseline.|||percent of change in wave amplitude||Standard Deviation|Mean
1365422|NCT01620086|Primary|Changes in Auditory Hallucinations Questionnaire (AHQ).|The Auditory Hallucinations Questionnaire (AHQ) will be used to determine the patient's perceptions of change in auditory hallucinations(s). Normal controls do not fill out this measure because they do not have auditory hallucinations. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. The range of scores is 0-70, higher scores mean more symptoms.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.|||units on a scale||Standard Deviation|Mean
1365423|NCT01620060|Secondary|Number of Participants With Serious Adverse Events and Non-serious Adverse Events|Serious adverse event and adverse events data will be listed and summarized as per MedDRA V15.0|11 Days||||participants|||Number
1365424|NCT01620060|Primary|Lurasidone Peak Serum Concentration (Cmax)|Cmax will be listed and summarized in tabular format|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours||||ng/mL||Standard Deviation|Mean
1365425|NCT01620060|Primary|Lurasidone Primary Pharmacokinetic Parameters|Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours|"Participants for PK analysis included all subjects who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK timepoint after start of dosing for at least 1 PK analyte.~For some PK parameters, some subjects didn't have PK data."|||ng.h/mL||Standard Deviation|Mean
1365426|NCT01620047|Secondary|Serum Fentanyl Levels|To identify a difference in serum fentanyl levels among the groups.|24 hours post-surgery|||||||
1365427|NCT01620047|Secondary|VAS Scores and Postoperative Supplemental Morphine Consumption|"Secondary Objective~To determine the amount of required supplemental analgesia during the postoperative period.~To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 – 10 centimeter line."|24 hours post-surgery|||||||
1365428|NCT01620047|Primary|Comparison of Postoperative Strength (Extension)|To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.|24 hours post-surgery|Per protocol|||Nm/kg||Full Range|Median
1365445|NCT01619787|Primary|Change in Energy Purchased as a Result of Subsidies|Change in total calories as a result of subsidies of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.|||Total Calories Purchased||Standard Error|Least Squares Mean
1365429|NCT01619982|Secondary|Count of Participants Experiencing Adverse Events Commonly Associated With Peri-operative Vancomycin Prophylaxis|"Will evaluate for vancomycin associated pre or intraoperative adverse events:~Hypotension requiring treatment~Rash, flushing or Red Man's syndrome~Other changes in vital signs (decrease in baseline 02 sat, increased heart or respiratory rate, elevated body temperature) felt to be associated with vancomycin administration~An event associated with vancomycin administration which results in delay in surgery"|Adverse events to vancomycin will be assessed on each patient in the study during the time the patient is in the operating room (0-<24 hours)|Only the Cefazolin 25 mg/kg Body Weight and Vancomycin groups were assessed, the Cefazolin 30mg/kg body weight did not receive vancomycin|||Participants|||Count of Participants
1365430|NCT01619982|Secondary|Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children on Cardiopulmonary Bypass (CPB)|Vancomycin pharmacokinetics measured as Elimination Clearance, Inter-tissue Clearance (Fast), Inter-tissue Clearance (Slow).|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm|||L/min||95% Confidence Interval|Median
1365431|NCT01619982|Secondary|Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children During the Peri-operative Period in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)|Vancomycin pharmacokinetics measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm|||L||95% Confidence Interval|Median
1365432|NCT01619982|Secondary|Cefazolin Pharmacokinetics|Measured as Elimination Clearance Inter-tissue Clearance (Fast) Inter-tissue Clearance(Slow)|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group|||L/min||95% Confidence Interval|Median
1365433|NCT01619982|Secondary|Cefazolin Pharmacokinetics|Cefazolin Pharmacokinetics was measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group|||L||95% Confidence Interval|Median
1365434|NCT01619982|Primary|Number of Patients Who Receive Preoperative Vancomycin and Cefazolin Who Develop a Surgical Site Infection Compared to Those Whose Received Only Cefazolin.|Number of patients who receive preoperative vancomycin and cefazolin who develop a surgical site infection (SSI) compared to those whose received only cefazolin. Surveillance was done with standard procedures and definitions.|Patients will be monitored for superficial SSIs for 30 days from the date of surgery. Patients will be monitored for 30 days for deep SSIs if no foreign material was implanted and for 1 year if foreign material is present.|Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients undergoing cardiopulmonary bypass|||participants|||Number
1365435|NCT01619878|Secondary|Time to Gametocyte Clearance (GCT)|Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||hours||Standard Deviation|Mean
1365436|NCT01619878|Secondary|Time to Fever Clearance (FCT)|Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||hours||Standard Deviation|Mean
1365437|NCT01619878|Secondary|Time to Parasite Clearance (PCT)|Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||hours||Standard Deviation|Mean
1365438|NCT01619878|Secondary|Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline|Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.|72 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||participants|||Number
1365439|NCT01619878|Secondary|Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline|Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.|48 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||participants|||Number
1365440|NCT01619878|Secondary|Percent Change of Parasite Count From Baseline at 24 Hours|Percent change of parasite count from baseline at 24 hours|baseline, 24 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||Percent Change||Standard Deviation|Mean
1365441|NCT01619878|Secondary|Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42|Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.|Day 3, 7, 14, 28 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||participants|||Number
1365442|NCT01619878|Secondary|Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|Day 14 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||Number of participants|||Number
1365443|NCT01619878|Primary|Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|28 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||number of participants|||Number
1365446|NCT01619787|Primary|Change in Energy Purchased as a Result of Taxes.|Change in total calories as a result of taxes of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.|||Total Calories Purchased||Standard Error|Least Squares Mean
1365447|NCT01619774|Secondary|Progression-Free Survival (PFS)|Duration of response defined for subjects with a confirmed complete response (CR) or partial response (PR), as time from the first documented evidence of a CR or PR until the first documented disease progression or death due to any cause. Progression free survival (PFS) estimated and summarized using the method of Kaplan and Meier.|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response therefore not included PFS analysis.|||weeks||95% Confidence Interval|Median
1365448|NCT01619774|Primary|Number of Participants by Response|Clinical responses evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks). Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study.|Evaluation every 8 weeks (2 cycles) up to 12 months||||participants|||Number
1365449|NCT01619774|Primary|Overall Response Rate (ORR)|"Overall response rate defined as percentage of subjects with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Clinical responses will be evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks).~Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study."|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response.|||Percentage of Participants|||Number
1365450|NCT01619579|Primary|Symptom Severity (SS) Score After 4 Weeks Treatment|"Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome).~The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale:~0 = no problem~slight or mild~moderate~severe: continuous, life-disturbing"|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.|||units on a scale||Full Range|Mean
1365451|NCT01619579|Primary|Tender Point Count (TPC) After 4 Weeks Treatment|"Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites.~Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points."|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.|||units on a scale||Full Range|Mean
1365452|NCT01619579|Primary|Widespread Pain Index (WPI) Score After 4 Weeks Treatment|Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.|||units on a scale||Full Range|Mean
1365453|NCT01619423|Primary|Number of Patients With Neuropathy Grade 2 or Higher (According to the Oxaliplatin Specific Sanofi Scale (OSSS) Criteria Related Paraesthesia/Dysaesthesia)|Percentage of patients, over cycle 1 to 8, with neuropathy grade 2 or higher (according to the Oxaliplatin Specific Sanofi Scale (OSSS) criteria related paraesthesiae/dysaesthesiae)|Every second week during cycle 1-8, for up to 16 weeks|Full analysis set|||Participants|||Count of Participants
1365454|NCT01619085|Primary|Incidence of Adverse Events (AE)|This is the measure for percentage of patients with adverse events observed during the trial. The incidence of AEs (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.|From first drug administration until treatment period, in total up to 56.3 months.|Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose.|||Percentage of patients (%)|||Number
1365455|NCT01619059|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values|||Percent of participants||95% Confidence Interval|Number
1365456|NCT01619059|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24|||mg/dL||Standard Error|Mean
1365473|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
1365457|NCT01619059|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24|||mg/dL||Standard Error|Mean
1365458|NCT01619059|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24|||Percent of glycosylated haemoglobin||Standard Error|Mean
1365459|NCT01618968|Primary|Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration (Cmax) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng/mL/mg||Standard Deviation|Mean
1365460|NCT01618968|Primary|Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng*hr/mL/mg||Standard Deviation|Mean
1365461|NCT01618968|Primary|Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng*hr/mL/mg||Standard Deviation|Mean
1365462|NCT01618955|Secondary|Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.~Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection."|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For continuous data, summary statistics (N, mean, standard deviation, median, minimum, and maximum) were provided.|||mm||Standard Deviation|Mean
1365463|NCT01618955|Secondary|Safety of Vibex MTX Device|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device~Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following:~Erythema - 0 = None~Erythema - 1 = Very slight, barely perceptible~Erythema - 2 = Obvious, but well defined~Erythema - 3 = Moderate to severe~Erythema - 4 = Severe"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, counts and percentages are presented.|||Percentage of Participants|||Number
1365464|NCT01618955|Secondary|Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device~Ease of use Questionnaire was completed by patients immediately after self-injection~Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.|||Percentage of Participants|||Number
1365465|NCT01618955|Primary|Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.~The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient’s performance of essential self-injection steps, including the following:~SC self-injection was administered by the patient~SC self-injection was intentional~self-injection was administered in an appropriate location on the abdomen~patient removed cap marked “1~patient removed cap marked “2~patient held device at injection site for 3 seconds~patient confirmed that the window was obstructed"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.|||Percentage of Participants|||Number
1365466|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.01cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
1365467|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
1365468|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.01 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
1365469|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
1365470|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
1365471|NCT01618942|Secondary|Measuring Values of Skinfold Thickness||10 minutes after the procedure||||millimeters||Standard Deviation|Mean
1365472|NCT01618942|Secondary|Time of Each Test Procedure||10 minutes after the procedure||||seconds||Standard Deviation|Mean
1365474|NCT01618864|Secondary|Reduction in Rosacea by the Study Investigator Using a Validated Scale|Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.|4, 8 weeks|Not all subjects had rosacea. 11 subjects evaluated at baseline and 4 weeks; 9 subjects evaluated at 8 weeks, since 2 subjects lost to follow-up.|||percentage of participants|||Number
1365475|NCT01618864|Secondary|Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale|Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.|4, 8 weeks||||percentage of participants|||Number
1365476|NCT01618864|Primary|Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)|Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.|4, 8 weeks||||percentage of participants|||Number
1365477|NCT01618838|Secondary|Progression-free Survival|Progression-free survival will be defined as the time in months from study entry until progression or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date. Data table reports the number of participants who were alive without progression at the end of the study.|Planned for 7 years, collected up to 23 months||||Participants|||Count of Participants
1365478|NCT01618838|Secondary|Proportion of Patients With Rectal Bleeding.||Planned for 7 years, collected up to 23 months|No patients had outcome before the trial was terminated.|||Participants|||Count of Participants
1365479|NCT01618838|Primary|Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).|"Telangiectasia is the primary outcome since it is a measure of tissue fibrosis (primary source of proctitis) and is a well-defined and measurable outcome.~No patients had outcome before the trial was terminated."|Planned for 7 years, collected up to 23 months||||Participants|||Count of Participants
1365480|NCT01618708|Secondary|Percentage of WOMAC A1 Responder Over 26 Weeks|WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.|From Baseline to Week 26|ITT population.|||Percentage of participants|||Number
1365481|NCT01618708|Secondary|Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks|PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.|From baseline to Week 26|ITT population.|||units on a scale||Standard Error|Least Squares Mean
1365482|NCT01618708|Secondary|Change From Baseline in WOMAC A Score Over 26 Weeks|WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From Baseline to Week 26|ITT population.|||units on a scale||Standard Error|Least Squares Mean
1365483|NCT01618708|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks|WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From baseline to Week 26|ITT population.|||units on a scale||Standard Error|Least Squares Mean
1365484|NCT01618669|Secondary|Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson|"An adverse event is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes:~Results in death,~Is life threatening,~Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions,~Results in congenital anomaly, or birth defect,~Requires inpatient hospitalization or leads to prolongation of hospitalization~Other medically important events.~Relationship to study drug was assessed by the investigator."|Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)|Safety Analysis Set.|||participants|||Number
1365485|NCT01618669|Secondary|Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity|The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported.|Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)|Full Analysis Set|||percentage of segments|||Number
1365486|NCT01618669|Secondary|Percentage of Scans With Subdiaphragmatic Interference|Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set|||percentage of stress MPI scans|||Number
1365487|NCT01618669|Secondary|Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans|Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference).|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full analysis set participants who have planar images available for each scan|||ratio||Standard Deviation|Mean
1365488|NCT01618669|Secondary|Overall Assessment of Image Quality|The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan.|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||participants|||Number
1365564|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on-or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1365489|NCT01618669|Secondary|Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan|Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category.|Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)|Full Analysis Set|||participants|||Number
1365490|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/ uptake~2: moderately reduced contrast/uptake~3: severely reduced contrast/uptake~4: absent contrast/uptake.~SSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS – SRS).~The mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||participants|||Number
1365491|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||proportion of participants|||Number
1365492|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI.|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||proportion of participants||95% Confidence Interval|Number
1365493|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set|||proportion of participants||95% Confidence Interval|Number
1365494|NCT01618669|Secondary|Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events|"A clinically significant cardiac event is defined as:~Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration:~ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter),~ST-T depression (> 2 mm),~ST-T elevation (≥1 mm),~Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block)~sinus arrest > 3 seconds in duration~Or~a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction~Or~a TEAE preferred term of angina unstable within 24 hours of regadenoson administration."|Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson|Safety analysis set (all randomized participants who received at least 1 dose of regadenoson study drug)|||percentage of participants|||Number
1365495|NCT01618669|Primary|Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans|"SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect.~The number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia.~Each reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits.~Majority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant."|Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)|Full Analysis Set|||proportion of participants||95% Confidence Interval|Number
1365520|NCT01618214|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomisation measurements were available. Six subjects did not contribute to FAS due to lack of post-randomisation measurements.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1365496|NCT01618422|Primary|Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group.|"Cure (Completed for 8 months or more of therapy and culture converted in the last month of treatment, and on at least one previous occasion; for multidrug resistant TB (MDR-TB) switched to definitive second line therapy per protocol in the DOTS-plus group, sustained culture conversion for at least 6 months after initiation of second line therapy and no evidence of culture reversion up to the scheduled follow-up point); Treatment failure: not culture converted at 5 months or later; Defaulted: having interrupted treatment for 2 consecutive months or more; Transfer out: having been transferred to another recording and reporting unit and for whom the treatment outcome is not known; Death: a patient who died for any reason during the course of treatment Diagnosis revised: diagnosis revised to non-tuberculous mycobacterial infection or colonisation.~Withdrawal: physician-initiated withdrawal for adverse effects, protocol violation or patient’s decision to withdraw."|18-month||||participants|||Number
1365497|NCT01618344|Primary|Feasibility and Acceptability of Using a Smart-phone Medication Reminder Application to Promote Adherence to Oral Medications by AYA With Cancer.|Feasibility was assessed through participants' application usage and responses to self-reported questions about their use of the application. Acceptability was assessed through participants' perceived ease of use and perceived usefulness of the application.|ongoing study weeks 5-12||||Participants|||Count of Participants
1365498|NCT01618266|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 24|All enrolled patients|||Percentage of Patients|||Number
1365499|NCT01618266|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 6, Month 4, Month 12, Month 18, Month 24|All enrolled patients|||Letters||Standard Deviation|Mean
1365500|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.|Baseline, Month 6|All enrolled patients receiving Ozurdex® and then other RVO treatments|||Letters||Standard Deviation|Mean
1365501|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.|Baseline, Month 6|All enrolled patients only treated with Ozurdex|||Letters||Standard Deviation|Mean
1365502|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset ≥3 months|||Letters||Standard Deviation|Mean
1365503|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset <3 months|||Letters||Standard Deviation|Mean
1365504|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients previously naïve to Ozurdex® treatment|||Letters||Standard Deviation|Mean
1365521|NCT01618162|Secondary|Number of Adverse Events (AEs)|An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.|After 26 weeks of treatment|Safety analysis set.|||event rate per 100 PYE|||Number
1365505|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.|Baseline, Month 6|All enrolled patients previously treated with Ozurdex®|||Letters||Standard Deviation|Mean
1365506|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients who were treatment naïve|||Letters||Standard Deviation|Mean
1365507|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.|Baseline, Month 6|All enrolled patients with CRVO|||Letters||Standard Deviation|Mean
1365508|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.|Baseline, Month 6|All enrolled patients with BRVO|||Letters||Standard Deviation|Mean
1365509|NCT01618266|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Month 6|All enrolled patients|||Letters||Standard Deviation|Mean
1365510|NCT01618240|Secondary|Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration||Within 3 month follow-up||||participants|||Number
1365511|NCT01618240|Primary|Muscle Strength|We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.|Within 24 hours of fiberoptic endoscopic evaluation of swallow||||participants|||Number
1365512|NCT01618227|Secondary|Number of Additional Surgeries|The number of additional surgeries will be recorded and compared between groups.|6 months||||Number of Additional Surgeries|||Number
1365513|NCT01618227|Secondary|Number of Physical/Occupational Therapy Visits|Number of physical/occupational therapy visits will be collected from enrollment.|6 months||||visits||Standard Deviation|Mean
1365514|NCT01618227|Secondary|Wrist Range of Motion|Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.|6 months|Two subjects had the same range of motion at 6 months, therefore SD is 0.|||degrees||Standard Deviation|Mean
1365515|NCT01618227|Primary|Wrist Range of Motion|Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.|2 months||||degrees||Standard Deviation|Mean
1365516|NCT01618214|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.|Week 0 to week 20 (inclusive).|Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.|||events per patient per year|||Number
1365517|NCT01618214|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose)||Week 0, week 20|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. Seven subjects did not contribute to FAS due to lack of post-randomization measurements.|||mmol/L||Standard Deviation|Mean
1365518|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.|||percentage (%) of subjects|||Number
1365519|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.|||percentage (%) of subjects|||Number
1365540|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for AUClast|To evaluate the PK of LCL161 when given in combination with paclitaxel|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.|||ng*hr/mL||Full Range|Median
1365522|NCT01618162|Secondary|Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes|"An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.~Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.~Minor hypoglycaemic episodes were defined as:~An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.~Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).~Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE)."|After 26 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of the trial product.|||event rate per 100 PYE|||Number
1365523|NCT01618162|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight at week 26.|Week 0, week 26|Full analysis set.|||kilogram||Standard Deviation|Mean
1365524|NCT01618162|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at week 26.|Week 0, week 26|Full analysis set. Number of subjects analyzed=subjects with data available for FPG.|||mmol/L||Standard Deviation|Mean
1365525|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Percentage of subjects having HbA1c below 6.5% at week 26|Week 26|Full analysis set.|||percentage of subjects|||Number
1365526|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)|Percentage of subjects having HbA1c below 7% at week 26.|Week 26|Full analysis set.|||percentage of subjects|||Number
1365527|NCT01618162|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change in HbA1c from baseline to 26 weeks.|Week 0, Week 26|Full analysis set.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1365528|NCT01618019|Secondary|CTX Concentration|serum C-terminal telopeptide of type 1 collagen concentration as nmol/L|16 week|Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week|||nmol/L||Standard Error|Mean
1365529|NCT01618019|Secondary|BSAP Concentration|serum bone specific alkaline phosphatase concentration as U/L|16 week|Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week|||U/L||Standard Deviation|Mean
1365530|NCT01618019|Secondary|Osteocalcin Concentration|serum Osteocalcin concentration as nmol/L|16 week|Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week|||nmol/L||Standard Deviation|Mean
1365531|NCT01618019|Secondary|Pain Scale|Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week.|||units on a scale||Standard Deviation|Mean
1365532|NCT01618019|Secondary|Patient’s Global Assessment|Patient’s global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Patient’s global assessment at 16 week.|||units on a scale||Standard Deviation|Mean
1365533|NCT01618019|Secondary|Physician’s Global Assessment|"Physician’s global assessment is ranged from 0 to 10 by the assessing physician.~(0= no pain; 10= very severe pain)"|16 week|Per-protocol analysis (except for drop out patients) Measurement of Physician’s global assessment at 16 weeks.|||units on a scale||Standard Deviation|Mean
1365534|NCT01618019|Secondary|Duration of Morning Stiffness|Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.|16 week|Per-protocol analysis (except for drop out patients) Measurement of Morning stiffness assessment at 16 weeks, except for 16 in N-3 PUFA and 16 in placebo|||minutes||Standard Deviation|Mean
1365535|NCT01618019|Primary|Dose of NSAID|Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day|16 week|Per-protocol analysis (except for drop out patients) Measurement of NSAID requirements at 16 weeks, except for 10 in N-3 PUFA and 6 in placebo.|||mg||Standard Deviation|Mean
1365536|NCT01617681|Secondary|CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6|UACR response is defined as percentage change from baseline in UACR≤ 25%. UACR [mg/mmol] = urine albumin [mg/L] / urine creatinine [mmol/L] UACR was collected for CKD patients only. The UACR value at a given visit for a patient was to be derived by the median of the three lab values collected for that visit Week 6.|Week 6 weeks|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent - CKD patients only The number of patients with an UACR at baseline and week 6 endpoint (included in the analysis).|||participants|||Number
1365537|NCT01617681|Secondary|Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP|Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Week 6|Week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent|||participants|||Number
1365538|NCT01617681|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6|Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Baseline and Week 6 endpoint in Period 1 Double Blind Phase|Baseline, Week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent|||mmHg||Standard Error|Least Squares Mean
1365539|NCT01617681|Primary|Change From Baseline in Mean Systolic Blood Pressure (MSBP) at Week 6 Endpoint|Patient’s blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase|Baseline, week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent|||mmHg||Standard Error|Least Squares Mean
1376860|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout study period (approximately 17 months)||||Participants|||Number
1365541|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Tmax|To evaluate the PK of LCL161 when given in combination with paclitaxel. The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.|||h||Full Range|Median
1365542|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Cmax|To evaluate the PK of LCL161 when given in combination with paclitaxel.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.|||ng/mL||Full Range|Median
1365543|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS2|To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined. Cycle = 28 days; each patient had either C1D2 or C1D9|Baseline, Post-baeline at Cycle 1, Day 2 or Cycle 1, Day 9|The Efficacy Analysis Set 2 (EAS2) was the same as EAS1 except that the threshold for classifying a patient into the positive gene group was 0.7716. All the EAS2 set participants were considered for the analysis (N). Only participants (n) who had baseline and post baseline values for the given time point were analyzed for that time point.|||% of positive tumor cells||Standard Deviation|Mean
1365544|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS1|"To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined.~Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661 (positive: score ≥ 0.6661; negative: score <0.6661); cycle = 28 days; each patient had either C1D2 or C1D9"|Baseline, Post-baeline at Cycle 1, Day 2 (C1D2) or Cycle 1, Day 9 (C1D9)|Efficacy Analysis Set 1 (EAS1) is patients (pts) who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with valid gene expression signature score. All pts were considered for analysis (N). Only pts (n) with baseline & post baseline values for the given time point were analyzed for that time point.|||% of positive tumor cells||Standard Deviation|Mean
1365545|NCT01617668|Secondary|Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. Rates of breast conserving surgery and mastectomy also contributed to the overall assessment of disease response and were summarized by treatment arm within each gene expression signature status. For this analysis, patients with multicentric breast cancer were excluded, as all patients in this group were expected to be treated with mastectomy.|16 weeks|EAS1 - patients receiving at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature (GES) score. GES status is derived based on continuous GES score using cut-off 0.6661(pos: score ≥ 0.6661; neg: score <0.6661). Patients with multicentric breast cancer were excluded.|||Percentage of participants|||Number
1365546|NCT01617668|Secondary|pCR Rate in Breast, Regional Nodes and Axilla|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. The pCR in breast, regional nodes, and axilla were determined based on the America Joint Committee on Cancer Staging [AJCC] stages T1c, T2, N0-N2, M0) were (AJCC) pathologic staging recorded on the eCRF: a patient was considered to be a responder in breast, regional nodes, and axilla if the pathological complete response was reported for breast and if the regional lymph nodes staging was pN0 (including i-, mol-, mol+).The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Percentage of participants||95% Confidence Interval|Median
1365547|NCT01617668|Secondary|pCR Rate in Breast After 12 Weeks of Therapy With Single Agent LCL161 and LCL161 + Paclitaxel, Regardless of Gene Signature Status|To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer regardless of tumor gene expression signature status. This comparison is between the 2 study treatments, regardless of gene signature status. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Percentage of participants||95% Confidence Interval|Median
1365548|NCT01617668|Secondary|Posterior Distribution of Difference in pCR Rates After Treatment With Paclitaxel Only Between Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with paclitaxel only. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Difference in percentage of participants||95% Confidence Interval|Median
1365563|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365549|NCT01617668|Secondary|Posterior Distribution of Difference of pCR Rates After Treatment With LCL161 + Paclitaxel Between Patients With Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with LCL161 and paclitaxel. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Difference in percentage of participants||95% Confidence Interval|Median
1365550|NCT01617668|Primary|Difference in pCR Rates Between Treatment Arms|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on the posterior distribution of the difference in pCR rates between the experimental and control arms of the study, within each gene expression signature group.The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|FAS are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or 1 full or partial dose of paclitaxel alone. These values are medians of posterior distribution of difference of pCR rate between treatment arms based on a Bayesian model. 95% Confidence interval is actually 95% credible interval.|||Difference in percentage of participants||95% Confidence Interval|Median
1365551|NCT01617668|Primary|Number of Participants With Pathological Complete Response (pCR) in Breast After 12 Weeks of Therapy|To assess the number of patients who experienced a pathological response in breast.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.|||Participants|||Number
1365552|NCT01617668|Primary|Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.|||Percentage of Participants||95% Confidence Interval|Median
1365553|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 i.e. up to 21 days after last injection.|From Baseline to Week 78|mITT population.|||percent change||Standard Error|Least Squares Mean
1365554|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.|||percent change||Standard Error|Least Squares Mean
1365555|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1365556|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
1365557|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|Up to Week 52|ITT population.|||percentage of participants|||Number
1365558|NCT01617655|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
1365559|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365560|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1365561|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365562|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post­baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on-or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
1365565|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1365566|NCT01617655|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
1365567|NCT01617655|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
1365568|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1365569|NCT01617655|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1365570|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1365571|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1365572|NCT01617655|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1365573|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
1365574|NCT01617655|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1365575|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
1365576|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1365577|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1365578|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1365626|NCT01617083|Secondary|Clinical Global Impressions-Severity OCD|The CGI-S scale is a 7-point clinician rating of severity of psychopathology. Severity ratings range from 1 (no illness) to 7 (extremely severe). This instrument has been successfully used in treatment studies (Cook, et al., 2001; Storch, et al., 2007).|Before and after 4 week randomization||||units on a scale||Standard Error|Mean
1365579|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1365580|NCT01617655|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post­baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off- treatment.|||percent change||Standard Error|Least Squares Mean
1365581|NCT01617629|Other Pre-specified|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|2 years|Due to the few patients, Overall Survival could not be calculated.||||||
1365582|NCT01617629|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|First dose of study vaccine to 30 days past last dose (Approximately 1 Year)|Safety Population included all participants who enrolled in the study.|||participants|||Number
1365583|NCT01617603|Secondary|Oxidative Stress After 12 Weeks of Product Intake|Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF) at the 84th day of product intake|84th day of product intake|||||||
1365584|NCT01617603|Secondary|Cholesterol Profile After 12 Weeks of Product Intake|Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake|84th day of product intake|||||||
1365585|NCT01617603|Secondary|Endothelial Function After 12 Weeks of Product Intake|Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)|84th day of product intake|||||||
1365586|NCT01617603|Primary|Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake|HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index > 2.4|84th day of product intake||||HOMA index||Inter-Quartile Range|Mean
1365587|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:~mean ADAScog: a decrease in total score units = improvement, min=0 max= mean PAL (memory): an increase in score = improvement, mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and final visit (14 wks)||||units on a scale||Standard Error|Mean
1365588|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:~mean ADAScog: a decrease in total score units = improvement, min=0 max=31 mean PAL (memory): an increase in score = improvement, min= 0 max=12 mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and 2wk and 4 wk after Rx;||||units on a scale||Standard Error|Mean
1365589|NCT01617460|Primary|Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score|The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.|Baseline, the final administration||||units on a scale||Standard Deviation|Mean
1365590|NCT01617447|Primary|Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score|The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.|baseline, 8 weeks after dosing||||units on a scale||Standard Error|Mean
1365591|NCT01617434|Secondary|Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period|Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Events/100 years of patient exposure|||Number
1365592|NCT01617434|Secondary|Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period|A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Events/100 years of patient exposure|||Number
1365593|NCT01617434|Secondary|Number of Adverse Events (AEs) During The Randomised Treatment Period|An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial product.|||Events/1000 years of patient exposure|||Number
1365594|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)|Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||percentage of subjects|||Number
1365595|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)|Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||percentage of subjects|||Number
1365596|NCT01617434|Secondary|Change in Body Weight From Baseline to Week 26|The estimated mean change in body weight after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 216 subjects in the placebo arm contributed to the statistical analysis.|||kg||Standard Deviation|Mean
1365597|NCT01617434|Secondary|Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26|The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 191 subjects in the liraglutide arm and 196 subjects in the placebo arm contributed to the statistical analysis.|||mmol/L||Standard Deviation|Mean
1365598|NCT01617434|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 213 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||mmol/L||Standard Deviation|Mean
1365599|NCT01617434|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26|The estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1365600|NCT01617369|Primary|Change in Whole Lung Mucociliary Clearance|"The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.~Absolute change in MCC-Ave90 from baseline reported for each arm"|30 minutes and 4 hours after inhalation|Per Protocol|||% Clearance||Standard Deviation|Mean
1365601|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365602|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365603|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365680|NCT01615939|Secondary|Pain Control|Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable|72 hrs||||units on a scale||Inter-Quartile Range|Median
1377621|NCT01479478|Secondary|Count of Neonates With Meningitis||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1365604|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365605|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365606|NCT01617187|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365607|NCT01617187|Secondary|Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365608|NCT01617187|Secondary|Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365609|NCT01617187|Secondary|Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||percentage of participants|||Number
1365610|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35|CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365611|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35|A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||percentage of participants|||Number
1365681|NCT01615939|Secondary|Participant Satisfaction With Anesthesia|Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied|24 hours||||units on a scale||Inter-Quartile Range|Median
1365612|NCT01617187|Secondary|Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365613|NCT01617187|Secondary|Change From Baseline in Body Weight at Day 42|Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.|Baseline and Day 42|All randomized participants who received ≥1 dose of study drug|||kg||Standard Error|Least Squares Mean
1365614|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42|Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||percentage of participants|||Number
1365615|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Day 42|Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365616|NCT01617187|Primary|Change From Baseline in PANSS Total Score at Day 42|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
1365617|NCT01617148|Secondary|Percentage of Subjects Who Were 20/200 or Worse at Month 12.|Percentage of subjects who had visual acuity of 20/200 or worse at month 12.|month 12||||Participants|||Count of Participants
1365618|NCT01617148|Secondary|Percentage of Subjects Who Were 20/40 or Better at Month 12.|Percentage of subjects who had vision acuity of 20/40 or better at month 12.|month 12||||Participants|||Count of Participants
1365619|NCT01617148|Secondary|Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months|The percentage of patients who lost greater than 15 letters of vision from baseline at 12 months.|baseline and 12 months||||Participants|||Count of Participants
1365620|NCT01617148|Secondary|Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months.|The percentage of patients who gained greater than 15 letters of vision from baseline to 12 months.|baseline and 12 months||||Participants|||Count of Participants
1365621|NCT01617148|Secondary|Change in Cube Average Thickness From Baseline at 12 Months|Mean absolute change in cube average thickness as measured by SDOCT from baseline at 12 months.|baseline and 12 months||||µm||Standard Deviation|Mean
1365622|NCT01617148|Secondary|Change in Macular Volume From Baseline at 12 Months.|Mean absolute change from baseline in macular volume at 12 months.|baseline and 12 months||||mm3||Standard Deviation|Mean
1365623|NCT01617148|Secondary|Change in Best-corrected Visual Acuity From Baseline at 12 Months|The mean absolute change from baseline in best-corrected visual acuity score at 12 months as measured by Eletronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) protocol. There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters.|Baseline and 12 months||||E-ETDRS letters||Standard Deviation|Mean
1365624|NCT01617148|Primary|Change in Central Subfield Thickness From Baseline at 12 Months|The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT|baseline and 12 months||||µm||Standard Deviation|Mean
1365625|NCT01617083|Secondary|Screen for Childhood Anxiety-Related Emotional Disorders (SCARED)|The Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) is a 41-item parent and participant-completed tool used to measure symptoms of anxiety, including the most common symptoms of panic/somatic, generalized anxiety, separation anxiety, social phobia, and school phobia. Scores range from 0-82, with higher scores indicating more severe symptoms.The child and parent versions of the SCARED have moderate parent–child agreement and good internal consistency, test–retest reliability, and discriminant validity; it is also sensitive to treatment response (Birmaher et al. 1999). The target population for this rating is 8–18 years of age (Birmaher et al. 1997). The parent and child version of the SCARED were administered before and after week 4 randomization. This measure is not validated for use in 4–7 year olds.|Before and after 4 week randomization||||units on a scale||Standard Error|Mean
1365682|NCT01615939|Primary|Temporary Neurologic Symptoms Between Groups|Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion|1 month||||percentage of total participants|||Number
1365627|NCT01617083|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CYBOCS is a clinician rated, semi-structured interview for rating the severity of OCD (Scahill, et al., 1997). Total scores range from 0 to 50, with higher scores representing greater severity. The total score is comprised of two subscores, obsessions and compulsions, each with a range of 0-25.|Before and after 4 week randomization||||units on a scale||Standard Error|Mean
1365628|NCT01617070|Primary|Urine Dopamine at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.|||ug/gCreatinine||Standard Deviation|Mean
1365629|NCT01617070|Primary|Urine 6-sulfatoxymelatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.|||ng/mg Creatinine||Standard Deviation|Mean
1365630|NCT01617070|Primary|Serum Melatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.|||pg/ml||Standard Deviation|Mean
1365631|NCT01617005|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline up to Week 24|As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable.||||||
1365632|NCT01617005|Secondary|Number of Participants Who Discontinued Treatment Due to Lack of Efficacy||Baseline up to Week 24|All participants enrolled in the study.|||participants|||Number
1365633|NCT01617005|Secondary|Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria|EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.|Baseline, Week 24|All participants enrolled in the study.|||participants|||Number
1365634|NCT01617005|Primary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.|Baseline up to Week 24|All participants enrolled in the study.|||participants|||Number
1365635|NCT01616953|Secondary|Implant Stabilization|The ability of the dental implant fixtures to be loaded and remain stable for six months following implant loading (at 4 months) will be evaluated.|10 months||||participants|||Number
1365636|NCT01616953|Primary|Bone Regeneration|The primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.|4 months||||implant sites||Standard Deviation|Mean
1365637|NCT01616771|Secondary|The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL|"Glottis view was scored using C&L grade by GVL selected by weight and smaller sized GVL, and compared each other.~Score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1day of surgery|Four of 23 patients could not be evaluated by smaller sized GVL because there was no smaller blade than their GVL selected by weight.|||units on a scale||95% Confidence Interval|Median
1365638|NCT01616771|Primary|The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.|"Glottis view was scored using C&L grade by Macintosh laryngoscope and GVL selected by weight, and compared each other.~We used modified C&L grade: grade 1, all or most of the glottic aperture was visible; grade 2a, posterior cords and cartilage visible; grade 2b, only posterior cartilage visible; grade 3a, epiglottis visible and can be lifted; grade 3b, epiglottis adherent to the posterior pharynx; and grade 4, the epiglottis could not be visualized.~For the statistical analysis, the modified C&L grade was converted to an ordinal scale; grade 1 to 1, grade 2a to 2, grade 2b to 3, grade 3a to 4, grade 3b to 5, and grade 4 to 6. Therefore, score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1 day of surgery||||units on a scale||95% Confidence Interval|Median
1365639|NCT01616576|Primary|Device-related Adverse Events|Device-related adverse events will be assessed to determine whether they impact current device safety performance.|2 weeks||||Events|||Number
1365640|NCT01616576|Primary|Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.|Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.|2 weeks||||Percent Correct||Standard Deviation|Mean
1365641|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
1365683|NCT01615822|Secondary|MQ Cmax|Peak Plasma Concentration (Cmax) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1365642|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
1365643|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
1365644|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase. But no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available||||||
1365645|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. OPA-19A results were not available at the time of writing this summary. The summary will be updated when they become available.|At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine||2017-12-31|12/2017||||
1365646|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.. OPA-19A results were not available at the time of writing this summary. The summary will be updated when they become available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine||2017-12-31|12/2017||||
1365647|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study|Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Booster ELISA 6A results were not available at the time of writing this summary. The summary will be updated when they become available.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine||2017-12-31|12/2017||||
1365648|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Day 0 to Month 11|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.|||Subject|||Number
1365649|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.|||Subject|||Number
1365650|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.|||Subject|||Number
1365684|NCT01615822|Secondary|MQ AUC0-t|Area under the plasma concentration versus time curve (AUC) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1365685|NCT01615822|Secondary|OZ439 Cmax|Peak Plasma Concentration (Cmax) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1365651|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.|||Subject|||Number
1365652|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Subject|||Number
1365653|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Subjects|||Number
1365654|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Subjects|||Number
1365655|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Subjects|||Number
1365656|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1365657|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1365686|NCT01615822|Primary|OZ439 AUC0-t|Area under the plasma concentration versus time curve (AUC) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366355|NCT01607853|Secondary|Change From Baseline in Erythema at Day 22|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22||||units on a scale||Standard Deviation|Mean
1365658|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||Titers||95% Confidence Interval|Geometric Mean
1365659|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Titers||95% Confidence Interval|Geometric Mean
1365660|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||µg/mL||95% Confidence Interval|Geometric Mean
1365661|NCT01616459|Primary|Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes|"N = number of subjects with post primary vaccination results available.~% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.~Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A).~Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
1365662|NCT01616459|Primary|Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes|"N = number of subjects with post primary vaccination results available.~% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.~Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).~Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
1365663|NCT01616459|Primary|Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype|"N = number of subjects with post primary vaccination results available.~% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.~Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A).~Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
1365664|NCT01616459|Primary|Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes|"N = number of subjects with post primary vaccination results available.~% = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL.~Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).~Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA)."|1 month post-dose 3 (primary phase)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
1367912|NCT01591616|Secondary|ECGs (Ventricular Heart Rate)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||Beats per minute||Standard Deviation|Mean
1365665|NCT01616459|Primary|Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||µg/mL||95% Confidence Interval|Geometric Mean
1365666|NCT01616173|Secondary|Pain Scores|Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).|2 weeks||||units on a scale||Inter-Quartile Range|Median
1365667|NCT01616173|Secondary|Opioid Consumption|Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.|2 weeks||||mg/day||Inter-Quartile Range|Median
1365668|NCT01616173|Primary|Quality of Recovery|QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.|2 weeks||||units on a scale||Inter-Quartile Range|Median
1365669|NCT01616160|Primary|Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores|To assess steroid sensitivity in subjects comparing nasal endoscopy polyp score before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Nasal endoscopic polyp score measured on 0 to 4 scale ( 0 = no nasal polyp; 1 = polyp in the middle meatus, not below the inferior border of the middle turbinate (MT); 2 = polyp below the inferior border of the MT but not touching the inferior turbinate (IT); 3 = polyp below the inferior border of the MT and touching the IT; 4 = polyp to or below the lower border of the IT). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate that patients had a reduction in nasal polyp size at the end of the study.|Change between pre- and post-treatment symptom score after 4 weeks of treatment|Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.|||units on a scale||Standard Deviation|Mean
1365670|NCT01616160|Primary|Change in Steroid Sensitivity in Vivo Symptom Scores - Trouble With Sense of Smell|To assess steroid sensitivity in subjects comparing Trouble with sense of smell symptom scores before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Trouble with sense of smell measured on 0 to 4 scale ( 0 = no trouble with smell; 4 = severe trouble with smell). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate patients had less trouble with sense of smell at the end of the study.|Change between pre- and post-treatment symptom score after 4 weeks of treatment||||scores on a scale||Standard Deviation|Mean
1365671|NCT01616056|Secondary|Change in Optical Coherence Tomography|Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.|2 weeks|Optical coherence tomography results were not analyzed because of incomplete data collection.||||||
1365672|NCT01616056|Secondary|Change in Comprehensive Ophthalmologic Evaluations|LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.|2 weeks|Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection.|||logMAR||Standard Deviation|Mean
1365673|NCT01616056|Secondary|Number of Patients Who Experienced Serious Adverse Events|Safety of Bandage Contact Lenses at 1 month|1 month||||Participants|||Count of Participants
1365674|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale|The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.|3 months||||Participants|||Count of Participants
1365675|NCT01616056|Primary|Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale|The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.|3 months||||units on a scale||Standard Deviation|Mean
1365676|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI|OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.|3 months||||Participants|||Count of Participants
1365677|NCT01616056|Primary|Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index|OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.|3 months||||units on a scale||Standard Deviation|Mean
1365678|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale|8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).|3 months||||Participants|||Count of Participants
1365679|NCT01616056|Primary|Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale|Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx_eye=mean(sx6,sx7,sx8)*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.|3 months||||units on a scale||Standard Deviation|Mean
1365687|NCT01615809|Secondary|Invasive Pulmonary Aspergillosis -Related Mortality During Primary Prophylaxis With Abelcet®.|Percentage of deaths related to Invasive Pulmonary Aspergillosis during the prophylactic treatment period with Abelcet® in paediatric patients with Acute Leukaemia undergoing intensive chemotherapy.|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks||||percentage of deaths||95% Confidence Interval|Number
1365688|NCT01615809|Secondary|Efficacy of Primary Prophylaxis With Nebulized Abelcet® on the Incidence of Invasive Pulmonary Aspergillosis|The incidence of invasive pulmonary aspergillosis during the Abelcet® prophylactic treatment period was assessed by the relation between the number of patients with invasive pulmonary aspergillosis and the number of paediatric patients on prophylaxis with Acute Leukaemia (AL) undergoing intensive chemotherapy.|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks|At baseline, none of the 32 pediatric patients with acute leukemia included in the clinical trial had API. During the trial period there were 3 patients who developed API|||participants|||Number
1365689|NCT01615809|Primary|Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability|is assessed by the proportion of patients who discontinue prophylactic treatment with Abelcet® due to an adverse event that is related or not to the study drug or for intolerability to it. The last week of treatment will have a different calendar for each participant, depending on the number of cicles needed by each patient (it has been anticipated up to 5 cicles of 2-6 weeks each).|at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks|pediatric patients|||participants|||Number
1365690|NCT01615731|Secondary|Adverse Events|uterine perforation, uterine injury, etc.|Intraoperatively and 2 weeks post operatively||||participants|||Number
1365691|NCT01615731|Secondary|Overall Patient Experience|Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.|Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge||||units on a scale||Inter-Quartile Range|Median
1365692|NCT01615731|Secondary|Pain Perceived by Patient|Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.|Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)||||units on a scale||Inter-Quartile Range|Median
1365693|NCT01615731|Secondary|Ease of Procedure by Blinded Surgeon|Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.|Measured Immediately after procedure||||units on a scale||Inter-Quartile Range|Median
1365694|NCT01615731|Secondary|Adverse Events (EBL)|One adverse event: Estimated Blood Loss|Intraoperatively||||mL||Standard Deviation|Mean
1365695|NCT01615731|Secondary|Maximum Cervical Dilation|Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.|Measured intra-operatively|"Data missing for one subject in Mifepristone plus one set of dilators arm."|||participants|||Number
1365696|NCT01615731|Primary|Total Procedure Time||Measured at clinic visits and on OR day, over a 3 day period|"Data missing for two subjects in Mifepristone plus one set of dilators arm."|||hours||Standard Deviation|Mean
1365697|NCT01615731|Primary|Procedure Time|Measured as time from speculum insertion to removal|Intraoperative Time||||minutes||Standard Deviation|Mean
1365698|NCT01615484|Secondary|Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival|Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.|12 Months|Excludes those who were deceased at Month 12|||Participants|||Count of Participants
1365699|NCT01615484|Secondary|Recipient Mortality at 12 Months|Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.|12 months||||Participants|||Count of Participants
1365700|NCT01615484|Secondary|Day 7 Ventilator/ECMO Status|Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.|7 Days Post Transplant.||||Participants|||Count of Participants
1365701|NCT01615484|Secondary|ICU Length of Stay|The length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.|Time to Discharge, up to 30 days||||Days||Standard Deviation|Mean
1365702|NCT01615484|Primary|Primary Lung Graft Dysfunction (PGD)|"Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.~Grade 0: PaO2/FIO2 > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200."|24 and 72 hours||||Participants|||Count of Participants
1365703|NCT01615484|Primary|30 Day Mortality and Graft Survival|The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes.|30 Days||||Participants|||Count of Participants
1365704|NCT01615367|Secondary|Weekly Exercise Duration|Weekly exercise duration reported at post-treatment.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||minutes||Standard Deviation|Mean
1365705|NCT01615367|Secondary|Body Mass Index (BMI)|Body Mass Index levels at post-treatment.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||kg/m^2||Standard Deviation|Mean
1365731|NCT01615029|Secondary|Phase 2: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||Standard Deviation|Mean
1365706|NCT01615367|Secondary|Young Mania Rating Scale|Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient’s current symptoms of mania. The score for each item is summed for a total score that ranges from 0 to 56 with higher scores indicating more severe current manic symptoms.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||units on a scale||Standard Deviation|Mean
1365707|NCT01615367|Secondary|Montgomery Asberg Depression Rating Scale|Montgomery Asberg Depression Rating Scale is a 10-item clinician-rated measure of depression that assesses the presence and severity of patient’s current depressive symptoms. The score for each item is summed for a total score that ranges from 0 to 60 with higher scores indicating more severe current depressive symptoms.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||units on a scale||Standard Deviation|Mean
1365708|NCT01615367|Secondary|LIFE- Range of Impaired Functioning Tool|LIFE- Range of Impaired Functioning Tool assesses the extent to which medical burden has impacted current functioning. The score for each domain is summed for a total score that ranges from 4 to 20 with higher scores indicating worse functioning.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||units on a scale||Standard Deviation|Mean
1365709|NCT01615367|Primary|Client Satisfaction Questionnaire-8|"Client Satisfaction Questionnaire-8 is a reliable and valid self-report of participants’ acceptability of treatment. This is an assessment of client/patient satisfaction with their care and perceived quality and tolerability of NEW Tx. The scale for this item is a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The score for each item is summed for a total score that ranges from 8 to 32 with higher scores indicating greater acceptability of the treatment.TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period."|20 weeks|Participants in the treatment as usual condition were not required to complete this assessment if they did not elect to complete the NEW Tx intervention following the waitlist period. Participants completed this survey at the post-treatment visit only. Results only includes data from participants who completed the treatment and had data to report.|||units on a scale||Standard Deviation|Mean
1365710|NCT01615367|Primary|NEW Tx Scale|"NEW Tx Scale is a 10-item scale to asses participants’ expectations of NEW Tx their acceptability of NEW Tx at Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx. The scale for this item is a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The score for each item is summed for a total score that ranges from 10 to 50 with higher scores indicating poorer perception of the treatment. TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period."|20 weeks|Participants in the treatment as usual condition were not required to complete this assessment if they did not elect to complete the NEW Tx intervention following the waitlist period. Participants completed this survey at the post-treatment visit only. Results only includes data from participants who completed the treatment and had data to report.|||units on a scale||Standard Deviation|Mean
1365711|NCT01615328|Secondary|VAS of Neck Pain(Postoperative 6 Months)|"Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).~Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled “no pain (zero point)” at the far left and “greatest pain (ten point)” at the far right."|at 6 months after surgery (ACDF)||||scores on a scale||Standard Deviation|Mean
1365712|NCT01615328|Secondary|VAS of Radiating Pain (Postoperative 6 Months)|"Evaluation of radiating pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).~Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled “no pain (zero point)” at the far left and “greatest pain (ten point)” at the far right."|at 6 months after surgery (ACDF)||||scores on a scale||Standard Deviation|Mean
1365713|NCT01615328|Primary|Bone Fusion With CT(Postoperative 6 Months)|Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).|6 months after surgery(ACDF)||||participants|||Number
1365714|NCT01615263|Secondary|Use of Suction to Facilitate Lung Collapse||Up to 5 minutes after surgery||||participants|||Number
1365715|NCT01615263|Secondary|Opinion on the Device|20 minutes after pleural opening, the thoracic surgeon will give his opinion on the lung isolation device that was used on his patient (double lumen tube or bronchial blocker).|20 minutes after pleural opening||||percentage of right guess/opinion|||Number
1365716|NCT01615263|Secondary|Quality of Lung Collapse|"Assessment of lung collapse by the thoracic surgeon at 0, 5, 10 and 20 minutes after pleural opening.Visual analog scale of the quality of lung collapse will be assessed as the following:~No lung collapse~Partial lung collapse, not satisfactory~Partial lung collapse, satisfactory~Complete lung collapse"|From pleural opening to 20 minutes after||||percentage of patients|||Number
1365717|NCT01615263|Primary|Time to Obtain Complete Lung Collapse|For patients intubated with double lumen tube (DLT), clamping of the ipsilateral lumen without continuous positive airway pressure (CPAP) on the isolated lung will be done to allow lung collapse. The timer will be started at this moment and stopped 20 minutes after pleural opening. For patients of the bronchial blocker (BB) group, the first apnea period will of 30 seconds, keeping a pulse oximetry (SpO2) always over 97%, and under direct visualization with the FOB. Afterward, the cuff will be reflated and the timer will be started at this moment and stopped 20 minutes after pleural opening. For both groups, time of total lung collapse will be measured.|From the beginning of one lung ventilation to 20 minutes after pleural opening||||minutes||Standard Deviation|Mean
1365718|NCT01615198|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|14 weeks|Participants from the safety analysis set were analyzed. The safety analysis set included all randomized participants who received study medication and had post baseline assessments.|||Participants|||Number
1367913|NCT01591616|Secondary|Vital Signs (Diastolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose||||mmHg||Standard Deviation|Mean
1365719|NCT01615198|Secondary|Number of Participants Achieving Successful Response in msSBP and msDBP|Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.|4 weeks,10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||Participants|||Number
1365720|NCT01615198|Secondary|Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||Participants|||Number
1365721|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.|||mmHg||Standard Deviation|Mean
1365722|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.|||mmHg||Standard Deviation|Mean
1365723|NCT01615198|Secondary|Change From Baseline in Daytime and Nighttime maSBP/maDBP|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.|||mmHg||Standard Error|Least Squares Mean
1365724|NCT01615198|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.|Baseline, 4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at the given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
1365725|NCT01615198|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Participants from the full analysis set (FAS), who had both baseline and week 10 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
1365726|NCT01615198|Secondary|Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.|||mmHg||Standard Error|Least Squares Mean
1365727|NCT01615198|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.|Baseline, 4 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
1365728|NCT01615198|Secondary|Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.|||mmHg||Standard Error|Least Squares Mean
1365729|NCT01615198|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Only participants, who had both baseline and week 10 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
1365730|NCT01615029|Secondary|Phase 2: Overall Survival (OS)|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||95% Confidence Interval|Median
1365732|NCT01615029|Secondary|Phase 1: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.|Up to 3 years|Responders in all treated population analysis set included.|||Months||Standard Deviation|Mean
1365733|NCT01615029|Secondary|Phase 2: Progression-Free Survival (PFS)|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||95% Confidence Interval|Median
1365734|NCT01615029|Secondary|Phase 2: Duration of Response|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.|Up to 3 years|Responders in Intent-to-Treat (ITT) population analysis set included.|||Months||95% Confidence Interval|Median
1365735|NCT01615029|Secondary|Phase 2: Time to Progression (TTP)|TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of >=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||95% Confidence Interval|Median
1365736|NCT01615029|Primary|Phase 2: Percentage of Participants With Overall Response Rate (ORR)|ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|Up to 3 years|Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Percentage of participants||95% Confidence Interval|Number
1365737|NCT01615029|Primary|Phase 1: Percentage of Participants With Overall Response Rate (ORR)|ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|Up to 3 years|All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.|||Percentage of participants||95% Confidence Interval|Number
1365738|NCT01614886|Secondary|The Percentage of Treatment Retention.|Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings – 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline. Patients were analyzed according to the treatment group they were assigned to at randomization.|||Percentage of Participants|||Number
1365739|NCT01614886|Secondary|Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With “Improvement”: a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly|The J-CGIC is simple 7 grade investigator’s impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3.|4, 8, 12,16, 20 and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.|||Participants|||Number
1365740|NCT01614886|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE was used to measure severity of Alzheimer’s disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.|||Units on a scale||Standard Deviation|Mean
1365802|NCT01613599|Secondary|Incidence Rate of Adverse Events With Fatal Outcomes|Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365741|NCT01614886|Secondary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline, 8,16, and 24 weeks|Full analysis set (FAS): includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.|||Units on a scale||Standard Deviation|Mean
1365742|NCT01614886|Primary|Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation|The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline.|||Percentage of participants|||Number
1365743|NCT01614795|Secondary|Number of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment||Baseline|2 patients of the 12 patients enrolled in the Ewing Sarcoma stratum submitted specimens for analysis|||patients|||Number
1365744|NCT01614795|Secondary|Expression Levels of IGF-1R, Insulin Receptor, ERK, RON, and mTOR|Number of patients expressing insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) at levels 0, 1+, 2+, 3+ by immunohistochemistry.|Baseline|All specimens for the IHC analysis for IGF-1R, Insulin Receptor, ERK, RON, and mTOR were obtained prior to the start of treatment on ADVL1221. Levels 0, 1+, 2+ and 3+ represent increasing strengths of IHC staining.|||patients|||Number
1365745|NCT01614795|Secondary|Progression-free Interval|Percentage Probability of remaining progression-free 5 years after enrollment estimated by the method of Kaplan and Meier|10 months after enrollment|The 10 month time point was chosen since the shortest follow-up available was observed in Group 3 (relapsed or refractory rhabdomyosarcoma) where the last patient under observation was censored after completing 10 months of follow-up|||percent probability||95% Confidence Interval|Number
1365746|NCT01614795|Primary|Toxicity Associated With Chemotherapy|The number of patients-cycles where CTC Version 4 grade 3 or higher increased Alanine aminotransferase was observed|Duration of protocol therapy - Up to 25 cycles (700 days)|One hundred six (106) cycles were reported for the analysis of this toxicity|||cycles|||Number
1365747|NCT01614795|Primary|Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST).|We will consider the combination of sufficient activity if the true response rate is 35% or greater. .|6 cycles (168 days)|One (1) of the patients in Group 1 and one (1) of the patients in Group 4 were considered inevaluable for response assessment. One (1) of the patients in Group 2 was ineligible.|||participants|||Number
1365748|NCT01614769|Primary|Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery|The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.|||mg/dL||90% Confidence Interval|Least Squares Mean
1365749|NCT01614769|Primary|Rate of Recovery From Hypoglycemia to Euglycemia|The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.|||mg/dL/minute||90% Confidence Interval|Least Squares Mean
1365750|NCT01614769|Primary|Recovery Time From Hypoglycemia to Euglycemia|Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements >= 70 mg/dL, is called the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.|||Minutes||90% Confidence Interval|Least Squares Mean
1365751|NCT01614613|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects responded to statements about meter accuracy and diabetes management. Subject responses: 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'or No Response. □1ACCURACY HELPS 1A-with my ability to talk with my HCP. 1B-my satisfaction with my self monitoring of diabetes. 1C-with my ability to manage my diabetes. 1D-prevent low BG. 1E-understand how food/exercise affects low BG. □2 I WOULD USE ONLY the meter and strips my insurance company pays for, even if a more accurate meter was available. □3 I USE MY CURRENT METER BECAUSE 3A-my HCP gave it to me. 3B-my insurance company covers the strips. 3C-I think it is the most accurate meter. □4 I WOULD SWITCH meters for a more accurate meter. □5BEING ABLE TO APPLY MORE BLOOD IS IMPORTANT 5A-as I have wasted test strips by not having enough blood to fill the strip 5B-as this would save test strips 5C-I would switch to a meter with this feature|1 hour|Since subjects had the option to provide No Response at all to a question, some questionnaire statements had less than 146 participant responses possible (see numbers in parentheses)|||participants|||Number
1365752|NCT01614613|Secondary|Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)|Variability of each meter system was determined by calculating the Standard Deviation derived from each meter's differences between Blood Glucose Meter (BGMS)results and corresponding YSI Blood Glucose (BG) results.|6 hours|Same numbers (538) of BG results were possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 438 unmodified capillary samples and 100 samples were modified (21 to 496 mg/dL).|||Standard Deviation|Participants||Number
1365753|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL|"Using samples with BG >180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values was compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (231) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 181 unmodified capillary samples >180 mg/dL and 50 samples were modified by adding glucose solution.|||mg/dL|Participants|Standard Error|Least Squares Mean
1365754|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL|"Using samples with BG 70 mg/dL to 180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all|(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (172) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided all 172 capillary samples (70 to 180 mg/dL) and no samples were modified.|||mg/dL|Participants|Standard Error|Least Squares Mean
1365755|NCT01614613|Primary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)|"Using samples with BG < 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (135) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 85 unmodified capillary samples <70 mg/dL and 50 samples were modified by glycolyzing them.|||mg/dL|Participants|Standard Error|Least Squares Mean
1365756|NCT01614600|Primary|Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2|Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.|Baseline, Week 1, Week 2|Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.|||Units on a scale||Standard Deviation|Mean
1365757|NCT01614574|Secondary|Change From Baseline in CCL18 Levels||Baseline to week 51||||(ng/mL)||Standard Deviation|Mean
1365758|NCT01614574|Secondary|Change From Baseline in Plasma Chitotriosidase Levels||Baseline to week 51||||(nmol/mL/h)||Standard Deviation|Mean
1365759|NCT01614574|Secondary|Change From Baseline in Spleen Volume, Normalized to Body Weight||Baseline to week 51||||(% of Body Weight)||Standard Deviation|Mean
1365760|NCT01614574|Secondary|Change From Baseline in Liver Volume, Normalized to Body Weight||Baseline to week 51||||(% of Body Weight)||Standard Deviation|Mean
1365761|NCT01614574|Secondary|Change From Baseline in Platelet Count||Baseline to week 51||||(x 10`{super 9}/L)||Standard Deviation|Mean
1365762|NCT01614574|Secondary|Change From Baseline in Hemoglobin Concentration||Baseline to week 51||||(g/dL)||Standard Deviation|Mean
1365763|NCT01614574|Primary|Number of Patients With Concomitant Medication||Baseline to week 51||||participants|||Number
1365764|NCT01614574|Primary|Number of Infusion- Related Adverse Events||Baseline to week 51||||events|||Number
1365765|NCT01614574|Primary|Development of Anti-velaglucerase Alfa Antibody||Baseline to week51||||participants|||Number
1365766|NCT01614574|Primary|Number of Treatment Emergent Adverse Events (TEAE)||Baseline to week 51||||events|||Number
1365767|NCT01614574|Primary|Number of Severe Adverse Events (SAE)||Baseline to week 51||||events|||Number
1365768|NCT01614509|Primary|Changes of Central Retinal Thickness|Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection|baseline, 1, 3, 6 months after injection|Participants who were finished 6 months follow up period.|||micrometer||Standard Deviation|Mean
1365769|NCT01614509|Secondary|Additional Intravitreal Bevacizumab Injection|Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months|6 months|We evaluated mean times of additional intravitreal injection because of recurrent macular edema within participants who who were finished 6 months follow up periods.|||times of injection||Standard Deviation|Mean
1365787|NCT01614210|Other Pre-specified|Change in FACT-ES Symptom Scores|Patients were given the Functional Assessment of Cancer Therapy – Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 7 days following start of tamoxifen to assess quality of life while on tamoxifen. The difference in total score from baseline to 7 days was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.|7 days|Of the 50 patients enrolled, 46 had both pre and post FACT-ES total scores.|||change in units on a scale||Full Range|Median
1365770|NCT01614470|Secondary|Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 2: Week 20 up to Week 40|Safety Set for Part 2 included all subjects who received at least 1 dose of study drug (ivacaftor).|||participants|||Number
1365771|NCT01614470|Secondary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 1: From signing of informed consent up to Week 20|Safety Set for Part 1 included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||participants|||Number
1365772|NCT01614470|Secondary|Part 2: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through 24 Weeks of Treatment (Week 36 Visit)|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Change in CFQ-R respiratory domain score over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.|||units on a scale||Standard Deviation|Mean
1365773|NCT01614470|Secondary|Part 1: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 8|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||units on a scale||Standard Deviation|Mean
1365774|NCT01614470|Secondary|Part 2: Change From Baseline in Sweat Chloride Through 24 Weeks of Treatment (Week 36 Visit)|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Change in sweat chloride over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|"FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure. Here n signifies those subjects who were evaluable for this measure at given time point."|||mmol/L||Standard Deviation|Mean
1365775|NCT01614470|Primary|Part 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through 24 Weeks of Treatment (Week 36 Visit)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Absolute change in percent predicted FEV1 over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2, as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.|||percent predicted of FEV1||Standard Deviation|Mean
1365776|NCT01614470|Secondary|Part 1: Change From Baseline in Sweat Chloride Through Week 8|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||millimole per liter (mmol/L)||Standard Deviation|Mean
1365788|NCT01614210|Secondary|Correlation Between Changes in Ki67 and Symptoms|Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in Ki67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient.|7 days|Of the 50 patients enrolled Ki67 measurements were obtained for 44. Of the 44 patients which had a Ki67 result, 43 had both a pre and post symptom score.|||spearman correlation coefficient|||Number
1365777|NCT01614470|Secondary|Part 2: Change From Baseline in Body Mass Index (BMI) at 24 Weeks of Treatment (Week 36 Visit)|BMI was defined as weight in kg divided by height in m^2. Change in BMI over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.|||kg/m^2||Standard Deviation|Mean
1365778|NCT01614470|Secondary|Part 1: Change From Baseline in Body Mass Index (BMI) at Week 8|BMI was defined as weight in kilogram (kg) divided by height in meters^2 (m^2). Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||kg/m^2||Standard Deviation|Mean
1365779|NCT01614470|Primary|Part 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||percent predicted of FEV1||Standard Deviation|Mean
1365780|NCT01614457|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence, including clinically significant clinical laboratory assessments which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Baseline up to follow-up (3 to 4 weeks after last dose [last dose = Week 24])|Safety Set included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||participants|||Number
1365781|NCT01614457|Secondary|Time to First Pulmonary Exacerbation|Number of events (pulmonary exacerbation) during the pre-specified time intervals were reported. A subject without an exacerbation before withdrawal from the study was considered censored at the time of withdrawal, and a subject without an exacerbation who completes the study period was considered censored at the end of the analysis period.|Day 0 to 15, Day 16 to 56, Day 57 to 112, Day 113 to 168|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||events|||Number
1365782|NCT01614457|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated subject-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."|||units on a scale||Standard Error|Least Squares Mean
1365783|NCT01614457|Secondary|Change From Baseline in Sweat Chloride Through Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1365784|NCT01614457|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|Baseline, Week 24|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||kg/m^2||Standard Error|Least Squares Mean
1365785|NCT01614457|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years.|Baseline, Week 24|Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||percent predicted of FEV1||Standard Error|Least Squares Mean
1365786|NCT01614249|Primary|Change in BDI-II Depressive Symptom Scores|Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.|8 weeks|Only participants who completed the 8-weeks trial period were included in the final analysis of primary outcome. Per protocol analysis Post-intervention BDI-II scores at week 8 minus baseline BDI-II scores at week 0|||scores on BDI-II scale||95% Confidence Interval|Mean
1365789|NCT01614210|Secondary|Number of Participants With Long Term Endocrine Therapy Adherence|For the patient population on this study, endocrine therapy was indicated for 5 years post-surgery according to the current standard of care recommendations for hormone positive breast cancer. Endocrine therapy was prescribed as standard of care as appropriate for each patient’s situation. At 18 months post-surgery, patients were evaluated to determine if they were taking their endocrine therapy as prescribed.|18 months|Of the 52 patients enrolled on the study, 38 patients had data regarding long term endocrine therapy at 18 months post-surgery.|||participants adhering to therapy|||Number
1365790|NCT01614210|Secondary|Change in FACT-ES Symptom Scores|Patients were given the Functional Assessment of Cancer Therapy – Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 18 months following breast surgery to assess quality of life. The difference in total score from baseline to 18 months was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.|18 months|Of the 44 patients evaluable for the primary outcome measure, 35 completed both baseline and 18 month FACT-ES assessments|||change in units on a scale||95% Confidence Interval|Mean
1365791|NCT01614210|Primary|Change in Ki67 Expression in Tumors|Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.|7 days|3 were not evaluable due to rescheduling of surgery; 1 not evaluable due to pharmacy error. 2 patients had no invasive tumor on Ki-67 slides from pretreatment biopsy, and 2 patients had no invasive tumor on post-treatment surgery and were not evaluable.|||percentage change in Ki67||95% Confidence Interval|Mean
1365792|NCT01614093|Primary|Food Consumption After Intervention|"We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the Test Meal consumed 90 minutes after the preload."|90 minutes||||Grams||Standard Deviation|Mean
1365793|NCT01613768|Secondary|Toxicity Rates|Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0|Adverse events collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first.||||Participants|||Count of Participants
1365794|NCT01613768|Secondary|Disease Control Rate (DCR)|Complete response (CR) plus Partial response (PR) plus Stable disease (SD), summarized using frequencies and percentages|First dose of study therapy until disease progression, unacceptable toxicity or withdrawal of patient consent|All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.|||Participants|||Count of Participants
1365795|NCT01613768|Secondary|Time to Progression|First dose of study therapy to the first date of radiographic progression of disease (PD)|First dose of study therapy to the first date of radiographic progression of disease (PD)|All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. Does not include 7 patients taken off study before radiological progression: Toxicity = 3, Clinical PD = 4.|||Weeks||Full Range|Median
1365796|NCT01613768|Secondary|Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)|Date of the first objective assessment of CR or PR to the first date of disease relapse or death from any cause, reported as median values.|Date of first objective assessment CR or PR to the first date of disease relapse or death from any cause|Participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline who achieved a CR or PR per RECIST 1.1.|||weeks||Full Range|Median
1365797|NCT01613768|Primary|Response Rate|Response Rate as defined by RECIST 1.1 criteria, summarized using frequencies and percentages.|First dose of study therapy until disease progression, unacceptable toxicity or withdrawal of patient consent|All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.|||Participants|||Count of Participants
1365798|NCT01613716|Primary|Visual Acuity|ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.|3 months|23 of the participants were able to come in for their 3 month appointment per protocol|||ETDRS||Full Range|Median
1365799|NCT01613716|Primary|Central Retinal Thickness|At 3 months, central retinal thickness as measured by optical coherence tomography will be measured|3 months|Optical Coherence Tomography was collected at 3 months. 22 of the patients were seen at month 3.|||micrometers||Full Range|Median
1365800|NCT01613599|Secondary|Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab|A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365801|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab|A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365803|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events|A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365804|NCT01613599|Secondary|Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer|Malignancies were clinical findings of cancer and excluded non-melanoma skin cancer. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365805|NCT01613599|Secondary|Incidence Rate of Serious Vascular Adverse Events|A serious vascular adverse event was defined as a SAE coded to the MedDRA vascular system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365806|NCT01613599|Secondary|Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion|A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above.|From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||percentage of participants|||Number
1365807|NCT01613599|Secondary|Incidence Rate of Serious Cardiac Adverse Events|A serious cardiac adverse event was defined as a SAE that was coded to the Medical Dictionary for Regulatory Activities (MedDRA) cardiac system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365808|NCT01613599|Secondary|Percentage of Participants With a Serious Infusion-related Reaction|A serious infusion-related reaction was defined as a SAE during or within 24 hours after any rituximab infusion and considered infusion related by the Principal Investigator. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above.|From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||percentage of participants|||Number
1365809|NCT01613599|Primary|Incidence Rate of Serious Infections|A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
1365810|NCT01613417|Secondary|Accuracy for Tumor Characterization|Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment|5-10 minutes Postdose|Subjects with histologically confirmed lesions|||participants|||Number
1365811|NCT01613417|Secondary|Lesion Detection|Lesion detection rate by contrast agent and reader|5-10 minutes Postdose|Per protocol patients with histologically confirmed lesions|||participant exams|||Number
1365812|NCT01613417|Secondary|Percentage Signal Intensity Enhancement on Postdose Images|Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population|||percentage signal intensity enhancement|Participants|Standard Deviation|Mean
1365814|NCT01613417|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
1365815|NCT01613417|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
1365816|NCT01613417|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
1365817|NCT01613417|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
1365818|NCT01613417|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations|||participant exams|Participants||Number
1365819|NCT01613378|Secondary|Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months|"The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud’s phenomenon, secondary Sjogren’s syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded YES to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable"|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.|||participants|||Number
1365820|NCT01613378|Secondary|Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months|The extra-articular RA manifestations ascertained were the nodules, Raynaud’s phenomenon, secondary Sjogren’s syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data.|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.|||percentage of participants|||Number
1365821|NCT01613378|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the ESR assessment were included in this analysis.|||mm/hr||Standard Deviation|Mean
1365822|NCT01613378|Secondary|Change From Baseline in C-Reactive Protein (CRP)|The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the CRP assessment were included in this analysis.|||mg/L||Standard Deviation|Mean
1365823|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Patient Assessment of Fatigue on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
1365824|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Pain on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
1365825|NCT01613378|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
1365858|NCT01613248|Secondary|Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose|Photophobia is sensitivity to bright light.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365826|NCT01613378|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
1365827|NCT01613378|Secondary|Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Duration of Morning Stiffness on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
1365828|NCT01613378|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the DAS28 assessment were included in this analysis.|||units on a scale||Standard Deviation|Mean
1365829|NCT01613378|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Swollen Joint Count were included in this analysis.|||swollen joints||Standard Deviation|Mean
1365830|NCT01613378|Secondary|Change From Baseline in Tender Joint Count (TJC)|Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Tender Joint Count were included in this analysis.|||tender joints||Standard Deviation|Mean
1365831|NCT01613378|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||At 6 months|All participants enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
1365832|NCT01613339|Secondary|Activities-specific Balance Confidence Scale|16 item questionnaire that investigates balance self-efficacy. Each items is a question; How secure are you that you will not fall when you...sweep the floor? The participant are asked to grade his/hers feeling of secutiry from 0, 10, 20 and so on up to 100. 0 is regarded low balance self-efficacy. The item responses are summed and divided by 16.|Change from baseline in Activities-specific Balance confidence scale at 9 weeks||||units on a scale||Standard Deviation|Mean
1365833|NCT01613339|Primary|Bergs Balance Scale|"Test of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0.~The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance."|Change from baseline in Bergs balance scale at 9 weeks||||units on a scale||Standard Deviation|Mean
1365834|NCT01613339|Secondary|Timed Up and Go Test|test of functional mobility. Time is taken in seconds. The participants sits on a chair with armrests are then asked to rise, walk 3 meters, turn and walk back and sit down.|Change from baseline in Timed Up and Go test at 9 weeks||||seconds||Standard Deviation|Mean
1365835|NCT01613326|Secondary|Mean Daily, Daytime and Nighttime (Combined) Symptom Scores Over the 12 Week Treatment Period|Participants completed eDiaries providing scores 0 to 3 for symptoms: Cough and wheeze (none, mild, moderate, severe); sputum volume (none, less than 5 mL, 5-25 mL, >25 mL); sputum color (none, white-grey, yellow, green); lowest level of activity causing breathlessness (never or only when running, when walking uphill or upstairs, when walking on flat ground, at rest). Symptoms in the morning, for the previous night (no waking due to symptoms, woke up once due to symptoms, woke up more than once due to symptoms, woke up frequently or could not sleep due to symptoms). Symptoms experienced during the day that had prevented them for performing normal activities (not at all, a little, quite a lot, completely). The mean change from baseline in the total scores and in the individual scores was summarized by treatment. Only participants with a value at both baseline and post-baseline were included. Possible total scores 0-18 (night); 0-36 (day). A higher score means worsening of symptoms.|12 weeks|The per-protocol set included all randomized patients who received at least one dose of study drug. Only patients with a value at both baseline and post-baseline are included.|||units on a scale||Standard Deviation|Mean
1365836|NCT01613326|Secondary|Event Free Rate at Weeks 4, 8 and 12 After Treatment|Event free rate was calculated as a percentage of participants who did not experience any moderate or severe COPD exacerbation leading to hospitalization/treatment with systemic corticosteroids/treatment with antibiotics. The event free rate reflects the percent of patients who did NOT have an exacerbation by 4, 8 and 12 weeks. Event-free rates are calculated at the end of the specified weeks (i.e. Day 29, Day 57 and Day 85) by the Kaplan Meier method.|Weeks 4, 8 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations and described as patients with moderate to severe exacerbations were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
1365837|NCT01613326|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (5 Min-4 h) Post-dose|"Forced Expiratory Volume in one second (FEV1) was measured with spirometry conducted according to internationally accepted standards.~Area Under the Curve (AUC) is calculated using the trapezoidal rule using the existing FEV1 measurements (i.e., the missing FEV1 measurements are not interpolated).~ANCOVA model: FEV1 AUC = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.|||Liters||Standard Error|Least Squares Mean
1365838|NCT01613326|Secondary|Forced Vital Capacity (FVC) at Each Time-point by Visit|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. ANCOVA model: FVC = treatment + baseline FVC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
1365839|NCT01613326|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Each Time-point by Visit|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) model: FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
1365840|NCT01613326|Secondary|Inspiratory Capacity (IC) at Each Time-point, by Visit|IC was measured with spirometry conducted according to internationally accepted standards. ANCOVA model: IC = treatment + baseline IC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Day 1), (-20 min, 25 min, 23 h 40 min Week 4),(-20 min, 25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
1365841|NCT01613326|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) During 5 Min to 4 Hours Post-dose, at Day 1 and Week 12|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded during first 4 hours post dose. ANCOVA model: Peak FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). Center is included as a random effect nested within region. This analysis excludes values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|5 min to 4 hours post-dose at Day 1 and Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
1365842|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 4|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.~Trough FEV1 is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. Trough assessments taken outside 22 h 45 min - 24 h 15 min are excluded from this analysis.~ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and Week 4|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.|||Liters||Standard Error|Least Squares Mean
1365843|NCT01613326|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 12 Week Treatment|"A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.~Baseline mean daily, daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs. Only patients with a value at both baseline and post-baseline visits were included."|Baseline and Day 1 to Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with a value at both baseline and post-baseline visits were included.|||puffs||Standard Deviation|Mean
1365844|NCT01613326|Secondary|St. George's Respiratory Questionnaire Total Score After 12 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. ANCOVA model: SGRQ total score = treatment + baseline SGRQ score + baseline ICS use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region).|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.|||Units on a scale||Standard Error|Least Squares Mean
1365845|NCT01613326|Secondary|Transition Dyspnea Index (TDI) Focal Score After 4 Weeks and 12 Weeks of Treatment|"Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.~ANCOVA model: TDI focal score = treatment + Baseline dyspnea index (BDI) + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Weeks 4 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.|||Units on a scale||Standard Error|Least Squares Mean
1365859|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose|Phonophobia is sensitivity to loud sounds.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365846|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Analysis of Superiority)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and had available data for analysis.|||Liters||Standard Error|Least Squares Mean
1365847|NCT01613326|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23hours 15min and 23 hours 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.|||Liters||Standard Error|Least Squares Mean
1365848|NCT01613313|Secondary|Relative Change in Volume of the Lipoma|A secondary outcome is the relative change in volume of the lipoma as determined by MRI. This outcome will be analyzed as the change from baseline to 6 months post injection.|Baseline and 6 months post injection of study drug|Analysis is based on the population that consists of all subjects who are enrolled and received administration of study drug|||Percent reduction from baseline||Standard Deviation|Mean
1365849|NCT01613313|Primary|Change in Visible Surface Area of the Lipoma|The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.|Baseline and Six months post injection of study drug|Analysis population consists of all subjects who were enrolled and received the administration of study drug.|||Percent change from baseline||Standard Deviation|Mean
1365850|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose|TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365851|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose|TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365852|NCT01613248|Secondary|Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365853|NCT01613248|Secondary|Percentage of Participants Reporting SPR 2-48 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365854|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365855|NCT01613248|Secondary|Percentage of Participants Reporting SPF 2-48 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365856|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365857|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose||2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365860|NCT01613248|Primary|Number of Participants Who Discontinued From Study Due to Adverse Events||Up to 5 weeks post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.|||participants|||Number
1365861|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 14 Days Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 14 days post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.|||participants|||Number
1365862|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 48 hours post-dose|All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment.|||participants|||Number
1365863|NCT01613248|Primary|Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose|PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365864|NCT01613248|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose|PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1365865|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365866|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365867|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365868|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 90|4 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365869|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365870|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365871|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 140|5 women in the Mirena + Estradiol Gel arm, and 7 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365872|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365873|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 0|One woman in the Mirena + Placebo Gel arm did not provide complete data for this outcome measure; thus she was not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365874|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 0|Two women in the Mirena + Placebo Gel did not provide complete data for this outcome measure; thus they were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
1365875|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 0||||scores on a scale||Standard Error|Mean
1365876|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 0||||scores on a scale||Standard Error|Mean
1365877|NCT01613027|Secondary|Percentage of Serious ADRs|"Percentage of serious ADRs resolved and ongoing at the time of study completion was reported.~An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of serious ADRs|Participants||Number
1365878|NCT01613027|Secondary|Percentage of Serious AEs|"Percentage of serious AEs resolved and ongoing at the time of study completion was reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of serious AEs|Participants||Number
1365879|NCT01613027|Secondary|Percentage of Non-Serious ADRs|"Percentage of non-serious ADRs at the time of study completion was reported.~An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of non-serious ADRs|Participants||Number
1365880|NCT01613027|Secondary|Percentage of Non-Serious AEs|"Percentage of non-serious AEs resolved and ongoing at the time of study completion were reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of non-serious AEs|Participants||Number
1365881|NCT01613027|Secondary|Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity|"Percentage of participants with any non-serious AE and any serious AE by intensity (mild, moderate, severe) was reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants|||Number
1365882|NCT01613027|Secondary|Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. AEs of special interest includes progressive multifocal leukoencephalopathy (PML), any encephalopathy, hepatitis B or hepatitis B reactivation, gastrointestinal perforation, tuberculosis (TB) or TB reactivation, opportunistic infections, and malignancies.|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants|||Number
1365883|NCT01613027|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ)|"The M-HAQ is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.~Clinically meaningful improvement was defined as minimum clinically significant reduction from baseline of ≥0.22 at the respective time point."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data for change from baseline at Month 6 and Month 12 are included for participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
1365884|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 12|Reasons for discontinuation from baseline to Month 12 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||participants|||Number
1367914|NCT01591616|Secondary|Vital Signs (Systolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.||||mmHg||Standard Deviation|Mean
1365885|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 6|Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 6|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||participants|||Number
1365886|NCT01613027|Secondary|Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12||Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants|||Number
1365887|NCT01613027|Secondary|Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5.0 milligrams per liter (mg/L). A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data at Month 6 and Month 12 are included for participants who had assessments for CRP.|||mg/L||Standard Deviation|Mean
1365888|NCT01613027|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||mm/hour||Standard Deviation|Mean
1365889|NCT01613027|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||tender joints||Standard Deviation|Mean
1365890|NCT01613027|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12|SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||swollen joints||Standard Deviation|Mean
1365891|NCT01613027|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Month 6, and baseline and Month 12, and reported as the percentage of participants with response overall, good response, moderate response, and no response measured at each time point. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants||95% Confidence Interval|Number
1365892|NCT01613027|Primary|Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12|DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient’s global assessment of disease activity (100-millimeter [mm] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||units on a scale||Standard Deviation|Mean
1365893|NCT01613014|Primary|Weekly Percentage of Heaving Drinking Days|"The primary objective of this study is to assess the efficacy of ABT-436 to reduce the weekly percentage of heavy drinking days (reduction in drinking) in subjects with alcohol dependence confirmed by DSM-IV-TR criteria. A “heavy drinking day” is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.~The outcome measure was averaged across weeks 2-12."|Weeks 2-12|Models are based on a mITT population that included subjects who received at least one dose of medication (N=144; ABT-436=73, placebo=71). One additional placebo subject had no drinking data during the maintenance period, and one ABT-436 subject was missing data on a baseline covariate, resulting in an analyzable N=142 (ABT-436=72, placebo=70).|||weekly percentage of heavy drinking days||95% Confidence Interval|Least Squares Mean
1365894|NCT01612884|Secondary|Number of Participants With Bleeding Events|Major or Minor Bleeding according to TIMI criteria|6 months||||Participants|||Count of Participants
1365895|NCT01612884|Secondary|Number of Participants With Ischemic Events|Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention|6 months||||Participants|||Count of Participants
1365896|NCT01612884|Primary|Thrombelastography (TEG) MA|Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel|1 day|TEG-MA (mm) at 16-24 hours outcome measure|||mm||Standard Deviation|Mean
1365897|NCT01612858|Secondary|Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent|Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy|12 weeks|Only participants with baseline and post insulin sensitizing treatment magnetic resonance spectrosocpy were included in this analysis.|||percentage of hepatic fat||Standard Deviation|Mean
1365898|NCT01612858|Primary|Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent|Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone|3 months|Only participants with baseline and post insulin-sensitizing treatment euglycemic-hyperinsulinemic clamp were included in this analysis|||mg/kg lean body mass/min||Standard Deviation|Mean
1366356|NCT01607853|Secondary|Change From Baseline in Erythema at Day 18|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18||||units on a scale||Standard Deviation|Mean
1365899|NCT01612767|Secondary|Angina Pectoris Classification|"Evaluate the angina pectoris classification at each study visit.~Stable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest~Unstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction"|Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
1365900|NCT01612767|Secondary|Lesion Success During the Index Procedure|Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.|Index procedure||||Percentage of participants|||Number
1365901|NCT01612767|Secondary|Device Success During the Index Procedure|Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.|Index procedure||||Percentage of participants|||Number
1365902|NCT01612767|Secondary|Index Procedure Success|Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.|Index procedure||||Percentage of participants|||Number
1365903|NCT01612767|Secondary|Stent Thrombosis Rate|Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants||95% Confidence Interval|Number
1365904|NCT01612767|Secondary|All-cause Mortality and All-cause MI - Contribution of Individual Rates|Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
1365905|NCT01612767|Secondary|Composite of All-cause Mortality and All-cause MI|Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants||95% Confidence Interval|Number
1365906|NCT01612767|Secondary|Overall Target Lesion Revascularization Rate|Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants||95% Confidence Interval|Number
1365907|NCT01612767|Secondary|Target Lesion Failure Rate - Contribution of Individual Event Types|The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
1365908|NCT01612767|Secondary|Overall Target Lesion Failure Rate|Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants||95% Confidence Interval|Number
1365909|NCT01612767|Secondary|Overall Target Vessel Revascularization Rate|Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants||95% Confidence Interval|Number
1365910|NCT01612767|Secondary|Target Vessel Failure Rate - Contribution of Individual Event Types|Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.|1, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
1365911|NCT01612767|Secondary|Target Vessel Failure Rate|Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.|1, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants||95% Confidence Interval|Number
1365912|NCT01612767|Primary|Target Vessel Failure Rate|The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.|9 months post-index procedure||||Percentage of participants||95% Confidence Interval|Number
1365913|NCT01612702|Secondary|Wound Complication|Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.|within 30 days after surgery||||participant|||Number
1365914|NCT01612702|Secondary|Pain Level|A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).|6 to 24 hours after surgery||||units on a scale||Standard Deviation|Mean
1365915|NCT01612702|Primary|Incidence of Nausea and Vomiting|A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting|within 72 hours after surgery||||percentage of participant||95% Confidence Interval|Number
1365916|NCT01612676|Secondary|Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram|Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).|Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion|The safety analysis set comprised of all allocated and dosed patients and were analyzed according to the actual dosing regimen received.|||patients|||Number
1365917|NCT01612676|Secondary|Mortality|Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||patients|||Number
1365918|NCT01612676|Primary|Time to Septic Shock Resolution|"The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration.~Time to all but one patient out of septic shock is presented."|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||Hours|||Number
1365919|NCT01612676|Primary|Infusion Rate of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.|||µg/kg/min||Standard Deviation|Mean
1365920|NCT01612676|Primary|Cumulative Dose of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.|||µg/kg||60% Confidence Interval|Mean
1365921|NCT01612676|Primary|Infusion Rate of FE 202158|Infusion rate of FE 202158 was presented from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||ng/kg/min||Standard Deviation|Mean
1365922|NCT01612676|Primary|Cumulative Dose of FE 202158|Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||ng/kg||60% Confidence Interval|Mean
1365923|NCT01612676|Secondary|Graded Morbidity|Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||patients|||Number
1365924|NCT01612676|Secondary|Morbidity Assessment|Percentage of all the “Days alive and out/free of” intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||percentage of days within 28 days|||Number
1365925|NCT01612676|Secondary|Summary of Investigator Reported Outcomes|Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.|Day 1 up to Day 2|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||Score on scale||Standard Deviation|Mean
1365926|NCT01612676|Secondary|Fluid Balance|The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.|Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||mL/kg||60% Confidence Interval|Mean
1365927|NCT01612676|Secondary|Urinary Output|The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.|Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||mL/kg||60% Confidence Interval|Mean
1365928|NCT01612676|Primary|Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine|Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||Percentage of patients||60% Confidence Interval|Number
1365929|NCT01612546|Secondary|Incidence of Adverse Events|Incidence of treatment related adverse events graded per NCI CTCAE version 4.03|Up to 4 years||||participants|||Number
1365930|NCT01612546|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From date of start of therapy to date of death due to any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
1365931|NCT01612546|Secondary|Clinical Benefit Rate|Patients with a best response of Complete Response, Partial Response or Stable Disease after at least 4 months of treatment assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), not a CR, PR, Progression or Symptomatic Deterioration; Progression (PD), a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Symptomatic Deterioration, global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Clinical Benefit (CR + PR +SD≥4months).|At least 4 months post treatment, assessed up to 4 years||||percentage of participants|||Number
1365932|NCT01612546|Secondary|Overall Objective Response Rate|Patients with best response of Complete Response or Partial Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 years||||percentage of participants|||Number
1365933|NCT01612546|Primary|CRLX101 (CPT) Uptake in Tumor and Nearby Normal Tissue|Using Fisher's Exact to determine statistical significance in detection of a CPT fluorescence signal posttreatment between tumor and adjacent normal tissue biopsy specimens.|Baseline and day 8|One patient was not included in the analysis because no tumor tissue was identified in the biopsy samples both pre and post-CRLX101 treatment.|||Participants|||Count of Participants
1365934|NCT01612494|Secondary|Change in Nausea and Vomiting||from initial symptoms to 2-3 days post discharge|||||||
1365935|NCT01612494|Primary|Change in Pain|Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.|Following therapy to 2-3 days post discharge||||units on a scale||Standard Deviation|Mean
1365936|NCT01612351|Secondary|Describe the Kinome Response to Induction Chemotherapy (Lapatinib, Paclitaxel, and Carboplatin) in Patients Who Consent to This Optional Evaluation Via Co-enrollment in LCCC0121||11 weeks|||||||
1365937|NCT01612351|Secondary|Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0|The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|18 weeks||||Participants|||Count of Participants
1365938|NCT01612351|Secondary|Response Rates at Both the Primary Site and in the Neck.|Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|11 weeks|||||||
1365939|NCT01612351|Secondary|Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy|Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|11 weeks|||||||
1365940|NCT01612351|Secondary|Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL)|The Voice-Related Quality of Life Tool is a 10 item list of possible voice-related problems. The participant answers 1-5 with 1 being none, not a problem to 5, problem is as bad as it can be. An algorithm is used to calculate the scores, so that sum scores range from 0 to 100, where 0 indicates poor V-RQOL and 100 indicates good V-RQOL|Pre-treatment up to 1 year post surgery|Patients were encouraged to complete the assessment but at their discretion. Participants with data available reported.|||units on a scale||Standard Deviation|Mean
1366357|NCT01607853|Secondary|Change From Baseline in Erythema at Day 15|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15||||units on a scale||Standard Deviation|Mean
1365941|NCT01612351|Secondary|Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI)|The MD Anderson Dysphagia Inventory (MDADI) is a 20 item assessment designed to measure voice and swallowing function. Participants were asked 13 symptom questions and 6 interference items (walking, working) and asked id the 1- strongly agree to 5 strongly disagree. Scores were summed for a range of 20-100. The lower the score the worse the outcomes.|Pre-treatment up to 1 year post surgery|Subjects were encouraged to complete the assessments but it was left to their discretion. Participants with data available reported.|||units on a scale||Standard Deviation|Mean
1365942|NCT01612351|Secondary|Progression-Free Survival|"Progression-free survival associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation. Defined as per RECIST criteria. Physical examination, imaging of target lesions by CT scan or MRI and chest imaging (CT or Chest x-ray, if clinically indicated) every 3 months (+/- 30 days) for 18 months following end of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|15 years|||||||
1365943|NCT01612351|Secondary|Overall Survival|Overall survival is measured from the time the patient goes on treatment until death.|15 years|||||||
1365944|NCT01612351|Secondary|Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.|Number of patients who no longer need radiation (have decreases in risk level post induction therapy). Estimations of Risk level pre-induction will be based on physical examination and imaging, post-induction risk level will be determined based on pathologic evaluation or surgical specimen.|11 weeks|One patient withdrew before surgery.|||Participants|||Count of Participants
1365945|NCT01612351|Secondary|Feasibility of 3 Part Therapy|Percentage of patients successfully completing 3 part therapy will be used to assess the feasibility of 3 part therapy consisting of induction chemotherapy, surgery, and risk-adapted use of chemoradiation.|2 years|||||||
1365946|NCT01612351|Primary|Overall Response Rate|Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|11 weeks||||Participants|||Count of Participants
1365947|NCT01612221|Secondary|Transcriptional Markers of UV-induced Oxidative Stress in Nevi|Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi|3.5 years|One subject with low-risk MC1R randomized to drug was excluded because the lesions removed were seborrheic keratoses and not nevi.|||markers of UV-induced oxidative stress||Standard Deviation|Mean
1365948|NCT01612221|Primary|UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi|Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.|3.5 years|One subject with low-risk MC1R randomized to drug was excluded from both analyses because the lesions removed were seborrheic keratoses and not nevi, and 2 subjects (one high-risk MC1R randomized to drug and one low-risk MC1R randomized to placebo) were excluded from analysis of 8-OG because there was insufficient tissue.|||percentage of 8-OG expression in nevi||Standard Deviation|Mean
1365949|NCT01612156|Secondary|Embarrassment With Pelvic Floor Examination|The participants will be asked to report their level of embarrasment during the exam using a Likert scale from 1 (no embarrassment) to 5 (most embarrasment possible) at 30 minutes after completion of the exam.|30 minutes||||On 5 point Likert scale||Full Range|Median
1365950|NCT01612156|Primary|Pain During the Pelvic Floor Examination|"Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam.~The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible)."|30 minutes after completion of exam||||units on Wong Baker pain scale||Standard Deviation|Mean
1365951|NCT01612000|Primary|The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.||42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.|||titer||95% Confidence Interval|Geometric Mean
1365952|NCT01612000|Secondary|Long-term Safety|Incidence of Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCIs) and Adverse Events of Special Interest (AESIs) over 12 months following vaccination. Study subjects were followed every three months (for one year following Day 42) by telephone and visit for reports of SAEs, NOCIs, and AESIs.|13 Months|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.|||participants|||Number
1365953|NCT01612000|Secondary|Reactogenicity Immediately After Each Injection, Extending to Day 7.|Solicited events of local and systemic reactogenicity Days 0-7. These events are expected to occur and not considered or recorded as Adverse Events.|7 Days|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.|||participants|||Number
1365954|NCT01612000|Primary|The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.|42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.|||percentage of participants||95% Confidence Interval|Number
1365972|NCT01611883|Secondary|"Percentage of Participants With Adverse Event (AE) Exacerbation of Diabetes"|The Investigator took into account a participant’s index of blood glucose control, diabetes medications, and compliance to diet and exercise therapy to assess overall control of the participant’s diabetes and to determine if the participant’s diabetes worsened. Participants who experienced the AE “Exacerbation of Diabetes ” (verbatim term) were recorded.|up to 24 weeks|All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1365955|NCT01611974|Secondary|Half-Life (T½) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||hours||Standard Deviation|Mean
1365956|NCT01611974|Secondary|Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||h*ug/mL||Standard Deviation|Mean
1365957|NCT01611974|Secondary|Time of Last Non-Zero Concentration (Tlast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||hours||Standard Deviation|Mean
1365958|NCT01611974|Secondary|Time to Maximum Concentration (Tmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||hours||Standard Deviation|Mean
1365959|NCT01611974|Secondary|Maximum Concentration (Cmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations|||ug/mL||Standard Deviation|Mean
1365960|NCT01611974|Secondary|Time to CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time of the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA after achievement of undetectable plasma CMV DNA in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1; as assessed by the central laboratory. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. The median values are Kaplan-Meier estimates.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||days||95% Confidence Interval|Median
1365973|NCT01611883|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
1365961|NCT01611974|Secondary|Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time from first dose of study drug to first undetectable plasma CMV DNA within 6 weeks and at any time during the study, defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days; as assessed by the central laboratory. The median values are Kaplan-Meier estimates.|6 weeks after start of treatment, within 36 weeks of start of treatment|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||days||95% Confidence Interval|Median
1365962|NCT01611974|Secondary|Number of Participants With CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. CMV recurrence was defined as achievement of undetectable plasma CMV DNA at any time after Day 1 in at least 2 consecutive samples separated by at least 5 days, followed by detectable plasma CMV DNA in at least 2 consecutive samples separated by at least 5 days (assessed by the central laboratory). For the analyses of CMV recurrence, the first of 2 consecutive confirmed undetectable plasma CMV DNA results had to be on-treatment. CMV DNA PCR values of ≥200 copies/mL were considered detectable. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1365963|NCT01611974|Primary|Number of Participants With a Treatment Emergent Adverse Event (TEAE).|Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug.|25 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1365964|NCT01611974|Primary|Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by >/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).|6 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1365965|NCT01611948|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).|Week 0 and Week 8|Two participants in the matched placebo arm who completed the double blind portion of the trial were unable to be analyzed for change in Urinary CN-THCCOOH Level due to missing data at Week 0 and/or Week 8. One sample was missing source documentation while the other sample was too dilute to return a reliable measurement.|||ng/mg||Standard Deviation|Mean
1365966|NCT01611883|Secondary|Percent Change in Non–HDL-cholesterol From Baseline|Non-HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
1365967|NCT01611883|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline|HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
1365968|NCT01611883|Secondary|Percent Change in Triglycerides From Baseline|Triglycerides levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
1365969|NCT01611883|Secondary|Percent Change in Total Cholesterol (TC) From Baseline|TC levels measured at Baseline and after 24 weeks of treatment.|Baseline and Week 24|FAS defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
1365970|NCT01611883|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline|LDL-C levels measured at baseline and after 24 weeks of treatment|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
1365971|NCT01611883|Secondary|Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes|The percentage of participants who had changes to their medications used to treat their diabetes, other than small changes in insulin dosing (± 5 Units), were reported and summarized.|Up to 24 weeks|AST Population defined as all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1365974|NCT01611883|Secondary|Change in Glycoalbumin From Baseline|Glycoalbumin is a blood marker used to assess blood glucose control over time and is reported as a percentage (%). Serum glycoalbumin levels were assessed at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.|||Percent||95% Confidence Interval|Least Squares Mean
1365975|NCT01611883|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline|HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.|||Percent||95% Confidence Interval|Least Squares Mean
1365976|NCT01611857|Secondary|Time to Progression in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until progressive disease, expected 18 months.|The analysis was performed on all participants (N = 34) in the Phase II portion of the study.|||months||95% Confidence Interval|Median
1365977|NCT01611857|Secondary|Overall Survival in Phase II Dose Expansion|Defined as the time from first treatment until death from any cause.|every 8 weeks until treatment discontinuation, an expected average of 18 months, then every 12 weeks thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N=34) for all participants in the Phase II portion of the study.|||months||95% Confidence Interval|Median
1365978|NCT01611857|Secondary|Progression Free Survival in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until treatment discontinuation, projected 18 months and then every 3 months thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N = 34) for all participants in the Phase II portion of the study. Median follow-up was 15 months (3-21 months)|||months||95% Confidence Interval|Median
1365979|NCT01611857|Primary|The Incidence of Dose Limiting Toxicities (DLT) in Phase I Dose Escalation|Using a standard 3+3 design participants were enrolled in dose-escalating cohorts to determine the maximum tolerated dose (MTD) of tivantinib when given with FOLFOX (5-FU 400 mg/m^2, continuous IV 5-FU 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2). MTD is defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.|14 Days (1 cycle)|Patients were assessed for DLT if they received at least 85% of the scheduled doses of study drugs in cycle 1. In the Tivantinib 120 mg cohort two participants were replaced due to missed drug. In the Tivantinib 360 mg cohort one patient was replaced due to an allergic reaction to oxaliplatin.|||participants|||Number
1365980|NCT01611792|Primary|Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|11 weeks and 6 months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
1365981|NCT01611792|Primary|Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|Baseline and 6 months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
1365982|NCT01611792|Primary|Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|Baseline and 11 weeks|Based on data reported and available|||units on a scale||Standard Deviation|Mean
1365983|NCT01611792|Primary|Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement|11 Weeks and 6 Months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
1365984|NCT01611792|Primary|Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement|Baseline and 6 Months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
1365985|NCT01611792|Primary|Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)|Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement|Baseline and 11 weeks|Based on data reported and available|||units on a scale||Standard Deviation|Mean
1365986|NCT01611779|Secondary|Epworth Sleeping Scale (ESS)|0 to 24 (high value represents worse outcome)|Baseline, 1, 3, 12 months|Five (5) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 4 had follow-up data at 3 months, and 2 had follow-up data at 12 months.|||units on a scale||Standard Deviation|Mean
1365987|NCT01611779|Secondary|Snoring Scale (VAS)|0 to 10 (high value represents worse outcome)|Baseline, 1 week; 1 month, 3 months, 12 months|Four (4) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 3 had follow-up data at 3 months, and 2 had follow-up data at 12 months.|||units on a scale||Standard Deviation|Mean
1365988|NCT01611779|Secondary|Functional Outcomes and Sleep Questionnaire (FOSQ)|Questionnaire: 0 to 120 (high value represents better outcome)|Baseline, 1, 3, 12 months|Four (4) of 5 total subjects had data at baseline and follow-up data.|||units on a scale||Standard Deviation|Mean
1365989|NCT01611779|Secondary|Apnea Hypopnea Index|0 to >30/hour (high value represents worse outcome)|Baseline, 3, and 12 months|Three (3) of 5 subjects returned for 3 month follow-up and 2 of 5 subjects returned for the 12 month follow-up.|||events/hour||Standard Deviation|Mean
1365990|NCT01611779|Primary|Number of Participants Experiencing Complications|Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.|3 months||||Participants|||Count of Participants
1365991|NCT01611779|Primary|Place the Implant and Stabilize the Tongue|Ability to place the implant and stabilize the tongue|Up to 7 weeks after the procedure||||Participants|||Count of Participants
1365998|NCT01611558|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|From first dose to within 90 days of last study dose|All participants who received at least 1 dose of study drug|||Participants|||Number
1365999|NCT01611558|Secondary|Best Overall Response Rate (BORR)|BORR is defined as the percentage of participants who received treatment and, at any time during the study, had a best response of complete response or partial response, as confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria for patients with cancer antigen 125 (CA125) levels elevated to twice the upper limit of normal at baseline, divided by the total number of evaluable participants in the arm.|From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)|All participants who received study drug. n=number of evaluable participants|||Percentage of participants||95% Confidence Interval|Number
1366000|NCT01611558|Primary|Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.|Day 1, first dose, to within 90 days of last dose in Induction Phase|All participants who received at least 1 dose of study drug|||Participants|||Number
1366001|NCT01611259|Secondary|Influence of Rituximab Plus Lenalidomide on T-cell Subsets|T-cell subsets will be evaluated from EDTA blood in a central lab|Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5|||||||
1366002|NCT01611259|Secondary|Number and Severity of Adverse Events|Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population|From treatment start until 28 days after last study treatment; expected study duration 24 months|||||||
1366003|NCT01611259|Primary|Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease|The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of < 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy.|40 weeks|48 patients were included into safety assessment, two of them received treatment but no efficacy assessment was available. Therefore, these two patients were neither included into Intention-to-treat nor Per-protocol efficacy analysis.|||Participants|||Count of Participants
1366004|NCT01610791|Primary|Percentage of Participants With Adverse Events|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants who received at least one dose of study medication where at least one post-baseline assessment of safety was available.|||percentage of participants|||Number
1366005|NCT01610791|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The change in ESR was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm/hr||Standard Deviation|Mean
1366006|NCT01610791|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase inflammatory marker. Levels of CRP increase with inflammation. The change in CRP was determined as the difference in values from baseline and at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mg/dL||Standard Deviation|Mean
1366007|NCT01610791|Secondary|Patient Assessment of of Pain (VAS)|"The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no pain and the right-hand extreme of the line (100 mm) was described as unbearable pain. The change in participant's perception of pain was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm||Standard Deviation|Mean
1366008|NCT01610791|Secondary|Physician's Global Assessment of Disease Activity (VAS)|"The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity. The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician. The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm||Standard Deviation|Mean
1366009|NCT01610791|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm||Standard Deviation|Mean
1366010|NCT01610791|Secondary|Health Assessment Questionnaire (HAQ)|HAQ was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple-choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The change in HAQ was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||score on a scale||Standard Deviation|Mean
1366118|NCT01610492|Secondary|Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points|The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times.|Baseline and up to 4 week post last dose|PK Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1366011|NCT01610791|Secondary|Swollen and Tender Joint Counts|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The following 28 joints were assessed by the physician for tenderness : metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The change in SJC and TJC was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||joints||Standard Deviation|Mean
1366012|NCT01610791|Secondary|Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria|The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1366013|NCT01610791|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants with a DAS28 score <2.6 were considered to have achieved remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1366014|NCT01610791|Secondary|Time to Achieve Clinically Meaningful Reduction in DAS28|A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units. Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||days||Standard Deviation|Mean
1366015|NCT01610791|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
1366016|NCT01610791|Secondary|Percentage of Participants by DAS28 Response Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 =low disease activity, DAS28 >3.2 to ≤5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1366017|NCT01610791|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1366018|NCT01610791|Secondary|Percentage of Participants With Lipid Elevations by Study Visit|Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL. Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable <200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low <40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal <150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population; n (number) = number of participants assessed for the parameter at a given visit.|||percentage of participants|||Number
1366019|NCT01610791|Secondary|Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values|Levels of LDL and TC were measured in milligrams/deciliter (mg/dL). Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.|Baseline through Week 24|Safety population|||mg/dL||Standard Deviation|Mean
1366020|NCT01610791|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value|The difference between baseline and highest values until Week 24 of ALT and AST. The values are measures as international units per liter (UI/L). The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.|Baseline through Week 24|Safety Population|||UI/L||Standard Deviation|Mean
1366021|NCT01610791|Secondary|Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit|Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.|Weeks 4, 8, 12, 16, 20, and 24|All enrolled participants were included in the analysis|||percentage of participants|||Number
1366022|NCT01610713|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Open-label Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects that considered their condition to be better or much better at the end of open-label treatment is presented.|End of Part B (week 10)|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||participants|||Number
1366023|NCT01610713|Secondary|Change From Part A Mean Ten-metre Mobility Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 10 Metre Mobility Score is a four point scale assessing a subject’s level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates and improvement.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||time (seconds)||Standard Deviation|Mean
1366024|NCT01610713|Secondary|Change From Part A Mean Bladder Problems Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in bladder problems from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366025|NCT01610713|Secondary|Change From Part A Mean Tremor Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in tremor from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366026|NCT01610713|Secondary|Change From Part A Mean Muscle Spasm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates and improvement in spasms from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366027|NCT01610713|Secondary|Change From Part A Mean Pain Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in pain from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366028|NCT01610713|Secondary|Change From Part A Mean Spasticity Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement, as such a negative value indicates an imrovement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366029|NCT01610713|Secondary|Change From Part A Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Feeling upon wakening was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366030|NCT01610713|Secondary|Change From Part A Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366031|NCT01610713|Secondary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who recorded an adverse event during the 4 week open-label period is presented.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|This analyses set included all patients who took GW-1000-02 during the open-label treatment period.|||participants|||Number
1366131|NCT01610492|Secondary|Time to Anti-PLA2R Autoantibody Remission|Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.|Baseline and up to Week 128/6 month follow up|ITT Population|||Weeks||95% Confidence Interval|Median
1366032|NCT01610713|Secondary|Change From Mean Part A Sleep Quality 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366033|NCT01610713|Secondary|Change From Mean Part A Tremor Activities of Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366034|NCT01610713|Secondary|Change From Mean Part A Total Bladder Control Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The total bladder control test score was the sum score from fifteen questions, which were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366035|NCT01610713|Secondary|Change From Mean Part A Nine Hole Peg Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366036|NCT01610713|Secondary|Change From Mean Part A Total 28-item General Health Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366037|NCT01610713|Secondary|Change From Mean Part A Rivermead Mobility Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366038|NCT01610713|Secondary|Change From Mean Part A Fatigue Severity Scale Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366063|NCT01610700|Secondary|Change From Baseline in the Mean Fatigue Severity Scale Questionnaire Score at the End of Treatment|The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1377622|NCT01479478|Secondary|Count of Neonates With Pneumonia||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1366039|NCT01610713|Secondary|Change From Mean Part A Beck's Depression Inventory (BDI-II) Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The BDI-II was a 21-question multiple choice self-reported inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366040|NCT01610713|Secondary|Change From Mean Part A Total Adult Memory and Information Processing Battery Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366041|NCT01610713|Secondary|Change From Mean Part A Barthel Activities for Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The ability to undertake the different daily activities was assessed on scales of 0-1 to 3, with 0= poorest outcome and upper scores= best outcome. The total score was the sum of scores for each item; minimum score= 0, maximum score= 20. A change of two or greater in the total score indicating a clinically relevant change. A positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366042|NCT01610713|Secondary|Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered ‘normal’. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366043|NCT01610713|Secondary|Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366044|NCT01610713|Secondary|Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366045|NCT01610713|Secondary|Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366046|NCT01610713|Secondary|Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366047|NCT01610713|Primary|Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)|This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
1366048|NCT01610700|Secondary|Change From Baseline in the Mean Total Adult Memory and Information Processing Battery Test Score at the End of Treatment|The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366049|NCT01610700|Secondary|Change From Baseline in the Mean Guy's Neurological Disability Scale Score at the End of Treatment|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366050|NCT01610700|Secondary|Change From Baseline in the Mean Care-Giver Strain Index Score at the End of Treatment|The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366051|NCT01610700|Secondary|Change From Baseline in the Mean Reading Visual Acuity Test Score at the End of Treatment|Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366052|NCT01610700|Secondary|Change From Baseline in the Mean Short Orientation-Memory-Concentration Test at the End of Treatment|The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered ‘normal’. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366064|NCT01610700|Secondary|Change From Baseline in the Mean Beck's Depression Inventory (BDI-II) Score at the End of Treatment|This was a 21-question multiple choice self-report inventory. Subjects’ responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366053|NCT01610700|Secondary|Change From Baseline in the Mean Barthel Activities for Daily Living Scale Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The ability to undertake the 10 different daily activities was assessed on scales of 0-1, 0-2 or 0-3, with 0 indicative of the poorest outcome and the highest possible score indicative of the best outcome. The summary parameter was the total score for each of the ten items, with a minimum possible score of 0 and a maximum possible score of 20. An increased score indicates an improvement, with a change of two or greater in the total score indicating a clinically relevant change. A positive value therefore indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366054|NCT01610700|Secondary|Change From Baseline in the Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366055|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366056|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Quality 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366057|NCT01610700|Secondary|Change From Baseline in the Mean Ten-metre Mobility Score at the End of Treatment|The 10 Metre Mobility Score is a four point scale assessing a subject’s level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates an improvement in condition.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||time (seconds)||Standard Deviation|Mean
1366058|NCT01610700|Secondary|Change From Baseline in the Mean Tremor Activities of Daily Living Scale Score at the End of Treatment|The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366059|NCT01610700|Secondary|Change From Baseline in the Mean Total Bladder Control Test Score at the End of Treatment|The total bladder control test score was the sum score from fifteen questions were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient’s life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366060|NCT01610700|Secondary|Change From Baseline in the Mean Nine-hole Peg Test Score at the End of Treatment|The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366061|NCT01610700|Secondary|Change From Baseline in the Mean Total 28-item General Health Questionnaire Score at the End of Treatment|The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366062|NCT01610700|Secondary|Change From Baseline in the Mean Rivermead Mobility Index Score at the End of Treatment|The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a ‘yes’ / ‘no’ answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366065|NCT01610700|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366066|NCT01610700|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your multiple sclerosis since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their Multiple sclerosis which was used at end of treatment to aid their memory regarding their symptoms at study start. The number of subjects that considered their condition to be better or much better at the end of treatment is presented.|6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||participants|||Number
1366067|NCT01610700|Secondary|Change From Baseline in Bladder Problems Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366068|NCT01610700|Secondary|Change From Baseline in Tremor Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366069|NCT01610700|Secondary|Change From Baseline in Muscle Spasm Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366070|NCT01610700|Secondary|Change From Baseline in Pain Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366071|NCT01610700|Secondary|Change From Baseline in Spasticity Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366072|NCT01610700|Primary|Change From Baseline in Composite Primary Impairment Visual Analogue Scale Score at the End of 6 Weeks of Treatment|This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366073|NCT01610687|Secondary|Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
1366074|NCT01610687|Secondary|Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
1366075|NCT01610687|Secondary|Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
1366076|NCT01610687|Secondary|Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
1366077|NCT01610687|Secondary|Investigator Assessed Global Severity Score at Week 18|The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||participants|||Number
1366078|NCT01610687|Secondary|Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.|Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
1366079|NCT01610687|Secondary|Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment|A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.|up to 1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||sprays of study medication||Standard Deviation|Mean
1366080|NCT01610687|Primary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who experienced an adverse event during the course of this extension study is presented|up to1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||participants|||Number
1366081|NCT01610596|Secondary|Overall Disease Severity Score (Improvement)|"The proportion of subjects rated a improved for ODS at Day 8 and Day 15. Improvement is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15||||percentage of participants|||Number
1366082|NCT01610596|Secondary|Clinical Signs and Symptoms of Psoriasis|"The proportion of subjects rated a treatment success for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. Treatment success is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15|Analysis shown is based on the ITT population.|||percentage of participants|||Number
1366083|NCT01610596|Secondary|Percent Body Surface Area|Changes in percent BSA with active psoriasis in the Treatment Area|Baseline, Days 8 and 15|Analysis shown is based on the ITT population.|||Change in %BSA||Standard Deviation|Mean
1366084|NCT01610596|Primary|Overall Disease Severity Score (Success)|"Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment success at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale."|Day 15|Analysis shown is the Intent-to-treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
1366085|NCT01610570|Other Pre-specified|Number of Participants With Dose Limiting Toxicity (DLT)|Hematologic DLT was defined as any grade 4 neutropenia (<500/µL) or thrombocytopenia (<25,000/µL) refractory to platelet transfusion, any grade 2 bleeding not promptly (within 6 h of appropriate intervention) corrected with blood product support. Non-hematologic DLT's were any mithramycin-related grade ≥3 toxicity with the exception of grade 3 nausea, vomiting, or diarrhea that was controlled by symptomatic treatment within 72h, asymptomatic grade 3 elevation of serum transaminases that return to ≤grade 1 within 14 days of completing mithramycin administration, and asymptomatic electrolyte abnormalities that are correctable to grade2 or less within 48h.|Cycle 1 of therapy (or 28 days)|Hepatotoxicity|||Participants|||Count of Participants
1366086|NCT01610570|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||L||Standard Deviation|Mean
1366087|NCT01610570|Secondary|Clearance at Steady State (CLss)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||L/h||Standard Deviation|Mean
1366088|NCT01610570|Secondary|Area Under the Curve for the Dosing Interval (AUCtau)|AUCtau is AUC for the dosing interval. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||h*ng/mL||Standard Deviation|Mean
1366089|NCT01610570|Secondary|Area Under the Curve Extrapolated to Infinity (AUCinf)|AUC is a measure of the serum concentration of mithramycin over time. It is used to characterize drug absorption. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||h*ng/mL||Standard Deviation|Mean
1366090|NCT01610570|Secondary|Half-Life (HL) of Mithramycin|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||hours||Standard Deviation|Mean
1366091|NCT01610570|Secondary|Maximum Plasma Concentration (Cmax) of Mithramycin Using Non-Compartmental Methods|The maximum observed analyte concentration in serum was reported. Mithramycin plasma concentrations were measured using high-performance liquid chromatography tandem mass spectroscopic method, and analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||ng/mL||Standard Deviation|Mean
1366092|NCT01610570|Secondary|Number of Participants With a Change in Tumor Burden Measured by the World Health Organization (WHO) Criteria|Per the WHO criteria, progressive disease is a 25% increase in tumor lesions, or the appearance of any new measureable or non-measureable tumor lesions. Partial response is ≥50% decrease in tumor lesions. Complete response is disappearance of all tumor lesions. Stable disease is 50% decrease in tumor lesions compared to baseline, nor 25% increase compared with nadir.|≥4 weeks from baseline|Changes in tumor burden was not evaluated for patients on the phase I portion of the study (patients 4 and 6). Changes in tumor burden was evaluated on the phase II portion of the study only for patients 1, 2, 3, 5, 7, and 8.|||Participants|||Count of Participants
1366093|NCT01610570|Secondary|Number of Participants With a Change in Tumor Burden Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)|Measurable disease were to be quantified using volumetric magnetic resonance imaging analysis per the RECIST, measuring soft tissue disease. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|≥4 weeks from baseline|Changes in tumor burden was not evaluated for patients on the phase I portion of the study (patients 4 and 6). Changes in tumor burden was evaluated on the phase II portion of the study only for patients 1, 2, 3, 5, 7, and 8.|||Participants|||Count of Participants
1366094|NCT01610570|Secondary|Count of Participants With NR0B1 Expression in Tumor Biopsies|Biopsies were to be obtained in adult patients who have disease that could be safely biopsied.|Pre-treatment and day 4 (+/- 1 day)|This outcome measure was not done because none of the adult patients on this study had disease that was deemed accessible.||||||
1366095|NCT01610570|Secondary|Time to Progression (TTP)|TTP is defined as the number of days from enrollment until disease progression, death because of treatment complications, resection of measureable tumor, or last patient follow-up, whichever comes first, assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|At date of progression, an average of 56 days|TTP was not evaluated for patients on the phase I portion of the study (patients 4 and 6). TTP was evaluated on the phase II portion of the study only for patients 1, 2, 3, 5, 7, and 8.|||Days|||Number
1366096|NCT01610570|Secondary|Objective Response Rate (Complete Response (CR) + Partial Response (PR))|Objective response in children and adolescents with Ewings sarcoma - friend leukemia integration 1 transcription factor to mithramycin is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions.|1-2 months|This is a phase II objective, thus phase I groups are not shown here.|||participants|||Number
1366097|NCT01610570|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of serious and non-serious adverse events see the adverse event module.|95 days||||Participants|||Count of Participants
1377623|NCT01479478|Secondary|Count of Neonates With Sepsis||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1366098|NCT01610570|Primary|Maximum Tolerated Dose (MTD) of Mithramycin|The MTD will be the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicity (DLT) (i.e., non-hematologic toxicity and hematologic toxicity) during cycle 1 (or 28 days) of therapy.|Cycle 1 of therapy (or 28 days)|MTD was not determined because based on pharmacokinetic data, a clinically relevant dose could not be obtained with the dose strategy. A minimum of 3 patients must be enrolled on a dose level to complete that dose level. Because only 2 patients were enrolled on phase I portion of the trial, dose level 1 was not completed and an MTD was not reached.||||||
1366099|NCT01610557|Secondary|Change in Central Retinal Thickness Assessed by Optical Coherence Tomography (OCT) Central Subfield Mean Thickness (CSMT) From Baseline to 36 Weeks (Crossover Phase of the Study)|Optical Coherence Tomography (OCT) scans were graded in masked fashion by Duke University Reading Center (Durham, North Carolina). Per the initial protocol specifications, OCT scans were to be performed on a Cirrus OCT machine; however, some scans were performed on a Spectralis OCT machine at one of the sites due to technical difficulties. The protocol was amended to allow for Cirrus and Spectralis OCT scans at subsequent visits at the affected site. Spectralis values were then converted to Cirrus central subfield mean thickness (CSMT) values through a validated linear conversion function.|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.|||micrometers|Participants|95% Confidence Interval|Mean
1366100|NCT01610557|Primary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to 36 Weeks (Crossover Phase of the Study)|"The primary outcome for 3-months change in BCVA utilized data from Weeks 12, 24 and 36 aggregated in a linear mixed-effects model. This model included adjustments accounting for period (i.e., Weeks 12, 24 and 36), treatment in current period, treatment in prior period, and baseline BCVA to provide the estimated 3-month BCVA change.~Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.|||ETDRS letters|Participants|95% Confidence Interval|Mean
1366101|NCT01610492|Secondary|Urine BLys Levels as a Ratio to Creatinine|B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS: creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. Only raw BLyS values available and unable to be assessed due to lack of comparison to a creatinine as a urine concentration marker.|Baseline and Week 116/16 week follow-up visit|ITT Population||||||
1366102|NCT01610492|Secondary|Serum BLys Levels|Free BLyS protein were analyzed using an ELISA. Serum samples were collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit.|Baseline and Week 116/16 week follow-up visit|ITT Population|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1366103|NCT01610492|Secondary|Change From Baseline in Cytokines/Chemokine|Cytokine/chemokine associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification were used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Endpoint was moved to ‘Exploratory’ in Protocol amendment 5 as benefits of assessing cytokines was deemed low. Samples were not analyzed.|Baseline and up to Week 104/4 week post last dose|ITT Population||||||
1366104|NCT01610492|Secondary|Change From Baseline in B Cell and T Cell Markers Concentration|B cell Facs panels were used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel were used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 128/6 month post last dose|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1366105|NCT01610492|Secondary|Change From Baseline in Urine Membrane Attack Complex (MAC)|Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). Endpoint was changed to 'exploratory' as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed.|Baseline and up to 4 week post last dose|ITT Population||||||
1366106|NCT01610492|Secondary|Urine Membrane Attack Complex (MAC) Levels|Urine membrane attack complex was assayed quantitatively by ELISA method. Urine MAC samples were collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results were normalized using urine creatinine concentration to adjust for urine dilution. Endpoint was moved to ‘Exploratory’ in Protocol amendment 5 as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed|Baseline and up to 4 week post last dose|ITT Population||||||
1366107|NCT01610492|Secondary|Number of Participants With Positive Immunogenicity Findings|Blood samples of participants were collected pre-dose on Weeks 0, 12, 28, 40, 52, 76, 4 week post last dose and 16 week post last dose visit for belimumab immunogenicity assay. No participants showed positive immunogenicity findings.|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Participants|||Number
1366108|NCT01610492|Secondary|Change From Baseline in Temperature|Temperature was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Celsius||Standard Deviation|Mean
1366109|NCT01610492|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Beats per minute||Standard Deviation|Mean
1366110|NCT01610492|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week follow-up visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to week 116/16 week follow-up visit|ITT Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1366111|NCT01610492|Secondary|Number of Participants With Urinalysis Dipstick Findings|Urine samples were collected for urinalysis by dipstick method from Baseline up to Week 116/16 months follow up and number of participants with findings were presented for Baseline, Week 12, 28, 52, 76, 104/4 weeks post last-dose and Week 116/16 week follow up (WF). The urinalysis parameters included occult blood, glucose, ketones, protein. The findings were presented as trace or 1/10 g/100 milliliter (dL), trace, negative, 4+, 3+, 3+ or 1 g/dL, 2+ or 1/2 g/dL, 2+, 1+ or 1/4 g/dL and 1+. Only participants present at the specific time points were presented (represented by n=X in the category titles).|Baseline and up to Week 116/16 Week follow up|ITT Population|||Participants|||Number
1366112|NCT01610492|Secondary|Number of Participants With Abnormal Clinical Chemistry and Hematology Values|Blood samples were collected from participants for evaluation of clinical chemistry and hematology parameters. The clinical chemistry parameters included albumin, alkaline phosphatase (alk.phosph.), alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin, calcium, cholesterol, chloride, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, lactate dehydrogenase (LD), magnesium, sodium, phosphorus, total protein, blood urea nitrogen (BUN) and uric acid. The hematology parameters included basophils, eosinophil, hemoglobin, hematocrit, lymphocytes, monocytes, total neutrophils, platelets, red blood cells (RBC) count and white blood cells (WBC) count. Participants were counted in the category that their value changes to (low or high) for the specific time points. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Participants|||Number
1366113|NCT01610492|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, is a congenital anomaly/birth defect, may require medical or surgical intervention, is associated with liver injury and impaired liver function.|Baseline and up to Week 128/6 month follow up|ITT Population|||Participants|||Number
1366114|NCT01610492|Secondary|Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score|Health-related quality of life was assessed through participant self-completion of the short form health survey (SF-36 version [v2]), a general health related quality of life metrics. Norm-based Scores (NBS) for physical functioning, role emotional, role physical were assessed. The remaining SF-36 component scores require re-scaling and therefore will be added at a later date. SF-36 was administered prior to any procedures at Weeks 12, 28, 52, 76 and 104/4 week post last dose. Item score were recorded and higher score represented better health status. Baseline is defined as Day 0 pre dose value and change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and up to Week 104/4 week post last dose|ITT Population|||Scores on a scale||Standard Deviation|Mean
1366115|NCT01610492|Secondary|Summary of Total Amount of Urine Excreted Ae(0-24)|PK parameters from the urine concentration data: urine Ae(0-24) were assessed. 24 h urine collections for PK analysis were collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach was undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis was conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. Several samples were taken pre-dose at Day 0 and some at week 12 incorrectly which affects interpretation.|Baseline and Up to 4 week post last dose|PK Population|||ng/hour||Standard Deviation|Mean
1366116|NCT01610492|Secondary|Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2])|The AUC(0-2) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis were collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results will be posted at later date following post hoc analysis.|Baseline and up to 4 week post last dose|PK Population||||||
1366117|NCT01610492|Secondary|Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points|Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose.|Baseline and up to 4 week post last dose|PK Population|||ng/mL||Standard Deviation|Mean
1368625|NCT01584479|Primary|Percentage of Participants With Tooth Loss Over 16 Year Period|Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.|16 years||||percentage of participants|||Number
1366119|NCT01610492|Secondary|Number of Participants With Edema and Edema Extending Beyond Calf|Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, and 104|ITT Population|||Participants|||Number
1366120|NCT01610492|Secondary|Change From Baseline in Serum IgG at the Indicated Time Points|Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up|ITT Population|||Ratio||Standard Deviation|Mean
1366121|NCT01610492|Secondary|Serum Immunoglobulin G (IgG) Levels at Indicated Time Points|Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||g/L||Standard Deviation|Mean
1366122|NCT01610492|Secondary|Change From Baseline in Serum Cholesterol at the Indicated Time Points|Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
1366123|NCT01610492|Secondary|Serum Cholesterol Levels at Indicated Time Points|Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||millimoles per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
1366124|NCT01610492|Secondary|Change From Baseline in Levels of Serum Albumin at the Indicated Time Points|Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||ratio||Geometric Coefficient of Variation|Geometric Mean
1366125|NCT01610492|Secondary|Serum Albumin Levels at Indicated Time Points|Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.|ITT Population|||grams per liter (g/L)||Geometric Coefficient of Variation|Geometric Mean
1366126|NCT01610492|Secondary|Change From Baseline in Serum Creatinine Levels at the Indicated Time Points|Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1366127|NCT01610492|Secondary|Serum Creatinine Levels at the Indicated Time Points|Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||micromoles/liter (µmol/L)||Geometric Coefficient of Variation|Geometric Mean
1366128|NCT01610492|Secondary|Change From Baseline in eGFR Levels at the Indicated Time Points|eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 128/6 month follow up|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1366129|NCT01610492|Secondary|eGFR Levels at the Indicated Time Points|eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.|ITT Population|||milliliter/minute (mL/min/1.73meter^2)||Geometric Coefficient of Variation|Geometric Mean
1366130|NCT01610492|Secondary|Number of Participants With Anti-PLA2R Autoantibody Relapse|Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and up to Week 128/6 month follow up|ITT Population|||Participants|||Number
1368626|NCT01584388|Secondary|Time to Complete Remission|Treatment phase up to 52 weeks (365 days)|Days||||Days||Standard Deviation|Mean
1366132|NCT01610492|Secondary|Number of Participants With PLA2R Autoantibody Remission|Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128|ITT Population|||Participants|||Number
1366133|NCT01610492|Secondary|Duration of Complete or Partial Remission|Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.|Baseline and up to Week 128/6 month follow up|ITT Population|||Days||Standard Deviation|Mean
1366134|NCT01610492|Secondary|Time to Complete or Partial Remission|Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15 percent ). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed.|Baseline and up to Week 128/6 month follow up|ITT Population|||Weeks||95% Confidence Interval|Median
1366135|NCT01610492|Secondary|Number of Participants With Complete or Partial Remission|Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3grams [g]/24 h) with no worsening in renal function (estimated glomerular filtration rate [eGFR] reduction from Baseline <15 percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128|ITT Population|||Participants|||Number
1366136|NCT01610492|Secondary|Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points|Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128.|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1366137|NCT01610492|Secondary|Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points|Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population.|||relative units per milliliter (RU/mL)||Geometric Coefficient of Variation|Geometric Mean
1366138|NCT01610492|Secondary|Change From Baseline in Proteinuria Levels at the Indicated Time Points|Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up|ITT Population.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1366139|NCT01610492|Secondary|Proteinuria Levels at the Indicated Time Points|Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||milligrams per millimole (mg/mmol)||Geometric Coefficient of Variation|Geometric Mean
1366140|NCT01610492|Primary|Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28|PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.|Baseline and Week 28|ITT Population. Only those participants available at the indicated time point (Week 28) were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1366141|NCT01610492|Primary|Change From Baseline in Proteinuria Levels at Week 28|Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.|Baseline and Week 28|Intent-to-Treat (ITT) Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1366142|NCT01610453|Secondary|Percentage of Women With Cesarean Section|The percentage of women with cesarean section was compared in cases with occiput posterior position and cases with non occiput posterior position assessed with transabdominal sonography when prolonged labor was diagnosed.|active labor|Fetal head position was assessed successfully using transabdominal ultrasound in 142/150 women. Position could not be diagnosed in eight cases due to shadowing from maternal pelvis in cases at low stations.|||percentage of participants in each group|||Number
1366143|NCT01610453|Primary|Percentage of Women With Vaginal Deliveries|Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance (HPD) ≤40 mm and angle of progression (AoP) ≥110 degrees were used as cut-off level. HPD was obtained in all 150 cases and AoP was successfully obtained in 145 cases.|active labor|AoP could not be measured in 5 cases because only a part of the symphysis was visualized.|||percentage of participants in each group||95% Confidence Interval|Number
1366144|NCT01610414|Secondary|Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.|From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)|The analysis was performed on the Total Enrolled Cohort.|||Participants|||Count of Participants
1366145|NCT01610414|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This enpoint also presents SAES related to the GSK study vaccine/placebo.|From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
1366146|NCT01610414|Secondary|Number of Subjects With Any Relapse|Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.|From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
1366147|NCT01610414|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Month 0 up to 365 days post last vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
1366148|NCT01610414|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
1366149|NCT01610414|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets.|||Participants|||Count of Participants
1366150|NCT01610414|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets.|||Participants|||Count of Participants
1366151|NCT01610414|Secondary|Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects|Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL.|At Months 0, 1, 2, 13 and 25|The analysis was performed on the adapted According-to-Protocol (ATP) cohort for humoral immunogenicity, which included data from the ATP cohorts for humoral immunogenicity at Months 0,1,2,13 and 25. The ATP cohort for humoral immunogenicity included all subjects from humoral immunogenicity sub-cohort in ATP cohort for analysis of immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
1366240|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1366152|NCT01610414|Secondary|Number of Subjects With Postherpetic Neuralgia (PHN)|This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.|From Month 0 until study end (21 months median follow-up)|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1366153|NCT01610414|Secondary|Number of Subjects With Confirmed HZ-associated Complications|This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.|From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1366154|NCT01610414|Secondary|Duration of ‘Worst’ HZ-associated Pain|Duration of HZ-associated pain rated as 3 or greater on the ‘worst pain’ Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) [=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days].|From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis, who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||T (day)|||Number
1366155|NCT01610414|Primary|Number of Subjects With Confirmed Herpes Zoster (HZ) Episode|"A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings* suggestive of VZV infection in the absence of characteristic HZ or VZV rash.~A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise."|From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1366156|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Cardiac Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Cardiac MRI values between 10 to 20 milliseconds (ms) are indicative of moderate cardiac iron deposition associated with declining left ventricular ejection fraction and arrhythmias while values <10 ms are indicative of deposition sufficient to risk cardiac decompensation and associated with overt heart failure and mortality.|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||ms||Standard Deviation|Mean
1366157|NCT01610297|Secondary|The Percentage of Patients Reaching Serum Ferritin Levels Lower Than 500 μg/L|Serum Ferritin values between 1000-2500 μg/L are indicative of mild to moderate iron overload while values >2500 μg/L are indicative of severe iron overload and levels constantly higher than 2500 μg/L has been shown to to increase the risk of cardiac complications and endocrine disease. Maintaining levels <1000 μg/L is associated with increased survival and less morbidity.|Week 28 and Week 52|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||Percentage of Patients|||Number
1366158|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Liver Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Liver Iron Concentration (LIC) values between 3 and 7 mg Fe / g dry weight are indicative of mild iron deposition, while values between 7 and 15 mg Fe / g dry weight are indicative of moderate iron deposition which have been associated with liver disease. Values >15 mg Fe/g dry weight are indicative of severe iron deposition which is associated with progressive liver fibrosis, increased morbidity and mortality|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||mg Fe/g dry liver weight||Standard Deviation|Mean
1366159|NCT01610297|Secondary|Change in Serum Ferritin Level.|Blood samples were collected and serum levels were assessed at study baseline (BL) and at 12 months.|Baseline, 12 Months|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||ng/mL||Standard Deviation|Mean
1366160|NCT01610297|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths as a Measure of Safety and Tolerability|To determine the safety; incidence, type and severity of adverse events including renal, hepatic, biochemistry and hematologic parameters of deferasirox in the treatment of iron overload after hematopoietic stem cell transplantation (HSCT) in patients with beta-thalassemia major in 12 months period|12 months|The Safety Set (SS) includes all included patients who were included in the study. All statistical analyses of safety and tolerability will be done in the SS.|||Participants|||Number
1366161|NCT01610167|Secondary|Extended Sensitivity Relief. Air Blast Sensitivity.|Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.|28 days (+/- 2 days) post treatment.||||units on a scale||Standard Deviation|Mean
1366162|NCT01610167|Primary|Immediate Sensitivity Relief. Air Blast Sensitivity.|Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.|Immediately after treatment.||||units on a scale||Standard Deviation|Mean
1366358|NCT01607853|Secondary|Change From Baseline in Erythema at Day 11|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11||||units on a scale||Standard Deviation|Mean
1366163|NCT01610167|Secondary|Extended Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination."|28 days (+/- 2 days) post treatment.|Intent to treat (ITT).|||grams||Standard Deviation|Mean
1366164|NCT01610167|Primary|Adverse Events.|Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).|Immediately after treatment to 28 days (+/- 2 days) post treatment.|Intent to treat (ITT).|||Number of adverse events.|||Number
1366165|NCT01610167|Primary|Immediate Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment."|Immediately after treatment.|Intention to treat (ITT).|||grams||Standard Deviation|Mean
1366166|NCT01610154|Secondary|Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI|The glucagon-AUC was adopted to show pancreatic α cell function.|Baseline to 12 weeks||||min∙pg/ml||Standard Deviation|Mean
1366167|NCT01610154|Secondary|Change From Baseline in Pancreatic α Cell Function|The glucagon-AUC was adopted to show pancreatic α cell function.|Baseline to 12 weeks||||min∙pg/ml||Standard Deviation|Mean
1366168|NCT01610154|Secondary|Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI|The early phase insulin response (△I30/△G30) was adopted to determine β cell function.|Baseline to 12 weeks||||μu/ml/mmol||Inter-Quartile Range|Median
1366169|NCT01610154|Secondary|Change From Baseline in Pancreatic β Cell Function|The early phase insulin response (△I30/△G30) was adopted to determine β cell function.|Baseline to 12 weeks||||μu/ml/mmol||Inter-Quartile Range|Median
1366170|NCT01610154|Secondary|Change From Baseline in Insulin Sensitivity in Patients With Different BMI|The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.|Baseline to 12 weeks||||mg/kg/min||Inter-Quartile Range|Median
1366171|NCT01610154|Secondary|Change From Baseline in Insulin Sensitivity|The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.|Baseline to 12 weeks||||mg/kg/min||Inter-Quartile Range|Median
1366172|NCT01610154|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG)||Baseline to 12 weeks||||mmol/L||Standard Deviation|Mean
1366173|NCT01610154|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)||Baseline to 12 weeks||||mmol/L||Standard Deviation|Mean
1366174|NCT01610154|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)||Baseline to 12 weeks||||percentage||Standard Deviation|Mean
1366175|NCT01610076|Secondary|Willingness to Recommend Video to Other Patients|"Participants were surveyed, Would you recommend this video to other patients? Three options were provided:~Definitely recommend Probably recommend Do not recommend"|immediately after intervention||||participants|||Number
1366176|NCT01610076|Secondary|Perception of Utility of Video|"Participants were surveyed, How helpful was this video in helping you understand your options? There possible answers were provided:~Very helpful Somewhat helpful Not helpful"|immediately after intervention||||participants|||Number
1366177|NCT01610076|Secondary|Participant Reported Comfort With Video Intervention|"Patient's were surveyed about How comfortable were you watching the video?"|immediately after intervention|Patient's surveyed about|||participants|||Number
1366178|NCT01610076|Primary|12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)|"12 question (question 4 has 4 sub-questions) survey previously validated to determine knowledge level about resuscitation status with total score on the scale of 0-15. Possible scores ranged from 0 to 15, with higher scores representing increased medical knowledge.~The CPR knowledge survey assesses a participants basic understanding of cardiopulmonary resuscitation (CPR). The survey consisted of 12 questions with one point being awarded for each correct response. Question four had a total of four possible correct answers. Thus the scores on the scale of 0-15 points is designed, with higher scores representing increased knowledge."|after admission to ICU, approx one hour||||points||Inter-Quartile Range|Median
1366179|NCT01610063|Secondary|Remitters at Week 8|Definitions of the depression questionnaires are found in previous outcome measures. Definition of remitter: a participant with score less than or equal to certain value (HAMD-17 <=7, QIDS-C16<=5, PHQ-9<5).|baseline, 8 weeks||||percentage of participants|||Number
1366180|NCT01610063|Secondary|Responders at Week 8|Definitions of the depression questionnaires are found in previous outcome measures. Definition of responder: a participant who had 50% or higher reduction in psychiatric score from baseline.|baseline, 8 weeks||||percentage of participants|||Number
1366181|NCT01610063|Secondary|Physicians' Perception of Participant's Satisfaction With Their Care|Physicians reported on their perception of each participant’s satisfaction with their care only for patients who completed the 8-week study. Physicians were directed to complete a survey for each participant detaining their experience during the study period.|8-week visit|Physicians completed surveys for 89 participants (96%) from the unguided group, and for 37 participants (51.4%) from the guided group. For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms. For the first row, one of the physicians who completed the survey did not answer this question.|||percentage of physicians|||Number
1366182|NCT01610063|Secondary|Pharmacogenomic Report Utilization|Physicians were directed to complete a survey for each participant detailing their experiences during the study period.|baseline, 8-week visit|The medication changes of patients were recorded only for patients who completed the 8-week study (n=72,93 for guided and unguided arms). For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms.|||percentage of participants|||Number
1366241|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
1368627|NCT01584388|Secondary|Time to Relapse|Treatment phase up to 52 weeks (365 days)|Days||||Days||Standard Deviation|Mean
1366183|NCT01610063|Secondary|Percentage Change in Outcome by Bin Status and Treatment Group|"The Genesight algorithm presents recommendations for antidepressants and antipsychotics in bin status associated with colors. Green indicates Use as Directed. Yellow indicates Use with Caution. Red indicates Use with Increased Caution and with More Frequent Monitoring. Definitions of the depression questionnaires are found in previous outcome measures. A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms."|baseline, 8-week visit|All subjects were evaluated for a bin status, but not all the arms had subjects assigned to every bin status (green, yellow, or red). Bin status for each category title is reported as (n=Guided, Unguided).|||Percentage change||Standard Deviation|Mean
1366184|NCT01610063|Secondary|Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline|The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. A negative change indicates improvement in the subject's depression symptoms, and a positive change indicates a worsening of the subject's depression symptoms.|baseline, 8-week visit|There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided). One subject in the guided arm (green/yellow) did not complete the PHQ-9 questionnaire at 8 weeks.|||Percentage change in depression rating||Standard Deviation|Mean
1366185|NCT01610063|Secondary|Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline|The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.|baseline, 8-week visit|This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided).|||Percentage change in depression rating||Standard Deviation|Mean
1366186|NCT01610063|Primary|Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline|The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.|baseline, 8-week visit|This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided).|||Percentage change in depression rating||Standard Deviation|Mean
1366187|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Liters||Standard Deviation|Mean
1366188|NCT01610037|Secondary|Time to Premature Discontinuation|Time to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment early. The range of the ‘time to treatment discontinuation’ varied from 5-407 days in the Tiotropium group. Hence the model estimated lower limit of the median time to treatment discontinuation is greater than the scheduled treatment period of 52 weeks.|Time varied from 5 - 407 days|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
1366189|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Liters||Standard Deviation|Mean
1366190|NCT01610037|Secondary|Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.|A day able to perform usual daily activities’ is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Percentage of days||Standard Deviation|Mean
1366191|NCT01610037|Secondary|Change From Baseline in Percentage of no Daytime Symptoms|A day with ‘no daytime symptoms’ is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx. 8 am to 8 pm).|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Percentage of days||Standard Deviation|Mean
1366192|NCT01610037|Secondary|Change From Baseline in Percentage of Nights With ‘no Nighttime Awakenings|A night with ‘no nighttime awakenings’ is defined from diary data as any night where the patient did not wake up due to symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Percentage of nights||Standard Deviation|Mean
1366193|NCT01610037|Secondary|Change From Baseline in Daily, Morning and Evening Symptom Scores|Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease. The mean daily total symptom score, the mean daytime total symptom score and the mean nighttime total symptom score were calculated for each patient over 52 weeks. Diary data recorded during the 14 day run-in period were used to calculate the baseline.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Score||Standard Deviation|Mean
1366194|NCT01610037|Secondary|Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)|"The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score will be calculated for each of these three subscales and a Total score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|Measurment at day 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Score||Standard Deviation|Mean
1366195|NCT01610037|Secondary|Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|Day 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who eceived at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Liters||Standard Error|Least Squares Mean
1366196|NCT01610037|Secondary|Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE|The composite endpoint included all deaths and all serious CCV events, including MACE and events which were not considered MACE. A rigorous post hoc analysis was done on composite endpoint of CV deaths and major adverse cardiovascular events (MACE). The patients with an event in the analysis were those who had at least one of the 2 events namely, CV deaths and MACE, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.|||Percentage of participants|||Number
1366197|NCT01610037|Secondary|Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.|The endpoint of all-cause mortality and serious CCV events (composite) was chosen to further characterize any discernible risks. The patients with an event in the analysis were those who had at least one of the 2 events namely, all-cause mortality and serious CCV, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.|||Percentage of participants|||Number
1366198|NCT01610037|Primary|Number of Patients With Serious Adverse Events|The overall rate of serious adverse events reported from initiation through 30 days post last dose.|Week 52|The safety set included all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. A patient who had no adverse events also constitutes a safety assessment.|||Participants|||Number
1366199|NCT01610011|Primary|Brain Glycine Increments After Oral Glycine Administration Measured With MRS as Glycine/Total Creatine, Normalized to the Glycine Dose Administered (g/kg).|Brain and plasma glycine levels are measured with proton magnetic resonance spectroscopy at 4T and analytically, respectively. Because glycine doses were limited to 30 g to avoid nausea and vomiting, some subjects with higher weights were administered lower doses per body weight of glycine (g/kg). Therefore, we corrected MRS data by the actual glycine dose administered (g/kg) to account for dosing differences.|For up to 2 hours|Subjects completing the magnetic resonance spectroscopy study.|||Percent brain glycine/creatine increase|Participants|Standard Error|Mean
1366237|NCT01609348|Primary|Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.|"Treatment will be considered efficacious if the proportion of worse categories (including 'minimal worsening', 'moderate worsening', or 'marked worsening') is lower under treatment than control on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change.~Clinical Global Impression of Change: This is a 7-item score ranging from “markedly worse” to “markedly improved”. It is assessed by the study clinician who interviews both participant and informant and makes an informed judgment how to incorporate their input"|12 weeks||||Participants|||Count of Participants
1366200|NCT01609933|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after initiation of study drug through 30 days post-DAA dosing. For more details on AEs, see the AE section.|From first dose of study drug through 30 days after last dose of study drug (DAAs plus pegIFN alpha-2a and RBV) (up to 28 weeks).|Safety population (all subjects who received at least 1 dose of study drug)|||participants|||Number
1366201|NCT01609933|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ|Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1366202|NCT01609933|Secondary|Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24)|SVR24 was defined as HCV RNA level less than the LLOQ 24 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).|24 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 48 weeks after subject’s initial dose of study drug in Substudy 1|ITT population|||percentage of participants||95% Confidence Interval|Number
1366203|NCT01609933|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation [LLOQ] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).|12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject’s initial dose of study drug in Substudy 1|ITT population|||percentage of participants||95% Confidence Interval|Number
1366204|NCT01609790|Other Pre-specified|Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2)|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|From randomization to date of death or last followup. Statistical analysis occurs when tumor genotype, expression profile and circulating angiogenesis biomarkers have been determined from the tissue specimens.|||||||
1366205|NCT01609790|Secondary|Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)|Feasibility of trebananib weekly in combination with bevacizumab every 2 weeks, measured by the percentage of patients requiring dose reduction/interruption or discontinuation in the first 2 and subsequent courses (Cohort 1)|From randomization up to 3 years.|Eligible patients|||Participants|||Count of Participants
1366206|NCT01609790|Secondary|Radiographic Response Rate (Cohort 2)|Proportion of patients with best overall response of complete response (CR) or partial response (PR) recorded from the start of the treatment until disease progression/recurrence. Response determined by site-reported radiology review of MRI exams using Response Assessment in Neuro-Oncology Criteria (RANO) criteria. CR: Complete disappearance of all enhancing measurable disease (MD) + non-measurable disease (NMD) sustained >= 4 wks; No new lesions; Stable or improved non-enhancing (T2/FLAIR) lesions; Off corticosteroids (or on physiologic replacement doses only); Stable/improved clinically. PR: >= 50% decrease vs. baseline of sum of products of perpendicular diameters of all measurable enhancing lesions sustained >= 4 wks; No progression of NMD; No new lesions; Stable/improved non-enhancing (T2/FLAIR) lesions on <= dose of corticosteroids vs. baseline scan; Corticosteroid dose at evaluation scan <= baseline scan dose; Stable or improved clinically. NMD only cannot be a CR or PR.|From randomization up to 3 years.|All randomized and eligible patients.|||percentage of participants||95% Confidence Interval|Number
1366207|NCT01609790|Secondary|Progression-free Survival (Cohort 2)|Progression-free survival time is measured from randomization to the date of first progression or death or, otherwise, the last follow-up date on which the patient was reported alive. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|From randomization up to 3 years.|All randomized and eligible patients.|||percentage of participants||95% Confidence Interval|Number
1366208|NCT01609790|Secondary|Overall Survival (Cohort 2)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|From randomization up to 3 years.|All randomized and eligible patients.|||Months||95% Confidence Interval|Median
1366209|NCT01609790|Secondary|Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2)|Adverse events (AEs) are graded by using CTCAE 4.0. Possibly/probably/definitely related to protocol treatment AEs are considered.|From start of treatment up to 3 years.|Randomized and eligible patients who started protocol treatment.|||participants|||Number
1366210|NCT01609790|Primary|Six-month Progression-free Survival (Cohort 2)|As determined by central review of MRI exams, assessed using RANO criteria for progression that is defined by any of the following: > 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease.|From randomization to six months.|Randomized patients evaluable for 6 months progression-free survival (PFS).|||percentage of participants||95% Confidence Interval|Number
1366242|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
1366211|NCT01609790|Primary|Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1)|Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, wound dehiscence, or reversible posterior leukoencephalopathy of any grade; Delay of treatment > 28 days. If 2+ of patients experience a DLT among 6 eligible patients, this drug combination will be considered unsafe and a lower dose of AMG will be explored; otherwise conclude that this drug combination is safe. The probability of claiming safe dose is no more than 16% when the true DLT rate is >45%, and the probability of claiming safe dose is at least 78% when the true DLT rate is <= 15%.|From start of treatment to 4 weeks.|All eligible patients who started study treatment|||participants|||Number
1366212|NCT01609582|Secondary|Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke.|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.|||days||95% Confidence Interval|Median
1366213|NCT01609582|Primary|Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.|||days||95% Confidence Interval|Median
1366214|NCT01609543|Secondary|Percentage of Participants Who Were Alive at 1 Year||1 Year (12 months)|ITT population. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.|||Percentage of Participants|||Number
1366215|NCT01609543|Secondary|Percentage of Participants With Best Overall Response (BOR)|BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to progressive disease or death (up to 34 months)|ITT population.|||Percentage of Participants|||Number
1366216|NCT01609543|Primary|Progression-Free Survival (PFS)|PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.|Baseline to progressive disease or death (up to 34 months)|ITT population.|||Months||95% Confidence Interval|Median
1366217|NCT01609478|Secondary|Plasma Indacaterol Concentrations at Day 1 and Day 14|Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup|Day 1 and Day 14|Pharmacokinetic (PK) profiling subgroup included all randomized patients who consented to participate in the additional PK assessment.|||pg/ml||Standard Deviation|Mean
1366218|NCT01609478|Secondary|Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period|Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||milligrams (mg)||Standard Deviation|Mean
1366219|NCT01609478|Secondary|The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period|The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||percentage of participants|||Number
1366243|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GI.1 VLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1366220|NCT01609478|Secondary|Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period|Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||days||95% Confidence Interval|Median
1366221|NCT01609478|Secondary|The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||percentage of participants|||Number
1366222|NCT01609478|Secondary|Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||days||Standard Deviation|Mean
1366223|NCT01609478|Secondary|The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||# of exacerbations||95% Confidence Interval|Number
1366224|NCT01609478|Secondary|Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||weeks||95% Confidence Interval|Median
1366225|NCT01609478|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|4 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1366226|NCT01609478|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment|Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||number of puffs||Standard Deviation|Least Squares Mean
1366227|NCT01609478|Secondary|Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.|PEFR is measured with portable spirometer by participants every morning and evening at home.|baseline, 4weeks, 8 weeks and 12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters/second||Standard Error|Least Squares Mean
1368628|NCT01584388|Secondary|Time to Disease Response|Treatment phase up to 52 weeks (365 days)|Mean days +/- standard deviation||||Days||Standard Deviation|Mean
1366228|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|after 4 weeks (Day 29) and after 8 weeks (Day 57)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||units on a scale||Standard Error|Least Squares Mean
1366229|NCT01609478|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)|Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.|Day 1, 2 weeks (Day 14), 12 weeks (Day 84)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters||Standard Error|Least Squares Mean
1366230|NCT01609478|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)|Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.|Day 1, 2 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Liters||Standard Error|Least Squares Mean
1366231|NCT01609478|Secondary|Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters/second||Standard Error|Least Squares Mean
1366232|NCT01609478|Secondary|Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||ratio||Standard Error|Least Squares Mean
1366233|NCT01609478|Secondary|Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points|Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters||Standard Error|Least Squares Mean
1366234|NCT01609478|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.|Day 15, Day 29 and Day 57|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Liters||Standard Error|Least Squares Mean
1366235|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)|The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|aftert 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1366236|NCT01609478|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)|after 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Liters||Standard Error|Least Squares Mean
1366238|NCT01609257|Secondary|Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)|Unsolicited AEs indicates any and all AEs that occurred other than those that were solicited.|Vaccination Stage: Initial vaccination until 28 days after second vaccination; or Challenge Stage: the day of challenge until 60 days after challenge|MITT population included all participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1366244|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMFR From Baseline|HBGA (PGM) is Histoblood Group Antigen (Pig Gastric Mucin).|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
1366245|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
1366246|NCT01609257|Secondary|Percentage of Participant With ELISA IgA- Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1366247|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
1366248|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
1366249|NCT01609257|Secondary|Percentage of Participants With ELISA IgA- Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1366250|NCT01609257|Secondary|ELISA Immunoglobulin A (IgA)- Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
1366251|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
1366252|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1366253|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
1366254|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
1366255|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1366256|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
1366257|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HGBA Antibodies Prior to Challenge Associated With Protection From GII.4 Infection|Percentage of placebo subjects HBGA seropositive pre-challenge by infection status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants|||Number
1366258|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HBGA Antibodies Prior to Challenge Associated With Protection From GII.4 Illness|Percentage of placebo subjects HBGA seropositive pre-challenge by illness status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants|||Number
1366259|NCT01609257|Secondary|Percentage of Participants With GII.4 Seroresponse Rate (4-fold Rise) From Pre-challenge Day 0 to Post-Challenge Day 30|Seroresponse was a 4-fold increase in IgG ELISA anti-GII.4 norovirus P particle antibody titer from pre-challenge to post-challenge.|Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
1366260|NCT01609257|Secondary|Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase||Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants with at least one dose of study drug, challenge stage with data available for analysis.|||percentage of participants|||Number
1366261|NCT01609257|Secondary|Duration of Viral AGE Due to GII.4 Strain During the Inpatient Phase|Duration of symptoms was determined by a blinded committee review of each participant's symptoms.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.|||hours||Full Range|Median
1366273|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST knee flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
1366262|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase|Score 1 was based on a subset of symptoms including: elevated oral temperature, myalgia, nausea, abdominal cramps, bloating, diarrhea, and vomiting. Score 2 was based on all Score 1 symptoms plus fatigue/malaise, chills, and loss of appetite. Total Score 1=0 to 20 and Total Score 2=0 to 29. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.|||score on a scale||Standard Deviation|Mean
1366263|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Modified Vesikari Scoring System During the Inpatient Phase|Vesikari Scoring System assesses the following symptoms: duration of diarrhea (days), maximum number of diarrheal stools/24 hours, duration of vomiting (days), maximum number of vomiting episodes/24 hours, fever and dehydration. Since the typical inpatient phase was four days in length, the duration of diarrhea scoring was modified to fit this time frame. Modified Vesikari Scale Total Score=0 to 17. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.|||score on a scale||Standard Deviation|Mean
1366264|NCT01609257|Secondary|Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool||Pre Challenge to 30 Days Post Challenge|MITT population included all participants who received at least one dose of study drug, Challenge stage.|||percentage of participants|||Number
1366265|NCT01609257|Primary|Percentage of Participants With Serious Adverse Events (SAEs) 365 Days Following the Last Study Vaccination|A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|365 Days Following Dose 2 (Up to 393 days)|MITT population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
1366266|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 2|Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.|||percentage of particpants||95% Confidence Interval|Number
1366267|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 1|Systemic signs or symptoms included: elevated daily oral temperature (fever), headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 1|MITT included all participants who received at least one dose of study drug. Data is missing for 2 participants.|||percentage of particpants||95% Confidence Interval|Number
1366268|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 2|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.|||percentage of participants||95% Confidence Interval|Number
1366269|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 1|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 1|MITT population included all participants who received at least one dose of study drug. Data is missing for 2 participants.|||percentage of participants||95% Confidence Interval|Number
1366270|NCT01609257|Primary|Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer|Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR >400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Modified intent-to-treat population (mITT) included all participants who received at least one dose of study drug, challenge stage.|||percentage of participants|||Number
1366271|NCT01609062|Secondary|Adolescent Pediatric Pain Tool (APPT) - Pain Intensity|"The APPT is a validated, multidimensional tool to evaluate pain in children, adolescents, and young adults. The complete APPT is measured in three parts - Part 1 of the APPT scale determines the subject's pain locations using a body template. Part 2 of the APPT scale determines the intensity of the pain using a 10 cm visual analog scale (VAS) with the lowest point of the scale (0) labeled No Pain and the highest point on the scale (10) labeled Worst Possible Pain. Intermediate regions of the sale were labeled with 3 intermediate descriptors (Little Pain, Medium Pain, and Large Pain). Part 3 of the APPT scale characterizes the pain by tracking the number and percentage of words selected by subjects to describe their pain from a total of 57 choices. Part 2 corresponds most closely to other typically used pain scales (based on VAS) and for this reason the results from Part 2 are presented here.~Change from baseline to Week 12, 24, and 52 in pain intensity."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat|||units on a scale||Standard Deviation|Mean
1366272|NCT01609062|Secondary|Muscle Strength Testing (MST) - Elbow Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST elbow flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
1366275|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Aerobic Efficiency|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET Aerobic Efficiency (ml/watt).~Note that decline in Aerobic Efficiency translate into an improvement"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
1366276|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - O2 Pulse|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET O2 pulse (ml/beat)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
1366277|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Peak Workload|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET Peak workload (watt)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
1366278|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Duration of Exercise|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Change from baseline to Week 25 and 52 as measured by the CPET Duration of Exercise (min)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
1366279|NCT01609062|Secondary|Normalized Urine Keratan Sulfate (uKS)|"Urinary KS was measured by a quantitative method and normalized using the sample urinary creatinine measurement.~Percent change from baseline to Week 12, 24, and 52 in normalized urine keratan sulfate (ug/mg)."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
1366280|NCT01609062|Secondary|Respiratory Function Test (MVV and FVC)|"Respiratory Function was assessed by spirometry in accordance with American Thoracic Society standards.~Percent change from baseline to Week 12, 24, and 52 as measured by Maximum Voluntary Ventilation (MVV, L/min) Percent change from baseline to Week 12, 24, and 52 as measured by Forced Vital Capacity (FVC, L)"|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
1366281|NCT01609062|Secondary|3-minute Stair Climb Test (3MSCT)|Change from baseline to Week 12, 24, and 52 as measured in speed (stairs/min) in 3MSCT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set|||stairs/min||Standard Deviation|Mean
1366282|NCT01609062|Secondary|6-minute Walk Test (6MWT)|Change from baseline to Week 12, 24, and 52 as measured in distance walked (meters) in 6MWT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set|||meters||Standard Deviation|Mean
1366283|NCT01609062|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).~The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 192 weeks or ETV (early termination visit)|The primary outcome measure data is presented in more detail under the Adverse Events section.|||participants|||Number
1366284|NCT01609023|Secondary|Time to Progression (TTP) Assessed Using Local Standards|TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis.|From enrollment until disease progression or death, assessed up to 26 months|ITT population|||months||95% Confidence Interval|Mean
1366285|NCT01609023|Secondary|Percentage of Participants With PR Assessed Using Local Standards|Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
1366286|NCT01609023|Secondary|Percentage of Participants With CR Assessed Using Local Standards|Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
1366287|NCT01609023|Secondary|Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards|Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
1366288|NCT01609023|Secondary|Percentage of Participants With Disease Progression or Death Assessed Using Local Standards|PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
1366359|NCT01607853|Secondary|Change From Baseline in Erythema at Day 8.|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8||||units on a scale||Standard Deviation|Mean
1366289|NCT01609023|Secondary|Progression-Free Survival (PFS) Assessed Using Local Standards|PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis.|From enrollment until disease progression or death, assessed up to 24 months|ITT population|||months||95% Confidence Interval|Median
1366290|NCT01609023|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 24 months|Safety population included all eligible participants.|||percentage of participants|||Number
1366291|NCT01609010|Secondary|Overall Survival|The median time, in months, from randomization to OS event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||months||Full Range|Median
1366292|NCT01609010|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|An overall survival event was defined as death due to any cause.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
1366293|NCT01609010|Secondary|Time to Disease Progression|The median time, in months, from randomization to disease progression event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||months||95% Confidence Interval|Median
1366294|NCT01609010|Secondary|Disease Progression - Percentage of Participants With an Event|A disease progression event was defined as tumor progression or death due to any cause (or a censored observation).|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
1366295|NCT01609010|Secondary|Duration of Response|The median time, in months, from the date of the first observation of CR, CRu, or PR and the date of progressive disease (PD), censored observation, or death due to any cause. PD was defined as an increase of >50% compared to BL in the sum of the product of the two largest perpendicular parameters of measurable lymphoma, or the occurrence of new lesions. One month=30.4 days. Response duration was calculated amongst responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population; n=number of participants assessed for the specified parameter at a given visit. Only participants with a response (CR+CRu+PR, CR+CRu, or CR only) were included in the analysis.|||months||95% Confidence Interval|Median
1366296|NCT01609010|Secondary|Duration of Response - Percentage of Participants With an Event|Response duration was defined as the period between the date for first observation of CR, CRu or PR and the date of progressive disease (PD), censored observation or death of any cause. Response duration was also assessed for response defined as CR only. Response duration was calculated among responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
1366297|NCT01609010|Secondary|Percentage of Participants Achieving CR or CRu|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes >1 cm or nodes >1.5 cm observed in CATscan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate.|Weeks 10 and 16|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants||95% Confidence Interval|Number
1366298|NCT01609010|Secondary|Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes greater than (>) 1 centimeter (cm) or nodes >1.5 cm observed in computerized axial tomography (CAT) scan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate. PR was defined as a decrease of greater than or equal to (≥) 50 percent (%) compared with the BL value in the sum of the products of the two largest perpendicular diameters in all measurable and evaluable lesions; and a ≥50% reduction of the size from BL if hepato-splenomegaly was present.|Weeks 10 and 16|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.|||percentage of participants||95% Confidence Interval|Number
1366299|NCT01609010|Primary|Treatment Failure - Time to Event|The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||months||95% Confidence Interval|Median
1366300|NCT01609010|Primary|Treatment Failure - Percentage of Participants With an Event|Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment.|Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
1366301|NCT01608971|Primary|Rotem MCF Fibtem and MCF Intem|The following parameters of the INTEM test will be analyzed: MCF [mm] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF [mm] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.|15 Minutes after protamine infusion|Patients of both groups|||mm||Inter-Quartile Range|Median
1366302|NCT01608971|Secondary|12 h Postoperative Blood Loss|The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.|15 min after protamine administration until 12 hours postoperatively||||ml/12 hour||Inter-Quartile Range|Median
1366303|NCT01608971|Secondary|Transfusion of Blood Products and Coagulation Factors|The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .|From protamine administration until 12 h after surgery|Transfusion of RBC|||percentage of patients transfused|||Number
1366317|NCT01608659|Secondary|Inter-Injection Interval Duration of Each Treatment Period|Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.|||Days||Full Range|Median
1366304|NCT01608971|Primary|INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer|The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT [seconds](coagulation time), CFT [seconds] (clot formation time) and the CT [seconds] of the HEPTEM test which is non sensitive for residual heparine.|Tests will be measured 15 minutes after Protamine infusion|Rotem INTEM CT, CFT, MCF and FIBTEM MCF and Heptem CT|||seconds||Inter-Quartile Range|Median
1366305|NCT01608815|Secondary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site (children): Pain Incapacitating, unable to perform usual activities; Erythema and Swelling ≥ 50 mm; Grade 3 injection site (adults and adolescents): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 systemic reactions: Fever, ≥39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1366306|NCT01608815|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titer Ratios were assessed in the Immunology Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
1366307|NCT01608815|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Titers were assessed in the Immunology Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1366308|NCT01608815|Primary|Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine|Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|Vi antibody titers were assessed in the Immunology Analysis Set.|||Participants|||Number
1366309|NCT01608724|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)||Week 24|Patients who participated in standard noodle test in the per-protocoal analysis set (PPS), which included patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||mmol/L||Standard Error|Mean
1366310|NCT01608724|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)||Weeks 6, 12, 18, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||mmol/L||Standard Error|Mean
1366311|NCT01608724|Secondary|Proportion (%) of Patients Achieving HbA1c <7%||Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||Percentage|||Number
1366312|NCT01608724|Primary|Absolute Change From Baseline in Haemoglobin A1c (HbA1c)|Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.|Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||(%)||Standard Error|Mean
1366313|NCT01608672|Secondary|Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire|"Physicians rated their overall satisfaction with BOTOX® treatment by answering the question on the Physician Reported Overall Satisfaction of Effectiveness Questionnaire: You have treated this patient with BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants where the physician answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.|||Percentage of participants|||Number
1366314|NCT01608672|Secondary|Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire|"Participants rated their overall satisfaction with BOTOX® treatment by answering the question on the Patient Reported Overall Satisfaction of Effectiveness Questionnaire: You have received BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants who answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.|||Percentage of participants|||Number
1366315|NCT01608672|Primary|Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)|Participants assessed their overall satisfaction with their glabellar lines by answering FLSQ Question 5: “How satisfied are you with the effect your treatment had on your facial lines?” using a 5-point scale where: -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.|||Percentage of participants|||Number
1366316|NCT01608659|Secondary|Percent of Subjects Reporting Satisfaction With Treatment Effects|Percent of subjects reporting satisfaction with treatment effects per chart notes.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.|||Percentage of Subjects||Standard Deviation|Mean
1366347|NCT01607853|Secondary|Change From Baseline in Scaling at Day 8|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8||||units on a scale||Standard Deviation|Mean
1366318|NCT01608659|Primary|Average Total Dose Per Treatment Period|Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.|||Units||Standard Deviation|Mean
1366319|NCT01608490|Secondary|Mean Percent Change in FEV1|Mean percent change in FEV1 at 12 months|BL to 12 months||||percentage change||Standard Error|Mean
1366320|NCT01608490|Primary|Meters: 6 Minute Walk Test|mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups|baseline through 12 months follow up|Patients who were analyzed at 12 months.|||meters||Standard Error|Mean
1366321|NCT01608321|Primary|Change in the Brief Pain Inventory (Short Form) Score|The Brief Pain Inventory (BPI) is one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The basic pain scale rating is a rating of 0-10 with 0 as no pain, and 10 the worst pain imaginable.|Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)|One patient did not meet study entry criteria at baseline (pain scale score = 0), so was not included in the analysis|||units on a scale||Standard Deviation|Mean
1366322|NCT01608308|Secondary|Postoperative Vital Sign (Respiratory Rate)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||breaths per minute||Standard Deviation|Mean
1366323|NCT01608308|Secondary|Postoperative Vital Sign (Temperature)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||Fahrenheit||Standard Deviation|Mean
1366324|NCT01608308|Secondary|Postoperative Vital Sign (Pulse)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||beats per minute||Standard Deviation|Mean
1366325|NCT01608308|Secondary|Postoperative Vital Sign (Diastolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||mmHg||Standard Deviation|Mean
1366326|NCT01608308|Secondary|Postoperative Vital Sign (Systolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||mmHg||Standard Deviation|Mean
1366327|NCT01608308|Secondary|Number of Participants Who Experienced Postoperative Morbidity (Nausea)|Post-operative nausea will be monitored and measured through direct observation and nursing clinical record|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||participants|||Number
1366328|NCT01608308|Secondary|Number of Participants Who Received Intraoperative Supplemental Fentanyl|Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||participants|||Number
1366329|NCT01608308|Secondary|Total Doses of Postoperative Opiate (Morphine) Use|The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||doses||Inter-Quartile Range|Median
1366330|NCT01608308|Primary|Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale|VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain).|15 minutes and 120 minutes Post-Operatively|At the 15 minute time point, data was obtained for 24 participants in the acetaminophen group and 26 participants in the control group. For the 120 minute time point, data was obtained for 7 participants in the acetaminophen group and 11 participants in the control group.|||units on a scale||Inter-Quartile Range|Median
1366331|NCT01608295|Secondary|Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)|Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.|Baseline and Final Visit|The Arms/Groups are not combined, but results are presented as a ratio of Vilazodone/Paroxetine.|||RNA expression units||Standard Error|Mean
1366332|NCT01608295|Secondary|Neurocognitive Measure: The Rey–Osterrieth Complex Figure Test|The The Rey–Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.|Baseline and Final Visit||||units on a scale||Standard Deviation|Mean
1366333|NCT01608295|Secondary|UKU Side-effect Profile|Number of participants with each side-effect event.|Each visit for 12 weeks||||participants|||Number
1366334|NCT01608295|Primary|Hamilton Depression Rating Scale (HDRS)|The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1366348|NCT01607853|Secondary|Change From Baseline in Scaling at Day 4|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4||||units on a scale||Standard Deviation|Mean
1366335|NCT01608100|Primary|Clinical Performance- Positive Predictive Value (PPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||%MI,TnI >cutoff vs all TnI > cutoff||95% Confidence Interval|Number
1366336|NCT01608100|Primary|Clinical Performance- Negative Predictive Value (NPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||%nonMI,TnI</=cutoff vs all TnI</=cutoff||95% Confidence Interval|Number
1366337|NCT01608100|Primary|Clinical Performance- Specificity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||% nonMI with TnI </= cutoff vs all nonMI||95% Confidence Interval|Number
1366338|NCT01608100|Primary|Clinical Performance- Sensitivity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||percentage MI withTnI >cutoff vs all MI||95% Confidence Interval|Number
1366339|NCT01608100|Secondary|Prognosis|Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses.|30-day and 90-day follow-up|30 Day and 90-day prognosis (Kaplan Meier analysis) and Hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) are summarized. *Censored is defined as the subject has not experienced ACM/MACE at the indicated follow-up time point.|||participants|||Number
1366340|NCT01608100|Primary|Clinical Performance - Area Under the Curve|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||Probability||95% Confidence Interval|Number
1366341|NCT01607853|Secondary|Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22||Baseline to day 22||||millimeters||Standard Deviation|Mean
1366342|NCT01607853|Secondary|Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.||Baseline to day 22||||millimeters||Standard Deviation|Mean
1366343|NCT01607853|Secondary|Change From Baseline in Scaling at Day 22|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22||||units on a scale||Standard Deviation|Mean
1366344|NCT01607853|Secondary|Change From Baseline in Scaling at Day 18|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18||||units on a scale||Standard Deviation|Mean
1366345|NCT01607853|Secondary|Change From Baseline in Scaling at Day 15|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15||||units on a scale||Standard Deviation|Mean
1366346|NCT01607853|Secondary|Change From Baseline in Scaling at Day 11|Investigator’s rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11||||units on a scale||Standard Deviation|Mean
1366360|NCT01607853|Secondary|Change From Baseline in Erythema at Day 4.|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4||||units on a scale||Standard Deviation|Mean
1366361|NCT01607853|Secondary|Change in Total Clinical Score at Day 18 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 18||||units on a scale||Standard Deviation|Mean
1366362|NCT01607853|Secondary|Change in Total Clinical Score at Day 15 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score.|Baseline to day 15||||units on a scale||Standard Deviation|Mean
1366363|NCT01607853|Secondary|Change in Total Clinical Score at Day 11 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 11||||units on a scale||Standard Deviation|Mean
1366364|NCT01607853|Secondary|Change in Total Clinical Score at Day 8 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 8||||units on a scale||Standard Deviation|Mean
1366365|NCT01607853|Secondary|Change in Total Clinical Score at Day 4 Compared to Baseline|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 4||||units on a scale||Standard Deviation|Mean
1366366|NCT01607853|Primary|Change in Total Clinical Score From Baseline to Day 22|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score|baseline to day 22||||units on a scale||Standard Deviation|Mean
1366367|NCT01607658|Secondary|Change in Global Sexual Functioning From Day 0 to Day 84|as measured by Female Sexual Function Index (FSFI) on Day 0 and 84, respectively. The FSFI, a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual frustration in women. The questionnaire provides scores on 6 domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) as well as a total score. Fifteen items are rated on a 6-point Likert scale (from 0 to 5) and 4 items on a 5-point Likert scale (from 1 to 5). The scores are added and converted using a conversion factor so that the maximum score for each domain is 6. The overall FSFI score can range from 2 to 36. Higher scores indicate better or higher sexual function.|Day 0 and Day 84|The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.|||units on a scale||Standard Deviation|Mean
1366368|NCT01607658|Secondary|Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84|as measured by Female Sexual Distress Scale (FSDS-DAO) Question #15 on Day 0 and 84, respectively. Question #15 evaluates the level of distress related to problems with orgasm. It is rated on a 5-point Likert scale (from 0 to 4, i.e. never [0], rarely [1], occasionally [2], frequently [3], or always [4]). Higher scores indicate more distress.|Day 0 and Day 84|The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.|||units on a scale||Standard Deviation|Mean
1366369|NCT01607658|Secondary|Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)|"as measured by Monash Women's Health Program Female Sexual Satisfaction Questionnaire (MONASH WHP FSSQ) question 11.~MONASH WHP FSSQ question 11 asks participants to comment on how satisfying they found the sex to be from Not at all to Very much so. The lowest score is 1 and the highest is 9. All scores for each 28-day period were averaged. Change from baseline was obtained by subtracting baseline 28-day average from the 28-day period at the end of the study (Day 57 to 84)."|Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)|The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.|||units on a scale||Standard Deviation|Mean
1366370|NCT01607658|Primary|Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period||84 days|ITT Population|||orgasms||Standard Deviation|Mean
1366371|NCT01607645|Secondary|Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.|||days||Full Range|Mean
1366372|NCT01607645|Secondary|Duration of Moderate Neutropenia Defined as an ANC Less Than 1000||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.|||days||Full Range|Mean
1366373|NCT01607645|Secondary|Duration of Severe Neutropenia Defined as an ANC Less Than 500||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.|||days||Full Range|Mean
1366374|NCT01607645|Secondary|Severe Prolonged Aplasia||Assessed for up to 45 days||||Participants|||Count of Participants
1366375|NCT01607645|Secondary|Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0||Assessed for up to 3 months after completion study treatment|We have analyzed 4 and 3 patients in each arm, respectively. One patient in each of the arms completed 2 cycles of therapy. The numbers provided in the Outcome Measure Data Table in Frequency and Severity of Grade 3, 4, and 5 Toxicities are the numbers of patients with each specified event.|||Participants|||Count of Participants
1366376|NCT01607645|Secondary|TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine||Assessed for up to Day 30||||Participants|||Count of Participants
1366377|NCT01607645|Secondary|CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years||||Participants|||Count of Participants
1366382|NCT01607645|Secondary|Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM||Assessed for up to 90 days||||Participants|||Count of Participants
1366383|NCT01607645|Primary|Number of Participants Who Achieved Morphologic CR|Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, <5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease|Participants were monitored up until the point when they went off study following completion of the treatment (3 months)||||participants|||Number
1366384|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Up to 6 years|FAS was defined as those who had a record of either CGI-I or CGI-S.|||Participants|||Number
1366385|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Start of administration|FAS was defined as those who had a record of either CGI-I or CGI-S.|||Participants|||Number
1366386|NCT01607593|Primary|Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation|Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse.|Up to 6 years|Full analysis set (FAS) was defined as those who had a record of either CGI-I or Clinical Global Impression of Severity (CGI-S).|||Participants|||Number
1366387|NCT01607554|Secondary|Median Overall Survival (OS)||100 months|No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
1366388|NCT01607554|Secondary|Median Duration of Response||Up to 100 months|No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
1366389|NCT01607554|Secondary|Progression Free Survival (PFS)||Up to 100 months|No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
1366390|NCT01607554|Secondary|Toxicity of Irinotecan Salvage Chemotherapy|Use blood samples to measure possible 1) Neutropenia, 2) Thrombocytopenia, 3)Diarrhea; 4) Other measures of toxicity other than alopecia, anorexia, and asthenia as listed in the National Cancer Institute Common Toxicity Criteria v. 4.03|2 days preceding each cycle of therapy|There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
1366391|NCT01607554|Secondary|Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy|Patients who have a loss of SULF2 gene expression have a better outcome than those whose tumors express SULF2. High level of ISG15 expression in NSCLC may indicate a subgroup of tumors that may be more sensitive to the cytotoxic effects of irinotecan. In patients who consent to screening, 10 unstained slides of archived diagnostic tissue will be obtained from formalin-fixed, paraffin-embedded specimens and analyzed in the laboratories of our Lovelace Respiratory Research Institute co-investigators.|1 year|No data was collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
1366392|NCT01607554|Secondary|Time to Progression (TTP)|Time to progression will be measured from the time of first treatment until there is evidence of progressive disease or death, from the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 100 months. Death will be treated as a progression event.|Up to 100 months|No data were collected on this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
1366393|NCT01607554|Primary|Tumor Response|Change in tumor size will be measured by CT scan using RECIST criteria.|8 weeks|Both participants experienced an increase in tumor size between the time of the baseline CT scan and the first study CT scan. There will be no publication or further data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.|||Participants|||Count of Participants
1366394|NCT01607476|Primary|Global Distribution of F18 Flutemetamol in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.~The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug||||standard uptake value ratio||Standard Deviation|Mean
1366407|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 8, participants were asked to rate how much energy they have on a scale of 0 to 5: 0, “I have lots of energy”; 5, “I have no energy at all.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366395|NCT01607476|Primary|Global Distribution of C11 PiB in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.~The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug||||standard uptake value ratio||Standard Deviation|Mean
1366396|NCT01607450|Secondary|GLP-1 Concentrations|Achieved GLP-1 concentrations at the end of the 12 hour treatment exposure|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed|||pmol/L||Standard Deviation|Mean
1366397|NCT01607450|Secondary|Cardiac Index|Impedance cardiography-derived measurement of cardiac index, assessed following 12 hour exposure to treatment condition concurrent with the PET measurements.|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed|||L/min/m^2||Standard Deviation|Mean
1366398|NCT01607450|Secondary|Myocardial Total Oxidation Rate|MVO2 derived from acetate kinetics|After 12 hours of GLP-1 exposure||||ml/min/100g||Standard Deviation|Mean
1366399|NCT01607450|Secondary|Myocardial Blood Flow|Myocardial perfusion derived from acetate kinetics|After 12 hours of GLP-1 exposure||||ml/min/100g||Standard Deviation|Mean
1366400|NCT01607450|Primary|Myocardial Glucose Uptake.|Myocardial glucose uptake measured using 18FDG PET, quantified using a 3-compartment model with a lumped constant of 1.0.|After 12 hours of glucagon-like peptide 1 (GLP-1) exposure||||umol/min/100g||Standard Deviation|Mean
1366401|NCT01607411|Secondary|Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens|||μg*F/cm^2||Standard Error|Mean
1366402|NCT01607411|Secondary|Percent Net Acid Resistance (%NAR) of Enamel Specimens|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.|||%NAR||Standard Error|Mean
1366403|NCT01607411|Secondary|%SMHR of Enamel Specimens Exposed to Test Treatments|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.|||%SMHR||Standard Error|Mean
1366404|NCT01607411|Primary|Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.|||%SMHR||Standard Error|Mean
1366405|NCT01607398|Secondary|Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period|The occurrence of a COPD exacerbation was assessed on each day of evaluation during the treatment period per the defined severity classifications. COPD exacerbations were classified based on severity as a mild exacerbation (exacerbation of COPD symptoms were manageable by the participant, not requiring systemic corticosteroid or antimicrobial therapy), a moderate exacerbation (exacerbation of COPD symptoms required systemic corticosteroid or antimicrobial therapy), or a severe exacerbation (exacerbation of COPD symptoms required hospitalization). The number of participants who experienced 0, 1, 2, and >=3 exacerbation(s) was summarized.|From Baseline up to Week 12|Per Protocol Population|||Participants|||Number
1366406|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8; each question scored from 0 to 5) designed to assess the health status of participants with COPD. The total score is calculated as the sum of the scores from Questions 1 to 8, for a range of possible scores of 0 to 40. A higher total score represents a lower quality of life, and vice versa. Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366408|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 7, participants were asked to rate how soundly they sleep on a scale of 0 to 5: 0, “I sleep soundly”; 5, “I don't sleep soundly because of my lung condition.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366409|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 6, participants were asked to rate how confident they are leaving home despite their lung condition on a scale of 0 to 5: 0, “I am confident leaving my home despite my lung condition”; 5, “I am not at all confident leaving my home because of my lung condition.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366410|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 5, participants were asked to rate how limited they are in doing activities at home on a scale of 0 to 5: 0, “I am not limited doing any activities at home”; 5, “I am very limited doing activities at home.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366411|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 4, participants were asked to rate how breathless they feel when walking up a flight of stairs or a hill on a scale of 0 to 5: 0, “When I walk up a hill or one flight of stairs I am not breathless”; 5, “When I walk up a hill or one flight of stairs I am very breathless.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366412|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 3, participants were asked to rate how tight their chest feels on a scale of 0 to 5: 0, “My chest does not feel tight at all”; 5, “My chest feels very tight.” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366413|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 2, participants were asked to rate the amount of phlegm (mucus) in their chest on a scale of 0 to 5: 0, “I have no phlegm (mucus) in my chest at all”; 5, “My chest is completely full of phlegm (mucus).” Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366414|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 1, participants were asked to rate how much they cough on a scale of 0 to 5: 0, I never cough; 5, I cough all the time. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
1366415|NCT01607398|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Respiratory function tests were performed for the measurement of FEV1 and FVC at Baseline and at Week 12. The values were measured at 15 to 60 minutes following the use of a pressurized metered-dose inhaler. Three technically acceptable values were obtained, and the highest value was recorded. Change from Baseline in FEV1 and FVC was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population|||Liters (L)||Inter-Quartile Range|Median
1366416|NCT01607398|Secondary|Change From Baseline in Fibrinogen Levels in Serum at Week 12|Per Protocol Amendment 4, the measurement of fibrinogen levels in serum was removed from the analysis plan because fibrinogen levels were found to be too low and too difficult to measure.|Baseline and Week 12|||||||
1366417|NCT01607398|Secondary|Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of hsCRP, SP-D, and CC16 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in hsCRP, SP-D, and CC16 was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population|||ng/mL||Inter-Quartile Range|Median
1366418|NCT01607398|Secondary|Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of IL-6 and IL-8 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in IL-6 and IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population|||pg/mL||Inter-Quartile Range|Median
1366419|NCT01607398|Secondary|Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of MPO and SP-D in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in MPO and SP-D levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Inter-Quartile Range|Median
1366420|NCT01607398|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12|Data cannot be reported because hsCRP was under the lower limit of detection in all samples.|Baseline and Week 12|||||||
1366421|NCT01607398|Secondary|Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of IL-8 in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.|||Picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
1366422|NCT01607398|Secondary|Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12|INF-gamma-positive cells and perforin-positive cells were not detected in samples collected in this study due to the conditions of the samples and/or antibodies. No re-assays were performed, “no result”/”no data” was entered into the case report forms, and no statistical analysis or data summarization was performed.|Baseline and Week 12|||||||
1366423|NCT01607398|Secondary|Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. All inflammatory cells in induced sputum were counted with the use of a cytological specimen of cells in the induced sputum. Change from Baseline in all inflammatory cell count was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.|||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
1366424|NCT01607398|Primary|Change From Baseline in Neutrophil Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).|Baseline and Week 12|Per Protocol Population: all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. Only those participants available at the specified time points were analyzed.|||ratio (%)||Inter-Quartile Range|Median
1366425|NCT01607346|Secondary|Change From Baseline in PVR Volume by Bladder Ultrasound at Visits 3, 4, 5 and 6|PVR is the the amount of urine left in the bladder after urination. Bladder ultrasound was performed to assess PVR at Baseline/Visit 2 (Day -1), Visit 3 (Day 21), Visit 4 (Day 35), Visit 5 (Day 49) and Visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 80 (Visit 6)|Safety Population|||mL||Standard Deviation|Mean
1366426|NCT01607346|Secondary|Cystometry Assessment at Visits 3, 4, 5 and 6|Cystometry is a test of bladder function in which pressure and volume of fluid in the bladder is measured during filling, storage, and voiding. Cystometry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). The requirement for cystometry was discovered by the study monitor and discussed with the GSK medical monitor after the participants had completed the study.|Up to Day 80 (Visit 6)|Data were not collected, although 3 participants met at least 1 of the criteria for multichannel cystometry during the study, the assessment was not performed.||||||
1366427|NCT01607346|Secondary|Change From Baseline in American Urological Association Symptom Index (AUA SI) at Visits 3, 4, 5 and 6|The America Urological Association Symptom Index is a 7-item Likert-scored scale describing urinary bladder function. It is the sum of the responses to the 7 AUA symptom questions. Score ranges from 0 to 5 (0=not at all and 5=almost always for questions 1 to 6; 0=None and 5=five times or more for question 7). The total score ranges from 0-35 where higher scores indicate more severe symptoms. It was completed by the investigator at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Scores on a scale||Standard Deviation|Mean
1366428|NCT01607346|Secondary|Volume Voided as Recorded on the Voiding Diary for 2 Days Prior to Each Post-baseline Visit|The participants were asked to complete a voiding diary for two days preceding each visit. Volume voided for 2 days prior to each visit was defined as sum of urine recorded within 2 days prior to each post-baseline visit. Voiding diary was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL||Standard Deviation|Mean
1366429|NCT01607346|Secondary|Frequency of Micturition as Recorded on the Voiding Diary for 2 Days Prior to Each Visit|The participants were asked to complete a voiding diary for two days preceding each visit. Frequency of micturition for 2 days prior to dach visit was defined as total number of entries recorded within 2 days prior to each post-baseline visit. Voiding diary was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Micturition voided||Standard Deviation|Mean
1366430|NCT01607346|Secondary|Change From Baseline in Average Flow Rate (Qmean) at Visits 3, 4, 5 and 6|Average flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL per second||Standard Deviation|Mean
1366431|NCT01607346|Secondary|Change From Baseline in Flow Time at Visits 3, 4, 5 and 6|Flow time was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Seconds||Standard Deviation|Mean
1366432|NCT01607346|Secondary|Change From Baseline in Time to Maximum Flow at Visits 3, 4, 5 and 6|Time to maximum flow was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Seconds||Standard Deviation|Mean
1366433|NCT01607346|Secondary|Change From Baseline in Voided Volume (VV) at Visits 3, 4, 5 and 6|The volume of urine voided was measured by uroflowmetry test. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL||Standard Deviation|Mean
1366434|NCT01607346|Secondary|Change From Baseline in Percentage Residual Urinary Volume (RUV) at Visits 3, 4, 5 and 6|Percentage residual urinary volume is a standardized measure of post-residual volume and is defined as residual devided by residual plus voided multiplied by 100 where 'residual' is the post-void residual (PVR) volume collected on the bladder ultrasound and 'voided' is the voided volume collected on the uroflowmetry. Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated as post-baseline minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Percentage of residual urinary volume||Standard Deviation|Mean
1366435|NCT01607346|Secondary|Percent Change From Baseline in Qmax at Visits 3, 4, 5 and 6|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. The percentage change from Baseline was calculated as post-baseline value minus Baseline value divided by Baseline value multiplied by 100. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Percent change||Standard Deviation|Mean
1366436|NCT01607346|Secondary|Change From Baseline in Maximum Flow Rate (Qmax) at Visits 3, 4 and 6|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL per second||Standard Deviation|Mean
1366437|NCT01607346|Primary|Change From Baseline in Maximum Flow Rate (Qmax) at Visit 5.|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3, 4 and 5 (Days 21, 35 and 49 respectively). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value at Visit 5. Safety Population was defined as all participants who received more than or equal to one dose of study medication.|Baseline (Day -1) and on Day 49 (Visit 5)|Safety Population|||Milliliter (mL) per second||Standard Deviation|Mean
1366438|NCT01607320|Secondary|Ovulation|If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.|Cycle day 22-24|||||||
1366439|NCT01607320|Primary|Pregnancy|Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.|4 months|The study was randomized between the two treatments and was never unblinded, therefore randomization is unknown and data collection is incomplete.||||||
1366440|NCT01607203|Secondary|Patients With Cryopreserved Embryos||4 weeks||||patients with cryopreserved embryos|||Number
1366441|NCT01607203|Secondary|Pregnancy Rate|the number of pregnancies obtained, wich still is the most important issue for the patients|12 weeks||||pregnancies|||Number
1366442|NCT01607203|Primary|MII Oocytes|the number of mature oocytes retrieved|3 weeks||||cumulus oocyte complex||Standard Deviation|Mean
1366443|NCT01607112|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-21)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1366444|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day follow-up period (Days 0-20) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1366445|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.~Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C"|During the 4-day follow-up period (Day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
1366446|NCT01607112|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Days||Full Range|Median
1366447|NCT01607112|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Day 0-Day 3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented.|||Subjects|||Number
1366448|NCT01607112|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Days||Full Range|Median
1366449|NCT01607112|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1366450|NCT01607112|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1366451|NCT01607112|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1366452|NCT01607112|Secondary|Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1366453|NCT01607112|Secondary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1366454|NCT01607112|Secondary|Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
1366455|NCT01607112|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1366456|NCT01607112|Primary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1366457|NCT01607112|Primary|Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
1366458|NCT01606852|Secondary|Number of Participants With Adverse Events|arterial hypotension, bradycardia, self-extubations, and protocol violations related to drug, pump or both.|During 5 days of study protocol||||participants|||Number
1366459|NCT01606852|Primary|Aggregate Sedative Exposure During PCS Use (up to 5 Days).|Will use the sedation intensity score Scale is based on a score of 1 (full arousal) to 4 (no arousal)|5 days after enrollment||||units on a scale||95% Confidence Interval|Number
1366460|NCT01606800|Primary|Number of Participants Achieving Sustained Virologic Response (SVR)|SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.|At 24 weeks after the completion of therapy (up to 72 weeks)|All Treated Population, which included all participants who received at least one dose of study medication after RVR.|||Participants|||Number
1366461|NCT01606787|Secondary|Difference in eGFR|between treatment groups at 6 weeks (+/- 4 weeks) after surgery with postoperative eGFR as the outcome, and treatment group, surgical technique, and preoperative eGFR as covariates. We will also use the ANCOVA on the absolute level of eGFR because this has the greatest statistical power. However, the estimate produced by ANCOVA - a mean difference in eGFR levels - is of incomplete clinical interpretability.|6 weeks||||% change from preoperative eGFR||Standard Deviation|Mean
1366462|NCT01606787|Primary|Difference in eGFR|The difference will be assessed with an ANCOVA model with eGFR 6 months after surgery (+/- 2 months) as the outcome and treatment group, surgical technique, and preoperative eGFR as covariates. We will report a two-tailed p-value and a 95% confidence interval for the difference between groups. If a patient does not have an eGFR measurement between 5-7 months after surgery and has both a measurement between 3-5 months and 7-12 months after surgery, then the 6 month eGFR measurement will be linearly interpolated.|6 months||||% change from preoperative eGFR||Standard Deviation|Mean
1366463|NCT01606761|Secondary|Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24|The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.|Week 24|Efficacy full analysis set included all participants who were randomized into the study.|||Percentage of Participants|||Number
1366464|NCT01606761|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24|The ACR 50 Response is defined as >= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|Week 24|Efficacy full analysis set included all participants who were randomized into the study.|||Percentage of Participants|||Number
1366465|NCT01606761|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 24|Efficacy full analysis set included all participants who were randomized into the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
1366479|NCT01606735|Primary|Anterior Chamber Cell Count at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.|8 days post-treatment||||percentage of patients with ACC clearing||95% Confidence Interval|Number
1366601|NCT01605916|Primary|Cmax of Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1366466|NCT01606761|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|Week 16|Efficacy full analysis set included all participants who were randomized into the study.|||Percentage of Participants|||Number
1366467|NCT01606748|Primary|PK: Dose Normalized AUC(0-∞) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1366468|NCT01606748|Primary|PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366469|NCT01606748|Primary|PK: Dose-Normalized AUC(0-5) of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1366470|NCT01606748|Secondary|PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366471|NCT01606748|Primary|PK: Dose-Normalized AUC(0-24) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1366472|NCT01606748|Secondary|PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1366473|NCT01606748|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 14 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1366474|NCT01606748|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline through, 30-Day Follow-Up|All participants who received at least one dose of study drug and had evaluable baseline and postbaseline data for antibodies.|||participants with immunogenicity samples|||Number
1366475|NCT01606748|Primary|PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ug*hour(h)/mL||Geometric Coefficient of Variation|Geometric Mean
1366476|NCT01606748|Primary|PK: Dose-Normalized Cmax of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||nanogram (ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1366477|NCT01606748|Primary|PK: Dose-Normalized Cmax of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||nanogram(ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1366478|NCT01606748|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
1366635|NCT01605825|Other Pre-specified|Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale||Days 1, 8, 15, 22, 29, and 36|||||||
1366480|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score|The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status.|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.|||units on a scale||Standard Deviation|Mean
1366481|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and 67 patients had complete data for UPDRS Part III. Thus, of the 70 patients in the FAS, 67 patients are included in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
1366482|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 67 patients had complete data for UPDRS Part III and are included in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
1366483|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and are included in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
1366484|NCT01606670|Primary|Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire|"The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF).~The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable).~8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain.~The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable."|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.|||units on a scale||Standard Deviation|Mean
1366485|NCT01606319|Secondary|Health Care Utilization|frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||unscheduled health visits per 46 weeks||95% Confidence Interval|Mean
1366486|NCT01606319|Secondary|Asthma Rescue Medication Use|average albuterol rescue use per week, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||inhalations per week||95% Confidence Interval|Mean
1366487|NCT01606319|Secondary|Asthma Control Days|proportion of study days on which asthma was controlled, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||proportion of days||95% Confidence Interval|Mean
1366488|NCT01606319|Primary|Exacerbation Frequency|the number of asthma exacerbations requiring systemic corticosteroids|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||asthma exacerbations per 46 weeks||95% Confidence Interval|Mean
1366489|NCT01606306|Primary|Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.|The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthcare visits. Children were defined as differential responders if, first, the time to an asthma exacerbation was at least four weeks longer, or second, if the number of annualized ACDs was at least 31 days more for one treatment than another, in that order. If neither threshold was met, the participant was considered a non differential responder. Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.|The last 14 weeks of each 16-week treatment period|Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.|||probability||95% Confidence Interval|Number
1366636|NCT01605825|Other Pre-specified|Manual Dexterity as Measured by the Box and Block Test||Days 1, 8, 15, 22, 29, and 36|||||||
1366490|NCT01606254|Secondary|Number of Participants With Clinical Global Impression Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 8, 22, 50, 78 and 92|The PPS included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. LOCF imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.|||Participants|||Number
1366491|NCT01606254|Secondary|Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Day 8, 22, 50, 78 and 92|Per protocol set (PPS) included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. Last observation carried forward (LOCF) imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1366492|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 218|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1366493|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 162|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1366494|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 120|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1366495|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 92|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1366496|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 78|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1366497|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 50|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1366498|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 22|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1366637|NCT01605825|Other Pre-specified|Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)||Screening visit, Days 1, 8, 15, 22, 29, and 36|||||||
1366499|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 8|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once.|||Participants|||Number
1366500|NCT01606254|Primary|Paliperidone Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Days||Standard Deviation|Mean
1366501|NCT01606254|Primary|Plasma Paliperidone Concentration at Steady State (Css av)|The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1366502|NCT01606254|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
1366503|NCT01606254|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Days||Full Range|Median
1366504|NCT01606254|Primary|Maximum Observed Plasma Concentration (Cmax) of Paliperidone|The Cmax is defined as maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1366505|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92|The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.|Day 92|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1366506|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64|The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.|Day 64|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1366507|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36|The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.|Day 36|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1366508|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8|The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).|Day 8|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
1366509|NCT01606228|Secondary|Daytime Drowsiness at Day 90|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366510|NCT01606228|Secondary|Daytime Drowsiness at Baseline|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366511|NCT01606228|Secondary|Quality of Sleep at Day 90|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366512|NCT01606228|Secondary|Quality of Sleep at Baseline|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366513|NCT01606228|Secondary|Patient Satisfaction With Paliperidone Treatment|Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).|90 days|Per Protocol (PP) population|||participants|||Number
1366514|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Day 90|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366515|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Baseline|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366516|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Day 90|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Day 90|Per Protocol (PP) population|||participants|||Number
1366517|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Baseline|Per Protocol (PP) population; participants for whom CGIS data was collected.|||participants|||Number
1366518|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Day 90|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366519|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Baseline|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
1366520|NCT01606228|Primary|The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, Day 90|Per Protocol (PP) population|||percentage of patients|||Number
1366521|NCT01606202|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the study is presented.|Up to 61 days|All randomised patients who received at least one dose of study drug were included in the Safety population.|||participants|||Number
1366522|NCT01606202|Secondary|Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment|Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366523|NCT01606202|Secondary|Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment|The Brief Pain Inventory is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366524|NCT01606202|Secondary|Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment|The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
1366525|NCT01606202|Secondary|Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment|Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.|Up to 51 days|All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366638|NCT01605825|Other Pre-specified|Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)||Screening visit, Days 1, 8, 15, 22, 29 and 36|||||||
1368629|NCT01584388|Secondary|Complete Remission (Any Timepoint), Exclusive of Serum IgG4|IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial|12 months||||Participants|||Count of Participants
1366526|NCT01606202|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366527|NCT01606202|Secondary|Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment|"Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function .~A negative value from baseline indicates a deterioration."|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366528|NCT01606202|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 (“No increase in muscle tone”) to 4 (“Affected part(s) rigid in flexion or extension”) to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366529|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||percentage of days||Standard Deviation|Mean
1366530|NCT01606202|Secondary|Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.|Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = “Mildest ever spasticity” to 10 = “Worst ever spasticity”. The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366531|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||percentage of days||Standard Deviation|Mean
1366532|NCT01606202|Secondary|Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = “Mildest ever spasm” to 10 = “Worst ever spasm”. The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366533|NCT01606202|Secondary|Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment|The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||percentage of days||Standard Deviation|Mean
1366534|NCT01606202|Primary|Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).|The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = ‘No Pain’ and 10 = ‘Worst Possible Pain’. Patients were instructed to relate ‘No Pain’ to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366535|NCT01606189|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of study is presented.|Up to 114 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
1366567|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366536|NCT01606189|Secondary|Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366537|NCT01606189|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with “no disability” and 10 equated with “total disability”. The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366538|NCT01606189|Secondary|Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as “No Pain”, “Mild”, “Discomforting”, “Distressing”, “Horrible” and “Excruciating”. The change from baseline in the number of patients who reported “No Pain” or “Mild Pain” at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
1366539|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero “No pain” to 100 “Worst possible pain”. Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366540|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)|Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = “None”, one = “Mild”, two = “Moderate” and three = “Severe”. The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366541|NCT01606189|Secondary|Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero “Worst Imaginable” to 10 “Best Imaginable”. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366542|NCT01606189|Secondary|Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as “None”, “Once”, “Twice” and “More Than Twice” and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366543|NCT01606189|Primary|Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)|Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero “no pain at all” to 10 “pain as bad as you can imagine”. The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366544|NCT01606176|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event in the study is presented.|0 - 65 days|All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis.|||participants|||Number
1366545|NCT01606176|Secondary|Patient Global Impression of Change - Multiple Sclerosis Subset.|The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||participants|||Number
1368630|NCT01584388|Secondary|Complete Remission at Any Timepoint|IgG4-RD RI = 0 at any point in the trial|12 months||||Participants|||Count of Participants
1366546|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366547|NCT01606176|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366548|NCT01606176|Secondary|Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks.|The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366549|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks.|Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366550|NCT01606176|Secondary|Use of Analgesic Escape Medication - Multiple Sclerosis Subset.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||percentage of days||Standard Deviation|Mean
1366551|NCT01606176|Secondary|Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks.|Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366552|NCT01606176|Secondary|Patient Global Impression of Change at the End of 3 Weeks of Treatment.|The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as “Very Much Improved”, “Much Improved”, “Minimally Improved”, “No Change”, “Minimally Worse”, “Much Worse” and “Very Much Worse” and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being “Very Much Improved” or “Much Improved” is presented.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||participants|||Number
1366553|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366554|NCT01606176|Secondary|Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366568|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1368631|NCT01584388|Secondary|Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months.|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.|6 months||||Participants|||Count of Participants
1366555|NCT01606176|Secondary|Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.|The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero “no disability” to 10 “total disability” scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366556|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.|Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as “No”, “Once”, “Twice”, “More than twice” and “Awake most of the night”; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366557|NCT01606176|Secondary|Use of Analgesic Escape Medication.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||percentage of days||Standard Deviation|Mean
1366558|NCT01606176|Primary|Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.|Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero “no pain” to 10 “worst possible pain”. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366559|NCT01606150|Secondary|Premature Infant Pain Profile (PIPP) Score|PIPP score assigned by a blinded outcome assessor by viewing video tapes of the infant's face during the procedure and vital sign changes during that time frame|data collected during the procedure, PIPP score assigned within one month by viewing collected data|||||||
1366560|NCT01606150|Primary|Lumbar Puncture Success Rate|Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000|immediately following the procedure|||||||
1366561|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366562|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366563|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366564|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days|All subjects who entered the study from a parent RCT investigation neuropathic pain due to multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366565|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366566|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366600|NCT01605916|Primary|Tmax of Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
1366569|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366570|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366571|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366572|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
1366573|NCT01606137|Secondary|Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1366574|NCT01606137|Secondary|Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a neuropathic pain in multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1366575|NCT01606137|Secondary|Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1366576|NCT01606137|Secondary|Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks|All subjects who entered the study from a parent randomised controlled trial (RCT) investigating the efficacy of GW-1000-02 in the treatment of spasticity associated with multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
1366577|NCT01606137|Primary|Incidence of Adverse Events as a Measure of Subject Safety.|Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.|Up to 1051 days|All subjects who took part in the extension study were included in the analysis.|||participants|||Number
1366578|NCT01606124|Secondary|Tolerability as Estimated Using the Percent Dose of Treatment Received at 6 Months|Tolerability as estimated using the percent dose of treatment received for each patient by dividing the total dose received by the targeted (i.e., protocol specified) total dose.|6 months||||percentage of targeted dose||Standard Deviation|Mean
1366579|NCT01606124|Primary|Percent Change in Rectal ACF, Pre- and Post Intervention at 6 Months|The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.|6 months|Patients with baseline and 6-month ACF data were included in this analysis.|||percentage change||Standard Deviation|Mean
1366580|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24|||Body weight Kg||95% Confidence Interval|Mean
1366581|NCT01606007|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|At Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values|||% of Participants||95% Confidence Interval|Number
1368632|NCT01584388|Secondary|Complete Remission|IgG4-RD RI (including serum IgG4) of 0 at six months|6 months||||Participants|||Count of Participants
1366582|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24|||mg/dL||95% Confidence Interval|Mean
1366583|NCT01606007|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24 (LOCF)|||MG/DL PPG||95% Confidence Interval|Mean
1366584|NCT01606007|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24|||% HbA1c||95% Confidence Interval|Mean
1366585|NCT01605942|Secondary|Plasma Levels of Dexamethasone|Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.|Day 2, Day 7, Day 14|Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis.|||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
1366586|NCT01605942|Primary|Number of Patients With Clearance of Anterior Chamber Inflammation|The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).|Up to Day 71|Safety: all patients who received study treatment at randomization/surgery (day 1)|||Patients|||Number
1366587|NCT01605916|Secondary|AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366588|NCT01605916|Secondary|Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
1366589|NCT01605916|Secondary|Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1366590|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366591|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
1366592|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1366593|NCT01605916|Primary|AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366594|NCT01605916|Primary|Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
1366595|NCT01605916|Primary|Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1366596|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366597|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
1366598|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1366599|NCT01605916|Primary|AUC(0-12) of Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1366602|NCT01605903|Primary|Number of Participants With Level 3 Postoperative Hemorrhage|Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage.|Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.||||Participants|||Count of Participants
1366603|NCT01605890|Secondary|Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24||Week 24|Participants with available measurement|||Participants|||Count of Participants
1366604|NCT01605890|Secondary|Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire|"The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:~Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated."|from Week 0 to Week 48|Participants with available PROQOL questionnaire|||Score on a scale||Inter-Quartile Range|Median
1366605|NCT01605890|Secondary|Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48||at Week 48|Participants with available measurements|||Participants|||Count of Participants
1366606|NCT01605890|Secondary|Number of Participants With Treatment Switch or Discontinuation|Overall (regardless of the molecule)|from Week 0 to Week 48||||Participants|||Count of Participants
1366607|NCT01605890|Secondary|Number of Virological Failure Participants With Resistance Mutations|Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported.|from Week 0 to Week 48||||Participants|||Count of Participants
1366608|NCT01605890|Secondary|Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence||from Week 4 to Week 48|Number of participants with available questionnaire of adherence|||percentage of participants|||Number
1366609|NCT01605890|Secondary|Number of Participants With Clinical Progression|"Clinical progression is defined as the switch:~from category A to B, C or death.~from category B to C or death."|from Week 0 to Week 48||||Participants|||Count of Participants
1366610|NCT01605890|Secondary|Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL||between Week 0 and Week 48||||percentage of participants|||Number
1366611|NCT01605890|Secondary|Median Change of CD4 Lymphocytes at Week 48||between Week 0 and Week 48||||cells/µL||Inter-Quartile Range|Median
1366612|NCT01605890|Secondary|Number of Clinical and Biological Events||from Week 0 to Week 48||||clinical and biological events|||Number
1366613|NCT01605890|Secondary|Median Change in CD4 Lymphocytes Count at Week 12||between Week 0 and Week 12||||cells/µL||Inter-Quartile Range|Median
1366614|NCT01605890|Primary|Percentage of Participants in Therapeutic Success|"The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:~Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,~CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,~Raltegravir permanent discontinuation,~Death from any cause,~New B or C events confirmed by an endpoint review committee"|at Week 48||||percentage of participants||95% Confidence Interval|Number
1366615|NCT01605877|Secondary|Percentage of Participants With Positive Response, Quality of Life Questions|"The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, Yes=visual difficulty."|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||percentage of participants|||Number
1366616|NCT01605877|Secondary|Percentage of Participants With Positive Response, Stereoscopic Vision Test|Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive).|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||percentage of participants|||Number
1366617|NCT01605877|Secondary|Mean Defocus Decimal VA (5 m)|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||decimal||Full Range|Mean
1366618|NCT01605877|Secondary|Best Corrected Near (46 cm) Contrast Sensitivity|Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||logMAR||Standard Deviation|Mean
1366677|NCT01605292|Secondary|Time to Sheath Insertion (Seconds)|Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.|Immediately during procedure (within 30 minutes)||||seconds||Standard Deviation|Mean
1366753|NCT01604265|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of the study is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
1366619|NCT01605877|Secondary|Best Corrected Far (3 m) Contrast Sensitivity|Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||logMAR||Standard Deviation|Mean
1366620|NCT01605877|Secondary|Mean Best Distance (cm) for Distance Corrected Decimal Near VA|VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||centimeters||Standard Deviation|Mean
1366621|NCT01605877|Secondary|Mean Best Distance (cm) for Uncorrected Decimal Near VA|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|"This analysis population includes all implanted subjects. Here, n is the number of participants with non-missing values at the specific time point for each arm group, respectively."|||centimeters||Standard Deviation|Mean
1366622|NCT01605877|Secondary|Uncorrected Decimal VA at Best Distance|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366623|NCT01605877|Secondary|Distance Corrected Decimal VA (40 cm)|VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366624|NCT01605877|Secondary|Uncorrected Decimal VA (40 cm)|VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366625|NCT01605877|Secondary|Distance Corrected Decimal VA (1 m)|VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366626|NCT01605877|Secondary|Uncorrected Decimal VA (1 m)|VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366627|NCT01605877|Primary|Distance-Corrected Decimal VA (50 cm)|VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366628|NCT01605877|Primary|Best Corrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366629|NCT01605877|Primary|Best Corrected Decimal VA (5 m)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366630|NCT01605877|Primary|Uncorrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366631|NCT01605877|Primary|Uncorrected Decimal VA (5 m)|Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1366632|NCT01605825|Other Pre-specified|Hand Strength as Measured by the Grip Test and Pinch Tests||Days 1, 8, 15, 22, 29, and 36|||||||
1366633|NCT01605825|Other Pre-specified|Clinician Global Impression (CGI) Scale||Days 8, 15, 22, 29 and 36|||||||
1366634|NCT01605825|Other Pre-specified|Subject Global Impression (SGI) Scale||Days 8, 15, 22, 29 and 36|||||||
1366639|NCT01605825|Primary|Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)|"A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment.~The severity categories of mild, moderate or severe, are defined below:~Mild is defined as causing no limitation of usual activities~Moderate is defined as causing some limitation of usual activities~Severe is defined as causing inability to carry out usual activities"|up to 36 days|Safety population. Number of participants analyzed is number of patients with TEAE's as described in outcome measure description. Excludes pre-treatment and post-treatment adverse events.|||participants|||Number
1366640|NCT01605799|Secondary|Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)|"The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., your feelings being easily hurt) on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days. The total score is the sum of all responses [minimum = 0 (better outcome), maximum = 212 (worse outcome)]."|The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in BSI between baseline and end of treatment will be measured using an intent to treat analysis.|||Units on a scale||95% Confidence Interval|Mean
1366641|NCT01605799|Primary|Change in PTSD Symptoms as Measured by the PCL|The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).|PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in PCL score from baseline to end of treatment will be measured using an intent to treat analysis.|||Units on a scale||95% Confidence Interval|Mean
1366642|NCT01605669|Primary|Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity|The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.|There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.||||participants|||Number
1366643|NCT01605617|Secondary|Change in Score on Overactive Bladder Questionnaire (QAB-q)|"The QAB-q is a self-administered, 33-item questionnaire containing a symptom bother and health related quality of life scale. Each item has a choice of 6 responses, ranging from not at all to a very great deal. Therefore, the total score could range from 33 (no discomfort) to 198 (great discomfort)."|Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
1366644|NCT01605617|Secondary|Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)|The IUSS has 4 levels: none, mild, moderate, and severe. An episode characterized as severe according to this scale would qualify as an urgency episode.|baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
1366645|NCT01605617|Secondary|Volume Voided Per Day||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
1366646|NCT01605617|Secondary|Number of Voids Causing Waking||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
1366647|NCT01605617|Secondary|Mean Change in Urinary Urge Incontinence Episodes in 24 Hours||Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
1366648|NCT01605617|Primary|Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
1366649|NCT01605552|Secondary|Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One case was excluded from the usual care group due to extreme values.|||change in pg/ml||Standard Deviation|Mean
1366650|NCT01605552|Secondary|Change in C-reactive Protein (CRP) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||change in mg/L||Standard Deviation|Mean
1366651|NCT01605552|Secondary|Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 Weeks|One participant in the usual care group did not complete the SCL-20 at the pre-treatment visit. Therefore a change score could not be computed for this participant. The remaining number of participants in usual care for this analysis was 13.|||Change in scores on a scale||Standard Deviation|Mean
1366652|NCT01605552|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients will undergo ultrasound assessment of brachial FMD in accordance with established guidelines. After a 10-minute supine rest, high-resolution baseline images of the brachial artery will be obtained from 3 consecutive cardiac cycles. Next, the forearm cuff will be inflated to 250 mmHg for 5 minutes and then will be rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles will be acquired. FMD values will be computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation.|0 and 12 weeks||||% increase in brachial diameter||Standard Deviation|Mean
1367169|NCT01600287|Secondary|Intra-operative Awareness|The number of patients who will be able to recall the intra-operative events when assessed postoperatively. This will be assessed by a structured protocol|Approximately 3 days and then 1 month later||||participants|||Number
1366653|NCT01605539|Secondary|Vital Signs - Temperature|"Temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Temperature will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||degrees F||Standard Error|Mean
1366654|NCT01605539|Secondary|Vital Signs - Respiratory Rate|"Respiratory rate (in breaths/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Respiratory rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||breaths per minute||Standard Error|Mean
1366655|NCT01605539|Secondary|Vital Signs - Heart Rate|"Heart rate (in beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Heart rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||beats per minute||Standard Error|Mean
1366656|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Negative Affect Assessment (NAS): 10 (minimum) – 50 (maximum). Higher score reflects stronger negative affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
1366657|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Positive Affect Assessment (PAS): 10 (minimum) – 50 (maximum). Higher score reflects stronger positive affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
1366658|NCT01605539|Secondary|Visual Analog Scale for Anxiety (VASA)|"Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). Scale: 0 (not at all anxious) - 10 (extremely anxious).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
1366659|NCT01605539|Secondary|Vital Signs - Blood Pressure|"Blood pressure (mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Blood pressure will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||mmHg||Standard Error|Mean
1366678|NCT01605292|Primary|Number of Attempts|Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.|Immediately during procedure. (up to 30 minutes)|473 patients of 698 had number of attempts measured correctly by number of forward passes. This subgroup of the whole population was used for analysis of number of attempts.|||forward attempts||Standard Deviation|Mean
1366857|NCT01603420|Secondary|Assessment of Number of GI and GU Adverse Events|"Descriptive measurements of frequency will be compiled.~This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure."|at 3 years|||||||
1366660|NCT01605539|Primary|Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)|"Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings).~** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session."|Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV||||units on a scale||Standard Error|Mean
1366661|NCT01605539|Primary|Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)|"The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test"|VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
1366662|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Faeces|Excretion of total [14C]-radioactivity in faeces|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set|||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
1366663|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Urine|Excretion of total [14C]-radioactivity in urine|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set|||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
1366664|NCT01605461|Primary|Excretion Balance of Total [14C]-Radioactivity|Excretion balance of total [14C]-radioactivity (urine and faeces)|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set|||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
1366665|NCT01605461|Primary|t1/2 of [14C]-Radioactivity in Plasma|Terminal half life (T1/2) of [14C]-radioactivity in plasma|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set|||hours||Geometric Coefficient of Variation|Geometric Mean
1366666|NCT01605461|Primary|Cmax of Plasma Deleobuvir|Maximum measured concentration (Cmax) of plasma deleobuvir|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1366667|NCT01605461|Primary|AUC0-infinity of Plasma Deleobuvir|Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic analysis set (PK set) which included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1366668|NCT01605370|Primary|Change in Inappropriate Left Ventricular Mass (LVM)|LVM will be measured by echocardiography exam. LVM is inappropriate when observed LVM (oLVM) exceeds predicted LVM (pLVM) by more than 28%, that is, 100×(oLVM/pLVM) >128%.|baseline, 6 months|Data were not collected for the single participant, so no analysis was performed.||||||
1366669|NCT01605292|Other Pre-specified|Pain Score|Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain.|2-8 hours after procedure||||units on a scale||Inter-Quartile Range|Median
1366670|NCT01605292|Post-Hoc|Failure of Radial Sheath Insertion With Original Randomized Technique||Immediate||||participants|||Number
1366671|NCT01605292|Post-Hoc|Crossover to Ultrasound Rescue Attempts After 5 Minutes|Patients randomized to palpation-guided access could have their procedure changed to ultrasound at operator discretion after 5 minutes of palpation-guided attempts.|5 minutes|Only patients randomized to palpation could potentially cross over to ultrasound technique.|||participants|||Number
1366672|NCT01605292|Other Pre-specified|Bleeding Complication|Any hematoma >2 cm or bleeding requiring intervention|After procedure (within 24 hours)||||participants|||Number
1366673|NCT01605292|Other Pre-specified|Difficult Access >= 5 Minutes|Access that requires >= 5 minutes from first attempt to sheath insertion|Immediate (within 30 minutes)||||participants|||Number
1366674|NCT01605292|Other Pre-specified|Difficult Access Procedures >= 5 Attempts|Difficult procedures were defined as either requiring >= 5 attempts|Immediately during procedure (within 30 min)||||participants|||Number
1366675|NCT01605292|Other Pre-specified|Radial Artery Spasm|Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation|Immediately during procedure (within 30 min)||||participants|||Number
1366676|NCT01605292|Secondary|First-pass Success Rate|Proportion of procedures achieving access on the first attempt|Immediate|Subgroup of patients with accurate number of attempts measured|||participants|||Number
1366679|NCT01605227|Other Pre-specified|Progression-free Survival (PFS)|The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration.|Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months|The Intent to Treat (ITT) population was used and include 1028 randomized subjects (682 cabozantinib, 346 prednisone) with a data cut off date of 07 July 2014.|||months||95% Confidence Interval|Median
1366680|NCT01605227|Secondary|Bone Scan Response (BSR)|BSR is defined as >=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.|BSR was measured at the end of Week 12 as determined by the IRF|Analysis was conducted on the ITT population (682 cabozantinib, 346 prednisone) for Bone Scan Response (BSR) at Week 12.|||percentage of participants||95% Confidence Interval|Number
1366681|NCT01605227|Primary|Overall Survival (OS)|The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.|OS was measured from the time of randomization until 614 events, approximately 24 months after study start|The Intent to Treat (ITT) population was used and included 1028 randomized subjects (682 cabozantinib, 346 prednisone).|||months||95% Confidence Interval|Median
1366682|NCT01605019|Secondary|Evaluate the Use of CoSeal for Its Ability to Reduce Micro Emboli During the LVAD Implant Procedure and Prevent Tissue Adhesions Following the Implantation of a LVAD|"During the LVAD implant surgery, TEE and Transcranial Doppler will be conducted before and after the LVAD implant/CoSeal™ administration to detect possible micro emboli in the left ventricle (TEE) and in the intra-cranial circulation (TCD).~• Intra-operative evaluation of surgical adhesions during LVAD explantation/heart transplant."|Participants will be followed for duration of hospital stay, typically average of 1-4 weeks at time of LVAD surgery & again at time of heart transplant surgery|Analysis not completed - study terminated due to funding pulled by sponsor||||||
1366683|NCT01605019|Primary|Number of Participants With Reduced Bleeding Following the Implantation of a LVAD|The Primary Objective of this prospective pilot study is to evaluate the use of CoSeal™ for its ability to reduce bleeding following the implantation of a LVAD. Total output amounts for each chest tube (CT) will be collected every 24 hours until all chest tubes are discontinued. Additionally, the total number of blood transfusions required during the hospitalization to implant the LVAD will be collected|Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks.|no analysis was performed on the 4 subjects enrolled in the study - they did not complete study.||||||
1366684|NCT01604941|Secondary|Number of Participants Classified as a Responder by Serum Ferritin|A responder was defined as a participant whose observed serum ferritin level at the measured time point was less than the baseline value. Serum ferritin levels were determined from serum biochemistry analyses.|8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
1366685|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas), and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
1366686|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas). Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
1366687|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures, and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
1366697|NCT01604850|Secondary|Percentage of Participants Achieving SVR24|"SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1366688|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
1366689|NCT01604941|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
1366690|NCT01604941|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were determined from serum biochemistry analyses. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||ng/mL||Standard Deviation|Mean
1366691|NCT01604941|Secondary|Change From Baseline in Cardiac T2* Relaxation Rate, an MRI Parameter Used to Estimate Cardiac Iron Load|The efficacy of SPD602 was assessed by estimating cardiac iron load. T2* data from cardiac MRI were collected by using standard procedures and used as an estimate of cardiac iron load. T2* is an MR relaxation parameter that is reported in milliseconds. Iron within a tissue decreases homogeneity of the magnetic field and shortens the T2* relaxation rate (Anderson, 2001). Low cardiac T2* values are associated with increased risk of heart failure (Kirk, 2009). A negative change from baseline in the T2* relaxation rate indicates that iron load increased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||milliseconds||Standard Deviation|Mean
1366692|NCT01604941|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
1366693|NCT01604941|Secondary|Change From Baseline in LIC as Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
1366694|NCT01604941|Primary|Change From Baseline in Liver Iron Concentration (LIC) as Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
1366695|NCT01604850|Secondary|Percentage of Participants With Viral Relapse|"Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|End of treatment to posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||participants|||Number
1366696|NCT01604850|Secondary|Percentage of Participants With Viral Breakthrough|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.~For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Up to 16 weeks|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1366858|NCT01603420|Secondary|Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events|Assessment will be performed using CTCAE v 4 criteria.|at 6 months||||incidences|||Number
1366698|NCT01604850|Secondary|Percentage of Participants Achieving SVR4|"SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 4|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1366699|NCT01604850|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug|Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.|Baseline to Week 16|The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||participants|||Number
1366700|NCT01604850|Primary|Percentage of Participants Achieving SVR12|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 12|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1366701|NCT01604772|Secondary|Incidence of Toxicities of Akt Inhibitor MK-2206|Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).|Time to first treatment to up to 30 days after completion of treatment|||||||
1366702|NCT01604772|Secondary|Overall Survival|Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.|Time of study entry to death due to any cause, assessed up to 3 years from registration|This endpoint has not been assessed yet.||||||
1366703|NCT01604772|Secondary|Median Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time of study entry to progression or death, up to 3 years after registration|Two patients were deemed ineligible and were not included in this endpoint.|||months||95% Confidence Interval|Median
1366704|NCT01604772|Primary|Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1|"Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Up to 32 weeks|Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible patients.|||percentage of patients||95% Confidence Interval|Number
1366705|NCT01604408|Secondary|Change From Baseline in Usual Gait Speed (uGS) at 4 Meters|Change from baseline to the 24-week endpoint in uGS is presented. Two attempts to walk a 4-meter distance were made. LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline uGS as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable uGS data.|||meters per second (m/s)||Standard Error|Least Squares Mean
1366706|NCT01604408|Secondary|Change From Baseline in Repeated Chair Stands (RCS) Time|Change from baseline to 24-week endpoint in RCS time is presented. In the RCS test, participants were asked to rise from a chair 5 times as fast as possible with their arms folded on their chest. Performance was measured in seconds, as the time from the initial seated position to the final standing position. LS means were calculated using an MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline RCS time as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable RCS time data.|||seconds||Standard Error|Least Squares Mean
1366707|NCT01604408|Secondary|Change From Baseline in Stair Climbing (StC) Time|Change from baseline to the 24-week endpoint in StC time is presented. StC time was assessed by measuring the fastest time achieved to climb 4 steps on a 4-step staircase (the test was performed 2 times). LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline StC score as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable StC time data.|||seconds||Standard Error|Least Squares Mean
1366708|NCT01604408|Primary|Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)|Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable aLBM data.|||kilograms (kg)||Standard Error|Least Squares Mean
1366709|NCT01604343|Secondary|Change From Baseline in EuroQol EQ-5D-3L Descriptive System|"The EQ-5D-3L Descriptive System comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received."|at Week 8, 16, 24, and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1366743|NCT01604278|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.|12 weeks|Safety Set: The safety set included all patients who received at least one dose of study drug whether or not they were randomized.|||Number of participants|||Number
1366710|NCT01604343|Secondary|Change From Baseline in EuroQol Health State Visual Analogue Scale (EQ VAS)|The EuroQol Health State Visual Analogue Scale (EQ VAS) records the respondent’s self-rated health on a vertical line, VAS where the endpoints are labeled as 0= ‘Worst imaginable health state’ and 100= ‘Best imaginable health state’. The EQ VAS can be used as a quantitative measure of health outcome as judged by the individual respondents. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 8, 16, 24, 36 and 52|Full analysis set was defined as all randomized participants. Here 'N'(number of participants analyzed): Evaluable for this outcome measure. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1366711|NCT01604343|Secondary|Change From Baseline in Total Scores of Work Limitations Questionnaire (WLQ) Week 8, 16, 24, 36 and 52|The Work Limitations Questionnaire (WLQ) was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 8, 16, 24, 36 and 52|Full analysis set was defined as all randomized participants. Here 'N'(number of participants analyzed): Evaluable for this outcome measure. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1366712|NCT01604343|Secondary|Percentage of Participants With Greater Than or Equal to 4-Point Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 8, 16, 24, 36 and 52|The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The questionnaire consists of 13 questions that assess a participant’s level of fatigue and tiredness over the last 7 days. Each question is graded on a 5-point scale (0 - 4); and accordingly, the total FACIT-Fatigue scores can range from 0 to 52, with lower score reflecting more fatigue and higher scores reflecting less fatigue. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 8, 16, 24, 36 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Percentage of Participants|||Number
1366713|NCT01604343|Secondary|Change From Baseline in Physical and Mental Component Summary Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 24 and 52|SF-36 questionnaire is health related quality of life (QOL) instrument with 36 questions with 8 multi-item scales (evaluated limitations in): physical functioning due to health problems; usual role activities due to physical health problems; Bodily pain; General mental health (psychological distress and well-being); usual role activities due to personal or emotional problems; social functioning due to physical or mental health problems; Vitality (energy and fatigue); General health perception. Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, summary scores, physical component score (PCS) and mental component score (MCS) will be derived. Scoring is derived based on algorithm developed in software provided by developer. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants were analyzed according to randomized treatment groups they were assigned regardless of treatments they actually received.|Baseline, Week 24 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1366714|NCT01604343|Secondary|Change From Baseline in the Duration of Morning Stiffness Through Week 52|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Here 'N'(number of participants analyzed): Evaluable for this outcome measure. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Minutes||Standard Deviation|Mean
1366715|NCT01604343|Secondary|Change From Baseline in Serum C-reactive Protein (CRP) Levels Through Week 52|Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Milligram per Deciliter||Standard Deviation|Mean
1366754|NCT01604265|Secondary|Change From Baseline in the Multiple Sclerosis Functional Composite Score at the End of Treatment (4 Weeks)|The Multiple Sclerosis Functional Composite test is a three-part, standardized, quantitative, assessment instrument for use in clinical studies. The three components of the test measure leg function/ambulation, arm/hand function, and cognitive function. An increase in score indicates an improvement (range -3 to +3).|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1367795|NCT01592708|Secondary|Post-discharge Vomiting||1 week post discharge|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.|||percentage of subjects with PDV|||Number
1366716|NCT01604343|Secondary|Change From Baseline in Van Der Heijde Modified Sharpe Score (vdH-S Score) by Reader at Weeks 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS (i.e., JE score + JSN score) of 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Weeks 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
1366717|NCT01604343|Secondary|Percentage of Participants With a Change of Less Than or Equal to 0 From Baseline in Van Der Heijde Modified Sharpe (vdH-S) Score at Weeks 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS of (i.e., erosion score + JSN score) 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Percentage of Participants|||Number
1366718|NCT01604343|Secondary|Percentage of Participants With Change From Baseline in Van Der Heijde Modified Sharpe Score (vdH-S Score) Greater Than Smallest Detectable Change (SDC) at Weeks 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S). JE is summary of erosion severity in 32 of hand and 12 of feet joints, scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) whereas the JSN is summary of severity of 30 of hand and 12 of feet joints, scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation). The SDC is smallest change in score that is considered to be assessed correctly based on limits of agreement (that is., above the measurement error). The SDC for change from baseline in vdH-S Score is determined as: SDC=1.96 * SD / (root 2 * root k), where SD is the standard deviation of the difference between 2 readers in change from baseline in vdH-S score; k is the number of readers. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Weeks 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Percentage of Participants|||Number
1366719|NCT01604343|Secondary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Sub-score by Region Hand or Feet and Type Erosion or JSN at Week 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS (i.e., erosion score + JSN score) of 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
1366720|NCT01604343|Secondary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Sub-score by Type of Damage (Erosion or JSN) at Week 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS (i.e., JE score + JSN score) of 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
1366903|NCT01602744|Primary|SF-12 Health Survey questionnaire-the Physical Component Summary (PCS)|Quality of life was assessed by the SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores:the Physical Component Summary (PCS) AND Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up||||units on a scale||Standard Deviation|Mean
1366721|NCT01604343|Secondary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Score at Week 24|vdH-S score is defined as a measurement of progression in structural damage. It is the sum of joint erosion (32 joints of the hands and 12 joints of the feet) score and joint space narrowing (JSN) (30 joints of the hands and 12 joints of the feet) score. The joint erosion assessment is scored according to the surface area involved, from 0 to 5, with 0 indicating no erosion and 5 indicating complete collapse of bone whereas the JSN assessment including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
1366722|NCT01604343|Secondary|Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Score of Less Than or Equal to 0.5|HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Percentage of Participants|||Number
1366723|NCT01604343|Secondary|Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 52|HAQ-DI response was defined as change of less than -0.22 from baseline in HAQ-DI score. The HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Percentage of Participants|||Number
1366724|NCT01604343|Secondary|Area Under the Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52|HAQ-DI has 20-question in 8 functional areas: dressing, arising, eating, walking, hygiene, reaching, gripping, and daily living activities, scored from 0=no difficulty to 3=inability to perform task in that area. Overall score computed as sum of domain score divided by number of domains answered. Total possible score range 0= least difficulty to 3= extreme difficulty. AUC of change from baseline in HAQ-DI score is AUC of change from baseline in HAQ-DI score versus time. AUC was calculated based on measurement (observed HAQ-DI score change from baseline) at scheduled visits using trapezoidal rule.Functional status was determined as cumulative measure of HAQ-DI over 1 year by using AUC of change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI means greater average improvement in physical function over time. Participants analyzed according to randomized treatment groups they were assigned, regardless of treatments they actually received.|Week 0 Through Week 24 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale*Day||Standard Deviation|Mean
1366725|NCT01604343|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 52|The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Negative change reflects an improvement and a positive change reflects a worsening. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1366755|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Anxiety at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall anxiety score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1367796|NCT01592708|Primary|Post-operative Vomiting||End of surgery to discharge from hospital||||percentage of subjects with POV|||Number
1366726|NCT01604343|Secondary|Percentage of Participants With Boolean-based American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 52|A participant was considered as having achieved the Boolean-based American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) remission at a visit if all of the following 4 criteria were met at that visit: Tender joint count (68 joints) less than or equal to (<=) 1; Swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); Patient’s Global Assessment of Disease Activity <=1 on a 0 (very well) to 10 (very poor) VAS. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to not achieving Boolean-based remission after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366727|NCT01604343|Secondary|Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 52|Participant having SDAI-based ACR/EULAR remission at a visit if SDAI score is of <= 3.3. SDAI derived by combining 5 disease assessments: tender joint (28), swollen joint (28) counts, participants global assessment of disease activity using VAS (scale ranges from 0 to 10 [0 =very well to 10 = very poor]), physicians global assessment of disease activity using VAS (scale ranges from 0 to 10 [0=no arthritis to 10=extremely active arthritis]) and CRP. 28 joints evaluated for swelling and tenderness are same set of 28 joints used in DAS28 includes shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of upper right and left extremities and knee joints of lower right and left extremities. Change from baseline in SDAI score measures change in disease activity, where negative change= improvement and positive change= worsening. Participants were analyzed according to randomized treatment groups they were assigned regardless of treatments actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to not achieving SDAI-based remission after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366728|NCT01604343|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 52|The CDAI score is a derived score of 4 components: tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1366729|NCT01604343|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score Through Week 52|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is from 0 to 86 with a lower score indicating less disease activity. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1366730|NCT01604343|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) (C-reactive Protein (CRP) Remission Through Week 52|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. The Disease Activity Index Score 28 (DAS28) C-reactive protein (CRP) remission is defined as a DAS28 (CRP) value of less than 2.6 at a visit. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to not achieving DAS28 remission after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366731|NCT01604343|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28) C-reactive Protein (CRP) Through Week 52|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
1367015|NCT01602224|Secondary|Overall Response Rate (ORR)|Overall Response Rate (ORR) is the percentage of participants that had a response.|Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)|All randomized participants who had a partial response or greater.|||percentage of participants|||Number
1366732|NCT01604343|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) C-reactive Protein (CRP) Response Through Week 52|DAS28 based on C-Reactive Protein (CRP), a statistically derived index combining tender joints (28), swollen joints (28), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both upper right extremity and upper left extremity as well as knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1. Participants were analyzed according to randomized treatment groups they were assigned to, regardless of treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366733|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 90 Response Through Week 52|An ACR 90 response is defined as >= 90 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 90% improvement in 3 of the following 5 assessments: Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366734|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 70 Response Through Week 52|An ACR 70 response is defined as >= 70 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 70% improvement in 3 of the following 5 assessments: Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366735|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response|An ACR 50 response is defined as >= 50 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366736|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response Through Week 52|An ACR 20 response is defined as >= 20 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 20% improvement in 3 of the following 5 assessments: Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Full analysis set included all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
1366752|NCT01604278|Primary|Trough Forced Expiratory Volume at 1 Second (FEV1)|Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
1366737|NCT01604343|Secondary|Percentage of Participants With Major Clinical Response (MCR) at Week 52|MCR- participant achieving ACR 70 response for 6 continuous months (24 weeks) in the study period (i.e., through Week 52). An ACR 70 response is defined as >= 70% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 70% improvement in 3 of the following 5 assessments Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (scale ranges from 0 to 10, [0=no arthritis to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (scale ranges from 0= no difficulty, to 3= inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders if meeting EE, LE or TF criteria prior to week 52 or having data missing.|||Percentage of Participants|||Number
1366738|NCT01604343|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) (C-reactive Protein (CRP) Remission at Week 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. The Disease Activity Index Score 28 (DAS28) C-reactive protein (CRP) remission is defined as a DAS28 (CRP) value of less than 2.6 at a visit. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 24|Full analysis set included all randomized participants. Participants were set to not achieving DAS28 remission if meeting EE or TF criteria prior to week 24 or having data missing.|||Percentage of Participants|||Number
1366739|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|An American College of Rheumatology (ACR) 50 response is defined as >= 50 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 24|Full analysis set included all randomized participants. Participants were set to non-responders if meeting EE or TF criteria prior to week 24 or having data missing.|||Percentage of Participants|||Number
1366740|NCT01604343|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.|||Units on Scale||Standard Deviation|Mean
1366741|NCT01604343|Primary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Score at Week 52|The van der Heijde-modified Sharpe (vdH-S) score is defined as a measurement of progression in structural damage. It is the sum of joint erosion (32 joints of the hands and 12 joints of the feet) score and joint space narrowing (JSN) (30 joints of the hands and 12 joints of the feet) score. The joint erosion assessment is scored according to the surface area involved, from 0 to 5, with 0 indicating no erosion and 5 indicating complete collapse of bone whereas the JSN assessment including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received. Here, EE= early escape.|Baseline, Week 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
1366742|NCT01604343|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16|ACR 20 response is greater than or equal to (>=) 20 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and >= 20% improvement in 3 of following 5 assessments:Participant’s assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant’s global assessment of disease activity by using VAS (scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale ranges from 0= no difficulty to 3= inability to perform a task in that area), and Serum C-reactive protein (CRP). Participants were analyzed according to randomized treatment groups they were assigned, regardless of treatments they actually received. Here, TF= treatment failure.|Week 16|Full analysis set included all randomized participants. Participants were set to non-responders if meeting TF criteria prior to week 16 or having data missing.|||Percentage of Participants|||Number
1366744|NCT01604278|Secondary|Change From Baseline in Mean Daily Total and Individual Symptom Scores|The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied. For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom. The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Score||Standard Error|Least Squares Mean
1366745|NCT01604278|Secondary|Transitional Dyspnea Index (TDI) Focal Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI). Analysis was done via mixed model. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of 1 is considered a minimal clinically important difference.|baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Score||Standard Error|Least Squares Mean
1366746|NCT01604278|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Number of puffs||Standard Error|Least Squares Mean
1366747|NCT01604278|Secondary|Inspiratory Capacity (IC) at Individual Time-points|Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
1366748|NCT01604278|Secondary|Forced Vital Capacity (FVC) at Individual Time-points|FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Day 29, Day 57 and Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
1366749|NCT01604278|Secondary|FEV1 at Individual Time-points|Centralized spirometry according to internationally accepted standards was used. FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|Day 1, Day 29, Day 57 and Days 84/85|Full Analysis Set|||Liters||Standard Error|Least Squares Mean
1366750|NCT01604278|Secondary|Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks|Centralized spirometry was used according to internationally accepted standards was used. Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect. If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
1366751|NCT01604278|Secondary|FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose|Centralized spirometry was used according to internationally accepted standards was used. The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time. Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated). Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
1366756|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Depression at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall depression score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366757|NCT01604265|Secondary|Change From Baseline in the Mean 0-100 mm Visual Analogue Scale Score for Intoxication Levels at the End of Treatment (4 Weeks)|Intoxication levels were recorded on a Visual Analogue Scale, where zero equated with “no intoxication” and 100 equated with “extreme intoxication”. A decrease in baseline score indicates a reduction in intoxication.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366758|NCT01604265|Secondary|Change From Baseline in the Mean Total Guy’s Neurological Disability Scale Score at the End of Treatment (4 Weeks)|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy’s Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366759|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment (4 Weeks)|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||number of words||Standard Deviation|Mean
1366760|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for the 'Paced Auditory Serial Addition Task' (PASAT) at the End of Treatment (Week 4)|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||percentage of correct answers||Standard Deviation|Mean
1366761|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment (Week 4)|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366762|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment (Week 4)|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Weeks 0 - 4|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366763|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment (Week 4)|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Baseline to end of study (0 - 4 weeks)|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366764|NCT01604265|Secondary|Change From Baseline in the Mean Neuropathic Pain Scale 0-10 Numerical Rating Scale Score at the End of Treatment (Week 4)|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = worst pain imaginable). A negative change from baseline indicates an improvement in pain.|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1368633|NCT01584388|Secondary|Sustained Disease Response|Decline of the IgG4-RD RI by at least two points and maintained for 12 months.|12 months||||Participants|||Count of Participants
1366765|NCT01604265|Secondary|Subject Global Impression of Change at Week 4|A 7-point Likert-type scale was used, with the question: ‘Please assess the improvement in overall condition since the start of the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at Week 4 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
1366766|NCT01604265|Secondary|Change From Baseline in the Mean 0-10 Numerical Rating Scale Sleep Score at the End of Treatment (4 Weeks)|Each day patients were asked to record in their subject diary, whether or not they were “woken due to nerve pain last night”, using a 0-10 Numerical Rating Scale sleep score where zero equated with “did not disrupt sleep” and 10 meant “completely disrupts sleep (unable to sleep due to pain)”. A decrease in score from baseline indicates an improvement.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366767|NCT01604265|Primary|Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)|"The average pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. A negative value indicates an improvement in pain score from baseline."|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1366768|NCT01604122|Primary|Caregiver Burden Items Assessment: Total Cost|Caregivers completed a series of questions related to the total cost spent on providing healthcare support to participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||dollars||Standard Deviation|Mean
1366769|NCT01604122|Primary|Caregiver Burden Items Assessment: Work Time Lost|Caregivers completed a series of questions related to the loss in their working time while providing care and support to the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hours||Full Range|Median
1366770|NCT01604122|Primary|Caregiver Burden Items Assessment: Number of Hours Per Week Spent in Care of the Participants With ATTR|Caregivers completed a series of questions related to the number of hours per week spent on providing care and support to the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hours per week||Full Range|Median
1366771|NCT01604122|Primary|Zarit Burden Interview: Subscale Scores|A questionnaire designed to evaluate aspects of caregiver burden in terms of personal and role strain associated with caregiving. Total score of ZBI scale ranges from 0-88 with higher scores indicating increased burden of care. Five subscale scores were also calculated: (1) Burden in the relationship (consist of 6-items, ranging from 0 to 24 where higher scores indicating increased burden in relationship); (2) Emotional well-being (consisting of 7-items, ranging from 0 to 28 where higher scores indicating worse condition; (3) Social and family life (consisting of 4-items, ranging from 0 to 16 where higher scores indicating worse life condition); (4) Finances (consisting of a single item, scored from 0 to 4 where higher scores indicating worse financial condition); and (5) Loss of control over one's life (consisting of 4-items, ranging from 0 to 16 where higher scores indicating worse control over life).|Baseline (Day 1)|All participants who were included in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category.|||units on a scale||Standard Deviation|Mean
1366772|NCT01604122|Primary|Zarit Burden Interview (ZBI): Total Scores|"ZBI was a 22-item questionnaire designed to evaluate five broad aspects of caregiver burden in terms of personal and role strain associated with caregiving. Five broad aspects were: burden in the relationship, emotional well-being, social and family life, finances, loss of control over one's life. Each item rated on a 5 point scale anchored at 0 for never and 4 for nearly always. Total score ranges from 0-88 with higher scores indicating increased burden of care."|Baseline (Day 1)|All participants who were included in the study and completed the survey.|||units on a scale||Standard Deviation|Mean
1366773|NCT01604122|Primary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores|KCCQ was a 23-item participant-completed questionnaire that assessed health status and health-related quality of life (HRQoL) in participants with heart failure. It was quantified in to following 10 summary scores: physical limitation, symptom frequency, symptom severity, and symptom stability, total symptoms, quality of life, social interference, self-efficacy, overall summary and clinical summary. Each summary score was scaled to range from 0 (minimum) to 100 (maximum), with higher scores representing greater disability. Total score ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366774|NCT01604122|Primary|Norfolk Quality of Life-Diabetic Neuropathy Total Quality of Life: Subscale Scores|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of neuropathy on the quality of life of participants diagnosed with ATTR. It was summarized in 5 domains: (1) Activities of daily living (score ranges from 0 to 20, where higher score=worse quality of life); (2) Large fiber neuropathy/physical functioning (score ranges from -2 to 58, where higher score=worse condition); (3) Small fiber neuropathy (score ranges from 0 to 16, where higher score=worse condition); (4) Autonomic neuropathy (score ranges from 0 to 12, where higher score=worse condition) and (5) Symptoms (score ranges from 0 to 32, where higher score=less symptoms of disease). Total possible score range= -2 to 138, where higher score=worse quality of life. This outcome measure was analyzed only for the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for specific category.|||units on a scale||Standard Deviation|Mean
1366775|NCT01604122|Primary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL): Total Scores|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of neuropathy on the quality of life of participants diagnosed with ATTR. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: activities of daily living, large fiber neuropathy/physical functioning, small fiber neuropathy, autonomic neuropathy, and symptoms. TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life. This outcome measure was planned to be analyzed only for the reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366776|NCT01604122|Primary|Participants Pain Score|Participants diagnosed with ATTR rated their pain due to the health condition based on 3 items: pain right now, average pain in the past week, and worst pain in the past week prior to baseline visit. All 3 items were rated on an 11-point numeric rating scale ranging from 0=none to 10=severe pain, where higher scores indicated severe pain.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366777|NCT01604122|Primary|Healthcare Resource Use Survey: Out-of-Pocket Costs|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (expenditure on nutritional supplements, non-prescription medications and travel to receive medical care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category.|||dollars||Full Range|Median
1366778|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Symptomatic Treatment Visits|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs. Number of visits of participants (diagnosed with ATTR) who visited non-medical practitioners (nutrition consultant/dietician, chiropractor, acupuncturist, massage therapist, occupational therapist or other than these) for symptomatic treatments were reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for specific category.|||symptomatic treatment visits||Standard Deviation|Mean
1366779|NCT01604122|Primary|Healthcare and Resource Use Survey: Symptomatic Treatment of Participants|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs. Number of participants (diagnosed with ATTR) who visited non-medical practitioners (nutrition consultant/dietician, chiropractor, acupuncturist, massage therapist, occupational therapist or other than these) for symptomatic treatments were reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
1366780|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Emergency Care Visits|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||emergency care visits||Standard Deviation|Mean
1366781|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Hospitalizations|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hospitalization visits||Standard Deviation|Mean
1366782|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Outpatient Visits to Healthcare Providers|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category for each arm respectively.|||outpatient visits||Standard Deviation|Mean
1366783|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Activity Impairment|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asks about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366792|NCT01604122|Primary|Disease Characteristics of Participants: Number of Participants With Family History of ATTR|Family history of participants diagnosed with ATTR was assessed to determine whether family history of ATTR was a significant risk factor for ATTR or not. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
1366784|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Overall Work Impairment|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asked about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366785|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Impairment While Working|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asks about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366786|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version (WPAI-SH): Percent of Work Time Missed|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asked about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Percentage of work time missed of participants were recorded and reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||percentage of work time missed||Full Range|Median
1366787|NCT01604122|Primary|Euro Quality of Life (EQ-5D-3L)- Visual Analog Scale (VAS) Score|EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366788|NCT01604122|Primary|Euro Quality of Life (EQ-5D-3L)- Health State Profile Utility Score|EQ-5D-3L: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366789|NCT01604122|Primary|Hospital Anxiety and Depression Scale (HADS): Depression and Anxiety Subscale Scores|HADS: participant rated 14-item questionnaire with 2 subscales; HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D). HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for each subscale; higher score indicating greater severity of anxiety and depression symptoms.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1366790|NCT01604122|Primary|12-Item Short-Form Health Survey (SF-12) Scores|SF-12 was a patient reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific component for each arm respectively.|||units on a scale||Standard Deviation|Mean
1366791|NCT01604122|Primary|Disease Characteristics of Participants: Mobility Status|Mobility, i.e., ability to walk was assessed as a part of loss of functioning in the participants diagnosed with ATTR. In this outcome, number of participants with their different mobility status along with the use of mobility aids (able to walk normally, some problems with feet but able to walk without difficulty, some difficulty walking but can walk without help, confined to bed all the time, need 1 cane or crutch to walk, need 2 canes/crutches or a walker to walk) were reported.|Baseline (Day 1)|All participants who were included in the study and completed the survey.|||participants|||Number
1366793|NCT01604122|Primary|Disease Characteristics of Participants: Liver Transplantation Status|TTR protein is primarily synthesized in the liver. Liver transplantation was considered as one of the measure to eliminate the main source of variant TTR. In the study, participants who were diagnosed with ATTR were asked for their liver transplantation status (whether they had transplantation or not). In this outcome measure, number of participants with liver transplant status were reported. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
1366794|NCT01604122|Primary|Disease Characteristics of Participants: Mutation Type|Genetic mutation leads to misfolding of protein transthyretin (TTR) which results in ATTR. In this outcome, number of participants with each type of resulted mutation type (Val30Met, wild type TTR, Phe64Leu, Ser77Tyr, Thr60Ala or other than these) were reported. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
1366795|NCT01604122|Primary|Disease Characteristics of Participants: Disease Duration|Duration of disease was defined as the time from diagnosis of disease until baseline visit. This outcome measure was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||years||Full Range|Median
1366796|NCT01604122|Primary|Demographical Characteristics of Participants|Main characteristics included were education level and employment status which were asked from all participants and caregivers. Type of job (full-time, part-time) was asked only from those participants and caregivers who provided their employment status as employed. Those who were unemployed reported their cause of unemployment, whether it was due to ATTR or not.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category for each arm respectively.|||participants|||Number
1366797|NCT01604109|Secondary|Quantitative Light-induced Fluorescence (QLF) Parameters|percent fluorescence loss, lesion area, lesion volume|one calender year|||||||
1366798|NCT01604109|Primary|the Mean Number of Enamel Carious Lesion|tooth surface that was classified as ICDAS code 1-3|one calender year||||Surfaces||Standard Deviation|Mean
1366799|NCT01603940|Secondary|Vascular Stiffness by Augmentation Index|Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.|12 weeks||||percentage of augmentation pressure||Inter-Quartile Range|Median
1366800|NCT01603940|Secondary|Diastolic Blood Pressure|Compare both group effects on diastolic blood pressure.|12 weeks||||mmHg||Inter-Quartile Range|Median
1366801|NCT01603940|Secondary|Systolic Blood Pressure|Compare both groups effects on systolic blood pressure.|12 weeks||||mmHg||Inter-Quartile Range|Median
1366802|NCT01603940|Secondary|Vascular Stiffness|Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).|12 weeks.||||m/s||Inter-Quartile Range|Median
1366803|NCT01603940|Primary|Endothelial Function|Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.|12 weeks||||percentage of maximal vasodilation||Inter-Quartile Range|Median
1366804|NCT01603875|Secondary|Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.|"There are five injections, on day 0, 7, 28, 360 and 363.~The side effects will be record in number and percentage."|up to 7 days after each injection|||||||
1366805|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 374||||International unit per ml||Full Range|Geometric Mean
1366806|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 360||||International unit per ml||Full Range|Geometric Mean
1366807|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 42||||International unit per ml||Full Range|Geometric Mean
1366808|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 28||||International unit per ml||Full Range|Geometric Mean
1366809|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 0||||International unit per ml||Full Range|Geometric Mean
1367029|NCT01602198|Primary|Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)||baseline and 6 months|Trial was terminated prematurely after enrollment of only 1 participant. Sample size is insufficient for BOLD response analysis.||||||
1366810|NCT01603628|Secondary|Change From Baseline in Severity of Spasticity of the Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)|The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. The investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2–R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between R2 and R1 range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived. An Analysis of Covariance (ANCOVA) model was used for analysis.|Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis at the given time-point.|||degrees||Standard Error|Least Squares Mean
1366811|NCT01603628|Secondary|Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale|Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An Analysis of Covariance (ANCOVA) model was used for analysis.|Weeks 8 and 12|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
1366812|NCT01603628|Primary|Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6|The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant’s clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis.|Weeks 4 and 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1366813|NCT01603628|Primary|Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6|The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 4 and 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1366814|NCT01603602|Secondary|Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)|The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and a fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. At each visit, the investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2 – R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between slow (R2) and fast (R1) range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived.|Baseline (Day 1) to Week 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||degrees||Standard Error|Least Squares Mean
1366815|NCT01603602|Secondary|Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale|Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An ANCOVA model was used for analysis.|Week 8 and 12|Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
1366823|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366816|NCT01603602|Secondary|Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6|The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the finger flexor muscle group by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. An Analysis of Covariance (ANCOVA) model was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 4 and 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
1366817|NCT01603602|Primary|Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6|The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant’s clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A MMRM model was used for analysis.|Weeks 4 and 6|Participants from the m ITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
1366818|NCT01603602|Primary|Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6|The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 4 and 6|Participants from the Modified Intent-to treat (mITT) population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1366819|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366820|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
1366821|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366822|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
1366904|NCT01602744|Secondary|Pharmacoeconomics Analysis-Costs of Medication|The costs on medications in the geriatric hospital before and after intervention e.g. pharmaeconomic analysis of the intervention. Costs of medications were calculated in New Israeli shekels per month and taken from the Ministry of Health's medication price list.|Outcome measures were assessed at the end of the 12 month follow up||||New Israeli shekels per month||Standard Deviation|Mean
1366824|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||Subjects|||Number
1366825|NCT01603459|Secondary|Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366826|NCT01603459|Secondary|EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject’s health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
1366827|NCT01603459|Secondary|Global Assessment of Efficacy Scores|Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
1366828|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit.|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366829|NCT01603459|Primary|Investigator’s Global Assessment of Tolerability in Subjects|A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Up to Week 48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
1366830|NCT01603459|Primary|Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication|Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.|From baseline to week 36-48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
1366831|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366832|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366833|NCT01603459|Secondary|Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366842|NCT01603459|Secondary|Resistance to Passive Movement Scale (REPAS) Scores of Treated Side|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366834|NCT01603459|Secondary|Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively|Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk & Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment.|From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366835|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366836|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366837|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366838|NCT01603459|Secondary|Functional Ambulation Classification (FAC) Scale Scores|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366839|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 12-16, 24-32 and 36-48|The full analysis set is the subset of all subjects who were exposed to study medication at least once.|||units on a scale||Standard Deviation|Mean
1366840|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 4, 16-20 and 28-36|The full analysis set is the subset of all subjects who were exposed to study medication at least once.|||units on a scale||Standard Deviation|Mean
1366841|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366855|NCT01603420|Secondary|Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination||||||
1366856|NCT01603420|Secondary|Assessment of Total Number of Local/Distant Failures|The total number of local/distant failures will be assessed.|at time of study closure (22 months)||||participants|||Number
1366843|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366844|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366845|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366846|NCT01603459|Secondary|Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern in the respective injection cycle.|||units on a scale||Standard Deviation|Mean
1366847|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366848|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366849|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366850|NCT01603459|Secondary|Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|The full analysis set (FAS) is the subset of all subjects who were exposed to study medication at least once. Only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
1366851|NCT01603420|Secondary|Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination||||||
1366852|NCT01603420|Secondary|Assessment of Total Number of Biochemical Failure Events|The number of biochemical failure events will be assessed on both arms.|at study closure (22 months)||||participants|||Number
1366853|NCT01603420|Secondary|Assessment of Total Number of Survival Events With Comparison of Group Arms|The number of deaths in both arms will be assessed.|at study closure (22 months)||||participants|||Number
1366854|NCT01603420|Secondary|Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.|The total number of subjects with salvage androgen deprivation use will be assessed.|At study closure (22 months)||||participants|||Number
1368634|NCT01584388|Secondary|Disease Response at 6 Months|Decline of IgG4-RD Responder Index by at least two points for at least 6 months|6 months||||Participants|||Count of Participants
1366859|NCT01603420|Primary|Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.|"The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation.~This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years|This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.||||||
1366860|NCT01603420|Primary|Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.|"Assessment will be performed using CTCAE v4 criteria.~This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|2 years|This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).|||events|||Number
1366861|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm|"This endpoint will be examined if decision is made to not move forward with phase 3 study.~This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years|||||||
1366862|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm|"Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen [PSA] > = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation.~This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.|||failure events|||Number
1366863|NCT01603394|Secondary|Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.|The pain-related sleep interference item rating scale is scored on an 11-point numeric rating scale (NRS-Sleep). It is self-administered by the participant in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366864|NCT01603394|Secondary|Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.|The Short-Form 12 Health Survey (SF-12v2) is a self-administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. Higher scores indicate a better health-related quality of life.|Visit 2 (Week 0), and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366865|NCT01603394|Secondary|Pain NRS Score; 1 Week Recall Period.|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|1 Week|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366866|NCT01603394|Secondary|Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.|The PCS is a 13-item self report instrument and requires a Grade 6 reading level and has been translated into 12 languages. It instructs participants to reflect on past experience of pain and indicate their experience using a 5-point scale. The PCS was designed for research on catastrophizing and pain experience. Catastrophizing is associated with heightened pain and is “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.” It is a multidimensional construct compromising elements of rumination, magnification, and helplessness and its factor structure has been replicated. It has a total score and three subscale scores (score range of 0-52).|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366867|NCT01603394|Secondary|Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.|The Brief Pain Inventory-Short Form (BPI-sf) consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11-point scale from 0 (no pain) to 10 (worst pain possible).|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366868|NCT01603394|Secondary|Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination.|The PHQ-8 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The PHQ-8 is a validated subset of the PHQ-9, which comprises the first 8 items of the measure. The GAD-7 is a 7-item questionnaire that assesses anxiety. Participants respond as to how each item applies to them on a 4 point response scale. The higher the score, the more severe the anxiety.|Screening, Visit 2 (Week 0) and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366869|NCT01603394|Secondary|Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366870|NCT01603394|Secondary|Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.|The daily pain diary consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants describe their pain during the previous 24 hours by choosing the appropriate number between 0 and 10. Self-assessment is performed daily at bedtime on a telephone via interactive voice response system (IVRS). The endpoint mean pain score is defined as the mean of the last 7 daily diary pain ratings while taking study medication in the open-label phase. Daily pain IVRS diaries were completed daily at bedtime from Visit 1 (Screening) through Visit 7/Early Termination. Participants were asked to complete their first IVRS daily at bedtime on the morning after Visit 1.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366871|NCT01603394|Secondary|Patient Global Impression of Change (PGIC) at Week 6/Early Termination.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366872|NCT01603394|Secondary|Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline. Then for each of the above phenotypes the distribution of the pregabalin responders (using 30% and 50%) were to be compared.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366873|NCT01603394|Secondary|Neuropathic Pain Symptom Inventory (NPSI) at All Visits.|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|All visits|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366874|NCT01603394|Primary|Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
1366875|NCT01603277|Secondary|To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments||Week 24|||||||
1366876|NCT01603277|Secondary|To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)||Week 24|||||||
1366877|NCT01603277|Secondary|To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate||Week 24|||||||
1366878|NCT01603277|Primary|Change in Percent Predicted FEV1 at Week 24||Baseline to Week 24||||Percent||Standard Deviation|Mean
1366879|NCT01603121|Secondary|Evaluation of Early Efficacy of Study Drug|Blood draws will be performed at predetermined time points during and after the infusions in order to measure serum cytokine and chemokine concentrations, as well as to measure plasma STAT 4 and phosphorylated STAT 4 (markers of lisofylline efficacy).|24 hours|||||||
1366880|NCT01603121|Secondary|Study Drug Bioavailability After Subcutaneous and Intravenous Infusion|Blood will be collected for determination of lisofylline concentrations at various predetermined time points during the infusions, and 10 and 24 hours following infusion completion. This will help to determine if subcutaneous infusion over 10 hours results in similar lisofylline plasma concentrations as with intravenous infusion.|24 hours|||||||
1366881|NCT01603121|Primary|Safety and Tolerability of Study Drug|"Subjects will be monitored for adverse events both during and after the study drug infusion and will undergo physical examinations, electrocardiograms and clinical safety laboratory tests.~Study staff will contact subjects within 5 days after each dosing period and approximately 30 days after the 2nd dosing period, to review laboratory results and to ask the subject about any changes in health that they have experienced. Should the subject require an in-person evaluation, this will be arranged with the principal or sub-investigator promptly."|1 month|||||||
1366882|NCT01603082|Secondary|Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|0.5 hours, end of PCI, and 8 hours after the loading dose|PD Analysis Set. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.|||PRU||Standard Deviation|Mean
1366883|NCT01603082|Primary|Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.|||PRU||Standard Deviation|Mean
1366905|NCT01602744|Primary|Quality of Life- Mental Component Summaty (MCS)|Quality of life will be measured by MOS SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores: The Physical Component Summary(PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up||||units on a scale||Standard Deviation|Mean
1366906|NCT01602731|Primary|Feasibility of AMDD to Improve Medication Adherence Via Completion Rate|Rate that patient population completed set-up of AMDD was evaluated quantitatively.|4 months|Of 45 patients who started the study, 24 patients met the predetermined criteria for AMDD. Though all of the patients had agreed to set up the AMDD in their home, only 15 out of 24 ended up completing the setup in their home.|||participants|||Number
1366884|NCT01603056|Secondary|The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Asthma symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily asthma medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Medication score)||Standard Deviation|Mean
1366885|NCT01603056|Secondary|The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months’ RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better.|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(AQLQ score)||Standard Deviation|Mean
1366886|NCT01603056|Secondary|The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Rhinitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily Rhinitis medication score range from 0 to 30. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Medication score)||Standard Deviation|Mean
1366887|NCT01603056|Secondary|Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.|Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated.|Visit 9 date, Week 52|The analysis was performed in the Full Analysis Set.|||participants|||Number
1366888|NCT01603056|Secondary|The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|"The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52).~The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better."|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (RQLQ score)||Standard Deviation|Mean
1366889|NCT01603056|Secondary|The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated.|"The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question ‘How have your nasal complaints been today?’ from 0 = no symptoms to 10 = severe symptoms.~The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52)."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (VAS Score)||Standard Deviation|Mean
1366890|NCT01603056|Secondary|Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.|A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days.|Total study year|The analysis was performed in the Full Analysis Set.|||Percentage of healthy days||Standard Deviation|Mean
1366891|NCT01603056|Secondary|The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 4 symptoms as follows: Cough, Wheeze, Chest tightness/shortness of breath (dyspnoea), Exercise induced symptoms. The 4 symptom scores were summed to obtain the asthma symptoms score with range 0(best) to 12(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Symptom score)||Standard Deviation|Mean
1366907|NCT01602731|Secondary|Efficacy of AMDD to Improve Medication Adherence|Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD|30-day pill count before the use of AMDD and with AMDD||||percentage of adherence||Full Range|Mean
1367049|NCT01601821|Secondary|Percentage of Participants Who Survived|Survival defined as participants living with or without a functioning graft.|Month 12|PP3 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of death.|||percentage of participants|||Number
1366892|NCT01603056|Secondary|The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 2 symptoms as follows: Gritty feeling/red/itchy eyes, Watery eyes. The 2 symptom scores were summed to obtain the conjunctivitis symptoms score with range 0(best) to 6(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Symptom score)||Standard Deviation|Mean
1366893|NCT01603056|Secondary|The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 4 symptoms are as follows: Runny nose, Blocked nose, Sneezing, Itchy nose. The 4 symptom scores were summed to obtain the rhinitis symptoms score with range 0(best) to 12(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (Symptom score)||Standard Deviation|Mean
1366894|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (Medication Score)||Standard Deviation|Mean
1366895|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms.~The six symptoms are classified in 2 groups as follows:~Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months’ end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (Symptom Score)||Standard Deviation|Mean
1366896|NCT01603043|Secondary|Mean Change From Baseline in BCVA at Month 12|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), Month 12|||||||
1366897|NCT01603043|Secondary|Yearly GA Lesion Size Growth Rate|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), up to Month 12|||||||
1366898|NCT01603043|Primary|Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Day 0 (injection visit), Month 12|||||||
1366899|NCT01602965|Primary|Weight Loss|The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg. Height is measured by a fixed stadiometer, without shoes, to the nearest 0.5 cm.|Percent Change in weight loss at one year||||percentage of weight loss||Standard Deviation|Mean
1366900|NCT01602744|Primary|Functional Independence Measure (FIM)|Functioning was assessed by the FIM score. The FIM rates 18 activities of daily living on a 7 point scale ranging from fully dependent (=1) to independent (=7). A maximum score of 126 indicates functional independence and the lowest score of 18 indicates functional dependence.|Outcome measures were assessed at the end of the 12 month follow up||||units on a scale||Standard Deviation|Mean
1366901|NCT01602744|Primary|Hospitalizations|The average number of hospitalizations per year.|Outcome measures were assessed at the end of the 12 month follow up||||Number of hospitalizations per year||Standard Deviation|Mean
1366902|NCT01602744|Primary|Falls|Average number of falls per year.|At the end of the 12 month follow up||||Number of falls per year||Standard Deviation|Mean
1367992|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with mutant huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population|||ratio||Standard Deviation|Mean
1366908|NCT01602562|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1366909|NCT01602562|Secondary|Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35|Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Beats per minute||Standard Deviation|Mean
1366910|NCT01602562|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
1366911|NCT01602562|Secondary|Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||ratio||Standard Deviation|Mean
1366912|NCT01602562|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category.|Screening (SCR), Day 14, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1366913|NCT01602562|Secondary|Mean Hemoglobin Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1366914|NCT01602562|Secondary|Mean Red Blood Cell Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||tera (10^12) per liter (TI/L)||Standard Deviation|Mean
1366915|NCT01602562|Secondary|Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
1366916|NCT01602562|Secondary|Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Percentage of cells in blood||Standard Deviation|Mean
1366917|NCT01602562|Secondary|Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1368357|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||ng/dL||Standard Deviation|Mean
1366918|NCT01602562|Secondary|Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1366919|NCT01602562|Secondary|Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1366920|NCT01602562|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1366921|NCT01602562|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Safety Population: All participants who received VACV more than once.|||Participants|||Number
1366922|NCT01602562|Primary|Number of Participants With a Herpes Simplex Virus (HSV) Infection|Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Full Analysis Set (FAS): all participants who were given VACV more than once and who could provide data evaluable with respect to the occurrence of HSV infection.|||Participants|||Number
1366923|NCT01602549|Secondary|GSK962040 Tmax at Day1 and Day 8|GSK962040 tmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Hours||Full Range|Median
1366924|NCT01602549|Secondary|GSK962040 Cmax at Day1 and Day 8|GSK962040 Cmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
1366925|NCT01602549|Secondary|GSK962040 Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) at Day 1|GSK962040 %AUCex was derived from GSK962040 plasma concentration-time data. %AUCex is the percentage of the AUC(0-inf) extrapolated from the last PK sample drawn to infinity. This parameter is only reported in conjunction with single-dose AUC(0-inf). Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure.|Day 1|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1366926|NCT01602549|Secondary|GSK962040 Area Under the Plasma Concentration-time Curve From Zero to 5.5 Hours (AUC[0-5.5] and Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC[0-inf]) at Days 1 and 8|GSK AUC(0-5.5) and AUC(0-inf) were derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure. Data for AUC(0-inf) was analyzed and was only available for Day 1 and not for Day 8.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms.hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
1366927|NCT01602549|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, is associated with liver injury and impaired liver function, or are serious events as per the medical or scientific judgment.|From the start of study medication until Follow-up (up to Day 25)|All Subjects Population|||Participants|||Number
1366928|NCT01602549|Secondary|Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8|RET measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Tera (10^12) cells per liter||Standard Deviation|Mean
1366929|NCT01602549|Secondary|Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8|RBC and WBC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Giga (10^9) cells per liter||Standard Deviation|Mean
1366930|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8|MCV measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Femtoliters||Standard Deviation|Mean
1366931|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8|MCH measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Picograms||Standard Deviation|Mean
1366932|NCT01602549|Secondary|Change From Baseline in Hematocrit at Day 4 and Day 8|Hematocrit measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||proportion of 1||Standard Deviation|Mean
1366933|NCT01602549|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8|Hemoglobin and MCHC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Grams per liter||Standard Deviation|Mean
1366934|NCT01602549|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8|Basophils, eosinophils, lymphocytes, monocytes, total ANC, and PC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Giga (10^9) cells per liter||Standard Deviation|Mean
1366935|NCT01602549|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content (CO2)/Bicarbonate (BC), Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN), and Uric Acid (UA) at Day 4 and Day 8|Calcium, chloride, CO2/BC, glucose, potassium, sodium, urea/BUN, and UA measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Millimoles per liter||Standard Deviation|Mean
1366936|NCT01602549|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) at Day 4 and Day 8|ALP, ALT, AST, and GGT measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||International units per liter||Standard Deviation|Mean
1366937|NCT01602549|Secondary|Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8|ALB and TP measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Grams per liter||Standard Deviation|Mean
1366938|NCT01602549|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. ECG findings were categorized as normal, abnormal - not clinically significant, and abnormal - clinically significant (CS), based on interpretation by the site.|Day 1 and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Participants|||Number
1366939|NCT01602549|Secondary|Change From Baseline in Heart Rate at Day 1 and Day 8|Heart rate measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Beats per minute||Standard Deviation|Mean
1366940|NCT01602549|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8|Blood pressure measurements were taken at pre-dose and at 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population (ASP): all participants who received >=1 dose of study medication. Participants with available data (n=X, X in category titles) were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1366941|NCT01602549|Secondary|Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|Various formulations of L-DOPA were utilized by participants for the treatment of Parkinson’s Disease. The total daily L-DOPA equivalent dose was calculated as the sum of all L-DOPA equivalent doses for each L-DOPA-containing drug taken on the same day.|Baseline and Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Milligrams||Standard Deviation|Mean
1367144|NCT01600586|Primary|Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5)|Feeding rate when nippling was calculated by dividing the number of cc of nippled nutrition by time for consumption. This data was recorded at two time points: pre and post intervention|Day 0, and Day 5||||mL/min||Inter-Quartile Range|Mean
1366942|NCT01602549|Secondary|Number of Times a Participant Could Alternatively Tap Two Counter Keys 30 Centimeters Apart in 1 Minute (Min) at Baseline, Day1, Day 8, and Follow-up|Participants were asked to alternatively tap two keys 30 centimeters apart in 1 minute in two trials with the most affected hand or the dominant hand in symmetric disease. The finger tapping was scored manually by the study staff. The finger-tapping assessment was repeated at eight separate time points (pre-dose, 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, and 240 min post-dose) at each visit (Baseline, Day 1, and Day 8). At each time point, the mean of the two assessments was calculated.|Baseline, Day 1, and Day 8 at pre-dose and 0, 30, 60, 90, 120, 180, and 240 minutes post-dose; Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Finger taps per minute||Standard Deviation|Mean
1366943|NCT01602549|Secondary|"Period Mean Amount of Hours Spent “ON,” “ON” Without Dyskinesia, ON With Non-troublesome Dyskinesia, ON With Troublesome Dyskinesia, and “OFF” at Baseline and During the Treatment Period (Days 1-8), Week 1 of Follow-up, and Week 2 of Follow-up"|"Participants were provided with the ON/OFF diary to capture details of the amount of awake time spent on/off of PD symptoms, and were asked to complete the diary daily. Participants checked the box most appropriate for their dominant motor state in the preceding 30-minute period. The catergories included: ON (including “ON without dyskinesia” and “ON with non-troublesome dyskinesia), ON with troublesome dyskinesia (TD), and OFF. For Baseline, data were collected for 2 days prior to Day 1, and the mean value of the 2 days was used."|Baseline, Days 1-8, Week 1 of Follow-up (Days 6 and 7 of Follow-up; up to Day 16), and Week 2 of Follow-up (Days 13 and 14 of Follow-up; up to Day 23)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||hours||Standard Deviation|Mean
1366944|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Scores at Baseline, Day 1, and Day 8 (Pre-dose; 120, 180, and 240 Minutes Post-dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-dose and 120, 180, and 240 minutes (min) post-dose (PD); Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1366945|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-levodopa dose|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1366946|NCT01602549|Secondary|Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8|Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 8, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Minutes||Standard Deviation|Mean
1366947|NCT01602549|Primary|L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8|L-DOPA t1/2 was derived from L-DOPA plasma concentration-time data. This endpoint was not assessed because there were insufficient L-DOPA data/profiles to calculate this parameter.|Baseline, Day 1, and Day 8|||||||
1366948|NCT01602549|Primary|L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8|L-DOPA Tmax was derived from L-DOPA plasma concentration-time data.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Hours||Full Range|Median
1366949|NCT01602549|Primary|Dose-normalized L-DOPA Cmax at Day 1 and Day 8|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms/milliliter/milligram||Standard Error|Least Squares Mean
1366950|NCT01602549|Primary|Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data.|Baseline|PD/Efficacy Population. Only those participants available at the specified time point were analyzed.|||Nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1367114|NCT01601132|Primary|Apparent Total Body Clearance (CL/F) of Theophylline|Apparent total body clearance after oral administration, calculated as Dose /(AUC0-∞).|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||liters/hour||Standard Deviation|Mean
1366951|NCT01602549|Primary|Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios (GSK962040 50 mg: Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa pharmacokinetic (PK) parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. AUC is a measure of levodopa exposure|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms*hour/milliliter/milligram||Standard Error|Least Squares Mean
1366952|NCT01602549|Primary|Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. AUC is a measure of levodopa exposure.|Baseline|Pharmacodynamic (PD)/Efficacy Population: participants receiving >=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed.|||Nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1366953|NCT01602510|Secondary|Change From Baseline in Body Weight|Participant’s body weight was measured on Weeks 0, 4, 8, 12, 16, 20, 24, 32 and 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline score, treatment and baseline body weight. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The baseline value was defined as the last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks.|RD Full Analysis Population. Only those par. with available data at indicated time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
1366954|NCT01602510|Secondary|Change From Baseline of Global Assessment Scale (GAS) Total Score|For GAS, investigators rated par. for lowest level of functioning during the previous week. The scale has a 10 score categories: 1-10, 11-20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, 91-100, using intermediary levels when appropriate (from 100 to 1, Lower is worse.). Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and GAS total BL score. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The BL value was defined as the last non-missing values at or prior to the randomization. The change from BL at the time point of interest was calculated by subtracting the BL values from the individual post-BL values. If either the BL or post-BL value was missing, the change from BL was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population|||Score on a scale||Standard Error|Least Squares Mean
1366955|NCT01602510|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS consists of 11 items: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech, Language/Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance, and Insight. Investigators rated par. from 0 to 4 (or 8) for each of these items. Total score is the sum of all subscales, from 0 to 60 (higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and YMRS total BL score. In LOCF datasets, the last non-missing OT score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. BL value was defined as the last non-missing values at or prior to the randomization. Change from BL at the time point of interest was calculated by subtracting BL value from the individual post-BL value. If either the BL or post-BL value was missing, change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population|||Score on a scale||Standard Error|Least Squares Mean
1366956|NCT01602510|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAMD)|HAMD consists of 17 items: depressed mood, feelings of guilt, suicide, insomnia-early, middle, late, work and activities, retardation, agitation, anxiety psychic, anxiety somatic, somatic symptoms gastro-intestinal, general somatic symptoms, hypochondriasis, loss of weight, and insight. Investigators rated par. from 0 to 4 (or 2) for these items. Total score is sum of all subscales (0 to 52, higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline (BL) score, treatment and HAMD total BL score. The last non-missing OT score prior to TIME was carried forward to estimate missing data points for remaining study visits of the treatment period. BL value was defined as the last non-missing value at or prior to the randomization. Change from BL was calculated by subtracting BL from the specific post-BL value. If BL or post-BL value was missing, the change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population|||Score on a scale||Standard Error|Least Squares Mean
1366957|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S)|The CGI-S is a 7-point scale where investigator were asked to rate the severity of the participant’s illness at the time of assessment on severity of mental illness, where 1= normal, and 7= extremely ill. Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32 and 36. Analysis performed using Analysis of Covariance (ANCOVA) with covariates of site, CGI-S baseline score (Open label phase), treatment and CGI-S baseline score. In presented Last observation carried forward (LOCF) datasets, last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for remaining study visits of treatment period. The baseline value was defined as last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population.|||Score on a scale||Standard Error|Least Squares Mean
1366985|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 15|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
1366958|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Improvements (CGI-I)|The CGI-I is a 7-point scale where investigator were asked to assess the participant’s illness at the time of assessment (improved or worsened) relative to a baseline state. In this scale, 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; or 7= very much worse. Analysis was performed using Analysis of covariance with covariates of site, CGI-S baseline score and treatment. In presented Last-observation-carried-forward datasets, the last non-missing on therapy (OT) score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. Baseline value was defined as the last non-missing values at or prior to the randomization. Change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either baseline or post-baseline value was missing, the change from baseline was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population.|||Score on a scale||Standard Error|Least Squares Mean
1366959|NCT01602510|Secondary|Overall Survival in Study (TIME-SIS).|TIME-SIS was defined as the time to intervention (addition of pharmacotherapy or ECT) for any mood episode, or to the time when the participant is withdrawn for any reason after randomization. The premature discontinuation of a participant prior to reaching TIME, for any reason, was treated as an event related to bipolar disorder. All participants prematurely discontinued prior to the TIME event in this analysis were to be assumed to have reached TIME. TIMS-SIS was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
1366960|NCT01602510|Secondary|Time to Intervention for Depressive Episode (TIDep)|TIDep was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
1366961|NCT01602510|Secondary|Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan)|TIMan was analyzed using using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population.NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
1366962|NCT01602510|Primary|Time to Intervention for Any Mood Episode (TIME)|TIME is defined as being the time from entry into the randomized double-blind phase to the time of the first prescription of any additional pharmacotherapy or Electroconvulsive therapy (ECT) determined by the investigator to be necessary for treatment of a relapse and/or recurrence of a depressive, manic, hypomanic or mixed episode, whichever occurs first. TIME was measured relative to randomization date. Par. prematurely discontinued from the study prior to reaching the TIME event were censored at the time of discontinuation. Analysis was performed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level.|36 weeks (wks)|"Randomized (RD) Full analysis population: comprised of all randomized par. who took at least one dose of study medication and had at least one post-baseline efficacy/health outcomes assessment during randomized double-blind phase. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
1366963|NCT01602484|Secondary|Time to Apply Splint|Time it takes to apply splint|Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
1366964|NCT01602484|Secondary|Time to Prepare Splint|Time it takes to prepare splint supplies prior to splint application|Immediately following the operation, beginning with when medical personnel finish gathering supplies and ending when the materials are prepared to apply splint (approximately 2 minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
1366965|NCT01602484|Secondary|Time to Gather Supplies|Time it takes to gather supplies prior to splint application|Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
1366966|NCT01602484|Primary|Total Splint Application Time|Time it takes to apply post-op splint|Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
1366967|NCT01602471|Primary|[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan|Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.|Participants will be followed for an average of 6 weeks|||||||
1367001|NCT01602315|Secondary|Phase II: Non-Randomized Overall Survival (OS) by Treatment|Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 1 year|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Patients|||Number
1366968|NCT01602380|Secondary|Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health Related Quality of Life (HRQoL)|The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprises the following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of randomisation to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.|Quality of life questionnaires completed at baseline and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||months||Inter-Quartile Range|Median
1366969|NCT01602380|Secondary|Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment|EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456–65).|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||Days|||Number
1366970|NCT01602380|Secondary|Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment|DoCB was defined only for patients who had clinical benefit, as the time in days from date of randomisation until the date of disease progression.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|Only patients in the ITT analysis set (which included all randomised patients) who also had a clinical benefit were included in the DoCB analysis (n=180 for Fulvestrant arm and n=172 for Anastrozole arm).|||Months||Inter-Quartile Range|Median
1366971|NCT01602380|Secondary|Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment|CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||Percentage of participants|||Number
1366972|NCT01602380|Secondary|Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment|EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456–65).|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|EDoR analysis was based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).|||Days|||Number
1366973|NCT01602380|Secondary|Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment|DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off)..|Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 for Anastrozole arm).|||Months||Inter-Quartile Range|Median
1366974|NCT01602380|Secondary|Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment|ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response [PR] or complete response [CR]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).|||Percentage of participants|||Number
1366975|NCT01602380|Secondary|Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events|OS was defined as the time from randomisation until death by any cause. Two timepoints were planned for OS analysis: an interim OS analysis at the time of the data cut-off for PFS analysis and a final OS analysis when 50% of the deaths have occurred. The current OS data correspond to that of the interim analysis only and the outcome measure is reported as percentage of patients with events.|Baseline up to data cut-off for PFS analysis (up to approximately 38 months). Following disease progression, patients were to be contacted at 12 weekly intervals to to determine survival status.|The ITT analysis set included all randomised patients.|||Percentage of participants|||Number
1367002|NCT01602315|Secondary|Phase II: Randomized Overall Survival (OS) by Treatment|Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 1 year|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Patients|||Number
1367164|NCT01600287|Other Pre-specified|Induction Time|Time required for the first time achievement of two subsequent BIS values below or equal to 55|10 minutes||||seconds||Standard Deviation|Mean
1366976|NCT01602380|Primary|Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole|PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.|Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||Months||95% Confidence Interval|Median
1366977|NCT01602341|Secondary|Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation.|Baseline, Day 8, 15, 22, 29|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
1366978|NCT01602341|Secondary|Number of Participants With Local Tolerability Symptoms|Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
1366979|NCT01602341|Secondary|Number of Participants With Treatment-Emergent Adverse Events By Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
1366980|NCT01602341|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
1366981|NCT01602341|Secondary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities|Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
1366982|NCT01602341|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
1366983|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 29|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
1366984|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 22|ITT population included all participants, who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
1367003|NCT01602315|Secondary|Phase II: Non-Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|Scheme 1 (arm 3): Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm 3 (non-randomized arm)|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Percentages||95% Confidence Interval|Number
1366986|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 8|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
1366987|NCT01602315|Secondary|Phase II: Progression Free Survival (PFS) Based on Investigator's Assessment With Treatment|Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Days||95% Confidence Interval|Median
1366988|NCT01602315|Secondary|For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.|baseline, post baseline during the entire study period (approximately 1 year)|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
1366989|NCT01602315|Secondary|For Phase II: Notable Abnormal Vital Signs by Treatment|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.|approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
1366990|NCT01602315|Secondary|Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.|baseline, post baseline|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
1366991|NCT01602315|Secondary|Phase Ib: Notable Abnormal Vital Signs by Treatment|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.|approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
1366992|NCT01602315|Secondary|Phase Ib: Tmax for BYL719 After Continuous Dose Administration (Steady State)|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr||Full Range|Median
1366993|NCT01602315|Secondary|Phase Ib: Cmax for BYL719 After Continuous Dose Administration (Steady State)|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||ng/mL||Full Range|Median
1366994|NCT01602315|Secondary|Phase Ib: Plasma Pharmacokinetic Parameters for BYL719 After Continuous Dose Administration (Steady State)|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr*ng/mL||Full Range|Median
1366995|NCT01602315|Secondary|Phase Ib: Tmax for BYL719 by Treatment|Non compartmental Cmax derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr||Full Range|Median
1366996|NCT01602315|Secondary|Phase Ib: Cmax for BYL719 by Treatment|Non compartmental Cmax derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||ng/mL||Full Range|Median
1366997|NCT01602315|Secondary|Phase Ib: Primary Plasma Pharmacokinetic Parameters for BYL719 by Treatment|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|1 to 24 hours post dose (Day 1 Cycle 1)|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr*ng/mL||Full Range|Median
1366998|NCT01602315|Secondary|Phase II, Scheme 2 (Arm 2B): Overall Survival (OS) for the Cross-over|Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.|approximately 1 year|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Days||95% Confidence Interval|Median
1366999|NCT01602315|Secondary|Phase II, Scheme 1 (Arm 2B): Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|"Phase II: Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.~Complete response (CR); Partial response (PR); Stable disease (SD)"|Approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Rate||95% Confidence Interval|Number
1367000|NCT01602315|Secondary|For Phase Ib: Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|"Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C~CR=complete response PR=partial response"|approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Percentages||95% Confidence Interval|Number
1367004|NCT01602315|Secondary|Phase II: Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arms 1 and 2.|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Percentages||95% Confidence Interval|Number
1367005|NCT01602315|Secondary|Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1|Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Participants|||Number
1367006|NCT01602315|Secondary|Phase II: Randomized Best Overall Response as Per RECIST v1.1|Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Participants|||Number
1367007|NCT01602315|Secondary|Phase Ib: Progression Free Survival (PFS) as Per RECIST v1.1|Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C.|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Participants|||Number
1367008|NCT01602315|Secondary|Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1|Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab|approximately 6 months|Full analysis Set (FAS) consisted of those patients who, after crossing over had received at least one dose of BYL719.|||Participants|||Number
1367009|NCT01602315|Primary|Phase Ib: Area Under Curve (AUC) 0-24 for BYL719 by Treatment|Comparison of single-dose exposure of BYL719 dispersible tablet via G-tube in combination with cetuximab in RM HNSCC to that of Arm A (film-coated tables)|6 months|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr*ng/mL||Full Range|Median
1367010|NCT01602315|Primary|Phase II Arm 3: Progression Free Survival (PFS) as Per RECIST V1.1|Assessment of the anti-tumor activity of BYL719 in combination with cetuximab in patients resistant to platinum-based therapy and cetuximab.|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||months||95% Confidence Interval|Median
1367011|NCT01602315|Primary|Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review|"Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab.~6 months is an approximate timeframe."|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||participants|||Number
1367012|NCT01602315|Primary|For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 Days)|"Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets) and arm B (BYL719 administered as a drinkable suspension in patients with swallowing dysfunction).~6 months is an approximate timeframe."|until disease progression or intolerable toxicity (approximately 6 months)|Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.|||Participants|||Number
1367013|NCT01602315|Primary|Phase Ib Arm B: Probability That Distribution of Dose Limiting Toxicities (DLTs) is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)|Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm B (crushed film-coated tablets as an oral suspension with swallowing dysfunction). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.|until disease progression or intolerable toxicity (approximately 6 months)|Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.|||Probability of DLT rate|||Number
1367014|NCT01602315|Primary|Phase Ib Arms A: Probability That Dose Limiting Toxicities (DLTs) Rate is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)|Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.|until disease progression or intolerable toxicity (approximately 6 months)|Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.|||Probability of DLT rate|||Number
1367016|NCT01602224|Secondary|Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR])|Response categories in order of decreasing quality are: Stringent Complete Response(sCR),Complete Response(CR), Very Good Partial Response(VGPR),Partial Response(PR),Minimal Response(MR),Stable Disease(SD), or Progressive Disease(PD), according to the International Uniform Response Criteria for Multiple Myeloma.SCR:normal free light chain ration and no clonal cells in bone marrow;CR-no monoclonal protein(mp) in blood, no serum/urine,<5% plasma cells in bone marrow; VGPR-more than 90% decrease in mp and urine protein; PR->50% decrease in serum MP;SD-<25% decrease in mp; PD-25% increase compared to lowest value of serum mp, urine mp and no measurable mp.|Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months)|All randomized participants.|||participants|||Number
1367017|NCT01602224|Secondary|Participants With Best Overall Response (BOR) in Each Category|Stringent Complete Response-Complete Response and normal free light chain ration and no clonal cells in bone marrow Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow Very Good Partial Response-more than 90% decrease in mp and urine protein Partial Response- over 50% decrease in serum mp Stable Disease- less than 25 percent decrease of monoclonal protein Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp|Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)|All randomized participants.|||Participants|||Count of Participants
1367018|NCT01602224|Secondary|Number of Participants Developing Anti-tabalumab Antibodies||Baseline through Cycle 8|Zero participants analyzed, no data collected due to compound termination.||||||
1367019|NCT01602224|Secondary|PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab||Cycle (C)1 Day (D)1: 30 minutes C1 D4, 8, 11: Predose; C2 and C6-C10 D1: immediately after dose|All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters.|||micrograms times hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1367020|NCT01602224|Secondary|PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab||Cycle (C)1 Day (D)1: 30 minutes Post dose; C1 D4, 8, 11: Predose; C2 and C6-C10 D1:immediately after dose|All randomized participants who received at least 1 dose of study drug with evaluable PK values.|||hours||95% Confidence Interval|Mean
1367021|NCT01602224|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab|Maximum Concentration (Cmax) of Tabalumab.|Cycle (C)1 Day (D)1:2 hours Post dose; C1 D4, 8, 11: Predose; C2 and C6-C10 D1:immediately after dose|All randomized participants who received at least 1 dose of study drug and evaluable PK data.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1367022|NCT01602224|Secondary|Time to Next Treatment (TNT)|TNT is defined as the time from the date of randomization to the date of initiation of the first poststudy treatment course of anticancer therapy or death from any cause. Time to next treatment will be censored at the date of the last visit for participant who did not initiate additional anticancer therapy.|Baseline to Initiation of New Cancer Treatment or Death From Any Cause (18 Months)|All randomized participants.|||months||95% Confidence Interval|Median
1367023|NCT01602224|Secondary|Duration of Response (DoR)|DOR is measured by the International Myeloma Working Group Uniform Response Criteria: from the date of first evidence of a confirmed response to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, the DOR time will be censored at the last complete objective progression-free disease assessment date. Progressive disease is an increase of 25% from baseline in Serum M, Urine M, bone marrow plasma cell increase of 10 %, development of new bone lesions, development of new soft tissue plasmacytomas or bone lesions, hypercalcemia >11.5 milligrams per deciliter, decrease in hemoglobin of 2 grams per deciliter, rise in serum creatinine by 2 mg/deciliter.|Time from Response to Objective Disease Progression (assessed up to 38 months)|All randomized participants who received at least 1 dose of study drug and had a response.|||months||95% Confidence Interval|Median
1367024|NCT01602224|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from the date of randomization to the date of first observed objective progression or death due to study disease. Time to progression will be censored as for PFS for those participants not known to have progressed or that died from other causes.|Baseline to Objective Disease Progression or Death (assessed up to 9 months)|All randomized participants, with 79 participants censored.|||months||95% Confidence Interval|Median
1367025|NCT01602224|Secondary|Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score|"BPI is assessed by 7 questions rated 0 for no pain and higher numbers indicated more pain."|Baseline through End of Treatment (19 months)|All randomized participants.|||Participants|||Count of Participants
1367026|NCT01602224|Secondary|Time to First Skeletal-Related Event (SRE)|Time to first SRE is defined as time from randomization to any one of the following related to multiple myeloma: New Pathological Fracture, Spinal Cord Compression, Surgery to the Bone, Radiation to the Bone collected until participant death, study closure or lost to follow up. Participants not known to have had an SRE at the time of the analysis were censored at the date of their last complete documented assessment for SRE.|Baseline to Date of First Skeletal Related Event (assessed up to 19 months)|All randomized participants.|||months||95% Confidence Interval|Median
1367027|NCT01602224|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For participants who were alive, overall survival was censored at the last contact.|Baseline to Death From Any Cause (assessed up to 19 months)|All randomized participants.|||months||95% Confidence Interval|Median
1367028|NCT01602224|Primary|Progression Free Survival (PFS)|PFS is defined as the time from date of first dose to the first observation of disease progression or death due to any cause. If a participant does not have a complete baseline disease assessment, then the PFS time is censored at the enrollment date, regardless of whether or not objectively determined disease progression (Increase of > 25% from lowest response in serum M component, urine M component, bone marrow plasma cell percentage, development of bone lesions) or death has been observed for the participant. If a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time is censored at the last complete objective progression-free disease assessment date.|Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months)|All randomized participants.|||months||95% Confidence Interval|Median
1367165|NCT01600287|Other Pre-specified|Induction Dose of Propofol|Dose of propofol needed for induction|10 minutes||||mg per kg body weight||Standard Deviation|Mean
1367030|NCT01602068|Primary|Proportion of Subjects With AC Cell Count of Zero on Day 7|Proportion of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups|At Day 7 (plus or minus two days) following the study treatment|This was an exploratory study and therefore a number of efficacy and safety parameters were evaluated. In all measures there was no significant difference between the active and non-active arms.|||Participants|||Count of Participants
1367031|NCT01602016|Secondary|Improved Stereotyped Behavior and Improved Social Skills|Stereotyped behavior (as measured by the OACIS (not at 6 weeks), ASQ, RBS-R, and ABC) and social skills (as measured by the Vineland (not at 6 weeks), ASQ, and SRS) will be the secondary outcomes.|(baseline, 6, and 12 weeks)|No data because no patients were analyzed.||||||
1367032|NCT01602016|Primary|Language Improvement|Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.|(baseline and 12 weeks )|The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.||||||
1367033|NCT01601977|Secondary|Exacerbation Frequency|patient reported exacerbations following 6 weeks of device usage|6 weeks||||exacerbations|||Number
1367034|NCT01601977|Secondary|Exercise Capacity|6 minute walk test|6 weeks|1 patient declined to complete the walking test|||m||Standard Deviation|Mean
1367035|NCT01601977|Secondary|Control of Nocturnal Hypoventilation|mean tcCO2|2 weeks||||kPa||Standard Deviation|Mean
1367036|NCT01601977|Secondary|Total Sleep Time|Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST|baseline, 6 weeks||||minutes||Standard Deviation|Mean
1367037|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|6 weeks||||units on a scale||Standard Deviation|Mean
1367038|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|2 weeks||||units on a scale||Standard Deviation|Mean
1367039|NCT01601977|Primary|Control of Nocturnal Hypoventilation|transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device|baseline, 6 week assessment||||kPa||Standard Deviation|Mean
1367040|NCT01601847|Secondary|Bone Density|Measured by bone speed of sound (ultrasound)|Measured at the 12 month adjusted age visit|Bone density was not performed if (1) infant could not come to the clinic for their 12 month visit and the visit was done in the home (2) they missed their 12 month visit (3) the ultrasound was under repair, or (4) infant could not participate with the ultrasound to get a sufficient quality reading.|||m/s||Full Range|Median
1367041|NCT01601847|Secondary|Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay|Measured using the Phadiatop Infant IgE panel|Measured at the 12 month adjusted age visit|Positive result is >0.35 U/L PAU/l|||Participants|||Count of Participants
1367042|NCT01601847|Primary|Number of Infants With Recurrent Wheezing|Recurrent wheezing was defined as more than 1 episode of wheezing reported during the study period. Separate episodes were defined as occurring at least 2 weeks apart.|up to 12 months adjusted age|Infants that were withdrawn, completely lost to follow-up, who died, or for whom recurrent wheezing status was indeterminate due to a missing 12 month visit (n=8) were not included in the primary analysis.|||Participants|||Count of Participants
1367043|NCT01601821|Secondary|Number of Participants Who Discontinued|Number of participants who discontinued the study treatment due to any reason is reported.|Month 12|Analysis population included all participants enrolled in the study.|||participants|||Number
1367044|NCT01601821|Secondary|Incidence of Anemia|Diagnostic criterion for anemia was based on the laboratory results; in men: hemoglobin (Hb) <14 gram per deciliter (g/dL), hematocrit (Hct) <42%, or red blood cells (RBCs) <4.5 million/liter (million/L); for women: Hb <12 g/dL, Hct <37%, or RBC < 4 million/L. Percentage of participants with anaemia was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1367045|NCT01601821|Secondary|Percentage of Participants With Efficacy Failure or Premature Elimination|Efficacy failure was defined as the first occurrence of acute rejection, graft loss, or death. Premature elimination was defined as elimination from the study for any other reason.|Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1367046|NCT01601821|Secondary|Incidence of Histologically Confirmed Lymphoproliferative Disease|Lymphoproliferative disorder represents an abnormal proliferation of B cells in response to either primary or reactivated infection with Epstein-Barr virus. Percentage of participants with histologically confirmed lymphoproliferative disease was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1367047|NCT01601821|Secondary|Incidence of Presumptive or Documented Infection|Presumptive or documented infection during the 12 months after transplantation; was confirmed by culture, biopsy, or serology and reported. Percentage of participants with presumptive or documented infection was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1367048|NCT01601821|Secondary|Percentage of Participants With Graft Survival|Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Month 12|PP4 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of graft loss.|||percentage of participants|||Number
1367050|NCT01601821|Secondary|Histologic Grade of First Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria. Grade 1A: cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: with severe tubulitis (>10 cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis and Grade 3: transmural arterits and/or fibrinoid necrosis. Data is reported as percentage of participants.|Baseline up to Month 12|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1367051|NCT01601821|Secondary|Incidence of Biopsy-Confirmed Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy using Banff criteria. Percentage of participants with biopsy-confirmed acute rejection was reported.|Baseline up to Month 6|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6.|||percentage of participants|||Number
1367052|NCT01601821|Secondary|Glomerular Filtration Rate (GFR) by Nankivell Method|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR was calculated using the Nankivell formula. GFR by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male or 25 for female). A normal GFR is greater than (>)90 mL/min per 1.73 m^2 [mL/min/1.73 m^2], although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<)15 mL/min/1.73 m^2 indicated kidney failure.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.|||mL/min/1.73 m^2||Standard Deviation|Mean
1367053|NCT01601821|Secondary|Creatinine Clearance|Creatinine clearance (CCr) is a measure of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 millimeters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.|||mL/min||Standard Deviation|Mean
1367054|NCT01601821|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 milligram per deciliter (mg/dL) for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.|||mg/dL||Standard Deviation|Mean
1367055|NCT01601821|Primary|Incidence of Efficacy Failure|Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported.|Baseline up to Month 12|Per-protocol 1 (PP1) population included all participants who had completed study, also included those who dropped out of study due to occurrence of death, graft loss, or biopsy-confirmed acute rejection and had no major protocol deviations.|||percentage of participants|||Number
1367056|NCT01601782|Primary|Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging|Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan.|Up to 13 minutes||||percent correlation|||Number
1367057|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
1367058|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
1367059|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
1367166|NCT01600287|Secondary|Intraoperative Phenylephrine Used (Pre CPB)|total phenylephrine dose needed to be used in the pre CPB period to maintain hemodynamic stability|2 hours(approx)||||microgram per Kg body weight||Standard Deviation|Mean
1367060|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
1367061|NCT01601704|Primary|Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)|The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
1367062|NCT01601691|Secondary|Rectum Radiation Dose|Rectum dose will be calculated based on CT scans after brachytherapy.|1 day, 4 weeks, 8 weeks|||||||
1367063|NCT01601691|Secondary|Side Effects|Possible side effects will be collected by subject interview and physical examination on specified time frame.|1 day, 4 weeks, 8 weeks, 12 weeks|||||||
1367064|NCT01601691|Primary|Spacer Volume Half Life|Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.|1 day, 4 weeks, 8 weeks, up-to 16 weeks||||days||Standard Deviation|Mean
1367065|NCT01601626|Other Pre-specified|RAL AUC in Participants Enrolled in Arm C|Describe RAL plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the RAL concentration at the pre-dose draw was above the assay's lower limit of quantification (5 ng/mL).|||hours*ng/mL||Inter-Quartile Range|Median
1367066|NCT01601626|Other Pre-specified|RAL Cmax and Cmin in Participants Enrolled in Arm C|Describe RAL plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the RAL concentration at the pre-dose draw was above the assay's lower limit of quantification (5 ng/mL).|||ng/mL||Inter-Quartile Range|Median
1367067|NCT01601626|Other Pre-specified|RBT AUC in Participants Enrolled in Arms A and C|Describe RBT plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, followed the protocol-required RBT dosing schedule, and the RBT concentration at the pre-dose draw was above the assay's lower limit of quantification (75 ng/mL).|||hours*ng/mL||Inter-Quartile Range|Median
1367068|NCT01601626|Other Pre-specified|RBT Cmax and Cmin in Participants Enrolled in Arms A and C|Describe RBT plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, followed the protocol-required RBT dosing schedule, and the RBT concentration at the pre-dose draw was above the assay's lower limit of quantification (75 ng/mL).|||ng/mL||Inter-Quartile Range|Median
1367069|NCT01601626|Other Pre-specified|LPV AUC in Participants Enrolled in Arms A, B, and C|Describe LPV plasma PK characteristics (area under the curve [AUC] between 0 and 12 hours) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the LPV concentration at the pre-dose draw was above the assay's lower limit of quantification (20 ng/mL).|||hours*ng/mL||Inter-Quartile Range|Median
1367140|NCT01600586|Secondary|Number of Days to Full Oral Feeds|Aim: Quantify the effect of the PAL intervention on efficiency of sucking and time to reaching full oral feeds in comparison to controls. Data on the number of days from Day 0 of the study to the date of first documented full oral feed, up to 70 days (or date of death from any cause) were be recorded from the chart.|Day 0 of the study to the date of first documented full oral feed (up to 70 days)||||days||Inter-Quartile Range|Median
1367070|NCT01601626|Other Pre-specified|LPV Cmax and Cmin in Participants Enrolled in Arms A, B, and C|Describe LPV plasma pharmacokinetic (PK) characteristics (maximum concentration [Cmax] and minimum concentration [Cmin]) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the LPV concentration at the pre-dose draw was above the assay's lower limit of quantification (20 ng/mL).|||ng/mL||Inter-Quartile Range|Median
1367071|NCT01601626|Secondary|Percent of Participants Who Experienced a New AIDS-defining Illness or Died|New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness or died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367072|NCT01601626|Secondary|Percent of Participants Who Died|The percent of participants who died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367073|NCT01601626|Secondary|Percent of Participants Who Experienced a New AIDS-defining Illness|New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367074|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 72|The difference in CD4 count from baseline to week 72 was calculated as the CD4 count at week 72 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 72 weeks|Participants who had CD4 cell count data available at baseline and week 72 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1367075|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 48|The difference in CD4 count from baseline to week 48 was calculated as the CD4 count at week 48 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 48 weeks|Participants who had CD4 cell count data available at baseline and week 48 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1367076|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 24|The difference in CD4 count from baseline to week 24 was calculated as the CD4 count at week 24 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 24 weeks|Participants who had CD4 cell count data available at baseline and week 24 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1367077|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 8|The difference in CD4 count from baseline to week 8 was calculated as the CD4 count at week 8 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 8 weeks|Participants who had CD4 cell count data available at baseline and week 8 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
1367078|NCT01601626|Secondary|Number of Participants Who Experienced MTB IRIS|The number of participants who experienced MTB immune reconstitution inflammatory syndrome (IRIS) was summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||Participants|||Count of Participants
1367079|NCT01601626|Secondary|Cumulative Probability of HIV Virologic Failure at Week 72|Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. The percent of participants with HIV virologic failure at week 72 was calculated using a Kaplan-Meier estimator with an associated standard error. The confidence interval was calculated using a log-log transformation. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At weeks 16, 24, 48, and 72|All randomized participants were included.|||cumulative events per 100 participants||95% Confidence Interval|Number
1367080|NCT01601626|Secondary|Percent of Participants Who Experienced HIV Virologic Failure|Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. Participants who were missing data due to being lost-to-follow-up or dead were coded as virologic failures. The percent of participants who experienced HIV virologic failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At weeks 16, 24, 48, and 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367167|NCT01600287|Secondary|Global Score|overall performance assessment of the system calculated as= [(MDAPE+Wobble)/percentage of time BIS remains within target]x100 Lower score indicates better overall performance|8 hours (approx)||||percentage of time||Standard Deviation|Mean
1367081|NCT01601626|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One TB Drug Due to Toxicity|The percent of participants who interrupted or discontinued at least one TB drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through to the discontinuation of the last TB drug|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367082|NCT01601626|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One HIV Drug Due to Toxicity|The percent of participants who interrupted or discontinued at least one HIV drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367083|NCT01601626|Secondary|Number of Participants Reporting a Grade 3 or 4 Laboratory Abnormality|The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) laboratory abnormality were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||Participants|||Count of Participants
1367084|NCT01601626|Secondary|Number of Participants Reporting a Grade 3 or 4 Sign or Symptom|The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) sign or symptom were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||Participants|||Count of Participants
1367085|NCT01601626|Secondary|Percent of Participants Whose HIV Viral Load Was Less Than 50 Copies/mL at Week 48|The percent of participants whose HIV viral load was less than 50 copies/mL at week 48 was calculated with an associated standard error. Participants who were lost-to-follow-up or dead by week 48 or had missing RNA at week 48 were coded as having HIV viral load greater than 50 copies/mL. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|48 weeks|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367086|NCT01601626|Secondary|Percent of Participants Who Experienced TB Relapse/Recurrence and Who Had TB Drug Resistance|TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The drug resistance was determined based on phenotypic methods. The percent of participants who experienced TB relapse/recurrence and who had TB drug resistance was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At or after 24 weeks and through week 72|All participants who experienced TB relapse/recurrence were included.|||participants||95% Confidence Interval|Number
1367087|NCT01601626|Secondary|Percent of Participants Who Experienced TB Relapse/Recurrence|TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The percent of participants who experienced TB relapse/recurrence was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At or after 24 weeks and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367088|NCT01601626|Secondary|Percent of Participants Who Experienced TB Treatment Failure|TB treatment failure was defined as having a MTB-positive culture after 16 weeks of TB treatment for a participant who was documented to be taking TB medications. The percent of participants who experienced TB treatment failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After 16 weeks and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367089|NCT01601626|Secondary|Percent of Participants Who Experienced Sputum Conversion at Week 8.|Sputum conversion was defined as culture MTB-negative at week 8 or AFB smear negative at week 8 (and culture contaminated or missing at week 8); there were no Xpert MTB/RIF results at week 8. The percent of participants experienced sputum conversion at week 8 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|8 weeks|Participants who were either culture MTB-positive at entry; AFB smear positive at entry (and culture MTB-negative, contaminated, or missing at entry); or Xpert MTB/RIF positive at entry (and culture or smear negative, contaminated, or missing at entry) were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1367090|NCT01601626|Primary|Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.|The percent of participants whose HIV viral load was less than 400 copies/mL at week 48 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. Participants who were lost-to-follow-up or dead by week 48 or had missing results at week 48 were coded as having HIV viral load greater than 400 copies/mL. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|48 weeks|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
1367091|NCT01601470|Secondary|Adverse Events, Serious Adverse Events and Deaths Were Monitored From Screening to End of Study|Number of patients with adverse events, serious adverse events and death|From the screening visit until 30 days past the final study assessment|Safety Analysis Set: This set included participants who received at least one dose of study drug.|||Participants|||Number
1367092|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil will be assessed. 8pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||hours||Full Range|Median
1367093|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration (Cmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||ng/mL||Standard Deviation|Mean
1367094|NCT01601470|Primary|Terminal Elimination Half-life (T1/2) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. T1/2 is a mathematically-derived value from all measurements. T1/2 is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||hours||Standard Deviation|Mean
1367095|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||h*ng/mL||Standard Deviation|Mean
1367096|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||h*ng/mL||Standard Deviation|Mean
1367097|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Tmax is a mathematically-derived value from all measurements. Tmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||hours||Full Range|Median
1367098|NCT01601470|Primary|Minimum Plasma Concentration Following Drug Administration at Steady State (Cmin,ss) of LCZ696 Analytes (AHU377, LBQ696 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmin is a mathematically-derived value from all measurements. Cmin is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||ng/mL||Standard Deviation|Mean
1367099|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmax is a mathematically-derived value from all measurements. Cmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||ng/mL||Standard Deviation|Mean
1367141|NCT01600586|Secondary|Hospital Length of Stay|Description: Data on hospital stay was recorded from the chart. The participants were be followed for the duration of the hospital stay from the time of consent for participation to the time discharge from the NICU is documented.|days from consent to discharge||||days||Inter-Quartile Range|Median
1367100|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of LCZ696 Analytes|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||h*ng/mL||Standard Deviation|Mean
1367101|NCT01601431|Primary|ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.|1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.|1 year||||Participants|||Count of Participants
1367102|NCT01601236|Other Pre-specified|Change in Mean HbA1c|Change from baseline mean HbA1c (%) to Week 36|Week 36|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||%HbA1c||Standard Deviation|Mean
1367103|NCT01601236|Secondary|Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol|Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol|Visit 6, 9, 12, and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Deviation|Mean
1367104|NCT01601236|Secondary|Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria|Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||Participants|||Count of Participants
1367105|NCT01601236|Secondary|Percent Change From Baseline in Protein to Creatinine Ratio (PCR)|Percent change from baseline in PCR|Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Error|Mean
1367106|NCT01601236|Secondary|Percent Change From Baseline in eGFR by Visit|Percent change from baseline in eGFR by visit|Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Deviation|Mean
1367107|NCT01601236|Secondary|Percent Change in eGFR Calculated Using Cystatin C|Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2.|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Deviation|Mean
1367108|NCT01601236|Secondary|Complete or Partial Remission of Proteinuria|Proportion of patients with complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria at Visit 12 (Week 36) and/or at Visit 17 (Week 52)|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||Participants|||Count of Participants
1367109|NCT01601236|Secondary|Time to Doubling of Serum Creatinine or ESRD or Death|The frequency doubling of serum creatinine or progression to ESRD or death was small therefore this parameter could not be analyzed.|Visit 12 (Week 36) or Visit 17 (Week 52)|||||||
1367110|NCT01601236|Secondary|Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death||Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||Participants|||Count of Participants
1367111|NCT01601236|Secondary|Percent Change in eGFR at Visit 17|Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening|Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Error|Least Squares Mean
1367112|NCT01601236|Primary|Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12|Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening|Visit 12 (Week 36)|This trial had an adaptive design that pre-specified the closure of the 32 U (units) (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Error|Least Squares Mean
1367113|NCT01601132|Primary|Apparent Total Volume of Distribution (Vd/F) of Theophylline|Apparent total volume of distribution after oral administration, calculated as Dose /(AUC0-∞) * Apparent first-order elimination rate constant [Kel])|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||liters||Standard Deviation|Mean
1367168|NCT01600287|Secondary|Divergence|slope of the linear regression curve of performance error against time.|8 hours (approx)||||errors per second||Standard Deviation|Mean
1367115|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||hours*μg/mL||Standard Deviation|Mean
1367116|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time of the Last Quantifiable Concentration[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||hours*μg/mL||Standard Deviation|Mean
1367117|NCT01601132|Primary|Maximum Plasma Concentration (Cmax) of Theophylline|The maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after another single dose on Day 19 following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters.|||μg/mL||Standard Deviation|Mean
1367118|NCT01601132|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Theophylline|The time to each the maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after a single dose on Day 19, following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters. Patients with available data are included in the analysis.|||hours||Full Range|Median
1367119|NCT01600950|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus|AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.||||||
1367120|NCT01600950|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus|Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.||||||
1367121|NCT01600950|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)|tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.|||hours (hr)||Full Range|Median
1367122|NCT01600950|Secondary|Total Glucose Infused (Gtot)|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.|||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1367123|NCT01600950|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.|||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
1367124|NCT01600950|Primary|Pharmacodynamics: Duration of Action of LY2963016 and Lantus|Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant’s blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received study drug during Periods 1 or 2. Participants were analyzed based on treatment they received. The numbers of participants censored were 7 for both LY2963016 and Lantus groups. Maximum duration of actions is based on participants who reached the end of action before 42 hours: 13 participants for both groups.|||hours (hr)||Full Range|Median
1367125|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS|||percent change in saline signal||Standard Error|Mean
1367126|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS|||percent change in saline signal||Standard Error|Mean
1367142|NCT01600586|Secondary|Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5)|Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group.|Day 0, and Day 5|Specific data is no longer available, Outcome is described here: http://pediatrics.aappublications.org/content/133/3/462.full||||||
1367127|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule|"Scans will be analyzed for task-related prefrontal activation~Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)"|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS|||percent change in saline signal||Standard Error|Mean
1367128|NCT01600729|Primary|Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Intra-rater (within raters) agreement of the FWS-A scores (0=none; 1=mild; 2=moderate; 3=severe) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 65 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale at 2 different time-points on Day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for WKS was provided.|Day 1|Participants from the Reliability population (all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1) who had 2 assessments on Day 1 available for analysis.|||Kappa statistics||95% Confidence Interval|Mean
1367129|NCT01600729|Primary|Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|Reliability population included all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1.|||Kappa statistics||95% Confidence Interval|Mean
1367130|NCT01600716|Other Pre-specified|Duration of Treatment Effect Through Week 52|The duration of treatment effect is the time to patient request for retreatment.|Up to 52 Weeks|Intent-to-Treat Population: all randomized patients|||Weeks||95% Confidence Interval|Median
1367131|NCT01600716|Secondary|Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points|||Scores on a Scale||Standard Deviation|Mean
1367132|NCT01600716|Secondary|Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)|Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points|||Centimeters of Water (cm H2O)||Standard Deviation|Mean
1367133|NCT01600716|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points|||Milliliters (mL)||Standard Deviation|Mean
1367134|NCT01600716|Primary|Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes|Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).|Baseline, Week 6|Intent-to-Treat Population: all randomized patients|||Episodes||Standard Deviation|Mean
1367135|NCT01600703|Secondary|Apolipoprotein B100 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B100 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours||||mg/kg/day||Standard Error|Mean
1367136|NCT01600703|Primary|Apolipoprotein B48 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B48 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours||||ug/kg/day||Standard Error|Mean
1367137|NCT01600677|Secondary|Hospital Readmission Rates|Determine the percentage of patients that are readmitted to the hospital within 30 days of discharge|30 day||||% readmissions|||Number
1367138|NCT01600677|Secondary|Medication-reconciliation Errors During Transition From Hospital to Home|Using the previously validated and reliable medication discrepancy tool (MDT)|90-day||||Participants with errors|||Number
1367139|NCT01600677|Primary|Medication Adherence|Will be measured by: (number of doses/ doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts (control))|90-day||||percentage of medication adherence||Standard Deviation|Mean
1367145|NCT01600495|Secondary|Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.|Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.|10 hours|All patients were invited to answer the questionnaire.|||participants|||Number
1367146|NCT01600495|Secondary|Duration From Start of Labor Until Birth|The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.|10 hours|Analyzing the duration of labor|||min||Standard Deviation|Mean
1367147|NCT01600495|Secondary|Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia|Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.|10 hours|Analyzing the date of application of pharmacological analgesia.|||cm||Standard Deviation|Mean
1367148|NCT01600495|Primary|Classification of Pain During Labor by Visual Analogue Scale|"To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.~Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled no pain associated with a score of 0 mm and at the other end worst pain imagined with a score 100 mm)"|30 minutes|We evaluated 46 patients, divided into 23 ENT group and 23 in the control group.|||mm||Standard Deviation|Mean
1367149|NCT01600482|Secondary|Device Success|Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study.|30 days +/- 7 days|7 patients in the MP group did not have TTH recorded.|||Number of patients|||Number
1367150|NCT01600482|Secondary|Procedure Success|Procedure Success 30 days +/- 7 days|30 days +/- 7 days|7 patients were excluded in Manual Compression group as there was no TTH data recorded.|||Number of patients|||Number
1367151|NCT01600482|Secondary|Time to Discharge-ability|Time to discharge-ability|30 days +/- 7 days|107 did not have time to dischargeability data collected.|||Minutes||Standard Deviation|Mean
1367152|NCT01600482|Secondary|Time to Ambulation|Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding.|With in the first 30 days +/- 7 days following the procedure|62 patients did not have TTA recorded.|||minutes||Standard Deviation|Mean
1367153|NCT01600482|Secondary|The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.|combined rate of minor complications with in 30 +/- 7 days following procedure.|With in the first 30 days +/- 7 days following the procedure||||minor complications|||Number
1367154|NCT01600482|Primary|The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)|Time to hemostasis|With in the first 30 days +/- 7 days following the procedure|7 subjects in manual compression group where TTH was not recorded.|||minutes||Standard Deviation|Mean
1367155|NCT01600482|Primary|The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.|rate of major complications with in 30 +/- 7 days following the PCI procedure.|With in the first 30 days +/- 7 days following the procedure||||major complications|||Number
1367156|NCT01600326|Secondary|Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart|Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).|15 to 555 days post treatment||||Participants|||Count of Participants
1367157|NCT01600326|Primary|Pain Level and Interference With Activity|"Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference.~A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis.~Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days)."|Up to 23 days|One data point is missing for time point one for Plasma Injection Group, as noted below.|||units on a scale||Full Range|Mean
1367158|NCT01600287|Other Pre-specified|Number of Times Rate of Propofol Changed Manually|Number of times rate of propofol needed to be changed manually|8 hours(aprrox)||||times per hour||Full Range|Median
1367159|NCT01600287|Other Pre-specified|Total Off CPB Propofol Used (mg/kg/hr|total dosage of propofol used on per kg body weight per hour basis in the period before and after cardiopulmonary bypass period.|6 hours(approx)||||mg per kg body weight per hour||Standard Deviation|Mean
1367160|NCT01600287|Other Pre-specified|Total Fentanyl Used (µg/kg)|total fentanyl used in the whole duration of surgery on per kg body weight basis|8 hours(approx)||||microgram per kg body weight||Standard Deviation|Mean
1367161|NCT01600287|Other Pre-specified|Total Propofol Used (mg/kg/hr)|total propofol used based on per kg body weight per hour for the whole duration of surgery|8 hours (approx)||||mg per kg body weight per hour||Standard Deviation|Mean
1367162|NCT01600287|Other Pre-specified|Percentage Fall in MAP During Induction|percentage fall in mean arterial pressure from baseline during induction|15 minutes||||percentage of fall from baseline||Standard Deviation|Mean
1367163|NCT01600287|Other Pre-specified|Minimum BIS During Induction|Bispectral Index(BIS) is an EEG-based objective measure of anesthetic depth with values ranging from 100 to 0, lower number indicating greater depth of anesthesia. Values between 40 to 60 indicate adequate depth required for surgery. During induction of anesthesia, there is a tendency of overshooting the adequate depth of anesthesia, due to use of higher dose and rate of administration required for induction. The minimum BIS achieved during induction is a measure of this overshoot. The less the minimum value, the more is the overshoot, worse the outcome is. The minimum BIS during induction is automatically stored in the PC used for the study.|15 minutes||||Bispectral Index||Standard Deviation|Mean
1367170|NCT01600287|Secondary|Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|Approximately 8 hours||||percentage of time||Standard Deviation|Mean
1367171|NCT01600287|Secondary|Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline|The duration of time heart rate remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|Approximately 8 hours||||percentage of time||Standard Deviation|Mean
1367172|NCT01600287|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|Approximately 8 hours||||errors per participant||Standard Deviation|Mean
1367173|NCT01600287|Secondary|Median Absolute Performance Error(MDAPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_).The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|Approximately 8 hours||||errors per participant||Standard Deviation|Mean
1367174|NCT01600287|Secondary|Median Performance Error(MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during propofol anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|Approximately 8 hours||||errors per participant||Standard Deviation|Mean
1367175|NCT01600287|Primary|Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target|The primary outcome to be measured is the ability of the system to keep the depth of anesthesia in the target range, i.e, Bispectral Index(BIS) value of 50+/- 10. This will assess the ability of the system to prevent intra-operative awareness of the patients and at the same time avoid excessive depth of anesthesia with its accompanying adverse effects.|Approximately 8 hours||||percentage of time||Standard Deviation|Mean
1367176|NCT01600222|Secondary|Efficacy Evaluation|The percentage of subjects who achieved ‘controlled disease’ (i.e., Clear or Almost clear) according to the Investigator’s Global Assessment (IGA) of disease severity on the trunk, limbs and scalp at Days 28 (Visit 3) and End of treatment (EoT) were presented.|4 weeks I 28 days and End of treatment|"The percentage of subjects achieving controlled disease on Day 28 (n=35) was calculated from the full analysis set.~The percentage of subjects achieving controlled disease at End of Treatment (n=37) was was calculated from the full analysis set using a last observation carried forward approach."|||percentage of subjects|||Number
1367177|NCT01600222|Secondary|Pharmacokinetic Evaluation T1/2|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||h||Full Range|Mean
1367178|NCT01600222|Secondary|Pharmacokinetic Evaluation Tmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Tmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||h||Full Range|Median
1367179|NCT01600222|Secondary|Pharmacokinetic Evaluation AUCinf|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||pg/ml||Full Range|Mean
1367180|NCT01600222|Secondary|Pharmacokinetic Evaluation AUClast|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol AUClast are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||pg/ml||Full Range|Mean
1367181|NCT01600222|Secondary|Pharmacokinetic Evaluation Cmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Cmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations.|||pg/ml||Full Range|Mean
1367182|NCT01600222|Secondary|Number of Subjects Who Discontinued From the Study|Number of subjects who discontinued from the study due to adverse events.|Baseline to Day 28||||participants|||Number
1367183|NCT01600222|Secondary|Change in Heart Rate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (heart rate).|Baseline and Day 28||||beats/min||Standard Deviation|Mean
1367184|NCT01600222|Secondary|Change in Blood Pressure From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (blood pressure).|Baseline and Day 28||||mmHg||Standard Deviation|Mean
1367185|NCT01600222|Secondary|Change in Plasma Parathyroid Hormone (PTH) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in plasma PTH from Baseline to Day 28.|Baseline and Day 28||||pmol/L||Standard Deviation|Mean
1367186|NCT01600222|Secondary|Change in Serum Alkaline Phosphatase (ALP) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum ALP from Baseline to Day 28.|Baseline and Day 28||||IU/L||Standard Deviation|Mean
1367187|NCT01600222|Secondary|Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary phosphate:creatinine ratio from Baseline to Day 28.|Baseline and Day 28||||mmol/g||Standard Deviation|Mean
1367188|NCT01600222|Secondary|Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary phosphate excretion from Baseline to Day 28.|Baseline and Day 28||||mmol/24H||Standard Deviation|Mean
1367189|NCT01600222|Secondary|Change in Serum Phosphate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum phosphate from Baseline to Day 28.|Baseline and Day 28||||mmol/L||Standard Deviation|Mean
1367190|NCT01600222|Secondary|Number of Participants With an Adverse Drug Reaction (ADR)|Adverse drug reactions (ADRs) were defined as adverse events for which the investigator has not described the causal relationship to investigational medication as “not related”.|Baseline to Day 28||||participants|||Number
1367191|NCT01600222|Secondary|Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28|Serum cortisol concentrations at 30 and 60 minutes after injection were measured in order to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration is ≤18mcg/dl at 30 minutes after the injection.|Day 28||||Subjects|||Number
1367192|NCT01600222|Primary|Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary calcium:creatinine ratio from Baseline to Day 28.|Baseline and Day 28||||mmol/g||Standard Deviation|Mean
1367193|NCT01600222|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary calcium excretion from Baseline to Day 28 in 24-hour.|Baseline and Day 28||||mmol/24H||Standard Deviation|Mean
1367194|NCT01600222|Primary|Change in Albumin-corrected Serum Calcium From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in albumin-corrected serum calcium from Baseline to Day 28.|Baseline and Day 28||||mmol/L||Standard Deviation|Mean
1367195|NCT01600222|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge)|HPA-axis testing by means of the rapid standard-dose cosyntropin test (ACTH-challenge test) for detection of adrenal suppression.|Day 28|Per protocol analysis set.|||Subjects|||Number
1367196|NCT01600092|Secondary|Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||Baseline and 42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint|||Percentage of participants||95% Confidence Interval|Number
1367197|NCT01600092|Secondary|Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint|||Titer||95% Confidence Interval|Geometric Mean
1367198|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Intussusception|The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception|Up to Day 185|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.|||Participants|||Number
1367199|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.|Up to 7 days after any vaccination (up to 147 days)|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.|||Participants|||Number
1367200|NCT01600092|Primary|Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint|||Titer||95% Confidence Interval|Geometric Mean
1367201|NCT01600053|Secondary|Recording of the Occurrence of Adverse Events||From date of first dose until the date of first documented progression or date of death from any cause, whichever came first|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Please see adverse event listing for additional information.|||participants|||Number
1367202|NCT01600053|Primary|Eradication of Residual Disease From the Marrow||From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Data were not collected from the 11 participants before study termination.||||||
1367203|NCT01600014|Secondary|The Change in AK Count From Randomisation to 8 Weeks After Randomisation|The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups|8 weeks after randomisation||||AK count||Standard Deviation|Mean
1367204|NCT01600014|Secondary|Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12|The analysis was done separately for the field recalcitrant subgroup, the field recurrent subgroup, and overall for all treated subject (Analysis 1, 2, and 3, respectively)|From last treatment cycle through to Month 12||||participants|||Number
1367205|NCT01600014|Primary|Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation|The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)|8 weeks after randomisation||||participants|||Number
1367206|NCT01599832|Other Pre-specified|Progression-free Survival|Specifically, whether baseline K^trans is associated with progression-free survival. Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)|2 years|Included those with a baseline K^trans value|||weeks||Full Range|Median
1367207|NCT01599832|Secondary|Changes in sVEGFR2 From Baseline to Post-treatment||Baseline and 1 week post-treatment|Data not collected||||||
1367208|NCT01599832|Secondary|Changes in Blood Pressure From Baseline to Post-treatment||Baseline and 1 week post-treatment|Data were not collected||||||
1367209|NCT01599832|Secondary|Change in K^Trans From Baseline|K^trans is a derived measure from dynamic contrast-enhanced magnetic resonance imaging that reflects perfusion rate and capillary permeability. The change is reported as the log-transformed ratio of K^trans value at follow-up/baseline.|Baseline and 1, 8, 16, and 24 weeks post-treatment|Included those with a baseline K^Trans value and at least 1 K^trans value at follow-up|||unitless [log(ratio)]||Standard Deviation|Mean
1367210|NCT01599832|Primary|Disease Progression|Specifically, whether the change in K^trans (the rise from nadir) as a time-dependent covariate, as assessed by the method described in Donner, is associated with disease progression.Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)|2 years|The accrued sample size of n=20 did not permit further assessment (as described in the Outcome Measure Description) of the primary endpoint, so simply reporting the median progression-free survival here|||weeks||Full Range|Median
1367211|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367212|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367213|NCT01599806|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
1367214|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367215|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367216|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
1367217|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367263|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
1367218|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367219|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367220|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367221|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367222|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367223|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
1367224|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367225|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
1367226|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
1367227|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367228|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
1367229|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367230|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367231|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367232|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
1367233|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367234|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
1367235|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
1367236|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367237|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
1367238|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367239|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367240|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367241|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)|||Participants|||Number
1367242|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
1367243|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
1367244|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367245|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
1367246|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
1367247|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367248|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
1367249|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
1367250|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1368046|NCT01590563|Secondary|Occurrence of Malposition, Expulsion.|Expulsion and malposition are established risks involved with IUD use. Occurrence of these risks may drastically reduce effectiveness. It is expected that the IUB(tm) form will reduce these risks.|12 months||||Number of cases|||Number
1367251|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)|||Participants|||Number
1367252|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)|||Participants|||Number
1367253|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))|||Participants|||Number
1367254|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
1367255|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
1367256|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))|||Participants|||Number
1367257|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
1367258|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )|||Participants|||Number
1367259|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
1367260|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367261|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367262|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367264|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
1367265|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participants|||Number
1367266|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
1367267|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participants|||Number
1367268|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
1367269|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367270|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367271|NCT01599806|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367272|NCT01599806|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367273|NCT01599806|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367274|NCT01599741|Secondary|Radiation Dose Measurements: Air Kerma (AK)|"Percentage dose change of ClarityIQ vs. AlluraXper in AK calculated by AK/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.~AK was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.|||percentage of dose change||Standard Deviation|Mean
1367275|NCT01599741|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|"Percentage dose change of ClarityIQ vs. AlluraXper in DAP calculated by DAP/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.~DAP was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.|||percentage of dose change||Standard Deviation|Mean
1367276|NCT01599741|Primary|Image Quality|Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used.|1 Day|All patients with recorded dose information from the system for both DSA runs were used.|||Proportion of images rated equal/better||90% Confidence Interval|Mean
1367309|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|3 month follow up||||units on a scale||Standard Deviation|Mean
1368047|NCT01590563|Primary|Efficacy in Preventing Pregnancy|Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.|12 months||||Number of pregnancies|||Number
1367277|NCT01599650|Secondary|BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)~-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Month 24|Randomized set|||BCVA letters||Standard Deviation|Mean
1367278|NCT01599650|Secondary|The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.|Months 6 and 24||||score on a scale||Standard Deviation|Mean
1367279|NCT01599650|Secondary|The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity & analysis was based on analysis of variance (ANOVA)|Month 12 and Month 24||||microns||Standard Error|Mean
1367280|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.|Month 24||||participants|||Number
1367281|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.|Month 6||||participants|||Number
1367282|NCT01599650|Secondary|The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 & Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).|Baseline, Month 6 and Month 24||||percent patients gaining improvement|||Number
1367283|NCT01599650|Secondary|The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.|Baseline, Month 12 and Month 24|Full Analysis set|||letters||Standard Deviation|Mean
1367284|NCT01599650|Secondary|Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.|From Baseline through Month 6||||letters||Standard Deviation|Mean
1367285|NCT01599650|Secondary|Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group|Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.|Day 1 through Month 23||||treatments||Standard Deviation|Mean
1367286|NCT01599650|Secondary|The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.|Baseline, 24 Months|analysis for change consists of the group that had a baseline and 24 month data point|||letters||Standard Deviation|Mean
1367287|NCT01599650|Primary|Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)~-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Baseline, 6 Months|analysis for change consists of the group that had a baseline and 6 month data point|||letters||Standard Deviation|Mean
1367288|NCT01599637|Secondary|Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment|The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||score||Standard Deviation|Mean
1367289|NCT01599637|Secondary|Skindex-29 by Treatment|The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients’ quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||Score||Standard Deviation|Mean
1367290|NCT01599637|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.|Baseline through Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||Score||Standard Deviation|Mean
1367291|NCT01599637|Secondary|Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment||Day 29 to Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||Percentage of days||Standard Deviation|Mean
1367292|NCT01599637|Secondary|Likert Scale-Physician’s and Patients In-clinic Global Assessment by Treatment|The investigator or the person he or she designated and the patient provided scoring of the patient’s global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient’s condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||score||Standard Deviation|Mean
1367293|NCT01599637|Secondary|Change From Baseline in Urticaria Activity Score (UAS7)|Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data. If the Week 12 value was missing, it was imputed as the last available UAS7 value (LOCF).|||units on a scale||Standard Deviation|Mean
1367294|NCT01599637|Secondary|Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit||Baseline through Day 140|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||IU/mL||Standard Deviation|Mean
1367295|NCT01599637|Secondary|Mean (SD) Serum Free IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||% change||Standard Deviation|Mean
1367296|NCT01599637|Secondary|Mean (SD) Serum Free IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||ng/mL||Standard Deviation|Mean
1367297|NCT01599637|Secondary|Mean (SD) Serum Total IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||Percent Change from Baseline||Standard Deviation|Mean
1367298|NCT01599637|Secondary|Mean (SD) Serum Total IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||ng/mL||Standard Deviation|Mean
1367299|NCT01599637|Secondary|Serum Levels of Omalizumab|Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks|Baseline through Day 85|PK analysis set which included all subjects who received at least one dose of study drug and had evaluable IGE025 concentrations.|||ng/mL||Standard Deviation|Mean
1367300|NCT01599637|Secondary|Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set|The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis|||# positive cells||Standard Deviation|Mean
1367301|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.• FACS parameters: FceRI expression on basophils and IgE bound, FceR2 expression on B cells and IgE bound, and FceRI expression on dendritic cells|||Flourescence units||Standard Deviation|Mean
1367302|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||% out of leukocytes||Standard Deviation|Mean
1367303|NCT01599637|Secondary|Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||ug/mL||Standard Deviation|Mean
1367304|NCT01599637|Secondary|Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit|The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline to Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Day 29 was an optional sampling time point in this paramter. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|||# positive cells||Standard Deviation|Mean
1367305|NCT01599637|Secondary|Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.|||correlation coefficient|||Number
1367306|NCT01599637|Secondary|Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.|||correlation coefficient|||Number
1367307|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis|||IgE positive skin cells||Standard Deviation|Mean
1367308|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis|||FcεRI positive skin cells||Standard Deviation|Mean
1367310|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Midpoint- Week 4||||units on a scale||Standard Deviation|Mean
1367311|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Baseline||||units on a scale||Standard Deviation|Mean
1367312|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|3 month follow up||||units on a scale||Standard Deviation|Mean
1367313|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|Post Treatment- Week 8||||units on a scale||Standard Deviation|Mean
1367314|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome|Midpoint- Week 4||||units on a scale||Standard Deviation|Mean
1367315|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|3 month follow up|Adverse event data is recorded in adverse event section|||participants|||Number
1367316|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 8|Adverse event data recorded in adverse event section|||participants|||Number
1367317|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 7|adverse events are reported in adverse event section|||participants|||Number
1367318|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 6|adverse events are reported in the adverse event section|||participants|||Number
1367319|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 5|adverse events are reported in adverse event section|||participants|||Number
1367320|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 4|Adverse Event data recorded in Adverse event section|||participants|||Number
1367321|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 3|adverse event data reported in adverse event section|||participants|||Number
1367322|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 2|adverse event data reported in adverse event section|||participants|||Number
1367323|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 – 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|Baseline||||units on a scale||Standard Deviation|Mean
1367324|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 1|AE data reported in adverse events section|||participants|||Number
1367325|NCT01599585|Primary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Post treatment - Week 8||||units on a scale||Standard Deviation|Mean
1367326|NCT01599325|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1367327|NCT01599325|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||Liters/hours||Geometric Coefficient of Variation|Geometric Mean
1367328|NCT01599325|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
1367329|NCT01599325|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||hours||Full Range|Median
1367330|NCT01599325|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1367331|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1367332|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation will be performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ will not be reported|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1367333|NCT01599325|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A treatment-emergent adverse events (TEAE) was defined as AEs with an onset date on or after the date of first dose and within 28 days after the date of the last dose. Any AE that occurred beyond this timeframe and was assessed by the investigator as possibly related to study drug was considered treatment-emergent. The intensity and severity of AEs was assessed by the investigator according to the Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. For any AEs not listed in the CTCAE grading system, the intensities of these events was assessed by the Investigator using the 5-point scale: Grade 1 = Mild, Grade 2 = Moderate; Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. An SAE is any AE occurring that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and constitutes an important medical event.|Up to 29 January 2015; from the first dose of study drug to 28 days after the date of the last dose of study drug (maximum time on study was 244 days)|Safety population included all participants who received at least one dose of azacitidine and had at least one post-dose safety assessment|||participants|||Number
1367334|NCT01599325|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|Overall survival is defined as time to death from any cause, is calculated using date of first dose and date of death, or date of last follow-up for censored participants. Those, who die regardless of the cause of death, will be considered to have an event.|Until the end of the survival follow-up period; Up to data cut-off of 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||months||95% Confidence Interval|Number
1367335|NCT01599325|Secondary|The Number of Infections (Post-baseline Average) Requiring Intravenous (IV) Antibiotics, Anti-fungals, or Antivirals by Cycle|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||Infections||Standard Deviation|Mean
1367351|NCT01599234|Primary|Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)|"The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1367336|NCT01599325|Secondary|The Number of RBC Transfusions by Cycle|The number of RBC transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||RBC Transfusions||Standard Deviation|Mean
1367337|NCT01599325|Secondary|The Number of Units of Red Blood Cell (RBC) Transfusions by Cycle|The number of units of RBC received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for RBC. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|ITT includes all participants who were enrolled into the study|||Units of RBC Transfusions||Standard Deviation|Mean
1367338|NCT01599325|Secondary|The Number of Platelet Transfusions by Cycle|The number of platelet transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||Platelet transfusions||Standard Deviation|Mean
1367339|NCT01599325|Secondary|The Number of Units of Platelet Transfusions by Cycle|The number of units of platelet transfusions received 56 days prior to treatment, considered the baseline period, (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||Units of platelet transfusions||Standard Deviation|Mean
1367340|NCT01599325|Primary|Percentage of Participants Achieving a Hematologic Improvement (HI) Based on 2000 IWG Response Criteria for MDS and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic improvements (HI) have 4 categories: 1. Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor: 10-20g/L increase or ≥50% decrease in transfusion requirements. 2. Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor: ≥50% increase. 3. Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor: ≥100% increase and absolute increase of <0.5x10^9/L 4. Progression or relapse after HI Hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor's determination was derived using clinically relevant data. Denominator for progression/relapse after HI included participants who had achieved HI.|Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
1367341|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Using IWG Criteria for MDS and Assessed by the Investigator|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
1367352|NCT01599104|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|8 weeks|Safety Set. The safety set included aqll participants who had received study medication.|||Participants|||Number
1367353|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure|Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
1367342|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Based on the International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
1367343|NCT01599234|Secondary|Number of Subjects With a 50% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 50% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 50% level is presented."|0 - 15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1367344|NCT01599234|Secondary|Change From Baseline in the Mean Total Barthel Activities of Daily Living Index Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The scores for each of the items are summed to create a total score of 100. An increase in score indicates an improvement.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1367345|NCT01599234|Secondary|Carer Global Impression of Change at the End of Treatment|The carer of the subject gave their opinion of any noticeable change in the subject’s overall functional ability at the end of the study. A 7-point Likert-type scale was used, with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of carers who reported an improvement at the end of treatment is presented.|Day 99 (end of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set as a result of no on-treatment efficacy data|||participants|||Number
1367346|NCT01599234|Secondary|Change From Baseline in Mean Timed 10 Metre Walk Time at the End of Treatment|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||time (seconds)||Standard Deviation|Mean
1367347|NCT01599234|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced and adverse event during the course of the study is presented|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set (used for the efficacy analysis) as a result of no on-treatment efficacy data|||participants|||Number
1367348|NCT01599234|Secondary|Change From Baseline in Mean Sleep Quality 0-10 NRS During the Last 14 Days of Treatment (End of Treatment)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate how your spasticity disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1367349|NCT01599234|Secondary|Change From Baseline in the Mean Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1367350|NCT01599234|Secondary|Number of Subjects With a 30% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 30% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 30% level is presented."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1368635|NCT01584388|Secondary|Retreatment With Rituximab for Disease Relapse|Number of subjects that relapsed during the course of the trial|12 months||||Participants|||Count of Participants
1367354|NCT01599104|Secondary|Change From Baseline in Office Pulse Pressure|Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||mmHg||Standard Error|Least Squares Mean
1367355|NCT01599104|Secondary|Change From Baseline in maSBP and maDBP for Daytime/Nighttime|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
1367356|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
1367357|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msDBP Response|Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||Percentage of participants|||Number
1367358|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msSBP Response|Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||Percentage of participants|||Number
1367359|NCT01599104|Secondary|Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||Percentage of participants|||Number
1367360|NCT01599104|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||mmHg||Standard Error|Least Squares Mean
1367361|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8|Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
1367362|NCT01599104|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
1367363|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set|||Percentages|||Number
1367364|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set|||Percentages|||Number
1367365|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set|||Percentages|||Number
1367382|NCT01598662|Primary|IUD Expulsion Rate|The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.|6 months|No subject in group completed 6 week visit.|||Participants|||Count of Participants
1367366|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set|||Percentages|||Number
1367367|NCT01598987|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 24|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 24.|Baseline, Month 24|Full analysis set|||mL/min/1.73m2||Standard Deviation|Mean
1367368|NCT01598987|Secondary|Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints|"The proportion of patients with composite efficacy failure (treated biopsy proven acute rejection[tBPAR], graft loss [GL] , death [D]) before/at Month 12 and Month 24, estimated with Kaplan-Meier (KM) methods and the proportion of patients who experienced any of the components of composite efficacy failure (tBPAR, GL, D) before/at Month 12 and Month 24, separately for each component.~AR: acute rejection; BPAR: biopsy proven acute rejection. Rate = Kaplan-Meier estimate for failure in %; CI = confidence interval for failure rate."|At 12-month and 24-month after start of study drug|Full Analysis Set|||Percentages||80% Confidence Interval|Number
1367369|NCT01598987|Primary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 12|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.|Baseline, Month 12|Full Analysis Set|||mL/min/1.73m^2||Standard Deviation|Mean
1367370|NCT01598896|Secondary|Change in Craving Symptoms From Baseline at 14 Weeks|"Scores on the Marijuana Craving Questionnaire (Heishman et al. 2009) - The 4 Factor Total Score~Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject."|At 14 weeks|Only 1 placebo subject completed Week 14 of the study and had Week 14 MCQ Total Score data.|||score on MCQ Total 4 Factor scale||Standard Deviation|Mean
1367371|NCT01598896|Secondary|Change From Baseline in Cannabis Use at 14 Weeks|Self-report cannabis use at 14 weeks after initiating the study.|At 14 weeks|Only 1 of the placebo subjects had week 14 data due to the other week 10 completer not attending the follow-up visit at week 14.|||hits/day||Standard Deviation|Mean
1367372|NCT01598896|Secondary|Change in Craving Symptoms From Baseline at 10 Weeks|"Scores on the Marijuana Craving Questionnaire (MCQ) (Heishman et al. 2009) - The 4 Factor Total Score.~Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject."|At 10 weeks|Only 2 of the placebo subjects completed week 10 and had MCQ scores for Week 10.|||score on a MCQ 4 Factor Total scale||Standard Deviation|Mean
1367373|NCT01598896|Primary|Change From Baseline in Cannabis Use at 10 Weeks|Subject self-report hits of marijuana per day at week 10|At 10 weeks|Only 2 of the 4 placebo subjects had Week 10 data due to dropping out of the study.|||hits/day||Standard Deviation|Mean
1367374|NCT01598779|Primary|Human Papillomavirus (HPV) Types in External Genital Warts (EGW)|150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type|4 months|Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, All biopsies were analyzed to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.|||percentage of participants|||Number
1367375|NCT01598740|Secondary|Change in Fecal Weight|Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)||||grams||Standard Deviation|Mean
1367376|NCT01598740|Primary|Change in Fecal Sodium Content|Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)||||mg||Standard Deviation|Mean
1367377|NCT01598701|Secondary|Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria||From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes|The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.|||minutes||Standard Deviation|Mean
1367378|NCT01598701|Secondary|Time to Extubation at Emergence From Anesthesia||Time from of discontinuation of anesthetic to time of extubation, an average of 7 minutes|The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.|||minutes||Inter-Quartile Range|Median
1367379|NCT01598701|Secondary|Post-Operative Side Effects|Patients will be monitored for 24 hours post-operatively to detect the incidence of any drug or opioid-related side effects. These side effects were not considered to be adverse events.|24 Hours Post-Operatively|The # analyzed does not match the # who completed or the overall # analyzed because data on all side effects was not collected for all participants who completed, either due to lack of collection of data by research/nursing staff (for emesis) or due to lack of reporting by participants on a questionnaire(for itching, dizziness, and drowsiness).|||Participants|||Count of Participants
1367380|NCT01598701|Secondary|Post-Operative Pain|Patients will be assessed for pain using a Visual Analogue Scale (VAS) Scale at set time points after surgery (0,1,2,4,8,12,16,20,24 hours post-operatively). The Visual Analogue Scale (VAS) scale was measured on a scale of 0 - 10 (0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Higher values on the VAS represent a worse outcome. The two rows below report: 1. the average VAS score for the least amount of pain reported per group and 2. the average VAS score of the worst amount of pain reported per group.|24 Hours Post-Operatively||||units on a scale||Standard Deviation|Mean
1367381|NCT01598701|Primary|Post-Operative Opioid Requirement|Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs.|24 hours post-operatively||||Morphine Equivalents||Inter-Quartile Range|Median
1367383|NCT01598610|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|Per protocol|||participants|||Number
1367384|NCT01598610|Secondary|Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|217 (220-3) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 1 subject.|||percentage of BG Test Results|||Number
1367385|NCT01598610|Secondary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma) of the reference method results.|1 hour|108 (110-2) blood test results from one test strip lot were analyzed. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick result was obtained for 1 subject.|||percentage of BG Test Results|||Number
1367386|NCT01598610|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Venipuncture was unsuccessful for 6 subjects. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method.|||percentage of BG Test Results|||Number
1367387|NCT01598610|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Four(4) subjects had low blood sugar and AST results were not evaluable per protocol. One(1) subject with low blood sugar (AE) did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.|||percentage of BG Test Results|||Number
1367388|NCT01598610|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|216 (220-4) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 2 subjects.|||percentage of BG Test Results|||Number
1367389|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|24 hours after intrathecal injection||||units on a scale||Full Range|Mean
1367390|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|18 hours after intrathecal injection||||units on a scale||Full Range|Mean
1367391|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|6 hours after intrathecal injection||||units on a scale||Full Range|Mean
1367392|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline||||units on a scale||Full Range|Mean
1367393|NCT01598545|Primary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|12 hours after intrathecal injection||||units on a scale||Full Range|Mean
1367394|NCT01598532|Primary|Digit Span, Forwards and Backwards|Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group|||# of SD units||Standard Deviation|Mean
1367395|NCT01598532|Primary|Controlled Oral Word Association Test (FAS)|Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group|||# of SD units||Standard Deviation|Mean
1367396|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in Transcranial LED Treatment Group|||# of SD Units||Standard Deviation|Mean
1367397|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5|California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment|All participants enrolled in Real Intervention Group|||# of SD Units||Standard Deviation|Mean
1367398|NCT01598532|Primary|Stroop Test for Executive Function - Trial 4 Inhibition Switching|Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment|All participants enrolled in Transcranial LED Treatment Group|||# of SD Units||Standard Deviation|Mean
1367399|NCT01598532|Primary|Stroop Test for Executive Function - Trial 3 - Inhibition|Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-month and 2-months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group|||# of SD units||Standard Deviation|Mean
1367400|NCT01598506|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline||||units on a scale||Full Range|Mean
1367401|NCT01598506|Primary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|30 minutes after intrathecal injection||||units on a scale||Full Range|Mean
1367402|NCT01598428|Secondary|Refractive Error|auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively||||diopter(D)|Participants|Standard Deviation|Mean
1367403|NCT01598428|Secondary|Uncorrected Visual Acuity(UCVA)|The UCVA was recorded in logMAR units at each vist|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively||||logMAR|Participants|Standard Deviation|Mean
1367404|NCT01598428|Primary|Effective Lens Position|Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.|1 day，1 week, 1 month，3 months and 6 months postoperatively||||mm|Participants|Standard Deviation|Mean
1367405|NCT01598350|Primary|Step Width||60 minutes||||cm||Standard Deviation|Mean
1367406|NCT01598311|Primary|Percentage of Participants Discontinuing From Study Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.|Up to EOT (up to Day 10)|The analysis population consists of all randomized and treated participants (Safety Population).|||Percentage of Participants|||Number
1367407|NCT01598311|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.|Up to 30 days after EOT (up to Day 40)|The analysis population consists of all randomized and treated participants (Safety Population).|||Percentage of Participants|||Number
1367408|NCT01598311|Secondary|Adjusted Percentage of Participants With Sustained Clinical Response at End of Study|The percentage of participants with sustained clinical response was determined for each arm. Sustained clinical response was declared when participants had a clinical outcome of cure at EOT, did not experience any CDAD recurrence, did not die, were not lost to follow-up, and did not have the end of study visit prior to Day 40. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.|Up to 40 days after EOT (up to Day 50)|The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).|||Adjusted percentage of participants||95% Confidence Interval|Number
1367409|NCT01598311|Secondary|Number of Clinical Failure Events up to Day 40|The total number of clinical failure events, which included treatment failure, CDAD recurrence, death, or being lost to follow-up, occurring during each time period was determined in each arm.|Up to 30 days after EOT (up to Day 40)|The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).|||Number of Failure Events|||Number
1367410|NCT01598311|Primary|Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)|"The percentage of participants considered cured (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or >200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage."|Up to 3 days after EOT (up to Day 13)|The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).|||Adjusted percentage of participants||95% Confidence Interval|Number
1367411|NCT01598298|Secondary|Pain Interference According to the BPI-SF|Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating “Does not interfere” and 10 indicating “Completely interferes”.|Weeks 2, 6, 12, and 24; Week 12 reported|Patients evaluable for primary endpoint|||units on a scale||Standard Deviation|Mean
1367412|NCT01598298|Secondary|Worst Joint Pain According to the BPI-SF|Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating “No pain” and 10 indicating “Pain as bad as you can imagine”.|Weeks 2, 6, 12, and 24; Week 12 reported|Patients evaluable for primary endpoint|||units on a scale||Standard Deviation|Mean
1367413|NCT01598298|Primary|Average Joint Pain According to BPI-SF|Average joint pain according to the Brief Pain Inventory – Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating “No pain” and 10 indicating “Pain as bad as you can imagine”.|Weeks 2, 6, 12, and 24; Week 12 reported|Patients evaluable for primary endpoint|||units on a scale||Standard Deviation|Mean
1367414|NCT01598207|Secondary|Sensory Thresholds for Pain|When highest amount of pain was felt; range is 0-65 mmHg|Baseline and 1 month|1 participant in marinol and 1 participant in placebo did not have this information completed|||mmHg||Standard Deviation|Mean
1367415|NCT01598207|Secondary|Sensory Thresholds for Discomfort|When participants felt pain at earliest pressure; range 0-65 mmHg|Baseline and 1 month|1 participant in marinol and 1 participant in placebo did not have this information completed|||mmHg||Standard Deviation|Mean
1367416|NCT01598207|Secondary|Duration of Chest Pain Episodes|0 - is none and 3 is longer than 30 mins; higher values is worst outcome; chest pain totals are averaged|Baseline vs 1 month|1 participant in placebo did not have this information completed|||units on a scale||Standard Deviation|Mean
1367417|NCT01598207|Secondary|Sensory Thresholds for First Sensation|This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg|Baseline and 1 month||||mmHg||Standard Deviation|Mean
1367418|NCT01598207|Secondary|Intensity of Chest Pain Episodes|Intensity (0(none) - 3(severe)) at baseline vs 1 month for chest pain episodes; higher represents worse outcome; multiple chest pain totals are averaged|Baseline and 1 month|1 participant in placebo did not have this information completed|||units on a scale||Standard Deviation|Mean
1367419|NCT01598207|Secondary|Frequency of Chest Pain in Treatment Group vs Baseline|Total (intensity (0(none) - 3(severe) + duration (0(none) - 3(longer than 30 mins)) at end of 1 month treatment; higher represents worse outcome; the total score ranges from 0 to 6 and is the sum of the intensity and duration|1 month|1 participant in placebo did not have this information completed|||units on a scale||Standard Deviation|Mean
1367420|NCT01598207|Primary|Frequency of Chest Pain Episodes|Number of people still experiencing the same amount of chest pain during treatment than previously without|Baseline and 1 month||||participants|||Number
1367421|NCT01598129|Primary|Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities|No Dose Limiting Toxicities were observed at any dose level.|6 months||||Dose limiting toxicities|||Number
1367422|NCT01598129|Other Pre-specified|Number of Patients With Induction of Tumor-specific CD8+ T Cells in Peripheral Blood Monomuclear Cells.||6 months||||participants|||Number
1367423|NCT01598129|Other Pre-specified|Number of Participants With Infiltration of CD8+ T Cells Into Tumors.||6 months||||participants|||Number
1367424|NCT01598129|Other Pre-specified|An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.||6 hours||||participants|||Number
1367425|NCT01598129|Other Pre-specified|Quality of Life Using EORTC QLQ-C30.|To assess the feasibility and usefulness of EORTC QLQ-C30 for possible use in later studies.|12 months|||||||
1367426|NCT01598129|Other Pre-specified|Number of Participants With Stable Disease Status as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Evaluation Three Months After Starting CGTG-102 Treatment.||3 months||||participants|||Number
1367427|NCT01598129|Secondary|To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.|Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.|12 months|||||||
1367428|NCT01598129|Primary|Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.||6 months||||participants|||Number
1367429|NCT01598064|Secondary|Liver Function Evaluation|Measure ALT level of patients|8 weeks||||U/L||Standard Deviation|Mean
1367430|NCT01598064|Primary|Admission Due to Complications Related to Portal Hypertension||8 weeks||||participants|||Number
1367431|NCT01598025|Secondary|Evaluation of Recipients Post Transplant|The levels of engraftment and persistence of hematopoietic cells and their myeloid and lymphoid progressing from each donor post transplant. The tolerance or reactivity of engrafted T cells from each donor detected in the blood at 3, 6, and thereafter every 3-6 months until normal, post transplant against host cells and cells derived from the other parent as measured by standard mixed lymphocyte culture and cell mediated cytolysis assays.|1 year|Due to the small accrual on study, as well as patient course following treatment on study, the primary objectives of this study were not able to be analyzed.||||||
1367432|NCT01598025|Primary|Efficacy of HLA-haploidentical Biparental T-cell Depleted CD34+ Peripheral Blood Stem Cell Transplants|"Efficacy is measured by:~incidence of transplant-related mortality, overall survival and disease-free survival at 1 year post transplant.~incidence, tempo and complications of engraftment and hematopoietic reconstitutions and conversely, the risk of graft failure~incidence and severity of acute and/or chronic GVHD~incidence and severity of opportunistic infections developing following engraftment"|1 year|Due to the small accrual on study, as well as patient course following treatment on study, the primary objectives of this study were not able to be analyzed.||||||
1367433|NCT01597908|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data are summarized per RECIST, Version 1.1.|From the first documented evidence of a CR or PR until the earliest date of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Only those participants with a confirmed response (CR and PR) were analyzed. Participants with measurable and non-measurable disease were analyzed.|||Months||95% Confidence Interval|Median
1367571|NCT01596504|Secondary|Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast.|Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||participants|||Number
1367434|NCT01597908|Secondary|Overall Response, as Assessed by the Investigator|Overall response is defined as the number of responders (complete response [CR] + partial response [PR] per RECIST, Version 1.1) as summarized by Investigator assessment. CR is defined as the disappearance of all evidence of target lesions. PR is defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data are reported as those participants with measureable disease.|Screening, Week 8 and every 8 weeks thereafter through Week 56, and then every 12 weeks|ITT Population|||Participants|||Number
1367435|NCT01597908|Secondary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|From randomization to the first documented occurrence of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Participants who did not progress or die or who progressed or died after the start of new anti-cancer therapy or after an extended period without adequate assessment were censored at their date of last adequate assessment prior to progression or death even if subsequent information was available regarding progression or death.|||Months||95% Confidence Interval|Median
1367436|NCT01597908|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death due to any cause (up to Study Week 92)|Intent-to-Treat (ITT) Population: all randomized participants, whether or not study medication was administered. All participants in the ITT Population were analyzed. For participants who did not die, time of death was censored at the date of last contact.|||Months||95% Confidence Interval|Median
1367437|NCT01597843|Primary|Registration for MHV|Measured by response to question: Have you ever used My HealtheVet online?|Baseline; After Group 1 Intervention; After Group 2 Intervention|Respondents to first round survey|||Percentage of respondents who use MHV|||Number
1367438|NCT01597791|Primary|Number of Participants With Positive Urine Culture|This study will be assessed by collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine culture. The clinical and laboratory criteria used to define a urinary tract infection.|48 Hours||||participants with positive urine culture|||Number
1367439|NCT01597635|Secondary|Immunogenicity Assessment With Respect to Anti-ACE2 Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part B)|Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.|Follow-up (Day 14 )and follow-up (Day 28)|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1367440|NCT01597635|Secondary|Immunogenicity Assessment With Respect to Anti-Acetychollinesterase2 (ACE2) Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part A)|Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.|Follow-up (Day 14) and follow-up (Day 28)|The All Subjects – Part A Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1367441|NCT01597635|Secondary|Biomarker Analysis for Markers of Lung Epithelial Cell Injury Clara Cell Protein 16 [CCP16]) and Surfactant Protein D [SP-D] Upto Day 5 (Part B)|Markers of lung epithelial cell injury included CCP16 and SP-D. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||95% Confidence Interval|Median
1367442|NCT01597635|Secondary|Biomarker Analysis for Serum Inflammatory Biomarker C-reactive Protein (CRP) Upto Day 5 (Part B)|Serum inflammatory biomarker included CRP. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||milligrams per deciliter||95% Confidence Interval|Median
1367443|NCT01597635|Secondary|Biomarker Analysis for Serum Inflammatory Biomarkers, Markers of Neutrophil Activation, Markers of Lung Epithelial Cell Injury, Renin Levels and Aldosterone Levels Upto Day 5 (Part B)|Serum inflammatory biomarkers included CXCL-8 [IL-8], IL-6, markers of neutrophil activation included (e.g. myeloperoxidase [MPO]), markers of lung epithelial cell injury included receptor for advanced glycation end-products [RAGE], Angiopoietin 2, along with rennin, aldosterone levels. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter||95% Confidence Interval|Median
1367601|NCT01595646|Secondary|Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio|CSF Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject. A pre and post ratio of TTau-P181/Abeta42 will be given.|Change from Baseline in CSF Biomarkers at 16 Weeks||||ratio||Standard Deviation|Mean
1367444|NCT01597635|Secondary|Evaluation of Sequential Organ Failure Assessment (SOFA) Score on Day 4 and Day 7 (Part B)|The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). The score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.|Day 4 and Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Score on scale||95% Confidence Interval|Mean
1367445|NCT01597635|Secondary|Number of Participants With Acute Kidney Injury as Defined by Day 1 to Day 3 Change in Risk, Injury, Failure, Loss of Kidney Function, and End-stage Kidney Disease (RIFLE) Criteria Upto Day 3 (Part B)|The RIFLE score is made up of the glomerular filtration rate criteria (GFRC) and urine output criteria (UOC) and is defined as Risk (Serum Creatinine x 1.5 or GFR decrease > 25%-GFRC and < 0.5 milliliter/kilograms/hour [ml/kg/hour] x 6 hours-UOC), Injury (Serum Creatinine x 2 or GFR decrease > 50%-GFRC and < 0.5 ml/kg/hour x 12 hours), Failure (Serum Creatinine x 3, or GFR decrease > 75% [F=Failure] or Serum Creatinine >=4 milligrams/deciliter [mg/dl] with an acute rise > 0.5 mg/dl [Fc=Failure acute on chronic] and < 0.3 ml/kg/hour x 24 hours, or anuria x 12 hours [Fo=Failure oligouria]). Due to the duration of this study it was not possible to be calculate the designated RIFLE class Loss and RIFLE class End-stage kidney disease. Data has been presented for rifle score total, rifle score GFR and rifle score urine. Abbreviations NAKI= No acute kidney injury, R=risk, I=injury, MISS= Unable to derive score.|Upto Day 3|The All Subjects – Part B Population.|||Participants|||Number
1367446|NCT01597635|Secondary|Measure of Oxygenation Index Upto Day 7 (Part B)|Oxygenation index was defined as calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body and was computed using the equation Oxygenation Index= FiO2 x Mean Airway Pressure/Pao2. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Percentage||95% Confidence Interval|Median
1367447|NCT01597635|Secondary|Measure of Oxygenation Including Fraction of Inspired Oxygen/ Partial Pressure of Oxygen in Arterial Blood (PaO2/FiO2) Ratio Via Pulse Oximetry Upto Day 7 (Part B)|"Measure of oxygenation included PaO2/FiO2 ratio defined as the ratio of arterial oxygen partial pressure to fractional inspired oxygen by pulse oximeter a device that measured the oxygen saturation of arterial blood in a participant by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries.~Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval."|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Median
1367448|NCT01597635|Secondary|Measures of Oxygenation Including Level of Positive End Expiratory Pressure (PEEP), Peak Ventilatory Pressures and Plateau Ventilatory Pressures Upto Day 7 (Part B)|Measures of oxygenation included PEEP the pressure in the lungs (alveolar pressure) above atmospheric pressure (the pressure outside of the body) that exists at the end of expiration, peak ventilator pressure highest level of pressure applied to the lungs during inhalation and plateau ventilatory pressure the pressure applied to small airways and alveoli measured during an inspiratory pause on the ventilator. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||centimeters of water pressure||90% Confidence Interval|Median
1367449|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/Ang (1-5) and Ang II/Ang (1-7) Upto Day 5(Part B)|Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-5) and Ang II/Ang (1-7) and). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Median
1367450|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II, Ang (1-7) and Ang (1-5) Upto Day 5(Part B)|Renin-angiotensin system cascade biomarkers included Ang II, Ang (1-7) and Ang (1-5). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter||95% Confidence Interval|Median
1367451|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/ Ang (1-7) Upto Day 2 (Part A)|Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours on Day 1 and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).|All Subjects – Part A Population.|||Ratio||95% Confidence Interval|Geometric Mean
1377681|NCT01478971|Primary|Percentage of Participants Undergoing Conversion to Peginesatide Injection||6 months|All participants who received at least one dose of study treatment.|||percentage of participants|||Number
1367452|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Angiotensin (Ang) II and Ang (1-7) Upto Day 2 (Part A)|Renin-angiotensin system cascade biomarkers included Ang II and Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).|All Subjects – Part A Population|||picograms per milliliter||95% Confidence Interval|Geometric Mean
1367453|NCT01597635|Secondary|Analysis Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part B)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.|Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours|Pharmacokinetic - Part B Population.|||liters per hour||Standard Error|Geometric Mean
1367454|NCT01597635|Secondary|Analysis of Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part A)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.|Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours|Pharmacokinetic - Part A Population.|||liters per hour||Standard Error|Geometric Mean
1367455|NCT01597635|Secondary|Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part B)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part B.|Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3)|The Pharmacokinetic - Part B Population was defined as participants in the All Subjects – Part B population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881. Only those participants with data available at the indicated time points were analyzed.|||nanograms per milliliter||Standard Deviation|Mean
1367456|NCT01597635|Secondary|Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part A)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part A|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2)|The Pharmacokinetic - Part A Population was defined as participants in the All Subjects – Part A population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881.|||nano grams per milliliter||Standard Deviation|Mean
1367457|NCT01597635|Primary|Number of Par With AE and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part B)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Day 7|All Subjects – Part B Population.|||Participant|||Number
1367458|NCT01597635|Primary|Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part A)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Day 7|The All Subjects – Part A Population was defined as all participants in Part A who received at least one dose of study medication.|||Participants|||Number
1367459|NCT01597635|Primary|Clinical Chemistry Parameters Albumin and Total Protein Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included albumin and total protein. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
1367460|NCT01597635|Primary|Clinical Chemistry Parameters Alkaline Phosphatase, Asparatate Amino Transferase, Alanine Amino Transferase, Gamma Glutamyl Transferase Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included alkaline phosphatase, asparatate amino transferase, alanine amino transferase, gamma glutamyl transferase. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||International units per liter||Standard Deviation|Mean
1367461|NCT01597635|Primary|Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included direct bilirubin, total bilirubin, creatinine and uric acid. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||micromoles per liter||Standard Deviation|Mean
1367462|NCT01597635|Primary|Clinical Chemistry Parameters Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included calcium, chloride, carbon dioxide, glucose, potassium, sodium, Urea/Blood urea nitrogen. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||millimoles per liter||Standard Deviation|Mean
1367463|NCT01597635|Primary|Hematology Parameter Hematocrit Assessment Upto Day 7 (Part B)|Hematology parameter included hematocrit. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
1367464|NCT01597635|Primary|Hematology Parameter Mean Corpuscle Hemoglobin (MCH) Assessment Upto Day 7 (Part B)|Hematology parameter included MCH. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||picograms||Standard Deviation|Mean
1367465|NCT01597635|Primary|Hematology Parameter Mean Corpuscle Volume (MCV) Assessment Upto Day 7 (Part B)|Hematology parameter included MCV. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||femtoliters||Standard Deviation|Mean
1367466|NCT01597635|Primary|Hematology Parameter Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Assessment Upto Day 7 (Part B)|Hematology parameters included hemoglobin and MCHC. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
1367467|NCT01597635|Primary|Hematology Parameters Red Blood Cell Count and Reticulocyte Count Assessment Upto Day 7 (Part B)|Hematology parameters included red blood cell count and reticulocyte count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||trillion cells per liter||Standard Deviation|Mean
1367468|NCT01597635|Primary|Hematology Parameters Basophils, Eosinophil, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count Upto Day 7 (Part B)|Hematology parameters included basophils, eosinophil, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||giga per liter||Standard Deviation|Mean
1367469|NCT01597635|Primary|Electrocardiogram (ECG) Parameters, Including PR, QRS, QT, and QTCU and RR Intervals Upto Day 7 (Part B)|Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTCU and RR intervals. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||millisecond||Standard Deviation|Mean
1367470|NCT01597635|Primary|Diastolic and Systolic Blood Pressure Assessments Upto Day 7 (Part B)|Vital sign included systolic blood pressure and diastolic blood pressure. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Millimeters of merucry||Standard Deviation|Mean
1367471|NCT01597635|Primary|Heart Rate Assessments Upto Day 7 (Part B)|Vital sign included heart rate. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.|Up to Day 7|The All Subjects – Part B Population was defined as all participants in Part B who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1367472|NCT01597596|Secondary|Change From Baseline in Motor Development Status at Week 52|Motor development status was assessed by the Gross Motor Function Measure - 88 Scale (GMFM-88) total percent scores. GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item was scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension was expressed as a percentage of the maximum score for that dimension. Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision.|||percentage of maximum total score||Standard Deviation|Mean
1367473|NCT01597596|Secondary|Number of Participants With Invasive Ventilator-Free Survival|Invasive ventilator-free survival was defined as the time during which the participant is alive and not invasively ventilated. Number of Participants with invasive ventilator-free survival were reported.|Up to Week 52|Full analysis population.|||participants|||Number
1367474|NCT01597596|Secondary|Percentage of Participants With Estimated Probability of Survival||Up to Week 52|Full analysis population.|||percentage of participants|||Number
1367475|NCT01597596|Primary|Change From Baseline in Cardiac Function at Week 52|Cardiac function was measured by the left ventricular mass Z-score (LVM-Z). Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline indicates an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population defined as all participants who receive at least 1 infusion of alglucosidase alfa. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision|||Z-score||Standard Deviation|Mean
1367476|NCT01597505|Secondary|Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study|Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. Only the first failure event per participant was counted. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|The Per Protocol 2 (PP2) population composed of cures and failures from the PP1 population. Additionally, to be included in the PP2 population, PP1 participants who were cured at end of treatment must not have had any protocol deviations which could affect the assessment of recurrence and have had follow-up contact through at least Day 40.|||Percentage of participants||95% Confidence Interval|Number
1367477|NCT01597505|Secondary|Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline|Sustained clinical response at the end of study was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who had a clinical outcome of cure at the end of treatment (Day 13) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|All randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline|||Percentage of participants||95% Confidence Interval|Number
1367478|NCT01597505|Secondary|Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment|Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 13|The population analyzed is the Per Protocol 1 (PP1) population composed of participants from the mMITT population, according to the actual treatment they received; without any protocol deviations from enrollment through 2 days after end of treatment, which could affect the efficacy conclusions.|||Percentage of participants||95% Confidence Interval|Number
1367479|NCT01597505|Secondary|Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline|Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 13|Randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline.|||Percentage of participants||95% Confidence Interval|Number
1367480|NCT01597505|Secondary|Time to Reappearance of Diarrhea From End of Treatment to the End of Study|Time to reappearance of diarrhea with >= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured at end of treatment.|Up to Day 50|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and were cured at end of treatment.|||Days||95% Confidence Interval|Median
1367481|NCT01597505|Secondary|Time to Resolution of Diarrhea|Time to resolution of diarrhea with =< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug.|Up to Day 13|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized|||Days||95% Confidence Interval|Median
1367482|NCT01597505|Secondary|Adjusted Percentage of Participants With Recurrence of CDAD at End of Study|Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1367483|NCT01597505|Secondary|Adjusted Percentage of Participants With Sustained Clinical Response at Day 24|Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Day 24|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1367484|NCT01597505|Primary|Percentage of Participants Who Discontinued Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).|Up to Day 13|All randomized participants who received any amount of study drug|||Percentage of participants|||Number
1367602|NCT01595646|Secondary|Cerebral Spinal Fluid (CSF) Biomarkers of AD|CSF Abeta (Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.|Change from Baseline in CSF Biomarkers at 16 Weeks||||pg/mL||Standard Deviation|Mean
1367485|NCT01597505|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE)|A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.|Up to Day 50|All randomized participants who received any amount of study drug|||Percentage of participants|||Number
1367486|NCT01597505|Primary|Percentage of Participants With at Least One Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).|Up to Day 50|All randomized participants who received any amount of study drug|||Percentage of participants|||Number
1367487|NCT01597505|Secondary|Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study|Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1367488|NCT01597505|Secondary|Number of Participants With Clinical Response Over Time|Clinical response over time as measured by those without treatment failure, recurrence, death, or lost to follow-up, measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41).|Up to Day 41|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized|||Participants|||Count of Participants
1367489|NCT01597505|Primary|Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)|A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.|Up to 13 days|The population analyzed is the Microbiological Modified Intent-To-Treat (mMITT) population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1367490|NCT01597492|Primary|Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination|A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28.|Four weeks after vaccination|As-treated Population: all participants who received at least one dose of belimumab. All analyses of vaccine titers were performed on the As-treated Population.|||Participants|||Number
1367491|NCT01597479|Secondary|Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron|Number of participants with Maximum pain intensity NVS > 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty|||participants|||Number
1367492|NCT01597479|Primary|Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day|Pain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty (TRA)|||percentage of patients|||Number
1367493|NCT01597440|Secondary|Number of Participants With Adverse Events|Safety is measured by tracking and detailing the number and type of adverse events and their severity based on the CTCAE.|Start of episode through 7 days or discharge (if earlier)||||Participants|||Number
1367494|NCT01597440|Primary|Neurodevelopment|Neurodevelopmental outcome as measured by Cognitive Composite (Bayley III), Motor Composite (Bayley III) and Functional Status Scale and safety of NCG treatment as measured by adverse events and laboratory blood tests|30 months|The study was closed prematurely. There is no analysis population.||||||
1367620|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367495|NCT01597375|Secondary|Change From Baseline in Prostaglandin Metabolites (PGD-M) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks|We will note difference in the Prostaglandin metabolites (PGD-M) measurement obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )|Evaluated at baseline and reported at 8 weeks|This was assessed across all participants with no planned comparisons between placebo and prasugrel.|||ng/mg creatinine||Standard Deviation|Mean
1367496|NCT01597375|Secondary|Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Score After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks|We will note difference in the Asthma Control Questionnaire-7 (ACQ-7) score [ The ACQ has 7 questions on a 7-point scale (minimum score of 0=no impairment, maximum score of 6= maximum impairment)] obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )|Evaluated at baseline and reported at 8 weeks|This was assessed across all participants with no planned comparisons between placebo and prasugrel.|||score on a scale||Standard Deviation|Mean
1367497|NCT01597375|Other Pre-specified|Effect of Prasugrel on Platelet Chemistry in Subjects With AERD During Aspirin Challenge.|To determine if treatment with prasugrel changes the baseline percentages of activated platelets or platelet-leukocyte aggregates or changes the plasma levels of soluble platelet products during clinical reaction to aspirin|Evaluated at visit 2 and 3 (week 8 and 14)|||||||
1367498|NCT01597375|Other Pre-specified|Baseline Differences in Platelet Chemistry in Subjects With AERD Compared to Controls|To determine if there are baseline differences in the percentages of activated platelets, platelet-leukocyte aggregates, or the plasma levels of soluble platelet products in subjects with AERD, compared to aspirin tolerant asthmatics (ATA) and non-asthmatic controls.|Evaluated at visit 1 (week 4)|||||||
1367499|NCT01597375|Secondary|Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks|We will note difference in the fractional exhaled nitric oxide (FeNO) obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )|Evaluated at baseline and reported at 8 weeks|This was assessed across all participants with no planned comparisons between placebo and prasugrel.|||parts per billion||Standard Deviation|Mean
1367500|NCT01597375|Secondary|Change in Urinary LTE4 During Aspirin Challenge on Placebo Versus Prasugrel|We will compare the participant's Leukotriene E4 (LTE4) obtained from the aspirin challenge done after pretreatment with prasugrel, the aspirin challenge done after pretreatment with placebo.|Change from visits 2 at visit 3 (weeks 8, 14), calculated and reported at visit 3||||percentage change from baseline||Standard Deviation|Mean
1367501|NCT01597375|Secondary|Change in Total Nasal Symptom Score(TNSS)From Baseline to Peak During Aspirin Challenge on Placebo Versus Prasugrel.|The primary outcome in Part 1 will be the maximum Total Nasal Symptom Score (TNSS) attained for subjects with AERD during the clinical reaction to aspirin challenge. The primary analysis will compare this outcome within each participant after treatment with prasugrel versus placebo. Nasal symptoms including congestion, rhinorrhea, runny nose, itchy nose, sneezing, itchy eyes, teary eyes, itchy ears/throat, and eye redness were assessed on a 0- to 5-point scale (0, none-5, very severe) in response to the provocative dose of aspirin during aspirin challenge/desensitization and summed together to generate the TNSS score (range 0-40).|Data obtained at visits 2 and 3 (weeks 8 and 14) and change calculated at visit 3||||units on scale||Standard Error|Mean
1367502|NCT01597375|Secondary|Difference in Participant's Provocative Dose of Aspirin When Pretreated With Prasugrel Versus Placebo|We will monitor the dose of aspirin at which the participant shows symptoms (increased discomfort, 15% drop in FEV1) during the aspirin challenge/desensitization. We will compare the provocative aspirin dose obtained from the aspirin challenge occurring after pretreatment with prasugrel to the dose obtained after pretreatment with placebo.|Evaluated at visits 2 and 3 (weeks 8 and 14)||||mg||Standard Error|Mean
1367503|NCT01597375|Primary|Change From Baseline Expression Levels of COX-2 Transcript and Protein in Peripheral Blood Leukocytes of Subjects With AERD After 8 Weeks of Treatment With Aspirin.|This study will compare this outcome within each participant between baseline (established at Visit 1, prior to initiation of prasugrel therapy) and at the completion of 8 weeks of aspirin therapy.|Evaluated at visits 1 and 4 (weeks 4 and 22)|The planned experimental protocol for COX-2 analysis at the lab bench was unsuccessful, therefore no data was collected for this Outcome Measure||||||
1367504|NCT01597375|Primary|Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo|"The PD2 is the provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge. The PD2 is calculated by:~inverse〖log〗_10 (((2-(PrevTNSS-BaselineTNSS))×(〖log〗_10 ProvocDose-〖log〗_10 PrevDose))/((MaxTNSS-BaselineTNSS)-(PrevTNSS-BaselineTNSS) )+(〖log〗_10 PrevDose))"|Difference in PD2 (provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge) between Visits 2 and 3 (weeks 8 and 14), calculated at visit 3||||mg||Standard Error|Mean
1367505|NCT01597245|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the # of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received at least 1 dose of study treatment and had evaluable data.|||percentage of participants|||Number
1367506|NCT01597245|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 75%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps involvement at baseline. Participants who did not meet clinical response criteria or have missing data will be considered non-responders.|||percentage of participants|||Number
1367507|NCT01597245|Secondary|Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. LS mean change from baseline in patient's global assessment of disease severity score was calculated using (MMRM) with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects."|Baseline, 12 weeks|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline PatGA measurement.|||units on a scale||Standard Error|Least Squares Mean
1367508|NCT01597245|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean change from baseline in SF-36 score was calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline SF-36 measurement. Missing data was imputed by last observation carried forward ( LOCF ).|||units on a scale||Standard Error|Least Squares Mean
1367509|NCT01597245|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The (WPAI-PSO) is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days and has four domains, namely, absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as each score * 100 and ranges from 0 to 100; greater scores indicate greater impairment. LS mean change from baseline in each WPAI-PSO score was calculated using the (ANCOVA) model with treatment, pooled center and baseline WPAI value.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline WPAI-PSO measurement. Missing data was imputed by last observation carried forward ( LOCF ).|||units on a scale||Standard Error|Least Squares Mean
1367510|NCT01597245|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean change from baseline in total QIDS-SR16 score was calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline QIDS-SR16 measurement. Missing data was imputed by last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1367511|NCT01597245|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis|The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean change from baseline in BSA was calculated using MMRM with baseline BSA as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.|||units on a scale||Standard Error|Least Squares Mean
1367512|NCT01597245|Secondary|Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 (less severity) to 72 (more severity), with lower scores indicating less severity. LS mean change from baseline in PSSI score was calculated using MMRM with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps involvement at baseline and at least 1 post-baseline PSSI measurement. Missing data was imputed by last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1367513|NCT01597245|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps. The fingernail bed and fingernail matrix are each divided into quadrants. Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. The NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80 with higher scores indicating more severe Ps. LS mean change from baseline in NAPSI score was calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps involvement at baseline and at least 1 post-baseline NAPSI measurement.|||units on a scale||Standard Error|Least Squares Mean
1367514|NCT01597245|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much); and not relevant and unanswered responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life impairment. A 5-point change from baseline is considered clinically relevant. Least Squares (LS) Mean change from baseline was calculated using mixed model repeated measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and who had baseline and at least 1 post-baseline DLQI measurement.|||units on a scale||Standard Error|Least Squares Mean
1367515|NCT01597245|Secondary|Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline|"The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. The number and percentage of participants achieving an Itch NRS ≥4 point reduction from baseline were presented by treatment group for participants who had a baseline Itch NRS ≥4. Describes worst level of itching in past 24 hours."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and had Itch NRS ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1367516|NCT01597245|Secondary|Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|All randomized participants who had sPGA score of (0,1) at Week 12, were re-randomized at Week 12 and received at least 1 dose of study treatment in the Maintenance Dosing Period. Participants who did not meet the clinical response criteria or had missing data at Week 60 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of participants|||Number
1367517|NCT01597245|Secondary|Percentage of Participants Achieving PASI 100% (PASI100)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1367518|NCT01597245|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 were defined as having an improvement of ≥90% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1367519|NCT01597245|Secondary|Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant’s Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1367520|NCT01597245|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1367521|NCT01597245|Primary|Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of “0” or “1” with at least a 2-point improvement from baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1367522|NCT01597141|Secondary|Functioning|Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.|24 months|15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study.|||units on GAF scale||Standard Deviation|Mean
1367523|NCT01597141|Primary|Onset of Psychosis|Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.|From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months||||percentage of sample converting|||Number
1367524|NCT01597128|Primary|Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation|Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.|12 months|Patients with 12 month completion of the SF12|||Normalized scores||Standard Deviation|Mean
1367525|NCT01597128|Primary|Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation|Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.|12 months|Patients with 12 month completion of the SF12|||Normalized scores||Standard Deviation|Mean
1367526|NCT01597128|Primary|Wound Occurrence: Superficial Wound Infection|Superficial wound infection|12 months||||percent of patients|||Number
1367527|NCT01597128|Primary|Wound Occurrence: Wound Dehiscence||12 Months||||percentage of patients|||Number
1367528|NCT01597128|Primary|Wound Occurrence: Wound Cellulitis||12 Months||||percentage of patients|||Number
1367529|NCT01597128|Primary|Wound Occurrence: Wound Seroma||12 Months||||percentage of patients|||Number
1367530|NCT01597128|Primary|Wound Occurrence: Wound Abscess||12 Months||||percentage of patients|||Number
1367531|NCT01597128|Primary|Wound Occurrence: Deep Wound Infection||12 Months||||percentage of patients|||Number
1367532|NCT01597128|Primary|Wound Occurrence|superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.|12 months||||percentage of patients|||Number
1367533|NCT01597128|Primary|Hernia Recurrence|Recurrence of hernia based on physical exam and /or CT scan.|12 months||||percentage of patients|||Number
1367534|NCT01597050|Primary|Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.|Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.|Up to Week 4|Per-protocol population all patients who had no major protocol deviations and were present at all scheduled visits up to and including Week 4.|||percentage of subjects|||Number
1367535|NCT01596972|Secondary|Patient Satisfaction With Each Follow-up Method|"Patient satisfaction with each follow-up method was assessed with the following survey questions:~How satisfied are you with [name of follow-up method]? (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)"|1 week||||participants|||Number
1367536|NCT01596972|Secondary|Patient Compliance With Each Follow-up Method||2 weeks||||participants|||Number
1367537|NCT01596972|Primary|Number of Women in Each Group Who Require a Return Visit to the Clinic for a Serum hCG Measurement, Ultrasound or Clinical Examination at One Week to Confirm Complete Evacuation||1 week|The number of participants analyzed in the serum hCG arm were the number of participants who started in this arm minus the number who were discontinued from the study per MD decision (total N in analysis was therefore 17).|||participants|||Number
1367538|NCT01596842|Secondary|Changes of Phosphate Binder Doses||4 weeks, 8 weeks and 12 weeks|||||||
1367539|NCT01596842|Secondary|Changes of Erythropoietin Doses||4 weeks, 8 weeks and 12 weeks|||||||
1367540|NCT01596842|Secondary|Changes of Phosphorous Levels||4 weeks, 8 weeks and 12 weeks|||||||
1367541|NCT01596842|Secondary|Change of FGF-23 Levels||12 weeks|||||||
1367542|NCT01596842|Secondary|Change of Fetuin-A Levels||12 weeks|||||||
1367543|NCT01596842|Secondary|Change of Intact Parathyroid Hormone||12 weeks|||||||
1367544|NCT01596842|Secondary|Changes of Calcium Levels||4 weeks, 8 weeks and 12 weeks|||||||
1367545|NCT01596842|Secondary|Hemoglobin Levels at 12 Weeks||12 weeks||||g/dL||Standard Deviation|Mean
1367546|NCT01596842|Primary|25-hydroxyvitamin D Levels at 12 Weeks||12 weeks||||ng/ml||Standard Deviation|Mean
1367623|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367547|NCT01596582|Other Pre-specified|Concordance Between Patient Preferences for a Screening Tests Other Than Colonoscopy and Test Ordered for High Versus Low Risk Patients|Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
1367548|NCT01596582|Other Pre-specified|Concordance Between Patient Preference for Colonoscopy and Test Ordered for High Versus Low Risk Patients|Test-specific concordance between patient preference for colonoscopy and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
1367549|NCT01596582|Other Pre-specified|Concordance Between Patient Preferences for Screening Tests Other Than Colonoscopy and Test Ordered|Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for standard care versus risk assessment arms. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
1367550|NCT01596582|Other Pre-specified|Concordance Between Patient Preference for Colonoscopy and Test Ordered|Test-specific concordance between patient preference for colonoscopy and test ordered for standard care versus risk assessment groups. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
1367551|NCT01596582|Secondary|Provider Satisfaction|Provider satisfaction was assessed based on responses to a 3-item pretest administered prior to commencement of the study and the same 3-item posttest. The 3 items assessed to the extent to which providers felt that personalized risk assessment would be useful for: (1) selecting an appropriate screening test for their average risk patients [test selection]; (2) reduce time to decide on an appropriate screening modality [save time]; and (3) make them more receptive to patient preferences and possibly order a screening test other than colonoscopy [receptive to patient preferences]. Responses were assigned a point value ranging from 5= “strongly agree” and 1 = “strongly disagree”.|Two years|The difference in the number of providers reflect provider attrition during the 2-year study period.|||units on a scale||Standard Deviation|Mean
1367552|NCT01596582|Secondary|Screening Test Completion|Test completion rates were tracked using BMC’s electronic medical record, which captures results for all endoscopic procedures, imaging studies, and stool blood tests.|6 months||||Participants|||Count of Participants
1367553|NCT01596582|Secondary|Screening Intentions|Screening intentions were assessed on the posttest. Patients were asked how sure they were that they would complete the screening test that got scheduled Scores ranged from 5 = ‘‘completely’’ to 1 = ‘‘not at all sure.’’ Data was missing for 11 patients in the concordant group and 6 patients in the discordant group.|3 months||||units on a scale||Standard Deviation|Mean
1367554|NCT01596582|Secondary|Satisfaction With Decision-making Process (SDMP)|SDMP was assessed on the posttest using the validated 12-item Satisfaction with the Decision-Making Process scale. Individual items are assigned a point value ranging from 1 for ‘‘strongly disagree’’ (or ‘‘poor’’) to 5 for ‘‘strongly agree’’ (or ‘‘excellent’’). A cumulative score is then calculated based on the summed response scores for each item (maximum score = 60). Data was missing for 11 patients in the concordant group and 6 patients in the discordant group|One month|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category. The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.|||units on a scale||Standard Deviation|Mean
1367555|NCT01596582|Secondary|Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients|Concordance between patient preference and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%). Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).|||Participants|||Count of Participants
1367556|NCT01596582|Primary|Concordance Between Patient Preference and Test Ordered|Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
1367557|NCT01596504|Secondary|Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast|Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately.|0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed=participants with appetite perception assessment at specified time-points.|||mm||Standard Deviation|Mean
1367558|NCT01596504|Secondary|Change From Baseline to Day 57 in Waist Circumference||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57|PD population. Number of participants analyzed = participants with waist circumference assessment at specified time-points.|||cm||Standard Deviation|Mean
1367559|NCT01596504|Secondary|Change From Baseline to Day 57 in Body Weight||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57|PD population. Number of participants analyzed = participants with body weight assessment at specified time-points.|||kg||Standard Error|Least Squares Mean
1367621|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
1367560|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure|The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with blood pressure assessment at specified time-points.|||mmHg||Standard Deviation|Mean
1367561|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate|The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with heart rate assessment at specified time-points.|||beats per minute||Standard Error|Least Squares Mean
1367562|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Coefficient|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying.|0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed = participants with gastric emptying at specified time-points.|||coefficient (unit-less)||Standard Deviation|Mean
1367563|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry.|0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed=participants with gastric emptying assessment at specified time-points.|||minutes (min)||Standard Error|Least Squares Mean
1367564|NCT01596504|Secondary|Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose||Day -7 (Baseline), Day 56|PD population. Number of participants analyzed=participants with insulin glargine dose assessment at specified time-points.|||units||Standard Deviation|Mean
1367565|NCT01596504|Secondary|Change From Baseline to Day 56 in HbA1c|HbA1C was assessed using the high performance liquid chromatography method.|Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56|Number of participants analyzed = participants with HbA1c assessment at specified time-points.|||percentage of HbA1c||Standard Error|Least Squares Mean
1367566|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours|Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with glucagon assessment at specified time-points.|||h*ng/L||Standard Error|Least Squares Mean
1367567|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours|C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with C-peptide assessment at specified time-points.|||h*nmol/L||Standard Error|Least Squares Mean
1367568|NCT01596504|Secondary|Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)|Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated.|Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56|PD population. Number of participants analyzed = participants with 7 point SMPG assessment at specified time-points.|||mmol/L||Standard Deviation|Mean
1367569|NCT01596504|Secondary|Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline.|0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||mmol/L||Standard Error|Least Squares Mean
1367570|NCT01596504|Secondary|Change From Baseline to Day 56 in PPG Excursion|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||mmol/L||Standard Error|Least Squares Mean
1367622|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367572|NCT01596504|Secondary|Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||h*mmol/L||Standard Error|Least Squares Mean
1367573|NCT01596504|Primary|Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56|Pharmacodynamic (PD) population defined as all randomized participants, who received at least one dose of lixisenatide 20 μg, liraglutide 1.2 mg or liraglutide 1.8 mg, and had both a baseline assessment and at least one post-baseline assessment of any primary or secondary PD variables, irrespective of compliance with study protocol and procedures.|||h*mmol/L||Standard Error|Least Squares Mean
1367574|NCT01596283|Secondary|Postoperative Length of Stay|Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time|Postoperatively for the total admission time, up to 8 days||||days||Full Range|Median
1367575|NCT01596283|Secondary|Total Volume of Fluid Used Postoperatively|Postoperative fluid volume|Postoperatively for the total admission time, up to 8 days||||liter||Standard Deviation|Mean
1367576|NCT01596283|Secondary|Total Volume of Fluid Used Perioperatively|Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively|Up to the first 72 hours postoperatively||||liter||Standard Deviation|Mean
1367577|NCT01596283|Secondary|Low Cardiac Output Time|Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively|Up to the first 24 postoperative hours||||minutes||Standard Deviation|Mean
1367578|NCT01596283|Primary|Postoperative Complications|The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.|30 days post procedure||||Participants|||Count of Participants
1367579|NCT01596231|Primary|Drinking Behaviors|A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).|Study end||||beers consumed||Standard Deviation|Mean
1367580|NCT01596127|Secondary|Maximum Tolerated Dose (MTD) of Rituximab|MTD is dose level at which at least 1 of 3 participants experiences a dose-limiting toxicity (DLT). DLTdefined as clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meeting the NCI common terminology criteria that are CTCAE Grade 3 or 4.|2 weeks|Multiple dose levels were designed with a starting dose of 10 mg per injection followed by 25 mg once safety was established in the first 3 patients treated at the first dose level. The study moved tot he next dose level. Due to lack of response and slow accrual, participants were never treated on the next dose level and the study was terminated||||||
1367581|NCT01596127|Primary|Response Rate|The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.|2 weeks||||percentage of Participants|||Number
1367582|NCT01596088|Primary|Adverse Events|Number of participants experienced adverse events|4 weeks||||participants|||Number
1367583|NCT01596062|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24|(MDRDa formula) with imputation by last observation carried forward (LOCF)|Day 8, Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||mL/min/1.73m^2||Standard Deviation|Mean
1367584|NCT01596062|Secondary|Percentage of Participants With of Treatment Failures|Treatment failure was defined either as a BPAR, a graft loss, a death or a loss to follow-up. An extended treatment failure was also defined including treated borderline lesions, BPAR, graft loss, death or loss to follow-up. Treated borderline lesions were considered as acute rejection by investigators and DMC experts.|Day 84 (Week 12), Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||Percentage of participants|||Number
1367600|NCT01595646|Secondary|Functional Ability|Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale. The Dementia Severity Rating Scale is made up of sub-scales and the scores from each are summed to produce one score. The scale assess memory, ability to get from place to place, and speech and language each with a range from 0-6; recognition of family members and social and community both having a range from 0-5; orientation of time, orientation to place, ability to make decisions, home activities and responsibilities, and control of urination and bowels each having a range of 0-4; personal care- cleanliness and eating both with a range of 0-3. The total score range is from 0-54 and lower scores denotes better outcomes.|baseline, month 2, and month 4||||units on a scale||Standard Deviation|Mean
1367585|NCT01596062|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity|Antibody mediated acute rejection: C4d deposition, presence of circulating antidonor antibody, morphologic evidence of acute tissue injury such as acute tubular necrosis-like minimal inflammation or capillary and/or glomerular inflammation and/or thromboses or arterial inflammation. Cellular acute rejection: acute T-cell mediated rejection Type IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IIA: Mild to moderate intimal arteritis. Type IIB: Severe intimal arteritis comprising > 25% of the lumenal area. Type III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation).|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||Percentage of participants|||Number
1367586|NCT01596062|Secondary|Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)|BPAR is one of the components of treatment failure. One assessment of efficacy was BPAR. Renal graft biopsies were performed and the renal tissue was examined to determine if there was acute rejection of the renal transplant.|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||Percentage of participants|||Number
1367587|NCT01596062|Secondary|Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells|Cell counts of various subpopulations of T, B and NK lymphocytes (CD3, CD4, CD8, CD19 and CD56) (flow cytometry).|Day 0, Day 6, Day 42, Day 84 (Week 12)|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||10^9 cells/L||Standard Deviation|Mean
1367588|NCT01596062|Secondary|Percentage of T-cells That Bind Basiliximab to CD25 Receptors|This is the percentage of T cells binding basiliximab at all timepoints.|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||Percentage of T cells||Standard Deviation|Mean
1367589|NCT01596062|Secondary|AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84|Mean AUC was calculated only for patients who received two Simulect injections.|Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||Weeks * Percentage of T cells||Standard Deviation|Mean
1367590|NCT01596062|Primary|Saturation Rate of CD25 Antigen Saturation by Basiliximab|CD25 saturation is the percentage of T cells expressing CD25|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||percentage of T cells||Standard Deviation|Mean
1367591|NCT01596062|Primary|Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84|CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.|Day 84 (Week 12) after transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||Weeks * Percentage of saturated CD25||Standard Deviation|Mean
1367592|NCT01595854|Secondary|Number of Participants With Drug Related Adverse Events|The number of participants with drug related adverse events|From screening until the end-of-study examination|Treated set|||participants|||Number
1367593|NCT01595854|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1367594|NCT01595854|Primary|Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1367595|NCT01595646|Other Pre-specified|Glucose Tolerance|Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance|Change from Baseline in Glucose Tolerance at 16 Weeks|||||||
1367596|NCT01595646|Other Pre-specified|Cerebral Blood Flow|Functional MRI and arterial-spin labeling perfusion MRI|Change from Baseline in Cerebral Blood Flow at 16 Weeks|||||||
1367597|NCT01595646|Other Pre-specified|Plasma Biomarkers of AD|Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.|Change from Baseline in Plasma Biomarkers at 16 Weeks|||||||
1367598|NCT01595646|Other Pre-specified|Executive Function Composite|Sum of Z Scores from Dot Counting Test (test of executive functioning) and Benton Visual Retention Test Form F&G (a test of visual working memory)|Change from Baseline in Executive Functioning at 16 Weeks|||||||
1367599|NCT01595646|Secondary|The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision|This cognitive screening measure contains measures of confrontational naming, following commands, constructional praxis, ideational praxis, orientation, and language production and comprehension. Total scores range from 0–70, with higher scores indicating greater cognitive impairment.|Baseline, Month 2 and Month 4||||units on a scale||Standard Deviation|Mean
1367603|NCT01595646|Primary|Verbal Memory Composite|The composite will consist of the sum of Z scores for Delayed Story Recall and Buschke Selective Reminding Test. In the Story Recall test subjects listen to a story containing 44 informational bits that is read once. Subjects will be asked to recall the story immediately after the reading and after a 20-min delay. Credit is awarded for each bit recalled verbatim or accurately paraphrased. The Buschke Selective Reminding Test measures verbal memory through multiple trials of a list learning task. A list of 12 words is audibly presented to the subject, and subjects recall as many words as possible. On subsequent trials, subjects are only told those words they omitted on the previous trial. The procedure continues until the subject recalls all words on two successive trials or to the twelfth trial. After a 30-minute delay, subjects recall as many items as possible. Number of items recalled after the delay will be summed. Higher scores indicate better performance.|Change from Baseline in Verbal Memory at 16 weeks|The study is in data analysis and manuscript write-up.|||Change in Z score memory composite||Standard Error|Mean
1367604|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367605|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367606|NCT01595438|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
1367607|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367608|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
1367609|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
1367610|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367611|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367612|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367613|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367614|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367615|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367616|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
1367617|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367618|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
1367619|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
1367624|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367625|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
1367626|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
1367627|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
1367628|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
1367629|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
1367630|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
1367631|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367632|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367633|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
1367634|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)|||Participants|||Number
1367635|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
1367636|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
1367637|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367638|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
1367639|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
1372237|NCT01542502|Other Pre-specified|Heart Failure Symptoms (DASI)|Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.|28 days|||||||
1367640|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367641|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
1367642|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
1367643|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367644|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)|||Participants|||Number
1367645|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)|||Participants|||Number
1367646|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))|||Participants|||Number
1367647|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
1367648|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
1367649|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))|||Participants|||Number
1367650|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
1367651|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )|||Participants|||Number
1367682|NCT01594970|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects with data at this time point|||Percent Change||Standard Deviation|Mean
1372238|NCT01542502|Other Pre-specified|Correlation Between Endpoints|Correlation between interval change in peak VO2 and high sensitivity C-reactive protein|28 days|||||||
1367652|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
1367653|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367654|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367655|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient’s clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient’s clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367656|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
1367657|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
1367658|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participants|||Number
1367659|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
1367660|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participants|||Number
1367661|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
1367662|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367663|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367664|NCT01595438|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367665|NCT01595438|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367683|NCT01594970|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1380875|NCT01451398|Secondary|Mean 7-point Glucose Week 24 Values|Mean 7-point self-monitored blood glucose at Week 24|Week 24|Full analysis set for patients with data at Week 24|||mg/dL||Standard Deviation|Mean
1367666|NCT01595438|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
1367667|NCT01595386|Secondary|ACTH Stimulation Test|AdrenoCorticoTropic Hormone stimulation test will be performed at least 24 hours pre-bypass and immediately after successful discontinuation of bypass and compared. These outcomes will be used as a secondary outcome.|24 hours prebypass and 0 hours post-bypass||||microg/dL||Inter-Quartile Range|Median
1367668|NCT01595386|Secondary|Mortality|Subject mortality will in the CICU will be used as a secondary outcome.|Duration of CICU stay, approximately 1 week||||percentage of patients|||Number
1367669|NCT01595386|Secondary|CICU Length of Stay|CICU length of stay will be calculated from the time the subject is admitted to the CICU post-op until they are discharged from the unit. This will be used as a secondary outcome.|approximately 1 week||||hours||Inter-Quartile Range|Median
1367670|NCT01595386|Secondary|Time Until First Extubation|Respiratory values such as duration of intubation will be used as a secondary outcome.|Until discharge from hospital, approximately 2 weeks||||hours||Inter-Quartile Range|Median
1367671|NCT01595386|Secondary|Changes in Baseline Arterial-venous Oxygen Saturation Difference|Respiratory values such as changes in baseline arterial-venous oxygen saturation difference at admission to the pediatric cardiac intensive care unit will be used as a secondary outcome.|admit to the CICU||||percentage of arterial-venous saturation||Inter-Quartile Range|Median
1367672|NCT01595386|Secondary|Fluid Balance|Hemodynamic variable such as total fluid balance within the first 48 hours post-op will be used as a secondary outcome. Fluid balance is a calculation of the overall fluid status for a given time period. The total input (fluid, medications, etc) that are given to a patient during a given time frame (24 hours) minus the total output (urine, stool, drainage, etc. ) that comes out of a patient during a given time frame.|1st 48 hours post-op||||mL/kg||Inter-Quartile Range|Median
1367673|NCT01595386|Secondary|Average Inotrope Score|Average inotrope score over first 48 hours after Cardiac Intensive Care Unit admission was used as a secondary outcome. Inotrope Score is calculated based on the dose of inotropes currently infusing at a given time points. The formula for calculation is as follows: Epinephrine/Norepinephrine (mcg/kg/min) dose x100, plus Dopamine/Dobutamine (mcg/kg/min) dose x 1, plus Neosynephrine (mcg/kg/min) dose x10, plus Vasopressin (units/kg/hr) [(dose x60)/10,000] = Inotrope Score. Our institution does not include Milrinone in our inotrope score calculation because every patient receives a continuous infusion in the immediate post-operative period. The higher the inotrope score the more cardiac support the patient is requiring or the worse their cardiac function is becoming.|first 48 hours post-op||||Inotrope Score||Inter-Quartile Range|Median
1367674|NCT01595386|Secondary|Changes in Baseline Inflammatory Mediators|Changes in pre-op inflammatory mediators will be assessed at 0, 4, 12, 24 and 48 hours post bypass and used as a secondary outcome.|0, 4,12, 24, and 48 hours post bypass||||pg/mL||Inter-Quartile Range|Median
1367675|NCT01595386|Secondary|Hospital Length of Stay|The average length of hospital stay from the time the subject is admitted to the CICU post-op until they are discharged will be used as a secondary outcome.|Admit to CICU till hospital discharge, approximately 3 weeks||||days||Inter-Quartile Range|Median
1367676|NCT01595386|Secondary|Mean Number of Days Subjects Alive and Ventilator Free|Respiratory variables include such as alive, ventilator free days at 28 days post-op will be used as secondary outcome. The mean number of days subjects were live and ventilator free up to the 28 days after surgery.|up to 28 days post op||||days||Inter-Quartile Range|Median
1367677|NCT01595386|Primary|Incidence of Low Cardiac Output Syndrome (LCOS)|Low Cardiac Output Syndrome (LCOS) within the first 48 hours after post-operative admission to the Pediatric Cardiac Intensive Care Unit was used as the primary outcome. This was defined as a double in inotropic support from post-operative admit, requiring Extracorporeal Membrane Oxygenation (ECMO) support, receiving Cardiopulmonary Resuscitation, or death.|first 48 hours after cardiac intensive care unit (CICU) admission post-op||||percentage of patients|||Number
1367678|NCT01595282|Secondary|Pain Scores 15 Minutes Post-procedure|21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)|Fifteen minutes after the procedure||||units on a scale||Standard Deviation|Mean
1367679|NCT01595282|Secondary|Pain Scores Immediately After Cervical Dilation|21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)|Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula||||units on a scale||Standard Deviation|Mean
1367680|NCT01595282|Primary|Immediate Post-procedure Pain Score|The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).|Immediately (within 1 minute) after suction and speculum removal||||units on a scale||Standard Deviation|Mean
1367681|NCT01594970|Other Pre-specified|Change From Baseline in Hyperemia Severity in the Study Eye|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.|Baseline, Week 12|Intent to Treat: all treated subjects with data at this time point|||Participants|||Number
1380876|NCT01451398|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point self-monitored glucose at baseline|Baseline|Full analysis set|||mg/dL||Standard Deviation|Mean
1367684|NCT01594970|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.|Week 12|Intent to Treat: all treated subjects with data at this time point|||Participants|||Number
1367685|NCT01594853|Primary|Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training|Here, we will assess whether the degree of a person's white matter integrity (i.e. for tracts of interest as measured from MRI) predicts their ability to benefit from exercise. Our prediction is that those individuals with preserved white matter integrity will show the greatest improvement in hip flexor strength.|Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 18).|For the follow up visit, there are fewer participants in the analysis because 5 female carriers and 1 control were unable to return for the third follow up visit due to burden to travel costs.|||kg||Standard Deviation|Mean
1367686|NCT01594762|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE)|The number of participants with TEAEs, including Serious TEAEs, are reported|28 days|Safety|||Participants|||Count of Participants
1367687|NCT01594762|Secondary|Number of Participants With Microbiological Response|The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.|28 days|Intent-To-Treat Microbiological (positive for baseline pathogens)|||Participants|||Count of Participants
1367688|NCT01594762|Primary|Number of Participants With Clinical Response|The numbers of participants with Clinical Response, defined as resolution of infection, are reported.|28 days|Intent-To-Treat|||Participants|||Count of Participants
1367689|NCT01594749|Secondary|Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC|No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of participants|||Number
1367690|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 24 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of Participants|||Number
1367691|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of Participants|||Number
1367692|NCT01594749|Primary|Percentage of Participants With Severe Infusion-site Reactions|The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.|||Percentage of Participants|||Number
1367693|NCT01594749|Primary|Percentage of Participants With Infusion-site Thrombophlebitis|The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.|||Percentage of Participants|||Number
1367694|NCT01594749|Primary|Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)|A Complete Response was defined as no vomiting and no use of rescue medication.|25 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of Participants|||Number
1367695|NCT01594515|Secondary|AUC0-infinity of BI 1015550|Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1367696|NCT01594515|Secondary|Cmax of BI 1015550|Maximum measured concentration of the analyte in plasma.|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1367748|NCT01593670|Secondary|Number of Patients Who Became Transfusion Independent||4-6 Months Post Start of Cycle 1|7 of the 9 patients were not evaluable for this outcome measure - 5 went on to stem cell transplant and 2 died before reaching the 4-6 month post start of cycle 1 milestone.This left 2 evaluable patients for the outcome measure, and thus this endpoint is not informative due to lack of evaluable patients.|||Participants|||Count of Participants
1367697|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations|Percentage of subjects with clinically relevant abnormalities in physical examinations.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
1367698|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability|Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
1367699|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs|Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
1367700|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs|Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
1367701|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests|Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).|Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
1367702|NCT01594515|Primary|Number (%) of Subjects With Drug Related Adverse Events|Percentage of subjects with drug related adverse events.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
1367703|NCT01594424|Primary|Number of Participants With Serious Infectious Complications Following Transplantation|patients will be in the study for up to 2 years|24 months||||participants|||Number
1367704|NCT01594411|Primary|Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score|The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES <=15 in a population referred to myocardial perfusion imaging.|pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)|The study sites included 9 clinicians at 4 community-based primary care practices who assessed all participants with a valid ASGES.|||number of subjects|||Number
1367705|NCT01594385|Other Pre-specified|Would Complication|Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint|Up to 1 year follow-up period||||Wound complication|||Number
1367706|NCT01594385|Other Pre-specified|Patient Functional Outcomes|"Assessment of Glasgow Outcome Scale (GOS) and the Functional Outcome Measures (FOM) during the available follow-up period.~FOM Source: [1] Ohio Dept of Public Safety. Ohio Trauma Registry Data Dictionary. Columbus: 2004.~FOM Scale range: 1 (worst) to 4 (best); GOS Scale: 1 (worst) to 5 (best)~FOM Feeding Subscale~Fully dependent~Partially dependent~Independent w/device~Fully independent~FOM Locomotion Subscale~Fully dependent~Partially dependent~Independent w/device~Fully independent~FOM Expression/Communication Subscale~Fully dependent~Partially dependent~Independent w/device~Fully independent~Glasgow Outcome Scale:~Death~Persistent vegetative state: Minimal responsiveness~Severe disability: Conscious but disabled; dependent on others for daily support~Moderate disability: Disabled but independent; can work in sheltered setting~Good recovery: Resumption of normal life despite minor deficits"|Up to 1 year follow-up|Please see Outcome Measure Description [above] for exact measure(s) utilized, including measurement scale(s).|||units on a scale||Standard Deviation|Mean
1367707|NCT01594385|Other Pre-specified|Bowel Obstruction|Determination of bowel obstruction during the entire available study follow-up period|Up to 1 year follow-up||||Bowel obstruction|||Number
1367708|NCT01594385|Other Pre-specified|Infection / Abscess / Sepsis|Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods|Up to 1 year||||Total events|||Number
1367709|NCT01594385|Other Pre-specified|Ventral Hernia|Determination of ventral hernia presence during follow-up visits|Up to 1 year follow-up||||Hernia|||Number
1367710|NCT01594385|Other Pre-specified|Enterocutaneous and Other Fistula|Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval|Up to 1 year post-injury||||Total events|||Number
1367711|NCT01594385|Other Pre-specified|Patient Mortality|Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up)|28 days & end of follow-up|Note: Both mortalities in the Seprafilm group involved withdrawal of care as per previously stated patient wishes.|||Mortalities|||Number
1367712|NCT01594385|Secondary|Wound Healing Characteristics|There will not be a fixed duration of outpatient follow-up (fixed follow-up in trauma patients is not practical due to the unpredictable nature of trauma population), an average (mean) follow-up will be determined for the entire cohort of patients for the purposes of the study, up to a maximum of 1 year (if available) following hospital discharge.|Participants will be followed until their open abdomen is closed. Depending on the nature and severity of the wound, this period may last as long as 1 year after the patient has been discharged.|"Wound areas for Seprafilm and No Seprafilm groups were obtained serially, by measuring each wound horizontally and vertically and multiplying measurements (in centimeters) to determine the estimated area in cm squared."|||Square Centimeters (cm2)||Standard Deviation|Mean
1367713|NCT01594385|Primary|Adhesion Characteristics|"Zuhlke adhesion score (1 - minimum to 4 - maximum)~= filmy adhesions, easy to separate by blunt dissection~= stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization~= strong adhesions; lysis possible by sharp dissection only; clear vascularization~= very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable"|Up to 1 year||||Scores on a scale|Zuhlke Adhesion Score|Standard Error|Mean
1367714|NCT01594294|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.|Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||seconds|Participants|Standard Deviation|Mean
1367715|NCT01594294|Primary|Mean Upper Eyelid Margin Staining|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||square millimeters|Participants|Standard Deviation|Mean
1367716|NCT01594294|Primary|Mean Upper Eyelid Redness|The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||percentage of total surface measured|Participants|Standard Deviation|Mean
1367717|NCT01594294|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||units on a scale|Participants|Full Range|Median
1367718|NCT01594294|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||Units on a scale|Participants|Full Range|Median
1367719|NCT01594125|Secondary|Number of Participants With Response by Alpha Fetoprotein (AFP)|Response by AFP is defined as 20% or more decline in AFP between the baseline value and the AFP value after three courses (12 weeks) of therapy. If patients only receive two courses of therapy the AFP value after two courses (8 weeks) will be used for the analysis.|up to 28 months|Patients from TS and AFP evaluation (>20μg/L) at baseline and post-baseline AFP assessment after two or three courses.|||participants|||Number
1367720|NCT01594125|Secondary|Time to Progression (TTP)|TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0.|up to 28 months|Patients from TS|||months||Inter-Quartile Range|Median
1367721|NCT01594125|Secondary|Progression Free Survival (PFS)|PFS is defined as the duration from start date of the study treatment to PD according to RECIST 1.0, or any death whichever occurs earlier.|up to 28 months|Patients from TS|||months||Inter-Quartile Range|Median
1367722|NCT01594125|Secondary|Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Objective response (Complete response (CR) + Partial response (PR), regardless of confirmation) is derived from a patient’s best objective response by RECIST. Best objective response is calculated based on the “overall” visit response from each assessment. Best objective response represents the best response a patient has had during their time in the study up until progression, last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. For patients whose progression event is death, best objective response will be calculated based on data up until the last evaluable RECIST assessment prior to death.|up to 28 months|Treated Set (TS): The treated set includes all patients who were administered at least one dose of any study medication.|||participants|||Number
1367776|NCT01592799|Secondary|Number of Subjects With Secondary Bacterial Infections|The outcome assessed the various complications by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367723|NCT01594125|Primary|Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib|The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase [ALP] elevation >5x ULN, or total bilirubin >3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP > baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid.|up to 28 days|Patients from the MTD set: The MTD set contains only treated patients from the dose escalation that were not replaced for MTD determination.|||participants|||Number
1367724|NCT01593852|Primary|Cumulative Air Kerma (AK) Value|Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.|Day 0||||mGy||Inter-Quartile Range|Median
1367725|NCT01593852|Secondary|Serious Adverse Events||Day 0 if any||||participants|||Number
1367726|NCT01593852|Secondary|Usage of Physician Controlled Dose Settings|In both groups, default fluoroscopy dose settings were 'low', but could be changed by the operator to a medium or high setting for better imaging. The necessity to increase fluoroscopy dose for better imaging to medium or high was registered as a percentage of total number of fluoroscopy frames.|Day 0||||percentage of total # of fluoro frames||Standard Deviation|Mean
1367727|NCT01593852|Secondary|Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure|If fluoroscopy time (see results in other secondary outcomes), number of exposure frames (see below) and procedure duration (see results in other secondary outcomes) are equivalent between the two groups, this will indicate that image quality (IQ) is equally adequate in both groups.|Day 0||||Number of exposure frames||Standard Deviation|Mean
1367728|NCT01593852|Secondary|Fluoroscopy Time||Day 0||||minutes||Standard Deviation|Mean
1367729|NCT01593852|Secondary|Procedure Duration||Day 0||||minutes||Standard Deviation|Mean
1367730|NCT01593852|Secondary|Physician Professional Judgment on Procedural Success|Measurement of professional judgment (yes/no) of the treating physician.|Day 0||||percentage of procedural success|||Number
1367731|NCT01593852|Secondary|Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)|Staff dose measured by Electronic Personal Dosimeter (EPD) worn by the operator over the lead apron (EPD operator) and the other mounted at a fixed location in the EP laboratory (EPD fixed)|Day 0||||µSv||Inter-Quartile Range|Median
1367732|NCT01593852|Primary|Cumulative Dose Area Product (DAP) Value|Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.|Day 0||||Gy*cm^2||Inter-Quartile Range|Median
1367733|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8|Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.|8 weeks|FAS|||Percentage of participants|||Number
1367734|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8|Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline|8 weeks|FAS|||Percentage of participants|||Number
1367735|NCT01593787|Secondary|Percentage of Participants Achieving DBP Control at Week 8|DBP control was defined as msDBP <80 mmHg.|8 weeks|FAS|||Percentage of participants|||Number
1367736|NCT01593787|Secondary|Percentage of Participants Achieving SBP Control at Week 8|SBP control was defined as msSBP <130 mmHg.|8 weeks|FAS|||Percentage of participants|||Number
1367737|NCT01593787|Secondary|Percentage of Participants Achieving a Successful BP Control at Week 8|A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg|8 weeks|FAS|||Percentage of Participants|||Number
1367738|NCT01593787|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8||baseline, 8 weeks|FAS|||mmHg||Standard Deviation|Mean
1367739|NCT01593787|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements.|baseline, 8 weeks|Full Analysis Set (FAS): This set included all participants who entered the treatment epoch. Patients who were not qualified to enter the treatment epoch were excluded from the FAS provided those participants did not receive LCZ696.|||mmHg||Standard Deviation|Mean
1367740|NCT01593787|Primary|Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)|Percentage of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set: This set included all participants who received at least one dose of LCZ696. AE analysis was determined by actual treatment, i.e. the LCZ696 dose on the day in which the corresponding summary was targeting. Other safety analysis was determined by the maximum treatment.|||Percentage of participants|||Number
1367741|NCT01593722|Other Pre-specified|Treatment Efficacy|Proportion of subjects without signs of infection|6 months|Microfilarial count and symptoms|||participants|||Number
1367742|NCT01593722|Secondary|Proportion of Subjects Who Clear Microfilaremia||14 days||||participants|||Number
1367743|NCT01593722|Secondary|Eosinophil Activation|Levels of surface marker expression on eosinophils|3 days||||% cells expressing CD69||Full Range|Geometric Mean
1367744|NCT01593722|Secondary|The Frequency of Adverse Events|Symptoms, signs and laboratory abnormalities occurring in the 7 days post-treatment|7 days||||events|||Number
1367745|NCT01593722|Primary|The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment.||7 days||||percentage of baseline||Full Range|Geometric Mean
1367746|NCT01593670|Secondary|Overall Survival|Patients alive at 1 year.|1 Year||||Participants|||Count of Participants
1367747|NCT01593670|Secondary|Number of Patients Who Had Natural Killer (NK) Cell Expansion|NK cell expansion is defined as the presence of donor NK cells in the recipient at Day 8 post NK cell infusion.|After Cycle 2 (approx. 3 months)||||Participants|||Count of Participants
1380877|NCT01451398|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/100 Subject-Month|||Number
1367749|NCT01593670|Secondary|Number of Patients Who Experienced Grade 3 or Higher Non-hematologic Adverse Events|Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Non-hematologic adverse events are defined as untoward medical occurrences associated with the use of a study drug whether or not considered study drug related, excluding those events involving white blood cells, neutrophils, red blood cells or platelets. In general, grade 3 AEs are defined as 1) being severe or medically significant but,not immediately life-threatening; 2) requiring hospitalization or prolongation of hospitalization; 3) disabling; or 4) limiting self care activities. Grade 4 AEs are defined as 1) having life-threatening consequences; or 2) requiring urgent intervention. Grade 5 AEs are defined as causing death related to an adverse event.|Day 1 through Month 3||||Participants|||Count of Participants
1367750|NCT01593670|Primary|The Number of Patients Who Achieved a Clinical Response|Clinical response includes: Complete Response (less than 5% myeloblasts present in the bone marrow and in the peripheral blood a hemoglobin of at least 11g/dl, platelets of at least 100 X 10E9/L, neutrophils of at least 1.0 X 10E9/L, and blasts 0%); Partial Response (all Complete Response criteria if previously abnormal except bone marrow myeloblasts are decreased by more than 50% over pre-treatment, but still greater than 5%); and hematologic improvement (a hemoglobin increase of greater than 1.5g/dl or decreased red blood cell transfusions by at least 4 per 8 week period, a platelet increase of more than 30 X 10E9/L for patients with a baseline of more than 20 X 10E9/L or an increase by 100% for those with a baseline of less than 20 X 10E9/L, and a neutrophil increase of at least 100% and an absolute increase of greater than 0.5 X 10E9/L.|After 2 Courses of Treatment (Approx. 3 months)||||Participants|||Count of Participants
1367751|NCT01593592|Secondary|The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.|Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.|8 weeks||||participants|||Number
1367752|NCT01593592|Secondary|Severe Adverse Effects to the Used Medications and Dietary Supplements.||4 weeks||||percentage of participants|||Number
1367753|NCT01593592|Primary|Eradication of H Pylori Infection 4 Weeks After Completion of Therapy|H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.|4 weeks therapy|It is assessment of all the 70 participants about H pylori eradication status|||participants|||Number
1367754|NCT01593215|Secondary|Glucose|Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose|||||||
1367755|NCT01593215|Primary|Insulin Secretion|insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose||||% increase of Ins30||95% Confidence Interval|Mean
1367756|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||grams||Standard Deviation|Mean
1367757|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8|"Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated.~sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached."|Baseline to 8 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||grams||Standard Deviation|Mean
1367758|NCT01592864|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||Score on a scale||Standard Deviation|Mean
1367777|NCT01592799|Secondary|Number of Subjects With Fatal Outcomes|Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367759|NCT01592864|Primary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|Intent to Treat (ITT) Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||Score on a scale||Standard Deviation|Mean
1367760|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Force (grams)||Standard Deviation|Mean
1367761|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 3|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Force (grams)||Standard Deviation|Mean
1367762|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 14|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity"|Baseline to Day 14|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Force (grams)||Standard Deviation|Mean
1367763|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1367764|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1367778|NCT01592799|Secondary|Number of Subjects With Other Laboratory-confirmed Respiratory Viruses|Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367797|NCT01592708|Secondary|Post-discharge Nausea|To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital|1 week from discharge from hospital|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.|||percentage of subjects with PDN|||Number
1367765|NCT01592851|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 – participant responds to air stimulus and request discontinuation of stimulus, 3 – participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 14|Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
1367766|NCT01592799|Secondary|Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)|This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Percentage of household members||95% Confidence Interval|Number
1367767|NCT01592799|Secondary|Number of Subjects With Household Members With Influenza-like Illness|This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Household members|||Number
1367768|NCT01592799|Secondary|Number of Days of Parent or Caregiver Time Off Work|This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Days||Standard Deviation|Mean
1367769|NCT01592799|Secondary|Number of Days of School Absenteeism|School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Days||Standard Deviation|Mean
1367770|NCT01592799|Secondary|Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367771|NCT01592799|Secondary|Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367772|NCT01592799|Secondary|Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367773|NCT01592799|Secondary|Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367774|NCT01592799|Secondary|Number of Days of Hospitalization|The outcomes was assessed in subjects with laboratory-confirmed influenza status|Day 0 till Day 28-37 (between October 2010 until May 2011)|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Days||Standard Deviation|Mean
1367775|NCT01592799|Secondary|Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status|Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367779|NCT01592799|Primary|Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza|Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available and who were hospitalized or visited an emergency room.|||Euros||Standard Deviation|Mean
1367780|NCT01592799|Primary|Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever|ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
1367781|NCT01592786|Primary|Number of Confirmed Social Responsiveness Scale (SRS) Responders|"A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks.~The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment."|Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)|Of the 906 patients who enrolled in the study 903 received at least 1 dose of open-label treatment to comprise the Safety Population. The Intent to Treat (ITT) population included the 868 patients in the Safety population who also had at least 1 post–Visit 1 assessment of the SRS total raw score.|||participants|||Number
1367782|NCT01592773|Primary|Patients With Any Treatment-emergent Adverse Event|Number of patients who experienced 1 or more Treatment Emergent Adverse Event|Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit|Analysis was performed on the 747 patients who took at least 1 dose of investigational product (Safety Population).|||participants|||Number
1367783|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured at 24 hours after device placement/study initiation||||participants|||Number
1367784|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at Discharge|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured prior to discharge from phase II of the post-anesthesia care unit/recovery room||||participants|||Number
1367785|NCT01592760|Secondary|Overall Clinical Usefulness|Excellent, good, fair, or inadequate. Scale defined by clinical measures and observations.|Reported by the device operator at the time of device removal||||participants|||Number
1367786|NCT01592760|Secondary|Incidence of Oropharyngeal Injury|Oropharyngeal injury is defined as a new lip, tongue, buccal, or pharyngeal abrasion or laceration or dental damage observed in the immediate recovery area after use of a study device.|Measured in the post-anesthesia care unit/recovery room within 15 minutes after device removal||||participants|||Number
1367787|NCT01592760|Secondary|Incidence of Gastric Aspiration|Gastric aspiration is present when gross gastric contents or bile is observed on or within the device or within the subject's oropharynx. The outcome is the proportion of study subjects in whom the outcome measure was observed.|Measured between successful device placement and device removal for any reason.||||participants|||Number
1367788|NCT01592760|Secondary|Incidence of Gastric Insufflation|Gastric insufflation is present when audible air sounds are heard by stethoscope over the subject's epigastrium.|Measured within 5 minutes of device placement/study initiation||||participants|||Number
1367789|NCT01592760|Secondary|Device Use Time (Min)|Device Use Time is the time recorded to the nearest minute of the period bounded by the time the device placement was determined to be adequate in the study subject to its withdrawal from the study subject.|Measured between successful device placement and device removal for any reason, approximately 2 hours||||minutes||Standard Deviation|Mean
1367790|NCT01592760|Secondary|Device Position in Relation to the Vocal Cords|Device position in relation to the vocal cords is assessed with a flexible fiberoptic camera and graded as follows: 1 = full view of the vocal cords, 2 = partial view of the vocal cords including the arytenoids, 3 = view of the epiglottis only, and 4 = other (device cuff, pharynx or other structures).|Measured within 5 minutes of successful study device placement||||participants|||Number
1367791|NCT01592760|Secondary|Device Ease of Insertion|Device ease of insertion is graded as either easy, slightly difficult, difficult, or impossible. The outcome measure is the proportion of successful study device placements recorded as easy versus slightly difficult versus difficult versus impossible.|Reported by the device operator at the time successful device placement is recorded.||||participants|||Number
1367792|NCT01592760|Secondary|Device Placement Success Rate|Device placement success rate is defined as the proportion of devices successfully placed within three attempts at device placement.|Measured at the time of attempted study device placement immediately after the induction of general anesthesia||||participants|||Number
1367793|NCT01592760|Secondary|Device Placement Time|Device placement time is the time measured in seconds from when the study investigator picks up the airway device to confirmation of ventilation by the presence of an adequate end-tidal carbon dioxide tracing on the monitor.|Measured at device placement/study initiation||||seconds||Standard Deviation|Mean
1367794|NCT01592760|Primary|Airway Seal Pressure After Device Placement|Airway seal pressure is defined as the pressure in cmH2O at which the needle of a manometer attached to the anesthesia circuit reaches equilibration, associated with an audible air leak from the subject's oropharynx or gastric insufflation, limited to a maximum pressure of 40 cmH2O. It is measured with the subject's head and neck in neutral position, the expiratory valve on the anesthesia machine closed, and the fresh gas flow set to five liters per minute.|Measured within 5 minutes after device placement/study initiation||||cmH2O||Standard Deviation|Mean
1367798|NCT01592708|Secondary|Hospital Length of Stay|Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.|Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours||||hours||Inter-Quartile Range|Median
1367799|NCT01592708|Primary|Post-operative Nausea|End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.|End of surgery to discharge from hospital||||percentage of subjects with PON|||Number
1367800|NCT01592695|Secondary|Treatment Attendance|The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.|End of treatment (seven weeks after baseline)|Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition.|||Calls||Full Range|Mean
1367801|NCT01592695|Secondary|Retention|The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.|End of treatment (seven weeks after baseline)|Participants assigned to the tailored intervention condition who completed the intervention calls.|||Participants|||Count of Participants
1367802|NCT01592695|Secondary|Enrollment Rate|The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.|6 months after study initiation|Total number of participants randomized to each treatment condition.|||Participants|||Count of Participants
1367803|NCT01592695|Secondary|Body Weight|Self-reported body weight.|Six-month follow-up|Assessed among participants in the tailored intervention group who received the weight management module and those in the enhanced standard of care condition who would have been eligible for the weight management module if they had been assigned to the tailored intervention condition.|||Pounds||Standard Deviation|Mean
1367804|NCT01592695|Secondary|Depressive Symptoms|Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.|Six-month follow-up|Participants in the tailored intervention group who receive the mood management module and those in the enhanced standard of care condition who would have been eligible for the mood management module if they had been assigned to the tailored intervention condition.|||units on a scale||Standard Deviation|Mean
1367805|NCT01592695|Secondary|Alcohol Use|Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.|Six-month follow-up|Participants in the tailored intervention group who received the alcohol intervention and those in the enhanced standard of care group who would have been eligible for the alcohol intervention if they had been assigned to the tailored intervention group.|||Drinks consumed per day||Standard Deviation|Mean
1367806|NCT01592695|Secondary|Number of Participants Abstinent From Tobacco Use|At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).|Six-month follow-up|7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation).|||Participants|||Count of Participants
1367807|NCT01592695|Primary|Treatment Satisfaction|Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.|End of treatment (seven weeks after baseline)|Participants who completed treatment satisfaction items on three-month follow-up|||Participants|||Count of Participants
1367808|NCT01592435|Primary|Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)|1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.|5 weeks after completion of data collection||||units on a scale||Standard Error|Mean
1367809|NCT01592435|Primary|Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)|1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.|5 weeks after completion of data collection||||units on a scale||Standard Error|Mean
1367810|NCT01592396|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit|Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.|Day 1 and Day 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||participants|||Number
1367811|NCT01592396|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants.|Day 1 to Day 57|Safety population included all participants who received investigational product.|||participants|||Number
1367812|NCT01592396|Primary|Terminal Phase Elimination Half Life (t1/2)|Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||days||Standard Deviation|Mean
1368048|NCT01590563|Primary|Rates of Uterine Perforation|Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.|During installation||||Number of cases|||Number
1367813|NCT01592396|Primary|Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||mcg*day/mL||Standard Deviation|Mean
1367814|NCT01592396|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||(microgram*day)/milliliter (mcg*day/mL)||Standard Deviation|Mean
1367815|NCT01592396|Primary|Maximum Observed Serum Concentration (Cmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1367816|NCT01592396|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||days||Full Range|Median
1367817|NCT01592344|Secondary|Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey|Patient satisfaction with the StimRouter System was rated on a numerical rating scale (range 0 to 10), with 0 indicating not satisfied at all and 10 indicating completely satisfied.|at the 3-month follow-up|All subjects who completed the survey at Month 3 were included in this analysis. Four subjects in each study arm (4/45 Treatment; 4/49 Control) failed to complete the satisfaction survey.|||units on a scale||Standard Deviation|Mean
1367818|NCT01592344|Secondary|Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.|"Worst pain in the last 24 hours assessed using 7-day patient pain diary scores for BPI ranging from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Change from baseline to Month 3 was compared."|at baseline and 3 month follow-up|All available data were analyzed from both treatment arms.|||units on a scale||Standard Deviation|Mean
1367819|NCT01592344|Secondary|Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).|Patient Global Impression of Change in activity limitations, symptoms, emotions and overall life quality related to their painful condition (Range 1 to 7, with 1 indicating no change and 7 indicating a great deal better/considerable improvement).|at 3 month follow-up|All patients who completed the 3 month Global Impression of Change questionnaire were included. Four patients in each study arm failed to complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1367820|NCT01592344|Primary|Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%|The average pain at rest was assessed using a numerical (0-10) rating scale (NRS) on the Brief Pain Inventory (BPI) Short Form (SF). A higher score indicates worse pain (10=worst pain imaginable) and zero indicates 'no pain at all'. A pain reduction of greater than or equal to 30% on the NRS was considered to be clinically relevant.|Baseline and at 3-month follow-up.|Intent to treat (ITT) population was analyzed.|||participants|||Number
1367821|NCT01592292|Secondary|Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Baseline up to Month 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria.|||participants|||Number
1367822|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1367823|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1367853|NCT01592240|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
1367824|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||mg/dL||Standard Deviation|Mean
1367825|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1367826|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||mm/hr||Standard Deviation|Mean
1367827|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||millimeter/hour (mm/hr)||Standard Deviation|Mean
1367828|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||number of swollen joints||Standard Deviation|Mean
1367829|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||number of swollen joints||Standard Deviation|Mean
1367830|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||number of tender joints||Standard Deviation|Mean
1367831|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||number of tender joints||Standard Deviation|Mean
1367832|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in DAS28 at Month 12|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 12|Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point.|||units on a scale||Standard Deviation|Mean
1367833|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set.|||units on a scale||Standard Deviation|Mean
1367834|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria.|||units on a scale||Standard Deviation|Mean
1367835|NCT01592240|Secondary|Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)||Week 12, 24|"FAS included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percentage of participants|||Number
1367836|NCT01592240|Secondary|Plasma Concentration of PF-04950615 at Week 12 and 24||Week 12, 24|"Analysis set included all participants who received at least 1 dose of PF-04950615. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||Microgram per milliliter||Standard Deviation|Mean
1367837|NCT01592240|Secondary|Percentage of Participants With Injection Site Adverse Events|Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.|Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups|Safety analysis set included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1367838|NCT01592240|Secondary|Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)|Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.|Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups|Analysis set included all participants who received at least 1 dose of PF-04950615.|||percentage of participants|||Number
1367839|NCT01592240|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1367840|NCT01592240|Secondary|Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
1367841|NCT01592240|Secondary|Percent Change From Baseline in Triglycerides at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1367842|NCT01592240|Secondary|Change From Baseline in Triglycerides at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
1367843|NCT01592240|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1367844|NCT01592240|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
1367845|NCT01592240|Secondary|Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1367846|NCT01592240|Secondary|Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
1367847|NCT01592240|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
1367848|NCT01592240|Secondary|Change From Baseline in Total Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
1367849|NCT01592240|Secondary|Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
1367850|NCT01592240|Secondary|Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
1367851|NCT01592240|Secondary|Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
1367852|NCT01592240|Secondary|Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
1367854|NCT01592240|Secondary|Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
1367855|NCT01592240|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
1367856|NCT01592240|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
1367857|NCT01592240|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
1367858|NCT01592240|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline, Week 24|"Full analysis set included all participants who were randomized. Here Overall Number of Participants Analyzed, signifies number of participants those who were evaluable for this outcome measure."|||milligram per deciliter||95% Confidence Interval|Mean
1367859|NCT01592240|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"Full analysis set included all participants who were randomized. Here Overall Number of Participants Analyzed, signifies number of participants those who were evaluable for this outcome measure."|||milligram per deciliter (mg/dL)||95% Confidence Interval|Mean
1367860|NCT01592071|Primary|Waist-Hip Ratio (WHR)|Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).|30, 60 or 90 days from baseline||||ratio||Standard Deviation|Mean
1367861|NCT01592071|Primary|Hip Circumference|Measure of body composition: hip circumference (cm).|30, 60 or 90 days from baseline||||centimeters||Standard Deviation|Mean
1367862|NCT01592071|Secondary|Quality of Life|Quality of life categories measured with the SF-36 Health Survey. The SF-36 Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index.The SF-36 provides a t-score for each scale or domain ranging from 0-100 with higher scores representing better perceived quality of life.|30, 60 or 90 days from baseline||||Scores on a scale||Standard Deviation|Mean
1367863|NCT01592071|Secondary|Heart Rate|Heart rate measured.|30, 60 and 90 days from baseline||||bpm||Standard Deviation|Mean
1367864|NCT01592071|Primary|Waist Circumference|Measure of body composition: waist circumference (cm).|30, 60 and 90 days from baseline||||centimeters||Standard Deviation|Mean
1367865|NCT01592071|Primary|Body Mass Index|Measure of body composition: height and weight to assess BMI.|30, 60 and 90 days from baseline||||kg/m^2||Standard Deviation|Mean
1367866|NCT01592071|Secondary|Blood Pressure|Systolic and diastolic blood pressure measured.|30, 60 and 90 days from baseline||||mm Hg||Standard Deviation|Mean
1367867|NCT01592071|Primary|Weight (kg)|Measure of body composition: weight (kg).|30, 60 and 90 days from baseline||||kilograms||Standard Deviation|Mean
1367868|NCT01592045|Primary|Peak Plasma Concentration (Cmax)|"Twenty-two PK samples will be obtained at the following timepoints:~Courses 1 and 3:~Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample~Courses 2 and 4:~Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment||||ng/mL||Standard Deviation|Mean
1367869|NCT01592045|Primary|Area Under the Plasma Concentration Curve (AUC)|"Twenty-two PK samples will be obtained at the following timepoints:~Courses 1 and 3:~Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample~Courses 2 and 4:~Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment||||mcg*hr/mL||Standard Deviation|Mean
1367870|NCT01592006|Secondary|Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients|Tolerability and Safety will be measured and reported by serious adverse events.|6 years from the start of the study||||participants|||Number
1367871|NCT01592006|Primary|The Efficacy of Triple Antiviral Therapy|To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy [SVR24])|3 years from start of study||||percentage of participants|||Number
1367872|NCT01591954|Secondary|Data Recording for Retrospective Analysis|"The secondary outcome variable of this study is the data recorded by the video augmentation system during pertinent portions of the operation. We will be targeting steps in the procedure that would have the greatest benefit from an augmented video scene to be used later for further studies. Such data will form the subject of retrospective analysis of workflow.~Three sets of data will be collected to be able to reconstruct the video scene for analysis of the system:~- Tracked Endoscope information.~- Video from endoscopy~- Planning CT/MRI data"|Data is recorded during case.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.||||||
1367908|NCT01591616|Secondary|ECGs (QTcB Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
1367909|NCT01591616|Secondary|ECGs (QT Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
1367873|NCT01591954|Primary|Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist|"The qualitative assessment of new video augmentation software by the three surgeons surveys the effect of video augmentation overlay on overall surgical confidence, procedure, approach, and visualization.~= Significant hindrance / Negative effect;~= Minor hindrance / Slightly negative effect;~= Not helpful / No benefit or hindrance;~= Somewhat helpful / Slight benefit;~= Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time, personnel and possible contamination."|Assessment is immediate, following operation.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.||||||
1367874|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.|End of therapy fecal levels of OP-1118 (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data|||microgram/g||Standard Deviation|Mean
1367875|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.|3-5 hour plasma levels of OP-1118 (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data|||ng/mL||Standard Deviation|Mean
1367876|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.|Positive clinical response without recurrence through the follow-up period|28 days post-treatment|Treated subjects with positive toxin assay result within 24 hours of enrollment|||percentage of participants||95% Confidence Interval|Number
1367877|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Clinical Response.|Positive clinical response defined as resolution of diarrhea|Day 10|Treated subjects with positive toxin assay result within 24 hours of enrollment|||percentage of subjects||95% Confidence Interval|Number
1367878|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Fecal Samples.|End of therapy fecal levels of fidaxomicin (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data|||microgram/g||Standard Deviation|Mean
1367879|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Plasma Samples.|3-5 hour plasma levels of fidaxomicin (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data|||ng/mL||Standard Deviation|Mean
1367880|NCT01591863|Primary|Number of Participants With Adverse Events.|Number of participants with adverse events, as categorized by MedDRA.|Enrollment through end of study (Day 38-41)|Subjects receiving any amount of study drug|||participants|||Number
1367881|NCT01591837|Secondary|Frequency of Any Unsolicited AEs.|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
1367882|NCT01591837|Secondary|Frequency and Intensity of Any Solicited Adverse Events (AEs).|"The percentage of participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only.~Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site.~Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise.~Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented normal, everyday activities."|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
1367883|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
1367884|NCT01591837|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) was defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1367885|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) was defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) was defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
1367886|NCT01591733|Secondary|Utilization of Health Services (Emergency Room, Hospital and Intensive Care Unit)|Summary of the number of hospitalizations, intensive care unit (ICU) stays, emergency department (ED) stays, and palliative care use for the study population.|2 years||2019-01-31|01/2019||||
1367887|NCT01591733|Secondary|Quality of Life, Symptom Burden, and Mood|Patient-reported outcomes: We will use descriptive statistics to describe Quality of Life (QOL) (EORTC QLQ-C30), symptom burden (ESAS-r) and mood (HADS) for the entire study cohort.|2 years||2019-01-31|01/2019||||
1367888|NCT01591733|Secondary|Correlation of Mutational Analysis Biomarkers|To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment|2 years||2018-08-31|08/2018||||
1367889|NCT01591733|Secondary|Local Control Rates|The number of participants that achieved local control. Local control was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Local Failure is defined as progression of the primary tumor, or to the reappearance of tumor at the primary site.|From the start of treatment until the end of treatment with FOLFIRINOX, or until disease progression (median duration of follow-up of approximately 14 months)|The first 5 participants treated who only received 4 cycles of FOLFIRINOX instead of 8 were not included in the analysis of local control.|||Participants|||Count of Participants
1367890|NCT01591733|Secondary|Rate of Pathologic Downstaging|To determine the rate of pathologic down-staging among participants that underwent pancreaticoduodenectomy or distal pancreatectomy. The pathologic downstaging rate is the proportion of patients with the primary tumor and nodes downstaged based on final pathology of the surgical specimen.|Baseline, Post surgery||2018-08-31|08/2018||||
1367891|NCT01591733|Secondary|30 Day Post-operative Mortality Rate|The number of participants that died within 30 days after undergoing pancreaticoduodenectomy or distal pancreatectomy.|30 days post surgery (about 6 months from baseline)|The number of participants that underwent surgery|||Participants|||Count of Participants
1367892|NCT01591733|Secondary|The Proportion of Participants With Surgery Related Adverse Events|The number of participants with surgery related any grade adverse events following pancreaticoduodenectomy or distal pancreatectomy after receiving preoperative FOLFIRINOX and preoperative short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|At the time of surgery, 30 days post-surgery|The participants that underwent surgery|||proportion of participants||90% Confidence Interval|Number
1367893|NCT01591733|Secondary|Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation|Frequency of grade 3 or greater adverse events deemed related to FOLFIRINOX+short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From the start of treatment until the end of chemoradiation, about 4 months||||Participants|||Count of Participants
1367894|NCT01591733|Secondary|Median Overall Survival|Median overall survival, as measured from the start of treatment until the time of death.|From the start of treatment until the time of death, median duration of follow-up of 37.7 months||||Months||95% Confidence Interval|Median
1367895|NCT01591733|Secondary|Median Progression-Free Survival|The median progression free survival as measured from the start of treatment until the time of disease progression or death, whichever occurs first. Disease status was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Disease progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment until death or disease progression, median duration of follow-up of 14.7 months||||Months||95% Confidence Interval|Median
1367896|NCT01591733|Primary|Rate of R0 Resection|The rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas. R0 resection means that following surgery, no cancer cells are seen microscopically at the resection margin.|Post-surgery (about 4 months post baseline)||||Participants|||Count of Participants
1367897|NCT01591681|Secondary|Percent of Nights With Sensor Glucose >250 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
1367898|NCT01591681|Secondary|Overnight Area Under the Curve 250 mg/dl Per 8 Hour|The measure is reporting area under the curve for glucose concentrations below 250 mg/dL and above 60 mg/dL. Overall time below and above a threshold and area under a curve was divided by total time and multiplied by 8 hours.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||mg*hr/dL|Participants|Inter-Quartile Range|Median
1367899|NCT01591681|Secondary|Overall Mean Sensor Glucose Overnight|Calculated as the median of the overall mean.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||mg/dl|Participants|Inter-Quartile Range|Median
1367900|NCT01591681|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|42 mornings following night of system use||||percentage of mornings|Participants||Number
1367901|NCT01591681|Secondary|Percent of Mornings With Blood Ketones >1.0 mmol/L|Blood ketones measured with a study blood ketone meter.|42 mornings following night of system use||||percentage of mornings|Participants||Number
1367902|NCT01591681|Secondary|Percent of Mornings With Glucose >250 mg/dL|Measured with a study home blood glucose meter.|42 mornings following night of system use||||percentage of mornings|Participants||Number
1367903|NCT01591681|Secondary|Median Morning Blood Glucose|Measured with a study home blood glucose meter.|42 mornings following night of system use||||mg/dl|Participants|Inter-Quartile Range|Median
1367904|NCT01591681|Secondary|Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
1367905|NCT01591681|Secondary|Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
1367906|NCT01591681|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL|The median percentages of the number of glucose values with values of 71-180 mg/dL overall.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage glucose values|Participants|Inter-Quartile Range|Median
1367907|NCT01591681|Primary|Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl|Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
1367915|NCT01591616|Secondary|Vital Signs (Pulse)|Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.|Pre-dose and every 10 minute to 240 minutes post-dose.||||Beats per minute||Full Range|Mean
1367916|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes||||hours||Full Range|Geometric Mean
1367917|NCT01591616|Secondary|Safety|"The % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.~ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals.~Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose.~For each subject, phone call was made at +24h as follow up pursuant to the protocol."|blood draws pre-dose, 2 and 4 hours postdose||||Percentage MetHb||Standard Deviation|Mean
1367918|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1367919|NCT01591499|Secondary|Lens Preference - Ophthalmologist|"Ophthalmologists preference in terms of lenses rated by questionnaire with a limited selected response. (“Choice of Lens? First pair of lenses, Second pair of lenses”) (Biofinity, Air Optix, or Purevision)~Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 8 missing values; Evaluated at least one lens N=138, 16 missing values.)|||percentage of investigators|Participants||Number
1367920|NCT01591499|Secondary|Lens Preference - Participant|"The number of participants who preferred a lens pair rated by diary questionnaire with a limited selected response.(“Which pair of lenses did you prefer? The first pair, the second pair). Reported per lens.~Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 7 missing values; Evaluated at least one lens N=138, 15 missing values.)|||percentage of participants|||Number
1367921|NCT01591499|Secondary|Clinical Performance - Lens Wettability|"The ophthalmologist’s rating of lens wettability by questionnaire as a limited selected response (Zero, Low, Acceptable, Good or Excellent). Assessed with the slit lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||percentage of investigators|||Number
1367922|NCT01591499|Secondary|Geometric Performance - Lens Mobility|"The ophthalmologist’s rating of lens movement during blinking by questionnaire as a limited selected response (Optimal, Acceptable with a tendency to be tight, Acceptable with a tendency to be Flat, Unacceptable and too tight, or Unacceptable too flat). Assessed with the slit-lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||Investigators|||Number
1367923|NCT01591499|Secondary|Geometric Performance - Lens Centration|"Description: The ophthalmologist’s rating of lens centration during “Focus” and “Shift When Blinking” by questionnaire as a limited selected response (Optimal, Decentration Acceptable or Decentration Unacceptable). Assessed with the slit lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 12 missing values; Air Optix Aqua Multifocal N=70, 9 missing values; Purevision Multifocal N=68, 6 missing values)|||Investigators|||Number
1367924|NCT01591499|Secondary|Comfort of Use - Average Wearing Time|"The average numbers of hours per day of lens wear by patient. Reported per lens. Calculated by number of hours worn.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two Patients’ subjective rating for lens comfort of use by patient diary and reported per lens. (Average Wearing Time in hours per day)"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 11 missing values; Air Optix Aqua Multifocal N=70, 10 missing values; Purevision Multifocal N=68, 4 missing values)|||hours/day||Standard Deviation|Mean
1367925|NCT01591499|Secondary|Subjective Rating of Lens Comfort - General Comfort|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (General Comfort, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)|||units on a scale||Standard Deviation|Mean
1367926|NCT01591499|Secondary|Subjective Rating of Lens Comfort - End of Day|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (At End of Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||units on a scale||Standard Deviation|Mean
1367927|NCT01591499|Secondary|Subjective Rating of Lens Comfort - During Day|"Patients’ subjective rating for lens comfort by patient diary and reported per lens. (During the Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)|||units on a scale||Standard Deviation|Mean
1367928|NCT01591499|Secondary|Subjective Rating of Lens Comfort, Fitting|"Patients' subjective rating for lens comfort by patient diary and reported per lens. (After lens fitting, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||units on a scale||Standard Deviation|Mean
1367929|NCT01591499|Secondary|Visual Performance - Near Stereoscopic Vision|"The mean number of occurrences where the “number of the last figure where the patient equipped with analyzers can make out the raised circle (from number 1 to 9),” performed at a distance of 40 centimeters, using Wirt Vectographic Stereopsis Test. Reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 10 missing values; Air Optix Aqua Multifocal N=70, 7 missing values; Purevision Multifocal N=68, 4 missing values)|||number of occurrances||Standard Deviation|Mean
1367930|NCT01591499|Secondary|Visual Performance: Distance, High Contrast Vision|"The number of letters read at a distance of 5 meters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
1367931|NCT01591499|Secondary|Visual Performance: Distance, Low Contrast Vision|"The number of letters read at a distance of 5 meters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
1367932|NCT01591499|Secondary|Visual Performance: Near, High Contrast Vision|"The number of letters read at a near of 40 centimeters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
1367933|NCT01591499|Secondary|Visual Performance - Near, Low Contrast Vision|"The number of letters read at a near of 40 centimeters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
1367934|NCT01591499|Secondary|Visual Performance - Quality of Distance Vision|"Patients' subjective rating for quality of distance vision by patient diary and reported per lens. (driving, looking at a landscape, etc. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)|||units on a scale||Standard Deviation|Mean
1367935|NCT01591499|Secondary|Visual Performance - Quality of Intermediate Vision|"Patients' subjective rating for quality of intermediate vision by patient diary and reported per lens. (distance equivalent to an arm's length. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 3 missing values)|||units on a scale||Standard Deviation|Mean
1367936|NCT01591499|Secondary|Visual Performance - Quality of Near Vision|"Patients' subjective rating for quality of near vision by patient diary and reported per lens. (40cm away: reading a newspaper, looking at your watch etc. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)|||units on a scale||Standard Deviation|Mean
1367937|NCT01591499|Secondary|Visual Performance - Distance Visual Acuity|"Description: The participant’s distance binocular visual acuity (at 5 meters) using the La Galinet method. (Decimal scale, Excellent=between 5 and 20 tenths at 5 metres and between 1 and 20 tenths at 40 cm)~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measure at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 6 missing values; Purevision Multifocal N=68, 6 missing values)|||decimal units on a scale||Standard Deviation|Mean
1372239|NCT01542502|Secondary|Exercise Time|Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment|14 days||||minutes||Inter-Quartile Range|Median
1367938|NCT01591499|Primary|Visual Performance - Comparison of Initial Refraction to Multifocal Lenses|"The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5).~Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation):~V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Change over time measured at V1, V3 and V5|"Percentage of patients who obtained distance and near binocular visual acuities at least as good as their initial refraction visual acuities.~(Participant Flow: Biofinity Multifocal N=138, 14 missing values; Air Optix Aqua Multifocal N=70, 12 missing values; Purevision Multifocal N=68, 13 missing values)"|||percentage of participants|||Number
1367939|NCT01591499|Secondary|Visual Performance - Near Visual Acuity|"Description: The participant’s near binocular visual acuity (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5) and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 8 missing values; Purevision Multifocal N=68, 8 missing values)|||participants|||Number
1367940|NCT01591460|Secondary|Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up|Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.|||percentage of participants|||Number
1367941|NCT01591460|Secondary|Percentage of Participants With a Concomitant Disease Prior to or During the Study|The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here.|Up to 76 weeks (from Screening until 24 weeks after EOT)|Safety Population.|||percentage of participants|||Number
1367942|NCT01591460|Secondary|Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up|Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.|||percentage of participants|||Number
1367943|NCT01591460|Secondary|Time to Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population.|||weeks||95% Confidence Interval|Median
1367944|NCT01591460|Secondary|Number of Participants With a Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population.|||participants|||Number
1367945|NCT01591460|Secondary|Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir|The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; only participants providing evaluable data were included in the analysis. Arms were not mutually exclusive.|||percentage of participants|||Number
1367946|NCT01591460|Secondary|Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; n = number of participants who received the respective study medication. Arms were not mutually exclusive.|||percentage of participants|||Number
1367947|NCT01591460|Secondary|Duration of Treatment With PEG-IFN, RBV, and Boceprevir|The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment; n = number of participants who received the respective study medication. Arms were not mutually exclusive.|||weeks||Full Range|Median
1373430|NCT01527162|Primary|Walking Activity Levels|Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.|average of 5 days of second week of intervention||||average total strides/day||Standard Deviation|Mean
1367948|NCT01591460|Secondary|Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA|Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100.|At 12 and 24 weeks|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants|||Number
1367949|NCT01591460|Secondary|Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA|Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment decline in HCV RNA were included in the analysis. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1367950|NCT01591460|Secondary|Percentage of Participants With Virological Breakthrough Following On-Treatment Response|Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment virological response were included in the analysis. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1367951|NCT01591460|Secondary|Percentage of Participants With Virological Relapse Following EOT Response|Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (at 12 and 24 weeks after EOT)|All-Treated Population; only participants with a previous EOT virological response were included in the analysis. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1367952|NCT01591460|Secondary|Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA|HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, and 28|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1367953|NCT01591460|Secondary|Percentage of Participants With Virological Response|HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1367954|NCT01591460|Secondary|HCV RNA Levels|HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL.|At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)|All-Treated Population; number (n) = number of participants who provided evaluable data at the respective visit. Arms were not mutually exclusive.|||log10 IU/mL||Standard Deviation|Mean
1367955|NCT01591460|Secondary|Percentage of Participants With SVR at 24 Weeks After EOT|SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 24 weeks after EOT (up to 72 weeks)|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1367956|NCT01591460|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)|SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 12 weeks after EOT (up to 60 weeks)|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
1367957|NCT01591408|Primary|Improved Symptom Ratings|"Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning not at all and 10 being extremely anxious/irritable."|4 weeks|Subjects were active duty military with PTSD diagnosis currently in residential treatment facility|||Rating on scale||Standard Deviation|Mean
1367975|NCT01591018|Secondary|Number of Participants With Clinical Manifested Brain Infarction|to demonstrate an effect of sonolysis on the reduction of risk of clinically stroke due to the activation of endogenous fibrinolytic system during cardiac surgery|30 days after intervention|All enrolled participants were analyzed|||participants|||Number
1367958|NCT01591382|Secondary|Number of Participants With Treatment Related Adverse Events (AEs)|Participants were asked to complete a “Side Effects Checklist” to assess for any unwanted side effects (AEs) of drugs that were administered. The determination of whether or not an AE was treatment related was at the discretion of the Investigator.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study and also completed the Side Effects Checklist.|||participants|||Number
1367959|NCT01591382|Secondary|24-Hour Postoperative Opioid Use|Opioid use is defined as the total milligrams of hydromorphone plus other home or oral opioid used per 24 hours, converted to oral morphine equivalents.|For 24 hours following surgery|All randomized participants who completed the study.|||oral morphine mg equivalents||Standard Deviation|Mean
1367960|NCT01591382|Secondary|Least Postoperative Pain Score|Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for “worst,” “average,” and “least” pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average least postoperative pain score for each treatment arm is reported.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.|||units on a scale||Standard Deviation|Mean
1367961|NCT01591382|Secondary|Worst Postoperative Pain Score|Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for “worst,” “average,” and “least” pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average worst postoperative pain score for each treatment arm is reported.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.|||units on a scale||Standard Deviation|Mean
1367962|NCT01591382|Primary|Average Postoperative Pain Score|Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for “worst,” “average,” and “least” pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.|||units on a scale||Standard Deviation|Mean
1367963|NCT01591317|Secondary|Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges|Predose up to 24 hours post dose on Day 12|All randomized participants|||Percent inhibition of PRU||Standard Deviation|Mean
1367964|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants|||hours||Full Range|Median
1367965|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1367966|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 11 predose to 24 hours post dose|All randomized participants|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1367967|NCT01591317|Secondary|Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation|ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition|Predose up to 24 hours post dose on Day 12|All randomized participants|||PRU||Standard Deviation|Mean
1367968|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants|||hours||Full Range|Median
1367969|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1367970|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 1 predose up to 24 hours post dose|All randomized participants|||nanogram times hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1367971|NCT01591096|Secondary|Pharmacokinetics of tPA|TIPS will determine the pharmacokinetics of tPA and its inhibitor, plasminogen activator inhibitor, including free tPA, PAI-1, and tPA antigen in children receiving IV tPA for acute AIS. In addition, TIPS will measure the 3-month neurological outcome in children treated with IV tPA.|24 hours|Data cannot be reported in the data table as no data was collected||||||
1367972|NCT01591096|Secondary|Pharmacokinetics of tPA|TIPS will determine the pharmacokinetics of tPA and its inhibitor, plasminogen activator inhibitor, including free tPA, PAI-1, and tPA antigen in children receiving IV tPA for acute AIS. In addition, TIPS will measure the 3-month neurological outcome in children treated with IV tPA.|24 hours|Data cannot be reported in the data table as no data was collected||||||
1367973|NCT01591096|Primary|Symptomatic Intracranial Hemorrhage|Any PH 2 OR, Any intracranial hemorrhage which is judged to be the most important cause of neurological deterioration (a minimum of change of 2 or more points on the PedNIHSS from the lowest PedNIHSS). At the time of each PedNIHSS assessment, the site PI or co-PI will review the patient's course with the care team to ensure that all changes in neurologic status, including improvements since the last assessment by the study team, are captured, OR, Any hemorrhage that results in the need for transfusion, need to discontinue study drug, surgical evacuation of hemorrhage, or death.|36 hours|Data cannot be reported in the data table as no data was collected||||||
1367974|NCT01591044|Primary|Change in FEV1|Change from baseline in pre-BD FEV1 (% predicted) at Week 8.|Baseline and Week 8|All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients.|||percentage of change||Standard Deviation|Mean
1367976|NCT01591018|Secondary|Cognitive Decline|"To demonstrate an effect of sonolysis on the reduction of cognitive decline after cardiac surgery measured by ACE-R.~Adenbook´s cognitive examination - revised (ACE-R) can aquire value 0 to 100. Higher value represents better cognitive functions."|30 days after intervention|"50 out of 60 participants completed all cognitive tests in cardiac surgery with sonolysis group.~50 out of 60 participants completed all cognitive tests in cardiac surgery without sonolysis group."|||units on a scale||Inter-Quartile Range|Median
1367977|NCT01591018|Primary|Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI|to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions and brain infarctions > 0.5 cm3 in the monitored MCA territory in sonolysis group detected using MRI examination 24 hours after cardiac surgery in 5% level of statistical significance|24 hours after intervention||||participants|||Number
1367978|NCT01591005|Other Pre-specified|Number of Participants With Complications|Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.|24 hours and 30 days after intervention||||participants|||Number
1367979|NCT01591005|Secondary|Number of Participants With Clinical Vascular Event or Death|"The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) after carotid endarterectomy and carotid stenting using periprocedural sonolysis.~Substudy: The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) between carotid endarterectomy and carotid stenting groups."|30 days after intervention||||participants|||Number
1367980|NCT01591005|Secondary|Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups|"The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.~Substudy: The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention||||participants|||Number
1367981|NCT01591005|Secondary|Number of Participants With Clinical Manifested Brain Infarction|"The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system during carotid endarterectomy and carotid stenting using periprocedural sonolysis.~Substudy: The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system between carotid endarterectomy and carotid stenting groups."|24 hours and 30 days after intervention||||participants|||Number
1367982|NCT01591005|Secondary|Cognitive Decline|"The changes in cognitive functions after carotid endarterectomy and carotid stenting measured by Mini-Mental State Examination using periprocedural sonolysis.~Substudy: The changes in cognitive functions after intervention measured by Mini-Mental State Examination between carotid endarterectomy and carotid stenting groups.~Range of scores possible for the Mini-Mental State Examination: 0 - 30 points. Higher values in this range are considered to be a better outcome."|24 hours after intervention|only patients with performed Mini Mental State examination|||Scores on a scale||Inter-Quartile Range|Median
1367983|NCT01591005|Secondary|Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups|"The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.~Substudy: The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention||||participants|||Number
1367984|NCT01591005|Primary|Participants With a New Brain Infarction Detected Using Magnetic Resonance|"The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting.~Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups."|24 hours after intervention||||participants|||Number
1367985|NCT01590979|Primary|Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients||3 weeks after surgery|Fifty-four patients were randomized with a mean follow-up of 25 months and none were lost to follow-up. The study was terminated due to slow rate of accrual resulting in a sample size of 27 ranolazine and 27 placebo.|||Participants|||Count of Participants
1367986|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - TMT Part B|"Trail Making Test Part B was assessed by the number of seconds to complete the test (from 0 to 240 seconds).~The Trails Making Test Part B actual change from baseline at Week 26 was analysed."|Baseline to 26 weeks|Intent to Treat|||seconds||Standard Deviation|Mean
1367987|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of the structural brain volume as assessed by the left caudate volume.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.|||mm^3||Standard Deviation|Mean
1367988|NCT01590888|Secondary|Change From Baseline in Urine Biomarkers|Biomarkers assessed primarily with 8-hydroxy-2'-deoxyguanosine, normalised to creatinine concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population|||ng/mL||Standard Deviation|Mean
1367989|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers - Selenium|Biomarkers assessed primarily with plasma selenium as a change from baseline.|Baseline to 26 weeks|ITT population|||ug/L||Standard Deviation|Mean
1367990|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with soluble huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population|||mg/mL||Standard Deviation|Mean
1367991|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of whole brain iron concentrations.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.|||mm^3||Standard Deviation|Mean
1367993|NCT01590888|Secondary|Change From Baseline in Investigator Global Assessments by Efficacy Index|Global function was assessed by the Investigator using the clinical global impression (CGI) scale which included assessing the severity of illness and global improvement and calculating the efficacy index for each participant. The efficacy index aims to relate therapeutic effects to reported side effects as assessed by the Investigator (range from 0 [marked improvement and no side effects] to 4 [unchanged or worse] and side effects outweigh therapeutic effects) and is calculated for each participant by dividing the therapeutic effect score by the side effects score. An improvement is reflected by CGI scale Efficacy Index values >1.|Baseline to 26 weeks|Intent to Treat|||ratio||Standard Deviation|Mean
1367994|NCT01590888|Secondary|Change From Baseline in Behaviour|Total Behavioural score from the Unified Huntington Disease Rating Scale. The behavioural assessment measures the frequency and severity of symptoms related to affect, thought content and coping styles. The total behaviour score is the sum of all responses, with scale range of 0 to 8. Higher scores on the behaviour assessments indicate more severe disturbance than lower scores.|Baseline to 26 weeks|Intent to Treat population analysed|||units on a scale||Standard Deviation|Mean
1367995|NCT01590888|Secondary|Change From Baseline in Functional Abilities|"Total Functional Capacity (TFC) assessment was based on an individual's ability to perform common daily tasks. TFC score range was 0 to 13.~Higher scores on the function scales indicate better functioning than lower scores."|Baseline to 26 weeks|Intent to Treat Population analysed|||units on a scale||Standard Deviation|Mean
1367996|NCT01590888|Secondary|Change From Baseline in Motor Function|Total motor score calculated from the Unified Huntington Disease Rating Scale - Motor Function. The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor impairment scores is the sum of all the individual motor ratings, with higher scores indicating more severe motor impairment than lower scores. A maximum score of 60 is possible (range 0-60).|Baseline to 26 weeks|Intent to Treat population analysed, and defined as all participants who received at least one dose of study and underwent at least one post baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1367997|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - Composite z Scores|Cognition composite z-scores were calculated for each participant. The composite scores were defined as the mean of the individual z-scores for the various cognition assessments. The Main Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test and Stroop Word Reading Test. The Exploratory Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, Stroop Word Reading Test and Speeded Tapping test. The Executive Function Composite z-score was calculated from Category Fluency Test and Trail Making Test Part B. There is no unit of measure for the z score as it is the pure number calculated from the SD from the mean. A higher z score indicates an improvement.|Baseline to 26 weeks|Intent to Treat|||z score||Standard Deviation|Mean
1367998|NCT01590888|Primary|Safety and Tolerability of PBT2 in Patients With HD|As measured by the total number of participants in each dose group who reported at least one adverse events during the study,|Baseline to 26 weeks|Safety population as defined as all participants who received at least one dose of study drug.|||participants|||Number
1367999|NCT01590875|Primary|Pulmonary Vein Reconnection|In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection. Criteria for pulmonary vein reconnection will be recurrence of local pulmonary vein electrical recordings noted on lasso catheter located within the vein. Pulmonary vein isolation is defined as disappearance of all local intracardiac electrograms within a pulmonary vein recorded on a 10 electrode circular catheter or lasso catheter positioned within the vein.|Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.||||Participants|||Count of Participants
1368000|NCT01590875|Primary|Pulmonary Vein Reconnection|In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes after adenosine administration.|5 minutes post infusion first dose adenosine||||Participants|||Count of Participants
1368001|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
1368002|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
1368111|NCT01589497|Secondary|Ethambutol PK Parameter CL/F|Ethambutol PK parameter CL/F obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||L/hour||Inter-Quartile Range|Median
1368003|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368004|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368005|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
1368006|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
1368007|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368008|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368027|NCT01590797|Primary|Number of Participants Discontinuing Study Medication Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 24|The APaT population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.|||Participants|||Number
1368009|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
1368010|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
1368011|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368012|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368013|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||beats per minute||Standard Error|Least Squares Mean
1368014|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population|||beats per minute||Standard Error|Least Squares Mean
1368028|NCT01590797|Primary|Number of Participants With One or More Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 26|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.|||Participants|||Number
1380878|NCT01451398|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/Subject-Month|||Number
1368015|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||beats per minute||Standard Error|Least Squares Mean
1368016|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 12 Hours (TWA0-12hrs) HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||beats per minute||Standard Error|Least Squares Mean
1368017|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1368018|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1368019|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1368029|NCT01590797|Secondary|Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1368030|NCT01590797|Secondary|Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.|||A1C %||95% Confidence Interval|Least Squares Mean
1368020|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose; except Period 1: Pre-dose and 2, 4, 12 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||percentage of central pulse pressure||Standard Error|Least Squares Mean
1368021|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
1368022|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
1368023|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368024|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
1368025|NCT01590810|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug|||participants|||Number
1368026|NCT01590810|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug|||participants|||Number
1368031|NCT01590797|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.|||A1C %||95% Confidence Interval|Least Squares Mean
1368032|NCT01590771|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 24 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.|||Participants|||Number
1368033|NCT01590771|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 26 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.|||Participants|||Number
1368034|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1368035|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1368036|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1368037|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1368038|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
1368039|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
1368040|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1368041|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1368042|NCT01590771|Primary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
1368043|NCT01590758|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|The numbers of participants with TEAEs, including those with Serious TEAEs, are reported|28 days|Safety|||Participants|||Count of Participants
1368044|NCT01590758|Secondary|Number of Participants With Microbiological Success|The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.|28 days|Intent-To-Treat Microbiological (positive for baseline pathogens)|||Participants|||Count of Participants
1368045|NCT01590758|Primary|Number of Participants With Clinical Response|The numbers of participants with Clinical Response, defined as resolution of infection, are reported.|28 days|Intent-To-Treat|||Participants|||Count of Participants
1368049|NCT01590550|Secondary|Heparin Use Rate|The heparin use rate will be assessed as the percentage of hemodialysis treatments that required additional use of heparin to maintain circuit patency. This will be assessed from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued||||percentage of hemodialysis treatments|||Number
1368050|NCT01590550|Secondary|Saline Flush Rate|Saline flush rate will be assesed as the percentage of hemodialysis treatments that require one or more saline flushes to maintain circuit patency from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks||||percentage of hemodialysis treatments|||Number
1368051|NCT01590550|Primary|Dialyzer Clotting Rate|Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.|Followed until HD with Citrate dialysate is discontinued, average 3 weeks|18 patients and 119 HD treatments|||percentage of total treatments|||Number
1368052|NCT01590394|Primary|Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.||6 months|Data were not analyzed, because there were too few subjects to make the outcome measure meaningful. Principal investigator retired before any analysis could be performed.||||||
1368053|NCT01590264|Secondary|Change in Tinnitus Handicap Inventory|Participant will complete the Tinnitus Handicap Inventory (THI)at the end of 2 weeks of treatment. Difference of the THI post treatmement minus baseline THI was calculated. Scale ranges in scores from 0 to 100 with 0 = no bother and 100 being the most bothered.|Baseline, 2 weeks|Pilot study convenience sample|||units on a scale||Full Range|Median
1368054|NCT01590264|Primary|Adverse Events|Subject will be queried for Adverse Events daily for 2 weeks of treatment. This is foremost a feasibility study, so measure of Adverse Events and relation to treatment is primary outcome.|Daily for 2 weeks.|Pilot study based on convenience sample.|||participants|||Number
1368055|NCT01590238|Primary|Hair Density Change After Three Treatments|Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.|6 months after initial visit||||percentage of pre-treatment hair density||Standard Deviation|Mean
1368056|NCT01590212|Primary|Depression Measured on EPDS|"Depression scores as measured on the EPDS post-birth (approximately 8-12 weeks postnatal)~Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-birth (8-12 weeks postnatal)||||scores on a scale||Full Range|Mean
1368057|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on the Adult Wellbeing Scale post-birth (approximately 8-12 weeks postnatal)~The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post-birth (8-12 weeks postnatal)||||scores on a scale||Full Range|Mean
1368058|NCT01590212|Primary|Depression Measured on EPDS|"Depression as measured on the EPDS at 9-12 weeks after baseline~Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-intervention (approximately 9 -12 weeks after baseline)||||scores on a scale||Full Range|Mean
1368059|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on Adult Wellbeing Scale at 9-12 weeks after baseline.~The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post intervention (approximately 9-12 weeks after baseline)||||Scores on a scale||Full Range|Mean
1368060|NCT01589978|Secondary|ARC ST Rate in PLATINUM-like Population.|Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).|Annually through 5 years|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.|||percentage of participants|||Number
1368061|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients|Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)|12 Months||||percentage of patients|||Number
1368062|NCT01589978|Secondary|All Death or Myocardial Infarction Rate|See description of individual events.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368108|NCT01589497|Secondary|AUC0-24hour for Moxifloxacin (Mox) at Day 14|PK AUCs of Moxiflozacin (Mox) from 0 to 24 hours obtained at Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14|||h*ng/mL||Inter-Quartile Range|Median
1368063|NCT01589978|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as death not due to cardiac causes.~Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded."|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368064|NCT01589978|Secondary|All Death Rate|All death includes cardiac death and non-cardiac death.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368065|NCT01589978|Secondary|Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368066|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368067|NCT01589978|Secondary|Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368068|NCT01589978|Secondary|Cardiac Death or Myocardial Infarction (MI) Rate|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368069|NCT01589978|Secondary|Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368070|NCT01589978|Secondary|Target Vessel Revascularization (TVR) Rate|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368071|NCT01589978|Secondary|Rate of Cardiac Death Events Related to the PROMUS Element Stent|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368072|NCT01589978|Secondary|Cardiac Death Rate|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368073|NCT01589978|Secondary|Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368074|NCT01589978|Secondary|Myocardial Infarction (MI) Rate|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368075|NCT01589978|Secondary|Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent|Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368076|NCT01589978|Secondary|Major Adverse Cardiac Event Rate (MACE)|Composite of cardiac death, myocardial infarction, and target vessel revascularization|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368077|NCT01589978|Secondary|Rate of Longitudinal Stent Deformation|Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.|Index Procedure||||stents|||Number
1368109|NCT01589497|Secondary|Ethambutol PK Parameter CLast|Ethambutol PK parameter CLast obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
1368078|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
1368079|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients|ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)|12 months|PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776.|||percentage of patients|||Number
1368080|NCT01589978|Primary|Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients|Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)|12 months|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.|||percentage of patients|||Number
1368081|NCT01589822|Secondary|Incidence of Stricture||up to Day 90||||participants|||Number
1368082|NCT01589822|Secondary|Incidence of GI Leak||90 days|The primary endpoint was absence of leak (success) within 40 days. Any data missing was considered failures. 3 EVICEL and 2 SoC subjects had missing data. These subjects were considered failures for the primary endpoint. The secondary endpoint was incidence of leak within 90 days post operatively. Missing data was not assumed to be leaks.|||participants|||Number
1368083|NCT01589822|Secondary|Incidence of Adverse Events||up to Day 90||||number of adverse events|||Number
1368084|NCT01589822|Primary|Absence of Gastrointestinal (GI) Leak||40 days||||participants|||Number
1368085|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.|||scores on a scale||Standard Deviation|Mean
1368086|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.|||scores on a scale||Standard Deviation|Mean
1368087|NCT01589653|Secondary|Number of Hypoglycaemic Episodes During the Trial From Baseline|The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level 3.1 mmol/L [56 mg/dL]) during the trial.|Week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). 154 subjects contributed to the analysis.|||episodes|||Number
1368088|NCT01589653|Secondary|Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline|Change in FPG (laboratory values) from baseline to the end of the treatment period|Week 0, week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). A total of 150 subjects contributed to the analysis.|||mg/dL||Standard Deviation|Mean
1368089|NCT01589653|Primary|Change in HbA1c From Baseline|Change in HbA1c (%) from baseline to the end of the treatment period.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.|||percentage change in HbA1c||Standard Error|Least Squares Mean
1368090|NCT01589601|Secondary|Utilization and Cost Measured by Hospital Readmissions|We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.|Baseline (2 weeks post hospital discharge), 6 months||||Number of readmissions|||Number
1368091|NCT01589601|Secondary|Utilization and Cost Measured by the Aggregate Cost of Care|"We will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study.~Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison."|time of randomization until end of follow-up, approximately 3.5 years||2017-07-31|07/2017||||
1368110|NCT01589497|Secondary|Ethambutol PK Parameter Cmax|Ethambutol PK parameter Cmax obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
1368092|NCT01589601|Secondary|Change in FACIT-Sp|Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions.|Baseline (2 weeks post hospital discharge), 3 months, 6 months|Participants that completed the baseline, 3 month, and 6 month FACIT-Sp.|||units on a scale||Standard Deviation|Mean
1368093|NCT01589601|Secondary|After-Death Bereaved Family Member Interview - Hospice Version|A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care).|6 weeks after patient's death|Overall rating scale 6 weeks after patient's death.|||units on a scale||Standard Deviation|Mean
1368094|NCT01589601|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety|"Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months.~Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status."|Baseline (2 weeks post hospital discharge), 3 months, 6 months|Participants that completed the baseline, 3 month, and 6 month HADS.|||units on a scale||Standard Deviation|Mean
1368095|NCT01589601|Primary|Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)|"The primary endpoint is health-related quality of life as measured by the FACIT-Pal.~The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better."|Baseline, 6 months|Participants who completed the baseline and 6 month FACIT-Pal.|||units on a scale||Standard Deviation|Mean
1368096|NCT01589601|Primary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)|"The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).~The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status."|Baseline, 6 months|Participants that completed the baseline and 6 month KCCQ|||units on a scale||Standard Deviation|Mean
1368097|NCT01589510|Primary|IOP at Week 14|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.|Week 14|All patients with data for this outcome measure|||Millimeters of Mercury||Standard Deviation|Mean
1368098|NCT01589510|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure|||Patients|||Number
1368099|NCT01589510|Secondary|Percentage of Patients Who Continue Lumigan® 0.01% Treatment|Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.|Week 14|All patients|||Percentage of Patients|||Number
1368100|NCT01589510|Secondary|Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment|Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.|14 Weeks|All patients|||Percentage of Patients|||Number
1368101|NCT01589510|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure|||Patients|||Number
1368102|NCT01589510|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure|||Patients|||Number
1368103|NCT01589510|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 14|All patients with data for this outcome measure|||Eyes|Participants||Number
1368104|NCT01589510|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1368105|NCT01589497|Secondary|Moxifloxacin PK Parameter CLast at Day 14|Moxifloxacin PK parameter CLast obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14.|||ng/mL||Inter-Quartile Range|Median
1368106|NCT01589497|Secondary|Moxifloxacin PK Parameter Cmax at Day 14|Moxifloxacin PK parameter Cmax obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14|||ng/mL||Inter-Quartile Range|Median
1368107|NCT01589497|Secondary|Moxifloxacin PK Parameter CL/F at Day 14|Moxifloxacin PK parameter CL/F obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14|||L/hour||Inter-Quartile Range|Median
1368112|NCT01589497|Secondary|AUC0-24hour for Ethambutol (EMB)|PK AUCs of Ethambutol (EMB) from 0 to 24 hours obtained at Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||h*ng/mL||Inter-Quartile Range|Median
1368113|NCT01589497|Secondary|Pyrazinamide PK Parameter CLast|Pyrazinamide PK parameter CLast obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
1368114|NCT01589497|Secondary|Pyrazinamide PK Parameter Cmax|Pyrazinamide PK parameter Cmax obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
1368115|NCT01589497|Secondary|Pyrazinamide PK Parameter CL/F|Pyrazinamide PK parameter CL/F obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||L/hour||Inter-Quartile Range|Median
1368116|NCT01589497|Secondary|AUC0-24hour for Pyrazinamide (PZA)|PK AUCs of Pyrazinamide (PZA) from 0 to 24 hours obtained at Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||h*ng/mL||Inter-Quartile Range|Median
1368117|NCT01589497|Secondary|Isoniazid PK Parameter CLast at Day 14|Isoniazid (INH) PK parameter CLast obtained Day 14. The lower limit of quantification of the assay (LLOQ) for INH was 100 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 50 ng/mL.|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
1368118|NCT01589497|Secondary|Isoniazid PK Parameter Cmax at Day 14|Isoniazid PK parameter Cmax obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
1368119|NCT01589497|Secondary|Isoniazid PK Parameter CL/F at Day 14|Isoniazid PK parameter CL/F obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||L/hour||Inter-Quartile Range|Median
1368120|NCT01589497|Secondary|AUC0-24hour for Isoniazid at Day 14|PK AUCs of Isoniazid from 0 to 24 hours obtained at Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||h*ng/mL||Inter-Quartile Range|Median
1368121|NCT01589497|Secondary|Isoniazid PK Parameter CLast at Day 1|Isoniazid (INH) PK parameter CLast obtained Day 1. The lower limit of quantification of the assay (LLOQ) for INH was 100 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 50 ng/mL.|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
1368122|NCT01589497|Secondary|Isoniazid PK Parameter Cmax at Day 1|Isoniazid PK parameter Cmax obtained Day 1|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
1368123|NCT01589497|Secondary|Isoniazid PK Parameter CL/F at Day 1|Isoniazid PK parameter CL/F obtained Day 1|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||L/hour||Inter-Quartile Range|Median
1368124|NCT01589497|Secondary|AUC0-24hour for Isoniazid (INH) at Day 1|PK AUCs of Isoniazid (INH) from 0 to 24 hours obtained at Day 1|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||h*ng/mL||Inter-Quartile Range|Median
1368125|NCT01589497|Secondary|Rifampicin PK Parameter Last Concentration (CLast)|Rifampicin (RIF) PK parameter Last Concentration (CLast) obtained Day 1 and Day 14. The lower limit of quantification of the assay (LLOQ) for RIF was 40 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 20 ng/mL.|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||ng/mL||Inter-Quartile Range|Median
1368126|NCT01589497|Secondary|Rifampicin PK Parameter Maximum Plasma Concentration (Cmax)|Rifampicin PK parameter Parameter Maximum Plasma Concentration (Cmax) obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||ng/mL||Inter-Quartile Range|Median
1368127|NCT01589497|Secondary|Rifampicin PK Parameter Clearance (CL/F)|Rifampicin PK parameter Clearance (CL/F) obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||L/hour||Inter-Quartile Range|Median
1368128|NCT01589497|Secondary|Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-24hour) for Rifampicin (RIF)|Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUCs) of Rifampicin from 0 to 24 hours obtained at Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||h*ng/mL||Inter-Quartile Range|Median
1368129|NCT01589497|Secondary|Correlation Between Time to Positivity (TTP) and log10 Transformed Colony-forming Unit (CFU) Counts Per mL|Pearson correlation coefficient was used to examine the correlation between TTP and log10 CFU among all qualified samples obtained on study|Pre-entry, Day 0, Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11 and Day 14|Participants with qualified sputum samples who had results available at least one time point specified in the time-frame|||correlation coefficient|||Number
1368130|NCT01589497|Secondary|Log10 Transformed Colony-forming Unit (CFU) Count Per mL From Sputum Samples at Baseline and Day 14|The log10 CFU count per mL from sputum samples processed by standard method or decontaminated method.|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at least one time point specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
1368131|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Day 2 to Day 14|"The daily change in TTP was calculated as follows:~EBA2-14(TTP) = (TTP at day 2 - TTP at day 14)/12."|Day 2 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||hours||Inter-Quartile Range|Median
1368132|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 2|"The daily change in TTP was calculated as follows:~EBA0-2(TTP) = (baseline TTP (mean of TTP at pre-entry and day 0) - TTP at day 2)/2."|Pre-entry, Day 0 and Day 2|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||hours||Inter-Quartile Range|Median
1368133|NCT01589497|Secondary|Daily Change in log10 Colony-forming Unit (CFU) Counts Per mL Sputum From Day 2 to Day 14|"The daily change in log10 CFU/mL sputum was calculated as follows:~EBA2-14(CFU) = (log10 CFU/mL at day 2 - log10 CFU/mL at day 14)/12.~For a CFU/mL count of 0, the log10 CFU/mL was set to 0."|Day 2 and day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
1368134|NCT01589497|Secondary|Daily Change in log10 Transformed Colony-forming Unit (CFU) Counts Per mL Sputum From Baseline (Study Treatment Initiation) to Day 2|"The daily change in log10 CFU/mL sputum was calculated as follows:~EBA0-2(CFU) = (baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) - log10 CFU/mL at day 2)/2.~For a CFU/mL count of 0, the log10 CFU/mL was set to 0."|Pre-entry, Day 0 and Day 2|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
1368135|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 14|"The daily change in TTP was calculated as follows:~EBA0-14(TTP) = [baseline TTP (mean of TTP at pre-entry and day 0) – TTP at day 14]/14."|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||hours||Inter-Quartile Range|Median
1368136|NCT01589497|Primary|Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14|"The daily decrease was calculated as follows:~EBA0-14(CFU)= [baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) – log10 CFU/mL at day 14]/14. For a CFU/ml count of 0, the log10 CFU/mL was set to 0.~No formal statistical testing was conducted to compare the arms. Please refer to the explanation in the Protocol Section."|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
1368137|NCT01589484|Secondary|SWL Complications|Secondary endpoint will be SWL complications (i.e. pain, hematuria, urinary tract infection, Steinstrasse)|12 weeks after SWL||||participants|||Number
1368138|NCT01589484|Primary|Stone Clearance|After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.|12 weeks after SWL|Fragmentation|||participants|||Number
1368139|NCT01589445|Primary|Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||μU/ml||Standard Deviation|Mean
1368140|NCT01589445|Primary|Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostatic Model Assessment of Beta cell function(HOMA percent B) Analysis 2: Homeostatic Model Assessment of Insulin Sensitivity (Homa percent S)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||percentage||Standard Deviation|Mean
1368141|NCT01589445|Primary|Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||Score on a scale ( SI unit)||Standard Deviation|Mean
1370171|NCT01566162|Secondary|Smoking Questionnaire|Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).|12 weeks|Only 36 subjects who were smokers had the smoker questionnaire assessments.|||number of cigarettes smoked daily||Standard Deviation|Mean
1368142|NCT01589445|Primary|Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||percentage||Standard Deviation|Mean
1368143|NCT01589445|Primary|Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||mmol/l||Standard Deviation|Mean
1368144|NCT01589445|Secondary|Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||mg/dl||Standard Deviation|Mean
1368145|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368146|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368147|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368148|NCT01589237|Secondary|Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368149|NCT01589237|Secondary|Changes From Baseline in Glycerol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368150|NCT01589237|Secondary|Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368151|NCT01589237|Secondary|Changes From Baseline in Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368152|NCT01589237|Secondary|Changes From Baseline in Triglyceride Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
1368153|NCT01589237|Primary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death||52 weeks|Safety set (SAF) - All subjects who received at least one dose of study drug and had at least one post-baseline safety assessment in this extension study.|||Participants|||Number
1368154|NCT01588951|Primary|Relapse Free Survival|Percentage of participants alive and without relapsed disease at two years.|2 years||||percentage of participants|||Number
1368155|NCT01588821|Secondary|Time to SRE|Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)|2 years||2019-01-31|01/2019||||
1368156|NCT01588821|Secondary|Response to Cabozantinib in Bone Metastatic Disease|Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan|2 years||2019-01-31|01/2019||||
1368157|NCT01588821|Secondary|MET Amplification in Tumor Sample|Response will be correlated with specific tumor genotype (MET amplification).|2 years||2019-01-31|01/2019||||
1368158|NCT01588821|Secondary|Overall Tumor Response Rate|"The number of participants with a complete or partial response as measured by bone scan or PET-CT scan using. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD"|2 years|The 20 participants that were able to be evaluated for response. The other 17 participants had bone only disease|||Participants|||Count of Participants
1368159|NCT01588821|Secondary|Quality of Life|Quality of life as measured by pain and analgesic scores and the Functional Assessment of Cancer Therapy - General (FACT-G)|2 years||2019-01-31|01/2019||||
1368160|NCT01588821|Secondary|Rate of Skeletal-related Event (SRE)|Rate of SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)|2 years||2019-01-31|01/2019||||
1368161|NCT01588821|Primary|Number of Participants With Bone Bio-marker Response|Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.|8 Weeks|Only 19 participants were evaluable for determination of response by bone bio-markers|||Participants|||Count of Participants
1368162|NCT01588561|Secondary|Final Nicotine Levels|Final nicotine level in each participant|30 minutes post-infusion|One participant had incomplete serum nicotine results and was not included.|||ng/ml||Standard Deviation|Mean
1368163|NCT01588561|Secondary|Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine|PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.|||brain regions|||Number
1373755|NCT01523886|Secondary|Surgical Procedures at Low Pneumoperitoneum|Number of procedures which can be done with pneumoperitoneum 8 mmHg|From surgical incision to last suture has been placed, an expected average of 30 minutes.|||||||
1368164|NCT01588561|Secondary|Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History|"PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years).~The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps."|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.|||brain regions|||Number
1368165|NCT01588561|Primary|Number of Brain Regions With a Change in Brain Activity Relative to Saline|"PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course.~The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps."|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.|||brain regions|||Number
1368166|NCT01588561|Primary|Peak Nicotine Levels|Peak nicotine level in each participant|0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion|Peak nicotine levels were only measured during the nicotine study intervention. One participant had incomplete serum nicotine results and was not included.|||ng/ml||Standard Deviation|Mean
1368167|NCT01588548|Primary|Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.|Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1|All patients who were evaluable for Response analysis set for RECIST criteria|||Participants|||Number
1368168|NCT01588496|Primary|Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part B full analysis set (all enrolled participants who received at least 1 dose of investigational product)|||percent change||Standard Error|Least Squares Mean
1368169|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
1368170|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Part B full anlaysis set|||percent change||Standard Error|Least Squares Mean
1368171|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
1368172|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
1368173|NCT01588496|Secondary|Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Weeks 6 and 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
1368174|NCT01588496|Secondary|Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12||Baseline and Week 12|Part A full analysis set|||ng/mL||Standard Error|Mean
1368175|NCT01588496|Secondary|Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set|||percentage of participants|||Number
1368176|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
1368177|NCT01588496|Secondary|Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
1368178|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
1368179|NCT01588496|Secondary|Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
1368180|NCT01588496|Secondary|Part A: Change From Baseline in LDL-C at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set|||mg/dL||Standard Error|Mean
1368181|NCT01588496|Primary|Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set (all enrolled participants who received at least 1 dose of evolocumab)|||percent change||Standard Error|Mean
1368182|NCT01588470|Secondary|Change in Hemoglobin A1c|Change in hemoglobin A1c levels measured at 6 months|Baseline and 6-months Post Treatment|Enrolled subjects that meet eligibility criteria as type 2 diabetics or non diabetic subjects with coronary heart disease|||percent||Standard Deviation|Mean
1368183|NCT01588470|Primary|Myocardial Glucose Uptake|Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone|Baseline and 6-months Post Treatment|Study participants who met eligibility criteria|||uM/min/g||Standard Deviation|Mean
1368184|NCT01588470|Primary|Change in E to A Ratio|The E to A ratio is a marker of the function of the left ventricle of the heart. It represents the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by the atrial contraction (the A wave) This is measured using ultrasound-based cardiac imaging. In a healthy heart the E velocity is greater than the A velocity.|Baseline and 6-months Post Treatment||||Ratio||Standard Deviation|Mean
1368185|NCT01588444|Primary|Histologic Percentage of Vital Bone Formation|Histologic percentage of vital bone formation in bone cores|18-20 weeks after grafting||||percentage of vital bone||Inter-Quartile Range|Median
1368186|NCT01588418|Secondary|Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake|we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.|60 minutes after exenatide or placebo injection|Outcome data was not collected||||||
1368187|NCT01588418|Primary|Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism|To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.|120 minutes after exenatide or placebo injection|We studied, in the same subject, the acute effect of injection of exenatide vs placebo on brain glucose metabolism (CMRglu) after the glucose load. We used FDG PET-imaging to quantify global and regional results.|||μmol/(ml*min)||Standard Error|Mean
1368188|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)|pulmonary vascular resistance (PVR) is the resistance the right ventricle must overcome to pump blood into the pulmonary arteries. The change in PVR values from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||mmHg*min/L||Standard Deviation|Mean
1368189|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)|Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular overload. The PVRI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||mmHg*min*m^2/L||Standard Deviation|Mean
1368190|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|Both the Thermodilution (n=6) and Fick (n=29) methods were used to determine CO and in some cases both methods were utilized; however, only the Fick method was used for (CI) for the purpose of this analysis and included only 29 subjects.|||L/min/m^2||Standard Deviation|Mean
1368191|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)|Cardiac Output (CO) is the volume of blood ejected by the heart per minute, as measured by right heart catheterization. The value and change from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||L/min||Standard Deviation|Mean
1368192|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)|SaO2 measured by Arterial Blood Draw and Blood Gas Analyzer and SvO2 measured via Pulmonary Artery Catheter, are both Hemodynamics Parameters collected during right heart catheterization. Mixed venous oxygen saturation (SvO2) can help to determine whether the cardiac output and oxygen delivery is high enough to meet a patient's needs|Baseline and Week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||Percent of Oxygen saturation||Standard Deviation|Mean
1368193|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm)|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. Right Atrial Pressure (RAP) is the pressure of blood in the right atrium of the heart. Pulmonary Capillary Wedge Pressure (PCWP) is used to calculated pulmonary vascular resistance and can help guide therapeutic efficacy. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo these assessments. As such, the evaluable data at Week 24 was summarized using an N of 30 subjects, which is why the number of participants analyzed is inconsistent with the participant flow module.|||mmHg||Standard Deviation|Mean
1368204|NCT01588353|Secondary|Change From Baseline Range of Motion After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the change from baseline range of motion in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||Degrees||Standard Deviation|Mean
1368194|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.|||[h(ng/mL)]||Full Range|Median
1368195|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.|||[Tmax (h)]||Full Range|Mean
1368196|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.|||(ng/mL)||Full Range|Median
1368197|NCT01588405|Secondary|Change in Dyspnea-fatigue Index From Baseline to Week 24|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 24||||units on a scale||Full Range|Median
1368198|NCT01588405|Secondary|Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 24|The World Health Organization (WHO) Functional Classification was only conducted at baseline for one subject, because the subject discontinued the study prior to the collection of this assessment at the next visit. One subject had this assessment prior to study discontinuation.|||participants|||Number
1368199|NCT01588405|Secondary|Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24|The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and week 24||||units on a scale||Full Range|Median
1368200|NCT01588405|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||units on a scale||Full Range|Median
1368201|NCT01588405|Secondary|Change From Baseline in Six-minute Walk Distance at Week 24|The purpose of the 6MWT is to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||meters||Full Range|Median
1368202|NCT01588405|Primary|Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.|Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.|Up to 24 weeks||||participants|||Number
1368203|NCT01588353|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the time to first achieve and maintain clinical success after the last injection where clinical success was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||Days||Inter-Quartile Range|Median
1368205|NCT01588353|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the mean percent decrease from baseline degree of contracture in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||% of change from baseline||Standard Deviation|Mean
1368206|NCT01588353|Secondary|Clinical Improvement After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were clinically improved where clinically improved was defined as reduction in the contracture of the first treated joint by 50% or more from the baseline. The injection was allowed up to 3 times."|30 days after the last injection|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||% Participants||95% Confidence Interval|Number
1368207|NCT01588353|Primary|"The Percentage of Participants That Were Successfully Treated With a Successful Reduction in Contracture to 5°or Less"|"The Primary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were successfully treated where successfully treated was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|30 days after the last injection|The primary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||% Participants|||Number
1368208|NCT01588158|Secondary|Pain Scale|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At the follow-up 2 weeks after the surgery with suture removal||||units on a scale||Standard Deviation|Mean
1368209|NCT01588158|Secondary|QuickDASH|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At the follow-up 2 weeks after the surgery with suture removal||||units on a scale||Standard Deviation|Mean
1368210|NCT01588158|Secondary|Pain Scale|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At enrollment prior to surgery||||units on a scale||Standard Deviation|Mean
1368211|NCT01588158|Secondary|Expectation of Pain Relief|An 11-point ordinal scale to assess the expectation of how well the pain medication will work after surgery. The scale range is from 0-10, where 0 is not effective at all and 10 is completely effective.|1 day||||units on a scale||Standard Deviation|Mean
1368212|NCT01588158|Secondary|Pain Patients Expect After Surgery|an 11-point ordinal scale to assess the amount of pain the patients expect after surgery. The scale range is from 0-10, where 0 is no pain expected and 10 is the worst pain expected|1 day||||units on a scale||Standard Deviation|Mean
1368213|NCT01588158|Secondary|PHQ-9|Patient Health Questionnaire-9 to assess symptoms of depression. The scale range is from 0-27, where 0 is no symptoms of depression and 27 is severe depression.|1 day||||units on a scale||Standard Deviation|Mean
1368214|NCT01588158|Secondary|PSEQ|The pain self efficacy questionnaire measures a patient's belief about his/her ability to complete a task despite his/her pain. The scale range is from 0-60, where 60 represents higher self-efficacy beliefs.|1 day||||units on a scale||Standard Deviation|Mean
1368215|NCT01588158|Secondary|QuickDASH|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At enrollment prior to surgery|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||units on a scale||Standard Deviation|Mean
1368216|NCT01588158|Primary|Satisfaction With Pain Relief|an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief. The scale range is from 0-10, where 0 is complete dissatisfaction with pain relief and 10 is complete satisfaction.|at the follow-up, 2 weeks after the operation with suture removal||||units on a scale||Standard Deviation|Mean
1368217|NCT01588106|Primary|Reduction in HbA1c||Baseline, after 9 months|All participants from whom HbA1c measurements were recorded at baseline and after 9 months.|||% (unit of HbA1c)||Standard Deviation|Mean
1368218|NCT01587989|Secondary|Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score|TSQM scores were obtained by scoring participants’ responses to a 14-item questionnaire. TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.|Week 24|ITT population|||score on a scale||Standard Deviation|Mean
1368219|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores|VAS scores were obtained by scoring participants’ disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale. The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
1368220|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
1368241|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Total Iron Over 4 Weeks|Evaluation of change from Baseline for total iron was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Adjusted mean was presented as LS mean.|Baseline (pre-dose on Day 1) and at Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micromoles per Liter||Standard Error|Least Squares Mean
1368221|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire – Disability Index (HAQ-DI) Score|HAQ-DI scores were obtained by scoring participants’ responses to a 20-item questionnaire. HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do). The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
1368222|NCT01587989|Secondary|Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24|The RADAI-5 is a combined index for measuring disease activity in RA. RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months? (0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling? (0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today? (0 = no pain to 10 = unbearable pain); how would you describe your general health today? (0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning? If yes, how long did this stiffness last? (0 = no stiffness to 10 = stiffness the whole day). RADAI was calculated according to the following formula: [question (Q) 1 + Q2 + Q3 + Q4 + Q5]/5. RADAI-5 from 0-1.4 = remission.|Week 24|ITT population|||percentage of participants|||Number
1368223|NCT01587989|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24|The SDAI is a combined index for measuring disease activity in RA. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal < 1 mg/dL. CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP. SDAI < 3.3 = remission.|Week 24|ITT population|||percentage of participants|||Number
1368224|NCT01587989|Secondary|vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24|The CDAI is a combined index for measuring disease activity in RA. CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS. CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA. CDAI < 2.8 = remission.|Week 24|ITT population|||percentage of participants|||Number
1368225|NCT01587989|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 = 0.56 * √ of TJC + 0.28 * √ of SJC + 0.70 * ln ESR mm/hr + 0.014 * GH in mm VAS. DAS28 < 2.6 = remission.|Week 24|ITT population|||percentage of participants|||Number
1368226|NCT01587989|Primary|Change From Week 12 (Randomization) to Week 24 in DAS28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
1368227|NCT01587963|Primary|Efficacy of High Dose Vitamin C Therapy in Shock Patients|Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock.|30 days|Study terminated prior to data collection completion. No data analysis performed.||||||
1368228|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.|Baseline, 20 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.|||Units on a scale||95% Confidence Interval|Mean
1368229|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.|Baseline, 10 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.|||Units on a scale||95% Confidence Interval|Mean
1368240|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) in Total Iron Binding Capacity Over 4 Weeks|Evaluation of change from Baseline in total iron binding capacity was performed over 4 weeks. Baseline was recorded pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Adjusted means are presented as LS means.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micromoles per Liter||Standard Error|Least Squares Mean
1368230|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.|Baseline, immediately post administration of treatment|Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed.|||Units on a scale||95% Confidence Interval|Mean
1368231|NCT01587924|Secondary|Number of Participants With Electrocardiogram (ECG) Findings Over Period|Participants were analyzed for any abnormality in ECG and was categorized as abnormal clinically significant and abnormal and clinically insignificant. The parameters that were analyzed for ECG were atrial fibrillation, Atrial premature complex, Bigeminy, First degree AV block (PR interval > 200 msec), Incomplete right bundle branch block, Junctional rhythm, Junctional tachycardia (heart rate >100 beats/min), Left anterior hemi block (synonymous to left anterior fascicular block), Left atrial abnormality, Left axis deviation (QRS axis more negative than -30 degrees), Left bundle branch block, Left ventricular hypertrophy, Myocardial infarction, anterior, Myocardial infarction, inferior, Non-specific ST-T changes, Normal sinus rhythm, Poor R wave progression, Right atrial abnormality, Right QRS axis deviation, bundle block, ventricular hypertrophy, ST depression or abnormality, AV block, arrhythmia, short PR interval, bradycardia, tachycardia, and T-wave abnormality.|Up to 6 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1368232|NCT01587924|Secondary|Number of Participants With Abnormal Vital Signs of PCI|Vital signs include systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR). Three measurements of SBP, DBP and HR were recorded from the participant in a supine position for at least 5 minutes (allowing enough time between measurement to completely deflate and loosen the inflatable cuff). Data has been presented for vital signs with values high and low from the reference range.|Up to 6 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1368233|NCT01587924|Secondary|Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Concern (PCI)|Participants were analyzed up to 6 weeks for hematological and clinical chemistry parameters of PCI whether they had any higher or lower values than the reference range post screening. Normal alkaline phosphatase (ALP) was 0-46 U/L, aspartate amino transferase (AST) 0-42 U/L, ALP 20-125 U/L, total bilirubin 0-1.3 mg/dL, troponin 0-0.1ng/mL, Hgb 12 - 16 g/dL, platelets 140-450 G/L, creatine phosphokinase 29-168 U/L, creatinine 0.57 - 1.25 mg/dL, Potassium 3.6-5.0 mmol/L, hematocrit 38-45%; however, no participants with abnormal hematology and clinical chemistry parameters were recorded.|Up to 6 weeks (including follow-up)|Safety population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1368234|NCT01587924|Secondary|Mean Plasma Concentration of GSK1278863 and GSK1278863 Metabolites Over 4 Weeks|Each of the plasma concentration-time plot contained one plot on the untransformed scale (i.e. a linear plot) and one plot on the log transformed scale (i.e. log-linear plot). Plasma concentrations were analyzed for the study drug (GSK1278863), and its metabolites namely GSK2391220 (M2), GSK2531403 (M3), GSK2487818A (M4), GSK2506102A (M5), GSK2531398 (M6), and GSK2531401A (M13). Pharmacokinetic analysis was done on Weeks (W) 2 and 4 at a fixed timely interval of 5 hours (h) on W2 and every hour on W4. Only the data for last visit for W2 and last visit of W4 has been presented.|Up to 4 weeks|Pharmacokinetic (PK) population included all the participants who received at least one dose of the study drug and from whom at least one sample was withdrawn for PK analysis. Only those participants available at the specified time points were analyzed.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1368235|NCT01587924|Secondary|Number of Participants Discontinuing the Study Treatment Due to AEs|Discontinuation of the study drug could be due to safety-related reasons AE. The AEs responsible included anemia, gastrointestinal hemorrhage, and nausea.|Up to 4 weeks|Safety population|||Participants|||Count of Participants
1368236|NCT01587924|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Only on-treatment data has been presented.|Up to 4 weeks|Safety population.|||Participants|||Count of Participants
1368237|NCT01587924|Secondary|Number of Participants Reaching Hgb Stopping Criteria|Participants were analyzed whether they had any increase or decrease from the Baseline Hgb. Hgb increase based stopping criteria included analysis of Increase or decrease of more than or equal to (>=) 2 g/dL from the Baseline (pre-dose on Day 1) was recorded and also the participants with hemoglobin >=13 g/dL were recorded.|Up to 4 weeks|ITT population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1368238|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Reticulocytes Over 4 Weeks|Evaluation of change from Baseline for reticulocytes was a PD parameter. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage change||Standard Deviation|Mean
1368239|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Red Blood Cells (RBCs) Over 4 Weeks|Change from Baseline in RBCs was a pharmacodynamic (PD) biomarker. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Change from Baseline (pre-dose on Day 1) in RBCs was calculated over 4 weeks.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||10^12 cells per Liter (Giga cells per L)||Standard Deviation|Mean
1368242|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Transferrin Saturation Over 4 Weeks|Transferrin saturation is a medical laboratory test and is the ratio of serum iron and total iron-binding capacity, multiplied by 100 and expressed as a ratio. Evaluation of change from baseline for transferrin saturation was performed up to 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1. Model adjusted mean values are presented as LS mean values.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed..|||Ratio||Standard Error|Least Squares Mean
1368243|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Transferrin Over 4 Weeks|Evaluation of change from Baseline for ferritin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Grams per liter||Standard Error|Least Squares Mean
1368244|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) in Ferritin Over 4 Weeks|Change from Baseline (pre-dose on Day 1) in ferritin over 4 weeks was analyzed. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micrograms per liter||Standard Error|Least Squares Mean
1368245|NCT01587924|Secondary|Number of Days Spent Within Hgb Range ( ±0.5 g/dL and ±1 g/dL ) From Baseline Hgb|Time spent with Hgb within range (where range was defined as +-0.5 g/dL and +-1 g/dL from baseline Hgb ) was analyzed. Baseline value of Hgb was recorded pre-dose on Day 1.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Days||Inter-Quartile Range|Median
1368246|NCT01587924|Secondary|Residual Standard Deviation in Hgb (From the Linear Regression)|Residual standard deviation was derived by linear regression. Hgb of participants was recorded over 4 weeks|Up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
1368247|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Hematocrit Over 4 Weeks|Evaluation of change from Baseline for hematocrit over 4 weeks was performed. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
1368248|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Peak Vascular Endothelial Growth Factor (VEGF) Over 4 Weeks|Evaluation of change from Baseline for peak VEGF was analyzed up to 4 weeks. Baseline assessment was performed pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Absolute mean change and peak change from Baseline in peak VGEF were also calculated; however, only model adjusted peak change in peak VGEF from Baseline has been presented as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Nanograms per liter (ng/L)||Standard Error|Least Squares Mean
1368249|NCT01587924|Secondary|Change From Baseline for Erythropoeitin (EPO) Over Period|Evaluation of change from Baseline (pre-dose on Day 1) for EPO was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose Day 1 value. Adjusted means are presented as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Units per liter (U/L)||Standard Error|Least Squares Mean
1368250|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) in High Sensitivity C-Reactive Protein (hsCRP) Over 4 Weeks|Evaluation of change from Baseline for hsCRP was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Peak change from Baseline also was calculated; however adjusted mean change from Baseline has been presented here as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Milligrams per liter (mg/L)||Standard Error|Least Squares Mean
1368251|NCT01587924|Secondary|Evaluation of Change From Baseline in Hepcidin Over Period|Evaluation of change from baseline for hepcidin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Adjusted mean change from Baseline is presented as Least square (LS) mean.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Micrograms per liter (mcg/L)||Standard Error|Least Squares Mean
1368252|NCT01587924|Secondary|Hgb Variability Over 4 Weeks|Within participant standard deviation for Hgb acts as a measure of Hgb variability. Hgb of participants was recorded over 4 weeks.|Up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||g/dL||Standard Deviation|Mean
1368253|NCT01587924|Primary|Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment|Modeled Hgb change from Baseline over 4 weeks of treatment. Change from Baseline is the actual value of Hgb at Week 4 minus the Baseline value. For modeled change at Week 4 participants required a Baseline and two or more non missing post-baseline values. Baseline is the average of Week -2, -1 and Day 1 values. The model included fixed effects for Baseline Hgb, treatment, and treatment by day interaction. Covariate analysis for modeled Hgb change was performed. Random effects were fitted in the intercept and the slope over time.|Baseline (pre-dose on Day 1) and up to week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
1368254|NCT01587898|Secondary|Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites|Mean Steady state AUC of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For pharmacokinetic parameter assessment blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this fist sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).|Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose)|Pharmacokinetic population.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1368255|NCT01587898|Secondary|Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites|Cmax of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For assessment of Pharmacokinetics parameters blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).|Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).|All participants from whom a pharmacokinetic sample had been obtained and analyzed were included in the pharmacokinetic population.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1368256|NCT01587898|Secondary|Change From Baseline in ECG Parameters at Week 2, 4 and 6|Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Baseline ECG values were defined as measurements taken at screening. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.|Baseline (Screening), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
1368257|NCT01587898|Secondary|Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6|Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Absolute ECG parameters including PR interval, QT interval and QRS duration values at Baseline (Screening), Week 2, 4, and 6 were reported.|Baseline (Screening), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
1368258|NCT01587898|Secondary|Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6|Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. change from baseline in heart rate at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1368259|NCT01587898|Secondary|Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6|Absolute values of heart rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 were reported as vital parameter. Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1368260|NCT01587898|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6|Three measurements of SBP and DBP were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in systolic blood pressure and diastolic blood pressure at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1368261|NCT01587898|Secondary|Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6|Absolute values of systolic blood pressure and diastolic blood pressure Baseline (Day 1), Week 1, 2, 3, 4, and 6 as vital parameters were reported. Three measurements of systolic blood pressure and diastolic blood pressure were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeter mercury (mmHg)||Standard Deviation|Mean
1368262|NCT01587898|Secondary|Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||G/L||Standard Deviation|Mean
1368263|NCT01587898|Secondary|Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1), Week 1, 2, 3, 4, and 6|Safety Population. Only those participants available at the specified time points were analyzed.|||FL||Standard Deviation|Mean
1368264|NCT01587898|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet count, WBC count (absolute) at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1), Week 1, 2, 3, 4, and 6|Safety Population. Only those participants available at the specified time points were analyzed.|||10^9 cells/L||Standard Deviation|Mean
1368265|NCT01587898|Secondary|Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6|Hematology parameter reticulocyte were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1368266|NCT01587898|Secondary|Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6|Hematology parameter Mean Corpuscle Hgb Concentration was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||G/L||Standard Deviation|Mean
1368267|NCT01587898|Secondary|Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6|Hematology parameter mean corpuscle volume was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Femtolitre (FL)||Standard Deviation|Mean
1368268|NCT01587898|Secondary|Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6|Hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, WBC count (absolute) were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||10^9 cells/L||Standard Deviation|Mean
1368269|NCT01587898|Secondary|Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of urine total protein/creatinine ratio at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||MG/MMOL||Standard Deviation|Mean
1368270|NCT01587898|Secondary|Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of creatinine, direct bilirubin, indirect bilirubin, total bilirubin at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Micromol/L||Standard Deviation|Mean
1368271|NCT01587898|Secondary|Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||MMOL/L||Standard Deviation|Mean
1368272|NCT01587898|Secondary|Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6|Baseline values were recorded on Day 1 (Pre dose). If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of albumin, apolipoprotein A1, apolipoprotein total, total protein at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||G/L||Standard Deviation|Mean
1368273|NCT01587898|Secondary|Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the Baseline value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Change from Baseline values of ALT, AST, ALP and CK at Week 2, 4, and 6|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||IU/L||Standard Deviation|Mean
1368274|NCT01587898|Secondary|Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6|Absolute values of urine total protein/creatinine ratio at Baseline (Day 1), Week 2, 4, and follow-up (week 6) were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||mg/MMOL||Standard Deviation|Mean
1368275|NCT01587898|Secondary|Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including creatinine, direct bilirubin, indirect bilirubin, total bilirubin were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Micromol/L||Standard Deviation|Mean
1368276|NCT01587898|Secondary|Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Millimol per Litre (MMOL/L)||Standard Deviation|Mean
1368277|NCT01587898|Secondary|Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including albumin, apolipoprotein A1, apolipoprotein total, total protein were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed|||G/L||Standard Deviation|Mean
1368278|NCT01587898|Secondary|Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including ALT, ALP, AST, CK were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety Population. Only those participants available at the specified time points were analyzed.|||International Units per litre (IU/L)||Standard Deviation|Mean
1368279|NCT01587898|Secondary|Number of Participants Discontinuing the Study Treatment Due to AEs|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. number of participants discontinuing the study treatment due to AEs.|Up to 6 weeks|Safety Population|||Participants|||Count of Participants
1368280|NCT01587898|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 6 weeks|The Safety Population comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1368281|NCT01587898|Secondary|Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4|Blood samples for VEGF were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). Baseline was the Day 1 pre-dose value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.|Baseline (Pre-dose), week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed.|||Nanogram per litre (ng/L)||Standard Deviation|Mean
1368282|NCT01587898|Secondary|Change From Baseline in Red Blood Cells Count Over 4 Weeks|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 pre-dose), week 1, 2, 3, 4|ITT population. Only those participants available at the specified time points were analyzed.|||10^12 cells /L||Standard Deviation|Mean
1368283|NCT01587898|Secondary|Change From Baseline in Erythropoietin at Week 2 and Week 4|Blood samples for erythropoietin were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Units per litre (U/L)||Standard Deviation|Mean
1368284|NCT01587898|Secondary|Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1368285|NCT01587898|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed|||miligram per litre (mg/L)||Standard Deviation|Mean
1368286|NCT01587898|Secondary|Change From Baseline in Total Iron at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||micromol/L||Standard Deviation|Mean
1368287|NCT01587898|Secondary|Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micromol per litre (micromol/L)||Standard Deviation|Mean
1368288|NCT01587898|Secondary|Change From Baseline in Transferrin Saturation at Week 2 and Week 4|Transferrin saturation was measured as a percentage, and is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation was the pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of transferrin saturation||Standard Deviation|Mean
1368289|NCT01587898|Secondary|Change From Baseline in Transferrin at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed.|||Grams per litre (G/L)||Standard Deviation|Mean
1368358|NCT01586364|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||nmol/L||Standard Deviation|Mean
1368290|NCT01587898|Secondary|Change From Baseline in Ferritin at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||mcg/L||Standard Deviation|Mean
1368291|NCT01587898|Secondary|Change From Baseline in Hepcidin at Week 2 and Week 4|Blood samples for hepcidin were collected at Day 1 (pre-dose), Week 2 (approximately between 4 to 8 h) and Week 4 (pre-dose). Hepcidin is a regulator of iron metabolism. Baseline was the last pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Where hepcidin values were missing because the value was below the quantification limit (BQL), the BQL value was imputed.|Baseline (Pre-dose on Day 1), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Microgram per Litre (mcg/L)||Standard Deviation|Mean
1368292|NCT01587898|Secondary|Number of Participants Who Reached Hgb Stopping Criteria|The Hgb stopping criteria was defined as reaching to value <8.0 g/dL, >=8.0 - <13.0 (>= 2g/dL absolute Hgb change over 1 week ) or >=13.0 g/dL. The number of participants who reached the Hgb stopping criteria of Hgb concentration were presented.|Up to Week 4|ITT Population.|||Participants|||Count of Participants
1368293|NCT01587898|Secondary|Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb|Percentage of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study requires a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.|Up to 4 weeks|ITT population.|||Percentage of participants|||Number
1368294|NCT01587898|Secondary|Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb|Number of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study required a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.|Up to 4 weeks|ITT Population.|||Participants|||Count of Participants
1368295|NCT01587898|Secondary|Model-Adjusted Maximum Hgb Changes Over 4 Weeks|Maximum Hgb change over 4 weeks was analyzed using an ANCOVA model with terms included for treatment and baseline Hgb value. Least square mean estimates and 95% CI for each treatment group were reported. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the baseline value from the individual post-dose visit values.|Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks|ITT population.|||g/dL||Standard Error|Least Squares Mean
1368296|NCT01587898|Primary|Modeled Hgb Change From Baseline Over 4 Weeks of Treatment|Modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model. The model included fixed effects for baseline Hgb, treatment and a treatment by day interaction. Random effects was fitted in the intercept and the slope over time. All data up until investigational product discontinuation was included for Hgb efficacy evaluable participants; where efficacy evaluable was defined as having a baseline and at least 2 on-treatment Hgb assessments. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (average of Week -2, -1 and Day 1) and Week 4|The ITT population comprised of all randomized participants who received at least one dose of study medication, and had a baseline and at least one corresponding on treatment laboratory assessment. Only those participants with data available at the indicated time points were analyzed.|||gram per decilitre (g/dL)||Standard Deviation|Mean
1368297|NCT01587885|Secondary|Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire|End of Treatment Quality of Life was based on a questionnaire regarding quality-of-life issues associated with heartburn, completed by participants at the end of treatment period 1 and the end of treatment period 2.|End of treatment period 1 and end of treatment period 2|Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.|||percentage of partcipants|||Number
1368298|NCT01587885|Secondary|Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.|||participants|||Number
1368299|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.|||participants|||Number
1368300|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.|At end of study (approx. Study Day 40)|Participants in the Intent-to-Treat (ITT) population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.|||participants|||Number
1368311|NCT01587118|Primary|Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total|CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.|baseline, week 4, 8, and 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively|||units on a scale||Standard Deviation|Mean
1368301|NCT01587885|Secondary|Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time|"Onset of heartburn relief was defined as a reduction of at least one grade from baseline in the severity of heartburn following start of treatment. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:~Absent (0): Heartburn is not present.~Mild (1): Heartburn did not last long or was easily tolerated.~Moderate (2): Heartburn caused discomfort and interrupted usual activities.~Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 72 hours|"Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included."|||percentage of participants|||Number
1368302|NCT01587885|Primary|Time-to-onset of Heartburn Relief|"Time-to-onset of heartburn relief was defined as earliest time following start of treatment that participant experienced a reduction of at least one grade from baseline in the severity of heartburn. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:~Absent (0): Heartburn is not present.~Mild (1): Heartburn did not last long or was easily tolerated.~Moderate (2): Heartburn caused discomfort and interrupted usual activities.~Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 24 hours|"Participants in the modified Intent-to-Treat (mITT) population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included."|||Minutes||Inter-Quartile Range|Median
1368303|NCT01587651|Secondary|Percentage of Subjects With High On-treatment Platelet Reactivity|"Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment.~A poor response of the platelets to drug, called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events"|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population|||percentage of subjects|||Number
1368304|NCT01587651|Secondary|PRU Percent Inhibition (Calculated)|"Analysis of Mean Calculated Percent Inhibition by time point~Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU – PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population|||Percent Inhibition||Standard Error|Least Squares Mean
1368305|NCT01587651|Secondary|PRU Percent Inhibition (Device-reported)|"PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment~VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population|||percent inhibition||Standard Error|Least Squares Mean
1368306|NCT01587651|Secondary|Platelet Reactivity Index|"Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.~The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary Population|||percentage PRI||Standard Error|Least Squares Mean
1368307|NCT01587651|Secondary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment|2, 4, 24, 48 hours after first randomized dose|Primary Population|||PRU||Standard Error|Least Squares Mean
1368308|NCT01587651|Primary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.|7 days after first randomized dose|Primary Population includes all subjects who received at least 1 dose of randomized study drug and have valid PRU data at both randomization visit pre-dosing and end-of-treatment visit. A subject is considered to have valid PRU data for primary PD analyses if he/she does not have certain protocol deviations listed in Statistical Analysis Plan.|||PRU (P2Y12 Reaction Units)||Standard Error|Least Squares Mean
1368309|NCT01587274|Primary|Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score."|Baseline and one week after discharge from emergency department|Multiple imputation used to account for participants lost to follow-up|||units on a scale||Inter-Quartile Range|Median
1368310|NCT01587118|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS)|BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; highest score 126. Overall JE and Gorham DR. The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacol Bulletin 1993; 24:97-99.|Baseline, week 4, 8, 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively|||units on a scale||Standard Deviation|Mean
1368312|NCT01587105|Secondary|Physician Satisfaction|Primary care provider (PCP)'s satisfaction with the care coordination program was measured on a scale of 0-100, where the higher number indicates more satisfaction. This variable was collected at baseline and 12-months but was dropped from the 18 month follow-up as previous analysis suggested it was not relevant to the stated objective.|Baseline, 12 Months, 18 months||||units on a scale||Standard Deviation|Mean
1368313|NCT01587105|Primary|Hospital Days Per Child|Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data|Baseline, 12-Month, 18-Month||||days||95% Confidence Interval|Mean
1368314|NCT01587105|Primary|Inpatient Admissions Per Child||Baseline, 12 month, 18 month||||admissions per child||95% Confidence Interval|Mean
1368315|NCT01587105|Primary|ED Visits Per Child||Baseline, 12-month, 18-month||||ED visits||95% Confidence Interval|Mean
1368316|NCT01587105|Primary|Health Care Quality Ranking|For Healthcare Quality Rating, the construct is Parent Satisfaction. Parents were asked to rate the quality of the health care their child received. Overall range is 0-100. Higher values equal a better outcome or more satisfaction. Sub scales are not combined. The scale is considered continuous.|Baseline, 12-months, 18-months||||units on a scale||95% Confidence Interval|Mean
1368317|NCT01587105|Primary|Cost of Care|The investigators will examine whether the children in the CCM group experience decreased annual costs of care.|Baseline, 12 month, 18 month||||US Dollars||95% Confidence Interval|Mean
1368318|NCT01587079|Secondary|Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
1368319|NCT01587079|Secondary|Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
1368320|NCT01587079|Secondary|Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning post-dose daily peak flow readings on|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
1368321|NCT01587079|Secondary|Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning pre-dose daily peak flow readings|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
1368322|NCT01587079|Secondary|Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7|Change from baseline at evening 12-hour post-dose trough FEV1|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
1368323|NCT01587079|Secondary|Peak Change From Baseline IC on Day 7|Peak change from baseline IC|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
1368324|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough IC on Day 7|Change from baseline in morning pre-dose trough IC|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
1368325|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Day 7|Peak change from baseline in FEV1 Day 7|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
1368326|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7|Change from baseline in morning pre-dose trough FEV1|Day 7|MITT|||Milliliters||95% Confidence Interval|Least Squares Mean
1368327|NCT01587079|Secondary|Peak Change From Baseline in Inspiratory Capacity on Day 1|Peak change from baseline in Inspiratory Capacity|Day 1|MITT|||Milliliters||95% Confidence Interval|Least Squares Mean
1368328|NCT01587079|Secondary|Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1|Proportion of subjects achieving >=12% improvement in FEV1|Day 1|MITT|||Percentage|||Number
1368329|NCT01587079|Secondary|Time to Onset of Action (>10% Improvement in FEV1) on Day 1|Time to onset of action (>10% improvement in FEV1)|Day 1|MITT|||Percentage|||Number
1368330|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Treatment Day 1|Peak change from Baseline in FEV1 on Treatment|Day 1|MITT|||Milliliters||95% Confidence Interval|Least Squares Mean
1368331|NCT01587079|Primary|FEV1 AUC 0-12 on Day 7|FEV1 AUC 0-12|Day 7|MITT|||Liters||95% Confidence Interval|Least Squares Mean
1368332|NCT01587027|Primary|Adverse Events.|Adverse event data was evaluated for incidence and severity for 6 days.|6 days.|All enrolled participants were analyzed for adverse events.|||Events|||Number
1368333|NCT01587014|Secondary|Determine Research Subject's Baseline Temperature.|Using intermittent temperature data obtained with Prima-Temp temperature patch and wireless transmission to a receiver box and PC, researchers will compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.|0-14 days||||data unavailable|||Number
1368334|NCT01587014|Primary|Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch|The nursing staff will complete a thermometer skin site assessment daily. If the patch is removed or dislodged prior to study day 7 and 14 data points for any reason other than temporary transfer from the floor for a medical study, the nursing staff will be asked to complete an additional comfort skin site assessment. The area evaluated by the nurse will include skin in contact with both the Covidien/Kendall Lifetrace® belt and the thermometer patch.|0-14 days||||Adverse event|||Number
1368335|NCT01587001|Secondary|Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels|We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo.|8 weeks of anti-oxidant therapy||||nmol/mg protein||Standard Deviation|Mean
1368336|NCT01587001|Primary|Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels|Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)|8 weeks of anti-oxidant therapy||||pg/ml||Standard Deviation|Mean
1368337|NCT01586975|Primary|PFA1|"Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds."|3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)||||seconds||Standard Error|Mean
1368338|NCT01586962|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour||||Participants|||Number
1368339|NCT01586962|Secondary|Subject Acceptability of the Syrup|"How do you like the warming sensation you have experienced for this product?~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour||||Participants|||Number
1368340|NCT01586962|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation|1 minute||||mm||Standard Deviation|Mean
1368341|NCT01586897|Primary|Medication Safety Monitoring - ACE/ARB, Thiazide|Percentage of laboratory tests (potassium for thiazides, renal/potassium for ACE/ARBs that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of ACE/ARBs recommend renal/potassium testing and potassium testing for prescription of thiazides. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed ACE/ARB, thiazide|||percentage of tests within 4 weeks|||Number
1368342|NCT01586897|Primary|Medication Safety Monitoring - Metformin|Percentage of renal function laboratory tests that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of metformin recommend renal function testing. We chose 4- weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed metformin|||percentage of tests within 4 weeks|||Number
1368343|NCT01586897|Primary|Medication Safety Monitoring - Statins|Percentage of laboratory tests (liver function tests after a new statin prescription or a change in statin dose) that have been measured within 4 weeks following prescription. Treatment guidelines for prescription of statins recommend follow-up liver function testing. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed statins|||percentage of tests within 4 weeks|||Number
1368344|NCT01586897|Primary|Primary Effectiveness Outcome - A1c|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for HbA1c(HbA1c ≤ 7.0%).|1 year|Patients prescribed oral medications for diabetes control during the study period|||percentage of time spent at goal||Standard Deviation|Mean
1368345|NCT01586897|Primary|Primary Effectiveness Outcome - LDL|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for LDL(LDL-cholesterol ≤ 130 mg/dL for patients without cardiovascular risk and ≤ 100 mg/dl for patients with cardiovascular risk).|1 year|Patients prescribed statins during the study period|||percentage of time spent at goal||Standard Deviation|Mean
1368346|NCT01586819|Primary|Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment|The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.|Baseline and 12 weeks|Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.|||Units on a wrinkle severity scale||Inter-Quartile Range|Median
1368347|NCT01586819|Primary|Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment|The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.|Baseline and 12 weeks|Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.|||Units on a wrinkle severity scale||Inter-Quartile Range|Median
1368348|NCT01586806|Secondary|Opioid-Related Side Effects (Drowsiness)|Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.|Up to 2 days following surgery||||units on a scale||Inter-Quartile Range|Median
1368349|NCT01586806|Secondary|Postoperative Morphine Consumption|Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.|Up to 2 days following surgery||||milligrams||Inter-Quartile Range|Median
1368350|NCT01586806|Secondary|Patient Satisfaction|Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);|Up to 2 days following surgery||||units on a scale||Inter-Quartile Range|Median
1368351|NCT01586806|Secondary|NRS (Numerical Rating Scale) Pain Scores|Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.|Postoperative day 1||||units on a scale||Inter-Quartile Range|Median
1368352|NCT01586806|Primary|Patient-perceived Duration of Analgesia|After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.|Up to 2 days following surgery||||hours||95% Confidence Interval|Median
1368353|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||ng/dL||Standard Deviation|Mean
1368354|NCT01586364|Primary|Change From Baseline in SHBG Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||nmol/L||Standard Deviation|Mean
1368355|NCT01586364|Primary|Change From Baseline in FSH and LH Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||IU/L||Standard Deviation|Mean
1368356|NCT01586364|Primary|Change From Baseline in E2 Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||pg/mL||Standard Deviation|Mean
1368359|NCT01586364|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||IU/L||Standard Deviation|Mean
1368360|NCT01586364|Primary|Change From Baseline in Estradiol (E2) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||pg/mL||Standard Deviation|Mean
1368361|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.|||units||Standard Deviation|Mean
1368362|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.|||pH||Standard Deviation|Mean
1368363|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.|||units||Standard Deviation|Mean
1368364|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.|||pH||Standard Deviation|Mean
1368365|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
1368366|NCT01586364|Primary|Change From Baseline in ALT, AST and CK Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.|||U/L||Standard Deviation|Mean
1368367|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
1368368|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
1368369|NCT01586364|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||U/L||Standard Deviation|Mean
1368370|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
1368371|NCT01586364|Primary|Change From Baseline in MCV and MPV at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||fL||Standard Deviation|Mean
1368372|NCT01586364|Primary|Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
1368373|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
1368374|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
1368375|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
1368376|NCT01586364|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||fL||Standard Deviation|Mean
1368377|NCT01586364|Primary|Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
1368378|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
1368379|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
1368380|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
1368381|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
1368382|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.|||s||Standard Deviation|Mean
1368383|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
1368384|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
1368385|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.|||s||Standard Deviation|Mean
1368386|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
1368387|NCT01586364|Primary|Assessment of Breast Palpation at Visit 3|Breast palpation was used to assess breast abnormalities.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||Participants|||Number
1368388|NCT01586364|Primary|Assessment of Breast Palpation at Visit 2|Breast palpation was used to assess breast abnormalities.|Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||Participants|||Number
1368389|NCT01586364|Primary|Assessment of Cervical Pap Smear Samples (if Cervix is Intact)|Cervical Pap smear samples are used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed.|||Participants|||Number
1368390|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 3|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed.|||units on a scale||Standard Deviation|Mean
1368391|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 2|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||units on a scale||Standard Deviation|Mean
1368392|NCT01586364|Primary|Change From Baseline in BMI at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||kg/m^2||Standard Deviation|Mean
1368393|NCT01586364|Primary|Change From Baseline in Weight at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||kg||Standard Deviation|Mean
1368394|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||bpm||Standard Deviation|Mean
1368395|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||mmHg||Standard Deviation|Mean
1368396|NCT01586364|Primary|Change From Baseline in Body Mass Index (BMI) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||kg/m^2||Standard Deviation|Mean
1368397|NCT01586364|Primary|Change From Baseline in Weight at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||kg||Standard Deviation|Mean
1368398|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||bpm||Standard Deviation|Mean
1368399|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 2|Systolic blood pressure (SBP), diastolic blood pressure (DBP)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||mmHg||Standard Deviation|Mean
1368400|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
1368401|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
1368402|NCT01586364|Primary|Incidence of Adverse Events (AEs)||Week 13 (Phone Contact) to Week 56 (Visit 4)||||Participants|||Number
1368403|NCT01586338|Secondary|Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 1) state. Any change in the therapy (less use of other therapies, more use of other therapies and no change in use of other therapies) during the study was reported.|Baseline up to Week 26|FAS population.|||percentage participants|||Number
1368404|NCT01586338|Secondary|Clinical Observer Global Assessment (COGA) Score|COGA (assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant’s osteoarthritis condition. Percentage of participants with different categories of COGA score at baseline,Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.|||percentage of participants|||Number
1368405|NCT01586338|Secondary|Patient Global Assessment (PTGA) Score|PTGA (self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Percentage of participants with different categories of PTGA score at baseline, Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.|||percentage of participants|||Number
1368406|NCT01586338|Secondary|Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). Each question was measured on a scale of 0-100 mm where lower score represents lower pain (better condition) and higher score represents higher pain. WOMAC A (measure of pain during walking on a flat surface) was sum of first five items with total score ranging from 0-500 mm, Lower score represents lower pain and higher score represents higher pain. WOMAC B (Stiffness) is the sum of the sixth and seventh item, it is in the range of 0-200 mm. WOMAC C (function) is the sum of the eighth to twenty-forth item, the score is in the range of 0-1700 mm.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.|||mm||Standard Deviation|Mean
1368407|NCT01586338|Secondary|Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 8 and Week 12 (missing data imputed by LOCF)|FAS population.|||mm||Standard Deviation|Mean
1368408|NCT01586338|Primary|Overview of Adverse Events (AE)|"An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the ‘on treatment period’ (from first dose of study drug until the end of study period). Category AE included participant with both serious and non-serious AE."|Up to Week 26|Safety Set included all participants who received at least one injection of Synvisc.|||percentage of participants|||Number
1368409|NCT01586338|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])|Full Analysis Set (FAS) included all participants who received at least one injection of Synvisc®. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).|||mm||Standard Deviation|Mean
1368410|NCT01586312|Secondary|Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)|"Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.~Mean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88."|up to one year|The efficacy endpoint analysis will be based on all patients who have not committed major protocol violations, and have at least one assessment of efficacy of the end graft. 3 patients of the allogenic MSC treatment group were excluded from this analysis because of incomplete measurements.|||number of values (range 0-88)||Standard Deviation|Mean
1368411|NCT01586312|Secondary|Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)|"Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.~WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.~SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.~The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.~LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).~All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.~Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales."|up to one year||||units on a scale||Standard Deviation|Mean
1368412|NCT01586312|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months|Up to one year|"Efficacy evaluable patients (EEP): A patient has been considered evaluable whenever it has undergone the specified interventions (injection of hyaluronic acid or allogeneic MSC).~and~Safety population (SP): The population that includes all evaluable patients who have undergone one of the two study treatments."|||participants|||Number
1368413|NCT01586195|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.|Up to 42 months|Safety population defined as all enrolled participants who received any amount of vemurafenib on study.|||participants|||Number
1368414|NCT01586195|Secondary|Percentage of Participants With 12-Month Survival||Baseline to Month 12|ITT population defined as all enrolled participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1368415|NCT01586195|Secondary|Percentage of Participants With 6-Month Survival||Baseline to Month 6|ITT population defined as all enrolled participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1368416|NCT01586195|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death due to any cause. OS was summarized using Kaplan-Meier method.|Date of first treatment to date of death due to any cause (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug.|||months||95% Confidence Interval|Median
1368417|NCT01586195|Secondary|Progression-free Survival (PFS)|PFS was assessed by the investigators according to RECIST v1.1 and defined as the time interval between the date of the first treatment dose and the date of disease progression or death due to any cause, whichever occurred first. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. PFS was summarized using Kaplan-Meier method.|From start of treatment up to first documentation of disease progression or death (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug.|||months||Full Range|Median
1368418|NCT01586195|Secondary|Duration of Response|In participants with a confirmed CR or PR, duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Duration of response was summarized using Kaplan-Meier method.|From date of earliest qualifying response up to date of disease progression or death (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug. Participants with a confirmed CR or PR were analyzed.|||months||Full Range|Median
1368419|NCT01586195|Secondary|Time to BORR|In participants with a confirmed CR or PR, time to BORR was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occurred first). BORR was assessed by the investigators according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. Participants without confirmed CR or PR were censored at the date of last tumor assessment. The time to response was summarized using univariate statistics.|From start of treatment up to first documentation of confirmed CR or PR (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug. Participants with a confirmed CR or PR were analyzed.|||months||Full Range|Median
1368420|NCT01586195|Primary|Best Objective Response Rate (BORR)|BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants whose best overall response was a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper–Pearson.|Up to 42 months|ITT population defined as all enrolled participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1368421|NCT01586156|Other Pre-specified|Echocardiogram Left Ventricular Cardiac Output|We hypothesized that carvedilol would be safe and tolerable and thus that Left ventricular cardiac output, a measure of heart function, would not decrease in participants on carvedilol.|6 months||||L/min||Standard Deviation|Mean
1368422|NCT01586156|Other Pre-specified|NT-proBNP (N-terminal Pro-B Type Natriuretic Peptide)|We hypothesized that carvedilol would be safe and tolerable and thus that NT-BNP, a measure of heart failure, would not increase in participants on carvedilol.|6 months||||pg/ml||Inter-Quartile Range|Median
1368423|NCT01586156|Other Pre-specified|6 Minute Walk Test|We hypothesized that carvedilol would not worsen 6 minute walk distance.|6 months||||meters||Standard Deviation|Mean
1368424|NCT01586156|Other Pre-specified|Echocardiogram Right Ventricular Systolic Pressure (RVSP)|We hypothesized that RVSP might decrease in participants on carvedilol.|6 months||||mm Hg||Standard Deviation|Mean
1368425|NCT01586156|Secondary|Beta-Adrenergic Receptor (Alprenolol Binding Assay)|We hypothesize that use of carvedilol in patients with PAH will increase beta- adrenergic receptor availability, and this will be measurable as a increase in alprenolol binding over time of drug use.|6 months||||abritrary units||Standard Deviation|Mean
1368426|NCT01586156|Secondary|Urinary cAMP (Cyclic Adenosine Monophosphate)/Creatinine|We hypothesize that use of carvedilol in patients with PAH will increase beta adrenergic receptor function and this will be measurable as an increase in cAMP measured in the urine at 6 months in participants in dose escalation carvedilol.|6 months||||umol/g||Inter-Quartile Range|Median
1368427|NCT01586156|Primary|Cardiac Glucose Uptake in FDG-PET (Fluorodeoxyglucose-Positron Emission Tomography)|We hypothesize that use of carvedilol in patients with PAH (Pulmonary Arterial Hypertension) will decrease the cardiac glucose utilization, and this will be measurable as a drop in fasting FDG-PET standardized uptake values of the heart at 6 months as compared to baseline|6 months|Paired analyses of baseline to 6 month FDG-PET SUV (standardized uptake value) within each group.|||standardized uptake value (SUV)||Inter-Quartile Range|Median
1368428|NCT01586026|Primary|The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).|Subjects’ maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.|100 days||||adverse events|||Number
1368429|NCT01585987|Secondary|Percentage of Participants With Immune-Related Best Overall Response (irBOR)|IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group were summarized.|||percentage of participants|||Number
1368451|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through 6 Months||||percent||Inter-Quartile Range|Median
1368430|NCT01585987|Secondary|Overall Survival (OS) at Study Completion|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to end of study, April 2015 (Approximately 28 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.|||Months||95% Confidence Interval|Median
1368431|NCT01585987|Secondary|Overall Survival (OS) at Primary Endpoint|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.|||Months||95% Confidence Interval|Median
1368432|NCT01585987|Secondary|Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria|PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).|Randomization up to 91 irPFS events (Approximately 19 months )|All participants randomized to a treatment group were summarized.|||Months||95% Confidence Interval|Median
1368433|NCT01585987|Primary|Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines|irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.|Randomization up to 91 irPFS events (Approximately 19 months )|All participants who were randomized were summarized.|||Months||95% Confidence Interval|Median
1368434|NCT01585961|Secondary|Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score|Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding “extremely” limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding “not at all” limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms.|Screening to 12 Month Visit|Subset of Safety Population with non-missing AFEQT data at 12 months.|||units on a scale||Standard Deviation|Mean
1368435|NCT01585961|Secondary|Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data|||participants|||Number
1368436|NCT01585961|Secondary|Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data|||participants|||Number
1368437|NCT01585961|Secondary|Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit||12 Month Visit|Subset of Safety Population with non-missing endpoint data.|||participants|||Number
1368438|NCT01585961|Secondary|Post-procedure AF Symptoms|Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit|12 Month Visit|Subset of Safety Population with non-missing endpoint data.|||participants|||Number
1368439|NCT01585961|Secondary|Number of Patients With Repeat Ablations||1 year|Safety Population|||participants|||Number
1368440|NCT01585961|Secondary|Fluid Volume Delivered Via Ablation Catheter||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||mL||Standard Deviation|Mean
1368441|NCT01585961|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time that RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||minutes||Standard Deviation|Mean
1368442|NCT01585961|Secondary|Mean Number of Radiofrequency (RF) Applications|RF applications is defined as the number of times RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||number of applications||Standard Deviation|Mean
1368443|NCT01585961|Primary|Acute Procedural Success|Confirmation of entrance and/or exit block across all targeted pulmonary veins.|Day 0 (procedure)|Safety population|||participants|||Number
1368444|NCT01585961|Primary|Total Procedure Time||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||minutes||Standard Deviation|Mean
1368445|NCT01585961|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||minutes||Standard Deviation|Mean
1368446|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification .|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through 12 months||||participants|||Number
1368447|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through 6 months||||participants|||Number
1368448|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through Discharge||||participants|||Number
1368449|NCT01585779|Secondary|Demographic Data|Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status|Baseline||||participants|||Number
1368450|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through 12 Months||||percent||Inter-Quartile Range|Median
1368452|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through Discharge||||percent||Inter-Quartile Range|Median
1368453|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through 12 Months||||mm||Inter-Quartile Range|Median
1368454|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through 6 Months||||mm||Inter-Quartile Range|Median
1368455|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through Discharge||||mm||Inter-Quartile Range|Median
1368456|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant|Preimplant through 12 Months||||mm^2||Inter-Quartile Range|Median
1368457|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.|Preimplant through 6 Months||||mm^2||Inter-Quartile Range|Median
1368458|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.|Preimplant through Discharge||||mm^2||Inter-Quartile Range|Median
1368459|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant|Preimplant through 12 Months||||mm||Inter-Quartile Range|Median
1368460|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.|Preimplant through 6 Months||||mm||Inter-Quartile Range|Median
1368461|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.|Preimplant through Discharge||||mm||Inter-Quartile Range|Median
1368462|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through 12 Months||||mm||Inter-Quartile Range|Median
1368463|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through 6 Months||||mm||Inter-Quartile Range|Median
1368464|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through Discharge||||mm||Inter-Quartile Range|Median
1368465|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|12 months||||mmHg||Inter-Quartile Range|Median
1368466|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|6 months||||mmHg||Inter-Quartile Range|Median
1368467|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|Discharge||||mmHg||Inter-Quartile Range|Median
1368468|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.~Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through 12 Months||||participants|||Number
1368469|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.~Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through 6 Months||||participants|||Number
1368470|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.~Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through Discharge||||participants|||Number
1368471|NCT01585597|Secondary|Modified Rankin Scale 0-2|"Modified Rankin Score 0=no symptoms~no significant disability~slight disability needs help~moderate disability~moderate serve disability~severe disability 0-2 = good outcome 3-5= poor outcome"|90 days post hospitalization||||participants Modified Rankin Scal 0-2|||Number
1368472|NCT01585597|Primary|Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation|Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect|24 Hours||||participants|||Number
1368473|NCT01585584|Primary|Sustained Virologic Response (SVR) at 24 Weeks Post Treatment|Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.|24 weeks after treatment|Patients who completed full course of treatment|||participants|||Number
1368474|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||kg/m^2||Standard Deviation|Mean
1368475|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||kg||Standard Deviation|Mean
1368476|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||bpm||Standard Deviation|Mean
1368477|NCT01585558|Primary|Change From Baseline in DBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
1368478|NCT01585558|Primary|Change From Baseline in SBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
1368479|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 26|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||kg/m^2||Standard Deviation|Mean
1368480|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||kg||Standard Deviation|Mean
1368481|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||bpm||Standard Deviation|Mean
1368482|NCT01585558|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
1368483|NCT01585558|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
1368484|NCT01585558|Primary|Change From Baseline in Specific Gravity of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||units||Standard Deviation|Mean
1368485|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||pH||Standard Deviation|Mean
1368486|NCT01585558|Primary|Change From Baseline in Specific Gravtiy of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.|||units||Standard Deviation|Mean
1368487|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.|||pH||Standard Deviation|Mean
1368488|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368489|NCT01585558|Primary|Change From Baseline in Hemoglobin Levels||Baseine to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||g/dL||Standard Deviation|Mean
1368490|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
1368491|NCT01585558|Primary|Assessment of Hematology Test Values|Change from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
1368492|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368493|NCT01585558|Primary|Change From Baseline in Hemogobin Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||g/dL||Standard Deviation|Mean
1368494|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
1368495|NCT01585558|Primary|Assessment of Hematology Tests|Change from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
1368496|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
1368497|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
1368498|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||s||Standard Deviation|Mean
1368499|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368500|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368501|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||mg/dL||Standard Deviation|Mean
1368502|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368503|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||s||Standard Deviation|Mean
1368504|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368505|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368506|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||mg/dL||Standard Deviation|Mean
1368507|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
1368508|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
1368509|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
1368510|NCT01585558|Primary|Assessment of Mammography|Mammography was done for the detection of characteristic masses and microcalcifications in the breast.|Week 52 (Visit 6)||||Participants|||Number
1368511|NCT01585558|Primary|Change From Baseline in SHBG Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||nmol/L||Standard Deviation|Mean
1368512|NCT01585558|Primary|Change From Baseline in FSH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
1368513|NCT01585558|Primary|Change From Baseline in LH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
1368514|NCT01585558|Primary|Change From Baseline in E2 Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||pg/mL||Standard Deviation|Mean
1368515|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
1368516|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
1368517|NCT01585558|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||nmol/L||Standard Deviation|Mean
1368518|NCT01585558|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
1368519|NCT01585558|Primary|Change From Baseline in Luteinizing Hormone (LH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
1368520|NCT01585558|Primary|Change From Baseline in Estradiol (E2) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||pg/mL||Standard Deviation|Mean
1368521|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||Units on a scale||Standard Deviation|Mean
1368522|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||Units on a scale||Standard Deviation|Mean
1368523|NCT01585558|Primary|Assessment of Endometrial Safety With a TVU|Mean change in endometrial thickness from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 52 out of 69 subjects in the ospemifene 60 mg group, and 30 out of 49 subjects in the placebo group were analyzed.|||mm||Standard Deviation|Mean
1368603|NCT01584648|Secondary|Number of Participants With Incidence of Squamous Cell Carcinoma|Participants were evaluated for the event of squamous cell carcinoma including Keratoacanthoma.|From Baseline up to end of study (average of 9 study months)|Safety Population|||Number of events|||Number
1368524|NCT01585558|Primary|Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)|Mean change in endometrial thickness from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 50 out of 62 subjects in the ospemifene 30 mg group, 60 out of 69 subjects in the ospemifene 60 mg group, and 37 out of 49 subjects in the placebo group were analyzed.|||mm||Standard Deviation|Mean
1368525|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 52 (Visit 6)||||U/L||Standard Deviation|Mean
1368526|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 26 (Visit 5)||||U/L||Standard Deviation|Mean
1368527|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 52 (Visit 6)||||percent change||Standard Deviation|Mean
1368528|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 26 (Visit 5)||||percent change||Standard Deviation|Mean
1368529|NCT01585558|Primary|Assessment of Endometrial Biopsy|Assessments were based on Blaustein’s classification.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
1368530|NCT01585558|Primary|Assessment of Cervical Pap Smear Samples|Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
1368531|NCT01585558|Primary|Incidence of Adverse Events (AEs)||Week 20 (Phone Contact) to Week 56 (Visit 7)||||Participants|||Number
1368532|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Final Study Visit||||participants|||Number
1368533|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Month 3||||participants|||Number
1368534|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline||Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.|||participants|||Number
1368535|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline||Month 3||||participants|||Number
1368536|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.|||participants|||Number
1368537|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Month 3||||participants|||Number
1368538|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline|The mean change is reported in micrograms (μg).|Final Study Visit|One finasteride participant's cortisol lab value could not be calculated due to Cortisol, Urine <1.5 ng/mL.|||μg||Standard Deviation|Mean
1368539|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline|The mean change is reported in micrograms (μg).|Month 3||||μg||Standard Deviation|Mean
1368540|NCT01585441|Secondary|Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Final Study Visit||||ng/dL|Participants|Standard Deviation|Mean
1368541|NCT01585441|Secondary|Change in Serum Testosterone Concentration at Month 3 Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Month 3||||ng/dL||Standard Deviation|Mean
1368542|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Final Study Visit||||pg/mL||Standard Deviation|Mean
1368543|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Month 3||||pg/mL||Standard Deviation|Mean
1368544|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Final Study Visit||||μm|Participants|Standard Deviation|Mean
1368545|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Month 3||||μm|Participants|Standard Deviation|Mean
1368546|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Final Study Visit||||decibels|Participants|Standard Deviation|Mean
1368547|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Month 3||||decibels|Participants|Standard Deviation|Mean
1368548|NCT01585441|Secondary|Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline|Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the “Edit Segmentation” function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.|Month 3||||percent change|Participants|Standard Deviation|Mean
1368620|NCT01584479|Secondary|Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories||10 and 15 years|||||||
1368549|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Final Study Visit||||ETDRS letters|Participants|Standard Deviation|Mean
1368550|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Month 3||||ETDRS letters|Participants|Standard Deviation|Mean
1368551|NCT01585441|Secondary|Number of Participants Who Withdrew From the Study||Duration of the study, up to 1.5 years||||participants|||Number
1368552|NCT01585441|Secondary|Number of Participants With Adverse Reactions Related to the Investigational Product|The outcome measure refers only to events that were classified as related to the investigational product.|Duration of the study, up to 1.5 years||||participants|||Number
1368553|NCT01585441|Primary|Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline|This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the “Edit Segmentation” function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume.|Month 3||||participants|Participants||Number
1368554|NCT01585441|Primary|Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.|This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Month 3||||participants|Participants||Number
1368555|NCT01585428|Secondary|Number of Patients With Serious and Non-serious Adverse Events|Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.|51 months and 18 days||||Participants|||Count of Participants
1368556|NCT01585428|Primary|Number of Participants With an Objective Clinical Response|Patients must have a partial response (PR) or complete response (CR) at least 4 months after cell infusion to count towards clinical response. Clinical response is assessed by the Response Criteria in Solid Tumors (RECIST) v1.0. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete response is disappearance of all target lesions. Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|4 months after cell infusion||||Participants|||Count of Participants
1368557|NCT01585324|Secondary|Number of Participants With Thrombocytopenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1368558|NCT01585324|Secondary|Number of Participants With Neutropenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1368559|NCT01585324|Secondary|Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1368560|NCT01585324|Secondary|Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR|The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||g/L||Standard Deviation|Mean
1368561|NCT01585324|Secondary|Number of Participants With Decrease in Hemoglobin|The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1368562|NCT01585324|Primary|Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR|Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Baseline and Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||grams per liter (g/L)||Standard Deviation|Mean
1368563|NCT01585324|Primary|Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment|SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.|24 weeks after the end of treatment (72 weeks)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1368621|NCT01584479|Secondary|Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.||10 and 15 years|||||||
1368622|NCT01584479|Secondary|Change in Periodontal Surgery Claims||10 and 15 years|||||||
1368564|NCT01585272|Secondary|Percentage of Patients Successfully Titrated to Rivastigmine Patch 10 cm^2|The percentage of patients successfully titrated to rivastigmine patch 10 cm2|Baseline through week 52|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.|||Percentage of participants|||Number
1368565|NCT01585272|Secondary|The Discontinuation Rate Due to the Treatment Switching From Oral Capsule to Rivastigmine Patch Treatment|The discontinuation rate due to the treatment switching from oral capsule to patch treatment. For patients who discontinue earlier due to intolerance of patch treatment, the proportion will be analyzed. Both the discontinuation rate of 5 cm2 and 10 cm^2 patch therapy will be presented.|Baseline through week 52|Of the patients treated, N=121, number of patients analyzied were those who received 5cm patch (n=114) and those who received 10cm patch (n=96)|||Participants|||Number
1368566|NCT01585272|Secondary|Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)|The changes in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) of patients with Alzheimer’s disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm^2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. ADAS-Cog has been used as the major cognitive measure of anti-dementia drugs. The total score range is 0 to 70 points, with higher scores indicating greater cognitive impairment. The assessments will be conducted at Visit, 2, 8, 11 and 17 (Week 4 (baseline), 16, 28 and 52).|Baseline, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy.|||Score||Standard Deviation|Mean
1368567|NCT01585272|Secondary|Change From Baseline in Mini-Mental Status Examination (MMSE)|The changes in Mini-Mental Status Examination (MMSE) of patients with Alzheimer’s disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. MMSE is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial ability and language. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. The assessments will be conducted at Visit 1, 2, 8, 11 and 17 (screening, Week 4 (baseline), 16, 28 and 52).|Baselin, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy|||Score||Standard Deviation|Mean
1368568|NCT01585272|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through the first 28-week treatment period|Baseline through week 28|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.|||Participants|||Number
1368569|NCT01585246|Primary|Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose|Dose limiting toxicities was defined as the Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher for gastrointestinal symptoms (nausea, gastritis, anorexia). The maximum tolerated dose (MTD) was established among 320mg, 640mg,or 960mg, at which less than 10% of men report less than a grade 2 of gastrointestinal symptoms.|Baseline to Week 12|Number of participants reporting adverse events at grade 2 or higher, according to the TITE-CRM algorithm|||participants|||Number
1368570|NCT01585246|Primary|Efficacy|Evaluate preliminary efficacy of Saw Palmetto at the MTD as compared to the placebo group with respect to Health-Related Quality of life (HRQOL) including physical functioning and symptoms. The outcomes were measured using 1) the International Prostate Symptoms Score (IPSS) and 2) the total and subscales of the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The IPSS which ranges from 0-35. A lower score indicates better symptoms. The FACT-P has the following subscores and ranges: emotional well-being (0-24), functional well-being (0-28), physical well-being (0-28), social well-being (0-28), and prostate-specific concerns (0-48). The FACT-P total is comprised of the sum of the subscales and ranges from 0-156. For the FACT-P, a higher score indicates better quality of life. Each values was created as an average over time from a linear mixed effects model that adjusted for baseline values.|HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.||||units on a scale||Standard Deviation|Least Squares Mean
1368571|NCT01585246|Primary|Feasibility|Assess a Saw Palmetto supplementation protocol for feasibility by evaluation if at least 70% of eligible men consent, and if at least 70% of men enrolled at each dose complete the study.|Baseline to Week 12 for each phase.|Number of men who started|||Participants|||Count of Participants
1368572|NCT01585207|Primary|Global Severity Score on the Y-GTSS|The Global Severity score is the sum of the Total Tic score and the TD Impairment score. It is rated by the Investigator on the Yale Global Tic Severity Score ( Y-GTSS, a widely accepted measure of drug efficacy in TD. Scale from 0- 100. Higher score indicates more impairment.|weekly from baseline to end of study (10weeks)||||units on a scale||Full Range|Mean
1368573|NCT01585168|Primary|"Change in Blood Oxygenation Level Dependent (BOLD) Activation in Anterior Cingulate Cortex During Loss Condition of Monetary Incentive Delay (MID) Task Between Placebo and Study Medication"|"All participants completed the fMRI Monetary Incentive Delay task on each study day. During the task, participants needed to select the correct response during win and lose conditions by pressing a button on a button box in the MRI. Participant’s BOLD activation response (A measurement of oxygen level that is released to neurons since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen to perform the tasks.) was measured while they performed the task in MRI scanner."|4 hours post intervention on each study day, separated by 1 week to 1 month|The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment.|||mean of voxel wise BOLD response||Standard Deviation|Mean
1368574|NCT01585168|Secondary|Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication|All participants completed the EDT task approximately 3 hours post drug administration on both study visits. Study days were approximately 1 week to 1 month a part. EDT is a delay-discounting task that exposes participants to choice consequences during test administration. The EDT involves multiple blocks of choices, one for each delay. Choices are made between a standard amount that is delivered immediately and is certain and a probable amount that is delayed and uncertain.|3 hours post intervention on each study day, separated by 1 week to 1 month||||responses||Standard Deviation|Mean
1368623|NCT01584479|Secondary|Change in Total Periodontal Claims During the Monitoring Period||10 and 15 years|||||||
1368575|NCT01585168|Secondary|Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication|All participants completed the BART task approximately 3 hours post drug administration on both study visits. Study days were approximately 1 week to 1 month a part. BART is a computer decision-making task that measures risk taking. Participants are presented with a series of “balloons.” The object is to earn as much money as possible by pumping the balloon without popping it. The point of explosion varies from trial to trial and costs participants the money they have earned in that trial.|3 hours post intervention on each study day, separated by 1 week to 1 month|Participants with a family history of alcoholism (family history positive) and without a history of alcoholism (family history negative) who completed BART task.|||total pumps||Standard Deviation|Mean
1368576|NCT01585168|Primary|"Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During Win Monetary Incentive Delay (MID) Task Between Placebo and Study Medication"|"All participants completed the fMRI Monetary Incentive Delay task on each study day. During the task, participants needed to select the correct response during win and lose conditions by pressing a button on a button box in the MRI. Participant’s BOLD activation response (A measurement of oxygen level that is released to neurons since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen to perform the tasks.) was measured while they performed the task in MRI scanner."|4 hours post intervention on each study day, separated by 1 week to 1 month|The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment.|||mean of voxel wise BOLD response||Standard Deviation|Mean
1368577|NCT01585129|Secondary|Duration of Hospital Stay After Cesarean Delivery|This is the duration of hospital stay (in days) after their cesarean delivery.|Up to 7 Days||||days||95% Confidence Interval|Mean
1368578|NCT01585129|Secondary|Number of Participants With Infection-related Complications|Infection related complications will include common complications attributed to infections there are not the primary outcome (endometritis). This will include infections of the wound and pelvic abscesses.|7 days post-partum||||Participants|||Count of Participants
1368579|NCT01585129|Primary|Number of Paricipants With Endometritis|Endometritis is defined as uterine infection and is diagnosed by maternal temp > 38.0C on two occasions over a 4 hour period or any temp > 39.0C after delivery > 12 hours after delivery. Endometritis will be managed per currently accepted endometritis protocol - (Amp 2 gQ6, Gentamicin 5 mg/kg q24, Clindamycin 900 mg q8).|7 days post-partum||||Participants|||Count of Participants
1368580|NCT01585038|Secondary|Oxidative Stress Markers|Change in F2-isoprostane levels|Change from baseline to 4 weeks||||pg/mL||Standard Deviation|Mean
1368581|NCT01585038|Secondary|Endothelial Activation Markers|Change in soluble vascular cell adhesion molecule-1 levels|Change from baseline to 4 weeks||||pg/mL||Standard Deviation|Mean
1368582|NCT01585038|Secondary|Inflammatory Markers|Change in high sensitivity C-reactive protein levels|Change from baseline to 4 weeks||||mg/L||Standard Deviation|Mean
1368583|NCT01585038|Primary|Change in Flow-mediated Dilation of the Brachial Artery|This is a measure of in vivo endothelial function|Change from baseline to 4 weeks||||absolute percentage change||Standard Deviation|Mean
1368584|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population||||||
1368585|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
1368586|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
1368624|NCT01584479|Secondary|Change in Total Dental Claims During Monitoring Period||10 and 15 years|||||||
1368587|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population||||||
1368588|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
1368589|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Week 1 and Week 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
1368590|NCT01584843|Secondary|Duration of Effect|Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after injection]/absolute angle [strabismus angle at Baseline minus the strabismus angle at maximum change]) multiplied by 100.|Up to Week 48 after the final injection of the FTP (up to Study Week 52)|FAS1 Population|||Days||95% Confidence Interval|Median
1368591|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population|||Percent change in prism dioptre||Standard Deviation|Mean
1368592|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP|FAS1 Population|||Percent change in prism dioptre||Standard Deviation|Mean
1368593|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle ([strabismus angle at Baseline minus strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population|||Percent change in prism dioptre||Standard Deviation|Mean
1368594|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 population.|||prism dioptre||Standard Deviation|Mean
1368595|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position were summarized for observed cases at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups).|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
1368596|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position at Week 1 and Week 4 of the FTP were summarized for observed cases without imputation of missing values.|Weeks 1 and 4 of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
1368597|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population: all participants who were included in the FAS1 Population, received reinjection of the investigational product, and had at least one efficacy assessment after the reinjection|||prism dioptre||Standard Deviation|Mean
1368598|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
1368599|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 1minus the value at Baseline.|Baseline and Week 1 of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
1368600|NCT01584843|Primary|Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters [m]) and the near-view strabismus angle (measured at a distance of 33 centimeters [cm]). Every participant’s evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline.|Baseline and Week 4 of the FTP|Full Analysis Set (FAS1) Population: all participants who were randomized and had at least one post-Baseline efficacy assessment. Values were summarized for OC of the FTP without imputation of missing values. Only those participants available at the specified time points were analyzed.|||prism dioptre||Standard Deviation|Mean
1368601|NCT01584648|Secondary|Plasma Concentrations of Dabrafenib and Its Metabolites|Blood samples were collected for PK analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Plasma concentrations of dabrafenib (GSK2118436) and its metabolites (GSK2285403, GSK2298683, and GSK2167542) were determined using the currently approved analytical methodology.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|PK Population.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1368602|NCT01584648|Secondary|Plasma Concentrations of Trametinib|Blood samples were collected for Pharmacokinetic (PK) analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|Pharmacokinetic (PK) Population: all participants included in the safety population for whom a PK sample was obtained and analyzed. Only participants with data available at the specified time points were analyzed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1368604|NCT01584648|Secondary|Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as any increase; no change; and any decrease and as 0-10 decrease, 10 - 19 decrease, >= 20 decrease, >=10 decrease and >= lower limit of normal (LLN), >=10 decrease and <LLN, >10 decrease and <LLN, >= 20 decrease and >= LLN, >= 20 decrease and <LLN. Only those participants with LVEF values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1368605|NCT01584648|Secondary|Number of Participants With a Worse-case On-therapy Change From Baseline in the Bazett's QTc to Grade 2 or Grade 3|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. Bazett's QTc is categorized as: Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (>=501 msec). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with Bazett's QTc values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1368606|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1368607|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with blood pressure values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1368608|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. Only those participants with heart rate values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1368609|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Clinical Chemistry Parameters|Clinical chemistry tests where the toxicity grade is not defined by NCI-CTCAE includes chloride, creatinine clearence, lactate dehydrogenase, urea, protein and carbon dioxide. Change from Baseline is categorized as decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1368610|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Hematology Parameters|Hematology tests where the toxicity grade is not defined by NCI-CTCAE includes basophils, eosinophils and monocytes. Change from Baseline is categorized as a decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1368611|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Hematology Parameters|Hematology data were summarized according to NCI-CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe, or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1368612|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters|Clinical chemistry data were summarized according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, glucose, potassium, sodium, creatinine and phosphate. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1368613|NCT01584648|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Protocol specific SAEs included: ALT≥3XULN and total bilirubin ≥2XULN (35% direct) or ALT ≥3XULN and INR >1.5 (if INR is measured); any new malignancy with a histology different from the primary tumor; left ventricular ejection fraction that met stopping criteria; central serous retinopathy or retinal vein occlusion; pyrexia accompanied by ≥grade 3 hypotension, or hypotension that is clinically significant as judged by the investigator, dehydration requiring IV fluids, or severe rigor/chills. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the time the first dose of study treatment administered until 30 days after discontinuation of study treatment (average of 9 study months)|Safety Population: all randomized participants who received at least one dose of study medication and were based on the actual treatment received if this differed from that to which the participant was randomized.|||Participants|||Number
1368614|NCT01584648|Secondary|Duration of Response for Participants With a Confirmed Response (Complete Response or Partial Response)|Duration of response is defined as the time (in months) from the first documented complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm) until disease progression (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. PD was based on the radiological evidence by investigator.|From the time of the first documented response (CR or PR) until disease progression (average of 9 study months)|ITT population. Only those participants with a confirmed CR or PR were analyzed (with or without measurabe disease at Baseline).|||Months||95% Confidence Interval|Median
1368615|NCT01584648|Secondary|Number of Participants With a Confirmed Response (Complete Response or Partial Response)|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|From randomization until the first documented complete response or partial response (average of 9 study months)|ITT Population. Only participants with measurable disease at Baseline per RECIST were analyzed.|||Participants|||Number
1368616|NCT01584648|Secondary|Overall Survival (OS)|OS is defined as the interval of time (in months) between the date of randomization and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From randomization until death due to any cause (average of 9 study months)|ITT Population|||Months||95% Confidence Interval|Median
1368617|NCT01584648|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time (in months) from the date of randomization to the first documented occurrence of PD or death. Investigator PFS was summarized per response evaluation criteria in solid tumors (RECIST, version 1.1) which is a set of published criteria defining when cancer patients improve (respond), stay the same (stable) or worsen (progress). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. For participants who had not progressed or died at the time of the analysis, censoring was performed at the last adequate disease assessment.|From randomization until the earliest date of disease progression (PD) or death due to any cause (average of 9 study months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not they received the study treatment. Any participant who received a treatment randomization number was considered to have been randomized.|||Months||95% Confidence Interval|Median
1368618|NCT01584544|Primary|Number of Participants Experienced Dose Limited Toxicity|Dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment|up to 7 weeks from start of the treatment||||participants|||Number
1368619|NCT01584518|Primary|Length of Stay|The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay|From date of admission until date of discharge, assessed up to 1 month||||days||Standard Deviation|Mean
1368636|NCT01584388|Primary|No Disease Flares During Rituximab Treatment Phase|"Disease flare measured by responder Index score:~At each assessment, the physician enters a 0-4 score after the organ/site listed with:~0 = Normal or resolved~= Improved but still present~= Persistent (still active; unchanged from previous visit)~= New or recurrent disease activity while patient is off treatment~= Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no)"|Month 6|number of subjects without disease flares during baseline to 6 month of treatment|||Participants|||Count of Participants
1368637|NCT01584388|Primary|Cumulative Glucocorticoid Use at Baseline and 6 Months|Cumulative glucocorticoid therapy between baseline and 6 months.|6 months|cumulative glucocorticoid use at 6 and compare them to baseline using paired T tests.|||mg||Full Range|Mean
1368638|NCT01584388|Primary|IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment|"The IgG4-RD RI is then calculated by adding the individual organ scores.At each assessment, the physician enters a 0-4 score after the organ/site listed with:~0 = Normal or resolved~= Improved but still present~= Persistent (still active; unchanged from previous visit)~= New or recurrent disease activity while patient is off treatment~= Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no)~The Responder Index ranges from 0-60."|6 months||||units on a scale||Standard Deviation|Mean
1368639|NCT01584232|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used.|||percentage of participants|||Number
1368640|NCT01584232|Secondary|Change From Baseline in Body Weight at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
1368641|NCT01584232|Secondary|Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects and baseline SMBG as a covariate.|Baseline, Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1368642|NCT01584232|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1368643|NCT01584232|Secondary|Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.|||percentage of participants|||Number
1368644|NCT01584232|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
1368645|NCT01583894|Primary|Multi-site Pain Index|"Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.~MSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions."|single-visit|MSPI was calculated using multiple pain descriptors which were obtained from pain drawings. 810 of the 813 patients that completed the study provided complete pain drawing data, and so MSPI could be calculated only in 810 patients.|||units on a scale||Standard Deviation|Mean
1368646|NCT01583647|Primary|Plasma Cmax of Nicotinuric Acid (NUA)||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
1368647|NCT01583647|Primary|Total Urinary Excretion of Niacin and Niacin Metabolites||Predose on Day 1 up to 72 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
1368648|NCT01583647|Primary|Plasma Maximum Concentration (Cmax) of Laropiprant||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
1368649|NCT01583647|Primary|Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant||Predose Day 1 up to 24 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
1368650|NCT01583543|Secondary|Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event|Adverse events were graded according to CTCAE v.4 (Common Terminology Criteria for Adverse Events). Events are graded on a scale of 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal. Only events that are clinically significant and which the treating investigator considers to be related to administration of olaparib are counted for this outcome measure.|2 years||||Participants|||Count of Participants
1368651|NCT01583543|Secondary|Overall Survival|Number of patients survived for 2 years after enrolling onto this study.|Two years||||Participants|||Count of Participants
1368652|NCT01583543|Secondary|Progression-Free Survival|Number of patients with progression free survival after two years from starting the trial.|Two years||||Participants|||Count of Participants
1368653|NCT01583543|Primary|Objective Response Rate of Olaparib|"Number of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1.~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years||||Participants|||Count of Participants
1368654|NCT01583530|Secondary|Number of Participants Who Experienced Adverse Events|Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).|Up to Day 119|Analyses were performed on the as-treated population, defined as the set of all participants who received at least 1 partial or full dose of treatment with the assignment to treatment group that was based on the actual treatment administered to the participants.|||participants|||Number
1368655|NCT01583530|Secondary|Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage bioavailability||90% Confidence Interval|Mean
1368656|NCT01583530|Secondary|Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
1368657|NCT01583530|Secondary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
1368658|NCT01583530|Secondary|Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1370375|NCT01564407|Primary|Number of Participants With Serious Adverse Events Reported|The evaluation of tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events.|12 weeks||||participants|||Number
1368659|NCT01583530|Primary|Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage bioavailability||90% Confidence Interval|Mean
1368660|NCT01583530|Primary|Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
1368661|NCT01583530|Primary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
1368662|NCT01583530|Primary|Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1368663|NCT01583530|Secondary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
1368664|NCT01583530|Primary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Full Range|Median
1368665|NCT01583452|Secondary|Time to Tolerate Feedings (Oral Intake)|The time between the end of surgery to the moment in which the patient can tolerate the intake of fluids or any type of food.|End of surgery to oral intake tolerance (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
1368666|NCT01583452|Secondary|Time to First Bowel Movement|The time between the end of surgery and the moment in which the patient presents first bowel movement.|End of surgery to first bowel motion (from 1 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
1368667|NCT01583452|Secondary|Time to First Flatus|The time between the end of surgery and the moment in which the patient passes first flatus|End of surgery to first flatus (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
1368668|NCT01583452|Primary|Post-Operative Hospital Stay|The time between the end of surgery and hospital discharge, measured in hours|End of surgery to hospital discharge (from 4 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
1368669|NCT01583374|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period|A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|During placebo-controlled period; up to week 24|Safety population includes all participants who were randomized and received at least one dose of IP. Includes data through Week 16 for placebo-treated and apremilast 20 mg BID treated participants who escaped early and data up to Week 24 for all other participants.|||participants|||Number
1368670|NCT01583374|Secondary|Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 260|The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) is a scoring method used by experts to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine.|Baseline and Week 260||2019-12-31|12/2019||||
1368671|NCT01583374|Secondary|Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104|The modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) is a scoring method used by experts to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine.|Baseline and Week 104||2019-12-31|12/2019||||
1368672|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24|The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) are measured and normalized on 0 to 10 unit NRS. The average of these scores is the total BASMI score, with a higher value indicating more severe limitation in spinal mobility|Baseline and Week 24||2019-12-31|12/2019||||
1368673|NCT01583374|Secondary|Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement|Baseline and Week 24||2019-12-31|12/2019||||
1368674|NCT01583374|Secondary|Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) at Week 24|The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis (AS) on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consists of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0–18 with higher scores indicating worse quality of life|Baseline and Week 24||2019-12-31|12/2019||||
1368675|NCT01583374|Secondary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) at Week 24, Compared Between Apremilast 20 mg and Placebo|"ASAS 20 is defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:~Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active~Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = “no pain” and the right-hand box = “most severe pain”~Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability~Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 24||2019-12-31|12/2019||||
1368676|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a participant self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3)peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease.|Baseline and Week 24||2019-12-31|12/2019||||
1368677|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a participant self-administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses a participants' degree of mobility and functional ability. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting the participants' ability to cope with everyday life. The participant will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 10 questions, on which the left-hand box of 0 represents “easy,” and the right-hand box represents “impossible.” The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability.|Baseline and Week 24||2019-12-31|12/2019||||
1368678|NCT01583374|Primary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) for the Comparison Between Apremilast 30 mg BID and Placebo at 16 Week of Treatment|"ASAS 20 is defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:~Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active~Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = “no pain” and the right-hand box = “most severe pain”~Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability~Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 16|The mITT population who were randomized to apremilast (APR) 30 mg BID or placebo and received at least one dose of investigational product. The APR 20mg dose was an exploratory endpoint.|||percentage of participants|||Number
1368679|NCT01583218|Secondary|mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT: Between randomization and Day 42 (max)|The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
1368680|NCT01583218|Secondary|mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 2: Between randomization and Day 42 (max)|"Cohort 2 (encompasses both participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components."|||Percentage of Participants||95% Confidence Interval|Number
1368681|NCT01583218|Secondary|mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 1: Between randomization and Day 42 (max)|Cohort 1 (participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
1368682|NCT01583218|Primary|Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication|Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.|Between randomization and Day 49 (max)|Safety population which consisted of all participants who had taken at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1368683|NCT01583218|Primary|mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT: Between randomization and Day 47 (max)|The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
1368684|NCT01583218|Primary|mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 2: Between randomization and Day 47 (max)|"Cohort 2 (encompasses both participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components."|||Percentage of Participants||95% Confidence Interval|Number
1368685|NCT01583218|Primary|Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 1: Between randomization and Day 47 (max)|Cohort 1 (participants with baseline D-dimer ≥ 2 x upper limit normal (ULN) as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
1368686|NCT01583101|Primary|The Number of Prompts That Were Responded to|The main outcome of interest is whether or not a prompt was answered (discussed/not discussed).|1 year||||Participants|||Count of Participants
1368687|NCT01582971|Primary|Use of Unscheduled Health Service|Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.|Week 11|Participant outcome data collected at week 11|||unscheduled visits||Standard Deviation|Mean
1368688|NCT01582971|Primary|Quality of Life Index (QLI)|The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.|Week 5 and week 11|Participant outcome data collected at week 5 and week 11|||units on a scale||Standard Error|Least Squares Mean
1368689|NCT01582971|Primary|Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0|"PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.~PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.~Higher scores representing better outcomes in each subscale."|Week 5 and week 11|Participant outcome data collected at week 5 and week 11|||units on a scale||Standard Error|Least Squares Mean
1368690|NCT01582971|Primary|The M.D. Anderson Symptom Inventory (MDASI)|"The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived.~Higher symptom severity and interference scores represent worse outcome."|Week 5 and week 11|Patient outcome data collected at week 5 and week 11|||units on a scale||Standard Error|Least Squares Mean
1368691|NCT01582945|Primary|Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)|Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.|Weekly for total duration of 4 months|The subjects received a total of 6 infusions, twice a week for three weeks.|||participants who met response criteria|||Number
1368692|NCT01582880|Secondary|Systemic Safety|Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).|measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52|52 year old white male|||Incidences|||Number
1368693|NCT01582880|Secondary|Ocular Safety|Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)|measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52|52 year old white male|||Incidences|||Number
1368694|NCT01582880|Secondary|Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers|Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit.|post op week 52|52 year old white male|||occurrences|||Number
1368695|NCT01582880|Primary|Changes in Corneal Thickness at 2 Millimeter|The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.|measured at week 4, 6, 26, 32, 52|52 year old white male patient|||micrometer|||Number
1368696|NCT01582880|Primary|Changes in Corneal Thickness at 1 Millimeter|The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.|measured at week 4, 6, 26, 32, 52|52 year old white male patient|||micrometer|||Number
1368697|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research].|Month 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
1368698|NCT01582854|Secondary|Beck Depression Inventory, Version II (BDI-II) at Months 3, 6 and 12|"The BDI-II is a 21-question multiple-choice self-report inventory for measuring the severity of depression. is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Each answer is scored on a scale 0 (best) to 3 (worst). Total scores range from 0 to 63 with higher scores indicating more severe depression.~BDI II scale:~0-13 minimal depression~14-19 mild depression~20-28 moderate depression~29-63 severe depression"|Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Deviation|Mean
1368699|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12|The EuroQoL included a visual analogue scale where the subject marks how they feel at that moment on a scale from 0 (the worst health that can be imagined) to 100 (the best health that can be imagined).|Months 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Deviation|Mean
1368700|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 12|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
1368710|NCT01582789|Primary|Comfortable Wearing Time - First Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up|||hours||Standard Deviation|Mean
1368701|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 6|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
1368702|NCT01582854|Secondary|Barthel Index at Months 3 and 6|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include: feeding, transfers (bed to chair and back), grooming, toilet use, bathing, mobility (walking on level surface), going up and down stairs, dressing, continence of bowels and bladder. Each performance item is rated, with a given number of points assigned to each level or ranking. Individual scores are summed for a total possible scores ranging from 0 (worst) to 100 (best) with higher scores indicating more independent daily living.|Months 3 and 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Full Range|Median
1368703|NCT01582854|Secondary|Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12|The NIHSS is a tool to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) to 4 (some level of impairment). The individual scores from each item are summed in order to calculate total possible NIHSS score from 0 (best) to 42 (worst). A negative change from Baseline indicates improvement. ANCOVA model was used for analyses that included treatment and pooled centre as factors and Baseline NIHSS score as a covariate.|Baseline and End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
1368704|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research]. The proportion of participants with dementia was compared between treatments using a Fisher’s exact test.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
1368705|NCT01582854|Secondary|Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months|Responder was defined as an improvement of 4 or more from baseline on the ADAS-cog+ scale using observed data. The proportion of responders was compared between treatments using a chi-square test.|Baseline and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of responders|||Number
1368706|NCT01582854|Secondary|Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12|"The MoCA is a rapid screening test to assess mild cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal. A positive change from Baseline (BL) indicates improvement.~ANCOVA model was used for analyses that included treatment and pooled centres as factors, plus years of education and baseline MoCA score as covariates."|Baseline, End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
1368707|NCT01582854|Secondary|Change From Baseline in ADAS-cog+ at Month 3 and Month 12|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.~ANCOVA model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Months 3 and 12|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score.|||score on a scale||Standard Error|Least Squares Mean
1368708|NCT01582854|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.~Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Month 6|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score and missing total scores (where all item scores missing) imputed by last observation carried forward.|||score on a scale||Standard Error|Least Squares Mean
1368709|NCT01582789|Primary|Comfortable Wearing Time - Second Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up|||hours||Standard Deviation|Mean
1368711|NCT01582789|Primary|Comfort - Second Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|1 subject withdrew from study.|||units on a scale||Standard Deviation|Mean
1368712|NCT01582789|Primary|Comfort - First Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|one drop out at first 2 week follow up|||units on a scale||Standard Deviation|Mean
1368713|NCT01582789|Primary|Comfort - Second Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up|||units on a scale||Standard Deviation|Mean
1368714|NCT01582789|Primary|Comfort - First Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up|||units on a scale||Standard Deviation|Mean
1368715|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|Day 10 after surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||participants|||Number
1368716|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||participants|||Number
1368717|NCT01582490|Secondary|Incidence of Opioid-Related Adverse Events|The incidence of adverse events that were assessed as opioid-related|Through 10 Days Post Surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||participants|||Number
1368718|NCT01582490|Secondary|Time to Hospital Discharge Being Written|The time (hours) to the hospital discharge being written for subjects in each group,|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||hours||Standard Deviation|Mean
1368719|NCT01582490|Secondary|Pain Intensity Assessment at the Time of Hospital Discharge|Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||units on a scale||Standard Deviation|Mean
1368720|NCT01582490|Secondary|Pain Intensity Assessment Upon Waking in the PACU|Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.|Upon waking in the PACO post surgery|There were 9 subjects in the Infiltration - EXPAREL efficacy analysis set and 8 subjects in the Instillation - EXPAREL efficacy analysis set.|||units on a scale||Standard Deviation|Mean
1368721|NCT01582490|Secondary|Total Postsurgical Opioid Consumption in the Surgical Center|Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.|10 days|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||mg||Standard Deviation|Mean
1368722|NCT01582490|Primary|Duration of Analgesia|The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.|10 days|Of the 8 subjects in the Infiltration - EXPAREL group (efficacy analysis set), 5 were censored, leaving 3 subjects who were administered an opioid. Of the 9 subjects in the Instillation - EXPAREL group (efficacy analysis set), 7 were censored, leaving 2 subjects who were administered an opioid.|||hours|||Number
1368723|NCT01582477|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control|Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)|24 hours, 72 hours, and day 10|72 hour reported subject satisfaction at|||units on a scale||Standard Deviation|Mean
1368724|NCT01582477|Secondary|Incidence of Prespecified Opioid-related Adverse Events|Number of subjects|Until hospital discharge order was written, anticipated at 24 hours.||||Number of subjects|||Number
1368725|NCT01582477|Secondary|Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.|Number of pills|48, 72, 96 hours, and 10 days|96 hour measurement given|||Number of tablets||Standard Deviation|Mean
1368726|NCT01582477|Secondary|Physician/Healthcare Professional Assessed Postsurgical Pain|11-point NRS (0-10, 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24 hours after TAP|24 hour NRS is reported|||units on a scale||Standard Deviation|Mean
1368727|NCT01582477|Secondary|Subject Reported Postsurgical Pain|11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP|Data shown are from the 72-hour time point|||units on a scale||Standard Deviation|Mean
1368728|NCT01582477|Primary|The Duration of Abdominal Analgesia From Infiltration Into the TAP||First postsurgical administration of an opioid|Per protocol|||hours||Inter-Quartile Range|Median
1368729|NCT01582451|Secondary|Number of Participants With Change in Anti-LY2605541 Antibodies|The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.|Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.|||participants|||Number
1368730|NCT01582451|Secondary|Change From Baseline in Lipid Profile|Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1368731|NCT01582451|Secondary|Change From Baseline in Body Weight|LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
1368732|NCT01582451|Secondary|Adult Low Blood Sugar Survey (LBSS) Score|LBSS (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1368733|NCT01582451|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1368734|NCT01582451|Secondary|European Quality of Life - 5 Dimension (EuroQol-5D) Score|The EuroQol-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use), and baseline EuroQol-5D score.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EuroQol-5D data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1368735|NCT01582451|Secondary|Number of Insulin Dose Adjustments to Steady-state|The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use).|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data at both baseline and post-baseline.|||number of dose adjustments||Standard Error|Least Squares Mean
1368736|NCT01582451|Secondary|Insulin Dose Per Kilogram of Body Weight|Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
1368737|NCT01582451|Secondary|HbA1c|LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1368738|NCT01582451|Secondary|6-point Self-monitored Blood Glucose (SMBG)|SMBG measurements were taken at 6 time points (pre-morning meal [fasting], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal [fasting] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1368769|NCT01582139|Secondary|Average Glucose Drop|Average glucose drops at specific time points after the onset of exercise; defined as the difference between plasma glucose at onset of exercise and the glucose values reached at 40 and 60 min post onset of exercise.|26 hours (2x admissions)|The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented.|||mg/dL||Standard Deviation|Mean
1368739|NCT01582451|Secondary|Intra-participant Variability in Fasting Blood Glucose (FBG)|FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1368740|NCT01582451|Secondary|Fasting Blood Glucose (FBG) (by Self Monitoring)|LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1368741|NCT01582451|Secondary|Fasting Serum Glucose (FSG) (by Laboratory)|LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1368742|NCT01582451|Secondary|Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with by applying the LOCF method to the post-baseline data.|||percentage of participants|||Number
1368743|NCT01582451|Secondary|Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with by applying the last observation carried forward (LOCF) method to the post-baseline data.|||percentage of participants|||Number
1368744|NCT01582451|Secondary|Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
1368745|NCT01582451|Secondary|Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||events/participant/30 days||Standard Error|Least Squares Mean
1368746|NCT01582451|Secondary|Change From Baseline to 52 Weeks in HbA1c|LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|Baseline, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1368747|NCT01582451|Primary|Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant’s average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1368748|NCT01582308|Secondary|Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax)|Measurement of the time to the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.|||hr||Full Range|Median
1368749|NCT01582308|Secondary|Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax)|Measurement of the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.|||nM||Geometric Coefficient of Variation|Geometric Mean
1368797|NCT01581710|Secondary|Relative Change (%) of FEV1 After the Bronchodilator|Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100|up to 2 weeks||||% (relative change)||Standard Deviation|Mean
1368750|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID|AUC 0-12hr is the area under the plasma drug concentration-time curve calculated for the 12 hour interval after the Day 5 morning dose for the vildagliptin 50 mg BID dose only.|Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5|All participants who had at least at least one measurement. This outcome measure is for the vildagliptin 50 mg BID dose only; therefore, results are only presented for vildagliptin 50 mg BID dose.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
1368751|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr)|AUC 0-24hr is the area under the plasma drug concentration-time curve calculated for the 24 hour interval after the Day 5 morning dose.|Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5|All participants who had at least at least one measurement.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
1368752|NCT01582308|Primary|Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough|Percent inhibition of DPP-4 activity at 24 hours after the Day 5 morning dose (i.e., at trough) was determined by analysis of blood samples collected from the study participants.|24 hours following the final morning dose on Day 5|All participants who had at least at least one measurement.|||Percent inhibition||95% Confidence Interval|Least Squares Mean
1368753|NCT01582282|Primary|Triglyceride Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat|||mg/dL||Standard Error|Mean
1368754|NCT01582282|Primary|Total Cholesterol Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat|||mg/dL||Standard Error|Mean
1368755|NCT01582282|Primary|Change From Baseline in Fasting LDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|The LDL cholesterol values for two subjects at week 12 were unreportable.|||mg/dL||Standard Error|Mean
1368756|NCT01582282|Primary|Change From Baseline in Fasting HDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat|||mg/dL||Standard Error|Mean
1368757|NCT01582282|Primary|Change From Baseline in Fasting HbA1c|Change is defined as Post-Baseline minus Baseline|12 weeks||||percentage of total hemoglobin||Standard Error|Mean
1368758|NCT01582282|Primary|Change From Baseline in Fasting Glucose|Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value|12 weeks|Intent-to-Treat|||mg/dL||Standard Error|Mean
1368759|NCT01582243|Secondary|The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment|Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.|week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||percentage of participants|||Number
1368760|NCT01582243|Secondary|Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week|Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.|Baseline, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||mg/dL||Standard Deviation|Mean
1368761|NCT01582243|Secondary|Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24|PPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||mg/dL||Standard Deviation|Mean
1368762|NCT01582243|Secondary|Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24|FPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||mg/dL||Standard Deviation|Mean
1368763|NCT01582243|Secondary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||percentage||Standard Deviation|Mean
1368764|NCT01582243|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||percentage||Standard Deviation|Mean
1368765|NCT01582178|Primary|Cecal Intubation Time|= time between introduction of the colonoscope into the anus and reaching the cecum.|1-30||||minute||Standard Deviation|Mean
1368766|NCT01582178|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months|||||||
1368767|NCT01582178|Primary|Cecal Intubation Time||3 months|||||||
1368768|NCT01582139|Secondary|Time in Range|Percent time spent within target (70-180 mg/dL) range.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.|||percentage of time spent in range||Standard Error|Mean
1368798|NCT01581710|Primary|Baseline Lung Function in MMEF|Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator|up to 2 weeks||||L/s||Standard Deviation|Mean
1368770|NCT01582139|Secondary|Low Blood Glucose Index|"A measure of the risk of hypoglycemia. It quantifies the frequency and the extent of low BG readings.~A LBGI < 2.5 is associated with a low-risk of hypoglycemia, LBGI 2.5-5 is associated with a moderate risk of hypoglycemia, and LBGI > 5 is associated with a high-risk of hypoglycemia."|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.|||index score||Standard Error|Mean
1368771|NCT01582139|Primary|Hypoglycemic Events|Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.|||hypoglycemic events|||Number
1368772|NCT01582100|Primary|Incidence of Nausea in Patients With GERD|number of events of nausea with or without vomiting in patients with GERD in 4 weeks|4 weeks|||||||
1368773|NCT01582061|Secondary|Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values|Descriptive summary of the effect of pasireotide on IGF-1|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of ng/ml||Standard Deviation|Mean
1368774|NCT01582061|Secondary|Percent Change From Baseline in Growth Hormone (GH) Values|Descriptive summary of the effect of pasireotide on GH.|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of µg/L||Standard Deviation|Mean
1368775|NCT01582061|Secondary|Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Hirsutism|Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value – BL value)/ BL value)*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in scores||Standard Deviation|Mean
1368776|NCT01582061|Secondary|Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Waist Circumference|Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of centimeters||Standard Deviation|Mean
1368777|NCT01582061|Secondary|Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Muscle Strength|Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in scores||Standard Deviation|Mean
1368778|NCT01582061|Secondary|Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Weight|Clinically relevant threshold (at any time point) was reduction of ≥ 5%|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in kg||Standard Deviation|Mean
1368779|NCT01582061|Secondary|Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Body Mass Index (BMI)|Percent change in patients reducing by at least one class level. Class levels: <25.0, 25.0 to <30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value – BL value)/ BL value)*100|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in kg/m2||Standard Deviation|Mean
1368780|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature|degrees celius|Baseline week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in celius||Standard Deviation|Mean
1368781|NCT01582061|Secondary|Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Pulse|Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value – BL value)/ BL value)*100|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in bpm||Standard Deviation|Mean
1368782|NCT01582061|Secondary|Percent Change in Cushing’s Disease Clinical Signs and Symptoms - Blood Pressure (BP)|Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of mmhg||Standard Deviation|Mean
1368783|NCT01582061|Secondary|Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores|"A 12-item Cushing’s syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient~• Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with ‘Sometimes’ or ‘Somewhat’, X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, ‘change from baseline in WPAI-GH scores’ are not included."|Baseline, week 12, 24 and 48|Only patients who completed at least 9 questions on questionnaire were included for that visit.|||percent change in score||Standard Deviation|Mean
1368799|NCT01581710|Primary|Baseline Lung Function of FEV1/FVC Before the Bronchodilator|baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator|up to 2 weeks||||none (ratio)||Standard Deviation|Mean
1368800|NCT01581710|Primary|Baseline Lung Function of FEV1 Before the Bronchodilator|baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator|up to 2 weeks||||L/s||Standard Deviation|Mean
1368801|NCT01581710|Primary|Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)|Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
1368784|NCT01582061|Secondary|Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline|The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12–week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory’s own reference range. All samples, including screening samples, were analyzed by a central laboratory.|Baseline, week 12, 24 and 48|LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method|||percentage of participants||95% Confidence Interval|Number
1368785|NCT01582061|Secondary|Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)|The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12–week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory’s own reference range. All samples, including screening samples, were analyzed by a central laboratory.|Baseline, week 12, 24 and 48|LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method|||percentage of participants||95% Confidence Interval|Number
1368786|NCT01582061|Primary|Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)|Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.|Baseline up to approximately 256 weeks|Three additional arms were created to display subset of subjects with specific criteria.|||percentage of participants|||Number
1368787|NCT01582009|Secondary|6-month Overall Survival Rate|6-month overall survival rate|The time from registration up to 3 years|All treated and eligible patients. Assessed using Kaplan Meier and Proportional Hazards.|||percentage of participants||95% Confidence Interval|Number
1368788|NCT01582009|Secondary|Median Progression Free Survival|Median progression free survival. Assessed using Kaplan Meier and Proportional Hazards.|The time from registration up to 3 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1368789|NCT01582009|Secondary|Number of Participants With an Adverse Event.|Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.|The time from registration up to 3 years|All treated and eligible patients|||Participants|||Count of Participants
1368790|NCT01582009|Primary|Number of Participants With Clinical Response|Number of participants with clinical response. Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors ver 1.0 Committee [JNCI 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST ver. 1.0 criteria.|The time from registration up to 3 years|All treated and eligible patients|||Participants|||Count of Participants
1368791|NCT01582009|Primary|Progression-free Survival (PFS)|6 month PFS survival rate. Calculated as the total number of failures (deaths or progression) divided by the total follow-up or exposure time of patients on study. Assessed using Kaplan Meier and Proportional Hazards.|The time from registration to documentation of disease progression up to 3 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1368792|NCT01581931|Primary|Maximum Concentration (Cmax) of Metformin|Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1368793|NCT01581931|Primary|Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin|AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1368794|NCT01581931|Secondary|Terminal Half-life t1/2 of Metformin|The terminal half-life of metformin in plasma is denoted by t1/2.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||Hours||Geometric Coefficient of Variation|Geometric Mean
1368795|NCT01581931|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Time from dosing to the maximum concentration of metformin in plasma.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||Hours||Full Range|Median
1368796|NCT01581931|Secondary|Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin|AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1368802|NCT01581710|Primary|Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator|Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
1368805|NCT01581684|Primary|Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests|Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).|From drug administration until end of trial examination, up to 13 days|Treated set|||participants|||Number
1368806|NCT01581684|Primary|Number of Participants With Drug Related AEs|Number of participants with drug related adverse events (AEs)|From drug administration until end of trial examination, up to 13 days|Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment|||participants|||Number
1368807|NCT01581684|Secondary|Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)|Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set|||nmol||Geometric Coefficient of Variation|Geometric Mean
1368808|NCT01581684|Secondary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1368809|NCT01581684|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set|||h||Full Range|Median
1368810|NCT01581684|Secondary|Maximum Measured Concentration (Cmax )|Maximum measured concentration of the analyte (BI 411034) in plasma|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment and who provided at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1368811|NCT01581658|Primary|Maximum Concentration|Maximum concentration of the analyte in plasma|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1368812|NCT01581658|Primary|Area Under the Concentration Time Curve of the Analyte in Plasma|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1368813|NCT01581658|Primary|Change From Baseline in Total Urinary Glucose Excretion (UGE)|change from baseline in total urinary glucose excretion (UGE) to 24 hours|baseline and 24 hours|Treated patients who had complete urine sample (baseline and 24 hours) for analyses.|||mg||95% Confidence Interval|Least Squares Mean
1368814|NCT01581619|Secondary|Breast Cosmesis|"Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.~Excellent: Little or no observable change~Good: Minimal but identifiable changes~Fair: Significant results of radiotherapy noted~Poor: Severe normal tissue sequelae"|End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years|The one participant that withdrew consent before outcomes were met was excluded from the analysis.|||Participants|||Count of Participants
1368815|NCT01581619|Secondary|Distant Control Rates|The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.|2 years|The one participant that withdrew consent before the outcome was met was excluded from the analysis|||Participants|||Count of Participants
1368816|NCT01581619|Secondary|Local Control Rates|The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.|2 years|The one participant that withdrew consent before the outcome was met was excluded from the analysis|||Participants|||Count of Participants
1368817|NCT01581619|Primary|Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks|"The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.~Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.~The development of clinical fat necrosis.~The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.~The data is shown as the number of participants that experienced each of the specific toxicities."|2 years|Analysis does not include the one participant who withdrew consent before outcome was met.|||Participants|||Count of Participants
1368818|NCT01581541|Secondary|Clearance|Clearance was calculated from drug dose and AUC(0-∞).|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||L/h/kg||Standard Deviation|Mean
1368819|NCT01581541|Secondary|Urinary Excretion (%)|Elimination of the drug was investigated by analysis of an aliquot of the total urine collected in 24 h.|Every void post-treatment on day 1 of cycle 1||||percent of dose recovered||Standard Deviation|Mean
1370652|NCT01562327|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||6 months after treatment initiation|The Full Analysis Set (FAS) was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants||95% Confidence Interval|Number
1368820|NCT01581541|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)]|Area Under the Concentration-Time Curve From Time 0 to Infinity was estimated by trapezoidal rule calculations|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||µM*min||Standard Deviation|Mean
1368821|NCT01581541|Secondary|Area Under the Concentration-Time Curve From Time 0 to 24 Hours [AUC(0-24)]|Area Under the Concentration-Time Curve From Time 0 to 24 Hours was estimated by trapezoidal rule calculations|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||µM*min||Standard Deviation|Mean
1368822|NCT01581541|Secondary|Terminal Half-life (T1/2)|The terminal half-life (t1/2) was derived from the plasma concentration vs. time data.|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||hours||Standard Deviation|Mean
1368823|NCT01581541|Secondary|Maximum Observed Plasma Concentration (Cmax)|The maximum concentration (Cmax) was determined by visual inspection of the concentration versus time data.|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||µM||Standard Deviation|Mean
1368824|NCT01581541|Secondary|Number of Days on Treatment||up to 126 days|All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response.|||days||Full Range|Median
1368825|NCT01581541|Secondary|Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)|Number of Participants According to Best Response Per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by computed tomography (CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Baseline and every 6 weeks up to 18 weeks|All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response.|||Participants|||Count of Participants
1368826|NCT01581541|Primary|Maximum Tolerated Dose (MTD) of PU-H71|The MTD is the dose level at which no more than 1 of 6 patients experience DLT during the first cycle of treatment, and the dose below that at which at least 2 (of ≤ 6) patients have DLT as a result of the drug.|Cycle 1 (21 days)||||mg/m^2|||Number
1368827|NCT01581541|Primary|Number of Participants With Adverse Events Possibly, Probably, or Definitely Related to Study Drug|Severity of adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 Mild adverse event (AE), Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, and Grade 5 Death related to AE.|3 years and two months and 11 days||||Participants|||Count of Participants
1368828|NCT01581541|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)|A DLT was defined as an adverse event that occurred during cycle 1, was thought to be related to study drug administration, and met one of the following criteria: grade ≥ 3 non-hematologic toxicities (except diarrhea, nausea, vomiting without maximal supportive therapy; alopecia), grade 4 hematologic toxicities (except lymphopenia), and grade 2 ocular toxicity that did not resolve to ≤ grade 1 within 2 weeks. Occurrence of a DLT resulted in a dose reduction following resolution to grade ≤ 2. No more than 2 dose reductions were allowed per patient on study.|Cycle 1 (21 days)||||Participants|||Count of Participants
1368829|NCT01581437|Secondary|Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation|percentage of all patients who had ablation perfornmed|1 year|all patients participating undergo mapping using the 64 pole basket catheter|||percentage of all patients undergoing ab|||Number
1368830|NCT01581437|Secondary|Single-procedure Freedom From Atrial Fibrillation|percentage of patients without prior ablation|one year|percentage of patients who underwent mapping with 64 pole basket catheter|||percentage of patients with no prior abl|||Number
1368831|NCT01581437|Secondary|Mean Time to Recurrence of Atrial Fibrillation|mean time to recurrence of atrial fibrillation|1 year|patients participating undergo mapping using the 64 pole basket catheter|||days||Full Range|Mean
1368832|NCT01581437|Secondary|Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs|To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.|30 min||||participants|||Number
1368833|NCT01581437|Primary|Average Number of Rotors/Focal Drivers in Diverse Locations||30 minutes||||rotor/focal drivers||Standard Deviation|Mean
1368834|NCT01581437|Primary|Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources|percentage of patients|30 minutes||||percentage of patients|||Number
1368835|NCT01581437|Primary|Time to Ablation of All Sources|total time taken to ablate all sources of rotors/focal sources in driver locations|30 minutes|patients participating undergo mapping using the 64 pole basket catheter|||minutes||Standard Deviation|Mean
1368836|NCT01581437|Primary|Percentage of Drivers in Right Atrial|To determine where atypical areas of drivers might be.|30 min||||percentage of rotor sources|||Number
1368837|NCT01581307|Secondary|Overall Response Rate (ORR)|The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups.|Up to 29 months|All participants evaluable at time of analysis|||Participants|||Count of Participants
1368838|NCT01581307|Secondary|Rate of Progression Free Survival (PFS)|PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis|||Participants|||Count of Participants
1368839|NCT01581307|Primary|Median Overall Survival (OS)|OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis|||months||95% Confidence Interval|Median
1368840|NCT01581281|Secondary|Occurrence of Treatment Emergent Serious Adverse Events|To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events.|24 weeks of the trial||||serious adverse events|||Number
1368841|NCT01581281|Secondary|Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase|To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups.|24 weeks|Tolerability was assessed for all participants included in the primary analysis. Of those randomized, 33 were not included in the primary analysis due to early trial closure.|||Participants|||Count of Participants
1368842|NCT01581281|Secondary|Change in Number of Headache Days|"This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between:~Amitriptyline vs. placebo~Topiramate vs. placebo~Amitriptyline vs. Topiramate"|4 week baseline period and last 4 weeks of the 24-week trial|The analysis population included all participants who had observed end-point data: 101 in the topiramate group, 59 in the placebo group, and104 in the amitriptyline group.|||days||Standard Deviation|Mean
1368843|NCT01581281|Secondary|Change in Absolute Headache Disability Score on PedMIDAS|"The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for:~Amitriptyline vs. Placebo~Topiramate vs. Placebo~Amitriptyline vs Topiramate"|baseline and 24 week endpoint||||units on a scale||Standard Deviation|Mean
1368844|NCT01581281|Primary|Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days|"The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight.~For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups."|4 week baseline period and last 4 weeks of the 24-week trial|The primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period between the participants receiving amitriptyline and participants receiving placebo.|||Participants|||Count of Participants
1368845|NCT01581021|Secondary|Mobilization and Pain Survey|Using a numeric rating scale (0 = no pain and 10 = unbearable pain), patients were asked to estimate their experienced pain while at rest and when mobile by specifying a number on the scale.|24 months post-operative||||units on a scale||Standard Deviation|Mean
1368846|NCT01581021|Primary|Scoliosis Research Society-30 Survey|Participants were administered a validated survey for evaluating patient quality of life and satisfaction with treatment. Total SRS-30 scores (max = 150) and the domains: function (max = 35), pain (max = 30), self-image (max = 45), mental health (max = 25), and satisfaction with management (max = 15) were analyzed on a scale from 1 (worst) to 5 (best). The mean was obtained by dividing maximum possible score by the number of questions answered.|24 months post-operative||||units on a scale||Standard Deviation|Mean
1368847|NCT01581021|Primary|Rotation|The degree to which the spinal column is rotated from its normal position will be assessed.|24 months post-operative||||degree||Standard Deviation|Mean
1368848|NCT01581021|Primary|Main Thoracic Cobb|X-rays measures the degree of curve in the thoracic spine.|24 months post-operative||||Degree||Standard Deviation|Mean
1368849|NCT01581008|Secondary|Adherence to the Study Protocol (CASA Arm Only)|"The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as:~how often is depression addressed with a treatment plan?~how often are care team recommendations placed as orders in the medical record?~how often are orders completed?"|3 months|"A variety of process information was analyzed. Please see Bekelman DB et al, Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial Journal of Palliative Medicine 2014, PMID 14329424 for details."|||%in arm severe target symptoms addressed|||Number
1368850|NCT01581008|Secondary|Participation Rates|The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.|7 months|The total population approached was 72 people. 31 consented to be randomized for a participate rate of 43%. Of these, one was a screen failure, and 17 and 13 were randomized to arm 1 and arm 2 respectively.|||participants|||Number
1368851|NCT01581008|Secondary|Was Depression Addressed?|"The Patient Health Questionnaire-9 (PHQ-9) rates nine DSM-IV criteria of depression on a 0 (not at all) to 3 (nearly every day) scale. Scale range is 0-27, with depression severity scored: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-27 (severe). The suicidal item is thoughts that you would be better off dead, or of hurting yourself in some way?"|3 months|This analysis was only conducted in CASA participants|||participants|||Number
1373756|NCT01523886|Secondary|Normal Functional Level|Numer of days before re-establing normal functional level|from the day of surgery to re-establishing normal functional level - an expected average of 7 days.|||||||
1368852|NCT01581008|Primary|Cohort Retention|Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.|3 months||||participants|||Number
1368853|NCT01580995|Primary|Change in HCV RNA Viral Load|Measure change in HCV RNA viral load in treatment group as compared with placebo|Baseline, 12 weeks|patients who completed 12 weeks of follow up|||log(IU/mL)||Standard Deviation|Mean
1368854|NCT01580904|Secondary|LDL Cholesterol|average LDL cholesterol over 24 weeks|Up to 24 weeks||||mg/dL||Standard Deviation|Mean
1368855|NCT01580904|Secondary|Total Cholesterol|average total cholesterol over 24 weeks|Up to 24 weeks||||mg/dL||Standard Deviation|Mean
1368856|NCT01580904|Primary|Fasting Glycemia|average fasting glycemia over 24 weeks|Up to 24 weeks||||mg/dL||Standard Deviation|Mean
1368857|NCT01580904|Primary|Glycated Hemoglobin|average glycated hemoglobin over 24 weeks|Up to 24 weeks|Data are glycated hemoglobin means of all patients per group.|||percent (%)||Standard Deviation|Mean
1368858|NCT01580618|Secondary|Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion|This measures the number of hospital days for each participant after they were started on their infusion therapy.|30 days||||days||Standard Deviation|Mean
1368859|NCT01580618|Secondary|Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion.||30 days||||percentage of participants|||Number
1368860|NCT01580618|Secondary|Percentage of Patients Who Fail Initial Therapy (TNK or Saline) Who at the Request of the Hospital-based Doctor Are Then Switched to the Other Arm/Group AND Who Then Achieve Satisfactory Drainage (Saline or TNK) Therapy.|Only one patient who was on normal saline arm/group was switched (by request of the referring hospital-based doctor) to TNKase, but did not have complete clearing of their effusion. No patient in the TNKase arm/group was switched to normal saline. Therefore, we have removed the TNKase arm/group from this portion of the analysis since there are no participants in this group to analyze this outcome measure.|3-5 days||||percentage of participants|||Number
1368861|NCT01580618|Primary|Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage|This is the percentage of patients in each arm of the study (Normal saline or TNKase) who suffered a hemorrhagic complication directly associated with instillation of normal saline or TNKase|3-5 days||||percentage of participants|||Number
1368862|NCT01580618|Primary|Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy.||3-5 days||||percentage of participants|||Number
1368863|NCT01580592|Secondary|Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events|This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|day 70||||participants|||Number
1368864|NCT01580592|Primary|Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo|The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.|day 70|female and male|||degree celcius||Standard Deviation|Mean
1368865|NCT01580488|Secondary|Change in Skin Thickness From Baseline to Day 22|Change in skin thickness – echo-poor band measured by ultrasound from baseline to end of treatment|Baseline to Day 22||||millimeters||Standard Deviation|Mean
1368866|NCT01580488|Secondary|Change in Lesion Thickness From Baseline to Day 22|Change in total skin thickness measured by ultrasound from baseline to end of treatment|Baseline to Day 22||||millimeters||Standard Deviation|Mean
1368867|NCT01580488|Secondary|Change in Scaling From Baseline to Day 22|Investigator’s rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
1368868|NCT01580488|Secondary|Change in Infiltration From Baseline to Day 22|Investigator’s rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
1368869|NCT01580488|Secondary|Change in Erythema From Baseline to Day 22|Investigator’s rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
1368870|NCT01580488|Primary|Change in the Total Clinical Score From Baseline to Day 22|Investigator’s rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
1368871|NCT01580423|Primary|Unpleasantness of Breathlessness|"Time-weighted averages of unpleasantness of breathlessness.~Subject rating of unpleasantness of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
1368872|NCT01580423|Secondary|Intensity of Pain|"Time-weighted averages for intensity of pain.~Subject rating of intensity of pain on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity was obtained during immersion of the subject's non-dominant hand in cold water."|Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
1368873|NCT01580423|Primary|Intensity of Breathlessness|"Time-weighted averages of intensity of breathlessness.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
1369304|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||percent of participants||95% Confidence Interval|Number
1368874|NCT01580410|Secondary|Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)|The FACT-G (Functional Assessment of Cancer Therapy – General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-“not at all”, 1- “a little bit”, 2-“somewhat”, 3- “quite a bit” and 4-“very much”. The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL.|Throughout study completion, up to 3 years||||units on a scale||Standard Error|Mean
1368875|NCT01580410|Secondary|The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years||Interval between surgery and death or date of last contact, assessed up to 3 years||||overall survival rate (%)||Standard Error|Mean
1368876|NCT01580410|Secondary|The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years||Time to first progression unless the patient’s resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years||||disease-free survival rate (%)||Standard Error|Mean
1368877|NCT01580410|Primary|The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments|If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.|Within 4 weeks of surgery||||number of patients with toxicities|||Number
1368878|NCT01580306|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events.|drug administration until end-of-study examination (7 to 14 days after drug administration)|treated set|||participants|||Number
1368879|NCT01580306|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 2 weeks|treated set|||participants|||Number
1368880|NCT01580306|Primary|Cmax|maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1368881|NCT01580306|Primary|AUC0-∞|"area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.~In this endpoint, the data of AUC0-∞ show inter-individual variabilities."|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration|Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1368882|NCT01580098|Secondary|Number of Hospitalisations|The number of inpatient stays comparing intervention and control group was conducted.|12 months||||number of inpatient stays||Standard Deviation|Mean
1368883|NCT01580098|Secondary|Presence of Diabetic Complications||12 months|No data about the presence of diabetic complications could be analysed at the end of the study, no data was collected for this secondary outcome.||||||
1368884|NCT01580098|Secondary|Medication Changes|Insulin, Change? -> Yes/No|12 months|No data about medical changes could be analysed at the end of the study, no data were collected.||||||
1368885|NCT01580098|Secondary|Body Weight||12 months|baseline demographic characteristics; No patients of the Nurse-Monitoring Group finished the study, as a consequence no Body weight after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||kilograms||Standard Deviation|Mean
1368886|NCT01580098|Secondary|Blood Lipids||12 months|Not all Participants delivered reliable data; Measurements at the beginning of the trial and after 12 months; No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood lipids after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||mg/dL||Standard Deviation|Mean
1368887|NCT01580098|Secondary|Blood Pressure||12 months|Not all Participants delivered data, reliable data was used. No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood pressure after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||mmHg||Standard Deviation|Mean
1368888|NCT01580098|Primary|HbA1c|HbA1c was taken at the beginning of the study and after 12 months.|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no HbA1c after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||HbA1c [%]||Standard Deviation|Mean
1368889|NCT01580098|Primary|Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status.~Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests."|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no SF36 after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||units on a scale (General health score)||Standard Deviation|Mean
1368890|NCT01580072|Secondary|BODE Index (Carinthia)||12 months|||||||
1368918|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1- 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60)|||Percentage of Participants|||Number
1368891|NCT01580072|Secondary|St. George's Respiratory Questionnaire SGRQ (Carinthia)|"The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.~Scores are calculated for three domains:~Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.~A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos"|12 months||||units on a scale||Standard Deviation|Mean
1368892|NCT01580072|Secondary|COPD Assessment Test CAT (Carinthia)|No data available|12 months|||||||
1368893|NCT01580072|Secondary|All Cause Mortality|deceased patients in respect to participating patients, by obituary column|12 months|||||||
1368894|NCT01580072|Secondary|Number of Consultations of Emergency Doctor||12 months||||consultations ED||Standard Deviation|Mean
1368895|NCT01580072|Secondary|Number of Specialist Visits||12 months||||visits specialists||Standard Deviation|Mean
1368896|NCT01580072|Secondary|Number of Primary Care Visits|Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement.|12 months||||visits GP||Standard Deviation|Mean
1368897|NCT01580072|Secondary|Number of Bed Days for Hospitalised Patients||12 months||||bed days||Standard Deviation|Mean
1368898|NCT01580072|Primary|Number of Inpatient Stays||12 months||||inpatient stays||Standard Deviation|Mean
1368899|NCT01580072|Primary|Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status.|Baseline analyses and analyses after 12 months were conducted. Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported. A high score defines a more favorable health state, items are scored on a 0 to 100 range. Scale scores represent the average for all items in the scale that the respondent answered.|12 months||||units on a scale||Standard Deviation|Mean
1368900|NCT01580020|Secondary|Time to the First Retreatment of Both Treatment Arms|Time to the first retreatment|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
1368901|NCT01580020|Secondary|Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Score on a scale||Standard Deviation|Mean
1368902|NCT01580020|Secondary|Change in SF-36 Summary Scores|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Score on a scale||Standard Deviation|Mean
1368903|NCT01580020|Secondary|Change in Mean Visual Function Questionnaire (VFQ-25)|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, 12 months|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Scores on a scale||Standard Deviation|Mean
1368904|NCT01580020|Secondary|Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12|FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,|Baseline, Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||um||Standard Deviation|Mean
1368919|NCT01579916|Primary|Percentage of Participants Reporting Fever Within 7 Days Post Vaccination|A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza vaccine = 241; placebo = 60).|||Percentage of Participants|||Number
1374078|NCT01520532|Secondary|Acute Safety Events|Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.|30 days|All subjects who underwent an ablation and post-procedure MRI|||events|||Number
1368905|NCT01580020|Secondary|Change in Central Subfield Thickness (CSRT) From Baseline to Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline , Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||um||Standard Deviation|Mean
1368906|NCT01580020|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline|12 month|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Percentage of participants|||Number
1368907|NCT01580020|Secondary|Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement|Baseline, 6 months and 12 months|FAS consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Letters read correctly||Standard Deviation|Mean
1368908|NCT01580020|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants who experienced Adverse events, serious AE and death|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.|||Participants|||Number
1368909|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of Participants|||Number
1368910|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of Participants|||Number
1368911|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
1368912|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
1368913|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
1368914|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
1368915|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
1368916|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
1368917|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
1368920|NCT01579812|Secondary|Overall Survival|Determine the median overall survival time for all patients who complete treatment as well as for patients presenting with stage IIc/ III and stage IV ovarian cancer.|Up to 3 Years|90 patients were enrolled and only 38 patients completed treatment. 25 of the 38 patients had stage IIc/III ovarian cancer. 13 of the 38 patients had stage IV ovarian cancer.|||months||95% Confidence Interval|Median
1368921|NCT01579812|Primary|Recurrence-Free Survival|"Determine the percentage of patients alive without recurrence at 18 months. Investigators will also determine recurrence free survival when patients with persistent disease are excluded.~Definition of progression or recurrence and survival will be defined as increasing clinical, radiological or histological evidence of disease since study entry or two serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN) performed at least one week apart, regardless of CT scan results.~Recurrence-Free Interval will be defined as date from start of chemotherapy to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause."|18 months|90 patients were enrolled, only 38 completed treatment and were analyzed. Patients found to have persistent disease were censored at the time they were found to have progressive disease. 11 patients had persistent disease.|||percentage of patients||95% Confidence Interval|Number
1368922|NCT01579747|Secondary|Number of Redirections|Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.|6 months||||passes||Inter-Quartile Range|Median
1368923|NCT01579747|Primary|Procedural Time|Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique|less than 30 minutes||||seconds||Standard Deviation|Mean
1368924|NCT01579669|Secondary|Change in Patient Healthcare Self-Efficacy|Autistic participants completed a 21-item healthcare self-efficacy scale before and 1 month after use of the toolkit. The scale was created de novo for this study, based on our prior qualitative work. Items addressed aspects related to healthcare navigation (e.g. “How confident are you that you can make an appointment with your healthcare provider when needed?”), successful interactions with providers, (e.g. “How confident are you that you can describe your symptoms or healthcare concerns to your provider?”), and self-management (e.g. “How confident are you that you can take medications the way you are supposed to take them?”). Response options used a 4-point Likert scale with anchors of “0 - Not at all confident” to “3 - Totally confident”. We scored self-efficacy by adding responses from the 21 items, resulting in a possible range of 0 to 63, with higher scores corresponding to higher self-efficacy. Cronbach's alpha was 0.92.|Before and 1 month after use of toolkit|Participants completing pre- and post-intervention survey themselves (not via a supporter), who had complete data on the self-efficacy scales on both surveys.|||units on a scale||Standard Error|Mean
1368925|NCT01579669|Secondary|Change in Patient's Perceived Barriers to Healthcare|Autistic participants were presented with a list of 16 barriers to healthcare and asked which ones keep them from obtaining good care. We compared the total number of barriers endorsed by participants in the pre- and post-intervention surveys. The proxy version of the survey included a few modified items to differentiate between barriers faced by the autistic individuals and those faced by the supporter. Due to differences in the wording, we could not combine results from those who participated directly with those who participated by proxy. Only data from autistic adults who participated directly is shown.|Before and 1 month after use of toolkit|Participants completing the pre and post-test themselves (not via a supporter).|||number of barriers||Standard Error|Mean
1368926|NCT01579669|Secondary|Change in Patient Satisfaction With Healthcare|Patients completed an 8-item instrument assessing satisfaction with their primary healthcare experiences. The scale was previously adapted from the 2007 Health Information National Trends Survey (HINTS). In the pre-intervention survey autistic participants were asked to think about their last visit with their primary care provider. We did not assess patient-provider communication for those who were participating via a proxy as we did not feel that a proxy could adequately rate how satisfied the patient was with communication. Only autistic participants who said they had seen their PCP since using the healthcare toolkit were re-asked these items in the post-intervention survey. Responses used a 5-point Likert scale with anchors of “1 – Strongly Disagree” to “5 – Strongly Agree”. We analyzed items by summing the responses into a composite score (range 8-40; higher scores indicate higher satisfaction). Cronbach's alpha = 0.92.|before and 1 month after use of toolkit|Autistic adults who participated directly (not via a proxy) and who saw their provider in the 1 month between when they participated in the baseline assessment and they completed the post-intervention survey.|||units on a scale||Standard Error|Mean
1368927|NCT01579669|Secondary|Patient Use of Toolkit Components|We collected data on whether or not participants completed the Autism Healthcare Accommodations Tool (AHAT) survey and whether or not they allowed the research team to send a copy of the report to their primary care provider.|1 month after use of toolkit||||percentage of participants|||Number
1368928|NCT01579669|Secondary|Provider Satisfaction|Providers participated in a brief survey to assess satisfaction with the toolkit. Items addressed overall satisfaction and if they would or would not use the tools with other patients.|1-2 months after patient uses toolkit|Participants' primary care providers. Primary care providers were included in the study to assess their impression of the toolkit, but all other outcomes (e.g. change in barriers, self-efficacy, or satisfaction with healthcare) only apply to the autistic participants, not their primary care providers.|||percentage of PCPs|||Number
1368929|NCT01579669|Primary|Patient Satisfaction|Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.|1 month after use of toolkit||||percentage of participants|||Number
1368943|NCT01579565|Primary|Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively|The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours postoperatively|Subjects with scores at time points.|||units on a scale||Standard Deviation|Mean
1375073|NCT01509040|Secondary|Ejection Fraction|This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients|48 hours||||percentage||Inter-Quartile Range|Mean
1368930|NCT01579578|Secondary|The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR. (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)|Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full analysis set|||Participants|||Number
1368931|NCT01579578|Secondary|Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).|Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012||||months|Participants|Inter-Quartile Range|Median
1368932|NCT01579578|Primary|Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone||Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full Analysis Set|||percentage change|Participants|Standard Error|Least Squares Mean
1368933|NCT01579565|Secondary|Systemic Pharmacokinetics (PK) of OMS302|Systemic pharmacokinetics (PK) of phenylephrine (PE) and ketorolac (KE) were performed in a subset of subjects. Descriptive summary statistics for area-under-the-serum-concentration-time curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), and terminal phase half-life (t1/2) were to be generated if measured plasma concentrations were adequate for analysis. Descriptive statistics for pharmacokinetics were not performed as detected concentrations were low and insufficient for analysis.|24 hours|Subset of subjects randomized to OMS302 treatment.|||participants|||Number
1368934|NCT01579565|Secondary|Postoperative Best Corrected Visual Acuity (BVCA) on Day 1|Best Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. The reason for missing scores (e.g., subject could not read enough letters to obtain a score or refraction was not completed) was also summarized. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day postoperatively|Subjects with score at time point.|||Log score||Standard Deviation|Mean
1368935|NCT01579565|Secondary|Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day postoperatively|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1368936|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 1 Day Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.|One day postoperatively|Subjects with scores at time point.|||participants|||Number
1368937|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) – Photophobia 6 Hours Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point.|Six hours postoperatively|Subjects with scores at time point.|||participants|||Number
1368938|NCT01579565|Secondary|Ocular Pain VAS Score on Day 1|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time point.|One day postoperatively|Subjects with score at time point.|||units on a scale||Standard Deviation|Mean
1368939|NCT01579565|Secondary|Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively|The number of subjects who report ocular pain-free status (VAS equal to 0) at all time points during 12 hours postoperatively summarized by treatment arm. Subjects with missing VAS scores during the 12 hours postoperatively were considered as not being pain-free.|12 hours postoperatively|Subjects with scores at time points.|||participants|||Number
1368940|NCT01579565|Secondary|Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively|The number of subjects with moderate -to-severe pain (VAS greater than or equal to 40) at any time point during 12 hours postoperatively summarized by treatment arm.|12 hours postoperatively|Subjects with VAS scores at time points.|||participants|||Number
1368941|NCT01579565|Secondary|Pupil Diameter Less Than 6 mm Anytime During Surgery|The number of subjects with pupil diameter less than 6 mm at any time during surgery summarized by treatment arm.|Intraoperative|Subjects with interpretable video images obtained during ILR procedure.|||participants|||Number
1368942|NCT01579565|Secondary|Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up|The number of subjects with pupil diameter of at least 6 mm at the completion of cortical clean up summarized by treatment arm. The last pupil diameter was used if not available at completion of cortical clean up.|at time of cortical clean-up (i.e., end of surgical procedure)|Subjects with interpretable video images obtained during ILR procedure.|||participants|||Number
1368958|NCT01579318|Other Pre-specified|Immunologic Effects of IL-12 Plasmid Electroporation in Peripheral Blood|"This outcome measure was erroneously entered as secondary but is truly an exploratory endpoint.~Planned analyses were:~Changes in the proportion of circulating regulatory and effector T cells in peripheral blood.~Changes in phenotype of leukocyte subsets and T cell receptor clonal expansion"|2 years|Due to early termination of the study immunologic effects of IL-12 plasmid electroporation in peripheral blood data was not collected and reported.||||||
1368944|NCT01579565|Primary|Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery|The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.|From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.|||mm||Standard Deviation|Mean
1368945|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368946|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368947|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368948|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368949|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368950|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368951|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368952|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
1368953|NCT01579474|Secondary|Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8|Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8|up to 8 weeks|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||percentage of participants|||Number
1368954|NCT01579474|Secondary|Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)|Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||percentage of participants||95% Confidence Interval|Number
1368955|NCT01579474|Secondary|Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)|Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||percentage of participants||95% Confidence Interval|Number
1368956|NCT01579474|Primary|Number of Patients With Investigator Defined Drug-related Adverse Events|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|Up to 52 weeks|Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication.|||participants|||Number
1368957|NCT01579318|Primary|Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Composite Global Score|ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT Composite Global Score. This assessment evaluated skin, lymph node, blood and visceral involvement. The response generated in each category was used to determine the Global ORR: CR=complete disappearance of all clinical evidence of disease or, no involvement of disease at baseline through time of response evaluation (NI); PR=regression of measurable disease as follows: 100% clearance of skin lesions, all other categories do not have CR/NI and no category has progressive disease (PD) -OR- 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease, and if any other category was involved at baseline, at least one has CR/PR and no category has PD.|Every 28 days for the first 24-weeks of treatment|mSWAT Composite Score was not collected and reported due to early termination of the study.||||||
1368959|NCT01579318|Other Pre-specified|Immunologic Effects of IL-12 Plasmid Electroporation in Tissue|"This outcome measure was erroneously entered as secondary but is truly an exploratory endpoint.~Planned analyses were:~Transcriptional analysis of interferon pathway activation, antigen presentation and processing machinery (APM) upregulation, and immune cell infiltration in tissue at baseline and post-treatment.~Changes in the characterization of local tissue effects, proportion and phenotype, of intratumoral leukocyte subsets post-treatment.~Changes in T cell receptor clonal expansion and persistence of initial clones post- treatment.~Changes in FOXP3 methylation and quantification of regulatory T cells post- treatment."|2 years|Due to early termination of the study immunologic effects of IL-12 plasmid electroporation in tissue data was not collected and reported.||||||
1368960|NCT01579318|Secondary|Quality of Life (QoL)|Participants were to complete the following QoL assessments prior to clinical evaluations every 4 weeks: Skindex29, FACT-G (Functional Assessment of Cancer Therapy -General) and VAS-P (Visual Analog for Pruritus) questionnaires.|Every 28 days for up to 340 days|Due to early termination of the study QoL data was not collected and reported.||||||
1368961|NCT01579318|Secondary|Time to Overall Objective Response Assessed by mSWAT Skin Score|Time to overall objective response (CR or PR) is the number of days from the start of therapy to the first documentation of objective response assessed by mSWAT Skin Score: CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.|From start of study treatment until overall objective response (Up to 340 days)|All enrolled participants who achieved an objective response.|||days|||Number
1368962|NCT01579318|Secondary|Duration of Overall Objective Response Assessed by mSWAT Skin Score|Duration of overall objective response (CR or PR) is defined as the number of days from the initial documentation of an objective response to the most current evaluation of that response or to documentation of progression assessed by mSWAT Skin Score: CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.|From first documented response until disease progression (Up to 340 days)|All enrolled participants who achieved an objective response.|||days|||Number
1368963|NCT01579318|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.|From the start of study treatment up to 340 days|All enrolled participants.|||percentage of participants|||Number
1368964|NCT01579318|Primary|Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Score in the Skin|ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT score. The mSWAT defines 3 lesion types and assigns each a weighing factor: patch (no induration or significant elevation)=1; plaque (induration, crusting, ulceration or poikiloderma)=2; tumor (solid or nodular ≥ 1 cm in diameter with evidence of deep infiltration and/or vertical growth)=4. Lesions are assessed by body surface area (BSA) where palm + fingers = approximately 1% BSA in each of 12 areas (head, neck, anterior trunk, arms, forearms, hands, posterior trunk, buttocks, thighs, legs, feet, groin), and the sum of each area of BSA is multiplied by its weighing factor. An overall sum of each subtotal represents the mSWAT score (0=no lesions; 400=lesions covering all areas). CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.|Every 28 days for the first 24-weeks of treatment|All enrolled participants.|||percentage of participants|||Number
1368965|NCT01579305|Primary|Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer’s Assessment|The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).|3 months|Per-protocol population (all subjects who are randomized, received at least 1 study treatment, and have no protocol deviations that affect the primary effectiveness endpoint)|||Percentage of subjects||95% Confidence Interval|Number
1368966|NCT01579214|Secondary|Clinic Return Within 28 Days of Abnormal CD4 Count Result|Number of participants who returned to clinic within 28 days of abnormal CD4 count result|28 days||||Participants|||Count of Participants
1368967|NCT01579214|Primary|Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result|Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result|28 days|These are participants who were Antiretroviral Therapy naive, and so analysis of this measurement is using this subgroup only.|||Participants|||Count of Participants
1368968|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 5|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Participants||Number
1368969|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Participants||Number
1368970|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness.|Baseline, Day 1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Participants||Number
1368971|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject’s Self Assessment (SSA) at Day 1|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 1-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Participants||Number
1368972|NCT01579045|Secondary|Monocular Visual Acuity in Recumbent Position|Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).|up to 60 minutes in recumbent position|Analysis is on those who were enrolled, randomized, and whom completed the study.|||units on a scale (LogMAR)||95% Confidence Interval|Least Squares Mean
1368973|NCT01579045|Primary|Lens Orientation in Recumbent Position|rotation from zero position also described as absolute value of the rotation.|up to 60 minutes in recumbent position|Subjects analyzed were those enrolled, randomized, and whom completed the study.|||degrees||95% Confidence Interval|Least Squares Mean
1368974|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation||5-6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1368975|NCT01579006|Secondary|Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
1368976|NCT01579006|Secondary|Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6|The FACIT Measurement System was a collection of health-related quality of life questionnaires targeted to the management of chronic illness and included questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. The FACIT Fatigue Scale was a 13-item tool that measured an individual’s level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a five-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score of FACIT ranged from 0 to 160. An increase of 4 points in the FACIT-Fatigue score was considered clinically meaningful. Change from Administration 1 was reported for individual administration schedules. TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|Administration 1 (Baseline), 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||Score on a scale||Standard Deviation|Mean
1368977|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain). A decrease of 10 points was considered clinically meaningful.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
1368978|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
1369000|NCT01579006|Secondary|Percentage of Participants With Reasons for Dose Modification|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had dose modifications were reported.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1368979|NCT01579006|Secondary|Change From Baseline in HAQ-DI at Month 6|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from “no difficulty” to “unable to do”, corresponding to scores from 0 to 3. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity. A score of <0.5 represented clinical remission. A participant achieved a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of >=0.22.|Baseline, 6 months|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1368980|NCT01579006|Secondary|Change From Baseline in PGH of Disease Activity at Month 6|"The PGH of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
1368981|NCT01579006|Secondary|Change From Baseline in PhGH at Month 6|"The PhGH was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
1368982|NCT01579006|Secondary|Change From Baseline in ESR at Month 6|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. ESR was measured in mm/hr. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm/hr||Standard Deviation|Mean
1368983|NCT01579006|Secondary|Change From Baseline in CRP at Month 6|The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. The serum concentration of CRP was measured in mg/dL. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
1368984|NCT01579006|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1368985|NCT01579006|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1368986|NCT01579006|Secondary|Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant’s global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1368987|NCT01579006|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of <=10.0 represented low disease activity, a score of <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1369001|NCT01579006|Secondary|Percentage of Participants With Dose Modifications|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||percentage of participants||95% Confidence Interval|Number
1368988|NCT01579006|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of <=11.0 represents low disease activity, a score of <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1368989|NCT01579006|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB >=-0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1368990|NCT01579006|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [mm/hr]), and Patient’s Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1368991|NCT01579006|Secondary|Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6|The number of swollen joints was recorded on the joint assessment form, with no swelling = 0, and swelling =1, for 66 joints, giving a total possible SJC score of 0 to 66.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Swollen Joint Count||Standard Deviation|Mean
1368992|NCT01579006|Secondary|Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6|The number of tender joints was recorded on the joint assessment form, with no tenderness = 0, and tenderness = 1, for 68 joints, giving a total possible TJC score of 0 to 68.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants with valid data to calculate TJC at the end of study (6 months).|||Tender Joint Count||Standard Deviation|Mean
1368993|NCT01579006|Secondary|Percentage of Participants on TCZ Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had TCZ as monotherapy were reported.|Up to 6 months|FAS population. Here, “n”= participants who were evaluable for each category.|||percentage of participants||95% Confidence Interval|Number
1368994|NCT01579006|Secondary|Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician|A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1368995|NCT01579006|Secondary|Time to Restoration of Initial Dosing Regimen||6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
1368996|NCT01579006|Secondary|Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population.|||percentage of participants||95% Confidence Interval|Number
1368997|NCT01579006|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. The mean dosing interval between different TCZ administrations (Adm) by participants within 6 months observational period was presented.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||days||Standard Deviation|Mean
1368998|NCT01579006|Secondary|Mean Number of Dose Modifications at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||dose modification||Standard Deviation|Mean
1368999|NCT01579006|Secondary|Mean Dose at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
1375074|NCT01509040|Secondary|Shock|This will be defined as systolic blood pressure < 65 at the end of any four hour period during the initial 48 hours of enrollment in control and intervention patients.|48 hours||||participants|||Number
1369002|NCT01579006|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined by physician discretion. Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||percentage of participants|||Number
1369003|NCT01579006|Secondary|Duration of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||years||Standard Deviation|Mean
1369004|NCT01579006|Secondary|Percentage of Participants With Type of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). Same participants may be counted in more than one previous biologic RA treatment category.|Up to 6 months|FAS population.|||percentage of participants|||Number
1369005|NCT01579006|Secondary|Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study|"Biological RA treatment exposure was evaluated for all participants. Prior biological RA treatment included participants who were treated with biological RA treatment 8 weeks before being included in the study. Percentage of participants who did not receive any biological RA treatment and percentage of participants who received one or more biologic RA treatments were reported."|Prior to study start (8 weeks)|FAS population.|||percentage of participants|||Number
1369006|NCT01579006|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|Up to 6 months|FAS population.|||percentage of participants||95% Confidence Interval|Number
1369007|NCT01579006|Secondary|Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment included participants, who were treated with DMARDs 8 weeks and according to physician's discretion before being included in the study. DMARDs treatment at baseline included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ. Only those participants who received DMARDs prior to start of study and at Baseline up to 6 months were reported."|Prior to study start (8 weeks) and Baseline up to 6 months|FAS population.|||percentage of participants|||Number
1369008|NCT01579006|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations included fibromyalgia, osteoporosis, sjogren’s syndrome, anemia, rheumatoid nodules, pulmonary fibrosis, vasculitis, peripheral neuropathy or mononeuropathy, scleritis, episcleritis, hypertension, hyperlipidemia, low high-density lipoproteins, diabetes type 1 and type 2, metabolic syndrome, carotid artery disease, transient ischemic attacks, embolic stroke, atherothrombotic stroke, atrial fibrillation, heart failure New York Heart Association (NYHA) Class l/ll, coronary heart disease(angina pectoris/myocardial), aortic aneurism, peripheral arterial occlusive disease, percutaneous coronary interventions, coronary artery bypass, carotid endarterectomy and peripheral arterial bypass.|Baseline|FAS population.|||percentage of participants|||Number
1369009|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1369010|NCT01578993|Primary|Rate of PICC Line Occlusions|The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.|Insertion to Removal / maximum 3 months||||percentage of enrolled subjects|||Number
1369011|NCT01578980|Secondary|Frequency of Unplanned System Resets or Restarts|"Frequency of unplanned system resets or restarts~Secondary endpoints include the estimation of the failure rates of system components, frequency analysis of lost or inaccurate CGM records, and percent time of active CTR. The failure/missing data records will be compared to failure/missing data records from our past in-clinic studies."|42 hours|The three pilot subjects (one for each country) were not included in the analysis.|||events per 24 hours|||Number
1369012|NCT01578980|Primary|Percent Time of Active CTR|The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation for the entire arm.|42 hours|The three pilot subjects (one for each country) were not included in the analysis.|||percentage of time of active CTR|||Number
1369013|NCT01578967|Other Pre-specified|Exploratory Objective Whether the Cytokine Profile Changes After Treatment|To determine whether the cytokine profile changes after treatment, and to correlate serum levels of cytokines with the overall response after ABVD followed by brentuximab vedotin consolidation|12 months|||||||
1369014|NCT01578967|Secondary|Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher|Number of adverse events attributed to Brentuximab Vedotin with a grade 3 or higher. Toxicity assessed via the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.The higher the grade the more severe the adverse event.|12 months|Please note all grade 4 or higher events were experienced by one patient. The patient developed fever and hepatic dysfunction after 1 dose of Brentuximab Vedotin (BV). Patient also developed pancreatitis and eventually died of sepsis.|||Number of events|||Number
1369015|NCT01578967|Secondary|Time to Progression|Defined as the time from ABVD treatment initiation until the time of disease progression or death due to progressive disease.|5 years|||||||
1369016|NCT01578967|Secondary|Progression Free Survival|Defined as the time from ABVD treatment start until disease progression or death from any cause.|5 years|||||||
1369305|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||percent of participants||95% Confidence Interval|Number
1369017|NCT01578967|Secondary|Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response.|Conversion rate to Complete Response after brentuximab vedotin in patients with partial response at the end of ABVD therapy. Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least 2 perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.|12 months|4 subjects had a partial response (PR) (Deauville score of 3)|||Participants|||Count of Participants
1369018|NCT01578967|Secondary|Number of Participant Who Achieved a Complete Response|Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|12 months|One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients|||Participants|||Count of Participants
1369019|NCT01578967|Primary|Percentage of Patients With Positron Emission Tomography (PET) Negative Disease|"Percentage of patients who convert to PET negative disease post consolidation. This is defined by PET with Deauville <=2.~The Deauville 5-point scoring system is a five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG Positron emission tomography:~Score 1: No uptake above the background Score 2: Uptake ≤ mediastinum Score 3: Uptake > mediastinum but ≤ liver Score 4: Uptake moderately increased compared to the liver at any site Score 5: Uptake markedly increased compared to the liver at any site Score X: New areas of uptake unlikely to be related to lymphoma"|12 months|One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients|||Participants|||Count of Participants
1369020|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
1369021|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
1369022|NCT01578850|Secondary|Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2|Participants were asked to answer the question “In general how would you rate your health over the last 2-3 weeks?” by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
1369023|NCT01578850|Secondary|Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1|Participants were asked to answer the question “In general how would you rate your health over the last 2 3 weeks?” by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
1369024|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||minutes||Standard Deviation|Mean
1371017|NCT01557166|Secondary|Change From Baseline in Body Weight (kg)|Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 353 subjects contributed to the statistical analysis.|||kg||Standard Deviation|Mean
1369025|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||minutes||Standard Deviation|Mean
1369026|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 2|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
1369027|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 1|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
1369028|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2|The investigator estimated the subject’s overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an ‘X’.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
1369029|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1|The investigator estimated the subject’s overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an ‘X’.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
1369030|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
1369031|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Units on a scale||Standard Deviation|Mean
1369032|NCT01578850|Secondary|Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR’s definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
1369033|NCT01578850|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR’s definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||percentage of participants|||Number
1369043|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
1369034|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 2|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
1369035|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 1.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
1369036|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization|||Percentage of participants|||Number
1369037|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
1369038|NCT01578850|Secondary|Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
1369039|NCT01578850|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
1369040|NCT01578850|Secondary|Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria|Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
1369041|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
1369042|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
1369044|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1|Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
1369045|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
1369046|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
1369047|NCT01578850|Secondary|Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)|Proportion of participants who remained in Remission (DAS28-ESR <2.6) at Week 52.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
1369048|NCT01578850|Primary|Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.|Proportion of participants who remained in LDA DAS28-ESR <3.2 at Week 52 is presented below.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||percentage of participants|||Number
1369049|NCT01578785|Secondary|Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume|Brain atrophy was defined by the percent brain volume change from baseline to Month 12|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
1369050|NCT01578785|Secondary|The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
1369051|NCT01578785|Secondary|The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
1369052|NCT01578785|Primary|The Annualized Relapse Rate During the Placebo Controlled Period|The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
1369053|NCT01578772|Primary|6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)||||percentage of maximum relative FMD||Inter-Quartile Range|Median
1369054|NCT01578772|Primary|6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)||||mm||Inter-Quartile Range|Median
1369055|NCT01578707|Secondary|Hematological Improvements||2 years|||||||
1369056|NCT01578707|Secondary|OS (Overall Survival)||OS analysis was conducted at the time of the interim PFS analysis, which was about 18 months after the first subject was enrolled.||||months||95% Confidence Interval|Median
1369057|NCT01578707|Primary|PFS (Progression Free Survival)|"The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS).~Progressive disease according to 2008 IWCLL guidelines was defined as:~Group A~Lymphadenopathy, increase ≥50%~Hepatomegaly, increase ≥50%~Splenomegaly, increase ≥50%~Blood lymphocytes, increase ≥ 50% over baseline~Group B~Platelets counts, decrease of ≥ 50% from baseline secondary to CLL~Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL"|Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.||||months||95% Confidence Interval|Median
1369058|NCT01578499|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs and SAEs were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|First dose of study drug through 30 days after last dose of study drug (Up to 395 days)|The Safety population included participants who received at least one dose of study drug.|||participants|||Number
1369306|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months.|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Percent of participants||95% Confidence Interval|Number
1369059|NCT01578499|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score|FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. A negative change (reduction) from Baseline indicates improvement.|Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 22.9 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||score on a scale||Standard Deviation|Mean
1369060|NCT01578499|Secondary|Change From Baseline in the Skindex-29 Questionnaire Total Score|Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.|Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 22.9 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||score on a scale||Standard Deviation|Mean
1369061|NCT01578499|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin|Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.|Baseline up to End of Treatment (Week 52)|The Safety population included participants who received at least one dose of study drug.|||participants|||Number
1369062|NCT01578499|Secondary|Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin||Day 1 pre-dose of Cycles 2 and 4|The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ng/mL||Standard Deviation|Mean
1369063|NCT01578499|Secondary|Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin||Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3|The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ng/mL||Standard Deviation|Mean
1369064|NCT01578499|Secondary|Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin||Day 1 pre-dose of Cycles 2 and 4|The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ug/mL||Standard Deviation|Mean
1369065|NCT01578499|Secondary|Cmax: Maximum Observed Concentration for Brentuximab Vedotin||Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3|The pharmacokinetic (PK) population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ug/mL||Standard Deviation|Mean
1369066|NCT01578499|Secondary|Event-Free Survival (EFS)|EFS was assessed by the IRF and is defined as the time from randomization until any cause of treatment failure: disease progression, discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|From randomization until disease progression, death or data cutoff (Median follow-up 26.1 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||months||Full Range|Median
1369067|NCT01578499|Secondary|DOR of Skin Response|Duration of skin response (CR and PR) was assessed by the investigator and is defined as the time between the first skin response to progressive disease in skin. Per mSWAT, CR is defined as 100% clearance of skin lesions. PR is defined as 50%-99% clearance of skin disease from Baseline; No new tumors in participants without tumors at Baseline -MF; No new tumors-primary cutaneous anaplastic large cell lymphoma (pcALCL).Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, or new tumors in patients without tumors at baseline (MF).|Until disease progression, death or data cutoff (Median follow-up 22.9 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Skin responders in ITT population were analyzed in this outcome measure.|||months||95% Confidence Interval|Median
1369068|NCT01578499|Secondary|Duration of Response (DOR)|Duration of response was assessed by the IRF in participants with confirmed response [CR or Partial Response (PR)] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|Until disease progression, death or data cutoff (Median follow-up 22.9 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Responders in ITT population were analyzed in this outcome measure.|||months||95% Confidence Interval|Median
1369069|NCT01578499|Secondary|Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire|Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, from 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.|Baseline up to End of Treatment (Week 52)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here number of participants analyzed are participants evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
1369070|NCT01578499|Secondary|Progression-Free Survival (PFS)|PFS was assessed by the IRF and is defined as the time from randomization until disease progression or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|Until disease progression, death or data cutoff (Median PFS follow-up of 17.5 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||months||95% Confidence Interval|Median
1369071|NCT01578499|Secondary|Percentage of Participants Achieving a CR|Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|Each Cycle until disease progression, death or data cutoff (Median overall follow-up 22.9 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
1369072|NCT01578499|Primary|Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)|ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).|Each Cycle until disease progression, death or data cutoff (Median overall follow-up 22.9 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
1369073|NCT01578486|Secondary|IL-6|IL-6 (interleukin 6) is a marker used to measure inflammation.|Baseline, week 12||||pg/mL||Standard Deviation|Mean
1369074|NCT01578486|Secondary|TNF-alpha|Tumor necrosis-alpha factor will be measured to assess inflammation levels.|Baseline,12 weeks||||pg/ml||Standard Deviation|Mean
1369075|NCT01578486|Secondary|Hs-CRP|High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.|Baseline, 12 weeks||||mg/L||Standard Error|Mean
1369076|NCT01578486|Primary|PANSS- Negative Score|Subscale of Positive and Negative Syndrome Scale that specifically measures negative symptoms. The scores range from 7-49, with higher scores representing a worse outcome.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
1369077|NCT01578486|Primary|PANSS Positive Score|Subscale of Positive and Negative Syndrome Scale that specifically measures positive symptoms. The scores range from 7-49, with higher scores representing a worse outcome.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
1369078|NCT01578486|Primary|MATRICS Composite Score|Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment. The MATRICS assessment includes a battery of tests, and the composite t-score measures cognition across 7 domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. A higher score indicates better cognition.|Baseline, 12 weeks||||t-score||Standard Deviation|Mean
1369079|NCT01578486|Primary|SANS Total Score|Negative symptoms of schizophrenia will be measured by total score on the Scale for Assessment of Negative Symptoms (SANS; score range 0-100). Higher scores correspond with worse outcomes.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
1369080|NCT01578486|Primary|PANSS Total Score|Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210). Higher scores correspond with worse outcomes.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1369081|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||score on scale||Standard Deviation|Mean
1369082|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 6|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||score on scale||Standard Deviation|Mean
1369083|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 1|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||score on scale||Standard Deviation|Mean
1369084|NCT01578330|Primary|Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|Baseline and month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||Scores on a scale||Standard Deviation|Mean
1369085|NCT01578239|Other Pre-specified|Exploratory Objectives|"To explore the correlation of toxicity outcomes and administered radioactivity corrected for body weight and body surface area;~To explore the correlation of clinical efficacy outcomes with the levels of the biomarkers Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine;~To evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients;~To explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake score;~To explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase (AP):~To evaluate the Duration of Response (DoR) in the two study arms;~To evaluate the Time to Second Progression (PFS2) in the two study arms"|Study Treatment Phase|||||||
1369086|NCT01578239|Secondary|Long-term Safety and Efficacy Assessment|"Any progressive patient ceases treatment/assessment and proceeds to long-term follow-up assessment.~Any non-progressive patients continues treatment/assessments until the PFS Primary End-Point, then:~Patients who have 76week or more treatment/assessment stop treatment but continue the long-term follow-up assessments for 5 years overall from the date of randomization of the last randomized.~Remaining randomized patients continue in the fixed 76-week treatment/assessment phase unless progression occurs, then proceed to the long-term follow-up assessment phase for 5 years overall from the date of randomization of the last randomized patient.~During the long-term follow-up assessment phase, toxicities suspected in relation with the study drug (including haematology, biochemistry, urine analyses), anti-tumour treatment administered after progression/discontinuation, disease status based on local CT/MRI assessment, and OS data will be collected every 6 months."|Every 6 months for a period of up to 5 years after the end of the study|||||||
1369087|NCT01578239|Secondary|Safety Assessments (Adverse Events, Laboratory Parameters, Cancer Related Symptoms, Physical Examination, Vital Signs, Karnofsky Performance Status, ECG)|"The following parameters will be monitored:~Changes from Baseline in Hematology (WBC, platelets, haemoglobin, MCV), Blood chemistry (BUN, serum creatinine and creatinine clearance, uric acid, albumin, total bilirubin, AP, aspartate aminotransferase [AST/ASAT], alanine aminotransferase [ALT/ALAT], gamma-glutamyl transferase [γ-GT], [Na], [K], lactic dehydrogenase [LDH], glycosylated hemoglobin/hemoglobin A1c [glycoHb], free thyroxine [fT4]) and Urinalysis (RBC/hpf, WBC/hpf, casts/lpf, protein, 5-HIAA),~Cancer related symptoms,~Physical Examination, including heart rate, blood pressure and weight,~Karnofsky Performance Status,~ECG intervals.~All AEs and SAEs reported (spontaneously or not) by the patient will be collected during the study."|Data for this outcome measure are posted in the Adverse Events section below. Adverse Events table includes all treatment emergent adverse events collected from date of first enrollment (10 Jul 2012) to 30 June 2016.|||||||
1369088|NCT01578239|Primary|Progression Free Survival (PFS)|"Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~CT/MRI tumour assessment in both arms are performed every 12±1 weeks from the first treatment date."|after 74 centrally confirmed cases disease progression or death|Full analysis data set|||months||95% Confidence Interval|Median
1369089|NCT01578187|Primary|Percentage of Participants Performing Critical/Non-critical Errors|"Study staff will record the number of errors according to the following:~Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence~Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event."|1-2 hours|Subjects who were not self-excluders in the label comprehension phase and consented to continue to the usability phase (product use).|||percentage of participants with errors|||Number
1369090|NCT01578187|Primary|Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders)|"Label comprehension will be based on responses to a questionnaire. Questions will be based on a tiered system by level of importance in responding correctly according to the following:~Questions regarding safe use of the system.~Questions regarding correct use of the system(not related to safety).~In order to demonstrate how well the label instruction, as a whole, was understood by all subjects, the proportion of subjects who correctly understood the label as a whole was calculated by classifying each subject as either a “responder or non-responder” based on the following criteria regarding all questions:~A subject was considered a responder if he/she correctly answered 11/12 questions related to safety AND 5/6 low category questions not related to safety.~The study was considered a success if the response rate (i.e., the proportion of subjects correctly understanding the label based on the responder criteria) was at least 90%."|1 hour|Sample size was discussed with the FDA during a pre-IDE teleconference|||percentage of participants|||Number
1369091|NCT01578044|Primary|Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban|The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.|3 and 6 months||||days|||Number
1369092|NCT01578031|Secondary|Change From Baseline in Oxidative Stress|Overnight urinary excretion of 8-isoprostane.|4 months|||||||
1369093|NCT01578031|Secondary|Change From Baseline in Circulating Inflammatory Biomarkers|Circulating IL-6, CRP, and other circulating inflammatory biomarkers.|4 months|||||||
1369094|NCT01578031|Secondary|Change From Baseline in Sympathetic Nervous System Activity|24-hour urine collection for catecholamine levels.|4 months|||||||
1369095|NCT01578031|Secondary|Change From Baseline in Psychomotor Vigilance Task|Reaction time test.|4 months|||||||
1369096|NCT01578031|Primary|Change From Baseline in Mean Arterial Blood Pressure|Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment|4 months||||mm Hg||Inter-Quartile Range|Mean
1369097|NCT01577966|Primary|Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine|To determine the ability of sulfasalazine to alter glioma glutamate levels. These levels will be measured by Magnetic Resonance Spectroscopy (MRS). The percent change is noted per subject. The measure is a % decrease of glioma glutamate levels|up to 2 years post baseline||||percentage of change|||Number
1369098|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE|Area under the plasma drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameter AUC0-21 days.|||day*ng/mL||Full Range|Geometric Mean
1369099|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246|Area under the drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.|||day*μg/mL||Full Range|Geometric Mean
1369100|NCT01577758|Primary|Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.|||ng/mL||Full Range|Geometric Mean
1369101|NCT01577758|Primary|Cmax: Maximum Observed Serum Concentration for MLN0264|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.|||μg/mL||Full Range|Geometric Mean
1369102|NCT01577758|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood was collected and sent to a laboratory to determine the immunogenicity, whether binding antibodies to MLN0264 were present (ATA development).|Day 1 of every 21 days cycle and at End of study (EOS) approximately 9 months||||participants|||Number
1369103|NCT01577758|Secondary|Best Overall Response|"The percentage of participants in each best overall response category, was determined using the Modified Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response: Disappearance of all target lesions and all non-target lesions and normalization of tumor marker level.~Partial Response: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the start or the appearance of one or more new lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits."|At the completion of every second cycle up to 12 cycles (approximately 9 months). Each cycle is a 21 days cycle|Response Evaluable Population is defined as patients with measureable disease who receive any amount of MLN0264 and have at least 1 post-Baseline response assessment.|||percentage of participants|||Number
1369104|NCT01577758|Primary|Maximum Tolerated Dose (MTD) of MLN0264|MTD of MLN0264 was determined. Decisions regarding dose escalation were made based on any DLT that occurred during the first cycle of treatment.|Every 3 weeks until MTD is established, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||mg/kg|||Number
1369115|NCT01577745|Secondary|Half-life (t1/2) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.|||Days||Standard Deviation|Mean
1372661|NCT01536405|Secondary|Percentage of Participants With Measles-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1369105|NCT01577758|Primary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.~A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|Safety Analysis Set included all participants who received at least one dose of study drug.|||participants|||Number
1369106|NCT01577758|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy.~Grade 4 neutropenia (Absolute Neutrophil Count < 500 cells/mm^3).~Grade 3 or greater neutropenia with fever and/or infection.~Grade 4 thrombocytopenia (platelets < 25,000/mm^3).~Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time.~Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis.~Grade 3 or greater diarrhea that occurs despite supportive care.~Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia.~Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery.~Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||participants|||Number
1369107|NCT01577745|Secondary|Overall Survival|Overall survival defined as the time from the first dose of MEDI0639 until death due to any cause. OS (months) = (Date of death or censoring – Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Months||95% Confidence Interval|Median
1369108|NCT01577745|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the first dose of MEDI0639 until the first documentation of disease progression or death due to any cause, whichever occurs first. PFS (months) = (Date of PD/death or censoring – Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Months||95% Confidence Interval|Median
1369109|NCT01577745|Secondary|Duration of Response (DR)|DR defined as time from start of first documented objective response [confirmed Complete Response (CR) or confirmed Partial Response (PR)] to first documented disease progression or death due to any cause, whichever occurs first. DR calculated as (months) = (Date of PD/death or censoring – Date of first disease response + 1)/ (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.|||Months||95% Confidence Interval|Median
1369110|NCT01577745|Secondary|Time to Response|Time to response (TTR) defined as the time from the first dose of MEDI0639 until the first documentation of a subsequently confirmed objective response. Only participants who have achieved objective response (confirmed CR or confirmed PR) was evaluated for TTR. TTR (months) = (Date of first disease response – Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.|||Months||95% Confidence Interval|Median
1369111|NCT01577745|Secondary|Percentage of Participants With Disease Control|Disease control rate (DCR) defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or SD.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Percentage of Participants||95% Confidence Interval|Number
1369112|NCT01577745|Secondary|Percentage of Participants With Objective Response|Objective response rate (ORR) defined as the percentage of participants with a BOR of confirmed CR or confirmed PR.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.|||Percentage of Participants||95% Confidence Interval|Number
1369113|NCT01577745|Secondary|Percentage of Participants With Best Overall Response|Percentage (%) of participants who were responders with BOR documented as confirmed CR, PR, stable disease (SD), progressive disease (PD) and non-evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. PR: At least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Percentage of Participants|||Number
1369114|NCT01577745|Secondary|Number of Participants Positive With Antidrug Antibodies (ADA) for MEDI0639|Blood samples were measured for the presence of ADA for MEDI0639 using a validated bridging immunoassay. Only the number of participants positive for anti-MEDI-575 antibodies at any visit were presented.|On Day 1 of Cycles 1, 2, 3, and every other cycle thereafter, end of treatment, 30 days, and 3 and 6 months after the last dose of MEDI0639. Maximum time frame across participants was 14 months.|All participants who received any treatment with MEDI0639.|||Participants|||Number
1369116|NCT01577745|Secondary|Clearance (CL) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639. Clearance was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.|||Liter per day (L/d)||Standard Deviation|Mean
1369117|NCT01577745|Secondary|Maximum Observed Concentration (Cmax) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1369118|NCT01577745|Secondary|Area Under the Concentration‑Time Curve From Time 0 to Infinity (AUCinf) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom Pharmacokinetic (PK) blood samples were collected and evaluated.|||microgram*day per milliliter (mcg*d/mL)||Standard Deviation|Mean
1369119|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Echocardiogram Evaluations|Echocardiogram parameters included left ventricular ejection fraction (LVEF) and pulmonary arterial pressure (PAP). The TEAEs related to echocardiogram evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
1369120|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (ECG) Evaluations|ECG parameters included QT interval and corrected QT (QTc) interval. Electrocardiogram (ECG) parameters were assessed at baseline as well as throughout the study. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to ECG evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
1369121|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and Physical Examination|Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed at baseline and throughout the study. The TEAEs related to vital signs in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
1369122|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, potassium, sodium, bicarbonate, aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase, total bilirubin, liver function test, gamma glutamyl transferase [GGT], lactate dehydrogenase, uric acid, creatinine, blood urea nitrogen [BUN], glucose, albumin, total protein, triglycerides, cholesterol, and troponin); and routine urinalysis. The TEAEs related to laboratory evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
1369123|NCT01577745|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)|A serious AE (SAE) is any AE that results in death (refers to an event, which risk of death at the time of the event; it does not refer to an event that may have led to death), is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs defined as SAEs present at baseline that worsened in intensity after administration of study drug or SAEs absent at baseline that emerged after administration of study drug. The SAEs were summarized using MedDRA version 18.1.|From the first dose of MEDI0639 until the end of participation in the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
1369124|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the last dose of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.|From the first dose of MEDI0639 until 90 days after the last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||participants|||Number
1369135|NCT01577706|Primary|Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)||||percent change||Inter-Quartile Range|Median
1369125|NCT01577745|Primary|Maximum Tolerated Dose (MTD) of MEDI0639|The MTD evaluation was based on the dose-limiting toxicity (DLT) evaluable population. DLT is defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT evaluation period (defined as the time from the first dose of MEDI0639 to 21 days after the first dose), except for National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hypertension that could be controlled within 96 hours; Grade 3 symptomatic hypertension of greater than (>) 180 millimetre of mercury (mm Hg) systolic or >120 mm Hg diastolic or asymptomatic hypertension of >200 mm Hg systolic or >120 mm Hg diastolic was considered a DLT.|From the first dose of MEDI0639 to 21 days after the first dose|All participants enrolled in the dose-escalation phase who received at least 1 full cycle of MEDI0639 and completed safety follow-up through the DLT evaluation period or experienced any DLT.|||milligram (mg)|||Number
1369126|NCT01577732|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30).|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
1369127|NCT01577732|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
1369128|NCT01577732|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
1369129|NCT01577732|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
1369130|NCT01577706|Primary|Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Dextroamphetamine. Another participant is missing GABA levels both at t2 and t4 while on Dextroamphetamine. Another participant is missing GABA levels at both t2 and t4 while on Alprazolam.|||percent change||Inter-Quartile Range|Median
1369131|NCT01577706|Primary|Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Dextroamphetamine.|||percent change||Inter-Quartile Range|Median
1369132|NCT01577706|Primary|Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant ismissing GABA level at t4 while on Dextroamphetamine|||percent change||Inter-Quartile Range|Median
1369133|NCT01577706|Primary|Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)||||percent change||Inter-Quartile Range|Median
1369134|NCT01577706|Primary|Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Placebo, and one participant is missing GABA level at t2 while on Alprazolam.|||percent change||Inter-Quartile Range|Median
1369151|NCT01577381|Secondary|Accumulation Ratio (Rac) for AUCt||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369136|NCT01577706|Primary|Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)||||percent change||Inter-Quartile Range|Median
1369137|NCT01577628|Secondary|Time of Onset of Atopic Dermatitis|Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369138|NCT01577628|Secondary|Adverse Events (AEs) Collection|Adverse events (Skin AEs, asthma, food allergies, allergic rhinitis and any AE related to Lipikar Syndet, Lipikar Balm AP (group 1) or any other moisturizer application (group 2) will be collected.|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369139|NCT01577628|Secondary|Time of Onset of Food Allergy in Infants|Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369140|NCT01577628|Secondary|Time of Onset of Asthma in Infants|Time of onset of asthma in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369141|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop a Food Allergy|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369142|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Asthma|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369143|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Atopic Dermatitis|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369144|NCT01577628|Secondary|Proportion of Infants Who Develop a Food Allergy|Proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369145|NCT01577628|Secondary|Proportion of Infants Who Develop Asthma|Proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369146|NCT01577628|Primary|Proportion of Infants Who Develop Atopic Dermatitis|Proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
1369147|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369148|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369149|NCT01577381|Secondary|Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)|Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369150|NCT01577381|Secondary|Plasma Population PK Parameters|Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.|Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369152|NCT01577381|Secondary|Clearance at Steady State (CLss)|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)|Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369153|NCT01577381|Secondary|Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369154|NCT01577381|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369155|NCT01577381|Secondary|Maximum Observed Plasma Concentration (Cmax)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369156|NCT01577381|Secondary|Number of Participants With Treatment-Related TEAEs|An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least one dose of study product.|||Participants|||Number
1369157|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
1369158|NCT01577381|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|The number of participants with positive ADA was to be summarized for each treatment arm.|Day 57 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369159|NCT01577381|Secondary|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.|Days 28, 57, 85, 113 and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369160|NCT01577381|Secondary|Number of Participants With Abnormal Change From Baseline in Vital Signs|Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.|Screening, Days 28, 57, 85, 113, 141, and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369161|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Laboratory Abnormalities|Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.|Day 85 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369162|NCT01577381|Secondary|Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369163|NCT01577381|Secondary|Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369164|NCT01577381|Secondary|Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369165|NCT01577381|Secondary|Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369166|NCT01577381|Secondary|Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369167|NCT01577381|Secondary|Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369168|NCT01577381|Secondary|Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369169|NCT01577381|Secondary|Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369170|NCT01577381|Secondary|Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369171|NCT01577381|Secondary|Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369172|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369173|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1372662|NCT01536405|Secondary|Percentage of Participants With Mumps-like Symptoms||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1369174|NCT01577381|Secondary|Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369175|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369176|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369177|NCT01577381|Secondary|Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369178|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)|GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).|Baseline and Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369179|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309|GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).|Baseline and Day 309|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
1369180|NCT01577329|Primary|Changes in Respiratory Rate|Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight. During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.|baseline and at week eight||||Breaths per minute||Standard Deviation|Mean
1369181|NCT01577186|Other Pre-specified|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
1369182|NCT01577186|Other Pre-specified|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
1369183|NCT01577186|Primary|Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1369184|NCT01577186|Secondary|Social Functioning Scale (SFS) Score|The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1369185|NCT01577186|Primary|Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.|End of study (Up to Week 12)|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1369186|NCT01577160|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
1369187|NCT01577160|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
1369188|NCT01577160|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.|||participants|||Number
1369189|NCT01577160|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
1369190|NCT01577160|Primary|Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as “1: very much improved” or “2: much improved” on the CGI-I scale at Week 12.|Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1369191|NCT01577108|Primary|Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth|To exam the GBS colonization in both vagina and rectum when childbirth. The purpose of this study is to examine whether oral taking Lactobacillus-containing probiotics can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive.|2 weeks after taking probiotic|The GBS colonization results changed from positive to negative in 21 women in the probiotic group (42.9%) and in nine women in the placebo group (18.0%) during this period.|||Participants|||Count of Participants
1369192|NCT01576952|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.|||participants|||Number
1369193|NCT01576939|Secondary|How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose?|"The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMDQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.~This outcome measures pain in the mouth only.~This outcome is not a combination of several sub-scales. This outcome was the response to a single question: On a scale from 0 to 10, what number best describes the MOUTH PAIN that you experienced in the past 24 hours?~Mouth pain scale was measured as a single scale from 0 (no pain) to 10 (worst pain imaginable)."|3 years|Only 29 out of the 30 subjects filled out the pain surveys|||units on pain scale||95% Confidence Interval|Mean
1369194|NCT01576939|Secondary|How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose|"The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMWQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.~This outcome measures soreness in both the mouth and throat.~This outcome is not a combination of several sub-scales. This outcome was the response to the single question: On a scale from 0 to 10, how would you rate your OVERALL MOUTH AND THROAT SORENESS during the past 24 hours?~Mouth and throat soreness was measured as a single scale from 0 (no soreness) to 10 (worst soreness possible)."|3 years||||units on soreness scale||95% Confidence Interval|Mean
1369195|NCT01576939|Secondary|Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use|The narcotics use was a patient reported measurement that was documented in the medical note in the patient chart. Patient self reported measurements are generally known to be unreliable.|3 years||||mg||95% Confidence Interval|Mean
1369196|NCT01576939|Primary|Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed.|"The duration of grade 2 or higher oral mucositis was measured as the time from the first time oral mucositis was observed by a clinician at the weekly checkup until the oral mucositis was resolved.~The data was analyzed in a mixed effects model to account for the within subject correlation, since each patient contributed two measurements to the data set. The model was limited to those subjects who had experienced mucositis and then the outcome was the duration of grade 2 or higher mucositis. This allowed us to model the data in a mixed effects model with the continuous outcome of duration of grade 2 or higher mucositis."|3 years|For each subject, both left and right sides were included as two measurements from the same individual.|||Days||95% Confidence Interval|Mean
1369197|NCT01576939|Primary|Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.|"The time to onset of oral mucositis was measured from the start of radiation treatment until oral mucositis was visual observed by a clinician during the weekly checkup for the first time. Analysis done by Kaplan-Meier.~Adverse events were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version (V) 4.0. Medical doctor performed evaluation and grading of clinical and functional mucositis for the measured site weekly during the radiation treatment course and biweekly after completion of radiation until oral mucositis was < grade 2. A pain medication assessment was done for each mucositis time point. Patients completed the Oral Mucositis Weekly Questionnaire-Head and Neck cancer (OMWQ-HN) during and after treatment until oral mucositis is < grade 2."|3 years|The entire cohort was analyzed|||Days||95% Confidence Interval|Median
1369198|NCT01576809|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour||||participants|||Number
1369199|NCT01576809|Secondary|Subject Acceptability of the Syrup|"In response to the question How did you like the warming sensation you have experienced for this product?, the number of patients answering Like extremely or Like very much or Like moderately or Like slightly~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour||||participants|||Number
1369200|NCT01576809|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation|1 minutes||||mm||Standard Deviation|Mean
1369201|NCT01576718|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.|||liters/minute||Standard Error|Least Squares Mean
1369211|NCT01576718|Secondary|The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12|"The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma. Worsening asthma was defined as:~clinic visit FEV1 below the FEV1 stability limit value calculated on Day 1.~any 7-day run-in or treatment window (using information from the patient diary) during which the subject experienced:~3 or more days in which the highest PEF has fallen below the PEF stability limit calculated on Day 1~3 or more days in which ≥12 inhalations/day of albuterol/salbutamol was used~2 or more days in which the subject experienced a nighttime asthma symptom score of >2~clinical asthma exacerbation, defined as worsening asthma requiring any treatment other than study drug or rescue albuterol/salbutamol including the use of systemic corticosteroids and/or ER visit or hospitalization.~Patients who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment."|Day 1 to Week 12|Full analysis set|||probability||95% Confidence Interval|Number
1369202|NCT01576718|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.|||liters/minute||Standard Error|Least Squares Mean
1369203|NCT01576718|Other Pre-specified|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model which includes data from all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.|||liters||Standard Error|Least Squares Mean
1369204|NCT01576718|Secondary|24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint|24-hour urinary cortisol excretion was determined from 24-hour pooled-urine samples; urine was refrigerated until return to the investigational site after each 24-hour collection period. Urine was collected within 7 days of Day 1 and within 7 days of Week 12. Urine cortisol sample collection was not required at endpoint visit for subjects who terminated early from the study.|Baseline (Day 1), Week 12, Endpoint|Urine cortisol analysis set|||nmol/day||Standard Deviation|Mean
1369205|NCT01576718|Secondary|Patients With Positive Swab Test Results for Oral Candidiasis|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.~This outcomes indicates how many patients had positive swab test results. The total number of patients who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol."|Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12|Safety analysis set|||participants|||Number
1369206|NCT01576718|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety analysis set|||participants|||Number
1369207|NCT01576718|Secondary|Time Of Maximum Observed Plasma Concentration (Tmax)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.|||hours||Standard Deviation|Mean
1369208|NCT01576718|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.|||pg/mL||Standard Deviation|Mean
1369209|NCT01576718|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.|||pg*hr/mL||Standard Deviation|Mean
1369210|NCT01576718|Secondary|Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods|"The change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model, with the response being the proportion of rescue-free 24-hour periods. The model included 2 time points of measurement for each subject: the baseline (the last 7 days before the treatment period) and the treatment period. The model contained covariates for sex, age, and treatment. Rescue-free days were as indicated in patient diaries.~Data values are estimated means."|Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)|Full analysis set including participants who contributed at least once to the analysis.|||percentage of total 24 hour periods||Standard Error|Mean
1380879|NCT01451398|Secondary|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population|||percentage of participants|||Number
1369212|NCT01576718|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; evening PEF data for Flovent Diskus is reported in outcome #14.|||liters/minute||Standard Error|Least Squares Mean
1369213|NCT01576718|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject’s diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; morning PEF data for Flovent Diskus is reported in outcome #13.|||liters/minute||Standard Error|Least Squares Mean
1369214|NCT01576718|Primary|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug, and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; FEV1 data for Flovent Diskus is reported in outcome #12.|||liters||Standard Error|Least Squares Mean
1369215|NCT01576549|Secondary|Percent Change in Various Cell Types in the Blood From Baseline up to Week 24|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 24|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
1369216|NCT01576549|Primary|Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 16|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
1369217|NCT01576549|Primary|Percent Change in Synovial B Cell Mass From Baseline up to Week 16|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 16|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
1369218|NCT01576549|Primary|Percent Change in Synovitis Scores From Baseline up to Week 16|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 16|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
1369219|NCT01576471|Primary|Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI)|CDAI >= 100 point reduction from baseline|12 weeks|all patients randomized and treated with at least 1 dose of study medication|||Participants|||Count of Participants
1369220|NCT01576367|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|pre-vaccine dose, Day 28 post-vaccine|"Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study. Out of 20 unique patient-vaccination cases, 17 cases were assessable for a vaccination response whereas for the remaining 3 cases no pre-dose antibody titer was available,"|||vaccination cases|Participants||Number
1369221|NCT01576367|Secondary|Frequency Counts of Physician’s Global Assessment of Autoinflammatory Disease and Skin Disease|Participants were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe|minimum of 6 months and maximum of 24 months|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study|||Percentage of participants|||Number
1369256|NCT01575873|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)|Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 12|Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.|||percent change||95% Confidence Interval|Least Squares Mean
1369222|NCT01576367|Secondary|Change From Baseline (Core Study Baseline) in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations|CRP and SAA were used as serologic inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Week 0, 80, 104, 128 and 152, last assessment|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study|||(mg/L)||Standard Deviation|Mean
1369223|NCT01576367|Secondary|Immunogenicity of Canakinumab (ACZ885). Number of Participants With Anti-canakinumab Antibodies|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|minimum of 6 months and maximum of 24 months|Extension Safety set consisted of all patients from the core study who received at least one dose of study drug in the extension study and had at least one post-treatment safety assessment. Of note, the statement that a patient had no AE also constituted a safety assessment.|||Participants|||Number
1369224|NCT01576367|Primary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Serological Inflammation Markers.|Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal. Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe.|Week /80, 104, 128, and 152 (A minimum of 6 months and maximum of 24 months)|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study|||Percentage of participants|||Number
1369225|NCT01576341|Secondary|Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)|Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)|52 weeks|Per-protocol population (all patients that received at least one dose of study drug) with non-missing Hemoglobin value at Visit 16 (end of study).|||g/dL||Standard Deviation|Mean
1369226|NCT01576341|Primary|Anti-Erythropoietin (EPO) Antibodies|The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay|52 weeks|Safety population: The safety population consists of all patients that received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
1369227|NCT01576276|Primary|Pain Ratings|The primary endpoint was the morphine and ketorolac conditioning effects as indicated by subjective pain rating changes between pain only (a control condition with no injection of glucose, but subject's did see an image of an hour glass displaying how much time they had before receiving a painful stimulus) and pain+glucose (subjects received a glucose injection accompanied by an injection schematic followed by a painful stimulus) within the morphine and ketorolac groups. We used the Gracely pain rating scale (ranging from 0, no sensation to 20, extremely painful).|One day||||units on a scale||Standard Deviation|Mean
1369228|NCT01576276|Primary|fMRI Signal Changes|Obtain information about brain activity, including BOLD (Blood-oxygen-level dependent) signal, using an fMRI system. Data analysis was applied using SPM 12 with a standard pipeline.|one day|Here we present the average fMRI (functional MRI) signal changes of clusters that survived a threshold of 0.005 with10 continuous voxels. We only reported beta values in pain related areas.|||Beta value||Standard Deviation|Mean
1369229|NCT01576159|Secondary|Physiological (Maximum Oxygen Consumption) Changes of Participants||Baseline and 12 weeks||||ml/kg/min||Standard Deviation|Mean
1369230|NCT01576159|Secondary|Physical (Body Mass Index) Changes of Participants||Baseline and 12 weeks||||kg/m^2||Standard Deviation|Mean
1369231|NCT01576159|Primary|Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises||Baseline and 12 weeks||||U/l||Standard Deviation|Mean
1369232|NCT01576146|Secondary|Percent Change From Baseline in Serum Phosphorus|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).~The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13."|Baseline and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).|||percent change||Standard Error|Mean
1369233|NCT01576146|Secondary|Percent Change From Baseline in Serum Corrected Calcium|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).~The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13."|Baseline and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).|||percent change||Standard Error|Mean
1369234|NCT01576146|Secondary|Percent Change From Baseline in Parathyroid Hormone|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).~The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13."|Baseline (of the parent study 20120331) and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).|||percent change||Standard Error|Mean
1369235|NCT01576146|Primary|Number of Participants With Adverse Events||From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.|Participants who received at least one dose of etelcalcetide in the extension study|||participants|||Number
1369257|NCT01575873|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)|Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 12|Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.|||percent change||95% Confidence Interval|Least Squares Mean
1369236|NCT01576120|Primary|• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients|"effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment~The duration of the procedure in this study is 1 day of colon preparation and~1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted."|The end points and outcomes measures will be evaluated within 4 months from end of enrollment||||percentage of adequate cleansing||95% Confidence Interval|Number
1369237|NCT01576055|Secondary|Number of Participants With Device Success|Successful delivery of stent to the intended site and successful stent deployment.|Immediately following initial device implant (usually within a few minutes to an hour).|Per Protocol Population|||participants|||Number
1369238|NCT01576055|Secondary|Number of Participants With Procedural Success|Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.|Within 48 hours of initial device implant|Per Protocol Population|||participants|||Number
1369239|NCT01576055|Primary|Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months|Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.|12 Months|Per Protocol Population (Participants Available for 12-Month Follow-Up)|||participants|||Number
1369240|NCT01576055|Primary|Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days|Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).|30 Days|Per Protocol Population (Participants Available for 30-Day Follow-Up)|||participants|||Number
1369241|NCT01576042|Secondary|Number of Participants Received Treatment Assigned|Records participants who received study randomized treatment during the study|6 months||||participants|||Number
1369242|NCT01576042|Secondary|Time to First Recurrent ICD Therapy for VT|Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.|Baseline, 6 months||||Days||Standard Deviation|Mean
1369243|NCT01576042|Secondary|Number of Participants Switched to Other Arm|Records participants who received study treatment as randomized and later switched to other treatment arm during the study|6 months||||participants|||Number
1369244|NCT01576042|Secondary|Number of Participants Remained on Randomized Treatment Assignment|Records participants who only received study treatment as randomized during the entire study|6 month||||participants|||Number
1369245|NCT01576042|Secondary|Cardiovascular Hospitalizations|Records participants hospitalized for VT during the study|Baseline, 6 months||||participants|||Number
1369246|NCT01576042|Secondary|Number of Participants Had at Least One of the Efficacy Outcome Measurement|Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)|6 Months||||participants|||Number
1369247|NCT01576042|Secondary|Number of Participants Completed Month 6 Follow-Up|Records participants who completed Month 6 Follow-Up Visit|6 Months||||participants|||Number
1369248|NCT01576042|Primary|Number of Participants Completed Month 3 Follow-Up|Records participants who completed Month 3 Follow-Up Visit|3 months||||participants|||Number
1369249|NCT01575912|Primary|Visual Analog Scale Evaluation for the Pre-fixed Pressure Test|"pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia.~The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain."|one month|analysis per arm group|||units on a scale||Standard Deviation|Mean
1369250|NCT01575899|Secondary|Eradication Rate of Participants Living in Rural Area.|Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.|4 weeks after complete use of drug for treatment|Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan.|||percentage of eradicated participants|||Number
1369251|NCT01575899|Other Pre-specified|Re-eradication Rate|Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.|4 weeks after complete use of drug for treatment|This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.|||percentage of successful re-eradication|||Number
1369252|NCT01575899|Primary|Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)|A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.|4 weeks after complete use of drug for treatment|Intent to treat analysis of eradication (negative result of follow up method) measured 4 weeks after complete the treatment, for participants never received anti-H. pylori treatment before.|||percentage of eradicated participants|||Number
1369253|NCT01575873|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24|Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 24|Randomized participants with a baseline and month 24 measurement for the total hip BMD.|||percent change||95% Confidence Interval|Least Squares Mean
1369254|NCT01575873|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24|Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 24|Randomized participants with a baseline and month 24 measurement for the lumbar spine BMD.|||percent change||95% Confidence Interval|Least Squares Mean
1369255|NCT01575873|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12|Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 12|Randomized participants with a baseline and month 12 measurement for the total hip BMD.|||percent change||95% Confidence Interval|Least Squares Mean
1369258|NCT01575808|Secondary|Rate of Avoidance of Blood Transfusion||Post-Procedure||||Participants|||Count of Participants
1369259|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|24 months|||||||
1369260|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|12 months||||units on a scale||Standard Deviation|Mean
1369261|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|6 months||||units on a scale||Standard Deviation|Mean
1369262|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|3 months||||units on a scale||Standard Deviation|Mean
1369263|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|1 month||||units on a scale||Standard Deviation|Mean
1369264|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|24 months|||||||
1369265|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|12 months||||units on a scale||Standard Deviation|Mean
1369266|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|6 months||||units on a scale||Standard Deviation|Mean
1369267|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|3 months||||units on a scale||Standard Deviation|Mean
1369268|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|1 month||||units on a scale||Standard Deviation|Mean
1369269|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented|||||||
1369270|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented||||ABI||Standard Deviation|Mean
1369271|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented||||ABI||Standard Deviation|Mean
1369272|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented||||ABI||Standard Deviation|Mean
1369273|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure),|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented||||ABI||Standard Deviation|Mean
1369274|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|24 months|||||||
1369275|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|12 months||||Participants|||Count of Participants
1369303|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|24 months|||||||
1369276|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|6 months||||Participants|||Count of Participants
1369277|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|3 months||||Participants|||Count of Participants
1369278|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 – Asymptomatic Stage 1 – Mild claudication Stage 2 – Moderate claudication Stage 3 – Severe claudication Stage 4 – Rest pain Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 – Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|1 month||||Participants|||Count of Participants
1369279|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||24 months|||||||
1369280|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369281|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369282|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369283|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369284|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|24 months|||||||
1369285|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369286|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369287|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369288|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369289|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|24 months|||||||
1369290|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369291|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369292|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369293|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369294|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|24 months|||||||
1369295|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369296|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369297|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369298|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
1369299|NCT01575808|Secondary|Technical Success|Placement of GP1101 with residual stenosis of less than 30%|Post-procedure||||Participants|||Count of Participants
1369300|NCT01575808|Secondary|Rate of Avoidance of Adverse Events|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|60 months|||||||
1369301|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|48 months|||||||
1369302|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|36 months|||||||
1369307|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||percent of participants||95% Confidence Interval|Number
1369308|NCT01575808|Secondary|Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)|Composite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure.|1 month||||Participants|||Count of Participants
1369309|NCT01575808|Primary|Rate of Avoidance of General Anesthesia|Percentage of study subjects avoiding general anesthesia|Day 0||||Participants|||Count of Participants
1369310|NCT01575808|Primary|Duration of Stay|Duration (in days) of post-procedure hospital stay|Up to discharge||||Days||95% Confidence Interval|Median
1369311|NCT01575808|Primary|Primary Assisted Patency|"Primary Efficacy Endpoint >~> Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion"|12 months||||Participants|||Count of Participants
1369312|NCT01575769|Secondary|Absolute C-Reactive Protein Levels||Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||milligrams per Liter||Standard Deviation|Mean
1369313|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Walking component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369314|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Reach component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369315|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Hygiene component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369316|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Grip component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369317|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Eating component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369318|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Dressing and Grooming component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369319|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Arising component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369320|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Activity component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1370413|NCT01563406|Secondary|Number of Contaminated Central Venous Catheter Tips|"This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as yes or no."|10 months|Unable to collect a sufficient number of catheter tips to analyze. Therefore, this outcome was dropped early in the study.||||||
1369321|NCT01575769|Secondary|Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A minimally important improvement was defined as at least a 0.13 improvement in CHAQ-DI score from baseline.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
1369322|NCT01575769|Secondary|Change From Baseline in Childhood Health Assessment – Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1369323|NCT01575769|Secondary|Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up||Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||millimeters per hour (mm/hour)||Standard Deviation|Mean
1369324|NCT01575769|Secondary|Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The participant or parent/guardian, as appropriate, provides a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||mm||Standard Deviation|Mean
1369325|NCT01575769|Secondary|Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The physician provides a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||mm||Standard Deviation|Mean
1369326|NCT01575769|Secondary|Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The maximum number of joints with limitation of movement is 67 and these were defined as those with 'limitation of motion'.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||Joints||Standard Deviation|Mean
1369327|NCT01575769|Secondary|Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|Joint with active arthritis was defined as a joint with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||Joints||Standard Deviation|Mean
1369328|NCT01575769|Secondary|Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up|Clinical remission: inactive disease for minimum of 6 continuous months while on medication (Level 1); off oral corticosteroid medications but still on tocilizumab (Level 2); off both methotrexate and oral corticosteroids but still on tocilizumab (Level 3); or off all anti-arthritis medications-oral corticosteroids, methotrexate, non-steroidal anti-inflammatory drugs but still on tocilizumab (Level 4). Inactive disease: No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to sJIA; Normal ESR (<20 mm/hour); PGA of disease activity indicated no disease activity (score ≤10 mm on a 100 mm VAS where 0 [inactive arthritis] and 100 [very active arthritis]). Overall percentage of participants with clinical remission (any level) are reported.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
1369329|NCT01575769|Secondary|Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up|Criteria for Inactive Disease: 1) No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both), 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal ESR (less than [<] 20 millimeters per hour [mm/hour]), and 4) PGA of disease activity using VAS indicated no disease activity (where no disease activity is considered to be a score less than or equal to [≤]10 mm on a 100 mm VAS where left end of line 0 [inactive arthritis] to right end of line 100 [very active arthritis]).|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
1369351|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7= Among the most extremely ill patients. A higher score is associated with greater illness severity|baseline, week 12 (LOCF)|Only 375 of the 377 subjects had the CGI-BP-S mania assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369330|NCT01575769|Secondary|Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up|JIA ACR90 response was defined as 3 of any 6 core outcome variables improved by at least 90% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
1369331|NCT01575769|Secondary|Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up|JIA ACR70 response was defined as 3 of any 6 core outcome variables improved by at least 70% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
1369332|NCT01575769|Secondary|Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up|JIA ACR50 response was defined as 3 of any 6 core outcome variables improved by at least 50% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
1369333|NCT01575769|Secondary|Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up|JIA ACR30 response was defined as 3 of any 6 core outcome variables improved by at least 30% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: Physician global assessment (PGA) of disease activity using Visual Analog Scale (VAS) from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); Patient/parent global assessment (PtGA) of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and Erythrocyte Sedimentation Rate (ESR).|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
1369334|NCT01575769|Primary|Percentage of Participants With Adverse Events (AEs)|AE: unfavorable and unintended sign, symptom, or disease associated with use of treatment, regardless of treatment relation. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from treatment were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Severe AE: AE that caused inability to work or perform normal daily activity. AEs of special interest: Serious infections (including opportunistic infections), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related AE, Malignant neoplasms, Anaphylaxis event, Demyelination-related events, Stroke, Spontaneous or serious bleeding, Serious/medically significant hepatic events. Any AE included serious and non-serious AE.|Baseline to 12 weeks after last actual study medication (up to 101 weeks)|Safety population|||percentage of participants|||Number
1369335|NCT01575756|Secondary|Volume of Distribution at Steady State (Vss)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||mL/kg||Standard Deviation|Mean
1369349|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient’s life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|baseline, week 12 (LOCF)|only 297 of the 377 subjects had the SDS total score at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369336|NCT01575756|Secondary|Clearance|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||mL/h/kg||Standard Deviation|Mean
1369337|NCT01575756|Secondary|Mean Residence Time (MRT)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h||Standard Deviation|Mean
1369338|NCT01575756|Secondary|Terminal Half-life (t½)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h||Standard Deviation|Mean
1369339|NCT01575756|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h||Standard Deviation|Mean
1369340|NCT01575756|Secondary|Classical in Vivo Recovery|Classical in vivo recovery was calculated as: 100 x the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma) x the plasma volume (mL), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg).|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||percentage||Standard Deviation|Mean
1369341|NCT01575756|Secondary|Incremental in Vivo Recovery|Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg/kg dosed).|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||mg/dL/(mg/kg)||Standard Deviation|Mean
1369342|NCT01575756|Secondary|Maximum Plasma Concentration (Cmax) Standardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The maximum plasma concentration was standardized to a dose of 70 mg/kg.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||g•h/L||Standard Deviation|Mean
1371687|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): Baseline||Baseline|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline serum DHT result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
1369343|NCT01575756|Secondary|Maximum Plasma Concentration (Cmax) Unstandardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||g/L||Standard Deviation|Mean
1369344|NCT01575756|Secondary|Maximum Plasma Concentration Normalized (Cmaxnorm)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||kg•g/L/mg||Standard Deviation|Mean
1369345|NCT01575756|Secondary|Fibrinogen Activity Normalized Area Under the Curve Standardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||g•h/L||Standard Deviation|Mean
1369346|NCT01575756|Secondary|Fibrinogen Activity Normalized Area Under the Curve Unstandardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h•kg•g/L/mg||Standard Deviation|Mean
1369347|NCT01575756|Primary|Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion|Thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, the fibrinogen content primarily defined the maximum clot firmness.|1 hour post-treatment|Full analysis set: All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA®) and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available.|||mm||95% Confidence Interval|Mean
1369348|NCT01575756|Primary|Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The mean ratio of normalized area under the curve was calculated as Octafibrin/FIBRYGA® over Haemocomplettan® P/RiaSTAP(TM)|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||ratio||90% Confidence Interval|Mean
1369350|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S depression assessment at Week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369352|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)|Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S overall assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369353|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)|Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression.|baseline ,Week 12 (LOCF)|Only 375 of the 377 subjects had the MADRS assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369354|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)|Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline, 12 weeks (LOCF)|only 375 of the 377 subjects had the YMRD assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369355|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|baseline, 12 weeks (LOCF)|only 359 of the 377 subjects had the PANSS-P assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369356|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|baseline, 12 weeks (LOCF)|only 351 of the 377 subjects had the QIDS-SR16 assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1369357|NCT01575561|Primary|Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events|Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation|12 weeks||||participants|||Number
1369358|NCT01575522|Secondary|To Evaluate the Incidence of c-Met Positive Circulating Tumor Cells.||Baseline||||participants|||Number
1369359|NCT01575522|Secondary|To Evaluate Phospho c-Met Expression in Archival Tumor Tissue.|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline||||participants|||Number
1369360|NCT01575522|Secondary|To Evaluate c-Met Expression in Archival Tumor Tissue.|Assessment of ploidy status was done by visual screening of all tumor area; cells with maximum number of signals were recorded. MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline||||participants|||Number
1369361|NCT01575522|Secondary|Overall Response Using RECIST v1.1|The 95% confidence intervals should be provided. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Conventional CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >/=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year||||percentage of participants||95% Confidence Interval|Number
1369362|NCT01575522|Primary|PFS Status|Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from start of treatment to time of progression or death, assessed up to 6 months||||months||95% Confidence Interval|Median
1369363|NCT01575275|Secondary|Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index||From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 years||||months||Full Range|Median
1369364|NCT01575275|Secondary|Time to Disease Progression (TTP), Determined by Review of MRIs Performed Post Operatively as Clinically Indicated, Evaluated With Use of the New International Criteria Proposed by the Response in NeuroOncology (RANO) Committee||From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year|Outcome never analyzed. Closed with the IRB in 2014||||||
1372663|NCT01536405|Secondary|Percentage of Participants With Zoster-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1369365|NCT01575275|Primary|Comparison Between the Volume of Resected Tissue (Defined as the Volume of the Resection Cavity) and the Pre-operative Enhancing Tumor Volume|Volume of enhancing tumor (initial and residual) will be determined by use of a software-based volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).|Up to day 1|Outcome never analyzed. Study closed with the IRB in 2014||||||
1369366|NCT01575275|Primary|Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid|Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).|Day 1||||cc||Full Range|Median
1369367|NCT01575197|Secondary|SAE Assessment|Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor.|Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation|||||||
1369368|NCT01575197|Secondary|Vaccine-type Rotavirus Shedding in Stool|Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer’s specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take.|Days 4 and 7 post each study vaccination|||||||
1369369|NCT01575197|Secondary|Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination|The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution.|Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|||||||
1369370|NCT01575197|Secondary|IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 10 and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||titers||95% Confidence Interval|Geometric Mean
1369371|NCT01575197|Secondary|IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 6, 10, and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||titers||95% Confidence Interval|Geometric Mean
1369372|NCT01575197|Secondary|IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre- vaccination as measured by EIA.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||percentage of participants||95% Confidence Interval|Number
1369373|NCT01575197|Primary|Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA).|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and oral polio vaccine (OPV) according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||percentage of participants||95% Confidence Interval|Number
1369374|NCT01575106|Primary|fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex|We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).|Week 4|The neutral cream is omitted from the data table below because we were only concerned about the direct comparison between positive expectancy (“Lidocaine”) and negative expectancy (“Capsaicin”) conditions. Data were only collected for the Lidocaine and Capsaicin creams.|||Post-Pre treatment peak beta||Standard Deviation|Mean
1385152|NCT01405794|Secondary|Total Change in Systolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days||||mmhg||95% Confidence Interval|Mean
1369375|NCT01575106|Primary|Subjective Response to Pain (0-20 Visual Analogue Scale)|Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.|Weeks 1-3||||units on a scale||Standard Error|Mean
1369376|NCT01575080|Secondary|Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements|Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.|1 hour||||participants|||Number
1369377|NCT01575080|Secondary|Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot using the Contour TS BG Monitoring System. One subject was unable to obtain sufficient sample volume to test. Another subject's meter displayed|||Number of BG Test Results|Participants||Number
1369378|NCT01575080|Secondary|Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System|||Number of BG Test Results|Participants||Number
1369379|NCT01575080|Primary|Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System.|||Number of BG Test Results|Participants||Number
1369380|NCT01575054|Secondary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1369381|NCT01575054|Secondary|Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale|The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = “no pain” to 10 = “pain as bad as can be imagined”. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1369382|NCT01575054|Secondary|Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)|The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from −3 to 2 (−3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented.|Week 8|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1369383|NCT01575054|Secondary|Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale|The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline.|Baseline, 6 weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1369384|NCT01575054|Primary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
1370774|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum|Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set|||ratio||95% Confidence Interval|Least Squares Mean
1369385|NCT01575028|Primary|Post-operative Pain Relief|Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.|12 hours post-operatively|Due to changes in surgical technique & protocols by the general surgeons, we were only able to recruit 3 study subjects and the study was terminated. No analysis was performed.||||||
1369386|NCT01574703|Secondary|Incidence of MACE+ Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
1369387|NCT01574703|Secondary|Incidence of MACE Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
1369388|NCT01574703|Secondary|Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
1369389|NCT01574703|Secondary|Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
1369390|NCT01574703|Secondary|Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
1369391|NCT01574703|Secondary|Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
1369392|NCT01574703|Secondary|Time to MACE Until the End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||Unitless||95% Confidence Interval|Number
1369393|NCT01574703|Secondary|Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||Unitless||95% Confidence Interval|Number
1369394|NCT01574703|Primary|Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||Unitless||95% Confidence Interval|Number
1369395|NCT01574651|Secondary|"Symptoms Score Reported by the Patients Using Part I Symptoms of SGRO-C"|Part I of the SGRQ-C covers “symptoms” and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived “weight”. A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Score on a scale||Standard Deviation|Mean
1370775|NCT01560234|Primary|Summary for Lymphocytes Laboratory Results||Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)|Safety Analysis Set|||cells*10^9/L||Standard Deviation|Mean
1369396|NCT01574651|Secondary|FEV1 30 Min After the Morning Dose at Baseline and Week 26|FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Liters||Standard Deviation|Mean
1369397|NCT01574651|Secondary|Trough FEV1 at Baseline and Week 26|Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Liters||Standard Deviation|Mean
1369398|NCT01574651|Secondary|Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period|The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Participants|||Number
1369399|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Hospitalization|The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Percent of participants|||Number
1369400|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks|The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Percent of participants|||Number
1369401|NCT01574651|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.|Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Units on a scale||Standard Deviation|Mean
1369402|NCT01574651|Secondary|St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George’s Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Score on a scale||Standard Deviation|Mean
1369403|NCT01574651|Primary|St. George’s Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated.|||Score on a scale||Standard Deviation|Mean
1369404|NCT01574612|Primary|Reporting of Adverse Events|treatment period is for 5 days and follow up visits at 7days and 21 days after first dose|day 1 to day 21||||participants|||Number
1369512|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 16|Estimated mean change in body weight after 16 Weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.|||kg||Standard Error|Mean
1369405|NCT01574326|Secondary|Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus|Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.|Baseline, Week 28/Early Termination|FAS-DTP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after Week 2. Five participants (3 in sevelamer carbonate group and 2 in the placebo group) were excluded from the FAS-DTP due to no baseline phosphorus value or no phosphorus assessment after Week 2.|||mg/dL||Standard Deviation|Mean
1369406|NCT01574326|Primary|Treatment – Emergent Adverse Events (AEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.|Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)|Analysis was performed on safety set, which included all enrolled participants who received at least 1 dose of study drug. Participants were analyzed according to actual received treatment.|||participants|||Number
1369407|NCT01574326|Primary|Change From Baseline (Week 0) to Week 2 in Serum Phosphorus|Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.|Baseline, Week 2|FAS-FDP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline assessment after the first dose of study drug and on or before Week 2. Three participants (1 in sevelamer carbonate group and 2 in placebo group) were excluded from FAS-FDP due to no baseline phosphorus value at week 2.|||mg/dL||Standard Deviation|Mean
1369408|NCT01574248|Secondary|Systolic Blood Pressure|Average of blood pressure measurements from zero to forty-eight hours provided.|T0 to T48 hours||||mmHg||Standard Deviation|Mean
1369409|NCT01574248|Secondary|Number of Participants Given Epinephrine||T0 to T48 hours||||Participants|||Count of Participants
1369410|NCT01574248|Secondary|Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers||T0 to T48 hours||||Participants|||Count of Participants
1369411|NCT01574248|Secondary|Number of Participants Given Steroids||T0 to T48 hours||||Participants|||Count of Participants
1369412|NCT01574248|Secondary|Number of Participants With Requirement for Intubation||T0 to T48 hours||||Participants|||Count of Participants
1369413|NCT01574248|Secondary|Number of Participants With Admission to Intensive Care Unit||T0 to T48 hours||||Participants|||Count of Participants
1369414|NCT01574248|Primary|Time to Resolution of Angioedema|Time interval between initiation of treatment and when there is no symptom, by visual analog scale <1 cm. Data provided are for worst symptom.|48 hours||||hours||95% Confidence Interval|Median
1369415|NCT01574183|Secondary|Marijuana Craving and Withdrawal|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly to all participants. Reported here is the mean MCQ purposefulness subscale score across 8 weeks.|8 weeks||||units on a scale||95% Confidence Interval|Mean
1369416|NCT01574183|Secondary|Weekly Cannabis Use Sessions|Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption.|8 weeks||||weekly cannabis sessions||95% Confidence Interval|Mean
1369417|NCT01574183|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|8 weeks||||percentage of UDS|Participants||Number
1369418|NCT01574105|Secondary|Transfusion Events|Transfusion events to recorded will be the number of patients receiving units of red blood cells, units of platelets, units of plasma and units of cryoprecipitate.|Data collection begins with patient arrival in the operating room and ends with discharge from the ICU (normally less than 24hrs)||||Participants|||Number
1369419|NCT01574105|Primary|Chest Tube Losses|Chest tube losses will be measured in millilitres upon arrival in the Intensive Care unit (ICU) after six hours in the ICU and total chest tube losses during the ICU stay. Chest tube losses are the amount of blood collected in a graduated chest tube collection reservoir from chest tubes placed in the patient's chest wound at the end of surgery.|Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)||||millilters||Standard Deviation|Mean
1369420|NCT01574079|Secondary|Stroke Rehabilitation Assessment of Movement|The Stroke Rehabilitation Assessment of Movement (STREAM)is designed to measure mobility and motor ability after stroke. There are three subscales with 10 items each assessing the upper extremity, lower extremity, and basic mobility. Only the lower extremity and basic mobility items were used in this study. The lower extremity scores ranged from 0 - 18 with higher scores indicating a higher level of motor control. The basic mobility scores ranged from 0 - 30 with high numbers indicating a higher level of functional mobility.|measured at admission and discharge with estimated length of stay 14 days||||outcome score||Standard Deviation|Mean
1369421|NCT01574079|Secondary|Timed Up and Go|The Timed Up and Go (TUG) is used to assess balance and gait, and to estimate fall risks in patients with deficits. The participant rises from a seated position in a chair, walks 3 meters, turns around, returns to the chair, and sits down. The test is measured in seconds, with a lower number indicating a higher level of independence and the least risk for falls.|Measured at admission and discharge with estimated length of stay 14 days||||seconds||Standard Deviation|Mean
1369478|NCT01573000|Secondary|Duration of Response for All Confirmed Responders, Confirmed Complete Responders, and Confirmed Partial Responders|For all participants with CR, CCR, or PR, duration of response was defined as the time from first documented response to first documented progression. All confirmed responders included participants with CR, CCR, and PR, whereas confirmed complete responders included participants with CR and CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for CR, CCR, or PR were analyzed.|||months||95% Confidence Interval|Median
1369422|NCT01574079|Primary|Functional Independence Measure - Locomotor Score|The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence.|measured at admission and discharge from rehab estimated length of stay 14 days|Thirty-three participants enrolled in the study with 3 dropping out before completion. Two of these were due to medical issues, and one was discharged unexpectedly|||outcome score||Standard Deviation|Mean
1369423|NCT01573910|Primary|Microbiological Success Rate|Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.|||percentage of participants|||Number
1369424|NCT01573910|Primary|Clinical Cure Rate|Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.|||percentage of participants|||Number
1369425|NCT01573767|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 4-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1369426|NCT01573767|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1369427|NCT01573767|Secondary|Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1369428|NCT01573767|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1369429|NCT01573767|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 4-week Treatment Period minus the value at Baseline. The Baseline value is defined as the value at Visit 3 (randomization). Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline; Week 1 up to Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1369510|NCT01572740|Secondary|Number of Adverse Events (AEs)|An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Week 0 to Week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Events/100 years of patient exposure|||Number
1369556|NCT01572298|Secondary|Percentage of New Bone Formation (Histologic)||5 months after surgery|No data were collected for this outcome||||||
1369430|NCT01573767|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline in trough FEV1 at the end of the 4-week Treatment Period was defined using the pre-dose FEV1 measurement taken at the Week 4 clinic visit. Change from Baseline was calculated as the Week 4 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1369431|NCT01573767|Primary|Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.|Baseline; Week 1 up to Week 4|ITT Population: participants randomized to treatment who received >=1 dose of study medication|||Liters per minute (L/min)||Standard Error|Least Squares Mean
1369432|NCT01573624|Secondary|Mean Change From Baseline in Rescue Albuterol/Salbutamol Use of Each Treatment Period.|Short-Acting Beta2-Agonists albuterol/salbutamol was provided to participants as rescue medication, to use in morning and evening. Participants recorded number of puffs of salbutamol MDI used in last 24 hours (sum of night time and day time puffs) daily for relief of symptoms in eDiary. Mean change from baseline was calculated where, baseline was defined as measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 (for night time puffs) and seven days (for day time puffs) for each treatment period. Change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and the baseline week. Analysis was done using a mixed model, including treatment, period, period baseline rescue albuterol use, and mean baseline rescue albuterol use as fixed effects and participant as random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Number of puffs||Standard Error|Least Squares Mean
1369433|NCT01573624|Secondary|Mean Change From Baseline in Daily Evening (Pre-dose and Pre-rescue Bronchodilator) PEF of Each Treatment Period|PEF is a measure of lung function and measures how fast a person can breathe out. Evening PEF was measured pre-dose and pre-rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and seven days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline evening PEF and mean baseline evening PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1369434|NCT01573624|Secondary|Mean Change From Baseline in Daily Morning (Pre-dose and Pre-rescue Bronchodilator) Peak Expiratory Flow (PEF) of Each Treatment Period|PEF is a measure of lung function and measures how fast a person can breathe out. Morning PEF was measured pre-dose and pre- rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline morning PEF and mean baseline morning PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Litres per min (L/min)||Standard Error|Least Squares Mean
1369435|NCT01573624|Primary|Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. The highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as the FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. The change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Analysis was done using a mixed model, including treatment, period, period baseline FEV1, and mean baseline FEV1 as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Day 1) and Day 15 of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Litres (L)||Standard Error|Least Squares Mean
1369436|NCT01573624|Primary|Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Data is presented as percentage chance that FF 100 mcg alone corrected change from baseline trough FEV1 response would exceed a target response of 50 mL, 75 mL, 100 mL and 150 mL by doses of UMEC combined with FF 100 mcg.|Baseline (Day 1) and Day 15 of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percentage chance|||Number
1369437|NCT01573624|Primary|Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1)|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Slope-intercept on log dose model was used to predict trough FEV1 change from baseline for each of the FF+UMEC doses adjusted by FF 100 mcg alone. Mean value for the expected response and associated 95% confidence interval (CI) in change from baseline trough FEV1 is presented.|Baseline (Day 1) and Day 15 of each treatment period|The primary endpoint was analyzed using Intent -to -Treat (ITT) Population defined as all participants randomized to treatment and who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Litres (L)||95% Confidence Interval|Mean
1369438|NCT01573325|Secondary|Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL|Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.|2-3 months|Entire study population was analyzed|||percentage of participants|||Number
1369439|NCT01573325|Primary|Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.|Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.|2-3 months|Entire study population was analyzed|||scores on a scale||Standard Deviation|Mean
1369440|NCT01573260|Secondary|Adverse Events|Adverse events will be queried week 12 through a semi structured interview querying increase in falls, fatigue, pain, cramps or pain, in addition to open-ended questions regarding other potential adverse events. Events will be rated by the patient and investigator as mild, moderate, or serious. All serious adverse events will be reported to the research ethics board|12 weeks||||percentage of participants|||Number
1369441|NCT01573260|Secondary|Exit Questionnaire|An exit questionnaire ranking level of enjoyment and overall satisfaction with their dance/exercise program, scored from 1 (strongly agree) to 5 (strongly disagree), with open questions about willingness continuing practicing tango.|12 weeks||||units on a scale||Standard Deviation|Mean
1369442|NCT01573260|Secondary|Clinical Global Impression of Change|"Completed by both the examiner and the patient, the scale is a single question Since you have enrolled in the study, how has your Parkinson's disease changed?. It will be scored as very much improved (6), much improved (5), minimally improved (4), no change (3), minimally worse (2), much worse (1), or very much worse(0)."|26 weeks||||units on a scale||Standard Deviation|Mean
1369443|NCT01573260|Secondary|Adherence to Treatment|Compliance with dance therapy will be conducted by reconfirming the regular assistance to the dance sessions at week 12, to compare how many sessions were attended by the participants. The dance instructors will keep the track of dance classes’ assistance.|12 weeks||||participants|||Number
1369444|NCT01573260|Secondary|The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)|The PDQ-39 is a quality of life index for PD. It consists of a 39-item questionnaire that asks about the impact of PD on a person's motor function, gait, mood, cognition, and activities of daily living. Patients are asked to indicate the frequency of each event by selecting one of 5 options: never/occasionally/sometimes/often/always or cannot do at all. Total score is ranging from 0 (best possible outcome) to 156 (worst possible quality of life).|26 weeks||||score||Standard Deviation|Mean
1369445|NCT01573260|Secondary|The Krupp Fatigue Severity Scale|The fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question It has been validated, and has been used in PD studies. Total score is ranging from 0 (best possible outcome) to 63 (worst possible fatigue).|26 weeks||||score||Standard Deviation|Mean
1369446|NCT01573260|Secondary|Apathy Evaluation Scale (AES)|This is a 14-item patient-rated scale which measures cognitive, emotional, and behavioural symptoms of apathy. All items are rated on a 0 to 3 Likert Scale. The original 18-item scale has been shortened by four items, and wording simplified and it was reported to have excellent psychometric properties in PD (internal consistency reliability = 0.76, test-retest 1 week r = 0.90). Total score is ranging from 0 (best possible outcome) to 42 (worst possible symptoms).|26 weeks||||score||Standard Deviation|Mean
1369447|NCT01573260|Secondary|The Beck Depression Inventory (BDI)|"The BDI is a self-administered scale of 21 items (scored 0-3) which assesses depression symptoms. The Beck Inventory is one of the most commonly-used scales for depression in PD, and a recent consensus panel of the Movement Disorders Society concluded it was a scale of first choice for assessing depression in PD. Total score for the BDI is the sum of 21 items, ranging from 0 (best possible outcome) to 63 (worst possible symptoms)"|26 weeks||||score||Standard Deviation|Mean
1369448|NCT01573260|Secondary|The Montreal Cognitive Assessment|"This tool was designed to screen for mild cognitive impairment. This includes visuospatial tests (clock drawing, trail making, cube copying), confrontation naming, attention (digit span, backwards digit span, A test, sentence repetition), tests of verbal fluency, abstraction, short term memory, and orientation. Recently, it has been used widely in PD, and demonstrates excellent sensitivity for subtle cognitive deficits. Alternate versions (7.1 to 7.3, with a randomly-distributed order) will be administered to prevent training effects. Total score for the MoCA is the sum of eight subscales, ranging from 0 (worst possible outcome) to 30 (best possible symptoms)"|26 weeks||||score||Standard Deviation|Mean
1369449|NCT01573260|Secondary|The Purdue Pegboard|The Purdue Pegboard, a test of dexterity and speed in the hands will be assessed over 1 minute. We calculate the number of pins correctly placed on the board in a minute.|26 weeks||||correct pins per 60 sec||Standard Deviation|Mean
1369450|NCT01573260|Secondary|Freezing of Gait Questionnare (FOG_Q)|Freezing of gait will be assessed using the Freezing of Gait Questionnare (FOG_Q), a 6-item tool measuring walking and freezing episodes. Higher scores indicate greater difficulty with walking and freezing. Six items each scored from 0 to 6 were summed to obtain the total score, ranging from 0 (best possible outcome) to 36 (worst possible outcome).|26 weeks||||units on a scale||Standard Deviation|Mean
1369451|NCT01573260|Secondary|Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging|Falls will be assessed using an adapted version of the falls questionnaire from the Canadian Longitudinal Study of Aging focusing on the past 3 months. This questionnaire includes 2 questions to assess if the participants felt during the past year and then it assess if this fall happened within the last 3 months. If a participant answered 'yes' to both questions, then the participant screened positive for this outcome. In the results section, we reported the number of participant who answered 'Yes' to both questions.|26 weeks||||participants|||Number
1369452|NCT01573260|Secondary|MiniBESTest|Balance will be assessed using a 14-item tool measuring performance of dynamic balance tasks. This test has high interrater and test-retest reliability in PD (intraclass correlation coefficient ≥ .92 and intraclass correlation coefficient ≥.88 respectively). Total score for MiniBESTest is the sum of foursubscales, ranging from 0 (worst possible balance) to 28 (best possible balance). Lower scores indicate greater deficits in balance. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, we used of both left and right data, thus calculating data based on 32 (vs 28) points.|26 weeks||||units on a scale||Standard Deviation|Mean
1369453|NCT01573260|Primary|Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)|This is the standard scale used for grading severity of PD. It starts with a patient self-administered questionnaire covering activities of daily living, motor symptoms, and non-motor domains. It also includes a systematic rated clinical interview assessing cognitive and psychiatric symptoms and motor complications of disease. A Hoehn and Yahr scale (5-point overall disease severity index) is included. Finally, there is a formal examination component (Part III) (performed in the medication 'on' state for this study). Total score for Unified Parkinson Disease Rating Scale is the sum of six subscales, ranging from 0 (best possible outcome) to 60 (worst possible symptoms)|26 weeks||||units on a scale||Standard Deviation|Mean
1369454|NCT01573000|Secondary|Time to Human Anti-Murine Antibodies (HAMA) Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of human anti-mouse antibodies.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were evaluated.|||days||Standard Deviation|Mean
1369455|NCT01573000|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|"ITT-Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."|||days||Full Range|Median
1369456|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||participants|||Number
1369457|NCT01573000|Secondary|Nadir Values for the Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||cells/microliter||Full Range|Median
1369458|NCT01573000|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||Grams/dL||Full Range|Median
1369557|NCT01572298|Primary|Gain in Horizontal Ridge Dimension||5 months after surgery||||gain in ridge width (mm)||Standard Deviation|Mean
1373644|NCT01525407|Secondary|Grades II-IV Acute GVHD|Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.|First 100 days after transplant||||probability||95% Confidence Interval|Number
1369459|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST confirmed PR. Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
1369460|NCT01573000|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated.|||Cells/millimeters cubed (mm^3)||Full Range|Median
1369461|NCT01573000|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values. Hematologic laboratory evaluations included ANC, hemoglobin (Hb), platelets (Plt), and WBC count.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated. The numbers analyzed in the category titles reflect the number of participants with the event of interest plus the number of participants who were censored. A censored value indicates that the participant did not have the event of interest.|||days||Full Range|Median
1369462|NCT01573000|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any fatal SAE were analyzed.|||participants|||Number
1369463|NCT01573000|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any SAE were analyzed.|||participants|||Number
1369464|NCT01573000|Secondary|Number of Participants With a Time to Death From the Last Dose of Study Drug Less Than or Equal to 30 Days or More Than 30 Days|"Time to death from the last dose of study drug is the time from the last dose of study drug administered to the date of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.|||participants|||Number
1369465|NCT01573000|Secondary|Number of Participants With the Indicated Primary Cause of Death|"Participants were categorized according to their primary cause of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.|||participants|||Number
1369466|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Drug-related AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 drug-related AEs experienced by 3 or more participants were analyzed.|||participants|||Number
1369467|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 AEs experienced by 3 or more participants were analyzed.|||participants|||Number
1369468|NCT01573000|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.|||participants|||Number
1369469|NCT01573000|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||participants|||Number
1369470|NCT01573000|Secondary|Number of Participants With the Indicated Drug-Related (DR) Adverse Events (AEs) Experienced by 3 or More Participants|"An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Causality of AEs was determined by the investigators as none, remote, possible, probable, or highly probable. AEs considered by the investigator as being at least remotely related to the study treatment were considered to be DR AEs. White blood cell (WBC) count and absolute neutrophil count (ANC) were measured as cells per millimeters cubed (mm^3); hemoglobin was measured in grams per deciliter (g/dL)."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any drug-related adverse events were analyzed.|||participants|||Number
1369471|NCT01573000|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death by any cause.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
1369472|NCT01573000|Secondary|MIRROR Panel Assessed Progression-free Survival|Time from the date of enrollment (the date of randomization) to the first documented progression or death.|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||months||95% Confidence Interval|Median
1369473|NCT01573000|Secondary|MIRROR Panel Assessed Time to Response (Time From the Date of Enrollment to the First Documented Response (PR, CR, CCR)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||days||95% Confidence Interval|Median
1369474|NCT01573000|Secondary|Time to Progression of Disease or Death in Participants Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment and those who progressed/died were analyzed. Participants who experienced progression or died (n=18, 17) and participants who were censored (n=1, 2) were analyzed. A censored value indicates that the participant did not have the event of interest.|||months||95% Confidence Interval|Median
1369475|NCT01573000|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who experienced progression or died (n=36, 33) and participants who were censored (n=6, 3) were analyzed. A censored value indicates that the participant did not have the event of interest.|||months||95% Confidence Interval|Median
1369476|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Confirmed Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||months||95% Confidence Interval|Median
1369477|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Complete Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.|||months||95% Confidence Interval|Median
1369742|NCT01569841|Secondary|Glycosylated Haemoglobin (HbA1c)|HbA1c after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1369479|NCT01573000|Secondary|Number of Participants (Par.) With a Confirmed Response (CR, CCR, or PR) as Assessed by the MIRROR Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1369480|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1369481|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR + CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
1369482|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1369483|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CCR. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
1369484|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1369485|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
1369486|NCT01573000|Primary|Number of Participants (Par.) With a Confirmed Complete Response as Assessed by the Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1369487|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1369511|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 36|Estimated mean change in body weight after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.|||kg||Standard Error|Mean
1372240|NCT01542502|Primary|Peak Oxygen Consumption (Peak VO2)|The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).|14 days||||ml*kg^-1*min^-1||Inter-Quartile Range|Median
1369488|NCT01573000|Primary|Number of Participants With Confirmed Response Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease (defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters [cm] in diameter by radiographic evaluation or >1 cm in diameter by physical examination.) were assessed separately before and after receiving the crossover treatment of I 131 TST for confirmed response, which included participants with CR, CCR, and PR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
1369489|NCT01573000|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1369490|NCT01572948|Secondary|Induced Sputum Neutrophil Count||3 months after baseline||||percentage of sputum neutrophils||Standard Error|Mean
1369491|NCT01572948|Secondary|Induced Sputum Neutrophil Count||baseline||||percentage of sputum neutrophils||Standard Error|Mean
1369492|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization||3 months after baseline||||ng/ml||Standard Deviation|Mean
1369493|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.||1 month after baseline||||ng/ml||Standard Deviation|Mean
1369494|NCT01572948|Secondary|Induced Sputum Neutrophil Count||1 month||||percentage of sputum neutrophils||Standard Error|Mean
1369495|NCT01572948|Primary|Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline||baseline||||ng/ml||Standard Deviation|Mean
1369496|NCT01572844|Secondary|Change in Patient Functionality and/or Quality of Life.|This will be assessed through the use of the Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (CHAQ), Manual Muscle Testing (MMT8), and range of motion evaluations. DLQI index scores range from 0 to 30. The higher the score, the more quality of life is impaired.Change in scores from baseline to final assessment yielding a negative percent change indicate an improvement in DLQI. HAQ scales range from 0 to 3. The higher the score, the greater the disability. Change in scores from baseline to final assessment yielding a negative percent change indicate an improvement in the HAQ. MMT8 testing results in a score between 0 and 150. The higher the score, the more normal the function of the muscle. A positive percent change would indicate an improvement in MMT8 testing results.|Change from Visit 1 to Visit 12 (week 20)|The arms/groups does not apply to this outcome measure. Lesions were not analyzed in these assessments. Overall Patient functionality and quality of life were evaluated via questionnaires, manual muscle testing, and range of motion evaluations. No changes in range of motion were noted for either subject.|||percentage of change from baseline|||Number
1369497|NCT01572844|Secondary|Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies.|Change in dermatomyositis-associated calcinosis as measured by a difference in centimeters in plain film (x-ray) studies. X rays were compared between baseline and final assessment for any changes.|Change from Visit 2 to Visit 12 (week 20)|No change was observed for any lesion.|||cm|lesion|Standard Deviation|Mean
1369498|NCT01572844|Secondary|Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales.|Change in dermatomyositis-associated calcinosis of a single lesion by assessing its severity as measured by a difference in Patient Calcinosis Visual Analog Scales. The scale ranges from zero (0) to ten (10). Zero (0) being no evidence of disease activity and ten (10) being extremely active or severe disease activity. A negative change would indicate improvement in the disease activity. A positive change would indicate worsening of disease activity.|Change from Visit 2 to Visit 12 (week 20)||||Percentage of change|lesions||Number
1369499|NCT01572844|Secondary|Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Hardness as Measured by a Difference in Durometer (Rex Durometer Model 1600, Type OO) Measurements.|Change in dermatomyositis-associated calcinosis of a single lesion by assessing its hardness as measured by a difference in durometer (Rex durometer Model 1600, Type OO) measurements. The range of a durometer is from 0 to 100. The higher the durometer reading, the harder the lesion. Improvement in the lesion hardness would result in a negative change over time.|Change from Baseline (Visit 1) at Final Assessment (Visit 12, week 20).|2 subjects were enrolled and each subject has 2 lesions that were followed through the study. Each subject has one area that was marked as treatment lesion and also has an area that was used as a control (no treatment lesion). Overall, there were 2 subjects, 2 treatment lesions and 2 no treatment lesions.|||percentage of change|lesions||Number
1369500|NCT01572844|Primary|Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales.|Change in dermatomyositis-associated calcinosis of a single lesion by assessing its severity as measured by a difference in Physician Calcinosis Visual Analog Scales. The Visual Analog Scale range is from zero (0) to ten (10). Zero (0) being no evidence of disease activity and ten (10) being extremely active or severe disease activity. A negative percent change indicates improvement in the lesion.|Change from Visit 2 to Visit 12 (week 20)||||percentage change|lesion||Number
1369743|NCT01569841|Secondary|Fasting Plasma Glucose (FPG)|FPG after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||mmol/L||Standard Deviation|Mean
1369501|NCT01572792|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)|"Potentially clinically significant change:~Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline Pulse rate ≥110 bpm and increase ≥15% from baseline or ≤50 bpm and decrease ≥15% from baseline Weight increase or decrease ≥7% from baseline~The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study"|Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
1369502|NCT01572792|Other Pre-specified|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).|Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Scores on a scale||Standard Error|Least Squares Mean
1369503|NCT01572792|Other Pre-specified|Transition Dyspnea Index (TDI) Focal Score at End of Study|"The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate no change. The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9."|Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Scores on a scale||Standard Error|Least Squares Mean
1369504|NCT01572792|Other Pre-specified|Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)||Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Liters||Standard Error|Least Squares Mean
1369505|NCT01572792|Other Pre-specified|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Liters||Standard Error|Least Squares Mean
1369506|NCT01572792|Secondary|Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value||Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
1369507|NCT01572792|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis|"Potentially clinically significant change:~>1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid <0.85 x lower limit of normal (LLN) or > 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH <0.95 x LLN or >1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity >1.1 × ULN~The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study"|Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
1369508|NCT01572792|Primary|Percentage of Patients to Experience Any Treatment-emergent Adverse Event|For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study|Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
1369509|NCT01572740|Secondary|Number of Confirmed Hypoglycaemic Episodes|"A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.~Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL)."|Week 0 to week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Episodes/100 years of patient exposure|||Number
1369513|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 13 subjects did not contribute to the statistical analysis at Week 36 due to missing data.|||mmol/L||Standard Error|Mean
1369514|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.|||mmol/L||Standard Error|Mean
1369515|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 8 subjects did not contribute to the statistical analysis at Week 36 due to missing data.|||mmol/L||Standard Error|Mean
1369516|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.|||mmol/L||Standard Error|Mean
1369517|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.|||mmol/L||Standard Error|Mean
1369518|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|Estimated mean change from baseline in FPG after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.|||mmol/L||Standard Error|Mean
1369519|NCT01572740|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36|Estimated mean change from baseline in HbA1c after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.|||percentage of glycosylated haemoglobin||Standard Error|Mean
1369520|NCT01572740|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16|Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.|||percentage of glycosylated haemoglobin||Standard Error|Mean
1369521|NCT01572727|Secondary|Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)|Time to definitive deterioration of the ECOG performance status from baseline|every 4 weeks|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the time to definitive deterioration of ECOG performance status was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
1369522|NCT01572727|Secondary|Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)|Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days|Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the plasma concentration-time profiles was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
1369523|NCT01572727|Secondary|Clinical Benefit Rate (CBR) (Phase ll)|CBR was defined as the percentage of patients with an overall response of CR or PR or SD or non-CR/non-PD lasting more than 24 weeks based on local Investigator’s assessment according to RECIST v1.1.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.|||Percentage of participants||95% Confidence Interval|Number
1369524|NCT01572727|Secondary|Time to Response (Phase Lll)|time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, time to response was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
1369525|NCT01572727|Secondary|Duration of Response (Phase Lll)|time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the duration of response was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
1369526|NCT01572727|Secondary|Overall Response Rate (Phase ll)|Percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. According to this criteria, CR = at least two determinations of CR at least 4 weeks apart before progression; PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.|||Percentage of participants||95% Confidence Interval|Number
1369527|NCT01572727|Secondary|Overall Survival by Kaplan-Meier Estimate (Phase ll)|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.|every 3 months until death, lost to follow-up, or withdrawal of consent to survival follow-up, up to 10 months after futility was analyzed|Full analysis set (FAS) comprises all patients who were randomized to study treatment.|||Months||95% Confidence Interval|Median
1369528|NCT01572727|Primary|Progression-free Survival (PFS)Assessed by Local Investigator’s Assessment (Phase ll)|PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.|||Months||95% Confidence Interval|Median
1369529|NCT01572675|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study|||Participants|||Number
1369530|NCT01572675|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study|||Participants|||Number
1369531|NCT01572675|Secondary|Number of Participants With Contraindications for Use of Arcoxia®|Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.|At study entry|The safety population consisting of all participants who enrolled in the study with data of sufficient quality for analysis of the endpoint (contraindications)|||Participants|||Number
1369532|NCT01572675|Secondary|Number of Participants Switching to Another Treatment With the Same Reason for Prescription|Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
1369533|NCT01572675|Secondary|Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®|Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (other prior agents)|||Participants|||Number
1369534|NCT01572675|Secondary|Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®|Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.|Up to 12 months|All participants in compliance with study inclusion criteria with at least one follow-up visit (with an available prescription file) other than the end-of-study visit were used for analysis of the endpoint|||Participants|||Number
1369535|NCT01572675|Secondary|Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-prescriptions at entry)|||Participants|||Number
1369536|NCT01572675|Secondary|Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®|'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (past treatments)|||Participants|||Number
1369537|NCT01572675|Secondary|Co-morbidities in Participants Treated With Arcoxia® and Celebrex®|Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-morbidities)|||Participants|||Number
1369538|NCT01572675|Secondary|Medical History of Participants Treated With Arcoxia® and Celebrex®|Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (medical history)|||Participants|||Number
1369539|NCT01572675|Secondary|Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BP)|||Participants|||Number
1369540|NCT01572675|Secondary|Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (SBP and DBP)|||mmHG||Standard Deviation|Mean
1369541|NCT01572675|Secondary|Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BMI)|||kg/m^2||Standard Deviation|Mean
1369542|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use According to Duration of Treatment|Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
1369543|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use|The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
1369544|NCT01572675|Primary|Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®|The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
1369545|NCT01572675|Primary|Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®|Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||mg/day||Standard Deviation|Mean
1369546|NCT01572675|Primary|Total Duration of Treatment With Arcoxia® and Celebrex®|The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)|||Days||Standard Deviation|Mean
1369973|NCT01568008|Secondary|Patient Assessment of Treatment Tolerability Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
1369547|NCT01572675|Primary|Duration of Prescription for Arcoxia® and Celebrex® at Enrollment|The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)|||Days||Standard Deviation|Mean
1369548|NCT01572675|Primary|Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®|Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
1369549|NCT01572675|Primary|Mean Dosage of Arcoxia® and Celebrex® During Treatment|The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||mg/day||Standard Deviation|Mean
1369550|NCT01572675|Primary|Dosage of Arcoxia® and Celebrex® at Initiation|Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (dosage at initiation)|||Participants|||Number
1369551|NCT01572675|Primary|Indications for Which Arcoxia® and Celebrex® Were Prescribed|The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (indication)|||Participants|||Number
1369552|NCT01572675|Primary|Reasons for Misuse of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (misuse)|||Participants|||Number
1369553|NCT01572675|Primary|Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|All participants with complete data relative to correct use of the coxib and at least 1 data point relative to misuse of the coxib.|||Participants|||Number
1369554|NCT01572389|Primary|Change in Patient Health Questionnaires-9 During Intervention|"The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent minimal symptoms of depression; 10 - 14 represent minor depression, dysthymia, or major depression - mild; 15 - 19 represent major depression, moderately severe; and scores of 20 and above is considered major depression, severe. Participants with that scored a 10 or above were eligible for the study."|PHQ-9 will be assessed at baseline, 6-, and 12- months.|The number analyzed at each timepoint decreased due to non-completion of the assessment by participants.|||units on a scale||Standard Deviation|Mean
1369555|NCT01572389|Primary|Change in Hemoglobin A1C|Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.|Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.|The number analyzed at each timepoint decreased due to non-completion of the A1C blood draw by participants.|||percentage of glycated hemoglobin||Standard Deviation|Mean
1369558|NCT01572207|Secondary|Changes From Baseline in Quality of Life|The Multiple Sclerosis Impact Scale will be administered. The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome). Therefore, the lower the number, the better the outcome.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).||||scores on a scale||Full Range|Mean
1369559|NCT01572207|Secondary|Changes From Baseline in Physical Fitness|The physical assessment will include measuring the 6-minute walk test. The units reported are in meters for distance traveled by each participant during the six minutes. For this scale, the higher number is the better score as it is a direct measure of distance traveled.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).||||meters||Full Range|Mean
1369560|NCT01572207|Primary|Changes From Baseline in Physical Activity Behavior|"Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean.~With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity."|Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).||||scores on a scale||Full Range|Mean
1369561|NCT01571557|Secondary|Mean Change From Baseline in Central Retinal Thickness|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.|Baseline, Week 24|All enrolled patients with complete data at this time point|||micrometers (μm)||Standard Deviation|Mean
1369562|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.|Baseline, 48 Weeks|All enrolled patients|||Percentage of Patients|||Number
1369563|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.|Baseline, 48 Weeks|All enrolled patients|||Percentage of Patients|||Number
1369564|NCT01571557|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are “approximate ETDRS letters” to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.|Baseline, Week 12|All enrolled patients with complete data at this time point|||Approximate EDTRS Letters||Standard Deviation|Mean
1369565|NCT01571453|Secondary|Number of Adverse Events||Baseline to Week 12|||||||
1369566|NCT01571453|Secondary|Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||percentage of patients|||Number
1369567|NCT01571453|Secondary|MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||percentage of patients|||Number
1369568|NCT01571453|Secondary|Change in HAM-A Total Score From Baseline to Week 8|Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
1369586|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
1369569|NCT01571453|Secondary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.|Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
1369570|NCT01571453|Secondary|Change in CGI-S Score From Baseline to Week 8|Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
1369571|NCT01571453|Primary|Change From Baseline in MADRS Total Score at Week 8|Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
1369572|NCT01571362|Secondary|Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period|Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol|Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||pg/mL||Standard Deviation|Mean
1369573|NCT01571362|Secondary|Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period|Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone|Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||ng/mL||Standard Deviation|Mean
1369574|NCT01571362|Secondary|Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period|Cobs of naltrexone and 6-β-naltrexol|Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline|Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.|||pg/mL||Standard Deviation|Mean
1369575|NCT01571362|Secondary|Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period|Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.|Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline|Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.|||ng/mL||Standard Deviation|Mean
1369576|NCT01571362|Secondary|Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||days||Inter-Quartile Range|Median
1369577|NCT01571362|Secondary|Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||mg||Inter-Quartile Range|Median
1369578|NCT01571362|Secondary|Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||days||Standard Deviation|Mean
1369579|NCT01571362|Secondary|Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||mg||Standard Deviation|Mean
1369580|NCT01571362|Secondary|Median Oxycodone Duration of Titration During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||days||Inter-Quartile Range|Median
1369581|NCT01571362|Secondary|Median Oxycodone Average Daily Dose During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||mg||Inter-Quartile Range|Median
1369582|NCT01571362|Secondary|Mean Oxycodone Duration of Titration During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||days||Standard Deviation|Mean
1369583|NCT01571362|Secondary|Mean Oxycodone Average Daily Dose During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||mg||Standard Deviation|Mean
1369584|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain|Question 3b: nights stayed in the hospital|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of nights||Standard Deviation|Mean
1369585|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain|Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
1369974|NCT01567943|Secondary|Psychiatric Symptomology|Brief Symptom Inventory; Positive and Negative Symptom Scale|throughout 7 months of study|||||||
1369975|NCT01567943|Secondary|Community Outcomes|(jail bookings, ER visits, mental health and substance abuse service utilization)|entire study period, and three month prior and after study involvement|||||||
1369587|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Weeks 4, 8, and 12|ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Post Screening value for each treatment and visit. Imputation using the LOCF method.|||Percentage of participants|||Number
1369588|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital|Question 3b: nights stayed in the hospital|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of nights||Standard Deviation|Mean
1369589|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments|Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.|Randomization Baseline, Weeks 4, 8, and 12|ITT Population, imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
1369590|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
1369591|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)|ITT Population; the denominator for the percentage calculation is the number of participants who had both Randomization Baseline value and Post Randomization value for each treatment and visit. Imputation using the LOCF method.|||Percentage of participants|||Number
1369592|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital|Question 3b: nights stayed in the hospital, if answer to Q3a was yes.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of days||Standard Deviation|Mean
1369593|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks|Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
1369594|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
1369595|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital|Question 3b: nights stayed in the hospital, if answer to Q3a was yes.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of days||Standard Deviation|Mean
1369596|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks|Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
1369597|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
1369598|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Randomization Baseline|ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Randomization Baseline value.|||Percentage of participants|||Number
1369599|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; the denominator for the percentage calculation is the number of participants who had both Screening value and End of Open-Label value.|||Percentage of participants|||Number
1369614|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
1369600|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369601|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369602|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369603|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369604|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369605|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369606|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369652|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index|Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369607|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
1369608|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Deviation|Mean
1369609|NCT01571362|Secondary|Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment.~work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Deviation|Mean
1369610|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1369611|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1369612|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Randomization Baseline, Week 12|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1369613|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health|Randomization Baseline, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1369682|NCT01571284|Primary|Number of Participants With Proteinuria Events|Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria were analyzed by grades (Grades 1, 2, 3 ,4) as per NCI CTCAE Version 4.03 where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population.|||Participants|||Count of Participants
1369615|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
1369616|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
1369617|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index|The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
1369618|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1369619|NCT01571362|Secondary|Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Randomization Baseline, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1369620|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
1369621|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
1369622|NCT01571362|Secondary|Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period|Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).|Week 12 or Early Termination|ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
1369623|NCT01571362|Secondary|Satisfaction With Treatment at Randomization Baseline|Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.|Randomization Baseline|ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
1369976|NCT01567943|Secondary|Other Drug Use as Measured by Urinalysis||through 7 months of study|||||||
1369977|NCT01567943|Secondary|Self Report Drug Use||through 7 months of study|||||||
1369624|NCT01571362|Secondary|Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants|Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.|End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)|Titration Period Safety Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
1369625|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor|Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Randomization Baseline, Week 8|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 8 for each treatment.|||Percentage of participants|||Number
1369626|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Randomization Baseline, Week 4|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 4 for each treatment.|||Percentage of participants|||Number
1369627|NCT01571362|Secondary|Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Screening, Randomization Baseline, or Early Termination|Titration Period Safety Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.|||Percentage of participants|||Number
1369628|NCT01571362|Secondary|Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Screening, Randomization Baseline|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.|||Percentage of participants|||Number
1369629|NCT01571362|Secondary|Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Randomization Baseline, Weeks 2, 4, and 8|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Error|Least Squares Mean
1369630|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Screening, Weeks 2, 4, 8, and 12|ITT Population; imputation using the LOCF method for Week 12 only; Weeks 2, 4, 8 included observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Error|Least Squares Mean
1369631|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369632|NCT01571362|Secondary|Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant’s score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369978|NCT01567943|Secondary|Change in Intensive Outpatient Substance Abuse Treatment Attendance||During 16 weeks of treatment||||percentage of addiction tx attended||Standard Deviation|Mean
1369633|NCT01571362|Secondary|SOWS Total Score During the Post-Treatment Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Follow-Up Weeks 1 and 2|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369634|NCT01571362|Secondary|SOWS Total Score During the Double-Blind Treatment Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Randomization Baseline, Weeks 1, 2, 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369635|NCT01571362|Secondary|Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Screening, Weeks 1, 2, 3, 4, 5, and 6|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369636|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Follow-Up Weeks 1 and 2|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
1369637|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
1369638|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
1369639|NCT01571362|Secondary|COWS Total Score During the Post-Treatment Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Follow-Up (FU) Weeks 1 and 2|Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369640|NCT01571362|Secondary|COWS Total Score During the Double-Blind Treatment Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Randomization Baseline, Weeks 1, 2, 4, 8, and 12|Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369641|NCT01571362|Secondary|Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant’s signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Screening, Weeks 1, 2, 3, 4, 5, and 6|Titration Period Safety Population. Only participants with values at both Screening and each respective visit were included in the change from screening analysis; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
1369724|NCT01570244|Primary|Cmax,ss of Levonorgestrel|maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1369642|NCT01571362|Secondary|Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period|If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1].|Week 1 up to Week 12|ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.|||days||95% Confidence Interval|Median
1369643|NCT01571362|Secondary|Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy|If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.|Week 1 up to Week 12|ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.|||Percentage of participants|||Number
1369644|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period|The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].|Randomization Baseline, up to Week 12|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.|||days||95% Confidence Interval|Median
1369645|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period|The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].|Randomization Baseline, up to Week 12|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.|||Percentage of participants|||Number
1369646|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].|Screening, Randomization Baseline (up to 6 weeks)|ITT Population; an event was defined as a participant with 20%, 30%, 40% or 50% analgesic response from Screening.|||days||95% Confidence Interval|Median
1369647|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.|Screening, Randomization Baseline (up to 6 weeks)|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.|||Percentage of participants|||Number
1369648|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].|Screening, Week 4, 5, or 6|Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.|||days||95% Confidence Interval|Median
1369649|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.|Screening, Week 4, 5 or 6|Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.|||Percentage of participants|||Number
1369650|NCT01571362|Secondary|Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period|The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.|Daily from Day 1 of the Double-Blind Period through Week 12|ITT Population|||Average mg/day||Standard Error|Least Squares Mean
1369651|NCT01571362|Secondary|Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)|NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.|Randomization Baseline, Weeks 11 and 12|ITT Population; linear interpolation was used for internal missing values, with addition of 0 to the AUC for missing values from early discontinuation.|||Change in units on a scale*days||Standard Error|Least Squares Mean
1369653|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index|Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369654|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369655|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369656|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for least pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369657|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8 and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369658|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index|Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369659|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index|Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369660|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369661|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369662|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation by LOCF; n=number of participants assessed for least pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369663|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
1369664|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Screening, Randomization Baseline|ITT Population - observed cases; n=number of participants assessed for the given parameter at the specified timepoint.|||units on scale||Standard Deviation|Mean
1369680|NCT01571284|Primary|Number of Participants With Urinary Protein-Creatinine Ratio (UPCR)|Urinary protein creatinine ratio (UPCR) corresponds to the ratio of the urinary protein and urinary creatinine concentration (expressed in mg/dL). This ratio provides an accurate quantification of 24-hours urinary protein excretion. There is a high correlation between morning UPCR and 24-hour proteinuria in participants with normal or reduced renal functions. Normal ratio is < or = 1.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed = participants with available data for specified categories.|||Participants|||Count of Participants
1369665|NCT01571362|Secondary|Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Screening, Week 4, 5, or 6|Titration Period Safety Population: defined as all participants who received any amount of ALO-02 capsules during the Open-Label Conversion and Titration Period; imputation using the LOCF method. n=number of participants contributing to the mean for the specified parameter.|||Units on a Scale||Standard Deviation|Mean
1369666|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
1369667|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
1369668|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
1369669|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
1369670|NCT01571362|Secondary|Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).|Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).|Randomization Baseline, Week 12|ITT Population; percentage based on the number of participants who had non-missing values at Randomization Baseline and Week 12/early termination for each treatment. Imputation using LOCF method.|||Percentage of participants|||Number
1369671|NCT01571362|Secondary|Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).|The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant’s score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.|Week 12|ITT Population; imputation using last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1369672|NCT01571362|Primary|Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)|Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.|Weeks 11 and 12|Intent-to-Treat (ITT) Population: all participants who were randomized into the Double-Blind Treatment Period and received at least 1 dose of study drug after randomization; the averaged value for each participant from the 100 imputed datasets were used. Hybrid multiple and single imputation were applied, depending on reason for discontinuation.|||Units on a Scale||Standard Error|Least Squares Mean
1369673|NCT01571284|Secondary|Change From Baseline in HRQL EQ-5D-3L VAS Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and VAS. EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. The VAS recorded the respondent’s self-rated health on a vertical visual analogue scale. The VAS ‘thermometer’ has endpoints of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|EQ-5D analysis population. Here, 'Number Analyzed' = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
1369681|NCT01571284|Primary|Number of Participants With Proteinuria Grade >=2|Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population|||participants|||Number
1369674|NCT01571284|Secondary|Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI). Here, 'Number Analyzed' = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
1369675|NCT01571284|Secondary|Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant’s assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|"EORTC QLQ-C30 analysis population. Here, Number Analyzed = participants analyzed at specified timepoints."|||units on a scale||Standard Deviation|Mean
1369676|NCT01571284|Secondary|Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant’s assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28).Answers were converted into grading scale, with values between 0 and 100. A high score represented a favourable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|EORTC QLQ-C30 analysis population. Here, ‘Number Analyzed’ = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
1369677|NCT01571284|Secondary|Mean Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 Score): Global Health Status|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant’s assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favourable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at the end of treatment (EOT) (within 30 days of last treatment) (maximum exposure: 214 weeks)|EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI). Here, 'Number Analyzed' = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
1369678|NCT01571284|Primary|Number of Participants With Cycle Delay and/or Dose Modification|A theoretical cycle is a 2 week period i.e. 14 days. A cycle is delayed if duration of previous cycle is greater than 14+2 days ; dose modification includes dose reduction and dose omission.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population defined as the participants who signed the informed consent form and received at least one dose of study treatment.|||Participants|||Count of Participants
1369679|NCT01571284|Primary|Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension|Proteinuria is defined as the presence of excess proteins in the urine (assessed either by spot sample, dipstick/ urine protein or 24 hour urine collection). Hematuria is defined as the presence of blood in urine (positive dipstick for RBC or reported AE). Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event. Hypertension (high blood pressure) is defined as having a blood pressure reading of more than 140/90 mmHg over a number of weeks.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population.|||Participants|||Count of Participants
1369725|NCT01570244|Primary|AUCτ,ss of Levonorgestrel|Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1369683|NCT01571284|Primary|Number of Participants With Abnormal Non-Gradable Biochemistry Parameters|Non-gradeable biochemistry parameters included; chloride, urea, total protein, blood urea nitrogen (BUN) and lactate dehydrogenase (LDH). Number of participants with <lower limit of normal ranges (LLN) and >upper limit of normal ranges (ULN) for each of these parameters were reported.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed = participants with available data for specified categories.|||Participants|||Count of Participants
1369684|NCT01571284|Primary|Number of Participants With Other Abnormal Biochemistry Parameters|Other abnormal biochemistry parameters included: hypoglycemia, hyperglycemia and hypoalbuminemia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE Version 4.03, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
1369685|NCT01571284|Primary|Creatinine Clearance of Aflibercept Plus FOLFIRI|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance was calculated using the Cockroft-Gault or Modification of Diet in Renal Disease (MDRD).|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Overall number of participants analyzed = participants evaluable for this outcome measure.|||mL/min||Standard Deviation|Mean
1369686|NCT01571284|Primary|Number of Participants With Abnormal Renal and Liver Function Parameters|Renal and liver function parameters included: creatinine, hyperbilirubinemia, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
1369687|NCT01571284|Primary|Number of Participants With Abnormal Electrolytes Parameters|Abnormal electrolytes parameters included: hyponatremia, hypernatremia, hypocalcemia, hypercalcemia, hypokalemia, and hyperkalemia. Number of participants with each of these parameters were analyzed by grades ( All Grades and Grades 3-4 as per NCI CTCAE Version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
1369688|NCT01571284|Primary|Number of Participants With International Normalized Ratio (INR)|The INR is a derived measure of the prothrombin time. The INR is the ratio of a participant's prothrombin time to a normal control sample. Normal range (without anti coagulation therapy): 0.8-1.2; Targeted range (with anti coagulation therapy) 2.0-3.0.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
1369689|NCT01571284|Primary|Number of Participants With Abnormal Hematological Parameters|Abnormal hematological parameters included: anaemia, thrombocytopenia, leukopenia and neutropenia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4 as per NCI CTCAE (Version 4.03), where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed = participants with available data for specified categories.|||Participants|||Count of Participants
1369690|NCT01571284|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.|||Participants|||Count of Participants
1369691|NCT01571232|Secondary|The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.|To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.|6 months||||nV/deg2||Standard Error|Mean
1369692|NCT01571232|Secondary|The Change in Mean Macular Sensitivity on Microperimetry From Baseline|To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.|6 months|||||||
1369693|NCT01571232|Secondary|The Change in Macular Leakage on Fluorescein Angiography From Baseline|To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.|6 months|||||||
1369694|NCT01571232|Primary|The Change in Central Foveal Thickness (Microns on High Resolution OCT).|The measure the change in central foveal thickness for each treatment group from baseline to 6 months.|6 months||||microns||Standard Error|Mean
1369695|NCT01571232|Primary|The Change in Visual Acuity (Number of ETDRS Letters).|The measure the change in ETDRS letters for each treatment group from baseline to 6 months.|6 months||||ETDRS letters||Standard Error|Mean
1369696|NCT01570751|Secondary|Number of Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.|From baseline to the end of each 16 week treatment period.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1369697|NCT01570751|Secondary|Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.|Week 16, week 20|The FAS included all randomised subjects and missing data was imputed using LOCF. For 19 subjects the FPG values were missing.|||mmol/L||Standard Deviation|Mean
1369698|NCT01570751|Secondary|Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period|Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.|Week 0, week 16, week 32|The FAS included all randomised subjects and missing data was imputed using LOCF. For 17 subjects in IDeg treatment A and 16 subjects in IGlar treatment B, FPG values were missing at the period of baseline and did not contribute to the analysis.|||mmol/L||Standard Deviation|Mean
1369699|NCT01570751|Secondary|Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 16, week 20|The FAS included all randomised subjects. For 10 subjects, the PRO scores were missing.|||scores on a scale||Standard Deviation|Mean
1369700|NCT01570751|Secondary|Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period|Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure–Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 0, week 16 of each treatment period.|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects in each treatment group the values were missing at the period of baseline and did not contribute to the analysis.|||scores on a scale||Standard Deviation|Mean
1369701|NCT01570751|Primary|Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period|Values for change in HbA1c after each 16 weeks of treatment periods A and B.|Week 0, week 16 of each treatment period.|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects in IDeg treatment A and 7 subjects in IGlar treatment B, HbA1c values were missing at the period of baseline and did not contribute to the analysis.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1369702|NCT01570686|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||8 weeks|Safety Set (SAF): consisted of all patients who received at least one dose of randomized study medication.|||Patients|||Number
1369703|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRC are included in this analysis.|||ng/L||Standard Deviation|Mean
1369704|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Activity (PRA)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRA are included in this analysis.|||ng/mL/hr||Standard Deviation|Mean
1369705|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.|||Hour||Standard Deviation|Mean
1369706|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.|||ng*h/mL||Standard Deviation|Mean
1369707|NCT01570686|Secondary|Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations|||ng/mL||Standard Deviation|Mean
1369726|NCT01570244|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events|from drug administration up to 14 days|treated set|||participants|||Number
1369708|NCT01570686|Secondary|Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction|Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting SBP measurement at baseline and over 8 weeks were included in this analysis.|||Percentage of patients|||Number
1369709|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with official mean sitting blood pressure measurements both at baseline and week 8 were icluded in this analysis.|||mmHg||Standard Error|Least Squares Mean
1369710|NCT01570686|Secondary|Percentage of Patients Achieving Blood Pressure Control|Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg|8 weeks|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting blood pressure measurement over 8 weeks were included in this analysis.|||Percentage of patients|||Number
1369711|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
1369712|NCT01570686|Primary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
1369713|NCT01570634|Secondary|Side-effects and Complications|Compare side-effects and complications|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
1369714|NCT01570634|Secondary|Absence of Relapse|Compare sustained clinical response|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
1369715|NCT01570634|Secondary|Resolution of Abdominal Pain|Compare time to resolution of abdominal pain|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
1369716|NCT01570634|Secondary|Stools Per Day|Compare the number of liquid stools per day during treatment period|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
1369717|NCT01570634|Primary|Resolution of Diarrhea|To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).|42 days|The study was terminated early due to slow enrollment. Of the 2 patients enrolled, one took less than 50% of the prescribed study drug. The results are not evaluable.||||||
1369718|NCT01570309|Primary|Inflammation|Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups|Baseline to week 12||||pg/ml||Inter-Quartile Range|Median
1369719|NCT01570309|Primary|Inflammation|Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks||||pg/ml||Inter-Quartile Range|Median
1369720|NCT01570309|Primary|Inflammation|Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks||||pg/ml||Inter-Quartile Range|Median
1369721|NCT01570309|Primary|Inflammation -|Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups|Baseline and 12 weeks||||mg/dl||Inter-Quartile Range|Median
1369722|NCT01570309|Primary|Endothelial Function|Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post –to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.|Baseline and 12 weeks|Assuming a standard deviation of 0.6 in the change in RH-PAT score from baseline to 12 weeks, we estimated that the study would need a sample size of 45 patients per treatment group to have 80% power at a two tailed alpha=0.05 level to detect a minimum difference in change in RH-PAT score of 0.36 between treatment groups.|||reactive hypermia index||Inter-Quartile Range|Median
1369723|NCT01570244|Primary|C24,ss of Levonorgestrel|measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1369727|NCT01570244|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 14 days|Treated set: This subject set included all 16 subjects who were administered trial medication and were documented to have taken at least 1 dose of investigational treatment.|||participants|||Number
1369728|NCT01570244|Primary|C24,ss of Ethinylestradiol|measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1369729|NCT01570244|Primary|Cmax,ss of Ethinylestradiol|maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1369730|NCT01570244|Primary|AUCt,ss of Ethinylestradiol|Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, who did not have important protocol violations relevant to the evaluation of PK endpoints, and who did not have vomiting until 2·median tmax,ss of ethinylestradiol or levonorgestrel on Day 13 or on Day 8.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1369731|NCT01570192|Secondary|Mortality|Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)|28 days|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369732|NCT01570192|Secondary|Mortality|Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)|14 days|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369733|NCT01570192|Secondary|Occurrence of Repeat Negative Cultures|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|Day 5/Early Extubation|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369734|NCT01570192|Secondary|Suppression of the Emergence of Resistance in Other Gram-negative Pathogens|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|Day 5/Early Extubation|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369735|NCT01570192|Secondary|Pretreatment Pathogen Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369736|NCT01570192|Secondary|Overall Microbiologic Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369737|NCT01570192|Secondary|Clinical Response in Subjects Who Received Prior Antibiotics|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369738|NCT01570192|Secondary|Clinical Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
1369739|NCT01570192|Primary|Number of Participants With Suppression and Emergence of Resistance|The emergence of resistance is defined as a change of meropenem MIC or aminoglycoside MIC by two tube dilutions (fourfold) from baseline when assessed at the second BAL procedure on day 5/early extubation. Patients are evaluable for this endpoint IF they had baseline BAL and Day 5/early extubation and if they had positive cultures on baseline and Day/EE.|up to 28 days after enrollment|All patients in the ME population with BAL at baseline and at Day 5/EE and pathogens collected at baseline BAL and at Day 5/EE BAL.|||participants|||Number
1369740|NCT01569841|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Hypoglycemic episodes reported within each 6 week treatment period.|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1369741|NCT01569841|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Within each week 6 treatment period|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1372664|NCT01536405|Secondary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1369744|NCT01569841|Secondary|Mean Interstitial Glucose (IG) Based on 14 Days of CGM|The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.|CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||mmol/L||Standard Deviation|Mean
1369745|NCT01569841|Primary|Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)|Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.|CGM occured during the last 2 weeks of the 6 weeks treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||hours||Standard Deviation|Mean
1369746|NCT01569828|Primary|CLr After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set|||(ml/hr)||Standard Deviation|Mean
1369747|NCT01569828|Primary|CL/F After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set|||(ml/hr)||Standard Deviation|Mean
1369748|NCT01569828|Primary|T1/2 After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set|||(hr)||Standard Deviation|Mean
1369749|NCT01569828|Primary|AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set|||(hr*ng/mL)||Standard Deviation|Mean
1369750|NCT01569828|Primary|(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set|||ng/mL||Standard Deviation|Mean
1369751|NCT01569828|Secondary|24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers||5 days||||mmol/day||Standard Deviation|Mean
1369752|NCT01569828|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set|||hour||Full Range|Median
1369753|NCT01569815|Secondary|Change in Mean 24-hours Sodium Clearance From Baseline to Day 7|Sodium clearance will be measured in urine from baseline until Day 7|From baseline to Day 7|FAS|||mmol/day||Standard Deviation|Mean
1369754|NCT01569815|Primary|Amount of Drug Excreted Into the Urine From Time Zero to 24-hours Post-dose (Ae0-24) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and Day 5||||ug||Standard Deviation|Mean
1369755|NCT01569815|Primary|Renal Clearance From Plasma (CLr) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS|||mL/hr||Standard Deviation|Mean
1369756|NCT01569815|Primary|Accumulation Ratio (Racc) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS|||Ratio (AUC0-24, day 5)/(AUC0-24, day 1)||Standard Deviation|Mean
1369757|NCT01569815|Primary|Systemic Clearance From Plasma Following Extravascular Administration (CL/F) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5||||mL/hr||Standard Deviation|Mean
1369758|NCT01569815|Primary|Elimination Half-life (t1/2) After Multiple Dose (Day 5) Administration|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS|||hr||Standard Deviation|Mean
1369759|NCT01569815|Primary|Area Under the Concentration-time Curve (AUC0-24) From Time Zero to 24- Hour Post-dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5|FAS|||ng*hr/mL||Standard Deviation|Mean
1369760|NCT01569815|Primary|Maximum Peak Plasma Concentration (Cmax) Observed After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1, day 5||||ng/mL||Standard Deviation|Mean
1369761|NCT01569815|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5||||hr||Full Range|Median
1369762|NCT01569763|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Randomized subjects|||participants|||Number
1369763|NCT01569763|Secondary|Procedure Time|Procedure time is defined as the time from device insertion to time of device removal.|< 1 hour|Subjects completing treatment|||Minutes||Standard Deviation|Mean
1369764|NCT01569763|Primary|Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months|Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.|12 months|All Randomized subjects in whom treatment was attempted|||participants|||Number
1369765|NCT01569607|Secondary|Mean Wolf Motor Function Test (WMFT) Grip Strength|Participants attempt to grip the dynamometer with greatest grip strength possible. The test should be conducted 3 times with a 1-minute rest between trials. The mean of grip strength exerted (kg) on 3 trials is then calculated.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||kilograms||Standard Deviation|Mean
1369766|NCT01569607|Secondary|Mean Wolf Motor Function Test Functional Ability (WMFT-FS) Scale Score|The WMFT is a 17 item scale that quantifies upper extremity (UE) motor ability through timed and functional tasks. The items are rated on a 6-point scale.Total scores can range from 17 to 102. Lower scores indicate debilitating mobility (such as no or limited functionality), while higher score indicate greater mobility (such as slow movement and normal movement).|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|One participant from both arms was removed from the data analysis due to errors in data collection yielding uninterpretable results.|||units on a scale||Standard Deviation|Mean
1369767|NCT01569607|Secondary|Mean Wolf Motor Function Test (WMFT) Total Time|The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. There are 15 timed tasks included with a time cap of 120 seconds. The max amount of time to completion is 1800 seconds if all tasks are failed. The time in seconds were summed across all the tasks to obtain the total duration. Values in the table represent the time taken in seconds to successfully complete all 15 tasks).|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||seconds||Standard Deviation|Mean
1369768|NCT01569607|Secondary|Mean Motor Activity Log (MAL): How Well Subtest|"Individuals are asked to rate quality of movement during 30 daily functional tasks. Items are scored on a 6-point ordinal scale as follows:~0=The weaker arm was not used at all for that activity (never); 1=The weaker arm was moved during that activity, but was not helpful (very poor); 2=The weaker arm was of some use during the activity, but needed help from the stronger arm or moved very slowly or with difficulty (poor); 3=The weaker arm was used for the purpose indicated, but movements were slow or were made with only some effort (fair); 4=The movements made by the weaker arm were almost normal, but were not quite as fast or accurate as normal (almost normal); 5=The ability to use the weaker arm for that activity was as good as before the stroke (normal)~Total scores range from 0 to 140; 0 indicating the least movement and 140 indicating the most movement."|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||units on a scale||Standard Deviation|Mean
1369769|NCT01569607|Secondary|Mean Motor Activity Log (MAL) Score: Amount Subtest|"Individuals are asked to rate amount of movement during 30 daily functional tasks. Items are scored on a 0 to 6-point ordinal scale as follows:~0 = The weaker arm was not used at all for that activity (never)~1 = Occasionally used weaker arm, but only very rarely (very rarely)~2= Sometimes used weaker arm, but did the activity most of the time with stronger arm (rarely)~3 = Used weaker arm about half as much as before the stroke (half pre-stroke)~4 = Used weaker arm almost as much as before the stroke (3/4 pre-stroke)~5 = The ability to use the weaker arm for that activity was as good as before the stroke (normal)~Total scores range from 0 to 140; 0 indicating the least movement 140 indicating the most movement. The scores were converted into percentage scores where higher percent score indicate more movement and lower percent score less movement."|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||units on a scale||Standard Deviation|Mean
1369770|NCT01569607|Secondary|Mean Reaction Time of Wrist Extension Movements|Subjects will be asked to perform 7 auditory-cued ballistic wrist extensions before and after motor training. Electromyographic (EMG) activity recorded during the ballistic wrist extensions will be used to measure reaction time. Reaction time is the length of time between the auditory cue and the onset of the movement-related EMG burst of the extensor carpi ulnaris muscle. A longer time indicated longer time to reaction.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Three participants from both arms were removed from the data analysis due to errors in data collection yielding uninterpretable results.|||milliseconds||Standard Deviation|Mean
1369771|NCT01569607|Secondary|Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured at baseline, one week after the treatment (post-training 1), and four weeks after the treatment (post-training 2). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Three participants from both arms were removed from the data analysis due to errors in data collection yielding uninterpretable results.|||g||Standard Deviation|Mean
1369772|NCT01569607|Secondary|Mean Time to Completion for Jebsen Hand Function Test (JTT)|The JTT provides a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living assessing the speed of performance. Total score is the sum of time taken for each sub-test, which were normalized to standard scores (also expressed in seconds).Total scores range from +1 to -1 where -1 indicates best function.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||units on a scale||Standard Deviation|Mean
1369773|NCT01569607|Primary|Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), one week after the treatment (post-training 1), and 4 weeks after treatment (post-training 2).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1 (1 Week), Post-Training 2 (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||millivolts||Standard Deviation|Mean
1369774|NCT01569568|Secondary|Neuropsychological Assessment|Testing consisted of the Wechsler Abbreviated Scale of Intelligence (WASI), Comprehensive Trail Making Test (CTMT) (range 17-87), and the Behavioral Rating Inventory of Executive Function (BRIEF) (range GEC: 70-210; BRI:39-82 ; MI:41-92). The WASI includes three measures of intelligence; including, performance IQ (sum of block design and matrices sub scales; range: 40-160), verbal IQ (sum of vocabulary and similarities sub scales; range 40-160), and total IQ (sum of all four subscales; range: 80-320). The CTMT measures simple attention and executive function, it consists of five dot to dots that increase with complexity and difficulty. Higher values indicate better outcomes for all scales.|Baseline||||units on a scale||Standard Deviation|Mean
1370776|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 48 Hours|Pharmacodynamic Population Set|||ratio||95% Confidence Interval|Least Squares Mean
1369775|NCT01569568|Primary|Fractional Anisotropy Assessed Using DTI|Fractional Anisotropy (FA) is a measure of the diffusion asymmetry within a voxel as defined by its eigenvalues. In our study, FA is being used as a measure of white matter integrity, because FA is very sensitive to small microstructural changes.Fractional anisotropy (FA) is a scalar value between zero and one (0-1) that describe anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions.|Baseline||||units on a scale||Standard Deviation|Mean
1369776|NCT01569568|Primary|Functional Connectivity of Assessed by Resting-state fMRI|Investigation of differences in functional connectivity of OTCD patients compared to healthy controls, particularly in the default-mode network (DMN) and the set-maintenance network (SMN). Participants underwent a resting-state scan using 3T fMRI. Combining independent component analysis (ICA) and region-of-interest (ROI) analyses, identified the nodes that comprised each network in each group, and assessed internodal connectivity. For each subject, this analysis generated a correlation value, which reflected the strength of functional connectivity between each ROI pair.The correlation r-values were normalized using Fisher’s r-to-Z-transform, generating z-scores. The DMN was composed of 1) anterior cingulate/medial prefrontal cortex (ACC/mPFC), 2) posterior cingulate cortex (PCC), and 3) bilateral inferior parietal lobule (IPL). The SMN was composed of 1)ACC, 2) bilateral superior frontal gyrus (SFG), and 3) bilateral anterior insula/frontal operculum (aI/fO).|Baseline|Resting state data was not acquired for several of our participants (7 controls and 4 patients). Furthermore, 3 OTCD patients were excluded from the analyses due to excessive head motion.|||z-scores||Standard Deviation|Mean
1369777|NCT01569568|Primary|Concentration of Glutamine and Myoinositol|"Concentration based on area under curve on 1H Magnetic Resonance Spectroscopy(MRS) and quantitated by LCModel (a method that allows automatic quantitation of spectroscopy data). A metabolite's tissue concentration is related to the integrated amplitude, the area under the curve of the MRS signal, it produces. While MRS signals are usually acquired in the time domain as free induction decays or echoes, they are usually viewed and analyzed in the frequency domain. The frequency domain representation is derived from the acquired time domain data by the Fourier Transform. The protocol we use selects 257 averages. The machine summates the data at each time point to generate one value for the area under the curve. Therefore, we don't have the measurement at each time point.~Furthermore, we measured voxels in two different brain areas containing different kinds of brain matter: one voxel was located in posterior cingulate gray matter (PCGM) and the other in parietal white matter (PWM)."|Baseline|Two OTCD patients and one healthy control were excluded due to excessive head motion.|||mM||Standard Deviation|Mean
1369778|NCT01569529|Primary|Program Enrollment|Rates of enrollment will be calculated as the proportion of visitors who enroll in treatment (e.g., number of enrollments/number of click-throughs from banner ads).|1-month intervals over 7 months||||proportion of click-throughs who enroll|Click-through from advertisements||Number
1369779|NCT01569464|Secondary|Change From Baseline in SF-36 Physical Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).~The SF–36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369780|NCT01569464|Secondary|Change From Baseline in SF-36 Mental Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).~The SF–36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369781|NCT01569464|Secondary|Change In Total Score From Baseline To The End of Maintenance Period On Profile Of Mood States Questionnaire (POMS)|"The Profile of Mood States questionnaire (POMS) total score will be calculated as the sum of the scores for the following 5 scale scores (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Fatigue-Inertia, and Confusion-Bewilderment) and then subtracting the Vigor-Activity score. All factors have to be available for the total score to be calculated; otherwise the total score will be set to missing. The range for the POMS is 0 - 200 with a high score being negative and a low score being positive.~For the POMS questionnaire total score, descriptive statistics will be presented on both the observed and the change from Baseline to the end of the Maintenance Period values for the Full Analysis Set (FAS)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369798|NCT01569451|Secondary|Change From Baseline to 24 Months on the Multiple Sclerosis Functional Composite (MSFC) Z-score|The MSFC consists of Timed 25 Foot Walk Tests, 9 Hole Peg Tests, and the Paced Auditory Serial Addition Test (PASAT), administered by clinicians. The subscales are then converted into Z-scores and averaged to create the MSFC Z-score. Larger values denote improvements.|Observations were recorded at baseline and 24 months.||||units on a scale (MSFC Z score)||95% Confidence Interval|Mean
1369782|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Quantity Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (Sleep Scale-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369783|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Adequacy Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369784|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Disturbance Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369785|NCT01569464|Secondary|Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep–R)|"The Medical Outcomes Study (MOS) Sleep Scale–Revised (MOS Sleep–R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep–R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from “all of the time” to “none of the time”. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369786|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = not at all) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369787|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1373645|NCT01525407|Secondary|Disease-free Survival|Evaluated as Kaplan-Meier estimate in the patients/recipients.|1 year after transplant||||disease free survival probability||95% Confidence Interval|Number
1369788|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369789|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369790|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369791|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = completely satisfied) to (10 = completely dissatisfied).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369792|NCT01569464|Secondary|Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT)|"During each single Suggested Immobilization Test (SIT) PLMWI was measured using a validated actigraphy device. Simultaneous actigraphy of the legs was performed by an actigraphy device, which was attached to the ankle prior to the start of the SIT. The PLMWI was recorded while the subject was awake.~Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 149 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369793|NCT01569464|Primary|Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT)|"The Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) was used for assessment of the sensory components of Restless Legs Syndrome (RLS) symptoms in order to provide a subjective score of the severity of RLS symptoms during each Suggested Immobilization Test (SIT).~Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369794|NCT01569464|Primary|Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score|"The International Restless Legs Scale (IRLS) was intended to evaluate, in a standardized way, the subjective intensity of major symptoms of Restless Legs Syndrome (RLS) and, in 2 items (9 and 10), the impact of the disease on subjects functioning in daytime activities by use of a 5-point scale for each of a total of 10 items.~In all items, the scores ranged from 0 (not present) to 4 (severe). A sum score across all 10 items was calculated for analysis, which varied between 0 (no RLS symptoms present at all) to 40 (maximum severity in all symptoms)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
1369795|NCT01569451|Post-Hoc|Exposure Time|Values represent mean duration of treatment.|Measured in three month intervals from baseline to end of study.||||years||Standard Deviation|Mean
1369796|NCT01569451|Secondary|Change in Mean Score on Performance Scales (Baseline to 24 Months)|Performance scales measures patient assessments of disability in mobility (1-6), hand (1-5), vision (1-5), fatigue (1-5), cognitive (1-5), bladder and bowel, sensory (1-5), and spasticity (1-5). The overall measure of performance is the sum of subscales, ranging from 0 to 41. Larger numbers mean more disability, with 0 being no disability and the maximum number being total disability.|Baseline through 24 months|At 24 months (2 years); the end of the study follow up period compared with baseline.|||units on a scale||95% Confidence Interval|Mean
1369797|NCT01569451|Secondary|Percentage of Subjects Worsening One Point or More on the Patient Determined Disease Steps (PDDS) Questionnaire|For PDDS the patient selects an integer 0-8 according to their personal assessment of their degree of ambulatory disability. Larger numbers mean more disability, with 0 being no disability and 8 being bedridden. There is an unclassifiable category as well.|Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||Participants|||Count of Participants
1375075|NCT01509040|Secondary|Use of Pressors and Inotropes|This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.|48 hours||||participants|||Number
1369799|NCT01569451|Secondary|Number of Patients That Develop Sustained Accumulation of Disability|Sustained accumulation of disability is defined as a 1 point change or more on the Expanded Disability Status Scale (EDSS); sustained for at least three months. Physicians assess patients' cerebral, optic, brainstem, pyramidal, sensory, cerebellar, and bowel and bladder neurological symptoms. The physician then subjectively rates the patient on the ordinal EDSS scale. The EDSS scale emphasizes ambulatory ability. The EDSS scale ranges in half integer increments from 0.0 to 10.0. Larger numbers mean more disability, with 0.0 being everything normal and 10.0 being death due to MS.|Baseline through 24 months|At any observation within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
1369800|NCT01569451|Secondary|Number of Subjects Who Experience Multiple Relapses||Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
1369801|NCT01569451|Secondary|Number of Patients Treated for Relapse With Corticosteroid||Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
1369802|NCT01569451|Secondary|Number of Relapse-free Subjects|Change in neurological symptoms in association with EDSS change is defined as relapse.|Baseline through 24 months|Out to the last observation for each patient within 24 months (2 years) of follow up.|||participants|||Number
1369803|NCT01569451|Secondary|Number of Subjects That Fail Treatment||Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
1369804|NCT01569451|Secondary|Time to Treatment Failure|Time itself is the outcome. Whenever treatment failure occurs for the first time within the follow up period of 24 months (2 years).|Baseline through 24 months|Time itself is the outcome. Whenever treatment failure occurs for the first time within the follow up period of 24 months (2 years). Exposure time varies by patient. See exposure time outcome (post hoc).|||months||95% Confidence Interval|Median
1369805|NCT01569451|Primary|Number of Disease-free Patients|Defined as patients without new lesions on brain MRI using the combined unique lesion approach (CUL), without sustained change in EDSS score over any 3-month period and without relapse. If a clear treatment effect is sustained in the R-GA arm, defined as a ≥ 70% decrease in brain lesions on MRI, using a CUL approach, attributable to MS and ≥ 70% reduction in annual relapse rates, compared to the GA arm, the study will continue under the extension protocol. If induction therapy fails to show superiority, at any point, the study will be stopped.|Baseline through 24 months|Out to the last observation for each patient within 24 months (2 years) of follow up.|||participants|||Number
1369806|NCT01569438|Secondary|Genitourinary Pain Index (GUPI)|The GUPI is an instrument that is used to assess the degree of symptoms in women with genitourinary pain complaints. The sum of the items yields three subscales and a total score. The subscales are pain (0-23), urinary (0-10), and quality of life (0-12). The sum of the subscales is the total score (0-45). Higher scores indicate more severe symptoms.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
1369807|NCT01569438|Secondary|O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)|The ICSI contains 4 items that measured how problematic symptoms were for subjects with bladder pain syndrome. Each question in the ICPI was on a scale of 0-4, where each answer was given a specific rating. The sum of the item scores indicated more problematic symptoms. The index score ranged from 0-16 where higher scores indicated more problematic symptoms.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
1369808|NCT01569438|Secondary|Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD)|The PBIC-SD was an 8-item subject self-report measure for assessing the severity of bladder pain syndrome. All items were graded on a scale from 0 (good condition) to 4 (poor condition) for a total score between 0 and 32.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
1369809|NCT01569438|Primary|The Primary Efficacy Endpoint of This Study is Change in the 'Average Pain' NPRS Score.|Subjects were instructed to select a number on a scale that best described the severity of bladder pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst pain possible. The scale was completed by telephone (an interactive voice response system[IVRS]) every evening at bedtime.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
1369810|NCT01569295|Secondary|Complete Response Rate|Complete response (CR) rate was defined as the percentage of participants who achieved a CR.|Up to 40 months|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1369811|NCT01569295|Secondary|Overall Survival|Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.|Up to 47 months|ITT Analysis Set|||months||95% Confidence Interval|Median
1369812|NCT01569295|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.|Up to 45 months|ITT Analysis Set|||percentage of particpants||95% Confidence Interval|Number
1369832|NCT01569152|Secondary|DAS28-CRP Area Under the Curve (AUC)|DAS28-CRP AUC was to be calculated from the DAS28-CRP score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-CRP AUC was to be calculated using the trapezoidal rule as the DAS28-CRP multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.|Up to 12 weeks|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1369813|NCT01569295|Secondary|Overall Response Rate (ORR)|"ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.~PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow."|Up to 45 months|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1369814|NCT01569295|Primary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375|Up to 45 months|ITT Analysis Set|||months||95% Confidence Interval|Median
1369815|NCT01569191|Primary|Ocular Temperature|Ocular surface temperature will be measured with an infra-red camera|1 hour||||degrees centrigrade||Standard Deviation|Mean
1369816|NCT01569191|Primary|Ocular Redness|"Bulbar and limbal redness will be observed with a slit lamp biomicroscope and graded using a validated scale~• The 'Efron' grading scale consists of 5 pictures of eyes of increasing severity of blood vessels over the white of the eye, with the clinician selecting the image closest to what they observe on the patient (0 indicating a white eye and 4 a very irritated eye). There are no subscales"|1 hour||||units on a scale||Standard Deviation|Mean
1369817|NCT01569191|Primary|Symptoms|Short questionnaire Ocular allergy symptomology was also measured using the eye symptom section from the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) on a 0 to 6 scale, with the summed score for itching, watering, swelling and soreness resulting in a summed score between 0 and 24. A higher score indicates a worse outcome (more severe symptoms)|1 hour||||Units on a scale||Standard Deviation|Mean
1369818|NCT01569152|Secondary|Percentage of Participants With an ACR20 Response Over Time|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 1, Week 2, Week 4, Week 6, Week 18 and Week 24|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR20 measurement|||Percentage of participants|||Number
1369819|NCT01569152|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR50 assessment|||Percentage of participants|||Number
1369820|NCT01569152|Secondary|Change From Baseline in Hemoglobin at Week 12|Hemoglobin is the iron-containing oxygen-transport metalloprotein in red blood cells. Change from Baseline is hemoglobin at Week 12 minus hemoglobin at Baseline. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had non-missing Baseline and Week 12 hemoglobin values|||gm/dL||Standard Deviation|Mean
1369821|NCT01569152|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12|The ESR is the rate at which red blood cells sediment in a period of one hour, and is a non-specific measure of inflammation. Change from Baseline is ESR at Week 12 minus ESR at Baseline. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ESR assessment|||mm/hr||95% Confidence Interval|Least Squares Mean
1369822|NCT01569152|Secondary|Change From Baseline in Serum C-Reactive Protein (CRP) at Week 12|C-Reactive Protein is an inflammatory marker with a normal reference range of less than 0.9 mg/dL. Change from Baseline in CRP at Week 12 (Week 12 concentration minus Baseline concentration). This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline serum CRP assessment|||mg/dL||95% Confidence Interval|Least Squares Mean
1369833|NCT01569152|Secondary|DAS28-ESR Area Under the Curve (AUC)|DAS28-ESR AUC was to be calculated from the DAS28-ESR score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-ESR AUC was to be calculated using the trapezoidal rule as the DAS28-ESR multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.|Up to 12 weeks|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1372665|NCT01536405|Primary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 5 days after vaccination 1|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1369823|NCT01569152|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline HAQ Disability Index assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
1369824|NCT01569152|Secondary|Change From Baseline in the Patient's Global Assessment of Pain (PGAP) at Week 12|A participant’s overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS where 0 mm = “no pain” and 100 mm = “extreme pain”. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline PGAP assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
1369825|NCT01569152|Secondary|Change From Baseline in the Investigator's Global Assessment of Disease Status/Activity (IGADSA) at Week 12|The Investigator's Global Assessment of Disease Status/Activity (IGADSA) is measured with scores ranging from 0 to 100 mm (VAS, 0 mm = doing very well to 100 mm = doing very poor). A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline IGADSA assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
1369826|NCT01569152|Secondary|Change From Baseline in the Patient's Global Assessment of Disease Status/Activity (PGADSA) at Week 12|A participant’s overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS, where 0 mm = doing very well to 100 mm = doing very poor. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline PGADSA assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
1369827|NCT01569152|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12|The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). The higher the participant's response to the questions the greater the participant's fatigue. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1369828|NCT01569152|Secondary|Change From Baseline in the Short Form Health Survey (SF-36) at Week 12|The SF-36 is a health-related quality of life instrument that consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. The lower the score the greater the disability i.e., a score of 0 corresponds to maximum disability and a score of 100 corresponds to no disability. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1369829|NCT01569152|Secondary|Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12|SDAI is the simple linear sum of the following parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, Patient's Global Assessment of Disease Activity [PGA, VAS 0 to 10 cm], Investigator's Global Assessment of Disease Activity (MDGA, VAS 0 to 10 cm) and CRP levels (mg/dL). SDAI =TJC + SJC + PGA + MDGA + CRP. Overall scores can range from 0.0 to 86.0. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline SDAI assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
1369830|NCT01569152|Secondary|Change From Baseline in Swollen Joint Count at Week 12|Swollen joint count included 66 joints (same joints as for tender joint count except this excluded evaluation of hips) that were assessed for the presence of swelling. Soft tissue swelling was considered to be present if there was palpable or visible evidence of capsular distention considered to be due to either synovial thickening and/or a joint effusion. Bony swelling, nodule formation, and joint deformity were excluded from consideration. A swollen joint was scored as 0 = Absent; 1 = Present for each joint. The overall swollen joint count ranged from 0 to 66. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline swollen joint count|||Swollen joints||95% Confidence Interval|Least Squares Mean
1369831|NCT01569152|Secondary|Change From Baseline in Tender Joint Count at Week 12|Tender Joint Count was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline tender joint count|||Tender joints||95% Confidence Interval|Least Squares Mean
1369834|NCT01569152|Secondary|Percentage of Participants Achieving DAS28-CRP Remission at Week 12|The DAS28-CRP is a continuous parameter derived from the formula: 0.56 × the square root of the tender joint count (0-28) + 0.28 × the square root of the swelling joint count (0-28) + 0.36 × the C reactive protein value (in mg/L +1) + 0.014 × Patient’s Global Assessment of Disease Activity VAS of 0-100 mm + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-CRP remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-CRP measurement|||Percentage of participants|||Number
1369835|NCT01569152|Secondary|Percentage of Participants Achieving DAS28-ESR Remission at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-ESR remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-ESR measurement|||Percentage of participants|||Number
1369836|NCT01569152|Secondary|Percentage of Participants Achieving a DAS28-CRP Response at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-CRP value for a given visit, change in DAS28-CRP is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-CRP was reported. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-CRP measurement|||Percentage of participants|||Number
1369837|NCT01569152|Secondary|Percentage of Participants Achieving a DAS28-ESR Response at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-ESR value for a given visit, change in DAS28-ESR is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-ESR was reported. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-ESR measurement|||Percentage of participants|||Number
1369838|NCT01569152|Secondary|Percentage of Participants Achieving an ACR-N Response at Week 12|The ACR-N response is the minimum of the following: 1) the percent decrease from Baseline in tender joint counts (68 joints, 0 = absent, 1 = present); 2) the percent decrease from Baseline in swollen joint counts (66 joints, 0 = absent, 1 = present); and 3) the median percent decrease from Baseline for the following: a) Patient’s Global Assessment of Pain (VAS, 0 mm = “no pain” and 100 mm = “extreme pain”); b) Patient’s Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); c) Investigator’s Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); d. physical function as measured by the HAQ (Likert scale, 0 to 3 with a lower score indicating less disability); and e) CRP. This outcome measure applied to Base Study participants only.|Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1369839|NCT01569152|Secondary|Percentage of Participants Achieving Hybrid ACR Response at Week 12|Hybrid ACR Response evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a categorical score of the mean change in the core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP). The mean percentage improvement from Baseline in the core set measures was computed and used with the participant's ACR20, ACR50, and ACR70 status to determine the hybrid ACR response in a lookup table. The range of values was -100 to 100, with a positive change indicating improvement. This outcome measure applied to Base Study participants only.|Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
1369840|NCT01569152|Secondary|Percentage of Participants Achieving an ACR70 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR70 response is defined as a ≥70% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥70% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR70 measurement|||Percentage of participants|||Number
1369924|NCT01568424|Secondary|Mean Arterial Pressure (MAP)|MAP is the mean value for the blood pressure in the arterial circulation. During RVAD support, this value provides information regarding the adequacy of cardiac output from the left ventricle.|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.|Patients with continuous RVAD support.|||mmHg||Full Range|Median
1369841|NCT01569152|Secondary|Change From Baseline in DAS28 as Measured by C-Reactive Protein (CRP) at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had both Baseline and Week 12 DAS28-CRP measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
1369842|NCT01569152|Secondary|Change From Baseline in Disease Activity Score (DAS28) as Measured by Erythrocyte Sedimentation Rate (ESR) at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater rheumatoid arthritis (RA) disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had both Baseline and Week 12 DAS28-ESR measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
1369843|NCT01569152|Primary|Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant’s overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator’s Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant’s assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR20 measurement (last observation carried forward)|||Percentage of participants|||Number
1369844|NCT01569126|Secondary|Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals|The number of participants with a maximum increase from baseline in 12-lead electrocardiogram (ECG) QTcB and QTcF intervals >30 milliseconds (ms) and >60 ms for the single-dose (SD) and multiple-dose (MD) periods is reported.|Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period)|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||participants|||Number
1369845|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(tau,steady state) of plasma total fluoxetine and norfluoxetine during the MD period is reported.|Predose up to Day 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1369846|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-24) of plasma total fluoxetine and norfluoxetine on Day 1 of the MD period is reported.|Day 1|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1369847|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine on Day 1 and Day 28 of the MD period is reported.|Days 1 and 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1369848|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-infinity) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1369849|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-tlast) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1369850|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1369851|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 70|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug or placebo and had at least 1 postdose safety assessment.|||participants|||Number
1369852|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||participants|||Number
1369853|NCT01569087|Secondary|Incidence of Febrile Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||participants|||Number
1369854|NCT01569087|Secondary|Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||days||Standard Deviation|Mean
1369855|NCT01569087|Secondary|Low Level (Nadir) ANC x 10^9/L||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||cells x 10^9/L||Inter-Quartile Range|Median
1369856|NCT01569087|Secondary|The Duration of Any Grade Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||days||Standard Deviation|Mean
1369857|NCT01569087|Secondary|Mean Duration of CTCAE Grade 4 Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||days||Standard Deviation|Mean
1369858|NCT01569087|Primary|CTCAE Grade 3/4 Neutropenia Incidence||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||participants|||Number
1369859|NCT01569074|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1369860|NCT01569074|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1369861|NCT01569074|Secondary|Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1369862|NCT01569074|Secondary|Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 12 was derived and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice a day, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1369863|NCT01569074|Secondary|Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient’s own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, , DMARD = disease modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1369864|NCT01569074|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 12|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient’s own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 12. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
1369865|NCT01569074|Secondary|Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1369866|NCT01569074|Secondary|Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1369867|NCT01569074|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The fostamatinib 100 mg BID combined group contains 31 patients from Dosing Group A and 33 patients from Dosing Group B.|||Percentage of responders|||Number
1369868|NCT01569074|Primary|Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1369869|NCT01569022|Secondary|Adherence to Therapy|comparison of the number of hours per night used while on CPAP versus MAD|12 weeks||||hours per night||Standard Deviation|Mean
1369870|NCT01569022|Secondary|General Health SF-36|The SF-36 is a generic 36-item Short Form Medical Outcomes Survey (SF-36) 16. It has eight main domains: physical functioning, role limitation due to physical problems, role limitation due to emotional problems, social functioning, mental health, energy/vitality, bodily pain, and general health perception. General Health SF36 score is coded, summed, and transformed onto a scale from 0 to 100 (worst to best possible health).|12 weeks||||units on a scale||Standard Deviation|Mean
1369871|NCT01569022|Secondary|Health Outcomes|Health outcomes including ESS, PCL-M, and PSQI. ESS is a short questionnaire validated to measure excessive daytime sleepiness in patients with OSA 17. It measures the likelihood of falling asleep in eight different situations, with a score of 0-3 for each situation. The sum of individual scores for the eight items gives the final ESS score, ranging from 0-21. An ESS score >10 suggests excessive daytime sleepiness (EDS). The PSQI is a self-rating questionnaire that consists of seven dimensions. The possible scores range from 0–21, with greater than five indicative of impaired sleep quality. The PTSD Checklist is a 17-item self-report measure (1-5 points each) that assesses PTSD symptoms in relation to stressful military experiences. PTSD symptom severity scores are determined by summing the participants’ answers to all 17 items from 1 (“not at all”) to 5 (“extremely”)(range 17-85) 14 with 5-10 point change indicating statistically significant response to treatment|12 weeks||||units on a scale||Standard Deviation|Mean
1369872|NCT01569022|Primary|Residual Apnea Hypopnea Index|The primary endpoint of the study was tested by comparing the upper limit of the 95% confidence interval for the CPAP-MAD difference in residual AHI with the a priori noninferiority margin using the paired t test|up to 12 weeks||||events per hour||Standard Deviation|Mean
1369873|NCT01568905|Secondary|Comparison of Number of Cigarettes Smoked|Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.|1 week||||cigarettes per week||Standard Deviation|Mean
1369874|NCT01568905|Secondary|Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes|Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.|Baseline (Day 1) Compared to Second Visit (Week 1)||||units on a scale||Standard Error|Mean
1369875|NCT01568905|Secondary|Responses on Modified Cigarette Evaluation Scale|Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.|Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)||||units on a scale||Standard Error|Mean
1369876|NCT01568905|Primary|Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1|Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.|Second Visit (Week 1) minus Baseline (Day 1)||||nmols/ml||Standard Error|Mean
1369877|NCT01568892|Secondary|Change From Baseline in Red Blood Cell Count|Blood samples were collected for the analysis of hematology parameters such as RBC. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Trillion cells per liter||Standard Deviation|Mean
1369878|NCT01568892|Secondary|Change From Baseline in Mean Corpuscle Volume|Blood samples were collected for the analysis of hematology parameters such as mean corpuscle volume. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Femtoliter||Standard Deviation|Mean
1369879|NCT01568892|Secondary|Change From Baseline in Hematocrit Level|Blood samples were collected for the analysis of hematology parameters such as hematocrit level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Proportion of red blood cells in blood||Standard Deviation|Mean
1369880|NCT01568892|Secondary|Change From Baseline in Hemoglobin Level|Blood samples were collected for the analysis of hematology parameters such as hemoglobin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||Grams per liter||Standard Deviation|Mean
1369881|NCT01568892|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count|Blood samples were collected for the analysis of hematology parameters such as basophils, eosinophils. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Giga cells per liter||Standard Deviation|Mean
1369882|NCT01568892|Secondary|Change From Baseline in Lipase Levels|Blood samples were collected for the analysis of clinical chemistry parameters such as lipase level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||Units per liter||Standard Deviation|Mean
1369883|NCT01568892|Secondary|Change From Baseline in Creatinine Clearance|Creatinine clearance was calculated using Cockcroft-Gault formula. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline, Day 8, Day 28, Week 8, Week 16, Week 24, Week 32 and Week 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Milliliters per minute||Standard Deviation|Mean
1369884|NCT01568892|Secondary|Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen|Blood samples were collected for the analysis of clinical chemistry parameters such as cholesterol, chloride, CO2/HCO3, glucose, high density lipoprotein (HDL) cholesterol, potassium, LDL cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN). Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Lipid and glucose parameters were only summarized on fasting data. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Millimoles per liter||Standard Deviation|Mean
1369885|NCT01568892|Secondary|Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels|Blood samples were collected for the analysis of clinical chemistry parameters such as T. Bil and creatinine. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Micromoles per liter||Standard Deviation|Mean
1369886|NCT01568892|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase|Blood samples were collected for the analysis of clinical chemistry parameters such as ALP, ALT, AST and creatine kinase. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||International units per liter||Standard Deviation|Mean
1369887|NCT01568892|Secondary|Change From Baseline in Albumin Level|Blood samples were collected for the analysis of clinical chemistry parameters such as albumin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline, Week 24 and 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||grams per liter||Standard Deviation|Mean
1369888|NCT01568892|Secondary|Change From Baseline in Heart Rate|Vital signs including heart rate was measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline and Weeks 24 and 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||beats per minute||Standard Deviation|Mean
1369889|NCT01568892|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs including SBP and DBP were measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline and Weeks 24 and 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||millimeters of mercury||Standard Deviation|Mean
1369890|NCT01568892|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Twelve lead ECG was performed using an automated ECG machine. The number of participants with abnormal-clinically significant ECG findings at any time on-treatment is reported.|Up to Week 24|Safety Population. Only those participants with data available at the specified time point was analyzed.|||Participants|||Count of Participants
1369891|NCT01568892|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs|The number of participants who permanently discontinued study treatment due to AEs is presented.|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population|||Participants|||Count of Participants
1369892|NCT01568892|Secondary|Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.|||Participants|||Count of Participants
1369893|NCT01568892|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.|||Participants|||Count of Participants
1369894|NCT01568892|Secondary|Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24|Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24.|Day 8, Day 28, and Week 24|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1369925|NCT01568424|Secondary|Central Venous Pressure (CVP)|CVP is a measure of right heart filling pressure, or the preload to the right ventricle. During RVAD support, the CVP decreases as blood is drawn into the pump and then ejected into the pulmonary artery.|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal|Patients with continuous RVAD support.|||mmHg||Full Range|Median
1369895|NCT01568892|Secondary|Cmax of DTG|The maximal concentration (Cmax) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.|Day 8, Day 28, and Week 24|PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1369896|NCT01568892|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.|Day 8, Day 28, and Week 24|PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.|||µg*hour per mL (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1369897|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population|||Participants|||Count of Participants
1369898|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population|||Participants|||Count of Participants
1369899|NCT01568892|Secondary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population: all randomized participants who received at least one dose of study medication|||Participants|||Count of Participants
1369900|NCT01568892|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until early withdrawal or the Week 48 analysis cut-off date (median of 55 study weeks)|ITT-E Population|||Participants|||Count of Participants
1369901|NCT01568892|Secondary|Median Change From Baseline in CD8+ Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline; Day 28; Weeks 12, 24, and 48|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per cubic millimeter||Inter-Quartile Range|Median
1369902|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48.|Baseline; Day 28; Weeks 12, 24, and 48|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per cubic millimeter||Inter-Quartile Range|Median
1369903|NCT01568892|Secondary|Median Change From Baseline in CD4+ Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. Observed dataset was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per cubic millimeters||Inter-Quartile Range|Median
1369979|NCT01567943|Primary|Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine|Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.|Over 16 weeks of treatment (repeated measure)||||EtG Value (nanograms per milileter)||Standard Error|Mean
1369904|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||Cells per cubic millimeters||Inter-Quartile Range|Median
1369905|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48. Number of participants with plasma HIV-1 RNA level <400 c/mL was obtained using FDA’s snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switch their concomitant ART prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however the decision to switch is not documented as being before or at the first On-treatment visit after switching to OBR (i.e. Day 28) where HIV-1 RNA is assessed.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48|ITT-E Population. The Snapshot dataset was used for analysis.|||Participants|||Count of Participants
1369906|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, and 48. Number of participants with plasma HIV-1 RNA level <50 c/mL was obtained using Food and Drug Administration’s (FDA’s) snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switched their concomitant antiretroviral therapy (ART) prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however, the decision to switch is not documented as being before or at the first On-treatment visit after switching to optimized background regimen (OBR) (i.e. Day 28) where HIV-1 RNA is assessed.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48|ITT-E Population. The Snapshot dataset was used for analysis.|||Participants|||Count of Participants
1369907|NCT01568892|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. The Observed Case dataset, in which only the data that are available at the particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Log10 c/mL||Standard Deviation|Mean
1369908|NCT01568892|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. NA indicates data was not available.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Log10 c/mL||Standard Deviation|Mean
1369909|NCT01568892|Primary|Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.|Baseline and Day 8|ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.|||Log 10 copies per milliliter (c/mL)||Standard Error|Least Squares Mean
1369910|NCT01568866|Secondary|Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)|Pulmonary artery pressure was measured using transthoracic echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available PASP data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."|||mmHg||Standard Deviation|Mean
1369911|NCT01568866|Secondary|Change From Baseline in Right Ventricular Fractional Area Change (FAC)|Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."|||percent fractional area change||Standard Deviation|Mean
1369926|NCT01568424|Primary|Survival|"In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer).~In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant."|30 days post device removal||||percentage of survival at 30 days|||Number
1369912|NCT01568866|Secondary|Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)|"A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.~For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%."|Baseline and 24 weeks|Cardiopulmonary Safety Evaluable subgroup (all randomized participants who enrolled in the cardiopulmonary substudy with evaluable baseline echocardiogram scans per the central laboratory) and with both baseline and at least one post-baseline LVEF measurement within 24 weeks.|||percentage of participants|||Number
1369913|NCT01568866|Secondary|Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy|"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Safety population (all participants who received at least 1 dose of study treatment)|||percentage of participants||95% Confidence Interval|Number
1369914|NCT01568866|Secondary|Duration of Response|Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.|From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.|Intent-to-treat population with an overall response|||months||95% Confidence Interval|Median
1369915|NCT01568866|Secondary|Overall Response|"Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
1369916|NCT01568866|Secondary|Overall Survival|"Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient’s date of last contact (last known to be alive).~Median overall survival was estimated using the Kaplan-Meier method."|From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
1369917|NCT01568866|Primary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).~Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored."|From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively|Intent-to-treat population|||months||95% Confidence Interval|Median
1369918|NCT01568827|Primary|Serum IL-6|Area Under the time-concentration Curve (AUC) of IL-6|acute (0-12 hours) after inflammation-causing challenge meal||||(pg*hr)/mL||95% Confidence Interval|Mean
1369919|NCT01568593|Primary|Global Ocular Staining (With Oxford Scale - Ranges :0-15)|Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)|Baseline and 35 days|Per Protocol Population|||scores on a scale||Standard Deviation|Mean
1369920|NCT01568424|Secondary|Total Bilirubin|Total bilirubin is a measure of hepatic function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support|||mg/dl||Full Range|Median
1369921|NCT01568424|Secondary|Creatinine|Creatinine is a measure of renal function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support|||mg/dl||Full Range|Median
1369922|NCT01568424|Secondary|Blood Urea Nitrogen (BUN)|BUN is a measure of renal function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support|||mg/dl||Full Range|Median
1369923|NCT01568424|Secondary|Cardiac Index (CI)|Cardiac output (L/min) divided by the body surface area (m2)|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.|Patients with continuous RVAD support|||L/min/m2||Full Range|Median
1375076|NCT01509040|Secondary|Total Volume Intravenous Fluid Infused|This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.|48 hours||||mL||Inter-Quartile Range|Mean
1369927|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 5 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.|||hours||Standard Deviation|Mean
1369928|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 1 to Week 4|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.|||hours||Standard Deviation|Mean
1369929|NCT01568112|Secondary|Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Day 1 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.|||hours||Standard Deviation|Mean
1369930|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 5 to Week 8|Participants with a flushing event.|||minutes||Standard Deviation|Mean
1369931|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 1 to Week 4|Participants with a flushing event.|||minutes||Standard Deviation|Mean
1369932|NCT01568112|Secondary|Duration of Flushing Events During the Overall Treatment Period, Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Day 1 to Week 8|Participants with a flushing event.|||minutes||Standard Deviation|Mean
1369933|NCT01568112|Secondary|Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results|Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not abnormal and who had at least 1 post-baseline value.|||participants|||Number
1369934|NCT01568112|Secondary|Number of Participants With Abnormalities in Vital Signs|↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants who had a baseline value and had at least 1 post-baseline value.|||participants|||Number
1369935|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis|Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high or positive) and who had at least 1 post-baseline value.|||participants|||Number
1369936|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry|Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
1369937|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Hematology|Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
1369972|NCT01568008|Secondary|Physician Assessment of Treatment Tolerability Using a 4-Point Scale|The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
1373646|NCT01525407|Secondary|Chronic Extensive GVHD|Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.|2 years post transplant||||probability||95% Confidence Interval|Number
1369938|NCT01568112|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.|Day 1 up to end of Safety Follow-up (9 weeks)|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo).|||participants|||Number
1369939|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369940|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369941|NCT01568112|Primary|Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369942|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
1369943|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
1369944|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369945|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369946|NCT01568112|Primary|Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1373647|NCT01525407|Primary|Grade 3-4 Acute GVHD|Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.|First 100 days after transplant||||probability||95% Confidence Interval|Number
1369947|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369948|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369949|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369950|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
1369951|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
1369952|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369953|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1369954|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
1373648|NCT01525329|Secondary|Actinic Keratosis (AK) Clearance|Rate of AK clearance (Analyzed by linear mixed-effect model)|AK counts, over a 12-month period||||CR (% reduction)||95% Confidence Interval|Mean
1369955|NCT01568073|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3~Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4~The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.~The NMSS total score is calculated by adding all domain scores (0–360), and lower scores mean less disability."|14 to 15 weeks||||units on a scale||Standard Deviation|Mean
1369956|NCT01568073|Secondary|Parkinson's Disease Sleep Scale (PDSS)|"The Parkinson’s disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.~Subscale has 0-10 ratings, where 0 = severe and 10 = normal~The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14 to 15 weeks||||units on a scale||Standard Deviation|Mean
1369957|NCT01568073|Secondary|Total UPDRS SCORE (I, II (ON), and III)|"Total UPDRS (Part I, II (ON) and III)~UPDRS I evaluation of mentation, behavior, and mood~UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food~UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.~Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe~The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14 to 15 weeks||||units on a scale||Standard Deviation|Mean
1369958|NCT01568073|Primary|Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo,|The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period, This results refers when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations|14 to 15 weeks||||minutes||Standard Error|Mean
1369959|NCT01568047|Primary|Tmax - Time to Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days||||ng/mL||Full Range|Median
1369960|NCT01568047|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days||||ng.h/mL||Standard Deviation|Mean
1369961|NCT01568047|Primary|Cmax - Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days||||ng/mL||Standard Deviation|Mean
1369962|NCT01568034|Primary|Tmax = Time to Cmax Day 3|tmax = time to Cmax (values are median)|Day 3||||hours||Full Range|Median
1369963|NCT01568034|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)|AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)|Day 3||||ng.h/mL||Standard Deviation|Mean
1369964|NCT01568034|Primary|Cmax - Maximum Plasma Concentration Day 3|Cmax - Maximum plasma concentration (ng/mL)|Day 3||||ng/ml||Standard Deviation|Mean
1369965|NCT01568021|Secondary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.|||microns||Standard Deviation|Mean
1369966|NCT01568021|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.|||letters||Standard Deviation|Mean
1369967|NCT01568021|Primary|Time to First Re-treatment|Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.|1 Year|All Participants with complete data.|||days||95% Confidence Interval|Median
1369968|NCT01568008|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.|Week 12|All patients with complete data available for IOP.|||mm Hg||Standard Deviation|Mean
1369969|NCT01568008|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All patients with complete data available for IOP.|||mm Hg||Standard Deviation|Mean
1369970|NCT01568008|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
1369971|NCT01568008|Secondary|Physician Reported Reasons for Treatment Discontinuation|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
1369980|NCT01567852|Primary|Recovery Time|Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.|1 hour|Please see description from outcome 1|||minutes||Standard Deviation|Mean
1369981|NCT01567852|Primary|Re-orientation Time|Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.|1 hour|Since this was a crossover study, all patients received both drugs, except for 2 patients who dropped out after receiving the first drug. For one of these patients the drug was ketamine, for the other the drug was methohexital. Number of total trials analyzed was 69, with 35 Ketamine trials and 34 Methohexital trials|||minutes||Standard Deviation|Mean
1369982|NCT01567839|Primary|Successful Pulpal Anesthesia.|Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.|60 minutes||||participants|||Number
1369983|NCT01567826|Secondary|Blood Chemistry - HsCRP|Correlation of yellow plaque index with changes in levels of blood HsCRP as compared from baseline to 6-8 weeks after intervention|at baseline and at 6-8 weeks after intervention||||mg/l||Inter-Quartile Range|Median
1369984|NCT01567826|Secondary|Major Adverse Cardiac Events (MACE)|MACE defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days and 1 year. Details reported in adverse events section.|at 6-8 weeks after intervention||||participants|||Number
1369985|NCT01567826|Secondary|Post PCI Cardiac Enzymes|Correlation of yellow plaque index with post procedure CK-MB, Troponin-I release.|at 6-8 weeks after intervention||||ng/mL||Standard Deviation|Mean
1369986|NCT01567826|Secondary|Diameter Stenosis|Percentage stenosis of vessel diameter in the analysis segment of nontarget lesions as measured by angiography that remained >70%, after successful PCI of the target lesion.|Baseline and 6-8 weeks post intervention||||percentage of lesions|||Number
1369987|NCT01567826|Secondary|Fractional Flow Reserve (FFR) Value|Change in FFR as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention. Fractional flow reserve (FFR), defined as the ratio of maximum flow in the presence of a stenosis to normal maximum flow, is a lesion-specific index of stenosis severity that can be calculated by simultaneous measurement of mean arterial, distal coronary, and central venous pressure.|at baseline and at 6-8 weeks after intervention||||ratio||Standard Deviation|Mean
1369988|NCT01567826|Secondary|Intravascular Ultrasound (IVUS) Parameters|"Change in atheroma volume and lumen CSA on IVUS as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention.~Data not analyzed. Data not available."|at baseline and at 6-8 weeks after intervention||||mm^2||Standard Deviation|Mean
1369989|NCT01567826|Primary|Change in LCBI, Lesion|Change in LCBI at 6-8 weeks after intervention as compared to baseline|at baseline and at 6-8 weeks post intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||95% Confidence Interval|Median
1369990|NCT01567826|Primary|Change in LCBI4mm Max|Change in LCBI4mm max at 6-8 weeks after intervention as compared to baseline. LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||95% Confidence Interval|Median
1369991|NCT01567826|Primary|LCBI4mm Max|LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||Inter-Quartile Range|Median
1369992|NCT01567826|Primary|Lipiscan - Lipid Core Burden Index (LCBI)|The regression of yellow plaque content from the atherosclerotic lipid pool after statin therapy by utilizing NIR spectroscopy as compared from baseline to 6-8 weeks after intervention. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Analyses were performed offline using the Matlab-based software, as previously published. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||Inter-Quartile Range|Median
1369993|NCT01567527|Secondary|Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.|"Analysis of time from randomization to recurrence defined by hospitalization for a mood episode (Double-blind, Placebo-controlled Phase efficacy sample).~Time to recurrence is presented in the following table."|Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).|All randomized subjects who received at least one injection of IMP and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified ITT population.|||Days||95% Confidence Interval|Median
1369994|NCT01567527|Secondary|Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.|CGI-BP-S assessed the subject’s severity of Illness (mania) based on a 7-point scale ranging from 1 (normal/ not ill at all) to 7 (very severely ill).|Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).|All randomized subjects who received at least one injection of IMP and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified ITT population.|||Units on a scale||Standard Error|Least Squares Mean
1369995|NCT01567527|Secondary|Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode.|To assess the proportion of subjects who met criteria for recurrence of any mood episode (manic, mixed or depressive). Hierarchical procedure was used to preserve the overall Type I error at 0.05.|Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).|All randomized subjects who received at least one injection of IMP and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified ITT population.|||Participants|||Count of Participants
1369996|NCT01567527|Primary|Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.|"This endpoint was defined as meeting any of the following criteria:~Hospitalization for any mood episode OR~Any of the following:~YMRS total score ≥ 15 OR~MADRS total score ≥ 15 OR~CGI-BP-S score > 4 (overall score) OR~SAE of worsening disease (bipolar I disorder) OR~Discontinuation due to lack of efficacy or discontinuation due to an AE of worsening disease OR~Clinical worsening with the need for treatment of symptoms of an underlying mood disorder by addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, or increase greater than the allowed benzodiazepine doses, or~Active suicidality, which is defined as a score of 4 or more on the MADRS item 10 OR an answer of “yes” on question 4 or 5 on the C-SSRS.~The time to event is presented in the following table."|Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).|All randomized subjects who received at least one injection of investigational medicinal product (IMP) and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified intent-to-treat (ITT) population.|||Days||95% Confidence Interval|Median
1369997|NCT01567462|Secondary|Number of Participants With Disease Recurrence|The number of participants who had disease recurrence within the four month follow up period.|Post-Intervention (Up to 4 Months)|Participants who completed all study procedures per protocol.|||participants|||Number
1369998|NCT01567462|Secondary|Mean Catheterization Time|The average duration of the catheterization time was measured through study completion.|After Surgery Completion, Up to 336 Hours|Participants who required catheterization after the operative procedure.|||hours||Standard Deviation|Mean
1369999|NCT01567462|Secondary|Mean Operative Time|The average operative time was measured through study completion.|After Surgery Completion, Up to 174 Minutes|Participants who completed all study procedures per protocol.|||minutes||Standard Deviation|Mean
1370000|NCT01567462|Primary|Number of Procedural Complications|The number of procedural complications describes the total number of post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation events that occur within thirty days of the procedure.|Post-Intervention (Up to 30 Days)|Participants who completed all study procedures per protocol.|||complications|||Number
1370001|NCT01567371|Secondary|Difference in Stroke Volume Variability From Baseline to Post ANH.|The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day||||% variability||Standard Deviation|Mean
1370002|NCT01567371|Primary|Difference in Pulse Pressure Variability From Baseline to Post-ANH|The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day||||% variability||Standard Deviation|Mean
1370003|NCT01567163|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2.|||micrograms/milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1370004|NCT01567163|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2.|||micrograms*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1370005|NCT01567163|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment who had immunogenicity samples collected at the specified time points.|||participants|||Number
1370006|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 2.|||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1370007|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 1.|||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1370169|NCT01566331|Primary|Partecipant With Perineal Laceration|The following types of lacerations were recorded during delivery: cervical laceration; mild perineal lacerations (defined as 1-2 lacerations); severe perineal lacerations (defined as 3-4 lacerations)|after delivery|intervention in normal pregnancies at term during labor and delivery|||participants|||Number
1370008|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 2.|||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1370009|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 1.|||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1370010|NCT01567150|Secondary|Wound Healing|change in wound area mean was calculated for each subject Mean and sd were calculated for each group|12 weeks|average across 12 week time frame|||square cm||Standard Deviation|Mean
1370011|NCT01567150|Primary|Matrix Metalloproteinase Level in Wound Fluid|"Wound fluid will be collected and analyzed at baseline and approximately every 7 days.~Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups."|8 weeks|Overall mean across 8 week timeframe|||mcg/ml||Standard Deviation|Mean
1370012|NCT01567020|Secondary|Number of Participants With Decreased Amplitudes or Increased Latencies in Electrophysiological Tests of Central Auditory Function|"Tests to be administered:~Auditory Brainstem Response Long Latency Response"|six months|||||||
1370013|NCT01567020|Secondary|Functional Hearing Ability in Multitalker Environments||six months|||||||
1370014|NCT01567020|Secondary|Comprehensive Audiological Examination||six months|||||||
1370015|NCT01567020|Secondary|Number of Participants With Abnormal Ratings of Self-reported Ability to Process Auditory Information in Various Settings|"Questionnaires to be administered:~Hearing Health Inventory Speech, Spatial, and Qualities of Hearing"|six months|||||||
1370016|NCT01567020|Primary|Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing|"Tests to be administered:~Dichotic Digits Test: Percentage of digits reported correctly from 0 (worst performance) to 100 (best performance) Gaps in Noise Test: Approximate threshold in milliseconds from 2 (best) to 20 (worst) Staggered Spondaic Words Test: Total number of errors from 0 (best) to 40 (worst) Masking Level Differences Test: Difference in threshold between diotic and dichotic stimuli in decibels from 0 (worst) to 24 (best) Frequency Pattern Test: Percentage of sequences reported correctly from 0 (worst performance) to 100 (best performance) Adaptive Tests of Temporal Resolution: Not reported due to software error in stimulus presentation"|six months|Note that some of the participants finished all of the primary outcome measures but withdrew without finishing all of the secondary tests. They are thus listed as having withdrawn but are still included here for completeness.|||units on a scale||Standard Deviation|Mean
1370017|NCT01566981|Secondary|Change of the Following Parameter : HbA1C||baseline and six months|||||||
1370018|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and six months|||||||
1370019|NCT01566981|Secondary|Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.||baseline and one year||2013-11-30|11/2013||||
1370020|NCT01566981|Secondary|Quality of Patients' Life Via WONCA-COOP Questionnaire.||baseline and one year|||||||
1370021|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and one year|||||||
1370022|NCT01566981|Secondary|Patients' Functional Health Status Via WONCA-COOP Questionnaire.|WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 (‘no limitation at all’) to 5 (‘severely limited’); for ‘change in health’ score 1 means ‘much better’ and score 5‘much worse’. Sub-scales are averaged to compute a total score.|one year||||units on a scale||Standard Deviation|Mean
1370023|NCT01566981|Secondary|Body Mass Index at 1 Year||one year||||Kg/m2||Standard Deviation|Mean
1370024|NCT01566981|Primary|Change From Baseline in HbA1C at 1 Year.||1 year||||percentage of glycated haemoglobin||Standard Deviation|Mean
1370025|NCT01566838|Secondary|Resumed Physical Activity|Did the patient resume physical activity.|30 days|Resuming of physical activity|||participants|||Number
1370026|NCT01566838|Secondary|Return to Work|Returned to work in 30 days?|30 days|30 day return to work|||participants|||Number
1370027|NCT01566838|Secondary|30-day Incidence of Parasthesia|30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)|30 days|30-day incidence of paresthesia|||participants|||Number
1370028|NCT01566838|Secondary|Length of Stay|Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.|Participants will be followed for the duration of hospital stay, an expected average of 5 days|In-hospital length of stay (days)|||days||Inter-Quartile Range|Median
1370029|NCT01566838|Secondary|7-day Paresthesia|Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7|Postoperative day 1 through day 7|7-day paresthesia|||participants|||Number
1370030|NCT01566838|Primary|Number of Participants With and Without 30-Day Pain Medication Usage|The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.|Postoperative day 1 through postoperative day 30|30-day pain medication usage|||participants|||Number
1370031|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14|Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14|Day 1 through Day 14|MITT Population|||Liter||95% Confidence Interval|Least Squares Mean
1370032|NCT01566773|Secondary|Mean Number of Puffs of Rescue Medication (End of Treatment)|Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated|Day 14 (End of treatment)|MITT Population|||Puffs||95% Confidence Interval|Mean
1370777|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set|||ratio||95% Confidence Interval|Least Squares Mean
1370033|NCT01566773|Secondary|Change From Baseline in Mean Evening Post-dose Daily PEFR|Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)|Through the end of the 14-Day Treatment|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370034|NCT01566773|Secondary|Change From Baseline in Mean Evening Pre-dose Daily PEFR|Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)|Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370035|NCT01566773|Secondary|Change From Baseline in Mean Morning Post-dose Daily PEFR|Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]|Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370036|NCT01566773|Secondary|Change From Baseline in Mean Morning Pre-dose Daily PEFR|Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]|Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370037|NCT01566773|Secondary|Change From Baseline in 12-hour Post-dose Trough FEV1|12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline|Day 14 (Baseline, 11.5 and 12 hours post dose)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
1370038|NCT01566773|Secondary|Peak Change From Baseline in IC|Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)|Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
1370039|NCT01566773|Secondary|Change From Baseline for Mean Morning Pre-dose Trough IC|Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)|Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
1370040|NCT01566773|Secondary|Peak Change From Baseline in FEV1|Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)|Day 14|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
1370041|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1|Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)|Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
1370042|NCT01566773|Secondary|Mean Number of Puffs of Rescue Medication|Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated|Day 7|MITT Population|||Puffs||95% Confidence Interval|Mean
1370043|NCT01566773|Secondary|Change From Baseline in Mean Evening Post-dose PEFR|Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)|Day 7|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370044|NCT01566773|Secondary|Change From Baseline in Mean Evening Pre-dose PEFR|Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)|Day 7|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370045|NCT01566773|Secondary|Change From Baseline in Morning Post-dose Daily PEFR|Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])|Day 7 (30 minutes post-dose)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370046|NCT01566773|Secondary|Change From Baseline in Mean Morning Pre-dose Daily PEFR|Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])|Day 7 (60 minutes pre-dose, 30 minutes pre-dose)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
1370047|NCT01566773|Secondary|Peak Change From Baseline in IC|Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)|Day 7 (mean of 1 hr and 2 hr post-dose assessments)|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
1370048|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)|Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)|Day 7|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
1370049|NCT01566773|Secondary|Peak Change From Baseline in FEV1|Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)|Day 7|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
1370778|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1370050|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1|Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)|Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
1370051|NCT01566773|Secondary|Peak Change From Baseline in Inspiratory Capacity (IC)|Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline|Day 1 (1 hr and 2 hr post-dose )|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
1370052|NCT01566773|Secondary|Percentage of Subjects Achieving at Least 12% Improvement in FEV1|Percentage of subjects achieving at least 12% improvement in FEV1.|Day 1|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||Percentage of participants|||Number
1370053|NCT01566773|Secondary|Time to Onset of Action (>10% Improvement in FEV1) on Day 1|Time to Onset of Action (>10% Improvement in FEV1) on Day 1.|Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||% of participants|||Number
1370054|NCT01566773|Secondary|Peak Change From Baseline in FEV1|Highest value of FEV1 post dose on day 1|Day 1|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
1370055|NCT01566773|Primary|FEV1 AUC0-12|Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.|Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)|MITT (Modified Intent to Treat) Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||Liter||95% Confidence Interval|Least Squares Mean
1370056|NCT01566721|Secondary|Percentage of Participants by Item Response to SID Satisfaction Questionnaire|"The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from Strongly Disagree to Strongly Agree. Questionnaire items were as follows: I felt comfortable injecting the study drug by myself (Comfortable), The SID was convenient and easy to use (Easy to Use), I am confident giving myself an injection in the thigh with the SID (Confident), Taking all things into account I find self-administration using the SID satisfactory (Satisfactory), If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire."|Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)|Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.|||percentage of participants|||Number
1370057|NCT01566721|Secondary|Overall Survival (OS)||From Baseline to time of event (up to approximately 8 years)|||||||
1370058|NCT01566721|Secondary|Percentage of Participants Who Died by Data Cutoff of 10 March 2015|The percentage of participants who died from any cause was reported.|From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)|ITT Population|||percentage of participants|||Number
1370059|NCT01566721|Secondary|Disease-Free Survival (DFS)|DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.|From Baseline to time of event (up to approximately 8 years)|||||||
1370060|NCT01566721|Primary|Percentage of Participants Who Received Concomitant Non-Cancer Therapy|Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.|From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)|Safety Population|||percentage of participants|||Number
1370061|NCT01566721|Primary|Percentage of Participants Who Received Concomitant Cancer Therapy|Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.|From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)|Safety Population|||percentage of participants|||Number
1370062|NCT01566721|Primary|Percentage of Participants by Total Number of Herceptin Cycles Received|Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.|||percentage of participants|||Number
1370063|NCT01566721|Primary|Number of Herceptin Cycles Received|Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.|||cycles||Full Range|Median
1370064|NCT01566721|Primary|Percentage of Participants With Treatment Interruption Due to an AE|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population|||percentage of participants|||Number
1370065|NCT01566721|Primary|Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population|||percentage of participants||95% Confidence Interval|Number
1370066|NCT01566721|Primary|Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.|||percentage of participants|||Number
1370067|NCT01566630|Secondary|Mean Number of Days Before Delivery||From randomization until delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370068|NCT01566630|Primary|Pharmacokinetics of RLX030: Mean Residence Time (MRT)|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370069|NCT01566630|Primary|Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370070|NCT01566630|Primary|Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370071|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370072|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to Infinity (AUCinf)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370073|NCT01566630|Primary|Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile||Randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370074|NCT01566630|Primary|Number of Patients With Abnormalities in Birth Weight, Gestational Age, Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Score, Umbilical Cord Gases, and Days in Neonatal Intensive Care Unit (NICU)||up to 4 - 6 weeks post partum (maximum of 8 weeks )|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370075|NCT01566630|Primary|Number of Patients With Absence of Anti-serelaxin Antibodies||From Randomization until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370076|NCT01566630|Primary|Rate of Spontaneous Delivery and/or Mode of Delivery||From randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370077|NCT01566630|Primary|Improvement in Renal Function Assessed by Increase in Creatinine Clearance||From randomization until 4-6 weeks post partum (maximum 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370078|NCT01566630|Primary|Change in Fetal Heart Rate (Part 1)|Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370079|NCT01566630|Primary|Decrease in Utero-placental Blood Flow (Part 1)|Blood flow to the fetus was monitored using via a Doppler.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370080|NCT01566630|Primary|Change From Baseline on Maternal Proteinuria (Part 1)|Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370081|NCT01566630|Primary|Change From Baseline in Mean Maternal Arterial Pressure (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370082|NCT01566630|Primary|Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
1370083|NCT01566630|Primary|Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study|Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.|Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed.|||Participants|||Number
1370084|NCT01566604|Secondary|The Total Score of the St George's Respiratory Questionnaire (SGRQ)|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity and impacts. The lowest possible score is zero and the highest possible score is 100. Higher scores correspond to greater impairment in quality of life. The health-related quality of life was measured using SGRQ. It was completed by the participant at the investigators site.|Week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.|||Score||Standard Error|Least Squares Mean
1370085|NCT01566604|Secondary|Number of Moderate and Severe COPD Exacerbations|COPD exacerbations were recorded in the patient diary and other source documents. The rate of COPD exacerbations during the 26 week treatment period was analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.|||Number of exacerbations||Standard Deviation|Mean
1370086|NCT01566604|Secondary|Time to First Moderate or Severe COPD Exacerbation|A COPD exacerbation was defined as a worsening of the following two or more major symptoms for at least 2 consecutive days:1) dyspnea; 2) sputum volume; 3) sputum purulence; or defined as a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: 1) sore throat; 2) colds (nasal discharge and/or nasal congestion); 3) fever without other cause; 4) cough; 5) wheeze. COPD exacerbations were recorded in the patient diary and other source documents.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.|||Days||Full Range|Median
1370087|NCT01566604|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)|In an electronic diary, the participant responded to 6 questions twice daily to report on the degree of symptoms over the past 12 hours of the morning and evening. The questions covered the participant’s degree of overall symptoms, and degrees of individual symptoms of coughing, wheezing, amount of sputum, color of sputum and breathlessness. Each question scored from 0 to 3 where 0 represented no symptom present and 3 represented the worst degree of that symptom. A negative change in symptom score indicates improvement.|Baseline, 26 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given symptom category, analyzed participants had both baseline and week 26 values.|||score||Standard Error|Least Squares Mean
1370088|NCT01566604|Secondary|Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose|The standardized (with respect to time) AUC for FEV1 was calculated between 5 min and 4h post morning dose at day 1, week 12 and week 26. The AUC (5 min-4 h) for FEV1 at each visit was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.|||Liters||Standard Error|Least Squares Mean
1370089|NCT01566604|Secondary|Peak FEV1|Peak FEV1 was defined as the maximum FEV1 0-4 h post-dose. Peak Fev1 was measured at 45min and 15min pre-dose and up to 4h post dose at day 1, week 12 and week 26, using central spirometry according to ATS/ERS standardization. It was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.|||Liters||Standard Error|Least Squares Mean
1370090|NCT01566604|Secondary|FEV1 and Forced Vital Capacity (FVC)|FEV1 and FVC were measured using central spirometry according to ATS/ERS standardization. Both were analyzed using the same MIXED model as specified for the primary analysis.|Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, e.g. day 1, 5 min; day 1, 15 min, etc..|||Liters||Standard Error|Least Squares Mean
1370091|NCT01566604|Secondary|24h Trough FEV1|Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. This was measured using central spirometry according to ATS/ERS standardization. This was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, Week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1 or week 26.|||Liters||Standard Error|Least Squares Mean
1370092|NCT01566604|Secondary|Change From Baseline in Daily Rescue Medication Use (Number of Puffs)|The participant recorded the rescue medication taken in an electronic diary between visits and in the spirometry device during study visits. Daytime and nighttime rescue medication use (number of puffs) over 26 weeks was analyzed.|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study medication.|||Number of puffs||Standard Error|Least Squares Mean
1370093|NCT01566604|Secondary|Transition Dyspnea Index (TDI) Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during the treatment period using the TDI, which captures changes from baseline. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort, and each domain scored from -3 (major deterioration) to +3 (major improvement), giving an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Baseline, week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.|||score||Standard Error|Least Squares Mean
1370094|NCT01566604|Primary|Trough Forced Expiratory Volume in One Second (FEV1)|Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.|12 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, participants analyzed had both baseline and week 12 values.|||Liters||Standard Error|Least Squares Mean
1370095|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Testosterone Plasma Level|Peripherals levels of testosterone will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the first batch of data collection from Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Due to the lack of funds, no subsequent analysis has been done on the samples collected.|||ng/dl||Standard Deviation|Mean
1370096|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level|Peripheral levels of OT will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.|||pg/ml||Standard Error|Mean
1370097|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level|Peripheral levels of AVP will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.|||pg/ml||Standard Error|Mean
1370098|NCT01566539|Secondary|Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.|Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)|Data was collected per protocol in the OT and placebo empathy task groups.|||percent signal change||Standard Deviation|Mean
1370099|NCT01566539|Secondary|Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.|Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)|Data was collected per protocol in the OT and placebo empathy task groups.|||percent signal change||Standard Deviation|Mean
1370100|NCT01566539|Secondary|Faces Task Groups: Mean Attractiveness Rating of Faces in Women|Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
1370101|NCT01566539|Secondary|Faces Task Groups: Mean Attractiveness Rating of Faces in Men|Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
1370102|NCT01566539|Secondary|Faces Task Group: Mean Approachability Rating of Faces in Women|Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
1370103|NCT01566539|Secondary|Faces Task Groups: Mean Approachability Rating of Faces in Men|Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
1370779|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1370104|NCT01566539|Secondary|Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||percent signal change||Standard Deviation|Mean
1370105|NCT01566539|Secondary|Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||percent signal change||Standard Deviation|Mean
1370106|NCT01566539|Secondary|Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis.|||number of choices||Standard Deviation|Mean
1370107|NCT01566539|Secondary|Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis. The difference between OT and PL visits is reported here (OT-PL).|||number of choices||Standard Deviation|Mean
1370108|NCT01566539|Secondary|Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||number of choices||Standard Error|Mean
1370109|NCT01566539|Secondary|Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||number of choices||Standard Error|Mean
1370110|NCT01566539|Primary|Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women|The effect of the drug will be assessed by determining changes in brain activation between the visit where the participant received drug and the visit where the participant received PL in the right caudate during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the within subject group per protocol. Subjects with excessive motion during scanning were excluded from the analysis.|||percent signal change||Standard Deviation|Mean
1370111|NCT01566539|Primary|Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
1370112|NCT01566539|Primary|Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
1370113|NCT01566539|Primary|Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
1370114|NCT01566539|Primary|Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
1370115|NCT01566526|Secondary|Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 3 lines in BCVA.|||Days||Full Range|Median
1370116|NCT01566526|Secondary|Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 2 lines in BCVA.|||Days||Full Range|Median
1370117|NCT01566526|Secondary|Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.|||Micrometers (µm)||Standard Deviation|Mean
1370118|NCT01566526|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.|||Percent of Participants|||Number
1370119|NCT01566526|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.|||Percent of Participants|||Number
1370120|NCT01566526|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.|||Letters||Standard Deviation|Mean
1370121|NCT01566526|Primary|Time to OZURDEX® Re-Injection in the Study Eye|The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.|Up to 12 Months|All enrolled patients.|||Days||Standard Deviation|Mean
1370122|NCT01566500|Secondary|Score of Psychosocial Predictors of Adherence|The Fisher IMB (Information-Seeking, Motivation and Behavior) adherence questionnaire will measure what psychosocial factors that act as predictive of medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a twelve month recall period.|Enrollment|||||||
1370123|NCT01566500|Secondary|Score on Barriers to Medication Adherence|The Chesney Adherence Questionnaire will be used to measure side effects, drug use and other barriers to medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a four-week recall period.|Enrollment|||||||
1370124|NCT01566500|Primary|Raw Count of Number of Days of Medication Nonadherence|"The primary outcome of this study is medication adherence as measured by self report with a 4 day recall adherence questionnaire (Chesney, Ickovics, Chambers, et al., 2000).~The total number of Nonadherence days were counted, then divided by the total number of days for all participants."|Enrollment|Adults with self-reported epilepsy.|||% of nonadherence days|||Number
1370125|NCT01566461|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Days||Standard Deviation|Mean
1370126|NCT01566461|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (n=331)|||Percentage of participants|||Number
1370127|NCT01566461|Secondary|Procedural Success|Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.|Day 1|Intention-to-Treat (n=331)|||Percentage of participants|||Number
1370128|NCT01566461|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).|||Percentage of devices|Devices||Number
1370129|NCT01566461|Secondary|Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.~Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
1370130|NCT01566461|Secondary|Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)|Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.|From baseline to 12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe. Data not collected in IN.PACT SFA I phase.|||Meters||Standard Deviation|Mean
1370131|NCT01566461|Secondary|Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.~EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
1370132|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370133|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370134|NCT01566461|Secondary|Secondary Sustained Clinical Improvement|Freedom from target amputation and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of particpants|||Number
1370135|NCT01566461|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370136|NCT01566461|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370137|NCT01566461|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370138|NCT01566461|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.|||Days||Standard Deviation|Mean
1370139|NCT01566461|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370140|NCT01566461|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370141|NCT01566461|Secondary|All-cause Death||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370142|NCT01566461|Secondary|Major Adverse Event (MAE) Composite|Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370143|NCT01566461|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of particpants|||Number
1370144|NCT01566461|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1370145|NCT01566435|Secondary|Progression-free Survival (PFS)|-Progression: at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2 years||||percentage of participants|||Number
1370146|NCT01566435|Secondary|Disease-free Survival (DFS) Rate||2 years||||percentage of participants|||Number
1370147|NCT01566435|Secondary|Changes in Ki-67 Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||2023-10-31|10/2023||||
1370148|NCT01566435|Secondary|Complete Response (CR) or Partial Response (PR) at Regional (Neck) Nodes as Measured by Clinical Exam||6 weeks (2 cycles of therapy)|2 participants were not evaluable for this outcome measure.|||participants|||Number
1370149|NCT01566435|Secondary|Quality of Life (QOL)|"Assessed using questionnaires administered at 6 time points starting at baseline.~4 page questionnaire will assess physical, social, emotional, and functional well-being through questions designed specifically for patients with head and neck cancer.~An additional 4 question QOL survey will assess symptoms of peripheral neuropathy."|Through one year after completion of treatment||2023-10-31|10/2023||||
1370170|NCT01566162|Secondary|Intent to Attend Assessment|The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: “How likely is it that you will complete the study?”|12 weeks|Only 1825 subjects answered the questionnaire.|||units on a scale||Standard Deviation|Mean
1370150|NCT01566435|Secondary|Changes in Secreted Protein Acidic and Rich in Cysteine (SPARC) Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|SPARC and Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||2023-10-31|10/2023||||
1370151|NCT01566435|Secondary|Adverse Events as Measured by Number of Participants That Experienced Each Common Adverse Event During ACF Induction Therapy|Assessed by NCI-CTCAE version 3|From start of treatment through 30 days after end of treatment||||participants|||Number
1370152|NCT01566435|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who are alive at 2 years.|2 years||||percentage of participants|||Number
1370153|NCT01566435|Secondary|Metabolic Tumor Responses as Measured by FDG-PET/CT|"Complete metabolic response (CMR): Complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions~Partial metabolic response (PMR): 20% or greater decrease in max SUV from baseline, no metabolic progression of non-target lesions and no new lesions and/or decrease in total number of non-target lesions, no new lesions~Stable metabolic disease (SMD) - does not qualify for CMR, PMR, or PMD~Progressive metabolic disease (PMD): development of one or more metabolically active lesions or 20% or greater increased in max SUV from baseline, new metabolically active lesions"|6 weeks (2 cycles of therapy)|29 participants out of 30 participants were evaluable for this outcome measure.|||participants|||Number
1370154|NCT01566435|Secondary|Number of Participants Per Anatomic Tumor Response by CT Scan|"Response assessed using RECIST criteria version 1.0~Complete response: disappearance of all target lesions~Partial response: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter~Non-complete response/non-progression: persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal.~Progression: at least a 20% increase in the sum of the LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 weeks (2 cycles of therapy)||||participants|||Number
1370155|NCT01566435|Secondary|Percentage of Participants With Partial Response (PR) at Primary Tumor Site|"Response will be assessed by laryngoscopy.~PR: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter"|6 weeks (2 cycles of therapy)||||percentage of participants|||Number
1370156|NCT01566435|Primary|Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site|"Response will be assessed by laryngoscopy.~CR: disappearance of all lesions"|6 weeks (2 cycles of therapy)||||percentage of participants|||Number
1370157|NCT01566409|Secondary|Usage of Laxative||½ year|||||||
1370158|NCT01566409|Primary|Treatment Recovery|Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.|½ year||||participants|||Number
1370159|NCT01566370|Secondary|Change in Number of Drinks Per Week by Time|Comparison between medication and placebo groups on the change in number of drinks per week via interaction with time (from baseline to endpoint) using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370160|NCT01566370|Secondary|Change in Number of Heavy Drinking Days Per Week by Time|A comparison between medication and placebo on the measure of number heavy drinking days per week over the course of the study (baseline to endpoint) via interaction with time using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370161|NCT01566370|Secondary|Percentage of Total Drinking Days|The percentage of total drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|4 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370162|NCT01566370|Secondary|Change in Beck Depression Inventory (BDI) Scores|Comparison between groups on change in BDI scores over the 14 weeks of the study, measured weekly, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370163|NCT01566370|Secondary|Change in Gamma Glutamyl Transferase (GGT)|Difference between groups on change in levels of GGT over time, measured at baseline, week 5, week 9, week 13, and endpoint, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370164|NCT01566370|Secondary|Change in Alcohol Urge Questionnaire Score|This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures|from baseline to endpoint, 14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370165|NCT01566370|Secondary|Percentage of Abstinent Days|The difference in total percentage of abstinent compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|over four weeks, from week 11 through 14|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370166|NCT01566370|Primary|Change in Clinician Assisted Rating Scale for Mania (CARS-M) Scores|Comparison between groups on change in scores on the CARS-M over 14 weeks from baseline to endpoint, measured weekly and analyzed with repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370167|NCT01566370|Primary|Change on Hamilton Depression Rating Scale|Change from baseline to endpoint in Hamilton scores compared between medication and placebo, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1370168|NCT01566370|Primary|Percentage of Total Heavy Drinking Days|The percentage of total heavy drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), totaled between the time-points of weeks 11 and 14 (4 weeks time frame).|from week 11 through 14 (over 4 weeks)|None of the subjects completed the study or made it to the 12 week endpoint.||||||
1385253|NCT01405027|Secondary|Drug Exposure|Total number of patients receiving treatment over specified time intervals.|End of treatment up to treatment week 48||||participants|||Number
1370172|NCT01566162|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.|12 weeks||||percentage of monthly doses taken||Standard Deviation|Mean
1370173|NCT01566162|Secondary|Modified Specific Levels of Functioning (SLOF) Total Score.|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.|12 weeks|Only 174 subjects had SLOF assessments at week 12 LOCF.|||units on a scale||Standard Deviation|Mean
1370174|NCT01566162|Secondary|Short Form-12 Health Survey (SF-12)|The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline SF-12.v2 assessments.|||units on a scale||Standard Deviation|Mean
1370175|NCT01566162|Secondary|Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline MADRS assessments.|||units on a scale||Standard Deviation|Mean
1370176|NCT01566162|Primary|Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint||||units on a scale||Standard Deviation|Mean
1370177|NCT01566162|Primary|Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint||||units on a scale||Standard Deviation|Mean
1370178|NCT01566162|Primary|Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)|Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)|12 weeks||||participants|||Number
1370179|NCT01566149|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.|Baseline and Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication and had at least one efficacy measurement post-dose.|||liters||Standard Deviation|Mean
1370180|NCT01566149|Primary|Number of Participants Who Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
1370181|NCT01566149|Primary|Number of Participants With At Least One Serious AE|"A serious AE was defined as any untoward medical occurrence or effect that at~any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer."|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
1370182|NCT01566149|Primary|Number of Participants With At Least One Drug-Related AE|A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
1370183|NCT01566149|Primary|Number of Participants With At Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 14|The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
1370184|NCT01566084|Secondary|BH4 Bioavailability|Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability.|Immediately following acute administration of BH4 on Weeks 5 and 10|BH4 could not be administered to 3 participants due to canceled visits.|||percentage dilation||Standard Deviation|Mean
1370678|NCT01562275|Secondary|Maximum Plasma Concentration (Cmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1370185|NCT01566084|Secondary|Vascular Oxidative Stress|Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative.|Immediately following acute infusion of ascorbic acid on Weeks 5 and 10|Ascorbic acid is missing in one participant due to a failed i.v.|||percentage dilation||Standard Deviation|Mean
1370186|NCT01566084|Primary|Improved Flow Mediated Dilation|FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks.|Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)|All subjects are analyzed under each condition because of the cross-over design.|||percentage dilation||Standard Deviation|Mean
1370187|NCT01565993|Secondary|Difficult to Place the Clip|The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.|During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)|||||||
1370188|NCT01565993|Primary|The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)|"In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called complications, despite their severity and clinical significance"|Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding|Based on an anticipated decrease of at least 12% in the rate of adverse bleeding events between the group A and the group B, there was an alpha error of 0.05 and a statistical power of 80% with a patient inclusion rate of 1:1. The number of polyps required is 146 per group. Using the Fleiss correction, the final number is 164 per group.|||polyps|Participants||Number
1370189|NCT01565980|Other Pre-specified|Baseline Values for All Measures.|Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.|Baseline.||||units on a scale||Standard Deviation|Mean
1370190|NCT01565980|Other Pre-specified|Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)|The PSSQ_I has 13 self rated questions. The first 5 items, used to determine sleep quality (presence; frequency of insomnia problems) are rated [0 = never to 5 = always, 5-7 days per week; (range 0-25)] and items 6 to 13 are aimed at identifying the degree of interference experienced from sleep impairment (rated 0=not at all to 4=extremely on Likert scale; range 0 - 32).|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
1370191|NCT01565980|Other Pre-specified|Worry (Cancer-related and General)|"Both cancer-related and general worry were measured with 3 item scales. Cancer-related worry had three statements asking about level of worry related to diagnosis, treatment, and worry interference using a 1 = not at all to 5 = most or all the time scale, range 3-15. Items are summed. General worry used an abbreviated brief Penn State Worry questionnaire with 3 statements that measure how typical that statements are in describing the person. Uses a 3 item scale with 1 = not at all typical to 5 = very typical. the range is 3-15. Items are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
1370192|NCT01565980|Other Pre-specified|Cancer Dyspnea Scale|"The cancer dyspnea scale (CDS) has 12 Likert scale items ( 1 = Not at all, 5 = Very much) that ask questions about breathlessness or difficulty in breathing during the past few days. The CDS has an overall score (range 0-42) and 3 subscales that measure the amount of effort with breathing, anxiety associated with breathing, and discomfort associated with breathing.~The 3 subscales are calculated by: 1) effort (items 4+6+8+10+12) – 5 [range 0 (no dyspnea effort)-20 (worst dyspnea effort)]; 2) anxiety (items 5+7+9+11) – 4 [range 0 (no dyspnea anxiety) - 16 (worst dyspnea anxiety)]; 3) discomfort [15 – (items 1+2+3) {range 0 (no dyspnea discomfort) - 12 (worst dyspnea discomfort)}]. The total dyspnea score is derived by adding the total subscale scores. The subscale score subtractions are to make adjustments for 0 as a state of absence of dyspnea (thus total dyspnea summary scores range from 0 to 42)."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
1370193|NCT01565980|Other Pre-specified|Center for Epidemiologic Studies Depression (CES-D)|The score is the sum of the 20 questions. Each item has a range of 1 - 4 for frequency of a behavior or mental state in the past week ; 1 - Rarely or none of the time (less than 1 day); 2 = Some or a little of the time (1-2 days); 3 = Occasionally or a moderate amount of time (3-4 days); 4 = Most or all of the time (5-7 days). Possible range is 0-60. There are 4 reverse-scored items (questions 4, 8, 12, and 16). A score of 16 points or more is considered depressed.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
1370194|NCT01565980|Primary|SF-36|Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range). With normed scoring, general population has mean=50, SD=10. For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and standards error provided for T2 & 3, folllowed by summary of linear mixed effects models for the outcomes for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
1370207|NCT01565941|Secondary|Incidence of Ventilator-Associated Pneumonia|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: respiratory tract infections including ventilator-associated pneumonias that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.|Up to 48 hours after ICU discharge||||Infections/1000 ventilator days|||Number
1370208|NCT01565941|Secondary|Incidence of Catheter-Associated Urinary Tract Infection|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: urinary tract infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.|Up to 48 hours after ICU discharge||||Infections/1000 bladder catheter days|||Number
1370694|NCT01562132|Primary|Survival at 12 Weeks||12 weeks||||participants|||Number
1385299|NCT01404078|Primary|Tolerability of a Double Dose of Half Strength Polycap||8 weeks|||||||
1370195|NCT01565980|Primary|M.D. Anderson Symptom Inventory (MDASI)|"Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom “at its worst” using 0–10 numerical rating scales with 0 = “not present” and 10 = “as bad as you can imagine.” The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = did not interfere; 10 = interfered completely). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and their standard errors are reported for times 2 and 3. The summary of linear mixed effects for group comparisons are then presented.|||units on a scale||Standard Error|Least Squares Mean
1370196|NCT01565941|Secondary|Insulin Algorithm Performance: Time-Weighted Glucose Average|Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.|Until study discharge, up to 28 days following randomization||||mg/dL||Inter-Quartile Range|Median
1370197|NCT01565941|Secondary|Insulin Algorithm Performance: Time in the Target Range|Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will maximize time spent in the glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.|Until study discharge, up to 28 days following randomization||||Percentage of time||Inter-Quartile Range|Median
1370198|NCT01565941|Secondary|Insulin Algorithm Performance: Time to the Target Range|Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will minimize time to glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.|Until study discharge, up to 28 days following randomization||||Hours||Inter-Quartile Range|Median
1370199|NCT01565941|Secondary|Nursing Workload|The cognitive burden placed upon bedside nurses when managing a patient on TGC will be described. Bedside nurses will be randomly selected to complete an anonymous survey describing their perceptions of workload burden associated with managing a patient on TGC. Nurses' perceptions of their capacity to complete both TGC‐related and non TGC-related nursing activities over several intervals of the study period will be described via qualitative and summary statistics.|Multiple intervals during the study period|||||||
1370200|NCT01565941|Secondary|Developmental Neurobehavioral Outcomes|Reliable, reproducible measures of adaptive functioning, behavior and quality of life will be used to determine outcomes at baseline (CBCL, PedsQL) and at one year after ICU discharge (Vineland-II, CBCL, PedsQL). The goal of baseline data collection is to assess pre-ICU health and quality of life.|Baseline and 1 year after ICU course|||||||
1370201|NCT01565941|Secondary|Participants With Hypokalemia (<2.5 mmol/L)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
1370202|NCT01565941|Secondary|Participants With Any Hypoglycemia (<60 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
1370203|NCT01565941|Secondary|Participants With Any Hypoglycemia (<60 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
1370204|NCT01565941|Secondary|Participants With Severe Hypoglycemia (<40 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
1370205|NCT01565941|Secondary|Participants With Severe Hypoglycemia (<40 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
1370206|NCT01565941|Secondary|Incidence of Wound Infection Incidence of Wound Infection|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This non-device-related infection will be counted per 1,000 ICU days.|Up to 48 hours after ICU discharge||||Infections/1000 ICU days|||Number
1370780|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1370209|NCT01565941|Secondary|Incidence of Catheter-Associated Bloodstream Infection|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: Central Venous Line (CVL)-associated bloodstream infections (BSI) that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.|Up to 48 hours after ICU discharge||||Infections/1000 CVC days|||Number
1370210|NCT01565941|Secondary|Participants With Device-Related or Non-Device Related Nosocomial Infection|We will use Centers for Disease Control's (CDC) most recently published definitions for the following nosocomial infections attributable to the ICU stay: total bloodstream infections including Central Venous Line (CVL)-associated bloodstream infections (BSI), respiratory tract infections including ventilator-associated pneumonias, urinary tract infections, and wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit.|Up to 48 hours after ICU discharge||||Participants|||Count of Participants
1370211|NCT01565941|Secondary|Ventilator-Free Days|Ventilator-free days during the 28 days following randomization encompasses both reduction in the duration of ventilation and improvement in mortality. The end of the subject's duration of ventilation is defined as the date/time of extubation for subjects who are intubated, or the date/time of the discontinuation of mechanical ventilation for subjects with tracheostomy.|28 days following randomization||||Days||Inter-Quartile Range|Median
1370212|NCT01565941|Secondary|Accumulation of Multiple Organ Dysfunction Syndrome (MODS)|Accumulation of MODS during the 28 days following randomization will be measured. MODS is defined as the concurrent dysfunction of two or more organ systems (e.g., acute lung injury and renal failure). The clinical relevance of MODS as a surrogate outcome measure is well recognized in the intensive care community, and there is a clear relationship between the number of dysfunctional organ systems and the risk of death in critically ill children.|28 days after randomization|||||||
1370213|NCT01565941|Secondary|28-day Hospital Mortality|We will collect data on 28-day hospital mortality.|28 days after randomization||||Participants|||Count of Participants
1370214|NCT01565941|Secondary|90-day Hospital Mortality|In order to enable direct comparisons between data gathered in HALF-PINT and the prior adult NICE-SUGAR trial, we will collect data on 90-day hospital mortality.|90 days after randomization||||Participants|||Count of Participants
1370215|NCT01565941|Primary|ICU-Free Days|28-day hospital mortality-adjusted ICU length of stay.|Study day 28||||Days||Inter-Quartile Range|Median
1370216|NCT01565902|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312|Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, α-fetoprotein [in hepatically impaired subjects only], pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, suicidality assessment (C-SSRS), (serious) adverse event monitoring.|Day -1 to 22|The safety analysis set consists of all subjects that received study drug and with no protocol deviations with relevant impact on safety.|||Participants|||Number
1370217|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment|||(ng/mL)||Standard Deviation|Mean
1370218|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment|||h*ng/mL||Standard Deviation|Mean
1370219|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment|||h*ng/mL||Standard Deviation|Mean
1370220|NCT01565889|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug(s)|||percentage of participants|||Number
1370221|NCT01565889|Other Pre-specified|Part B: On-treatment HIV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Safety Analysis Set: participants enrolled in Part B and received at least one dose of study drug(s).|||copies/mL||Standard Deviation|Mean
1370222|NCT01565889|Other Pre-specified|Part B: On-treatment HCV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1370781|NCT01560234|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event|Screening up to Day 13|Safety Analysis Set|||participants|||Number
1370223|NCT01565889|Secondary|Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set|||percentage of participants|||Number
1370224|NCT01565889|Secondary|Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|"SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set|||percentage of participants|||Number
1370225|NCT01565889|Primary|Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Week 12|Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s)|||percentage of participants|||Number
1370226|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7|"Cmax: maximum observed concentration of drug in plasma.~Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|Participants in the PK Analysis Set with available data were included.|||ng/mL||Standard Deviation|Mean
1370227|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7|"AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).~Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|"Pharmacokinetics (PK) Analysis Set: participants with evaluable PK profiles who enrolled into Part A of the study and received study drug.~Participants in the PK Analysis Set with available data were included."|||h*ng/mL||Standard Deviation|Mean
1370228|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.|||cells/µL||Standard Deviation|Mean
1370229|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.|||cells/µL||Standard Deviation|Mean
1370230|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1370231|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1370232|NCT01565850|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1370233|NCT01565850|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participant who were randomized;enrolled and received at least one dose of study drug|||percentage of participants|||Number
1370234|NCT01565707|Secondary|Change From Baseline in Post Void Residual (PVR) Volume|Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|The study analysis population for this endpoint consisted of the SAF.|||mL||Standard Deviation|Least Squares Mean
1370235|NCT01565707|Secondary|Number of Participants With Adverse Events (AEs)|A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.|From the first dose of study drug until 7 days after last dose of study medication (13 weeks).|The study analysis for this endpoint consisted of the Safety Analysis Set (SAF), the SAF consisted of all patients who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug.|||participants|||Number
1370236|NCT01565707|Secondary|Apparent Volume of Distribution (Vz/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||L||Standard Deviation|Mean
1370237|NCT01565707|Secondary|Apparent Total Body Clearance (CL/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||L/h||Standard Deviation|Mean
1370238|NCT01565707|Secondary|Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||hours||Standard Deviation|Mean
1370239|NCT01565707|Secondary|Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||ng*h/mL||Standard Deviation|Mean
1370707|NCT01561755|Secondary|Impression of Change Score - Participant|The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening|at 2 months||||units on a scale||Full Range|Mean
1370240|NCT01565707|Secondary|Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||ng/mL||Standard Deviation|Mean
1370241|NCT01565707|Secondary|Time to Attain Maximum Concentration (Tmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||hours||Standard Deviation|Mean
1370242|NCT01565707|Secondary|Maximum Concentration (Cmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS. The PKAS consisted of the subset of the Safety Analysis Set (SAF) for which plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of last dose prior to sampling was known.|||ng/mL||Standard Deviation|Mean
1370243|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents|Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS including participants for whom data were available (adolescents only). Missing values at EoT were imputed using the last observation carried forward (LOCF) method.|||urgency episodes||Standard Error|Least Squares Mean
1370244|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||nighttime micturitions||Standard Error|Least Squares Mean
1370245|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||daytime micturitions||Standard Error|Least Squares Mean
1370246|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||micturitions||Standard Error|Least Squares Mean
1370247|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days|The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||Dry Nights||Standard Error|Least Squares Mean
1370248|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days|The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||Dry Days||Standard Error|Least Squares Mean
1370249|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||nighttime incontinence episodes||Standard Error|Least Squares Mean
1370250|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and Week 12|Full analysis set including patients for whom data were available. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.|||daytime incontinence episodes||Standard Error|Least Squares Mean
1373757|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.|At arrival to the postanesthesia care department, 2 hours and 1 day after surgery|||||||
1370251|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||incontinence episodes||Standard Error|Least Squares Mean
1370252|NCT01565707|Secondary|Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition|The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||mL||Standard Error|Least Squares Mean
1370253|NCT01565707|Primary|Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition|The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|Full Analysis Set (FAS) consists of all randomized patients that took at least one dose of double-blind study medication after randomization and provided both valid baseline and post-baseline values for the primary efficacy endpoint. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.|||mL||Standard Error|Least Squares Mean
1370254|NCT01565642|Secondary|Hospitalizations|Number and timing of transfer to hospital from nursing home care, measured as hospital transfers per 90 person-days of follow-up, with follow-up censored at death.|9 months||||Hospital transfers per 90 person-days|||Number
1370255|NCT01565642|Secondary|Hospice Referral|Number of participants with a referral to hospice services|9 months||||Participants|||Count of Participants
1370256|NCT01565642|Secondary|Frequency of Communication|Number of participants who report discussions of goals of care with providers -- physicians, nurse practitioners, physician assistants or nursing home staff -- counted during follow-up|9 months||||Participants|||Count of Participants
1370257|NCT01565642|Secondary|Quality of Dying|Quality of Dying in Long-term Care (QOD-LTC) instrument has 11 items in 3 subscales measuring personhood, closure and preparation for dying, for total scores ranging 5-55. Higher scores indicate better quality of the dying experience.|9 months|Decedents only--this measure applies only to residents who die during Follow-Up.|||units on a scale||Standard Deviation|Mean
1370258|NCT01565642|Secondary|Alzheimer Disease Related Quality of Life|The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.|9 months|This measure applies only to those persons with dementia who remained alive through the 9 month follow-up. In addition there were 3 withdrawals from the study by 9 months. Thus the overall number of participants for this outcome measure are n=239 (n=302 after removal of 60 decedents and 3 withdrawn participants).|||units on a scale||Standard Deviation|Mean
1370259|NCT01565642|Secondary|Comfort in Dying|Comfort Assessment in Dying for Dementia (CAD-EOLD) includes 14 items rated on a 3 point scale, summed for a total potential score of 14-42. Higher scores indicate better comfort.|9 months|Decedents only--this outcome measure applies only to residents who die during Follow-Up.|||units on a scale||Standard Deviation|Mean
1370260|NCT01565642|Secondary|Satisfaction With Care|Satisfaction with Care at the End of Life in Dementia (SWC-EOLD) scale; 10 items rated 1-4 and summed with total potential range 10-40. Higher scores indicate better satisfaction.|9 months||||units on a scale||Standard Deviation|Mean
1370261|NCT01565642|Secondary|Number of Palliative Care Domains in Care Plan|Index score ranging from 0-10 with one point given for care plan addressing each domain: prognosis, goals of care, physical symptoms, emotional needs, spiritual needs, resuscitation, artificial feeding, intravenous fluids, antibiotics, hospitalization. Higher scores indicate better palliative care.|9 months||||units on a scale||Standard Deviation|Mean
1370262|NCT01565642|Primary|Quality of Communication and Decision-making|The Quality of Communication (QOC) score with its End of Life (EOL) subscale score. Scores range 0-10 on QOC and its subscales, with higher scores indicating better communication quality.|3 months||||units on a scale||Standard Deviation|Mean
1370263|NCT01565616|Post-Hoc|PROMIS-57 Scores Health Related Quality of Life|"Health related quality of life was measured with the 57 item Patient-Reported Outcomes Measurement Information System (PROMIS-57). The PROMIS-57 includes 8 domains of health. The domains of Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Satisfaction with Social Role, and Sleep Disturbances each include 8 items. Respondents indicate the degree to which statements about specific health issues are problematic on a scale of 1 to 5 and responses are converted to a t-score metric. A score of 50 is the mean score for the general population in the United States, with a standard deviation of 10. Scores above 50 indicate the topic of the domain is being experienced more than average while scores below 50 mean that it is less than average.~The domain of Pain Intensity is measured with a single item asking participants to rate their average pain on a scale from 0 (no pain) to 10 (worst imaginable pain). The raw mean score is used."|Baseline, 1 year after transplant|This outcome measure compared quality of life scores one year post-HCT to baseline in the 17 participants who completed the surveys.|||units on a scale||Standard Deviation|Mean
1370264|NCT01565616|Secondary|Transplant Related Outcomes|Common transplant related complications were monitored as a secondary outcome measure of this study. These transplant related complications include hepatic veno-occlusive disease (VOD), idiopathic pneumonia syndrome (IPS), central nervous system (CNS) toxicity complications of posterior reversible encephalopathy syndrome (PRES), hemorrhage, and seizures, cytomegalovirus (CMV) infection, adenovirus infection, Epstein-Barr virus (EBV) infection, post-transplant lymphoproliferative disease (PTLD), and invasive fungal infection.|1 year after transplant||||Participants|||Count of Participants
1370265|NCT01565616|Secondary|Time to Neutrophil and Platelet Engraftment|Time to neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of at least 500/µL after conditioning. Time to Platelet engraftment is defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count > 50,000/µL, without receiving a platelet transfusion in the previous 7 days.|1 year after transplant||||Days||Full Range|Median
1370266|NCT01565616|Secondary|Overall Survival|Overall survival is defined as survival with or without sickle cell disease after hematopoietic cell transplantation (HCT).|1 year after transplant||||Participants|||Count of Participants
1370267|NCT01565616|Secondary|Chronic Graft Versus Host Disease (GVHD)|Chronic GVHD was graded according to the National Institutes of Health (NIH) 2014 Consensus Criteria Diagnosis and scoring the severity of chronic GVHD is determined by evaluating symptoms of the skin, nails, hair, mouth, eyes, genitalia, gastrointestinal tract, liver, lungs, muscles, fascia and joints, immune function as well as other symptoms such as ascites and neuropathy. Chronic GVHD is graded as mild, moderate or severe based on the number of organ sites impacted and the severity of symptoms.|1 year after transplant||||Participants|||Count of Participants
1370268|NCT01565616|Secondary|Acute Graft Versus Host Disease (GVHD)|"Acute GVHD was graded according to the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus criteria. Clinical manifestations of acute GVHD include skin, liver, and gastrointestinal symptoms. Grading of acute GVHD is determined by size of maculopapular rash, bilirubin and stool output. Acute GVHD grades range from 0 to 4 with 0 indicating no GVHD and 4 representing the most severe grade.~Grade II is defined as a maculopapular rash over 25-50% of body surface area (BSA), bilirubin of 3.1 to 6 mg/dL, and stool output of 1000-1500 mL/d (for adults).~Grade III is defined as a maculopapular rash over more than 50% of BSA, bilirubin of 6.1 to 15 mg/dL, and stool output of greater than 1500 mL/d (for adults).~Grade IV is defined as generalized erythroderma with bullous formation, bilirubin greater than 15 mg/dL, and severe abdominal pain with or without ileus."|1 year after transplant||||Participants|||Count of Participants
1370269|NCT01565616|Secondary|Graft Failure|Primary graft failure occurs when a transplant recipient does not achieve donor chimerism following a bone marrow transplant. Secondary graft failure occurs when graft fails after donor chimerism had initially occurred.|1 year after transplant||||Participants|||Count of Participants
1370270|NCT01565616|Primary|Event -Free Survival Rate|Event-free survival is defined as stable donor erythropoiesis with no new clinical evidence of sickle cell disease. Primary or late graft rejection, disease recurrence, and death are considered events for this endpoint.|1 year after transplant||||Participants|||Count of Participants
1370271|NCT01565564|Secondary|The Rate of Pregnancy-induced Hypertension.|Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.|From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.||||participants|||Number
1370272|NCT01565564|Primary|The Rate of Macrosomia.|Macrosomia is defined as birthweight ≥ 4000 gram.|At the time of birth.||||participants|||Number
1370273|NCT01565551|Primary|Glasgow Outcome Scale Extended (GOSE)|The GOSE provides and overall measure of disability based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.|6 Months Post-Injury||||Glasgow Outcome Scale Extended (GOSE)||Inter-Quartile Range|Median
1370274|NCT01565538|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.||||months||95% Confidence Interval|Median
1370275|NCT01565538|Secondary|Best Tumor Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.||||participants|||Number
1370276|NCT01565538|Primary|Progression-Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.||||months||95% Confidence Interval|Median
1370277|NCT01565382|Secondary|Overall Inter-reader Agreement - Fleiss' Kappa|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.|||Fleiss' kappa|Participants||Number
1370278|NCT01565382|Primary|Inter-reader Agreement - Median Kappa Statistic|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.|||median kappa|Participants||Number
1370279|NCT01565369|Secondary|Inter-reader Agreement|Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers|50-60 min after injection|315 scans = 35 subjects x 9 readers|||percentage of scans|Participants||Number
1370373|NCT01564407|Secondary|Vancouver Scar Scale|Vancouver scar scale will be evaluated for each cohort. The Vancouver scar scale is the most frequently cited assessment of scar severity used in clinical studies. Pigmentation, vascularity, pliability, and scar height are graded producing a composite score. A score of 0 represents normal skin with higher grades representing greater deformity with a maximum possible rating of 14.|12 weeks||||scores on a scale||Standard Deviation|Mean
1370280|NCT01565369|Primary|Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.|50-60 min after injection|16 of the 35 subjects had none or sparse plaques at autopsy|||percentage of true negatives||Full Range|Median
1370281|NCT01565369|Primary|Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.|50-60 min after injection|19 of the 35 subjects had moderate or frequent plaques at autopsy|||percentage of true positives||Full Range|Median
1370282|NCT01565356|Secondary|Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.|Scans acquired 30-40 min and 50-60 min post-injection||||weighted kappa||95% Confidence Interval|Number
1370283|NCT01565356|Primary|Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.|Scans acquired 30-40 min and 50-60 min after injection||||percentage of agreement|||Number
1370284|NCT01565343|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-70 min after injection|Due to poor subject positioning that resulted in an incomplete brain image on the retest image day, accurate quantitative analysis for one healthy control was not possible, and the subject was excluded from the SUVR-based analyses.|||SUVR||Standard Deviation|Mean
1370285|NCT01565330|Secondary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|0-90 min after injection||||SUVR||Standard Deviation|Mean
1370286|NCT01565330|Primary|Florbetapir-PET Scan Quality|Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).|0-90 min after injection|One subject in the 370 MBq (10 mCi) AD Group did not complete all imaging time periods|||florbetapir scans|||Number
1370287|NCT01565291|Secondary|Precuneus to Cerebellum SUVR|Ratio of uptake in the precuneus to uptake in the cerebellum.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.|||SUVR||Standard Deviation|Mean
1370288|NCT01565291|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.|||SUVR||Standard Deviation|Mean
1370289|NCT01565148|Secondary|Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections|cmax|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
1370290|NCT01565148|Secondary|Duration of iCo-007 Treatment Effect|treatment effect as measured by VA and OCY thickness|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
1370291|NCT01565148|Secondary|Change in Retinal Thickness Measured|measured by OCT|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
1370292|NCT01565148|Secondary|Change in Retinal Thickness Measured by OCT From Baseline to Month 8|Group 1|Baseline to month 8|Some participants opted out of the month 8 OCT.|||microns||Standard Deviation|Mean
1370293|NCT01565148|Secondary|Change in VA From Baseline to Month 12|The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
1370294|NCT01565148|Secondary|Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability|Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation. Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;|Baseline to month 8||||Participants|||Count of Participants
1370295|NCT01565148|Primary|Change in VA From Baseline to Month 8|The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8|Baseline to month 8|The results are from the participants which completed the primary end point and for which the data is available.|||Letters||Standard Deviation|Mean
1370315|NCT01564862|Secondary|Change From Baseline to Week 8 in the MADRS Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.|Baseline, Week 1, Week 4 and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.|||score on a scale||Standard Deviation|Mean
1370296|NCT01565083|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score|FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
1370297|NCT01565083|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score|EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
1370298|NCT01565083|Secondary|Overall Survival (OS)|OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline until death (up to approximately 3.5 years)|ITT population|||months||95% Confidence Interval|Median
1370299|NCT01565083|Secondary|Percentage of Participants Who Died From Any Cause|Percentage of participants who died due to any cause was reported.|Baseline until death (up to approximately 3.5 years)|ITT population|||percentage of participants|||Number
1370300|NCT01565083|Secondary|Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1|TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||months||95% Confidence Interval|Median
1370301|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||percentage of participants|||Number
1370302|NCT01565083|Secondary|Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1|PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||months||95% Confidence Interval|Median
1370303|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||percentage of participants|||Number
1370337|NCT01564784|Primary|Overall Survival (OS)|OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.|Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.|ITT population - included all participants randomized. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Months||95% Confidence Interval|Median
1370304|NCT01565083|Secondary|Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1|DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with a BOR of CR or PR and with measurable disease at baseline were included in the analysis.|||months||95% Confidence Interval|Median
1370305|NCT01565083|Secondary|Time to Response as Assessed by Investigator According to RECIST v 1.1|For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.|||months||95% Confidence Interval|Median
1370306|NCT01565083|Primary|Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1370307|NCT01564953|Secondary|Quality of Life|Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test. Minimum score was 0 (no symptoms) and maximum score was 40 (many symptoms).|One year||||units on a scale||Full Range|Mean
1370308|NCT01564953|Secondary|Serum Calcium|Serum ionized calcium, in mmol/L|One year||||mmol/L||Standard Deviation|Mean
1370309|NCT01564953|Secondary|Serum Magnesium|Serum magnesium in plasma, in mmol/L|One year||||mmol/L||Standard Deviation|Mean
1370310|NCT01564953|Secondary|Lung Function Test|Forced expiratory ventilation in 1 second, in percent of predicted|one year||||percentage of predicted||Full Range|Mean
1370311|NCT01564953|Primary|Serum Vitamin D|vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L|one year||||mmol/L||Standard Deviation|Mean
1370312|NCT01564862|Secondary|Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline*week, center, week, treatment and week*treatment as factors was used for analyses."|Baseline, Week 1, Week 4 and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis. Repeated Measures Analysis.|||score on a scale||Standard Error|Least Squares Mean
1370313|NCT01564862|Secondary|Percentage of Participants in MADRS Remission at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10.|Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.|||percentage of participants|||Number
1370314|NCT01564862|Secondary|Percentage of Participants With MADRS Response at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.|||percentage of participants|||Number
1370316|NCT01564862|Secondary|Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression|Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient*MADRS difference).|Baseline and Week 8|Full Analysis Set included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment.|||proportion of direct effect|||Number
1370317|NCT01564862|Secondary|Change From Baseline to Week 8 in the One-Back Task|The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Log 10 milliseconds||Standard Error|Least Squares Mean
1370318|NCT01564862|Secondary|Change From Baseline to Week 8 in the Identification Task (IT)|The IT measured choice reaction time: the participant pressed a “yes” button whenever an onscreen playing card turned face up and was red, or a “no” button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Log10 milliseconds||Standard Error|Least Squares Mean
1370319|NCT01564862|Secondary|Change From Baseline to Week 8 in the Detection Task (DT)|"The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a yes button as soon as an onscreen playing card is turned over and is red, and by pressing a no button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Log10 milliseconds||Standard Error|Least Squares Mean
1370320|NCT01564862|Secondary|Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT)|"The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function.~An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Errors||Standard Error|Least Squares Mean
1370321|NCT01564862|Secondary|Change in Time From Baseline to Week 8 in the Stroop Test|The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||seconds||Standard Deviation|Mean
1370322|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test B (TMT-B)|The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||seconds||Standard Error|Least Squares Mean
1370353|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)|The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||2020-12-31|12/2020||||
1370323|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test (TMT-A)|The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||seconds||Standard Error|Least Squares Mean
1370324|NCT01564862|Secondary|Clinical Global Impressions-Improvement (CGI-I) Score at Week 8|"The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis."|Baseline, Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1370325|NCT01564862|Secondary|Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore|PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1370326|NCT01564862|Primary|Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)|The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Participants with scores of > 70 at Baseline were excluded.|||Correct symbols||Standard Error|Least Squares Mean
1370327|NCT01564784|Secondary|Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT|VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.|Up to 2 years from randomization|Participants in the Safety population with post-study HSCT. A site visit in July 2017 (after clinical database lock), confirmed a fourth case of VOD/SOS occurred in the Defined Investigators Choice of Chemotherapy arm in March 2013 (approximately 3 months after the last dose).This was not entered on the CRF and therefore, is not included below.|||Percentage of Participants|||Number
1370328|NCT01564784|Secondary|Change From Baseline in EQ-5D VAS|The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants’ health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting “no problems”, “some problems”, and “extreme problems”. The EQ-VAS records the respondent’s self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Day 1 of each cycle prior to dosing and EoT|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Score on a scale||Standard Error|Mean
1370371|NCT01564407|Secondary|Disability Index-Disability of Arm, Shoulder and Hand|The six subjects suffering from upper extremity and cervical scar contractures were evaluated with the Disability of Arm, Shoulder and Hand (DASH) questionnaire. The DASH questionnaire evaluates symptoms and functional status. A lowest score of 0 indicates normal skin and highest score of 100 represents the greatest possible morbidity.|12 weeks||||scores on a scale||Standard Deviation|Mean
1370374|NCT01564407|Secondary|Percentage of Subjects Worse Hypertrophic Scars|The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.|Endpoints assessed at Day 84.||||percentage of paricipants|||Number
1370329|NCT01564784|Secondary|Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score|The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants’ health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting “no problems”, “some problems”, and “extreme problems”. The EQ-VAS records the respondent’s self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Day 1 of each cycle prior to dosing and EoT|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Score on a scale||Standard Error|Mean
1370330|NCT01564784|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score|This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.|Day 1 of each cycle prior to dosing and EoT|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population|||Score on a scale||Standard Error|Mean
1370331|NCT01564784|Secondary|Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing|Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).|Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4|Pharmacokinetic (PK) evaluable population - included all participants with available PK data.|||ng/mL||Standard Deviation|Mean
1370332|NCT01564784|Secondary|Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)|Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.|Up to approximately 4 weeks (EoT) from last dose of study drug|Participants in the ITT218 population who had abnormal cytogenetics at baseline and who achieved CR/CRi|||Percentage of Participants||95% Confidence Interval|Number
1370333|NCT01564784|Secondary|Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)|MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells.|Up to approximately 4 weeks (EoT) from last dose of study drug|Participants in the ITT218 population achieving CR/CRi (per EAC Assessment)|||Percentage of Participants||95% Confidence Interval|Number
1370334|NCT01564784|Secondary|Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)|HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.|Up to 19 weeks from last dose|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Percentage of Participants||95% Confidence Interval|Number
1370335|NCT01564784|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan–Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.|Up to 2 years from randomization|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Months||95% Confidence Interval|Median
1370336|NCT01564784|Secondary|Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)|DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.|Up to 2 years from randomization|Participants in the ITT218 population who achieved CR/CRi|||Months||95% Confidence Interval|Median
1370338|NCT01564784|Primary|Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)|CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL.|Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose|ITT218 population - included the ITT population (all participants randomized) for the initial 218 participants.|||Percentage of Participants||95% Confidence Interval|Number
1370339|NCT01564758|Secondary|Number of Participants With Clinical Response|Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.|EOT (Day 10 up to 28)|Efficacy was evaluated for the safety analysis set which included all the participants who received at least 1 dose of study medication|||participants|||Number
1370340|NCT01564758|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to End of Treatment (EOT) (Day 10 up to 28)|Safety analysis set included all the participants who received at least 1 dose of study medication.|||participants|||Number
1370341|NCT01564732|Secondary|Quantitative Change in Hypertriglyceridemia|Triglyceride levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.|36 months|Data not collected.||||||
1370342|NCT01564732|Secondary|Quantitative Change in Hyperlipidemia|Lipid levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.|36 months|Data not collected.||||||
1370343|NCT01564732|Secondary|Quantitative Change in Diabetes|Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.|36 months|Data not collected||||||
1370344|NCT01564732|Secondary|Quantitative Change in Hypertension|Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.|36 months|Data not collected.||||||
1370345|NCT01564732|Secondary|Quality of Life||36 months|data not collected||||||
1370346|NCT01564732|Primary|Weight Loss||36 months|Data not collected.||||||
1370347|NCT01564706|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.|0-380 min after injection||||mSv/MBq||Standard Deviation|Mean
1370348|NCT01564693|Primary|ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE|We observed different BOLD signal in the region of the hypothalamus between the 3 groups. The BOLD signal and the activation/no activation areas were statistically analyzed by a specific statistical method (i.e., parametric mapping).|TIME 0 (BASELINE)||||BOLD||Standard Deviation|Mean
1370349|NCT01564537|Secondary|Association Between Response or Resistance to Ixazomib Treatment and Proteasome and Nuclear Factor–kB (NF-kB)-Related Genes||At the time of screening; Day 1 of each cycle; at EOT; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||2020-12-31|12/2020||||
1370350|NCT01564537|Secondary|Pharmacokinetic Parameters (Including Cmax, AUC and Tmax) of Ixazomib||Days 1 & 14 of Cycles 1 & 2. Day 1 of Cycles 3 to 10||2020-12-31|12/2020||||
1370351|NCT01564537|Secondary|PFS in High-Risk Participants|Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis.|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Participants from the ITT population, all randomized participants, with cytogenic abnormalities.|||months||95% Confidence Interval|Median
1370352|NCT01564537|Secondary|OS in High-Risk Participants|Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||2020-12-31|12/2020||||
1370354|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||2020-12-31|12/2020||||
1370355|NCT01564537|Secondary|Percentage of Participants Achieving Pain Response|Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity (“worst,” “least,” “average,” and “now” [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst).|At screening; Day 1 of each cycle; and thereafter every 4 weeks until disease progression||2020-12-31|12/2020||||
1370356|NCT01564537|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|From the date of signing of the informed consent form through 30 days after the last dose of study drug up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Safety population included all randomized participants who received at least 1 dose of ixazomib.|||participants|||Number
1370357|NCT01564537|Secondary|Time to Progression (TTP) as Assessed by the IRC|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants|||months||95% Confidence Interval|Median
1370358|NCT01564537|Secondary|Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment, all responders.|||months||95% Confidence Interval|Median
1370359|NCT01564537|Secondary|Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) as Assessed by the IRC|Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.|||percentage of participants|||Number
1370360|NCT01564537|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.|||percentage of participants|||Number
1370361|NCT01564537|Secondary|Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]|Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle (every 4 weeks) until disease progression and thereafter every 12 weeks until death or study termination||2020-12-31|12/2020||||
1370362|NCT01564537|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|Date of randomization until death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population was defined as all randomized participants.|||months||95% Confidence Interval|Median
1370372|NCT01564407|Secondary|Patient and Observer Scar Assessment Scale (POSAS)|POSAS aims to measure scar quality, it is a comprehensive scale designed for the evaluation of all types of scars by professionals and patients. It contains two scales with six items, scored numerically from 0-10, where 0 is normal skin and 10 is the worst scar imaginable. the total scoring range is from 0-120.|12 weeks||||scores on a scale||Standard Deviation|Mean
1370363|NCT01564537|Primary|Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed.|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Intent-to-Treat (ITT) population was defined as all randomized participants.|||months||95% Confidence Interval|Median
1370364|NCT01564459|Primary|Percentage of Participants Who Were Discontinued Form the Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.|up to 7 days for run-in; up to 14 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.|||Percentage of Participants|||Number
1370365|NCT01564459|Primary|Percentage of Participants Who Experienced 1 or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.|up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.|||Percentage of Participants|||Number
1370366|NCT01564459|Secondary|Change in Pain Intensity Scores - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant’s average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1370367|NCT01564459|Secondary|Change in Pain Intensity Scores - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant’s average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the primary responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1370368|NCT01564459|Secondary|TTEF - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥20% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.|||Days||95% Confidence Interval|Median
1370369|NCT01564459|Primary|Time to Efficacy Failure (TTEF) - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant’s average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.|||Days||95% Confidence Interval|Median
1370370|NCT01564407|Secondary|Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)|SWAP is a psychological test for personality diagnosis. there are 9 questions evaluated by a score of 7 (most descriptive to the patient) to 0 (not descriptive or irrelevant) for a total scoring range of 0-63.|12 weeks||||units on a scale||Standard Deviation|Mean
1370376|NCT01564407|Primary|Number of Participants With Adverse Events|The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.|Days 0, 7, 14, 28, 56, 84||||participants|||Number
1370377|NCT01564394|Primary|FACIT-Fatigue Change From Baseline to 13-weeks.|Our primary outcome of change in fatigue was assessed with the Functional Assessment Chronic Illness Therapy (FACIT)-Fatigue scale. This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .|||Units on scale||Inter-Quartile Range|Median
1370378|NCT01564394|Primary|Attendance Rates in Study (Feasibility Outcome)|The class attendance rates were the number of classes attended by participants divided by the total number of classes offered. Range of attendance rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks||||Proportion of classes|||Number
1370379|NCT01564394|Primary|Retention Rate in Study (Feasibility Outcome)|The retention rate was the proportion of participants who remained enrolled in the study and completed post-intervention measures. Range of retention rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks||||proportion of participants|||Number
1370380|NCT01564394|Secondary|Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks|The BSI-18 assesses global distress and three subscales (anxiety, depression, & somatization). Scores are converted to T-scores based on US population norms. Negative change scores indicate improvement in distress. We report data separately for prostate cancer survivors and family members. Based on the population norm a T-score of 63 or above indicates heightened global distress.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .|||T-Score||Inter-Quartile Range|Median
1370381|NCT01564277|Secondary|Number of Patients Experiencing a Doubling of Serum Creatinine|Count of participants experiencing a doubling of serum creatinine|up to day 6|All treated and eligible patients|||Participants|||Count of Participants
1370382|NCT01564277|Secondary|Safety of Low Single-doses of Rasburicase.|The number of patients with any adverse events .|up to day 7|All treated and eligible patients|||Participants|||Count of Participants
1370383|NCT01564277|Secondary|Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7|The mean area under the plasma uric acid concentration-time curve (AUC) from baseline (Day 1) to Day 7|Up to day 7|All treated and eligible patients|||days*mg/dL||Standard Deviation|Mean
1370384|NCT01564277|Secondary|Baseline White Blood Cell Count by Response|The mean baseline white blood cell count of patients with a complete response (CR) (patients who achieved uric acid level =< 7.5mg/dL) and no CR (patients with uric acid level > 7.5mg/dL).|Up to day 7|All treated and eligible patients|||cells x 10^9/L||Standard Deviation|Mean
1370385|NCT01564277|Secondary|Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL|Count of partcicpants requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL by treatment arm.|Up to day 7|All treated and eligible patients|||Participants|||Count of Participants
1370386|NCT01564277|Primary|Probability of Obtaining a Uric Acid Level =< 7.5mg/dL|The proportion of patients able to achieve and/or maintain a uric acid level =< 7.5mg/dL for each treatment arm.|Within 24 hours of rasburicase treatment|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
1370387|NCT01563978|Secondary|DAS28-CRP Improvement|ANCOVA=analysis of covariance, BID=twice daily, DAS28-CRP=Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (C-reactive protein [CRP]) and the patient’s own assessment, FAS=full analysis set, IP=investigational product. Scores can take any positive value with a lower value indicative of a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicating a better clinical condition.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes those patients from the FAS who were still on IP at 4 weeks and had a valid measurement for this type of assessment.|||Units on a scale||Standard Deviation|Mean
1370388|NCT01563978|Secondary|Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP|BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|Day 29 to Day 36|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes patients from the FAS still on IP at Day 36 and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370389|NCT01563978|Secondary|Mean Change From Baseline in Evening Post-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370618|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370390|NCT01563978|Secondary|Mean Change From Baseline in Morning Pre-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370391|NCT01563978|Secondary|Mean Change From Baseline in Clinic SBP and DBP|Blood pressure was measured in the clinic using an automated blood pressure machine (oscillometric method). Three separate measurements were taken 2 to 5 minutes apart and the mean of the 2nd and 3rd measurements calculated. ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370392|NCT01563978|Secondary|Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370393|NCT01563978|Secondary|Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370394|NCT01563978|Secondary|Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370395|NCT01563978|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and had a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370396|NCT01563978|Primary|Change From Baseline in 24-hour Mean Ambulatory SBP|ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
1370397|NCT01563913|Secondary|Forceplate Measured Dyskinesia|Dyskinesia are abnormal movements caused by levodopa. These abnormal movements will be measured with a forceplate (a device that is similar to a door mat). Dyskinesia will be examined at all inpatient visits and area under the curves will be compared with a clinical rating scale to measure the development of dyskinesia after starting levodopa therapy.|baseline and 1.5 years|Docosahexaenoic Acid Arm: 2 participants withdrew after the 6 week visit, 4 didn't complete visit 5 due to: wife's death, too busy, new diagnosis of cancer.|||Participants|||Count of Participants
1370398|NCT01563913|Primary|Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC)|This study is seeking to determine the safety/efficacy of DHA in Parkinson's disease patients. The safety/efficacy of DHA will be determined using periodic safety lab information. Safety labs for complete blood count (CBC) were performed at each inpatient visit, reviewed by the PI, and marked as normal or abnormal.|Year 1|3 participants did not complete year 1 visit (2 withdrew prior to year 1, 1 refused to travel for visit), 2 blood samples were hemolyzed and could not be analyzed.|||Participants|||Count of Participants
1370399|NCT01563913|Primary|Efficacy of DHA - Change in Blood ng/dL Levels|Therapeutic level monitoring will be accomplished by analyzing blood levels for DHA.|baseline and 1.5 years||||ng/dL - Blood||Standard Deviation|Mean
1370400|NCT01563536|Other Pre-specified|Resistance-Associated Variants and Phenotypic Resistance|Baseline (pre-dose on Day 1) samples were analyzed for resistance-associated amino acid (AA) variants using population sequencing. Phenotypic resistance to ABT-267 at Baseline was assessed by calculating the fold difference in the the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Day 3 samples were analyzed using population sequencing and were compared with the baseline and appropriate prototypic reference sequences to assess AA changes. Phenotypic resistance at Day 3 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding Baseline sample. The number of participants with variants at resistance-associated AA positions and phenotypic resistance at Baseline and Day 3 are presented.|Day 1 Pre-dose (Baseline) and Day 3 Pre-dose|All participants who received at least one dose of study drug (ITT population) and had evaluable data were analyzed for baseline resistance-associated amino acid variants; the development of viral resistance was analyzed in all participants who received at least 1 dose of ABT-267 whose samples had sufficient viral titer to allow analysis.|||participants|||Number
1370401|NCT01563536|Primary|Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy|The baseline value was the last measurement before the first dose of ABT-267 monotherapy (Day 1). The maximal decrease during monotherapy was the change from baseline to the lowest log10 IU/mL HCV RNA level any time from the first dose of ABT-267 on Day 1 to the last log10 HCV RNA level before the first dose of ABT-267 combination therapy (Study Day 3).|Pre-dose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).|||log10 IU/mL||Standard Error|Least Squares Mean
1370402|NCT01563536|Secondary|Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy|The relationship between ABT-267 dose, ABT-267 concentration, and response was analyzed as the change in viral load (measured as log10 IU/mL) from baseline (pre-dose on Day 1) to pre-dose on Days 2 and 3. Plasma concentrations of ABT-267 pre-dose on Days 2 and 3 are presented above in 4. Primary Outcome: Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3.|Predose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).|||log10 IU/mL||Standard Deviation|Mean
1370403|NCT01563536|Secondary|Percentage of Participants With Extended Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at Weeks 4 through 12 of combination therapy.|Weeks 4 to 12|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1370404|NCT01563536|Secondary|Percentage of Participants With End-of-Treatment Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at the end of combination therapy (12 weeks).|12 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1370405|NCT01563536|Secondary|Percentage of Participants With Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) after 4 weeks of combination therapy.|4 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1370406|NCT01563536|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 and 24 weeks after the last dose of combination study drug. The LLOQ for the assay was 25 IU/mL.|12 and 24 weeks after last dose of combination study drug|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1370407|NCT01563536|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs), and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks).|All participants who received at least one dose of study drug (safety population).|||participants|||Number
1370408|NCT01563536|Primary|Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3|Blood samples were collected pre-dose on Day 2 (prior to second dose of ABT-267 monotherapy) and pre-dose on Day 3 (prior to first dose of combination therapy). The samples were analyzed for ABT-267 using validated analytical methods. Pre-dose plasma concentrations on Day 2 and Day 3 (Ctrough, measured in ng/mL) are reported.|Day 2 (pre-dose) and Day 3 (pre-dose)|All participants who received at least one dose of study drug (ITT population).|||ng/mL||Standard Deviation|Mean
1370409|NCT01563536|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[24]; measured in ng multiplied by hour/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).|||ng*hr/mL||Standard Deviation|Mean
1370410|NCT01563536|Primary|Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Time of maximum plasma concentration (Tmax; measured in hours) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).|||hours||Standard Deviation|Mean
1370411|NCT01563536|Primary|Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (intent-to-treat [ITT] population).|||ng/mL||Standard Deviation|Mean
1370412|NCT01563406|Secondary|Median Number of Microbial Colony Forming Units Per Hub Interior|This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.|15 months||||colony forming units (CFU) per hub|Participants|Inter-Quartile Range|Median
1370414|NCT01563406|Primary|Number of Central Venous Catheter Hubs With Internal Contamination|"This will be a qualitative outcome. It will be reported as yes or no for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms."|15 months|140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.|||contaminated hubs|Participants||Number
1370415|NCT01563198|Secondary|Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training|The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year.|Baseline average of one year plus post training average one year = 2 years|Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included.|||Percentage of participants|||Number
1370416|NCT01563198|Primary|Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only)|The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed|Baseline average of one year plus post training average one year = 2 years|Participants were from 3 MRI sites whose teams were trained in Comfort Talk®. In this analysis only patients who showed up at the MRI sites at baseline year and the year after training were included (all participants minus no-shows).|||Percentage of showing-up participants|||Number
1370417|NCT01563198|Primary|Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients)|The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion among all scheduled patients.|Baseline average of one year plus post training average one year = 2 years|Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included|||Percentage of participants|||Number
1370418|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Volume Distribution (V/F)|V/F were estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group||||L/70 kg||Standard Deviation|Mean
1370419|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Individual Oral Clearance (CL/F)|CL/F was estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable and all 9 were in the multiple dose pharmacokinetic group).|||L/h/70 kg||Standard Deviation|Mean
1370420|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUC(0-t))|AUC(0-t) was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average AUC values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 patient was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).|||ug*h/mL||Standard Deviation|Mean
1370421|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Maximum Observed Concentration (Cmax)|Cmax was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average Cmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).|||ug/mL||Standard Deviation|Mean
1370422|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Time of Maximum Observed Concentration (Tmax)|Tmax was estimated for ibuprofen and famotidine.The PK parameters for ibuprofen and famotidine represent average Tmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).|||hours||Standard Deviation|Mean
1370423|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Serum C Reactive Protein (CRP) Concentration|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CRP Concentration. This ACR value represents the average change in Serum C Reactive Protein (CRP) Concentration from the baseline visit to the week 24/ET visit. The normal range referenced was 0 mg/L - 4.99 mg/L.|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||mg/L||Standard Error|Mean
1370424|NCT01563185|Secondary|ACR Pediatric Components by Time Point: Number of Joints With Active Arthritis and the Number of Joints With Limited Range of Motion Number of Joints With Active Arthritis|"The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: number of joints with active arthritis and the number of joints with limited range of motion. These ACR values represent the average change in number of joints with active arthritis and the number of joints with limited range of motion from the baseline visit to the week 24/ET visit.~The joints that were assessed include the right and left temporomandibular, sternoclavicular, arcomiclavicular, shoulder, elbow, wrist, MCP - 1. MCP - 2, MCP - 3, MCP - 4, MCP - 5, PIP - 1, PIP - 2, PIP - 3, PIP - 4, PIP - 5, DIP - 1, DIP - 2, DIP - 3, DIP - 4, and DIP - 5."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||Number of joints||Standard Error|Mean
1370425|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: CHAQ - Disability Index|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CHAQ - Disability Index. This ACR measurement represents the average change in the Childhood Health Assessment Questionnaire (CHAQ) - Disability Index from the baseline visit to the week 24/ET visit. The CHAQ disability index is measured on a scale of 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||units on a scale||Standard Error|Mean
1370426|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Physician's Global Assessment of Disease Activity and Parent's Assessment of Overall Well-being|The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: the physician's global assessment of disease activity and the parent's global assessment of overall well-being. These ACR values represent the average change in the physician's global assessment of disease activity and the parent's global assessment of overall well-being from the baseline visit to the week 24/ET visit. The ACR pediatric core measure: Physician's global assessment of disease activity and parent's assessment of overall well being was measured on a scale of 0-100 mm (0 = very good, 100=very poor).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||units on a scale||Standard Error|Mean
1370427|NCT01563185|Secondary|Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores|"To assess patient quality of life while on study medication, the CHQ was administered to the patients' parent or guardian on Day 0 and at the Week 24/ET visit. The raw scale scores were transformed into scores on a 0 to 100 scale, 100 indicating best health and 0 indicating worst health. The algorithm is:~Transformed Score = ((Actual Raw Score - Lowest Possible Raw Score)/(Possible Raw Score Range)) x100. The actual raw score is the mean of the item responses in a scale (sum of item responses/number of completed items). The possible raw score range is the highest possible raw score minus the lowest possible raw score. The outcome measure data table shows the average change in the CHQ concepts from Baseline to the week 24 visit. The average change in the CHQ concepts is on a -100 to 100 scale, -100 representing a negative change in health and 100 indicating a positive change in health."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||units on a scale||Standard Deviation|Mean
1370428|NCT01563185|Primary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs)|Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.|Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)||||participants|||Number
1370429|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
1370430|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
1370431|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
1370432|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
1370433|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||micrograms (μg)×F/centimeters(cm)2||Standard Error|Least Squares Mean
1370592|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370434|NCT01563172|Secondary|Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
1370435|NCT01563172|Secondary|Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
1370436|NCT01563172|Secondary|Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
1370437|NCT01563172|Secondary|Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
1370438|NCT01563172|Primary|Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|Per Protocol (PP) population: Included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
1370439|NCT01563081|Secondary|Cmax and Cmin of Levocetirizine in Plasma|Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the >=6 months and <12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the >=12 months and <24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa.|Weeks 1 and 2/Early Withdrawal|Pharmacokinetic Concentration Population: all participants who underwent blood sampling, who provided data at the time of the last dose and the time of blood sampling, and who provided valid drug concentrations|||nanograms per milliliter||Full Range|Median
1370440|NCT01563081|Secondary|Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal|The investigator comprehensively assessed the pariticipant’s severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none.|First day of treatment; Weeks 1 and 2/Early Withdrawal|FAS. Only those participants with pruritis associated with skin diseases at Baseline were assessed for pruritis severity.|||participants|||Number
1370647|NCT01562327|Secondary|Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||participants|||Number
1370441|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator|The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened.|First day of treatment; Weeks 1 and 2/Early Withdrawal|"FAS. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2/Early Withdrawal. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."|||participants|||Number
1370442|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression|"The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."|First day of treatment; Weeks 1 and 2/Early Withdrawal|Full Analysis Set (FAS): all participants, excluding those with any major good clinical practice deviation, those who did not meet the primary criteria for enrollment, those who received no dose of study medication, and those with no data after supply of the investigational product|||participants|||Number
1370443|NCT01563081|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)|A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of >=5%, please see the SAE/non-serious AE module of this record.|up to Week 2/Early Withdrawal (EW)|Safety Population : all participants who participated in this study and who received at least one dose of medication|||participants|||Number
1370444|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
1370445|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
1370446|NCT01563055|Secondary|Cmax/D for Phenyl Acetic Acid Mustard|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
1370447|NCT01563055|Secondary|Dose Normalized Cmax (Cmax/D) for Chlorambucil|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
1370448|NCT01563055|Secondary|AUC (0-t) of Phenyl Acetic Acid Mustard|AUC (0-t) represents the area under the concentration curve of phenyl acetic acid mustard in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1370648|NCT01562327|Secondary|Reason for DMARDs Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.|||participants|||Number
1370449|NCT01563055|Secondary|AUC (0-t) of Chlorambucil|AUC (0-t) represents the area under the concentration curve of chlorambucil in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1370450|NCT01563055|Secondary|AUC (0-t) of Ofatumumab|AUC (0-t) represents the area under the concentration curve of ofatumumab in plasma from 0 to time t hours. AUC (0-t) was assessed at 168 hours and 672 hours post-dose.|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
1370451|NCT01563055|Secondary|%AUC_extrap of Phenyl Acetic Acid Mustard|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
1370452|NCT01563055|Secondary|%AUC_extrap of Chlorambucil|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
1370453|NCT01563055|Secondary|%AUC_extrap of Ofatumumab|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
1370454|NCT01563055|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil|Vz/F of chlorambucil is defined as the apparent volume of distribution during terminal phase after non-intravenous (oral) administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||L/m^2||95% Confidence Interval|Geometric Mean
1370455|NCT01563055|Secondary|Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil|CL/F is defined as the apparent total clearance of the drug from plasma after oral administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||L/hr/m^2||95% Confidence Interval|Geometric Mean
1370456|NCT01563055|Secondary|Volume of Distribution (Vz) of Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||mL||95% Confidence Interval|Geometric Mean
1370457|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard|MRTinf is the average amount of time that phenyl acetic acid mustard spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
1370458|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Chlorambucil|MRTinf is the average amount of time that chlorambucil spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
1370459|NCT01563055|Secondary|Mean Residence Time to Infinity (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||hours||95% Confidence Interval|Geometric Mean
1370649|NCT01562327|Secondary|Percentage of Participants Who Previously Received DMARDs||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
1370460|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
1370461|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Chlorambucil|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
1370462|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Ofatumumab|Tmax is the time required for reaching maximum concentration of drug (Cmax). Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
1370463|NCT01563055|Secondary|Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard|t1/2 is the time required for the plasma/serum concentration of phenylacetic acid mustard to decrease by half. Blood samples for serum concentration of phenylacetic acid mustard was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population|||hours||95% Confidence Interval|Geometric Mean
1370464|NCT01563055|Secondary|Plasma Half-life (t1/2) of Chlorambucil|t1/2 is the time required for the serum concentration of chlorambucil to decrease by half. Blood samples for serum concentration of chlorambucil was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
1370465|NCT01563055|Secondary|Plasma Half-life (t1/2) of Ofatumumab|t1/2 is the time required for the plasma concentration of ofatumumab to decrease by half. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
1370466|NCT01563055|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||mL||95% Confidence Interval|Geometric Mean
1370467|NCT01563055|Secondary|AUC(0-infinity) for Phenyl Acetic Acid Mustard|The total AUC or AUC(0-infinity) is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
1370468|NCT01563055|Secondary|AUC(0-infinity) for Chlorambucil|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
1370469|NCT01563055|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed on Cycle 1-Day 1. The samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||Hr*ug/mL||95% Confidence Interval|Geometric Mean
1370479|NCT01563055|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Maximum (peak) plasma drug concentration of ofatumumab was determined at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1370470|NCT01563055|Secondary|AUC(0-tau) of Phenyl Acetic Acid Mustard|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
1370471|NCT01563055|Secondary|AUC(0-tau) of Chlorambucil|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
1370472|NCT01563055|Secondary|Area Under the Drug Plasma Concentration-time Curve From Dosing to Time Tau (AUC[0-tau]) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. For ofatumumab it was assesed at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hours*nanogram/milliliter (hr*ng/mL||95% Confidence Interval|Geometric Mean
1370473|NCT01563055|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||Milliliters/hour (mL/hr)||95% Confidence Interval|Geometric Mean
1370474|NCT01563055|Secondary|Cmin of Phenyl Acetic Acid Mustard|Cmin of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Geometric Mean
1370475|NCT01563055|Secondary|Cmin of Chlorambucil|Cmin of chlorambucil was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Mean
1370476|NCT01563055|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Minimum plasma drug concentration of ofatumumab was determined at Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), Cycle 2-Day 29 (pre-dose), Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr), Cycle 4-Day 85 (pre-dose, 30 min post end of infusion), Cycle 5-Day 113 (pre-dose and end of infusion) and Cycle 6-Day 141 (pre-dose and end of infusion).|Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1370477|NCT01563055|Secondary|Cmax of Serum Phenyl Acetic Acid Mustard|Cmax of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Geometric Mean
1370478|NCT01563055|Secondary|Cmax of Serum Chlorambucil|Cmax of serum chlorambucil was assesed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Geometric Mean
1370650|NCT01562327|Secondary|Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||participants|||Number
1370480|NCT01563055|Secondary|Complement (CH50) at Cycle 1-Day 1 and Cycle 4-Day 85|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation. Peripheral blood samples were collected for analysis at Cycle 1-Day 1 and Cycle 4-Day 85.|Cycle 1-Day 1 and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects pPopulation.|||Kilo units per liter (KU/L)||Standard Deviation|Mean
1370481|NCT01563055|Secondary|Beta-2 Microglobulin at Cycle 1-Day 1|Beta-2-microglobulin is a protein present on the surface of most cells. Higher levels indicate a poor prognosis of CLL. Beta-2 microglobulin was measured at Cycle 1-Day 1.|Cycle 1-Day 1|All Subjects Population|||Nanomoles per liter (NMOL/L)||Standard Deviation|Mean
1370482|NCT01563055|Secondary|Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted in peripheral blood by flow cytometry. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. B-cell monitoring (CD5+CD19+ and CD5-CD19+) was performed at Cycle 1 (Day 1, Day 15) and Cycle 2 (Day 29, Day 43), on Day 1 of Cycle 3, 4, 5, 6, 9 and 12 (Day 57, Day 85, Day 113, Day 141, Day 225, Day 309), 28 days after the first day of the last treatment cycle (FU 1-PDFU 1) for all participants depending on the number of cycles administered, and 84 and 168 days after the day of FU 1-PDFU 1 for participants in CR, PR, and SD.|Baseline, C1-D15, C2-D29, C2-D43, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Cells per microliter||Standard Deviation|Mean
1370483|NCT01563055|Secondary|Number of Participants Who Were Positive or Negative for Minimal Residual Disease (MRD), as Assessed by IRC With CT|MRD refers to small number of leukemic cells that remain in the participant's body during treatment or after treatment in participants who achieved a confirmed complete remission. MRD assessment in bone marrow aspiration sample was perfrmed by flow cytometry (cluster of differentiation [CD]5, CD19, CD20, CD23). The absence of MRD was defined as less than one CLL cell per 10,000 leukocytes. The number of participants who were positive and negative for MRD are presented.|FU 85-PDFU 85 (84 days after FU-1)|All Subjects Population. Only those participants who were positive and negative for MRD were analyzed.|||Participants|||Number
1370484|NCT01563055|Secondary|Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Immunoglobulins were measured at Cycle 1-Day 1, FU 1-PDFU 1, and FU 169-PDFU 169 for participants in CR, PR, and stable disease (SD).|Baseline (Cycle 1-Day 1), FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Grams per liter||Standard Deviation|Mean
1370485|NCT01563055|Secondary|Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points|HAHA are indicators of immunogenicity induced by ofatumumab. Blood samples were taken from participants at Screening, Cycle 4-Day 85, FU 1-PDFU 1, and FU 169-PDFU 169. The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. The results are presented as participants with HAHA results as positive, negative or confirmation required.|Screening, Cycle 4-Day 85, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
1370486|NCT01563055|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events|"Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Participants with Grade (G)3 or G4 adverse event of infection and myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Also presented are number of participants with autoimmune hemolytic anemia (AIHA). AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells."|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population|||Participants|||Number
1370487|NCT01563055|Secondary|Number of Participants With AEs of Maximum Severity|Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population|||Participants|||Number
1370538|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who receive at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1370488|NCT01563055|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population|||Participants|||Number
1370489|NCT01563055|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from Baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was the last pre-dose assessment performed on Cycle 1-Day 1(C1-D1). When C1-D1 was missing, the last assessment performed prior to pre-dose C1-D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Participants|||Number
1370490|NCT01563055|Secondary|Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points|The number of participants with no B-symptoms (no night sweat [without signs of infection], no unexplained, unintentional weight loss >= 10% within the previous 6 months, no recurrent, unexplained fever of greater than 38 degrees celcius for 2 weeks and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at Cycle (C) 1-Day (D) 1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
1370491|NCT01563055|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From start of treatment until the first administration of the next CLL therapy (up to Week 62.3)|All Subjects Population. Only those participants who received next CLL therapy were evaluated.|||Weeks||95% Confidence Interval|Median
1370492|NCT01563055|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the first documented evidence of CR, CRi, nPR or PR until the first documented sign of PD or death in participants with CR, CRi, nPR or PR. For participants who did not progress or die, duration of response was censored on the date of last assessment.|From initial response (CR/CRi/nPR/PR) until disease progression or death (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.|||Weeks||95% Confidence Interval|Median
1370493|NCT01563055|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from start of treatment until the first response (CR/CRi/nPR/PR). Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. This analysis only included participants who had a response while in the study, there was no censoring.|From start of treatment until the first response (CR/CRi/nPR/PR) (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.|||Weeks||95% Confidence Interval|Median
1370494|NCT01563055|Secondary|Overall Survival|Overall survival is defined as time from start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of the last date of contact.|From start of treatment until death (up to Week 62.3|All Subjects Population|||Weeks||95% Confidence Interval|Median
1370495|NCT01563055|Secondary|Progression-free Survival (PFS), as Assessed by the IRC and the Investigator|Progression free survival is defined as the time from start of treatment until disease progression (PD) or death due to any cause. PD was determined by the IRC or investigator according to the definitions of response in the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 per microliter B-lymphocytes; transformation to a more aggressive histology; or occurrence of cytopenia attributable to chronic lymphocytic leukemia. PFS was censored at the last visit with adequate assessment for participants who were alive and had not progressed.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population. Only participants who progressed or died were analyzed.|||Weeks||95% Confidence Interval|Median
1370708|NCT01561755|Secondary|Hughes Function Score|0 = Normal strength; 1 = minor symptoms but capable of running; 2 = The subject is able to walk 30 ft. but unable to run; 3 = The subject is able to walk 30 ft. with the assistance of one person; 4 = A walker or cane; 5 = The subject is unable to walk.|at 2 months||||units on a scale||Full Range|Mean
1370496|NCT01563055|Secondary|Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, CR (all the criteria at least 2 months after last treatment): peripheral blood lymphocytes below < 4,000/μL, no Ly > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; Neu >1500 /µL, PL >100,000/µL, Hb >11 g/dL, BM sample must be normocellular for age, <30% lymphocytes, no LN. PR: >=50% decrease in peripheral blood lymphocytes, Ly, size of liver and spleen; and blood count showing at least one of the following results: Neu>1500/μL, PL >100,000/µL or 50% improvement over BL, Hb >11 g/dL or 50% improvement over BL. No increase in LN and no new LN.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population|||Participants|||Number
1370497|NCT01563055|Primary|Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator|Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (>=2 months after last treatment): lymphocytes (LC) <4000 per microliter (μL), no lymphadenopathy (Ly)>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)>1500/µL, platelets (PL)>100,000/µL, hemoglobin (Hb)>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,<30% LC, no lymphoid nodule (LN). PR:>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N>1500/μL, PL>100,000/µL or 50% improvement over Baseline (BL), Hb>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population|||Participants|||Number
1370498|NCT01563055|Primary|Number of Participants Who Developed Toxicity Requiring Discontinuation From Study Treatment During Cycle 1|Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or <=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.|From start of treatment through Cycle 1 (Week 4)|All Subjects Population: all participants who received at least one dose of investigational product.|||Participants|||Number
1370499|NCT01563029|Secondary|Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period|The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.|Up to Week 12|ITT Population|||Participants|||Number
1370500|NCT01563029|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the percentage of symptom free 24-hr periods in the last 7 days of the run-in period. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment group.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1370501|NCT01563029|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1370502|NCT01563029|Secondary|Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1370503|NCT01563029|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||liters per minute (L/min)||Standard Error|Least Squares Mean
1370504|NCT01563029|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. The Baseline rescue-free value was defined as the percentage of rescue-free 24-hr periods from the last 7 days of the Run-in Period. Change from Baseline was calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1370505|NCT01563029|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, actual pre-screening ICS use, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements. Only those participants available at the specified time points were analyzed.|Baseline, Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1370506|NCT01563029|Primary|Change From Baseline in Daily Pre-dose Morning (AM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, actual pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population: participants randomized to treatment who received at least 1 dose of study medication. Only participants available at the specified time points were analyzed.|||Liters per minute (L/min)||Standard Deviation|Least Squares Mean
1370507|NCT01563003|Secondary|Clinical Global Impression - Severity Scale|Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
1370508|NCT01563003|Secondary|Anxiety Disorders Interview Schedule Clinical Severity Rating|Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
1370509|NCT01563003|Primary|Pediatric Anxiety Rating Scale|Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
1370510|NCT01562886|Secondary|Number of Subjects With HIV Viral Load Above 50 Copies Per mL|Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL)|Day 3,14, 28, 60, 80-100||||participants|||Number
1370511|NCT01562886|Primary|CSF:Plasma Ratio of Rilpivirine Levels|The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure|Day 60||||ratio expressed as a percentage||95% Confidence Interval|Geometric Mean
1370512|NCT01562873|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Disease was evaluated radiologically every 8 weeks on treatment through 12 cycles and in long-term follow-up every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).|The analysis dataset is comprised all enrolled patients.|||months||95% Confidence Interval|Median
1370513|NCT01562873|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|In long-term follow-up, patients were followed for survival every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).|The analysis dataset is comprised all enrolled patients.|||months||95% Confidence Interval|Median
1370514|NCT01562873|Secondary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).|The analysis dataset is comprised all enrolled patients.|||proportion of patients||90% Confidence Interval|Number
1370515|NCT01562873|Primary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).|The analysis dataset is comprised all enrolled patients.|||proportion of patients||90% Confidence Interval|Number
1370516|NCT01562756|Primary|Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.|Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.|Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits||||months|months||Number
1370517|NCT01562756|Primary|Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study|Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.|Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits||||participants|||Number
1370518|NCT01562743|Secondary|Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit|SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, Up to 53 weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1370519|NCT01562743|Primary|Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit|PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement.|Baseline, Up to 53 weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1370520|NCT01562743|Secondary|Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit|"ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24).~A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 52 weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1370521|NCT01562743|Secondary|Efficacy Rate in IRLS Sum Score|Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.|Baseline, Up to 53 weeks|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
1370522|NCT01562743|Secondary|Change of IRLS Sum Score From the Baseline to Each Visit|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, Up to 53 weeks|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1370523|NCT01562743|Primary|Augmentation|"Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity.~Augmentation is clinically significant when at least one of the following occurs:~Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;~Negative impact on the patient’s quality of life (sleep, mood, etc.) due to augmentation;~Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose);~Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity);~Any other aspect as judged by the evaluator (should be specified)."|Up to 53 weeks|SS|||participants|||Number
1370524|NCT01562743|Primary|The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters.~AEs of special interest (1-3) are defined as below:~sudden onset of sleep~obsessive-compulsive disorder or impulse-control disorder~hallucination, delusion"|Up to 54 weeks|Safety set (SS)|||participants|||Number
1370525|NCT01562678|Primary|Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization|Effect size (region of interest z-scores, derived from z-maps of the brain) shown below is the difference in parietal cortex activation to highly desirable (high fat or high calorie, e.g. cakes, pies, fries) versus less desirable (low fat or low calorie, e.g. vegetables, fruits) food cues for each treatment condition (liraglutide or placebo) at the end of the treatment period.|18 days of Liraglutide or placebo treatment|Participants with incomplete MRI scans were excluded from the analysis.|||z-scores of activation in cortex||Standard Error|Mean
1370539|NCT01562548|Primary|Mean Change From Baseline of Both AM and PM Spasm Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.|7 Days|Efficacy analysis was conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. Subjects were analyzed according to the treatment to which they were randomized.|||Score on a Scale||Standard Deviation|Mean
1370782|NCT01560143|Primary|Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours|The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L)|4 days (96 hours)||||hour*mg/L||Standard Deviation|Mean
1370526|NCT01562613|Secondary|Change in Framingham Stroke Risk Profile Scores of the Participating Patients|"The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke.~First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D’Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D’Agostino et al.~The score can range from 0-38 (according to the scales of D’ Agostino et al) with higher scores yielding increased 10-year probability of stroke."|Baseline up to 6 months|"Excluded from Framingham calculation were patients with either~a history of cerebrovascular accident~any of the parameters missing for the calculation of the Framingham~age <54 years or > 84 years for females & <54 or > 85 years for males"|||score on a scale||Full Range|Median
1370527|NCT01562613|Primary|The Absolute Change in Systolic Blood Pressure From Baseline|The absolute change in systolic Blood Pressure from baseline|Baseline up to 6 months||||mmHg||Standard Deviation|Mean
1370528|NCT01562613|Primary|The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions.|"The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions.~Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of <140 mmHg/90 mmHg [systolic BP (SBP)/diastolic BP (DBP)] for the general population of hypertensive patients OR of <130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions [stroke, myocardial infarction, coronary artery disease (CAD)]"|Baseline up to 6 months||||Percentage of participants||95% Confidence Interval|Number
1370529|NCT01562548|Secondary|Global Assessment of Headache Intensity (GAHI)|Categorized after treatment as: ‘decreased’, ‘increased’ or ‘stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||participants|||Number
1370530|NCT01562548|Secondary|Global Assessment of Headache Frequency (GAHF)|Categorized after treatment as: ‘decreased’, ‘increased’ or ‘stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||participants|||Number
1370531|NCT01562548|Secondary|Global Assessment of Sleep Disturbance (GASD)|Categorized after treatment as: ‘decreased’, ‘increased’ or 'stayed the same’.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||participants|||Number
1370532|NCT01562548|Secondary|Global Assessment of Treatment Helpfulness (GATH)|Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1370533|NCT01562548|Secondary|Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores|Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst.|Before treatment, 4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1370534|NCT01562548|Secondary|Muscle Relaxation Scores|The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1370535|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1370536|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1370537|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1370540|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370541|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370542|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370543|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370544|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370545|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370546|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370547|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370548|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370549|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370550|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370551|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370552|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370553|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370554|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370555|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370556|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370557|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370558|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370559|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370560|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370561|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1373758|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.|Preoperatively to 7 days after surgery|||||||
1370562|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370563|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370564|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370565|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370566|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370567|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370568|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370569|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370570|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370571|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370617|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370572|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370573|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370574|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370575|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370576|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370577|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370578|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370579|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370591|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370580|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370581|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370582|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370583|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370584|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370585|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370586|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370587|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370588|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Number of subjects||95% Confidence Interval|Number
1370589|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370590|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370593|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370594|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370595|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370596|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370597|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370598|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370599|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370600|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370601|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370602|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370603|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370604|NCT01562444|Primary|Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
1370605|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370606|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370607|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370608|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370609|NCT01562444|Primary|Evaluation of Geometric Mean Antibody Titers (GMTs)|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1370610|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370611|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370612|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370613|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370614|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370615|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370616|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370619|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2|Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
1370620|NCT01562379|Other Pre-specified|Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding|Maternal KAP|At 6, 12 and 18 months of age|||||||
1370621|NCT01562379|Secondary|Intestinal Function|Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth|At 24 months of age|||||||
1370622|NCT01562379|Secondary|Micronutrient Status|Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.|18 months of age|||||||
1370623|NCT01562379|Secondary|Cognitive and Motor Function|Using Bayley III|At 18 months of age|||||||
1370624|NCT01562379|Secondary|Developmental Milestones|Age-specific developmental milestones will be assessed|At 6, 12, and 18 months of age|||||||
1370625|NCT01562379|Secondary|Body Composition|Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age|At 6, 9 and 12 months of age|||||||
1370626|NCT01562379|Secondary|Morbidity|weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.|weekly from 6 to 18 months of age|||||||
1370627|NCT01562379|Primary|Stunting in Children at 18 mo|Prevalence of stunting at 18 months of age.|18 months of age|Children followed after 1 year of supplementation from 6 months at 18 months of age|||Participants|||Count of Participants
1370628|NCT01562327|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.|approximately 3 years|Safety population was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
1370629|NCT01562327|Secondary|Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
1370630|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6|The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
1370631|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6|The Patient Global Assessment of fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
1370632|NCT01562327|Secondary|Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant’s functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.|||percentage of participants|||Number
1370633|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
1370634|NCT01562327|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
1370651|NCT01562327|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least one of the conditions.|Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
1373759|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).|During dissection of the gallbladder|||||||
1370635|NCT01562327|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.|||percentage of participants|||Number
1370636|NCT01562327|Secondary|European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant’s disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Month 3, Month 6|Data was not collected, hence not reported.||||||
1370637|NCT01562327|Secondary|Simplified Disease Activity (SDAI) Response Classification|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.|Month 3, Month 6|Data was not collected, hence not reported.||||||
1370638|NCT01562327|Secondary|Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6|CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.|||participants|||Number
1370639|NCT01562327|Secondary|Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.|||participants|||Number
1370640|NCT01562327|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A decrease in score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Full Range|Median
1370641|NCT01562327|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A decrease in score indicated improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Full Range|Median
1370642|NCT01562327|Secondary|Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy|Percentage of participants on Tocilizumab as monotherapy or combination therapy (with DMARDs) were reported at start of treatment and at 6 months from the start of treatment.|Baseline, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
1370643|NCT01562327|Secondary|Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy||Approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
1370644|NCT01562327|Secondary|Reasons for Dose Modifications||approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.|||participants|||Number
1370645|NCT01562327|Secondary|Reason for Biologic Agent Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.|||participants|||Number
1370646|NCT01562327|Secondary|Percentage of Participants Who Previously Received Biologic Agents||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
1370653|NCT01562314|Post-Hoc|Change From Baseline To EOT In Levels Of Fecal Calprotectin- PP Analysis|Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||ug/g||Standard Deviation|Mean
1370654|NCT01562314|Post-Hoc|Change From Baseline To EOT In The Mayo Partial Score - PP Analysis Set|The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|PP Analysis Set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
1370655|NCT01562314|Post-Hoc|Change From Baseline To EOT In The Mayo Total Score - PP Analysis|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1370656|NCT01562314|Secondary|Change From Baseline To EOT In Levels Of Fecal Calprotectin|Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||microgram calprotectin/gram feces (ug/g)||Standard Deviation|Mean
1370657|NCT01562314|Secondary|Change From Baseline To EOT In The Mayo Partial Score|The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1370658|NCT01562314|Secondary|Change From Baseline To EOT In The Mayo Total Score|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1370659|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS - PP Analysis|Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
1370660|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS|Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1370661|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency NRS - PP Analysis|Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
1370662|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency Numerical Rating Scale (NRS)|Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1370663|NCT01562314|Secondary|Number Of Participants Who Reported An Improvement In The SGIC Questionnaire At EOT - PP Analysis|"Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment.” Improvement was considered as very much better, much better, or minimally better."|Visit 4 (Day 43) to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||Participants|||Count of Participants
1370664|NCT01562314|Secondary|Number Of Participants Who Reported An Improvement In The Subject Global Impression Of Change (SGIC) Questionnaire At EOT|"Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment.” Improvement was considered as very much better, much better, or minimally better."|Visit 4 (Day 43) to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||Participants|||Count of Participants
1370665|NCT01562314|Secondary|Change From Baseline To EOT In The IBDQ Total Score - PP Analysis|The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with IBD. Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
1370666|NCT01562314|Secondary|Change From Baseline To EOT In The Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score|The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with inflammatory bowel disease (IBD). Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for the outcome measure.|||units on a scale||Standard Error|Mean
1370667|NCT01562314|Secondary|Change From Baseline To EOT In The PGAS Score - PP Analysis|The PGAS required the physician to assess participants' disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
1370668|NCT01562314|Secondary|Change From Baseline To EOT In The PGAS Score|The PGAS required the physician to assess participants’ disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data to this outcome measure.|||units on a scale||Standard Deviation|Mean
1370669|NCT01562314|Secondary|Distribution On The PGAS At EOT - PP Analysis|The PGAS required the physician to assess participants’ disease severity on a 4-point scale (0 = normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease).|EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||Participants|||Count of Participants
1370670|NCT01562314|Secondary|Distribution On The PGAS At EOT|The PGAS required the physician to assess participants’ disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease).|EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||Participants|||Count of Participants
1370671|NCT01562314|Primary|Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT - PP Analysis|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||Participants|||Count of Participants
1370672|NCT01562314|Primary|Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); Physician’s Global Assessment of Illness Severity (PGAS): 0 = none, 1 = mild, 2 = moderate, and 3 = severe.|Baseline to End of Treatment (EOT) (10 weeks) or Early Termination (ET)|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized.|||Participants|||Count of Participants
1370673|NCT01562275|Secondary|Progression-Free Survival (PFS) Time for Participants With Measurable Disease According to RECIST v1.1|PFS is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.||||||
1370674|NCT01562275|Secondary|Duration of Objective Response for Participants With Measurable Disease According to RECIST v1.1|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.||||||
1370675|NCT01562275|Secondary|Number of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|RECIST v1.1 (for measurable disease), CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|Safety analysis population.|||participants|||Number
1370676|NCT01562275|Secondary|Last Measurable Concentration (Clast) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."|||ng/mL||Standard Deviation|Mean
1370677|NCT01562275|Secondary|Time Taken to Reach Cmax (Tmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."|||hours||Full Range|Median
1370913|NCT01557920|Secondary|Airway Diameter|Using acoustic pharyngometry, we intend to measure the cross-sectional area of the airway at several points during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|No data were obtained.||||||
1370679|NCT01562275|Secondary|Area Under Concentration-Time Curve From Time Zero to Last Measurable Concentration After Dose [AUC0–Last] of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population: Included all participants who received study treatment and had at least 1 cobimetinib and ipatasertib plasma concentration available. n represents the number of participants who were evaluable for that particular assessment."|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1370680|NCT01562275|Primary|Number of Participants With At Least One AE Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version (V) 4.0|AE was defined in Outcome Measure 3. AEs were graded as per NCI CTCAE V 4.0 as follows: G 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL) (instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money and others); G 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL (refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden); G 4: Life-threatening consequences, urgent intervention indicated; G 5: Death related to AE. If a participant had multiple events of different grades, the highest grade that occurred in that participant was counted.|From Baseline up to 30 days after the last dose of study treatment or until initiation of another anticancer treatment whichever occurred first (Up to 33 months)|Safety analysis population.|||participants|||Number
1370681|NCT01562275|Primary|Maximum Tolerated Doses (MTDs) in Combination of Cobimetinib and Ipatasertib During Dose-Escalation Stage 1|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. On the basis of AEs that did not meet protocol-defined DLT criteria (defined in Outcome measure 1) but indicated intolerability of a given dose combination, the combination MTDs were determined (as per investigator) during Stage 1 of the study.|Cycle 1 (28 Days)|Safety analysis population participants from dose escalation cohorts.|||milligrams|||Number
1370682|NCT01562275|Primary|Number of DLTs Categorized as Per the Nature|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) G ≥3 febrile neutropenia, b) G ≥4 neutropenia (ANC <500/μL) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or ALP lasting >3 days, f) Hepatic transaminases >3 × ULN and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days. Hematologic, Hepatic and non-hematologic and non-hepatic DLT categories were to be reported.|Cycle 1 (28 Days)|Data for this outcome measure was not analyzed as no participant experienced DLT.||||||
1370683|NCT01562275|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) Grade (G) ≥3 febrile neutropenia, b) G ≥4 neutropenia (absolute neutrophil count [ANC] <500/ microliter [μL]) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or alkaline phosphatase (ALP) lasting >3 days, f) Hepatic transaminases >3 × Upper Limit of Normal (ULN) and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days.|Cycle 1 (28 Days)|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome was analyzed in safety analysis population participants in dose escalation cohorts.|||participants|||Number
1370684|NCT01562132|Secondary|Cryptococcal Meningitis-free Survival at 24 Weeks|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.~Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks|||||||
1370685|NCT01562132|Secondary|Number of Individuals With Treatment Related Serious Adverse Events||24 weeks|||||||
1370686|NCT01562132|Secondary|Number of Individuals With Treatment Related Adverse Events||24 weeks|||||||
1370687|NCT01562132|Secondary|Proportion of Individuals Requiring Dose Reduction||24 weeks|||||||
1370688|NCT01562132|Secondary|Proportion of Individuals Requiring Treatment Discontinuation||4 weeks|||||||
1370689|NCT01562132|Secondary|Achieve Targeted Recruitment, Retention and Adherence Rates||24 weeks|||||||
1370690|NCT01562132|Secondary|Number of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus|"Individuals who develop clinical meningitis without evidence of fungal, bacterial, or parasitic (e.g. malaria) organisms in the cerebrospinal fluid. Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks|||||||
1370691|NCT01562132|Secondary|Number of Individuals Who Develop Cryptococcal Meningitis|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.~Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks|||||||
1370692|NCT01562132|Secondary|Survival at 24 Weeks||24 weeks|||||||
1370693|NCT01562132|Secondary|Survival at 2 Weeks||2 weeks|||||||
1370695|NCT01561976|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, medically significant or possible drug-induced liver injury.|Up to approximately 24 days (during treatment and washout) after initiation of study|PK Population.|||Participants|||Count of Participants
1370696|NCT01561976|Secondary|Terminal Phase Half Life (t1/2)|PK blood samples for estimation of t1/2 were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour||Full Range|Median
1370697|NCT01561976|Secondary|Elimination Constant (Kel)|PK blood samples for estimation of Kel were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Fraction/hour||Full Range|Median
1370698|NCT01561976|Secondary|PK Lag Time (Tlag)|PK blood samples for estimation of Tlag were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour||Full Range|Median
1370699|NCT01561976|Secondary|Time of Occurrence of Cmax (Tmax)|PK blood samples for estimation of Tmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour||Full Range|Median
1370700|NCT01561976|Secondary|AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC (0-t)]|PK blood samples for estimation of AUC (0-t) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||µ.hr/mL||Geometric Coefficient of Variation|Geometric Mean
1370701|NCT01561976|Primary|Area Under Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC (0-infinity)]|PK blood samples for estimation of AUC (0-infinity) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Micrograms hour per milliliter (µ.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1370702|NCT01561976|Primary|Maximum Observed Concentration (Cmax)|Pharmacokinetic (PK) blood samples for estimation of Cmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population included participants who received study medication. Only those participants available at the indicated time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1370703|NCT01561898|Primary|Incidence of Adverse Events|The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.|48 weeks|Intent-to-treat (ITT) population|||percentage of patients|||Number
1370704|NCT01561898|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|Baseline, Week 48|Intent-to-treat (ITT) population|||scores on a scale||Standard Deviation|Mean
1370705|NCT01561898|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS)|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 48|Intent-to-treat (ITT) population|||scores on a scale||Standard Deviation|Mean
1370706|NCT01561755|Secondary|Impression of Change Score - Clinician|The clinician measure of Global Impression of Change reflects the clinician's view about the efficacy of treatment as measured by 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening|at 2 months||||units on a scale||Full Range|Mean
1370709|NCT01561755|Secondary|Bowel Function|0 = No bowel problems, 1 = Asymptomatic on current drug tx or constipation not requiring any tx, 2 = Constipation requiring laxative or suppositories or fecal urgency, 3 = Constipation requiring the use of an enema, 4 = Constipation requiring manual evacuation of stools or occasional fecal incontinence (once or more during the last month but not every week, 5 = Weekly fecal incontinence|2 months||||units on a scale||Full Range|Mean
1370710|NCT01561755|Secondary|Urinary Function|0 = Normal bladder function, 1 = Asymptomatic on current treatment, 2 = Urinary frequency, hesitancy, urgency, with no incontinence, 3 = Occasional urinary incontinence (once or more during the last month but not every week) or intermittent catheterization, 4 = Frequent urinary incontinence, or occasional incontinence despite regular catheterization, 5 = Daily urinary incontinence or permanent catheter|2 months||||units on a scale||Full Range|Mean
1370711|NCT01561755|Secondary|Walking Test|2 minute walking test|at 2 months|One participant in placebo group in wheelchair and unable to complete the walking test|||meters||Standard Deviation|Mean
1370712|NCT01561755|Primary|Strength Scores|Strength score as measured by pounds of force sustained in lower extremity strength.|at 2 months||||pounds of force||Standard Deviation|Mean
1370713|NCT01561716|Primary|Energy Expenditure|Energy expenditure is measured using continuous, computerized open-circuit indirect calorimetry (oxygen consumption and carbon dioxide production) and converted to metabolic equivalents (METs).|30 min continuous monitoring at rest and during each physical activity||||METs||Standard Deviation|Mean
1370714|NCT01561703|Primary|Healthcare Utilization|Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.|6 wks post-operative appointment||||participants|||Number
1370715|NCT01561560|Primary|End-of-day Comfort|"End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, Please rate the study lenses you have been wearing the in the following area: End-of-day comfort and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent)."|Week 2|This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
1370716|NCT01561469|Secondary|Number of Antibiotic Free Days||Up to 28 days after diagnosis of VAP|Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.||||||
1370717|NCT01561469|Secondary|Duration of Antimicrobial Treatment||Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Standard Deviation|Mean
1370718|NCT01561469|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Inter-Quartile Range|Median
1370719|NCT01561469|Secondary|Duration of Intensive Care Unit (ICU) Stay|Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Inter-Quartile Range|Median
1370720|NCT01561469|Secondary|Duration of Hospital Stay|Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Inter-Quartile Range|Median
1370721|NCT01561469|Secondary|Number of Participants With Microbiological Outcome|Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).|28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||participants|||Number
1370722|NCT01561469|Primary|Percentage of Participants With Clinical Success|Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.|14 days after diagnosis with VAP or hospital discharge, whichever occurred first|Analysis population included all participants who met the eligibility criteria for this study.|||percentage of participants|||Number
1370723|NCT01561430|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations|Percent change in lumbar CSF tau and ptau-181 concentrations from baseline at 12 weeks post-dose and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.|Baseline, 12 weeks, 26 weeks|"All randomized participants at 12 weeks with evaluable post-baseline CSF Tau or Ptau data.~Zero participants analyzed for 26 week CSF Tau or Ptau as data was not collected for analysis."|||percent change in tau and ptau-181||Standard Error|Least Squares Mean
1370724|NCT01561430|Secondary|Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)|The MMSE (Folstein et al. 1975) is one of the most widely used screening instruments for cognitive impairment. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and provides a total score ranging from 0 to 30, with lower scores indicative of greater cognitive impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.|Baseline, 26 weeks|All randomized participants with evaluable MMSE data.|||units on a scale||Standard Error|Least Squares Mean
1370725|NCT01561430|Secondary|Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)|The CDR-SB is a composite measure of 6 domains of cognitive and functional performance: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores ranged from 0 to 18, with higher scores indicating greater impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.|Baseline, 26 weeks|All randomized participants with evaluable CDR-SB data.|||units on a scale||Standard Error|Least Squares Mean
1370726|NCT01561430|Secondary|Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|ADAS-Cog11 is an 11-item instrument measuring impairment in memory (Items 1-4, 7, 11), praxis (Items 4 and 5), orientation (Item 6), and language (Items 8-10). Item 1 ranged 0 (all items recalled correctly)-10 (none recalled correctly); Items 2-5 and 8-11 ranged 0 (all items named, performed, drawn, spoken, remember correctly/clearly)-5 (none correct/not clearly spoken); Item 6 ranged 0 (no incorrect responses)-8 (all incorrect); and Item 7 ranged 0 (all words remembered correctly)-12 (no words remembered correctly) for a total ADAS-Cog11 score of 0-70 with higher scores indicating greater disease severity. A score of 0-10 for delayed free recall and a conversion code of 0-5 for digit cancellation and maze completion was added to the total ADAS-Cog11 score for a total ADAS‑Cog14 score ranging 0-90 with higher scores indicating greater impairment. LS means were calculated using Mixed Model Repeated Measures (MMRM) with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.|Baseline, 26 weeks|All randomized participants with evaluable ADAS-Cog data.|||units on a scale||Standard Error|Least Squares Mean
1370727|NCT01561430|Secondary|Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)|The NTB is a composite cognitive measure in clinical Alzheimer’s disease studies and is a collection of several written and oral tests that examines verbal and nonverbal brain functions. NTB Z-score typically ranges from -3 to 3, with lower scores suggesting greater cognitive impairment. LS means were calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.|Baseline, 26 weeks|All randomized participants with evaluable NTB data.|||units on a scale||Standard Error|Least Squares Mean
1370728|NCT01561430|Secondary|Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations|Percent change in plasma concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL).|Baseline, 12 weeks, 26 weeks|All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.|||percent change in Aβ1-40 and Aβ1-42||Standard Deviation|Mean
1370729|NCT01561430|Primary|Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations|Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 26 weeks post-dose was to be calculated. The units for CSF were picograms per milliliter (pg/mL). LS means of percent change in concentration from baseline was calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.|Baseline, 26 weeks|Zero participants analyzed. CSF Aβ1-40 and Aβ1-42 concentrations data was not collected for analysis at 26 weeks.||||||
1370730|NCT01561430|Primary|Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations|Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.|Baseline, 12 weeks|All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.|||percent change in Aβ1-40 and Aβ1-42||Standard Error|Least Squares Mean
1370731|NCT01561313|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious Adverse Events were collected from the time the participant signed the informed consent.||||participants|||Number
1370732|NCT01561313|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1370733|NCT01561313|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1370734|NCT01561313|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1370735|NCT01561313|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1370736|NCT01561313|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection, with 0 representing no pain and 10 representing the worst possible pain.|15 minutes post injection||||cm||Standard Deviation|Mean
1370737|NCT01561313|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection||||cm||Standard Deviation|Mean
1370738|NCT01561300|Secondary|Chronic Effect of Tea vs Control|"Change in flow mediated dilation (FMD) due to tea consumption when compared to control.~FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (baseline)~5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease~4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|From baseline at day 1 to baseline on day 8|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.|||Percentage change in flow mediated dilat||95% Confidence Interval|Least Squares Mean
1370766|NCT01560403|Primary|Summary of Treatment-emergent Adverse Events|As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.|12 months|Safety Population|||participants|||Number
1370767|NCT01560260|Secondary|Time to Progression|Evaluated using cumulative incidence.|Up to 2 years|||||||
1370768|NCT01560260|Secondary|Response Duration|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks|||||||
1370739|NCT01561300|Secondary|Acute Effect of Tea vs Control|"Change in flow mediated dilation due to tea consumption when compared to control.~FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (baseline)~5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease~4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|From baseline on day 1 to 2 hours post consumption on day 1|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.|||percent change in flow mediated dilation||95% Confidence Interval|Least Squares Mean
1370740|NCT01561300|Primary|'Acute-upon-chronic Effect' of Tea vs Control|"Change in flow mediated dilation (FMD) due to tea consumption when compared to control.~FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (baseline)~5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease~4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|Baseline day 1 to 2 hours post consumption on day 8.|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.|||percentage of change in diameter||95% Confidence Interval|Least Squares Mean
1370741|NCT01561079|Primary|Fetal Movement - Fetal Heart Rate Coupling|The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system.|24, 28, 32, 36 weeks of gestation||||percentage of time FM assoc w FHR change||Standard Deviation|Mean
1370742|NCT01561079|Primary|Fetal Movement|Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels|24, 28, 32, 36 weeks of gestation||||seconds||Standard Deviation|Mean
1370743|NCT01561079|Primary|Accelerations of Fetal Heart Rate|Number of accelerations of fetal heart rate exhibited during the 60 minute recordings|24, 28, 32 36 weeks of gestation||||accelerations||95% Confidence Interval|Mean
1370744|NCT01561079|Primary|Fetal Heart Rate Variability|Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels|24, 28, 32 and 36 weeks of gestation|Per protocol|||msec||Standard Deviation|Mean
1370745|NCT01561079|Primary|Fetal Heart Rate|Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels|24, 28, 32 and 36 weeks of gestation|Participants active in the protocol at 24, 28, 32 and 36 weeks, respectively|||beats per minute||Standard Deviation|Mean
1370746|NCT01560988|Secondary|Genotype-specific Differences in Change in Lung Function While Receiving Borage and Echium Oils Versus Corn Oil.|FEV1 was measured in all subjects at the beginning and end of both study arms. Subjects were genotyped at LTC4S locus and those bearing at least one A to C polymorphism were compared with those bearing two A alleles.|0, 42, 84, and 126 days|We analyzed all samples available including subjects who did not complete the entire protocol. Therefore the number of subjects analyzed differs from the total number of subjects per arm.|||Liters||Standard Deviation|Mean
1370747|NCT01560988|Secondary|Change in Activity of LTC4 Synthase|Differences in LTC4S activity while receiving borage/echium oils versus corn oil stratified by LTC4S genotype. We analyzed the genotype for 32 subjects for the borage arm and 30 subjects for the placebo arm.|Days 0, 42, 84, and 126|Since this is a crossover study, 30 of 32 who completed the borage arm also completed the corn oil arm. The data presented reflect the effects of borage/echium versus corn oil for individuals with two wild type alleles (AA) versus those with one variant allele (CC or AC).|||ng/million cells||Standard Deviation|Mean
1370748|NCT01560988|Secondary|Measure of EPA in Cell Pellets|Secondary outcome measures include changes in concentrations of omega 3 fatty acids in cell pellets, indicating incorporation of botanical oil metabolites in cell membrane lipids.. This was calculated by the difference between the amount present at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
1370749|NCT01560988|Secondary|Asthma Control|Changes in asthma control will be assessed via the Asthma Control Questionnaire (ACQ) at each visit. The ACQ is a 6-point questionnaire that reflects the degree of asthma activity. Each point is assigned a scale of 0-5, with 5 being the worst. Thus, the range is from 0 (no asthma symptoms) to 30 (severe asthma symptoms). For each arm, we generate two values (week 2 vs. week 8 and week 14 vs.week 20). These values are then averaged for each arm to obtain the final single value. A negative number implies improved symptoms.|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||Change in ACQ points||Standard Deviation|Mean
1370750|NCT01560988|Secondary|Number of Subjects Bearing a Polymorphic Variant of LTC4 Synthase|All individuals will be genotyped at the LTC4S locus.|two weeks|We analyzed all samples available including those who did not complete both arms of the protocol. Therefore the number of subjects in the two arms are not identical.|||participants|||Number
1370769|NCT01560260|Secondary|PFS|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Time from date of enrollment to time of progression or death due to any cause, assessed up to 37 weeks|||||||
1370770|NCT01560260|Secondary|OS|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks|||||||
1370751|NCT01560988|Secondary|Plasma Level of Gamma Linolenic Acid (GLA)|Changes in plasma level of gamma linolenic acid (GLA), a major constituent of Borage oil, as a measure of compliance. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Measurements obtained at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
1370752|NCT01560988|Secondary|Lung Function|Changes in lung function (forced expiratory volume in 1 second) will be assessed via spirometry at each visit. This was calculated by the difference between the FEV1 at weeks 2 and 8 versus weeks 14 and 20. The differences were compared as a delta-delta. A negative number for this parameter means that the FEV1 was lower at the end of the arm than at the beginning, while a positive number means that the FEV1 was higher at the end.|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||Percent change||Standard Deviation|Mean
1370753|NCT01560988|Secondary|Measure of DHA in Cell Pellets|Secondary outcome measures include changes in concentrations of omega 3 fatty acids in cell pellets, indicating incorporation of botanical oil metabolites in cell membrane lipids.. This was calculated by the difference between the amount present at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
1370754|NCT01560988|Primary|Change in LTB4 Production|Primary outcome measures will be changes in the generation of LTB4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta). A negative number implies that the level of LTB4 produced by granulocytes at the end of the arm was less than the amount produced at the start of the arm, while a positive number means that more was generated at the end than at the beginning.|At 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
1370755|NCT01560988|Primary|Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation|Primary outcome measures will be changes in the generation of LTC4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm.|||ng||Standard Deviation|Mean
1370756|NCT01560975|Secondary|Effect After CPAP Removal on the IOP Pattern|IOP pattern immediately after CPAP removal upon waking in patients with or without POAG|30 min||||mvEq||Standard Deviation|Mean
1370757|NCT01560975|Secondary|Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters|"Heart rate and ocular pulsation rate during sleep:~using CPAP in patients with or without POAG~not using CPAP in patients with or without POAG"|24-hours||||Correlation||Standard Deviation|Mean
1370758|NCT01560975|Primary|Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG|"24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS.~using CPAP in patients with or without POAG~not using CPAP in patients with or without POAG"|24 hours||||mVEq/h||Standard Deviation|Mean
1370759|NCT01560819|Primary|Clinical Response|Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment|4 weeks following GMT Treatment|One participant showed intolerance to the treatment (immediate leaking of enema) and was not included in post-treatment disease activity evaluation.|||Participants|||Number
1370760|NCT01560507|Secondary|Quit Success Genotype Score|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.”|After 6 month Follow-Up|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1370761|NCT01560507|Primary|Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|End of study drug treatment period (11-12 weeks)|||||||
1370762|NCT01560429|Primary|Anesthetic Consumption (mg)|amount of anesthetic consumed was calculated for each group over time.|4,8,12, 24 and 48 hours postoperatively||||mg||Standard Error|Mean
1370763|NCT01560429|Secondary|Worst Pain While Coughing|Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy|48 hours postoperatively|||||||
1370764|NCT01560429|Secondary|Worst Pain Scores|worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery|48 hours postoperatively|||||||
1370765|NCT01560429|Primary|Local Anesthetic Consumption|Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.|48 hours postoperatively||||ug||Standard Error|Mean
1370771|NCT01560260|Secondary|Failure-free Survival|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks|||||||
1370783|NCT01559935|Secondary|Stem Cells Collection|At the end of the Car Phase, all participants underwent stem cell collection.|At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.|58 participants reached the end of the Car Phase. From those 58 participants, 52 were collected, 5 participants declined stem cell collection and 1 participant's results were not evaluable.|||Number of stem cells collected per Kg||Standard Deviation|Mean
1370784|NCT01559935|Secondary|Progression Free Survival|Progression was defined using the IMWG criteria.|From start of study drug until first incidence of progression, up to 1222 days.|21 participants had an incidence of progression.|||months||Full Range|Median
1370785|NCT01559935|Secondary|MRD Negativity Following CarBiRD Regimen|"Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on.~MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy.~MRD positivity is defined as the presence of residual plasma cells (<5%) on bone marrow biopsy.~The IMWG criteria were used to determine CR and sCR."|From start of study up to Revlimid Maintenance Cycle 4.|28 participants achieved CR or sCR.|||Participants|||Count of Participants
1370786|NCT01559935|Secondary|Event Free Survival|an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.|From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.|44 participants analyzed out of the 72 participants initially enrolled in the study. 28 participants are active and therefore have not experienced any events leading to removal from study.|||Days||Full Range|Median
1370787|NCT01559935|Primary|Response to Car-BiRD Treatment.|"The best response for all patients who had at least one dose of drug was measured.~Response categories:~Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).~The response is evaluated based on the IMWG criteria."|From baseline to best response, up to 116 weeks.||||Participants|||Count of Participants
1370788|NCT01559922|Primary|ASRS Responder Rate at 6 Months|"Subject considered to be a responder if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment)."|6 months post-treatment|Full Analysis Population included only subjects that passed screening|||percentage of participants||95% Confidence Interval|Number
1370789|NCT01559857|Secondary|Change in HDRS-21: From Baseline to 12 Weeks|The HDRS-21 was administered at baseline and at the end of 12 weeks, and the mean difference between the two time points was calculated. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity.|12 weeks||||units on a scale||Standard Deviation|Mean
1370790|NCT01559857|Secondary|Fasting Insulin Measurements at Baseline|The fasting plasma insulin measurements taken at baseline are shown in the data table below.|Baseline||||uIU/mL||Standard Deviation|Mean
1370791|NCT01559857|Primary|Hamilton Depression Rating Scale at Baseline|The HDRS-21 was used to screen for unremitted depression. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity. Unremitted depression is characterized by a score of ≥7. The HDRS-21 scores at baseline are shown in the data table below.|Baseline||||units on a scale||Standard Deviation|Mean
1370792|NCT01559844|Primary|Number of Participants Who Died|"Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days.~Only those participants who underwent liver transplantation were analyzed for death post-transplantation."|Up to 48 weeks following transplant|Safety Analysis Set|||participants|||Number
1370793|NCT01559844|Secondary|Proportion of Participants With Virologic Failure Prior to Transplant|"Virologic failure (VF) in the pretransplant phase was defined by:~Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA < 25 IU/ml, while on treatment)~Rebound (breakthrough or > 1 log10 IU/ml increase in HCV RNA from nadir while on treatment)~Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment)~Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA < 25 IU/ml at last observed HCV RNA on treatment)"|Up to 48 weeks prior to transplant|On-treatment VF: Full Analysis Set. Posttreatment/Pretransplant VF - 24 Weeks or 48 Weeks: Participants who completed 24 or 48 weeks of treatment and had an observed or imputed Week 4 posttreatment follow-up HCV RNA value relapsed during posttreatment follow-up were analyzed.|||percentage of participants|||Number
1370794|NCT01559844|Secondary|HCV RNA and Change From Baseline in HCV RNA Through Week 8||Up to 8 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1370795|NCT01559844|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48||Up to 48 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1370796|NCT01559844|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant.|Up to 48 weeks following transplant|Participants in the Full Analysis Set who underwent liver transplantation and who had ≥ 12 weeks treatment and HCV RNA < LLOQ at last measurement prior to transplant were analyzed.|||percentage of participants|||Number
1370797|NCT01559844|Primary|Percentage of Participants With Graft Loss Following Transplant||Up to 48 weeks following transplant|Participants in the Safety Analysis Set who underwent liver transplantation were analyzed.|||percentage of participants|||Number
1370798|NCT01559844|Primary|Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant||Up to 48 weeks prior to transplant|Safety Analysis Set|||percentage of participants|||Number
1370799|NCT01559844|Primary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant.|Posttransplant Week 12|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study drug) who underwent liver transplantation, and who had HCV RNA < LLOQ at last measurement prior to transplant were analyzed.|||percentage of participants|||Number
1370800|NCT01559675|Primary|Orthostatic Hypotension||Postoperative Day 1||||participants|||Number
1370801|NCT01559649|Secondary|Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items|Determine if stroke-ward staff nurses can make reliable inter-rater judgments of swallowing (e.g. cough after swallow, wet voice after swallow) and nonswallowing features (e.g. decreased volitional cough, dysarthria) historically used by SLPs to make judgments of aspiration.|3 years||||kappa||95% Confidence Interval|Number
1370802|NCT01559649|Secondary|Average Accuracy Rate for Nurse Administration for All Screening Procedures|Determine if current stroke-ward staff nurses can accurately administer screening items.|3 years||||percentage of accuracy||Full Range|Mean
1370803|NCT01559649|Primary|Negative Predictive Value of Screening Items|Identify the combination of screenings items that provide the highest level of negative predictive value in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure|||percentage of agreement||95% Confidence Interval|Number
1370804|NCT01559649|Primary|Specificity of Screening Items|Identify the combination of screenings items that provide the highest level of specificity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure|||percentage of agreement||95% Confidence Interval|Number
1370805|NCT01559649|Primary|Sensitivity of Screening Items|Identify the combination of screenings items that provide the highest level of sensitivity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure|||percentage of agreement||95% Confidence Interval|Number
1370806|NCT01559506|Primary|CFU Density|Colony-forming unit density at incision site (CFU/m3)|Surgical case CFU density will be determined at up to 1 month from completion of surgical cases||||CFU/m^3||95% Confidence Interval|Mean
1370807|NCT01559454|Secondary|Treatment Retention|Number of participants that completed the study protocol|6 months||||participants|||Number
1370808|NCT01559454|Secondary|Depression|"Depression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being none and 63 being severe."|at 6 months||||units on a BDI scale||Standard Deviation|Mean
1370809|NCT01559454|Secondary|Functioning|"Functioning will be assessed using the Visual Analogue Scale (VAS) with 0 being no limits and 100 being bedridden."|at 6 months||||units on a VAS scale||Standard Deviation|Mean
1370810|NCT01559454|Secondary|Cravings|Cravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings|at 6 months||||units on a VAS scale||Standard Deviation|Mean
1370811|NCT01559454|Secondary|Illicit Drug Use|Illicit opioid use will be measured by self-report and confirmed with urine toxicology.|6 months|19 participants were enrolled in the study, and 10 were available at the 6-month follow-up|||participants|||Number
1370812|NCT01559454|Primary|Analgesia|Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain.|6 months|19 participants were enrolled in the study, and 10 were available for the 6-month follow-up.|||units on a VAS scale||Standard Deviation|Mean
1370813|NCT01559311|Primary|LVESV|Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.|||ml||Standard Deviation|Mean
1370814|NCT01559311|Primary|LVEF|Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.|||% LVEF||Standard Deviation|Mean
1370815|NCT01559116|Secondary|Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment.~Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)|||Litres (L)||Standard Error|Mean
1370816|NCT01559116|Secondary|Trough FVC Response [L] After 6 Weeks Treatment.|"Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period.~The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
1370817|NCT01559116|Secondary|FVC AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
1370818|NCT01559116|Secondary|FVC AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)|||Litres (L)||Standard Error|Mean
1373760|NCT01523886|Secondary|Surgical Space Conditions|The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.|From surgical incision to last suture has been placed, an expected average of 30 minutes.|||||||
1370819|NCT01559116|Secondary|FVC AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres(L)||Standard Error|Mean
1370820|NCT01559116|Secondary|Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response.~The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
1370821|NCT01559116|Secondary|Trough FEV1 Response [L] After 6 Weeks Treatment.|"Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period.~The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)|||Litres||Standard Error|Mean
1370822|NCT01559116|Secondary|FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
1370823|NCT01559116|Secondary|FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
1370824|NCT01559116|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS): This patient set included patients in the Treated Set (TS) who had any period baseline and any evaluable post-dose data for the primary efficacy endpoint at any Week 6 visits.|||Litres (L)||Standard Error|Mean
1370825|NCT01559064|Primary|Subject Experience Measured by Patient Satisfaction Questionnaire|Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy|3 weeks||||Units on a scale||Standard Deviation|Mean
1370826|NCT01559012|Secondary|Diastolic Blood Pressure|Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle|10 days||||mmHg||95% Confidence Interval|Mean
1370827|NCT01559012|Secondary|Systolic Blood Pressure|Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)|10 days||||mmHg||95% Confidence Interval|Mean
1370828|NCT01559012|Secondary|Newborn Outcome Measure: APGAR Score.|"The APGAR score is the most common indicator of neonatal status immediately after delivery.~The test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's:~Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth."|at 1 minute and at 5 minutes after delivery|APGAR score of newborns at 1 minute and at 5 minutes|||units on a scale||Full Range|Mean
1370829|NCT01559012|Secondary|Pregnancy Outcome Measures: Birth Weight.|Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.|at delivery|no determination of sample size Recording for safety issue|||grams||Full Range|Mean
1370830|NCT01559012|Secondary|Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.|the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective|at 10 days since start of treatment|no determination of sample size|||participants|||Number
1370831|NCT01559012|Secondary|Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only|if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days||||Proportion of person-days||95% Confidence Interval|Mean
1370941|NCT01557504|Primary|Number of Participants Who Experienced an Abnormal Vital Sign Value|Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.|||Participants|||Number
1370832|NCT01559012|Secondary|Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.|"The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis.~All patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms."|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days||||daily doses of antiemetics||95% Confidence Interval|Mean
1370833|NCT01559012|Secondary|Morning Urine Ketonuria|Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days||||Proportion of person-days||95% Confidence Interval|Mean
1370834|NCT01559012|Primary|VAS Score for Assessment of Severity in Hyperemesis Gravidarum|VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.||||units on a scale||95% Confidence Interval|Mean
1370835|NCT01559012|Primary|PUQE Score for Assessment of Severity in Hyperemesis Gravidarum|"PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy.~It is composed of three items; every item has a score from 1 (best) to 5 (worst).~The sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily."|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.|A sample size calculation for crossover studies using a model available on line (MGH Mallinckrodt General Clinical Research Center - Harvard Medical School) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P < 0.01 and a beta > 0.90.|||units on a scale||95% Confidence Interval|Mean
1370836|NCT01558791|Primary|Illness Perception - Duration of Symptoms|Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted questionnaire|||units on a scale||Standard Deviation|Mean
1370837|NCT01558791|Primary|Illness Perception - Current Symptoms|Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans who accepted questionnaire|||units on a scale||Standard Deviation|Mean
1370838|NCT01558791|Secondary|Feasibility Questionnaire|A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.|One month- Providers complete a questionnaire within 1 month after data collection ends for the site.|||||||
1370839|NCT01558791|Primary|mTBI Questionnaire|The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted the questionnaire.|||correct answers out of 10||Standard Deviation|Mean
1370840|NCT01558739|Secondary|Percentage of Participants With Transfusion Dependency Status|Transfusion dependency status from baseline through the end of study was assessed. New onset of transfusion dependency was defined as the use of 2 or more units of red blood cell products during the 8 weeks prior to a study visit. New onset of transfusion independency was defined as the use of 0 or 1 unit of red blood cell products during the 8 weeks prior to a study visit.|baseline (BL), end of treatment (up to 28 days post last treatment) (EOT)|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
1370841|NCT01558739|Secondary|Number of General Practitioner (GP), Specialists' and Urgent Care Visits|MRU was assessed according to the number of GP, specialists', and urgent care visits.|baseline to week 12, week 12 to, week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||number of visits||Full Range|Median
1370842|NCT01558739|Secondary|Number of Accident & Emergency Visits From Baseline|MRU was assessed according to the number of accidents and emergency room visits.|baseline to week 12, week 12 to week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Number of visits||Full Range|Median
1370843|NCT01558739|Secondary|Duration of Hospitalizations|MRU was assessed according to the mean duration of hospitalization visits.|week 48|Participants from the full analysis set, who were hospitalized between baseline and week 48, were included in the analysis.|||days||Standard Deviation|Mean
1370844|NCT01558739|Secondary|Number of Hospitalizations|Medical resource utilization (MRU) was assessed according to the number of hospitalizations.|week 12, week 24, week 26, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at the post-baseline week time point, were included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||number of hospitalizations||Standard Deviation|Mean
1371077|NCT01556425|Secondary|Percent of Weekly Urine Samples Negative for Cocaine|Was the participant’s urine sample negative for cocaine at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for cocaine.|24 weeks||||percentage of cocaine negative samples||Full Range|Mean
1370845|NCT01558739|Secondary|Change From Baseline in EQ5D Preference Index (5 Level EuroQol Questionnaire Determining Quality of Life) From Baseline|The EQ-5D is a standardized instrument used for measuring health outcomes in a wide range of health conditions and treatment. It consists of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ-VAS records the participant's self-rated health on a vertical, VAS where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state'. The EQ-5D health state was converted to a single summary index by applying a formula that attaches a weight to each of the levels in each dimension. The final EQ5D preference index scores range from 0 to 1 with higher scores indicating better health.|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||unit on a scale||Standard Deviation|Mean
1370846|NCT01558739|Secondary|Change From Baseline in Myelofibrosis Symptoms Assessment Form (MF-SAF)|The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions are scored on a scale of 0–10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1–6, which together comprise a Total Symptom Score (TSS), investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asks patients to report levels of inactivity. The TSS reflects the sum of the scores of these symptoms excluding inactivity, with the maximum possible score being 60 (most severe symptom experienced).|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
1370847|NCT01558739|Secondary|Percentage of Participants With Best Overall Response|Response to treatment and disease progression was assessed by physical examination, specifically assessing changes in spleen size by palpation. Disease response and progression was evaluated using the International Working Group for myelofibrosis Research and Treatment Response Criteria.|week 48|Full Analysis Set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
1370848|NCT01558739|Primary|Percentage of Participants With Treatment Success|Treatment success was defined as a 50% or greater reduction in palpable spleen length versus baseline at 48 weeks and/or a 50% or greater improvement in total symptom score (derived from the MF symptom assessment form (MFSAF) questionnaire) versus baseline at the week 48 time point. The MFSAF assesses the following symptoms (all scored from absent (0) to worst imaginable (10)): general fatigue, abdominal pain (and discomfort), inactivity (ability to move and walk around), cough, night sweats, itching (pruritus), bone pain (diffuse not joint pain or arthritis), fever, change in appetite/unintentional weight loss (or gain) in past 6 months, overall quality of life (QoL).|48 Weeks|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
1370849|NCT01558700|Secondary|Change in Pain Magnitude|The Western Ontario and McMaster Osteoarthritis Index (WOMAC) score change was assess by subtracting WOMAC score after treatment (week 16) to the baseline WOMAC score. WOMAC score has a range from 0 up to 96, higher score meaning worse condition. The outcome is the decrease in WOMAC scores, meaning that the higher is the decrease, the most improvement in the condition.|16 weeks compared to baseline||||Scores on a scale||Standard Deviation|Mean
1370850|NCT01558700|Primary|Change in Brain Gray Matter Volume|The change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline)|16 weeks compared to baseline||||percentage of change||Standard Deviation|Mean
1370851|NCT01558674|Secondary|Apparent Terminal Half-life (t1/2) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the t1/2.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
1370852|NCT01558674|Secondary|Time to Cmax (Tmax) of MK-7145(Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Tmax.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
1370853|NCT01558674|Secondary|Trough Plasma Concentration (Ctrough) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Ctrough.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
1370854|NCT01558674|Secondary|Maximum Plasma Concentration (Cmax) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 2-4 to determine the Cmax.|up to 24 hours post morning dose on up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
1370855|NCT01558674|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3-4 to determine the AUC0-24hr|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
1370856|NCT01558674|Secondary|Serum Creatinine Measured at 24 Hours Post Last Morning Dose of Each Period (Part 2)|Blood samples were collected at 24 hours post last morning dose of each period to determine serum creatinine levels|Day 15 for Periods 1, 2, and 3; Day 29 for Period 4|No participants were enrolled in Part 2 of the study.||||||
1372766|NCT01536067|Secondary|Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0|Maximum grade per participant of any AE.|Every 30 days for 2 months|All treated and eligible patients|||participants|||Number
1370857|NCT01558674|Secondary|Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The t1/2 was calculated.|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145 and who complied with the protocol sufficiently and had data available for endpoint. t1/2 could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted.|||hours||95% Confidence Interval|Median
1370858|NCT01558674|Secondary|Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The time to Cmax (Tmax) calculated for Treatment Days 1 and 5|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145 who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted.|||hours||Full Range|Median
1370859|NCT01558674|Secondary|Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Ctrough for was calculated for Treatment Days 1 and 5|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Ctrough for MK-7145 8 mg arm could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted.|||nM||Geometric Coefficient of Variation|Geometric Mean
1370860|NCT01558674|Secondary|Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Cmax was calculated for Treatment Days 1 and 5.|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted|||nM||Geometric Coefficient of Variation|Geometric Mean
1370861|NCT01558674|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Day 4 (Treatment Day 1) through Day 8 (Treatment Day 5) at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96, 101, 104, 106, 108, 110 and 120 hours (relative to Day 4 dosing). The AUC0-24 was calculated for Days 1 and 5|up to 24 hours post-dose on Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
1370862|NCT01558674|Secondary|Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1)|Blood was collected predose on Treatment Day 1 and at 24 hours post morning dose on Treatment Day 5 to determine serum creatinine levels. Creatinine levels were log transformed and then fold change from baseline was calculated.|Baseline (predose Treatment Day 1) and 24 hours post morning dose on Treatment Day 5 of each treatment period (Part I)|All participants who received at least 1 dose of study drug , who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted.|||mg/dL||95% Confidence Interval|Geometric Mean
1370863|NCT01558674|Primary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Values at 24 Hours Post Last Morning Dose of Each Period (Part 2)|B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. Levels of BNP levels were assessed 24 hours post last morning dose of study drug for each treatment period.|Day 15 for Periods 1, 2, and 3; Day 29 for Period 4|Part 2 of the study was not conducted. No participants were enrolled.||||||
1370864|NCT01558674|Primary|Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1)|Urine was collected at Treatment Day -1 and Treatment Day 1 at 0-2, 2-4, 4-6, 6-8, 8-12, 12-24 hour. The 24-hour cumulative natriuresis will be estimated by the amount of sodium excreted into urine over 24 hour period postdose, where amount of sodium is the product of sodium concentration and the volume of urine. The change from baseline in UNa from baseline (Treatment Day -1) and 24 hours post-dose on Treatment Day 1 were calculated.|Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment period|All participants who received at least 1 dose of study drug and who complied with the protocol sufficiently. One participant did not participate for several time intervals on Period 2: Day 8 due to being unwell, and data from this day of this participant were excluded from the analysis. Part 1: Period 3 was not conducted.|||mEq||95% Confidence Interval|Least Squares Mean
1370865|NCT01558661|Secondary|Number of Participants With Next Generation Sequencing (NGS)|Next generation sequencing the t(6;9) translocation (MYBNFIB gene product) status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response. The number of participants with NGS will be recorded.|2 years|One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival.|||Participants|||Count of Participants
1370866|NCT01558661|Secondary|MYB Immunohistochemistry (IHC)||2 years|MYB immunohistochemistry (IHC) was carried out on tumors from 33 patients. MYB quantification was assessed as: 2+ for strong staining in >50% of cancer cells, 1+ for weak or strong staining in <50% of the cells and 0 for <5% staining.|||Participants|||Count of Participants
1370881|NCT01558271|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks|Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||participants|||Number
1370867|NCT01558661|Secondary|Median Progression-free Survival (PFS).|"Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|2 years|One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival.|||months||95% Confidence Interval|Median
1370868|NCT01558661|Primary|Overall Response Rate|Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|2 years|One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not for Progression Free Survival.|||Participants|||Count of Participants
1370869|NCT01558596|Primary|Troponin I Elevation Above the Upper Reference Limit (URL)|Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period|Within 3 days of the vascular operation||||participants|||Number
1370870|NCT01558492|Secondary|Change in Survival Status||6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.||||||
1370871|NCT01558492|Primary|Change in Tumor Size|Assessed by CT or MRI scan and/or bone scan.|Baseline, week 12, week 24 and end of study.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.||||||
1370872|NCT01558492|Primary|Change in Prostate-specific Antigen (PSA) Level||Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.||||||
1370873|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).|6 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.|||pounds||Standard Deviation|Mean
1370874|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 3 months after first treatment session.|3 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.|||pounds||Standard Deviation|Mean
1370875|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 1.5 months after first treatment session.|1.5 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.|||pounds||Standard Deviation|Mean
1370876|NCT01558271|Secondary|Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks|Fridericia Corrected QT (QTcF) Interval and PR Interval are summarized. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means were calculated using ANCOVA model with treatment as a fixed effect and the baseline ECG parameter as the covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable ECG data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milliseconds (msec)||Standard Error|Least Squares Mean
1370877|NCT01558271|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26 and 52 weeks.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||participants|||Number
1370878|NCT01558271|Secondary|Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks|A participant was considered to have treatment-emergent LY2189265 ADAs if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from the baseline measurement.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication and had LY2189265 evaluable ADA data.|||participants|||Number
1370879|NCT01558271|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks||Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable serum calcitonin data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms/milliliter||Inter-Quartile Range|Median
1370880|NCT01558271|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks|Pancreatic enzyme (lipase and total amylase) concentrations were measured.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pancreatic enzyme data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units/liter||Inter-Quartile Range|Median
1370882|NCT01558271|Secondary|Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable blood pressure data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milliliters of mercury (mmHG)||Standard Error|Least Squares Mean
1370883|NCT01558271|Secondary|Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks|Sitting pulse rate was measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline pulse rate as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pulse rate data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1370884|NCT01558271|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||participants|||Number
1370885|NCT01558271|Secondary|30-Day Rate of Hypoglycemic Episodes|The 30-day total hypoglycemia rate over 26 weeks and 52 weeks of treatment is summarized. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication. One participant in the Liraglutide reporting group received study drug but discontinued from the study on the same day and, therefore, was not included in the analysis.|||events per participant per 30 days||Standard Deviation|Mean
1370886|NCT01558271|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week or 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||percentage of participants|||Number
1370887|NCT01558271|Secondary|Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in beta-cell function was assessed based on change from baseline of HOMA2-%B using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%B as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%B data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.|||percentage of HOMA2||Standard Error|Least Squares Mean
1370888|NCT01558271|Secondary|Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in insulin sensitivity was assessed based on change from baseline of HOMA2-%S using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%S as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%S data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.|||percentage of HOMA2||Standard Error|Least Squares Mean
1370889|NCT01558271|Secondary|Change From Baseline in Body Weight at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
1370900|NCT01558089|Secondary|Change From Baseline in Patient’s Assessment of General Health (VAS) at Visit 4 (Month 6)|The patients used a 100 mm Visual Analogue Scale (VAS) to score their general health during the last week. The scale ranged from 0 (no pain) to 100 mm (severe pain)|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||mm||Standard Deviation|Mean
1372767|NCT01536067|Secondary|Duration of Response||From the observation of a response to the time of disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1370890|NCT01558271|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, and at bedtime. LS means were calculated using analysis of covariance (ANCOVA) model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline SMBG as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1370891|NCT01558271|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable FBG data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1370892|NCT01558271|Secondary|Percentage of Participants Who Achieved HbA1c <=6.5% or <7%|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% at Week 26 and Week 52 was analyzed with a Cochran-Mantel-Haenszel test stratified by prestudy therapy (OAM yes/no) and baseline BMI group (<25 or >=25 kg/m^2).|Up to 26 and 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.|||percentage of participants|||Number
1370893|NCT01558271|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 52 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
1370894|NCT01558271|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication [OAM] yes/no), baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
1370895|NCT01558128|Primary|Subject Rhythm|Measuring change from baseline cardiac rhythm.|Participants will be followed for the duration of their hospital stay post surgery with an expected average of 7 to 10 days and again at surgical follow up appointment up to 6 weeks.|Converted to normal sinus rhythm|||Participants|||Count of Participants
1370896|NCT01558089|Secondary|Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)|In a first step a univariate logistic regression model was fit for the following baseline variables: DAS28 (n=48), Physician’s Global Assessment of Disease Activity (VAS) (n=47), Patient’s Global Assessment of Disease Activity (VAS) (n=47), CRP (n=46), Patient Pain (VAS) (n=47), HAQ-DI (n=47), EQ-5D (n=47). Only those variables that were significant at a 10% level were then included in the second step: a multivariate analysis with stepwise regression (entry level=10%, stay level=5%). The final model presented in the Basic Results table displays those covariates which were significant at the 2-sided 5% level (baseline value for DAS28; n=48). Note that DAS28 is not a categorical variable; therefore no stratified results for this variable are presented.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||Odds Ratio (per unit increase)||95% Confidence Interval|Number
1370897|NCT01558089|Secondary|Change From Baseline in HAQ-DI at Visit 4 (Month 6)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is composed of 20 items. It is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score ranges from 0-3: 0=least difficulty and 3=extreme difficulty.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||units on scale||Standard Deviation|Mean
1370898|NCT01558089|Secondary|Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)|The European Quality of Life–5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||units on scale||Standard Deviation|Mean
1370899|NCT01558089|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)||Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||mm/hour||Standard Deviation|Mean
1370901|NCT01558089|Secondary|Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was ‘Present’. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||Joints||Standard Deviation|Mean
1370902|NCT01558089|Secondary|Change From Baseline in Tender Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was ‘Present’. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the Full Analysis Set (FAS) population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||Joints||Standard Deviation|Mean
1370903|NCT01558089|Primary|Primary: Participants With EULAR (Good)|Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 >5.1|Visit 4 (Month 6)|Last observation carried forward (LOCF) was applied where data were available. Participants where a EULAR response value could not be calculated, were omitted from the analysis. Only 48 Participants had available EULAR response data at 6 months.|||participants|||Number
1370904|NCT01557959|Secondary|Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||2 years||||Months||Standard Error|Median
1370905|NCT01557959|Secondary|Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Pre-specified that data is only presented for the subgroups Low Cyclin D1 and High Cyclin D1."|2 years||||Participants|||Count of Participants
1370906|NCT01557959|Primary|Time to Progression|Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2 years||||months||95% Confidence Interval|Median
1370907|NCT01557946|Secondary|Mean Difference From Baseline to Day 7 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group|Estimated mean difference (day 7 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 7 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.|Change from baseline to day 7|One participant's day 7 scan was corrupted during data transfer and could not be recovered. Results are only presented for participants with depression as healthy control participants were only scanned once.|||arbitrary units||Standard Error|Mean
1370908|NCT01557946|Primary|Mean Difference From Baseline to Day 3 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group|Estimated mean difference (day 3 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 3 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.|Change from Baseline to Day 3|One participant lacked a day 3 scan; one participant's day 3 scan was corrupted during data transfer and could not be recovered; and one participant's day 3 scan data was judged to be unusable due to poor spectral quality. Results are only presented for participants with depression as healthy control participants were only scanned once.|||arbitrary units||Standard Error|Mean
1370909|NCT01557920|Post-Hoc|Frequency of Spontaneous Swallows During Anesthesia vs Wakefulness|The number of swallows were counted during wakefulness and anesthesia. The frequency of swallowing was calculated per hour|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows). If the pathological swallow incidence between sevoflurane and propofol anesthesia had a p-value >0.05, subsequent analyses were conducted to evaluate depth of anesthesia related differences rather than compound specific ones.|||number of swallows/hr||Standard Deviation|Mean
1370910|NCT01557920|Secondary|Duty Cycle|(T(ins)/T(total))*100|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of Duty cycle.|||percentage of Ttotal||Standard Deviation|Mean
1370911|NCT01557920|Secondary|Minute Ventilation (Tidal Volume and Respiratory Rate)|Measured by spirometry. Subjects wear a full-face mask. Reported in L/min|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of minute ventilation.|||L/min||Standard Deviation|Mean
1370912|NCT01557920|Secondary|Genioglossus Muscle Electromyogram|will be measured during steady state anesthesia as well as during carbon dioxide reversal, and during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|The number of participants in this group are only 9 since the genioglossus EMG signals were poor in 2 participants and these were excluded from the analysis.|||percentage of maximum recorded activity||Standard Error|Mean
1370914|NCT01557920|Primary|Proportion of Pathological Swallows|A pathological swallow was defined as a swallow that was followed by inspiratory flow. A physiological swallow was defined as a swallow that was followed by expiratory flow. The number of pathological and physiological swallows were measured during wakefulness and anesthesia. The pathological swallows are presented as percentage of path. swallows calculated as path.sw/[path.sw+phys.sw]*100 (%).|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows).|||percentage of pathological swallows|||Number
1370915|NCT01557920|Primary|Upper Airway Closing Pressure|Upper airway closing pressure will be measured during steady state anesthesia as well as during carbon dioxide reversal.|participants will be followed for the duration of anesthesia, an expected average of 6 hours|Ten out of 12 subjects were analyzed. In two subjects we could not record high quality biologically plausible recordings of upper airway closing pressure. Data from multiple measurements per participant were combined to calculate an average upper airway closing pressure per subject.|||cm H20||Standard Deviation|Mean
1370916|NCT01557894|Secondary|Anxiety Sensitivity Index (ASI)|The Anxiety Sensitivity Index (ASI) is a 16-item questionnaire that measures the beliefs about the social and somatic consequences of anxiety symptoms. The total ASI score ranges from 0 to 64, with higher scores corresponding to greater anxiety sensitivity.|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
1370917|NCT01557894|Secondary|Attitude and Belief Scale-II (ABS-II)|"The Attitude and Belief Scale-II (ABS-II) measures rational and irrational thinking as described by Albert Ellis. The scale was designed to capture four cognitive processes (i.e., demandingness, awfulizing, low frustration tolerance, and self-downing/global evaluation) in three content areas (i.e., achievement, approval, and comfort). We selected the 72-item ABS-II because preliminary psychometrics are available for the Romanian population.~The total ABS-II score range from 0 to 360, with higher scores corresponding to greater irrationality."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
1370918|NCT01557894|Secondary|Beck Depression Inventory-II (BDI-II)|"Beck Depression Inventory-II (BDI-II) is a 21-item self-report inventory widely used to assess DSM-IV depressive symptoms. Each item consists of four statements, scored 0–3, indicating increasing symptom severity.~Thus, for BDI-II the range of scores is 0-63, with higher scores reflecting higher levels of depression."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
1370919|NCT01557894|Primary|Social Phobia Inventory (SPIN)|"The Social Phobia Inventory (SPIN) is a brief (i.e., 17-item) self-report instrument measuring fear in social situations, avoidance of performance/social events, and physiological discomfort in social situations. Each item is rated on a 4-point scale.~Thus, for SPIN the range of scores is 0-68, with higher scores reflecting higher levels of social anxiety symptomatology"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
1370920|NCT01557894|Primary|Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)|"The Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) measures social anxiety.~LSAS-SR presents 24 commonly anxiety-provoking situations, and asks participants to rate their fear and avoidance for each situation.~In order to obtain the total LSAS-SR score the Anxiety and Avoidance subscales scores are added together.~The LSAS-SR total score ranges from 0-144, with higher scores corresponding to greater social anxiety"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
1370921|NCT01557868|Secondary|Visual Analogue Scale (VAS) at 6 Months|The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement.|Assessments were at baseline to 6 month follow-up|The discrepancy between the number of subjects included in this analysis (140) and the number of subjects reported completing the study (141) is due to a missing values for one subject for this variable.|||units on a scale||Standard Deviation|Mean
1370922|NCT01557868|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale|"The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the best score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline."|Baseline and at 6 month follow-up||||units on a scale||Standard Deviation|Mean
1370923|NCT01557842|Primary|Cardiac-related Death|Subjects with cardiac-related death|2 years follow up|All enrolled subjects|||percentage of participants|||Number
1370924|NCT01557842|Primary|Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events|The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.|From one month to 2 years follow up|All enrolled subjects|||percentage of participants|||Number
1370925|NCT01557751|Primary|NRS-Pain With Movement on POD 2|"The primary endpoint is the pain reported by subjects, using the NRS-Pain with movement on the second day after surgery.The assumption behind this study is that certain genetic variants (e.g. single-nucleotide polymorphism (SNP) are responsible for part of total variation of certain clinical phenotypes (e.g. post-operative pain here).~Numeric Rating Score Pain Assessment (0-10 scale where 0 indicates no pain at all and 10 indicates the worst pain imaginable) on Post Op Day 2, Pain with Movement"|Postoperative day (POD) 2||||units on a scale||Full Range|Mean
1370926|NCT01557699|Secondary|Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84|Geometric Mean Titre by Plaque Reduction Neutralization Test were assessed on Day -7, 28 and 84 at CDC, Atlanta. Titers are expressed as IU/ml.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||IU/ml||95% Confidence Interval|Geometric Mean
1370927|NCT01557699|Secondary|Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies|Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies were measured on Day -7, Day 28 and Day 84 by ELISA using Trinity ELISA Kits for Measles.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||IU/ml||95% Confidence Interval|Geometric Mean
1370928|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for PRNT|The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||percentage of participants|||Number
1370929|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG|The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.|||percentage of participants|||Number
1370930|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre|The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.|||percentage of participants|||Number
1370931|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies|The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||percentage of participants|||Number
1370932|NCT01557699|Primary|Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions|Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.|Day 180|Intention-To-Treat (ITT) Population was used for safety and immunogenicity analysis. ITT population included subjects who had blood drawn to confirm a measles protective titer at Day -7 and met all inclusion/ exclusion criteria and did not receive a vaccine forbidden in the study protocol within the previous 30 days.|||participants|||Number
1370933|NCT01557699|Primary|Incidence of Unsolicited Adverse Events Within 84 Days|Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.|Day 84|Intention-To-Treat (ITT) Population was used for safety analysis.|||participants|||Number
1370934|NCT01557699|Primary|Incidence of Solicited Reactions|Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.|Day 14|Intention-To-Treat (ITT) Population included all subjects who received at least one dose of study vaccine and had at least one post-baseline assessment, regardless of whether they adhered to the study eligibility criteria or whether their study medication administration and study procedure visits are within the protocol-specified windows.|||participants|||Number
1370935|NCT01557595|Primary|Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline|The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality. The PSQI is considered appropriate in identifying “new-onset” insomnia in the clinical setting.|2 weeks post baseline||||units on a scale||Standard Deviation|Mean
1370936|NCT01557582|Secondary|Intra-Observer Variability|Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.||||Percent difference||Standard Deviation|Mean
1370937|NCT01557582|Secondary|Inter-Observer Variability|A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|All evaluable subjects.|||Percent difference||Standard Deviation|Mean
1370938|NCT01557582|Primary|Observed Mean (Std Err) for % Difference Between VMS and MRI.|% Difference was measured for right ventricular EDV, ESV and EF.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|Only evaluable participants were analyzed|||Percent difference||Standard Error|Mean
1370939|NCT01557569|Primary|Time Till Relapse|The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse)|57 days|Only 4 of 13 finished the 2-week residential stay. Since subjects who drop out are deemed relapsed, all subjects receiving >/=1 dose of study med were included in the analyses. Those who dropped out before completing the residential stay were considered relapsed by the second day and the date of discharge was subtracted from this relapse date.|||Days to Relapse||Full Range|Median
1370940|NCT01557504|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.|Up to 9 days|All participants as treated defined as all participants who received at least one dose of study drug.|||Participants|||Number
1370942|NCT01557504|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.|||Participants|||Number
1370943|NCT01557504|Primary|Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||Hour||Geometric Coefficient of Variation|Geometric Mean
1370944|NCT01557504|Primary|Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||Hour||Full Range|Median
1370945|NCT01557504|Primary|Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1370946|NCT01557504|Primary|Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM||Geometric Coefficient of Variation|Geometric Mean
1370947|NCT01557504|Primary|Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
1370948|NCT01557504|Primary|AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1370949|NCT01557504|Primary|AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
1370950|NCT01557504|Primary|Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours (hrs) prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hrs post study drug administration. Owing to resumption of therapeutic metformin administration 24 hrs after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and area under the curve 0 to 24 hrs (AUC0-24hr). Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
1370951|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 9|The Swallowing Ability Questionnaire was completed on Day 9 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 9|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 9, all participants received matching placebo, so the two treatment groups were pooled on Day 9.|||Participants|||Number
1370961|NCT01557348|Secondary|Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy|Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.|Month 6 and Month 12|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (i.e,Treatment Group) and reason for changing biologic therapy was known.|||Percentage of participants|||Number
1370952|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 6|The Swallowing Ability Questionnaire was completed on Day 6 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 6|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 6, all participants received matching placebo, so the two treatment groups were pooled on Day 6.|||Participants|||Number
1370953|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 4|The Swallowing Ability Questionnaire was completed on Day 4 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 4|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 4, all participants received matching placebo, so the two treatment groups were pooled on Day 4.|||Participants|||Number
1370954|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2|The Swallowing Ability Questionnaire was completed on Day 2 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 2|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 2, all participants received matching placebo, so the two treatment groups were pooled on Day 2.|||Participants|||Number
1370955|NCT01557348|Secondary|Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi|The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors.|Baseline|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.|||participants|||Number
1370956|NCT01557348|Secondary|Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy|The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.|||participants|||Number
1370957|NCT01557348|Secondary|Number of Participants With Previous TNFi Therapy|The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.|||participants|||Number
1370958|NCT01557348|Secondary|Number of Participants With Reasons for Discontinuation of the First TNFi Therapy|The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.|||participants|||Number
1370959|NCT01557348|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death|An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to 12 Months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.|||participants|||Number
1370960|NCT01557348|Secondary|Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice||Up to 12 months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (ie,Treatment Group) and reason for changing biologic therapy was known.|||Number of participants|||Number
1370992|NCT01557322|Primary|Time Since Recalled Symptom Onset|RA symptoms include joint pain, stiffness, and swelling.|Baseline|Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis.||||||
1370962|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||minutes||Standard Error|Least Squares Mean
1370963|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||scores on a scale||Standard Error|Least Squares Mean
1370964|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Participant’s VAS Pain Score at Months 6 and 12|Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as “no pain” and the right edge (100 mm) defined as “severest pain”. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm||Standard Error|Least Squares Mean
1370965|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12|Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm||Standard Error|Least Squares Mean
1370966|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12|Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm||Standard Error|Least Squares Mean
1370967|NCT01557348|Secondary|Least Squares Mean Change From Baseline in ESR at Months 6 and 12|The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm/hr||Standard Error|Least Squares Mean
1370968|NCT01557348|Secondary|Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12|C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||milligram/Liter||Standard Error|Least Squares Mean
1370969|NCT01557348|Secondary|Least Squares Mean Change From Baseline in SJC at Months 6 and 12|The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||swollen joints||Standard Error|Least Squares Mean
1370970|NCT01557348|Secondary|Least Squares Mean Change From Baseline in TJC at Months 6 and 12|The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||tender joints||Standard Error|Least Squares Mean
1370993|NCT01557322|Primary|Time Since First Rheumatologist Visit||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||years||Standard Error|Mean
1370971|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.|||scores on a scale||Standard Error|Least Squares Mean
1370972|NCT01557348|Primary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.|||scores on a scale||Standard Error|Least Squares Mean
1370973|NCT01557322|Other Pre-specified|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 6|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
1370974|NCT01557322|Other Pre-specified|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
1370975|NCT01557322|Other Pre-specified|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Mean
1370976|NCT01557322|Other Pre-specified|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, acute phase reactants (ESR, millimeters per hour or CRP, milligram per liter) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Mean
1370977|NCT01557322|Other Pre-specified|Number of Participants Who Died or Hospitalized Due to Adverse Events|Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
1370978|NCT01557322|Other Pre-specified|Number of Participants With Malignancy|Malignancy included lymphoproliferative tumors, Hodgkins lymphoma, myeloma, leukaemia, non-melanoma skin cancer, and solid tumor. Number of participants with each of these malignancies is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
1370979|NCT01557322|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline.|||participants|||Number
1370994|NCT01557322|Primary|Duration of Disease (Rheumatoid Arthritis)||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||years||Standard Error|Mean
1370980|NCT01557322|Primary|Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment|Direct costs included: outpatient costs, physician visits, outpatient surgery, emergency room visits, visits to healthcare professionals other than physicians, medications, diagnostic and/or therapeutic procedures, medical devices, inpatient costs, admission to acute-care nonsurgical departments, admission to acute-care surgical departments, admission to extended-care facilities, and other direct costs (travel expenses, home care, home remodeling, medical devices, non-physician healthcare professionals, alternative medicine practitioner, participant time). Indirect cost (related to lost productivity through morbidity and death) included: lost productivity in employed participants (disability, sick-leaves), lost opportunities (lost productivity in family members caring for the patient, disability requiring changes to everyday activities), and lost wages.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.||||||
1370981|NCT01557322|Primary|Number of Rheumatoid Arthritis (RA) Related Visits|Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.||||||
1370982|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.||||||
1370983|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.||||||
1370984|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 60|Result not reported as no participants were evaluable at this time-point.||||||
1370985|NCT01557322|Primary|Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60|The pain VAS is a horizontal line; 100 millimeter (mm) in length, self-administered by the participant to rate pain from 0 mm (no pain) to 100 mm (worst possible pain).Change = mean scores at observation minus mean scores at baseline.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
1370986|NCT01557322|Primary|Time to Therapeutic Goal|Therapeutic goal achievement was based on physician’s discretion.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
1370987|NCT01557322|Primary|Time to Disease Worsening|Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
1370988|NCT01557322|Primary|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
1370989|NCT01557322|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
1370990|NCT01557322|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
1370991|NCT01557322|Primary|Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs)|Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline.|||participants|||Number
1370995|NCT01557322|Primary|Change From Baseline in Patient’s Global Assessment (PtGA) of Disease Activity at Month 60|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||mm||Standard Error|Mean
1370996|NCT01557322|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||mm/hour||Standard Error|Mean
1370997|NCT01557322|Primary|Change From Baseline in C-Reactive Protein (CRP) Level at Month 60|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is <10 milligram/liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||mg/L||Standard Error|Mean
1370998|NCT01557322|Primary|Change From Baseline in Swollen Joints Count (SJC) at Month 60|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||swollen joints||Standard Error|Mean
1370999|NCT01557322|Primary|Change From Baseline in Tender Joints Count (TJC) at Month 60|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||tender joints||Standard Error|Mean
1371000|NCT01557322|Primary|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, acute phase reactants (erythrocyte sedimentation rate [ESR, millimeters per hour] or C-reactive protein [CRP, milligram per liter]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
1371001|NCT01557322|Primary|Blood Pressure (BP)|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively."|||millimeter of mercury (mmHg)||Standard Error|Mean
1371002|NCT01557322|Primary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||kg/m^2||Standard Error|Mean
1371003|NCT01557322|Primary|Number of Participants With Comorbidities|Comorbidities included: hypertension, moderate or severe heart failure, angina, stroke, epilepsy, asthma, chronic bronchitis/emphysema, peptic ulcer, tuberculosis, pre-existing or recent onset of central nervous system demyelinating disorders, chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis, active tuberculosis, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease, malignancy or history of malignancy, hyperthyroidism, depression and/or anxiety, recent substance abuse (drug or alcohol), human immunodeficiency virus (HIV) infection or active hepatitis B/C infection (including associated chronic active hepatitis). Participants suffering from any of the comorbidity are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
1371004|NCT01557322|Primary|Number of Participants With Chest X-Ray Prior to New Therapy||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1371016|NCT01557166|Secondary|Change From Baseline in Fasting Plasma Glucose|Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 355 subjects contributed to the statistical analysis.|||mmol/L||Standard Deviation|Mean
1371005|NCT01557322|Primary|Number of Participants With Prior Joint Replacement or Surgery|Participants who had prior total knee replacement, total hip replacement, total shoulder replacement, total elbow replacement, wrist/hand/ankle/foot surgery, and neck surgery are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1371006|NCT01557322|Primary|Number of Participants With Systemic Features|Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified).|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
1371007|NCT01557322|Primary|Number of Participants With American College of Rheumatology (ACR) Criteria|ACR criteria: 1) Morning stiffness: in and around joints, lasting at least (>=) 1 hour; 2) Arthritis/deformity of >=3 joint areas: presence of soft tissue swelling or fluid (not bony overgrowth alone), 14 possible areas are right/left proximal interphalangeal (PIP), metacarpophalangeal (MCP), wrist, elbow, knee, ankle, metatarsophalangeal (MTP) joints; 3) Arthritis of hand joints: >=1 area swollen in wrist, MCP, PIP joint; 4) Symmetric arthritis: simultaneous involvement of same joint areas (as defined in 2) on both sides of body; 5): Rheumatoid nodules: subcutaneous nodules over bony prominences or extensor surfaces or in juxtaarticular regions; 6): Rheumatoid factor (RF): abnormal amounts of RF by any method for which result has been positive in <5% of normal control participants; 7) Radiographic changes: typical of RA on posteroanterior hand and wrist radiographs, which must include erosions/unequivocal bony decalcification localized in or most marked adjacent to involved joints.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1371008|NCT01557283|Other Pre-specified|Number of Participants Who Received Intermittent Treatment|Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1371009|NCT01557283|Other Pre-specified|Number of Participants Who Received Continuous Treatment|Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist’s discretion was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1371010|NCT01557283|Secondary|Number of Participants With Reasons for Treatmant Discontinuation|Number of participants who discontinued etanercept before completing the study was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.|||participants|||Number
1371011|NCT01557283|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.|||percentage of BSA||Standard Deviation|Mean
1371012|NCT01557283|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1371013|NCT01557283|Secondary|Number of Weeks of Off-Treatment|Total duration of time in weeks for which participants discontinued etanercept treatment was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||weeks||Standard Deviation|Mean
1371014|NCT01557283|Primary|Number of Weeks of Etanercept Treatment|Average duration of time in weeks for treatment with etanercept was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.|||weeks||Standard Deviation|Mean
1371015|NCT01557166|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 345 subjects contributed to the statistical analysis|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1371018|NCT01557166|Primary|Change From Baseline in Apnoea-hypopnoea Index (AHI)|Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0−14.9; moderate 15.0−29.9; severe ≥30.0 events/hour.|Week 0, Week 32|Full analysis set (FAS) - included all randomised subjects. 334 subjects contributed to the statistical analysis.|||events/hour||Standard Deviation|Mean
1371019|NCT01556997|Secondary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).||Day 0 to Day 42|The Analysis Population for the Secondary Outcome (Change from baseline to end of treatment in the mean seated trough cuff systolic blood pressure (SBP)) consists of the Intent-to-treat population for the study|||mmHg||Standard Deviation|Mean
1371020|NCT01556997|Primary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).||Day 0 to Day 42|The Analysis Population for the Primary Outcome (Change from baseline to end of treatment in the mean seated trough cuff diastolic blood pressure (DBP)) consists of the Intent-to-treat population for the study|||mmHg||Standard Deviation|Mean
1371021|NCT01556932|Primary|The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.|The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a “prn” (as needed) gel in actual practice, when relief is needed in short order.|60 minutes after application|25 participants were consented, two subjects declined treatment, one expired subject. Two subjects refused to continue after first treatment and did not complete the second treatment. Only 20 patients were analyzed because of missing data not done by those two subjects on the second treatment.|||units on a scale||Standard Deviation|Mean
1371022|NCT01556906|Secondary|Absolute Change From Baseline in Linoleic Acid (LA)|Absolute Change From Baseline in LA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
1371023|NCT01556906|Secondary|Absolute Change From Baseline in Docosahexaenoic Acid (DHA)|Absolute Change From Baseline in DHA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
1371024|NCT01556906|Secondary|Absolute Change From Baseline in Eicosapentaenoic Acid (EPA)|Absolute Change From Baseline in EPA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
1371025|NCT01556906|Secondary|Absolute Change From Baseline in Alpha Linoleic Acid (ALA)|Absolute Change From Baseline in ALA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
1371026|NCT01556906|Secondary|Absolute Change From Baseline in Ratio of Vitamin E to Total Lipids|Absolute Change From Baseline in ratio of vitamin E to total lipids|Baseline and 16 weeks of treatment|All patients treated|||ratio||Standard Deviation|Mean
1371027|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin D|Absolute Change From Baseline in Vitamin D|Baseline and 16 weeks of treatment|All patients treated|||nmol/L||Standard Deviation|Mean
1371028|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin E|Absolute change from Baseline in vitamin E|Baseline and 16 weeks of treatment|All patients treated|||umol/L||Standard Deviation|Mean
1371029|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin A|Absolute change from Baseline in vitamin A|Baseline and 16 weeks of treatment|All patients treated|||µmol/L||Standard Deviation|Mean
1371030|NCT01556906|Secondary|Absolute Change From Baseline in Carbon Monoxide Lung Diffusing Capacity (DLCO)(a Pulmonary Function Test)|Absolute change from Baseline in DLCO|Baseline and 16 weeks of treatment|All patients treated|||mL CO/min/mm Hg||Standard Deviation|Mean
1371031|NCT01556906|Secondary|Absolute Change From Baseline in Forced Expiratory Volume During 1 Second (FEV1)|Absolute change from Baseline in FEV1|Baseline and 16 weeks of treatment|All patients treated|||Liters||Standard Deviation|Mean
1371032|NCT01556906|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and 16 weeks of treatment|All patients treated|||percent of hapatic fat||Standard Deviation|Mean
1371033|NCT01556906|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and 16 weeks of treatment|All patients treated|||mg/dL||Standard Deviation|Mean
1371034|NCT01556906|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and 16 weeks of treatment|All patients treated|||U/L||Standard Deviation|Mean
1371035|NCT01556906|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and 16 weeks of treatment|All patients treated|||U/L||Standard Deviation|Mean
1371036|NCT01556906|Primary|LDL-C|Percent change in LDL-C compared to Baseline.|Up to 16 weeks of treatment comapred to Baseline|All patients treated|||percentage change in LDL-C||Standard Deviation|Mean
1371037|NCT01556763|Secondary|P300 Peak Amplitude|P300 auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the peak amplitude over 250-500 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -0.4 to 1.2 microvolts. Normalization is suggested by a more positive value.|Days -1 to 20|Subjects providing valid and measurable P300 responses.|||microvolts||Standard Error|Mean
1371038|NCT01556763|Secondary|MMN Summed Amplitude|Mismatch negativity (MMN) auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the voltage difference over 100-200 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -1.2 to 0.2 microvolts. Normalization is suggested by a more negative value.|Days -1 to 20|Subjects providing valid and measurable MMN responses.|||microvolts||Standard Error|Mean
1371263|NCT01553318|Secondary|Fibromyalgia Impact Questionnaire|Change in global symptom severity [scale range from -100 to +100] = the more negative the value is, the greater the improvement in overall symptom severity|baseline and week 10|Indeed, fibromyalgia impact questionnaire is a secondary outcome.|||units on a scale||Standard Deviation|Mean
1371039|NCT01556763|Secondary|P50 Amplitude Difference|P50 auditory evoked potential response (amplitude measured in microvolts) using sensory gating paradigm. Measured by EEG as amplitude difference (conditioning stimulus minus test stimulus). Plotted on a scale of -0.2 to 0.8 microvolts. Normalization is suggested by a higher value.|Days -1 to 20|Subjects providing valid and measurable P50 responses.|||microvolts||Standard Error|Mean
1371040|NCT01556763|Secondary|N100 Gating Ratio|N100 auditory evoked potential response (amplitude measured in microvolts) using the sensory gating paradigm. Measured by electroencephalography (EEG) as the amplitude ratio of test stimulus to conditioning stimulus. Plotted on a unitless scale of 0 to 2. Normalization is suggested by a lower value.|Days -1 to 20|Subjects providing valid and measurable N100 responses.|||ratio||Standard Error|Mean
1371041|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving paliperidone/risperidone for whom blood samples were available for analysis.|||hr||Standard Deviation|Mean
1371042|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.|||pg*hr/ml||Standard Deviation|Mean
1371043|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.|||hr||Full Range|Median
1371044|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.|||pg/mL||Standard Deviation|Mean
1371045|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving aripiprazole for whom blood samples were available for analysis.|||hr||Standard Deviation|Mean
1371046|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.|||pg*hr/mL||Standard Deviation|Mean
1371047|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.|||hr||Full Range|Median
1371048|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole|Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.|||pg/mL||Standard Deviation|Mean
1371049|NCT01556763|Primary|Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.|Safety and tolerability was measured by number of reported adverse events (serious and non-serious) and repeated clinical evaluation of physical examinations, vital signs, 12-lead electrocardiogram (ECG), 24-hour continuous cardiac monitoring, and laboratory tests (hematology/blood chemistry/urinalysis).|Screening (Day -5 for continuous cardiac monitoring) to Day 22|All randomized patients who ingested at least one dose of study drug or placebo.|||participants|||Number
1371050|NCT01556724|Secondary|Number of Participants With Decreased Infusion Rates|Number of patient requiring decreased infusion rates decreased to 5 mL/hour due to increased motor blockade.|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)|Number of patient requiring decreased infusion rates.|||Participants|||Count of Participants
1371051|NCT01556724|Secondary|Number of Participants With Increased Infusion Rates|Number of patients requiring increased infusion rates to 9 mL/hour to better optimize pain control.|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)|The number of participants with requiring increased infusion rates.|||Participants|||Count of Participants
1371052|NCT01556724|Secondary|Numeric Rating Scale Pain Score With Movement at 24 Hours|Numeric rating scale (NRS) pain score with movement were assessed at 24 hours. Pain scores were followed using an 11-point NRS (0 = no pain and 10 = worst imaginable pain). Scores at 24 hours were not averaged with any other scores.|24 hours postoperatively|NRS pain scores at 24 hours postoperatively at rest and in movement.|||units on a scale||95% Confidence Interval|Median
1371053|NCT01556724|Secondary|Patient Satisfaction With Pain Control|Patient satisfaction with pain control at 24 hours (0-10 scale). Patients’ satisfaction was assessed using an 11-point numeric scale (0–10, 0 = unsatisfied and 10 = very satisfied). Scores at 24 hours were not averaged with any other scores.|24 hours postoperatively|Patient satisfaction with pain control at 24 hours.|||units on a scale||95% Confidence Interval|Median
1371054|NCT01556724|Primary|Opiate Consumption Postoperatively|Postoperative opiate consumption at 24 hours|24 hours postoperatively|Forty-one patients signed informed consent and underwent primary THA. Eleven patients were excluded: six for inability to achieve <0.5mA quadriceps stimulation for lumbar plexus block and five for general anesthesia. The study was completed after pharmacy randomization 30 patients: 16 in 0.2% and 14 in 0.1% group.|||mg||95% Confidence Interval|Mean
1371055|NCT01556633|Secondary|Number of Participants With Abnormal Shifts in Vital Signs|"Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature.~Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as <=70 mmHg (SBP) and <=40 mmHg (DBP); high blood pressure defined as >=140 mmHg (SBP) and >=90 mmHg (DBP); low temperature defined as <=36.5 degrees Celsius and high temperature defined as >=37.5 degrees Celsius."|Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
1371078|NCT01556425|Primary|Percent of Weekly Urine Samples Negative for Opiates|Was the participant’s urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates.|24 weeks||||percentage of negative urine samples||Full Range|Mean
1371056|NCT01556633|Secondary|Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit|ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond [msec]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as <=30, >30-60, and >60 msec increase from baseline.|From Baseline (Day -1) to Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
1371057|NCT01556633|Secondary|Number of Participants With Marked Abnormality in Laboratory Measurements|"Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase [ALT], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis.~Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L."|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
1371058|NCT01556633|Primary|Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate|CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t).|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine.|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||L/h||Geometric Coefficient of Variation|Geometric Mean
1371059|NCT01556633|Primary|Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate|"The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration.~The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||h||Full Range|Median
1371060|NCT01556633|Primary|C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration.~Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis.|||ng/mL||Standard Deviation|Mean
1371061|NCT01556633|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371062|NCT01556633|Primary|AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose|AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1371063|NCT01556633|Primary|AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||nanogram (ng)*h/ milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1371109|NCT01555931|Secondary|LNG-IUS Expulsion or Removal|Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study|up to 6 months||||participants|||Number
1371110|NCT01555931|Primary|Breastfeeding|Reported any breastfeeding at the final 6 month visit|6 months||||participants|||Number
1371064|NCT01556633|Secondary|Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
1371065|NCT01556633|Primary|Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose.~CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed[0-48])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC[0-48])~CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed[0-8]/AUC[0-8] + Aed[24-32]/AUC[24-32]) / 2~CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed[8-16]/AUC[8-16] + Aed[16-24]/AUC[16-24] + Aed[32-48]/AUC[32-48]) / 3"|CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood|Pharmacokinetic (PK) population: Only 9 participants were included for this analysis as they did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or if data was unavailable or incomplete which influence the PK analysis were excluded from the PK analysis population.|||Litre (L)/hour (h)||Geometric Coefficient of Variation|Geometric Mean
1371066|NCT01556594|Secondary|Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.|||hour*picogram per millilitre (hr*pg/mL)||Standard Deviation|Mean
1371067|NCT01556594|Secondary|Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.|||hours (hr)||Full Range|Median
1371068|NCT01556594|Secondary|Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
1371069|NCT01556594|Secondary|Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG).|||hours (hr)||Full Range|Median
1371070|NCT01556594|Secondary|Maximum Concentration (Cmax) of Baseline-Adjusted Glucose||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG).|||millimole per liter (mmol/L)||Standard Deviation|Mean
1371071|NCT01556594|Primary|Number of Participants With at Least One Adverse Event|Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Within 3 hours post glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG).|||Participants|||Count of Participants
1371072|NCT01556594|Primary|Percentage of Responders|Participants with a blood glucose increment of ≥1.5 millimole per liter [mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.|Pre-dose; 30 minutes following glucagon administration|All enrolled participants.|||percentage of participants|||Number
1371073|NCT01556451|Primary|Percentage of Participants Discontinued Due to Clinical Adverse Experiences||Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up|||Percentage of Participants|||Number
1371074|NCT01556451|Primary|Percentage of Participants With Clinical Adverse Experiences|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up|||Percentage of Participants|||Number
1371075|NCT01556451|Primary|Geometric Mean Titer (GMT) of VZV Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV|Day 1 (Baseline) and 4 weeks postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1371076|NCT01556451|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).|Day 1 (Baseline) and Week 4 postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures|||Ratio||95% Confidence Interval|Geometric Mean
1371111|NCT01555567|Secondary|Central Activation Ratio|CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force|Time of return to activity (~6 months following surgery)||||ratio||Standard Deviation|Mean
1371079|NCT01556347|Secondary|Percentage of Patients Who Receive Transplants Who Then Suffer Serious Post-transplant Complications|Percentage of study patients who receive transplants within the study period who then experience death, allograft loss, hospitalization due to infection, and non-fatal serious adverse cardiac event (defined as acute myocardial infarction, congestive heart failure, need for percutaneous cardiac intervention, coronary artery bypass grafting, cardiac defibrillator placement, cerebral vascular accident, peripheral vascular disease) within 1 year of transplantation.|730 days|No patients were transplanted within the study period so no patients could be analyzed for these potential outcomes||||||
1371080|NCT01556347|Secondary|Percentage of Patients With a CPRA <20%, But Were Not Transplanted During the Study Period|Proportion of patients who achieve a Calculated Panel Reactive Antibody test CPRA of < 20%, but are not transplanted within the study period.|583 days|No patients met this criteria since no patient had a CPRA of less than 20%.||||||
1371081|NCT01556347|Secondary|The Percentage of Allografts That Endure Acute Rejection Within One Year of Transplantation|The percentage of allografts that have an acute rejection episode per the criteria of the International Society of Heart and Lung Transplantation (ISHLT) within one year of transplantation. Allografts implanted during the Recovery Phase are monitored for a year for acute rejection per the study protocol. An allograft potentially implanted on the last day of a patient's recovery period would still be monitored for a year, so the potential outcome measure time would be 730 days. Since no allografts were implanted during the recovery period, there are no results to report.|730 days|No patients met the criteria for this group. The one patient who received a transplant did not have the transplant during the study period, and she did not have signs of rejection at the time of her autopsy.||||||
1371082|NCT01556347|Secondary|Percentage of Allograft Survival|The percentage of allografts transplanted during the study period that survive to 6 and 12 months post transplant.|730 days|No patients received a transplant during the study period. The one patient who was transplanted outside of the study period did not survive to 6 months.||||Allografts||
1371083|NCT01556347|Secondary|Percentage of Patients Post-Transplant That Are DSA Negative|Percentage of patients who receive a transplant within the study period who are then DSA negative at 1 year following transplantation.|730 days|No patients were in this group||||||
1371084|NCT01556347|Secondary|Percentage of Patients Who Develop De Novo Alloantibody or DSA Alloantibody After Transplant|Percentage of patients who are transplanted with the study period who then develop de novo or donor-specific alloantibody (DSA) within one year post-transplant. The patients would be eligible for transplant after day 218 in the study protocol and the study had 365 days in which to be transplanted. If a patient was transplant on day 583,( the last day of eligibility), and then followed for one year, then the outcome time frame would be a total of two years. No patient was transplanted within the study period.|730 days|No patients met the criteria for this measure since the one patient eventually transplanted did not live long enough to develop donor specific antibodies.||||||
1371085|NCT01556347|Secondary|The Percentage of Patients With Antibody Mediated Rejection After Transplantation|The percentage of patients who experience antibody mediated rejection at 6 months and 1 year post transplant. The study period was 583 days, during which a patient was eligible for transplant during the last 365 days. If a patient was transplanted on day 583, then the patient is followed for one year after the transplant, then the total time to assess the two patients would have been a period of two years or 730 days. In fact, neither patient was transplanted within the study period.|730 days|No study patient met the criteria for this measure since no patients were transplanted during the study period. The one patient who was eventually transplanted did not live to 6 months after the transplant.||||||
1371086|NCT01556347|Primary|Percentage of Patients With Grade 4 Hematologic Toxicities|A Grade 4 hematologic toxicity includes a platelet count < 25,000/mm3 or an absolute neutrophil count < 500/mm3|583 days|The two patient who entered the study were evaluated|||Participants|||Count of Participants
1371087|NCT01556347|Primary|The Percentage of Patients Who Experience Exacerbations Cardiac Dysrhythmias or Heart Failure|The percentage of study patients who experience an exacerbation of cardiac dysrhythmias and heart failure during the study period|583 days|The two patients entered into the study were evaluated.|||Participants|||Count of Participants
1371088|NCT01556347|Primary|The Percentage of Patients Who Experience Either a Respiratory Tract Infection or a Urinary Tract Infection|The percentage of study patients who experience infectious complications in either the respiratory or urinary tracts during the study period.|583 days|The two patients who entered the study were evaluated|||Participants|||Count of Participants
1371089|NCT01556347|Primary|Percentage of Patients Who Experience CMV, PTLD, and PML|Percentage of patients who experience cytomegalovirus (CMV), post-transplant lymphoproliferative disease (PTLD), or progressive multifocal leukoencephalopathy (PML) during the study period.|583 days|The two patients who entered the study were evaluated.|||Participants|||Count of Participants
1371090|NCT01556347|Primary|The Percentage of Patients Who Experience Any Grade of Peripheral Neuropathy|The percentage of patients in the study who experience any grade of peripheral neuropathy during the study period|583 days|The two patients entered into the study were analyzed.|||Participants|||Count of Participants
1371091|NCT01556347|Primary|Percentage of Patients Who Experience Grade 3 and Above Non-Hematologic Toxicities|Percentage of patients who experience of grade 3 and above non-hematologic toxicities as measured by the incidence of hypersensitivity reaction, fever, nausea and vomiting or dehydration during the study period.|583 days|There were two patients entered into the study and both were analyzed.|||Participants|||Count of Participants
1371092|NCT01556347|Primary|Percentage of Patients Who Suffer Mortality, a Serious Adverse Event, or Other Adverse Event During the Study Period|Percentage of study patients who experience a serious safety issue during the three phases of the study as measured by all cause mortality, serious adverse reactions and other adverse reactions.|583 days|Two patients were entered into the study and both were analyzed|||Participants|||Count of Participants
1371093|NCT01556347|Primary|Percentage of Patients Transplanted|Percentage of patients, who are transplanted within one year of finishing the Bortezomib treatment phase.|365 days|The two patients who were entered into the study were analyzed.|||Participants|||Count of Participants
1371112|NCT01555567|Primary|Quadriceps Strength||Time of return to activity (~6 months following surgery)||||Nm/kg||Standard Deviation|Mean
1371094|NCT01556347|Primary|Percentage of Patients With a Reduction in CPRA to Less Than 20%|Percentage of highly sensitized heart transplant candidates, (patients with a CPRA greater than 50%), who have desensitization therapy, and then achieve a reduction in alloantibody such that their CPRA falls below 20%. For an individual patient, the outcome measure time frame is the one year of the Recovery Phase which begins after 218 days from the time that the patient begins the Induction Immunotherapy Phase, which is the same as the end of the Bortezomib Treatment Phase.|365 days|There were two patients entered into the study and therefore two patients analyzed.|||Participants|||Count of Participants
1371095|NCT01556204|Secondary|Pain|Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.|Baseline, 6-weeks, 6-months||||units on a scale||Standard Deviation|Mean
1371096|NCT01556204|Primary|Operative Time|Operative time is defined as skin incision to skin closure.|1st 24 hours||||minutes||Standard Deviation|Mean
1371097|NCT01556165|Secondary|Levodopa Administration Within 26 Weeks|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26|||||||
1371098|NCT01556165|Secondary|Time to Onset of Levodopa Therapy|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26|||||||
1371099|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
1371100|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
1371101|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
1371102|NCT01556165|Primary|Change From Baseline to Week 26 in UPDRS Total Score|The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson’s disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
1371103|NCT01556100|Secondary|To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients.|"The test/retest reliability will be estimated from a subgroup of the study subjects (10 subjects) who receive additional scan within 4 weeks since baseline image.~In order to refine the definition of a positive 18F-DTBZ in patient with PD as compared to healthy control, quantitative measurement will be used. The standard uptake value (SUV) of each brain regions will be calculated. The SUV is a widely used, simple PET quantifier, calculated as a ratio of tissue radioactivity concentration (e.g. in units kBq/ml) at time t, CPET(t) and injected dose (e.g. in units MBq) at the time of injection divided by body weight (e.g. in units kg).SUV = CPET(t) / (Injected dose / Patient's weight), t =90min, and the unit of SUV is g/ml."|three years|A subgroup of 10 subjects receive additional scan for a test/retest reliability study|||g/mL||80% Confidence Interval|Mean
1371104|NCT01556100|Primary|Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36|To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD.|three years||||SUVR||80% Confidence Interval|Mean
1371105|NCT01556061|Secondary|Second Laryngoscopy|A second laryngoscopy will be performed in patients with the video laryngoscope from the other group. Patients will be intubated after second laryngoscopy with with this same video laryngoscope.|30 seconds||||seconds||Inter-Quartile Range|Median
1371106|NCT01556061|Secondary|First Laryngoscopy|Patients underwent laryngoscopy first with their assigned randomized laryngoscope. Time measured was from the time from the moment the anesthesiologist had the laryngoscope in hand to time to optimal visualization of vocal cords.|30 seconds||||seconds||Inter-Quartile Range|Median
1371107|NCT01556061|Primary|Time for Intubation|Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.|90 seconds|The unit of measure of time in seconds from D-MAC larynogoscopy to intubation in the (C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy) group and from C-MAC laryngoscopy to intubation in the (D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy) group.|||seconds||Inter-Quartile Range|Median
1371108|NCT01555983|Primary|Number of Participants Achieving a Reduction in Pain Intensity of 30% or More|Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.|hourly pain assessments for 8 hours||||participants|||Number
1371113|NCT01555489|Secondary|Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument|1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.|15 weeks|The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.||||||
1371114|NCT01555489|Primary|Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer|Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants.|15 weeks|The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.||||||
1371115|NCT01555463|Secondary|Change From Baseline in Index Value at End of Treatment|The EuroQol Group Questionnaire–5 Dimensions–5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: “no problems” (level 1), “slight problems” (level 2), “moderate problems” (level 3), “severe problems” (level 4), and “extreme problems” (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Scores on a scale||Full Range|Median
1371116|NCT01555463|Secondary|Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment|"The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented."|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Scores on a scale||Full Range|Median
1371117|NCT01555463|Secondary|Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score|The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant’s skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: “very much” (question 7: “yes”) (score=3), “a lot” (score=2), “a little” (score=1), or “not at all”/”not relevant” (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment – baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
1371118|NCT01555463|Secondary|Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score|The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant’s quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are “never” (score=1), “rarely” (score=2), “sometimes” (score=3), “often” (score=4), or “all the time” (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented.|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Scores on a scale||Standard Deviation|Mean
1371119|NCT01555463|Secondary|Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment|At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
1371120|NCT01555463|Secondary|Participants' Opinion on Cosmetic Acceptability at End of Treatment|At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
1371121|NCT01555463|Secondary|Participants' Global Assessment of Tolerability at End of Treatment|At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
1371122|NCT01555463|Secondary|Participants' Global Assessment of Treatment Response at End of Treatment|At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
1371123|NCT01555463|Secondary|Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)|Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
1371124|NCT01555463|Secondary|Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)|Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an ‘improved’ telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, ‘no change’ if the rating was identical, and ‘worsened’ if the rating was higher. The percentage of participants in each category is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
1371125|NCT01555463|Secondary|Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)|The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
1371126|NCT01555463|Secondary|Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) lesion count at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Inflammatory lesions||Standard Deviation|Mean
1371127|NCT01555463|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Scores at End of Treatment (LOCF)|The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
1371128|NCT01555463|Secondary|Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)|Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into ‘improved’, ‘no change’, or ‘worsened’. A participant was considered to have an ‘improved’ erythema rating if the erythema rating was lower compared to the baseline rating, ‘no change’ if the rating was identical, and ‘worsened’ if the rating was higher. The percentage of participants in each of these categories is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
1371129|NCT01555463|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)|Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as ‘responder’. Participants with an IGA of moderate or severe at the end of treatment were considered as ‘non-responder’. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as ‘non-responders’. The percentage of responders is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
1371130|NCT01555463|Secondary|Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percent change of inflammatory lesions||Standard Deviation|Mean
1371131|NCT01555463|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)|The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Inflammatory lesions||Standard Deviation|Mean
1371143|NCT01555151|Secondary|Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters per second||Standard Error|Least Squares Mean
1371132|NCT01555463|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
1371133|NCT01555164|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations; analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1371134|NCT01555164|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1371135|NCT01555164|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations, and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.|||percent of HbA1c in blood||Standard Deviation|Mean
1371136|NCT01555151|Secondary|Plasma Cortisol Concentrations|Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L|Baseline, days 1 and 28|The safety set includes all subjects who received at least one dose of study drug.|||nmol/L||Standard Deviation|Mean
1371137|NCT01555151|Secondary|Fractional Exhaled Nitric Oxide (FeNO)|FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.|Days 15 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||ppm||Standard Error|Mean
1371138|NCT01555151|Secondary|Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment|"Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.~A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.~The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use."|4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||percentage days||Standard Error|Least Squares Mean
1371139|NCT01555151|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment|Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Baseline and 4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||number of puffs||Standard Error|Least Squares Mean
1371140|NCT01555151|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).|Baseline, days 8,15,22 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Units on a scale||Standard Error|Least Squares Mean
1371141|NCT01555151|Secondary|Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment|Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.|Baseline and week 4|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters per min||Standard Error|Least Squares Mean
1371142|NCT01555151|Secondary|Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Percent||Standard Error|Least Squares Mean
1371144|NCT01555151|Secondary|Forced Vital Capacity (FVC) at All Time Points|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters||Standard Error|Least Squares Mean
1371145|NCT01555151|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 8, 15 and 22|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters||Standard Error|Least Squares Mean
1371146|NCT01555151|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.|Day 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters||Standard Error|Least Squares Mean
1371147|NCT01555138|Secondary|St Georges Respiratory Questionnaire for COPD|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|12 and 26 weeks|Full Analysis set|||scores on a scale||Standard Error|Least Squares Mean
1371148|NCT01555138|Secondary|Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'|A ‘day with no rescue use’ is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of ‘days with no rescue use’ will be derived and analyzed as for the percentage of ‘nights with no nighttime awakenings’.|26 weeks|Full Analysis Set|||% of Days||Standard Error|Least Squares Mean
1371149|NCT01555138|Secondary|Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment|The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.|12 and 26 weeks||||number of puffs||Standard Deviation|Mean
1371150|NCT01555138|Secondary|Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)|The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks||||participants|||Number
1371151|NCT01555138|Secondary|TDI Focal Score at Week 12 and Week 26: Treatment Comparisons|The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.|12 and 26 weeks||||Units on a scale||Standard Error|Least Squares Mean
1371152|NCT01555138|Secondary|Analysis of AUC (5 Min – 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison|The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.|12 and 26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
1371153|NCT01555138|Secondary|FVC Over 26 Weeks of Treatment|FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 and 26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
1371154|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .|26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
1371155|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
1371156|NCT01555138|Secondary|Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons|Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.|26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
1371196|NCT01554891|Primary|Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.|Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2) Cohort 2: The primary endpoint for this sub-study is the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen. (Speciﬁc Aim 2).|baseline|Analyses done for Cohort 2 only.|||percentage of participants||95% Confidence Interval|Number
1371157|NCT01555138|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons|Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.|12 weeks|full analysis set|||Liters||Standard Error|Least Squares Mean
1371158|NCT01555125|Secondary|Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity|The development of anti-secunimubab anti-bodies will decrease a participant’s ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment|Baseline and at Week 12, 24, 52, 100, 148, and 196, 204||||Number of participants|||Number
1371159|NCT01555125|Secondary|Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant’s disease state at the time of the assessments and does not attempt a comparison to any of the participant’s previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe|Week 172|Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.|||Number of participants|||Number
1371160|NCT01555125|Secondary|Absolute Change From Baseline for PASI Score After Week 52, (Observed Data)|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Week 172|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1371161|NCT01555125|Secondary|Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.|Week 172|Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.|||Number of participants|||Number
1371162|NCT01555125|Secondary|Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
1371163|NCT01555125|Secondary|Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
1371164|NCT01555125|Secondary|Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference)."|Baseline and week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent change||95% Confidence Interval|Median
1371165|NCT01555125|Secondary|Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference)."|Baseline and week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent change||95% Confidence Interval|Median
1371239|NCT01553851|Primary|Number of Participants With Changes in TumorCell Surface CD44 Expression After Treatment With GSK1120212.|Pre-post measure of CD44 expression using IHC.|Baseline and Day 15||||Participants|||Number
1371166|NCT01555125|Secondary|Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1371167|NCT01555125|Secondary|Change From Baseline in EQ-5D at Week 12 (Induction)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1371168|NCT01555125|Secondary|Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)|The IGA mod 2011 category scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
1371169|NCT01555125|Secondary|Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)|The IGA mod 2011 category scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Number of participants|||Number
1371170|NCT01555125|Secondary|Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data)|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1371171|NCT01555125|Secondary|Absolute Change From Baseline for PASI Score at Week 12, (Induction)|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1371172|NCT01555125|Secondary|Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data)|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
1371173|NCT01555125|Secondary|Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
1371174|NCT01555125|Secondary|Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
1371175|NCT01555125|Secondary|Percentage of Subjects With Successful Self Administration of Study Drug at Week 1|To assess the subject’s ability to follow instructions for use with the secukinumab PFS|Week 1|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received|||Percentage of participants|||Number
1371176|NCT01555125|Secondary|Number of Subjects With Potential Use Related Hazards at Week 1|To assess potential use-related hazards with the secukinumab PFS for the subject|Week 1|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received|||Number of participants|||Number
1371177|NCT01555125|Secondary|Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48|The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Baseline, week 48|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.|||Score||Standard Deviation|Mean
1371178|NCT01555125|Secondary|Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12|The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 12|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received|||Score||Standard Deviation|Mean
1371179|NCT01555125|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator’s Global Assessment) With a 0 or 1 Response at Week 12|The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe|12 weeks|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of Participants|||Number
1371180|NCT01555125|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 weeks|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
1371181|NCT01555073|Secondary|Quality of Life|To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months||||||
1371182|NCT01555073|Primary|Post Operative Pain Control|To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months||||||
1371183|NCT01554982|Other Pre-specified|IV Iron Use|Percent of subjects with No IV iron intake from first dose of study drug to Week 48|48 weeks||||percentage of participants|||Number
1371184|NCT01554982|Other Pre-specified|Hemoglobin- Week 48||48 weeks||||g/dL||Standard Deviation|Mean
1371185|NCT01554982|Other Pre-specified|Hemoglobin- Baseline||Baseline||||g/dL||Standard Deviation|Mean
1371186|NCT01554982|Other Pre-specified|TSAT- Week 48||48 weeks||||percentage of saturation||Standard Deviation|Mean
1371187|NCT01554982|Other Pre-specified|Transferrin Saturation (TSAT) - Baseline||Baseline||||percentage of saturation||Standard Deviation|Mean
1371188|NCT01554982|Other Pre-specified|Ferritin- Week 48||48 weeks||||ng/mL||Standard Deviation|Mean
1371189|NCT01554982|Other Pre-specified|Ferritin- Baseline||Baseline||||ng/mL||Standard Deviation|Mean
1371190|NCT01554982|Other Pre-specified|Serum Phosphorus- Week 48||48 weeks||||mg/dL||Standard Deviation|Mean
1371191|NCT01554982|Other Pre-specified|Serum Phosphorus- Baseline||Baseline||||mg/dL||Standard Deviation|Mean
1371192|NCT01554982|Primary|Safety Parameters|Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).|48 Weeks|Safety Population; Treatment Emergent Adverse Events (TEAEs), not including SAEs, reported include only those occurring at a frequency >5%|||participants|||Number
1371193|NCT01554904|Secondary|Apnea-Hypopnea Index (AHI)|The number of apneas and hypopneas per hour of monitoring|baseline and after 6 weeks of facial muscle training|Participants completing 6 weeks of training and second sleep study|||events per hour||Standard Deviation|Mean
1371194|NCT01554904|Primary|Snore Index|The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device [Sleep Scout (ClevMed, Cleveland Ohio)] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).|baseline and after 6 weeks of facial muscle training|Subjects completing 6 weeks of training and Home Sleep Test # 2|||snores per hour of monitoring||Standard Deviation|Mean
1371195|NCT01554891|Primary|Sensitivity and Specificity of the SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI|6-months after medical evacuation|Data were only collected for cohort 3.|||percentage|||Number
1371258|NCT01553539|Secondary|Overall Survival||Approximately 5 years||||months||95% Confidence Interval|Median
1371259|NCT01553539|Secondary|Time to Disease Progression||Approximately 5 years||||months||95% Confidence Interval|Median
1371197|NCT01554891|Primary|Test-retest Reliability SAFE-TBI|Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1) Cohort 1: The primary endpoints for this sub-study (cohort) are the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks) as well as the two rater types TRC vs. TBIC. (Speciﬁc Aim 1).|Up to 6 weeks|Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview.|||kappa (reliability)||95% Confidence Interval|Number
1371198|NCT01554579|Secondary|SF-36|The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.|4 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.|||units on a scale||Standard Deviation|Mean
1371199|NCT01554579|Secondary|WOMAC Scores|This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system [IVRS]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.|4 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.|||units on a scale||Standard Deviation|Mean
1371200|NCT01554579|Primary|The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)|Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system [IVRS]) every evening before bedtime.|2 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.|||units on a scale||Full Range|Mean
1371201|NCT01554241|Secondary|Free 25-OH Vitamin D3|circulating free 25-OH vitamin D3 concentration|16 weeks||||pg/mL||Standard Deviation|Mean
1371202|NCT01554241|Primary|Total 25-OH Vitamin D3 Level|circulating total 25-OH vitamin D concentration|16 weeks||||ng/mL||Standard Deviation|Mean
1371203|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.|From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
1371204|NCT01554176|Primary|Number of Participants With an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.|From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
1371205|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
1371206|NCT01554176|Primary|Number of Participants With an Adverse Event (AE) During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
1371260|NCT01553539|Primary|Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|See the adverse event tables for specifics.|Approximately 1 year||||Participants experiencing adverse events|||Number
1371207|NCT01554176|Secondary|Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 54. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. A participant with HAM-D17 total score ≤7 at Week 6 of the Treatment Phase was defined to have achieved HAM-D17 remission.|Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 score.|||percentage of participants|||Number
1371208|NCT01554176|Secondary|Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). The Bech subscale of the HAM-D17 is composed of 6 identified items out of the 17 items rated. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). Total score ranged from 0 to 22, with a higher score indicating greater symptom severity. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). The reported measure is the change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 Beck Subscale score.|||score on a scale||Standard Deviation|Mean
1371209|NCT01554176|Secondary|Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item|"The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. This measure considered 9 of the 10 MADRS items: apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. It excluded reduced sleep. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values."|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 MADRS score.|||score on a scale||Standard Deviation|Mean
1371210|NCT01554176|Primary|Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 value.|||score on a scale||Standard Deviation|Mean
1371211|NCT01554163|Secondary|Time-Weighted Mean Response on the Investigator Global Assessment of Response to Therapy|Study investigators were asked to rate the global assessment of participant response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a value at Week 6 and Week 12 for the Investigator Global Assessment of Response to Therapy.|||Score on a Scale||Standard Error|Least Squares Mean
1371212|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Stiffness Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The stiffness subscale rates stiffness after first waking and later in the day using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of stiffness and 100 is the highest level of stiffness. The stiffness subscale is calculated as the average of the responses to the 2 questions related to stiffness. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all paricipants that received one dose of study medication and had a baseline value for the WOMAC stiffness subscale, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
1371213|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Investigator Global Assessment of Disease Status|Study investigators were asked to rate the global assessment of participant disease status on a Likert scale from 0 to 4, with 0 = very well, 1 = good, 2 = fair, 3 = poor and 4 = very poor. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Investigator Global Assessment of Disease Status, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
1371214|NCT01554163|Secondary|Time-Weighted Mean Response in the Participant Global Assessment of Response to Therapy|Participants were asked to rate their global assessment of response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a Week 2, Week 6, and Week 12 value for the Participant Global Assessment of Response to Therapy.|||Score on a Scale||Standard Error|Least Squares Mean
1371215|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Participant Global Assessment of Disease Status|The Participant Global Assessmet of Disease was a one item questionnaire that asked participants to answer the following question, “Considering all the ways your arthritis affects you, mark (X) on the scale for how well you are doing.” The questionnaire employed a 0-100 mm visual analog scale (VAS) to record participant responses, with 0 representing the best possible assessment and 100 representing the worst possible assessment. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Participant Global Assessment of Disease Status, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
1371216|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of functioning and 100 is the highest level of functioning. The physical function subscale was calculated as the average of the responses to the 17 questions related to functional status. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC physical function subscale, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
1371217|NCT01554163|Primary|Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC pain subscale, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
1371218|NCT01553916|Secondary|Rate of Overall Survival|-Overall survival is defined as the time between date of on study and date of death due to any cause|12 months|7 participants were not evaluable for this outcome measure|||Participants|||Count of Participants
1371219|NCT01553916|Secondary|Number of Central Nervous System (CNS) Adverse Events|Adverse events will be tabulated by type and grade using NCI CTCAE v 4.|Through 12 months||||CNS adverse events|||Number
1371220|NCT01553916|Secondary|Number of Participants With Brain Metastases|1-year rate of brain metastases|12 months|7 participants were not evaluable for this outcome measure|||Participants|||Count of Participants
1371221|NCT01553916|Secondary|Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume||Baseline through 12 months|"10 participants were evaluable for this outcome measure~Originally the outcome measure time frame was baseline through 12 months but there was insufficient data to statistically analyze the change in hippocampal morphology at 12 months due to the number of participants still alive for the 12 month scan."|||cc||Full Range|Median
1371222|NCT01553916|Secondary|Feasibility of Performing Serial Neurocognitive Testing and Quality of Life Exams as Measured by Number of Patients Who Complete the Neurocognitive Testing and Quality of Life Exams|-Defined as at least 4 of 6 patients successfully completing pre-treatment and 3 month post-treatment testing|3 months|(1) participant is not evaluable as the participant did not start treatment due to pre-treatment MRI showing metastatic disease in spine.|||Participants|||Count of Participants
1371223|NCT01553916|Secondary|Changes in Quality-of-life as Measured by Overall Quality of Life Using the Total Score of the EORTC QLQ-BN20|"Assessed by comparing questionnaire test scores to baseline; BN20 (future uncertainty and communications deficit scales)~20 questions with answers ranging from 1-4 with 1=not at all and 4=very much~Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score)~The higher the score the lower quality of life"|12 months|5 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
1371224|NCT01553916|Secondary|Changes in Quality-of-life as Measured by Overall Quality of Life Using the EORTC QLQ30|"Assessed by comparing questionnaire test scores to baseline; European Organization for Research and Treatment of Cancer (EORTC) QLQ30 (global health/QOL, cognitive functioning, and fatigue scales)~30 total questions with 28 questions having answers ranging from 1-4 with 1=not at all and 4= very much and 2 questions ranging from 0-7 with 1-very poor and 7=excellent~Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score)~The higher the score the lower the quality of life"|3 months|5 participants were not analyzed for this outcome measure|||scores on a scale||Standard Deviation|Mean
1371225|NCT01553916|Secondary|Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.~The words recalled were recorded and a total recall score tallied (range: 0–36).~The higher the score the better the recall"|12 months|13 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
1385388|NCT01402817|Secondary|Volumetric Disease Evaluation|To determine the response rate with Sutent® in patients with plexiform neurofibromas using volumetric analysis of MRI scans|6 months||||percentage of subjects|||Number
1371226|NCT01553916|Secondary|Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.~The words recalled were recorded and a total recall score tallied (range: 0–36).~The higher the score the better the recall"|6 months|11 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
1371227|NCT01553916|Secondary|Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.~The words recalled were recorded and a total recall score tallied (range: 0–36).~The higher the score the better the recall"|3 months|-8 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
1371228|NCT01553916|Secondary|Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.~The words recalled for each trial were recorded and a total recall score tallied (range: 0–36).~The higher the score the better the recall"|12 months|13 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
1371229|NCT01553916|Secondary|Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.~The words recalled for each trial were recorded and a total recall score tallied (range: 0–36).~The higher the score the better the recall"|6 months|11 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
1371230|NCT01553916|Primary|Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.~The words recalled for each trial were recorded and a total recall score tallied (range: 0–36).~The higher the score the better the recall"|3 months|6 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
1371231|NCT01553916|Primary|Safety of Lithium Carbonate as Measured by Number of Patients in the Safety lead-in Who Experienced a Dose-limiting Toxicity (DLT)|-Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as < 2 patients experiencing DLTs of the first 6 treated.|3 weeks|-Only patients enrolled in the safety lead-in were evaluable for this outcome measure|||Participants|||Count of Participants
1371232|NCT01553851|Secondary|Percent of Participants With Metabolic Changes in OCSCC Using FDG-PET/CT Imaging.|Intratumarol metabolic changes were evaluated by changes in in SUVmax in the primary tumor; quantitative analysis SUVmax with the primary tumor site was determined within a volume of interest around the tumor using a Siemens eSoft workstation.|Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)|||percentage of participants|||Number
1371233|NCT01553851|Secondary|Percent Change in Tumor Size Area||Baseline and Day 15|Quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.|||percent change in tumor size area||Full Range|Median
1371234|NCT01553851|Secondary|Safety of GSK1120212|Number of adverse events were monitored for 30 day following last dose of GSK1120212|1st 4-6 week follow-up visit||||Adverse events|||Number
1371235|NCT01553851|Secondary|Percent Change in Maximum Standard Uptake Value in Oral Cavity Saqumous Cell Carcinoma (OCSCC) Using F18-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT).||Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)|||percentage change in SUVmax||Full Range|Median
1371236|NCT01553851|Secondary|Flow Cytometric Analysis of the Peripheral Blood and Tumor.|"Peripheral blood - baseline and Day 14~Tumor - baseline and Day 15"|Baseline, Day 14, and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.||||||
1371237|NCT01553851|Secondary|Percentage of Participants With Clinical Response Induced by GSK1120212, as Determined by Change in Tumor Size.|Clinical Response was evaluted by quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.|Baseline and Day 15||||percentage of participants|||Number
1371238|NCT01553851|Secondary|Tumor Specific Findings for Pathologic Changes Including Proliferation (Ki-67 Staining), Tumor Vasculature Staining (Microvessel Density), ERK1/2 Mediated Changes in p27 (Kip1) & Flow Cytometric Analysis of the Peripheral Blood & Tumor.||Baseline and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.||||||
1371240|NCT01553851|Primary|Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.|Pre-post measure of p-EKP expression was measured by change in staining intensity and quartile distribution.|Baseline and Day 15|Only15 of the 17 participants had sufficient pre- and post-treatment biopsies with sufficient tumor content to be evaluated for this biomarker assessment.|||participants|||Number
1371241|NCT01553747|Secondary|Change From Baseline in IBS-QoL Total Scores|The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.|Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
1371242|NCT01553747|Secondary|Number of Urgency Episodes Per Day|Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||episodes per day||Standard Deviation|Mean
1371243|NCT01553747|Secondary|Number of Bowel Incontinence Free Days|An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||days||Standard Deviation|Mean
1371244|NCT01553747|Secondary|Number of Bowel Incontinence Episodes|Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||incontinence episodes||Standard Deviation|Mean
1371245|NCT01553747|Secondary|Number of Bowel Movements Per Day|Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||bowel movements per day||Standard Deviation|Mean
1371246|NCT01553747|Secondary|Change From Baseline in Daily Abdominal Bloating Scores|Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.|Baseline, Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
1371247|NCT01553747|Secondary|Change From Baseline in Daily Abdominal Discomfort Scores|Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.|Baseline, Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
1371248|NCT01553747|Secondary|Percentage of Participants With Irritable Bowel Syndrome – Adequate Relief (IBS-AR) Scale|Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of “Yes” to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder.|12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
1371249|NCT01553747|Secondary|Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale|IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.|Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
1371261|NCT01553539|Primary|Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response|'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Approximately 1 year||||participants|||Number
1371262|NCT01553318|Secondary|Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10|Change in peripheral blood levels of IL-8, MCP-1 and Eotaxin from baseline to week 10|baseline and week10|We do not have data on the chemokines because of the problems we had with the assays. Indeed, IL-8, MCP-1 and Eotaxin were all secondary outcomes.||||||
1371250|NCT01553747|Secondary|Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals|IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5-point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
1371251|NCT01553747|Secondary|Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals|Stool consistency responders: Participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
1371252|NCT01553747|Secondary|Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals|Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
1371253|NCT01553747|Secondary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores|Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.|Up to 26 weeks|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
1371254|NCT01553747|Primary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores|Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.|Up to 12 weeks|Intention-to-treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
1371255|NCT01553708|Secondary|Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.|"Pain and itching assessment is evaluated by patients themselves in every time of wound observations using Visual Analog Scale.~% Wound contraction.~Time and type of analgesic or itching medication after treatment.~Laboratory measurement such as CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes or any systemic effect after treatment.~Adverse reaction such as swelling, edema and redness at wound site."|On 28th day after admission|||||||
1371256|NCT01553708|Primary|Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).|Time (days)for complete epithelialization (no open wound exists as determined by 2 surgeons) is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.|On 28th day after admission||||Days||Standard Deviation|Mean
1371257|NCT01553539|Secondary|Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)||Baseline and Day 22||||pg/mL||Standard Deviation|Median
1371264|NCT01553318|Secondary|Change From Baseline in Evoked Pain Score at Week 10|Change in evoked pain score from baseline to week 10 (scale range -20 to +20): interpretation= the more negative the value is, the larger the reduction in sensitivity to pressure pain stimuli|baseline and week 10||||units on a scale||Standard Deviation|Mean
1371265|NCT01553318|Primary|Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10|Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is|baseline and week 10||||units on a scale||Standard Deviation|Mean
1371266|NCT01553292|Secondary|Needs for Intubation During the Procedure|The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)|10 minutes|The number of preterm infants that needed intubation by ETT (endotracheal intubation) during ECALMIST|||Number of participants|||Number
1371267|NCT01553292|Secondary|Oxygen Requirements After the Procedure|Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100. The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.|4 hours|The mean of oxygen level (proportion) of all participant after ECALMIST|||Proportion of oxygen saturation||Standard Deviation|Mean
1371268|NCT01553292|Secondary|Oxygen Saturation Before the Procedure|Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of saturation of all participants before ECALMIST|||Proportion of oxygen saturation||Standard Deviation|Mean
1371269|NCT01553292|Secondary|CPAP Pressure Before the Proceudre|Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)|1 hour|The mean of CPAP pressure that is measured by centimeter of water of all the participant before ECALMIST|||Centimeter of water||Standard Deviation|Mean
1371270|NCT01553292|Secondary|Index After the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.~FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|4 hours|The mean of ECALMIST index of all the participants after ECALMIST|||Score||Standard Deviation|Mean
1371271|NCT01553292|Secondary|Oxygen Saturation After the Procedure|Oxygen saturation is measured by pulse oximetry. It is express as proportion out of 1 (decimal) that is equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|4 hours|The mean of oxygen saturation after ECALMIST for all the participants|||Proportion of oxygen saturation||Standard Deviation|Mean
1371272|NCT01553292|Secondary|Oxygen Requirement Before the Procedure|Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of oxygen requirement of all the participants before ECALMIST|||Proportion of oxygen requirement||Standard Deviation|Mean
1371273|NCT01553292|Secondary|CPAP Pressure After the Procedure|Continuous positive airway pressure (CPAP) is measured in centimeter of water|4 hours|The mean of CPAP pressure express as centimeter of water of all participants after completion of ECALMIST|||Centimeter of water||Standard Deviation|Mean
1371274|NCT01553292|Secondary|Index Before the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.~FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|1 hour|The mean of index of all participants before ECALMIST|||Score||Standard Deviation|Mean
1371275|NCT01553292|Primary|Incidence of Early Ventilation Hours|The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing|72 hours|The number of preterm infants that need intubation by ETT within 72 hours of life(early ventilation). This is includes all infants intubated whether during or after the ECALMIST procedure in the 1st 3 days of life (after delivery)|||Number of participants|||Number
1371276|NCT01553292|Secondary|Failure to Catheterized the Trachea by the Vascular Catheter|Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.|20 seconds|Number of infatns that failed to pass the angiocath to the trachea after 2 trials, 20 seconds each trial.|||Number of participants|||Number
1371277|NCT01553292|Secondary|Saturation During the Procedure|Level of oxygen which is measured by oxygen pulse Oximetry. It is express as proportion out of one which is equal to percentage of 100. The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.|10 minutes|The mean of oxygen saturation of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)|||Proportion of oxygen saturation||Standard Deviation|Mean
1371278|NCT01553292|Secondary|Incidence of Bradycardia During Procedure|Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.|Range of 10 minutes|The mean of heart beat per minute of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)|||Number of participants|||Number
1371279|NCT01553240|Secondary|Vineland Maladaptive Behavior Scale||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1371280|NCT01553240|Primary|Repetitive Behavior Scale-revised||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
1371509|NCT01550549|Post-Hoc|Inter-reader Reliability|Measure of agreement among multiple readers using binary read method (Fleiss' kappa). Where available, histopathology analysis at autopsy was the truth standard (TS).|Scan acquired 50-60 min post-injection|59 from study A07(NCT00857415)/A16(NCT01447719) and 92 from study A05(NCT00702143)|||kappa statistic||95% Confidence Interval|Number
1371281|NCT01553136|Secondary|Drinking Related Consequences|A self-report measure of negative consequences from drinking will be administered and the total score are analyzed. The ImBIBe, a measure of alcohol consequences based on the Drinker Inventory of Consequences (DRINC) was used. The DRINC total score has a range from 0-45, 45 being the highest score (or greatest number of negative consequences).|End of treatment (Week 17)||||units on a scale||Standard Error|Least Squares Mean
1371282|NCT01553136|Secondary|Smoking Abstinence|Smoking abstinence is defined by self-reported abstinence from smoking for the last four weeks of treatment (weeks 13-16) and a urine cotinine level less than 15ng/mL measured at week 17.|Weeks 13-16||||Participants|||Count of Participants
1371283|NCT01553136|Primary|Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment|The percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally).|8 weeks||||percentage of heavy drinking days||Standard Error|Least Squares Mean
1371284|NCT01553136|Primary|Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment|The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.|weeks 13-16||||log transformed percentage of days||Standard Error|Mean
1371285|NCT01553136|Primary|Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment|The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.|weeks 9-12||||log transformed percentage of days||Standard Error|Mean
1371286|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: GlycA|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
1371287|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Interleukin 6|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log interleukin 6.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
1371288|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log Tumor necrosis factor-alpha.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
1371289|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log C-reactive Protein|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log C-reactive protein (CRP).|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
1371290|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Leptin|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
1371291|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Adiponectin|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.|Baseline - Week 12||||log(ug/mL)||Standard Deviation|Mean
1371292|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Insulin|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
1371293|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on high density lipoprotein particle total.|Baseline - Week 12||||umol/L||Standard Deviation|Mean
1371294|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on low density lipoprotein particle total.|Baseline - Week 12||||nmol/L||Standard Deviation|Mean
1371295|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Cholesterol Efflux|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on cholesterol efflux capacity. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]. The pooled plasma was obtained from five healthy volunteers.|Baseline - Week 12||||unitless||Standard Deviation|Mean
1371296|NCT01553058|Secondary|Number of Patients With Adverse Events.|Safety will be assessed by comparing how many patients have adverse events depending on whether they are on adalimumab, as compared to NB-UVB phototherapy or placebo.|Baseline - Week 12||||Participants|||Count of Participants
1371297|NCT01553058|Secondary|Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)|Patient reported physical activity will be assessed using IPAQ. IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.|Baseline week 4, 8 and 12||||MET-minutes/week||Standard Deviation|Mean
1371325|NCT01552915|Secondary|Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.|||percentage of participants|||Number
1371298|NCT01553058|Secondary|Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)|Patient reported dietary outcomes will be assessed using MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument for properly assessing cardiovascular diet. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).|Baseline to Week 12||||units on a scale||Standard Deviation|Mean
1371299|NCT01553058|Secondary|Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)|Patient reported quality of life outcomes will be assessed using DLQI. The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline - Week 12||||units on a scale||Standard Deviation|Mean
1371300|NCT01553058|Secondary|Change in Patient-reported Outcomes-EuroQol EQ-5D|EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient’s self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.|Baseline -Week 12||||units on a scale||Standard Deviation|Mean
1371301|NCT01553058|Secondary|Change in Psoriasis Activity (PASI-75 and PGA)|Psoriasis activity will be assessed using standard psoriasis measurements, PASI75 and PGA Clear/Almost Clear|Baseline - Week 12||||Participants|||Count of Participants
1371302|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Total Cholesterol|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.|Baseline - Week 12||||mg/dL||Standard Deviation|Mean
1371303|NCT01553058|Primary|Change in Vascular Inflammation|Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12. The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).|Baseline - Week 12||||Tissue-to-background ratio (TBR)||Standard Deviation|Mean
1371304|NCT01552954|Secondary|Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16|Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16 in the Intensive Education Group compared to the Conventional Education Group|week 8 and week 16||||mm Hg||Standard Deviation|Mean
1371305|NCT01552954|Secondary|Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16|Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet at week 16|week 8 and week 16||||mEq/day||Standard Deviation|Mean
1371306|NCT01552954|Secondary|∆Hemoglobin (0 Week - 16 Weeks)|The change of hemoglobin after prescription of Olmesartan|0 week, 16 weeks||||g/dL||Standard Deviation|Mean
1371307|NCT01552954|Primary|∆Albuminuria by 24-hour Urine Protein Excretion|"Change in albuminuria as a 24-hour urine protein excretion by intensive education of low salt diet during taking olmesartan~*In outcome measure data table, the 24-hour urine collection at 16th week was omitted in 3 out of 245 patients (1 for intensive education group and 2 for conventional education group). Values of each study week were “mean” of all participants on specific study week, but “∆albuminuria (week 8 - week 16)” value was “mean” of ∆ values of “8 weeks-16 weeks” in each individuals. Therefore, values of 3 patients were excluded in “mean of ∆albuminuria (week 8 - week 16)”. That's why simple subtraction (week 8 - week 16) of values are not matched with the data."|changes from week 8 at week 16 (week 8 - week 16)||||mg/day||Standard Deviation|Mean
1371308|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point|"The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371309|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371310|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371311|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point|The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats per minute||90% Confidence Interval|Least Squares Mean
1371312|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371313|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
1371314|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
1371315|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
1371316|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
1371317|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax|The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371318|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371319|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371320|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax||Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats per minute||90% Confidence Interval|Least Squares Mean
1371321|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)|QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
1371322|NCT01552915|Secondary|Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.|||bpm||Standard Deviation|Mean
1371323|NCT01552915|Secondary|Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.|||mmHg||Standard Deviation|Mean
1371324|NCT01552915|Secondary|Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 Weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.|||mmHg||Standard Deviation|Mean
1371510|NCT01550549|Secondary|Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true negatives which are correctly identified|at autopsy, within 2 years of scan||||percentage of negative cases IDed||95% Confidence Interval|Number
1371326|NCT01552915|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.|Baseline and week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1371327|NCT01552902|Other Pre-specified|Change From Baseline in Pulse Rate at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.|||Beats per minute||Standard Deviation|Mean
1371328|NCT01552902|Other Pre-specified|Change From Baseline in Blood Pressure at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1371329|NCT01552902|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 3 days after last dose (last dose at Week 6)|Safety set.|||participants|||Number
1371330|NCT01552902|Secondary|Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6|The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.|Week 6|FAS.|||percentage of participants|||Number
1371331|NCT01552902|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6|The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.|Baseline, Week 6|Full Analysis Set (FAS) was defined as all participants in the Safety set who had at least 1 post-baseline measurement of the ADHD-RS-IV. Not all FAS participants were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1371332|NCT01552889|Secondary|PROMIS Physical Functioning Scale 10a Short Form|This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.|12 months||||units on a scale||Standard Deviation|Mean
1371333|NCT01552889|Secondary|Treatment Satisfaction Scale.|This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.|12 months||||units on a scale||Standard Deviation|Mean
1371334|NCT01552889|Primary|Beck Depression Inventory 2|Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression.|12 months||||units on a scale||Standard Deviation|Mean
1371335|NCT01552876|Other Pre-specified|Phase II: Absolute Rotation|Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.|1-minute during Phase II|Analysis was on those subjects who were enrolled, randomized, and completed the study.|||Degrees|eyes|Standard Deviation|Mean
1371336|NCT01552876|Primary|Phase I: Absolute Lens Rotation|Lens orientation position as assessed on a scale of 0-180 on both eyes.|3 min after lens insertion during Phase I|Analysis was on those subjects who were enrolled, randomized, and completed the study.|||Degrees|eyes|95% Confidence Interval|Least Squares Mean
1371337|NCT01552876|Secondary|Phase I: Number of Blinks Until Settled|Number of blinks for the right eye was counted until lens settling using headcam video.|Baseline to 5 minutes during Phase I|Subjects analyzed are those who were enrolled, randomized, and completed the study.|||Blinks||Standard Error|Least Squares Mean
1371338|NCT01552876|Secondary|Phase I: Time to Lens Settling|With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.|5 minutes after lens insertion during Phase I|Subjects analyzed were those who were enrolled, randomized, and completed the study.|||minutes||95% Confidence Interval|Least Squares Mean
1371339|NCT01552876|Primary|Phase I: Absolute Lens Rotation|At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.|At 1-min after lens insertion during Phase I|Subjects included in the analysis were those who were enrolled, randomized, and completed the study.|||Degrees|eyes|95% Confidence Interval|Least Squares Mean
1371340|NCT01552772|Secondary|CGI-I Scale Score in LOCF Data.|The efficacy of trial medication were rated for each participant using the Clinical Global Impression Improvement (CGI-I) scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
1385418|NCT01402141|Secondary|Changes in Interferon-gamma|Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||IU/ml||Standard Deviation|Mean
1371341|NCT01552772|Secondary|Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
1371342|NCT01552772|Secondary|Change From Baseline in CGI-S Score in LOCF Data.|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 1, 2 and 4.|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
1371343|NCT01552772|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.|The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
1371344|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
1371345|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for OC Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
1371346|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
1371347|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for OC Data.|The Positive and Negative Syndrome Scale (PANSS) consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
1371469|NCT01551056|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371348|NCT01552772|Secondary|Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety extrapyramidal symptoms (EPS) assessment scales.|||Units on a scale||Standard Deviation|Mean
1371349|NCT01552772|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
1371350|NCT01552772|Primary|Number of Participants With Adverse Events (AE).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events.|From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).|The safety analyses dataset consisted of data from all enrolled participants who received one dose of trial medication, regardless of any protocol deviation. All observed data for these participants were included.|||Participants|||Number
1371351|NCT01552694|Secondary|Percent Change in Blood Endothelial Progenitor Cells|Monocytes (PBMC) are isolated from 20 mL blood. CD34+/VEGFR2+/KDR+ monocytes represent cell markers for endothelial progenitor cells (EPC). CD34+/VEGFR2+/KDR+ monocytes are counted (flow cytometry) and expressed as a percentage of PBMC number. Percent change between population averages from baseline to 2 months for the EPC/PBMC ratio is calculated and reported as the outcome measure.|Baseline to 2 months|CD34+/VEGFR2+/KDR+ monocytes (EPC) are a very rare cell type (<1% of PBMC). Not all blood samples contain EPC cells, or there are too few to count reliably. This measure was obtained in a subset of the total participants.|||Percent change|||Number
1371352|NCT01552694|Secondary|Fold Change in Adipose Inflammation Marker CCL2 (MCP-1) mRNA Expression|Adipose tissue from obese, insulin resistant subjects is characterized by increased macrophage infiltration and overexpression of inflammatory cytokines/chemokines. In adipose samples, mRNA expression for the macrophage inflammation marker CCL2 (MCP-1) was quantified. Fold change between population averages from baseline to 2 months for adipose macrophage CCL2 (MCP-1) mRNA expression is the outcome measure.|Baseline to 2 months|Adipose tissue samples were not available from all participants. This secondary outcome includes fewer participants analyzed than the primary outcome.|||fold change|||Number
1371353|NCT01552694|Primary|Inflammatory Biomarker 3: Serum D-dimer Concentration|There are 3 levels of the primary outcome measure, hsCRP, IL-6, and D-dimer|2 months||||µg FEU/mL||Standard Deviation|Mean
1371354|NCT01552694|Primary|Inflammatory Biomarker 2: Plasma IL-6 Concentration|There are 3 levels of the primary outcome measure; hsCRP, IL-6, and D-dimer concentrations measured at baseline and week 8|2 months||||pg/mL||Standard Deviation|Mean
1371355|NCT01552694|Primary|Inflammatory Biomarker 1: Plasma hsCRP Concentration|Fasting serum and plasma samples obtained at baseline and week 8 are batched for ELISA analysis (end of sudy) of hsCRP, IL-6 and D-dimer concentrations.|2 months||||mg/L||Standard Deviation|Mean
1371356|NCT01552681|Secondary|Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one injection site reaction or Grade 2 or higher adverse event within 24 hours of injection are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.|||Percent of participants|||Number
1371357|NCT01552681|Secondary|Percent of Participants With Grade 3 or Higher Infection Adverse Event|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher infection adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.|||Percent of participants|||Number
1371358|NCT01552681|Secondary|Percent of Participants With Adverse Events of Grade 3 or Higher|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.|||Percent of participants|||Number
1371492|NCT01550952|Secondary|Numeric Rating Scale (NRS) Pain Scores With Movement|NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.|2 days postoperatively||||units on a scale||Inter-Quartile Range|Median
1371359|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||units on a scale||Standard Deviation|Mean
1371360|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.|||units on a scale||Standard Deviation|Mean
1371361|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.|||units on a scale||Standard Deviation|Mean
1371362|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.|||units on a scale||Standard Deviation|Mean
1371363|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.|||mm/5 min||Standard Deviation|Mean
1371364|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.|||mm/5 min||Standard Deviation|Mean
1371365|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 48. Data were not available for six participants|||mm||Standard Deviation|Mean
1371493|NCT01550952|Secondary|Number of Participants With Reduced Sensation in a Dermatome|Pin-prick sensation assessed.|2 days postoperatively|Dermatomes could not be assessed for one patient due to sedation|||participants|||Number
1371366|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 24. Data were not available for six participants|||mm||Standard Deviation|Mean
1371367|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||mm||Standard Deviation|Mean
1371368|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.|||mm||Standard Deviation|Mean
1371369|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||mm||Standard Deviation|Mean
1371370|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.|||mm||Standard Deviation|Mean
1371371|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||Percent of participants|||Number
1371372|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and one participant who received placebo.|||Percent of participants|||Number
1371382|NCT01552343|Secondary|Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score|The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); the NI total score is the sum of the 11 core items scores (range of 0-44) which is then transformed to a 0-100 scale (high score indicates high impact). The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. Negative change from baseline scores indicate a decrease in impact caused by nocturia.|Baseline (Day -2 to Day 1), Treatment (Day 28-30)|Full analysis set. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
1371373|NCT01552681|Secondary|Change From Baseline in European League Against Rheumatism (EULAR) Sjogren’s Syndrome Disease Activity Index (ESSDAI) at Week 24|The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Baseline to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had an ESSDAI score at Baseline and Week 24. Data were not available for five participants who received baminercept and two participants who received placebo.|||units on a scale||Standard Deviation|Mean
1371374|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 48|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had unstimulated salivary flow results at Screening and Week 48. Data were not available for six participants who received baminercept and one participant who received placebo.|||mL/min||Standard Deviation|Mean
1371375|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 24|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had an unstimulated salivary flow assessment at screening and week 24. Data were not available for N=7 subjects (e.g., N=5 in baminercept and N=2 in placebo group).|||mL/min||Standard Deviation|Mean
1371376|NCT01552681|Secondary|Change From Screening in Stimulated Whole Salivary Flow at Week 48|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had stimulated salivary flow results at screening and Week 48. Wk 48 stimulated salivary flow results were not available for N=7 subjects (e.g., N=6 in baminercept and N=1 in placebo group).|||mL/min||Standard Deviation|Mean
1371377|NCT01552681|Primary|Change From Screening in Stimulated Whole Salivary Flow at Week 24|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject.|||mL/min||Standard Deviation|Mean
1371378|NCT01552603|Secondary|Mean Deviation From Target Blood Glucose|Mean difference of venous blood glucose from glucose target. Daytime venous blood glucose values (7am-11pm) subtracted from daytime target of 115 mg/dl. Nighttime venous blood glucose values (11pm-7am) subtracted from nighttime target of 140 mg/dl. This is a metric of how successful the closed loop algorithm was at controlling glucose.|all 28 hour studies||||mg/dl||Standard Deviation|Mean
1371379|NCT01552603|Primary|Mean Percent of Time in Target Blood Glucose Range|Mean percent of time venous blood glucose was sampled between 70-180 mg/dl|all 28 hour studies||||percentage of time||Standard Deviation|Mean
1371380|NCT01552343|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e. within one day of the last dose of desmopressin.|Day 1 up to 1 month|Safety analysis set|||participants|||Number
1371381|NCT01552343|Secondary|Minimum Post-Treatment Serum Sodium Levels|Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 up to 1 month|Safety analysis set|||participants|||Number
1371494|NCT01550952|Primary|Hand Grip Strength|Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.|||percent||Inter-Quartile Range|Median
1371383|NCT01552343|Secondary|Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids|"The known group validity was assessed by comparing participants who experienced ≥3 nocturnal voids to those who experienced <3 nocturnal voids, using the average over 3 days for the Screening and Baseline diaries. Results are reported for the NI Total Scores and the Overall Impact Question (Q12).~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.~The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact)."|Screening (Day -20), Baseline (Day 1)|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
1371384|NCT01552343|Secondary|Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values|"Cronbach’s alpha (CA) is a measure of the internal consistency of the Nocturia Impact (NI) Total scores. Higher scores indicate a more reliable (precise) instrument. A value of 0.70 set as the benchmark for declaring the scale as internally consistent.~Cronbach's alpha was assessed for each of the three consecutive days NI diaries were completed during screening (Day -20 to Day -18), baseline (Day -2 to Day 1) and Month 1 (Day 28 to Day 30)."|Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30)|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||ratio of variance||95% Confidence Interval|Number
1371385|NCT01552343|Primary|Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1|"The responsiveness of the NI Diary was measured with Cohen’s D effect size. The effect size was calculated for active treatment versus placebo, based on change from Baseline to Month 1. The effect size was evaluated as “small,” “medium,” or “large” if D was <=0.35, >0.35 - 0.65, or >0.65, respectively.~Mean values are the Cohen's D effect size. Standard deviation is the pooled standard deviation."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
1371386|NCT01552343|Primary|Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders|"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.~The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact).~The difference in mean change in NI total score for subjects who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1 visit (non-responders) versus those with a reduction in nocturnal voids from Baseline of ≥33% (responders) was estimated."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
1371387|NCT01552343|Primary|The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score|"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score.~The correlation was estimated using Fisher’s z transformation, i.e. the NI total score was based on a standardized scale from 0 (lowest impact) to 100 (highest impact).~Corresponding adjusted partial correlation coefficients were based on adjustments for mean number of Baseline voids, Baseline NI total score, age, and gender."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||correlation coefficient||95% Confidence Interval|Number
1371388|NCT01552057|Primary|Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); Last Observation Carried Forward (LOCF) values were used.|||units on a scale||Standard Error|Least Squares Mean
1371389|NCT01552057|Primary|Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 10 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371390|NCT01552057|Primary|Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371391|NCT01552057|Primary|Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 4 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371392|NCT01552057|Primary|Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371393|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371394|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary|Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371395|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371396|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1373761|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest|From surgical incision to last suture has been placed, an expected average of 30 minutes.|||||||
1371397|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant’s quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.|||units on a scale||Standard Error|Least Squares Mean
1371398|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371399|NCT01552057|Secondary|Clinical Global Impression of Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371400|NCT01552057|Secondary|Patients Global Impression of Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371401|NCT01552057|Primary|Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
1371402|NCT01551979|Secondary|Change From Baseline on the Calgary Depression Scale for Schizophrenia|The Calgary Depression Scale for Schizophrenia is a 9-item scale that assesses depressive symptoms in patients with schizophrenia. Each item is rated separately and ratings range from 0 to 3. Higher values represent more severe depressive symptoms: 0 indicates an absent symptom and 3 indicates a severe symptom. The overall Calgary Depression Scale score is computed by summing each item. The total Calgary Depression Scale score ranges from 0 to 27, with higher values representing more severe depression in patients with schizophrenia. Change from baseline on the Calgary Depression Scale can range from -27 to +27, with negative values representing an improvement in depressive symptoms and positive values representing worsening depressive symptom severity. Depression was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
1371403|NCT01551979|Primary|Clinical Global Impression (CGI) Global Improvement|Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient’s illness has changed compared to baseline. Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
1371468|NCT01551056|Secondary|Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371404|NCT01551979|Primary|Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness|Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient’s illness at the time of assessment. Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients. Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
1371405|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
1371406|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
1371407|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
1371408|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg/mL||Standard Deviation|Mean
1371409|NCT01551888|Secondary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg*hr/mL||Standard Deviation|Mean
1371410|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg/mL||Standard Deviation|Mean
1371411|NCT01551888|Primary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg*hr/mL||Standard Deviation|Mean
1371412|NCT01551758|Secondary|Number of Participants With Serious Adverse Drug Reactions|A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Upto 12 months|ITT Population|||Participants|||Number
1371413|NCT01551758|Secondary|Number of Participants With Serious Adverse Events|SAEs assessed included medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a significant medical event in the investigator's judgment, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. SAEs were includes if the onset date was on or after the treatment start date and on or before the treatment stop date. However, the window for an SAE of pneumonia was longer and included 28 days post study treatment stop date.|Up to 56 weeks|ITT Population|||Participants|||Number
1371414|NCT01551758|Secondary|Number of Participants With Non-serious Adverse Drug Reactions (ADR)|The number of participants with non-serious ADRs was assessed for up to 54 weeks. An ADR is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. A non-serious ADR included one of the following: exacerbation of chronic or intermittent pre-existing condition; signs, symptoms, or the clinical sequelae of a suspected interaction; signs, symptoms, or new conditions detected or diagnosed after study treatment administration.|Up to 54 weeks|ITT Population|||Participants|||Number
1371415|NCT01551758|Secondary|Number of Participants With Fatal Serious Adverse Events of Pneumonia|All SAEs included in the AE subgroup of special interest of “pneumonia” were considered as an SAE of pneumonias. A fatal SAE was defined as a SAE with outcome of fatal for study participant. The number of participants with fatal SAEs of pneumonia was assessed over 14 months.|Upto 58 weeks|ITT Population|||Participants|||Number
1371416|NCT01551758|Secondary|Time to First Severe Exacerbations Occurring in a Year|"The date of an event for severe exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe exacerbation were censored. The analysis method was a Cox proportional hazards model adjusted for randomized treatment.~The probability of first severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first severe exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any severe exacerbations (censored). At Day 364, all participants who have not experienced a severe exacerbation are considered censored, regardless of whether their on-treatment phase continues beyond day 364, including those who withdrew early. Number of participants with event is presented."|Up to 364 days|ITT Population|||Participants|||Number
1371417|NCT01551758|Secondary|Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year|The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of first moderate / severe exacerbation on initial therapy was measured from the date of randomisation (i.e., exposure start date) to the onset date of first moderate or severe COPD exacerbation, or to the date of discontinuation of initial therapy (analysis was censored at date of discontinuation of initial therapy) for participants who completed the study without any moderate or severe exacerbations on initial therapy. Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
1371418|NCT01551758|Secondary|Time to First Moderate/Severe Exacerbations Occurring in a Year|The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of a first moderate / severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first moderate or severe COPD exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any moderate or severe exacerbations (censored). Participants who completed the study without a moderate or severe COPD exacerbation and analyses of time to first moderate/severe exacerbation were censored at Day 364. Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
1371419|NCT01551758|Secondary|Time to the Addition of a Further COPD Controller Medication Occurring in a Year|The date of an event for addition of a further COPD controller medication was defined as the exposure start date of the first modified treatment medication that included a new COPD maintenance therapy of a new class of drug (to the initial therapy) during the study treatment period, as collected on the investigational product page of the eCRF. Participants who did not add any COPD controller medication during the study were censored at the end of the treatment period (Day 364). This was equivalent to stepping up, defined as the addition of at least one new class of drug. The probability of an event was measured from the date of randomisation (i.e., treatment initiation) to the date of a change event. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
1371420|NCT01551758|Secondary|Time to an Event of Discontinuation of Initial Therapy Occurring in a Year|Initial therapy was defined as the treatment that the subject was randomised to at randomisation. Discontinuation of initial therapy was defined as any modification of initial therapy. These included stepping up, stepping down or switching to another class/class combination, or withdrawal from the study. Switching within the same drug class did not count unless participant switched from FF/VI to a different ICS/LABA. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of discontinuation of initial therapy was measured from the date of randomisation (i.e., exposure start date) to the date of discontinuation of initial therapy to which the participant was randomized, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without discontinuing the initial therapy (censored). Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
1371421|NCT01551758|Secondary|Number of All Primary Care Contacts Expressed Using Least Square Mean|A primary care contact was defined as contact with a either a nurse, general practitioner, or other healthcare professional. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
1371431|NCT01551745|Primary|Response Rate|Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.|Up to 12 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
1371495|NCT01550952|Primary|Anterior Deltoid Strength|Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.|||percent||Inter-Quartile Range|Median
1371422|NCT01551758|Secondary|Number of All Secondary Care Contacts Expressed Using Least Square Mean|A secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an A&E contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. In the situation where inpatient admissions were recorded at two hospitals on the same day, this was counted as a single secondary care contact. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomization stratification, number of moderate/severe COPD exacerbations in the previous year to randomization and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
1371423|NCT01551758|Secondary|Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean|A COPD-related primary care contact was defined as a primary care contact on a given calendar date with either a nurse, general physician (GP) or other healthcare professional that were considered as COPD-related, if the most prominent signs and symptoms the participant was presenting were as a direct result of the participant's COPD, as per Readcodes recorded in the patients electronic health record (EHR). The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
1371424|NCT01551758|Secondary|Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean|A COPD-related secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an accident & emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. Inpatient admissions recorded at two hospitals on the same day, this was counted as a single (inpatient admission) secondary care contact. COPD-related contacts were identified using predefined lists of ICD-10 codes, specialty descriptions and diagnosis codes recorded in the patients electronic health record (EHR). GLM assuming the negative binomial distribution with log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
1371425|NCT01551758|Secondary|Time to the First Serious Adverse Event of Pneumonia Occuring in a Year|The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Analyses included those on-treatment SAEs of pneumonia that had an onset over the first 364 days of exposure, as defined. Participants who did not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to end date of exposure + 28 days were considered censored. Number of participants with event is presented.|Up to 52 weeks|ITT Population|||Participants|||Number
1371426|NCT01551758|Secondary|Mean Number of Serious Adverse Events of Pneumonia During the Study|The mean number of SAE of pneumonia over the treatment period (from first date of exposure to last date of exposure + 28 days was calculated. Analysis was performed using a negative binomial regression model with covariates of randomised treatment and with logarithm of time on treatment as an offset variable.|Up to 58 weeks|ITT Population.|||Mean Number of SAE||95% Confidence Interval|Least Squares Mean
1371427|NCT01551758|Secondary|Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study|Incidence of SAE of pneumonia was defined for each randomized treatment group as the proportion (number) of participants in that group who experienced at least one SAE of pneumonia in the Pneumonia Adverse Event of Special Interest subgroup during the treatment period (from start date of exposure to stop date of exposure + 28 days). Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2. Serious Adverse Events of pneumonia are defined by the Pneumonia Special Interest Group, which for SAEs of pneumonia collected for these subjects includes the following preferred terms: Pneumonia, Pneumonia aspiration, Aspergillus infection, Empyema, Pneumonia streptococcal, Pneumonitis, Pulmonary tuberculosis.|Up to 58 weeks|The Intent-to-Treat (ITT) Population: Defined as all participants who were randomised and received at least one prescription of study medication|||Participants|||Number
1371428|NCT01551758|Primary|Mean Annual Rate of Moderate or Severe COPD Exacerbations|Mean annual rate of moderate or severe COPD exacerbations during treatment were assessed. Moderate exacerbation: participant received exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with/without National Health Service [NHS] contact) not requiring hospitalisation. Severe exacerbation: an exacerbation-related hospitalisation. Analysis method was Generalised Linear Model (GLM) assuming the negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable, adjusted for randomized treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in previous year and smoking status at baseline. Intent to treat (ITT) population: all randomised participants who received a prescription of study medication. Primary Efficacy Analysis Population: all ITT participants who had at least one moderate/severe exacerbation in the year prior to randomization|Up to 54 weeks|Primary Efficacy Analysis Population.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
1371429|NCT01551745|Secondary|Enzyme-Linked ImmunoSorbent Spot (ELISPOT)|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.|Baseline, End of Treatment (30 days after last dose) up to 12 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 12 months, all 5 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
1371430|NCT01551745|Secondary|Number of Alive Subjects|Survival status of patients after treatment was determined by following these patients up to 24 months.|24 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 24 months, only 1 of the 5 subjects was alive. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
1371432|NCT01551745|Primary|Time to Progression|Time to progression (TTP) following bevacizumab integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.|24 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
1371433|NCT01551693|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Patients were followed every 4 weeks for survival until death, lost to follow-up or study closure (approximately 6 months after the last patient ended treatment). In this study cohort, patients were followed up to 13 weeks.|Overall survival was not estimated given the limited sample size.||||||
1371434|NCT01551693|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Median (range) treatment duration was 1 cycle/4 weeks (1-2 cycles; 4-8 weeks).||||participants|||Number
1371435|NCT01551693|Primary|6-month Progression-Free Survival Rate|6-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 6 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until evidence of disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 6 months.||||proportion of participants|||Number
1371436|NCT01551355|Secondary|Body Mass Index - BMI|The body mass index (BMI), or Quetelet index, is a measure of relative weight based on an individual's mass and height = Kg/m²|baseline||||Kg/m²||Standard Deviation|Mean
1371437|NCT01551355|Secondary|KAH Score for Teachers|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among teachers after 5 months of intervention as compared to prior to intervention.~Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).~We developed questionnaires to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 37 teachers in healthy habits arm and 35 teachers in usual curriculum arm.|||units on a scale||95% Confidence Interval|Mean
1371438|NCT01551355|Secondary|KAH Score for Parents|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among parents after 5 months of intervention as compared to prior to intervention.~Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).~Questionnaires were developedheae to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 402 parents in healthy habits arm and 360 parents in usual curriculum arm.|||units on a scale||95% Confidence Interval|Mean
1371439|NCT01551355|Primary|Change in KAH Score for Children|"Change in weighted knowledge, attitude, habit (KAH) (70/20/10) score among children after 5 months of intervention as compared to prior to intervention.~The study hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, differential weights (70, 20, and 10, respectively) were given to the scores a priori to compose a standardized weighted total score (WTS).~The developed questionnaires measured knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100~Higher values represent a better outcome"|at baseline and at 6 months|"The analysis was done with children that answered al questions in 3 topics: knowledge, attitudes and habits.~Change Score in Weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention."|||units on a scale||95% Confidence Interval|Mean
1371466|NCT01551056|Secondary|Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371440|NCT01551303|Primary|Affective Ratings in Affective Learning Task|"We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so better or worse outcome."|30 minutes after drug administration||||units on a scale||Standard Error|Mean
1371441|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|3-month follow-up (approximately week 26)||||units on a scale||Standard Deviation|Mean
1371442|NCT01551199|Secondary|Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)|The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.|3 Months||||percentage of participants|||Number
1371443|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|1-week post-treatment (approximately week 14)||||units on a scale||Standard Deviation|Mean
1371444|NCT01551173|Secondary|Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint|LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels < 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels < 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect.|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit|||Percent of participants|||Number
1371445|NCT01551173|Secondary|Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit|||mmol/L||Standard Error|Mean
1371446|NCT01551173|Primary|Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.|Baseline, week 12|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit|||Percent change||Standard Error|Mean
1371447|NCT01551095|Secondary|Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement|An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.|From date of PEGJ placement up to 3 weeks||||participants|||Number
1371448|NCT01551095|Primary|Safety: Number of Participants With Adverse Events|One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.|From date of PEGJ placement up to 3 weeks||||participants|||Number
1371449|NCT01551082|Primary|Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes|Outcome measures for this study were to correlate outpatient chest tube management with patient satisfaction. Also to correlate decreased length of stay without compromising any patient outcomes.|2 years|Study was terminated and no data were collected for the outcome||||||
1371450|NCT01551056|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1371467|NCT01551056|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1385419|NCT01402141|Secondary|Changes in Serum Histamine|Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||μg/g creatinine||Standard Deviation|Mean
1371451|NCT01551056|Secondary|Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||%participants with at least 1 nasal symp|||Number
1371452|NCT01551056|Secondary|Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||%participants with at least 1 nasal symp|||Number
1371453|NCT01551056|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371454|NCT01551056|Secondary|Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371455|NCT01551056|Secondary|Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371456|NCT01551056|Secondary|Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371457|NCT01551056|Secondary|Nasal Pruritis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371458|NCT01551056|Secondary|Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371459|NCT01551056|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371460|NCT01551056|Secondary|Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371461|NCT01551056|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371462|NCT01551056|Secondary|Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371463|NCT01551056|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371464|NCT01551056|Secondary|Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371465|NCT01551056|Secondary|Chemosis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371508|NCT01550549|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|Baseline scan||||percentage of true positives/negatives||Full Range|Median
1371470|NCT01551056|Secondary|Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
1371471|NCT01551056|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1371472|NCT01551056|Primary|Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1371473|NCT01551056|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1371474|NCT01551056|Primary|Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1371475|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of activity impairment||Standard Deviation|Mean
1371476|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage|WPAI-SHP is a questionnaire used to assess the effect of the participant’s health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The overall work impairment data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of overall work impairment||Standard Deviation|Mean
1371477|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of impairment while working data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of impairment while working||Standard Deviation|Mean
1371478|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of work time missed data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of work time missed||Standard Deviation|Mean
1371479|NCT01550965|Secondary|Mean Change From Baseline in European Quality of Life – 5 Dimensions – 5 Level (EQ-5D-5L) Total Score|EQ-5D-5L Total Score provides a descriptive profile of health status. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems). A unique EQ-5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from -0.594 to 1, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1385420|NCT01402141|Secondary|Changes in Immunoglobulin E|Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||IU/mL||Standard Deviation|Mean
1371480|NCT01550965|Secondary|Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)|The SCCAI measures disease activity as assessed by the investigator and includes the following 6 items: bowel frequency (day), bowel frequency (night), urgency of defecation, blood in stool, general well-being and extra colonic features. The score ranges from 0 (best) to 19 points (worst).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1371481|NCT01550965|Secondary|Mean Change From Baseline in Physician's Global Assessment (PGA)|The Physician’s Global Assessment was used to measure the participant’s disease activity. The physician considered the participant’s reported information such as number of stools, rectal bleeding, abdominal discomfort, and functional assessment during the previous day prior to the visit, and other observations such as physical findings, and the participant’s performance status at the time of the visit. Based on the above information the investigator made an overall assessment of participant’s current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1371482|NCT01550965|Secondary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1371483|NCT01550965|Secondary|Percentage of Participants With Absence of Blood in Stool|Participants with absence of blood in stool were reported.|Week 26|All participants in the ITT population with evaluable data.|||percentage of participants|||Number
1371484|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures|UC-related outpatient utilization was determined from the health care utilization information. Outpatient utilization was the number of procedures/surgeries performed during outpatient visits. Participants without any outpatient utilization were excluded.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Procedures/ Surgeries||Standard Deviation|Mean
1371485|NCT01550965|Secondary|Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a questionnaire to be completed by the participants to determine their satisfaction of the medications for ulcerative colitis including the study drug. The TSQM is a 14-item subject-rated scale that evaluates the effectiveness, side effects, convenience, and global satisfaction of the medication over the past 2-3 weeks. Each of the 14 questions are scored from 1 (worst) to 7 points (best); and each of the domains are scored from 0 (less satisfaction) to 100 (better satisfaction). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1371486|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization|Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Days||Standard Deviation|Mean
1371487|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs|UC-related direct and indirect health care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments, medications and indirect costs based on WPAI.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Pound Sterling (GBP)||Standard Deviation|Mean
1371488|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Pound Sterling (GBP)||Standard Deviation|Mean
1371489|NCT01550965|Primary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Pound Sterling (GBP)||Standard Deviation|Mean
1371490|NCT01550965|Primary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score|The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1371491|NCT01550952|Secondary|Total Oral Opioid Intake in 48hrs|Opioid Usage|0-48hrs||||mg||Standard Deviation|Mean
1371496|NCT01550809|Secondary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Above the Threshold of 140 mg/dl (AUC-PG>140).|"The AUC-PG>140 during the 5-hour period following the meal test represents the hyperglycemic risk related to the modality of prandial insulin administration.~Plasma glucose (PG) for calculation of AUC-PG>140 was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. the 5-hour postprandial period||||mg*h/dl||Standard Deviation|Mean
1371497|NCT01550809|Primary|The Area Under the Curve (AUC) of the Glucose Infusion Rate (GIR) During the 5-hour Postprandial Period (AUC-GIR0-5h).|"The amount of glucose infused during the 5-hour postprandial period (AUC-GIR0-5h) is a measure of the hypoglycemic exposure associated with the modality of prandial insulin administration. Indeed, glucose will be infused only when patients are under a predefined blood glucose values (80 mg/dl) with a descending trend.~Glucose infusion rate (GIR) for calculation of AUC-GIR was measured every minute following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours.||||mg/kg||Standard Deviation|Mean
1371498|NCT01550809|Primary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Concentrations During the 5-hour Postprandial Period (AUC-PG0-5 h).|"AUC-PG0-5 h (5-hour postprandial glucose following the mixed meal test) is a measure of the overall glucose-lowering efficacy of the insulin bolus. The lower the AUC-PG0-5 h without hypoglycemia, the greater the effectiveness of the prandial insulin administration to control the meal related glucose excursion.~Plasma glucose (PG) for calculation of AUC-PG was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours|This was a proof-of-concept study. However, as an estimation of N, a two-sided t-test achieved 84% power to infer that the mean difference was not 0 when the total sample size of a 2x2 crossover design was 12, the actual mean difference in the AUC-PG0-5 h was 100mg*dl-1*h, the square root of the within mean square error was 75.0 and alpha was 0.05.|||mg*h/dl||Standard Deviation|Mean
1371499|NCT01550757|Primary|A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.|A primary outcome for this study is non-acute emergency department visits.|Two years.|Veterans enrolled in the study based on the type of care they received at VA and then randomized to receive a peer or not.|||number of visits||Standard Deviation|Mean
1371500|NCT01550744|Secondary|The Percentage of Participants With a PASI 75 Response Over Time|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.|||percentage of participants|||Number
1371501|NCT01550744|Secondary|The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.|||number of visits||Standard Deviation|Mean
1371502|NCT01550744|Secondary|The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time|Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.|||percentage of participants|||Number
1371503|NCT01550744|Primary|The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)|Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.|||number of visits||95% Confidence Interval|Mean
1371504|NCT01550705|Secondary|Participants With Increased Sun Sensitivity|Study participants were asked to report after 3 months if they had experienced an increase in subjective measures of sun sensitivity during the trial. Reported outcome is the number of study participants who reported increased sun sensitivity|Baseline and 3 Months||||participants|||Number
1371505|NCT01550705|Primary|Change in Plasma Protoporphyrin IX Level|Plasma Protoporphyrin IX will be measured at baseline and at 3 months|Baseline and 3 Months||||µg/dL||Standard Deviation|Mean
1371506|NCT01550549|Post-Hoc|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|Baseline scan||||florbetapir scans|||Number
1371507|NCT01550549|Post-Hoc|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|Baseline scan||||florbetapir scans|||Number
1371511|NCT01550549|Secondary|Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true positives which are correctly identified|at autopsy, within 2 years of scan||||percentage of positive cases IDed||95% Confidence Interval|Number
1371512|NCT01550549|Primary|Inter-rater Reliability|Measure of agreement among five readers using a binary read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.|Scan acquired 50-60 min post-injection|59 autopsy subjects (study A07[NCT00857415]/A16[NCT01447719]) + 20 healthy controls + 20 mild cognitive impairment + 20 AD (from study A05[NCT00702143])|||kappa statistic||95% Confidence Interval|Number
1371513|NCT01550510|Secondary|Number of Participants That Are Alive After 11 Weeks.|To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer|9 weeks +/- 2 weeks|The study was closed early due to lack of accrual. The data were not collected or analyzed.||||||
1371514|NCT01550510|Primary|Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|9 weeks +/- 2 weeks|The study was closed early due to lack of accrual. The data were not collected or analyzed.||||||
1371515|NCT01550302|Secondary|Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension||24 and 48 hours after the surgery|Hypotension data not collected|||Participants|||Count of Participants
1371516|NCT01550302|Secondary|Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication||48 hours after the surgery||||number of participants|||Number
1371517|NCT01550302|Secondary|Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or with movement/cough|||units on a scale||Standard Deviation|Mean
1371518|NCT01550302|Secondary|Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or moving/with cough|||units on a scale||Standard Deviation|Mean
1371519|NCT01550302|Secondary|Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or with movement/coughing|||units on a scale||Standard Deviation|Mean
1371520|NCT01550302|Secondary|Post-operative Opioid Consumption Expressed in Morphine Equivalents||24 hours after the surgery||||mg||Standard Deviation|Mean
1371521|NCT01550302|Primary|Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain||24 hours after lung surgery||||Participants|||Count of Participants
1371522|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.|||Titer ratio||95% Confidence Interval|Geometric Mean
1371523|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1371524|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.|||Titer ratio||95% Confidence Interval|Geometric Mean
1371525|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1371567|NCT01549873|Secondary|Amplitude of the SSEPs|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. The amplitude is the voltage of the electrical stimulation recorded.|day of surgery||||microvolt||Standard Deviation|Mean
1371526|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
1371527|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
1371528|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
1371529|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
1371530|NCT01550289|Primary|Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.|Day 0 up to Day 14 post each injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.|||Percentage of participants|||Number
1371531|NCT01550289|Primary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.|||Titer ratio||95% Confidence Interval|Geometric Mean
1371532|NCT01550289|Primary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1371533|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
1371534|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
1371535|NCT01550224|Secondary|Overall Survival (OS) at 2 Years|Overall Survival (OS) is defined as survival regardless of clinical status. OS is reported as the percentage without dispersion of participants in Groups 1 and 2 that remained alive 2 years after induction chemotherapy.|2 years||||Participants|||Count of Participants
1371536|NCT01550224|Secondary|Relapse-Free Survival (RFS) at 2 Years|"Relapse-free survival (RFS) is defined as survival after complete response (CR) or (PR) without further disease progression. RFS is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced CR or PR, and were alive without progression 2 years after induction chemotherapy. CR and PR are defined as the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL~PR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|2 years||||Participants|||Count of Participants
1372768|NCT01536067|Secondary|Progression-free Survival||From start of treatment to disease progression or death (regardless of the cause of death), whichever comes first, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1371537|NCT01550224|Secondary|Disease-free Survival (DFS) at 2 Years|"Disease-Free Survival (DFS) is defined as survival after complete response (CR) without disease progression. DFS is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced CR and were alive without progression (ie, without disease) 2 years after induction chemotherapy. CR is defined as all of the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|2 years||||Participants|||Count of Participants
1371538|NCT01550224|Secondary|Treatment Failure (TF)|"Treatment failure (TF) is defined as failing to achieve either a complete remission (CR) or partial remission (PR) after induction chemotherapy. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced TF. CR and PR are defined as the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL~PR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
1371539|NCT01550224|Secondary|Partial Remission (PR)|"Partial remission (PR) is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated PR. PR is defined as all of the following.~PR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
1371540|NCT01550224|Secondary|Cytogenetic Response (CyR)|"Cytogenetic response (CyR) is defined as complete remission (CR), PLUS a documented decrease or absence of cytogenetic abnormalities, when analyzed microscopically for 20 cellular metaphases (actively dividing cells). The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated CyR. CR is defined as all of the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
1371541|NCT01550224|Secondary|Complete Remission With Incomplete Blood Count Recovery (CRp)|"The rate of complete remission with incomplete blood count recovery (CRp) for Groups 1 and 2 was assessed as the rate of morphologic leukemia-free state (MLFS) but with EITHER residual neutropenia (ANC < 1,000/µL) OR residual thrombocytopenia (PLT < 100,000/µL). MLFS is defined as follows.~MLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease"|up to 10 weeks||||Participants|||Count of Participants
1371542|NCT01550224|Secondary|Morphologic Leukemia-free State (MLFS)|"The rate of morphologic leukemia-free state (MLFS) is reported as the percentage without dispersion of participants in Groups 1 and 2 that achieve MLFS. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated MLFS. This assessment is independent of absolute neutrophil count (ANC) or platelets (PLT) recovery status. MLFS is defined below.~MLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease"|up to 10 weeks||||Participants|||Count of Participants
1371543|NCT01550224|Primary|Complete Remission (CR)|"This study evaluates the clinical efficacy of temozolomide + vorinostat as administered to Groups 1 and 2, assessed as the rate of complete remission [CR, aka morphologic complete remission (mCR)], defined as the morphologic leukemia-free state (MLFS), WITH absolute neutrophil count (ANC) ≥ 1,000/µL AND platelets (PLT) ≥ 100,000/µL. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated CR. CR is defined as all of the following.~MLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease ANC = ≥ 1,000/µL PLT = ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
1371544|NCT01549977|Secondary|Percentage of Participants Stopping ETT Due to Angina at Week 12|The percentage of participants who had to stop exercise treatment testing (ETT) due to experiencing angina symptoms at Week 12.|Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
1371545|NCT01549977|Secondary|Change From Baseline in Maximum ST-segment Depression During ETT at Week 12|The change between the maximum ST-segment depression during ETT at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
1371546|NCT01549977|Secondary|Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12|The change between the time to onset of ≥1 mm ST-segment depression during exercise treadmill test (ETT) at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
1371547|NCT01549977|Secondary|Change From Baseline in Time to Onset of Angina During ETT at Week 12|The change between the time to onset of angina during the exercise treadmill test (ETT) at Week 12 relative to Baseline.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
1371548|NCT01549977|Primary|Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12|The change between the duration of ETT at Week 12 relative to Baseline. ETTs were conducted using the modified Bruce Protocol. Participants exercised on a treadmill, starting at 1.7 mph and 0% incline. The intensity of exercise (speed and/or incline) was increased at 3 minute intervals.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
1371568|NCT01549873|Primary|Amplitude Required to Elicit the MEP|Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).|at time of surgery||||milliamperes||Standard Deviation|Mean
1371549|NCT01549964|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 relative to Baseline. A MMRM model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.|||mg/dL||Standard Error|Least Squares Mean
1371550|NCT01549964|Secondary|Incidence of HbA1c <7%|Incidence (percentage) of participants with glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than 7% at Week 24.|24 Weeks|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized|||percentage of participants|||Number
1371551|NCT01549964|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A Mixed Model Repeated Measures (MMRM) model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.|||Percent||Standard Error|Least Squares Mean
1371552|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in ECG|The number of participants who reported clinically significant abnormalities in ECG were measured throughout study. ECGs were performed after the participant had been supine for at least 10 minutes.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1371553|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1371554|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs|The number of participants with any clinically significant abnormalities in vital signs collected throughout study. Vital signs included body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1371555|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values|The number of participants with any clinically significant abnormalities in safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1371556|NCT01549951|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1371557|NCT01549951|Secondary|Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1371558|NCT01549951|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.|||hours||Full Range|Median
1371595|NCT01548833|Primary|Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.|Day 7, 16 hours after lens insertion||||seconds||Standard Deviation|Mean
1371559|NCT01549951|Secondary|AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite|AUC(0-6) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 6 hours in this study). Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|Pharmacokinetic (PK) population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
1371560|NCT01549951|Secondary|Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel|Coefficient of correlation was measured using linear mixed effects model for the association between two variables; change from baseline versus the plasma concentration. Participant’s effects on the intercept and plasma concentration slope were included in the model as random effects terms. Plasma concentrations were re scaled for model convergence. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||correlation coefficient||Standard Error|Least Squares Mean
1371561|NCT01549951|Secondary|Number of Participants Reporting Change From Baseline in ECG Morphology|Participants with incidence of ECG morphology abnormalities were observed. Types of abnormalities included appearance of abnormal U waves, T waves inversion, elevation of ST segment, depression of ST segment, second or third degree heart block, right or left bundle branch block, atrial fibrillation/flutter, and myocardial infarction. New morphological changes were observed in abnormal U waves, depression of ST segment, and T waves inversion. Here, 'new' refers to change not present at baseline, ie, at any evaluation predose, and only seen postbaseline. Results of change in ECG morphology analyzed from 12-lead ECGs at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||participant|||Number
1371562|NCT01549951|Secondary|Changes From Baseline in Heart Rate|Triplicate 12-lead Electrocardiogram (ECG) measurements were performed and average was calculated. Supine heart rate was measured as beats per minute (bpm). Results of change in heart rate analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||bpm||Standard Deviation|Mean
1371563|NCT01549951|Secondary|Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 1 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette’s formula (QTcB = QT divided by square root of RR). Results of change in QTcB, PR, QRS and uncorrected QT analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||msec||Standard Deviation|Mean
1371564|NCT01549951|Primary|Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||millisecond (msec)||Standard Deviation|Mean
1371565|NCT01549925|Primary|Surgical Time|To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures|at time of surgery, up to 10 minutes||||SECONDS||95% Confidence Interval|Mean
1371566|NCT01549873|Secondary|Latency of the SSEP’s|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. Latency is the time interval between the stimulation and response.|day of surgery||||milliseconds||Standard Deviation|Mean
1371569|NCT01549860|Secondary|Change in Pain VAS Scores|"Compare VAS Pain Scores between arms at baseline and 4 weeks post randomization~Subjects indicate their pain level by drawing a mark on a 10 cm line on a visual analog scale (VAS) at randomization and 4 week post treatment visit. The left end of the line indicates no pain and the right end of line indicates worst pain imaginable. VAS score is determined by using a ruler placed at 0 (left end of scale) and measuring the distance from zero to the patient's mark . The objective is to compare the change in VAS values in MIST+SC to SC alone.~H0: The average change in pain level is not different between MIST and SC HA: The average change in pain level is different between MIST and SC H0: µMIST = µSC vs HA: µMIST ≠ µSC,~Statistical Analysis. A repeated measures ANCOVA will be used to test for differences in change in VAS with an indicator variable to indicate treatment, any demographic variables which were significant in the baseline comparisons."|Baseline, 2 weeks and 4 weeks post randomization|Eligible Subjects Randomized|||VAS pain level measured in centimeters||Full Range|Median
1371570|NCT01549860|Secondary|Heal Rates|Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.|12 weeks post randomization|Eligible subjects randomized|||participants|||Number
1371571|NCT01549860|Primary|Wound Area Mean Percent Reduction|"Compare between the treatment groups percent wound area reduction at four weeks of study treatment.~H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size."|4 weeks post baseline visit (randomization visit)|eligible subjects that were randomized|||percentage of mean area reduction||Standard Deviation|Mean
1371572|NCT01549613|Secondary|Digital and Infrared Imaging|Change in lesion area and temperature|Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.|||||||
1371573|NCT01549613|Primary|Satisfaction of Discharge Criteria|RDTC cellulitis protocol discharge criteria|Time point at which outcome measure is assessed 30 days from the date of admission.||||participants|||Number
1371574|NCT01549405|Primary|Total Consumption of Tramadol Will be Measured for the First 24 Hours||Postoperative 24th hour||||mg||Standard Deviation|Mean
1371575|NCT01549405|Secondary|Postoperative Pain Will be Evaluated.|The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.(“0” no pain, to “10”, the maximum pain )Pain score less then 4 is acceptable.|24 hours||||units on a scale||Inter-Quartile Range|Median
1371576|NCT01549405|Primary|Postoperative Analgesic (Tramadol) Consumption|Total consumption of tramadol will be measured for the first 24 hours.|Postoperative 24th hour|||||||
1371577|NCT01549392|Primary|3 Month Response|participants who had reduction of tumor size from avastin at 3 months|at 3 months after initial DECT and MR spectroscopy||||participants who had tumor reduction|||Number
1371578|NCT01549340|Secondary|Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone|The mean duration in years of SCIT or SLIT treatment for all participants with AR and asthma and for all participants with AR only was calculated. Duration of SCIT or SLIT treatment was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR and asthma or AR alone who were advised by their physician to receive AIT to treat their AR and who initiated AIT.|||years||Standard Deviation|Mean
1371579|NCT01549340|Secondary|Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT|The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.|Up to 5 years|The analysis population consisted of those participants with AR and asthma who were advised by their physician to receive AIT to treat their AR and who initiated SCIT or SLIT.|||percentage of participants|||Number
1371580|NCT01549340|Primary|Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course|The reason for discontinuation of SCIT or SLIT treatment more than 6 months before completion of the recommended course of therapy was recorded. The percentage of participants whose records were reveiwed and who discontinued SCIT or SLIT due to different reasons was calculated.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR, who initiated and subsequently discontinued AIT, and had their charts reviewed for the reason for discontinuation.|||percentage of participants|||Number
1371581|NCT01549340|Primary|Duration of Treatment With SCIT or SLIT|The mean duration in years of SCIT or SLIT treatment for all participants with AR who initiated SCIT or SLIT was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.|||years||Standard Deviation|Mean
1371582|NCT01549340|Primary|Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment|The percentage of participants who initiated SCIT or SLIT and completed 5 years of treatment was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled. If extract refills continued past the recommended time for therapy (e.g. 5 years from the start of therapy), the participant was deemed successful in completing the recommended course. If the extract refills stopped prior to the end of the recommended time for therapy, but the last refill occurred within 6 months of the recommended time for therapy, this participant was deemed successful in completing the recommended course.|At 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.|||percentage of participants|||Number
1371583|NCT01549340|Primary|Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops|The percentage of participants who were advised by their physician to start AIT and elected to initiate AIT was calculated. AIT initiation was broken down by type of AIT initiated (SCIT or SLIT).|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR.|||percentage of participants|||Number
1371584|NCT01549275|Secondary|Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells|104 Patients with complete follow-up data were further divided into receiving (1) curative treatment of HCC including operative resection and local ablation therapy, (2) palliative transcatheter arterial chemoembolization (TACE), and (3) supportive treatment.|6 months after plating of cells|Correlation between the growth speeds of cultured cells and worsening of AJCC TNM stages or HCC related death 6 months after plating of cells|||participants|||Number
1371585|NCT01549275|Primary|Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study.|Patients were divided into AJCC TNM staging < = IIIA and > = IIIB two groups. The incidences of patients with rapidly proliferative cultured cells in these two groups were compared. Rapidly proliferative group was defined as (1) growth area of cultured cells at the 28th day of primary culture exceeded two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 28th day reached > 70% growth area of the flask. Based on the results from special stain, patients in rapidly proliferative group were further divided into patients with rapid proliferation of HCC cells alone, rapid proliferation of HCC cells with concomitant cancer-associated fibroblasts (CAFs) (HCC + CAFs) and CAFs alone.|28 days after plating of cells|Comparison the incidence of patients with rapidly proliferative cultured cells between two groups|||participants|||Number
1371586|NCT01549223|Secondary|Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use|Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.|Up to 15 min from time of infant delivery|All side effects: hypotension, flushing, nausea and emesis|||Participants|||Count of Participants
1371587|NCT01549223|Primary|1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.|Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.|Up to 15 min from time of infant delivery||||IU||Standard Deviation|Mean
1371588|NCT01549041|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7 with 1 representing the lowest severity of symptoms and 7 representing the highest severity; thus the lowest and highest possible total scores are 18 and 126|From baseline to day 14||||units on a scale||Standard Error|Mean
1371589|NCT01549041|Primary|Patient Acceptance|A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment.|At day 14||||units on a scale||Standard Error|Mean
1371590|NCT01549002|Secondary|Number of Patients Satisfied With Analgesia Administered|"Number of patients satisfied with analgesia administered will be evaluated by determining the number of patients who report a Likert scale response of somewhat satisfied, very satisfied, or extremely satisfied (i.e. any patient who selects any of these three responses will be considered to have been satisfied with analgesia administered). Patients will be asked 10 minutes after procedure completion. If the patient is 8 years of age and older, both the patient and the parent or guardian will complete a satisfaction survey. If the patients is younger than 8 years, their parent or guardian will complete the satisfaction survey."|10 minutes after procedure completion|Patient satisfied with analgesia administered|||Participants|||Count of Participants
1371591|NCT01549002|Secondary|Score on the Faces Pain Scale Revised (FPS-R)|"The Faces Pain Scale - Revised (FPS-R) is a self-report measure of pain has strong validity and reliability in children 4 - 17 years of age undergoing painful procedures, and will be used to assess patients' self reported pain. A score of 0 means no pain, a score of 10 means very much pain. Therefore, a lower score indicates that a patient is experiencing a lower degree of pain intensity.~Patients will complete the FPS-R at four times during their medical encounter: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion."|Up to 10 minutes after procedure completion|(1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion.|||units on a scale||Inter-Quartile Range|Median
1371592|NCT01549002|Primary|Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)|Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The four phases in the study are (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion. The scores documented here are the total OSBD-R scores.|Up to 10 minutes after the procedure completion||||units on a scale||Standard Deviation|Mean
1371593|NCT01548885|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose(BG) below 70 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number (190) of BG results was possible for each BGMS. Subjects provided 1,2,or 3 capillary samples, of which 190 samples were less than 70 mg/dL.|||percentage|Participants|95% Confidence Interval|Mean
1371594|NCT01548885|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number 388(393-3-2)BG results possible for each BGMS.Subjects provided 1,2,or 3 capillary samples-total 393 samples. 3 glycolyzed samples were not analyzed - glycolysis exceeded the protocol-defined time. All meter data for 2 glycolyzed samples were not evaluable (not analyzed)- their YSI results were less than the meter operating ranges.|||percentage|Participants|95% Confidence Interval|Mean
1371596|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)|% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.|Weeks 9 and 17|Intent to treat analysis|||percentage clinical responders||95% Confidence Interval|Number
1371597|NCT01548742|Secondary|Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up|The PHQ-9 is a valid and reliable measure of depression symptom severity. Score range from 0-27; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 5 or more points on the PHQ-9.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).|||units on a scale||95% Confidence Interval|Mean
1371598|NCT01548742|Secondary|PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up|The CAPS is a valid and reliable measure of PTSD symptom severity. Score range from 0-136; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the CAPS.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).|||units on a scale||95% Confidence Interval|Mean
1371599|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL|% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.|Weeks 9 and 17|Intent to treat analysis|||percentage clinical responders||95% Confidence Interval|Number
1371600|NCT01548742|Primary|PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up|The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.|Baseline, Weeks 3, 6, 9 and 17|Intent to treat population (all participants randomized to treatment).|||units on a scale||95% Confidence Interval|Mean
1371601|NCT01548638|Secondary|Subjective Symptoms (Nicotine Withdrawal)|"Subjects were asked to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The subjective symptoms listed above were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).~The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales."|Days 7, 14, 21, 28, 35, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
1371602|NCT01548638|Secondary|Subjective Symptoms (Negative Affect)|"Subjects were asked to complete the Positive and Negative Affect Scale (PANAS) to assess symptoms of negative affect (the positive affect scale was not administered). This 10-item scale assesses was assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).~The range of possible total scores on the PANAS negative affect scale is 10-50, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales within the negative affect scale of the PANAS."|Days 7, 14, 21, 28, 35, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
1371603|NCT01548638|Secondary|Side Effects of Galantamine|"Side effects of galantamine were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). A 37-item checklist of side effects based on the product insert (e.g., Nausea, Vomiting, Diarrhea, Loss of appetite, Stomach pain, Constipation, Gastroesophageal Reflux Problems (Heartburn)) was administered to participants at all study visits after the Intake. An open-ended side effects question was also be included.~Items were measured on a scale from 0 (None) to 3 (Severe).~The side effect summary score (total side effects averaged from the 37 item checklist) at each visit is reported below. Each score ranges from 0 (None) to 3 (Severe)."|Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
1371604|NCT01548638|Secondary|Subjective Symptoms (Smoking Urges)|"During each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). This measure is an index of urges to smoke, or cigarette craving. The subjective symptoms listed above will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).~The range of possible scores on the QSU-B is 10-70, with higher values indicating increased urges to smoke. This range of scores represents a total score; there are no subscales."|Days 7, 14, 21, 28, 35, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
1371605|NCT01548638|Secondary|Cognitive Performance: Working Memory Accuracy|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.~Number of correct responses (true positives) is described below.~The maximum number of correct responses is 60."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43||||correct responses||Standard Deviation|Mean
1371606|NCT01548638|Secondary|Cognitive Performance: Working Memory Reaction Time|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.~Median reaction time to correct responses is described below.~Typical responses range from 250 ms to 1500 ms."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43||||ms||Standard Deviation|Mean
1371607|NCT01548638|Primary|Number of Days of Abstinence During a 7-day Quit Attempt|Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.|Days 36-43; following a 5-week dose run-up||||days||Full Range|Mean
1371608|NCT01548573|Secondary|Overall Survival|To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy.|10 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 4 were not collected."||||||
1371609|NCT01548573|Secondary|Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.|To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches.|2 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 3 were not collected."||||||
1371610|NCT01548573|Primary|Identification of Drug Resistant Genes|To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation.|5 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 2 were not collected."||||||
1371611|NCT01548573|Primary|Event-Free Survival (EFS)|To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.|8 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 1 were not collected."||||||
1371612|NCT01548417|Secondary|Drinking|Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70.|2 weeks|Three randomized subjects who met exclusionary criteria were not included in the regression analysis for drinking: two subjects were excluded for unreliable reporting and one subject was excluded for being treatment seeking.|||alcoholic drinks per week||Standard Error|Mean
1371613|NCT01548417|Primary|Craving to Drink|Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.|1 week|1 participant who completed the study had missing VAS scores.|||units on a scale||Standard Error|Mean
1371614|NCT01548404|Secondary|Change From Baseline in 5-D Pruritus Scale at Week 12|The 5-D Pruritus Scale is a 1-page, 5-question tool used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; participants were to rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected. After the summation of individual score, the total score ranges from 5 (least affected) to 25 (most affected).|Baseline to Week 12|FAS population.|||units on a scale||Standard Deviation|Mean
1371615|NCT01548404|Secondary|Change From Baseline in Pruritus Numerical Rating Scale (NRS) to Week 12- LOCF|Pruritus NRS was an assessment tool that was used to report the intensity of a participant’s pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 – 10 [0 = no itch; 10 = worst itch imaginable]). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population. Number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1371616|NCT01548404|Secondary|Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 12- LOCF|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23–31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Units on a scale||Standard Deviation|Mean
1371617|NCT01548404|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Percentage of BSA||Standard Deviation|Mean
1371618|NCT01548404|Secondary|Percent Change From Baseline in IGA Score at Week 12- LOCF|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Percent change||Standard Deviation|Mean
1372769|NCT01536067|Secondary|Time to Progression||From start of treatment to disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1371619|NCT01548404|Secondary|Change From Baseline in EASI Score at Week 12- LOCF|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Units on a scale||Standard Deviation|Mean
1371620|NCT01548404|Secondary|Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 12. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Week 12|FAS population.|||Percentage of participants|||Number
1371621|NCT01548404|Secondary|"Percentage of Participants With Investigator’s Global Assessment (IGA) Score of 0 or 1 at Week 12- LOCF"|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Week 12|FAS population.|||percentage of participants|||Number
1371622|NCT01548404|Primary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF)|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|Full analysis set (FAS) population included all randomized participants who received at least one dose of study drug and had at least 1 post-baseline efficacy assessment.|||percent change||Standard Deviation|Mean
1371623|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Population with valid actigraphy data|||% (efficiency=% of time asleep)||90% Confidence Interval|Least Squares Mean
1371624|NCT01548287|Secondary|Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data|||Minutes||90% Confidence Interval|Least Squares Mean
1371625|NCT01548287|Secondary|Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data|||Minutes||90% Confidence Interval|Least Squares Mean
1371626|NCT01548287|Secondary|Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set|||Rank transformed duration (minutes)||90% Confidence Interval|Least Squares Mean
1371627|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set|||% change||90% Confidence Interval|Least Squares Mean
1371628|NCT01548287|Primary|Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.|Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.|Baseline and Week 4.|Primary analysis set|||Minutes||90% Confidence Interval|Least Squares Mean
1371629|NCT01548040|Other Pre-specified|Visual Analogue Scales (VAS)|Pain change score in VAS from baseline to week 6 post-surgery|1 wk pre-operatively,3,6,12 and 52 post operatively|||||||
1371630|NCT01548040|Other Pre-specified|Stair Climb Test|Change in scores of physical performance measures|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
1371631|NCT01548040|Other Pre-specified|Timed to Get up and go|Change in scores of physical performance measures|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
1371632|NCT01548040|Other Pre-specified|Range of Motion|Change in scores of functional and physical performance scores|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
1371633|NCT01548040|Other Pre-specified|Questionnaires|Change in scores in patient outcome measures, functional measures and physical performance measures|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
1371634|NCT01548040|Other Pre-specified|Physical Therapy Sessions|Change in patient functional measures and number of therapy sessions required.|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
1371635|NCT01548040|Secondary|Percentage of Patients With Positive PASS|To determine whether Kneehab XP leads to earlier recovery (measured at the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Patient Acceptable Symptom State (PASS) is a yes/no answer to a specifically stated question about the patients satisfaction with their state. For clarity, Positive PASS implies that the answer that is given is Positive i.e. Yes|measured at the 6 week post-operative time point||||% of participants|||Number
1371654|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371636|NCT01548040|Primary|Isometric Strength Test|To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured as the difference between the baseline time point and the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Isometric strength was measured using a Biodex Isokinetic Dynamometer machine on patients seated and secured to a chair and who performed 3 maximal voluntary contractions (MVC) for which the maximal torque is measured and a mean taken of 3 consecutive MVC's.|measured at the 6 week post-operative time point||||Newton-metres||Standard Deviation|Mean
1371637|NCT01547806|Secondary|Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product|Flow cytometry to detect tumor contamination.|Day 1 of apheresis|Because no data from any participant was sufficiently collected to assess tumor cell contamination, we were not able to determine the effect of plerixafor on this parameter.||||||
1371638|NCT01547806|Secondary|Degree of Tumor Cell Contamination in the Final Product|Flow cytometry to detect tumor contamination.|Day 1 of apheresis|No data from any participant was sufficiently collected to assess tumor cell contamination.||||||
1371639|NCT01547806|Secondary|Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)|Percentage of patents achieving collecting the minimum but not optimal CD34 cell number.|Day one of collection||||percentage of patients|||Number
1371640|NCT01547806|Secondary|Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg|Here is the percentage of patients that achieved or did not achieve 5 x 10^6 CD34 cells/kg in a single apheresis.|Through Day 2 of collection||||percentage of patients|||Number
1371641|NCT01547806|Secondary|Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)|Percentage of patients that required Plerixafor injection in addition to G-CSF mobilization or none at all|One week of mobilization therapy||||percentage of patients|||Number
1371642|NCT01547806|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|27 months and 27 days||||Participants|||Count of Participants
1371643|NCT01547806|Primary|Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)|The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.|Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of||||products|||Number
1371644|NCT01547806|Primary|25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)|||Number
1371645|NCT01547806|Primary|Range of Cluster of Differentiation 34 (CD34) Cells Collected|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)||Full Range|Median
1371646|NCT01547806|Primary|Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)||Standard Deviation|Median
1371647|NCT01547806|Primary|Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)||Standard Deviation|Mean
1371648|NCT01547806|Primary|Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||percentage of patients|||Number
1371649|NCT01547806|Primary|Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis|Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE^6/kg following apheresis.|Day 1 of apheresis||||percentage of patients|||Number
1371650|NCT01547728|Primary|Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration|Restored antithrombin level is defined as an activated clotting time > 480 seconds 3 minutes after the initial dose of 500 units of rhAT is administered. The percentage of patients who meet this criterion will be summarized using a point estimate and a 95% confidence interval.|3 minutes after the initial dose of rhAT, Day 1 of the study|The study was terminated because there were too many barriers to enroll participants.||||||
1371651|NCT01547715|Secondary|Number of Subjects With Unsolicited Adverse Events|The safety of one dose of MenACWY –CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.|Day 1 through day 29|The analysis was performed on the safety analysis dataset.|||participants|||Number
1371652|NCT01547715|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set.|||Participants|||Number
1371653|NCT01547715|Secondary|Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY – CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.|||Participants|||Number
1371655|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371656|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371657|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371658|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371659|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371660|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.|Day 29 ( ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371661|NCT01547715|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
1371662|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371663|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371664|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.|Day 29|Analysis was done on the FAS.|||Percentage||95% Confidence Interval|Number
1371665|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371666|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371667|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371668|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371669|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS|||Percentage of subjects||95% Confidence Interval|Number
1371670|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371671|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371672|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
1371673|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A.|Day 29 (1 month post vaccination)|Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.|||Percentages of subjects||95% Confidence Interval|Number
1371674|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 6|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 6|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
1371675|NCT01547598|Secondary|Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg|IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.|||percentage of participants|||Number
1371676|NCT01547598|Secondary|Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline|IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Baseline, Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.|||percentage of participants|||Number
1371677|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
1371678|NCT01547598|Primary|Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the modified Intent-to-treat (mITT) population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.|||mmHg||Standard Deviation|Mean
1371679|NCT01547390|Secondary|Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage|"Intrauterine growth restriction (IUGR) - estimated fetal weight less than 10th percentile early preeclampsia - preeclampsia delivered prior to 34 weeks severe preeclampsia - blood pressure greater then 160/110 gestational hypertension - hypertension without features of preeclampsia preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.~Statistical significance not reported due to the low recruitment and poor patient compliance."|within 3 months of delivery||||participants|||Number
1371680|NCT01547390|Primary|Number of Participants With Preeclampsia|Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).|within 3 months prior to delivery||||Participants|||Count of Participants
1371681|NCT01547299|Secondary|Number of Participants With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From baseline up to 210 days|All participants who received at least 1 partial dose of enzalutamide (safety population).|||participants|||Number
1371682|NCT01547299|Secondary|Change From Baseline in Serum Testosterone at Day 180|To determine serum hormone effects as measured by change in testosterone at baseline and at completion of therapy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a serum testosterone result at baseline and 180 days post baseline. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
1371683|NCT01547299|Secondary|Serum Testosterone: Day 180||Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a 180 days post baseline serum testosterone result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
1371684|NCT01547299|Secondary|Serum Testosterone: Baseline||Baseline|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline serum testosterone result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
1371685|NCT01547299|Secondary|Change From Baseline in Serum Dihydrotestosterone (DHT) at Day 180|To determine serum hormone effects as measured by change in DHT values from baseline to the completion of therapy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a serum DHT result at baseline and 180 days post baseline. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
1371686|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): Day 180||Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with 180 days post baseline serum DHT result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
1371688|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling as Measured by Intensity of Androgen Receptor Immunohistochemical (IHC) Staining|To determine the effects of triplet therapy and enzalutamide alone on androgen receptor signaling in prostatectomy specimens. Androgen receptor (AR) was a type of nuclear receptor that was activated by binding either of the androgenic hormones, testosterone, or dihydrotestosterone in the cytoplasm and then translocating into the nucleus. Androgen receptor (AR) signaling represented the major therapeutic target for treating metastatic prostate cancer. Assessment of androgen receptor signaling was measured by intensity of androgen receptor IHC staining and were graded as 0 (absent), 1 (weak), 2 (moderate) and 3 (strong). Percentage of participants within each grade are reported below.|Day 180|All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist.|||percentage of participants|||Number
1371689|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Mitotic Index|Assessment was performed to determine the effects of triplet therapy and enzalutamide alone on mitotic index. Mitotic index was defined as the ratio between the numbers of cells in a population undergoing mitosis to the number of cells in a population not undergoing mitosis in prostatectomy specimens.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||ratio||Standard Deviation|Mean
1371690|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Apoptosis|To determine the effects of triplet therapy and enzalutamide alone on apoptosis in prostatectomy specimens. Apoptosis was a process of biochemical events that lead to characteristic cell changes and death.|Day 180|Data for this outcome measure was not collected as assessment of apoptosis was not performed due to limited amounts of tissue samples available.||||||
1371691|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Testosterone|To determine pharmacodynamic effects as measured by the amount of tissue testosterone in prostatectomy specimens following radical prostatectomy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||picogram per milligram||Standard Deviation|Mean
1371692|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)|To determine pharmacodynamic effects as measured by the amount of tissue DHT in prostatectomy specimens following radical prostatectomy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||picogram per milligram||Standard Deviation|Mean
1371693|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Mental Component Summary|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The mental health domain score had 2 items scored on a scale of 1 to 5 where for 1 item 1=all of the time person felt calm and peaceful to 5=none of the time person felt calm and peaceful. The score ranged from 1 to 5, where higher scores meant worse mental status. For other item 1=all of the time person felt downhearted and blue to 5=none of the time person felt downhearted and blue. The score ranged from 1 to 5, where higher scores meant better mental status. Best change from baseline category in mental component summary ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371694|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Role-Emotional Domain Score|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The mental health domain score had 2 items scored on a scale of 1 to 5, where higher scores indicated worse mental status. The total score ranged from 1 to 10, where higher scores indicated worse mental status. Best change from baseline category in mental component summary ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371695|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Physical Functioning Domain Score|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The physical functioning domain score contained 2 items each scored on a scale of 1 to 5 where 1=excellent physical functioning to 5=poor physical functioning. Physical functioning domain total score ranged from 1 to 10, where higher scores indicated poor physical functioning. Best change from baseline category in physical functioning domain score ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371726|NCT01546922|Secondary|Change in Somatosensation After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Measures of somatosensation: the mechanical detection threshold, the mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, wind up ratio and the pressure pain threshold.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|||||||
1371696|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 General Health Domain Score|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The general health domain score contained 1 item scored on a scale of 1 to 5 where 1=excellent to 5=poor health, where higher score indicated worse health status. Best change from baseline category in general health domain score ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371697|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score|EPIC hormonal bother subscale score was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. EPIC hormonal bother subscale was a component of hormonal domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing less hormonal bothering. Best change from baseline category in EPIC hormonal bother subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371698|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score|EPIC hormonal function subscale score was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. EPIC hormonal function subscale was a component of hormonal domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. Best change from baseline category in EPIC hormonal function subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371699|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score|EPIC Hormonal Domain was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. Best change from baseline category in EPIC hormonal domain summary score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371700|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score|EPIC sexual bother subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual bother subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing less sexual bother and difficulty. Best change from baseline category in EPIC sexual bother subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371701|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score|EPIC sexual function subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual function subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function. Best change from baseline category in EPIC sexual function subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1372770|NCT01536067|Secondary|Frequency of PR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1371702|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score|EPIC sexual domain was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. Sexual domain summary score was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function and satisfaction. Best change from baseline category in EPIC sexual domain summary score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
1371703|NCT01547299|Secondary|Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA)|To determine the effects on PSA as measured by the percentage of participants with PSA less than (<) 0.2 nanogram per milliliter (ng/mL), and a 50 percent (%) and 90% decrease in PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland.|Day 195|All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA.|||percentage of participants||95% Confidence Interval|Number
1371704|NCT01547299|Secondary|Time to Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the time to the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant’s lowest observed post baseline PSA value.|Day 195|All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA.|||days||Full Range|Median
1371705|NCT01547299|Secondary|Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant’s lowest observed post baseline PSA value.|Day 195|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA. Here, N signifies number of participants evaluable for this specified outcome measure."|||microgram per liter (mcg/L)||Full Range|Median
1371706|NCT01547299|Secondary|Percentage of Participants With Positive Lymph Nodes|To determine the percentage of participants with positive lymph nodes at prostatectomy as assessed by the local and central pathologist. Lymph nodes were small clumps of immune cells that act as filters for the lymphatic system. Lymph nodes with cancer cells in them were called positive lymph nodes.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
1371707|NCT01547299|Secondary|Percentage of Participants With Positive Seminal Vesicles|To determine the percentage of participants with positive seminal vesicles at prostatectomy as assessed by the local and central pathologist. Seminal vesicles or seminal glands, were defined as a pair of simple tubular glands located within the pelvis. They secrete fluid that partly composes the semen. Seminal vesicles with cancer cells in them were called positive seminal vesicles.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
1371708|NCT01547299|Secondary|Percentage of Participants With Extracapsular Extension: Central Review|To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the central pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.|Day 180|"All participants randomly assigned to study treatment with a prostatectomy sample evaluated by the central pathologist. One participant in the Enzalutamide treatment arm was excluded from the analysis because the result reported by the central lab was indeterminate. Here, N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
1371709|NCT01547299|Secondary|Percentage of Participants With Extracapsular Extension: Local Review|To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the local pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
1371710|NCT01547299|Secondary|Percentage of Participants With Positive Surgical Margins|To determine the percentage of participants with positive surgical margins at prostatectomy as assessed by the local and central pathologist. Surgical margin, also known as tumor free margin referred to the visible normal tissue or skin margin that was removed with the surgical excision of a tumor, growth, or malignancy. The margin was described as positive when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
1371727|NCT01546922|Secondary|Change in Metabolic Profile After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Cardiovascular and metabolic risk factors, (pituitary) hormones and bone markers.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|||||||
1372771|NCT01536067|Secondary|Frequency of Very Good Partial Response (VGPR)||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1371711|NCT01547299|Primary|Pathologic Complete Response Rate|Pathologic complete response rate was defined as percentage of participants with pathologic complete response. Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 180 days prior to prostatectomy in participants with localized prostate cancer. Pathologic complete response was defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as assessed by the local and central pathologist.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
1371712|NCT01547286|Secondary|Coefficient of Variation Squared of Perfusion|Coefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.|7 hours after allergen administration||||unitless||Standard Deviation|Mean
1371713|NCT01547286|Secondary|Coefficient of Variation Squared of Perfusion|Coefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.|3 hours after allergen administration||||unitless||Standard Deviation|Mean
1371714|NCT01547286|Primary|Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside|Blood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).|7 hours after allergen administration||||percentage||Standard Deviation|Mean
1371715|NCT01547286|Primary|Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside|Blood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).|3 hours after allergen administration||||percentage||Standard Deviation|Mean
1371716|NCT01547247|Secondary|Success Rate of Minimal Sedation Colonoscopy|A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.|3 months||||percentage of all subjects in arm|||Number
1371717|NCT01547247|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months|||||||
1371718|NCT01547247|Primary|Cecal Intubation Time|The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.|3 months|Statistical power was calculated for the primary endpoint. A sample size of 93 subjects per arm was calculated using two-tailed alfa 0.05, beta 0.2, assuming that difference 20 % in intubation times would have been clinically relevant.|||minutes||95% Confidence Interval|Number
1371719|NCT01547130|Secondary|Total Preparation Time|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.|Upto 24 weeks|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.|||hours||Full Range|Mean
1371720|NCT01547130|Secondary|Patient-reported Adverse Events.|Patients from both groups reported adverse events in a symptom questionnaire.|Upto 24 weeks|Patients from both groups reported adverse events in a symptom questionnaire.|||participants|||Number
1371721|NCT01547130|Secondary|Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.|"Subjects rated the SCC as Willingness to repeat the same prep in future"|Upto 24 weeks|Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale.|||participants|||Number
1371722|NCT01547130|Secondary|Palatability of Bowel Prep|"Patients completed a symptom questionnaire where they rated solution palatability of their assigned prep on a 1-5 Likert scale. A rating of more than 3 was considered as Palatable."|Upto 24 weeks|All subjects enrolled and completed the bowel preparation. .|||participants|||Number
1371723|NCT01547130|Primary|Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy|The primary endpoint was the “success” rate of the preparations. Preparation efficacy was evaluated by a single, blinded endoscopist (V.A.), who performed all of the colonoscopies. The evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon and cecum) on the 5 point Arya Bowel Prep Scale (ABPS). Aggregating the segmental scores resulted in overall scores. Grade A was defined as a total overall score of 19–24, grade B as a score of 13–18, grade C as a score of 7–12, and grade D as a score of 0–6. Grade A or B preparation was considered “successes”, while grade C or D was considered “failures.” To assess the reliability of ABPS, we trained 4 gastroenterologists and 3 fellows.|Within 48 hours of bowel preparation|The non-inferiority margin was set at -15%. This means the intervention will be considered non-inferior if the difference in success rates is less than 15%. The study was designed to have 90% power to establish non-inferiority when the two treatment groups are equivalent using a one-tailed test at the 5% significance level.|||Score||Standard Deviation|Mean
1371724|NCT01547000|Primary|Yale Global Tic Severity Scale (YGTSS)|The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.|8 weeks||||units on a scale||Standard Deviation|Mean
1371725|NCT01546922|Secondary|Change in Perceived Common Somatic Complaints After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|The patients report common somatic complaints by filling in structured daily diaries.|during treatment period 1 (that is from week 1 to week 10 from baseline) and during treatment period 2 (that is from week 11 to week 20 from baseline).|||||||
1372772|NCT01536067|Secondary|Frequency of Near (n)CR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1371728|NCT01546922|Secondary|Change in Quality of Life After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Quality of life questionnaires have to be filled in by the participant at his/her home place and have to be returned by post.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|||||||
1371729|NCT01546922|Primary|Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|"Cognitive domains to be tested: memory, executive functioning, attention and social cognition.~The psychological tests consist of oral and written questions or computer tasks.~Data is given as Z-scores based on normative data. Higher Z-scores represent a better performance."|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|The participants completing both study periods were analyzed|||Z-scores based on normative data.||Standard Deviation|Mean
1371730|NCT01546883|Primary|Percentage of Fibrosis|We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.|MRI at baseline and MRI at 12 months post-enrollment|Data were not collected for the analysis population and therefore could not be summarized to include in this report.||||||
1371731|NCT01546688|Secondary|Percentage of Responders During Last 28 Days of Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits.|Baseline and Month 4|Intent-to-Treat Population. Percentages are based on the number of subjects present in the Maintenance Phase.|||Percentage of Participants|||Number
1371732|NCT01546688|Secondary|Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.|Baseline and Month 4|Intent-to-Treat Population.|||Percent Change||Full Range|Median
1371733|NCT01546688|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period|The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population|||Scores on a Scale||Standard Deviation|Mean
1371734|NCT01546688|Primary|Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period|The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication.|||Seconds||Standard Deviation|Mean
1371735|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale|The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|After 4 weeks of home use (2 weeks for each socket style)||||units on a scale|||Number
1371736|NCT01546675|Primary|Degrees of Shoulder Displacement Within the Prosthetic Socket|A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)||||degrees|||Number
1371737|NCT01546675|Primary|Degrees of Shoulder Internal Rotation Within the Prosthetic Socket|Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)||||degrees|||Number
1371738|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale|The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|after 2 weeks of home use of each socket type||||units on a scale|||Number
1371739|NCT01546675|Secondary|Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)|This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.|After 4 weeks of home use (2 weeks for each socket style)||||units on a scale|||Number
1371740|NCT01546675|Primary|Degrees of Shoulder Abduction Within the Prosthetic Socket|Shoulder abduction was performed to the subject’s maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|One male and one female with traumatic amputation at the transhumeral level.|||degrees|||Number
1372773|NCT01536067|Secondary|Frequency of Complete Remission (CR)||Every 28 days|||||||
1371741|NCT01546649|Secondary|QT Interval Measured by 12-lead Electrocardiogram (ECG)|12-lead electrocardiography measurement was performed in supine position after 5 minutes at rest. Each measurement was recorded continuously for 10 seconds at the recording speed of 25 millimeter/second (mm/second).|Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337|Safety evaluation was conducted in the safety analysis set (SAS). Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||millisecond (msec)||Standard Deviation|Mean
1371742|NCT01546649|Secondary|Serum Unchanged TAP-144 Level|This measure indicates the unchanged TAP-144 level in serum.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309 and 337|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||nanogram per deciliter (ng/dL)||Standard Deviation|Mean
1371743|NCT01546649|Secondary|Distant Disease Free Survival (DDFS) Rate at Week 96|DDFS is defined as time from randomization to earliest day of onset the events, distant recurrence, secondary cancer [including breast cancer in the contralateral breast] and death. DDFS at week 96 was defined as the percentage calculated with Kaplan-Meier method, of participants did not experience any events at week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.|||percentage of participants|||Number
1371744|NCT01546649|Secondary|Disease Free Survival (DFS) Rate at Week 96|DFS is defined as time from randomization to earliest day of onset the events, recurrence [including recurrence in the ipsilateral breast], secondary cancer [including breast cancer in the contralateral breast] and death. DFS at Week 96 was defined as the percentage, calculated with Kaplan-Meier method, of participants did not experience any events at Week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.|||percentage of participants|||Number
1371745|NCT01546649|Secondary|Concentration of Follicle Stimulating Hormone (FSH)|This measure indicates serum FSH concentration at baseline and post-baseline time points.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||mIU/mL||Full Range|Median
1371746|NCT01546649|Secondary|Concentration of Serum Luteinizing Hormone (LH)|This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||mIU/mL||Full Range|Median
1371747|NCT01546649|Secondary|Concentration of Serum E2|The measure indicates serum E2 concentration at baseline and post-baseline time points.|Baseline, Hour (hr) 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||pg/mL||Full Range|Median
1371748|NCT01546649|Primary|Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48|Comparison of both the treatment groups was done by assessing the suppressive effect on serum E2 concentration maintained at menopausal level (=<30pg/mL). Suppression rate was calculated as proportion of participants maintained at menopausal level.|Week 4 up to Week 48|Full analysis set (FAS) included all randomized participants who had received at least a single dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1371749|NCT01546636|Secondary|Postanesthesia Care Unit Length of Stay (Total Time)||Approximately 5 hours||||minutes||Full Range|Median
1371750|NCT01546636|Secondary|Number of Patients Experiencing Nausea and Vomiting|Assessed by recovery nurses|Postanesthesia care unit-first 2 hours||||participants|||Number
1371751|NCT01546636|Primary|Incidence of Cerebral Desaturation Events|Cerebral desaturation events were measured with near-infrared spectroscopy|Intraoperative-first 2 hours||||number of events|||Number
1371752|NCT01546623|Secondary|12-lead ECG||At 1 hour, week 24, and week 48 after administration|Safety evaluation was conducted in the safety analysis set (SAS), which includes all 160 patients who received the study drug [TAP-144-SR (&M) group: 81 patients, TAP-144-SR (3M) group: 79 patients|||msec||Standard Deviation|Mean
1371753|NCT01546623|Secondary|Serum Unchanged TAP-144 Level||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||ng/dL||Standard Deviation|Mean
1371754|NCT01546623|Secondary|Bone Lesion Response|Partially revised assessment based on the “criteria for therapeutic effect” from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression|At Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||Percentage of participants|||Number
1371755|NCT01546623|Secondary|Soft Tissue Response|Assessment in accordance with the “criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||Percentage of participants|||Number
1372241|NCT01542372|Secondary|Change in the SF-12 at 12 Weeks in Step II|A measure of severity of self-perceived functioning. Total score ranges from 0 to 100, with a higher score indicating better self-perceived functioning. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1371756|NCT01546623|Secondary|Percentage of Participants With Progression by PSA (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants|Participants||Number
1371757|NCT01546623|Secondary|The Maximum Rate of Change in PSA Suppression (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percent change||Full Range|Median
1371758|NCT01546623|Secondary|Time Course of Change Rate in Serum PSA (FAS)|Evaluation according to the “Criteria for therapeutic effect” from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen [PSA])|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percent change||Full Range|Median
1371759|NCT01546623|Secondary|Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||mIU/mL||Full Range|Median
1371760|NCT01546623|Secondary|Time Course of Changes in Serum Luteinizing Hormone (LH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||mIU/mL|Participants|Full Range|Median
1371761|NCT01546623|Secondary|Time Course of Changes in Serum Testosterone||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||ng/dL||Full Range|Median
1371762|NCT01546623|Primary|The Rate of Suppression of Serum Testosterone to Castrate Level|Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)|From the start of study drug administration through Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of study drug) was used.|||Participants|||Number
1371763|NCT01546519|Secondary|Apparent Non-renal Clearance (CLNR/F) of Vismodegib|Apparent Non-Renal Clearance (CLNR) describes the removal of vismodegib by organs other than the kidneys. This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
1371764|NCT01546519|Secondary|Apparent Clearance (CL/F) of Vismodegib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr). This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
1371765|NCT01546519|Secondary|Minimum Plasma Concentration (Cmin) of Vismodegib|Cmin is defined as the minimum observed plasma concentration of Vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
1371766|NCT01546519|Secondary|Time to Maximum Plasma Concentration (Tmax) of Vismodegib|Tmax is the time to reach maximum plasma concentration of vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
1371767|NCT01546519|Secondary|Amount of Vismodegib Excreted Into Urine in 24 Hours (Ae0-24hr)|The amount of total vismodegib excreted in urine over a 24-hr total interval (Ae0-24hr) was estimated.|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.|||milligrams/24 hour||Standard Deviation|Mean
1371768|NCT01546519|Secondary|Renal Clearance of Vismodegib|Renal clearance (CLR) is defined as the apparent total clearance of the drug from plasma after oral administration.|0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.|||Liter/hour||Standard Deviation|Mean
1371769|NCT01546519|Secondary|The Percentage of Dose of Vismodegib in 24-hour Total Urine|The percentage of dose vismodegib excreted in urine over a 24-hr total interval was estimated|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.|||% Dose Excreted in 24 hr||Standard Deviation|Mean
1371831|NCT01546038|Secondary|AUCtau of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. AUCtau values of daunorubicin and daunorubicinol are reported.|Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371770|NCT01546519|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-24hours]) Following Multiple Doses of Vismodegib|The steady state pharmacokinetic profile following oral administration of multiple doses of vismodegib included determining the area under the curve over the dosing interval (AUC[0-24 hours]). The AUC[0-24 hrs]) was determined by standard non-compartmental analysis using WinNonlin. Blood samples were collected at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8 to estimate AUC(0-24 hrs).|Day 1, 2, 4 and 0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples|||Micromolar*hour||Standard Deviation|Mean
1371771|NCT01546519|Primary|Maximum Observed Plasma Concentration and Concentration at Steady-state Following Multiple Doses of Vismodegib|Maximum observed plasma Concentration (Cmax) & Concentration at steady-state (Css) following multiple doses of vismodegib (150 mg QD) were analyzed. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated. Blood samples for assessing Cmax and Css for analysis were collected following multiple oral doses of vismodegib at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8. From the plasma concentration-time curve, the PK parameter Cmax and Css were determined by standard non-compartmental analysis using WinNonlin|Day 1,2,4 and 0, 0.5, 1, 2, 4, 8 and 24 hours post dose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples|||micromolar||Standard Deviation|Mean
1371772|NCT01546454|Primary|Total to HDL Cholesterol Ratio||Entire Study||||Total to HDL Cholesterol Ratio||95% Confidence Interval|Mean
1371773|NCT01546402|Secondary|Change in the Visual Acuity|Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best|Difference in number of letters read (6 months minus baseline)||||Number of letters on ETDRS scale||Standard Deviation|Mean
1371774|NCT01546402|Primary|Change in the Central Macular Thickness|The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.|Baseline and 6 MONTHS||||Microns||Standard Deviation|Mean
1371775|NCT01546285|Primary|Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements|The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.|End of each blood pressure reading|66 subjects were enrolled. 64 subjects contributed data to the study. Subject 058 had a lateral difference of the reference diastolic blood pressure more than 10mmHg, and NIBP data was excluded from final analysis as specified in AAMI SP-10 standard. And Subject 046 had circulation issues and no data was collected.|||mmHg||Standard Deviation|Mean
1371776|NCT01546207|Secondary|Signal-Average ECG|Relationship between change in pre/post saECG and success of the step-wise ablation strategy|baseline and post-op day one after procedure|||||||
1371777|NCT01546207|Secondary|Procedural Safety|2) Procedural safety as defined by the number of complication within 1week associated with the procedure.|1 week post-op|||||||
1371778|NCT01546207|Secondary|ICD Interrogation|Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.|baseline and 6 months follow-up|||||||
1371779|NCT01546207|Primary|Catheter Ablation|The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia|at time of catheter ablation procedure (intraoperative)|||||||
1371780|NCT01546194|Primary|Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).|Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.|First postoperative day||||units on a scale||Full Range|Median
1371781|NCT01546168|Secondary|Swallowing Impairment Score|Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).|during AF ablation procedure (intraoperative)|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||units on a scale||Full Range|Mean
1371782|NCT01546168|Secondary|Temperature|Extent of temperature rise on the temperature monitoring probe|during AF ablation procedure (intraoperative)|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||Celsius||Standard Deviation|Mean
1371783|NCT01546168|Secondary|Procedure Time|Procedure time and fluoroscopic imaging with barium contrast time|day 1, duration ofAF ablation procedure|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||minutes||Standard Deviation|Mean
1371784|NCT01546168|Primary|Number of Participants With Presence of Esophageal Injury|The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.|within 1 week of AF ablation procedure|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||Participants|||Count of Participants
1371785|NCT01546155|Primary|PET/MRI Brain Activation|"Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure.~The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change."|day one||||percentage BOLD signal change||Standard Deviation|Mean
1371832|NCT01546038|Secondary|Tmax of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. Tmax values of daunorubicin and daunorubicinol are reported.|Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||Hours||Full Range|Median
1371786|NCT01546142|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||units on a scale||Standard Deviation|Mean
1371787|NCT01546142|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.|||percentage of participants|||Number
1371788|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
1371789|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
1371790|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs Categorized by Seriousness at Phase 2 Fit and Unfit|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. An serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.|1 year|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
1371791|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs at Phase 2 Fit and Unfit (Treatment-related)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. Treatment-related AEs were AEs related to glasdegib and/or backbone chemotherapy. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|1 year|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
1371792|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs at Phase 2 Fit and Unfit (All Causality)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|1 year|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
1371793|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs Categorized by Seriousness at Phase 1B|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. An serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.|1 year|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
1371794|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs at Phase 1B (Treatment-related)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. Treatment-related AEs were AEs related to glasdegib and/or backbone chemotherapy. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|1 year|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
1371795|NCT01546038|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs) at Phase 1B (All Causality)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|1 year|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
1371796|NCT01546038|Secondary|Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria at Phase 2 Fit and Unfit|Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula). Number of participants with QTcF meeting the following criteria is presented:QTcF interval:<450 msec; QTcF interval: 450 to <480 msec; QTcF interval: 480 to <500 msec; QTcF interval >=500 msec; QTcF interval increase from baseline: <30 msec; QTcF interval increase from baseline: 30 to <60 msec; QTcF interval increase from baseline >=60 msec. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.|1 year|QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.|||Participants|||Number
1371797|NCT01546038|Secondary|Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria at Phase 1B|Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula). Number of participants with QTcF meeting the following criteria is presented: QTcF interval:<450 msec; QTcF interval: 450 to <480 msec; QTcF interval: 480 to <500 msec; QTcF interval >=500 msec; QTcF interval increase from baseline: <30 msec; QTcF interval increase from baseline: 30 to <60 msec; QTcF interval increase from baseline >=60 msec. Arms in the time frame description are defined as: Arm A, Glasdegib +LDAC; Arm B, Glasdegib + Decitabine; Arm C, Glasdegib + Cytarabine/Daunorubicin. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.|1 year|QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.|||Participants|||Number
1371798|NCT01546038|Secondary|Ratios of mRNA Levels Associated With Best Overall Response at Phase 2 Unfit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Ratios of mRNA level to baseline showing statistically significant correlation with clinical response are reported. Ratios of mRNA levels to baseline statistically significant associated with best overall response was only seen for MYCN (Neuroblastoma Myc oncogene) at Cycle 1/Day 1.|Baseline (Cycle 1/Day 1 pre-dose); Cycle 1/Day 1, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
1371799|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline Associated With Best Overall Response at Phase 2 Fit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Ratios of mRNA level to baseline showing statistically significant correlation with clinical response are reported.|Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
1371800|NCT01546038|Secondary|Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Unfit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Baseline mRNA level showing statistically significant correlation with clinical response are reported. FOXM1: Forkhead box M1; PTCH1: Patched 1.|Baseline (Cycle 1/Day 1 pre-dose)|PD analysis set:all enrolled participants in Phase 2 Unfit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||Normalized expression units||Full Range|Median
1371833|NCT01546038|Secondary|Cmax of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. Cmax values of daunorubicin and daunorubicinol are reported.|Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3|PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371801|NCT01546038|Secondary|Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Fit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Baseline mRNA level showing statistically significant correlation with clinical response are reported. Baseline mRNA levels statistically significant associated with best overall response was only seen for CCND2 (G1/S-Specific Cyclin D2).|Baseline (Induction Cycle 1/Day -3 pre-dose)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||Normalized expression units||Full Range|Median
1371802|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline at Phase 2 Unfit - End of Treatment|Whole blood mRNA analyses were performed on 21 mRNA candidates. Only the analytes showing statistically significant change from baseline are reported here.|Baseline (Cycle 1/Day 1 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set:all enrolled participants in Phase 2 Unfit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
1371803|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline at Phase 2 Fit - End of Treatment|Whole blood mRNA analyses were performed on 21 mRNA candidates. Selected values showing statistically significant differences compared with baseline are reported here. CCND2:G1/S-Specific Cyclin D2; MSI2: Musashi RNA Binding Protein 2; PTCH2: Patched 2.|Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
1371804|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline at Phase 2 Fit - Induction Cycle 1/Day 3|Whole blood mRNA analyses were performed on 21 mRNA candidates. Values showing statistically significant, ≥2-fold differences compared with baseline are reported here. CDKN1A: cyclin-dependent kinase inhibitor 1A; SMO: mRNA encoding the glasdegib target Smoothened; PTCH2: Patched 2; MYCN: Neuroblastoma Myc oncogene.|Baseline (Induction Cycle 1/Day -3 pre-dose); Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
1371805|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - End of Treatment|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371806|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - Cycle 1/Day 1|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.|Cycle 1/Day 1, 1 Hour Post-dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371807|NCT01546038|Secondary|Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.|Baseline (Cycle 1/Day 1 pre-dose)|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371808|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant differences compared with baseline are reported here. ITAC (Interferon-inducible T-cell α chemoattractant) level in LDAC alone arm at Cycle 1/Day 10 exhibited non-significant change from baseline but similar trends as in Glasdegib 100 mg+LDAC arm.|Cycle 1/Day 10, Pre-dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371809|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 1|Serum levels were determined for 38 circulating proteins. Selected value showing statistically significant difference compared with baseline is reported here.|Cycle 1/Day 1, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371867|NCT01545843|Primary|Hamilton Rating Scale for Depression-17 Item Minus Sleep Items|Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.|Post-treatment (8 weeks)||||units on a scale||Standard Deviation|Mean
1371810|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - End of Treatment|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.|End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371811|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - Induction Cycle 1/Day 10|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|Induction Cycle 1/Day 10, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Mean
1371812|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - Induction Cycle 1/Day 3|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Mean
1371813|NCT01546038|Secondary|Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|Baseline (Induction Cycle 1/Day -3 pre-dose)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371814|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - End of Treatment|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371815|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Consolidation Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Consolidation Cycle 1/Day 10, Pre-dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371816|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Consolidation Cycle 1/Day 1|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Consolidation Cycle 1/Day 1, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371817|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Induction Cycle 1/Day 10, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371818|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction Cycle 1/Day 3|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371819|NCT01546038|Secondary|Number of Participants With Disease-related Gene Mutations at Phase 2 Fit and Unfit|Peripheral blood and bone marrow aspirate were collected for baseline mutational analyses. Genetic abnormalities frequently associated with AML were analyzed. These genetic abnormalities included known mutations in the genes NPM1, CEBPA, FLT3, RUNX1, IDH1, IDH2, KIT, K Ras, N Ras and WT1. Additional genes with mutations known to be associated with AML and MDS such as TET2 and DNMT3A were also evaluated.|Baseline (Induction Cycle 1/Day -3 pre-dose for Phase 2 Fit; Cycle 1/Day 1 pre-dose for Phase 2 Unfit)|PD analysis set: all enrolled participants in the Phase 2 Fit and Unfit portion who received at least 1 dose of glasdegib; responders and non-responders in each arm with at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||Participants|||Number
1371820|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B - Induction Cycle 1/Day 3|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported. Post-baseline levels statistically significant associated with best overall response was only seen for SDF-1 (Stromal cell-derived factor 1) at Induction Cycle 1/Day 3.|Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371821|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B - Induction Cycle 1/Lead-In|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported. Post-baseline levels statistically significant associated with best overall response was only seen for MMP-3 (Matrix metalloproteinase-3) at Induction Cycle 1/Lead-in.|Induction Cycle 1/Lead-in, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||ng/mL||Full Range|Median
1371822|NCT01546038|Secondary|Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response in Arm C are reported. Baseline levels statistically associated with best overall response was only seen in SDF-1 (stromal cell-derived factor 1) in glasdegib+cytarabine/daunorubicin arm.|Baseline (Cycle 1/Day 1 pre-dose for Glasdegib + LDAC and Glasdegib + Decitabine Arms; Induction Cycle 1/Day -3 pre-dose for Glasdegib +Cytarabine/Daunorubicin Arm)|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371823|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here.|Induction Cycle 1/Day 10, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371824|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 3|Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here. Statistically significant, >=2-fold baseline difference was only seen for MMP-3 (Matrix metalloproteinase-3) at Induction Cycle 1/Day 3.|Induction Cycle 1/Day 3, 1 Hour Post dose|Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371825|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 1B - Baseline|Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here.|Baseline (Induction Cycle 1/Day -3 pre-dose)|Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
1371826|NCT01546038|Secondary|Number of Participants With Disease-related Gene Mutations at Phase 1B|Peripheral blood and bone marrow aspirate were collected for baseline mutational analyses. Genetic abnormalities frequently associated with AML were analyzed. These genetic abnormalities included known mutations in the genes NPM1, CEBPA, FLT3, RUNX1, IDH1, IDH2, KIT, K Ras, N Ras and WT1. Additional genes with mutations known to be associated with AML and MDS such as TET2 and DNMT3A were also evaluated.|Baseline (Cycle 1/Day 1 pre-dose for Glasdegib + LDAC and Glasdegib + Decitabine Arms; Induction Cycle 1/Day -3 pre-dose for Glasdegib +Cytarabine/Daunorubicin Arm)|Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib; responders and non-responders in each arm with at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||Participants|||Number
1371827|NCT01546038|Secondary|AUCtau of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/Day 10||Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371828|NCT01546038|Secondary|Tmax of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/Day 10||Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||Hours||Full Range|Median
1371829|NCT01546038|Secondary|Cmax of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/Day 10||Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371830|NCT01546038|Secondary|Pre-dose Plasma Concentration (Ctrough) of Glasdegib in Phase 2 Fit on Induction Cycle 1/Day 10||Pre-dose, 1 and 4 hours post-dose on Induction Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371834|NCT01546038|Secondary|AUCtau of Cytarabine and Ara-U in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, levels of both cytarabine and Ara-U were reported.|Pre-dose, 6 and 24 hours post start of cytarabine infusion on Induction Cycle 1/Day 3|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371835|NCT01546038|Secondary|AUCinf of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2||Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371836|NCT01546038|Secondary|Tmax of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2||Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||Hours||Full Range|Median
1371837|NCT01546038|Secondary|Cmax of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2||Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2|PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371838|NCT01546038|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) levels of both LDAC and Ara-U were reported.|Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371839|NCT01546038|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to Infinity (AUCinf) of LDAC in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10||Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371840|NCT01546038|Secondary|Tmax of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, Tmax levels of both LDAC and Ara-U were reported.|Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||Hours||Full Range|Median
1371841|NCT01546038|Secondary|Cmax of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, Cmax levels of both LDAC and Ara-U were reported.|Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371842|NCT01546038|Secondary|AUCtau of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10||Pre-dose, 0.5, 1, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371843|NCT01546038|Secondary|Tmax of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10||Pre-dose, 0.5, 1, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||Hours||Full Range|Median
1371844|NCT01546038|Secondary|Cmax of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10||Pre-dose, 0.5, 1, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371845|NCT01546038|Secondary|AUCtau of Glasdegib in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 10 and Cycle 2/Day 1||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10; pre-dose, 0.5, 1, 2, 6 and 24 hours post-dose on Cycle 2/Day 1|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371846|NCT01546038|Secondary|Tmax of Glasdegib in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 10 and Cycle 2/Day 1||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10; pre-dose, 0.5, 1, 2, 6 and 24 hours post-dose on Cycle 2/Day 1|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||Hours||Full Range|Median
1372282|NCT01541865|Secondary|Chronic Symptomatic Orthostatic Hypotension||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||participants|||Number
1371847|NCT01546038|Secondary|Cmax of Glasdegib in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 10 and Cycle 2/Day 1||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10; pre-dose, 0.5, 1, 2, 6 and 24 hours post-dose on Cycle 2/Day 1|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371848|NCT01546038|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to Dosing Interval (AUCtau) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1371849|NCT01546038|Secondary|Time to Cmax (Tmax) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||Hours||Full Range|Median
1371850|NCT01546038|Secondary|Maximum Observed Plasma Concentration (Cmax) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1371851|NCT01546038|Secondary|Percentage of Participants With Disease-specific Efficacy for Myelodysplastic Syndrome (MDS) at Phase 2 Fit and Unfit|For all MDS participants, disease specific efficacy measures included: CRi (bone marrow showing <5% myeloblasts with platelets <100,000/mcL or neutrophils <1000/mcL, including confirmed and unconfirmed responses); PR (repeat bone marrow myeloblasts showing decreased by >= 50% decrease but still >5%, peripheral blood showing neutrophils >= 1,000/mcL, platelets >= 100,000/mcL and Hgb>=11g/dL; including confirmed and unconfirmed responses); SD (including confirmed and unconfirmed responses, failure to achieve PR and no evidence of progression for >8 weeks); marrow complete response (mCR) (bone marrow showing <=5% myeloblasts and decreased by >= 50%), partial cytogenetic response (>=50% reduction of chromosomal abnormality) and complete cytogenetic response (CRc) (disappearance of chromosomal abnormality with no appearance of now ones).|1 year|MDS participants in the Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication, and all randomized participants of Phase 2 Unfit arm.|||Percentage of participants||80% Confidence Interval|Number
1371852|NCT01546038|Secondary|Percentage of Participants With Disease-specific Efficacy for Acute Myeloid Leukemia (AML) at Phase 2 Fit and Unfit|AML participants,disease specific efficacy measures included:CRi;Morphologic Leukemia Free State(MLFS)(bone marrow<5%myeloblasts with spicules and no blasts with auer rods,neutrophils<1000/mcL and platelets<100,000/mcL);partial remission(PR)(bone marrow myeloblasts decrease to 5–25&>=50%decrease from start, neutrophils>=1000/mcL, platelets>=100,000/mcL);PR with incomplete blood count recovery(PRi)(bone marrow myeloblasts decrease to 5–25&>=50%decrease from start,neutrophils<1000/mcL or platelets<100,000/mcL);minor response(MR)(bone marrow myeloblasts decrease to>=25% from start);stable disease(SD)(bone marrow myeloblasts stable+/-25% from screening value);cytogenetic complete response(CRc)(bone marrow<5%myeloblasts, neutrophils>1000/mcL, platelets>100,000/mcL and normal cytogenetics),molecular complete response(CRm)(bone marrow<5%myeloblasts, neutrophils>1000/mcL, platelets>100,000/mcL and molecular-negative).|1 year|AML participants in the Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication, and all randomized participants of Phase 2 Unfit arm.|||Percentage of participants||80% Confidence Interval|Number
1371853|NCT01546038|Secondary|Percentage of Participants With Complete Response (CR) at Phase 2 Unfit|For AML participants:CR were those with repeat bone marrow showing <5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils>=1000/mcL and platelets>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing <=5% myeloblasts, peripheral blood showing neutrophils>=1000/mcL, platelets>=100,000/mcL, 0% blast and hemoglobin (Hgb)>= 11 g/dL, normal maturation of all cell lines.|1 year|Full analysis set: all randomized participants of Phase 2 Unfit arm.|||Percentage of participants||80% Confidence Interval|Number
1371854|NCT01546038|Secondary|Percentage of Participants With CR / Complete Response With Incomplete Blood Count Recovery (CRi) at Phase 1B|For AML participants:CR were those with repeat bone marrow showing <5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils>=1000/mcL and platelets>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing <=5% myeloblasts, peripheral blood showing neutrophils>=1000/mcL, platelets>=100,000/mcL, 0% blast and hemoglobin (Hgb)>= 11 g/dL, normal maturation of all cell lines.For AML and MDS participants, complete response with incomplete blood count recovery(CRi)were those with repeat bone marrow showing <5% myeloblasts with either platelets or neutrophils not recovered (platelets <100,000/mcL or neutrophils <1000/mcL).|1 year|Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.|||Percentage of participants||80% Confidence Interval|Number
1371855|NCT01546038|Secondary|Overall Survival (OS) at Phase 2 Fit|OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from each participant’s first dose.|First dose to Follow-up (4 years)|Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication.|||Months||80% Confidence Interval|Median
1371856|NCT01546038|Secondary|Overall Survival (OS) at Phase 1B|OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from each participant’s first dose.|First dose to Follow-up (4 years)|Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.|||Months||80% Confidence Interval|Median
1371857|NCT01546038|Primary|Overall Survival (OS) at Phase 2 Unfit|OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from time of randomization.|Randomization to Follow-up (4 years)|Full analysis set: all randomized participants of Phase 2 Unfit arm.|||Months||80% Confidence Interval|Median
1371858|NCT01546038|Primary|Percentage of Participants With Complete Response (CR) at Phase 2 Fit|For AML participants:CR were those with repeat bone marrow showing <5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils>=1000/mcL and platelets>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing <=5% myeloblasts, peripheral blood showing neutrophils>=1000/mcL, platelets>=100,000/mcL, 0% blast and hemoglobin (Hgb)>= 11 g/dL, normal maturation of all cell lines.|1 year|Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication.|||Percentage of participants||80% Confidence Interval|Number
1371859|NCT01546038|Primary|Number of Participants With Dose-limiting Toxicities (DLTs) at Phase 1B|A DLT was any of the following adverse events (AEs) in Cycle 1 and considered by the investigator possibly related to glasdegib in combination with chemotherapy: (1) Grade >= 3 non-hematologic toxicity, excluding Grade >= 3 infection, fever (including febrile neutropenia), infusion related AEs, electrolyte abnormalities and ALT/AST elevation that returned to Grade <= 1 or baseline within 7 days; (2) prolonged myelosuppression that lasted longer than 42 days from the point of detection, defined as absolute neutrophil count (ANC) < 500/microliter(mcL) or platelet count < 10 *10^9/L with a normal bone marrow (<5% blasts and no evidence of disease or dysplasia); (3) inability to deliver at least 80% of the planned study doses for all agents in a combination due to non-hematologic toxicities; (4) Delay of >28 days in receiving the next scheduled cycle due to persisting non-hematologic toxicities. Arm A: Glasdegib+LDAC; Arm B: Glasdegib+Decitabine; Arm C: Glasdegib+Cytarabine/Daunorubicin.|Arms A and B: Cycle 1, Day 1 to Day 28; Arm C: Cycle 1, Day -3 to Day 21 or to Day 28 depending on when the next chemotherapy cycle was started|Per protocol analysis set: all enrolled participants in the dose escalation component who received at least 1 dose of glasdegib and of the co-administered chemotherapeutics and who did not have major treatment deviations during the DLT monitoring period.|||Participants|||Number
1371860|NCT01545843|Secondary|Neurological Function (Emotional Perception)|Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT)|0 weeks, 2 weeks, 8 weeks|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||percentage of emotions accurately ID'ed||Standard Deviation|Mean
1371861|NCT01545843|Secondary|Change in Neurologic Functioning: Reaction Time|Reaction Time is measured using a modified Go/No-go test of inhibitory control|0, 2, 8 weeks|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||milliseconds||Standard Deviation|Mean
1371862|NCT01545843|Secondary|Change in Neuropsychological Functioning: Memory|Change in different aspects of thinking (e.g., memory, attention, executive functioning)|Baseline, 2 weeks, 8 weeks|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||words||Standard Deviation|Mean
1371863|NCT01545843|Secondary|Change in EEG Sleep Measures II (Sleep Efficiency)|Measurement of EEG activity during sleep using polysomnography: Sleep efficiency [(total sleep time/time in bed)*100]|Baseline, 2 weeks, 8 weeks|Subsequent rows have lower numbers of participants analyzed due to participant flow and/or unusable data.|||percent of sleep time||Standard Deviation|Mean
1371864|NCT01545843|Secondary|Change in EEG Sleep Measures I: Total Sleep Time|Measurement of EEG activity during sleep using polysomnography: Total Sleep Time is the length of time from sleep onset to final wake up minus any wakefulness during the night. It reflects the total amount of time asleep during the night.|Baseline, 2 weeks, 8 weeks|Number of participants analyzed decreases in subsequent rows, as some participants dropped out or had unusable data.|||minutes||Standard Deviation|Mean
1371865|NCT01545843|Secondary|Pittsburgh Sleep Quality Index|Self-report measure of sleep quality. The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.|Baseline, 2 weeks and 8 weeks post-treatment|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||units on a scale||Standard Deviation|Mean
1371866|NCT01545843|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.|Post-treatment (8 weeks)||||units on a scale||Standard Deviation|Mean
1371868|NCT01545765|Primary|Duration of Anesthesia(Minutes)|Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).|From T0 (product removal) up to T8 hours after product removal|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.|||Minutes||Full Range|Median
1371869|NCT01545765|Secondary|Adverse Events|Incidence of adverse events was to be reported during the study period|During the study|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.|||participants|||Number
1371870|NCT01545700|Primary|Serum Blood Glucose Concentrations|Serum blood glucose concentrations|Patient were followed for the duration of hospitalization, for an average of 6 days|per protocol|||mg/dl||Standard Deviation|Mean
1371871|NCT01545700|Secondary|Pain Scores|VAS pain scoes at rest 0=no pain, 100=worst pain imaginable|Patients were followed for the duration of hospitalization, for an average of 6 days||||0-100 VAS scale scores on a scale||Standard Deviation|Mean
1371872|NCT01545583|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf)||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to calculate AUC0-inf.|||hour*nanograms/milliliter (h*ng/mL)||Standard Deviation|Mean
1371873|NCT01545583|Secondary|Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to estimate Cmax.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
1371874|NCT01545583|Secondary|Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had serum epiregulin measurements.|||hour*picograms/milliliter (h*pg/mL)||Standard Deviation|Mean
1371875|NCT01545583|Secondary|Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα)||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had TGFα measurements.|||hour*nanograms/milliliter (h*ng/mL)||Standard Deviation|Mean
1371876|NCT01545583|Primary|Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)|Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.|From baseline up to 8 weeks post dose|All randomized participants who received at least one dose of study drug.|||participants|||Number
1371877|NCT01545518|Primary|Immune Abnormalities|neuronal nuclear, cytoplasmic, and cell surface autoantibodies|Screening visit|No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.||||||
1371878|NCT01545388|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1371879|NCT01545388|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Up to 26 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
1371880|NCT01545388|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Based on a cLDA model with terms for treatment, other prior AHA therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1371881|NCT01545388|Primary|Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)|Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1371882|NCT01545375|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Day 0 to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.|||Participants|||Count of Participants
1371947|NCT01545076|Secondary|Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period|The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.|||units on a scale||Full Range|Median
1371883|NCT01545375|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 31-day (Days 0-30) period post booster vaccination|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.|||Participants|||Count of Participants
1371884|NCT01545375|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno/reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.|||Participants|||Count of Participants
1371885|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination – Immuno/Reacto Sub-cohort|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-booster vaccination period|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.|||Participants|||Count of Participants
1371886|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination – Immuno/Reacto Sub-cohort|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-primary vaccination period following each dose|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.|||Participants|||Count of Participants
1371887|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-booster vaccination period|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.|||Participants|||Count of Participants
1371888|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-primary vaccination period following each dose|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.|||Participants|||Count of Participants
1371889|NCT01545375|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]|||||||
1371890|NCT01545375|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]|||||||
1371891|NCT01545375|Secondary|Antibody Concentrations Against Vaccine Serotypes 6C|No analysis was performed on antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]|The analysis was to be performed on the ATP cohort for immunogenicity. But no analysis was performed for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
1371892|NCT01545375|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]|||||||
1371893|NCT01545375|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Immuno/Reacto Sub-cohort|Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. Results at time point post booster (Month 22) were not analized at the time of posting; They will be added as soon as they are available.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11).|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1371894|NCT01545375|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies|Inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively|The analysis was to be performed on the according to protocol cohort for immunogenicity. But inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.||||||
1371895|NCT01545375|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Immuno/Reacto Sub-cohort|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).~Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies."|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1371896|NCT01545375|Secondary|Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx – Carriage Sub-cohort|Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed.|At 6-12 weeks of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22)|Analysis was performed on the Total vaccinated cohort for carriage which included around 400 subjects not included in the immuno/reacto sub-cohort, who had received at least one vaccination dose and for whom data concerning carriage outcome measures were available.|||Participants|||Count of Participants
1371897|NCT01545375|Secondary|Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode.|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).~A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371898|NCT01545375|Secondary|Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).~ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371941|NCT01545076|Secondary|Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy|The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||kPa||Standard Deviation|Mean
1371899|NCT01545375|Secondary|Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI)|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).~ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371900|NCT01545375|Secondary|Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage|AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode.|From the administration of dose 1 up to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.|||Participants|||Count of Participants
1371901|NCT01545375|Secondary|Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM)|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).~Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371902|NCT01545375|Secondary|Time to Occurrence of Any Draining Acute Otitis Media (AOM)|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).~Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371903|NCT01545375|Secondary|Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM)|Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology.|From the administration of dose 1 up to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.|||Participants|||Count of Participants
1371904|NCT01545375|Secondary|Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).~Definition of clinical AOM diagnosed and verified against modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional:~1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is indicated by any of the following: a) Bulging of tympanic membrane, b) Limited or absent mobility of tympanic membrane, c) Air-fluid level behind tympanic membrane, d) Otorrhea OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371905|NCT01545375|Secondary|Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).~A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371942|NCT01545076|Secondary|Time to Improvement During IgPro10 Re-stabilization Therapy|Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, Mean Grip strength improvement by at least 8 kPa in one hand, or MRC Sum score >=3.|Up to 13 weeks|Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.|||Days||95% Confidence Interval|Median
1371906|NCT01545375|Primary|Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria|"Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).~Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP [AAP, 2004], as per the judgment of a treating physician or equivalent licensed medical professional:~A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear[s] that resulted in interference with or precluded normal activity or sleep)."|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified according to protocol cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
1371907|NCT01545336|Secondary|Six Minute Walk Distance||Baseline, 3 months||||% change from baseline||Inter-Quartile Range|Median
1371908|NCT01545336|Primary|Tricuspid Annular Plane Systolic Excursion (TAPSE)||Baseline, 3 months||||% change from baseline||Inter-Quartile Range|Median
1371909|NCT01545336|Primary|Plasma Estradiol (E2) Level||Baseline, 3 months||||% change from baseline||Inter-Quartile Range|Median
1371910|NCT01545232|Secondary|Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission||24 hours after ED admission|Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized.|||units of blood products||Inter-Quartile Range|Median
1371911|NCT01545232|Secondary|ICU Free Days||first 30 days after ED admission|Number of ICU free days for each group.|||days||Inter-Quartile Range|Median
1371912|NCT01545232|Secondary|Ventilator Free Days||first 30 days after ED admission|Number of ventilator free days for each group.|||days||Inter-Quartile Range|Median
1371913|NCT01545232|Secondary|Initial Hospital Discharge Status||Hospital discharge or 30 days, whichever comes first|Disposition of subject at time of hospital discharge|||participants|||Number
1371914|NCT01545232|Secondary|Incidence of Transfusion Related Serious Adverse Events||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of transfusion related serious adverse events-Reportable to FDA|||participants|||Number
1371915|NCT01545232|Secondary|Incidence of Primary Surgical Procedure||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of primary surgical procedure|||participants|||Number
1371916|NCT01545232|Secondary|Functional Status at Time of Hospital Discharge|The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.|Hospital discharge or 30 days, whichever comes first|Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) > 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum).|||units on the GOSE scale||Inter-Quartile Range|Median
1371917|NCT01545232|Secondary|Amount of Randomized Blood Products Given to Hemostasis||24 hours from randomization||||units of blood products||Inter-Quartile Range|Median
1371918|NCT01545232|Secondary|Time to Hemostasis|Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.|ED admission to hospital discharge or 30 days, whichever comes first|Time to anatomic hemostasis|||minutes||Inter-Quartile Range|Median
1371919|NCT01545232|Secondary|Hospital Free Days||first 30 days after ED admission|Number of hospital free days for each group.|||days||Inter-Quartile Range|Median
1371920|NCT01545232|Primary|Coagulation and Inflammatory Phenotypes at Emergency Department Admission and Over Time.||72 hours|||||||
1371921|NCT01545232|Primary|30-day Mortality||First 30 days after ED admission|Number of subjects enrolled into each group.|||participants|||Number
1371922|NCT01545232|Primary|24-hour Mortality||First 24 hours after ED admission|Number of subjects who were randomized to each group|||participants|||Number
1371923|NCT01545193|Secondary|PACU Length of Stay|The time required to meet discharge criteria and achieve actual discharge will be noted.|Early postoperative period, up to 24 hours||||minutes||Inter-Quartile Range|Median
1371924|NCT01545193|Secondary|Respiratory Events Potentially Related to Residual Neuromuscular Blockade|Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation < 94% on pulse oximetry) in the PACU|Early postoperative period, up to 24 hours||||participants|||Number
1371925|NCT01545193|Secondary|Signs and Symptoms of Residual Neuromuscular Blockade|A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission|Early postoperative period, up to 24 hours||||symptoms||Inter-Quartile Range|Median
1371926|NCT01545193|Primary|Incidence of Residual Neuromuscular Blockade|The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.9 in each group will be compared.|Early postoperative period, up to 24 hours||||participants|||Number
1371927|NCT01545076|Secondary|Change in INCAT During IgPro10 Rescue Therapy|The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
1371928|NCT01545076|Secondary|Change in R-ODS During IgPro10 Rescue Therapy|The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
1371929|NCT01545076|Secondary|Change in MRC Sum Score During IgPro10 Rescue Therapy|An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
1371930|NCT01545076|Secondary|Change in Mean Grip Strength During IgPro10 Rescue Therapy|The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||kPa||Standard Deviation|Mean
1371931|NCT01545076|Secondary|Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy||Up to 13 weeks|RSDS|||percentage of subjects|||Number
1371932|NCT01545076|Secondary|Number of Subjects With Adverse Events During IgPro10 Rescue Therapy||Up to 13 weeks|RSDS|||participants|||Number
1371933|NCT01545076|Secondary|Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy||Up to 13 weeks|RSDS|||Adverse events/Infusion|||Number
1371934|NCT01545076|Secondary|Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy|Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline score..The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.|Up to 13 weeks|Rescue Medication Safety Data Set (RSDS): The RSDS consists of subjects of the SDS who received at least 1 dose of IgPro10 rescue medication.|||Days||95% Confidence Interval|Median
1371935|NCT01545076|Secondary|Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy||Up to 13 weeks|PSDS|||percentage of subjects|||Number
1371936|NCT01545076|Secondary|Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy||Up to 13 weeks|PSDS|||participants|||Number
1371937|NCT01545076|Secondary|Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy||Up to 13 weeks|PSDS|||Adverse events/Infusion|||Number
1371938|NCT01545076|Secondary|Change in INCAT During IgPro10 Re-stabilization Therapy|The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
1371939|NCT01545076|Secondary|Change in R-ODS During IgPro10 Re-stabilization Therapy|The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
1371940|NCT01545076|Secondary|Change in MRC Sum Score During IgPro10 Re-stabilization Therapy|An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
1371943|NCT01545076|Secondary|Percentage of Subjects With Adverse Events During the SC Treatment Period||Up to 28 weeks|SDS|||percentage of subjects|||Number
1371944|NCT01545076|Secondary|Number of Subjects With Adverse Events During the SC Treatment Period||Up to 28 weeks|SDS|||Participants|||Count of Participants
1371945|NCT01545076|Secondary|Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period||Up to 28 weeks|Safety Data Set (SDS): The SDS consists of all randomized subjects who received at least 1 dose of IgPro20 or placebo.|||Adverse events/Infusion|||Number
1371948|NCT01545076|Secondary|Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period|An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.|||units on a scale||Full Range|Median
1371949|NCT01545076|Secondary|Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period|The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure..|||Kilopascal (kPa)||Full Range|Median
1371950|NCT01545076|Secondary|Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period|The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.|||units on a scale||Full Range|Median
1371951|NCT01545076|Primary|Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period|Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score). The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (“No upper limb problems”) to 5 (“Inability to use either arm for any purposeful movement”), and scores for leg disability range from 0 (“Walking not affected”) to 5 (“Restricted to wheelchair, unable to stand and walk a few steps with help”). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the “adjusted” INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.|Up to 25 weeks|Intention-to-treat Set (ITTS): The ITTS consists of all randomized subjects who received at least 1 dose of IgPro20 / placebo and satisfied inclusion criterion #1 (diagnosis of CIDP).|||percentage of subjects|||Number
1371952|NCT01544998|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||pmol/min||Standard Deviation|Mean
1371953|NCT01544998|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||pmol/min||Standard Deviation|Mean
1371954|NCT01544998|Secondary|Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.|||mL/min/1.73 m^2||Standard Deviation|Mean
1371955|NCT01544998|Secondary|Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||mL/min/1.73 m^2||Standard Deviation|Mean
1371956|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.|||mEq/min||Standard Deviation|Mean
1371957|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||mEq/min||Standard Deviation|Mean
1371958|NCT01544920|Secondary|Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24|SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in, who were randomized at Week 4, and also had undetectable HCV RNA at Week 4.|||Percentage of participants|||Number
1371959|NCT01544920|Primary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)|SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 74|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in and who were randomized at Week 4.|||Percentage of participants|||Number
1371982|NCT01544348|Secondary|Observed Serum Concentration|Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.|Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85|Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1371960|NCT01544582|Secondary|Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash|The incidence (events per 1000 participant-days) of the protocol-defined HOIs (anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash) was calculated over the 48-week period following the start of CHC treatment exposure. All protocol-defined HOIs were taken into account (serious and non-serious HOIs). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The incidence per 1000 participant-days of anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash were reported by CHC treatment group of exposure with 95% confidence intervals.|Up to 48 weeks of treatment|Participants in Analysis Population (CHC genotype-1 participants meeting eligibility criteria and treated with boceprevir+PR, telaprevir+PR, or PR alone) with available data who did not already experience HOI during 3 months preceding CHC treatment regimen. Participants categorized by treatment group of exposure further described in Arm Description|||events per 1000 participant-days||95% Confidence Interval|Number
1371961|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid (TC), intravenous (IV) and/or oral (PO) corticosteroids (IV/PO CS), emollients/moisturizers (E/M), antihistamines (AH), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of serious rash episodes managed by a particular intervention are reported out of the total number of managed serious rash episodes with data available for that intervention (i.e. serious rash episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
1371962|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention|Serious rash was considered a HOI for this study and included rash > 50% of body surface area, rash associated with significant systemic symptoms, or rash resulting in hospitalization or urgent care visit. Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid use, intravenous (IV) and/or oral corticosteroids, emollients/moisturizers, antihistamines, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of serious rash episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
1371963|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin (TPO), platelet transfusion (PT), other treatment (OT) , and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of grade 3/4 thrombocytopenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 thrombocytopenia episodes with data available for that intervention (i.e. grade 3/4 thrombocytopenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
1371964|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 thrombocytopenia (Grade 3: platelet count 25 - <50 × 10^9/L, Grade 4: <25 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin, platelet transfusion, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 thrombocytopenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
1371999|NCT01544309|Primary|Change in HbA1c Level||Baseline, 12 months after administration|Participants in FAS except the ones who had no HbA1c data at 12 months.|||Amount of change (%)||Standard Deviation|Mean
1372000|NCT01544309|Primary|Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level||Baseline, and 12 months after administration|Participants in full analysis set (FAS) except the ones who had no HDL-C data at 12 months.|||Percent change||Standard Deviation|Mean
1371965|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use, other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). More than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of grade 3/4 neutropenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 neutropenia episodes with data available for that intervention (i.e. grade 3/4 neutropenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
1371966|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 neutropenia (Grade 3: neutrophil count 0.5 - <0.75 × 10^9/L, Grade 4: <0.5 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 neutropenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
1371967|NCT01544582|Primary|Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes|"Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion (BT), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). Interventions could be used in combination (e.g. ESA plus blood transfusion) and more than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of anemia episodes managed by a particular intervention are reported out of the total number of managed anemia episodes with data available for that intervention (i.e. anemia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
1371968|NCT01544582|Primary|Percentage of Anemia Episodes Managed by at Least One Clinical Intervention|Anemia (hemoglobin <10 g/dL) was considered a Health Outcome of Interest (HOI) for this study. Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion, drug dose reduction, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of anemia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
1371969|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score|The Child-Pugh Score is used to determine the prognosis of chronic liver disease, in particular cirrhosis. It is classified into Classes A (best prognosis) to C (worst prognosis). Child-Pugh scores assessed within 3 months before CHC treatment regimen initiation were recorded from the eCRF, and the number of participants who were Grade A, Grade B, Grade C, not assessed, or unknown whether assessed were reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (Child Pugh score).|||participants|||Number
1371970|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load|Participant baseline HCV viral load was recorded from the eCRF and categorized as either “Low” (<800,000 IU/mL or <2,000,000 RNA copies/mL) or “High” (≥800,000 IU/mL or ≥2,000,000 RNA copies/mL).|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (viral load).|||participants|||Number
1372283|NCT01541865|Secondary|Angiographically-documented Renal Stenosis Requiring an Intervention||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||participants|||Number
1371971|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype|Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (HCV genotype).|||participants|||Number
1371972|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)|Baseline mean body mass index (SD) in Kg/m^2 was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (BMI).|||Kg/m^2||Standard Deviation|Mean
1371973|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height|Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (height).|||centimeters||Standard Deviation|Mean
1371974|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight|Baseline mean weight (standard deviation [SD]) in kilograms (Kg) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (weight).|||kilograms (Kg)||Standard Deviation|Mean
1371975|NCT01544582|Primary|Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)|The percentage of CHC participants initiating boceprevir plus PR treatment, telaprevir plus PR treatment, or PR treatment alone was determined from a Drug Utilization questionnaire that was administered to physicians using an electronic Case Report Form (eCRF) to collect site level information and reported with 95% confidence intervals.|Up to 37 months|Analysis Population: All CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone.|||percentage of participants||95% Confidence Interval|Number
1371976|NCT01544478|Primary|Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18|The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.|Up to Month 48|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for the relevant HPV type.|||Cases per 100 person-years at risk|Person-years at risk|95% Confidence Interval|Number
1371977|NCT01544361|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814||Day 1, 29, 57, 85, and 106|Analyses of immunogenicity was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.||||||
1371978|NCT01544361|Secondary|Pharmacokinetic (PK) Parameters of MEDI7814|Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed.|Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106|Analyses of PK was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.||||||
1371979|NCT01544361|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Day 1 to Day 106|Safety population included all randomized participants who received MEDI7814 and had safety data available.|||Participants|||Number
1371980|NCT01544348|Secondary|Free Immunoglobulin E (IgE) Serum Concentration||Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only|Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively.|||ng/mL||Standard Deviation|Mean
1371981|NCT01544348|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit|Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.|Days 1 (pre-dose), 15, 43, and 85|Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result.|||participants|||Number
1372001|NCT01544179|Secondary|Time to Worsening in Lung Cancer Subscale|A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Weeks||95% Confidence Interval|Median
1371983|NCT01544348|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 to 85|Safety population included all participants who received any amount of investigational product and had safety data available.|||participants|||Number
1371984|NCT01544309|Secondary|Change From Baseline in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）||||μg/mL||Standard Deviation|Mean
1371985|NCT01544309|Secondary|Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007|Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.|3 months after administration, the end of starting dose and the end of study treatment|Full analysis set except participants who have reached the target LDL-C level specified at the treatment start|||Percentage of participants||95% Confidence Interval|Number
1371986|NCT01544309|Secondary|Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation|Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)|Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|||||||
1371987|NCT01544309|Secondary|Percent Change in Non-HDL-C Level||Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no non-HDL-C level data at 12 months.|||Percent change||Standard Deviation|Mean
1371988|NCT01544309|Secondary|Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)||Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no lipids level data at 12 months.|||Percent change||Standard Deviation|Mean
1371989|NCT01544309|Secondary|Frequency of Serious Adverse Events (SAE)||Up to 12 months||||Number of patients with SAE|||Number
1371990|NCT01544309|Secondary|Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)||From the start of the treatment to the end of study treatment||||Number of patients with any events|||Number
1371991|NCT01544309|Secondary|Change From Baseline in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.|||μU/mL||Standard Deviation|Mean
1371992|NCT01544309|Secondary|Percent Change in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa.|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug|||Percent change||Standard Deviation|Mean
1371993|NCT01544309|Secondary|Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）||||mg/dL||Standard Deviation|Mean
1371994|NCT01544309|Secondary|Percent Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no blood glucose level data at 12 months.|||Percent change||Standard Deviation|Mean
1371995|NCT01544309|Secondary|Change in HbA1c Level||Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.|||Amount of change (%)||Standard Deviation|Mean
1371996|NCT01544309|Secondary|Percent Change in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no 1,5-AG data at 12 months.|||Percent change||Standard Deviation|Mean
1371997|NCT01544309|Secondary|Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status|“Deterioration of diabetic treatment status” is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.|Baseline, 3, 6, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.|||participants|||Number
1371998|NCT01544309|Secondary|Occurrence of Deterioration of Diabetic Treatment Status|“Deterioration of diabetic treatment status” is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%.|Baseline, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.|||Participants|||Number
1372284|NCT01541865|Secondary|Sudden Cardiac Death at Time of Procedure||Duration of the procedure (average of 65 minutes)||||participants|||Number
1372002|NCT01544179|Secondary|Improvement in Lung Cancer Subscale|An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Number of participants improving|||Number
1372003|NCT01544179|Secondary|Time to Worsening in FACT-L Total Score|A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Weeks||95% Confidence Interval|Median
1372004|NCT01544179|Secondary|Improvement in FACT-L Total Score|An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Number of patients improving|||Number
1372005|NCT01544179|Secondary|Time to Worsening in Trial Outcome Index|A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Weeks||95% Confidence Interval|Median
1372006|NCT01544179|Secondary|Improvement in Trial Outcome Index|An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Number of participants improving|||Number
1372007|NCT01544179|Secondary|Disease Control Rate (DCR)|DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must have shown an absolute increase of ≥5mm|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set|||Percentage of Participants|||Number
1372008|NCT01544179|Secondary|Objective Response Rate (ORR) (Site Read Data)|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set|||Percentage of Participants|||Number
1372009|NCT01544179|Secondary|Median Overall Survival (OS) at Time of PFS Analysis||Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.|Full analysis set|||Months||95% Confidence Interval|Median
1372010|NCT01544179|Secondary|Overall Survival (OS)|OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.|Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.|Full analysis set|||Number of patients with an OS event|||Number
1372011|NCT01544179|Primary|Median Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)|||Months||95% Confidence Interval|Median
1372012|NCT01544179|Primary|Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)|||Patients with a progression event|||Number
1372025|NCT01544166|Secondary|Number of Subjects With Final Diagnosis|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372285|NCT01541865|Secondary|Myocardial Infarction at Time of Procedure||Duration of the procedure (average of 65 minutes)||||participants|||Number
1372013|NCT01544166|Other Pre-specified|Number of Subjects With Drug Related Serious and Non- Serious Adverse Events|An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a “reasonable causal relationship” to the study treatment.|From baseline to approximately 7 days after injection|SAF included all subjects who received any amount of gadobutrol.|||subjects|||Number
1372014|NCT01544166|Secondary|Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection|eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k * height / Scr where k = 0.45 in term newborn infants < 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413*height/Scr.|Before gadobutrol injection|"SAF included all subjects who received any amount of gadobutrol. Here n included subjects who were evaluable at specified age group."|||milliliter/minute/1.73 square||Standard Deviation|Mean
1372015|NCT01544166|Secondary|Number of Subjects With Clinically Significant Abnormal Laboratory Values|Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.|Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection|Safety Analysis Set (SAF) included all subjects who received any amount of gadobutrol.|||subjects|||Number
1372016|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372017|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372018|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372019|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372020|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372021|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372022|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372023|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372024|NCT01544166|Secondary|Number of Subjects With Final Diagnosis by Body Region|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372085|NCT01543958|Secondary|Primary Adverse Events|Number of subjects experiencing primary adverse events, defined as all reported Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities and other serious adverse events (SAEs)|baseline and week 16|All 40 subjects enrolled in A5296 were included in this analysis.|||participants|||Number
1372026|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis by Body Region|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372027|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372028|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain by Body Region|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372029|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372030|NCT01544166|Secondary|Number of Subjects With Diagnoses by Body Region|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372031|NCT01544166|Secondary|Number of Subjects With Diagnoses|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372032|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372033|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372034|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel by Body Region|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372035|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372036|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel by Body Region|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372037|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372038|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected by Body Region|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.|||subjects|||Number
1372039|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.|||subjects|||Number
1372040|NCT01544166|Secondary|Number of Subjects With Presence of Pathology by Body Region|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded. Results per body region were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372041|NCT01544166|Secondary|Number of Subjects With Presence of Pathology|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372042|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality by Body Region|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372043|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372044|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis by Body Region|The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372045|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis|The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372086|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372046|NCT01544166|Secondary|Number of Subjects With Anatomical Area Evaluated|Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
1372047|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|30 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. C30 was simulated for 2400 virtual paediatric participants.|||micromole/L||Full Range|Median
1372048|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|20 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. Here number of subjects analysed= 43. C20 was simulated for 2400 virtual paediatric participants.|||micromole/L||Full Range|Median
1372049|NCT01544166|Primary|Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual|Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||hours||Full Range|Median
1372050|NCT01544166|Primary|Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual|MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||hours||Full Range|Median
1372051|NCT01544166|Primary|Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||L/kg||Full Range|Median
1372052|NCT01544166|Primary|Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual|Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h*kg).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||L/(h*kg)||Full Range|Median
1372053|NCT01544166|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual|AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole*hour per liter (micromole*h/L).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|Per-protocol set (PPS) included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||micromole*h/L||Full Range|Median
1372054|NCT01544153|Secondary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence"|3 months post-randomization|Intent to treat|||Participants|||Count of Participants
1372055|NCT01544153|Primary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence."|9 months post-randomization|Intent to treat|||Participants|||Count of Participants
1372056|NCT01544114|Secondary|PK of Naproxen: Trough Plasma Concentrations|Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.|Month 1 and Month 3: pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1372286|NCT01541865|Secondary|Cerebrovascular Accident (CVA) at Time of Procedure||Duration of the procedure (average of 65 minutes)||||participants|||Number
1372057|NCT01544114|Secondary|PK of Esomeprazole: Oral Volume of Distribution (V/F)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||L||Geometric Coefficient of Variation|Geometric Mean
1372058|NCT01544114|Secondary|PK of Esomeprazole: Absorption Rate Constant (Ka)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||h^-1||Geometric Coefficient of Variation|Geometric Mean
1372059|NCT01544114|Secondary|PK of Esomeprazole: Oral Plasma Clearance (CL/F)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1372060|NCT01544114|Secondary|Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||hr*µmol/L||Geometric Coefficient of Variation|Geometric Mean
1372061|NCT01544114|Primary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug|An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.|SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.|Safety analysis set: all participants who received at least 1 dose of study drug; participants were categorized according to the treatment medication they actually took.|||participants|||Number
1372062|NCT01544062|Secondary|48 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 7 study subjects in normal saline group and 4 study subjects in IV acetaminophen group.|||participants|||Number
1372063|NCT01544062|Secondary|24 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
1372064|NCT01544062|Secondary|48 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.|||participants|||Number
1372065|NCT01544062|Secondary|24 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
1372066|NCT01544062|Secondary|48 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.|||participants|||Number
1372067|NCT01544062|Secondary|24 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
1372287|NCT01541865|Secondary|Renal Artery Infarction or Embolus||Duration of the procedure (average of 65 minutes)||||participants|||Number
1372068|NCT01544062|Secondary|48 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 8 study subjects in normal saline group and 6 study subjects in IV acetaminophen group.|||participants|||Number
1372069|NCT01544062|Secondary|24 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
1372070|NCT01544062|Secondary|48 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU||||participants|||Number
1372071|NCT01544062|Secondary|24 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU||||participants|||Number
1372072|NCT01544062|Secondary|48 Hour Patient Satisfaction|"The extent to which subjects overall pain experience met their expectations question responses were converted to the Likert scale with the following values: not at all (1), a little (2), a fair amount (3), very much (4) and extremely well (5)."|48 hours after arriving in ICU|Questionnaire not completed by 12 study subjects in normal saline group and 10 study subjects in IV acetaminophen group.|||units on a scale||Standard Deviation|Mean
1372073|NCT01544062|Secondary|Length of ICU Stay|The length of ICU stay will be determined based on the “ICU Discharge Criteria” checklist that will be completed by nursing staff every 4 hours until ICU discharge.|From the time of arrival in ICU until ICU discharge||||hours||Standard Deviation|Mean
1372074|NCT01544062|Secondary|Length of Mechanical Ventilation|The length of mechanical ventilation will be determined based on the “Extubation Criteria” checklist that will be completed by nursing staff every 2 hours until extubation.|From the time of arrival in ICU until extubation||||minutes||Standard Deviation|Mean
1372075|NCT01544062|Secondary|48 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.|||cm||Standard Deviation|Mean
1372076|NCT01544062|Secondary|24 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||cm||Standard Deviation|Mean
1372077|NCT01544062|Secondary|48 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
1372078|NCT01544062|Secondary|24 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
1372079|NCT01544062|Secondary|48 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
1372080|NCT01544062|Secondary|24 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data for 3 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
1372081|NCT01544062|Secondary|48 Hour Postoperative Opioid Consumption|48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|48 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.|||mg||Standard Deviation|Mean
1372082|NCT01544062|Primary|24 Hour Postoperative Opioid Consumption|The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|24 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.|||mg||Standard Deviation|Mean
1372083|NCT01544023|Secondary|Complication Rate|Secondary study outcome was the prevalence of complications.|2 years||||percentage of participants|||Number
1372084|NCT01544023|Primary|Participants Who Received TiLOOP Mesh Reconstruction|Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM.|1 month||||Patients with TiLOOP mesh reconstruction|||Number
1372288|NCT01541865|Secondary|Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery||Duration of the procedure (average of 65 minutes)||||participants|||Number
1372087|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372088|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372089|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372090|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from week 8 to week 16|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372091|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372092|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372093|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372094|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372095|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372096|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372097|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372098|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372099|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
1372100|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
1372101|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
1372133|NCT01543958|Primary|Change in Soluble CD14 (sCD14)|Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.|||ug/mL||Inter-Quartile Range|Median
1372102|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from week 8 to week 16, where baseline is the average of pre-entry and entry|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
1372103|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
1372104|NCT01543958|Secondary|Change in C-reactive Protein (CRP)|Changes in levels of systemic inflammation marker CRP from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
1372105|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372106|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372107|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372108|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||cells/mm^3||Inter-Quartile Range|Median
1372109|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||cells/mm^3||Inter-Quartile Range|Median
1372110|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||cells/mm^3||Inter-Quartile Range|Median
1372111|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||log10(copies/mL)||Inter-Quartile Range|Median
1372112|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.|||log10(copies/mL)||Inter-Quartile Range|Median
1372113|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||log10(copies/mL)||Inter-Quartile Range|Median
1372114|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from week 8 to week 16|from week 8 to week 16|Among 40 subjects enrolled in A5296, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372115|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 8|Baseline to Week 8|Among 40 subjects enrolled in A5296, 37 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372116|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 4, where baseline value is the average of pre-entry and entry|from baseline to week 4|Among 40 subjects enrolled in A5296, 39 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
1372117|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from week 8 to week 16 in cycling CD4+ , defined as the %Ki67+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372349|NCT01541254|Secondary|Device and Procedure Related Serious Adverse Events|All Serious Adverse events will be reported per protocol|Day 1-6months(± 4 months)|||||||
1372118|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 8 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372119|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 4 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372120|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from week 8 to week 16 in cycling CD8+ , defined as the %Ki67+|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372121|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 8 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372122|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 4 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372123|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372124|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372125|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change from baseline to week 4 in CD8+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372126|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from week 8 to week 16 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372127|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 4 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372128|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 8 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
1372129|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects had valid data at both week 8 and week 16 and were included in this secondary analysis.|||ug/mL||Inter-Quartile Range|Median
1372130|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.|||ug/mL||Inter-Quartile Range|Median
1372131|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid endpoint at both week 8 and week 16 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372132|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
1372350|NCT01541254|Secondary|Stent Migration at 6 Months|Angiographic images will be comparing post procedure sent position to 6 months|6 months|||||||
1372134|NCT01543958|Primary|Change in Endotoxin|Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.|baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.|||pg/mL||Inter-Quartile Range|Median
1372135|NCT01543828|Primary|Time (in Minutes) to Patient's Perception of Onset of Effect|"Defined as the first time point that the patient responds yes to the following self-administered question:~I feel that the drug is working in improving my breathing?"|5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2|Full Analysis Set included all participants who received one dose of study drug.|||Minutes||Standard Deviation|Mean
1372136|NCT01543685|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
1372137|NCT01543685|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
1372138|NCT01543685|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
1372139|NCT01543685|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
1372140|NCT01543685|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
1372141|NCT01543685|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
1372170|NCT01543503|Secondary|Mean Change From Baseline in Tender Joint Count|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||Number of tender joints||95% Confidence Interval|Least Squares Mean
1372142|NCT01543685|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
1372143|NCT01543685|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
1372144|NCT01543607|Secondary|Effectiveness: Change From Baseline in Bile Duct Diameter.|Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture.|2 years||||percentage of improvement:|||Number
1372145|NCT01543607|Secondary|Feasibility: Ease of the Radiofrequency Ablation Catheter Placement|Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter.|2 years||||units on a scale|||Number
1372146|NCT01543607|Primary|Safety: Number of Bile Leak After RFA Procedure|Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)|2 years||||bile leak|||Number
1372147|NCT01543581|Secondary|Complete Response Rate|A secondary variable is the complete response rate, defined as the proportion of patients with no histological evidence of basal cell carcinoma on the post treatment MMS excision of the target tumor area. For this analysis, the placebo data will be pooled together to calculate the complete response rate for the placebo group.|12 to 14 weeks||||participants|||Number
1372148|NCT01543581|Primary|Mohs Micrographic Surgery (MMS)|The final wound size taken immediately after the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) was determined using pre treatment lesion outlined plus one additional concentric 2mm margin removed to establish an objective consistent measure for wound size. The diameter of the final wound size was measured in mm.|The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.||||mm|||Number
1372149|NCT01543568|Secondary|Mean Number of 0.2 mg Aflibercept Injections Administered||at 6 months||||injections||Full Range|Mean
1372150|NCT01543568|Secondary|Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos||6 Months|Given lack of visual benefit upon switching to aflibercept (Eylea), such analyses were not performed.||||||
1372151|NCT01543568|Secondary|Mean Change in Visual Acuity (BCVA)|Change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to month 6. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|6 Months||||ETDRS BCVA letters||Full Range|Mean
1372152|NCT01543568|Secondary|The Percentage of Patients Who Lose > 15 Letters Visual Acuity||6 Months||||Percentage of patients|||Number
1372153|NCT01543568|Secondary|Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT||6 months||||months||Full Range|Mean
1372154|NCT01543568|Secondary|Mean Change in OCT Central Foveal Thickness||6 Months||||micrometers||Full Range|Mean
1372155|NCT01543568|Primary|The Number of Patients With no Fluid on OCT||6 months||||participants|||Number
1372156|NCT01543503|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|"The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point|||scores on a scale||95% Confidence Interval|Least Squares Mean
1372157|NCT01543503|Secondary|Shift From Baseline in Morning Stiffness|Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis.|||participants|||Number
1372158|NCT01543503|Secondary|Mean Change From Baseline in Visual Analogue Scale Pain Score|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
1372351|NCT01541254|Secondary|Significant Stenosis(>50%) of the Treated Artery at 6 Months|Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.|6 months|||||||
1372159|NCT01543503|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1372160|NCT01543503|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1372161|NCT01543503|Secondary|Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
1372162|NCT01543503|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events|An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
1372163|NCT01543503|Secondary|Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy|An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
1372164|NCT01543503|Secondary|Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period|The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as ‘censored’ at the date study termination.|Up to end of treatment|The safety population was used for analysis.|||participants|||Number
1372165|NCT01543503|Secondary|Reasons for Treatment Discontinuation|The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
1372166|NCT01543503|Secondary|Proportion of Participants Who Terminated Biologic Treatment|The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.|Up to Week 52|The safety population was used for analysis.|||Percentage of participants|||Number
1372167|NCT01543503|Secondary|Loss of Efficacy or Development of Intolerance to Biologic Therapy|Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.|Up to Week 52|The safety population included all recruited participants who received at least one dose of a TNF inhibitor or tocilizumab during the study.|||participants|||Number
1372168|NCT01543503|Secondary|Mean Change From Baseline in Physician Global Assessment Score|The Physician’s Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1372169|NCT01543503|Secondary|Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score|Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
1372171|NCT01543503|Secondary|Mean Change From Baseline in Swollen Joint Count|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||Number of swollen joints||95% Confidence Interval|Least Squares Mean
1372172|NCT01543503|Secondary|Mean Change From Baseline in C-reactive Protein|Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point|||mg/L||95% Confidence Interval|Least Squares Mean
1372173|NCT01543503|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate|Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||mm/hr||95% Confidence Interval|Least Squares Mean
1372174|NCT01543503|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient’s Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 52|The effectiveness analysis population was used for analysis. Data of participants available at the time of the assessment were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1372175|NCT01543503|Primary|Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient’s Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|Participants belonging to the safety population who had first biologic administration within 60 days after the last Rheumatoid Arthritis (RA) disease activity assessment were included in the effectiveness analysis population. Data of participants available at the time of the assessment were included in the analysis.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1372176|NCT01543204|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.|From first dose of study drug until 30 days after the last dose (up to 28 weeks)|Primary analysis set|||participants|||Number
1372177|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Flaking|The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating “no flaking at all” and 10 indicating “worst flaking imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
1372178|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Pain|The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating “does not hurt at all” and 10 indicating “worst hurt imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
1372179|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Itch|The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating “no itch at all” and 10 indicating “worst itch imaginable.” Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
1372190|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
1372191|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372180|NCT01543204|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI)|The impact of disease severity on the participant’s ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value and who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
1372181|NCT01543204|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value – Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
1372182|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 24|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372183|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 12|Participants indicated their level of satisfaction with the medication’s control of psoriasis on a scale from “very dissatisfied” to “very satisfied”.|Week 12|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372184|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percent change||Standard Deviation|Mean
1372185|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant’s palm, excluding the fingers and thumb, represented roughly 1% of the body’s surface. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percent change||Standard Deviation|Mean
1372186|NCT01543204|Secondary|Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percent change||Standard Deviation|Mean
1372187|NCT01543204|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value – Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percent change||Standard Deviation|Mean
1372188|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
1372189|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372192|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
1372193|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372194|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
1372195|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372196|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
1372197|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372198|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||units on a scale||Standard Deviation|Mean
1372199|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1372200|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
1372201|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372202|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
1372203|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
1372204|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set with available data|||percentage of participants||95% Confidence Interval|Number
1372205|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set (all participants who received at least one dose of investigational product during the study) with at least 1 post-baseline value. Participants with missing post-baseline data were imputed using the last observation carried forward (LOCF) method.|||percentage of participants||95% Confidence Interval|Number
1372206|NCT01543178|Primary|Repeat Treatment Responders|Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.|4-week treatment-free follow-up in double-blind repeat treatment phase.|Intent-to-treat population, defined as patients who received ≥ 1 dose of study drug in the double-blind period.|||percentage of patients|||Number
1372207|NCT01543074|Primary|Tmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. The time to achieve highest plasma concentration (Tmax) is shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.||||hours||Standard Deviation|Mean
1372208|NCT01543074|Secondary|Histone Acetylation|Change in histone acetylation|21 days|||||||
1372209|NCT01543074|Primary|Cmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. Cmax (mean +/- SD) values are shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.||||micromoles/L||Standard Deviation|Mean
1372210|NCT01542957|Secondary|Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up|To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.|End of therapy, 3 and 12 month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified|||units on a scale||Standard Deviation|Mean
1372211|NCT01542957|Secondary|Change From Baseline in Hamilton-Depression Rating Scale-17 Items|This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.|End of therapy and 12-month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified.|||units on a scale||Standard Deviation|Mean
1372212|NCT01542957|Primary|Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up|To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.|End of therapy (16 weeks), 3 and 12-month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified|||units on a scale||Standard Deviation|Mean
1372213|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set who had an end-of-treatment response (HCV RNA < LLOQ as the last observed on-treatment value) were analyzed.|||percentage of participants|||Number
1372214|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values|Baseline to Week 12|Full Analysis Set|||percentage of participants|||Number
1372215|NCT01542788|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Post-treatment Week 24|Full Analysis Set|||percentage of participants|||Number
1372216|NCT01542788|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Post-treatment Week 4|Full Analysis Set|||percentage of participants|||Number
1372217|NCT01542788|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.|Baseline to Week 12|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug|||participants|||Number
1372218|NCT01542788|Primary|Percentage of Participants Achieving SVR12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy|Post-treatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1372219|NCT01542684|Primary|Overall Response Rate (ORR)|ORR is percentage total participants with overall response (Complete Response (CR) or Partial Response (PR)) within two treatment cycles. Response based on modified International Working Group (IWG) criteria: Complete response - Bone marrow: 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia noted, Peripheral blood Hgb 11 g/dL, Platelets 100x109/L, Neutrophils 1.0x109/L, Blasts 0%. Partial response: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by 50% over pretreatment but still > 5% , Cellularity and morphology not relevant; Stable disease - Failure to achieve at least PR, but no evidence of progression for > 8 weeks; No Response or Failure - Death during treatment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS French-American-British (FAB) classification subtype than pretreatme|Baseline up to 2 treatment cycles (8 weeks)||||percentage of participants|||Number
1372220|NCT01542645|Secondary|Marker of Myocardial Injury (Troponin I)|In a cohort of patients undergoing only coronary artery bypass graft surgery (n=75), serum troponins will be measured postoperatively to determine whether methadone has a potential cardioprotective effect.|12 hours after surgery||||nanograms per millimeter||Full Range|Median
1372221|NCT01542645|Secondary|Chronic Postoperative Pain Scores||1,3,6, and 12 months after surgery|||||||
1372222|NCT01542645|Secondary|Postoperative Pain Scores|Pain was assessed on a 11-point verbal analogue scale with 0=no pain, 10=worst pain imaginable|2 hours after cardiac surgery||||units on a scale||Full Range|Median
1372223|NCT01542645|Primary|Total Opioid Consumption in the Postoperative Period|Total intravenous morphine used first three days (72 hours after ICU admission)|First 3 days after surgery||||milligrams||Full Range|Median
1372224|NCT01542632|Primary|Rate of Seroconversion to Each of Four Dengue Serotypes|Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Up to 30 days after the last immunization (Up to Day 120)|Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.|||percentage of participants|||Number
1372225|NCT01542632|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 30, 90 and 120 after 1st vaccination|Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point.|||titer||Standard Deviation|Geometric Mean
1372226|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1372227|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1372228|NCT01542632|Secondary|Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations|Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.|various timepoints up to 30 days after each dose (Up to Day 120)|Full Analysis Set included all enrolled participants.|||percentage of participants|||Number
1372229|NCT01542632|Primary|Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported|Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.|Day 0 to Day 104|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1372230|NCT01542541|Secondary|SUVavg in Each Colonic Segment||Day 2||||SUV||Standard Deviation|Mean
1372231|NCT01542541|Primary|SUVmax of FDG in Each Colonic Segment||Day 2||||SUV||Standard Deviation|Mean
1372232|NCT01542528|Secondary|Overall Improvement|Clinical Global Improvement Scale (CGI-I) - responders vs. non-responders. CGI is a seven point scale with the following anchor point: 1=Very Much Improved, 2=Much Improved, 3=Improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. Participants with a score of 1, 2, or 3 at Endpoint were considered Responders; all others were considered non-responders.|15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU)|The analysis population are those with matched cases at 15 weeks.|||Percentage of participants|||Number
1372233|NCT01542528|Primary|Improvement in ADHD Severity From Baseline to End of Intervention|ADHD severity was measured by the Swanson, Nolan, and Pelham Rating Scale (SNAP)-IV-ADHD consists of 18 items that closely parallel in wording the diagnostic symptoms for ADHD as they appear in the DSM-IV. The range of scores are from 0 to 54. Higher scores indicate greater ADHD severity . The blinded assessors (Clinicians) used clinical judgement to provide an overall rating, based on all available information from the parents, teachers, and the assessors' own direct interactions with the child on the day of the assessment.|End of intervention is at a maximum of 15 weeks from baseline.|The analysis population are those with matched cases at 15 weeks.|||units on a scale||Standard Deviation|Mean
1372234|NCT01542502|Other Pre-specified|Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope)|Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.|14 days|||||||
1372242|NCT01542372|Secondary|Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II|A measure of somatic symptoms and cultural syndromes commonly found among distressed Cambodian refugees. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1372243|NCT01542372|Secondary|Change in the SCL Anger Severity at 12 Weeks in Step II|A measure of anger severity, which is the SCL Anger Scale. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1372244|NCT01542372|Secondary|Change in the HSCL Depression Scale at 12 Weeks in Step II|A measure of depression severity, which is the HSCL Depression Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1372245|NCT01542372|Secondary|Change in the HSCL Anxiety Scale at 12 Weeks in Step II|A measure of anxiety severity, which is the HSCL Anxiety Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1372246|NCT01542372|Primary|Change in the PTSD Checklist (PCL) at 12 Weeks in Step II|A measure of PTSD severity, which is the PTSD Checklist. Total score range is 17 to 85, with a higher score indicating greater psychopathology. Change scores were calculated.|Baseline and 12 weeks|Patients with PTSD checklist scores of 30 or above were eligible for Step II, which was medication augmentation or CBT augmentation.|||units on a scale||Standard Deviation|Mean
1372247|NCT01542307|Other Pre-specified|Post-gas Therapy Medication Use|The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.|60 minutes||||percentage of attacks|Migraine attacks||Number
1372248|NCT01542307|Secondary|Final Nausea Score 0-1 on the Visual Analog Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
1372249|NCT01542307|Secondary|Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
1372250|NCT01542307|Secondary|Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
1372251|NCT01542307|Secondary|Final Pain Severity Score 0–1 on the Visual Analogue Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
1372252|NCT01542307|Secondary|Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|Baseline (0 minutes) to 60 minutes||||units on a scale|Migraine attacks|Standard Deviation|Mean
1372253|NCT01542307|Secondary|Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|Baseline (0 minutes) to 15 minutes||||units on a scale|Migraine attacks|Standard Deviation|Mean
1372254|NCT01542307|Primary|Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|From baseline (0 minutes) to 30 mins|Number of migraine attacks treated with Oxygen or Medical Air|||units on a scale|Migraine attacks|Standard Deviation|Mean
1372255|NCT01542255|Secondary|Clinical Response Rate|To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol|Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met.|||||||
1372256|NCT01542255|Primary|Progression Free Survival|Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.|From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||weeks||Full Range|Median
1372257|NCT01542125|Primary|Pain|"A horizontal 100 mm anchored Visual Analogue Scale (0 = no pain, 100 = worst possible pain) was used by the adult caregiver and the orthopedic technician to document the pain associated with Perc Pin removal for participant children.~The Oucher Scale was used to assess pain intensity in participant children and included two separate scales. 6 photographs were assigned scores of 0, 20, 40, 60, 80, and 100 (in increasing increments of pain), such that these would be the scores averaged for participants unable to count by number. Children able to count to 100 by ones or tens and who could identify the larger of 2 numbers used the second scale; a vertical numeric one (0–100) that was printed next to the faces."|Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes||||units on a scale||Standard Deviation|Mean
1372258|NCT01542034|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||units on a scale||Standard Deviation|Mean
1372259|NCT01542034|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.|||percentage of participants|||Number
1372260|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0–4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0–4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
1372261|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0–4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0–4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
1372262|NCT01541969|Secondary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 10' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 36 weeks (visit 10)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 36 weeks (visit 10). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
1372263|NCT01541969|Secondary|Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG)|"Non-invasive recording to measure rhythmic patterns of spontaneous brain activity at rest. An a priori hypothesis targeted normalized delta rhythm. Band powers were calculated as percent change in delta brainwave pattern relative to change in total (1-90 Hz) EEG band. Comparison made between 'visit 2' and 'visit 6'.~We used a Neuroscan system (SynAmps2 model 8050, Compumedics Neuroscan, Charlotte, NC, USA) and custom cap with 66 equidistant scalp electrodes (Easycap, GmbH, Germany). A central frontal electrode was used as ground and a nose-tip electrode as reference. Electrode impedances were maintained at 5 kΩ prior to recordings. Recording was done with an offline filter of 0.5 to 200 Hz pass-band and 1 kHz sampling rate. Recording was over a continuous 10-minute period. Participants were seated in a quiet, darkened soundproof booth and were instructed to relax, keep eyes open and fix gaze on a marker point."|Baseline (visit 2) and 12 weeks (visit 6)|The EEG assessment was offered only to the first 50 participants enrolled at the Nottingham site. We have analyzed only complete case data for the mean change in delta band power from baseline (visit 2) to 12 weeks (visit 6).|||Percent change||Standard Deviation|Mean
1372264|NCT01541969|Secondary|World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)|The WHOQOL-BREF is a 26-item, multi-attribute questionnaire measure of health related quality of life. Outcome was measured as a change on Question 1: 'How would you rate your quality of life (over the past 4 weeks)?' There are 5 response options (Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction in self-perceived quality of life.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in Q1 score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
1372265|NCT01541969|Secondary|Tinnitus Functional Index (TFI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global TFI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
1372266|NCT01541969|Secondary|Tinnitus Handicap Inventory (THI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
1372267|NCT01541969|Primary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
1372268|NCT01541930|Secondary|Pain (Visual Analogue Scale)|The pain linked to the fungating tumour over the last 24 hours was evaluated by the patient. The pain was graded using a 100 mm linear visual analogical scale (graded from 0 mm = no pain to 100 mm = severe pain).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||mm||Standard Deviation|Mean
1372269|NCT01541930|Secondary|Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)|Appearance score was evaluated by the Study Investigator using the following scale; 0: None (No discharge, e.g. frequency of dressing change: once daily), 1: Mild (Dressing need to be Changed twice daily), 2: Moderate (Dressing need to be Changed 3 times daily), 3: Marked (Dressing need to be Changed >3 times daily / Bloody).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
1372270|NCT01541930|Secondary|Smell Score by Patient|Tumour smell score was evaluated by the Patient using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
1372271|NCT01541930|Secondary|Smell Score by Nurse|Tumour smell score was evaluated by the Nurse using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
1372272|NCT01541930|Secondary|Smell Score by Investigator|Tumour smell score was evaluated by the Study Investigator using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell, 3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
1372273|NCT01541930|Primary|The Success Rate|The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator|at Day 14 (end of treatment)|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. Only observed cases were part of the analyses. If the primary endpoint was missing, an additional analysis of this endpoint was performed using the last observation carried forward (LOCF) to impute the missing data.|||percentage of participants||90% Confidence Interval|Number
1372274|NCT01541917|Secondary|Change in Approach Coping|"Scores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale (never use to very often use) and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5."|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
1372275|NCT01541917|Secondary|Change in Children’s Arthritis Self-Efficacy (CASE) Scores|"Confidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale (not at all sure to very sure) are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value."|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
1372276|NCT01541917|Secondary|Change in Disease Activity|Disease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||joints||Standard Deviation|Mean
1372277|NCT01541917|Secondary|Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score|Knowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
1372278|NCT01541917|Primary|Change in PedsQL Rheumatology Health-Related Quality of Life Total Score|Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
1372279|NCT01541917|Primary|Change in Pain Intensity|"Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value (no pain) and 10 being the highest value (very much pain)."|Baseline, post-treatment, 6-month follow-up, 12-month follow-up|All randomized patients were analyzed regardless of whether or not they completed treatment (intent to treat analyses).|||Units on a scale||Standard Deviation|Mean
1372280|NCT01541865|Secondary|Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.|||participants|||Number
1372281|NCT01541865|Secondary|Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||participants|||Number
1372289|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure|Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment.|||mm Hg||Standard Deviation|Mean
1372290|NCT01541865|Secondary|Absence of Flow Limiting Stenosis in the Renal Artery|Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.|||participants w/o flow limiting stenosis|||Number
1372291|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment|Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.|||mm Hg||Standard Deviation|Mean
1372292|NCT01541826|Secondary|Energy-adjusted Vitamin A Intake|Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||retinol equivalent mcg/day||Standard Error|Mean
1372293|NCT01541826|Secondary|Intake of Dietary Antioxidant Capacity|Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||Vitamin C equivalents||Standard Error|Mean
1372294|NCT01541826|Secondary|Polyphenol Intake|Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||mg/day||Standard Error|Mean
1372295|NCT01541826|Secondary|Energy-adjusted Micronutrient Intake|Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||mg/day||Standard Error|Mean
1372296|NCT01541826|Secondary|Energy Intake|Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||kcal/d||Standard Error|Mean
1372297|NCT01541826|Secondary|Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber|Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||g/day||Standard Error|Mean
1372298|NCT01541826|Secondary|Urinary Polyphenol Excretion|Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/mg creatinine||Inter-Quartile Range|Median
1372299|NCT01541826|Secondary|Superoxide Dismutase Activity|Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||units/mL||Standard Error|Mean
1372300|NCT01541826|Secondary|Glutathione Peroxidase Activity|Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||nmol/min/mL||Standard Error|Mean
1372301|NCT01541826|Secondary|Catalase Activity|Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||nmol/min/mL||Standard Error|Mean
1372302|NCT01541826|Secondary|Total Antioxidant Capacity|Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||micrograms vitamin C equivalents/mL||Standard Error|Mean
1372303|NCT01541826|Secondary|P-selectin|Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mL||Standard Error|Mean
1372352|NCT01541254|Secondary|Successful Delivery of the LVIS™ Device Measures by Technical Success|Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.|24 hours|||||||
1372304|NCT01541826|Secondary|Soluble Vascular Cell Adhesion Molecule 1|Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mL||Standard Deviation|Mean
1372305|NCT01541826|Secondary|Intercellular Adhesion Molecule 1|Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mL||Standard Error|Mean
1372306|NCT01541826|Secondary|C-reactive Protein|Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
1372307|NCT01541826|Secondary|Tumor Necrosis Factor-alpha|Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
1372308|NCT01541826|Secondary|Monocyte Chemoattractant Protein-1|Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
1372309|NCT01541826|Secondary|Interleukin-6|Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
1372310|NCT01541826|Secondary|Interleukin-1 Beta|Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
1372311|NCT01541826|Secondary|Adiponectin|Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||micrograms/mL||Standard Error|Mean
1372312|NCT01541826|Secondary|Urinary Excretion of Polyphenols|Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.|0 to 24 h after consumption of extract|Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.|||mg x h/mg creatinine||Standard Error|Mean
1372313|NCT01541826|Secondary|Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.|Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).|0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose|Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.|||micrograms x h/mL||Standard Error|Mean
1372314|NCT01541826|Secondary|LDL Receptor (LDLR) Protein|Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||relative expression (LDLR/β-actin)||Standard Error|Mean
1372315|NCT01541826|Secondary|LDL Receptor (LDLR)|Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Change from baseline at 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||relative expression (LDLR/GAPDH)||Standard Error|Mean
1372316|NCT01541826|Secondary|3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)|Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 wk|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||relative expression (HMGR/GAPDH)||Standard Error|Mean
1372317|NCT01541826|Secondary|Urinary F2-isoprostanes|Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mmol creatinine||Standard Error|Mean
1372318|NCT01541826|Secondary|Resting Diastolic Blood Pressure|Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mmHg||Standard Error|Mean
1372319|NCT01541826|Secondary|Resting Systolic Blood Pressure|Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mmHg||Standard Error|Mean
1372320|NCT01541826|Secondary|Triglycerides|Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
1372321|NCT01541826|Secondary|HDL-cholesterol|Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
1372322|NCT01541826|Secondary|Total Cholesterol|Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
1372323|NCT01541826|Primary|LDL Cholesterol|Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks of intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
1372324|NCT01541735|Primary|Total Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion|Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)||||µU/ml||Standard Deviation|Mean
1372325|NCT01541735|Primary|Second Phase of Insulin Secretion|Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)|Baseline and 45 day||||µU/ml||Standard Deviation|Mean
1372326|NCT01541735|Secondary|Glycated Hemoglobin A1C||Change from Baseline in glycated hemoglobin A1C at 45 day.||||percentage||Standard Deviation|Mean
1372327|NCT01541735|Primary|First Phase of Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.|Change from Baseline at 45 days. (plus or minus 3 days)|The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial|||µU/ml||Standard Deviation|Mean
1372328|NCT01541644|Primary|To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)|The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians & the TNSc in our trial was performed by a research nurse. The reliability & validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.|Baseline and 10 weeks||||units on a scale (1 - 100)||Standard Deviation|Mean
1372329|NCT01541553|Secondary|Partial Clearance of AKs at Week 11|Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11|Week 11||||participants|||Number
1372330|NCT01541553|Secondary|Percentage Change From Baseline in Number of AKs at Week 11|Percentage change from baseline in number of AKs at Week 11|Baseline to week 11||||percentage of change||Standard Deviation|Mean
1372331|NCT01541553|Primary|Complete Clearance of AKs at Week 11|To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.|11 weeks||||participants|||Number
1372332|NCT01541397|Secondary|Plasma Phenylalanine Levels|Plasma phenylalanine levels will be monitored to determine effectiveness of Kuvan therapy.|weekly for 6 weeks, then at least every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
1372333|NCT01541397|Secondary|Diet Analysis|Subjects will provide a 3 day diet record for every plasma amino acid evaluation. Diets will be analyzed to determine phenylalanine, protein, calories, fat, vitamins and minerals.|every 3 months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
1372334|NCT01541397|Secondary|Plasma Amino Acid Profile|Evaluation of levels of plasma amino acids.|every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
1372335|NCT01541397|Primary|Bone Mineral Density|A DXA scan will be conducted one year after Kuvan therapy is initiated.|1 year after initiation of Kuvan therapy|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
1372336|NCT01541384|Primary|Immunosuppression (Tacrolimus) Adherence|"The primary outcome will be the percentage of tacrolimus doses taken as directed during the final 90 days of this 180 day trial as measured by the GlowCap. This includes a 14 day wash-in period for device acclimatization."|90 days||||percentage of correct tacrolimus doses||Standard Deviation|Mean
1372337|NCT01541371|Secondary|Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12|The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."|||mm||Standard Deviation|Mean
1372338|NCT01541371|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."|||Participants|||Number
1372353|NCT01541254|Secondary|Parent Artery Patency Measured Angiographically at 6 Months|To be assessed by Independent Core Lab.|6 months|||||||
1372825|NCT01535326|Secondary|Patient Satisfaction Score|satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied|9 to 12 months||||units on a scale||Full Range|Median
1372339|NCT01541371|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|PSP assesses the degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =<30, functioning so poorly as to require intensive supervision.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
1372340|NCT01541371|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
1372341|NCT01541371|Secondary|Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Percentage of participants with at least 20 percent improvement of PANSS total score was measured.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||Percentage of participants||95% Confidence Interval|Number
1372342|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1372343|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1372344|NCT01541371|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||unit on a scale||Standard Deviation|Mean
1372345|NCT01541358|Secondary|Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy|"Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:~TP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)~The result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT."|an estimated average of 2 hours|Both participants were included in the analysis.|||percentage of sensitivity|||Number
1372346|NCT01541358|Secondary|Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy|"Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.~The calculation for specificity is TN / (TN + FP), where:~TN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage."|an estimated average of 2 hours|Both participants were included in the analysis.|||percentage of specificity|||Number
1372347|NCT01541358|Primary|Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy|F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer.|an estimated average of 2 hours|Includes all study participants.|||lesions detected by F18 NaF|||Number
1372348|NCT01541254|Secondary|Unplanned Embolization Coiling Within 6 Months|If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.|Day 1-6 months|||||||
1372354|NCT01541254|Primary|Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months|A major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥ 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.|30 days-6 months||||patients|||Number
1372355|NCT01541254|Primary|Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)|Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.|6 months ± 4 weeks||||percent occlusion of aneurysm||Standard Deviation|Mean
1372356|NCT01540981|Secondary|Change in Mean Wound Area|Measured from randomization to last visit (14 days or at discharge from hospital)|14 days||||square centimeters||Standard Deviation|Mean
1372357|NCT01540981|Primary|Effectiveness|"To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue).~Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy"|14 days||||participants|||Number
1372358|NCT01540851|Secondary|Range of Motion|Percentage of participants able to bend knee at least 120 degrees|6 months after TKA|Percentage of participants who self-reported on their 6 month questionnaire that they were able to bend their index knee to greater than 120 degrees|||percentage of participants|||Number
1372359|NCT01540851|Secondary|Satisfaction|Percentage of patients in each study arm who reported being very satisfied with the results of TKA|Measured at 6 months post TKA|The proportion of participants who reported being very satisfied with the results of TKA was assessed using a 5-item Likert scale on the 6 month follow-up questionnaire|||percentage of participants|||Number
1372360|NCT01540851|Primary|Change in WOMAC Physical Function|The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months|Change in functional status from baseline to 6 months|The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst. Change in function was calculated as the WOMAC Physical Function score at 6 months minus the WOMAC Physical Function score at baseline|||units on a scale||95% Confidence Interval|Mean
1372361|NCT01540825|Primary|Assessment of Tolerability by the Investigator|Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.|End of study visit, up to day 10|Treated set|||Percentage of participants|||Number
1372362|NCT01540825|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study visit, up to 10 days|Treated set|||Percentage of participants|||Number
1372363|NCT01540825|Secondary|t1/2|Terminal half-life of the analyte in plasma (t1/2)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||Hours||Geometric Coefficient of Variation|Geometric Mean
1372364|NCT01540825|Secondary|AUC0-infinity|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1372365|NCT01540825|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1372366|NCT01540825|Secondary|Tmax|Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||Hours||Full Range|Median
1372367|NCT01540825|Secondary|Cmax|"Maximum measured concentration of the analyte in plasma (Cmax).~The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK."|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1372368|NCT01540825|Primary|Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test|Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test|From administration of study drug until end-of-study visit, up to 10 days|Treated set|||Percentage of participants|||Number
1372369|NCT01540773|Primary|Area Under the Curve of Growth Hormone Over Baseline|Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3||||min*ng/mL||95% Confidence Interval|Mean
1372493|NCT01537900|Primary|Apparent Terminal Hepatic Half-life (t[H]½ ) of GZR|t(H)1/2 is a measure of the time required for the maximum post-dose liver concentration of GZR to decrease by 50%.|4, 8, 24, and 72 hours post-dose on Day 7|Apparent t(h)1/2 could not be estimated due to insufficient data in the terminal phase.||||||
1372370|NCT01540773|Primary|Percent Change of Growth Hormone Over Baseline|Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3||||percentage of change||Standard Deviation|Mean
1372371|NCT01540513|Primary|Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors|Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24-, and 48 hours post injection.|24- and 48 hours post injection|Of 12 participants, 8 had evaluable tumor to blood pool ratio data.|||Ratio of PET SUV||Standard Deviation|Mean
1372372|NCT01540513|Primary|Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake|Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24- and 48 hours post injection.|24- and 48 hours post injection|Of 12 participants, 8 had evaluable TBR data.|||Ratio of PET SUV||Standard Deviation|Mean
1372373|NCT01540513|Primary|Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors|TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24-, and 48 hours post injection.|24- and 48 hours post injection|Of 12 participants, 8 had evaluable TBR data.|||Ratio of PET SUV||Standard Deviation|Mean
1372374|NCT01540513|Primary|Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake|TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24- and 48 hours post injection.|24- and 48 hours post injection|Of 12 subjects, only 8 had evaluable data.|||Ratio of PET SUV||Standard Deviation|Mean
1372375|NCT01540487|Secondary|AUC0-tz for Linagliptin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1372376|NCT01540487|Secondary|AUC(0-infinity) for Metformin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1372377|NCT01540487|Secondary|Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1372378|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Metformin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1372379|NCT01540487|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1372380|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Linagliptin.||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1372381|NCT01540487|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1372382|NCT01540370|Primary|Inter- Examiner Agreement in Angle Width by Goniometric Lens|Inter-rater agreement (among 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)|||Kappa statistics|||Number
1372383|NCT01540370|Primary|Intra- Examiner Agreement in Angle Width by Goniometric Lens|Intra-rater agreement (for each of the 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)|||Kappa statistics|||Number
1372384|NCT01540266|Secondary|Estimates of the Current Status||5 minutes|||||||
1372385|NCT01540266|Secondary|Estimates of the Quality of the Communication||5 minutes|||||||
1372460|NCT01539135|Primary|Number of Participants With Dye Leakage|Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.|Duration of surgical procedure - from 2 to 12 hours||||participants|||Number
1372386|NCT01540266|Primary|Number of Items Recalled From the Communication in the Video|The students in the structured condition and the students in the non-structured condition were independently shown a video in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form. The key memory measure of interest was immediate recall performance expressed as the number of items recalled from the overall 28 items in the two videos. Participants’ recall protocols were evaluated by two independent raters, one of whom rated all protocols and the other, only a subset of them. Analyses of the agreement between the two raters resulted in a Cohen’s kappa of 0.74, indicating substantial interrater reliability according to Landis and Koch (35). In case of disagreement between the two raters, consensus was reached through joint analysis and discussion of the protocols.|5 minutes||||number of items recalled||Standard Deviation|Mean
1372387|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 12 month of life||||participants|||Number
1372388|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 6 month of life||||participants|||Number
1372389|NCT01540162|Primary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 28 days of life||||participants|||Number
1372390|NCT01540045|Primary|Dysgeusia (BITTER Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes|pre - post chemotherapy (6 weeks)||||participants|||Number
1372391|NCT01540045|Primary|Dysgeusia (SWEET Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.|pre - post chemotherapy (6 weeks)|we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy|||participants|||Number
1372392|NCT01540045|Primary|Dysgeusia (UMAMI Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)|pre - post chemotherapy (6 weeks)||||participants|||Number
1372393|NCT01540045|Primary|Dysgeusia (BITTER Recognition)|"Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Median
1372394|NCT01540045|Primary|Dysgeusia (BITTER Perception)|"Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Mean
1372395|NCT01540045|Primary|Dysgeusia (SWEET Recognition)|"Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Median
1372396|NCT01540045|Primary|Dysgeusia (SWEET Perception)|"Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|||μmol/ml||Full Range|Median
1372397|NCT01540045|Secondary|Global Status of Quality of Life (C-30,LC13 EORTC)|"differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste.~score of scale 0-100, a higher score represents better overall state."|time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks||||units on a scale||Inter-Quartile Range|Median
1372398|NCT01540045|Secondary|Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)|comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks||||Units on a scale||Full Range|Median
1372399|NCT01540045|Secondary|Change From Baseline in Albumin After 2 Cycles of Chemotherapy|comparison of patients who increased or decreased their sensibility to the PT of umami taste|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||g/dL||Standard Deviation|Mean
1372400|NCT01540045|Secondary|Quality o f Life|The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||Scores on a scale||Full Range|Median
1372401|NCT01540045|Primary|Dysgeusia (UMAMI Recognition)|"Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|||μmol/ml||Full Range|Median
1372402|NCT01540045|Secondary|IRON Consumption|IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||mg||Standard Deviation|Mean
1372403|NCT01540045|Secondary|PROTEIN AND FAT Consumption|energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||gr||Standard Deviation|Mean
1372404|NCT01540045|Secondary|Subjective Global Assessment|validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).|descriptive values before chemotherapy||||participants|||Number
1372405|NCT01540045|Secondary|Body Mass Index|Body mass index, using the formula kg/m^2|Change from Baseline in threshold of perception and recognition at 6 weeks||||kg/m^2||Standard Deviation|Mean
1372406|NCT01540045|Secondary|BODY COMPOSITION|fat mass and lean body mass pre-post chemotherapy|Change from Baseline in perception and recognition thresholds at 6 weeks||||kg||Standard Deviation|Mean
1372407|NCT01540045|Primary|Dysgeusia (UMAMI Perception)|"Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Median
1372408|NCT01539980|Secondary|Liver Enzyme (AST)|Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased.|Within 14 days after operation||||u/L||Standard Deviation|Mean
1372409|NCT01539980|Secondary|Proinflammatory Cytokines (IL)|The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.|Within 14 days after operation||||pg/mL||Standard Deviation|Mean
1372410|NCT01539980|Secondary|Pain Levels of Wounds|Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.|Within 14 days after operation||||units on a scale||Standard Deviation|Mean
1372411|NCT01539980|Secondary|Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Number of patients with infected wound|Within 14 days after operation||||Number of patients with infected wound|||Number
1372412|NCT01539980|Primary|Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.|Within 14 days after operation||||Days||Standard Deviation|Mean
1372413|NCT01539811|Secondary|Length of Antibiotics|Length of antibiotic|6 weeks|||||||
1372414|NCT01539811|Secondary|Hospital Stay|Length of hospital stay, total cost of hospital stay|2 weeks|||||||
1372415|NCT01539811|Secondary|Clearance of Infection|Clearance of infection (as determined by negative culture, normal complete blood count (CBC), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP)|6 weeks|||||||
1372416|NCT01539811|Secondary|Reinfection/Reintervention|Reinfection or Reintervention to the operative site|3 months|||||||
1372417|NCT01539811|Primary|Wound Healing|Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.|3 months|||||||
1372418|NCT01539759|Secondary|Women's Satisfaction With IUDs||0-6 months postpartum||||percentage of participants satisfied|||Number
1372419|NCT01539759|Secondary|IUD Expulsion||0-6 months postpartum||||participants|||Number
1372420|NCT01539759|Primary|IUD Use|The use of an IUD at 6 months postpartum is the primary outcome measure|6 months postpartum||||participants|||Number
1372470|NCT01539070|Secondary|Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group|We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.|3 months||||participants|||Number
1372517|NCT01537367|Secondary|Mean Counts Per Person (Rates) of Kept Visits.|The rate of kept clinic visits per person over 12 months.|12 months after enrollment||||# kept visits/person/12 months||Standard Error|Mean
1372421|NCT01539642|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326.~Time-weighted SPID48 = ∑ [T(i) – T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours.~Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one active patient receiving placebo inadvertently."|48 hours||||Units on a scale||Standard Error|Least Squares Mean
1372422|NCT01539590|Secondary|Symptoms and Clinical Signs of CHF|Symptoms and clinical signs of CHF measured by NYHA classification|6 months|||||||
1372423|NCT01539590|Secondary|Change in Body Weight||6 months|||||||
1372424|NCT01539590|Secondary|Change From Baseline eCrCl||6 months|||||||
1372425|NCT01539590|Secondary|Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia||6 months|||||||
1372426|NCT01539590|Secondary|All-cause Mortality||6 months|||||||
1372427|NCT01539590|Secondary|Frequency of MACCE||6 months|||||||
1372428|NCT01539590|Secondary|Frequency of AE, SAEs||6 months|||||||
1372429|NCT01539590|Secondary|Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram||6 months|||||||
1372430|NCT01539590|Secondary|Number of Hospitalizations for CHF Through 6 Months||6 months|||||||
1372431|NCT01539590|Secondary|Frequency of New Onset CHF Through 6 Months||6 months|||||||
1372432|NCT01539590|Secondary|Frequency of MACE||6 months|||||||
1372433|NCT01539590|Secondary|Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain||1 and 6 months|||||||
1372434|NCT01539590|Secondary|Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography||1 and 6 months|||||||
1372435|NCT01539590|Secondary|LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography||6 months|||||||
1372436|NCT01539590|Secondary|Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)||6 months|||||||
1372437|NCT01539590|Secondary|Change in Symptoms and Clinical Signs of CHF||6 months|||||||
1372438|NCT01539590|Secondary|Change in BNP Levels||6 months|||||||
1372439|NCT01539590|Secondary|Change in CK-MB and Troponin||6 months|||||||
1372440|NCT01539590|Primary|Evaluation of the Degree of Late Ventricular Remodeling|Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).|6 months|||||||
1372441|NCT01539590|Primary|Evaluation of Reduction in Infarct Size|Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage|6 month|Five subjects were enrolled into the study; 3 subjects were randomized to BB3 and 2 subjects to placebo. Of the 3 subjects randomized to BB3, 1 completed study treatment; all three subjects discontinued the study prematurely. The two subjects randomized to placebo completed study treatment and neither discontinued the study prematurely.||||||
1372442|NCT01539538|Primary|Patient Global Satisfaction|Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control|48 hours||||% patients reporting good or excellent||95% Confidence Interval|Number
1372443|NCT01539525|Secondary|Mean Cost for Each Intervention|The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs|6 months|This outcome was restricted to participants who had a time stamp for their intervention (n=11 were missing) and had all 6 months of follow-up data.|||dollars|participants|Standard Deviation|Mean
1372444|NCT01539525|Secondary|Rates of STDs|rates of incident std's per patient's medical records|baseline to 6 months||||participants|||Number
1372445|NCT01539525|Primary|Treatment Utilization|Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).|baseline to 6 months||||participants|||Number
1372446|NCT01539525|Primary|Days Per Month of Primary Substance Use|Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.|7 non-overlapping monthly intervals from baseline to month 6||||days per month||Standard Deviation|Mean
1372447|NCT01539512|Secondary|Complete Response Rate|Complete response rate was defined as the percentage of participants who achieved a complete response.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.|||percentage of participants|||Number
1372448|NCT01539512|Secondary|Overall Survival|Overall survival was defined as the interval from randomization to death from any cause.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.|||months||95% Confidence Interval|Median
1372449|NCT01539512|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization|||percentage of participants||95% Confidence Interval|Number
1372481|NCT01538615|Primary|Change in Child Body Mass Index (BMI Z-score)|Trained study staff will measure parent and child height and weight and use this to calculate body mass index (BMI). BMI values were than standardized for age and gender using CDC guidelines to obtain BMI z-scores. Analyses controlled for child age and parent education at baseline.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||z-score||Standard Error|Least Squares Mean
1372450|NCT01539512|Secondary|Overall Response Rate|"Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.~Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.~Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors."|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
1372451|NCT01539512|Primary|Progression-Free Survival|Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.|Up to 17 months|Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization.|||months||95% Confidence Interval|Median
1372452|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 3|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 3 (End of Study)|Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days.|||Units on a scale||Inter-Quartile Range|Mean
1372453|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 2|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 2 (Week 4)|Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days.|||Units on a scale||Inter-Quartile Range|Mean
1372454|NCT01539317|Primary|Location of Pain in Postmenopausal Dyspareunia|"To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0=no pain and 10=the worst pain you have ever felt."|Enrollment visit||||units on a scale from 0 to 10||Inter-Quartile Range|Median
1372455|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 1|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 1 (Enrollment)|Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.|||units on a scale||Inter-Quartile Range|Mean
1372456|NCT01539317|Primary|Prevention of Entry Dyspareunia With Non-hormonal Therapy|"Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being no pain and 10 being worst possible pain). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase."|During Phase II (0-4 weeks) and during Phase III (5-12 weeks)||||Units on a scale||Inter-Quartile Range|Mean
1372457|NCT01539135|Secondary|Number of Participants With Unanticipated Intensive Care Unit Admission|Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.|Time from discharge from PACU to discharge from hospital up to 72 hours||||participants|||Number
1372458|NCT01539135|Secondary|Number of Participants With Postoperative Pneumonia|Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery|Up to 30 days after surgery||||participants|||Number
1372459|NCT01539135|Secondary|Length of Hospital Stay|Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.|Time from discharge from PACU to discharge from hospital up to 72 hours||||hours||Standard Deviation|Mean
1372482|NCT01538472|Primary|3-Year Overall Survival|Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.|3 years||||percentage of participants|||Number
1372461|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase|Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.|Baseline, Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.|||units on a scale||Standard Deviation|Mean
1372462|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase|The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).|Baseline, Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.|||units on a scale||Standard Deviation|Mean
1372463|NCT01539083|Secondary|Consolidation Phase: Overall Survival (OS)|OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.|Up to 3 years|All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment.|||months||95% Confidence Interval|Median
1372464|NCT01539083|Secondary|Consolidation Phase: Disease-free Survival (DFS)|DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).|Up to 3 years|Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, ‘N’ (number of participants analyzed) signifies the participants who had complete response.|||months||95% Confidence Interval|Median
1372465|NCT01539083|Secondary|Consolidation Phase: Progression Free Survival (PFS)|PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|Baseline until progressive disease (up to 3 years)|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||months||95% Confidence Interval|Median
1372466|NCT01539083|Secondary|Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12|sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||percentage of participants|||Number
1372467|NCT01539083|Secondary|Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||percentage of participants|||Number
1372468|NCT01539083|Primary|Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours.|Month 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||percentage of participants|||Number
1372469|NCT01539070|Primary|Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment|In order to calculate children’s BMI and age and sex specific BMI z-scores at baseline and 3 month follow-up, study staff assessed child’s height in meters and weight in kilograms. BMI was calculated as weight in kilograms divided by the square of height in meters.|0, 3 month||||z score||Standard Error|Mean
1385421|NCT01402141|Primary|Changes in Histamine-induced Wheal Size|Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||mm^2||Standard Deviation|Mean
1372471|NCT01539070|Primary|Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment|Staff assisted parents in reporting the average time the participating child spent in pre-specified active and sedentary activities during the week and on weekends. For each of the pre-specified activities parents reported time spent in open-ended response format. From these responses we derived total hours/week of physical activity composed of active play (e.g. running, jumping, walking, playing ball, playing in the park, biking, swimming, dancing), as well as total hours/week of screen time, composed of television, DVD/video, and video and computer games.|0, 3 months|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 and to 6 months between the intervention and usual care groups.|||hours/week||Standard Deviation|Mean
1372472|NCT01539070|Primary|Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment|We asked parents about the average number of servings in the week or month the child consumed each food. We constructed grouped diet variables corresponding to food categories : sweet snacks (sugar-sweetened dairy, sugary cereal, cookies, sweet bread, cake, packaged pastries ], caramel pops, candies and chocolates); fast food (hamburgers, pizza, hot dogs, quesadillas, fried tacos, French fries); savory snacks (packaged snack foods, corn or potato chips); fruit (orange, mango, papaya, watermelon, grapes, apple, banana); vegetables (chard, broccoli, jitomate [tomato], nopales [cactus], chayote [squash], spinach, lettuce, zucchini, carrot); sugar-sweetened beverages (soda, flavored milk, homemade [agua fresca] and packaged fruit drinks); and added sugar in beverages (teaspoons sugar or sweet flavoring added to milk, coffee, tea, or fruit juice).|0, 3 months|Intent-to-treat analyses with multiple imputation to account for missing data. Were included in the analysis of children between 0 and 3 BMI z score, age between 24 and 59 months and parents signed letter of consent to participate in the study|||servings/week||Standard Error|Mean
1372473|NCT01538862|Secondary|Overall Improved Symptomatology|Overall clinical improvement in symptomatology and/or findings, as assessed by either the patient or parent. This would include decrease in the number and size of blister and erosions, decreased pain, improved comfort of the patient.|28 days||||Participants|||Count of Participants
1372474|NCT01538862|Secondary|Surface Area of Nonhealing Erosions|Change in surface area of one or two nonhealing erosions|7 days|Time frame was originally entered as 30 days. This was not consistent with the protocol which listed a 7 day time frame for this Outcome|||percentage change||Standard Deviation|Mean
1372475|NCT01538862|Primary|Percent Change of Active Blisters and in Total Blister/Erosion Counts|Percent change of active blisters and in total blister/erosion counts from baseline to 7 days|7 days|Time frame was originally entered as 30 days. This was not consistent with the protocol which listed a 7 day time frame for this Outcome|||percent change||Standard Deviation|Mean
1372476|NCT01538719|Secondary|Change in Modified Rodnan Skin Score|Change in Modified Rodnan Skin Score over time. The fully validated modified version of the Rodnan skin thickness score was used. On this scale, a total of 17 skin sites are evaluated, including the face, upper arms, forearms, dorsum of the hands, fingers, chest, abdomen, thighs, forearms and feet. The total score can range from 0 to 51, with higher scores indicating greater severity of skin thickening and involvement (MRSS-51). Each of the 17 skin sites are scored from 0 to 3, where the following criteria apply: 0, normal skin; 1, thickened skin; 2, thickened and unable to pinch; and 3, thickened and unable to move. Scores from visit 3 (Day 42) and visit 1 (Day 0) were compared.|Visit 3 (Day 42) - Visit 1 (Day 0)||||Units on the Modified Rodnan Skin Score||Full Range|Mean
1372477|NCT01538719|Primary|Change in 2- Gene Biomarker|To investigate the effect of rilonacept on 2-gene biomarker expression in skin after treatment with rilonacept compared to pre-treatment 2-gene biomarker expression. These were measured at visit 3 (Day 42) and visit 1 (Day 0). This was calculated using a previously validated equation (MRSS = −27.6844 + [4.46(baseline THBS1)] + [5.31(ΔMS4A4A) + 4.96(ΔTHBS1)]). In this equation the expression of two genes (THBS1 and MS4A4) in collected samples are measured via nanostring, and then the expression levels of each gene are inserted into the equation in order to obtain the 2- gene biomarker score. A high biomarker score is equivalent to a high skin score, suggesting a higher severity of the disease.|Visit 3 (Day 42) - Visit 1 (Day 0)|Analysis run on 4 available samples in placebo arm.|||2- gene biomarkers score||95% Confidence Interval|Mean
1372478|NCT01538615|Secondary|Change in Number of Fruits and Vegetables Available in the Home|The HOME Food Inventory assesses which foods families currently have in their home from a list of items. Analyses controlled for child age and parent education.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||number of fruits and vegetables||Standard Error|Least Squares Mean
1372479|NCT01538615|Secondary|Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week|Screen time will be measured with survey questions asking children how many hours per day they spend doing each sedentary activity (such as watching TV, using the computer, playing video games). Separate questions will be asked for week days and weekend days then the will be weighted to determine the hours of sedentary activity per week. Analyses controlled for child age and parent education at baseline.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||hours per week||Standard Error|Least Squares Mean
1372480|NCT01538615|Secondary|Change in Target Children's Daily Intakes of Fruits and Vegetables|A trained interviewer will complete three 24-hour dietary recalls at each data collection time point with the child. The three days will be averaged to get an estimate of usual intake. Analyses controlled for child age and parent education at baseline.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||average servings||Standard Error|Least Squares Mean
1372492|NCT01537900|Secondary|Plasma AUC[0-24 hr] of GZR|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
1372483|NCT01538472|Primary|Overall Survival Median|Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.|Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)||||days||Full Range|Median
1372484|NCT01538199|Post-Hoc|Change in Quick Inventory of Depressive Symptomatology-Self Rated Scale (QIDS-SR) Score|This is a brief (16-item) self-report inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. QIDS scores range from 0-27. Severity of depression can be judged based on the total score: 1-5 = No depression, 6-10 = Mild depression, 11-15 = Moderate depression. 16-20 = Severe depression, 21-27 = Very severe depression. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of four t-PBM sessions for inclusion in the study analyses) and treatment completers (participants who were followed for the entire 8-week study period and who received a clinical assessment immediately after). Pilot Study Group 2 excluded because no analyses were completed for this group (see participant flow)|Visit 1 (Baseline) and Visit 17 (Week 9)|Excluded: 3 randomized subjects who had <4 t-PBM treatments; 1 from Group 1 (unreliable reporting); 2 from Group 1 (started new treatment),1 from Group 2 (started therapy). 1 from Pilot study group 1 (no final visit). Pilot Study Group 2 excluded because there was no data (2 subjects dropped out, 1 subject ineligible--see Participant Flow).|||units on a scale||Standard Deviation|Mean
1372485|NCT01538199|Secondary|Number of Participants With Adverse Events|"To assess the safety and tolerability of the TLT in depressed subjects: We predict that the TLT will be safe and well-tolerated by depressed patients, as assessed by the following rating scales: ADVERSE EVENTS FORM. We anticipate no significant differences in between TLT and Sham treatment as concerns side-effects.~Due to the small sample size and the variability of reported adverse events, we decided that descriptive reporting (i.e. reporting each subject's adverse events individually) was more appropriate than analysis. All adverse events were reported in the adverse events section. In the outcome measure data table below we report the number of participants in each group who experienced an adverse event."|Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17|3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments.|||Participants|||Count of Participants
1372486|NCT01538199|Secondary|Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI)|"To assess the safety and tolerability of TLT in depressed subjects: We predict that TLT will be safe and well-tolerated, as assessed by the SAFTEE-SI. We anticipate no significant differences between TLT and Sham in side-effects.The SAFTEE is a commonly used instrument developed by the NIMH and adapted into a self-report instrument. The version we used is the same used by the NIMH-sponsored CO-MED trial. It examines all possible treatment-emergent side effects and adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior.~The SAFTEE analyses are ongoing and will be reported in a second paper (they are not included in the primary outcomes paper). The single value analyzed is the total number of distinct treatment-emergent side-effects (a side effect is defined as any item on the SAFTEE for which severity increased by two or more levels from baseline to any visit) that occurred for each subject. Range: 0 to 165; higher values represent worse outcomes."|Assessed at odd-numbered Visits 1-17. The single value to be analyzed is the number of distinct side effects that occurred at least once during these assessment visits for each subject.|3 subjects excluded from TLT because they received <4 t-PBM treatments.1 excluded from Group 1 due to unreliable reporting.1 Group 1 and 1 Group 2 excluded due to no final visit score.1 excluded from Pilot Study Treatment Group 1 due to no final visit score.Pilot Study Treatment Group 2 excluded due to no data(drop out, post screen ineligibility).|||units on a scale||Standard Deviation|Mean
1372487|NCT01538199|Primary|Change in Hamilton Depression Rating Scale (HAM-D 17) Score|"We anticipate that TLT will decrease HAM-D17 scores in study subjects significantly more than Sham treatment. We expect that we will be also able to estimate the effect size of the antidepressant action of TLT. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of 4 t-PBM sessions for inclusion in the study analyses) and treatment completers (participants followed for the entire 8-week study period and who received a clinical assessment immediately after).~HAM-D17 questions are rated on a scale of 0-4 or 0-2 (total score: 0-50) with higher scores indicating more severe pathology. Scores typically fall into the following ranges: not depressed = 0-7; mildly depressed = 8-13; moderately depressed = 14-18; severely depressed = 19-22; very severely depressed = 23 and over.~For the pilot study, we analyzed subjects from Baseline to Week 8. A last observation carried forward (LOCF) was performed to account for one week 8n missing value."|Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8|3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments. 2 study completers from Group 1(last visit out of window,started new treatment ),1 subject from Group 2(started therapy)excluded as completers in analyses. Pilot Study Treatment Group 2 excluded because there was no data(drop out, post screen ineligibility).|||units on a scale||Standard Deviation|Mean
1372488|NCT01537900|Secondary|Plasma t½ of GZR|t1/2 is a measure of time for the maximum plasma concentration of GZR to decrease by 50%.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
1372489|NCT01537900|Secondary|Time to Maximum Plasma Concentration (Tmax) of GZR|Tmax is a measure of time to reach maximum post-dose plasma drug concentration.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
1372490|NCT01537900|Secondary|Lowest Plasma Concentration (Ctrough) of GZR|Ctrough is a measure of drug concentration 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
1372491|NCT01537900|Secondary|Maximum Plasma Concentration (Cmax) of GZR|Cmax is a measure of the maximum plasma concentration post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
1372826|NCT01535326|Secondary|Patient Pain Score|The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)|9 to 12 months||||units on a scale||Full Range|Median
1372494|NCT01537900|Primary|Hepatic Concentration of GZR (C[H]Xhr)|C(H)Xhr of GZR was expressed as liver concentration (μmol GZR/L liver) using the concentration of the extracted liver sample (mass of the liver biopsy/0.2 mL solvent), and assuming that liver has the specific gravity of water (1 g/mL). The arithmetic mean C(H)Xhr concentration is based on the means of 4 FNA passes per participant in all 4 participants.|4, 8, 24, and 72 hours post-dose on Day 7|The PPP includes all participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment.|||µM||Standard Deviation|Mean
1372495|NCT01537900|Primary|Estimated Area Under the Liver Concentration-time Curve for 24 Hours Post-dose (AUC[H]0-24hr) of Grazoprevir|Each participant was assigned to undergo Fine Needle Aspiration (FNA) to obtain liver tissue at different time points. Specifically, one participant underwent FNA at 4 hr post-dose only, another participant underwent FNA at 8 hr post-dose only, and a third participant underwent FNA at 24 hr post-dose only. (The fourth participant underwent FNA at 72 hr post-dose and therefore was not included in the calculation of AUC0-24hr.) Therefore, in calculating AUC0-24hr, there were only 3 data points: 1 data point at 4 hr post-dose, 1 data point at 8 hr post-dose, and 1 data point at 24 hr post-dose. The model assumed that drug concentration was at steady-state, and that the concentration at 24 hr post-dose was equal to the concentration at 0 hr post-dose.|4, 8, and 24 hours post-dose on Day 7|The per protocol population (PPP) includes all participants (4, 8, and 24 hr time points) who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment. As each data point was obtained from unique participants, there is no measure of variability.|||µM*hr|||Number
1372496|NCT01537835|Secondary|Assess for Methicillin Resistent Staphylococcus Aureus, Vancomycin Resistant Enterococci, and Gram-negative Bacterial Contamination on Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform.|Number of healthcare workers with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and resistant gram-negative bacteria on the three scrub types, all obtained after the eight-hour workday.|8 hours|Healthcare workers randomized to one of three types of uniform|||participants|||Number
1372497|NCT01537835|Primary|Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.|Total bacterial colony count of samples obtained from the breast or lower front pocket, the sleeve cuff of the dominant hand and the pant leg at the mid-thigh of the dominant leg on all scrubs after an eight-hour workday.|8 hours|healthcare workers randomized to one of three types of uniform.|||colony formation units||Inter-Quartile Range|Median
1372498|NCT01537783|Primary|Recurrence of Cutaneous Abscess|A patient's description that they have had another abscess since their index emergency department visit.|6 months||||Participants|||Count of Participants
1372499|NCT01537666|Secondary|Lung Pharmacokinetics - Minimum Sputum Concentration (Cmin)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.~Cmin is the minimum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.|||µg/ml||Standard Deviation|Mean
1372500|NCT01537666|Secondary|Lung Pharmacokinetics - Maximum Sputum Concentration (Cmax)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.~Cmax is the maximum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.|||µg/ml||Standard Deviation|Mean
1372501|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUCinf)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~AUCinf is a way of estimating the total amount of drug exposure over an infinite time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||h*ng/ml||Standard Deviation|Mean
1372502|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~AUCt is a way of expressing the total amount of drug exposure over a specified time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||h*ng/ml||Standard Deviation|Mean
1372503|NCT01537666|Secondary|Plasma Pharmacokinetics - Maximum Plasma Concentration (Cmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Cmax is the maximum observed concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||ng/ml||Standard Deviation|Mean
1372504|NCT01537666|Secondary|Plasma Pharmacokinetics - Time to Reach the Maximum Plasma Concentration (Tmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Tmax is the time it takes to reach the maximum plasma concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||Hours||Standard Deviation|Mean
1372827|NCT01535326|Primary|Proportion of Patients Without Pain|proportion of patients without insertion pain during colonoscopy|up to 12 months||||participants|||Number
1372505|NCT01537666|Secondary|Plasma Pharmacokinetics - Elimination Half Life (t½)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Half-life is the time it takes for the concentration of drug to decline by 50%."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||Hours||Standard Deviation|Mean
1372506|NCT01537666|Primary|Safety and Tolerability - Number of Participants With Treatment Emergent Adverse Events (TEAEs = Adverse Events That Started During or After the First Dose of Study Drug)|Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: “How do you feel?” or “Have you had any (other) medical problems since your last visit/assessment?” Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable.|Healthy volunteers = 2 weeks; CF Patients = 1 week|All 18 healthy volunteers who received single doses of AeroVanc, 6 of which also received a single dose of IV vancomycin. All 7 Cystic Fibrosis patients who received at least one single dose of AeroVanc.|||participants|||Number
1372507|NCT01537549|Secondary|Cerebral Oxidative Stress Markers|changes of cerebral lactate and glutathione levels as determined by magnetic resonance spectroscopy|at baseline and at week 5|per Protocol|||Ratio||Standard Deviation|Mean
1372508|NCT01537549|Primary|Adverse Events|Incidence and severity of adverse events|at 25 weeks|ITT|||Number of Adverse Events|||Number
1372509|NCT01537432|Secondary|Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52|"Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient’s lesional skin biopsy was scored for the degree of histological improvement compared to that patient’s baseline disease on a five point scale; -~1 (worse) to +3 (excellent). Histological disease reversal or “excellent improvement” (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Week 52|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.|||percentage of participants|||Number
1372510|NCT01537432|Primary|Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12|"Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient’s lesional skin biopsy was scored for the degree of histological improvement compared to that patient’s baseline disease on a five point scale; -~1 (worse) to +3 (excellent). Histological disease reversal or “excellent improvement” (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Baseline, Week 12|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.|||percentage of participants|||Number
1372511|NCT01537419|Secondary|Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and End of Treatment|The Self-Report of Family Functioning consists of 10 items selected from a number of well-known family assessment measures (Family Environment Scale, Family Concept Q-Sort, Family Adaptability and Cohesion Scale, and Family Assessment Measure). The scale ranges from 10 to 40, with a score of 10 being representative of no family conflict and a score of 40 being representative of the greatest magnitude of family conflict. Therefore, a decrease in score represents and decrease in self-reported family conflict.|16 weeks (end of treatment)||||units on a scale||Standard Deviation|Mean
1372512|NCT01537419|Primary|Change in the Severity of Depression Symptoms Between Intake and End of Treatment|Beck Depression Inventory-II. The second edition of the BDI is a widely-used, 21-item self-report instrument designed to assess the severity of depressive symptoms in adults and adolescents. The BDI-II has 21 items and takes approximately 5 minutes to complete. The scale ranges from 0 to 63, with a higher score being representative of a greater clinical magnitude of depression: a total score of 0-13 is considered minimal depression, 14-19 is mild depression, 20-28 is moderate depression, and 29-63 is severe depression.|16 weeks (end of treatment)||||units on a scale||Standard Deviation|Mean
1372513|NCT01537419|Primary|Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment|The Suicidal Ideation Questionnaire-JR is a 15-item self-report assessment. It is based on Reynolds’ theoretical notion of suicidality forming a continuum ranging from thoughts of death, thoughts of wanting to be dead, general and specific suicidal plans, preparations for carrying out plans, and actual suicide attempts. The scale ranges from 0 to 90, with a score of 0 being representative of no suicidal ideation, and a score of 31 or greater indicating severe suicidal ideation.|16 weeks (end of treatment)||||units on a scale||Standard Deviation|Mean
1372514|NCT01537393|Primary|Endothelial Cell Density (ECD)|Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.|3 years from surgery|Eyes with graft success and a gradable image at 3 year (945 eyes of 769 unique participants)|||Cells per square millimeter|eyes|Standard Deviation|Mean
1372515|NCT01537393|Primary|Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery|"Graft failure, defined as the occurrence of one of the following within 3 years of surgery:~Regrafting of the study eye for any reason~Cornea which remains cloudy without clearing, according to the following:~cloudy cornea on the first postoperative day which does not clear within 8 weeks OR~cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing."|Study eye will be assessed for this outcome for 3 years following surgery|Analyzed number of eyes in each group (Overall 1090 unique participants)|||Eyes|Eyes||Count of Units
1372516|NCT01537367|Primary|The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure).|Primary care visits are scheduled appointments for HIV-positive patients to see a physician, nurse practitioner, or physician assistant (a provider who can prescribe medication) at the HIV clinic.|12 months after enrollment|Intention to Treat (ITT)|||Percentage of Pt kept visits/#scheduled|||Number
1372518|NCT01537367|Primary|The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)|Kept visits for each patient were assessed in 4-month periods over the 12 months of the intervention. This is a binary measure, requiring attendance at least once in each of the three 4-month periods.|12 months after enrollment|Intention to Treat (ITT)|||percent in care each 4 month period|||Number
1372519|NCT01537315|Primary|Change From Baseline in Inflammatory Marker, Hs-C Reactive Protein, at 6 Months|Hs-CRP will be measured at baseline (before study drug) and at end of study (6 months). This marker is measured by ELISA assay from serum.|Baseline and 6 months||||ng/ml||Standard Deviation|Mean
1372520|NCT01537302|Secondary|Contrast/Flush Volumes|Evaluation of the contrast/flush volumes.|Day 0|||||||
1372521|NCT01537302|Secondary|Use of Assist Devices|Evaluation of the use of assist devices.|Day 0|||||||
1372522|NCT01537302|Secondary|Crossing Times|Evaluation of crossing times.|Day 0|||||||
1372523|NCT01537302|Secondary|Fluoroscopic Times|Evaluation of fluoroscopic times.|Day 0|||||||
1372524|NCT01537302|Secondary|Procedural Times|Evaluation of procedural times.|Day 0|||||||
1372525|NCT01537302|Secondary|Device Performance|Device performance as assessed by Investigator’s input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO.|Day 0|||||||
1372526|NCT01537302|Secondary|Technical Success|Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.|Day 0|201 Enrolled|||participants|||Number
1372527|NCT01537302|Secondary|Procedural Success|Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.|Day 0|201 Enrolled|||participants|||Number
1372528|NCT01537302|Primary|Primary Efficacy Endpoint|Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.|Day 0|201 Enrolled|||participants|||Number
1372529|NCT01537302|Primary|Primary Safety Endpoint|No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.|Day 30|201 Enrolled, 2 Not Completed, 199 Analyzed|||participants|||Number
1372530|NCT01537198|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)|An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.|From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis||||participants|||Number
1372531|NCT01537185|Secondary|Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG|• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.|28, 56 and 84 days following initial vaccination|only subjects with both baseline and day 84 samples were included in the analysis.|||participants|||Number
1372532|NCT01537185|Primary|Unsolicited Adverse Event Reports|"Safety and Tolerability assessed by cohort and product received measured by:~•Number of unsolicited AEs within four weeks after each vaccination"|within 1 week (0-7 days) following each vaccinations||||participants|||Number
1372533|NCT01537133|Primary|Microbial Community Evenness|Pielou’s evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.|||Pielou’s evenness index||Inter-Quartile Range|Median
1372534|NCT01537133|Primary|Microbial Community Diversity|The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = −Σ p_i log(p_i).|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.|||Shannon Diversity Index||Inter-Quartile Range|Median
1372535|NCT01537133|Primary|Microbial Community Richness|Richness is the total number of different bacterial taxa detected in the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.|||number of bacterial taxa||Inter-Quartile Range|Median
1372536|NCT01537120|Secondary|HbA1C At 12 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.|||HbA1c (%)||Standard Deviation|Mean
1372537|NCT01537120|Secondary|Hemoglobin A1C (HbA1C) At 2 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.|||HbA1c (%)||Standard Deviation|Mean
1385422|NCT01402128|Secondary|Changes in Subcutaneous Adipose Tissue|Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||cm^3||Standard Deviation|Mean
1372538|NCT01537120|Primary|24 Hour Weighted Mean Glucose (WMG) At 2 Weeks|The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
1372539|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 5|Modified Intent-to-Treat(i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 5 are included.|||units on a scale||Standard Deviation|Mean
1372540|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 4|Modified Intent-To-Treat (i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 4 are included.|||units on a scale||Standard Deviation|Mean
1372541|NCT01537068|Secondary|Response Rate|Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.|12 weeks||||Participants|||Count of Participants
1372542|NCT01537068|Primary|Hamilton Rating Scale for Depression (HDRS24)|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Week 12||||units on a scale||Standard Deviation|Mean
1372543|NCT01537068|Primary|Hamilton Rating Scale for Depression (HDRS24)|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Baseline||||units on a scale||Standard Deviation|Mean
1372544|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372545|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372546|NCT01537042|Secondary|Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period|"The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL).~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||scores on a scale||Standard Deviation|Mean
1372567|NCT01536704|Secondary|Elimination Rate Constant for Plasma Nicotine: K (el)|Kel was calculated with the help of plasma time concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||1/hr||Full Range|Median
1372547|NCT01537042|Secondary|Change From Baseline in Sleep Efficiency to the End of the Maintenance Period|"Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep.~A postive value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||sleep time/ total time in bed||Standard Deviation|Mean
1372548|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period|"The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||movement per hour||Standard Deviation|Mean
1372549|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372550|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372551|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372552|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372553|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372554|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372555|NCT01537042|Secondary|Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score|The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill).|Visit 2 (Baseline); Visit 6 (End of Maintence Period)|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||participants|||Number
1372556|NCT01537042|Secondary|Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period|"The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated.~A negative value in Change from Baseline indicates an improvement from Baseline in IRLS."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
1372557|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period.|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||movement/ hour||Standard Deviation|Mean
1372558|NCT01537042|Primary|Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)|"The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG).~The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline].~A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||ratio||95% Confidence Interval|Least Squares Mean
1372559|NCT01537029|Primary|Clearance (Cl) for Doxorubicin and Cyclophosphamide|Cyclophosphamide analysis was not possible due to rapid drug degradation|0-48 hours||||L/hr||Full Range|Median
1372560|NCT01536951|Primary|Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)|The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion and 30-day follow-up|Enrolled participants who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo) during the study.|||Participants|||Count of Participants
1372561|NCT01536951|Primary|Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104||Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug|Randomized participants who received at least 1 dose of LY3009104 and had a predose and at least 1 postdose blood draw for AUC assessment.|||hours*nanomoles per liter (h*nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1372562|NCT01536951|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104||Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug|Randomized participants who received at least 1 dose of LY3009104.|||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1372563|NCT01536951|Primary|Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period [-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.|Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose|Participants enrolled in Part B of the study who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo).|||milliseconds (msec)||Standard Deviation|Mean
1372564|NCT01536938|Primary|Subjects With ‘Controlled Disease’ (‘Clear’/‘Almost Clear’ for Subjects w. at Least Moderate Disease at Baseline, ‘Clear’ for Subjects With Mild Disease at Baseline) According to the Investigator’s Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks||||participants|||Number
1372565|NCT01536886|Primary|Subjects With ‘Controlled Disease’ (‘Clear’/‘Almost Clear’ for Subjects w. at Least Moderate Disease at Baseline, ‘Clear’ for Subjects With Mild Disease at Baseline) According to the Investigator’s Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks||||participants|||Number
1372566|NCT01536860|Primary|Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products|The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.|0-120 minutes||||mmol*min/L||Standard Error|Mean
1372568|NCT01536704|Secondary|Apparent Elimination Half-life of Nicotine T(1/2)|T(1/2) was calculated using plasma time-concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||hr||Full Range|Median
1372569|NCT01536704|Secondary|Time to Reach Maximum Plasma Nicotine Concentration (Tmax)|Tmax was time at which Cmax of nicotine was reached.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||hr||Full Range|Median
1372570|NCT01536704|Secondary|AUC [0-infinity (Inf)]|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||ng.hr/mL||Standard Deviation|Mean
1372571|NCT01536704|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)]|Cmax was depicted from plasma concentration of nicotine.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||ng/mL||Standard Deviation|Mean
1372572|NCT01536704|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]|AUC(0-t) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||nanogram (ng).hour (hr)/millilitre (mL)||Standard Deviation|Mean
1372573|NCT01536587|Secondary|Arterial Stiffness at Baseline (Week 0) and at Week 4|Arterial stiffness occurs as a consequence of age and arteriosclerosis. Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. PWV was evaluated in terms of meters per second (m/s). PWV after salmeterol inhalation at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after inhalation of salmeterol) was assessed.|Baseline and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||m/s||Standard Deviation|Mean
1372574|NCT01536587|Secondary|Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4|Diastolic dysfunction refers to the decline in performance of one (usually the left ventricle) or both (left and right) ventricles during diastole. The number of participants with diastolic dysfunction on echocardiography was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
1372575|NCT01536587|Secondary|Lung Function (Forced Vital Capacity [FVC], Functional Residual Capacity [FRC; Body and Helium], Total Lung Capacity [TLC], and Residual Volume [RV]) at Baseline (Week 0) and at Week 4|FVC is defined as the volume of air that can be forcibly blown out from the lungs after a full inspiration. FRC is defined as the volume of air present in the lungs, specifically the parenchyma tissues, at the end of a passive expiration. TLC is defined as the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to VC plus the RV and is approximately 5800 milliliters. RV is defined as the amount of gas remaining in the lungs at the end of a maximal exhalation. All parameters describing lung function are expressed in terms of liters (L). Lung function (FVC, FRC [body and helium], TLC, and RV) was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||L||Standard Deviation|Mean
1372576|NCT01536587|Secondary|Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4|Transcutaneous carbon dioxide monitoring is a noninvasive way of continuously measuring the tension of these gases in the skin. This methodology provides a continuous noninvasive estimation of the arterial CO2 value. Change in tCO2 after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population. Only those participants available at the indicated time points were assessed.|||mmHg||Standard Deviation|Mean
1372577|NCT01536587|Secondary|Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. Change in SpO2 after salmeterol inhalation is expressed in terms of percent. Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population: all participants included in the study who received at least one dose of study medication. Only those participants available at the indicated time points were assessed.|||percent||Standard Deviation|Mean
1372578|NCT01536587|Secondary|Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (BNP) after salmeterol inhalation is expressed in terms of picograms per milliliter (pg/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||pg/mL||Standard Deviation|Mean
1372666|NCT01536405|Primary|Geometric Mean Titer (GMT) of Rubella Virus Antibodies|Sera were tested for rubella virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results|||IU/mL||95% Confidence Interval|Geometric Mean
1372579|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma epinephrine) after salmeterol inhalation is expressed in terms of nanograms per milliliter (ng/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ng/mL||Standard Deviation|Mean
1372580|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma norepinephrine) after salmeterol inhalation is expressed in terms of nanogramms per liter (ng/L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ng/L||Standard Deviation|Mean
1372581|NCT01536587|Secondary|Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4|Respiratory minute volume is defined as the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. Change in respiratory minute volume after salmeterol inhalation is expressed in terms of milliliters per minute (mL/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||mL/min||Standard Deviation|Mean
1372582|NCT01536587|Secondary|Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4|Tidal volume is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 milliliters or 7 milliliters per kilogram of body weight). Change in tidal volume after salmeterol inhalation is expressed in terms of milliliters (mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||mL||Standard Deviation|Mean
1372583|NCT01536587|Secondary|Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4|Respiratory rate is defined as the number of breaths taken within a set amount of time (typically within 60 seconds). Change in respiratory rate after salmeterol inhalation is expressed in terms of respiratory rate (breaths) per minute (min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||breaths per minute||Standard Deviation|Mean
1372584|NCT01536587|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4|Systolic and diastolic BP was manually measured. Change in BP after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||mmHg||Standard Deviation|Mean
1372585|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||L||Standard Deviation|Mean
1372586|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||L||Standard Deviation|Mean
1372612|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.|From the start of treatment (Baseline) up to Week 25|Safety Population|||Participants|||Number
1372587|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||ms/mmHg||Standard Deviation|Mean
1372588|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ms/mmHg||Standard Deviation|Mean
1372589|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||beats per minute (bpm)||Standard Deviation|Mean
1372590|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||beats per minute (bpm)||Standard Deviation|Mean
1372591|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency Power (HF) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||percent change||Standard Deviation|Mean
1372592|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||percent change||Standard Deviation|Mean
1372593|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||percent change||Standard Deviation|Mean
1372594|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||percent change||Standard Deviation|Mean
1372595|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms^2||Standard Deviation|Mean
1372596|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms^2||Standard Deviation|Mean
1372597|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (N-N) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation), respectively.|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms^2||Standard Deviation|Mean
1372598|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline were calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms^2||Standard Deviation|Mean
1372599|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms||Standard Deviation|Mean
1372600|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms||Standard Deviation|Mean
1372601|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms||Standard Deviation|Mean
1372602|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate variability (HRV) refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms||Standard Deviation|Mean
1372644|NCT01536496|Secondary|Change in Platelet Count Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||k/uL||Inter-Quartile Range|Median
1372603|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per minute (bursts/minute). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||Bursts/minute||Standard Deviation|Mean
1372604|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per minute [bursts/minute]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population|||Bursts/minute||Standard Deviation|Mean
1372605|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per 100 heart beats (bursts/100 heart beats). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||Bursts/100 heart beats||Standard Deviation|Mean
1372606|NCT01536587|Primary|Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats [bursts/100 heart beats]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population: all participants who received at least one dose of study medication and who had a valid data registration period of the primary endpoint.|||Bursts/100 heart beats||Standard Deviation|Mean
1372607|NCT01536574|Secondary|Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||Scores on a scale||Standard Deviation|Mean
1372608|NCT01536574|Secondary|Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe.|Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.|||Scores on a scale||Standard Deviation|Mean
1372609|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population|||Participants|||Number
1372610|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population|||Participants|||Number
1372611|NCT01536574|Primary|Number of Participants With an Adverse Event During the Follow-up Phase|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population|||Participants|||Number
1372645|NCT01536496|Secondary|Change in Fibrinogen Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||mg/dL||Inter-Quartile Range|Median
1372613|NCT01536574|Primary|Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|From the start of treatment (Baseline) up to Week 25|Safety Population: all participants who received at least one dose of study drug|||Participants|||Number
1372614|NCT01536561|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||G/dL||Full Range|Median
1372615|NCT01536561|Secondary|Nadir Values for the Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.|||1000 cells/millimeters cubed (mm^3)||Full Range|Median
1372616|NCT01536561|Secondary|Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters|Time to recovery to baseline is the time required for recovery from nadir values to baseline values.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.|||days||95% Confidence Interval|Median
1372617|NCT01536561|Secondary|Time to Nadir for the Indicated Hematologic Laboratory Parameters|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.|||days||Full Range|Median
1372618|NCT01536561|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||participants|||Number
1372619|NCT01536561|Secondary|Time to HAMA Positivity From the First Dosimetric Dose (Time From Baseline [Dosimetric Dose] to the First Reported Presence of HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.|||days||Full Range|Median
1372620|NCT01536561|Secondary|Number of Participants Who Developed Human Anti-mouse Antibodies (HAMA Postivitiy) After Receiving Tositumomab|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.|||participants|||Number
1372621|NCT01536561|Secondary|Volume of Distribution at Steady State (Vss) of I 131 TST for the Indicated Antibody Predose Levels|Vss is defined as the volume of distribution of the drug at steady state.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||liters|infusions|Standard Deviation|Mean
1372646|NCT01536496|Secondary|Change in INR Test Results.|A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|Within first 6 hours post-injury, 12 and 24 hours post-injury.||||units on a scale||Inter-Quartile Range|Median
1372622|NCT01536561|Secondary|Maximum Blood Concentration (Cmax) of I 131 TST for the Indicated Antibody Predose Levels|Cmax is defined as the maximum observed concentration of the drug in blood.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||% Injected Dose per milliliter (%ID/mL)|infusions|Standard Deviation|Mean
1372623|NCT01536561|Secondary|Area Under the Concentration Time Curve (AUC) of I 131 TST for the Indicated Antibody Predose Levels|Area under the concentration-time curve from the end of the infusion extrapolated to infinite time. AUC measures how much drug is in the system over time after infusion. ID, injected dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||%ID * hours per milliliter (%ID.hr/mL)|infusions|Standard Deviation|Mean
1372624|NCT01536561|Secondary|Clearance (CL) of I 131 TST for the Indicated Antibody Predose Levels|Clearance is defined as the volume of blood from which drug is removed per unit time and is a measure of the rate at which drug is removed from the body after the dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||Milliliters per hour (mL/hr)|infusions|Standard Deviation|Mean
1372625|NCT01536561|Secondary|Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model . t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model; also denoted as t1/2. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||hours (hr)|infusions|Standard Deviation|Mean
1372626|NCT01536561|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
1372627|NCT01536561|Secondary|Time to Progression of Disease or Death|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who experienced progression were evaluated.|||months||95% Confidence Interval|Median
1372628|NCT01536561|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants with unconfirmed response (CR, CCR, or PR) and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
1372629|NCT01536561|Secondary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1372630|NCT01536561|Secondary|Number of Participants (Par.) With the Indicated Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
1372647|NCT01536496|Secondary|Time to Death From Injury in Hours.||From time of injury to 28th day of hospitalization.||||hours||Inter-Quartile Range|Median
1372648|NCT01536496|Secondary|Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).||Up to 28 days post-injury.||||deaths|||Number
1372649|NCT01536496|Secondary|Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).||Within 24 hours post-injury.||||deaths|||Number
1372650|NCT01536496|Primary|28 Day In-hospital Mortality||28 days in hospital||||participants|||Number
1375077|NCT01509040|Secondary|Clearance of Inflammatory Mediators|Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.|48 hours|The outcome was not assessed.||||||
1372631|NCT01536561|Secondary|Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)|The effect of unlabeled TST pre-treatment on targeting of radioactive TST was evaluated. Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose (DD) and then daily for at least 5 days. Initially, participants received either two or three DDs, each of which was preceded by a pre-dose of unlabeled tositumomab (0, 95, or 475 mg) to determine the dose of unlabeled tositumomab that optimized the radiation dose to tumor. The tumor radiation absorbed dose was determined using gamma camera images.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Participants who received unlabelled doses of 0 mg, 95 mg, or 475 mg were analyzed. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ."|||cGy/75 cGy TBD|dosimetric doses|Standard Deviation|Mean
1372632|NCT01536561|Primary|Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)|Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose and then daily for at least 5 days. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). Spleen volume may vary based on disease status, and volume correction allows for a comparison of spleen dose across participants.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ depending on whether adequate gamma camera images were available for analysis after each of the 86 DD."|||cGy/75 cGy TBD|dosimetric doses|Standard Deviation|Mean
1372633|NCT01536561|Primary|Maximum Tolerated Dose (MTD) of TST/I 131 TST Evaluated in the Study|Participants who had prior bone marrow transplantation (BMT) initiated TD at 65 cGy TBD, whereas those who had no prior BMT initiated TD at 25 cGy TBD. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||Total body radiation dose in cGy|||Number
1372634|NCT01536561|Primary|Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)|Retreatment was administered to participants either at the initial TD of TST/I 131 TST or at a reduced dose if a >=Grade 2 toxicity had occurred after initial treatment, until the MTD was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 participants experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no participants were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||participants|||Number
1372635|NCT01536561|Primary|Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)|Par. (groups of 3-6) received the TD at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (par. who had bone marrow transplantation), increasing by 10 cGy increments at each dose level, until the maximum tolerated dose (MTD) was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced dose-limiting toxicity (DLT): any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug.|||participants|||Number
1372636|NCT01536496|Secondary|Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.|Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.|Up to 30 days post-injury.||||participants|||Number
1372637|NCT01536496|Secondary|Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.||28 days.||||days||Inter-Quartile Range|Median
1372638|NCT01536496|Secondary|Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury|Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.|24 hours post-injury||||units||Inter-Quartile Range|Median
1372639|NCT01536496|Secondary|Change in r-TEG LY30 Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||percent of clot lysis at 30 min.||Inter-Quartile Range|Median
1372640|NCT01536496|Secondary|Change in r-TEG Maximal Amplitude (MA) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||mm||Inter-Quartile Range|Median
1372641|NCT01536496|Secondary|Change in r-TEG Angle Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||degrees||Inter-Quartile Range|Median
1372642|NCT01536496|Secondary|Change in r-TEG ACT (Activated Clotting Time) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||seconds||Inter-Quartile Range|Median
1372643|NCT01536496|Secondary|Change in D-dimer Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||ug/mL||Inter-Quartile Range|Median
1372651|NCT01536418|Secondary|Pharmacogenetic Analyses|Sample for the pharmacogenetic analyses was collected during any one of the Treatment Phase visit (Week 2, 4, 6, or 8 ). The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data was not collected for this outcome measure.|Post randomization any time during early two weeks|ITT population.||||||
1372652|NCT01536418|Secondary|Pharmacokinetics (PK) of GSK1605786A|The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A, in the participant population. PK is defined as the concentration of drug in a participant’s blood at certain time points after the drug was taken by mouth. PK sampling was to be conducted at week 2, 4, 6 ,8, 10 and week 12 (pre-dose, post-dose 0.5 hour (hr) to 2 hr, 3 to 6 hr, and 6 to 28 hr post-dose. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus the data for this outcome measure was not collected.|Baseline (Screening) and Week 12|The PK population consisted of the participants having received investigational product (i.e., participants in the Safety population) and for whom a sample was obtained and analyzed.||||||
1372653|NCT01536418|Secondary|Change From Baseline in Faecal Calprotectin at Week 12|Stool samples were planned to be collected for the measurement faecal calprotectin level at Baseline (Screening) and Week 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.|Baseline (Screening) and Week 12|ITT Population.||||||
1372654|NCT01536418|Secondary|Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12|Blood samples were planned to be collected for the measurement of C-reactive protein at Baseline (Screening) and at Weeks 4, 8, and 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time points (Week 4, week 8 and week 12) minus the value at Baseline respectively. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.|Baseline (Screening) and Weeks 4, 8, and Week 12|ITT Population.||||||
1372655|NCT01536418|Secondary|Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12|Clinical response, defined as decrease in Crohn’s disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn’s disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn’s disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using “no effect” imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.|Both Week 8 and Week 12|ITT population|||Percentage of participants|||Number
1372656|NCT01536418|Secondary|Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12|Clinical remission is defined as a CDAI score of <150 points. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn’s disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn’s disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using “no effect” imputation where missing was no response or no change in response (were non-responders). If the Baseline value was <150, the participant was not considered to have achieved remission.|Week 8 and Week 12|ITT population|||Percentage of participants|||Number
1372657|NCT01536418|Primary|Percentage of Participants Achieving Clinical Response at Week 12|Clinical response, defined as decrease in Crohn’s disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn’s disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn’s disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using “no effect” imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder.|At Week 12|The Intent-to-Treat (ITT) population comprised of all participants who have satisfied the eligibility criteria and were assigned with study medication.|||Percentage of participants|||Number
1372658|NCT01536405|Secondary|Percentage of Participants With an Injection-site Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.|Up to 5 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1372659|NCT01536405|Secondary|Percentage of Participants With Varicella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1372660|NCT01536405|Secondary|Percentage of Participants With Rubella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
1372667|NCT01536405|Primary|Geometric Mean Titer (GMT) of Mumps Virus Antibodies|Sera were tested for mumps virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results|||Mumps Ab units/mL||95% Confidence Interval|Geometric Mean
1372668|NCT01536405|Primary|Geometric Mean Titer (GMT) of Measles Virus Antibodies|Sera were tested for measles virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results|||mIU/mL||95% Confidence Interval|Geometric Mean
1372669|NCT01536405|Primary|Geometric Mean Titer (GMT) of VZV Antibodies|Sera were tested for VZV IgG antibody levels by gpELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results|||ELISA units/mL||95% Confidence Interval|Geometric Mean
1372670|NCT01536405|Primary|Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)|Sera were tested for rubella virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results|||Percentage of participants||95% Confidence Interval|Number
1372671|NCT01536405|Primary|Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL|Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results|||Percentage of participants||95% Confidence Interval|Number
1372672|NCT01536405|Primary|Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL|Sera were tested for measles virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results|||Percentage of participants||95% Confidence Interval|Number
1372673|NCT01536405|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL|Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results|||Percentage of participants||95% Confidence Interval|Number
1372674|NCT01536379|Secondary|Mean Prednisolone Use at Week 24|Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles).|Week 24|mITT Population|||mg/day||Standard Error|Least Squares Mean
1372675|NCT01536379|Secondary|Mean eGFR at Week 24 and Week 52|The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles).|Week 24 and Week 52|mITT Population|||mL/minute/1.73 square meter (m^2)||Standard Error|Least Squares Mean
1372676|NCT01536379|Secondary|Mean Serum Creatinine at Week 24 and Week 52|Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||micromole/L||Standard Error|Least Squares Mean
1372677|NCT01536379|Secondary|Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52|The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population. Participants analyzed had at least one biopsy.|||Proportion of participants|||Number
1372678|NCT01536379|Secondary|Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52|Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Ratio||Standard Error|Least Squares Mean
1372679|NCT01536379|Secondary|Regulatory T Cell (%CD4) at Week 24 and Week 52|Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of Regulatory T cell||Standard Error|Least Squares Mean
1372680|NCT01536379|Secondary|Regulatory T Cell Count at Week 24 and Week 52|Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
1372681|NCT01536379|Secondary|Activated T Cell Percentage at Week 24 and Week 52|Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of activated T cell||Standard Error|Least Squares Mean
1372682|NCT01536379|Secondary|Activated T Cell Count at Week 24 and Week 52|A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
1372683|NCT01536379|Secondary|Transitional B Cells Percentage at Week 24 and Week 52|Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of transitional B cells||Standard Error|Least Squares Mean
1372684|NCT01536379|Secondary|Transitional B Cells Count at Week 24 and Week 52|Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
1372685|NCT01536379|Secondary|Activated Memory B Cells Percentage at Week 24 and Week 52|Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of activated memory B cells||Standard Error|Least Squares Mean
1372686|NCT01536379|Secondary|Activated Memory B Cells Count at Week 24 and Week 52|Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
1372687|NCT01536379|Secondary|Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52|Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method.|Baseline, Week 24 and Week 52|mITT Population|||Percent change||Full Range|Median
1372688|NCT01536379|Primary|Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52|Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||G/L||Standard Deviation|Mean
1372736|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.|||milligram•hour/liter (mg•hr/L)||Standard Deviation|Mean
1372689|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52|Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||milliliter (mL)/Minute (min)||Standard Deviation|Mean
1372690|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52|Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Millimole (MMOL)/L||Standard Deviation|Mean
1372691|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52|Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Micromole per Liter (umol/L)||Standard Deviation|Mean
1372692|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52|Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||International Unit (IU)/L||Standard Deviation|Mean
1372693|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52|Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||G/L||Standard Deviation|Mean
1372694|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52|Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Tera (TI)/L||Standard Deviation|Mean
1372695|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52|Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Femtoliter (FL)||Standard Deviation|Mean
1372696|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52|Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Picogram (pg)||Standard Deviation|Mean
1372697|NCT01536379|Primary|Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52|Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Percentage of blood||Standard Deviation|Mean
1372698|NCT01536379|Primary|Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52|Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Grams per Liter (G/L)||Standard Deviation|Mean
1372699|NCT01536379|Primary|Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52|Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Gills/Liter (GI/L)||Standard Deviation|Mean
1372737|NCT01536145|Secondary|Single Dose End-of-infusion Concentration (Cinf) for CP-751,871||1 hour postdose in Cycle 1|All participants treated who had at least 1 concentration.|||milligram/liter (mg/L)||Standard Deviation|Mean
1372700|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52|Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Participants|||Number
1372701|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52|Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Participants|||Number
1372702|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52|Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Participants|||Number
1372703|NCT01536379|Primary|Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52|Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Degree Centigrade||Standard Deviation|Mean
1372704|NCT01536379|Primary|Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52|Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Beats per minute (BPM)||Standard Deviation|Mean
1372705|NCT01536379|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52|Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1372706|NCT01536379|Primary|Number of Incidence of All Infections and Serious Infections|All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection.|Up to 1 year|mITT Population|||Infections|||Number
1372707|NCT01536379|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)|Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths.|Up to 1 year|mITT Population|||Participants|||Number
1372708|NCT01536379|Primary|Change From Baseline in naïve B Cells From Baseline to Week 24|Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments.|Baseline and Week 24|Modified Intent to treat (MITT) Population|||cells/mm^3||Standard Error|Least Squares Mean
1372709|NCT01536366|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||ng.h/mL||Standard Deviation|Mean
1372710|NCT01536366|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||ng.h/mL||Standard Deviation|Mean
1372711|NCT01536366|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||hours||Full Range|Median
1372712|NCT01536366|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||ng/mL||Standard Deviation|Mean
1372713|NCT01536262|Secondary|Trough FEV1 Response|"Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.~Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose after 52 weeks|Full analysis set (FAS)|||L||Standard Error|Mean
1372714|NCT01536262|Secondary|FEV1 AUC0-3h Response|"Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.~Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks|Full analysis set (FAS): This patient set included all randomised patients who received at least 1 dose of treatment and had both non-missing baseline and at least 1 non-missing post-baseline efficacy measurement. Assignment to FAS was done after implementation of any data handling rules which set measurements to missing.|||L||Standard Error|Mean
1372715|NCT01536262|Primary|Number (%) of Patients With Drug-related AEs|Number (%) of patients with drug-related Adverse Events (AEs).|From first drug administration until 21 days after the last administration, upto 392 days|Treated set: This patient set included all patients who received at least 1 dose of treatment.|||percentage of participants|||Number
1372716|NCT01536197|Secondary|Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).|-Eating behavior will be measured with validated questionnaires including among others the Dutch Eating Behavior Questionnaire (DEBQ) and the Food Craving Inventory (FCI). The DEBQ measures three common psychological dimensions of eating behavior: 1) emotional eating , 2) external eating (an inclination to eat in response to external food cues such as the smell and taste of food), and 3) restrained eating (an inclination to consciously restrict food intake to control body weight). The FCI is a validated measure of the frequency of overall food cravings as well as cravings for specific types of foods (high fats, sweets, carbohydrates/ starches, and fast-food fats) during the past month. For the DEBQ and the FCI, subjects score their answers by using a 5-point Likert scale (1=never, 5=very often/always).Therefore, lower numbers means having less frequent food cravings (for FCI), or engaging less frequently in the particular type of eating behavior (for DEBQ).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery||||units on a scale||Standard Deviation|Mean
1372717|NCT01536197|Primary|Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).|-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery||||mmol/L||Inter-Quartile Range|Median
1372718|NCT01536184|Secondary|The Strengths and Difficulties Questionnaire SDQ|The Emotional Symptoms (SDQ-ES), Conduct Problems (SDQ-CP), Hyperactivity (SDQ-HA), Peer Problems (SDQ-PP), and Prosocial (SDQ-PS) Scales each range from 0-10 Higher values in (ES, CP, HA, and PP) indicate a greater degree of abnormal behavior; low values indicate more normative behavior. For the PS scale, higher values indicate greater strengths in prosocial behaviour and lower values indicate more difficulties with prosocial behavior. A Total Difficulties Score ranges from 0 to 40 with higher scores reflecting higher levels of behavioral difficulty. The Total Impact Supplement Score (Total IS) ranges from 0 to 10 with higher values indicating greater behavioral difficulty and social impairment.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Please see category specific n values below.|||units on a scale||Full Range|Mean
1372719|NCT01536184|Secondary|The Depression Anxiety Stress Scale (DASS)|"A self-report measure of depression, anxiety, and stress. The scales of the DASS show high internal consistency and produce meaningful discriminations in different settings, and are appropriate for measuring the emotional states of caregivers over time.~The score for each item ranges from 0 to 3, where 0 indicates did not apply to me at all and 3 indicates applied to me very much, or most of the time. The individual items are combined using a scoring template into measures of Depression (D), Anxiety (A), and Stress (S). Depression is scored out of 28 where 0-9 is normal and 10-28 reflect mild, moderate, and severe degrees of depression. Anxiety is scored out of 20 where 0-7 is normal and 8-20 reflect mild, moderate, and severe degrees of anxiety. Stress is scored out of 34 where 0-14 is normal and 15-34 reflect mild, moderate, and severe degrees of stress."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2|||units on a scale||Full Range|Mean
1372720|NCT01536184|Secondary|The Parenting Stress Index (PSI)|"A parent-report questionnaire of parental stress reflecting parent-child interaction style and difficult child behaviour. There are two main domain scores, a Child Domain Score and Parent Domain Score from which a Total Stress Score is calculated.~Child and Parent Domain raw scores combine to form a Total Stress raw score. Higher scores for each item indicate a higher degree of negative attributes in the given scale while lower scores indicate lower relationship stress and a greater sense of enjoyment in the relationship.~Items include:~Defensive Responding (DR) Score range 7-35 Parental Distress (PD) Score range 12-60 Parent-Child Dysfunctional Interaction (PCDI) Score range 12-60 Difficult Child (DC) Score range 12-60 PSI Total Stress Score range 36-180"|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)||||units on a scale||Full Range|Mean
1372738|NCT01536145|Primary|Maximum Tolerated Dose (MTD)|The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants|Baseline up to Cycle 1 (Week 4 or Week 8)|All participants who received at least 1 dose of study drug CP-751,871.|||mg/kg|||Number
1372739|NCT01536119|Secondary|Paternal Infant Feeding Attitude|Paternal infant feeding attitude will be assessed using the Iowa Infant Feeding Attitude Scale. This scale consist of 17 items with a five point response range (1-5). The total scores range from 17-85. Negative items were reverse scored. Lower scores indicate a preference for formula feeding, while higher scores indicating a preference for breastfeeding.|6 weeks postpartum|Analysis population included only fathers who completed the scale at 6 weeks postpartum|||units on a scale||Standard Deviation|Mean
1372721|NCT01536184|Secondary|The Parenting Scale (TPS)|"A self-report measure of dysfunctional parenting practices including laxness, over-reactivity, and verbosity. The scale has good internal consistency and test-restest reliability and scores are consistent with other measures of dysfunctional discipline and child misbehaviour.~Each subscale score, ranges from 1 to 7; for each subscale (Laxness, Overreactivity, Verbosity) lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours. The total score is calculated from a combination of each subscale and also ranges from 1 to 7, reflecting the degree of ineffective parenting behaviours across all categories with lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of Participants Analyzed Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2|||units on a scale||Full Range|Mean
1372722|NCT01536184|Primary|Attachment Classification|Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of participants analyzed Receives COS Intervention Pretest= 8; Post-test=3; Follow-up=4 Control Group Pretest=4; Post-test=1; Follow-up=1|||participants|||Number
1372723|NCT01536171|Primary|Metabolic Rate During Barefoot and Shod Running|"This study will measure the metabolic rate when a person runs on the treadmill with shoes (shod) and without shoes.~Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit||||kilojoules per minute||Standard Deviation|Mean
1372724|NCT01536171|Secondary|Peak Impact Forces During Barefoot and Shod Running|"This study will be measuring the peak impact forces that a runner produces when running on the treadmill with shoes (shod) and without shoes.~Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit||||Newtons||Standard Deviation|Mean
1372725|NCT01536145|Secondary|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease [PD])|Baseline up to end of treatment|A substantial number of participants were not followed-up prior to disease progression, therefore time to disease progression was not estimated.||||||
1372726|NCT01536145|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).|Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)|All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.|||percentage of participants|||Number
1372727|NCT01536145|Secondary|Human Anti-human Antibody (HAHA) Response to CP-751,871||30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg|All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.||||||Number
1372728|NCT01536145|Secondary|Pharmacodynamic-based Dose|The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression|Cycle 1 (Week 4 or Week 8)|Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.||||||
1372729|NCT01536145|Secondary|Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||0 hour (predose) in Cycles 2 up to 16|Multiple dose Cmin data were listed for individual subjects, however were not summarized by descriptive statistics.||||||
1372730|NCT01536145|Secondary|Multiple Dose Cinf for CP-751,871||1 hour postdose in Cycles 2 up to 16|Multiple dose Cinf data were listed for individual subjects, however were not summarized by descriptive statistics.||||||
1372731|NCT01536145|Secondary|Single Dose Systemic Clearance (CL) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
1372732|NCT01536145|Secondary|Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||mL/kg||Standard Deviation|Mean
1372733|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||mg•hr/L||Standard Deviation|Mean
1372734|NCT01536145|Secondary|Single Dose Plasma Decay Half-life (t1/2) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||days||Standard Deviation|Mean
1372735|NCT01536145|Secondary|Single Dose Volume of Distribution (Vz) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||milliliter/kilogram (mL/kg )||Standard Deviation|Mean
1372757|NCT01536093|Secondary|Time to Reach Full Feeding|day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day|up to 2 months of age|||||||
1372758|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||2 weeks of age|||||||
1372740|NCT01536119|Secondary|Paternal Breastfeeding Self-Efficacy|"Breastfeeding Self-Efficacy Scale- Short Form will be adapted and used to assess fathers' confidence with assisting their partner with breastfeeding.~This instrument has 14 items, with responses ranging from 1-5. The total scores range from 14-70 with higher scores indicating higher breastfeeding self-efficacy."|6 weeks postpartum|Analysis population included fathers completed the scale and who had infants breastfeeding at 6 weeks postpartum (fathers of infants fed expressed breastmilk were not included).|||units on a scale||Standard Deviation|Mean
1372741|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|12 weeks|Analysis population included only mothers who completed the scale at 12 weeks postpartum|||units on a scale||Standard Deviation|Mean
1372742|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|6 weeks|Analysis population included only mothers who completed the scale at 6 weeks postpartum.|||units on a scale||Standard Deviation|Mean
1372743|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS). There are 35 items in total in this tool. There is a 7 point response scale ranging from 0 to 6. Total scores range from 0 - 210. Negative items are reversed. Higher scores indicated positive coparenting.|12 weeks postpartum|Analysis population included only mothers who completed the scale at 12 weeks postpartum.|||units on a scale||Standard Deviation|Mean
1372744|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS) Brief Form. There are 14 items in total in this tool. There is a 7 point response scale ranging from 0 - 6. The total score ranges from 0 - 84. Negative items are reversed and the higher scores indicate positive coparenting.|6 weeks|Analysis population included only mothers who completed the questionnaire at 6 weeks postpartum.|||units on a scale||Standard Deviation|Mean
1372745|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|12 weeks|Analysis population included only mothers|||participants|||Number
1372746|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|6 weeks|Analysis population included only mothers|||participants|||Number
1372747|NCT01536119|Secondary|Exclusive Breastfeeding|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|6 weeks|Analysis population included only mothers|||percentage of participants|||Number
1372748|NCT01536119|Primary|Exclusive Breastfeeding Rate at 12 Weeks Postpartum|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|12 weeks postpartum|Analysis population included only mothers|||percentage of participants|||Number
1372749|NCT01536093|Secondary|Development of Adverse Effects|"category of adverse effects~general - fever or hypothermia, rash~respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia~gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis~renal - oliguria (urine output < 1.0cc/kg/day)~laboratory - hypo-/hyper-natremia, acidosis, hypercarbia"|from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age|||||||
1372750|NCT01536093|Secondary|In-hospital Death||up to 4 months of age|||||||
1372751|NCT01536093|Secondary|Development of Intraventricular Hemorrhage ≥ Grade 3||up to 4 months of age|||||||
1372752|NCT01536093|Secondary|Development of Bronchopulmonary Dysplasia ≥ Moderate||up to 4 months of age|||||||
1372753|NCT01536093|Secondary|Episodes of Pneumonia|numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics|from date of randomization up to 4 months of age|||||||
1372754|NCT01536093|Secondary|Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2||from date of randomization up to 4 months of age|||||||
1372755|NCT01536093|Secondary|Episodes of Culture Positive Sepsis|numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)|from date of randomization up to 4 months of age|||||||
1372756|NCT01536093|Secondary|Total Hospital Admission Duration|days from admission to discharge from NICU|up to 4 months of age|||||||
1372774|NCT01536067|Primary|Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib|Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.|Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1372775|NCT01536015|Secondary|Change in Score on Parkinson’s Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period|The Parkinson’s Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
1372776|NCT01536015|Secondary|Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period|"The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree)."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
1372777|NCT01536015|Secondary|Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period|Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
1372778|NCT01536015|Secondary|"Change in Predictability of Off Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
1372779|NCT01536015|Secondary|"Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the on State From Baseline to the End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
1372780|NCT01536015|Primary|"Change in Rotigotine Versus Placebo in the Absolute Time Spent Off From Baseline to the End of the 7-week Maintenance Period"|"Mean number of hours marked off during a 24-hour period."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
1372781|NCT01535976|Primary|Intraoperative Hypoventilation|Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.|8 hours|The median percentage of the sedation time with TCO2 > 50 mmHg|||% time||95% Confidence Interval|Median
1372782|NCT01535807|Secondary|Post Operative Atrial Fibrillation|Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.|Within 30 days|||||||
1372783|NCT01535807|Primary|Inflammatory Biomarkers|"The identification of global low molecular weight (LMW) serum proteomic changes associated with CorMatrix ECM treated patients.~Identification of porcine specific LMW and phosphoproteomic serum protein changes associated with CorMatrix ECM treated patients."|Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3.||||participants|||Number
1372784|NCT01535729|Secondary|Median Overall Survival: Best Response to Prior Chemotherapy|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the CRF, hence, the analysis could not be performed.||||||
1372785|NCT01535729|Secondary|Median Overall Survival: Smoking Status|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1372786|NCT01535729|Secondary|Median Overall Survival: Gender|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1372787|NCT01535729|Secondary|Median Overall Survival: Overall|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1373140|NCT01531374|Secondary|Cardiovascular Deaths and Valve-Related Deaths||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1372788|NCT01535729|Secondary|Median Progression Free Survival: Best Response to Prior Chemotherapy|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the Case Report Form (CRF), hence, the analysis could not be performed.||||||
1372789|NCT01535729|Secondary|Median Progression Free Survival: Smoking Status|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1372790|NCT01535729|Secondary|Median Progression Free Survival: Gender|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1372791|NCT01535729|Secondary|Median Progression Free Survival: Age|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1372792|NCT01535729|Secondary|Median Progression Free Survival: Overall|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression no death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1372793|NCT01535729|Secondary|Percentage of Participants With Remission of CR and PR|Remission was defined as participants with CR or PR. CR: disappearance of all TLs and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372794|NCT01535729|Secondary|Time to Start of Erlotinib Therapy After End of First Line Therapy||Baseline|SAF with number of participants evaluable for this outcome measure.|||months||Full Range|Median
1372795|NCT01535729|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)|Response rate was observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST). It consisted of CR, PR, SD and progressive disease (PD). Participants with CR, PR and SD were reported. CR: disappearance of all target lesions (TLs) and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372796|NCT01535729|Secondary|Percentage of Participants With Dyspnea by Severity|Severity of dyspnea was categorized as mild, moderate, severe, life-threatening and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no dyspnea were not included.|Baseline, Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372797|NCT01535729|Secondary|Percentage of Participants With Cough by Severity|Severity of cough was categorized as mild, moderate, severe and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no cough were not included.|Baseline, Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372798|NCT01535729|Secondary|Percentage of Participants With Dose Withdrawals by Reason|Reasons for dose withdrawals included progression, participants' wish, intolerance, others and not known. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1373141|NCT01531374|Secondary|Aortic Valve Hospitalizations||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1372799|NCT01535729|Secondary|Percentage of Participants With Dose Modifications by Reason|Dose modification included increase or decreased in the dose of the drug and interrupted dose. Reasons for dose modification included progression, participants' wish, intolerance and others. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372800|NCT01535729|Secondary|Percentage of Participants With Fatigue Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372801|NCT01535729|Secondary|Percentage of Participants With Diarrhea Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372802|NCT01535729|Secondary|Percentage of Participants With Rash Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372803|NCT01535729|Secondary|Percentage of Participants With Diarrhea||Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372804|NCT01535729|Secondary|Percentage of Participants With Rash||Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372805|NCT01535729|Secondary|Percentage of Participants With Fatigue||Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
1372806|NCT01535729|Secondary|Median Overall Survival: Age|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
1372807|NCT01535729|Primary|Percentage of Participants Who Were Alive 1 Year After Start of Treatment|Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.|Year 1|SAF|||percentage of participants||95% Confidence Interval|Number
1372808|NCT01535664|Primary|Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).~Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT*0.5) + (ZADT*0.2) + (ZLOS*0.3)~Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)|||units on a scale||Standard Deviation|Mean
1372809|NCT01535664|Secondary|Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS population~A higher walking speed is indicative of better performance"|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population|||Feet per second (ft/s)||Standard Deviation|Mean
1372810|NCT01535664|Secondary|Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch.~A larger walking distance is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population|||Meters||Standard Deviation|Mean
1372811|NCT01535664|Secondary|Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|The BBS is a 14-item scale that evaluates subjects ability to sit, stand, reach, maintain single-leg stance, and turn. The scoring is rated from 0 (cannot perform task) to 4 (normal performance of task) for each of 14 items. The maximum possible score is 56 and the lowest 0. A higher total score is indicative of better performance.|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population|||units on a scale||Standard Deviation|Mean
1375078|NCT01509040|Secondary|Enrollment|This will be defined as the proportion of eligible patients who are randomized.|12 hours||||participants|||Number
1372812|NCT01535664|Primary|Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).~ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway).~Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)|||units on a scale||Standard Deviation|Mean
1372813|NCT01535638|Primary|Cmax|Maximum measured concentration of Deleobuvir in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|1:00 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1372814|NCT01535638|Primary|AUC0-∞|"Area under the concentration-time curve of Deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS) included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK and no vomiting must have occurred at or before two times the median tmax.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1372815|NCT01535599|Secondary|Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary|Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.|Time to event, up to Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. Patients who did not report ear pain at any diary entry during first 7 days of the study were excluded from the analysis.|||days||Standard Error|Median
1372816|NCT01535599|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.|||percentage of participants|||Number
1372817|NCT01535599|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.|||percentage of participants|||Number
1372818|NCT01535560|Secondary|Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary|Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.|Time to event (Day 1 to Day 11)|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline, minus missing responses.|||Days||Standard Error|Median
1372819|NCT01535560|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.|||Percentage of participants|||Number
1372820|NCT01535560|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.|||Percentage of participants|||Number
1372821|NCT01535365|Secondary|Request for Rescue Analgesia|Number of participants requesting a rescue analgesic be given|30 minutes||||Participants|||Number
1372822|NCT01535365|Primary|Pain Score After Treatment|Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable|30 minutes|this sample size gives 80% power to detect a size effect of one SD|||mm||95% Confidence Interval|Mean
1372823|NCT01535326|Other Pre-specified|Post-procedure Discomforts and 30 Day Complication Rate|telephone follow up for post-procedure discomforts and 30 day complication rate|one month|||||||
1372824|NCT01535326|Secondary|Number of Participants With at Least One Adenoma|the number of participants with at least one adenoma in each of the study groups.|9 to 12 months||||participants|||Number
1372828|NCT01535287|Secondary|Muscle Pain|"Postoperative muscle pain or swelling at the drug injection site. The duration of the stay in the PACU will be retrospectively documented by the research team using EPIC. Data regarding postoperative muscle pain or swelling will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by yes/no by staff based on parent(s) response."|Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events|||Number
1372829|NCT01535287|Secondary|Post-Operative Behavioral Disturbances|"Behavioral disturbances analyzed are: sleep disturbances, anxiety, eating disturbances. These post-operative behavioral disturbances are not considered an adverse event. Data regarding postoperative behavioral disturbances will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any other adverse event (not including serious) will also be documented by the telephone interview. Measurement will be obtained by yes/no to each possible AE by staff based on parent(s) response. Other adverse events (not including serious) reported immediately post-operatively includes: 1. allergic reaction to medication, 2. Respiratory distress, 3. Bronchospasms 4. Laryngospasm, 5. Hemodynamic instability"|Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events|||Number
1372830|NCT01535287|Secondary|Hemodynamic Instability|"Postoperative adverse hemodynamic events: bradycardia-a decrease in heart rate, hypotension-a decrease in systolic blood pressure (both determined as a 30% decrease from baseline) during PACU duration to discharge. The adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered.Measurement will be obtained by yes/no to each possible adverse respiratory event by anesthesia staff."|Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events||Standard Deviation|Mean
1372831|NCT01535287|Secondary|Respiratory Complications Peri-Operative|"Postoperative adverse respiratory events: moderate to severe coughing, oxygen desaturation (SPO2 <90%), breath holding, bronchospasm, aspiration, stridor and/or laryngospasm during PACU duration to discharge. The adverse respiratory events and the adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered. Measurement will be obtained by yes/no to each possible adverse respiratory event by anesthesia staff."|Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events||Standard Error|Mean
1372832|NCT01535287|Secondary|Duration of Stay in PACU|Duration of stay in the PACU (Post-Op Area) until discharge criteria are met based on modified PADSS score: level of consciousness, physical activity, hemodynamic stability, respiratory stability, oxygen saturation status, post-operative pain, and post-operative emetic symptoms. Duration of time will be measured in total minutes participate is in PACU until discharged.|Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.||||minutes||Standard Deviation|Mean
1372833|NCT01535287|Primary|Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area).|"The aim/measurement of the study is to determine whether or not a single IM injection of Dexmedetomidine will reduce the severity of Emergent Agitation (EA) in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia.~We used the only validated scale to assess the severity of post operative emergence delirium in pediatrics. This Pediatric Anesthesia Emergence Delirium (PAED) scale is a composite score of the following items:~Makes eye contact with caregiver.~Child's actions are purposeful.~Child aware of his/her surroundings.~The child is restless.~The child is inconsolable.~Items 1, 2, and 3 are reversed scored as follows: 4-not at all, 3-a little, 2-quite a bit, 1-very much, 0-extremely. Items 4 and 5 are scored as follows: 0-not at all, 1-a little, 2-quite a bit, 3-very much, 4-extremely.~The total score will range from 0 to 20; with 0 indicating no emergence delirium and 20 indicating extreme emergence delirium."|Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.||||units on a scale||Standard Deviation|Mean
1372834|NCT01535261|Secondary|Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value for both baseline and the post-baseline visit.|||Score on a scale||Standard Deviation|Mean
1372835|NCT01535261|Secondary|Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.|||Microns||Standard Deviation|Mean
1385423|NCT01402128|Primary|Changes in Percent Body Fat(%)|Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||percentage of body fat||Standard Deviation|Mean
1372836|NCT01535261|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.|||Letters|||Number
1372837|NCT01535261|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at month 12 as compared with baseline|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.|||Letters|||Number
1372838|NCT01535261|Secondary|Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy|Month 12 and Month 24|Full analysis set with use of LOCF consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value at treatment interruption and an average for the post treatment interruption visits.|||Letters||Standard Deviation|Mean
1372839|NCT01535261|Secondary|Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients.|Baseline and Month 1 to 12 or Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.|||letters||Standard Deviation|Mean
1372840|NCT01535261|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.|||Letters||Standard Deviation|Mean
1372841|NCT01535261|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.|||Letters||Standard Deviation|Mean
1372842|NCT01535235|Secondary|Change in HIV DNA (Copies/Million Rectal Cells)|Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.|||copies/million rectal cells||Inter-Quartile Range|Median
1372843|NCT01535235|Primary|Change in HIV RNA (Copies/Million Rectal Cells)|Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.|||copies/million rectal cells||Inter-Quartile Range|Median
1372844|NCT01535222|Primary|Incidence of Serious Adverse Events|Number of patients experiencing Serious Adverse Events|7 days (day of surgery to day 7)||||participants|||Number
1372845|NCT01535222|Primary|Incidence of Adverse Events|Number of patients experiencing Adverse Events|7 days (day of surgery to day 7)||||participants|||Number
1372846|NCT01535118|Secondary|Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma|Participants were asked about co-morbid health conditions. The percentage of participants who had received allergy shots to treat ARC and had asthma was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey and received allergy shots.|||percentage of participants|||Number
1372847|NCT01535118|Primary|Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication|Participants who received subcutaneous immunotherapy (allergy shots) were asked about prescription and over-the-counter medication use. The percentage of participants who received allergy shots to treat ARC, had not taken over-the-counter allergy medication and required supplemental prescription allergy medication for ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey, received immunotherapy (allergy shots) and had not taken over-the-counter allergy medication.|||percentage of participants|||Number
1372848|NCT01535118|Primary|Percentage of Participants Who Received Immunotherapy to Treat ARC|Participants who had ever received immunotherapy for ARC were asked about the type of immunotherapy - subcutaneous or sublingual - received. The percentage of participants who received immunotherapy to treat ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
1372849|NCT01535118|Primary|Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months|Participants were asked about prescription and over-the-counter medication use for ARC. The percentages of participants who used prescription and/or over-the-counter medication to treat ARC in the past 12 months were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
1372850|NCT01535118|Primary|Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months|Participants were asked about the impact of ARC on loss of work and school time. The percentage of participants who experienced work or school absence due to ARC in the prior 12 months was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
1372851|NCT01535118|Primary|Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)|Participants were asked about the frequency and severity of ARC symptoms when allergies were at their worst. The percentages of participants who experienced different symptoms of ARC on a daily basis when allergies were at their worst were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
1372852|NCT01535040|Secondary|Smoking Withdrawal|The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).|12 weeks|Participants who provided data at any time|||units on a scale||Standard Error|Least Squares Mean
1372853|NCT01535040|Secondary|Nicotine Dependence|The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.|12 weeks|Participants who reported any data|||units on a scale||Standard Error|Least Squares Mean
1372854|NCT01535040|Primary|Adherence|Adherence is the percentage of prescribed pills taken while on therapy.|12 weeks|Participants who returned pill diaries.|||percentage of prescribed pills||Full Range|Mean
1372855|NCT01535040|Primary|Retention|Retention is defined as the percentage of participants who complete the 12 week visit|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1372856|NCT01535001|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.~Number of sites with pain in the previous 24 hours shaded on a region-divided body chart~Pain location and type assessed using the Knee Pain Map.~Maximum isometric muscle strength measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander).~Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II) at five sites at the knee and the m. tibialis anterior muscle and the m. extensor carpi radialis longus.~Postural balance assessed using an instrumented force platform (Good Balance), measuring the centre of pressure excursion.~Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'."|Baseline, 3months, 6months, 12months and 24months|Since this is exploratory outcomes they will be analyzed in future publications.||||||
1372857|NCT01535001|Secondary|Change From Baseline in Time From the Timed Up and Go||Primary: 12 months.||||sec||95% Confidence Interval|Mean
1372858|NCT01535001|Secondary|Number of Serious Adverse Events Reported at Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants.|Primary: 12months.||||Serious adverse events related to knee|||Number
1372859|NCT01535001|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.||||proportion of participants||95% Confidence Interval|Number
1372860|NCT01535001|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in this analysis.|||kg||95% Confidence Interval|Mean
1372861|NCT01535001|Secondary|Change in the Five KOOS Subscale Scores From Baseline|Range of all subscales are 0 to 100 (worst to best).|Primary: 12 months.||||units on a scale||95% Confidence Interval|Number
1372862|NCT01535001|Secondary|Change From Baseline in 20-meter Walk||Primary: 12months.||||sec||95% Confidence Interval|Mean
1372863|NCT01535001|Secondary|Change From Baseline in EQ-5D|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See statistical analysis plan for further description (available under Links).~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
1372880|NCT01534689|Secondary|Change in Millimeter (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.|12 weeks||||millilmeters||Standard Deviation|Mean
1372864|NCT01535001|Primary|Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)|"The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best).~Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority."|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
1372865|NCT01534975|Primary|Image Quality of the CT Scans Using Different Contrast Agents|Attenuation (HU) in the ascending aorta, standard deviation (SD) of aorta, will be measured,.|1 year||||hounsfield units||Standard Deviation|Mean
1372866|NCT01534962|Secondary|Number of Patients in Sinus Rhythm 48 Hours After Cardioversion With Documented AF Recurrence|Documented AF recurrences in those patients who did not experience early relapses (within 48 hours after cardioversion)|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion|||participants|||Number
1372867|NCT01534962|Secondary|Time From Randomization to First Documented AF Recurrence in Patients With Sinus Rhythm 48 Hours After Cardioversion|Excluding patients with early relapses (within 48 hours) while the study drug, started after cardioversion, had not yet reached steady-state.|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion|||Days||95% Confidence Interval|Median
1372868|NCT01534962|Secondary|Number of Patients With Documented and Confirmed AF Recurrences||16 weeks (112 days)|Intention-to-Treat|||participants|||Number
1372869|NCT01534962|Secondary|Time From Randomization to First Documented and Confirmed AF Recurrence|A confirmed AF recurrence was defined as a documented AF recurrence which was confirmed by a consecutive ECG performed at least 1 hour after first AF documentation.|16 weeks (112 days)|Intention-to-Treat (N=238)|||Days||95% Confidence Interval|Median
1372870|NCT01534962|Secondary|Number of Patients With Documented AF Recurrences||16 weeks (112 days)|Intention-to-Treat (N=238)|||participants|||Number
1372871|NCT01534962|Primary|Time From Randomization to First Documented AF Recurrence.|"Time to first AF recurrence reported by patient-reported TT-ECG or 12-Lead ECG at the study site, whichever occurred first.~Patients discontinuing the study without AF were censored at the time of the last available ECG."|16 weeks (112 days)|Intention-to-treat-approach that analyzed all randomised patients who took at least one dose of study medication (N=238, i.e. excluding 3 randomized patients).|||Days||95% Confidence Interval|Median
1372872|NCT01534910|Secondary|Coronary Calcium|Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: >400|1 year|patients undergoing two calcium scores|||agatston units||95% Confidence Interval|Mean
1372873|NCT01534910|Primary|CT Angiography Plaque|"we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as [followup-baseline]/baseline x100%.~Baseline was time zero, followup CT scan was 1 year."|baseline to 1 year||||percent change of low attenuation plaque||Standard Deviation|Mean
1372874|NCT01534897|Secondary|Clinical Benefit as Measured by Change in Thyroglobulin Level|To evaluate clinical benefit as measured by change in serum tumor marker, thyroglobulin. Rising thyroglobulin is generally indicative of tumor growth.|3 months after radioiodine therapy||||Participants|||Count of Participants
1372875|NCT01534897|Secondary|Number of Participants Who Complete the Study With Minimal Delays and no Dose Reductions|To determine the feasibility of: (a) administering GSK2118436 for 28 days in patients with BRAF V600E-mutant PTC, prior to whole body iodine scanning (all patients); and (b) administering GSK2118436 for an additional 14 days, prior to administering treatment doses of radioactive iodine (patients whose tumors demonstrate significant iodine uptake after 28 days of treatment).|2 years||||Participants|||Count of Participants
1372876|NCT01534897|Secondary|Clinical Benefit as Measured by Change in Tumor Size|To evaluate clinical benefit as measured by objective response rate per modified RECIST 1.1, which assesses changes in size of measurable tumors. (per RECIST, a partial response (PR) = at least 30% decrease in size of tumor; progressive disease (PD) = at least 20% increase in size of tumor; stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).|2 years||||Participants|||Count of Participants
1372877|NCT01534897|Secondary|Safety Analysis as Number of Participants With Adverse Events|To evaluate the safety and tolerability, as determined by adverse event and serious adverse event reporting, of GSK2118436 in combination with whole body iodine scans (all patients) and treatment doses of radioactive iodine (patients whose tumors demonstrate significant iodine uptake).|2 years|All patients completed dabrafenib without dose modification.|||Participants|||Count of Participants
1372878|NCT01534897|Primary|Increased Radioiodine Uptake|Number of patients with radioiodine-refractory metastatic BRAF V600E-mutant PTC who have increased radioiodine uptake in their disease sites while on dabrafenib. Radioiodine uptake is assessed by whole body scan and areas of interest are identified by nuclear medicine physicians.|25 days after start of Dabrafenib (GSK2118436)||||Participants|||Count of Participants
1372879|NCT01534689|Secondary|Change in Percent (%) of mm Clear Nail|Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.|12 weeks||||percentage of change in mm clear nail||Standard Deviation|Mean
1373156|NCT01531205|Secondary|Incidence of Detecting Circulating Tumor Cells (CTC)|To determine the feasibility of detecting circulating tumor cells in this patient population. CTC results per patient in milliliters.|One Year|All participants|||CTC/mL|||Number
1372881|NCT01534689|Primary|Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail|"Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success.~Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria."|12 weeks||||percentage of toenails|||Number
1372882|NCT01534676|Primary|Non-transferrin-bound Iron Level||2 hours after transfusion|Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed.||||||
1372883|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs||Week 5||||participants|||Number
1372884|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs||Week 1||||participants|||Number
1372885|NCT01534637|Primary|Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation|Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.|Over 10 weeks||||participants|||Number
1372886|NCT01534533|Secondary|Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods|Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||3333-12-31|12/3333||||
1372887|NCT01534533|Secondary|Dietary Intake of Energy During the Study Periods|Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||3333-12-31|12/3333||||
1372888|NCT01534533|Secondary|Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months|Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).|at baseline and after 12 months||3333-12-31|12/3333||||
1372889|NCT01534533|Primary|Table 1 Study Specific Characteristic of Serum Carotenoids|serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||μg/ml||Standard Deviation|Mean
1372890|NCT01534533|Primary|Table 1 Study Specific Characteristic of Blood Pressure (BP)|systolic BP and diastolic BP in four groups was measure twice between 15minutes|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||mm Hg||Standard Deviation|Mean
1372891|NCT01534533|Primary|Table 1 Study Specific Characteristic of Body Mass Index (BMI)|the mean and standard deviation of BMI in four groups was calculated|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||Kg/m^2||Standard Deviation|Mean
1372892|NCT01534533|Primary|Table 1 Study Specific Characteristic of Age|the mean and standard deviation of age was calculated in four groups|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||years||Standard Deviation|Mean
1372893|NCT01534533|Primary|Table 1 Study Specific Characteristic Part One|The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||Percentage of Participants|||Number
1372894|NCT01534520|Secondary|Need for Pain Medication up to 7 Days|Number of women taking pain medication for at least one day following IUD insertion|7 days post-insertion||||participants|||Number
1372895|NCT01534520|Secondary|Percentage of IUDs Considered by Physicians Easy to Insert|"The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be easy was calculated for each study group."|Directly after IUD insertion|Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later.|||percentage of insertions declared easy||95% Confidence Interval|Number
1372896|NCT01534520|Secondary|To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD|"Number of participants who rated self-application of study gel as some what easy or very easy on Likert scale"|After inserting the gel but prior to IUD insertion||||participants who found gel easy to use|||Number
1372897|NCT01534520|Primary|Change in Pain From Baseline to IUD Insertion|To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient’s life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).|change in pain score from baseline (before IUD insertion) to time of IUD insertion||||change in visual analog scale score||Inter-Quartile Range|Median
1372898|NCT01534416|Secondary|Postoperative Day Pain Medication Use|Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.|Postoperative days 0-10|missing data from 5 participants in Bupivacaine Arm and 4 in Saline Arm|||participants|||Number
1372934|NCT01534078|Secondary|Grade III or IV Adverse Events|A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.|2 years||||participants|||Number
1372899|NCT01534416|Secondary|Postoperative Pain Score|Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level.|1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative|Only those subjects with pain analyzed|||units on a scale||Standard Deviation|Mean
1372900|NCT01534416|Secondary|Postoperative Pain Score|Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.|1and 2 hour postoperatively|This doesn't include hospitalization for reasons other than pain management.|||units on a scale||Standard Deviation|Mean
1372901|NCT01534416|Primary|Number of Participants With Hospital Admission for Postoperative Pain Control|Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management|Four hours after conclusion of surgery||||Participants|||Count of Participants
1372902|NCT01534351|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 52 weeks|All Participants as Treated (APaT) - population consists of all randomized participants who received at least one dose of study treatment. As only one participant was randomized in the study, no analyses were performed.|||Participants|||Number
1372903|NCT01534351|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 54 weeks||||Participants|||Number
1372904|NCT01534351|Primary|Percent Change From Baseline in Prostate Volume|Prostate volume was assessed by trans-rectal ultrasound (TRUS).|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.||||||
1372905|NCT01534351|Primary|Change From Baseline in International Prostate Symptom Score (IPSS)|The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.||||||
1372906|NCT01534260|Secondary|Phase II – Treatment-Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.|Up to one year|All Phase II patients who received treatment.|||Participants|||Count of Participants
1372907|NCT01534260|Secondary|Phase II – Time to Relapse|Will be examined using Kaplan-Meier estimates. Time from date of confirmed complete remission to date of relapse. The observations of patients who died or remained alive and relapse free were censored at date of death or last disease evaluation, respectively.|Up to one year|All Phase II patients who received at least one dose of study drug, had at least one evaluable post-baseline visit, and achieved complete remission|||days||95% Confidence Interval|Median
1372908|NCT01534260|Primary|Phase II – Percentage of Patients With a Partial Response or Greater|Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for AML.|up to 9 months|All Phase II patients who received at least one dose of study drug and had at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
1372909|NCT01534260|Primary|Number of Patients With Dose Limiting Toxicity|The number of patients who had a DLT during the dose finding/confirming portion (Phase I) of the trial for the safety of the combination of sorafenib, vorinostat, and bortezomib.|up to 9 months|All Phase I patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||Participants|||Count of Participants
1372910|NCT01534208|Primary|Change From Baseline in FSH|Change from baseline in FSH at end of treatment (26 weeks)|6 months||||U/L||Standard Deviation|Mean
1372911|NCT01534208|Primary|Change From Baseline in BMI|Mean change from baseline in BMI at end of treatment (26 weeks)|6 months|ITT|||kg/m2||Standard Deviation|Mean
1372912|NCT01534208|Primary|Mean Change From Baseline FPG|Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)|6 months||||mg/dL||Standard Deviation|Mean
1372913|NCT01534208|Primary|Absolute Values of Morning Testosterone|Absolute values of morning testosterone at end of treatment (26 weeks)|6 months|ITT|||ng/dL||Standard Deviation|Mean
1372914|NCT01534208|Primary|Change From Baseline in LH|Mean change from baseline in LH at end of treatment (26 weeks)|6 months|ITT|||mIu/mL||Standard Deviation|Mean
1372915|NCT01534208|Primary|Change From Baseline in Total Morning Testosterone at 26 Weeks|Changes in values from baseline of total morning testosterone levels at Week 26|6 months|Intent to Treat population|||ng/dL||Standard Deviation|Mean
1375079|NCT01509040|Primary|Intervention Compliance|Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.|48 hours||||participants|||Number
1372916|NCT01534182|Secondary|Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)|The SF-36 is a health-related quality of life instrument used in numerous disease states, including MS (Brazier et al 1992). It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each domain was scored by adding the individual items from the domain and transforming the resulting scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, 6 months|Participants from the full analysis set were considered for this analysis. However, for a given time frame, participants analyzed had both baseline and 6 month asssessment values.|||scores on scale||Standard Deviation|Mean
1372917|NCT01534182|Secondary|Change in Patient-reported Depression|The Beck Depression Inventory (BDI-I) scale was used to measure this outcome. The scale consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each item was scored from 0 - 3. If more than one score was provided for an item, the maximum score was considered the item score. The total score was calculated as the sum of all individual items and then compared to a key to determine the depression's severity. The standard key ranges were: 0 - 9 indicated minimal depression; 10 - 18 indicated mild depression; 19 - 29 indicated moderate depression and 30 - 63 indicated severe depression. Higher total scores indicate more severe depressive symptoms.|Baseline, 6 months|FAS: The LOCF method was applied.|||scores on a scale||Standard Deviation|Mean
1372918|NCT01534182|Secondary|Changes in Patient-reported Effectiveness, Side Effects and Convenience|TSQM v 1.4 domains for effectiveness, side effects and convenience were used to evaluate this outcome. The effectiveness domain for items 1 - 3 was scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the side effects domain, item 4 scored as 0(no) or 1(yes); item 5 scored as 1 (extremely bothersome) to 5 (not at all bothersome); and items 6 - 8 scored as 1 (a great deal) to 5 (not at all). For the convenience domain, items 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and item 11 scored as 1 (extremely inconvenient) to 7 (extremely convenient). For each domain, scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|FAS: The LOCF method was applied.|||scores on a scale||Standard Deviation|Mean
1372919|NCT01534182|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|6 months|Safety Set: This set included all randomized participants who received at least one dose of study medication.|||Participants|||Number
1372920|NCT01534182|Primary|Change in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|Full Analysis Set (FAS): This set included all randomized participants who had taken at least one dose of study medication and had at least one post-baseline assessment of the TSQM. The last observation carried forward (LOCF) method was applied.|||scores on a scale||Standard Deviation|Mean
1372921|NCT01534143|Secondary|Recovery of T-cell, B Cell and NK Cell Phenotypes||Days 30, 60, 90, and at 6 months after transplant|||||||
1372922|NCT01534143|Secondary|Progression Free Survival||From the day of transplant to progression, death, or last contact, assessed up to 2 years|||||||
1372923|NCT01534143|Secondary|Overall Survival||Up to 2 years post transplant|||||||
1372924|NCT01534143|Secondary|Incidence of Opportunistic Infections Including CMV, HSV, and EBV Reactivation||Weekly to day 100|||||||
1372925|NCT01534143|Secondary|Incidence and Severity of Chronic GVHD||Up to 2 years post transplant|||||||
1372926|NCT01534143|Secondary|Incidence of SOS||Up to 2 years post transplant|||||||
1372927|NCT01534143|Secondary|Incidence of TTP||Up to 2 years post transplant|||||||
1372928|NCT01534143|Secondary|Incidence of Transplant Related Mortality and Morbidity||Up to 2 years post transplant|||||||
1372929|NCT01534143|Secondary|Incidence of Myeloma Progression||Time to the first observation of disease progression/relapse post transplant, assessed up to 2 years post transplant|||||||
1372930|NCT01534143|Primary|Grade III and IV Non Hematologic Toxicities|Based on NCI CTCAE version 4.|First 6 months post transplant|||||||
1372931|NCT01534143|Primary|Treatment Related Mortality Defined as Death in Continuous or Complete Remission|Based on National Cancer Institute (NCI) CTCAE version 4.|From the date of transplant to the date of death, assessed up to 6 months post transplant|||||||
1372932|NCT01534143|Primary|Time to Platelet Absolute Neutrophil Recovery (Engraftment)|Estimated using Kaplan-Meier method.|First 6 months post-transplant|||||||
1372933|NCT01534143|Primary|Incidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin|Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.|First 6 months post-transplant|Data was not collected, because funding was unavailable to continue study.||||||
1375388|NCT01505764|Secondary|Functional Performance.|Functional performance using stair-climbing power day 84 percent change from baseline|day 84|only two subjects in each group completed this measure.|||percentage change||Standard Deviation|Mean
1372935|NCT01534078|Secondary|Overall Response Rate|"The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.~CR: Disappearance of all evidence of disease~PR: Regression of measurable disease and no new sites"|End of Therapy (median duration of four months)|Two participants were not evaluated for response due to a death and a withdrawal.|||Participants|||Count of Participants
1372936|NCT01534078|Secondary|Overall Response Rate After One Cycle of Brentuximab|"The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.~CR: Disappearance of all evidence of disease~PR: Regression of measurable disease and no new sites"|28 days||||Participants|||Count of Participants
1372937|NCT01534078|Primary|Complete Response Rate|Complete response rate at the end of therapy as measured by Positron emission tomography–computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.|End of Therapy (median duration of four months)|Two participants were not evaluated for response due to a death and a withdrawal.|||Participants|||Count of Participants
1372938|NCT01534052|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.|From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days|The analysis population was the SAF.|||Participants|||Count of Participants
1372939|NCT01533974|Primary|Number of Participants Who Stopped Smoking by 12 Month Post Treatment|30 day point prevalence abstinence at 12 months. Missing = smoking and self report.|12 months||||participants|||Number
1372940|NCT01533948|Secondary|The Baseline Circulative Tumor Cells Value of Responders|The baseline Circulative tumor Cells values of patients with response to treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. CTC were evaluated at baseline, response was assessed up to 30 days.|Baseline|All treated and eligible patients that responded|||cells/mm^3||Standard Deviation|Mean
1372941|NCT01533948|Secondary|Median Overall Survival (OS)|The distribution will be described using Kaplan-Meier and proportional hazards methods.|From the date of study enrollment to the time of death within 30 days after last dose of study drug|All treated and eligible patients|||months||95% Confidence Interval|Median
1372942|NCT01533948|Secondary|Median Progression-free Survival (PFS)|The distribution will be described using Kaplan-Meier and proportional hazards methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From the date of study enrollment to the first observation of progressive disease or death within 30 days after last dose of study drug|All treated and eligible patients|||months||95% Confidence Interval|Median
1372943|NCT01533948|Secondary|Number of Patients That Experienced at Least One Grade 3 Adverse Event|Number of patients that experienced at least one grade 3 toxicity regardless of attribution. Incidence of toxicity of axitinib as a single agent as assessed by the severity of adverse effects by NCI CTCAE version 4. Please refer to the adverse event reporting for more detail.|Up to 30 days|All treated and eligible patients|||Participants|||Count of Participants
1372944|NCT01533948|Primary|Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 30 days|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1372945|NCT01533935|Secondary|FEV1 (1 Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose).~The presented means are adjusted means from MMRM model."|6 weeks|All patients in FAS with available FEV1 data at baseline and week 6 are included in the analysis.|||Litres||Standard Error|Mean
1372946|NCT01533935|Secondary|Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).~Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.~A decrease in slope indicates improvement.~The presented means are adjusted means from MMRM model."|6 weeks|FAS|||units on a scale / s||Standard Error|Mean
1372947|NCT01533935|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted mean from the MMRM model."|6 weeks|FAS|||seconds||Standard Error|Geometric Mean
1373084|NCT01532570|Secondary|Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||mm/hr||Inter-Quartile Range|Median
1372948|NCT01533935|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.|||Litres||Standard Error|Mean
1372949|NCT01533922|Secondary|Forced Expiratory Volume in 1 Second (One Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose)~The presented means are adjusted means from MMRM model."|6 weeks|FAS|||Litres||Standard Error|Mean
1372950|NCT01533922|Secondary|Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).~Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.~A decrease in slope indicates improvement.~The presented means are adjusted means from MMRM model."|6 weeks|FAS|||units on a scale / second||Standard Error|Mean
1372951|NCT01533922|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted mean from the MMRM model."|6 weeks|FAS|||seconds||Standard Error|Geometric Mean
1372952|NCT01533922|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.|||Litres||Standard Error|Mean
1372953|NCT01533753|Secondary|Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)|Assess percent change in quality of life from baseline to cycle 6, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.|over the 6 month treatment period|Zero participants analyzed due to early termination of study||||||
1372954|NCT01533753|Secondary|Assess Changes in the Hot Flash Scores for the Two Arms|Assess percentage changes in the hot flash score from baseline to cycle 6 between gabapentin and venlafaxine in men with prostate cancer treated with for hot flashes related to androgen deprivation therapy|6 month treatment period|Zero participants analyzed due to early termination of study||||||
1372955|NCT01533753|Secondary|Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups|Toxicity rates will be compared between the two groups|over a 6 month treatment period|Zero participants analyzed due to early termination of study||||||
1372956|NCT01533753|Primary|Changes in Quality of Life|We will measure the absolute change in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy|observed over a 6 month treatment period|Zero participants analyzed due to early termination of study.||||||
1372957|NCT01533688|Secondary|Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.|Number of Participants Who Developed Side Effects of Taking Bowel Preparations|24 hours||||Participants|||Count of Participants
1372958|NCT01533688|Primary|Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy.|The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist.|Day 1|We have missing data regarding reporting of Boston bowel preparation scores (BBPS), some providers didn't provide the BBPS and provided only subjective assessment of the bowel preparation (for example, good or excellent)|||Participants|||Count of Participants
1372959|NCT01533597|Secondary|Change of Qmax|maximal urinary flow rate (Qmax) assessed by uroflowmetry|at week 24 relative to baseline||||mL/sec||95% Confidence Interval|Mean
1372960|NCT01533597|Secondary|Change of PVR|Change from baseline in Post-Void Residual (PVR) volume|at week 24 relative to baseline||||mL||95% Confidence Interval|Mean
1372961|NCT01533597|Secondary|Change in Score of IPSS|Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.|at week 24 relative to baseline||||units on a scale||95% Confidence Interval|Mean
1372962|NCT01533597|Secondary|Change in Total Score of OABSS|Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)|at week 24 relative to baseline||||units on a scale||95% Confidence Interval|Mean
1372963|NCT01533597|Secondary|Numeric Change of Urgency Episodes Per 24 Hours||at week 24 relative to baseline||||episodes||95% Confidence Interval|Mean
1372964|NCT01533597|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours||at week 24 relative to baseline||||episodes||95% Confidence Interval|Mean
1375389|NCT01505764|Secondary|Resting Energy Expenditure.|% change between day 84 and baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
1372965|NCT01533493|Primary|Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)|"This is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales: Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Example item: I make careless errors when completing tasks. Items are rated 1 Never, 2 Sometimes, or 3 Often. The Global Executive Composite (GEC) Score is calculated by totaling all items on the scale. GEC T-scores range from 34-108, with higher scores indicating more difficulties with executive function."|baseline, 12 weeks||||percentage change from baseline score||Standard Deviation|Mean
1372966|NCT01533428|Secondary|Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12|Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12|Baseline to Week 12|Safety Analysis Set (SAF)|||participants|||Number
1372967|NCT01533428|Secondary|Number of Participants Who Used Rescue Pain Medication Days 1 Through 5|Summarized number of participants who used Rescue Pain Medications for Pain|Days 1 - 5|Safety Analysis Set (SAF)|||participants|||Number
1372968|NCT01533428|Secondary|"Change From Pre-application inPain Now Score"|"Change from pre-application inPain Now score was measured on a scale from 0-10 where 0 equates to No Pain and 10 to Pain as bad as you can imagine. Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment."|Pre-application and 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)|||units on a scale||Standard Deviation|Mean
1372969|NCT01533428|Secondary|Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.|Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal.|Day 1, 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)|||participants|||Number
1372970|NCT01533428|Secondary|Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12|"Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies “pain does not interfere with sleep” and 10 identifies “pain completely interferes with sleep. Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12."|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||percentage of change||Standard Deviation|Mean
1372971|NCT01533428|Secondary|Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12|"Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question Over the past 7 days, how much has the study treatment improved your pain level?"|Baseline, Weeks 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
1372972|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1372973|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1372974|NCT01533428|Secondary|Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12|Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0–100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1372975|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12|Baseline to Week 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
1373085|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (CRP) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||mg/dL||Inter-Quartile Range|Median
1372976|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8|Baseline to Week 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
1372977|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2|Baseline to Week 2|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
1372978|NCT01533428|Secondary|Percentage of Participants With 50% Reduction in Average Daily Pain Score.|Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.|||percentage of participants|||Number
1372979|NCT01533428|Secondary|Percentage of Participants With 30% Reduction in Average Daily Pain Score.|Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.|||percentage of participants|||Number
1372980|NCT01533428|Secondary|Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline|Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline and Weeks 2, 4, 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1372981|NCT01533428|Secondary|Weekly Percent Change From Baseline in Average Daily Pain Score|Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12|Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used.|||percentage change||Standard Deviation|Mean
1372982|NCT01533428|Secondary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12|Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||percentage change||Standard Deviation|Mean
1372983|NCT01533428|Primary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8|Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 to 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||percentage change||Standard Deviation|Mean
1372984|NCT01533259|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Weeks 24 and 48|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1372985|NCT01533259|Secondary|Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities|This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.|Up to 48 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
1372986|NCT01533259|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 12|Full Analysis Set: participants who received at least one dose of study drug and had no major protocol violations of study drug resistance at baseline.|||percentage of participants||95% Confidence Interval|Number
1372987|NCT01533246|Secondary|Progression Free Survival|Progression Free survival (PFS) time was measured as the time from the date of on study up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.|assessed up to 2 years|Patients that received treatment|||Months||Full Range|Median
1372988|NCT01533246|Secondary|Overall Survival Based on the RECIST v1.1|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|Up to 2 years|Patients that received treatment|||Months||Full Range|Median
1372989|NCT01533246|Secondary|Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved.|assessed up to 12 weeks|Patients that received treatment.|||months||95% Confidence Interval|Median
1372990|NCT01533246|Secondary|Number of Patients With Bidimensional Measurable Disease RECIST-based Response|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|Up to 2 years|Patients with soft tissue disease only|||participants|||Number
1372991|NCT01533246|Secondary|Incidence of Toxicities Based on CTCAE Version 4.0 Criteria|Number of patients with at least possibly related to treatment toxicities grade 3 or higher based on Common Terminology Criteria for Adverse Events.|Up to 2 years|Patients that received treatment|||participants|||Number
1372992|NCT01533246|Primary|PSA Response Analyzed Using the PCWG2 Definition|Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.|12 weeks|Patients that received treatment|||participants|||Number
1372993|NCT01533181|Other Pre-specified|Changes in Biomarker Expression|To be assessed by the Wilcoxon rank sum test.|Baseline to up to day 1 of course 3|||||||
1372994|NCT01533181|Secondary|Overall Survival (OS)|OS: Time from study enrollment to death from any cause. OS summarized similarly to PFS utilizing the K-M method.|Up to 2 years|All participants who received treatment|||months||95% Confidence Interval|Median
1372995|NCT01533181|Secondary|Incidence of Serious Adverse Events (SAEs) Possibly/Probably Definitely Related to Study Drugs|Participants with Grade 3 and 4 toxicities, possibly/probably/definitely related to study drugs. Number of Participants is per Event Category. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|1 year, 6 months|All participants who received treatment|||participants|||Number
1372996|NCT01533181|Secondary|Disease Control Rate (DCR)|DCR: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) + Progressive Disease (PD). DCR summarized using both point estimates and exact confidence intervals based on the binomial distribution by arm.|Up to 2 years|All evaluable participants at time of analysis|||participants|||Number
1372997|NCT01533181|Primary|Median Progression Free Survival (PFS)|PFS: Time from randomization to time of disease progression or death. PFS summarized with the Kaplan-Meier (K-M) method by two arms (experimental versus control). Confidence intervals for the median PFS and PFS rates at different time points to be constructed when appropriate.|Up to 6 months|All participants who received treatment|||months||95% Confidence Interval|Median
1372998|NCT01533116|Primary|AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose|AUEC0-24 - Area under the effect-time curve (AUEC) to 24 h post-dose.|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||pmol/mg Hb/h.h||Standard Deviation|Mean
1372999|NCT01533116|Primary|tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity|tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||hours||Standard Deviation|Mean
1373000|NCT01533116|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||ng.h/mL||Standard Deviation|Mean
1373001|NCT01533116|Primary|Tmax - Time to Maximum Plasma Concentration|Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||hours||Full Range|Median
1373002|NCT01533116|Primary|Cmax - Maximum Plasma Concentration|Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||ng/mL||Standard Deviation|Mean
1373003|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1375390|NCT01505764|Secondary|Appetite.|Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
1373004|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1373005|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (BIA 9-1067)|Pharmacokinetic parameters of BIA 9-1067. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
1373006|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
1373007|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1373008|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1373009|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
1373010|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
1373011|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1373012|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1373013|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (3-OMD)|Pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD). For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
1373014|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
1373015|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1373016|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
1373017|NCT01533077|Primary|Tmax - Time of Occurrence of Cmax Maximum Observed Plasma Concentration (L-DOPA)|Pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA). For tmax = time to Cmax values are presented as median with range values.|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
1373018|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
1373019|NCT01533038|Primary|Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met|"LUTS: ≥ 30% reduction in IPSS compared to baseline~Recovery Experience: Return to pre-operative activity levels by 1 month~Erectile function: Less than 6-point reduction in SHIM compared to baseline.~Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response Could not ejaculate~Continence: ISI score of 4 points or less at all follow-up time points~Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up."|Month 12||||% Responders of Participants|||Number
1373020|NCT01532999|Secondary|PTSD Remission|Total CAPS score of less than or equal to 45 at week 9 (single observation point)|Week 9|All participants who were randomized and attended at least one intervention session.|||percentage of participants|||Number
1373021|NCT01532999|Secondary|PTSD Response|Greater than or equal to 30% improvement on PTSD CAPS scale|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||percentage of participants|||Number
1373022|NCT01532999|Secondary|Change From Baseline in CAPS D Subscale|Clinician Administered PTSD Scale (CAPS) D subscale measures the hyperarousal cluster (i.e. D criterion) of PTSD symptoms and includes the items 13 - 17 of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
1373023|NCT01532999|Secondary|Change From Baseline in CAPS C Subscale|Clinician Administered PTSD Scale (CAPS) C subscale measures the avoidance and emotional numbing cluster (i.e. C criterion) of PTSD symptoms and includes the items 6 - 12 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 56 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
1373024|NCT01532999|Secondary|Change From Baseline in CAPS B Subscale|Clinician Administered PTSD Scale (CAPS) B subscale measures the re-experiencing cluster (i.e. B criterion) of PTSD symptoms and includes the first 5 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
1373025|NCT01532999|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9)|Patient Health Questionnaire (PHQ-9) is a brief 9-item measure of depressive symptoms that has established reliability and validity in community and clinical populations. All items are summed for total score ranging from 0 to 27 (higher score = more severe depression).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
1373026|NCT01532999|Secondary|Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)|"Five Facet Mindfulness Questionnaire (FFMQ) is used to evaluate the effects of MBSR vs. PCGT on mindfulness (S1). The FFMQ is a 39-item self-report instrument that assesses the general tendency to be mindful in daily life through 5 facets: observing, describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. Increases in FFMQ mediate improvements in well being in observational studies of MBSR. Each item is rated 1 to 5 (never or very rarely true to very often or always true). Some of the items are reverse scored (R). Scoring Information: Observe items:1, 6, 11, 15, 20, 26, 31, 36; Describe items: 2, 7, 12R, 16R, 22R, 27, 32, 37; Act with Awareness items: 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R; Nonjudge items: 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R; Nonreact items: 4, 9, 19, 21, 24, 29, 33. Total all subscales for score (higher score = greater degree of mindfulness). Score range 39-195 with higher=more mindfulness."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
1373027|NCT01532999|Secondary|Change From Baseline in PTSD Checklist (PCL)|"PTSD Checklist (PCL) is a 17-item self-report scale intended to measure PTSD symptom severity. The PCL has demonstrated excellent internal consistency (alpha = .94-.97), and test-retest reliability over 2 to 3 days was .96 for Vietnam veterans. Respondents rate each item from 1 (not at all) to 5 (extremely) to indicate the degree to which they have been bothered by that particular symptom over the past month. Thus, total possible scores (items summed) range from 17 to 85 (higher score is more severe). A cut-off score of 50 indicates a probable diagnosis of PTSD."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
1373028|NCT01532999|Primary|Change From Baseline in Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item standard rating scale that measures PTSD severity with scores ranging from 0-136 (higher score = more severe). Scores of frequency and intensity are summed for the 17-items to yield the total CAPS score.|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
1373157|NCT01531205|Secondary|Incidence of Perioperative and Postoperative Morbidity|Number of events. To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.|One Year|Participants who proceeded to surgery|||events|||Number
1373029|NCT01532973|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.|Up to 5 days|All participants who received at least 1 dose of study drug. Event summarized by drug taken at time of event and not by panel or genotype|||Participants|||Number
1373030|NCT01532973|Primary|Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|Up to 5 days|All participants who received at least 1 dose of study drug. Events reported by drug taken at time of event and not by panel or genotype|||Participants|||Number
1373031|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.|||IU/mL||95% Confidence Interval|Least Squares Mean
1373032|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
1373033|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
1373034|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.|||IU/mL||95% Confidence Interval|Least Squares Mean
1373035|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
1373036|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
1373037|NCT01532934|Secondary|New Criminal Charge|New criminal charge vs. no new criminal charge at follow-up as indicated by county database.|one year||||participants|||Number
1373038|NCT01532934|Secondary|Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)|A measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.|six months||||units on a scale||Standard Deviation|Mean
1373039|NCT01532934|Primary|Percent Days Abstinent Per Month From Drug Use|Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.|three to six months post baseline|105 adults (68 men and 37 women) were recruited in an urban pretrial jail diversion program. 78 (74.3%) were retained through six months. Of these, 73 were out of controlled environments (e.g., jail, inpatient treatment) for long enough to have their substance use data analyzed.|||percentage of days abstinent||Standard Deviation|Mean
1373040|NCT01532921|Secondary|Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant|The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. NYHA I implies no limitations. NYHA II implies slight limitation of physical activity. NYHA III implies marked limitation of physical activity and finally, NYHA IV implies patients are Unable to carry on any physical activity without discomfort.|Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||Participants|||Count of Participants
1373041|NCT01532921|Secondary|Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant||Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||percentage of change||Standard Deviation|Mean
1373042|NCT01532921|Secondary|Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant||Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Data were not collected||||||
1373043|NCT01532921|Secondary|Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant||Basline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted Cohort|||mm2||Standard Deviation|Mean
1373044|NCT01532921|Primary|Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant|Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant|Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||mm||Standard Deviation|Mean
1373045|NCT01532921|Primary|Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant|Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant|Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant|Implanted cohort|||mm||Standard Deviation|Mean
1373046|NCT01532921|Primary|Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant|"Change in the degree of tricuspid regurgitation measured via echocardiography from Baseline through 6 months post-implant. The severity of tricuspid regurgitation is graded by using several qualitative and quantitative methods. The degree of regurgitation is classified as none, Mild, Moderate or Severe."|Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant|Implanted cohort|||Participants|||Count of Participants
1373047|NCT01532921|Primary|Mean Gradient Across the Tricuspid Valve|The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant|At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||mmHg||Standard Deviation|Mean
1373048|NCT01532869|Secondary|Percentage of Participants With Anti-Tocilizumab Antibody||Baseline, and post-baseline (up to Week 48)|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1373049|NCT01532869|Secondary|Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||pg/mL||Standard Deviation|Mean
1373050|NCT01532869|Secondary|Mean Serum Concentrations of Interleukin (IL)-6 by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||picograms per milliliters (pg/mL)||Standard Deviation|Mean
1373051|NCT01532869|Secondary|Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)|AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (*) hour per milliliters (µg*hr/mL). It is used to characterize drug absorption.|Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16|Pharmacokinetic (PK) population included all participants who received at least one TCZ injection and had at least one PK sample with detectable results. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.|||µg*hr/mL||Standard Deviation|Mean
1373052|NCT01532869|Secondary|Change From Baseline in Tender Joint Count 28 (TJC28)|Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.|Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48|ITT population. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.|||joint count||Standard Deviation|Mean
1373061|NCT01532869|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.|Week 48|Safety population.|||percentage of participants|||Number
1373053|NCT01532869|Secondary|Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline <0) that maintained or further improved at Week 48 were reported as “Yes” and “No” with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 <= change from baseline at Week 24.|Week 48|ITT population. Here number of participants analyzed included those with mRSS change from baseline <0 at Week 24 and with non-missing change from baseline in mRSS at Week 48.|||percentage of participants|||Number
1373054|NCT01532869|Secondary|Change From Baseline in mRSS at Week 48|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at specified time point up to 48 weeks.|||unit on a scale||95% Confidence Interval|Least Squares Mean
1373055|NCT01532869|Secondary|Change From Baseline in 5-D Itch Scale at Week 24 and Week 48|The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373056|NCT01532869|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48|This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant’s condition.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373057|NCT01532869|Secondary|Change From Baseline in Patient’s Global Assessment at Week 24 and Week 48|The Patient’s Global Assessment was a patient's reported outcome that represented the participant’s overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||mm||95% Confidence Interval|Least Squares Mean
1373058|NCT01532869|Secondary|Change From Baseline in Clinician’s Global Assessment at Week 24 and Week 48|The Clinician’s Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||mm||95% Confidence Interval|Least Squares Mean
1373059|NCT01532869|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48|The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant’s self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373060|NCT01532869|Secondary|Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)|SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant’s disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant’s daily activities. Each VAS item was rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified timeframe.|||mm||95% Confidence Interval|Least Squares Mean
1373083|NCT01532570|Secondary|Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, Week 14, Week 30, Week 54||||cells/mL|||Number
1385424|NCT01402128|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/L||Standard Deviation|Mean
1373062|NCT01532869|Primary|Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0–51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants randomized who had received any study drug at the time of the Week 24 cutoff date (14 January 2014). Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at any time point up to Week 24.|||unit on a scale||95% Confidence Interval|Least Squares Mean
1373063|NCT01532830|Secondary|Mean Change in Functional Disability|Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes.|Baseline and 120 minutes|Randomized population. Data was missing for 3 patients|||units on a scale||Full Range|Mean
1373064|NCT01532830|Secondary|Mean Change in Nausea From Baseline to 120 Minutes|Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes.|Baseline 120 minutes|Randomized population. Data was missing for 3 patients|||units on a scale||Full Range|Mean
1373065|NCT01532830|Secondary|Change in Phonophobia (Auditory) From Baseline to 120 Minutes|Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.|Baseline and 120 minutes|Randomized population. Data was missing for 3 patients|||migraines with phonophobia|||Number
1373066|NCT01532830|Secondary|Change in Photophobia (Visual) From Baseline to 120 Minutes|Presence of photophobia (yes or no) was captured at baseline and 120 minutes.|Base line and 120 minutes|Randomized population. Data was missing for 3 patients|||migraines with photophobia|||Number
1373067|NCT01532830|Secondary|Mean Change in Headache Pain From Baseline to 120 Minutes|"Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes.~Data presented shows the average change from baseline to 120 minutes"|120 minutes|Randomized population. 2 subjects were excluded from the analysis due to protocol deviations|||units on a scale||Full Range|Mean
1373068|NCT01532830|Primary|Safety - Number of Participants With Adverse Effects|The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.|End of Study - 7 weeks|Randomized population|||Participants|||Count of Participants
1373069|NCT01532817|Primary|Safety- Number of Participants With Adverse Events|Safety- number of participants with adverse events, including device-related, serious or unanticipated|From time subject signs the consent through the 1-week follow-up visit|Open label study 30 participants|||Participants|||Count of Participants
1373070|NCT01532635|Secondary|Assessment for Tumor Escape Mechanisms|To test for loss of one or both HLA haplotypes in patients who relapse post-transplant and examine the relapse in the context of the characteristics of the 2 donors|1 year post transplant|||||||
1373071|NCT01532635|Secondary|Tolerance of DLI|Assessment of the tolerance of the period of fever, diarrhea, and rash after the introduction of second donor and qualitatively compare it to prior patient groups or concurrent patient groups|2-6 days prior to transplant|||||||
1373072|NCT01532635|Secondary|Non-relapse Morbidity and Mortality|Assessment of regimen related toxicity, GVHD incidence and severity, and overall survival.|1 year|||||||
1373073|NCT01532635|Secondary|Immune Reconstitution|Assess T and B cell Reconstitution|1 year|||||||
1373074|NCT01532635|Secondary|Engraftment|To assess the consistency and pace of engraftment of both donors.|1 year|||||||
1373075|NCT01532635|Secondary|Relapse Rates|To assess if establishment of a dominant donor versus persistent chimerism of both donors is associated with a lower relapse rate.|1 year|||||||
1373076|NCT01532635|Secondary|Assessment of Dominance|If dominance is observed, to compare the 2 donors with regard to degree of HLA mismatch, KIR types, CD 34+ cell doses, infusion order, donor age, and donor alloreactivity points in an effort to identify potential biologic factors that predict for dominance. To determine if trends toward dominance occur in T cell, NK cell, or other cellular subsets prior to emerging in the graft as a whole.|1 year|||||||
1373077|NCT01532635|Secondary|Chimerism Assessment|To assess chimerism to ascertain whether one donor is emerging as dominant at regular intervals beginning at the time of engraftment.|1 year|||||||
1373078|NCT01532635|Primary|One Year Relapse-Free Survival|"To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors.~Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover."|1 year|||||||
1373079|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients|"The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||participants|||Number
1373080|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients|"The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||participants|||Number
1373081|NCT01532570|Secondary|The Number of Improved Intestinal BD Patients From Baseline|"The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as  No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor.~We calculated improved patients in comparison with those for Week 0."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||participants|||Number
1373082|NCT01532570|Secondary|Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD||Week 0, Week 14, Week 30, Week 54||||pg/mL|||Number
1373086|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||mg/dL||Inter-Quartile Range|Median
1373087|NCT01532570|Secondary|Imaging Findings: CT, PET/CT for Vascular-BD|"Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, Improves, Unchanged or Worsened by comparison with those at Week 0."|Week 14, Week 30, Week 54||||participants|||Number
1373088|NCT01532570|Secondary|Imaging Findings: Brainstem MRI for Chronic Neuro-BD|"Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, Unchanged or Reduced in the brainstem area compared to Week 0."|Week 14, Week 30, Week 54||||participants|||Number
1373089|NCT01532570|Secondary|Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD|"Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, No high-intensity areas, Reduction or No changes/increase in the size of high-intensity areas compared to Week 0."|Week 14, Week 30, Week 54||||participants|||Number
1373090|NCT01532570|Secondary|Imaging Findings:Endoscopic Examination for Intestinal BD|"The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, Healed/scarred, Reduced to =< 25%, Reduced to > 25% to =< 50% or Reduced to > 50%/no change/increased in the principal intestinal ulcer compared to size at Week 0."|Week 14, Week 30, Week 54||||participants|||Number
1373091|NCT01532570|Secondary|Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD|"The VAS evaluation measured using the General VAS evaluation From and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as 0 and the worst condition is defined as 100.~The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||units on a scale||Standard Deviation|Mean
1373092|NCT01532570|Secondary|Percentage of Participants With Complete Response at Week 14 and 54|"We defined the patient who met the following criteria as the complete responders.~The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 14, Week 54||||percentage of Complete Responders|||Number
1373093|NCT01532570|Primary|Percentage of Participants With Complete Response at Week 30|"We defined the patient who met the following criteria as the complete responders.~The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 30||||percentage of Complete Responders|||Number
1373094|NCT01532453|Secondary|Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas||2 Years|"The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.~For patient 10018 (MD-3511356 group) the age of first organ transplant was not computable due to missing date."|||percentage of patients|||Number
1373095|NCT01532453|Primary|Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas||2 Years|241 patients were randomized: 160 to the MD 3511356 group and 81 to the standard care group. All 241 randomized patients received at least one dose of trial device and therefore were all included in the safety population. The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.|||new actinic keratoses or scc||Standard Deviation|Mean
1373096|NCT01532414|Primary|Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT.|||percentage of participants|||Number
1373097|NCT01532414|Primary|Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range|"Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 – 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.|||Percentage of Subjects|Participants|95% Confidence Interval|Number
1373098|NCT01532362|Secondary|Effect of Apricoxib on Levels of CD4+CD25+ T Regulatory Cells in Peripheral Blood.Also,Biomarkers of Apoptosis Resistance,Angiogenesis,Invasion and Immunity Will be Tested in the Lab to Check How Effective Apricoxib is in Inhibiting These Proteins.|Peripheral blood from patients with NSCLC has been reported to have an increase in the percentages of CD4+CD25+ T reg cells.In contrast <10% of the PBLs of normal donors have this phenotype. As such, CD4+CD25+ cells will be assessed in addition to FOXP3 levels in PBL. In addition, exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity will be studied. COX-2, FOXP3, IL-10, IL-12, MDC, CXCR4 and survivin will be analyzed in plasma.|7 days|||||||
1373380|NCT01528332|Secondary|Frequency, Severity, Nature and Duration of Adverse Events During the Whole Duration of the Study|Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.|Baseline (days -7 to -1) to Follow up (up to day +42)|||||||
1373099|NCT01532362|Primary|Compare Level of CD4+CD25high T Lymphocyte Regulatory Cells in Peripheral Blood Lymphocytes and Tumor Infiltrating Lymphocytes From Surgical Resection Specimens of Subjects With Early Stage NSCLC Who Have Received Apricoxib to Those Who Have Not|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision). Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7|7 days|No analysis occurred||||||
1373100|NCT01532349|Primary|Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease|The null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat.|change from baseline to up to three months||||ng/ml||Inter-Quartile Range|Median
1373101|NCT01532141|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng.h/mL||Standard Deviation|Mean
1373102|NCT01532141|Secondary|Time of Occurrence of Cmax (Tmax)|6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers|pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||hours||Full Range|Median
1373103|NCT01532141|Primary|Cmax - Maximum Observed Plasma Drug Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng/mL||Standard Deviation|Mean
1373104|NCT01532128|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng.h/mL||Standard Deviation|Mean
1373105|NCT01532128|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||hours||Full Range|Median
1373106|NCT01532128|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng/mL||Standard Deviation|Mean
1373107|NCT01531998|Secondary|Number of Participants With Response|Overall response defined as number of participants with International Myeloma Working Group Uniform Response Criteria: Complete Response (CR): Negative immunofixation serum & urine, Disappearance soft tissue plasmacytomas & =/<5% plasma cells in bone marrow; Stringent Complete Remission: CR + Normal Normal free light chain (FLC) ratio & Absence clonal cells in bone marrow by Immunohistochemistry/ immunofluorescence; Very Good Partial Response (VGPR): Serum & urine M-protein detectable by immunofixation but not on electrophoresis or 90%> reduction in serum M-protein +urine M-protein level <100mg per 24 hour; Partial Remission (PR): =/>50% reduction serum M-protein & reduction in 24-hour urinaryMprotein by >90% or to < 200mg per 24 hour, =/>50% reduction of serum M-protein & reduction in 24-hour urinary Mprotein by >90%/or <200mg, and if present at baseline, a >50% reduction in size of soft tissue plasmacytomas; Stable Disease: Not CR, VGPR, PR Or Progressive disease|Evaluated after eight cycles of 21 days.||||participants|||Number
1373108|NCT01531998|Primary|Maximum Tolerated Dose (MTD) of Siltuximab|Maximum tolerated dose (MTD) defined as follows: At first dose level, if greater than 1 out of 3 patients or greater than 1 out of 6 patients experience dose limiting toxicity (DLT), the dose level exceeds the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) defined as toxicities graded in severity according to the guidelines outlined in the NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.|21 days||||mg/kg|||Number
1373109|NCT01531725|Secondary|Major Adverse Cardiac Events (MACE)|MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.|at 180 days post procedure|Patients with follow up available either 180 or 360 days post procedure.|||participants|||Number
1373110|NCT01531725|Primary|Target Vessel Failure (TVF)|Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.|at 180 days post procedure|Patients with follow up data available either 180 or 360 days post procedure.|||participants|||Number
1373111|NCT01531673|Secondary|AUC0-24h of VX-661 and AUC0-12h of Ivacaftor After Administration of VX-661 in Combination With Ivacaftor|Participants who received VX-661 in combination with Ivacaftor (Group 2b, 3b, 4, 5b, 6a, 6d and 7) were analyzed for this outcome measure. PK analysis was not planned for placebo reporting arms.|Day 28|The analysis was done using PK Set.|||ng*h/mL||Standard Deviation|Mean
1373112|NCT01531673|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24h) of VX-661 After Administration of VX-661 Monotherapy|Participants who received VX-661 monotherapy (Group 1, 2a, 3a and 5a) were analyzed for this outcome measure. PK analysis (AUC0-24h) was not planned for placebo reporting arms.|Day 28|The analysis was done using Pharmacokinetics (PK) Set.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1373113|NCT01531673|Secondary|Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 14, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373125|NCT01531673|Primary|Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline through Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint.|||mmol/L||95% Confidence Interval|Least Squares Mean
1373381|NCT01528332|Secondary|Change From Treatment in RMDQ at Follow up||Treatment (days +1 to +14) to Follow up (up to day +42)|||||||
1373114|NCT01531673|Secondary|Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 14, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373115|NCT01531673|Secondary|Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 14, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373116|NCT01531673|Secondary|Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug.|||Liters||95% Confidence Interval|Least Squares Mean
1373117|NCT01531673|Secondary|Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||Liters||95% Confidence Interval|Least Squares Mean
1373118|NCT01531673|Secondary|Change in FEV1 (Liter [L]) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||Liters||95% Confidence Interval|Least Squares Mean
1373119|NCT01531673|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1373120|NCT01531673|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1373121|NCT01531673|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1373122|NCT01531673|Secondary|Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 7|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||mmol/L||95% Confidence Interval|Least Squares Mean
1373123|NCT01531673|Secondary|Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 6|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||mmol/L||95% Confidence Interval|Least Squares Mean
1373124|NCT01531673|Secondary|Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 1-5b|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||mmol/L||95% Confidence Interval|Least Squares Mean
1373126|NCT01531673|Primary|Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline through Day 28|The analysis was done using Full Analysis Set (FAS) which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint.|||mmol/L||95% Confidence Interval|Least Squares Mean
1373127|NCT01531673|Primary|Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline through Day 28|The analysis was done using Full Analysis Set (FAS) which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1373128|NCT01531673|Primary|Safety as Determined by Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the Informed Consent Form is signed. AE includes serious as well as non-serious AEs. Serious Adverse Event (SAE) is any AE that results in any of the following: death; life-threatening condition; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or other important medical event. Treatment-emergent adverse events are defined as adverse events that were reported or worsened on or after start of study drug through the Follow-up Visit (28 days after last dose of study drug) or premature discontinuation.|Start of study drug through the Follow-up Visit (Up to Day 56)|Analysis was done using safety set which included all participants who received at least 1 dose of study drug.|||participants|||Number
1373129|NCT01531387|Secondary|Quality of Life|Standard Quality of Life measure will be taken during specific time points, as well as one newly-developed Sickle Cell Disease Quality of Life measure.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
1373130|NCT01531387|Secondary|Cumulative Incidence of Non-Neurological Events|The cumulative incidence of non-neurological sickle cell-related events, including vaso-occlusion and splenic sequestration, will be estimated over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
1373131|NCT01531387|Secondary|Cumulative Incidence of Neurological Events|The cumulative incidence of neurological events as a secondary endpoint, which include both stroke and non-stroke neurological events, will be determined over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
1373132|NCT01531387|Secondary|Serial TCD Velocities|This secondary outcome measure will be the highest TAMV obtained in specific arteries. Serial TCD velocities are measured throughout the SCATE trial and will be compared to the baseline value.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
1373133|NCT01531387|Primary|Conversion to Abnormal Maximum TAMV|The primary endpoint of the SCATE trial is the cumulative incidence of conversion to abnormal maximum TAMV (time-averaged mean velocity) measured by transcranial doppler (TCD) ultrasonography. Subjects must have conditional velocities at baseline, defined as 170 - 199 cm/sec, which indicate moderate stroke risk. Abnormal velocities are defined as ≥ 200 cm/sec, which indicate high stroke risk. The number of conversions from conditional velocities to abnormal velocities in each treatment arm will be compared as the primary outcome.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the primary outcome measure was not analyzed.||||||
1373134|NCT01531374|Secondary|Prosthetic Valve Dysfunction (PVD)|"PVD was defined according to VARC using the site reported echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:~Peak velocity >4 m/s~Mean gradient >35 mmHg~EOA < 0.8 cm2~TVIV1 / TVIV2 < 0.25"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.|||Percentage of participants|||Number
1373135|NCT01531374|Secondary|Procedural Success|Defined as device success and absence of in-hospital MACCE.|Number of days from admission to discharge|Participant Population = Consisted of all subjects with an index procedure who were evaluable for procedural success.|||percentage of participants|||Number
1373136|NCT01531374|Secondary|Device Success|"Defined as:~Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,~Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),~Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)~Only one valve implanted in the proper anatomical location"|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.|||percentage of participants|||Number
1373137|NCT01531374|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge|Participant Population = Consisted of all subjects with an attempted implant procedure.|||days||Standard Deviation|Mean
1373138|NCT01531374|Secondary|Index Procedure Related MAEs||Procedure|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants|||Number
1373139|NCT01531374|Secondary|Strokes and Transient Ischemic Attacks (TIAs)|Strokes (of any severity) and TIAs|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1373142|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.|||percentage of participants|||Number
1373143|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~• Transvalvular Mean Gradient analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population= Consisted of all subjects with a valve implanted.|||mmHg||Standard Deviation|Mean
1373144|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~• Effective Orifice Area (EOA) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.|||cm^2||Standard Deviation|Mean
1373145|NCT01531374|Secondary|Quality of Life (QoL) Change|"QoL summary score change from baseline using the following measures:~Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||units on a scale||Standard Deviation|Mean
1373146|NCT01531374|Secondary|Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive||1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||ratio of days alive and out of hospital||Standard Deviation|Mean
1373147|NCT01531374|Secondary|Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|Baseline to 30 days, baseline to 1 year|Participant Population = Consisted of all subjects with an attempted implant procedure.|||meters||Standard Deviation|Mean
1373148|NCT01531374|Secondary|Change From Baseline in NYHA Class|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.~NYHA Classification:~Class I: Subjects with cardiac disease but without resulting limitations of physical activity.~Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||average classification level change||Standard Deviation|Mean
1373149|NCT01531374|Secondary|Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1373150|NCT01531374|Secondary|Major Adverse Events (MAEs)|"MAEs Include:~MACCE~Acute Kidney Injury~Cardiac Tamponade~Prosthetic Valve Dysfunction~Cardiogenic Shock~Valve Endocarditis~Life-Threatening, Disabling or Major Bleeding~Major Vascular Complication~Cardiac Perforation~Device Migration/Valve Embolism"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1373151|NCT01531374|Secondary|The Occurrence of Individual MACCE Components|"Individual MACCE Components Include:~All Cause Mortality~MI~All stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1373152|NCT01531374|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~All-Cause Death~Myocardial Infarction (MI)~All Stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1373153|NCT01531374|Primary|Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality|All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)|1 year|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1373154|NCT01531335|Secondary|Insulin Requirements|This is an indirect measure of glycemic control, and is reported as a daily average.|Daily until day 21 or discharge from ICU||||International Unit of insulin||Standard Deviation|Mean
1373155|NCT01531335|Primary|SOFA (Sequential Organ Failure Assessment) Score|SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).|48 hours since nutritional regime starts||||units on a scale||Standard Deviation|Mean
1373382|NCT01528332|Secondary|Change From Baseline in RMDQ at Follow up||Baseline (days -7 to +1) to Follow-up (up to day +42)|||||||
1373158|NCT01531205|Secondary|Incidence of Complete Response (CR)|Percentage of participants with CR post surgery. To evaluate the pathological complete response rate to androgen ablation plus Cabazitaxel in patients with locally recurrent prostate cancer following radiation therapy. Pathological Complete Response (pCR): Participants with no residual cancer in the local resection specimen and pelvic lymph nodes will be considered pCR.|One Year|Participants who proceeded to surgery|||percentage of participants|||Number
1373159|NCT01531205|Secondary|Incidence of PSA Progression Free Survival (PFS)|Percentage of participants with stable (has not increased) or undetectable PSA post surgery. To assess Prostate-specific antigen(PSA)-progression free survival and prostate cancer specific survival for patients treated by chemohormonal therapy followed by salvage surgery for biopsy proven androgen-dependent high-risk locally recurrent prostate cancer following radiation therapy.|Four Months|Participants who proceeded to surgery|||percentage of participants|||Number
1373160|NCT01531205|Primary|Surgical Margin Negative Rate (SM Rate)|Post surgery percentage of participants with negative surgical margin. To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy. Margin: The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|One Year|Participants who proceeded to surgery|||percentage of participants|||Number
1373161|NCT01530997|Secondary|The Rosenbek Penetration Aspiration Scale|"The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances.~1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject."|Prior to CRT and 4-8 weeks after completion of CRT||||units on a scale||Standard Deviation|Mean
1373162|NCT01530997|Secondary|The Eating Assessment Tool (EAT-10) Composite Score|The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40.|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT||||units on a scale||95% Confidence Interval|Mean
1373163|NCT01530997|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL|The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT||||units on a scale||95% Confidence Interval|Mean
1373164|NCT01530997|Secondary|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35|"The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality.~The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning)."|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT||||units on a scale||95% Confidence Interval|Mean
1373165|NCT01530997|Secondary|Overall Survival Rate|The percentage of participants who are still alive from the start of treatment.|Median follow-up was 36 months with a range of 5-53 months.||||percentage of participants|||Number
1373166|NCT01530997|Secondary|Distant Metastases Free Survival|Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.|the median follow-up was 36 months with a range of||||percentage of participants|||Number
1373167|NCT01530997|Secondary|Cause-Specific Survival|Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.|The median follow-up was 36 months with a range of 5-53 months||||percentage of participants|||Number
1373168|NCT01530997|Secondary|Regional Control|Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.|Median follow-up was 36 months with a range of 5-53 months||||percentage of participants|||Number
1373169|NCT01530997|Secondary|Two-Year Local Control|Local control is the arrest of cancer growth at the site of origin.|Median follow-up was 36 months with a range of 5-53 months||||percentage of participants|||Number
1373184|NCT01530334|Secondary|Treatment Duration With Gefitinib|Treatment duration was calculated from the date of the first to the date of the last intake.|every 6 weeks after the Start of Study Treatment until discontinuation of drug or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population|||days|Participants|95% Confidence Interval|Median
1373170|NCT01530997|Primary|Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).|Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.|6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened|Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated.|||Participants|||Count of Participants
1373171|NCT01530880|Secondary|Bleeding Incidence|Incidence of bleeding (defined by a priori criteria)|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.||||||
1373172|NCT01530880|Secondary|Difference in Cost Between Ibuprofen and Acetaminophen|Cost analysis of aggressive fever control (AFC) between patients randomized to either intravenous ibuprofen infusion or standard of care (oral acetaminophen).|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.||||||
1373173|NCT01530880|Secondary|Mean Difference in Inflammatory Markers|Mean difference in markers of inflammation between IV ibuprofen and standard of care groups|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.||||||
1373174|NCT01530880|Primary|Prevalence of Fever Burden|Reduction in fever burden (degrees C x hours) with intravenous ibuprofen infusion as compared to oral acetaminophen over duration of treatment. Fever burden is calculated hourly by subtracting each patient's recorded temperature (from either a bladder or esophageal temperature probe) from 37 degrees C.|Up to14 days|PI left before data could be analyzed and data collection was incomplete.||||||
1373175|NCT01530477|Primary|Short Term Precision Comparison Across Three DXA Devices|"BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the Skeletal & Body Composition cohort identified in participant flow and overall study summary will not have an analysis provided."|Less than 6 months||||Percentage of variance|||Number
1373176|NCT01530464|Primary|Area Under the Curve Post Dosing (AUC_0-infinity) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing||||h*ng/ml||Standard Deviation|Median
1373177|NCT01530464|Primary|Area Under the Curve Within 24 Hours Post Dosing (AUC_0-24 Hours) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing||||h*ng/ml||Standard Deviation|Median
1373178|NCT01530464|Primary|Maximum Plasma Concentration (Cmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)|24h after dosing||||ng/ml||Standard Deviation|Median
1373179|NCT01530464|Primary|Time Until Maximum Plasma Concentration (Tmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing||||hours||Standard Deviation|Median
1373180|NCT01530464|Primary|Plasma Halflife of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24 hours after dosing||||hours||Standard Deviation|Median
1373181|NCT01530464|Primary|Mean Number of Adverse Events Following Each Dose|"Dosing schedule:~Aminophylline Alone (Single Dose of 500mg Aminophylline) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan and Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)"|48 h following each dose||||Mean number of adverse events||Standard Deviation|Mean
1373182|NCT01530399|Primary|Chest Tube Drainage at 12 Hours After Surgery||12 hours post CABG||||mL||Inter-Quartile Range|Median
1373183|NCT01530334|Secondary|Time to Worsening of Disease Related Symptoms|Time to worsening of disease related symptoms (LCS) Time to worsening of disease-related symptoms based on FACT-L LCS was defined as the interval from the date of enrollment to the first visit response of ‘worsened’ without a subsequent response of ‘improved’ or ‘no change’ within 21 days (or to the last assessment), death due to any cause, or early discontinuation from the study. Time to worsening was censored at the last non-missing assessment visit if the worsening was not observed.|every 6 weeks after the Start of Study Treatment until the worsening of desease related symptoms or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population|||days|Participants|95% Confidence Interval|Median
1373240|NCT01529385|Primary|Ankle Edema|The circumference of ankle was measured by a tape measure.|change from baseline after 4 weeks of sock usage||||cm||95% Confidence Interval|Mean
1373185|NCT01530334|Secondary|Overall Survival (OS)|OS was calculated as the time from the first dose until the day of death from any cause. Any patient not known to have died at the time of data analysis was censored at the time of the last follow-up date.|every 6 weeks after the Start of Study Treatment until death or time of data cut off (6 months after the last patient has started study treatment)|Analysis conducted both in FAS and EFS population|||days|Participants|95% Confidence Interval|Median
1373186|NCT01530334|Secondary|Progression Free Survival|Progression free Survival was calculated as the time from the first dose of gefitinib study treatment until the date of (i) progression or (ii) death from any cause in the absence of progression.|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|PFS was analysed on FAS and EFS population|||Days|Participants|95% Confidence Interval|Median
1373187|NCT01530334|Primary|Clinical Benefit Rate|"Clinical benefit rate is the sum of patients with a best visit response of Complete Response, Partial Response or Stable Desease Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.~Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions, Stable Desease (SD) defined as no progression for>= 6 weeks. Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|CBR was analyzed both on FAS and EFS population|||Patients|Participants||Number
1373188|NCT01530334|Primary|Objective Response Rate|"Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.~Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions; Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed both in the FAS population (i.e. all enrolled patients into the study) and in EFS population (i.e. all screened patients who entered and received at least one dose of study agent)|||Patients|Participants||Number
1373189|NCT01530243|Other Pre-specified|Pain|The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain.|Expected 2 weeks later||||units on a scale||Standard Deviation|Mean
1373190|NCT01530243|Secondary|Quality of Life|The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.|Expected 2 weeks later||||units on a scale||Standard Deviation|Mean
1373191|NCT01530243|Primary|Lower Urinary Tract Symptoms (LUTS)|LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.|Expected average of 2 weeks|The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.|||units on a scale||Standard Deviation|Mean
1373192|NCT01530178|Primary|Better Targeted Blood Glucose Levels|The current trial is designed to detect a significant difference in the mean glucose levels in the treatment group|1 Year||||mg/dl||Standard Deviation|Mean
1373193|NCT01530087|Secondary|Security|wear time leakage barrier erosion|30 days|Study was stopped ; no data are available||||||
1373194|NCT01530087|Primary|Peristomal Skin Condition|mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)|1 - 30 days|Study was stopped due to inability to inability to enroll. No data are available for any outcome measures.||||||
1373195|NCT01529827|Secondary|Median Time to Neutrophil Engraftment|Median time to recovery of absolute neutrophil count >=500/uL for 3 consecutive days. Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.|Day 100|All treated and eligible patients|||days||Full Range|Median
1373196|NCT01529827|Secondary|Progression Free Survival (PFS) at One Year|Assessed using Kaplan Meier and Proportional Hazards|day of transplant until progression up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1373197|NCT01529827|Secondary|Clinical Response|"Patients will be followed according to response criteria as referenced in BMT SOP Standards of Therapy last updated 2008. Clinical Response = CR + PR.~Complete Response Requires all of the following:~Serum and urine negative for monoclonal proteins by immunofixation~Normal free light chain ratio~Plasma cells in marrow < 5%~Partial Response (PR) Requires any of the following:~- ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL or urine light chain levels > 100 mg/day with a visible peak or free light chain levels > 10mg/dL~Progressive Disease (PD) Requires any of the following:~If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)~If progressive from PR or SD, ≥ 50% increase in the serum M protein to > 0.5 g/dL,or ≥ 50% increase in urine M protein to > 200mg/day with visible peak present.~Free light chain increase of ≥ 50% to"|In the first 100 days from day 0 of transplant|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1373198|NCT01529827|Primary|Transplant Related Mortality (TRM)|Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided.|In the first 100 days from day 0 of transplant|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1373199|NCT01529645|Primary|Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination|The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||percentages of subjects||95% Confidence Interval|Number
1373241|NCT01529385|Primary|Calf Edema|The circumference of calf was measured by a tape measure.|change from baseline after 4 weeks of sock usage||||cm||95% Confidence Interval|Mean
1373383|NCT01528332|Secondary|Change From Treatment in VAS Pain Intensity at Follow up||Treatment (day +1 to +14) to Follow-up (up to day +42)|||||||
1373200|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1373201|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1373202|NCT01529645|Primary|Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1373203|NCT01529645|Secondary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens|The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.|Day 30 post vaccination/Day 1|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1373204|NCT01529645|Secondary|GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination|The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
1373205|NCT01529645|Secondary|Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.|Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.|Day 30 post vaccination|Analysis was done on the per-protocol population.|||percentage of subjects||95% Confidence Interval|Number
1373206|NCT01529645|Primary|GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||µg/mL||95% Confidence Interval|Geometric Mean
1373207|NCT01529645|Primary|GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||µg/mL||95% Confidence Interval|Geometric Mean
1373208|NCT01529645|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding.|||µg/mL||95% Confidence Interval|Geometric Mean
1373209|NCT01529645|Primary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.|From day 1 to day 365|Analysis was done on the safety set.|||participants|||Number
1373210|NCT01529645|Primary|The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.|Day 1 through 7 after vaccination|Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.|||participants|||Number
1373211|NCT01529632|Secondary|Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment|The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of 'nights with no nighttime awakenings'. The symptom variables for the whole active treatment period was analyzed using the similar MIXED model as for the primary endpoint, with the baseline FEV1 term being replaced by the respective baseline symptom variables.|28 days|The Modified per protocol set (PPS) was defined post-DBL and included all patients with available data and without any major protocol deviations or criteria or GCP finding causing exclusion. Patients were analyzed according to the treatment to which they were randomized.|||percentage of days||Standard Deviation|Mean
1373242|NCT01529385|Primary|Cutaneous Water Content|Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.|change from baseline after 4 weeks of sock usage||||percentage change in dielectric constant||95% Confidence Interval|Mean
1373212|NCT01529632|Secondary|Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening) then a half day was used in the denominator.|Baseline and 28 days|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||puffs||Standard Deviation|Mean
1373213|NCT01529632|Secondary|Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28|Time course of Forced Expiratory Volume in 1 second (FEV1) was measured at -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|-45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28|The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
1373214|NCT01529632|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 min - 4 hr at Days 1 and 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
1373215|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 28 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
1373216|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
1373217|NCT01529632|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 29|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
1373218|NCT01529515|Secondary|Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase|The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||Units on a Scale||Standard Deviation|Mean
1373219|NCT01529515|Secondary|Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase|The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||Units on a Scale||Standard Deviation|Mean
1373272|NCT01529268|Secondary|Resolution of NASH|Patients with a change from a histological diagnosis of definite NASH or indeterminate for NASH to not NASH at end of treatment|52 weeks|Analysis was limited to patients with a diagnosis of definite NASH at baseline.|||participants|||Number
1373220|NCT01529515|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||Units on a Scale||Standard Deviation|Mean
1373221|NCT01529515|Primary|Time to Relapse During the Double-Blind Phase|Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.|Approximately Week 60|The intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least one dose of Double-blind study agent.|||Days||95% Confidence Interval|Median
1373222|NCT01529502|Other Pre-specified|Endothelial Function|To assess Endothelial function by RHI at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
1373223|NCT01529502|Other Pre-specified|Changes in Gene Expression|To assess concentration of changes in gene expression at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
1373224|NCT01529502|Other Pre-specified|Activation of Inflammatory Lipid Mediators|To assess concentration of plasma activation of inflammatory lipid mediators at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
1373225|NCT01529502|Other Pre-specified|Activation of Platelets|To assess concentration of plasma activation of platelets at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
1373226|NCT01529502|Other Pre-specified|Concentration of Cytokines|To assess concentration of plasma cytokines at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
1373227|NCT01529502|Other Pre-specified|Nitric Oxide Metabolites|To assess concentration of plasma Nitric oxide metabolites at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
1373228|NCT01529502|Other Pre-specified|Hemolysis|To assess concentration of plasma Hemoglobin at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|before and after blood transfusion|||||||
1373229|NCT01529502|Secondary|Endothelial Function: Reactive Hyperemia Index|Reactive Hyperemia Index (RHI) measures Endothelial function and is assessed by digital pulse amplitude tonometry and it is a sensitive indicator of endothelial function. RHI is a calculated as a ratio between tested versus contralateral finger dilatation, thus there is no unit measure.|Post-transfusion||||LnRHI||Standard Error|Mean
1373230|NCT01529502|Primary|Systolic Pulmonary Artery Pressure|Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography|Post-transfusion|"In the fresh blood only 9 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully studied by trans-thoracic echocardiography. In the old blood only 11 volunteers and In the old blood + Inhaled Nitric Oxide only 12 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully evaluated."|||mmHg||Standard Error|Mean
1373231|NCT01529450|Secondary|Molecular Markers Associated With Clinical Response|Following consent, historical biopsy samples were analyzed for molecular markers associated with clinical response. Tumors were analyzed and present of Smooth mutation (SMO [genetic changes which influence Ki 67 and Gli levels]). was determined. The number of participants with and without SMO were reported by clinical outcome (SD = stable disease; PD = progressive disease).|Assessed on day 1|Participants with tissue available for screening were analyzed.|||participants|||Number
1373232|NCT01529450|Primary|Progression Free Survival (PFS) of All Participants||End of treatment or at time of disease progression (up to 58 weeks)|Progression is defined using RECIST version 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion or the appearance of new lesion.|||weeks||95% Confidence Interval|Median
1373233|NCT01529385|Primary|Microcirculation for Dorsum of Foot|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage||||mmHg||95% Confidence Interval|Mean
1373234|NCT01529385|Primary|Microcirculation for Lateral Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage||||mmHg||95% Confidence Interval|Mean
1373235|NCT01529385|Primary|Microcirculation for Medial Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage||||mmHg||95% Confidence Interval|Mean
1373236|NCT01529385|Secondary|Physical Activity Level|Physical activity monitors will be used to assess physical activity patters of participants for 48 hours prior to initiating sock usage and for 48 hours after the participants have worn the socks for four weeks.|baseline and after four weeks of wearing the socks|physical activity measurements were only made for a sub-sample of the study's complete sample|||steps||Standard Deviation|Mean
1373237|NCT01529385|Primary|Foot Edema|The circumference of the foot was measured by a tape measure.|change from baseline after 4 weeks of sock usage||||cm||95% Confidence Interval|Mean
1373238|NCT01529385|Primary|Ankle Brachial Index|ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage||||unit-less ratio data||95% Confidence Interval|Mean
1373239|NCT01529385|Primary|Toe Brachial Index|ratio of systolic blood pressure of toe relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage||||unit-less ratio data||95% Confidence Interval|Mean
1373243|NCT01529346|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Clinically significant ECG abnormalities: PR interval >=300 milliseconds (msec); 25% increase from baseline in PR interval when baseline PR was >200 msec; an increase from baseline of >=50% in PR interval when baseline PR was <=200 msec; QRS interval >=140 msec; an increase from baseline of >=50% in QRS interval; corrected QT interval (QTc) >=500 msec.|Baseline up to Day 7 to 10 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1373244|NCT01529346|Secondary|Number of Participants With Clinically Significant Vital Signs|Clinically significant vital signs: supine/sitting pulse rate (PR) less than (<) 40 or more than (>) 120 beats per minute (bpm), standing PR <40 or >140 bpm; systolic blood pressure (BP) >=30 millimeters of mercury (mmHg) change from baseline; absolute systolic BP <90 mmHg; diastolic BP >=20 mmHg change from baseline; absolute systolic BP <50 mmHg.|Baseline up to Day 7 to 10 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1373245|NCT01529346|Secondary|Number of Participants With Clinically Significant Laboratory Findings|Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes), blood chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, blood urea nitrogen, fasting glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase), and urinalysis (urine white blood cells, urine red blood cells) were performed.|Baseline up to Day 7 to 10 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1373246|NCT01529346|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 28 days that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 28 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1373247|NCT01529346|Secondary|Plasma Ibuprofen Concentration|Ibuprofen concentration was reported separately for 2 isomers of ibuprofen: (S)-Ibuprofen, and (R)-Ibuprofen, where S implied sinister (clockwise configuration) and R implied rectus (anti-clockwise configuration).|0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose|Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1373248|NCT01529346|Secondary|Plasma PF-05089771 Concentration||0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose|Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1373249|NCT01529346|Secondary|Number of Participants With Study Medication Satisfaction|Participants provided assessment regarding satisfaction with study medication (SM) for pain relief (PR) and overall performance (OP) on a 5-point categorical scale, 1=very dissatisfied (VD), 2=somewhat dissatisfied (SD), 3=neither satisfied nor dissatisfied (NSND), 4=somewhat satisfied (SS) and 5=very satisfied (VS).|6, 24 hours, prior to rescue medication (assessed up to 24 hours)|FAS: all randomized participants who received >=1 dose of study treatment, had >=1 evaluable (>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure.|||participants|||Number
1373250|NCT01529346|Secondary|Number of Participants With Global Evaluation of Study Medication|Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication[RM]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent.|6, 24 hours, prior to rescue medication (assessed up to 24 hours)|FAS: all randomized participants who received >=1 dose of study treatment, had >=1 evaluable (>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure.|||participants|||Number
1373251|NCT01529346|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||hours||90% Confidence Interval|Median
1373252|NCT01529346|Secondary|Time to Onset of Meaningful Pain Relief|Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief.|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||hours||90% Confidence Interval|Median
1373253|NCT01529346|Secondary|Time to Onset of First Perceptible Pain Relief|Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief.|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||hours||90% Confidence Interval|Median
1373287|NCT01529203|Primary|Subject Satisfaction for the Full Face|based on the subject's satisfaction questionnaire|Month 6|only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis|||percentage of total subjects|||Number
1373384|NCT01528332|Secondary|Change From Baseline in VAS Pain Intensity at Follow up||Baseline (day -7 to 1) to Follow-up (up to day +42)|||||||
1373254|NCT01529346|Secondary|Total Pain Relief From 0 to 24 Hours (TOTPAR[24])|TOTPAR(24) was defined as the total area under the PR curve through the first 24 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1373255|NCT01529346|Secondary|Summed Pain Intensity Difference (SPID)|SPID: area under the PID effect curve from 0 to 6 hours (SPID[6]) and 0 to 24 hours (SPID[24]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe).|0 to 6 hours; 0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1373256|NCT01529346|Secondary|Pain Intensity Difference (PID)|PID was calculated as pain intensity at baseline (baseline pain severity score range 2 [moderate] to 3 [severe]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 [none] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||units on a scale||Standard Error|Least Squares Mean
1373257|NCT01529346|Secondary|Pain Relief (PR) Score|PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||units on a scale||Standard Error|Least Squares Mean
1373258|NCT01529346|Secondary|Number of Participants With Peak Pain Relief (PPR)|PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||participants|||Number
1373259|NCT01529346|Primary|Total Pain Relief From 0 to 6 Hours (TOTPAR[6])|TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.|0 to 6 hours|Full Analysis Set (FAS): all randomized participants who received at least (>=) 1 dose of study treatment and had >=1 evaluable (more than or equal to [>=] 90 minutes post-dose) PR score. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1373260|NCT01529268|Secondary|Reduction in MRI-determined Hepatic Fat Fraction|Change from baseline in MRI Proton Density Fat Fraction (PDFF) (%).|52 weeks|The smaller number of observations is because MRI was an optional procedure. This is the number with MRI exams at both baseline and 52 weeks.|||percentage of PDFF||Standard Deviation|Mean
1373261|NCT01529268|Secondary|Change in Pediatric Quality of Life Inventory (PedsQL) Score|Pediatric Quality of Life Inventory (PedsQL) version 4.0 is completed by both the child and parent/caregiver, and is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales.|52 weeks||||units on a scale||Standard Deviation|Mean
1373262|NCT01529268|Secondary|Change in Diastolic Blood Pressure||52 weeks||||mmHg||Standard Deviation|Mean
1373263|NCT01529268|Secondary|Change in Systolic Blood Pressure||52 weeks||||mmHg||Standard Deviation|Mean
1373264|NCT01529268|Secondary|Change in HOMA-IR|(Glucose (mmol/L) x insulin (pmol/L))/22.5|52 weeks||||(10E-15 mol^2)/L^2||Standard Deviation|Mean
1373265|NCT01529268|Secondary|Change in Fasting Insulin||52 weeks||||μU/mL||Standard Deviation|Mean
1373266|NCT01529268|Secondary|Change in Fasting Serum Glucose||52 weeks||||mg/dL||Standard Deviation|Mean
1373267|NCT01529268|Secondary|Change in Waist Circumference||52 weeks||||cm||Standard Deviation|Mean
1373268|NCT01529268|Secondary|Change in Body-mass Index Z-score||52 weeks||||SD||Standard Deviation|Mean
1373269|NCT01529268|Secondary|Change in Body-mass Index||52 weeks||||kg/m^2||Standard Deviation|Mean
1373270|NCT01529268|Secondary|Change in Weight (kg)||52 weeks|Smaller number of patients analyzed due to missing 52-week weight measurement.|||kg||Standard Deviation|Mean
1373271|NCT01529268|Secondary|Change in Serum Aminotransferase and Gamma-glutamyl Transpeptidase||52 weeks|The smaller number of participants analyzed is due to missing 52-week laboratory data.|||U/L||Standard Deviation|Mean
1373273|NCT01529268|Secondary|Fibrosis: Change in Stage|Change from baseline in fibrosis stage. The amount of fibrosis is based on central pathologist grading of liver biopsies: 0=none; 1a=mild, zone 3 perisinusoidal, 1b=moderate, zone 3, perisinusoidal, 1c=portal/periportal only, 2=zone 3 and periportal, any combination, 3=bridging, 4=cirrhosis. Fibrosis stages 1a, 1b, 1c recoded as 1, so the possible range of values for fibrosis stage was 0-4. Change in fibrosis stage has a possible range of -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
1373274|NCT01529268|Secondary|Fibrosis: Patients With Improvement|Improvement in fibrosis stage defined as any decrease in fibrosis stage comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
1373275|NCT01529268|Secondary|Portal Inflammation: Change in Score|Change from baseline in portal inflammation score. The amount of portal inflammation is based on central pathologist grading of liver biopsies: 0=none; 1=mild, 2=more than mild. Change in portal inflammation score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
1373276|NCT01529268|Secondary|Portal Inflammation: Patients With Improvement|Improvement in portal inflammation defined as any decrease in portal inflammation score comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
1373277|NCT01529268|Secondary|Hepatocellular Ballooning: Change in Score|Change from baseline in hepatocellular ballooning score. The amount of hepatocellular ballooning is based on central pathologist grading of liver biopsies: 0=none; 1=few ballooned hepatocytes, 2=many ballooned hepatocytes. Change in hepatocellular ballooning score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
1373278|NCT01529268|Secondary|Hepatocellular Ballooning: Patients With Improvement|Improvement in hepatocellular ballooning defined as any decrease in hepatocellular ballooning score comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
1373279|NCT01529268|Secondary|Lobular Inflammation: Change in Score|Change from baseline in lobular inflammation score. The amount of lobular inflammation is based on central pathologist grading of liver biopsies, and combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci: 0=none; 1=<2 under 20x magnification, 2=2-4 under 20x magnification, 3=>4 under 20x magnification. Change in lobular inflammation score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
1373280|NCT01529268|Secondary|Lobular Inflammation: Patients With Improvement|Improvement in lobular inflammation defined as any decrease in lobular inflammation grade comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
1373281|NCT01529268|Secondary|Steatosis: Change in Score|Change from baseline in steatosis score. Steatosis score is based on central pathologist grading of liver biopsies: 0=<5% steatosis; 1=5-33% steatosis, 2=34-66% steatosis, 3=>66% steatosis. Change in steatosis score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
1373282|NCT01529268|Secondary|Steatosis: Patients With Improvement|Improvement in steatosis defined as any decrease in steatosis grade comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
1373283|NCT01529268|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|Change from baseline in the NAFLD Activity Score (NAS), which is a composite score equal to the sum of the steatosis grade (0-3), lobular inflammation grade (0-3), and hepatocellular ballooning grade (0-2), from centralized pathologist scoring of liver biopsies. The overall scale of the NAS is 0-8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. Components of the NAS are scored as follows: Steatosis grade 0=<5% steatosis, 1=5-33% steatosis, 2=34-66% steatosis, 3=>66% steatosis. Lobular inflammation grade=amount of lobular inflammation (combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci): 0=0, 1=<2 under 20x magnification, 2=2-4 under 20x magnification, 3=>4 under 20x magnification. Hepatocellular ballooning 0=none, 1=mild, 2=more than mild.|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
1373284|NCT01529268|Primary|Improvement in Nonalcoholic Fatty Liver Disease (NAFLD)|Centrally scored and masked assessment of histologic improvement in Nonalcholic Fatty Liver Disease (NAFLD) between the baseline liver biopsy and follow-up biopsy after 52 weeks of treatment, where improvement is defined as: (1) decrease in the NAFLD Activity Score (NAS) of 2 or more and (2) no worsening of fibrosis.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
1373285|NCT01529203|Secondary|Related Adverse Event|Number of subjects reporting related adverse events|Month 6||||participants|||Number
1373286|NCT01529203|Secondary|Global Aesthetic Improvement From Baseline|"The scale responses are: -1 indicating worse, 0 indicating no change, 1 indicating improved, 2 indicating much improved and 3 indicating very much improved."|Week 3||||percentage of total subjects|||Number
1373363|NCT01528605|Secondary|Changes From Baseline in Microperimetry (MP) During the Intervention|Microperimetry (MP) was measured by the MP1 Microperimeter|at baseline, 24, 48 weeks and 2 years during the intervention||2015-12-31|12/2015||||
1373288|NCT01529112|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)|Blood samples were collected for lenvatinib PK analysis. Lenvatinib concentrations from sparse PK sampling were measured. The data is presented as mean nanograms per milliliter +/- Standard deviation of lenvatinib serum concentration.|Cycle 1/Day 1 (between 0.5 and 4 hours postdose and 6 and 10 hours postdose), Cycle 1/Day 15 (predose, between 0.5 and 4 hours postdose, and 6 and 10 hours postdose), and Day 1 of Cycles 2 though 4 (predose and between 2 and 12 hours postdose)|The analysis was performed using the pharmacokinetic (PK) analysis set defined as all subjects who received at least one dose of study drug and had evaluable PK data.|||nanograms per milliliter||Standard Deviation|Mean
1373289|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL|The EORTC module QLQ-LC13 symptom score was a self-reporting cancer-specific questionnaire composed of 13 questions incorporated into 1 multi-item scale designed to evaluate dyspnea and a series of single items assessing different types of pain, as well as, cough, hemoptysis, dysphagia, sore mouth, alopecia, and peripheral neuropathy. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with 100 representing the best possible function/QOL, and highest burden of symptoms for symptom domains and single items. The data is presented as percentage of participants with EORTC module QLQ-C13 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of participants|||Number
1373290|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)|The EORTC QLQ-C30 symptom score, a cancer specific self-reporting questionnaire was composed of 9-symptom scales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All of the multi-item scales and single-item measures ranged in score from 0 to 100. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with a higher scale score representing a higher response level/ high level of symptomatology / problems. The data is presented as percentage of participants with EORTC QLQ-C30 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of participants|||Number
1373291|NCT01529112|Secondary|Disease Control Rate (DCR)|The percentage of participants with CR, PR, or stable disease (SD) for greater than or equal to 12 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
1373292|NCT01529112|Secondary|Response Duration (RD)|Response duration, defined as the time from the date of the first assessment demonstrating a CR or PR to the date of the first assessment demonstrating progressive disease or death, whichever occurred first. This is an investigator assessed outcome, measured using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response duration was summarized by including only subjects with events. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using subjects with events.|||Weeks||95% Confidence Interval|Median
1373293|NCT01529112|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death from any cause.|From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||weeks||95% Confidence Interval|Median
1373294|NCT01529112|Secondary|Overall Response Rate (ORR)|ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
1373295|NCT01529112|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the randomization until the date of first documented disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or date of death from any cause (whichever occurred first), assessed based on investigator's assessment. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until date of first documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||weeks||95% Confidence Interval|Median
1373296|NCT01529112|Secondary|1-year Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 1 year and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 1 year|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
1373297|NCT01529112|Secondary|6-Month Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 6 months and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 6 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
1373298|NCT01529112|Secondary|Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the subject was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, treatment emergent adverse events (TEAEs) (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)|Safety was analyzed in Safety Analysis Set defined as all subjects enrolled and randomized to treatment in study, except for those who (i) dropped out prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.|||Participants|||Number
1373299|NCT01528969|Secondary|The Changes in the Counts of the 14 Other Bacterial Species|The bacterial species were measured from stimulated saliva at the beginning and after the intervention|5 weeks|||||||
1373300|NCT01528969|Primary|MS Counts of Stimulated Saliva|The MS counts were measured at the beginning and in the end of the 5 weeks intervention|5 weeks||||MS counts log CFU/ml||Standard Deviation|Mean
1373301|NCT01528891|Primary|Diastolic Blood Pressure (DBP)|"mmHg~Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis."|Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Diastolic blood pressure values were compared between groups at each time point and within groups over time.|||mmHg||Standard Deviation|Mean
1373302|NCT01528891|Primary|Systolic Blood Pressure (SBP)|"mmHg~Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis."|Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Systolic blood pressure values were compared between groups at each time point and within groups over time.|||mmHg||Standard Deviation|Mean
1373303|NCT01528891|Secondary|Incidence of Emergence Agitation (EA)|Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.|The highest PAED score for each patient within the first 30 minutes after waking up was recorded.|There were 2 patients in the Dexmedetomidine group and 9 patients in the placebo group who were excluded from analysis of emergence agitation. These patients were excluded because they received medications that were not a part of the anesthetic protocol and could affect their PAED score.|||percentage of patients with EA|||Number
1373304|NCT01528891|Primary|Heart Rate (HR)|beats per minute (bpm)|Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Heart rate values were compared between groups at each time point and within groups over time.|||bpm||Standard Deviation|Mean
1373305|NCT01528878|Secondary|Overall Survival of Patients With Liver Cancer or Metastases to the Liver|Overall survival is defined as percentage of patients remaining alive from start of study treatment to 1 year.|1 year||||percentage of participants|||Number
1373306|NCT01528878|Secondary|Percentage of Local Response to Doses of Radiation in Patients With Liver Cancer or Metastases to the Liver|Complete response (CR) is defined as disappearance of the target lesion, partial response (PR) as regression of measureable disease, progressive disease (PD) as increase by >= 50% in product of the two perpendicular diameters of an irradiated lesion, and stable disease (SD) as all others not meeting criteria for CR, PR, or PD.|6 months||||percentage of participants|||Number
1373364|NCT01528605|Secondary|Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks||at baseline and 48 weeks during the intervention||2015-12-31|12/2015||||
1373307|NCT01528878|Secondary|Local Tumor Control to Doses of Radiation in Patients With Liver Cancer or Metastases to the Liver|1 year local control defined as percentage of patients with freedom from local progression at a median follow-up time of 12.7 months. Progressive disease is defined as increase by >= 50% of product of the two perpendicular diameters of an irradiated lesion.|12.7 months||||percentage of participants|||Number
1373308|NCT01528878|Primary|Tolerability of Stereotactic Body Radiotherapy (SBRT) Based on Number of Cumulative Acute Toxicities Occurring Within 90 Days of Treatment and Related to SBRT.|To determine a tolerable dose, cumulative acute toxicity was collected (defined as toxicity occurring within 90 days of treatment initiation). Adverse events were graded by the Common Terminology Criteria for Adverse Events version 3.0. Tolerability was based on hepatic toxicity. A grading (severity) scale is provided for each adverse event (AE) term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|90 days||||Participants|||Count of Participants
1373309|NCT01528787|Primary|Intraocular Pressure (IOP)|"The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8.~Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4."|Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.|Modified intent to treat (mITT) population (85 patients receiving investigational treatment). Participants who did not complete the study did not contribute data at later time points.|||mmHg||Standard Deviation|Mean
1373310|NCT01528735|Secondary|Predose Measured Concentration of RBV|Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373311|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of RBV|"Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
1373312|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,57) of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373313|NCT01528735|Secondary|AUC Accumulation Ratio of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373314|NCT01528735|Secondary|Predose Measured Concentration of CD 6168-AG|Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373315|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168-AG|"Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide.~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
1373316|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373365|NCT01528605|Secondary|Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer|Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks|at baseline, 24, 48 weeks and 2 years during the intervention||2015-12-31|12/2015||||
1373317|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373318|NCT01528735|Secondary|Predose Measured Concentration of CD 6168|Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373319|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168|"Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
1373320|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373321|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373322|NCT01528735|Secondary|Predose Measured Concentration of BI 208333|Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373323|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of BI 208333|"Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
1373324|NCT01528735|Secondary|AUC Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373325|NCT01528735|Secondary|Cmax Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373326|NCT01528735|Secondary|Predose Measured Concentration of Faldaprevir|Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373366|NCT01528605|Secondary|Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention||at baseline, 24, 48 weeks and 2 years during the intervention||2015-12-31|12/2015||||
1373327|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Faldaprevir|Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1373328|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Faldaprevir|"Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
1373329|NCT01528735|Secondary|AUC Accumulation Ratio of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373330|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373331|NCT01528735|Secondary|Predose Measured Concentration of Deleobuvir|Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373332|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Deleobuvir|Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||Litres per hour||Geometric Coefficient of Variation|Geometric Mean
1373333|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Deleobuvir|Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||hours||Geometric Coefficient of Variation|Geometric Mean
1373334|NCT01528735|Secondary|AUC Accumulation Ratio of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373335|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1373336|NCT01528735|Secondary|Area Under the Curve (AUC) of RBV|Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1373378|NCT01528332|Secondary|Changes From Baseline in Skin Condition|Skin condition (erythema and hyperpigmentation as measured with the MX-18) and appearance (recorded with Polaroid photos) will be assessed once each at baseline and follow up, and before and after each treatment. The changes from baseline will be analysed using descriptive statistics and the two treatment arms compared.|Baseline (days -7 to -1) to Follow up (up to day +42)|||||||
1373337|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of RBV|Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1373338|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of RBV|Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373339|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168-AG|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373340|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG|Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1373341|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168-AG|Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373342|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373343|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168|Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1373344|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168|Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373345|NCT01528735|Secondary|Area Under the Curve (AUC) of BI 208333|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373346|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333|Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1373347|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of BI 208333|Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373379|NCT01528332|Secondary|Vital Sign Parameters|Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups|Baseline (days -7 to -1) to Follow up (up to day +42)|||||||
1385425|NCT01402128|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/l||Standard Deviation|Mean
1373348|NCT01528735|Secondary|Area Under the Curve (AUC) of Faldaprevir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1373349|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir|Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1373350|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Faldaprevir|Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373351|NCT01528735|Secondary|Area Under the Curve (AUC) of Deleobuvir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373352|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir|Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1373353|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Deleobuvir|Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373354|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 8|Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8.|8 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load|||percentage of participants|||Number
1373355|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 4|Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4.|4 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load|||percentage of participants|||Number
1373356|NCT01528735|Primary|Number of Patients With Drug-related Adverse Events|Number of patients with investigator defined drug-related Adverse Events|From first dose of study medication until 30 days after last dose of study medication, up to 199 days|Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1373357|NCT01528709|Secondary|Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography|Vein graft stenosis 1 year after CABG based on CT coronary angiography|Within 1 year after CABG||||percentage of vein grafts with stenosis|||Number
1373358|NCT01528709|Primary|Saphenous Vein Graft Patency|Vein graft patency will be assessed in a blinded fashion by CT coronary angiography 1 year after CABG|1 year after CABG||||percentage of vein grafts occluded|||Number
1373359|NCT01528696|Secondary|Patient Report of Pain Severity and Control|Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain|6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.||||||
1373360|NCT01528696|Secondary|Febrile Morbidity|Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery.|2 days, 6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.||||||
1373361|NCT01528696|Primary|Number of Patients Who Experience One or More Wound Complications|A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report.|6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.||||||
1373362|NCT01528605|Secondary|Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention||at baseline, 24, 48 weeks and 2 years||2015-12-31|12/2015||||
1373367|NCT01528605|Secondary|Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention|best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 24 weeks, 48 weeks, 2 years during the intervention||||letters||Standard Deviation|Mean
1373368|NCT01528605|Secondary|Changes of Serum Xanthophylls Concentrations During the Intervention|Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 4, 12, 24 and 48 weeks during the intervention||||μmol/L||Standard Deviation|Mean
1373369|NCT01528605|Primary|Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years|"Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.~4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer."|at baseline and 24 weeks, 48 weeks, 2 years during the intervention||||density units||Standard Deviation|Mean
1373370|NCT01528592|Primary|Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.|Correlation coefficient between UPDRS III score and independent components analysis network strength in left parietal cortex. UPDRS III is the Unified Parkinson's Disease Rating Scale composite motor score.|1 hour||||unitless|||Number
1373371|NCT01528345|Secondary|Time to Worsening of ECOG Performance Status|Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.)|Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)|This outcome measure was not analyzed as the study was terminated before time to worsening ECOG performance could be analyzed.||||||
1373372|NCT01528345|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events.~The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details."|Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months)|Safety Set: Consisted of all patients who received at least one dose of any compound of the study treatment (dovitinib +fulvestrant or placebo+fulvestrant). Patients were analyzed according to the actual study treatment received. Actual treatment received was defined as the treatment the patient received at the first day of study medication.|||Participants|||Number
1373373|NCT01528345|Secondary|Overall Survival (OS) Using Kaplan- Meier Method|OS was defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.|From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
1373374|NCT01528345|Secondary|Duration of Response (DOR)|DOR was defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment.|From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months|This outcome measure was not analyzed as the study was terminated before duration of response could be analyzed.||||||
1373375|NCT01528345|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.|||Percentage of participants||95% Confidence Interval|Number
1373376|NCT01528345|Primary|Progression Free Survival (PFS) Based on Local Investigator Assessment|PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they wereassigned at randomization.|||Months||95% Confidence Interval|Median
1373377|NCT01528332|Secondary|Average Visual Analog Scale Pain Relief Over 5 Treatments|The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief|5 treatments (days +1 to +14)|||||||
1373385|NCT01528332|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5|The RMDQ is a 24 list of yes/no questions about the effects of back pain on the participants daily activities. Each positive answer is a point; maximum total score = 24.|Baseline (days -7 to +1) to Treatment 5 (day +14)|||||||
1373386|NCT01528332|Primary|Change From Baseline (Mean of Three Measurements at Screening, Prior to Treatment Visit 1 and Treatment Visit 1 Pretreatment) in the Average Visual Analog Scale (VAS) Pain Intensity Over the 5 Treatment Days|Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable|Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)||||cm||Standard Error|Mean
1373387|NCT01528319|Secondary|Adverse Event Evaluation|To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery|Between the time of obtainment of consent and 24 weeks after surgery||||participants|||Number
1373388|NCT01528319|Secondary|Number of Participants With Abnormal Changes in One or More Laboratory Tests|To evaluate changes over time in each laboratory test item from before surgery to 12 and 24 weeks after surgery regarding the presence or absence of abnormal changes, causal relationship with this product and causes for development|12 weeks and 24 weeks after surgery||||participants|||Number
1373389|NCT01528319|Secondary|Clinical Function Evaluation|"To evaluate the JSS-SIS score and Rowe score at 24 weeks after surgery~JSS-SIS Score (subscales are summed, higher values represent a better outcome):~Pain (0 to 20)~Function (0 to 20)~Range of Motion (0 to 20)~Evaluation of X-ray findings (0 to 10)~Stability (0 to 30)~Rowe Score (subscales are summed, higher values represent a better outcome):~Stability (0 to 50)~Motion (0 to 20)~Function (0 to 30)"|24 weeks||||units on a scale||Standard Deviation|Mean
1373390|NCT01528319|Secondary|Procedure Success|The rate of successful cases when procedure success was defined as “The anchors can be inserted into the burr holes without breakage and the glenohumeral ligament labral complex can be sutured without tear of the sutures”|12 weeks||||participants|||Number
1373391|NCT01528319|Primary|Clinical Function Evaluation|"To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery~JSS-SIS Score (subscales are summed, higher values represent a better outcome):~Pain (0 to 20)~Function (0 to 20)~Range of Motion (0 to 20)~Evaluation of X-ray findings (0 to 10)~Stability (0 to 30)~Rowe Score (subscales are summed, higher values represent a better outcome):~Stability (0 to 50)~Motion (0 to 20)~Function (0 to 30)"|12 weeks||||units on a scale||Standard Deviation|Mean
1373392|NCT01528319|Primary|Surgery Success|The rate of successful cases when surgery success is defined as “Procedure success is confirmed, the anchors are confirmed to be in the burr holes by the MRI examination, the glenohumeral ligament labral complex is maintained at the anterior edge of the glenoid cavity at 12 weeks after surgery, and there is no need of retreatment”|12 weeks after surgery||||participants|||Number
1373393|NCT01528293|Secondary|Degree of Take|Degree of split thickness skin graft taken or bioengineered alternative tissue induced wound shrinkage after 6 weeks of ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 Weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
1373394|NCT01528293|Secondary|Quality of Life|Quality of life between ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
1373395|NCT01528293|Secondary|Compare the Time to Wound Bed Preparation, Quality of Life, Degree of Split Thickness Skin Graft/Bio-engineered Alternative Tissue Take|-Compare the time to wound bed preparation between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
1373396|NCT01528293|Primary|Compare Wound Healing|Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
1373397|NCT01528215|Primary|Marginal Bone Level|Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value denotes gain of bone. Negative value denotes loss of bone.|12 months after implant loading||||Millimeter|Implants|Standard Deviation|Mean
1373398|NCT01528150|Primary|Freedom From RA and RV Lead-related Complications|Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.|up to 12 months post-implant|A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.|||percentage of participants||97.5% Confidence Interval|Number
1373399|NCT01528124|Secondary|Number of Participants Developing Anti-LY3025876 Antibodies|Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876.|Day 28 post-dose|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1373400|NCT01528124|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876||Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose|PK Population: all participants who received at least 1 dose of study drug and had evaluable Cmax PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1373401|NCT01528124|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876|Area under the concentration-versus-time curve from time zero to infinity [AUC(0-∞)] of LY3025876.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) PK data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1373402|NCT01528124|Primary|Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events|Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.|Baseline up to 28 days post-dose|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1373403|NCT01527942|Secondary|Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.|The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.|24 hours after baseline|Study was terminated - data were determined to be unusable by IRB due to consent issues.||||||
1373404|NCT01527942|Secondary|Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours|The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.||||||
1373405|NCT01527942|Primary|Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours|The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.||||||
1373406|NCT01527513|Secondary|Change From Baseline in Seizure Frequency During the One-year Open-Label (OL)|Overall Change from Baseline in Seizure Frequency per week for the One-Year Open-Label Period|Weeks 1 to ≥ 41 weeks|Modified Efficacy Intent-to-Treat (ITT) population– all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||Seizure per week||Standard Error|Mean
1373407|NCT01527513|Secondary|Change From Baseline in Standardized Seizure Frequency - Part I||Baseline; Titration Period (4 Weeks: V2-V3-V4)|Modified Efficacy ITT population – all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||Seizures per week||Standard Deviation|Mean
1373408|NCT01527513|Primary|Change From Baseline in Power of Attention Score to the End of the Double Blind (DB) Period|Power of Attention was defined as the sum of the reaction time measures from the attentional tasks (simple [dominant hand only] reaction time, choice reaction time and digit vigilance speed) in order to assess information processing speed and attention/psychomotor speed.Change from baseline to the end of the double-blind period in Power of Attention will be compared between the treatment groups using an ANCOVA. Non-inferiority of ESL vs Placebo will be assessed by comparing the 95% CI’s upper bound of the difference of Least Squares Mean (LSmeans) between treatment groups (ESL-placebo) with 121 ms. If the upper bound is greater than 121 ms then the null hypothesis that the change from baseline in the Power of Attention score in ESL group is at least 121 ms inferior than the placebo group will be rejected. Single Values were calculated the average of post treatment visits (visits 5 and 7or EDV) minus average of baseline visits (visits 1 and 2)|Visit 1 (-4 weeks for training), Visit 2 (Day 1), Visit 5 (6 weeks), Visit 7 (12 weeks) or at early discontinuation visit (EDV)|The primary analysis was based on the Cognitive Per-protocol (PP) population – all patients in the Modified Cognitive Intent-to-Treat (ITT) population who completed the 8-week maintenance period and were not Important Protocol Deviations (IPDs) with respect to the primary cognitive endpoint.|||Milli seconds (ms)||Standard Error|Mean
1373409|NCT01527500|Secondary|Part B: Cmax_D - Summary Statistic for PK Parameters|Cmax_D=ng/mL/mg|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||ng/mL/mg||Standard Deviation|Mean
1373410|NCT01527500|Secondary|Part B: Cmax - Summary Statistic for PK Parameters|Summary statistic for Part B of total LFG316 concentrations (pharmacokinetic analysis set) Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||ng/mL||Standard Deviation|Mean
1373411|NCT01527500|Secondary|Tmax (hr)|"PART B: Tmax (Time of Maximum concentration observed)~This is the highest concentration of drug in the blood that is measured after a dose. Cmax usually happens within a few hours after the dose is taken. The time that Cmax happens is referred to as Tmax. For some antiretroviral drugs, a high Cmax is thought to increase the risk of side effects from the drug."|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||hours||Full Range|Median
1373412|NCT01527500|Primary|Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD).|This primary outcome (for Part B) is reported under the Adverse Events section.|Day 1 to Day 85||||number of patients|||Number
1373413|NCT01527500|Secondary|Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters|"Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)~n=number of participants, h=scheduled sampling time"|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||hr*ng/mL||Standard Deviation|Mean
1373414|NCT01527500|Primary|Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence|Number is the Estimated Difference (95% CI) in lesion size.|The primary objective was from Day 1 to Day 337, however data was captured to Day 505 as exploratory objective|PD Set which included patients who had at least one dose of study drug and had evaluable PD Data.|||mm^2||95% Confidence Interval|Mean
1373415|NCT01527500|Secondary|Part A: Concentrations of Total C5 in Blood During the Course of the Study|Summary statistic of total C5 concentrations n=number of participants, h=scheduled sampling time|Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)|PD Analysis includes patients who received at least one dose of study drug with evaluable PD data.|||ng/mL||Standard Deviation|Mean
1373416|NCT01527500|Secondary|Part A: Concentrations of Total LFG316 in Blood During the Course of the Study|"Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)~n=number of participants, h=hours after the last administered dose e.g.; 0.0 means just before dosing. If the mean concentration is 0.00, that means there is no drug in the bloodstream"|Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||ng/mL||Standard Deviation|Mean
1373417|NCT01527500|Secondary|Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW|Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: FELLOW|Baseline Day 1, Day 169, Day 337 to Day 505|PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data.|||ETDRS Letters||Standard Deviation|Mean
1373418|NCT01527500|Secondary|Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham|Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: STUDY|Baseline Day 1, Day 169, Day 337 to Day 505|PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data.|||ETDRS letters||Standard Deviation|Mean
1373419|NCT01527500|Secondary|Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence|Mean change in GA lesion growth from baseline to Day 169 and Day 505.|Day 1 to Day 169 and Day 505 (starting from the day of first intravitreal injection until Day 505)|PD Set which included patients who had at least one dose of study drug and had evaluable PD Data.|||mm^2||Standard Deviation|Mean
1373420|NCT01527500|Primary|Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505|Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.|Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505)|Pharmacodynamic analysis set (PD) which includes all patients with at least one dose of study drug and evaluable PD data.|||mm^2||Standard Deviation|Mean
1373421|NCT01527487|Secondary|Disease-Free Survival (DFS) at 2 Years|Defined as the percent probability that participants had not experienced disease recurrence or died from any cause at 2 years post-surgery, analyzed by Kaplan-Meier methodology.|24 months|Includes all patients that completed surgery.|||percent probability of survival||95% Confidence Interval|Number
1373422|NCT01527487|Secondary|Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy|Defined as the number of patients with a best response of clinical complete or partial response (cCR or cPR) divided by the number of patients qualified for tumor response analysis per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI or CT. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD;|43 months|All patients evaluated/evaluable per RECIST v1.1|||percentage of participants|||Number
1373423|NCT01527487|Secondary|The Number of Adverse Events as a Measure of Safety and Tolerability.|Treatment-Related Adverse Events occurring in >= 15% of treated patients|43 months||||participants|||Number
1373424|NCT01527487|Primary|Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery|One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist.|18 weeks|Patients who completed 6 cycles and proceeded to surgery.|||percentage of surgical patients|||Number
1373425|NCT01527370|Primary|Number of Participants With Serious Adverse Events|"A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to 42 days postvaccination|This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.|||Participants|||Number
1373426|NCT01527370|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination|GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.|||Ratio||95% Confidence Interval|Geometric Mean
1373427|NCT01527370|Primary|The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination|Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1373428|NCT01527162|Secondary|Assessment of Life Habits for Children (LIFE-H)|Participation in habits of daily life will be by parental report of the Life Habits questionnaire(Life-H for children) by the weighted total score on a scale of 0 to 9, with a higher score representing more participation in habits of daily life.|previous 7 day reference||||units on a scale||Standard Deviation|Mean
1373429|NCT01527162|Secondary|Physical Activity Scale for Kids - Performance Version (ASKp)|Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey- total score. Scale ranges from 0 to 100 with higher scores representing more physical activity. A score of 100 on this criterion referenced evalutive measure is consistent with physical activity like that of a typically developing 5 year old.|previous 7 day reference||||units on a scale||Standard Deviation|Mean
1373431|NCT01527110|Secondary|Mean Change From Baseline in Quantitative Viral Load Measured by Viral Culture From Nasopharyngeal Swabs Over Period|Quantitative viral culture as 50 % tissue culture infectious dose (TCID50) defined as median tissue culture infective dose is that amount of a pathogenic agent that produces pathological change in 50% of cell cultures inoculated. It was carried out on nasopharyngeal swabs collected on Day 1 up to Day 33 (last day) depending on the extend of continuation of treatment and duration of hospitalization. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Any undetectable viral load values were calculated as x.x Log10 TCID50: x.x Log10 (1.5 or 7.5 was the lower or upper limit of quantification in TCID50). Data is presented for Day 3, Day 5 and last day.|Baseline (Day 1) up to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||LOG TCID50/mL||Standard Deviation|Mean
1373432|NCT01527110|Secondary|Mean Change From Baseline in Quantitative Viral Load Measured by RT-PCR From Nasopharyngeal Swabs Positive at Baseline Over Period|Quantitative RT-PCR was carried out on nasopharyngeal swabs collected on Day 1 up to Day 33 (last day) depending on the extend of continuation of treatment and duration of hospitalization. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Analysis was done for participants with positive Influenza A RNA and Influenza B RNA. Data is presented for Day 3, Day 5 and last day.|Baseline (Day 1) up to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||Logarithmic base 10 (log 10) copies/mL||Standard Deviation|Mean
1373433|NCT01527110|Secondary|Median Time to no Detectable Viral RNA by Quantitative RT-PCR and Viral Culture From Nasopharyngeal Samples Over Period|Quantitative RT-PCR and quantitative viral culture was carried out on nasopharyngeal swabs collected on Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
1373434|NCT01527110|Secondary|Percentage of Participants With Undetectable Viral RNA and Absence of Cultivable Virus in Lower Respiratory Samples Over Period|Quantitative RT-PCR and quantitative viral culture was carried out on lower respiratory samples (endotracheal aspirates) collected on Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization. Endotracheal aspirates were used in participants who were intubated. Undetectable RNA concentrations were below the level of quantification.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||% of participants|||Number
1373435|NCT01527110|Secondary|Percentage of Participants With Undetectable Viral RNA and Absence Cultivable Virus From Samples Obtained From Nasopharyngeal Samples Over Period|Quantitative RT-PCR and quantitative viral culture was carried out on nasopharyngeal swabs collected from Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization of the participants. Undetectable RNA concentrations were below the level of quantification.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||% of participants|||Number
1373436|NCT01527110|Secondary|Median Time to Virologic Improvement Over Period|Virologic improvement was defined as a 2 log drop in viral load or sustained undetectable viral ribonucleic acid (RNA), on 2 successive occasions as measured by quantitative reverse transcriptase – polymerase chain reaction (RT-PCR) from nasopharyngeal samples. Assessment was done from Baseline (Day 1) up to Day 33 (follow-up).|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||Days||Full Range|Median
1373437|NCT01527110|Secondary|Number of Participants With Complications of Influenza and Associated Use of Antibiotics Over Period|"The details of complications of influenza like bacterial pneumonia, pneumothorax, pleural effusion, acute respiratory distress syndrome (ARDS), myositis, encephalitis, myocarditis and associated antibiotic use were assessed from Baseline (Day 1) to Day 33 (follow-up). Participants with complications of influenza, with associated use of antibiotics as  associated antibiotic use yes and without associated use of antibiotics as associated antibiotic use no were categorized."|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Participants|||Count of Participants
1373438|NCT01527110|Secondary|Median Duration of Clinical Symptoms of Influenza Over Period|Influenza symptoms were assessed at Baseline (pre-dose) and throughout the study period as presence of the following symptoms were recorded: nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea and vomiting. The investigator assessed and recorded influenza symptoms based on interview with the participants. In cases where participants were not able to communicate their symptoms, in participants ventilated and/or sedated, the investigator recorded those signs/symptoms as ‘unable to assess’.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
1373439|NCT01527110|Secondary|Number of Participants of Clinical Symptoms of Influenza Over Period|Influenza symptoms were assessed at Baseline (pre-dose): the presence of the following symptoms were recorded: nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea and vomiting. The investigator assessed and recorded influenza symptoms based on interview with the participants. In cases where participants were not able to communicate their symptoms, in participants ventilated and/or sedated, the investigator recorded those signs/symptoms as ‘unable to assess'.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Participants|||Count of Participants
1373440|NCT01527110|Secondary|Number of Participants With or Without Treatment Emergent Resistance or Suspected Treatment Emergent Resistance to Zanamivir Over Period|A total of 30 neuraminidase gene sequences (23 influenza A/H3N2, 5 influenza B and 2 negative) from 21 participants were obtained from 76 samples. There were no resistance associated neuraminidase mutations or mutations in the neuraminidase active site identified in viruses isolated during this study. Therefore the frequency of resistance emergence to zanamivir could not be determined.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants with Influenza A/H3N2 (17) and Influenzavirus B (3) were used for analysis.|||Participants|||Count of Participants
1373744|NCT01524133|Secondary|Patient Health Questionnaire-15|PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe|24 weeks|All Randomized patients who received treatment and had the measure|||Scores on a scale||Standard Deviation|Mean
1373441|NCT01527110|Secondary|Mean 50% Inhibitory Concentration (IC50) for Phenotypes of Influenza for the Measure of Viral Susceptibility to Zanamivir at All Visits|IC50 value is defined as the concentration of zanamivir required to achieve half maximal inhibition of the influenza viral enzyme neuraminidase of influenza A and B to prevent the release and spread of influenza virus in the respiratory tract. Susceptibility analyses were performed on nasopharyngeal swabs collected on Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization. Endotracheal aspirates were used in participants who were intubated. Data is categorized for participants with influenza A/H3N2 and influenza B.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||Nanomole per liter (nmol/L)||Standard Deviation|Mean
1373442|NCT01527110|Secondary|Median Duration of Hospital Stay for the Participants Over Period|The duration of hospital stay was assessed from the first day of dosing (Day 1) up to Day 33 (follow-up). The duration was calculated as duration in hospital = date/time of discharge - date/time of 1st day of dosing.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||hour||Full Range|Median
1373443|NCT01527110|Secondary|Median Duration of Intensive Care Unit (ICU) Stay for the Participants Over Period|The duration of ICU stay was assessed from the first day of dosing (Day 1) up to Day 33 (follow-up). Duration in ICU was captured from the eCRF. If the duration in ICU was missing, then the data was set to 0.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Days||Full Range|Median
1373444|NCT01527110|Secondary|Median Duration of Use of Invasive and Non-invasive Ventilatory Support and Oxygen Supplementation Over Period|The non-invasive ventilator support includes modalities of machine-assisted: CPAP and BiPAP. The invasive ventilator support included modalities of machine-assisted: ECMO and endotracheal mechanical ventilation. Participants with use of modality of invasive, non-invasive ventilatory support and oxygen supplementation was assessed from Baseline (Day 1) to Day 33 (follow-up).|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants with use of modality of invasive and non-invasive ventilatory support (3) and oxygen supplementation (11) were analysed.|||hour||Full Range|Median
1373445|NCT01527110|Secondary|Number of Participants With and Without Use of Modality of Invasive, Non-invasive Ventilatory Support and Oxygen Supplementation Over Period|The non-invasive ventilator support includes modalities of machine-assisted: continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP). The invasive ventilator support included modalities of machine-assisted: extra corporeal membrane oxygenation (ECMO) and endotracheal mechanical ventilation. Participants with and without use of modality of invasive, non-invasive ventilatory support and oxygen supplementation was assessed from Baseline (Day 1) to Day 33 (follow-up).|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Participants|||Count of Participants
1373446|NCT01527110|Secondary|Median Time to Return to Pre-morbid Level of Activity Over Period|Pre-morbid functional status was defined as the best functional status in the 4 weeks prior to enrolment and status at Baseline (Day 1). The participants were assessed on a 3-point scale by activity level (bed rest, limited ambulation or unrestricted) recorded in thee electronic case report form (eCRF). For participants who were unable to communicate their pre-morbid functional status, the information was requested from another close member of the household or close family member.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||hour||Full Range|Median
1373447|NCT01527110|Secondary|Median Time to Clinical Response Over Period|Clinical response was defined as resolution of at least 4 of the 5 vital signs within the respective resolution criteria of temperature <= 36.6 degree C–axilla or <= 37.2 degree C–oral or <= 37.7 degree C–rectal/ tympanic, without the use of antipyretics within 8 hour; OS of >= 95%; respiratory status of return to pre-morbid oxygen requirement (participants with chronic oxygen use) or need for supplemental oxygen (administered by any modality) to no need for supplemental oxygen or RR <= 24 breaths/min without supplemental oxygen; HR <=100 beats/min; SBP of >= 90 mmHg without inotropic support within 8 h, maintained for at least 24 hour, or hospital discharge, which ever occurred first. Participants discharged from hospital due to clinical improvement/resolution were considered to have met the clinical response endpoint at the time of hospital discharge and were not required to have documented resolution of at least 4 response criteria i.e. achieved success at the time of discharge.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||hour||Full Range|Median
1373448|NCT01527110|Secondary|Median Time to Absence of Fever, Improved Respiratory Status, Improved OS, Improved HR and Improved SBP Over Period|Absence of fever, improved respiratory status, OS, HR and SBP was defined according to clinical response criteria as: temperature, <= 36.6 degree C–axilla or <= 37.2 degree C–oral or <= 37.7 degree C–rectal and tympanic, without the use of antipyretics within 8 hour; OS of >= 95%; respiratory status of return to pre-morbid oxygen requirement (participants with chronic oxygen use) or need for supplemental oxygen (administered by any modality) to no need for supplemental oxygen or RR <=24 breaths/min without supplemental oxygen; HR <=100 beats/min; SBP of >=90 mmHg without inotropic support within 8 hour. For OS, participants with a history of chronic hypoxia (without supplemental oxygen) satisfied normalization criteria for OS if the value without supplemental oxygen was <=2% from participants historical OS and waiver for participants with a history of chronic supplemental oxygen requirement with baseline OS <95% with supplemental oxygen, recorded within 12 months prior to enrolment.|Baseline (Day 1) to Day 33 (follow-up)|Intent-to-Treat Exposed (ITT-E) Population comprised of all participants who receive at least one dose of IV zanamivir. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
1373449|NCT01527110|Primary|Percentage of Participants With Abnormal Clinically Significant ECG Findings Over Period|12-lead ECG assessments were obtained at Baseline (Day 1) and Day 4 of the treatment period. On Baseline (Day 1), 2 baseline ECGs were obtained. On Day 4, 2 ECGs were obtained, 1 ECG just prior to study drug infusion and 1 ECG at the end of infusion. Overall ECG findings were summarized at Day 1 (ECG 1 and ECG 2) and Day 4 (pre-dose and 30-min post dose).|Baseline ( pre-dose Day 1) and Day 4|Safety Population. Only those participants available at the specified time points were analyzed.|||% of participants|||Number
1373749|NCT01523899|Primary|Number of Participants With Antibiotic Usage at the Time of the ED Visit|Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit|Baseline||||Participants|||Count of Participants
1373450|NCT01527110|Primary|Number of Participants With Abnormal Clinically Significant Electrocardiograph (ECG) Findings Over Period|12-lead ECG assessments were obtained at Baseline (Day 1) and Day 4 of the treatment period. On Baseline (Day 1), 2 baseline ECGs were obtained prior to study drug infusion. On Day 4, 2 ECGs were obtained, 1 ECG just prior to study drug infusion and 1 ECG at the end of infusion. Overall ECG findings were summarized with regard to visits at Day 1 (pre-dose [ECG 1 and ECG 2]) and Day 4 (pre-dose and 30-min post dose).|Baseline (Day 1, pre-dose) and Day 4|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1373451|NCT01527110|Primary|Mean Temperature of Participants Over Period|Vital signs of temperature was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Maximum value in a day is reported, where a‘day’ was defined as a 24 h period (Treatment Day).|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Degrees celcius (C)||Standard Deviation|Mean
1373452|NCT01527110|Primary|Mean Respiratory Rate (RR) of Participants Over Period|Vital signs of RR was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Maximum value in a day is reported, where a ‘day’ was defined as a 24 h period (Treatment Day).|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths/min||Standard Deviation|Mean
1373453|NCT01527110|Primary|Mean Oxygen Saturation (OS) of Participants Over Period|Vital signs of OS was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Minimum value in a day is reported, where a ‘day’ is defined as a 24 h period (Treatment Day).|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Percent oxygen saturation||Standard Deviation|Mean
1373454|NCT01527110|Primary|Mean Systolic and Diastolic Blood Pressure (SBP and DBP) of Participants Over Period|Vital signs of SBP and DBP were assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Minimum value in a day for SBP is reported where a ‘day’ is defined as a 24 h period (Treatment Day). DBP is measured at the same time as minimum SBP.|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1373455|NCT01527110|Primary|Mean Heart Rate (HR) of Participants Over Period|Vital sign of HR was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Maximum value in a day is reported where a ‘day’ is defined as a 24 h period (Treatment Day).|Baeline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats/min||Standard Deviation|Mean
1373456|NCT01527110|Primary|Number of Participants of Treatment Emergent Toxicities in Clinical Chemistry and Hematology Over Period|The normal reference ranges for clinical chemistry and hematology parameters were ALT 5 to 45 IU/L, ALP 100 to 325 IU/L, creatine kinase 60 to 270 IU/L, AST 10 to 40 IU/L, creatinine 41.548 to 69.836 µmol/L, direct bilirubin 0 to 5.13 µmol/L, total bilirubin 3.42 to 20.52 µmol/L, calcium 2.0958 to 2.5948 mmol/L, CO2/ bicarbonate 19.2 to 27.1 mmol/L, chloride 98 to 108 mmol/L, magnesium 0.7809 to 1.0275 mmol/L, potassium 3.5 to 5 mmol/L, sodium 137 to 147 mmol/L, urea/ BUN 2.856 to 8.211 mmol/L, basophils 0 to 2%, eosinophils 0 to 8%, lymphocytes 18 to 49%, monocytes 2 to 10%, total neutrophils 40 to 75%, platelet count 140 to 340 GI/L, WBC count 3.3 to 9 GI/L, hemoglobin 135 to 175 g/L and haematocrit 0.397 to 0.524 ratio. Participants with treatment emergent toxicities for grade 3 (severe) and grade 4 (potentially life threatening) were assessed at Day 1, Day 3 and Day 5. Classification of the toxicities as potentially drug-related was done based on the investigator's judgment.|Day 1, Day 3 and Day 5|Safety Population|||Participants|||Count of Participants
1373457|NCT01527110|Primary|Number of Participants With Toxicity Shifts From Baseline in Hematology Parameters Over Period|The reference ranges for hematology parameters were basophils 0 to 2%, eosinophils 0 to 8%, lymphocytes 18 to 49%, monocytes 2 to 10%, total neutrophils 40 to 75%, platelet count 140 to 340 GI/L, WBC count 3.3 to 9 GI/L, hemoglobin 135 to 175 g/L and haematocrit 0.397 to 0.524 ratio. The baseline assessments were referred to assessments at Day 1. Number of participants with shifts between NR high, within NR and NR low values in hematology parameters from baseline (Day 1) at Day 3 and Day 5 is reported.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Participants|||Count of Participants
1373458|NCT01527110|Primary|Number of Participants With Toxicity Shifts From Baseline in Clinical Chemistry Over Period|The reference ranges for clinical chemistry parameters were ALT 5 to 45 IU/L, ALP 100 to 325 IU/L, creatine kinase 60 to 270 IU/L, AST 10 to 40 IU/L, creatinine 41.548 to 69.836 µmol/L, direct bilirubin 0 to 5.13 µmol/L, total bilirubin 3.42 to 20.52 µmol/L, calcium 2.0958 to 2.5948 mmol/L, CO2/ bicarbonate 19.2 to 27.1 mmol/L, chloride 98 to 108 mmol/L, magnesium 0.7809 to 1.0275 mmol/L, potassium 3.5 to 5 mmol/L, sodium 137 to 147 mmol/L and urea/ BUN 2.856 to 8.211 mmol/L. The baseline assessments were referred to assessments at Day 1. Number of participants with shifts between normal range (NR) high, within NR and NR low values in hematology parameters from baseline (Day 1) at Day 3 and Day 5 is reported.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Participants|||Count of Participants
1373459|NCT01527110|Primary|Mean Change Baseline in Hematocrit at the Indicated Time Points|Hematocrit was measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Ratio||Standard Deviation|Mean
1373460|NCT01527110|Primary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points|Hemoglobin was measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||g/L||Standard Deviation|Mean
1373461|NCT01527110|Primary|Mean Change From Baseline in Counts of WBC and Platelets at the Indicated Time Points|WBC and platelet counts were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. Only those participants available at the specified time points were analyzed.|||GI/L||Standard Deviation|Mean
1373462|NCT01527110|Primary|Mean Change From Baseline in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils at the Indicated Time Points|Percentages of basophils, eosinophils, lymphocytes, monocytes and total neutrophils were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline, Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Percent of blood cells||Standard Deviation|Mean
1373463|NCT01527110|Primary|Mean Change From Baseline in Sodium, Calcium, Potassium, Chloride, Magnesium, Carbon Dioxide Content/Bicarbonate and Urea/BUN at the Indicated Time Points|Calcium, potassium, chloride, magnesium, carbon dioxide content/bicarbonate, sodium and urea/BUN were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||mmol/L||Standard Deviation|Mean
1373464|NCT01527110|Primary|Mean Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at the Indicated Time Points|Creatinine, direct bilirubin and total bilirubin were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||µmol/L||Standard Deviation|Mean
1373465|NCT01527110|Primary|Mean Change From Baseline in ALT, ALP, Creatine Kinase and AST at the Indicated Time Points|ALT, ALP, creatine kinase and AST were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety population. The number of participants available at that particular time point were used for analysis.|||IU/L||Standard Deviation|Mean
1373466|NCT01527110|Primary|Mean Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Albumin and total protein were measured at Baseline , Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||g/L||Standard Deviation|Mean
1373467|NCT01527110|Primary|Number of Participants With Hematology Parameters of Basophiles, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell(WBC) Count, Hemoglobin and Hematocrit Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for hematology parameters were basophils 0 to 2 percentage (%), eosinophils 0 to 8%, lymphocytes 18 to 49%, monocytes 2 to 10%, total neutrophils 40 to 75%, platelet count 140 to 340 giga cells per liter (GI/L), WBC count 3.3 to 9 GI/L, hemoglobin 135 to 175 g/L and haematocrit 0.397 to 0.524 ratio. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3, and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
1373468|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Albumin and Total Protein Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were albumin 38 to 53 grams per liter (g/L) and total protein 67 to 83 g/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
1373469|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/ Bicarbonate, Chloride, Magnesium, Potassium, Sodium and Urea/ Blood Urea Nitrogen (BUN) Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were calcium 2.0958 to 2.5948 millimole per litre (mmol/L), carbon dioxide content/ bicarbonate 19.2 to 27.1 mmol/L, chloride 98 to 108 mmol/L, magnesium 0.7809 to 1.0275 mmol/L, potassium 3.5 to 5 mmol/L, sodium 137 to 147 mmol/L and urea/BUN 2.856 to 8.211 mmol/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
1373470|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Creatinine, Direct Bilirubin and Total Bilirubin Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were creatinine 41.548 - 69.836 micromole per litre (µmol/L), direct bilirubin 0 to 5.13 µmol/L and total bilirubin 3.42 to 20.52 µmol/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
1373471|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Creatine Kinase and Aspartate Amino Transferase (AST) Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were ALT 5 to 45 international units per litre [IU/L]), ALP 100 to 325 IU/L, creatine kinase 60 to 270 IU/L and AST 10 to 40 IU/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
1373483|NCT01527006|Secondary|Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the three options (yes, no and don't mind).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
1373472|NCT01527110|Primary|Number of Participants With Any Adverse Event (AE), Drug-related AE, Grade 3 and Grade 4 AE, Grade 3 and 4 Drug-related AE , AE Leading to Discontinuation of Study Drug or From Study, Serious AE (SAE), Drug-related SAE, Fatal AE and Drug-related Fatal AE|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. The grading of AEs and SAE’s for 3/4 (3= severe, 4= potentially life threatening ) and its classification as potentially drug-related was done based on the investigator's judgment.|Start of treatment (Day 1) up to follow-up (Day 33)|Safety Population comprised of all participants who received at least one dose of IV zanamivir.|||Participants|||Count of Participants
1373473|NCT01527006|Secondary|The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at planned visit and at EOT (the duration after the day of first study drug dose up to 7 days after the Extension Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to the planned/EOT visits compared to Baseline (Week 0).|Week 0 (Baseline), Week 11, Week 28, Week 52 or EOT|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Participants|||Number
1373474|NCT01527006|Secondary|Seizure-free Rate During the Overall Treatment Duration [Extension Phase]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. The percentage of participants who were seizure free was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as the percentage of participants.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Percentage of participants|||Number
1373475|NCT01527006|Secondary|50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the overall treatment duration. The percentage of responders was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as percentage of responders.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Percentage of responders|||Number
1373476|NCT01527006|Secondary|Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Percent change||Full Range|Median
1373477|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
1373478|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
1373479|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
1373480|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
1373481|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
1373482|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
1373750|NCT01523886|Secondary|Anti-emetics|Use of anti-emetics during the first 24 hours after surgery|During the first 24 hours after surgery|||||||
1373484|NCT01527006|Primary|Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]|C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F [L/h]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation.|From Day 8 up to Day 78|The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.|||ng/mL||Standard Deviation|Mean
1373485|NCT01527006|Secondary|Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
1373486|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
1373487|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
1373488|NCT01527006|Secondary|Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results.|For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase|The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.|||Participants|||Number
1373489|NCT01527006|Secondary|The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0).|Week 0 (Baseline), Week 11 or EOT|The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Participants|||Number
1373490|NCT01527006|Secondary|Seizure-free Rate During the Maintenance Period [Core Study]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization.|Week 9 to Week 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Percentage of participants|||Number
1373491|NCT01527006|Secondary|50% Responder Rate During the Maintenance Period-LOCF [Core Study]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Percent responders|||Number
1373505|NCT01526785|Secondary|Survival Rate at Week 52|Percentage of participants who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population.|||percentage of participants||95% Confidence Interval|Number
1373751|NCT01523886|Secondary|Nausea and Vomiting|The incidence of nausea and vomiting during the first 24 hours after surgery|The first 24 hours after surgery|||||||
1373492|NCT01527006|Primary|Apparent Clearance (CL/F) of Perampanel [Core Study]|CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation.|From Day 8 up to Day 78|The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.|||Liter per hour||Standard Deviation|Mean
1373493|NCT01527006|Secondary|Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Percent change||Full Range|Median
1373494|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Near Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol|||units on a scale||Standard Deviation|Mean
1373495|NCT01526902|Primary|Objective Vision Assessments: High Contrast Near Visual Acuity|Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol|||logMAR units||Standard Deviation|Mean
1373496|NCT01526902|Primary|Objective Vision Assessments: High Contrast Intermediate Visual Acuity|Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol|||logMAR units||Standard Deviation|Mean
1373497|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Intermediate Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol|||units on a scale||Standard Deviation|Mean
1373498|NCT01526902|Secondary|Subjective Overall Vision: High Contrast Distance Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol|||units on a scale||Standard Deviation|Mean
1373499|NCT01526902|Primary|Objective Vision Assessments: High Contrast Distance Visual Acuity|Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol|||logMAR units||Standard Deviation|Mean
1373500|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.|||percent predicted FVC||Standard Deviation|Mean
1373501|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.|||percent predicted FVC||Standard Deviation|Mean
1373502|NCT01526785|Secondary|Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52|GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale.The score for each dimension was expressed as a percentage of the maximum score for that dimension.Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 GMFM-88 data.|||percentage of total score||Standard Deviation|Mean
1373503|NCT01526785|Secondary|Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.|||Z score||Standard Deviation|Mean
1373504|NCT01526785|Secondary|Invasive Ventilator-Free Survival Rate at Week 52|Percentage of participants, who were invasive ventilator-free at week 52, are reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.|||percentage of participants||95% Confidence Interval|Number
1373752|NCT01523886|Secondary|Consumption of Analgesics|Consumption of analgesics during the first 24 hours after surgery|The first 24 hours after surgery|||||||
1373506|NCT01526785|Primary|Percentage of Participants Who Were Clinically Stable or Improved at Week 52|Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.|||percentage of participants||95% Confidence Interval|Number
1373507|NCT01526733|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360])|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]). Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable AUMC(0-360)/AUC(0-360) data.|||ratio||Standard Deviation|Mean
1373508|NCT01526733|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360])|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose Days 1 and 4|Participants who completed both phases of the study and with evaluable AUC(0-360) data.|||picomoles*minutes/liter||Standard Deviation|Mean
1373509|NCT01526733|Secondary|Time to 50% Total Glucose Infused (50%Gtot)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable 50%Gtot data.|||minutes||Standard Deviation|Mean
1373510|NCT01526733|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)|Early and late tGIR50%max are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable early and late tGIR50%max data.|||minutes||Standard Deviation|Mean
1373511|NCT01526733|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable tGIRmax data.|||minutes||Standard Deviation|Mean
1373512|NCT01526733|Secondary|Maximum Glucose Infusion Rate (GIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable GIRmax data.|||milligrams/kilogram/minute||Standard Deviation|Mean
1373513|NCT01526733|Primary|Early Insulin Exposure (%AUC[0-60])|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0 360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 60 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable %AUC(0-60) data.|||percentage of AUC(0-60)||Standard Deviation|Mean
1373514|NCT01526629|Primary|Remote Follow-up as an Alternative to Onsite Visit|Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD|13 months||||Participants|||Count of Participants
1373515|NCT01526577|Primary|Platelet Aggregation Test, Bleeding Test||pre-dose, up to 1 day post-dose|||||||
1373516|NCT01526577|Secondary|AUC||pre-dose, up to 3 days post-dose|||||||
1373517|NCT01526577|Primary|Pharmacodynamic Measurement|"Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test.~* Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section."|1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study||||percentage of platelet inhibition|||Number
1373518|NCT01526577|Primary|Adverse Events of LC23-1306||7 days (plus or minus 1 day)|||||||
1373519|NCT01526551|Primary|Number of Students Who Completed HPV Vaccination as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program|August 2012 -- June 2013||||participants|||Number
1373520|NCT01526551|Primary|Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program|August 2012-June 2013||||participants|||Number
1373521|NCT01526538|Secondary|Learning Task by Itami and Uno||At the baseline laboratory visit||||% correct||Standard Error|Mean
1373522|NCT01526538|Primary|Medication Side-effects|self-report of medication side effects (Units of Measure is the count of specific reported effects)|1 month post-treatment.||||Adverse event reports|||Number
1373523|NCT01526538|Primary|Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)|The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results|1 month post-treatment||||ng/ml||Standard Deviation|Mean
1373524|NCT01526343|Primary|Freedom From Atrial Tachyarrhythmias (ATAs)||ILR monitoring at 12 months|Participants with available data at 1 year and who were compliant with use of each device.|||Participants|||Number
1373525|NCT01526343|Primary|Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals||ILR monitoring obtained at 3, 6 and 12 months||||ATA episodes|||Number
1373526|NCT01526213|Primary|Primary Pharmacokinetic Measure: Area Under the Curve (AUC)||0-72 hours||||micromolar*hr||Full Range|Geometric Mean
1373550|NCT01525667|Secondary|Change From Day 0 to Week 26 in Muscle Volume.|Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.|Day 0 to Week 26||||mm3||Standard Error|Least Squares Mean
1373753|NCT01523886|Secondary|Duration of Anesthesia|Duration of anesthesia|From induction of anesthesia to patient ready to leave the operating theatre|||||||
1373754|NCT01523886|Secondary|Duration of Surgery|Duration of surgery|From surgical incision to last suture has been placed.|||||||
1373527|NCT01526148|Secondary|Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)|Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.|Screening and Week 16||||IR Score||Standard Deviation|Mean
1373528|NCT01526148|Primary|Time to Study Discontinuation|The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure|Week 16||||days||95% Confidence Interval|Mean
1373529|NCT01525927|Secondary|Identify Additional Toxicity of Treatment|To identify additional toxicity of treatment|During therapy and up to 5 years following completion of treatment|No study intervention or data collected- Zero (0) participants analyzed||||||
1373530|NCT01525927|Secondary|Assessment of Quality of Life Outcomes|Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function.|Baseline, during therapy and up to two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
1373531|NCT01525927|Secondary|Assess Distant Disease Control at 2 Years.|3.5 To assess distant disease control at 2 years.|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
1373532|NCT01525927|Secondary|Assess Locoregional Disease Control at 2 Years|To assess locoregional disease control at 2 years|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
1373533|NCT01525927|Secondary|Assess Overall Survival at 2 Years.|To assess overall survival at 2 years.|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
1373534|NCT01525927|Secondary|Progression-free Survival at 2 Years|assess Progression-free survival at 2 years.|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
1373535|NCT01525927|Secondary|To Define Objective Tumor Response Rates to Induction Chemotherapy and to Subsequent Radiation-based Treatment.|To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria.|Three months following completion of radiation therapy phase.|||||||
1373536|NCT01525927|Primary|Response (CR+PR) Status at 3 Months Post-therapy|"The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5).~Zero (0) participants analyzed"|3 months following completion of radiation phase|No study intervention or data collected.||||||
1373537|NCT01525849|Secondary|Recovery Time|Mean time (days) after procedure for participants to return to normal activities|6-months|All treated participants with 6-month follow-up.|||days||Standard Deviation|Mean
1373538|NCT01525849|Secondary|Complication Rate|Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure|Duration of study (minimum of 12 months)|All randomized participants|||Participants|||Count of Participants
1373539|NCT01525849|Secondary|Revision Rate|Number of participants requiring repeat sinus procedures|1-year|All treated participants with 1-year follow-up (or a revision surgery before 1-year follow-up if no 1-year follow-up).|||Participants|||Count of Participants
1373540|NCT01525849|Primary|Debridements|Number of postoperative debridements per participant|1-year|All treated participants|||debridements per participant||Standard Deviation|Mean
1373541|NCT01525849|Primary|Sinus Symptom Improvement|Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).|Baseline and 1-year|All treated participants with matched pair SNOT-20 data at baseline and 1-year.|||units on a scale||Standard Deviation|Mean
1373542|NCT01525745|Secondary|Survival|Progrsesion Free and Overall Survival|2 years|data not collected, therefore no analysis done||||||
1373543|NCT01525745|Secondary|Long Term Effects of Image-guided Radiosurgery/SBRT|Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord|2 years|data not collected, therefore no analysis done||||||
1373544|NCT01525745|Secondary|Quality of Life|Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D|2 years|data not collected, therefore no analysis done||||||
1373545|NCT01525745|Secondary|Duration of Pain Response|Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy|2 years|data not collected, therefore no analysis done||||||
1373546|NCT01525745|Primary|Pain Control as Measured by NPRS|Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy|2 years|study was terminated by the local IRB due to slow accrual. 1 participant withdrew consent and 1 participant did not complete the assigned arm treatment per protocol and then removed from study. left with 4 participants and data were not collected for any participants therefore no analysis has been done.||||||
1373547|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.|Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)|Day 0 to Week 26||||mm||Standard Error|Least Squares Mean
1373548|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .|Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis|Day 0 to Week 26||||Ratio||Standard Error|Least Squares Mean
1373549|NCT01525667|Secondary|Change From Day 1 to Week 12 in Mean Fiber Diameter.|Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.|Day 1 to Week 12||||microns||Standard Error|Least Squares Mean
1373551|NCT01525667|Primary|Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.|Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.|Day 0 to Week 26||||Newtons||Standard Error|Least Squares Mean
1373552|NCT01525641|Secondary|Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA|Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.|Week 52|Patients in safety set and with concomitant L-DOPA|||participants|||Number
1373553|NCT01525641|Secondary|Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA|"Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off."|Week 52|Patients in safety set and with concomitant L-DOPA.|||participants|||Number
1373554|NCT01525641|Secondary|Change From Baseline in the Modified Hoehn & Yahr to Last Observation|Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.|Baseline and week 52|Efficacy set|||Units on a scale||Standard Deviation|Mean
1373555|NCT01525641|Secondary|Change From Baseline in Total Score of the UPDRS Part III to Last Observation|"Change from baseline at the last observation in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III total score.~UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient’s physical status.~The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.~The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia."|Baseline and week 52|Efficacy set|||units on a scale||Standard Deviation|Mean
1373556|NCT01525641|Secondary|Clinical Global Impression of Effect|Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.|Week 52|Efficacy set: included all patients in the “safety set” except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease|||participants|||Number
1373557|NCT01525641|Primary|Percentage of Adverse Drug Reactions|Percentage of subjects with adverse drug reactions|From baseline up to week 52|Safety set|||percentage of participants|||Number
1373558|NCT01525628|Secondary|Number of Participants With Sustained Virological Response (SVR12)|Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.|12 weeks post treatment|Treated set (TRT): This subject set includes all patients who were dispensed trial medication and were documented to have taken at least one dose of trial drug.|||Participants|||Number
1373559|NCT01525628|Primary|AUC 0-12hr of Raltegravir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
1373560|NCT01525628|Primary|C12hr of Raltegravir|Concentration of an analyte in plasma at 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
1373561|NCT01525628|Primary|Cmax of Raltegravir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
1373562|NCT01525628|Primary|AUC 0-24hr of Tenofovir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
1373563|NCT01525628|Primary|C24hr of Tenofovir|Concentration of an analyte in plasma at 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
1373564|NCT01525628|Primary|Cmax of Tenofovir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
1373565|NCT01525628|Primary|AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373566|NCT01525628|Primary|Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373567|NCT01525628|Primary|AUC 0-infinity of Midazolam|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373568|NCT01525628|Primary|Cmax of Midazolam|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373569|NCT01525628|Primary|AUC 0-infinity of Tolbutamide|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373570|NCT01525628|Primary|Cmax of Tolbutamide|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373571|NCT01525628|Primary|AUC 0-infinity of Caffeine|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1373572|NCT01525628|Primary|Cmax of Caffeine|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373573|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373574|NCT01525628|Primary|C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373575|NCT01525628|Primary|Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373576|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373588|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 12 weeks of treatment|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
1373577|NCT01525628|Primary|C6hr of Deleobuvir Reduction Metabolite CD 6168|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373578|NCT01525628|Primary|Cmax of Deleobuvir Reduction Metabolite CD 6168|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373579|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373580|NCT01525628|Primary|C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373581|NCT01525628|Primary|Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373582|NCT01525628|Primary|AUC 0-6hr of Deleobuvir (BI 207127)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1373583|NCT01525628|Primary|C6hr of Deleobuvir (BI 207127)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373584|NCT01525628|Primary|Cmax of Deleobuvir (BI 207127)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1373585|NCT01525628|Primary|Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1373586|NCT01525628|Primary|C24hr of Faldaprevir (BI 201335)|Concentration of an analyte in plasma at 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373587|NCT01525628|Primary|Cmax of Faldaprevir (BI 201335)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373589|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 6 weeks of treatment|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
1373590|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed on day 1|1 day|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
1373591|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||units / seconds||Standard Error|Least Squares Mean
1373592|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||units / seconds||Standard Error|Least Squares Mean
1373593|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 1 day of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates slowing down in decline in breathing, i.e., favorable results."|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.|||units / seconds||Standard Error|Least Squares Mean
1373594|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 6 weeks of treatment.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
1373595|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) on Day 1.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.|||liters||Standard Error|Least Squares Mean
1373596|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||seconds||Standard Error|Least Squares Mean
1373597|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity on Day 1. Analysis of covariance model on log10 transformation data. Adjusted means are back transformed to report in original units. Standard errors (SEs) are calculated using the delta method.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.|||seconds||Standard Error|Least Squares Mean
1373745|NCT01524133|Primary|Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|Total Score; Range 0-136 with increasing PTSD severity as scores increase|24 weeks|All randomized patients who received treatment|||Scores on a scale||Standard Deviation|Mean
1373598|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 12 weeks of treatment.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
1373599|NCT01525615|Secondary|Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks|Key secondary endpoint was endurance time during endurance shuttle walk test to symptom limitation at 85% of predicted maximum oxygen consumption (VO2) peak after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Endurance shuttle walk test (ESWT) substudy set - This patient set included all patients in the Treated Set who had given informed consent for participating in the ESWT substudy and had a baseline and at least one post-baseline measurement during ESWT before or at Week 12 for the key secondary endpoint.|||seconds||Standard Error|Least Squares Mean
1373600|NCT01525615|Primary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks|Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||seconds||Standard Error|Least Squares Mean
1373601|NCT01525563|Secondary|Overall Clinical Response|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.|6 months|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.|||participants|||Number
1373602|NCT01525563|Secondary|Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment|To observe the evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.|6 months|To observe the evolution of duration of menstrual bleeding from baseline (all enrolled) to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment (EOT).|||Days||Standard Deviation|Mean
1373603|NCT01525563|Secondary|Overall Patient Satisfaction|The overall patient satisfaction was recorded on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied).|6 months|Overall at the EOT, of 910 patients population the overall satisfaction was assessed|||participants|||Number
1373604|NCT01525563|Secondary|Evolution of Pain During Menstruation From Baseline to End of Treatment|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline and end of treatment where 0 means no pain, and 10 means worst pain.|6 months|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline for all enrolled subjects and end of treatment where 0 means no pain, and 10 means worst pain.|||participants|||Number
1373605|NCT01525563|Secondary|Amount of Menstrual Bleeding From Baseline to End of Treatment|Assessment of average number of pads changed per day at baseline and at the end of treatment (EOT).|6 months|The amount of menstrual bleeding (based on no. of pads used per day) was analyzed for all subjects completing EOT and change was noted from baseline to EOT|||pads/day||Standard Deviation|Mean
1373606|NCT01525563|Secondary|Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT)|The evolution of cycle duration from baseline to EOT was assessed by mean cycle duration (in days) at baseline, separately in polymenorrhea and oligomenorrhea groups, and at the EOT. The patients were included in polymenorrhea group in case the cycle duration at baseline was less than 21 days and in oligomenorrhea group in case the cycle duration at baseline was greater than 35 days.|6 months|All patients were assessed for overall reduction in cycle duration (910).|||Days||Standard Deviation|Mean
1373607|NCT01525563|Primary|Percentage of Patients Reporting a Regular Cycle|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.|6 months|Intent-to-Treat Population|||percentage of participants||95% Confidence Interval|Number
1373618|NCT01525550|Secondary|Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662|Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)|Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.||||||
1373619|NCT01525550|Secondary|Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662|Area under the plasma concentration-time profile from time zero (pre-dose) to 24 hours post-dose. SU012662 is the metabolite of sunitininb.|Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)|Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.||||||
1373608|NCT01525550|Secondary|Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)|ECOG-PS performance status is used to assess how the disease affects the daily living abilities of the participant. It was measured on 6-point scale ranging from 0-5, where 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work; 2= ambulatory for more than 50 percent of waking hours and capable of all self-care but unable to carry out any work activities; 3= capable of limited self-care, confined to bed or chair >50 percent of waking hours; 4= completely disabled, not capable of any self-care, totally confined to bed or chair; 5= dead. A higher score indicated greater functional impairment. Only those ECOG-PS categories, in which at least one participant had data at any indicated time point were reported in this outcome measure. Not reported (NR) category included participants with unavailable ECOG performance status.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|Safety analysis set included all participants who received at least 1 dose of study medication. Here, “0 participants” in the “number analyzed” field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.|||participants|||Number
1373609|NCT01525550|Secondary|Number of Participants With Change From Baseline in Body Weight|Participants with increase of >=5 percent and decrease of >=5 percent from baseline in body weight were reported in this outcome measure.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1373610|NCT01525550|Secondary|Number of Participants With Change From Baseline in Physical Examinations Findings|Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1373611|NCT01525550|Secondary|Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)||Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1373612|NCT01525550|Secondary|Number of Participants With Change From Baseline in Vital Signs Abnormalities|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, body temperature and heart rate.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1373613|NCT01525550|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein), miscellaneous (pregnancy test, Chromogranin A). Clinically significant laboratory abnormalities were identified by the Investigator.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1373614|NCT01525550|Secondary|Number of Participants With Adverse Events (AEs) According to Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] Version 3.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.|Baseline up to 1226 days|"Safety analysis set included all participants who received at least 1 dose of study medication. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure."|||participants|||Number
1373615|NCT01525550|Secondary|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1226 days that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1373616|NCT01525550|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1226 days that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 1226 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1373617|NCT01525550|Secondary|Half Maximal Effective Concentration (EC50) of Sunitinib|Concentration of sunitinib in plasma at which 50 percent of the maximum effect was observed.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)|Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.||||||
1373637|NCT01525420|Primary|Number of Participants Who Stopped Smoking by 6 Month Post Treatment|30-Day point prevalence abstinence at 6 months post treatment|6 months||||participants|||Number
1373638|NCT01525407|Secondary|Recurrent or Progressive Malignancy|Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.|Up to 3 years||||probability||95% Confidence Interval|Number
1373620|NCT01525550|Secondary|Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662|Dose-corrected plasma trough concentration is calculated as: trough plasma concentration*(intended dose divided by actual dose). Intended dose was defined as the starting dose in the study and actual dose was defined as the last dose which the participant had received. SU012662 is the metabolite of sunitininb.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5|PK population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters.|||ng/mL||Standard Deviation|Mean
1373621|NCT01525550|Secondary|Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662|Ctrough is the minimum observed plasma concentration of drug. SU012662 is the metabolite of sunitinib.|Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1373622|NCT01525550|Secondary|Plasma Concentration of Soluble Protein Biomarker (sKIT)||Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to maximum duration of 1226 days)|sKIT analysis set: enrolled participants who received at least 1 dose of study drug, had at least 1 biomarker parameter from corresponding assay sample with both baseline and post-treatment assessment. Here, “0 participants” in “number analyzed” field=none of the participants were evaluable in given group at this time point, hence data not reported|||picogram per milliliter (pcg/mL)||Standard Deviation|Mean
1373623|NCT01525550|Secondary|Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)|EORTC QLQ-GI-NET 21 was a 21-item questionnaire. These 21 questions assesses endocrine symptoms, gastrointestinal (G.I.) symptoms, treatment related symptoms, social functioning, disease related worries, muscle/bone pain, sexual function, information/communication function and body image. Each item was answered on a 4-point scale: 1 =not at all, 2 =a little, 3 =quite a bit, 4 =very much; where higher scores indicated more severe symptoms/problems. Scores averaged, transformed to 0-100 scale; higher score=more severe symptoms.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, “0 participants” in the “number analyzed” field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.|||units on a scale||Standard Deviation|Mean
1373624|NCT01525550|Secondary|Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess the participant quality of life. First 28 questions used for evaluating 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Each question was assessed on 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much); high score represented high level of symptomatology/problem. Last 2 questions used for evaluating global health status (GHS)/quality of life. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, “0 participants” in the “number analyzed” field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.|||units on a scale||Standard Deviation|Mean
1373625|NCT01525550|Secondary|Percentage of Participants With Chromogranin A (CgA) Response|CgA response in participants was defined as having confirmed CgA CR or CgA PR, relative to the population with an elevated baseline CgA value in the blood. CgA CR was defined as decrease from a high baseline value of CgA in the blood to one that fell within the normal range. CgA PR was defined as a decrease of greater than or equal to 50 percent from a high baseline value of CgA. Normal baseline value of CgA in blood was 39.0 ng/mL. Confirmed responses were those that persisted for at least 4 weeks after initial documentation of response. Blood levels of CgA were assessed and percentage of participants with CgA response were reported.|Baseline until CgA response or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||percentage of participants||95% Confidence Interval|Number
1373626|NCT01525550|Secondary|Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment|IRR assessed TTR was defined as the time (in months) from date of enrollment in study until first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.|Baseline until first documented objective tumor response (up to 1226 days)|Analysis was performed on only those participants who had objective response as per IRR assessment.|||months||Full Range|Median
1373627|NCT01525550|Secondary|Duration of Response (DOR): Independent Radiological Review (IRR) Assessment|IRR assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR) that was subsequently confirmed to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.|Baseline until disease progression or death due to any cause (up to 1226 days)|Analysis was performed on only those participants who had objective response as per IRR assessment.|||months||95% Confidence Interval|Median
1373628|NCT01525550|Secondary|Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment|IRR assessed OR in participants was defined as having a CR or PR according to Choi criteria and sustained for at least 4 weeks. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on Computed tomography (CT) with no new lesions and no obvious progression of non-measurable disease. Percentage of participants with objective response were reported in this outcome measure.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||percentage of participants||95% Confidence Interval|Number
1373629|NCT01525550|Secondary|Time to Tumor Response (TTR): Investigator Assessment|Investigator assessed TTR was defined as the time (in months) from date of enrollment in study until date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. As per RECIST 1.0, CR was defined as disappearance of all target and non-target lesions and PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD.|Baseline until first documented objective tumor response (up to 1226 days)|Analysis was performed on only those participants who had objective response as per investigator assessment.|||months||Full Range|Median
1373630|NCT01525550|Secondary|Duration of Response (DOR): Investigator Assessment|Investigator assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR), that was subsequently confirmed, to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to RECIST 1.0, CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Progression as per RECIST version 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|Baseline until disease progression or death due to any cause (up to 1226 days)|Analysis was performed on only those participants who had objective response as per investigator assessment.|||months||95% Confidence Interval|Median
1373631|NCT01525550|Secondary|Percentage of Participants With Objective Response (OR): Investigator Assessment|Investigator assessed OR in participants was defined as having a complete response (CR) or partial response (PR) according to RECIST 1.0 and sustained for at least 4 weeks. CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Percentage of participants with investigator assessed OR were reported.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||percentage of participants||95% Confidence Interval|Number
1373632|NCT01525550|Secondary|Overall Survival (OS)|OS was defined as the time (in months) from date of enrollment in study to the date of death due to any cause. If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive or the study cut-off date. The analysis was performed by Kaplan-Meier method.|Baseline until death or study cut-off (up to 5 years)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||months||95% Confidence Interval|Median
1373633|NCT01525550|Secondary|Time to Tumor Progression (TTP): Investigator Assessment|Investigator assessed TTP was defined as the time (in months) from the date of enrollment in study until the date of first documentation of objective tumor progression. TTP calculated as (first event date minus date of enrollment plus 1)/30.4. Progression as per RECIST 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until first documented tumor progression (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||months||95% Confidence Interval|Median
1373634|NCT01525550|Secondary|Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment|IRR assessed PFS was defined as the time (in months) from the date of enrollment in study until the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. Progression as per RECIST 1.0 criteria was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||months||95% Confidence Interval|Median
1373635|NCT01525550|Primary|Progression-Free Survival (PFS): Investigator Assessment|Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant’s last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||months||95% Confidence Interval|Median
1373636|NCT01525420|Secondary|7-day and 24-hour Point Prevalence Quit Rates|7-day and 24-hour point prevalence quit rates|6-month|||||||
1373649|NCT01525329|Primary|Accumulation of Porphyrin (PpIX)|"The primary endpoint of this study will be the accumulation of PpIX at 3 h after MAL application (measured noninvasively, in each treated region).~(Region refers to the half-face or half-scalp area treated with PDT monotherapy, or the contralateral area treated with the 5-FU/PDT combination regimen)."|Day 7 of the study||||Change in PpIX signal (arbitrary units)||95% Confidence Interval|Mean
1373650|NCT01525238|Secondary|Number of Participants With Marked Urinalysis Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Blood, urine (Qualitative): >=2 (If Pre-Rx >= 1, >=2*Pre-Rx). Glucose, urine (Qualitative): >=1, (If Pre-Rx >=1, >=2*Pre-Rx). Protein, urine (Qualitative): >=2 (If Pre-Rx >=1, >=2*Pre-Rx). Red Blood Cells (RBC), urine (RBC per High Power Field (hpf)): >=2 (If Pre-Rx>=2, >=4). White Blood Cells (WBC), urine (hpf): >=2 (If Pre-Rx>=2, >=4).|Day 1 (Pre-dose) to Day 3|All treated participants with evaluable lab results|||participants|||Number
1373651|NCT01525238|Secondary|Number of Participants With Marked Abnormalities in Other Chemistry Testing|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Glucose, fasting serum (mmol/L): <0.8*LLN, >1.3*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN). Protein (grams per deciliter: g/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Albumin (g/L): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mmol/L): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)|Day 1 (Pre-dose) to Day 3|All treated participants|||participants|||Number
1373652|NCT01525238|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (micromoles per Liter (umol/L)): >1.5*ULN if Pre-Rx missing or <= ULN, >1.33*Pre-Rx if PreRx > ULN. Sodium (mmol/L): >1.05*ULN, 1.05*Pre-Rx if Pre-Rx>ULN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN). Potassium(mmol/L), Chloride (mmol/L), Calcium(mmol/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN).|Day 1 (Pre-dose) to Day 3|All treated participants|||participants|||Number
1373653|NCT01525238|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose (Day -1). Lab values that met the following criteria were marked as abnormalities: Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (x10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx). Leukocytes (x10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre- Rx>ULN, use >1.15*Pre-Rx or <LLN). Neutrophils (Absolute) (x10^3 c/uL): <=1.5. Lymphocytes (Absolute) (x10^3 c/uL): <0.75 or >7.5. Monocytes (Absolute) (x10^3 c/uL): >2.000. Basophils (x10^3 c/uL): >0.4. Eosinophils (Absolute) (x10^3 c/uL): >0.75. Blasts (Absolute) (x10^9 c/L) > 0.|Day 1 (Pre-dose) to Day 3|All treated participants|||participants|||Number
1373654|NCT01525238|Secondary|Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.|Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported.|Day 1 to Day 3|All treated participants|||participants|||Number
1373655|NCT01525238|Secondary|Mean Total Amount of Glucose Excreted in Urine Over 24 Hours|The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams.|Time of dose to 24 hours post-dose, Day 1 to Day 2|All treated participants with evaluable PD profiles|||grams||Standard Deviation|Mean
1373656|NCT01525238|Secondary|Mean Change in Fasting Plasma Glucose From Baseline Until Day 2|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable PD profiles|||mg/dL||Standard Deviation|Mean
1373657|NCT01525238|Secondary|Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable pharmacodynamic (PD) profiles|||mg/dL||Standard Deviation|Mean
1373658|NCT01525238|Secondary|Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||hours||Standard Deviation|Mean
1373659|NCT01525238|Secondary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1373660|NCT01525238|Secondary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1373746|NCT01523964|Primary|Number of Subjects With an Adverse Event.|Adverse events will be assessed during the time the subject is enrolled in the trial.|1 day||||participants|||Number
1373661|NCT01525238|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin 3-O-Glucuronide was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||hours||Full Range|Median
1373662|NCT01525238|Secondary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373663|NCT01525238|Primary|Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin|Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||Liters||Geometric Coefficient of Variation|Geometric Mean
1373664|NCT01525238|Primary|Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin|Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1373665|NCT01525238|Primary|Mean Plasma Half-life (T-HALF) of Dapagliflozin|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||hours||Standard Deviation|Mean
1373666|NCT01525238|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1373667|NCT01525238|Primary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1373668|NCT01525238|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles.|||hours||Full Range|Median
1373669|NCT01525238|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable pharmacokinetic (PK) profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1373670|NCT01525225|Secondary|Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities|Lower limit of normal (LLN); upper limit of normal (ULN); treatment (RX); pre-treatment (Pre-Rx); units per liter (U/L); millimoles per liter (mmol/L). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-RX >ULN or >1.25*ULN if Pre-RX <=ULN; aspartate aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;alanine aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;blood urea nitrogen mmol/L: >1.1*ULN if Pre-RX <=ULN or >1.2*Pre-RX if Pre-RX >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-RX <=ULN or >1.25*Pre-RX if Pre-RX >ULN; creatine phosphokinase U/L: >1.5*Pre-RX if Pre-RX>ULN or >1.5*ULN if Pre-RX <= ULN. Grams per liter (g/L); cells per liter (c/L). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (%): <0.85*pre-RX;erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN.|Day 1 to Day 8|Participants who received at least one dose of study drug.|||participants|||Number
1373671|NCT01525225|Primary|Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 up to Day 8, plus 30 days|All participants who received at least one dose of study drug.|||participants|||Number
1373672|NCT01525173|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Per protocol population included all qualified participants who completed three months of treatment.|||mm Hg||Standard Deviation|Mean
1373747|NCT01523899|Secondary|Clinical Outcome at One or Three Months|Recurrence of abscess within a three month time period|3 months||||Participants|||Count of Participants
1373673|NCT01524978|Secondary|Safety: Percentage of Participants With Adverse Event|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to approximately 3 years|The safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1373674|NCT01524978|Secondary|Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab|Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are type and number of dose limited toxicities observed.|Up to 28 days|All participants from Cohort 3b who received at least one dose of study medication.|||dose-limiting toxicities|||Number
1373675|NCT01524978|Secondary|Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab|Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are the maximum tolerated doses for each vemurafenib and cetuximab.|Up to approximately 3 years|All participants from Cohort 3b who received at least one dose of study medication.|||milligrams (mg)|||Number
1373676|NCT01524978|Secondary|Overall Survival (OS)|OS was defined as time between the first day of study treatment and date of death of any cause.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
1373677|NCT01524978|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first day of study treatment, until the first documented PD or death from any cause, whichever occurs first. RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG criteria: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
1373678|NCT01524978|Secondary|Time to Tumor Progression (TTP)|TTP was defined as time from the first day of study treatment to the first occurrence of progressive disease (PD). RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
1373679|NCT01524978|Secondary|Time to Response|Time to response was defined as the time from the first day of study treatment to the date of first CR, or PR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions. IMWG criteria: CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to < 200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
1373680|NCT01524978|Secondary|Duration of Response (DOR)|DOR was defined as the period from the date of initial PR or CR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria, until the date of PD or death from any cause. RECIST v1.1: PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
1373681|NCT01524978|Secondary|Overall Response Rate (ORR)|ORR: percentage of participants with an objective response (OR) (CR, PR, sCR or VGPR) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using RECIST v1.1. or IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||percentage of participants||95% Confidence Interval|Number
1373682|NCT01524978|Secondary|Percentage of Participants With Confirmed Clinical Benefit|Included were participants with confirmed PR or CR or Stable Disease (SD) that had lasted at least 6 months according to RECIST v1.1 or confirmed CR, PR, VGPR, sCR or SD for at least 6 months according to IMWG criteria. RECIST v1.1: PR: >/= 30% decrease in the sum of diameters of target lesions; CR: disappearance of all target lesions; SD: not meeting criteria for CR, PR or progressive disease (PD). IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow; SD: not meeting criteria for CR, VGPR, PR or PD.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||percentage of participants||95% Confidence Interval|Number
1373683|NCT01524978|Primary|Confirmed Best Overall Response Rate (BORR)|Confirmed BORR: percentage of participants with an objective response (OR) (complete response [CR], partial response [PR], stringent CR [sCR] or very good PR [VGPR]) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal free light chain (FLC) ratio and no clonal cells in bone marrow.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not.|||percentage of participants||95% Confidence Interval|Number
1373684|NCT01524913|Secondary|Jaw Function Limitation Scale (JFLS) Score|"The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8)."|Month 3|The population at this time point consists of study participants who received the intervention they were randomized to, were not lost to follow-up before the Month 3 visit, and completed assessments at the Month 3 visit (one participant did not provide JFLS data at the Month 3 time point).|||Participants|||Count of Participants
1373685|NCT01524913|Secondary|Jaw Function Limitation Scale (JFLS) Score|"The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8)."|Month 1|The population at this time point consists of study participants who received the intervention they were randomized to and were not lost to follow-up before the Month 1 visit.|||Participants|||Count of Participants
1373686|NCT01524913|Secondary|Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3|Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain.|Baseline (preoperation), Month 1, Month 3|The population for MIO analysis consists of participants having a measurement at each specified time point. The decline in the number of participants over time is due to participants who were lost to follow-up as the study progressed and one participant who attended the Month 3 visit but did not provide data for the MIO assessment.|||millimeters||Standard Deviation|Mean
1373687|NCT01524913|Primary|Change in Pain Between Baseline and Month 1 Scores|The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.|Baseline (preoperation), Month 1|The population at this time point consists of study participants who received their assigned intervention and were not lost to follow up by the Month 1 assessment.|||units on a scale||Standard Deviation|Mean
1373688|NCT01524900|Primary|Number of Patients Reporting Hepatic Events|Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.|up to 72 weeks||||participants|||Number
1373689|NCT01524900|Primary|Number of Patients Reporting Rash of Any Severity|Number of patients reporting rash of any severity as adverse event|up to 72 weeks|Patients TS|||participants|||Number
1373690|NCT01524900|Secondary|Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation|The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.|24 weeks|Patients from FAS|||participants|||Number
1373691|NCT01524900|Secondary|Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks|The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|baseline and week 24|Patients from FAS with documented MMAS-8 score at baseline and after 24 weeks.|||units on a scale||Standard Deviation|Mean
1373748|NCT01523899|Secondary|Participant Clinical Improvement Post-treatment at One Week|clinical improvement (decreasing erythema, pain, swelling, drainage, and presence or absence of fever) will be documented at 2-7 day phone follow up and 1 and 3 months|2 to 7 days||||Participants|||Count of Participants
1373692|NCT01524900|Secondary|Change in CD4+ Cell Count From Baseline to Week 24|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.|baseline and week 24|Patients from FAS with documented CD4+ at baseline and after 24 weeks.|||cells/mm^3||Standard Deviation|Mean
1373693|NCT01524900|Secondary|Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)|Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of < 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.|24 weeks|Patients from the Full analysis set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.|||participants|||Number
1373694|NCT01524900|Primary|Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation|The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.|up to 72 weeks|Patients from TS.|||participants|||Number
1373695|NCT01524887|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE||Throughout infusions, approximately 2-5 hours|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||infusions|Total number of infusions administered||Number
1373696|NCT01524887|Secondary|Number of Infusions Causally Associated With AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||infusions|Total number of infusions administered||Number
1373697|NCT01524887|Secondary|Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion||During or within 7 days of completion of an infusion||||infusions|Total number of infusions administered||Number
1373698|NCT01524887|Secondary|Number of Infusions Temporally Associated With AEs and/or SAEs|A temporal association was defined as an AE and/or SAE occurring during or within 72 hours of completion of an infusion, regardless of causality.|During or within 72 hours of completion of an infusion|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||infusions|Total number of infusions administered||Number
1373699|NCT01524887|Secondary|Number of Participants Experiencing Any AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||participants|||Number
1373700|NCT01524887|Secondary|Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||participants|||Number
1373701|NCT01524887|Secondary|Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)|The IADCQ is a 12-item validated questionnaire that has been developed to measure the emotional, physical, and social impact of care giving on AD caregivers. Higher scores on the IADCQ are associated with a higher impact. IADCQ total score range: 0 (no impact) - 48 (greatest impact). Each item can be scored either 0 (Not at all), 1 (A little), 2 (Somewhat), 3 (A lot), or 4 (Extremely). As this is a 12-item scale, the minimum possible score is 0 and the maximum possible score is 4x12 = 48.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
1373702|NCT01524887|Secondary|Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant´s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52, with lower scores associated with a lower quality of life.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
1373703|NCT01524887|Secondary|Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement||Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||mm^3||Standard Deviation|Mean
1373704|NCT01524887|Secondary|Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 10 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
1373713|NCT01524796|Secondary|Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Participants|||Number
1373705|NCT01524887|Secondary|ADCS-Clinical Global Impression of Change (CGIC) at 18 Months|The ADCS-CGIC is a validated categorical measure of change in a participant’s global clinical status between baseline and follow-up visits, based on interview of the participant and the caregiver by a skilled and experienced clinician who was blinded to treatment assignment. The ADCS-CGIC score is based on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1373706|NCT01524887|Primary|Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
1373707|NCT01524887|Primary|Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
1373708|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|After Baseline, Month 1, 2, 3 visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.|||Participants|Participants||Number
1373709|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|Before Baseline, Month 1, 2, 3 Visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.|||Participants|Participants||Number
1373710|NCT01524796|Secondary|Pregabalin Dose|"Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.|||Milligram (mg) per day||Standard Deviation|Mean
1373711|NCT01524796|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire|"WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.|||Units on a scale||Standard Deviation|Mean
1373712|NCT01524796|Secondary|Health-related Quality of Life Scale Score|"Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant’s health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.|||Units on a scale||Standard Deviation|Mean
1373714|NCT01524796|Secondary|Sleep Interference Scale Score|"Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated “pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3, Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.|||Units on a scale||Standard Deviation|Mean
1373715|NCT01524796|Primary|Change From Baseline In Least Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Units on a scale||Standard Deviation|Mean
1373716|NCT01524796|Primary|Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Units on a scale||Standard Deviation|Mean
1373717|NCT01524796|Primary|Change From Baseline In Average Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Units on a scale||Standard Deviation|Mean
1373718|NCT01524783|Secondary|Pharmacokinetics (PK)|A single blood sample to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin).|Visit 3 (Cycle 2, Study Day 29)|||||||
1373719|NCT01524783|Secondary|Time to Definitive Deterioration in WHO Performance Status Change During the Study|The estimated average duration is at least 5-8.5 months until disease progression. WHO Performance Status is a scale rated from 0 (normal) to 5 (dead) by a healthcare professional to assess the overall status of a patient. Deterioration is defined as an increase of at least one category compared to baseline.|Every visit up from randomization to 5 years|||||||
1373720|NCT01524783|Secondary|Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study|The estimated average treatment duration is at least 5-8.5 months until disease progression. CgA and NSE are potential biomarkers for tumor response. Change from baseline will be noted and correlated with tumor response.|Every visit from baseline up to 5 years|||||||
1373721|NCT01524783|Secondary|Disease Control Rate (DCR)|The estimated average treatment duration is at least 5-8.5 months until disease progression. DCR will be assessed per modified RECIST 1.0. DCR is the proportion of patients with best overall response of CR, PR or stable disease (SD).|5 years|||||||
1373722|NCT01524783|Secondary|Objective Response Rate (ORR)|ORR will be assessed per modified RECIST 1.0. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR).|Every Visit from randomization up to 5 years|||||||
1373723|NCT01524783|Secondary|FACT-G Total Score Over the Duration of the Study|FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions, scored 0 to 4, examining physical, social/family, emotional, and functional well-being. Deterioration is defined as a decrease by at least 7 points compared to baseline.|Every Visit from randomization up to 5 years|||||||
1373724|NCT01524783|Secondary|Overall Safety Evaluation of Everolimus Versus Placebo|The assessment of safety will be based mainly on the frequency and type of treatment emergent adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. vital signs) will be considered as appropriate. Safety events will be graded using the CTCAE V4.03 (Common Terminology Criteria for Adverse Events).|Every visit from randomization up to 5 years|||||||
1373725|NCT01524783|Secondary|Overall Survival (OS) Using Kaplan-Meier|OS is defined as the time from the date of randomization to date of death due to any cause.|Every visit from randomization up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.|||Percentage of participants||95% Confidence Interval|Number
1373726|NCT01524783|Primary|Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier|PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by cat scan (CT) and/or magnetic resonance imaging (MRI).|From date of randomization to progression or death up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.|||Percentage of participants||95% Confidence Interval|Number
1373727|NCT01524770|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide with evaluable concentration-time data.|||hours||Full Range|Median
1373728|NCT01524770|Primary|Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1373729|NCT01524770|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.|||nanograms times hours per milliliters||Geometric Coefficient of Variation|Geometric Mean
1373730|NCT01524692|Secondary|Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus|Assess archival tumor samples for the expression of MYB protein and chromosomal rearrangements of the MYB locus.|Anticipated Reporting Date 2020||2020-12-31|12/2020||||
1373743|NCT01524198|Primary|Patients Hospitalization Rate|The number of patients hospitalized over the study period (17 months).|17 months||||participants|||Number
1373731|NCT01524692|Secondary|Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas.|Collect descriptive data about the change in tumor growth rates as measured by the change point method. Tumor growth rate is defined as the estimated slope from tumor measurements taken prior to treatment (TG0). TG0 is compared with TG1 (tumor growth rate) as defined by the estimated slope after treatment (months 0 to 4). Each patient's tumor growth profile will be allowed one change point, one slope measured from pre-study (-6 months to time 0, change point at time 0) and the other slope (time 0 to time 4 months). Change in slope will be assessed. Slope is measured on a plot of time on the x axis and sum of longest diameters of RECIST target lesions on the y axis. Slope is then defined as Y1-Y0 divided by X1-X0. The slope of the tumor growth curve (plotted as sum of longest diameters vs month since starting dovitinib) is measured at time points TG0 and TG1.|TG0 was measured from -6 months to time 0. TG1 is defined as time 0 to time 4 months.|All treated patients were required to submit pre-study cross sectional imaging from preceeding 6months in order to establish pre-study tumor growth rates.|||cm/month||Standard Error|Mean
1373732|NCT01524692|Secondary|Quality of Life Measurements During TKI258 Treatment.|Participants were asked to fill out FACT-G (Functional Assessment of Chronic Illness Therapy) quality of life questionnaires at baseline and off-treatment visit. This scale measures physical well-being, social/family well-being, emotional well-being, and functional well-being on a 5 point Likert scale. Scores range from 0 to 4 on a Likert scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The raw score range for each subscale is 0-28 points and the total score range is 0-108. Higher values represent higher well-being in each functional subscale. The mean difference from baseline to off-study assessment are presented with range from minimum to maximum.|Baseline FACT-G questionnaire and FACT-G questionnaire at time of off-treatment visit (average of 8.2 months)|All participants filled out quality of life questionnaires.|||units on a scale||Full Range|Mean
1373733|NCT01524692|Secondary|The Adverse Event Profile of TKI258 in Subjects Who Have ACC.|Adverse events were collected per CTCAE v3.|From enrollment up to 36months||||Participants|||Count of Participants
1373734|NCT01524692|Secondary|Estimate the Progression-free Survival Following Treatment With TKI258.|PFS is measured from enrollment up to first progression event (median= 8.2 months). 1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan.|From enrollment up to first progression event||||Months||90% Confidence Interval|Median
1373735|NCT01524692|Primary|Determine the Objective Tumor Response Rate Following Treatment With TKI258|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by cross sectional imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From enrollment up to 36months|1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan.|||Participants|||Count of Participants
1373736|NCT01524627|Primary|Cigarettes Per Day|Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled|last week of treatment (1-8 weeks)|Population was the number of randomized subjects who participated in any treatment length. One subject per group was not included in this analysis as one withdrew a few days after their first scan and the other was lost to follow up after their first scan.|||cigarettes per day||Standard Error|Mean
1373737|NCT01524302|Primary|Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).~These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively."|2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug||||Log inhibition|||Number
1373738|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.|To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||mg*hr/L||Standard Deviation|Mean
1373739|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||hours||Standard Deviation|Mean
1373740|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||liters per hour||Standard Deviation|Mean
1373741|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||Liters||Standard Deviation|Mean
1373742|NCT01524198|Secondary|Change in Asthma Score From Baseline as Compared to the Score at Disposition|A negative change of asthma score from baseline measurement to measurement at disposition, which could be at 2, 3, or 4 hours time points would indicate a decrese in asthma severity. The asthma score ranged between 5 and 15 points as in the protocol, where 5 is the mildest and 15 is the most severe.|2, 3, or 4 hours from baseline||||units on asthma score||Standard Deviation|Mean
1373762|NCT01523886|Primary|The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less|The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 (“optimal”) = “optimal” surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.|From surgical incision to last suture has been placed, an expected average of 30 minutes||||percentage of patients|||Number
1373763|NCT01523873|Secondary|Diagnostic Quality|"Diagnostic quality was assessed by the radiologist by answering the question could you come to a diagnostic ? (answer : yes or no)."|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 308 patients.|||participants|||Number
1373764|NCT01523873|Secondary|Image Quality|Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 164 patients.|||participants|||Number
1373765|NCT01523873|Secondary|Nephrogenic Systemic Fibrosis Incidence|For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.|Follow-up of at least 3 months after magnetic resonance examination|Patients of the Safety Population with moderate to severe impaired renal function.|||participants|||Number
1373766|NCT01523873|Primary|Frequency of Adverse Events|Adverse Events were notified and described.|During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).||||Adverse Events|||Number
1373767|NCT01523782|Secondary|Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2|"CR was defined using:~Clinical criteria: disappearance of clinical signs of acute lymphocytic leukemia (ALL)~Blood criteria: neutrophils > 1 G/L and platelets >100 G/L~Medullary criteria: normally rich bone marrow and percentage of blasts <5%"|1 and 2 months|28 patients were analyzed for CR after Induction 1 (2 pts in 50 IU/kg; 13 pts in 100 IU/kg; 13 pts in 150 IU/kg). 22 patients were analyzed for CR after Induction 2 (2 pts in 50 IU/kg; 11 pts in 100 IU/kg; 9 pts in 150 IU/kg).|||Participants|||Count of Participants
1373768|NCT01523782|Secondary|Number of Patients Positive for Anti-L-asparaginase Antibodies|Evaluation of the number of patients testing positive for anti-asparaginase antibodies.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||Participants|||Count of Participants
1373769|NCT01523782|Secondary|Summary of Encapsulated Asparaginase (U/L) Over Time||Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||U/L||Standard Deviation|Mean
1373770|NCT01523782|Secondary|Summary of Free Asparaginase Over Time||Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||U/L||Standard Deviation|Mean
1373771|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Glutamic Acid|Mean cerebral spinal fluid glutamic acid concentration|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373772|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Glutamine|Mean cerebral spinal fluid glutamine concentration|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373773|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Aspartic Acid|Mean cerebral spinal fluid aspartic acid concentration|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373774|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Asparagine|Mean cerebral spinal fluid asparagine concentration over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373775|NCT01523782|Secondary|Plasma Concentrations of Glutamic Acid.|Mean glutamic acid concentration over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373776|NCT01523782|Secondary|Plasma Concentrations of Glutamine|Mean glutamine concentration over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373777|NCT01523782|Secondary|Plasma Concentrations of Aspartic Acid|Mean plasma concentration of aspartic acid over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373778|NCT01523782|Secondary|Plasma Concentrations of Asparagine|Mean plasma concentration of asparagine over time. Participants who were Below the Lower Limit of Quantification (BLLQ) were assigned a value of 0.51 μmol/L.|Induction 1 & Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
1373790|NCT01523587|Secondary|Disease Control According to RECIST 1.1|Disease control (defined as CR, PR or Stable Disease (SD)) according to RECIST 1.1.|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.|||participants|||Number
1373779|NCT01523782|Secondary|Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2|"Safety: Toxicity, assessed during Induction 1 and Induction 2: according to NCI-CTCAE v3.0 August 2006, with Dose Limiting Toxicities (DLT) defined as: Grade 2, 3, 4 of pancreatic toxicity, Grade 3 or 4 hepatic toxicity, allergic toxicity or deep cerebral thrombosis, known as potentially related to L-asparaginase; hematological toxicity defined as bone marrow blast free aplasia, 30 days following the last injection of chemotherapy, all other Grade 4 toxicities.~Information in a previous submission of this record indicated that Number of Participants with DLTs was included as a Secondary Outcome Measure, however only the number of DLTs is a pre-specified Secondary Outcome Measure."|Induction 1 and Induction 2|22 total DLTs occurred.|||DLTs|||Number
1373780|NCT01523782|Primary|Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment|The main evaluation criterion is a composite efficacy/toxicity criterion. Efficacy, assessed during induction 1: percentage of patients responding to treatment, i.e. with plasma Asn concentration ≤2µM (depleted), for a duration of at least 7 days after the administration of GRASPA®|7 days after the first administration of GRASPA® during Induction 1||||Participants|||Count of Participants
1373781|NCT01523756|Primary|Leakage Under the Base Plate Using a 24-point Scale|Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)|Each product will be tested 2 weeks||||units on a scale|Participants|Standard Deviation|Mean
1373782|NCT01523743|Primary|Quality of Life (0-100 Point)|Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.|6 weeks|The primary analysis was based on the ITT population which included 118 subjects. 7 subjects were excluded from the ITT population. They were excluded because they discontniued the investigation and only baseline data was collected from them. Furthermore, not all subjects in the ITT population answered the QoL questionaire for both products.|||units on a scale||Standard Deviation|Mean
1373783|NCT01523613|Secondary|Restored Tooth Performance|"Cut-off: Restored tooth failure (tooth in need of repair or management) as determined by Tooth integrity (enamel/tooth fracture), Sensitivity and Vitality assessment within both arms.~Clinically successful is defined as: No need for repair or management due to sensitivity or loss of tooth integrity or vitality."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).~48 Subjects with a single restoration (23 R, 25 F)."|||Restored tooth|Restored tooth||Count of Units
1373784|NCT01523613|Secondary|Caries Incidence Associated With Restoration|"- Caries free restorations is defined as: free of caries associated with restoration."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).~48 Subjects with a single restoration (23 R, 25 F).~In Total: 69 subjects, 90 restorations."|||Restoration|Restoration||Count of Units
1373785|NCT01523613|Primary|Survival Rate|"Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms.~Clinically successful is defined as: no need for replacement due to fracture or retention losses."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).~48 Subjects with a single restoration (23 R, 25 F).~Recall total: 69 subjects, 90 restorations.~No retention losses: all restorations (both R and F) in-situ and bonded; no exposed dentin."|||Restorations|Restorations||Count of Units
1373786|NCT01523587|Secondary|Change in Score Over Time in Coughing,Dyspnoea and Pain|"Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race.~Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.~The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table)."|First treatment administration up to 28 days after last intake of study medication|Randomised set i.e. all patients who were randomised regardless of whether they received investigational treatment.|||units on a scale||Standard Error|Mean
1373787|NCT01523587|Secondary|Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.|Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.|First treatment administration up to 28 days after the last intake of study medication.|Randomised set i.e. all patients who were randomised, regardless of whether they received investigational treatment.|||months||95% Confidence Interval|Median
1373788|NCT01523587|Secondary|Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire|"Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30 questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at EOT and follow up prior to clinical assessment. The results displayed show improvement in the relevant criteria.~For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The proportion of patients that were improved: Change in cough; dyspnoea and pain scores over time."|First treatment administration up to 28 days after the last intake of study medication.|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.|||participants|||Number
1373789|NCT01523587|Secondary|Tumour Shrinkage|"Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review.~The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation.~A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size."|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.|||percentage of decrease||Standard Deviation|Mean
1373791|NCT01523587|Secondary|Objective Response According to RECIST 1.1|Objective response as defined by RECIST 1.1 as either complete response (CR) or partial response (PR).|First treatment administration until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.|||participants|||Number
1373792|NCT01523587|Secondary|Overall Survival|"The primary analysis of Overall Survival (OS) will be conducted after 632 deaths have occured.~Overall Survival is defined as the time from randomisation to death."|From randomisation until 632 deaths||2018-11-30|11/2018||||
1373793|NCT01523587|Primary|Progression-free Survival, Based on Central Independent Review as Determined by RECIST 1.1|The primary endpoint of this study was Progression Free Survival (PFS), as determined by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. PFS was defined as the time from randomisation to disease progression (or death if the patient died before progression).|First treatment administration up until cut off date of 7th October 2013 (up to 78 weeks).|Randomised Set i.e. all patients who were randomised, regardless of whether they received investigational treatment.|||Months||95% Confidence Interval|Median
1373794|NCT01523496|Secondary|Changes in Vitamin D Binding Protein (VDBP)|Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.|6 months|HIV-infected children and young adults and matched healthy control group. Results were not analyzed were captured comparing HIV+ young adults on control or supplementation vit D to HIV - controls|||ng/mL||Inter-Quartile Range|Median
1373795|NCT01523496|Primary|Changes in Serum 25(OH)D3 Levels|Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )|6 months|HIV-infected on vitamin D control or supplementation dose and matched HIV-uninfected group on control or supplementation dose|||ng/mL||Inter-Quartile Range|Median
1373796|NCT01523457|Secondary|Correlate Time to Progression, Objective Response, and Overall Survival With Early Changes in Glucose Metabolism Using FDG-positron Emission Tomography (PET) Scanning|The time to progression, objective response rate, and overall survival will be correlated with early changes in glucose metabolism using FDG-positron emission tomography (PET) scanning in patients with metastatic disease and locally advanced disease.|24 weeks|This outcome was included in the 2012 protocol registration and actually describes a series of analyses that were not fully conducted, and will not be. The outcome measures described in the outcome description are presented as separated outcome measures elsewhere in this results record.||||||
1373797|NCT01523457|Secondary|Rate of Resection in Patients With Locally Advanced Disease|The rate of surgical resection in the cohort of patients with locally advanced disease will be determined.|24 weeks|Only LAPC patients were considered in the analysis. 13 patients in the LAPC group had surgical resection. The definition of locally unresectable and borderline were clarified in the protocol.|||participants|||Number
1373798|NCT01523457|Secondary|Toxicity|Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0. Rates of grade 3 and 4 toxicities will be compared to historical controls. MPC and LAPC are combined because they were given the exact same medication. The study aimed to compare this dosage with historical dosage, so this comparison is the most appropriate.|24 weeks|One of the total 75 patients did not receive treatment and was excluded from toxicity analysis. Treatment-related grade 3 and 4 adverse events observed in our study and in the historical control group treated with standard FOLFIRINOX.|||participants|||Number
1373799|NCT01523457|Secondary|Overall Survival|Overall survival will be determined in patients with metastatic disease and in patients with locally advanced disease.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).|||percentage of participants|||Number
1373800|NCT01523457|Secondary|Objective Response Rate|Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1 by independent radiology review) at 8 week intervals in patients with metastatic disease and in patients with locally advanced disease.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).|||percentage of participants|||Number
1373801|NCT01523457|Primary|Progression Free Survival|The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of FOLFIRINOX. Tumour response was determined according to RECIST 1.1 by independent radiology review.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).|||percentage of participants|||Number
1373802|NCT01523392|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available|||ng/mL||Standard Deviation|Geometric Mean
1373803|NCT01523392|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available|||ng/mL||Standard Deviation|Geometric Mean
1373804|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8||At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
1373805|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose||At 0.5 hour and 8 hours after the loading dose|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
1373806|NCT01523392|Primary|Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose||At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=32) - included all participants for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel|||PRU||95% Confidence Interval|Least Squares Mean
1373807|NCT01523366|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The SD is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|PK Analysis Set|||ng/mL||Standard Deviation|Geometric Mean
1373808|NCT01523366|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set, defined as all participants for whom at least one valid PK reading was available|||ng/mL||Standard Deviation|Geometric Mean
1373809|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8|The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
1373810|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 0.5 and 8 hours after the loading dose|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
1373811|NCT01523366|Primary|Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
1373812|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)|The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373813|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)|The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373814|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)|The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373815|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (Motor Subscale)|Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson’s disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373816|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)|The UPDRS Part II is a tool to measure Activities in Daily Living – it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373841|NCT01522456|Post-Hoc|Fitzpatrick Skin Type User Preference Survey at Day 22|User Preference Survey at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type. Fitzpatrick skin type (FST) is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). Two subjects did not participate in the User Preference Survey; as a result, 2 subjects were not included in the FST I - III group results below.|Day 22||||participants|||Number
1373817|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)|The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373818|NCT01523301|Primary|Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)|The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
1373819|NCT01522976|Secondary|Toxicity Rate|Adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Analysis includes only eligible patients who also received treatment.|||Participants|||Number
1373820|NCT01522976|Secondary|Pre-study Cytogenetic Abnormalities|Cytogenetic risk group is used to identify cytogenetic abnormalities.|Up to 5 years|Analysis includes eligible patients only.|||participants|||Number
1373821|NCT01522976|Secondary|Overall Survival|OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow- up for patients last known to be alive is censored at the date of last contact. OS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients only.|||Days||95% Confidence Interval|Median
1373822|NCT01522976|Secondary|Relapse-free Survival|RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients who had a response.|||Days||95% Confidence Interval|Median
1373823|NCT01522976|Primary|Overall Survival (Phase III)|OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.|Up to 5 years|This trial did not proceed to the Phase III portion. Therefore, no patients were analyzed for this outcome measure.||||||
1373824|NCT01522976|Primary|Response Rate (Phase II)|A response is any of complete hematological remission, partial remission, or hematologic improvement.|Up to 5 years|Analysis includes eligible patients only.|||percentage of patients having a response||95% Confidence Interval|Number
1373825|NCT01522963|Primary|Nicotine Withdrawal Symptoms|The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.|5 to 35 minutes||||units on a scale||95% Confidence Interval|Least Squares Mean
1373826|NCT01522963|Primary|Craving|The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1373827|NCT01522937|Secondary|The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding|Grade 4 toxicities are life threatening toxicities that require urgent attention.|1 Year||||patients|||Number
1373828|NCT01522937|Secondary|The Number of Patients Who Experience Grade 4+ Hepatotoxicity|Grade 4 toxicities are life threatening toxicities that require urgent attention.|1 Year||||patients|||Number
1373829|NCT01522937|Secondary|The Percentage of Patients Alive at 1 Year||1 Year||||percentage of patients||95% Confidence Interval|Number
1373830|NCT01522937|Secondary|The Percentage of Patients Alive Without Progression at 1 Year|Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement|1 Year||||percentage of patients||95% Confidence Interval|Number
1373831|NCT01522937|Primary|The Percentage of Patients With Local Control at 1 Year Post Treatment|For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.|1 Year||||percentage of patients||95% Confidence Interval|Number
1373832|NCT01522924|Primary|Change From Baseline in Tobacco Cessation Knowledge Score|The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.|Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
1373842|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Stinging/Burning. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
1373833|NCT01522924|Primary|Change From Baseline in Intentions Score|Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
1373834|NCT01522924|Primary|Change From Baseline in Self-efficacy Score|Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.|Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
1373835|NCT01522924|Primary|Change From Baseline in Perceived Skills Score|The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
1373836|NCT01522924|Primary|Change From Baseline in Subjective Norms Score|Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.|Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The number of participants for analysis was determined by the completing the questionnaire after the lecture or after the counseling practice sessions using standardized patients.|||units on a scale||Standard Deviation|Mean
1373837|NCT01522924|Primary|Change From Baseline in Perceived Barriers Score|The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)|The number of participants for analysis was determined by completing the second questionnaire after the lecture or after the counseling practice sessions using standardized patients.|||units on a scale||Standard Deviation|Mean
1373838|NCT01522924|Primary|Change From Baseline in Attitude Score|"The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) It is important for members of the profession to discuss tobacco use with patients and 2.) A brief intervention (3 minutes) for tobacco cessation with my patients would be effective. The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2."|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The control group (lecture only) completed the second questionnaire after the lecture and the intervention group (counseling practice sessions) completed the second questionnaire after the counseling practice sessions and the debriefing session.|||units on a scale||Standard Deviation|Mean
1373839|NCT01522703|Primary|Exhaled Nitric Oxide Concentrations|exhaled nitric oxide concentrations|at 3 days||||ppb||Inter-Quartile Range|Median
1373840|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Overall Tolerability Preference Survey Results|Overall Tolerability Preference Survey Results at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type (FST). Data collected from available subjects on day 22. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). One subject did not participate in the User Preference Survey; as a result, 1 subject was not included in the FST I - III group results below.|Day 22||||participants|||Number
1373843|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Dryness. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
1373844|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Scaling. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
1373845|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Erythema. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
1373846|NCT01522456|Other Pre-specified|Overall Tolerability Preference Survey|Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.|Day 22|Safety population|||participants|||Number
1373847|NCT01522456|Secondary|Cumulative Tolerability (Combined)|Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
1373848|NCT01522456|Secondary|Cumulative Tolerability (Stinging/Burning)|Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
1373849|NCT01522456|Secondary|Cumulative Tolerability (Dryness)|Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
1373850|NCT01522456|Secondary|Cumulative Tolerability (Scaling)|Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
1373851|NCT01522456|Secondary|Cumulative Tolerability (Erythema)|Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
1373852|NCT01522456|Secondary|Tolerability at Day 22 (Stinging/Burning)|Tolerability assessments at day 22 for stinging/burning|Day 22|Safety population|||participants|||Number
1373853|NCT01522456|Primary|Worst Postbaseline Tolerability (Stinging/Burning)|Worst postbaseline tolerability assessments for stinging/burning|Day 1 - Day 22|Safety population|||participants|||Number
1373854|NCT01522456|Secondary|Tolerability at Day 22 (Scaling)|Tolerability assessments at day 22 for scaling|Day 22|Safety population|||participants|||Number
1373855|NCT01522456|Primary|Worst Postbaseline Tolerability (Dryness)|Worst postbaseline tolerability assessments for dryness.|Day 1 - Day 22|Safety population|||participants|||Number
1373856|NCT01522456|Primary|Worst Postbaseline Tolerability (Scaling)|Worst postbaseline assessment for scaling.|Day 1 - Day 22|Safety population|||participants|||Number
1373857|NCT01522456|Other Pre-specified|User Preference Survey (Subjects)|"Response from subjects when asked: Which side of the face feels less irritated? Data collected from available participants on each assessment day."|Day 5, day 12, day 19, and day 22|Safety population|||participants|||Number
1373858|NCT01522456|Other Pre-specified|User Preference Survey (Investigator)|"Response from investigator when asked: Which side of the face appears to be less irritated? Data collected from available participants."|Day 5, day 12, day 19, and day 22|Safety population|||participants|||Number
1373859|NCT01522456|Secondary|Tolerability at Day 22 (Dryness)|Tolerability assessments at day 22 for dryness|Day 22|Safety population|||participants|||Number
1373860|NCT01522456|Secondary|Tolerability at Day 22 (Erythema)|Tolerability assessments at day 22 for erythema|Day 22|Safety population|||participants|||Number
1373861|NCT01522456|Primary|Worst Postbaseline Tolerability (Erythema)|Worst postbaseline tolerability assessment for erythema.|Day 1 - Day 22|Safety population|||participants|||Number
1373862|NCT01522443|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates.|OS was measured at the time of randomization until 78 deaths|The Intent to Treat (ITT) population was used and included 119 randomized subjects (61 cabozantinib, 58 mitoxantrone plus prednisone) at the time of primary analysis (data cut off date: 06 October 2014).|||months||95% Confidence Interval|Median
1373863|NCT01522443|Secondary|Bone Scan Response (BSR)|BSR is defined as >=30% in the bone scan lesion area (BSLA) compared with baseline. Bones scans were evaluated by an independent radiology facility (IRF) for response.|BSR was measured at the end of Week 12 as determined by the IRF|Analysis was conducted on the randomized ITT population (61 cabozantinib, 58 mitoxantrone plus prednisone) for BSR at Week 12.|||percentage of responders||95% Confidence Interval|Number
1373877|NCT01521923|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2|"LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2.~DAS28 values range from 2.0 to 10.0 with a higher value indicating a higher disease activity."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373864|NCT01522443|Primary|Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported|The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline.|Pain response was measured at Week 6 and Week 12 by self-reports of subjects|The primary analysis of pain response was based on the Intent to Treat (ITT) population of 119 participants (61 cabozantinib, 58 mitoxantrone plus prednisone).|||percentage of responders||95% Confidence Interval|Number
1373865|NCT01522339|Secondary|MRI Image Quality|The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.|Post MRI Scan for Each Infant|Number of NICU MRI Images with Equal or Better Quality than Adult Scanner Images|||Images|||Number
1373866|NCT01522339|Primary|Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam|Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.|Day 1||||Adverse Events|||Number
1373867|NCT01522235|Secondary|Orthostatic Hypotension Symptom Assessment Questionnaire|"To determine the change in orthostatic Hypotension symptom (measured by the orthostatic hypotension symptom assessment questionnaire) measured at baseline and 6 weeks in individuals receiving IVIG. This is a 60 point orthostatic hypotenstion symptom assessment questionnaire. The minimum score possible is 0 and maximum is 60.~Higher values represent worse outcome. We are reporting the total score."|Baseline, 6 weeks||||units||Standard Deviation|Mean
1373868|NCT01522235|Secondary|EuroQol [EQ-5D] Questionnaire.|"To determine the change in quality of life (measured by the EuroQol [EQ-5D]) measured at baseline and 6 weeks in individuals receiving IVIg. We have reported the subscale (EQ-VAS). The minimum score is 0 and maximum score is 100. (0) corresponds to  the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine."|Baseline, 6 weeks||||units||Standard Deviation|Mean
1373869|NCT01522235|Secondary|Composite Autonomic Severity Score (CASS) Questionnaire.|"To determine the change in autonomic symptoms (measured by the composite autonomic severity score [CASS]) measured at baseline and 6 weeks in individuals receiving IVIg.~Is a 10-point composite autonomic scoring scale of autonomic function. This scale allots 4 points for adrenergic and 3 points each for sudomotor and cardiovagal failure. Subjects with a score of 3 or less on have a mild autonomic failure, 4-6 have moderate autonomic failure and those with scores of 7 to 10 have severe failure. The minimum score possible is 3 and maximum is 10."|Baseline, 6 weeks||||units||Standard Deviation|Mean
1373870|NCT01522235|Secondary|Composite Autonomic Symptom Score [COMPASS] Questionnaire|To determine the change in autonomic symptoms (measured by the composite autonomic symptom score [COMPASS] questionnaire) measured at baseline and 6 weeks. Minimum and maximum score possible: 0-100. We have reported the Total score. Higher values represent worse outcome.|Baseline, 6 weeks||||units||Standard Deviation|Mean
1373871|NCT01522235|Secondary|Change in Systolic Blood Pressure During 60° Tilt (ΔSBP)|To compare the change in systolic blood pressure during 60 degree head up tilt table test after 6 and 12 weeks of IVIG (the within-patient difference in ΔSBP at 12 and 6 weeks among treated patients).|6 weeks and 12 weeks||||mmHg||Standard Deviation|Mean
1373872|NCT01522235|Primary|Change in Systolic Blood Pressure During 60° Tilt (ΔSBP)|The primary outcome, the change in systolic blood pressure during 60 degree tilt (ΔSBP), will be assessed in all study participants at baseline and at 6 weeks.|Baseline and 6 weeks||||mmHg||Standard Deviation|Mean
1373873|NCT01522131|Secondary|Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)|Patients with periodontitis lose bone and clinical attachment over a period of time in vertical direction also. In both control and test a UNC probe marked in mm was used to quantify this loss or gain of clinical attachment in a vertical direction from the cemento-enamel junction to the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done.This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. Increase and decrease of vertical probing depth will be noted by a positive number.|At Baseline and 6 months||||mm||Standard Deviation|Mean
1373874|NCT01522131|Primary|Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.|Patients with periodontitis lose bone and clinical attachment over a period of time. In both control and test a Nabers probe( curved probe) marked in mm was used to quantify this loss or gain of clinical attachment in a horizontal direction from the cemento-enamel junction to the the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done. This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. If there is a loss in attachment it will be denoted by negative number. If theres a gain in attachment it will be denoted by a positive number after the comparison.|At Baseline and 6 months||||mm||Standard Deviation|Mean
1373875|NCT01521949|Secondary|Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline|Doubling time of PSA is the time that it takes for PSA to increase by 100%. Doubling time was calculated prior to starting study treatment and after starting study treatment.|Two years|Intention to treat population|||Participants|||Count of Participants
1373876|NCT01521949|Primary|PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline|PSA will be obtained at baseline, every 6 weeks for the first 6 months, then every 3 months thereafter.|Two years|Intention to treat population|||Participants|||Count of Participants
1375391|NCT01505764|Secondary|Quality of Life.|Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
1373878|NCT01521923|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|The Arthritis interference in the last month with household productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373879|NCT01521923|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days missed of family/social/leisure activities in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
1373880|NCT01521923|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with hired outside help days in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
1373881|NCT01521923|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with reduced household work productivity in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
1373882|NCT01521923|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with no household work in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2."|||days||Standard Deviation|Mean
1373883|NCT01521923|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.~Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373884|NCT01521923|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"Number of work days with reduced productivity in the last month for employed subjects.~Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
1373885|NCT01521923|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of work days missed in the last month for employed subjects.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
1373886|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2|BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue), whereas the score for each dimension is different due to the varied number of questions (0 –22 for physical, 0- 21 for living, 0- 15 for cognition, and 0- 12 for emotion). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373887|NCT01521923|Secondary|Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"Time to flare, defined as an increase of DAS28[ESR] >= 0.6 above Week 52 DAS28[ESR] level, having a DAS28[ESR] >= 3.2 and judged by the Investigator as due to RA and all three criteria confirmed at an additional visit two weeks thereafter, from Week 52 onwards.~Data not available as > 75% of the participants failed to meet flare criteria."|Week 104 in RA0055 Period 2|"FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||days||Geometric Coefficient of Variation|Geometric Mean
1375392|NCT01505764|Secondary|Body Weight.|percent change from day 84-baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
1373888|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373889|NCT01521923|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2|"Normative physical function is defined as HAQ-DI score <= 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373890|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373891|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373892|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.A negative value in CDAI change from Baseline indicates an improvement from Baseline.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373893|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.~A negative value in CDAI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373894|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.~A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373895|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.~A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
1373896|NCT01521923|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2|"Good response is defined as:~DAS28[ESR] <= 3.2 and decrease from Baseline by >1.2;~moderate response is defined as achievement of one of the following:~DAS28[ESR] <= 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28[ESR] > 5.1 and decrease from Baseline >1.2.~LOCF= Last Observation Carried Forward"|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373897|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:~Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1 and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373898|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373899|NCT01521923|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373900|NCT01521923|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373901|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2|"The ACR/EULAR 2011 remission criteria is defined as:~Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1, C-Reactive Protein (CRP) <= 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373916|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccines|Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
1373902|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2|The assessments are based on a 70 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373903|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2|The assessments are based on a 50 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373904|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2|The assessments are based on a 20 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373905|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
1373906|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
1373907|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
1373917|NCT01521897|Other Pre-specified|Number of Participants by Vaccination Sites at Each Vaccination Time|Number of participants was counted by vaccination sites at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
1373908|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
1373909|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.~Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||percentage of subjects|||Number
1373910|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.~Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||percentage of subjects|||Number
1373911|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
1373912|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
1373913|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|Full Analysis Set Period 2 (FAS2) with Non-Responder Imputation (NRI). FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.|||percentage of subjects|||Number
1373914|NCT01521923|Primary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring|This Outcome Measure includes all subjects that have a DAS28 [ESR] <= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
1373915|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccination Sites|Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
1373918|NCT01521897|Other Pre-specified|Number of Participants by Month of Age at Each Vaccination Time|Number of participants was counted by month of age at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
1373919|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
1373920|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
1373921|NCT01521897|Secondary|Number of Participants With Injection Site Reactions|Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for “injection site erythema”; induration for “injection site erythema” and “injection site swelling”; tenderness for ”injection site pain”; and warmth for “injection site warmth”.|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
1373922|NCT01521897|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
1373923|NCT01521897|Primary|Number of Participants With Adverse Reactions|An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
1373924|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated. DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||correlation coefficient|||Number
1373925|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated. DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||correlation coefficient|||Number
1373926|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||correlation coefficient|||Number
1373927|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)|Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.|Baseline, Month 6,1 2, 18, 24|ITT population, Here “n” = participants evaluable for this measure for specified component score and “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||correlation coefficient|||Number
1373928|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated. AIMS2 : 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||correlation coefficient|||Number
1373929|NCT01521884|Secondary|Health Assessment Questionnaire (HAQ) Total Score|HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of item scores. HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
1373930|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
1373931|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)|DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score=more disease activity (DA). DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
1373932|NCT01521884|Secondary|Visual Analog Scale (VAS) Fatigue Score|Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
1373933|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
1373969|NCT01521546|Primary|12-month Change in Myocardial Strain|a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline.|baseline and 12 months||||percent change in heart dimension||Inter-Quartile Range|Median
1373934|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 18|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
1373935|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 12|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
1373936|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 6|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
1373937|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Baseline|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
1373938|NCT01521871|Primary|Patients´Self Satisfaction.|"The patients` self-satisfaction was evaluated by means of a questionnaire rating the following 3 domains on a numerical (1-5) scale:~Total satisfaction regarding wound healing/wound care. 1 (satisfied) to 5 (dissatisfied)~Satisfaction regarding wound discomfort; pain, itching, paresthesia, pressure etc. 1 (almost no discomfort) to 5 (lot of discomfort)~Satisfaction regarding wound care; suppleness, practicability versus mobilization, showering etc. 1 (almost no practical challenges) to 5 (lot of practical challenges)~Patients' Self Satisfaction score was the sum of three domains, ranges from 3 (completely satisfied) to 15 (completely dissatisfied).~These data were collected at the day of discharge, with guidance from two interviewers."|These data were collected at the day of discharge from hospital (postoperative day 4-8).||||units on a scale||Standard Deviation|Mean
1373939|NCT01521871|Primary|TIme Consumption|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.||||minutes||Standard Deviation|Mean
1373940|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
1373982|NCT01521260|Secondary|Complications and Adverse Events||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1373941|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4||||units on a scale||Standard Deviation|Mean
1373942|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2||||units on a scale||Standard Deviation|Mean
1373943|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
1373944|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)||||units on a scale||Standard Deviation|Mean
1373945|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 2 (2 days after kidney donation)||||units on a scale||Standard Deviation|Mean
1373946|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
1373947|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4||||units on a scale||Standard Deviation|Mean
1373948|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2||||units on a scale||Standard Deviation|Mean
1373949|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
1373950|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4||||units on a scale||Standard Deviation|Mean
1373951|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2||||units on a scale||Standard Deviation|Mean
1373952|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
1373953|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)||||units on a scale||Standard Deviation|Mean
1373983|NCT01521260|Secondary|Implant Failure|defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection|baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1373984|NCT01521260|Secondary|Marginal Soft Tissue Recession||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1373954|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for rubor (0–3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postoperative day 2 (2 days after kidney donation)||||units on a scale||Standard Deviation|Mean
1373955|NCT01521845|Secondary|MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death||30 days||||participants|||Number
1373956|NCT01521845|Primary|Inflammation Marker (CRP)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention||||mg/l||Inter-Quartile Range|Median
1373957|NCT01521845|Primary|Cardiac Necrosis Biomarkers (CKMB, Troponin I)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention||||ng/ml||Inter-Quartile Range|Median
1373958|NCT01521780|Secondary|Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.|Resected tumors and adjacent tissues were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for LDL-R protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
1373959|NCT01521780|Secondary|Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
1373960|NCT01521780|Secondary|Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin mRNA by qRT-PCR.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
1373961|NCT01521780|Secondary|Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to derive a Median ADC for each tumor. The mean of the Median ADCs is presented based on tumours as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only eight of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.|||um^2/s|Participants|Standard Deviation|Mean
1373962|NCT01521780|Secondary|Tumor Volumes From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to determine the volume of each tumor. The mean of log tumor volume is presented, based on tumors as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only ten of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.|||log cm^3|Participants|Standard Deviation|Mean
1373963|NCT01521780|Primary|Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
1373964|NCT01521780|Primary|Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
1373965|NCT01521559|Secondary|Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline to week 24|FAS|||scores on a scale||Standard Deviation|Mean
1373966|NCT01521559|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF|CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).|Baseline to week 24|FAS|||microns||Standard Deviation|Mean
1373967|NCT01521559|Secondary|Change From Baseline to Week 24 in BCVA Score - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to Week 24|FAS|||letters correctly read||Standard Deviation|Mean
1373968|NCT01521559|Primary|Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to week 24|FAS|||participants|||Number
1373985|NCT01521260|Secondary|Presence of Calculus||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
1373970|NCT01521507|Secondary|Stage 2 Mean Total OSDI Score at 12 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. Frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. The total OSDI score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat (All participants who received at least a partial LipiFlow treatment or Crossover LipiFlow treatment and had data available at 12 Months). The Two LipiFlow treatments subgroup was not analyzed because the sample size (n<5) was too small for meaningful analysis.|||units on a scale||95% Confidence Interval|Mean
1373971|NCT01521507|Secondary|Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. To be eligible for the study, the Baseline total OSDI score must have been 13 points or higher in each eye. Change=3 Months score-Baseline score.|Baseline, 3 Months|Intent to Treat Population (All participants who were randomized and received at least partial device treatment or used warm compress at least once and had data available at 3 Months).|||units on a scale||95% Confidence Interval|Mean
1373972|NCT01521507|Primary|Stage 2 Mean Total Meibomian Gland Score at 12 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat Population (All participants who received at least partial LipiFlow or Crossover LipiFlow treatment and had data available at 12 Months). Two LipiFlow treatments subgroup was not analyzed because sample size was too small (n<5) for meaningful analysis.|||units on a scale||95% Confidence Interval|Mean
1373973|NCT01521507|Primary|Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.|Baseline and 3 Months|Intent to Treat Population (All Participants who were randomized and received at least partial LipiFlow treatment or used warm compress therapy at least once and had data available at 3 Months).|||units on a scale||95% Confidence Interval|Mean
1373974|NCT01521494|Secondary|Change From Baseline in Serum Intact-PTH Concentrations.||6 weeks|Some patients were excluded from analysis because they failed to have primary endpoint or missed to measure intact-PTH at the end of treatment.|||pg/mL||Standard Deviation|Mean
1373975|NCT01521494|Secondary|Change From Baseline in Serum Calcium Concentrations.||6 weeks|Total of 5 patients were excluded from analysis because they failed to have primary endpoint.|||mg/dL||Standard Deviation|Mean
1373976|NCT01521494|Primary|Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.|Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.|6 weeks|Total of 5 patients were excluded from analysis because they failed to have primary endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
1373977|NCT01521364|Secondary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Saliva.|The data will be used to clinically validate the analysis linezolid in saliva as surrogate marker for linezolid in plasma.|At week 3 (after co-administration of 250mg clarithromycin)|||||||
1373978|NCT01521364|Secondary|Pharmacokinetic Parameters, e.g. Tmax, T1/2, Cmax, Cmin, Cl, of Anti-TB Drugs That Are Co-administered as Part of the Continued Standard Care.||At week 1 (baseline), week 3 (250mg clarithromycin) and week 5 (500mg clarithromycin)|||||||
1373979|NCT01521364|Secondary|Number of Patients With Adverse Events (AEs)|To assess short-term safety and tolerability when combining linezolid (LIN) with clarithromycin (CLA) by monitoring AEs, i.e. gastro-intestinal effects, hyperlactatemia, haematological abnormalities and neuropathy.|Up to week 6|No serious adverse events|||participants|||Number
1373980|NCT01521364|Secondary|Linezolid (LIN) and Clarithromycin (CLA) Pharmacokinetic Parameters, e.g. Tmax, Cmax, Cmin, T1/2, Cl.||At week 1 (baseline), week 3 (250mg clarithromycin), and week 5 (500mg clarithromycin) and week 6 (baseline).|||||||
1373981|NCT01521364|Primary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Plasma After Addition of 0mg, 250mg, or 500mg Clarithromycin (CLA).|"The AUCs of linezolid will be measured at 3 time points after addition of 3 different clarithromycin dosages.~Samples were obtained before doseing and 1h, 2h, 3h, 4h, 8h, and 12h after administration of linezolid (and claritromycin depending on the period)."|At week 1 (baseline), week 3 (250mg clarithromycin), and week 5(500mg clarithromycin).||||mg*h/L||Inter-Quartile Range|Median
1373992|NCT01521260|Primary|Change in Total Bacterial Load on the Exposed Implant Surface|Total bacterial load as obtained by sweeping a microbrush across the implant surface after flap deflection. Samples are obtained immediately after flap deflection and granulation tissue removal AND after the decontamination procedure (mechanical debridement, rinsing of the implant surface using the placebo or chlorhexidine solution, saline rinsing) but before flap closure. The log-transformed mean change in bacterial load is calculated (difference between the two time points --> difference in sample BEFORE decontamination and AFTER decontamination procedure).|During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.||||log (colony forming units/ml)|Participants|Standard Deviation|Log Mean
1373993|NCT01521143|Secondary|Part B - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
1373994|NCT01521143|Secondary|Part B - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
1373995|NCT01521143|Secondary|Part B - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
1373996|NCT01521143|Secondary|Part A - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
1373997|NCT01521143|Secondary|Part A - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
1373998|NCT01521143|Primary|Part A - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
1373999|NCT01521026|Secondary|Hopkins Verbal Learning Test Percent Retained|"Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial.~Score ranges from 0-100. Higher scores represent better performance."|3 months||||units on a scale||Standard Deviation|Mean
1374000|NCT01521026|Primary|UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)|Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.|3 months||||units on a scale||Standard Deviation|Mean
1374001|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||hours||Full Range|Median
1374002|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|"Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose"|Day 1||||hours||Full Range|Median
1374003|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)|"AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||ng.h/mL||Standard Deviation|Mean
1374103|NCT01519960|Secondary|Quantitative HBsAg Level in Groups A and B|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
1374004|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)|AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose|Day 1||||ng.h/mL||Standard Deviation|Mean
1374005|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10)|"AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||ng.h/mL||Standard Deviation|Mean
1374006|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1)|"AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose."|Day 1||||ng.h/mL||Standard Deviation|Mean
1374007|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||ng/mL||Standard Deviation|Mean
1374008|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.|Day 1||||ng/mL||Standard Deviation|Mean
1374009|NCT01520922|Secondary|Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR)|An Infusion reaction is defined as events occurring after the beginning of an infusion of ofatumumab or within 24 hours following the end of an infusion of bendamustine.|From the first dose of study medication to 60 days after the last dose of study medication (up to 24 hours after last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.|||Participants|||Number
1374010|NCT01520922|Secondary|Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|ZAP-70 is a protein normally expressed near the surface membrane of T cells and natural killer cells. ZAP-70 in B cells is used as a prognostic marker in identifying different forms of CLL. Participants with ZAP-70 testing results intermediate (Int), positive (Pos) and negative (Neg) at Baseline and who had a clinical response after last dose of study treatment are provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374011|NCT01520922|Secondary|Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Participants with IgVH mutation results as mutated and unmutated status and clinical response after last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374012|NCT01520922|Secondary|Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment|Participants with B2M concentration of <=4000 µg/L and >4000 µg/L at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374079|NCT01520532|Primary|New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.|An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.|Within 1-3 days post ablation|All subject who underwent an ablation and post-procedure MRI.|||participants|||Number
1374013|NCT01520922|Secondary|Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Cytogenetics refers to the study of numerical and structural chromosomal abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization [FISH]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374014|NCT01520922|Secondary|Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver)|Organomegaly is the abnormal enlargement of organs. Physical examination of the liver (L) and spleen (S) were done at Screening (SCR), C3D1, C6D1, 12-Month F/U, 24-Month F/U and 36-Month F/U. The result of the physical examination of the liver (L) and spleen (S) was presented as normal (NOR), enlarged (EL) and not assessed (NOA).|Screening (Scr), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 -Month Follow-Up (F/U)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374015|NCT01520922|Secondary|Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline|Lymph nodes were evaluated by physical examination which involved recording the diameter in two planes (sum of the product of the diameter [SPD]) of the largest palpable node in each of the following sites: cervical, axillary, supraclavicular, inguinal and femoral. Lymphadenopathy is defined as lymph nodes with the largest diameter greater than 1.5 centimeters. The maximum reduction in SPD from Baseline at C2D1, C3D1, C4D1, C5D1, C6D1, 3-Month F/U, 6-Month F/U and 9-Month F/U are provided.|Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), 3-Month Follow-Up (F/U), 6-Month F/U and 9-Month F/U|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||cm^2 (centimeters squared)||Standard Deviation|Mean
1374016|NCT01520922|Secondary|Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (C Neg) results.|Cycle 1 Day 1 (C1D1), Cycle 6 Day 1 (C6D1), 6-Month Follow-up (F/U), and any post-dose time point|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374017|NCT01520922|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline (BL), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 month follow up (F/U)|Safety Population. All subjects who receive at least one dose of study medication.. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374018|NCT01520922|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms|Participants with the indicated constitutional or B-symptoms (night sweats, weight loss, fever or extreme fatigue) were presented for different time points.|Screening (SCR), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 Month Follow-up (F/U)|Safety Population: All subjects who receive at least one dose of study medication. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1374019|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Event of Infection|Participants with the indicated Grade 3 or Grade 4 adverse event of infection are presented. AEs were graded according to the NCI CTCAE grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: All subjects who receive at least one dose of study medication.|||Participants|||Number
1374020|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication|Safety Population|||Participants|||Number
1374080|NCT01520506|Secondary|Renal Denervation Procedure Effectiveness|Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline|From baseline to 6 months||||percentage of participants|||Number
1374021|NCT01520922|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population All subjects who receive at least one dose of study medication.|||Participants|||Number
1374022|NCT01520922|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.|||Participants|||Number
1374023|NCT01520922|Secondary|Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the partcipants who were suspected of achieving a primary endpoint CR. Analysis of CD5+ CD19+ was performed on the bone marrow aspirate sample obtained no sooner than 2 months following the last dose of study treatment. MRD results were reported as negative or positive. The absence of MRD (negative MRD) is defined as less than one CLL cell per 10000 leukocytes.|3 month follow up to the 36 Month Follow-up (in 3 month interval)|ATS Population. Number of subjects who had CR with bone marrow confirmation are included. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
1374024|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months|CD5-CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5- CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Cell per microliter||Standard Deviation|Mean
1374025|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months|CD5+ CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+ CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Cell per microliter||Standard Deviation|Mean
1374026|NCT01520922|Secondary|Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and end of study treatment (up to 30 months)|Safety Population. Only those participants who were available at the indicated time points were analyzed.|||Gram per liter||Standard Deviation|Mean
1374027|NCT01520922|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: all participants who received at least one dose of any study treatment (ofatumumab or bendamustine).|||Participants|||Number
1374028|NCT01520922|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from the date of the first administration of study treatment until the start of the next anti-CLL therapy.|From the start of study treatment until the start of the next anti-CLL therapy (up to 3 years after the last dose of study treatment)|ATS Population. Only participants that took anti-CLL therapy were evaluated.|||Months||95% Confidence Interval|Median
1374029|NCT01520922|Secondary|Investigator-Assessed Kaplan-Meier Estimates of Time to Progression|Time to progression is defined as the time from the date of the first administration of study treatment to disease progression (PD). PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000 B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From the start of study treatment to disease progression (up to 3 years after the last dose of study treatment)|All treated subjects (ATS). This analysis includes patients who had progression.|||Months||95% Confidence Interval|Median
1374030|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Overall Survival|OS is defined as the interval of time between the date of the first administration of study treatment and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From the start of study treatment to the date of death due to any cause (up to 3 years after the last dose of study treatment)|All treated subjects. N= Death|||Months||95% Confidence Interval|Median
1374031|NCT01520922|Secondary|Investigator-assessed of Kaplan-meier Estimates of Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of the first administration of study treatment and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following:new lesion or increase by >=50% from BL in LC, Ly, size of liver and spleen, PL >= 50% decrease from BL, or to <100,000/uL secondary to CLL, Hb decrease of >2 g/dL from BL or to <10 g/dL secondary to CLL, CLL- transformation. Response was determined according to the IWCLL updated NCI-WG guidelines 2008. Participants who have neither progressed or died at the time of analysis were censored at the date of the last adequate assessment. If there was more than 1 scheduled visit missed, PFS is censored at the last adequate assessment of response. An adequate assessment is defined as an assessment where the investigator determined a response of CR, CRi, nPR, PR, or stable disease (SD).|From the start of study treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|All Treated Subjects’ (ATS) population. N= Progression or Death|||Months||95% Confidence Interval|Median
1374032|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Duration of Response|The duration of response is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of disease progression (PD) or death due to any cause. PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From time of initial response (CR, CRi, nPR, or PR) to disease progression or death, whichever came first (up to 3 years after the last doseof study treatment)|ATS Population. Only participants with an initial response (CR, CRi, nPR, or PR) with PD or death were assessed for duration of response.|||Months||95% Confidence Interval|Median
1374033|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Time to Response|Time to response is defined as time from date of the first administration of study treatment to the first response (CR, CRi, nPR, or PR). Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR: all of the following criteria at least 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/ thrombocytopenia/ neutropenia unrelated to CLL but related to drug toxicity. nPR: persistent nodules BM. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11.0 g/dL or 50% improvement over BL, LC <4000/µL.|From the start of study treatment to the first response (CR, CRi, nPR, or PR) (up to 3 Month Follow-up (F/U) visit)|ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.|||Months||95% Confidence Interval|Median
1374034|NCT01520922|Secondary|Number of Participants With Complete Response (CR) With and Without a CT Scan Assessment After the Last Dose of Study Treatment, as Assessed by the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500/µL, platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 g/dL, lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population|||Participants|||Number
1374035|NCT01520922|Secondary|Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population. OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.|||Participants|||Number
1374036|NCT01520922|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|As-treated subjects (ATS) Population: all participants who received at least one dose of both study drugs (ofatumumab and bendamustine). OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.|||Participants|||Number
1374081|NCT01520506|Secondary|Chronic Procedural Safety|Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months|6 months||||percentage of participants|||Number
1374037|NCT01520909|Secondary|Population PK Model Point Estimate for Eltrombopag for Absorption Rate-constant (Ka)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Ka is defined as the absorption rate constant. This parameter is dose independent, and the population estimate Ka is reported.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||1/h|||Number
1374038|NCT01520909|Secondary|PK Assessments for Eltrombopag for Apparent Central Volume (Vc/F) and Apparent Peripheral Volume (Vp/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Vc/F is defined as the volume of the central (e.g. plasma) compartment and Vp/F is defined as the volume of the peripheral compartment. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||Liters (L)||95% Confidence Interval|Geometric Mean
1374039|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Oral Clearance (CL/F) and Apparent Intercompartmental Clearance (Q/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
1374040|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Cmax is defined as the maximum observed concentration. The Cmax for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
1374041|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for AUC (0-t)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. The AUC(0-t) for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||micrograms*hour per milliliter (ug.h/mL)||95% Confidence Interval|Geometric Mean
1374042|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Follow-Up Week 24|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Follow-up Week 24 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Follow-Up Week 24 (Week 61)|Safety Population. Only those participants who had worsening visual acuity at Week 61 were analyzed.|||Participants|||Number
1374043|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 24 of Part 2|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 24 of Part 2 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 24 of Part 2|Safety Population. Only those participants who had worsening visual acuity at Week 24 were analyzed.|||Participants|||Number
1374044|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 12 of Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 12 of Part 1 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 12 of Part 1|Safety Population. Only those participants who had a result of ‘worsening’ in assessment of change of visual acuity at this timepoint were analyzed.|||Participants|||Number
1374045|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Follow-Up Week 24|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Follow-Up Week 24 (Study Week 61)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
1374082|NCT01520506|Primary|Acute Procedural Safety|"Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:~SAE's related to groin and vascular access complications, and~SAE's related to renal artery injury."|One Week||||percentage of participants|||Number
1374046|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 24 of Part 2|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 24 of Part 2|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
1374047|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 12 of Part 1|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No (no change from Baseline), Not Clinically Significant (NCS), Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 12 of Part 1|Safety Population|||Participants|||Number
1374048|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 2|Vital sign measurements were taken before any blood draw and included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard RR as reference range high(RRH) and reference range low(RRL) from SCR up to Week 24 of Part 2 and from Follow-up Week 1 to Week 4. RR for Blood Pressure(mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120; DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR (bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Week 1 up to Week 24 of Part 2 and Follow-up Week 1 to Week 4 (up to Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
1374049|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 1|Vital sign measurements were taken before any blood draws and included systolic blood pressure(SBP), diastolic blood pressure(DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard reference ranges RR as reference range high(RRH) and reference range low(RRL). The Baseline(BL) value is defined as the value taken at Day 1 or if missing, the latest non-missing SCR value. RR for Blood Pressure (mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120;, DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR(bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Screening (SCR) up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
1374050|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 2|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none, G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline up to Week 24 of Part 2 and Follow-up Weeks 1 to 4 (up to Study Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
1374051|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 1|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
1374052|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 2|Clinical chemistry parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: AST, ALP, total bilirubin, albumin, ALT, and creatinine. For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For serum creatinine, the value taken at Week 13 of Part 1 will be used as BL. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as BL. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline (BL) of Part 2 through Follow-up|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
1375393|NCT01505764|Secondary|Muscle Strength as Measured by Grip Strength.|Dominant hand grip strength day 84 - percent change from baseline|day 84|Cancer cachexia patients|||percentage change||Standard Deviation|Mean
1374053|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 1|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: Grade 0 (G0), none; Grade 1 (G1), mild; Grade 2 (G2), moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling. Clinical chemistry parameters included: aspartate amino transferase (AST), alkaline phosphatase (ALP), total bilirubin, albumin, alanine amino transferase (ALT), prothrombin international normalized ratio (PT INR), activated partial thromboplastin time (APTT), and creatinine. The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as Baseline. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
1374054|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening; requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Part 2 up to Week 24 of Part 2 + 1 day|Safety Population|||Participants|||Number
1374055|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Treatment up to Week 13 of Part 1+ 1 day|Safety Population: all participants who received at least one dose of the investigational product|||Participants|||Number
1374056|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the WHO Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO Grades were dichotomized into the following categories: no bleeding = Grade 0; any bleeding = Grade 1 to 4; no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4.|From Baseline of Part 2 through Follow-up|ITT Population. Only those participants who entered into Part 2 open-label Eltrombopag only phase were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
1374057|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
1374058|NCT01520909|Secondary|Number of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During Part 2 Without Requiring Subsequent Rescue Therapy|Participants who discontinued or had a sustained reduction of a baseline immune (idiopathic) thrombocytopenic purpura (ITP) medication during the 24 weeks of Part 2 (Open-Label Period) and without requiring subsequent rescue therapy. For participants randomized to placebo in Part 1, Baseline is defined as Week 13 of Part 1. For participants randomized to eltrombopag in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction was defined as a reduction for 4 weeks or more.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) and taking an ITP medication at Baseline were analyzed.|||Participants|||Number
1374059|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During Part 2|The maximum duration for which a participant continuously maintained a platelet count of >=50 Gi/L was calculated and summarized for the 24 weeks of eltrombopag dosing (Part 2). Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Weeks||Standard Deviation|Mean
1374060|NCT01520909|Secondary|Number of Weeks in Which Participants Achieved a Platelet Count >=50 Gi/L, Between Weeks 4 and 24 of Part 2|Platelet response was analyzed after Week 4 for the eltrombopag-only period to allow participants who had been randomized to placebo in the Randomized Period time to escalate to their optimal dose of eltrombopag. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Week 4 up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Weeks||Standard Deviation|Mean
1374061|NCT01520909|Secondary|Number of Participants Who Achieved a Platelet Count >=50 Gi/L at Any Time During Part 2|Participants who achieved a platelet count >=50 Gi/L at any time during Part 2 (up to Week 24) were reported.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
1375394|NCT01505764|Secondary|Lean Mass Measured by Densitometry.|lean body mass measured by DEXA. Percentage of change day 84-baseline.|day 84|only two subjects in each group completed this measure.|||percentage change||Standard Deviation|Mean
1374062|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 1|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline was defined as the Day 1 assessment or the latest possible screening assessment.|From Baseline through Follow-up of Part 1|ITT Population. Only those participants that did not enroll in Part 2 were analyzed during the follow-up visits. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
1374063|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1|Rescue treatment is defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 12 of Part 1|ITT Population|||Participants|||Number
1374064|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the First 12 Weeks of Part 1|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L was calculated and summarized for the first 12 weeks of Part 1. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 12 of Part 1|ITT Population|||Weeks||Standard Deviation|Mean
1374065|NCT01520909|Secondary|Weighted Mean Platelet Count|"The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the study (12 weeks). Weighted mean platelet counts from baseline to week 12 of the randomized period was compared between placebo and eltrombopag using an analysis of covariance model (ANCOVA) adjusting for baseline platelet count and age cohort. For each subject the area between two adjacent visits with platelet counts was calculated. The area was calculated for all pairs of adjacent visits starting at Day 1 of randomized period and then the total sum of all the areas was divided by the total duration of time during the randomized period. For each subject, this method calculates an ‘average’ platelet count and it allows the possibility that subjects may have had different number of assessments during different times relative to baseline."|Baseline and Week 12 of Part 1|ITT Population. Only those participants with a value at Baseline and post-Baseline were analyzed.|||Gi/L||Standard Deviation|Mean
1374066|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 6 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 6 weeks of Part 1 were reported.|From Baseline up to Week 6 of Part 1|ITT Population|||Participants|||Number
1374067|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 12 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 12 weeks of Part 1 were reported.|From Baseline up to Week 12 of Part 1|ITT Population|||Participants|||Number
1374068|NCT01520909|Secondary|Percentage of Responders|Percentage of participants who responded (defined as platelet count >= 50 Gi/L in absence of rescue) at least once up to week 12 of Part 1 (Odds of achieving a platelet count >=50 Gi/L during the first 12 weeks of Part 1)|From Week 1 up to Week 12 of Part 1|ITT Population|||Percentage of participants|||Number
1374069|NCT01520909|Primary|Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1|Participants who achieved a platelet count >=50 Gi/L for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1, were reported.|From Week 5 up to Week 12 of Part 1|Intent-to-Treat (ITT) Population: all randomized participants. The ITT Population was the primary population used for assessing efficacy.|||Participants|||Number
1374070|NCT01520727|Secondary|Time to Cmax (Tmax)||pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose||||hours||Full Range|Median
1374071|NCT01520727|Secondary|Cmax - BIA 9-1067|Cmax - maximum plasma concentration|pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose||||ng/mL||Standard Deviation|Mean
1374072|NCT01520727|Primary|Adverse Events (AEs)|Safety was evaluated from the number of reported adverse events (AEs)|7 weeks||||Number of Adverse Events|||Number
1374073|NCT01520714|Primary|Evidence of Change in Threshold of >1 Volt With Posture Changes||6 months|Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.||||||
1374074|NCT01520558|Secondary|Efficacy|Determine relapse free survival (RFS) and overall survival (OS) following infusion with CNDO-109-Activated Allogeneic Natural Killer Cells.|from the date of documented CR until the first documented progression date or until day 360 post dose whichever is sooner|||||||
1374075|NCT01520558|Secondary|Additional Safety Profile Beyond MTD|Characterize the safety profile of CNDO-109-Activated Allogeneic Natural Killer Cells infusion after preparative therapy by measurement of adverse events, safety labs, vital signs, bone marrow biopsy/aspiration and physical examination.|up to 360 days post dose|||||||
1374076|NCT01520558|Primary|Define MTD|The primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence. The MTD outcome measure is presented as number of participants with DLTs.|up to 30 days post dose||||Participants|||Count of Participants
1374077|NCT01520532|Secondary|Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.|The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.|Day 1 (End of Procedure)|All subjects who underwent ablation and post-procedure MRI.|||participants|||Number
1375395|NCT01505764|Primary|Total Body Potassium.|percentage change from baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
1374083|NCT01520454|Secondary|Phosphorylation of STAT3 Pathways Downstream of Leptin After Lipid Administration|Intracellular signaling mechanisms downstream of leptin (particularly the STAT3 pathway) in response to lipid administration as represented by phosphorylation (pSTAT3).|Baseline to 6 hours|The analysis unfortunately can not be performed due to technical reasons as STAT3 was not able to be measured in the samples/not enough volume was left to perform the appropriate tests after trouble-shooting.||||||
1374084|NCT01520454|Secondary|Change in Circulating Adiponectin Levels|The Adiponectin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||ng*min/ml||Standard Deviation|Mean
1374085|NCT01520454|Secondary|Change in Circulating Leptin Levels|The Leptin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||ng*min/ml||Standard Deviation|Mean
1374086|NCT01520454|Secondary|Change in Circulating Insulin Levels|The Insulin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||mU*min/ml||Standard Deviation|Mean
1374087|NCT01520454|Secondary|Change in Circulating Glucose Levels|The Glucose AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||mg*min/dl||Standard Deviation|Mean
1374088|NCT01520454|Primary|Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels|The PYY AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pg*min/ml||Standard Deviation|Mean
1374089|NCT01520454|Primary|Change in Circulating Ghrelin Levels|The Ghrelin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pg*min/ml||Standard Deviation|Mean
1374090|NCT01520454|Primary|Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels|The GIP AUC fwas calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pM*min/ml||Standard Deviation|Mean
1374091|NCT01520454|Primary|Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels|The GLP-1 area under the curve (AUC) was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pM*min||Standard Deviation|Mean
1374092|NCT01520402|Primary|Median Cumulative Warfarin Dose Requirement by Genotype Category (CYP2C9 and VKORC1 -1639 G>A Combination)|Subjects were also grouped into four categories based on CYP2C9 and VKORC1 genotype profile: Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant). Median cumulative warfarin dose requirement was determined for each genotype category.|2-30 days|Of the 35 subjects enrolled, 30 were included in the study as above.|||milligrams||Inter-Quartile Range|Median
1374093|NCT01520402|Secondary|Explained Variation in Combined Therapeutic Warfarin Dose Models|The proportion of variance (R^2) explained by each predictor was calculated using multivariate regression analysis and adjusted for age, gender and reported race, with outcome values logarithmically transformed. The study was powered to detect R^2 > 20%, and significance was accepted at p<0.05.|average of 2 - 30 days|Of the 35 subjects enrolled, 30 completed the study as described above.|||proportion of variance|||Number
1374094|NCT01520402|Secondary|Median Cumulative Warfarin Dose Requirements by CYP4F2 Genotype Status|To assess the effect of CYP4F2 genotype variants on the anticoagulant response to warfarin.|average of 2 - 30 days|Of 35 subjects were enrolled, 30 were included as listed above.|||milligrams||Inter-Quartile Range|Median
1374095|NCT01520402|Primary|Median Cumulative Therapeutic Warfarin Dose (Milligrams)Requirements by Genotype|To assess the effect of genotype variants (CYP2C9 and VKORC1 -1639 G>A) on the anticoagulant response to warfarin, the primary outcome was the cumulative dose required to achieve an INR value in the usual clinical therapeutic range (>2.0) for two consecutive days.|average of 2 - 13 days|Of the 35 subjects enrolled, 30 were included in the study as listed above.|||milligrams||Inter-Quartile Range|Median
1374096|NCT01520207|Primary|Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.|SBP decline during first three sessions|First three hemodialysis sessions (5 days)|SBP decline|||mmHg||Standard Deviation|Mean
1374097|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Group C|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.|||log10 IU/mL||Standard Deviation|Mean
1374098|NCT01519960|Secondary|Quantitative HBsAg Level in Group C|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.|||log10 IU/mL||Standard Deviation|Mean
1374099|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Group C|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||log10 PEIU/mL||Standard Deviation|Mean
1374100|NCT01519960|Secondary|Quantitative HBeAg Level in Group C|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 PEIU/mL||Standard Deviation|Mean
1374101|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Group C|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
1374102|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Groups A and B|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||log10 IU/mL||Standard Deviation|Mean
1374104|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Groups A and B|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||log10 PEIU/mL||Standard Deviation|Mean
1374105|NCT01519960|Secondary|Quantitative HBeAg Level in Groups A and B|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL).|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 PEIU/mL||Standard Deviation|Mean
1374106|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Groups A and B|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
1374107|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374108|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||standard deviations||Standard Deviation|Mean
1374109|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|Safety Population.|||standard deviations||Standard Deviation|Mean
1374110|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||standard deviations||Standard Deviation|Mean
1374111|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||standard deviations||Standard Deviation|Mean
1374112|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Group C|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants|||Number
1374113|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Group C|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants|||Number
1374114|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||percentage of participants|||Number
1374115|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||percentage of participants|||Number
1374131|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1375416|NCT01505673|Secondary|Number of Daily Injections|The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month.|6-months||||number/day||Standard Deviation|Mean
1374116|NCT01519960|Secondary|Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category|AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL).|Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)|"PK Substudy Population: All participants who consented to participate in the PK substudy. The Number of Participants Analyzed reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table."|||h*ng/mL||Full Range|Mean
1374117|NCT01519960|Secondary|Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C|Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis.|Baseline; Week 48; FU Week 24 (up to 72 weeks overall)|"Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||kPa||Standard Deviation|Mean
1374118|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Group C|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
1374119|NCT01519960|Secondary|Quantitative HBV DNA Level in Group C|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
1374120|NCT01519960|Secondary|Quantitative Serum ALT Level in Group C|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
1374121|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374122|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374123|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374124|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374125|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374126|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374127|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT in Group C|The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374128|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374129|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT in Group C|The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374130|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374132|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374133|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374134|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374135|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374136|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374137|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374138|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1374139|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.|||percentage of participants||95% Confidence Interval|Number
1374140|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Groups A and B|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
1374141|NCT01519960|Secondary|Quantitative HBV DNA Level in Groups A and B|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
1374142|NCT01519960|Secondary|Quantitative Serum ALT Level in Groups A and B|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
1374143|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374144|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374145|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374146|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374147|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374148|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT/POP in Groups A and B|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374149|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374150|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374151|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374152|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374153|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374154|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374155|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374156|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374157|NCT01519960|Secondary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374158|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B|Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374159|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374160|NCT01519960|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374161|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1374162|NCT01519960|Primary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.|||percentage of participants||95% Confidence Interval|Number
1374163|NCT01519934|Secondary|Patient Satisfaction|Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.|180 days post-treatment||||percentage of participants|||Number
1374164|NCT01519934|Secondary|Subject Perception of Age|"Percentage of subjects rated as looking younger as measured using a Subject Perception of Age questionnaire."|Baseline to 180 days post-treatment||||percentage of participants|||Number
1374165|NCT01519934|Secondary|Overall Aesthetic Improvement|"Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"|Baseline to 180 days post-treatment||||percentage of participants|||Number
1374166|NCT01519934|Primary|Improvement in Overall Lifting and Tightening of the Skin|Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.|Baseline to 180 days post-treatment||||percentage of participants|||Number
1374167|NCT01519921|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.|Up to Week 72|Safety population included participants who received at least one dose of study medication and who had at least one post-baseline safety assessment.|||Participants|||Number
1374168|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72|A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1374169|NCT01519921|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72|A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1374170|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion|A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1374171|NCT01519921|Secondary|Percentage of Participants With a Combined Response At Week 48 and Week 72|A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1374172|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72|Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1374173|NCT01519921|Secondary|Percentage of Participants With ALT Normalization At Week 48 and Week 72|Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1374174|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72|Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.|Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1374175|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.|Week 72|Intent-to-treat (ITT) population included all participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1374176|NCT01519882|Secondary|Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~The number of turnings in bed was determined via a postural sensor placed on the subject’s chest."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||Number of turnings in bed|||Number
1374177|NCT01519882|Secondary|Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~Sleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by:~(Time in bed (Period between lights off and lights on))-(Sleep time)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||minutes||Standard Deviation|Mean
1374400|NCT01517984|Secondary|Measurement of Urinary Parameters Before and After Randomization|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 months post-transplantation to 18 months post-randomization|No analyses were performed due to early study closure.||||||
1374178|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
1374179|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
1374180|NCT01519882|Secondary|Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~The sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by:~(Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||minutes||Standard Deviation|Mean
1374181|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period|"The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:~0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.~The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
1374182|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period|"The ESS measures the subject’s general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:~0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.~The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
1374183|NCT01519882|Secondary|Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period|"The PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.~Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
1374184|NCT01519882|Secondary|Change From Baseline in the Parkinson’s Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson’s Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.~Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
1374185|NCT01519882|Primary|Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period|"The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between lights off and lights on)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||percentage change||Standard Deviation|Mean
1374186|NCT01519817|Secondary|Changes in Soluble Cluster of Differentiation 40L (sCD40L)|Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||ng/ml||Inter-Quartile Range|Median
1374187|NCT01519817|Secondary|Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)|Blood samples were collected and changes in serum levels of the ratio of soluble sCD27:sCD40L was assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27:sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||Ratio||Inter-Quartile Range|Median
1374328|NCT01519167|Secondary|Number of Subjects Not Receiving Rescue Midazolam|Number of subjects who did not receive any rescue midazolam for sedation during the study drug infusion.|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
1374188|NCT01519817|Secondary|Changes in Soluble Cluster of Differentiation 27 (sCD27)|Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27 was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||U/ml||Inter-Quartile Range|Median
1374189|NCT01519817|Secondary|Changes in Serum Levels of Cytokines|Blood samples were collected and changes in serum levels of cytokines interferon gamma (IFNg), Interleukin 10 (IL-10), Interleukin 12 (IL-12)p70, Interleukin 1b (IL-1b), Interleukin 2 (IL-2), Interleukin 6 (IL-6), Interleukin 8 (IL-8), and tumor necrosis factor (TNF) were assessed by the multiplexed mesoscale assay. Significance of changes in serum levels of cytokines was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||pg/ml||Inter-Quartile Range|Median
1374190|NCT01519817|Secondary|Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)|Blood samples will be collected via apheresis and analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC), Tregs, CD4 central memory (CD4 CM), CD4 effector memory (CD4 EM), CD4 terminal effector memory (CD4 EMRA), CD4 naïve, CD8 CM, CD8 EM, CD8 EMRA, and CD8 naïve cells. Significance of changes in immune cells was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||percentage of PBMC||Inter-Quartile Range|Median
1374191|NCT01519817|Secondary|Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)|Clinical benefit is defined as partial response (PR) or stable disease (SD) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response is ≥30% decrease in the sum of greatest diameters/no new lesions. Progressive disease is ≥20% increase in the sum of greatest diameters/new lesions. Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response, or progressive disease.|3 and 5 months restaging|One participant was not evaluable and came off study due to infection prior to restaging. Two participants were not evaluable due to withdrawal from the study or lack of measurable disease. Three patients with stable disease at 3 months elected to pursue alternate treatment and did not have 5 month restaging.|||Participants|||Count of Participants
1374192|NCT01519817|Primary|Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) Vaccine|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.|4 years and 25 days||||Participants|||Count of Participants
1374193|NCT01519817|Primary|Number of Participants With Brachyury-Specific T-cell Responses|A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.|Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)|Sufficient peripheral blood mononuclear cells (PBMCs) were available before and after vaccination from 31 of 34 patients to analyze brachyury-specific CD4 and CD8 T-cell responses.|||Participants|||Count of Participants
1374194|NCT01519791|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52|LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374195|NCT01519791|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1374196|NCT01519791|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
1374197|NCT01519791|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
1374198|NCT01519791|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
1374199|NCT01519791|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
1374200|NCT01519791|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1374201|NCT01519791|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
1374202|NCT01519791|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
1374203|NCT01519791|Secondary|Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52|"BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).~A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing BRAF-MDQ values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1374204|NCT01519791|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52|"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability.~A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing HAQ-DI values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1374205|NCT01519791|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52|"Normative physical function is defined as HAQ-DI score ≤ 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374206|NCT01519791|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing SDAI values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1374207|NCT01519791|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.~The CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing CDAI values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1374377|NCT01518270|Secondary|Eyelash Thickness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).|Baseline|All participants with values available.|||Millimeters squared (mm^2)||Full Range|Mean
1374208|NCT01519791|Secondary|Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing DAS28(ESR) values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1374209|NCT01519791|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52|"Good response is defined as:~DAS28[ESR] ≤ 3.2 and decrease from Baseline by > 1.2;~moderate response is defined as achievement of one of the following:~DAS28[ESR] ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28[ESR] > 5.1 and decrease from Baseline >1.2."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR).|||percentage of subjects|||Number
1374210|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:~Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374211|NCT01519791|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374212|NCT01519791|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374213|NCT01519791|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374214|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52|"The ACR/EULAR 2011 remission criteria is defined as:~Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374215|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline in the number of tender joints, a 70 %, or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374378|NCT01518270|Primary|Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.|Baseline|All participants with values available.|||Millimeters (mm)||Full Range|Mean
1374401|NCT01517984|Secondary|Incremental Change in IF/TA Scores|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-transplant|No analyses were performed due to early study closure.||||||
1374216|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline in the number of tender joints, a 50 %, or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374217|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374218|NCT01519791|Secondary|Change From Baseline in the Joint Narrowing Score to Week 52|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
1374219|NCT01519791|Secondary|Change From Baseline in the Joint Erosion Score to Week 52|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280."|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
1374220|NCT01519791|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52|Radiographic non-progression is defined as change in mTSS ≤ 0.5.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||percentage of subjects|||Number
1374221|NCT01519791|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
1374222|NCT01519791|Secondary|Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52|Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374223|NCT01519791|Primary|Percentage of Subjects in Sustained Remission at Week 52|"Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.~DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
1374224|NCT01519778|Primary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).|24-31 days|Patients receiving any amount of study drug|||participants|||Number
1374225|NCT01519765|Secondary|Patient Preference|All patients were given a patient satisfaction survey after delivery. They were asked to select their preference for misoprostol intervention type: buccal, vaginal, or either.|Until 72 hours after delivery|All participants were given the survey however incomplete collection was obtained.|||participants|||Number
1374421|NCT01517750|Post-Hoc|Adherence With ENT Surgeries||6 weeks after randomization||||mins||Standard Deviation|Mean
1374422|NCT01517750|Post-Hoc|Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries||6 weeks after randomization||||units on a scale||Standard Deviation|Mean
1374226|NCT01519765|Secondary|Patient Satisfaction With Buccal Versus Vaginal Misoprostol Administration.|"All patients were given a patient satisfaction survey. Patients were asked to use a Likert scale to rate their experience on the following:~Likert sub-scale: 1 to 5~1=Not at all/ Never to 5= Very Much/ Always~Nausea and vomiting 1=better outcome 5=worse outcome~effectiveness of misoprostol 1=worse outcome 5=better outcome~concerns of misoprostol 1=better outcome 5=worse outcome~overall labor experience 1=worse outcome 5=better outcome Patients will be followed for the duration of their labor(usually up to 72hrs). The satisfaction survey will be conducted after delivery but will evaluate side effects that they recollect in labor."|Until 72 hours after delivery|Patient surveys were requested from all participants however incomplete patient survey collection was obtained.|||units on a scale||Full Range|Median
1374227|NCT01519765|Secondary|APGARS|"Median (APGAR) score at 5 minutes after delivery. APGAR: Appearance, Pulse, Grimace, Activity, Respiration Apgar scale is determine by evaluating a newborn on 5 categories on a scale from 0 to 2, then summing up the five values.~Score range is 0 to 10. Score above 7 are generally normal. Score below 3 may indicated poor status."|5 minutes after delivery||||score||Full Range|Median
1374228|NCT01519765|Secondary|Chorioamnionitis|Percentage of participants affected with chorioamnionitis|Until 48 hours after delivery||||percentage of participants||95% Confidence Interval|Number
1374229|NCT01519765|Secondary|Meconium|Percentage of participants who developed meconium was computed. Presence of meconium was evaluated by the delivering physician. P-value was computed using Fisher exact test.|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374230|NCT01519765|Secondary|Neonatal Intensive Care Unit (NICU) Admission|"Percentage of participants whose baby was admitted to NICU was computed from time to delivery to time of hospital discharge.~P-value was computed using Fisher Exact test."|Until discharge from hospital||||percentage of participants||95% Confidence Interval|Number
1374231|NCT01519765|Secondary|Tachysystole|Fetal heart tracing was reviewed until 4 hours after last misoprostol dose. Percentage of participant with tachysystole were computed. Tachysystole was defined as more than five uterine contractions in 10 minutes. P value was computed using Fisher exact test|Until 4 hours after last misoprostol dose||||percentage of participants||95% Confidence Interval|Number
1374232|NCT01519765|Secondary|Tachysystole With Abnormal FHT|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.~Percentage of participants who presented with tachysystole and abnormal fetal heart tracing was computed.~Abnormal fetal heart tracing was defined as category 2 and above. Tachysystole was defined as more than 5 uterine contractions within 10 minutes. P values were computed by Fisher exact test."|Until 4 hours after last misoprostol dose||||percentage of participants||95% Confidence Interval|Number
1374233|NCT01519765|Secondary|Abnormal Fetal Heart Tracing (FHT)|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.~Percentage of participants who presented with abnormal fetal heart tracing was computed.~Abnormal fetal heart tracing was defined as category 2 and 3 fetal heart tracing according to standard criteria.~Abnormal fetal heart tracing included any of the following tachycardia, bradycardia without absent variability, minimal variability, absent variability with or without recurrent decelerations, marked variability, prolonged deceleration and recurrent late deceleration, sinusoidal pattern.~P values were computed by Fisher exact test."|Until 4 hours of last misoprostol dose||||percentage of participants||95% Confidence Interval|Number
1374234|NCT01519765|Secondary|Artificial Rupture of Membranes (AROM)|Percentage of participants that required AROM|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374235|NCT01519765|Secondary|Foley Bulb|Percentage of participants that required foley bulb use.|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374236|NCT01519765|Secondary|Pitocin|Percentage of patients that used pitocin during labor. P-values were computed using Fisher exact test.|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374237|NCT01519765|Secondary|Failed Induction of Labor|"Percentage of participants who were determined as a failed induction of labor. Failed induction was defined as no cervical change despite 24 hours of pitocin or 12 hours of pitocin after rupture of membranes.~P value was computed by Fisher exact test."|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374238|NCT01519765|Secondary|Arrest of Dilation|"Percentage of participants who presented with arrest of dilation. Arrest of dilation was determined by the delivering physician.~P-value was computed using Fisher exact test."|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374239|NCT01519765|Secondary|Number of Misoprostol Doses|Number of misoprostol 25 mcg doses used during induction of labor.|Until delivery||||doses||Full Range|Median
1374240|NCT01519765|Secondary|Cesarean Delivery Rate|Percentage of participants who underwent a cesarean delivery was computed. P-value was computed using Fisher's exact test.|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374241|NCT01519765|Secondary|Rates of Vaginal Delivery|Percentage of participants who delivered vaginally|Until delivery||||percentage of participants||95% Confidence Interval|Number
1374242|NCT01519765|Secondary|Time to Active Labor|Time from induction to active labor. Active labor defined as 4 cm and above. P-value computed by Kruskal-Wallis test.|Until active labor||||hours||Full Range|Median
1374243|NCT01519765|Secondary|Time to Delivery|Time from induction to delivery. All participants were included.|Until delivery||||hours||Full Range|Median
1374244|NCT01519765|Secondary|Time to Vaginal Delivery|Time from start of induction to vaginal delivery was computed in participants who achieved vaginal delivery.|Start of induction until vaginal delivery|Participants who achieved vaginal delivery were included in the analysis|||hours||Full Range|Median
1374245|NCT01519765|Primary|Vaginal Delivery Within 24 Hours of Labor Induction|Percentage of participants able to achieve vaginal delivery within 24 hours of labor induction.|Within 24 hours of labor induction||||percentage of participants||95% Confidence Interval|Number
1374379|NCT01518257|Post-Hoc|Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.|||Score on a scale||Standard Deviation|Mean
1374246|NCT01519713|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.|||Participants|||Number
1374247|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1374248|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|Days 0 and 28 post-vaccination|Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1374249|NCT01519713|Secondary|Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Participants|||Number
1374250|NCT01519713|Secondary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Participants|||Number
1374251|NCT01519713|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Participants|||Number
1374252|NCT01519700|Secondary|Incidence of Hospitalizations Due to Febrile Neutropenia|Incidence of hospitalizations due to Febrile Neutropenia|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.|||participants|||Number
1374253|NCT01519700|Secondary|Frequency of Infections|Frequency of infections by cycle and across all cycles|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups.|||participants|||Number
1374254|NCT01519700|Secondary|Time to Absolute Neutrophil Count Recovery|Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 & Neupogen group, one patient’s time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint.|||Days||Full Range|Median
1374255|NCT01519700|Secondary|Depth of Absolute Neutrophil Count Nadir|Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation|||10^9 cells/L||Standard Deviation|Mean
1374256|NCT01519700|Secondary|Number of Days of Fever|Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.|21 weeks/ 6 cycles|PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations.|||participants|||Number
1374257|NCT01519700|Secondary|Incidence of Febrile Neutropenia|Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)|21 weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.|||participants|||Number
1374258|NCT01519700|Primary|Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)|21 days (Cycle 1 of chemotherapy treatment)|PP population|||Days||Standard Deviation|Mean
1374259|NCT01519674|Secondary|Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.|Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0−100 scale with higher scores indicating greater satisfaction.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 545 subjects contributed to the statistical analysis at Week 24.|||scores||Standard Error|Least Squares Mean
1374504|NCT01516736|Secondary|Number of Patients With ANC Nadir Per Day in Cycle 1|Numbers of patients with ANC nadir based per day during Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
1374260|NCT01519674|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.|Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.|||episodes|||Number
1374261|NCT01519674|Secondary|Adverse Events (AEs)|Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.|||Events/100 years of patient exposure|||Number
1374262|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Overall Mean Increment.|Estimated overall mean post prandial increment after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 557 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
1374263|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Dinner.|Estimated mean post prandial increments at dinner after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 550 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
1374264|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Lunch.|Estimated mean post prandial increments at lunch after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 548 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
1374265|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Breakfast|Estimated mean post prandial increments at breakfast after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 555 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
1374266|NCT01519674|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in fasting plasma glucose (FPG)|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 556 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
1374267|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)|Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.|||percentage (%) of subjects|||Number
1374268|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)|Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.|||percentage (%) of subjects|||Number
1374269|NCT01519674|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 24 weeks of treatment.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1374270|NCT01519661|Secondary|Time to Use of New Anti-pseudomonal Antibiotic|Time to first use of new anti-pseudomonal antibiotic was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1374271|NCT01519661|Secondary|Number of Days of New Anti-pseudomonal Antibiotic Use|The total number of days of new anti-pseudomonal antibiotic use was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Days||Standard Deviation|Mean
1374272|NCT01519661|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1374273|NCT01519661|Secondary|Time to First Hospitalization Due to Serious Respiratory-related Adverse Events|The day of first hospitalization due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1374274|NCT01519661|Secondary|Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Days||Standard Deviation|Mean
1374275|NCT01519661|Secondary|Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1374276|NCT01519661|Secondary|Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa|Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had data at each time point/cycle were analyzed at each time point. The safety set included all participants who received at least one dose of study drug.|||ug/mL|||Number
1374277|NCT01519661|Secondary|Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum|Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.|Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had Pa sputum density values at both baseline and the given time point were included in the analysis. The safety set included all participants who received at least one dose of study drug.|||log10 Colony Forming Unit (CFU)||Standard Deviation|Mean
1374278|NCT01519661|Secondary|Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 – baseline FEF25-75) / baseline FEF25-75) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
1374279|NCT01519661|Secondary|Relative Change From Baseline in FVC Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted – baseline FVC % predicted) / baseline FVC % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
1374280|NCT01519661|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted – baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had FEV1 percent predicted values at both baseline and the post baseline time points were analyzed at each given time point. The safety set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
1374281|NCT01519661|Primary|Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths|Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.|337 days|Safety set: The safety set included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1374282|NCT01519648|Primary|The Rate of Invasive Fungal Infections|Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.|6 month||||participants|||Number
1374283|NCT01519518|Secondary|Door-to-first Device Time||28 days|||||||
1374284|NCT01519518|Secondary|Development of Thrombocytopenia||28 days|||||||
1374285|NCT01519518|Secondary|All Cause Mortality||1 year|||||||
1374286|NCT01519518|Secondary|For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes||28 days|||||||
1374287|NCT01519518|Secondary|Stent Thrombosis Rate (ARC Definite or Probable)||28 days||||percentage of total participants|||Number
1374288|NCT01519518|Secondary|Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition||28 days||||percentage of total participants|||Number
1374289|NCT01519518|Secondary|CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure||28 days|||||||
1374290|NCT01519518|Primary|Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition||28 days||||percentage of total participants|||Number
1374291|NCT01519518|Primary|Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization||28 days||||percentage of total participants|||Number
1374399|NCT01518153|Primary|Success Rate|Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).|100 days|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI. 9 participants did not meet the criteria to receive randomized planned DLI.|||participants|||Number
1374292|NCT01519466|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).~There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).~The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test."|Day 60 compared to day 1|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.|||Units on a scale||Standard Deviation|Mean
1374293|NCT01519466|Secondary|HbA1c|"HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).~The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol)."|Day 1 compared with Day 74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.|||Percentage of Glycosylated Haemoglobin||Standard Deviation|Mean
1374294|NCT01519466|Primary|Time in Target Blood Glucose Range|Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)|Day 1-15 compared with Day 60-74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.|||hours per day||Standard Deviation|Mean
1374295|NCT01519427|Secondary|Overall Survival|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.|||days||Full Range|Median
1374296|NCT01519427|Secondary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.|||days||Full Range|Median
1374297|NCT01519427|Secondary|Changes in Biomarker Expression|Pre-treatment tumor biopsy tissue and blood and day 7-14 tumor biopsy tissue and blood will be examined by immunohistochemistry for expression and phosphorylation of the proteins pERK, pMEK, pAKT, Ki67, pRpS6, CRAF, cyclin D, PDGFr, pPDGFr. IGFr1, and COT/Tp12 for changes from baseline|Before initiation of treatment and at 7-14 days, up to 2 years|This clinical trial was terminated early. The investigators did not perform any biomarker expression analyses.||||||
1374298|NCT01519427|Primary|Objective Response|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response.|||participants|||Number
1374299|NCT01519323|Secondary|Overall Survival (OS)|Overall survival was defined as the time between the date of first treatment to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of their last being known alive. Median overall survival was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until death (2 years)|Intent to treat population included all participants enrolled.|||days||95% Confidence Interval|Median
1374300|NCT01519323|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the day of first treatment and the first documentation of progressive disease or death. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Participants who were withdrawn from the study without documented progression were to be censored at the date of the last known tumor assessment when the participant was known to be progression free. Median PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until disease progression or death or which ever occur first (2 years)|Intent to treat population included all participants enrolled.|||days||95% Confidence Interval|Median
1374301|NCT01519323|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the number of participants that achieved a CR, PR or stable disease (SD) (SD for at least 6 weeks) as assessed by investigators according to the RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as at >=30% decrease under baseline of the sum of diameters of all target lesions. SD was defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Up to 2 years|Intent to treat population included all participants enrolled.|||percentage of participants|||Number
1374505|NCT01516736|Secondary|Depth of ANC Nadir in Cycle 1|The depth of ANC nadir was defined as the patient’s lowest ANC (10^9 cells/L) in Cycle 1.|Cycle 1 (3 weeks)|FAS set = full analysis set|||10^9 cells/L||Standard Deviation|Mean
1374302|NCT01519323|Secondary|Best Overall Response Rate (BORR)|BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants who achieved a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper–Pearson.|Up to 2 years|Intent to treat population included all participants enrolled.|||percentage of participants||95% Confidence Interval|Number
1374303|NCT01519323|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to approximately 2 years 11 months|Safety population included all participants who received at least one dose or a partial dose of study treatment.|||participants|||Number
1374304|NCT01519323|Secondary|Area Under the Concentration-Time Curve for Vemurafenib||Pre-dose, 2, 4, 8, 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 22 (each cycle is of 28 days)|Pharmacokinetic (PK) population included all enrolled participants who received at least one dose or a partial dose of study treatment and provided at least one post-dose blood sample for PK analysis.|||hour*nanogram per millitre (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1374305|NCT01519323|Primary|Maximum Tolerated Dose (MTD)/Recommended Dose|The MTD was defined as the dose level at which six evaluable participants had been treated and at most one participant experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 participant experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Up to 28 days of treatment|A MTD could not be determined in this study because of the low number of participants enrolled.||||||
1374306|NCT01519284|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity|AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.|8 days||||ng.h/mL||Standard Deviation|Mean
1374307|NCT01519284|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days||||ng.h/mL||Standard Deviation|Mean
1374308|NCT01519284|Secondary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.|8 days||||hours||Full Range|Median
1374309|NCT01519284|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days||||ng/mL||Standard Deviation|Mean
1374310|NCT01519271|Secondary|Montreal Cognitive Assessment (MoCA)|The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.|The MoCA was administered in the beginning and end of each study phase.|Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups.|||Score on MoCA||Standard Deviation|Mean
1374311|NCT01519271|Primary|Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)|"The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.~The scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale."|The ADCS-CGIC will be administered at the end of each study phase.|Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups. Over the course of this study 2 participants discontinued study participation.|||scores on the CGIC||Standard Deviation|Mean
1374312|NCT01519245|Secondary|Volume of Blood Loss After 12 Hours|Volume of chest tube loss at 12 hours (assuming the total volume of loss is blood).|12 hours following admission to the Intensive Care Unit||||mL||Standard Deviation|Mean
1374313|NCT01519245|Secondary|Volume of Blood Loss at 6 Hours|Volume of chest tube loss at 6 hours (assuming the total volume of loss is blood).|6 hours following admission to the Intensive Care Unit||||mL||Standard Deviation|Mean
1374314|NCT01519245|Primary|Number of Units of Packed Red Blood Cells (PRBC) Transfused Following Coronary Artery Bypass Graft Surgery|Research participants were to receive a blood transfusion in the Intensive Care Unit (ICU) post-operatively if hemoglobin reached a nadir of 80g/L, or at the discretion of the intensivist or cardiac surgeon according to patient clinical status. Transfusion was quantified based on the number of units of PRBC received. (1 unit = 1 bag of blood, as prepared by Canadian Blood Services). Clinical status of research participants was followed throughout their duration in the ICU only. Participation in this study ended upon transfer out of the ICU, to the Cardiology Ward.|From ICU admission to transfer to the Cardiology Ward (placebo group = 24.4 hours; trial group = 24.7 hours)|None of the research participants received PRBC transfusion postoperatively in the ICU.|||Unit(s) of PRBC|||Number
1374381|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
1374315|NCT01519245|Primary|Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood).|According to standard practice, research participants were be transferred to the intensive care unit (ICU) for post-operative monitoring. Measurement of chest tube output began immediately on arrival to the ICU. Hourly measurements were recorded. Data collection ended upon chest tube removal, or return to the operating room for exploratory surgery due to massive blood loss. As per ICU protocol, chest tubes were be removed when blood loss was recorded to be less than 200mL after six consecutive hours.|From ICU admission post-operatively to mediastinal chest tube removal (placebo group = 20.6 hours; trial group = 19.8 hours)|A total of 44 consented participants were randomized. Prior to unblinding, 3 of the randomized participants were withdrawn from the study due to discovery of ineligibility criteria (1 EF <50%, 1 weight <75kg, 1 CABG x 7). Therefore, a total 41 patients were included in final analysis.|||mL||Standard Deviation|Mean
1374316|NCT01519206|Secondary|Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment|Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.|Baseline to 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) subjects missed the 1 year visit.|||Percentage of Participants|||Number
1374317|NCT01519206|Secondary|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.|During Ulthera treatment||||Units on a scale||Full Range|Mean
1374318|NCT01519206|Secondary|Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.|"Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 60 days, 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) additional subjects missed the 1 year visit.|||Percentage of Participants|||Number
1374319|NCT01519206|Primary|Improvement in Overall Lifting and Tightening of Skin|Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.|Baseline to 90 days post treatment|Thirty-five (35) subjects were enrolled; 3 were screen failures. Thirty-two (32) subjects received study treatment. Three (3) subjects were lost-to-follow-up.|||percentage of participants improved|||Number
1374320|NCT01519167|Secondary|Number of Subjects Converted to Alternative Sedation or Anesthetic Therapy Due to Failure of Treatment of Study Drug and Rescue Medication||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||Participants|||Number
1374321|NCT01519167|Secondary|Total Amount of Rescue Analgesia (Fentanyl)|Total amount of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.|||microgram||Standard Deviation|Mean
1374322|NCT01519167|Secondary|Total Amount of Rescue Sedation (Midazolam)|Total amount of rescue sedation (midazolam) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.|||milligram||Standard Deviation|Mean
1374323|NCT01519167|Secondary|Frequency of Fentanyl Use for Analgesia|Frequency of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure.|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.|||Occurrence||Full Range|Median
1374324|NCT01519167|Secondary|Frequency of Midazolam Required for Sedation|Frequency of rescue sedation (midazolam) required to maintain a subject within the target sedation range (UMSS score greater than 1 or N-PASS score less than -2).|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.|||Occurrence||Full Range|Median
1374325|NCT01519167|Secondary|Time to First Dose of Rescue Midazolam From Start of Dexmedetomidine Infusion|Kaplan-Meier estimates of time in minutes to first dose of rescue midazolam from onset of study drug infusion|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||Hours||95% Confidence Interval|Median
1374326|NCT01519167|Secondary|Number of Subjects Who Were Adequately Sedated at Least 80% of Time|Subjects who are adequately sedated (UMSS score of 1 to 3 or NPASS score of -5 to -2) at least 80% of the time sedated with the study drug|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
1374327|NCT01519167|Secondary|Number of Subjects Who Have Undergone Procedures Without Artificial Ventilation or Intervention||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
1374329|NCT01519167|Primary|Number of Subjects Who Had Success in Sedation|"Success in sedation was defined by a combined endpoint which was the combination of the following:~Subject had adequate level of sedation (University of Michigan Sedation Scale [UMSS] score between 1 to 3 [minimally sedated to deeply sedated] or Neonatal Pain, Agitation and Sedation Scale [N-PASS] score between -5 to -2 [Light sedation]) at least 80% of the time the subject was given the study drug.~Subject had successfully completed the procedure without a need for rescue sedation (Midazolam).~Subject had undergone the procedure without artificial ventilation or intervention to restore baseline or normal hemodynamic status"|From baseline to end of post-treatment period (approximately 24 hours)|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
1374330|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374331|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)|The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||mg/dL||Standard Deviation|Mean
1374332|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis|The rheumatologist investigator assessed how the subject’s overall arthritis appeared at the time of the visit. This was an evaluation based on the subject’s disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator’s response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374333|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis|Subjects answered the following question, “Considering the possible effects of the arthritis, how are you feeling today?” The subject’s response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374334|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain|Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374335|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count|Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Swollen joints||Standard Deviation|Mean
1374336|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count|Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Tender/painful joints||Standard Deviation|Mean
1374337|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374382|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
1374338|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374339|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374340|NCT01519089|Secondary|Joint Pain Assessment (JPA)|The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to “select the number that best describes any joint pain that participant may have experienced over the past 24 hours” with response options ranging from “0-no joint pain” to “10-worst possible joint pain.”|Baseline, Week 4, 16, 28, 52|The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374341|NCT01519089|Secondary|Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Percentage of participants|||Number
1374342|NCT01519089|Secondary|Work Limitation Questionnaire (WLQ)|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline (BL), Week (W) 4, 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374343|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374344|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week (W) 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374345|NCT01519089|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374346|NCT01519089|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374347|NCT01519089|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||nails||Standard Deviation|Mean
1374348|NCT01519089|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374349|NCT01519089|Secondary|Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374350|NCT01519089|Secondary|Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported."|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374351|NCT01519089|Secondary|Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Percentage of participants|||Number
1374352|NCT01519089|Secondary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374353|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of body surface area (BSA)” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374354|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
1374355|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Percentage of participants|||Number
1374356|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
1374357|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
1374358|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
1374359|NCT01519089|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
1375417|NCT01505673|Secondary|Total Daily Insulin Dose|The 3 days average of the total daily dose of insulin used within 3 consecutive days prior office visit 6 month.|6-months||||IU||Inter-Quartile Range|Median
1374360|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374361|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374362|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374363|NCT01519089|Primary|Number of Participants With Malignancy Events _Week 0 Through Follow-up|For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist’s report to the central laboratory for a blinded review by a central pathologist.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.|||Participants|||Number
1374364|NCT01519089|Primary|Number of Participants With Adjudicated Cardiovacular Events|Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.|||Participants|||Number
1374365|NCT01519089|Primary|Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 16|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374366|NCT01519089|Primary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374380|NCT01518257|Post-Hoc|Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Weeks 4, 8 and 12|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.|||Score on a scale||Standard Deviation|Mean
1375418|NCT01505673|Secondary|Glucagon|Measured during mixed meal challenge test.|6-months||||pg/mL||Standard Deviation|Mean
1374367|NCT01519089|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
1374368|NCT01518946|Primary|Time to Onset of Syncope/Near Syncope While on Tilt Table|After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.|1 hour post-dose|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of randomized investigational product and who had at least 1 measurement of the time to onset of syncopal symptoms/near syncope during tilt-table testing.|||seconds||Standard Error|Least Squares Mean
1374369|NCT01518530|Secondary|Efficacy as Per the NDI-Neck Disability Index|The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented.|6 weeks|||||||
1374370|NCT01518530|Primary|Occiflex Device Safety|A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.|6 weeks||||Number of adverse effects|||Number
1374371|NCT01518374|Primary|Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration|"Frequency of treatment-emergent adverse events considered related to florbetapir administration by the study investigator. Related events with a frequency > 0.2% are reported.~(note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in Adverse Events section below)"|48 hours||||Participants|||Count of Participants
1374372|NCT01518322|Post-Hoc|Of the 22 Subjects With a High FeNO (>50ppb Age 12 Years and Above; >35ppb Age Less Than 12 Years)During the Original Study Visit, Number of Subjects Subsequently Treated With Asthma Medications or Diagnosed With Asthma.|A medical record review of the 22 subjects with a high FeNO Value (>50ppb age 12 years and above; >35ppb age less than 12 years)during the original study visit was conducted. The number of subjects who were either diagnosed with asthma or treated with asthma medications is presented.|4 to 6 months after the original study visit.|Of the 162 subjects in the per-protocol population, 22 had a high FeNO (>50ppb age 12 years and above; >35ppb age less than 12 years). A retrospective medical record review was conducted and the number of subjects either diagnosed with asthma or treated with asthma medications is presented.|||participants|||Number
1374373|NCT01518322|Secondary|Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study|The total number of subjects who reported prior episodes of cough, wheeze, and shortness of breath.|anytime prior to the single study visit|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.|||participants|||Number
1374374|NCT01518322|Primary|Relationship Between FeNO and the Prescription of ICS in Primary Care Practices|The total number of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.|||participants|||Number
1374375|NCT01518322|Primary|Relationship Between FeNO and the Diagnosis of Asthma|For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.|||participants|||Number
1374376|NCT01518270|Secondary|Eyelash Darkness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.|Baseline|All participants with values available.|||Units on a scale||Full Range|Mean
1375419|NCT01505673|Secondary|Beta-Cell Function|Fasting Glucose as a Measure of Beta-Cell Function|6-months||||mg/dL||Standard Deviation|Mean
1374383|NCT01518257|Secondary|Patient Global Impression of Change Score|The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.|Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1374384|NCT01518257|Secondary|Change From Baseline in WOMAC Physical Function Score|The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
1374385|NCT01518257|Secondary|Change From Baseline in WOMAC Pain Score|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
1374386|NCT01518257|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score|The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
1374387|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
1374388|NCT01518244|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).|||percentage of participants|||Number
1374389|NCT01518244|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).|||milllimeters mercury (mmHg)||Standard Deviation|Mean
1374390|NCT01518192|Secondary|Selected Subjective Symptoms in Patients and Control Subjects|Comparison of the number of patients and controls with selected 8 symptoms (fatigue, arthralgias, myalgias, headache, paresthesias, dizziness, irritability, or nausea) within the preceding week, irrespective of whether they were new or increased since erythema migrans.|Examination at 12 months|all participants who followed the protocol|||participants|||Number
1374391|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.|Comparison of the number of patients and controls with new or increased symptoms since erythema migrans at 12 months.|12 months|all participants who followed the protocol|||participants|||Number
1374392|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 12 months post inclusion|12 months|all participants who followed the protocol|||participants|||Number
1374393|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 6 months post inclusion|6 months|all participants who followed the protocol|||participants|||Number
1374394|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 2 months post inclusion|2 months|all participants who followed the protocol|||participants|||Number
1374395|NCT01518192|Primary|Adverse Events|Number of patients reporting adverse events|at 14 days|All participants who followed the protocol.|||participants|||Number
1374396|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.|Comparison of the number patients and controls with new or increased symptoms since erythema migrans at 6 months.|6 months|all participants who followed the protocol|||participants|||Number
1374397|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days|Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion|at 14 days post inclusion|All participants who followed the protocol were eligible for analysis|||participants|||Number
1374398|NCT01518153|Secondary|Overall Survival (OS)|Overall Survival is defined as the interval between day of transplant and day of death.|Every 3 months until day of death|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.|||days||Full Range|Median
1375420|NCT01505673|Secondary|Weight||6-months||||Kilograms||Standard Deviation|Mean
1374402|NCT01517984|Secondary|Percentage of Participants in the Experimental Arm Off Tacrolimus|Participants in the ‘Randomized to Tacrolimus Withdrawal’ group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies.|18 months post-randomization|Intent-to-treat|||percentage of participants|||Number
1374403|NCT01517984|Secondary|Percentage of Participants With Donor-Specific Memory Using Elispot|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-randomization|No analyses were performed due to early study closure.||||||
1374404|NCT01517984|Secondary|Percentage of Participants With New Donor Specific Antibodies (DSAs)|Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.|6 to 18 months post-randomization|Intent-to-treat|||percentage of participants|||Number
1374405|NCT01517984|Secondary|Participant Survival Rate|Number of participants who did not die within the course of this study.|6 to 18 months post-transplantation|Intent-to-treat|||participants|||Number
1374406|NCT01517984|Secondary|Allograft Survival Rate|Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study.|6 to 18 months post-randomization|Intent-to-treat|||participants|||Number
1374407|NCT01517984|Secondary|Incidence of Acute Rejection|Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the ‘Randomized to Tacrolimus Withdrawal’ group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events.|6 to 18 months post-randomization|Intent-to-treat|||participants|||Number
1374408|NCT01517984|Secondary|Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation|Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function|6 months post-transplantation, 24 months post-transplantation|Intent-to-treat|||mL/min||Standard Deviation|Mean
1374409|NCT01517984|Primary|Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization|The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.|IF/TA scores on protocol biopsies obtained at 24 months post-randomization will be compared to those obtained at the time of implantation for this measurement.|No analyses were performed due to early study closure.||||||
1374410|NCT01517893|Secondary|Decrease in Serum Chemokines|Determination of the effects of simvastatin treatment on multiple chemokines in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed prior to treatment and periodically while on treatment|||||||
1374411|NCT01517893|Secondary|Correlation Among Various Outcome Measures for Vitiligo|Comparison of all tested outcome measures to identify the level of correlation among them, including VASI, Sentinel Patch, Investigator's Global Assessment Score, and Patient's Global Assessment Score|Assessed at final study visit, 6 months after randomization|||||||
1374412|NCT01517893|Secondary|Increase in Patient's Global Assessment Score|Increase in Patient's Global Assessment Scores of 30% or more from baseline to last available visit|Assessed at final study visit, 6 months after randomization|||||||
1374413|NCT01517893|Secondary|Decrease in CXCR3 Expression on CD8+ T Cells|Determination of the effects of simvastatin treatment on CXCR3 expression in melanocyte-specific, autoreactive CD8+ T cells in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed prior to treatment and periodically while on treatment|||||||
1374414|NCT01517893|Secondary|Increase in Quality of Life (QoL) Score|Increased quality of life based on end of study questionnaire scores of subjects randomized to treatment with simvastatin versus placebo|Assessed at final study visit, 6 months after randomization|||||||
1374415|NCT01517893|Secondary|Decrease in Sentinel Patch Area|Decrease in percent depigmentation of sentinel patch lesion from baseline to last available study visit.|Assessed at final study visit, 6 months after randomization|||||||
1374416|NCT01517893|Secondary|Safety and Tolerability of High-dose Simvastatin Use in Vitiligo Patients.|Monitoring lab values and patient symptoms for evidence of simvastatin toxicity|Assessed at every visit following randomization (monthly for 6 months)|||||||
1374417|NCT01517893|Secondary|Increase in Investigator's Global Assessment Score|Increase in Investigator Global Assessment Scores of 30% or more from baseline to last available visit|Assessed at final study visit, 6 months after randomization|||||||
1374418|NCT01517893|Primary|Decrease in VASI Score|Number of participants with 33% decrease in the Vitiligo Area Scoring Index (VASI) from baseline to the last available study visit|Assessed at final study visit, 6 months after randomization||||participants|||Number
1374419|NCT01517867|Secondary|Aggregate Cost|Combined provider (based on billing records) and parent cost (based on self-report).|through end of study (up to 2 years)|Cost collected for 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect cost data from the remaining participants who enrolled in study but never attended any treatment.|||dollars||Standard Deviation|Mean
1374420|NCT01517867|Primary|Change in Child Behavior Problems|parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.|baseline, first follow-up (up to 2 years)|First follow-up data collected from 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect follow-up data from remaining participants who enrolled in study but never attended any treatment.|||units on a scale||Standard Deviation|Mean
1374423|NCT01517750|Secondary|Nasopharyngeal Complaints|"Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 (“no complaints”) to 5 (“very strong). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25."|6 weeks after patient randomization||||units on a scale||Standard Deviation|Mean
1374424|NCT01517750|Secondary|Functional Outcome of Sleep Questionnaire (FOSQ)|"FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = I don't do this activity for other reasons, 1=Yes extremely, 2=Yes moderately, 3= Yes a little, 4 = No. Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities."|6 weeks after patient randomization||||units on a scale||Standard Deviation|Mean
1374425|NCT01517750|Secondary|Epworth Sleepiness Score (ESS)|The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness|6 weeks after patient randomization||||units on a scale||Standard Deviation|Mean
1374426|NCT01517750|Primary|Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.||6 weeks after patient randomization||||minutes||Standard Deviation|Mean
1374427|NCT01517529|Secondary|Number of Participants Who Cleared the Virus|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses|9 months||||participants|||Number
1374428|NCT01517529|Primary|Number of Participants Who Completed Standard Treatment|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.|9 months|Measure HCV viral load and HCV-specific immune responses at baseline|||participants|||Number
1374429|NCT01517412|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.|Baseline, Week 24|mITT population.|||Units on a scale||Standard Error|Least Squares Mean
1374430|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24|On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
1374431|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period|Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
1374432|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24|Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
1374433|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
1374434|NCT01517412|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|Baseline, Week 24|mITT population.|||kg||Standard Error|Least Squares Mean
1374435|NCT01517412|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|Baseline, Week 24|mITT population.|||mmol/L||Standard Error|Least Squares Mean
1374885|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)||Pre abiraterone dose on Day 1 of Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||ng/mL||Standard Deviation|Mean
1374436|NCT01517412|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|Baseline, Week 24|mITT population.|||mmol/L||Standard Error|Least Squares Mean
1374437|NCT01517412|Secondary|Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24|Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Week 24|mITT population.|||Percentage of participants|||Number
1374438|NCT01517412|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug and had both baseline and at least one post-baseline assessment of any primary or secondary efficacy endpoints, irrespective of compliance with study protocol and procedures.|||Percentage of hemoglobin||Standard Error|Least Squares Mean
1374439|NCT01517373|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure|||participants|||Number
1374440|NCT01517373|Secondary|Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||kilogram (kg)||Standard Deviation|Mean
1374441|NCT01517373|Secondary|Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant|Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.|Baseline (Day 1) up to Week 14|Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.||||||
1374442|NCT01517373|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||events per participant||Full Range|Median
1374443|NCT01517373|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1374444|NCT01517373|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1374445|NCT01517373|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator’s discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure|||participants|||Number
1374446|NCT01517373|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data|Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia’s correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure.|||participants|||Number
1374447|NCT01517373|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.|Week 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure.|||percentage of participants|||Number
1374448|NCT01517373|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12||Baseline (Day 1), Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1374449|NCT01517373|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 2, 4, 6, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.|||percentage of hemoglobin||Standard Deviation|Mean
1374450|NCT01517373|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||percentage of hemoglobin||Standard Deviation|Mean
1374451|NCT01517295|Secondary|Peak Urine Concentration of Hydromorphone|Analyze the urine concentration of hydromorphone|Up to 4 hours||||ng/mL||Standard Deviation|Mean
1374452|NCT01517295|Secondary|Correlation of Plasma PK of Hydrocodone|Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.|1 Month|Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.||||||
1374453|NCT01517295|Primary|Peak Plasma Concentration of Hydromorphone|Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.|Up to 6 hours||||ng/mL||Standard Deviation|Mean
1374454|NCT01517282|Secondary|Number of New or Enlarging T2 Lesions|T2-weighted magnetic resonance imaging (MRI) tests were performed at Weeks 8, 12, and 16 to assess the number of new or enlarging T2 brain lesions, a sign of MS activity. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 8, 12, and 16 were:~MOR103 0.5 mg/kg: 8,8,8 MOR103 1.0 m/kg: 6,6,6 MOR103 2.0 mg/kg: 7,7,7 Placebo: 6, 4, 5"|||Number of new or enlarging T2 lesions|||Number
1374455|NCT01517282|Secondary|Number of New T1 Gadolinium-enhancing Lesions|Magnetic resonance imaging (MRI) tests were performed at screening (to confirm subject eligibility) and at Weeks 4, 8, 2, and 16. MRIs at post-screening time points were used to assess the number of new lesions as revealed by gadolinium (Gd) enhancement. Gd-enhanced MRIs reveal new brain lesions reflecting areas of active inflammation. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 4, week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 4, 8, 12, and 16 were:~MOR103 0.5 mg/kg: 8,8,8,8 MOR103 1.0 m/kg: 6,6,6,6 MOR103 2.0 mg/kg: 8,7,7,7 Placebo: 6, 6, 4, 5"|||Number of new T1 Gd-enhancing lesions|||Number
1374456|NCT01517282|Secondary|Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC|At week 0 (first dose) and week 10 (last dose), serum samples were obtained at pre-dose and at 1, 2, 4, and 336 hours after start of dosing. To calculate the accumulation ratio, the apparent AUC calculated for the last dose was divided by the apparent AUC following the first dose using the described time points for each dosing. Because AUC is a summary outcome, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). Data were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).|||ratio of AUC values||Standard Deviation|Mean
1375421|NCT01505673|Secondary|Pancreatic and Hepatic Triglyceride Content|Liver Triglyceride and Pancreatic Triglyceride|6-months||||Percent Triglyceride||Standard Deviation|Mean
1374457|NCT01517282|Secondary|Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Tmax values for each patient were calculated based on these data, and the mean Tmax values for the dose cohort are presented here. Because Tmax refers to the time to maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).|||hour||Standard Deviation|Mean
1374458|NCT01517282|Secondary|Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Cmax values for each patient were calculated based on these data, and the mean Cmax values for the dose cohort are presented here. Because Cmax refers to the maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable, as they represent the concentration of MOR103, but not the Cmax.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).|||mg/L||Standard Deviation|Mean
1374459|NCT01517282|Secondary|Mean Serum Concentration of MOR103 Over Time|MOR103 serum levels were measured at each visit. At all visits during the dosing period (weeks 0, 2, 6, 8, and 10), serum samples were taken before MOR103 administration (pre-dose) and 1 hour after the dose. In addition, at week 0 (first dose) and week 10 (last dose), additional samples were obtained at 2 hours and 4 hours after MOR103 administration. At visits that followed the dosing period (weeks 12, 14, 16, and 20), a single serum sample was obtained at any time during the visit.|Week 0 (dose 1) to week 20 (end of study)|Pharmacokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data were not available for all patients at each time point.|||mg/L||Standard Deviation|Mean
1374460|NCT01517282|Secondary|Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples|To assess the potential immunogenicity of MOR103, a central bioanalytical laboratory (Eurofins Medinet BV, Breda, The Netherlands) tested serum samples obtained at baseline and at 3 post-treatment time points (week 14, week 16, and week 20/end of study) for anti-MOR103 antibodies.|Baseline, week 14, week 16, and week 20/end of study|All subjects who received 1 or more dose of placebo or MOR103 (safety population). Data were missing for 1 patient each in the MOR103 1.0 mg/kg and 2.0 mg/kg groups at week 14 and week 16. Data were also missing for 1 patient in the placebo group at all post-baseline timepoints (week 14, 16, and 20).|||percentage of participants|||Number
1374461|NCT01517282|Primary|Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)|The safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) was assessed by evaluation of the incidence of TEAEs and TESAEs. A full listing of adverse events recorded during this trial can be found in the Adverse Events section. AEs were regarded as treatment emergent if they started on or after the first date of study drug administration or if they were present prior to the first date of study drug administration and increased in severity or relationship to study drug during the study. AEs were coded using MedDRA version 16.1|From the first dose (week 0) to study endpoint (week 20)|All subjects who received 1 or more dose of placebo or MOR103 (safety population).|||percentage of participants|||Number
1374462|NCT01517178|Primary|Degree of Output Under the Base Plate (Leakage).|Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).|Each test product was assessed for 2 weeks.||||units on a scale|Participants|Standard Deviation|Mean
1374463|NCT01517074|Secondary|Step Changes in Scleral Inflammation According to the Standardized Photographic Grading System Developed at National Eye Institute (NEI)||Baseline and Week 52|||||||
1374464|NCT01517074|Secondary|Number of Participants Who Experience a Substantial Rise in Elevated Intraocular Pressure (IOP)|A substantial rise in intraocular pressure can be defined as ≥10 mmHg change in pressure.|Baseline and Week 52||||participants|||Number
1374465|NCT01517074|Secondary|Proportion of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|||||||
1374466|NCT01517074|Secondary|Number of Participants Who Tapered Off One or More Systemic Immunosuppressive Medications or Tapered Off Prednisone (≤10 mg) After Week 16|Four (4) out of 5 participants were on immunosuppressive medications at enrollment.|Week 16 and Week 52||||participants|||Number
1374467|NCT01517074|Secondary|Number of Participants Who Experienced Systemic Toxicities||Baseline and Week 52||||participants|||Number
1374468|NCT01517074|Secondary|Number of Participants Who Experienced Ocular Toxicities||Baseline and Week 52||||participants|||Number
1374469|NCT01517074|Secondary|Mean Number of Days Between the First Injection to the Second Injection|For participants who demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection|Baseline and Week 52||||Days||Full Range|Mean
1374470|NCT01517074|Secondary|Number of Participants Needing a Second Injection|Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).|Baseline and Week 52||||participants|||Number
1375422|NCT01505673|Primary|Glycemic Control Measured by HbA1c|HbA1c (%)|6-months||||Percent HbA1c||Standard Deviation|Mean
1374471|NCT01517074|Secondary|Median Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|||||||
1374472|NCT01517074|Secondary|Mean Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|||||||
1374473|NCT01517074|Secondary|Number of Participants Who Experience a Disease Flare as Defined by a ≥ 1-step Increase in Scleral Inflammation|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)|Baseline and Week 52||||participants|||Number
1374474|NCT01517074|Primary|Number of Participants Who Experience at Least 2-step Reduction or Reduction to Grade 0 of Scleral Inflammation in the Study Eye According to the National Eye Institute (NEI) Photographic Scleritis Grading System Within 8 Weeks Post-injection.|"The primary efficacy outcome was a 2-step reduction in scleritis grading out of a scale of 0 to 4+ (where 0.5+ is recognized as an ordinal step between 1+ and 0+).~Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can’t be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)."|Baseline and Week 8||||participants|||Number
1374475|NCT01516970|Secondary|Percentage of Participants Who Developed Detectable HIV Antibodies|Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies (defined as positive) and percentage of participants who had not developed detectable HIV antibodies (defined as negative). Per protocol (PP) population included all participants in mITT (defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|At Month 3|Analysis was performed on PP population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1374476|NCT01516970|Secondary|Worst Sheehan Disability Scale (SDS) Score for the Safety Population|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 inter-related domains: work/school, social and family life, using a rating scale for each item ranging from 0 (not at all) to 10 (extremely).|Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.|||units on a scale||Standard Deviation|Mean
1374477|NCT01516970|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined to be non-treatment-emergent if the onset date of the AE was clearly before the date of first HIV PEP administration, otherwise it is considered treatment-emergent.|Up to Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.|||participants|||Number
1374478|NCT01516970|Primary|Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)|Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT [defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person]) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|Up to 30 days|Analysis was performed on PP population.|||participants||95% Confidence Interval|Number
1374479|NCT01516892|Secondary|Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score|The HIT-6 measures the impact of headache and treatment on the participant’s functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.|Baseline, Week 60, Week 108|Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1374480|NCT01516892|Secondary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 60|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.|||headache days||Standard Deviation|Mean
1374481|NCT01516892|Primary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 108|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.|||headache days||Standard Deviation|Mean
1374482|NCT01516879|Secondary|Percent Change From Week 12 to Week 52 in LDL-C|Cholesterol was measured by means of ultracentrifugation.|Week 12 and Week 52|The Effect Durability Analysis Set included participants in the FAS who adhered to the scheduled study drug and had nonmissing LDL-C values at Baseline, Week 12 and Week 52.|||percent change||Standard Error|Least Squares Mean
1374483|NCT01516879|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374484|NCT01516879|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374485|NCT01516879|Secondary|Percent Change From Baseline in Triglycerides at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374486|NCT01516879|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374487|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374488|NCT01516879|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374489|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 52||Baseline and Week 52|Full analysis set|||percent change||Standard Error|Least Squares Mean
1374490|NCT01516879|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374491|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374492|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
1374493|NCT01516879|Secondary|Percent Change From Baseline in LDL-C at Week 12|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 12|Full Analysis set|||percent change||Standard Error|Least Squares Mean
1374494|NCT01516879|Secondary|Percentage of Participants With an LDL-C Response at Week 52|An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.|Week 52|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1374495|NCT01516879|Secondary|Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set|||mg/dL||Standard Error|Least Squares Mean
1374496|NCT01516879|Primary|Percent Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set (all randomized subjects who received at least 1 dose of study drug).|||percent change||Standard Error|Least Squares Mean
1374497|NCT01516749|Secondary|Change in C-reactive Protein|Change assessed from baseline to end of treatment phase.|Baseline, 8 weeks|Patients who completed 8 weeks of therapy|||mg/L||95% Confidence Interval|Mean
1374498|NCT01516749|Secondary|Change in Dermatology Quality of Life Index (DLQI)|Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life|Baseline, 8 weeks|Patients who completed 8 weeks of therapy|||units on a scale||95% Confidence Interval|Mean
1374499|NCT01516749|Secondary|Change in Quality of Life Assessments|"The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).~The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit? with a scale of 0=no acitivity to 100=maximal activity."|Baseline, 8 weeks|Patients who completed 8 weeks of therapy|||units on a scale||95% Confidence Interval|Mean
1374500|NCT01516749|Primary|Change in Modified Sartorius Score|"At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5–10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.~Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity."|Baseline, 8 weeks|The 5 patients who completed 8 weeks of therapy|||units on a scale||95% Confidence Interval|Mean
1374501|NCT01516736|Secondary|Mortality Due to Infection|Number of patients with death due to infections|Study course (19 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
1374502|NCT01516736|Secondary|Frequency of Infections by Cycle and Across All Cycles|The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class “Infections and Infestations”.|across all cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
1374503|NCT01516736|Secondary|Time to ANC Recovery in Days in Cycle 1|Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient’s ANC had increased to ≥ 2 × 10^9 cells/L after the nadir in Cycle 1.|across Cycle 1 (3 weeks)|FAS set = full analysis set|||days||Standard Deviation|Mean
1374506|NCT01516736|Secondary|Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles|Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.|across al cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
1374507|NCT01516736|Secondary|Incidence of Febrile Neutropenia (FN)|FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (“febrile neutropenia”, “neutropenic sepsis”) were taken into account.|across all cycles (18 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
1374508|NCT01516736|Primary|Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).|21 days (Cycle 1 of chemotherapy treatment)|Missing patients in FAS set due to blind data review meeting decision (no ANC profiles available). FAS set = full analysis set; PP set = per protocol set|||days||Standard Deviation|Mean
1374509|NCT01516632|Secondary|Continuous Abstinence at 4-weeks Post-quit|Smoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other|4 weeks post-quit||||participants|||Number
1374510|NCT01516632|Secondary|Point Prevalence|A cigarette, even just a puff, within the last 7 days (yes/no).|4-weeks post-quit||||participants|||Number
1374511|NCT01516632|Primary|Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations|"Continuous abstinence is defined as 5 or fewer cigarettes smoked since one's quit date. The question was asked based upon West et al., 2005: Have you smoked at all, even just a puff, since [insert quit date]? If yes, the respondent will be probed for how many cigarettes were smoked. Responses will be categorized into one of three options: A) No, not a puff; B) 1-5 cigarettes; C) More than 5 cigarettes.~Self-reported cessation is confirmed by a significant other."|3-months post-quit||||participants|||Number
1374512|NCT01516437|Secondary|Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
1374513|NCT01516437|Secondary|Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
1374514|NCT01516437|Secondary|Number of Subjects With Positive Sputum - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
1374515|NCT01516437|Secondary|Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||T cells/million cells||Standard Deviation|Mean
1374516|NCT01516437|Secondary|Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||T cells/million cells||Standard Deviation|Mean
1374517|NCT01516437|Primary|Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%|Concentrations were expressed as geometric mean concentrations (GMCs)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||Subjects|||Number
1374518|NCT01516437|Primary|Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%|Concentrations were expressed as geometric mean concentrations (GMCs)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
1374519|NCT01516437|Primary|Concentrations for Serum Protein-D Enzymatic Inhibition|Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
1374520|NCT01516437|Primary|Concentrations for Serum Protein-D Enzymatic Inhibition|Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
1374521|NCT01516437|Primary|Anti-pneumolysin Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
1374522|NCT01516437|Primary|Anti-pneumolysin Antibody Concentrations|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
1374523|NCT01516437|Primary|Anti-Pneumococcal Histidine Triad D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
1374524|NCT01516437|Primary|Anti-Pneumococcal Histidine Triad D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
1374525|NCT01516437|Primary|Anti-protein D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
1374526|NCT01516437|Primary|Anti-protein D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
1374527|NCT01516268|Primary|Narcotic Dosage|The total dosage of morphin consumed by the patients in sufentanil or control group.|over 24 hours after surgery||||mgm,.||Standard Deviation|Mean
1374528|NCT01516268|Secondary|Pain||24h|||||||
1374529|NCT01516268|Primary|Narcotic Dosage||24 h|||||||
1374530|NCT01516034|Secondary|Tolerability Score|The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.|0, 2, 4, 6, 8, 10 weeks (after every treatment)|||||||
1374531|NCT01516034|Primary|Tattoo Removal Efficiency|"Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:~Scoring by independent dermatologist~Measuring pigment clearance using image analysis"|6 months (termination)|The number of participants that completed follow up.||||||
1374532|NCT01516008|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage of participants|||Number
1374533|NCT01516008|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.|||Scores on a scale||Standard Deviation|Mean
1374534|NCT01516008|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values|||Scores on a scale||Standard Deviation|Mean
1374535|NCT01516008|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.|||Scores on a scale||Standard Deviation|Mean
1374536|NCT01516008|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage of participants|||Number
1374736|NCT01513538|Primary|Acceptance of TherapyGuide Proposals and Typology of Programming Changes|"The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians.~Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications."|30 months||||percentage of patients|||Number
1374537|NCT01516008|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage of participants|||Number
1374538|NCT01516008|Secondary|Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours|Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|Baseline (Day 1) and 12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage Reduction||Inter-Quartile Range|Median
1374539|NCT01516008|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|Up to 48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Hours||Inter-Quartile Range|Median
1374540|NCT01516008|Primary|Sum of Pain Intensity Differences (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.|||Scores on a scale||Standard Deviation|Mean
1374541|NCT01515956|Secondary|Change From Baseline in Normalized Growth Rate Z-Scores|Changes in growth over time will be assessed using anthropometric measurements and radiographs of lower extremities. Z-scores are the normalized scores derived from the reference population mean and standard deviation (A positive change from baseline indicates that the population has moved closer to the reference population and represents a positive outcome).|Baseline to Week 52|Efficacy analysis set - All enrolled patients with at least 1 post treatment efficacy measurement will be included in efficacy analyses.|||z-score||Standard Deviation|Mean
1374542|NCT01515956|Secondary|Percent Change From Baseline to Week 52 in Urinary Keratan Sulfate Measures|Percent Change from Baseline to Week 52 for Urinary Keratan Sulfate measures.|Baseline to Week 52|Efficacy Analysis Set - All enrolled patients with at least 1 post treatment efficacy measurement will be included in efficacy analyses.|||percentage change||Standard Deviation|Mean
1374543|NCT01515956|Primary|To Evaluate Safety and Tolerability of Infusions of BMN 110 at a Dose of 2.0 mg/kg/Week Over a 52-week Period in MPS IVA Subjects Less Than 5 Years of Age at Time of First Study Drug Infusion|Number of Participants Experiencing Adverse Events|52 weeks|Safety Population|||Participants|||Count of Participants
1374544|NCT01515943|Secondary|Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group|"Improvement in all 3 outcome measures at 6 weeks will be defined as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline~Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763~Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419~(Note: All 3 criteria must be met in order to be classified as an improver at the 6-week visit)."|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374545|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group|"The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 6-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:~Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a 6-week mean NPC break <6 cm~Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a 6-week mean PFV blur >15 pd"|6-weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374546|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean PFV blur at the 6-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 6 weeks and a 6-week to baseline ratio of >1.419 for mean PFV blur.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374547|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean NPC break at the 6-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 6 weeks and a 6-week to baseline ratio of <0.763 for mean NPC break.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1375455|NCT01505387|Primary|Mean Change in Body Weight From Baseline to End of 24 Weeks|Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction|24 weeks||||kg||Standard Deviation|Mean
1374548|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group|The number of subjects classified as a success based on signs/symptoms at the 6-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 6-week score of <16 points.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374549|NCT01515943|Secondary|Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group|"To be considered an overall success, each of the following criteria must be met for the 3 outcome measures at 6 weeks:~Convergence Insufficiency Symptom Survey (CISS): 6-week score <16 points and at least 9-point improvement from baseline at 6 weeks~Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a mean 6-week NPC break <6 cm~Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a mean 6-week PFV break >15 pd~(Note: All 3 criteria must be met in order to be classified as an overall success at the 6-week visit)."|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374550|NCT01515943|Post-Hoc|Number of Participants Classified as an Overall Success at 12 Weeks in the HB-C Group According to Whether or Not the Computer-based Therapy Program Was Completed at 12 Weeks|"This outcome was limited to participants randomly assigned to the HB-C group.~Completion of the home-based computer therapy program was defined as achieving at least 15 stars on the jump vergence therapy).~Overall success was defined as meeting the following criteria for all 3 outcome measures at 12 weeks:~Convergence Insufficiency Symptom Survey (CISS): 12-week score of <16 points and at least a 9-point improvement from baseline at 12 weeks~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur > 1.419 and a 12-week mean PFV blur >15 pd"|12 weeks after randomization (baseline)|The analysis was limited to participants who were randomly assigned to the HB-C group who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).|||participants|||Number
1374551|NCT01515943|Secondary|Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group|"Improvement in all 3 outcome measures at 12 weeks will be defined as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763~Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur >1.419~(Note: All 3 criteria must be met in order to be classified as an improver at the 12-week primary outcome visit)."|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374552|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group|"The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 12-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a 12-week mean PFV blur >15 pd"|12-weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374553|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean PFV blur at the 12-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 12 weeks and a 12-week to baseline ratio of >1.419 for mean PFV blur.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374554|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean NPC break at the 12-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 12 weeks and a 12-week to baseline ratio of <0.763 for mean NPC break.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374555|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group|The number of subjects classified as a success based on signs/symptoms at the 12-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 12-week score of <16 points.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
1374589|NCT01515306|Primary|Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion|All participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 1 of Part B.|||micrograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1374556|NCT01515943|Primary|Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P|"Pairwise treatment group comparison (HB-C versus Placebo) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons.~Overall success was defined as meeting all of the following criteria at 12 weeks:~Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd"|12-weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).|||Participants|||Count of Participants
1374557|NCT01515943|Primary|Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU|"Pairwise treatment group comparison (HB-C versus HB-PU) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons (Type I error rate = 2.5%).~Overall success was defined as meeting all of the following criteria at 12 weeks:~Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd"|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).|||Participants|||Count of Participants
1374558|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||h⋅ng-eq/mL||Standard Deviation|Mean
1374559|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||h⋅ng-eq/mL||Standard Deviation|Mean
1374560|NCT01515891|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||hours||Standard Deviation|Mean
1374561|NCT01515891|Primary|Maximum Plasma Concentration (Cmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||ng-eq/mL||Standard Deviation|Mean
1374562|NCT01515865|Primary|Percent of Subjects Who Failed to Maintain a Response|"Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:~The Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by >=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms.~There was an increase in the number of syncopal/near syncopal events or severity of events within 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness."|30 minutes post-dose on Day 16|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of double-blind investigational product.|||percentage of participants|||Number
1374563|NCT01515696|Post-Hoc|Necrotizing Enterocolitis|necrotizing enterocolitis stage 2a after Bell|End of study||||participants|||Number
1374564|NCT01515696|Secondary|Feeding Tolerance- Full Enteral Feedings|full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg|days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg|per protocol|||days||Full Range|Median
1374565|NCT01515696|Primary|Time to Complete Meconium Evacuation in Days|Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life|days of life until until the complete meconium evacuation from birth up to 40 days of life|per protocol|||days of life||Full Range|Median
1374566|NCT01515657|Primary|Time to 99% Inhibition of Serum Thromboxane (TxB2)|Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|4 days|Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition|||Hours||Standard Deviation|Mean
1374567|NCT01515566|Secondary|Effect of Fentanyl on Walk Distance|Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.|Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.||||feet||Standard Deviation|Mean
1374568|NCT01515566|Primary|Retention Rate|Retention rate is defined as the percentage of subjects able to complete the study.|Baseline to study completion, up to 100 minutes.||||percentage of participants|||Number
1374614|NCT01515072|Secondary|Delayed Graft Function (DGF) of Kidney Recipients.|DGF is defined as the need for dialysis within the first week post transplantation.|7 days post-transplant|Kidney recipients of donors in each arm.|||participants|Kidney Recipients||Number
1374569|NCT01515566|Secondary|Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea|Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 (“no shortness of breath”) to 10 (“worst possible shortness of breath”) and every 5 minutes during the rest period.|Baseline to 100 minutes for study participation.||||units on a scale||Standard Deviation|Mean
1374570|NCT01515540|Primary|"Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents no Pain and 100 Was the Worst Pain Imaginable."|"the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch.~A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful."|2 weeks|based on a literature search.|||peak pain intensity||Standard Deviation|Mean
1374571|NCT01515488|Secondary|Patient Satisfaction|Custom survey with 4 items capturing satisfaction with Understanding, Ease of Answering Questions, Respect for Privacy, and Overall Feelings. For each item, the lowest possible score was 1 and the highest possible score was 6. For Understanding, the lowest actual score was 2 and the highest actual score was 6. For Ease of Answering Questions, the lowest actual score was 2 and the highest actual score was 6. For Respect for Privacy the lowest actual score was 3 and the highest actual score was 6. For Overall Feelings, the lowest actual score was 3 and the highest actual score was 6. For the (unweighted) average of all 4 items, the lowest possible score was 1 and the highest possible score was 6. The lowest actual score was 3.5 and the highest actual score was 6.0.|Upon completion of triage.||||units on a scale||Standard Deviation|Mean
1374572|NCT01515488|Secondary|Accuracy of Medical History|To check for accuracy of medical history information, two RAs approached enrolled parents during the course of their ED visit in the individual patient examination rooms. The RAs conducted a brief face-to-face interview with parents and verified information from the nursing triage summary sheet (for non-kiosk users) and the printout of history sheet from the kiosk users, noting any discrepancies on a Discrepancy Rating Scale. All historical discrepancies were categorized into three groups: major discrepancy, minor discrepancy and no discrepancy.|Upon completion of triage.||||Inaccuracies||Standard Deviation|Mean
1374573|NCT01515488|Primary|Triage Time|The time it takes for the patient to be triaged, compared across the kiosk and nurse-initiated triage conditions.|From beginning of triage to completion of triage.||||Seconds||Standard Deviation|Mean
1374574|NCT01515423|Secondary|Change From Baseline in Marder Factor Subscale Score at Week 48|5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1374575|NCT01515423|Secondary|Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1374576|NCT01515423|Secondary|Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria|Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.|Weeks 41 to 65|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1374577|NCT01515423|Secondary|Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48|The Personal and Social Performance (PSP) scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1374615|NCT01515072|Secondary|Six Month Hospital Free Survival of All Organ Recipients|Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant.|6 months post-transplant|Recipients of all organs from donors enrolled in the two arms|||days||Inter-Quartile Range|Median
1374578|NCT01515423|Secondary|Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1374579|NCT01515423|Secondary|Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1374580|NCT01515423|Primary|Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase|Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.|Up to 48 weeks|Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1374581|NCT01515410|Primary|"The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent OFF Time."|"OFF indicates wearing off motor fluctuations before the next levodopa dose. Percent OFF time is calculated as the total OFF time divided by the total awake time for each day and multiplied by 100.~Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.~Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.~End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.~Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits."|Baseline and 10 days for each of the 2 study periods|Modified Intent-to-treat (ITT) Population|||percentage of time||95% Confidence Interval|Least Squares Mean
1374582|NCT01515345|Secondary|Probable Stent Thrombosis|"Probable stent thrombosis is considered to have occurred in case of~any unexplained death within the first 30 days.~any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure"|30days||||participants|||Number
1374583|NCT01515345|Primary|Any Bleeding Event|"Bleeding classified by the TIMI hemorrhage classification scheme:~Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL~Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL"|30days||||participants|||Number
1374584|NCT01515345|Primary|Definite Stent Thrombosis|"The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis"|30 days||||participants|||Number
1374585|NCT01515306|Secondary|Part B: Immunogenicity of Ramucirumab as Monotherapy - Incidence of Anti-Ramucirumab Antibodies||0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug||2019-12-31|12/2019||||
1374586|NCT01515306|Secondary|Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Incidence of Anti-Ramucirumab Antibodies||-1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug||2019-12-31|12/2019||||
1374587|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel|Dose-normalized Cmax was calculated from Cmax divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2 of Part A.|||micrograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
1374588|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2 of Part A.|||micrograms*hour/milliliters/milligram||Geometric Coefficient of Variation|Geometric Mean
1374616|NCT01515072|Secondary|Pulsatile Perfusion Flow|Perfusate flow (mL/min) in machine perfused kidneys.|Up to 24 hours of machine perfusion||||mL/min||Standard Deviation|Mean
1374590|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 2.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1374591|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 1.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1374592|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 2.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1374593|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 1.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
1374594|NCT01515189|Secondary|Overall Survival of Participants With Brain Metastases at Baseline|OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants with brain metastases at baseline|||months||95% Confidence Interval|Median
1374595|NCT01515189|Secondary|Rate of Overall Survival|OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.|From date of randomization until 5 years (ongoing)|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1374596|NCT01515189|Secondary|Duration of Stable Disease by mWHO Criteria|Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||months||95% Confidence Interval|Median
1374597|NCT01515189|Secondary|Duration of Response by mWHO Criteria|Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||months||95% Confidence Interval|Median
1374598|NCT01515189|Secondary|Disease Control Rate (DCR) by mWHO Criteria|DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or “not evaluable” assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||percentage of participants with DC||95% Confidence Interval|Number
1374617|NCT01515072|Secondary|Change in Troponins|Change in serum troponin I (ng/mL) from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days|Only donors in whom two troponin I values (one before intervention and another after the initial intervention) were available were included in this analysis|||ng/mL||Inter-Quartile Range|Median
1374599|NCT01515189|Secondary|Best Overall Response Rate (BORR) by mWHO Criteria|BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or “not evaluable” assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||percentage of participants with BORR||95% Confidence Interval|Number
1374600|NCT01515189|Secondary|Progression Free Survival (PFS) by mWHO Criteria|PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants.|||months||95% Confidence Interval|Median
1374601|NCT01515189|Primary|Overall Survival (OS)|OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||months||95% Confidence Interval|Median
1374602|NCT01515176|Secondary|Time to Treatment Failure|Distributions will be explored and assessed using the methods of Kaplan and Meier.|Time from study entry to the date patients end treatment, up to 28 weeks||||days||95% Confidence Interval|Median
1374603|NCT01515176|Secondary|Progression Free Survival|95% confidence intervals will be constructed using the methods of Duffy and Santner with the assumption that these rates are binomially distributed. Distributions will be explored and assessed using the methods of Kaplan and Meier.|Time from study entry to documentation of disease progression and/or death, assessed up to 5 years||||days||95% Confidence Interval|Median
1374604|NCT01515176|Secondary|Overall Survival|Distributions will be explored and assessed using the methods of Kaplan and Meier.|Time from study entry to death due to any cause, assessed up to 5 years||||days||95% Confidence Interval|Median
1374605|NCT01515176|Secondary|Complete Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions|Up to 28 weeks||||patients with complete response||95% Confidence Interval|Number
1374606|NCT01515176|Primary|Percentage of Patients Who Achieve an Overall Response, Defined as Achieving a Complete Response, an Unconfirmed Complete Response (SLL Only), or a Partial Response (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 28 weeks||||percentage of patients||95% Confidence Interval|Number
1374607|NCT01515176|Primary|Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I)|Hematologic dose-limiting toxicity measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via CTCAE version 4 standard toxicity grading. Non-hematologic dose-limiting toxicities such as dyspnea and renal will be evaluated via the ordinal CTCAE standard toxicity grading only.|Up to day 56||||Participants|||Count of Participants
1374608|NCT01515176|Primary|Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia)|Graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0. Assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization.|Day 56||||mg/m2|||Number
1374609|NCT01515072|Post-Hoc|Recipient Survival|Kaplan-Meier estimates of 6, 12 and 24 months survival of all recipients|Recipient survival was monitored from transplant date until death up to 2 years as in SRTR data file October 2015|All recipients of organs from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis|||percentage of participants|||Number
1374610|NCT01515072|Post-Hoc|Death-Censored Kidney Graft Survival at 6, 12 and 24 Months|kidney graft survival censored for death with functioning graft|Kidney graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015|Included were kidneys transplanted alone or with pancreas. All kidney grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Kidney graft loss is defined as loss of functioning graft or retransplantation during the 24 months post-transplant.|||percentage of participants|||Number
1374611|NCT01515072|Post-Hoc|Graft Survival|Kaplan-Meier estimates of 6, 12 and 24 months survival of all grafts|Graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015|All grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Graft loss is defined as retransplantation or death during the 24 months post-transplant.|||percentage of all grafts|||Number
1374612|NCT01515072|Post-Hoc|Acute Kidney Rejection|Diagnosis of rejection as documented in the recipient records in the Scientific Registry of Transplant Recipients (SRTR).|6 months after kidney transplantation|This outcome was examined in recipients of in SRTR that received kidneys from donors in the RIPNOD trial|||participants|||Number
1374613|NCT01515072|Secondary|Pulsatile Perfusion Parameters|Perfusate resistance (mm Hg/mL/min) in machine perfused kidneys.|Up to 24 hours of machine perfusion||||Resistance, mm Hg/mL/min||Standard Deviation|Mean
1374618|NCT01515072|Secondary|Change in Dynamic Compliance|"Change in dynamic compliance of the lung from before intervention to terminal value~Cdyn = Dynamic compliance; Vt = tidal volume; PIP = Peak inspiratory pressure (the maximum pressure during inspiration); PEEP = Positive End Expiratory Pressure:~Cdyn= Vt/PIP - PEEP"|Subjects will be followed from admission to explantation, an average of 4.5 days||||L/cm H20||Inter-Quartile Range|Median
1374619|NCT01515072|Secondary|Change in P:F Ratio|Change in ratio of arterial oxygen pressure:fraction inspired oxygen ratio from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days||||ratio||Inter-Quartile Range|Median
1374620|NCT01515072|Secondary|Change in Creatinine Clearance|Change in creatinine clearance (mL/min by Cockcroft-Gault method) from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days|Donors in whom two serum creatinine values (one before intervention and another after the initial intervention) are available.|||mL/min||Inter-Quartile Range|Median
1374621|NCT01515072|Secondary|Change in Serum Lactate|Change in serum lactate levels (mg/dL) from before intervention to the final value|Subjects will be followed from admission to explantation, an average of 4.5 days|Donors in whom at least two serum lactate levels (one before and one after the initial intervention) were available|||mg/dL||Inter-Quartile Range|Median
1374622|NCT01515072|Secondary|Change in Vasopressor Score|"Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, arterial oxygen pressure:fraction of inspired oxygen (P:F) ratios, Lung Compliance, Cardiac biomarkers, ejection fraction (EF) from 2-dimensional Echocardiogram.~Here we will present data for the change in vasopressor use evaluated using a vasopressor score.~A numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322):~Vasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100).~The range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor."|Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours|Donors in whom vasopressor agent and dose were described in the OPO records before intervention and prior to aortic cross clamp.|||units on a scale||Inter-Quartile Range|Median
1374623|NCT01515072|Secondary|Number of Organs Transplanted Per Donor|Number of organs transplanted from each organ donor|Within 24 hours of organ recovery|Subjects were organ donors enrolled in this multicenter study|||Organs transplanted from each donor||Standard Deviation|Mean
1374624|NCT01515072|Primary|Number of Organs Recovered Per Donor|Number of organs recovered per organ donor|At time of organ recovery, up to 1 day|Subjects were organ donors enrolled in this multicenter study|||organs recovered per donor||Standard Deviation|Mean
1374625|NCT01515046|Secondary|Ascorbate Levels|Ascorbate levels will be taken at the bottom of each cycle to assess therapeutic dose window.|Once every 28 days up to 5 years|||||||
1374626|NCT01515046|Secondary|F2-isoprostane Levels|F2-isoprostane is a marker of systemic oxidative stress.|Once every 28 days for up to 5 years|Due to n=1 and study termination, the data were not analyzed.||||||
1374627|NCT01515046|Secondary|Number of Drug-related Adverse Events Per Cycle|Adverse events linked to ascorbate will be categorized and quantified using CTCAE v4 at the bottom of each cycle. Incidence and frequency will be compared to scientific literature|every 28 days up to 5 years|Due to n=1 and study termination, the data were not analyzed.||||||
1374628|NCT01515046|Secondary|Progression Free Survival|Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST criteria from NCI.|up to 5 years||||days|||Number
1374629|NCT01515046|Primary|Overall Survival|Time to event outcome measure (death), measured in days from cycle 1 day 1.|up to 5 years||||days|||Number
1374630|NCT01514864|Secondary|Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality|Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 – 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received study drug.|||Participants|||Number
1374631|NCT01514864|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug|||Participants|||Number
1374632|NCT01514864|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug|||Months||90% Confidence Interval|Median
1374633|NCT01514864|Secondary|Progression-free Survival (PFS) Distribution|PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug|||Percentage of participants||90% Confidence Interval|Median
1374716|NCT01514149|Secondary|Fasting Body Weight CFB to Week 18||CFB to Week 18|Completed Population|||kg||Standard Deviation|Mean
1374634|NCT01514864|Secondary|Overall Survival|Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received treatment|||Months||90% Confidence Interval|Median
1374635|NCT01514864|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated.||||||
1374636|NCT01514864|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated.||||||
1374637|NCT01514786|Primary|Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits|Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.|6 months following intervention a chart audit will be conducted to determine if CRCS was completed.||||participants|||Number
1374638|NCT01514760|Secondary|Asthma Control Test™ Scores|"The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5)."|Baseline and eight weeks|All participants and participants with uncontrolled asthma at baseline. The number of participant with uncontrolled asthma 10.|||units on a scale||Standard Deviation|Mean
1374639|NCT01514760|Secondary|Asthma Self-Efficacy for Adolescent Children|"The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from “not at all sure” (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to “completely sure” (5 points). Total score range from 14-70. The higher score represent a greater degree of self-efficacy. The Cronbach’s α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention)."|Baseline and eight weeks||||units on a scale||Standard Deviation|Mean
1374640|NCT01514760|Secondary|Number of Participants That Utilized the Asthma Action Plan|The frequency of utilization of the Asthma Action Plan for acute symptoms among the study population will be measured and compared to responses of daily prompts that will ask participants to record whether they used rescue medication.|Eight weeks||||participants|||Number
1374641|NCT01514760|Primary|Mobile Asthma Action Plan (AAP) Usage|Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements.|Eight weeks||||days per week||Full Range|Median
1374642|NCT01514734|Primary|Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).|Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|8 weeks||||millimeters mercury (mmHg)||Standard Deviation|Mean
1374643|NCT01514682|Secondary|Change in C-Reactive Protein (CRP)|Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.|A cytokine profile will be collected at baseline and at week 12 (end-of-study).|Participants who had a cytokine profile collected.|||ng/ml||Standard Deviation|Mean
1374644|NCT01514682|Secondary|Change in Pro-inflammatory Cytokines|Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.|A cytokine profile will be collected at baseline and at week 12 (end-of-study).|Participants who had a cytokine profile collected.|||pg/ml||Standard Deviation|Mean
1374645|NCT01514682|Secondary|Change in Negative Symptoms|The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Median SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Participants completing the SANS rating assessment.|||units on a scale||Inter-Quartile Range|Median
1374646|NCT01514682|Secondary|Change in Depressive Symptoms|"The Calgary Depression Scale (CDS) total score will be used to measure depressive symptoms. Total score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating."|The CDS was administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Participants completing the CDS assessment rating.|||units on a scale||Inter-Quartile Range|Median
1374647|NCT01514682|Primary|Change in Neuropsychological Test Performance|The MATRICS Consensus Cognitive Battery (MCCB) composite score by week ranging from -10-100 with a higher score indicating a better outcome.|The MCCB was administered at baseline and end-of-study (Week 12).|Participants completing the MCCB testing.|||units on a scale||Inter-Quartile Range|Median
1374648|NCT01514682|Primary|Change in Persistent Positive Symptoms|"The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating."|The BPRS will be administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Participants completing the BPRS assessment rating.|||units on a scale||Inter-Quartile Range|Median
1374649|NCT01514630|Primary|HAMD Rating Scores|"Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.||||Units on a scale||Standard Deviation|Mean
1374650|NCT01514513|Secondary|Adverse Events|Number of participants with adverse events|15 days||||participants|||Number
1374651|NCT01514513|Primary|The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice|No live lice 15 days following initial treatment|15 days||||participants|||Number
1374652|NCT01514461|Secondary|Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death||52 weeks|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
1374653|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)|Average observed blood concentration measured by (AUC0-24)/24.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||ng/mL||Standard Deviation|Mean
1374654|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)||0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||hours||Full Range|Median
1374655|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)|The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment|||ng/mL *hr||Standard Deviation|Mean
1374656|NCT01514461|Secondary|Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax)|Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment|||ng/mL||Standard Deviation|Mean
1374657|NCT01514461|Secondary|Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12|Post prandial peak triglycerides – maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 – area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours|0-24 hours at Baseline, Week 12|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. For each category, the number of randomized patients who have non-missing values are included in this analysis.|||Percent change||95% Confidence Interval|Geometric Mean
1374658|NCT01514461|Secondary|Percent Change From Baseline in Fasting Triglycerides||Baseline, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percent change||95% Confidence Interval|Geometric Mean
1374659|NCT01514461|Secondary|Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds|Percentage of patients reaching target values of <1000 mg/dL or target values of < 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of patients|||Number
1374660|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of participants|||Number
1374661|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of participants|||Number
1374662|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of participants|||Number
1374717|NCT01514149|Primary|Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18||CFB to Week 18|Completed Population|||Percent (%)||Standard Deviation|Mean
1374718|NCT01514136|Primary|Degree of Leakage|"The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.~The scale was developed by Coloplast A/S"|One week||||units on a scale|Participants|Standard Deviation|Mean
1374663|NCT01514461|Primary|Percent Change in Fasting Triglycerides From Baseline to 12 Weeks|Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.|Baseline to 12 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. The number of randomized patients with non-missing fasting triglycerides values at baseline and Week 12 are included in this analysis.|||percent change||95% Confidence Interval|Geometric Mean
1374664|NCT01514448|Secondary|Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months|The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated|48 months|Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated||||||
1374665|NCT01514448|Secondary|Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months|Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact.|48 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||months||80% Confidence Interval|Median
1374666|NCT01514448|Secondary|Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months|Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment|24 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||months||80% Confidence Interval|Median
1374667|NCT01514448|Secondary|Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6|Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions.|Month 6|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||percentage of participants|||Number
1374668|NCT01514448|Primary|Percentage of Progression-free Patients by Month 6|Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.|Month 6|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||Percentage of participants|||Number
1374669|NCT01514422|Secondary|Changes in Young Mania Rating Scale (YMRS)|Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).|baseline and week 8||||units on a scale||Standard Deviation|Mean
1374670|NCT01514422|Secondary|Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan|Measured at baseline and week 8|baseline and week 8||||mmol/L||Standard Deviation|Mean
1374671|NCT01514422|Primary|Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)|Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).|baseline and week 8||||units on a scale||Full Range|Mean
1374672|NCT01514357|Primary|Changes in Systolic Blood Pressure (BP)|The change in BP with treatment over 7 days was assessed by the mean BP on admission, (treatment day 1) mean BP 23 hours after the first injection of BNP, and mean BP 23 hours after the second injection of BNP (treatment day 2). Treatment day 2 was 7 days after admission.|baseline, treatment day 1, treatment day 2||||mmHg||Standard Deviation|Mean
1374673|NCT01514318|Secondary|Harris Hip Score|A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.|10 year||||units on a scale||Standard Deviation|Mean
1374719|NCT01513902|Secondary|Taste Assessment|Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.|Day 1, Day 5|The analysis population was defined as all participants who had received at least 1 oral solution formulation of tofacitinib.|||participants|||Number
1374674|NCT01514318|Secondary|Western Ontario McMaster Arthritis Index (WOMAC)|Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.|10 year||||units on a scale||Standard Deviation|Mean
1374675|NCT01514318|Primary|Survivorship of the Device|The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.|10 year|Subjects who signed the consent form and completed the study paperwork.|||participants|||Number
1374676|NCT01514292|Primary|CGM Relative Differences to Laboratory Reference|The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.|7 days||||Percentage of difference||Standard Deviation|Mean
1374677|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374678|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374679|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374680|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374681|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1375151|NCT01508013|Primary|Indoor Tanning Willingness|Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).|12 months|Adolescent females aged 12-18 years old that expressed interest in indoor tanning in the future.|||units on a scale||Standard Deviation|Mean
1374682|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374683|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374684|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374685|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374686|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374687|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374720|NCT01513902|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.|||hours||Standard Deviation|Mean
1374724|NCT01513902|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1374688|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374689|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374690|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374691|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374692|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374693|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 10|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374721|NCT01513902|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
1374722|NCT01513902|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.|||hours||Full Range|Median
1374694|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 8|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374695|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 4|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374696|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 2|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 – 70), systemic symptom score (5 – 35), emotional function score (12 – 84), social function score (5 – 35) and the total score (32 – 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374697|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
1374698|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
1374699|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
1374700|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
1374701|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
1374702|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
1374703|NCT01514240|Secondary|Cumulative Remission Rate at Week 8|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Percentage of participants||90% Confidence Interval|Number
1374704|NCT01514240|Secondary|Cumulative Remission Rate at Week 4|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Percentage of participants||90% Confidence Interval|Number
1374705|NCT01514240|Secondary|Cumulative Remission Rate at Week 2|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Percentage of participants||90% Confidence Interval|Number
1374723|NCT01513902|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1374735|NCT01513590|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
1374706|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 8|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374707|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 4|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374708|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 2|"Crohn’s Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn’s disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1374709|NCT01514240|Secondary|Remission After 4-week of Treatment|For the secondary efficacy variable “Remission after 4 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Participants|||Number
1374710|NCT01514240|Secondary|Remission After 2-week of Treatment|For the secondary efficacy variable “Remission after 2 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Participants|||Number
1374711|NCT01514240|Primary|Remission After 8-week of Treatment|For the primary efficacy variable “Remission after 8 weeks of treatment”, Crohn’s Disease Activity Index CDAI scores was used to determine the patient’s response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Participants|||Number
1374712|NCT01514162|Secondary|Report the Hemodynamic Performance of the Valve|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.~Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.~Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size."|5 years|Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed assessment|||mmHg||Standard Deviation|Mean
1374713|NCT01514162|Secondary|Characterize Patient NYHA Functional Classification Status|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|5 years|Number of participants analyzed is those subjects with a visit and completed assessment|||participants|||Number
1374714|NCT01514162|Primary|Late Adverse Event Incidence|"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.~Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]"|5 years||||event/100-patient years|||Number
1374715|NCT01514149|Secondary|Time to Hyperglycemia Rescue||18 weeks|Completed Population|||days||Standard Deviation|Mean
1374725|NCT01513902|Primary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1374726|NCT01513902|Primary|Number of Participants With Laboratory Test Abnormalities|Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell[RBC] count:<0.8*lower limit of normal [LLN], platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal[ULN], white blood cell [WBC] count:<0.6*LLN></0>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function (total bilirubin: >1.5*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>3.0*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN);Renal Function (blood urea nitrogen, creatinine:>1.3*ULN, uric acid:>1.2*ULN); Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN);Clinical chemistry (glucose <0.6*LLN or >1.5*ULN, creatine kinase:>3.0*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to [>=] 6/High Power Field [HPF]).|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1374727|NCT01513902|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.|Baseline up to 28 days after the last dose of study drug (Day 5)|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1374728|NCT01513902|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'number of participants analyzed (N)' signifies those participants who were evaluable for this outcome measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
1374729|NCT01513590|Secondary|Number of Treatment Emergent AEs (Adverse Events)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1374730|NCT01513590|Secondary|Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks|Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Data for 15 subjects were excluded, as only subjects exposed for at least 12 weeks were included in this measurement.|||participants|||Number
1374731|NCT01513590|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data were imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
1374732|NCT01513590|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||episodes|||Number
1374733|NCT01513590|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||episodes|||Number
1374734|NCT01513590|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. At baseline 195 subjects each in IDegAsp BID and BIAsp 30 BID treatment group were analysed.|||mmol/L||Standard Deviation|Mean
1374737|NCT01513473|Secondary|Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)|Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)|After 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.|||%B/T||Standard Deviation|Mean
1374738|NCT01513473|Secondary|Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment|Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.|Between week 1 and week 26|Full Analysis Set (FAS) Included all randomised subjects. 1 subject was excluded from the analysis in the IDet arm as he was withdrawn before exposure to trial drug.|||pmol/L||Standard Deviation|Mean
1374739|NCT01513473|Secondary|Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))|Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment|After 26 weeks and 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects|||episodes|||Number
1374740|NCT01513473|Secondary|Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))|Episodes of PG >11.1mmol/L (200mg/dL)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.|||episodes|||Number
1374741|NCT01513473|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 – 07:00] and over the entire day (24 hours)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.|||episodes|||Number
1374742|NCT01513473|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.|||events|||Number
1374743|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 52 weeks of treatment.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks.|||mmol/L||Standard Deviation|Mean
1374744|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks. FPG samples were missing for 9 subjects.|||mmol/L||Standard Deviation|Mean
1374745|NCT01513473|Secondary|Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 52 weeks of treatments.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1374746|NCT01513473|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1374747|NCT01513460|Secondary|Mean Percentage of Days With Performance of Usual Activities|A ‘day able to perform usual daily activities’ was defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of ‘days able to perform usual daily activities’ was derived and analyzed using a similar mixed model as specified for primary analysis as for the percentage of nights with ‘no nighttime awakenings’.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage of days||Standard Error|Mean
1374748|NCT01513460|Secondary|Mean Percentage of Nights With 'no Nighttime Awakenings'|A night with 'no nighttime awakenings' is defined from diary data as any night where patient did not wake up due to symptoms. Total number of nights with 'no nighttime awakenings' over treatment period was divided by total number of nights where diary recordings have been made in order to derive percentage of 'no nighttime awakenings' which will be summarized by treatment and analyzed using a similar mixed model as specified for primary analysis. Diary data recorded during the 7 day run-in period was used to calculate baseline percentage of nights 'no nighttime awakenings'.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage of nights||Standard Error|Mean
1374749|NCT01513460|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use|The total number of puffs of rescue medication used over the last 12 h recorded in the morning (nighttime use) and in the evening (daytime use) over the full 12 weeks was divided by the total number of days with non-missing rescue data to derive the mean daytime and nighttime number of puffs of rescue medication. Change from baseline in the mean daytime and nighttime number of puffs of rescue medication was analyzed as for the change from baseline in the mean daily number of puffs of rescue medication.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.|||puffs of rescue medication||Standard Error|Mean
1374750|NCT01513460|Secondary|Change From Baseline in Total Score of the St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment|SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest is 100. Higher values corresponded to greater impairment in quality of life. An analysis model included terms for treatment, baseline total SGRQ score, FEV1 and baseline smoking status. The model also contained as fixed effects the baseline total SGRQ score, FEV1 prior to inhalation of short acting bronchodilator, FEV1 post inhalation of short acting bronchodilator and stratification factors as covariates. A negative change from baseline indicates improvement.|12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.|||units on a scale||Standard Error|Mean
1374751|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.|||Liters||Standard Error|Mean
1374752|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.|||Liters||Standard Error|Mean
1374753|NCT01513460|Primary|Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 12 weeks|Participants from the per-protocol set (PPS), who had values at both baseline and week 12, were included in the analysis. The PPS included all randomized participants who had at least one dose of study drug and who were without any major protocol or non-protocol deviations.|||liters||Standard Error|Mean
1374754|NCT01513447|Secondary|Total Local Anesthetic Consumption|It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.|24 hours||||milliliters||Standard Deviation|Mean
1374755|NCT01513447|Primary|Number of Participants With Breakthrough Back Labor Pain|It is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.|within 24 hours||||participants|||Number
1374756|NCT01513330|Primary|Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)|Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.|14 days||||points on a scale|Participants|Standard Deviation|Mean
1374757|NCT01513317|Secondary|Median Number of Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) During the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants who completed Week 13 unblinding|||RBC Transfusions||Full Range|Median
1374758|NCT01513317|Secondary|Mean Changes From Baseline in Percentages of Bone Marrow Blast Cells at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13|||Percentage of Bone Marrow Blast Cells||Standard Deviation|Mean
1374759|NCT01513317|Secondary|Percentage of Participants Who Did Not Require a Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) in the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants|||Percentage of Participants|||Number
1374760|NCT01513317|Secondary|Percentage of Participants Achieving Hemoglobin Improvement (≥1.5 g/dL Increase From Baseline) Unrelated to Red Blood Cell (RBC) Transfusion at Week 13||Week 13|Intent-to-treat population: Included all randomized participants|||Percentage of Participants|||Number
1374761|NCT01513317|Secondary|Change From Baseline in the Mean Hemoglobin Concentrations at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13|||g/dL||Standard Deviation|Mean
1374762|NCT01513317|Primary|Percentage of Participants Who Achieved a Reduction in Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS)|Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.|Up to Week 13|Intent-to-treat population: Included all randomized participants|||Percentage of participants|||Number
1375456|NCT01505374|Secondary|Postoperative Complications||Up to postoperative day 2|Analysis of postoperative complications was not performed because sufficient data could not be collected regarding the secondary outcome||||||
1374763|NCT01513291|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Percentage of participants||95% Confidence Interval|Number
1374764|NCT01513291|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Percentage of participants||95% Confidence Interval|Number
1374765|NCT01513291|Secondary|Mean Change From Baseline in Monthly Headache Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Days/month||Standard Error|Least Squares Mean
1374766|NCT01513291|Primary|Percentage of Participants Discontinued From Study Medication Due to an Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.|||Percentage of participants|||Number
1374767|NCT01513291|Primary|Percentage of Participants With One or More Adverse Events|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.|||Percentage of participants|||Number
1374768|NCT01513291|Primary|Mean Change From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Days/month||Standard Error|Least Squares Mean
1374769|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Compromised Immunity|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Compromised immunity is an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|12 weeks|Treated participants with compromised immunity|||Percentage of participants|||Number
1374770|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those 65 Years and Older|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants 65 years and older.|||Percentage of participants|||Number
1375163|NCT01507896|Primary|Safety: Number of Adverse Events Related to BAX326||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||adverse events|treatments with BAX326 before surgery||Number
1374771|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Participants with clinically severe CDI have a Zar Score greater than or equal to 2 points based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2) body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dl (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|12 weeks|Treated participants with clinically severe CDI|||Percentage of participants|||Number
1374772|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. An epidemic strain includes ribotypes 027, 014, 002, 001, 106 or 020.|12 weeks|Treated participants with an epidemic strain|||Percentage of participants|||Number
1374773|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. The 027 ribotype is a more virulent, epidemic strain responsible for several outbreaks of disease associated with an increased risk of severity and mortality.|12 weeks|Treated participants with the 027 ribotype|||Percentage of participants|||Number
1374774|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants with a history of CDI in the past 6 months.|||Percentage of participants|||Number
1374775|NCT01513239|Primary|Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 24 hours|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
1374776|NCT01513239|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
1374777|NCT01513239|Primary|Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
1374778|NCT01513239|Primary|Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
1374779|NCT01513239|Primary|Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK- 3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
1374780|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants who achieved a clinical cure of the initial CDI episode.|||Percentage of participants|||Number
1374781|NCT01513239|Secondary|Percentage of Participants With Global Cure|Global cure is defined as the clinical cure of the initial CDI episode with no CDI recurrence through Week 12. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.|||Percentage of participants|||Number
1374782|NCT01513239|Primary|Percentage of Participants With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The (Full Analysis Set) FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.|||Percentage of participants|||Number
1374783|NCT01513148|Secondary|Temperature (Degrees C)|Change in superficial skin temperature (degrees C) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment||||Degrees Celsius||Standard Deviation|Mean
1374784|NCT01513148|Secondary|Negative Peak Latency (Milliseconds)|Change in negative peak latency (ms) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment||||ms||Standard Deviation|Mean
1374785|NCT01513148|Primary|Nerve Conduction Velocity (Meters Per Second)|Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment||||m/s||Standard Deviation|Mean
1374786|NCT01513122|Secondary|Mean Glucose Changes Over 48 Weeks as Measured by DXA Scan||May 2013||||mmol/L||95% Confidence Interval|Mean
1374787|NCT01513122|Secondary|Mean Total Cholesterol Changes Over 48 Weeks as Measured by DXA Scan||May 2013||||mmol/L||95% Confidence Interval|Mean
1374788|NCT01513122|Secondary|Mean Triglycerides Changes Over 48 Weeks as Measured by DXA Scan||May 2013||||mmol/L||95% Confidence Interval|Mean
1374789|NCT01513122|Secondary|Mean Total Body Fat Changes Over 48 Weeks as Measured by DXA Scan||May 2013||||kg||95% Confidence Interval|Mean
1374790|NCT01513122|Primary|Mean Limbs Fat Changes Over 48 Weeks as Measured by DXA Scan||May 2013||||percentage of limb fat change||95% Confidence Interval|Mean
1374791|NCT01513122|Primary|Mean Bone Mineral Density Changes Over 48 Weeks as Measured by DXA Scan||May 2013||||percentage of BMD change||95% Confidence Interval|Mean
1374792|NCT01512979|Secondary|Change From Baseline in FPG by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC, Observed Cases|||mg/dL||Standard Error|Mean
1374793|NCT01512979|Secondary|Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment|The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.|||participants|||Number
1374794|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.|||participants|||Number
1374795|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.|||participants|||Number
1374796|NCT01512979|Secondary|Change From Baseline in HbA1c by Visit Over Time|HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC (observed cases)|||percent||Standard Error|Mean
1374797|NCT01512979|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment|The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 24 weeks|Patients from PPCC (LOCF)|||mg/dL||Standard Error|Mean
1374798|NCT01512979|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c|Baseline and 24 weeks|Per Protocol completers cohort (PPCC): All patients randomised, treated with at least 1 dose of study drug, with a baseline HbA1c value without important protocol violations and who completed 24 weeks of treatment, were not treated with rescue medication and have an HbA1c measurement after 24 weeks of treatment.|||percent||Standard Error|Mean
1374799|NCT01512849|Primary|Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284|The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC – urinary glucose excretion) on the preceding day and on the day of administration.|For 24 hours after each administration||||percent of RGR at baseline||95% Confidence Interval|Mean
1374800|NCT01512849|Primary|Effect of Renal Function on Urinary Glucose Excretion of TA-7284||For 24 hours after each administration||||g||95% Confidence Interval|Mean
1374801|NCT01512849|Primary|Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284||For 72 hours after each administration||||ng･h/mL||Standard Deviation|Mean
1374802|NCT01512849|Secondary|Clinical Laboratory Tests|Change from baseline in Clinical laboratory tests|For 72 hours after each administration|||||||
1374803|NCT01512849|Secondary|Vital Signs|Change from baseline in Vital signs (BP, PR and BT)|For 72 hours after each administration|||||||
1374804|NCT01512849|Secondary|12-lead Electrocardiogram (ECG)|Change from baseline in ECG parameters|For 72 hours after each administration|||||||
1374805|NCT01512849|Secondary|Adverse Events|Incidence and severity of AEs|Upto approximately 14 days after last administration|||||||
1374806|NCT01512849|Primary|Effect of Renal Function on Maximum Plasma Concentration of TA-7284||For 72 hours after each administration||||ng / mL||Standard Deviation|Mean
1374807|NCT01512797|Secondary|Active GLP-1|Active GLP-1 (Fasting and during a Mixed Meal Test). The Change in Fasting Active GLP-1 refers to the change in fasting active GLP-1 from pre-intervention time point to post-intervention time point. The Change in Peak Active GLP-1 refers to the change in the peak active GLP-1 level from the pre-intervention time point to post-intervention time point.|Pre-Intervention and Post-Intervention||||pmol/L||Standard Deviation|Mean
1374808|NCT01512797|Secondary|Occurrence of Side Effects In Relation to Sitagliptin|Side effects to Sitagliptin or Placebo were measured in study participants via Sigstad score questionnaire, while fasting and periodically during a 3 hour period after drinking a 200 kcal meal drink, before and after intervention. The Sigstad scoring system is based on the participants report of the occurrence of 16 symptoms suggestive of the dumping syndrome. Each symptom is given a different score. For example, desire to sit down (+4), breathlessness (+3), dizziness (+2), nausea (+1), vomiting (-4) etc.The scale can range from -5 to 34. Scores greater than or equal to 7, after glucose intake, are considered diagnostic of dumping syndrome.|6 weeks||||units on Sigstad scale||Standard Deviation|Mean
1374809|NCT01512797|Secondary|Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery|"Satiety levels were measured in study participants while they were fasting and periodically over a three hour period after drinking a 200 kcal meal drink, before and after intervention via a Visual Analog Scale. Participants were asked to mark on a 0 to 150 millimeter scale their response to the following question: How full do you feel right now? with lower scores indicating not full at all and higher scores indicating extremely full."|Baseline and ~4 weeks||||mm||Standard Deviation|Mean
1374810|NCT01512797|Primary|Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test|Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo). AUC was measured by trapezoidal method.|Baseline and ~4 weeks||||mmol/L/min||Standard Deviation|Mean
1374811|NCT01512797|Primary|Change in Postprandial Glucose Levels After Mixed Meal Test|Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo).|Baseline and ~4 weeks|All patients completed study in both arms.|||mmol/L||Standard Deviation|Mean
1374812|NCT01512745|Secondary|Percentage of Participants With Adverse Events||30 months||||percentage of participants|||Number
1374813|NCT01512745|Secondary|Objective Response Rate(ORR)|Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)|30 months||||percentage of participants|||Number
1374814|NCT01512745|Secondary|Disease Control Rate(DCR)|Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.|30 months||||percentage of participants|||Number
1374815|NCT01512745|Primary|Overall Survival(OS)|Overall Survival of the Participants|30 months||||month||95% Confidence Interval|Median
1374816|NCT01512745|Primary|Progression Free Survival(PFS)|Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|30 months||||month||95% Confidence Interval|Median
1374817|NCT01512693|Secondary|Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose|Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Standard Deviation|Mean
1375457|NCT01505374|Secondary|Rating the Success of the Nerve Blocks||Up to postoperative day 2|The success of nerve blocks was not collected or analyzed. Instead, muscle strength was collected (data are presented in another table).||||||
1374818|NCT01512693|Secondary|Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Full Range|Median
1374819|NCT01512693|Secondary|Maximum Concentration (Cmax) of MK-0822 After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
1374820|NCT01512693|Primary|Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||μM*hr||95% Confidence Interval|Least Squares Mean
1374821|NCT01512667|Secondary|Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Geometric Coefficient of Variation|Geometric Mean
1374822|NCT01512667|Secondary|Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Full Range|Median
1374823|NCT01512667|Secondary|Maximum Concentration (Cmax) of MK-0822 After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
1374824|NCT01512667|Primary|Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||μM*hr||95% Confidence Interval|Least Squares Mean
1374825|NCT01512368|Secondary|Change From Baseline Fasting Glucose Acutely and at Two Weeks|Serum measurement of glucose was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||mg/dL||Standard Deviation|Mean
1374826|NCT01512368|Secondary|Change From Baseline Total Adiponectin Acutely and at Two Weeks|Serum measurement of total adiponectin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||ng/mL||Inter-Quartile Range|Median
1374827|NCT01512368|Secondary|Change From Baseline Leptin Acutely and at Two Weeks|Serum measurement of leptin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||ng/mL||Inter-Quartile Range|Median
1374828|NCT01512368|Secondary|Change From Baseline Epinephrine Acutely and at Two Weeks|Serum measurement of epinephrine was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report (5), we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||pg/mL||Inter-Quartile Range|Median
1375187|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1374829|NCT01512368|Secondary|Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks|Serum measurement of free fatty acids (FFAs) was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||mg/dL||Inter-Quartile Range|Median
1374830|NCT01512368|Primary|Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks|Serum measurement of FGF21 using human ELISA kit was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated. All participants were analyzed.|||ng/L||Inter-Quartile Range|Median
1374831|NCT01512251|Secondary|Secondary Outcome 6 Phase 2 - MAPK Pathway Gene Expression Levels|Responding tumors lack gene expression signatures of MAPK pathway activation, and progressing tumors demonstrate gene expression signatures of MAPK pathway activation - determined by laboratory tests and tumor assessments.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
1374832|NCT01512251|Secondary|Secondary Outcome 5 Phase 2 - PI3K Pathway Gene Expression Levels|Responding tumors lack gene expression signatures of PI3K pathway activation, and progressing tumors demonstrate gene expression signatures of PI3K pathway activation - determined by laboratory tests and tumor assessments.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
1374833|NCT01512251|Secondary|Secondary Outcome 4 Phase 2 - PI3K-pathway Signaling Reduction Levels|Greater reduction in PI3K-pathway signaling associated with better PFS determined by laboratory tests and tumor assessments.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
1374834|NCT01512251|Secondary|Secondary Outcome 3 Phase 2 - PTEN Expression|PTEN expression associated with better PFS determined by laboratory tests.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
1374835|NCT01512251|Secondary|Secondary Outcome 2 Phase 2 - Safety and Tolerability|Determined by clinical and laboratory tests, and AE assessments|During study treatment, up to 2 years|Data not collected: study was terminated early due to dose limiting toxicities.||||||
1374836|NCT01512251|Secondary|Secondary Outcome 1 Phase 2 - Objective Response Rate|"Objective response rate determined by tumor assessments, clinical tests and laboratory tests.~Data not collected: study was terminated early due to dose limiting toxicities."|Day 28 (+/- 3) of even-numbered treatment cycles until progression|||||||
1374837|NCT01512251|Primary|Phase 2 - Progression-free Survival Rate|6 month progression-free survival rate (PFS6) determined by tumor assessments, clinical tests and laboratory tests|6 months|Data were not collected, study never advanced to Phase II.||||||
1374838|NCT01512251|Primary|Phase 1 - Safety & Recommended Phase 2 Dose (RP2D)|RP2D determined by MTD, post-DLT period toxicity, and pharmacokinetic data|28 days||||mg|||Number
1374839|NCT01512225|Secondary|Provision of Breast Milk at 6 Weeks Post Term Gestation|Provision of breast milk at 6 weeks post term gestation as primary source of nutrition|6 weeks post term gestation||||Participants|||Count of Participants
1374840|NCT01512225|Secondary|Provision of Breast Milk at Term Gestation|provision of breast milk as the primary source of nutrition|term gestation||||Participants|||Count of Participants
1374841|NCT01512225|Secondary|Mean Volume Change on the Volume of Milk From Day 15 to Day 28|change on the volume of milk from day 15 to day 28 between the two groups|day 15 and day 28||||millilitres||Full Range|Mean
1374842|NCT01512225|Secondary|Mean Volume Change From Day 0 to Day 14|change on the volume of milk from day 0 to day 14 between the two groups|days 0 and 14||||millilitres||Full Range|Mean
1374843|NCT01512225|Secondary|Mean Breast Milk Volumes on Day 28|Mean milk volumes between the two groups at 28 days of study intervention|day 0 and 28||||millilitres||Standard Deviation|Mean
1374844|NCT01512225|Secondary|Mean Breast Milk Volumes on Day 14|Mean milk volumes between the two groups at 14 days of study intervention|Day 0 and day 14||||millilitres||Standard Deviation|Mean
1374845|NCT01512225|Secondary|Increase in Breast Milk Volume on Day 28|Number of mothers who achieved 50% increase in milk volume on day 28|day 0 to day 28||||Participants|||Count of Participants
1374846|NCT01512225|Primary|Increase in Breast Milk Production|The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).|Day 0 to day 14||||Participants|||Count of Participants
1374847|NCT01512160|Secondary|Supine Pulse Rate|Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.|||beats per minute||Standard Deviation|Mean
1374848|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.|||beats per minute||Standard Deviation|Mean
1374873|NCT01512108|Secondary|Change in FPG From Baseline to Week 52|Estimated mean change from baseline in FPG after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.|||mmol/L||Standard Error|Mean
1374849|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia’s formula (QTcF = QT divided by cube root of RR interval).|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.|||milliseconds||Standard Deviation|Mean
1374850|NCT01512160|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)|Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.|||mmHg||Standard Deviation|Mean
1374851|NCT01512160|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormality|Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1374852|NCT01512160|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1374853|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||mcg*hr/mL||Standard Deviation|Geometric Mean
1374854|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||microgram*hour per milliliter (mcg*h/mL)||Standard Deviation|Geometric Mean
1374855|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||hours||Full Range|Median
1374856|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
1374857|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1374858|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1374859|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||hours||Full Range|Median
1374860|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1374861|NCT01512160|Secondary|Participant Satisfaction Questionnaire|Participant's response to 2 questions about “how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)” was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.|||participants|||Number
1375458|NCT01505374|Secondary|Duration of Motor and Sensory Blockade||Up to postoperative day 2|The duration of motor and sensory blockade was not calculated and analyzed, because accurate data regarding block resolution time could not be acquired from patients.||||||
1374862|NCT01512160|Secondary|Participant Global Evaluation of Study Medication|Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.|||participants|||Number
1374863|NCT01512160|Secondary|Number of Participants With Rescue Medication|Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||participants|||Number
1374864|NCT01512160|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.|1.5 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||hours||90% Confidence Interval|Median
1374865|NCT01512160|Secondary|Time to Onset of First Meaningful Pain Relief (PR)|Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||hours||90% Confidence Interval|Median
1374866|NCT01512160|Secondary|Time to Onset of First Perceptible Pain Relief (PR)|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||hours||90% Confidence Interval|Median
1374867|NCT01512160|Secondary|Total Pain Relief (TOTPAR) Score From 0 to 24 Hours|TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF.|||units on a scale*hour||Standard Error|Least Squares Mean
1374868|NCT01512160|Secondary|Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.|0 to 6, 0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF.|||units on a scale*hour||Standard Error|Least Squares Mean
1374869|NCT01512160|Secondary|Time-specific Pain Intensity Difference (PID) Score|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.|15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Standard Deviation|Mean
1374870|NCT01512160|Secondary|Time-specific Pain Relief (PR) Score|PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.|0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Standard Deviation|Mean
1374871|NCT01512160|Secondary|Number of Participants With Peak Pain Relief (PPR)|PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||participants|||Number
1374872|NCT01512160|Primary|Total Pain Relief (TOTPAR) Score From 0 to 6 Hours|TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 6 hours|Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).|||units on a scale*hour||Standard Error|Least Squares Mean
1374874|NCT01512108|Secondary|Change in HbA1c From Baseline to Week 52|Estimated mean change in HbA1c from baseline after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.|||percentage of glycosylated haemoglobin||Standard Error|Mean
1374875|NCT01512108|Secondary|Number of Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).|Week 0 to Week 52|Safety analysis set includes all subjects who received at least one dose of the trial product.|||episodes|||Number
1374876|NCT01512108|Primary|Incidence of Treatment Emergent Adverse Events (AEs)|Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.|Week 0 to Week 52 + 7 days|Safety analysis set included all subjects who received at least one dose of the trial product.|||Events/100 years of patient exposure|||Number
1374877|NCT01511978|Secondary|Self-assessment of LEMS-related Weakness, W-SAS|The last post-dose self-assessment of LEMS-related weakness from the withdrawal period with categories of much much weaker (-3), much weaker (-2), somewhat weaker (-1), about the same (0), somewhat stronger (1), much stronger (2), and much much stronger (3).|Participants were followed for up to 7 days||||units on a scale||Standard Deviation|Mean
1374878|NCT01511978|Primary|Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline|"The 3TUG time obtained 2 hours after the last dose of the withdrawal period (i.e., at time of theoretical “peak drug effect”) was compared to the average time-matched 3TUG tests performed during 2 days of baseline observation prior to randomization.~The study endpoint was a change of more than 30% in the final post-dose 3TUG during the withdrawal period and was based on blinded readings of video recordings of 3TUG tests."|Baseline period (days 0, 1, 2); Randomized treatment period (starting with last dose of day 2, and days 3, 4, 5, and ending with first dose on day 6 when pre-randomization regimen was resumed, or rescue, if indicated sooner)||||Participants|||Count of Participants
1374879|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation|Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"For this analysis, the subject who was taking warfarin and aspirin was included in both the Pennsaid, warfarin group and the Pennsaid, aspirin and/or clopidogrel group, and the subject who was taking dabigatran and aspirin was included in both the Pennsaid, dabigatran group and the Pennsaid, aspirin and/or clopidogrel group."|||Seconds||Full Range|Mean
1374880|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)|PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."|||Seconds||Full Range|Mean
1374881|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)|INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."|||ratio||Full Range|Mean
1374882|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)|PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."|||seconds||Full Range|Mean
1374883|NCT01511809|Secondary|Efficacy and Safety|"Proportion of pts with confirmed virological and treatment failure at w96. Change in CD4 cell counts.~Occurrence of viral resistance to atazanavir in pts with confirmed virologic failure.~Proportion of pts with adverse events, with ≥grade 2 adverse events or abnormal laboratory tests, proportion of pts with side effects leading to discontinuation.~Body fat redistribution and vertebral and femoral bone mineral density. Adherence changes; changes in HIV-associated neurocognitive disorders. Difference in levels of activated Tcells and pro-inflammatory cytokines between treatment groups."|week 96|||||||
1374884|NCT01511809|Primary|Proportion of Patients With Treatment Failure (TF)|Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA <50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success).|Up to week 48||||percentage of patients|||Number
1375459|NCT01505374|Secondary|Patient Satisfaction With Nerve Blocks|Rated on a 0-10 scale, with a higher score representing greater satisfaction.|Up to postoperative day 1||||units on a scale||Standard Deviation|Mean
1374886|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)|Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval.|0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||ng*h/mL||Standard Deviation|Mean
1374887|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||hour||Full Range|Median
1374888|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||ng/mL||Standard Deviation|Mean
1374889|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||L/m^2||Standard Deviation|Mean
1374890|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||L/h/m^2||Standard Deviation|Mean
1374891|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||hour||Standard Deviation|Mean
1374892|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose|5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||ng*h/mL||Standard Deviation|Mean
1374893|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on pharmacokinetic (PK) population which included all participants who received at least 1 treatment. Pre-dose samples from 3 participants of Phase 2, were above lower limit of quantification (LLOQ) (1.00 ng/mL). Hence, those participants were excluded from analysis.|||ng/mL||Standard Deviation|Mean
1374894|NCT01511536|Secondary|Phase 2: Overall Survival|Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|From baseline up to death or study cut-off (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.|||months||95% Confidence Interval|Median
1374895|NCT01511536|Secondary|Phase 2: Percentage of Participants With Objective Response|Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters).|Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)|Efficacy/activity population. Number of participants analyzed=participants with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
1374896|NCT01511536|Secondary|Phase 2: PSA Progression Free Survival|"Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.~Analysis was performed by Kaplan Meire method."|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.|||months||95% Confidence Interval|Median
1374897|NCT01511536|Secondary|Phase 2: Objective Progression Free Survival (PFS)|"Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:~1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.~Analysis was performed by Kaplan-Meier method."|From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5|Analysis was performed on efficacy/activity population.|||months||95% Confidence Interval|Median
1375217|NCT01507246|Secondary|Incidence of Predefined Opioid-related Adverse Events|The incidence of predefined opioid-related adverse events|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner|Per protocol.|||Number of patients|||Number
1374898|NCT01511536|Primary|Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population included all participants who had received at least 2 cycles of the study drug in Phase 2, and had a baseline and at least one post-baseline assessment for the efficacy variable of interest.|||percentage of participants||95% Confidence Interval|Number
1374899|NCT01511536|Primary|Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate|MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.|Up to Cycle 2 of Phase 1 (up to 42 days)|Analysis was performed on DLT evaluable population defined as all participants who received the first 2 cycles, unless they discontinued the study drug during the first 2 cycles for a DLT.|||mg/m^2|||Number
1374900|NCT01511445|Secondary|Fusion Status|Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.|3 mo., 6mo., 12 mo., 24 months|Patients with 24 month films|||Participants|||Count of Participants
1374901|NCT01511445|Primary|Neck Disability Index|The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.|24 months post-op|Patients who had data from 24 month follow-up visit|||units on a scale from 0 to 100||Standard Deviation|Mean
1374902|NCT01511315|Secondary|Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36|The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).|||percentage of participants|||Number
1374903|NCT01511315|Secondary|Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36|The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).|||percentage of participants|||Number
1374904|NCT01511315|Secondary|Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline|The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
1374905|NCT01511315|Secondary|Change in Psoriasis Quality of Life – 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline|The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient’s own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
1374906|NCT01511315|Secondary|Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline|The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)|Baseline, 36 Weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Deviation|Mean
1374982|NCT01510457|Primary|Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10)|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on the depression scale||Standard Deviation|Mean
1374907|NCT01511315|Secondary|Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline|The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 12 and 24 weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
1374908|NCT01511315|Primary|Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.|The PGWB is a self-administered validated psychometric instrument that measures a person’s emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 36 weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
1374909|NCT01511250|Secondary|Number of Participants With Confirmed Dengue Fever|Dengue fever was assessed in participants who had 3 consecutive days of fever >38°C and tested positive for dengue virus by polymerase chain reaction (PCR) analysis.|Day 1 to Day 1080|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).|||participants|||Number
1374910|NCT01511250|Secondary|Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes||Day 28 and Day 90 (Parts 1 and 2) and Days 120, 180, 360, 720 and 1080 in Part 1|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||fold rise||95% Confidence Interval|Geometric Mean
1374911|NCT01511250|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes|GMTs were assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, and TDV-4.|Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1|"The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received. Here n is the number of participants with microneutralizing (MN) assay samples."|||titer||95% Confidence Interval|Mean
1374912|NCT01511250|Secondary|Seroconversion Rate to Each of the Four Dengue Serotypes|Seroconversion rate was defined as the percentage of participants with microneutralization test 50% (MNT50) titer ≥10 or, if the titer on Day 0 was ≥10, a 4-fold rise in antibody titer.|Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||percentage of participants||95% Confidence Interval|Number
1374913|NCT01511250|Secondary|Seropositivity Rate to Each of the Four Dengue Serotypes|Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 and seronegative was defined as titre value of less than (<) 10. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.|Day 28 and Day 90 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||percentage of participants||95% Confidence Interval|Number
1374914|NCT01511250|Secondary|Part I: Titers of Vaccine Viremia||Days 0, 7, 14, 90, 97, and 104|Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.||||||
1374915|NCT01511250|Secondary|Part I: Duration of Vaccine Viremia||Days 0, 7, 14, 90, 97, and 104|Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.||||||
1374916|NCT01511250|Secondary|Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination|Vaccine viremia was assessed for each of the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4 for Part-1. Vaccine viral ribonucleic acid (RNA) was detected by a quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay.|Days 0, 7, 14, 90, 97, and 104|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||participants|||Number
1374917|NCT01511250|Primary|Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120|Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 for any serotype and seronegative was defined as titre value of less than (<) 10 for all 4 serotypes. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.|30 days after second vaccination (Day 120)|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample has been received.|||percentage of participants||95% Confidence Interval|Number
1375218|NCT01507246|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|per protocol|||dollars||Standard Deviation|Mean
1374918|NCT01511250|Primary|Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The severity of all unsolicited AEs was evaluated by the Investigator (using the Common Terminology Criteria for Adverse Events [CTCAE] v4.03) as follows. Mild (Grade 1): Transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): Marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities.|Unsolicited AEs were collected within 28 days of all vaccinations. Serious AEs were collected throughout the study up to Day 1080|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).|||participants|||Number
1374919|NCT01511250|Primary|Number of Participants With Any Solicited AE Following Either Vaccination Dose|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited local injection site reactions included pain, itching, erythema, edema and solicited systemic AEs include myalgia, arthralgia, eye pain, photophobia, fatigue, body rash, nausea, vomiting, and fever.|Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).|||participants|||Number
1374920|NCT01511250|Primary|Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary–Recorded) Following Either Vaccination Dose by Severity|Solicited systemic AEs (headache, muscle pain [myalgia], joint pain [arthralgia], eye pain, sensitivity to light [photophobia], tiredness [fatigue], body rash, nausea, were recorded in the participant’s-diary along with vomiting [number of times]), and body temperature). Diary-recorded severity grades were based on the Common Terminology Criteria for Adverse Events (CTCAE). Severity grades were: Mild (Grade 1): transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): marked symptoms, moderate interference with participant’s daily activities. Severe (Grade 3): Considerable interference with participant’s daily activities. The CTCAE severity grades for fever and vomiting were derived from the diary-recorded measurements of temperature level and number of episodes, respectively.|Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.|||participants|||Number
1374921|NCT01511250|Primary|Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity|Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).|Within 28 days after either of the vaccination given on Day 0 or 90 (Day 28 for first vaccination, Day 118 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.|||participants|||Number
1374922|NCT01511250|Primary|Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity|Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).|Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.|||participants|||Number
1374923|NCT01511107|Secondary|The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product|Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.|||participants|||Number
1374924|NCT01511107|Secondary|The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.|||participants|||Number
1374983|NCT01510457|Primary|Pain Disability Index (PDI)|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on a disability scale||Standard Deviation|Mean
1374984|NCT01510457|Primary|Pain Anxiety Symptoms Scale (PASS)|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on an anxiety scale||Standard Deviation|Mean
1374925|NCT01511107|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14|"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. The parent rated each of these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2, and recorded the ratings in a diary. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. For instances in which the participant was declared a treatment failure, scores are included up to, but not including the day of the failure. Otherwise, scores day 6 to day 14 are included."|From day 6 of administration of study product until day 14 for all episodes|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score from day 6 of administration of study product to day 14. The scores were based on diaries completed at home by the child's parent.|||AOM-SOS score||Standard Deviation|Mean
1374926|NCT01511107|Secondary|The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season|Systemic antibiotics include the study product, Amoxicillin-Clavulanate, dispensed for either 10 or 5 days and various concomitant medications, i.e. Amoxicillin, Amox/Clav, Azithromycin, Cefdinir, Cefpodoxime, Ceftriaxone, Erythromycin, Trimethoprim-Sulfamethoxazole, Omnicef, Augmentin, Azithromycin, Cefazolin, Clarythromycin and Ciprofloxacin.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible.|||days||Standard Deviation|Mean
1374927|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses by the number of months of follow-up."|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.|||recurrences/relapses per months followed||Standard Deviation|Mean
1374928|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses within 60 days of enrollment by the number of months of follow-up within 60 days of enrollment."|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.|||recurrences/relapses per month||Standard Deviation|Mean
1374929|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children completing the study.|||participants|||Number
1374930|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up greater than or equal to day 60.|||participants|||Number
1374931|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.|||recurrence|Recurrences||Number
1374932|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.|||participants|||Number
1374933|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.|||recurrence|Recurrences||Number
1375219|NCT01507246|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|Per protocol|||mg||Standard Deviation|Mean
1374934|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.|||participants|||Number
1374935|NCT01511107|Secondary|The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children with at least one follow-up, nonillness visit, with a nasopharyngeal (NP) culture which is either positive (+) for >=1 penicillin nonsusceptible pathogens or positive (+) only for >=1 penicillin susceptible pathogens or pathogen negative (-).|||Visit|Visits||Number
1374936|NCT01511107|Secondary|The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 365|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is either pathogen negative or positive only for >=1 susceptible pathogen and a NP culture at some time over the course of followup.|||participants|||Number
1374937|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) for >=1 nonsusceptible pathogen & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||recurrence|Recurrences||Number
1374938|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.6.|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is positive (+) for one or more nonsusceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||participants|||Number
1374956|NCT01510834|Secondary|Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)|The PHQ-9 is the self-administered depression module of the Patient Health Questionnaire that assesses common mental disorders. Eight of the 9 items in the scale are included in the Depression Prevention Assessment and is also known as the PHQ-8. Item 9, which assesses suicidality has been omitted in the online version. The PHQ-8 has been shown to have a sensitivity of 81% and specificity of 99% for scores 15 and above in diagnosing major depression, with a positive predictive value of 94%. Scores range from 0 to 24 (0-3 points per question multiplied by 8 questions), with 0-9 indicating no depression, 10-14 minor depression, 15-19 moderately severe major depression, and >19 indicating sever major depression. An initial drop of 5 points is considered adequate treatment response for 3 counseling sessions over 4-6 weeks. A higher score indicates more depression, so a reduction in score from baseline (T1) to 3-month follow-up (T3) is a better outcome.|Change in PHQ-8 score from baseline (T1) to final 3 mos. follow-up (T3)|Those participants who completed all 3 time points.|||units on a scale||Standard Deviation|Mean
1374939|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.9.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) only for one or more susceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||recurrence|Recurrences||Number
1374940|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.2.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is positive only for >=1 susceptible pathogen & a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||participants|||Number
1374941|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||recurrence|Recurrences||Number
1374942|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.3.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||participants|||Number
1374943|NCT01511107|Secondary|The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit|"Proportion of AOM recurrences resulting in treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of the recurrence, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the AOM recurrence was diagnosed until day 21 of the recurrence. The mean day for this visit was 13.3.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit following an AOM recurrence.|||recurrence|Recurrences||Number
1374979|NCT01510652|Secondary|Percentage of Cardiac Resynchronization Therapy Responders|Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)|Baseline and 6 months|The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable)|||% of patients that are CRT responders|||Number
1375460|NCT01505374|Secondary|Preoperative and Postoperative Thigh Muscle Strength in Both Legs|This was measured with a dynamometer to gauge strength.|Up to postoperative day 2||||kilogram-force unit||Standard Deviation|Mean
1374944|NCT01511107|Primary|The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM|"Proportion of children initially diagnosed with AOM who experience treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of randomization, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the tympanic membrane (TM) or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2.|The analysis was intent to treat (ITT). The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit.|||participants|||Number
1374945|NCT01511081|Secondary|Treatment Response|Prospective assessment of positron emission tomography (PET) standardized uptake value (SUV) changes as a measure of treatment response and outcomes. Pulmonary function changes as a function of treatment and response.|2 years|Early study termination. Inadequate enrollment and study period to complete analysis per protocol.||||||
1374946|NCT01511081|Primary|Summary of 2-Year Stereotactic Body Radiotherapy (SBRT) and Stereotactic Body Proton Therapy (SBPT) Related Toxicities by Grade 3+ Treatment-related Toxicity|Outcome defined as 2-year rate of stereotactic body radiotherapy (SBRT)- and SBPT-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, including: radiation-induced pneumonitis/fibrosis/fistula, esophagitis/stricture/fistula.|2 years|Early study termination. Inadequate enrollment and study period to complete analysis per protocol.||||||
1374947|NCT01511016|Primary|Rate of Net Lipolysis|Rate of net lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment|||mmol FFA/kg/h||Standard Error|Mean
1374948|NCT01511016|Secondary|Insulin Levels After Oral Glucose Challenge.|An oral glucose tolerance test was performed to measure endogenous insulin response. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a clinical test of endogenous insulin response to glucose i.e., an endocrine test. Although multiple time points are used in this test, the outcome is a single value, i.e., an area-under-the-curve for insulin.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.|||microU/mL||Standard Error|Mean
1374949|NCT01511016|Secondary|Glucose Levels After Glucose Challenge|An oral glucose tolerance test was performed. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a standard clinical test of glucose tolerance. i.e., a test for diabetes and pre-diabetes. Although multiple time points are used in this test, the outcome is a single value, either a blood glucose level after 2 hours or an area-under-the-curve. In this study we are reporting the area-under-the-curve.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.|||mg/dL||Standard Error|Mean
1374950|NCT01511016|Secondary|Fasting Plasma Non-HDL-C|Fasting plasma non-HDL-cholesterol was calculated from measured total cholesterol and HDL cholesterol.|4 months after treatment.|Number of subjects in each group remaining after 4 months of treatment.|||mg/dL||Standard Error|Mean
1374951|NCT01511016|Secondary|Rates of Fatty Acid Oxidation|Rates of fatty acid oxidation were measured in breath samples following stable isotope infusions of 13C-labeled palmitate.|4 months after treatment|Number of subjects in each group remaining at the end of 4 months of treatment.|||mmol FFA/kg/h||Standard Error|Mean
1374952|NCT01511016|Primary|Rate of Total Lipolysis|Rate of total lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment.|||mmol FFA/kg/h||Standard Error|Mean
1374953|NCT01510912|Other Pre-specified|Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination||||units on a scale||Standard Deviation|Mean
1374954|NCT01510912|Other Pre-specified|Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination||||units on a scale||Standard Deviation|Mean
1374955|NCT01510912|Primary|Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.|Baseline to Week 52/Early Termination||||participants|||Number
1374980|NCT01510652|Primary|Lead Performance|"Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.~Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off."|6 months||||% of patients with freedom from event|||Number
1374957|NCT01510834|Secondary|Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)|The PSS is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in the past month. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are of a general nature and relatively free of content specific to any subpopulation. Internal consistency reliability of the PSS has been shown to be moderate (Cronbach alpha coefficient =.78) and that it has good test-re-test reliability. Scores can range from 0-40 as items are scored 0-4 points each. A higher score indicates more stress, so a negative change from baseline (T1)to 3-month follow-up (T3) is a better outcome.|Change in PSS score from baseline (T1) to final 3 mos. follow-up (T3)|All participants completing all 3 time points of the study.|||units on a scale||Standard Deviation|Mean
1374958|NCT01510834|Secondary|Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)|"The QOLS contains 16 items that represent five conceptual domains of quality of life. QOLS was developed with more consideration to cultural diversity and individual perspectives than other commonly used measures. It uses a unique 7-item Likert scale that allows responses regarding different aspects of life to range from delightful to terrible. It has been found to be internally consistent with alpha from .82 to .92 and showed high test-retest reliability over 3-weeks (r = 0.78 to r = 0 .84). The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Previous validation research showed that patients who participated in a treatment program and rated their symptoms as improved by 60% or gained on average 7 to 8 points on the QOLS total score. A higher QOLS score indicates better quality of life, therefore, a positive score change is a better outcome."|Change in QOLS score from baseline (T1) to final 3 mos. follow-up (T3)|Participants completing all 3 study time points.|||units on a scale||Standard Deviation|Mean
1374959|NCT01510834|Primary|Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)|Developed by researchers at the VA National Center for PTSD, PCL is a self-report questionnaire that consists of 17 questions that map directly onto DSM-IV criteria for PTSD. Respondents are asked how often they have been bothered by each symptom in the past month on a 5-point Likert scale (1=not at all to 5=extremely). Previous research has shown internal consistency coefficients were high for the total scale (.97) and for each subscale (.92 - .93). Test-retest reliability over 2-3 days was shown to be .96. Scores can range from 17-85, with a score of 48 typically indicating PTSD in military populations. The National Center for PTSD recommends using 5 points as a minimum threshold for determining whether an individual has responded to treatment and 10 points as a minimum threshold for determining whether the improvement is clinically meaningful. A higher score indicates more PTSD symptoms, therefore, a score reduction from T1 to T3 is a better outcome than an increase.|Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3)|57 completing all time points for intervention and assessment.|||units on a scale||Standard Deviation|Mean
1374960|NCT01510769|Secondary|Quality of Life|Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient’s level of functional ability with items scores ranging from 0-3 with 0 being the least disability.|12 Months|Intent-to-Treat Population|||Proportion of Subjects|||Number
1374961|NCT01510769|Secondary|Complete or Partial Response of at Least One Tophus|Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12|12 Months|Intent-to-Treat Population|||Proportion of Subjects|||Number
1374962|NCT01510769|Secondary|Complete Resolution of at Least One Target Tophus|Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12|12 Months|Intent-to-Treat Population|||Proportion of Subjects|||Number
1374963|NCT01510769|Primary|Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6|Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6|6 months, analysis after all subjects complete 12 months|Intent-to-Treat Population|||Proportion of Subjects|||Number
1374964|NCT01510756|Secondary|Safety and Tolerability|Frequency, severity and relatedness of adverse events|3 months|zero participants analyzed due to termination of study||||||
1374965|NCT01510756|Secondary|To Determine the iwCLL-WG Defined Overall Response Rate (ORR) - Complete Response (CR) and Partial Responses (PR) to 3 Cycles of Sorafenib Therapy and Following the Completion of All Therapy.|A response assessment must be performed 2 months following completion of therapy to document responses, including a bone marrow if in clinical response (CR) and a computed tomography (or magnetic resonance imaging scan [MRI]) if initial imaging was abnormal or physical examination inconclusive.|Two months following completion of treatment with sorafenib according to iwCLL guidelines.|zero participants analyzed due to termination of study||||||
1374966|NCT01510756|Primary|Overall Response Rate|Determination of absolute lymphocyte count (ALC), lymphadenopathy, splenomegaly, and/or marrow leukemia as measured by 4-color flow minimal residual disease (MRD) panel after 3 cycles of study treatment. (Decrease in absolute lymphocyte count by 50%, decrease in lymphadenopathy (sum of lymph node product) by 50%, decrease in splenomegaly by 50%, or decrease in leukemia infiltration of the bone marrow by 50%.)|3 months|Zero participants analyzed due to termination of study||||||
1374967|NCT01510717|Primary|Mesopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
1374981|NCT01510457|Primary|Pain Visual Analogue Scale|Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on a 100mm pain scale||Standard Deviation|Mean
1375461|NCT01505374|Secondary|Tracking Total Opioid Usage||Up to postoperative day 2||||milligrams||Standard Deviation|Mean
1374968|NCT01510717|Primary|Mesopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
1374969|NCT01510717|Primary|Photopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
1374970|NCT01510717|Secondary|Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses for seeing objects up close?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.|||participants|||Number
1374971|NCT01510717|Secondary|Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses overall?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.|||participants|||Number
1374972|NCT01510717|Secondary|Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180|VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.|||logMAR|Participants|Standard Error|Mean
1374973|NCT01510717|Secondary|Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180|VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.|||logMAR|Participants|Standard Error|Mean
1374974|NCT01510717|Primary|Photopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
1374975|NCT01510717|Primary|Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180|Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.|Day 0 first operative eye visit, up to Day 120-180 from second eye implantation|This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).|||adverse events|Participants||Number
1374976|NCT01510717|Primary|Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180|Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.|||logMAR|Participants|Standard Error|Mean
1374977|NCT01510704|Primary|Post-operative Nausea or Vomiting||24 hours|ITT|||participants|||Number
1374978|NCT01510652|Secondary|Implant Duration|This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.|Total duration of the implant procedure reported at the end of the procedure|The number of participants analyzed is the number of patients with implant data duration time available.|||min||Standard Deviation|Mean
1374985|NCT01510457|Primary|PamSys Actigraph Data|We used a body worn sensor (PAMSys™, Biosensics, LLC, MA)(25-27) embedded in a comfortable t-shirt at the sternal level. Participants wore the PAMSys after the visit for 48 hours. The device provides values related to subjects spontaneous physical activity including percentage of time standing and walking. These variables provide different indexes of participants’ level of activity and activity organization, and were reported by subjects with KOA pain as relevant.|48 hours after visit 3||||percentage of activity (over 48 hours)||Standard Error|Mean
1374986|NCT01510457|Secondary|Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day|Averages of daily diary outcomes were taken over the first and last week of the trial (week 1 and week 11) to compare pre and post treatment. diary was filled out 3 times a day and asked subjects to rate pain at rest, pain when walking, and fatigue on a scale 0-10 (0=none, and 10=the worst)|electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11||||units on a 0-10 NRS scale||Standard Deviation|Mean
1374987|NCT01510457|Primary|McGill Pain Questionnaire – Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on a pain scale||Standard Deviation|Mean
1374988|NCT01510379|Secondary|Quantify the Amounts of Phenergan Used Between the Two Groups.||one week||||mg||Standard Deviation|Mean
1374989|NCT01510379|Primary|Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.|Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).|24 hours||||units on a scale||Standard Deviation|Mean
1374990|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1374991|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1374992|NCT01510327|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1374993|NCT01510327|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1374994|NCT01510327|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1374995|NCT01510327|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1374996|NCT01510327|Secondary|All Death|Number of participants no longer alive|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants who died|||Number
1375022|NCT01509638|Secondary|Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants who answered yes|||Number
1374997|NCT01510327|Secondary|Total Blood Clearance - Everolimus (CL)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; CL could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine CL value.|||L/h||Standard Deviation|Mean
1374998|NCT01510327|Secondary|Terminal Phase Half-life (t1/2) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; half-life could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine half-life.|||Hours||Standard Deviation|Mean
1374999|NCT01510327|Secondary|Time of Occurrence of Maximum Everolimus Concentration (Tmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups reported here had 3 or more subjects.|||hours||Standard Deviation|Mean
1375000|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; AUC0-∞ could be inaccurately determined for a subset of samples. AUC0-∞ determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine AUC0-∞.|||ng*hr/mL||Standard Deviation|Mean
1375001|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.|||ng*hr/mL||Standard Deviation|Mean
1375002|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.|||ng*hr/mL||Standard Deviation|Mean
1375003|NCT01510327|Primary|Maximum Observed Everolimus Blood Concentration (Cmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.|||ng/mL||Standard Deviation|Mean
1375004|NCT01510158|Secondary|Tophus|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 Months||||Proportion of Subjects|||Number
1375005|NCT01510158|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12|12 Months||||Gout Flares||Standard Deviation|Mean
1375006|NCT01510158|Primary|Proportion of Subjects With an sUA Level That is < 6.0 mg/dL||6 Months, analysis after all subjects complete 12 months|Intent-to-Treat Population|||Proportion of Subjects|||Number
1375007|NCT01510145|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|This anaylysis population includes all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.|||percentage of patients|||Number
1375008|NCT01510145|Primary|Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|This analysis population includes all patients who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
1375009|NCT01509807|Secondary|Experienced Any Health Problems or Changed in Health Since Hospital Discharge|Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
1375023|NCT01509638|Secondary|Patient Made Unplanned Visit(s) With Any Healthcare Providers|Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants who answered yes|||Number
1375010|NCT01509807|Secondary|Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
1375011|NCT01509807|Secondary|Make Unplanned VIsit(s) With Any Healthcare Providers|Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
1375012|NCT01509807|Secondary|Readmission to Hospital Since Discharge|Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
1375013|NCT01509807|Secondary|Patient Discharged From the Hospital for at Least 3 Days|Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
1375014|NCT01509807|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||percentage of patients|||Number
1375015|NCT01509807|Primary|Health Economic Benefit - Length of Stay|Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||days||Full Range|Median
1375016|NCT01509807|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||events|||Number
1375017|NCT01509807|Primary|Health Economic Benefits - Total Cost of Hospitalization|1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||dollars||Standard Deviation|Mean
1375018|NCT01509807|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time the discharge order is written or Day 30, whichever is sooner|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||mg morphine equivalent||Standard Deviation|Mean
1375019|NCT01509664|Primary|Gross Weekly Purchasing of Fruits and Vegetables|Gross weekly purchasing of fruits and vegetables from the discounted items list in $|week||||$||Standard Error|Mean
1375020|NCT01509638|Secondary|Time to First Opioid Administration|Time in hours to first opioid administration|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||hours||Full Range|Median
1375021|NCT01509638|Secondary|Experienced Health Problems or Changes in Health Since Hospital Discharge|Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants who answered yes|||Number
1375024|NCT01509638|Secondary|Patient Discharged From Hospital for at Least 3 Days|Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants|||Number
1375025|NCT01509638|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical analgesia|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants|||Number
1375026|NCT01509638|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||number of events||Standard Deviation|Mean
1375027|NCT01509638|Primary|Health Economic Benefit|Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||days||Full Range|Median
1375028|NCT01509638|Primary|Health Economic Benefits|Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||dollars||Standard Deviation|Mean
1375029|NCT01509638|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||mg morphine equivalent||Standard Deviation|Mean
1375030|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding tumor ki67 expresion in 121 patients.|||month||95% Confidence Interval|Median
1375031|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2|"To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding HER2 status in 31 patients.|||month||95% Confidence Interval|Median
1375032|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were 5 patients that have not received previous tamoxifen or an aromatases inhibitor, so they are not included in one of these two groups.|||month||95% Confidence Interval|Median
1375033|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases|"Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients.|||month||95% Confidence Interval|Median
1375034|NCT01509625|Secondary|Number of Participants With Adverse Events||22 months||||percentage of patients||95% Confidence Interval|Number
1375035|NCT01509625|Secondary|Duration of Clinical Benefit|"Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|For the study of the duration of the clinical benefit, only the patients that get a clinical benefit could be analyzed (this is the reason becasuse the number of participants analyzed was 140)|||month||95% Confidence Interval|Median
1375036|NCT01509625|Secondary|Overall Survival|Response to treatment with fulvestrant in terms of Overall Survival|22 months||||month||95% Confidence Interval|Median
1375037|NCT01509625|Secondary|Clinical Benefit Rate|Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).|22 months||||percentage of patients|||Number
1375038|NCT01509625|Primary|Progression Free Survival|"Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|22 months||||month||95% Confidence Interval|Median
1375039|NCT01509586|Primary|Quit Attempts and Abstinence|"% of study participants making a quit attempt or staying abstinent from smoking during the study~Notes:~Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence"|From study enrollment through end of one-year follow up||||percentage of participants|||Number
1375040|NCT01509183|Secondary|Change in the Proportion of SABA-free Days From Baseline to 12 Months|Evaluate the change in the proportion of SABA-free days from baseline to 12 months|Baseline to 12 months||||% Change in proportion of SABA-free days|||Number
1375041|NCT01509183|Primary|Change in Mean SABA Use|Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).|Change in mean SABA use over the course of 12 months||||mean puffs per day||Standard Deviation|Mean
1375042|NCT01509105|Secondary|Number of Participants Discontinued Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose of study vaccination (13 Months)|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.|||participants|||Number
1375043|NCT01509105|Secondary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no-resolved'.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."|||participants|||Number
1375044|NCT01509105|Secondary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, n signifies those participants who were evaluable at specified time points."|||participants|||Number
1375045|NCT01509105|Secondary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."|||days||Standard Deviation|Mean
1375046|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375057|NCT01509079|Secondary|Serum Estradiol Concentrations||baseline and 6 months|only participants whose serum was obtained at both time points are included|||pg/ml||Standard Error|Geometric Mean
1375058|NCT01509079|Secondary|Average Percent Adherence to Vitamin D Interventio|adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months|average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months||||% of adherence for each treatment arm|||Number
1375047|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375048|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375049|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375050|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375051|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375052|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375053|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “number of participants analyzed” (N) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1375054|NCT01509079|Secondary|Vitamin D Binding Protein Genotype||Baseline|||||||
1375055|NCT01509079|Secondary|Bone Mineral Density||Change from screen to 6 months|||||||
1375056|NCT01509079|Secondary|Change in Steady State Concentrations of Serum Anastrazole and Letrozole|Difference in steady state concentrations in plasma from baseline to 6 months|baseline to 6 months|Only study participants with baseline and 6 month blood samples available were analyzed|||mg/L||Standard Deviation|Mean
1375059|NCT01509079|Secondary|Change in PROMIS Physical Functioning Questionnaire|PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).|baseline to 6 months|only data from participants with measures at both time points are included|||units on a scale||Standard Deviation|Mean
1375060|NCT01509079|Primary|Change in Hand Grip Strength||baseline to 6 months|only data from participants that were collected at both time points is included|||pounds||Standard Deviation|Mean
1375061|NCT01509079|Primary|Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale|The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia|baseline to 6 months|Only participants who provided data at both time points are included|||units on a scale||Standard Deviation|Mean
1375062|NCT01509053|Secondary|Clinical Global Impression of Improvement (CGI-I) Score|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
1375063|NCT01509053|Secondary|Clinical Global Impression of Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
1375064|NCT01509053|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores|The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
1375065|NCT01509053|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
1375066|NCT01509053|Primary|Comparison of Inpatient Psychiatric Hospitalization Rates|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.|Retrospective period Months 4-6; Prospective period Months 4-6|Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated.||||||
1375067|NCT01509040|Secondary|Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses|Clinical diagnoses of cerebral bleeding, stroke, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, rib or sternal fractures, internal thoracic or abdominal injuries as noted in the discharge summary|Discharge||||participants|||Number
1375068|NCT01509040|Secondary|Unexpected Adverse Device Events (UADE)|These will be defined as any unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in this investigation plan or application which will be submitted to the Food and Drug Administration (including a supplementary plan or application), or any other unexpected serious problem associated with a device. The death or neurological impairment of an individual patient will not be considered an adverse event in this study.|48 hours||||participants|||Number
1375069|NCT01509040|Secondary|Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia|"ST-Elevation Myocardial Infarction- ECG criteria and biomarker criteria for acute infarction.~Radiographic Pulmonary Edema- radiographic presence of alveolar or interstitial edema, bilateral pleural effusions, cardiomegaly or venous congestion.~Arrhythmia- other than sinus rhythm observed after randomization. Arrhythmia requiring treatment- rhythm with subsequent use of an antiarrhythmic drug or electrical therapy observed after randomization.~Arrhythmia with cardiovascular instability- any rhythm with cardiovascular instability as determined by the DSMB, observed after randomization."|48 hours||||Participant|||Number
1375070|NCT01509040|Secondary|Expected Adverse Event|"Device-Related Hematoma at insertion site, vessel perforation, wound infection, deep venous thrombosis or pulmonary embolism.~Device Failure Mechanical failure Hypertension- SBP>160 mmHg, or DBP >120 mmHg. Hypotension- SBP<60 mmHg. Hypervolemia- CVP > 12 cm. Hypovolemia- CVP < 2 cm. Hypokalemia- serum potassium concentration < 3.5 mmol/L. Alkalosis- serum bicarbonate > 32 mmol/L. Hyperglycemia- serum glucose > 240 mg/dL. Hypophosphatemia- serum phosphate concentration < 0.8 mmol/L. Hypocalcemia- serum ionized calcium < 2.2 mmol/L. Lactic acidosis- serum lactate > 6 mmol/L."|48 hours||||participants|||Number
1375071|NCT01509040|Secondary|Time Interval From 911 Call to Patient Death|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|1 year||||Days||Inter-Quartile Range|Mean
1375072|NCT01509040|Secondary|Number of Hospital Days|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|6 months||||days||Inter-Quartile Range|Mean
1375080|NCT01508936|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion at screening, weeks 8 and 16 or early withdrawal. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).~Endpoint =week 16 or early withdrawal.~Counts represent the total number of participants at each time point with a positive immunogenicity test, and not 'new' participants with a positive test. An overall status of positive includes participants who had a positive ADA at any time point."|Screening (Week -3), Weeks 8 and 16|Safety analysis set; antibody assessments reported for active treatment arm only.|||participants|||Number
1375081|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities|Counts represent the number of participants with potentially clinically significant ECG abnormalities as assessed by the investigator.|Week 16 or endpoint|Safety analysis set|||participants|||Number
1375082|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values during any of the treatment period exams.~Significance criteria~Heart rate - high: >100 and increase of >= 30 beats/minute (bpm)~Sitting systolic blood pressure - high: >160 and increase of >=30 mmHg~Sitting systolic blood pressure - low: <90 and decrease of >=30 mmHg~Sitting diastolic blood pressure - high: >100 and increase of >=12 mmHg~Sitting diastolic blood pressure - low: <50 and decrease of >=12 mmHg~Body temperature - high: >100.5° Fahrenheit or 38.1° Celsius and increase of >2°~Body temperature - low: <96.5° Fahrenheit or <35.8° Celsius"|Week 4 to Week 28|Safety analysis set of participants with assessments|||participants|||Number
1375083|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values during any of the lab tests conducted during the treatment period.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 4-49 U/L.~Total bilirubin: >=34.2 μmol/L~Creatinine phosphokinase: >5*ULN. Normal range is 24-207 U/L.~White blood cells: <=3.0 or >20 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Platelets: <=75 10^9/L~Absolute neutrophil count: <=1.0 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 16|Safety analysis set with assessments|||participants|||Number
1375084|NCT01508936|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 28|The safety analysis set includes all patients who took at least 1 dose of study drug, regardless of whether the patients were randomized.|||participants|||Number
1375085|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16|The ACQ score was measured using the ACQ-7. Six questions are self-assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12 and 16|Full analysis set. Number of participants analyzed represents # with ACQ baseline values. Number participants with assessments in the timeframes are listed with the time designation. ACQ were excluded if obtained at visits which were preceded by usage within 7 days of a limited subset of medications that could significantly alter interpretation.|||units on a scale||Standard Error|Least Squares Mean
1375086|NCT01508936|Secondary|Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint|Blood eosinophil counts were measured using a standard complete blood count with differential blood test at each scheduled visit. Follow-up was performed approximately 12 weeks after the 16 week treatment period. Endpoint is the last post-baseline assessment.|Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)|Full analysis set. Number of participants analyzed represents # with blood eosinophil count baseline values. Number participants with assessments in the timeframes are listed with the time designation.|||10^9/liter||Standard Deviation|Mean
1375087|NCT01508936|Secondary|Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16|SABA are used for quick relief of asthma symptoms. The number of times SABA therapy was used was assessed using 3 day recall at scheduled visits. Participants were asked to recall whether SABAs were used within 3 days of the scheduled visit and, if so, how many puffs were used. Daily use was the average of those 3 days. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with SABA use baseline values. Number participants with assessments in the timeframes are listed with the time designation.|||puffs of SABA/day||Standard Error|Least Squares Mean
1375088|NCT01508936|Secondary|Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16|The FEF25%-75% is the forced expiratory flow at 25% to 75% of the forced vital capacity. FEF25%-75% was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEF25%-75% baseline values. Number of participants with assessments in the timeframes are listed with the time designation.|||liters/second||Standard Error|Least Squares Mean
1375089|NCT01508936|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. FV was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FVC baseline values (one reslizumab participant was missing a valid baseline FVC.) Number participants with assessments in the timeframes are listed with the time designation.|||liters||Standard Error|Least Squares Mean
1375090|NCT01508936|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient’s predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.|||percentage of predicted FEV1||Standard Deviation|Mean
1375091|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16|FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.|||liters||Standard Error|Least Squares Mean
1375092|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.~As with the primary outcome, data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group. However the FEV1 subpopulation includes participants with more impaired lung function (% predicted FEV1 <85% at baseline)."|Baseline (Day 1), Week 16|The FEV1 sub-population analysis set includes all participants in the FAS with % predicted FEV1 <85% at baseline. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.|||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
1375093|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient’s % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.~During study (Weeks 4, 8, 12 and 16) average value was calculated from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, history of asthma exacerbation in the previous year, height, baseline value, and sex as fixed factors, and patient as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set of participants who contributed at least once to the analysis. ACQ were excluded from the FAS if they were obtained at scheduled visits which were preceded by usage within 7 days of a limited subset of medications that could significantly confound interpretation.|||units on a scale||Standard Error|Least Squares Mean
1375094|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.~During study (Weeks 4, 8, 12 and 16) average value was calculated using a mixed effects model for repeated measures (MMRM) with treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and contributed at least once to the analysis. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.|||liters||Standard Error|Least Squares Mean
1375095|NCT01508936|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.~Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group."|Baseline (Day 1), Week 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and had assessments in the timeframes. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.|||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
1375096|NCT01508910|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period||From randomization until the end of the 24 month follow-up period|Safety Population as Treated.|||percent|||Number
1375462|NCT01505374|Primary|Visual Analogue Scale Pain Score|The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively. VAS pain scores could range from 0 to 10. Higher values represent a worse outcome.|Up to postoperative day 1||||units on a scale||Standard Deviation|Mean
1375097|NCT01508910|Secondary|Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period|"Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee.~The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke."|From randomization until the end of the 24 month follow-up period|Participants in the safety population as Treated.|||percent||95% Confidence Interval|Number
1375098|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit||6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||angina episodes per week||Standard Deviation|Mean
1375099|NCT01508910|Secondary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||seconds||Standard Deviation|Mean
1375100|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit|Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||angina episodes per week||Standard Deviation|Mean
1375101|NCT01508910|Primary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||seconds||Standard Deviation|Mean
1375102|NCT01508832|Primary|The Change in the Average Finger Temperature From Baseline to Post-intervention.||30 minutes prior and 240 minutes post intervention.|The correspondingly-treated(lidocaine, bupivacaine) finger of all 12 study participants included in analysis for each arm/group|||degrees centigrade||Standard Error|Mean
1375103|NCT01508702|Primary|Number of Subjects With an sUA Level That is < 6.0 mg/dL||6 months|ITT Population|||Number of Subjects|Participants||Number
1375104|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment|"Subjects rated their constant pain and hypersensitivity using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks||||Visual Analog Scale||Standard Deviation|Mean
1375105|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Burning After Treatment|"Subjects rated their burning pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks|Only subjects|||Visual Analog Scale||Standard Deviation|Mean
1375106|NCT01508676|Primary|VAS After Treatment|"Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks.|Only subjects who completed both phases of the crossover study were considered for data analysis.|||Visual Analog Scale||Standard Deviation|Mean
1375107|NCT01508455|Secondary|Time to Successful Extubation||From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours)|Subjects who had successful extubation alone (n=5) were included in this analysis.|||Hours||95% Confidence Interval|Median
1375108|NCT01508455|Secondary|Time Spent With a Total N-PASS Score >3 During DEX Infusion|The N-PASS score >3 indicates adequately sedated and not manifesting signs of pain/agitation.|Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.|||Hours||Standard Deviation|Mean
1375109|NCT01508455|Secondary|Amount of Rescue Medication for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|Number of subject who received rescue medication for analgesia during DEX infusion|||mcg/kg|||Number
1375110|NCT01508455|Secondary|Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|No participants analyzed for this assessment since none required rescue Midazolam for sedation.||||||
1375111|NCT01508455|Secondary|Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.|||participant|||Number
1375112|NCT01508455|Primary|Percent of Subjects Requiring Rescue Midazolam for Sedation||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All Subjects who received study drug for at least 6 hours|||percentage of participants|||Number
1375113|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 24 hours heart rate at Week 12 and of the baseline heart rate was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
1375114|NCT01508325|Secondary|Heart Rate Response Rate|Heart rate response was defined as decrease in heart rate from baseline >=10 percent (%). Heart rate response rate was calculated by using the number of subjects with heart rate response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.|||percentage of subjects|||Number
1375115|NCT01508325|Secondary|Blood Pressure Response Rate|Blood pressure response was defined as DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.|||percentage of subjects|||Number
1375116|NCT01508325|Secondary|Change From Baseline in 24-hour Blood Pressure Variability at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
1375117|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
1375118|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
1375119|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12|The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
1375120|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
1375121|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
1375122|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
1377955|NCT01475513|Secondary|Change From Baseline in Glucose Effectiveness|Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition|Baseline, 6 months||||1000 * min ^ -1||95% Confidence Interval|Mean
1375123|NCT01508325|Primary|Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
1375124|NCT01508325|Primary|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment|Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all the randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively|||mmHg||Standard Deviation|Mean
1375125|NCT01508169|Secondary|Manchester Foot and Pain Disability Index(MFPDI)|"The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase Because of pain in my feet…, organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: none of the time (score = 0), some days (score = 1), and most days/every day (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability."|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||scores on a scale||Standard Deviation|Mean
1375126|NCT01508169|Secondary|Numeric Pain Scale|Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||units on a scale||Standard Deviation|Mean
1375127|NCT01508169|Primary|Timed up and Go Test (TUG)|The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||seconds||Standard Deviation|Mean
1375128|NCT01508169|Primary|Berg Balance Scale (BBS)|The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||scores on a scale||Standard Deviation|Mean
1375129|NCT01508130|Secondary|Change From Baseline in Work Loss And Productivity Outcomes (WPAI)|WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.|Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||units on a scale||Standard Error|Least Squares Mean
1375130|NCT01508130|Secondary|Number of Participants With Any AEs and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. All 671 participants received at least one dose of study drug; however, 632 of these participants were included in the safety population.|||participants|||Number
1375131|NCT01508130|Secondary|Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.|||participants|||Number
1378232|NCT01474200|Secondary|EFFICACY: Total Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics|Index Hospitalization, an average of 8 days||||mL||Standard Deviation|Mean
1375132|NCT01508130|Secondary|Number of Participants With Safety-related Dose Reductions|The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.|||participants|||Number
1375133|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label|As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.|Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)|The safety population was defined as all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375134|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label|As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.|Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375135|NCT01508130|Secondary|Compliance of Study Treatment|Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.|Weeks 4, 8, 12, and 24|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375136|NCT01508130|Secondary|Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||Percentage of dose reduction||Standard Deviation|Mean
1375137|NCT01508130|Secondary|Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||Micrograms||Standard Deviation|Mean
1375138|NCT01508130|Secondary|Treatment Duration, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||Weeks||Standard Error|Mean
1375139|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Intolerance|The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||Weeks||Full Range|Median
1375140|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Lack of Efficacy|The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||Weeks||Full Range|Median
1375141|NCT01508130|Secondary|Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment|The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant’s first date of undetectable HCV RNA and the date of the participant’s last dose.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||weeks||Full Range|Median
1375142|NCT01508130|Secondary|Number of Participants With SVR by Subgroups (Demographic and Baseline Factors)|Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease < 2 log10 at Week 12), partial responder (HCV RNA decrease > 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant’s choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.|Week 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375143|NCT01508130|Secondary|Predictors of Sustained Virologic Response by Week|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA < 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA < 50 IU/mL or unquantifiable or HCV-RNA >=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.|Weeks 2, 4, 6, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375144|NCT01508130|Secondary|Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder|The extended VR is defined as initial HCV RNA < 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA < 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by >=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA < 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375145|NCT01508130|Secondary|Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above|VRVR was defined as HCV RNA < 50 IU/mL at treatment Week 2; RVR as HCV RNA < 50 IU/mL by treatment Week 4, but no HCV RNA < 50 IU/mL at Week 2; Week 8 VR as HCV RNA < 50 IU/mL by study Week 8 but no HCV RNA < 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA < 50 IU/mL by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 12.|Weeks 2, 4, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375146|NCT01508130|Secondary|Number of Participants With Virologic Response (VR)|VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)|Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
1375147|NCT01508130|Primary|Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period|12 weeks or later post-completion of the treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||participants|||Number
1375148|NCT01508130|Primary|Time to Premature Treatment Discontinuation Due to Any Reason|Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason – first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.|Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)|modified all-treated (mTRT) population: It included all enrolled participants who had an hepatitis C Virus Ribo Nucleic Acid (HCV RNA) of 50 IU/mL or more just prior to start chronic hepatitis C (CHC) therapy, received 1 triple therapy (PegIFN, RBV, and TEL or BOC), and treatment documentation was sufficient for assignment to treatment groups.|||weeks||95% Confidence Interval|Median
1375149|NCT01508117|Primary|Overall Survival||average 1 year||||years|||Number
1375150|NCT01508052|Primary|Core Body Temperature|Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.|from baseline record core temperature every 15 minutes up to operative end||||degree C||Standard Deviation|Mean
1375152|NCT01508013|Primary|Indoor Tanning Intentions|A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the next year.|||units on a scale||Standard Deviation|Mean
1375153|NCT01508013|Primary|Indoor Tanning Behavior|Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the future.|||Indoor tanning sessions over past year||Standard Deviation|Mean
1375154|NCT01507896|Primary|Incremental Recovery (IR) at 15±5 Minutes Following Loading Dose Prior to Surgery|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 15±5 minutes for the loading dose.|Within 60 minutes prior to surgery and 15 ± 5 minutes after loading dose/rebolus, if applicable.|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who provided data for incremental recovery (IR) after the loading dose prior to surgery.~Note: a unique participant could have more than one surgical procedure."|||[IU/dL] : [IU/kg]|surgeries with IR data|Standard Deviation|Mean
1375155|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Vss was computed as CL·MRT.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||dL/kg|pre-surgical PK assessments|Standard Deviation|Mean
1375156|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|T1/2 was determined as ln2 / λz.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
1375157|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Incremental Recovery (IR) at 30 Min|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 30±5 minutes for pre-surgical PK.|Within 30 mins pre-infusion and post-infusion at 30 minutes|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||IU/dL : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
1375158|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|CL is the volume of plasma which is completely cleared of study product per unit time and is calculated as the dose divided by the total area under the curve from 0 to infinity (AUC0-inf).|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||dL/(kg•hr)|pre-surgical PK assessments|Standard Deviation|Mean
1375159|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Mean Residence Time (MRT)|The MRT is the average time that the study product stays in the body (or plasma) and is calculated as: AUMC 0-inf / AUC 0-inf, where AUMC 0-inf was determined in a similar manner as AUC 0-inf.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
1375160|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve Per Dose (Total AUC/Dose)|Total AUC/Dose is also AUC0-inf (area under the plasma concentration/time curve from time 0 to infinity) and was defined as AUC0-t + Ct / λz, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration and λz is the terminal rate constant.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
1375161|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 72 Hours Post-infusion Per Dose|AUC0-72h (area under the plasma concentration/time curve from time 0 to 72 hours) was computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R2.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
1375162|NCT01507896|Primary|Safety: Occurence of a Thrombotic Event||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||surgeries|treatments with BAX326 before surgery||Number
1375164|NCT01507896|Primary|Safety: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|If there was more than 2-dilution increase as compared to pre-study level at screening.|Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||participants|treatments with BAX326 before surgery||Number
1375165|NCT01507896|Primary|Safety: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||participants|treatments with BAX326 before surgery||Number
1375166|NCT01507896|Primary|Volume of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.~Note: a unique participant could have more than one surgical procedure."|||mL|surgery where blood transfusion given|Standard Deviation|Mean
1375167|NCT01507896|Primary|Number of Units of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.~Note: a unique participant could have more than one surgical procedure."|||units|surgery where blood transfusion given|Standard Deviation|Mean
1375168|NCT01507896|Primary|Total Weight-Adjusted Dose of BAX326 Per Participant|Assessed for the intra- and postoperative periods.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||IU/kg|surgeries|Standard Deviation|Mean
1375169|NCT01507896|Primary|Daily Weight-Adjusted Dose of BAX326 Per Participant|"Daily weight-adjusted doses of BAX326 per participant were recorded from the day of surgery until postoperative Days 11+.~Each category in outcome measure includes number of all, major and minor surgeries, respectively, if different from the totals."|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||IU/kg|surgeries|Standard Deviation|Mean
1375170|NCT01507896|Primary|Actual Postoperative Blood Loss Compared to Average and Maximum Blood Loss Predicated Preoperatively by the Operating Surgeon|"Predicted average/maximum blood loss minus actual blood loss for participants who had a drain placed during surgery.~Prior to the surgery, the surgeon will predict the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study subject for the postoperative period until drain removal."|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries with drain placed|Standard Deviation|Mean
1375171|NCT01507896|Primary|Actual Postoperative Blood Loss|Postoperative blood loss was based on the drainage fluid and was only assessed for participants who had a drain placed during surgery.|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries with drain placed|Standard Deviation|Mean
1375172|NCT01507896|Primary|Postoperative Hemostatic Efficacy on Day of Discharge|"Assessment by the operating surgeon on a 4 point ordinal scale:~Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant~Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant~Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||surgeries|surgeries||Number
1375173|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Postoperative Day 3|"Assessment by the operating surgeon on a 4 point ordinal scale:~Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant~Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant~Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set who were provided with a hemostatic efficacy assessment by the operating surgeon at post operative day 3 where no drain was employed.~Note: a unique participant could have more than one surgical procedure."|||surgeries|surgeries||Number
1375174|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Drain Removal|"The postoperative hemostatic efficacy was to be assessed by the operating surgeon according to the following criteria (4-point ordinal scale):~Excellent: Volume in drain was less than or equal than that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )~Good: Volume in drain was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101% - 150%)~Fair: Volume in drain was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)~None: Uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure"|||major surgeries with drain placed|major surgeries with drain placed||Number
1375175|NCT01507896|Primary|Actual Intraoperative Blood Loss Compared to Average and Maximum Blood Loss Predicted Preoperatively by the Operating Surgeon|Predicted average/maximum blood loss minus actual blood loss. Prior to the surgery, the surgeon predicted the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study participant for the intraoperative period.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries|Standard Deviation|Mean
1375176|NCT01507896|Primary|Actual Intraoperative Blood Loss|Actual intraoperative blood loss was determined by the drainage volume, if a drain was placed, and the estimated blood loss into swabs and towels during the procedure.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries|Standard Deviation|Mean
1375177|NCT01507896|Primary|Intraoperative Hemostatic Efficacy|"Assessment by the operating surgeon on a 4 point ordinal scale (according to the definitions provided below):~Excellent: Intraoperative blood loss was less than or equal to that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )~Good: Intraoperative blood loss was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101 – 150%)~Fair: Intraoperative blood loss was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)~None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 and had surgery.~Note: a unique participant could have more than one surgical procedure."|||surgeries|surgeries||Number
1375178|NCT01507831|Post-Hoc|Percentage of Participants Who Experienced Major Adverse CV Events|Major adverse CV events were defined as all adverse CV events except Congestive heart failure (CHF) requiring hospitalization; and ischemia-driven coronary revascularization procedure.|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.|||percentage of participants|||Number
1375179|NCT01507831|Other Pre-specified|Percentage of Participants Who Experienced Cardiovascular (CV) Events|CV events included coronary heart disease (CHD) death; non-fatal myocardial infarction (MI); fatal and non-fatal ischemic stroke; unstable angina requiring hospitalization; congestive heart failure (CHF) requiring hospitalization; ischemia-driven coronary revascularization procedure. Reported events are CV events as confirmed by an independent Clinical Events Committee (CEC) that occurred during the treatment emergent period ( i.e. from first dose up to the last dose of study drug + 70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.|||percentage of participants|||Number
1375180|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.|||percent change||Standard Error|Least Squares Mean
1375181|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.|||percent change||Standard Error|Least Squares Mean
1375182|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1375183|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1375184|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A1 ITT population.|||percent change||Standard Error|Least Squares Mean
1375185|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1375186|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1375188|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).|||percent change||Standard Error|Least Squares Mean
1375189|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1375190|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1375191|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
1375192|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.|||percentage of participants|||Number
1375193|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
1375194|NCT01507831|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.|||percentage of participants|||Number
1375195|NCT01507831|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
1375196|NCT01507831|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
1375197|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
1375198|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
1375199|NCT01507831|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
1375200|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
1375201|NCT01507831|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
1375781|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
1375202|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
1375203|NCT01507831|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
1375204|NCT01507831|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
1375205|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
1375206|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
1375207|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1375208|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
1375209|NCT01507831|Primary|Percentage of Participants Who Experienced Adverse Events (AEs)|Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).|||percentage of participants|||Number
1375210|NCT01507662|Primary|Guideline Concordant Osteoporosis Therapy|Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine ≤−2.5 or FRAX ≥20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between −1.0 and −2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture ≥20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between −1 and −2.5) and FRAX <20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis.|12 weeks after DXA||||Participants|||Count of Participants
1375211|NCT01507493|Secondary|Preoperative Pressure Pain Tolerance (PTO)|The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say “ok” when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.|12 hours before the operation||||kg/cm2||Standard Deviation|Mean
1375212|NCT01507493|Primary|PCA Press Frequency 48h After Operation.||48 hours after the operation||||presses per day||Standard Deviation|Mean
1375213|NCT01507493|Secondary|Preoperative Pressure Pain Threshold (PPT)|The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say “pain” when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.|12 hours before the operation||||kg/cm2||Standard Deviation|Mean
1375214|NCT01507493|Secondary|The Visual Analog Scale 48h After Operation.|The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain|48 hours after the operation||||units on a scale||Standard Deviation|Mean
1375215|NCT01507493|Primary|Opioid Consumption Dose 48h After Operation.||48 hours after the operation||||microgramme||Standard Deviation|Mean
1375216|NCT01507246|Primary|Health Economic Benefits - Length of Stay|Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Up to Day 30|All subjects analyzed, no censored events|||days||Inter-Quartile Range|Median
1385426|NCT01402128|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||µEq/L||Standard Deviation|Mean
1375220|NCT01507233|Secondary|Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia.|"Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.~Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
1375221|NCT01507233|Primary|Health Economic Benefits|"Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.~Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to Day 30|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
1375222|NCT01507233|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
1375223|NCT01507220|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
1375224|NCT01507220|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||Adverse events|||Number
1375225|NCT01507220|Primary|Health Economic Benefit|"Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner.~Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
1375226|NCT01507220|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
1375227|NCT01507181|Secondary|Patient Rated Inventory of Side Effects (PRISE)|The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Data reported in in Adverse Events section.|duration of study||||events|||Number
1375228|NCT01507181|Secondary|The Clinician-Administered Dissociative States Scale (CADSS)|The CADSS measures dissociation with higher scores indicating more severe symptoms (scale range 0 – 92).|baseline, 40 minutes post infusion and 240 minutes post infusion||||units on a scale||Standard Deviation|Mean
1375229|NCT01507181|Secondary|The Brief Psychiatric Rating Scale (BPRS)|The BPRS measures psychomimetic effects with higher scores indicating more severe symptoms (scale range 7 – 49).|baseline, 40 minutes post infusion, and 240 minutes post infusion||||units on a scale||Standard Deviation|Mean
1375230|NCT01507181|Secondary|The Young Mania Rating Scale (YMRS)|An 11-item questionnaire, used to assess manic symptoms based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.|baseline, 40 minutes post infusion, 240 minutes post infusion||||units on a scale||Standard Deviation|Mean
1375231|NCT01507181|Secondary|Suicidality Item of the MADRS (MADRS-SI)|The MADRS-SI ranges from 0 to 6; a score of 2 corresponds to fleeting, passive SI; a score of 4 indicates that SI is frequent with at least moderate intensity but without specific plans or intention; a score of 6 corresponds to active intention and planning for suicide.|24 hours post infusion||||units on a scale||Standard Deviation|Mean
1375232|NCT01507181|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|up to 7 days post infusion||||units on a scale||Standard Deviation|Mean
1375233|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 48 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 48 hours post infusion||||units on a scale||Standard Deviation|Mean
1375234|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 24 hours post infusion||||units on a scale||Standard Deviation|Mean
1375247|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.|||unitless||95% Confidence Interval|Number
1375235|NCT01507155|Secondary|Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months|"To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales:~Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression~Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life~Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating~the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe"|3 months|Only 197 patients completed self-assessments at 3 months.|||Scores on a scale||Standard Deviation|Mean
1375236|NCT01507155|Primary|Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months|To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).|3 months||||Participants|||Number
1375237|NCT01507103|Primary|Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline|IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available||||||
1375238|NCT01507103|Secondary|Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)|Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.|Baseline and Week 18 (follow-up / end-of trial)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analysed for each category.|||log2 (percentage of T cells)||Standard Deviation|Mean
1375239|NCT01507103|Secondary|Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)|Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).|Baseline and Week 14 (post-surgery)|The pre-specified statistical threshold for reporting of results of planned analysis for either arm or interaction effect was not met in the analysis population. Hence the data was not assessed for the outcome measure.||||||
1375240|NCT01507103|Primary|Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline|IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available||||||
1375241|NCT01507103|Primary|Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category|A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).|18 weeks|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive.|||subjects|||Number
1375242|NCT01507103|Primary|Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)|Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.|Baseline and Week 14 (post-surgery)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analyzed for each category.|||TILs per 100 tumor cells||Standard Deviation|Mean
1375243|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||root mean square error (kg)|||Number
1375244|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||correlation coefficieint|||Number
1375245|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Percentage Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||percentage error||Standard Deviation|Mean
1375246|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.|study day 1|Final population for data analysis.|||percent of estimations||95% Confidence Interval|Number
1385427|NCT01402128|Secondary|Changes in Triglyceride|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
1375248|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.|||unitless||95% Confidence Interval|Number
1375249|NCT01507090|Primary|Predictive Performance of the Mercy TAPE|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||root mean square error (kg)|||Number
1375250|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||correlation coefficient|||Number
1375251|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||kilograms||Standard Deviation|Mean
1375252|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Percent of Participants)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg). The outcome measure below relfects the percent of participants with weight estimated within within 20% of actual weight.|study day 1||||percent of participants||95% Confidence Interval|Number
1375253|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Slope)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1||||unitless||95% Confidence Interval|Number
1375254|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Intercept)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1||||kilograms||95% Confidence Interval|Number
1375255|NCT01507090|Secondary|Device Print Batch Variability|"Geometric mean of the ratio (CV) of true to estimated weight calculated by TAPE version. Mercy TAPEs were printed in 2 batches numbers 1 and 2 accordingly."|study day 1||||ratio||Geometric Coefficient of Variation|Geometric Mean
1375256|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Percentage Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||percentage error||Standard Deviation|Mean
1375257|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||kilograms||Standard Deviation|Mean
1375258|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Intercept)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.|||kilograms||95% Confidence Interval|Number
1375259|NCT01507090|Secondary|Inter-rater Reliability for the 2D and 3D Mercy TAPEs.|Intraclass correlation coefficient|study day 1|All pre-qualified study coordinators|||Intraclass correlation coefficient|||Number
1375260|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Slope)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.|||unitless||95% Confidence Interval|Number
1375261|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.|study day 1|Final population for data analysis.|||percentage of participants||95% Confidence Interval|Number
1375262|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||1/Liter||Geometric Coefficient of Variation|Geometric Mean
1375263|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
1375264|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||1/Liter||Geometric Coefficient of Variation|Geometric Mean
1375265|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
1375266|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of Rivaroxaban After Last Dose|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|3, 24, 48, and 72 h after the last administration of rivaroxaban|PK/PD set; derived parameter could not be evaluated for all participants.|||hours||Geometric Coefficient of Variation|Geometric Mean
1375267|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Minimum (Trough) Concentration (Ctrough) of Rivaroxaban After Second to Fourth Dose|Ctrough refers to the time after dosing when the drug concentration is expected to reach its minimum (trough) concentration.|Always 24 h after the second, third, and fourth dose|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
1385428|NCT01402128|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
1375268|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Maximum (Peak) Concentration (Cpeak) of Rivaroxaban After Second to Fourth Dose|Cpeak refers to the time after dosing when the drug concentration is expected to reach its maximum (peak) concentration.|Always 3 h after second, third, and fourth dose|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
1375269|NCT01507051|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Rivaroxaban After First Dose|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||hours||Full Range|Median
1375270|NCT01507051|Secondary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||Kg/L||Geometric Coefficient of Variation|Geometric Mean
1375271|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Divided by Dose Per kg Body Weight [AUC(0-24)Norm] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC(0-24)norm] is defined as AUC divided by dose per kg body weight from zero to 24 hours after first (single) dose.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||Kg*h/L||Geometric Coefficient of Variation|Geometric Mean
1375272|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of S-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set|||hours||Geometric Coefficient of Variation|Geometric Mean
1375273|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of R-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set|||hours||Geometric Coefficient of Variation|Geometric Mean
1375274|NCT01507051|Secondary|Maximum Drug Concentration in Plasma (Cmax) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||microg/L||Geometric Coefficient of Variation|Geometric Mean
1375275|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample ([AUC(0-24)] is defined as area under the concentration vs. time curve from zero to 24 hours after first (single) dose).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||microg*h/L||Geometric Coefficient of Variation|Geometric Mean
1375276|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor IIa activity was the area under the measurement (Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at baseline divided by Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375277|NCT01507051|Secondary|Emax (Maximum Effect) on Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. Emax on Factor IIa activity was measured as the ratio of Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma) at baseline divided by minimum Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375278|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor VIIa activity was the area under the measurement (Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at baseline divided by Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375279|NCT01507051|Secondary|Emax (Maximum Effect) on Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. Emax on Factor VIIa activity was measured as the ratio of Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma) at baseline divided by minimum Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375383|NCT01505881|Primary|Percentage of Patients With Any Adverse Event (AE)|Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
1375280|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak time was the area under the measurement (ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at different time-points divided by ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375281|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak time was measured as the ratio of maximum ETP peak time (measured in minutes as time to reach the maximum coagulation activity) divided by ETP peak time (measured in minutes as time to reach the maximum coagulation activity) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375282|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak was the area under the measurement (ETP peak [measured in nm as maximum coagulation activity] at baseline divided by ETP peak measured [in nm as maximum coagulation activity] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375283|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak was measured as the ratio of ETP peak (measured in nm as maximum coagulation activity) at baseline divided by minimum ETP peak (measured in nm as maximum coagulation activity).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375284|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP lag time was the area under the measurement (ETP lag time [in minutes as measure for the start of coagulation] at different time-points divided by ETP lag time [in minutes as measure for the start of coagulation] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375285|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP lag time was measured as the ratio of maximum ETP lag time (in minutes as measure for the start of coagulation) divided by ETP lag time (in minutes as measure for the start of coagulation) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375286|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP AUC was the area under the measurement (ETP AUC [measured in nm*min as integral of fluorescence measurements] at baseline divided by ETP AUC [measured in nm*min as integral of fluorescence measurements] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375287|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP AUC was measured as the ratio of ETP AUC (measured in nm*min as integral of fluorescence measurements) at baseline divided by minimum ETP AUC (measured in nm*min as integral of fluorescence measurements).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375288|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PiCT was the area under the measurement (PiCT [measured in seconds] at different time-points divided by PiCT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375289|NCT01507051|Secondary|Emax (Maximum Effect) on PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on PiCT was measured as the ratio of maximum PiCT (measured in seconds) divided by PiCT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375290|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of HepTest was the area under the measurement (HepTest [measured in seconds] at different time-points divided by HepTest [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375291|NCT01507051|Secondary|Emax (Maximum Effect) on HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on HepTest was measured as the ratio of maximum HepTest (measured in seconds) divided by HepTest (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375292|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of aPTT was the area under the measurement (aPTT [measured in seconds] at different time-points divided by aPTT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375293|NCT01507051|Secondary|Emax (Maximum Effect) on aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. Emax on aPTT was measured as the ratio of maximum aPTT (measured in seconds) divided by aPTT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375294|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. AUC(0-tn) of anti-Factor Xa activity was the area under the measurement (anti-Factor Xa activity [measured in U/L] at different time-points divided by anti-Factor Xa activity [measured in U/L] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375295|NCT01507051|Secondary|Emax (Maximum Effect) on Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. Emax on anti-Factor Xa activity was measured as the ratio of maximum anti-Factor Xa activity (measured in U/L) divided by anti-Factor Xa activity (measured in U/L) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375296|NCT01507051|Secondary|AUC(0-tn) (Area Under the Inverse Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. AUC(0-tn) of Factor Xa activity was the area under the inverse measurement [100*(Factor Xa activity at baseline (measured as activity per mL) - Factor Xa activity (measured as activity per mL) at different time-points) / Factor Xa activity at baseline (measured as activity per mL)] versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||Percentage of inhibition*h||Geometric Coefficient of Variation|Geometric Mean
1375297|NCT01507051|Secondary|Emax on Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. Emax on Factor Xa activity was calculated as 100*(Factor Xa activity at baseline [measured as activity per mL] - minimum of Factor Xa activity [measured as activity per mL]) / Factor Xa activity at baseline [measured as activity per mL].|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||Percentage of inhibition||Geometric Coefficient of Variation|Geometric Mean
1375298|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) for PT (Measured as INR=International Normalized Ratio)|Prothrombin time – INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT (INR) was the area under the measurement (PT measured as INR at different time-points divided by PT measured as INR at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375299|NCT01507051|Secondary|Emax on PT (Measured as INR=International Normalized Ratio)|Prothrombin time – INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. Emax on PT (INR) was measured as the ratio of maximum INR divided by baseline INR.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375324|NCT01506882|Secondary|Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||days||95% Confidence Interval|Median
1375300|NCT01507051|Secondary|AUCBA(0-tn) (Baseline Adjusted Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUCBA(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points minus PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||s*h||Geometric Coefficient of Variation|Geometric Mean
1375301|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points divided by PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
1375302|NCT01507051|Primary|Emax,BA (Baseline Adjusted Maximum Effect) on Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax,BA on PT was measured as maximum PT (measured in seconds) minus PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||seconds||Geometric Coefficient of Variation|Geometric Mean
1375303|NCT01507051|Primary|Emax (Maximum Effect) on Prothrombin Time (PT) (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax on PT was measured as the ratio of maximum PT (measured in seconds) divided by PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1375304|NCT01506960|Secondary|Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).|Measured at the time of cardiac catheterization|Per protocol|||mm (LCP length)|Participants|Standard Deviation|Mean
1375305|NCT01506960|Primary|Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.|Measured one point in time during cardiac catheterization||||% pts with lipid on NIRS and OCT|||Number
1375306|NCT01506947|Secondary|Number of Participants With Adverse Events|"Serious adverse events were any adverse events meeting any of the following criteria:~An event that resulted in the death of a participant;~An event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken (life-threatening);~Resulted in an admission to the hospital for any length of time or prolonged hospital stay;~An anomaly detected at or after birth, or any anomaly that results in fetal loss;~An event that resulted in a condition that substantially interfered with the activities of daily living;~An important medical event that may not be immediately life-threatening or result in death or hospitalization, but based on medical judgment may have jeopardized the participant and may have required medical or surgical intervention to prevent any of the outcomes listed above.~Adverse events were assessed by the investigator for possible relationship to study drug."|From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.|The safety population included all participants who enrolled.|||participants|||Number
1375307|NCT01506947|Secondary|Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||kRU/L||Standard Deviation|Mean
1375308|NCT01506947|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||mg/mL||Standard Deviation|Mean
1375309|NCT01506947|Secondary|Folic Acid Levels|"Folic acid levels were categorized according to the following laboratory reference ranges:~Low: < 4.6 ng/mL Normal: 4.6 – 18.7 ng/mL High: > 18.7 ng/mL"|Baseline and month 6|Per-protocol analysis set with available data at each time point.|||Participants|||Count of Participants
1375310|NCT01506947|Secondary|Vitamin B12 Levels|"Vitamin B12 levels were categorized according to the following laboratory reference ranges:~Low: < 200 pg/mL Normal: 200 – 950 pg/mL High: > 950 pg/mL"|Baseline and month 6|Per-protocol analysis set with available data at each time point.|||Participants|||Count of Participants
1375311|NCT01506947|Secondary|Mean Alkaline Phosphatase Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||U/L||Standard Deviation|Mean
1375312|NCT01506947|Secondary|Mean Phosphorus Level at Baseline and Month 6||Baseline and Month 6|Participants who completed the study with available data at each time point.|||mg/mL||Standard Deviation|Mean
1375313|NCT01506947|Secondary|Mean Calcium Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||mg/mL||Standard Deviation|Mean
1375314|NCT01506947|Secondary|Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||pg/mL||Standard Deviation|Mean
1375384|NCT01505764|Secondary|Food Diary Calorie Count|change between day 84 and baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
1375315|NCT01506947|Secondary|Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire|The Medical Outcome Study Short Form 36-Item Health Survey (SF-36) is a self-administered questionnaire that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains. The domains include physical (physical functioning, role limitations due to physical health (role-physical), general health perceptions and pain) and mental domains (energy/fatigue (vitality), social functioning, emotional well-being (mental health), and role limitations due to emotional problems (role emotional)). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.|Baseline and Month 6|Per-protocol analysis set|||units on a scale||Standard Deviation|Mean
1375316|NCT01506947|Primary|Mean Erythropoietin Dose Per Visit|The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported.|Baseline and Months 1, 2, 3, 4, 5 and 6|Per-protocol analysis set with EPO dosage available at all visits.|||µg||Standard Deviation|Mean
1375317|NCT01506908|Secondary|Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.|Baseline to Day 5 post treatment administration|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.|||Participants|||Number
1375318|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 10 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique|||Score on a scale||95% Confidence Interval|Least Squares Mean
1375319|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 7 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1375320|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue Baseline, 3 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1375321|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline, 1 minute post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1375322|NCT01506908|Primary|Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline,5 minutes|Intention to Treat (ITT) population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1375323|NCT01506882|Secondary|Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||days||95% Confidence Interval|Median
1375354|NCT01506479|Other Pre-specified|Number of Days of Exercise Per Week|The number of days the participant exercised per week|9 to 26 weeks|Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention.|||Number of days per week||95% Confidence Interval|Mean
1375385|NCT01505764|Secondary|1-repetition Max. Strength|leg extension - percentage of change day 84 to baseline|day 84|only two subjects in each group completed this outcome|||percentage change||Standard Deviation|Mean
1375325|NCT01506882|Secondary|Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||days||95% Confidence Interval|Median
1375326|NCT01506882|Secondary|Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||days||95% Confidence Interval|Median
1375327|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||percentage of participants||95% Confidence Interval|Number
1375328|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||percentage of participants||95% Confidence Interval|Number
1375329|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||percentage of participants||95% Confidence Interval|Number
1375330|NCT01506882|Primary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for the primary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||percentage of participants||95% Confidence Interval|Number
1375331|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by decreasing growth differentiation factor-15 (GDF-15) in UAE subjects. Change in the GDF-15 from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.|||pg/ml||Standard Deviation|Mean
1375332|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces C-reactive protein (CRP) in UAE subjects. Change in the CRP from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.|||ug/ml||Standard Deviation|Mean
1375333|NCT01506726|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by salsalate on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at 6 months). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
1375371|NCT01506193|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout study period (from Day 0 to approximately Month 4)|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
1375334|NCT01506726|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at 6 months). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
1375335|NCT01506726|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at 6 months.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
1375336|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by salsalate on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 6 months. Scores range from 0-188 with higher scores indicating better function.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||scores on a scale||Standard Deviation|Mean
1375337|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by salsalate on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to 6 months. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||t score||Standard Deviation|Mean
1375338|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||change in Z-Score||Standard Deviation|Mean
1375339|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||change in Z-Score||Standard Deviation|Mean
1375340|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||change in Z-Score||Standard Deviation|Mean
1375386|NCT01505764|Secondary|Stair Climbing Power|Percent change from baseline|day 84|only two subjects in each group completed this outcome|||percentage change||Standard Deviation|Mean
1375341|NCT01506726|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:~“In the past month, on average, have you been feeling unusually tired during the day?” is answered “yes” and indicated as “all of the time” or “most of the time.”~“In the past month, on average, have you felt unusually weak?” is answered “yes” and indicated as “all of the time” or “most of the time.”~Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.~The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at month 6 as reported by the subject."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
1375342|NCT01506726|Secondary|Change in Cognitive Outcome Measures-Trail Making Test Part B|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to month 6.|baseline; 6 months|Two subjects in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||second per completed circle||Standard Deviation|Mean
1375343|NCT01506726|Secondary|Change in Serum Hepcidin Levels|To compare the change in serum hepcidin levels between treatment groups and whether such a change is proportional to the decline in IL-6 levels. Change in the hepcidin from prior to study drug to 6 months. Positive changes represent increases in hepcidin levels and negative changes represent decreases.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and 3 subjects in the placebo arm are missing outcome measures.|||ng/ml||Standard Deviation|Mean
1375344|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by increasing erythropoietin (Epo) in UAE subjects. Change in the Epo from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.|||mIU/ml||Standard Deviation|Mean
1375345|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces markers of inflammation including IL-6 and Tumor Necrosis Factor Receptor1 (TNF-R1) in UAE subjects. Change in the marker from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.|||pg/ml||Standard Deviation|Mean
1375346|NCT01506726|Other Pre-specified|Association Between Change in Hemoglobin and Change in Markers of Inflammation.|To examine whether there is an association between change in hemoglobin and changes in markers of inflammation from prior to study drug to 6 months. Inflammatory markers to be measured are iL-6, Tumor Necrosis Factor alpha Receptor1 (TNF-R1), and C-reactive protein (CRP) in anemia subjects.Correlation between change in the inflammatory markers and the change in HB from prior to study drug to 6 months.|prior to study drug; 6 months|One subject from the active drug oral salsalate group and 2 subjects from the placebo arm group are missing outcomes.|||correlation coefficient|||Number
1375347|NCT01506726|Other Pre-specified|Change in the 6 Minute Walk Test (6MWT) Distance.|To assess the impact of treatment of anemia with oral salsalate will improve 6 minute walk test (6MWT) distance from baseline to 6 months as measured in meters and centimeters.|baseline; 6 months|Two subjects were missing outcome measure in both the active drug and the placebo arm.|||meters||Standard Deviation|Mean
1375348|NCT01506726|Primary|Change in Hemoglobin Level From Baseline to 6 Month Visit|To test whether the administration of oral salsalate to a subset of elderly subjects with unexplained anemia (UAE) and high interleukin (IL-6) levels will improve hemoglobin level|baseline; 6 months||||g/dL||Standard Deviation|Mean
1375349|NCT01506596|Secondary|Overall Survival (OS)|OS was measured from date of consent until time of death from any cause, up to 32 months.|Date of Consent until death, up to 32 months||||months||95% Confidence Interval|Median
1375350|NCT01506596|Secondary|Duration of Response|Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.|Measure of the amount of time that the criteria for response per RECIST are first met until disease progression|Since so few patients experienced a response, the pre-specified endpoint of duration of response was not analyzed.||||||
1375351|NCT01506596|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Date of consent until end of study treatment, up to 32 months||||percentage of participants|||Number
1375352|NCT01506596|Secondary|Progression Free Survival (PFS)|PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months.|Date of Consent until progression or death, up to 27 months||||months||95% Confidence Interval|Median
1375353|NCT01506596|Primary|12-week Progression Free Rate|Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion.|Assessed after 12 weeks of study treatment||||percentage of participants||95% Confidence Interval|Number
1375355|NCT01506479|Secondary|6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score|Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.|Baseline and 6 months|Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included.|||units on the UPDRS Motor scale||95% Confidence Interval|Mean
1375356|NCT01506479|Primary|Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise|To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.|9 to 26 weeks|Only for participants who contributed heart rate monitor data.|||percentage of maximum heart rate||95% Confidence Interval|Mean
1375357|NCT01506362|Secondary|Proportion of Patients With Mucosal Healing After Completion of Study Treatment Defined as Reduction in Endoscopy Subscore of ≥ 1 From Baseline & an Absolute Endoscopy Subscore of ≤ 1 Assessed by Flexible Sigmoidoscopy.||5 weeks following first administration|||||||
1375358|NCT01506362|Primary|Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus ≥ 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of ≤ 1|"Mayo score assesses stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment. It is assessed according to the following parameters:~Stool frequency (subscore 0-3) 0: Normal number of stools for patient~1 to 2 stools per day more than normal~3 to 4 stools more than normal~> or = to 5 stools more than normal~Rectal bleeding (subscore 0-3) 0: No blood seen~Streaks of blood with stool less than half the time~Obvious blood with stool most of the time~Blood alone passes~Endoscopic findings (subscore 0-3) 0: Normal or inactive disease~1 Mild Disease (erythema, decreased vascular pattern, mild friability) 2: Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3: Severe Disease (spontaneous bleeding, ulceration)~Physician's Global Assessment (subscore 0-3) 0: Normal~Mild disease~Moderate disease~Severe disease"|From Baseline to day 34 (end of treatment period)||||participants|||Number
1375359|NCT01506323|Secondary|Five Facet Mindfulness Questionnaire (FFMQ)|FFMQ a 39-item scale that measures five components of mindfulness: observing; describing; acting with awareness; non-judging of inner experience; and non-reactivity to inner experience. Each subscale contains either 7 or 8 items that are rated on a 1 (never or very rarely true) to 5 (very often or always true) Likert scale. Items are randomly reversed scored and higher scores represent greater levels of mindfulness. Total scores range from 39 to 195.|Baseline to post-treatment (week 8); baseline to 2-months follow-up.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375360|NCT01506323|Secondary|Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)|The FACIT-SpEx was developed to assess spiritual components (e.g., harmony, meaning, purpose in life, peacefulness, faith/assurance) of quality of life using 23 items rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Total scores range from 0 to 92. Higher scores indicating greater spiritual well-being. Validity has been demonstrated by significant Pearson correlations between measures of quality of life, mood, and religious growth. It has demonstrated internal consistency reliability.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375361|NCT01506323|Secondary|Spielberger Trait Anger Inventory-Short Form|Spielberger Trait Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale used to measure anger as a personality trait. Scores range from 10 to 40 with higher scores indicating more trait anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375362|NCT01506323|Primary|PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]|PCL-M: PTSD Checklist-Military version (PCL-M) is a 17-item self-report screening instrument for PTSD symptoms related to military trauma. Items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Total scores range from 17 to 85. Higher scores indicate greater symptom bothersomeness. A score of > 50 can suggest PTSD Test-retest reliability is high (r = 0.96) and validity is adequate, with a Kappa of 0.64 agreement for PTSD diagnosis compared to the Structured Clinical Interview for DSM-IV.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375363|NCT01506323|Secondary|Spielberger State Anger Inventory-Short Form|Spielberger State Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale to measure anger as an emotional state. Scores range from 10 to 40 with higher scores indicating more anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375364|NCT01506323|Secondary|Patient Health Questionnaire (PHQ-9) for Depression|PHQ-9 is a 9-item depression screening tool based on the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and total scores range from 0 to 27. Higher scores indicate worse depression. A score of 11 or more considered probable depression and 20 or more is considered severe depression. It is well-validated and widely-used in medical settings such as primary care. The PHQ-9 includes the two major symptom domains characteristic of depression: affective and somatic symptoms.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375365|NCT01506323|Secondary|Insomnia Severity Index (ISI)|ISI is a widely used measure of insomnia with well-established reliability and validity. It consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Both categorical and continuous measures of sleep difficulties can be assessed. Items are rated on a 0-4 Likert scale with higher scores meaning greater insomnia. Total scores range from 0-28. Original results were interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia and 21-28 = severe clinical insomnia. Later recommendations for a clinical, not community sample, are a cut-off of 11 points.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375366|NCT01506323|Primary|Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of increased arousal as indicated by two or more of the following: (1) difficulty falling or staying asleep, (2) irritability or outbursts of anger, (3) difficulty concentrating, (4) hypervigilance, and/or (5) exaggerated startle response. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 40. Higher scores indicate greater severity of symptoms.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375367|NCT01506323|Primary|Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: (1) efforts to avoid thoughts, feelings, or conversations associated with the trauma, (2) efforts to avoid activities, places or people that arouse recollections of the trauma, (3) inability to recall an important aspect of the trauma, (4) markedly diminished interest or participation in significant activities, (5) feelings of detachment or estrangement from others, (6) restricted range of affect, and/or (7) sense of a foreshortened future. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 56 with higher scores indicating greater severity of avoidance.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375368|NCT01506323|Primary|Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of (1) recurrent or intrusive recollections of trauma, (2) recurrent, distressing dreams of the trauma, (3) acting as if the traumatic event were recurring like a flashback, (4) intense psychological distress at exposure to internal or external cues that resemble the trauma; and/or (5) physiological reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the trauma. Duration of these symptoms is greater than one month and symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores can range from 0 to 40 and higher scores mean greater severity of re-experiencing.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375369|NCT01506323|Primary|Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)|PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, & excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms. CAPS total score ranges from 0-136 with higher scores indicating greater symptom severity.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
1375370|NCT01506193|Secondary|Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.|At Day 42 after vaccination|The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.|||Titers||95% Confidence Interval|Geometric Mean
1375372|NCT01506193|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
1375373|NCT01506193|Secondary|Number of Subjects Reporting Any, Localised and Generalised Rashes|Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin’s surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin’s surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets for rash completed.|||Participants|||Count of Participants
1375374|NCT01506193|Secondary|Number of Subjects Reporting Fever Per Half Degree|Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1375375|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1375376|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day (Days 0-14) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1375377|NCT01506193|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1375378|NCT01506193|Primary|Number of Seroprotected Subjects for rSBA-MenC Antibodies|Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.|At 42 days after vaccination|The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.|||Participants|||Count of Participants
1375379|NCT01506193|Primary|Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus|Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.|At 42 days after vaccination|The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.|||Participants|||Count of Participants
1375380|NCT01505881|Secondary|Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.|"Clinical efficacy outcome events presented are:~Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis"|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
1375381|NCT01505881|Secondary|Percentage of Patients With Serious AEs|Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
1375382|NCT01505881|Secondary|Percentage of Patients With AEs Leading to Discontinuation of Trial Drug|"Percentage of patients with Adverse Events leading to discontinuation of trial drug.~Prespecified clinical outcome events were not recorded as Adverse Events."|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
1375387|NCT01505764|Secondary|Body Composition.|Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline|day 84|only two subjects in each group completed this outcome|||percentage change||Standard Deviation|Mean
1375396|NCT01505673|Secondary|Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment|Willingness to continue insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.|6 months||||score on a scale||Standard Deviation|Mean
1375397|NCT01505673|Secondary|Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment|Satisfaction with insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.|6 months||||score on a scale||Standard Deviation|Mean
1375398|NCT01505673|Secondary|Quality of Life Survey (QoL) - Social Stigma|Social stigma was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.|6 months||||score on a scale||Standard Deviation|Mean
1375399|NCT01505673|Secondary|Quality of Life Survey (QoL) - Lifestyle Flexibility|Lifestyle flexibility was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.|6 months||||score on a scale||Standard Deviation|Mean
1375400|NCT01505673|Secondary|Quality of Life Survey (QoL) - Glycemia Control Perception|Glycemia control perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1–7, where 1 - extremely controlled and 7 - not at all controlled.|6 months||||score on a scale||Standard Deviation|Mean
1375401|NCT01505673|Secondary|Quality of Life Survey (QoL) - Hypoglycemia Fear|Hypoglycemia fear was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry.|6 months||||score on a scale||Standard Deviation|Mean
1375402|NCT01505673|Secondary|Quality of Life Survey (QoL) - Social or Vocational Worry|Social or vocational worry was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0–5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.|6 months||||score on a scale||Standard Deviation|Mean
1375403|NCT01505673|Secondary|Quality of Life Survey (QoL) - Treatment Impact|Treatment impact was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|6 months||||score on a scale||Standard Deviation|Mean
1375404|NCT01505673|Secondary|Quality of Life Survey (QoL) - Treatment Satisfaction|Quality of Life Survey (QoL) - treatment satisfactionTreatment satisfaction was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|6 months||||score on a scale||Standard Deviation|Mean
1375405|NCT01505673|Secondary|Quality of Life Survey (QoL) - Current Health Perception|Current health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.|6 months||||score on a scale||Standard Deviation|Mean
1375406|NCT01505673|Secondary|AUC Glucose||6 months||||mg/(dL/min)||Standard Deviation|Mean
1375407|NCT01505673|Secondary|Ratio (AUC C-peptide/AUC Glucose)||6 months||||Ratio||Standard Deviation|Mean
1375408|NCT01505673|Secondary|Beta-cell Function|AUC c-peptide|6 Months||||ug/(L/min)||Standard Deviation|Mean
1375409|NCT01505673|Secondary|Matsuda Index as a Measure of Beta Cell Function|The Matsuda index is a measure of insulin sensitivity and has no minimum/maximum values. Index values are calculated as 500,000/square root of ((fasting glucose x fasting c-peptide x 333) x (mean 120 min post-meal glucose x mean 120 min post-meal c-peptide x 333)). Higher/lower values = better/worse insulin sensitivity.|6 months||||index||Inter-Quartile Range|Mean
1375410|NCT01505673|Secondary|Beta-Cell Function|Fasting C-peptide as a Measure of Beta-Cell Function|6 months||||microgram/L||Standard Deviation|Mean
1375411|NCT01505673|Secondary|Quality of Life Survey (QoL) - General Health Perception|General health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1–5, where 1 = excellent; 2 = very good; 3 = good; 4 = fair; 5 = poor.|6-months||||score on a scale||Standard Deviation|Mean
1375412|NCT01505673|Secondary|Hypoglycemic Events|Reported as hypoglycemic events per month by patient as any blood glucose <70 mg/dl or symptoms of hypoglycemia with blood glucose >70 mg/dl|6-months||||events per month per patient||Inter-Quartile Range|Median
1375413|NCT01505673|Secondary|Liver Function Blood Test||6-months||||U/L||Standard Deviation|Mean
1375414|NCT01505673|Secondary|Lipid Profile||6-months||||mg/dL||Standard Deviation|Mean
1375415|NCT01505673|Secondary|Blood Pressure||6-months||||mmHg||Standard Deviation|Mean
1375423|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 182 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.|||Participants|||Number
1375424|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.|||Participants|||Number
1375425|NCT01505647|Secondary|Number of Participants With One or More Adverse Experiences (AEs)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.|||Participants|||Number
1375426|NCT01505647|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).|Day 1 (Baseline) to Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster.|||Ratio||95% Confidence Interval|Geometric Mean
1375427|NCT01505647|Primary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster|||Units/mL||95% Confidence Interval|Geometric Mean
1375428|NCT01505608|Secondary|Median Overall Survival (OS) of Participants|To determine OS and clinical benefit (CR/PR/SD) in this population|3 years|Not evaluated due to early closure. Study data does not exist.||||||
1375429|NCT01505608|Secondary|Progression Free Survival (PFS) of Participants Using Days Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|Arm A- 2 subjects randomized to TMZ+I. Arm B- 6 evalubale patients in Phase 1 + 4 evaluable patients in Phase 2- all received TMZ+I+TPI|||Days|||Number
1375430|NCT01505608|Secondary|Measure Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|Evaluate the impact on QOL of children receiving TPI+I+TMZ|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
1375431|NCT01505608|Secondary|Pharmacokinetics (PK) of TPI 287 in the Phase I Population of This Trial.|To evaluate the drug levels and pharmacokinetics (PK) of TPI 287 from blood samples at multiple time points within the first 24 hours on study.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
1375432|NCT01505608|Primary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|"Phase I portion of trial- All patients enrolled to recieve TPI+I+TMZ. These patients will be added to the Phase II patients that were randomized to Arm B- Arm with TPI 287 (recieved same tx as Phase I participatns).~Phase II portion of trial- TPatients enrolled to this portion (different patients than enrolled to Phase 1) were randomized to Arm A: I+TMZ OR Arm B: TPI+I+TMZ Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|3 years|"8 enrolled to Phase 1: two were non-evaluable =6 move to analysis. Another 4 randomized to Arm B with TPI 287 in Phase 2=10 evaluable in TPI 287 analysis.~2 subjects were enrolled in the Phase 2 randomized portion of the trial to Arm A- without TPI 287. This makes 2 evaluable subjects in this analysis population (did not receive TPI 287)."|||participants|||Number
1375433|NCT01505608|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma.~Phase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized to TPI 287."|6 months|This group includes the 8 patients enrolled to phase 1 TPI 287 portion of the study plus the 4 additional patients randomized to TPI 287 in the Phase 2 portion = 12 patients total that received TPI 287 on this study.|||participants|||Number
1375434|NCT01505530|Secondary|Number of Participants With Anti-LY2495655 Antibodies||Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1|All randomized participants.|||Participants|||Count of Participants
1375435|NCT01505530|Secondary|Change in Pain Scale Physical Functioning|The 36-item Short-Form Health Survey (SF-36) pain scale is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The PCS physical functioning domain score ranges from 0 to 100 (higher scores indicate better health status).|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All randomized participants with evaluable SF-36 domain scores.|||units on a scale||Standard Deviation|Mean
1375436|NCT01505530|Secondary|Change in Patient Reported Outcomes (PRO)|Data from PRO scales are not be presented. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|Zero participants analyzed. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.||||||
1375437|NCT01505530|Secondary|Change in Physical Performance Measures Using Stair Climbing Time (StC)|Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep).|Baseline, Cycles 3, 5, 7, 9 and 11; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||joule/second||Standard Deviation|Mean
1375438|NCT01505530|Secondary|Change in Physical Performance Measures Using the 6 Minute Walk Test|The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||meter||Standard Deviation|Mean
1375439|NCT01505530|Secondary|Change in Physical Performance Measures Using the Time Up and Go (TUG) Test|Time Up and Go (TUG) is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||seconds||Standard Deviation|Mean
1375440|NCT01505530|Secondary|Change in Physical Performance Measures Using Hand Grip Strength|Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||kilogram (kg)||Standard Deviation|Mean
1375441|NCT01505530|Secondary|Change in Lean Body Mass|Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).|Baseline, Cycles 3, 5, 7, 9 and 11; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||grams (g)||Standard Deviation|Mean
1375442|NCT01505530|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR) was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.|First CR or PR to Disease Progression (Up to 11 months)|All randomized participants.|||months||90% Confidence Interval|Median
1375443|NCT01505530|Secondary|Percentage of Participants With Tumor Response Rate (RR)|Response rate (RR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to Disease Progression (Up to 11 months)|All randomized participants.|||percentage of participants|||Number
1375444|NCT01505530|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Baseline to Disease Progression or Death from Any Cause (Up to 16 months)|All randomized participants.|||months||90% Confidence Interval|Median
1375445|NCT01505530|Primary|Overall Survival (OS)|Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.|Baseline to Death from Any Cause (Up to 23 months)|All randomized participants. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive. Censored participants; 300 mg LY2495655 = 9,100 mg LY2495655 =13, Placebo= 16.|||months||90% Confidence Interval|Median
1375446|NCT01505465|Secondary|Melatonin Effects on Patient Controlled Analgesia and Postoperative Narcotic Usage|A 25% in narcotic usage will be considered clinically important|Up to 3 days|DATA NOT COLLECTED||||||
1375447|NCT01505465|Secondary|Melatonin Effects on Daytime Activity|A 20% difference will be considered clinically important.|Up to postoperative day 3|DATA NOT COLLECTED||||||
1375448|NCT01505465|Secondary|Melatonin Effects on Delirium During Post-operative Inpatient Stay Based on Clinical Assessment in Patients 65 and Older|A difference of 25% will be considered clinically important.|Up to postoperative day 3|DATA NOT COLLECTED||||||
1375449|NCT01505465|Secondary|Perioperative Effects of Melatonin on Post-operative Pain Scores|A difference in 25% in average pain score at each time point be considered clinically significant.|Up to postoperative day 3|DATA NOT COLLECTED||||||
1375450|NCT01505465|Primary|Perioperative Sleep Efficiency|Sleep time change from 96 hours before surgery to 72 hours after surgery|96 hours before surgery to 72 hours after surgery||||minutes||Inter-Quartile Range|Mean
1375451|NCT01505387|Secondary|Blood Pressure|Measured in mm Hg|24 weeks|||||||
1375452|NCT01505387|Secondary|Full Blood Count|Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)|24 weeks|||||||
1375453|NCT01505387|Secondary|Body Mass Index (kg/m^2)|Changes from baseline to end of study|24 weeks|||||||
1375454|NCT01505387|Secondary|Waist and Hip Circumference (cm)|Changes from baseline to end of study|24 weeks|||||||
1378767|NCT01468896|Secondary|Overall Survival (Phase II)|The Kaplan-Meier method will be used to estimate overall survival distribution.|From the date of registration to date of death, assessed up to 1 year||||months||95% Confidence Interval|Median
1375463|NCT01505166|Other Pre-specified|Number of Alive Subjects (Part 1)|For Part 1, this was to determine the overall survival rate in patients with CLM following resection +/= ablation with curative intent treated with adjuvant chemotherapy and Vigil™ by following these patients up to 24 months.|24 Months|3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. After 24 months, 2 subjects were still alive and 1 subject was dead. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
1375464|NCT01505166|Other Pre-specified|Enzyme-Linked ImmunoSorbent Spot (ELISPOT) (Part 1)|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.|Baseline, End of Treatment (30 days after last dose) up to 12 months|3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. After 12 months, all 3 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
1375465|NCT01505166|Primary|Percent of Patients Who Survived After Treatment (Part 2)|To determine and compare the overall survival rate in patients with CLM following resection +/- ablation with curative intent treated with sandwich or adjuvant chemotherapy and Vigil™ vaccine versus sandwich or adjuvant chemotherapy and placebo and compare with historical data.|24 months|This outcome measure was for Part 2. No subjects were randomized in Part 2. This study was terminated.||||||
1375466|NCT01505166|Primary|Percent of Patients Who Progressed After Treatment (Part 2)|Response rate will also be evaluated in this study using the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.The response in patients with measurable disease will be reported using standard outcome measures for clinical trials: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Any response to treatment (either PR or CR) requires two confirmatory staging at least 4 weeks apart. Patients will be evaluable for tumor response if measurable disease is present.|24 months|This outcome measure was for Part 2. No subjects were randomized in Part 2. This study was terminated.||||||
1375467|NCT01505166|Primary|Immune Analysis in Tumor Biopsy and Blood (Part 1)|To evaluate and correlate Tumor Infiltrating Lymphocytes (TIL) in initial excised tumor and Enzyme-Linked ImmunoSorbent Spot (ELISPOT) responses to Vigil™ vaccine in blood of patients with CLM.|Up to 12 months|3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. However, TIL was not tested/collected so no correlation could be performed. Statistical analysis was not done. This study was terminated.||||||
1375468|NCT01505114|Primary|Occurrence of Grade 3 or Higher Adverse Events (AEs)|participants had Occurrence of Grade 3 or higher adverse events (AEs)|Through Week 48||||Participants|||Count of Participants
1375469|NCT01504997|Secondary|Incidence of Adverse Events||Participants will be followed for the duration of hospital stay, an expected average of 10 days|||||||
1375470|NCT01504997|Secondary|Completion Rate of Robot Assisted Surgery||During the surgery, an expected average of 5 hours|||||||
1375471|NCT01504997|Secondary|Relapse Free Survival||5 years|||||||
1375472|NCT01504997|Secondary|Overall Survival||5 years|||||||
1375473|NCT01504997|Primary|The Incidence of Post-operative Intra-abdominal Infectious Complications||Participants will be followed for the duration of hospital stay, an expected average of 10 days||||participants||90% Confidence Interval|Number
1375474|NCT01504971|Secondary|Association of Each Endoscopic Finding With Treatment Effect of PPI|Treatment effect of PPI is assessed by changes of symptom score|2 month|||||||
1375475|NCT01504971|Secondary|Association of Each Endoscopic Finding With pH Monitoring Result||1 month|||||||
1375476|NCT01504971|Secondary|Association of Each Endoscopic Finding With Symptom Score|Symptom score is assessed by a self-reported questionnaire|1 month|||||||
1375477|NCT01504971|Primary|Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.|Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month|1 month||||percentage of participants||95% Confidence Interval|Number
1375478|NCT01504958|Secondary|Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)|23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline.|Pre-treatment, 1 month Post-treatment||||percent change||Standard Deviation|Mean
1375479|NCT01504958|Secondary|Clinical Global Impression of Change (CGIC)|The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline.|Pre-treatment, 1 month post treatment||||percent change||Standard Deviation|Mean
1375480|NCT01504958|Primary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score).|Pre treatment; 1 month post treatment||||percentage change||Standard Deviation|Mean
1375481|NCT01504867|Secondary|Mean Hospital Length of Stay||approximately 7 days|Intention-to-Treat|||days||Standard Deviation|Mean
1375482|NCT01504867|Secondary|Number of Subjects Admitted to Intensive Care Unit (ICU)||7 days|Intention-to-Treat|||participants|||Number
1375483|NCT01504867|Secondary|Mean Number of Days Participants Were Ventilator-Free To Day 28||baseline, Day 28|Intention-to-Treat|||days||Standard Deviation|Mean
1375484|NCT01504867|Secondary|Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization||approximately 7 days|Intention-to-Treat|||participants|||Number
1375485|NCT01504867|Secondary|Number of Participants With ARDS or Mortality Within 7 Days||within 7 days||||participants|||Number
1375486|NCT01504867|Secondary|Hospital Mortality||28 days|Intention-to-Treat|||participants|||Number
1376140|NCT01496274|Secondary|The Frequency of Related Adverse Events|The percentage of participants experiencing treatment-related adverse-events (TEAEs).|For the duration of the study; median 20.27 months.|Safety Population|||Percentage of participants|||Number
1375487|NCT01504867|Primary|Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days|ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.|Within seven days from hospital presentation|Intention-to-Treat|||participants|||Number
1375488|NCT01504854|Secondary|Comparison of the Response to Treatment of Resveratrol Based on ApoE Genotype|CSF Abeta40|Week 52|ITT analyses. Total population and subpopulation of ApoE4 non-carriers.|||ng/ml||Standard Deviation|Mean
1375489|NCT01504854|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|The ADCS-ADL is an activities of daily living inventory developed by the ADCS to assess functional performance in participants with AD. The ADCS-ADL includes some items from traditional basic ADL tests (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as instrumental (complex) activities of daily living (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading). This structured questionnaire is administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|Week 52||||units on a scale||Standard Deviation|Mean
1375490|NCT01504854|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)|MRI will be used to assess the effect of treatment on rate of whole brain volume|Baseline and Week 52|ITT population|||cm^3||Standard Deviation|Mean
1375491|NCT01504854|Primary|Number of Adverse Events|The safety and tolerability of treatment with resveratrol will be assessed by analysis of adverse events, including symptoms, abnormal findings on physical examinations, standard laboratory tests and PK analysis of resveratrol and its major metabolites. The frequencies of adverse events or laboratory abnormalities between the participants who receive resveratrol and those receiving placebo will be compared.|Baseline, Weeks 6, 13, 19, 26, 32, 39, 45, and 52|ITT population|||number of AEs|||Number
1375492|NCT01504854|Post-Hoc|Change From Baseline in Cerebrospinal Fluid Amyloid β40 Concentration at 52 Weeks|Mean change from baseline in cerebrospinal fluid amyloid β40 concentration at 52 weeks|Baseline and Week 52|Post-hoc modified intention-to-treat (ITT) re-analysis of primary outcomes at Week 52 adjusting for age and AD duration in the mixed-model repeated measures model|||ng/ml||Standard Deviation|Mean
1375493|NCT01504204|Secondary|Change in Acne Lesion Count|Change in total count of acne lesions from baseline visit to Week 6 visit|Baseline and 6 weeks||||lesions||Full Range|Mean
1375494|NCT01504204|Secondary|Change in Acne Global Assessment|Change in the physician's global assessment of acne severity on a validated 0-5 scale (0=clear to 5=very severe) from baseline to Week 6 visit.|Baseline and 6 weeks||||Participants|||Count of Participants
1375495|NCT01504204|Primary|Adherence to Study Medication|Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.|Baseline to 6 weeks|the median and ranges of subject ages for the sample and no sample group were 19 years, primarily female identifying as Caucasian.|||percentage of doses||Standard Deviation|Median
1375496|NCT01503749|Secondary|Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score|The efficacy (mean change in Child-Pugh score and Model For End-Stage Liver Disease score [at weeks 24]) of ultrasound-guided percutaneous portal transplantation of peripheral blood monocyte cell in cirrhotic patients. MELD Score = (0.957 * ln(Serum Cr) + 0.378 * ln(Serum Bilirubin) + 1.120 * ln(INR) + 0.643 ) * 10 (if hemodialysis, value for Creatinine is automatically set to 4.0) (minimum <9: 1.9% mortality; maximum 40 or more: 71.3% mortality). Child-Pugh score = Bilirubin (mg/dl): <2 (1 point),2-3 (2 points), >3 (3 points) + Albumin (g/dl): >3.5 (1 point),3.5-2.8 (2 points), <2.8 (3 points) + PT prolongation (INR): <4 seconds (<1.7) (1 point), 4-6 seconds (1.7-2.3) (2 points),>6 seconds (>2.3) (3 points) + Ascites: Absent (1 point), Slight (2 points), Moderate (3 points) + Encephalopathy: Absent (1 point), Mild (I-II) (2 points), Severe (III-IV) (3 points) ; Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15; higher Child-Pugh score with worse prognosis)|Baseline and Week 24|A total of 9 decompensated cirrhotic patients (5 men and 4 females, age range 45–71 years) grouped by randomization.|||score||Standard Deviation|Mean
1375497|NCT01503749|Primary|Number of Participants With Severe Adverse Events|No serious adverse event. Minor adverse events (not considered to be related to this study), as follows; Control: 6 events (ascites and pleural tapping, gum bleeding, ascties tapping x3, diarrhea) G-colony stimulating factor group: 6 events (percutaneous vertebroplasty, abdominal pain and nausea, hyperkalemia, ascties tapping, diarrhea, liver transplantation) Infusion of the mobilized peripheral blood mononucleated cells group: 1 event (hepatic encephalopathy)|up to 6 months|Nine patients who fulfilled the inclusion and exclusion criteria.|||participants|||Number
1375498|NCT01503164|Secondary|Area Under the Curve Assessed by Oral Glucose Tolerance Test (OGTT)|Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over a 2 hour period 2 months post intervention. This will be the area under the glucose/ insulin curves|2 month after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||mg/dL per 120 min||Standard Deviation|Mean
1375499|NCT01503164|Secondary|Area Under the Curve Assessed by Oral Glucose Tolerance Test|Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over the 2 hour period. This will be the area under the glucose/ insulin curves|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||mg/dL per 120 min||Standard Deviation|Mean
1375500|NCT01503164|Secondary|Endothelial Function|Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.|2 month after intervention|Data was not collected for all participants for this outcome measure. Participants for whom data was available are included in analysis.|||ratio||Standard Deviation|Mean
1375501|NCT01503164|Secondary|Endothelial Function|Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.|Baseline|Data was unable to be collected for all participants in this outcome measure.|||ratio of occluded versus non-occluded||Standard Deviation|Mean
1375782|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
1375502|NCT01503164|Secondary|Acute Insulin Response to Glucose (AIRG)|The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L-min]||Standard Deviation|Mean
1375503|NCT01503164|Secondary|Acute Insulin Response to Glucose (AIRG)|The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L-min]||Standard Deviation|Mean
1375504|NCT01503164|Secondary|Disposition Index (DI)|The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1] x [mU/L-min]||Standard Deviation|Mean
1375505|NCT01503164|Secondary|Disposition Index (DI)|The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data. A low DI is indicative of a higher risk of developing diabetes.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1] x [mU/L-min]||Standard Deviation|Mean
1375506|NCT01503164|Secondary|Glucose Effectiveness (SG)|Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[min]^-1||Standard Deviation|Mean
1375507|NCT01503164|Secondary|Glucose Effectiveness (SG)|Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[min]^-1||Standard Deviation|Mean
1375508|NCT01503164|Primary|Insulin Sensitivity (SI)|"Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time zero. After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the minimal model (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity."|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1||Standard Deviation|Mean
1375509|NCT01503164|Primary|Insulin Sensitivity (SI)|"Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time zero. After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the minimal model (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity."|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1||Standard Deviation|Mean
1375510|NCT01503021|Other Pre-specified|Incidence of Patients Meeting Hy's Law Criteria|The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||participants|||Number
1375511|NCT01503021|Other Pre-specified|Transferrin Saturation|The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percent transferrin saturation||Standard Deviation|Mean
1375512|NCT01503021|Other Pre-specified|Serum Iron|The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
1375513|NCT01503021|Other Pre-specified|Ferritin|The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micrograms per liter||Standard Deviation|Mean
1375514|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percent transferrin saturation||Standard Deviation|Mean
1375515|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percent transferrin saturation||Standard Deviation|Mean
1375516|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
1375517|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
1375518|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
1375519|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
1375520|NCT01503021|Secondary|Incidence of Serious Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375521|NCT01503021|Secondary|Incidence of Systemic/Serious Infections|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375522|NCT01503021|Secondary|Incidence of Other Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375523|NCT01503021|Secondary|Incidence of Hemodialysis Vascular Access Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375524|NCT01503021|Secondary|Incidence of Composite Cardiovascular Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375525|NCT01503021|Primary|Incidence of Related Suspected Hypersensitivity Reactions|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375557|NCT01502410|Secondary|The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity,|Each patient is classified as having experienced grade 3 or higher CTC version 4 toxicity if at any time during protocol therapy such an event is observed for the individual.|six cycles of chemotherapy; expected to be 126 days of treatment|All eligible patients diagnosed with Rhabdomyosarcoma or Wilms Tumor are combined in this analysis.|||Participants|||Count of Participants
1375526|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375527|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
1375528|NCT01502956|Secondary|Quality of Life (HUI-3)|Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the Health Utility Index, Version 3 (HUI-3). The HUI 3 scale has a range from 0 to 1 with higher scores representing better health.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
1375529|NCT01502956|Secondary|Quality of Life (IIQ-SF)|Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in the mean Incontinence Impact Questionnaire short form (IIQ-SF) score. The IIQ-SF scale has a range from 0 to 100 with higher scores indicating a worse quality of life.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
1375530|NCT01502956|Secondary|Quality of Life (UDI-SF)|Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in mean Urinary Distress Inventory Short Form (UDI-SF) score. The UDI-SF scale has a range from 0 to 100 with higher scores indicating greater distress.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
1375531|NCT01502956|Secondary|Treatment Satisfaction (OAB-SATq Treatment Preference)|Treatment preference as measured by the Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) at 6 months (6 month assessment).OAB-SATq treatment preference is a binary outcome that is classified as yes if a participant answers either “Slight preference for the treatment I am receiving now” or “Definitely prefer the treatment I am receiving now” to the question “Do you prefer the treatment that you received since entering this study to the treatment you received before the study?”|6 Months|All eligible participants who provided at least 1 postbaseline diary assessment.|||Participants|||Count of Participants
1375532|NCT01502956|Secondary|Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)|Treatment satisfaction as measured by the mean Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) score at 6 months (6 month assessment). The OAB-SATq score ranges from 0 to 100 and includes 5 subscales: treatment satisfaction, side effects, treatment endorsement, convenience, and treatment preference, with higher scores reflecting better satisfaction.|6 months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
1375533|NCT01502956|Secondary|Severity of Urge Incontinence Symptoms|Severity of urge incontinence symptoms at 6 month visit period as measured by the Sandvik questionnaire. The Sandvik score is a patient-reported measure of incontinence severity as assessed on a scale of slight (1-2), moderate (3-6), severe (8-9), very severe (12) to severe (10-12) using a standard scoring algorithm.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||Participants|||Count of Participants
1375534|NCT01502956|Secondary|Urinary Frequency and Nocturia|Change in mean number of urinary incontinence episodes (any type) and nocturia episodes from baseline over the first 6-month visit period (1, 2, 3, 4, 5, and 6-month assessments) as measured by the 3 day bladder diary.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||Number of episodes||95% Confidence Interval|Mean
1375535|NCT01502956|Secondary|Change in Overactive Bladder|Change in mean Overactive Bladder Questionnaire Short Form (OABq-SF) score throughout baseline to the first 6-month visit (1, 2, 3, 4, 5, and 6-month assessments). Values range from 0 to 100 with higher scores on the symptom scale indicating greater severity of symptoms and higher scores on the quality of life scale indicating a better quality of life.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
1375536|NCT01502956|Secondary|Number of Participants With Improvement of Bladder Function and Urinary Leakage|Proportion of subjects who report adequate improvement of their bladder function and urinary leakage with the Patient Global Impression of Improvement Questionnaire (PGI-I) at 6 months. Adequate improvement is defined as a rating of 1, 2, or 3 (better) on the patient-reported measure of perceived improvement with treatment on a scale of 1 (very much better) to 7 (very much worse).|6 Months|All eligible participants who provided at least 1 postbaseline diary assessment.|||Participants|||Count of Participants
1375537|NCT01502956|Primary|Number of Urge Urinary Incontinence (UUI) Episodes|The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||UUI episodes||95% Confidence Interval|Mean
1375538|NCT01502787|Secondary|Blood Pressure During Angiotensin II Infusion||12 weeks after initiation of metoprolol||||mmHg||Standard Error|Mean
1375539|NCT01502787|Secondary|Blood Pressure During Exercise||12 weeks||||mmHg||Standard Error|Mean
1375540|NCT01502787|Primary|Forearm Blood Flow||12 weeks after each specified medication||||ml/min||Standard Deviation|Mean
1375541|NCT01502761|Secondary|Number of Participants With Procedure Related Serious Adverse Event|Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days)|intraprocedure, postoperative day 1, 1 month, 3 month||||Participants|||Count of Participants
1375542|NCT01502761|Primary|Magnesium Concentration in Region of Cerebral Ischemia|Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.|Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever|Enrollment only occurred in the first arm (lowest dose) of the study as the arms were planned to enroll sequentially. The study was not stopped due to safety concerns|||meq/L||Standard Deviation|Mean
1375543|NCT01502709|Secondary|Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam|RDC for Temporomandibular disorders (TMD) is a reliable & valid system for diagnosis of TMD, utilizing clinical procedures, diagnostic algorithms, and a dual-axis assessment comprising symptom history and physical exam. Signs and symptoms were evaluated by a trained professional and the history was obtained through use of questionnaires. In all sections and scales the higher the number reported corresponds to the more pain being experienced, therefore, a worse outcome. The clinical exam consists of facial, dental, and cervical evaluations including mandibular range of motion, Temporomandibular disorders Joint sound, and palpation of the orofacial muscles and temporomandibular joints (TMJ). Subjects are classified as TMD if they report pain in or around the temporomandibular joints or muscles of mastication for more than 3 months.|Baseline, Month 3||||Participants|||Number
1375544|NCT01502709|Secondary|Mean Percentage of Time Spent in Pain From Days 1-7|The mean of measures taken from days 1-7 was calculated. Composite pain is a measure of mean pain intensity experienced and pain duration. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. Duration of pain ranges from 0 to 100% of a day. For example a pain free subject would report O pain intensity for 0% of the day.|Days 1-7||||percentage of day in pain||Standard Deviation|Mean
1375545|NCT01502709|Primary|Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment|The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.|Daily Self-reports at Baseline and on Days 1 through 7||||millimeters||Standard Deviation|Mean
1375546|NCT01502644|Primary|Percent Change in Average Daily Pain Score|Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure. Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure. A positive change from baseline indicates an improvement.|Baseline and Week 20|Modified Intent-to-Treat Population, all participants who completed at least 50% of the opioid treatment period (at least 10 weeks of treatment).|||percent change||Standard Deviation|Mean
1375547|NCT01502423|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious adverse events were collected from the time that participant signed the informed consent.||||participants|||Number
1375548|NCT01502423|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1375549|NCT01502423|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1375550|NCT01502423|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1375551|NCT01502423|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
1375552|NCT01502423|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection.|15 minutes post injection||||cm||Standard Deviation|Mean
1375553|NCT01502423|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection.||||cm||Standard Deviation|Mean
1375554|NCT01502410|Secondary|Presence of BRAF Mutation or RET/PTC Rearrangement|Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline for patients with PTC, TG and TG antibody, and presence of BRAF mutation or RET/PTC rearrangement.|At baseline|No patients were enrolled with PTC (papillary thyroid carcinoma) so there are no patients who can contribute to this outcome measure.||||||
1375555|NCT01502410|Secondary|Change in VEGF and VEGFR-2|Serum VEGF and VEGF receptor 2 Concentration is evaluated at baseline and at day 15 of protocol therapy in picograms/ml.|Prior to the administration of sorafenib (baseline) and day 15 of protocol therapy|Change in VEGF and VEGFR-2 are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed, and were combined for analysis.|||picograms/ml||Full Range|Mean
1375556|NCT01502410|Secondary|Pharmacokinetic (PK) Parameters of Sorafenib Tosylate|The trough sorafenib concentration is evaluated at baseline (prior to administration of Sorafenib) and 12 hours after administration of Sorafenib on day 15, day 56, day 112 and day 168 in micrograms/ml.|Prior to administration of Sorafenib (baseline), day 15, day 56, day 112 and day 168|Baseline sample was available for only 9 participants.|||micrograms/ml||Full Range|Mean
1380388|NCT01455519|Secondary|Change in Treadmill Distance Walked|Treadmill distance walked in 6 minutes|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||miles||Standard Error|Mean
1375558|NCT01502410|Secondary|Progression-free Survival According to RECIST Version 1.1|Percent probability of being progression free six months following enrollment. Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.|Six months after enrollment|All eligible patients are included in this analysis for both Rhabdomyosarcoma and Wilms Tumor. However, there were no accruals on the disease arms for Hepatocellular carcinoma and Papillary Thyroid carcinoma and were not included in this analysis.|||percentage of probability||95% Confidence Interval|Number
1375559|NCT01502410|Primary|Objective Response by RECIST Criteria v 1.1|Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 cycles (168 days)|Only Rhabdomyosarcoma and Wilms Tumor patients are included in this analysis as there were no accruals on Hepatocellular carcinoma and no accruals on Thyroid carcinoma.|||participants|||Number
1375560|NCT01502371|Secondary|Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI 50 mcg or MF DPI were included in this secondary analysis.|||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
1375561|NCT01502371|Secondary|Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo|The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1375562|NCT01502371|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo|PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.|||Liters/minute||95% Confidence Interval|Least Squares Mean
1375563|NCT01502371|Primary|Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.|Baseline and Week 12|The Full Analysis Set (FAS) population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI or Placebo were included in this primary analysis.|||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
1375564|NCT01502332|Secondary|Hospital Mortality|Deaths occurred during hospital stay, tested with logistic regression.|From the day of surgery up to Hospital discharge or death, with no maximum censoring.||||percentage of participants|||Number
1375565|NCT01502332|Secondary|Incidence of Barotrauma|Confirmed by X-ray. Test with logistic regression|Five days after surgery||||percentage of participants|||Number
1375566|NCT01502332|Secondary|Length of Hospital Stay|Days since surgery until Hospital discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the Hospital. The censoring was performed at 28 days. Patients dying before leaving the Hospital were censored as not discharged from Hospital at day 28.|From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery||||days||Inter-Quartile Range|Median
1375567|NCT01502332|Secondary|Length of ICU Stay|Days since surgery until ICU discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the ICU. The censoring was performed at 28 days. Patients dying before leaving the ICU were censored as not discharged from ICU at day 28.|From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery||||days||Inter-Quartile Range|Median
1375660|NCT01500434|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Index Procedure|Analysis was intention to treat|||percentage of stents|stents||Number
1385446|NCT01402011|Other Pre-specified|Visual Analog Pain Scale|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. Maximum of pain scores rest, work, sport is recorded.|one month|||||||
1375568|NCT01502332|Primary|Severity of Pulmonary Complications in the Post-operative Period|"Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication.~The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test.~Data shown are percentage of participants with pulmonary complications grade ≥ 3."|Participants were followed for the duration of hospital stay.||||percentage of participants|||Number
1375569|NCT01502228|Secondary|Maximum Standard Uptake Value (SUV) for Lesion Data|Average values of the magnitude of tumor perfusion before and 14-28 days after initiation of Sunitinib treatment as measured by the maximum standard uptake value for all the lesion data. Standard uptake values were calculated as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity tracer. There were 14 patients who had a baseline reading and 12 patients who had a reading after treatment.|Baseline and 14-28 days after initiation of Sunitinib||||SUV||Standard Deviation|Mean
1375570|NCT01502228|Primary|Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained|Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET|Baseline|All Patients Enrolled.|||Participants|||Count of Participants
1375571|NCT01502033|Secondary|The Clinical Global Impression - Improvement (CGI-I)|The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of 30 treatments or after last treatment in case of early withdrawal||||units on a scale||Standard Deviation|Mean
1375572|NCT01502033|Secondary|Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of Treatment 30 or Last Treatment||||units on a scale||Standard Deviation|Mean
1375573|NCT01502033|Primary|Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.|5 days of Treatment 30 or Last Treatment||||units on a scale||Standard Deviation|Mean
1375574|NCT01501955|Secondary|SF-12 Mental Summary Score|SF-12 Score presented in Physical and Mental summary scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the SF-12 Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
1375575|NCT01501955|Secondary|SF-12 Physical Summary Score|"12-Item Short-Form Health Survey (SF-12) presented in Physical (PS) and Mental summary (MS) scores (range 0-100).~A zero score indicates the lowest level of health and 100 indicates the highest level of health."|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the SF-12 Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
1375576|NCT01501955|Secondary|WOMAC Function|"WOMAC Score presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the WOMAC Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
1375577|NCT01501955|Secondary|WOMAC Stiffness|"Western Ontario and McMaster Osteoarthritis Index (WOMAC) presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the WOMAC Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
1375578|NCT01501955|Secondary|WOMAC Pain|WOMAC Score presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the WOMAC Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
1375579|NCT01501955|Secondary|HOOS-QoL Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
1385447|NCT01402011|Other Pre-specified|Visual Analog Pain Scale|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.|two months|||||||
1375580|NCT01501955|Secondary|HOOS-Sport Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
1375581|NCT01501955|Secondary|HOOS-ADL Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
1375582|NCT01501955|Secondary|HOOS-Symptom Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
1375583|NCT01501955|Secondary|HOOS-Pain Subscale|HOOS (Hip disability and Osteoarthritis Outcome Score) consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
1375584|NCT01501955|Secondary|DEXA|"Efficacy:~Bone density measured using DEXA"|10 years postoperative|||||||
1375585|NCT01501955|Secondary|Harris Hip Score|"Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.~The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0–44 points), function (7 items, 0–47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)"|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the Harris Hip Score was performed for all fully completed score forms.|||Scores on a scale||Standard Deviation|Mean
1375586|NCT01501955|Secondary|Number of Reported Device Related Complications|"Safety:~- Frequency of serious device related complications."|6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment.|||participants|||Number
1375587|NCT01501955|Primary|RSA MTMP|Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
1375588|NCT01501955|Primary|RSA Rotation Z|Stem rotation around the z-axis in degrees (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
1375589|NCT01501955|Primary|RSA Rotation Y|Stem rotation around the y-axis in degrees ( measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
1375590|NCT01501955|Primary|RSA Rotation X|Stem Rotation around X-axis in degrees (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
1375591|NCT01501955|Primary|RSA Translation Z|Stem movement along z-axis in mm (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
1375592|NCT01501955|Primary|RSA Translation Y|Stem movement along the y-axis in mm. (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
1375723|NCT01500109|Primary|Opioid (Fentanyl and Morphine) Consumption|The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in morphine equivalents).|intraoperative period and first postoperative 24 hours||||mcg•kg-1||95% Confidence Interval|Mean
1375593|NCT01501955|Primary|RSA Translation X|Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
1375594|NCT01501162|Secondary|Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines|For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.|7 days after probiotics||||EU/mL||Standard Deviation|Mean
1375595|NCT01501162|Primary|Liver Enzymes(ALT)|Blood analysis was performed using standard methodologies.|7 days after probiotics||||IU/L||Standard Deviation|Mean
1375596|NCT01501110|Primary|Serum T3 Levels at 48 Hours||48 hours||||ng/dL||Standard Deviation|Mean
1375597|NCT01500772|Secondary|Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||48 weeks|The study was terminated before the outcome measure time point.||||||
1375598|NCT01500772|Secondary|Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)|Level of detection (LOD) was defined as 10 IU/mL|12 weeks posttreatment|The study was terminated before the outcome measure time point.||||||
1375599|NCT01500772|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks posttreatment|The study was terminated before the outcome measure time point.||||||
1375600|NCT01500772|Primary|Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)|SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks posttreatment|The study was terminated before the outcome measure time point.||||||
1375601|NCT01500746|Secondary|Pain With Lavage Treatments|After each lavage treatment, the subjects will complete a visual analogue scale that will determine the level of discomfort that they experienced during the study.|4 days|||||||
1375602|NCT01500746|Primary|Change in Gene Expression Analysis|A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated.|4 days|||||||
1375603|NCT01500746|Primary|Change in Bacterial Counts|A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed.|Baseline and at 4 days||||cfu/mL||Full Range|Mean
1375604|NCT01500733|Primary|Overall Response Rate at 6 Months|"The primary endpoint was response after 6 cycles of therapy. Overall response rate was calculated as complete response plus partial response, based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria.as follows:~Complete response (CR): all group A and group B criteria are met~Group A criteria: resolution of enlarged lymph nodes, normal size spleen and liver, absolute lymphocyte count < 4,000/uL, normocellular bone marrow with < 30% lymphocytes without nodules~Group B criteria: improved blood count (platelet count > 100,000/uL, hemoglobin > 11.0 g/dL, neutrophils > 1,500/uL)~Partial response (PR): at least 2 of the group A criteria plus one of the group B criteria are met~Group A criteria: >=50% decrease in target lymph nodes, >=50% decrease in spleen size, >=50% decrease in liver size, 50% reduction in marrow infiltrates~Group B criteria: platelet count > 100,000/uL, hemoglobin > 11.0 g/dL, neutrophils > 1,500/uL"|6 months|The analyses included only those subjects who received ibrutinib, and completed 6 cycles of therapy.|||percentage of participants||95% Confidence Interval|Number
1375605|NCT01500720|Secondary|Overall Objective Tumor Response Rate|Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.|Randomization to disease progression/occurrence (maximum 7.6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1375606|NCT01500720|Secondary|Progression Free Rate at Week 12|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.|Week 12|ITT population.|||percentage of participants||95% Confidence Interval|Number
1375607|NCT01500720|Secondary|Overall Survival|Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.|From randomization to date of death (maximum 15 months)|ITT population.|||months||95% Confidence Interval|Median
1375783|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months||||mmHg||Standard Deviation|Mean
1375608|NCT01500720|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)|Intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
1375609|NCT01500694|Secondary|Number of Participants Assessed With Clinical Global Impression Severity of Illness (CGI-S) Scale|The CGI-S evaluate each participant's severity and improvement over time. The severity of a participant’s condition is rated on a 7-point scale ranging from 1 to 7. The scale measures 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill (BL-MI), 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill participant. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively.|||participants|||Number
1375610|NCT01500694|Secondary|Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment|ADHD-RS-IV was developed to measure the behaviours of children with ADHD with 18 items. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17) with possible score range from 0 (no symptoms) to 27 (most severe symptoms). The ADHD-RS-IV possible total scores range from 0 (no symptoms) to 54 (most severe symptoms). Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively.|||units on a scale||Standard Error|Mean
1375611|NCT01500694|Primary|"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503 with number of participants evaluable for this outcome at specific categories.|||participants|||Number
1375612|NCT01500694|Primary|Change From Baseline in Electrocardiogram Result (QT Interval) at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millisecond (ms)||Standard Deviation|Mean
1375613|NCT01500694|Primary|Change From Baseline in Electrocardiogram Result (QRS Interval) at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millisecond (ms)||Standard Deviation|Mean
1375614|NCT01500694|Primary|Change From Baseline in Mean Weight at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||kilogram (kg)||Standard Deviation|Mean
1375615|NCT01500694|Primary|Change From Baseline in Mean Height at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||centimeter (cm)||Standard Deviation|Mean
1375616|NCT01500694|Primary|Change From Baseline in Mean Supine Pulse at Final Assessment|Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||beats per minute (bpm)||Standard Deviation|Mean
1375724|NCT01500096|Secondary|Number of Participants With Adverse Events in the Ginseng and Placebo Arms|Adverse events (AEs) were assessed from baseline to wk 4 using the NIH Division of AIDS (DAIDS) Grading Toxicity Table, a well known tool used by NIH networks for assessing the severity of AEs in participants enrolled in clinical trials. Reporting the number of participants in each arm who experienced adverse events.|From baseline to week 4 (28 days of study drugs)||||Participants|||Count of Participants
1375617|NCT01500694|Primary|Change From Baseline in Mean Diastolic Blood Pressure at Final Assessment|Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1375618|NCT01500694|Primary|Change From Baseline in Mean Systolic Blood Pressure at Final Assessment|Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication [Visit 19/Early Termination (ET)/Day 714].|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set includes all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1375619|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375620|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375621|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375622|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375623|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||participants|||Number
1375624|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||participants|||Number
1375625|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||participants|||Number
1375626|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes||||participants|||Number
1375627|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375628|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375777|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 6 months||||micromol/l||Standard Deviation|Mean
1375629|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375630|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375631|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375632|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375633|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375634|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375635|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375636|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375637|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375638|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375778|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 1 week||||micromol/l||Standard Deviation|Mean
1375639|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375640|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375641|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375642|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375643|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375644|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375645|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375646|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375647|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375779|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
1375648|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375649|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375650|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375651|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
1375652|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
1375653|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
1375654|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
1375655|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375656|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1375657|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375658|NCT01500629|Primary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes (±5 minutes)|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
1375659|NCT01500434|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death|In hospital (average of 1-2 days post index procedure)|Analysis was intention to treat|||percentage of participants|||Number
1386707|NCT01390038|Secondary|Strength|Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier|24 months||||Pounds||Standard Deviation|Mean
1375661|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|31-365 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375662|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375663|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375664|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375665|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375666|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375667|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375668|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375669|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375670|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375671|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375672|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375673|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375674|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375675|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375676|NCT01500434|Secondary|All Cause Death||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375677|NCT01500434|Secondary|All Cause Death||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375678|NCT01500434|Secondary|All Cause Death||30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375679|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375680|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375681|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375682|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375683|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375684|NCT01500434|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.|||percentage of participants|||Number
1375780|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
1386708|NCT01390038|Secondary|Range of Motion|"Elevation in the scapula plane~Internal rotation with arm at the side~External rotation with arm at the side"|24 months||||Degrees||Standard Deviation|Mean
1375685|NCT01500382|Primary|Number of Participants Who Discontinued Use of Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The AST population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.|||Participants|||Number
1375686|NCT01500382|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The All Subjects as Treated (AST) population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.|||Participants|||Number
1375687|NCT01500382|Secondary|Fold-change From Baseline in Volume of Urine at First Desire to Void Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
1375688|NCT01500382|Primary|Fold-change From Baseline in Maximum Cystometric Capacity Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
1375689|NCT01500317|Secondary|Ascending Colon Emptying (AC t1/2)|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 24 hour data.|Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles||||hours||Standard Deviation|Mean
1375690|NCT01500317|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours||||percentage of radio-labeled meal||Standard Deviation|Mean
1375691|NCT01500317|Primary|Gastric Emptying Half-time (t1/2) at 24 Hours||24 hours||||minutes||Standard Deviation|Mean
1375692|NCT01500317|Secondary|Colonic Geometric Center at 8 and 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|8 hours, 48 hours||||units on a scale||Standard Deviation|Mean
1375693|NCT01500317|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours||||units on a scale||Standard Deviation|Mean
1375694|NCT01500278|Secondary|Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12|Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).|From Week 12 up to Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.|||proportion of subjects|||Number
1375695|NCT01500278|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104|HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.|From Baseline to Week 104|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Units on a Scale||Standard Error|Least Squares Mean
1375696|NCT01500278|Secondary|Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12|"DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.~The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline."|Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12. Only subjects responding at both Week 6 and Week 12 are included in this analysis.|||Percentage of subjects|||Number
1386709|NCT01390038|Secondary|Quality of Life|"Simple Shoulder Test~1 (worse) - 12 (best)"|24 months||||units on a scale||Standard Deviation|Mean
1375697|NCT01500278|Secondary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 12|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
1375698|NCT01500278|Secondary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 6|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
1375699|NCT01500278|Secondary|Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6|Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|Week 6|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
1375700|NCT01500278|Secondary|Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104|"DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.~The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline."|Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.|||Percentage of subjects|||Number
1375701|NCT01500278|Primary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 104|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
1375702|NCT01500278|Primary|Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12|Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|Week 12|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
1375703|NCT01500252|Secondary|Number of Revision Surgeries|This measure examined the number of reoperation in the two groups of subjects|10 years|All participants were analyzed.|||participants|||Number
1375704|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the five-year score from the 10 year score."|5 years postoperative to 10 years postoperative||||units on a scale||Standard Deviation|Mean
1375705|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative||||units on a scale||Standard Deviation|Mean
1375706|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1375707|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative|"This is the change in the patients' perceived pain between preoperative and 5 years postoperative.~The WOMAC stiffness scale has a minimum value of 0 (maximal stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1380389|NCT01455519|Secondary|Change in Stair Climb Time|Time to climb 1 flight of stairs|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||seconds||Standard Error|Mean
1375708|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative|"This measures the change in patients' reported function from preoperative to 5 years postoperative.~The WOMAC Function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1375709|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative||||units on a scale||Standard Deviation|Mean
1375710|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1375711|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1375712|NCT01500252|Primary|Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1375713|NCT01500226|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT|||percentage of participants||95% Confidence Interval|Number
1375714|NCT01500226|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT|||percentage of participants||95% Confidence Interval|Number
1375715|NCT01500226|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT|||percentage of particpants||95% Confidence Interval|Number
1375716|NCT01500213|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT|||percentage of participants||95% Confidence Interval|Number
1375717|NCT01500213|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT|||percentage of participants||95% Confidence Interval|Number
1375718|NCT01500213|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT|||percentage of participants||95% Confidence Interval|Number
1375719|NCT01500135|Secondary|Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. Hemostasis was assessed at 3, 4, and 5 minutes. If hemostasis was not obtained after 5 minutes a second application of IMP was applied with 3 minutes of light pressure and hemostasis was re-assessed at 8, 9 and 10 minutes.|Within 10 minutes|FAS included all randomized participants. Participants who did not achieve hemostasis by 10 minutes were censored.|||minutes||95% Confidence Interval|Median
1375720|NCT01500135|Secondary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.|Within 5 minutes|FAS included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 5 minutes.|||percentage of participants||95% Confidence Interval|Number
1375721|NCT01500135|Primary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.|Within 3 minutes|Full Analysis Set (FAS) included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 3 minutes.|||percentage of participants||95% Confidence Interval|Number
1375722|NCT01500109|Secondary|Pain Scores Using the Age-appropriate Pain Scale|The investigators will also be looking for the presence of pruritus, nausea, vomiting and/or sedation|24 hours|||||||
1375725|NCT01500096|Secondary|Change in PROMIS Fatigue|Questionnaire: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue score from baseline to week 4. Change in PROMIS fatigue score from baseline to Week 4. The change in fatigue as measured by the PROMIS fatigue (Week 4 minus Baseline) using the Wilcoxon test. The PROMIS fatigue is a scale with normalized mean of 50 and standard deviation (SD) of 10. Higher mean values mean more fatigue and negative values indicate less fatigue.|From baseline to week 4 (28 days of study drugs).|There was one missed PROMIS fatigue questionnaire in the ginseng 3000 mg arm.|||units on a scale||Standard Deviation|Mean
1375726|NCT01500096|Secondary|Change in Plasma HIV RNA|Laboratory: Change in plasma HIV RNA from baseline to week 4. A negative value means a drop in plasma HIV RNA.|From baseline to week 4 (28 days of study drugs)||||copies/mL||Standard Deviation|Mean
1375727|NCT01500096|Secondary|Change in CD4 Cell Count|Laboratory: Change in absolute cluster of differentiation 4 (CD4) cell count from baseline to week 5. Negative values mean decline in CD4 cell count.|From baseline to week 5 (28 days of study drugs)||||cells per cubic millimeter||Standard Deviation|Mean
1375728|NCT01500096|Secondary|Inflammatory Markers|Laboratory - Inflammatory Markers (IMs): Change in Interleukin (IL) -6 and soluble receptors of tumor necrosis factor (TNF) α 1 and 2 (sTNFR1 and sTNFR2) from baseline to week 4. Negative values indicate less change in inflammatory markers.|From baseline to week 4 (28 days of study drugs)||||pg/ml||Standard Deviation|Mean
1375729|NCT01500096|Secondary|Changes in Clinical Global Impressions|"Questionnaire: Change in Clinical Global Impressions (CGI) scores from baseline to week 4. CGI is an instrument for making global assessments of worsening or improvement during interventional trials. The subject rates the change in the overall status since beginning the intervention (ranging from: very much improved, much improved, minimally improved, no change, and minimally worse). We assessed the number of participants who rated very much improved."|From baseline to week 4 (28 days of study drugs)||||Participants|||Count of Participants
1375730|NCT01500096|Secondary|Change in Medical Outcomes Study HIV Health Survey|Questionnaire: Change in Medical Outcomes Study (MOS) HIV Health Survey score from baseline to week 4. We evaluated the MOS Energy Fatigue scores; the MOS scale ranges from 0-100; higher scores mean more energy. The MOS was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)||||units on a scale||Standard Deviation|Mean
1375731|NCT01500096|Secondary|Change in Insomnia Severity Index|Questionnaire: Change in Insomnia Severity Index (ISI) score from baseline to week 4. The ISI scale ranges from 0 to 28; higher scores mean worse insomnia while negative scores indicate less insomnia. The ISI was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)|There was one missing ISI in the ginseng 3000 mg arm|||units on a scale||Standard Deviation|Mean
1375732|NCT01500096|Secondary|Change in Patient Health Questionnaire 9|Questionnaire: Change in Patient Health Questionnaire 9 (PHQ9) score from baseline to week 4. The scale for the PHQ9 score ranges from 0 to 27; higher scores mean worse depression; negative scores indicate less depression. We compared PHQ 9 scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. The PHQ9 was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)|There was one missed PHQ9 in the ginseng 3000 mg arm|||units on a scale||Standard Deviation|Mean
1375733|NCT01500096|Secondary|Change in Epworth Sleepiness Scale|Questionnaire: Change in Epworth Sleepiness Scale (ESS) score from baseline to week 4. The ESS is scale ranges from 0 to 24; higher scores mean worse sleep disorder while a negative score indicates less sleep disorder. The ESS was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)|There was one missing questionnaire from the ginseng 3000 arm|||units on a scale||Standard Error|Mean
1375734|NCT01500096|Secondary|Change in the Brief Fatigue Inventory|"Questionnaire: Change in the Brief Fatigue Inventory (BFI) from baseline to week 4. We compared BFI scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. We used the BFI Question that assess Worst Fatigue score: 0 to 90 scale. Higher scores means more fatigue; negative values mean less fatigue.The BFI was used to supplement the data obtained from the FSS."|Change in BFI scores from baseline to week 4 (28 days of study drugs)|There was on missing questionnaire from the ginseng 3000 arm|||units on a scale||Standard Deviation|Mean
1375735|NCT01500096|Primary|Change in Fatigue Severity Score (FSS)|Change in FSS score from baseline to Week 4. The change in fatigue as measured by the FSS (Week 4 minus Baseline) using the Wilcoxon test. The FSS is a scale score ranging from 1 to 63 with higher scores indicative of more fatigue. A negative number indicates a decline in the FSS scale. Participants with FSS data at both times points were assessed.|From baseline to week 4 (28 days of study drugs)|There was one missing scale from the ginseng 3000 arm|||units on a scale||Standard Deviation|Mean
1375736|NCT01500083|Primary|Number of Adverse Events||Up to 266 days|APTS|||number of adverse events|||Number
1375737|NCT01500057|Secondary|Change From Baseline to 12 Months in Post Void Residual Volume|post void residual was measured using a bladder scan device|baseline and 12 months|all participants who completed the study and have available data|||ml||Standard Deviation|Mean
1375738|NCT01500057|Primary|Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)|maximum urinary flow rate was measures using uroflow device|baseline and 12 months|all participants who completed the study and have available data|||ml/sec||Standard Deviation|Mean
1375739|NCT01500057|Primary|Change From Baseline in American Urological Association Symptom Score|The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms|Baseline and 12 months|All people who completed the study and had data available|||units on a scale||Standard Deviation|Mean
1375740|NCT01500031|Other Pre-specified|OffRoad System Use Length of Time|"From time of positioning balloon catheter introduced in the body until time final OffRoad component removed."|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 1 participant was not evaluable (No data available).|||minutes||Standard Deviation|Mean
1375741|NCT01500031|Other Pre-specified|Overall Procedure Time|Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body.|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis.|||minutes||Standard Deviation|Mean
1375742|NCT01500031|Other Pre-specified|Device-related Dissection, Grade C or Greater|"Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material.~Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles.~Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material.~Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow.~Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
1375743|NCT01500031|Other Pre-specified|Target Lesion Revascularization Due to a Complication|Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
1375744|NCT01500031|Other Pre-specified|Acute Procedure Success|Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)}|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
1375745|NCT01500031|Other Pre-specified|All Adverse Events|All adverse events (AEs) reported by the centers.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||adverse events|||Number
1375746|NCT01500031|Other Pre-specified|Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb|"All Major amputations related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
1375747|NCT01500031|Other Pre-specified|Device-related Clinically Significant Peripheral Embolism|"All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
1375748|NCT01500031|Other Pre-specified|Device-related Perforation Requiring Intervention|"All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
1375749|NCT01500031|Other Pre-specified|Device-related Death|All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
1375750|NCT01500031|Primary|Effectiveness (On the Day of Procedure)|Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)|Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis.|||percentage of participants||95% Confidence Interval|Number
1375751|NCT01500031|Primary|Composite Rate of Major Adverse Events|"Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above).~Events are based on data adjudicated by a Clinical Event Committee."|30 days|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day)|||percentage of participants|||Number
1375752|NCT01499862|Primary|Ambulation Speed|Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||meters per second (m/s)|||Number
1375753|NCT01499862|Secondary|Step Length|The length of the patient's average step, in meters, as measured during comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Meters|||Number
1375754|NCT01499862|Secondary|Five Times Sit to Stand Test (5 x STS)|The time, in seconds, for the patient to rise from a seated to full standing position and return to sitting five times in rapid succession. This evaluation is called the Five Times Sit to Stand Test (5 x STS)|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Seconds|||Number
1375755|NCT01499862|Secondary|Timed Up and Go (TUG) Test|The time, in seconds, for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn around, walk back to the chair, and sit down. This evaluation is called the Timed Up and Go test (TUG). The patient may wear their usual footwear and use any aids (canes, walkers, etc.) they typically employ for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Seconds|||Number
1375756|NCT01499862|Secondary|6 Minute Walk Test (6 MWT)|The total distance walked by the patient, in meters, as obtained by the Six (6) Minute Walk Test (6 MWT). The 6 MWT is performed over level ground, using any walking aids (canes, walkers, etc.) the patient requires for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Meters|||Number
1375757|NCT01499849|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rates in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT|||percentage of participants||95% Confidence Interval|Number
1375758|NCT01499849|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours)phase of CINV|0 to 24 hours|MITT|||percentage of participants||95% Confidence Interval|Number
1375759|NCT01499849|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT|||percentage of participants||95% Confidence Interval|Number
1375760|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 6 months|||||||
1375761|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 12 months|||||||
1375762|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000|from baseline to 6 months|||||||
1375763|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)|from baseline to 12 months|||||||
1375764|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 12 months|||||||
1375765|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 6 months|||||||
1375766|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months||||difference between ratios||Standard Deviation|Mean
1375767|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months||||difference between ratios||Standard Deviation|Mean
1375768|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months||||difference between two ratios||Standard Deviation|Mean
1375769|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months||||difference between two ratios||Standard Deviation|Mean
1375770|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 12 months||||no specific units||Standard Deviation|Mean
1375771|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 6 months||||no specific units||Standard Deviation|Mean
1375772|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 1 week||||no specific units||Standard Deviation|Mean
1375773|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 12 months||||g/l||Standard Deviation|Mean
1375774|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 6 months||||g/l||Standard Deviation|Mean
1375775|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 1 week||||g/l||Standard Deviation|Mean
1375776|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 12 months||||micromol/l||Standard Deviation|Mean
1375784|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months||||mmHg||Standard Deviation|Mean
1375785|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months||||mmHg||Standard Error|Mean
1375786|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)|from baseline to 12 months||||mmHg||Standard Error|Mean
1375787|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months||||percentages||Standard Deviation|Mean
1375788|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months||||difference between percentages||Standard Deviation|Mean
1375789|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months||||percentages||Standard Deviation|Mean
1375790|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months||||percentages||Standard Deviation|Mean
1375791|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
1375792|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
1375793|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
1375794|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
1375795|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
1375796|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
1375797|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
1375798|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
1375799|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 12 months|Number of participants assessed by EchoCG at 12 months|||g||Standard Deviation|Mean
1375800|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 6 months|Number of participants assessed by echocardiography (EchoCG ) at 6 months|||g||Standard Deviation|Mean
1375801|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM record|||mmHg||Standard Deviation|Mean
1375802|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM records|||mmHg||Standard Deviation|Mean
1375803|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 6 month||||mmHg||Standard Error|Mean
1375804|NCT01499810|Secondary|Change in Office Systolic BP||from baseline to 6 month||||mmHg||Standard Deviation|Mean
1375805|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ABPM record|||mmHg||Standard Deviation|Mean
1375806|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ambulatory blood pressure monitoring (ABPM) record|||mmHg||Standard Deviation|Mean
1375807|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
1375808|NCT01499810|Primary|Number of Serious Adverse Events|A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.|from baseline to 12 months||||Events|||Number
1375809|NCT01499810|Primary|Change in Office Systolic BP||from baseline to 12 months|All patients who completed 12 month assessment according to the protocol.|||mmHg||Standard Deviation|Mean
1375810|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod|||participants|||Number
1375811|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod|||participants|||Number
1375812|NCT01499667|Secondary|Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion|Gadolinium-enhancing lesions will be measured on post-contrast T1-weighted brain MRI scans|8 weeks and 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.|||Number of Gd enhanced T1 Lesions||Standard Deviation|Mean
1389426|NCT01362608|Secondary|Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment|Kaplan Meier estimate|12 weeks|Full analysis set|||hours||95% Confidence Interval|Median
1375813|NCT01499667|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group|Kurtzke’s Expanded Disability Status Scale (EDSS) measures the changes in neurologic impairment, either chronic (progression over time), or acute (MS relapses). The EDSS steps range from 0 (normal) to 10 (death due to MS). Relapse severity is assessed based on severity of neurologic impairment as evaluated using the EDSS.|Baseline to week 16 and week 32|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.|||Units on a scale||Standard Deviation|Mean
1375814|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline)|Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated for 24 weeks from baseline.|Baseline up to 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization|||Count of Active T2 Lesions||Standard Deviation|Mean
1375815|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated for first 8 weeks of fingolimod treatment.|Number of active T2 lesions during 8 wks of fingolimod treatment|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization|||Count of Active T2 Lesions||Standard Deviation|Mean
1375816|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated from baseline to beginning of treatment.|8, 12 and 16 weeks (number of active T2 lesions during the washout period only)|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization|||Count of active T2 lesions||Standard Deviation|Mean
1375817|NCT01499667|Primary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment|Active lesions were measured on brain MRI scans, performed at week 8, compared to the prior scan. The primary variable was analyzed by fitting a negative binomial regression model adjusted for washout group.|Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment|The modified Full Analysis Set (mFAS) included all patients in the Full Analysis Set who completed 8 weeks of fingolimod treatment and provided an MRI scan at this time point. The analysis of primary variable was performed on the mFAS.|||Count of Active T2 Lesions||Standard Deviation|Mean
1375818|NCT01499654|Post-Hoc|Injection and Scan Times|Time in minutes between doses of resting Tc-99m sestamibi doses and image scanning.|Baseline||||minutes||Standard Deviation|Mean
1375819|NCT01499654|Post-Hoc|Resting Full-Tracer Dose|Amount of the standard, clinically-accepted, full-dose Tc-99m sestamibi dose administered|Baseline|Entire Cohort|||millicurie||Standard Deviation|Mean
1375820|NCT01499654|Primary|Segments With Resting Perfusion Defect|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect.|Baseline||||segments||Standard Deviation|Mean
1375821|NCT01499654|Secondary|Diagnostic Confidence Score|Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline||||units on a scale||Standard Deviation|Mean
1375822|NCT01499654|Secondary|Image Quality Score|Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline||||units on a scale||Standard Deviation|Mean
1375823|NCT01499654|Primary|Sum Rest Score|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.|Baseline||||units on a scale||Standard Deviation|Mean
1375824|NCT01499576|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.|up to 1week after the acetic acid chromoendoscopy||||participants|||Number
1375825|NCT01499576|Secondary|Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists|"The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.~We calculate the Kappa index of agreement for the acetic acid chromoendoscopy."|One month after the completion of the study||||Kappa index of agreement|Participants||Number
1375826|NCT01499576|Primary|Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy|Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.|3 months after the completion of the study (a pathologist reviewed all the biopsy slide)||||percentage of lesions|Participants||Number
1375827|NCT01499498|Secondary|Number of Patients With Adverse Events|The number of repeated adverse events will be used to assess the safety of the drugs in combination|Day 1 - 16||||participants|||Number
1375828|NCT01499498|Primary|Boceprevir Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16||||ng/mL||95% Confidence Interval|Geometric Mean
1375829|NCT01499498|Primary|Sildenafil Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16||||ng/mL||95% Confidence Interval|Geometric Mean
1375830|NCT01499498|Primary|Boceprevir Alone Maximum Plasma Concentration|Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)|day 10-15||||ng/mL||95% Confidence Interval|Geometric Mean
1375831|NCT01499498|Primary|Sildenafil Alone Maximum Plasma Concentration|Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 1||||ng/mL||95% Confidence Interval|Geometric Mean
1375832|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study|Number of days between first visit with response to last consecutive visit with partial or complete response. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|up to Week 52|The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).|||days||Standard Deviation|Mean
1375833|NCT01499355|Secondary|Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period|AEs that had an onset on or after dosing of BIIB023 or placebo, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Week 12 to Week 56|The safety population was defined as all subjects who received at least 1 dose of study treatment (including placebo or BIIB023).|||participants|||Number
1375834|NCT01499355|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period|AEs that had an onset on or after dosing of MMF on run-in Day 1 up to the first double-blind dose, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Day 1 to Week 12|All enrolled participants|||participants|||Number
1375835|NCT01499355|Secondary|Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52|Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): > 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and > 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory, and presence of cellular casts (RBC or WBC). Inactive urinary sediment is defined as: < 5 RBC/HPF and < 5 WBC/HPF, or within the laboratory reference range, and no cellular casts (no RBC or WBC casts).|Baseline, Week 52|Participants with active urinary sediment at Day 1 in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants||90% Confidence Interval|Number
1375836|NCT01499355|Secondary|Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52||Baseline (Day 1), Week 52|Participants with a uPCR > 3.0 mg/mg at Baseline in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes those who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants||90% Confidence Interval|Number
1375837|NCT01499355|Secondary|Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52|Onset of renal response was calculated as weeks elapsed from baseline date to first visit where renal response was achieved. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|Baseline to Week 52|Participants in the ITT population who achieved a renal response at Week 52. The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).|||weeks||Full Range|Median
1376216|NCT01495858|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1375838|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52|Duration of response was calculated as the days in between the date of Week 52 visit and the date when the participant last became complete renal responder on or before Week 52 visit. Complete renal response: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||Participants|||Count of Participants
1375839|NCT01499355|Secondary|Percentage of Participants Who Achieve Complete Renal Response at Week 52|Complete renal response is defined as uPCR < 0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants|||Number
1375840|NCT01499355|Primary|Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52|Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) < 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range).|Week 52|Participants in the modified intent-to-treat (mITT) population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants||90% Confidence Interval|Number
1375841|NCT01499303|Primary|Objective Response Rate|Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis.|Week 8|Full analysis set - all randomised patients|||Patients||95% Confidence Interval|Number
1375842|NCT01499290|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug|PK analysis set|||(NG/ML)||Full Range|Geometric Mean
1375843|NCT01499290|Secondary|Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day.|Test of Cure: 1 to 14 days after start of study drug|Clinically evaluable (CE) with fever, defined as >38ºC at study entry.|||Participants|||Number
1375844|NCT01499290|Secondary|Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|Microbiological responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
1375845|NCT01499290|Secondary|Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
1375846|NCT01499290|Secondary|Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
1376043|NCT01497613|Secondary|Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .|Use the computer attitude scale to measure the level of computer comfort from baseline to 6th month follow-up. Higher score means more computer comfort. Range (5-25).|baseline and 6 months||||units in scale||Standard Deviation|Mean
1375847|NCT01499290|Secondary|Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug.|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
1375848|NCT01499290|Secondary|Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set|Microbiological responses as per the protocoled criteria: responses other than “indeterminate” were classified as “favorable” or “unfavorable.” Favorable microbiological response assessments included “eradication” and “presumed eradication.” Unfavorable microbiological response assessments included “persistence,” “persistence with increasing minimum inhibitory concentration (MIC),” and “presumed persistence.” Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to a surgical review panel (SRP) assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
1375849|NCT01499290|Secondary|Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
1375850|NCT01499290|Secondary|Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|Extended ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, pathogen in the initial/prestudy culture, regardless of susceptibility.|||Participants|||Number
1375851|NCT01499290|Secondary|Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, susceptible pathogen in the initial/prestudy culture.|||Participants|||Number
1375852|NCT01499290|Primary|Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|The CE analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Participants|||Number
1375853|NCT01499290|Primary|Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|TOC: 28 to 35 days after start of study drug|The MITT analysis set included all randomized patients who met the disease definition of cIAI and who received any amount of study drug.|||Participants|||Number
1375854|NCT01499290|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
1375855|NCT01499277|Secondary|Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME|Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set|7 to 20 days after the last dose of study drug||||Participants|||Number
1375856|NCT01499277|Secondary|Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set|The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.|48 to 72 hours after first dose of study drug||||Participants|||Number
1375857|NCT01499277|Secondary|Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC|The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.|21 to 42 days after the last dose of study drug||||Participants|||Number
1375858|NCT01499277|Secondary|Clinical Response at EOT in CE Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or +1 day)||||Participants|||Number
1375859|NCT01499277|Secondary|Clinical Response at End of Treatment (EOT) in MITT Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or + 1 day)||||Participants|||Number
1375860|NCT01499277|Secondary|Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set|Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically evaluable (ME)|||Participant|||Number
1375861|NCT01499277|Secondary|Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set|Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically modified-intent-to-treat (mMITT)|||Participant|||Number
1375862|NCT01499277|Primary|Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Clinical evaluable (CE)|||Participant|||Number
1375863|NCT01499277|Primary|Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Modified intent-to-treat (MITT)|||Participant|||Number
1375864|NCT01499199|Secondary|Number of Participants With Treatment-emergent Genotypic and Phenotypic Resistance to DTG and Other Antiretroviral Therapy (ART)|The number of participants with treatment-emergent genotypic and phenotypic resistance to integrase inhibitors (INIs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transctiptase inhibitors (NNRTIs), and protease inhibitors (PIs) was assessed.|Baseline through the date the last participant completed Week 96|Protocol Defined Virologic Failure (PDVF) Genotypic Population (Integrase inhibitor [IN] Results at Baseline and PDVF): The PDVF Genotypic and Phenotypic populations consisted of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time of PDVF|||participants|||Number
1375865|NCT01499199|Secondary|The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Any abnormal laboratory test result (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., electrocardiograms [ECGs], radiological scans, vital sign measurements), including those that worsen from Baseline, and were felt to be clinically significant in the medical and scientific judgment of the investigator, were recorded as AEs or SAEs. Clinically suspected cases of hypersensitivity to ABC were also SAEs.|Baseline (BL) through the date the last participant completed Week (W) 96 + the follow-up visit (if applicable)|Safety Population: all participants who received at least one dose of study medication. Participants were analyzed according to the actual treatments received. Participants were not excluded from this population as a result of changes to the background regimen.|||participants|||Number
1375866|NCT01499199|Secondary|Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences|The number of participants who reported a new or recurrent Centers for Disease Control and Prevention (CDC) Class B or Class C condition was assessed from Baseline though the date the last participant completed Week 96 + the follow-up visit (if applicable). Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition.|Baseline through the date the last participant completed Week 96 + follow-up visit (if applicable)|ITT-E Population|||participants|||Number
1375880|NCT01499173|Other Pre-specified|Program Satisfaction|Program satisfaction is measured by percentage of participants that completed the program who answered on the post test: very satisfied or extremely satisfied on a questionnaire about the program.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop||||percentage of participants|||Number
1375867|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96|The absolute value for CD48+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 12, Week 16, Week 24, Week 48, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 12, 16, 24, 48, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.|||cells/mm^3||Full Range|Median
1375868|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.|||cells/mm^3||Full Range|Median
1375869|NCT01499199|Secondary|Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall|The Pearson Correlation Coefficient is a measure of the correlation between CSF DTG concentrations and absolute values/changes from Baseline in CSF HIV-1 RNA at Week 2 and Week 16. CSF HIV-1 RNA is measured as log10 copies per milliliter (copies/mL).|From Baseline to Week 16|CSF Pharmacodynamic Population. The overall analysis combines Week 2 and Week 16 data; thus, analysis was performed on 22 data points from 11 participants.|||Pearson Correlation Coefficient||90% Confidence Interval|Mean
1375870|NCT01499199|Secondary|Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16|The relationship between HIV-1 RNA suppression in plasma and the CSF was measured as a comparison and as a change in the number of participants in the cross tabulation of <50 copies/mL in plasma, <50 copies/mL in CSF, >=50 copies/mL in plasma, and >=50 copies/mL in CSF at Baseline, Week 2, and Week 16.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time point were assessed.|||participants|||Number
1375871|NCT01499199|Secondary|Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as absolute values and change from Baseline in HIV-1 RNA levels in CSF at Week 2 and Week 16. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time points were assessed.|||log10 c/mL||Full Range|Median
1375872|NCT01499199|Secondary|Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as the number of participants with HIV-1 RNA <50 copies/milliliter (c/mL).|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population: all participants who received DTG and underwent lumbar puncture during the study and provided CSF HIV-1 RNA data. Only those participants available at the indicated time points were assessed.|||participants|||Number
1375873|NCT01499199|Secondary|Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The plasma samples were collected at the Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96 visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.|||log10 copies/mL||Full Range|Median
1375874|NCT01499199|Secondary|Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16|HIV-1 RNA response in plasma was measured as the number of participants with HIV-1 RNA less than 50 c/mL at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16.|Baseline; Weeks 2, 4, 8, 12, and 16|Intent -to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of investigational product|||participants|||Number
1375875|NCT01499199|Primary|DTG Concentrations in CSF at Weeks 2 and Week 16|CSF is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma PK sampling. DTG concentration in CSF were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|CSF DTG Concentration Population: all participants receiving DTG who underwent lumbar puncture during the study and provided evaluable DTG CSF concentration data. One participant was excluded from the analysis at Week 2.|||Nanograms per milliliter (ng/mL)||Full Range|Median
1375876|NCT01499199|Primary|Plasma DTG Unbound Fraction at Week 2 and Week 16|The unbound fraction of DTG in plasma (presented as a percentage of unbound [i.e., free DTG not bound to cellular proteins] DTG plasma concentration over paired plasma total DTG concentration) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population|||Percentage||Full Range|Median
1375877|NCT01499199|Primary|Unbound DTG Plasma Concentrations at Week 2 and Week 16|Unbound (free, not bound to cellular proteins) plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population|||Nanograms per milliliter (ng/mL)||Full Range|Median
1375878|NCT01499199|Primary|Total DTG Plasma Concentrations at Week 2 and Week 16|Total plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population: all participants receiving DTG who underwent PK sampling during the study and provided evaluable DTG plasma concentration data|||Micrograms per milliliter (µg/mL)||Full Range|Median
1375879|NCT01499199|Primary|The Ratio of Total and Unbound DTG Concentrations Between Cerebrospinal Fluid (CSF) and Plasma at Week 2 and Week 16|Cerebrospinal fluid (CSF) is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma pharmacokinetic (PK) sampling. The ratio (presented as a percentage) of CSF DTG concentration over paired plasma total DTG concentration (RCSF_plasma) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma/CSF DTG Paired Sample Population: participants (par.) with plasma and CSF samples collected post-dose and within 1 hour of each other (one par. withdrew prior to Week 2 and did not contribute to PK assessments). One par. was excluded from the analysis at Week 2 because his/her paired samples were not collected within the specified timeframe.|||percentage||Full Range|Median
1375881|NCT01499173|Secondary|Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points|"Stroke attitude is measured by the odds ratio of participant’s positive perception of calling 911 for stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of stroke attitude change in the post-test compared to pre-test. Stroke attitude questioners were: Q1) If I were to see signs of a stroke, calling 911 would be... (range extremely pleasant to very unpleasant); and Q2) If a person has signs of a stroke, calling 911 right away could be... (range very helpful to very harmful). Given that participants within each church are more alike than participants between churches and multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test stroke attitude after accounting for the participants’ church."|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test||||Odds ratio|||Number
1375882|NCT01499173|Secondary|Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points|Perception of self-efficacy is measured by the odds ratios of the responses to questions of participant confidence in being able to identify and respond appropriately to a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of positive self-efficacy change in the post-test compared to the pretest. Questions asking about self-efficacy were:1) I would be able to tell if someone is having a stroke and 2) I know what to do if I saw someone having a stroke. Given that participants within each church are more alike than participants between churches and multiple time points hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed posttest self-efficacy after accounting for the participants’ church.|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test||||odds ratio|||Number
1375883|NCT01499173|Secondary|Perception of Social Norms Clustered Within Churches Across Multiple Time Points|Perception of social norms is measured by the odds ratio of the responses to questions of participant agreement with others' influence to calling 911 if he/she were to see a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of the positive change in social norms in the post-test compared to the pre-test. Questions: 1) Most people would call 911 if they were to see a stroke. 2) My family would want me to call 911 if I were to see a stroke. Given that participants within each church are more alike than participants between churches and the multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test social norms after accounting for the participants’ church.|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test||||odds ratio|||Number
1375884|NCT01499173|Secondary|Mean Change in Stroke Recognition|Stroke recognition was scored on a 0 - 9 point scale where 0 represents no correct answers regarding 9 scenarios and 9 represents perfect stroke recognition.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop||||units on a scale||95% Confidence Interval|Mean
1375885|NCT01499173|Secondary|Mean Change in Behavioral Intent to Call 911|The pre-test is conducted one week prior to the post-test. A higher score indicates greater behavioral intent. Behavioral intent is measured on a scale of 0 - 8, where 0 indicates no correct answers in responses to scenarios, and 8 indicates appropriate responses (calling 911 every time it is appropriate) to the scenarios presented.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop||||units on a scale||95% Confidence Interval|Mean
1375886|NCT01499173|Primary|Completion|Number of participants who complete the intervention|1 week|descriptive|||Participants|||Count of Participants
1375887|NCT01499160|Secondary|PROGRESSION FREE SURVIVAL TUMOR ASSESSMENT|Patients treated with the combination of Letrozole and Lapatinib will provide tumor biopsy sample|From date of study entry until 4 weeks after removal from study or until death (whichever occurs first) up to 24 months.|data analysis was not conducted due to low sample (low accrual) and study closure|||Participants|||Count of Participants
1375888|NCT01499160|Primary|Clinical Benefit Rate of Patients Treated With the Combination of Letrozole and Lapatinib and Then After Progression, Treated With Everolimus, Letrozole and Lapatinib.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.~Clinical benefit rate is defined as complete response+partial response+ stable disease. All participants will be treated with the combination of letrozole and lapatinib. Once the participant progresses on this regimen, the participant will be treated with everolimus, letrozole and lapatinib until they progress."|From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months|1 patient withdrew during cycle 1|||Participants|||Count of Participants
1375889|NCT01499147|Secondary|Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).|Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.|Up to 100 days post-transplant (acute GVHD).||||participants|||Number
1375890|NCT01499147|Secondary|Time to ANC and Platelet Engraftment|Days to engraftment|Up to 30 days post-transplant||||days to ANC and platelet engraftment||Full Range|Median
1375891|NCT01499147|Secondary|Participants With 100 Day Transplant-related Mortality.|Day 100 transplant-related mortality was measured in both groups.|Up to 100 days post-transplant.||||participants|||Number
1375892|NCT01499147|Primary|Number of Participants With Engraftment.|Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.|Up to 30 days post-transplant||||participants|||Number
1376243|NCT01495585|Primary|Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.||28 days||||log(IU/ml)||Standard Deviation|Mean
1375893|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Stairs Score|Change in stairs score as captured by the Walking Impairment Questionnaire (WIQ) stairs subscale. This scale item asks the subject to describe the degree of difficulty climbing one, two, or three flights of stairs in the past week. A flight of stairs is defined as 14 steps. A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, 5) Unable to Do, or 6) Didn Do for Other Reasons. The items on the subscale are weighted according to the difficulty of the task. The stairs score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|"Four people in the nebivolol group and 1 person in the metoprolol group did not complete the items in the Stairs WIQ subscale therefore they were excluded from the analysis. One person in the metoprolol succinate group withdrew consent before the end of the study so they were also excluded from the final analysis."|||units on a scale||Standard Deviation|Mean
1375894|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Speed Score|Change in speed score as captured by the Walking Impairment Questionnaire (WIQ) speed score subscale. In the walking speed component, the degree of difficulty walking is ranked on a 0 to 4 scale where speed is assessed for each of the following speeds: at the following speeds: 1, slowly; 2, average speed; 3, quickly; or 4, running or jogging 1 block. Zero represents the inability to walk the specified speed, and 4 represents no difficulty. The items on the subscale are weighted according to the difficulty of the task. The speed score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group. One patient in the nebivolol group failed to complete the items in the WIQ speed score subscale, therefore, only 8 patients were included in the analysis for this outcome.|||units on a scale||Standard Deviation|Mean
1375895|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score|Change in distance score as captured by the Walking Impairment Questionnaire (WIQ) distance score subscale. The degree of difficulty in the walking of specific distances is ranked on a 0 to 4 Likert scale, in which 0 represents the inability to walk the distance and 4 represents no difficulty. A Likert scale is an ordinal scale of consecutive, equidistant, numerical values (ie, 0 to 4). The distances assessed in the WIQ range from walking indoors around the home to walking 5 blocks (1500 feet). The items on the subscale are weighted according to the difficulty of walking. The distance score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||units on a scale||Standard Deviation|Mean
1375896|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain|Change in buttock pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||units on a scale||Standard Deviation|Mean
1375897|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change Calf Pain|Change in calf pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||units on a scale||Standard Deviation|Mean
1375898|NCT01499134|Secondary|Claudication Onset Time (COT)|Change in measurement of claudication onset time (COT). The COT is defined as the time when a patient first experienced pain walking during a treadmill test.|Baseline COT is measured at the time of enrollment and again at the final study visit at 26 weeks.|Final measurements of COT in the metoprolol succinate group excludes one subject who did not experience claudication while walking during the treadmill test, and one subject who withdrew consent prior to the end of the study, therefore, only 6 participants are included in the analysis for this group.|||seconds||Standard Deviation|Mean
1375899|NCT01499134|Secondary|Ankle-brachial Index (ABI)|Change in measurement of Ankle-brachial index (ABI). The ABI is the ratio of the blood pressure measured in the lower legs to the blood pressure measured in the arms.|Baseline ABI is measured at the time of enrollment and again at the final study visit at 26 weeks|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||Ankle-Brachial Index||Standard Deviation|Mean
1375900|NCT01499134|Primary|Peak Walking Time (PWT)|Change in peak walking time (PWT) is measured in seconds. The PWT is defined as when walking on a treadmill cannot continue due to maximal leg pain, resulting in the discontinuation of the treadmill test.|Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||seconds||Standard Deviation|Mean
1375960|NCT01498692|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1376044|NCT01497613|Primary|Change Overall Well-being Measured by SF-36 Overall Well-being Subscale|Use the SF-36 to measure the overall well-being from baseline to 12th month follow-up. Higher score means more peaceful, happy and calm. Range (0-100).|Baseline and 12th month||||units in scale||Standard Deviation|Mean
1375901|NCT01499095|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6 up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants who were receiving HOE901­U300 (Adaptable dosing intervals or Fixed dosing intervals). Missing data imputed using last observation carried forward.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1375902|NCT01499095|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
1375903|NCT01499095|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper­ and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4­8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1375904|NCT01499095|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.|||U/kg||Standard Error|Least Squares Mean
1375905|NCT01499095|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time­point of 8­point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Only participants from the mITT population with a value at baseline and at the specified timepoint were analyzed (represented by n=X, X in the category titles). Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
1375906|NCT01499095|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
1375907|NCT01499095|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
1375908|NCT01499095|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
1375909|NCT01499095|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.|||percentage of mean||Standard Error|Least Squares Mean
1375910|NCT01499095|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.|||mmol/L||Standard Error|Least Squares Mean
1376045|NCT01497613|Primary|Change in Level of Social Support Measured by Social Support Scale|Measures the level of social support from baseline to 12th month follow-up. Higher score means more social support. Range (6-36).|Baseline and 12th month||||units on a scale||Standard Deviation|Mean
1376046|NCT01497613|Primary|Change in Social Isolation Measured by Friendship Scale|Measures the level of social isolation from baseline to 12th month follow-up. Lower score means less social isolation. Range (0-24) .|Baseline and 12th month||||units on a scale||Standard Deviation|Mean
1375911|NCT01499095|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis.|Week 9 Up to Month 6|Modified intent­to­treat population.|||percentage of participants|||Number
1375912|NCT01499095|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1375913|NCT01499082|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.|Month 6 Up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants enrolled in the substudy and who were receiving HOE901-U300 (Adaptable dosing intervals or Fixed dosing intervals).|||percentage of hemoglobin||Standard Error|Least Squares Mean
1375914|NCT01499082|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
1375915|NCT01499082|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
1375916|NCT01499082|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.|||U/kg||Standard Error|Least Squares Mean
1375917|NCT01499082|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point. Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
1375918|NCT01499082|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
1375919|NCT01499082|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
1375920|NCT01499082|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
1375921|NCT01499082|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.|||percentage of mean||Standard Error|Least Squares Mean
1375922|NCT01499082|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.|||mmol/L||Standard Error|Least Squares Mean
1375923|NCT01499082|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).|Week 9 Up to Month 6|Modified intent-to-treat population.|||percentage of participants|||Number
1375924|NCT01499082|Primary|Change in HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1375925|NCT01498978|Secondary|Correlation Between IRAE and Overall Survival.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
1375926|NCT01498978|Secondary|Correlation Between IRAE and Any Progression.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
1375927|NCT01498978|Secondary|Correlation Between IRAE and Radiographic Progression.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event. Radiographic progression is progression determined by scan.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
1375928|NCT01498978|Secondary|Correlation Between IRAEs and Immune Response|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis.~No data displayed because Outcome Measure has zero total participants analyzed."|Up to day 1 of course 4|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive||||||
1375929|NCT01498978|Secondary|Correlation of IRAEs With Ratio of T Regulatory Cells to T Effector Cells|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~Raw T cells data was collected, but has not been analyzed by the lab and will not be done due to constraints.~No data displayed because Outcome Measure has zero total participants analyzed."|Up to day 1 of course 4|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive||||||
1375930|NCT01498978|Secondary|Correlation Between IRAE and PSA Progression.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event. PSA (prostate-specific antigen) Progression is defined as a PSA increase of >= 25% and at least 2 ng/mL from Baseline, or Nadir PSA Achieved, confirmed by a second measurement at least three weeks later.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
1375931|NCT01498978|Secondary|Number of Patients With IRAEs|"Immune-Related Adverse Events (IRAEs) are defined as an adverse event (AE) of unknown etiology associated with drug exposure and consistent with an immune phenomenon~Tabulated for each treatment group and summarized according to major organ categories of the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0."|Up to 6 months|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
1375932|NCT01498978|Secondary|Time to Death From Any Cause|"Time to death is calculated from Day 1 of combination therapy to death from any cause.~Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||days||95% Confidence Interval|Median
1375933|NCT01498978|Secondary|Time to Progression by Any Measure|"Time to progression is calculated from Day 1 of combination therapy to first evidence of progression by any measure (PSA, Measurable Disease or Clinical Progression).~Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||days||95% Confidence Interval|Median
1376244|NCT01495572|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|10 months||||participants|||Number
1375934|NCT01498978|Secondary|Time to PSA Progression|"PSA (prostate-specific antigen) progression defined as a PSA increase of >= 25% and at least 2 ng/mL from baseline or nadir PSA achieved, confirmed by a second measurement at least three weeks later~Time to PSA progression is calculated as the time from Day 1 of combination therapy to first PSA measurement of >= 25% increase and at least 2 ng/mL above the nadir and confirmed by a second measurement at least three weeks later. For subjects without a PSA decline from baseline, time to PSA progression is calculated as the time from Day 1 of combination therapy to first PSA measurement of >= 25% increase and at least 2 ng/mL increase from baseline after 12 weeks and confirmed by a second measurement at least three weeks later.~Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||days||95% Confidence Interval|Median
1375935|NCT01498978|Primary|Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml)|"Undetectable PSA (prostate-specific antigen) defined as PSA ≤ 0.2 ng/mg after initiation of ipilimumab therapy.~Provided with the exact 95% confidence interval. PSA response as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG2) definitions.~Percentage can take on values between 0% and 100%."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||percentage of patients||95% Confidence Interval|Number
1375936|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period|48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."|||percentage of subjects|||Number
1375937|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time|24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."|||percentage of subjects|||Number
1375938|NCT01498822|Secondary|Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period||From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."|||months||Full Range|Median
1375939|NCT01498822|Primary|Percentage of Subjects With a Treatment Failure|Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.|Week 0 (First Dose) to Week 50|Per Protocol Set (PPS) consisted of all subjects who received at least 1 (partial) dose of study mediaction, returned at least 1 post-Baseline seizure diary and had no important protocol deviations. Subjects who discontinued the study before Week 50 for any reason other than treatment failure were excluded from the PPS.|||percentage of subjects|||Number
1375940|NCT01498744|Secondary|Complication to Antibiotic Regime||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.|||participants|||Number
1375941|NCT01498744|Secondary|Additional Skin or Soft Tissue Infections in Household Contacts||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.|||participants|||Number
1375942|NCT01498744|Secondary|Additional Skin and Soft Tissue Infections in Patient|The outcome measure was reported by responding to a yes/no|Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included here.|||participants|||Number
1375943|NCT01498744|Primary|Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.||At office visit 10-14 days post operation|Only participants that had data collected for this outcome measure are included above.|||participants|||Number
1375944|NCT01498692|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death.|Duration of Hospital Stay (average 1-2 days)|Analysis was intention to treat|||percentage of participants|||Number
1375945|NCT01498692|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|During the index procedure (minutes)|Analysis was intention to treat|||percentage of stents|stents||Number
1375946|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with ST|||Number
1376047|NCT01497613|Primary|Change Overall Well-being Measured by SF-36 Overall Well-being Subscale|Use the SF-36 scale to measure the overall well-being from baseline to 6th month follow-up. Higher score indicates more peaceful, happy, and calm. Range (0-100)|Baseline and 6th month||||units in scale||Standard Deviation|Mean
1375947|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with ST|||Number
1375948|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC)Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with ST|||Number
1375949|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TVR|||Number
1375950|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TVR|||Number
1375951|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TVR|||Number
1375952|NCT01498692|Secondary|Target Lesion Revascularization TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TLR|||Number
1375953|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TLR|||Number
1375954|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TLR|||Number
1375955|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375956|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375957|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375958|NCT01498692|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375959|NCT01498692|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375961|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with MI|||Number
1375962|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with MI|||Number
1375963|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with MI|||Number
1375964|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375965|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375966|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375967|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375968|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1375969|NCT01498692|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.|12 Months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.|||percentage of participants|||Number
1375970|NCT01498679|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
1376048|NCT01497613|Primary|Change in Level of Social Support Measured by Social Support Scale|Measures the level of social support from baseline to 6th month follow-up. Higher score means more social support. Range (6-36).|Baseline and 6th month||||units on a scale||Standard Deviation|Mean
1375971|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily diary by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1375972|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1375973|NCT01498679|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. A Repeated Measures analysis adjusted for Baseline, region, sex, age, treatment, week, week by Baseline interaction, and week by treatment interaction was used.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. Only those participants who had AM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization and were available at the indicated time point were assessed.|||L/min||Standard Error|Least Squares Mean
1375974|NCT01498679|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1375975|NCT01498653|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
1375976|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had symptom-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1375988|NCT01498588|Primary|Pathologic Complete Response Rate at the Time of Surgery|Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist’s standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR.|Average of 24 weeks|Pathology information at the time of definitive resection was available for six of seven patients. One patient was ultimately lost to follow-up.|||participants|||Number
1376049|NCT01497613|Primary|Change in Social Isolation Measured by Friendship Scale|Measures the level of social isolation from baseline to 6th month follow-up. Lower score means less social isolation. Range (0-24) .|Baseline and 6th month||||units on a scale||Standard Deviation|Mean
1375977|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had rescue-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1375978|NCT01498653|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had PM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.|||L/min||Standard Error|Least Squares Mean
1375979|NCT01498653|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1375980|NCT01498640|Secondary|Recurrence of Contracture|Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.|Day 365|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed|||joints|Joints||Number
1375981|NCT01498640|Secondary|Subject Global Assessment of Satisfaction|Subject global assessment of overall treatment satisfaction|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||participants|||Number
1375982|NCT01498640|Secondary|Physician Global Assessment of Improvement|Physician global assessment of change (improvement) in subject's Dupuytren's contracture|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||participants|||Number
1375983|NCT01498640|Primary|Change in Range of Motion|Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||degrees||Standard Deviation|Mean
1375984|NCT01498640|Primary|Percent Change From Baseline in Degree of Contracture|Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||percentage of contracture change||Standard Deviation|Mean
1375985|NCT01498640|Primary|Clinical Success|Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500|30 days after last injection|Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||percentage of particpants||95% Confidence Interval|Number
1375986|NCT01498601|Primary|Hospital Acquired Pneumonia Occurrences|Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.|10 months||||participants|||Number
1375987|NCT01498588|Secondary|Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events)|Toxicity of chemotherapy at each physician visit using Common Toxicity Criteria for Adverse Effects (CTCAE) criteria.|Through 20 weeks of chemotherapy||||participants|||Number
1376040|NCT01497613|Secondary|Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .|Use the computer attitude scale to measure the level of computer comfort from baseline to 12th month follow-up. Higher score means more computer comfort. Range (5-25)|baseline and 12 months||||units in scale||Standard Deviation|Mean
1376637|NCT01490931|Primary|Comparison of Pain Intensity Scores at 60 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period|VAS pain intensity score 60 minutes after dosing.|60 minutes post dose||||millimeters||Standard Error|Mean
1375989|NCT01498575|Primary|Late Driving Performance in On-road Assessment (ODA) Test|The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.|24 weeks after enrollment|512 teen-parent dyads were eligible and agreed to participate. Of these, 217 teens were scheduled to complete the ODA (128 were randomized to Teen Driving Plan (TDP), 89 to Usual Practice). Participant attrition over the time of the study resulted in 151 teens (86 TDP and 65 control) completing the 24-week ODA.|||Participants|||Number
1375990|NCT01498549|Primary|Rapid Visual Information Processing: Mean Correct Response Latency|Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A’) and response bias (B”) and response latency to targets.|2 years|Participants that completed any arm in the crossover are included in the analysis, participants with valid observations at both indices are included in the calculation.|||milliseconds||Standard Deviation|Mean
1375991|NCT01498549|Primary|Rapid Visual Information Processing|Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A’) and response bias (B”) and response latency to targets.|2 years|Participants that completed any arm in the crossover are included in the analysis.|||Proportion of Participants||Standard Deviation|Mean
1375992|NCT01498458|Secondary|Clinical Benefit Rate (CBR)|To determine the clinical benefit rate (CBR) in patients with measurable disease. CBR consists of complete response , partial response, and stable disease lasting greater than 24 weeks. All patients are included when determining this rate. 2 patients were on study treatment for a long time.Hence the outcome rate of 25 percent ( 2 from 8 patients)|3 years|All patients are included when determining this rate.|||percentage of participants|||Number
1375993|NCT01498458|Secondary|Objective Response Rate (ORR)|To determine the objective response rate (ORR) in patients with measurable disease. ORR consists of complete response and partial response according to the RECIST criteria. Complete Response refers to the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to less than 10 mm. Partial Response refers to an at least 30 percent decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|3 years|All patients are included when determining this rate.|||percentage of participants|||Number
1375994|NCT01498458|Secondary|Other Toxicity of the Combination of Pazopanib and Capecitabine||3 years|6 patients experience 6 Serious Adverse Reactions|||participants|||Number
1375995|NCT01498458|Secondary|Hematological Toxicity of the Combination of Pazopanib and Capecitabine||3 years||||Number of cycles|||Number
1375996|NCT01498458|Secondary|Dose-limiting Toxicity (DLT)||3 years||||participants|||Number
1375997|NCT01498458|Primary|Maximum Tolerable Dose (MTD) of Pazopanib|The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.|3 years||||mg|||Number
1375998|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. This was measured at visit 24(Day 57).|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.|||percentage of patients|||Number
1375999|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 206.|||days||Inter-Quartile Range|Median
1376000|NCT01498419|Secondary|Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm.||8 weeks|The Safety population was analyzed for this outcome.|||percentage of participants|||Number
1376001|NCT01498419|Secondary|The Rate of Change in Time to Sputum Culture Positivity (TTP) Through 8 Weeks in the MGIT System in Sputum Over 8 Weeks in Participants as Derived From a Non-linear Regression Model.|Measurement of TTP in liquid culture media Mycobacteria growth indicator tube (MGIT) using standard procedures|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 179.|||log10hours/day||95% Confidence Interval|Mean
1376041|NCT01497613|Secondary|Change in Technology Adoption Measured by Technology Acceptance Questionnaire|Measure the level of technology adoption from baseline to 6th month follow-up. Higher score means more acceptance. Range (6-42)|baseline and 6 months|Some participants did not complete the questionnaire|||units on a scale||Standard Deviation|Mean
1376638|NCT01490931|Primary|Comparison of Pain Intensity Scores at 40 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|VAS pain intensity score at 40 minutes post-dose|40 minutes post dose||||millimeters||Standard Error|Mean
1376002|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. (Day 57)|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.|||percentage of participants|||Number
1376003|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media|liquid culture = Mycobacteria growth indicator tube (MGIT) Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants included for this outcome was 206.|||days||Inter-Quartile Range|Median
1376004|NCT01498419|Primary|The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment.|The primary efficacy endpoint was bactericidal activity characterized by the daily rate of change in mean log10CFU counts during 8 weeks of treatment (bactericidal activity assessed by CFU on solid media for days 0–56).|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 173.|||log10CFU/ml/day||95% Confidence Interval|Mean
1376005|NCT01498185|Secondary|Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. MR was calculated as the ratio of metabolite to parent AUC(TAU), corrected for molecular weights of dapagliflozin and dapagliflozin 3-O-glucuronide (408.82 and 584.99, respectively).|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||(ng*h/mL):(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1376006|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1376007|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||hour||Full Range|Mean
1376008|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1376009|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as “missing” for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1376010|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||hour||Full Range|Mean
1376011|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1376012|NCT01498185|Primary|Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7|7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.|From Baseline to Day 7|All randomized participants who received study medication and had nonmissing values at baseline and Day 7|||mg/dL||Standard Error|Mean
1376013|NCT01498120|Primary|Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.|||subjects|||Number
1376014|NCT01498120|Primary|Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.|||subjects|||Number
1376015|NCT01498068|Secondary|Number of Participants in Each Specific Category of Treatment Outcome|Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =>25 IU/mL during follow-up period after previous HCV RNA<25 IU/mL at planned end of treatment(EOT)[Week 24 or Week 48] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase >1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA has previously become <25 IU/mL during treatment).Stopping rule defined as HCV RNA value >1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA <25 IU/mL at actual EOT and never HCV RNA =>25 IU/mL thereafter.|From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
1376016|NCT01498068|Secondary|Number of Participants With Virologic Failure|Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.|Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
1376017|NCT01498068|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48|The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.|Weeks 8, 12, 24, 32, 40 and 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."|||Participants|||Number
1376018|NCT01498068|Secondary|Number of Participants With Rapid Virologic Response (RVR) at Week 4|A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4|Week 4|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
1376019|NCT01498068|Secondary|Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Changes from baseline in log10 HCV RNA levels were calculated.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."|||Log 10 IU/mL||Full Range|Median
1376020|NCT01498068|Primary|Number of Participants With Extended Rapid Virologic Response (eRVR)|A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.|Week 4 and Week 12|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
1376042|NCT01497613|Secondary|Changes in Technology Proficiency Measured by Technology Proficiency Scale|Measures the level of technology proficiency from baseline to 6th month follow-up. Higher scores means more computer proficiency. Range (6-30)|baseline and 6 months||||units on a scale||Standard Deviation|Mean
1376021|NCT01497938|Primary|The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)|An event is identified as: LGS feature in the correct setting; CGM values <= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was <= 65 mg/dL; The rate of change before reaching sensor glucose value of <= 65 mg/dL was <= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value <= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data.|5 months||||mg/dL x min||Standard Deviation|Mean
1376022|NCT01497938|Primary|Change in A1C From Baseline to End of Study Participation|The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.|5 months||||Percent||Standard Deviation|Mean
1376023|NCT01497899|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in Full Analysis Set with available data were analyzed.|||cells/uL||Standard Deviation|Mean
1376024|NCT01497899|Secondary|Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1376025|NCT01497899|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
1376026|NCT01497899|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants randomized to the Double-Blind Phase and received at least 1 dose of study drug.|||percentage of participants|||Number
1376027|NCT01497756|Secondary|Side Effects|Any recorded complications|Eight months|All patients|||participants|||Number
1376028|NCT01497756|Primary|Usage|Number of patients on whom CAPP is used|Eight months|Entire number of participants|||participants|||Number
1376029|NCT01497665|Secondary|Six Month Overall Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further survival data was collected and there was insufficient number of participants with data collected for this outcome measure.||||||
1376030|NCT01497665|Secondary|Duration of Overall Progression Free Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further efficacy data was collected and there was insufficient number of participants with data collected for this outcome measure.||||||
1376031|NCT01497665|Secondary|Duration of Overall Objective Response||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further data on response was collected and there was insufficient number of participants with data collected for this outcome measure.||||||
1376032|NCT01497665|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability||Upon enrollment through end of study period (1 year after last patient is enrolled)||||participants|||Number
1376033|NCT01497665|Primary|Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis|Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), < 30% decrease but <20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), >= 20% (>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.|upon enrollment through end of study period (1 year after last patient is enrolled)||||participants|||Number
1376034|NCT01497613|Secondary|Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale|Use the computer attitude scale to measure the level of computer efficacy from baseline to 12th month follow-up. Higher score means more efficacy towards computer. Range (5-25)|Baseline and 12th month follow-up||||units in scale||Standard Deviation|Mean
1376035|NCT01497613|Secondary|Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale|Use the computer attitude scale to measure the level of computer efficacy from baseline to 12th month follow-up. Higher score means more efficacy towards computer. Range (5-25)|Baseline and 6th month follow-up||||units in scale||Standard Deviation|Mean
1376036|NCT01497613|Secondary|Change in Computer Interest Measured by Computer Attitude - Interest Subscale|Use the computer attitude scale to measure the level of computer interest from baseline to 12th month follow-up. Higher score means more interest towards computer. Range (5-25)|Baseline and 12th month follow-up||||units in scale||Standard Deviation|Mean
1376037|NCT01497613|Secondary|Change in Computer Interest Measured by Computer Attitude - Interest Subscale|Use the computer attitude scale to measure the level of computer interest from baseline to 6th month follow-up. Higher score means more interest towards computer. Range (5-25)|Baseline and 6th month follow-up||||units in scale||Standard Deviation|Mean
1376038|NCT01497613|Secondary|Change in Technology Adoption Measured by Technology Acceptance Questionnaire|Measures the level of technology adoption from baseline to 12th month follow-up. Higher score means more acceptance. Range (6-42)|baseline and 12 months|Some participants did not answer the questionnaire|||units on a scale||Standard Deviation|Mean
1376039|NCT01497613|Secondary|Changes in Technology Proficiency Measured by Technology Proficiency Scale|Measures the level of technology proficiency from baseline to 12th month follow-up. A higher score means more computer proficiency. Range (6-30)|baseline and 12 months||||units on a scale||Standard Deviation|Mean
1376050|NCT01497366|Secondary|Percentage of Participants With Viral Relapse Following Treatment|Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.|Up to Post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1376051|NCT01497366|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either~Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement~Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)"|Baseline up to Week 24|Full Analysis Set|||percentage of participants|||Number
1376052|NCT01497366|Secondary|Change From Baseline in HCV RNA||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1376053|NCT01497366|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 Weeks|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1376054|NCT01497366|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)|SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.|Post-treatment Week 24|Full Analysis Set|||percentage of participants|||Number
1376055|NCT01497366|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities||Up to 24 weeks plus 30 days following the last dose of study drug|Safety Analysis Set|||participants|||Number
1376056|NCT01497366|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.|Post-treatment Week 12|Full Analysis Set|||percentage of participants|||Number
1376057|NCT01497275|Secondary|Overall Survival at 5 Year|Number of participants who were alive at the 5 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|5 year|No analysis completed due to study being terminated prior to the 5 year time point.||||||
1376058|NCT01497275|Secondary|Overall Survival at 1 Year|Number of participants who were alive at the 1 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|1 year|1 subject did not reach the one year evaluation because the study was terminated.|||participants|||Number
1376059|NCT01497275|Secondary|Number of Participants With Progression Free Survival|Progression-free survival will be defined as time from on-study to disease progression or death, whichever comes first|6 months|Only 3 subjects provided evaluable data at the 6 month time point. 2 subjects did not reach this time-point so they were not assessed for progression|||participants|||Number
1376060|NCT01497275|Primary|Response Rate (Complete Response + Partial Response)|"Disease will be assessed every 3 months.~The Cheson criteria will be used to define response:~Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy.~Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features: a) they should be clearly measurable in at least two perpendicular measurements; b) they should be from as disparate regions of the body as possible; and c) they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved."|3 months|Only 3 subjects completed the drug regimen; 1 subject did not complete due to disease progression; 1 did not complete due to adverse event.|||participants|||Number
1376061|NCT01497262|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity|28 weeks|Safety set includes all patients who received at least one dose of study drug|||Participants|||Number
1376062|NCT01497262|Secondary|Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.|The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.|4 months|Safety set includes all patients who received at least one dose of study drug|||Percent of Participants|||Number
1376063|NCT01497197|Secondary|Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to 15-20 days post r-hCG administration|Safety population included all randomized subjects who received at least one dose of the trial treatment.|||subjects|||Number
1376064|NCT01497197|Secondary|Number of Subjects With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35–42.|35 to 42 days post r-hCG administration|MITT included all subjects randomized into trial who received at least 1 dose of Gonal-f® or Luveris®, and completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). ‘N’=signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.|||subjects|||Number
1376079|NCT01496807|Secondary|Overall Survival (OS)|OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.|Up to 54 Months|All evaluable participants|||months||95% Confidence Interval|Median
1390698|NCT01350232|Secondary|Correction of Hemoglobinopathy|To evaluate the extent of correction of hemoglobinopathy following this reduced intensity transplant.|100 days post infusion through 5 years post infusion|||||||
1376065|NCT01497197|Secondary|Number of Subjects With Biochemical Pregnancies|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.|35 to 42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||subjects|||Number
1376066|NCT01497197|Secondary|Cycle Cancellation Rate Prior to r-hCG|If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.|Up to 85 days|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||percentage of subjects|||Number
1376067|NCT01497197|Secondary|Total Pregnancy Rate and Clinical Pregnancy Rate|The subject was considered to have a positive pregnancy result if beta-hCG >10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15–20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35–42.|35-42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||percentage of subjects|||Number
1376068|NCT01497197|Secondary|Number of Fetal Sacs With Detectable Heart Beats|Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.|||Fetal sacs||Standard Deviation|Mean
1376069|NCT01497197|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35–42 post r-hCG to confirm clinical pregnancy.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.|||Fetal sacs||Standard Deviation|Mean
1376070|NCT01497197|Secondary|Implantation Rate|The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.|||fetal sacs/embryo transferred||Standard Deviation|Mean
1376071|NCT01497197|Secondary|Total Number of Stimulation Treatment Days|The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.|6 days post stimulation (Number of stimulation days+6 days)|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||days||Standard Deviation|Mean
1376072|NCT01497197|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)|Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.|Screening|Data was not analysed as per planned analysis due to frequent protocol violations/deviations, there was no subject eligible to be analyzed per protocol.||||||
1376073|NCT01497197|Primary|Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation|Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.|34-38 hours post r-hCG administration|Modified intention-to-treat (MITT) included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following recombinant human follicle stimulating hormone (r-hFSH) stimulation and r-hCG injection).|||oocytes||Standard Deviation|Mean
1376074|NCT01497171|Primary|Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.|Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.|12 months|No analysis was done due to early termination of the study.||||||
1376075|NCT01496846|Secondary|Anesthetic Success Rate of an IANB With Articaine|Success rate of an IANB with articaine using a conventional IANB technique|15 min after injection|"All enrolled participants (N=201) received an IANB with Articaine. Two participants were excluded from data analysis due to inadequate lip numbness (IANB was considered missed block); thus N=199 were analyzed for success rate."|||Participants|||Count of Participants
1376076|NCT01496846|Primary|Anesthetic Success Rate of Supplemental Infiltration Injection|Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia|5 min after injection||||Participants|||Count of Participants
1376077|NCT01496807|Other Pre-specified|Count of Participants Developing Positive Autoantibody Screen|"Number of participants who developed a positive result during treatment for one or more antibodies of a previously negative screen.~This study was not designed to statistically test the efficacy of treatment, and no inferential analyses will be performed. Investigators planned to look for evidence of serologic and clinical autoimmunity."|Up to 54 Months|All evaluable participants|||Participants|||Count of Participants
1376078|NCT01496807|Secondary|Treatment Related Adverse Events (AEs) - Grade 3 to 5|Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.|4 Years, 1 Month|All Participants|||Participants|||Count of Participants
1376080|NCT01496807|Secondary|Progression Free Survival (PFS)|Immune Related Progressive Disease (irPD): increase in tumor burden >25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.|Up to 54 Months|All evaluable participants|||months||95% Confidence Interval|Median
1376081|NCT01496807|Secondary|Number of Participants With Overall Response (OR)|Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden >50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.|Up to 54 Months|All evaluable participants|||Participants|||Count of Participants
1376082|NCT01496807|Primary|Maximum Tolerated Dose (MTD) of Ipilimumab|MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.|Up to 48 Months|All participants|||mg/kg|||Number
1376083|NCT01496807|Primary|Maximum Tolerated Dose (MTD) of Sylatron|MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).|Up to 48 Months|All participants|||μg/kg s|||Number
1376084|NCT01496469|Secondary|Change From Baseline in Serum Urate Levels at Week 6||Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1376085|NCT01496469|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean DBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1376086|NCT01496469|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1376087|NCT01496456|Secondary|Lesion Survival After 3 Years|Discrete time survival analysis of time to first lesion progression.|3 years|Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased.|||Lesions|Lesions||Number
1376088|NCT01496456|Secondary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories|Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).|Baseline through 3 years||||Lesions|Lesions||Number
1376089|NCT01496456|Primary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)|Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).|Baseline through 3 years|Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).|||Lesions|Lesions||Number
1376090|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT|The change between the AUC for glucagon at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||ng*hours/L||Standard Error|Least Squares Mean
1376091|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT|The change between the AUC for insulin/glucose ratio at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||pmol*hr/mmol||Standard Error|Least Squares Mean
1376092|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT|The change between the AUC for C-peptide at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||nmol*hours/L||Standard Error|Least Squares Mean
1376093|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT|The change between the AUC for insulin at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||pmol*hours/L||Standard Error|Least Squares Mean
1376861|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Event|Event includes prophylactic infusions of study product and infusions of study product for treatment of bleeding episodes (BEs).|Throughout study period (approximately 17 months)||||IU/kg||Standard Deviation|Mean
1376094|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT|The change between the AUC for glucose at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mmol*hours/L||Standard Error|Least Squares Mean
1376095|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)|The change between the glucose value collected at weeks 6 and 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mmol/L||Standard Error|Least Squares Mean
1376096|NCT01496430|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
1376097|NCT01496430|Secondary|Change From Baseline in HbA1c|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1376098|NCT01496430|Secondary|Time to First Glycemic Rescue|The time to the first instance of participants requiring glycemic rescue during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.|||Days||Inter-Quartile Range|Median
1376099|NCT01496430|Secondary|Percentage of Participants Requiring Rescue Glycemic Therapy|Percentage of participants requiring rescue glycemic therapy during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1376100|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376101|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376102|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376103|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376104|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376105|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376122|NCT01496313|Secondary|Duration of Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||Months||95% Confidence Interval|Median
1376106|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376107|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean systolic blood pressure measured week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376108|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376109|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
1376110|NCT01496430|Secondary|Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
1376111|NCT01496430|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1376112|NCT01496430|Primary|Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
1376113|NCT01496352|Secondary|Incidence of Surgical Site Infection|The incidence of probable or definite surgical site infection as determined by the Investigator.|Up to 30 Days After Surgery|As treated|||Participants|||Number
1376114|NCT01496352|Secondary|Antibiotic Resistance|Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery|Baseline up to Day 5|As Treated|||Participants|||Number
1376115|NCT01496352|Secondary|Renal Function|Changes in serum creatinine from surgery on Day 1 until 14 days after surgery|Baseline up to Day 14|As treated|||Participants|||Number
1376116|NCT01496352|Secondary|Maximal Plasma Concentration (Cmax)|Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48, 96 hours post-dose|All subjects receiving DFA-02 active gel|||mcg/mL||Standard Deviation|Mean
1376117|NCT01496352|Primary|Area Under Curve (AUC)|Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48 96 hours post-dose|All Subjects Receiving Active Drug|||mcg/h/mL||Standard Deviation|Mean
1376118|NCT01496352|Primary|Number of Patients With Adverse Events, Laboratory, Physical Examination Changes|Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.|Baseline up to Day 30|As Treated|||Participants|||Number
1376119|NCT01496313|Secondary|Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.||Week 3 to week 60 (maximum)|All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.|||ng/ml||Standard Deviation|Mean
1376120|NCT01496313|Secondary|Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||% change||Standard Deviation|Mean
1376121|NCT01496313|Secondary|Time to Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||Months||95% Confidence Interval|Median
1376123|NCT01496313|Secondary|Best Objective Response||Randomisation to week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||Participants|||Number
1376124|NCT01496313|Primary|Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator|ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1|Randomisation to week 60 (maximum)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR|||Proportion of participants||95% Confidence Interval|Number
1376125|NCT01496287|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post procedure|Only 62 of the initial 70 subjects achieved procedure success, and were present for 2 week follow-up assessment with Tula tube in situ, such that tube retention could be measured.|||ears|Participants||Number
1376126|NCT01496287|Secondary|Procedure Tolerability|"Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient’s score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.~Tolerability was defined as an average post-procedure pain score (of treated ears) <= 3"|Day 0 (day of procedure)||||participants|||Number
1376127|NCT01496287|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)||||participants|||Number
1376128|NCT01496287|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)|Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted.|||devices|Participants||Number
1376129|NCT01496287|Primary|Number of Participants With Procedural, Serious, and Device-Related Adverse Events|Adverse events which are procedural, serious, and device-related.|procedure up to 2 weeks post procedure||||participants|||Number
1376130|NCT01496274|Secondary|Annualized Spontaneous Bleeding Events Compared Between 7 Day Prophylactic and Extended Regimens|Median number of spontaneous bleeds per year per subject comparing 7-, 10- and 14- day prophylactic regimens.|During treatment, between median 240 and 386 days per subject.|Efficacy Population|||bleeds/year/subject||Inter-Quartile Range|Median
1376131|NCT01496274|Secondary|Investigator’s (or Surgeon’s) Overall Clinical Assessment of Hemostatic Efficacy for Surgical Prophylaxis, Based on a Four Point Ordinal Scale (Excellent, Good, Moderate, Poor/No Response)|Number of surgical events treated prophylactically with rIX-FP that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s (surgeon’s) overall assessment of hemostatic efficacy for surgical prophylaxis.|Up to 14 days after surgery|Surgical Population|||events|Participants||Number
1376132|NCT01496274|Secondary|Clearance of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||mL/hr||Standard Deviation|Mean
1376133|NCT01496274|Secondary|Area Under the Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUClast) of a single dose of rIX-FP. PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||IU*hr/dL||Standard Deviation|Mean
1376134|NCT01496274|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||hour||Standard Deviation|Mean
1376135|NCT01496274|Secondary|Incremental Recovery of rIX-FP|Pharmacokinetic (PK) data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1376136|NCT01496274|Secondary|rIX-FP Consumed Per Month While Maintaining Assigned Prophylactic Treatment Interval During Routine Prophylaxis.|Time frame: For Prophylaxis Arm 7-, 10- and 14-day regimens, median 269, 240 and 386 days respectively. For On-demand Arm, prophylaxis regimen, median 316 days.|Median 269, 240, 386 and 316 days, respectively (see Description)|Efficacy Population|||IU/kg/month||Standard Deviation|Mean
1376137|NCT01496274|Secondary|Investigator’s Overall Clinical Assessment of Hemostatic Efficacy for Treatment of Bleeding Episodes, Based on a Four Point Ordinal Scales (Excellent, Good, Moderate, Poor/No Response)|Number of bleeding episodes requiring treatment that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator’s clinical assessment of hemostatic efficacy, expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months|Efficacy Population|||percentage of bleeding episodes|Participants||Number
1376138|NCT01496274|Secondary|Proportion of Bleeding Episodes Requiring One or ≤ Two Injections of rIX-FP to Achieve Hemostasis|Number of injections required to achieve hemostasis expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months.|Efficacy Population|||percentage of bleeding episodes treated|Participants||Number
1376141|NCT01496274|Primary|Number of Subjects Developing Inhibitors Against Factor IX (FIX)|The number of participants developing inhibitors against factor IX (FIX) along with the 95% Clopper-Pearson confidence interval, are summarized for subjects with 50 or more exposure days (EDs) to rIX-FP, and for all participants in the study.|Up to 27.7 months (maximum)|Safety Population|||participants||95% Confidence Interval|Number
1376142|NCT01496274|Primary|Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized)|Subjects in the on-demand arm received on-demand dosing with rIX-FP for up to 26 weeks (on-demand regimen), and then received weekly prophylaxis with rIX-FP for the remainder of the study (prophylaxis regimen). The effectiveness of prophylaxis in comparison to on-demand therapy was investigated by comparing the same subject’s annualized spontaneous bleeding rate (AsBR) during the on-demand regimen and during the prophylaxis regimen.|Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.|This analysis includes only the participants assigned to the on-demand arm who received at least 1 dose of rIX-FP in the on-demand regimen and at least 1 dose of rIX-FP in the prophylaxis regimen.|||bleeds/year/subject||Inter-Quartile Range|Median
1376143|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|8 weeks||||units on a scale||Standard Deviation|Mean
1376144|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|Baseline||||units on a scale||Standard Deviation|Mean
1376145|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|8 weeks||||units on a scale||Standard Deviation|Mean
1376146|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|Baseline||||units on a scale||Standard Deviation|Mean
1376147|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|8 weeks||||units on a scale||Standard Deviation|Mean
1376148|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|Baseline||||units on a scale||Standard Deviation|Mean
1376149|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|8 weeks||||units on a scale||Standard Deviation|Mean
1376150|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|Baseline||||units on a scale||Standard Deviation|Mean
1376151|NCT01496183|Other Pre-specified|Laboratory Breakfast Intake|Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo|baseline and 2 week treatment|The Laboratory Breakfast Intake assessment was not performed at the start of the study but was initiated during the course of the study. Only 3 participants from the Placebo group and 6 participants from the Olanzapine group completed the Laboratory Breakfast Intake assessment.|||kcal||Standard Deviation|Mean
1376152|NCT01496183|Secondary|Physical Activity as Measured Using a Physical Activity Monitor|Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment.|baseline and 2 week treatment|Due to poor participant's compliance with the study requirements for physical activity data collection, the data from 4 participants from the olanzapine group could not be used for analysis purpose.|||counts per day||Standard Deviation|Mean
1376194|NCT01495923|Secondary|Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index|Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.|3 months after the start of treatment||||participants||Standard Deviation|Mean
1376153|NCT01496183|Secondary|HDL|High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo|baseline and 2 weeks treatment|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
1376154|NCT01496183|Secondary|LDL|Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo|baseline and 2 weeks treatment|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
1376155|NCT01496183|Secondary|Change From Baseline Total Cholesterol|Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo|baseline and 2 weeks treatment|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
1376156|NCT01496183|Secondary|Change From Baseline in Insulin|Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.|||µIU/ml||Standard Deviation|Mean
1376157|NCT01496183|Secondary|Change From Baseline in Leptin|Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.|||ng/ml||Standard Deviation|Mean
1376158|NCT01496183|Secondary|Change From Baseline in Glucose|Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.|||mg/dl||Standard Deviation|Mean
1376159|NCT01496183|Secondary|Change From Baseline Triglycerides|Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
1376160|NCT01496183|Secondary|Change From Baseline in Resting Metabolic Rate|Resting metabolic rate at baseline and after 2 weeks of treatment|baseline and 2weeks of treatment||||kcal/24 hours||Standard Deviation|Mean
1376161|NCT01496183|Secondary|Change From Baseline in 24-Hour Dietary Recall|24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)||||kcal/day||Standard Deviation|Mean
1376162|NCT01496183|Secondary|Change From Baseline in Body Composition|lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo|baseline and 2 weeks of treatment (olanzapine or placebo)|The Body Composition assessment was not implemented at the start of the study but once the study already started. Therefore, not all study participants who completed the study got the Body Composition assessment done. Only 3 participants in the Placebo Group and 6 participants in the Olanzapine Group got the Body Composition assessment done.|||kg||Standard Deviation|Mean
1376163|NCT01496183|Primary|Change From Baseline in Weight||Assessed at baseline and 2 weeks||||Kg||Standard Deviation|Mean
1376164|NCT01496157|Secondary|PET Detection of Metastatic Disease at Initial Staging|To compare the detection of bone and nodal metastatic disease by DCFBC PET at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and biopsy pathology.|24 months|Data was not collected for this outcome measure.||||||
1376165|NCT01496157|Primary|PET Detection of Primary Prostate Cancer|To compare number of participants with positive or negative uptake of 18F-DCFBC in primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score > 4+3=7).|24 months||||Participants|||Count of Participants
1376166|NCT01496131|Secondary|Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT)|Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1).|Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)|"Analysis population included only the subjects who were randomized and provided consent for biopsy and whose baseline measurement was considered as evaluable. Here, number analyzed signifies subjects evaluable at specified time point and number analyzed=0 signifies that no subjects were evaluable at the specified time point."|||Participants|||Count of Participants
1376195|NCT01495923|Secondary|Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index|Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.|1 month after the start of treatment||||units on a scale||Standard Deviation|Mean
1376862|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Year (Annualized)||Throughout study period (approximately 17 months)||||IU/kg per year||Standard Deviation|Mean
1376167|NCT01496131|Secondary|Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels|"Progression/recurrence status was reported based on Prostate-specific Antigen (PSA) Levels. Recurrence of PSA after completion of therapy represents disease progression and was determined using the American Society for Therapeutic Radiology and Oncology (ASTRO) “Phoenix criteria. These criteria define biochemical recurrence after radiation therapy as a PSA level equal to the lowest (nadir) PSA level achieved after therapy plus 2 nanogram per milliliter."|From randomization up to 24 months|Analysis population included all subjects randomized in the study.|||Participants|||Count of Participants
1376168|NCT01496131|Primary|Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)|MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).|Baseline and Day 190 (Post-radiation)|"Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, Number of Participants Analyzed signifies subjects evaluable for this outcome measure."|||Participants|||Count of Participants
1376169|NCT01496131|Primary|Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)|MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).|Baseline and Day 60 (Pre-Radiation)|"Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, Number of Participants Analyzed signifies subjects evaluable for this outcome measure."|||Participants|||Count of Participants
1376170|NCT01496066|Secondary|Mean BSCVA|Mean BSCVA for the “best case” cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta).|6 months|ITT population best case cohort with no macular problems|||LogMAR||Standard Deviation|Mean
1376171|NCT01496066|Secondary|Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively|For eyes with <0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.|6 months|Participants with eyes in ITT with <0.75 D of cylinder prior to light treatment|||percent absolute reduction in MRSE||Standard Deviation|Mean
1376172|NCT01496066|Secondary|Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)|Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group.|6 months|Participants with eyes in ITT with >1.25 D of cylinder prior to light treatment|||percent reduction in cylinder||Standard Deviation|Mean
1376173|NCT01496066|Secondary|Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)|Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.|6 months|Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment|||percent reduction in cylinder||Standard Deviation|Mean
1376174|NCT01496066|Secondary|Uncorrected Visual Acuity 20/20 or Better|Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.|6 months|ITT|||percentage of eyes|||Number
1376175|NCT01496066|Primary|Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop|Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.|6 months|ITT: The overall number of participants analyzed differs from the other outcome measures because some photographs were unusable due to inadequate lighting, user error, or equipment failure.|||percentage of eyes||95% Confidence Interval|Number
1376176|NCT01496066|Primary|Percent Absolute Reduction in MRSE|Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.|6 months|ITT. Any eyes that had an MRSE of zero at Pre-Adjustment were excluded since it is not possible to divide by zero. Therefore the number participants analyzed for this outcome will differ from the number of overall participants in the study.|||percentage of reduction in MRSE||95% Confidence Interval|Mean
1376215|NCT01495858|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376177|NCT01496066|Primary|Percent Reduction in Manifest Cylinder|Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.|6 months|ITT. Only eyes that had cylinder in the range of treatment (>=0.75 D) were included in the analysis. Therefore the number of participants analyzed for this outcome measure will not match the overall number of participants in the study.|||percent reduction in manifest cylinder||95% Confidence Interval|Mean
1376178|NCT01495988|Secondary|Correlate Blood Markers of B-RAFV600 Mutation With Treatment Efficacy|Assess the effectiveness of blood reverse transcription polymerase chain reaction (RT-PCR) assay for BRAFV600 as a surrogate biomarker for tumor response and resistance in patients receiving vemurafenib/cobimetinib +/- bevacizumab.|Upon completion of the protocol (3 years)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
1376179|NCT01495988|Secondary|Effects of the Addition of Bevacizumab on Tumor Angiogenesis, Resistance Mechanisms and Immune Function|Perform a variety of correlative studies aimed at understanding the effects of vemurafenib/cobimetinib, and bevacizumab administration relative to vemurafenib/cobimetinib on tumor angiogenesis, resistance mechanisms and immune function.|Upon completion of the protocol (3 years)|The trial was terminated prematurely and outcome measures were not analyzed.||||||
1376180|NCT01495988|Secondary|Toxicity and Safety Profile|Describe the toxicity and safety profile of treatment with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab in patients with stage IV, BRAFV600E/K melanoma.|Until study completion|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
1376181|NCT01495988|Secondary|Response Rates|Compare response rate (RR) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|From time of randomization to time of disease progression (restaging for tumor response to occur every 8 wks until wk 48, then every 12 wks thereafter)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
1376182|NCT01495988|Secondary|Overall Survival|Compare overall survival (OS) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|Time between randomization and death due to any cause (overall survival rates also to be assessed at 12 and 18 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
1376183|NCT01495988|Primary|Median Progression-free Survival|To compare median progression-free survival (PFS) of patients with stage IV, BRAFV600E or BRAFV600K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|Time between randomization and disease progression (~10-15 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
1376184|NCT01495988|Primary|Maximum Tolerated Dose|To establish the maximum tolerated dose (MTD) of bevacizumab in combination with vemurafenib and cobimetinib.|Until MTD determined (up to 6 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed. MTD could not be determined.||||||
1376185|NCT01495975|Secondary|Unplanned Readmission or ED Visit|Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.|1 month after discharge|||||||
1376186|NCT01495975|Secondary|Diabetes Self-Management||1 month from discharge|||||||
1376187|NCT01495975|Secondary|Diabetes Distress|Measured by the Problem Areas in Diabetes (PAID) Questionnaire|1 month from discharge|||||||
1376188|NCT01495975|Primary|Glycemic Control|Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge|1 month from discharge||||mg/dL||Standard Deviation|Mean
1376189|NCT01495923|Secondary|Proceeded to Surgery Within Year of Enrollment|This is a measure of participants that proceeded to surgery within a year of enrollment|Measured within the year of enrollment in the study|Data for this outcome measure was collected one year following the last follow-up. Data was not available for one participant in the epidural steroid injection arm and for three in the gabapentin arm.|||Participants|||Count of Participants
1376190|NCT01495923|Secondary|Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
1376191|NCT01495923|Secondary|Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month from the start of treatment||||units on a scale||Standard Deviation|Mean
1376192|NCT01495923|Secondary|Global Perceived Effect of Treatment at 1 Month After the Start of Treatment|"The participant is asked Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 1 month after the start of treatment."|1 month after the start of treatment||||Participants|||Count of Participants
1376193|NCT01495923|Secondary|Global Perceived Effect of Treatment at 3 Months After the Start of Treatment|"The participant is asked Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 3 months after the start of treatment."|3 months after the start of treatment||||Participants|||Count of Participants
1376863|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Month||Throughout study period (approximately 17 months)||||IU/kg per month||Standard Deviation|Mean
1376196|NCT01495923|Secondary|Average Back Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment||||units on a scale||Standard Deviation|Mean
1376197|NCT01495923|Secondary|Average Back Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month fromt he start of treatment||||units on a scale||Standard Deviation|Mean
1376198|NCT01495923|Primary|Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the worst leg pain at baseline to the worst leg pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment||||units on a scale||Standard Deviation|Mean
1376199|NCT01495923|Primary|Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month from the start of treatment||||units on a scale||Standard Deviation|Mean
1376200|NCT01495923|Primary|Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 3 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment||||units on a scale||Standard Deviation|Mean
1376201|NCT01495923|Primary|Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month after the start of treatment||||units on a scale||Standard Deviation|Mean
1376202|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2||Baseline and day 2|Safety Population|||Breaths/min||Standard Deviation|Mean
1376203|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2||Baseline and day 2|Safety Population|||Beats/min||Standard Deviation|Mean
1376204|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2||Baseline and Day 2|Safety Population|||mmHg||Standard Deviation|Mean
1376205|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2||Baseline and day 2|Safety Population|||mmHg||Standard Deviation|Mean
1376206|NCT01495858|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376207|NCT01495858|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population|||participants|||Number
1376208|NCT01495858|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
1376209|NCT01495858|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
1376210|NCT01495858|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
1376211|NCT01495858|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
1376212|NCT01495858|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
1376213|NCT01495858|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
1376214|NCT01495858|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent.|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
1376864|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Year||Throughout study period (approximately 17 months)||||Infusions per year||Standard Deviation|Mean
1376217|NCT01495858|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376218|NCT01495858|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376219|NCT01495858|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376220|NCT01495858|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376221|NCT01495858|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376222|NCT01495858|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1376223|NCT01495858|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
1376224|NCT01495858|Secondary|Total Sleep Time Measured by Actigraphy|Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1376225|NCT01495858|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
1376226|NCT01495858|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1376227|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1376228|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1376229|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1376257|NCT01495000|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Blood samples were collected for the measurement of red blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1376230|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1376231|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
1376232|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
1376233|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
1376234|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (liter per hour)||95% Confidence Interval|Least Squares Mean
1376235|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
1376236|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
1376237|NCT01495702|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set|||percentage of participants|||Number
1376238|NCT01495702|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: participants were randomized, received at least 1 dose of study drug, had no documented resistance, and were on an NNRTI at screening|||percentage of participants|||Number
1376239|NCT01495689|Secondary|Rate of Recruitment and Retention|Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial|6 months|||||||
1376240|NCT01495689|Secondary|Cost-effectiveness Analysis|We will measure direct and indirect costs of the intervention and perform cost-effectiveness analysis of the intervention provided in the out-patient setting with a dedicated nurse available to deliver the intervention.|6 months|||||||
1376241|NCT01495689|Primary|Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.|The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be >10 ppm, the subject will be considered a smoker.|6 months||||Participants|||Count of Participants
1376242|NCT01495585|Secondary|ALT Levels||7 months||||U/L||Standard Deviation|Mean
1376245|NCT01495572|Primary|Clinical Tumor Response|Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|One year||||participants|||Number
1376246|NCT01495481|Secondary|Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration|Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension.|10 minutes||||participants|||Number
1376247|NCT01495481|Secondary|Number of Participants With Tachyarrhythmias After Medication Administration|Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration|10 minutes||||participants|||Number
1376248|NCT01495481|Secondary|Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT|Evaluation of the number of participants with sinus pause > 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination|1 minute||||participants|||Number
1376249|NCT01495481|Primary|Termination of SVT|Number of participants with SVT Termination within 3 minutes of medication administration|Within 3 minutes||||participants|||Number
1376250|NCT01495286|Secondary|Skin Assessment|Areas of skin where the Stim Care electrodes are placed will be assessed for redness, tenderness, or any other change in skin condition. Assessment will take place at baseline, after the NESAP procedure, upon discharge from the hospital, and after one week. If there is a problem at one week, there will be additional follow-up at two weeks.|Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants,we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one sided paired t test|||participants|||Number
1376251|NCT01495286|Secondary|Pain During TENS Treatment and Routine Heel Stick|Pain scores were measured using the Premature Infant Pain Profile (PIPP). The PIPP is a composite pain tool that measures pain based on behavioral and physiologic parameters and adjusts for gestational age. Differences in pain scores were recorded throughout the heel stick process, using a baseline score as reference. Mean pain scores were calculated before NESAP (baseline), after the TENS unit was turned on, after ten minutes of NESAP but before heel stick, during heel cleaning, during the initial heel stick, during heel squeeze, and during recovery. For term infants, the range of PIPP scores is on a scale of 0 for no pain to 18 for severe pain. A score of 6 indicate mild pain, and a score of 11 -12 indicates moderate pain. An increase in PIPP score of 4 or greater from baseline indicates a significant change in pain level.|Pain score given during the heel stick process and for 2 minutes afterwards|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.|||units on a scale||Standard Deviation|Mean
1376252|NCT01495286|Secondary|Blood Pressure During TENS Treatment and Heel Stick|Changes in systolic and diastolic blood pressure after initial baseline. Measurements will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.|||mm Hg||Standard Deviation|Mean
1376253|NCT01495286|Primary|Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick|Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.|Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant increase in pain level. With 30 infants, we had 90% power to detect a significant increase in PIPP score with a .05 level, one-sided paired t-test.|||percentage of oxygen saturation||Standard Deviation|Mean
1376254|NCT01495286|Primary|Heart Rate During Treatment With TENS Unit|Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.|||beats per minute||Standard Deviation|Mean
1376255|NCT01495000|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6|The number of participants with positive and negative results for both neutralizing antibodies to denosumab and for binding antibodies to denosumab at Month 6 are summarized.|Month 6|ITT Population. Only participants available at the specified time point were analyzed.|||participants|||Number
1376256|NCT01495000|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Blood samples were collected for the measurement of red cell distribution width values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||percentage||Standard Deviation|Mean
1376865|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Month||Throughout study period (approximately 17 months)||||Infusions per month||Standard Deviation|Mean
1376258|NCT01495000|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Blood samples were collected for the measurement of mean corpuscular volume values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||femtoliters||Standard Deviation|Mean
1376259|NCT01495000|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Blood samples were collected for the measurement of hemoglobin values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||picograms||Standard Deviation|Mean
1376260|NCT01495000|Secondary|Change From Baseline in Hematocrit at Month 6|Blood samples were collected for the measurement of hematocrit values. Change from Baseline was calculated as the Month 6 value minuse the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||proportion of RBCs in blood||Standard Deviation|Mean
1376261|NCT01495000|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Blood samples were collected for the measurement of calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglyceride, urea/BUN, and VLDL cholesterol calculation values. Change from Baseline was calcualted as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||millimoles per liter (MMOL/L)||Standard Deviation|Mean
1376262|NCT01495000|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||micromoles per liter (UMOL/L)||Standard Deviation|Mean
1376263|NCT01495000|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6|Blood samples were collected for the measurement of basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil, total neutrophil, platelet count, and white blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1376264|NCT01495000|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6|Blood samples were collected for the measurement of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatinine kinase, gamma glutamyl transferase, and lactate dehydrogenase values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1376265|NCT01495000|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6|Blood samples were collected for the measurement of albumin, hemoglobin, mean corpuscle hemoglobin concentration, and total protein values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||grams per liter (g/L)||Standard Deviation|Mean
1376266|NCT01495000|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Blood samples were collected for the measurement of albumin/globulin ratio and BUN/creatinine ratio values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||ratio||Standard Deviation|Mean
1376267|NCT01495000|Secondary|Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6|The number of participants with laboratory parameter values of potential clinical concern at Month 6 are summarized. The following are the laboratory values of potential clinical concern: alkaline phosphatase, High: >375 units/Liter (L); aspartate aminotransferase, High: >165 units/L; creatinine, High: >159 micromoles (µmol)/L; glucose, Low: <3 millimoles (mmol)/L; hematocrit, Low: <0.325; hemoglobin, Low: <91grams/L; phosphorus, High: >1.723 mmol/L; potassium, High: >6.3 mmol/L; sodium, Low: <130 mmol/L; total neutrophils, Low: <0.9 10^9 cells (GI)/L; blood urea nitrogen (BUN), High: >21mmol/L; uric acid, High: 654 µmol/L.|Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||participants|||Number
1376279|NCT01494818|Secondary|Protective Index|A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Percent of visible contact lens surface||Standard Deviation|Mean
1390739|NCT01349959|Secondary|Progression-free Survival|Estimated using the method of Kaplan-Meier.|At 6 months||||months||95% Confidence Interval|Median
1376268|NCT01495000|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6|"Vital sign values of potential clinical concern were defined as: change in heart rate >30 beats per minutes (bpm), change in systolic blood pressure (SBP) >30 millimeters of mercury (mmHg), and change in diastolic blood pressure (DBP) >20 mmHg. The number of participants with post-Baseline vital sign values of potential clinical concern who did not have values of potential clinical concern at Baseline are summarized. If the change from Baseline is a decrease greater than the threshold, it is categorized as “low.” If the change from Baseline is an increase greater than the threshold, it is categorized ad “high."|Baseline; Months 1, 3, and 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||participants|||Number
1376269|NCT01495000|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|ITT Population: all participants who received one dose of study medication|||participants|||Number
1376270|NCT01495000|Secondary|Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6|Blood samples were collected for the measurement of s-CTx and s-PINP, which are used as biomarkers of bone resorption and formation, respectively. The median percent change from Baseline in s-CTX and s-PINP markers at Months 1, 3, and 6 was calculated as: (post-Baseline value minus Baseline value) * 100 / Baseline value.|Baseline; Months 1, 3, and 6|ITTE Population. Only participants with s-CTX and s-PINP values at both Baseline and Months 1, 3, and 6 were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITTE Population.|||percent change||Inter-Quartile Range|Median
1376271|NCT01495000|Secondary|Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6|BMD at the total hip, femoral neck, and trochanter was measured by the DXA scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate).|Baseline and Month 6|ITTE Population. Only participants with BMD values at both Baseline and Month 6 were analyzed.|||percent change||Standard Error|Least Squares Mean
1376272|NCT01495000|Primary|Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6|Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all randomized participants who received one dose of study medication, and who had a Baseline measure and at least one post-Baseline efficacy measure during the Double-blind Treatment Phase. Only participants with BMD values at both Baseline and Month 6 were analyzed.|||percent change||Standard Error|Least Squares Mean
1376273|NCT01494987|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1376274|NCT01494987|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1376275|NCT01494987|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations, analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1376276|NCT01494987|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.|||percent of HbA1c in blood||Standard Deviation|Mean
1376277|NCT01494818|Secondary|Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||micrograms||Standard Deviation|Mean
1376278|NCT01494818|Secondary|Median Front Lens Deposits|Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Units on a scale||Full Range|Median
1376280|NCT01494818|Primary|Change From Baseline in Upper Eyelid Margin Staining at Month 3|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||square millimeters||Standard Deviation|Mean
1376281|NCT01494818|Primary|Upper Lid Redness|The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Percentage of total surface measured||Standard Deviation|Mean
1376282|NCT01494818|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Seconds||Standard Deviation|Mean
1376283|NCT01494818|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Units on a scale||Full Range|Median
1376284|NCT01494818|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Units on a scale||Full Range|Median
1376285|NCT01494753|Primary|Mean Intra Ocular Pressure (IOP) at 8.00am|Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.|Day 42 and Day 84 (8.00am for the IOP)|Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment.|||mmHg||Standard Deviation|Mean
1376286|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
1376287|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
1376288|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.|Baseline and immediately after treatment administration|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
1376289|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
1376984|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Steady State Concentration to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, steady-state concentrations.|100 days||||mcg/mL||Full Range|Median
1376290|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
1376291|NCT01494649|Primary|Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.|Baseline and immediately after treatment administration|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
1376292|NCT01494610|Secondary|Number of Participants With an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization (Day 1) up to Follow-up (Days 47-50)|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1376293|NCT01494610|Secondary|Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)|"Blood samples of participants were collected for the evaluation of calcium, chloride, glucose, potassium, sodium, carbon dioxide (CO2) content/bicarbonate, and urea/BUN. All of these parameters are measured to help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||µmol/L||Standard Deviation|Mean
1376294|NCT01494610|Secondary|Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid|"Blood samples of participants were collected for the evaluation of DP, TB, creatinine, and uric acid. DB and TB are measures that help assess the condition of the liver, and creatinine and uric acid are measures that help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1376295|NCT01494610|Secondary|Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)|"Blood samples of participants were collected for the evaluation of AP, ALT, AST, and GGT. All of these parameters are measured to help assess the condition of the liver. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
1376296|NCT01494610|Secondary|Mean Albumin and Total Protein|"The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||g/L||Standard Deviation|Mean
1376297|NCT01494610|Secondary|Mean Hematocrit|"Blood samples of participants were collected for the evaluation of hematocrit. The hematocrit is the percentage of the RBCs in the blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||percentage of RBCs||Standard Deviation|Mean
1376317|NCT01494610|Secondary|Mean AUC(0-tlast) for FP|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tlast). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||pg*h/mL||95% Confidence Interval|Geometric Mean
1376298|NCT01494610|Secondary|Mean Corpuscle Volume (MCV)|"Blood samples of participants were collected for the evaluation of MCV. MCV is a measure of the average red blood cell size that is reported as part of a standard complete blood count. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Femtoliters (fL; 10^-15 L)/cell||Standard Deviation|Mean
1376299|NCT01494610|Secondary|Mean Corpuscule Hemoglobin (MCH)|"Blood samples of participants were collected for the evaluation of MCH. MCH is the average mass or amount of hemoglobin per red blood cell in a sample of blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subject Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||picograms (pg)/cell||Standard Deviation|Mean
1376300|NCT01494610|Secondary|Red Blood Cell (RBC) Count and Reticulocytes|"Blood samples of participants were collected for the evaluation of RBC and reticulocytes count. Reticulocytes are immature red blood cells. Normally, about 1% to 2% of the red blood cells in the blood are reticulocytes. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Trillion (10^12) cells/L||Standard Deviation|Mean
1376301|NCT01494610|Secondary|Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration|"Blood samples of participants were collected for the evaluation of mean hemoglobin (mean level of hemoglobin in the whole blood sample) and MCH concentration. The MCH concentration is the average concentration of hemoglobin in a red blood cell. Hemoglobin is the red pigment in the blood, and it is reponsible for carrying oxygen. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1376302|NCT01494610|Secondary|Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count|"Blood samples of participants were collected for the evaluation of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and WBC count. Data are reported for the first (1st) and second (2nd) administration (admin) of FP/salmeterol via MDPI or capsule-based inhaler. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population: all participants who received at least one dose of study medication. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Giga (10^9) cells/L||Standard Deviation|Mean
1376303|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the maximum plasma glucose level. Weighted mean was calculated by using all values of plasma glucose at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||mmol/L||Standard Deviation|Mean
1376304|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the minimum plasma potassium level. Weighted mean was calculated by using all values of plasma potassium at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Only those participants contributing data at the indicated time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1376305|NCT01494610|Secondary|Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett’s Formula (QTc[B]) and the QT Interval Corrected According to Fridericia’s Formula (QTc[F])|The electrocardiogram (ECG) of the participants was taken, and the maximum and weighted mean of QTc(B) and QTc(F) was measured. Weighted mean was calculated by using all values of QTc(B) and QTc(F) at the indicated timepoint contributing to the calculation of the mean but with different weightage. The ECG helps in the assessment of the condition of the heart. The QT interval gives the measure of the heart rate, and the cQT interval gives the corrected value.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 3 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||Milliseconds (msec)||Standard Deviation|Mean
1376985|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Clearance to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, clearance.|100 days||||mL/min/kg||Full Range|Median
1376306|NCT01494610|Secondary|Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose|The diastolic and systolic blood pressure of the participants was measured. The maximum and minimum observed values from the time of the morning dose on Day 10 to 4 hours post dose were measured for SBP and DBP. The weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. Weighted mean was calculated by using all values of DBP and SBP at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1376307|NCT01494610|Secondary|Mean of Maximum Heart Rate Over 0 to 4 Hours Post Dose for Salmeterol|The maximum observed value of heart rate was measured from the time of the morning dose on Day 10 to 4 hours post dose.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||bpm||Standard Deviation|Mean
1376308|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Heart Rate for Salmeterol|The heart rate (number of heartbeats per unit of time, typically expressed as beats per minute [bpm]) of the participants was monitored for evaluating the weighted mean over the course of 0 to 4 hours post dose. The Capsule-MDPI difference for heart rate was calculated for each participant, and the weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. The weighted mean was calculated by using all values at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||bpm||Standard Deviation|Mean
1376309|NCT01494610|Secondary|Serum Cortisol Minimum (Cmin) for FP|Blood samples of participants were collected for the evaluation of minimum serum cortisol. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in serum cortisol concentrations.|Day 10 of each study period (Periods 1-4); Study Day 10 (+/-1) (reference day is Study Day 1 or Randomization day), Period 1; Study Day 20 (+/-1), Period 2; Study Day 30 (+/-1), Period 3; Study Day 40 (+/-1), Period 4|PK/PD Population|||nmol/L||95% Confidence Interval|Geometric Mean
1376310|NCT01494610|Secondary|Mean Urine Cortisol Excretion Over 0 to 24 Hours Post Dose for FP|Urine samples of participants were collected to evaluate urine cortisol excretion over 0-24 hours post treatment dose. A 24-hour urine cortisol sample was used to measure the total amount of cortisol excreted in urine in 24 hours. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in the amount of cortisol excreted in the urine.|0-24 hours post dose on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||nmol||95% Confidence Interval|Geometric Mean
1376311|NCT01494610|Secondary|Tmax for Salmeterol|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||hours||Full Range|Median
1376312|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for Salmeterol|Blood samples of participants were collected for evaluating t1/2. t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.|||hours||95% Confidence Interval|Geometric Mean
1376313|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of Salmeterol in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||pg/mL||95% Confidence Interval|Geometric Mean
1376314|NCT01494610|Secondary|Time of Occurrence of Cmax (Tmax) for FP|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||hours||Full Range|Median
1376315|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for FP|Blood samples of participants were collected for evaluating t1/2. The t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.|||hours||95% Confidence Interval|Geometric Mean
1376316|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of FP in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum, respectively.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||Picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1376318|NCT01494610|Secondary|Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tau) and AUC(0-tlast). AUC(0-tau) is a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||pg*h/mL||95% Confidence Interval|Geometric Mean
1376319|NCT01494610|Primary|Weighted Mean Serum Cortisol (SC) Over 0 to 12 Hours Post Dose|Participants' blood samples were collected and analyzed for SC levels. Weighted mean SC levels are evaluted as a measure of the degree of cortisol suppression, allowing for the determination of whether differences in systemic exposure to the inhaled steroid component of two devices can be significant enough to result in the differences in the body’s ability to release cortisol. Weighted means were derived by calculating the AUC over the 0-12 hour period, using the linear trapezoidal rule (statistical technique used for numerical analysis) and then dividing it by the actual time interval.|At pre-morning dose; 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||Nanomoles per liter (nmol/L)||95% Confidence Interval|Geometric Mean
1376320|NCT01494610|Primary|Mean Area Under the Concentration Time Curve Over the Dosing Period (AUC[0-tau]) for FP|Blood samples of participants (par.) with asthma and chronic obstructive pulmonary disease (COPD) were collected and analyzed for AUC(0-tau), a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to difficulty in breathing. COPD is a chronic lung disease with structural changes in lungs, leading to difficulty in breathing.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Pharmacokinetic/pharmacodynamic (PK/PD) Population: all participants who received at least one dose of study medication, except for one who was identified as a full protocol violator. Participants with at least one non-missing value in the replicate observations were included.|||Picogram hours per milliliter (pg*h/mL)||95% Confidence Interval|Geometric Mean
1376321|NCT01494584|Secondary|Number of Participants With the Indicated Neurological Abnormality|Abnormal Central Nervous System (CNS) symptoms were assessed by a full and brief neurological examination. A full neurological examination included assessment of mental status, cranial nerves, gait, coordination, sensation, speech/language, muscle strength, muscle tone, and reflexes. A brief neurological examination included assessment of mental status, cranial nerves, gait, coordination, reflexes, and speech/language. Neurological parameters assessed were memory impairment, impaired intellect, decreased attention, psychomotor slowing, decreased muscle strength, hpertonia, somnolence, right and left bicpes, right and left brachioradialis, right and left knee, right and left ankle, and right and left planter response. Neurological examination was performed at Day 7 of Titration 3 (600 mg/day).|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population|||Participants|||Number
1376322|NCT01494584|Secondary|Change From Baseline in Post Void Residual Ultrasound at Day 21|A post void residual (PVR) bladder ultrasound was carried out as a measure of bladder function. PVR was clinically indicated following the occurrence of adverse events relating to the lower urinary tract (e.g., micturition difficulties, including urinary hesitancy or urinary retention). These assessments were also repeated following drug withdrawal following such events. A prompt follow-up PVR was recommended if a high score was obtained from a participant on the Pediatric Lower Urinary Tract Symptom scale (the PLUTS scale is a clinician-rated scale used to assess lower urinary tract symptoms, including urinary retention) and if the clinician felt that the participant was at risk or had symptoms of urinary retention. PVR was measured at Day 7 of Titration 3 (600 mg/day). Baseline is defined as the Screening visit.|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population|||ML||Standard Deviation|Mean
1376323|NCT01494584|Secondary|Change From Baseline in Heart Rate (HR)|Vital sign assessment included heart rate measurement and was assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.|||Beats per Minute (BPM)||Standard Deviation|Mean
1376324|NCT01494584|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Vital sign assessment included the measurement of systolic and diastolic blood pressure at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), Day 7 pre-dose, and 3 h post dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): Day 21 pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): Day 35 pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1376325|NCT01494584|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate (QTc intervals) was used. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). ECG parameters were assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose, and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. The number of participants with abnormal (Abn) clinically significant (CS) and not clinically significant (NCS) ECG findings was recorded. The investigator determined if an ECG finding was CS or NCS.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
1376326|NCT01494584|Secondary|Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma t1/2. Steady-state t1/2 is derived as (Vd/F) / (CL/F), where Vd/F is defined as the apparent volume of distribution after extravascular (e.g., oral) administration, and CL/F is defined as the apparent clearance following oral dosing.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population. Only those participants available at the indicated time point were analyzed.|||Hours||95% Confidence Interval|Geometric Mean
1376327|NCT01494584|Secondary|Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma Tmax.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population|||Hours||Full Range|Median
1376328|NCT01494584|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine|Ctau refers to the pre-dose (trough) concentration at the end of the dosing interval which is equivalent to the minimum observed concetration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the Ctau for n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population|||ng/mL||95% Confidence Interval|Geometric Mean
1376329|NCT01494584|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine|The area under the curve was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the plasma n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population|||h*ng/mL||95% Confidence Interval|Geometric Mean
1376330|NCT01494584|Secondary|Percent Change From Baseline in 28-day Seizure Frequency Rate|Participants or their caregivers recorded the number of seizures experienced by the participant, by seizure type (e.g., simple partial seizure [seizure that affects only a small region of the brain; consciousness is unaffected], complex partial seizure [seizure associated with unilateral cerebral hemisphere involvement and causing impairment of awareness or responsiveness], etc.), as well as by duration of episodes of innumerable seizure activity, in their daily diaries during all phases of this study. Percent change from baseline is defined as 100 * (rate in a given period minus the baseline rate) / (baseline rate). baseline seizures are defined as those seizures that occurred after Screening and before the start of the treatment. Post-baseline seizures are defined as those seizures that occurred from the start of the treatment until the start of Follow-up. Seizure frequency rate was computed as: 28 * (number of seizures during given period / number of days in given period).|Baseline (Screening) and until Follow-up or early discontinuation (assessed up to 46 days)|All Subjects Population. Only participants with baseline and post-baseline seizure measurements were included in the analysis.|||Percent change||Standard Deviation|Mean
1376331|NCT01494584|Secondary|Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up|Urinalysis parameters analyzed included: urine occult blood (UOB), urine glucose (UG), urine ketones (UK), and urine protein (UP). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test provides results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, and 80, indicating proportional concentrations in the urine sample. Urinalysis parameters were assessed at Titration 1 (T1; 300 mg/day), Titration 2 (T2; 450 mg/day), Titration 3 (T3; 600 mg/day), Titration 4 (T4; 750 mg/day), and Titration 5 (T5; 900 mg/day).|Screening, Day 1 (D1), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), Day 35 (D35), and at the Follow-up Visit (up to Day 46)|All Subjects Population (ASP). Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points and for different parameters, so the overall number of participants analyzed reflects everyone in the ASP.|||Participants|||Number
1376332|NCT01494584|Secondary|Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||10^12 cells/L (TI/L)||Standard Deviation|Mean
1376425|NCT01493947|Other Pre-specified|Time to Relapse|Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.|Week 16 up to Week 52||||Median days to relapse||95% Confidence Interval|Median
1390740|NCT01349959|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|Up to 3 years||||months||95% Confidence Interval|Median
1376333|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
1376334|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||Picograms (PG) per cell (PG/cell)||Standard Deviation|Mean
1376335|NCT01494584|Secondary|Change From Baseline in Hematocrit at Day 7 Post Each Up-titration|"Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. The International System of Units (SI) Fraction of one unit (1) is reported here."|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||Fraction of one unit (1)||Standard Deviation|Mean
1376336|NCT01494584|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1376337|NCT01494584|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Giga (10^9) cells per liter (GI/L)||Standard Deviation|Mean
1376338|NCT01494584|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
1376339|NCT01494584|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
1376340|NCT01494584|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International Units per Liter (IU/L)||Standard Deviation|Mean
1376341|NCT01494584|Secondary|Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per Liter (G/L)||Standard Deviation|Mean
1376426|NCT01493947|Primary|Percent Change in Inflammatory Lesions From Baseline to Week 16|Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period|Baseline and Week 16||||percentage of change||Standard Deviation|Mean
1376342|NCT01494584|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|From the start of the first titration until follow-up (assessed up to 46 days)|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
1376343|NCT01494584|Primary|Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine|The volume of distribution (Vd/F) is defined as MRT*CL/F, where MRT is the mean residence time (calculated as AUMC[0-tau]/AUC[0-tau], where AUMC[0-tau] is the area under the first moment curve determined as the area under the concentration*time versus time curve). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate the apparent volume of distribution.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Geometric Mean
1376344|NCT01494584|Primary|Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine|Cmax is defined as the first occurrence of the maximum observed plasma concentration. Ctau refers to the pre-dose (trough) concentration after the dosing interval which is equal to the minimum observed concentration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate Cmax and Ctau.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population|||Nanograms/Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1376345|NCT01494584|Primary|Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine|Clearance (CL/F) is defined as dose/AUC(0-tau). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate CL/F.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population|||Liters/Hour||95% Confidence Interval|Geometric Mean
1376346|NCT01494584|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine|The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC[0-tau]). The area under the plasma concentration-time curve over the dosing interval (AUC[0-tau]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate AUC(0-tau).|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of study medication) for whom a pharmacokinetic sample was obtained and analyzed|||Hour*Nanograms/Milliliter (h.ng/mL)||95% Confidence Interval|Geometric Mean
1376347|NCT01494545|Primary|Likert Statement: I am Interested in Purchasing These Contact Lenses.|The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376348|NCT01494545|Primary|Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:|The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376349|NCT01494545|Secondary|Investigator's Rating of Ease of Fit|"The investigator indicated agreement/disagreement with the statement, The study lenses were easy to fit for this subject, by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree."|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376350|NCT01494545|Secondary|Investigator's Overall Impression of Surface Wettability by Visit|The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376351|NCT01494545|Secondary|Investigator's Satisfaction With Lens Fit by Visit|The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376352|NCT01494545|Secondary|Duration of Overall Training Time|The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Minutes||Standard Deviation|Mean
1376353|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of eyes|Participants||Number
1376427|NCT01493687|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT|||Percentage of change in lesion counts||Standard Deviation|Mean
1376354|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 7|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of eyes|Participants||Number
1376355|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of eyes|Participants||Number
1376356|NCT01494545|Primary|Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376357|NCT01494545|Primary|Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376358|NCT01494545|Primary|Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376359|NCT01494545|Primary|Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376360|NCT01494545|Primary|Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376361|NCT01494545|Primary|Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376362|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376363|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
1376364|NCT01494545|Primary|Average Comfortable Daily Wear Time by Visit|Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Hours||Standard Deviation|Median
1376365|NCT01494545|Primary|Overall Quality of Vision by Visit|Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376366|NCT01494545|Primary|Quality of Vision at End of Day by Visit|Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376367|NCT01494545|Primary|Quality of Vision During the Day by Visit|Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376428|NCT01493687|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT|||Lesion count change||Standard Deviation|Mean
1376368|NCT01494545|Primary|Quality of Vision at Insertion by Visit|Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376369|NCT01494545|Primary|Initial Quality of Vision|Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376370|NCT01494545|Primary|Overall Comfort by Visit|Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376371|NCT01494545|Primary|Comfort at End of Day by Visit|Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376372|NCT01494545|Primary|Comfort During the Day by Visit|Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376373|NCT01494545|Primary|Comfort at Insertion by Visit|Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376374|NCT01494545|Primary|Initial Comfort|Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
1376375|NCT01494532|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here. All participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.|From start of study treatment until end of treatment (assessed up to 18 weeks)|ITT Population. Participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.|||Percentage of participants|||Number
1376376|NCT01494532|Secondary|Change From Baseline in UPDRS Part I at Week 4 of the Maintenance Period|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and par. were tested during the on phase of PD. This component of the UPDRS is the total score for 4 items (the items 1 to 4 include intellectual impairment, thought disorder, motivation / initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician. The higher score (16) indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component would also be missing. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline (BL) and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
1376377|NCT01494532|Secondary|"Change From Baseline in UPDRS ADL Score With Participants in an Off State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test was performed when the par is in the off state of PD. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
1376378|NCT01494532|Secondary|"Change From Baseline in UPDRS Activities of Daily Living (ADL) Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test were performed when the par. is in the on state of PD. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
1376986|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF AUC to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, area under the plasma concentration versus time curve (AUC).|100 days||||mcg*hr/mL||Full Range|Median
1376379|NCT01494532|Secondary|"Change From Baseline in Unified Parkinson Disease Rating Scale (UPDRS) Motor Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the par.. One of the six features include the Part III-motor examination where scores can range 0 to 108 with par. in an on state where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
1376380|NCT01494532|Secondary|Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep as a Percentage of a 24-hour Day, at Week 4 of the Maintenance Period|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. The percentage of a 24-hour day spent asleep during the night time hours = Total sleep hours during the night time hours of sleep divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Percentage of time in hours||95% Confidence Interval|Least Squares Mean
1376381|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of a 24-hour day spent on = Awake time spent on divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
1376382|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24- Hour Day Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit. The total number of day awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percentage of 24 hr day spent on without TD= awake time spent on without TD divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
1376383|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of 24 hour day spent off= awake time spent off divided by 24 x 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
1376384|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of awake time spent on= Awake time spent on divided by (Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
1376462|NCT01493024|Secondary|Serum Sodium (S-Na) Levels|Serum sodium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
1376987|NCT01487577|Secondary|Number of Participants in Overall Survival.||1 year||||participants|||Number
1376385|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit of the study. The total number of awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hr spent on without TD in each 24-hr diary card. Percentage of awake time spent onwithout TD= Awake time spent on without TD divided by(Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting BL values from MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
1376386|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility(bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of awake time spent off= Awake time spent off divided by (Awake time spent off + Awake time spent on) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
1376387|NCT01494532|Secondary|Percent Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep, at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL value × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Percentage of total sleep time in hours||95% Confidence Interval|Least Squares Mean
1376388|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to recordawake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
1376389|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
1376390|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values multiplied (×) the results with 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
1376443|NCT01493427|Secondary|Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.|||Percentage of participants|||Number
1376391|NCT01494532|Secondary|Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
1376392|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on at Week 4 of the Maintenance Period"|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of the awake hours spent on in each 24 hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
1376393|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in Parkinson's Disease (PD). TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24 hour diary card. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from Mixed Model Repeated Measures (MMRM). Par with a non-missing efficacy observation at BL and during the MP were analyzed."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
1376394|NCT01494532|Secondary|Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2. The Generalized Estimating Equations (GEE) model was used to determine CGI responder rate with treatment, visit, and treatment by visit interaction included in the model. Only scheduled visits were included."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Percentage of participants|||Number
1376395|NCT01494532|Secondary|"Percentage of Participants With a >=2 Hours Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||percentage of participants||95% Confidence Interval|Least Squares Mean
1376396|NCT01494532|Secondary|"Percentage of Participants With a >=1 Hour Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||percentage of participants||95% Confidence Interval|Least Squares Mean
1376397|NCT01494532|Secondary|"Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period"|"The responder rate was defined as the percentage of par with greater than or equal to (>=) 20 percent (%) reduction in their individual BL off time at Week 4 of the Maintenance Period. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. Responder Rate (Least Squares [LS] means on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline total awake time 'Off', treatment, visit and treatment*visit are included in the model."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||percentage of participants||95% Confidence Interval|Least Squares Mean
1376398|NCT01494532|Primary|"Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period"|"Off time is defined as the state in which the participants(par) symptoms include lack of mobility(bradykinesia) with or without additional features such as tremor or rigidity. Par were asked to record awake time “off ”, awake time on, troublesome dyskinesias(TD) during awake time on, or time asleep for 30 minute intervals in 24 hr diary cards for 2 days preceding visits. Total number of awake hrs spent off per 24-hr period was the average of the 2 diary cards of the sum of awake hours spent off in each 24-hr diary card. BL is the last non-missing assessment measured on or before the first dose, change from BL was calculated by subtracting the BL values from the MP Week 4 values. Mixed Model Repeated Measures (MMRM) model used BL total awake time 'Off', treatment, visit and treatment by visit"|Baseline and Week 4 of the Maintenance Period (Study Week 17)|The Intent to Treat(ITT) Population included all randomized par who received at least one dose of study medication, had a BL efficacy assessment for the outcome, and at least one respective Post-BL efficacy assessment. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
1376399|NCT01494506|Secondary|Pharmacokinetic Measurements of Total Irinotecan|Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.|6 weeks after first study drug administration|PK population was based on Protocol, all participants who received the appropriate dose of MM-398.|||Total irinotecan = ug/L; SN38= ug/L||Geometric Coefficient of Variation|Geometric Mean
1376400|NCT01494506|Secondary|EORTC-QLQ-C30|This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.|||percent of patients in category|||Number
1376401|NCT01494506|Secondary|Percentage of Patients With Tumor Marker (CA 19-9) Response|Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|Patients with elevated baseline CA19-9 value (> 30 U/mL) who received study drug.|||percent of participants with TMR|||Number
1376402|NCT01494506|Secondary|Percentage of Patients With Clinical Benefit Response|"Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either:~(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.~With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.~Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period."|Randomization to treatment discontinuation.The maximum time in follow up was 25 months|"Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR:~baseline pain intensity ≥ 20 (out of 100)~baseline morphine consumption ≥ 10 mg/day PO morphine equivalents~baseline KPS of 70 to 90 points"|||percentage of participants with CBR|||Number
1376403|NCT01494506|Secondary|Time to Treatment Failure|Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.|Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months|ITT Population|||months||95% Confidence Interval|Median
1376404|NCT01494506|Secondary|Objective Response Rate|The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.|Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.|ITT Population|||percentage with confirmed response||95% Confidence Interval|Number
1376405|NCT01494506|Secondary|Progression Free Survival|"Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|Randomization until disease progression or death from any cause; Until the data cut off of 14 Feb 2014. The maximum time in follow up was 25 months.|ITT Population|||months||95% Confidence Interval|Median
1376623|NCT01491035|Primary|AUC(0-24h) of Vortioxetine|Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||ng*h/mL||Standard Deviation|Median
1376406|NCT01494506|Primary|Overall Survival|"Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.|Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.|||months||95% Confidence Interval|Median
1376407|NCT01494467|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12||||Percentage of change in lesion counts||Standard Deviation|Mean
1376408|NCT01494467|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT|||Lesion count change||Standard Deviation|Mean
1376409|NCT01494467|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT|||Percentage of participants|||Number
1376410|NCT01494350|Secondary|Number of All Ulcerated Lesions With Reepithelialization on Day 28|Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28|Measured on day 28|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.|||lesions|Participants||Number
1376411|NCT01494350|Secondary|Area of All Ulcerated Lesions Throughout the Study|Area of all ulcerated lesions on Days 20, 28, 42, and 98.|Measured at day 20, 28, 42 and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (2 lesions) who withdrew on Day 18.|||mm^2|Participants|Standard Deviation|Mean
1376412|NCT01494350|Secondary|Number of Index Lesions With Reepithelialization Throughout the Study|Number of index lesions with 100% reepithelialization on Days 28 and 42.|Measured at day 28 and 42|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.|||lesions|Participants||Number
1376413|NCT01494350|Secondary|Area of Index Lesions Throughout the Study|Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.|Measured at day 0, 20, 28, 42, and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (1 index lesion) who withdrew on Day 18.|||mm^2|Participants|Standard Deviation|Mean
1376414|NCT01494350|Primary|Final Clinical Cure Rate for the Index Lesion|Number of index lesions with 100% reepithelialization at Day 98.|Final clincial cure is measured at day 98|modified intent to treat (mITT)|||lesions|Participants||Number
1376415|NCT01494298|Secondary|Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.||at study entry||||mg/dL||Standard Error|Least Squares Mean
1376416|NCT01494298|Secondary|LDL Density in African American Males With Diabetes and Those Without Diabetes|"LDL size subclassification was divided into the following groups (from largest size to smallest size): LDL I, LDL IIa, LDL IIb, LDL IIIa, LDL IIIb, LDL IVa, LDL IVa, and LDL IVb.~For differences posted P<0.05 for LDL I, LDL IIb, LDL IIIa, and LDL IIIa +b"|at entry||||percentage of total LDL particles||Standard Error|Least Squares Mean
1376417|NCT01494298|Primary|ApoB Levels in African American Men With Diabetes and Those Without.|Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.|At study entry||||mg/dL||Standard Error|Least Squares Mean
1376418|NCT01493960|Secondary|The Induction of Registration Remission|Percentage of participants with induction of registration remission, defined as a CAI score of ≤4 and an endoscopic score of 0 or 1, at week 4 and 12.|Week 4 and 12|FAS|||Percentage of Subjects||95% Confidence Interval|Number
1376419|NCT01493960|Secondary|The Induction of Symptomatic Remission|Percentage of participants with induction of symptomatic remission, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively, at week 4 and 12.|Week 4, 12|FAS|||Percentage of Subjects||95% Confidence Interval|Number
1376420|NCT01493960|Secondary|The Induction of Mucosal Healing|Percentage of participants with induction of mucosal healing, defined as an endoscopic score of 0 or 1, at week 4 and 12.|Week 4 and 12|FAS|||Percentage of Subjects||95% Confidence Interval|Number
1376421|NCT01493960|Secondary|Steroid Free Remission at 12 Months|Percentage of participants with steroid free remission at 12 months after 1st dose.|at 12 months|FAS|||Percentage of Subjects||95% Confidence Interval|Number
1376422|NCT01493960|Secondary|The Rate of Colectomy|Percentage of participants undergoing colectomy at 12 months after 1st dose.|at 12 months|FAS|||Percentage of Subjects||95% Confidence Interval|Number
1376423|NCT01493960|Secondary|The Time to Colectomy|Median time to colectomy after 1st dose.|Within 12 months|FAS|||Time||95% Confidence Interval|Median
1376424|NCT01493960|Primary|Induction of Clinical Remission|The induction of clinical remission at week 12, defined as a CAI score of ≤4.(Full Analysis Set)|Week 12|The FAS consited of all randomized patients who met the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and received at least 1 dose of study drug (active or placebo), and who had at least 1 post randomization eligible value of the primary efficacy endpoint|||Percentage of participants||95% Confidence Interval|Number
1376429|NCT01493687|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT|||Percentage of participants|||Number
1376430|NCT01493557|Secondary|Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom|Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.|Week 8|Full Analysis Set (FAS)|||days||Standard Deviation|Mean
1376431|NCT01493557|Secondary|Rates of Complete or Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS).|||percentage of participants|||Number
1376432|NCT01493557|Secondary|Rates of Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
1376433|NCT01493557|Secondary|Rates of Complete Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full analysis Set (FAS).|||percentage of participants|||Number
1376434|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
1376435|NCT01493557|Secondary|Rate of Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
1376436|NCT01493557|Secondary|Rate of Complete Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
1376437|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)|||percentage of participants|||Number
1376438|NCT01493557|Secondary|Rate of Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)|||percentage of participants|||Number
1376439|NCT01493557|Primary|The Rate of Complete Effectiveness of Initial GIS Management Strategy|"The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 4|Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies.|||percentage of participants|||Number
1376440|NCT01493531|Secondary|Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 months||||Proportion of Subjects|||Number
1376441|NCT01493531|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12.|12 Months||||Gout Flares||Standard Deviation|Mean
1376442|NCT01493531|Primary|Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.|Proportion of subjects with an sUA level that is < 6.0 mg/dL by Month 6.|6 months|Intent-to-Treat Population|||Proportion of Subjects|||Number
1376988|NCT01487577|Secondary|Number of Participants Who Experienced Nonrelapse Mortality.||1 year||||participants|||Number
1376989|NCT01487577|Secondary|Number of Participants Who Experienced Relapse.||1 year||||participants|||Number
1376444|NCT01493427|Primary|Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|"The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit (N=187). Here, n is the number of participants with non-missing values at the specific time point."|||millimeters mercury (mmHg)||Standard Deviation|Mean
1376445|NCT01493284|Secondary|Number of Participants With Acute Device Success|"Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system~Correct position of the device in the proper anatomical location~Intended performance of the prosthetic heart valve (Aortic Valve Area >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR)~Only one valve implanted in the proper anatomical location"|7 days|Successful vascular access, delivery and deployment of the device|||Participants|||Count of Participants
1376446|NCT01493284|Secondary|Participant NYHA Classification at Day 30|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|day 30|Analysis for participants that completed visit and assessment|||Participants|||Count of Participants
1376447|NCT01493284|Secondary|Number of Select Cardiovascular Adverse Events|Number of participants with select cardiovascular adverse events|30 days||||participants|||Number
1376448|NCT01493284|Primary|All Cause Mortality|Number of participants that reported all cause mortality|30 days||||Participants|||Count of Participants
1376449|NCT01493180|Primary|Change in the Keratoconjunctival Staining Score From Baseline|"Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better.~The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test."|Basekine, 4 weeks||||scores on a scale||Standard Deviation|Mean
1376450|NCT01493167|Primary|Efficient Casting With Woodcast Circular System|Efficient casting conduc ted with Novel Woodcast material|1 - 6 weeks||||participants|||Number
1376451|NCT01493089|Secondary|Percentage of Patients Responding in 90 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes|14 days|mITT|||Percentage of patients||95% Confidence Interval|Number
1376452|NCT01493089|Secondary|Percentage of Patients Responding in 60 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes|14 days|mITT|||Percentage of patients||95% Confidence Interval|Number
1376453|NCT01493089|Secondary|Percentage of Patients Responding in 45 Minutes|percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes|up to 14 days|mITT|||percentage of patients||95% Confidence Interval|Number
1376454|NCT01493089|Secondary|Median Time to Sustained Total Relief|Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more|14 days|mITT|||Minutes||95% Confidence Interval|Median
1376455|NCT01493089|Secondary|Median Time to Sustained Partial Response|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days|mITT|||Minutes||95% Confidence Interval|Median
1376456|NCT01493089|Primary|Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days following treatment|mITT|||Minutes||95% Confidence Interval|Median
1376457|NCT01493024|Secondary|24-hour Urinary Excretion of Creatinine|24-hour urinary excretion of creatinine on Study Days 1 and Day 2|48 hours|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/24 hour||Standard Deviation|Mean
1376458|NCT01493024|Secondary|24-hour Urinary Excretion of Urea Nitrogen|24-hour urinary excretion of urea nitrogen on Study Days 1 and Day 2|48 hours|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||g/24 hour||Standard Deviation|Mean
1376459|NCT01493024|Secondary|24-hour Urinary Excretion of Sodium|24-hour urinary excretion of sodium on Study Days 1 and Day 2|48 hours|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/24 hour||Standard Deviation|Mean
1376460|NCT01493024|Secondary|24-hour Urinary Excretion of Potassium|24-hour urinary excretion of potassium on Study Days 1 and Day 2|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/24 hour||Standard Deviation|Mean
1376461|NCT01493024|Secondary|Serum Bicarbonate (HCO3) Levels|Serum bicarbonate compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
1376463|NCT01493024|Secondary|Serum Calcium (S-Ca) Levels|Serum calcium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
1376464|NCT01493024|Secondary|Serum Magnesium (S-Mg) Levels|Serum magnesium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
1376465|NCT01493024|Secondary|Blood Urea Nitrogen|Blood urea nitrogen compared between the combined placebo-treated controls and the ZS-treated subjects (measured 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
1376466|NCT01493024|Secondary|Urea Nitrogen Excretion|Urea nitrogen excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
1376467|NCT01493024|Secondary|Urine Potassium Excretion|Urine potassium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
1376468|NCT01493024|Secondary|Urine Sodium Excretion|Urine sodium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).|24 and 48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
1376469|NCT01493024|Secondary|Percentage of Participants With Normal S-K Levels at End of Study Day 2|Percentage (%) of subjects who achieve S-K normalization at end of Study Day 2|48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||percentage of participants|||Number
1376470|NCT01493024|Secondary|Time Specific Decreases in S-K Levels of > = 0.5 mmol/L|Percentage of participants achieving a 0.5mmol/L drop from baseline at Study Days 2 and 3 at 0 hr.|24 and 48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||percentage of participants|||Number
1376471|NCT01493024|Secondary|Time Specific S-K Levels to Normalization|Percent of subjects achieving S-K normalization (<=as defined by S-K levels of 3.5 to 4.9 mmol/L) from baseline at Study Days 2 and 3 at 0 hr.|48 and 72 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||percentage of participants|||Number
1376472|NCT01493024|Secondary|Serum Potassium (S-K) at Individual Time Points.|Serum potassium (S-K) at individual time points through Study day 3/0hour.|First 48 hours of study|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
1376473|NCT01493024|Primary|Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment|The rate of fall in S-K levels during the initial 48 hours of study drug treatment between the placebo treated subjects and the ZS treated subjects measured on a log scale|24 and 48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||log(mmol/L/hour)||Standard Error|Mean
1376474|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment||||Seconds||Standard Deviation|Mean
1376475|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment||||Incorrect Responses||Standard Deviation|Mean
1376476|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following baseline assessment||||Seconds||Standard Deviation|Mean
1376477|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following Baseline assessment||||Incorrect Responses||Standard Deviation|Mean
1376478|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following baseline assessment||||Correct responses||Standard Deviation|Mean
1376990|NCT01487577|Secondary|Number of Participants With Neutrophil and Platelet Engraftment.|Neutrophil and platelet engraftment definitions as defined by the CIBMTR Data Management Manual.|100 days||||participants|||Number
1376479|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following Baseline assessment||||Percentage of responses||Standard Deviation|Mean
1376480|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The Wcst is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
1376481|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment||||Percentage of responses||Standard Deviation|Mean
1376482|NCT01492439|Secondary|The Trail Making Part B at 6 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment||||Seconds||Standard Deviation|Mean
1376483|NCT01492439|Secondary|The Trail Making Test Part B at 3 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment||||Seconds||Standard Deviation|Mean
1376484|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|6 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
1376485|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|3 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
1376486|NCT01492439|Secondary|The Trail Making Test Part A at 6 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment||||Seconds||Standard Deviation|Mean
1376487|NCT01492439|Secondary|The Trail Making Test Part A at 3 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment||||Seconds||Standard Deviation|Mean
1376488|NCT01492439|Secondary|The California Verbal Learning Test at 6 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|6 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
1376489|NCT01492439|Secondary|The California Verbal Learning Test at 3 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|3 months following Baseline Assessment||||Correct responses||Standard Deviation|Mean
1376490|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 6 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|6 months following Baseline assessment||||units on a scale||Standard Deviation|Mean
1376491|NCT01492439|Secondary|The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|6 months following Baseline assessment||||units on a scale||Standard Deviation|Mean
1376492|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 3 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|3 months following Baseline||||units on a scale||Standard Deviation|Mean
1376493|NCT01492439|Secondary|Positive and Negative Symptoms Scale (PANSS) Score at 3 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|3 months following baseline||||units on a scale||Standard Deviation|Mean
1376494|NCT01492439|Primary|Completion of Academic Semesters|During the study period, course instructors provided information as to whether participants had completed or withdrawn from academic semester 1 and 2. This data was used to determine whether completion of academic semesters might be explained by attending cognitive remediation alongside supported education. At the end of the each semester, course instructors notified the research team as to whether participants had completed or not completed the academic semester. The unit of measure, 'course completed' refers to the completion of the required number of courses in that academic semester to progress through to the next semester.|The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)||||Courses completed||Standard Deviation|Mean
1376495|NCT01492426|Secondary|Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1a participants assessed for SVR12 response.|||Percentage of participants||95% Confidence Interval|Number
1376496|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)|SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.|Week 24 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR24 response.|||Percentage of participants||95% Confidence Interval|Number
1376497|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for cEVR response.|||percentage of participants||95% Confidence Interval|Number
1376498|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12|eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.|Week 4, Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for eRVR response.|||Percentage of participants||95% Confidence Interval|Number
1376499|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for RVR response.|||Percentage of participants||95% Confidence Interval|Number
1376500|NCT01492426|Primary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR12 response.|||Percentage of participants||95% Confidence Interval|Number
1376501|NCT01492400|Secondary|Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)|FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).|Baseline, Month 12|Intent-to-Treat: all randomized patients|||Square Millimeters (mm^2)||Standard Deviation|Mean
1376502|NCT01492400|Secondary|Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye|OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).|Baseline, Month 12|Intent-to-Treat: all randomized patients|||Microns||Standard Deviation|Mean
1376503|NCT01492400|Primary|Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 12 Months|Intent-to-Treat: all randomized patients|||Letters||Standard Deviation|Mean
1392949|NCT01329978|Secondary|Percentage of Participants With HCV RNA < LOD at Week 2||Week 2|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
1376504|NCT01492309|Secondary|Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)|We measured the levels of Brain Derived Neurotrophic Factor (BDNF) concentration across time. BDNF is a protein thought to regulate mood and cognitive functioning and research has suggested that levels may vary by severity of mood symptoms. We obtained BDNF values on test days 1 & 20.|Change in concentration from test day 1 to test day 20|Only 4 participants from both the active and sham TMS groups were used in analysis because these participants had BDNF data at both time points. Furthermore, some samples were deemed unusable.|||pg/mL||Standard Deviation|Mean
1376505|NCT01492309|Primary|Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment|We measured changes in Hamilton Rating Scale for Depression (HDRS-17) scores from baseline to post-treatment. The HDRS-17 was administered on test days 1, 10, & 20. Scoring is based on the 17-item scale and scores of 0–7 is generally accepted to be within the normal range, indicating minimal to no depression; scores of 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.|Change score from baseline to test day 20 (after 20 days of intervention)||||difference in units on a scale||Standard Deviation|Mean
1376506|NCT01492088|Secondary|Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)|Blood samples were collected and tested for MMAE plasma concentrations.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. n = number of participants analyzed at that given time-point. Data was summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm group."|||ng/mL||Standard Deviation|Mean
1376507|NCT01492088|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. n = number of participants analyzed at that given time-point. Data was summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm group."|||ug/mL||Standard Deviation|Mean
1376508|NCT01492088|Secondary|Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. n = number of participants analyzed at that given time-point. Data was summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm group."|||ug/mL||Standard Deviation|Mean
1376509|NCT01492088|Secondary|Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)|Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||participants|||Number
1376510|NCT01492088|Secondary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||participants|||Number
1376511|NCT01492088|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|From the first dose through 30 days after the last dose of study medication (up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||participants|||Number
1376512|NCT01492088|Secondary|Overall Survival (OS) (Phase 1 and 2)|OS is the time in months from start of study treatment to date of death due to any cause.|Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrollment of the last participant (Up to 60 months)|Safety population is defined as all participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
1376513|NCT01492088|Secondary|Progression Free Survival (PFS) (Phase 1 and 2)|PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.|||months||95% Confidence Interval|Median
1376514|NCT01492088|Secondary|Event Free Survival (EFS) (Phase 1 and 2)|EFS is defined as the time IN MONTHS from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.|||months||95% Confidence Interval|Median
1376515|NCT01492088|Secondary|Duration of Response (DOR) (Phase 1 and 2)|DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Participants with response from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. Duration of response was censored at last observation documenting absence of PD for participants who did not have tumor progression.|||months||95% Confidence Interval|Median
1376516|NCT01492088|Secondary|Time to Response (Phase 1 and 2)|Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.|||months||95% Confidence Interval|Median
1376517|NCT01492088|Secondary|Time to Progression (TTP) (Phase 1 and 2)|TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. TTP was censored on last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.|||months||95% Confidence Interval|Median
1376518|NCT01492088|Secondary|Overall Response Rate (ORR) (Phase 1)|Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Participants enrolled in Phase 1 of the study were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1376519|NCT01492088|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)|Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.|Baseline up to EOT (Up to 15 months)|Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.|||participants|||Number
1376520|NCT01492088|Primary|Overall Response Rate (ORR) (Phase 1 and 2)|Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||percentage of participants||95% Confidence Interval|Number
1376521|NCT01492088|Primary|Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)|Blood samples were collected and tested for MMAE plasma concentrations.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 21.||||||
1376522|NCT01492088|Primary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 20.||||||
1376624|NCT01491035|Primary|Cmax of Vortioxetine|Maximum plasma concentration of vortioxetine|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set = all patients who took at least one dose of IMP and who contributed with both Day 1 pre-dose pharmacokinetic sampling data and sufficient post-dose sampling data for estimation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Median
1376523|NCT01492088|Primary|Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 19.||||||
1376524|NCT01492088|Primary|Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)|Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.|||participants|||Number
1376525|NCT01492088|Primary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.|||participants|||Number
1376526|NCT01492088|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.|||participants|||Number
1376527|NCT01491984|Secondary|Time to Successful Intubation|Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.|intraoperative|||||||
1376528|NCT01491984|Secondary|Operator Rating of Difficulty|The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.|intraoperative|||||||
1376529|NCT01491984|Secondary|Number of Intubation Attempts|Number of intubation attempts was recorded after intubation was completed.|intraoperative|||||||
1376530|NCT01491984|Primary|Cormack-Lehane Grade|"The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale.~Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen"|intraoperative||||participants|||Number
1376531|NCT01491958|Secondary|Non Relapse Mortality (NRM) at One Year|Cumulative incidence of NRM will be calculated as the time from transplant until death not related to disease, where the competing risk for NRM was death due to disease. Patients who had not died were censored at last follow up.|up to 12 months post transplant||||percentage of patients||95% Confidence Interval|Number
1376532|NCT01491958|Secondary|Percentage of Patients With Chronic Graft Versus Host Disease (cGVHD)|cGVHD occurring anytime after day 100 post transplant will be termed chronic GVHD, and evaluated in patients who were followed for at least 100 days without early progression or death. Grading of cGVHD was done using the National Institutes of Health Consensus Development Project Criteria|up 1 year post transplant||||percentage of patients||95% Confidence Interval|Number
1376533|NCT01491958|Secondary|Time to Neutrophil and Platelet Engraftment|Neutrophil engraftment will be defined as first of three consecutive days with ANC ≥ 0.5 x 109/L post-conditioning regimen induced nadir. Similarly platelet engraftment is defined as first day of platelet count ≥ 20,000 x 109/L, without transfusion for 7 consecutive days.|weekly for 12 weeks, 100 days, 6 months, and 12 months||||days||Full Range|Median
1376534|NCT01491958|Secondary|Safety of Atorvastatin in Transplant Recipients in Terms of Adverse Events and Toxicities.|Adverse events and toxicities were monitored in patients using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.|Patients: Baseline, weekly for 9 weeks and then on days 84, 91-100, 180 and 365. Donors: at apheresis and then 30 days later.|Only patients with evaluable data reported|||patients|||Number
1376535|NCT01491958|Primary|Percentage of Participants With Grades II to IV aGVHD at Day +100 of Atorvastatin Administration|The incidence of grades II to IV aGVHD at day +100 of atorvastatin administration. The grading of aGVHD and cGVHD were done using the Consensus Conference criteria.|Up through day 100 following transplant||||percentage of patients||95% Confidence Interval|Number
1376536|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements (note: the participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40. The mean from the blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in diastolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).|||mmHg||Standard Deviation|Mean
1376625|NCT01491022|Secondary|Change in Stride Legth|change in stride length as measured by 3 D capture analysis|4 weeks||||meters||Standard Deviation|Mean
1376537|NCT01491919|Secondary|Change in Systolic Blood Pressure (BP) From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements. Note: these participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40 (inclusive). The mean of these blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in systolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).|||mmHg||Standard Deviation|Mean
1376538|NCT01491919|Secondary|Change in Systolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.~Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).~The mean from these measurements was calculated."|Baseline to Day 14 (+/- 3 days)|Change in systolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care (SOC) group which are reported separately).|||mmHg||Standard Deviation|Mean
1376539|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.~Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).~The mean of these measurements was calculated."|Baseline to Day 14 (+/-3 days)|Change in diastolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care group which are reported separately).|||mmHg||Standard Deviation|Mean
1376540|NCT01491919|Secondary|Change in Urine Protein/Creatinine From Baseline in Lisinopril-naive Participants.|Change in urine protein/creatinine obtained as follows: Mean change (worst post-dose from baseline) presented for urine protein/creatinine ratio. Geometric mean of the ratio (worst post-dose / baseline with Geometric Coefficient of Variation percent (CV%) and greatest decrease presented for eGFR by dose group. Two patients in the high dose group had an evaluable urine protein/creatinine change.|Baseline to worst post-dose before Day 14 (+/- 3 days)||||mg/mg||Geometric Coefficient of Variation|Geometric Mean
1376541|NCT01491919|Secondary|Largest eGFR Percent Decrease From Baseline in Lisinopril-naive Participants|"The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitor (ACEI) mediated reduction in kidney function.~Largest eGFR percent decrease from baseline reported in results section."|Baseline to Day 14 (+/- 3 days)||||percentage|||Number
1376542|NCT01491919|Primary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) During/After Study Drug Administration|Number of Adverse Events (AEs) related and not related to study drug; number of Serious Adverse Events (SAEs) related and not related to study drug|First dose of study drug to 30 days after final study visit for AEs and until resolution for SAEs||||events|||Number
1376543|NCT01491919|Primary|PK Renal Clearance (CLrenal)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CLrenal. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose.||||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
1376544|NCT01491919|Primary|PK - Oral Clearance (CL/F)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CL/F. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and at 1, 2, 4, 5, 8, 12, and 24 hrs after dose||||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
1376545|NCT01491919|Primary|PK - Time of the Maximum Observed Concentration in Plasma (Tmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of plasma lisinopril concentration. Medium was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose||||hours||Full Range|Median
1376546|NCT01491919|Secondary|Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants|The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitors (ACE-I)-mediated reduction in kidney function. eGFR ratio was computed from the worst post-dose value divided by the Baseline value.|Baseline to Day 14 (+/- 3 days)||||ratio||Geometric Coefficient of Variation|Geometric Mean
1376547|NCT01491919|Secondary|Change in Potassium Level From Baseline in Lisinopril-naive Participants|Potassium values will be obtained at Baseline and Day 14 prior to the final dose of study drug. Mean calculated from the two measurements.|At baseline visit and Day 14 prior to final study dose.||||mEq/L||Standard Deviation|Mean
1376548|NCT01491919|Primary|PK - Maximum Observed Concentration of Drug in Plasma (Cmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of Cmax. Geometric mean was calculated from all measurements.|Day14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1376549|NCT01491919|Primary|Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of AUC. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 days) of lisinopril therapy at hours 0 (pre-dose) and 1,2,4,5,8,12 and 24 hrs after dose||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1376550|NCT01491802|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Measurements of pulmonary function included spirometry and body plethysmography. Values reported are 90 minutes post-dose after 4 weeks of treatment.|4 weeks|14 subjects completed both treatments for comparison.|||L||Standard Deviation|Mean
1376551|NCT01491802|Secondary|Mean Expiratory Flow at Isotime Exercise|Mean expiratory flow was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.|||L/s||Standard Deviation|Mean
1376552|NCT01491802|Secondary|Tidal Esophageal Pressure (Pes) Swings at Isotime Exercise|Tidal esophageal pressure (Pes) swings were measured via an esophageal balloon catheter during constant work rate exercise tests. Tidal Pes expressed relative to maximum is an index of respiratory effort. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|Although 14 subjects completed both treatment arms for comparison, only 9 subjects also had complete measurements of EMGdi and respiratory pressures.|||percentage of maximum Pes||Standard Deviation|Mean
1376553|NCT01491802|Secondary|Diaphragm Electromyogram (EMGdi) at Isotime Exercise|EMGdi was measured during constant work rate exercise tests via a multipair-electrode esophageal catheter. EMGdi expressed as a percentage of its maximum is used as an index of inspiratory neural drive. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|Although 14 subjects completed both treatment arms, only 9 subjects had complete measurements of EMGdi and respiratory pressures.|||percentage of maximum EMGdi||Standard Deviation|Mean
1376554|NCT01491802|Secondary|Inspiratory Capacity at Isotime Exercise|Measurements of inspiratory capacity (IC) were conducted during constant work rate exercise tests. Isotime was defined as the highest time in minutes completed in both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.|||L||Standard Deviation|Mean
1376555|NCT01491802|Secondary|"Intensity of Unpleasantness of Breathing at Isotime Exercise"|"Intensity rating (modified 10-point Borg scale) measured at a standardized time (isotime) during constant work rate exercise tests. A rating of 0 represents no unpleasantness of breathing up to a maximum of 10. An improvement would be noted as a decrease in the Borg scale rating. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests."|4 weeks|Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.|||units on a scale||Standard Deviation|Mean
1376556|NCT01491802|Secondary|Ventilation at Isotime Exercise|Ventilation was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.|||L/min||Standard Deviation|Mean
1376557|NCT01491802|Secondary|Inspiratory Capacity at Rest|Measurements of pulmonary function included spirometry and body plethysmography. The resting inspiratory capacity (IC) values reported here are 90 minutes post-dose after 4 weeks of treatment.|4 weeks|14 subjects completed both treatments for comparison.|||L||Standard Deviation|Mean
1376558|NCT01491802|Secondary|Exercise Endurance Time|Duration of constant work rate cycle exercise at 75% of maximum|4 weeks||||minutes||Standard Deviation|Mean
1376559|NCT01491802|Primary|Exertional Dyspnea Intensity at Isotime Exercise.|Intensity of dyspnea (defined as breathing discomfort) at a standardized time (isotime) during constant work rate exercise tests as measured by the modified 10-point Borg scale. A rating of 0 represents no dyspnea up to a maximum of 10: a smaller rating is therefore an improvement. Isotime was defined as the highest exercise time in minutes completed in both post-treatment tests.|4 weeks|Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.|||units on a scale||Standard Deviation|Mean
1376560|NCT01491737|Secondary|Percentage of Participants With Any Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|Up to 49 months approximately|Safety population included all participants who had received at least 1 dose of any study medication assigned to treatment arms as treated.|||percentage of participants|||Number
1376561|NCT01491737|Secondary|Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Visual Analog Scale (VAS) Scores|EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, every 3 cycles (21-day cycle), and every 3 months after treatment discontinuation (up to 49 months, approximately)|ITT population included all randomized participants. Here, ‘n’ number of participants who were evaluated at specified time point.|||unit on a scale||Standard Deviation|Mean
1376562|NCT01491737|Secondary|Clinical Benefit Response (CBR)|CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed is the participants with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
1376563|NCT01491737|Secondary|Objective Overall Response Rate (ORR)|ORR was defined as participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who had measureable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
1376626|NCT01491022|Secondary|Timed 25-foot Walk Test (T25FW)|time required to perform T25FW.|4 weeks||||seconds||Standard Error|Mean
1376564|NCT01491737|Secondary|Time to Response (TTR)|TTR was defined as the time from the date of randomization to the date of first CR or PR. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A censored time to response was calculated at the date of the last adequate tumor assessment as there was no date of confirmed response (CR or PR). If no tumor assessment is performed for the participant (or all post-baseline assessments are not evaluable or PD) the censoring day would be set to day 1 (date of randomization).|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.|||months||95% Confidence Interval|Median
1376565|NCT01491737|Secondary|Duration of Response (DOR)|DOR was defined as the period from the date of initial confirmed partial response (PR) or complete response (CR) until the date of progressive disease or death from any cause. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with no documented progression after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.|||months||95% Confidence Interval|Median
1376566|NCT01491737|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication (pertuzumab, trastuzumab, AI or induction chemotherapy), and participants with no post-baseline information were censored at the date of randomization.|From the date of randomization until first documented death (approximately, up to 49 months)|ITT population included all randomized participants.|||Months||95% Confidence Interval|Median
1376567|NCT01491737|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the response evaluation criteria in solid tumors (RECIST) (version 1.1). Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression). Participants with no PFS events were censored at the time of the last evaluable tumor assessment.|Baseline to progressive disease or death (approximately, up to 49 months)|ITT population included all randomized participants.|||months||95% Confidence Interval|Median
1376568|NCT01491672|Secondary|Duration of Response (DoR)|DoR was defined as the time from the first occurrence of PR or CR (as per local radiological review) until the date of the first documented disease progression or death due to underlying cancer.|20 months|The FAS was considered for this analysis. The FAS included all enrolled participants. Only participants who achieved a CR or PR were analyzed. Therefore, actual n=4,3,3,10.|||months||95% Confidence Interval|Median
1376569|NCT01491672|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants with best overall response of CR or PR based on the local radiological data according to the RECIST 1.0 Criteria|20 months|The FAS was used. It included all enrolled participants.|||Participants|||Number
1376570|NCT01491672|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease based on the local radiological data according to the RECIST 1.0 criteria.|20 months|The FAS was used. It included all enrolled participants.|||Participants|||Number
1376571|NCT01491672|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause.|28 months|The FAS was used. It included all enrolled participants.|||months||95% Confidence Interval|Median
1376572|NCT01491672|Secondary|Duration of PFS for Each First-line Treatment Cohort|Duration of PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. Participants' assessment was based on the local radiological data according to the RECIST 1.0 Criteria.|20 months|The FAS was used. It included all enrolled participants.|||months||95% Confidence Interval|Median
1376573|NCT01491672|Primary|Progression-free Survival (PFS) - All Participants|PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. The primary analysis of PFS was based on a local radiology review of CT scans and MRI collected until the participant experienced disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.|20 months|The full analysis set (FAS) was used. It included all enrolled participants.|||months||95% Confidence Interval|Median
1376574|NCT01491633|Post-Hoc|Time on Study|Number of days participant remained on study|2 years||||days||Standard Deviation|Mean
1376575|NCT01491633|Secondary|Toxicities|Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.|2 years||||grade 3 toxicities|||Number
1376576|NCT01491633|Secondary|Survival|Establish the overall survival of patients with SCC treated with dasatinib|2 years|One subject who was alive at the end of the study was censored from the survival analysis|||days||Standard Deviation|Mean
1376577|NCT01491633|Secondary|Types and Frequency of DDR2 Mutations|Determine frequency of DDR2 mutations in study patients|2 years||||participants|||Number
1376578|NCT01491633|Primary|Response Rate|Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib|2 years||||percent|||Number
1376627|NCT01491022|Secondary|Timed Up and Go (TUG) Score|time required to perform TUG.|4 weeks||||seconds||Standard Error|Mean
1376628|NCT01491022|Secondary|Freezing of Gait Questionnaire (FOGQ)|change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired|4 weeks||||units on a scale||Standard Deviation|Mean
1376579|NCT01491607|Secondary|Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||percentage of participants|||Number
1376580|NCT01491607|Secondary|Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||participants|||Number
1376581|NCT01491607|Secondary|Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||percentage of participants|||Number
1376582|NCT01491607|Secondary|Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||participants|||Number
1376583|NCT01491607|Secondary|Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Days 63 to 100|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive.|||percentage of participants||95% Confidence Interval|Mean
1376584|NCT01491607|Secondary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 70 +/- 2 days|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days.|||percentage of participants||95% Confidence Interval|Least Squares Mean
1376585|NCT01491607|Primary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 63 +/- 2 days|Subjects who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.|||percentage of participants||95% Confidence Interval|Mean
1376586|NCT01491490|Primary|Change in Bodyweight.|Efficacy of a 40:1 ratio of GWP42003:GWP42004 compared with placebo in the change from baseline in body weight after 42 days (6 weeks) in subjects currently being treated with olanzapine for schizophrenia or other non-affective psychosis.|6 weeks from Baseline.||||Kg|||Number
1376587|NCT01491178|Secondary|Incidences of Stroke and Systemic Embolism (SEE)|Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.|Up to 104 weeks from first administration of study drug|Effectiveness set: This analysis set included all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa, contraindication and / or who did not suffer from NVAF.|||Number of patients per 100 patient year||95% Confidence Interval|Number
1376588|NCT01491178|Primary|Frequency (Percentage) of Participants With Adverse Drug Reactions|Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as “Related”, “Probably related”, or “Cannot be denied”.|Up to 104 weeks from first administration of study drug|Safety set: This patient set includes all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa.|||Percentage of participants|||Number
1376589|NCT01491113|Secondary|Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated according: CLHD=CLD+CLUF.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1376590|NCT01491113|Secondary|Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1376591|NCT01491113|Secondary|Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1376592|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period|tmax refers to the time to reach maximum plasma concentration (tmax).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
1376593|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
1376594|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 140 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Full Range|Median
1376595|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period|tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
1376596|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L057 for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
1376597|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Full Range|Median
1376598|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D|"tmax refers to the time to reach maximum plasma concentration (tmax).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
1376629|NCT01491022|Secondary|United Parkinson's Disease Rating Scale Score(UPDRS) ,|change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.|4 weeks||||units on a scale||Standard Error|Mean
1376630|NCT01491022|Primary|Change in Velocity|The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.|baseline and 4 weeks||||m/s||Standard Deviation|Mean
1376599|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Geometric Coefficient of Variation|Geometric Mean
1376600|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376601|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D|"tmax refers to the time to reach maximum plasma concentration of ucb L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
1376602|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Geometric mean and Coefficient of Variation (CV) was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Full Range|Median
1376603|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L057 for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1376604|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D|"Ae refers to the total amount of ucb L057 excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mg||Geometric Coefficient of Variation|Geometric Mean
1376605|NCT01491113|Secondary|Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D|"The Non-Renal Clearance (CLNR) describes the removal of drug by organs other than the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1376606|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1376607|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1376608|NCT01491113|Secondary|Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D|"fe refers to the fraction of dose excreted in urine of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||Percentage of Dose Administered||Geometric Coefficient of Variation|Geometric Mean
1376631|NCT01490931|Primary|Comparison of Pain Intensity Scores at 6 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||6 Hours post-dose||||millimeters||Standard Error|Mean
1376609|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D|"Ae refers to the total amount of ucb L059 (Levetiracetam) excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mg||Geometric Coefficient of Variation|Geometric Mean
1376610|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376611|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L057.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376612|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376613|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376614|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376615|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D|"Cmax refers to the maximum observed concentration of ucb L057.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376616|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376617|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D|"Cmax refers to the maximum observed concentration of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1376618|NCT01491035|Primary|Oral Clearance (CL/F) of Vortioxetine|Oral clearance expressed as a function of bioavailability|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||L/h||Standard Deviation|Median
1376619|NCT01491035|Primary|t½ of Lu AA34443|Half-life of the major, inactive metabolite Lu AA34443 in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||h||Standard Deviation|Median
1376620|NCT01491035|Primary|AUC(0-24h) of Lu AA34443|Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||ng*h/mL||Standard Deviation|Median
1376621|NCT01491035|Primary|Cmax of Lu AA34443|Maximum plasma concentration of the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set|||ng/mL||Standard Deviation|Median
1376622|NCT01491035|Primary|t½ of Vortioxetine|Half-life of vortioxetine in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||h||Standard Deviation|Median
1376639|NCT01490931|Secondary|Median Onset of Meaningful Pain Relief|Measure obtained using recognized double-stop watch technique. Patient is asked to depress the second stop watch when pain relief is meaningful to them. Each patient decides what meaningful relief is for them.|At time of depressing meaningful relief stopwatch up to 6 hours.||||seconds||95% Confidence Interval|Median
1376640|NCT01490931|Secondary|Most Frequent Number of Days of Analgesic Dosing in Dental Implant Surgery Patients When Employing Intranasal Ketorolac as Their Pain Medication.|Self explanatory|Up to 5 days||||days|||Number
1376641|NCT01490931|Secondary|Percentage of Subjects Who Reach a Level of at Least Moderate Pain by Achieving a Score of at Least 40 mm on a 100 mm Visual Analog Scale Within 5 Hours After the Completion of Surgery.||Up to 5 hours after last suture is placed|All subjects (regardless of pain intensity) receiving one to three dental implants|||percentage of participants|||Number
1376642|NCT01490931|Primary|Comparison of Pain Intensity Scores at 20 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale|20 minutes post dose||||millimeters||Standard Error|Mean
1376643|NCT01490931|Secondary|The Median Onset of First Perceptible Pain Relief of Intranasal Ketorolac in Dental Implant Surgery Patients|Data will be obtained employing the well-described double stop watch technique|Censored at 6 hours||||seconds||95% Confidence Interval|Median
1376644|NCT01490866|Secondary|Frequency of Adverse Events as a Measure of Safety|The frequency of adverse events (AEs) was analyzed in 2 groups of patients, those receiving FOLFOX/bevacizumab (N=70), and patients who received axitinib maintenance (N = 48). AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.||||participants|||Number
1376645|NCT01490866|Secondary|Overall Survival (OS)|Defined as the time from first treatment until death from any cause.|every 8 weeks until progression then every 3 months for up to 5 years.||||months||95% Confidence Interval|Median
1376646|NCT01490866|Secondary|Time To Progression (TTP)|Defined as the time after a disease is diagnosed (or treated) until worsening of the disease.|every 8 weeks, assessed approximately up to 24 months||||months||95% Confidence Interval|Median
1376647|NCT01490866|Secondary|Objective Response Rate|Defined as the percentage of evaluable patients showing a complete or partial response (CR or PR) per RECIST v1.1 criteria. CR = disappearance of all lesions. PR = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks, assessed up to approximately 24 months||||percentage of participants|||Number
1376648|NCT01490866|Primary|Progression-free Survival|Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.|24 months|All patients who received at least one dose of any study drug.|||months||95% Confidence Interval|Median
1376649|NCT01490840|Secondary|Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A positive change from baseline indicates improvement.|Baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.|||L/s||95% Confidence Interval|Least Squares Mean
1376650|NCT01490840|Secondary|Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||[ml/min/kg][watt/kg body weight]||95% Confidence Interval|Least Squares Mean
1376651|NCT01490840|Secondary|Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory Second Edition (BDI-II) is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders Fourth Edition. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II. There is a four-point scale for each item ranging from 0 to 3. The total score ranges from 0 - 63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
1376652|NCT01490840|Secondary|Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)|The WEIMuS (Würzburg Fatigue Inventory for MS) scale is a validated self-assessment instrument to quantify the degree of fatigue. The scale consists of 17 items with 5 categories that are scored from ‘0’ to ‘4’. The subscores for cognitive and physical fatigue range from 0 to 36 and from 0 to 32, respectively, with the total sum score ranging from 0 to 68; higher scores indicate higher degrees of fatigue. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
1376691|NCT01490359|Secondary|Frequency of Condom Use in the Past 3 Months|Respondents' rating on a 5-point scale from 1 (never) to 5 (always) how often they used a condom during vaginal intercourse. Measured separately for steady and casual partners.|Baseline, 6 months, 12 months post intervention|Participants with data from baseline and at least one post-intervention assessment.|||units on a scale||Standard Error|Mean
1376991|NCT01487577|Primary|Number of Participants With Acute Grade II-IV GVHD, Acute Grade III-IV GVHD, and Chronic GVHD.|Acute GVHD will be graded according to the Modified Glucksberg Staging Criteria. Chronic GVHD will be graded according to NIH Chronic GVHD Consensus Guidelines.|1 year||||participants|||Number
1376653|NCT01490840|Secondary|Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)|The Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) consists of 44 items, 28 of which are the basis for computation of five subscale scores reflecting major dimensions of health-related quality of life (HRQoL) in MS: Fatigue/Thinking (4 items), Mobility lower limb (5 items), Mobility upper limb (5 items), Social function (6 items) and Mood (eight items). Subscales and total score range from 1 to 5, with high scores indicating a lower quality of life. In this study, the total score and following 3 subscales: fatigue/thinking, mobility lower limb and mobility upper limb only were analyzed. A negative change from baseline indicates improvement.|Baseline, 6 months, 12 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
1376654|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).~Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||joule||95% Confidence Interval|Least Squares Mean
1376655|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).~Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||newton meter||95% Confidence Interval|Least Squares Mean
1376656|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test|The Sit to Stand Test is a functional outcome measure of the lower-extremity muscle power. The test was performed 3 times with one minute rest in between. The best attempt out of three was used for the analysis. A positive change from baseline indicates improvement.|baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.|||watt/kilogram body weight||95% Confidence Interval|Least Squares Mean
1376657|NCT01490840|Primary|Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).|The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
1376658|NCT01490697|Secondary|Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score|IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 14 IES-R total score from the Day 7 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.|Day 7 (Baseline) and Day 14|All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.|||score on a scale||Standard Deviation|Mean
1376659|NCT01490697|Primary|Physiological Posttraumatic Stress Disorder (PTSD) Probability as Determined From Psychophysiologic Responses to Traumatic Recollection|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses to script-driven imagery of traumatic events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator electromyogram (EMG) responses of the left lateral frontalis facial muscle in microVolts. Responses for the traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant's posterior probability of being classified as PTSD.|1 week following treatment (Day 14)|All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.|||percent probability||Standard Deviation|Mean
1376660|NCT01490684|Secondary|Length of Stay in the Hospital|Patients will be followed for up to 180 days.Patinets alive in the hospital beyond 180 days of stay will have a hospital length of stay of 180 days.|date of discharge from hospital minus date of admission to hospital||||days||Standard Deviation|Mean
1376661|NCT01490684|Secondary|Length of Stay in the ICU|Patients will be followed for up to 180 days.Patinets alive in the ICU beyond 180 days of stay will have an ICU length of stay of 180 days.|date of discharge from ICU minus date of admission to ICU||||days||Standard Deviation|Mean
1376662|NCT01490684|Secondary|Duration of Mechanical Ventilation|If multiple intubations in the same admission, then the durations of mechanical ventilation will be added.This will be assessed for up to 180 days of stay in the ICU.|date of extubtation minus date of intubation|||||||
1376663|NCT01490684|Secondary|ICU Mortality|If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.|patients will be followed until discharge from the hospital and vital status at discharge from the hospital will be noted (expected hospital stay is 5 weeks). Hopsital mortality will be censored at 180 days after entry into the study.||||Participants|||Count of Participants
1376664|NCT01490684|Primary|Hospital Mortality|For patients staying in the ICU for long periods, hospital mortality will be censored at 180 days after entry into the study.That is patient staying alive in the hospital more than 180 days will be considered alive.|Patients will be followed while in the ICU and the vital status at the time of discharge from the ICU will be noted. The expected stay in the ICU is 10 days on average.||||Participants|||Count of Participants
1376992|NCT01487577|Primary|Number of Participants With Grade ≥3 Toxicities Scored According to the CTCAE Version 4.0.||100 days||||participants|||Number
1376665|NCT01490632|Secondary|PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)||Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse|All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part A, B or C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.|||nanomole*hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
1376666|NCT01490632|Secondary|Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib||Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse|All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.|||nanomole (nM)||Geometric Coefficient of Variation|Geometric Mean
1376667|NCT01490632|Secondary|Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C|Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score >125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.|Week 40|All randomized participants who received ≥1 dose of study drug in Part A and participated in Part C.|||Percentage of Participants|||Number
1376668|NCT01490632|Secondary|Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome."|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||mm||Standard Deviation|Mean
1376669|NCT01490632|Secondary|Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome."|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.|||mm||Standard Deviation|Mean
1376670|NCT01490632|Secondary|Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.|||Millimeter (mm)||Standard Error|Least Squares Mean
1376671|NCT01490632|Secondary|Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92|The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
1376672|NCT01490632|Secondary|Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24|The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. As observed values were used.|||Units on a Scale||Standard Deviation|Mean
1376692|NCT01490359|Secondary|Self-reported Condom Use at Most Recent Vaginal Intercourse|The respondents' self-report of using a condom during their most recent vaginal intercourse. Calculated separately for steady and casual partners.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
1376673|NCT01490632|Secondary|Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12|The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1376674|NCT01490632|Secondary|Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92|The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
1376675|NCT01490632|Secondary|Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24|The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
1376676|NCT01490632|Secondary|Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12|The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing “no itch” and 10 representing “worst itch imaginable.” Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1376677|NCT01490632|Secondary|Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant."|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
1376678|NCT01490632|Secondary|Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant."|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part B and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
1376679|NCT01490632|Secondary|Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1376680|NCT01490632|Secondary|Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug and has 1 post-baseline observation at or prior to week 92. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
1376761|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring at Any Time|Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376681|NCT01490632|Secondary|Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.|Baseline Part A, Week 24|All randomized participants who received at least one dose of study drug and at least 1 post-baseline observation in Part A at or prior to week 24. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
1376682|NCT01490632|Secondary|Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.|Baseline Part A, Week 12|All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
1376683|NCT01490632|Secondary|Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 92|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.|||Percent of Participants|||Number
1376684|NCT01490632|Secondary|Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 24|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.|||Percent of Participants|||Number
1376685|NCT01490632|Secondary|Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 12|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.|||Percent of Participants|||Number
1376686|NCT01490632|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.|Week 12|North American (NA) modified intent-to-treat (mITT) population: All NA randomized participants who received at least one dose of study drug. Non-responders and participants who discontinued study drug any time prior to time point of interest, or discontinued from study, were defined as non-responders for the non-responder imputation (NRI) analysis.|||Percent of Participants|||Number
1376687|NCT01490359|Secondary|Multiple Vaginal Partners in the Past 3 Months|The report of having vaginal intercourse with 2 or more women in the past 3 months.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
1376688|NCT01490359|Secondary|Heterosexual Anal Intercourse in the Past 3 Months|The report of having anal intercourse with a woman in the past 3 months|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
1376689|NCT01490359|Secondary|Condomless Vaginal Intercourse in the Past 3 Months|A binary variable indicating whether participant reported having vaginal intercourse without using a condom in the past 3 months (0 = did not have vaginal intercourse or always used a condom; 1= did have vaginal intercourse without using a condom)|Baseline, 6 months, and 12 months post-intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
1376690|NCT01490359|Secondary|Talked to Partner About Condom Use|A binary variable indicating whether the participants talked to partner about using condoms in the past 90 days.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
1381367|NCT01445626|Primary|Time to OZURDEX® Re-injection|Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.|Up to 12 months|All participants with data available for analysis.|||Days||Standard Deviation|Mean
1376693|NCT01490359|Secondary|The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months|The proportion of condom-protected acts of vaginal intercourse is defined as the self-reported number of acts of vaginal intercourse in which the respondent used a condom in the past 3 months divided by the total number of acts of vaginal intercourse the respondent reported in the past 3 months. Calculated separately for steady and casual partners.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||proportion of acts||Standard Error|Mean
1376694|NCT01490359|Primary|Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months|Men who reported at least 1 vaginal intercourse act in the past 3 months and whose number of reported condom-protected vaginal intercourse acts equaled their number of vaginal intercourse acts were coded as practicing consistent or 100% condom use. Men who reported at least 1 vaginal intercourse act and whose reported number of condom-protected vaginal intercourse acts was less than their number of vaginal intercourse acts were coded as not practicing consistent condom use. Separate binary variables reflected consistent condom use with primary partners and casual partners.|Baseline, 6 months, 12 months post-intervention|Participants with data at baseline and at least one follow-up.|||Participants|||Count of Participants
1376695|NCT01490294|Secondary|Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)||Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in FAS with assessment for this outcome measure. Evaluation included all participants in the full analysis population with an assessment for this outcome measure|||Percentage of participants|||Number
1376696|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure|||Percent segmental assessment|Participants||Number
1376697|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|PPS. Evaluation included all participants in the per protocol population with an assessment for this outcome measure|||Percent segmental assessment|Participants||Number
1376698|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent regional assessment|Participants||Number
1376699|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent segmental assessment|Participants||Number
1376700|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent segmental assessment|Participants||Number
1376701|NCT01490294|Secondary|Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent regional assessments|Participants||Number
1376702|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
1376796|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist|Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.|8 months||||percentage of participants||95% Confidence Interval|Number
1376703|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
1376704|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
1376705|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
1376706|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment|||Participants|||Number
1376707|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
1376708|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
1376709|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
1376710|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
1376711|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
1376712|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
1376713|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
1376714|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
1376715|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
1376716|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
1376717|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. The evaluation included only participants with delayed enhancement in at least 1 segment ( PPS) based on the assessment of at least one blinded reader.|||Delayed enhancement assessments|Participants||Number
1376718|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement (DE)-[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessment|Participants||Number
1376719|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
1376720|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
1376721|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."|||Percent regional assessments|Participants||Number
1376722|NCT01490294|Secondary|Time to Peak Based on Segments|"Time to peak is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes|PPS|||Seconds||Standard Deviation|Mean
1376797|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist|Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.|8 months||||percentage of participants||95% Confidence Interval|Number
1376723|NCT01490294|Secondary|Upslope Based on Segments|"Upslope is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in Units/sec. The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Units/sec||Standard Deviation|Mean
1376724|NCT01490294|Secondary|Signal Intensity (SIrel) Based on Segments|"The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Signal intensity||Standard Deviation|Mean
1376725|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
1376726|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
1376727|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
1376728|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
1376729|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions|For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure|||Percent regional assessments|Participants||Number
1376730|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI)  (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)"|MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI <=1.5 (perfusion defect) and >1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of >70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure|||Percent regional assessments|Participants||Number
1376731|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of > 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure|||Percent regional assessments|Participants||Number
1376732|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments|Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percentage of segments with artifacts|Participants||Number
1376733|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments|Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percentage of segments with artifacts|Participants||Number
1376734|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
1376735|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
1376736|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
1376737|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
1376738|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessment|Participants||Number
1376739|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
1376740|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
1376741|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia. The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
1376742|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."|||Percent segmental assessment|Participants||Number
1376743|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia.The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
1376744|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
1376745|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of scar. The number of regional assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
1376746|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
1376747|NCT01490294|Secondary|Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
1376748|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
1376749|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
1376750|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)|||Percent segmental assessment|Participants||Number
1376751|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent [LAD], left circumflex [LCX], right coronary artery [RCA]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)|||Percent regional assessments|Participants||Number
1376752|NCT01490190|Secondary|Number of Participants Who Reported a Serious Adverse Event During the Study|A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
1376753|NCT01490190|Secondary|Number of Participants Who Reported at Least One Adverse Event During the Study|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
1376754|NCT01490190|Secondary|Number of Pregnancies Due to Contraceptive Method Failure During the Study|For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Pregnancies|||Number
1376755|NCT01490190|Primary|Number of Participants Who Would Recommend Vaginal Ring to Others|Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
1376756|NCT01490190|Primary|Number of Participants Who Plan to Continue Using Vaginal Ring|Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
1376757|NCT01490190|Primary|Participants' Overall Satisfaction With Vaginal Ring|Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
1376758|NCT01490190|Primary|Frequency of Partner Objecting to Vaginal Ring Use|Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376759|NCT01490190|Primary|Frequency of Partner Feeling Vaginal Ring During Intercourse|Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376760|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring During Intercourse|Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376762|NCT01490190|Primary|Participants' Assessment of Ease of Removal of Vaginal Ring|Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376763|NCT01490190|Primary|Participants' Assessment of Ease of Insertion of Vaginal Ring|Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376764|NCT01490190|Primary|Number of Spotting Days Per Cycle|Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Participants in the Per Protocol Population who experienced spotting were evaluated for duration of spotting.|||Days||Standard Deviation|Mean
1376765|NCT01490190|Primary|Number of Bleeding Days Per Cycle|Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.|Up to 84 days (three 28-day cycles)|One participant in Per Protocol Population who experienced vaginal bleeding was evaluated for duration of bleeding.|||Days||Standard Deviation|Mean
1376766|NCT01490190|Primary|Number of Participants With Intermenstrual Bleeding/Spotting|Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376767|NCT01490190|Primary|Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring|Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.|||Pads||Full Range|Median
1376768|NCT01490190|Primary|Average Number of Bleeding Days Per Cycle|Mean duration of menstruation, per day, per cycle, during the study period.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.|||Days||Standard Deviation|Mean
1376769|NCT01490190|Primary|Number of Participants With Regular Menstrual Cycles|The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
1376770|NCT01490151|Primary|Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions|A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.|Day of hospital admission (12 hours)|A total of 25 admissions were completed. 1 participant was admitted twice in Cohort A1, and 2 participants were admitted first in Cohort A1 and then again in Cohort B.|||Admissions|Admissions||Count of Units
1376771|NCT01490125|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment|The number of puffs of rescue medication taken by participants, were collected each day during the study via entries in e-diaries|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||puffs||Standard Deviation|Least Squares Mean
1376772|NCT01490125|Secondary|Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment|The Capacity of Daily Living during the Morning (CDLM) is a self-administered daily assessment. The CDLM asks COPD patients to (i) report their ability to carry out 6 morning activities and (ii) rate the difficulty in performing those activities on a five point Likert-type scale ranging from “not at all difficult” to “extremely difficult”. For each of the six morning activities a score ranging from 0 (=so difficult that they could not carry out the activity by themselves) to 5 (not at all difficult to carry out the activity by themselves) is calculated by using the responses from the two questions for each activity. Daily CDLM is calculated using the scores average from the 6 morning activities. CDLM is calculated as the average daily CDLM score over 6 weeks of treatment. The change from baseline in CDLM score over 6 weeks is analyzed using a MIXED model with baseline CDLM score as a covariate. A CDLM score of 0.20 is considered to be a minimal clinically important difference.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Units on a scale||Standard Error|Least Squares Mean
1376773|NCT01490125|Secondary|Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Vital Capacity (FVC) is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC was measured via spirometry conducted according to internationally accepted standards at 5 min-4 hr post dose of day 1 and week 6.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Liters||Standard Error|Least Squares Mean
1376774|NCT01490125|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Expiratory Volume in 1 second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were taken at 5 min- 4hr post-dose of day 1 and week 6. The standardized FEV1 Area under the curve (AUC) was calculated as the sum of trapezoids divided by the length of time.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Liters||Standard Error|Least Squares Mean
1376775|NCT01490125|Secondary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Units on a scale||Standard Deviation|Mean
1376776|NCT01490125|Primary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Units on a scale||Standard Deviation|Mean
1376777|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale|The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
1376778|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale|The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had receiving at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
1376779|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale|The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
1376780|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale – Severity (CGI-S)|Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
1376828|NCT01489358|Primary|Number of Subjects With an Any Abnormal Laboratory Result|Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44|44 weeks after first vaccination|All subjects who received at least one vaccination|||participants|||Number
1376781|NCT01490086|Primary|Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
1376782|NCT01490060|Primary|Complete Response|Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.|From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).|Out of 40 eligible participants, 2 participants had change of treatment, 1 participant was noncompliant and 1 participant had an adverse event related to chemotherapy. 36 participants completed cycle 1 and cycle 2.|||percentage of participants|||Number
1376783|NCT01489969|Other Pre-specified|Duration of Wake After Sleep Onset (WASO)|The secondary efficacy parameter is the duration of wake after sleep onset (WASO) measured by the PSG after 28 nights of the double blind treatment period. WASO was summarized at baseline and after 28 days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the 28 nights was compared, adjusting for the baseline score. An ANCOVA model was used. Lower score indicates less waking time and thus considered improvement.|28 days||||minutes||Standard Deviation|Mean
1376784|NCT01489969|Other Pre-specified|Number of Awakenings (NOA)|The secondary efficacy parameter is number of awakenings (NOA) measured by the PSG after 28 nights of the double blind treatment period. NOA was summarized at baseline and after 28 days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the 28 nights was compared, adjusting for the baseline score. An ANCOVA model was used. Lower score indicates less awakenings and thus considered improvement.|28 days||||Awekenings||Standard Deviation|Mean
1376785|NCT01489969|Primary|Latency to Persistent Sleep|The primary efficacy parameter is Latency to persistent sleep (LPS) measured by the PSG at the first two nights (immediate effect) of the double blind treatment period. LPS was summarized at baseline and after two days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the two days was compared, adjusting for the baselinescore. An ANCOVA model was used. Lower score indicates reduction in latency to persistent sleep and thus considered improvement|2 days||||minutes||Standard Deviation|Mean
1376786|NCT01489956|Secondary|Compare the Level of KLH-specific Antibodies in the Serum (Samples From Various Time Points) Between Parts A and B|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.||||||
1376787|NCT01489956|Secondary|Other Mechanistic Assessments on Archived Serum Samples Like Anti-KLH Antibodies and Secreted Cytokines (Part B)|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.||||||
1376788|NCT01489956|Secondary|Suppression (or Non-activation) of T Cell Stimulation Index Measured by CFSE Staining After KLH Stimulation (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.||||||
1376789|NCT01489956|Secondary|Suppression (or Non-activation) of Cytokine Secretion Profile of T Cells Stimulated by KLH Following Oral Feeding (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.||||||
1376790|NCT01489956|Secondary|T Cell Stimulation Index Measured by Carboxyfluorescein Diacetate Succinimidyl Ester (CFSE) Staining After KLH Stimulation (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.||||||
1376791|NCT01489956|Secondary|Cytokine Secretion Profile of T Cells Stimulated by KLH (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.||||||
1376792|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses.|Day 16|Data were not collected and therefore no analyses could be performed.||||||
1376793|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses|Day 9|Data were not collected and therefore no analyses could be performed.||||||
1376794|NCT01489956|Primary|Participants Demonstrating Tolerance to KLH Using T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part B)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI <3 on Day 32 indicated tolerance to KLH. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 32|Intent-to-treat|||participants|||Number
1376795|NCT01489956|Primary|Participants With a Positive Immune Response to T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI ≥3 on day 16 will indicate the presence of immune response. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 16|Intent-to-treat|||participants|||Number
1376798|NCT01489891|Secondary|Percentage of Participants With Adverse Events in Both Groups|Hypoxemia (SatO2<90% or >4% if the baseline was under 93%), bradycardia (<60 bpm or >10% from baseline), hypotension (systolic blood pressure under 90 mmHg and/or diastolic 60 mmHg), anaphylactic reaction, aspiration o methaemoglobinemia.|Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure||||percentage of participants||95% Confidence Interval|Number
1376799|NCT01489891|Primary|Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy|The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).|8 months||||mcg/kg/min||Standard Deviation|Mean
1376800|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 8|Mean Cmax of Cremophor on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL/mL||Geometric Coefficient of Variation|Geometric Mean
1376801|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 1|Mean Cmax of Cremophor on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL/mL||Geometric Coefficient of Variation|Geometric Mean
1376802|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 8|Mean Cmax of Dexanabinol on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1376803|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 8|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
1376804|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 1|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
1376805|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 8|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1376806|NCT01489826|Secondary|Progression Free Survival|Tumour response evaluation using RECIST 1.1. (Assessment by CT scan or MRI).|At Screening and after every 2 cycles of treatment (+/-1 week)|Patients included in this analysis were from the 'Efficacy population', defined as those with a baseline and at least one post-baseline assessment of efficacy.|||Days||Inter-Quartile Range|Median
1376807|NCT01489826|Secondary|Number of Adverse Events (AEs)|AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials|30 +/-3 days from the end of the last infusion|The numbers represent the total number of AEs per group. Refer to AE tables for specific information.|||Events|||Number
1376808|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 1|Mean Cmax of Dexanabinol on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1376809|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 1|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1376857|NCT01488994|Secondary|Safety: Number of Participants With Thrombotic Events||Throughout study period (approximately 17 months)||||Participants|||Number
1376858|NCT01488994|Secondary|Safety: Number of Participants With Severe Allergic Reactions, e.g. Anaphylaxis||Throughout study period (approximately 17 months)||||Participants|||Number
1392950|NCT01329978|Secondary|Change in HCV RNA at Week 12||Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1376810|NCT01489826|Primary|Number of Patients Experiencing Dose Limiting Toxicity (DLT)|"Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD).~3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no DLT has occurred. Upon occurrence of the first DLT within a cohort, an additional 3 patients were to be added to that cohort. For a six patient cohort, all 6 patients were to have completed their first dexanabinol treatment cycle with no more than 1 DLT before dose escalation to the next cohort. If 2 or more DLTs occur in a cohort, the next lower dose level will be declared the MTD.~DLTs will be graded for severity based on the National Cancer Institute (NCI) Common Terminology Criteria version 4.03."|Each patient will be followed for 22 days|Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the MTD (highest dose it is safe to give patients) or alternatively the Maximum Administered Dose(MAD). DLT evaluation in 3 to 6 patients at end of 1 treatment cycle|||Number of patients with DLT|||Number
1376811|NCT01489670|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.|Week 12|All participants with complete data available for IOP.|||mm Hg||Full Range|Median
1376812|NCT01489670|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|Week 12|All participants with data available for this outcome measure.|||Participants|||Number
1376813|NCT01489670|Secondary|Physician Reported Reasons for Early Discontinuation of Treatment|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 Weeks|All participants who discontinued treatment early.|||Participants|||Number
1376814|NCT01489670|Secondary|Physician Evaluation of Tolerability of Treatment|The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.|Week 12|All participants with data available for this outcome measure.|||Participants|||Number
1376815|NCT01489670|Secondary|Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.|||Participants|||Number
1376816|NCT01489670|Secondary|Physician Evaluation of Efficacy Using a 5-Point Scale|The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.|||Participants|Participants||Number
1376817|NCT01489670|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All participants with complete data available for IOP.|||mm Hg||Full Range|Median
1376818|NCT01489527|Secondary|Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58|The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.|18 Months|All treated participants|||percentage of participants|||Number
1376819|NCT01489527|Secondary|Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18|Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.|18 Months|Participants who were randomized to Gardasil and received all 3 doses of Gardasil|||percentage of participants|||Number
1376820|NCT01489527|Secondary|Percentage of Participants Who Were Seropositive by HPV Type|Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.|At Enrollment - 5 Month Enrollment Period|All treated participants|||percentage of participants|||Number
1376821|NCT01489527|Secondary|Study Compliance Rate|Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.|18 Months|All treated participants|||percentage of participants|||Number
1376822|NCT01489527|Primary|Human Papillomavirus (HPV) Rate|HPV type distribution and prevalence of each HPV type at enrollment.|At Enrollment - 5 Month Enrollment Period|All treated participants|||participants|||Number
1376823|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|24 weeks after the first vaccination|All subjects who received at least one vaccination|||titre||95% Confidence Interval|Geometric Mean
1376824|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|Pre-vaccination (Week 0)|All subjects who received at least one vaccination|||titre||95% Confidence Interval|Geometric Mean
1376825|NCT01489358|Secondary|Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)|ELISA titer (strain 37997) For ELISA, week 0 values were used to background correct titres for subsequent weeks.|24 weeks after the first vaccination|All subjects who received at least one vaccination|||titre||95% Confidence Interval|Geometric Mean
1376826|NCT01489358|Primary|Number of Subjects Reporting 1 or More Unsolicited Adverse Event|"Unsolicited adverse events were recorded from enrollment through 28 days after the second vaccination; and from the third vaccination through 28 days after this vaccination.~Between and after the indicated time periods, through the last expected study visit (i.e., 24 weeks after the third vaccination), only SAEs and new chronic medical conditions were recorded. The number of unsolicited events reported for Group 3 here is lower than the total number of adverse events in the Adverse Event Module, which reports both solicited and unsolicited adverse events."|28 days after each vaccination|All subjects who received at least one vaccination|||participants|||Number
1376827|NCT01489358|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 44 weeks after the first vaccination.|44 weeks after first vaccination|All subjects who received at least one vaccination|||participants|||Number
1376829|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after any vaccination|All subjects who received at least one vaccination|||participants|||Number
1376830|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination|||participants|||Number
1376831|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination|||participants|||Number
1376832|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination|||participants|||Number
1376833|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after any vaccination|Number of subjects who received at least one vaccination|||participants|||Number
1376834|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination|||participants|||Number
1376835|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination|||participants|||Number
1376836|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination|||participants|||Number
1376837|NCT01489254|Primary|The Number of T1-Gadolinium Enhancing Lesions During Months 7-9|The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.|9 months|Full Analyis Set (FAS): all randomized subjects who received at least 1 dose of trial medication|||Number of lesions||95% Confidence Interval|Mean
1376838|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss||2-year|Participants that completed the 2-year visit.|||eyes|Eyes||Number
1376839|NCT01489189|Secondary|Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years||2-years|Eyes with baseline diabetic retinopathy level 61B or worse (active neovascularization). Last-observation-carried-forward was used for 23 eyes in the anti-VEGF+Deferred PRP group and 25 eyes in the Prompt PRP group missing photographs at 2 years if 1-year fundus photographs were available.|||eyes|Eyes||Number
1376840|NCT01489189|Secondary|Number of Eyes With Vitreous Hemorrhage||2-years||||Eyes|Eyes||Number
1376841|NCT01489189|Secondary|Development of Central DME With Vision Impairment by 2-years||2-years|Excludes that did not have central DME with vision impairment (20/32 or worse) at baseline.|||eyes|Eyes||Number
1376842|NCT01489189|Secondary|Mean Change in OCT Central Subfield Thickness From Baseline|All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.|2-years|Eyes with optical coherence tomography (OCT) data at baseline and 2-years.|||µm|Eyes|95% Confidence Interval|Mean
1376843|NCT01489189|Secondary|Frequency of Vitrectomy||2-years||||eyes|Eyes||Number
1376859|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|"If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.~AB=antibodies in category for outcome measure data."|Throughout study period (approximately 17 months)||||Participants|||Number
1376844|NCT01489189|Secondary|Humphrey Visual Field Test Cumulative Score Change From Baseline|Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test [for each quadrant], and from 0 to about 400 or 450 for the peripheral test.|2-years|Humphrey visual fields were obtained at a subset of sites. Fields with excessive false positive response, excessive false negative response, or excessive fixation loss were excluded from analysis. Twenty-two eyes in the anti-VEGF+deferred PRP group and 25 eyes in the prompt PRP group were excluded.|||decibels|Eyes|Inter-Quartile Range|Median
1376845|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain||2-years|Eyes with a baseline letter score of 78 or less (approximate Snellen equivalent 20/32 or worse) from participants that completed the 2-year visit.|||eyes|Eyes||Number
1376846|NCT01489189|Secondary|Mean Visual Acuity|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.|||letters|Eyes|Standard Deviation|Mean
1376847|NCT01489189|Primary|Mean Change in Visual Acuity From Baseline|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.|||letters|Eyes|95% Confidence Interval|Mean
1376848|NCT01488994|Secondary|Health Resource Use: Days Lost From School|The number of days lost from school per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who missed days from school|||Days||Full Range|Median
1376849|NCT01488994|Secondary|Health Resource Use: Emergency Room Visits|The number of Emergency Room visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26||||Visits||Full Range|Median
1376850|NCT01488994|Secondary|Health Resource Use: Unscheduled Doctor's Office Visits|The number of unscheduled doctor's Office visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who had unscheduled visits to a doctor's office|||Visits||Full Range|Median
1376851|NCT01488994|Secondary|Health Resource Use: Length of Hospitalization|The length of hospitalization per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26||||Days||Full Range|Median
1376852|NCT01488994|Secondary|Health Resource Use: Number of Hospitalizations|The number of hospitalizations per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26||||Hospitalizations||Full Range|Median
1376853|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): Haemo-QoL, Change From Baseline in Total Score|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline and 6 months|Participants in the Full Analysis Set who had Haemo-QoL data for baseline and 6 months|||Scores on a scale||Standard Deviation|Mean
1376854|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): PedsQL™ Change From Baseline in Total Score|"For this study, the PedsQL™ questionnaires for participants 2 to 7 years of age (parent-proxy versions for age groups 2-4 years and 5-7 years) and PedsQL™ Child version for participants 8 to 12 years of age were used.~The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. A 5-point score is used for each domain: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0 so that higher scores indicate better quality of life (QoL). The total score is the mean (average) of all scores from the 4 domains.~The change from baseline in total score is reported- a positive score indicates a better QoL compared to baseline and a negative score indicates a poorer QoL compared to baseline."|Baseline and 6 months|Participants in the Full Analysis Set who had PedsQL™ data for baseline and 6 months|||Scores on a scale||Standard Deviation|Mean
1376855|NCT01488994|Secondary|Safety: Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins and Recombinant Furin (rFurin)|If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.|Throughout study period (approximately 17 months)||||Participants|||Number
1376856|NCT01488994|Secondary|Safety: Number of Participants With Clinically Significant Changes in Routine Laboratory Parameters (Haematology and Clinical Chemistry), and Vital Signs|"Categories consist of Clinically Significant (CS) changes in haemaotology parameters, clinical chemistry parameters and vital signs.~Abbreviations in categories; Clin=clinical; params=parameters"|Throughout study period (approximately 17 months)||||Participants|||Number
1376866|NCT01488994|Secondary|Hemostatic Efficacy: Prophylaxis: Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during prophylaxis was calculated only for participants who had adequate treatment time for bleeding rate assessment (i.e., more than 3 months of prophylaxis treatment). The observation period for prophylaxis was to be the time between the first and the last prophylactic infusions. The treatment period for surgery was to be excluded from the bleed rate calculation.~ABR calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25."|Throughout study period (approximately 17 months)||||Bleeding episodes per year||Standard Deviation|Mean
1376867|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Resolution of Bleed|"Rating Scale for Treatment of bleeding episodes (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes|||Bleeding Episodes|Bleeding Episodes||Number
1376868|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode||Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes|||Bleeding Episodes|||Number
1376869|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) Over Time|"IR calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose. IR is determined at baseline (PK analysis), Week 5, Week 13 and Week 26 timepoints.~Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants > 6 years of age; pediatric participants 6 to <12 years of age; pharmacokinetic Full Analysis Set (PKFAS)."|Within 30 mins pre-infusion and 30 mins post-infusion at baseline, Week 5, Week 13 and Week 26.||||IU/dL : IU/kg||Standard Deviation|Mean
1376870|NCT01488994|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Computed as Clearance (CL) * Mean residence time (MRT)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||dL/kg||Standard Deviation|Mean
1376871|NCT01488994|Secondary|Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|Calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||hours (hr)||Standard Deviation|Mean
1376872|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|The rise in FIX activity in IU/dL per unit dose administered in IU/kg. Calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose|Within 30 mins pre-infusion and 30 mins post-infusion||||IU/dL : IU/kg||Standard Deviation|Mean
1376873|NCT01488994|Secondary|Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|Computed as the dose divided by total Area under the curve (AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||dL/(kg*hr)||Standard Deviation|Mean
1376874|NCT01488994|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|Computed as total area under the first moment curve (total AUMC) divided by the total area under the concentration versus time curve (total AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||hours (hr)||Standard Deviation|Mean
1376875|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity Post-infusion Per Dose (Total AUC/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||IU*hour (hr)/dL||Standard Deviation|Mean
1376876|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion Per Dose (AUC 0-72h/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints|On completion of the study, prospective changes to the planned statistical analysis were made not to analyze AUC 0-72h due to the different time points for the last PK blood sample. Only total AUC [i.e. AUC 0-infinity] was included in the PK analysis.||||||
1376877|NCT01488994|Primary|Adverse Events (AEs) Possibly or Probably Related to BAX326||Throughout study period (approximately 17 months)|Full analysis set|||AEs considered related to BAX326|||Number
1376878|NCT01488877|Secondary|Change From Baseline in Sitting Pulse Rate at Day 15|Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
1376879|NCT01488877|Secondary|Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15|Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1376880|NCT01488877|Secondary|Plasma Pharmacokinetic (PK) Parameters|PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.|0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14|Data for all pre-specified PK parameters were not analyzed because a decision was made to prematurely terminate the study.||||||
1376881|NCT01488877|Primary|Number of Participants With Confirmed and Severe Hyperkalemia|Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level >= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.|Baseline up to Day 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1376882|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 15|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.|Baseline, Day 14, 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||mEq/L||Full Range|Median
1376883|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 8|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.|Baseline, Day 7, 8|Safety analysis set included all participants who received at least 1 dose of study medication.|||milliequivalent/liter (mEq/L)||Full Range|Median
1376884|NCT01488708|Secondary|Change in Anti-double-stranded Deoxyribonucleic Acid Level||Baseline, 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
1376885|NCT01488708|Secondary|Proportion of Participants With Improvement in Lupus Quality of Life||4 years|Zero participants analyzed. Data was not collected for analysis.||||||
1376886|NCT01488708|Secondary|Occurrence of New Severe SLE Flares||Baseline through 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
1376887|NCT01488708|Secondary|Change in SLE Disease Activity Index||Baseline, 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
1376888|NCT01488708|Secondary|Proportion of Participants With a Reduction in Steroid Dose||Baseline through 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
1376889|NCT01488708|Secondary|Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response||Week 48|Zero participants analyzed. Data was not collected for analysis.||||||
1376890|NCT01488708|Primary|Percentage of Participants With Adverse Events (AEs)|A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Baseline through 4 years|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1376891|NCT01488578|Primary|Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.|The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.|||events|||Number
1376892|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment|Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376893|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day|Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376894|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)|Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376895|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency|Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376993|NCT01487525|Secondary|Knee Pain|Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire Pain Sub-Scale (0-100); larger absolute values represent less pain; a positive % changes indicates a reduction in pain|0, 6 weeks||||Percent change||Standard Deviation|Mean
1376896|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder|Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376897|NCT01488578|Secondary|Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.|||events|||Number
1376898|NCT01488578|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy|Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor.|12 week|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1376899|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Age|Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376900|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Complications|Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376901|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Gender|Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376902|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies|Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376903|NCT01488578|Primary|Number of Participants With an Investigator’s Assessment of Clinical Outcome at End of the Study.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.|12 week|"The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.~Number of participants evaluable for which was evaluated effect."|||participants|||Number
1376904|NCT01488578|Primary|"Number of Participants Which Was Evaluated as Degree of Satisfaction."|Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376905|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs|Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1376906|NCT01488578|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|12 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.|||participants|||Number
1376907|NCT01488487|Secondary|Objective Response Rate (ORR)|"ORR is the rate of complete responses (CRs) + partial responses (PRs) as determined by RECIST (v1.1) and modified HCC RECIST criteria. Responses defined as follows:~CR: disappearance of all clinical/radiological evidence of tumor including any intratumoral arterial enhancement in all target lesions.~Partial Response (PR): at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, referencing the baseline sum.~Stable Disease (SD): any cases that do not qualify for either partial response or progressive disease.~Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of viable target lesions, referencing the nadir sum, and/or the appearance of one or more new lesions. A new hepatic nodule signals PD when the longest diameter is at least 10 mm and the nodule shows the typical vascular pattern of HCC on dynamic imaging or if at least 1-cm interval growth is seen in subsequent scans."|3.5 years|Two patients were not evaluable; one due to death prior to radiographic evaluation (death clinically attributed to progressive disease) and the other due to early termination of treatment due to intolerance.|||percentage of participants|||Number
1376908|NCT01488487|Secondary|Overall Survival (OS)|Overall survival is defined as the time from study enrollment until death.|3.5 years||||months||95% Confidence Interval|Median
1376909|NCT01488487|Secondary|Number of Individuals Experiencing Toxicity|Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).|3.5 years||||participants|||Number
1376994|NCT01487525|Secondary|Isokinetic Knee Extensor Strength||0, 6 weeks||||percent change||Standard Error|Mean
1376910|NCT01488487|Primary|Time to Progression (TTP)|Time to progression is defined as the time from study enrollment until radiological progression in a previously embolized lobe, development of new lesions in an untreated lobe, or evidence of extrahepatic progression (based on modified Hepatocellular Carcinoma (HCC) Response Evaluation Criteria In Solid Tumors (RECIST) criteria). Patients will be followed until death. Patients that die of causes unrelated to the study drug without evidence of progression will be censored.|3.5 years||||months||95% Confidence Interval|Median
1376911|NCT01488448|Primary|Length of Stay in the Study-LOS by Per Protocol Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Per protocol analysis (only includes participants who completed the study)|||Days||Inter-Quartile Range|Median
1376912|NCT01488448|Post-Hoc|LOS Analysis for Patients Whose Study Entry Respiratory Distress Assessment Instrument (RDAI) Was Greater Than or Equal to 4 or Who Had Hypoxia <92%||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of patients who had a study entry Respiratory Distress Assessment Instrument (RDAI) of greater than or equal to 4 points OR hypoxia <92% on admission|||days||Inter-Quartile Range|Median
1376913|NCT01488448|Post-Hoc|LOS Subgroup Analysis of Patients With a History of Prematurity||through hospitalization/while receiving study medication, average 2-3 days|Patients who reported a history of prematurity/whose Gestational age was <37 weeks|||days||Inter-Quartile Range|Median
1376914|NCT01488448|Post-Hoc|LOS in Patients With a History of Previous Wheeze||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of the study population who reported a history of wheezing prior to this admission|||days||Inter-Quartile Range|Median
1376915|NCT01488448|Post-Hoc|LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)||through hospitalization/while receiving study medication, average 2-3 days|This is the population in the study whose RSV testing was positive.|||days||Inter-Quartile Range|Median
1376916|NCT01488448|Secondary|Total Adverse Events|Clinical worsening events (defined prior) + 7 day readmissions|Time of enrollment in the study through 1 week after hospital discharge||||adverse events|||Number
1376917|NCT01488448|Secondary|Clinical Worsening|transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment|though hospitalization/time period receiving study treatment, average 2-3 days|all patients enrolled in the study were analyzed for events related to clinical worsening|||participants|||Number
1376918|NCT01488448|Secondary|Readmission for Bronchiolitis Within 7 Days of Discharge|Phone call at 7 days to assess for readmission to any hospital|within 7 days of hospital discharge|This population is those who completed the study.|||participants|||Number
1376919|NCT01488448|Primary|Length of Stay in the Study-LOS--Intention to Treat Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Intention to Treat Analysis|||Days||Inter-Quartile Range|Median
1376920|NCT01488409|Secondary|Change From Baseline in Lipid Profile at 6-months|Change in direct low density lipoprotein (LDL) cholesterol is given|Change from Baseline to 6-months|all available data used|||mg/dL||Standard Deviation|Mean
1376921|NCT01488409|Secondary|Change From Baseline in Intramyocellular Lipid Content at 6-months|Change in tibialis intramyocellular lipid (IMCL) normalized to creatinine is given.|Change from Baseline to 6-months|all available data used|||ratio of IMCL peak to Creatinine peak||Standard Deviation|Mean
1376922|NCT01488409|Secondary|Change From Baseline in Mitochondrial Density at 6 Months|Muscle tissue obtained from biopsy will be used to assess mitochondrial number and morphology by microscopes at Baseline and at 6-months. The change in mitochondrial density from 6 months to baseline is given.|Change from Baseline to 6-months|all available data used|||percentage of total muscle fiber area||Standard Deviation|Mean
1376923|NCT01488409|Secondary|Change From Baseline in Insulin Sensitivity at 6-months|Change in insulin resistance assessed by hyperinsulinemic-euglycemic clamp study at Baseline and at 6-months. Change in insulin-stimulated glucose uptake (M) during 40 mU/m2/min insulin clamp is given.|Change from Baseline to 6-months visit|all available data used|||mg/kg/min||Standard Deviation|Mean
1376924|NCT01488409|Primary|Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months|The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.|Change from Baseline to 6-months Visit|all available data used|||mM/s||Standard Deviation|Mean
1376925|NCT01488370|Secondary|Successful Intubation After Four Laryngoscopy Attempts||Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes||||Participants|||Count of Participants
1376926|NCT01488370|Secondary|Successful Intubation After Three Laryngoscopy Attempts||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.||||Participants|||Count of Participants
1376927|NCT01488370|Secondary|Successful Intubation After Two Laryngoscopy Attempts||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.||||Participants|||Count of Participants
1376928|NCT01488370|Secondary|Successful Intubation After One Laryngoscopy Attempt|Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.|Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.||||Participants|||Count of Participants
1376995|NCT01487525|Primary|Change in Isotonic Leg Press 1RM|double leg press 1 rep maximum strength|0,6 weeks||||percent change||Standard Deviation|Mean
1376929|NCT01488370|Primary|Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia|Time to successful tracheal intubation|||Seconds||95% Confidence Interval|Mean
1376930|NCT01488318|Secondary|Overall Survival (OS)|From date of entry into the study until the date of death from any cause, assessed up to 60 months.|Up to 60 months||||months||90% Confidence Interval|Median
1376931|NCT01488318|Secondary|Progression-free Survival (PFS)||Up to 36 months||||months||90% Confidence Interval|Median
1376932|NCT01488318|Primary|Response to Treatment|Response of evaluable patients to treatment, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Up to 36 months|Patients that received Cetuximab dosed at 250 mg/m^2/week and Dasatinib 150 mg daily who were evaluable for response.|||participants|||Number
1376933|NCT01488318|Primary|Overall Response Rate (ORR)|Number of patients experiencing a Complete Response (CR) + Partial Response (PR) to study treatment / Total number of evaluable patients, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Up to 36 months|Patients that received Cetuximab dosed at 250 mg/m^2/week and Dasatinib 150 mg daily who were evaluable for response.|||percentage of participants|||Number
1376934|NCT01488279|Secondary|Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose)|We measured the change in insulin secretion (AIRg or acute insulinogenic response to glucose) during the MTT and compared the insulin secretion on the DPP4 inhibitor (sitagliptin) compared to placebo. We had expected the AIRg to be greater with DPP4i compared to placebo.|measured twice: on day #8 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #8 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT||||pmol/l||Standard Error|Least Squares Mean
1376935|NCT01488279|Secondary|Change in Glucose Response|Change in glucose response during the MTT. This was the Si (insulin sensitivity). We sought to determine whether there was an improvement in the glucose response after a meal on the DPP4i compared to placebo in the face of steroid (dexamethasone).|measured on day #9 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #9 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT||||response x 10000 / minute / microUnit/ml||Standard Error|Least Squares Mean
1376936|NCT01488279|Secondary|Change in Active GLP-1|As with GIP, we had planned to measure the difference or change in active GLP-1 in response to the MTT between the 2 study drug periods: on sitagliptin versus on placebo. We had hypothesized that GIP and GLP-1 would be elevated while on the DPP4 inhibitor compared to placebo as this is the mechanism of action of the drug sitagliptin. When other measures were negative, we elected not to pursue this due to time and cost.|Active GLP-1 would have been measured during MTT after 1 week of dex + sitagliptin and again after 1 week of dex + placebo, but we did not measure active GLP-1|We did not measure GLP-1||||||
1376937|NCT01488279|Secondary|Change in Active GIP|We had planned to measure the difference or change in active GIP in response to the MTT between the 2 study drug periods: on sitagliptin versus on placebo. However, when other measures were negative, we opted not to pursue this lab assay for cost and time. We did not perform measures of GIP.|Active GIP would have been measured during MTT after 1 week of dex + sitagliptin and again after 1 week of dex + placebo, but we did not measure active GIP|We did not measure GIP||||||
1376938|NCT01488279|Primary|Insulin Sensitivity|Insulin Sensitivity measured at the end of each treatment period. The primary outcome variable was the difference in the disposition index (DI) determined as the product of the acute insulin response to glucose (AIRg) x the insulin sensitivity index (SI) in subjects during IVGTT on the 8th day (after 7 days) of on dex + placebo, then a after a washout of approximately 4 weeks, participants crossed over to dex + sitagliptin 100 mg x 7 days. Subjects were randomized to order of medication. The primary analyses will be an ANCOVA, including baseline responses as a covariate.|Measured on day #8 (after 8 days of sitagliptin or placebo) followed by a 4 week washout then measured again on day #8 (after 8 days of crossover treatment).|Subjects were randomized to the order to study medication (dex + sitagliptin vs dex + placebo) by the pharmacy in order to keep double blinding|||ratio without units||Standard Error|Mean
1376939|NCT01488188|Secondary|Cell Mediated Immune Responses|Interferon gamma production in peripheral blood monocyte (PBMC) after in vitro re-stimulation with influenza virus antigen at 21 days after vaccination.|21 days after vaccination||||pg/ml||Full Range|Median
1376940|NCT01488188|Secondary|Salivary IgA|Salivary Flu-specific IgA titer at Days 21 after vaccination|21 days after vaccination||||Titer||Full Range|Median
1376941|NCT01488188|Secondary|Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus|Flu virus-specific IgG- and IgA -antibody secreting cells per ml of blood at 7 days after vaccination|7 days after vaccination||||cells/ml||Full Range|Median
1376942|NCT01488188|Primary|Passive Haemagglutination Inhibition Titer.|Passive haemagglutination inhibition titer of serum at 21 days after vaccination.|21 days after vaccination||||Titer||Full Range|Median
1376943|NCT01488097|Secondary|Changes From Baseline In Hs-CRP|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for high sensitivity C-reactive protein (hs-CRP). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom hs-CRP data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||mg/L||Standard Deviation|Mean
1376944|NCT01488097|Secondary|Changes From Baseline In Serum Ferritin|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for serum ferritin. Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom serum ferritin data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||microgram (µg)/L||Standard Deviation|Mean
1376945|NCT01488097|Secondary|Changes From Baseline In Serum Lipids|Lipid changes from Baseline to Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS were measured in serum for total cholesterol (Total-C), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), and triglycerides (TG). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom lipid data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||mg/dL||Standard Deviation|Mean
1376946|NCT01488097|Secondary|Changes From Baseline In GGT And ALP|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for gamma glutamyltransferase (GGT) and alkaline phosphatase (ALP). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom GGT and ALP data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||U/L||Standard Deviation|Mean
1376947|NCT01488097|Secondary|Changes From Baseline In Liver Fat Content|Changes in liver fat content from Baseline to Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, and Week 260, as assessed by multi-echo gradient-echo MRI. Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, and Week 260|Participants in the FAS for whom liver fat content data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||percentage fat fraction||Standard Deviation|Mean
1376948|NCT01488097|Secondary|Changes From Baseline In Liver Volume|Changes in liver volume from Baseline to Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS was assessed by magnetic resonance imaging (MRI). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04. Liver volume was expressed as multiples of normal (MN), where normal is defined as 2.5% of body weight.|Baseline, Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom liver volume data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||Multiples of Normal (MN)||Standard Deviation|Mean
1376949|NCT01488097|Secondary|Changes From Baseline In ALT And AST|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the Full Analysis Set (FAS) for whom ALT and AST data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||units (U)/liter (L)||Standard Deviation|Mean
1376950|NCT01488097|Primary|Number Of Participants Reporting TEAEs And IARs|Safety and tolerability of sebelipase alfa was primarily assessed by monitoring the number of participants reporting treatment-emergent adverse events (TEAEs), including serious adverse events, and infusion-associated reactions (IARs). The number of participants who discontinued from the study due to a TEAE is also presented. An IAR was defined as any adverse event that occurred during the 2-hour infusion or within 4 hours after the end of the infusion and was assessed by the investigator as at least possibly related to study drug. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. TEAEs that occurred after the first dose administration at Week 1 through the End of Study (EOS) are presented. End of study was 30 days (+ 7 days) after the last dose of study drug (at Week 260).|From after first dose administration post-Baseline through EOS during study LAL-CL04|Safety Analysis Set: All participants who received any amount of study drug in the extension study.|||Participants|||Count of Participants
1376951|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
1376952|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 8|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
1376953|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)||Week 12|FAS, LOCF|||percentage of participants|||Number
1376954|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF|||percentage of participants|||Number
1376955|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 12|FAS, LOCF|||percentage of participants|||Number
1376956|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 8|FAS, last observation carried forward (LOCF)|||percentage of participants|||Number
1376957|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 12||Week 12|FAS|||units on a scale||Standard Error|Mean
1376996|NCT01487499|Secondary|Overall Survival|Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.|5 years|||||||
1376997|NCT01487499|Secondary|Progression-free Survival||18 months|||||||
1376958|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. Higher score = more affected.|Week 8|FAS|||units on a scale||Standard Error|Mean
1376959|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
1376960|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 8|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
1376961|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
1376962|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 8|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
1376963|NCT01488071|Secondary|Change From Baseline in MADRS Total Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
1376964|NCT01488071|Primary|Change From Baseline in MADRS Total Score at Week 8|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
1376965|NCT01488019|Secondary|Rescue Medication Usage|Number of puffs of rescue medication (albuterol pMDI) used per day|0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||Mean Puffs per Day||Standard Deviation|Mean
1376966|NCT01488019|Secondary|Summary of Subjects Requiring Intubation or Non-Invasive Ventilation||0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||Participants|||Count of Participants
1376967|NCT01488019|Secondary|Health Care Utilization and Economic Impact - Number of Emergency Department Visits||0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||Participants|||Count of Participants
1376968|NCT01488019|Secondary|Transition Dyspnea Index|The Transition Dyspnea Index (TDI) measures changes in dyspnea severity from the baseline as established by the BDI. It has 3 components: change in functional impairment, change in magnitude of task, and change in magnitude of effort, and each component is rated on a scale ranging from -3 (major deterioration) to +3 (major improvement). The 3 components are summed to provide a total score ranging from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.|On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||units on a scale||Standard Error|Least Squares Mean
1376969|NCT01488019|Secondary|Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12|Saint Georges Respiratory Questionnaire comprises 50 items in 3 sections, Symptoms, Activity, Impact, measuring health status in chronic airflow limitation. Symptoms captures level of symptomatology. Activity and Impact responses are either “yes” or “no”. Scoring is from 0 to 100; 0 = no life quality impairment. A summary score for all items is calculated and ranges from 0 to 100, where 0 indicates best possible health status, 100 represents worst possible health status. Scores are calculated using weights attached to each item in the questionnaire - 4 unit changes are clinically meaningful.|On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected were included|||units on a scale||Standard Error|Least Squares Mean
1376970|NCT01488019|Secondary|IC Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included|||Litres||Standard Deviation|Mean
1376971|NCT01488019|Secondary|FVC Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included|||Litres||Standard Deviation|Mean
1376972|NCT01488019|Secondary|FEV1 Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included|||Litres||Standard Error|Least Squares Mean
1376983|NCT01487668|Primary|Physical Health-related Quality of Life|The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months||||units on a scale||Standard Deviation|Mean
1376973|NCT01488019|Secondary|Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks|COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication.The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||percent|||Number
1376974|NCT01488019|Secondary|Number of Subjects With Protocol-Defined COPD Exacerbation|COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication. The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Count of Participants
1376975|NCT01488019|Secondary|Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization||0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Count of Participants
1376976|NCT01488019|Secondary|Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality|An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Number
1376977|NCT01488019|Primary|Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks|The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||percent|||Number
1376978|NCT01488019|Primary|Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation|The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Count of Participants
1376979|NCT01487954|Secondary|Change in Urine pH|A paired sample t-test (a=0.05) assessing change in urine pH between before treatment day 0 and after radiation and alkaline water treatment day 33.|at baseline and at week 5 (day 33)|Only the first ten patients in the alkaline water group, who took part in the safety lead-in portion of the study were analyzed for urine pH|||units on pH scale||Standard Deviation|Mean
1376980|NCT01487954|Primary|Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen. Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment. Observed toxicity differences among the treatment arms may be reported in frequency tables.|at 1 month after treatment||||percentage of participants|||Number
1376981|NCT01487863|Primary|Cumulative CD54 Upregulation Ratio Between the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Over the course of sipuleucel-T therapy (approximately 1 month)|The efficacy population is defined as all randomized subjects. All the subjects in the efficacy population were analyzed according to the treatment that they were randomized to receive.|||Ratio ofCD54 molecules on BDS65:FP cells||Standard Error|Mean
1376982|NCT01487668|Secondary|Improved Mental Health-related Quality of Life|Change in SF-12 mental health scores from baseline to 12 months. The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months||||units on a scale||Standard Deviation|Mean
1376998|NCT01487499|Primary|Solid Tumor Growth After Completion of Interventional Bronchoscopies|The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.|18 months|No participants were analyzed because total enrollment numbers were too low to meet any statistical analysis.||||||
1376999|NCT01487265|Secondary|Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.|Adverse events will be graded using CTCAE v4.3. and will be collected until 30 days after the discontinuation of study treatment for each participant. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.|Every 2 weeks for 8 weeks, then every 8 weeks thereafter, estimated 24 months|Patients that received at least one dose of study treatment|||participants|||Number
1377000|NCT01487265|Secondary|Objective Response Rate|Defined as the percentage of complete and partial responses (CR + PR) among all patients. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 months|patients that received at least one dose of study treatment|||percentage of participants||95% Confidence Interval|Number
1377001|NCT01487265|Secondary|Duration of Response|Defined as the time from complete or partial response (CR or PR) until objective tumor progression. Tumor measurements will be obtained using CT scans of chest, abdomen and pelvis and assessed per RECIST v 1.1. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 months|Of 37 participates that received study treatment, only two participants met the minimum criteria to be included (one censored, and the remaining one analyzed for duration of response)|||months|||Number
1377002|NCT01487265|Secondary|Overall Survival|Defined as the time from first treatment until death from any cause.|every 3 months after study treatment, projected 24 months|Patients that received at least one dose of study treatment|||months||95% Confidence Interval|Median
1377003|NCT01487265|Primary|Progression Free Survival at 3 Months|Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.|3 months|Patients that were treated with at least one dose of study treatment|||percentage of participants|||Number
1377004|NCT01487161|Secondary|Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.||8 weeks||||tablets (1tablet= 500 mg)||Standard Error|Least Squares Mean
1377005|NCT01487161|Secondary|Clinical Global Impression of Change Scores at Week 8|The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|8 weeks||||units on a scale||Standard Deviation|Least Squares Mean
1377006|NCT01487161|Secondary|Patient Global Impression of Change Scores at Week 8|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Week 8||||units on a scale||Standard Error|Least Squares Mean
1377007|NCT01487161|Secondary|Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks||||Participants|||Count of Participants
1377008|NCT01487161|Secondary|Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks||||Participants|||Count of Participants
1377009|NCT01487161|Secondary|Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks||||Participants|||Count of Participants
1377010|NCT01487161|Secondary|Percent of Responders According to OMERACT-OARSI Criteria at Week 8|Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.|8 weeks||||Participants|||Count of Participants
1377011|NCT01487161|Secondary|WOMAC C (Function Subscale) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
1377047|NCT01486927|Secondary|AUC0-∞ (Part 1)|AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||IU*h/dL||Standard Deviation|Mean
1377012|NCT01487161|Secondary|WOMAC B (Stiffness Subscale) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
1377013|NCT01487161|Secondary|WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
1377014|NCT01487161|Secondary|WOMAC A (Pain Subscale) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
1377015|NCT01487161|Secondary|Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 1-7 and Week 9 and 11|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
1377016|NCT01487161|Secondary|Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 8, 10 and 12|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
1377017|NCT01487161|Primary|Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|12 weeks|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
1377018|NCT01487161|Primary|Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|10 weeks|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
1377019|NCT01487161|Primary|Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
1377020|NCT01486966|Secondary|Incidence of Hypoglycaemic Episodes|"All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.~Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl).~A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal."|Weeks 0-2|Safety analysis set included all subjects receiving at least one dose of the trial products.|||events|||Number
1377021|NCT01486966|Secondary|Change From Baseline in Fructosamine After Two Weeks of Treatment||Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||Umol/L||Standard Error|Least Squares Mean
1377022|NCT01486966|Secondary|Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment|FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
1377023|NCT01486966|Secondary|Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment|FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L.|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
1377024|NCT01486966|Secondary|Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
1377025|NCT01486966|Secondary|Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
1377026|NCT01486966|Secondary|Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment|The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
1377066|NCT01486615|Secondary|Number of Patients With Intact Memory|Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.|24 hour after surgery||||Participants|||Number
1377027|NCT01486966|Secondary|Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment|The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
1377028|NCT01486966|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment|The FPG referred to pre-breakfast plasma glucose.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
1377029|NCT01486966|Primary|Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment|Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
1377030|NCT01486927|Other Pre-specified|AUC0-∞ (Part 3)|AUC0-∞ (AUC from 0 extrapolated to infinity) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion||||IU*h/dL||Standard Deviation|Mean
1377031|NCT01486927|Other Pre-specified|Cmax (Part 3)|Cmax of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion||||IU/dL||Standard Deviation|Mean
1377032|NCT01486927|Other Pre-specified|Tmax (Part 3)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after an initial and repeat infusion of rVIII-SingleChain.|Before infusion and at up to 12 time points within 96 hours of infusion.||||hours||Full Range|Median
1377033|NCT01486927|Other Pre-specified|Half-life (t1/2) (Part 3)|Half-life (t1/2) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||hours||Standard Deviation|Mean
1377034|NCT01486927|Other Pre-specified|Mean Residence Time (MRT) (Part 3)|Mean residence time (MRT) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||hours||Standard Deviation|Mean
1377035|NCT01486927|Other Pre-specified|Clearance (Cl) (Part 3)|Clearance (Cl) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||mL/h/kg||Standard Deviation|Mean
1377036|NCT01486927|Other Pre-specified|Volume of Distribution at Steady-state (Vss) (Part 3)|Volume of distribution at steady-state (Vss) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||mL/kg||Standard Deviation|Mean
1377037|NCT01486927|Other Pre-specified|Incremental Recovery (Part 3)|Incremental recovery of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|At 30 minutes after infusion||||[IU/dL]/[IU/kg]||Standard Deviation|Mean
1377038|NCT01486927|Secondary|Proportion of Bleeding Episodes Requiring 1, 2, 3 or > 3 Infusions of rVIII-SingleChain to Achieve Hemostasis|Percentage of bleeding episodes requiring 1, 2, 3 or > 3 infusions of rVIII-SingleChain to achieve hemostasis. The denominator includes all treated bleeding episodes.|During the study (up to 24 months; assessed at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24)||||Percentage of bleeding episodes|Participants||Number
1377039|NCT01486927|Secondary|Annualized Bleeding Rate for Total Bleeds and Traumatic Bleeds|The annualized bleeding rate was derived for each subject as follows: 365.25*(number of bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months||||Number of bleeds per year||Inter-Quartile Range|Median
1377040|NCT01486927|Secondary|Incremental Recovery (Part 1)|Incremental recovery of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|At 30 minutes after infusion||||[IU/dL]/[IU/kg]||Standard Deviation|Mean
1377041|NCT01486927|Secondary|Volume of Distribution at Steady-state (Vss) (Part 1)|Volume of distribution at steady-state (Vss) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||mL/kg||Standard Deviation|Mean
1377042|NCT01486927|Secondary|Clearance (Cl) (Part 1)|Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||mL/h/kg||Standard Deviation|Mean
1377043|NCT01486927|Secondary|Mean Residence Time (MRT) (Part 1)|Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion||||hours||Standard Deviation|Mean
1377044|NCT01486927|Secondary|Half-life (t1/2) (Part 1)|Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion.||||hours||Standard Deviation|Mean
1377045|NCT01486927|Secondary|Tmax (Part 1)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain.|Before infusion and at up to 10 time points within 72 hours of infusion||||hours||Full Range|Median
1377046|NCT01486927|Secondary|Cmax (Part 1)|Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||IU/dL||Standard Deviation|Mean
1392951|NCT01329978|Secondary|Change in HCV RNA at Week 8||Baseline (Day 1) to Week 8|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1377048|NCT01486927|Primary|Treatment Success During the Peri-operative Surgical Sub-study|"Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator."|From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)||||% of surgeries with successful treatment|||Number
1377049|NCT01486927|Primary|Annualized Spontaneous Bleeding Rate|The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months||||Number of spontaneous bleeds per year||Inter-Quartile Range|Median
1377050|NCT01486927|Primary|Inhibitor Formation to FVIII|Number of subjects who develop inhibitors to FVIII|Up to 24 months||||participants|||Number
1377051|NCT01486927|Primary|Treatment Success|"The investigator rated the efficacy of the treatment based on a 4-point rating scale excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation."|Up to 24 months||||% bleeding events successfully treated|Participants|95% Confidence Interval|Number
1377052|NCT01486810|Primary|Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.|The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.|during 8 weeks of trial or length of participation|data available for 16 participants.|||mgs/day||Standard Deviation|Mean
1377053|NCT01486810|Primary|Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.|Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..|during 1 week of study participation|Although 17 participants were enrolled, one participant was lost to follow-up without any post-enrollment study data, therefore 16 participants were analyzed.|||Participants|||Count of Participants
1377054|NCT01486758|Secondary|Proportion of Participants With a Physician Diagnosis of Asthma|The proportion of participants with a physician diagnosis of asthma|Week 3-52||||Percentage of participants|||Number
1377055|NCT01486758|Secondary|Number of Children Who Were Prescribed Inhaled Corticosteroids||3-52 weeks following randomization||||Number of participants|||Number
1377056|NCT01486758|Secondary|Respiratory Symptoms Following RSV Bronchiolitis|Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)|3-52 weeks following randomization||||Number of days||Standard Deviation|Mean
1377057|NCT01486758|Secondary|Likelihood to Develop 3 or More Wheezing Episodes|Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis|Week 3-52|A Kaplan-Meier survival analysis was conducted to compare the likelihood of developing a third episode of wheezing among participants who received azithromycin versus those who received placebo.|||percentage of participants|||Number
1377058|NCT01486758|Secondary|Rates of Drug Related GI Side Effects.||One month from randomization||||Number of participants|||Number
1377059|NCT01486758|Secondary|Concentrations of IL-8 in Nasal Lavage on Day 15||Day 15||||pg/ml||Inter-Quartile Range|Median
1377060|NCT01486758|Primary|Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes|Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.|3-52 weeks following randomization||||Proportion of participants|||Number
1377061|NCT01486758|Primary|IL-8 Concentrations|Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.|Day 8||||Pg/ml||Inter-Quartile Range|Median
1377062|NCT01486615|Secondary|Number of Patients With Loss of Memory for Being Transferred to Operating Room.|Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.|24 hour after surgery||||Participants|||Number
1377063|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at one hour after premedication||||Centimeter||Standard Deviation|Mean
1377064|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at 30 minutes after premedication||||centimeter||Standard Deviation|Mean
1377065|NCT01486615|Secondary|Amount of Propofol Consumption|Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.|1 - 2 hour after premedication||||mg||Standard Deviation|Mean
1377067|NCT01486615|Secondary|Orientation Score|Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.|Orientation score at one hour after premedication||||units on a scale||Inter-Quartile Range|Median
1377068|NCT01486615|Secondary|Sedation Score at One Hour After Premedication|Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.|Sedation score at 1 hour after the premedication||||units on a scale||Inter-Quartile Range|Median
1377069|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Change from baseline in VAS anxiety score at 15 minutes after premedication|sample size of 16 patients in each group was determined by a power analysis (α, 0.05; β, 0.10) assuming that there will be 50% reduction in anxiety VAS from baseline in the experimental groups and 4% in the placebo group. To compensate for dropout cases and shifting from normality in data distribution, 20 cases were studied in each group.|||Centimeter||Standard Deviation|Mean
1377070|NCT01486446|Other Pre-specified|Sleep Interference Due to Pain in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded sleep interference scores in their diary cards for each night (scores were recorded upon waking).~Sleep Interference due to pain is scored using an 11 point numerical rating scale where 0 = pain does not interfere with sleep and 10 = completely interferes, unable to sleep due to pain.~A lower sleep interference score compared to Baseline indicates that the subjects' pain interfered with sleep less on treatment than during Baseline."|Baseline to 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
1377071|NCT01486446|Other Pre-specified|Daily Pain (Maximum Pain Intensity) in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded pain scores in their diary cards 3 times each day (upon waking, lunchtime and evening).~On each recording occasion, subjects recorded the maximum pain experienced since the previous recording occasion using an 11 point numerical rating scale of pain intensity, PINRS (where 0 = no pain and 10 = worst pain imaginable).~A lower score compared to Baseline indicates that the subjects experienced less severe pain on treatment than during Baseline."|Baseline to 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
1377072|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.~A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.~A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
1377073|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.~A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.~A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5||||Percentage of Baseline||Inter-Quartile Range|Mean
1377074|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.~A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
1377075|NCT01486446|Primary|Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2.~A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days||||cooling uses/day||Inter-Quartile Range|Mean
1377087|NCT01486199|Primary|Absorptive Clearance Rate|Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs.|study day 1|One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.|||percent cleared / 80 minutes||Standard Deviation|Mean
1377076|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.~A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5||||Percentage of Baseline||Inter-Quartile Range|Mean
1377077|NCT01486446|Other Pre-specified|Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use and duration of all non-pharmacological cooling methods used to relieve their EM pain each day during Treatment Period 2.~A smaller average duration of cooling each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days||||minutes/day||Inter-Quartile Range|Mean
1377078|NCT01486316|Other Pre-specified|Clinical Status Measures|"Characterize the difference in clinical status measures over time in each arm. Outcomes include Quality of Life (as measured by the Minnesota Living With Heart Failure Questionnaire, in which scores range from 0 (Best) to 105 (Worst), 6 Minute Hall Walk distance, and New York Heart Association (NYHA, ranging from Class I (Best) to Class IV (Worst))~Because of the small number of patients enrolled, formal statistical analyses were not performed and data were not summarized in aggregate."|0 to 18 months post-implant|Subjects randomized to the Risk Status Guided Arm|||Outcome of Patients During Guided Period|Outcome of Patients During Guided Period||Count of Units
1377079|NCT01486316|Other Pre-specified|Correlation of HFRS Status With Actions/Testing|"At scheduled visits in which the HFRS scores were available to clinicians, the scores were summarized, along with whether subjects experienced significant weight gain, high blood pressure, or reported heart failure symptoms.~Because of the small number of subjects randomized, no formal statistical analyses were performed."|6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)|Only randomized subjects who did not exit prior to the period in which clinicians could utilized the HFRS score (6-18 months for HFRS Guided Arm, 13-18 months for Control Arm) were included in the analysis.|||Visits with high/very high score|Visits with High/Very High HFRS Score||Number
1377080|NCT01486316|Primary|Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events|"Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of Low, Medium, High, and Very High. The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up.~Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score."|0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)||||participants|||Number
1377081|NCT01486238|Secondary|Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.|"There is a possibility that some subjects may not respond to the study treatment to which they have been assigned. Macular laser treatment is considered an alternative treatment for retinal edema. A lower proportion of subjects requiring macular laser treatment would indicate a superior treatment regimen.~This will be assessed at week 12, and again at week 24."|24 weeks|||||||
1377082|NCT01486238|Secondary|Mean Change From Baseline at Week 24 in Central Foveal Thickness|Optical Coherence Tomography (OCT) will be used to assess the central foveal thickness of each patient. The mean change from baseline to week 24 will be calculated for each patient.|24 Weeks|||||||
1377083|NCT01486238|Primary|Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.|The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score in the Study Eye compared with baseline at 24 weeks. The BCVA is to be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.|24 weeks|Proportion of subjects who gain two or more lines BCVA was calculated.|||participants|||Number
1377084|NCT01486199|Secondary|Mucociliary Clearance Rate|Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.|t=2 years, measure made 80 minutes after radiopharmaceutical inhalation|Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.|||percent cleared / 80 minutes||Standard Deviation|Mean
1377085|NCT01486199|Secondary|Absorptive Clearance Rate|Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs.|t=2 years|Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.|||percent cleared / 80 min||Standard Deviation|Mean
1377086|NCT01486199|Primary|Mucociliary Clearance Rate|Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.|study day 1|One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.|||percent cleared / 80 minutes||Standard Deviation|Mean
1377088|NCT01486043|Secondary|Hemoglobin A1c||At 1 month||||percent of hemoglobin||Full Range|Mean
1377089|NCT01486043|Secondary|Serum Fructosamine Level||At 1 month||||uM||Full Range|Mean
1377090|NCT01486043|Primary|Length of Insulin Therapy (Days)||During the 30 days of induction chemotherapy (plus or minus 2 weeks)||||days||Full Range|Mean
1377091|NCT01485991|Secondary|Percentage of Participants With Viral Relapse|Participants are considered to have a viral relapse if both conditions as specified are met: 1) <25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (>=) 25 IU/mL during follow-up.|End of Treatment (Week 48) up to Follow-up Period (until Week 72)|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1377092|NCT01485991|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than <25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable (24 weeks after the planned EOT).|24 Weeks After the Planned EOT (Week 48)|ITT population included all randomized participants who took at least 1 dose of study medication.|||percentage of participants|||Number
1377093|NCT01485991|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable.|12 Weeks After the Planned End of Treatment (EOT: Week 48)|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication.|||percentage of participants|||Number
1377094|NCT01485887|Secondary|Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score and QIDS16-SR-J score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
1377095|NCT01485887|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
1377096|NCT01485887|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
1377097|NCT01485887|Secondary|Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
1377098|NCT01485887|Primary|Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.|||Participants|||Number
1377099|NCT01485887|Primary|Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes|Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)> 450 millisecond (ms), >480 ms, and >500 ms respsctively, change from baseline in QTc, QTcB, and QTcF >= 30 ms, and >= 60 ms, respectively.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the electrocardiogram while on study treatment.|||Participants|||Number
1377100|NCT01485887|Primary|Number of Participants With Clinical Significant Laboratory Tests Changes|Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count <0.8 x lower limit normal (LLN); Lymphocytes (%) <0.8 x LLN; Eosinophils (%) >1.2 x upper limit normal (ULN); Total Bilirubin >1.5 x ULN; Alanine Aminotransferase (ALT) >3.0 x ULN; Gamma glutamyl transferase (GGT) >3.0 x ULN; Uric Acid >1.2 x ULN; Cholesterol >1.3 x ULN; Low density lipoprotein (LDL) cholesterol >1.2 x ULN; Triglycerides >1.3 x ULN; Glucose >1.5 x ULN; Urine Glucose [qualitative (Qual)] >=1; Urine Protein (Qual) >=1; Urine Blood/Hemoglobin (Hgb) (Qual) >=1.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the given laboratory test while on study treatment or during lag time.|||Participants|||Number
1377101|NCT01485887|Primary|Number of Participants With Clinical Significant Vital Changes|Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP >= 90 mmHg with change from the baseline >= 10 mmHg; SBP >= 140 mmHg with change from the baseline >= 20 mmHg; PR >= 100 bpm with change from the baseline >= 15 bpm.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.|||Participants|||Number
1377102|NCT01485887|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who recieved at least one dose of the study drug.|||Participants|||Number
1377103|NCT01485796|Secondary|Number of Weeks to Reach Final 3 or 4-week Dose Interval|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|Of 36 participants treated with study drug in Epoch 2, 6 reached a final dose interval of 3 weeks and 30 reached a final dose interval of 4 weeks.|||weeks||Full Range|Median
1377104|NCT01485796|Secondary|Maximum Infusion Rate in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||mL/h||Full Range|Median
1377105|NCT01485796|Secondary|Duration of Infusion in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||hours||Full Range|Median
1377106|NCT01485796|Secondary|Number of Infusion Sites (Needle Sticks) Per Month in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||infusion sites (needle sticks)||Full Range|Median
1377107|NCT01485796|Secondary|Number of Infusions Per Month in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||infusions||Full Range|Median
1377108|NCT01485796|Secondary|Trough Levels of Immunoglobulin G (IgG)|IgG trough levels at the beginning of Study Epoch 1 (previous immunoglobulin treatment) and at the end of Study Epoch 2 were analyzed.|7 months (per subject)|At screening, data (ie, IgG trough levels) were available for analysis from 36 participants. At the end of Epoch 2, data were available for analysis from only 33 participants.|||g/L||95% Confidence Interval|Geometric Mean
1377109|NCT01485796|Secondary|Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20||7 months (per subject)||||subjects|||Number
1377110|NCT01485796|Secondary|Rate of All Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of adverse events per infusion was derived using a Poisson model.|7 months (per subject)||||adverse events||95% Confidence Interval|Number
1377111|NCT01485796|Secondary|Number of All Related Adverse Events (Excluding Infections)||7 months (per subject)||||adverse events|||Number
1377112|NCT01485796|Secondary|Rate of Related Local Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of related local adverse events per infusion was derived using a Poisson model.|7 months (per subject)||||adverse events||95% Confidence Interval|Number
1377113|NCT01485796|Secondary|Number of Related Local Adverse Events (Excluding Infections)||7 months (per subject)||||adverse events|||Number
1377114|NCT01485796|Secondary|Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks||6 months (per subject)||||subjects|||Number
1377115|NCT01485796|Secondary|Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2||6 months (per subject)||||subjects|||Number
1377116|NCT01485796|Primary|Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model.|7 months (per subject)||||adverse events||95% Confidence Interval|Number
1377117|NCT01485796|Primary|Number of Related Systemic Adverse Events (Excluding Infections)||7 months (per subject)||||adverse events|||Number
1377118|NCT01485640|Secondary|Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|18 months|Only 153 subjects who had baseline and at least one post-baseline assessments.|||units on a scale||Standard Deviation|Mean
1377119|NCT01485640|Primary|Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs|Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.|18 months|Safety Population - subjects who took at least one dose of study medication|||participants|||Number
1377120|NCT01485536|Primary|Overall Response Rate (ORR)|Percentage of participants with objective response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|Up to 12 cycles or 48 weeks|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis|||percentage of participants|||Number
1377121|NCT01485536|Primary|Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL)|Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|56 days|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis|||Participants|||Count of Participants
1377122|NCT01485380|Primary|Number of Participants With Changes in the Brains Default Mode Network.|Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states.|1.5hrs|All 17 participants were analyzed. Blood oxygen level depended (BOLD) signals during the awake (n = 16), unconscious (n = 16), and recovery (n = 15) states were included in the final data set.|||participants|||Number
1377123|NCT01485354|Secondary|Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)|This test is carried out by using a hand dynamometer that measures the grip strength of the individual in kilograms (used as a measure of force). Subjects are instructed to position the thumb on one handle of the dynamometer and the other fingers on the other handle of the dynamometer. The device measures the force generated by the subject using a power grip. The investigators computed the difference between the Grip Strength value at completion of the 3-week intervention and the Grip Strength value at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||kg||Standard Deviation|Mean
1377124|NCT01485354|Secondary|Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)|The Box and Block test is designed to assess manual dexterity in subjects with motor impairments. Subjects are asked to move small wooden blocks from one box to another, moving their stroke-affected arm over a divider between the two boxes. The output of the test is the number of blocks that the subject moves from one box to the other within a set amount of time (i.e. 1 min). Older adults who are otherwise healthy would typically move 60 to 70 blocks in 1 min. Hence, the range of the scale for older adults is 0 to 70. The investigators computed the difference between the Box and Block Test score at completion of the 3-week intervention and the Box and Block Test score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||number of blocks||Standard Deviation|Mean
1377125|NCT01485354|Secondary|Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)|The Functional Ability Scale is designed to assess the quality of movement during the performance of a battery of functional tasks. Therapists observe the subject while performing the motor tasks and use an ordinal scale to rate the quality of movement. The scale used to rate each motor task ranges from 0 to 5. The Functional Ability Scale is derived by adding up the scores for each motor task performed by the subject. Subjects perform 15 motor tasks. Hence the Functional Ability Scale score varies from 0 (very poor quality of movement) to 75 (physiological movement). The investigators computed the difference between the Functional Ability Scale score at completion of the 3-week intervention and the Functional Ability Scale score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||units on a scale||Standard Deviation|Mean
1377126|NCT01485354|Secondary|Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)|The Wolf Motor Function test is designed to assess the severity of functional limitations in stroke survivors. The scale is administered by asking subjects to perform a series of functional movements (e.g. reach for and pick up a paperclip). The outcome of the assessment is the average time needed to perform the motor tasks that are part of the assessment. The score ranges from 0 to 120 s (i.e. if the subject is unable to perform the task, the score for that task is set to 120 s). The investigators computed the difference between the Wolf Motor Function Test score at completion of the 3-week intervention and the Wolf Motor Function Test score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||sec||Standard Deviation|Mean
1377135|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Participants|||Number
1377127|NCT01485354|Primary|Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)|The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||units on a scale||Standard Deviation|Mean
1377128|NCT01485172|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.|Up to Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Percentage of participants|||Number
1377129|NCT01485172|Secondary|Responder Rate According to the Clinical Global Impression – Global Improvement (CGI-I) Scale|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Percentage of participants|||Number
1377130|NCT01485172|Secondary|Change From Baseline in the UPDRS Part I (Mentation)|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the on phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Score on a scale||95% Confidence Interval|Least Squares Mean
1377131|NCT01485172|Secondary|Change From Baseline in the Total UPDRS Score (Parts I-III)|"The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Score on a scale||95% Confidence Interval|Least Squares Mean
1377132|NCT01485172|Secondary|Change From Baseline in UPDRS Activities of Daily Living|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Score on a scale||95% Confidence Interval|Least Squares Mean
1377133|NCT01485172|Secondary|Change From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1377134|NCT01485172|Secondary|Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score|The responder rate is defined as the percentage of participants with a greater than or equal to (>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Percentage of Participants|||Number
1383258|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-4: Omalizumab vs. ICS|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent-to-treat|||Ratio||Standard Error|Mean
1377136|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Participants|||Number
1377137|NCT01485172|Secondary|Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Participants|||Number
1377138|NCT01485172|Primary|Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III – Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).|Baseline and Week 4 of the Maintenance Period (Study Week 17)|Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1377139|NCT01485094|Secondary|Daily Current Pain Intensity|"Participants recorded their current pain intensity score 3 times a day, using a 0 -10 (11 point) Numeric Rating Scale where a rating of 0 corresponded to No Pain and a rating of 10 to Pain as bad as you can imagine.~The daily current pain intensity reported was derived as the mean of the 3 current pain intensity assessments taken on the day from all participants in the treatment group.~The lower the value on the 11 point scale the less pain was reported on a treatment."|Baseline; Day 10|Intent-to-Treat.|||units on a scale||Standard Deviation|Mean
1377140|NCT01485094|Secondary|Change in painDETECT Grading From Baseline (Day -1) to End of Double-blind Treatment (Day 7)|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated between 0 and 38 for each participant. Participants with a score between 0 and 12 are graded as negative and having no neuropathic pain component. Scores between 19 and 38 result in a positive grading, in other words having presence of neuropathic component. Values from 13 to 18 result in participants being graded as having an unclear neuropathic component to their pain. The painDETECT questionnaire was first administered on Day-1 (baseline). The data reported is for before treatment start (Day -1) and the change from baseline on Day 7 (end of the double-blind period)."|Day 7 (end of double blind treatment)|Intent-to-treat. 5 participants did not complete the painDETECT questionnaire on Day 7. Two participants in both the placebo and pregabalin treatment arm and 1 in the GRT6010 treatment arm.|||participants|||Number
1377141|NCT01485094|Secondary|Difference in Leeds Sleep Evaluation Questionnaire After 7 Days of Treatment|"On the last day of the double-blind treatment period sleep was evaluated using the Leeds sleep evaluation questionnaire. This questionnaire has 10 self-rating 100 mm line analogue questions concerning sleep and early morning behavior. The higher the score, i.e. the closer the value is to 100 the worse the rating by the participant.~The 10 responses are grouped into 4 subscores:~The ease of getting to sleep.~The perceived quality of sleep.~The ease of awakening from sleep.~The integrity of behavior following wakefulness."|Day 7|Intention-to-treat. No responses were obtained from 2 participants, one in the placebo and one in the pregabalin treatment arm.|||units on a scale||Standard Deviation|Mean
1377142|NCT01485094|Secondary|Change in Area of Static Allodynia and Dynamic Allodynia From Baseline|"Allodynia is pain due to a stimulus that does not normally provoke pain. To measure the areas of dynamic and static allodynia, a point lying in the center of the area of maximum pain was marked at baseline (Day -2 and -1). From the baseline point, 8 radii were drawn.~The area of dynamic allodynia was determined by gently stroking the skin with a standardized brush along the lines. The participant was asked to report when the sensation became unpleasant.~The area of static allodynia was determined by a 128 mN (millinewton) pinprick stimulus along the lines of the 8 radii while asking the subject to report when the sensation became unpleasant.~The area was calculated from the summing of the 8 triangles that are generated from the points along each of the 8 radii at which unpleasantness was reported. The larger the area in square centimeters the more allodynia. A reduction in the area of allodynia indicates improvement."|Baseline; Day 7 (end of double blind treatment)|Intent-to-treat|||square centimeters||Standard Deviation|Mean
1377143|NCT01485094|Secondary|The Difference Between Baseline and End-of-double-blind Treatment Scores for Dynamic Mechanical Allodynia and Mechanical Pain Sensitivity Compared to Placebo|"Allodynia is pain due to a stimulus that does not normally provoke pain. Dynamic mechanical allodynia was assessed using a set of 3 light tactile stimulators as moving innocuous stimuli.~Each participant gave numerical pain ratings for each of 15 stimuli at the affected side.~Mechanical pain sensitivity was assessed using a set of 7 weighted pinprick stimuli to obtain the stimulus–response function for pinprick-evoked pain.~The participant gave a numerical pain ratings for each of 35 pinprick stimuli at the affected site.~Dynamic mechanical allodynia and mechanical pain sensitivity was calculated as the geometric mean of all numerical ratings. The values obtained on Day -2 and -1 were taken as the baseline and values on Day 6 and 7 were taken as the end of treatment. A negative change indicates an improvement on the 0 (no pain) to 100 point scale, where 100 indicates the worst imaginable pain."|Day 7 (end of double blind treatment)|Intention-to-treat|||units on a scale||Standard Deviation|Mean
1377144|NCT01485094|Secondary|Difference in Patient's Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the 7 day treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Day 7 (end of double blind treatment)|Intention-to-treat|||participants|||Number
1377145|NCT01485094|Secondary|Change in Neuropathic Pain Symptom Inventory Scores on Day 7 From Baseline (Day -1)|"The Neuropathic Pain Symptom Inventory (NPSI) Score is an assessment of neuropathic pain symptoms.~A participant answered 10 questions on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable).~The total NPSI score is the sum of all ten responses and ranges between 0 and 100.~The baseline score and the mean NPSI change is reported over the double-blind treatment period. A negative mean change in score on Day 7 indicates an improvement on this 0 to 100 point scale from baseline for the total score.~For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores a negative mean change indicate an improvement on the 11 point scale. A participant will score 10 to indicates the worst imaginable symptom, e.g. worst burning imaginable. A participant will score 0 if there is no burning, i.e. the symptom is absent."|Day -1; Day 7 (end of double blind treatment)|intent-to-treat|||units on a scale||Standard Deviation|Mean
1377146|NCT01485094|Secondary|Onset of Ongoing Pain Relief|"Onset of ongoing pain relief defined as the first time-point at which the participant reports a decrease of more than 1-point reduction in ongoing pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1. Study drug intake started on Day 1.~Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)|||||||
1377147|NCT01485094|Secondary|Onset of Current Pain Relief|"Onset of current pain relief defined as the first time-point at which the participant reports a decrease of a 1-point reduction in current pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1.~Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)|||||||
1377148|NCT01485094|Secondary|Assessment of Responder Rates|"The assessment was performed on Day 7.~The percentage of change from baseline (Day -3 to Day -1, i.e. the 3 days in the days prior to first dose) in the daily ongoing pain intensity was calculated at Day 7.~The percentage of change from baseline in the daily ongoing pain intensity was calculated at Day 7 as follows:~% change = (Baseline Pain Intensity - Daily pain intensity at treatment visit) / Baseline Pain Intensity × 100~The threshold values represent an improvement in ongoing pain intensity greater than 20, 30, 40, 50, 60, 70, 80 or 90% as per calculation.~Participants who showed a worsening in their daily pain intensity or who prematurely discontinued the trial were regarded as non-responders in terms of the respective treatment."|Day 7 (end of double blind treatment)||||participants|||Number
1377149|NCT01485094|Primary|The Difference Between Baseline and End-of-double-blind Treatment Brush-evoked Pain Intensity Scores|"The difference between baseline and end-of-double-blind treatment brush-evoked pain intensity scores compared to placebo on a 0-100 point NRS (measured as part of the dynamic mechanical allodynia assessments).~Each participant rated each brush-evoked pain intensity on a 0 to 100 point Numerical Pain Rating Scale, with 0 indicating ‘No Pain’ and 100 indicating ‘most intense pain imaginable’. Lower values compared to an individual subject’s baseline are an improvement in symptoms.~The baseline brush-evoked pain intensity score was defined as the average of the geometric mean of all of the values obtained on Day -2 and Day -1, and compared with the scores obtained on day 6 and 7.~For the analysis, only pain scores on days where participants received study drug were considered.~A negative change indicates a decrease in brush-evoked pain intensity from baseline."|Baseline and day 7 (end of double blind treatment)||||units on a scale||Standard Deviation|Mean
1377150|NCT01485094|Primary|Difference Between Baseline and End-of-double-blind Treatment Ongoing Pain Intensity Scores|The baseline pain intensity score was calculated as a mean of pain intensity scores during the Baseline Period (from Day -3 to Day -1). The ongoing pain intensity data from Day-3 to Day 7 was used. For the analysis, only pain scores on days where participants received study drug were considered. The primary efficacy analysis of the ongoing pain intensity score were analyzed in a Bayesian framework, via a mono exponential decay model, with the baseline Numeric Rating Score (NRS) as intercept. Considering the inclusion criteria of baseline pain intensity being in the range from 4 to 9, the range in ongoing pain intensity difference between baseline and end-of-double-blind treatment can be from 6 (worst possible value) to -9 (best possible value). A negative value indicates improvement whilst on the treatment.|Baseline; Day 7 (end of double blind treatment)|Intention-to-treat|||units on a scale||Standard Deviation|Mean
1377151|NCT01484977|Primary|Retention at the End of the 21-week Treatment Period|Retention is a summary measure that integrates both the patient’s and clinician’s assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.|Duration of the Treatment Period (21 Weeks)|The primary analysis consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.|||percentage of participants|||Number
1377152|NCT01484951|Secondary|Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy|As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.|Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.|||Percentage of Participants|||Number
1377153|NCT01484951|Primary|Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)|As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.|Baseline, Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.|||millimeters mercury (mmHg)||Standard Deviation|Mean
1377154|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.|||Units on a scale||Standard Deviation|Mean
1377155|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.|||Percentage of corneal staining||Standard Deviation|Mean
1377156|NCT01484912|Secondary|Consumption of Short-acting Nitrates||The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|The data was not available for analysis, because only two patients administered short-acting nitrates|||mg||Standard Deviation|Mean
1377157|NCT01484912|Secondary|Change in Pharmacological Parameters|The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.|baseline (visit 2) to week 6 (visit 5)|||||||
1377158|NCT01484912|Secondary|Change in Rate-pressure Product|Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.|baseline (visit 2) to week 6 (visit 5)|||||||
1377159|NCT01484912|Secondary|Change in Consumption of Short-acting Nitrates|The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|from baseline (visit 2) through week 6 (visit 5)|||||||
1377160|NCT01484912|Secondary|Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).|Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.|baseline (visit 2) through week 6 (visit 5)||||seconds||Standard Deviation|Mean
1377161|NCT01484912|Primary|Change in Total Exercise Time|Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.|baseline (visit 2) and week 6 (visit 5)||||seconds||Standard Deviation|Mean
1377162|NCT01484873|Secondary|Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)|Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks|baseline, 50 weeks||||minutes||95% Confidence Interval|Mean
1377163|NCT01484873|Secondary|Insulin Secretion (Area Under the Curve)|Change in insulin secretion from baseline|baseline, 50 weeks||||120 min*uU/mL x||95% Confidence Interval|Mean
1377164|NCT01484873|Secondary|Visual Analogue Scales for Post-meal Satiety|Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).|baseline, 50 weeks||||mm||95% Confidence Interval|Mean
1377165|NCT01484873|Secondary|Resting Energy Expenditure (Kcals Per Day)|Change in resting energy expenditure from baseline to 50 weeks|baseline, 50 weeks|8 patients completed the study but one patient did not have REE data available due to technical difficulties|||kcal/day||95% Confidence Interval|Mean
1377166|NCT01484873|Primary|Body Weight (kg)|Change in body weight from baseline to end of study|baseline, 50 weeks|Patients that completed the study|||kg||95% Confidence Interval|Mean
1377167|NCT01484834|Secondary|Pain Perception|"Pain perception were evaluated by the diagram of pain proposed by Corlett in 1995. The part of body which had pain were indicated by the participant. The data were analysed as yes or no and reported as Odds ratio."|The participants were followed for 3 months||||Odds Ratio||95% Confidence Interval|Number
1377168|NCT01484834|Secondary|Changes in Disease Prevalence|the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.|The participants were followed for 3 months||||participants||95% Confidence Interval|Number
1377169|NCT01484834|Secondary|Occupational Environment|The occupational environment was assessed by the quality of life questionnaire. (QVS-80). It considers physical aspects like accessibility and psycologic aspects such as stress. The domain consists of 11 questions about occupational environment. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months||||units on a scale 0-100||Standard Deviation|Median
1377170|NCT01484834|Secondary|Physical Activity Level|The level of physical activity was evaluated by the questionnaire of quality of life. (QVS-80). The physical activity domain is composed of 15 questions considering the ammount of physical activity practiced during leisure time. The instrument is structured in 5 points Lickert Scale. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months||||units on a scale||Standard Deviation|Median
1377171|NCT01484834|Primary|Quality of Life|The instrument contains 80 questions, of which 67 were structured in 5 points Lickert Scale. QVS-80 has four domains: Health Domain (Health) Physical activity (PA), occupational environment domain (AO) and perception of QoL (QOL). The health domain is composed of 30 questions, and the thirteen initial questions refer to history of the existence of chronic diseases such as hypertension, diabetes, obesity, dyslipidemias, bronchitis, allergic rhinitis and cancer; the remaining questions relate to lifestyle and living habits, such as quality of sleep, smoking and consumption of alcohol. The domain of physical activity consists of 15 questions on physical activity. The Domain workplace consists of 11 questions about the physical activity at work and occupational environment. The Domain perception of QoL consists of 24 questions about personal characteristics, and autonomy. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months||||units on a scale||Standard Deviation|Median
1377255|NCT01484028|Primary|Corneal Staining of Grade 3 or 4|Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.|After 7-9 days of lens wear|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.|||% of Eyes|eyes|95% Confidence Interval|Number
1377172|NCT01484652|Primary|SPID48 (Summed Pain Intensity Difference)|Pain intensity (PI) is measured using the 11-point (0-10) Numeric Pain Rating Scale (NPRS) score. PID is the arithmetic difference in NPRS score at the time point of interest from the baseline score. SPID48 is the sum of time-weighted PID scores measured 22 times over the 48 hour assessment period, with a total score ranging from -480 (worst) to 480 (best). A higher SPID value indicates greater pain relief.|48 hours|The analysis population for the primary outcome measure was the modified intent-to-treat population (mITT). The mITT analysis population includes 303 subjects from Cohort 2. Missing pain intensity difference scores were imputed using a multiple imputation method.|||scores on a scale||Standard Error|Mean
1377173|NCT01484626|Primary|Number of Patients Experiencing a Toxicity|The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.|21 days|No patients were analyzed as study was terminated early after external sponsor withdrew support. Therefore, data necessary for planned analyses were not collected.|||Participants|||Count of Participants
1377174|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 43 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
1377175|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
1377176|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 43 of Period 1|FAS|||score on a scale||Standard Error|Least Squares Mean
1377177|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 43 of Period 2, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
1377178|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
1377179|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 43 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
1377180|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 43 of Period 1, Day 29 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
1377181|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
1377182|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician’s response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 43 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
1377183|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in PGAA|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.|Day 43 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
1377184|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in PGAA|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.|Day 1 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
1377256|NCT01484028|Primary|Lens Fit Acceptance|The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.|||% of Eyes|eyes|95% Confidence Interval|Number
1377185|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)|Participants answered the following question, “Considering all the ways your arthritis affects you, how are you feeling today?” Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly.|Day 1 of Period 1, Day 43 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
1377186|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in CRP||Day 43 of Period 1, Day 29 of Period 2|FAS|||mg/L||Standard Error|Least Squares Mean
1377187|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in CRP||Day 1 of Period 1, Day 29 of Period 2|FAS|||mg/L||Standard Error|Least Squares Mean
1377188|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in CRP||Day 1 of Period 1, Day 43 of Period 1|FAS|||mg/L||Standard Error|Least Squares Mean
1377189|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS|||swollen joints||Standard Error|Least Squares Mean
1377190|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS|||swollen joints||Standard Error|Least Squares Mean
1377191|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS|||swollen joints||Standard Error|Least Squares Mean
1377192|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS|||tender/painful joints||Standard Error|Least Squares Mean
1377193|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS|||tender/painful joints||Standard Error|Least Squares Mean
1377194|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal [IP], PIP, and distal interphalangeals [DIP]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals [MTP], great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS|||tender/painful joints||Standard Error|Least Squares Mean
1377195|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
1377196|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
1377197|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS|||score on a scale||Standard Error|Least Squares Mean
1377198|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
1377199|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
1377200|NCT01484561|Secondary|Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])|DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS|||score on a scale||Standard Error|Least Squares Mean
1377201|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)|||percentage of participants|||Number
1377202|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)|||percentage of participants|||Number
1377203|NCT01484561|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥)20 percent (%) improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS, missing values while participant was still enrolled utilized last observation carried forward (LOCF) imputation while participants with missing values after a participant was discontinued from study participation (for any reason) were considered to be nonresponders (nonresponder imputation [NRI])|||percentage of participants|||Number
1377204|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in serum creatinine.|||fold change||90% Confidence Interval|Geometric Mean
1377205|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in serum creatinine.|||fold change||90% Confidence Interval|Geometric Mean
1377206|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in serum creatinine.|||fold change||90% Confidence Interval|Geometric Mean
1377207|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (Cockcroft-Gault).|||fold change||90% Confidence Interval|Geometric Mean
1377208|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (Cockcroft-Gault).|||fold change||90% Confidence Interval|Geometric Mean
1377209|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (Cockcroft-Gault).|||fold change||90% Confidence Interval|Geometric Mean
1377210|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS (OC); three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (MDRD).|||fold change||90% Confidence Interval|Geometric Mean
1377211|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (MDRD).|||fold change||90% Confidence Interval|Geometric Mean
1377212|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS (OC); one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (MDRD).|||fold change||90% Confidence Interval|Geometric Mean
1377213|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in mGFR.|||fold change||90% Confidence Interval|Geometric Mean
1377214|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR.|||fold change||90% Confidence Interval|Geometric Mean
1377215|NCT01484561|Primary|Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)|Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m^2) body surface area. A normal GFR is greater than (>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the test article (CP-690,550 or placebo). Observed Case (OC): missing data were not imputed. One participant was excluded (took wrong treatment) from FAS analysis of change at end of Period 1 from baseline in mGFR.|||fold change||90% Confidence Interval|Geometric Mean
1377216|NCT01484496|Secondary|Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline|For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).|Baseline (Day 0, prior to dosing), Weeks 40 through Week 52|ITT population. Only par. with Baseline prednisone dose >7.5 mg/day were included.|||Percentage of par.|||Number
1377217|NCT01484496|Secondary|Time to First Severe Flare (as Measured by the Modified SLE Flare Index)|Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date – treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.|Baseline (Day 0, prior to dosing) to Week 52|ITT population. Only those participants available at that particular timepoints were analyzed.|||Days||Full Range|Median
1377218|NCT01484496|Primary|Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52|SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).|Week 52|Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included.|||Percentage of par.|||Number
1377219|NCT01484314|Secondary|Incidence of Grade 3/4 Thrombocytopenic Events|To assess whether eltrombopag decreases the incidence of grade 3/4 thrombocytopenic events by day 1 of Cycle 3 of chemotherapy|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.||||||
1377220|NCT01484314|Primary|Safety and Tolerability|To determine whether eltrombopag administration results in an increased number of participants with adverse events.|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.||||||
1377221|NCT01484314|Primary|Maintenance of Platelet Count|To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at > 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.||||||
1377222|NCT01484197|Secondary|Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)||Day 1, Day 7|PK Analysis Set|||hour*pg/mL||Standard Deviation|Mean
1377223|NCT01484197|Secondary|Observed Maximum Concentration (Cmax) After Drug Administration||Day 1, Day 7|PK Analysis Set|||pg/mL||Standard Deviation|Mean
1377224|NCT01484197|Secondary|Time to Reach Maximum Concentration (Tmax) After Drug Administration||Day1, Day 7|PK Analysis Set|||Hours||Full Range|Median
1377225|NCT01484197|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section|Up to 101 days|Safety population inlcuded all participants who received at least one dose of study drug.|||Participants|||Number
1377226|NCT01484197|Secondary|Number of Puffs of Rescue Medicine|Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect.|Up to 101 days|Participants in the Pharmacodynamics Analysis set (included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement) who used rescue medication.|||Puffs/day||90% Confidence Interval|Least Squares Mean
1377227|NCT01484197|Secondary|Peak Expiratory Flow Rate in the Morning in the Evening|PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model.|Up to 101 days|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters per second||Standard Error|Least Squares Mean
1377228|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)|Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||90% Confidence Interval|Least Squares Mean
1377229|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)|Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||90% Confidence Interval|Least Squares Mean
1377230|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters/second||Standard Deviation|Mean
1377231|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters/second||Standard Deviation|Mean
1377232|NCT01484197|Secondary|FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Ratio||Standard Deviation|Mean
1377233|NCT01484197|Secondary|FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Ratio||Standard Deviation|Mean
1377234|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
1377335|NCT01483183|Primary|Part 2/1 Infusion: AUCt|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377235|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
1377236|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
1377237|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
1377238|NCT01484197|Secondary|Time to Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Hours||Full Range|Median
1377239|NCT01484197|Secondary|Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||90% Confidence Interval|Least Squares Mean
1377240|NCT01484197|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment|Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||Standard Error|Least Squares Mean
1377241|NCT01484197|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment|Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||Standard Error|Least Squares Mean
1377242|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 15 subjects who had BPA at 14 days after the second dental treatment were used.|||ng/mL||Standard Deviation|Mean
1377243|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 26 subjects who had BPA at 1 day after the second dental treatment were used.|||ng/mL||Standard Deviation|Mean
1377269|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Forward Flexion|Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377244|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 81 subjects who had BPA at 14 days after the first dental treatment were used.|||ng/mL||Standard Deviation|Mean
1377245|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 89 subjects who had BPA at 1 day after the first dental treatment were used.|||ng/mL||Standard Deviation|Mean
1377246|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG – 1)/(SG – 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at follow-up minus BPA at baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 6 months|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 77 subjects who had BPA at 6 months were used.|||ng/mL||Standard Deviation|Mean
1377247|NCT01484054|Primary|Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
1377248|NCT01484054|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
1377249|NCT01484054|Primary|Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
1377250|NCT01484041|Secondary|Progression-free Survival|Length of time from study entry until progressive disease|24 weeks|Data not collected for this outcome as study terminated by company prior to completing accrual||||||
1377251|NCT01484041|Secondary|Pharmacodynamic Effects|Expression of pFGFR, pFRS2, pERK in tumor tissue and VEGF, bFGF, PLGF, sVEGFR1/2 and FGF23 levels in plasma|24 weeks|Data were not collected for this outcome||||||
1377252|NCT01484041|Secondary|Number of Participants With Adverse Events|Number of participants experiencing adverse events|24 weeks||||participants|||Number
1377253|NCT01484041|Secondary|Recommended Phase 2 Dose|The dose of dovitinib at which 1 or less subjects experience a dose limiting toxicity when administered every day for 5 days followed by 2 days off schedule in combination with an aromatase inhibitor|4 weeks|Subjects on study evaluated for toxicity|||mg|||Number
1377254|NCT01484041|Primary|Clinical Benefit Rate|Complete response, partial response, or stable disease at 24 weeks from trial entry as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|24 weeks||||participants|||Number
1377331|NCT01483183|Primary|Part 2: Diastolic and Systolic Blood Pressure|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377257|NCT01484028|Primary|Monocular Visual Acuity|Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.|||LogMAR score|eyes|Standard Deviation|Mean
1377258|NCT01483963|Secondary|Investigator Assessment of Improvement With Treatment at Day 92|Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||Participants|||Count of Participants
1377259|NCT01483963|Secondary|Subject Satisfaction With Treatment at Day 92|Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.|Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||Participants|||Count of Participants
1377260|NCT01483963|Secondary|Change From Baseline to Day 92 in ASES Function Subscale|Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||units on a scale||Standard Deviation|Mean
1377261|NCT01483963|Secondary|Change From Baseline to Day 92 in ASES Pain Subscale|"Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant assessment of pain in response to How bad is the pain in your affected shoulder today? on an 11-point numerical rating scale (NRS) where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation"|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||units on a scale||Standard Deviation|Mean
1377262|NCT01483963|Secondary|Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score|Composite score ranging from 0-100, with 0 being worst pain and function loss, derived from the sum of the scores from pain subscale (11-point NRS where 0=no pain at all and 10=pain) and function subscale (activity questionnaire where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||units on a scale||Standard Deviation|Mean
1377263|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Internal Rotation|PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377264|NCT01483963|Secondary|Change From Baseline to Day 92 in Active Internal Rotation|AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377265|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive External Rotation|PROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377266|NCT01483963|Secondary|Change From Baseline to Day 92 in Active External Rotation|AROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377267|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Abduction|PROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377268|NCT01483963|Secondary|Change From Baseline to Day 92 in Active Abduction|AROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377332|NCT01483183|Primary|Part 2: Ventricular Rate|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377270|NCT01483963|Primary|Change From Baseline to Day 92 in Active Forward Flexion|Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
1377271|NCT01483937|Secondary|Head Shake Sensory Organization Test (HS_SOT)|"Head Shake Sensory Organization Test (HS-SOT)~HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis."|Pre Test, Post Test 1 and Post Test 4|||||||
1377272|NCT01483937|Secondary|Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4|Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.|Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days||||units on a scale||Standard Deviation|Mean
1377273|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2|"Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment.~Scoring: A five-point ordinal scale, ranging from 0-4. “0” indicates the lowest level of function and “4” the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling.~Criterion Validity: “Authors support a cut off score of 45/56 for independent safe ambulation”.~Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 –20 = high fall risk~Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded:~Sensitivity = 64% (Correctly predicts fallers)~Specificity = 90% (Correctly predicts non-fallers)"|Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.||||percentage of participants|||Number
1377274|NCT01483937|Secondary|Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1|A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)|Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days||||percentage of participants|||Number
1377275|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2|"Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where 0 indicates the lowest level of function and 3 the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling.~Criterion Validity: “Authors support a cut off score of 23/30 for independent safe ambulation”.~Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders.~3) 23-30 = safe ambulators"|Pre Test to Post Test 2 after four physical therapy sessions within 10 days||||percentage of participants|||Number
1377276|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)||||units on a scale||Standard Deviation|Mean
1377277|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)||||units on a scale||Standard Deviation|Mean
1377278|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)||||units on a scale||Standard Deviation|Mean
1377279|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Pre Test to Post Test 1 after two physical therapy sessions (one week)||||units on a scale||Standard Deviation|Mean
1377280|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score|In the PGA, the physician assigns a single estimate of a patient’s overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1377281|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System–Physician Global Assessment (LS-PGA) Scores|The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51–100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from “none” to “marked”; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1377282|NCT01483924|Secondary|Efficacy of APO805K1 as Assessed by Achievement of PASI-75|The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12|12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||percentage of patients|||Number
1377283|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores|PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 Weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1377284|NCT01483924|Secondary|T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14|T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)|||hour||Standard Deviation|Mean
1377285|NCT01483924|Secondary|AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14|AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)|||ng *hr/mL||Standard Deviation|Mean
1377286|NCT01483924|Secondary|Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours||||hour||Full Range|Median
1377287|NCT01483924|Secondary|Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)|||ng/mL||Standard Deviation|Mean
1377288|NCT01483924|Primary|Number of Patients With Adverse Events|The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.|12 Weeks|The Safety Population consisted of all patients who received at least 1 dose of study medication.|||participants|||Number
1377289|NCT01483820|Secondary|To Evaluate the Drug Levels and Pharmacokinetics (PK) of TPI 287 From Blood Samples at Multiple Time Points Within the First 24 Hours on Study.|To evaluate the pharmacokinetics (PK) of TPI 287 in the Phase I population of this trial.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
1377290|NCT01483820|Secondary|Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|To evaluate the impact of QOL of children receiving TPI287 using PedsQL questionnaires|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
1377291|NCT01483820|Secondary|Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|3 years|Not evaluated due to early closure. Study data does not exist.||||||
1377292|NCT01483820|Secondary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years||||Days|||Number
1377293|NCT01483820|Secondary|Number of Participants With Overall Response Assessed Using RECIST Criteria|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||participants|||Number
1377294|NCT01483820|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Phase I portion of trial- To determine the safety and tolerability of TPI 287 as a single agent in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma. Adverse events collected from time of first dose to 30 days past last dose and until all related events resolved, average of one year.|length of study +30 days||||participants|||Number
1377295|NCT01483651|Primary|Area Under the Curve for Glucose Above Baseline|The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production [mg/kg/min] measured over time [min]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.|60 minutes after each glucagon administration||||mg/kg glucose per mcg glucagon||Standard Deviation|Mean
1377296|NCT01483625|Secondary|Weekly Rescue Medication Use Over the 12 Weeks of Study|Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.|12 weeks|TS with non missing rescue medication use.|||puffs||Standard Deviation|Mean
1377297|NCT01483625|Secondary|Responder Status at Week 12 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:~Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).~Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).~Subject did not recover."|12 weeks|TS with non missing responder data at week 12. Responder defined by >= 20% improvement. .|||participants|||Number
1377298|NCT01483625|Secondary|Responder Status at Week 4 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:~Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).~Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).~Subject did not recover."|4 weeks|Responder defined by >= 20% improvement. TS with non missing responder data.|||participants|||Number
1377299|NCT01483625|Secondary|Trough FVC (in Litres) at 12 Weeks|The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|TS with non missing FVC data.|||Litres||Standard Deviation|Least Squares Mean
1377300|NCT01483625|Secondary|Time to Recovery From Acute Respiratory Symptoms|"Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations.~The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation.~The EXACT-PRO was answered by the patients on a daily basis in the evening."|12 weeks|TS with non missing EXACT-PRO data.|||units on a scale||Standard Deviation|Geometric Mean
1377301|NCT01483625|Primary|Trough FEV1 After 12 Weeks on Study Drug|The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|Treated Set (TS) with non missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
1377302|NCT01483599|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline and Week 16|Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1377303|NCT01483599|Secondary|Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40|PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 40|Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure. The placebo reporting group was not planned to be analyzed in this outcome measure.|||percentage of participants|||Number
1377304|NCT01483599|Secondary|Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16|PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 16|Population analyzed included all participants who were randomized.|||percentage of participants|||Number
1377305|NCT01483599|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.|Week 16|Population analyzed included all participants who were randomized.|||percentage of participants|||Number
1377333|NCT01483183|Primary|Part 2: QTcF|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377306|NCT01483599|Primary|Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16|PGA of psoriasis is used to determine the participant’s psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 16|Population analyzed included all participants who were randomized.|||percentage of participants|||Number
1377307|NCT01483378|Primary|Answers to Survey Questions|All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.|January 9, 2012 to February 12, 2012||||Percentage of responders||95% Confidence Interval|Number
1377308|NCT01483352|Secondary|Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response|The participant questionnaire consisted of two parts including description of routine operations, followed by 23 questions used to determine the following: percentage of participants needing consultation of instructions for use of fixation disc or infusion set; percentage of participants with pain after implantation, percentage of participants with moderate pain during 4 to 6 days after implantation, moderate pain for 7 days or more; percentage of participants with temporal disconnection from infusion set; percentage of participants with use of handling aid for temporal storage; percentage of participants with a reason for temporal disconnection of infusion set from port either sex, shower, or sport; percentage of participants changing fixation disc ≥3 days or infusion set ≥4 days and the cartridge, and percentage of participants cleaning the skin around the port daily, every second day, or every third to fifth day, either with saline during healing or with alcohol after healing.|Week 12|All participants were included in the analysis.|||percentage of participants|||Number
1377309|NCT01483352|Secondary|Percentage of Participants Achieving Target Glucose Levels|Target glucose values were 70-180 mg/dL. Participants with glucose levels below 70 mg/dL were considered to be under target and those above 180 mg/dL were considered over target. The mean of Glucose-Measurements at the visit date was calculated as follows: a variable was created for each category (“within target [70-180 mg]”, “below target” and “above target”) that tells if the value lies within this category. Then the percentage per participant and visit was calculated. The mean represents the mean of these percentages per participant at the visit.|Screening, Week 12 and 6 Months|All participants were included in the study; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants||Standard Deviation|Mean
1377310|NCT01483352|Secondary|Glycemic Variability: Percent Coefficient of Variation in Blood Glucose|Both self monitored (SMBG) and continuous (CGM) glucose measurements were used to determine the coefficient of variation in blood glucose. CGM data are only evaluated for a 1 week time period and are no direct comparison to the SMBG that reflect the full time frame between visits.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percent of mean glucose value||Standard Deviation|Mean
1377311|NCT01483352|Secondary|Continuous Glucose Measurement (CGM) - Glucose Levels|CGM measurements were performed using a diurnal CGM sensor and group means were calculated over 10 minute periods of the CGM measurements.|Screening, Week 12 and 6 Months|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||mg/dL||Standard Deviation|Mean
1377312|NCT01483352|Secondary|Self Monitored Blood Glucose Levels|Participants monitored glucose levels on a daily basis and recorded for evaluation. Glucose levels are measured as milligrams per deciliter (mg/dL)|Screening, Week 12 and Months 6, 9 and 12|All participants were included in analysis; n= number of participants analyzed for the given parameter at the specified time point|||mg/dL||Standard Deviation|Mean
1377313|NCT01483352|Secondary|Hemoglobin A1c Levels|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. HbA1c levels are a measure of glycemic control.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percent of glycated hemoglobin||Standard Deviation|Mean
1377314|NCT01483352|Secondary|Insulin Doses Dispensed From Insulin Pump|Total insulin dose (in international units per milliliter [IU/mL]) from pump was measured per day as mean per day measured over 7 days.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||IU/mL||Standard Deviation|Mean
1377315|NCT01483352|Primary|Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally|Problems in ability to deliver insulin intraperitoneally was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
1377316|NCT01483352|Primary|Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant|Signs of infection/allergic reaction at the site of implant was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
1377334|NCT01483183|Primary|Part 2/2 Infusions: AUCt|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377317|NCT01483352|Primary|Percentage of Participants With Persistent Dull Pain Due to Catheter|Pain due to catheter was determined by a participant questionnaire and categorized as follows: Category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5= Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
1377318|NCT01483352|Primary|Percentage of Participants With Signs of Pain in the Tissue Around the Port|Signs of pain was determined from the participant questionnaire which was categorized as follows: category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5=Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
1377319|NCT01483352|Primary|Percentage of Participants With Signs of Infection in the Tissue Around the Port|Signs of infection were determined by the physician and categorized as follows : Category 1= None; 2= Minor, negligible; 3= Some, noticeable 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
1377320|NCT01483352|Primary|Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port|Signs of Redness/Swelling was determined by the physician and was categorized as follows: Category 1= None; 2= Minor, negligible; 3= Some, noticeable; 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
1377321|NCT01483352|Primary|Percentage of Participants With Dislocation of Port|Position of the port was determined by the physician and was categorized as follows: Category 1= No dislocation; 2= Minimal dislocation; 3= Clearly visible dislocation, with minimal impairment of function; 4= Dislocation impairs functions; 5= Dislocation results in disabling functions. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
1377322|NCT01483352|Primary|Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin|Mechanical stability of the device was determined by the stability of the ingrowth surrounding the port as determined by the physician. The ingrowth problems are categorized as follows: Category 1= complete stable Ingrowth, 2= Ingrowth working with negligible problems, 3= Ingrowth working with some problems, 4= Ingrowth working with major problems and 5= Ingrowth resulting in almost non-functional port. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the study; number (n)= number of participants analyzed for the given parameter at the specified timepoint|||percentage of partcipants|||Number
1377323|NCT01483352|Primary|Suitability of the Device - Overall Suitability Score|Suitability of the device was assessed by the investigator using a questionnaire that determined the following: 1) condition of the tissue around the port: tight connection between port and skin (mechanical stability, dislocation of port, signs of redness/swelling, infection, or pain), 2) peritoneal reactions (persistent dull pain due to catheter, signs of infection/allergic reaction) and ability to deliver insulin intraperitonally at every visit after implantation. Suitability score was determined using participant's responses to a questionnaire where 1 equals (=) no problem, 2=minor/negligible problems, 3=some/noticeable problems, 4=major/cumbersome and 5=severe/almost unbearable problems. Each question was scored and an average across the questions was determined as an overall score. The scores ranged from 1 (not at all suitable) to 5 (completely suitable).|Week 12|All participants who received the implant were included in the analysis.|||units on a scale||Standard Deviation|Mean
1377324|NCT01483209|Secondary|Digital Amputations|The number of digits amputated in our patient cohort is a secondary endpoint of this study. We will use a paired t-test to compare the number of digital amputations in the control versus experimental group.|12 months|Due to insufficient accrual, data analysis was not performed.||||||
1377325|NCT01483209|Primary|Perfusion (as Determined by Laser Doppler Measurements)|A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).|12 months|Due to insufficient accrual, data analysis was not performed.||||||
1377326|NCT01483183|Secondary|Part 2: Duration of NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|168 hours|||||||
1377327|NCT01483183|Secondary|Part 2: Duration of NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377328|NCT01483183|Secondary|Part 2: Time to NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377329|NCT01483183|Secondary|Part 1: Percentage of Participants With NSR|Percent of participants with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion.|30 minutes|Safety dataset included all participants who had received at least one dose of the trial medication.|||percentage of participants|||Number
1377330|NCT01483183|Primary|Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR)|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377336|NCT01483183|Primary|Part 2/2 Infusions: Cmax|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377337|NCT01483183|Primary|Part 2/1 Infusion: Cmax|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
1377338|NCT01483183|Primary|Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion|Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic <100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.|||mmHg||Standard Deviation|Mean
1377339|NCT01483183|Primary|Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion|12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.|||beats/minute||Standard Deviation|Mean
1377340|NCT01483183|Primary|Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion|12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.|||msec||Standard Deviation|Mean
1377341|NCT01483183|Primary|Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ)|OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion.|24 hours|PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.|||μg∙h/mL||Standard Deviation|Mean
1377342|NCT01483183|Primary|Part 1: Maximum (Peak) Plasma Concentration (Cmax)|OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion.|24 hours|PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.|||μg/mL||Standard Deviation|Mean
1377343|NCT01483118|Secondary|Change in Glucose Response|Change in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion.|Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion||||mg/dL*min||Inter-Quartile Range|Median
1377344|NCT01483118|Secondary|Change in Insulin Resistance|The changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of >2 is considered healthy for adults with scores >5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes).|Baseline and 6 months||||Insulin sensitivity indices||Inter-Quartile Range|Median
1377345|NCT01483118|Primary|Number of Menses During the Six Month Study Period.|Ovulatory cycles will be confirmed by serum progesterone levels.|Up to 6 months||||Number of menstrual cycles per month||Inter-Quartile Range|Median
1377346|NCT01482962|Secondary|Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms|The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better well-being and a positive change from Baseline indicates improvement.|Baseline and End of Treatment (EOT) (Up to 152 Weeks)|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||score on a scale||Standard Deviation|Mean
1377347|NCT01482962|Secondary|Plasma Concentration-time Data to Contribute to Future Population Pharmacokinetics (PK) Analysis||Cycle 1, Days 1 and 7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration is approximately 4 months.|This Outcome Measure was registered in error and is not a Primary or Secondary Outcome Measure.||||||
1377348|NCT01482962|Secondary|Time to Subsequent Antineoplastic Therapy|Time to subsequent antineoplastic therapy was defined as the time from randomization to the first date of subsequent antineoplastic therapy (excluding transplant). Participants without subsequent antineoplastic therapy were censored at the date of death or last known to be alive.|From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
1377349|NCT01482962|Secondary|Time to Response|Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.|||days||95% Confidence Interval|Median
1377350|NCT01482962|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.|||days||95% Confidence Interval|Median
1377351|NCT01482962|Secondary|Time to Disease Progression (TTP)|Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
1377352|NCT01482962|Secondary|Complete Response (CR) Rate|Complete Response (CR) rate is defined as the percentage of participants with CR as assessed by the IRC using IWG criteria (2007 Cheson). CR= Disappearance of all evidence of disease.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until PD (approximately 3 years)|Response-evaluable population was defined as participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at baseline, who receive at least 1 dose of alisertib or the comparator drug, and 1 postbaseline response assessment of CR, PR, SD or PD by the independent radiology committee.|||percentage of participants||95% Confidence Interval|Number
1377353|NCT01482962|Secondary|Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs|Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.|First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)|Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.|||participants|||Number
1377354|NCT01482962|Secondary|Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs|Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.|First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)|Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.|||participants|||Number
1377355|NCT01482962|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/ birth defect or is a medically important event.|First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)|Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.|||participants|||Number
1377356|NCT01482962|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death. Participants without documentation of death were censored at the date last known to be alive.|Participants were followed for survival for 2 years from date of last participant off study treatment, or death, whichever occurs first. Contacts were every 4 months (Median follow-up 519 days in the alisertib arm and 586 days in the comparative arm)|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
1377357|NCT01482962|Primary|Progression-Free Survival (PFS) Based on IRC Assessment|PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first.|Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|Intent-to-treat (ITT) population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
1377375|NCT01482767|Secondary|Number of Participants With Grade 2 or Higher Signs and Symptoms and Laboratory Abnormalities and Other Serious AEs|This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted. Refer to Outcome Measure 2 above for the safety outcome that includes the whole study duration from entry to week 72.|From study treatment dispensation to Week 28|This outcome measure was intended for a potential interim analysis which was not conducted.||||||
1383259|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-5:Omalizumab vs. Placebo|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent–to-treat|||Ratio||Standard Error|Mean
1377358|NCT01482962|Primary|Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment|ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.|Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|Response-evaluable population, participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at Baseline, who received at least 1 dose of alisertib or comparator and had postbaseline response assessment of CR, PR, stable disease (SD) or progressive disease (PD) by the IRC.|||percentage of participants||95% Confidence Interval|Number
1377359|NCT01482910|Secondary|Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 – LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|At week 28|Full analysis set|||Percentage of participants|||Number
1377360|NCT01482910|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 – Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline and at week 28|Full analysis set|||Letters correctly read||Standard Deviation|Mean
1377361|NCT01482884|Secondary|Immunogenicity|Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.|Pre-dose sampling at baseline, Week 8, 12, 16, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.|||participants|||Number
1377362|NCT01482884|Secondary|Serum Concentration of Tralokinumab||Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.|||ug/ml||Full Range|Mean
1377363|NCT01482884|Secondary|Change From Baseline in Calprotectin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||ug/g||Full Range|Mean
1377364|NCT01482884|Secondary|Change From Baseline in Albumin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||g/L||Full Range|Mean
1377365|NCT01482884|Secondary|Change From Baseline in C - Reactive Protein||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||mg/L||Full Range|Mean
1377366|NCT01482884|Secondary|Change From Baseline in Modified Riley Score|Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.|||Grade on scale||Standard Error|Least Squares Mean
1377367|NCT01482884|Secondary|Change From Baseline in Partial Mayo Score|The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician’s global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.|From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||Score on scale||Full Range|Mean
1377368|NCT01482884|Secondary|Clinical Remission at Week 8 Based on Mayo Score|Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants|||Percentage of participants|||Number
1377369|NCT01482884|Secondary|Mucosal Healing at Week 8 Based on Mayo Score|Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.|Eight week treatment period|The full analysis set consist of all randomised participants|||Percentage of participants|||Number
1377370|NCT01482884|Secondary|Change in Mayo Score From Baseline to Week 8|Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.|||Score on scale||Standard Error|Least Squares Mean
1377371|NCT01482884|Primary|Clinical Response at Week 8 Based on Mayo Score|Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician’s global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants|||Percentage of responders|||Number
1377372|NCT01482819|Primary|Endothelia Blebs|0 to 100% of area; measured as a percentage of corneal area with blebs.|after 20 minutes of lens wear|Subjects who were enrolled, randomized and completed the study.|||percentage of area|eyes|Standard Deviation|Mean
1377373|NCT01482819|Primary|Limbal Redness|grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study.|||units on a scale|eyes|Standard Deviation|Mean
1377374|NCT01482819|Primary|Corneal Swelling|measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured.|||microns|eyes|Standard Deviation|Mean
1383297|NCT01430130|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months|||||||
1377376|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 16, 20, 24 and 28 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted.|Weeks (W) 16, 20, 24, and 28|This outcome measure was intended for a potential interim analysis which was not conducted.||||||
1377377|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0.|Weeks (W) 4, 8, 12|All eligible participants with HCV RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.|||participants|||Number
1377378|NCT01482767|Secondary|CD4+ T-Cell Count (CD4) Change From Baseline|Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry.|Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants enrolled with CD4 result available from entry and the respective post-entry visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.|||cells/mm^3||Inter-Quartile Range|Median
1377379|NCT01482767|Secondary|Percentage of Participants With HIV-1 Viral Load <50 Copies/mL|HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL).|Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants with HIV-1 RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.|||percentage of participants|||Number
1377380|NCT01482767|Secondary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)|SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12.|12 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).|||percentage of participants||95% Confidence Interval|Number
1377381|NCT01482767|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)|Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|From study treatment dispensation to Week 72|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).|||percentage of participants||95% Confidence Interval|Number
1377382|NCT01482767|Primary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)|SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24.|24 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).|||percentage of participants||95% Confidence Interval|Number
1377383|NCT01482429|Primary|Length of Intensive Care Unit Stay||days|||||||
1377384|NCT01482429|Primary|Duration of Mechanical Ventilation||days|||||||
1377385|NCT01482429|Primary|Duration of Weaning From Mechanical Ventilation||days|overall|||days||Standard Deviation|Mean
1377386|NCT01482429|Primary|Mortality||length of ICU stay (days)|Overall|||participants|||Number
1377387|NCT01482325|Primary|Data Collection for Engineering Development|"This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely.~Software iterations are not pre-defined."|After each iteration of software development|Subject analysis was not performed because study was prematurely terminated. Work on the project ceased when it was terminated.The study was intended to have the engineers review data produced by each blood pressure determination to work on new software algorithm in development. This was not and will not be conducted.||||||
1377388|NCT01482312|Primary|Ocular Comfort|Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.|90 minutes|As treated.|||cm|Participants|Standard Deviation|Median
1377389|NCT01482312|Primary|Tear Osmolarity|The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.|90 minutes|As treated.|||mOsms/L|Participants|Standard Deviation|Mean
1377401|NCT01482221|Primary|Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline to Week 6|The modified intent-to-treat (mITT) analysis set included all randomized patients, who took investigational product (IP) and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
1377390|NCT01482221|Secondary|Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score|A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
1377391|NCT01482221|Secondary|Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of “Very Much Improved” or “Much Improved”) at Week 12|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
1377392|NCT01482221|Secondary|Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of “Very Much Improved” or “Much Improved”) at Week 6|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
1377393|NCT01482221|Secondary|Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score|Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient’s illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
1377394|NCT01482221|Secondary|Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score|A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
1377395|NCT01482221|Secondary|Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12|The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
1377396|NCT01482221|Secondary|Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6|The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
1377397|NCT01482221|Secondary|Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12|The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
1377398|NCT01482221|Secondary|Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6|The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
1377399|NCT01482221|Secondary|Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)|The percentage of patients with with Sustained Response (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.|Week 6 to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
1377400|NCT01482221|Secondary|Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline to Week 12|The modified intent-to-treat (mITT) analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
1377402|NCT01482169|Secondary|Duration to Baseline Hyperemia After Aminophylline Injection|In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection|seconds|Of the 48 patients enrolled, 7 of the patients did not have measurements for the secondary outcome.|||seconds||Standard Deviation|Mean
1377403|NCT01482169|Primary|Comparing Measurement of Fractional Flow Reserve (FFR)|For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.|DAY 1||||FFR||Standard Deviation|Mean
1377404|NCT01482091|Secondary|Hypoxia|Number of participants who had hypoxia within 30 min of study drug adminsitration|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
1377405|NCT01482091|Secondary|Hypotension|Participants who had hypotension within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
1377406|NCT01482091|Secondary|Respiratory Distress|Participants who had respiratory distress within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
1377407|NCT01482091|Secondary|Change in Pain Score|Due to confounding factors we were unable to obtain reliable data for this outcome|Baseline and immediately prior to IV insertion|||||||
1377408|NCT01482091|Secondary|Change in Pain Score at 30 Minutes|"Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points."|Baseline and 30 minutes after administration of study drug||||units on a scale||Inter-Quartile Range|Median
1377409|NCT01482091|Secondary|Change in Pain Score at 10 Minutes|"Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points."|Baseline and 10 minutes after administration of study drug||||units on a scale||Inter-Quartile Range|Median
1377410|NCT01482091|Secondary|Time to Study Drug Administration||Time from triage to adminstration of study drug||||minutes||Standard Deviation|Mean
1377411|NCT01482091|Secondary|Total Amount of Narcotics Administered|Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure|Participants will be followed for the duration of their ED visit, an expected average of 6 hours|||||||
1377412|NCT01482091|Secondary|Length of Stay in ED|Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure|Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours|||||||
1377413|NCT01482091|Secondary|Admission Rate||This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage||||participants|||Number
1377414|NCT01482091|Secondary|Presence of Headache||Participants will be followed for the duration of their ED visit, an expected average of 6 hours||||participants|||Number
1377415|NCT01482091|Secondary|Presence of Bradycardia|Number of participants who had bradycardia|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
1377416|NCT01482091|Primary|Change in Pain Score 20 Minutes After Administration of Study Drug|"Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points."|Baseline and 20 minutes after administration of study drug||||units on a scale||Inter-Quartile Range|Median
1377417|NCT01482065|Secondary|MRI Indices||6 Months|We were not able to obtain MRI data from 2 people within the CPAP group at 6 months. One withdrew from study and the other a clear scan could not be obtained.|||percentage of fat in liver||Standard Deviation|Mean
1377447|NCT01481779|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|Baseline, 26 weeks, 52 weeks, 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1377418|NCT01482065|Secondary|Analysis of Variance (ANOVA) in CPAP Versus No-CPAP Therapy on NAFLD|we will test our hypothesis that CPAP therapy improves NAFLD. The main independent variables will be CPAP vs. deferred-CPAP therapy. In a subanalysis, responses in the CPAP treatment group will be compared based on compliance. Compliance with CPAP is defined as using it on > 70% of the days, at least 4 h per night. Our primary outcome will be serum activity of ALT and AST. We will use ANOVA to examine changes in ALT and AST depending on CPAP therapy group and compliance. Secondary outcomes will include the degree of hepatic steatosis and fibrosis, as assessed by MRI.|6 months|We were unable to achieve enrollment goals due to limited clinical indications. Thereby not obtaining enough participant data to do an Analysis of Variance (ANOVA).||||||
1377419|NCT01482065|Secondary|Liver Values|Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) activity.|6 Months|Withdrawal by subject in CPAP group.|||U/L||Standard Deviation|Mean
1377420|NCT01482065|Primary|Cross Sectional Analysis of NAFLD Versus Sleep Apnea Severity Indices (AHI)|Cross-sectional analysis will be performed in NAFLD study participants from the Johns Hopkins (JH) Hepatology Clinic to examine the relationship between findings on liver biopsy and sleep apnea severity indices. The main predictor variable will be presence/severity of OSA and nocturnal oxyhemoglobin desaturation (assessed by T90%, time w/ oxyhemoglobin desaturation < 90%; Delta SaO2 between baseline and minimal oxyhemoglobin saturation, and standard deviation of nocturnal SaO2). Our primary outcome will be NAFLD activity score on biopsy.|6 months|We were unable to obtain liver biopsy on most of our participants due to limited clinical indications.||||||
1377421|NCT01481935|Primary|Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii|Swabs will be collected from the disposable gown and gloves of healthcare workers exiting the enrolled room. A single swab will be used for both gloves and the gown. The swab will be assayed for methicillin-resistant Staphylococcus aureus, multi-drug-resistant Acinetobacter baumannii, or both, depending on which organism(s) the occupant of the enrolled room is colonized with. The swab will be considered positive if the relevant organism is isolated. We will sample the first 15 healthcare worker exits after the room has received the allocated intervention.|As a healthcare worker exits the enrolled room (1 day)|Unit of analysis was the ICU room. Results from multiple participants who occupied a single room over the course of the trial were summarized by room.|||percentage of positive cultures|Participants|Standard Error|Mean
1377422|NCT01481896|Secondary|Patient Satisfaction Per Hip|Whether or not an individual is satisfied with the outcome of their hip arthroplasty is evaluated using a questionnaire. Since a participant with both hips replaced could have a different level of satisfaction for each hip, patient satisfaction is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty||||number of participants|Participants||Number
1377423|NCT01481896|Secondary|Component Revision Per Hip|For implants that require a component revision, the reason for the revision is determined based on the pre-operative history and operative findings at the time of revision. Since a participant with both hips replaced could have a revision of each hip, component revision is reported per hip.|At a mean of 6.7 years after primary total hip arthroplasty||||number of hips|Participants||Number
1377424|NCT01481896|Secondary|Implant Stability Per Hip|Implant stability is classified and stable/bone ingrown, fibrous fixed or loose and evaluated using conventional radiographs. Since a participant with both hips replaced could have a different type of stability for each hip, implant stability is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|All hips that had a follow-up x-ray taken at least 4.75 years after their joint replacement were included.|||number of hips|Participants||Number
1377425|NCT01481896|Secondary|Osteolysis Per Hip|Osteolysis is defined as localized areas of peri-prosthetic bone loss that did not exist prior to surgery and is evaluated using radiographs and CT scans. Since a participant with both hips replaced could have a osteolysis present or absent for each hip, osteolysis is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|Patients who had radiographs or computed tomography (CT) scans taken as part of routine care were included.|||Number of hips with osteolysis|Participants||Number
1377426|NCT01481896|Secondary|Harris Hip Score Per Hip|Harris Hip Scores are derived from a patient questionnaire and physical examination. Since a participant with both hips replaced could have different Harris Hip Scores for each hip, the Harris Hip Scores are reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty||||units on a scale|Participants|Full Range|Median
1377427|NCT01481896|Secondary|Cup Orientation Per Hip|Cup orientation including abduction and anteversion is determined using follow-up radiographs. Since a participant with both hips replaced could have different cup orientations for each hip, cup abduction and anteversion angles are reported per hip.|On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty|Cup orientation was measured for all 131 total hip replacements included in the study population.|||degrees|Participants|Full Range|Median
1377428|NCT01481896|Primary|Metal Ion Levels Per Participant|Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced.|At a mean of 4.2 years after primary total hip arthroplasty|Patients who had blood drawn and analyzed for serum cobalt levels as part of routine care are included.|||micrograms per liter||Full Range|Median
1377429|NCT01481779|Secondary|Rapid Assessment of Physical Activity (RAPA)|The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant’s amount and intensity of physical activity, allowing each participant’s aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants’ physical activities that increase strength and improve flexibility. Each participant’s strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.|26 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
1377430|NCT01481779|Secondary|European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA, adjusting for treatment and stratification factors (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline EQ-5D score as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1377431|NCT01481779|Secondary|Low Blood Sugar Survey (LBSS)|LBSS (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1377432|NCT01481779|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline value of the dependent variable as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1377433|NCT01481779|Secondary|Percentage of Participants With Change in Anti-LY2605541 Antibodies|The percentage of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable or from detectable to the value with at least 130% relative increase from baseline.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||percentage of participants|||Number
1377434|NCT01481779|Secondary|Lipid Profile|Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM, adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL] except for the LDL-C outcome variable), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1377435|NCT01481779|Secondary|Basal, Bolus, and Total Insulin Dose|Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units/kg/day||Standard Error|Least Squares Mean
1377436|NCT01481779|Secondary|Change From Baseline in Body Weight|LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.|Baseline and 26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
1377437|NCT01481779|Secondary|9 Point Self-monitored Blood Glucose (SMBG)|9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the pre-morning meal the next day. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1377448|NCT01481779|Secondary|Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1377438|NCT01481779|Secondary|0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion|Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1377439|NCT01481779|Secondary|Fasting Blood Glucose (FBG) Intra-participant Variability|FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1377440|NCT01481779|Secondary|Fasting Serum Glucose (FSG) by Laboratory Measurement|LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1377441|NCT01481779|Secondary|Percentage of Participants With Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
1377442|NCT01481779|Secondary|Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
1377443|NCT01481779|Secondary|Percentage of Participants With Total Hypoglycemia Events|Hypoglycemic events are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
1377444|NCT01481779|Secondary|Total Hypoglycemia Rates (Adjusted by 30 Days)|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
1377445|NCT01481779|Secondary|Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, then multiplying by 100.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method.|||percentage of participants|||Number
1377446|NCT01481779|Secondary|Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)|HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
1377624|NCT01479478|Secondary|"Count of Neonates Requiring a Rule-out Sepsis Evaluation"|Outcome was based on performance of neonatal blood culture.|Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377449|NCT01481779|Primary|Hemoglobin A1c (HbA1c) at 26 Weeks|HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol [LDL-C] [<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1377450|NCT01481740|Secondary|Neonatal Acidosis||intraoperative||||pH value||Standard Deviation|Mean
1377451|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - postdelivery||||participants|||Number
1377452|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - predelivery||||participants|||Number
1377453|NCT01481740|Primary|Incidence of Nausea and Vomiting||24hrs postoperative||||participants|||Number
1377454|NCT01481740|Primary|Incidence of Nausea and Vomiting||2 hrs postoperative||||participants|||Number
1377455|NCT01481740|Primary|Incidence of Nausea and Vomiting||intraoperative 2-3 hours||||participants|||Number
1377456|NCT01481558|Primary|Apathy Symptoms|Apathy evaluated by Apathy Scale by Starsktein et al, 1992, which consists of 14 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale. The total score range from 0 to 42, with higher scores indicating greater apathy severity. Apathy was assessed at baseline and at the end of the sixth session (second week).|Differences in outcome measure comparing second week to baseline|"alpha=5%, power=80%, SD estimated at 8 on Apathy scale scores, and correlation coefficient estimated at 0.7, a sample with 20 participants per arm is required to detect a between-group effect size of 0.5.~Intention to treat (ITT) analyses were conducted using the method of last observation carried forward (LOCF) for missing data."|||units on a scale||95% Confidence Interval|Mean
1377457|NCT01481376|Secondary|Hospital Length of Stay||Duration of the hospital stay (expected average of 1 day)||||Days||Standard Deviation|Mean
1377458|NCT01481376|Secondary|Operative Time||From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)|||||||
1377459|NCT01481376|Secondary|Patient Satisfaction||at least 12 month post-operatively||||participants|||Number
1377460|NCT01481376|Secondary|Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc||up to 12 months||||participants|||Number
1377461|NCT01481376|Secondary|Analgesic Use||The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively|||||||
1377462|NCT01481376|Secondary|Incidence of Groin Pain (Pain Score 0-10)||12 month post-operatively||||participants|||Number
1377463|NCT01481376|Primary|Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery.|Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin. The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the recurrence diagnosis is confirmed during a physical examination by a physician.|At least 12 months post-surgery||||participants|||Number
1377464|NCT01481324|Primary|Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)|Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.|3 months||||percentage of time worn||Full Range|Mean
1377465|NCT01481129|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 30 days||||Participants|||Count of Participants
1377466|NCT01481129|Secondary|Progression-free Survival (PFS)|Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|From the date of inclusion to the date of first documented disease progression, relapse or death from any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
1377467|NCT01481129|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|From the date of inclusion to the date of death from any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
1377468|NCT01481129|Secondary|Duration of Response|Described in responding subjects using descriptive statistics (median, extreme values, etc.).|up to 4 years|No responses were observed||||||
1377469|NCT01481129|Primary|Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007)|Rate of CR + PR according to Cheson 2007 after 4 months of treatment|Up to 4 months||||objective response|||Number
1377470|NCT01481116|Secondary|Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104|The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline.|Baseline and Weeks 26, 52, 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
1377471|NCT01481116|Secondary|Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia||Weeks 26, 52, 78 and 104|Data for this outcome measure was not analyzed as prespecified in the protocol.||||||
1377472|NCT01481116|Secondary|Percentage of Participants With HbA1c <7%||Weeks 26, 52, 78 and 104|FAS included all randomized subjects who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.|||percentage of participants|||Number
1377473|NCT01481116|Secondary|Change From Baseline in HbA1c at Weeks 26 and 52|The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline.|Baseline and Weeks 26 and 52|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1377474|NCT01481116|Secondary|Change From Baseline in Body Weight at Weeks 78 and 104|The change between the body weight to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period. Data for body weight was not available at Week 104 due to early termination of the study.|||kg||Standard Error|Least Squares Mean
1377475|NCT01481116|Secondary|Percentage of Participants With Hypoglycemia|Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded.|Day 1 up to Weeks 78 and 104|Safety analysis set included all participants who received at least 1 dose of double-blind study medication. Participants were analyzed according to the study medication they received.|||percentage of participants|||Number
1377476|NCT01481116|Primary|Change From Baseline in HbA1c at Weeks 78 and 104|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline assessment.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1377477|NCT01480843|Primary|Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months|frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data|baseline, 5 months, 8 months|Subject drop outs|||episodes of hypoglycemia||Standard Deviation|Mean
1377478|NCT01480843|Primary|Change in Duration of Hypoglycemia Episodes|duration of hypoglycemia measured by continuous glucose monitoring|baseline, 5 months, 8 months|Subject drop outs|||minutes of hypoglycemia||Standard Deviation|Mean
1377479|NCT01480674|Secondary|The Duration of Treatment of Trastuzumab|Total treatment duration and duration of the first line of treatment is reported.|Up to 1 Year|Analyzed Set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.|||Years||Standard Deviation|Mean
1377480|NCT01480674|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.|Up to 1 year|The safety population set included of all participants who received at least one dose of study drug. Participants with available data in the prospective period were analysed.|||Participants|||Number
1377481|NCT01480674|Secondary|Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment|Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
1377482|NCT01480674|Secondary|Dosage Schedule of Herceptin Treatment|Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
1377483|NCT01480674|Secondary|Overall Survival|The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.|||Years||95% Confidence Interval|Median
1377484|NCT01480674|Secondary|Time to Progression|The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.|||Years||95% Confidence Interval|Median
1377485|NCT01480674|Secondary|Progression-free Survival|The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.|||Years||95% Confidence Interval|Median
1377486|NCT01480674|Primary|Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment|Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.|||Percentage of participants||95% Confidence Interval|Number
1377625|NCT01479478|Secondary|Neonatal C-reactive Protein Level|Maximum neonatal C-reactive protein level|Up to 14 days following delivery|Participants with available data were included in the analysis.|||mg/L||Inter-Quartile Range|Median
1377487|NCT01480674|Primary|Tumor Hormone Receptor Status of Participants Without Progression|The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.|||Percentage of participants||95% Confidence Interval|Number
1377488|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores range from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
1377489|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores ranges from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 12 and Week 24|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
1377490|NCT01480596|Secondary|Number of Participants With MGFA-PIS (Unchanged, Improved, Worsened) at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being unchanged, improved or worsened.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
1377491|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Response Sustained Response (PR at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
1377492|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Minimal Manifestation Sustained Response (MM at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
1377493|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Remission or Better at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
1377494|NCT01480596|Secondary|Number of Participants With a Myasthenia Foundation of America-post Intervention Status (MGFA-PIS) of Minimal Manifestation or Better at Week 24 and Week 36.|Myasthenia Foundation of America-post intervention status assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
1377503|NCT01480596|Secondary|Number of Participants With a Sustained Response in the QMG Score|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Odds ratios are calculated by Cochran-Mantel-Haenszel method stratified by the observed median baseline score (<= median, > median). Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
1377495|NCT01480596|Secondary|Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
1377496|NCT01480596|Secondary|Median Time to MGC Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants' last available assessment prior to initiation of study intravenous (IV) infusion.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).||||||
1377497|NCT01480596|Secondary|Number of Participants With a Sustained Response in the MGC Score|AA sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Odds ratios are calculated by Cochran-Mantel-Haenszel method without adjusting for any strata. Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
1377498|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
1377499|NCT01480596|Secondary|Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
1377500|NCT01480596|Secondary|Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through to Week 24|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit.|Baseline and up to Week 24|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
1377501|NCT01480596|Secondary|Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. Total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (mild) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at baseline (BL) is the average of the screening and Week 0 BL scores. Change from BL was calculated by subtracting the BL value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative trt difference indicates benefit relative to placebo. Analysis method was Mixed-Model Repeated Measures adjusted for Trt, Visit, BL QMG Score, Trt by Visit and BL QMG Score by Visit. Only follow-up visits are presented but the analysis also includes all trt phase visits. Only those par. available at indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
1377502|NCT01480596|Secondary|Median Time to QMG Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).||||||
1377504|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through to Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (<=median, > median). Exact odds ratio, double the exact one-sided p-value and exact confidence interval were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
1377505|NCT01480596|Secondary|Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (less than or equal to [<=] median, greater than [ >] median). Exact odds ratio, double the exact one-sided p-value and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
1377506|NCT01480596|Primary|Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means were presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline QMG Score, Treatment by Visit, and Baseline QMG Score by Visit.|Baseline and Week 24|Intent-to-Treat (ITT) Population includes participants in the Safety Population who has provided any post treatment efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
1377507|NCT01480297|Primary|Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm|Intra-epidermal Nerve Fiber Density (IENFD) was measured at two anatomic locations (thigh and ankle) at baseline and after 12 weeks of treatment with Salsalate. IENFD is expressed as fibers per mm. Means and standard deviations are shown.|Baseline and 12 weeks|Type 1 diabetes with painful neuropathy|||fibers per mm||Standard Deviation|Mean
1377508|NCT01480284|Secondary|Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study)|"The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered Negative in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study)|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1377509|NCT01480284|Secondary|Number of Participants With Virological Breakthrough Through End of the Study|The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit.|From Baseline to throughout study|FAS Population|||Participants|||Number
1377510|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
1377511|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
1377512|NCT01480284|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBsAg and negative HBsAb at Baseline were analyzed.|||Participants|||Number
1377513|NCT01480284|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population.|||Participants|||Number
1377626|NCT01479478|Secondary|Neonatal Bilirubin Level||Up to 14 days following delivery|Participants with available data were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
1377514|NCT01480284|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg and negative HBeAb at Baseline were analyzed.|||Participants|||Number
1377515|NCT01480284|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg at Baseline were analyzed.|||Participants|||Number
1377516|NCT01480284|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of IP and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.|||Participants|||Number
1377517|NCT01480284|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96|The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
1377518|NCT01480284|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96|The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values.|Baseline, Week 48 and Week 96|Full Analysis Set (FAS) Population: all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation.|||log10 copies/mL||Standard Deviation|Mean
1377519|NCT01480284|Primary|Mean Change From Baseline in Serum HBV DNA Level at Week 24|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 24|Per Protocol Set (PPS) Population: all participants who received at least 1 dose of investigational product (IP) and had at least one efficacy assessment after the treatment initiation, and with no major protocol violations. Missing values observed during the treatment period were imputed by the last observation carried forward (LOCF) method.|||log10 copies/milliliter (copies/mL)||Standard Error|Least Squares Mean
1377520|NCT01480232|Secondary|Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time|This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT)|Baseline, week 1, week 12||||mili seconds||Standard Deviation|Mean
1377521|NCT01480232|Secondary|Safety and Tolerability of EVP-6124 Alone or Combined With NRT|All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12|Weeks 1-12||||Participants|||Count of Participants
1377522|NCT01480232|Secondary|Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time|The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an ‘X’. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure.|Baseline, week 1, week 12||||mili seconds||Standard Deviation|Mean
1377523|NCT01480232|Primary|Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point|CO concentration was measured at every visit.|Baseline, Weeks 1, 2, 4, 6, 8, 10, 12||||part per million||Standard Deviation|Mean
1377524|NCT01480232|Primary|Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence|Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) <10 ppm and/or urine cotinine <50 ng/mL.|Week 1, 2, 4, 6, 8, 10, 12|The primary smoking cessation variable is biochemically verified self-report of 7-day point prevalence abstinence at 12 weeks (end of treatment).|||% participants with 7-Day Point Prevalen|||Number
1377525|NCT01480219|Primary|Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)||Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8|Final analysis set included participants who met the eligibility criteria.|||participants|||Number
1377569|NCT01479868|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.|Week 1 to 72|"The ITT population included all participants who received at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure."|||percentage of participants|||Number
1377526|NCT01480089|Secondary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|12 hours after surgery|All individuals randomized are included in this analysis.|||millimeters||Standard Deviation|Mean
1377527|NCT01480089|Primary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|2 hours after surgery|All individuals randomized are included in this analysis.|||millimeters||Standard Deviation|Mean
1377528|NCT01480076|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|From signing of Informed Consent (SAEs) or from first dose of study treatment (AEs) through Week 50 or Early Termination (14 +/- 7 days after last dose)|Intent-to-treat population: all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit.|||participants|||Number
1377529|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of activity impairment||Standard Error|Least Squares Mean
1377530|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of overall work impairment||Standard Error|Least Squares Mean
1377531|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of impairment while working||Standard Error|Least Squares Mean
1377604|NCT01479595|Secondary|Change From Baseline in Maximum Expiratory Flow|Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||L/sec||Standard Deviation|Mean
1377532|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of work time missed||Standard Error|Least Squares Mean
1377533|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377534|NCT01480076|Secondary|Change From Baseline in the Current Health State of EQ-5D VAS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377535|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the PRIMUS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377536|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377537|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377538|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377539|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377540|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of activity impairment||Standard Error|Least Squares Mean
1377541|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of overall work impairment||Standard Error|Least Squares Mean
1377542|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of impairment while working||Standard Error|Least Squares Mean
1377570|NCT01479868|Secondary|Percentage of Participants With Viral Breakthrough|Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1377543|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of work time missed||Standard Error|Least Squares Mean
1377544|NCT01480076|Secondary|Change From Baseline in EQ-5D Index Scores at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377545|NCT01480076|Secondary|Change From Baseline in Current Health State of the EQ-5D VAS at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377546|NCT01480076|Secondary|Change From Baseline in the Activity Limitation Scale (ALS) of PRIMUS Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377547|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377548|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377549|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377550|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377551|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of activity impairment||Standard Error|Least Squares Mean
1377552|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of overall work impairment||Standard Error|Least Squares Mean
1377553|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of impairment while working||Standard Error|Least Squares Mean
1377571|NCT01479868|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1377619|NCT01479478|Secondary|Length of Neonatal Hospital Stay||Up to 14 days following delivery|Participants with available data were included in the analysis.|||days||Inter-Quartile Range|Median
1377554|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS, by the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of work time missed||Standard Error|Least Squares Mean
1377555|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying United Kingdom (UK) weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377556|NCT01480076|Secondary|Change From Baseline in the Current Health State of EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Months 3, 6, 9, And 12|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377557|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) at Months 3, 6, 9, and 12|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377558|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377559|NCT01480076|Secondary|Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377560|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377561|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12). In contrast to the primary endpoint, this analysis was done using data from both responder and non-responder groups; therefore, 'responder group' and 'visit by responder group interaction' were included as fixed effects.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377562|NCT01480076|Primary|Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. Within-group least squares means are presented.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
1377563|NCT01479868|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.|Week 1 to Week 72|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
1377564|NCT01479868|Secondary|Change From Baseline in CD4+ Cell Count in Percentage||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."|||percentage of lymphocyte||Standard Deviation|Mean
1377565|NCT01479868|Secondary|Mean Change From Baseline in CD4+ Cell Count||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."|||cell counts per microliter||Standard Deviation|Mean
1377566|NCT01479868|Secondary|Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here n signifies participants evaluable for this measure at specified time point."|||copies per milliliter||Standard Deviation|Mean
1377567|NCT01479868|Secondary|Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure|Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.|Baseline to Week 72.|Participants who received potent anti-HIV treatment with a combination of more than 3 anti-antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed.|||percentage of participants|||Number
1377568|NCT01479868|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase Levels|Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.|Baseline up to Week 72|"The ITT population included all participants who received at least 1 dose of study drug. Here N signifies participants evaluable for this measure."|||percentage of participants|||Number
1377603|NCT01479595|Secondary|Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies|Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.|12 weeks|All randomized participants|||Participants|||Number
1377572|NCT01479868|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable|Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.|Week 4, 12, 24, 36, and 48|"ITT population included all participants who had at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure, n is the number of participants analyzed for this outcome measure at specific time points."|||percentage of participants|||Number
1377573|NCT01479868|Secondary|Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)|The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.|24 weeks after end of treatment (Week 24 or 48)|The ITT population included all perticipants who had at least 1 dose of study drug.|||percentage of participants|||Number
1377574|NCT01479868|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)|The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.|12 weeks after end of treatment (Week 24 or 48)|Intent to treat (ITT) population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1377575|NCT01479777|Secondary|Change in Peak Cough Flow|Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||liters/minute||Full Range|Mean
1377576|NCT01479777|Secondary|Change in Vital Capacity|Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||litres||Full Range|Mean
1377577|NCT01479777|Secondary|Change in Rate of Perceived Exertion|"Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters.~The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion."|Baseline, 8 weeks||||scores on RPE scale||Full Range|Mean
1377578|NCT01479777|Secondary|Change in Diastolic Plood Pressure|Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||mmHg||Full Range|Mean
1377579|NCT01479777|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||mmHg||Full Range|Mean
1377580|NCT01479777|Secondary|Change in Heart Rate|Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||beats per minute||Full Range|Mean
1377581|NCT01479777|Primary|Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)|"Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome.~AIS Classificatrion:~A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5.~B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.~C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.~D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.~E = Normal: motor and sensory function are normal."|Baseline, 8 weeks||||scores on AIS Scale||Full Range|Mean
1377582|NCT01479764|Secondary|Time From Start of Study Drug Administration to Operating Room Discharge-ready|The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.|Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).|||minutes||95% Confidence Interval|Least Squares Mean
1377583|NCT01479764|Primary|Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry|Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|At PACU entry on Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate) and had a reliable TOF measurement at PACU entry.|||participants|||Number
1377584|NCT01479725|Primary|Global Response Assessment (GRA)|The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they received hyperbaric oxygen therapy (HBOT). Responses are: 1 Markedly Worse, 2 Moderately Worse, 3 Mildly Worse, 4 Unchanged, 5 Mildly Better, 6 Moderately Better and 7 Markedly Better.|3 months post treatment||||number of participants|||Number
1377585|NCT01479621|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model including all treatment groups: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.|||liters/minute||Standard Error|Least Squares Mean
1377586|NCT01479621|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model including all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.|||liters/minute||Standard Error|Least Squares Mean
1377587|NCT01479621|Other Pre-specified|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.~The p-values for the treatment comparisons to placebo are from an MMRM model including data from all treatments: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.|||liters||Standard Error|Least Squares Mean
1377588|NCT01479621|Secondary|Oropharyngeal Exam Findings at Each Study Visit|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study.~Data format: Time frame, <signs of oral candidiasis?> yes or no"|Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12|Safety population|||Participants|||Count of Participants
1377589|NCT01479621|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 -84|Safety analysis set|||Participants|||Count of Participants
1377590|NCT01479621|Secondary|Time of Maximum Concentration (Tmax) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.|||hours||Standard Deviation|Mean
1377591|NCT01479621|Secondary|Maximum Observed Plasma Concentration (Cmax) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.|||pg/mL||Standard Deviation|Mean
1377592|NCT01479621|Secondary|Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.|||pg*hr/mL||Standard Deviation|Mean
1377593|NCT01479621|Secondary|Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12|The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF.|Day 1 to Day 84|Full analysis set|||probability||95% Confidence Interval|Number
1377620|NCT01479478|Secondary|Count of Neonates With Intensive-care Unit Admission||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377594|NCT01479621|Secondary|Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period|"The number of inhalations of rescue medication used each day and each night was recorded in the subject’s diary device.~Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject.~Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean."|Baseline (Days -7 to -1), During Study (Days 1-84)|Full analysis set|||percentage of total 24 hour periods||Standard Error|Mean
1377595|NCT01479621|Secondary|Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #13).|||liters/minute||Standard Error|Least Squares Mean
1377596|NCT01479621|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #12).|||liters/minute||Standard Error|Least Squares Mean
1377597|NCT01479621|Primary|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #11).|||liters||Standard Error|Least Squares Mean
1377598|NCT01479595|Secondary|Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.|baseline, 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||parts per billion (ppb)||Standard Error|Least Squares Mean
1377599|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ug/mL||Standard Deviation|Mean
1377600|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ng/mL||Standard Deviation|Mean
1377601|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ug/mL||Standard Deviation|Mean
1377602|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ng/mL||Standard Deviation|Mean
1377605|NCT01479595|Secondary|Morning and Evening Peak Expiratory Flow (PEF) Rate|Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.|Baseline and 12 weeks|No analysis was performed on the collected data with the eDiary device due to overall poor data quality (values were obtained that were not physiologically possible) and high variability. Therefore, there is no data to present for this outcome measure.||||||
1377606|NCT01479595|Secondary|Change in Asthma Quality of Life Questionnaire (AQLQ) Score|"The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.~Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes."|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1377607|NCT01479595|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1377608|NCT01479595|Primary|Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1377609|NCT01479543|Secondary|Gastrointestinal and Immune Effects of Probiotics Consumption.|"Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks).~Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period)."|At Time zero, after 4 weeks, and 2 later.|||||||
1377610|NCT01479543|Primary|Gastrointestinal Tolerance After Probiotic Consumption.|"Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the number of participants was tolerant to the intervention."|4 weeks of the treatments. Daily recorded.|Calculation of simple size was based on the variance in the probiotic strain count (log strain CFU/g) in feces and a difference of 25% compared with the placebo. alfa: 0.05 power 90%|||participants|||Number
1377611|NCT01479530|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF|||units on a scale||Standard Error|Mean
1377612|NCT01479530|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF|||units on a scale||Standard Error|Mean
1377613|NCT01479530|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 16|FAS; last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
1377614|NCT01479530|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary|"Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.~The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time."|Baseline and Weeks 4, 8, 12, and 16|Full-analysis set (FAS); observed cases (OC)|||hours||Standard Error|Mean
1377615|NCT01479517|Secondary|Naris Examination|Number of patients with an abnormal naris examination finding.|60 minutes post drug administration||||Participants|||Count of Participants
1377616|NCT01479517|Secondary|The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.||60 minutes||||participants|||Number
1377617|NCT01479517|Secondary|The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.||60 minutes||||participants|||Number
1377618|NCT01479517|Primary|The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure||at 15 minutes, with +10 minute window||||participants|||Number
1377627|NCT01479478|Secondary|Apgar Score at 1 and 5 Minutes Following Delivery|Apgar score is a measure to quickly assess the neonatal health status from time of delivery. Score ranges from 0-10. Lower scores correspond to worse health state; neonates with scores below 5 are considered to have poor prognosis.|At time of delivery (up to 42 weeks of gestation)|Participants with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1377628|NCT01479478|Secondary|Gestational Age at Delivery|Gestational age at delivery is presented as weeks.|At time of delivery (up to 42 weeks of gestation)|Participants with available data were included in the analysis.|||weeks||Inter-Quartile Range|Median
1377629|NCT01479478|Secondary|Count of Participants With Other Infectious Morbidity|Other infectious morbidity included maternal mastitis or pneumonia.|From time of labor onset up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377630|NCT01479478|Secondary|Count of Participants With Sepsis|Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection.|From labor onset up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377631|NCT01479478|Secondary|Count of Participants With Bacteremia|Bacteremia is defined as presence of bacteria in the blood.|From time of labor onset up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377632|NCT01479478|Secondary|Count of Participants With Cellulitis|Cellulitis is a bacterial skin infection.|From time of delivery up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377633|NCT01479478|Secondary|Count of Participants With Endometritis|Endometritis is a uterine (myometrial) infection.|From time of delivery up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377634|NCT01479478|Secondary|Count of Participants With Intrapartum Chorioamnionitis|Intrapartum chorioamnionitis is maternal temperature above 38.0 degrees Celsius and one or more of the following findings: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent or malodorous amniotic fluid, or elevated maternal white blood cell count.|From time of labor onset until delivery (up to 42 weeks of gestation)|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377635|NCT01479478|Secondary|Count of Participants With Urinary Tract Infection||From enrollment up to delivery hospitalization (up to 42 weeks gestation)|Participants with available data were included in the analysis.|||Participants|||Count of Participants
1377636|NCT01479478|Primary|Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age|Gestational age is given in a format of full weeks.|35 to 37 weeks gestational age|Participants with available data were included in the analysis|||Participants|||Count of Participants
1377637|NCT01479374|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
1377638|NCT01479374|Secondary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
1377639|NCT01479374|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
1377640|NCT01479374|Secondary|Mean Conjunctival Redness at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
1377641|NCT01479374|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
1377642|NCT01479374|Primary|Mean Ocular Itching at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
1377643|NCT01479374|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
1377644|NCT01479127|Secondary|Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377645|NCT01479127|Secondary|Ratio of Metabolite 3-OMD to Levodopa (M/P [AUC0-12]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|M/P (AUC0-12) after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||ratio||Standard Deviation|Mean
1377646|NCT01479127|Secondary|Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Degree of Fluctuation (calculated as [Cmax – Cmin] / Cavg)) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||ratio||Standard Deviation|Mean
1377647|NCT01479127|Secondary|AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12/Dose0-12 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). AUC0-16/Dose0-16 of levodopa, carbidopa, and 3-OMD after administration of intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||µg*h/mL/mg||Standard Deviation|Mean
1377648|NCT01479127|Secondary|The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12 and AUC0-16 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||µg*h/mL||Standard Deviation|Mean
1377649|NCT01479127|Secondary|Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Cmax, Cavg, Cmin, and Cmin (2-12 hours) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). Cmin values for levodopa and carbidopa during the 16 hours of infusion were observed either at time 0 or 15 min after start of the infusion and were a result of drug washout prior to establishment of infusion.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||µg/mL||Standard Deviation|Mean
1377650|NCT01479127|Secondary|Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187|Tmax of levodopa, carbidopa, and its metabolite 3-O-methyldopa (3-OMD) after administration of oral L/C tablets and intra-jejunal administration of ABT-SLV187.|Baseline (Day -1): pre-dose; 15, 30, 45, 60 mins post-morning dose; every 30 mins thereafter for 12 hrs. Day 21: pre-dose; 15, 30, 45, 60 mins post-infusion; every 30 mins from hrs 1 to 12 post-infusion; every 2 hrs from 12 to 16 hrs post-infusion.|Pharmacokinetic (PK) sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||hours||Standard Deviation|Mean
1377651|NCT01479127|Primary|Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the “Normal” State on the Treatment Response Scale (TRS) I|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists’ evaluations was calculated as a percentage of ratings in the “Normal” state (ie, “mild OFF” to “ON with mild dyskinesia”) on the TRS I (total 10 assessments per day).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||percentage of ratings||Standard Deviation|Mean
1377652|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period|High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377653|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period|↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377654|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377676|NCT01478971|Secondary|Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion||12 months|Safety population|||percentage of participants|||Number
1377677|NCT01478971|Secondary|Percentage of Participants Who Received at Least One Intravenous Iron Dose|Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.|12 months|Safety population|||percentage of participants|||Number
1377655|NCT01479127|Secondary|Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||participants|||Number
1377656|NCT01479127|Secondary|Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment|The Schwab and England scale was used to rate the subject’s activities of daily living by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Full Range|Median
1377657|NCT01479127|Secondary|Modified Hoehn and Yahr Staging at Baseline and End of Treatment|Participant’s ON and OFF states staged according to the Modified Hoehn and Yahr criteria, an 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Full Range|Median
1377658|NCT01479127|Secondary|Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients, including Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort, as well as a Summary Index Total Score. Scores for each are on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1377659|NCT01479127|Secondary|Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score ranges from 0-176, with 176 representing the worst (total) disability, and 0 no disability. The Part I Score is the sum of the answers to the 4 questions related to Mentation, Behavior and Mood, and ranges from 0-16. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. The Part IV Score is the sum of the answers to the 11 questions related to Complications of Therapy, and ranges from 0-23. The Part IV dyskinesia subscore ranges from 0-12. For each part of the UPDRS, higher scores are associated with more disability.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1377660|NCT01479127|Secondary|Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the video under blinded conditions using the following assessments: Tremor at Rest (UPDRS item #20), Finger Taps (UPDRS #23), Rapid Alternating Movement of Hands (UPDRS #25), Arising from Chair (UPDRS #27), Gait (UPDRS #29), Postural Stability (UPDRS #30), Body Bradykinesia and Hypokinesia (UPDRS #31), and Dyskinesia (evaluated with the Goetz Dyskinesia Rating Scale). The UPDRS score is the sum of the answers to individual questions, each of which are measured on a 5-point scale (0-4), with higher scores associated with more disability. The Goetz Dyskinesia Rating Scale is a 5-point scale of the severity of dyskinesias, from 0 (absent) to 4 (violent dyskinesias).|Baseline (Day -1), Endpoint (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1377661|NCT01479127|Secondary|Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment|For each half hour period during 3 consecutive days prior to each assessment of the diary, participants (and/or their caregivers) entered into a diary whether they were asleep, in the ON motor state or in the OFF motor state in the following 5 grades: asleep, OFF, ON (no dyskinesia [D]), ON with non-troublesome dyskinesia (NTD), ON with troublesome dyskinesia (TD). ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug. Dyskinetic time is time with involuntary muscle movement. The ON or OFF times were calculated as the average of 3 daily times from the diaries. w/o = without, w/ = with|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||hours||Standard Deviation|Mean
1377678|NCT01478971|Secondary|Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL|Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.|Months 1, 2, 3, 4, 5 and 6 of each treatment period|Full Analysis Population included all enrolled participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period. n indicates the number of participants with available data at each time point.|||percentage of participants|||Number
1377679|NCT01478971|Secondary|Peginesatide Dose Deviations|Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.|Months 6 - 12|||||||
1377680|NCT01478971|Secondary|Peginesatide Dosing|The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.|Month 6 - 12|Participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period.|||mg||Standard Deviation|Mean
1377662|NCT01479127|Secondary|Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the “OFF” and “Dyskinesia” States on the TRS I and the “Normal,” “OFF,” and “Dyskinesia” States on the TRS II|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and TRS under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia for TRS I, with the addition of Tremor at Rest and Postural Stability for TRS II. The average of the 3 neurologists’ evaluations was calculated as a percentage of ratings in the “Normal” state (ie, “mild OFF” to “ON with mild dyskinesia”), the “Off” state (“moderate OFF” to “severe OFF”), and the “Dyskinesia” state (“ON with moderate dyskinesia” to “ON with severe dyskinesia”) on the TRS I or II.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||percentage of ratings||Standard Deviation|Mean
1377663|NCT01479127|Primary|Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period|M=male, F=female|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377664|NCT01479127|Primary|Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period|M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377665|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period|M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377666|NCT01479127|Primary|Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
1377667|NCT01479127|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|During the Run-in period (up to approximately 28 days)|Full safety sample: participants who had at least one dose of oral levodopa-carbidopa study drug in the Run-in Period.|||participants|||Number
1377668|NCT01479010|Secondary|Oxygen Uptake Efficiency Slope||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377669|NCT01479010|Secondary|Total Exercise Time||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377670|NCT01479010|Secondary|Rate of Adverse Events and Hospitalizations||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377671|NCT01479010|Secondary|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377672|NCT01479010|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377673|NCT01479010|Secondary|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377674|NCT01479010|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377675|NCT01479010|Primary|Median Interval Change From Baseline in Peak VO2|Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
1377682|NCT01478958|Secondary|Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)|Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).|4 months|||||||
1377683|NCT01478958|Secondary|Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)|PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)|4 months|||||||
1377684|NCT01478958|Secondary|24-hour Ambulatory Blood Pressure|24-hour, daytime and night-time measures of systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP; SBP-DBP) and heart rate (HR)|4 months|||||||
1377685|NCT01478958|Secondary|Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)|Data for fasting serum lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC:HDL-C ratio, low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG)).|4 months|||||||
1377686|NCT01478958|Primary|Percent Change in Flow Mediated Dilatation (FMD)||Baseline, 4 months|Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully.|||post-occlusion diameter change as %||Standard Error|Mean
1377687|NCT01478828|Secondary|Capture Difference in MYC Downregulation Between Treated Participants and Non-treated Patients|7. To compare the MYC downregulation between our prostatectomy samples treated with high-dose lovastatin and up to 21 matched prostatectomy reference samples from untreated patients from a pre-existing reference dataset.|1 year|||||||
1377688|NCT01478828|Secondary|Number of Participants Who Follow All of the Study Rules.|6. To assess the study compliance.|1 year|||||||
1377689|NCT01478828|Secondary|Capture the Associated Changes in Participants With Regards to the Relationship Between MYC and Increased Apoptosis.|5. To assess an association of pharmacodynamic target inhibition of MYC with markers of increased apoptosis (cleaved caspase-3) and proliferation (Ki-67).|1 year|||||||
1377690|NCT01478828|Secondary|Capture the Pharmacodynamic Changes in Participants After the Pre-treatment Biopsy.|4. To assess the relationship of pharmacodynamic target inhibition of MYC with pretreatment prostate biopsy Gleason sum, Ki-67, and degree of MYC overexpression.|1 year|||||||
1377691|NCT01478828|Secondary|Number and Type of Cholesterol Changes After Lovastatin Treatments.|3. To characterize the effect of continuous daily oral lovastatin on cholesterol level in this patient population, at the doses tested in this trial.|1 year|||||||
1377692|NCT01478828|Secondary|To Estimate What the Doses Given to Men With MYC Target Inhibition When Factoring in Their Tumor Biopsies Before and After Lovastatin Treatment.|2. To estimate an overall and per dose proportion of men with MYC target inhibition in prostate tumor tissue using paired tumor biopsies before and after lovastatin administration.|1 year|||||||
1377693|NCT01478828|Secondary|Number of Participants Who Experience Specific Adverse Events at Different Dosing Points Prior to Surgery.|1. To assess the tolerability and toxicity of the different doses of continuous daily oral lovastatin in generally healthy men with prostate cancer prior to surgery.|1 year|||||||
1377694|NCT01478828|Primary|Number of Participants That Can Achieve 60% MYC Modulation Response|To determine the dose of continuous daily oral lovastatin needed to achieve MYC down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.|1 year||||participants|||Number
1377695|NCT01478620|Secondary|Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)|||||||
1377696|NCT01478620|Secondary|Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)|||||||
1377697|NCT01478620|Secondary|Proportion of Patients Who Require Antibiotic Treatment Until Day 7||During active treatment period|||||||
1377698|NCT01478620|Secondary|Duration of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)|||||||
1377699|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 37||Day 37|||||||
1377700|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 7||Day 7|||||||
1377701|NCT01478620|Secondary|Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)||Day 7|||||||
1377702|NCT01478620|Secondary|Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days||During active treatment period|||||||
1377703|NCT01478620|Primary|Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N|No study drug related adverse drug reactions were registered.|During active treatment period (day 1 until day 7)||||Adverse Drug Reactions|||Number
1377704|NCT01478594|Secondary|Progression-Free Survival Events by Tumor Placental Growth Factor (PIGF) RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor PIGF RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
1377705|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-D RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-D RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
1392952|NCT01329978|Secondary|Change in HCV RNA at Week 4||Baseline (Day 1) to Week 4|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1377706|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C / VEGF-A RNA Ratio|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C/VEGF-A RNA ratio.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
1377707|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
1377708|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-A Ribonucleic Acid (RNA) Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-A RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
1377709|NCT01478594|Secondary|Progression-Free Survival Events by Serum Neuropilin Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum neuropilin level. Neuropilin protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
1377710|NCT01478594|Secondary|Progression-Free Survival Events by Serum Interleukin-8 (IL-8) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum interleukin-8 level. IL-8 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
1377711|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-3 (sVEGFR-3) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-3 level. sVEGFR-3 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
1377712|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-2 (sVEGFR-2) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-2 level. sVEGFR-2 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
1377713|NCT01478594|Secondary|Progression-free Survival Events by Serum VEGF-C / VEGF-A Ratio|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C/VEGF-A ratio. VEGF-A and VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the ratio is expressed relative to the observed median.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
1377714|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-C (VEGF-C) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C level. VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
1377715|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-A (VEGF-A) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum vascular endothelial growth factor-A (VEGF-A) level. VEGF-A protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
1377716|NCT01478594|Secondary|Progression-free Survival Events by Lactate Dehydrogenase (LDH) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum lactate dehydrogenase status.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||participants|||Number
1377717|NCT01478594|Secondary|Safety as Assessed by Physical Examination, Vital Signs, Laboratory Assessments, 12-lead Electrocardiogram (ECGs), and Adverse Events (AEs)|"An abnormality identified during a medical test is defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion.~An AE was serious if it resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required or prolonged inpatient hospitalization or other medically important event.~AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute Common Terminology Criteria for Grading Adverse Events (NCI-CTCAE) Version 4.03 per the following: 1=mild; 2= moderate; 3= severe; 4= life threatening; 5=death.~Treatment-related AEs were defined as events where the relationship to study drug was marked as probably or possibly, or was missing."|From first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib (tiv) arm and 162.0 days in the bevacizumab (bev) arm.|The safety analysis set consisted of all randomized participants who received at least one dose of study drug (tivozanib or bevacizumab), analyzed according to the treatment actually received.|||participants|||Number
1377718|NCT01478594|Secondary|Health Related Quality of Life (HRQoL)|Time to deterioration in HRQoL measured by Colorectal cancer (CRC) subscale of the Functional Assessment of cancer Therapy Colorectal (FACT-C) scale, change in score from baseline using the European Quality of Life – 5 Dimensions (EQ-5D) and Fact Colorectal Symptom Index (FCSI) were not evaluated due to study closure.|3 years|Analysis was not performed due to study closure.||||||
1377719|NCT01478594|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) is defined as the time from randomization to last dose date of tivozanib/bevacizumab. If a participant discontinued treatment for any reason, the participant was considered as an event. Participants remaining on treatment at the time of analysis were censored at date of last dose.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||months||95% Confidence Interval|Median
1377720|NCT01478594|Secondary|Duration of Response (DoR)|Duration of response (DoR) is defined as the time from the date of the first documented response of CR or PR (whichever is first recorded) to documented progression or death. If a participant did not progress or had not died at the time of analysis, the duration of response was censored at the date of last tumor assessment. Duration of response is only defined for participants whose best overall response was CR or PR.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Participants with a best overall response of complete response (CR) or partial response (PR).|||months||95% Confidence Interval|Median
1377721|NCT01478594|Secondary|Objective Response Rate (ORR)|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) confirmed a minimum of four weeks apart based on RECIST 1.1 criteria.~CR: Disappearance of all target and non-target lesions and no new lesions.~PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and no progression of non-target lesions and no new lesions, or, disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||percentage of participants|||Number
1377722|NCT01478594|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of randomization until the documented date of death. Participants still alive at the time of analysis were censored on the last day the participant was known to be alive.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||months||95% Confidence Interval|Median
1377723|NCT01478594|Secondary|Progression-Free Survival (PFS) Based on Independent Radiological Review (IRR)|The time from the date of randomization until the date of radiological disease progression assessed by the IRR or until death due to any cause, even in the absence of radiological progression.|3 years|Analysis was not performed due to study closure.||||||
1377724|NCT01478594|Primary|Investigator-assessed Progression-Free Survival (PFS)|"The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1):~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.~Participants who did not progress or had not died at the time of the analysis were censored at the date of last tumor assessment where non-progression was documented."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|The full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
1377725|NCT01478581|Secondary|Duration of Clinical Benefit Response (DCB)|DCB is defined as the time from first observation of response to the time of disease progression.|From the date of first study treatment until disease progression per IMWG, up to 60 months|Clinical benefit responders.|||Months||Full Range|Median
1377956|NCT01475513|Secondary|Change From Baseline in Acute Insulin Response to Glucose|Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response|Baseline, 6 months||||mIU* L^-1 * min||95% Confidence Interval|Mean
1377726|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for AUC0-24h (M/P AUC0-24h)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 AUC0-24h/PCI-45227 molecular weight)/(ibrutinib AUC0-24h/ibrutinib molecular weight) on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||Ratio||Standard Deviation|Mean
1377727|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 Cmax/PCI-45227 molecular weight)/(ibrutinib Cmax/ibrutinib molecular weight) on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||Ratio||Standard Deviation|Mean
1377728|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Accumulation Ratio for AUC0-24h (Acc. Ratio AUC0-24h)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Acc. Ratio calculated as Day 8 ibrutinib AUC0-24h/ Day 1 ibrutinib AUC0-24h.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||Ratio||Standard Deviation|Mean
1377729|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Terminal Elimination Half-life (t1/2,Term).|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||hours||Standard Deviation|Mean
1377730|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h).|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||h∙ng/mL||Standard Deviation|Mean
1377731|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Time to Maximum Observed Plasma Concentration (Tmax).|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||hours||Standard Deviation|Mean
1377732|NCT01478581|Secondary|Pharmacokinetics (PK). (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Maximum Observed Plasma Concentration (Cmax)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
1377733|NCT01478581|Secondary|To Evaluate the Efficacy of PCI-32765 by Assessing ORR|The objective response rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the modified International Myeloma Working Group (IMWG) response criteria.|From the date of first study treatment until disease progression per IMWG, up to 60 months|All treated population|||Participants|||Count of Participants
1377734|NCT01478581|Primary|The Clinical Benefit Response (CBR)|The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria|From the date of first study treatment until disease progression per IMWG, up to 60 months|All treated population|||Participants|||Count of Participants
1377735|NCT01478373|Secondary|DCR (CR+PR+SD) at the End of Treatment|DCR is defined as the proportion of patients with a best overall response of CR, PR and SD at the end of dovitinib treatment according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Up to 9 months of estimated treatment|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
1377785|NCT01477749|Primary|Cumulative CD54 Upregulation|The increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on post-culture versus pre-culture cells. Cumulative CD54 upregulation = CD54 upregulation ratio for infusion 1 + CD54 upregulation ratio for infusion 2 + CD54 upregulation ratio for infusion 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||Ratio||Standard Error|Mean
1377736|NCT01478373|Secondary|Overall Survival (OS) of Patients Treated With Dovitinib|Outcome Measure Description: OS: time from the date of entry into the study to the date of death due to any cause. A patient who has not died by the date of the analysis cut-off would have the OS censored at the time of the last contact before the cut-off date.|21 months (9 months of estimated treatment plus 12 months of survival follow up)|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1377737|NCT01478373|Secondary|Overall Response Rate (ORR) of Patients Treated With Dovitinib|Outcome Measure Description: ORR: proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Baseline, 12 weeks|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
1377738|NCT01478373|Secondary|Time to Tumor Progression (TTP)of Patients Treated With Dovitinib|TTP: time from the date of entry into the study to first documentation of tumor progression or death due to the underlying cancer. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1377739|NCT01478373|Secondary|Duration of Response or Stable Disease (SD)|Duration of response or SD: time from date of entry into study to earliest date of first objective tumor progression or death. DCR is defined as proportion of patients with best overall response of CR, PR and SD at 12 weeks according to RECIST (version 1.1). CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1; PR: At least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||Standard Deviation|Mean
1377740|NCT01478373|Secondary|Time to Treatment Failure (TTF)of Patients Treated With Dovitinib|TTF: the date of entry into the study to the earliest date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1377741|NCT01478373|Secondary|Progression-free Survival (PFS) of Patients Treated With Dovitinib|The PFS duration: time from entry into the study to the date of the first documented progression (assessed using conventional RECIST (version 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||90% Confidence Interval|Median
1377742|NCT01478373|Primary|Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease|DCR is defined as the proportion of patients with a best overall response of Complete Responses (CR), Partial Response (PR) and Stable Disease (SD) at 12 weeks according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|12 Weeks|Full Analysis Set: all subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
1377743|NCT01478360|Primary|Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score|The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.|Baseline and 85 Days|The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received.|||Score||90% Confidence Interval|Least Squares Mean
1377744|NCT01478347|Primary|Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).|The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include – AEs considered to be related to blood draw procedure and all SAEs.|Day 92 to day 331|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part two of the study.|||subjects|||Number
1377745|NCT01478347|Primary|Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.|The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.|Day 1 to day 91|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part one of the study.|||subjects|||Number
1377746|NCT01478256|Secondary|Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics|Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis|Three weeks||||participants|||Number
1377747|NCT01478256|Primary|Improvement in Signs and Symptoms of Blepharitis|Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics|Four weeks||||participants|||Number
1377748|NCT01478113|Secondary|Change in Functioning on Short Form-12(SF-12)|Functional improvement: Comparison between the 2 groups of changes on the SF-12 scale at Baseline and Visit 11/Early termination visit.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
1377749|NCT01478113|Secondary|Change in Positive and Negative Affective Scale (PANAS)|Improvement of deficits in positive affectivity: Comparison between the 2 groups of changes on the PANAS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
1377750|NCT01478113|Secondary|Change in Behavioral Inhibition/Activation Scale (BIS/BAS)|Improvement of deficits in behavioral activation: Comparison between the 2 groups of changes on the BIS/BAS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
1377751|NCT01478113|Secondary|Change in the Snaith-Hamilton Pleasure Scale (SHAPS)|Improvement of anhedonia: Comparison between the 2 groups of changes on the SHAPS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
1377752|NCT01478113|Secondary|Change in Psychological Well-being Scale (PWB)|Well-being improvement: Comparison between the 2 groups of changes on the PWB at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
1377753|NCT01478113|Primary|Change in Hamilton-Depression Rating Scale(SIGH-D)-31 Item|Comparison between the 2 groups of the percentage of participants who have responded to the treatment (response is defined here as a 50% or greater improvement on the HAM-D-31 score) between Baseline and Visit 11 or Early Termination Visit.|Baseline to Visit 11 (which is week 8 of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
1377754|NCT01478113|Primary|Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items|Comparison between the 2 groups of the percentage of subjects in remission, as defined by a HAM-D-17 score of < 8 at endpoint visit 11/week 8 of treatment, or early termination visit.|Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit.|not able to analyze due to small sample size||||||
1377755|NCT01478087|Primary|Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 days post-treatment||||percentage of device related SAE|||Number
1377756|NCT01478087|Primary|Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 Days Post Treatment||||percentage of procedure related SAE|||Number
1377757|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele|ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele at randomization were analyzed.|||percentage of participants||95% Confidence Interval|Number
1377758|NCT01478048|Primary|1 Year Progression-Free Survival Rate - Randomized Participants|PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Year 1 after last participant was randomized|All randomized participants were analyzed.|||percentage probability||95% Confidence Interval|Number
1377768|NCT01477853|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 54 weeks|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.|||Participants|||Number
1377759|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants|ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
1377760|NCT01478048|Secondary|Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele were analyzed.|||Months||95% Confidence Interval|Median
1377761|NCT01478048|Primary|Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants|PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.|Randomization until 111 events, up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.|||Events (progression or death)|||Number
1377762|NCT01478048|Primary|Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.|||Months||95% Confidence Interval|Median
1377763|NCT01478009|Secondary|Total Number of Days of Symptoms and Duration of All Colds|Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds|up to 12 weeks|||||||
1377764|NCT01478009|Secondary|Symptom Severity of All Colds|"Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone.~Symptom severity of all colds (score 0–27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia).~Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst)."|12 weeks|per protocol analysis|||Scores on a scale||Standard Deviation|Mean
1377765|NCT01478009|Primary|Frequency of ILI(Influenza Like Illness)|Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.|12 weeks|per protocol analysis|||participants|||Number
1377766|NCT01477892|Secondary|Adverse Reaction|bradycardia, hypotension, apnea, desaturation|during and after 10min of remifentanil continous infusion||||participants|||Number
1377767|NCT01477892|Primary|Premature Infant Pain Profile|"P0-P2 units on a scale~; changes in PIPP from baseline (P0) to procedure (needle puncture, P2)~PIPP (preterm infant pain profile)~min 0 ~ max 21~higher pain scale on higher score"|first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop||||units on a scale||Standard Deviation|Mean
1377784|NCT01477749|Primary|Cumulative Total Nucleated Cell (TNC) Count|Descriptive summarization of the cumulative sum of TNC counts across infusions|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||10^9 cells/mL||Standard Error|Mean
1377946|NCT01475513|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months|Higher value indicates higher cardiovascular risk|Baseline, 6 months||||mmHg||95% Confidence Interval|Mean
1377769|NCT01477853|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 56 weeks (including 2-week follow-up)|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.|||Participants|||Number
1377770|NCT01477853|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
1377771|NCT01477853|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
1377772|NCT01477853|Secondary|Percent Change From Baseline in Triglycerides at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
1377773|NCT01477853|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
1377774|NCT01477853|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
1377775|NCT01477853|Secondary|Percent Change From Baseline in Total Cholesterol at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
1377776|NCT01477853|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||mg/dL||Standard Error|Mean
1377777|NCT01477853|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Deviation|Mean
1377778|NCT01477853|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.|Baseline and Week 16|Full analysis set (FAS) population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent||Standard Error|Mean
1377779|NCT01477762|Primary|Mean Fear-potentiated Startle to Danger Signal During Late Extinction|This measures the level of fear-potentiated startle (the difference between startle magnitude to the danger signal and baseline startle magnitude) at the end of extinction. Because the danger signal is no longer paired with the aversive stimulus like it was during the conditioning phase, the fear response should decrease from early to late extinction in individuals who show intact extinction learning.|10 hours after drug administration||||microvolts||Standard Error|Mean
1377780|NCT01477762|Primary|Mean Fear-potentiated Startle to Danger Signal During Early Extinction|Fear-potentiated startle was measured as a difference score between the startle to danger signal and the baseline. This difference score reflects the degree of fear response at the beginning of extinction.|10 hours after drug administration||||microvolts||Standard Deviation|Mean
1377781|NCT01477762|Primary|Mean Startle Magnitude to Danger Signal During Fear Conditioning|The acoustic startle response magnitude was measured using electromyography recordings of the eyeblink muscle when a sudden tone was delivered through headphones in the presence of a stimulus that was paired with an aversive outcome (i.e. the danger signal). If an individual showed successful fear learning, then startle to the danger signal would be greater than baseline startle.|10 hours after drug administration||||microvolts||Standard Error|Mean
1377782|NCT01477762|Primary|Mean Baseline Startle Magnitude During Fear Conditioning|The study measured the acoustic startle response magnitude to a sudden noise using electromyography of the eyeblink muscle. This response magnitude was used as the individual's baseline to compare to the startle magnitude to the danger signal to see if fear conditioning had occurred.|10 hours after drug administration||||microvolts||Standard Error|Mean
1377783|NCT01477749|Primary|Product Viability (Percentage)|Product viability was measured as the percentage of live PBMC in final product for infusion 1, 2, and 3 as measured by a trypan blue assay and are reported for each final product for infusion 1, 2, and 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||Percentage of PBMC that are live||Full Range|Mean
1377786|NCT01477749|Primary|Cumulative CD54+ Cell Count|"Descriptive summarization of the cumulative sum of CD54+ counts across infusions.~Cumulative CD54 upregulation = CD54 upregulation for infusion 1 + CD54 upregulation for infusion 2 + CD54 upregulation for infusion 3"|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||10^9 cells/mL||Standard Error|Mean
1377787|NCT01477710|Primary|Tidal Volume|Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded.|10 minutes per technique, for a total of 30 minutes per participant||||milliliters (mL)||Standard Error|Mean
1377788|NCT01477567|Secondary|Number of Participants Forming Antibody to LY3009385|The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.|Baseline through Day 28|Participants who received a dose of LY3009385 or Placebo.|||participants|||Number
1377789|NCT01477567|Secondary|Change in Level of Glucagon Before and After a Standard Meal|The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.|Baseline, Day 14|Participants who received a dose of LY3009385 or Placebo and have evaluable glucagon concentration data. The effect of LY3009385 on postprandial glucagon concentrations was not evaluated on Day 14 for the 0.3 and 1 mg treatment arms.|||picomoles per liter||Standard Deviation|Mean
1377790|NCT01477567|Secondary|Change in Level of C-peptide Before and After a Standard Meal|The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable c-peptide concentration data.|||picomoles times hours per liter||Standard Deviation|Mean
1377791|NCT01477567|Secondary|Change in Level of Blood Glucose Before and After a Standard Meal|The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable blood glucose concentration data.|||milligrams times hours per deciliter||Standard Deviation|Mean
1377792|NCT01477567|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had evaluable LY3009385 concentration data.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1377793|NCT01477567|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385|LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had sufficient quantifiable plasma LY3009385 concentrations in the terminal phase.|||micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
1377794|NCT01477567|Primary|Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs|The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 28|All enrolled participants.|||participants|||Number
1377795|NCT01477463|Secondary|Incidence of Hypercalcemia for Vitamin D Toxicity|Calcium levels|2 years||||participants|||Number
1377796|NCT01477463|Secondary|Vitamin D Toxicity|serum 25(OH)D for|2 years||||ng/ml||Standard Deviation|Mean
1377797|NCT01477463|Primary|Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment|We utilized a prior gene expression study that compared malignant melanoma cells to benign nevi (moles) and identified over 2300 genes that were differentially regulated in melanoma compared to benign nevi. There were approximately 270 genes in our data set that showed changes in expression after vitamin D treatment. We wish to identify overlap between these two groups.|2 years||||number of genes|||Number
1377798|NCT01477463|Primary|Number of Genes That Showed Changes in Expression After Vitamin D Treatment|Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation.|2 years|All subjects treated with vitamin D3.|||number of genes|||Number
1377799|NCT01477450|Primary|Return of Oxygen Saturation to Baseline (Sea Level) Values|Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.|50 minutes||||participants|||Number
1377800|NCT01477333|Primary|Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||dyn*s/cm^5*m^2||Full Range|Median
1377801|NCT01477333|Primary|Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included cardiac index (CI)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||L/min/m^2||Full Range|Median
1377802|NCT01477333|Primary|Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24.|Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||L/min||Full Range|Median
1377803|NCT01477333|Primary|Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||percentage bound to hemoglobin||Full Range|Median
1377804|NCT01477333|Primary|Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24.|Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||beats/min||Full Range|Median
1377805|NCT01477333|Secondary|N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period.|NT-proBNP was assessed at Baseline prior to starting UT-15C SR, Weeks 12 and 24, or at the time of premature termination if prior to Week 24. Blood for NT-proBNP assessment was collected before the 6MWT was conducted.|Weeks 12 and 24|Intent-to-treat population with data available at Baseline and Week 24.|||pg/mL||Standard Deviation|Mean
1377806|NCT01477333|Secondary|Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.|The WHO functional classification for pulmonary hypertension was assessed at Baseline prior to starting UT-15C SR, Weeks 4, 8, 12, and 24, or at the time of premature termination if prior to Week 24. The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment).|Baseline and Weeks 4, 8, 12, and 24|Intent-to-treat population with data available at Baseline and Week 24.|||participants|||Number
1377807|NCT01477333|Secondary|Time to Clinical Worsening Over the Treatment Period.|Clinical worsening was assessed continuously from Baseline through each subject’s last study visit. Clinical worsening was defined as the occurrence of any one or more of the following: death (all causes), hospitalization as a result of worsening pulmonary arterial hypertension (PAH), and initiation of a parenteral prostacyclin.|Clinical worsening was assessed continuously from Baseline through each subject’s last study visit|Intent-to-treat population with data available at Baseline and Week 24.|||Days||Standard Deviation|Mean
1377808|NCT01477333|Secondary|Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.|The 6MWT was conducted at Baseline, 2 to 4 hours after the last Tyvaso dose, and prior to first dose of UT-15C SR. The 6MWT was also performed at Weeks 4, 12, and 24, or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Weeks 4, 12, and 24|Intent-to-treat population with data available at Baseline and Week 24.|||Meters||Full Range|Median
1377809|NCT01477333|Primary|Change in Hemodynamic Parameters From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||mmHg||Full Range|Median
1377810|NCT01477320|Secondary|Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.||Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.||||Participants|||Count of Participants
1377811|NCT01477320|Primary|Number of Subjects With GI Bleeding|"Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients.~Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period."|Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.||||participants|||Number
1377812|NCT01476748|Primary|Trocar Slippages With LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes|Pilot study|||Participants|||Number
1377813|NCT01476748|Secondary|Trocar Slippages Without LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes||||Participants|||Number
1377814|NCT01476722|Primary|Corneal Fluorescein Staining Area at Day 30|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
1377815|NCT01476722|Primary|Corneal Fluorescein Staining Area at Baseline|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
1377816|NCT01476722|Primary|Corneal Fluorescein Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
1377817|NCT01476722|Primary|Corneal Fluorescein Staining Type at Baseline|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
1377818|NCT01476696|Secondary|Number of Participants With Hemorrhagic Events Requiring Medical Intervention|Hemorrhagic events were determined by the study investigator. Medical intervention was defined as any medical attention resulting in therapy or further investigation, as determined by a trained medical professional.|Part B: Baseline up to Day 36|Participants who received at least 1 dose of prasugrel.|||participants|||Number
1377819|NCT01476696|Secondary|Number of Participants With Pain|"The number of participants who answered yes to the first question in the Sickle Cell Disease Pain (SCD) Questionnaire is reported. Question 1: In the past 2 weeks, did you experience any sickle cell pain?"|Part B: Baseline and Day14 ± 4 days postdose in each dosing period|Participants who responded to Question 1 of the SCD Questionnaire. A participant could be counted more than once because there were 2 dosing periods during Part B of the study.|||participants|||Number
1377820|NCT01476696|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite|AUC of prasugrel inactive metabolite(s) from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)]. Improvements in bioanalytical methodology enabled direct measurement of Pras-AM from plasma, obviating the need to estimate its concentration from inactive downstream metabolite(s). Thus, the AUC of prasugrel inactive metabolite(s) was not analyzed.|Part A: 0.5, 1, 1.5, 2, 4 hours postdose|No participants were analyzed.||||||
1377821|NCT01476696|Primary|Percentage of Platelet Inhibition as Measured by VerifyNow™P2Y12 (VN)|Accumetrics VN assay: A point-of-care device that measures platelet aggregation. Percentage of platelet inhibition is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and also during the once-daily repeated dosing phase in Part B, at steady state, 14 ± 4 days after each new dose (0.06, 0.08, and 0.12 mg/kg) is administered. One participant received the same dose at multiple visits (Part A) and one participant received the same daily dose during both dosing periods in Part B.|Part A: 4 hours postdose and Part B: at steady state (14 ± 4 days after the start of each new dosage)|Participants who received at least 1 dose of prasugrel.|||percentage of platelet inhibition||Standard Deviation|Mean
1377822|NCT01476696|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM)|AUC of Pras-AM from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)] is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and is reported for doses administered on site (0.06, 0.08, and 0.12 mg/kg) during Part B (once-daily repeated dosing phase) of the study. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected.|Parts A and B: 0.5, 1, 1.5, 2, 4 hours postdose|Participants who received at least 1 dose of prasugrel.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1377823|NCT01476475|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)|Safety population that included all randomized participants who received at least 1 dose of study medication regardless of the amount of treatment administered.|||percentage of participants|||Number
1377824|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24|Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data.|Week 24|mITT population. Here, number of participants analyzed = participants with any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart or with one of the components (for HbA1c and body weight) showing non-response based on the last post-baseline on-treatment value.|||percentage of participants|||Number
1377825|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Baseline up to Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1377826|NCT01476475|Secondary|Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24|30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1377827|NCT01476475|Secondary|Change in 30-minute and 1-hour PPG From Baseline to Week 24|The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline PPG assessment during on-treatment period. Here, 'n' signifies number of participants with available data for specified category.|||mmol/L||Standard Error|Least Squares Mean
1377828|NCT01476475|Secondary|Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24|On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1377829|NCT01476475|Secondary|Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1377830|NCT01476475|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1377831|NCT01476475|Secondary|Average Daily Insulin Glargine Dose at Week 24|Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with insulin glargine dose measured during on-treatment period|||Units (U)||Standard Error|Least Squares Mean
1377832|NCT01476475|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||kg||Standard Error|Least Squares Mean
1377833|NCT01476475|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1377834|NCT01476475|Secondary|Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24|2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with both baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1377835|NCT01476475|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population.Here, number of participants analyzed = participants with both baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1377947|NCT01475513|Secondary|Change From Baseline in Body Mass Index in 6 Months|Higher values indicate higher metabolic risk|Baseline, 6 months||||Kg/m2||95% Confidence Interval|Mean
1377948|NCT01475513|Secondary|Change From Baseline in HDL at 6 Months|Lower values indicate increased cardiovascular risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
1377836|NCT01476475|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).|Baseline, Week 24|Modified intent-to-treat (mITT) population consisted of all randomized participants received at least 1 dose of IMP and had both baseline and at least 1 post-baseline efficacy assessment. Number of participants analyzed = participants with both baseline and at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1377837|NCT01476345|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Gtot. Participants were analyzed based on the treatment they received.|||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
1377838|NCT01476345|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Rmax. Participants were analyzed based on the treatment they received.|||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
1377839|NCT01476345|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.|||picomoles/Liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1377840|NCT01476345|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.|||picomoles*hour/Liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1377841|NCT01476202|Secondary|Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)|AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique.|||Score on a scale*minutes||95% Confidence Interval|Log Mean
1377842|NCT01476202|Primary|Mean Change From Baseline in Nicotine Craving Score on a VAS|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.|||Score on a scale||Standard Deviation|Mean
1377843|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 7|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377844|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 6|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377845|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377949|NCT01475513|Secondary|Change From Baseline in Systolic Blood Pressure at 6 Months|Higher value indicates increased cardiovascular risk|Baseline, 6 months||||mmHg||95% Confidence Interval|Mean
1377846|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377847|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377848|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 2|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1||||participants|||Number
1377849|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||participants|||Number
1377850|NCT01475955|Secondary|Scaling and Dryness at Visit 7|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377851|NCT01475955|Secondary|Scaling and Dryness at Visit 6|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377852|NCT01475955|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377853|NCT01475955|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377854|NCT01475955|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 2||||participants|||Number
1377855|NCT01475955|Secondary|Scaling and Dryness at Visit 2|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1||||participants|||Number
1377856|NCT01475955|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||participants|||Number
1377857|NCT01475955|Secondary|Stinging/Burning at Visit 7|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377858|NCT01475955|Secondary|Stinging/Burning at Visit 6|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377859|NCT01475955|Secondary|Stinging/Burning at Visit 5 Post PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377860|NCT01475955|Secondary|Stinging/Burning at Visit 5 During PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|during PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377861|NCT01475955|Secondary|Stinging/Burning at Visit 5 (Pre-drug)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 8 prior to drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377862|NCT01475955|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377863|NCT01475955|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377864|NCT01475955|Secondary|Stinging/Burning at Visit 2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|24-48 hours post PDT #1||||participants|||Number
1377865|NCT01475955|Secondary|Stinging/Burning Post Light-Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #1||||participants|||Number
1377866|NCT01475955|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|During PDT #1 (most intense sensation)||||participants|||Number
1377867|NCT01475955|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Baseline||||participants|||Number
1377868|NCT01475955|Secondary|Edema at Week 24|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377869|NCT01475955|Secondary|Edema at Week 12|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377870|NCT01475955|Secondary|Edema Post PDT #2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377871|NCT01475955|Secondary|Edema at Visit 5 (Pre-drug)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377872|NCT01475955|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377873|NCT01475955|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377874|NCT01475955|Secondary|Edema at Visit 2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours post PDT#1||||participants|||Number
1377875|NCT01475955|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1||||participants|||Number
1377876|NCT01475955|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||participants|||Number
1377877|NCT01475955|Secondary|Erythema at Visit 7|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377878|NCT01475955|Secondary|Erythema at Visit 6|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377879|NCT01475955|Secondary|Erythema at Visit 5 (Post-light)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 5 minutes post light treatment|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377880|NCT01475955|Secondary|Erythema at Visit 5 (Pre-drug)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377881|NCT01475955|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377882|NCT01475955|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377883|NCT01475955|Secondary|Erythema at Visit 2|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1||||participants|||Number
1377884|NCT01475955|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1||||participants|||Number
1377885|NCT01475955|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||participants|||Number
1377886|NCT01475955|Secondary|Hypopigmentation at Visit 7|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377887|NCT01475955|Secondary|Hypopigmentation at Visit 6|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377888|NCT01475955|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377889|NCT01475955|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377890|NCT01475955|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377891|NCT01475955|Secondary|Hypopigmentation at Visit 2|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 Hours after PDT #1||||participants|||Number
1377892|NCT01475955|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||participants|||Number
1377893|NCT01475955|Secondary|Hyperpigmentation at Visit 7|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377894|NCT01475955|Secondary|Hyperpigmentation at Visit 6|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377895|NCT01475955|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377896|NCT01475955|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
1377897|NCT01475955|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 2||||participants|||Number
1377898|NCT01475955|Secondary|Hyperpigmentation at Visit 2|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 Hours after PDT #1||||participants|||Number
1377899|NCT01475955|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||participants|||Number
1377900|NCT01475955|Secondary|Subject Satisfaction Score|"0 = no improvement or worsening (not satisfied at all)~= slight improvement (slightly satisfied)~= moderate improvement (moderately satisfied)~= excellent improvement (very satisfied)"|Week 24||||participants|||Number
1377901|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 24||||percent clearance||Standard Deviation|Median
1377902|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 12||||percent clearance||Standard Deviation|Median
1377903|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 8||||percent clearance||Standard Deviation|Median
1377904|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 4||||percent clearance||Standard Deviation|Median
1377905|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline Week 24||||participants|||Number
1377906|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 12||||participants|||Number
1377907|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 8||||participants|||Number
1377908|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 4||||participants|||Number
1377909|NCT01475955|Secondary|Complete Clearance Rate|the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 24||||participants|||Number
1377910|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8||||participants|||Number
1377911|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 4|ITT LOCF|||participants|||Number
1377912|NCT01475955|Primary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data|||participants|||Number
1377913|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, >=6.0 log10) (kilo units per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
1377914|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
1377950|NCT01475513|Secondary|Change From Baseline in Areas-under-the-curve for Glucose|Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk|Baseline, 6 months||||mg/dL * min||95% Confidence Interval|Mean
1377951|NCT01475513|Secondary|Change From Baseline in Areas-under-the-curve for Insulin at 6 Months|Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk|Baselines, 6 months||||mIU/mL * min||95% Confidence Interval|Mean
1377952|NCT01475513|Secondary|Change From Baseline in Fasting Glucose at 6 Months|Higher fasting glucose indicate an increased metabolic risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
1377953|NCT01475513|Secondary|Change From Baseline in Fasting Insulin at 6 Months|Higher fasting insulin values indicate an increased metabolic risk|Baseline, 6 months||||uIU/ mL||95% Confidence Interval|Mean
1377915|NCT01475851|Secondary|Number of Participants With Virological Breakthrough and Resistance-related Mutations|"The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase >=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered negative in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||participants|||Number
1377916|NCT01475851|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg)/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
1377917|NCT01475851|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
1377918|NCT01475851|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
1377919|NCT01475851|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
1377920|NCT01475851|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of investigational product and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.|||participants|||Number
1377921|NCT01475851|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96|The number of participants with serum HBV DNA level < the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 48 and Week 96|FAS Population.|||participants|||Number
1377922|NCT01475851|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation [i.e. 2.1 log10 copies/mL] for the assay were set to the lower limit minus 0.1 [i.e. 2.0 log10 copies/mL]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.|Baseline and Week 24, Week 48 and Week 96|FAS Population|||log10 copies/mL||95% Confidence Interval|Mean
1377923|NCT01475851|Primary|Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24|The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level < the lower limit of quantitation (2.1 log10 copies/millilitres[copies/mL]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA <2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.|Week 24|Full Analysis Set (FAS) Population: all participants who received at least one dose of investigational product (IP) and had at least one efficacy assessment after the start of study treatment.|||participants|||Number
1377924|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
1377925|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
1377926|NCT01475838|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set|||percentage of participants|||Number
1377927|NCT01475838|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: Participants who were randomized and treated, and had no major eligibility criteria violations|||percentage of participants|||Number
1377928|NCT01475734|Secondary|Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period|Treatment-emergent AEs are defined as those with an onset on or after study drug administration. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)|Safety Population: all participants who received one dose of albiglutide or placebo. The Safety Population was analyzed according to treatment received.|||Participants|||Number
1377929|NCT01475734|Secondary|Average Albiglutide Concentration on the Day of the Clamp Procedure|Plasma samples were taken from participants at two time points on Day 4 (at 0 hours and 4 hours and 45 minutes post-dose) of Week 1 of the study for albiglutide study drug level analyses. The average concentration for each participant was calculated as the mean of the concentrations at 0 hours and 4 hours 45 minutes. The clamp procedure is a glucose-controlled insulin infusion system. Variable infusions of glucose are administered to achieve various glucose target levels. It is a way of quantifying insulin secretion and resistance.|Day 4|Albiglutide Pharmacokinetic Population: all participants who had at least one sample to compute albiglutide exposure|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1377930|NCT01475734|Secondary|Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)|The effect of albiglutide and placebo on the recovery time of plasma glucose levels to >=3.9 mmol/L (7>=0 mg/dL) from the hypoglycemic clamp level of 2.8 nmol/L (50.4 mg/dL) was calculated as the time in minutes between switching off of the insulin infusion and reaching the level of >=3.9 mmol/L (>=70 mg/dL). Censored values were censored at 70 minutes. The median and 95% confidence interval data are obtained from Kaplan-Meier estimates.|Day 4|Pharmacodynamic Population|||Minutes||95% Confidence Interval|Median
1377931|NCT01475734|Secondary|C-peptide Values During the Glucose Clamp Period|C-peptide levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
1377932|NCT01475734|Secondary|Cortisol Values During the Glucose Clamp Period|Cortisol levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
1377933|NCT01475734|Secondary|Insulin Values During the Glucose Clamp Period|Insulin levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Picomoles per liter (pmol/L)||Standard Deviation|Geometric Mean
1377934|NCT01475734|Secondary|Growth Hormone Values During the Glucose Clamp Period|Growth hormone levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Micrograms per liter (µg/L)||Standard Deviation|Geometric Mean
1377954|NCT01475513|Secondary|Change From Baseline in Disposition Index at 6 Months|Modeled from FISVGTT--higher values indicate better glucose disposition|Baseline, 6 months||||AIRG * Si||95% Confidence Interval|Mean
1377935|NCT01475734|Secondary|Norepinephrine Values During the Glucose Clamp Period|Norepinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
1377936|NCT01475734|Secondary|Epinephrine Values During the Glucose Clamp Period|Epinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
1377937|NCT01475734|Secondary|Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period|The insulin secretion rate (ISR) was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. ISR was measured at 1 hr, 1 hr 15 min, 1 hr 45 min, 2 hr, 2 hr 45 min, 3 hr, 3 hr 30 min, 3 hr 45 min, 4 hr 15 min, and 4 hr 30 min. Repeated-measures analysis of variance was performed on insulin secretion rate using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect.|Day 4|Pharmacodynamic Population|||Milliunits per hour (mU/hr)||Standard Deviation|Mean
1377938|NCT01475734|Primary|Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure|Plasma glucagon levels were measured for the estimation of glucagon secretion during the hypoglycemic periods. Glucagon response was measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on non-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification (0.03780 nmol/L) were set to the quantification limit for summary.|Day 4|Pharmacodynamic (PD) Population: all participants who received 1 dose of albiglutide or placebo, had a Baseline assessment, and had at least 1 post-Baseline assessment of the primary endpoint (glucagon) during the clamp procedure. PD Population participants were analyzed according to randomly assigned treatment.|||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
1377939|NCT01475721|Secondary|Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours|Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.|From Day 1 up to 26 weeks|mITT Population. Only those participants available at specified timepoint were analysed.|||Number of Puffs||Standard Error|Mean
1377940|NCT01475721|Secondary|Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|mITT Population|||Participants|||Number
1377941|NCT01475721|Secondary|Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death|Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility.|From Day 1 up to 26 weeks|ITT Population|||Participants|||Number
1377942|NCT01475721|Primary|Number of Participants Experiencing at Least One Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment.|||Participants|||Number
1377943|NCT01475721|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.|From Day 1 up to 26 weeks|Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug.|||Participants|||Number
1377944|NCT01475513|Secondary|Change in Triglycerides From Baseline to 6 Months|Higher values indicate higher cardiovascular risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
1377945|NCT01475513|Secondary|Change in LDL From Baseline to 6 Months|Higher value indicates higher cardiovascular risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
1377957|NCT01475513|Primary|Change From Baseline in Carotid Intima Media Thickness|Change in Carotid Intima Media Thickness from baseline to 6 months, measured on the right carotid artery, posterior. Lower values indicate better cardiovascular risk profile|baseline, 6 months|Data based on images. Some participants images could not be analyzed numerically.|||mm||95% Confidence Interval|Mean
1377958|NCT01475513|Primary|Change From Baseline in Flow-mediated Vasodilatation|Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk|Baseline, 6 months|Data based on images. Some participants images could not be analyzed numerically.|||mm||95% Confidence Interval|Mean
1377959|NCT01475513|Primary|Change From Baseline in Insulin Sensitivity|Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity|Baseline, 6 months||||min ^ -1 / mIU / L||95% Confidence Interval|Mean
1377960|NCT01475487|Secondary|Correct Landmarking|Correct landmarking by all participants between the ultrasound and digital palpation group|less than 300 seconds||||participants|||Number
1377961|NCT01475487|Secondary|Number of Attempts|Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.|not more than 300 seconds||||participants|||Number
1377962|NCT01475487|Primary|The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries|The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)).|On avergae less than 300 seconds||||Participants|||Number
1377963|NCT01475487|Secondary|Insertion Time|Defined as palpation of the skin to completion of procedure- cannula in trachea.|less than 5 minutes from starting of procedure||||seconds||Standard Deviation|Mean
1377964|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores.|"The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20.~This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner)."|Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.|||Percentage change||Inter-Quartile Range|Median
1377965|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings.|This co-primary effectiveness endpoint was calculated as a relative percentage of the baseline Accidental Bowel Leakage (ABL) using the following equation: % reduction in ABL = 100*(baseline period ABL - treatment period ABL) / (baseline period ABL)|Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.|||percentage change||Inter-Quartile Range|Median
1377966|NCT01475461|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||participants|||Number
1377967|NCT01475461|Secondary|Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 8 , 12 , 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure and n=participants who were evaluable at given time points for each group.|||kilogram (kg)||Standard Deviation|Mean
1377968|NCT01475461|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||events per participant||Full Range|Median
1377978|NCT01475305|Secondary|Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values|Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values.|Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
1378377|NCT01473524|Primary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg OCA vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 months|Intent-to-Treat Population|||percentage of participants|||Number
1377969|NCT01475461|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||percentage of participants|||Number
1377970|NCT01475461|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1377971|NCT01475461|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator’s discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||participants|||Number
1377972|NCT01475461|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data|Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia’s correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||participants|||Number
1377973|NCT01475461|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.|Week 12|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure.|||percentage of participants|||Number
1377974|NCT01475461|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14||Baseline (Day 1), Week 1, 2, 4, 8, 12, 14|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 1 had not been reported because as per protocol it was not intended to be collected.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1377975|NCT01475461|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline(Day 1), Week 2, 4, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.|||percentage of hemoglobin||Standard Deviation|Mean
1377976|NCT01475461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||percentage of hemoglobin||Standard Deviation|Mean
1377977|NCT01475331|Primary|Number of Participants With the Changing in Cyst Volume|The primary outcome of interest will be change in cyst size, as measured on initial, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution. Cyst size was calculated by measuring x and y diameters and calculating cyst volume using the formula:4/3xpxr3 where r is the average of the cyst radius as measured on the initial, 6-month, and 12-month magnetic resonance imaging or computed tomography. Response was defined according to the same volume percentage reductions as described in previous trials where: complete response is a =>95% reduction in cyst volume, partial response is a 94%-75% reduction, and anon-response is <75% reduction in volume.11 The overall ablation rates in both arms were also compared with historical controls to assess the efficacy of the chemotherapeutic cocktail.|6, and 12 months post procedure|Intent to treat population (all participants at least one dose of intervention)|||Participants|||Count of Participants
1377979|NCT01475305|Secondary|Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)|Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.|From Day 1 through Day 91|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
1377980|NCT01475305|Secondary|Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)|Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported.|From Day 1 through Day 31|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
1377981|NCT01475305|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state.|From Day 1 (immediately following administration of study drug) to Day 360|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
1377982|NCT01475305|Secondary|Percentage of Participants With Positive Anti-MEDI-557 Antibodies|Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater.|Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose|"Population for ADA included all participants who received any amount of investigational product and had >= 1 post-baseline measurement for ADA. Here, n is number of participants analysed at specific time point."|||percentage of participants|||Number
1377983|NCT01475305|Secondary|Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557|The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||day*nanogram per milliliter (d*ng/ml)||Standard Deviation|Mean
1377984|NCT01475305|Secondary|Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557|The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||Day||Standard Deviation|Mean
1377985|NCT01475305|Secondary|Maximum Nasal Wash Concentration (Cmax) of MEDI-557|The Cmax is the maximum observed nasal wash concentration of MEDI-557.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
1377986|NCT01475305|Secondary|Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points|MEDI-557 nasal wash concentrations were summarized by each sampling point [LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash].|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1377987|NCT01475305|Secondary|Mean Clearance of MEDI-557|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||milliliter per day (ml/d)||Standard Deviation|Mean
1377988|NCT01475305|Secondary|Volume of Distribution at Steady-State (Vss) of MEDI-557|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||milliliter (ml)||Standard Deviation|Mean
1377989|NCT01475305|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557|The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||d*mcg/ml||Standard Deviation|Mean
1378034|NCT01474993|Secondary|Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||U/L||Standard Deviation|Mean
1377990|NCT01475305|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557|The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||day*microgram per milliliter (d*mcg/ml)||Standard Deviation|Mean
1377991|NCT01475305|Secondary|Serum Half Life (t1/2) of MEDI-557|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||Day||Standard Deviation|Mean
1377992|NCT01475305|Secondary|Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557|The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||Day||Standard Deviation|Mean
1377993|NCT01475305|Secondary|Maximum Serum Concentration (Cmax) of MEDI-557|The Cmax is the maximum observed serum concentration of MEDI-557.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
1377994|NCT01475305|Secondary|Mean Serum MEDI-557 Concentration Through Day 360|MEDI-557 serum concentrations were summarized by each sampling point [LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum].|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK. Here n = participants evaluable for specified categories, for each arm, respectively.|||microgram per milliliter (ug/mL)||Standard Deviation|Mean
1377995|NCT01475305|Secondary|Duration of Respiratory Syncytial Virus (RSV) Viral Shedding|Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay.|From Day 5 through Day 31|Population for RSV Incidence by any Viral Assay included all participants who received both the investigational product and RSV challenge and were positive for RSV by plaque assay culture, quantitative real-time RT-PCR, or DFA.|||days||Full Range|Median
1377996|NCT01475305|Secondary|Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|RSV infection by plaque assay culture defined as positive sample for >= 2 consecutive days through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for >= 2 consecutive days through 12 days post-RSV challenge).|||log10 copies/mL||Standard Deviation|Mean
1377997|NCT01475305|Secondary|Mean Nasal RSV Peak as Measured by Plaque Assay Culture|RSV infection by plaque assay culture defined as positive sample for >= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter.|From Day 5 through Day 31|Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for >= 1 day through 12 days post-RSV challenge).|||log10 pfu/mL||Standard Deviation|Mean
1377998|NCT01475305|Secondary|Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|RSV infection by plaque assay culture defined as positive sample for >= 2 consecutive days through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for >= 2 consecutive days through 12 days post-RSV challenge).|||log10 copies*day/mL||Standard Deviation|Mean
1377999|NCT01475305|Secondary|Mean Viral Load AUC0-t by Plaque Assay Culture|RSV infection by plaque assay culture defined as positive sample for >= 1 day through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for >=1 day through 12 days post-RSV challenge).|||log10 pfu*day/mL||Standard Deviation|Mean
1378000|NCT01475305|Secondary|Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method|RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for >= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml >= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for >= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for >=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for >= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for >=2 consecutive days through 12 days post-RSV challenge.|From Day 4 to Day 15|Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.|||percentage of participants|||Number
1378001|NCT01475305|Primary|Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture|RSV infection is defined as positive plaque assay culture sample for greater than or equal to (>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter [pfu/mL] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (>) 0 pfu/mL.|From Day 4 to Day 15|Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.|||percentage of participants|||Number
1378002|NCT01475253|Secondary|Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings|Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner’s lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.|Baseline, Day 14|Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||percentage of participants|||Number
1378003|NCT01475253|Secondary|Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score|Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||score on a scale||Standard Deviation|Mean
1378004|NCT01475253|Secondary|Change Form Baseline in O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||score on a scale||Standard Deviation|Mean
1378005|NCT01475253|Secondary|Change From Baseline in Voiding Frequency|Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||Voids||Standard Deviation|Mean
1378006|NCT01475253|Secondary|Change From Baseline in Urinary Urgency as Assessed by VAS|Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words “No Urgency” (best) at the left end (0 cm) and the words “Urgency as bad as you can imagine” (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
1378007|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 42|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
1378008|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 28|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
1378009|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 14|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
1378010|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 7|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
1378224|NCT01474200|Secondary|CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge|Days rehospitalized for HF symptoms requiring hospital, emergency room or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs.|Within 30 days and 90 days after hospital discharge||||Days|||Number
1378011|NCT01475253|Secondary|Percentage of Responders Using the Global Response Assessment (GRA)|Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||Percentage of Responders|||Number
1378012|NCT01475214|Primary|Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen|Describe and compare changes in 24-hour urinary nitrogen in the low and high dose and KHCO3 group and in placebo.|84 days|healthy men and women age 60 years and older|||mmol/day||Standard Error|Mean
1378013|NCT01475214|Primary|The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide|Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses.|84 days|Healthy men and women age 60 years and older|||nmol/day||Standard Error|Mean
1378014|NCT01475175|Secondary|Electrical Conduction During Sub-maximal Exercise.|Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.|Time Frame: Test day visit (within 14 days of enrollment)|||||||
1378015|NCT01475175|Secondary|Cardiac Function With Nominal Settings During Sub-maximal Exercise.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.|Test day visit (within 14 days of enrollment)|||||||
1378016|NCT01475175|Secondary|Cardiac Function With aCRT Settings During Sub-maximal Exercise.|Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.|Test day visit (within 14 days of enrollment)|||||||
1378017|NCT01475175|Secondary|Electrical Conduction at Rest.|Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval. The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.|Test day visit (within 14 days of enrollment)|||||||
1378018|NCT01475175|Secondary|Cardiac Function With Nominal Settings at Rest.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.|Test day visit (within 14 days of enrollment)|||||||
1378019|NCT01475175|Secondary|Cardiac Function With aCRT Settings at Rest|Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.|Test day visit (within 14 days of enrollment)|||||||
1378020|NCT01475175|Primary|Stroke Volume During Sub-maximal Exercise.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.|Test day visit (within 14 days of enrollment)|||||||
1378021|NCT01475175|Primary|Stroke Volume During Atrial Pacing.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.|Test day visit (within 14 days of enrollment)|||||||
1378022|NCT01475175|Primary|Stroke Volume at Rest|Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.|Test day visit (within 14 days of enrollment)|||||||
1378023|NCT01475097|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.|Overall Image Quality rated as ‘Excellent, Adequate or Poor’ by radiologists blinded to the contrast administration.|Within 10 minutes post contrast administration.|"A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis.~This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis."|||participants|||Number
1378024|NCT01475097|Primary|Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography|The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.|Within 10 minutes post contrast administration.|249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol.|||participants|||Number
1378025|NCT01475071|Primary|Pain Score|Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)|Baseline (during procedure), assessed after procedure|ITT population|||units on a scale||Standard Deviation|Mean
1378026|NCT01475071|Primary|Lesion Response|Percent of lesions treated at Baseline, in complete response at Week 12|Week12|Only Per Protocol subjects are included in this analysis|||percentage of lesions complete response||Standard Deviation|Mean
1378027|NCT01474993|Secondary|Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene and Protein Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks||Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks|||||||
1378028|NCT01474993|Secondary|Change From Screening and Baseline in Urinary Isoprostane F2α-VI Levels at 24 Hours After First Dose, at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks||Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks|||||||
1378029|NCT01474993|Secondary|Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||*10^3 cells/µL||Standard Deviation|Mean
1378030|NCT01474993|Secondary|White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||*10^3 cells/µL||Standard Deviation|Mean
1378031|NCT01474993|Secondary|Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||*10^6 cells/µL||Standard Deviation|Mean
1378032|NCT01474993|Secondary|Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||uIU/mL||Standard Deviation|Mean
1378033|NCT01474993|Secondary|Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||mg/dL||Standard Deviation|Mean
1378035|NCT01474993|Secondary|Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Ohio Autism Clinical Impressions Improvement Scale (OACIS-I) is a 10 domain scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.~Each domain is rated on a scale of 1 to 7, where “1” is very much improved; “2” is much improved; “3” is minimally improved; “4” is no change; “5” is minimally worse; “6” is much worse; or “7 is very much worse."|4 weeks, 10 weeks, 18 weeks, 22 weeks||||units on a scale||Standard Deviation|Mean
1378036|NCT01474993|Secondary|Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"OACIS-S is a 10 domain scale that requires the clinician to rate the severity of the patient's autism symptoms at the time of assessment. The 10 domains cover different aspects of patients’ behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.~Each domain is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily."|4 weeks, 10 weeks, 18 weeks, 22 weeks||||units on a scale||Standard Deviation|Mean
1378037|NCT01474993|Secondary|Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of 0 for particular behavior is not a problem at all, 1 indicates that the behavior is a problem but slight in degree, 2 indicates that the problem is moderately serious, and 3 indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome.~For the purposes of this study, ABC scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average ABC scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks, 22 weeks||||units on a scale||Standard Deviation|Mean
1378038|NCT01474993|Primary|Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated on the scoring sheet on a scale from 0 to 3, where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome.~For the purposes of this study, SRS scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average SRS scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks and 22 weeks||||units on a scale||Standard Deviation|Mean
1378039|NCT01474915|Secondary|Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during a delayed period after neurological surgery under general anesthesia.~- Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.~Nausea is evaluated by a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting is evaluated by the investigator or nursing staff numerically as either 0, no vomiting;, 1, mild vomiting;, 2, moderate vomiting;, or 3, severe vomiting."|24 hours post-operatively|Severity of nausea and vomiting|||units on a scale||Full Range|Mean
1378040|NCT01474915|Primary|Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during the first 24 hours after neurological surgery under general anesthesia.~- Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia.~Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia.~Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia."|24 hours post operatively|Number of patients with Complete Control|||participants|||Number
1378041|NCT01474876|Secondary|Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis who received adalimumab treatment|||Percentage of participants|||Number
1378042|NCT01474876|Primary|Percentage of Participants With Peripheral Symptoms in Remission|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)|||Percentage of participants||95% Confidence Interval|Number
1378225|NCT01474200|Secondary|CLINICAL: Length of Stay (LOS) During the Index Hospitalization|Number of days patient is in hospital for HF treatment.|Index hospitalization admission to index hospitalization discharge||||Days||Standard Deviation|Mean
1383987|NCT01422070|Secondary|Length of Hospital Stay|Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital|Max 90 days after admission to the Study Unit||||days||Inter-Quartile Range|Median
1378043|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis|The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with psoriatic arthritis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with psoriatic arthritis who received adalimumab treatment.|||Percentage change||Standard Deviation|Mean
1378044|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
1378045|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)|||Odds Ratio||95% Confidence Interval|Number
1378046|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)|||Correlation coefficient|||Number
1378047|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
1378048|NCT01474876|Secondary|Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis who received adalimumab treatment|||Percentage of participants|||Number
1378065|NCT01474772|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates “does not interfere with sleep” and 10 indicates “completely interferes (unable to sleep due to pain)”. Self-assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378049|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis|Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with ankylosing spondylitis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with ankylosing spondylitis who received adalimumab treatment.|||Percentage change||Standard Deviation|Mean
1378050|NCT01474876|Secondary|Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study|Participants were surveyed at each study visit for their use of NSAID medication.|Baseline (Visit 0) to 12 months|Participants who were receiving NSAID medication at baseline|||Percentage of participants|||Number
1378051|NCT01474876|Secondary|Duration of Treatment With Adalimumab|The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment|||Months||Standard Deviation|Mean
1378052|NCT01474876|Secondary|Mean Frequency of Extra-articular Manifestations (EAMs)|Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn’s disease or ulcerative colitis).|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment|||Mean EAMs per participant||Standard Deviation|Mean
1378053|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
1378054|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)|||Odds Ratio||95% Confidence Interval|Number
1378055|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)|||Correlation coefficient|||Number
1378056|NCT01474876|Secondary|Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
1378057|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
1378058|NCT01474876|Primary|Percentage of Participants With Active Axial Symptoms in Remission|The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)|||Percentage of participants||95% Confidence Interval|Number
1378059|NCT01474876|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)|||Percentage of participants||95% Confidence Interval|Number
1378060|NCT01474876|Primary|Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline|The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of the BASDAI > 4).|||Percentage of participants||95% Confidence Interval|Number
1378061|NCT01474863|Primary|Vasopressor Dependency Index|Worst Value of Index measuring blood pressure hourly through study infusion (day 4). Vasopressor index is mean arterial blood pressure divided by catecholamine index (the catecholamine index is a dimensionless variable calculated as (dopamine dose × 1) + (dobutamine dose × 1) + (adrenaline dose × 10) + (noradrenaline × 100) + (phenylephrine dose × 100), where all doses are expressed in ug/kg/min). (Higher is better)|day 4||||mmHg/catecholamine index||Standard Deviation|Mean
1378062|NCT01474772|Secondary|Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The EQ-5D describes participant`s health status based on 5 attributes producing an 5 digit index score. The 5 dimensions are: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Dolan 1997 advised how to transfer this index score to a single score for clinical trials, a revised single index was published in 2001. The index uses general population weighted estimates for various health states. In general, the range of the single index tends to vary between 0 = death and 1 = perfect health and there are some states that have been rated by the general population to be worse than death which may result in numbers below 0.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378063|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378064|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1379247|NCT01464359|Secondary|Incidence of Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia)|Day 42||||Participants|||Count of Participants
1378066|NCT01474772|Secondary|Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (OS; 7 different scores) and categorized scores (CS; 4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V6).|End of Period 1 (V6)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||percentage of participants|||Number
1378067|NCT01474772|Secondary|Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The autonomic domain score should be summed as follow: Σ(19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378068|NCT01474772|Secondary|Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378069|NCT01474772|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378070|NCT01474772|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378226|NCT01474200|Secondary|EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time|Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.|Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=108 for AQ arm, n=109 for LD arm. 72 hours from baseline: n=81 for AQ arm, n=77 for LD arm. Discharge: n=83 for AQ arm, n=89 for LD arm. 90 days follow up: n=65 for AQ arm, n=76 for LD arm.|||pg/mL||Standard Deviation|Mean
1378071|NCT01474772|Secondary|Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. The symptoms domain score should be summed as follow: Σ(1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378072|NCT01474772|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as –1, “excellent” as –2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as –1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378073|NCT01474772|Secondary|Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|The Walk-12 is a self-administered questionnaire that assesses the impact of the participant’s diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378074|NCT01474772|Secondary|Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||steps||Standard Error|Least Squares Mean
1378075|NCT01474772|Secondary|Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|"Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||counts||Standard Error|Least Squares Mean
1378076|NCT01474772|Secondary|BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378089|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Fine Motor scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.|At baseline visit||||months||Standard Deviation|Mean
1378077|NCT01474772|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378078|NCT01474772|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378079|NCT01474772|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||percentage of participants|||Number
1378080|NCT01474772|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||percentage of participants|||Number
1378081|NCT01474772|Primary|DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)|The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378082|NCT01474772|Post-Hoc|Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The longitudinal mean weekly DPN pain scores were defined as the mean of 7 daily diary pain ratings. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||units on a scale||Standard Deviation|Mean
1378227|NCT01474200|Secondary|EFFICACY: Freedom From Congestion|Defined as jugular venous distention of < or equal to 8 cm, with no orthopnea, and with trace peripheral edema or no edema at hospital discharge|Index Hospitalization, an average of 8 days||||Participants|||Number
1378083|NCT01474772|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the Intent-to-Treat (ITT) analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
1378084|NCT01474746|Secondary|Mullen Scales of Early Learning - Summary Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean summary age-equivalent scores at the 6-month follow-up visit for the placebo and treatment groups are shown here.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||months||Standard Deviation|Mean
1378085|NCT01474746|Secondary|Mullen Scales of Early Learning - Summary Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline summary age-equivalent scores for the placebo and treatment groups are shown here.|At baseline visit||||months||Standard Deviation|Mean
1378086|NCT01474746|Secondary|Mullen Scales of Early Learning - Cognitive T Score Sum|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline and 6-month follow-up visits, and mean cognitive T score sums from the 6-month follow-up visit for the placebo and treatment groups are shown here.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||T scores||Standard Deviation|Mean
1378087|NCT01474746|Secondary|Mullen Scales of Early Learning - Cognitive T Score Sum|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline cognitive T score sums for the placebo and treatment groups are shown here.|At baseline visit||||T scores||Standard Deviation|Mean
1378088|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Fine Motor scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||months||Standard Deviation|Mean
1378164|NCT01474291|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding if accompanied by clinical symptoms, results in a change in study treatment, results in a medical intervention or a change in concomitant therapy or clinically significant in the investigator’s judgment), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 30 months|Safety population, defined as participants who received at least one infusion of tocilizumab.|||percentage of participants|||Number
1378090|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
1378091|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Visual Reception scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||months||Standard Deviation|Mean
1378092|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Visual Reception scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.|At baseline visit||||months||Standard Deviation|Mean
1378093|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Visual Reception scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
1378094|NCT01474746|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the 6-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At six-month visit|This assessment was only introduced to the protocol partway through the trial. As such, only 20 subjects (10 placebo, 10 active) were administered the Vineland-2 at both baseline and follow-up visits.|||units on a scale||Standard Deviation|Mean
1378095|NCT01474746|Secondary|Sensory Profile - Sensation Seeking Subscale Raw Score|"The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver’s sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the Sensation Seeking subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others."|At six-month visit|The Sensory Profile assessment was not administered to any subjects at the follow-up visit due to revisions to the protocol.||||||
1378096|NCT01474746|Secondary|Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score|The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). The SPM-P was administered to the caregiver at baseline and again at the 6-month follow-up visit. Reported here is the Social Participation subscale mean raw score from the 6-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At six-month visit|2 subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. 3 subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent. The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 4 placebo and 3 treatment recipients at the 6-month visit.|||units on a scale||Standard Deviation|Mean
1378228|NCT01474200|Secondary|EFFICACY: Time to Freedom From Congestion|Time from hospital admission to time patient is free of congestion in the hospital. Freedom from congestion is defined as jugular venous distention of < or equal to 8 cm, with no orthopnea and with trace peripheral edema or no edema. Measurement taken every 24 hours after treatment initiation.|Index Hospitalization, an average of 8 days||||Days||Standard Deviation|Mean
1378097|NCT01474746|Secondary|Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score|The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child’s attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the 6-month follow-up visit.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
1378098|NCT01474746|Secondary|Eye Tracking|There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the 6-month follow-up visit.|At six-month visit|Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.|||seconds||Standard Deviation|Mean
1378099|NCT01474746|Secondary|The Visual Analog Scale|"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with “worst behavior” at 0 cm and best behavior” at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at the 6-month visit. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At six-month visit|"Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. An additional subject from the sertraline arm was not administered this measure at the 6-month visit due to staff oversight.~Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent"|||units on a scale||Standard Deviation|Mean
1378100|NCT01474746|Secondary|The Autism Diagnostic Observation Schedule (ADOS-2)|The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.|At six month visit|The ADOS was not administered to all subjects at the six-month visit due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, the ADOS remained listed in the protocol. Also, 2 sertraline and 3 placebo subjects discontinued and were thus administered no follow-up ADOS.|||units on a scale||Standard Deviation|Mean
1378101|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the baseline visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.|At baseline visit||||units on a scale||Standard Deviation|Mean
1378102|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline raw scores from the Visual Reception scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.|At baseline visit||||units on a scale||Standard Deviation|Mean
1378103|NCT01474746|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At baseline visit|This assessment was introduced to the protocol partway through the study, and therefore there were only 20 subjects (10 placebo and 10 active) who were administered the Vineland-II at both their baseline and follow-up visits.|||units on a scale||Standard Deviation|Mean
1378104|NCT01474746|Secondary|Sensory Profile - Sensation Seeking Subscale Raw Score|"The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver’s sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the Sensation Seeking subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others."|At baseline visit|The Sensory Profile was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.|||units on a scale||Standard Deviation|Mean
1378105|NCT01474746|Secondary|Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score|The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At baseline visit|The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 1 subject in the active treatment group at baseline.|||units on a scale||Standard Deviation|Mean
1378106|NCT01474746|Secondary|Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score|The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child’s attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit.|At baseline visit||||units on a scale||Standard Deviation|Mean
1378107|NCT01474746|Secondary|Eye Tracking|There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the baseline visit.|At baseline visit|Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.|||seconds||Standard Deviation|Mean
1378108|NCT01474746|Secondary|Visual Analog Scale|"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with “worst behavior” at 0 cm and best behavior” at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At baseline visit||||centimeters||Standard Deviation|Mean
1378109|NCT01474746|Secondary|Autism Diagnostic Observation Schedule|The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.|At baseline visit|The ADOS was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.|||units on a scale||Standard Deviation|Mean
1378110|NCT01474746|Primary|Change in Mullen Scales of Early Learning - Expressive Language Standard T Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately. Shown here are the baseline and 6-month follow-up T scores from the expressive language scale. T scores have a range of 20 to 80, a mean of 50, and a standard deviation of 10. Any child scoring at or below 1.5 standard deviations below the average is considered presenting significant delays. The lower the T score, the worse the outcome. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||T scores||Standard Deviation|Mean
1378111|NCT01474746|Primary|Clinical Global Impression - Improvement|The Clinical Global Impression - Improvement (CGI-I) is used to measure the overall behavioral change of an individual and their therapeutic response. The CGI-I is a 3-item observer-rated scale administered by the physician to the caregiver, who assesses improvement using a 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the caregiver. Shown here are the CGI-I mean scores from the 6-month follow-up visit.|6-month follow-up visit score|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
1378112|NCT01474746|Primary|Change in Mullen Scales of Early Learning - Expressive Language Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit.|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
1378113|NCT01474681|Secondary|Disease Free Survival (DFS) Within One Year|Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause)|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378114|NCT01474681|Secondary|Overall Survival (OS) Within One Year|Number of participants with Overall survival (OS) within one year|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378115|NCT01474681|Secondary|Incidence of Relapse Within One Year|Number of participants with Incidence of relapse within one year|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378116|NCT01474681|Secondary|Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year|Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year|Day 100 and Monnth 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378117|NCT01474681|Secondary|Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year|Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year|Day 100 and Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378118|NCT01474681|Secondary|Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)|Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit|Day 100|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378119|NCT01474681|Secondary|Incidence of Platelet Recovery Within Six Months|Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement.|6 months|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378120|NCT01474681|Secondary|Incidence of Neutrophil Recovery Within 42 Days|Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC > 0.5 x 109/L which occurred for all patients before 42 days post transplant.|42 days|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378121|NCT01474681|Primary|Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.|The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity – AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.|32 days|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
1378122|NCT01474590|Primary|The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements|"Overall success is reached when the 2 following criteria are fulfilled :~Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment~Safe treatment: Absence of any listed safety issues"|20 weeks||||count of participants|||Number
1378123|NCT01474551|Primary|Overall Objective Response|The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.|2 years||||participants|||Number
1378124|NCT01474538|Secondary|Percentage of Participants With Hypoglycemic Events|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.|||percentage of participants|||Number
1378125|NCT01474538|Secondary|Change From Baseline in Weight|Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%), baseline weight and participants.|Baseline, Week 16 of treatment Periods 1 and 2|All randomized participants who received at least 1 dose of study drug and had weight measured at baseline and Week 16 of Treatment Period 1 or 2. Participants were analyzed based on the treatment they received.|||kilograms (kg)||Standard Error|Least Squares Mean
1378126|NCT01474538|Secondary|Rate of Hypoglycemic Events Per 30 Days|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%).|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.|||hypoglycemic events per 30 days||Standard Error|Least Squares Mean
1378127|NCT01474538|Secondary|Total Daily Insulin Dose|Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%) and participants.|Week 16 of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug and had total daily insulin dose recorded during Treatment Period (TP) 1 or 2. If endpoint data was missing for a specific TP, last observation carried forward (LOCF) method was implemented for that respective TP. Participants were analyzed based on the treatment they received.|||units of insulin||Standard Error|Least Squares Mean
1378128|NCT01474538|Primary|Glycosylated Hemoglobin A1C (HbA1c) at Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (>8% or ≤8%) and participants.|After 16 weeks of each treatment (Periods1 and 2)|All randomized participants who received at least 1 dose of study drug and had HbA1c measured at Week 16 of treatment Period 1 or 2. Participants were analyzed based on the treatment they received.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1378129|NCT01474512|Secondary|Percentage of Participants With Anti-ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline through Week 12|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||percentage of participants|||Number
1378130|NCT01474512|Secondary|Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)||Weeks 12 and 24|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had Ctrough ss results at specified time points where the concentration met the definition of being a trough concentration.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1378131|NCT01474512|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps at baseline.|||percentage of participants|||Number
1378132|NCT01474512|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.|||units on a scale||Standard Error|Least Squares Mean
1378133|NCT01474512|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. It comprises 36-items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.|||units on a scale||Standard Error|Least Squares Mean
1378229|NCT01474200|Secondary|EFFICACY: Total Weight Loss During the Index Hospitalization|Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.|Index Hospitalization, an average of 8 days||||lbs||Standard Deviation|Mean
1378134|NCT01474512|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.|||units on a scale||Standard Error|Least Squares Mean
1378135|NCT01474512|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])|WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1378136|NCT01474512|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.|||units on a scale||Standard Error|Least Squares Mean
1378137|NCT01474512|Secondary|Percent of Body Surface Area (BSA) Involvement of Ps|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.|||percentage of body surface||Standard Error|Least Squares Mean
1378138|NCT01474512|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.|||units on a scale||Standard Error|Least Squares Mean
1378139|NCT01474512|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM)."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had at least 1 post-baseline DLQI measurement.|||units on a scale||Standard Error|Least Squares Mean
1378140|NCT01474512|Secondary|Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had an Itch NRS score ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1378141|NCT01474512|Secondary|Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|Maintenance Period Primary Population (MPPP): all randomized participants from Period 2 who achieved sPGA (0, 1), were re-randomized at Week 12 and who received at least 1 dose of study treatment Period 3 period. Participants did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1378142|NCT01474512|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1378143|NCT01474512|Secondary|Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1378144|NCT01474512|Primary|Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
1378145|NCT01474512|Primary|Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|"The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
1378146|NCT01474434|Secondary|Adiponectin Level ( Part B)||Part B; Baseline, day 15, day 43 and day 85|The study was terminated based on the interim analysis on Part A, cohort 1 after patients completed Part A. Part B of the study was not commenced.||||||
1378147|NCT01474434|Secondary|C-reactive Protein (CRP) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
1378148|NCT01474434|Secondary|Interleukin-6 (IL-6) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
1378149|NCT01474434|Secondary|Other Related Lipid Parameters (Part A)||Baseline, day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
1378150|NCT01474434|Secondary|Pharmacokinetics of Pradigastat (LCQ908): Plasma Concentration (Part A)||Part A: Day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
1378151|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 2)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour (before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.|||ratio||Standard Error|Geometric Mean
1378165|NCT01474291|Secondary|Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire.|"Participants were asked: If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) unacceptable? The percentage of participants who responded acceptable at each time point is presented."|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.|||percentage of participants|||Number
1378152|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 1)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour(before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.|||ratio||Standard Error|Geometric Mean
1378153|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 2)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.|||Participants|||Number
1378154|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 1)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.|||Participants|||Number
1378155|NCT01474434|Primary|Aortic Plaque Inflammation (Part B)|This endpoint was palnned for analysis on Part B patients which was never started becasue study got terminated on Part A interim analysis.|Baseline and on treatment day 85 +/- 3 days|The study was terminated based on the interim analysis after patients completed Part A. Part B of the study was never started.||||||
1378156|NCT01474434|Primary|Time to Onset of Exercise-induced Ischemia(Part A, Cohort 1)|Exercise-induced ischemia was defined as the new development of horizontal or down-sloping ST-segment depression (≥ 1mm at 60 milliseconds after the J point) versus baseline tracings.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .||||||
1378157|NCT01474434|Primary|Time to Onset of Angina (Part A, Cohort 1)|Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the patient and recorded by the performing investigator.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .||||||
1378158|NCT01474434|Primary|Change From Baseline in Total Exercise Duration (Part A, Cohort 1)|Total exercise duration was the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline and on day 5 of each of the two treatment periods|Efficacy analysis set- Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of total exercise duration at both baseline and post-treatment visits. Patients who had no baseline or post-treatment exercise duration data in 1 of 2 periods were excluded from the analysis.|||minute||Standard Error|Least Squares Mean
1378159|NCT01474434|Primary|Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)|MPRi (myocardial perfusion reserve index) is a measure of coronary microvascular function. Myocardial perfusion scans using 0.05 mmol/kg of gadolinium contrast were acquired at rest and under stress (pharmacological stress induced with adenosine 140 μg/kg/min for three minutes). An independent central reader performed the cardiac image analysis of all time points including the calculation of the myocardial perfusion reserve index from the ratio of the global stress myocardial blood flow divided by the resting blood flow values. Higher/increased index indicates improved flow/better outcome. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline, and on day 5 of each of the two treatment periods|Efficacy analysis set - Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of MPRi at both baseline and post-treatment visits. Patients who had no baseline or post-treatment MPRi data in 1 of 2 periods were excluded from the analysis.|||myocardial perfusion reserve index||Standard Error|Least Squares Mean
1378160|NCT01474317|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?'|1 hour||||participants|||Number
1378161|NCT01474317|Secondary|Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<75mg/dL YSI venous plasma) or +/- 5to20% (>=75mg/dL YSI venous plasma).|1 hour|Venipuncture was unsuccessful for one subject. 223 (224-1) venous blood test results were analyzed.|||percentage of meter test results|||Number
1378162|NCT01474317|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for 3 subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.|||percentage of meter test results|||Number
1378163|NCT01474317|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.|||percentage of meter test results|||Number
1378166|NCT01474291|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score|The RAID questionnaire is a participant-reported outcome measure evaluating the impact of rheumatoid arthritis on participant quality of life. This composite index score ranges from 0 (best) to 10 (worst) and includes questions regarding 7 domains (pain, functional disability assessment, fatigue, sleep, physical well-being, emotional well-being, coping). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6, Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.|||units on a scale||Standard Deviation|Mean
1378167|NCT01474291|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI is a participant-reported assessment of ability to perform daily living activities. This composite index score ranges from 0 (normal) to 3 (total functional disability) and includes questions regarding 8 domains (dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.|||units on a scale||Standard Deviation|Mean
1378168|NCT01474291|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12|"EULAR response was categorized as good or moderate response and was calculated as the difference between DAS28-ESR scores at baseline and Month 12. DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity.~If diminution from baseline >1.2 and score ≤3.2 at Month 12 = good response~If diminution from baseline >1.2 and score >3.2 at Month 12 = moderate response~If diminution from baseline >0.6 and ≤1.2, and score ≤5.1 at Month 12 = moderate response~If diminution from baseline >0.6 and ≤1.2, and score >5.1 at Month 12 = non-response~If diminution from baseline ≤1.2 at Month 12 = non-response~Participants with missing data were considered as non-response"|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378169|NCT01474291|Secondary|Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12|ACR20/50/70 response was calculated as improvement (from baseline) of at least 20/50/70% (respectively) of tender and of swollen joints, and improvement from baseline of least 20/50/70% (respectively) in at least 3 of the 5 following parameters: participant's pain assessment, patient's global assessment of disease activity, physician’s global assessment of disease activity, health assessment questionnaire disability index (HAQ-DI) score, and ESR (mm/hour) or CRP (mg/L). Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378170|NCT01474291|Secondary|Percentage of Participants With SDAI Remission at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, CRP (mg/L), and the patient’s global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤3.3 was considered to be SDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378171|NCT01474291|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, C-reactive protein (CRP) (milligrams per liter (mg/L)) per , and the patient’s global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤11 was considered to be SDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378172|NCT01474291|Secondary|Percentage of Participants With CDAI Remission at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient’s global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤2.8 was considered to be CDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378173|NCT01474291|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient’s global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤10 was considered to be CDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378174|NCT01474291|Secondary|Percentage of Participants With DAS28-ESR Remission at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of <2.6 was considered to be DAS28-ESR remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378209|NCT01474213|Secondary|Post Operative Visit|visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.|24 hours||||participants|||Number
1378175|NCT01474291|Secondary|Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of ≤3.2 was considered to be DAS28-ESR LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378176|NCT01474291|Secondary|Percentage of Participants With at Least One csDMARD Intensification During the Study|csDMARD intensification was defined as an addition of a csDMARD without suppression of other csDMARD, dose increase of a csDMARD, switch (addition and suppression) of a csDMARD without intolerance, biological abnormality or symptom improvement to the suppressed csDMARD, or modification of the MTX administration route (from oral route to intramuscular/subcutaneous) with dose increase or maintenance.|Up to 30 months|Participants in Efficacy population who received at least 1 infusion of tocilizumab, who met all inclusion/exclusion criteria, and with no permanent discontinuation of tocilizumab treatment over the study period. For efficacy criteria with response/non response values, participants with non-evaluable response were considered as non-responders.|||percentage of participants|||Number
1378177|NCT01474291|Secondary|Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period|The percentage of participants with no modifications (dose modification or discontinuation) is presented.|Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378178|NCT01474291|Secondary|Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period|The percentage of participants who received infusions is presented by category of total infusions received over the study period.|Up to 13.4 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
1378179|NCT01474291|Secondary|Mean Number of Tocilizumab Infusions Over the Study Period||Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||infusions||Standard Deviation|Mean
1378180|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs)|The percentage of participants who discontinued treatment with unspecified csDMARDs prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued treatment with unspecified csDMARDs and with available data.|||percentage of participants|||Number
1378181|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine|The percentage of participants who discontinued hydroxychloroquine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued hydroxychloroquine and with available data.|||percentage of participants|||Number
1378182|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine|The percentage of participants who discontinued sulfasalazine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued sulfasalazine and with available data.|||percentage of participants|||Number
1378183|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide|The percentage of participants who discontinued leflunomide treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued leflunomide and with available data.|||percentage of participants|||Number
1378184|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)|"The percentage of participants who discontinued MTX treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.~Reason for discontinuation Other Intolerance = intolerance other than cytopenia or hepatic cytolysis."|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued MTX and with available data.|||percentage of participants|||Number
1378185|NCT01474291|Primary|Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion|The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.|Day 1|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||participants|||Number
1378186|NCT01474239|Secondary|Time to WHO PS Deterioration|Time to WHO PS deterioration was defined as the time from randomization to the first date of deterioration of the WHO performance status score. WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.|||months||95% Confidence Interval|Median
1378187|NCT01474239|Secondary|Percentage of Participants With World Health Organization (WHO) Performance Status (PS) Deterioration|WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.|||percentage of participants|||Number
1378230|NCT01474200|Secondary|EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment|Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.|72 hours after treatment initiation||||lbs||Standard Deviation|Mean
1378188|NCT01474239|Secondary|Time to Karnofsky Performance Status (KPS) Deterioration|Time to KPS deterioration was defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Time to KPS deterioration was estimated using Kaplan Meier method. If the participant was not known to have the event, time was censored at the last available visit date.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.|||months||95% Confidence Interval|Median
1378189|NCT01474239|Secondary|Percentage of Participants With Karnofsky Performance Status (KPS) Deterioration|Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.|||percentage of participants|||Number
1378190|NCT01474239|Secondary|Percentage of Participants in Each Class of Corticosteroid Use|Corticosteroid use was classified as: 1. No Change (if corticosteroid dose at each assessment was equal to baseline); 2. Decreased (if corticosteroid dose at each assessment was lower than baseline); 3. Increased (corticosteroid dose at each assessment was greater than baseline).|Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, post-treatment follow-up (up to Day 691)|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."|||percentage of participants|||Number
1378191|NCT01474239|Secondary|Time to Corticosteroid Initiation|Time to corticosteroid initiation was defined as the time from screening to the start date of the first corticosteroid administration in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage ≥2 mg dexamethasone equivalent. Instead, if the participant was not known to have the event, time was censored at the last available visit date. Time to corticosteroid initiation was estimated using Kaplan Meier method.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.|||months||95% Confidence Interval|Median
1378192|NCT01474239|Secondary|Percentage of Participants With Corticosteroid Initiation During the Study Period|Corticosteroid initiation was assessed in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage greater than equal to (>/=) 2 mg dexamethasone equivalent.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.|||percentage of participants|||Number
1378193|NCT01474239|Secondary|Change From Screening in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores at Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|EORTC QLQ-C30: included global health status/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global QOL/functional scales indicates better level of QOL/functioning, or a higher score for symptom scale indicates greater degree of symptoms.|Screening, Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1378194|NCT01474239|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Percentage of participants achieving CR or PR as overall response between first drug administration and documented disease progression were calculated. Tumor response was evaluated according to both the RANO and the Macdonald response criteria. As per Macdonald criteria, CR was defined as the disappearance of all enhancing disease, sustained for at least 4 weeks, and no new lesions along with clinical features of clinically stable or improved, with no corticosteroid; PR was defined as a 50% or more decrease of all measurable enhancing lesions, sustained for at least 4 weeks, and no new lesion along with clinical features of clinically stable or improved, with stable or reduced corticosteroids. RANO criteria defined CR and PR the same as Macdonald criteria with the following additions: CR - improved non enhancing T2/FLAIR lesions; PR - no progression of non-measurable disease, stable or improved non enhancing FLAIR/T2 lesions.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.|||percentage of participants|||Number
1378195|NCT01474239|Secondary|Percentage of Participants Alive 30 Days After Last Dose of Study Drug|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|30 days after last dose of study drug (up to Day 600)|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.|||percentage of participants||95% Confidence Interval|Number
1378196|NCT01474239|Secondary|Percentage of Participants Alive 12 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|12 months|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.|||percentage of participants||95% Confidence Interval|Number
1378197|NCT01474239|Secondary|Percentage of Participants Alive 9 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|9 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
1378198|NCT01474239|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using the RANO or the Macdonald Response Criteria, whichever occurred first. As per RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.|||months||95% Confidence Interval|Median
1378199|NCT01474239|Secondary|Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment|Progression-free survival (PFS) was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using Response Assessment in Neuro-Oncology (RANO) or Macdonald Response Criteria, whichever occurred first. As per the RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per the Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|6 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
1378200|NCT01474239|Primary|Overall Survival (OS)|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|Baseline until death (up to 691 days)|ITT population.|||months||95% Confidence Interval|Median
1378201|NCT01474239|Primary|Percentage of Participants Alive 6 Months After Start of Treatment|Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|6 months|Intent-to-Treat (ITT) population included all randomized participants with at least one administration of the study drug.|||percentage of participants||95% Confidence Interval|Number
1378202|NCT01474213|Secondary|Post Intubation Score|"Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome.~Post-intubation score 1 2 3~Cooperative, obeying commands~Uncomfortable, GA imminent~Other（specify）"|immediately after the intubation||||units on a scale||Inter-Quartile Range|Median
1378203|NCT01474213|Primary|Intubation Score|graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing|during the inserting of the tracheal tube|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.|||units on a scale||Inter-Quartile Range|Median
1378204|NCT01474213|Primary|Endoscopy Scores|"Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition.~Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing"|during the procedure of fibreoptic and tracheal intubation|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.|||units on a scale||Inter-Quartile Range|Median
1378205|NCT01474213|Secondary|Cardiac Rhythm|Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.|15 minutes before intubation and duration of intubation||||participants|||Number
1378206|NCT01474213|Secondary|Peripheral Oxygen Saturation(SPO2)|Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point||||percentage oxygen saturation||Standard Deviation|Mean
1378207|NCT01474213|Secondary|Heart Rate|Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point||||beats per minute||Standard Deviation|Mean
1378208|NCT01474213|Secondary|Mean Arterial Blood Pressure|MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point||||mmHg||Standard Deviation|Mean
1378231|NCT01474200|Secondary|EFFICACY: Net Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.|Index Hospitalization, an average of 8 days||||mL||Standard Deviation|Mean
1378210|NCT01474213|Secondary|Patient's Reaction to Procedure|"Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level.~Clinical score Level of sedation~Patient is anxious and agitated or restless, or both~Patient is cooperative, oriented and tranquil~Patient responds to commands only~Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus~Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus~Patient exhibits no response to stimuli"|the duration of intubation, an expected average of 10 minutes|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.|||units on a scale||Inter-Quartile Range|Median
1378211|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mL/min/1.73m2||Standard Deviation|Mean
1378212|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mg/dL||Standard Deviation|Mean
1378213|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Baseline: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mg/dL||Standard Deviation|Mean
1378214|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient’s serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mg/dL||Standard Deviation|Mean
1378215|NCT01474200|Secondary|CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge|KCCQ Questionnaire analysis based on patient's self-assessment of how they feel at various intervals compared to how they felt prior to index treatment. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=92 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.|||Scores on a Scale||Standard Deviation|Mean
1378216|NCT01474200|Secondary|CLINICAL: Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge|Questionnaire assessed patients quality of life prior to index treatment versus timeframes following hospital discharge. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=91 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.|||Scores on a Scale||Standard Deviation|Mean
1378217|NCT01474200|Secondary|CLINICAL: Days Alive and Out of Hospital at 30 and 90 Days After Discharge|Number of days patients were alive and out of the hospital.|Within 30 and 90 days after hospital discharge||||Days||Standard Deviation|Mean
1378218|NCT01474200|Secondary|CLINICAL: Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.|Death due to any cause.|Time from randomization to 90 days post-hospital discharge||||Percentage of Participants|||Number
1378219|NCT01474200|Secondary|CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days|Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge||||Rehospitalizations/100 Pt-Days at Risk|||Number
1378220|NCT01474200|Secondary|CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.|Within 30 days and 90 days after hospital discharge||||Days|||Number
1378221|NCT01474200|Secondary|CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge||||Rehospitalizations|||Number
1378222|NCT01474200|Secondary|CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge|Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge||||Rehospitalizations|||Number
1378223|NCT01474200|Secondary|CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge|Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs|Within 30 days and 90 days after hospital discharge||||Visits|||Number
1378233|NCT01474200|Primary|Time to First Heart Failure (HF) Event|"Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as~HF rehospitalization or~unscheduled outpatient or emergency room treatment with IV loop diuretics or~unscheduled outpatient Aquapheresis treatment"|90 days after discharge from index HF hospitalization.|Results reported are for the 25th percentile.|||Days||95% Confidence Interval|Median
1378234|NCT01474122|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis – Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Units on a scale||Standard Deviation|Mean
1378235|NCT01474122|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Units on a scale||Standard Deviation|Mean
1378236|NCT01474122|Secondary|Change in Hand Functionality Health Assessment Questionnaire – Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Units on a scale||Standard Deviation|Mean
1378237|NCT01474122|Secondary|Percentage of Participants With at Least One DU Complication|"DU complications were defined as any one of the following:~resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs."|Up to 95 weeks|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Percentage of participants|||Number
1378238|NCT01474122|Secondary|Percentage of Participants Without a New DU up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Percentage of participants|||Number
1378239|NCT01474122|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to Week 16|Full analysis set|||new DUs/16 weeks|||Number
1378240|NCT01474109|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis – Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||units on a scale||Standard Deviation|Mean
1378251|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment||0 to 168 hours after dosing|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.||||||
1379307|NCT01463293|Secondary|Adverse Event Frequency|All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.|4 weeks|||||||
1378241|NCT01474109|Secondary|Health Assessment Questionnaire – Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||units on a scale||Standard Deviation|Mean
1378242|NCT01474109|Secondary|Change in Hand Functionality Health Assessment Questionnaire – Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||units on a scale||Standard Deviation|Mean
1378243|NCT01474109|Secondary|Percentage of Participants With at Least One DU Complication|DU complications were defined as any one of the following, resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.|Up to approximately 90 weeks|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||percentage of participants|||Number
1378244|NCT01474109|Secondary|Percentage of Participants Without a New DU Up To Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to week 16|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||Percentage of participants|||Number
1378245|NCT01474109|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to week 16|Full analysis set|||number of new DUs/observation days|||Number
1378246|NCT01473992|Primary|Physical Functional Performance (Continuous Scale; 10-items)|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.||||scores on a scale||Standard Deviation|Mean
1378247|NCT01473992|Secondary|Prosthesis Evaluation Questionnaire: Utility Score.|The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||score on a scale||Full Range|Median
1378248|NCT01473992|Secondary|Balance and Stability|Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||scores on a scale||Standard Deviation|Mean
1378249|NCT01473992|Primary|75 Meter Self Selected Walking Test|Time to Complete a 75 meter walking distance.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||seconds||Standard Deviation|Mean
1378250|NCT01473953|Secondary|Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up||Day 0 and Day 21|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.|||participants|||Number
1378252|NCT01473953|Secondary|Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment||1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.|||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
1378253|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. This evaluation was not done on placebo cohort.|||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
1378254|NCT01473953|Secondary|Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.|||hours||Geometric Coefficient of Variation|Geometric Mean
1378255|NCT01473953|Secondary|Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
1378256|NCT01473953|Primary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.|Day 0 and up to 21 days after treatment|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.|||events|||Number
1378257|NCT01473836|Secondary|Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole|Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.|Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.|No population pharmacokinetic analysis results are available just for the current study.||||||
1378258|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Investigator Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1378259|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Data Review Committee Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1378260|NCT01473836|Secondary|Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)|"The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; number of participants assessed as continuation over total number of participants that excluding ones assessed as indeterminate multiplied by 100."|Baseline to Day 4|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants|||Number
1378269|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Extended Approach)|Any changes in the participant’s usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Error|Least Squares Mean
1378403|NCT01473420|Primary|Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period||Week 30 up to Week 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
1378261|NCT01473836|Secondary|Clinical Response: Response Rate (Investigator Assessment)|"Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting effective” criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1378262|NCT01473836|Primary|Clinical Response: Response Rate (Data Review Committee Assessment)|"Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting effective” criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1378263|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Extended Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||meters/second||Standard Error|Least Squares Mean
1378264|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Initial Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||meters/second||Standard Error|Least Squares Mean
1378265|NCT01473758|Secondary|Exacerbation Length (Extended Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||days||95% Confidence Interval|Median
1378266|NCT01473758|Secondary|Exacerbation Length (Initial Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||days||95% Confidence Interval|Median
1378267|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Extended Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||hours||Standard Error|Least Squares Mean
1378268|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Initial Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||hours||Standard Error|Least Squares Mean
1378342|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement.|||m/s||Standard Error|Least Squares Mean
1378270|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Initial Approach)|Any changes in the participant’s usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
1378271|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Extended Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Error|Least Squares Mean
1378272|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Initial Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
1378273|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Extended Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||liters/minute||Standard Error|Least Squares Mean
1378274|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Initial Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||liters/minute||Standard Error|Least Squares Mean
1378275|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||scores on a scale||Standard Error|Least Squares Mean
1378276|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
1378277|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Deviation|Mean
1378353|NCT01473563|Secondary|Overall Survival (OS) at 6 Months|The percentage of participants who were alive at Month 6 was calculated as a cumulative percentage by Kaplan-Meier survival analyses approach. For participants not known to have died as of the cut-off date, OS was censored as the last contact date (known alive).|Cycle 1, Day 1 to the date of death from any cause (up to Month 6)|ITT population: Participants who received at least 1 dose of study drug. Twenty-four (24) participants were censored (alive) at the end of the study.|||percentage of participants||95% Confidence Interval|Number
1378278|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Deviation|Mean
1378279|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||scores on a scale||Standard Error|Least Squares Mean
1378280|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
1378281|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Deviation|Mean
1378282|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients’ health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient’s wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Deviation|Mean
1378283|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Extended Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percent||Standard Error|Least Squares Mean
1378284|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Initial Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percent||Standard Error|Least Squares Mean
1378285|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Extended Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||liters||Standard Error|Least Squares Mean
1378286|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Initial Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||liters||Standard Error|Least Squares Mean
1378287|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Extended Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||liters||Standard Error|Least Squares Mean
1378288|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Initial Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||liters||Standard Error|Least Squares Mean
1378289|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Extended Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||mmol/L||Standard Error|Least Squares Mean
1378290|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Initial Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||mmol/L||Standard Error|Least Squares Mean
1378291|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Extended Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||umol/L||Standard Error|Least Squares Mean
1378292|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Initial Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||umol/L||Standard Error|Least Squares Mean
1378293|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Extended Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||mg/L||Standard Error|Least Squares Mean
1378294|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Initial Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||mg/liter(L)||Standard Error|Least Squares Mean
1378295|NCT01473758|Secondary|Change From Baseline in Blood Biomarker IL-1β (Extended Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
1378296|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin-1 Beta (IL-1β) (Initial Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
1379308|NCT01463293|Secondary|Overall Product Satisfaction|At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product’s ability to relieve their constipation symptoms on a 5-point ordinal scale|4 weeks|||||||
1378297|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Extended Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
1378298|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Initial Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
1378299|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||µg/mL||Standard Error|Least Squares Mean
1378300|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||µg/mL||Standard Error|Least Squares Mean
1378301|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||ng/mL||Standard Error|Least Squares Mean
1378302|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||ng/mL||Standard Error|Least Squares Mean
1378303|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
1378304|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
1378305|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
1378306|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
1378307|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocytes (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of lymphocytes||Standard Error|Least Squares Mean
1378308|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocyte (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of lymphocytes||Standard Error|Least Squares Mean
1378309|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of macrophages||Standard Error|Least Squares Mean
1378310|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of eosinophils||Standard Error|Least Squares Mean
1378311|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of macrophages||Standard Error|Least Squares Mean
1378312|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of macrophages||Standard Error|Least Squares Mean
1378332|NCT01473602|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s.~Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|Up to 12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.|||Percentage of participants|||Number
1378313|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction. A negative change from Baseline indicates improvement.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of neutrophils||Standard Error|Least Squares Mean
1378314|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of neutrophils||Standard Error|Least Squares Mean
1378315|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
1378316|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
1378317|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of participants||95% Confidence Interval|Number
1378318|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of participants||95% Confidence Interval|Number
1378319|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
1378320|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Analysis included all participants who received treatment in Cycle 1.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
1378321|NCT01473745|Secondary|1 Nasolabial Angular Parameters|2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®)|up to post-operation 6 months||||degree||Standard Deviation|Mean
1378322|NCT01473745|Secondary|14 Nasolabial Linear Parameters|"baseline characteristics: intercanthulus distance~nasal linear parameters~nasolabial linear parameters"|up to post-operation 6 months||||mm||Standard Deviation|Mean
1378323|NCT01473745|Primary|Soft and Hard Tissue Landmarks Movement|"The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy.~The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery."|The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.|similar sex distribution in both groups (7 male and 17 female patients in Group C, and 8 male and 16 female patients in Group M)|||mm||Standard Deviation|Mean
1378324|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.|||Units on a scale||Standard Error|Least Squares Mean
1378325|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..|||Units on a scale||Standard Error|Least Squares Mean
1378326|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..|||Units on a scale||Standard Error|Least Squares Mean
1378327|NCT01473602|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to Revision Surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 14; placebo = 19.|||Days||Full Range|Median
1378328|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant’s gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement.|||m/s||Standard Error|Least Squares Mean
1378329|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement..|||Units on a scale||Standard Error|Least Squares Mean
1378330|NCT01473602|Secondary|Percentage of Participants Who Regained Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.|||Percentage of participants|||Number
1378331|NCT01473602|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received treatment and had at least 1 nonmissing post-baseline measurement. LOCF values used|||Percentage of participants|||Number
1378375|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 Months|Intent-to-Treat Population|||percentage of participants|||Number
1379309|NCT01463293|Secondary|Stool Consistency|Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form|4 weeks|||||||
1378333|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.|||Percentage of participants|||Number
1378334|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours.. LOCF values used.|||Percentage of participants|||Number
1378335|NCT01473602|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.|||Percentage of participants|||Number
1378336|NCT01473602|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.~Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
1378337|NCT01473602|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized, received at least 1 dose of study drug.|||Percentage of participants||90% Confidence Interval|Number
1378338|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.|Baseline, up to 6 Months|All randomized participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur, and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1378339|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1378340|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1378341|NCT01473589|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to revision surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 51; placebo = 51.|||days||Full Range|Median
1378376|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 months|Intent-to-Treat Population|||percentage of participants|||Number
1379310|NCT01463293|Secondary|Bowel Movement Frequency|Subjects will record the number of defecations per day in a diary.|4 weeks|||||||
1378343|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized and received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1378344|NCT01473589|Secondary|Percentage of Participants Who Regain Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.|||percentage of participants|||Number
1378345|NCT01473589|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.|Up to 12 months|Participants who were randomized and received at least 1 dose of study drug and had at least 1 nonmissing post-baseline measurement. LOCF values used.|||percentage of participants|||Number
1378346|NCT01473589|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.~Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.|||percentage of participants|||Number
1378347|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement. LOCF values used.|||percentage of participants|||Number
1378348|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours. LOCF values used.|||percentage of participants|||Number
1378349|NCT01473589|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received treatment, and had baseline and at least one nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.|||percentage of participants|||Number
1378350|NCT01473589|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.~Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
1378351|NCT01473589|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
1378352|NCT01473563|Secondary|Time to Treatment Failure (TTF)|The time from the date of the first dose of study treatment (Cycle 1, Day 1) to the date of death from any cause, PD (clinical and objective), or discontinuation of pemetrexed due to toxicity. Response was defined using RECIST, v1.1 criteria. PD was defined as having at least a 20% increase in the sum of the longest diameter of target lesions and at a minimum 5 mm increase above nadir. TTF was censored at the date of the last visit for participants who did not discontinue pemetrexed, who were still alive, and who had not progressed.|Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug. Two (2) participants were censored.|||months||95% Confidence Interval|Median
1379311|NCT01463293|Secondary|Adequate Relief of Constipation (Yes/no)|Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.|4 weeks|||||||
1378354|NCT01473563|Secondary|Resource Utilization: Distances Traveled|The distance traveled is reported by region (Great Britain and Sweden) and includes the distance traveled by the participant from his/her home to the hospital (Cycle 1) and other cycles where the homecare nurse traveled from the hospital to the participant's home. Due to the limited number of participants with evaluable data, results are reported for Cycles 1 through 4.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had data for distance traveled for at least 1 cycle from Cycle 1 through Cycle 4.|||kilometers (km)||Standard Deviation|Mean
1378355|NCT01473563|Secondary|Resource Utilization: Duration of Health Care Visits|The duration of the health care visit in the home setting is reported. The visit started when the nurse arrived and included the entire treatment process. The visit ended when the nurse left the home setting. Due to the limited number of participants with evaluable data, results are reported for Cycles 2 through 4.|Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 health care visit in the home setting from Cycle 2 through Cycle 4.|||hours||Standard Deviation|Mean
1378356|NCT01473563|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died|The number of participants who had at least 1 TEAE or serious TEAE (regardless of causality) is reported along with the number of participants who died (due to any cause) while on therapy or during treatment discontinuation follow-up (up to 6 months). TEAEs started on or after the date and time of first dose of study drug, or started prior to study drug but worsened after study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.|First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]|Safety Population: Participants who received at least 1 dose of study drug.|||participants|||Number
1378357|NCT01473563|Secondary|Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services|The unplanned use of any 1 of the following 4 resources is reported, as well as the unplanned use of each resource: accident and emergency dept., specialists (oncologist, pulmonologist etc.), GP or family doctor, and diagnostic procedures. Results are reported as the number of participants with an unplanned resource use (visit) for a specified number of times.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 unplanned use of health care resources.|||participants|||Number
1378358|NCT01473563|Secondary|Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources|The number of participants who had at least 1 unplanned use of health care resources [accident and emergency department (dept.), specialists [oncologist, pulmonologist, etcetera (etc.)], general practitioner (GP) or family doctor, or diagnostic procedures] during the study is reported.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug.|||participants|||Number
1378359|NCT01473563|Secondary|Physician Satisfaction: Distant Management of Participant|"The physician was asked, How would you rate your overall satisfaction with the distant management of the participant during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and for whom the investigator answered the specified question at 30 days post treatment discontinuation.|||investigators|||Number
1378360|NCT01473563|Secondary|Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment|"Participants were asked to evaluate their preferences regarding home and/or hospital treatment delivery in this study by answering 2 questions (Q). Q15: Do you prefer having your chemotherapy at home or at the hospital, or are you indifferent? Choices included: Home, Hospital, or Indifferent. Q16: Would you recommend having chemotherapy at home to someone else in your same situation? Choices included: Yes, No, or Not sure."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
1378361|NCT01473563|Secondary|Participant Satisfaction: Regarding the Study Nurse|"Participants were asked 7 questions (Q) about their study nurse for home treatment. Q8: Was the nurse an easy person to talk to?, Q9: When the nurse came, did you feel he/she had enough time to do the required things?, Q10: Do you think the nurse had time to discuss things with you?, Q11: Did you feel that the nurse knew enough about you and your illness? Choices for Q8 through Q11 included: Yes or No. Q12: Were you able to get all the information you wanted about your illness or treatment? Choices included: Yes, No, or Uncertain. Q13: Would you say that the nurse gave… Choices included: a lot of reassurance and support, some reassurance and support, or hardly any reassurance and support. Q14: How would you rate your overall satisfaction with the nursing staff during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
1378362|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Home|"Participants were asked to evaluate their home treatment experiences in this study by answering 4 questions (Q). Q5: What do you do consider advantages of having chemotherapy at home? Choose all that apply. Choices included: No need to travel, Not having to wait for treatment, Personalized service, More privacy, and Other. Q6:What do you consider disadvantages of having chemotherapy at home? Choose all that apply. Choices included: Lack of other patients’ support, Extra burden for family/friends, Safety concerns, Need to rely on 1 medical specialist, and Other. Q7: How would you rate your overall satisfaction with chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
1378363|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Hospital|"Participants were asked to evaluate their hospital experiences in this study by answering 4 questions (Q). Q1: What do you consider advantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Support from other patients, Access to other medical specialists, Access to more technical services, Safer in case something goes wrong, and Other. Q2: What do you consider disadvantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Need to travel, Having to wait for treatment, Not having a personalized treatment, Lack of privacy on the ward, and Other. Q3: How would you rate your overall satisfaction with chemotherapy at the hospital? and Q4: How would you rate your overall satisfaction with the nursing staff during chemotherapy at the hospital? Choices for Q3 and Q4 included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
1378364|NCT01473563|Secondary|Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores|LCSS is a 9-item questionnaire; 6 items are symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe overall symptomatic distress, interference with activity level, and overall quality of life during the past 24 hours. Participant responses were measured using a VAS with 100-millimeter (mm) lines. Scores ranged from 0 mm (no symptoms and no impact on activities, quality of life) to 100 mm (symptoms as bad as they could be, impacting activities and quality of life).|Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline LCSS assessment.|||mm||Standard Deviation|Mean
1378365|NCT01473563|Secondary|Change From Baseline in the EQ-5D Index Score|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline EQ-5D Index score is reported and the EQ-5D Index score was calculated by converting health state scores into a weighted health state index according to a United Kingdom population-based algorithm. The possible values for the EQ-5D Index score range from −0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), on a scale where 1 represents the best possible health state.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D index assessment.|||units on a scale||Standard Deviation|Mean
1378366|NCT01473563|Secondary|Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline in EQ-5D VAS is reported.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D VAS assessment.|||units on a scale||Standard Deviation|Mean
1378367|NCT01473563|Primary|Percentage of Participants Who Adhered to Treatment Administration at Home|Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation.|Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)|Intention-to-Treat (ITT) population: Participants who received at least 1 dose of study drug. The number of participants censored was 6, 9, 7, 8, 7, 1, 0, 2, 2, 2, 2, 0, 3, 0, 0, 0, 0, 0, and 1 for Cycles 1 through 19, respectively.|||percentage of participants||95% Confidence Interval|Number
1378368|NCT01473524|Secondary|Gamma-glutamyltransferase (GGT) Absolute Change From Baseline to Month 12|Gamma-glutamyltransferase (GGT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
1378369|NCT01473524|Secondary|Aspartate Aminotransferase (AST) Absolute Change From Baseline to Month 12|Aspartate Aminotransferase (AST) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
1378370|NCT01473524|Secondary|Alanine Aminotransferase (ALT) Absolute Change From Baseline to Month 12|Alanine Aminotransferase (ALT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
1378371|NCT01473524|Secondary|Direct Bilirubin Absolute Change From Baseline to Month 12|Direct Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||umol/L||Standard Error|Least Squares Mean
1378372|NCT01473524|Secondary|Total Bilirubin Absolute Change From Baseline to Month 12|Total Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||umol/L||Standard Error|Least Squares Mean
1378373|NCT01473524|Secondary|Alkaline Phosphatase Absolute Change From Baseline to Month 12|Alkaline Phosphatase Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
1378374|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 Months|Intent-to-Treat Population|||percentage of participants|||Number
1379312|NCT01463293|Secondary|Bowel Function Index|The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.|4 weeks|||||||
1378378|NCT01473420|Other Pre-specified|Percentage of Participants With Local Tolerability|Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1378379|NCT01473420|Other Pre-specified|Percentage of Participants With General Tolerability|General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1378380|NCT01473420|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies|Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1378381|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378382|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)|ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378383|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378384|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378385|NCT01473420|Other Pre-specified|Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event|In this outcome measure number of participants discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378386|NCT01473420|Other Pre-specified|Number of Participants With Treatment Related Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378387|NCT01473420|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378388|NCT01473420|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378389|NCT01473420|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.|||percentage of participants|||Number
1378390|NCT01473420|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.|||percentage of participants|||Number
1378391|NCT01473420|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.|||percentage of participants|||Number
1378392|NCT01473420|Secondary|Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period|In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL|Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378393|NCT01473420|Secondary|Percentage of Participants Who Received Blood Transfusions: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||percentage of participants|||Number
1378394|NCT01473420|Secondary|Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period||Week 1 up to Week 18|This outcome measure was planned not to be analyzed in maintenance period. Safety analysis population for titration period included all participants who received at least 1 dose of study treatment in titration period.|||percentage of participants|||Number
1378395|NCT01473420|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period|Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 26, 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||percentage of participants|||Number
1378396|NCT01473420|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.|||percentage of participants|||Number
1378397|NCT01473420|Secondary|Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.|||percentage of participants|||Number
1378398|NCT01473420|Secondary|Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.|||percentage of participants|||Number
1378399|NCT01473420|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period|Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 26, 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||percentage of participants|||Number
1378400|NCT01473420|Secondary|Total Dose of Study Medication Administered: Maintenance Period|In this outcome measure mean of total dose of study medication administered in maintenance period was reported.|Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies number of participants who were evaluable for this outcome measure."|||units of study medication||Standard Deviation|Mean
1378401|NCT01473420|Secondary|Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period||Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies number of participants who were evaluable for this outcome measure."|||U/kg/week||Standard Deviation|Mean
1378402|NCT01473420|Secondary|Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period||Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||g/dL||Standard Deviation|Mean
1378404|NCT01473420|Primary|Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period||Week 30 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Intent-to-treat (ITT) population included all participants who were randomized into the maintenance period.|||g/dL||Standard Deviation|Mean
1378405|NCT01473407|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies|Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.|Week 1 up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1378406|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378407|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)|ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378408|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378409|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378410|NCT01473407|Other Pre-specified|Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event|In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.|Week 1 up to Week 28|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378411|NCT01473407|Other Pre-specified|Number of Participants With Treatment Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Week 1 up to Week 28|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378412|NCT01473407|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).|Week 1 up to Week 28|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378413|NCT01473407|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Week 1 up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
1378414|NCT01473407|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 24|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1378415|NCT01473407|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 24|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1378416|NCT01473407|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level||Week 1 up to Week 24|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1379313|NCT01463293|Secondary|Patient Assessment of Constipation QoL (PAC-QoL)|The PAC-QoL is a 28-question survey that asks questions on their quality of life.|4 weeks|||||||
1378417|NCT01473407|Secondary|Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level|In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL|Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
1378418|NCT01473407|Secondary|Percentage of Participants Who Received Blood Transfusions||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1378419|NCT01473407|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range|Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 12, 24|ITT population included all participants who were randomized to study treatment.|||percentage of participants|||Number
1378420|NCT01473407|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)||Week 1 up to Week 24|Per protocol population was a subset of ITT participants who did not have major protocol violations.|||percentage of participants|||Number
1378421|NCT01473407|Secondary|Percentage of Participants Who Required Temporary Dose Changes of Study Medication||Week 1 up to Week 24|Per protocol population was a subset of ITT participants who did not have major protocol violations.|||percentage of participants|||Number
1378422|NCT01473407|Secondary|Percentage of Participants Who Required Permanent Dose Changes of Study Medication||Week 1 up to Week 24|Per protocol population was a subset of ITT participants who did not have major protocol violations.|||percentage of participants|||Number
1378423|NCT01473407|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range|Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 12, 24|ITT population included all participants who were randomized to study treatment.|||percentage of participants|||Number
1378424|NCT01473407|Secondary|Total Dose of Study Medication Administered||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||units of study medication||Standard Deviation|Mean
1378425|NCT01473407|Secondary|Mean Weekly Dosage of Study Medication Through 24 Weeks||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||U/kg/week||Standard Deviation|Mean
1378426|NCT01473407|Secondary|Mean Weekly Hemoglobin Level Through 24 Weeks||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||g/dL||Standard Deviation|Mean
1378427|NCT01473407|Primary|Mean Weekly Dosage of Study Medication From Week 21 to Week 24||Week 21 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, Number of Participants Analyzed (N) signifies those participants who were evaluable for this outcome measure."|||unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
1378428|NCT01473407|Primary|Mean Weekly Hemoglobin Level From Week 21 to Week 24||Week 21 up to Week 24|ITT population included all participants who were randomized to study treatment.|||g/dL||Standard Deviation|Mean
1378429|NCT01473394|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate|The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.|||Percentage of participants||95% Confidence Interval|Number
1378430|NCT01473394|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8|The CGI-S is a clinician-rated scale for assessing the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question “Considering your total clinical experience with this population, how mentally ill is the participant at this time?” on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
1378431|NCT01473394|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
1378446|NCT01473160|Primary|Average Ocular Surface Temperature|Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.|Up to 16 hours after lens insertion|All enrolled participants|||Degrees Celsius||Standard Deviation|Mean
1379314|NCT01463293|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM)|The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.|4 weeks|||||||
1378432|NCT01473381|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.|||Percentage of participants||95% Confidence Interval|Number
1378433|NCT01473381|Secondary|Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score|The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant’s current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: “Considering your total clinical experience with this population, how mentally ill is the patient at this time?” The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
1378434|NCT01473381|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
1378435|NCT01473368|Primary|Operational Taxonomic Units|"Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day 0 to Day 21||||units||Standard Deviation|Mean
1378436|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21||||percentage of total bacteria||Standard Deviation|Mean
1378437|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21||||percentage of total bacteria||Standard Deviation|Mean
1378438|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21||||percentage of total bacteria||Standard Deviation|Mean
1378439|NCT01473368|Primary|Gastrointestinal Symptoms Response Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 21|Participants analyzed were those with complete data at Day 14|||units on a scale||Standard Deviation|Mean
1378440|NCT01473368|Primary|Gastrointestinal Symptoms Response Score|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 14|Participants analyzed were those with complete data at Day 14|||units on a scale||Standard Deviation|Mean
1378441|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 7||||Units on a scale||Standard Deviation|Mean
1378442|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 0|Control participants were not assessed at this time point.|||units on a scale||Standard Deviation|Mean
1378443|NCT01473160|Secondary|Number of Participants With Adequate Lens Fit|Lens fit was assessed by the investigator with a biomicroscope (slit lamp).|Up to 16 hours after lens insertion|All enrolled participants|||Participants|||Number
1378444|NCT01473160|Secondary|Subjective Vision|"Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, What is the quality of your vision with the lens at present?"|Up to 16 hours after lens insertion|All enrolled participants|||Units on a scale||Standard Deviation|Mean
1378445|NCT01473160|Secondary|Subjective Comfort|"Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, How comfortable is the lens feeling at present?"|Up to 16 hours after lens insertion|All enrolled participants|||Units on a scale||Standard Deviation|Mean
1378447|NCT01473160|Primary|Average Tear Meniscus Height|The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.|Up to 16 hours after lens insertion|All enrolled participants|||pixels||Standard Deviation|Mean
1378448|NCT01473160|Primary|Pre-Lens Noninvasive Tear Break-Up Time|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.|Up to 16 hours after lens insertion|All enrolled participants|||seconds||Standard Deviation|Mean
1378449|NCT01473160|Primary|Number of Participants With Corrected Visual Acuity of 0.0 or Better|Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.|Up to 16 hours after lens insertion|All enrolled participants|||participants|||Number
1378450|NCT01472965|Secondary|Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record. The percentage of evaluable participants with any potentially attributable adverse effect is reported.|Up to 37.5 weeks after the start of treatment.||||percentage of participants|||Number
1378451|NCT01472965|Secondary|Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Occlusion was defined as central line occlusion or dysfunction requiring thrombolytic therapy. The percentage of evaluable participants requiring thrombolytic therapy for central line occlusion is reported.|Up to 26 weeks after the start of treatment.||||percentage of participants|||Number
1378452|NCT01472965|Secondary|Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Reinfection was defined as new CLABSI with a different organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with reinfection is reported.|Up to 25 weeks after the start of treatment.||||percentage of participants|||Number
1378453|NCT01472965|Secondary|Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Relapse was defined as new CLABSI with an identical organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with relapse is reported.|Up to 25 weeks after the start of treatment||||percentage of participants|||Number
1378454|NCT01472965|Secondary|Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Therapeutic failure was a pre-defined composite outcome comprising either ‘early failure’: central line removal, death, persistent positive blood cultures for >72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or ‘late failure’: relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The cumulative incidence of therapeutic failure is reported.|Up to 25 weeks after the start of treatment||||percentage of participants|||Number
1378455|NCT01472965|Primary|Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard Care Alone|Therapeutic failure was a pre-defined composite outcome comprising either ‘early failure’: central line removal, death, persistent positive blood cultures for >72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or ‘late failure’: relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The percentage of evaluable participants with therapeutic failure is reported.|Up to 25 weeks after the start of treatment.||||percentage of participants|||Number
1378456|NCT01472939|Secondary|Time to Maximum Plasma Concentration (Tmax) of SSP-002358||Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.|||hours||Full Range|Median
1378457|NCT01472939|Secondary|Steady State Maximum Plasma Concentration (Cmax) of SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.|||pg/ml||Standard Deviation|Mean
1378458|NCT01472939|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358|Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.|||pg*h/ml||Standard Deviation|Mean
1378459|NCT01472939|Secondary|Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8|PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.|Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1378460|NCT01472939|Secondary|Change From Baseline in Heartburn-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of days||Standard Error|Least Squares Mean
1378461|NCT01472939|Primary|Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of days||Standard Error|Least Squares Mean
1378462|NCT01472874|Secondary|Zn Urine||Months 1,2,3,6,9,12 (mean)||||mcg/24hr||Standard Deviation|Mean
1378470|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Months 1,2,3,6,9,12 (mean)||||international normalized ratio||Standard Deviation|Mean
1378471|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Pre Treatment (mean)||||international normalized ratio||Standard Deviation|Mean
1378472|NCT01472874|Primary|ALT|Alanine transaminase|Months 1,2,3,6,9,12 (mean)||||U/L||Standard Deviation|Mean
1378473|NCT01472874|Primary|ALT|Alanine transaminase|Pre Treatment (mean)||||U/L||Standard Deviation|Mean
1378474|NCT01472835|Secondary|Satisfaction|5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.|1 day||||units on a scale||Standard Deviation|Mean
1378475|NCT01472835|Secondary|Oswestry Disability Index|Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability|1-month||||units on a scale||Standard Deviation|Mean
1378476|NCT01472835|Secondary|Procedure-related Pain Score|0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable|1 day||||units on a scale||Standard Deviation|Mean
1378477|NCT01472835|Secondary|Pain Score|0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.|1-month||||units on a scale||Standard Deviation|Mean
1378478|NCT01472835|Primary|Pain Score|pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable|through 6 hours after injection||||units on a scale||Standard Deviation|Mean
1378479|NCT01472822|Secondary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
1378480|NCT01472822|Secondary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||ng/ml||Standard Deviation|Mean
1378481|NCT01472822|Secondary|Changes in Hs-CRP(High Sensitivity C-reactive Protein)|hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/L||Standard Deviation|Mean
1378482|NCT01472822|Secondary|Changes in Lysholm Index Score|"Lysholm index score total score (score 0–100) was measured in study visit 1(0 week) and visit 3(12 week).~The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best)."|12 weeks|per protocol analysis|||units on a scale(0-100)||Standard Deviation|Mean
1378483|NCT01472822|Primary|Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score|"WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0–96) was measured in study visit 1(0 week) and visit 3(12 week).~The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst)."|12 weeks|per protocol analysis|||Score||Standard Deviation|Mean
1378484|NCT01472562|Secondary|2-year Progression-free Survival|PFS will be defined as the time from first treatment day until objective or symptomatic progression or death.|30 months||||percentage of patients||95% Confidence Interval|Number
1378485|NCT01472562|Primary|Overall Response Rate|The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.|30 months||||percentage of patients||95% Confidence Interval|Number
1378486|NCT01472549|Secondary|Cost Savings||30 days|Cost data was not collected because it as not logistically feasible.||||||
1378487|NCT01472549|Secondary|Number of Participants With Skin Contamination After Skin Prep||1 day|The skin samples collected could not be processed for financial reasons.||||||
1378488|NCT01472549|Secondary|Number of Participants With Allergic Reaction||30 days||||Participants|||Count of Participants
1378489|NCT01472549|Secondary|Number of Participants With Skin Irritation||30 days||||Participants|||Count of Participants
1378490|NCT01472549|Secondary|Number of Participants With Endometritis||30 days||||Participants|||Count of Participants
1378491|NCT01472549|Secondary|Number of Participants With Re-admissions or Office Visits for Wound-related Problems||30 days||||Participants|||Count of Participants
1378492|NCT01472549|Secondary|Length of Hospital Stay||30 days||||days||Inter-Quartile Range|Median
1378493|NCT01472549|Primary|Number of Participants With Surgical Site Infection|Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.|30 days||||Participants|||Count of Participants
1378494|NCT01472432|Secondary|iNOS|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue||||||
1378495|NCT01472432|Secondary|VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form)|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue||||||
1378496|NCT01472432|Secondary|VEGF|The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor.|3 months||||arbitrary units||Inter-Quartile Range|Median
1378497|NCT01472432|Secondary|HIF-1α|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor.|3 months||||arbitrary units||Inter-Quartile Range|Median
1378498|NCT01472432|Primary|Capillary Density|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.~Capillary density is measured using immunohistochemistry"|3 months of treatment with vildagliptin||||capillaries/mm2||Inter-Quartile Range|Median
1378499|NCT01472432|Primary|Full Epithelialization of the Wound|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.~Optic microscopy is used to evaluate the epithelialization of the wound."|3 months of treatment with vildagliptin||||participants|||Number
1378500|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0 to infinity)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to infinity for efavirenz.|||h*ug/mL||Standard Deviation|Mean
1378501|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t) for efavirenz.|||h*ug/mL||Standard Deviation|Mean
1378502|NCT01472380|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the maximum concentration (Cmax)for efavirenz.|||ug/mL||Standard Deviation|Mean
1378503|NCT01472341|Primary|Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline|Participants with fasting plasma insulin and glucose concentration assessments at baseline.|||Percentage Beta Cell Function||Standard Deviation|Mean
1378504|NCT01472341|Primary|Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years|Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline and Year 4|Participants who had laboratory parameters at Baseline and at Year 4.|||PI/I||Standard Deviation|Mean
1378505|NCT01472341|Primary|Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5.|Baseline and 4 years|Participants who had laboratory parameters at Baseline and at Year 4.|||Percentage of Beta Cell Function||Standard Deviation|Mean
1378506|NCT01472289|Secondary|Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test|Subjects were analyzed to see if they were able to walk any distance and the distance covered by patients in 6 minutes was measured to assess the functional changes from baseline. The American Thoracic Society has issued guidelines for the 6-minute walk test (6 MWT). The 6 MWT is safe, easy to administer, well tolerated, and reflects activities of daily living.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Participants|||Number
1378507|NCT01472289|Secondary|Clinical Evaluation for the Presence of Ulcer and/or Gangrene in the Affected Limb From Baseline to 12 Months|Evaluation of the integument for ulceration, gangrene and other skin changes in the affected limb was performed at baseline and follow-up visits at 1 month, 3 months, 6 months, and 12 months.The ulceration and gangrene in the affected limb of the subjects was evaluated by visual clinical inspection.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Participants|||Number
1378508|NCT01472289|Secondary|Change in Rest Pain and Intermittent Claudication Assessment From Baseline to 12 Months|"Rest pain is a burning sensation felt at rest, usually in the skin of the foot. It is a symptom of critical ischemia due to severe, chronic, and occlusive peripheral arterial disease (PAD). While, Intermittent Claudication is a crampy leg pain that occurs during exercise, especially walking. The pain is due to the insufficient blood flow in the legs (caused by blocked arteries). Intermittent claudication is the most prominent symptom of PAD.~Both Rest Pain assessment and Intermittent Claudication assessment was performed through Visual Analog Scale or Visual Analogue Scale (VAS). VAS is a psychometric (self-report) response scale that ranges from 0 to 10, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain."|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||scores on a scale||Standard Deviation|Mean
1378509|NCT01472289|Secondary|Measurement of Change in Transcutaneous Oxygen Pressure (TcPO2) From Baseline to 12 Months|TcPO2 was used to assess the partial pressure (tension) of oxygen in the capillaries of tissues of lower limbs. It was measured by applying a special set of electrodes to the skin. These electrodes contain photoelectric sensors capable of detecting the specific wavelengths of radiation emitted by oxygenated versus reduced hemoglobin.|Baseline, 1, 3, 6 and 12 months|The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||mmHg||Standard Deviation|Mean
1378510|NCT01472289|Secondary|Measurement of Mean Change in Ankle Brachial Index From Baseline to 12 Months|ABI was used to provide a measure of blood flow in the lower limbs. It is the ratio of the blood pressure in the lower limbs to the blood pressure in the upper limbs. Compared to the upper limb, lower blood pressure in the lower limb is an indication of blocked arteries (peripheral vascular disease). The ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. ABI test was performed at baseline, 1 month, 3 months, 6 months, and 12 months.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Ratio||Standard Deviation|Mean
1378511|NCT01472289|Secondary|Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months|Measurement of blood supply facilitated by the formation of collateral blood vessels assessed by CT angiography after the procedure.|Baseline and 12 month|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Number of Vessels||Standard Deviation|Mean
1378512|NCT01472289|Primary|Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration|The Primary objective of this study was to determine the safety of intramuscular administration of concentrated autologous BMMNCs harvested, and processed using the Res-Q 60 technology (a point-of-care system). Safety measurements included close vigilance for major limb amputation free survival at 1, 3, 6 and 12 months post BMMNCs administration and stringent reporting of AEs and SAEs.|1, 3, 6 and 12 Months|All the safety end points in the study were analyzed on the ITT population. Out of 17 subjects, adverse events were reported for seven subjects. Of the seven subjects, three underwent major amputation, two reported minor amputation, and two died due to cardiac arrest (unrelated death). Furthermore, major limb amputation free survival rate was 14.|||participants|||Number
1378513|NCT01472185|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1378514|NCT01472185|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at time [T] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1378515|NCT01472185|Secondary|Percentage of Participants With HbA1c < 7% at Week 24||Week 24|Participants in the Full Analysis Set with Baseline HbA1c ≥ 7% and available data were analyzed.|||percentage of participants|||Number
1378516|NCT01472185|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
1378517|NCT01472185|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding subjects with major eligibility violations and analyzed based on the randomized treatment regardless of actual treatment received) with available data were analyzed.|||percent of HbA1c in blood||Standard Deviation|Mean
1378518|NCT01471782|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α) and interferon gamma (IFN-ɣ) using cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the lower limit of quantification (LLOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.|Cycle 1 and 2 day 1 (prior to infusion, 2 and 6 hours after infusion start), day 2 and day 3.|Phase 1 full analysis set participants with available data|||pg/mL||Standard Deviation|Mean
1378519|NCT01471782|Secondary|Number of Participants Who Developed Anti-blinatumomab Antibodies|Antibodies to blinatumomab were detected using an electrochemiluminescence (ECL)-based assay.|Predose up until 30 days after last dose of study medication; median treatment duration was 28 days.|Full analysis set|||participants|||Number
1378520|NCT01471782|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant During Blinatumomab Induced Remission|The percentage of participants who received allogeneic hematopoietic stem cell transplantation (HSCT) while in remission due to treatment with blinatumomab during the first two cycles, and received no further anti-leukemic medication before HSCT.|Up to the data cut-off date of 12 January 2015; Maximum duration on study was 24 months in phase 1 and 15 months for phase 2.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1378535|NCT01471379|Secondary|Treatment Efficacy Questionnaire (TEQ)|Treatment Efficacy Questionnaire is a measure of treatment effectiveness. The score ranges from 1 to 48, 1 is minimum score and 48 is the maximum score. The investigators was looking to see if the Milnacipran treatment groups have a higher proportion of subjects with significant improvement in efficacy, judged as a TEQ score of >28, compared to placebo group.|Twelve Weeks|Only one subject was enrolled and was analyzed even though subject did not complete the study.|||percentage of subject with score >28|||Number
1378521|NCT01471782|Secondary|Relapse-free Survival|"Relapse-free survival (RFS) was assessed for participants who achieved a complete remission during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.~Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission|||months||95% Confidence Interval|Median
1378522|NCT01471782|Secondary|Overall Survival|"Overall survival (OS) was measured for all participants from the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive. For patients who withdrew their informed consent only information until the date of withdrawal was analyzed.~Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.6 months for phase 2.|Full analysis set|||months||95% Confidence Interval|Median
1378523|NCT01471782|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured only for participants in remission and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.~Hematological relapse is defined as the proportion of blasts in bone marrow > 25% following documented remission, or extramedullary relapse.~Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission|||months||95% Confidence Interval|Median
1378524|NCT01471782|Secondary|Steady State Concentration of Blinatumomab|"Blinatumomab serum concentrations were quantified in all patients during the first 2 treatment cycles in the phase 1 part of the study only. Blinatumomab concentrations were quantified using a validated bioassay, the lower limit of quantification was 50 pg/mL. Steady state serum concentration (Css) was presumed on day 1, approximately 5 half-lives after the start of the IV infusion.~The steady state serum concentration reported is the mean of the observed concentrations collected after during cycles 1 and 2."|Cycles 1 and 2 during the IV infusion on day 3 (at least 48 hours after start of infusion) and days 8, 15 and 22 (steady state) and day 29 at End of Infusion (EoI) and 2, 4, and 8 hours after EoI for ages ≥ 2 years.|Phase 1 participants with available blinatumomab concentration data|||pg/mL||Standard Deviation|Mean
1378525|NCT01471782|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of adverse events (AEs) was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03 and according to the following:~Grade 1 - Mild adverse event; Grade 2 – Moderate adverse event; Grade 3 – Severe and undesirable adverse event; Grade 4 - Life-threatening or disabling adverse event; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days|Full analysis set|||participants|||Number
1378526|NCT01471782|Primary|Percentage of Participants With Complete Remission in the First Two Cycles|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central laboratory. Complete remission (CR) was defined as~M1 bone marrow (bone marrow blasts < 5%)~No evidence of circulating blasts or extra-medullary disease~Complete remission includes participants with incomplete recovery of peripheral blood counts."|Cycles 1 and 2 (12 weeks)|The full analysis set includes all participants who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
1378527|NCT01471782|Primary|Phase I: Number of Participants With Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) was defined as one or fewer out of 6 participants experiencing a dose limiting toxicity (DLT) or the maximum administered dose (MAD).~A dose limiting toxicity is any Grade ≥ 3 adverse event related to study drug, Grade 3 fatigue, headache, insomnia, fever, hypotension or infection were not considered dose limiting toxicities. Laboratory parameters of Grade ≥ 3 but not considered as clinically relevant and/or responding to routine medical management, thrombocytopenia, leukopenia (including neutropenia and lymphopenia), and anemia were not considered dose limiting toxicities."|Cycle 1, 28 days|Participants in the Phase 1 dose evaluation/escalation part of the study|||participants|||Number
1378528|NCT01471691|Secondary|Total Number of Ranibizumab Injections||month 12|||||||
1378529|NCT01471691|Secondary|Excess Foveal Thickness||Month 6 and 12|||||||
1378530|NCT01471691|Secondary|Percentage of Patients With CFT Less Than 300um||Month 6 and 12|||||||
1378531|NCT01471691|Secondary|Change in Mean Best Corrected Visual Acuity From Baseline||months 1-12|||||||
1378532|NCT01471691|Secondary|Mean Change From Baseline in Center Point Thickness||months 1-12|||||||
1378533|NCT01471691|Primary|Mean Change From Baseline BCVA|Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.|Baseline to month 6||||Letters (ETDRS chart)||Standard Deviation|Mean
1378534|NCT01471379|Secondary|Dose Related Incremental Benefit in Pain Reduction Based on VAS|The investigator was looking to see if, for group A, when increased from 50 mg BID to 100 mg BID there is significant improvement of pain scores i.e. 30% pain reduction, and for group C, if there was significant improvement of pain scores when switched from placebo to 50 mg BID of Milnacipran|12 Weeks||||percentage of participants|||Number
1378536|NCT01471379|Secondary|Subject Self Reported Adequate Relief of Pain|The study sought to determine if the Milnacipran arms had a greater proportion of adequate relief over the placebo group. Subjects were asked to answer ‘yes’ or ‘no’ as to whether or not they had adequate relief of pain due to irritable bowel syndrome.|Twelve Weeks||||percentage of participants|||Number
1378537|NCT01471379|Secondary|Quality of Life ( IBS-QOL)|After six weeks of treatment with Milnacipran, treatment groups were compared with placebo for clinically significant improvement in IBS-QOL. 11 point reduction in IBS-QOL compared to baseline was considered as clinically significant improvement.|Six Weeks|||||||
1378538|NCT01471379|Primary|Number of Participants With Pain Response|Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain before the beginning of the study, at 6 weeks of treatment and at the end visit i.e. 10 weeks. Ideally, VAS would have been administered at the 12th week; however, subject was terminated at the 10th week visit. A positive pain response (ie pain relief) was defined as >30% decrease in the VAS score between baseline and the final study visit.|Twelve Weeks||||participants|||Number
1378539|NCT01471353|Secondary|Correlative Tissue Analysis|Exploratory tissue analysis in patients receiving sorafenib plus capecitabine|6 months||2018-12-31|12/2018||||
1378540|NCT01471353|Secondary|Toxicity|Evaluate acute toxicity of treatment. The toxicity assessments were graded by the NCI CTCAE (Clinical Trial Common Adverse Event) grading system – a global standard for assessments of clinical and laboratory toxicities. All toxicities are scored 1(mild) through 5 (death related to the event) based upon well-defined and reproducible definitions.|12 months||||percentage of participants|||Number
1378541|NCT01471353|Secondary|Time to Progression|Time to disease progression while on and/or after treatment complete|up to 12 months||2018-12-31|12/2018||||
1378542|NCT01471353|Secondary|Response Rate|Measure response rate to treatment|3 months||2018-12-31|12/2018||||
1378543|NCT01471353|Secondary|Overall Survival|Evaluate overall survival after treatment.|5 years||||days||95% Confidence Interval|Median
1378544|NCT01471353|Primary|Sorafenib Activity|Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years||||days||95% Confidence Interval|Median
1378545|NCT01471340|Other Pre-specified|Number of SAO Components in MF/F Participants vs MF Participants|To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only.|26 weeks, or 7 days after the last treatment dose, whichever occurred later|The analyzed population for tabulation of the number of SAO components was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).|||SAO components|||Number
1378546|NCT01471340|Secondary|Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms|The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant.|26 weeks, plus 7 days after the last treatment|The analyzed population for assessment of the number of first asthma exacerbations was all treated participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).|||Asthma exacerbations|||Number
1378547|NCT01471340|Primary|Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms|The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.|26 weeks, or 7 days after the last treatment dose, whichever occurred later|The analyzed population for assessment of the number of first SAO was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).|||Serious asthma outcomes|||Number
1378548|NCT01471639|Secondary|Adverse Event/Side Effects|Safety assessed by reporting of all adverse events and side effects.|Up to 4 hours|Participants who reported discomfort or unpleasant feeling associated with use of intranasal ketorolac|||Participants|||Count of Participants
1378549|NCT01471639|Primary|Efficacy of Intranasal Ketorolac on Numeric Pain Scale|Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)|up to 4 hours|Improvement in pain score rating among participants rating from baseline pain scores, 20 minutes, 40 minutes, 1 hour, 2 hour, 3 hour and 4 hour post dose. Pain scale ranging from 0 (no pain) - 10 (worst possible pain)|||Participants|||Count of Participants
1378550|NCT01471626|Primary|Quality of Polysomnographic Recordings|Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.|1 week||||percentage of recording failure|||Number
1378551|NCT01471574|Secondary|Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation|Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy.|From Day 1 to 7 days post last dose of study treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study drug.|||Participants|||Number
1378552|NCT01471574|Secondary|Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Percentages calculated as number of responders/number who received treatment.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy. Here 'n' signifies number of participants evaluable at the specified time-point.|||Percentage of participants||95% Confidence Interval|Number
1378553|NCT01471574|Secondary|Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL|Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.|End of treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study therapy|||Percentage of participants||95% Confidence Interval|Number
1378554|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.|||Percentage of participants|||Number
1378555|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.|||Percentage of participants|||Number
1378556|NCT01471574|Primary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy.|||Percentage of participants||95% Confidence Interval|Number
1378557|NCT01471197|Secondary|Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study.|Day 1 to Date of last patient, last visit, approximately 7 months after study started.|All participants who received at least one dose of study drug.|||participants|||Number
1378558|NCT01471197|Secondary|Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants|Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose.|Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.|All participants who were randomized and treated with at least one dose of either study drug.|||participants|||Number
1378559|NCT01471197|Primary|Overall Survival of Participants During the Study - All Treated Participants|Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.|Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started|All participants who received at least one dose of either study drug.|||participants|||Number
1378574|NCT01470651|Primary|Adherence to Medications Form|The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil.|HCV medication adherence reported at 12 weeks|Not all patients were given all medications, subjects are not factored in if they were not told to take a given drug.|||Percentage of doses missed||Standard Error|Mean
1378560|NCT01471171|Secondary|Change From Baseline in Intensity of Dyspnoea|Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.|||Units on a scale||Standard Error|Least Squares Mean
1378561|NCT01471171|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)|Change from baseline in trough IC after 3 weeks of treatment|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.|||Litres||Standard Error|Least Squares Mean
1378562|NCT01471171|Primary|Change From Baseline in Endurance Time (Seconds)|Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.|||Seconds||Standard Error|Least Squares Mean
1378563|NCT01471041|Secondary|Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide|Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide|6 months||||participants|||Number
1378564|NCT01471041|Primary|Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis|Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.|3 months||||participants|||Number
1378565|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the Second Dose.|"The pharmacokinetic profile of Darbe will be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. A second dose of Darbe will be given at 7 days of age, and serum drug levels will be obtained at 12, 18, 24, and 36 hours post second dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 36 hours after second dose||||AUC (h*mU/L)||Inter-Quartile Range|Median
1378566|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the First Dose During Cooling|"The pharmacokinetic profile of Darbe wil be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. Serum levels will be drawn at 4,12, 18, 24, 36, 60, and 72 hours post initial dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 72 hours after first dose||||AUC (h*mU/L)||Inter-Quartile Range|Median
1378567|NCT01471015|Secondary|Number of Participants With Adverse Events.|"Potential adverse events such as (but not limited to) alterations in blood pressure, secondary infections, neutropenia, thrombotic/vascular events, hematologic events (platelets, Hct level, polycythemia), and hepatic/renal function that are outside of normal range for the study population.~Complications associated with HIE or cooling therapy will not be considered an AE for this study. AEs reported to be associated with cooling include: bleeding/thrombosis, persistent pulmonary hypertension of the newborn (PPHN), skin changes, arrhythmia, and persistent acidosis."|30 days or until hospital discharge||||participants|||Number
1378568|NCT01470859|Secondary|Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).|"Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved.~The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)"|twice, at 10 weeks(V2) and 1 year(V5)||||participants|||Number
1378569|NCT01470859|Secondary|Hoehn&Yahr (H&Y) Staging|"The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe.~The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5)."|twice baseline and 1 year||||units on a scale||Standard Deviation|Mean
1378570|NCT01470859|Secondary|Parkinson's Disease Questionnaire (PDQ39)|"The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).~PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe."|twice baseline and 1 year||||units on a scale||Standard Deviation|Mean
1378571|NCT01470859|Secondary|Unified Parkinson's Disease Rating Score (UPDRS II, III)|baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.|three times: baseline, 10 weeks, 1 year||||units on a scale||Standard Deviation|Mean
1378572|NCT01470859|Primary|Longitudinal Change of Brain Network Activity|"The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).~The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1."|twice, baseline and 1 year after baseline||||Z-score in PDRP||Standard Deviation|Mean
1378573|NCT01470651|Secondary|Fatigue Severity Scale (FSS)|Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. “fatigue interferes with my work, family or social life”). Response format is a 7-point Likert scale of agreement with a 1-week time frame. Total score is the sum of item scores and ranges from 9 to 63 points, with higher scores indicating greater fatigue. A score greater than 40 is considered to be a clinically significant level of fatigue. Scores on the scale correlate highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil.|Biweekly for the first month, monthly thereafter||||FSS score (out of 63)||Standard Deviation|Mean
1378575|NCT01470599|Secondary|Length of Hospitalizations Due to Crohn’s Disease|The length of hospitalizations due to Crohn's disease were recorded at every study visit.|From baseline to Week 52/follow-up|SAS|||Percentage of participnats|||Number
1378576|NCT01470599|Primary|Adjudicated Interstitial Lung Disease (ILD) Events|Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs||||||
1378577|NCT01470599|Primary|Adjudicated Gastrointestinal (GI) Perforation Events|Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
1378578|NCT01470599|Primary|Adjudicated Opportunistic Infection Events|Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
1378579|NCT01470599|Primary|Adjudicated Hepatic Injury Events|Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy’s law case, recovery & liver failure (all yes, no or undetermined).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
1378580|NCT01470599|Secondary|Percentage of Participants Hospitalized Due to Crohn’s Disease|The number of participants hospitalized due to Crohn's disease were recorded at every study visit.|From baseline to Week 52/follow-up|SAS|||Percentage of participants|||Number
1378581|NCT01470599|Secondary|Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit|EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 48/ET visit|Participants in the FAS who had non-missing data at Week 48/ET visit|||mm||Standard Deviation|Mean
1378582|NCT01470599|Secondary|EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit|EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS|||mm||Standard Deviation|Mean
1378583|NCT01470599|Secondary|Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit|"EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state."|Baseline and Week 48/ET visit|Participants in the FAS who had non-missing data at Week 48/ET visit|||Score on a scale||Standard Deviation|Mean
1378584|NCT01470599|Secondary|EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit|"EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data."|Baseline and Week 48/ET visit|FAS|||Score on a scale||Standard Deviation|Mean
1378585|NCT01470599|Secondary|Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit|The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS|||Score on a scale||Standard Deviation|Mean
1378661|NCT01469767|Secondary|BSA|Body Surface Area of atopic dermatitis. The BSA is measured as the total percent of the entire body with atopic dermatitis involved, so the scores range from 0% to 100% of total body involvement.|14 days||||Percent BSA||Full Range|Mean
1378586|NCT01470599|Secondary|Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit|The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS|||Score on a scale||Standard Deviation|Mean
1378587|NCT01470599|Secondary|Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category|The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.|Week 48/ET visit|Participants in the FAS who had a response to PRTI assessment at Week 48/ET visit|||Percentage of participants|||Number
1378588|NCT01470599|Secondary|Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. A score ≥170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.|Week 48/ET|Participants in the FAS who had non-missing data at Week 48/ET visit|||Percentage of participants||95% Confidence Interval|Number
1378589|NCT01470599|Secondary|Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL.|Baseline and Week 48/ET|Participants in the FAS who had non-missing data at Week 48/ET visit|||Score on a scale||Standard Deviation|Mean
1378590|NCT01470599|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit|The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.|Baseline and Week 48/early termination (ET)|FAS|||Score on a scale||Standard Deviation|Mean
1378591|NCT01470599|Secondary|Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||mg per liter (mg/L)||Standard Deviation|Mean
1378592|NCT01470599|Secondary|Observed Change From Baseline in Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||mg per kilogram (mg/kg)||Standard Deviation|Mean
1378593|NCT01470599|Secondary|Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit|There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks. Percentage of participants whose study treatment were switched from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after initial assignment was reported.|From baseline to Week 48|FAS|||Percentage of participants|||Number
1378594|NCT01470599|Secondary|Corticosteroid Use Over Time|Use of corticosteroids (yes or no) was recorded at baseline and throughout the study. Percentage of participants taking corticosteriod at each visit was reported.|Weeks 8, 16, 24, 36 and 48|SAS|||Percentage of participants|||Number
1378595|NCT01470599|Secondary|Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline|Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Week 48|Participants in FAS who were on steroids at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
1378836|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)|All occurrences of participants who received at least 1 infusion of tocilizumab and then stopped tocilizumab infusions due to an AE or SAE were analyzed.|Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24|SAS Population|||Percentage of Participants|||Number
1378596|NCT01470599|Secondary|Change From Baseline Observed CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.|Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||Score on a scale||Standard Deviation|Mean
1378597|NCT01470599|Secondary|Observed CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||Score on a scale||Standard Deviation|Mean
1378598|NCT01470599|Secondary|Time to Relapse Among Participants in Clinical Remission at Baseline|"Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves.~n = number of participants remaining at risk."|From baseline to Week 52|Participants in the FAS who met clinical remission criteria at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
1378599|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|Participants in the FAS who met clinical response or clinical remission criteria at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
1378600|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|Participants in the FAS who met clinical remission criteria at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
1378601|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of less than (<) 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Week 48|Full analysis set (FAS) - consisted of all participants enrolled in this OL extension study.|||Percent||95% Confidence Interval|Number
1378602|NCT01470599|Primary|Adjudicated Malignancy Events|Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
1378603|NCT01470599|Primary|Adjudicated Potential Cardiovascular Events|Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium ‘Standardized Definitions for End Point Events in Cardiovascular Trials’ published October 2010.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
1378604|NCT01470469|Primary|Change From Baseline in ECG QTcF Interval at up to 12 Weeks|The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||Standard Deviation|Mean
1378605|NCT01470469|Primary|Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks|QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||Standard Deviation|Mean
1378606|NCT01470469|Primary|Change From Baseline in Weight at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||kg||Standard Deviation|Mean
1378607|NCT01470469|Primary|Change From Baseline in Height at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||cm||Standard Deviation|Mean
1378608|NCT01470469|Primary|Change From Baseline in Pulse Rate at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
1378609|NCT01470469|Primary|Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1378610|NCT01470469|Primary|Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1378611|NCT01470417|Secondary|Prognostic Risk Stratifiers|Evaluate key biochemical, radiographic, and pathologic factors that may impact response to neoadjuvant therapy|5 years|||||||
1378612|NCT01470417|Secondary|Quality of Life Analysis|Evaluate quality of life as related to treatment and toxicity.|2 years|||||||
1378613|NCT01470417|Secondary|Treatment Associated Toxicity|Evaluate treatment related acute and long-term toxicity|5 years|||||||
1378614|NCT01470417|Secondary|90 Day Post-operative Mortality|Evaluate mortality in the first 90 days after surgery|90 days after surgery||||participants|||Number
1378615|NCT01470417|Secondary|Overall Survival|Survival status 5 years after treatment|5 years after treatment|||||||
1378616|NCT01470417|Secondary|Disease Free Survival|Length of disease free survival after treatment|5 years|||||||
1378617|NCT01470417|Primary|Pathologic Downstaging and Margin Status|Pathologic stage and margin status after resection. Pathologic downstaging was determined my looking at the rate of R0 (all residual tumor removed during surgery) vs R1 (microscopic tumor present at the resection margin per pathology) resections.|At the time of surgery after neoadjuvant therapy|Subjects who had a surgical resection of their primary tumor were included in this analysis.|||participants|||Number
1378618|NCT01470417|Primary|Radiographic Response Rate|Evaluate radiographic response of the measurable disease with repeat imaging at 4 - 8 weeks after therapy. Measurable disease was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. Per RECIST v1.1 in target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >20% growth in the sum of the longest diameter or target lesions or appearance of new lesions; Stable Disease (SD), change in sum of longest diameter of target lesions does not meet criteria for PR or PD. The number of subjects experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) is reported.|4 - 8 weeks after neoadjuvant therapy|All subjects enrolled in the study were included in this analysis.|||participants|||Number
1378619|NCT01470417|Primary|Biochemical Response Rate|Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values.|4 - 8 weeks after neoadjuvant therapy|The seven subjects included in this analysis had CA19-9 testing performed at baseline and again prior to surgery. Pre-operative CA19-9 testing was not performed for one subject so they were not included in this analysis nor were two subjects who were found to have progressive disease prior to completing neoadjuvant therapy.|||U/mL||Full Range|Mean
1378620|NCT01470248|Secondary|Overall Survival|Duration of time from enrollment on study until death|From enrolment till death on average up to 2 years|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.|||months||Full Range|Median
1378621|NCT01470248|Secondary|Progression-free Survival|"Defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|Every 8 weeks|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.|||weeks||Standard Deviation|Mean
1378622|NCT01470248|Primary|Clinical Benefit Rate (CBR)|Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis.|After completing at least 1 cycle (8 weeks) of treatment|An alternative endpoint of clinical benefit rate was pre-specified in the event that the study failed to meet its overall response rate (ORR) endpoint either at the end of stage I accrual or at final analysis. However, this study met its endpoint. Please see primary outcome measure 1.||||||
1383988|NCT01422070|Secondary|Length of ICU Stay|Number of days (calendar days -1) from admission to and discharge from the Study Unit|Max 90 days after admission to intensive care unit||||days||Inter-Quartile Range|Median
1378623|NCT01470248|Primary|Response Rate (RR)|"Response rate (complete response [CR]+ partial response [PR]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).~Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 8 weeks|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.|||Participants|||Count of Participants
1378624|NCT01470196|Primary|Very Good Partial Response and Complete Response Rate|This is the rate of VGPR and CR in patients on CaRD therapy. Very good partial responses are >90% reduction in serum IgM from baseline. Complete response is defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.|4 years||||Participants|||Count of Participants
1378625|NCT01470196|Primary|Major Response Rate|Major Response Rate= Partial Response (>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).|4 years||||Participants|||Count of Participants
1378626|NCT01470196|Primary|Time to Progression|Progression-free survival is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum IgM and 500mg/dL absolute increase from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).|4 years||||months||95% Confidence Interval|Median
1378627|NCT01470196|Primary|Neuropathy Incidence Rate|Number and percentage of participants who experienced neuropathy attributable to CaRD therapy|3 years||||Participants|||Count of Participants
1378628|NCT01470196|Primary|Overall Response Rate|Overall Response Rate= Minor response (>25%-50% reduction in serum IgM from baseline + Partial Response (>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).|4 years||||Participants|||Count of Participants
1378629|NCT01470170|Secondary|Hypotension|Check the frequency of hypotension episode during induction, procedure and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||participants|||Number
1378630|NCT01470170|Secondary|Hypoxemia|Check the frequency of hypoxemia episode during induction, procedure, and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||participants|||Number
1378631|NCT01470170|Primary|Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3|After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||second||Standard Deviation|Mean
1378632|NCT01470170|Primary|Propofol Dose Needed to Reach Conscious Level OAAS-3|After the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||mg||Standard Deviation|Mean
1378633|NCT01470170|Primary|Effect Site Concentration When Conscious Level Reaches OAAS-3|After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||ug/ml||Standard Deviation|Mean
1378634|NCT01470144|Secondary|Exposure Duration|Duration of exposure to EFI|On average 2.72 years||||year||Full Range|Median
1378635|NCT01470144|Primary|Treatment-emergent Adverse Events||On average 2.72 years|All patients who received at least one dose of EFI|||Number of patients|||Number
1378636|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378637|NCT01470118|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378638|NCT01470118|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378639|NCT01470118|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378640|NCT01470118|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378641|NCT01470118|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378642|NCT01470118|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378643|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 0 Hour 16|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
1378644|NCT01470027|Secondary|Parkinson's Disease Quality of Life Questionnaire (PDQLQ)|"The Parkinson's Disease Quality of Life Questionnaire is a self completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson’s disease.~The Parkinson's Disease Quality of Life Questionnaire is coded on a scale of 0 to 185, with 185 indicating perfect health and 0 indicating very poor health."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for PDQLQ because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment PDQLQ scores were available only for 43 subjects, whose data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1378645|NCT01470027|Secondary|Beck Anxiety Inventory|"The Beck Anxiety Inventory (BAI) is a clinician-administered and validated instrument to discriminate anxiety from depression. The standardized BAI cutoffs are:~0–9: minimal anxiety; 10–16: mild anxiety; 17–29: moderate anxiety; 30–63: severe anxiety."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for Beck Anxiety Inventory (BAI) test because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment BAI scores were available only for 45 subjects, whose data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1378646|NCT01470027|Secondary|10-Meter Walk Test|"The 10-meter walk test is a standardized, quantitative timed test of lower body motor function. The maximal gait speed is measured during a 10-meter walk. The task will be performed three times and the average time to complete the task once will be recorded. The 10-meter walk test is a reliable and sensitive measure of gait function in elderly individuals and PD patients.~Cut-off values:~< 0.4 m/s more likely to be household ambulators; 0.4 - 0.8 m/s limited community ambulators; > 0.8 m/s community ambulators."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for 10-Meter Walk Test because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment 10-Meter Walk Test score were available only for 46 subjects, whose data were included in the analysis.|||m/s (meters per second)||Standard Deviation|Mean
1378647|NCT01470027|Secondary|9-Hole Peg Board Test (9-HPT)|The 9-HPT is a standardized, quantitative timed test of upper extremity motor function. Individuals are asked to place and remove nine pegs, one at a time, from nine holes in a board as quickly as possible. The task is performed twice with the dominant and twice with the non-dominant hand, and the average time to complete the task once is calculated for each hand. The 9-HPT has a high inter- and intra-rater reliability, is validated and is sensitive to detect minor impairments of hand function.|at baseline and 4 weeks after intervention start|The measurement used for the 9-HPT is the average of time needed to complete the task with the dominant and non-dominant hand recorded in seconds. The presence of PD is expected to produce higher test times in seconds.|||s (in seconds)||Standard Deviation|Mean
1378648|NCT01470027|Secondary|Hamilton Depression Rating Scale (HAM-D)|"The Hamilton Depression Rating Scale (HAM-D) is a 21-item instrument designed to measure the severity of illness in adults already diagnosed as having depression. The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient’s level of depression before, during, and after treatment. It is clinician-administered and requires 15 to 20 minutes complete the interview and score the results. Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.~The minimum score is 0 and maximum score is 50. The scale has been widely used in clinical practice and become a standard in pharmaceutical trials.~HAM-D Scoring Instructions are following:~0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression;~≥ 23 = Very Severe Depression."|at baseline and 4 weeks after intervention start||||units on a scale||Standard Deviation|Mean
1378649|NCT01470027|Secondary|Mini Mental State Examination (MMSE)|The MMSE is a brief questionnaire-based test that is used to screen for cognitive impairment. Domains tested are orientation to time and place, registration, attention and calculation, recall, language, repetition and complex commands. Scores lower than 25/30 points indicate mild (21-24 points), moderate (10-20 points) or severe (<10 points) cognitive impairment, but scores may need to be corrected for educational attainment, age and interfering impairments such as motor deficits that affect drawing skills.|at baseline and 4 weeks after intervention start||||units on a scale||Standard Deviation|Mean
1378650|NCT01470027|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)|"The UPDRS is considered the gold standard for determining disease severity and progression in patients with Parkinson’s disease. It consists of the following five elements:~Evaluation of mentation, behavior and mood.~Self evaluation of the activities of daily living (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, etc.~Motor evaluation by a clinician.~Hoehn and Yahr scale (Hoehn 1967) for the description of the overall disease severity in PD with 8 stages.~Schwab and England activities of daily living scale (Schwab and England 1969) for the estimation of the general abilities in PD patients. The Schwab and England ADL scale is graduated in 10% steps with 100% indicating complete independence and 0% indicating an individual in whom the vegetative functions are completely impaired.~A total of 199 points are possible for UPDRS, with 199 representing the worst disability and 0 no disability."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for Unified Parkinson's Disease Rating Scale (UPDRS) because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment UPDRS were available only for 40 subjects, whose data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1378651|NCT01470027|Primary|Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy|"In vivo brain GSH measured with 1H MRS in the unmedicated patients with idiopathic PD and in sex- and age-matched healthy controls prior to and following 4 weeks supplementation with either placebo, 1800mg/day or 3600 mg/day of NAC. Striatal and occipital cortex glutathione levels as measured in vivo by 1H MRS at baseline and following 4 weeks of treatment with placebo, 1800mg NAC/day and 3600mg NAC/day.~The area under the GSH spectral peak was obtained by frequency-domain fitting of the GSH resonance in the edited spectrum to a pseudo-Voigt lineshape function using a robust and highly optimized public-domain Levenberg–Marquardt nonlinear least-squares minimization routine. The resulting peak areas were then expressed as ratios relative to the synchronously acquired and similarly fitted unsuppressed voxel water signal."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for brain GSH levels because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment GSH values were available only for 43 subjects, whose data were included in the analysis.|||Ratio||Standard Deviation|Mean
1378652|NCT01470001|Secondary|Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)|"The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect.~The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease)."|outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment|one subject was excluded from analysis because of missing baseline data|||change in score||Full Range|Mean
1378653|NCT01470001|Secondary|the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes||outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12|one study subject was excluded form analysis due to missing baseline data|||percent|||Number
1378654|NCT01470001|Primary|The Percent Reduction in Post Void Dribbling Episodes (Events)||outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12|one subject was excluded from analysis because of missing baseline data|||percent reduction||Full Range|Mean
1378655|NCT01469819|Secondary|Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.||Measured at baseline and 2 weeks after baseline.||||participants|||Number
1378656|NCT01469819|Secondary|Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day.||Measured at baseline and 2 weeks after baseline.|Number of Bowel Movements per week|||number per week||Standard Error|Mean
1378657|NCT01469819|Secondary|Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.|Changes in Time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week.|Measured at baseline and 2 weeks after baseline.||||Hours||Standard Error|Mean
1378658|NCT01469819|Secondary|Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).||Measured at baseline and 2 weeks after baseline||||number per week||Standard Error|Mean
1378659|NCT01469819|Primary|Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day.|The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.|Measured at baseline and 2 weeks after baseline.||||Hours||Standard Error|Mean
1378660|NCT01469767|Secondary|VAS|Visual Analog Scale for itch: A 100 millimeter (mm) Visual Analog Scale (VAS) will be used to measure itch intensity. VAS is a self-report tool that is designed to present to the respondent a rating scale with minimum constraints. VAS data is recorded as the number of mm from the left of the line with the range 0-100 mm. The Visual Analog Scale is anchored with the verbal descriptions of “no itch” on the left and “the most intense itch imaginable” on the right.|14 days||||units on a scale||Full Range|Mean
1378662|NCT01469767|Secondary|EASI|"Eczema Area and Severity Index Score:Disease severity will be assessed with the Eczema Area and Severity Index (EASI).This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions and scores erythema, excoriation, induration/papulation, and lichenification. The total are summed for one total EASI score. .The total scores range from 0 (no Eczema) -72 (most severe Eczema)."|14 days||||units on a scale||Full Range|Mean
1378663|NCT01469767|Secondary|Actigraphy|Actigraphy Movement Count per Hour:Subjects will be asked to wear an actigraphy monitor on each wrist for the duration of the 14-day study. These monitors appear and function similarly to a wristwatch. The actigraph provides a continuous measure of wrist activity and may be used to quantify nocturnal scratching behavior. A piezoelectric accelerometer records the integration of intensity, amount, and duration of stimuli in all 3 dimensions of wrist movement. Measurements are taken at 32 Hz and a summation value is recorded at the end of each 30-second epoch. The number of 30-second epochs with movement (in which acceleration was detected irrespective of the magnitude of the acceleration) is recorded and summed to give a movement score. This is divided by the duration of time in bed to produce a movement count per hour, which is a sensitive quantitative measure of scratch-associated activity.|14 days||||Movement count per hour||Standard Deviation|Mean
1378664|NCT01469767|Primary|IGA|Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from ‘0’ = Clear to ‘5’ = Very Severe Disease|14 days||||units on a scale||Full Range|Mean
1378665|NCT01469715|Primary|Absolute Relative Difference (ARD)|"ARD=100*(G_sensor-G_reference)/G_reference~Calculated for when patient's G_ref was Normal (70-180 mg/dl), Hyperglycemic (>180 mg/dl) and Hypoglycemic (<70 mg/dl)~The study data includes 208 paired sensor-YSI plasma glucose readings (G_reference) for each GBP CGM sensor (G_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as median and mean absolute deviations and median and mean absolute relative deviation and Point CG-EGA, as well as dynamic parameters, such as warm-up time, trend accuracy (Rate CG-EGA), and sensor lag."|25.5 hours||||percentage of error|||Number
1378666|NCT01469637|Primary|Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ug/ml||Standard Deviation|Mean
1378667|NCT01469637|Primary|Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||h*ug/ml||Standard Deviation|Mean
1378668|NCT01469546|Secondary|Median Progression-Free Survival (PFS)Time|To evaluate PFS time in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.|||months||95% Confidence Interval|Number
1378669|NCT01469546|Secondary|Number of Patients That Experienced Grade 3 or 4 Toxicities|The number of patients who develop these while on treatment and for 28 days after cessation of axitinib, and graded in severity per CTCAE v. 3.0 and as described in the protocol. According to the CTCAE v. 3.0, grade 3 toxicities are severe and grade 4 toxicities are life-threatening or disabling.|28 Days Post Treatment|All patients that received at least one dose of treatment were analyzed for toxicity.|||patients|||Number
1378670|NCT01469546|Secondary|Number of Participants Who Achieved Complete Response, Partial Response or Stable Disease|"To determine the disease control rate (complete response+partial response+stable disease), in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.~Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) will be used.~Complete Response is defined as the disappearance of all tumor for a period of one month.~Partial Response is defined as a 30% or more decrease in the sum of the longest diameters (LD) of all measured lesions without any evidence of progression of any lesion or the appearance of any new lesion for a period of one month.~Stable Disease is defined as any change in measurable disease which is less than the criteria for partial remission or progression without any evidence of new lesions and persisting for at least 2 evaluations or 2 months."|2 years|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.|||participants|||Number
1378671|NCT01469546|Primary|Percentage of Patients Alive and Free of Progression at 6 Months|To determine the 6-months progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.|||percentage of patients|||Number
1378701|NCT01469182|Secondary|Number of Participants Reporting Throat Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378702|NCT01469182|Secondary|Number of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378672|NCT01469377|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8|The SDS measures an individual’s perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat population consisted of all patients in the Safety Population who had at least 1 post-baseline assessment of the MADRS total score. Only participants with scores for all 3 domains were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1378673|NCT01469377|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat population consisted of all patients in the Safety Population who had at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
1378674|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|Within-subject change to absolute FEF 25-75 month 1 vs. 0. FEF 25-75 was measured 14-35 days after the start of months 1|Baseline, month 1||||Liter||Inter-Quartile Range|Median
1378675|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|Within-subject change to absolute FEF 25-75 month 5 vs 0. FEF 25-75 was measured 14-35 days after the start of months 5|Baseline, month 5||||Liter||Inter-Quartile Range|Median
1378676|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 5 vs 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in theTotal Score. The SGRQ was completed 14-35 days after the start of month 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.|||units on a scale||Inter-Quartile Range|Median
1378677|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 1 vs. 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in the Total Score. The SGRQ was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28) time-points.|||units on a scale||Inter-Quartile Range|Median
1378678|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5.|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 5 vs 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 and 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.|||units on a scale||Inter-Quartile Range|Median
1378679|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 1 vs. 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28)|||units on a scale||Inter-Quartile Range|Median
1378680|NCT01469364|Secondary|Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC).|The study team is measuring the change in neutrophils AFTER treatment. They will compare a SOC BAL taken after AZLI with the BAL taken within 90 days of AZLI initiation (pre or baseline measure). The post AZLI BAL measurement time range is 15 days after first course of AZLI up to last day of the 3rd and final course of AZLI (over a period of 5 consecutive months).|Baseline - defined as a within 90 days of enrollment and After Treatment (5 months)|Participants with paired SOC bronchoalveolar lavage fluid cell differential counts performed within 90 days of AZLI month 1 (baseline timepoint) and >=15 days after AZLI dose 1 through the completion of dose 3 (study month 5) were included in the analysis (n=5).|||mean percentage of neutrophils||Standard Deviation|Mean
1378681|NCT01469364|Secondary|Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid.|Microbiology data was collected when performed for SOC purposes on BAL or sputum samples. Baseline and 1 month value represents the culture final report value (0,1+, 2+, 3+, 4+) of Pseudomonas aeruginosa. A value of zero represents no Pseudomonas aeruginosa sputum or bronchoalveolar fluid. A value of 4 represents high amounts of Pseudomonas aeruginosa sputum or bronchoalveolar fluid.|Baseline, month 1|The statistical analysis was unable to be performed due to insufficient number of paired observations. Only 9 of 30 enrolled had baseline microbiology data, 3 were cultured positive for Pseudomonas Aeruginosa. Only 1 of the 3 had a subsequent SOC BAL sample collected. Therefore, only raw data is entered for the one subject.|||culture value of Pseudomonas aeruginosa|||Number
1378682|NCT01469364|Secondary|Change in HRQOL Off AZLI Therapy.|This will be compared to study month 0 (baseline), when obtained at standard of care visit (SOC)|At study months 2 or 4|Partial data for this outcome measure was collected on 4 participants and due to not having a complete data set the analyzation was not completed.||||||
1378683|NCT01469364|Secondary|Change in FEV1 Off AZLI Therapy|This will be compared to study month 0 (baseline, when obtained as standard of care (SOC).|At Study Months 2 and 4|Partial data for this outcome measure was collected on 4 participants and due to not having complete data set analyzation was not completed.||||||
1378684|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 5 vs 0.|Baseline, month 5||||Liter||Inter-Quartile Range|Median
1378685|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 1 vs. 0. FEV1 was measured 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1||||Liter||Inter-Quartile Range|Median
1378686|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378687|NCT01469234|Secondary|Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point|"The individual symptom score for Nasal Congestion was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378688|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Eyes was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378689|NCT01469234|Secondary|Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Water Eyes was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378703|NCT01469182|Secondary|Number of Participants Reporting Oral Pruritus.|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378768|NCT01468896|Secondary|Number of Confirmed Clinical Responses (Phase I)|Summarized by simple descriptive summary statistics. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months||||Participants|||Count of Participants
1378690|NCT01469234|Secondary|Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point|"The individual symptom score for Sneezing was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378691|NCT01469234|Secondary|Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Nose was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378692|NCT01469234|Secondary|Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Runny Nose was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378693|NCT01469234|Primary|Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)|The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
1378694|NCT01469221|Secondary|2-Year Recurrence Rate|Proportion of patients with recurrence at or before 24 months|24 Months|Patients who were in the Double Blind Phase|||Participants|||Count of Participants
1378695|NCT01469221|Primary|Time to Recurrence|Time from randomization to the date of first histologically confirmed recurrence of bladder cancer|24 Months|Patients who were in the Double Blind Phase|||months||Full Range|Median
1378696|NCT01469182|Secondary|Number of Participants Who Discontinued Due to Treatment-emergent AEs|Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 28|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378697|NCT01469182|Secondary|Number of Participants Reporting Skin Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378698|NCT01469182|Secondary|Number of Participants Reporting Nasal Passage Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378699|NCT01469182|Secondary|Number of Participants Reporting Eye Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378700|NCT01469182|Secondary|Number of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378788|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2|||||||
1378704|NCT01469182|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 35|All subjects as treated (ASAT) consisting of participants who received at least one dose of study treatment|||Participants|||Number
1378705|NCT01469065|Secondary|Change From Baseline in Fasting Lipid Parameters at Day 14 and 16|Baseline for fasting triglycerides (TG) was defined as the average of the Day -1 (hour -48), Day 0 (hour -24), and Day 1 pre-dose (hour 0) measurements. Baseline for fasting total cholesterol (TC), cholesterol (high-density lipoprotein (HDL)), and cholesterol (low-density lipoprotein (LDL)) was defined as the Day 1 pre-dose (hour 0) measurement.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 on Day 1 for TG and Hour 0 (before morning dose) on Day 1 for TC, HDL, and LDL; 48 hours after morning dose on Day 16 for TG and Hour 0 (before morning dose) on Day14 for TC, HDL, and LDL|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."|||mg/dL||Standard Deviation|Mean
1378706|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of C-peptide from Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) was calculated based on 8 C-peptide measurements at prespecified timepoints using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||ng*hr/mL||Standard Deviation|Mean
1378707|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of Insulin from Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) was calculated based on 8 insulin measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||milliUnit*hour/liter (mU*hr/L)||Standard Deviation|Mean
1378708|NCT01469065|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The average of the Day -1 (hour -48), Day 0 (hour -24) and Day 1 pre-dose (hour 0) measurements was the baseline for fasting plasma glucose (FPG) analyses.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 (before morning dose) on Day 1; hour 0 (before morning dose of each day) on Days 1, 2, 3, 6, and 10; and 24 hours after Day 14 morning dose on Day 15|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."|||mg/dL||Standard Deviation|Mean
1378709|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area under the curve of glucose from time 2 to 6 hours post morning dose (Glucose AUC(2-6)) was calculated based on 8 glucose measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||mg*hr/dL||Standard Deviation|Mean
1378710|NCT01469065|Secondary|Change From Baseline (Day -2) in Mean Daily Glucose at Day 13|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day.|Baseline: hours -72, -70, -68, -66, -62, -60, -57, and -54 on Day -2 (Day 1 morning dose was hour 0); Day 13: 0 (before morning dose), 2, 4, 6, 10, 12, 15 and 18 hours after Day 13 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||mg/dL||Standard Deviation|Mean
1378711|NCT01469065|Secondary|Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532|Maximum Observed Plasma Concentration of PF-04991532 after Morning Dose Administration (Cmax(AM)) divided by dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng/mL/mg||Standard Deviation|Geometric Mean
1378712|NCT01469065|Secondary|Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532|Area under the curve from time zero to 24 Hours Postdose (AUC24) divided by total daily dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng*hr/mL/mg||Standard Deviation|Geometric Mean
1378789|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2|||||||
1378713|NCT01469065|Secondary|Observed Accumulation Ratio of Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Rac, Cmax(AM))|Maximum observed plasma concentration of PF-04991532 after morning dose administration (Cmax(AM)) of Day 14 divided by Cmax(AM) of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Geometric Mean
1378714|NCT01469065|Secondary|Observed Accumulation Ratio of Area Under the Curve From Time Zero to 10 Hours Postdose of PF-04991532 (Rac)|Area under the curve from time zero to 10 hours postdose of PF-04991532 (AUC10) of Day 14 divided by AUC10 of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Geometric Mean
1378715|NCT01469065|Secondary|Apparent Oral Clearance (CL/F) of PF-04991532|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 and Day 14: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10 (before evening dose), 10.5, 11, 12, 13, 15, 18 and 24 hours after morning dose|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||milliliter/minute (mL/min)||Standard Deviation|Geometric Mean
1378716|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM))|Time was computed as post morning dose.|10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||hour||Full Range|Median
1378717|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM))||0 (predose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||hour||Full Range|Median
1378718|NCT01469065|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532||Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.|||ng/mL||Standard Deviation|Geometric Mean
1378719|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))||10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng/mL||Standard Deviation|Geometric Mean
1378720|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))||0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning||||ng/mL||Standard Deviation|Geometric Mean
1378721|NCT01469065|Secondary|Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 10 hours post morning dose.|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng*hr/mL||Standard Deviation|Geometric Mean
1378722|NCT01469065|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours post morning dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1378723|NCT01469065|Primary|Change From Baseline (Day -1) in Mean Daily Glucose at Day 14|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.|Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1378724|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||hr||90% Confidence Interval|Geometric Mean
1378736|NCT01469039|Primary|The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.|Data collected from baseline to day 85|Full Analysis Set (FAS) defined as all randomized subjects who received at least 1 dose of IM study drug and had at least 1 primary efficacy assessment after administration of IM study drug.|||units on a scale||Standard Error|Least Squares Mean
1378725|NCT01469052|Secondary|Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||L/hr||90% Confidence Interval|Geometric Mean
1378726|NCT01469052|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
1378727|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||hr||90% Confidence Interval|Mean
1378728|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||ng/mL||90% Confidence Interval|Geometric Mean
1378729|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||hr||Standard Deviation|Mean
1378730|NCT01469052|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||Liter/hr (L/hr)||95% Confidence Interval|Geometric Mean
1378731|NCT01469052|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)]|AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1378732|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||hr||Full Range|Median
1378733|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug.‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||Nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
1378734|NCT01469052|Primary|Maximum Tolerated Dose (MTD)|"MTD is defined as the dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD). DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity."|Baseline up to Day 28|Analysis population included all enrolled participants who received at least one dose of the study drug.|||mg BID|||Number
1378735|NCT01469039|Secondary|Clinical Global Impression - Improvement (CGI-I) Scores at Day 85|"The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse."|85 Days|FAS, defined as all randomized subjects who received at least 1 IM dose of study drug and had at least 1 primary efficacy assessment after administration of IM study drug.|||participants in category|||Number
1378737|NCT01469000|Secondary|Time to Worsening of Symptoms Using the Lung Cancer Symptom Scales (LCSS)||Baseline to Progressive Disease (Estimated Up To 18 Months)||2018-08-31|08/2018||||
1378738|NCT01469000|Secondary|Change From Baseline in Lung Cancer Symptom Scale (LCSS) Score(Symptom Control)||Baseline to Progressive Disease (Estimated Up To 18 Months )||2018-08-31|08/2018||||
1378739|NCT01469000|Secondary|Duration of Response (DoR)|DoR was defined as the time from the date of the first CR or PR to the first date of Progressive Disease (PD) ( RECIST 1.1 Criteria) or death from any cause.CR is the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression. Participants not known to have died or to have had progression of disease as of the data-inclusion cut-off date for a particular analysis,duration of tumor response was censored at the date of the participants last tumor assessment prior to that cut-off date.|First Observation of CR or PR to Progressive Disease or Death Due to Any Cause (Up To 30.29 Months)|All randomized participants who received at least 1 dose of drug had evaluable baseline and post baseline data. Participants censored: Gefitinib/Pemetrexed =30, Gefitinib=7|||months||95% Confidence Interval|Median
1378740|NCT01469000|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) (Disease Control Rate [DCR])|Disease control rate is the percentage of participants with a confirmed CR, PR or SD as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Randomization to Progressive Disease (Up To 31.38 months)|All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline data.|||percentage of participants|||Number
1378741|NCT01469000|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|ORR is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Partial Response (PR) is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.|Randomization to Progressive Disease (Up to 31.38 Months)|All participants who received at least 1 dose of study drug and had evaluable baseline and post baseline data.|||percentage of participants|||Number
1378742|NCT01469000|Secondary|Overall Survival (OS)||Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 50 Months)||2018-08-31|08/2018||||
1378743|NCT01469000|Secondary|Time To Progressive Disease (TTPD)|TTPD is defined as time from the date of randomization to the first date of disease progression. For each participant who is not known to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, or who has died without progression of disease, TTPD will be censored for that analysis at the date of the participant’s last tumor assessment prior to that cut-off date. TTPD was analyzed twice: (1) excluding clinical progressions of disease (that is,those not defined according to the RECIST version 1.1 criteria ), and (2) including clinical progressions. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to Progressive Disease (Up To 31.38 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =44, Gefitinib=9|||months||95% Confidence Interval|Median
1378744|NCT01469000|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization to the first date of objectively determined progressive disease or death from any cause, whichever is earlier. The censoring is taken in the following order: If a participant didn't have a complete baseline disease assessment, then the PFS time was censored at the enrollment date, regardless of whether or not objectively determined disease progression or death has been observed for the participant; otherwise, if a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 31.38 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =38, Gefitinib=9|||months||95% Confidence Interval|Median
1378745|NCT01468987|Secondary|Rapid Assessment of Physical Activity (RAPA) at 26 Weeks|The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant’s amount and intensity of physical activity, allowing each participant’s aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants’ physical activities that increase strength and improve flexibility. Each participant’s strength and flexibility activity level is then categorized as neither strength nor flexibility activity, either strength or flexibility activity (not both), both strength and flexibility activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, multiplied by 100.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
1378764|NCT01468987|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1378746|NCT01468987|Secondary|EuroQoL-5D (EQ-5D) at 26 Weeks|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥ 3]), and baseline EQ-5D score.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1378747|NCT01468987|Secondary|Low Blood Sugar Survey (LBSS) at 26 Weeks|LBSS (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM including stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline number of insulin injections [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline LBSS score.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1378748|NCT01468987|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥3]) as fixed effects and baseline value of the ITSQ scores as a covariate.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1378749|NCT01468987|Secondary|Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks|The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.|||participants|||Number
1378750|NCT01468987|Secondary|Lipid Profile at 26 Weeks|Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable], number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1378751|NCT01468987|Secondary|HbA1c at 26 Weeks|HbA1c is a test that measures a participant’s average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for stratification factors (country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1378752|NCT01468987|Secondary|0300-hour Blood Glucose to FBG Excursion at 26 Weeks|Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline excursion.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1378753|NCT01468987|Secondary|Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks|FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FBG variability.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1378754|NCT01468987|Secondary|Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks|LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FSG.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1378765|NCT01468896|Secondary|Time to Disease Progression (Phase II)|The Kaplan-Meier method will be used to estimate time to progression distributions.|From date of registration to date of progression, assessed up to 1 year||||months||95% Confidence Interval|Median
1378755|NCT01468987|Secondary|Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks|Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each post-baseline visit and stratification variables (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and baseline number of insulin injections [1, 2, or ≥3]).|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units/kg/day||Standard Error|Least Squares Mean
1378756|NCT01468987|Secondary|Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
1378757|NCT01468987|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
1378758|NCT01468987|Secondary|Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks|9-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to Weeks 0, 4, 12, and 26. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline BG values.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1378759|NCT01468987|Secondary|Body Weight Change From Baseline to 26 Weeks|LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline body weight as fixed effects, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
1378760|NCT01468987|Secondary|Percentage of Participants With Nocturnal Hypoglycemia Episodes|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
1378761|NCT01468987|Secondary|Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||events/participant/30 days||Standard Error|Mean
1378762|NCT01468987|Secondary|Percentage of Participants With Total Hypoglycemia Episodes|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
1378763|NCT01468987|Secondary|Total Hypoglycemia Rates (Adjusted for 30 Days)|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
1378766|NCT01468896|Secondary|Proportion of Patients Who Are Progression-free (Phase I)|Summarized by simple descriptive summary statistics. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||proportion of patients|||Number
1378769|NCT01468896|Secondary|Induction of Systemic Plasma Levels of Interferon-gamma|Explores graphically how changes in this marker differ between those with versus without an objective response to therapy as well as other potential factors.|Baseline up to day 50|Unable to compare the plasma levels of interferon-gamma between those with versus without an objective response to therapy due to no objective response seen for Phase I or Phase II patients.||||||
1378770|NCT01468896|Primary|Proportion of Patients Who Have Any Response to Treatment (Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors (Phase II)|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months||||proportion of patients|||Number
1378771|NCT01468896|Primary|Number of Dose-limiting Toxicity Incidents to Determine the Maximum Tolerated Dose of IL-12, Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)||14 days||||Dose limiting toxicities|||Number
1378772|NCT01468818|Secondary|Level of Persistence of the Transferred Cells in Blood|Determine level of transferred cells in the blood following a non-myeloablative lymphodepleting chemotherapy preparative regimen.|Once week and one month after transfer|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 35 subjects was needed to perform an analysis.||||||
1378773|NCT01468818|Primary|Objective Response in Patients With Metastatic Melanoma|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 2 Years||||participants|||Number
1378774|NCT01468675|Primary|Number of Subjects Who Discussed Disease Risk With Primary Care Provider||3 months following primary care visit|1673+1847 (Total=3520) is the total number of subjects who answered the question that this outcome is derived from. (During your last doctor visit, did you talk to your PCP about your risk of developing cancer, heart disease or diabetes.) The total number of subjects included in the analysis is 3703.|||Participants|||Count of Participants
1378775|NCT01468584|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1378776|NCT01468558|Primary|AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg*h/ml||Standard Deviation|Geometric Mean
1378777|NCT01468558|Primary|Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Geometric Mean
1378778|NCT01468350|Secondary|Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function|"Hand strength as measured by a composite Z-score derived from the grip test, and key, tip and palmar pinch tests~Manual dexterity as measured by the Box and Block Test~Walking speed as measured by the Timed 25 Foot Walk (T25FW)~Gait as measured by gait analysis equipment (to be performed by sites that have the capability to perform it)~For Part B only, subjective impressions of treatment as measured by:~Subject Global Impression (SGI)~Clinician Global Impression (CGI)"|up to 31 days|||||||
1378779|NCT01468350|Primary|Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)|"Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs)~TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study.~The severity categories of mild, moderate or severe, are defined below:~Mild is defined as causing no limitation of usual activities~Moderate is defined as causing some limitation of usual activities~Severe is defined as causing inability to carry out usual activities"|up to 31 days|Safety Population (Took at least one dose)|||participants|||Number
1378780|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 48 Compared to Baseline||Baseline and Week 48|||||||
1378781|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 48 Compared to Baseline||Baseline and Week 48|||||||
1378782|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 48 Compared to Baseline||Baseline and Week 48|||||||
1378783|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48|||||||
1378784|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48|||||||
1378785|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 2 Compared to Baseline||Baseline and Week 2|||||||
1378786|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 2 Compared to Baseline||Baseline and Week 2|||||||
1378787|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 2 Compared to Baseline||Baseline and Week 2|||||||
1378790|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48||||ETDRS letters|Participants|Full Range|Mean
1378791|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48||||ETDRS letters|Participants|Full Range|Mean
1378792|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2||||ETDRS letters|Participants|Full Range|Mean
1378793|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2||||ETDRS letters|Participants|Full Range|Mean
1378794|NCT01468337|Primary|Number of Participants Who Withdrew From the Study||Week 48||||participants|||Number
1378795|NCT01468337|Primary|Total Number of Non-ocular Adverse Events Related to the Investigational Product||Week 48||||Adverse Events|||Number
1378796|NCT01468337|Primary|Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product||Week 48||||Adverse Events|||Number
1378797|NCT01468337|Primary|Total Number of Ocular Adverse Events Related to Investigational Product||Week 48||||Adverse Events|||Number
1378798|NCT01468337|Primary|Total Number of Severe Ocular Adverse Events Related to the Investigational Product||Week 48||||Adverse Events|||Number
1378799|NCT01468311|Secondary|Overall Survival|Overall survival is defined as the time from the date of registration to the date of death due to any cause or if no death occurs to the last documented information on the patient.|OS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years||||months||Full Range|Median
1378800|NCT01468311|Secondary|Disease Free Survival (DFS)|DFS is defined as the amount of time participants remain disease free.|DFS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years||||months||Full Range|Median
1378801|NCT01468311|Secondary|Complete Response Rate|Complete response rate is defined as the time it takes a participant to achieve a complete response. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography (PET) negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size (<1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy); Previously involved nodes that were 1.1 to 1.5 cm in their long axis and more than 1.0 cm in their short axis before treatment must have decreased to <1.0 cm in their short axis after treatment.|20 months post autologous stem cell transplant||||months||Full Range|Median
1378802|NCT01468311|Secondary|Overall Response Rate|Overall response rate is defined as the number of complete and partial responses in patients with refractory or relapsed Hodgkin's disease. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography negative. Partial response requires all of the following: at least a 50% reduction in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least two perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.|Response is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years||||Participants|||Count of Participants
1378803|NCT01468311|Primary|Number of Participants With A Dose Limiting Toxicity|Patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of Carmustine, Etoposide, Cytarabine, [Ara-C, Cytosine Arabinoside] and Melphalan (BEAM) chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).|30 months||||Participants|||Count of Participants
1378804|NCT01468311|Primary|Number of Participants With Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|30 months||||Participants|||Count of Participants
1378805|NCT01468311|Primary|Maximum Tolerated Dose (MTD) of 90Y-daclizumab With Carmustine, Etoposide, Cytarabine, [Ara-C, Cytosine Arabinoside] and Melphalan (BEAM) and Auto Stem Cell Transplant (ASCT): Phase I Portion|The MTD is defined as the dose level below the dose at which 2 out of 2 to 6 patients at a given dose level develop dose limiting toxicity (DLT). A DLT is defined as patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of BEAM chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).|Day 100 post autologous stem cell transplant|MTD was not determined due to low enrollment into the study.||||||
1378806|NCT01468233|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population|||units on a scale||Standard Error|Least Squares Mean
1378807|NCT01468233|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) – at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3|||percentage of participants|||Number
1378808|NCT01468233|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II|||percentage of participants|||Number
1378809|NCT01468233|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage|||percentage of participants|||Number
1378810|NCT01468207|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population|||units on a scale||Standard Error|Least Squares Mean
1378811|NCT01468207|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) – At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) – at worst at Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3|||percentage of participants|||Number
1378812|NCT01468207|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II|||percentage of participants|||Number
1378813|NCT01468207|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage|||percentage of participants|||Number
1378814|NCT01468181|Secondary|Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)|The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HOMA2 data. LOCF was used to impute missing postbaseline values.|||percentage of HOMA2||Standard Error|Mean
1378815|NCT01468181|Secondary|Change From Baseline in Body Weight||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable body weight data. LOCF was used to impute missing postbaseline values.|||kilograms (kg)||Standard Error|Mean
1378816|NCT01468181|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable SMBG data. LOCF was used to impute missing postbaseline. values.|||mg/dL||Standard Error|Mean
1378817|NCT01468181|Secondary|Change From Baseline in Fasting Blood Glucose (FBG)||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable FBG data. LOCF was used to impute missing postbaseline values.|||milligrams/deciliters (mg/dL)||Standard Error|Mean
1378818|NCT01468181|Secondary|Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%||26 weeks and 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. LOCF was used to impute missing postbaseline values.|||percentage of participants|||Number
1378819|NCT01468181|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, up to 26 Weeks and up to 52 Weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. Last observation carried forward (LOCF) was used to impute missing postbaseline values.|||percentage of HbA1c||Standard Error|Mean
1378820|NCT01468181|Primary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug|||percentage of participants|||Number
1378821|NCT01468181|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug|||percentage of participants|||Number
1378822|NCT01468077|Secondary|Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Weeks 4, 8. 12, 20, and 24|ITT Completers|||Percentage of Participants|||Number
1378823|NCT01468077|Secondary|Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Baseline, Weeks 4, 8, 12, 20, and 24|ITT Completers|||scores on a scale||Standard Deviation|Mean
1378824|NCT01468077|Secondary|High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits|hsCRP is a marker for inflammation and is measured in milligrams per liter (mg/L). High levels of this protein indicate inflammation in diseases such as RA.|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||mg/L||Standard Deviation|Mean
1378825|NCT01468077|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits|ACR90 response is defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers|||Percentage of Participants|||Number
1378826|NCT01468077|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits|ACR70 response is defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers|||Percentage of Participants|||Number
1378827|NCT01468077|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits|ACR50 response is defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
1378828|NCT01468077|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits|ACR20 response is defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]).|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
1378829|NCT01468077|Secondary|DAS28 Score by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Baseline, Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers; n = the number of participants analyzed for the given parameter at the specific visit.|||scores on a scale||Standard Deviation|Mean
1378830|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
1378831|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
1378832|NCT01468077|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits|Improvement in Rheumatoid Arthritis (RA) disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response High sensitivity C-Reactive Protein (hsCRP), and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score less than (<)3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
1378833|NCT01468077|Secondary|Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits|Increased levels of high density lipoproteins (HDL) equal to or greater than (≥)1.5 millimoles per liter (mmol/L), and low density lipoproteins (LDL) ≥4.1 mmol/L, and total cholesterol ≥5.1 mmol/L, are defined according to the Adult Treatment Panel III (ATP-III) guidelines.|Screening and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
1378834|NCT01468077|Secondary|Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits|"Increased liver enzyme values defined as Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values of >1.5 times, or >3 times, or >5 times over the ULN. Almost none of the participants had increased measurements of AST, thus only values of ALT were presented. None of the participants presented with increased values of ALT above 3 or 5 ULN at any of the visits.~ITT Completers is defined as a subset of the participants in the ITT population who completed all study visits."|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers with liver enzyme datasets for each analyzed visit|||Percentage of Participants|||Number
1378835|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab for Other Reasons|Participants that stopped the administration of tocilizumab and discontinued the study prematurely due to reasons other than an AE or SAE were analyzed.|Baseline and Weeks, 4, 8, 12, 16, 20, and 24|SAS Population|||Percentage of Participants|||Number
1379729|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 2 (week 1)|||||||
1378837|NCT01468077|Primary|Percentage of Participants With Any Infusion Reaction|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.|Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20|Safety Analysis Set (SAS) Population: All randomized participants who received at least one infusion of tocilizumab.|||Percentage of Participants|||Number
1378838|NCT01468012|Primary|Retention in Treatment|The number of participants who completed the 12-week medication phase of the study.|12 weeks||||participants|||Number
1378839|NCT01468012|Primary|Cocaine Urine Toxicology|Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation|collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.|Urine toxicology results were not collected||||||
1378840|NCT01467960|Primary|Detection of Apolipoprotein D|Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)|Baseline||||microg / ml||Standard Deviation|Mean
1378841|NCT01467947|Secondary|Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies|Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months||||Subjects|||Number
1378842|NCT01467947|Primary|Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies|Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months||||subjects|||Number
1378843|NCT01467934|Primary|Fever >= 100.4||8 days|Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.|||percentage of participants|||Number
1378844|NCT01467882|Secondary|Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat boys, defined as all boys enrolled|||percentage of participants|||Number
1378845|NCT01467882|Secondary|Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat girls, defined as all girls enrolled|||percentage of participants|||Number
1378846|NCT01467882|Secondary|Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12||at Months 6 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
1378847|NCT01467882|Secondary|Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
1378848|NCT01467882|Secondary|Change From Baseline in Growth Velocity at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||cm/year||Standard Deviation|Mean
1378849|NCT01467882|Secondary|Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||percentile||Standard Deviation|Mean
1378850|NCT01467882|Secondary|Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||Z-score||Standard Deviation|Mean
1378851|NCT01467882|Secondary|Percentage of Children Without Higher Basal LH and Estradiol or Testosterone||at 2 days after second triptorelin injection (Day 171)|AOC Subset is defined as 50% of the population randomly assigned|||percentage of participants|||Number
1378852|NCT01467882|Secondary|Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||at Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
1378853|NCT01467882|Secondary|Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat boys, defined as all boys enrolled|||ng/dL||Standard Deviation|Mean
1378854|NCT01467882|Secondary|Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat girls, defined as all girls enrolled|||ng/L||Standard Deviation|Mean
1378855|NCT01467882|Secondary|Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled|||IU/L||Standard Deviation|Mean
1378856|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the lower than normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
1378857|NCT01467882|Secondary|Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12|This is a lab test to see what percentage of children were returned to lower than normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 6, 9 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
1378858|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
1378859|NCT01467882|Secondary|Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12|This is a lab test to see what percentage of children were returned to normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 9 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
1378860|NCT01467882|Primary|Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6|This is a lab test to see what percentage of participants were returned to normal before-puberty levels at Month 6.|Month 6|Intention to treat, defined as all participants enrolled|||percentage of participants||95% Confidence Interval|Number
1379730|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|26 week follow up|||||||
1378861|NCT01467713|Secondary|Quality of Life, Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score|Q-LES-Q-SF is a self-administered 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by patients in various areas of daily functioning. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes relative to baseline indicate improved quality of life.|Baseline and Months 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12|Participants from the Full Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy, with available data.|||percent of maximum total score||Standard Deviation|Mean
1378862|NCT01467713|Secondary|Time From Randomization to Study Withdrawal for Any Reason|The time from randomization to study withdrawal during the 12 month double-blind treatment period. Withdrawal includes pretreatment event/adverse event; liver function test abnormalities; major protocol deviation; lost to follow-up; voluntary withdrawal; study termination; pregnancy; lack of efficacy; participant has a depressive, mania/hypomania or mixed episode; is hospitalized for psychiatric reasons; receives electroconvulsive therapy for bipolar disorder; receives any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes; or any other reason.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy.|||days||Standard Error|Mean
1378863|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychotropic Medication Change Prescribed for the Treatment of Depression, Mania/Hypomania or Mixed Episodes|The time from randomization to relapse event during the 12 month double-blind treatment period due to any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episode(s).|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
1378864|NCT01467713|Secondary|Time From Randomization to Relapse Due to Electroconvulsive Therapy (ECT) Administration|The time from randomization to relapse event during the 12 month double-blind treatment period due to ECT.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
1378865|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychiatric Hospitalization for Bipolar Disorder|The time from randomization to relapse event during the 12 months double-blind treatment period due to psychiatric hospitalization for bipolar disorder.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
1378866|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mixed Episode|Relapse due to Mixed episode is determined by PI judgement and/or MADRS score ≥16 and YMRS total score ≥16. MADRS is a 10-item scale that measures overall severity of depressive symptoms rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
1378867|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania|Relapse due to mania/hypomania is determined by the primary investigator (PI) judgement and/or a YMRS total score ≥16. YMRS is a 11 item scale with four items scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to 12 Month double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
1378868|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression From PI Judgement and/or MADRS ≥16|The time from randomization to relapse event during the 12 month double-blind treatment period due to depression, determined by the PI judgement and/or a MADRS score ≥16. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
1378869|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode|Relapse due to mania/hypomania or mixed episode is determined by any of the following criteria: PI judgment, mania/hypomania [YMRS ≥16], mixed episode [MADRS ≥16 and YMRS ≥16], psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
1379731|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|12 week follow up|||||||
1378870|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression|Relapse due to depression determined by any of the following criteria during the 12-month double-blind treatment period: PI judgment, MADRS ≥16, psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of depressive episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||Days||Standard Error|Mean
1378871|NCT01467713|Primary|Time From Randomization to Any Relapse|The time from randomization to relapse over 12 months double-blind treatment period as determined by the Principal Investigator (PI) or defined by any of the following criteria: depression [Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥16]; mania/hypomania [Young Mania Rating Scale (YMRS) total score ≥14]; mixed episode [MADRS score ≥16 and YMRS total score ≥16]; or, whether participant receives psychiatric hospitalization for bipolar disorder, electroconvulsive therapy (ECT) or any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||Days||Standard Error|Mean
1378872|NCT01467700|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS comprises patient-rated items designed to measure the extent to which the subject’s life is impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities, are impaired by his or her symptoms on 10-point visual analogue scales from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. There are verbal descriptors for the points on the scales as well as numerical scores that provide more precise levels of the verbal descriptors. In addition, the SDS addresses the number of days lost and the number of days under-productive due to the symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
1378873|NCT01467700|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16 item QIDS-SR16 version is designed to assess the severity of depressive symptoms. The QIDS-SR16 assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition, DSM-IV, to diagnose a major depressive episode. QIDS-SR16 assessment has been used to screen for depression and also to measure symptom severity. This scale is also used to distinguish response from remission, as well as to quantify between group treatments effects in open label and randomized controlled trials. The patient is asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
1378874|NCT01467700|Secondary|Percentage of Participants With MADRS Remission at Week 6, With Remission Defined as a MADRS Total Score ≤10|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||percentage of participants|||Number
1378875|NCT01467700|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Week 6|"The CGI-S at week 6 relative to Baseline. The CGI-S assesses the clinician's impression of the participant's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
1378876|NCT01467700|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|6 Weeks|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
1378908|NCT01467505|Other Pre-specified|Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)||4 weeks after last planned dose of study drug (up to Week 52)|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
1378877|NCT01467700|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS total score at week 6 relative to baseline. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analyses with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
1378878|NCT01467700|Secondary|Percentage of Participants With MADRS Response at Week 6, With Response Defined as a ≥ 50% Decrease in the MADRS Total Score From Baseline|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||percentage of participants|||Number
1378879|NCT01467700|Secondary|Change From Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) Short Form Total Score at Week 6|Q-LES-Q -SF is a self-administered, 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are two global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of total possible score, with higher scores indicating better health status. A positive change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||percent of maximum score on a scale||Standard Error|Least Squares Mean
1378880|NCT01467700|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6|The change between MADRS score at week 6 relative to Baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A mixed measures repeated measures (MMRM) model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from full analysis set (FAS), all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
1378881|NCT01467661|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||participants|||Number
1378882|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).|||percentage of participants|||Number
1378883|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||percentage of participants|||Number
1378934|NCT01467479|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378884|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).|||percentage of participants|||Number
1378885|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||percentage of participants|||Number
1378886|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).|||percentage of participants|||Number
1378887|NCT01467661|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||percentage of participants|||Number
1378888|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number for participants evaluable at the specific category.|||percentage of participants|||Number
1378889|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number for participants evaluable at the specific category.|||percentage of participants|||Number
1378907|NCT01467557|Primary|Incidence of Adverse Events|Adverse events were reported by subjects via the electronic surveys if they responded “yes” to the question “Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?”. Consensus diagnosis was made after review of clinical records by Adjudication Panel.|Self-report at 2 Week, 4 Month or 12 Month surveys|The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)|||participants|||Number
1379732|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)|||||||
1378890|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.|||percentage of participants|||Number
1378891|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.|Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number of participants analysed at specific time point.|||percentage of participants|||Number
1378892|NCT01467661|Primary|Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.|||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
1378893|NCT01467661|Primary|Change From Baseline in Platelet Count at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
1378894|NCT01467583|Secondary|To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period|Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study|2 years||||participants|||Number
1378895|NCT01467583|Primary|To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.|Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay.|2 years||||mcg/ml||Standard Deviation|Mean
1378896|NCT01467570|Secondary|ORS Intake at 4 h|% of prescribed ORS that was consumed during first 4 hours|4 hrs||||percentage of prescribed ORS||Standard Deviation|Mean
1378897|NCT01467570|Secondary|Adverse Events|any adverse event, providing a description if related or not related to study intervention|24 hours||||participants|||Number
1378898|NCT01467570|Secondary|Hospitalization|need for hospitalization within a week|1 week||||participants|||Number
1378899|NCT01467570|Secondary|Return Visit to the Emergency Department|Return visit to the emergency department within a week|1 week||||participants|||Number
1378900|NCT01467570|Secondary|Duration of Diarrhea (Hrs)|Time of diarrhea in hours|7days||||hrs||Standard Deviation|Mean
1378901|NCT01467570|Secondary|Weight Gain in Gram|Weight gain in gram (in the first 24 hours, and total)|24 hours||||gram||Standard Deviation|Mean
1378902|NCT01467570|Secondary|ORS Intake in ml|ORS intake in ml (in the first 24 hours, and total)|24 hours||||ml||Standard Deviation|Mean
1378903|NCT01467570|Secondary|Vomiting|Vomiting starting or progressing in the first 24 hours of therapy|24 hours||||participants|||Number
1378904|NCT01467570|Secondary|Unscheduled Intravenous Therapy|Need for intravenous therapy within 24 hours|24 hours||||participants|||Number
1378905|NCT01467570|Primary|Number of Participants That Were Successfully Rehydrated|"The following components are included in primary outcome:~resolution of signs of dehydration~adequate weight gain~production of urine output during the trial"|Proportion of successfully rehydrated at 24 hours||||Participants|||Number
1378906|NCT01467557|Secondary|Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys|The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).|Baseline, 2 Week, 4 Month or 12 Month surveys|The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points.|||units on a scale||Standard Deviation|Mean
1379733|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)|||||||
1378909|NCT01467505|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 52|Safety Set included all participants who received at least 1 dose of study drug.|||participants|||Number
1378910|NCT01467505|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
1378911|NCT01467505|Secondary|Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
1378912|NCT01467505|Secondary|Percentage of Participants With Biopsy Confirmed and Treated Rejection||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
1378913|NCT01467505|Secondary|Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
1378914|NCT01467505|Secondary|Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
1378915|NCT01467505|Secondary|Percentage of Participants With Viral Relapse||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
1378916|NCT01467505|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.|Baseline up to Week 48|Safety Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1378917|NCT01467505|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378918|NCT01467505|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378919|NCT01467505|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|Safety Set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378920|NCT01467505|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378921|NCT01467492|Other Pre-specified|Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)||48 weeks|Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.||||||
1378922|NCT01467492|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.|up to Week 72|FA Set.|||participants|||Number
1378935|NCT01467479|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378923|NCT01467492|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety Set.|||percentage of participants|||Number
1378924|NCT01467492|Secondary|Percentage of Participants With On Treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48|FA Set.|||percentage of participants|||Number
1378925|NCT01467492|Secondary|Percentage of Participants With Virologic Breakthrough|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, and 12|FA Set.|||percentage of participants|||Number
1378926|NCT01467492|Secondary|Percentage of Participants With Relapse|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.|4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT|FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA <lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.|||percentage of participants|||Number
1378927|NCT01467492|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378928|NCT01467492|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last actual dose of study drug (up to Week 72)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378929|NCT01467492|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last actual dose of study drug (up to Week 60)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378930|NCT01467479|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.|Baseline, follow-up (Week 96)|Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.|||participants|||Number
1378931|NCT01467479|Secondary|Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)|Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.|Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir|Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1378932|NCT01467479|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety set.|||percentage of participants|||Number
1378933|NCT01467479|Secondary|Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.|EOT (up to Week 48)|Full analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1378936|NCT01467479|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)|SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|24 weeks after last planned dose of study drug (up to Week 72)|Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.|||percentage of participants|||Number
1378937|NCT01467479|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
1378938|NCT01467427|Secondary|Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)||From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)|||||||
1378939|NCT01467427|Secondary|Trough Level (Steady State)||From week 52 until the patient has completed the trial (no later than 31-Oct-2018)|||||||
1378940|NCT01467427|Secondary|Number of Bleeding Episodes During Prophylaxis||From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)|||||||
1378941|NCT01467427|Primary|Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)||From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)|||||||
1378942|NCT01467427|Secondary|Terminal Half-life (t1/2)||Week 0 (30 minutes until one week after first exposure)|Full analysis set.|||hours||Geometric Coefficient of Variation|Geometric Mean
1378943|NCT01467427|Secondary|Trough Level (Steady State)|The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. The estimated mean of the lowest activity recorded immediately before next dose was given from week 4 to week 52. The analysis is based on a mixed model on the log-transformed plasma concentrations with subject as a random effect and the mean trough level is presented back-transformed to the natural scale.|Week 4 to 52 weeks|Full analysis set.|||U/mL||95% Confidence Interval|Mean
1378944|NCT01467427|Secondary|Trough Level (Single-dose )|The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Geometric mean of the lowest activity of factor IX recorded at week 0 (immediately before next dose was given).|Week 0 (one week after first exposure)|Full analysis set. Number of subjects analysed=Subjects who were evaluable for this parameter.|||U/mL||Geometric Coefficient of Variation|Geometric Mean
1378945|NCT01467427|Secondary|Incremental Recovery at 30 Minutes (IR30min)|The incremental recovery was calculated by dividing the baseline-subtracted factor IX activity (U/mL) measured in plasma 30 min after dosing by the dose injected at time 0 expressed as U/kg body weight.|Week 0 (30 minutes after first exposure)|Full analysis set. Number of subjects analysed=Subjects who were evaluable for this parameter.|||(U/mL)/(U/kg)||Geometric Coefficient of Variation|Geometric Mean
1378946|NCT01467427|Secondary|Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)|"Description of the haemostatic effect of nonacog beta pegol when used for treatment of bleeding episodes was measured and listed according to the four point scale for haemostatic response as below:~Excellent – abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single infusion.~Good – noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection.~Moderate – probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one infusion within 8 hours.~Poor – no improvement, or worsening of symptoms within 8 hours after two injections.~A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures."|From 0 to 52 weeks|Full analysis set. Number of subjects analysed=subjects who experienced bleeding episodes.|||percentage of bleeding episodes|||Number
1378947|NCT01467427|Secondary|Number of Bleeding Episodes During Prophylaxis|The number of bleeding episodes per subject during routine prophylaxis was assessed using the individual annualised bleeding rates (bleeding episodes per subject per year).|From 0 to 52 weeks|Full analysis set (FAS) included all subject with efficacy data after exposure to nonacog beta pegol.|||bleeds/subject/year||Inter-Quartile Range|Median
1378948|NCT01467427|Primary|Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|From 0 to 52 weeks|Safety analysis set included all subjects exposed to nonacog beta pegol|||Number of subjects|||Number
1378949|NCT01467076|Secondary|Length of Hospital Stay||Up to one year|||||||
1378950|NCT01467076|Secondary|Number of Days of Oxygen (O2) Used, and Need for Supplemental Oxygen (O2)||28 Days of LIfe|||||||
1378951|NCT01467076|Secondary|Duration of Mechanical Ventilation||Until death or hospital discharge, up to on year|||||||
1378952|NCT01467076|Secondary|Need for Extracorporeal Membrane Oxygenation (ECMO)||Until death or hospital discharge, up to one year|||||||
1378953|NCT01467076|Secondary|Death||Up to one year|||||||
1378954|NCT01467076|Secondary|Duration of iNO Therapy||Until death or hospital discharge, up to one year|||||||
1378955|NCT01467076|Secondary|Need for INO 72 Hours After INO||72 hours after INO|||||||
1378956|NCT01467076|Secondary|Improvement in Oxygenation Index (OI)||72 Hours|||||||
1378957|NCT01467076|Secondary|Improvement in Partial Pressure of Oxygen in the Blood (PaO2)||72 hours|||||||
1379734|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 10 (week 5)|||||||
1378958|NCT01467076|Primary|Assess Feasibility to Recruit at Least 50 Infants|The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (>20%) protocol violations.|9 months after 75% of the participating sites are enrolling|Late preterm & term infants ≤ 7 days postnatal age undergoing conventional ventilation (CNV) or high frequency oscillatory ventilation (HFOV) for NHRF (including perinatal aspiration syndrome, suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic PPHN or suspected pulmonary hypoplasia) with suboptimal response to INO|||participants|||Number
1378959|NCT01467037|Other Pre-specified|Vaccine Effectiveness of RV1|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.~Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. RV1 VE was estimated as (1 − exposure odds ratio) × 100. Based upon our sampling scheme, the exposure odds ratio from our analyses approximates the rate ratio."|From February 1, 2012 to May 31, 2014||||adjusted VE||95% Confidence Interval|Number
1378960|NCT01467037|Primary|Matched VE Participants|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.~We estimated RV1 VE of 2- versus 0-doses and ≥1- versus 0-doseto prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. Children vaccinated with RV5 (private market,minimal penetrance) were excluded."|From February 1, 2012 to May 31, 2014|Rotavirus vaccination history by rotavirus disease status among matched VE participants|||participants|||Number
1378961|NCT01466881|Other Pre-specified|Aurora Kinase A Expression|To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237|Baseline|Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.|||proportion of positivity||Standard Deviation|Mean
1378962|NCT01466881|Secondary|To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1378963|NCT01466881|Secondary|Progression Free Survival (PFS)|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Patients last known to be alive and without report of progressive disease are censored at date of last contact. Progressive disease is at least 50% increase in the sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions over the smallest sum observed. New bone marrow involvement. New lesion > 1.5 cm in longest axis, or ≥ 50% increase in GTD of any previously involved node with a diameter ≤ 1.0 cm in the short axis such that its longest axis is now > 1.5 cm. Lymph nodes with long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm. PET should be positive if positive PET at baseline.|Up to 2 years after registration|Only eligible patients were included in the analysis|||Months||95% Confidence Interval|Mean
1378964|NCT01466881|Secondary|Overall Survival (OS)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years after registration|Only eligible patients were included in the analysis.|||Months||95% Confidence Interval|Median
1378965|NCT01466881|Primary|Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to 1 year after registration|All eligible patients who started treatment were included in assessing response estimates.|||participants|||Number
1378966|NCT01466790|Secondary|Number of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.|During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
1378967|NCT01466790|Secondary|Number of Participants With Inadequate Virologic Response|Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.|Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
1378968|NCT01466790|Secondary|Number of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.|Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
1378969|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) at Week 48|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.|Week 48|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
1378970|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.|Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
1378971|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.|Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
1378972|NCT01466790|Primary|Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.|Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
1378973|NCT01466764|Secondary|Total Length of Hospital Stay|Total length of hospital stay for patients enrolled in the study.|Up to approximately 5 days maximum (admittance to discharge)||||hours||Standard Deviation|Median
1378974|NCT01466764|Secondary|Assess Rates of Wound Dehiscence|Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.|Up to 72 hours following surgery plus 3 weeks follow-up||||Participants|||Count of Participants
1378975|NCT01466764|Secondary|Count of Participants With Venous Thrombosis After Surgery During Hospitalization|Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.|Up to 72 hours following surgery plus 3 weeks follow-up||||Participants|||Count of Participants
1378976|NCT01466764|Secondary|Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital|Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.|Up to 72 hours following surgery plus 3 weeks follow-up||||Participants|||Count of Participants
1378977|NCT01466764|Secondary|Post-operative Pain Intensity|Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)|Up to 72 hours following surgery|Participants with available data were analyzed.|||units on a Visual Analog scale||Full Range|Mean
1378978|NCT01466764|Secondary|Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery|"Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study.~PCA/IV: Patient controlled Analgesia/ Intravenous"|Up to 72 hours following surgery||||Participants|||Count of Participants
1378979|NCT01466764|Primary|Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.|Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery. Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1|Up to 72 hours following surgery|IL-1ra measurements were invalid due to cross-reaction with the assay platform.||||||
1378980|NCT01466673|Secondary|Change From Baseline in Body Weight at Month 6|Change from Baseline in body weight is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Kilograms||Standard Deviation|Mean
1378981|NCT01466673|Secondary|Change From Baseline in Blood Pressure (BP) at Month 6|Blood pressure is the pressure of blood flowing through blood vessels. Change from Baseline in blood pressure is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Millimeters of Mercury||Standard Deviation|Mean
1378982|NCT01466673|Secondary|Number of Participants With Treatment Response at the End-of-Therapy by Participant’s Self-Assessment at Month 6|Participant’s self-assessment at end-of-therapy was measured by using the self-assessment questionnaire which included 3 questions, about the rating of acne improvement since start of study; comparison of this acne treatment with the one used in past and the continuity of treatment on physician’s prescription to evaluate efficacy and acceptability of the study medication. The score was graded at 4 parameters as excellent, better, no change and worse.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."|||Participants|||Number
1378983|NCT01466673|Secondary|Percentage of Participants Showing Treatment Response on the Investigator’s Global Assessment at Month 6|Percentage of participants showing treatment response on the Investigator’s global assessment was graded on a 5-point scale as 0=worse, 1=no change, 2=fair, 3=good, and 4=excellent.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."|||Percentage of participants|||Number
1378984|NCT01466673|Secondary|Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6|Sebum assessment that is facial seborrhea (very oily skin) was assessed using sebutape strip on the forehead. Percentage of participants with facial seborrhea were assessed using categorical scores ranging from level 1 (lowest) to level 5 (highest). Highest level indicates worsening.|Baseline and Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of Participants|||Number
1378985|NCT01466673|Secondary|Number of Participants Non-Compliant With Therapy|Compliance was assessed by transforming the data of forgotten tablets listed in the diary cards. Number of participants who forgot to take the drug was reported.|Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Participants|||Number
1378986|NCT01466673|Secondary|Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6|Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day.|Month 1, 3 and 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Participants|||Number
1378987|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Lesions||Standard Deviation|Mean
1378988|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 3|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Lesions||Standard Deviation|Mean
1378989|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 1|Intent-to-treat population (ITT) included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||Lesions||Standard Deviation|Mean
1378990|NCT01466660|Secondary|Health-related Quality of Life|"Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS).~EQ-5D utility scores range from 0 (worst health) to 1 (full health).~EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).~Results display the mean score up to 56 weeks."|Every 8 weeks, up to 56 weeks|Randomised set including patients with available HRQoL data|||Units on a scale||95% Confidence Interval|Least Squares Mean
1378991|NCT01466660|Secondary|Tumour Shrinkage|Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with tumour assessments|||millimetre (mm)||95% Confidence Interval|Least Squares Mean
1378992|NCT01466660|Secondary|Duration of Disease Control|Duration of disease control was measured from randomisation to the time of progressive disease (PD) or death, whichever occurred first (or date of censoring for progression free survival (PFS))|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with disease control|||Months||95% Confidence Interval|Median
1378993|NCT01466660|Secondary|Disease Control|Disease control which was defined as objective response (complete response or partial response) or stable disease (SD).|From first drug administration until last drug administration, up to 1293 days|Randomised set|||Percentage of participants||95% Confidence Interval|Number
1378994|NCT01466660|Secondary|Duration of Objective Response|Duration of objective response defined as the time of first objective response to the time of progression or death, whichever occurred first (or date of censoring for progression free survival (PFS))|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with objective response|||Months||95% Confidence Interval|Median
1378995|NCT01466660|Secondary|Time to Objective Response|"Number of participants with objective response over time, cumulative number of participants is displayed.~Time to objective response was defined as the time from randomisation to the first recorded objective response."|From first drug administration until last drug administration, up to 1293 days|Randomised set including patients with objective response|||Participants|||Number
1379010|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 12|Change in hsCRP from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 ng/mL||Inter-Quartile Range|Median
1378996|NCT01466660|Secondary|Objective Response Rate|Objective response rate (ORR) which was defined as the number of participants with complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST v1.1. for target lesions and assessed by CT-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Overall Response (OR) = CR + PR|From first drug administration until last drug administration, up to 1293 days|Randomised set|||Percentage of participants||95% Confidence Interval|Number
1378997|NCT01466660|Primary|Overall Survival|Overall survival (OS) which was defined as the time from the date of randomisation to the date of death.|From first drug administration until last drug administration, up to 1482 days|Randomised set|||Months||95% Confidence Interval|Median
1378998|NCT01466660|Primary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.|From first drug administration until last drug administration, up to 1293 days|Randomised set|||Months||95% Confidence Interval|Median
1378999|NCT01466660|Primary|Progression-free Survival|Progression-free survival (PFS) defined as the time from the date of randomisation to the date of disease progression, or to date of death if a patient died earlier. Disease progression was primarily evaluated by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.|From first drug administration until last drug administration, up to 1293 days|Randomised set|||Months||95% Confidence Interval|Median
1379000|NCT01466595|Secondary|Primary Adverse Events|Primary adverse events include all SAEs, defined according to ICH guidelines and targeted protocol events (grade 2 or higher signs and symptoms, grade 2 or higher laboratory abnormality, all diagnoses identified by the ACTG criteria for clinical events, and all events that led to a change in treatment regardless of grade).|from study enrollment until study completion at 12 weeks||||participants|||Number
1379001|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 12|Change in total CD4 T-cell count from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||cells/mm3||Inter-Quartile Range|Median
1379002|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 12|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 12.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||MFI (relative intensity)||Inter-Quartile Range|Median
1379003|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 12|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
1379004|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12|||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
1379005|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12|||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
1379006|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage CD38+ of CD8+||Inter-Quartile Range|Median
1379007|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12|||percentage CD38+ of CD4+||Inter-Quartile Range|Median
1379008|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 12|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
1379009|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 12|Change in soluble CD14 from week 4 to week 12|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 ng/mL||Inter-Quartile Range|Median
1379011|NCT01466595|Secondary|Change in LPS From Week 4 to Week 12|Change in LPS from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 pg/mL||Inter-Quartile Range|Median
1379012|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 12|Change in IL-6 from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 pg/mL||Inter-Quartile Range|Median
1379013|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 12|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 ng/mL||Inter-Quartile Range|Median
1379014|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 12|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who had data for both week 4 and week 12, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
1379015|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 8|Change in total CD4 T-cell count from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||cells/mm3||Inter-Quartile Range|Median
1379016|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 8|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 8.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||MFI (relative intensity)||Inter-Quartile Range|Median
1379017|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 8|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
1379018|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
1379019|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
1379020|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage CD38+ of CD8+||Inter-Quartile Range|Median
1379021|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage CD38+ of CD4+||Inter-Quartile Range|Median
1379022|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 8|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
1379023|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 8|Change in soluble CD14 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 ng/mL||Inter-Quartile Range|Median
1379024|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 8|Change in hsCRP from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 ng/mL||Inter-Quartile Range|Median
1379025|NCT01466595|Secondary|Change in LPS From Week 4 to Week 8|Change in LPS from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 pg/mL||Inter-Quartile Range|Median
1379026|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 8|Change in IL-6 from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 pg/mL||Inter-Quartile Range|Median
1379027|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 8|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 ng/mL||Inter-Quartile Range|Median
1379028|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 8|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who had data for both week 4 and week 8, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8.|||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
1379029|NCT01466595|Secondary|Change in CD4 Count From Baseline to Week 4|Change in total CD4 T-cell from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||cells/mm3||Inter-Quartile Range|Median
1379030|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Baseline to Week 4|"Change in CD38+ of CD8+ MFI (Median Fluorescence Intensity) from baseline to week 4, where baseline value is the average of pre-entry and entry.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||MFI (relative intensity)||Inter-Quartile Range|Median
1379031|NCT01466595|Secondary|Change in %HLA-DR+/CD38+ of CD4+ From Baseline to Week 4|Change in CD4 activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
1379032|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
1379033|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
1379034|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage CD38+ of CD8+||Inter-Quartile Range|Median
1379035|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage CD38+ of CD4+||Inter-Quartile Range|Median
1379036|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cell From Baseline to Week 4|Change in gut-homing percent B7hi+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
1379197|NCT01464931|Secondary|Time to Maximum Observed Serum Denosumab Concentration (Tmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|PK Parameter Analysis Set|||days||Full Range|Median
1379037|NCT01466595|Secondary|Change in sCD14 From Baseline to Week 4|Change in soluble CD14 (sCD14) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 ng/mL||Inter-Quartile Range|Median
1379038|NCT01466595|Secondary|Change in hsCRP From Baseline to Week 4|Change in High Sensitivity C-reactive Protein (Hs-CRP) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 ng/mL||Inter-Quartile Range|Median
1379039|NCT01466595|Secondary|Change in LPS From Baseline to Week 4|Change in Lipopolysaccharide (LPS) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 pg/mL||Inter-Quartile Range|Median
1379040|NCT01466595|Secondary|Change in IL-6 From Baseline to Week 4|Change in Interleukin (IL)-6 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 pg/mL||Inter-Quartile Range|Median
1379041|NCT01466595|Secondary|Change in D-dimer From Baseline to Week 4|"Change in D-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry.~D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 ng/mL||Inter-Quartile Range|Median
1379042|NCT01466595|Primary|Change in CD8+ T-cell Activation From Baseline to Week 4|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where the baseline value is the average of pre-entry and entry values.|At baseline and 4 weeks|The primary analysis is as-treated, limited to subjects who had data for both baseline and week 4, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change antiretroviral therapy (ART) or use prohibited medications or have virologic failure during this time period.|||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
1379043|NCT01466491|Secondary|Pain Scores Throughout Procedure at Various Time Points|"Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure:~prior to medication (baseline)~after speculum insertion~with placement of PCB~with cervical dilation~with aspiration~30 minutes post-operatively"|up to several hours||||mm||Standard Error|Mean
1379044|NCT01466491|Primary|Patient Perception of Pain|To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation.|At time of uterine aspiration (baseline)||||mm||Standard Deviation|Mean
1379045|NCT01466387|Secondary|Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone|In addition to the AEs and SAEs. Additional AESI were collected from day 1 to day 57 postvaccination in subjects after the vaccination of Japanese encephalitis and rabies virus vaccines given concomitantly with MenACWY-CRM197 or alone.|day 1 to day 57 post last vaccination|Analysis was done on the safety data set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||subjects|||Number
1379046|NCT01466387|Secondary|Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection of anti-rabies virus antibody concentrations 28 days after vaccination of the third dose of rabies virus vaccine, when administered alone or concomitantly either with Japanese encephalitis or with Japanese encephalitis and MenACWY-CRM197 vaccines.~Seroprotection is defined as percentages of subjects who achieved anti-rabies virus antibody concentrations ≥ 0.5 IU/mL on day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
1379047|NCT01466387|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197|The immunogenicity was assessed in rabies virus vaccine as measured by geometric mean rabies virus neutralizing antibody concentration, 28 days after vaccination of the third dose, when administered alone or concomitantly either with Japanese encephalitis vaccine or with Japanese Encephalitis and MenACWY-CRM197 vaccines.|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.|||IU/mL||95% Confidence Interval|Geometric Mean
1379057|NCT01466387|Primary|Geometric Mean Anti-Yellow Fever Antibody Titer|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1379048|NCT01466387|Secondary|Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.~Seroresponse is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post last vaccination (day 29 or day 57)|The analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
1379049|NCT01466387|Secondary|Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.|Baseline and 1 month post last vaccination (day 29 or day 57).|The analysis was done on the MITT data set.|||titers||95% Confidence Interval|Geometric Mean
1379050|NCT01466387|Secondary|Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.~Seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥1:4, seroresponse is defined as a postvaccination hSBA titer of at least four times the baseline."|1 month postvaccination (day 29)|The analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
1379051|NCT01466387|Secondary|Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone|Immunogenicity was assessed by Serum Bactericidal Assay using human complement (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the MITT data set.|||titers||95% Confidence Interval|Geometric Mean
1379052|NCT01466387|Secondary|Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-rabies neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.~Seroprotection is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a post-vaccination hSBA titer of at least 4 times the baseline."|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
1379053|NCT01466387|Secondary|Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-Japanese encephalitis neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.~Seroprotection is defined as percentages of subjects who achieved anti-JE neutralizing titers ≥ 1/10 on Day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.|||Percentages of subects||95% Confidence Interval|Number
1379054|NCT01466387|Secondary|Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-YF neutralizing antibody titers after the vaccination of typhoid Vi polysaccharide and yellow fever, given alone or concomitantly with MenACWY-CRM197 on day 29.~Seroprotection is defined as percentages of subjects who achieved anti-YF neutralizing antibody titers ≥ 1/10 on day 29."|Baseline and 1 month postvaccination (day 29).|Analysis was done on the Modified-Intention to Treat (MITT) set, i.e. the subjects who provided evaluable serum samples whose assay results are available for at least one antigen on baseline and on at least one post-baseline visit.|||Percentages of subjects||95% Confidence Interval|Number
1379055|NCT01466387|Primary|Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||IU/mL||95% Confidence Interval|Geometric Mean
1379056|NCT01466387|Primary|Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the PP set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1379058|NCT01466387|Primary|Geometric Mean Anti-typhoid Vi Antibody Concentrations|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||El.U/mL||95% Confidence Interval|Geometric Mean
1379059|NCT01466361|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|"AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.~SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect."|Baseline, 0 minute, 60 minutes and 5 days post treatment|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.|||participants|||Number
1379060|NCT01466361|Secondary|Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group|Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.|Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm||||percentage|||Number
1379061|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 3 minutes and 15 minutes post-treatment|ITT population: All randomized participants who had at least one cravings assessment measurement post dose.|||Score on a scale||Standard Error|Least Squares Mean
1379062|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 1, 3, 5, 10 and 15 minutes post-treatment|Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data.|||Score on a scale||Standard Error|Least Squares Mean
1379063|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test|Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with ‘not at all’ and the right hand end with ‘extremely’. For each question, ‘9’ represented the ‘best’ score and ‘1’ represented the ‘worst’ score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Error|Mean
1379064|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Responses||Standard Error|Mean
1379065|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Mean
1379066|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of ‘s’ (visual) or ‘8’ (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Error|Mean
1379067|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Mean
1379068|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Responses||Standard Error|Mean
1379069|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter ‘s’ every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number ‘8’ every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Error|Mean
1379070|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Responses||Standard Error|Mean
1379071|NCT01466348|Secondary|Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||milliseconds (msec)||Standard Error|Mean
1379072|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Deviation|Mean
1379073|NCT01466348|Primary|Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 30 minutes post treatment administration|Intent-To-Treat (ITT) population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Deviation|Mean
1379074|NCT01466270|Secondary|Fatigue|Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.|24 weeks|All randomized participants except two who did not provide any data.|||units on a scale||Standard Error|Least Squares Mean
1379075|NCT01466270|Secondary|HVLT-IR|Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.|24 weeks|All randomized participants except two who did not provide any data.|||number of words recalled||Standard Error|Least Squares Mean
1379076|NCT01466270|Primary|Compliance|Compliance is the percentage of pills taken while on study (based on returned diaries)|24 weeks|Participants who returned pill diaries. Note that some participants did not return diaries so the numbers of participants for this analysis may not agree with the numbers for other analyses.|||percentage of pills||Full Range|Mean
1379077|NCT01466270|Primary|Retention|Retention is the percentage of participants who stay in the study for 24 weeks.|24 Weeks|All randomized patients|||percentage of participants||Standard Error|Mean
1379078|NCT01466192|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1379096|NCT01466153|Secondary|Overall Survival (OS)|OS was determined as the time from the start of treatment with study drug until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Number
1379079|NCT01466179|Secondary|Best Response During the Core Study|"Complete Remission (CR):~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL~Complete Remission With Partial Hematological Recovery (CRh*):~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL~Blast Free Hypoplastic or Aplastic Bone Marrow:~bone marrow blasts ≤ 5%~no evidence of disease~insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL~Partial Remission:~• bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline."|From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1379080|NCT01466179|Secondary|Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment|"Blast Free Hypoplastic or Aplastic Bone Marrow was defined as:~bone marrow blasts ≤ 5%~no evidence of disease~insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or absolute neutrophil count (ANC) ≤ 500/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1379081|NCT01466179|Secondary|Serum Cytokine Peak Levels|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.~Serum IL-4 levels were below detection limit (< 20 pg/mL) at all time points in all participants studied."|Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.|Pharmacodynamic Data Set (PDS): All patients who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected. N indicates the number of participants with available data at each time point.|||pg/mL||Standard Deviation|Mean
1379082|NCT01466179|Secondary|Serum Blinatumomab Concentration at Steady State|The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.|Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.|Pharmacokinetic Data Set (PKS) defined as all patients who received any infusion of blinatumomab and had at least one PK sample collected unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption or sampling information was missing.|||pg/mL||Standard Deviation|Mean
1379083|NCT01466179|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in remission (CR/CRh*) following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~Patients alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of patients having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods."|From the date of allogeneic HSCT until the data cut-off date of 10 October 2013; median observation time was 7.4 months.|Participants who received an allogeneic HSCT while in remission induced by blinatumomab treatment.|||percentage of participants||95% Confidence Interval|Number
1379084|NCT01466179|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~An AE was considered “serious” if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.~Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.|Full analysis set (FAS), defined as all patients who received any infusion of blinatumomab.|||participants|||Number
1379085|NCT01466179|Secondary|Overall Survival|Overall survival was measured for all participants from the time the participant received the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan Meier method.|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set|||months||95% Confidence Interval|Median
1379097|NCT01466153|Secondary|Progression Free Survival (PFS)|PFS was measured from the start of treatment with study drug until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
1379214|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
1379086|NCT01466179|Secondary|Event-free Survival|"Event-free survival was calculated from the start date of blinatumomab infusion until the date of bone marrow aspiration at which hematological relapse was first detected, or the date of diagnosis on which the hematological or extramedullary relapse was documented or the date of start of any new therapy for ALL (excluding HSCT), or the date of death, whichever was earlier. Participants who did not achieve complete remission or complete remission with partial hematological recovery during the core study were evaluated as having an event on Day 1. Participants in remission who did not experience hematological relapse, did not receive a new therapy for ALL (excluding HSCT), and did not die were censored on the date of the last available bone marrow aspiration or on the last date of survival follow-up visit, whichever was later.~Event free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set|||months||95% Confidence Interval|Median
1379087|NCT01466179|Secondary|Relapse-free Survival|"Relapse-free survival was assessed for participants who achieved a complete remission or complete remission with partial hematological recovery during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.~Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.9 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study|||months||95% Confidence Interval|Median
1379088|NCT01466179|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1379089|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Complete Remission With Partial Hematological Recovery was defined by the following criteria:~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1379090|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"Complete Remission was defined by the following criteria:~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1379091|NCT01466179|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.|Up to the data cut-off date of 10 October 2013. Maximum duration on study was 17.8 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the first 2 cycles of treatment.|||percentage of participants||95% Confidence Interval|Number
1379092|NCT01466179|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.~Hematological relapse is defined as:~proportion of blasts in bone marrow > 5% after documented CR/CRh* or~blasts in peripheral blood after documented CR/CRh*.~Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.|||months||95% Confidence Interval|Median
1379093|NCT01466179|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.~Hematological remissions were defined by the following criteria:~Complete Remission (CR):~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL~Complete Remission With Partial Hematological Recovery (CRh*):~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|The Primary Analysis Set (PAS), defined as participants from the first 3 stages of the study who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
1379094|NCT01466153|Secondary|Terminal Half Life (t1/2) of MEDI-551|Terminal phase elimination half-life (T1/2) was the time required for half of the drug to be eliminated from the serum.|Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1|The safety population includes all participants who received any investigational product. Participants whom PK samples were available were analyzed for this outcome measure.|||Day||Standard Deviation|Mean
1379095|NCT01466153|Secondary|Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA)|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|The safety population includes all participants who received any investigational product. Participants whom ADA samples were available were analyzed for this outcome measure.|||Participants|||Number
1379098|NCT01466153|Secondary|Time to Disease Progression (TTP)|TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or – in the absence of any diagnosis of progressive disease – until the participant´s death.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
1379099|NCT01466153|Secondary|Time to Response|Time to response was evaluated using the Kaplan-Meier method.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
1379100|NCT01466153|Secondary|Minimal Residual Disease Negative Complete Response (CR) Rate|The MRD-negative CR rate was defined as the percentage of participants who achieved CR and became MRD-negative as determined by flow cytometry. CR as per International Working Group (IWG) was complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Percentage of Participants||95% Confidence Interval|Number
1379101|NCT01466153|Secondary|Complete Response Rate|Complete response was as per IWG was the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Percentage of Participants||95% Confidence Interval|Number
1379102|NCT01466153|Secondary|Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs|AEs observed in participants with clinically significant ECG abnormalities were assessed.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.|||Participants|||Number
1379103|NCT01466153|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.|||Participants|||Number
1379104|NCT01466153|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug (MEDI-551). A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 90 that were absent before treatment or that worsened relative to pre-treatment state. An AESIs was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through Day 90 after the last dose of study drug.Hepatic function abnormality and infusion reactions resulting in discontinuation were considered as AESIs.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.|||Participants|||Number
1379105|NCT01466153|Primary|Objective Response Rate|ORR, defined as the proportion of participants with complete response (CR) or partial response (PR) out of total number of participants. Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Percentage of Participants||95% Confidence Interval|Number
1379106|NCT01466127|Primary|Differential Skin Conductance Response (SCR) During the First Two Extinction Trials|Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.|Day 2 of Conditioning (1 day post Day 1 of Conditioning)||||micro-Siemens (square rooted)||Standard Deviation|Mean
1379107|NCT01466075|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system.|1 hour|Blood data for three subjects were not considered evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.|||participants|||Number
1379108|NCT01466075|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma).|1 hour|609 venous BG results(203 subjects x 3 test strip lots) were available. Three subjects did not have successful venipunctures so no blood obtained. BGMS testing was not performed with one subject's blood sample. Study staff tested each subject venous blood sample using 3 test strip lots.|||percentage of Blood Glucose Test Results|Participants||Number
1379193|NCT01464931|Secondary|Number of Participants Who Developed Anti-denosumab Antibodies||From Day 1 (predose) to Day 113|Safety analysis set|||participants|||Number
1379241|NCT01464359|Secondary|Duration of Survival||2 years after Transplantation.||||Participants|||Count of Participants
1379109|NCT01466075|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. The remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.|||percentage of Blood Glucose Test Results|Participants||Number
1379110|NCT01466075|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution Investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.|||percentage of Blood Glucose Test Results|Participants||Number
1379111|NCT01466062|Secondary|Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121|The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.|Screening, Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.|||participants|||Number
1379112|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121|Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||mg/dL||Standard Deviation|Mean
1379113|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121|Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||U/L||Standard Deviation|Mean
1379114|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121|Normal ranges for RBC and platelet count varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||cells *10^4/µL||Standard Deviation|Mean
1379115|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121|Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.|||cells *10^3/µL||Standard Deviation|Mean
1379116|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121|Normal range for hematocrit varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||percentage of red blood cells||Standard Deviation|Mean
1379117|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121|Normal range for hemoglobin varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||g/dL||Standard Deviation|Mean
1379118|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Weight at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||kilograms||Standard Deviation|Mean
1379119|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||beats per minute||Standard Deviation|Mean
1379120|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||respirations per minute||Standard Deviation|Mean
1379121|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||degrees Celcius||Standard Deviation|Mean
1379122|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n= number of participants with measurements at given time points.|||mm Hg||Standard Deviation|Mean
1379123|NCT01466062|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants|||participants|||Number
1379124|NCT01466062|Secondary|Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants who required any of the investigated treatments for RSV. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.||||||
1379125|NCT01466062|Secondary|Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection|Number of days of hospitalization caused by RSV infection.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants hospitalized. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.||||||
1379126|NCT01466062|Secondary|Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Percentage of participants who required any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants|||percentage of participants||95% Confidence Interval|Number
1379127|NCT01466062|Secondary|Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection||From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants|||percentage of participants||95% Confidence Interval|Number
1379128|NCT01466062|Primary|Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121|Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).|Day 1 (Screening), Day 31, Day 121|All participants; n=number of non-missing observations.|||µg/mL||Standard Deviation|Mean
1379129|NCT01465997|Primary|Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)|A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.|Up to 3.5 Years (Duration of the Treatment Phase)||||Participants|||Count of Participants
1379130|NCT01465997|Primary|Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)|Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.|Up to 3.5 Years (Duration of the Treatment Phase)||||Participants|||Count of Participants
1379131|NCT01465997|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)|Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.|Up to 3.5 Years (Duration of the Treatment Phase)||||Participants|||Count of Participants
1379132|NCT01465958|Primary|Mean Trough of Serum Total IgG|Mean trough serum total IgG values were calculated for each subject for the IV Phase (IV #1 and IV #2) and the SC phase (SC Weeks #9 and #12, and End of Treatment/Early termination visit). Mean trough concentration values of serum total IgG during the IV and SC phases were calculated based on the IgG population (subjects who received any amount of study drug and had serum total IgG concentration data).|4 - 5 weeks of IV administration and 12 weeks for SC administration|The IgG Population was used to calculate the trough serum concentrations. The IgG population consisted of all subjects who received any amount of GAMUNEX-C and had any serum total IgG concentration data.|||mg/dL||Full Range|Mean
1379133|NCT01465958|Primary|Steady-state Area Under the Curve (AUC) for Serum Total Immunoglobulin (IgG)|Steady-state area under the curve (AUC): For the IV phase, the mean adjusted AUC was calculated for all 11 subjects, which included subjects on both 3 and 4 week intravenous (IV) dosing schedules and who had sufficient immunoglobulin G (IgG) data. For the SC phase, the mean AUC was calculated for 10 subjects on weekly subcutaneous (SC) administration and who had sufficient IgG data.|4 to 5 weeks for IV administration; 12 weeks for SC administration|The PK population included the subjects with the availability of sufficient pharmacokinetics (PK) data to calculate area under the curve (AUC) for either the IV or SC phases.|||h*mg/dL||Full Range|Mean
1379134|NCT01465802|Secondary|Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.~Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1379194|NCT01464931|Secondary|Percent Change From Baseline in Serum C-Telopeptide Over Time||Baseline and Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacodynamic Analysis Set (all participants who received at least 1 dose of denosumab and from whom baseline and at least 1 postbaseline value was collected)|||percent change||Inter-Quartile Range|Median
1379242|NCT01464359|Secondary|Duration of Survival||1 year after Transplantation.||||Participants|||Count of Participants
1379135|NCT01465802|Secondary|Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.~Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1379136|NCT01465802|Secondary|Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I|CL/F was calculated as dose/AUCtau.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
1379137|NCT01465802|Secondary|Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||hr||Full Range|Median
1379138|NCT01465802|Secondary|Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Cmax was obtained from direct inspection of the data.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1379139|NCT01465802|Secondary|Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1379140|NCT01465802|Primary|Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.|||hours (hr)||Full Range|Median
1379141|NCT01465802|Primary|Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1379142|NCT01465802|Primary|Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|"AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.~ng*hr/mL = nanogram hours per milliliter"|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1379143|NCT01465802|Secondary|Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III|Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).|Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)|As Treated Population|||Percentage of Participants|||Number
1379144|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II|"PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.~Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Skindex Analysis Population|||Score on a scale||Standard Deviation|Mean
1379195|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2|Estimated using the linear trapezoidal method.|Days 29 (predose), 36, 43, 57, 71, and 85|PK Parameter Analysis Set|||μg*day/mL||Standard Deviation|Mean
1379145|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
1379146|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
1379147|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II|"Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.~Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).~M/T = mouth and throat."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Modified OMDQ Analysis Population; participants meeting primary endpoint analysis & modified OMDQ specific criteria: a) Modified OMDQ completion criteria for initial visit & end of Cycle 2 or EoT visit; b) Completion criteria for at least 5 of 6 visits between initial & end of Cycle 2 visit. n = number of participants completing scale.|||Score on a scale||Standard Deviation|Mean
1379148|NCT01465802|Primary|Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
1379149|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I|"Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.~Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|First 8 Weeks of Treatment|PRO Skindex Analysis Population: participants that met primary endpoint analysis & Skindex specific criteria: a) Skindex completion criteria (as above) for initial visit & end of Cycle 2 or EoT visit; b) Skindex completion criteria for at least 5 of 6 visits between initial visit & end of Cycle 2 visit. n = number of participants completing scale.|||Score on a scale||Standard Deviation|Mean
1379150|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).~95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
1379151|NCT01465802|Primary|Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.~95% confidence interval (CI) calculated using exact method based on binomial distribution.~After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population - included all participants who received the study treatment assigned at enrollment, but did not discontinue dacomitinib treatment less than 6 weeks from first dosing due to either disease progression or death.|||Percentage of Participants||95% Confidence Interval|Number
1379152|NCT01465763|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Baseline, Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1379153|NCT01465763|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1379154|NCT01465763|Secondary|Partial Mayo Scores|A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1379155|NCT01465763|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379156|NCT01465763|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379157|NCT01465763|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379158|NCT01465763|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379159|NCT01465763|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379160|NCT01465763|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379161|NCT01465763|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|Full analysis set (FAS) included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379162|NCT01465412|Secondary|Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
1379196|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1|Estimated using the linear trapezoidal method.|Days 1, 8, 15, and 29 (predose)|PK Parameter Analysis Set|||μg*day/mL||Standard Deviation|Mean
1379243|NCT01464359|Secondary|Duration of Survival||6 months after Transplantation.||||Participants|||Count of Participants
1379163|NCT01465412|Secondary|AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
1379164|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
1379165|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
1379166|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
1379167|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
1379168|NCT01465412|Primary|Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
1379169|NCT01465412|Primary|Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
1379170|NCT01465386|Primary|Progression Free Survival (PFS)|Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow|Up to 2 years|Patient who began maintenance treatment with bortezomib after induction of remission|||days|Participants|Full Range|Median
1379171|NCT01465347|Secondary|Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction|The sum of the product of the diameters of the tumor (using recorded tumor diameter measurements made from brain MRI images) was used to express tumor size. Results were summarized for actual and percentage change from baseline. Individual subjects results were listed, including tumor volume and tumor response from independent reviewers. Investigator data were listed but not used in the analysis. Percent response (according to independent reviewer assessments) by percentage tumor reduction from tumor resection or definitive biopsy to the last MRI were summarized.|From Baseline to Week 110|Of the 56 modified ITT population (subjects in the TSC 18 dose group) tumor size data exist for 37 subjects. Four (4) tumor-bearing subjects at baseline MRI did not have any post-baseline MRIs. Fourteen (14) subjects had a complete resection before baseline.|||Participants|||Count of Participants
1379172|NCT01465347|Secondary|Progression-Free Survival (PFS)|The PFS analyses were performed using the Kaplan-Meier estimate method. The PFS rates at 6, 12, 18 and 24 months were estimated. Median PFS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. Time to disease progression (in months) was calculated as follows: date of event* or censoring - date of surgery or definitive biopsy / 30.4375; *event = first tumor progression or death.|6,12,18, 24 months|The analysis of PFS was performed in phase 2 only and included the modified ITT population which included 54 of the 56 subjects (98.2%) at the 2-year time point.|||percentage of participants||95% Confidence Interval|Number
1379735|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 9 (week 5)|||||||
1379173|NCT01465347|Primary|Overall Survival|Participants in phase 2 (18 dose group, 6 weeks treatment with TSC) were monitored for up to 3 years (last follow-up - February 16, 2016). Overall Survival (OS) was defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death. The OS analyses were performed using the Kaplan-Meier estimate method. The OS rates at 6, 12, 18 and 24 months were estimated. Median OS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. The length of OS (in months) was calculated as follows: date of death or censored - date of surgery or definitive biopsy / 30.4375.|6, 12, 18, 24 months|All participants who received any amount of TSC and at least 1 session of RT (modified ITT)|||participants||95% Confidence Interval|Number
1379174|NCT01465347|Primary|Dose Limiting Toxicities (DLTs)|Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)|During phase 1|Dose limiting toxicities were only assessed for Phase 1 participants|||Participants|||Count of Participants
1379175|NCT01465230|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|36 months|Participants withdrew from study before primary outcome could be measured||||||
1379176|NCT01465178|Secondary|Change in Parameters of the Vitamin D Assay Panel|Secondary outcomes are change in cholecalciferol, 24,25(OH)D3 and free 25(OH)D3.|Baseline, 1 and 4 months post supplementation|Postmenopausal Caucasian women with 25(OH)D < 10 > 30 ng/ml|||ng/ml||Standard Deviation|Mean
1379177|NCT01465178|Primary|Change in Serum 25-hydroxy Vitamin D3|Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;|Baseline, 1 and 4 months post supplementation||||ng/ml||Standard Deviation|Mean
1379178|NCT01465048|Secondary|Dynamics of Plasmodium Falciparum Parasite Growth Following PfSPZ Challenge Administered in Various Regimens|To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge|||||||
1379179|NCT01465048|Secondary|Frequency, Incidence and Nature of Adverse Events and Serious Adverse Events Arising.|To assess the safety of PfSPZ Challenge administered in various regimens by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements, including lab reports and adverse events.|Participants will be followed for the duration of the study, an expected average of 3 months|||||||
1379180|NCT01465048|Primary|Number of Participants Infected|To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge||||Participants|||Number
1379181|NCT01465022|Secondary|Infant Occipitofrontal Circumference Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."|||cm||Standard Deviation|Mean
1379182|NCT01465022|Secondary|Infant Weight Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."|||kg||Standard Deviation|Mean
1379183|NCT01465022|Secondary|Infant Length Growth From 2-8 Weeks|Comparison of infant length at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."|||cm||Standard Deviation|Mean
1379184|NCT01465022|Secondary|Number of Participants Who Continued Birth Control Method After 6 Months|Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period|||participants|||Number
1379185|NCT01465022|Primary|Number of Participants Who Continued to Breastfeed at 6 Months|Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period|||participants|||Number
1379186|NCT01464996|Secondary|Post Operative Sensitivity|Percentage of restorations with alfa scores. No sensitivity.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
1379187|NCT01464996|Secondary|Marginal Adaptation and/or Integrity|Percentage of restorations with alfa scores. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
1379188|NCT01464996|Secondary|Anatomic Form|Percentage of restorations with alfa scores. Restoration is continuous with existing anatomic form.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
1379189|NCT01464996|Secondary|Secondary Caries|Percentage of restorations with alfa scores. Absence of caries is evidenced by softness, opacity, or etching at the margin of the restoration.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
1379190|NCT01464996|Secondary|Cavosurface Margin Discoloration|Percentage of restorations scoring alfa. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
1379191|NCT01464996|Secondary|Color Match|Percentage of restorations that scored alfa. Restoration matches adjacent tooth structure in color, shade and translucency.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
1379192|NCT01464996|Primary|Retention|Overall retention of restorations|6 and 18 months post-baseline|what is reported here is the retention rate using the restoration as the unit of analysis|||percentage of restorations|Participants||Number
1379198|NCT01464931|Secondary|Maximum Observed Serum Denosumab Concentration (Cmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacokinetic (PK) Parameter Analysis Set (all participants who received at least 1 dose of denosumab and for whom PK parameter estimates could be derived)|||μg/mL||Standard Deviation|Mean
1379199|NCT01464931|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The investigator assessed whether AEs were possibly related to study drug by answering the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?” Abnormal laboratory findings without clinical significance (based on the investigator's judgment) were not recorded as AEs, however, laboratory value changes that required treatment or adjustment in current therapy were considered AEs. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life-threatening (places the participant at immediate risk of death), • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event.|113 days|Safety analysis set|||participants|||Number
1379200|NCT01464931|Secondary|Percent Change From Baseline in Serum Magnesium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point|||percent change||Inter-Quartile Range|Median
1379201|NCT01464931|Secondary|Percent Change From Baseline in Serum Phosphorus Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point|||percent change||Inter-Quartile Range|Median
1379202|NCT01464931|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point|||percent change||Inter-Quartile Range|Median
1379203|NCT01464931|Secondary|Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria|The severity of hypomagnesemia (a low concentration of magnesium in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (1.5 mg/dL) - 1.2 mg/dL; Grade 2: < 1.2 - 0.9 mg/dL; Grade 3: < 0.9 - 0.7 mg/dL; Grade 4: < 0.7 mg/dL.|113 days|Safety analysis set|||participants|||Number
1379204|NCT01464931|Secondary|Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria|The severity of hypophosphatemia (a low concentration of phosphates in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (3 mg/dL) - 2.5 mg/dL; Grade 2: < 2.5 - 2.0 mg/dL; Grade 3: < 2.0 - 1.0 mg/dL; Grade 4: < 1.0 mg/dL.|113 days|Safety analysis set|||participants|||Number
1379205|NCT01464931|Secondary|Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria|The severity of hypocalcemia (a low concentration of calcium, corrected for albumin, in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: albumin-adjusted serum calcium < lower limit of normal (LLN; 9.2 mg/dL) to 8.0 mg/dL; Grade 2: albumin-adjusted serum calcium < 8.0 to 7.0 mg/dL; Grade 3: albumin-adjusted serum calcium < 7.0 to 6.0 mg/dL; Grade 4: albumin-adjusted serum calcium < 6.0 mg/dL.|113 days|Safety analysis set|||participants|||Number
1379206|NCT01464931|Primary|Number of Participants With Clinically Significant Hypocalcemia|Clinically significant hypocalcemia is defined as albumin-adjusted calcium < 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.|113 days|Safety Analysis Set (all participants who received at least 1 dose of denosumab)|||participants|||Number
1379207|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Tmin||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
1379208|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cmin||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
1379209|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cavg||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
1379210|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cmax||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
1379211|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Tmax||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
1379212|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng*hr/dL||Standard Deviation|Mean
1379213|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
1379736|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 8 (week 4)|||||||
1379215|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cavg||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
1379216|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
1379217|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
1379218|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng*hr/dL||Standard Deviation|Mean
1379219|NCT01464879|Secondary|Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.||Days 1-7|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||percentage of subjects|||Number
1379220|NCT01464879|Primary|Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.|Descriptive statistics was used to present the outcome results.|Days 15-21, Days 22-28 & Days 29-35|Full Analysis Set (FAS) population was used for this analysis, which comprised of all subjects who had any available Pharmacokinetic (PK) data.|||percentage of subjects|||Number
1379221|NCT01464840|Primary|Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration|The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.|48 hours after delivery|No patients had azithromycin concentrations at least equivalent to the MIC 90.|||number of participants|||Number
1379222|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
1379223|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
1379224|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
1379225|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
1379226|NCT01464827|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin|"The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G)."|Post Treatment Week 24|Intent-to-treat population (all participants who received at least 1 dose of direct-acting antiviral agent); participants with missing data were counted as non-responders.|||percentage of participants|||Number
1379244|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 1 year from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only until the resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|1 Year from Transplantation||||Participants|||Count of Participants
1379227|NCT01464827|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:~Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).|Safety population. Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.|||participants|||Number
1379228|NCT01464788|Primary|Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration|Symptomatic intracranial hemorrhage (sICH) is defined as any evidence of bleeding on CT scan that in the opinion of the treating physician and/or an independent safety monitor is associated with a clinically significant neurological worsening. A four or more point increase in the NIHSS score from baseline (or last score obtained prior to blood found on CT scan) to subsequent CT scan at the time of potential worsening can be used as a guide by the clinical investigator or safety monitor for what represents a significant worsening in neurologic status but sICH can include any worsening deemed significant by the clinical investigator or independent safety monitor.|48-hours|One patient in the high dose group did not receive Argatroban and another in the high dose group was lost to follow up; however, an intention-to-treat analysis was used and all 31 enrolled patients were included.|||participants|||Number
1379229|NCT01464788|Primary|Number of Participants With 0 or 1 on Modified Rankin Scale|Excellent functional outcome as measured by the number of patients with a 0 or 1 on the modified Rankin Scale (mRS) at day 90 as assessed by study personnel blinded to treatment.|90 days|One patient in the high dose group did not receive Argatroban and another in the high dose group was lost to follow up; however, an intention-to-treat analysis was used and all 31 enrolled patients were included.|||participants|||Number
1379230|NCT01464619|Secondary|Change in Parenting Discipline|Change from baseline to follow-up of the Parenting Scale (PS), a validated self-report measure of parents' self-reported parenting discipline. Total scores range from 1 to 7 with lower scores indicating better parenting discipline.|3 months||||units on a scale||Standard Deviation|Mean
1379231|NCT01464619|Secondary|Change in Social Support|Change from baseline to follow-up of the Multidimensional Scale of Perceived Social Support (MSPSS), a validated self-report measure of perceived social support from family, friends, and a significant other. Total scores range from 12 to 84 with higher scores indicating greater perceived social support.|3 months||||units on a scale||Standard Deviation|Mean
1379232|NCT01464619|Secondary|Change in Parenting Stress|Change from baseline to follow-up of the Parenting Stress Index-Short Form Total (PSI-SF), a validated self-report measure of parenting stress. Total scores range from 36 to 180 with higher scores indicating greater levels of parenting stress.|3 months||||units on a scale||Standard Deviation|Mean
1379233|NCT01464619|Secondary|Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.|3 months||||participants|||Number
1379234|NCT01464619|Secondary|Attendance at 6 or More Incredible Years (IY) Sessions|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of IY.|3 months||||percentage of subjects enrolled|||Number
1379235|NCT01464619|Secondary|Acceptability of the Parent Coaching Intervention|"Acceptability of the parent coaching intervention will be assessed by a response to the question How did you like the parenting program? at the conclusion of the parent sessions. the responses ranged from 1 (highly disliked) to 5 (highly liked)"|3 months|No satisfaction measures were collected from the control group, as they received the intervention in a delayed format after their study participation had ended.|||units on a scale||Standard Deviation|Mean
1379236|NCT01464619|Secondary|Change in Caregiver Depressive Symptoms|Change from baseline to follow-up of the Beck Depression Scale-II (BDI-II), a validated self-report measure of depressive symptoms. The scale range is from 0 to 63 with higher scores indicating worse depressive symptoms.|3 months||||units on a scale||Standard Deviation|Mean
1379237|NCT01464619|Primary|Feasibility of a Parent Coaching Intervention|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.|3 months|Original number who enrolled and were assigned to each group.|||participants|||Number
1379238|NCT01464424|Primary|Overall Mean Intraocular Pressure (IOP)|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.|Week 6|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.|||millimeters mercury (mmHg)||Standard Deviation|Mean
1379239|NCT01464424|Secondary|Mean IOP at Each After Office Hour Evaluation Timepoint|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.|Week 6: 4 pm, 6 pm, 8 pm|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.|||millimeters mercury (mmHg)||Standard Deviation|Mean
1379240|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 2 years from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only untilthe resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|2 Years from Transplantation||||Participants|||Count of Participants
1379248|NCT01464359|Primary|Disease Free Survival|The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo.|At 3 months||||participants|||Number
1379249|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With Calibration Every 12 Hours|This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and paired YSI plasma glucose values for sensors inserted in the Buttock insertion site, with Calibration every 12 hours, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
1379250|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day|This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose value and paired YSI plasma glucose measurement for sensors inserted in the Buttock insertion site, with 3-4 Calibrations, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
1379251|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours|This is a measure of Mean Absolute Relative Difference (MARD) between the sensor and the paired YSI plasma glucose value for sensors inserted in the Abdomen insertion site, with Calibration every 12 hours, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
1379252|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day|This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and and paired YSI plasma glucose values for Abdomen insertion site, with 3-4 Calibrations, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
1379253|NCT01464346|Secondary|Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion|Secondary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI <75 mg/dL) with 3-4 calibrations per day, combined abdomen and buttock insertion sites across all participants and all days.|Days 1, 3 and 6 of sensor wear||||percentage of paired readings||95% Confidence Interval|Mean
1379254|NCT01464346|Primary|Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites|Primary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI <75 mg/dL) with the minimum calibration (every 12 hour), combined abdomen and buttock insertion sites across all participants and all days.|Days 1, 3 and 6 of sensor wear||||percentage of paired readings||95% Confidence Interval|Mean
1379255|NCT01464307|Secondary|Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, ‘n’ specifies those subjects who were evaluated for this outcome measure at given time point.|Baseline, Week 4, 8, and 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.|||Units on a scale||Standard Deviation|Mean
1379256|NCT01464307|Secondary|Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)|Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4, 8, and 12|"The FAS included subjects in SES of main period for whom primary efficacy variable was available, whereby SES is subset of all subjects who were exposed to IP in main period at least once. Here, “N”(Number of Participants Analyzed) and n signifies those participants who were evaluable for this outcome measure and at given time point respectively."|||Percentage of Participants|||Number
1379257|NCT01464307|Primary|Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12|A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.|Baseline to Week 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.|||Percentage of Participants|||Number
1379258|NCT01464307|Primary|Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Baseline and Week 4|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.|||Units on a scale||Standard Deviation|Mean
1379259|NCT01464255|Primary|Lens Fit – Post-Blink Lens Movement Prior to Removal|The ophthalmologist’s objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
1379260|NCT01464255|Primary|Lens Fit – Post-Blink Lens Movement After Insertion|The ophthalmologist’s objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
1379261|NCT01464255|Secondary|Overall Lens Pair Preference|Participant’s subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
1379262|NCT01464255|Secondary|Overall Preference – Handling, Removing|Participant’s subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
1379263|NCT01464255|Secondary|Overall Preference – Handling, Inserting|Participant’s subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
1379264|NCT01464255|Secondary|Overall Preference – Dryness Before Removal|Participant’s subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
1379265|NCT01464255|Secondary|Overall Preference – Dryness After Insertion|Participant’s subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
1379266|NCT01464255|Secondary|Overall Preference – Comfort Before Removal|Participant’s subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
1379267|NCT01464255|Secondary|Overall Preference – Comfort After Insertion|Participant’s subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices – Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
1379268|NCT01464255|Primary|Lens Fit – Tightness at One Week|The ophthalmologist’s rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||percentage of tightness||Standard Deviation|Mean
1379269|NCT01464255|Primary|Lens Fit – Tightness After Insertion|The ophthalmologist’s rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||percentage of tightness||Standard Deviation|Mean
1379270|NCT01464255|Primary|Lens Fit – Decentration at One Week|The ophthalmologist’s objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
1379271|NCT01464255|Primary|Lens Fit – Decentration After Insertion|The ophthalmologist’s objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
1379272|NCT01464229|Primary|SQ Anger/Hostility Scale|"Of the 20 patients randomized, data was analyzed for 13 completers. Symptom Questionnaire (SQ) Anger/Hostility Scale; this is a 23-item subscale of the 92-item Symptom Questionnaire.~This score ranges from 0 to 23; higher values represent higher anger and hostility."|9 weeks||||Score on Anger/Hostility Scale||Standard Deviation|Mean
1379273|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.|||pg/mL||Standard Deviation|Mean
1379274|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Calcium|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.|||mg/dL||Standard Deviation|Mean
1379275|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Phosphorus|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.|||mg/dL||Standard Deviation|Mean
1379276|NCT01464021|Secondary|Percent Change From Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI)|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
1379277|NCT01464021|Secondary|Percent Change From Baseline in Physician’s Global Assessment of RA Disease Activity|A horizontal VAS (100 mm) measure of the physician's global assessment of the participant’s current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
1379278|NCT01464021|Secondary|Percent Change From Baseline in Patient’s Assessment of Pain|A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
1379279|NCT01464021|Secondary|Percent Change From Baseline in Patient’s Global Assessment of Disease Activity|A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
1379280|NCT01464021|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
1379281|NCT01464021|Secondary|Percent Change From Baseline in C-reactive Protein|C-reactive protein level in serum (mg/dL)|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
1379282|NCT01464021|Secondary|Percent Change From Baseline in Tender and Swollen Joint Counts|Change in number of tender joints and swollen joints for 28 assessed joints.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||Percent change||Standard Deviation|Mean
1379283|NCT01464021|Secondary|Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available|||percent change||Standard Deviation|Mean
1379737|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 7 (week 4)|||||||
1379284|NCT01464021|Primary|Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1"|Week 12|Participants who received at least 6 consecutive injections of adalimumab (every other week) and have the necessary clinical data for both the Baseline and the Week 12 visit available.|||participants|||Number
1379285|NCT01463982|Secondary|Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)|"by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100.~Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100.~Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100."|tumor response evaluation can continue to receive the study drug until PD confirmation||||percentage of participants||95% Confidence Interval|Number
1379286|NCT01463982|Primary|Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination|If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)|Cycle 1 (21 days)||||percentage of participants||95% Confidence Interval|Number
1379287|NCT01463878|Secondary|Quadriceps Muscle Volume|The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.|First versus last measurment in ICU. Up to 14 days (average 7 days)|||||||
1379288|NCT01463878|Primary|Glycemic Variability|The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.|Entire ICU stay. Up to 14 days in the ICU (average about 7 days)||||mg/dl (MAGE)||Standard Deviation|Mean
1379289|NCT01463696|Secondary|AUC at Time of Last Sample (AUClast) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
1379290|NCT01463696|Secondary|Area Under the Concentration Time Curve From Hour 0 to Hour 12 (AUC0-12) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 and Day 7, Hour 0 through Hour 12|The APaT population consisted of all participants who received at least one dose of study drug.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
1379291|NCT01463696|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours postdose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.|||Hours||Full Range|Median
1379292|NCT01463696|Secondary|Maximum Observed Plasma Concentration (Cmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8,and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 24 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||nM||Geometric Coefficient of Variation|Geometric Mean
1379293|NCT01463696|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as: any drug-related hematologic toxicity ≥ Grade 3 lasting ≥1 week, ≥ Grade 3 thrombocytopenia with bleeding, ≥ Grade 3 neutropenia with infection OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions/clarifications: 1) Grade 3 nausea, vomiting, diarrhea, and dehydration were excluded from the determination of DLT if, in the opinion of the investigator and sponsor, they occurred in a setting of inadequate treatment, 2) Grade 3 nausea, vomiting, diarrhea, and dehydration were each considered a DLT if they persisted despite 72 hours of maximal supportive care measures or 3) Any abnormal non-hematological laboratory value ≥ Grade 3 (that is not attributable to any other causes) was considered a DLT only if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for ≥1 week.|Cycle 1 (21 days)|The DLT-evaluable population consisted of participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 (dose escalation) or the dose confirmation portion of Part 2, or discontinued due to toxicity.|||Participants|||Number
1379294|NCT01463683|Primary|Percentage of Participants With Pyrexia Adverse Events|Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis|||Percentage of participants|||Number
1379295|NCT01463683|Primary|Percentage of Participants With Injection-site Adverse Events|Participants were evaluated for injection-site adverse events using MedDRA version 15.1|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis|||Percentage of participants|||Number
1379296|NCT01463683|Primary|Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection|Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.|Month 7|The per protocol population consisted of all randomized participants who met enrollment criteria, did not violate the protocol, were seronegative at Baseline, and had vaccination and blood collection. Seroprotection was evaluated only for participants receiving vaccine subcutaneously; intramuscular vaccination was evaluated for safety only.|||Percentage of participants|||Number
1379297|NCT01463631|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113||Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose|Participants who received at least one dose of study drug and had sufficient evaluable Cmax values.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1379298|NCT01463631|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113||Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose|Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-tau) values.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1379299|NCT01463631|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113||Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose|Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-inf) values.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1379300|NCT01463631|Secondary|The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed.|Baseline through Study Completion (up to 170 Days)|Participants in Part B who received at least one dose of study drug and were radiologically assessed for tumor response.|||percentage of participants|||Number
1379301|NCT01463631|Primary|Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)|Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline through Study Completion (up to 170 Days)|Participants who received at least one dose of study drug.|||Participants|||Count of Participants
1379302|NCT01463527|Secondary|Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.|While there were 77 patients per group, each patient had vital signs measured every 30 seconds for the duration of their stay. This resulted in a variable amount of time points (data points) recorded per patient. Our event frequency was the number of events (outcome measure of abnormal vital signs) per number of time points for each patient. This is presented as an event rate.|Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)||||rate of total events/total time points|Total Number of Time Points per Group|Full Range|Mean
1379303|NCT01463527|Primary|Frequency of Staff Interventions for Hypoventilation.|These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.|Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)||||Events per patient minute of sedation||Full Range|Mean
1379304|NCT01463384|Primary|Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)|"It has been demonstrated in numerous studies over the past decade that magnetic resonance spectroscopy (MRS) can be used for the diagnosis of Alzheimer’s disease. By measuring an area within the posterior cingulate gyrus, one can obtain a biochemical signature of that region in AD whereby NAA is reduced and mI is increased.~These two biomarkers, N-acetylaspartate (NAA, a neuronal marker) and myo-inositol (mI, a glial marker) were quantified and then used to calculate NAA/mI (an index currently widely used for AD and MCI diagnosis).~Scale of MRS biomarkers for aged-matched controls: NAA = 1.43, mI = 0.60, NAA/mI = 2.38. Any value lower than NAA/mI of 2.38 are considered not normal.~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)||||Ratio||Standard Deviation|Mean
1379305|NCT01463384|Primary|Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).|"Using magnetic resonance images acquired, hippocampal volume was measured monthly for 6 months.~Normal range for hippocampal volume in aged-matched controls is 6.6 - 8.8 cm^3.~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)||||cm^3||Standard Deviation|Mean
1379306|NCT01463384|Primary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|"RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial skills. RBANS was developed as a stand-alone “core” battery for the detection and neurocognitive characterization of dementia and as a brief neurocognitive battery for the detection and tracking of neurocognitive deficits in a variety of disorders. (Reference: http://rbans.com/)~Qualitative Description of Index Scores:~Index Score Classification 130 and above Very Superior 120-129 Superior 110-119 High Average 90-109 Average 80-89 Low Average 70-79 Borderline 69 and below Extremely Low~Psychometric range for RBANS:~AD 0 - 77 MCI 78 - 99 Normal > 100~Range of scores: Minimum = 0, Maximum = 130~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)||||units on a scale||Standard Deviation|Mean
1379315|NCT01463293|Primary|Whole Gut Transit Time|The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28|4 weeks|Only 39 out of the 224 enrolled subjects consumed the radio-opaque markers in line with the protocol. Because of the substantial number of protocol deviations and the lack of sufficient evaluable subjects, no further analyses of the study data were performed. The study appears not to have yielded evaluable data.||||||
1379316|NCT01463202|Secondary|Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA|Exclusive breastfeeding at specific time intervals postpartum|2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum|Two participants withdrew during follow-up|||Participants|||Count of Participants
1379317|NCT01463202|Secondary|Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA|Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression|8 weeks postpartum|Excludes 14 participants with a missed call at 8 weeks postpartum|||scores on a scale||Inter-Quartile Range|Median
1379318|NCT01463202|Secondary|Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA|Use of DMPA, IUD, implant, or sterilization|6 months||||Participants|||Count of Participants
1379319|NCT01463202|Primary|Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA|Any breastfeeding at specific time intervals postpartum|2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum|1 ppt withdrawn postrandomization due to enrollment violation (did not meet eligibility criteria)|||Participants|||Count of Participants
1379320|NCT01463111|Secondary|Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score|The BIS-11 is a 30 item self-report questionnaire, used to assess three factors of impulsivity: 1). attentional impulsiveness, reflecting a difficulty concentrating or tolerating cognitive complexity, 2). motor impulsiveness, reflecting a tendency to act before thinking, and 3). non-planing impulsiveness, reflecting a lack of forethought about potential consequences. Items are scored on a 4-point scale: Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4. Attentional impulsivity scores range from 8-32. Motor impulsivity scores range from 11-44. Non-planning impulsivity scores range from 11-44. Total BIS-11 scores range from 30-120. A higher score reflects higher impulsivity across all sub-types.|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
1379321|NCT01463111|Primary|Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. The procrastination decision-making style involves putting off making decisions. Scores range from 0-10. A higher score indicates that the procrastination decision-making style is used more and is considered a worse score."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
1379322|NCT01463111|Primary|Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. The buckpassing decision-making style represents a tendency to leave decisions to others. Scores range from 0-12. A higher score indicates that the buckpassing decision-making style is used more frequently and represents a worse score."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
1379323|NCT01463111|Primary|Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. Hypervigilance is marked by hurried, anxious decision-making. Scores range from 0-10. A higher score indicates a worse score and that a hyper-vigilant decision making style is used more frequently."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
1379324|NCT01463111|Primary|Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|The MDMQ is a 22-item self report form assessing four different styles of decision making. Vigilance is considered the healthy, adaptive, decision-making style, reflecting consideration of an array of outcomes and ultimately rational decision-making. Scores range from 0-12. A higher score indicates that vigilance is used more frequently during decision making. A higher score indicates healthier decision making.|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
1379325|NCT01463033|Secondary|Adverse Events|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period.|30 day treatment period|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Symptoms reported to be moderate or severe are listed. Adverse events were not monitored for the Observational group.|||Events|||Number
1379326|NCT01463033|Primary|Post-Traumatic Epilepsy|occurrence of PTE (Post-Traumatic Epilepsy)|2 years||||participants|||Number
1379327|NCT01463007|Secondary|Cosmetic Outcome|Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.|2 years||||participants|||Number
1379328|NCT01463007|Primary|Early and Intermediate Toxicity|Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.|2 years||||participants|||Number
1379361|NCT01462565|Secondary|Number of Participants With Infusion Site Reactions During Treatment Period|Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis.|Baseline visit (Visit 2) to Week 4 (Visit 3)|ITT population.|||Participants|||Count of Participants
1379329|NCT01462942|Secondary|Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score|SGRQ is a standardised, self-administered tool for measuring impaired health and perceived well-being in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact) Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100: zero (0) score indicating no impairment of quality of life The total SGRQ score ranging from 0 to 100 is a summary score utilising responses to all items calculated using weights attached to each item of the questionnaire Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status|Baseline and Week 24||||Score on a scale||Standard Error|Least Squares Mean
1379330|NCT01462942|Secondary|Change in Transition Dyspnoea Index (TDI) Focal Score|Evaluation of dyspnea was performed by an independent interviewer experienced in taking a respiratory history The TDI includes three categories: functional impairment which determines the impact of breathlessness on the ability to perform activities, magnitude of task which determines the type of task that caused breathlessness and magnitude of effort which establishes the level of effort needed to evoke breathlessness Each category ranges from minus three (-3; major deterioration) to plus three (+3; major improvement) including a zero (0) score to indicate 'no change' The three categories are totalled to obtain a focal score (total score) ranging from minus nine (-9), including zero (0), to plus nine (+9) Provision is made for circumstances when dyspnoea could not be rated - if reduction of activities, effort or functional impairment was caused by reasons other than respiratory A change of 1 unit in TDI is used as the criterion for a minimal meaningful improvement|Baseline and Week 24||||Score on a scale||Standard Error|Least Squares Mean
1379331|NCT01462942|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24||||Liters||Standard Error|Least Squares Mean
1379332|NCT01462942|Primary|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
1379333|NCT01462929|Secondary|Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value|||Liters||Standard Error|Least Squares Mean
1379334|NCT01462929|Primary|Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value|||Liters||Standard Error|Least Squares Mean
1379335|NCT01462877|Secondary|Change in Serum High Sensitivity C-reactive Protein|Blood tests|Baseline and up to 8 weeks after intervention|||||||
1379336|NCT01462877|Secondary|Change in Serum Creatinine|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of Creatinine change||Full Range|Median
1379337|NCT01462877|Secondary|Change in Serum Creatine Kinase|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of CK change||Full Range|Median
1379338|NCT01462877|Secondary|Change in Serum Aspartate Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of AST change||Full Range|Median
1379339|NCT01462877|Secondary|Change in Serum Alanine Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of ALT change||Full Range|Median
1379340|NCT01462877|Secondary|Change in Serum Apolipoprotein B|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of apoB change||Standard Deviation|Mean
1379341|NCT01462877|Secondary|Change in Serum Apolipoprotein A1|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of apoA1 change||Standard Deviation|Mean
1379342|NCT01462877|Secondary|Change in Serum Non-high-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of Non-HDL-C change||Standard Deviation|Mean
1379343|NCT01462877|Secondary|Change in Serum High-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of HDL-C change||Standard Deviation|Mean
1379344|NCT01462877|Secondary|Change in Serum Low-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of LDL-C change||Standard Deviation|Mean
1379345|NCT01462877|Secondary|Change in Serum Total Cholesterol|Blood tests|Baseline and up to 8 weeks after intervention|Full analysis set|||percentage of TC change||Standard Deviation|Mean
1379346|NCT01462877|Primary|Percentage of Triglyceride (TG) Change|Blood tests|Baseline and up to 8 weeks after intervention|Full Analysis Set|||percentage of TG change||Standard Deviation|Mean
1379347|NCT01462812|Primary|Headache Relief|The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.|120 Minutes|The full analysis dataset (FAD) will include all subjects who are randomized, receive study medication, and record at least one post-treatment assessment of pain severity. The treatment group assignment will be designated according to treatment received. The FAD will serve as the basis for the efficacy analyses.|||participants|||Number
1379738|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 6 (week 3)|||||||
1379348|NCT01462773|Secondary|Document Any Objective Anti-tumor Responses and Time to Tumor Progression That May Occur in Response to This Treatment Regimen.|"Measure levels of the cell cycle proteins p21 and p27 in PBMCs and tumor biopsies obtained pre-study and during week 4 of Cycle 1 (Day 26).~Conduct histologic evaluations of microvessel density, tumor apoptosis and lymphocytic infiltrates within tumor biopsies obtained pre- and post-study.~Measure plasma levels of bFGF and VEGF over the course of the study.~Monitor the effects of proteasome inhibition on the biological activity of IFN-α within immune cells by measuring Jak-STAT signal transduction in patient PBMCs."|up to 25 weeks||||patients|||Number
1379349|NCT01462773|Primary|Determine Dose Limiting Toxicities (DLTs) of VELCADE When Administered in Combination With IFN-α-2b to Patients With Metastatic Malignant Melanoma.|A standard method for the design of this study. Initially, three patients will be treated at a starting dose of VELCADE (1.0 mg/m2). If one of the three patients demonstrates a DLT, then an additional 3 patients will be treated at that dose level. If only one of the six show DLT, then the next cohort of three patients will be entered at the next dose level (1.3 mg/m2). If two or more of the six demonstrate DLT, no further patients will be treated at that dose level. The highest dose level at which less than 2 patients experienced DLT will be expanded to six patients.|up to 25 weeks or until disease progression||||toxicities|||Number
1379350|NCT01462695|Primary|Sustained Objective Response Rate|Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks.|Up to 5 years|One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.|||percentage of patients||95% Confidence Interval|Number
1379351|NCT01462565|Secondary|Number of Participants With Urine Pregnancy Test Positive|Urine samples were collected for urine pregnancy test. Urine samples were collected at up to the treatment follow up (1 week after Visit 3 [Week 4]). Number of participants with urine pregnancy test positive has been reported.|up to the treatment follow up (1 week after Visit 3 [Week 4])|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
1379352|NCT01462565|Secondary|Mean Oxygen Saturation in Blood Over Time|Pulse oximetry (oxygen saturation) was analyzed. Data for Pulse oximetry (oxygen saturation) was analyzed up to the treatment follow up (1 week after Visit 3 [Week 4]).|up to the treatment follow up (1 week after Visit 3 [Week 4])|ITT population. Only those participant available at the indicated time points were analyzed.|||Percentage of oxygen in blood||Standard Deviation|Mean
1379353|NCT01462565|Secondary|World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment|World Health Organization functional class was analyzed as class I, class II, class III and class IV. World Health Organization functional class was analyzed at Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4. The classed were defined as Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest, Class II: No symptoms at rest but uncomfortable and short of breath with normal activity, Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting and Class IV: Symptoms at rest and severe symptoms with any activity. Hence the severity increased from class I (better) to Class IV (worse).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Count of Participants
1379354|NCT01462565|Secondary|Breathlessness After 6MWD – Borg Dyspnoea Index (BDI)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from Baseline = score at observation minus score at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4|ITT population.|||Score on a scale||Standard Deviation|Mean
1379355|NCT01462565|Secondary|Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment|This assessment was a non-encouraged test that measures the distance walked for a duration of 6 minutes. Change from Baseline was calculated as value at observation minus value at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population.|||meters||Standard Deviation|Mean
1379356|NCT01462565|Secondary|Number of Participants With Abnormal Urinalysis|Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit).|Up to 1 week after Week 4 (Follow-up)|ITT population.|||Participants|||Count of Participants
1379357|NCT01462565|Secondary|Number of Participants With Abnormal Hematology|Values for hemoglobin, hematocrit, and platelet count were analyzed. Participants with abnormal values have been reported. The low and high value concern were as follows: hemoglobin (Males < 98, >180.0) (females <91, >161.0)grams per litre (g/L); hematocrit (Males < 32.0, >54.0) (females <29.0, >50.6) fraction (1); platelet count (< 100, > 500) gram international units per litre (gI/L).|Up to 1 week after Week 4 (Follow-up)|ITT population. Only those participant available at the indicated time points were analyzed.|||Participants|||Count of Participants
1379358|NCT01462565|Secondary|Number of Participants With Abnormal Clinical Chemistry|Abnormal clinical chemistry was analyzed as follows: serum alanine aminotransferase (ALT/SGPT) >= 3 x upper limit of normal (ULN) , aspartate aminotransferase (AST/SGOT) >= 3 x ULN , total bilirubin >= 34.2, creatinine >= 176.8.|Up to 1 week after Week 4 (Follow-up)|ITT population.|||Participants|||Count of Participants
1379359|NCT01462565|Secondary|Change From Baseline in Vital Signs at Week 4: Heart Rate|Summary mean change in heart rate measured in beats per minute (beats/min or BPM). Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4|ITT population.|||beats/min||Standard Deviation|Mean
1379360|NCT01462565|Secondary|Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure|Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)|ITT population.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1379362|NCT01462565|Secondary|Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, congenital anomaly/birth defect and medically significant and all events of possible drug-induced liver injury with hyperbilirubinaemia. Only treatment emergent AEs and SAEs were reported in this outcome measure. Specifically, this study reported 2 SAEs, but only 1 was categorized as treatment emergent.|Up to visit 3 (Week 4)|ITT population.|||Participants|||Count of Participants
1379363|NCT01462565|Primary|Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4|Dose titration requirement was assessed at the time of discharge. Change from Baseline was calculated as score at observation minus score at Baseline. Units- nanogram per kilogram per minute (ng/kg/min). Baseline was Visit 2 i.e . Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population.|||ng/kg/min||Standard Deviation|Mean
1379364|NCT01462565|Primary|Change From Baseline in Study Specific Participant Acceptance Survey|Study-specific questionnaire comprised the pre-defined15 questions which included activities of daily living assessment. Participants rated the question on a scale of 1 to 10, where 1 was do not agree and 10 was strongly agree. Change from Baseline was calculated as score at observation minus score at Baseline. Changes from Baseline was assessed for Questions 2 to 12. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).|ITT population.|||Score on a scale||Standard Deviation|Mean
1379365|NCT01462565|Primary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. Change from Baseline was calculated as score at observation minus score at baseline. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)|Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of epoprostenol sodium during the Run-in period (either currently marketed epoprostenol sodium or the study drug).|||Score on a scale||Standard Deviation|Mean
1379366|NCT01462435|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours||||units on a scale*hour||Standard Deviation|Mean
1379367|NCT01462435|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours||||units on a scale*hour||Standard Deviation|Mean
1379368|NCT01462435|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours||||units on a scale*hour||Standard Deviation|Mean
1379369|NCT01462435|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight.The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours||||units on a scale*hour||Standard Deviation|Mean
1379370|NCT01462435|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours||||mm*hour||Standard Deviation|Mean
1379371|NCT01462435|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours||||mm*hour||Standard Deviation|Mean
1379372|NCT01462435|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours||||mm*hour||Standard Deviation|Mean
1379373|NCT01462435|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48), ANCOVA Model.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent-to-Treat Population|||mm*hour||Standard Deviation|Mean
1379374|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose|At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.|24 Hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 24 hours post initial dose of study medication|||Participants|||Number
1379375|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose|At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.|6 hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 6 hours post initial dose of study medication.|||Participants|||Number
1379376|NCT01462370|Secondary|PR at Up to 24 Hours Following the Initial Dose|PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation at up to 24 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379377|NCT01462370|Secondary|PID at Up to 24 Hours Following the Initial Dose|PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation up to 24 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379378|NCT01462370|Secondary|PR at Up to 12 Hours Following the Initial Dose|PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation up to 12 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379379|NCT01462370|Secondary|PID at Up to 12 Hours Following the Initial Dose|PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation at up to 12 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379739|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 5 (week 2.5)|||||||
1379380|NCT01462370|Secondary|Number of Participants Using Rescue Medication 24 Hours After the Initial Dose|Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.|24 Hours|Due to the low number of participants requiring rescue medication use, the time to rescue medication use was not calculated.|||Participants|||Number
1379381|NCT01462370|Secondary|Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose|"Peak PR during the 6 hours post initial dose is defined as the maximum PR score~recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief."|Up to 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one Peak PR observation up to 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379382|NCT01462370|Secondary|Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose|Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had a PID observation at up to 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379383|NCT01462370|Secondary|Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose|The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.|Baseline and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had an observation at 6 hours post initial dose of study medication, and had a baseline measurement.|||Hours||95% Confidence Interval|Mean
1379384|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)|The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|24 hours|The population consisted of all participants that received at least one dose of study treatment had a GLOBAL24 observation at 24 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379385|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)|The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|6 hours|The population consisted of all participants that received at least one dose of study treatment and had a GLOBAL6 observation at 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379386|NCT01462370|Secondary|Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)|The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had at least one SPID6 observation up to 6 hours post initial dose of study medication, and had a baseline measurement.|||Score on a Scale||Standard Error|Least Squares Mean
1379387|NCT01462370|Primary|Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one TOPAR6 observation up to 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
1379388|NCT01462357|Secondary|Number of Subjects With Pregnancies|Note: No pregnancies were reported up to the Month 36 time point.|Throughout the study period (From Day 0 up to Month 36)|The Total Vaccinated cohort included all subjects with at least one study vaccine administered.|||Subjects|||Number
1379389|NCT01462357|Secondary|Number of Subjects Completing the Vaccination Schedule|The number of subjects who have completed the three-dose vaccination schedule in all groups.|Throughout the study period (From Day 0 up to Month 36)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379390|NCT01462357|Secondary|Number of Subjects Starting a Concomitant Medication|The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379391|NCT01462357|Secondary|Number of Subjects Starting a Concomitant Medication|The outcome presents the number of subjects starting any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.|During the 30-day (Days 0-29) post-vaccination period|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1392953|NCT01329978|Secondary|Change in HCV RNA at Week 2||Baseline (Day 1) to Week 2|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1379392|NCT01462357|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379393|NCT01462357|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379394|NCT01462357|Secondary|Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)|Note: Results beyond Month 24 will be updated when validated results become available.|From Day 0 to Month 36 (throughout the study period)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379395|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post-vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379396|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) following vaccination (across doses)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379397|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) following vaccination (across doses)|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379398|NCT01462357|Secondary|B-cell-mediated Immune Responses in the Sub-cohort for CMI|The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||B-cells/million cells||Inter-Quartile Range|Median
1379399|NCT01462357|Secondary|T-cell-mediated Immune Responses in the Sub-cohort for CMI|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L).|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||T-cells/million cells||Inter-Quartile Range|Median
1379400|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects|Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.|At Months 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Titers||95% Confidence Interval|Geometric Mean
1379401|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Subset of Subjects|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.|At Months 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed.|||Subjects|||Number
1379402|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers Assessed by PBNA in a Subset of Subjects|Anti-HPV 16/18 antibody titers were presented as geometric mean titers (GMT) and expressed in titers using the PBNA.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||Titer||95% Confidence Interval|Geometric Mean
1379403|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to ≥ 40 ED50) in the serum of subjects seronegative before vaccination in the primary study.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||Subjects|||Number
1379740|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 4 (week 2)|||||||
1379404|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (EL.U/mL) based on ELISA.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1379405|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination in the primary study.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||Subjects|||Number
1379406|NCT01462357|Primary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|"Anti-HPV 16/18 antibody concentrations were presented as geometric mean titers (GMT) and expressed in IU/mL.~Assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL respectively, after applying the conversion factor from EL.U/mL to IU/mL."|At Month 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||IU/mL||95% Confidence Interval|Geometric Mean
1379407|NCT01462357|Primary|Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA|"Seroconversion was defined as the appearance of antibodies [i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 3.1 and 3.2 international units per milliliter (IU/mL), respectively], in the serum of subjects who were seronegative before vaccination in the primary study.~The assay cut-offs used for analyses at Month 36 were modified to 3.1 and 3.2 IU/mL, after applying the conversion factor from EL.U/mL to IU/mL."|At Month 36|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||Subjects|||Number
1379408|NCT01462357|Primary|Anti-HPV-16/18 Antibody Concentrations Assessed by ELISA|Anti-HPV 16/18 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in ELISA units per milliliter (EL.U/mL) based on ELISA.|One month after the last dose of study vaccine (Month 7)|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1379409|NCT01462357|Primary|Number of Seroconverted Subjects for Anti-HPV-16/18, as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to 19 and 18 EL.U/mL, respectively), in the serum of subjects seronegative before vaccination in the primary study.|One month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis.|||Subjects|||Number
1379410|NCT01462344|Secondary|Percentage of Asthma Control Days Over the 6-month Study Treatment Period|An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population|||Percentage of asthma control days||Standard Error|Mean
1379411|NCT01462344|Secondary|Percentage of Rescue-free Days Over the 6-month Study Treatment Period|Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population|||Percentage of rescue-free days||Standard Error|Mean
1379412|NCT01462344|Secondary|Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period|An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.|From Day 1 up to 6 months|mITT Population|||Participants|||Number
1379413|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period|Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
1379414|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period|Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
1379415|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.|Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
1379429|NCT01462318|Primary|TP-DI Sub-study: Area-Under-the-Curve From Zero to Infinity (AUCinf) of Each Probe Drug|AUCinf of each of the following cytochrome P450 (CYP) isoenzyme substrates: midazolam (CYP3A), S-warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19). The AUC from zero to 12 hours (AUC0-12) was calculated for caffeine (CYP1A2).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||hr*ng/mL||Standard Deviation|Mean
1379416|NCT01462344|Primary|Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period|Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.|From Day 1 up to 6 months|mITT Population|||Participants|||Number
1379417|NCT01462344|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a >=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
1379418|NCT01462318|Secondary|TP-DI Sub-study: Omeprazole/Hydroxyomeprazole Concentration Ratio at 2 Hours Post-omeprazole Dosing||Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration) at 2 hours after probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter.|||ratio||Standard Deviation|Mean
1379419|NCT01462318|Secondary|TP-DI Sub-study: CL/F of Each Probe Drug|CL/F of each of the following CYP isoenzyme substrates: midazolam (CYP3A), warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||mL/hr||Standard Deviation|Mean
1379420|NCT01462318|Secondary|TP-DI Sub-study: Cmax of Each Probe Drug|Cmax of each of the following CYP isoenzyme substrates: midazolam (CYP3A), caffeine (CYP1A2), warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Substudy population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||ng/mL||Standard Deviation|Mean
1379421|NCT01462318|Secondary|Intensive PK Sub-study: Apparent Clearance (CL/F) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||L/day||Standard Deviation|Mean
1379422|NCT01462318|Secondary|Intensive PK Sub-study: Elimination Half-life (t½) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||day||Standard Deviation|Mean
1379423|NCT01462318|Secondary|Intensive PK Sub-study: Apparent Volume of Distribution (V/F) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||Liters||Standard Deviation|Mean
1379424|NCT01462318|Secondary|Intensive PK Sub-study: Minimum Concentrations (Cmin) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||mcg/mL||Standard Deviation|Mean
1379425|NCT01462318|Secondary|Intensive PK Sub-study: Area-Under-the-Curve From Start to End of the Dosing Interval (AUCtau) of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14, and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.|||day*mcg/mL||Standard Deviation|Mean
1379426|NCT01462318|Secondary|Intensive PK Sub-study: Time to Reach Maximum Concentration (Tmax) of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.|||day||Standard Deviation|Mean
1379427|NCT01462318|Secondary|Intensive PK Sub-study: Cmax of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.|||mcg/mL||Standard Deviation|Mean
1379428|NCT01462318|Primary|TP-DI Sub-study: Dextromethorphan to Dextrorphan Urine Concentration Ratio||Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and for 12 hours after probe-drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||ratio||Standard Deviation|Mean
1379430|NCT01462318|Primary|Number of Participants With Anti-DAC HYP Neutralizing Antibodies (NAbs): ECL ADA Assay|Participants with PB NAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).|Up to 44 weeks|Immunogenicity evaluable population: all participants in the main study population who received at least 1 dose of DAC HYP and had at least 1 post-study baseline immunogenicity assessment; n=participants with an assessment during the given period.|||participants|||Number
1379431|NCT01462318|Primary|Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay|Participants with post-baseline (PB) ADAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).|Up to 44 weeks|Immunogenicity evaluable population: all participants in the main study population who received at least 1 dose of DAC HYP and had at least 1 post-study baseline immunogenicity assessment; n=participants with an assessment during the given period.|||participants|||Number
1379432|NCT01462292|Secondary|Assessment of Functional Outcome by : Physician Assessment of Daily Living|This was conducted by the physician, which helped to assess and document observed changes in the participant by the physician reported by the participant or his family or caregiver. This was reported as any worsening and any improvement up to week 24.|Week 24 and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1379433|NCT01462292|Secondary|Assessment of Functional Outcome by : Functional Outcomes Survey During Treatment Period|This was conducted by the family or caregiver. This helped to document the observed changes in the participant’s functional outcome like the day to day activities; general health, mobility, and other general daily activities. The data for Week 24 has been reported as improved, not improved and not applicable.|Up to Week 24|ITT population. Only those participants available at that particular time points were analyzed.|||Participants|||Count of Participants
1379434|NCT01462292|Secondary|Number of Clinician Global Impression of Improvement (CGI-I) Responders|Single item question designed to provide a brief, stand-alone assessment of the clinician’s view of the participant’s global functioning after initiating a study medication, compared to their global functioning just prior to initiating treatment. Evaluated by an expert physician or evaluator familiar with DMD and who could make an expert clinical global judgement about severity of illness across various time points within context of clinical experience. The CGI-I reflects the clinician’s judgment about the total picture of the participant : the illness severity, the level of distress and other aspects of impairment, and impact of illness on functioning. The CGI-I is rated without regard to clinician’s belief that any clinical changes are or are not due to medication and without consideration of etiology of symptoms. It is measured on 7-point Likert scale (1 = ‘very much improved’, 2 = ‘much improved’, 4 = ‘no change’, 5 = ‘minimally worse’, 6 = ‘much worse’, 7 = ‘very much worse’).|Week 24 and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1379435|NCT01462292|Secondary|Number of Participants With Change From Baseline in Dystrophin Expression at Week 24 by Immunofluorescence Assay (IFA)|A muscle biopsy from the tibialis anterior muscle was taken to assess the expression of dystrophin. The muscle biopsy samples were collected by open biopsy or with the conchotome method according to standard hospital procedures for obtaining muscle biopsies from children. The minimum amount of muscle tissue required is a small piece of muscle of at least 0.5 x 0.5 x 0.5 centimeters. The muscle tissue was immediately frozen in liquid nitrogen-cooled 2-methylbutane and stored at -80°Celsius (C) or -70°C till shipment. In case of DMD participants , there is defect in the dystrophin producing gene or absence. Data for number of participants with change from baseline in dystrophin expression, was diagnosed using IFA and was categorized as strong increase, increase, and no change, decrease.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified timepoints were analyzed.|||Participants|||Count of Participants
1379436|NCT01462292|Secondary|Change From Baseline in Sniff Pressure Test at Week 24|This was one of the pulmonary function test which was a non-invasive procedure. It measured the inspiratory muscle strength by transdiaphragmatic (Pdi) and esophageal pressures (Pes) generated during volitional and nonvolitional maneuvers. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the specified time points were analyzed|||Centimeter of water||Standard Deviation|Mean
1379437|NCT01462292|Secondary|Change From Baseline in Peak Expiratory Flow at Week 24|The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. The peak expiratory flow was measured using spirometry. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified time points were analyzed|||Litres per minute||Standard Deviation|Mean
1379438|NCT01462292|Secondary|Change From Baseline in Peak Cough Flow at Week 24|The peak cough flow was conducted using a spirometer. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the indicated timepoints were used for analysis|||Litres per minute||Standard Deviation|Mean
1379439|NCT01462292|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 24|FVC is defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the indicated timepoints were used for analysis.|||Litres||Standard Deviation|Mean
1379440|NCT01462292|Secondary|Change From Baseline in Forced Expiratory Volume in the First Second of Exhalation (FEV1) at Week 24|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the indicated timepoints were used for analysis|||Litres||Standard Deviation|Mean
1379441|NCT01462292|Secondary|Change From Baseline in Creatinine Kinase Serum Concentrations|Creatine kinase (CK) is a muscle-specific enzyme; its level in plasma is considered to reflect the extent of muscle damage. In the blood samples drawn to this purpose, the plasma level of CK was measured. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||International units per liter||Standard Error|Least Squares Mean
1379442|NCT01462292|Secondary|Number of Participants With Accidental Falls During 6 Minute Walk Distance Test|The participants during the 6 minute walk distance were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in metersThe number of accident falls during the 6 minute walk distance were reported. Data is reported for the number of participants with accidental falls of 0, 1 and 2.|Baseline (Week 0), Week 24, Week 36 and Week 48|ITT Population. Only those participants available at the specified timepoints were analyzed|||Participants|||Number
1379443|NCT01462292|Secondary|Change From Baseline in the North Star Ambulatory Assessment (NSAA) Total Score|The NSAA was a functional scale devised from Hammersmith Scale of Motor Ability specifically for use in ambulant children with DMD. It consists of 17 activities graded 0 (unable to perform), 1 (performs with modifications), 2 (normal movement). The scale assessed activities that required for ambulatory activity and included items that were rarely achieved in untreated DMD (jump, hop, raise head) as well as items that are known to progressively deteriorate over time (stand from a chair, walk). A standardized manual is available within the SPM with specific instructions for grading. Video snaps used in training program to ensure evaluator reliability. The total score ranged from 0-34 where the highest score of 34 implies absence of symptoms and lower score implies more severe symptoms. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baselie (Week 0) and Week 24|ITT Population|||Scores on scale||Standard Error|Least Squares Mean
1379444|NCT01462292|Secondary|Change From Baseline in Muscle Strength Tests For-Knee Extensor, Knee Flexor, Hip Flexor, Elbow Flexor, Elbow Extensor, Shoulder Abductor at Week 24|The muscle strength was recorded by handheld myometry using a microFET2 myometer. Upper and lower limb proximal muscles were evaluated including knee flexors, knee extensors, elbow flexors, elbow extensors, shoulder abductors and hip flexors. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population.|||lbs||Standard Deviation|Mean
1379445|NCT01462292|Secondary|Change From Baseline in Muscle Strength Total Score at Week 24|The muscle strength was recorded by handheld myometry using a microFET2 myometer. Upper and lower limb proximal muscles were evaluated including knee flexors, knee extensors, elbow flexors, elbow extensors, shoulder abductors and hip flexors. Total score was calculated by summing up all individual scores. If data for any of the individual muscle strength tests was missing, the total score were set to missing for that visit. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the specified timepoints were analyzed|||Pounds (lbs)||Standard Error|Least Squares Mean
1379446|NCT01462292|Secondary|Change From Baseline in 10 Meter Walk/Run at Week 24|The participants during this assessment were asked to traverse marked 10-meter measured walkway as quickly as he safely can. Time was recorded to one tenth of a second with a stop watch from when his first foot crossed the start line until when the second foot crossed the finish line. How often the participant , touched the wall was to be noted. Care was taken to ensure that the participants were safe when completing this test. The assessor was allowed to walk nearby to provide ‘emergency’ help if needed, but must not support or provide manual assistance for the participant in any way. If the participant was unable to complete the 10-meter walk, the total distance was recorded. The participants were to perform the test in bare feet. No aids or orthoses were allowed. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population.|||Seconds||Standard Error|Least Squares Mean
1379447|NCT01462292|Secondary|Change From Baseline in 4 Stair Climb Ascent/Descent Time at Week 24|During this assessment, the participants were asked to ascend and descend four steps. The time for this was recorded with a stopwatch from the initiation of movement until the participant stands on the fourth step, (going up and going down separately). A flight of steps with handrail were used for this test. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population|||seconds||Standard Error|Least Squares Mean
1379448|NCT01462292|Secondary|Change From Baseline in Rise From Floor Time at Week 24|The rise from floor was assessed, when the participants stood from a standardized supine position as quickly as possible when told to go. Time was recorded with a stopwatch from the initiation of movement until the assumption of upright standing. No aids or orthoses were allowed. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population|||Seconds||Standard Error|Least Squares Mean
1379449|NCT01462292|Primary|Mean Change From Baseline in Muscle Function Using the 6 Minute Walking Distance|The participants during this assessment were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in meters. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|Intent to Treat (ITT) Population was defined as all participants who were randomized to the study, received at least one dose of study medication and have at least one post-Baseline efficacy assessment|||Meters||Standard Error|Least Squares Mean
1379523|NCT01461811|Secondary|Subjective Rating of End of Day Comfort|End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1379450|NCT01462279|Secondary|Improvement in Hemodynamics|Hemodynamics were collected in all patients but we did not evaluate change in hemodynamics over the 9 hour protocol of the study. Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error.|Baseline to Nine Hours|Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error.||||||
1379451|NCT01462279|Primary|Improvement in VO2|VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.|Baseline to 9 Hours||||ml/min||Standard Deviation|Mean
1379452|NCT01462266|Secondary|Time to Achieve the Fasting Glucose Target|Fasting glucose target 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). This analysis was the Kaplan-Meier estimated 50th percentile of time (days) to first attainment of target.|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication and had at least one post-randomization glycemic goal assessment.|||Days to first attainment of target||95% Confidence Interval|Median
1379453|NCT01462266|Secondary|Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study|The fasting glucose target was defined as 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L).|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication, and had at least one post-randomization glycemic goal assessment.|||Percentage of participants||95% Confidence Interval|Number
1379454|NCT01462266|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change in FPG (before breakfast) following 24 weeks of therapy (i.e., FPG at Week 24 minus FPG at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.|||mg/dL||95% Confidence Interval|Least Squares Mean
1379455|NCT01462266|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.|||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
1379456|NCT01462266|Primary|Change From Baseline in Daily Insulin Dose at Week 24|Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)|Baseline and Week 24|Full Analysis Set (FAS) population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.|||International Units (IU)||95% Confidence Interval|Least Squares Mean
1379457|NCT01462227|Secondary|Norepinephrine (pg/mL)|Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||pg/mL||Standard Deviation|Mean
1379458|NCT01462227|Secondary|Epinephrine (pg/mL)|Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||pg/mL||Standard Deviation|Mean
1379459|NCT01462227|Secondary|Cortisol (ug/dL)|Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||ug/dL||Standard Deviation|Mean
1379460|NCT01462227|Secondary|Glucagon (pg/mL)|Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||pg/mL||Standard Deviation|Mean
1379461|NCT01462227|Primary|Glucose Infusion Rate (mg/kg.Min)|The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||mg/kg.min||Standard Deviation|Mean
1379462|NCT01462227|Primary|Glucose (mg/dL)|Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||mg/dL||Standard Deviation|Mean
1379463|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||percentage of participants|||Number
1379464|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||percentage of participants|||Number
1379465|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population|DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
1379466|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24|DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis: All participants who had at least one measurement of effectiveness subsequent to the start of tocilizumab (RoActemra) treatment were included. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||score on a scale||Standard Deviation|Mean
1379467|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||score on a scale||Standard Deviation|Mean
1379468|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
1379469|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||score on a scale||Standard Deviation|Mean
1379470|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||score on a scale||Standard Deviation|Mean
1379471|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||centimeter||Standard Deviation|Mean
1379472|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24|Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||centimeter||Standard Deviation|Mean
1379741|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 3 (week 2)|||||||
1379473|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||hours||Standard Deviation|Mean
1379474|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
1379475|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||swollen joints||Standard Deviation|Mean
1379476|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, Week 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||swollen joints||Standard Deviation|Mean
1379477|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population|Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||unstandardized regression coefficient|||Number
1379478|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. Here, N=number of participants analyzed for this measure.|||unstandardized regression coefficient|||Number
1379479|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. N=number of participants analyzed for this measure.|||unstandardized regression coefficient|||Number
1379480|NCT01462162|Secondary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. Here, N=number of participants analyzed for this measure.|||unstandardized regression coefficient|||Number
1379481|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Serum Hemoglobin|The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants for each category.|||g/L||Standard Deviation|Mean
1379742|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 2 (week 1)|||||||
1379482|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, Week 24|Effectiveness analysis population.|||units on a scale||Standard Deviation|Mean
1379483|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 24|Effectiveness analysis population. Here, N=number of participants evaluable for this measure.|||unstandardized regression coefficient|||Number
1379484|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12|Effectiveness analysis population included all participants who had all measurements of effectiveness and had complete information of the FACIT questionnaire throughout the study. Here, Number of participants analyzed (N) = number of participants evaluable for this measure.|||unstandardized regression coefficient|||Number
1379485|NCT01462084|Secondary|Patient Comfort|Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied|Up to 1 month||||units on a scale||Standard Deviation|Mean
1379486|NCT01462084|Primary|Apnea Hypopnea Index (AHI)|Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV).|Up to 1 month||||events/hour||Standard Deviation|Mean
1379487|NCT01462045|Secondary|Cortisol|Change from baseline in serum cortisol levels at 8 weeks. Serum cortisol samples were collected at 8:00 Ante Meridian (AM). The changes are calculated from two time points as the values at 8 weeks minus the values at baseline.|baseline and 8 weeks||||μg/dl||Standard Deviation|Mean
1379488|NCT01462045|Primary|Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score|The PCL-C is a 17-item self-report instrument that measures the symptoms of PTSD. A total score, ranging from 17 to 85, is found by summing the scores of the 17 items. Higher values are considered to be a worse outcome. The inclusion criteria in the PTSD symptomatic group is a PCL-C total score of at least 28 with a score of 3 or higher on 1 or more items.To detect a reduction in PTSD symptom severity with a 2-sided 5% significance level and a power of 80%, the mean difference of PCL-C scores of 5.16 or greater requires a sample size of 20 participants for Exercise and Control groups, given an anticipated dropout rate of 10%. Data analyses are conducted using an a priori intention-to-treat approach. The analysis for the between-group differences of the intervention is conducted using t-tests comparing Exercise and Control groups at post-intervention. The analysis for the within-group difference is conducted using repeated measures ANOVA for both groups at baseline and week 8.|Baseline and 8 weeks|For Base Group, the values entered represent the mean value of the baseline PCL-C scores. The mean difference score for the Base Group is not available because the Base Group was assessed only at baseline.|||scores on a scale||Standard Deviation|Mean
1379489|NCT01461993|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3||||percentage of participants|||Number
1379490|NCT01461993|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)||Before Vaccination 1, 1 month after Vaccination 2, 3||||titer||95% Confidence Interval|Geometric Mean
1379491|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Vaccination 1, 1 month after Vaccination 2, 3||||percentage of participants|||Number
1379492|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||Before vaccination 1, 1 month after vaccination (Vac) 2, 3||||percentage of participants|||Number
1379493|NCT01461993|Secondary|Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants||Before vaccination 1||||percentage of participants|||Number
1379494|NCT01461993|Secondary|Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)||1 month after Vaccination 3||||percentage of participants|||Number
1379495|NCT01461993|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]||1 month after Vaccination 3||||titer||95% Confidence Interval|Geometric Mean
1379496|NCT01461993|Primary|Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens||1 month after Vaccination 3||||titer||95% Confidence Interval|Geometric Mean
1379743|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|26 week follow up|||||||
1379497|NCT01461980|Other Pre-specified|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.|||percentage of participants|||Number
1379498|NCT01461980|Other Pre-specified|Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.|||percentage of participants||95% Confidence Interval|Number
1379499|NCT01461980|Other Pre-specified|Immunogloblulin G (IgG) Measured by GMC|IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.|Before Vaccination 1, 1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1379500|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|||percentage of participants||95% Confidence Interval|Number
1379501|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|||percentage of participants||95% Confidence Interval|Number
1379502|NCT01461980|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|||titer||95% Confidence Interval|Geometric Mean
1379503|NCT01461980|Secondary|Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens|Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen.|||percentage of participants||95% Confidence Interval|Number
1379504|NCT01461980|Secondary|Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens|Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.|||percentage of participants||95% Confidence Interval|Number
1379505|NCT01461980|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3|Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|1 Month after Vaccination 3|Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1379506|NCT01461980|Primary|Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens|Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘N’ signifies participants with valid and determinate assay results for given strain for each group, respectively.|||titer||95% Confidence Interval|Geometric Mean
1379524|NCT01461811|Secondary|Subjective Rating of Insertion Comfort|Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1379507|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens|Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid and determinate assay results for given antigen.|||EU/mL||95% Confidence Interval|Geometric Mean
1379508|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens|Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, ‘number of participants analyzed’ signifies participants with valid and determinate assay results for given antigen.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1379509|NCT01461863|Secondary|Maternal BMI at 9 Months|Maternal BMI at 9 months|9 months||||kg/m^2||Standard Error|Median
1379510|NCT01461863|Primary|Infant Weight|Infant weight at 3 months|3 months||||kg||Standard Deviation|Mean
1379511|NCT01461824|Secondary|Percent Change in Total Hip BMD From Baseline to 48 Weeks|Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated.|Percent change from baseline to 48 weeks||||Percent change||Standard Deviation|Mean
1379512|NCT01461824|Primary|Proportion of Participants With >5% Weight Gain at 24 Weeks|Individual subjects will be assessed after their Week 24 visit.|Week 24||||Participants|||Count of Participants
1379513|NCT01461824|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks|Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.|Percent change from baseline to 48 Weeks||||percent change||Standard Deviation|Mean
1379514|NCT01461811|Secondary|Back Surface Debris/Deposits (None, Very Slight)|"Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
1379515|NCT01461811|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
1379516|NCT01461811|Secondary|Front Surface Wettability (None, Very Slight)|"Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
1379517|NCT01461811|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
1379518|NCT01461811|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
1379519|NCT01461811|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1379520|NCT01461811|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1379521|NCT01461811|Secondary|Subjective Rating of End of Day Dryness|End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1379522|NCT01461811|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1379525|NCT01461811|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of eyes|||Number
1379526|NCT01461733|Primary|Conversion From Atrial Fibrillation to Sinus Rhythm|Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.|From randomization to conversion or ICU discharge up to 100 months.||||participants|||Number
1379527|NCT01461707|Secondary|7-Day Physical Activity Recall|Change in mean energy expenditure|12 weeks||||kcal/day||Standard Deviation|Mean
1379528|NCT01461707|Primary|Physical Activity Monitor Measured Steps|Change in weekly mean steps per day|12 weeks||||step||Standard Deviation|Mean
1379529|NCT01461668|Primary|Proportion of Participants With MRSA Clearance|Proportion of participants with MRSA clearance at the end of the follow up period|47 days|The total number of participants analyzed include those that completed the study (through day 47).|||Participants|||Count of Participants
1379530|NCT01461655|Secondary|Investigator Global Assessment (IGA) of Disease Severity|"The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).~The outcome was the proportion of success (improvement of two grades of the IGA) from baseline to the end of treatment. “Success” is defined as improvement of two grades from the baseline assessment."|Baseline to End of treatment (4 weeks)||||participants|||Number
1379531|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 22|Baseline to Day 22||||percentage of change||Standard Deviation|Mean
1379532|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 15|Baseline to Day 15||||percentage of change||Standard Deviation|Mean
1379533|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total leasions count from baseline to day 8|Baseline to Day 8||||percentage of change||Standard Deviation|Mean
1379534|NCT01461655|Secondary|Total Lesions Count|Percentage change in total lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)||||percentage of change||Standard Deviation|Mean
1379535|NCT01461655|Secondary|Non-inflammatory Lesions Count|Percentage change in non-inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)||||percentage of change||Standard Deviation|Mean
1379536|NCT01461655|Primary|Percentage Change in Inflammatory Lesions From Baseline to End of Treatment|Percentage change in inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)||||percentage of change||Standard Deviation|Median
1379537|NCT01461551|Secondary|Intensive Care Unit Staying Days||participants will stay in intensive care unit after surgery, an expected average of 2 days|||||||
1379538|NCT01461551|Primary|Lymphocyte Count|Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.|1 day after surgery||||cells/nanoliter||Standard Deviation|Mean
1379539|NCT01461538|Secondary|Incidence of Anti-therapeutic Antibodies (ATA)|Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.|Up to approximately 3 years|Immunogenicity-evaluable set|||participants|||Number
1379540|NCT01461538|Secondary|Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available MMAE Ctrough results|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1379541|NCT01461538|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)||Up to approximately 3 years|All treated patients with available Cmax of MMAE results|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1379542|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available ADC Ctrough results|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1379543|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)||Up to approximately 3 years|All treated patients with available ADC Ceoi results|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1379544|NCT01461538|Secondary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category|Up to approximately 3 years|All treated patients|||participants|||Number
1379545|NCT01461538|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to approximately 3 years|All treated patients|||participants|||Number
1379546|NCT01461538|Secondary|Progression-Free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 2 years|All treated patients, excluding 3 patients without available response results|||months||95% Confidence Interval|Median
1379547|NCT01461538|Secondary|Duration of Complete Response by Kaplan-Meier Analysis|Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with CR|||months||Full Range|Median
1379548|NCT01461538|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with objective response (CR [+CRi; leukemia] + PR)|||months||Full Range|Median
1379549|NCT01461538|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population|||percentage of participants||95% Confidence Interval|Number
1379550|NCT01461538|Primary|Objective Response Rate (ORR) by Investigator|Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population|||percentage of participants||95% Confidence Interval|Number
1379551|NCT01461499|Secondary|Change in the Serum Insulin Level||baseline and 24 weeks|||||||
1379552|NCT01461499|Secondary|Change in the Plasma Renin Activity||baseline and 24 weeks|||||||
1379553|NCT01461499|Secondary|Change in the Urinary Angiotensinogen Level|Change in the urinaryurinary angiotensinogen level from the baseline|baseline and 24 weeks||||percentage of change UATGCR||95% Confidence Interval|Mean
1379554|NCT01461499|Primary|Reduction in Albuminuria|Change in the urinary albumin to creatinine ratio (UACR) from the baseline|baseline and 24 weeks||||percentage of UACR change||95% Confidence Interval|Mean
1379555|NCT01461473|Secondary|Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound|Mean relative flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter from baseline to the value that is obtained after the cuff deflation, divided by the baseline value and multiplied by 100) as measured by vascular ultrasound (VU) at the 6-month visit|6 months||||percent change||Standard Deviation|Mean
1379556|NCT01461473|Secondary|Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound|Mean absolute flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter [in millimeters] from baseline to the value that is obtained after the cuff deflation) as measured by vascular ultrasound (VU) at the 6-month visit|6 months||||mm||Standard Deviation|Mean
1379557|NCT01461473|Secondary|Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months|Ratio of NMAP to daytime mean arterial pressure, expressed as a percentage at the 6 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.|6 months|Two participants in the PAP arm and 1 participant in the OA arm did not have sufficient daytime MAP data to calculate the ratio of NMAP to daytime MAP at 6 months|||percentage of NMAP to daytime MAP||Standard Deviation|Mean
1379558|NCT01461473|Secondary|Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months|Ratio of NMAP to mean daytime arterial pressure, expressed as a percentage at the 2 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.|2 months|31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.|||percentage of NMAP to daytime MAP||Standard Deviation|Mean
1379559|NCT01461473|Secondary|Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months|Nocturnal mean arterial blood pressure as recorded by 24-hour ambulatory blood pressure monitoring after approximately 6 months of treatment|6 months||||mmHg||Standard Deviation|Mean
1379560|NCT01461473|Primary|Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months|Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment|2 months|31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.|||mmHg||Standard Deviation|Mean
1379561|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Pain Imaginable.~The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.|||mm||Standard Error|Least Squares Mean
1379569|NCT01461096|Secondary|Number of Participants With Anal Cytological Abnormality Occurrences|Anal cytologic abnormalities include: atypical squamous cells undetermined significance (ASCUS), atypical squamous cells favor high-grade SIL/squamous cell carcinoma (ASC-H), low-grade squamous intraepithelial lesion/mild dysplasia/HPV (LSIL), or high-grade SIL/moderate dysplasia to severe dysplasia/carcinoma in situ/features of invasion (HSIL).|At baseline, Week 52, Week 104 and Week 156|mITT population including all participants who received at least one dose of vaccine.|||Participants|||Count of Participants
1379744|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|12 week follow up|||||||
1379562|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.|||mm||Standard Error|Least Squares Mean
1379563|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1379564|NCT01461369|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1379565|NCT01461369|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1379566|NCT01461369|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
1379567|NCT01461096|Secondary|Time to First New Persistent Oral HPV Infection of Vaccine Types Detected From Oral Rinse|"The outcome for this evaluation was time to the first new persistent infection of any of oral HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive oral HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary endpoint if they were PCR negative for at least one of the four vaccine HPV types at baseline.~NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, for up to 4 years|mITT population wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.|||Years||95.1% Confidence Interval|Number
1379568|NCT01461096|Secondary|Number of Participants With Grade 3 or 4 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine, as Determined by the Local Investigator|To grade diagnoses, signs and symptoms, and laboratory results, sites must refer to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, august 2009).|From baseline to participant's last study visit, for up to 4 years|mITT population including all participants who received at least one dose of vaccine.|||Participants|||Count of Participants
1379745|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|5 weeks (or after treatment session 10)|||||||
1379570|NCT01461096|Secondary|Number of Participants With Biopsy-proven High-grade Anal Intraepithelial Neoplasia (HGAIN) Occurrences and Reoccurrences After Week 52|HGAIN was defined as AIN2 (moderate dysplasia, with no mention of AIN grade III), AIN3 (severe dysplasia, carcinoma in-situ, or AIN grade II/III), high grade AIN not specified, or adenocarcinoma in situ found in the intra-anal or perianal region.|From Week 52 to participant's last study visit, for up to 4 years|mITT population including all participants who received at least one dose of vaccine.|||Participants|||Count of Participants
1379571|NCT01461096|Primary|Time to the First New Persistent Infection of HPV 6, 11, 16, or 18|"The outcome for this evaluation was time to the first new persistent infection of any of HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive anal HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary outcome if they were PCR negative for at least one of the four vaccine HPV types at baseline.~NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, for up to 4 years|The efficacy analysis for persistent anal HPV employed a modified intent-to-treat (mITT) approach wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.|||Years||95.1% Confidence Interval|Number
1379572|NCT01461057|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|From randomization of first participant to end of study (approximately 6 years)|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
1379573|NCT01461057|Primary|Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)||Day 43|The primary pharmacokinetic (PK) analysis population consisted of all participants with a measurable PK samples on Day 43.|||percentage of participants||95% Confidence Interval|Number
1379574|NCT01461044|Secondary|Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||percentage of participants|||Number
1379575|NCT01461044|Secondary|Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were available for this evaluation.|||percentage of participants|||Number
1379576|NCT01461044|Primary|Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379577|NCT01461044|Primary|Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379578|NCT01461044|Primary|Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression|The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with < or >=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379579|NCT01461044|Primary|Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression|MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379580|NCT01461044|Primary|Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379581|NCT01461044|Primary|Percentage of Participants With HR Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379582|NCT01461044|Primary|Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379583|NCT01461044|Primary|Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379584|NCT01461044|Primary|Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
1379585|NCT01461044|Primary|Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.|||percentage of participants||95% Confidence Interval|Number
1379586|NCT01461044|Primary|Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression|Percentage of participants that reported metastatic disease in less than or equal to (<=) 3 sites or greater than (>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of metastatic sites.|||percentage of participants||95% Confidence Interval|Number
1379587|NCT01461044|Secondary|Percentage of Participants With Reasons for Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were definitive discontinued.|||percentage of participants|||Number
1379588|NCT01461044|Secondary|Percentage of Participants With Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.|||percentage of participants|||Number
1379589|NCT01461044|Secondary|Percentage of Participants With Reasons for Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.|||percentage of participants|||Number
1379590|NCT01461044|Secondary|Percentage of Participants With Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.|||percentage of participants|||Number
1379591|NCT01461044|Secondary|Duration of Bevacizumab as First Line Treatment||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||months||Full Range|Median
1379592|NCT01461044|Primary|Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression|Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.|||percentage of participants||95% Confidence Interval|Number
1379593|NCT01461044|Primary|Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BRCA mutation.|||percentage of participants|||Number
1379594|NCT01461044|Primary|Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BMI which was measured in kg/m^2.|||kg/m^2||Standard Deviation|Mean
1379595|NCT01461044|Primary|Mean Height at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of height.|||centimeters||Standard Deviation|Mean
1379596|NCT01461044|Primary|Mean Body Weight at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of body weight.|||kilograms||Standard Deviation|Mean
1379597|NCT01461044|Primary|Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of ECOG PS.|||percentage of participants|||Number
1379598|NCT01461044|Primary|Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression|Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of menopausal status.|||percentage of participants|||Number
1379599|NCT01461044|Primary|Mean Age at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.|||years||Standard Deviation|Mean
1379600|NCT01461044|Primary|Disease-Free Interval|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.|||months||Full Range|Median
1379601|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1379602|NCT01461044|Secondary|Overall Survival (OS)|OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||months||95% Confidence Interval|Median
1379603|NCT01461044|Secondary|Percentage of Participants With Death|Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||percentage of participants|||Number
1379604|NCT01461044|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.|||months||95% Confidence Interval|Median
1379605|NCT01461044|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.|||months||95% Confidence Interval|Median
1379643|NCT01460342|Secondary|Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks|The CGI-I measured the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.|||participants|||Number
1379606|NCT01461044|Secondary|Percentage of Participants With Disease Progression or Death|"Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment."|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population.|||percentage of participants|||Number
1379607|NCT01461044|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants||95% Confidence Interval|Number
1379608|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1379609|NCT01460940|Secondary|Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat|Determined from the date of start of therapy to death from any cause or censored at the last date the patient is known to be alive|3-5 years||||months||95% Confidence Interval|Median
1379610|NCT01460940|Secondary|Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma.|Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0|up to 24 months|Grade 3-4 toxicities|||percentage of patients|||Number
1379611|NCT01460940|Primary|Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)|Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.|up to 24 months||||percentage of patients|||Number
1379612|NCT01460927|Primary|Fitzpatrick Classification of Wrinkling and Degree of Elastosis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri orbital wrinkles.~Observing changes to the surface by visual and photographic analysis based on the score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis. (Lasers Surg Med 2003;33(4):232 42)~Score Wrinkling & Degree of Elastosis 1-3 Fine wrinkles (rhytides) and Mild Elastosis (fine textural changes with subtly accentuated skin lines) 4-6 Fine to moderate depth wrinkles, moderate number of lines and Moderate Elastosis (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia)"|Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU|Per protocol|||Fitzpatrick Classification Scale||Full Range|Mean
1379613|NCT01460732|Secondary|Dippers Defined by ABPM and HBPM-Nocturnal|As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.|2 weeks|All patients who had their Daytime and Nocturnal BP assessed by both methods.|||percentage of patients|||Number
1379614|NCT01460732|Primary|Asleep Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks||||mmHg||Standard Deviation|Mean
1379615|NCT01460732|Primary|Asleep Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks||||mmHg||Standard Deviation|Mean
1379616|NCT01460732|Primary|Awake Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks||||mmHg||Standard Deviation|Mean
1379617|NCT01460732|Primary|Awake Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks||||mmHg||Standard Deviation|Mean
1379618|NCT01460732|Primary|Asleep Diastolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
1379619|NCT01460732|Primary|Asleep Systolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
1379620|NCT01460732|Primary|Awake Diastolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
1379621|NCT01460732|Primary|Awake Systolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
1379622|NCT01460628|Secondary|Brown Attention Deficit Disorder Scale (BADDS)|This is a normed and validated measure of ADHD-related executive function impairments. The clinician administered scale measures five clusters of executive function including 1) organizing and activating for work, 2) sustaining attention and concentration, 3) sustaining alertness, effort, and processing speed, 4) managing affective interference, and 5) using working memory and accessing recall. The frequency and severity of each of the 40 items is rated on a scale of 0 to 3, with the total scores ranging from 0-120 and higher scores indicating worse symptoms.|4 weeks||||units on a scale||Inter-Quartile Range|Median
1379623|NCT01460628|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The PHQ-9 is the self-administered form of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used instrument designed to screen for psychiatric illnesses in primary-care settings. This 9-item instrument assesses mood, depressive symptoms, and suicidal ideation. The range of total scores is 0-27 with higher scores indicating worse symptoms. Generally, scores 5-9 indicate mild depression, 10-14 indicate moderate depression, and 15+ indicate moderately severe or severe depression.|4 weeks||||units on a scale||Inter-Quartile Range|Median
1379624|NCT01460628|Secondary|Symptom Checklist-10 Anxiety|The SCL-10 anxiety subscale, developed from the refinement of the Hopkins Symptom Checklist (HSCL), consists of 10 questions focused on how much discomfort symptoms of anxiety (e.g. “nervousness or shaking inside”) have caused in the past two weeks. Each question is answered on a scale from 0-4, and answers are averaged for a total score between 0-4 with higher scores indicating more anxiety.|4 weeks||||units on a scale||Inter-Quartile Range|Median
1379625|NCT01460628|Secondary|Hot Flash Frequency (24-hr Period)|The Daily Vasomotor Symptom Diary consists of a 7-day scale on which the subject records the total number of hot flushes they experience on a daily basis. Weekly averages for a 24-hour period are calculated.|4 weeks||||# of hot flashes||Inter-Quartile Range|Median
1379626|NCT01460628|Secondary|Epsworth Sleepiness Scale (ESS)|This self-report scale is widely used as a subjective measure of sleepiness. This 8 item instrument yields a total score ranging from 0-24 with higher scores indicating worse symptoms.|4 weeks||||units on a scale||Inter-Quartile Range|Median
1379627|NCT01460628|Primary|Brief Fatigue Inventory (BFI)|This is a widely used self-report instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. This 9 item instrument yields a global fatigue score ranging from 0-10 with higher scores indicating worse symptoms. .|4 weeks||||units on a scale||Inter-Quartile Range|Median
1379628|NCT01460628|Primary|Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale|This is a widely used self-report instrument to determine differences in quality of life among menopausal women and to measure changes in their quality of life over time. Four domain scores are calculated from the 29-item instrument. The physical domain subscale has 16 questions and a range from 0-8 with higher scores indicating worse symptoms.|4 weeks||||units on a scale||Inter-Quartile Range|Median
1379629|NCT01460446|Secondary|The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score|"The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) contains 6 items which can be scored from 0=‘very bad’ to 6=‘very good’. The total score is the sum of the scores of the 6 items and ranges from 0 to 36. A higher score indicates more satisfaction. This questionnaire was administered at Baseline only.~The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3=‘much worse now’ to 3=‘much better now’). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only."|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Units on a scale||Standard Deviation|Mean
1379630|NCT01460446|Secondary|Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24|The Hypoglycemia Fear Survey-II (HFS-II) contains 33 items (15 items regarding behavior and 18 items regarding worry) which can be rated from 0=‘never’ to 4=‘always’). The total HFS-II score ranges from 0 to 132 with a higher score indicating more fear. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.|||Units on a scale||Standard Deviation|Mean
1379631|NCT01460446|Secondary|Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24|The Problem Area in Diabetes (PAID) scale contains 20 items which can be rated from 0=‘not a problem’ to 4=‘serious problem’. The total PAID scale score ranges from 0 to 80 with a higher score indicating more diabetes-related problems. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.|||Units on a scale||Standard Deviation|Mean
1379632|NCT01460446|Secondary|Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24|The Major Depression Disorder (MDD) scale is derived from the Patient Health Questionnaire depression scale (PHQ-8) and was used to categorize participants in regard to the severity of their depression. There are 5 categories on the MDD scale: None, mild, moderate, moderately severe, and severe. The category for each participant is determined from their PHQ-8 score. A total PHQ-8 score of 0 to 4 represents no significant depressive symptoms. A total PHQ-8 score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. A higher score indicates more depression.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Participants|||Number
1379633|NCT01460446|Secondary|Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24|The Patient Health Questionnaire depression scale (PHQ-8) contains 8 items which can be rated from 0='not at all' to 3='nearly every day'. The total PHQ-8 score is the sum of the responses to the 8 items and ranges from 0 to 24. A lower score indicates less depression. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who had data available for analysis.|||Units on a scale||Standard Deviation|Mean
1379644|NCT01460342|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks|The PGI-I scale measured the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.|||participants|||Number
1379634|NCT01460446|Secondary|Change in Carbohydrate Counting Accuracy From Baseline to Week 24|Participants were asked to assess the carbohydrate content (grams) of 10 standardized meals by using a set of Dose Adjustment for Normal Eating (DAFNE) plates, which provide standardized photographs of meals with known carbohydrate values. The mean meal error (MME), an indicator of accuracy, and mean meal absolute error (MMAE), an indicator of variability were calculated from their responses. The MME is defined as the mean of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. A negative MME indicates an underestimation and a positive MME indicates an overestimation of the actual carbohydrate content. The MMAE is defined as the mean of the absolute value of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. The MMAE is ≥ 0 with a lower value indicating a better ability to estimate the actual carbohydrate content.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.|||Grams||Standard Deviation|Mean
1379635|NCT01460446|Secondary|Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study|Participants using the Aviva Nano blood glucose meter received individualized advice in how to use their insulin:carbohydrate ratio (I:CHO) and insulin sensitivity factor (ISF) values to determine their insulin dose. The I:CHO ratio advice was considered to have been used correctly if the meal bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant’s total carbohydrate intake and the I:CHO ratio. The ISF advice was considered to have been correctly used if the correction bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant’s blood glucose target, current blood glucose value, and the ISF.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study. Results are only reported for participants using the Aviva Nano blood glucose meter who had data available for analysis.|||Number of advices per day||Standard Deviation|Mean
1379636|NCT01460446|Secondary|Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.|||Number of advices modified per day||Standard Deviation|Mean
1379637|NCT01460446|Secondary|Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.|||Percentage of opportunities||Standard Deviation|Mean
1379638|NCT01460446|Secondary|Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24|Approximately half of the investigational sites monitored glucose levels in participants enrolled in this study using the DexCom Seven® Plus Continuous Glucose Monitoring device. The device provides glucose measurements every 5 minutes for up to 7 days. The system contains a sensor, transmitter, and receiver. The sensor is a flexible round wire that goes under the skin to read glucose levels. The transmitter snaps into the sensor and wirelessly sends glucose readings to the receiver. Data was obtained from approximately one-third of participants and was used to calculate MAGE. Data were collected in the 3 days prior to Baseline and the Week 24 visit. The standard deviation of the blood glucose measurements in each 3-day period was calculated. For each glucose measurement, the difference from the previous reading was calculated. Absolute differences smaller than the standard deviation were discarded. MAGE is the mean of the remaining difference scores.|3 days prior to Baseline to Week 24|Intent-to-treat population: All randomized participants with continuous glucose monitoring data at Baseline and at Week 24 who completed the study.|||mg/dL||Standard Deviation|Mean
1379639|NCT01460446|Secondary|Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24|A symptomatic hypoglycemic episode was defined as an event with symptoms consistent with hypoglycemia which was confirmed by a blood glucose reading < 70 mg/dL (3.9 mmol/L). Symptoms might include but were not limited to sweating, dizziness, lightheadedness, tremors, nervousness, hunger, headaches, and weakness or tiredness.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Episodes per year||Standard Deviation|Mean
1379640|NCT01460446|Secondary|Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24|Participants measured their blood glucose at least 3-4 times daily throughout the study. The mean blood glucose level was calculated for each 3-day period from Baseline to Week 24 and the percentage of 3-day blood glucose levels with the target range of 70-180 mg/dL (3.9-10 mmol/L) was calculated for the 2 reporting periods of Screening to Baseline and Week 23 to Week 24.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Percentage of measurements||Standard Deviation|Mean
1379641|NCT01460446|Primary|Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24|HbA1C was measured in blood samples at a central laboratory.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Percentage||Standard Deviation|Mean
1379642|NCT01460342|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) Score at 2 Weeks|The mIPSS Total Score was the sum of Questions 1 through 7 in the mIPSS questionnaire, which was a modified version of the IPSS questionnaire. Questions about the participant's urination experiences and prostate symptoms in the IPSS questionnaire were modified to obtain responses based on time since the last visit rather than during the last month. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an mIPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the analysis of covariance (ANCOVA) model with treatment, prior alpha-blocker use (yes/no), and country (Japan/Korea) as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
1379746|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|2.5 weeks (or after treatment session 5)|||||||
1379645|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|"The IPSS QoL Index assessed the participant's response to the following question, If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options were 0 (Delighted), 1 (Pleased), 2 (Mostly satisfied), 3 (Mixed, about equally satisfied and dissatisfied), 4 (Mostly dissatisfied), 5 (Unhappy), and 6 (Terrible), for a QoL Index Score that ranged from 0 to 6. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates."|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
1379646|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|The IPSS Voiding (Obstructive) Subscore was the sum of Questions 1, 3, 5, and 6 in the IPSS questionnaire. Each question was scored from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms) for an IPSS Voiding (Obstructive) Subscore that ranged from 0 to 20; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
1379647|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|The IPSS Storage (Irritative) Subscore was the sum of Questions 2, 4, and 7 in the IPSS questionnaire. Each question was scored from 0 (no irritative symptoms) to 5 (frequent irritative symptoms) for an IPSS Storage (Irritative) Subscore that ranged from 0 to 15; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
1379648|NCT01460342|Secondary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS)|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
1379649|NCT01460342|Primary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
1379650|NCT01460303|Secondary|Composite Satisfaction Score (CSS)|"The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score.~Total Pain (0 none, 10 worst)~Total Catheter Related Pain Range Scale (0 none, 10 worst)~Ease of catheter use (0 easy, 10 difficult)~Feeling of frustration (0 none, 10 very much)~Limited social activities (0 none, 10 very much) All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative Questionnaire was completed by the subject one time at that appointment."|5-10 days postoperatively||||units on a scale||Standard Deviation|Mean
1379651|NCT01460303|Primary|Total Catheter Related Pain|Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.|5-10 days postoperatively||||units on a scale||Standard Deviation|Median
1379652|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Recognition Discrimination Index appears in this entry below"|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||number of items||Standard Deviation|Mean
1379726|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 5 (week 2.5)|||||||
1379653|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Retention scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||percentage of items||Standard Deviation|Mean
1379654|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Delayed recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||correctly recalled items||Standard Deviation|Mean
1379655|NCT01460290|Secondary|Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS)|The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. The highest possible total score is 40. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
1379656|NCT01460290|Secondary|Barnes Drug-induced Akathisia Rating Scale (BARS)|This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
1379657|NCT01460290|Secondary|World Health Organization Disability Assessment Scale (WHO-DAS)|The WHO-DAS II is used to assess patients for difficulties that they experience due to health conditions. Six subscales are represented which cover the following domains: Getting Around (range 1-10), Self Care (range 1-10), Life Activities (range 1-20), Understand/Communicate (range 1-10), Participation in Society (range 1-10), and Getting Along with People (range 1-10). Lower scores represent more positive outcomes, while higher scores represent worse outcomes. Total summary scores were not computed for our analyses and is optional for the measure.|12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
1379658|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS)|The DRS contains items that evaluate cognitive function across 5 subscales: attention, initiation/perseveration, construction, conceptualization, and memory. Subscale raw score ranges are: attention (0-37), initiation/perseveration (0-37), construction (0-6), conceptualization (0-39), and memory (0-25). Raw subscale scores are added for a total raw score with range 0-144. For each raw subscale score, scaled scores are looked up from a battery of 13 tables. Age of the participant determines which table is to be used. Total raw subscale score also has its own scaled score in the tables. In addition to use in determining scaled scores for each of the subscales, these tables are used to look up the scaled score for the total raw score. The tables are contained in the article Robust and Expanded Norms for the Dementia Rating Scale (Pedraza, Lucas, et al. 2010); Archives of Clinical Neuropsychology 25; 347-358. Higher scores, raw and scaled, indicate better cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||units on a scale||Standard Deviation|Mean
1379659|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-36). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Total recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||correctly recalled items||Standard Deviation|Mean
1379660|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Trail Making Test|The Trails test is a measure of cognitive functioning. The measure consists of two parts: A and B. In part A, participants are asked to draw a trail connecting a series of numbers in sequential order. In Part B, participants are asked to draw a trail connecting a combination of letters and numbers. The time taken to complete each task is noted as the score (e.g., 78 seconds). For Trails A, there is no upper limit on the score, as subjects are given as much time as is needed for them to complete the task. Higher scores indicate poorer cognitive functioning. In Trails B, the task is timed with an upper limit of five minutes. If, at four minutes, it is determined that the subject will not likely complete the task in the time allotted, then the task can be called off. Higher scores indicate poorer cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||seconds||Standard Deviation|Mean
1379661|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Stroop Task|The Stroop evaluates patients for cognitive functioning. Patients are to read words aloud or name colors as quickly as possible in a 45-second period. The measure contains three tasks, each associated with a subscale as follows: Word, Color, and Color-Word. Each subscale contains 100 items. The raw score range for each of the subscales is 0-100. Each raw subscale score is converted to a T-Score. The possible T-Score range for the Word subscale is 15 to 85. The possible T-Score range for the Color subscale is 8 to 92. The possible T-Score range for the Color-Word subscale is 3 to 98. Higher scores on the subscales indicate better cognitive functioning. Subscales are scored independently and are not added to produce a total score.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||T-Score||Standard Deviation|Mean
1379662|NCT01460290|Secondary|Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
1379663|NCT01460290|Secondary|Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline MADRS score of 16 or greater were analyzed. LOCF|||units on a scale||Standard Deviation|Mean
1379664|NCT01460290|Secondary|Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
1379665|NCT01460290|Secondary|Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
1379666|NCT01460290|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)|"The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.~The CGI-BP has three scores - Mania Severity, Depression Severity, and Overall Bipolar Illness Severity."|Baseline and 12 weeks|Intention To Treat (ITT) and LOCF|||units on a scale||Standard Deviation|Mean
1379667|NCT01460290|Primary|Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline YMRS score of 12 or greater were analyzed. LOCF|||units on a scale||Standard Deviation|Mean
1379668|NCT01460290|Primary|Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with baseline HAM-D score of 8 or greater were analyzed. Last Observational Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1379669|NCT01460225|Primary|Gastric Emptying|gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)|Day 1 and Day 7||||percent meal retention||Standard Deviation|Mean
1379670|NCT01460160|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|The number of participants with grade 3-4 serum chemistry laboratory abnormalities was presented for each arm.|Approximately 3 years|All treated participants|||participants|||Number
1379671|NCT01460160|Secondary|Number of Participants With Grade 3-4 Kidney Function Abnormalities|The number of participants experiencing Grade 3 or 4 kidney function laboratory abnormalities was reported by arm.|Approximately 3 years|All treated participants|||participants|||Number
1379672|NCT01460160|Secondary|Number of Participants With Grade 3-4 Liver Function Laboratory Abnormalities.|The number of participants experiencing Grade 3 or 4 liver function laboratory abnormalities was reported by arm.|Approximately 3 years|All treated participants|||participants|||Number
1379673|NCT01460160|Secondary|Number of Participants With Grade 3-4 Hematology Laboratory Abnormalities.|The number of participants experiencing Grade 3 or 4 hematology laboratory abnormalities was reported by arm.|Approximately 3 years|All treated participants|||participants|||Number
1379674|NCT01460160|Secondary|Number of Participants With BCR-ABL Mutations at Time of Disease Progression|The number of Ph+ ALL participants with BCR-ABL Mutations at Disease Progression or Relapse was reported for each arm.|Approximately 3 years|Treated Ph+ ALL participants with mutation data at both baseline and disease progression|||participants|||Number
1379675|NCT01460160|Secondary|Number of Participants With AEs or Drug Related Death|The number of participants with any AE or with study drug-related death was reported for each arm.|Approximately 3 years|All treated participants|||Participants|||Number
1379676|NCT01460160|Secondary|Percentage of Participants With Minimal Residual Disease Based on Ig/TCR Method|The number of participants with MRD at the end of the Induction 1B and Consolidation periods was divided by the number of treated participants and expressed as a percentage.|3 years|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
1379677|NCT01460160|Secondary|Complete Remission Rate|CR rate is defined as the proportion of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease, and expressed as a percentage. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.|3 years|All treated participants|||Percentage of Partcipants|||Number
1379678|NCT01460160|Secondary|Overall Survival (K-M Estimate) Rate at 3 Years|Overall survival is defined as time from the first day of dasatinib treatment until the time of death. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The rate of OS at 3 years was expressed as a percentage of all treated participants.|3 years|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
1379727|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 4 (week 2)|||||||
1379747|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|26 Week follow up|||||||
1379679|NCT01460160|Secondary|Percentage of Participants With 3-year EFS Rate (K-M Estimate)|Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.|3 years|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
1379680|NCT01460160|Primary|Percentage of Participants With 3-year Event-free Survival (EFS)|"EFS is defined as the time from the starting date of dasatinib until an event. In the primary analysis, the 3-year EFS response rate is defined as the number of participants without event after 3 years since the start of dasatinib divided by the number of treated participants and expressed as a percentage. Events for EFS are defined as ANY first one of the following:~Lack of complete response in bone marrow~Relapse at any site~Development of second malignant neoplasm~Death from any cause"|3 years|All treated participants|||Percentage of Participants||90% Confidence Interval|Number
1379681|NCT01459913|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 48|Safety set included all subjects who received at least 1 dose of study drug.|||participants|||Number
1379682|NCT01459913|Secondary|Number of Subjects With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 4 and Week 12|FA Set.|||participants|||Number
1379683|NCT01459913|Secondary|Number of Subjects With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 4|FA Set.|||participants|||Number
1379684|NCT01459913|Secondary|Percentage of Subjects With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.|Baseline up to Week 48|FA Set.|||percentage of participants|||Number
1379685|NCT01459913|Secondary|Percentage of Subjects With Viral Relapse|Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up|FA Set.|||percentage of participants|||Number
1379686|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)|SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|Week 72|FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to ‘Study Terminated by the Sponsor’ are excluded from this analysis.|||percentage of participants|||Number
1379687|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|24 weeks after last planned dose of study drug (up to Week 48)|FA Set.|||percentage of participants|||Number
1379688|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)|SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|4 weeks after last planned dose of study drug (up to Week 28)|FA Set.|||percentage of participants|||Number
1379728|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 3 (week 2)|||||||
1379689|NCT01459913|Primary|Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.|12 weeks after last planned dose of study drug (up to Week 36)|Full Analysis (FA) Set.|||percentage of participants|||Number
1379690|NCT01459796|Secondary|Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)|Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.|Day 1 to Day 364 (Week 52)|Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).|||percentage of participants|||Number
1379691|NCT01459796|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure.|Day 1 to Day 364 (Week 52)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
1379692|NCT01459796|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure.|Day 1 to Day 364 (Week 52)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
1379693|NCT01459796|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure.|Day 1 to Day 168 (Week 24)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
1379694|NCT01459796|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure.|Day 1 to Day 168 (Week 24)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
1379695|NCT01459796|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Day 1 to Day 392 (Week 56)|Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).|||percentage of participants|||Number
1379696|NCT01459783|Secondary|Change in Process Measures of Dementia Care Quality at 6 and 12 Months|The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.|0, 6 and 12 months|||||||
1379697|NCT01459783|Secondary|Change in Care Recipient Quality of Life at 6 and 12 Months|The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.|0, 6 and 12 months|||||||
1379698|NCT01459783|Secondary|Change in Caregiver Quality of Life at 6 and 12 Months|The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.|0, 6 and 12 months|||||||
1379699|NCT01459783|Secondary|Change in Caregiver Depression at 6 and 12 Months|"The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks. The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders. It covers each of the 9 DSM-IV depression criteria scoring them as 0 (not at all) to 3 (nearly every day)."|0, 6 and 12 months|||||||
1379700|NCT01459783|Primary|Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months|The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues. The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week. Higher RMBPC scores mean worse memory/behavior problems. The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.|0, 6 and 12 months||||units on a scale||Standard Deviation|Mean
1379701|NCT01459783|Primary|Change in Caregiver Burden at 6 and 12 Months|The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Originally a 29-item instrument, the 22-item modified version is easily completed by telephone. This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden. Higher Zarit scores indicate greater caregiver burden. The minimum possible score is 0, and the maximum possible score is 110.|0, 6 and 12 months||||units on a scale||Standard Deviation|Mean
1379702|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|2.5 weeks (or after treatment session 5)|||||||
1379703|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 10 (week 5)|||||||
1379704|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 9 (week 5)|||||||
1379705|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 8 (week 4)|||||||
1379706|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 7 (week 4)|||||||
1379707|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 6 (week 3)|||||||
1379708|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 5 (week 2.5)|||||||
1379709|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 4 (week 2)|||||||
1379710|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 3 (week 2)|||||||
1379711|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 2 (week 1)|||||||
1379712|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 10 (week 5)|||||||
1379713|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 9 (week 5)|||||||
1379714|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 8 (week 4)|||||||
1379715|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 7 (week 4)|||||||
1379716|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 6 (week 3)|||||||
1379717|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 5 (week 2.5)|||||||
1379718|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 4 (week 2)|||||||
1379719|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 3 (week 2)|||||||
1379720|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 2 (week 1)|||||||
1379721|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 10 (week 5)|||||||
1379722|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 9 (week 5)|||||||
1379723|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 8 (week 4)|||||||
1379724|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 7 (week 4)|||||||
1379725|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 6 (week 3)|||||||
1379748|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|12 Week follow up|||||||
1379755|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|26 Week follow up|||||||
1379756|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|12 Week follow up|||||||
1379757|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|5 weeks (or after treatment session 10)|||||||
1379758|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|2.5 weeks (or after treatment session 5)|||||||
1379759|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|26 Week follow up|||||||
1379760|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|12 Week follow up|||||||
1379761|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|5 weeks (or after treatment session 10)|||||||
1379762|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|2.5 weeks (or after treatment session 5)|||||||
1379763|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|26 Week follow up|||||||
1379764|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|12 Week follow up|||||||
1379765|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|5 weeks (or after treatment session 10)|||||||
1379766|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|26 week follow up|||||||
1379767|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|12 week follow up|||||||
1379768|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|2.5 weeks (or after treatment session 5)|||||||
1379769|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|5 weeks (or after treatment session 10)|||||||
1379770|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|2.5 weeks (or after treatment session 5)|||||||
1379771|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 1 (week 1)|||||||
1379772|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 1 (week 1)|||||||
1379773|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 1(week 1)|||||||
1379774|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 1 (week 1)|||||||
1379775|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Screening Visit (Day 1)|||||||
1379776|NCT01459705|Secondary|Behavior and Sympton Identification Scale (BASIS-24)|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)|||||||
1379777|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|Screening Visit(Day 1)|||||||
1379778|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)|||||||
1379779|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|Screening Visit(Day 1)|||||||
1379780|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|Screening Visit(Day 1)|||||||
1379781|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|Screening Visit(Day 1)|||||||
1379782|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|Screening Visit (Day 1)|||||||
1379783|NCT01459705|Secondary|PTSD Checklist- Civilian (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|Screening Visit (Day 1)|||||||
1379784|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|26 Week follow up||||units on a scale||Standard Deviation|Mean
1379785|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|12 week follow up||||units on a scale||Standard Deviation|Mean
1379786|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|5 weeks (or after treatment session 10)|Participants who provided outcome data at post treatment|||units on a scale||Standard Deviation|Mean
1379787|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|2.5 weeks (or after treatment session 5)|Participants who provided data at mid treatment|||units on a scale||Standard Deviation|Mean
1379788|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|Screening Visit (Day 1)|Baseline scores on the CAPS-W (last week reference)|||units on scale||Standard Deviation|Mean
1379789|NCT01459653|Secondary|Patient-level Predictor for Cancer-related Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006 in all patients and those with break-through FN episodes.~Table presents patient level predictors for cancer-related mortality: female gender, poor performance (ECOG >=2) during study.~ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data|||participants|||Number
1379790|NCT01459653|Primary|Incidence of Outcomes|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample|||percentage of participants|||Number
1379791|NCT01459653|Primary|EP2006 Cycles by Treatment Duration|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration|||cycles|Participants||Number
1379792|NCT01459653|Primary|EP2006 Day of Initiation: Cycle Distribution|"Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.~Table presents number of cycles by day after chemotherapy."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of study drug initiation|||cycles|Participants||Number
1379793|NCT01459653|Secondary|Patient-level Predictors for All-cause Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes.~Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG >=2) during study"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data|||participants|||Number
1379794|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score. H/o repeated infections refers at enrollment; H/o: History of"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in evaluable sample with composite outcome data|||participants|||Number
1379795|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients from evaluable sample with composite outcome data|||cycles|Participants||Number
1379796|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related chemotherapy disturbance data|||cycles|||Number
1379797|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with data|||cycles|Participants||Number
1379798|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related hospitalization data|||participants|||Number
1379799|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with CIN/FN-related hospitalization data|||cycles|Participants||Number
1379800|NCT01459653|Secondary|Modeling FN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with FN episode data|||participants|||Number
1379808|NCT01459653|Primary|Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.~Mean and standard error estimated from ANCOVA"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample|||participants|Participants||Number
1380521|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 1 year||||percentage of patients|||Number
1379801|NCT01459653|Secondary|Modeling FN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with FN episode data|||cycles|Participants||Number
1379802|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are shown in the statistical appendices.~H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data|||participants|||Number
1379803|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are added as statistical analyses appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample with any grade 4 CIN data|||cycles|Participants||Number
1379804|NCT01459653|Secondary|Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for liver, renal and/or cardiovascular disease."|||participants|||Number
1379805|NCT01459653|Secondary|Characteristics of Clusters: History of Antibiotic Use for CIN|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~CIN=Chemotherapy Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for history of antibiotic use for CIN."|||participants|||Number
1379806|NCT01459653|Secondary|Characteristics of Clusters: Cancer Stage|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for cancer stage."|||participants|||Number
1379807|NCT01459653|Secondary|Characteristics of Clusters: ECOG Performance Status|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982.~FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for ECOG performance status."|||Scores on a scale||Standard Deviation|Mean
1379809|NCT01459653|Primary|Predictors of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.~Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used.~Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb~Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles for patients in evaluable sample with data|||participants|Participants||Number
1379810|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients with any CIN/FN-related chemotherapy disturbances by treatment decision.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by treatment decision with data|||participants|||Number
1379811|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients with any CIN/FN-related chemotherapy disturbance by prophylaxis type.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type|||participants|||Number
1379812|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients who had a cancer-related death by any/no CIN/FN-related chemotherapy disturbance~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data|||participants|||Number
1379813|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients that had a cancer-related death by any/no grade 4 CIN or FN~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN or FN with data|||participants|||Number
1379814|NCT01459653|Primary|Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table shows number of patients who died by any or no CIN/FN related chemotherapy disturbance.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any or no CIN/FN related chemotherapy disturbance.|||participants|||Number
1379815|NCT01459653|Primary|Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table shows number of patients that died in each group.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN/FN|||participants|||Number
1379844|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 6|||days|Participants|Standard Deviation|Mean
1379816|NCT01459653|Primary|Number of Patients by Cause of Death|Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Safety population, i.e. all patients who received at least one dose of study drug|||participants|||Number
1379817|NCT01459653|Primary|Incidence of Outcomes by Study Drug Duration: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level by study drug duration. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug duration. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.|||percentage of participants|||Number
1379818|NCT01459653|Primary|Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level by day of study drug initiation. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010). *Day of EP2006 initiation- Day 0 (during chemotherapy); **Day of EP2006 initiation- Days 1-3 (per guidelines)"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.|||percentage of participants|||Number
1379819|NCT01459653|Primary|Incidence of Outcomes: Cycles Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||Percentage of participants|||Number
1379820|NCT01459653|Primary|Incidence of Outcomes by Mean GIS: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes by day (mean GIS over all visits). ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by mean GIS|||percentage of participants|||Number
1379821|NCT01459653|Primary|Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug dose|||percentage of participants|||Number
1379845|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 5|||days|Participants|Standard Deviation|Mean
1380132|NCT01457950|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Micromole/liter (UMOL/L)||Standard Deviation|Mean
1379822|NCT01459653|Primary|Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis decision (relative to guidelines)|||percentage of participants|||Number
1379823|NCT01459653|Primary|Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type|||Percentage of participants|||Number
1379824|NCT01459653|Primary|Incidence of Outcomes by Chemotherapy Risk: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by chemotherapy risk|||percentage of participants|||Number
1379825|NCT01459653|Primary|CIN/FN Episodes: Cycle Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.~Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization [RH] or CIN/FN-related chemotherapy disturbance [RCD])"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample|||cycles|Participants||Number
1379826|NCT01459653|Primary|Number of Patients With CIN/FN Episodes: Patient Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance)~A patient may fall into more than one or none of the categories displayed."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||participants|||Number
1379827|NCT01459653|Primary|Absolute Neutrophil Count (ANC) Across All Cycles|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||Per mm^3|Participants|Standard Deviation|Mean
1379828|NCT01459653|Primary|Absolute Neutrophil Count (ANC) at EP2006 Initiation|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of patients in evaluable sample with initial ANC result|||Per mm^3||Standard Deviation|Mean
1379829|NCT01459653|Primary|GCSF Congruence Score (GCS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The GCS is computed at the patient level as an overall grade of how congruent actual GCSF treatment is to recommended treatment. The GCS is computed as follows and scores range from 0 to 3: GCS = Σ(CRS + mean GIS over all cycles + GPS), with higher scores indicating higher congruence.~CRS: Chemotherapy Risk Score (0 or 1 with 1 best); FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS=GCSF Initiation Score (0 to 1 with 1 best); GPS=GCSF persistence score (0 to 1 with 1 best);"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with GCSF congruence score by tumor type|||scores on a scale||Standard Deviation|Mean
1379830|NCT01459653|Primary|GCSF Persistence Score (GPS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in the evaluable sample with a GCSF persistence score (GPS).|||participants|||Number
1379831|NCT01459653|Primary|GCSF Initiation Score (GIS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~ANC=Absolute Neutrophil Count; GIS Score 0 (EP2006 initiated on day 0 of chemotherapy or on day 10 or later); GIS Score 0.50 (EP2006 initiated on days 7-9 of chemotherapy); GIS Score 0.75 (EP2006 initiated on days 4-6 of chemotherapy); GIS Score 1.00 (EP2006 initiated per EORTC guidelines (2010) on days 1-3 after chemotherapy)~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor; GIS=Granulocyte Colony-Stimulating Factor Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)|||Percent of participants|||Number
1379832|NCT01459653|Primary|EP2006 Day of Initiation Relative to Guidelines by Cancer Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines~DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles with initiation on different days during chemotherapy for evaluable sample. A patient may have initiated EP2006 during chemotherapy on different days for different cycles. The categories therefore are not mutually exclusive on a patient level and the sum of patients may therefore exceed the sample size.|||cycles|Participants||Number
1379833|NCT01459653|Primary|Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient’s chemotherapy toxicity (<10%, 10–20% or >20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample: total and by tumor type|||percentage of patients|||Number
1379834|NCT01459653|Primary|Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~FN: Febrile Neutropenia; EORTC: European Organisation for Research and Treatment of Cancer"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||percentage of participants|||Number
1379835|NCT01459653|Primary|Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).~Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type|||Scores on a scale||Standard Deviation|Mean
1379846|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 4|||days|Participants|Standard Deviation|Mean
1379836|NCT01459653|Primary|Patient Risk Score (PRS) for All Patients|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).~Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample|||Scores on a scale||Standard Deviation|Mean
1379837|NCT01459653|Secondary|Characteristics of Clusters: Hemoglobin Study Start|Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for hemoglobin at study start."|||g/dL||Standard Deviation|Mean
1379838|NCT01459653|Secondary|Cohort Identification|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the “high risk group” comprised of only 3.0% of the evaluable sample.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).|||participants|||Number
1379839|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10–20% at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy risk 10–20% in evaluable sample|||percentage of patients|||Number
1379840|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010).~CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample|||percentage of participants|||Number
1379841|NCT01459653|Primary|EP2006 Duration by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
1379842|NCT01459653|Primary|EP2006 Duration by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
1379843|NCT01459653|Primary|EP2006 Duration by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type with data|||days|Participants|Standard Deviation|Mean
1379994|NCT01458561|Secondary|Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)|Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)|After final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||number of participants|||Number
1379847|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 3|||days|Participants|Standard Deviation|Mean
1379848|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 2|||days|Participants|Standard Deviation|Mean
1379849|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 1|||days|Participants|Standard Deviation|Mean
1379850|NCT01459653|Primary|EP2006 Treatment Duration in Any Cycle|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration|||days|Participants|Standard Deviation|Mean
1379851|NCT01459653|Primary|EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
1379852|NCT01459653|Primary|EP2006 Day of Initiation by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
1379853|NCT01459653|Primary|EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
1379854|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 6|||days|Participants|Standard Deviation|Mean
1379855|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 5|||days|Participants|Standard Deviation|Mean
1379856|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 4|||days|Participants|Standard Deviation|Mean
1379857|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 3|||days|Participants|Standard Deviation|Mean
1379858|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 2|||days|Participants|Standard Deviation|Mean
1380037|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3||||participants|||Number
1393544|NCT01324622|Primary|Incidence of Surgical Interventions|Success defined as a lack of revision, removal or addition of supplemental fixation.|up to 24 months||||participants w/o surgical intervention|||Number
1379859|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 1|||days|Participants|Standard Deviation|Mean
1379860|NCT01459653|Primary|EP2006 Day of Initiation: All Cycles|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of initiation of study drug|||days|Participants|Standard Deviation|Mean
1379861|NCT01459653|Primary|EP2006 Dose by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||cycles|Participants||Number
1379862|NCT01459653|Primary|Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type|||participants|||Number
1379863|NCT01459653|Primary|EP2006 Dose by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||cycles|Participants||Number
1379864|NCT01459653|Primary|EP2006 Dose by Patient Weight: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles treated|||cycles|Participants||Number
1379865|NCT01459653|Primary|EP2006 Dose (Cycle 6)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 6 with dose data|||participants|||Number
1379866|NCT01459653|Primary|EP2006 Dose (Cycle 5)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 5 with dose data|||participants|||Number
1379867|NCT01459653|Primary|EP2006 Dose (Cycle 4)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 4 with dose data|||participants|||Number
1379868|NCT01459653|Primary|EP2006 Dose (Cycle 3)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 3 with dose data|||participants|||Number
1379869|NCT01459653|Primary|EP2006 Dose (Cycle 2)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 2 with dose data|||participants|||Number
1379870|NCT01459653|Primary|EP2006 Dose (Cycle 1)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 1 with dose data|||participants|||Number
1379871|NCT01459653|Primary|EP2006 Dose (Enrollment Cycle)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at enrollment cycle with dose data|||participants|||Number
1380522|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100|baseline and 1 year||||percent change||Standard Deviation|Mean
1379872|NCT01459653|Primary|EP2006 Dose (All Cycles)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample|||cycles|Participants||Number
1379873|NCT01459653|Primary|Concomitant Antibiotic Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||participants|||Number
1379874|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Tumor Type|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type|||participants|||Number
1379875|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Age Group|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by age|||participants|||Number
1379876|NCT01459653|Primary|Type of EP2006 Prophylaxis by Gender|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by gender|||participants|||Number
1379877|NCT01459653|Primary|Type of EP2006 Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|"Delayed Primary: EP2006 initiated in cycle 2 or later with no CIN/FN in prior cycle.~True secondary: EP2006 initiated in cycle 2 or later following CIN/FN in prior cycle."|||participants|||Number
1379878|NCT01459653|Primary|Clinical Events Ever During Study (Frequency Threshold: 5%)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)|||participants|||Number
1379879|NCT01459653|Primary|Fever and Infections Ever During the Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).|||participants|||Number
1379880|NCT01459653|Primary|Cancer Treatment Type - Ever Received During Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).|||participants|||Number
1379893|NCT01459016|Secondary|Change From Baseline in the Clinical Dementia Rating (CDR) Total Score|The CDR is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score ranges from 0 to 18. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
1379881|NCT01459653|Primary|Chemotherapy Toxicity (%FN Risk)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician’s best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~Chemotherapy regimens were classified for FN risk (<10% risk, 10-20% risk or >20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data. Please refer to baseline characteristics tables as well.|||participants|||Number
1379882|NCT01459588|Secondary|Change From Baseline in Schirmer Test Results|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||millimeters||Standard Deviation|Mean
1379883|NCT01459588|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Score on as scale||Standard Deviation|Mean
1379884|NCT01459588|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
1379885|NCT01459588|Secondary|Change From Baseline in Tear Break-up Time|Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Seconds||Standard Deviation|Mean
1379886|NCT01459588|Primary|Change From Baseline in Ocular Surface Disease Index© Questionnaire Score|The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
1379887|NCT01459068|Secondary|Alcohol Use|Alcohol use was measured using the Alcohol Use Disorders Identification Test (AUDIT). Respondents reported frequency and amount of alcohol consumed, referencing photographs of local alcohols (local beers, rice whiskeys, etc.). Total scores were calculated as sum totals across the 10-item scale. AUDIT total scores ranged from 0 (best possible outcome) to 40 (worst possible outcome).|10-16 weeks||||units on a scale||Standard Error|Mean
1379888|NCT01459068|Secondary|Aggression Behaviors|The 12-item Aggression Questionnaire (AQ) was adapted for local use. Respondents rated frequency in general of aggressive behaviors from 0 “None of the time” to 4 “Almost all of the time.” Scores were calculated as averages scores for each behavior across the 12-item scale and therefore ranged from 0-4|10-16 weeks||||units on a scale||Standard Error|Mean
1379889|NCT01459068|Secondary|Anxiety Symptoms|Anxiety symptoms were measured using the 10-item HSCL-25 anxiety subscale with local adaptations. Respondent instructions and response categories were the same as the HSCL-25 depression subscale. Scores were calculated as average symptom scores across the 11-item scale and therefore ranged from 0-4|10-16 weeks||||units on a scale||Standard Error|Mean
1379890|NCT01459068|Primary|Posttraumatic Stress Symptoms|Posttraumatic stress symptoms (PTSS) were measured using the 30-symptom items of the Harvard Trauma Questionnaire (HTQ). Response options were the same as the HSCL-25. An algorithm was applied to the HTQ to determine eligibility on the basis of moderate to severe PTSS. The HTQ was also used to measure the PTSS severity outcome: Scores for PTSS were calculated as average symptom scores across the 30 items. PTSS scores ranged from 0 (best possible outcome) to 3 (worst possible outcome).|10-16 weeks||||units on a scale||Standard Error|Mean
1379891|NCT01459068|Secondary|Functional Impairment|Functional impairment was measured using locally-developed, gender-specific scales. The scales contained 16 and 23 tasks for men and women, respectively. Respondents reported current difficulty compared to others of same gender and similar age (from 0 “No difficulty” to 4 “Often cannot do”). Scores were calculated as average task scores across the 16- and 23-item scales and therefore ranged from 0-4|10-16 weeks||||units on a scale||Standard Error|Mean
1379892|NCT01459068|Primary|Depression|Depression symptoms were measured using a modified, locally validated version of the 15-item Hopkins Symptoms Checklist (HSCL-25) depression subscale. Respondents reported symptom frequency in the last month (0 “None of the time” to 3 “Almost always”). An algorithm was applied to the HSCL-25 to determine eligibility on the basis of moderate to severe depression. The HSCL-25 was also used to measure the depression severity outcome: Scores on the depression scale were calculated as average symptom scores across the 17 items and therefore ranged from 0-3|10-16 weeks||||units on a scale||Standard Error|Mean
1379894|NCT01459016|Secondary|Change From Baseline in the Alzheimer’s Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
1379895|NCT01459016|Secondary|Change From Baseline in the Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
1379896|NCT01459016|Secondary|Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T||Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||Participants|||Count of Participants
1379897|NCT01459016|Secondary|Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)||Baseline|All participants who had an MRI during screening and were classified as screen failures.|||Participants|||Count of Participants
1379898|NCT01459016|Secondary|Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir|Composite summary standardized uptake value ratio (SUVR) normalized to mean whole cerebellum. Regions used for composite summary were posterior cingulum, anterior cingulum, parietal cortex, lateral temporal cortex and frontal cortex.|Baseline|All participants with an amyloid positive florbetapir F 18 PET scan at baseline.|||SUVR unit 1||Standard Deviation|Mean
1379899|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)|DTI scans used MD to measure the overall magnitude of water diffusion in selected WM tracts, without specific regard to directionality. ROI: CC, IC, PCB, TWM, UF, SLF. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||square meters per second (m²/sec) * 10¹⁰||95% Confidence Interval|Least Squares Mean
1379900|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)|DTI scans used FA to measure water diffusion directionality in selected white matter (WM) tracts. ROI: Corpus collosum (CC), internal capsule (IC), posterior cingulum bundle (PCB), temporal white matter (TWM), uncinate fasciculus (UF), superior longitudinal fasciculus (SLF). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||au||95% Confidence Interval|Least Squares Mean
1379901|NCT01459016|Primary|Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)|Distributed functional connectivity in selected brain networks was calculated from the rsfMRI scans. Values were derived from low-frequency (0.01-0.1 hertz [Hz]) temporal correlations between different regions over the approximately 6-minute rsfMRI time series scan. Distributed measures of functional connectivity were calculated as the mean Pearson correlation between the average low-frequency time courses in predefined sets of regions of interest (ROI) within the default mode network (DMN), salience network (SN) and sensorimotor networks (SMN). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||arbitrary units (au)||95% Confidence Interval|Least Squares Mean
1379902|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)|Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||percentage of hippocampus volume average||95% Confidence Interval|Least Squares Mean
1379903|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)|BBSI and VBSI were calculated based on the voxel-wise difference between co-registered baseline and follow-up scans. Least squares (LS) mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||milliliters (mL)||95% Confidence Interval|Least Squares Mean
1379904|NCT01458990|Secondary|Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy|Analysis at baseline will be compared to that at 2 weeks. This will be specifically, changes in those with PPI withdrawal compared to those with PPI initiation|2 weeks|No safety or tolerability issues were seen during the study|||Participants|||Count of Participants
1379905|NCT01458990|Primary|Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation|Analysis at baseline will be compared to that at 2 weeks using Multitagged sequencing. Number of patients with overgrowth of oral microbiota in their stool after PPI therapy withdrawal or initiation were specifically analyzed.|2 weeks|Comparison were made between groups on/off PPI therapy using Linear discriminant analysis effect size (LEFSe) and using the Quantitative Insights Into Microbial Ecology (QIIME) pipeline and also the relative proportion (%) of oral-origin microbiota were studied|||Participants|||Count of Participants
1379906|NCT01458951|Secondary|Change From Baseline in Total Mayo Score at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Baseline, Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1379907|NCT01458951|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in Partial Mayo scores at Weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each graded from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1379908|NCT01458951|Secondary|Partial Mayo Scores|A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1379909|NCT01458951|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379910|NCT01458951|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379911|NCT01458951|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379912|NCT01458951|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379913|NCT01458951|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379914|NCT01458951|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379915|NCT01458951|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
1379916|NCT01458639|Secondary|Safety of Technegas in Patients With Possible PE|Safety will be assessed by the incidence of treatment emergence adverse events and changes in clinical laboratory measurements, blood pressure, oxygen saturation, physical examination and pulmonary examination before and after treatment.|Prospective, from enrollment through 30 days follow-up|All subjects who received Technegas and completed safety follow-up procedures.|||participants|||Number
1379928|NCT01458587|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks Post PDT #1|ITT observed|||participants|||Number
1379917|NCT01458639|Secondary|Likelihood Ratio for Diagnosis of PE|Likelihood ratios of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
1379918|NCT01458639|Secondary|Negative Predictive Value (NPV) of Imaging for Diagnosis of PE|NPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
1379919|NCT01458639|Secondary|Positive Predictive Value (PPV) of Imaging for Diagnosis of PE|PPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
1379920|NCT01458639|Secondary|Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE|Accuracy of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|prospective, 30 days follow-up.|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
1379921|NCT01458639|Primary|Specificity of Technegas V/Q SPECT for the Diagnosis of PE.|"Compared to the specificity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
1379922|NCT01458639|Primary|Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE|"Compared to the sensitivity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
1379923|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT observed|||participants|||Number
1379924|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT observed|||participants|||Number
1379925|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2 after PDT #1|ITT observed|||participants|||Number
1379926|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT observed|||participants|||Number
1379927|NCT01458587|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks Post PDT #1|ITT observed|||participants|||Number
1379929|NCT01458587|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks Post PDT #1|ITT observed|||participants|||Number
1379930|NCT01458587|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT observed|||participants|||Number
1379931|NCT01458587|Secondary|Stinging/Burning at Visit 5|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT, observed|||participants|||Number
1379932|NCT01458587|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT, observed|||participants|||Number
1379933|NCT01458587|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT, observed|||participants|||Number
1379934|NCT01458587|Secondary|Stinging/Burning Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT, observed|||participants|||Number
1379935|NCT01458587|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT, observed|||participants|||Number
1379936|NCT01458587|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT, observed|||participants|||Number
1379937|NCT01458587|Secondary|Edema at Visit 5|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT|||participants|||Number
1379938|NCT01458587|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT|||participants|||Number
1379939|NCT01458587|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 Weeks after PDT #1|ITT|||participants|||Number
1379940|NCT01458587|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT #1|ITT|||participants|||Number
1379941|NCT01458587|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT|||participants|||Number
1379942|NCT01458587|Secondary|Erythema at Visit 5|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT|||participants|||Number
1379943|NCT01458587|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT|||participants|||Number
1379944|NCT01458587|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT|||participants|||Number
1379945|NCT01458587|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT #1|ITT|||participants|||Number
1379946|NCT01458587|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT|||participants|||Number
1379947|NCT01458587|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|12 Weeks after PDT #1|ITT|||participants|||Number
1379948|NCT01458587|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|8 Weeks after PDT #1|ITT|||participants|||Number
1379949|NCT01458587|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|2 Weeks after PDT #1|ITT|||participants|||Number
1379950|NCT01458587|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Baseline|ITT|||participants|||Number
1379951|NCT01458587|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 weeks after PDT #1|ITT|||participants|||Number
1379952|NCT01458587|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 weeks after PDT #1|ITT|||participants|||Number
1379953|NCT01458587|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 weeks after PDT #1|ITT|||participants|||Number
1379954|NCT01458587|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT|||participants|||Number
1379955|NCT01458587|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|ITT|||participants|Participants||Number
1379956|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 12|ITT LOCF|||arms >75% cleared|Participants||Number
1379957|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 8|ITT LOCF|||arms >75% cleared|Participants||Number
1379958|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 12|ITT LOCF|||arms 100% cleared|Participants||Number
1379959|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 8|ITT LOCF|||arms 100% cleared|Participants||Number
1379960|NCT01458587|Secondary|Lesion Clearance Rate||Week 8|ITT LOCF|||percentage of lesions cleared|Participants|Standard Deviation|Median
1379961|NCT01458587|Primary|Lesion Clearance Rate|Clearance rate for all lesions|Week 12|ITT analysis with LOCF|||percentage of lesions cleared|Participants|Standard Deviation|Median
1379970|NCT01458574|Secondary|Percentage of Participants in Endoscopic Remission at Week 24 and 52|Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1393713|NCT01323270|Secondary|Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens||1 month after Vaccination 1||||International Units per milliliter||95% Confidence Interval|Geometric Mean
1379962|NCT01458574|Secondary|Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline|Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379963|NCT01458574|Secondary|Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline|Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379964|NCT01458574|Secondary|Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline|Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379965|NCT01458574|Secondary|Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline|Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379966|NCT01458574|Secondary|Percentage of Participants in Remission, Among Participants With Remission at Baseline|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379967|NCT01458574|Secondary|Change From Baseline in Total Mayo Score at Week 24 and 52|Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.|Baseline, Week 24, 52|FAS included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
1379968|NCT01458574|Secondary|Total Mayo Score at Baseline, Week 24 and 52|Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Baseline, Week 24, 52|FAS included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1379969|NCT01458574|Secondary|Percentage of Participants in Sustained Endoscopic Remission|Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379993|NCT01458561|Secondary|Total Time of Operative Procedure||Skin cut to skin closure (average 4-5 hour duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||minutes|||Number
1379971|NCT01458574|Secondary|Percentage of Participants in Sustained Symptomatic Remission|Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379972|NCT01458574|Secondary|Percentage of Participants in Symptomatic Remission at Week 24 and 52|Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379973|NCT01458574|Secondary|Percentage of Participants in Sustained Deep Remission|Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379974|NCT01458574|Secondary|Percentage of Participants in Deep Remission at Week 24 and 52|Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379975|NCT01458574|Secondary|Percentage of Participants in Sustained Clinical Remission|Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379976|NCT01458574|Secondary|Percentage of Participants in Clinical Remission at Week 24 and 52|Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379977|NCT01458574|Secondary|Percentage of Participants With Sustained Clinical Response|Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379978|NCT01458574|Secondary|Percentage of Participants With Clinical Response at Week 24 and 52|Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379979|NCT01458574|Secondary|Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline|Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379980|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline|Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379981|NCT01458574|Secondary|Percentage of Participants With Sustained Mucosal Healing|Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379982|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 24|Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24|FAS included all randomized participants.|||percentage of participants|||Number
1379983|NCT01458574|Secondary|Percentage of Participants in Sustained Remission|Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
1379984|NCT01458574|Secondary|Percentage of Participants in Remission at Week 24|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24|FAS included all randomized participants.|||percentage of participants|||Number
1379985|NCT01458574|Secondary|Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline|Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
1379986|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 52|Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 52|FAS included all randomized participants.|||percentage of participants|||Number
1379987|NCT01458574|Primary|Percentage of Participants In Remission at Week 52|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.|Week 52|FAS included all randomized participants.|||percentage of participants|||Number
1379988|NCT01458561|Secondary|Number of Procedure Complications and/or Adverse Events||Through final follow-up (2 years postoperatively)||||Number of complications and AEs|||Number
1379989|NCT01458561|Secondary|Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers|Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points|Preoperatively (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postoperatively, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yr postop|Blood samples were to be analyzed in batches to more accurately assess for any changes over time; the study was terminated before the first batch was analyzed, so no data is available for anti-BSA titer testing.||||||
1379990|NCT01458561|Secondary|Subjects Requiring Additional Hospitalization/Surgical Intervention|Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up|Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||# of participants|||Number
1379991|NCT01458561|Secondary|Total Hospitalization Time|Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)|Hospital admission (day of surgery) until hospital discharge (average 5-7 days)|Study terminated before any subjects were enrolled into the BioFoam arm|||days|||Number
1379992|NCT01458561|Secondary|Core Body Temperature||At the time of test or control article application (expected average 3-4 hours from skin cut)|Study terminated before any subjects were enrolled into the BioFoam arm|||degrees Celcius|||Number
1379995|NCT01458561|Secondary|Eval. for Presence of Device by MRI w/ & w/Out Contrast, & Diagnose/Eval. Abdominal Fluid Collection/Biliary Leak, Residual Scarring, Hepatic Regeneration, & Assess for Emergence of Primary/Recurrent Malignancy by MRI w/ or w/Out Contrast as Appropriate||Within 48 hours postoperatively, up to 48 hours prior to hospital discharge (avg. 5-7 days postoperatively), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively||||participants|||Number
1379996|NCT01458561|Secondary|Subject Laboratory Evaluations|Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up|Preoperatively through final 2 year follow-up|Study terminated before any subjects were enrolled into the BioFoam arm|||Number of participants with labs in rang|||Number
1379997|NCT01458561|Secondary|Amount of Intraoperative Blood Products Administered|Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)|Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||units of blood product(s)|||Number
1379998|NCT01458561|Secondary|Duration of Drainage|Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm|||hours|||Number
1379999|NCT01458561|Secondary|Amount of Postoperative Fluid Loss|Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]|Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm|||milliliters (mL)|||Number
1380000|NCT01458561|Secondary|Amount of Postoperative Bilious Drainage||Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm|||milliliters (mL)|||Number
1380001|NCT01458561|Secondary|Intraoperative Blood Loss|Amount of blood lost between time of initial application of prescribed hemostatic agent and confirmed achievement of hemostasis (achievement of hemostasis eval. out to 10 minutes following application of prescribed hemostatic agent)|Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)|Study terminated before appropriate data collection/analysis||||||
1380002|NCT01458561|Secondary|Achievement of Immediate Hemostasis|Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent|1 minute after application of prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm|||participants|||Number
1380003|NCT01458561|Secondary|Time to Hemostasis|"Number of subjects achieving hemostasis [by assessing for hemostasis (yes/no)] at pre-determined time points: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent. Time to hemostasis is recorded as the first of the predetermined time points to receive a yes assessment."|1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent|Study terminated before any subjects were enrolled into the BioFoam arm|||minutes|||Number
1380004|NCT01458561|Primary|Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent|Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent|3 minutes following a single application of the prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm|||participants|||Number
1380005|NCT01458535|Secondary|Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)|Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 48|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.|||percentage of participants|||Number
1380006|NCT01458535|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
1380007|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
1380008|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
1380009|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
1383989|NCT01422070|Primary|Vital Status at Hospital Discharge|Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital|Max 90 days after admission to the Study Unit||||participants|||Number
1380010|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
1380011|NCT01458535|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
1380012|NCT01458522|Secondary|Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30|Percentage of all subjects who have had a seizure, are on antiepileptic drug (AED) therapy, and are alive and dead at day 30. Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in a greater effect on seizures, antiepileptic drug (AED) use, and survival at day 30 after the acute treatment period. The acute treatment period could range from 6 to 30 hours.|both acute treatment periods to 30 days||||percentage of participants|||Number
1380013|NCT01458522|Secondary|Change in Functional Status as Measured by the Functional Disability Scale at Day 7 to 9 Postrandomization and Day 30 Post-randomization in the LCM vs fPHT Arms.|Change in functional status as measured by the Functional Disability Scale, using a 0-29 rating (0=w/o disability; 29=extreme vegetative state) at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM first, then fPHT versus fPHT first, then LCM arms. Data was analyzed in a manner consistent with determining if one treatment arm resulted in a greater change in functional status than the other.|Baseline to day 7-9, baseline to day 30|participants who completed the Functional Disability Scale|||units on a scale||Standard Deviation|Mean
1380014|NCT01458522|Secondary|Days in the Intensive Care Unit/Hospital|Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in more days of hospitalization than the other over the course of the study.|initial bolus to end of study||||days||Standard Deviation|Mean
1380015|NCT01458522|Secondary|Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1|Percentage of subjects in whom study drug is withdrawn early after treatment with treatment arm 1|baseline to end of treatment arm 1||||Participants|||Count of Participants
1380016|NCT01458522|Secondary|Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration|Number of predefined adverse events (AE) after treatment arm 1 administration. These predefined adverse events include Patients with at least one AE of interest, Cardiac disorders, investigations, suspected hypersensitivity reactions, vascular disorders, and hypotension.|24 hours|Patients who received treatment arm 1|||Number of predefined AEs|||Number
1380017|NCT01458522|Secondary|Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm|Time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm|time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm|participants who had satisfactory EEG data (sometimes EEG leads would come off)|||hours||Standard Deviation|Mean
1380018|NCT01458522|Secondary|Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm|Absolute change defined as the number of minutes of ESz activity per hour before treatment and at the end of the second treatment arm. This measure does not evaluate seizure activity in the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour.|baseline, 26-68 hours|participants who had satisfactory EEG data (sometimes EEG leads would come off)|||min/hour||Standard Deviation|Mean
1380019|NCT01458522|Secondary|Seizure Burden Change From Baseline to End of Initial Treatment|Absolute change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour. The maximum amount of time that can be used to determine baseline seizure time is 6 hours.|Baseline, 24 hours|Participants who had satisfactory EEG data (sometimes EEG leads would come off)|||min/hour||Standard Deviation|Mean
1380020|NCT01458522|Secondary|Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS)|Number of subjects who required a second antiepileptic drug (AED) to control nonconvulsive seizures (NCS)|24-26 hours|Participants who crossed over to second drug|||Participants|||Count of Participants
1380021|NCT01458522|Secondary|Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms.|The percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms.|24 hours|Data are reported for the percentage of participants who require a rebolus of the initial antiepileptic drugs (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms in the period prior to crossover.|||Participants|||Count of Participants
1380022|NCT01458522|Primary|Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring.|Percentage of subjects who experience no nonconvulsive seizures (NCS) for 24 hours (after the 2-hour observation-only period) following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring with blinded review.|24 hours|Data are reported for the percentage of participants without a nonconvulsive seizure event in the period prior to crossover.|||Participants|||Count of Participants
1380038|NCT01458275|Secondary|Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.|Weeks 0 - 2||||Days|||Number
1380023|NCT01458392|Secondary|Disease Control Rate|Disease control rate will be estimated as the proportion of patients evaluable for response who meet the criteria for complete response, partial response, or stable disease.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.|||percentage of participants||95% Confidence Interval|Number
1380024|NCT01458392|Secondary|Overall Survival (OS)|OS is calculated as the number of months from date of the first dose to the date of death. The last patient treated will be followed for overall survival for 1 year following treatment initiation.|Survival captured until death or at a minimum 1 year from first dose of dalantercept.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.|||weeks||95% Confidence Interval|Median
1380025|NCT01458392|Secondary|Progression Free Survival (PFS)|PFS is defined as the date of the first dose to the first observation of disease progression (according to RECIST v.1.1) or death due to any cause. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.|||weeks||95% Confidence Interval|Median
1380026|NCT01458392|Secondary|Dalantercept Serum Concentration After Single and Multiple Doses|Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1).|Up to 43 days from initiation of treatment.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1380027|NCT01458392|Secondary|Dalantercept Serum Concentration After Single and Multiple Doses|Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1).|Up to 43 days from initiation of treatment.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.|||ng*day/mL||Geometric Coefficient of Variation|Geometric Mean
1380028|NCT01458392|Secondary|Safety and Tolerability|Number of participants with at least one adverse event as a measure of safety and tolerability.|Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.||||participants|||Number
1380029|NCT01458392|Primary|Objective Response Rate (ORR)|ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.|||participants||95% Confidence Interval|Number
1380030|NCT01458288|Secondary|Circulating CD34+ Cell Count in Peripheral Blood|Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.|pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.||||cells/kg||Full Range|Median
1380031|NCT01458288|Secondary|the Average Number of Leukapheresis Sessions|To determine the average number of leukapheresis sessions required to collect 2.5 x10^6 CD34+ cells/kg.|1 week||||number of leukapheresis sessions||Standard Deviation|Mean
1380032|NCT01458288|Primary|Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg|"Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD).~Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8."|1 week||||participants|||Number
1380033|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3||||Percentage of participants|||Number
1380034|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3||||participants|||Number
1380035|NCT01458275|Secondary|Treatment-emergent AEs Causing Study Medication Discontinuation||Weeks 0 - 3||||participants|||Number
1380036|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3||||Percentage of participants|||Number
1380039|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement"|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
1380040|NCT01458275|Secondary|Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
1380041|NCT01458275|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
1380042|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
1380043|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
1380044|NCT01458275|Primary|Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatmentgroup with completed assessment|||units on a scale||Standard Error|Least Squares Mean
1380045|NCT01458249|Secondary|Best Overall Response (BOR)|The best overall response categories (CR, PR, SD [including non-CR/non-PD], PD, not evaluable [NE], and unknown [UNK]) were derived based on time point tumor responses during the study as assessed by the IRC as well as the investigator. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. BOR of SD must have occurred at least 35 days (at least 5 weeks) after the first dose of study drug. If a participant had a BOR of non-CR/non-PD, the participant's BOR was grouped with the SD category.|Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants|||Number
1380046|NCT01458249|Secondary|Durable Stable Disease (SD) Rate (dSDR)|Durable stable disease rate was defined as the percentage of participants who manifested durable stable disease (the duration of stable disease for greater than or equal to eleven weeks) and was estimated based on the tumor response assessments performed according to RECIST v1.1. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. A 2-sided 95% CI was calculated using the exact method of binomial distribution.|Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
1380047|NCT01458249|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who had a BOR of CR + PR + dSD (duration of SD greater than or equal to 11 weeks [77 days] after the first dose of study treatment). Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. For participants whose BOR was SD, the duration of SD was defined as the time from the date of the first dose of study treatment to the first documented PD or death, whichever occurred first (i.e., same definition of PFS). If the dSD was censored at a time less than 11 weeks, the participant was considered as not having a clinical benefit. A 95% CI was calculated using exact method of binomial distribution.|First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
1380048|NCT01458249|Secondary|Disease Control Rate (DCR)|Disease control rate was defined as the percentage of participants who had BOR of CR + PR + SD. BOR of SD must have manifested at least five weeks (35 days) after the first dose of study treatment. Tumor assessment was performed at Week 6 and Week 12 after the start of treatment, and every six weeks thereafter. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started. A 95% CI was calculated using exact method of binomial distribution.|Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
1380049|NCT01458249|Secondary|Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants who had a best overall rate (BOR) of CR or PR. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. The BOR of CR and PR in this study required confirmation by a subsequent assessment of response at least four weeks (28 days) later. CR and PR were determined by the Investigator and IRC using RECIST v1.1 for target lesions assessed by MRI/CT scans. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A 95% CI was calculated using exact method of binomial distribution.|Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
1380050|NCT01458249|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of treatment start to the date of death from any cause. Participants were followed for survival every twelve weeks after PD. In the absence of confirmation of death, participants were censored either at the date that the participant was last known alive or the date of study cutoff, whichever came earlier. Participants censored before database cutoff included those who were lost to follow up and who withdrew consent. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method is used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Months||95% Confidence Interval|Median
1380051|NCT01458249|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from the date of treatment start to the first documented date of event (disease progression or death from any cause, whichever occurred first). PFS was assessed every six weeks (until disease progression was confirmed, or sooner, if clinically indicated) and was based on Investigator and Independent Review Committee (IRC) assessments according to RECIST v1.1. Disease progression was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors and defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method was used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Months||95% Confidence Interval|Median
1380066|NCT01458171|Secondary|Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'|"Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as “very good”, “good”, “fair”, or “poor”. The reported percentage represents the percentage of subjects with local tolerability assessments of very good or good at any given study infusion."|24 to 72 hours after infusion|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.|||percentage of infusions|||Number
1380067|NCT01458171|Secondary|Number of Subjects With Newly Developing or Worsening AEs|Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.|||participants|||Number
1380052|NCT01458249|Primary|Progression-free Rate at 12 Weeks (PFR12wks)|The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution.|Week 12|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||90% Confidence Interval|Number
1380053|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen – Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.|||hours||Full Range|Median
1380054|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen – Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1380055|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.|||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1380056|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.|||hours||Full Range|Median
1380057|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1380058|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.|||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1380059|NCT01458171|Other Pre-specified|Rate of Infection Episodes (Serious and Non-serious)|The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the FAS population and the PPS population and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||infection episodes per subject year|Participants||Number
1380060|NCT01458171|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||days||Full Range|Median
1380061|NCT01458171|Secondary|Number of Days of Hospitalization Due to Infections.|Median number of days of hospitalization due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||days||Full Range|Median
1380062|NCT01458171|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||days||Full Range|Median
1380063|NCT01458171|Secondary|Number of Infection Episodes (Serious and Non-serious)||24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||infection episodes|||Number
1380064|NCT01458171|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||SBIs per subject year|Participants||Number
1380065|NCT01458171|Secondary|IgG Trough Level|Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown|24 weeks|The Full Analysis Set (FAS) comprised all subjects receiving at least 1 IgPro20 infusion. The Per Protocol Set (PPS) comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||g/L||Standard Deviation|Mean
1380068|NCT01458171|Secondary|Overall Rate of AEs Per Infusion|The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.|||AEs per infusion|Participants||Number
1380069|NCT01458171|Primary|Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion|The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The All Treated (AT) set comprised all subjects receiving at least 1 IgPro20 infusion.|||AEs per infusion||Full Range|Median
1380070|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; Two-stage Chromogenic Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
1380071|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; One-stage aPTT Clotting Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
1380072|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1380073|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1380074|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; Two-stage Chromogenic Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1380075|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; One-stage aPTT Clotting Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
1380133|NCT01457950|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1380076|NCT01458106|Secondary|Volume at Terminal Phase (Vz; Two-stage Chromogenic Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
1380077|NCT01458106|Secondary|Volume at Terminal Phase (Vz; One-stage aPTT Clotting Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
1380078|NCT01458106|Secondary|Lambda Z (Two-stage Chromogenic Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||1/hours||95% Confidence Interval|Geometric Mean
1380079|NCT01458106|Secondary|Lambda Z (One-stage aPTT Clotting Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||1/hours||95% Confidence Interval|Geometric Mean
1380080|NCT01458106|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1380081|NCT01458106|Secondary|Time at Maximum Activity (Tmax; One-stage aPTT Clotting Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1380082|NCT01458106|Secondary|Incremental Recovery (IR; Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1380083|NCT01458106|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1380134|NCT01457950|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed. .|||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
1380084|NCT01458106|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1380085|NCT01458106|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1380086|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1380087|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1380088|NCT01458106|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
1380089|NCT01458106|Secondary|Volume at Steady State (Vss; One-stage aPTT Clotting Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
1380090|NCT01458106|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1380091|NCT01458106|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1380135|NCT01457950|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Grams (G)/Liter (L)||Standard Deviation|Mean
1380092|NCT01458106|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1380093|NCT01458106|Secondary|Elimination Half Life (t1/2; One-stage aPTT Clotting Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1380094|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; Two-stage Chromogenic Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL||95% Confidence Interval|Geometric Mean
1380095|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL||95% Confidence Interval|Geometric Mean
1380096|NCT01458106|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.|||IU/kg|Bleeding Episodes|Full Range|Median
1380097|NCT01458106|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
1380098|NCT01458106|Secondary|Number of Days From Last Treatment Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.|||days|Evaluable Spontaneous Bleeding Episodes|Inter-Quartile Range|Median
1380136|NCT01457950|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1380099|NCT01458106|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Consumption was calculated overall for all participants and for the last 3 months (91 days) on study, counted backwards from the end of the efficacy period, for participants with at least 24 weeks on study.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and ≥ 24 weeks on study.|||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
1380100|NCT01458106|Secondary|Physician’s Global Assessment of the Participant’s Response to His rFVIIIFc Regimen|Investigators assessed each participant’s response to his rFVIIIFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFVIIIFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of responses.|||percentage of responses|Responses||Number
1380101|NCT01458106|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment (provided by the caregiver) of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of first injections for which a response was provided, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within approximately 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had a bleeding episode; participants with a non-evaluable bleed are counted in the number of participants analyzed, but not the percentages.|||percent of 1st injections w/ a response|Injections||Number
1380102|NCT01458106|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleed=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last inject|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period is of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
1380103|NCT01458106|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period was of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
1380104|NCT01458106|Primary|Occurrence of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥50 EDs to rFVIIIFc. In addition, the incidence for all participants, regardless of their EDs to rFVIIIFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26|Safety Analysis Set: participants who received at least 1 dose of prestudy FVIII, or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
1380131|NCT01457950|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
1380105|NCT01457950|Other Pre-specified|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.|Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Participants|||Number
1380106|NCT01457950|Other Pre-specified|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||Participants|||Number
1380107|NCT01457950|Other Pre-specified|Change From Baseline in Red Cell Distribution Width at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||percentage (%) of mean RBC volume||Standard Deviation|Mean
1380108|NCT01457950|Other Pre-specified|Change From Baseline in Red Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1380109|NCT01457950|Other Pre-specified|Change From Baseline in Mean Corpuscle Hemoglobin at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||Picograms (PG)/cell)||Standard Deviation|Mean
1380110|NCT01457950|Other Pre-specified|Change From Baseline in Hematocrit at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||Proportion of RBCs in blood||Standard Deviation|Mean
1380111|NCT01457950|Other Pre-specified|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
1380112|NCT01457950|Other Pre-specified|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Micromole/liter (UMOL/L)||Standard Deviation|Mean
1380113|NCT01457950|Other Pre-specified|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1380114|NCT01457950|Other Pre-specified|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
1380115|NCT01457950|Other Pre-specified|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Grams (G)/Liter (L)||Standard Deviation|Mean
1380116|NCT01457950|Other Pre-specified|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Ratio||Standard Deviation|Mean
1380117|NCT01457950|Other Pre-specified|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Month 6 to Month 12|ITT-OL Population|||Participants|||Number
1383990|NCT01421719|Primary|Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment.|Requirement for catheter because of urinary retention.|zero to six months||||participants|||Number
1380118|NCT01457950|Other Pre-specified|Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.|||Percent change||Inter-Quartile Range|Median
1380119|NCT01457950|Other Pre-specified|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline – measure at Baseline) divided by measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.|||Percent change||Inter-Quartile Range|Median
1380120|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.|||Percent change||Standard Error|Mean
1380121|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.|||Percent change||Standard Error|Mean
1380122|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 – measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.|||Percent change||Standard Error|Mean
1380123|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.|||Percent change||Standard Error|Mean
1380124|NCT01457950|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.|Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Participants|||Number
1380125|NCT01457950|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Participants|||Number
1380126|NCT01457950|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||percentage (%) of mean RBC volume||Standard Deviation|Mean
1380127|NCT01457950|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1380128|NCT01457950|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
1380129|NCT01457950|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Picograms (PG)/cell||Standard Deviation|Mean
1380130|NCT01457950|Secondary|Change From Baseline in Hematocrit at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Proportion of RBCs in blood||Standard Deviation|Mean
1384224|NCT01418482|Secondary|Pain|To evaluate pain during dressing removal at visit 4,(after one week) with John Hopkins pain scale. Measured 0=no pain, 100= worst pain, scale from 0-100 mm|3 weeks||||units on a scale||Inter-Quartile Range|Median
1380137|NCT01457950|Secondary|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.|||Participants|||Number
1380138|NCT01457950|Secondary|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline – measure at Baseline) divided by measure at Baseline * 100.|Baseline, Months 1, 3 and 6|ITTE Population. Only participants at the specified time points were analyzed.|||Percent change||Inter-Quartile Range|Median
1380139|NCT01457950|Secondary|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline, Month 1 and Month 6|ITTE Population|||Percent change||Standard Error|Mean
1380140|NCT01457950|Secondary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 1|ITTE Population|||Percent change||Standard Error|Mean
1380141|NCT01457950|Primary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 – measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.|||Percent change||Standard Error|Mean
1380142|NCT01457924|Secondary|Cumulative Volume of New T1 Hypointense Lesions at Week 24 and Week 48|Lesion volume is a measure of lesion size determined by a MRI brain scan. Baseline is defined as the participant’s last available assessment prior to initiation of IP. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.|Baseline, Week 24 and Week 48|ITT Population. Only those par. available at the specified time points were analyzed.|||mm^3||Standard Deviation|Mean
1380143|NCT01457924|Secondary|Cumulative Number of New T1 Hypointense Lesions at Week 24 and Week 48|The cumulative number of new T1 hypointense lesions at week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.|Week 24 and Week 48|ITT Population. Only those par. available at the specified time points were analyzed.|||Number of lesions||Standard Deviation|Mean
1380144|NCT01457924|Secondary|Total Volume of New and/or Newly Enlarging T2 Lesions at Week 12|Lesion volume is a measure of lesion size determined by a MRI brain scan. T2 lesions, are indicative of brain myelin content.The cumulative volume of new and/or newly enlarging T2 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||mm^3||Standard Deviation|Mean
1380145|NCT01457924|Secondary|Cumulative Number of New and Newly Enlarging GdE T2 Lesions at Week 12|The cumulative number of new and newly enlarging GdE T2 lesions (NET2L) at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of NET2L per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Cumulative number of lesions||Standard Deviation|Mean
1380146|NCT01457924|Secondary|Total Volume of All (New and Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12|Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of all (new and persistent) GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of all (new and persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||mm^3||Standard Deviation|Mean
1380159|NCT01457846|Secondary|Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)||Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)|This secondary analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients).|||Patients|||Number
1380147|NCT01457924|Secondary|Total Volume of New GdE Brain Lesions on T1-weighted MRI at Week 12|Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of new GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of new GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
1380148|NCT01457924|Secondary|Cumulative Number of All (New Plus Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12|The cumulative number of all (new plus persistent) GdE T1 lesion at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of all (new plus persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Cumulative number of lesions||Standard Deviation|Mean
1380149|NCT01457924|Secondary|Cumulative Number of Persistent GdE Brain Lesions on T1-weighted MRI at Week 12|The cumulative number of persistent GdE T1 lesions at Week 12 were analyzed from screen based on MRI scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Number of lesions per scan||Standard Deviation|Mean
1380150|NCT01457924|Secondary|Change From Baseline in Brain Volume at Week 24 and Week 48|Brain volume is a measure of brain size determined by a MRI scan. Baseline is defined as the par. last available assessment prior to initiation of the IP (i.e. Screening). Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value.|Baseline (Week 0), Week 24 and Week 48|ITT Population. Only those par. available at the specified time points were analyzed.|||Cubic centimeters||Standard Deviation|Mean
1380151|NCT01457924|Secondary|Cumulative Number of New GdE T1 Lesions at Week 24|The cumulative number of new GdE T1 lesion at Week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE T1 lesions per scan at Week 24 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each participant analyzed.|Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Cumulative number of lesions||Standard Deviation|Mean
1380152|NCT01457924|Primary|Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12|The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE lesions per scan at Week 12 were determined from the model. The all evaluable scans (AES) dataset was used which included all evaluable on-treatment MRI scans for each participant analysed.|Week 12|Intent-to-Treat (ITT) Population comprised of all randomized par. who received at least one dose of IP and who had at least one post screen MRI assessment. Only those par. available at the specified time points were analyzed. Please see footnote of statistical analysis 1 for discrepancy in analysis population Week 24 and 48.|||Cumulative number of lesions||Standard Deviation|Mean
1380153|NCT01457885|Secondary|Incidence of Relapse||2 years|75 patients were enrolled. One patient was not treated. 3 patients were pediatric and therefore left off of this analysis.|||percentage of patients||95% Confidence Interval|Number
1380154|NCT01457885|Secondary|The Percentage of Patients Alive at 1 Year|Overall survival was calculated following transplant using a CloBu4 conditioning regimen for patients with non-remission AML|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.|||percentage of patients||95% Confidence Interval|Number
1380155|NCT01457885|Primary|Cumulative Incidence of Non Relapse Mortality (NRM)|Percentage of patients passed without relapse/recurrence at 1 year.|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.|||percentage of patients||95% Confidence Interval|Number
1380156|NCT01457846|Secondary|Percentage of Patients Without Progressive Disease at 8 Weeks|PD = A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diamters|Week 8 (±1 week)|Full analysis set - all treated patients|||Percentage of patients|||Number
1380157|NCT01457846|Secondary|Percentage Change From Baseline at Week 8 in Target Lesion Size|A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.|Baseline, Week 8 (±1 week)|Full analysis set - all treated patients with at least one post baseline RECIST target lesion assessment scan|||Percentage change||Standard Deviation|Mean
1380158|NCT01457846|Secondary|Objective Response Rate|ORR=Percentage of patients with at least one visit response of CR (complete response) or PR (partial response) that is confirmed at least 4 weeks later; CR:disappearance of target lesions and no new lesions; PR is at least 30% decrease in sum of diameters of lesions taking as a reference the smallest sum since treatment started.|Week 8 (±1 week) and then every 8 weeks (±1 week)|The analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients).|||Patients (%)|||Number
1380160|NCT01457846|Primary|Median Progression Free Survival|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).|Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)|Full analysis set|||months|||Number
1380161|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 2)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH.|||IU/L||Standard Deviation|Mean
1380162|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 1)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH.|||IU/L||Inter-Quartile Range|Mean
1380163|NCT01457703|Primary|Changes in Pregnanediol Glucuronide (PdG) (Aim 2)|Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.|Averaged over the length of menstrual cycle|This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG.|||ug/cycle||Standard Deviation|Mean
1380164|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude.|||IU/L||Standard Deviation|Mean
1380165|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1.|||IU/L||Inter-Quartile Range|Mean
1380166|NCT01457573|Secondary|Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.|Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses.|change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores||||ratio||Standard Deviation|Mean
1380167|NCT01457573|Secondary|Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8|Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin.|Change from baseline to Mo.1/Wk4 and Mo.2/Wk8||||pg/ml||Standard Deviation|Mean
1380168|NCT01457573|Secondary|Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
1380169|NCT01457573|Secondary|Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
1380170|NCT01457573|Secondary|Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
1380171|NCT01457573|Secondary|Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
1380172|NCT01457573|Secondary|Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.|The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
1380173|NCT01457573|Secondary|Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old.|Change from baseline to months 1, 2 and 3||||ml/s||Standard Deviation|Mean
1380174|NCT01457573|Secondary|Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin.|Change from baseline to months 1, 2 and 3||||ml||Standard Deviation|Mean
1380175|NCT01457573|Primary|Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)|The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses.|change from baseline score to Month 3||||ratio||Standard Deviation|Mean
1380176|NCT01457573|Primary|Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12|Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin.|Change from baseline to week 12 (3 months)||||pg/ml||Standard Deviation|Mean
1380177|NCT01457521|Primary|11-point Visual Analog Scale for Pain|Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)|1-2 weeks||||units on a scale||Standard Deviation|Mean
1380178|NCT01457430|Secondary|Percent Change in VAS Scores|Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity|Percent Change in VAS Score from Baseline to 4 Hours||||percent change||Inter-Quartile Range|Median
1380179|NCT01457430|Primary|Time to Complete or Near Complete Resolution From Onset of Symptoms|Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.|Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours||||minutes||Inter-Quartile Range|Median
1380180|NCT01457417|Primary|Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|Patients with advanced NSCLC receiving the study drug at 300 mg every 2 weeks in Part B|||months||95% Confidence Interval|Median
1380181|NCT01457417|Secondary|Objective Response Rate (ORR) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|FAS : For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|FAS : NSCLC - All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. Two patients in treatment group 300 mg Q2W did not have assessments performed after Baseline.|||participants||95% Confidence Interval|Number
1380182|NCT01457417|Secondary|Objective Response Rate (ORR) in Oncologic Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. One Patients from the 300 mg QW treatment group, and two patients from 300 mg Q2W treatment group did not have assessments performed after Baseline.|||Participants||95% Confidence Interval|Number
1380183|NCT01457417|Secondary|Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC|For Part B only. OS was defined as the time from the date of signed informed consent to the date of death from any cause. For patients who were still alive as of the data cut-off date, OS time was censored on the date of the patient’s last contact (last contact for patients in post-discontinuation was the last date of contact in long-term follow-up eCRF).|Time from the date of signed informed consent to the date of death from any cause|For patients who are still alive as of the data cut-off date, OS time will be censored on the date of the patient’s last contact (last contact for patients in post-discontinuation = last Date of Contact in Long Term Follow-up eCRF).|||Months||95% Confidence Interval|Median
1380184|NCT01457417|Secondary|Progression Free Survival (PFS) in Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (i.e, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|All patients who received at least one dose of study treatment during Part A or Part B of the study.|||Months||95% Confidence Interval|Median
1380185|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth dose for QW groups)|All patients who received at least one dose of study treatment during Part A of the study.|||ng/mL||Standard Deviation|Mean
1380186|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the first and fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.|||ng/mL||Standard Deviation|Mean
1380187|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth Dose for QW)|All patients who received at least one dose of study treatment during Part A study.|||hr*ng/mL||Standard Deviation|Mean
1380188|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.|||hr*ng/mL||Standard Deviation|Mean
1380189|NCT01457417|Primary|Summary of Patients With Adverse Events (AE)|Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.|||Patients|||Number
1380190|NCT01457417|Primary|Summary of Total Adverse Events (AE)|Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.|||Events|||Number
1380191|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
1380192|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
1380193|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
1380194|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
1380216|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1384225|NCT01418482|Secondary|Evaluate the Comfort|Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good.|3 weeks||||participants|||Number
1380195|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
1380196|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
1380197|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380198|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380199|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380200|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380201|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380202|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380203|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380204|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380205|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380206|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380207|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380208|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
1380209|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
1380210|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
1380211|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
1380212|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
1380213|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
1380214|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
1380215|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380787|NCT01452152|Secondary|Health Care Resource Utilization and Cost-effectiveness||One year|This outcome measure has zero total participants analyzed because health care resource utilization and cost-effectiveness data was not collected due to the early termination of the trial.||||||
1380217|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380218|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380219|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380220|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380221|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380222|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380223|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380224|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380225|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380226|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380227|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380228|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380229|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380230|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380231|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380232|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380233|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380234|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380235|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380236|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380237|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380238|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380239|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380240|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1384226|NCT01418482|Primary|Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice|burns healed|3 weeks|small thickness partial burns|||burns healed|||Number
1380241|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380242|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380243|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380244|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
1380245|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
1380246|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
1380247|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
1380248|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
1380249|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
1380250|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
1380251|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
1380286|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380252|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
1380253|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
1380254|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
1380255|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380256|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380257|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380258|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380259|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380260|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380261|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380262|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380263|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380264|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
1380265|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
1380266|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
1380267|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
1380268|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
1380269|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
1380270|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
1380271|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
1380272|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380273|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380274|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1380275|NCT01457053|Primary|Myocardial Blood Flow|Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).|1 - 5 days|No data analyzed due to inadequate enrollment.||||||
1380276|NCT01457014|Secondary|Number of Arterial Oxygen Saturation Per Hour|Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)||||times per hour||Standard Deviation|Mean
1380277|NCT01457014|Secondary|Percent Oxygen Saturation|Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)||||percentage of oxygen saturation||Standard Deviation|Mean
1380278|NCT01457014|Primary|Number of Sleep Related Events Per Hour|The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|After the Diagnostic Polysomnography (PSG) each participant completed a night in each arm.|||events/hour||Standard Deviation|Mean
1380279|NCT01456962|Primary|CD4+ to CD8+ T Cell Ratio in Cervical Biopsies|Evaluation of cervical immune health in HIV-infected women on tenofovir (TDF) and emtricitabine (FTC) and either raltegravir or atazanavir. Cervical CD4+ to CD8+ T cell ratios will be measured at one time point from cervical biopsies. Higher ratios will be a measure of better cervical immune health. In addition, ratios will be compared to the concentration of the drug in the genital tract.|12 hours after the last medication dose||||Cervical CD4+:CD8+ T cell ratio||95% Confidence Interval|Geometric Mean
1380280|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence (Overall)|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380281|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Psychiatric History Cohort|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380282|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Non-psychiatric History Cohort|"A responder to this endpoint requires the answer “no” to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380283|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380284|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380285|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380880|NCT01451398|Secondary|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population|||percentage of participants|||Number
1380287|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380288|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort|A responder to this endpoint requires the answer “no” to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).|Week 9 through Week 12|The full analysis set was defined under the intent-to-treat (ITT) principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
1380289|NCT01456936|Secondary|"Clinical Global Impression of Improvement (CGI‑I), No Change Rating by Visit"|"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as normal, not at all ill on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as no change on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs."|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants|||Number
1380290|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Overall|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants with positive responses|||Number
1380291|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants with positive responses|||Number
1380292|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Non-psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants with positive responses|||Number
1380293|NCT01456936|Secondary|HADS Total Score (Overall)|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||Units on a scale||Standard Deviation|Mean
1380294|NCT01456936|Secondary|HADS Total Score, Psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||Units on a scale||Standard Deviation|Mean
1380295|NCT01456936|Secondary|Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||Units on a scale||Standard Deviation|Mean
1380305|NCT01456780|Primary|Corneal Fluorescein Staining Score|Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
1380296|NCT01456936|Secondary|Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)|The NPS AE endpoint was the occurrence of at least 1 treatment-emergent “severe” AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent “severe” AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
1380297|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
1380298|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
1380299|NCT01456936|Secondary|Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants|||Number
1380300|NCT01456936|Secondary|Occurrence of the Components of NPS AE Primary Endpoint (Overall)|The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
1380301|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
1380302|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort|The safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
1380303|NCT01456936|Primary|Estimated NPS AE Rate (%), by Cohort|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants||95% Confidence Interval|Least Squares Mean
1380304|NCT01456936|Primary|Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint|The primary safety endpoint is the occurrence of at least one treatment emergent “severe” adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent “moderate” or “severe” adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants|||Number
1380306|NCT01456780|Primary|Symptom Assessment iN Dry Eye (SANDE) Severity Score|Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient’s dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
1380307|NCT01456780|Primary|Symptom Assessment iN Dry Eye (SANDE) Frequency Score|Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient’s dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
1380308|NCT01456780|Primary|Ocular Surface Disease Index|OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
1380309|NCT01456299|Secondary|Frequency of Apnea|If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group|baseline, 30sec after drug injection|||||||
1380310|NCT01456299|Primary|LMA Insertion Condition|The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.|at that time on LMA insertion only||||participants|||Number
1380311|NCT01456195|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)|The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. MTT were only done at sites that had MTT capabilities.|||mmol/L||Standard Error|Least Squares Mean
1380312|NCT01456195|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.|||mg/dL||Standard Error|Least Squares Mean
1380313|NCT01456195|Secondary|Incidence of HbA1c <7%|The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.|Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. Last Observation Carried Forward.|||percentage of participants|||Number
1380314|NCT01456195|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.|||percent||Standard Error|Least Squares Mean
1380315|NCT01456169|Secondary|Percentage of Participants Who Achieve Both Clinic Systolic and Diastolic Blood Pressure Targets at Week 8|Percentage of participants who achieve both clinic systolic and diastolic blood pressure targets at Week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease) for systolic AND less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease) for diastolic blood pressure.|Week 8|Full analysis set|||percentage of participants|||Number
1380316|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Diastolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic diastolic blood pressure measured at final visit or week 8, defined as less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease). Diastolic blood pressure is based on the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Week 8|Full analysis set|||percentage of participants|||Number
1380317|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Systolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic systolic blood pressure measured at final visit or week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease). Systolic blood pressure is the arithmetic mean of the 3 trough sitting Systolic blood pressure measurements.|Week 8|Full analysis set|||percentage of participants|||Number
1384304|NCT01416584|Other Pre-specified|Did Participant Inject Drugs?|Percent of months that participants reported injecting drugs.|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
1380318|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at final visit or Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380319|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380320|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380321|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380322|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380323|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380324|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380325|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380326|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included|||mm Hg||Standard Error|Least Squares Mean
1380327|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
1380328|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change between trough diastolic blood pressure measured at final visit or week 8 relative to baseline Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8|Full analysis set; LOCF was used.|||mm Hg||Standard Error|Least Squares Mean
1380369|NCT01455545|Secondary|Asthma Severity According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA).~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months||||participants|||Number
1380329|NCT01456169|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline (of the double-blind treatment period) and Week 8|Full analysis set, consisting of all randomized participants who received at least 1 dose of double-blind study drug. A participant was included in the analyses only when there was both a baseline value and at least 1 value during the double-blind treatment period. Last observation carried forward (LOCF) was used.|||mm Hg||Standard Error|Least Squares Mean
1380330|NCT01456143|Primary|Interrater Reliability|Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||proportion of agreement among 11 experts||95% Confidence Interval|Number
1380331|NCT01456143|Primary|Negative Predictive Value|NPV = proportion of those with a negative test without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
1380332|NCT01456143|Primary|Positive Predictive Value|PPV = proportion of those with a positive test who have neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
1380333|NCT01456143|Primary|Specificity|Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
1380334|NCT01456143|Primary|Sensitivity|Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
1380335|NCT01456143|Primary|Accuracy|Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
1380336|NCT01456130|Secondary|Change From Baseline in Fasting Glucose|The change in the value of fasting glucose collected at Week 52 or the final visit relative to Baseline.|Baseline and Week 52|Full analysis set.|||mg/dL||95% Confidence Interval|Mean
1380337|NCT01456130|Secondary|Percentage of Participants With a Clinical Response|Clinical response is defined as an HbA1c level less than 5.8% or less than 6.5% at Week 52 or at the final visit.|Week 52|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1380338|NCT01456130|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin collected at Week 52 or at the final visit relative to Baseline.|Baseline and Week 52|Full analysis set: All randomized participants who received at least one dose of double-blind study medication.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Mean
1380339|NCT01456130|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|52 Weeks|Safety analysis set - All participants who received at least one dose of the investigational product (alogliptin) and a rapid-acting insulin secretagogue.|||participants|||Number
1380340|NCT01456052|Secondary|Change From Baseline in Total Modified Mayo Score|A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- >4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity.|Baseline to 8 weeks||||units on a scale||Standard Deviation|Mean
1380341|NCT01456052|Secondary|Number of Subjects Achieving Clinical Remission|Clinical remission is defined as a total modified Mayo score ≤2 with no individual score >1 at Week 8.|Baseline to 8 weeks||||participants|||Number
1380342|NCT01456052|Secondary|Number of Subjects Achieving Clinical Response|Clinical response is defined as a decrease in the total modified Mayo score from baseline of ≥3 or a ≥30% decrease in the total modified Mayo score from baseline, along with a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1 at Week 8.|Baseline to 8 weeks||||participants|||Number
1380343|NCT01456052|Primary|Number of Subjects Experiencing a Treatment Emergent Adverse Event||8 weeks||||participants|||Number
1380344|NCT01456039|Secondary|Kaplan Meier (K-M) Estimate of Time to Progression (TTP) in PTCL Participants Based on the Modified 2007 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin|||days||95% Confidence Interval|Median
1380817|NCT01451645|Secondary|Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||Percentage of Participants||95% Confidence Interval|Number
1380345|NCT01456039|Secondary|Kaplan Meier Estimate of Time to Progression (TTP) in PTCL Participants Based on the 1999 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin|||days||95% Confidence Interval|Median
1380346|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 2007 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||95% Confidence Interval|Median
1380347|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 1999 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||95% Confidence Interval|Median
1380348|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 2007 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||Full Range|Median
1380349|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 1999 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||Full Range|Median
1380350|NCT01456039|Secondary|Percentage of PTCL Participants With the Best Response in Accordance With the Modified 2007 International Workshop Response Criteria as Assessed by IER|Objective disease response in PTCL was defined as achieving a CR or PR based on the Modified 2007 IWC. A CR = a complete disappearance of all disease; lymph node mass regression to normal size on computerized tomography (CT) scan or negative on positron emission tomography (PET); non-palpable splenic and disappearance of liver nodules; infiltrate cleared on repeat bone marrow (BM), immunohistochemistry negative. PR = a reduction of measurable lesions; ≥ 50% decrease in sum of the products of the greatest diameters (SPD) of up to 6 largest dominant masses, no enlargement in size of other nodes; ≥ 50% decrease in SPD and no increase in liver or spleen.|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin|||percentage of participants||95% Confidence Interval|Number
1380351|NCT01456039|Secondary|The Percentage of Participants With Abnormal Q-wave and T Wave Intervals|The time from the start of the Q-wave to the end of the T-wave QTc intervals greater than 450 msec post-baseline performed by centralized reviewer. The Bazett's (QTcB) and Fridericia (QTcF) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval|Median follow-up: 100 days; up to data cut-off of 28 July 2015|The ECG population includes all participants who received romidepsin on Day 1 of Cycle 1 with at least one post-baseline QTc result|||percentage of participants|||Number
1380352|NCT01456039|Secondary|Cmax Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Cmax of Romidepsin: accumulation ratio based on Cmax calculated as Cmax,ss/Cmax|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at end of administration) hours after the start of administration, 0.25, 0.5, 1, 2, 4, 6, 20, and 44 hours after the end of administration. Day 8, Cycle 1, samples collected at 0 hour|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1380353|NCT01456039|Secondary|AUC0-t, Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point; accumulation ratio calculated as AUC (0-t),ss/AUC (0-t)|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1380354|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1 at Cycle 1, Day 15|The terminal phase half-life of romidepsin after a single dose on Day 15, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Geometric Coefficient of Variation|Geometric Mean
1380818|NCT01451645|Secondary|Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||Percentage of Participants||95% Confidence Interval|Number
1380355|NCT01456039|Secondary|Tmax,ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Observed time to first maximum plasma concentration at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Full Range|Median
1380356|NCT01456039|Secondary|Cmax, ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Maximum observed concentration in plasma at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1380357|NCT01456039|Secondary|AUC0-t, at Steady State (ss) of Romidepsin in Phase 1 at Cycle 1, Day 15|Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1380358|NCT01456039|Secondary|Apparent Volume of Distribution (Vz/F) of Romidepsin in Phase 1|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1380359|NCT01456039|Secondary|Apparent Total Clearance of Romidepsin (CL/F) of Romidepsin in Phase 1|The apparent total clearance of romidepsin after a single dose on Day 1, calculated as dose/AUC0-infinity.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1380360|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1|The terminal phase half-life of romidepsin after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Geometric Coefficient of Variation|Geometric Mean
1380361|NCT01456039|Secondary|Time to Maximum Plasma Concentration of Romidepsin (Tmax) in Phase 1|The time to first maximum observed plasma concentration of romidepsin after a single dose on Day 1.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Full Range|Median
1380362|NCT01456039|Secondary|Maximum Plasma Concentration (Cmax) of Romidepsin in Phase 1|The maximum observed plasma concentration of romidepsin (Cmax) obtained directly from the observed concentration versus time data|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|Pharmacokinetic (PK) Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1380370|NCT01455545|Secondary|Pulmonary Function Test (Spirometry) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry).~Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months||||percentage of the theoretical||Standard Deviation|Mean
1380363|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC∞) of romidepsin on Day 1; if possible the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population consisted of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for romidepsin for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1380364|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1380365|NCT01456039|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.|Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks|Safety population includes all participants who received at least one dose of romidepsin|||participants|||Number
1380366|NCT01456039|Primary|Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2|Objective disease response in PTCL was defined as patients with a complete response (CR), unconfirmed complete response (CRu) or a partial response (PR) according to modified IWC 1999 criteria and assessed by an independent efficacy reviewer. A CR is >75% decrease in size of maximum 6 largest target within nodal and extranodal lesions, complete disappearance of other nodal and extranodal; total disappearance of clinical disease; disease-related signs and symptoms, normalization of biochemical abnormalities, disappearance of spleen, liver, or kidney enlargement; no bone marrow (BM) involvement, no new sites of disease. CRu: all above criteria fulfilled except for BM involvement is indeterminate. PR: a ≥50% decrease in size of 6 largest target lesions and no increase other nodal and extranodal; no progression of clinical disease; disease-related signs and symptoms, normalization or biochemical abnormalities, no progression in size of liver, spleen, or kidney; and no new sites of disease|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of Romidepsin|||percentage of participants||95% Confidence Interval|Number
1380367|NCT01456039|Primary|Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC)|DLT was defined as an adverse event (AE) occurring in Cycle 1 in Phase 1 and judged that the causal relationship to the investigational product could not be denied. The severity of all AEs was graded based upon the NCI CTCAE version 3.0. DLTs were defined as: • Grade 4 Hemoglobin <6.5 g/dL • Grade 4 Neutrophil <500/μL continuing for at least 5 days • Febrile neutropenia (Grade 4 neutropenia caused by fever and ≥ 38.5° C for more than 1 hour) • Grade 4 thrombocyte (< 25,000/μL), or thrombocytopenia with hemorrhage requiring platelet transfusion • Nausea, vomiting, or diarrhea at > grade 3 in spite of treatment • Grade 3 ALT (alanine aminotransferase) or AST (aspartate aminotransferase) values continued for 7 days. • Grade 4 ALT or AST • Grade 2 arrhythmia • Grade 4 non-hematological AEs • Other grade 3 non-hematological AEs except transient fatigue, anorexia, hyponatremia, and tumor lysis syndrome • Other AEs leading to discontinuation of administration|Up to Day 28; Cycle 1|DLT population included all participants in the Phase 1 portion who received at least one dose of romidepsin. Of 8 participants enrolled in the 14mg/m^2 cohort, 2 participants, one with a critical Good Clinical Practice (GCP)violation and the other who did not complete Cycle 1 due to consent withdrawal, were excluded from the DLT assessment.|||participants|||Number
1380368|NCT01456000|Primary|Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description|Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.|1 year||||Successful Participants|||Number
1380387|NCT01455519|Secondary|Change in Sit to Stand Repetitions|Sit to stand repetitions completed in 1 minute|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||number of repetitions||Standard Error|Mean
1380371|NCT01455545|Primary|Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.|"Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks||||participants|||Number
1380372|NCT01455545|Secondary|Concomitant Psychiatric Disorders According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders.~Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks||||participants|||Number
1380373|NCT01455545|Secondary|Gastroesophageal Reflux According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux.~Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks||||participants|||Number
1380374|NCT01455545|Secondary|Sinusitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.~Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group."|4 weeks||||participants|||Number
1380375|NCT01455545|Secondary|Rhinitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis.~Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.~Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline."|4 weeks||||participants|||Number
1380376|NCT01455545|Secondary|Obesity According to Level of Asthma Control.|"Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI > 30 obesity.~Asthma control was measured by Asthma Control test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19 ."|4 weeks||||participants|||Number
1380377|NCT01455545|Secondary|Smoking Habit According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit.~Good control if ACT score > 19. Bad control if ACT score < or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked."|4 weeks||||participants|||Number
1380378|NCT01455545|Secondary|Gender According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender.~Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19."|4 weeks||||participants|||Number
1380379|NCT01455545|Secondary|Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion).~Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks|The same as primary outcome.|||units on a scale (parts per billion)||Inter-Quartile Range|Median
1380380|NCT01455545|Primary|Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.|"The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence.~Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma.~To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers)."|4 weeks||||units on a scale||Inter-Quartile Range|Median
1380381|NCT01455519|Secondary|Change in NRS After Box Lift|Numeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
1380382|NCT01455519|Secondary|Change in NRS After Sit to Stand Repetitions|Numeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
1380383|NCT01455519|Secondary|Change in NRS After Treadmill Walk|Numeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
1380384|NCT01455519|Secondary|Change in NRS After Stair Climb|Numeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
1380385|NCT01455519|Secondary|Change in Time to Lift Box|Time to lift 13 pound box to floor and back up to table.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||seconds per lift||Standard Error|Mean
1380386|NCT01455519|Secondary|Change in Distance to Floor|Distance from fingers to Floor when bending forward. A functional test of flexibility|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||centimeters||Standard Error|Mean
1380390|NCT01455519|Secondary|Change in Pain Disability|The Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
1380391|NCT01455519|Secondary|Change in PASS|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
1380392|NCT01455519|Primary|Change in VAS|Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
1380393|NCT01455519|Primary|Change in McGill Pain Questionnaire – Short Form|The McGill Pain Questionnaire – Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
1380394|NCT01455428|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380395|NCT01455428|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380396|NCT01455428|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Deviation|Mean
1380397|NCT01455428|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant’s perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380398|NCT01455428|Secondary|Clinical Global Impression of Change (CGIC) Score at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician’s perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380399|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380408|NCT01455428|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1380400|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380401|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380402|NCT01455428|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (consisted of all participants randomized to treatment that received at least 1 dose of study medication) with available data to contribute to the analysis.|||percentage of participants|||Number
1380403|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380404|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380405|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380406|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1380407|NCT01455428|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
1380462|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Oral Calcium at Each Visit||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.|||percentage of change||Standard Deviation|Mean
1380463|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit||24 Weeks||||percentage of change||Standard Deviation|Mean
1380409|NCT01455428|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1380410|NCT01455428|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108|||units on a scale||Standard Deviation|Mean
1380411|NCT01455428|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8|SF-MPQ was assessed according to the participant’s answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 3, 5, and 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point.|||units on a scale||Standard Deviation|Mean
1380412|NCT01455428|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|The DPRS consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline.|End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||percentage of participants|||Number
1380413|NCT01455428|Secondary|Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1380414|NCT01455428|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1380415|NCT01455428|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Deviation|Mean
1380416|NCT01455428|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8|The DPRS consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week.|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1380417|NCT01455428|Primary|Change From Baseline in Mean Pain Score at Endpoint|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Error|Least Squares Mean
1380418|NCT01455428|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Deviation|Mean
1380419|NCT01455415|Secondary|PGIC Score at the End of Period 1 (Week 6) - Categorized Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (7 different scores) and categorized scores (4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.|||percentage of participants|||Number
1380420|NCT01455415|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|The daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380421|NCT01455415|Secondary|Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.|||percentage of participants|||Number
1380422|NCT01455415|Secondary|EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 – but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380423|NCT01455415|Secondary|EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 – but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380424|NCT01455415|Secondary|EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380464|NCT01455181|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks||||percentage of participants||95% Confidence Interval|Number
1380425|NCT01455415|Secondary|EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380426|NCT01455415|Secondary|EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380427|NCT01455415|Secondary|EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380428|NCT01455415|Secondary|Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale (no problems, some/moderate problems, extreme problems) and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380429|NCT01455415|Secondary|Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). The autonomic domain score should be summed as follow: Σ (19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 12). The QOL-DN version that was administered in this study was modified with a 2-week recall period.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380430|NCT01455415|Secondary|Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The small fiber domain score should be summed as follow: Σ (10, 16, 17, 18). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of the listed questionnaire items (range: 0 - 16). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380431|NCT01455415|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. With exception of questions 31 and 32, items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, middle item, is scored as 0, “very good” as -1 , “excellent” as -2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. Physical functioning / large fiber domain score should be summed as follow: Σ (8, 11, 13 - 15, 24, 27 - 35). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: -4 - 56). QOL-DN version that was administered in the study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380819|NCT01451645|Primary|Number of Gout Flares Per Participant From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||gout flares||Standard Deviation|Mean
1380432|NCT01455415|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). Activities of the daily living domain score should be summed as follow: Σ (12, 22, 23, 25, 26). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: 0 - 20). The QOL-DN version that was administered in the study was modified with a 2-week recall period.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380433|NCT01455415|Secondary|Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. Item 9 is scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The symptoms domain score should be summed as follow: Σ (1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 32). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380434|NCT01455415|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, “no problem” to “severe problem”). In question 31, “good”, the middle item, is scored as 0, “very good” as -1, “excellent” as -2, “fair” as 1, and “poor” as 2. In question 32, “about the same”, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The (sub)scales are calculated without weighting of any kind, and reported as the integer sum of listed questionnaire items (range: -4 - 136). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380435|NCT01455415|Secondary|HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|HADS is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380436|NCT01455415|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380437|NCT01455415|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates “does not interfere with sleep” and 10 indicates “completely interferes (unable to sleep due to pain)”. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380438|NCT01455415|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Seven sub-questions evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on an 11-point scale (0: does not interfere; 10: completely interferes). Scores range from 0 - 10 with higher scores indicating greater interference.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380439|NCT01455415|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Four items measure pain (0: no pain; 10: worst pain possible) at its “worst, “least”, “average”, and “now” (current pain) on an 11-point scale. Scores range from 0 - 10 with higher scores indicating greater pain severity.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
1380440|NCT01455415|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||percentage of participants|||Number
1380441|NCT01455415|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|Daily pain diary consisted of an 11-point numeric scale ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||percentage of participants|||Number
1380442|NCT01455220|Secondary|Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))|Change in score on the Multiple Sclerosis Quality of Life (MSQOL-54) from end of study compared to baseline. The MSQOL-54 is a 54-item quality of life questionnaire that has general, as well as, MS specific questions covered in 6 sub-categories (mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being). Minimum score of 0 to maximum score of 100. Overall quality of life is calculated by averaging question 53 and 54. The sub-scales( mental and physical health) are on a weighted scale. Sets of questions are totaled and divided by the number of questions in each section then that section total is multiplied by a weighted value. Then all weighted values are summed for all relevant question sections for that subscale to compute a composite score for both mental health and physical health. A higher score, indicates a higher perceived quality of life for the patient. A lower scorer indicates poorer quality of life impacted by MS.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
1380443|NCT01455220|Secondary|Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))|Change in score on the Functional Assessment of MS (FAMS) questionnaire.The FAMS consists of 44 scored items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional well being (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social well being (seven items). Minimum score of 0 to max score of 176. A higher scores indicates positive (better) functional health related quality.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
1380444|NCT01455220|Secondary|Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))|Change in composite score in the sexual function subscale of the Multiple Sclerosis Quality of Life (MSQOL-54) over 6 months of Natalizumab treatment. Minimum score of 0 and max score of 100. A higher score indicates a more positive outcome (less sexual dysfunction).|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
1380445|NCT01455220|Primary|Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )|Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
1380446|NCT01455194|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
1380465|NCT01455064|Primary|Clarke Error Grid Analysis|Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.|15 days sensor wear|One subject was withdrawn due to a mild reaction to the sensor adhesive. This subject's data was included in the study up to the point of withdrawal.|||Percentage of Results|Participants||Number
1380820|NCT01451632|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction|||||||Number
1380447|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
1380448|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP >170 millimeters of mercury (mm Hg) or <85 mm Hg, Diastolic BP >105 mm Hg, resting pulse rate: >120 bpm or <50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment >40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment >30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
1380449|NCT01455194|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
1380450|NCT01455194|Secondary|Number of Participants With Markedly High Benefits|The analyses was intended to identify participant’s subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included.|Week 1 up to Week 52|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
1380451|NCT01455194|Secondary|Number of Participants Reporting Asthma Exacerbations Rates|Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
1380452|NCT01455194|Secondary|Number of Participants Reporting Time to First Asthma Exacerbation|Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
1380453|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point|Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
1380518|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first year of observation period|1 year follow up||||percentage of patients|||Number
1380519|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 3 years||||percentage of patients|||Number
1380454|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
1380455|NCT01455194|Secondary|Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
1380456|NCT01455194|Secondary|Number of Weeks With Well-controlled Asthma Over the Course of the Study|The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||weeks|weeks||Number
1380457|NCT01455194|Secondary|Time Course of ACQ|The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline, Week 52 (Treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||Weeks||Full Range|Median
1380458|NCT01455194|Primary|Change From Baseline in ACQ Score to Tlast|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||units on a scale||Standard Error|Mean
1380459|NCT01455194|Primary|Asthma Control Questionnaire (ACQ) Score at Baseline|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline|The intent-to-treat (ITT) analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||units on a scale||Standard Error|Mean
1380460|NCT01455181|Secondary|Mean Change From Baseline in 24-hour Urine Calcium Excretion||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.|||mg/24 hour||Standard Deviation|Mean
1380461|NCT01455181|Secondary|Proportion of Patients Achieving the Primary Endpoint at Each Visit|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement .|||percentage of participants|||Number
1380466|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 6 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 6 measures subject's tiredness or sleepiness during the day on a 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380467|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 5 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 5 measures the severity of RLS during day not rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 5 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380468|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 4 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 4 measures the severity of RLS during day rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 4 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380469|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 3 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 3 measures the severity of RLS during the night on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 3 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380470|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 2 measures the severity of RLS at time falling asleep on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 2 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380471|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 1 measures subject's satisfaction with sleep on a 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380472|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period|"The CGI Item 3 score measures the therapeutic efficacy on a 4-point scale consisting of the following categories:~1- Very good~2- Moderate~3- Slight~4- Unchanged or worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||participants|||Number
1380473|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period|"The CGI Item 1 score measures the severity of illness on a 7-point scale consisting of the following categories:~1- Normal, not ill at all~2- Borderline ill~3- Mildly ill~4- Moderately ill~5- Markedly ill~6- Severely ill~7- Among the most extremely ill subjects"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||participants|||Number
1380474|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period|"The CGI Item 2 score measures any change in severity of RLS from Baseline on a 7-point scale consisting of the following categories:~1- Very much improved~2- Much improved~3- Minimally improved~4- No change~5- Minimally worse~6- Much worse~7- Very much worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||participants|||Number
1380475|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period|The RLS-QoL is a disease-specific instrument for the evaluation of Quality of life. It consists of 12 items and the overall sum score is calculated from all 12 items and measured on a scale that ranges from 0 (lowest Quality of life) to 60 (highest level of Quality of life). A negative value in RLS-QoL Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380476|NCT01455012|Secondary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period|The IRLS is a subject-based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' daytime functioning. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items was calculated. A negative value in IRLS Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
1380477|NCT01455012|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in PLMI Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||Periodic Limb Movements/hour||Standard Deviation|Mean
1380478|NCT01455012|Secondary|Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.~A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||Nocturnal Elevations of Systolic BP||Standard Deviation|Mean
1380479|NCT01455012|Primary|Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.~A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||Nocturnal Elevations of Systolic BP||95% Confidence Interval|Least Squares Mean
1380480|NCT01454947|Secondary|Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses|We will monitor overall prescribing for the specified diagnoses and other acute respiratory infection diagnoses, including cough/fever and pneumonia.|18 months|||||||
1380481|NCT01454947|Primary|Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses|"Assess inappropriate antibiotic prescribing rates (relative to all practices that did not receive the intervention) for antibiotic-inappropriate acute respiratory tract infection visits and no concomitant reason for antibiotic prescribing. based on the following non-antibiotic-appropriate International Statistical Classification of Diseases, version 9 (ICD-9) diagnoses:~460 Acute nasopharyngitis (common cold)~465 Acute laryngeopharyngitis/acute upper respiratory infection~466 Acute bronchitis~490 Bronchitis not specified as acute or chronic~487 Flu"|18 months|We identified a total of 16,959 non-antibiotic-appropriate acute respiratory infection (ARI) visits. Visits were categorized as inappropriate if there were diagnosis codes for non-specific upper respiratory infections, acute bronchitis, and/or influenza.|||inappropriate prescribing rate|Qualifying ARI visits|95% Confidence Interval|Number
1380482|NCT01454934|Secondary|Objective Response Rate (ORR)|The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method.|Randomization (Day 1) to CR or PR|Full analysis set included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1380483|NCT01454934|Secondary|Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance.|Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months|Full analysis set included all randomized participants.|||Months||95% Confidence Interval|Median
1380484|NCT01454934|Primary|Overall Survival (OS)|The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.|Randomization (Day 1) until date of death from any cause, or 37 months|Full analysis set included all randomized participants.|||Months||95% Confidence Interval|Median
1380485|NCT01454830|Secondary|Acceptability of Study Intervention and Comparative Group|"Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to interview at study termination and debriefing (3 months)"|3 months|"Acceptability rating by participants allocated to interview at study termination and debriefing; self-reported rating for binary response to satisfaction with study experience (yes/no); reported as percentage responding yes; no data available for participants who withdrew or were excluded prior to 3-month visit."|||"percentage of allocated responding yes"|||Number
1380486|NCT01454830|Secondary|Proportion of Participants Who Withdrawal|Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals requested from study|||percentage of participants|||Number
1380487|NCT01454830|Secondary|Proportion of Participants Who Complete Protocol After Allocation|Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals, administrative withdrawals for incomplete protocol procedures due to attrition; does NOT include excluded by a priori determined exclusion criteria for protocol|||percentage of participants|||Number
1380488|NCT01454830|Secondary|Proportion of Sleep Time on CPAP|% of Total Sleep Time (TST) using CPAP|1 week|Randomized participants with complete primary outcome data and secondary outcome data (total sleep time) measured by concurrent wrist actigraphy during first week of PAP treatment|||percentage of TST on PAP||Standard Deviation|Mean
1380489|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|3 months||||hours/night||Standard Deviation|Mean
1380490|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 month||||hours/night||Standard Deviation|Mean
1380491|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 week||||hours/night||Standard Deviation|Mean
1380492|NCT01454791|Secondary|Subject Global Impression at 2 Weeks|"This is a single question: How would you rate your level of comfort with Copaxone injection during the past two weeks? Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad."|2 weeks|The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint|||Likert scale 1-7 (7= best)||Standard Deviation|Mean
1380493|NCT01454791|Primary|Pain Scale at 2 Weeks|0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint|||units on a scale||Standard Deviation|Mean
1380494|NCT01454791|Primary|Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks|patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint|||units on a scale||Standard Deviation|Mean
1380495|NCT01454778|Primary|Rutherford Classification of Peripheral Arterial Disease|"Evidence of stenosis of lower extremity as measured by the Rutherford Classification post revascularization. The ABI and Rutherford Classification will be assessed at 10 months post revascularization with a lower Rutherford score indicating a better outcome.~0 = Asymptomatic, 1 = Mild Claudication, 2 = Moderate Claudication, 3 = Severe Claudication, 4 = Ischemic Rest Pain, 5 = Minor Tissue Loss, 6 = Ulceration or Gangrene"|10 months||||units on a scale||Standard Deviation|Mean
1380496|NCT01454778|Secondary|Number of Serious Adverse Events||Up to 19 months||||Number of SAE's|||Number
1380497|NCT01454778|Secondary|Freedom From Binary Restenosis||10 months||||percentage of participants|||Number
1380498|NCT01454778|Secondary|Freedom From Target Vessel Revascularization Event||up to 10 months||||percentage of participants|||Number
1380499|NCT01454778|Secondary|Freedom From Amputation Event||up to 10 months||||percentage of participants|||Number
1380500|NCT01454778|Primary|Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months|The Ankle-Brachial Index is calculated as a ratio of the ankle blood pressure and the arm blood pressure. The ABI and Rutherford Classification will be assessed at 10 months post revascularization|10 months||||ratio||Standard Deviation|Mean
1380520|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 2 years||||percentage of patients|||Number
1385429|NCT01402128|Secondary|Changes in HDL-C(High Density Lipoprotein-cholesterol)|HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dl||Standard Deviation|Mean
1380501|NCT01454726|Primary|Change in Dizziness Handicap Inventory (DHI) Questionnaire Score|dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0.|0 and 24 hours|Among the 27 participants enrolled in the study, one participant quitted the study before treatment application. Twenty-six patients fulfilled all the procedures and were eligible for the full analysis.|||units on a scale||Standard Deviation|Mean
1380502|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|3 years follow up||||percentage of patients|||Number
1380503|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|2 years follow up||||percentage of patients|||Number
1380504|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|1 year follow up||||percentage of patients|||Number
1380505|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 3 years||||percent change||Standard Deviation|Mean
1380506|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 3 years||||percent change||Standard Deviation|Mean
1380507|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years||||percent change||Standard Deviation|Mean
1380508|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years|Patients with DM or HF and RR measurement at baseline and 3 years follow-up|||percent change||Standard Deviation|Mean
1380509|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years||||percent change||Standard Deviation|Mean
1380510|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years|Patients with RR measurement at baseline and 2 years follow-up|||percent change||Standard Deviation|Mean
1380511|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 1 year||||percent change||Standard Deviation|Mean
1380512|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 2 years||||percent change||Standard Deviation|Mean
1380513|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 2 years||||percent change||Standard Deviation|Mean
1380514|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 1 year||||percent change||Standard Deviation|Mean
1380515|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 1 year||||percent change||Standard Deviation|Mean
1380516|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the three years of observation period|3 years follow up||||percentage of patients|||Number
1380517|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first two years of observation period|2 years follow up||||percentage of patients|||Number
1380523|NCT01454531|Secondary|Change in Immediate Cutaneous Response to Phleum Pratense|Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1|baseline (visit 1) and at 6 weeks (visit 6)|Participants in which results of the Parallel Line Assay are valid|||CTI, Cutaneous Tolerance Index||95% Confidence Interval|Mean
1380524|NCT01454531|Secondary|Change in Phleum Pratense Specific IgG4||baseline (visit 1) and at 6 weeks (visit 6)|Number of subject with valid data in visit 1 and visit 6|||mgA/l||Standard Deviation|Mean
1380525|NCT01454531|Secondary|Change in Phleum Pratense Specific IgE-blocking Factor|"IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of:~IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure"|baseline (visit 1) and at 6 weeks (visit 6)||||arbitrary units||Standard Deviation|Mean
1380526|NCT01454531|Secondary|Frequency of Subjects With Local Adverse Reaction|Frequency of patients with local adverse reactions|6 weeks||||participants|||Number
1380527|NCT01454531|Secondary|Frequency of Subjects With Systemic Reactions|Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)|6 weeks||||participants|||Number
1380528|NCT01454531|Primary|Frequency of Subjects With Adverse Drug Reactions|Frequency of patients with adverse reactions, local or systemic|6 weeks|Subjects treated|||participants|||Number
1380529|NCT01454505|Primary|Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.|||Units on a scale||Standard Deviation|Mean
1380530|NCT01454505|Secondary|Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.|||Units on a scale||Standard Deviation|Mean
1380531|NCT01454505|Primary|Number of Adverse Events in Stage A|Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.|Day 1|This reporting group includes all subjects exposed to test article during Stage A.|||Adverse Events|||Number
1380532|NCT01454414|Secondary|Seroconversion Against a Tick-borne Illness|We will define seroconversion as one in which there is a 4-fold change in Immunoglobulin G class antibody titer between sera at enrollment, sera obtained after one year and/or sera obtained at study's end or between acute and convalescent sera for participants developing an acute illness. The antigens that will be used in the serologic assays include Ehrlichia chaffeensis (which would also detect antibodies to E. ewingii and Anaplasma phagocytophilum) and Rickettsia rickettsii (which would also detect antibodies to other spotted fever group rickettsiae).|Upon enrollment, after the first year, and after the second year|||||||
1380533|NCT01454414|Primary|Work Related Tick Bites|Tick bites are defined as ticks attached to or embedded in the skin|Weekly for two years||||tick bites|||Number
1380534|NCT01454401|Primary|Ulcer Healing Within 20 Weeks|Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.|20 weeks|Number of the patients achieved complete epithelialisation at 20 weeks in the ITT population and in the PP population|||participants|||Number
1380535|NCT01454401|Secondary|Ulcer Healing Within 12 Weeks.|Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population|12 weeks|Complete epithelialisation was achieved in 15 patients (34%) in ITT population and 38% in the PP population|||participants|||Number
1380536|NCT01454284|Secondary|Rapid Assessment of Physical Activity (RAPA)|The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant’s amount and intensity of physical activity, allowing each participant’s aerobic activity level to be categorized as sedentary, underactive, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants’ physical activities that increase strength and improve flexibility. Each participant’s strength and flexibility activity level is then categorized as neither strength nor flexibility activity, either strength or flexibility activity (not both), both strength and flexibility activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, multiplied by 100.|52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data.|||percentage of participants|||Number
1380545|NCT01454284|Secondary|Fasting Blood Glucose (by Participant Self Monitored Blood Glucose Readings)|Fasting blood glucose (FBG) was measured by SMBG pre-morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline FBG as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1380537|NCT01454284|Secondary|Adult Low Blood Sugar Survey|Low Blood Sugar Survey (LBSS) (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert-type scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), visit, treatment-by-visit interaction, and baseline LBSS score as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1380538|NCT01454284|Secondary|European Quality of Life -5 Dimension (EQ-5D-3L)|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an ANCOVA adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), and baseline EQ-5D-3L score as covariates.|up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D-3L data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1380539|NCT01454284|Secondary|Insulin Treatment Satisfaction Questionnaire|Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated measure containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Convenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data are transformed to a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an ANCOVA model adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, and baseline prior basal insulin therapy (insulin glargine/detemir/other) as fixed effects and baseline ITSQ scores as a covariate.|up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
1380540|NCT01454284|Secondary|Basal, Meal Time, and Total Insulin Dose Per Body Weight|Basal insulin dose, meal-time insulin dose (short-acting bolus dose), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each postbaseline visit and stratification variables (baseline HbA1c [≤8.5% and> 8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], and baseline prior basal insulin therapy [insulin glargine/detemir/ other]) as fixed effects.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units/weight/day||Standard Error|Least Squares Mean
1380541|NCT01454284|Secondary|Percentage of Participants With Change in Anti-LY2605541 Antibodies|The percentage of participants with anti-LY2605541 treatment-emergent antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.|26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.|||percentage of participants|||Number
1380542|NCT01454284|Secondary|Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol|Concentrations of cholesterol, HDL-C, and LDL-C, and triglycerides are presented. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L), except for the LDL-C outcome variable], prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable as the fixed effects and participant as a random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1380543|NCT01454284|Secondary|0300 Hours Blood Glucose (BG) to Fasting BG Excursion|Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only excursions within a single SMBG profile are included). LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline excursion as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1380544|NCT01454284|Secondary|Intra-participant Variability of Fasting Blood Glucose (FBG)|FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation (SD) of FBG. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline SD of FBG as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1380566|NCT01454063|Secondary|Ocular Pain VAS Score After Day of Surgery - Day 1|Pain VAS scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time-point.|One day|Number of subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1380546|NCT01454284|Secondary|Fasting Serum Glucose (by Laboratory Measurement)|Fasting serum glucose (FSG) is measured in blood before the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1380547|NCT01454284|Secondary|9 Point Self-monitored Blood Glucose (SMBG)|9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, and 52. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline BG values as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
1380548|NCT01454284|Secondary|Change in Body Weight|LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline body weight as fixed effects and participant as the random effect.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
1380549|NCT01454284|Secondary|Percentage of Participants With Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as events associated with the reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
1380550|NCT01454284|Secondary|Nocturnal Hypoglycemia Rates|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||events/participant/30 days||Standard Error|Mean
1380551|NCT01454284|Secondary|Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as events associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.|up to 26 weeks, up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
1380552|NCT01454284|Secondary|Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0%|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|up to 26 weeks, up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
1380553|NCT01454284|Secondary|Percentage of Participants With Total Hypoglycemic Events|Hypoglycemic episodes are defined as events that are associated with the reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
1380554|NCT01454284|Secondary|Total Hypoglycemia Events|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
1380830|NCT01451554|Secondary|Weight Change at 3 Months|Percentage change in weight at 3 months post study baseline|3 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.|||percentage||Standard Deviation|Mean
1380555|NCT01454284|Secondary|Change From Baseline to 52 Weeks in HbA1c|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|Baseline, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1380556|NCT01454284|Secondary|Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant’s average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1380557|NCT01454284|Primary|Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant’s average blood glucose level over a 2 to 3 month timeframe. Least squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, stratification factors (country, baseline low density lipoprotein cholesterol [LDL-C] [<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter [mmol/L]) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
1380558|NCT01454258|Primary|Number of Different Substitution Solutions Administered||24h|Surgical patients from 10 hospitals over a period of 13 months|||participants|||Number
1380559|NCT01454076|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.|||hours||Full Range|Median
1380560|NCT01454076|Secondary|Percentage of Participants With Best Overall Response|Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 millimeter [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, Progressive Disease (PD). An increase of >=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest) represents PD.|Baseline up to end of treatment (approximately 1.9 years)|The response-evaluable population included participants who had measurable disease at baseline, received at least 1 dose of any study drug, and had at least 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1380561|NCT01454076|Secondary|Number of Participants With Clinically Significant Vital Sign Abnormalities||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45|The safety population included all participants who received at least one dose of any study drug.|||participants|||Number
1380562|NCT01454076|Secondary|Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45|The safety population included all participants who received at least one dose of any study drug.|||participants|||Number
1380563|NCT01454076|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45)|The safety population included all participants who received at least one dose of any study drug.|||participants|||Number
1380564|NCT01454076|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.|||nanogram*hour per milliliter (ng*hr/mL)]||Standard Deviation|Geometric Mean
1380565|NCT01454076|Primary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hours[hrs])post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The pharmacokinetic (PK)-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1380831|NCT01451541|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12||||percentage of subjects|||Number
1380567|NCT01454063|Secondary|Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1|"The mean SOIS summarized by treatment arm and time point on Day 1 postoperatively. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with score at time point.|||units on a scale||Standard Deviation|Mean
1380568|NCT01454063|Secondary|Best Corrected Visual Acuity (BVCA) Log Score on Day 1|Best-Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day|Subject who could read well enough to obtain visual acuity score.|||Log score||Standard Deviation|Mean
1380569|NCT01454063|Secondary|Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at Day 1 postoperatively|One day|Subjects with scores at time point.|||participants|||Number
1380570|NCT01454063|Secondary|Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at 6 hours postoperatively.|Six hours postoperatively|Subjects with scores at time point.|||participants|||Number
1380571|NCT01454063|Secondary|Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively|The primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) was based on the mean area-under-the-curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hours. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours|Subjects with scores at time points.|||units on a scale||Standard Deviation|Mean
1380572|NCT01454063|Primary|Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery|"Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute).~The primary analysis of the change in pupil diameter was based on the mean area-under-the-curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC."|from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.|||mm||Standard Deviation|Mean
1380573|NCT01453998|Primary|Concentrations for Anti-Pertussis Toxoid.||One month after the booster dose||2020-12-31|12/2020||||
1380574|NCT01453998|Primary|Concentrations for Anti-poliovirus Types 1, 2 and 3||One month after the booster dose||2020-12-31|12/2020||||
1380575|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-Pertussis Toxoid.||One month after the booster dose||2020-12-31|12/2020||||
1380576|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3.||One month after the booster dose||2020-12-31|12/2020||||
1380577|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380578|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380579|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380580|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380832|NCT01451541|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12||||participants|||Number
1380581|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380582|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380583|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380584|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
1380585|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
1380586|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
1380587|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
1380588|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
1380589|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
1380590|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
1380833|NCT01451541|Secondary|Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12||||percentage of subjects|||Number
1380834|NCT01451541|Secondary|Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12||||participants|||Number
1380591|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
1380592|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
1380593|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
1380594|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
1380595|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
1380596|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
1380597|NCT01453946|Primary|Adverse Event|Any kind of adverse event|16 weeks|Safety analysis set|||Subjects|||Number
1380598|NCT01453946|Secondary|IMPACT 3|IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE|12 weeks|Safety analysis set|||Score units||Standard Deviation|Mean
1380599|NCT01453946|Secondary|PCDAI|Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
1380600|NCT01453894|Primary|Completion of a Fecal Occult Blood Test (FOBT)|This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.|within 6 months of randomization||||participants|||Number
1380601|NCT01453855|Primary|Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)|As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)|The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
1380602|NCT01453725|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.|Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2|The APaT population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.|||Percentage of Participants|||Number
1380719|NCT01453049|Secondary|Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Percent change from Baseline in hs-CRP was calculated as the value at Visit 8 (Wk 24)/ EW minus the value at Baseline divided by value at Wk 24/ EW multiplied by 100.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||percent change||Full Range|Median
1380603|NCT01453725|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.|Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)|The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.|||Percentage of Participants|||Number
1380604|NCT01453725|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16|Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1, who completed Part 1, and who had Baseline and Week 16 MRI SI joint measurements.|||Score on a Scale||Standard Deviation|Mean
1380605|NCT01453725|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Week 16|ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.|||Percentage of Participants|||Number
1380606|NCT01453725|Secondary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16|The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1 and had a Baseline BASDAI assessement.|||Percentage of Participants|||Number
1380607|NCT01453725|Secondary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.|||Percentage of Participants|||Number
1380608|NCT01453725|Primary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.|Week 16|The Full-Analysis-Set (FAS) population consisted of all randomized participants who received at least one dose of study drug in Part 1.|||Percentage of Participants|||Number
1380609|NCT01453595|Primary|Objective Response Rate (ORR)|In patients with advanced clear cell RCC, progressing after prior first-line or second-line mTOR therapy. The determination of antitumor efficacy will be based on objective tumor assessments made according to the RECIST1.1.|1 year|ORR was only assessed for participants who completed the study, which were only 5 patients on Cohort -1|||participants|||Number
1380610|NCT01453569|Secondary|Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.|||units on a scale||Standard Error|Mean
1380860|NCT01451424|Secondary|Endometrial Thickness|Percent change in median endometrial thickness from baseline to end of treatment assessed by ultrasound determination of uterine stripe.|12 or 16 weeks|Safety population, data based on subjects with both baseline and end of treatment assessments|||Percent change||Full Range|Median
1380611|NCT01453569|Secondary|Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.|||units on a scale||Standard Error|Mean
1380612|NCT01453569|Secondary|Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse.|24 weeks||||participants|||Number
1380613|NCT01453569|Primary|Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.|||units on a scale||Standard Error|Mean
1380614|NCT01453413|Secondary|Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)|||percentage of subjects||95% Confidence Interval|Number
1380615|NCT01453413|Primary|Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)|||percentage of subjects||95% Confidence Interval|Number
1380616|NCT01453387|Secondary|Percentage of Subjects With Clinical Benefit|Clinical benefit was to be confirmed by CR, PR or stable disease (SD) lasting at least 6 weeks (using RECIST v1.0) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Every 6 Weeks until complete response or till data cut-off date 15 July 2013|The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.|||percentage of subjects|||Number
1380617|NCT01453387|Secondary|Percentage of Subjects With Overall Response|Overall response was to be confirmed by complete response (CR) or partial response (PR) using response evaluation criteria in solid tumours Version 1.0 (RECIST) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline.|Every 6 Weeks until complete response or till data cut-off date 15 July 2013|The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.|||percentage of subjects|||Number
1380618|NCT01453387|Secondary|Extracellular Signal-regulated Kinase (ERK) Phosphorylation Levels|ERK phosphorylation levels were to be assessed in peripheral blood mononuclear cells (PBMC) during the dose escalation|Schedule 1: Day 1: Pre-dose; Post-dose: 2, 4, 8, 24 hour; 48 or 72 hour; 48 or 96 hour, 168 hour; Day 15: Pre-dose; Schedule 2: Day 1: Pre-dose; Post-dose: 2, 8, 24, 48, 96 hour; Day 15: Pre-dose; Day 17: Pre-dose; Post-dose: 2, 8, and 24 hour|As the trial was terminated early due to administrative reason, it was decided as per Statistical Analysis Plan not to evaluate the biomarker data for this study.||||||
1380619|NCT01453387|Secondary|Apparent Volume of Distribution Associated to the Terminal Phase (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and who provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Liter||Full Range|Geometric Mean
1380881|NCT01451398|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24|||Liters||Standard Deviation|Mean
1380620|NCT01453387|Secondary|Apparent Oral Clearance of the Drug From Plasma (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.|"Pharmacokinetic analysis set included all the subjects who have received at least one dose of MSC2015103B and who have provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. N signifies the total number of subjects evaluable for this outcome measure."|||Liter/hour||Full Range|Geometric Mean
1380621|NCT01453387|Secondary|AUC Versus Time Curve Within One Dosing Interval (AUC0-tau)||Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||hours*picogram/milliliter||Full Range|Geometric Mean
1380622|NCT01453387|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-inf])|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who have received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Hour*picogram/milliliter||Full Range|Geometric Mean
1380623|NCT01453387|Secondary|Apparent Terminal Half Life (T1/2)|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose.n signifies the number of subjects evaluable for the particular timepoint."|||Hour||Full Range|Geometric Mean
1380624|NCT01453387|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Hour||Full Range|Geometric Mean
1380625|NCT01453387|Secondary|Maximum Plasma Concentration (Cmax)||Schedule 1 : 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Days 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Picogram per milliliter||Full Range|Geometric Mean
1380626|NCT01453387|Secondary|Number of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication|Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Subjects|||Number
1380627|NCT01453387|Secondary|Percentage of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication|Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Percentage of subjects|||Number
1380628|NCT01453387|Secondary|Percentage of Subjects Who Experienced Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE (Serious adverse event) is defined as any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.. TEAEs are events between first dose of study drug up to the cut-off date (15 July 2013) and were absent before treatment or that worsened relative to pretreatment state.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Percentage of subjects|||Number
1380629|NCT01453387|Primary|Percentage of Subjects Who Experienced DLT|DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to PD at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.|Up to Day 21 of Cycle 1|Safety analysis set included all subjects who received at least one administration of the trial medication.|||Percentage of subjects|||Number
1380630|NCT01453387|Primary|Number of Subjects Who Experienced Dose-limiting Toxicities (DLT)|DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to progressive disease (PD) at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.|Up to Day 21 of Cycle 1|Safety analysis set included all the subjects who received at least one administration of the trial medication.|||Subjects|||Number
1380631|NCT01453374|Secondary|Criminal Activity|Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants with criminal activity|||Number
1380632|NCT01453374|Secondary|Cocaine Use|Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL|||participants who used cocaine|||Number
1380633|NCT01453374|Secondary|Opioid Dependence|Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence|7 months|||||||
1380634|NCT01453374|Secondary|Opioid Craving|Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.|8 months|All subjects with non-missing data who received at least 1 injection of VIVITROL|||units on a scale||Standard Deviation|Mean
1380635|NCT01453374|Secondary|Retention in the Community|Number of subjects who received all 6 post-release VIVITROL injections|6 months|All subjects who received at least 1 injection of VIVITROL|||participants received all 7 injections|||Number
1380636|NCT01453374|Secondary|Drug Abuse Treatment Program Entry|Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants who entered drug treatment|||Number
1380637|NCT01453374|Secondary|Opioid Overdose|"Number of subjects who overdosed during the study; measured through reported AEs of overdose and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times."|7 months|All subjects who received at least 1 injection of VIVITROL|||participants who overdosed|||Number
1380638|NCT01453374|Secondary|Opioid Use|Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.|7 months|All subjects with non-missing data who had at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants with positive opioid use|||Number
1380639|NCT01453374|Secondary|Incidence of Subject Re-incarceration|Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants re-incarcerated|||Number
1380640|NCT01453374|Primary|Incidence of Subject Re-arrest|Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants re-arrested|||Number
1380641|NCT01453361|Secondary|Number of Alive Subjects|The survival status in patients with stages IIIc and IV melanoma treated with Vigil™ vaccine was determined by following these patients up to 3 years.|3 years|18 subjects were consented but only 8 were administered Vigil treatment (10 screen-failed). These 8 subjects were followed for survival up to 3 years after Vigil treatment.|||Participants|||Count of Participants
1380642|NCT01453361|Primary|Enzyme-Linked ImmunoSorbent Spot (ELISPOT)|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until EOT (30 days after last dose).|Baseline, End of Treatment (30 days after last dose) up to 12 months|18 subjects were consented but only 8 subjects were administered Vigil treatment (10 screen-failed). 7 completed treatment (ELISPOT done) while 1 subject died soon after baseline (ELISPOT not done). After 12 months, 7 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
1380643|NCT01453348|Secondary|Percentages of Subjects With Unsolicited Adverse Events (AEs)|Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).|Day 1 to day 57.|Analysis was done on safety set- subjects who provided any post-baseline safety data.|||percentage of subjects|||Number
1380644|NCT01453348|Secondary|hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29|Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.|28 days post vaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.|||Titers||95% Confidence Interval|Geometric Mean
1380720|NCT01453049|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Change from Baseline in hs-CRP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||mmol/L||Standard Deviation|Mean
1380645|NCT01453348|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29|"Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.~For a subject with a baseline hSBA titer < 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days postvaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.|||percentage of subjects||95% Confidence Interval|Number
1380646|NCT01453348|Secondary|Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination|Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination.|28 days post primary or booster vaccination.|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.|||percentage of subjects||95% Confidence Interval|Number
1380647|NCT01453348|Primary|Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination|Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.|Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.|Analysis was done on Per Protocol (PP) population who provided evaluable serum samples and whose assay results were available at the relevant time points, and had no major protocol deviations|||Concentrations (mIU/mL)||95% Confidence Interval|Geometric Mean
1380648|NCT01453296|Primary|Weighted Mean QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia’s formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds||Standard Error|Least Squares Mean
1380649|NCT01453296|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 1 and Day 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed.|||micrograms||Standard Deviation|Mean
1380650|NCT01453296|Secondary|Total Emitted Dose (TED) on Day 1 and Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|||micrograms||Standard Deviation|Mean
1380651|NCT01453296|Secondary|Peak Pressure Drop on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilopascal (kpa)||Standard Deviation|Mean
1380882|NCT01451398|Secondary|Time to Rescue|Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment|Baseline to Week 24|Full analysis set|||Days||Full Range|Median
1380652|NCT01453296|Secondary|Inhaled Volume on Day 1 and Day 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg."|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
1380653|NCT01453296|Secondary|Inhalation Time on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Seconds (sec)||Standard Deviation|Mean
1380654|NCT01453296|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
1380655|NCT01453296|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (centimeters cubed [cm^3]) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||cm^3||Standard Deviation|Mean
1380656|NCT01453296|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters (cm)||Standard Deviation|Mean
1380657|NCT01453296|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters squared (cm^2)||Standard Deviation|Mean
1380883|NCT01451398|Secondary|Proportion of Subjects Requiring Rescue Therapy||Baseline to Week 24|Full analysis set|||percentage of participants|||Number
1393714|NCT01323270|Primary|Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen||1 month after Vaccination 1||||percentage of participants|||Number
1380658|NCT01453296|Secondary|Blood Glucose and Potassium on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. . Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1380659|NCT01453296|Secondary|Tmax, t1/2, and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, t1/2 is defined as the time required to reduce the plasma concentration to one half its initial value, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
1380660|NCT01453296|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1380661|NCT01453296|Secondary|AUC(0-t) and AUC(0-8) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 8 hours AUC(0-8) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 14 of the respective treatment period (up to Study Day 49)|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzee. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
1380662|NCT01453296|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia’s formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds||Standard Error|Least Squares Mean
1380663|NCT01453296|Primary|Weighted Mean Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Error|Least Squares Mean
1380664|NCT01453296|Primary|Maximum Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Error|Least Squares Mean
1380665|NCT01453296|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, Day 8, and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1, Day 8, and Day 14 of the respective treatment period. PD=post-dose. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1380666|NCT01453296|Primary|Peak Expiratory Flow on Day 1, Day 8, and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||liters/minute||Standard Deviation|Mean
1380667|NCT01453296|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1380668|NCT01453296|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1380669|NCT01453296|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
1380670|NCT01453296|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1380671|NCT01453296|Primary|Mean Corpuscle Hemoglobin (MCH) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
1380672|NCT01453296|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
1380673|NCT01453296|Primary|Hematocrit Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||proportion of 1||Standard Deviation|Mean
1380861|NCT01451424|Secondary|Induction of Amenorrhea at End of Treatment|"Percentage of subjects with induced amenorrhea during last 28 days on drug~Amenorrhea was deemed to be achieved if no daily bleeding score was greater than 1 during the last 28 calendar days of the dosing period. A score of 1 was to be indicated if spotting was observed which did not require a sanitary product. Subjects that terminated early were deemed not to have achieved amenorrhea."|End of treatment||||Percentage of particpants|||Number
1380674|NCT01453296|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1380675|NCT01453296|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1380676|NCT01453296|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1380677|NCT01453296|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 8)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
1380678|NCT01453205|Secondary|Half-life (T1/2) of MEDI-551|Terminal elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Cycle 1 and EOT (Day 21 of Cycle 3 [each cycle of 21 days] or earlier cycles if treatment stopped before Cycle 3)|Participants who received MEDI-551 were analyzed for this end point.|||Day||Standard Deviation|Mean
1380679|NCT01453205|Secondary|Mean Serum Concentration of MEDI-551|The mean serum concentration of MEDI-551 were observed.|Cycle 1 Day -7 Post dose, pre-dose and postdose on Day 1, post-dose on Days 4, 8, 15 of Cycle 1, pre-dose and postdose on Day 1 of Cycle 2 and Cycle 3|Participants who received MEDI-551 were analyzed for this end point.|||mcg/mL||Standard Deviation|Mean
1380680|NCT01453205|Secondary|Number of Participants Who Developed Detectable MEDI-551 Anti-drug Antibodies (ADA)|A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study.|7 days before the start of Cycle 1, Day 1 of each subsequent Cycle, EOT, and post EOT on Days 30, 60, 90 and 270 (up to 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
1380681|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and ECG Abnormalities|Vital signs included parameters such as heart rate, blood pressure, temperature, and respiratory rate. An abnormal vital signs and ECG findings that was judged by the investigator to be clinically significant was reported an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
1380682|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Chemistry Laboratory Results (Include Urinalysis)|An abnormal laboratory findings that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
1380683|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Hematology/Coagulation Laboratory Results|An abnormal laboratory finding that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment (EOT).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
1380862|NCT01451424|Secondary|Uterine Fibroid Size|Percent change in volume of confirmed uterine fibroids at end of treatment, assessed by MRI|12 or 16 weeks|MITT population|||Percentage change||Full Range|Median
1380684|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. Serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
1380685|NCT01453205|Secondary|Acceptable Dose of MEDI-551|Acceptable dose for MEDI-551 was evaluated based on the benefit-risk analysis.|After the administration of the first dose of MEDI-551 (7 days before the Cycle 1) to last dose of MEDI-551 (Cycle 3 Day 1) (each cycle of 21 days)|All participants who were randomized into the study and received MEDI-551.|||milligram per kilogram (mg/kg)|||Number
1380686|NCT01453205|Secondary|Number of Participants With Best Overall Response Assessed by Blinded Independent Central Review (BICR)|The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: CR, PR, stable disease (SD), PD, and unknown. Responses were assessed according to the International Working Group criteria. CR: disappearance of all evidence of disease; PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|ITT population included all participants who were randomized into the study.|||Participants|||Count of Participants
1380687|NCT01453205|Secondary|Duration of Response (DR)|Duration of Response (DR) is defined as time from start of first documented objective response (confirmed CR or confirmed PR) to first documented PD according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules. PD: appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or > 50% increase from nadir in the SPD of any previous lesions. Only participants who have achieved objective response assessed by investigator were evaluated. DR calculated as (months) = (Date of PD or censoring – Date of first disease response + 1)/ (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|"Intent-To-Treat population included all participants who were randomized into the study. Here, N is number of participants analyzed for this outcome measure."|||months||95% Confidence Interval|Median
1380688|NCT01453205|Secondary|Time to Response (TTR)|Time to response (TTR) is defined as the time from randomization until the first documentation of disease response according to the International Working Group criteria. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules. TTR (months) = (Date of first disease response – Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|"ITT population included all participants who were randomized into the study. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
1380689|NCT01453205|Secondary|Time to Progression (TTP)|Time to Progression (TTP) is defined as the time from randomization until the first documentation of PD according to the International Working Group criteria. PD is defined as appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions. TTP (months) = (Date of PD or censoring – Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||Full Range|Median
1380690|NCT01453205|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause according to the International Working Group criteria. OS (months) = (Date of death or censoring – Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||95% Confidence Interval|Median
1380691|NCT01453205|Secondary|Event-Free Survival (EFS)|Event-Free Survival (EFS) is defined as the time from randomization until the first documentation of EFS events which include PD, initiation of alternative antitumor treatment or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions. EFS (months) = (Date of EFS or censoring – Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||Full Range|Median
1380863|NCT01451424|Secondary|Blood Levels of Proellex|Determination of Cmax of Proellex at end of treatment|12 or 16 weeks|Subjects with end of treatment PK assessment|||ng/dL||Standard Deviation|Mean
1380864|NCT01451424|Primary|Change From Baseline in Vaginal Bleeding|"Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period~Less blood loss represents an improvement."|12 or 16 weeks|MITT population|||mL||Full Range|Median
1380692|NCT01453205|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization until the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions. PFS (months) = (Date of PD/death or censoring – Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||Full Range|Median
1380693|NCT01453205|Primary|Objective Response Rate (ORR)|Objective Response Rate is defined as the proportion of participants with a best response of complete response (CR) or partial response (PR) according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50 percent (%) decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant nodal masses and greater than or equal to (>=) 50% decrease in SPD of spleen/liver nodules.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
1380694|NCT01453166|Secondary|Blood Glucose|Change From Baseline in blood glucose|12 weeks|Participants who were evaluable at this time point were analyzed|||mg/dl||Standard Error|Mean
1380695|NCT01453166|Secondary|Waist Circumference|Change From Baseline in wais circumference|12 weeks|Participants who were evaluable at this time point were analyzed|||cm||Standard Error|Mean
1380696|NCT01453166|Primary|Total Cholesterol|Change From Baseline in total Cholesterol|12 weeks|Participants who were evaluable at this time point were analyzed.|||mg/dl||Standard Error|Mean
1380697|NCT01453166|Secondary|Weight|Change From Baseline in weight|12 weeks|Participants who were evaluable at this time point were analyzed|||kg||Standard Error|Mean
1380698|NCT01453166|Primary|Systolic Blood Pressure|Change From Baseline in systolic blood pressure|12 weeks|Participants who were evaluable at this time point were analyzed|||mmHg||Standard Error|Mean
1380699|NCT01453075|Primary|Effect of HSV-2 Suppression on HCV Viral Load.|Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo|baseline; 12 weeks|Analyzed patients who completed study|||log(IU/mL)||Standard Error|Mean
1380700|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW|PR, QT, QTc, RR, QRS, and QRS axis data were measured by ECG. The PR interval (int.) starts at the beginning of the atrial contraction and ends at the beginning of the ventricular contraction. QT (QT int.) and QTc (corrected QT int.) indicate how fast the ventricles are repolarized, becoming ready for a new cycle. The RR int. represents the duration of the ventricular cardiac cycle and is an indicator of ventricular rate. QRS (QRS duration) indicates how fast the ventricles depolarize. The QRS axis is an indicator of the electrical heart axis, which is an average of all heart depolarization.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||milliseconds (msec)||Standard Deviation|Mean
1380701|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Assessment of Heart Rate at Week 24/EW|Electrocardiograms of the participants were taken for the evaluation of heart rate. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||bpm||Standard Deviation|Mean
1380702|NCT01453049|Secondary|Change From Baseline in Weight at Week 24/EW|The weight of the participants was measured. Change from Baseline in weight was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||kilograms (kg)||Standard Deviation|Mean
1380703|NCT01453049|Secondary|Change From Baseline in Heart Rate at Week 24/EW|The heart rate of the participants was measured. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||beats per minute (bpm)||Standard Deviation|Mean
1380704|NCT01453049|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24/EW|The blood pressure of the participants was measured. Change from Baseline in SBP and DBP was calculated as the value at Weeks 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1380705|NCT01453049|Secondary|Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW|Blood samples of participants were collected for TB, DB, creatinine, and UC assessment. Change from Baseline in TB, DB, creatinine, and UC was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Micromoles per liter (mcmol/L)||Standard Deviation|Mean
1380706|NCT01453049|Secondary|Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW|Blood samples of participants were collected for ALT, AST, GGT, LDH, ALP, and CK assessment. Change from Baseline in ALT, AST, GGT, LDH, ALP, and CK was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Units per liter (U/L)||Standard Deviation|Mean
1380865|NCT01451411|Secondary|Population Pharmacokinetics: Volume of Distribution (Vd)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median Vd|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.||||||
1385430|NCT01402128|Secondary|Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)|LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dl||Standard Deviation|Mean
1380707|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Week 24/EW|Blood samples of participants were collected for MCH assessment. Change from Baseline in MCH was calculated as the value at Week 24/EW minus the value at Baseline. MCH is the average amount of hemoblobin inside a RBC expressed in picograms. MCH is calculated by dividing the hemoglobin concentration in grams per deciliter by the RBC count in millions per microliter, then multiplying by 10. MCH is one of the three main RBC indices which are helpful to determine the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Picograms (pg) per cell||Standard Deviation|Mean
1380708|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV) at Week 24/EW|Blood samples of participants were collected for MCV assessment. Change from Baseline in MCV was calculated as the value at Week 24/EW minus the value at Baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the RBC count in millions per microliter of blood, then multiplying by 10. MCV is one of the three main RBC indices that are helpful in determining the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Femtoliters (FL) per cell||Standard Deviation|Mean
1380709|NCT01453049|Secondary|Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW|Blood samples of participants were collected for HE, MCHC, and TP assessment. Change from Baseline in HE, MCHC, and TP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Grams per liter (G/L)||Standard Deviation|Mean
1380710|NCT01453049|Secondary|Change From Baseline in Hematocrit (HCT) at Week 24/EW|Blood samples of participants were collected for HCT assessment. Change from Baseline in HCT was calculated as the value at Week 24/EW minus the value at Baseline. HCT is measured as the percentage of the volume of whole blood that is made up of red blood cells.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||percentage of volume of whole blood||Standard Deviation|Mean
1380711|NCT01453049|Secondary|Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW|Blood samples of participants were collected for lymphocyte, monocyte, neutrophil, eosinophil, and basophil assessment. Change from Baseline in lymphocytes, monocytes, neutrophils, eosinophils, and basophils was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||percent of WBC count||Standard Deviation|Mean
1380712|NCT01453049|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 24/EW|Blood samples of participants were collected for RBC count assessment. Change from Baseline in RBC count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Pico per liter (10^12/ L) cells||Standard Deviation|Mean
1380713|NCT01453049|Secondary|Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW|Blood samples of participants were collected for WBC count and platelet count assessment. Change from Baseline in WBC count and platelet count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Giga per liter (10^9/L) cells||Standard Deviation|Mean
1380714|NCT01453049|Secondary|Number of Participants With a Bone Fracture|Participants with a break in the continuity (fracture) of the bone were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1380715|NCT01453049|Secondary|Number of Hypoglycemic Events|A hypoglycemic event is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants, participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Hypoglycemic events|||Number
1380716|NCT01453049|Secondary|Number of Participants With Hypoglycemic Events|Blood samples of participants were collected for the assessment of blood glucose levels. Hypoglycemia is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants; participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1380717|NCT01453049|Secondary|Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW|In diabetic participants, QOL, anxiety, and depression were measured by the A-DQOL scale . There are 46 core items (10 additional items for adolescents) and 4 major dimensions: treatment satisfaction, treatment impact, worry about long-term complications, and worry about social/vocational issues. Participants respond to all items on a 5-point Likert scale: 1, no impact, no worries, or always satisfied; 5, always affected, always worried, or never satisfied. The total score is a sum of the individual scores of all 46 items (range of 46 to 230); a lower score indicates a better QOL.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1380718|NCT01453049|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW|EQ-5D is used as a measure of health outcome and includes single-item measures (coded on a 3-point scale [1, no problems; 2, some problems; 3, severe problems]) of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument includes a global rating of current health using a visual analog scale (VAS): 0 (worst imaginable) to 100 (best imaginable). Health states may be converted to a single summary index by applying a formula that attaches values to each of the levels in each dimension. The index scale is -0.111 to 1. A lower index indicates worse health.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1380721|NCT01453049|Secondary|Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C and LDL-C) assessment. The ratio of TC/HDL-C and LDL-C/HDL-C was calculated. Change from Baseline in the ratio of TC/HDL-C and LDL-C/HDL-C was calculated as the value at Week 24/EW minus the value at Baseline. For TC/HDL-C, the numerator is TC, and the denominator is HDL-C. For LDL-C/HDL-C, the numerator is LDL-C, and the denominator is HDL-C.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Standard Deviation|Mean
1380722|NCT01453049|Secondary|Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW|Blood samples of participants were collected for BUN and electrolyte (sodium, potassium, chloride, calcium, and phosphorus) assessment. The electrolyte balance asseses the condition of the heart and the kidneys, and BUN assesses the condition of the kidneys. Change from Baseline in BUN, sodium, potassium, chloride, calcium, and phosphorus was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population: all participants who received at least one dose of study medication. Only those participants contributing data at the indicated time points were analyzed.|||mmol/L||Standard Deviation|Mean
1380723|NCT01453049|Secondary|Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C, LDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Change from Baseline in TC, HDL-C, LDL-C, and TG was calculated as the value at Week 24)/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||mmol/L||Standard Deviation|Mean
1380724|NCT01453049|Secondary|Number of Participants at Various Dose Levels at Week 24/EW|The number of participants at the different dose levels at Week 24/EW was recorded. The different dose levels for Rosi + Glim are: Dose level 1, Rosi 4 mg + Glim 1 mg; Dose level 2, Rosi 4 mg + Glim 2 mg; Dose level 3, Rosi 4 mg + Glim 4 mg. The different dose levels for Glim are: Dose level 1, Glim 1 mg; Dose level 2, Glim 2 mg; Dose level 3, Glim 4 mg.|Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed. Data were missing for one participant in the rosiglitazone+glimepiride FDC arm.|||participants|||Number
1380725|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-B is calculated using the following mathematical model to predict glucose and insulin concentrations=(20*FI[mU/ml])/(FG[mmol/l]-3.5).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||Ratio: 20*FI (num.); FG-3.5 (denom.)||Standard Deviation|Mean
1380726|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW|Blood samples of participants who had fasted for 12-14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-S is calculated using the following model to predict glucose and insulin concentrations=(FI[milliunits (mU)/milliliter (ml)]*FG [millimoles per liter (mmol/l)])/22.5. numerator, num.; denominator, denom.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||Ratio: FI*FG (num.); 22.5 (denom.)||Standard Deviation|Mean
1380727|NCT01453049|Secondary|Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW)|Blood samples of participants who had fasted for 12-14 hours were collected for fasting proinsulin (precursor of insulin) and insulin assessment. Preproinsulin is sequentially processed via proinsulin, through intermediate proteolytic cleavage products, to insulin and C-peptide before release from the beta cell granule by exocytosis. Elevated levels of proinsulin are considered indicative of beta cell dysfunction. Insulin is a hormone that regulates carbohydrate and fat metabolism in the body. Change from Baseline was calculated as the value at Week 24/ EW minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||Picomoles per liter (pmol/L)||Standard Deviation|Mean
1380728|NCT01453049|Secondary|Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline|Blood samples of participants were collected for HbA1c assessment.|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1380729|NCT01453049|Secondary|Number of FPG Responders and Non-responders|Blood samples of participants were collected for FPG assessment. FPG responders are definded as participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG level < 6.1 mmol/L at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1380730|NCT01453049|Secondary|Number of HbA1c Responders and Non-responders|Blood samples of participants were collected for HbA1c assessment. HbA1c responders were defined as participants who had achieved HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1380866|NCT01451411|Secondary|Population Pharmacokinetics: Clearance (CL)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median CL|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.||||||
1385431|NCT01402128|Secondary|Changes in Visceral Adipose Tissue|Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||cm^3||Standard Deviation|Mean
1380731|NCT01453049|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood samples of participants were collected for FPG assessment. The FPG test, also known as the fasting blood sugar test, measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FBG was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|FAS. Missing values were imputed using the Last Observation Carried Forward (LOCF) method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1380732|NCT01453049|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|Full Analysis Set (FAS): all randomized participants who received >=1 dose of study medication and had >=1 post-Baseline efficacy assessment. Missing values were imputed using Last Observation Carried Forward (used to estimate subsequent missing data points). Only those participants contributing data at the indicated time points were analyzed.|||Percent of total hemoglobin||Standard Deviation|Mean
1380733|NCT01453036|Primary|Helicobacter Pylori Eradication Rate|Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.|8 weeks|Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence – 50%, expected dropout rate -15%, predicted eradication rate – 80%, significance level - 0.05, statistical power - 90%|||percentage of participants||95% Confidence Interval|Number
1380734|NCT01453023|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
1380735|NCT01453023|Secondary|Total Emitted Dose (TED) on Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
1380736|NCT01453023|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilopascal (kpa)||Standard Deviation|Mean
1380737|NCT01453023|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
1380867|NCT01451411|Secondary|Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline|an absolute serum sodium of 145 mEq/L at Hour 24 or an increase in serum sodium of greater than 12 mEq/L|baseline and Hours 3, 8, 12 and 24.||||participants|||Number
1385432|NCT01402128|Primary|Changes in Body Fat Mass(kg)|Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||kg||Standard Deviation|Mean
1380738|NCT01453023|Secondary|Inhalation Time on Days 1 and 14 of of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Seconds (sec)||Standard Deviation|Mean
1380739|NCT01453023|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
1380740|NCT01453023|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
1380741|NCT01453023|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters (cm)||Standard Deviation|Mean
1380742|NCT01453023|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day X)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters squared (cm^2)||Standard Deviation|Mean
1380743|NCT01453023|Secondary|Serum Cortisol (SC) Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period|"SC weighted mean was determined for each participant over the time period of 0–12 hours on Day 14 of the respective treatment period. SC weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 8, and 12 hours (relative to the 0 time point). Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect."|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||nanomoles per Liter||95% Confidence Interval|Geometric Mean
1380868|NCT01451411|Secondary|Change From Baseline in Free Water Clearance (FWC)||Baseline and 48 hours|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.||||||
1380744|NCT01453023|Secondary|Blood Glucose and Potassium Values on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1380745|NCT01453023|Secondary|Tmax and Tlast of VI on Day 1 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum VI concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.|||hours||Full Range|Median
1380746|NCT01453023|Secondary|Cmax of VI on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of VI on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1380747|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of VI on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for VI.|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
1380748|NCT01453023|Secondary|Tmax and Tlast of FF on Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
1380749|NCT01453023|Secondary|Cmax of FF on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of FF on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1380750|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of FF on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|FF Pharmacokinetic (PK) Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for FF.|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
1380751|NCT01453023|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|QTcF is the QT domain corrected for heart rate by Fridericia’s formula. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds||Standard Error|Least Squares Mean
1380762|NCT01453023|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1380752|NCT01453023|Primary|Change From Baseline in Heart Rate at Day1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Error|Least Squares Mean
1380753|NCT01453023|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1 and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1380754|NCT01453023|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||liters/minute||Standard Deviation|Mean
1380755|NCT01453023|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1380756|NCT01453023|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1380757|NCT01453023|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
1380758|NCT01453023|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1380759|NCT01453023|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
1380760|NCT01453023|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
1380761|NCT01453023|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||proportion of 1||Standard Deviation|Mean
1380785|NCT01452152|Secondary|Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization||One year||||participants|||Number
1380786|NCT01452152|Secondary|Occurrence of Adverse Events|The number of subjects reporting any AEs will be tabulated.|One year||||participants|||Number
1380763|NCT01453023|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1380764|NCT01453023|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1380765|NCT01453023|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 9)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
1380766|NCT01452854|Primary|Ovarian Aging (AFC and Hormones)|Transvaginal Ultrasound will be use to measure Antral Follicle Counts (AFC) and blood will be drawn to measure hormones (FSH, LH, estradiol, estrone, AMH, SHBG, testosterone, and inhibin B).|Every 3 months for 1 year|Data collection was terminated and analyses were not performed due to low enrollment||||||
1380767|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Baseline to Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||Participants|||Number
1380768|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Baseline to Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||Participants|||Number
1380769|NCT01452529|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding very much improved and much improved was summarized by treatment group."|Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||Participants|||Number
1380770|NCT01452529|Secondary|Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale|"The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales – sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - all of the time to 5 - none of the time. Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better sleep pattern."|Weeks 4, 8, and 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||Standard Deviation|Mean
1380771|NCT01452529|Primary|"Mean Pain Intensity for Average Pain Over the Last 24 Hours Score"|"Mean pain intensity for average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||Standard Error|Mean
1380772|NCT01452425|Primary|Intracompartmental Pressure (ICP)|[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block|45 minutes||||mmHg||Standard Deviation|Mean
1380773|NCT01452425|Primary|Comparison Between INVOS Monitoring and Electromyography|"A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block.~Measures were:~[mean (SD)] INVOS (in %) value at baseline and at the time of the block"|45 minutes||||% of StcO2||Standard Deviation|Mean
1380774|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12|Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group.|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
1380775|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
1380776|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
1380777|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
1380778|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1380779|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1380780|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1380781|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1380782|NCT01452269|Primary|Change in Physical Activity Assessment (PAA) Score|We measured the mean change in the moderate PAA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. PAA moderate activity scores range from 0-27; higher scores are better (more physical activity).|Baseline and 6 months||||moderate PAA score||Standard Error|Mean
1380783|NCT01452269|Primary|Change in Dietary Risk Assessment (DRA) Score|We measured the mean change in DRA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. DRA scores range from 0-96; lower scores are better (improved dietary quality).|Baseline and 6 months||||DRA score||Standard Error|Mean
1380784|NCT01452269|Primary|Weight Change|We measured the mean change in weight for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point.|Baseline and 6 months||||kilograms||Standard Error|Mean
1380788|NCT01452152|Secondary|Post-treatment Platelet Aggregation|Platelet aggregation will be performed on a subset of subjects using VerifyNow P2Y12 which measures platelet reactivity due to the effect of a P2Y12. Values less than 180 P2Y12 Reaction Units (PRU) suggest evidence of a P2Y12 inhibitor effect. Platelet aggregation studies are optional and will not be used to modulate antiplatelet therapy.|10 days|Optional platelet aggregation was performed in 3 of 5 participants randomized to the Genotype-directed, clopidogrel arm and 0 of 4 participants randomized to the Standard of Care arm.|||percentage of inhibition||Standard Deviation|Mean
1380789|NCT01452152|Secondary|Occurrence of Bleeding Events|Bleeding events will classified by the Bleeding Academic Research Consortium definition. The number of bleeding events will be tabulated.|One year||||events|||Number
1380790|NCT01452152|Primary|Occurrence of Post-randomization Cardiovascular Events|Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke, definite or probable stent thrombosis (ARC definition) and death secondary to any cardiovascular cause.|One year||||participants|||Number
1380791|NCT01452126|Secondary|Number of Patients With Complications|All patients were followed up for complications such as bleeding, infection, side effects, nerve damage|3 days||||Participants|||Count of Participants
1380792|NCT01452126|Primary|Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population|The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.|1 day||||percentage concentration, ropivacaine|||Number
1380793|NCT01451996|Secondary|Change in Wheal Reaction Area From Baseline --- 1 Hour|A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 1 hour post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm^2.|baseline and 1 hours post administration of Claritin||||Percent change||Standard Error|Mean
1380794|NCT01451996|Primary|Change in Wheal Reaction Area From Baseline --- 2 Hour|A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 2 hours post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm^2.|baseline and 2 hours post administration of Claritin.||||Percent change||Standard Error|Mean
1380795|NCT01451983|Primary|Total Brain Volume||Baseline|MRI acquisition was performed using Siemens Q4 TIM Trio 3 tesla scanner with standard 12-channel receive-only head coil. An 8-minute whole-brain T1-weighted inversion recovery turboflash (MPRAGE) was acquired. Volumetric measurements were obtained using the software suite Freesurfer. Not all participants received imaging due to age and impairment.|||cubic centimeters||Standard Deviation|Mean
1380796|NCT01451931|Secondary|Accuracy for Stones by Arm||Up to 6 month follow-up for stone passage||||Percent probability||95% Confidence Interval|Number
1380797|NCT01451931|Secondary|Return Visits to ED or Hospital||6 months post-baseline||||Number of visits|||Number
1380798|NCT01451931|Secondary|ED Length of Stay||Baseline visit excluding hospitalization||||Hours||Inter-Quartile Range|Median
1380799|NCT01451931|Primary|Cumulative Radiation Exposure||Baseline plus 6 months post-baseline||||mSv||Standard Deviation|Mean
1380800|NCT01451931|Primary|High Risk Diagnosis With Complication|Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.|30 days from baseline||||participants|||Number
1380801|NCT01451827|Secondary|Percent Change From Baseline in TKV at Week 8.|Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.|Baseline to Week 8|The core patient population for all efficacy analyses was based on the intent-to-treat (ITT) population which consisted of all randomized participants who take at least one dose of study drug. Observed Cases (OC) dataset within treatment period was defined as the data observed at study specified visits while subjects are taking study drug.|||Percentage change||Standard Deviation|Mean
1380802|NCT01451827|Secondary|Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)|The ADPKD-UIS was a self-administered questionnaire designed to measure ADPKD-related urinary symptoms in participants with ADPKD. This instrument contained 11 items in 3 domains (Urinary Frequency, Urinary Urgency, and Nocturia). Each item was scored using a scale of 1 to 5 (a higher score indicated increased difficulty/extremely bothered). The maximum total score is 55; 1: not difficult/not bothered at all; 55: extremely difficult/extremely bothered.|Baseline to Week 8|Participants who were randomized and had baseline and post-baseline observations in the total renal volume.|||Unit on a scale||Standard Deviation|Mean
1380803|NCT01451827|Primary|Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3|The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.|Baseline to Week 3|Participants who were randomized and had baseline and post-baseline observations in the total renal volume.|||Percentage change||Standard Deviation|Mean
1380804|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 26 Weeks|Biochemically verified abstinence from smoking over the past 7 days|26 Weeks||||percentage of participants abstinent|||Number
1380805|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 16 Weeks|Biochemically verified abstinence from smoking over the past 7 days|16 Weeks||||percentage of participants abstinent|||Number
1380806|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 8 Weeks|Biochemically verified abstinence from smoking over the past 7 days|8 weeks||||percentage of participants abstinent|||Number
1380869|NCT01451411|Secondary|Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours||Baseline, Hours 12, 24, 36 and 48|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.||||||
1380807|NCT01451775|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Screening until end of trial, average of 45 days|Treated Set(TS): TS includes all subjects who have taken at least 1 dose of trial medication|||participants|||Number
1380808|NCT01451775|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagloflozin (empa) in plasma, per period.~The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1380809|NCT01451775|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞).~The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1380810|NCT01451762|Primary|Quality of Recovery 40 at 24 Hours|Scores on QOR (quality of recovery) 40 questionnaire.The QoR-40 score, which ranges from 40 to 200, representing very poor to outstanding quality of recovery, respectively.|24 hours post operatively|Primary outcome was QOR 40 a sample size of 23 per group was estimated to achieve 80% power to detect a 10 point difference in aggregated QOR040 score for the three groups. A 10 point difference represents a clinically relevant improvement in quality of recovery. TO account for drop outs lost to follow up 90 subjects were randomized.|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
1380811|NCT01451749|Secondary|Change in Functional Scores: Instrumental Activities of Daily Living (IADL).|Functional ability was evaluated with the Instrumental Activities of Daily Living (IADL) IADL, at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The IADL contains eight items, which are the ability to use a telephone, shop, prepare food, run laundry, use modes of transportation, take responsibility for one’s own medications, complete housekeeping, and handle finances,each items ranges from 1 to 4 points, 1 points means no problem, and 4 points means greater impairment in instumental acvtiveity of daily living.The total is sub of the eight items, and the total range of the IADL is 8-32 points, higher scores indicate greater impairments. The changes was calculted by weeks 24 minus baseline.|Baseline to weeks 24|The efficacy measurement were conducted in the intent-to-treat population, the ITT consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.|||units on a scale||95% Confidence Interval|Mean
1380812|NCT01451749|Secondary|Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB)|memory function was evaluated with the DSR subtest,at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The DSR is a tool which was designed to assess immediate registration of verbal information and retention over time. It contains six sub-tests: two verbal memory tests (one of which is a story recall), two visual memory tests and two information-processing tests. The story recall test includes immediate story recall (ISR) and delayed story recall (DSR). The DSR total score ranges from 0-56 points. Lowers score means higher impairment of memory.The Change in cognitive scores was calculated as 24 week minus the baseline.|Baseline and 24 weeks|The efficacy measurement was conducted of ITT patients. The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.|||units on a scale||95% Confidence Interval|Mean
1380813|NCT01451749|Primary|Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)|Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) , at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24. The ADAS-cog was designed specifically to evaluate the severity of cognitive dysfunctions characteristic of AD patients and includes 11 items. Among these items, memory, orientation, language function, practical ability, and attention are evaluated. The score on the ADAS-cog range from 0 to 70 point, with 0 point indicating no impairment and 70 points indicating severe impairment of cognition. In the Shenwu capsule group, the ADAS-cog score is ranges 3-38.3 points, and 3.3-30.7 points in the Donepezil group. The Change in cognitive scores was calculated as24 week minus the baseline.|baseline and 24 weeks|the analyses for efficacy were conducted in the intent-to-treat population (ITT). The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.|||units on a scale||95% Confidence Interval|Mean
1380814|NCT01451723|Secondary|Brain Atrophy|Difference between the two groups in brain atrophy as measured by SIENA|1 year|||||||
1380815|NCT01451723|Primary|Rate of Change in NAA Levels Adjusted for Water Content.|The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.|1 year|No subjects completed either the six or twelve month point so no data was available for analysis.||||||
1380816|NCT01451645|Secondary|Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||days||Standard Deviation|Mean
1380821|NCT01451632|Secondary|Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121|Data presented by dose level of MM-121, regardless of the cohort (i.e. 15 patients in Part 1 were administered the 40/20 dose level of MM-121: 3 in cohort 3b, 4 in cohort 4, and 8 in the Part 1 expansion)|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
1380822|NCT01451632|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121||||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1380823|NCT01451632|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks||||participants with objective response|||Number
1380824|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD~Part 1:~Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW~Part 2:~Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs and thus not included in determining MTD/RP2D) NOTE: MTD of MM-121 provided in separate endpoint entry|||mg/m2|||Number
1380825|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD~Part 1:~Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW~Part 2:~Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs) MTD of cetuximab and irinotecan for the combination(s) are presented in a separate endpoint entry|||mg/kg|||Number
1380826|NCT01451632|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination|To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 48.1 weeks|Patients participating in dose escalation|||participants reporting DLTs|||Number
1380827|NCT01451606|Secondary|Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain|This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1380828|NCT01451606|Primary|Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).|The primary clinical efficacy measure is the change in spontaneous (non-evoked) pelvic pain from the baseline period to the end of treatment. This was assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. Larger values (greater changes in ratings) are better outcomes.|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
1380829|NCT01451554|Primary|Weight Change at 6 Months|Weight change as a percentage of baseline at post 6 months.|6 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.|||percentage||Standard Deviation|Mean
1380835|NCT01451541|Secondary|Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.|||Number of Days|||Number
1380836|NCT01451541|Secondary|Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.|||units on a scale||Standard Error|Least Squares Mean
1380837|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1380838|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.|||units on a scale||Standard Error|Least Squares Mean
1380839|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1380840|NCT01451541|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1380841|NCT01451541|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1380870|NCT01451411|Secondary|Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L)||baseline and 48 hours||||participants|||Number
1380871|NCT01451411|Secondary|Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||baseline and 48 hours||||participants|||Number
1380872|NCT01451411|Secondary|Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||48 hours|Data from two subjects (one conivaptan, and one placebo) were censored as the serum sodium never achieved a value greater or equal to 4 mEq/L above the baseline value.|||hours||Full Range|Mean
1380842|NCT01451541|Primary|The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0-6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1380843|NCT01451463|Other Pre-specified|Six Condition Romberg Test|The Six Condition Romberg Test is used assess static balance. Subjects are tested standing with their arms crossed over their chests and are assessed for 30 seconds in the following 6 conditions: 1) feet together, 2) feet together eyes closed, 3) feet aligned in tandem heel-to-toe position eyes open, 4) feet aligned in tandem heel-to-toe position eyes closed, 5) standing in tandem position while counting backwards by 3's from 100 with eyes open, 6) standing in tandem position while counting backwards by 3's from 100 with eyes closed. Comparison of performances were made when off stable dose of tetrabenazine for > 18 hours to performance 2 hours after resumption of tetrabenazine. If a participant could not hold a stance for the full 30 seconds, then that component of the Romberg test ended at that point with the time of that component scored in seconds; 30 seconds being the maximum score for each of the 6 tests. The total score was calculated as a sum of all of the 6 subset scores.|>18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine||||Six Condition Romberg Test score||Standard Deviation|Mean
1380844|NCT01451463|Secondary|Five Times Sit to Stand Test|Subjects are asked to sit in a chair with their arms across their chests and asked to stand and sit five times in a row. The time it takes to complete 5 sit to stand cycles is timed with a stop watch. Comparison is made when off stable dose of tetrabenazine for >18 hours to performance 2 hours after resumption of tetrabenazine. Lower time scores are associated with better balance.|>18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine||||seconds to complete 5 sit to stand cycle||Standard Deviation|Mean
1380845|NCT01451463|Primary|Tinetti Mobility Test Score|The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for >18 hours with the performance two hours after resuming tetrabenazine was made.|>18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine||||Total Tinetti Mobility Test Score (TMT)||Standard Deviation|Mean
1380846|NCT01451437|Secondary|Urine Concentration of MK-8242 (Part 2 Arm A Only)|The urine concentration of MK-8242 assessed as a measure of drug bioavailability was not determined due to early termination of the study (Study Part 2 was not performed).|Day 1 (predose and postdose) and Day 7 (postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (urine concentration) at the time of assessment||||||
1380847|NCT01451437|Secondary|Accumulation Ratio (R) of MK-8242 Alone and in Combination With Cytarabine|The accumulation ratio (R) at steady state (based on dosing interval and apparent terminal half-life (t1/2)) for MK-8242 alone was not determined due to confounding of results by significant concentrations of a drug metabolite (M16). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (R) at the time of assessment.||||||
1380848|NCT01451437|Secondary|Apparent Terminal Half-life (t1/2) for MK-8242 Alone and in Combination With Cytarabine|Elimination phase t1/2 was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (at least three time-points after Tmax).|||hr||Geometric Coefficient of Variation|Geometric Mean
1380849|NCT01451437|Secondary|Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine|Tmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Tmax) at the time of assessment.|||Hours||Full Range|Median
1380850|NCT01451437|Secondary|Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine|Cmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Cmax) at the time of assessment.|||nM||Geometric Coefficient of Variation|Geometric Mean
1380873|NCT01451411|Primary|Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium||baseline and 48 hours||||mEq/L||Standard Deviation|Mean
1380874|NCT01451398|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24|||kg||Standard Error|Least Squares Mean
1380851|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for MK-8242 Alone and in Combination With Cytarabine|AUC0-∞ defined as AUC from time zero to infinity was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax (condition not met for 60 QD and 120 BID dose groups). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-∞) at the time of assessment.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
1380852|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-last) defined as AUC from time zero to the time of last quantifiable sample was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-last) at the time of assessment.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
1380853|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-24hr) defined as AUC from time zero to 24 hours was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. For the BID arms, a projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 24 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], and 24 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-24hr) at the time of assessment.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
1380854|NCT01451437|Secondary|Number of Participants With CRi at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at dose levels other than RP2D. CRi is defined as fulfillment of all CR criteria with exceptions for residual neutropenia (<1,000/µL), thrombocytopenia (<100,000/µL), and RBC transfusion dependence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.|||Participants|||Number
1380855|NCT01451437|Secondary|Number of Participants With CR at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at dose levels other than RP2D. CR is defined as a morphologic leukemia-free state with a neutrophil count ≥1,000/µL, a platelet count ≥100,000/µL, no extramedullary disease, and RBC transfusion independence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.|||Participants|||Number
1380856|NCT01451437|Primary|Number of Participants With Complete Remission With Incomplete Marrow Recovery (CRi) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.||||||
1380857|NCT01451437|Primary|Number of Participants With Complete Remission (CR) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 wild type (WT) status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.||||||
1380858|NCT01451437|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with <5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) <100/µL, platelet count <10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.|Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities|DLT-evaluable Population: participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 or discontinued due to reason of toxicity.|||Participants|||Number
1380859|NCT01451424|Secondary|Change in Quality of Life|Percentage change from baseline in median quality of life using uterine fibroid symptom and quality of life questionnaire (UFSQOL)|12 or 16 weeks|MITT. Note: lower score is improvement|||Percent change||Full Range|Median
1380884|NCT01451398|Secondary|FPG Change From Baseline to Week 24|Efficacy as measured by mean change in fasting plasma glucose (FPG)|Baseline to Week 24|Full analysis set for subjects with data at both Baseline and at Week 24|||mg/dL||Standard Error|Least Squares Mean
1380885|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 6.5%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24|Week 24|Full analysis set for subjects with available data at Week 24|||percentage of participants|||Number
1380886|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set for subjects with available data at Week 24|||percentage of participants|||Number
1380887|NCT01451398|Primary|Change From Baseline to Week 24 in HbA1c|Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24|Baseline to Week 24|Full analysis set|||percentage of hemoglobin||Standard Error|Least Squares Mean
1380888|NCT01451203|Secondary|Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR Boolean-based remission rate measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~Patient's global assessment of disease activity (PtGADA);~C-reactive protein (CRP)~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~A participant was considered to be in remission if all the criteria for each variable was met:TJC (in 28 joints) ≤1; SJC (in 28 joints) ≤1; CRP ≤1 mg/dl; PtGADA ≤1.~Last Observation Carried Forward (LOCF) was applied"|Week 24 and Week 52|FAS|||percentage of participants||95% Confidence Interval|Number
1380889|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Simplified Disease Activity Index (SDAI)-Based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR SDAI remission rate measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~Patient's global assessment of disease activity (PtGADA);~Physician’s Global Assessment of Disease Activity (PhGADA);~C-reactive protein (CRP)~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~A participant was considered to be in remission if SDAI ≤3.3.~Last Observation Carried Forward (LOCF) was applied."|Week 24 and Week 52|FAS|||percentage of participants||95% Confidence Interval|Number
1380890|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52|"The DAS28(ESR) measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~ESR;~Patient's global assessment of disease activity (PtGADA).~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A participant was considered to be in remission if DAS28(ESR) <2.6.~Last Observation Carried Forward” (LOCF) was applied."|Week 24 and Week 52|FAS|||percentage of participants||95% Confidence Interval|Number
1380891|NCT01451203|Secondary|Change From Baseline in mTSS at Week 24|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 24|FAS with available data.|||units on a scale||Standard Deviation|Mean
1380892|NCT01451203|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 52|FAS with available data.|||units on a scale||Standard Deviation|Mean
1380893|NCT01450826|Secondary|Time to Treatment Failure|Median time in days to first emetic episode or first need of rescue medication, whichever occurred first as measured by the MAT/Osoba survey, among those patients experiencing an emetic episode or need of rescue medication|7 days|This analysis only includes those patients no achieving complete control (no emetic episode or need for rescue medication throughout the 7-day study period).|||days||Full Range|Median
1380910|NCT01450787|Other Pre-specified|Schirmer Score|The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.|at the time of the exam|Each patient underwent schirmer testing|||mm|Participants|Standard Error|Mean
1380911|NCT01450787|Other Pre-specified|OSDI Score|The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.|at the time of the exam|All patients completed the OSDI survey|||units on a scale||Standard Error|Mean
1380894|NCT01450826|Secondary|Patient's Global Satisfaction With the Antiemetic Regimen|Patients’ global satisfaction with the antiemetic regimen is measured using the Osoba survey, which was administered on days 1-7. This survey asks patients “In the past 24 hours, did vomiting or dry heaves a) interfere with your appetite, b) affect your sleep, c) interfere with your physical activities, d) interfere with your social life, and e) interfere with your enjoyment of life?” Patients responded on a scale of 1-4 ranging from ‘Not at all’ to ‘Very much.’ Global satisfaction was defined as responding ‘Not at all’ for all questions related to vomiting/retching for each study day. The proportion of patients responding ‘Not at all’ for all Osoba vomiting/retching questions over the study period is reported.|7 days|2 patients in the Aprepitant + Ondansetron arm and 4 patients in the Ondansetron arm did not have adequate survey data for this analysis|||proportion of patients|||Number
1380895|NCT01450826|Secondary|Proportion of Patients Achieving an Acute and Delayed Complete Response (CR)|CR is the proportion of patients with no emetic episode and no rescue medication. (1) Assessed from the beginning of study day 1, CR is defined for acute CINV as no emetic episode and no use of rescue anti-nausea medication during the first 24 hours following chemotherapy administration. An emetic episode is defined as one episode of vomiting or a sequence of episodes in very close succession not relieved by a period of relaxation of at least 1 min, any number of unproductive emetic episodes (retches) in any given 5 minute period, or an episode of retching lasting <5 minutes combined with vomiting not relieved by a period of relaxation of at least 1 minute; (2) Complete response (CR) on study days 2–7 (delayed CINV) is defined as the proportion of patients achieving a CR during the delayed time period. The data will be captured by the validated ultinational Association of Supportive Care in Cancer (MASCC) Anti-emesis Tool (MAT)/Osoba survey.|7 days|Intent to treat|||proportion of patients|||Number
1380896|NCT01450826|Primary|Proportion of Patients Achieving Complete Control (CC)|Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4.0).|7 days|Intent to treat|||proportion of patients|||Number
1380897|NCT01450813|Secondary|The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups|Mean CVI from incision to propofol off reported as the mean CVI +/- 95% confidence interval for the two groups|Maintenance Anesthesia||||units on a scale||95% Confidence Interval|Mean
1380898|NCT01450813|Primary|The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups|"The difference between the mean CVI in three minutes prior to laryngoscopy and three minutes following laryngoscopy reported as the mean change in CVI and the +/- 95% confidence interval for each group.~The Composite Variability Index (CVI) scale is a logistic regression of three measures of processed electroencephalography (EEG) signals. These signals are Bispectral Index (BIS), the variability of electromyelogram (sEMG), and the variability of BIS (sBIS). The scale ranges from 0 to 100 where a lower CVI value represents a lower likelihood of intraoperative somatic responses, and a higher CVI value represents a higher likelihood of intraoperative somatic responses."|Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention||||units on a scale||95% Confidence Interval|Mean
1380899|NCT01450800|Other Pre-specified|Antibiotic Resistance to Macrobid|We examined for macrobid resistance on urine culture results within 3 weeks of surgery|6 weeks after surgery|Examined urine cultures with susceptibility testing results for all participants who had positive urine culture results|||urine culture resistant to nitrofurantoi|||Number
1380900|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to postoperative catheter type|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
1380901|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to total postoperative catheter days|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||days of catheterization||95% Confidence Interval|Median
1380902|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to sling as part of surgery|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
1380903|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to Creatinine Clearance|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||mL/min||Standard Deviation|Mean
1380904|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to preoperative UTI treatment|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
1380905|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to history of recurrent UTIs|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
1380906|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to vaginal estrogen therapy|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
1380907|NCT01450800|Primary|Urinary Tract Infections|The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.|three weeks post-operative|Intent-to-treat analysis|||participants|||Number
1380908|NCT01450787|Other Pre-specified|Corneal Staining|Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.|at the time of the exam|All patients underwent corneal staining evaluations using fluorescein.|||units on a scale|Participants|Standard Error|Mean
1380909|NCT01450787|Other Pre-specified|Tear Break-up Time|The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.|at the time of the exam|Each patient underwent tear break-up time testing|||seconds|Participants|Standard Error|Mean
1380912|NCT01450787|Secondary|Tear Film Osmolarity|The tear film osmolarity is measured at the time of the exam.|at the time of the exam|Tear film osmolarity was measured in all patients, but two patients in the diabetic group had an insufficient tear film to obtain a reading. Therefore, only 36 diabetics were included.|||mOsml/L|Participants|Standard Error|Mean
1380913|NCT01450787|Primary|Conjunctival Staining Score|Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.|at the time of the evaluation|There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.|||units on a scale|Participants|Standard Error|Mean
1380914|NCT01450761|Secondary|Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy|Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|From randomization until disease progression, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy|||months||95% Confidence Interval|Median
1380915|NCT01450761|Secondary|Overall Survival in All Randomized Participants|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization until date of death, up to March 2015, approximately 38 months|All randomized participants|||months||95% Confidence Interval|Median
1380916|NCT01450761|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|Randomization until date of death, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy|||months||95% Confidence Interval|Median
1380917|NCT01450696|Secondary|Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS|Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days)|"FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, n reflects the number of participants who were evaluable for each category in the respective arms."|||μg/mL||Standard Deviation|Mean
1380918|NCT01450696|Secondary|Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS|Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL.|Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, “n” reflects the number of participants who were evaluable for each category in the respective arms.|||μg/mL||Standard Deviation|Mean
1380919|NCT01450696|Secondary|Percentage of Participants With Objective Response - PPS|Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||percentage of participants||95% Confidence Interval|Number
1380920|NCT01450696|Secondary|Progression-Free Survival - PPS|Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||months||95% Confidence Interval|Median
1380921|NCT01450696|Secondary|Percentage of Participants With Disease Progression or Death - PPS|Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||percentage of participants|||Number
1380922|NCT01450696|Secondary|Overall Survival - PPS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||months||95% Confidence Interval|Median
1380923|NCT01450696|Secondary|Percentage of Participants Who Died - Per Protocol Set (PPS)|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|The PPS included all participants who were found to have a trastuzumab minimum plasma concentration (Cmin) less than (<) 12 micrograms per milliliter (μg/mL) on treatment Day 21 of Cycle 1 following the initial loading dose of 8 mg/kg.|||percentage of participants|||Number
1380924|NCT01450696|Primary|Overall Survival - FAS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1380925|NCT01450696|Primary|Percentage of Participants Who Died - FAS|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1380926|NCT01450683|Primary|Reduction in Serum PSA|Number of subjects with > 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks|12 weeks treatment, with primary outcome assessed at 15 weeks||||participants|||Number
1380927|NCT01450631|Secondary|Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:~Antimicrobials for surgical site infection~Surgical drainage of the incision~Surgical incision packing~Adjunctive negative pressure therapy~Debridement~Re-operation"|Post-op Day: 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.|||participants|||Number
1380928|NCT01450631|Primary|Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:~Unanticipated local inflammatory response~Prolonged drainage~Fluid collection~Dehiscence~Surgical site infection (SSI)"|Post-op Day 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.|||participants|||Number
1380929|NCT01450397|Primary|The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.|Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.|Baseline and 30 days||||mm^3||Full Range|Mean
1380930|NCT01450319|Secondary|Beta 2-microglobulin||Baseline, Week 8|"MITT analysis set included all the subjects who received study drug treatment. Here n signifies number of evaluable subjects for each category, as specified."|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1380931|NCT01450319|Secondary|Overall Survival (OS) Related to Killer Inhibitory Receptors 2DS4 (KIR2DS4) Functional Receptor (f/d) and Non-functional Receptor (NFR)|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal assessed up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies number of evaluable subjects for this outcome measure."|||months||95% Confidence Interval|Median
1380932|NCT01450319|Secondary|Overall Survival (OS) Related to Codon G13D|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies total number of evaluable subjects for this outcome measure; “n” signifies number of evaluable subjects for each category, as specified."|||months||95% Confidence Interval|Median
1380933|NCT01450319|Secondary|Number of Subjects With Fcγ Receptors (FCγR) IIa/IIIa Polymorphisms|The antibody fragment C portion (FCy) of cetuximab interacts with Fc-gamma receptors (FCyRs) expressed by immune effector cells. Polymorphisms were described in genes coding for FCyRIIa and in FCyRIIIa. A histidine/arginine polymorphism at position 131 for FCyRIIa gene and valine ⁄ phenylalanine polymorphism at position 158 for the FCyRIIIa gene were reported to be functionally relevant in the ADCC mechanism. All subjects were analyzed and classified as carriers of every different polymorphism of FCy Receptors: for FCyRIIa (H/H, homozygous alleles with histidine and R/H, heterozygous alleles with arginine/histidine) and FCyRIIIa (V/V, homozygous alleles with valine, F/F, homozygous alleles with phenylalanine and F/V, heterozygous alleles with valine ⁄ phenylalanine) (units: subjects with every type of polymorphism) .The FCyR genotype was determined using a TaqMan Allelic Discrimination Assay.|Baseline|MITT analysis set included all the subjects who received study drug treatment. Subjects may fall into more than one category.|||Subjects|||Number
1380934|NCT01450319|Secondary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, AEs Leading to Death|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the date of enrollment up to 30 days after the last dose of study drug administration, assessed up to 3 years|Safety analysis set included all the subjects who received at least one dose of the study drug treatment.|||Subjects|||Number
1381114|NCT01449279|Secondary|Overall Survival|Median time to overall survival was calculated using the Kaplan-Meier algorithm.|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|All subjects|||weeks||Full Range|Median
1380935|NCT01450319|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the time from informed consent signature until PD or death, whatever occurred first. Subjects who did not have disease progression or were lost to follow-up, were censored at the date of last contact, known to be alive and progression free; moreover, those subjects who started a new treatment (different from cetuximab), were censored at the date of starting the new treatment. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|From the date of informed consent signature until progressive disease (PD) or death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.|||Months||95% Confidence Interval|Median
1380936|NCT01450319|Secondary|Percentage of Subjects With Disease Control Rate (DCR)|DCR was defined as those subjects achieving complete response (CR), partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of longest diameter (SLD) of the TLs, taking as a reference the baseline (BL) SLD; Stable disease (SD) was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and progressive disease (PD) was defined as the appearance|From the date of informed consent signature until progressive disease, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.|||Percentage of subjects|||Number
1380937|NCT01450319|Primary|Overall Survival (OS) Time|Overall survival was defined as the time from date of informed consent signature until death.|From the date of informed consent signature until death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.|||Months||95% Confidence Interval|Median
1380938|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Improvement|"Clinician rating of global illness severity (at post-treatment)~CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2"|2 weeks||||participants|||Number
1380939|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Severity|"Clinician rating of global illness severity (at pre- and post-treatment)~CGI-Severity range 1-7; higher scores indicate greater illness severity."|2 weeks||||units on a scale||Standard Deviation|Mean
1380940|NCT01450306|Primary|Snake Questionnaire (SNAQ)|"30-item self-report scale of severity of snake fear and avoidance~Range: 0-30; higher values indicate greater fear severity"|2 weeks||||units on a scale||Standard Deviation|Mean
1380941|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Men|median HIV RNA concentration as measured in semen|52 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
1380942|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Men|median HIV RNA concentration as measured in semen|26 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
1380943|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Men|median HIV RNA concentration as measured in semen|12 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
1380944|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Women|median HIV RNA concentration in cervical lavage fluid|52 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
1380945|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Women|median HIV RNA concentration in cervical lavage fluid|26 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
1380946|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Women|median HIV RNA concentration in cervical lavage fluid|12 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
1380947|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 52||52 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.|||copies/ml||Full Range|Median
1380948|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 26||26 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.|||copies/ml||Full Range|Median
1380949|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 12||12 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.|||copies/ml||Full Range|Median
1380950|NCT01450189|Secondary|Time to HIV RNA Suppression <1000 c/ml|median time to viral load suppression (<1000 c/ml)|From date of randomization until viral load suppression, up to 52 weeks||||weeks||95% Confidence Interval|Median
1380951|NCT01450189|Secondary|Suppression of HIV RNA to <1000c/ml at 12 Weeks|Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks|12 weeks||||Proportion of participants||95% Confidence Interval|Number
1380952|NCT01450189|Secondary|Proportion of Partners Reporting for HIV Testing|Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants|52 weeks|The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35)|||proportion of sex partners|sexual partners|95% Confidence Interval|Number
1380953|NCT01450189|Secondary|Number of Partners Reporting for HIV Testing|Number of partners per index reporting for HIV testing at any time during follow-up|52 weeks||||partners per index participant||95% Confidence Interval|Mean
1381047|NCT01449526|Primary|Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.|4 visits over 3 months|All Eligible, Dispensed Eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
1380954|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.|52 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52|||Proportion of participants||95% Confidence Interval|Number
1380955|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.|26 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26|||Proportion of participants||95% Confidence Interval|Number
1380956|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|At least one incident infection with either gonorrhea, chlamydia or trichomoniasis|52 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26|||proportion of participants||95% Confidence Interval|Number
1380957|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis|26 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests|||proportion of participants||95% Confidence Interval|Number
1380958|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 52 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/month||95% Confidence Interval|Mean
1380959|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 26 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/month||95% Confidence Interval|Mean
1380960|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 12 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/month||95% Confidence Interval|Mean
1380961|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 52 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/week||95% Confidence Interval|Mean
1380962|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 26 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/week||95% Confidence Interval|Mean
1380963|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 12 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/week||95% Confidence Interval|Mean
1380964|NCT01450189|Primary|Number of Adverse Events|Mean number of adverse events per group|one year||||number of events||95% Confidence Interval|Mean
1380965|NCT01450189|Primary|Proportion of Persons Completing All Scheduled Visits in Each Study Arm||1 year||||Proportion of participants||95% Confidence Interval|Number
1380966|NCT01450189|Primary|Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.|In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.|1 year|All persons in the two behavioral intervention arms|||proportion of participants||95% Confidence Interval|Number
1380967|NCT01450189|Primary|Proportion of Participants Completing Full Course of ARVs in Arm BIA|Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that|1 year|Number of persons in BIA arm eligible for study-provided ARVs|||proportion of BIA participants||95% Confidence Interval|Number
1380968|NCT01450189|Primary|Proportion of Persons With AHI Successfully Recruited Into the Study|This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.|1 year||||Proportion of persons with AHI recruited||95% Confidence Interval|Number
1380969|NCT01450189|Primary|Prevalence of AHI Among Persons Screened|Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.|1 year||||proportion of participants||95% Confidence Interval|Number
1380970|NCT01450189|Primary|Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening||1 year|All persons screened|||proportion of participants screened||95% Confidence Interval|Number
1380971|NCT01450007|Secondary|Patient Satisfaction With Pain Control|Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.|24 hours, 48 hours, 1 week|Patients analyzed for each category varied see explanations per row (time point): (n=dexamethasone block, dexamethasone IV, placebo).|||units on a scale||Standard Deviation|Mean
1380972|NCT01450007|Secondary|Time Until First Dose of Analgesic||Approximately 10 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.|||hours||Standard Deviation|Mean
1380973|NCT01450007|Secondary|Post Operative Opioid Dose at 24 Hours||approximately 24 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.|||mg morphine equivalents||Standard Deviation|Mean
1380974|NCT01450007|Primary|Duration of Sensory Blockade|Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.|Within 48 hours|Patients will be included in the primary analysis on the basis of intention to treat.|||hours||Standard Deviation|Mean
1385433|NCT01402115|Secondary|Changes in PTH(Parathyroid Hormone)|PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||pg/mL||Standard Deviation|Mean
1380975|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS is a 16-item self-report measure that assesses how much a participant endorses each of the DSM-IV-TR symptoms of depression, with each item scored from 0 (no endorsement of symptom) to 3 (endorsement of severe symptomatology). Scores on the QIDS range from 0-27, with higher scores indicating higher depressive symptom severity.|change in QIDS score from baseline to 3 months posttreatment||||units on a scale||Standard Deviation|Mean
1380976|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS is a 16-item self-report measure that assesses how much a participant endorses each of the DSM-IV-TR symptoms of depression, with each item scored from 0 (no endorsement of symptom) to 3 (endorsement of severe symptomatology). Scores on the QIDS range from 0-27, with higher scores indicating higher depressive symptom severity.|change in QIDS score from baseline to 1 month posttreatment||||units on a scale||Standard Deviation|Mean
1380977|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report instrument which assesses the intensity of Posttraumatic Stress Disorder symptoms. The PCL measures the 17 DSM-IV PTSD criteria in 17 items. For each item the participant can respond with a rating of 1-5 (with 1 indicating not at all bothered 5 indicating extremely bothered by the symptom) The range of total scores on the PCL is from 17-85, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items.|change in PCL score from baseline to 3 months posttreatment||||units on a scale||Standard Deviation|Mean
1380978|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report instrument which assesses the intensity of Posttraumatic Stress Disorder symptoms. The PCL measures the 17 DSM-IV PTSD criteria in 17 items. For each item the participant can respond with a rating of 1-5 (with 1 indicating not at all bothered 5 indicating extremely bothered by the symptom) The range of total scores on the PCL is from 17-85, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items.|change in PCL score from baseline to 1 month posttreatment||||units on a scale||Standard Deviation|Mean
1380979|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|The CAPS is administered to assess the frequency and intensity of PTSD symptoms at baseline, and then again 3 months posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.|change in CAPS score from baseline to 3 months posttreatment||||units on a scale||Standard Deviation|Mean
1380980|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|Clinician administered interview which assesses the symptoms of Posttraumatic Stress disorder at baseline, and then again 1 month posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.|Baseline and 1 month posttreatment||||scores on a scale||Standard Deviation|Mean
1380981|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Convenience Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The convenience score is the score for item 5 (range: 0-6). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population.|||Scores on a scale||Standard Deviation|Mean
1380982|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Lifestyle/Ease Sub Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The lifestyle/ease score is the sum of items 4, 5, 6, 7 and 8 (range: 0-30). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population.|||Scores on a scale||Standard Deviation|Mean
1380991|NCT01449929|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shift to CDC Class C, or New CDC Class C or Death at Week 48|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|Week 48|mITT-E Population|||Participants|||Number
1380983|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Total Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The treatment satisfaction score (range: 0-60) was the sum of the individual items. HIVTSQ mITT-E Population=Only participants from USA, France, Germany, Italy, Spain for whom valid translations were available from the mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population.|||Scores on a scale||Standard Deviation|Mean
1380984|NCT01449929|Secondary|Change From Baseline in EQ-5D Thermometer Scores at Week 24 and Week 48|The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. Thermometer score is based on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, Baseline viral load, background dual NRTI therapy and Baseline EQ-5D thermometer score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24, and Week 48|mITT-E Population.|||Scores on a scale||Standard Error|Mean
1380985|NCT01449929|Secondary|Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Utility Scores at Week 24 and Week 48|The EQ-5D is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and Baseline EQ-5D utility score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24, and Week 48|mITT-E Population.|||Scores on a scale||Standard Error|Mean
1380986|NCT01449929|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Bother Score at Week 4, Week 24, and Week 48|SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and baseline symptom bother score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicates a decline in a participant’s quality of life over that period.|Baseline, Week 4, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.|||Scores on a scale||Standard Error|Mean
1380987|NCT01449929|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Resistance to DTG, DRV+RTV and Other On-study ART at Time of Protocol Defined Virology Failure (PDVF)|An assessment was made of every change across all amino acids within the integrase (IN), reverse transcriptase (RT), and Protease (PRO) encoding region at Baseline and at time of suspected PDVF. PDVF is defined as the confirmed plasma HIV-1 RNA >200 c/mL >=Week 24. PDVF Genotypic Population included all participants in the mITT-E population with available on-treatment genotypic resistance data, at time of PDVF. Only those participants with data available at the specified time points were analyzed.|Baseline until PDVF up to Week 48|PDVF Genotypic Population|||Participants|||Number
1380988|NCT01449929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Maximum Post-Baseline Chemistry and Hematology Laboratory Toxicities|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred.|From Baseline through Week 48|mSafety Population|||Participants|||Number
1380989|NCT01449929|Secondary|Percentage of Participants With Grade 2 or Higher Abnormalities in Fasting LDL Cholesterol Through Week 48|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for which an increase in fasting LDL cholesterol to Grade 2 or higher occurred. Only those participants with data available at the specified time points were analyzed.|From Baseline through Week 48|mSafety Population.|||Percentage of Participants|||Number
1380990|NCT01449929|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol Through Week 48|Fasting LDL cholesterol change from Baseline was analyzed. Values represented are for adjusted means. Estimates are calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, background dual NRTI therapy, Baseline LDL cholesterol, treatment*visit interaction and Baseline LDL cholesterol*visit interaction. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed.|From Baseline through Week 48|mSafety Population.|||Millimoles per liter (mmol/L)||Standard Error|Mean
1380992|NCT01449929|Secondary|Change From Baseline in CD4+ and CD8+ Cell Counts|Change from Baseline in CD4+ cell counts was assessed at Weeks 4, 8, 12, 16, 36 and 48. Change from Baseline in CD8+ cell counts was assessed at Weeks 4, 12, 24 and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits and parameters, so the overall number of participants analyzed reflects everyone in the mITT-E Population.|Baseline and Weeks 4, 8, 12, 16, 36 and 48 for CD4+ and Baseline and Weeks 4, 12, 24 and 48 for CD8+|mITT-E Population.|||Cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
1380993|NCT01449929|Secondary|Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48|Change from Baseline in plasma HIV-1 RNA (log10 c/mL) was assessed at Weeks 4, 8, 12, 16, 24, 36 and 48 . Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.|Baseline, Weeks 4, 8, 12, 16, 24, 36 and 48|mITT-E Population.|||Log10 copies per mL||Standard Deviation|Mean
1380994|NCT01449929|Secondary|Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Week 48|"The percentage of participants with Plasma HIV-1 RNA <400 c/mL at Week 48 was assessed MSDF, as codified by the FDA snapshot algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks)."|Week 48|mITT-E Population|||Percentage of participants|||Number
1380995|NCT01449929|Secondary|Time to Virologic Suppression (<50 Copies/mL) Through Week 48|The time to viral suppression (i.e. first viral load value <50 copies/mL) through Week 48 was derived and summarized using Kaplan-Meier plots. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. Confidence intervals were estimated using the Brookmeyer-Crowley method.|From Baseline through Week 48|mITT-E Population|||Days||95% Confidence Interval|Median
1380996|NCT01449929|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48|"Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks). Modified Intent-To-Treat Exposed (mITT-E) Population:all randomized participants who received at least one dose of investigational product"|Week 48|mITT-E Population|||Percentage of participants|||Number
1380997|NCT01449812|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
1380998|NCT01449812|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
1380999|NCT01449812|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
1381000|NCT01449812|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
1381001|NCT01449812|Primary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN|Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381002|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1381003|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1381004|NCT01449812|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381005|NCT01449812|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381006|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1381007|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1381008|NCT01449812|Primary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381009|NCT01449812|Primary|Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381010|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1381011|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1381012|NCT01449812|Primary|Number of Seroprotected Subjects Against PRP|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381013|NCT01449812|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381046|NCT01449526|Secondary|Slit Lamp > Grade 2|Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.|3 months|Number of dispensed eyes with non-missing scores in each treatment group.|||eyes (2 per participant)|Participants||Number
1381014|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1381015|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1381016|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381017|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1381018|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1381019|NCT01449812|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
1381020|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Titers||95% Confidence Interval|Geometric Mean
1381021|NCT01449812|Primary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
1381022|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||µg/mL||95% Confidence Interval|Geometric Mean
1381023|NCT01449812|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
1381024|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||IU/mL||95% Confidence Interval|Geometric Mean
1381025|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
1381026|NCT01449747|Primary|Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1, total GLP-1 and total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurements were measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Comparisons were made using Area under the curve (AUC) values and incremental area under the curve (ΔAUC) of active GLP-1, total GLP-1 and total GIP before and after the addition of sitagliptin.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol*min/L||Standard Deviation|Mean
1381027|NCT01449747|Primary|Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment|Plasma concentrations of total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GIP were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol/L||Standard Deviation|Mean
1381028|NCT01449747|Primary|Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment|Plasma concentrations of total GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol/L||Standard Deviation|Mean
1381029|NCT01449747|Secondary|Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups|The DPP-4 activity was measured at baseline and 0, 15, 30, 45 and 60 min during the meal tolerance test. Second measurement of DPP-4 activity was measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Plasma DPP-4 activity during meal tolerance test is expressed as percentage activity relative to baseline. DPP-4 activity % was calculated using the following formula : (DPP-4 activity at time t / Baseline DPP-4 activity) × 100.|0, 15, 30, 45, 60 min post-dose||||percentage of DPP4 activity||Standard Deviation|Mean
1381030|NCT01449747|Primary|Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol/L||Standard Deviation|Mean
1381031|NCT01449734|Primary|Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score|Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making. After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied).|From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|By invitation|||units on a scale||Standard Deviation|Mean
1381032|NCT01449734|Secondary|Patient Mortality||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|||||||
1381033|NCT01449734|Secondary|Patient Length of Stay on the ICU||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|||||||
1381034|NCT01449734|Secondary|Patient Severity of Illness||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|||||||
1381035|NCT01449721|Secondary|Number of Participants With Experiencing Complications Related to Intravascular Volume Overload|"Composite safety endpoint:~Premature termination of the protocol-directed intravenous fluid administration by the investigator or primary physician due to presumed volume overload~Administration of intravenous diuretic for acute pulmonary edema~Respiratory failure requiring ventilatory assistance (BiPAP, CPAP, or mechanical ventilation) secondary to pulmonary edema per primary care team"|12 hours following treatment initiation||||Participants|||Count of Participants
1381036|NCT01449721|Secondary|In-hospital Mortality|Any occurrence of mortality while the participant is in-hospital is counted as an outcome.|In-hospital discharge or up to maximum 30 days||||Participants|||Count of Participants
1381037|NCT01449721|Primary|Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1|"Development of worsening organ failure defined by the Sequential Organ Failure Assessment (SOFA) score. The SOFA score defines the presence and severity of dysfunction within 6 organ systems (cardiovascular, respiratory, coagulation, liver, renal, and nervous system) with a value of 0 for assigned to normal function to a maximum value of 4 for severe dysfunction in each of the organ systems. Each component of the SOFA score is added together, ranging from 0 indicating no organ dysfunction in any of the 6 organ systems, to 24 indicating maximal organ dysfunction across all 6 organ systems.~Within this trial, the occurrence of organ failure was defined by any increase in the total SOFA score by ≥ 1 point over the first 72 hours after randomization."|72 hours||||Participants|||Count of Participants
1381038|NCT01449708|Secondary|PONV Between Different Surgical Procedures (Percentage of Participants)||24 hours|analysis was conducted with all participants and NOT per arm|||percentage of participants|||Number
1381039|NCT01449708|Secondary|Number of Patients Requiring Antiemetic Rescue Medication (AERM)||24hours||||participants|||Number
1381040|NCT01449708|Primary|PONV During the First 24 Hours After Bariatric Surgery|Postoperative Nausea and Vomiting|24 hours||||participants|||Number
1381041|NCT01449682|Secondary|To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups||baseline to 48 weeks||||microns||Standard Error|Mean
1381042|NCT01449682|Secondary|To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups||baseline to 48 weeks||||ETDRS letters||Standard Error|Mean
1381043|NCT01449682|Primary|Macular Function Using Multi-focal ERG|To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups|baseline to 48 weeks||||nV/deg2||Standard Error|Mean
1381044|NCT01449682|Primary|Macular Function Using Microperimetry|To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups|baseline to 48 weeks||||dB||Standard Error|Mean
1381045|NCT01449539|Primary|Number of Stem Cells Collected|Total stem cells collected from all participants at one week post-study treatment|one week post-treatment|Four of eight enrolled subjects completed the study.|||stem cells|||Number
1381048|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381049|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381050|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381051|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel,0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381052|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381053|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381054|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381055|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381056|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM(Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381057|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381058|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381059|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381060|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381112|NCT01449279|Secondary|Duration of Partial Response.|Length of time between first dose of ipilimumab and a partial response according to RECIST v1.1 (see above) and immune response criteria|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|all patients that did not have SAEs during treatment and did not have complete response.|||weeks||Full Range|Median
1385434|NCT01402115|Secondary|Changes in bALP(Bone-specific Alkaline Phosphatase)|bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||U/L||Standard Deviation|Mean
1381061|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381062|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381063|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381064|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381065|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381066|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381067|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381068|NCT01449513|Primary|Change in Degree of Infiltration|Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381313|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation|Number of participants who received an heart/lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.|||participants|||Number
1381069|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381070|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in Sub actinic keratosis (AK) skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
1381071|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in actinic keratosis (AK) skin.This RCM imaging technique is a relatively new non-invasive, real-time evaluation method to generate horizontal skin sections at a resolution comparable to routine histology.~The degree of infiltration of the epidermis by inflammatory cells will be based on “inflammation/small bright cells” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on “inflammatory cells in the dermis” (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage change||Standard Deviation|Mean
1381072|NCT01449461|Secondary|Intracranial Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression in brain, or death due to any cause, whichever occurs first. Intracranial PFS was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
1381073|NCT01449461|Secondary|Duration of Intracranial Response|Intracranial duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR in brain metastases (whichever is first recorded) until the first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at the last valid response assessment. Duration intracranial of response was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
1381074|NCT01449461|Secondary|Intracranial Objective Response Rate|Intracranial objective response rate is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 after the initiation of study drug. CR for target lesion: disappearance of all extranodal lesions. CR for non-target lesion: disappearance of all extranodal non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Meta.=Metastases.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure. Here, n is the number of participants who were evaluable for specific category.|||percentage of participants||95% Confidence Interval|Number
1381075|NCT01449461|Secondary|Overall Survival (OS)|OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
1381076|NCT01449461|Secondary|Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader). PFS was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here 'n' is participants analysed for each category.|||months||95% Confidence Interval|Median
1381168|NCT01447914|Secondary|Progression-free Survival (PFS)|Kaplan and Meier product limit methods will be used to estimate the median PFS with 95% confidence intervals. Furthermore, the univariate and multivariate Cox proportional hazards regression model will be used to identify prognostic factors for PFS.|From start of the treatment to disease progression or death (regardless of cause of death), whichever comes first, assessed up to 30 days|||||||
1381077|NCT01449461|Secondary|Duration of Response|Duration of response is defined as time interval from the time that measurement criteria are first met for CR/PR (whichever is first recorded) until first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at last valid response assessment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in SLD of target lesions. PD for target lesion: SLD increased by at least 20% from smallest value and must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|FAS. Participants who were responders among those who were had anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here 'n' is participants analysed for each category. Duration of response was calculated by Kaplan-Meier estimation.|||months||95% Confidence Interval|Median
1381078|NCT01449461|Secondary|Best Overall Response|Best overall response is defined as proportion of participants with CR, PR, stable disease (SD) or progressive disease (PD) as per of RECIST v1.1 as evaluated by investigator. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. Disease progression for target lesion: SLD increased by at least 20% from smallest value on study and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions. SD for neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1381079|NCT01449461|Secondary|Terminal Phase Elimination Half-life (T1/2) for Brigatinib||Cycle 2 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.|||hours||Standard Deviation|Mean
1381080|NCT01449461|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib||Cycle 1 Day 1, 8, 15 and 22 pre-dose and Day 1 multiple timepoints (up to 48 hours) post-dose; Cycle 2 Day 1 and 3 pre-dose and Day 1 multiple time points (up to 48 hours) post-dose|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.|||h*ng/mL||Standard Deviation|Mean
1381081|NCT01449461|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brigatinib||Cycle 2 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib.|||hour||Standard Deviation|Mean
1381082|NCT01449461|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brigatinib||Cycle 1 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.|||hours||Standard Deviation|Mean
1381083|NCT01449461|Secondary|Cmax: Maximum Observed Plasma Concentration for Brigatinib||Cycle 2 Day 2|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1381084|NCT01449461|Secondary|Cmax: Maximum Observed Plasma Concentration for Brigatinib||Cycle 1 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participant analyzed is the participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
1381085|NCT01449461|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs) Assessed in Dose Escalation Phase of the Study|DLT include any toxicity that is possibly, probably, or definitely drug-related. Toxicity grades will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLTs are defined by the following: A) Non-hematologic toxicities: Any grade ≥3 non-hematologic toxicity, with the exception of self-limiting or medically controllable toxicities (eg, nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting < 3 days, and excluding alopecia. B) Hematologic toxicities: Febrile neutropenia not related to underlying disease (fever, > 101°F; ANC<500); Prolonged grade 4 neutropenia (> 7 days); Neutropenic infection: ≥ grade 3 neutropenia with ≥ grade 3 infection; Thrombocytopenia ≥ grade 3 with bleeding or grade 4 lasting ≥ 7 days. C) Missed ≥ 25% of planned doses of brigatinib over 28 days due to treatment-related AEs in the first cycle.|Up to Cycle 1 (28 days)|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1381086|NCT01449461|Secondary|Maximum Tolerated Dose (MTD) Assessed in Dose Escalation Phase of the Study|The MTD is defined as the highest dose at which ≤ 1 of 6 evaluable participants experience a DLT within the first 28 days of treatment (end of cycle 1). Evaluable participants must complete at least 75% of their planned doses, unless missed doses are due to AEs. The cohort may be expanded to better define the safety profile for confirmation of the MTD. The maximum administered dose in the trial will likely exceed the MTD.|Up to Cycle 1 (28 days)|Safety population included all enrolled participants who received at least one dose of study drug. MTD was not formally determined.|||mg|||Number
1381087|NCT01449461|Secondary|Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Any adverse event reported on or after the day of first dose of study drug (approximately up to 50 months)|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
1381088|NCT01449461|Primary|Objective Response Rate (ORR)|ORR assessed by the investigator, is defined as the proportion of the participants with complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Crzb=Crizotinib.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set (FAS) included all participants who received at least one dose of study drug. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here, n is the number of participants who were evaluable for specific category.|||percentage of participants||95% Confidence Interval|Number
1381089|NCT01449461|Primary|Recommended Phase 2 Dose of Brigatinib|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of cycle 1).|28 days|Safety population included all enrolled participants who received at least one dose of study drug.|||mg||Full Range|Mean
1381090|NCT01449370|Secondary|Percent Change From Baseline in Pharmacodynamic Markers|"Pharmacodynamic markers included phosphorylated ribosomal protein S6 (PS6), phosphorylated eukaryotic initiation factor 4E-binding protein 1 (P4EBP1), phosphorylated N-myc downstream regulated gene 1 (PNDRG1), phosphorylated proline-rich AKT substrate of 40 kilodaltons (PPRAS40), and phosphorylated serine/threonine protein kinase AKT (PAKT). Analysis population (n) for each skin biopsy biomarker is as follow: P4EBP1 (n=6,6,6,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PAKT and PNDRG1 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 6,0,6,2,2,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PS6 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0).n for each tumor tissue biomarkers is as follow: P4EBP1, PAKT, PNDRG1, and PS6 (n=1,1,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 1,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0)."|Cycle 1 Day 8|Asat population where baseline and post-baseline assessments were available. The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||percent change||Standard Deviation|Mean
1381091|NCT01449370|Secondary|%AUC Extrapolated: Percentage of Area Under Concentration-extrapolated||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|No data is reported since serum concentration of TAK-117 were below the limit of quantification.||||||
1381092|NCT01449370|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|No data is reported since serum concentration of TAK-117 were below the limit of quantification.||||||
1381093|NCT01449370|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||nanogram hours per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1381094|NCT01449370|Secondary|T 1/2z: Terminal Disposition Phase Half-life for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||hrs||Standard Deviation|Mean
1381095|NCT01449370|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||hr||Full Range|Median
1381096|NCT01449370|Secondary|Ctrough: Observed Concentration at the End of Dosing Interval for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1381097|NCT01449370|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|Pharmacokinetic (PK) population included all participants who took at least 1 dose of study drug and had sufficient plasma concentration-time data to calculate PK parameters.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1381098|NCT01449370|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate was defined as the participants who achieved stable disease (SD) for at least 15 weeks, CR, or PR. The estimate of the CBR was calculated as crude percentage of participants whose best ORR was CR, PR or SD for at least 90 days.|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The FAS population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1381113|NCT01449279|Secondary|Duration of Complete Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|all subjects|||weeks||Full Range|Median
1381099|NCT01449370|Secondary|Duration of Objective Response|Duration of response was to be calculated for participants who achieved CR or PR. Duration of objective response was defined as the number of days from the start date of PR or CR (whichever response was achieved first) to the first date that PD or disease progression was objectively documented. The duration of objective response was to be right-censored for participants who achieved CR or PR and met 1 of the following conditions: Non-protocol anticancer treatment started before documentation of PD; Documented PD after more than 1 missed disease assessment visit; Alive and did not have documentation of PD before a data analysis cutoff date.|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The duration of objective response analysis was not performed due to change in planned analysis.||||||
1381100|NCT01449370|Secondary|Overall Response Rate (ORR)|The estimate of the ORR is calculated as crude percentage of participants who's best overall response is complete response (CR) or partial response (PR). Objective response (CR and PR) as determined by the participants best tumor response was assessed using response evaluation criteria in solid tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and progressive disease (PD).|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The full analysis set (FAS) population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1381101|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
1381102|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Vital Signs||Baseline up to Cycle 27 day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
1381103|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Laboratory Values||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
1381104|NCT01449370|Primary|Number of Participants With Highest Level of TEAEs Severity|Severity of AEs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 as follow: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening); Grade 5 (fatal).|Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
1381105|NCT01449370|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Death, Adverse Events (AEs) Leading to Discontinuation of Study Drug, and DLTs in Cycle 1||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
1381106|NCT01449370|Primary|Maximum Tolerated Dose (MTD) of TAK-117|MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for >14 days. Grade 3: nausea and/or vomiting/diarrhea for >7 days; rash for >7 days; thrombocytopenia with bleeding; fasting hyperglycemia for >24 hours(hr). Grade >=3:nonhematologic toxicity considered clinically significant by investigator. Grade 4:neutropenia (absolute neutrophil count <=0.5*10^9per liter[/L]) for >7 days in absence of growth factor support; neutropenia of any duration accompanied with fever >=38.5 degree Celsius and/or systemic infection. Grade >=4:hematologic toxicity. Inability to administer at least 75% of planned doses of TAK-117 within Cycle 1 due to its related toxicity;Any clinically significant occurrence that investigators and sponsor agreed would place participants at undue safety risk.|Baseline up to Cycle 1 Day 21|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||mg|||Number
1381107|NCT01449305|Other Pre-specified|Medicine Administration for Pain Relief During Study Period|Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.|first menstrual cycle, second menstrual cycle and third menstrual cycle|It was analyzed based on the PP population.|||percentage of participants|||Number
1381108|NCT01449305|Primary|The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline|The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).|baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle|Subjects were asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles in house. Primary objective was analyzed based on the Per-protocol (PP) population.|||scores||Standard Deviation|Mean
1381109|NCT01449279|Secondary|Progression-free Survival (PFS)|Median time to progression-free survival (PFS) was calculated using the Kaplan-Meier algorithm|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All subject who did not have SAEs during treatment.|||weeks||95% Confidence Interval|Median
1381110|NCT01449279|Secondary|Median Time to Complete Response or Partial Response|Time from the first dose of ipilimumab to the first tumor measurement showing either a complete or partial response to therapy.|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All patients who had either a complete response or partial response.|||weeks||95% Confidence Interval|Median
1381111|NCT01449279|Secondary|Stable Disease|Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All patients who did not have SAEs during treatment and did not reach complete response or partial response.|||weeks||Full Range|Median
1394776|NCT01313182|Secondary|Measure Hospital Length of Stay and Re-admission Rates in the Mupirocin and Povidone-iodine Groups.|Re-admission for infection within 12 months of procedure|12 months|||||||
1381115|NCT01449279|Secondary|Response Rate|"Compare tumor response rate and duration of response at unirradiated sites in patients with Stage IV melanoma with historical controls.~Response assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays:~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR"|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|All subjects.|||Participants|||Count of Participants
1381116|NCT01449279|Primary|Safety Measurement - Percentage of Patients Experiencing Serious Adverse Events (SAEs) in the First 4 Months of Treatment.|Serious adverse events (SAEs) defined as untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires in subject hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, may jeopardize the subject or may require intervention to prevent one of the other serious outcomes listed in the definition above.)|4 months|All subjects.|||Participants|||Count of Participants
1381117|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|The evaluation of the decrease in seric concentration of gadolinium, 4h after the third hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of detection were kept for analysis.|Dotarem® dialysability assessed 4h after third hemodialysis session which took place 4 days after Dotarem® administration|8 subjects had a gadolinium concentration <LLQ after third hemodialysis session|||percent change in Gd concentration||Full Range|Geometric Mean
1381118|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|Evaluation of the decrease in seric concentration of gadolinium, 4h after the second hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of quantification (LLQ) were kept for analysis.|Dotarem® dialysability assessed 4h after second hemodialysis session which took place 2 days after Dotarem® administration|3 subjects had a gadolinium concentration <LLQ after the second hemodialysis session|||Percent change in Gd concentration||Full Range|Geometric Mean
1381119|NCT01449266|Secondary|Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.|To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.|Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration||||participants|||Number
1381120|NCT01449266|Primary|Dialysability of Dotarem® in Dialysed Patients|To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)|Dotarem® dialysability assessed up to 4 days after Dotarem® administration|After second hemodialysis, 3 subjects had Gd concentration<LLQ and are not included in the analysis; after third hemodialysis, 8 subjects had Gd concentration<LLQ and are not included in the analysis|||percent change in Gd concentration||Full Range|Geometric Mean
1381121|NCT01449240|Secondary|Levels of GAG in Urine|The levels of GAG (including sulfated DS/HS oligosaccharides) in urine were determined by the Blyscan sulfated GAG assay kit. The concentration of GAG in urine was normalized to the urine creatinine value and reported as mg GAG/mmol creatinine.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. Urinary GAG was not measured in 2 patients: 1 pediatric patient who provided a retrospective CSF sample only (no urine sample was collected) and 1 adult patient whose CSF sample was not considered evaluable and therefore their urinary GAG was not measured.|||mg GAG/mmol Creatinine||95% Confidence Interval|Mean
1381122|NCT01449240|Primary|Levels of Total Glycosaminoglycan (GAG) in CSF|The concentration of total GAG, including heparan sulfate (HS) and dermatan sulfate (DS) oligosaccharides, in CSF was measured using an enzymatic assay.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. This included a pediatric patient who was consented to provide a retrospective CSF sample.|||ng/mL||95% Confidence Interval|Mean
1381123|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H2O as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.|||ratio||Standard Error|Least Squares Mean
1381142|NCT01448707|Secondary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol.|Week 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Percentage of Participants|||Number
1381124|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echot time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.|||ratio||Standard Error|Least Squares Mean
1381125|NCT01449006|Secondary|Change in CSF Neopterin Concentration|Change in concentration of the CSF neuroinflammatory marker neopterin (measured in nmol/L) from baseline to 12-months.|Baseline and 12-months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control and n=2 maraviroc who did not provide a CSF sample at 12-months.|||nmol/L||Standard Error|Least Squares Mean
1381126|NCT01449006|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6-months and 12-months|Modified intent-to-treat analysis. All randomized participants were included except for n=2 controls with baseline data only (1 lost to follow-up, 1 withdrew before 6-months) and n=1 control where a protocol violation was noted (randomized without conclusive evidence of neurocognitive impairment - see participant flow section).|||Global Neurocognitive Z-Score||Standard Error|Least Squares Mean
1381127|NCT01448850|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit|Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.|Day 1 up to Week 69|Immunogenicity (IM) population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum sample for IM testing.|||participants|||Number
1381128|NCT01448850|Secondary|Observed Serum Concentrations of MEDI8968||Pre-dose (Baseline), Post-dose on Week 53|PK population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum concentration.|||nanogram per milliliters (ng/mL)||Standard Deviation|Mean
1381129|NCT01448850|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to Week 69|Safety population included all participants who were randomized and received at least one dose of investigational product.|||participants|||Number
1381130|NCT01448850|Secondary|Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.|||percentage of participants|||Number
1381131|NCT01448850|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.|||units on a scale||Standard Error|Mean
1381132|NCT01448850|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total Score|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.|Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of participants|||Number
1381192|NCT01447446|Secondary|Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)||Up to 118 weeks|The data for this outcome measure were not collected and analyzed because the standard of care has changed significantly since the development of the study protocol, this comparison was no longer of practical value.||||||
1381133|NCT01448850|Secondary|Change From Baseline in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Error|Mean
1381134|NCT01448850|Secondary|Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.|||days||Inter-Quartile Range|Median
1381135|NCT01448850|Secondary|Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.|||AECOPD events/year||90% Confidence Interval|Mean
1381136|NCT01448850|Primary|Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.|||AECOPD events/year||90% Confidence Interval|Mean
1381137|NCT01448707|Secondary|Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results|The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL >400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.|Over 48 and 96 Weeks|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Participants|||Number
1381138|NCT01448707|Secondary|Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance|The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA >= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).|At Weeks 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Participants|||Number
1381139|NCT01448707|Secondary|Time to Loss of Virologic Response|Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA >= 50 copies/mL or premature discontinuation.|Baseline up to Week 96 or early withdrawal|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Days||Full Range|Median
1381140|NCT01448707|Secondary|Change From Baseline in Global Neurocognitive Performance z-Score|Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).|Baseline, Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Units on a Scale||Standard Error|Mean
1381141|NCT01448707|Secondary|Virologic Response (FDA Snapshot, Switch Included)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.|Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Percentage of Participants|||Number
1381261|NCT01446250|Primary|Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.||||||
1381143|NCT01448707|Primary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.|Week 48|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Percentage of Participants|||Number
1381144|NCT01448616|Secondary|Asymptomatic Shedding (Shedding on Days Without Genital Lesions)|"Within person changes in shedding on days without lesions between the lead-in (observational) phase and the study drug (treatment) phase. Each arm is evaluated separately and no inter arm comparisons are made.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|All randomized participants are included in ITT analysis. Per protocol analysis includes persons receiving 30 or more days of study drug with >90% adherence as documented by returned product counts.|||% days with asymptomatic shedding||95% Confidence Interval|Number
1381145|NCT01448616|Secondary|Genital Lesion Rate|"The within person change in proportion of days with lesions between the lead-in (observational) and study drug (treatment) phase for each arm separately. No between arm comparisons were performed. We include intent to treat with all randomized participants as well as per protocol (persons receiving study drug for at least 30 days with 90% or better reported compliance per returned product counts).~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase||||percentage of days with lesions (%)||95% Confidence Interval|Number
1381146|NCT01448616|Secondary|Within-person Changes in Log-copy Numbers of HSV|"The within-person changes in mean log-copy numbers of HSV shed during treatment phase (oral TDF, vaginal TFV, or double placebo) compared with the lead-in (observation) phase in the same participants. Each treatment arm is analyzed separately without comparison between arms.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|Analysis is within person changes such that the observational group contributed to analyses of those persons in each treatment randomization group|||log-copy number of HSV DNA shed||95% Confidence Interval|Mean
1381147|NCT01448616|Primary|HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo|The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms.|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|This includes intent to treat, ( all randomized participants) and per-protocol analyses (persons receiving 30 or more days of treatment with >90% compliance as recorded by returned product counts)|||percentage of swabs positive (%)||95% Confidence Interval|Number
1381148|NCT01448525|Secondary|Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score|The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.|Baseline, Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.|||Percentage of participants|||Number
1381149|NCT01448525|Primary|Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported."|Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.|||Percentage of participants|||Number
1381150|NCT01448486|Secondary|Cerebrospinal Fluid|To determine if there is improvement in CSF neopterin concentrations with the addition of Raltegravir.|Baseline and 12 months|Study was terminated prematurely with an incomplete study dataset before any meaningful analyses of the data could be conducted. CSF was not collected at 12 months for n=1 raltegravir and n=1 control who refused lumbar puncture.|||nmol/L||Standard Error|Mean
1381151|NCT01448486|Primary|Neurocognitive Function|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6 months and 12 months|Study was terminated prematurely with an incomplete study dataset any before any meaningful statistical analysis of the data (including change over the study time-points) could be performed.|||Global Neurocognitive Z-Score||Standard Error|Mean
1381152|NCT01448356|Secondary|Tear Film Break up Time|After instillation of fluorescein, the participant will then be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye.|20 minutes after the required temperature and humidity in the chamber is achieved||||seconds||95% Confidence Interval|Mean
1381153|NCT01448356|Primary|Tear Evaporation Rate|The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.|20 minutes after the required temperature and humidity in the chamber is achieved||||Watt/meter^2||95% Confidence Interval|Mean
1381154|NCT01448213|Secondary|Number of Eyes With Intraocular Pressure (IOP) Elevation|Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.|one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK||||eyes|Participants||Number
1381155|NCT01448213|Primary|Number of Eyes With Immunologic Graft Rejection Episodes||Within 1 year||||eyes|Participants||Number
1381156|NCT01448057|Secondary|Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms|Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms|Day 3|In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm|||mm||Standard Deviation|Mean
1381157|NCT01448057|Primary|Physician Global Evaluation of Effectiveness on Nasal Symptoms|"The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.~Range from 1 to 5 where 1 is excellent and 5 is bad :~1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms"|Day 2|In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm|||score on a scale||Standard Deviation|Mean
1381158|NCT01448044|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|From Day 1 (start of study treatment) up to Follow-up Week 4|Analysis was performed on all treated participants.|||participants|||Number
1381159|NCT01448044|Secondary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.|Post Treatment Weeks 12, 24|For SVR12; analysis was performed by backward imputation method, For SVR24: analysis was performed in Modified ITT population.|||Percentage of participants|||Number
1381160|NCT01448044|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels|Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48|The analysis was performed in modified ITT population.|||Percentage of participants||95% Confidence Interval|Number
1381161|NCT01448044|Secondary|Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)|Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48|The analysis was performed in modified ITT population.|||Percentage of participants||95% Confidence Interval|Number
1381162|NCT01448044|Primary|Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)|Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.|Week 12 (Follow-up period)|The analysis was performed in modified Intent to treat population (ITT), defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. Missing values were imputed using backward imputation technique.|||Percentage of participants||95% Confidence Interval|Number
1381163|NCT01447927|Secondary|Overall Adverse Event Rates|"Number of patients that experienced adverse events (grade 1 or above) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v. 4.0.~The data reported in the table include only the commonly occurring adverse events (3 or more events)."|Up to 30 days||||participants|||Number
1381164|NCT01447927|Primary|Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus|The percent change in pS6K1 was calculated as month 3 pS6k1 values minus baseline pS6k1 values, then divide by baseline pS6k1 values and multiply by 100.|Baseline to 3 months|Participants were considered evaluable for primary endpoint if pS6K1 data were available from both the pre- and post-intervention evaluations based on the intent-to-treat principle.|||percentage of change||Full Range|Median
1381165|NCT01447914|Post-Hoc|Cycles of Tivantinib Treatment Administered|Number of treatment cycles completed by study participants.|From start of participant treatment to completion or disease progression; Data collected for overall study period January 2012 to February 2014.||||number of treatment cycles||Full Range|Mean
1381166|NCT01447914|Secondary|Time to Next Treatment (TTNT)|Kaplan and Meier product limit methods will be used to estimate the TTNT with 95% confidence intervals.|From registration on trial to next treatment or death due to any cause, whichever comes first, assessed up to 30 days|||||||
1381167|NCT01447914|Secondary|Duration of Response|Kaplan and Meier product limit methods will be used to estimate the DOR with 95% confidence intervals.|From first observation of partial response to the time of disease progression, assessed up to 30 days|||||||
1381273|NCT01446159|Secondary|Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||day·kg·μg/mL/mg||Standard Deviation|Mean
1381169|NCT01447914|Primary|Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4|Toxicities with a grade 3 nonhematologic or grade 4 hematologic toxicities according to CTCAE, version 4. Grade 3 and estimated with a 95% credible interval. Summary statistics will be provided for continuous variables.|Up to 30 days|||||||
1381170|NCT01447914|Primary|Overall Response Rate (ORR)|ORR using International Myeloma Working Group Response Criteria, achieve at least a partial response (PR) or better: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR): CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour; Stable Disease (SD): Not CR, VGPR, PR or progressive disease; Progressive Disease (PD):>25% from lowest value Serum and/or Urine M-component, new lesions or soft tissue plasmacytomas, or hypercalcemia.|Up to 30 days|Proportion of participants reported on an intent-to-treat basis.|||participants|||Number
1381171|NCT01447849|Secondary|Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.|The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.|To provide 0.80 statistical power for detection of significance.|||Centipoises||Standard Error|Mean
1381172|NCT01447849|Primary|Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.|The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.|Number of participants was calculated to provide statistical power of 0.80 for detection of significance.|||mg/hour||Standard Error|Mean
1381173|NCT01447719|Other Pre-specified|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|at autopsy within 12 months of florbetapir PET scan|Includes only those subjects with time from scan to autopsy less than one year.|||florbetapir PET scans|||Number
1381174|NCT01447719|Other Pre-specified|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|at autopsy within 24 months of florbetapir PET scan||||florbetapir PET scans|||Number
1381175|NCT01447719|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|at autopsy within 24 months of florbetapir PET scan||||percentage of true positives/negatives||Full Range|Median
1381176|NCT01447719|Secondary|Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|18 of 46 subjects who died within 1 year of scan had no or sparse neuritic plaques at autopsy|||participants|||Number
1381177|NCT01447719|Secondary|Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|28 of 46 subjects who died within 1 year of scan had moderate to frequent neuritic plaques at autopsy|||participants|||Number
1381178|NCT01447719|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy within 24 months of florbetapir PET scan||||Correlation coefficient||95% Confidence Interval|Number
1381179|NCT01447719|Primary|Specificity Analysis in All Autopsy Population|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|20 of 59 subjects from the all autopsy population had no or sparse neuritic plaques at autopsy|||participants|||Number
1381180|NCT01447719|Primary|Sensitivity Analysis in All Autopsy Population|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|39 of 59 subjects from all autopsy population had moderate to frequent neuritic plaques at autopsy|||participants|||Number
1381191|NCT01447446|Secondary|Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)|Participants who prolonged the treatment period from 72 weeks were not reported.|Up to 72 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
1381181|NCT01447706|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Paclitaxel in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to Paclitaxel can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 3.9 years|Patients with available tissue for RNA-ISH analysis|||months PFS||95% Confidence Interval|Median
1381182|NCT01447706|Secondary|Overall Survival|To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, with a median of approximately 13 months||||months||95% Confidence Interval|Median
1381183|NCT01447706|Primary|Progression Free Survival|"To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 3.9 years||||months||95% Confidence Interval|Median
1381184|NCT01447576|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.|The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and atleast 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.|||Units on a scale||Standard Deviation|Mean
1381185|NCT01447576|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.|The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and at least 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.|||Units on a scale||Standard Deviation|Mean
1381186|NCT01447576|Primary|Participants With Adverse Events (AEs).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.|After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit|The primary safety dataset included all participants exposed to at least 1 dose of brexpiprazole.|||Participants|||Number
1381187|NCT01447511|Primary|Warfarin Clearance.|Warfarin enantiomer (S-warfarin and R-warfarin) clearance was measured in healthy volunteers genotyped for CYP2C9*1/*1, CYP2C9*1B/*1B, CYP2C9*1/*3, CYP2C9*2/*3 and CYP2C9*3/*3 to determine the magnitude of the warfarin-fluconazole (inhibition) and warfarin-rifampin (induction) drug interactions.|Over three (two for CYP2C9*1B/*1B participants) 12-16 day study periods.|Participants with the CYP2C9*1B/*1B haplotype did not participate in the fluconazole period (inhibition). One CYP2C9*1/*3 participant only completed the control period. One CYP2C9*2/*3 participant only completed the control and fluconazole (inhibition) study periods.|||mL/h||Standard Deviation|Mean
1381188|NCT01447446|Secondary|Percentage of Participants With Adverse Events (AE)|An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.|Up to 118 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
1381189|NCT01447446|Secondary|Percentage of Participants With Concomitant Medical Condition at Baseline||Baseline|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
1381190|NCT01447446|Secondary|Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)|Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).|Up to 72 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
1381193|NCT01447446|Secondary|Duration of Overall Treatment|Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.|Up to 118 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||Weeks||Standard Deviation|Mean
1381194|NCT01447446|Secondary|Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)|Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.|Up to 98 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
1381195|NCT01447446|Secondary|Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks|Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.|Up to 12 weeks|The data for all of the above mentioned virological responses were not collected and was not analyzed.||||||
1381196|NCT01447446|Secondary|Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions|SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.|Up to first 12 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
1381197|NCT01447446|Secondary|Virological Breakthrough|Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.|Up to EOT (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
1381198|NCT01447446|Secondary|Virological Relapse After End of Treatment|Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).|Up to 24 weeks after EOT (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
1381199|NCT01447446|Secondary|Virological Response at Various on Treatment Time Points and End of Treatment (EOT)|Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.|Week 4, 12 and End of treatment (EOT) (up to 96 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
1381244|NCT01446705|Primary|Effect of Health Information Exchange on Cost|Before after analysis of the presence of health information exchange on costs within the VA healthcare system; Measure is cost, unadjusted, in dollars for the year post enrollment in the health information exchange|2 Years|5269 individuals were excluded due to lacking cost information.|||$ per year unadjusted total VA cost||Standard Deviation|Median
1381245|NCT01446705|Primary|Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data|Determining rates of usage of healthcare by veterans by source of data. This will clue us into any differences in utilization patterns between groups.|2 years|Veterans divided into enrolled and non-enrolled in HIE groups|||participants|||Number
1381200|NCT01447446|Primary|Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)|SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.|12 weeks after end of treatment (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
1381201|NCT01447446|Primary|Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)|SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.|24 weeks after end of treatment (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
1381202|NCT01447433|Secondary|Change in Energy Intakes||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||kcal/d||Standard Deviation|Mean
1381203|NCT01447433|Secondary|Change in Fasting Plasma Insulin||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mIU/L||Standard Deviation|Mean
1381204|NCT01447433|Secondary|Change in Fasting Plasma Glucose||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mmol/L||Standard Deviation|Mean
1381205|NCT01447433|Secondary|Change in Lipid-lipoprotein Profile||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mmol/L||Standard Deviation|Mean
1381206|NCT01447433|Secondary|Change in Blood Pressure|Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mm Hg||Standard Deviation|Mean
1381207|NCT01447433|Secondary|Change in Waist, Abdominal and Hip Circumference|Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||cm||Standard Deviation|Mean
1381208|NCT01447433|Secondary|Change in Visceral Fat Area|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||cm^2||Standard Deviation|Median
1381209|NCT01447433|Secondary|Change in Fat Percentage|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||Percentage of body weight||Standard Deviation|Mean
1381210|NCT01447433|Secondary|Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||kg||Standard Error|Mean
1381211|NCT01447433|Primary|Change in Body Weight|Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||kg||Standard Deviation|Mean
1381212|NCT01447420|Secondary|Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12|Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.|From Baseline (Week 0) to Week 12|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline. Participants with available data at the time of evaluation were analyzed.|||participants|||Number
1381213|NCT01447420|Secondary|Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment|Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.|Up to Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.|||participants|||Number
1381258|NCT01446289|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth|GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|The analysis was done on the Immunogenicity Per Protocol Set (PPS), ie: all subjects in the enrolled population who correctly received the vaccine, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to un-blinding.|||µg/mL||95% Confidence Interval|Geometric Mean
1381214|NCT01447420|Secondary|Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression|Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.|Weeks 4, 12, 24, 48, 60 and 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.|||participants|||Number
1381215|NCT01447420|Primary|Percentage of Participants With Incidence of Anemia|Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.|Up to Week 72|Safety population included all enrolled participants who received at least one dose of any study medication.|||Percentage of participants||95% Confidence Interval|Number
1381216|NCT01447420|Primary|Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression|Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.|At Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at Baseline (Week 0).|||Percentage of participants||95% Confidence Interval|Number
1381217|NCT01447225|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction|||||||Number
1381218|NCT01447225|Secondary|Pharmacokinetics (AUClast)|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2).|Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion||||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
1381219|NCT01447225|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg).|Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion||||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1381220|NCT01447225|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 88.1 weeks||||participants with objective response|||Number
1381221|NCT01447225|Primary|To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies|To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 88.1 weeks||||participants reporting DLTs|||Number
1381222|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks||||mg/m2|||Number
1381312|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy|Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.|||participants|||Number
1381223|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks||||mg/m2|||Number
1381224|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin|"Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula~Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks||||target AUC (mg*min/mL)|||Number
1381225|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8"|From date of first dose to 30 days after termination, the longest 88.1 weeks|NOTE: Maximum tolerated dose is for the combination of gemcitabine and MM-121. MTD of MM-121 is provided in separate endpoint.|||mg/m2|||Number
1381226|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks|Note: data provided below is for MM-121 doses only for the combination. Combination therapy MTDs are provided in separate endpoint measures.|||mg/kg|||Number
1381227|NCT01447225|Primary|To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies|Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting|From date of first dose to 30 days after termination, the longest 88.1 weeks||||participants reporting adverse events|||Number
1381228|NCT01447121|Secondary|Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results.|1 hour|115 (115x1) test results are possible. Staff tested blood from 118 subjects (one of 3 test strip lots). All study results from 2 subjects were excluded from data analyses as already described. Also, one test exceeded time interval (defined in protocol) between meter test and reference method.|||BG test results|||Number
1381229|NCT01447121|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|115(115x1)test results are possible. 118 subjects tested one of 3 test strip lots on the BGM system. Study results from 2 subjects were excluded from all data analyses as already described. One subject test exceeded time interval (defined in protocol) between meter test and reference method.|||BG test results|Participants||Number
1381259|NCT01446250|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.|24 weeks post-treatment|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.||||||
1381230|NCT01447017|Primary|Adverse Events (AEs)|"AEs were collected by a non-leading question such as have you experienced any new health problems or worsening of existing conditions as well as reporting events directly observed or spontaneously volunteered by patients. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were recorded as an AE including the following information: Diagnosis; Start date (and time, if relevant), Stop date (and time, if relevant) or resolution; Severity; Action taken; Causality; Seriousness; Outcome."|"AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational medicinal product (IMP), previously reported AEs were followed up and assessed as recovered or not recovered."|All safety analyses were performed on safety analysis set. All randomised patients who received at least 1 dose of the IMP and had at least 1 safety follow-up performed were included in the safety analysis set.|||participants|||Number
1381231|NCT01446874|Secondary|Incidence of Fever||Within 24 hours of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.|||Participants|||Count of Participants
1381232|NCT01446874|Secondary|Postoperative Respiratory Failure|Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy|Within 30 days of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.|||Participants|||Count of Participants
1381233|NCT01446874|Secondary|Perioperative Mortality||Within 30 days of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.|||Participants|||Count of Participants
1381234|NCT01446874|Secondary|Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire|Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire|Within 30 days of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing and the participants did not complete the questionnaire.|||Participants|||Count of Participants
1381235|NCT01446874|Secondary|Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary||Within 30 days of surgery (comparing pre-op and post-op)|The Pilot Portion is not included in this outcome measure. 7 participants in the esophageal resection group was not evaluable for this outcome measure and 10 participants in the lung resection group were not evaluable for this outcome measure.|||Participants|||Count of Participants
1381236|NCT01446874|Primary|Adherence to the Pre-operative Toothbrushing Regimen|-This is for pilot portion of study only|Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)||||Participants|||Count of Participants
1381237|NCT01446874|Primary|Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients|"Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery;~Fever (Temperature >38.2 C)~Leucocytosis (WBC>12,000/cu mm)~New infiltrate on chest X-ray~Positive sputum or bronchial culture~Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons’ database."|Within 30 days of surgery|-None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing. 25 participants were not considered evaluable for this outcome measure (21 from lung resection and 4 from esophageal resection)|||Participants|||Count of Participants
1381238|NCT01446796|Secondary|Functional Capacity and Symptoms|To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.|14 days|Study terminated early due to low accrual. No data analysis completed.||||||
1381239|NCT01446796|Secondary|Right Ventricular Function|To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.|14 days|Study terminated early due to low accrual. No data analysis completed.||||||
1381240|NCT01446796|Secondary|Post-operative Need for Hemodynamic / Respiratory Support|To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.|14 days|Study terminated early due to low accrual. No data analysis completed.||||||
1381241|NCT01446796|Primary|Length of Hospitalization|To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.|14 days|Study terminated early||||||
1381242|NCT01446705|Secondary|Health Care Quality: Care Sensitive Admissions|This study will use the Agency for Healthcare Research and Quality's (AHRQ) Prevention Quality Indicators (PQI) to calculate the outcome measure. The PQIs are a set of measures used with hospital inpatient data to identify ambulatory care sensitive conditions. The PQIs consist of 14 conditions. The study will adopt 12 that are commonly used for adult patients: angina, asthma, bacterial pneumonia, chronic obstructive pulmonary disease, congestive heart failure, dehydration, diabetes long-term complications, diabetes short-term complications, diabetes uncontrolled, hypertension, lower-limb amputation among diabetes patients, and urinary infection.|3 years||2016-12-31|12/2016||||
1381243|NCT01446705|Primary|Health Care Quality: Ambulatory Care Performance Measures|This study will measure the impact of HIE upon health care quality the underuse of ambulatory care services. Measurements of underuse before and after implementation will detect improvements in the quality of care. To measure underuse, the study employs a measurement set that is sensitive to the potential effects and feasible for electronic data capture. 15 measures have been chosen, falling in the areas of prevention, diabetes, asthma, cardiovascular disease, congestive heart failure, mental health and osteoporosis.|3 years||2016-12-31|12/2016||||
1398809|NCT01274559|Secondary|Percent Change From Baseline in Triglyceride (TG) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1381246|NCT01446419|Secondary|Change in ODI From Baseline to 6 Months Post-treatment|"The improvement in ODI at 6 months compared to baseline.~ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|6 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.|||units on a scale||95% Confidence Interval|Least Squares Mean
1381247|NCT01446419|Secondary|Patient Success at 3 Months|"Proportion of subjects with clinical success at 3 months, where clinical success was defined as:~3 month ODI score represented at least a 15-point reduction from baseline~no device or procedure related SAE between baseline and 3 mos.~no increase in opioid use between procedure and 3 mos.~no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.~no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.|||percentage of patients|||Number
1381248|NCT01446419|Primary|Change in ODI From Baseline to 3 Months Post-treatment|"The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.~ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.|||units on a scale||95% Confidence Interval|Least Squares Mean
1381249|NCT01446289|Secondary|Percentages of Infants Reporting SAEs|Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.|From birth until study termination|The analysis was done on the Safety Set.|||Percentages of subjects|||Number
1381250|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)|Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician’s visit, AEs leading to withdrawal are reported.|All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician’s visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.|The analysis was done on the Safety Set.|||Percentages of subjects|||Number
1381251|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.|From day 1 to 7 after vaccination|The analysis was done on the Safety Set, ie, all subjects in the enrolled population who received a study vaccination, provided post vaccination safety data, provided post-baseline safety data.|||Percentages of subjects|||Number
1381252|NCT01446289|Secondary|Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization|Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.|1 month after the last routine infant immunization|The analysis was done on the Immunogenicity PPS.|||Percentages of subjects||95% Confidence Interval|Number
1381253|NCT01446289|Secondary|GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth|GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.|Day 91 after birth|The analysis was done on the Immunogenicity PPS.|||Ratio||95% Confidence Interval|Geometric Mean
1381254|NCT01446289|Secondary|GMC (ELISA) of Anti-GBS CPS Antibodies in Infants|GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.|Day of birth and day 91 after birth|The analysis was done on the Immunogenicity PPS.|||μg/mL||95% Confidence Interval|Geometric Mean
1381255|NCT01446289|Secondary|Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects|GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.|Day 31, day of delivery, day 91 post-delivery|The analysis was done on the Immunogenicity PPS.|||Ratio|Participants|95% Confidence Interval|Geometric Mean
1381256|NCT01446289|Secondary|GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects|GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.|Day 1, day 31 and day 91 post-delivery|The analysis was done on the Immunogenicity PPS.|||µg/mL||95% Confidence Interval|Geometric Mean
1381257|NCT01446289|Primary|Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery|The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|The analysis was done on the Immunogenicity PPS.|||Ratio||95% Confidence Interval|Geometric Mean
1381260|NCT01446250|Secondary|Percentage of Participants With Emergence of Resistant Mutations||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.||||||
1381262|NCT01446237|Secondary|Mean Change in ISGA From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1381263|NCT01446237|Secondary|Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles).|||Lesions||Standard Deviation|Mean
1381264|NCT01446237|Primary|Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit|The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions).|Week 1, 2, 4, 8 and 12|ITT population.|||Participants|||Number
1381265|NCT01446237|Primary|Number of Participants With a Minimum 2-grade Improvement of Investigator’s Static Global Assessment (ISGA) From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at that particular time points were analyzed.|||Participants|||Number
1381266|NCT01446237|Primary|Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|Intent-to-treat (ITT) population consisted of all participants that were enrolled in the study. Only those participants with data available at the indicated time points were analyzed.|||Percent change in lesions||Standard Deviation|Mean
1381267|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573|Participants With Positive ADA to MEDI-573 are reported.|Pre-infusion on Day 1 of each cycle, End of Treatment, Day 30, 60 and 90 post treatment (approximately 6 years)|Participants who received MEDI-573 and were analysed per the treatment they actually received were analysed for this outcome measure.|||Participants|||Count of Participants
1381268|NCT01446159|Secondary|Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II|The mean concentration profiles of both IGF-I and IGF-II post administration of MEDI-573 in plasma were evaluated during treatment.|Baseline (Cycle1 Day1 pre-dose), end of treatment (EOT), and 60 days post last dose (Approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received. Participants with free IGF concentration were analysed.|||ng/mL||Standard Deviation|Mean
1381269|NCT01446159|Secondary|Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1|The elimination half-life (t1/2) is the time measured for the serum concentration of MEDI-573 to decrease by 1 half to its original concentration.|Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||Day||Standard Deviation|Mean
1381270|NCT01446159|Secondary|Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).|Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||mL/day/kg||Standard Deviation|Mean
1381271|NCT01446159|Secondary|Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||Day||Full Range|Median
1381272|NCT01446159|Secondary|Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||μg/mL||Standard Deviation|Mean
1398810|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1381274|NCT01446159|Secondary|Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||μg·day/mL||Standard Deviation|Mean
1381275|NCT01446159|Secondary|Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||μg·day/mL||Standard Deviation|Mean
1381276|NCT01446159|Secondary|Phase 2: Change in Tumor Size||From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Centimeters||Standard Deviation|Mean
1381277|NCT01446159|Secondary|Phase 2: Overall Survival (OS)|Overall survival (OS) was measured from treatment start until death.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
1381278|NCT01446159|Secondary|Phase 2: Time to Progression (TTP)|Time to progression was measured from treatment start until the first documentation of disease progression. The PD was defined as >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
1381279|NCT01446159|Secondary|Phase 2: Duration of Response (DR)|Duration of response (DR) is measured from the first documentation of disease response to the first documented progressive disease and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
1381280|NCT01446159|Secondary|Phase 2: Time to Response|Time to response was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR. The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
1381281|NCT01446159|Secondary|Phase 2: Objective Response Rate (ORR)|The ORR was defined as percentage of participants with confirmed complete response or confirmed partial response, where CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was definded as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Percentage of participants||95% Confidence Interval|Number
1381282|NCT01446159|Secondary|Phase 2: Number of Participants With Best Overall Tumor Response|Tumor evaluation was based on RECIST v1.1 by CT or MRI scan as: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion; not evaluable (NE): either no or only a subset of lesion measurements are made at an assessment.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Participants|||Count of Participants
1381283|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs|An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
1381294|NCT01446003|Secondary|Trough Plasma Concentration (Ctrough) of MK-8457|The lowest plasma concentration reached by the drug prior to the next administration was determined for Day 1 (after initial dosing) and Day 10 (after multiple dosing). The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; pre-AM dose on Day 5 or 6|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Ctrough).|||nM||Geometric Coefficient of Variation|Geometric Mean
1381284|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs|An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
1381285|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
1381286|NCT01446159|Primary|Phase 2: Progression-free Survival (PFS)|"Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first.~The PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion."|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||95% Confidence Interval|Median
1381287|NCT01446159|Primary|Phase 1b: Number of DLTs|The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.|Up to Day 21 of Cycle 1|Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).|||DLT events|||Number
1381288|NCT01446159|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)|The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.|Up to Day 21 of Cycle 1|Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).|||Participants|||Count of Participants
1381289|NCT01446159|Primary|Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
1381290|NCT01446042|Secondary|Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90|"To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90:~A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed~A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed~No analyzed participants with a Cmax (maximum testosterone concentration) >2500 ng/dL"|90 days|ITT subjects who have a Cmax value at the specified visit.|||Participants|||Count of Participants
1381291|NCT01446042|Primary|Serum Testosterone Cavg|The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)|90 days|Per-Protocol Population|||Participants|||Count of Participants
1381292|NCT01446003|Primary|Number of Participants Who Discontinued the Study Medication Due to an AE|An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 70 days|The safety population consisted of all participants who received at least one dose of the investigational drug.|||Participant|||Number
1381293|NCT01446003|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 70 days|The safety population consisted of all participants who received at least one dose of the investigational drug.|||Participant|||Number
1381295|NCT01446003|Secondary|Time to Maximum Concentration (Tmax) of MK-8457|Tmax was determined for the AM dose on Day 1 and Day 10. The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Tmax).|||hr||Full Range|Median
1381296|NCT01446003|Secondary|Maximum Concentration (Cmax) of MK-8457|Maximum plasma concentrations of MK-8521 were determined for the AM dose on Day 1 and Day 10. The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Cmax).|||nM||Geometric Coefficient of Variation|Geometric Mean
1381297|NCT01446003|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12hr) of MK-8457|AUC0-12hr is an estimate of total plasma exposure to study drug over the dosing interval (12hr). Plasma concentrations of MK-8457 were determined on Day 1 (after initial dosing) and Day 10 (after multiple dosing). The placebo group is not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (AUC0-12hr).|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
1381298|NCT01446003|Secondary|Change From Baseline to Day 10 in Maximum Moving Average (maxMAΔ) Blood Pressure Measured Over 4 Hours|The effect of drug on resting blood pressure was estimated using maxMAΔ. The maxMAΔ in blood pressure was calculated as the maximum moving average change from baseline to Day 10 of 3 consecutive 15-minute blood pressure measurements across the first 4 hours after the morning (AM) and evening (PM) doses. In this method, the LS means of three consecutive time points over the 4 hour period were determined and the maximum LS mean was used for the endpoint. Blood pressure was determined using continuous monitoring at rest. Increased values represent an increase in hypertensive severity.|Up to 4 hours postdose on Days 1 and 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (maxMAΔ in blood pressure).|||mmHg||95% Confidence Interval|Least Squares Mean
1381299|NCT01446003|Secondary|Change From Baseline to Day 10 in 24-hour Mean Ambulatory Diastolic Blood Pressure (DBP)|DBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour LS mean ambulatory DBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour DBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.|Baseline and Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (change in 24-hour mean ambulatory DBP).|||mmHg||95% Confidence Interval|Least Squares Mean
1381300|NCT01446003|Primary|Change From Baseline to Day 10 in 24-hour Mean Ambulatory Systolic Blood Pressure (SBP)|SBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour least squares (LS) mean ambulatory SBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour SBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.|Baseline and Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (change in 24-hour mean ambulatory SBP).|||mmHg||95% Confidence Interval|Least Squares Mean
1381301|NCT01445951|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set|||percentage of participants|||Number
1381302|NCT01445951|Other Pre-specified|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/Subject-Month|||Number
1381303|NCT01445951|Other Pre-specified|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/Subject-Month|||Number
1381304|NCT01445951|Other Pre-specified|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population|||percentage of participants|||Number
1381305|NCT01445951|Other Pre-specified|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population|||percentage of participants|||Number
1381306|NCT01445951|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set (subjects with data available at Baseline and at Week 24)|||kg||Standard Error|Least Squares Mean
1381307|NCT01445951|Secondary|Mean 7-point Glucose Week 24 Values||Week 24|Full analysis set|||mg/dL||Standard Deviation|Mean
1381308|NCT01445951|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point glucose at baseline|Baseline|Full analysis set|||mg/dL||Standard Deviation|Mean
1381309|NCT01445951|Secondary|FPG Change From Baseline to Week 24|Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)|Baseline to Week 24|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
1381310|NCT01445951|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Safety population|||Liters||Standard Error|Least Squares Mean
1381311|NCT01445951|Primary|Change From Baseline to Week 24 in HbA1c|Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24|Baseline to Week 24|Full analysis set|||Percent of hemoglobin||Standard Error|Least Squares Mean
1381314|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation|Number of participants who received an lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.|||participants|||Number
1381315|NCT01445873|Secondary|Number of Hospitalizations|All hospitalizations during the follow-up period recorded in medical records.|Day 1 to Month 6|FAS|||hospitalizations||95% Confidence Interval|Mean
1381316|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality|Number of participants who died during the follow-up period.|Day 1 to Month 6|FAS|||participants|||Number
1381317|NCT01445873|Secondary|Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening|Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class.|Day 1 to Month 6|FAS|||months||Standard Deviation|Mean
1381318|NCT01445873|Secondary|Change From Baseline in Percent of Predicted Peak VO2|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.|||percent Vo2||95% Confidence Interval|Mean
1381319|NCT01445873|Secondary|Change From Baseline in Borg Dyspnoea Score|Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum). Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.|||units on a scale||95% Confidence Interval|Mean
1381320|NCT01445873|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)|6MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and 1 value recorded during follow-up period.|||meters||95% Confidence Interval|Mean
1381321|NCT01445873|Secondary|Change From Baseline in Tricuspid Regurgitant Velocity|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.|||m/sec||95% Confidence Interval|Mean
1381322|NCT01445873|Secondary|Change From Baseline in Tei Index|Difference between pre-index and follow-up value. Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.|||ratio||95% Confidence Interval|Mean
1381323|NCT01445873|Secondary|Change From Baseline in Cardiac Output|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.|||L/min||95% Confidence Interval|Mean
1381324|NCT01445873|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.|||Dyn/s/cm5||95% Confidence Interval|Mean
1381325|NCT01445873|Secondary|Change From Baseline in Left Ventricular End Diastolic Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values for this outcome measure.|||mm Hg||95% Confidence Interval|Mean
1381326|NCT01445873|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up values.|||mm Hg||95% Confidence Interval|Mean
1381327|NCT01445873|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values reported for this outcome measure.|||mm Hg||95% Confidence Interval|Mean
1381328|NCT01445873|Secondary|Change From Baseline in Mean Right Atrial Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 value recorded during follow-up period.|||mm Hg||95% Confidence Interval|Mean
1381329|NCT01445873|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension|Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.|Baseline to Month 6|FAS; N=number of participants with pre-index (prior to Thelin initiation) and ≥ 1 WHO value recorded during follow-up.|||participants|||Number
1381330|NCT01445873|Secondary|Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications|Use of PAH-related medications other than Thelin described by class of agent received.|Day 1 to Month 6|FAS|||percentage of participants|||Number
1381331|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage|Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.|Day 1 to Month 6|FAS|||mg||95% Confidence Interval|Mean
1381332|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed|Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.|Day 1 to Month 6|Not analyzed: duration of Thelin therapy as number of therapy days dispensed was not summarized; this measure was reported as duration in months only.|||days||Standard Deviation|Mean
1381333|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration|Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.|Day 1 to Month 6|FAS; participants without evidence of discontinuation of Thelin therapy were censored at the end of follow-up (at 6 months or death if prior to 6 months).|||months||Standard Deviation|Mean
1381334|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation|Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.|Day 1 to Month 6|FAS|||participants|||Number
1381335|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching|Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.|Day 1 to Month 6|FAS|||participants|||Number
1381336|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation|Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.|Day 1 to Month 6|Full analysis set (FAS): participants with idiopathic pulmonary arterial hypertension (PAH) or PAH secondary to connective tissue disease, receipt of Thelin for treatment of PAH, 6 months of follow-up (except for death) after initial receipt (IR) of Thelin, and at least 1 clinic visit in medical record during 6-month period after IR of Thelin.|||months||Standard Deviation|Mean
1381337|NCT01445847|Primary|Number of Patients With Laryngospasm Postoperatively|"There were 4 scores of laryngospasm:~0 = No Laryngospasm~= Stridor or partial laryngospasm~= Complete Laryngospasm~= Cyanosis"|within first 15 minutes post‐dose|Trial was terminated by data monitoring committee due to safety concerns|||participants|||Number
1381338|NCT01445769|Other Pre-specified|Dose Distribution at Week 24|Average Daily Dose for the last 28 days on study.|Week 24|Intent-to-treat population: All enrolled participants.|||participants|||Number
1381339|NCT01445769|Secondary|Number of Participants With Grade 3 or Grade 4 Adverse Events||Baseline to the end of the study|Safety population: All participants who took at least 1 dose of study drug.|||participants|||Number
1381340|NCT01445769|Secondary|Median Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]).|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Full Range|Median
1381341|NCT01445769|Secondary|Mean Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]), each on a scale of 0 to 10. A higher score indicates worse symptoms. A negative change score indicates improvement. The Baseline abdominal symptom score was the mean of daily abdominal symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 30. The Week 24 abdominal symptom score was the mean of the daily abdominal symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 30.|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
1381342|NCT01445769|Secondary|Percentage of Participants With Clinically Notable Anemia|Clinically Notable Anemia was a pre-specified safety parameter examined at Weeks 12, 18 and 24 and defined as: 1) New onset Grade 3 or higher anemia in subjects who are transfusion independent at Baseline, 2) New onset transfusion dependence in subjects who are transfusion independent at Baseline, defined as receipt of ≥ 2 units in ≤ a 12-week interval, 3) 50% increase in transfusions compared to Baseline in subjects who are transfusion dependent at Baseline.|Baseline to Weeks 12, 18 and 24|Safety population: All participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
1381343|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Their Transfusion Status or With New Transfusion Independence Status for Those Participants Who Were Transfusion Dependent at Baseline|"Transfusion dependence at Baseline is defined as subjects who received ≥ 2 units of red blood cell product(s) in the 12 consecutive weeks prior to the date of first dose.~Transfusion independence On-Study is defined as subjects who received 0 units of red blood cell products over any 12-week period after starting dosing with ruxolitinib.~Improvement in transfusion dependence On-Study is defined as a 50% or greater reduction in the frequency of red blood cell transfusions over any 12-week period after starting dosing with ruxolitinib."|Baseline to Week 24|Intent-to-treat population: All enrolled participants who were transfusion dependent at baseline (n=15).|||Percentage of participants||95% Confidence Interval|Number
1381344|NCT01445769|Secondary|Median Percent Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.|||Percentage change||Full Range|Median
1381345|NCT01445769|Secondary|Mean Percentage Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
1381368|NCT01445613|Secondary|Clinical Success|Clinical success is defined as the attainment of < 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.|30 days|FAS population|||percentage of participants||95% Confidence Interval|Number
1381346|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
1381347|NCT01445769|Secondary|Percentage of Participants With a ≥ 10% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
1381348|NCT01445769|Secondary|Percentage of Participants With a ≥ 35% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
1381349|NCT01445769|Secondary|Median Percent Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily TSS was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Full Range|Median
1381350|NCT01445769|Secondary|Mean Percentage Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0). Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score (TSS) was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline TSS was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 TSS was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
1381351|NCT01445769|Primary|Median Percent Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.|||: Percentage change||Full Range|Median
1381366|NCT01445626|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.|||Letters||Standard Deviation|Mean
1400707|NCT01258049|Secondary|PRR 24 [MITT Population]|The percentage reduction in parasite counts 24 hours after first dose|28 days after start of treatment||||percentage of baseline||Standard Deviation|Mean
1381352|NCT01445769|Primary|Mean Percentage Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
1381353|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit|LFU; 38 to 45 days after first study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.|||percentage of subjects|||Number
1381354|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit.|LFU; 38 to 45 days after first study drug administration|MITT: Randomized patients, with baseline pathogen.|||percentage of subjects|||Number
1381355|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.|||percentage of subjects|||Number
1381356|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|MITT: Microbiological Intent-to-Treat: Randomized patients, with baseline pathogen.|||percentage of subjects|||Number
1381357|NCT01445678|Secondary|The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population|Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen|TOC; 26-30 days after start of study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.|||percentage of subjects|||Number
1381358|NCT01445678|Primary|The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population|Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|TOC; 26-30 days after start of study drug administration|MITT: Randomized patients, with baseline pathogen.|||percentage of subjects|||Number
1381359|NCT01445652|Primary|Subjective Vision With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.|||Units on a scale||Standard Deviation|Mean
1381360|NCT01445652|Primary|Subjective Happiness With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.|||Units on a Scale||Standard Deviation|Mean
1381361|NCT01445626|Secondary|Time to Improvement of 3 Lines or More in BCVA|Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.|||Days||Full Range|Median
1381362|NCT01445626|Secondary|Time to Improvement of 2 Lines or More in BCVA|Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.|||Days||Full Range|Median
1381363|NCT01445626|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.|||µm||Standard Deviation|Mean
1381364|NCT01445626|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.|||Percentage of participants|||Number
1381365|NCT01445626|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.|||Percentage of participants|||Number
1381369|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|365 days|FAS population|||percentage of participants|||Number
1381370|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|180 days|FAS population|||percentage of participants|||Number
1381371|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|30 days|FAS population|||percentage of participants|||Number
1381372|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age||365 days|FAS population|||percentage of participants|||Number
1381373|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Age||30 days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.|||percentage of participants||95% Confidence Interval|Number
1381374|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status||365 days|FAS population|||percentage of participants|||Number
1381375|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Symptomatic Status||30 days|FAS population|||percentage of participants||95% Confidence Interval|Number
1381376|NCT01445613|Primary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days||365 days|FAS population|||percentage of participants|||Number
1381377|NCT01445613|Secondary|Death and All Stroke||30 Days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.|||percentage of participants||95% Confidence Interval|Number
1381378|NCT01445613|Primary|Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)||0 to 365 days|FAS population|||percentage of participants||Standard Error|Mean
1381379|NCT01445548|Secondary|Development of Exudative Age-Related Macular Degeneration (AMD) as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline||Baseline and 12 Months|||||||
1381380|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio|Participants|Standard Deviation|Mean
1381381|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio|Participants|Standard Deviation|Mean
1381382|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio|Participants|Standard Deviation|Mean
1381383|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12||||Ratio|Participants|Standard Deviation|Mean
1381384|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss.The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Participants|Standard Deviation|Mean
1381385|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Participants|Standard Deviation|Mean
1381386|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Participants|Standard Deviation|Mean
1381387|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Participants|Standard Deviation|Mean
1381388|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.|||MPS DA|Participants|Standard Deviation|Mean
1381389|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.|||MPS DA|Participants|Standard Deviation|Mean
1381390|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12||||Ratio||Standard Deviation|Mean
1381391|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio||Standard Deviation|Mean
1381392|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Participants|Standard Deviation|Mean
1381393|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Participants|Standard Deviation|Mean
1400708|NCT01258049|Secondary|PCT 50 [MITT Population]|Time for parasite counts to fall by 50%|28 days after start of treatment||||hours||Standard Deviation|Mean
1381394|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||ETDRS letters|Participants|Standard Deviation|Mean
1381395|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||ETDRS letters|Participants|Standard Deviation|Mean
1381396|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2/month|Participants|Standard Deviation|Mean
1381397|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2/month|Participants|Standard Deviation|Mean
1381398|NCT01445301|Secondary|Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12|Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).|Baseline (Day 1) and Week 1, 2, 4, 8 and 12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X. X, X in the category titles).|||Score on scale||Standard Deviation|Mean
1381399|NCT01445301|Secondary|Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12|Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).|Baseline (Day 1) and Week 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).|||Score on scale||Standard Deviation|Mean
1381400|NCT01445301|Secondary|Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)|MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.|Baseline (Day 1) and Week12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).|||Micrograms/milliliter|||Number
1381401|NCT01445301|Secondary|Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions|The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.|Baseline (Day 1) and Week 1, 2, 4, 8, and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Percentage of participants||95% Confidence Interval|Number
1381402|NCT01445301|Secondary|Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12|Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.|Week 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).|||Percentage of participants||95% Confidence Interval|Number
1381412|NCT01444911|Secondary|FACT-G Score|The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported.|At baseline and 6 months||||units on a scale||Full Range|Mean
1381472|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381403|NCT01445301|Secondary|Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator’s Static Global Assessment (ISGA) Score|Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.|Baseline (Day 1) and Week 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Percentage of Participants||95% Confidence Interval|Number
1381404|NCT01445301|Secondary|Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)|Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Least Squares Mean
1381405|NCT01445301|Secondary|Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.|Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Lesion count||Standard Error|Least Squares Mean
1381406|NCT01445301|Secondary|Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.|Baseline (Day 1) and Weeks 1, 2, 4, and 8|ITT population. Only those participants available at the specified time points were analyzed.|||lesion count||Standard Deviation|Mean
1381407|NCT01445301|Primary|Absolute Change From Baseline to Week 12 in Total Lesion Counts.|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.|Baseline (Day 1) and Week 12|ITT population. Only those participants available at the indicated time points were analyzed.|||lesion count||Standard Error|Least Squares Mean
1381408|NCT01445028|Primary|Rate of Retinal Attachment|We will evaluate all patients for retinal attachment at 3 months.|3 months||||Participants|||Count of Participants
1381409|NCT01444924|Secondary|Pain Scores|Pain scores by the Visual Analog Scale (VAS) [0-5, where 0 is no pain and 5 is extreme] and Wisconsin Brief Pain Inventory (BPI) [where 0 is no pain and 10 is the most painful], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score.|from 2 hours post-op to the afternoon/evening of post-op day #1||||units on a scale||95% Confidence Interval|Mean
1381410|NCT01444924|Primary|24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents||24 hours||||mg||Standard Deviation|Mean
1381411|NCT01444911|Secondary|Vaginal Length|Change in vaginal length as measured from baseline to 6 months.|At baseline and 6 months||||Centimeters||Full Range|Mean
1385435|NCT01402115|Secondary|Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)|CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||µg/L||Standard Deviation|Mean
1381413|NCT01444911|Secondary|Change in Marinoff Scale at 6 Months|"The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale:~0 = no pain with intercourse~= pain with intercourse that doesn't prevent the completion~= pain with intercourse requiring interruption or discontinuance~= pain with intercourse preventing any intercourse~Difference in Marinoff scores reported, value at 6 months minus value at baseline."|At baseline and 6 months|Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.|||units on a scale||Full Range|Mean
1381414|NCT01444911|Primary|Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months|Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.|At baseline and 6 months||||Units on a scale||Full Range|Mean
1381415|NCT01444898|Primary|Appetite Scores|"Appetite scores using a syndrome-validated hyperphagia questionnaire~11 item questionnaire divided into subcategories of behavior (5 questions), drive (4 questions), severity (2 questions). Tallied and analyzed as total and subcategory scores. Each question scored 1-5 with higher scores correlating with worse hyperphagia.~Possible ranges: Total 11-55, behavior 5-25, drive 4-20, severity 2-10"|6 months||||units on a scale||Standard Deviation|Mean
1381416|NCT01444898|Primary|Change in Pancreatic Peptide (PP)||6 months||||pg ml^-1||Standard Deviation|Mean
1381417|NCT01444898|Primary|Change in Acy Ghr||6 months||||pg ml^-1||Standard Deviation|Mean
1381418|NCT01444898|Primary|Change in Leptin||6 months||||ng ml^-1||Standard Deviation|Mean
1381419|NCT01444898|Primary|Change in Insulin Levels||6 months||||u/U ml^-1||Standard Deviation|Mean
1381420|NCT01444898|Primary|Change in HbA1c (%)||6 months||||percentage||Standard Deviation|Mean
1381421|NCT01444898|Primary|Change in BMI Z-Score||6 months||||units on a scale||Standard Deviation|Mean
1381422|NCT01444898|Primary|% Change in Body Mass Index (BMI)|Prior to analysis, distributions were evaluated for normality and natural log transformation was performed to analyse data not normally distributed. Data are presented as mean ±SD unless not normally distributed, in which case they are presented as median with intra-quartile ranges (25th and 75th percentiles). Within-subject changes between visits were analysed by mixed model repeated measures. When the overall F-test for difference among visits was significant, Dunnett-adjusted pairwise comparisons were made between baseline and each subsequent visit.|6 months||||% change in BMI||Standard Deviation|Mean
1381423|NCT01444898|Primary|Change in Weight|Change in weight (kg) after 6 months of treatment with study drug. Described as mean +/- SD|6 months||||kg||Standard Deviation|Mean
1381424|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1381425|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received the study or control vaccine.|||Participants|||Number
1381426|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.|Day 30 after final booster vaccination|Geometric mean titers to vaccine antigens were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1381427|NCT01444781|Secondary|Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata|Anti-PT and anti-FHA antibodies were measured by ELISA.|Day 0 (pre-vaccination) and Day 30 after final booster vaccination|Booster responses to vaccine antigens were assessed in the Per Protocol Analysis Set.|||Participants|||Number
1381428|NCT01444781|Secondary|Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.|Day 30 after final booster vaccination|Geometric mean titers against Prevenar vaccine serotypes were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1381429|NCT01444781|Secondary|Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.|Day 30 after final booster vaccination|Antibody responses against Prevenar vaccine serotypes were assessed in the Per-protocol Analysis Set.|||Participants|||Number
1381440|NCT01444651|Secondary|Baseline to 3-month Change in Endothelial Function Measured by EndoPAT|Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)|Baseline and 3 months||||unitless index||Standard Deviation|Mean
1381430|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.|"Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker).~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Geometric mean titers against vaccine antibodies were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1381431|NCT01444781|Primary|Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.|||Participants|||Number
1381432|NCT01444781|Primary|Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.|||Participants|||Number
1381433|NCT01444781|Primary|Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per-protocol Analysis Set.|||Participants|||Number
1381434|NCT01444781|Primary|Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine|"Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers"|Day 140 (Primary series) and Day 0 (Pre-booster)|Antibody responses were assessed in the Per Protocol Analysis Set, which includes all persons who did not have any protocol deviations.|||Participants|||Number
1381435|NCT01444742|Secondary|Overall Survival (OS)|Overall survival defined as the time interval from study entry date to the date of death due to any cause, measured in days/months. Bayesian time-to-event model used to monitor overall survival.|5 years||||Months||Full Range|Median
1381436|NCT01444742|Primary|Number of Participants With Complete Response (CR)|Complete Response Criteria (CR must last for at least 4 weeks): Marrow: </= 5% myeloblasts with normal maturation of all cell lines; Persistent dysplasia noted; Blood: Hemoglobin (Hb) >/= 11 g/dL (untransfused, patient not on EPO); Neutrophils >/= 1x109/L (not on myeloid growth factor); Platelets >/= 100 * 109/L (not on thrombopoietic agent); No blasts. Bone marrow aspirate and/or biopsy at the end of course 1 (day 28 +/- 7 days). The method of Thall, Simon, and Estey used to monitor response.|4 weeks after first cycle|One of the eighty-one participants registered on the study were in evaluable for response.|||Participants|||Count of Participants
1381437|NCT01444651|Secondary|Baseline to 3-month Change in Matsuda Disposition Index|Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = [Matsuda sensitivity index * insulinogenic index]|Baseline and 3 months||||unitless index||Standard Deviation|Mean
1381438|NCT01444651|Secondary|Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index|The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin|Baseline and 3 months||||unitless index||Standard Deviation|Mean
1381439|NCT01444651|Secondary|Insulinogenic Index|The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = [fasting insulin - insulin at time 30 min] / [fasting glucose - glucose at time 30 min]|Baseline and 3 months||||unitless index||Standard Deviation|Mean
1382294|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1381441|NCT01444651|Secondary|Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index|The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT [fasting glucose*fasting insulin* (mean glucose from time 30, 60, 90, 120 min) * (mean insulin at time 30, 60, 90, and 120 min)]|Baseline and 3 months||||unitless index||Standard Deviation|Mean
1381442|NCT01444651|Primary|Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR|The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = [fasting glucose * fasting insulin]/405|Baseline and 3 months||||mg*microunits/dL*mL||Standard Deviation|Mean
1381443|NCT01444456|Secondary|Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time|The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).|From Baseline to Week 13|Primary analysis set|||percentage of participants|||Number
1381444|NCT01444456|Secondary|Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time|The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|From Baseline to Week 13|Primary analysis set|||percentage of participants|||Number
1381445|NCT01444456|Secondary|Time to First Increase in Hemoglobin|Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL|From Baseline until Week 9|Primary analysis set|||days||95% Confidence Interval|Median
1381446|NCT01444456|Secondary|Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points|The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline and Week 9|Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline|||units on a scale||Standard Deviation|Mean
1381447|NCT01444456|Secondary|Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline to Week 9|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1381448|NCT01444456|Primary|Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for “Not at all” to 4 for “Very much”. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue).|Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.|The Primary analysis set consists of enrolled participants who received at least 1 dose of darbepoetin alfa, have baseline assessments for each of Hemoglobin, FACT-F subscale and VAS, and analyzable post-baseline assessments for each of Hemoglobin, FACT-F subscale, and VAS at Week 9.|||percentage of participants||95% Confidence Interval|Number
1381459|NCT01444417|Secondary|Percentage of Participants Who Received Rescue Medication During the Treatment Period|Rescue medication is any medication (other than excluded medications) that is intended to increase platelet counts or prevent bleeding.|24 weeks|Efficacy analysis set|||percentage of participants||95% Confidence Interval|Number
1381460|NCT01444417|Secondary|Number of Weeks With Platelet Response|Number of weeks with platelet counts ≥ 50 x 10^9/L during week 2 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.|Week 2 to week 25|Efficacy analysis set|||weeks||Full Range|Median
1385436|NCT01402115|Primary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||ng/mL||Standard Deviation|Mean
1381449|NCT01444430|Secondary|Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation|Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.|||Participants|||Number
1381450|NCT01444430|Secondary|Percent of Nights With Awakening(s) Due to Asthma|Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.|||Percentage of nights||Standard Error|Least Squares Mean
1381451|NCT01444430|Secondary|Asthma Control Questionnaire (ACQ6)|"The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide.~The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions."|baseline, day 28, day 84, day 182|Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score.|||ACQ6 overall score change from baseline||Standard Error|Least Squares Mean
1381452|NCT01444430|Secondary|Mean Number of Puffs of Rescue Medication Per 24 Hours|Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.|||Inhalations/day||Standard Error|Least Squares Mean
1381453|NCT01444430|Secondary|Percent of Days With Activity Limitation Due to Asthma|Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms.|||Percentage of days||Standard Error|Least Squares Mean
1381454|NCT01444430|Secondary|Percent of Days With no Asthma Symptoms|Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.|||Percentage of days||Standard Error|Least Squares Mean
1381455|NCT01444430|Primary|Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation|Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.|||Participants|||Number
1381456|NCT01444430|Primary|Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)|Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 27 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug.|||Participants|||Number
1381457|NCT01444417|Secondary|Number of Participants With Adverse Events|"A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal,~life threatening (places the subject at immediate risk of death),~requires in-patient hospitalization or prolongation of existing hospitalization,~results in persistent or significant disability/incapacity,~congenital anomaly/birth defect, and/or~other significant medical hazard. Adverse events were graded for severity according to the CTCAE version 3.0 grading scale, where Grade 3 = moderate, Grade 4 = life-threatening and Grade 5 = fatal.~Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to study drug. This relationship was determined by a “yes” or “no” response to the question: “Is there a reasonable possibility that the event may have been caused by study drug?”"|From the first dose of study drug until 4 weeks after last dose; 28 weeks.|Safety analysis set (all participants who received at least one dose of study drug)|||participants|||Number
1381458|NCT01444417|Secondary|Total Number of Composite Bleeding Episodes|A composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.|Week 2 to week 25|Efficacy analysis set|||bleeding episodes||Standard Deviation|Mean
1381461|NCT01444417|Secondary|Percentage of Participants With an Overall Platelet Response|"Overall platelet response is defined as either a durable platelet response or transient platelet response.~Durable platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 6 or more times during week 18 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medication.~Transient platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 4 or more times during week 2 to week 25 measurements but without durable platelet response. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications."|Week 2 to week 25|Efficacy analysis set|||percentage of participants||95% Confidence Interval|Number
1381462|NCT01444417|Primary|Percentage of Participants With a Durable Platelet Response|A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10^9/L during the last 8 weeks of treatment (platelet counts obtained from week 18 to week 25). If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.|Week 18 to week 25|Efficacy analysis set (all randomized participants)|||percentage of participants||95% Confidence Interval|Number
1381463|NCT01444391|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post-procedure|"This outcome measure analysis includes evaluation only of ears with TDS-placed tube.~Two subjects (3 ears) were excluded due to missing follow-up data. An additional 3 subjects (4 ears) were excluded because no TDS tube was placed. Three of the 37 participants analyzed had one of two study ears excluded, due to no TDS in that ear."|||ears|Participants||Number
1381464|NCT01444391|Secondary|Procedure Tolerability|Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient’s score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.|Day 0 (day of procedure)|The analysis population includes subjects with successful tube placement using the Tube Delivery System (TDS) in one or both ears. Six subjects were excluded for whom one ear had a successful TDS placement and one ear did not.|||participants|||Number
1381465|NCT01444391|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)||||participants|||Number
1381466|NCT01444391|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)||||devices|Participants||Number
1381467|NCT01444391|Primary|Number of Subjects With Procedural, Serious and Device-related Adverse Events.|Adverse events which are procedural, serious, and device-related.|Procedure through 2 weeks post-procedure||||subjects|||Number
1381468|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381469|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381470|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|"Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.~There are no sub scales."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381471|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1382295|NCT01438307|Secondary|Overall Survival|Assessment will be made in subjects with Stage IV NSCLC who receive Cabazitaxel-SRP6258 after progressing with first line platinum-based chemotherapy.|28 months||||months||95% Confidence Interval|Median
1381473|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381474|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381475|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381476|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381477|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381478|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381479|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381480|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381481|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381482|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381483|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|"SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.~rm-Based Scores."|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381484|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381485|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381542|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381486|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381487|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381488|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381489|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381490|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381491|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381492|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381493|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381494|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381495|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381496|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381497|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381498|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381538|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381499|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381500|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1381501|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381502|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381503|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381504|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381505|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|At day 0 (on the day of index procedure)|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381506|NCT01444378|Secondary|In-Stent Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:~The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Post-Procedure (≥ 1 day)|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percent Diameter stenosis||Standard Deviation|Mean
1381507|NCT01444378|Secondary|In-Segment Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:~The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Post-Procedure (≥ 1 day)|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
1381508|NCT01444378|Secondary|In-Segment Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:~The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Pre-Procedure|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
1381509|NCT01444378|Secondary|Stent Occlusion|Stent occlusion was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs > 30 days post-index procedure.|> 30 Days Post Study Procedure|ITT population.|||percentage of participants|||Number
1381510|NCT01444378|Secondary|Sub-Acute Stent Thrombosis|Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.|> 24 Hours – 30 Days Post Study Procedure|ITT population.|||percentage of participants|||Number
1381511|NCT01444378|Secondary|Acute Stent Thrombosis|Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.|0 - 24 Hours Post Study Procedure|ITT population.|||percentage of participants|||Number
1381512|NCT01444378|Secondary|Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)|In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.|12 months|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
1381539|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|At day 0 (on the day of index procedure)|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381513|NCT01444378|Secondary|Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)|In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.|1 month|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
1381514|NCT01444378|Secondary|Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)|"In-Stent Restenosis:~Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography."|12 months|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
1381515|NCT01444378|Secondary|Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)|"In-Stent Restenosis:~Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography."|1 month|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
1381516|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||ratio||Standard Deviation|Mean
1381517|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||ratio||Standard Deviation|Mean
1381518|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||ratio||Standard Deviation|Mean
1381519|NCT01444378|Secondary|Stent Integrity by X-ray|"Xrays were performed to evaluate stent integrity and to determine the presence of any stent fractures.~Grade of fracture as follows:~0 - No stent fracture(s) identified~- Single strut fracture only~- Multiple strut fractures~- Stent fracture with alignment~- Fracture out of alignment (≥ 2 segments)~- Spiral Fracture"|12 months|ITT population.|||percentage of participants|||Number
1381520|NCT01444378|Secondary|Maximum Walking Distance||12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381521|NCT01444378|Secondary|Maximum Walking Distance||6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381522|NCT01444378|Secondary|Maximum Walking Distance||1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381523|NCT01444378|Secondary|Maximum Walking Distance||Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381524|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1381525|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1381540|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381541|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381526|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1381527|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1381528|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381529|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381530|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381531|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
1381532|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
1381533|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
1381534|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
1381535|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381536|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381537|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1400709|NCT01258049|Secondary|PCT 90 [MITT Population]|Time for parasite counts to fall by 90%|28 days after start of treatment||||hours||Standard Deviation|Mean
1381543|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381544|NCT01444378|Secondary|Death||At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
1381545|NCT01444378|Secondary|Death||At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
1381546|NCT01444378|Secondary|Death||At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
1381547|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
1381548|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
1381549|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
1381550|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
1381551|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
1381552|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
1381553|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:~Worsening Rutherford-Becker Clinical Category;~Change in ABI by >0.15 and ABI ≤0.8"|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
1381554|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:~Worsening Rutherford-Becker Clinical Category;~Change in ABI by >0.15 and ABI ≤0.8"|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
1381555|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:~Worsening Rutherford-Becker Clinical Category;~Change in ABI by >0.15 and ABI ≤0.8"|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
1381565|NCT01444378|Primary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 365 days|Intention-to-treat (ITT) population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381566|NCT01444378|Primary|Major Adverse Event (MAE)|"Primary safety endpoint is freedom from MAE which is defined as a composite of:~Death due to all causes~Index limb major amputation (at or above the ankle)~Clinically-driven target lesion revascularization (TLR)"|30 days||||percentage of participants|||Number
1381567|NCT01444300|Secondary|Change in Timed 25 Foot Walking Speed||Baseline to 12 weeks||||seconds||Standard Deviation|Mean
1381556|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
1381557|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
1381558|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
1381559|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|Pre-Procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
1381560|NCT01444378|Secondary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381561|NCT01444378|Secondary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1381562|NCT01444378|Secondary|Acute Success : Technical Success|Technical success: Device success plus attainment of final residual stenosis of < 30%|With in 2 days of index post procedure|ITT population, per lesion analysis|||percentage of target lesions|Target Lesions||Number
1381563|NCT01444378|Secondary|Acute Success : Clinical Success|Clinical success: Defined on a per patient basis, as the attainment of a final residual stenosis of < 30% by core laboratory assessment using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.|With in 2 days after index post procedure or at hospital discharge (before 1 month)|ITT population, per subject analysis|||percentage of participants|||Number
1381564|NCT01444378|Secondary|Acute Success : Device Success|Device success defined on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.|With in 2 days of index post procedure|ITT population, per device analysis.|||percentage of devices|Device||Number
1383233|NCT01430624|Primary|Alcohol Use Disorders Identification Test (AUDIT)|Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months|6 months|Includes only participants with full scale score information at 6 months|||units on a scale||Standard Deviation|Mean
1381568|NCT01444300|Secondary|Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores|The ABC is an 11-point scale and subjects are asked to indicate personal level of confidence in doing specific activities without losing balance or becoming unsteady on a scale from 0% to 100%. The ratings are added (possible range =0 -1600) and divide by 16 to get each subject's ABC score. A high ABC score indicates a high degree of confidence and a low ABC score indicates a low degree of confidence.|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
1381569|NCT01444300|Primary|Change in Automatic Postural Response (APR )Latency|Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of ~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects.|Baseline to 12 weeks||||milliseconds||Standard Deviation|Mean
1381570|NCT01444287|Secondary|Overall Comfort|Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).|after 8 hours||||units on a scale||Standard Error|Least Squares Mean
1381571|NCT01444287|Primary|Limbal Redness|Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.|Baseline, After 8 hours of treatment conditions||||units on a scale||Standard Error|Least Squares Mean
1381572|NCT01444287|Primary|Endothelial Blebs|Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).|baseline, after 20 minutes of treatment conditions||||percentage of bleb area||Standard Error|Mean
1381573|NCT01444287|Primary|Corneal Thickness|Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.|After 8 hours of contact lens wear|Subjects are those enrolled and randomized to a trial arm.|||Percent Change||Standard Error|Least Squares Mean
1381574|NCT01444092|Secondary|IMPACT 3|IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).|Baseline to 8 weeks|Safety analysis set|||Units on a scale||Standard Deviation|Mean
1381575|NCT01444092|Secondary|PCDAI|Paediatric Crohn’s Disease Activity Index. Range from 0 (best) to 100 (worst).|Baseline to 8 weeks|Full analysis set|||Units on a scale||Standard Deviation|Mean
1381576|NCT01444092|Primary|Adverse Event|Number of patients with at least one adverse event|12 weeks|Safety analysis set|||Patients|||Number
1381577|NCT01444027|Primary|Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0–10 response scale. Higher scores indicate better financial quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
1381578|NCT01444027|Primary|Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0–10 response scale. Higher scores indicate better emotional quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
1381579|NCT01444027|Primary|Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0–10 response scale. Higher scores indicate better social quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
1381580|NCT01444027|Primary|Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0–10 response scale. Higher scores indicate better physical quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
1381581|NCT01444027|Primary|Caregiver Anxiety: Change From Baseline to Post-Intervention Exit|Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
1381582|NCT01443923|Secondary|Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
1381583|NCT01443923|Secondary|Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment||End of Treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
1381584|NCT01443923|Secondary|Safety and Treatment Outcome Measures Stratified by ESA Use||6 months|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
1381585|NCT01443923|Secondary|Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects||Day 0, Day 7|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
1381586|NCT01443923|Primary|Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
1381587|NCT01443858|Secondary|Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 3 (Session P3) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 3 weeks of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"|||percentage change||Standard Error|Mean
1381588|NCT01443858|Secondary|Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 1 (Session P2) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 1 week of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"|||percentage change||Standard Error|Mean
1381589|NCT01443858|Secondary|Number of Participants Completing the Continuous 4 Week Abstinence From Smoking|Continuous 4 week abstinence from smoking (weeks 3-6 post quit date), based on self-reported abstinence confirmed by expired air CO ≤8ppm, will be compared between each meclizine group and placebo, using logistic regression analyses|weeks 3-6 post quit date||||participants||95% Confidence Interval|Number
1381590|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3|To evaluate the effects of meclizine as an augmentation treatment in conjunction with nicotine patch, the percent decrease in expired air carbon monoxide (CO) at the end of week 3 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 3 weeks of treatment (relative to baseline)||||percentage change||Standard Error|Mean
1381591|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1|To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 1 week of treatment (relative to baseline)||||percentage change||Standard Error|Mean
1381592|NCT01443845|Secondary|Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)|Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)|Week 0 (Visit 2) to Week 52|Intent-to-Treat Population who the completed 52-week treatment period|||Liters||Standard Error|Least Squares Mean
1381593|NCT01443845|Secondary|Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics|Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.|Week 0 (Visit 2) to Week 52||||COPD Exacerbations per Patient per Year||95% Confidence Interval|Number
1381594|NCT01443845|Secondary|Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)|Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Week 0 (Visit 2) to Week 52|Intent-to-Treat Study Population|||COPD exacerbations per patient per year||95% Confidence Interval|Number
1381595|NCT01443845|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.|Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Baseline to Week 52|Intent-to-Treat Study Population|||COPD exacerbations per patient per year||95% Confidence Interval|Number
1381596|NCT01443494|Secondary|Perfused Vessel Density|Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density|Target MAP stabilization for 30 min||||vessels/mm^2||Standard Deviation|Mean
1381597|NCT01443494|Primary|Mean Arterial Pressure|"As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients’ physical examination records of the last two years was registered and assumed as patients’ usual level of MAP and target MAP. If patients’ medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.~After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements."|Target MAP stabilization for 30 min||||mmHg||Standard Deviation|Mean
1381598|NCT01443403|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|"Treatment-emergent adverse events (TEAEs) were adverse events that occurred after the first dose of study drug.~Treatment-related TEAEs were defined as TEAEs that were considered by the Investigator to be definitely, probably, or possibly related to study drug."|From first dose of study drug through 28 days after the last dose of study treatment (up to 57 days).|Adverse events were assessed using the safety population. The safety population included all participants who received study drug. This population was analyzed as treated.|||participants|||Number
1381847|NCT01441765|Secondary|Effect on Circulating Regulatory T Cells|To evaluate the effect of CT-011 alone or in conjunction with DC/RCC fusions on circulating regulatory T cells and PD-1 expression by circulating and bone marrow derived T cells.|2 years|Data was not analyzed as so few participants were enrolled and no participants achieved a PR.||||||
1381599|NCT01443403|Secondary|Area Under the Concentration-time Curve From Hour 0 to the Time Point of the Last Measurable Concentration Within the Dose Interval (AUC0-τ)|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose|PK population with available data|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1381600|NCT01443403|Secondary|Time to Maximum Concentration (Tmax) of Naldemedine and Metabolite Nor-S-297995|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose|PK population with available data|||hours||Full Range|Median
1381601|NCT01443403|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2, 4, 8, and 24 hours postdose|The PK parameter population (PK population) includes all participants who received study drug with at least one PK parameter estimated adequately on Day 1 or Day 28|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1381602|NCT01443403|Secondary|Subject Global Satisfaction at End of Treatment|On day 29 (or at early termination), participants were asked about their degree of satisfaction with constipation and abdominal symptoms from the start of study drug dosing to Day 28 (or early termination visit). The grades were as follows: 1, markedly worsened; 2, moderately worsened; 3, slightly worsened; 4, unchanged; 5, slightly improved; 6, moderately improved; and 7, markedly improved.|Day 29, or at early termination|mITT population|||participants|||Number
1381603|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Discomfort|Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and Weeks 1, 2, 3, and 4|mITT population with a value at both baseline and the specified time point.|||units on a scale||Standard Deviation|Mean
1381604|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Discomfort|Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with a value at both baseline and the last 2 weeks of treatment.|||units on a scale||Standard Deviation|Mean
1381605|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Bloating|Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and Weeks 1, 2, 3, and 4|mITT population with a value at both baseline and the specified time point.|||units on a scale||Standard Deviation|Mean
1381606|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Bloating|Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with a value at both baseline and the last 2 weeks of treatment.|||units on a scale||Standard Deviation|Mean
1381607|NCT01443403|Secondary|Mean Rescue Laxative Use Per Week During the Treatment Period|Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).|Weeks 1 to 4|mITT population|||doses/week||Standard Deviation|Mean
1381608|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Rescue Use of Laxative Agents Per Week|Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||doses/week||Standard Deviation|Mean
1381609|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of False Start BMs Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted)."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with values at both baseline and the last 2 weeks of the treatment period|||false start BMs||Standard Deviation|Mean
1381610|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of SBMs Per Week Without Straining|Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining is defined as a BM with a straining score of 0 or 1.|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||bowel movements/week||Standard Error|Least Squares Mean
1381611|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week With no Straining|Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score of 0 or 1.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||bowel movements/week||Standard Error|Least Squares Mean
1381612|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Number of SBMs Rated as 3 or 4 on the Bristol Stool Scale Per Week|Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||spontaneous bowel movements/week||Standard Error|Least Squares Mean
1385437|NCT01402115|Primary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
1381613|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week Rated as 3 or 4 on the Bristol Stool Scale|Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||spontaneous bowel movements/week||Standard Error|Least Squares Mean
1381614|NCT01443403|Secondary|Percentage of Participants With CSBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug|The percentage of participants who experienced at least one CSBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.|4, 8, 12, and 24 hours|mITT population|||percentage of participants|||Number
1381615|NCT01443403|Secondary|Percentage of Participants With SBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug|The percentage of participants who experienced at least one SBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.|4, 8, 12, and 24 hours|mITT population|||percentage of participants|||Number
1381616|NCT01443403|Secondary|Time to the First Complete Spontaneous Bowel Movement|Time to the first CSBM was defined as the time to the first CSBM after the initial administration of study drug. Participants who withdrew from the study before a CSBM was observed or had no CSBM during the treatment period were treated as censored.|28 days|mITT population|||hours||95% Confidence Interval|Median
1381617|NCT01443403|Secondary|Time to the First Spontaneous Bowel Movement|Time to the first SBM was defined as the time to the first SBM after the initial administration of study drug. Participants who withdrew from the study before an SBM was observed or had no SBM during the treatment period were treated as censored.|28 days|mITT population|||hours||95% Confidence Interval|Median
1381618|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With CSBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||days/week||Standard Error|Least Squares Mean
1381619|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With CSBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||days/week||Standard Error|Least Squares Mean
1381620|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With SBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||days/week||Standard Error|Least Squares Mean
1381621|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With SBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||days/week||Standard Error|Least Squares Mean
1381622|NCT01443403|Secondary|Percentage of Participants With a CSBM Response at Weeks 1, 2, 3, and 4|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM responder was defined as a participant whose frequency of CSBMs during the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week."|Baseline and Weeks 1, 2, 3, and 4|mITT population; missing data were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
1381623|NCT01443403|Secondary|Percentage of Participants With a CSBM Response in the Last 2 Weeks of the Treatment Period|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM responder was defined as a participant whose frequency of CSBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||percentage of participants|||Number
1381624|NCT01443403|Secondary|Percentage of Participants With an SBM Response at Weeks 1, 2, 3 and 4|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM responder was defined as any participant whose frequency of SBM per week during the treatment period was 3 times or more per week, and who had an average increase from baseline of 1 or more per week."|Baseline and Weeks 1, 2, 3, and 4|mITT population; missing data were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
1381625|NCT01443403|Secondary|Percentage of Participants With an SBM Response in the Last 2 Weeks of the Treatment Period|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM responder was defined as a participant whose frequency of SBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of SBMs from baseline of 1 or more per week."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||percentage of participants|||Number
1381899|NCT01441245|Primary|Evaluation of Renal Function in Terms of Creatinine Levels at Discharge||from admission to discharge, an average of 12 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|||mg/dL||Standard Deviation|Mean
1381626|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||complete spontaneous BMs per week||Standard Error|Least Squares Mean
1381627|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||complete spontaneous BMs per week||Standard Error|Least Squares Mean
1381628|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A complete BM (CBM) was defined as a BM where the participant answered ‘Yes’ to the following question: ‘Did you have a feeling of complete emptying after the bowel movement?’"|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||complete bowel movements per week||Standard Error|Least Squares Mean
1381629|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Bowel Movements (CBMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A complete BM (CBM) was defined as a BM where the participant answered ‘Yes’ to the following question: ‘Did you have a feeling of complete emptying after the bowel movement?’"|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||complete bowel movements per week||Standard Error|Least Squares Mean
1381630|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A BM was defined as all bowel movements observed irrespective of the use of a laxative agent."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||bowel movements per week||Standard Error|Least Squares Mean
1381631|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Bowel Movements (BMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A BM was defined as all bowel movements observed irrespective of the use of a laxative agent."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||bowel movements per week||Standard Error|Least Squares Mean
1381632|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to randomization."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||spontaneous bowel movements per week||Standard Error|Least Squares Mean
1381633|NCT01443403|Primary|Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the average number of SBMs per week recorded in the diary for the 14 days prior to the last dose of study drug."|Baseline (2 weeks prior to randomization) and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|Modified intention-to-treat population|||spontaneous bowel movements per week||Standard Error|Least Squares Mean
1381634|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381635|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381636|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381900|NCT01441245|Secondary|Length of Hospitalization in the Two Groups|percentage of participants with hospital stay > 10 days|in-hospital|Qualitative variables are expressed as percentage and compared with chi-square test . p values <0.05 were considered significant.|||percentage of partecipants|||Number
1381637|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381638|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381639|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381640|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381641|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381642|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381643|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381644|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381645|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381646|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 2||||units on a scale||Full Range|Median
1381647|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381648|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381649|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381650|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381651|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381652|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381653|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381654|NCT01443364|Secondary|Bone Erosion at Week 0|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381655|NCT01443364|Secondary|Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381656|NCT01443364|Secondary|Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381657|NCT01443364|Secondary|Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381658|NCT01443364|Secondary|Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381659|NCT01443364|Secondary|Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381660|NCT01443364|Secondary|Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381661|NCT01443364|Secondary|Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1385438|NCT01402102|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||µEq/L||Standard Deviation|Mean
1381662|NCT01443364|Secondary|Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381663|NCT01443364|Secondary|Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381664|NCT01443364|Secondary|Cartilage Damage at Week 0|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381665|NCT01443364|Secondary|Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381666|NCT01443364|Secondary|Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381667|NCT01443364|Secondary|Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381668|NCT01443364|Secondary|Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381669|NCT01443364|Secondary|Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381670|NCT01443364|Secondary|Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381671|NCT01443364|Secondary|Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381672|NCT01443364|Secondary|Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381673|NCT01443364|Secondary|Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381674|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 0|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381675|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381676|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381677|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381678|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381679|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381680|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381681|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381682|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381683|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381684|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 0|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381685|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381686|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381687|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381688|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1382038|NCT01440101|Secondary|Part A: Summary of Lymphocyte Counts Over Time||Baseline [Week 0]); 28 days post-dose; Weeks 12, 24, and 32 (follow-up)|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of lymphocytes; n=participants with assessment at timepoint.|||cells/microliter||Standard Deviation|Mean
1381689|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381690|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381691|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381692|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381693|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381694|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381695|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381696|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381697|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381698|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381699|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381700|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381701|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381702|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381703|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381704|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381705|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381706|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381707|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381708|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381709|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381710|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381711|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381712|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381713|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381714|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381715|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381716|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381717|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381718|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381719|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381720|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381721|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381722|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381723|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381724|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1383104|NCT01431716|Other Pre-specified|Number of Participants With Adverse Events Leading to Discontinuation of Study Drug From Baseline to EOT.|Adverse events that led to discontinuation of study drug from the start of study treatment until the end of study treatment were recorded.|Approximately 3 months|All-treated set.|||participants|||Number
1381725|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381726|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381727|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381728|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381729|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381730|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381731|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381732|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381733|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381734|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381735|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381736|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381737|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381738|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381739|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381740|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381741|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381742|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381743|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381744|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381745|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381746|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381747|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
1381748|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 1 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
1381749|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 2 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
1383234|NCT01430624|Primary|Drug Abuse Screening Test (DAST-10)|total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months|6 months|Only includes participants with complete scale data at 6 months|||units on a scale||Standard Deviation|Mean
1381750|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 4 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
1381751|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 6 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
1381752|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 8 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
1381753|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 12 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
1381754|NCT01443130|Secondary|Incidence of Infection in the Fetal Circulation|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants with cord blood smears and cord PCR results obtained.|||percentage of participants||97.5% Confidence Interval|Number
1381755|NCT01443130|Secondary|Incidence of Clinical Malaria, All Species|Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.|||percentage of participants||97.5% Confidence Interval|Number
1381756|NCT01443130|Secondary|Incidence of Malaria Infection, All Species.|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.|||percentage of participants||97.5% Confidence Interval|Number
1381757|NCT01443130|Secondary|Incidence of Active Placental Malaria Infection|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR).|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all maternal subjects with placental slides reviewed and PCR results obtained.|||percentage of participants||97.5% Confidence Interval|Number
1381758|NCT01443130|Secondary|Incidence of Intrauterine Growth Restriction (IUGR)|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar.|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery.|||percentage of participants||97.5% Confidence Interval|Number
1381759|NCT01443130|Secondary|Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all infants born alive with weight data collected at birth.|||percentage of infants||97.5% Confidence Interval|Number
1381760|NCT01443130|Secondary|Infant Mortality Rate to 14 Weeks of Age|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery.|For 14 weeks after delivery.|The analysis population includes all enrolled infants.|||percentage of infants||97.5% Confidence Interval|Number
1381761|NCT01443130|Secondary|Incidence of Preterm Delivery|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.|||percentage of deliveries||97.5% Confidence Interval|Number
1381762|NCT01443130|Secondary|Incidence of Miscarriage|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants.|||percentage of pregnancies||97.5% Confidence Interval|Number
1381763|NCT01443130|Secondary|Incidence of Stillbirth|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.|||percentage of deliveries||97.5% Confidence Interval|Number
1381764|NCT01443130|Secondary|Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl.|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.|||percentage of maternal participants||97.5% Confidence Interval|Number
1381765|NCT01443130|Secondary|Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL).|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.|||percentage of maternal participants||97.5% Confidence Interval|Number
1381766|NCT01443130|Secondary|Incidence of Placental Malaria by Placental Impression Smear|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed.|||percentage of placentas||97.5% Confidence Interval|Number
1381767|NCT01443130|Primary|Incidence of Placental Malaria Infection Based on Histology|The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue.|At delivery: Approximately 12-36 weeks after enrollment|All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis.|||percentage of pregnancies||97.5% Confidence Interval|Number
1381768|NCT01443078|Secondary|Pathologic Response Rate|The percentage of patients with a major pathologic response|2 years||||percentage of patients||95% Confidence Interval|Number
1381769|NCT01443078|Primary|PERCIST Partial Metabolic Response|"The primary endpoint was partial metabolic response after 2 cycles of switch therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline)."|2 years||||participants|||Number
1381770|NCT01443026|Primary|Changes in Serum Biomarkers|Change in serum lycopene, umol/L|baseline and 6 months||||umol/L||Full Range|Mean
1381771|NCT01443026|Secondary|Changes in Nuclear Morphometry|We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.|baseline and 6 months|||||||
1381772|NCT01443026|Primary|Tissue Biomarkers|We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.|baseline and 6 months|||||||
1381773|NCT01442844|Primary|Percentage of Wound Re-epithelialization||4 weeks||||percentage of wound re-epithelialization||Full Range|Mean
1381774|NCT01442779|Secondary|Participants With Change in Cough|changes in cough status after treatment for 1 month.|1 month|During the course of the study it was noted that subjects experienced a change in the cough that is sometimes associated with IPF. The 6 subjects still enrolled in the study were asked to complete a questionnare regarding the status of the cough.|||Participants|||Number
1381775|NCT01442779|Primary|Minimal/no Change in Quality of Life||12 months|Analysis was performed only on those subject who continue on medication for at least one year.|||Participants|||Number
1381776|NCT01442779|Primary|Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function|Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects.|1 yr||||Participants|||Number
1381777|NCT01442714|Secondary|Overall Survival|Survival was measured from the 1st day of azacitidine treatment to death from any cause.|462 Days||||months||95% Confidence Interval|Median
1381778|NCT01442714|Secondary|Median Duration of Response|The median duration of response was defined by the median duration of response for participants with Complete Response (CR); CR with incomplete count recovery (CRi); or Partial Response (PR).|203 days||||days||95% Confidence Interval|Median
1381779|NCT01442714|Primary|Overall Response Rate (ORR)|Overall response rate was defined as the sum of Complete Response (CR) + CR with incomplete count recovery (CRi) + Partial Response (PR).|203 days||||Participants|||Count of Participants
1381780|NCT01442688|Primary|Maximum Plasma Concentration (Cmax) for Amoxicillin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set|||ug/ml||Standard Deviation|Mean
1381781|NCT01442688|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|The Pharmacokinetic Analysis Set was defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||h*ug/ml||Standard Deviation|Mean
1381848|NCT01441765|Secondary|Immunologic Response|To evaluate immunologic response directed against RCC and tumor specific antigens following therapy with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Immunologic response will be characterized as peak response post-therapy and ongoing response at 3 and 6 months following treatment.|2 years|Data was not analyzed as so few participants were enrolled and none of the participants achieved a PR or CR.||||||
1381782|NCT01442675|Secondary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1381783|NCT01442675|Secondary|Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point.|||Titers ratio||95% Confidence Interval|Geometric Mean
1381784|NCT01442675|Secondary|Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point.|||Titers||95% Confidence Interval|Geometric Mean
1381785|NCT01442675|Secondary|Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|||Participants|||Number
1381786|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).~Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|||Participants|||Number
1381787|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).~Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|||Participants|||Number
1381788|NCT01442675|Primary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)|Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set.|||Participants|||Number
1381789|NCT01442493|Secondary|Number of Participants Meeting DSM-IV Cocaine Dependence Criteria|Number of participants meeting DSM-IV cocaine dependence criteria|12-months post-baseline|Baseline values were used when 12 month data were missing|||Participants|||Count of Participants
1381790|NCT01442493|Secondary|Number of Participants Meeting DSM-IV Opiate Dependence Criteria|Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence|12-months post-baseline|Baseline values were used when 12 month data were missing|||Participants|||Count of Participants
1381791|NCT01442493|Secondary|Global Score on the World Health Organization Quality of Life Measure|Scale from 1 through 5. A higher score reflects a better quality of life.|12-months post-baseline|Baseline values were used when 12 month data were missing|||units on a scale||Standard Deviation|Mean
1381792|NCT01442493|Secondary|Criminal Behavior|Days of criminal behavior|12-months post-baseline||||Number of Days in the Past 30 days||Standard Deviation|Mean
1381793|NCT01442493|Secondary|Drug Use HIV Risk Behavior|HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|12-months post-baseline|Baseline values were used when 12 month data were missing.|||units on a scale||Standard Deviation|Mean
1381794|NCT01442493|Secondary|Number of Participants With Cocaine Positive Urine Tests|Cocaine positive urine drug test|12-months post-baseline|Missing data were considered positive|||Participants|||Count of Participants
1381795|NCT01442493|Primary|Number of Participants With Opiate Positive Urine Tests|Number of participants with opiate positive urine tests|12-months post-baseline|Missing data were counted as positive|||Participants|||Count of Participants
1381896|NCT01441245|Primary|Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge||participants were followed for the duration of hospital stay, an average of 13 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|||pg/mL||Standard Deviation|Mean
1381796|NCT01442376|Secondary|Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from >24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle.|from >24 to 120 hours (delayed phase) after T0|Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
1381797|NCT01442376|Primary|Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy.|0 to 24 hours after T0|Full Analysis Set (FAS) population|||percentage of patients||95% Confidence Interval|Number
1381798|NCT01442181|Other Pre-specified|Directed Fluency, Animals|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many animals as possible beginning with a letter, for one minute.|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||animals||Standard Deviation|Mean
1381799|NCT01442181|Other Pre-specified|Stroop Word Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop word test, and only 6 patients in the medical therapy group completed the stroop word test.~In this test, subjects are asked to read a list of words. 100 is the maximum amount of correct responses per trial."|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
1381800|NCT01442181|Other Pre-specified|Wtar (Wechsler Test of Adult Reading) Word List|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).~The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete. The examiner begins by presenting the first word card and prompting the patient for a single pronunciation of the word. This procedure continues through all 50 word cards and is discontinued if the patient provides 12 consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, with 50 as the maximum raw score."|Baseline|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
1381801|NCT01442181|Other Pre-specified|Stroop Color Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop color test, and only 6 patients in the medical therapy group completed the stroop color test.~In this test, subjects are asked to read a list of color words. 100 is the maximum amount of correct responses per trial."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||colors||Standard Deviation|Mean
1381802|NCT01442181|Other Pre-specified|Hopkins Verbal Learning Test Version A|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). This test measures word recognition. 12 words are read to the subject and they have to repeat as many as they can recall. There are 4 trials, each with 12 total possible words.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
1381803|NCT01442181|Other Pre-specified|Directed Fluency; Cowa (Controlled Oral Word Association Test)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many words as possible beginning with a letter, excluding proper nouns, for one minute and this procedure is repeated three times.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
1381804|NCT01442181|Other Pre-specified|Montreal Cognitive Assessment (Moca)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The score is 0 - 30 point test with the higher the score the better cognitive function.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
1381805|NCT01442181|Other Pre-specified|STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
1381897|NCT01441245|Primary|Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment||from admission to discharge, an average of 12 days||||pg/ml||Standard Deviation|Mean
1383537|NCT01426438|Secondary|Women: Change in HDL Cholesterol|Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Women in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
1381806|NCT01442181|Other Pre-specified|STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
1381807|NCT01442181|Primary|Quality of Life RAND 36-Item Health Survey|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).~The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores which will have a 0 to 100 range."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
1381808|NCT01442155|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 3 years|Safety population included all participants treated with at least one dose of study drug.|||percentage of participants|||Number
1381809|NCT01442155|Primary|Disease-Free Survival (Time to Event)|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).|Up to 3 years|Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy.|||months||95% Confidence Interval|Median
1381810|NCT01442129|Secondary|Functional Status and Ventricular Function|"The key efficacy endpoint of this study is functional status and ventricular function, while weaned from LVAD support, at 90 days post intervention (LVAD implantation + intramyocardial injection of study product). Functional status is defined by the ability to tolerate wean from LVAD support for 30 minutes without signs or symptoms of hypoperfusion, including, but not limited to symptoms of low output or signs of vascular congestion. Ventricular function will be assessed by transthoracic echocardiogram (TTE) in those patients able to be weaned for 30 minutes from LVAD support.~The number of participants who successfully tolerated the 30 minute wean from LVAD support at 90 days is reported."|90 days||||participants|||Number
1381811|NCT01442129|Primary|Intervention Related Adverse Events|The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.|90 days||||events|||Number
1381812|NCT01442103|Secondary|Pain Upon Application of Investigational Product.|VAS pain scale will be used to measuring pain at each dressing change.|4 weeks|||||||
1381813|NCT01442103|Secondary|Infection Assessment|Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.|4 weekks|||||||
1381814|NCT01442103|Primary|Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.|Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.|4 weeks|Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit.|||participants|||Number
1381815|NCT01442064|Secondary|Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)|"NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24.~Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836)."|Baseline (Day 0 of extension study), Months 12 and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||Scores on a scale||Standard Deviation|Mean
1381816|NCT01442064|Secondary|Change From Baseline in Central Foveal Thickness at Month 6 and Month 12|Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.|Baseline (Day 0 of extension study), Months 6 and 12|"Enrolled participants for whom data was available for analyses at the given time-point as indicated by n in the categories. Observed data were used with no imputation."|||µm||Standard Deviation|Mean
1381817|NCT01442064|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA)|Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.|Baseline (Day 0 of extension study), Months 6, 12, 18, and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||letters||Standard Deviation|Mean
1381818|NCT01442064|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.~Additional information about adverse events can be found in the adverse events section."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.|||participants|||Number
1381819|NCT01442064|Primary|Number of Participants With Ocular Adverse Events in the Study Eye|"Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.|||participants|||Number
1381820|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set|||percentage of participants|||Number
1381821|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set|||percentage of participants|||Number
1381822|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set|||percentage of participants|||Number
1381823|NCT01442038|Primary|Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization|Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set: all participants in the Safety Analysis Set (randomized and received at least one dose of study drug), except participants with no qualifying percutaneous coronary intervention (PCI; formerly known as angioplasty with stent))|||percentage of participants|||Number
1381824|NCT01441973|Secondary|Objective Response Rate (ORR)|ORR is defined as the number of participants with stringent compete response [SCR], complete response [CR], very good partial response [VGPR], and partial response [PR])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level <100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to <200 mg/24 hour|From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)|All treated participants|||Percentage of participants||90% Confidence Interval|Number
1381825|NCT01441973|Secondary|Progression Free Survival (PFS) Rate|The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort|Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)|All treated participants|||Probability of Progression Free Survival||90% Confidence Interval|Number
1381826|NCT01441973|Secondary|Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate|All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.|cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months|All participants who received at least 1 dose of study drug|||Participants|||Number
1381827|NCT01441973|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality|Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.|From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months|All participants who received at least 1 dose of study drug|||Participants|||Number
1381828|NCT01441973|Primary|Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow|Estimated using linear regression model, with baseline CD56^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56^dim cells (% chg from BL in M pro/% chg CD56^dim cs)|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).|||% chg from BL in M pro/% chg CD56^dim cs||95% Confidence Interval|Number
1381898|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in Creatinine Levels|evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.|participants were followed for the duration of hospital stay, an average of 13 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|||mg/dL||Standard Deviation|Mean
1381829|NCT01441973|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug|||Participants|||Number
1381830|NCT01441960|Secondary|Differences in Seizure Duration Between Compounds|Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.|Up to six weeks following inclusion||||Seconds||Standard Deviation|Mean
1381831|NCT01441960|Secondary|Compound Specific Differences in Time to Recovery From Neuromuscular Blockade|The investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.|Up to six weeks following inclusion||||minutes||Standard Deviation|Mean
1381832|NCT01441960|Primary|Optimal Dose of Neuromuscular Blocking Agent During ECT|The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.|Up to six weeks following inclusion||||mg.kg-1||95% Confidence Interval|Mean
1381833|NCT01441882|Other Pre-specified|Biomarker Analysis of SRC, TEC, or BTK Family Kinase Inhibition|Use of either t-test (normally distributed variables) or Wilcoxon rank sum test (non-normally distributed variables) to determine whether the mean of continuous biomarkers or patient factors (e.g., IC50 dasatinib cytotoxicity, SRC family kinase inhibition level, TEC family kinase inhibition level, disease risk such as the presence or absence of poor risk features as defined in the protocol) are significantly different between responders and non-responders.|Up to 2 years|||||||
1381834|NCT01441882|Secondary|Target Response Rate|Proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.|Up to 2 years|||||||
1381835|NCT01441882|Secondary|Progression-free Survival|Kaplan-Meier method will be used to estimate the survival curve.|Up to 2 years|||||||
1381836|NCT01441882|Secondary|Overall Survival|Kaplan-Meier method will be used to estimate the survival curve.|Up to 2 years|||||||
1381837|NCT01441882|Secondary|Objective Response|Proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.|Up to 2 years|||||||
1381838|NCT01441882|Secondary|Incidence of Adverse Events Assessed According to the NCI Common Terminology Criteria for Adverse Events Version 4.0|Adverse events will be tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).|Up to 2 years||2019-07-31|07/2019||||
1381839|NCT01441882|Primary|In Vitro Dasatinib Sensitivity in Predicting Clinical Activity|Defined by a decrease in absolute lymphocyte count, as determined by peripheral blood complete blood count (CBC) with differential or by bone marrow examination of 50 % and/or a decrease of detectable total lymph node size or spleen size by 50% (either by clinical examination contrast enhanced computed tomography [CT]). Summarized using descriptive statistics (e.g., proportions for categorical variables, and mean/standard deviation for continuous variables).|8 weeks|Five patients met the primary objective. Four patients had a decrease in absolute lymphocyte count (peripheral blood complete blood count (CBC) with differential or by bone marrow examination of 50%), 4 patients had a decrease of detectable total lymph node size by 50%, and no patients had a decrease in spleen size by 50%.|||Participants|||Count of Participants
1381840|NCT01441843|Secondary|Somatic Symptoms and Complaints|Medical records are used to assess somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure somatic symptoms and complaints.|Baseline; first postoperative working day; 1 week after surgery|||||||
1381841|NCT01441843|Secondary|Depressive Mood|The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of depression.|baseline; 1 week after surgery|||||||
1381842|NCT01441843|Secondary|Aggression Regulation|The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of aggression|baseline; 1 week after surgery|||||||
1381843|NCT01441843|Secondary|Fatigue|The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of fatigue.|baseline; 1 week after surgery|||||||
1381844|NCT01441843|Secondary|Anxiety|The State-Trait Anxiety Inventory (STAI) is used to assess anxiety. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of anxiety.|baseline; after surgery but before discharge; 1 week after surgery|||||||
1381845|NCT01441843|Primary|Quality of Recovery Score|"The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery.~Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery."|Baseline; first postoperative working day; seventh postoperative day.||||scores on a scale||Standard Deviation|Mean
1381846|NCT01441765|Secondary|Number of Participants Who Survived at 2 Years|To evaluate overall survival following treatment with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.|2 years||||participants|||Number
1383538|NCT01426438|Secondary|Men: Change in HDL Cholesterol|Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Men in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
1381849|NCT01441765|Primary|Number of Participants With PR or CR at 2 Years|"To evaluate the complete and partial response rate following completing 4 cycles of CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, (with an absolute increase of at least 5 mm), or the appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|2 years||||participants|||Number
1381850|NCT01441765|Primary|Number of Participants With Adverse Events|Assessment of toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction with DC/RCC. Toxicity was assessed and classified according to CTCAE Version 4.0.|2 years||||participants|||Number
1381851|NCT01441596|Secondary|Overall Survival|Overall Survival is defined as time from randomisation to the date of death from any cause.|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who died|||weeks||Inter-Quartile Range|Median
1381852|NCT01441596|Secondary|Progression-Free Survival|"Progression-Free Survival is defined as the time from the date of randomisation to the date of disease progression or death whichever came first.~Disease progression was defined as either disease progression in CNS lesions (including worsening in NSS and use of corticosteroid) or disease progression in extra-CNS lesions according to RECIST 1.1."|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who experienced disease progression or death|||weeks||Inter-Quartile Range|Median
1381853|NCT01441596|Primary|Patient Benefit Rate at 12 Weeks|Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1|12 weeks from randomisation|Randomised Set (RS): includes all randomised patients, whether treated or not.|||percentage of participants||95% Confidence Interval|Number
1381854|NCT01441570|Secondary|Blood Pressure|Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.|12 weeks||||mmHg||Standard Deviation|Mean
1381855|NCT01441570|Primary|Quality of Life|"Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires. The four quality of life questionnaires that were used included the following:~Short Form (SF)-36v2 Health Survey (Score Range = 0-100; the lower the score the more disability)~Sexual Dysfunction Tool for Men = International Index of Erectile Function (IIEF) Questionnaire (Score Range = 5-25; a score of 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction)~Sexual Dysfunction Tool for Women = Changes in Sexual Functioning Questionnaire (CSFQ-14-F; Score Range = 14-70; a score at or below 42 is indicative of sexual dysfunction)~Multidimensional Assessment of Fatigue (MAF) Scale (Score Range = 1-50; the higher the score the more fatigue)"|12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 – End of week 12)|Adult (>18 years of age) renal transplant recipients, both men and women, requiring pharmacotherapy for high blood pressure were evaluated for inclusion in this analysis.|||units on a scale||Standard Deviation|Mean
1381856|NCT01441466|Secondary|Cross-infection|nosocomially acquired cross-infection|measured until 1 week after hospital exit||||participants|||Number
1381857|NCT01441466|Secondary|Mechanical Ventilation|Mechanical ventilation and endotracheal intubation needed|duration of hospitalisation, an average of 3-4 days||||participants|||Number
1381858|NCT01441466|Secondary|Highest Dyspnoea Score|highest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)|duration of hospitalisation, an average of 3-4 days||||units on a scale (0-10)||Standard Deviation|Mean
1381859|NCT01441466|Secondary|Supplemental Oxygen Needed|number of days that supplemental oxygen was needed|duration of hospitalisation, an average of 3-4 days||||days||Standard Deviation|Mean
1381860|NCT01441466|Secondary|Number of Days With Tube Feeding|number of days the patient has been tube fed|duration of hospitalisation, an average of 3-4 days||||days||Standard Deviation|Mean
1381861|NCT01441466|Primary|Duration of Hospital Stay||duration of hospitalisation, an average of 3-4 days||||days||Standard Deviation|Mean
1381862|NCT01441440|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
1381863|NCT01441440|Secondary|Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
1381864|NCT01441440|Secondary|Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination|HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
1381865|NCT01441440|Secondary|Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
1381866|NCT01441440|Secondary|Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination|MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 – 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
1381867|NCT01441440|Primary|Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
1381868|NCT01441414|Secondary|Overall Survival (OS) at 2 Years|OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS.|5 years|This endpoint was not assessed due to the early termination of the study.||||||
1381869|NCT01441414|Secondary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date – the date of randomization +1).|3 years|This endpoint of estimating median PFS was not assessed due to early termination of the study.||||||
1381870|NCT01441414|Secondary|Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive|Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.|0 and 360 hours post dose and end of study|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||ADA samples|Participants||Number
1381871|NCT01441414|Secondary|Cmin (Trough PF-04856884 Serum Concentration)|Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||ng/mL||Standard Deviation|Mean
1381872|NCT01441414|Secondary|Cmax (Observed Peak Serum PF-04856884 Concentration)|Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||ng/mL||Standard Deviation|Mean
1381873|NCT01441414|Secondary|Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)|Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||hr||Standard Deviation|Mean
1381874|NCT01441414|Secondary|Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone|DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR − first CR or PR that is subsequently confirmed +1).|3 years|This endpoint was not assessed due to the early termination of the study.||||||
1383539|NCT01426438|Secondary|Change in Triglycerides|Change in Triglycerides (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
1381875|NCT01441414|Secondary|Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.|ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||Percentage of participants|||Number
1381876|NCT01441414|Secondary|Number of Participants With Non-serious AEs and SAEs|Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).|3 years|This endpoint was not assessed due to the early termination of the study.||||||
1381877|NCT01441414|Primary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date – the date of randomization +1).|3 years|The primary efficacy endpoint of estimating median PFS in Part II was not assessed due to early termination of the study.||||||
1381878|NCT01441414|Primary|Number of Participants With Serious Adverse Events (SAEs) in Part I|Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||participants|||Number
1381879|NCT01441414|Primary|Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).|"Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below.~Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week)."|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||participants|||Number
1381880|NCT01441401|Other Pre-specified|Reduction From Baseline in Epileptic Seizure Frequency|Reduction from baseline in epileptic seizure frequency was defined by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: Reduction from baseline in epileptic seizure frequency (%) = [(T-B) / B] X 100. The median percentages were presented along with the corresponding minimum and maximum percentages.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.|||Percentage||Full Range|Median
1381881|NCT01441401|Other Pre-specified|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was – 0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of – 0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.|||Percentage of participants||95% Confidence Interval|Number
1381882|NCT01441401|Other Pre-specified|Response Ratio (R Ratio)|R Ratio was calculated by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: R Ratio = (T - B) / (T + B). R Ratio is within the range of -1 to +1, and a negative value represents a reduction in the frequency of seizure.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.|||Ratio||Standard Deviation|Mean
1381883|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)|Aggressive behaviors including affect lability and hostility were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined as the 101 preferred terms listed by pharmaceuticals and medical devices agency and classified according to MedDRA/J version 17.1. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
1381884|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)|Central nervous system depressant actions including somnolence and ataxia were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined according to MedDRA/J version 17.1 as the events classified in “psychiatric disorders” or “nervous system disorders” of the system organ classes, or those classified in “asthenia” or “gait disturbance” of the preferred terms. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
1381885|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period|Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term [less than 1 year] or long term [1 year or more]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
1381886|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
1381887|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 versus >8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
1381888|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
1381889|NCT01441401|Secondary|Number of Participants With Risk Factors for Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by each candidate risk factor (including gender, age, and disease eligible for the survey) to assess whether these were risk factors for the treatment-related adverse events. No inferential analyses of risk factors were performed because of a small number of the events (5 events).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. No data displayed because outcome measure has zero total participants analyzed.||||||
1381890|NCT01441401|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
1381891|NCT01441401|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population from which those with data not assessable were excluded. n=number of participants with assessable data at each post-baseline time point.|||Percentage of participants||95% Confidence Interval|Number
1381892|NCT01441401|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
1381893|NCT01441245|Secondary|Dopamine Infusion During Hospitalization||in-hospital||||percentage of partecipants|||Number
1381894|NCT01441245|Primary|Evaluation of Renal Function in Terms of GFR Values at Discharge||from admission to discharge, an average of 12 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant|||(ml/min·1.73 m2)||Standard Deviation|Mean
1381895|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in GFR||from admission to discharge, an average of 12 days||||(ml/min·1.73 m2)||Standard Deviation|Mean
1381901|NCT01441245|Primary|Evaluation of Mean Urine Output Volume During the Infusion Period|this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge|time period ranging from 72 h to 120 h.||||mL||Standard Deviation|Mean
1381902|NCT01441180|Primary|Sustained Virologic Response|Sustained virology response at 24 weeks post treatment completion|24 weeks post treatment completion|on protocol analysis|||percentage of total participants||95% Confidence Interval|Number
1381903|NCT01441180|Primary|Participants With Adverse Events|Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.|24 weeks||||partipants|||Number
1381904|NCT01441102|Secondary|Number of Participants Withdrawn From the Study Therapy Due to Vision Loss or Adverse Events||Duration of the study, up to 24 months||||participants|||Number
1381905|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 24 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 24 Months||||dB|eyes|Standard Deviation|Mean
1381906|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 18 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 18 Months||||dB|eyes|Standard Deviation|Mean
1381907|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 12 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 12 Months||||dB|eyes|Standard Deviation|Mean
1381908|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 6 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 6 Months||||dB|eyes|Standard Deviation|Mean
1381909|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 24 Months||||eyes|eyes||Number
1381910|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 18 Months||||eyes|eyes||Number
1381911|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 12 Months||||eyes|eyes||Number
1381912|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 6 Months||||eyes|eyes||Number
1381913|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months||||ETDRS letters|Eyes|Standard Deviation|Mean
1381914|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months||||ETDRS letters|Eyes|Standard Deviation|Mean
1381915|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 12 Months||||ETDRS letters|Eyes|Standard Deviation|Mean
1381916|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Two participants withdrew from the study prior to the 6-month visit.|||ETDRS letters|Eyes|Standard Deviation|Mean
1381917|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 24 Months||||percentage change in retinal thickness|eyes|Standard Deviation|Mean
1385439|NCT01402102|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/L||Standard Deviation|Mean
1381918|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 18 Months||||percentage change in retinal thickness|eyes|Standard Deviation|Mean
1381919|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 12 Months||||percentage change in retinal thickness|eyes|Standard Deviation|Mean
1381920|NCT01441102|Primary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 months|Two participants withdrew from the study prior to the 6-month visit.|||percentage change in retinal thickness|Eyes|Standard Deviation|Mean
1381921|NCT01441076|Secondary|Physician Global Score|Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381922|NCT01441076|Secondary|Patient Global Score|Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381923|NCT01441076|Secondary|Number of Oral Ulcers by Physician Evaluation|Number of oral ulcers noted by physician evaluation|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||oral ulcers in participants||Full Range|Median
1381924|NCT01441076|Secondary|Number of Genital Ulcers by Physician Evaluation|Number of genital ulcers noted by physician evaluation|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||genital ulcers in participants||Full Range|Median
1381925|NCT01441076|Secondary|Behcets Disease Current Activity Form (BDCAF) Score|The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381926|NCT01441076|Secondary|Behcet's Syndrome Activity Scale (BSAS) Score|The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381927|NCT01441076|Secondary|Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score|The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381928|NCT01441076|Secondary|Physician Global Score|Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381929|NCT01441076|Secondary|Patient Global Score|Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381930|NCT01441076|Secondary|Number of Oral Ulcers by Physician Evaluation|Number of oral ulcers noted by physician evaluation|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||oral ulcers in participants||Full Range|Median
1381931|NCT01441076|Secondary|Number of Genital Ulcers by Physician Evaluation|Number of genital ulcers noted by physician evaluation|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||genital ulcers in participants||Full Range|Median
1385440|NCT01402102|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/L||Standard Deviation|Mean
1381932|NCT01441076|Secondary|Behcets Disease Current Activity Form (BDCAF) Score|The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381933|NCT01441076|Secondary|Behcet's Syndrome Activity Scale (BSAS) Score|The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381934|NCT01441076|Secondary|Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score|The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
1381935|NCT01441076|Primary|Clinical Remission From Months 3-6|Clinical remission was defined as no oral or vaginal ulcers on physical examination for 2 consecutive monthly visits from months 3-6.|Monthly study visits from months 3-6 during the trial|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Participants|||Number
1381936|NCT01441037|Primary|Number of Patients Having Attenuation of Accelerated Telomere Attrition|The primary efficacy end point was a 20% reduction in the annual rate of telomere attrition measured at 24 months. The biologic response at 24 months, was defined as a reduction in the telomere length attrition rate to 96 bp per year or less. The normal rate of telomere loss of approximately 60 bp per year. Telomere length was determined with a semiautomated, Clinical Laboratory Improvement Amendments (CLIA)–approved real-time quantitative PCR (qPCR) assay performed in triplicate and validated for human cells|24 months|The analyses included only those subjects who took Danazol|||Participants|||Count of Participants
1381937|NCT01440972|Secondary|Change in Isokinetic Knee Extensor Strength||4 weeks||||Nm/kg||Standard Error|Least Squares Mean
1381938|NCT01440972|Secondary|Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.|4 weeks||||units on a scale||Standard Deviation|Mean
1381939|NCT01440972|Secondary|Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum||4 weeks||||Watts||Standard Deviation|Mean
1381940|NCT01440972|Secondary|Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging||4 weeks||||Percent change||Standard Deviation|Mean
1381941|NCT01440972|Primary|Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass||4 weeks||||kg per kg body mass||Standard Deviation|Mean
1381942|NCT01440959|Secondary|Overall Survival|Overall survival duration is calculated as time from the first treatment to the date of death. For patients who are still alive at the cut‐off date for statistical reporting, the overall survival duration will be right censored on the last known alive date.|Up to 3 years||||months||95% Confidence Interval|Median
1381943|NCT01440959|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Up to 3 years||||months||95% Confidence Interval|Median
1381944|NCT01440959|Secondary|Number of Participants With Adverse Events|Adverse events will be graded according to Common Terminology Criteria for Adverse events version 3.0, up to 3 year.|Monitoring of adverse events will be continued for at least 28 days following the last dose of study treatment, up to 3 year.||||participants|||Number
1381945|NCT01440959|Secondary|Efficacy According to the Concentrations of Circulating Growth Factors|Correlation between efficacy results, such as response, progression-free survival, and overall survival andcirculating growth factors (including vascular endothelial growth factor, fibroblast growth factor, interleukin‐8, placental growth factor, and fibroblast growth factor23), and soluble receptors (including soluble form of membrane bound vascular endothelial growth factor receptor-1 and -2).|Up to 24weeks|||||||
1381946|NCT01440959|Secondary|Efficacy According to the Primary Mutation Type|Correlation between efficacy results such as response, progression-free survival and overall survival, and primary mutation type including KIT exons 9, 11, 13, and 17 and PDGFRα exons 12 and 18.|Up to 24weeks|||||||
1381947|NCT01440959|Secondary|Overall Response Rate Using Both CT and PET Scans|PET scan will be performed at baseline and at 4 weeks of treatment. Metabolic response was defined based on the PET response criteria of the European Organization for Research and Treatment of Cancer (EORTC); a metabolic partial response (mPR) was defined as a 25% reduction in average SUVmax; metabolic stable disease (mSD) between a 25% decrease and 25% increase in average SUVmax; metabolic progressive disease (mPD) as a 25% increase in average SUVmax or the appearance of new uptake in metastatic lesions.|Up to 24 weeks||||Percentage of participants|||Number
1383811|NCT01424228|Secondary|Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||SCBM/week||Standard Deviation|Mean
1381948|NCT01440959|Primary|Disease Control Rate (DCR; OR + Stable Disease)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD~This was evaluated with abdominal and pelvic dynamic CT scan every 4 weeks for the initial 8 weeks, and then every 8 weeks."|Up to 24 weeks||||Percentage of participants||95% Confidence Interval|Number
1381949|NCT01440946|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|IR for FIX activity following rFIXFc dosing: IU/dL rise in plasma FIX per IU/kg drug administered. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1381950|NCT01440946|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|MRT: the average time for all the drug molecules to reside in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1381951|NCT01440946|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|DNAUC: dose normalized area under the drug concentration-time curve (extent of unmetabolized drug in circulation). Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1381952|NCT01440946|Secondary|Volume of Distribution at Steady State (Vss; One-stage aPTT Clotting Assay)|Vss: volume of distribution at steady state. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
1381953|NCT01440946|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|CL: the measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1381954|NCT01440946|Secondary|Terminal Half Life (t1/2; One-stage aPTT Clotting Assay)|t1/2: time required for the concentration of the drug to reach half of its original value in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
1381955|NCT01440946|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Cmax: maximum plasma FIX activity during a dosing interval. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL||95% Confidence Interval|Geometric Mean
1382051|NCT01440101|Secondary|Part B: Cumulative Number Of New Or Newly Enlarging, Non-Enhancing T2-Hyperintense Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions||Standard Deviation|Mean
1381956|NCT01440946|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.|||IU/kg|Bleeding Episodes|Inter-Quartile Range|Median
1381957|NCT01440946|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleeding episode, until the last date/time within the bleeding episode window are counted. The resolution of a bleeding episode is defined as no sign of bleeding following injection for the bleeding episode. For 'Per participant' values, the number of injections required to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
1381958|NCT01440946|Secondary|Number of Days From the Last Prophylaxis Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.|||days|Evaluable Spontaneous Bleeding Episodes|Inter-Quartile Range|Median
1381959|NCT01440946|Secondary|Annualized rFIXFc Consumption by Type of Injection|Annualized consumption of rFIXFc for prevention of bleeding (prophylactic), treatment of bleeding, and other rFIXFc injections. Consumption is calculated for the efficacy period. The efficacy period began with the first prophylactic dose of rFIXFc and ended with the last dose (regardless of the reason for dosing). Surgery/rehabilitation and PK evaluation periods were not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Participants who did not have a particular injection type are counted as having zero injections for that type.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.|||IU/kg rFIXFc per year||Standard Deviation|Mean
1381960|NCT01440946|Secondary|Physician's Global Assessment of the Participant's Response to His rFIXFc Regimen|Investigators assessed each participant's response to his rFIXFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFIXFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received ≥ 1 dose of rFIXFc; based on the number of responses.|||percentage of responses|responses||Number
1381961|NCT01440946|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response (provided by the caregiver) to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had ≥ 1 bleeding episode; based on the number of injections with an evaluation.|||percent of 1st injections w/ a response|Injections||Number
1381973|NCT01440816|Secondary|Time to Progression (TTP)|TTP is defined as the number of days between the treatment initiation date (Study Day 1) and the earliest date of documented disease progression as defined by RECIST 1.1 or death that is not associated with prior disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had document disease progression.|||days||95% Confidence Interval|Median
1381962|NCT01440946|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleeding episode=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. Efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended ≤ 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections ≤ 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken > 72 hours after the preceding 1 was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period is of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
1381963|NCT01440946|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended no more than 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period was of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
1381964|NCT01440946|Primary|Occurence of Factor IX (FIX) Inhibitor Development|An inhibitor test result ≥ 0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥ 50 exposure days (EDs) to rFIXFc. In addition, the incidence for all participants, regardless of their EDs to rFIXFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to 50 weeks +/- 7 days, or up to 50 EDs if reached prior to Week 50|Safety Analysis Set: participants who received at least 1 dose of prestudy FIX, or at least 1 dose of rFIXFc; n=number of participants with given number of EDs who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
1381965|NCT01440881|Primary|The Examine and Measure Urinary NGAL to Measure Kidney Injury|Urinary NGAL,a biomarker for kidney injury was measured.|A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.|randomized as outlined in protocol|||ng/ml||Inter-Quartile Range|Median
1381966|NCT01440881|Primary|The Examine and Measure Endothelin-1 to Measure Kidney Injury|Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1.|30 days from the start of infusion|randomized as outlined in the protocol|||pg/ml||Inter-Quartile Range|Median
1381967|NCT01440881|Primary|The Examine and Measure Cytokines to Measure Kidney Injury|Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.|30 days from the start of infusion|randomized per protocol|||pg/ml||Inter-Quartile Range|Median
1381968|NCT01440881|Primary|Measure Neutrophils to Measure Kidney Injury|0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression.|30 days from the start of infusion||||log2 expression||Standard Deviation|Mean
1381969|NCT01440816|Secondary|Distant Regression Rate|Distant regression rate is defined as the percentage of participants with ≥30% regression (decrease in size) of at least one assessed distant (non-injected) lesion.|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|All patients from Cohorts A and B with evaluable lesions.|||percentage of participants|||Number
1381970|NCT01440816|Secondary|Local Regression Rate|Local regression rate is defined as the percentage of participants with ≥30% regression (decrease in size) of at least one assessed local (injected) lesion.|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|All patients from Cohorts A and B with evaluable lesions.|||percentage of participants|||Number
1381971|NCT01440816|Secondary|Immunologic Effects of IT pIL-12 Injection and In Vivo EP Measured By: Percentage of Participants With a Positive Fold Change (Log2) in IL-12A Messenger Ribonucleic Acid (mRNA) for Patient Pre- and Post IT pIL 12 EP|Nanostring analysis was performed to determine the expression (mRNA) of IL-12. For each study patient, the fold change (log2 transformed) in IL-12A mRNA as measured by Nanostring was determined using the pre-treatment (screening) biopsy as a reference for the post treatment biopsy. A log2 fold change >=1 is a positive result.|Pre-treatment up to Week 13|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had evaluable lesions.|||percentage of participants|||Number
1381972|NCT01440816|Secondary|Overall Survival|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|From the start of study treatment until death (up to 15 months)|Efficacy Analysis Set, all patients who received any amount of the study drug (tavo). Zero participants were analyzed for overall survival because all patients were alive at their study completion visit.||||||
1385441|NCT01402102|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
1381974|NCT01440816|Secondary|Objective Response Rate (ORR) in Injected and Non-injected (Distant) Lesions|"ORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.~The same method was used to assess response rate for treated lesions and response rate for non-treated lesions. The best response rate for non-treated lesions was based on the number of patients who had at least one non-treated lesion."|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had evaluable lesions.|||percentage of participants|||Number
1381975|NCT01440816|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.|From signing of informed consent to 8 weeks after the last dose of study treatment (up to 15 months)|Safety Analysis Set, all patients who received any amount of the study drug (tavo).|||percentage of participants|||Number
1381976|NCT01440816|Primary|Percentage of Participants Who Experienced At Least 2-Fold Increase in Expression of IL-12 Protein in the Tumor Tissue After Intratumoral (IT) pIL-12 Injections and In Vivo Electroporation|The MAGPIX assay was used to assess differential expression of hIL-12 in patient tumor tissue before and after treatment with intratumoral (IT) tavo injections and in vivo electroporation (EP). Expression of hIL-12 was used to identify patients who met the primary endpoint of a 2-fold or higher increase in expression of hIL-12 in tumors after treatment. Fold change was taken as a comparison of hIL-12 expression at Week 3:pre-treatment, Week 6:pre-treatment, Week 8:pre-treatment, or Week 13:pre-treatment over baseline (pre- treatment). The fold change was calculated as log2 (time point/baseline).|Pre-treatment up to Week 13|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo).|||percentage of participants|||Number
1381977|NCT01440764|Secondary|Urine Output|Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed into the blood, diuresis is an expected 'side effect' of this treatment|Cumulative urine output 1 hour after intervention||||ml of urine||Standard Deviation|Mean
1381978|NCT01440764|Secondary|Multidimensional Dyspnea Profile|Characterization of subject's response to laboratory dyspnea model. Data are from a baseline pre-treatment test on the first drug or placebo treatment day for the subjects used in the main analysis. Subjects were asked to complete the MDP with reference to the last 30 sec of each run. To weigh subjects equally, we selected one run from each subject: the first run that terminated in a rating of overall breathing discomfort (A1) of 50 to 90% of full scale. The units of measurement are expressed as units on a 0 to 10 scale measuring intensity of a given quality, with higher values indicating greater intensity and 10 representing maximum perceived intensity.|Measured before intervention||||units on a scale||Standard Error|Mean
1381979|NCT01440764|Primary|Subject Rating of Breathing Discomfort (Dyspnea)|Change in breathing discomfort (dyspnea) rating at benchmark PETCO2 using a visual analog scale. The change in breathing discomfort is expressed as units on a 0% to 100% continuous scale, where higher values represent more dyspnea. The change is represented as the rating of breathing discomfort after the intervention minus the rating of breathing discomfort before the intervention.|The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.||||units on a scale||Standard Error|Mean
1381980|NCT01440647|Secondary|Percentage of Participants With Reintubation|Reintubation rate is a measure of the efficacy of NIPPV.|0-7 days post-extubation||||% of participants with reintubation|||Number
1381981|NCT01440647|Primary|Number of Days Being Intubated||30 days from birth||||days||Full Range|Median
1381982|NCT01440634|Primary|Effect of an Exercise Intervention on Walking Ability (Functional Outcome)|Walking distance (Six-Minute Walk test). Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible. A research assistant walks slightly behind each participant so as not to pace the individual. The research assistant records whether or not each person stops during the 6-minute walk. During the proposed study, members of the research team and trained lay health promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked.|6 months||||meters||Standard Deviation|Mean
1381983|NCT01440595|Secondary|Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
1381984|NCT01440595|Secondary|Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
1385442|NCT01402102|Secondary|Changes in Triglycerides|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis|||mg/dl||Standard Deviation|Mean
1381985|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)|SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
1381986|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)|SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
1381987|NCT01440595|Secondary|Number of Participants Achieving Rapid Viral Response (RVR)|RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 4|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
1381988|NCT01440595|Secondary|Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)|Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
1381989|NCT01440595|Primary|Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
1381990|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48||Up to 48 weeks|Full Analysis Set|||percentage of participants|||Number
1381991|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24||Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1381992|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
1381993|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.|||cells/μL||Standard Deviation|Mean
1381994|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)||Week 48|Full Analysis Set|||percentage of participants|||Number
1381995|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)||Week 24|Full Analysis Set|||percentage of participants|||Number
1381996|NCT01440569|Primary|Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24||Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
1381997|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.|6 months|Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant.|||percentage of all participants|||Number
1381998|NCT01440543|Secondary|Patient Comfort During the Procedure and During First 24 Hours After Procedure|Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure|six months|||||||
1381999|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.|six months|||||||
1382000|NCT01440517|Secondary|Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.||||||
1382001|NCT01440517|Primary|Evidence of Active Myocardial Angiogenesis/Remodeling|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.||||||
1382002|NCT01440387|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1382003|NCT01440387|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1382004|NCT01440387|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were chest tightness, chills, cough, fatigue, headache, joint pain at other location, muscle pain, red eyes, sore throat, swelling of the face and fever [oral temperature ≥ 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1382005|NCT01440387|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling greater than 100 millimeters (mm). i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1382006|NCT01440387|Primary|HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.|SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1382007|NCT01440387|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1382008|NCT01440387|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1382009|NCT01440387|Primary|Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.|Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1382010|NCT01440374|Secondary|EQ-5D Utility Score Analysis|"EuroQoL Five Dimensions Questionnaire (EQ-5D) is a standardized generic preference based health related quality of life instrument. It records how one’s health is “today” and consists of a descriptive system. The Descriptive system is Comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem(s) and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects’ health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life.~EQ-ED is a score."|Change from baseline, up to week 12|Part 2 Population (Intent-to-Treat population)|||Adjusted mean change from baseline||Standard Error|Mean
1385448|NCT01402011|Other Pre-specified|Total Prescription Pain Medication Used|Total amount of narcotic pain medication prescribed. Data were not collected at 1,2,3 and 6 months.|20 minutes before first injection on first day of patient visit|||||||
1382011|NCT01440374|Secondary|Functional Assessment of Cancer Therapy (FACT)|"The FACT-Th-18 is the most widely used and accepted tool evaluating health-related quality-of-life outcomes in cancer patients with chronically low platelets (where Th designates thrombocytopenia). The entire FACT-Th-18 was used in this trial, which includes the 18-item thrombocytopenia subscale used to assess the impact of symptoms, signs, and functional consequences of thrombocytopenia in MDS and AML subjects. The FACT-Th-18 is a validated and reliable instrument with known psychometric properties. FACT-ThS is an 18 item questionnaire specific to assessing the impact of symptoms, signs, and functional consequences of Thrombocytopenia. ThS score ranges from 0 to 72 with higher the score, the better the QoL. FACT G total score moves from 0 to 108 where higher the score, the better the HRQL.~FACT-Th Total Score is calculated by adding the FACT-ThS and FACT-G score. Total score ranges from 0 to 180 and again, higher the score, the better the HRQL."|Change from baseline, up to week 12|Part 2 Population (Intent-to-Treat population)|||Adjusted mean change from baseline||Standard Error|Mean
1382012|NCT01440374|Secondary|Summary of Health Outcomes|"The number of subject with medical resource utilization (MRU) data are reported in this table.~MRU included number of emergency room visits, number of home healthcare visits, number of hospitalization days, number of medication or surgery specialist visits, number of procedures inpatient, number of procedures outpatient, number of non-study radiology visits, number of non-study laboratory visits, number of nurse practitioner/physician assistance/nurse visits, number of primary care physician visits, number of telephone consultations."|week 12|Part 2 Population (Intent-to-Treat population)|||Subject with Events|||Number
1382013|NCT01440374|Secondary|Median Overall Survival||Up to 13 months|Part 2 Population (Intent-to-Treat population)|||Months||95% Confidence Interval|Median
1382014|NCT01440374|Secondary|Independent Reviewer Assessed Disease Progression||Up to week 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
1382015|NCT01440374|Secondary|Independent Reviewer-Assessed Best Response|Participants were evaluated in accordance with the modified International Working Group (Cheson, 2006). CR: Bone marrow blasts <5%, Hgb ≥11g/dL, Hematologic Improvement – Platelets (Baseline <20Gi/L: >20 Gi/L and 2x baseline; Baseline ≥20 Gi/L: ≥50 Gi/L and 2x baseline), Neutrophils ≥1.0 Gi/L, Peripheral blasts 0%. PR: Bone marrow blasts decreased by ≥50% but >5%, Peripheral blood as in CR. Marrow CR: Bone marrow blasts <5% and decrease by ≥50%, Note any Hematologic Improvements, Stable disease: Failure to achieve PR, but no evidence of progression for >8w, Cytogenetic response: Complete: disappearance of chromosomal abnormality; no new abnormalities Partial: ≥50% reduction of chromosomal abnormality.|up to week 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
1382016|NCT01440374|Secondary|Number of Participants With Maximum Bleeding Grade According to World Health Organization on Bleeding Scale|Occurrence and severity of bleeding, measured using the WHO Bleeding Scale Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross blood loss; Grade 4=debilitating blood loss.|Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
1382017|NCT01440374|Secondary|Maximum Duration of Platelet Transfusion Independence||Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||maximum duration of platelet transfusion||Standard Deviation|Mean
1382018|NCT01440374|Secondary|Change in Mean Platelet Count||Baseline to Week 12|Part 2 Population (Intent-to-Treat population)|||Gi/L||Standard Deviation|Mean
1382019|NCT01440374|Secondary|Hematologic Improvement|Definitions of hematologic improvement for platelets, neutrophils, and hemoglobin were based on modified International Working Group (IWG) consensus criteria.|Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
1382020|NCT01440374|Secondary|Mean Number of Platelet Transfusions||Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||Number of platelet transfusions||Standard Deviation|Mean
1382021|NCT01440374|Secondary|Plasma Eltrombopag Pharmacokinetic Concentration-Time Data - by Visit (Part 2 Subjects)||Day 1 to week 12|Pharmacokinetic population|||ug/mL||Standard Deviation|Mean
1382022|NCT01440374|Secondary|Plasma Eltrombopag Pharmacokinetic Concentration-Time Data - by Visit (Part 1 Subjects)||Day 1 to week 8|Pharmacokinetic population: all subjects in All Subjects Population who had a PK blood sample obtained/analyzed.|||ug/mL||Standard Deviation|Mean
1382023|NCT01440374|Primary|Clinically Relevant Thrombocytopenic Events (CRTE) From Week 5 up to Week 12 During Part 2|A participant was considered to have a CRTE at a given assessment if he/she had platelet counts <10 Gi/L, or platelet transfusions, or >=Grade 3 hemorrhagic adverse events. CRTEs during Weeks 5 to 12 were compared between treatments using a generalized linear mixed model. Average of weekly proportion of subjects with CRTE during Week 5 to 12 was estimated for each treatment. Intent to Treat (ITT) Population was comprised of all randomized participants during Part 2.|From Week 5 up to Week 12 during Part 2|Part 2 Population (Intent-To-Treat (ITT) Population: all randomized subjects in part 2)|||percentages of participants||95% Confidence Interval|Mean
1382024|NCT01440374|Primary|Number of Participants With Platelet Response up to Week 8 During Part 1|A participant was considered as a responder if he/she met the following response criteria: a Baseline platelet count <20 Giga cells per liter (Gi/L) and a post-Baseline increased to >20 Gi/L and at least 2 times the Baseline value; or a Baseline platelet count >=20 Gi/L and a post-Baseline absolute platelet count increased to >=50 Gi/L and at least 2 times the Baseline value. The response criteria was evaluated at each visit. Increase in platelet count observed up to 3 days after a platelet transfusion was not considered as a platelet response. The Part 1 Population was comprised of all participants enrolled into Part 1.|From Baseline up to Week 8 during Part 1|Part 1 Population: all subjects who enrolled in Part 1.|||Participants|||Number
1382025|NCT01440322|Secondary|Back Surface Deposits (None, Very Slight)|"Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
1382037|NCT01440283|Primary|Percentage of Participants Who Failed to Reach Local-regional Control|Measured from start of radiation therapy to date of local-regional failure or last follow-up.|2 years after last patient enrollment||||percentage of participants|||Number
1382026|NCT01440322|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
1382027|NCT01440322|Secondary|Dry Areas/Non-Wetting (None, Very Slight)|"Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
1382028|NCT01440322|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
1382029|NCT01440322|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
1382030|NCT01440322|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."|||Units on a scale||Standard Deviation|Mean
1382031|NCT01440322|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."|||Units on a scale||Standard Deviation|Mean
1382032|NCT01440322|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."|||Units on a scale||Standard Deviation|Mean
1382033|NCT01440322|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of eyes|Participants||Number
1382034|NCT01440283|Secondary|Quantify (in mm/cm) the Range of Target Movement During the Breathing Phase Measured by 4DMRI and 4DCT.|Obtain target tissue motion-defining data which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue.|Baseline and approximately 2 weeks following initiation of irradiation.|All participants underwent complete surgery prior to RT, therefore, no visible tumor tissue target was available for movement measurements.||||||
1382035|NCT01440283|Secondary|Quantify the Range of Organ Movement During the Breathing Phase Measured by 4-dimensional MRI (4DMRI) and 4DCT.|Normal tissue motion-defining measurements were obtained which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue. Participants underwent CT simulation and 4D-CT acquisition as well as real-time dynamic 4D MRI prior to the start of radiation therapy (RT), and a subsequent repeat 4D-CT was obtained approximately 2 weeks after the start of RT. The imaging position was supine with general anesthesia. Renal edges were marked in a customized graphical interface for each imaging series with the image resolution determining the minimum motion extent. Vectors of renal edge motion were quantified in the anterior-posterior (A-P), medial-lateral (M-L), and superior-inferior (S-I) dimensions. The motion extent derived from the MRI dataset was considered in defining the margins for RT treatment planning.|Baseline and approximately 2 weeks following initiation of irradiation.|Five participants did not receive all scans for motion evaluations and are excluded from the analysis. Age at scan ranges from 8 months to 9.5 years old. The median age was 3.8 years.|||mm||Standard Deviation|Mean
1382036|NCT01440283|Primary|Pattern of Local-regional Failure.|Categorical measurements of local-regional failure.|2 years after last patient enrollment|There was no local-regional failure noted (please see outcome #1), therefore, no pattern of failure could be determined.||||||
1382039|NCT01440101|Secondary|Part A: Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)|Pharmacodynamic activity was assessed by measuring the degree of saturation by BG00002 of the very late antigen-4 (VLA-4, also known as α4β1 integrin) receptor on peripheral blood mononuclear cell populations. This was accomplished by staining cells with phycoerythrin-conjugated anti-human immunoglobulin G4 (IgG4) antibody (hIgG4-PE) to label the cell-bound BG00002, followed by flow cytometric detection and quantification.|Pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose; Weeks 8, 12, and 16: pre-dose; Week 20: pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of α4-integrin saturation; n=participants with an assessment at timepoint.|||percent saturation||Standard Deviation|Mean
1382040|NCT01440101|Secondary|Part B: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24||||participants|||Number
1382041|NCT01440101|Secondary|Part B: Status of Serum Antibodies to Natalizumab|Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Baseline (Week 0) and Week 24|Participants with one or more post-baseline screening antibody result.|||participants|||Number
1382042|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: CL|Systemic clearance (CL) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration.|||mL/h||Full Range|Geometric Mean
1382043|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Vd|Volume of distribution (Vd) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||L||Full Range|Geometric Mean
1382044|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Tmax and T1/2|Time to maximum concentration (Tmax) and half-life (T1/2) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||hours||Full Range|Geometric Mean
1382045|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: AUC(0-last) and (0-AUC∞)|Area under the curve to the last measurable concentration (AUC[0-last]); and area under the curve extrapolated to infinity (0-AUC∞) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||µg*h/mL||Full Range|Geometric Mean
1382046|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Cmax|Observed maximum concentration (Cmax) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||µg/mL||Full Range|Geometric Mean
1382047|NCT01440101|Secondary|Part B: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Baseline (Week 0), Week 12, Week 24|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint. Participants with values <LLQ were not counted in the n for that timepoint.|||µg/mL||Standard Deviation|Mean
1382048|NCT01440101|Secondary|Part A: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Week 0: pre-dose, post-dose and 2, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose; Weeks 4, 8, 12, and 16: pre-dose; Week 20 pre-dose, post-dose, and 2, 24, 48 and 96 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants who received at least 1 infusion of BG00002 with at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of participants with an assessment at given timepoint. At Weeks 8, 12, and 16, one participant had values less than the lower limit of quantitation (<LLQ) and was not counted in the n for that timepoint.|||µg/mL||Standard Deviation|Mean
1382049|NCT01440101|Secondary|Part B: Change From Baseline to Weeks 12 and 24 in the Global Assessment of Well-Being As Assessed by Participants Using a Visual Analog Scale (VAS)|The participant's self-rating of global impression of his/her well-being was assessed with a VAS. The instrument ranged from 0 to 100 (mm), where a score of 0 denoted 'poor' and a score of 100 denoted 'excellent.'|Baseline (Week 0), Week 12, Week 24|n = all participants with an assessment at baseline and given timepoint.|||units on a scale||Standard Deviation|Mean
1382050|NCT01440101|Secondary|Part B: Number of Participants Who Were Relapse Free Over 24 Weeks|Participants were categorized as relapse free=yes, relapse free=no, or relapse free=unknown. The category of relapse free=unknown includes participants who withdrew from the study and did not experience a relapse prior to withdrawal.|Baseline (Week 0) to Week 24|All participants who received study drug.|||participants|||Number
1382052|NCT01440101|Secondary|Part B: Cumulative Number of Gd+ Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions||Standard Deviation|Mean
1382053|NCT01440101|Secondary|Part B: Adjusted Annualized Relapse Rate Over 24 Weeks|The frequency of clinical exacerbations over 24 weeks was assessed using an annualized relapse rate that was calculated for each treatment group as the total number of relapses experienced in the group over the 24 weeks of treatment, divided by the total number of subject-years followed in the study. Obtained from a Poisson regression model, adjusted for the baseline relapse rate.|Week 24||||relapses per year|Participants|95% Confidence Interval|Number
1382054|NCT01440101|Secondary|Part B: Cumulative Number of New Active Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions||Standard Deviation|Mean
1382055|NCT01440101|Primary|Part B: Rate of Development of New Active Lesions Over 24 Weeks|New active lesions were the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly enlarging T2 hyperintense lesions that did not enhance as seen on cranial magnetic resonance imaging (MRI) scans. The rate is calculated for each participant as the ordinary least squares slope of the cumulative new active lesions over time.|Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions per week over 24 weeks||Standard Deviation|Mean
1382056|NCT01440101|Primary|Part A: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24|All participants who received study drug.|||participants|||Number
1382057|NCT01440049|Other Pre-specified|Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population|Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.|Baseline|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382058|NCT01440049|Other Pre-specified|Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population|New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.|Baseline, Months 3, 6, 9, 12|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||Percentage of participants||95% Confidence Interval|Number
1382059|NCT01440049|Other Pre-specified|Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.|Baseline up to Month 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||mmol/L||Standard Deviation|Mean
1382060|NCT01440049|Other Pre-specified|Maximum Kalaemia Levels in Serum in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||mmol/L||Standard Deviation|Mean
1382061|NCT01440049|Other Pre-specified|Number of Measurements Per Month for Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.|Months 3, 6, 9, 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||Measurements per month||Standard Deviation|Mean
1382062|NCT01440049|Other Pre-specified|Percentage of Participants With General Practitioner (GP) Consultation in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.|||Percentage of participants||95% Confidence Interval|Number
1392158|NCT01335932|Secondary|Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma|Number of participants with CMV reactivation >1,000 IU per mL at day 28 in plasma|at 28 days post-randomization||||Participants|||Count of Participants
1382063|NCT01440049|Other Pre-specified|Percentage of Participants With Other Notable Events in FAS Population|Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.|||Percentage of participants||95% Confidence Interval|Number
1382064|NCT01440049|Secondary|Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population||Baseline up to Month 12|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382065|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in SAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|SAS population included all participants who received study medication.|||Participants|||Number
1382066|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in FAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.|||Participants|||Number
1382067|NCT01440049|Secondary|Number of Participants With Reason for Increased or Decreased Eplerenone Dose||Baseline up to Month 12|Data were not statistically summarized and were provided in individual participant listings as per the planned analysis.||||||
1382068|NCT01440049|Primary|Number of Participants With Worsened Renal Function||Baseline up to Month 12|Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study.||||||
1382069|NCT01440049|Primary|Percentage of Participants Hospitalized in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382070|NCT01440049|Primary|Percentage of Participants Who Died in SAS Population||Baseline up to Month 12|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382071|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382072|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382073|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382074|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) – dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 3|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||Percentage of participants||95% Confidence Interval|Number
1382075|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382088|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Prothrombin Time (PT)|PT measures how long it takes blood to clot. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||seconds||Standard Deviation|Mean
1382076|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382077|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382078|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population|Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.|Month 3|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1382079|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of EDV||Standard Deviation|Mean
1382080|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of EDV||Standard Deviation|Mean
1382081|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Peak Thrombin Generation|The peak height is defined as the maximum thrombin concentration produced. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||Nanomolar (nM)||Standard Deviation|Mean
1382082|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time|The lag time is defined as the time to reach one sixth of the peak height and is a measure of the initiation phase. It is equivalent to the clotting time. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||minutes||Standard Deviation|Mean
1382083|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP)|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex-vivo assay that measures the ability of plasma to generate thrombin. Thrombin generation curves are generated and calculated using dedicated software. ETP is the area under the thrombin generation curve and represents the total amount of generated thrombin. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||nanomolar*minute (nM*min)||Standard Deviation|Mean
1382084|NCT01439971|Secondary|Maximum Mean Increase From Baseline in D-Dimers|D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||ng/mL||Standard Deviation|Mean
1382085|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2|Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated Factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
1382086|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes|TAT complex is a parameter of coagulation and fibrinolysis. The normal reference range of values for TAT is 1 to 4.1 mcg/L. Elevated TAT concentrations may signify predisposition to thrombosis. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||mcg/L||Standard Deviation|Mean
1382087|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT)|aPTT is a blood test that characterizes blood coagulation. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||seconds||Standard Deviation|Mean
1383812|NCT01424228|Secondary|Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||SCBM/week||Standard Deviation|Mean
1382089|NCT01439971|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
1382090|NCT01439971|Secondary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose is influenced by the fraction of the dose absorbed.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||L/hr/kg||Geometric Coefficient of Variation|Geometric Mean
1382091|NCT01439971|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
1382092|NCT01439971|Secondary|Mean Residence Time (MRT)|MRT is AUMCinf/AUCinf, where AUMC is the area under the first moment curve.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hours||Standard Deviation|Mean
1382093|NCT01439971|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf is area under the plasma concentration-time curve from time 0 extrapolated to infinite time.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1382094|NCT01439971|Secondary|Incremental Recovery (IncRec)|IncRec is the maximum rise in plasma concentration per administered dose.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng/mL/mcg/kg||Geometric Coefficient of Variation|Geometric Mean
1382095|NCT01439971|Secondary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by one half.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hour||Standard Deviation|Mean
1382096|NCT01439971|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1382097|NCT01439971|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1382098|NCT01439971|Primary|Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)|Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive ELISA result in combination with a negative baseline sample ELISA result. Positive antibody immune responses to PF-05280602 by ELISA was evaluated for cross reactivity to NovoSeven RT and to Factor VII.|Baseline through Day 60|The immunogenicity parameter population included enrolled and treated participants with at least 1 post-treatment anti-PF-05280602 antibody (ADA), PF-05280602 inhibitor, or Factor VII activity level determination.|||participants|||Number
1382099|NCT01439971|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria|Clinically significant findings for stopping rules are: hemoglobin <8 grams/deciliter (g/dL) or >20% decrease from normal baseline; WBC >20,000 cells/mm^3 or <1,500 decrease with normal baseline; platelets <100,000/mm^3 or >33% decrease from baseline; total bilirubin >1.5X ULN; AST or ALT >2.5X ULN; alkaline phosphatase >3X ULN; creatinine >1.5X baseline; BUN >31.0 mg/dL; glucose <0.6 or >1.5X reference range; uric acid > ULN; sodium >150 or <130 mEq/L; potassium >5.5 or <3.0 mEq/L; calcium >11.5 or <8.0 mg/dL; albumin <2.0 g/L; total protein <5.0 g/L; positive D-dimer at Day 15; PT prolonged by 3 seconds above baseline; ATIII < LLN and >20% decrease from baseline; troponin-T values above the reference range; fibrinogen <0.75X LLN or >25% decrease from baseline.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382100|NCT01439971|Primary|Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline)|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, creatinine, blood urea nitrogen [BUN], glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase); urinalysis (urine white blood cell [WBC], urine RBC); other (troponin T).|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382101|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude|TFPI is a polypeptide that can regulate blood coagulation. TFPI levels of potential clinical concern are values <1X LLN and >1X ULN.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382102|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude|ATIII is a protein in the blood that blocks abnormal blood clots from forming. Low levels of ATIII can cause abnormal blood clots. ATIII levels of potential clinical concern are values <1X LLN and >1X ULN.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382103|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude|Troponin-T is a cardiac marker for the evaluation of possible cardiovascular injury. Troponin-T levels of potential clinical concern are values >1.5 times the upper limit of normal (1.5X ULN) or >=2.5X ULN.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382104|NCT01439971|Primary|Number of Treatment-Emergent Hemophilia AEs by Severity|Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||adverse events|||Number
1382105|NCT01439971|Primary|Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs)|AE severity were graded as mild, moderate, or severe. Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||adverse events|||Number
1382106|NCT01439971|Primary|Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs|Hemophilia AEs included spontaneous (no known contributing factor) and traumatic (known or presumed contributing factor/reason) bleeding episodes.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382107|NCT01439971|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 15 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382108|NCT01439971|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG findings of potential clinical concern were: PR interval greater than or equal to (>=)300 milliseconds (msec), >=25% increase from baseline for baseline values >200 msec, >=50% increase from baseline for baseline values less than or equal to (<=)200 msec; QRS complex >=140 msec or >=50% increase from baseline; QTcF interval (Fridericia's correction) >=450 msec or >=30 msec increase from baseline.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382109|NCT01439971|Primary|Number of Participants With Changes Since Previous Physical Examination|Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner. A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, genitourinary, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline (Day 0), Day 1, Day 2, Day 3, Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
1382110|NCT01439971|Primary|Change From Baseline in Supine Pulse Rate|Change from baseline is the vital sign value at Day 2, Day 3, and Day 15 minus vital sign value at baseline.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||beats per minute (bpm)||Standard Deviation|Mean
1382111|NCT01439971|Primary|Change From Baseline in Respiration Rate|Respiration rate measured as respirations per minute (resp/min).|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||resp/min||Standard Deviation|Mean
1382112|NCT01439971|Primary|Change From Baseline in Body Temperature|Body temperature was measured by mouth (oral) or ear (tympanic). A temperature greater than 38.5 degree Celsius was considered a fever.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||degree Celcius||Standard Deviation|Mean
1382113|NCT01439971|Primary|Change From Baseline in Body Weight||Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||kilograms (kg)||Standard Deviation|Mean
1382114|NCT01439971|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Supine blood pressure (BP) was measured with the participant’s arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||mmHg||Standard Deviation|Mean
1382125|NCT01439867|Secondary|Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study|A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
1383540|NCT01426438|Secondary|Change in Cholesterol|Absolute change in total cholesterol from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan and had lipid panels at weeks 0 and 24.|||mg/dL||Inter-Quartile Range|Median
1382115|NCT01439945|Secondary|The Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms.|"The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms will be compared using a repeated measures model.~Serum magnesium concentrations will be performed prior to study medication usage and during the last week of blinded study use. These will be obtained in the first 150 patients. Mean change in serum magnesium concentrations will be compared between the 3 study arms to determine whether there are any apparent changes in the patients receiving placebos vs the two magnesium doses."|Baseline to week 8|All patients that started protocol treatment and had serum magnesium levels obtained at baseline and week 9 were included in this analysis.|||mg/dL||Standard Deviation|Mean
1382116|NCT01439945|Secondary|The Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination.|"We will use the Hot Flash Related Daily Interference Scale (HFRDIS) (SEQ) to evaluate the specific effect of hot flashes have on various life activities such as work, social, leisure and relationships while receiving treatment. The questionnaire is 10 questions and is based on a 0=Do not interfere to 10=Completely interfere scale. The weekly score is the summation of these 10 questions and therefore ranges from 0 to 100. The total change in severity of symptoms is calculated by subtracting the week 8 score from the baseline. Therefore, values below zero indicate a worsening of symptoms and values above zero indicate an improvement and has a maximum range of -100 to 100. A gatekeeper procedure, following a fixed-sequence hypothesis testing method, was used to examine the higher dose of magnesium vs. placebo first and then the lower dose of magnesium vs. placebo, if the former was statistically significant."|Baseline to week 8|All patients that began treatment and completed the HFRDI questionnaire at baseline and week 8 were used in this analysis.|||units on a scale||Full Range|Median
1382117|NCT01439945|Secondary|The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination|"We will use the Symptom Experience Questionnaire (SEQ) to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. The questionnaire is 14 questions and is based on a 0=Not at all to 10=As bad as it can be scale. The change of severity of symptoms as measured by the SEQ from baseline to treatment termination will be first summarized by descriptive statistics as a percent change from baseline."|Baseline to week 8|All patients that started treatment and completed the Symptom Experience Questionnaire at baseline and Cycle 9 were included in this analysis.|||percentage change||Full Range|Median
1382118|NCT01439945|Secondary|Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period.|Frequency and severity of adverse events reported by patients in weekly Symptom Experience Questionnaire and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Baseline to Week 8|All patients that started protocol treatment and were evaluated for adverse events are included in this analysis.|||Participants|||Count of Participants
1382119|NCT01439945|Secondary|Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period|As part of the Hot Flash Diary, the number of hot flashes was recorded for each patient for each week. For this endpoint, the mean number of hot flashes for each group is reported. A repeated measure analysis comparing each dose level group and the Placebo is reported.|Baseline to Week 8|All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.|||number of hot flashes||Standard Deviation|Mean
1382120|NCT01439945|Primary|The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period.|"The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes.~The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week.~The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group."|Baseline to Week 8|All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.|||units on a scale||Standard Deviation|Mean
1382121|NCT01439867|Secondary|Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet||Week 12|The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.|||hr*ng/mL/(mgkg)||Standard Deviation|Mean
1382122|NCT01439867|Secondary|Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet||Week 12|The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.|||ng/mL/(mgkg)||Standard Deviation|Mean
1382123|NCT01439867|Secondary|Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study|A participant was considered to have achieved iPTH < 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was < 300 pg/mL.|26 weeks|The analysis included all enrolled subjects with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
1382124|NCT01439867|Secondary|Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements|A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
1382296|NCT01438307|Secondary|Number of Patients With Any Graded Adverse Event|Safety will be assessed using the National Cancer Institute Common Toxicity Criteria (Version 4.0) and all adverse events will be recorded prior to each treatment regimen.|Baseline up to 28 months|14 patients in each cohort were included in the toxicity assessment and 13 patients in each cohort in the efficacy assessment.|||Participants|||Count of Participants
1382126|NCT01439867|Secondary|Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements|A participant was considered to have achieved > 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were < -30% regardless if there was a missing value in between.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
1382127|NCT01439867|Secondary|Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
1382128|NCT01439867|Secondary|Percent Change From Baseline in Serum Phosphorous||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
1382129|NCT01439867|Secondary|Percent Change From Baseline in Corrected Serum Calcium||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
1382130|NCT01439867|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
1382131|NCT01439867|Secondary|Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study||26 weeks|The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).|||percentage of participants||90% Confidence Interval|Number
1382132|NCT01439867|Primary|Percentage of Participants With Hypocalcemia|Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.|26 weeks|The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).|||percentage of participants||90% Confidence Interval|Number
1382133|NCT01439724|Secondary|Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.|Oral mucositis survival free, pain, opioid treatment, hospitalization, treatment interruption, treatment delay, patient weight loss, nasogastric tube or of a gastrostomy.The oral cavities of all patients were evaluated, from the first day to the last day of treatment.|7 weeks|||||||
1382134|NCT01439724|Primary|Incidence and / or Severity of Oral Mucositis|The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.|7 weeks|Data related to the primary endpoint were handled in a per protocol treatment analysis.|||Grade 3-4 oral mucositis|||Number
1382135|NCT01439711|Secondary|Mean Total MRI Tumor Diameter Change From Baseline to Month 6|To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary outcome #2 will be used but on diameter instead of volume. For patients with more than one lesion longest diameter measurement, the sum of all lesion longest diameter measurements was calculated.|6 months||||millimeters||95% Confidence Interval|Mean
1382136|NCT01439711|Secondary|Mean Total MRI Tumor Diameter Change From Baseline to Month 6|Mean total MRI tumor diameter change from baseline to month 6: To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary Outcome #2 will be used but on diameter instead of volume.|6 months||||millimeters||95% Confidence Interval|Mean
1382137|NCT01439711|Secondary|Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.|Up to 6 months post surgery|Patients who had completed the study and had an Adverse Event Form submitted were included in this analysis.|||Participants|||Count of Participants
1382138|NCT01439711|Secondary|Size of Margins (Smallest) at Surgery||3-months and 6-months|||||||
1382139|NCT01439711|Secondary|Presence of Invasive Cancer at Surgery||3-months and 6-months|||||||
1382140|NCT01439711|Secondary|Extent of Residual DCIS Post Surgery||Up to 6 months post-surgery|||||||
1382141|NCT01439711|Secondary|Number of Re-excisions Required to Obtain Clear Margins||3-months and 6-months|||||||
1382142|NCT01439711|Secondary|Type of Primary Surgery (Mastectomy or Lumpectomy)|Rate of Mastectomy will be estimated as the number of mastectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods. Rate of Lumpectomy will be estimated as the number of lumpectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods.|up to 6 months|Patients who underwent surgery were included in this analysis.|||percentage of surgeries||95% Confidence Interval|Number
1382143|NCT01439711|Secondary|Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6)|Change in maximum diameter at 6-months based on mammographic measurement (MD6) will be estimated using the methods in Primary Outcome #1, but using the mammographic measurements instead.|6-months|Patients who completed a mammogram at both time points (baseline and month 6) with measurements available were included in this analysis.|||millimeters||95% Confidence Interval|Mean
1382144|NCT01439711|Secondary|Mean Total MRI Tumor Diameter Change From Baseline to Month 3|To ascertain the change in maximum tumor diameter from baseline to 3 months (D3) the same methods as in Primary outcome #1 will be used but on diameter instead of volume. For patients with more than one lesion longest diameter measurement, the sum of all lesion longest diameter measurements was calculated.|3-months||||millimeters||95% Confidence Interval|Mean
1382145|NCT01439711|Primary|Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6)|Mean total MRI FTV change from baseline to month 6 (V6): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V6 was calculated by subtracting the total MRI FTV measured at 6 months from the total MRI FTV measured at baseline. For V6 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.|up to 6 months from start of treatment||||cubic centimeters||95% Confidence Interval|Mean
1382146|NCT01439711|Primary|Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)|Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.|up to 3 months from start of treatment||||cubic centimeters||95% Confidence Interval|Mean
1382147|NCT01439672|Primary|Insulin Sensitivity|Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.|24 hours||||1/min per uU/mL||Standard Deviation|Mean
1382148|NCT01439581|Primary|Pressure Mapping Reducing Hospital Acquired Pressure Ulcers|Comparing number of pressure ulcers when using pressure mapping compared to when not.|Time admitted in the Medical Intensive Care Unit||||Participants|||Count of Participants
1382149|NCT01439373|Secondary|Mean Pre-dose Concentration and Concentration at 2 to 4 h Post-dose of GSK2336805 at Days 7, 14, 21, and 28|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters.|0 (pre-dose), 0 to 2 h, > 2 h up to 4 h, > 4 h up to 6 h, or > 6 h up to 10 h on Days 7, 14, 21 and 28|Sparse PK population included all participant who received GSK2336805, underwent sparse PK sampling during part 2 of the study, and provide at least one evaluable GSK2336805 PK concentration. Only those participants available at the specified time points were analyzed.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1382150|NCT01439373|Secondary|Mean Apparent Clearance (CL/F) of GSK2336805|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)|Intensive PK Population.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1382151|NCT01439373|Secondary|Mean Maximum Plasma Concentration of GSK2336805 (Cmax) and Concentration at 24 h (C24) at Day 1|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by non-compartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters.|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)|Intensive PK Population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1382152|NCT01439373|Secondary|Median Time of Maximal Plasma Concentration (Tmax) of GSK2336805 and Lag Time Before First Observation of Quantifiable Concentration (Tlag) at Day 1|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)|Intensive PK Population.|||h||Full Range|Median
1382153|NCT01439373|Secondary|Mean Area Under the Concentration-time Curve (AUC[0-24]), AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK2336805, at Day 1|AUC values were determined using the linear-up, log-down trapezoidal rule. The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were below quantification limit (BLQ) before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters.|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)|Intensive Pharmacokinetic (PK) Population comprised of all participants who received GSK2336805, undergo intensive PK sampling during part 1 (Day 1) of the study, and provide evaluable GSK2336805 PK parameters.|||Nanogram (ng)*h/mL||Geometric Coefficient of Variation|Geometric Mean
1382154|NCT01439373|Secondary|Median Serum Alanine Aminotransferase at Baseline, Day 7, 14, 21, 28 and 42|Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels.|Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42|Safety Population. Only those participants available at the specified time points were analyzed.|||U/L||Full Range|Median
1382155|NCT01439373|Secondary|Change From Baseline in Serum Alanine Aminotransferase Levels|Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value.|Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42|Safety population. Only those participants available at the specified time points were analyzed.|||Units per litre (U/L)||Standard Deviation|Mean
1382156|NCT01439373|Secondary|Mean Change From Baseline in Serum HCV RNA Levels at Day 2 and Day 28|Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test.|Baseline (Day 1, Pre -dose ) and Day 2 (24 h, post-dose), Day 28|Intent-to-Treat Exposed population. Only those participants available at the specified time points were analyzed.|||Log IU/mL||Standard Deviation|Mean
1382157|NCT01439373|Secondary|Mean Serum HCV RNA Levels at Baseline (Day 1), Day 2 and Day 28|Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test.|Baseline (Day 1, pre-dose), Day 2 (24 h, Post-dose) and Day 28|Intent-to-Treat Exposed population. Only those participants available at the specified time points were analyzed.|||Log IU/mL||Standard Deviation|Mean
1382158|NCT01439373|Secondary|Number of Participants With Vital Signs of Potential Clinical Concern|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 42 days|Safety population.|||Participants|||Count of Participants
1382159|NCT01439373|Secondary|Number of Participants With Shifts in Urinalysis Parameters From Normal at Baseline to Abnormal|The urinalysis parameters analyzed were Leukocyte esterase, bilirubin, occult blood, glucose, ketones, nitrite, pH, specific gravity and dipstick assessments. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at specified visit were reported. Visits where no abnormal values were observed not reported.|Day 14, 28, Follow-up (Day 42)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1382160|NCT01439373|Secondary|Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade for Serum Chemistry Parameters for Day 1 to Day 28|Abnormalities were graded according to the modified DAIDS version 1.0. Shift from Baseline to worst post Baseline toxicity grade were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Clinical chemistry parameters were alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatine phosphokinase, total CO2, chloride, creatinine, glucose, sodium, phosphate, potassium, total albumin, total bilirubin, and direct bilirubin. Only participants with change in toxicity grades are reported.|Baseline (Day 1) and 28|Safety population.|||Participants|||Count of Participants
1382161|NCT01439373|Secondary|Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade Hematology Parameters for Day 1 to Day 28|Laboratory abnormalities were graded according to the modified division of AIDS ( DAIDS）version 1.0. Shift from Baseline to worst post baseline toxicity grade (where applicable) were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Hematology parameters were red blood cell, hemoglobin, hematocrit, platelet white blood cell count with differential leukocyte count, mean corpuscular volume, prothrombin time and international normalized ratio.|Baseline (Day 1) to Day 28|Safety population.|||Participants|||Count of Participants
1382162|NCT01439373|Primary|Change From Baseline in QTcF Interval at Day 2 and 28|Single 12-lead electrocardiogram (ECG) was obtained. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. QTc Interval was calculated using Frederica correction formula: QTcF = QT / (RR)^1/3. Change from Baseline was calculated by subtracting the Baseline assessment value from post Baseline visit value. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. The change from Baseline in QTc Interval at Day 2 and 28 were reported.|Baseline (Day 1, Pre-dose ), Day 2 and Day 28|Safety population.|||msec||Standard Deviation|Mean
1382163|NCT01439373|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Day 28|Safety population was consisted of all participants who received at least 1 dose of study medication (GSK2336805 or matching placebo).|||Participants|||Count of Participants
1401855|NCT01249092|Primary|Change in Serum Alkaline Phosphatase Levels.|Serum alkaline phosphatase levels at entry and at 6 months of therapy with PTX will be measured and compared.|6 months||||U/L||Standard Deviation|Mean
1382164|NCT01439373|Primary|Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale|Blood samples for determination of HCV RNA levels were collected at immediately prior to and 1, 2, 4, 6, and 8 and 24 h after the first dose in Part 1 (Day 1). Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. Virus RNA levels reported as <43 are undetectable levels. If the result for HCV RNA (IU/ML) was <43, then change from Baseline was calculated using 42, and the change from Baseline on the log scale was calculated using log (42).|Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)|Intent-to-Treat Exposed population.|||Log IU/mL||Standard Deviation|Mean
1382165|NCT01439373|Primary|Number of Participants With HCV Genotype 1 With Virologic Response|Serum for determination of HCV genotype was collected at the screening visit. Genotype was determined by the VERSANT HCV genotype 2.0 Assay (LiPA). Number of participants with HCV genotype 1 were reported.|Day 7, 14 and 21|Intent-to-Treat Exposed population.|||Participants|||Count of Participants
1382166|NCT01439373|Primary|Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses|The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed was reported.|Day 28|Intent-to-Treat Exposed population.|||Posterior probability||Standard Deviation|Mean
1382167|NCT01439373|Primary|Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis|The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed by nominal analysis was reported.|Day 28|Intent-to-Treat Exposed population.|||Posterior probability||Standard Deviation|Mean
1382168|NCT01439373|Primary|Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses)|RVR was defined as the proportion of participants LOD <18 IU/mL for HCV RNA after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure. Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. The primary and supportive analysis differs from the nominal analysis as supportive analysis is assessed at Day 28 ± 2 (2 days visit window) whereas, the nominal analysis was assessed at Day 28.|Day 28|Intent-to-Treat Exposed population.|||Participants|||Count of Participants
1382169|NCT01439373|Primary|Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis|RVR was defined as the proportion of participants below the assay lower limit of detection (LOD) <18 International units per milliliter (IU/mL) for Hepatitis C virus (HCV) ribonucleic acid (RNA) after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure . Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants.|Day 28|Intent-to-Treat Exposed population comprised of all participants who meet study criteria and were randomly assigned to treatment in the study with documented evidence of had received at least 1 dose of randomized treatment and at least 1 post-baseline HCV RNA measurement.|||Participants|||Count of Participants
1382170|NCT01439360|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1382171|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1382172|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)|MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1382173|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1382174|NCT01439360|Secondary|Duration of Solicited General Symptoms|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Days||Full Range|Median
1392165|NCT01335932|Secondary|Number of Participants With CMV Reactivation at 28 Days in Plasma|Number of participants in baseline negatives with CMV reactivation at any level at day 28|at 28 days post-randomization||||Participants|||Count of Participants
1382175|NCT01439360|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Days||Full Range|Median
1382176|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Subjects|||Number
1382177|NCT01439360|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm.|During the 7-day (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Subjects|||Number
1382178|NCT01439360|Secondary|Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Day 0 and Day 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Subjects|||Number
1382179|NCT01439360|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).|"MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects."|At Day 28/56 (POST)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1382180|NCT01439360|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus.~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Day 28/56 (POST)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Subjects|||Number
1382181|NCT01439360|Secondary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects."|At Day 0 and Day 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Subjects|||Number
1382182|NCT01439360|Secondary|Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)|"Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Days 0 and 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1382183|NCT01439360|Secondary|Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382184|NCT01439360|Secondary|Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382185|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382186|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382187|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382188|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382189|NCT01439360|Secondary|Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382190|NCT01439360|Primary|Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382191|NCT01439360|Primary|Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Subjects|||Number
1382192|NCT01439282|Secondary|Number of Patients With Adverse Events of 4 Cycles of Eribulin Plus Capecitabine in the Adjuvant Setting|"Safety will be assessed by the monitoring and recording all AEs and serious adverse events (SAEs), regular monitoring of hematology and clinical chemistry, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status, regular physician assessments, concomitant medications, medical histories, and physical examinations.~Not posted. Treatment-emergent adverse events (TEAEs) and SAEs will be reported with the AEs and SAEs."|12 weeks|||||||
1382193|NCT01439282|Secondary|Use of Cold Cap for Alopecia|Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.|On the day of study drug infusion treatments during Cycles 1 through 4|Safety analysis set included all participants who received at least one dose of study treatments and had at least one postbaseline safety assessment.|||Participants|||Number
1382297|NCT01438307|Secondary|Progression Free Survival|Progression Free Survival is defined from the initiation of treatment until radiological-clinical evidence of progression according to the RECIST (v 1.1).|Baseline up to 28 months||||months||95% Confidence Interval|Median
1382194|NCT01439282|Primary|Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%|Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant’s body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.|21-Day Cycle 1 through 21-Day Cycle 4|Full analysis set included all participants who received at least one dose of eribulin mesylate plus capecitabine.|||Percentage of participants||95% Confidence Interval|Number
1382195|NCT01439204|Secondary|Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population|12-lead electrocardiograms were performed on a supine participant (5 minutes supine) at baseline (baseline = screening; Days -21 to -2) and at Day 71. QT interval and QTc were measured in mille seconds (msec). A change from baseline QT and QTc (corrected for heart rate by Fridericia formula) greater than (>) 30 msec or less than (<) 60 msec were presented, as well as values over 450 and 500 msec. QT interval on ECG image defined as: time from the beginning of the QRS (complex consisting of Q, R and S waves) to the end of the T wave.|Day 1 to Day 71|All participants who received study drug and had at least one ECG value.|||participants|||Number
1382196|NCT01439204|Secondary|Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had diastolic assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||mmHg||Standard Deviation|Mean
1382197|NCT01439204|Secondary|Change From Baseline in Systolic Blood Pressure - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had systolic assessment were included in the analysis. Days 1 and 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||mmHg||Standard Deviation|Mean
1382198|NCT01439204|Secondary|Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population|Blood samples obtained: Days 2, 4, 8, 15, 22, 29, 43, 57 and 71. Male(M); Female (F). Reference ranges (low/high) for laboratory parameters for which participants were identified with marked abnormalities during the study: Leukocytes (quantitative White blood cells) (M/F) 4-11*10^3/microliters (µL); Neutrophils (absolute)(M/F) 1.4- 8.2*10^3/µL.|Day 2 to Day 72|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||participants|||Number
1382199|NCT01439204|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population|Blood samples obtained: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71. International Units per liter (U/L); milligram per deciliter (mg/dL); Male(M); Female (F). Reference ranges (low/high) for laboratories for which participants were identified with marked abnormalities during the study: Blood Urea Nitrogen (M/F) 10-20mg/dL ; Creatine Kinase (F) 21-21 U/L,(M) 32-294 U/L; Direct Bilirubin (M/F) 0.1-0.4 mg/dL ; Fasting Glucose (M/F) 70-110 mg/dL; Lactate Dehydrogenase (M/F) 110-209 U/L.|Day 2 to Day 71|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||participants|||Number
1382200|NCT01439204|Secondary|Number of Participants With Positive Abatacept-induced Immunogenicity Response|Immunogenicity determination was based on titers of anti-abatacept and anti- cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4-T) antibodies in serum over time. A participant had a positive abatacept-induced immunogenicity if 1 of the following criteria were met: missing baseline measurement and a positive response after baseline; negative baseline response and positive response after baseline; a baseline response and a positive response after baseline that has a titer value strictly greater than the baseline titer value. A validated, sensitive, electrochemiluminescence assay (ECL) method was used to analyze the antibodies in serum. Samples confirmed positive with ECL and with abatacept serum concentrations of less than equal to 1 µg/mL were further analyzed with a validated, in vitro, cell-based bioassay to analyze the sera containing the abatacept neutralizing activity. Samples obtained on Days 29, 57 and 71 post dose of abatacept on Day 1 (baseline).|Days 29, 57, 71|Immunogenicity Data Set: All participants with at least 1 postdose visit.|||participants|||Number
1382201|NCT01439204|Primary|Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Vss was measured in liters per kg body weight (L/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
1382298|NCT01438307|Primary|Objective Response Rate|The objective response is defined as the percentage of patients that achieve a complete and/or partial response according to The Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).|Baseline up to 28 months||||participants|||Number
1382202|NCT01439204|Primary|Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1382203|NCT01439204|Primary|Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). T-HALF was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||h||Standard Deviation|Mean
1382204|NCT01439204|Primary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - INF) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - INF) was measured in µg*h/mL.|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1382205|NCT01439204|Primary|Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - T) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - T) was measured in micro grams*hour per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1382206|NCT01439204|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - 28) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - 28) was measured in micro grams*hours per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1382207|NCT01439204|Primary|Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Tmax was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||h||Full Range|Median
1382208|NCT01439204|Primary|Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).|Days 1 to 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles. All completers had evaluable PK.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1382209|NCT01439165|Secondary|Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions|Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, >100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1382210|NCT01439165|Primary|Percentage of Subjects With Pertussis Antigen Booster Response|"Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin [FHA], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value.~Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens."|1 month post-booster vaccination|Booster response rate was assessed in the Per protocol analysis set|||Percentage of subjects|||Number
1382321|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months||||mmHg||Standard Deviation|Mean
1382211|NCT01439165|Primary|Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies|Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens.|1 month post-booster vaccination|Geometric mean concentrations were assessed in the Per Protocol Analysis Set.|||Concentrations (1/dil)||95% Confidence Interval|Geometric Mean
1382212|NCT01439165|Primary|Percentage of Participants With Diphtheria and Tetanus Booster Response|Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were > 2.56 IU/mL for diphtheria and > 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response.|1 month post-booster vaccination|Booster response rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1382213|NCT01439165|Primary|Percentage of Participants With Diphtheria and Tetanus Seroprotection|Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.|1 month post-booster vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1382214|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Changes in the Columbia Suicide Severity Rating Scale (C-SSRS)|"The outcome reported is the number of subjects that responded Yes to the question “Do you have a wish to be dead” at Visit 20.~C-SSRS is a clinician-rated instrument designed to provide consistent and systematic assessment of both suicidal ideation and behavior within a study, as well as across studies. The scale is a feasible, low burden series of questions that appropriately assess and track all suicidal events, including ideation. Suicidal ideation is assessed according to yes/no responses to 5 questions of increasing severity (from a wish to die to an active thought of killing oneself with plan and intent) as follows:~Wish to be Dead~Non-Specific Active Suicidal Thoughts~Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Active Suicidal Ideation with Specific Plan and Intent"|Visit 20 (Week 40)|Double-Blind Full Analysis Set|||participants|||Number
1382215|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs||From study start to study end (40 weeks)|Double-Blind Full Analysis Set|||Participants|||Number
1382216|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Epworth Sleepiness Scale for Children (ESS-C)|"Change in the ESS-C scale from randomization to end of randomized-withdrawal period. The ESS-C is a simple eight-tem Likert scale designed to assess daytime sleepiness in children aged 2-18 years. The scale takes less than two minutes to be completed by patient or by parent rating. Sleepiness is a common symptom in both medicated and unmedicated children with ADHD given the predominance of impaired sleep quality. The total score achieved when the chance of dozing in each situation is added up serves as the outcome measure.~The ESS-C comprises 8 items describing various daytime activities. Item scores ranging from 0 (“would never doze or sleep”) to 3 (“high chance of dozing or sleeping”). A total score is derived as the sum of the items, with higher total scores indicative of a greater level of sleepiness (worse outcome). Total scores range from 0 to 24."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||units on a scale||Standard Deviation|Mean
1382217|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P)|"The WFIRS-P is designed to assess the impact of child’s behavior or emotional problems on 7 domains related to function: Family (10 items), School Learning (4 items), School Behavior (6 items), Life Skills (10 items), Child’s Self-concept (3 items), Social Activities (7 items), and Risky Activities (10 items). Each item was scored on a scale ranging from 0 (“never or not at all”) to 3 (“very often or very much”). Each scale score was calculated as the average for that scale. The total score is the average of all non-missing items. Higher scores are associated with greater impact of disease on functioning."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||units on a scale||Standard Deviation|Mean
1382218|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Clinical Global Impressions-Severity of Illness Scale (CGI-S)|"The CGI-S is a clinician rated instrument designed to assess the subject’s current illness state. The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||scores on a scale||Standard Deviation|Mean
1382237|NCT01438840|Primary|Number of Weeks With Platelet Count Greater Than or Equal to 50 x 10^9/L During 6-Month Treatment Period|The cumulative number of weeks of platelet response is defined as the total numbers of weeks in which the platelet count is greater than or equal to 50 x 10^ 9/L during 6 months of treatment of core study in the absence of rescue therapy.|Week 1 to Week 26|Full Analysis Set (Core Study): All participants who were randomized into the study.|||Weeks||Full Range|Median
1382238|NCT01438814|Secondary|Change From Baseline in HbA1c Over Time|Means are adjusted by treatment and continuous baseline HbA1c|Baseline, 2 weeks and 8 weeks|Patients from FAS1000 (LOCF)|||percent||Standard Error|Mean
1382219|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the ADHD-Rating Scale-4th Edition (ADHD-RS-IV)|The ADHD-RS-IV (clinician version), has been widely used as a measure of efficacy in clinical trials of treatments in children and adolescents with ADHD. It is derived from the 18 inattentive and hyperactive/impulsive diagnostic criteria for ADHD from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). The clinician version of the ADHD-RS-IV has a large base of normative data and has demonstrated reliability and discriminant validity in children and adolescents. The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse and a lower score more favourable). Two subscales are summed.|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||scores on a scale||Standard Deviation|Mean
1382220|NCT01439126|Secondary|To Evaluate the Long-term Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Time to Treatment Failure From the Start of Randomized-withdrawal Period|Time to treatment failure was calculated as follows: Treatment failure (not premature termination) = visit date where the failure criteria was met – visit 9 date + 1; Treatment failure (premature termination) = termination date – visit 9 date + 1|Time From randomization to treatment failure (up to 26 weeks)|Double-Blind Full Analysis Set|||days||95% Confidence Interval|Median
1382221|NCT01439126|Primary|Long-term Maintenance of Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Percentage of Treatment Failures in the KAPVAY vs. Placebo Groups|"Treatment failure a ≥30 percentage increase (worsening)(ADHD-RS-IV, clinician version) total score and a ≥2 point increase (worsening) in Clinical Global Impressions-Severity of Illness Scale (CGI-S) at any two consecutive visits during the randomized-withdrawal period.~The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse).~The CGI-S is a 7-point scale,1 (Normal, not at all ill) to 7 (extremely ill patients).The CGI-Severity (CGI-S) asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set. This set included all randomized subjects who took at least 1 dose of study medication during the double blind (randomized-withdrawal) phase|||% of Participants|||Number
1382222|NCT01439074|Secondary|% of Study Burn Healed After One Week||1 week||||percentage of study burn healed||Standard Deviation|Mean
1382223|NCT01439074|Secondary|Number of Dressing Changes|Number of dressing changes including first assembly|4 weeks|ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.|||applications||Standard Deviation|Mean
1382224|NCT01439074|Secondary|Percent of Burn Epithelised/Healed|Healing will be defined as 95% or more epithelialisation|4 weeks||||percentage of study burn healed||Standard Deviation|Mean
1382225|NCT01439074|Primary|Time to Healing|Healing will be defined as number of days|4 weeks|ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.|||days||Standard Deviation|Mean
1382226|NCT01438996|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 28-day period after vaccination||||participants|||Number
1382227|NCT01438996|Secondary|Number of Subjects Reporting AE|AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)|During the 28-day period after vaccination||||participants|||Number
1382228|NCT01438996|Secondary|Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.|During the 7-day period after vaccination||||participants|||Number
1382229|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 28 days after vaccination as compared to baseline||||percentage of subjects||95% Confidence Interval|Number
1382230|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 7 days after vaccination as compared to baseline||||percentage of subjects||95% Confidence Interval|Number
1382231|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 3 days after vaccination as compared to baseline||||percentage of subjects||95% Confidence Interval|Number
1382232|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA|At 28 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1382233|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA|At 7 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1382234|NCT01438996|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)|At 3 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1382235|NCT01438840|Secondary|Number of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Day 8|Participants with platelet response at Day 8 are defined as those who had a platelet count greater than or equal to 50 x 10^9/L at day 8 in the absence of rescue therapy on or before Day 8.|Week 1 (Day 8)|Full Analysis Set (Core Study): All participants who were randomized into the study.|||Participants|||Count of Participants
1382236|NCT01438840|Secondary|Number of Participants With a Reduction in Use of Concomitant Immune/Idiopathic Thrombocytopenic Purpura (ITP) Medication|Only participants on concomitant ITP medications at baseline were included.|Week 1 through Week 26|Full Analysis Set (Core Study): All participants who were randomized into the study.|||Participants|||Count of Participants
1382239|NCT01438814|Secondary|Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)|||participants|||Number
1382240|NCT01438814|Secondary|Change From Baseline in Body Weight by Visit at Week 14|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight|Baseline and 14 weeks|FAS1000 having values for weight at baseline and week 14.|||kg||Standard Error|Mean
1382241|NCT01438814|Secondary|Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)|||participants|||Number
1382242|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment).|14 weeks|Patients from the FAS1000 (NCF)|||participants|||Number
1382243|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)|||participants|||Number
1382244|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF) having a baseline HbA1c>=6.5%.|||participants|||Number
1382245|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment|The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c.|14 weeks|Patients from the FAS1000 using original results (OR) and having GI adverse events which were assessed for severity by the patient.|||units on a scale||Standard Error|Mean
1382246|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment|Patients could experience multiple events, therefore, multiple answers were possible for each patient.|14 weeks|Patients from FAS1000 and having GI adverse events which were assessed for severity by the investigator.|||events|Participants||Number
1382247|NCT01438814|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 14 weeks|Patients from FAS1000 with LOCF|||mg/dL||Standard Error|Mean
1382248|NCT01438814|Secondary|Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment|Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks|14 weeks|Patients from FAS1000|||participants|||Number
1382249|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment)|14 weeks|Patients from FAS1000 with non-completer considered as failure (NCF) having a baseline HbA1c>=7.0%.|||participants|||Number
1382250|NCT01438814|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment|Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c.|Baseline and 14 weeks|FAS1000mg with last observation carried forward (LOCF): all patients randomised and treated who had a baseline at least 1 on-treatment HbA1c value and who tolerated a daily metformin dose of at least 1000 mg at the end of the titration phase.|||percent||Standard Error|Mean
1382251|NCT01438710|Primary|Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.|"The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion.~The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor.~Below the mean total score and standard deviation for each treatment is given in addition to the mean change."|14 days|"Of the 40 patients who completed the study period, 38 patients were evaluable for efficacy evaluation and included in the modified intention to treat (mITT) population.~The outcome measure is given as total score below."|||units on a scale||Standard Deviation|Mean
1382252|NCT01438541|Secondary|Evaluate the Dressing Shape|Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent|14 days||||participants|||Number
1382253|NCT01438541|Secondary|Overall Experience of Use of the Dressing|Investigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured|14 days||||participants|||Number
1382254|NCT01438541|Primary|Erythema ( No/Yes)|Total improvement of erythema|14 days|Vulnerable subjects with high risk of skin breakdown.|||participants|||Number
1382280|NCT01438424|Secondary|Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay||Baseline to Week 144|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382255|NCT01438489|Secondary|Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365|Accumulation ratio for trough concentration (Ctrough,AR) of anifrolumab after multiple administration at Day 169 and 365 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||Ratio||Full Range|Median
1382256|NCT01438489|Secondary|Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365|Trough concentration (Ctrough) of anifrolumab at Day 29, 169 and 365 were calculated.|Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||microgram per milliliter||Standard Deviation|Mean
1382257|NCT01438489|Secondary|Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab|Accumulation ratio for maximum plasma concentration (Cmax,AR) of anifrolumab after multiple administration at Day 169 and 337 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||Ratio||Full Range|Median
1382258|NCT01438489|Secondary|Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337|Maximum plasma concentration (Cmax) was defined as the peak plasma level of anifrolumab, derived from plasma concentration ­time data.|Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
1382259|NCT01438489|Secondary|Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature|The PD positive and negative gene signature was determined by comparing the expression of type I IFN-inducible genes in a 21-gene panel in study participants relative to pooled normal blood collected from healthy participants.|Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||Ratio||Standard Deviation|Mean
1382260|NCT01438489|Secondary|Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)|Anti-drug antibody responses to anifrolumab in serum were evaluated.|Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)|"The safety population included participants who received any investigational product. Here, N and “n” signifies evaluable participants for this outcome measure and for specified category of the arms respectively. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in Anifrolumab 1000 mg group."|||Percentage of Participants|||Number
1382261|NCT01438489|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant changes from the screening ECG was recorded as TEAEs. An abnormal ECG findings such as QT prolonged were reported as treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
1382262|NCT01438489|Secondary|Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign parameters are temperature, blood pressure, respiratory rate, heart rate and weight. Vital signs abnormalities were reported as TEAEs.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
1382263|NCT01438489|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events|Any medically significant change in laboratory evaluations were recorded as Treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
1382264|NCT01438489|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A serious AE (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly (in offspring of participant). AEs may be treatment emergent (TE) [that is, occurring after initial receipt of investigational product] or non-TE. An AESI is one of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by investigator to sponsor.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
1382293|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382265|NCT01438489|Secondary|Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365|Participants on OCS >=10 mg/day of prednisone or equivalent at baseline who were able to taper to <= 7.5 mg/day at Day 365 were evaluated.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
1382266|NCT01438489|Secondary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365|An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the MDGA (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 281 through Day 365 (less than 10 mg/day and less or equal to the dose received on Day 1). SRI was analyzed by a logistic regression model.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
1382267|NCT01438489|Primary|Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169|Type I IFN signature in whole blood assessed by using a 4-gene diagnostic test. The blood samples collected were to be used to prospectively identify participants as IFN test-high or test-low. The results of this test were used to stratify participants. An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 mg/day and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
1382268|NCT01438489|Primary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169|An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index ‘A’ organ system score and no more than one new or worsening BILAG-2004 Index ‘B’ organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The modified Intent-To-Treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
1382269|NCT01438424|Secondary|Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and had serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)|||Log10 copies/mL||Standard Error|Mean
1382270|NCT01438424|Secondary|Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR Assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. ULN=upper limit of normal.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)|||Percentage of participants|||Number
1382271|NCT01438424|Primary|Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal.|End of dosing to Week 48 off-treatment follow-up|Participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.|||Percentage of participants|||Number
1392166|NCT01335932|Primary|Serum IL-6 Level|Change between baseline and 14 days post-randomization between placebo & ganciclovir groups|Baseline and Day 14||||pg/mL||Standard Deviation|Mean
1382272|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from study AI463-027 who were nucleoside-naive HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382273|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-027 who were nucleoside-naive HBeAg-negative, received lamivudine, and had >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382274|NCT01438424|Primary|Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 192|Participants who enrolled from Phase 3 studies of nucleoside-naive HBeAg-positive (AI463-022) and HBeAg-negative (AI463-027) participants and received at least 1 dose of study drug in the current study up to Week 192. (n=number of evaluable participants)|||Participants|||Number
1382275|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382276|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382277|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort)|The Entecavir Retreatment Cohort consisted of participants who were nucleoside-naive, HBeAg-negative and enrolled from BMS study AI463-027 with >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as retreatment in the current study.|Baseline to Weeks 48, 96, and 144|Participants enrolled from study AI463-027 who were nucleoside-naive, HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382278|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort)|The Entecavir Continuous Treatment Cohort consisted of participants from study AI463-022 (NCT00035633) who were nucleoside-naive HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current. This cohort is considered to be on continuous entecavir treatment and permitted assessment of continuous administration of entecavir in AI463-022 and the current study.|Baseline to Weeks 48, 96, 144, 192, and 240|Participants enrolled from study AI463-022 who were nucleoside-naive, HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current study and were evaluable. (n=number of evaluable participants)|||Percentage of participants|||Number
1382279|NCT01438424|Primary|Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 144|Participants enrolled up to Week 144 who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
1392167|NCT01335867|Secondary|Depression and Anxiety|Measures of depression and anxiety will be assessed using the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale|8 weeks|||||||
1382281|NCT01438424|Primary|Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing|Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-<90; Gr 3=80-<85; Gr 4=40-<80. Hyperchloremia: Gr 1=113-<117; Gr 2=117-<121; Gr 3=121-125; Gr 4>125. Hypocarbia: Gr 1=19-21; Gr 2=15-<19; Gr 3=41-45; Gr 4=>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=>45. Hyponatremia: Gr 1=130-132; Gr 2=123-<130; Gr 3=116-<123; Gr 4<116. Hypernatremia: Gr 1=148-<151; Gr 2=151-<158; Gr 3=158-165; Gr 4=>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-<3; Gr 3=2-<2.5; Gr 4=<2. Hyperkalemia: Gr 1=5.6-<6.1; G2=6.1-<6.6; Gr 3=6.6-7; Gr 4=>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-<55; Gr 3=30-< 40; G4=-<30. Hyperglycemia: Gr 1=116-<161; Gr 2=161-<251; Gr 3=251-500; Gr 4>500.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
1382282|NCT01438424|Primary|Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing|Amylase: Grade 1=1.10-<1.40*ULN; Grade 2=1.40-< 2.10*ULN; Grade 3=2.10-5.00*ULN; Grade 4=>5.00*ULN. Lipase: Grade 1.1-<1.4*ULN; Grade 2=1.4-<2.1*ULN; Grade 3=2.1-5.0*ULN; Grade 4=>5.0*ULN. Creatinine: Grade 1=1.10-< 1.60*ULN; Grade 2=1.60-<3.10*ULN; Grade 3=3.10-6.00*ULN; Grade 4=>6.00*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-<2.60*ULN; Grade 2=2.60-<5.10*ULN; Grade 3=5.10-10*ULN; Grade 4=>10*ULN. ULN=upper limit of normal.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
1382283|NCT01438424|Primary|Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240|Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-<9.5; Gr 3=6.5-<8.0; Gr 4=<6.5 White blood cells (cells/mm^3): Gr 1=2,500-<4,000; Gr 2=1,000-<2,500; Gr 3=800-<1,000; Gr 4=<800. Neutrophils (cells/mm^3): Gr 1=1000-<1500; Gr 2=750-<1000; Gr 3=500-<750; Gr 4=<500. Platelets (cells/mm^3): Gr 1=75,000-99,000; Gr 2=50,000-<75,000; Gr 3=20,000-<50,000; Gr 4=<20,000. Prothrombin time (seconds): Gr 1=1.01-<1.26*ULN; Gr 2=1.26-<1.51 *ULN; Gr 3=1.51-3*ULN; Gr 4=>3*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=>3. INR=international normalized ratio; ULN=upper limit of normal. .|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
1382284|NCT01438424|Secondary|Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)|The Ishak Modification for Hepatic Activity Index (HAI) scores necroinflammatory activity in chronic hepatitis. 0=no fibrosis, 1=fibrosis expansion of some portal areas, 2=fibrosis expansion of most portal areas, 3=fibrosis expansion of most portal areas with occasional bridging, 4=fibrosis expansion of portal areas with marked bridging, 5=incomplete cirrhosis, 6=probable or definite cirrhosis. Higher score=more severe necrosis. Improvement in fibrosis=≥1-point reduction in HAI score. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)|||Percentage of participants||95% Confidence Interval|Number
1382285|NCT01438424|Secondary|Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)|The Knodell Histologic Activity Index scores stage of necrosis and grade of inflammation in liver biopsies. Components are necrosis near the portal vein, intralobular degeneration and focal necrosis, portal inflammation, and fibrosis. The 4 components are scored from 1 to 4 and 1 to 10 (necrosis near the portal vein) and combined for a total score, with 22 being the highest possible score. Higher the score for each component=greater liver damage. Histologic improvement=a ≥2-point reduction in total Knodell score and no worsening in fibrosis. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell necroinflammatory scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)|||Percentage of participants||95% Confidence Interval|Number
1382286|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved ALT Normalization|ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0*ULN.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382287|NCT01438424|Secondary|Overall Study: Mean Alanine Transaminase (ALT) Levels|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||U/L||Standard Deviation|Mean
1382288|NCT01438424|Secondary|Overall Study: Percentage of Participants With HBeAg Seroconversion|Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382289|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382290|NCT01438424|Secondary|Overall Study: Mean HBV DNA Level by PCR Assay||Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||log10 copies/mL||Standard Deviation|Mean
1382291|NCT01438424|Primary|Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal.|Continuously from Day 1 through Week 240|All participants who received at least 1 dose of study drug in the current study.|||Participants|||Number
1382292|NCT01438424|Secondary|Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay|Observed values.|Baseline to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
1382299|NCT01438294|Other Pre-specified|Energy Expenditure|Was measured using a biaxial accelerometer (SenseWearTM Pro activity monitor, USA) (Kuys et al. 2011). The equipment was always used on the upper right limb for the determination of skin temperature, galvanic skin response and movement. Energy expenditure was calculated in metabolic equivalents (METS) and calories per minute. The SenseWear arm bandTM was used during the exercise sessions as a comparative parameter of effort intensity in the VGG and TG. The energy expenditure at rest, medium and maximum effort was the average of all sessions of all children.|baseline and during all training sessions 8 weeks|||||||
1382300|NCT01438294|Other Pre-specified|Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease|"Asthma control questionnaire (ACQ) is a standardized toll to assess clinical control in asthmatic patients and consists of 7 questions, 5 related to asthma symptoms, one regarding the use of short- acting ß2 agonists as rescue medication, and one regarding FEV1 before bronchodilator in percent of predicted.~ACQ score is the average these items and ranges from 0 (completely controlled) to 6 (uncontrolled) obtained in a 7 days period. The total points is divided by six to provide the final score ( six questions with range 0 to 6 points, maximal 36 points divided by six maximal 6 and mimimal 0)~The cutoff point for controlled/uncontrolled asthma is 2 points. Patient was classified according ACQ scores into controlled (<0.75), partially controlled (0.75-1.5) and uncontrolled asthma (>1.5). A minimal clinical important difference is 0.5 on a 7-point scale (Juniper et al.2005, Leite et al. 2008 and Ko et al. 2012)."|clinical control week 8||||units on a scale||Inter-Quartile Range|Median
1382301|NCT01438294|Secondary|Pulmonary Function|was performed before and after the inhalation of 400μg of salbutamol (Easy One™, USA), and technical procedures were performed as recommended by ATS/ERS. Predicted normal values were those proposed by Polgar and Promadhat 1971 and a 12% and 200 mL increase in FEV1 from baseline were characterized as a positive response to the bronchodilator) in a climate-controlled room.|baseline and after 8 weeks|||||||
1382302|NCT01438294|Secondary|Body Composition|All participants were evaluated individually, always during the afternoon to avoid circadian changes. Height, weight and abdominal circumference were determined. Tetrapolar bioimpedance was measured using the Biodynamics™ model 310 (Biodynamics Corporation Seattle WA, USA) by positioning the child in the supine position and electrodes in the extremity of the right upper and lower limbs (Goran et al.1993).|baseline and after 8 weeks|||||||
1382303|NCT01438294|Secondary|Treadmil Test (Bruce Protocol)|"A maximal exercise testing was performed in a treadmill using Bruce protocol that has been used to provide information on exercise capacity, physiopathological characteristics during effort, the efficacy of medications and the potential risk for diseases ( Zijp et al. 2010). The test was interrupted when the child reported maximal fatigue or reached the maximum heart rate around 200bpm (Peyer et al. 2011). During the test, blood pressure and peripheral oxygen saturation were quantified and an electrocardiogram was performed. The Borg scale was used to quantify for the sensation of shortness of breath during effort and at rest (Lamb 1995).~Change from baseline in the distance walked on treadmill test will be consider as outcome measure."|8 week distance walked on treadmill test||||meters||Standard Deviation|Mean
1382304|NCT01438294|Primary|Exhaled Nitric Oxide (FeNO) Level|"The measurement of exhaled FeNO level is performed by several commercially available devices, however the equipment NIOX ® (Aerocrine, Sweden) analyzer is the only FDA-approved and Anvisa (Food and Drug Administration) for clinical monitoring of asthma.~The measure will be performed before and after the training program of exercise, or pulmonary rehabilitation, by means of portable equipment NIOX MINO ®."|The FeNO level was performed in week 8||||ppb||Standard Deviation|Mean
1382305|NCT01438229|Other Pre-specified|Cystatin C||24 months||||mg/L||Standard Deviation|Mean
1382306|NCT01438229|Other Pre-specified|Cystatin C||18 months||||mg/L||Standard Deviation|Mean
1382307|NCT01438229|Other Pre-specified|Cystatin C||12 months||||mg/L||Standard Deviation|Mean
1382308|NCT01438229|Other Pre-specified|Cystatin C||6 months||||mg/L||Standard Deviation|Mean
1382309|NCT01438229|Other Pre-specified|Cystatin C||Baseline||||mg/L||Standard Deviation|Mean
1382310|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|24 months||||mL/min per 1.73m^2||Standard Deviation|Mean
1382311|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|18 months||||mL/min per 1.73m^2||Standard Deviation|Mean
1382312|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|12 months||||mL/min per 1.73m^2||Standard Deviation|Mean
1382313|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|6 months||||mL/min per 1.73m^2||Standard Deviation|Mean
1382314|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|Baseline||||mL/min per 1.73m^2||Standard Deviation|Mean
1382315|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||24 months||||mg/g||Standard Deviation|Mean
1382316|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||18 months||||mg/g||Standard Deviation|Mean
1382317|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||12 months||||mg/g||Standard Deviation|Mean
1382318|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||6 months||||mg/g||Standard Deviation|Mean
1382319|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||Baseline||||mg/g||Standard Deviation|Mean
1382320|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months||||mmHg||Standard Deviation|Mean
1392168|NCT01335867|Secondary|Alcohol and Cocaine Withdrawal Severity|Measures of alcohol and cocaine withdrawal severity will include Clinical Institutes Withdrawal Scale for Alcohol and Cocaine Selective Severity Assessment|8 weeks|||||||
1382322|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months||||mmHg||Standard Deviation|Mean
1382323|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months||||mmHg||Standard Deviation|Mean
1382324|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months||||mmHg||Standard Deviation|Mean
1382325|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months||||mmHg||Standard Deviation|Mean
1382326|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 24 months||||mmHg||Standard Deviation|Mean
1382327|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 18 months||||mmHg||Standard Deviation|Mean
1382328|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 12 months||||mmHg||Standard Deviation|Mean
1382329|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 24 months||||mmHg||Standard Deviation|Mean
1382330|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 18 months||||mmHg||Standard Deviation|Mean
1382331|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 12M||||mmHg||Standard Deviation|Mean
1382332|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 6M||||mmHg||Standard Deviation|Mean
1382333|NCT01438229|Primary|Office Systolic Blood Pressure Change||Baseline to 6 months|Subjects with both baseline and 6M follow up office blood pressure measurements|||mmHg||Standard Deviation|Mean
1382334|NCT01438229|Primary|Adverse Events|All device or procedure related adverse events|24 months|All subjects receiving renal artery ablation procedure|||percentage of participants|||Number
1382335|NCT01438177|Secondary|Median Duration of Response of This Regimen|Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).|up to 2 years|patients who have responded|||months||Full Range|Median
1382336|NCT01438177|Secondary|Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy||until clinical response (up to 2 years)|||||||
1382337|NCT01438177|Secondary|Number of Participants With Adverse Events of Grade 3 or Higher|Adverse events reported here were at least possibly related to the protocol therapy.|Treatment period plus 30 days post-treatment|Any patients who started the treatment|||participants|||Number
1382338|NCT01438177|Primary|Response Rate (CR + PR After 2 Cycles)|"Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:~CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h"|Up to 2 years|Evaluable patients.|||percentage of participants|||Number
1382339|NCT01438151|Primary|Remicade Dose Escalation|At visit 1 and 2, Remicade given at 5mg/kg. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.|2/16/12-3/22/13||||participants|||Number
1382340|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 140 to Week 328|Participants in France who completed the 130-week open-label extension phase and continued beyond Week 140 were included in safety sample.|||Participants|||Number
1382341|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.|||Participants|||Number
1382342|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.|||Participants|||Number
1382410|NCT01437501|Secondary|Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)|Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.|Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])||||micromoles||Inter-Quartile Range|Median
1382343|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.|||Participants|||Number
1382344|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.|||Participants|||Number
1382345|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.|||Participants|||Number
1382346|NCT01438060|Secondary|Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||units on a scale||Standard Error|Mean
1382347|NCT01438060|Secondary|Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on Scale||Standard Error|Mean
1382348|NCT01438060|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase|"AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on Scale||Standard Error|Mean
1382349|NCT01438060|Secondary|Clinical Global Impression (CGI) Improvement Score During Extension Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on Scale||Standard Error|Mean
1382350|NCT01438060|Secondary|Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values~Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on a Scale||Standard Error|Mean
1382394|NCT01437878|Secondary|Change in Oxygen Uptake|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382351|NCT01438060|Secondary|Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants who were evaluated for electrocardiogram|||Participants|||Number
1382352|NCT01438060|Secondary|Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for vital signs|||Participants|||Number
1382353|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline.|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for laboratory findings|||Participants|||Number
1382354|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.|||Participants|||Number
1382355|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.|||Participants|||Number
1382356|NCT01438060|Secondary|Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"Observed cases data set, efficacy sample. n=Participants with both post-baseline and baseline measures.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Unit on scale||95% Confidence Interval|Mean
1382357|NCT01438060|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase|"The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0–4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|Baseline (Day 0), Weeks 2, 4, 8, and 10|"Observed Cased data set, efficacy sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on scale||95% Confidence Interval|Mean
1382358|NCT01438060|Secondary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline (Day 0), Weeks 2, 4, and 10|"Observed cases data set, Efficacy Sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on scale||95% Confidence Interval|Mean
1382395|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Oxygen|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382359|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382360|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382361|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382362|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382363|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382364|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382365|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382411|NCT01437501|Primary|Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period|Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks|Endpoints were assessed on urine samples collected at the end of the intervention on week 12.|Analyses were conducted on all urine samples provided by study participants at week 12.|||pmol/mg creatinine||Inter-Quartile Range|Median
1382366|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382367|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382368|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382369|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382370|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382371|NCT01438060|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline (Day 0), Week 10|"LOCF data set, efficacy sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on Scale||Standard Error|Mean
1382372|NCT01438060|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase|"The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.~A negative change score signifies improvement."|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Unit on Scale||95% Confidence Interval|Mean
1382396|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Carbon Dioxide|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382373|NCT01438060|Secondary|CGI Improvement Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on Scale||Standard Error|Mean
1382374|NCT01438060|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2). An additional participant did not have CGI-Severity score and was not included in the analysis"|||Units on Scale||95% Confidence Interval|Mean
1382375|NCT01438060|Secondary|Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382376|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Unit on a Scale||95% Confidence Interval|Mean
1382377|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Participants|||Number
1382378|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Participants|||Number
1382379|NCT01438060|Secondary|Change From Baseline in NPI Total Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
1382397|NCT01437878|Secondary|Change in Pulmonary Vascular Resistance|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382380|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on Scale||95% Confidence Interval|Mean
1382381|NCT01438060|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Week 10|"Last Observation Carried forward (LOCF) data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a scale||Standard Error|Mean
1382382|NCT01437995|Secondary|Pulmonary Function: Change in FEV1/FVC Ratio|Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.|Baseline and 48 weeks||||ratio||95% Confidence Interval|Median
1382383|NCT01437995|Secondary|Change in Pulmonary Function: FEV1 and FVC|Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.|Baseline and 48 weeks||||Liters||95% Confidence Interval|Median
1382384|NCT01437995|Secondary|Rate of Episodes of Poor Asthma Control|Rate of episodes of poor asthma control (EPAC) defined by unscheduled medical care, hospitalization, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate|48 weeks||||Episodes of poor asthma control|||Number
1382385|NCT01437995|Secondary|Pulmonary Function- Change in Peak Expiratory Flow|Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)|Baseline and 48 weeks||||Liters per minute||95% Confidence Interval|Median
1382386|NCT01437995|Primary|Treatment Failure|Rate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.|48 weeks||||participants|||Number
1382387|NCT01437943|Primary|Effect of Aliskiren on Kidney Metabolism|Evaluation of aliskiren on kidney metabolism by P-MR spectroscopy|180 days (completion of treatment)|Only one subject completed study drug and no subjects had completed the 6 month P-MR scan at the time the trial was terminated. Because of this, we were not able to analyze the primary outcome.||||||
1382388|NCT01437878|Secondary|Change in Minute Ventilation|Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382389|NCT01437878|Secondary|Change in Tidal Volume|Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382390|NCT01437878|Secondary|Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry|Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382391|NCT01437878|Secondary|Change in Heart Rate|Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382392|NCT01437878|Secondary|Change in Oxygen Uptake Per Heartbeat|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382393|NCT01437878|Secondary|Change in Carbon Dioxide Output|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382412|NCT01437488|Secondary|Number of Participants Who Tolerated Cabazitaxel||Up to 30 days after completion of study treatment||||Participants|||Count of Participants
1382398|NCT01437878|Secondary|Change in Right Ventricular Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382399|NCT01437878|Secondary|Change in Cardiac Output|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382400|NCT01437878|Secondary|Change in Mean Right Atrial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382401|NCT01437878|Secondary|Change in Mean Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382402|NCT01437878|Secondary|Change in Diastolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382403|NCT01437878|Secondary|Change in Systolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382404|NCT01437878|Secondary|Participants With Treatment-emergent Adverse Events|Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks|Baseline up to 24 hours post-EOT, approximately 4 weeks|Total population|||participants|||Number
1382405|NCT01437878|Primary|Change in Endurance Time|Change from baseline to week 4 in endurance time during constant work rate exercise testing|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
1382406|NCT01437540|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline|Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)|Up to study Week 56 ± 3 days|Patients with baseline and at least 1 post-baseline assessment value for each parameter|||Percentage of patients|||Number
1382407|NCT01437540|Secondary|Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure|Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline|Up to study Week 56 ± 3 days|Patients with baseline and at least 1 post-baseline assessment of vital signs for each parameter|||Percentage of patients|||Number
1382408|NCT01437540|Secondary|Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study|"<0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts~>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride~Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN"|Up to study Week 52|Patients with available non-potentially clinically significant baseline value and at least one post-baseline assessment|||Percentage of participants|||Number
1382409|NCT01437540|Primary|Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)|TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)|Up to study Week 56 ± 3 days|Safety Population defined as all randomized patients who took at least one dose of double-blind investigational product|||Percentage of participants|||Number
1382429|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set|||percentage of subjects||95% Confidence Interval|Number
1382413|NCT01437488|Secondary|Progression Free Survival|To determine the progression free survival (PFS) of patients with advanced or recurrent urothelial carcinoma who have previously been treated with a platinum based regimen while on treatment with cabazitaxel. Defined as a 20% increase in the largest diameter of the largest lesion by CT scan.|Every 3 cycles or 63 days||||Participants|||Count of Participants
1382414|NCT01437488|Secondary|Overall Survival|To determine the percentage of patients alive at 12 months from trial entry. Overall survival will be measured from date of randomization to date of death due to any cause.|At 12 months||||Participants|||Count of Participants
1382415|NCT01437488|Primary|Overall Response Rate|To determine the overall response rate of patients who have disease response while on treatment with Cabazitaxel. CT scan will be used to measure tumor pre-treatment and then every 3 cycles (every 63 days)|Every 3 cycles or 63 days||||Participants|||Count of Participants
1382416|NCT01437423|Other Pre-specified|Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.|The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported.|Up to 30 days post-primary and booster of vaccination|Adverse events were reported from the Safety Analysis Set.|||Participants|||Number
1382417|NCT01437423|Other Pre-specified|Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unsolicited adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 year surveillance period|Up to 30 days post-primary and booster of TETRAXIM™ vaccination|Unsolicited adverse events were reported from the Safety Analysis Set.|||Participants|||Number
1382418|NCT01437423|Other Pre-specified|Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours.|Up to 30 days post-primary and booster vaccination|Solicited adverse events were reported from the Safety Analysis Set.|||Participants|||Number
1382419|NCT01437423|Primary|Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period.|Up to 30 days post-primary and booster vaccination|Adverse events were reported from the Safety Analysis Set.|||Participants|||Number
1382420|NCT01437397|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|St George’s Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 2 parts with 3 dimension scores (a symptom score and an activity and impacts score). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).|Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Scores on a scale||Standard Error|Least Squares Mean
1382421|NCT01437397|Secondary|Change in Transition Dyspnea Index (TDI) Focal Score|"The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort).TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate no change. The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9."|Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Scores on a scale||Standard Error|Least Squares Mean
1382422|NCT01437397|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1)||Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
1382423|NCT01437397|Primary|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
1382424|NCT01437319|Primary|Corneal Infiltrate Event- Phase II|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|12-Month Follow-up|The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification.|||percentage of subjects|||Number
1382425|NCT01437319|Primary|Corneal Infiltrate Events - Phase I|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|1-Month Follow-up|The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective.|||percentage of subjects|||Number
1382426|NCT01437267|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population|||participants|||Number
1382427|NCT01437267|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1382428|NCT01437267|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1382430|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.|||percentage of subjects||95% Confidence Interval|Number
1382431|NCT01437124|Secondary|Chromosomal Abnormality|Deviation of karyotype from normal 2 years post THR|2 years post THR|24 colour FISH|||% chromosomal abberations||95% Confidence Interval|Mean
1382432|NCT01437124|Primary|Cobalt Chromium Levels|Serum cobalt chromium levels post THR|2 years post THR|metal ion levels|||micrograms/dl||95% Confidence Interval|Mean
1382433|NCT01437111|Secondary|Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26|Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.|Baseline and Week 26|Per Protocol Population consisted of FAS but excluded participants who had important deviations from protocol or did not complete study on study drug. For analysis, participants in Per Protocol Population were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve.|||Percent change||Standard Deviation|Mean
1382434|NCT01437111|Primary|Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26|Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.|Week 26|Full Analysis Set (FAS) consisted of participants who received >=1 dose of study drug; had >=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve|||Participants|||Number
1382435|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 36 Months||||Points||Inter-Quartile Range|Median
1382436|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 24 Months||||Points||Inter-Quartile Range|Median
1382437|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 12 months||||Points||Inter-Quartile Range|Median
1382438|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 6 months||||Points||Inter-Quartile Range|Median
1382439|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 30 days|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Q of L available at this visit were analyzed. Not everyone followed to this visit had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||Points||Inter-Quartile Range|Median
1382440|NCT01437098|Secondary|Valve-related Deaths||0 day to 36 months||||prob of freedom from event @ 1095 days|||Number
1382441|NCT01437098|Secondary|Valve-related Deaths||0 day to 24 months||||prob of freedom from event @ 730 days|||Number
1382442|NCT01437098|Secondary|Valve-Related Deaths||0 day to 12 months||||prob of freedom from event @ 365 days|||Number
1382443|NCT01437098|Secondary|Valve-related Deaths||0 day to 6 months||||prob of freedom from event @ 183 days|||Number
1382444|NCT01437098|Secondary|Valve-related Deaths||0 day to 30 days||||prob of freedom from event @ 30 days|||Number
1382445|NCT01437098|Secondary|Repeat Hospitalization||0 day to 36 months||||prob of freedom from event @ 1095 days|||Number
1382446|NCT01437098|Secondary|Repeat Hospitalization||0 day to 24 months||||prob of freedom from event @ 730 days|||Number
1382447|NCT01437098|Secondary|Repeat Hospitalization||0 day to 12 months||||prob of freedom from event @ 365 days|||Number
1382448|NCT01437098|Secondary|Repeat Hospitalization||0 day to 6 months||||prob of freedom from event @ 183 days|||Number
1382449|NCT01437098|Secondary|Repeat Hospitalization||0 day to 30 days||||prob of freedom from event @ 30 days|||Number
1382450|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percentage of participants|||Number
1382451|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Total AR available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percentage of participants|||Number
1382452|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||12 months||||percentage of participants|||Number
1382453|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||6 months||||percentage of participants|||Number
1382454|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||30 days||||percentage of participants|||Number
1382455|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percent||Standard Deviation|Mean
1382456|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percent||Standard Deviation|Mean
1382457|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||12 months||||percent||Standard Deviation|Mean
1382458|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||6 months||||percent||Standard Deviation|Mean
1382459|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||30 days||||percent||Standard Deviation|Mean
1382460|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||cm²||Standard Deviation|Mean
1382461|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had EOA measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||cm²||Standard Deviation|Mean
1382462|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||12 months||||cm²||Standard Deviation|Mean
1382463|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||6 months||||cm²||Standard Deviation|Mean
1382464|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||30 days||||cm²||Standard Deviation|Mean
1382465|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||mmHg||Standard Deviation|Mean
1382466|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had mean gradients available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||mmHg||Standard Deviation|Mean
1382467|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||12 months||||mmHg||Standard Deviation|Mean
1382468|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient||6 months||||mmHg||Standard Deviation|Mean
1382469|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||30 days||||mmHg||Standard Deviation|Mean
1382470|NCT01437098|Secondary|Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.||after procedure or discharge||||percentage of participants|||Number
1382493|NCT01436500|Secondary|Change in 24-hour Urine Volume|The volume of urine collected in a 24-hour post-treatment period minus the volume collected in a 24-hour pre-treatment period.|Baseline to Hour 96|Data were missing for the post-treatment urine volume measurements in 9 of 42 ifetroban patients and 3 of 13 placebo patients so they were excluded from the analysis.|||mL||Standard Deviation|Mean
1382494|NCT01436500|Secondary|The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements||Day 0 to Day 5||||percentage of participants|||Number
1382471|NCT01437098|Secondary|Device Success as Defined in the Description.|"successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system~correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)~Intended performance of the prosthetic valve (aortic valve area >1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR)~Only one valve implanted in the proper anatomical location"|after procedure or discharge|The AT cohort that went through an index procedure were analyzed for Device Success. Also, all components that went into the success measures had to be non-missing. Therefore n=53.|||percentage of participants|||Number
1382472|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 36 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event at 1095 days|||Number
1382473|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 24 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event at 730 days|||Number
1382474|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 12 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 365 days|||Number
1382475|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 6 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 183 days|||Number
1382476|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 30 days|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 30 days|||Number
1382477|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 Months||||percentage of participants|||Number
1382478|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 Months||||percentage of participants|||Number
1382479|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 Months||||percentage of participants|||Number
1382480|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months||||percentage of participants|||Number
1382495|NCT01436500|Secondary|Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL||Day 0 through Day 5||||percentage of participants|||Number
1382481|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|NYHA denominators included deaths (n=2). Taken deaths out, you have n=51 at 30 days.|||percentage of participants|||Number
1382482|NCT01437098|Primary|Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).|The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.|baseline and 6 months|All subjects implanted with the MDT-2111 device.|||percentage of participants|||Number
1382483|NCT01436799|Primary|Regional Cerebral Oxygen Satuation (rSO2)|definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)|1, 3, 5, 7, and 9 min after the beach chair position|A power analysis was calculated based on a previous study.14 In each group, 16 patients were needed to detect a mean intergroup difference of 5% in the rSO2 value with a power of 80% and a type I error of 0.05. To compensate for a dropout rate of 20%, 40 patients were included in this study.|||percentage of rSO2 (%)||Standard Deviation|Mean
1382484|NCT01436643|Primary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|"In this analysis patients with all (serious and non-serious) adverse events, and death were reported.~See Safety Section."|21 weeks|The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant|||Participants|||Number
1382485|NCT01436526|Secondary|Half-life Associated With the Terminal Slope (t½)|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||hr||Geometric Coefficient of Variation|Geometric Mean
1382486|NCT01436526|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||hr||Full Range|Median
1382487|NCT01436526|Secondary|Mean Residence Time (MRT)|The mean residence time is the average time that the molecules introduced into the body stay in the body.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||hr||Geometric Coefficient of Variation|Geometric Mean
1382488|NCT01436526|Secondary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||kg/L||Geometric Coefficient of Variation|Geometric Mean
1382489|NCT01436526|Secondary|Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUCnorm is defined as AUC divided by dose per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||kg*hr/L||Geometric Coefficient of Variation|Geometric Mean
1382490|NCT01436526|Primary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||µg/L||Geometric Coefficient of Variation|Geometric Mean
1382491|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC (0-tn)] is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
1382492|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample (AUC is defined as area under the concentration vs. time curve from zero to infinity after single (first) dose).|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
1382497|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment|Plasma concentrations of ifetroban and it's major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.|||ng/mL||Standard Deviation|Mean
1382498|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment|Plasma concentrations of ifetroban and its primary active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
1382499|NCT01436500|Primary|Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide|Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.|||hours||Standard Deviation|Mean
1382500|NCT01436435|Secondary|Major Adverse Events (MAE)|Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||Major Adverse Events|||Number
1382501|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable.|||percentage of patients|||Number
1382502|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable.|||percentage of patients|||Number
1382503|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||percentage of patients|||Number
1382504|NCT01436435|Secondary|Procedural Success|Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy|Index Procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of patients|||Number
1382505|NCT01436435|Primary|Binary Restenosis|Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable.|||percentage of patients|||Number
1382506|NCT01436370|Secondary|Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.|||participants|||Number
1382507|NCT01436370|Secondary|Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2011-2012 vaccines.|||participants|||Number
1382530|NCT01436305|Secondary|Count of Participants With Use of Anti-hypertensive Medications at Wk 52|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction.|Week 52|Intent-to-treat with available data at Week 52|||Participants|||Count of Participants
1382508|NCT01436370|Secondary|Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire|The RAPID 3 score is an index of the three patient-reported measures from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) R808 and serves as an assessment of patient status for those with rheumatoid arthritis. The score consists of the cumulative total of the Function (FN), Pain (PN), and Patient Global (PTGL) values. The severity of the RAPID 3 score is categorized as: >12=High Severity; 6.1-12=Moderate Severity; 3.1-6=Low Severity; and ≤3=Remission. The NP2 questionnaire was completed by RA participants at all clinic visits. Scores at Days 7, 21 and 180 were compared to Day 0 to determine worsening, defined as moving from the baseline category to a more severe category.|Day 0 to Days 7, 21 and 180|All RA participants are included in the analysis population for this outcome measure.|||participants|||Number
1382509|NCT01436370|Secondary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes RA participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose recipient is not included at Day 180 because the participant was out of window.|||participants|||Number
1382510|NCT01436370|Secondary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes all RA subjects enrolled and vaccinated with the 2011-2012 vaccines.|||participants|||Number
1382511|NCT01436370|Primary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2012-2013 vaccines.|||participants|||Number
1382512|NCT01436370|Secondary|Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
1382513|NCT01436370|Secondary|Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
1382514|NCT01436370|Secondary|Number of Participants Reporting Fever|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
1382515|NCT01436370|Secondary|Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, shivering, and asthenia for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
1382516|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2012-2013 seasonal inactivated TIV. Within each 2012-2013 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180|The analysis population includes all participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.|||titers||95% Confidence Interval|Geometric Mean
1382557|NCT01436279|Primary|Length of Procedure|Interval from speculum insertion to speculum removal|Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.||||minutes||95% Confidence Interval|Mean
1382517|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2011-2012 seasonal inactivated TIV. Within each 2011-2012 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180||||titers||95% Confidence Interval|Geometric Mean
1382518|NCT01436370|Secondary|Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study.|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 to Day 180|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
1382519|NCT01436370|Primary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2011-2012 vaccines.|||participants|||Number
1382520|NCT01436305|Secondary|Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure|Temperature of >39 degrees Celsius would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.|24 hours after transplantation|Intent-to-treat|||Participants|||Count of Participants
1382521|NCT01436305|Secondary|Count of Participants With EBV Infection as Reported on the Case Report Form as Adverse Events|"Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.~Acronym: Epstein-Barr virus (EBV)"|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382522|NCT01436305|Secondary|Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events|"Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.~Acronyms: BK Polyoma Virus (BKV); Cytomegalovirus (CMV)."|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382523|NCT01436305|Secondary|Count of Participants With Infections Requiring Hospitalization or Systemic Therapy Reported as Serious Adverse Events|Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization of prolongation of a current hospitalization.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382524|NCT01436305|Secondary|Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events were collected systematically from enrollment through last study visit. Displayed below are counts of all adverse events per treatment group (including both serious and non-serious adverse events). Separately counts of all adverse events determined to be serious are displayed per treatment group. More detail about adverse events for this trial is displayed in the ‘Adverse Event’ section.|Enrollment through last study visit (up to week 156)|Intent-to-treat|||Events|||Number
1382525|NCT01436305|Secondary|Count of Participants With Rejection|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382526|NCT01436305|Secondary|Number of Events of Death or Graft Loss|This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as need for dialysis for greater than 30 days duration, allograft nephrectomy, or retransplantation.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Events|||Number
1382527|NCT01436305|Secondary|Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156|This is a measure of the total number of pills a participant was prescribed on a given day|Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156|Intent-to-treat with available data|||Number of pills||Standard Deviation|Mean
1382528|NCT01436305|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood|Baseline, Week 24, Week 52, Week 104, Week 156|Intent-to-treat|||Participants|||Count of Participants
1382529|NCT01436305|Secondary|Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one’s risk of cardiovascular disease. Target ranges for each of these measures are detailed below.~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease"|Baseline, Week 24, Week 52, Week 104, Week 156|Intent-to-treat|||mg/dL||Standard Deviation|Mean
1382531|NCT01436305|Secondary|Standardized Blood Pressure Measurement at Wk 52|A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart. Systolic measures of <120 and diastolic measures of <80 are considered normal. Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension). Systolic measures of ≥140 and diastolic measures of ≥90 are considered high.|Week 52|Intent-to-treat with available data at Week 52|||mmHg||Standard Deviation|Mean
1382532|NCT01436305|Secondary|HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156|Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control. A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes.|Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156|Intent-to-treat with available data|||percent||Standard Deviation|Mean
1382533|NCT01436305|Secondary|Count of Participants With Treated Diabetes Between Day 14 and Wk 52|Treated diabetes is defined as the receipt of oral medication or insulin for >14 days between 14 days and 52 weeks post-transplant|Day 14 to Week 52|Intent-to-treat with available data|||Participants|||Count of Participants
1382534|NCT01436305|Secondary|Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO|"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.~Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)."|Week 52|Intent-to-treat|||Participants|||Count of Participants
1382535|NCT01436305|Secondary|Count of Participants With de Novo Anti-donor HLA Antibodies at Wk 52|The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti- donor HLA antibodies may mean a person is more likely to reject the graft.|Week 52|Intent-to-treat|||Participants|||Count of Participants
1382536|NCT01436305|Secondary|Type of Treatment of Rejection|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of biopsy findings and corresponding treatment are presented here for each instance of treatment for rejection. Acronyms and abbreviations are defined below.~ACR=Acute Cellular Rejection ATG=Anti-thymocyte globulin therapy Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy IVIG=Intravenous Immunoglobulin therapy.~Only ‘for cause’ biopsies were performed post-transplant; thus, it is possible for a participant to be included in the analysis population and not have a biopsy for this outcome measure."|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Biopsy|Biopsies||Number
1382537|NCT01436305|Secondary|Count of Participants With Antibody Mediated Rejection|Antibody mediated rejection (AMR) is defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies and morphologic evidence of acute tissue injury.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382538|NCT01436305|Secondary|Count of Participants by Severity of First Acute Cellular Rejection by Wk 52|Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally, this endpoint was worded as “The severity of first and highest acute cellular rejection within the first 52 weeks.” But since the highest grade for each subject coincided with the first ACR episode for each subject, only a summary of severity of the first episode is presented here.|Transplantation through Week 52|Intent-to-treat|||Participants|||Count of Participants
1382539|NCT01436305|Secondary|Count of Participants With Acute Cellular Rejection Grade Equal to or Greater Than IA, by the Banff 2007 Criteria|Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382540|NCT01436305|Secondary|Count of Participants With CAN/IFTA Grade I, II or III at Any Time Post-transplant|CAN/IFTA grades were determined per local pathology interpretations of biopsy tissue. These grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382541|NCT01436305|Secondary|An Increase of One or More Grades of CAN/IFTA When Comparing the Implantation and Subsequent Protocol Biopsies|CAN/IFTA grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue. The aim of this measure was to compare central lab reviewed pre-implantation biopsies to post-transplant biopsies, as pre-specified per protocol; however, the central lab had an inadequate set of biopsies to proceed with evaluation.|Week 52, Week 104, and Week 156|There was an insufficient number of biopsies collected for the summarized data to be reliable.||||||
1382542|NCT01436305|Secondary|Count of Participants With Delayed Graft Function Post-Transplant|Delayed graft function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function|Any time within the first week post-transplant|Intent-to-treat|||Participants|||Count of Participants
1382558|NCT01436266|Primary|Blood Loss|500 cc or more|one day following the procedure||||Participants|||Count of Participants
1384155|NCT01419769|Secondary|Clinical Success|Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol.|||percentage of patients|||Number
1382543|NCT01436305|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine|The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it can be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function.|Week 52, Week 104, and Week 156|Intent-to-treat with available data|||Change in eGFR (mL/min/1.73m^2) by month||Standard Deviation|Mean
1382544|NCT01436305|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model|The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156|||mL/min/1.73m^2||Standard Deviation|Mean
1382545|NCT01436305|Secondary|Count of Participants With CKD Stage 4 or 5|"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below.~Stage 1 if GFR value is ≥90; Stage 2 if 60 ≤ GFR < 90; Stage 3A if 45 ≤ GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤ GFR < 30; Stage 5 if GFR < 15.~Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A abd 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure."|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156|||Participants|||Count of Participants
1382546|NCT01436305|Secondary|Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant|"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below:~Stage 1 if GFR value is ≥90; Stage 2 if GFR value is ≥60 and < 90; Stage 3A if 45 ≤GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤GFR < 30;l Stage 5 if GFR < 15.~Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A and 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure."|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156|||Participants|||Count of Participants
1382547|NCT01436305|Secondary|Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI|GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. This measure specifically looked at participants with scores less than 60.|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156.|||Participants|||Count of Participants
1382548|NCT01436305|Secondary|Count of Participants With Biopsy Proven Acute Rejection at Any Time Post-Transplant|Biopsy proven acute rejection was defined as histologic evidence of borderline or higher cellular rejection per local pathologist.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
1382549|NCT01436305|Primary|Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52|GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.|Week 52|Intent-to-treat population with measurable data at Week 52|||mL/min/1.73m^2||Standard Deviation|Mean
1382550|NCT01436279|Secondary|Difficulty of Procedure|"Outcome measure is the number and percentage of participants where the provider rated the procedure as difficult or very difficult. Provider assessment of difficulty of procedure categories were: very easy, easy, moderate, difficult, or very difficult."|After completion of procedure||||Participants|||Count of Participants
1382551|NCT01436279|Secondary|Acceptability to Patient|"Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was yes is being reported."|After procedure completion||||Participants|||Count of Participants
1382552|NCT01436279|Secondary|Cervical Dilation Achieved|Cervical dilation at start of procedure|At time of abortion||||mm||Standard Deviation|Mean
1382553|NCT01436279|Secondary|Pain Medication (Midazolam) During the Abortion|Amount of pain medication used during the procedure: reported as milligrams of midazolam|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||mg||Standard Deviation|Mean
1382554|NCT01436279|Secondary|Pain Medication (Fentanyl) During the Abortion|Amount of pain medication used during the procedure: reported as micrograms of fentanyl|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||mcg||Standard Deviation|Mean
1382555|NCT01436279|Secondary|Subject Discomfort Before the Abortion|Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||participants|||Number
1382556|NCT01436279|Secondary|Operative Time|Interval from initiation of vacuum aspiration to speculum removal|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||minutes||95% Confidence Interval|Median
1392169|NCT01335867|Secondary|Disease Severity and Improvement|Measures of disease severity and improvement will include the Clinical Global Impression Scale|8 weeks|||||||
1382559|NCT01436253|Primary|Percentage of Participants With Reduced Cardiovascular Risk|Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; >=17 total points for men, and >=25 total points for women indicates a >=30% risk of developing cardiovascular disease.|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.|||Percentage of participants|||Number
1382560|NCT01436253|Primary|Percentage of Participants Achieving Target Lipid Values|Target total cholesterol value was <4.5 mmol/L and target low densisty lipoprotein (LDL) value was <2.5 mmol/L|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1382561|NCT01436201|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Tmax data.|||hours||Full Range|Median
1382562|NCT01436201|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Cmax data.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1382563|NCT01436201|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin AUC data.|||nanograms times hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1382564|NCT01436175|Secondary|PRUQ-MDD – Effect of Depressive Symptoms|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale – 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories|||units on scale||Standard Deviation|Mean
1382565|NCT01436175|Secondary|PRUQ-MDD – Number of Hours|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
1382566|NCT01436175|Secondary|PRUQ-MDD – Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions – 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories|||events||Standard Deviation|Mean
1382567|NCT01436175|Secondary|PRUQ-MDD – Number of Days of Resource Utilization|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.|||days||Standard Deviation|Mean
1382568|NCT01436175|Secondary|Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)|"The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions:~1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is.~Number of participants with response is reported."|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure|||participants|||Number
1382569|NCT01436175|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Week 53|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1382570|NCT01436175|Secondary|Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET|CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
1392170|NCT01335867|Secondary|Addiction Severity|Measures of addiction severity will include the Addiction Severity Index (ASI)|8 weeks|||||||
1382571|NCT01436175|Secondary|Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories|||units on a scale||Standard Deviation|Mean
1382572|NCT01436175|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure|||units on a scale||Standard Deviation|Mean
1382573|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale|EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1382574|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1382575|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1382576|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1382577|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1382578|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1382579|NCT01436175|Secondary|Short Form-12 Health Survey Version 2 (SF-12V2)|SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1382580|NCT01436175|Secondary|Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)|Participants who did not have Clinical Global Impressions – Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1382592|NCT01436162|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382581|NCT01436175|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET|"Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.~Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162])."|Baseline, Week 52/ET|Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points.|||units on a scale||Standard Deviation|Mean
1382582|NCT01436175|Primary|Change From Baseline in Pulse Rate at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.|||beats per minute(bpm)||Standard Deviation|Mean
1382583|NCT01436175|Primary|Change From Baseline in Diastolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.|||mmHg||Standard Deviation|Mean
1382584|NCT01436175|Primary|Change From Baseline in Systolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.|||millimeter of mercury(mmHg)||Standard Deviation|Mean
1382585|NCT01436175|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Week 5 up to Week 52/Early Termination(ET)|Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study|||participants|||Number
1382586|NCT01436162|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an AE, or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).|||Score||Standard Deviation|Mean
1382587|NCT01436162|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an adverse event [AE], or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382588|NCT01436162|Secondary|Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI)|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Error|Least Squares Mean
1382589|NCT01436162|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382590|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Female subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Deviation|Mean
1382591|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Male subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Deviation|Mean
1382634|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Head CT Examinations.||One year||||mGy||Standard Deviation|Mean
1382647|NCT01435798|Primary|Mean Pain Intensity (Percent Change From Baseline)|Primary outcome was percent change from baseline in mean pain intensity (transformed Gracely Scale; 0-35). Baseline was defined as the week prior to randomization. The greater the percent change, the bigger the reduction in pain intensity.|1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)||||Percent change from baseline||Standard Error|Mean
1382593|NCT01436162|Secondary|Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores|The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||t-score||95% Confidence Interval|Least Squares Mean
1382594|NCT01436162|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of MADRS total score after the Augmentation Baseline Visit (Visit 8). Sample size (n) of MADRS total score at each visit differed from sample size (N) of the FAS.|||units on a scale||95% Confidence Interval|Least Squares Mean
1382595|NCT01436162|Secondary|Percent of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382596|NCT01436162|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e. ≥50% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382597|NCT01436162|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e. ≥25% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382598|NCT01436162|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382599|NCT01436162|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382600|NCT01436149|Secondary|Amphetamine Cessation Symptom Assessment (ACSA)|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Deviation|Mean
1382601|NCT01436149|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382602|NCT01436149|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382603|NCT01436149|Secondary|Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1383218|NCT01430754|Secondary|Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase|LQ-nTST measures the average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) from run-in and randomized phase. The higher number indicates improvement.|Approximately 12 weeks||||minutes||Standard Error|Mean
1382604|NCT01436149|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382605|NCT01436149|Secondary|Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)|The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382606|NCT01436149|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382607|NCT01436149|Secondary|Percentage of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382608|NCT01436149|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382609|NCT01436149|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
1382610|NCT01436149|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382611|NCT01436149|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
1382612|NCT01436110|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 24/Early Withdrawal|ITT Population|||Participants|||Number
1382613|NCT01436110|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1382614|NCT01436110|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1382615|NCT01436110|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1382616|NCT01436110|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1382617|NCT01436110|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
1382618|NCT01436084|Primary|Number of Participants With Overall Response|Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still > 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.|28 days to one year|Study was halted prior to completion of treatment and assessment for any participant(s).||||||
1382619|NCT01436071|Secondary|Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 12/Early Withdrawal|ITT Population|||Participants|||Number
1382620|NCT01436071|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1382621|NCT01436071|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1382622|NCT01436071|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1382623|NCT01436071|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1382624|NCT01436071|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
1382625|NCT01436045|Primary|Trails B - Errors|The results are presented as the mean sum of the errors during the Trails B assessment For each of these, a higher number of errors is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration||||mean number of errors||Standard Error|Mean
1382626|NCT01436045|Primary|Trails B - Seconds|The results are presented as the number of seconds to complete Trails B. For each of these, a higher number of seconds is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration||||mean seconds||Standard Error|Mean
1382627|NCT01436045|Secondary|Olfactory Function|"The Sniff Magnitude Test (SMT) measures olfactory function not influenced by cognitive problems (minimal dependence on language, cognitive ability, memory, and odor naming ability). Sniff magnitude ratios are calculated as a ratio of sniff magnitudes (area under the sniff curve). Lower sniff magnitude ratios indicate more impairment.~[average sniff magnitude of malodor/average sniff magnitude to a null odor]"|60 minute post intranasal administration||||ratio of area under the sniff curve||Standard Error|Mean
1382628|NCT01436045|Primary|Cognitive Performance|"The results are presented as a mean number of correct responses for each cognitive assessment.~For each of these, a lower number correct is indicative of a higher cognitive deficit.~Ranges are as follows: RBANS List Learning (0-40), RBANS Story Memory (0-24), RBANS Figure Copy (0-20), RBANSLine Orientation (0-20), RBANS Semantic Fluency (0-unlimited), RBANS List Recall (0-10), RBANS List Recognition (0-20), RBANS Story Recall (0-12), RBANS Figure Recall (0-20), Digit Span Forward (0-16), Digit Span Backward (0-16), Boston Naming (0-15)."|20 minutes post-intranasal administration||||mean total correct responses||Standard Error|Mean
1382629|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Spine CT Examinations.||one year||||mGy||Standard Deviation|Mean
1382630|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest Abdomen and Pelvis CT Examinations.||one year||||mGy||Standard Deviation|Mean
1382631|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Cardiac CT Examinations.||one year||||mGy||Standard Deviation|Mean
1382632|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations.||one year||||mGy||Standard Deviation|Mean
1382633|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest CT Examinations.||one year||||mGy||Standard Deviation|Mean
1382635|NCT01435928|Secondary|Intent to Attend (ITA) Assessment at Open-label Baseline|The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = “Not at all” and 9 = “Extremely”. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the screening visit: “How likely is it that you will complete the study?”|Open Label Baseline|All subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||units on a scale||Standard Deviation|Mean
1382636|NCT01435928|Secondary|Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)|Smoking history and frequency were assessed during the study by a research staff member. During the study, smoked subjects were asked about the average number of cigarettes per day they smoked over the last week.|28 Weeks - Double Blind Phase|ITT Subjects who smoked|||number of cigarettes smoked daily||Standard Deviation|Mean
1382637|NCT01435928|Other Pre-specified|EuroQol (EQ-5D): EQ-VAS Score|"The EQ-5D is a self-administered, standardized measure of health states consisting of two parts: EQ-5D descriptive system consisting of one question in each of five dimensions (mobility, self-care, pain, usual activities, and anxiety) with three possible response levels per question, classifying patients into one of 243 distinct health states, and a 20-cm visual analogue health status rating.~The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1382638|NCT01435928|Secondary|Brief Adherence Rating Scale|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 - 100%) of doses taken by the subject in the previous month.|Double-blind phase - 28 Weeks|There were 6 Lurasidone subjects and 2 placebo subjects that had no post-baseline assessment.|||percentage of monthly doses taken||Standard Deviation|Mean
1382639|NCT01435928|Secondary|Change From Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) Total Score|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items divided into two subscales: Social functioning (comprised of 7 items from interpersonal relationships section) and Community Living Skills (comprised of 17 items from activities and work skills sections). Each item is rated on a 5-point scale and mapped to 0 to 4 with a higher score indicating worse condition. The total score will be the sum of all 24 items and ranges from 0 to 96.|Double-blind phase - 28 Weeks|There were 19 Lurasidone subjects and 20 placebo subjects that had no post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1382640|NCT01435928|Secondary|Change From Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score|"The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales.~Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline SF-12 assessment.|||units on a scale||Standard Error|Least Squares Mean
1382641|NCT01435928|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Double-blind phase - 28 Weeks|There were four Lurasidone subjects and 2 placebo subjects that had no post-baseline MADRS assessment.|||units on a scale||Standard Error|Least Squares Mean
1382642|NCT01435928|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Double-blind phase - 28 Weeks||||units on a scale||Standard Error|Least Squares Mean
1382643|NCT01435928|Secondary|Change From Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three scales: the Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Double-Blind phase - 28 Weeks||||units on a scale||Standard Error|Least Squares Mean
1382644|NCT01435928|Secondary|Time to All-cause Discontinuation|The Kaplan-Meier method was used for estimation.|Double-blind phase - 28 weeks||||days||95% Confidence Interval|Median
1382645|NCT01435928|Primary|Time to First Relapse Event During Double-blind Phase|The Kaplan-Meier method is used for the estimation.|Double-blind phase - 28 Weeks||||days||95% Confidence Interval|Median
1382646|NCT01435798|Secondary|Satisfaction|Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)|Last week prior to admission (end of 1-week maintenance period)||||Participants|||Count of Participants
1382648|NCT01435772|Secondary|Insulin-like Growth Factor Binding Protein 3 (IGFBP3)|insulin-like growth factor binding protein 3 from lab|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||nmol/L||Standard Deviation|Mean
1382649|NCT01435772|Secondary|Plasma IGF-II Concentration|Plasma IGF-II concentration from lab|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||nmol/L||Standard Deviation|Mean
1382650|NCT01435772|Secondary|Plasma IGF-I Concentration|Plasma IGF-I concentration from lab|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||nmol/L||Standard Deviation|Mean
1382651|NCT01435772|Secondary|Change From Baseline in Urine Tetrasaccharide Concentration at Week 144|Change from Baseline in Urine Tetrasaccharide Concentration at Week 144|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||mmol/mol||Standard Deviation|Mean
1382652|NCT01435772|Secondary|Percent Predicted Upright Forced Vital Capacity (FVC)|Pulmonary function test: Percent Predicted Upright Forced Vital capacity|Baseline, Week 144|Full Analysis Set.|||Percent Predicted||Standard Deviation|Mean
1382653|NCT01435772|Secondary|Percent Predicted Upright Forced Vital Capacity (FVC)|Pulmonary function test: Percent Predicted Upright Forced Vital Capacity|Baseline, Week 144|Full Analysis Set.|||Percent Predicted||Standard Deviation|Mean
1382654|NCT01435772|Secondary|Maximum Voluntary Ventilation (MVV)|Pulmonary function test: Maximum Voluntary Ventilation (MVV)|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||L/min||Standard Deviation|Mean
1382655|NCT01435772|Secondary|6 Minutes Walk Test (Meters)|Distance walked within 6 minutes|Baseline, Week 144|Full Analysis Set.|||meter||Standard Deviation|Mean
1382656|NCT01435772|Secondary|Percent Predicted Maximum Expiratory Pressure (MEP)|Pulmonary Function Test: Percent Predicted Maximum Expiratory Pressure|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||Percent of Predicted||Standard Deviation|Mean
1382657|NCT01435772|Secondary|Percent Predicted Maximal Inspiratory Pressure (MIP)|Pulmonary Function Test: Percent Predicted Maximal Inspiratory Pressure|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||Percent of Predicted||Standard Deviation|Mean
1382658|NCT01435772|Primary|Number of Participants With a Positive Anti-BMN 701 Antibody Response|Status of Anti-IGF-II antibody is corresponding to the test results of blood samples|Baseline, Week 144|Full Analysis Set.|||Participants|||Count of Participants
1382659|NCT01435772|Primary|Number of Participants With a Positive Anti-BMN 701 Antibody Response|Status of Anti-IGF-I antibody is corresponding to the test results of blood samples|Baseline, Week 144|Full Analysis Set.|||Participants|||Count of Participants
1382660|NCT01435772|Primary|Number of Participants With a Positive Anti-BMN 701 Antibody|Status of Anti-BMN 701 antibody is corresponding to the test results of blood samples.|Baseline, Week 144|Full Analysis Set. Please note the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||Participants|||Count of Participants
1382661|NCT01435759|Primary|Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.|Augmentation Baseline (Week 8) to Week 16|Dose Response Evaluable Set (DRES): All randomized subjects who had at least 1 valid primary efficacy measurement (MADRS total score) during the Dose Maintenance Period (Weeks 11-16) while on the target dose level of investigational product.|||units on a scale||90% Confidence Interval|Least Squares Mean
1382662|NCT01435759|Secondary|Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.|||bpm||Standard Deviation|Mean
1382663|NCT01435759|Secondary|Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.|||mmHg||Standard Deviation|Mean
1382664|NCT01435759|Secondary|Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.|||mmHg||Standard Deviation|Mean
1382665|NCT01435655|Other Pre-specified|Plasma Concentration of Tafamidis at Week 8, Week 26, Week 52 and Week 78|Mean plasma concentration of tafamidis at 3 hours after administration|Week 8, Week 26, Week 52, Week 78|The PK Analysis Set included all participants treated who had at least 1 quantifiable plasma tafamidis concentration.|||ng/mL||Standard Deviation|Mean
1382674|NCT01435616|Secondary|Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)|The percentage of participants was calculated by dividing the number of participants equal or above 2- or 3-fold ULN for ALT/SGPT or AST/SGOT by the total number of participants analyzed, multiplied by 100.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline liver enzyme data.|||percentage of participants|||Number
1384156|NCT01419769|Secondary|Effectiveness: Technical Success|Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.|Up to 60 days|Intent-to-Treat population|||participants|||Number
1382666|NCT01435655|Secondary|Number of Participants With Transthyretin (TTR) Stabilization at Week 26, Week 52, and Week 78 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|TTR tetramer was assessed using a validated immunoturbidimetric assay. The TTR tetramer level for each plasma sample was measured before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the “TTR stabilization” is defined as the patient whose percent stabilization is equal to or more than 32%.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Participants|||Number
1382667|NCT01435655|Secondary|Change From Baseline in Ambulatory Status at Week 26, Week 52 and Week 78|Ambulatory status was evaluated using walking ability scale in polyneuropathy disability score. The ambulatory status was evaluated as: 0=Good, 1=Sensory disturbances in the feet but able to walk without difficulty, 2=Some difficulties with walking but can walk without aid, 3a=Able to walk with 1 stick or crutch, 3b=Able to walk with 2 sticks or crutches, 4=Not ambulatory, confined to a wheelchair or bedridden.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Participants|||Number
1382668|NCT01435655|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Week 8, Week 26, Week 52 and End of Study|The mBMI was calculated by multiplying the BMI (the weight in kilograms divided by the square of the height in meters) by serum albumin level (gram/liter). Change in mBMI was calculated as the mBMI at the given week minus the Baseline mBMI.|Baseline, Week 8, Week 26, Week 52, End of Study|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
1382669|NCT01435655|Secondary|Change From Baseline in Summated 3 Nerve Tests Small Fiber Normal Deviate Score (∑ 3 NTSF Nds) as Measured by Cooling and Heat Pain Thresholds by QST and HRDB at Week 26, Week 52 and Week 78|The Σ3 NTSF nds measures small-fiber function. It is a composite score defined as 3 times the mean of non-missing values of normal deviates of cooling threshold for lower limbs, heat pain intermediate response for lower limbs, and HRDB. The total score range is approximately -11.2 to 11.2, with a higher score demonstrating worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
1382670|NCT01435655|Secondary|Change From Baseline in Summated 7 Nerve Tests Normal Deviate Score (∑ 7 NTs Nds) as Measured by Nerve Conduction Studies (NCS), Vibration Detection Threshold (VDT) and Heart Rate Response to Deep Breathing (HRDB) at Week 26, Week 52, and Week 78|The Σ7 NTs nds measures primarily large-fiber function. It is a composite score derived from five NCS attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with VDT obtained in great toes by Quantitative Sensory Testing (QST), and HRDB value. It is defined as 7 times the mean of non-missing values of, the five normal deviates of NCS, HRDB, and average normal deviate for VDT of toes. Score was determined through reference to normal values for age, sex, height and abnormalities scored. Total score range is approximately -26 to 26, where higher score=worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
1382671|NCT01435655|Secondary|Change From Baseline in Scores of the Total Quality of Life (TQOL) and 5 Domains as Measured by the Norfolk QOL – Diabetic Neuropathy (Norfolk QOL-DN) at Week 26, Week 52 and Week 78.|Norfolk QOL-DN is a 35-item participant-rated questionnaire. It consists of 5 domains: Physical Functioning/Large Fiber [score range: -4 – 56] , Activities of Daily Living (ADL) [0 - 20], Symptoms [0 - 32], Small Fiber [0 - 16] and Autonomic [0 - 12]. Total of quality of life (TQOL) score is the sum of all five domains with a range of -4 to 136 (Pfizer Data Standards). Higher scores on each item of the Norfolk QOL-DN TQOL indicate worse quality of life.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
1382672|NCT01435655|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS); NIS (Total), NIS-LL (Lower Limb) and NIS-UL (Upper Limb) at Week 26, Week 52 and Week 78|The NIS provides a total body single score of neuropathic deficits (score range: 0-122, higher score = more deficit), comprising subset scores for cranial nerves, muscle weakness, reflexes, and sensation (based on mean of 2 scores in 1 week period; each item scored separately for left and right). The NIS-LL is a subscale that provides a score for the lower limbs functions (muscle weakness, reflexes and sensation in great toe) and has a score range of 0-44 (higher score = more deficit). The NIS-UL is a subscale that provides a score for the upper body functions (muscle weakness [including cranial nerves], reflexes and sensation in finger) and has a score range of 0-78 (higher score = more deficit). The components for cranial nerves and muscle weakness are scored from 0 (Normal) to 4 (Paralysis), and those for reflexes and sensation from 0 (Normal) to 2 (Absent). For all items, higher scores indicate greater impairment.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
1382673|NCT01435655|Primary|Number of Participants With Transthyretin (TTR) Stabilization at Week 8 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|TTR tetramer level for each plasma sample was assessed using a validated immunoturbidimetric assay before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer average concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the “TTR stabilization” is defined as the patient whose percent stabilization is equal to or more than 32%.|8 weeks|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Participants|||Number
1382702|NCT01435603|Primary|Percent Change in Body Weight|(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.|Baseline to 12 months|Participants who completed weight measurements at the baseline and 12 month exam|||percentage of change||Standard Deviation|Mean
1382675|NCT01435616|Secondary|Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia|The percentage of participants with HbA1C ≤ 6.5% or < 7.0% without nocturnal hypoglycemia is presented. Percentage was calculated by dividing the number of participants with the indicated HbA1c values over the total number of participants and multiplying by 100.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
1382676|NCT01435616|Secondary|Percentage of Participants With Total and Nocturnal Hypoglycemic Events|A hypoglycemic event is defined by a blood glucose value ≤70 mg/dL (3.9mmol/L). Total hypoglycemic events include documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemic events refer to any total hypoglycemic event that occurs between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic or nocturnal hypoglycemic events by the total number of participants analyzed, multiplied by 100.|Baseline to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable hypoglycemia event data.|||percentage of participants|||Number
1382677|NCT01435616|Secondary|Intra-participant Variability of the Fasting Blood Glucose (FBG)|Intra-participant variability of FBG, which was measured by SMBG, was assessed by the standard deviation of the FBG measurement at the Week 52 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline FBG data.|||mg/dL||Standard Error|Least Squares Mean
1382678|NCT01435616|Secondary|Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)|The percentage of participants with a TEAR is summarized. TEAR is defined as a change in the anti-LY2605541 antibody level from undetectable at baseline to detectable at baseline, or, for those participants with detectable antibodies at baseline, change to a value with at least a 130% relative increase from baseline. Overall TEAR is defined as one or more TEAR during the specified period.|Baseline to 78 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable TEAR data.|||percentage of participants|||Number
1382679|NCT01435616|Secondary|Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin||Up to 52 weeks|All participants who were randomized, had at least 1 dose of study drug, and had at least 1 post-baseline total bilirubin measurement.|||percentage of participants|||Number
1382680|NCT01435616|Secondary|Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)|LS means were calculated using a MMRM with baseline lipid measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Baseline, 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline lipid measurement.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1382681|NCT01435616|Secondary|Adult Low Blood Sugar Survey|The adult Low Blood Sugar Survey (LBSS) is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 4 = always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range of 0 to 132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using an analysis of covariance model (ANCOVA) with baseline LBSS score, stratification factors (country, HbA1c, and SU/meglitinide use), and treatment as fixed effects.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable LBSS data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
1382682|NCT01435616|Secondary|Insulin Treatment Satisfaction Questionnaire|The Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes who are receiving insulin. The questionnaire measures satisfaction from the following 5 domains: inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Data presented are the transformed total score on a scale of 0 to 100, where higher scores indicate better treatment satisfaction. LS means were calculated using a MMRM with stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ITSQ data.|||units on a scale||Standard Error|Least Squares Mean
1382683|NCT01435616|Secondary|European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using a MMRM with baseline stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable EQ-5D data.|||units on a scale||Standard Error|Least Squares Mean
1382684|NCT01435616|Secondary|Number of Insulin Dose Adjustments to Steady-State|Insulin doses were adjusted according to an algorithm (adapted from Riddle et al. 2003) during the first 26 weeks of the study and thereafter according to investigator judgment. Steady-state was defined as the first local maximum dose (maximum of moving 4-week interval) of LY2605541 or glargine within the window of +/- 2 weeks. The number of dose adjustments to steady-state was the total number of dose changes until steady-state was reached. LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Baseline to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline insulin data.|||number of insulin dose adjustments||Standard Error|Least Squares Mean
1382685|NCT01435616|Secondary|Insulin Dose Per Body Weight|LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable insulin dose data.|||units of insulin/kg body weight||Standard Error|Least Squares Mean
1382686|NCT01435616|Secondary|Hemoglobin A1c|HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.|||percentage of HbA1c||Standard Error|Least Squares Mean
1382687|NCT01435616|Secondary|Change From Baseline to 52 Weeks in Body Weight|LS means were calculated using a MMRM with baseline body weight measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Baseline, 52 weeks|All participants who were randomized, who received at least 1 dose of study drug, and had evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
1382688|NCT01435616|Secondary|6 Point Self-monitored Blood Glucose (SMBG)|Six-point SMBG profiles were obtained at pre-morning meal (fasting), pre-midday meal (lunch), pre-evening meal (dinner), bedtime, approximately 0300 hours, and pre-morning meal (fasting) the next day. Six-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to the next office visit. LS means were calculated using a MMRM with baseline blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
1382689|NCT01435616|Secondary|Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)|LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting blood glucose data.|||mg/dL||Standard Error|Least Squares Mean
1382690|NCT01435616|Secondary|Fasting Serum Glucose (By Laboratory Measurement)|LS means were calculated using a MMRM with baseline fasting serum glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting serum glucose data.|||mg/dL||Standard Error|Least Squares Mean
1382691|NCT01435616|Secondary|Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.|||percentage of participants|||Number
1382692|NCT01435616|Secondary|Rate of Total and Nocturnal Hypoglycemia Events|Hypoglycemia is a condition that occurs when a person's blood glucose level is lower than the normal range (less than or equal to 70 milligrams per deciliter [mg/dL] or less than 3.9 millimoles per liter [mmol/L]). Total hypoglycemia refers to an event that meets the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemia refers to any total hypoglycemic event that occurs between bedtime and waking. Group mean (listed as LS means below) rates of total and nocturnal hypoglycemia were calculated using a negative binomial regression model (number of episodes = treatment + SU/meglitinide use + baseline hypoglycemia event rate, with log [exposure per 30 days] as the offset variable in the model).|Baseline to 52 weeks|All participants who were randomized, who received at least 1 dose of study drug, and had evaluable total and/or nocturnal event data.|||episodes/participant/30 days||Standard Error|Least Squares Mean
1382693|NCT01435616|Primary|Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)|HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol [LDL-C, < 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL] and sulfonylurea [SU]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.|Baseline, 52 weeks|All participants who were randomized, had at least 1 dose of study medication, and at least 1 post-baseline HbA1c measurement.|||percentage of HbA1c||Standard Error|Least Squares Mean
1382694|NCT01435603|Secondary|Percent Change in Physical Activity||Baseline to 6, 12, and 24 months|||||||
1382695|NCT01435603|Secondary|Percent Change in Dietary Composition||Baseline to 6, 12, and 24 months|||||||
1382696|NCT01435603|Secondary|Percent Change in Blood Pressure||Baseline to 6, 12, and 24 months|||||||
1382697|NCT01435603|Secondary|Percent Change in A1c||Baseline to 6, 12, and 24 months|||||||
1382698|NCT01435603|Secondary|Percent Change in Blood Total Cholesterol||Baseline to 6, 12, and 24 months|||||||
1382699|NCT01435603|Secondary|Percent Change in Body Weight||Baseline to 6 and 24 months|||||||
1382700|NCT01435603|Secondary|Changes in Health State Utility|The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.|Baseline to 6,12, and 24 months|||||||
1382701|NCT01435603|Secondary|Incremental Costs|The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.|6, 12, and 24 months|||||||
1385443|NCT01402102|Secondary|Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)|HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis|||mg/dl||Standard Deviation|Mean
1382703|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data (indicated in brackets)|||units on a scale||Standard Deviation|Mean
1382704|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data.|||units on a scale||Standard Deviation|Mean
1382705|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol-O-glucuronide|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL."|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.|||ng/mL||Full Range|Mean
1382706|NCT01435577|Post-Hoc|Number of Participants Scored as a Responder Based on Patient Global Impression of Change|Responders are those participants with Patient Global Impression of Change (PGIC) values “Much improved”, or “Very much improved”. Participants with missing value are considered non-responders.|Fixed time points at 12, 24 and 48 hours after baseline|Participants with early second dose the PGIC assessment from End-of-double-blind Treatment was taken as the 48 hours value. Assessments done more than 4.5 hours after the 12th infusion were excluded from analysis and participants were considered non-responders.|||participants|||Number
1382707|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol|Tapentadol concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.|||ng/mL||Full Range|Mean
1382708|NCT01435577|Secondary|Time to Meaningful Pain Relief|The participant was instructed to stop the stopwatch when they had meaningful pain relief. That is, when the pain relief made a real difference, after the first drug administration.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time in hours to meaningful pain relief are not reported for matching placebo arm due to the high discontinuation rate.|||hours||95% Confidence Interval|Median
1382709|NCT01435577|Secondary|Time to Perceptible Pain Relief|When the participant began to feel any pain-relieving effect after the administration of the first dose they were requested to stop the first stopwatch. The time was noted. This measured when the participant first felt any difference in the pain.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time to perceptible pain relief is not reported for matching placebo arms because of the high number of discontinuations.|||hours||95% Confidence Interval|Median
1382710|NCT01435577|Secondary|Time to First Rescue Medication|The median time to first rescue medication intake (600 mg ibuprofen) in hours.|up to 48 hours|Full analysis set.|||hours||95% Confidence Interval|Median
1382711|NCT01435577|Secondary|Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.|||participants|||Number
1382712|NCT01435577|Secondary|Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.|||participants|||Number
1382713|NCT01435577|Secondary|Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.|||participants|||Number
1382714|NCT01435577|Secondary|Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores|Individual participants response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.|||participants|||Number
1382715|NCT01435577|Secondary|Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.|||participants|||Number
1382716|NCT01435577|Secondary|Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.|||participants|||Number
1382717|NCT01435577|Secondary|Sum of Pain Intensity Differences After 48 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 48 hours after first study drug administration|Full Analysis Set.|||units on a scale||95% Confidence Interval|Mean
1382718|NCT01435577|Secondary|Sum of Pain Intensity Differences After 12 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 12 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 12 hours after first study drug administration|Full Analysis Set.|||units on a scale||95% Confidence Interval|Mean
1382719|NCT01435577|Secondary|Sum of Pain Intensity Differences After 8 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 8 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 8 hours after first study drug administration|Full Analysis Set.|||units on a scale||95% Confidence Interval|Mean
1382720|NCT01435577|Secondary|Sum of Pain Intensity Differences After 4 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 4 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 4 hours after first study drug intake|Full analysis set. Primary imputation method was analyzed: Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 h after each rescue medication intake.|||units on a scale||95% Confidence Interval|Mean
1382721|NCT01435577|Secondary|Sum of Pain Intensity Differences After 60 Minutes|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the value is negative then the baseline pain intensity was greater than the pain intensity measured after dosing.|Baseline value to 60 minutes after first study drug administration|Full analysis set.|||units on a scale||95% Confidence Interval|Mean
1382722|NCT01435577|Secondary|Patient Global Impression of Change After 48 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 48 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.|||participants|||Number
1382723|NCT01435577|Secondary|Patients Global Impression of Change After 24 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 24 hours after study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.|||participants|||Number
1382724|NCT01435577|Secondary|Patient Global Impression of Change After 12 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 12 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.|||participants|||Number
1382725|NCT01435577|Secondary|Pain Intensity Differences at Fixed Time Points|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline pain intensity (prior to the first dose) and the pain intensity at the time. A negative number indicates a decrease in pain in the whole treatment group. The greater the negative pain intensity difference value the greater the pain relief in the treatment arm. A score of 0 indicates that there has been no change in pain in a treatment group. A positive value indicates an increase in pain in the treatment group.|Starting at 15 minutes and up to 48 hours after first drug administration|Full Analysis Set (FAS): Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.|||units on a scale||Standard Deviation|Mean
1382738|NCT01435382|Other Pre-specified|Number of Participants With Injection Site Reactions|The injection site reaction included erythema, induration, ecchymosis, injection site pain, injection site pruritus.|Day 1 up to Day 3|Safety analysis set included all participants who had at least 1 dose of study medication. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 200 mg.|||Participants|||Count of Participants
1382726|NCT01435577|Secondary|Mean Pain Intensity Scores at Fixed Time Points|The mean pain intensity at fixed time points in the trial for all participants is listed. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; up to 48 hours|Full Analysis Set (FAS). Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.|||units on a scale||Standard Deviation|Mean
1382727|NCT01435577|Primary|Sum of Pain Intensity Differences (SPID 24)|"Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline."|Baseline value; up to 24 hours after first study drug administration|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.|||units on a scale||95% Confidence Interval|Least Squares Mean
1382728|NCT01435460|Secondary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
1382729|NCT01435460|Secondary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
1382730|NCT01435460|Primary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
1382731|NCT01435460|Primary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
1382732|NCT01435382|Other Pre-specified|Percentage of Participants With Positive Anti-drug (Anti-PF 04950615) Antibodies|Human serum samples of participants who received PF-04950615 were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA).|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||percentage of participants|||Number
1382733|NCT01435382|Other Pre-specified|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)|ECG abnormalities included 1) PR interval: maximum >=300 maximum millisecond (msec), increase of >=25 percent (%) for baseline value of >200 msec and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec; 2) QRS interval: maximum >=200 msec, maximum increase of >=25 % for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec; 3) QT interval corrected using the Fridericia's formula (QTCF): 450 msec to <= 480 msec, 480 msec to <=500 msec, > 500 msec, maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec. Clinical significance of ECG were judged by investigator.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
1382734|NCT01435382|Other Pre-specified|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs abnormalities included: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg; supine pulse rate less than (<) 40 beats per minute (bpm) and greater than (>) 120 bpm; standing pulse rate less than (<) 40 beats per minute (bpm) and greater than (>) 140 bpm. Clinical significance of vital signs were judged by investigator.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
1382735|NCT01435382|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory parameters evaluated for abnormalities were: hematology (hemoglobin [Hgb], hematocrit, red blood cell [RBC] count, platelets, white blood cell count [WBC], lymphocytes, total neutrophils, basophils, eosinophils, monocytes); coagulation (partial thromboplastin time, prothrombin time [PT], PT international ratio); clinical chemistry (glucose, creatine kinase, amylase, lipase); liver function (total, direct and indirect bilirubin, aspartate aminotransferase [AT], alanine AT, gamma-glutamyl transferase, alkaline phosphatase, total protein, albumin, lactate dehydrogenase); renal function (blood urea nitrogen, creatinine, uric acid); urinalysis (urine- specific gravity, pH, glucose, ketones, blood/Hgb, nitrite, leukocyte, esterase, RBC, WBC, epithelial cells, hyaline cast and bacteria); lipid (cholesterol); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate). Clinical significance of laboratory abnormalities were judged by investigator.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
1382736|NCT01435382|Other Pre-specified|Visual Analogue Scale (VAS)|Participants indicated the amount of pain experienced due to study drug injection, on a VAS of 0 (no pain) to 100 (very severe pain), where higher scores indicate higher intensity of pain.|Day 1: Immediately post-dose, 0.5, 1.0, 2.0, 8.0 hours post-dose; Day 2, 3|Safety analysis set included all participants who had at least 1 dose of study medication. Here, “Number of Participants Analyzed” signifies number of participants evaluable at different time points.|||units on a scale||Standard Deviation|Mean
1382737|NCT01435382|Other Pre-specified|Number of Injection Site Reactions Reported as Adverse Events|The injection site reactions included erythema, induration, ecchymosis, injection site pain and injection site pruritus. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1 up to Day 3|Safety analysis set included all participants who had at least 1 dose of study medication. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 200 mg IV.|||injection site reactions|||Number
1382739|NCT01435382|Other Pre-specified|Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
1382740|NCT01435382|Other Pre-specified|Number of Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||adverse events|||Number
1382741|NCT01435382|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
1382742|NCT01435382|Secondary|Duration of Fasting LDL-C Suppressed Below 70 mg/dL and 100 mg/dL||Day 1 up to Day 85|PD population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or PCSK9 data. Here, “Number of Participants Analyzed” signifies number of participants evaluable at different time points.|||days||Standard Deviation|Mean
1382743|NCT01435382|Secondary|Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71 and 85|Baseline was the average of observations collected on Days 7 and 1 prior to the study treatment administration.|Baseline, Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85|PD population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or PCSK9 data. Here, “Number of Participants Analyzed” signifies number of participants evaluable at different time points.|||percent change||Standard Deviation|Mean
1382744|NCT01435382|Secondary|Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C)||Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85|Pharmacodynamic (PD) population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or proprotein convertase subtilisin/kexin type 9 (PCSK9) data. Here, “Number of participants analyzed” signifies number of participants evaluable at different time points.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1382745|NCT01435382|Primary|Absolute Bioavailability of PF-04950615 Subcutaneous Groups|Bioavailability is defined as the rate and extent to which the active moiety administered drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was estimated by comparing log-transformed dose-normalized AUClast for subcutaneous to intravenous dose.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was not analyzed in reporting arm: PF‑04950615 IV 200 mg.|||percentage of bioavailability||95% Confidence Interval|Number
1382746|NCT01435382|Primary|Terminal Elimination Half-life (t1/2) of PF-04950615|t1/2 is the time measured for the plasma concentration of drug to decrease by one half.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure.|||hour||Standard Deviation|Mean
1382747|NCT01435382|Primary|Volume of Distribution at Steady State (Vss) of PF-04950615 Intravenous Group|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is determined when overall intake of drug is in dynamic equilibrium with its elimination.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arms: PF-04950615 SC 200 mg (2 injections of 1mL), PF-04950615 SC 200 mg (1 injection of 2 mL) and PF-04950615 SC 100 mg (1 injection of 1 mL).|||milliliter||Standard Deviation|Mean
1382748|NCT01435382|Primary|Apparent Volume of Distribution (Vz/F) of PF-04950615 Subcutaneous Groups|Volume of distribution (Vz) is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arm: PF‑04950615 IV 200 mg.|||milliliter||Standard Deviation|Mean
1382814|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382749|NCT01435382|Primary|Clearance (CL) of PF-04950615 Intravenous Group|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arms: PF-04950615 SC 200 mg (2 injections of 1mL), PF-04950615 SC 200 mg (1 injection of 2 mL) and PF-04950615 SC 100 mg (1 injection of 1 mL).|||milliliter per hour||Standard Deviation|Mean
1382750|NCT01435382|Primary|Apparent Clearance (CL/F) of PF-04950615 Subcutaneous Groups|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance (CL/F) is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arm: PF‑04950615 IV 200 mg.|||milliliter per hour||Standard Deviation|Mean
1382751|NCT01435382|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) of PF‑04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
1382752|NCT01435382|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF‑04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' (Overall Number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
1382753|NCT01435382|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
1382754|NCT01435382|Primary|Maximum Observed Plasma Concentration (Cmax) of PF‑04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1382755|NCT01435304|Secondary|Number of Participants on Vasoactive Drugs at 48 Hours Post op Point|This metric is a surrogate for low output failure and /or vasoplegia depending upon whether inotropes or vasoconstrictors are used.|Any intravenous vasoactive drug being used at the 48 hour time point postoperative||||Participants|||Count of Participants
1382756|NCT01435304|Secondary|Number of Participants With Stroke|Any neurological defect according to Society of Thoracic Surgery (STS) definition|Index admission postoperative until the time of discharge, an expected average of 7 days.||||Participants|||Count of Participants
1382757|NCT01435304|Secondary|Number of Participants With a Mortality|Patients will be followed until hospital discharge|Index admission postoperative until the time of discharge, an expected average of 7 days.||||Participants|||Count of Participants
1382758|NCT01435304|Secondary|Number of Participants With Acute Kidney Injury (AKI)|Using the Acute Kidney Injury Network (AKIN) definition of a 0.03mg/dL increase in serum creatinine within 48 hours of surgery, serial postoperative creatinines will reflect the presence of AKI when compared with the baseline creatinine.|All creatinines will be recorded and assessed during the entire index admission in order to compare postoperative to preoperative baseline creatinine, an expected average of 7 days.||||Participants|||Count of Participants
1382759|NCT01435304|Secondary|Number of Participants Which Had Blood Products Transfused (RBC's, Platelets, FFP)|These blood components can be a metric of the success of achieving a satisfactory coagulation status.|All blood products transfused during index admission, an expected average of 7 days, with the exception of preoperative transfusions.||||Participants|||Count of Participants
1382760|NCT01435304|Primary|Amount of Chest Catheter Drainage 24 Hours Postoperatively|Chest catheters are placed in the mediastinum and sometimes pleural space(s) to collect shed mediastinal blood in the first 24 hours post operative cardiac surgery|Total amount for the first 24 hours postoperative||||mL||Standard Deviation|Mean
1382761|NCT01435265|Secondary|Adherence to Adalimumab Treatment|Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.|Baseline to 12 months|All participants|||days||Standard Deviation|Mean
1382762|NCT01435265|Primary|Investigator's Global Assessment (IGA) of Psoriasis|Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).|12 months|All participants completing the study.|||participants|||Number
1382763|NCT01435265|Primary|Change in Psoriasis Area Severity Index (PASI-75)|The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.|Baseline, 1 month, 3 months, 6 months, 9 months, 12 months|All participants who completed the study.|||participants|||Number
1382764|NCT01435174|Primary|Pharmacokinetic Parameters of Ranolazine|Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine|At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65||||mcg/mL||Standard Deviation|Mean
1385444|NCT01402102|Primary|Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)|LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dl||Standard Deviation|Mean
1382765|NCT01435122|Secondary|Occurrence of Possibly Related Adverse Events (AEs)|Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.|12 Months|All participants.|||percentage of participants|||Number
1382766|NCT01435122|Secondary|Time to Treatment Failure|Time to Treatment Failure: Time from administration of the initial dose of axitinib until study discontinuation for any reason (e.g., disease progression, toxicity, death, withdrawal of consent).|12 Months|All participants.|||months||95% Confidence Interval|Median
1382767|NCT01435122|Secondary|24 Month Overall Survival (OS) Rate|Overall survival by Kaplan Meier, determined from the time of drug administration to death from any cause. The effect of an intervention is assessed by measuring the number of subjects survived or saved after that intervention over a period of time. The time starting from a defined point to the occurrence of a given event, for example death is called as survival time and the analysis of group data as survival analysis.|24 months|All participants|||percentage of participants|||Number
1382768|NCT01435122|Secondary|Tumor Response Rate|Tumor response rate using RECIST. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|12 Months|All participants evaluable at time of analysis.|||Participants|||Count of Participants
1382769|NCT01435122|Primary|Median Progression Free Survival|Post follow-up progression free survival at time of analysis.|Up to 36 Months|All participants.|||months||95% Confidence Interval|Median
1382770|NCT01435122|Primary|Rate of Progression Free Survival (PFS)|Progression-free survival rate at 12 months. PFS: determined as the time from administration of the initial dose of axitinib until objective tumor progression using Response Evaluation Criteria In Solid Tumors (RECIST), or death. Progressive Disease (PD) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|12 Months|All participants.|||percentage of participants|||Number
1382771|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382772|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
1382773|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|2 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days."|||Participants|||Count of Participants
1382774|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|1 year|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 360 days or ITT subjects with follow-up of at least 330 days"|||Participants|||Count of Participants
1382775|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382776|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382914|NCT01434121|Secondary|Length of Time on Vasopressor Medication||during time of infusion - 96 hours from time of enrollment|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
1382777|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382778|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382779|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.~Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Late (>30 days to 1 year)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382780|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Subacute (>24 hours to 30 days)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382781|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable~Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Acute (0-24 hours)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382782|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382783|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
1382784|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382785|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382786|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382787|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1383227|NCT01430624|Secondary|PTSD Symptom Scale Self-Report (PSS-SR)|Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.|2 weeks prior to 6 week, 3 month, 6 month followup|Only includes those with complete scale score information|||units on a scale||Standard Deviation|Mean
1382788|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382789|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
1382790|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382791|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382792|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382793|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when any of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382794|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382795|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382796|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382797|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382798|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1392171|NCT01335867|Secondary|Measures of Cocaine and Alcohol Craving|Measures of cocaine and alcohol craving will be measured using the Minnesota Cocaine Craving Scale and the Penn Alcohol Craving Scale|8 weeks|||||||
1382799|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382800|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382801|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382802|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382803|NCT01435031|Secondary|Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382804|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382805|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382806|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382807|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382808|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382809|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382810|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382811|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382812|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382813|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1392172|NCT01335867|Primary|More Alcohol Abstinent Days and Fewer Heavy Drinking Days|The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.|8 weeks||||Days Heavy Drinking|||Number
1382815|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382816|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382817|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382818|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382819|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382820|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382821|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382822|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382823|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382824|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382825|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382826|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382827|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382828|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382829|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382830|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382831|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
1382832|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382833|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382834|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382835|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382836|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
1382837|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
1382838|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|2 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days."|||Participants|||Count of Participants
1382839|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382840|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382841|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
1382842|NCT01435031|Secondary|Percentage of Participants With Clinically Significant Perforation|Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT Set|||percentage of participants||95% Confidence Interval|Number
1382843|NCT01435031|Secondary|Resource Utilization: Contrast Volume||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.|||mL||Standard Deviation|Mean
1382844|NCT01435031|Secondary|Resource Utilization: Fluoroscopic Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.|||Minutes||Standard Deviation|Mean
1382845|NCT01435031|Secondary|Resource Utilization: Procedural Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.|||Minutes||Standard Deviation|Mean
1382846|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Multiple Crossing Techniques|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382847|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Sub Intimal Technique|Defined as device success and absence of in-hospital MACE with antegrade crossing technique.|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382848|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Kissing Wire Technique|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382849|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Reverse CART|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382850|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382851|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382852|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Knuckle Wire|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382853|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1382854|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Antegrade Crossing|Defined as device success and absence of in-hospital MACE with antegrade crossing technique.|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
1392173|NCT01335867|Primary|Number of Participants With a Reduction in Cocaine Use|The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples.|3 weeks||||participants|||Number
1382855|NCT01435031|Secondary|Percentage of Participants With Procedure Success|"Device success and absence of in-hospital MACE.~Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).~Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
1382856|NCT01435031|Secondary|Percentage of Participants With Device Success|Achievement of <50% diameter stenosis within the target lesion segment using assigned study device|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
1382857|NCT01435031|Secondary|Percentage of Participants With Change in TIMI Flow Grade: Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~TIMI Classification:~TIMI 0 No perfusion.~TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.~TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.~TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
1382858|NCT01435031|Secondary|Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~TIMI Classification:~TIMI 0 No perfusion.~TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.~TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.~TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
1382859|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment – in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||mm||Standard Deviation|Mean
1382860|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment – in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||mm||Standard Deviation|Mean
1382861|NCT01435031|Primary|Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO|"Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and;~Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and;~Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and;~Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|Angiographically Evaluable Subjects|||percentage of participants||95% Confidence Interval|Number
1382862|NCT01435031|Primary|Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)|"Successful recanalization of the CTO defined as:~Confirmation of placement of the guide wire in the distal true lumen (component 1)~Absence of in-hospital MACE, based on protocol MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.|||percentage of participants||95% Confidence Interval|Number
1382863|NCT01435031|Primary|Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)|"Successful recanalization of the CTO defined as:~Confirmation of placement of the guide wire in the distal true lumen (component 1)~Absence of in-hospital MACE, based on ARC MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.|||percentage of participants||95% Confidence Interval|Number
1382864|NCT01435031|Primary|Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.|||Participants|||Count of Participants
1382865|NCT01435031|Primary|Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.|||Participants|||Count of Participants
1382866|NCT01434823|Secondary|Daytime Intensivist Daily Sleep Duration|This will be the primary outcome of the Intensivist Sleep and Work sub-study.|Daily||||hours||Standard Deviation|Mean
1382867|NCT01434823|Secondary|Discharge Home From Hospital|Patients who were discharged from the hospital to their homes|Assessed up to 12 months||||participants|||Number
1382868|NCT01434823|Secondary|Re-admission to the MICU Within 48 Hours|The investigators will measure, in hours, the time spent from discharge from the MICU until a patient is re-admitted to the MICU during the same hospital stay.|From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months||||participants|||Number
1382869|NCT01434823|Secondary|In-hospital Mortality|Mortality will be assessed during each patient's stay in the hospital.|From time of admission to MICU to hospital discharge - assessed up to 12 months||||participants|||Number
1382870|NCT01434823|Secondary|MICU Mortality|Mortality will be assessed during each patient's stay in the MICU from admission to discharge|From time of admission to MICU until discharge from MICU - assessed up to 12 months||||participants|||Number
1382871|NCT01434823|Primary|MICU Length of Stay|Time from ICU admission to discharge|From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months||||hours||Inter-Quartile Range|Median
1382872|NCT01434693|Primary|Incidence of Adverse Events|Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms|6 mo|All patients who were randomized were treated according to the protocol and therefore were all included in the Safety Population.|||events|||Number
1382873|NCT01434680|Secondary|Number Of Subjects Reporting Solicited Local And Systemic Adverse Events|"Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV.~Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS."|From day 1 through day 7|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
1382874|NCT01434680|Secondary|Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set.|||Titers||95% Confidence Interval|Geometric Mean
1382875|NCT01434680|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
1382876|NCT01434654|Secondary|Cerebrospinal Fluid|To measure plateaux CSF ARV concentrations. This will identify the proportion of patients achieving levels of specific ARVs capable of inhibiting 95% of in vitro viral replication (IC95).|Baseline to 12 Months|Data presented for n=5 participants with detectable CSF ARV concentrations who had lumbar puncture at Baseline and 12 months. The pre-specified analysis was not conducted as nevirapine, raltegravir, and darunavir were the only ARVs detected in CSF, and of these, only nevirapine was detected above the minimum threshold (set at >50 ug/L).|||ug/L||Standard Error|Mean
1382877|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H20 as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.|||Ratio||Standard Error|Least Squares Mean
1382878|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), after a 12 month period of observation. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echo time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.|||Ratio||Standard Error|Least Squares Mean
1382879|NCT01434654|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, after a 12-month period of observation, between HIV positive patients taking antiretroviral regimens categorized as being either of high or low CNS penetration. To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, Standard Deviation=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Change from baseline Neuropsychological testing at 6 and 12 months|Modified intent-to-treat analysis. All enrolled participants were included aside n=2 low CNS penetrance with baseline data only (1 lost to follow-up, 1 withdrew before 6-months).|||Global neurocognitive z-score||Standard Error|Least Squares Mean
1382880|NCT01434641|Secondary|Rest/Stress Myocardial Count Density Ratio|"The rest and stress myocardial count densities are determined automatically using Evolution software on the GE Healthcare Xeleris Nuclear Medicine computer workstation. The ratio is calculated by simple division.~Please not that patient outcomes are NOT measured in this research protocol."|immediately following SPECT image processing (1 hour after the test)|||||||
1382881|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 16 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 16- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 16 minutes|Of the total 102 patients enrolled, additional 16-minute post-stress SPECT was performed on 37 patients.|||participants|||Number
1382882|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 12 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 12- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 12 minutes||||participants|||Number
1382883|NCT01434511|Secondary|Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382884|NCT01434511|Secondary|Anti-OBI-1 Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382885|NCT01434511|Secondary|Anti-human Factor VIII Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382886|NCT01434511|Secondary|Efficacy Assessment of OBI-1 in Participants With Anti-human Factor VIII Titers >30 Bethesda Units (BU)||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382887|NCT01434511|Secondary|Recovery and Elimination Rate Parameters of OBI-1 in Subjects With Inhibitors Treated With OBI-1 Therapy.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382888|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers and the Recovery of OBI-1.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382889|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode.||Frame: Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382890|NCT01434511|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382915|NCT01434121|Secondary|Ventilator-free Days||subject will be followed until discharged from the hospital, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
1382891|NCT01434511|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382892|NCT01434511|Secondary|Total Dose of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382893|NCT01434511|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382894|NCT01434511|Secondary|Proportion of Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382895|NCT01434511|Secondary|Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382896|NCT01434511|Primary|Proportion of Serious Bleeding Episodes Responsive to OBI-1|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, the study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within the OBI-1-302 study (Congenital Hemophilia A).|24 hours after initiation of treatment|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
1382897|NCT01434342|Primary|Adherence|Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm|24 weeks|All randomized participants|||Participants|||Count of Participants
1382898|NCT01434342|Primary|Feasibility of a Smoking Cessation Intervention Among Cancer Patients|The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.|24 Weeks|All randomized participants|||Participants|||Count of Participants
1382899|NCT01434290|Secondary|Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy|The biomarker data will not be obtained due to lack of funding.|Study entry to 5 years from the end of protocol treatment|||||||
1382900|NCT01434290|Secondary|Utilization of Sexual Medications/Devices Questionnaire Response Frequences|"The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The number of subjects responding Yes to the following questions are reported: Do you have a penile prosthesis, Have you used an medications or devices to aid or improve erections?. Arms are not compared to each other. One, 2, and 5 years will be entered when they are available."|Baseline and one year from the end of protocol treatment|Eligible patients who started study treatment and completed the questionnaire at baseline and the specified timepoint|||participants|||Number
1382901|NCT01434290|Secondary|Change From Baseline in EQ-5D Scores|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score. One, 2, and 5 years will be entered when they are available. Arms are not compared.|Baseline and one year from the end of protocol treatment|All eligible patients who started study treatment and completed the EQ-5D at baseline and the specified timepoint|||units on a scale||Inter-Quartile Range|Median
1382902|NCT01434290|Secondary|The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points|The percentage of patients with a reduction in the EPIC hormonal domain score from baseline that exceeds 3 points (baseline - one year > 3). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline and one year from the end of protocol treatment|Eligible patients who started study treatment and completed the specified domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
1394940|NCT01311024|Secondary|Carriage Due to Haemophilus Influenzae|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age|||||||
1382903|NCT01434290|Secondary|The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points|The percentage of patients with a reduction in the EPIC sexual domain score from baseline that exceeds 11 points (baseline - one year > 11). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline one year from the end of protocol treatment|Eligible patients who started study treatment and completed the specified domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
1382904|NCT01434290|Secondary|Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year|The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life and a positive change from baseline indicating improvement over time. For this endpoint, in each domain, the actual change score calculated as timepoint score - baseline score will be used as the statistic.|Baseline and one year from the end of protocol treatment|Eligible patients who started protocol treatment and completed the respective domain of the EPIC at baseline and one year|||units on a scale||Inter-Quartile Range|Median
1382905|NCT01434290|Secondary|Quality Adjusted Life Years at 5 Years Using the EQ-5D and DFS|Will be reported after five-year data has been obtained.|Registration to 5 years from the end of protocol treatment||2021-06-30|06/2021||||
1382906|NCT01434290|Secondary|Rate of Disease-free Survival (DFS)|The disease-free survival duration will be measured from the date of randomization to the date of documentation of disease progression or until the date of death from any cause. DFS will be estimated for each hypofractionated arm by the Kaplan-Meier method. One, 2, and 5 years will be entered when they are available. Arms are not compared to each other.|Registration to 1 year from the end of protocol treatment|Eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
1382907|NCT01434290|Secondary|Rate of PSA Failure|Failure occurs when the PSA is first noted to be 2 ng/mL or more than the current nadir value (PSA > current nadir + 2) post RT completion. Only one year results are shown. One, 2, and 5 years from the end of protocol treatment will be entered as they are available. Rate of PSA failure is estimated by the cumulative incidence method. Arms are not compared to each other.|Registration to one year from the end of protocol treatment|Eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
1382908|NCT01434290|Secondary|Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of radiation therapy (RT). The high dose RT arm of Radiation Therapy Oncology Group (RTOG) study RTOG-0126 (NCT00033631) reported 1% of patients experienced grade 3+ GI/GU acute toxicity with no patient experiencing a grade 4 or 5 toxicity. If the lower confidence interval is >1%, then that arm will be further investigated for acceptability. A late adverse event is defined as the first occurrence of worst severity of adverse event >30 days after RT completion. Arms are not compared to each other.|Start of protocol treatment to one year from the end of protocol treatment|Eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
1382909|NCT01434290|Primary|The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points|The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year > 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline and one year from the end of protocol treatment|Eligible patients who started protocol treatment and completed the urinary domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
1382910|NCT01434290|Primary|Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points|The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year > 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline and one year from the end of protocol treatment|Eligible patients who started protocol treatment and completed the bowel domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
1382911|NCT01434186|Primary|Mean Change in HbA1c From Baseline to Week 16||16 week short term treatment period||||percentage||Standard Deviation|Mean
1382912|NCT01434121|Secondary|Plasma Cytokine/Chemokine Levels||during time of infusions - 96 hours from time of enrollment|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
1382913|NCT01434121|Secondary|Multiple Organ Dysfunction Score||during time of infusion - 96 hours from time of enrollment|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
1383228|NCT01430624|Secondary|Non-medical Use of Prescription Drugs Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|2 participants had missing data at 6 month follow-up|||days of use||Standard Deviation|Mean
1382916|NCT01434121|Secondary|Duration of Mechanical Ventilation||subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 28 days from time of enrollment, whichever is first|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
1382917|NCT01434121|Secondary|Intensive Care Unit Length of Stay||subject will be followed until discharged from the ICU, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
1382918|NCT01434121|Primary|Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients|There were no instances of arterial hypotension, vomiting, or tachycardia within the study population related to the study drug|during time of infusion- 96 hours from time of enrollment||||participants|||Number
1382919|NCT01434030|Secondary|Willingness to Follow PGASystem Advice|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would follow this type of advice from a PGASystem.|2 hour focus group||||percentage of participants|||Number
1382920|NCT01434030|Primary|Desire to Receive Advice From Personal Glucose Advisory System (PGASystem)|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would like to receive this type of information from a PGASystem.|2 hour focus group||||percentage of participants|||Number
1382921|NCT01433978|Primary|Change From Baseline in Local Platelet Count for the 6 Month Treatment Period|Platelet responses to avatrombopag was evaluated using the platelet counts determined at local clinical laboratories. Only participants with non-missing data at both baseline and the relevant post-baseline visit are included in the change from baseline summary statistics. Standard deviation is not applicable for some of the categories, from Visit 14 to Visit 22, as the number of participants analyzed for that visit was 1 individual.|Day 5, Day 8, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 19, Week 20, Week 22, Week 23, Week 24, Week 25, Week 26|The Full Analysis Set (FAS) included all participants who were randomized into the study. Only participants with non-missing data at both baseline and the relevant post-baseline visit are included in the change from baseline summary statistics.|||cells x 10^9/L||Standard Deviation|Geometric Mean
1382922|NCT01433913|Secondary|Changes in Serum Fasting Glucose||Baseline and 12 weeks|Data were not collected because insulin is a more relevant outcome measure than glucose||||||
1382923|NCT01433913|Secondary|Changes in Serum SHBG||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
1382924|NCT01433913|Secondary|Changes in Serum Testosterone||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
1382925|NCT01433913|Secondary|Changes in Serum IGF-1/IGFBP-3||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
1382926|NCT01433913|Secondary|Changes in Serum Fasting Insulin||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
1382927|NCT01433913|Secondary|Changes in Serum PSA||Baseline and 12 weeks|Analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
1382928|NCT01433913|Secondary|Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Retinoblastoma Protein Phosphorylation (p-pRb)||12 weeks|Data were not collected due to budgetary constraints||||||
1382929|NCT01433913|Secondary|AMPK Activation in the Prostatectomy Tissue as Assessed by IHC of p-AMPK||12 weeks|Data were not collected due to budgetary constraints||||||
1382930|NCT01433913|Secondary|Angiogenesis in the Prostatectomy Tissue as Assessed by IHC of CD34||12 weeks|Data were not collected due to budgetary constraints||||||
1382931|NCT01433913|Secondary|mTOR Regulation in the Prostatectomy Tissue as Assessed by IHC of Phospho-p70 S6 Kinase (p-p70S6K)||12 weeks|Participants with tissue sections available from prostatectomy|||% positive cells||Inter-Quartile Range|Median
1382932|NCT01433913|Secondary|Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Cyclin D1||12 weeks|Participants with tissue sections available from prostatectomy|||% positive cells||Inter-Quartile Range|Median
1382933|NCT01433913|Secondary|Apoptosis Levels in the Prostatectomy Tissue as Assessed by IHC of Cleaved Caspase 3|Average number of positively stained cells that exhibited nuclear fragmentation from five randomly selected high-power fields (40x) in the tumor region was calculated for each participant|12 weeks|Participants with tissue sections available from prostatectomy|||Number of positive cells||Inter-Quartile Range|Median
1382934|NCT01433913|Secondary|Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry||12 weeks|analysis limited to patients with fresh frozen prostatectomy tissue|||ug/g tissue||Inter-Quartile Range|Median
1382935|NCT01433913|Primary|Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)|Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. If the data are not normally distributed, a non-parametric rank-sum test will be utilized.|12 weeks|Participants with tissue sections available from prostatectomy|||% positively stained nuclei||Inter-Quartile Range|Median
1382936|NCT01433731|Primary|Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)|Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% – 99% decrease in CAILS score; Stable Disease (SD): < 25% increase to < 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.|Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42||||percentage of participants|||Number
1382937|NCT01433549|Secondary|Mean Non-Invasive Tear Film Break-Up Time (NITBUT)|As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.|Hour 12|All participants who participated in both phases of the study.|||Seconds||Standard Deviation|Mean
1382938|NCT01433549|Primary|Mean End-of-Day Comfort|As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.|Hour 12|All participants who participated in both phases of the study.|||Units on a scale||Standard Deviation|Mean
1382939|NCT01433471|Secondary|Change From Baseline of the Simple Clinical Colitis Activity Index at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 Weeks|To assess ulcerative colitis disease activity without requiring endoscopy|Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
1382940|NCT01433471|Secondary|Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks|To assess ulcerative colitis disease activity|Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
1382941|NCT01433471|Primary|Change From Baseline of Gene Expression at 12 Weeks and 24 Weeks as Assessed by Microarray and Real-time Polymerase Chain Reaction Analysis of Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
1382942|NCT01433471|Primary|Change From Baseline of Bacterial Composition and Attachment at 12 Weeks and 24 Weeks as Assessed by Real-time Polymerase Chain Reaction and 454 Sequencing of Pinch Biopsies and Stool Specimens||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
1382943|NCT01433471|Primary|Change From Baseline of Effector Lymphocyte Populations (Th1, Th2, Th17, and T-regulatory Cells) at 12 and 24 Weeks as Assessed by Flow Cytometry of Peripheral Blood Mononuclear Cells and Isolated Leukocytes From Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
1382944|NCT01433471|Primary|Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
1382945|NCT01433354|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which participants entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study.~AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 participants are shown under ‘Prior to Ext. first dose’.~AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated."|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1382946|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in time (minutes)||Standard Deviation|Mean
1382947|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in time (minutes)||Standard Deviation|Mean
1383229|NCT01430624|Primary|Marijuana Use Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up||||days of use||Standard Deviation|Mean
1394941|NCT01311024|Secondary|Carriage Due to Any Pneumococcal Serotype|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age|||||||
1382948|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in time (minutes)||Standard Deviation|Mean
1382949|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in number of steps||Standard Deviation|Mean
1382950|NCT01433263|Secondary|Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8|||Percentage Change in BMD||Standard Deviation|Mean
1382951|NCT01433263|Secondary|Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8|total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8|||Percentage Change in LBM||Standard Deviation|Mean
1382952|NCT01433263|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||hr||Inter-Quartile Range|Median
1382953|NCT01433263|Secondary|Maximum Observed Serum Concentration (Cmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||ng/ml||Standard Deviation|Mean
1382954|NCT01433263|Secondary|Percentage Change in Body Weight From Baseline at Week 7 and Week 9|Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9|Baseline, Week 7 and Week 9|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||Percent Change of Weight (kg)||Standard Deviation|Mean
1382955|NCT01433263|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.|Baseline, week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8|||Percentage Change of TMV||Standard Deviation|Mean
1382956|NCT01433250|Secondary|Measure of Disability: Expanded Disability Status Scale (EDSS).|The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.|Baseline to week 97|Not all patients may have been available at all time points for EDSS evaluation|||participants|||Number
1382957|NCT01433250|Secondary|Change in Brain Volume at End of Study.|Change in volume from start to end of study|week 97||||ml||Standard Deviation|Mean
1382958|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions|weeks 13,25,37,53,73 and 97||||lesions||Full Range|Mean
1382959|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans|weeks 13,25,37,53,73 and 97||||lesions||Full Range|Mean
1382960|NCT01433250|Secondary|Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)|Description: number of relapses based on neurological assessments and EDSS|week 97||||Participants|||Number
1382961|NCT01433250|Primary|Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments|Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome|97 weeks||||participants|||Number
1382962|NCT01433172|Secondary|Response Rate|Response according to Response Evaluation in Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; No new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. Progressive Disease (PD): 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration; All target measurable lesions must be assessed using the same techniques as baseline.|Up to 12 Months|All Phase II participants|||Participants|||Count of Participants
1382963|NCT01433172|Primary|Phase II: Progression Free Survival (PFS)|PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|Up to 6 Months|A Phase II participants evaluable at time of analysis.|||months||95% Confidence Interval|Median
1382964|NCT01433172|Primary|Phase I: Recommend Phase II Dose (RPDII)|Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component.|Up to 6 Months|All Phase I Participants|||Recommend Phase II Dose Level|||Number
1382965|NCT01433159|Primary|Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score|"Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores.~Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound >24 cm x cm, containing necrotic tissue, with heavy exudate)"|baseline, 14 Days|Per Protocol Population|||scores on a scale||Standard Deviation|Least Squares Mean
1382966|NCT01433107|Secondary|Number of Subjects With Adverse Event|Number of Subjects with adverse event|6 weeks|Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.|||participants|||Number
1382967|NCT01433107|Secondary|Total Clinical Signs and Symptoms (S/S) Scores|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:~0 = absent~= mild~= moderate~= severe In order to calculate the total symptom score, the scores for each individual symptom are added up.~Possible range : 0 to 18"|week 6||||units on a scale||95% Confidence Interval|Mean
1382968|NCT01433107|Primary|Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:~0 = absent~= mild~= moderate~= severe In order to calculate the total symptoms score the rating for all symptoms are added up.~Possible range 0 to 18"|week 6|Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).|||participants|||Number
1382969|NCT01433081|Secondary|Opioid Consumption|Opioid consumption after discharge|24 hours||||miligram morphine equivalents||Inter-Quartile Range|Median
1382970|NCT01433081|Primary|Quality of Recovery Scores Post Operative|Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).|24 hours post operative|Two drop outs for either arm were removed from analysis.|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Mean
1382971|NCT01433055|Secondary|The Effect of Adjunct Minocycline to Placebo on Global Clinical Improvement of Symptoms.|The Clinical Global Impression Severity score will be used to examine the effect of minocycline compared to placebo. This assessment has 2 items (scored 0-7) with a total minimum socre of 0 and maximum score of 14. The lower the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
1382972|NCT01433055|Secondary|The Effect of Adjunct Minocycline to Placebo to Improve Depressive Symptoms as Measured by the Calgary Depression Scale|The total score of the Calgary Depression Rating Scale will be used to examine the efficacy of minocycline compared to placebo in improving depressive symptoms. This assessment has 9 items (scored 0-3) with a total minimum socre of 0 and maximum score of 27. The lower the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
1382973|NCT01433055|Secondary|The Effect of Minocycline Compared to Placebo to Improve Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS)|Adjunct minocycline will be compared to placebo to test its efficacy in improving negative symptoms of schizophrenia. The Scale for the Assessment of Negative Symptoms (SANS) will be used to test changes in the total SANS score in adjunct minocycline compared to placebo in the 10 week study. This assessment has 22 items (scored 0-5) with a total minimum score of 0 and maximum score of 110. The lower the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
1382974|NCT01433055|Primary|Effect of Minocycline on Cognitive Symptoms as Measured by the MATRICS Consensus Cognitive Battery.|Adjunct minocycline will be compared to placebo to test its efficacy in improving cognitive function. Neuropsychological testing will be done at baseline and endpoint using the MATRICS battery. A composite score as well as individual scores will be will be the primary outcome over the 10 week randomized study. This assessment total minimum score of -10 and maximum score of 80. He higher the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
1383230|NCT01430624|Primary|Amount of Alcohol Use|estimated number of drinks during the 14 days prior to each follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|1 participant with missing data at 6 week follow-up|||Drinks||Standard Deviation|Mean
1382975|NCT01433055|Primary|Brief Psychiatric Rating Scale (BPRS) Positive Symptom Domain Scores Between Minocycline and Placebo.|Adjunct minocycline to clozapine will be compared to placebo to test its efficacy to improve positive psychotic symptoms. The 4 item positive sub factor of the Brief Psychiatric Rating Scale (BPRS) will be the primary outcome over the 10 week randomized study. Total maximum score is 28, and total minimum score is 4. The positive domain score consists of conceptual disorganization (item 4), suspiciousness (item 11) hallucinatory behavior (item 12), and unusual thought content (item 15). All data is reported as the difference between baseline and 10 weeks. The lower the score the better the outcome.|10 Weeks|The BPRS is a scale that measures major psychotic and non psychotic symptoms in persons with psychotic disorders. It is an 4 item scale with a score range of 1-7 on each item. Results are reported as total score. Total maximum score is 28, and total minimum score is 4.|||units on a scale||Standard Deviation|Mean
1382976|NCT01433042|Primary|Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians|precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians|up to 6 months from end of recruitment|"Five (2%) cases were excluded from the efficacy analysis due to the following :~1 patient withdrawn prior to any procedure.~1 patient did not meet the inclusion criteria~3 cases, the capsule remained in the stomach during the entire procedure.~Therefore, 220 cases are included in the efficacy analysis."|||percentage of cases|||Number
1382977|NCT01433016|Primary|PDR Peak|PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.|At study day one after one hour||||percentage of dose recovery||Standard Deviation|Mean
1382978|NCT01432938|Secondary|Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax) of Warfarin|Observed INRmax was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least 1 dose of warfarin with evaluable warfarin INR data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1382979|NCT01432938|Secondary|Pharmacodynamics: Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin|AUCINR was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin INR data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1382980|NCT01432938|Primary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.|||hours||Full Range|Median
1382981|NCT01432938|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1382982|NCT01432938|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin|Area under the concentration versus time curve (AUC) from zero to infinity was determined from plasma concentrations of the S- and R- enantiomers of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.|||nanograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
1382983|NCT01432886|Primary|Number of Participants With Adverse Events|The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years|The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation.|||Participants|||Number
1382984|NCT01432886|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.|Up to 3 weeks|The DLT analysis set included those participants who received at least one dose of study drug and had a DLT assessment in cycle 1 (3 weeks) without deviations from the eribulin mesylate/trastuzumab dosing regimens and other major protocol prescripts. Participants with a DLT, regardless of this criterion, were also included in the DLT analysis set.|||Participants|||Number
1382985|NCT01432756|Primary|Number of Topics Discussed Between Parent and Child|"Measured using the Parent-Child Communication Scale (communication on sexual and HIV topics that the intervention covers) for both parent and child participants in pre- and post-assessments. This is a measurement of the number of sex and HIV topics discussed. 16 topics were assessed, including how women get pregnant, how to use condoms to prevent pregnancy and HIV, and how to recognize sexual pressure.~For each topic, participants answered yes or no if they discussed it, and then rate between 1-16 to indicate their communication (higher scores mean better communication). The total scores is reported as the sum of the 16 items, and can range from 0-16."|6 months|Each dyad consisted of one parent and their adolescent child. Sixty-six parents and 66 adolescents participated.|||number of sex and HIV topics discussed||Standard Deviation|Mean
1383231|NCT01430624|Secondary|Any Other Illicit Drug Use|Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up|14 days prior to 6 week, 3 month, 6 month follow-up||||participants|||Number
1382986|NCT01432626|Primary|Number of Participants Who Had an Abnormal Regional Uptake of I-123 mIBG at Baseline (Acute Phase) and the Number of Participants Who Had an Abnormal I-123 mIBG Uptake on Follow up (Recovery Phase)|Number of participants who had an abnormal regional uptake of I-123 mIBG at baseline (acute phase) and the number of participants who had an abnormal I-123 mIBG uptake on follow up (recovery phase)|During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks)||||participants|||Number
1382987|NCT01432600|Secondary|Phase II - Occurrence of Possibly Related Adverse Events (AEs)|Phase II: Participants with Grade 3 or 4 adverse events at least possibly related to the study treatment in 5% of participants in the Phase 2 portion, by AE category, assessed by the National Cancer Institute Common Terminology Criteria (NCI CTC) version 4.0.|Up to 48 Months|All Phase II Participants who completed allocated intervention.|||percentage of participants|||Number
1382988|NCT01432600|Secondary|Phase II - Median Overall Survival (OS)|Overall survival per treatment arm. Overall survival is defined as the time from start of treatment to death of any cause.|36 Months|All participants assigned to Arm B and Arm C.|||months||95% Confidence Interval|Median
1382989|NCT01432600|Secondary|Phase II - Median Progression Free Survival (PFS)|Progression free survival per treatment arm. Progressive Disease (PD) requires one of the following, increase of greater than or equal to 25% from baseline in: Serum M-component; Urine M-component; The difference between involved and uninvolved sFLC levels; The size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia.|36 Months|All Phase II Participants.|||months||95% Confidence Interval|Median
1382990|NCT01432600|Primary|Phase II - Overall Response Rate (ORR)|Overall response, Minimal Remission (MR) or better per treatment arm, using the uniform response criteria by the International Myeloma Working Group (IMWG) of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in participants with relapsed and refractory myeloma. In addition, Minimal response was incorporated in those response criteria as this is a valid endpoint in patients with relapsed or refractory myeloma. MR: 25-49% reduction in serum paraprotein and a 50-89% reduction in urine light chain excretion; A 25-49% reduction in the size of soft tissue plasmacytoma must be demonstrated is applicable.|36 Months|All Phase II Participants.|||percentage of participants||95% Confidence Interval|Number
1382991|NCT01432600|Primary|Phase I - Maximum Tolerated Dose (MTD)|The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity related to treatment with pomalidomide or cyclophosphamide; Participants must have received optimal symptomatic treatment for Grade 3 or 4 nausea, vomiting, or diarrhea to be considered a DLT; Grade 4 transaminitis; Grade 3 transaminitis must be present for ≥ 7 days to be considered a DLT; Grade 4 thrombocytopenia for 7 or more days; Grade 4 neutropenia for 7 or more days.|28 Days|All Phase I Participants.|||mg|||Number
1382992|NCT01432574|Secondary|Change in Antibody Titers|Change in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) were calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution.|Points: Day 1 and Month 7|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.|||mMU/mL (geometric mean titer)||95% Confidence Interval|Geometric Mean
1382993|NCT01432574|Primary|Percentage of Participants Seropositive at Month 7|Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7.|7 Months|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.|||percentage of participants|||Number
1382994|NCT01432561|Primary|Time to Peak Plasma Cysteamine Concentration (Tmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose||||minutes||Standard Deviation|Mean
1382995|NCT01432561|Primary|Peak Plasma Cysteamine Concentration (Cmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose||||uM||Standard Deviation|Mean
1382996|NCT01432561|Primary|Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose||||min*uM||Standard Deviation|Mean
1383232|NCT01430624|Primary|Cigarettes (Estimated Number)|quantity in 14 days prior to 6 week, 3 month and 6 month follow-up|14 days preceding 6 week, 3 month and 6 month follow-up|1 participant missing 6 week cigarette smoking information|||cigarettes||Standard Error|Mean
1382997|NCT01432535|Primary|Apparent Volume of Distribution (Vd/F)|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||Liters||95% Confidence Interval|Geometric Mean
1382998|NCT01432535|Primary|Apparent Total Body Clearance (CL/F)|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||mL/min||95% Confidence Interval|Number
1382999|NCT01432535|Primary|Apparent Terminal Half-life (T1/2)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1383000|NCT01432535|Primary|Time to Maximum Observed Serum Concentration (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||hours||95% Confidence Interval|Median
1383001|NCT01432535|Primary|Maximum Observed Serum Concentration (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||pg/mL||95% Confidence Interval|Geometric Mean
1383002|NCT01432535|Primary|AUC From Time 0 to the Last Measurable Sample (AUC0-last)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||pg*hr/mL||95% Confidence Interval|Least Squares Mean
1383003|NCT01432535|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||pg*hr/mL||95% Confidence Interval|Least Squares Mean
1383004|NCT01432457|Secondary|Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score|"The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.~Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function."|Baseline to Week 8 (final on-therapy)|Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline.|||Units on a scale||Standard Error|Mean
1383005|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.|Baseline to week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used.|||percentage of the number of participants|||Number
1383006|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used.|||percentage of the number of participants|||Number
1383007|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.|||Units on scale||Standard Error|Mean
1383008|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate.|||Units on scale||Standard Error|Mean
1383009|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data.|||number of participants|||Number
1383010|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.|||Units on a scale||Standard Error|Mean
1383011|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.|||Units on a scale||Standard Error|Mean
1383012|NCT01432444|Secondary|Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.|The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Week 4, 12 and 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
1383013|NCT01432444|Secondary|Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).|The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
1383014|NCT01432444|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
1383015|NCT01432444|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
1383016|NCT01432444|Secondary|Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210.|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
1383017|NCT01432444|Primary|Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).|Retrospective period Months 4-6; Prospective period Months 4-6|The core dataset for all efficacy analyses is the Intent-to-Treat (ITT) dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||participants|||Number
1383018|NCT01432405|Secondary|Plasma Adipocytokines|the effect of the intervention on plasma adiponectin levels.|one year||||microgram per ml||Standard Error|Mean
1383019|NCT01432405|Primary|Hepatic Fat|The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.|one year||||percent of liver fat||Standard Error|Mean
1383020|NCT01432379|Secondary|Incidence Rate of Intractable Migraine|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A|||events per 1,000 person-months||95% Confidence Interval|Number
1383021|NCT01432379|Primary|Incidence Rate of Dysphagia|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A|||events per 1,000 person-months||95% Confidence Interval|Number
1383022|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline|Correlation between BMQ concerns score and participant’s characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants’ beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant’s characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.|||correlation coefficient||95% Confidence Interval|Number
1383023|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline|Correlation between BMQ necessity score and participant’s characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants’ beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant’s characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.|||correlation coefficient||95% Confidence Interval|Number
1383024|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity–concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost–benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.|||correlation coefficient||95% Confidence Interval|Number
1383025|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity–concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost–benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.|||correlation coefficient||95% Confidence Interval|Number
1383026|NCT01432366|Secondary|Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline, Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||percentage of participants|||Number
1383027|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||percentage of participants|||Number
1383028|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline|BMQ consists of two 5-item scales assessing participants’ agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items.|||percentage of participants|||Number
1383029|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety|Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at each specified time point.|||correlation coefficient||95% Confidence Interval|Number
1383030|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||correlation coefficient||95% Confidence Interval|Number
1383031|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety|Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||correlation coefficient||95% Confidence Interval|Number
1383119|NCT01431521|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The AST Population consists of all participants who received at least one dose of the study drug.|||Participants|||Number
1383032|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||correlation coefficient||95% Confidence Interval|Number
1383033|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12|Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
1383034|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12|Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant’s concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
1383035|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12|Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
1383036|NCT01432366|Primary|Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12|Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant’s beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 [very well] to 100 millimeter (mm) [extremely bad]). DAS28 less than or equal to (<=) 3.2=low DA; greater than (>) 3.2 to <=5.1=moderate DA; >5.1=high DA; <2.6=remission.|Month 12|Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
1383037|NCT01432327|Secondary|Step Count|Daily number of steps|One Year|||||||
1383038|NCT01432327|Secondary|Stages of Motivational Readiness for Physical Activity|According to The Stages of Motivational Readiness for Change Model (SOC), individuals move through a series of stages as they adopt and maintain a new habit(Prochaska & DiClemente, 1983). Specifically, the stages include Precontemplation, Contemplation, Preparation, Action, and Maintenance.The relevant variables were assessed in a self-administered questionnaire.|One Year|||||||
1383039|NCT01432327|Secondary|Percent of Participants Losing Fat Percentage|The amount of body fat is measured by bioelectrical impedance analysis (BIA).|One Year|||||||
1383040|NCT01432327|Secondary|Daily Energy Expenditure in Physical Activity|Minutes of physical activity. Activities can be classified as moderate-intensity, vigorous-intensity or very vigorous-intensity activities based upon the amount of energy used by the body while doing the activity.|One year|||||||
1383120|NCT01431521|Primary|Number of Participants Experiencing One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 10 weeks|All Subjects as Treated (AST) Population consists of all participants who received at least one dose of the study drug.|||Participants|||Number
1383041|NCT01432327|Primary|Physical Activity Level|To account for differences in body size and composition, the 24-hour energy requirement (kcal/day) is expressed as a multiple of the basal metabolic rate per 24 hours by using the PAL value (PAL = total energy expenditure/basal metabolic rate). A desirable PAL includes the regular practice of physical activity at work or in spare time with an intensity and duration that will reduce the risk of becoming overweight and developing a variety of non-communicable chronic diseases usually associated as co-morbidities with obesity. This corresponds to PAL values of 1.75 and higher.|One year|Intention to treat analysis was used and analyses data from all participants, including those who did not complete the study|||Metabolic Equivalent||Standard Deviation|Mean
1383042|NCT01432275|Secondary|Preference Questionnaire (Insulin Calculator Not Activated)|"Result for the question: The meter the subject would change to"|25 days (results recorded after the two 7 day periods)|Subjects used a comparator blood glucose meter for 7 days and a FreeStyle InsuLinx meter for 7 days (insulin calculator deactivated). Subjects then completed a preference questionnaire. Each subject was assigned one of the three competitor systems. Subjects had not previously used either study device. Analysis per protocol.|||participants|||Number
1383043|NCT01432275|Primary|Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.|Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.|25 days|A comparator blood glucose meter was used for 7 days and a FreeStyle InsuLinx for 7 days (insulin calculator inactive). For the last 10 days a FreeStyle InsuLinx with the insulin calculator activated was used. Each subject was assigned one of the three competitor systems. Subjects had not previously used any study systems. Analysis per protocol.|||participants|||Number
1383044|NCT01432262|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination|Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result, received no prohibited vaccines, and had no other major protocol violations. Here “N” signifies participants with valid and determinate assay results at both pre-vaccination and post-vaccination.|||fold rise||95% Confidence Interval|Geometric Mean
1383045|NCT01432262|Secondary|Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1383046|NCT01432262|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 1 Month (28 to 42 days) after vaccination|Safety Population included all participants who received the vaccine.|||percentage of participants||95% Confidence Interval|Number
1383047|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in >1 category.|||percentage of participants||95% Confidence Interval|Number
1383048|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in >1 category.|||percentage of participants||95% Confidence Interval|Number
1383077|NCT01431989|Primary|Time of Maximum Observed Concentration (Tmax)|The time of maximum observed concentration (Tmax) is obtained directly from the plasma concentration curve of the drug by non-compartimental method. Tmax is of particular use in measuring bioavailability, by measuring the time at which the maximum concentration is achieved.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||hr||Standard Deviation|Mean
1383049|NCT01432262|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.|One month (28 to 42 days) after vaccination|Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1383050|NCT01432236|Other Pre-specified|Health Utilization Assessment (Time for Help no Payment) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. 'Time for help no payment' refers to time other people spent without receiving payment to help with activities the patient cannot perform due to fibromyalgia.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Hours||Standard Deviation|Mean
1383051|NCT01432236|Other Pre-specified|Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Visits||Standard Deviation|Mean
1383052|NCT01432236|Other Pre-specified|Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline.|WPAI-SHP assessed work productivity and impairment. It was a participant-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past 7 days. Subscale scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Each subscale score was expressed as an impairment percentage (0-100) where higher numbers indicated greater impairment and less productivity.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1383053|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline.|C-SSRS assessed whether participant experienced following:completed suicide (1), suicide attempt (2) (response of Yes on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (Yes on “preparatory acts or behavior”), suicidal ideation (4) (Yes on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on “Has subject engaged in non-suicidal self-injurious behavior”). Below table indicated one participant (10141023) treated with Pregabalin reported preparatory act. However upon study unblinding it was clarified that preparatory act occurred while the participant was taking placebo. Since preparatory act was reported at first visit of Period 2, by convention statistical summaries classified this under Pregabalin treatment.|From Visit 3 to Visit 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Participants|||Number
1383054|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline.|C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3) (“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Participants|||Number
1383055|NCT01432236|Other Pre-specified|Mean PSGA Score at End of Period.|PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point numeric rating scale (NRS) ranging from 0 (very poor) to 10 (very good).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1383056|NCT01432236|Other Pre-specified|Mean Patient Static Global Assessment (PSGA) Score at Baseline.|PSGA was a single-item self-rated instrument that measured the participant’s overall status on an 11-point NRS ranging from 0 (very poor) to 10 (very good).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1383057|NCT01432236|Secondary|EQ-5D Score at End of Period.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1383058|NCT01432236|Secondary|Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1383059|NCT01432236|Secondary|HADS at End of Period.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1383060|NCT01432236|Secondary|Hospital Anxiety and Depression Scale (HADS) at Baseline.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1383061|NCT01432236|Secondary|Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Number of times awakened||Standard Error|Least Squares Mean
1383062|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Minutes||Standard Error|Least Squares Mean
1383063|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Minutes||Standard Error|Least Squares Mean
1383064|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Minutes||Standard Error|Least Squares Mean
1383065|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.|Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1383066|NCT01432236|Secondary|Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.|Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period.|Visits 2, 6, and 12|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Percentage of participants|||Number
1383067|NCT01432236|Other Pre-specified|PGIC at the End of Period 2.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Because of the crossover design and PGIC recall period (since starting study medication), the Period 1 PGIC data were felt to provide the clearest comparison across treatments, whereas Period 2 PGIC data were felt to have a more complex interpretation. Thus PGIC at End of Period 2 was separately analyzed from PGIC at End of Period 1.|End of Period 2 at Week 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Percentage of Participants|||Number
1383068|NCT01432236|Secondary|Patient Global Impression of Change (PGIC) at the End of Period 1.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|End of Period 1 at Week 6|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Percentage of participants|||Number
1383069|NCT01432236|Secondary|FIQ Score at End of Period.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study.|||Units on a scale||Standard Error|Least Squares Mean
1383070|NCT01432236|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1383071|NCT01432236|Primary|Mean NRS Pain Score at End of Period.|The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 (“no pain”) to 10 (“worst possible pain”). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1383072|NCT01432015|Primary|Overall Complete Response Rate|no emetic episodes or rescue therapy following the initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).|||percentage of participants|||Number
1383073|NCT01432015|Secondary|Impact on Daily Living Activities|Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).|||percentage of participants|||Number
1383074|NCT01431989|Primary|First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)|This parameter is estimated via linear regression of time versus log concentration. It allows for the obtainment of estimates of T1/2 (T1/2=ln(2)/Kel) considering the schedule and the detection limits defined.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||1/hr||Standard Deviation|Mean
1383075|NCT01431989|Primary|Terminal Half-life (T1/2_Kel)|T1/2_Kel is calculated by using the formula T1/2_Kel = Ln(2)/Kel.T1/2 is of particular use in measuring bioavailability, by measuring the elimination of the product.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||hr||Standard Deviation|Mean
1383076|NCT01431989|Primary|Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC_%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter is to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t) Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||percentage||Standard Deviation|Mean
1383103|NCT01431755|Primary|Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.|When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).|When injection of both cheeks were completed|Intention to treat. 54/54 subjects|||percentage of participants||95% Confidence Interval|Number
1383078|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)|Measurement of AUC0-inf is obtained directly from the plasma concentration curve of drug against time (non-compartmental method). AUC0-inf is calculated from time 0 (prior to administration of medication) extrapolated to infinity, by using the formula AUC0-inf = AUC0-t + Clast/Kel, where Clast is the last measurable concentration, and Kel is the first-order rate constant associated with the terminal portion of the curve. AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1[Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||ng*hr/mL||Standard Deviation|Mean
1383079|NCT01431989|Primary|Maximum Observed Concentration of Drug Through Time (Cmax)|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Measurement is obtained directly from the plasma concentration curve of the drug (non-compartmental method).|Collection points (hrs): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||ng/mL||Standard Deviation|Mean
1383080|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)|The area under the plot of plasma concentration of drug against time (non-compartmental method), after drug administration, is defined as the area under the curve (AUC). AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; mL, milliliter.|Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||ng per hour per ml (ng*hr/mL)||Standard Deviation|Mean
1383081|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Extension Phase (ExP) Overall|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided.|Extension Week 12 (Extension Visit 1 [Ext-V1], every 12 week after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Days||Standard Deviation|Mean
1383082|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Main Study Phase (Fixed Escalation Phase [FEP], Escalation Phase [EP], Maintenance Phase [MP]), and FEP+EP+MP)|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title)|Up to Study Week 50|FAS|||Days||Standard Deviation|Mean
1383083|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Assessment Point in the Extension Phase (ExP)|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the ExP, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 24 (Extension Visit 2 [Ext-V2], every 24 weeks after the Ext-V2 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Participants|||Number
1383084|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Each Assessment Point in the Extension Phase (ExP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 12 (Extension Visit 1 [Ext-V1]), every 24 weeks after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Participants|||Number
1383085|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs During Week 4 and Week 8 of the Maintenance Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Maintenace Phase, HV-clinical signs were assessed at Visit 1 (Week 4) and Visit 2 (Week 4).|Week 4 and Week 8 of the Maintenance Phase (up to Study Weeks 42 and 46, respectively)|FAS. Only those participants who were dosed with investigational product at the indicated time points were analyzed.|||Participants|||Number
1383086|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Escalation Phase, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Up to Study Week 49|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Participants|||Number
1401918|NCT01248715|Primary|Number of Participants That Required Re-hospitalization|Participants that were re-hospitalized within 30 days after enrollment.|30 days||||Participants|||Count of Participants
1383087|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them.|Up to Study Week 49|FAS|||Participants|||Number
1383088|NCT01431976|Primary|Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain’s electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes using a pin-wheel provided to them.|Week 12 of the Maintenance Phase (up to Study Week 50)|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and contributed data to at least one efficacy measure after the first dosing of investigational product|||Participants|||Number
1383089|NCT01431963|Secondary|Time to the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)|The time to the first seizure in the Maintenance Phase is measured at the time the first seizure occurred in the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|FAS. Only those participants available at the specified time point were analyzed.|||Days||Standard Error|Mean
1383090|NCT01431963|Secondary|Time to Withdrawal/Dropout From the Study (Across Seizure Types and by Seizure Type in Past 6 Months in the Escalation and Maintenance Phases)|Time to withdrawal is defined as the time from the start of treatment until withdrawal from the study. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures which affect only a small region of the brain, often the temporal lobes or hippocampi. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|up to Week 30|FAS. Only those participants available at the specified time point were analyzed.|||Days||Standard Error|Mean
1383091|NCT01431963|Primary|Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study)|Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic–clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|Full Analysis Set (FAS): all participants in the Safety Population (SP) who provided at least one set of efficacy data after the first dosing of investigational product. The SP is comprised of all participants who had taken at least one dose of investigational product. Only those participants available at the specified time point were analyzed.|||participants|||Number
1383092|NCT01431950|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1383093|NCT01431950|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
1396063|NCT01300286|Secondary|Fresh Frozen Plasma Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||mL||Inter-Quartile Range|Median
1383094|NCT01431950|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1383095|NCT01431950|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1383096|NCT01431950|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
1383097|NCT01431846|Primary|See Primary Outcome Description Below|Follow up appointment within 2 weeks of discharge back to their primary care providers at a primary care facility from a tertiary referral center.|Within 2 weeks of discharge||||participants|||Number
1383098|NCT01431755|Secondary|Number of Subjects Reporting Adverse Event|"Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.~All subjects were injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek."|Up to 12 months|Safety population, 54 subjects.|||participants|||Number
1383099|NCT01431755|Secondary|Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.|A subject diary was completed for 14 days following the initial treatment and the optional re-treatment at the 3-month visit. Each subject was asked to record the presence of bruising, redness, swelling, pain, tenderness and itching.|14 days|Safety Population. 54/54 subjects.|||participants|||Number
1383100|NCT01431755|Secondary|Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks|The severity of midface volume loss or midface contour deficiency was assessed by the investigators using a 4-graded scale, Medicis Midface Volume Scale -MMVS (1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing). Each score were exemplified by photographic images on the scale. A one grade decrease in score from screening was defined as a treatment success/improvement.The efficacy in terms of Medicis Midface Volume Scale (MMVS) was assessed by the Investigator per treatment group. The two cheeks were evaluated separately. MMVS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects|||percentage of participants||95% Confidence Interval|Number
1383101|NCT01431755|Secondary|Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)|Esthetic improvement was evaluated by using Global Esthetic Improvement Scale. GEIS was evaluated by comparing current photos with pre-treatment photos and using a 5-graded scale (worse/no change/somewhat improved/much improved/very much improved). A clinically significant global esthetic improvement was defined as a score of somewhat improved, much improved or very much improved. GEIS was assessed by the Investigator and the subject. Each cheek/study product was evaluated separately. GEIS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects|||percentage of participants||95% Confidence Interval|Number
1383102|NCT01431755|Secondary|Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.|"Pain was assessed during the first 2 hours after the initial injection of the study products using a 100 mm VAS. The endpoints of the scale were no pain (0 mm) and worst possible pain (100 mm). Pain was assessed at the time points 15, 30, 60, 90 and 120 minutes after injection."|15 and 120 minutes|Intention to treat. 54/54 subjects|||units on a scale||Standard Deviation|Mean
1385449|NCT01402011|Secondary|Nine Month Satisfaction Questionnaire|Phone call asking how satisfied were they with their treatment 10 = extremely satisfied, 0 = extremely dissatisfied )|Nine months after first injection treatment appointment||||units on a scale||Standard Deviation|Mean
1383105|NCT01431716|Other Pre-specified|Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question global satisfaction scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
1383106|NCT01431716|Other Pre-specified|Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question convenience scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
1383107|NCT01431716|Other Pre-specified|Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question effectiveness scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
1383108|NCT01431716|Other Pre-specified|Change in N-terminal Pro-B-type Natriuretic Peptide (NT proBNP) From Baseline to EOT.|Blood sampling for NT proBNP was performed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||ng/L||Standard Deviation|Mean
1383109|NCT01431716|Other Pre-specified|Number of Participants With Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) From Baseline to EOT.|NYHA FC was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. Disease severity was assessed by NYHA classification of pulmonary arterial hypertension criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||participants|||Number
1383110|NCT01431716|Other Pre-specified|Change in Borg Dyspnea Score From Baseline to EOT.|"The Borg dyspnea score was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labelled extremely severe, or the worst possible dyspnea imaginable."|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
1383111|NCT01431716|Primary|Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||L/min/m^2||Standard Deviation|Mean
1383112|NCT01431716|Primary|Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.|||mmHg||Standard Deviation|Mean
1383113|NCT01431716|Primary|Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||mmHg||Standard Deviation|Mean
1383114|NCT01431716|Primary|Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||mmHg||Standard Deviation|Mean
1383115|NCT01431716|Primary|Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||dyn/sec/cm^5||Standard Deviation|Mean
1383116|NCT01431716|Other Pre-specified|Change in 6-minute Walk Distance (6MWD) From Baseline to EOT.|The 6MWD was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The 6-minute walk test is a non-encouraged test that measures the distance walked for the duration of 6 min.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||m||Standard Deviation|Mean
1383117|NCT01431716|Primary|Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.|||dyn/sec/cm^5||Standard Deviation|Mean
1383118|NCT01431703|Primary|Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions||For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.||||percentage of lesions||95% Confidence Interval|Number
1385626|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||ml||Standard Deviation|Mean
1383121|NCT01431521|Secondary|Percent Change From Baseline Aspartate Transaminase (AST)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, including AST, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have AST data for Day 28.|||Percent change||95% Confidence Interval|Least Squares Mean
1383122|NCT01431521|Secondary|Percent Change From Baseline in Alanine Transaminase (ALT)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, specifically ALT, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have ALT data for Day 28.|||Percent change||95% Confidence Interval|Least Squares Mean
1383123|NCT01431521|Primary|Percent Change From Baseline in Hepatic Fat|Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant.|Baseline and Week 4|Per-Protocol (PP) Population consists of those participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percent change||95% Confidence Interval|Least Squares Mean
1383124|NCT01431508|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.|At Baseline and Week 12|Intention-to-Treat|||mm Hg||Standard Deviation|Mean
1383125|NCT01431391|Secondary|Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024|A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18|Month 24|The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.|||percentage of participants|||Number
1383126|NCT01431391|Primary|Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024|Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.|PA2024 ELISPOT counts at Month 24|The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.|||IFN-γ ELISPOT (per 300,000 PBMC)||Standard Error|Mean
1383127|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
1383128|NCT01431339|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
1383129|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of other therapy|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
1383130|NCT01431339|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|After 48-72 hours of therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
1383131|NCT01431300|Secondary|Quantitative Analysis Noise Ratios|"Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows:~Signal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background.~Contrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background."|14 weeks||||ratio||Standard Deviation|Mean
1383132|NCT01431300|Primary|Imaging Quality Score|"Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows:~poor / nondiagnostic~adequate~good~excellent"|14 weeks||||Units on a visualization score scale||Full Range|Mean
1383133|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 365 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383134|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 85 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383135|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 43 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383136|NCT01431287|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383137|NCT01431287|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383138|NCT01431287|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12-hr PFT set|||Litres||Standard Error|Least Squares Mean
1383139|NCT01431287|Secondary|FVC AUC(0-12h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12-hr PFT set|||Litres||Standard Error|Least Squares Mean
1383210|NCT01431014|Primary|Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery|Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose.|1 year||||ml||Standard Deviation|Mean
1383140|NCT01431287|Secondary|FEV1 AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
1383141|NCT01431287|Secondary|FEV1 AUC(0-12h) Response in Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.|||Litres||Standard Error|Least Squares Mean
1383142|NCT01431287|Secondary|Trough FVC Response on Day 365|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383143|NCT01431287|Secondary|Trough FVC Response on Day 170|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23h and at 23h 50 min after inhalation of study medication on day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383144|NCT01431287|Secondary|Trough FVC Response on Day 85|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383145|NCT01431287|Secondary|Trough FVC Response on Day 43|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383146|NCT01431287|Secondary|Trough FVC Response on Day 15|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383147|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
1383148|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
1383149|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
1383150|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
1383211|NCT01430819|Other Pre-specified|Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.~Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios."|Day 21 post-vaccination|Geometric mean of titer ratios of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1383151|NCT01431287|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383152|NCT01431287|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383153|NCT01431287|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383154|NCT01431287|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383155|NCT01431287|Secondary|Trough FEV1 Response on Day 15|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383156|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383157|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (on day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383158|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383159|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274) is the key secondary endpoint.~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383160|NCT01431287|Primary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383161|NCT01431287|Primary|Trough FEV1 Response on Day 170|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383162|NCT01431287|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.|||Litres||Standard Error|Least Squares Mean
1383212|NCT01430819|Other Pre-specified|Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40; or a pre-vaccination titer ≥ 1:10 and a four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Participants|||Number
1401987|NCT01247428|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only|8 hours||||percentage of participants||95% Confidence Interval|Number
1383163|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 365 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383164|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 85 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS|||points on a scale||Standard Error|Least Squares Mean
1383165|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 43 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383166|NCT01431274|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383167|NCT01431274|Secondary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383168|NCT01431274|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
1383213|NCT01430819|Other Pre-specified|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|GMTs of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1383169|NCT01431274|Secondary|FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
1383170|NCT01431274|Secondary|FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
1383171|NCT01431274|Secondary|FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.|||Litres||Standard Error|Least Squares Mean
1383172|NCT01431274|Secondary|Trough FVC Response on Day 365.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383173|NCT01431274|Secondary|Trough FVC Response on Day 170.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383174|NCT01431274|Secondary|Trough FVC Response on Day 85.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383175|NCT01431274|Secondary|Trough FVC Response on Day 43.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383176|NCT01431274|Secondary|Trough FVC Response on Day 15.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383177|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383178|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383179|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383214|NCT01430819|Primary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm."|Day 0 to up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population (Safety Analysis Set).|||Participants|||Number
1383180|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383181|NCT01431274|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383182|NCT01431274|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383183|NCT01431274|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383184|NCT01431274|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43.|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383185|NCT01431274|Secondary|Trough FEV1 Response on Day 15.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383186|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383187|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383188|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383189|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) is the key secondary endpoint.~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383190|NCT01431274|Primary|Saint George’s Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
1383191|NCT01431274|Primary|Trough FEV1 Response on Day 170.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
1383215|NCT01430754|Secondary|Change From Run-In in Circadian Time to Relapse During the Randomized Phase|Time to relapse is defined as a 45 minute or greater decrement in the weekly average of subjective nighttime total sleep time (nTST) compared to the Run-in Phase.|Approximately 8 weeks||||days||95% Confidence Interval|Median
1383216|NCT01430754|Secondary|Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase|Midpoint of Sleep Timing (MoST) is the measurement of the average timing of sleep relative to bedtime. The average MoST value will trend to 0 as an individual’s sleep becomes more fragmented. Improvement is defined as an increase in the average.|Approximately 12 weeks||||minutes||Standard Error|Mean
1383192|NCT01431274|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169.|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.|||Litres||Standard Error|Least Squares Mean
1383193|NCT01431170|Post-Hoc|Number of Subjects Treated Successfully at Close-Out Visit (Week 16)|Treatment Success is defined as a grade of 0 or improvement by 2 or more compared to the prior visit.|Baseline to Week 16 (Close-Out Visit)||||Number of Treatment Success|||Number
1383194|NCT01431170|Secondary|Medication Safety Outcomes|During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator.|Baseline to Week 16 (Closeout Visit )|No safety issues were reported|||Number of Adverse Events|||Number
1383195|NCT01431170|Secondary|Treatment Failure|"Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists.~Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care."|Baseline to the time of failure or Week 16 (Closeout Visit)||||Number of Treatment Failures|||Number
1383196|NCT01431170|Secondary|Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO|"Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as Treatment Success or Treatment Failure according to study protocol."|Baseline to Week 16 (Closeout Visit)||||participants|||Number
1383197|NCT01431170|Secondary|Number of Recurrences by Randomization Group|"Recurrence is defined as when the NLDO with infection in the subject’s study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit.~Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group."|Baseline to Week 16 (Closeout Visit )|The overall study recurrence rate was 10% study-wide (2 of 20 subjects), with one Besivance subject (11%), and one Polytrim subject (9%) experiencing recurrence.|||Recurrence Subjects|||Number
1383198|NCT01431170|Primary|Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier.|"The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4:~0: No tearing and discharge.~1: Tearing, moderate mucous discharge around nasolacrimal punctum~2: Moderate redness of the medial eyelid with mucous discharge~3: Redness and swelling of the eyelid with mucopurulent discharge~4: Redness and swelling of eyelid with purulent discharge~Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following:~Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit.~Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit.~Treatment Failure: grade is worse than or same as the baseline visit."|Baseline to Week 8||||participants|||Number
1383199|NCT01431144|Primary|Soft Tissue Thickness Over the Implant|Soft tissue thickness at the facial osseous crest.|1 year||||mm||Standard Deviation|Mean
1383200|NCT01431131|Secondary|Histologic Healing of the Osseous Graft|Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages|4 months||||percentage vital bone||Standard Deviation|Mean
1383201|NCT01431131|Primary|Horizontal Ridge Dimension|WIll be measured with a digital caliper at baseline and 4 months.|Baseline and 4 months||||mm||Standard Deviation|Mean
1383202|NCT01431079|Secondary|Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine|"Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.~The difference between post and pre-test was taken to determine a change score. This score was then used for regressions."|Post interventions and up to 3 months follow-up|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
1383217|NCT01430754|Secondary|Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase|UQ-dTSD measures the average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) from run-in and randomized phase. Lower number indicates improvement.|Approximately 12 weeks||||minutes||Standard Error|Mean
1383203|NCT01431079|Secondary|Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine|"Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability.~Difference between post and pre-test were used to obtain a change score. This score was used for regressions."|Post interventions and up to three months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
1383204|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine|"Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.~A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression."|post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
1383205|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine|"Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
1383206|NCT01431079|Secondary|Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
1383207|NCT01431079|Secondary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
1383208|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units)|"Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted.~Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale."|Post intervention and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
1383209|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine|Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted.|Post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||participants|||Number
1383219|NCT01430754|Secondary|Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks||||participants|||Number
1383220|NCT01430754|Primary|Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks||||participants|||Number
1383221|NCT01430741|Post-Hoc|Estimated Proportion of Veterans Without Negative Housing Exits|We obtained information on negative housing exits from the HUD-VASH Exit form, which is available in HOMES and tracks the dates and reasons for all exits from the program. We measured whether and when a Veteran experienced a negative housing over the period from study enrollment (i.e. the first date of MISSION-Vet for those served by case managers in the GTO group and the date of the first MISSION-Vet session provided to any Veteran at the appropriate study site for this in the comparison group) until the end of the study observation period; the maximum follow-up time was 2.4 years, but only for HUD-VASH Exits. A negative exit was defined as an exit from HUD-VASH that occurred due to non-compliance with case management, eviction, Veteran dissatisfaction with housing, inability to locate Veteran and incarceration. Kaplan-Meier survival curves to calculate an estimate of the proportion of Veterans in each arm/group not experiencing a negative exit from housing at the study’s endpoint.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Proportion of Veterans||95% Confidence Interval|Number
1383222|NCT01430741|Post-Hoc|Predicted Values of Veteran Emergency Department Visits for Medical and Mental Health Concerns|Number of emergency department visits for medical and for mental health. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an emergency department visit for medical or mental health conditions , and not a count of number of emergency department visits. We used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study’s end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Log Odd Units of Emergency Dept. Visits||Standard Error|Least Squares Mean
1383223|NCT01430741|Post-Hoc|Predicted Values of Veteran Inpatient Hospitalizations for Medical and Mental Health Conditions|Number of inpatient hospitalization for medical and mental health conditions. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an inpatient hospitalization for medical or mental health conditions , and not a count of number of hospitalizations. Specifically, we used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study’s end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Inpatient Hospitalization Log Odds Units||Standard Error|Least Squares Mean
1383224|NCT01430741|Post-Hoc|Drug and Alcohol Dependence|Examined monthly alcohol and drug use by Veterans. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Monthly Substance Use||Standard Error|Least Squares Mean
1383225|NCT01430741|Post-Hoc|Number of Services Provided by Case Managers and Peers to Veterans|Services provided by Case Managers OR Peers was computed by a count of the number of contacts between case managers OR peers and Veterans. This computed a total of all Veteran contacts, which was the sum of face-to-face contacts with Veterans and contacts on behalf of Veterans (described as Veteran contacts) with other stakeholders (e.g. family, medical providers). Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. We used a linear-mixed effects model to calculate a Least-Squares Mean for each group at the study’s end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Number of Service Contacts||Standard Error|Least Squares Mean
1383226|NCT01430741|Primary|MISSION Fidelity Index|The fidelity index assesses the presence or absences of activities within MISSION-Vet – DRT, peer led sessions, self-guided exercises, referrals made, and/or delivery of the workbook, to each participating Veteran. We analyzed fidelity as the percent of adoption of MISSION-Vet. The threshold for fidelity to adopt MISSION-Vet is 1 contact between the case manager and each participating Veteran. There is no composite score, fidelity to MISSION-Vet is if the case manager conducted at least 1 session with a Veteran.This measure was embedded into the VA Electronic Medical Record System. The investigators will assess the impact GTO has in facilitating adoption and use with fidelity to the MISSION-Vet 12-month service delivery platform, in comparison to implementation as usual.|12-months|Clinician fidelity to MISSION-Vet using IU or GTO. Only assessed Staff population.|||percentage of MISSION-Vet staff use|||Number
1383235|NCT01430611|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature >39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set (SafAS). A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (where classification was per vaccine randomized to) and also Group 1 SafAS (where classification was according to vaccine actually received).|||Participants|||Number
1383236|NCT01430611|Secondary|Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1383237|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1383238|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1383239|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1383240|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1383241|NCT01430611|Primary|Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 30 post-vaccination|Seroconversion was assessed in the Per-protocol Analysis Set.|||Participants|||Number
1383242|NCT01430585|Secondary|Number of Participants With Genetic Alterations: Phase 2|Following genetic alterations were planned to be analyzed: mutations in Phosphoinositide 3-kinase, catalytic, alpha (PIK3CA), amplification of PIK3CA, Phosphate and tensin homolog (PTEN) deficiency, and changes in other genes or proteins in, or impacting V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS), Insulin-like Growth Factor 1 Receptor (IGF-1R), phosphatidylinositol 3-kinase (PI3K)/ mammalian target of rapamycin (mTOR) pathway.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383243|NCT01430585|Secondary|Change From Baseline in Pharmacodynamic, Cell Proliferation and Survival Biomarkers in Biopsied Tumor Tissue at Week 2 and 6: Phase 2|Change from baseline in following pharmacodynamic parameters were planned to be calculated: expression and/or phosphorylation of Phosphoinositide-3-kinase (PI3K) pathway proteins in biopsied tumor tissue and markers of cell cycle and survival.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383244|NCT01430585|Secondary|Pharmacokinetic (PK) Parameters of PF-04691502 and Letrozole: Phase 1B and 2|Phase 1B: Following PK parameters were planned to be calculated from the plasma concentration time data using standard non-compartmental methods. For PF-04691502: area under the curve from time zero to last quantifiable concentration (AUClast), area under the curve from time zero to end of dosing interval (AUCtau), maximum observed plasma concentration (Cmax), minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), time to reach maximum observed plasma concentration (Tmax), observed accumulation ratio (Rac [obs]); for letrozole: AUClast, Cmax. Phase 2: Following PK parameters were planned to be calculated for PF-04691502 from the plasma concentration time data using standard non-compartmental methods- AUClast, Cmax and Tmax.|Phase 1B: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1 (letrozole alone), Day 2 (PF-0491502 alone), Day 12, Week 5 (PF-0491502 and letrozole in combination); Phase 2: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1, pre-dose on Week 2, 6|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383257|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-5: Omalizumab vs. Placebo|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent–to-treat|||percent adherence||Standard Error|Mean
1383245|NCT01430585|Secondary|Number of Participants With Objective Response (OR): Phase 1B and 2|Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No appearance of new lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (>=) 30 percent (%) decrease from baseline of the sum of diameters of all target lesions, using the short diameter in the sum for target nodes and the longest diameter in the sum for all other target lesions.|Phase 1B: Baseline, Week 12, end of treatment (Week 34); Phase 2: Baseline, Week 6, 16 or ET|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383246|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Corrected QT (QTc) Interval: Phase 1B||Phase 1B: Baseline up to end of treatment (Week 34)|Data was not analyzed due to premature termination of the study.||||||
1383247|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs: Phase 1B and 2|Vital signs assessments planned to include measurement of blood pressure and heart rate.|Phase 1B: Baseline up to 28 days after last dose of study treatment (Week 34); Phase 2: Baseline up to Week 16 or ET|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383248|NCT01430585|Secondary|Number of Participants With Clinically Significant Laboratory Tests Abnormalities: Phase 1B and 2|Laboratory analysis planned to include blood chemistry, hematology and urinalysis.|Phase 1B: Baseline up to end of treatment (Week 34); Phase 2: Baseline up to Week 16 or early termination (ET)|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383249|NCT01430585|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 2|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 2: Baseline up to 28 days after last administration of study treatment|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383250|NCT01430585|Primary|Change From Baseline in Ki-67 Percent Positive Tumor Cells in Biopsied Tumor Tissue at Week 6: Phase 2|Nuclear proliferation marker Ki-67 was to be assessed by immunohistochemistry technique in all specimens.|Phase 2: Baseline, Week 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
1383251|NCT01430585|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 1B|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 1B: Baseline up to 28 days after last administration of study treatment|Safety analysis set included all enrolled participants who started study treatment.|||participants|||Number
1383252|NCT01430468|Secondary|Intra-operative Photographs|We will use the intra-operative photographs to qualitatively document the surgical steps. These photos may be useful to explain a deviation in the surgery than what would have been expected by the pre-operative simulator.|Post Op CT within 1 year from surgery|||||||
1383253|NCT01430468|Primary|Comparing Glenoid Component Positioning to Pre Operative Planning|Final implant position will be determined by comparing the position of the glenoid component on the post-operative CT scans with the implant position planned pre-operatively on the surgical simulator. These measurements will be in millimeters and degrees.|1 month post op||||Degrees||Standard Deviation|Mean
1383254|NCT01430455|Primary|29 Item Hamilton Rating Scale for Depression (HamD29)|29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.|Hamilton 29 score at baseline (start date of medication) and week 16|2 patients who did not make it to week 16 (one dropped out at week 3 and one dropped out at week 9)|||Hamilton Depression score||Standard Error|Mean
1383255|NCT01430403|Secondary|Comparison of Home Allergen (Cockroach) Exposure and Asthma Exacerbations: Omalizumab Versus Placebo|Residential environmental exposure to cockroach allergen of participants in the context of the risk of asthma exacerbations and effect of omalizumab versus placebo (control) on asthma exacerbations was explored. Presence of cockroach allergen in household dust samples was assessed. Exacerbation defined as: participant required either 1.)a prescribed course of systemic steroids by a clinician2.)initiation of a course of systemic steroids or 3.)a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. In cases that a participant initiated and completed a course of systemic steroids without clinician involvement, the course was counted as an exacerbation only with fulfillment of the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day).|90 Day outcome period|"Prespecified Outcome Measure: analysis limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data)."|||Participants|||Count of Participants
1383256|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-4: Omalizumab vs. ICS|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent-to-treat|||percent adherence||Standard Error|Mean
1383260|NCT01430403|Secondary|Work Disruptions Due to Child’s Asthma, Treatment Steps 2-4: Omalizumab vs. ICS|The ratio of the work hours missed due to child’s asthma over the numbers of work hours in the past 14 days among caretakers working|90 Day outcome period|Intent-to-treat with available data|||Ratio||Standard Error|Mean
1383261|NCT01430403|Secondary|Work Disruptions Due to Child’s Asthma, Treatment Steps 2-5: Omalizumab vs. Placebo|The ratio of the work hours missed due to child’s asthma over the numbers of work hours in the past 14 days among caretakers working.|90 Day outcome period|Intent–to-treat with available data|||Ratio||Standard Error|Mean
1383262|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-4: Omalizumab vs. ICS|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined.|90 Day outcome period|Intent-to-treat with available C-ACT Scores|||C-ACT Score||Standard Error|Mean
1383263|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-5: Omalizumab vs. Placebo|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined|90 Day outcome period|Intent–to-treat with available C-ACT Scores|||C-ACT Score||Standard Error|Mean
1383264|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-4: Omalizumab vs. ICS|The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients ≥12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of ≤19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent-to-treat with available ACT Scores|||ACT Score||Standard Error|Mean
1383265|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-5: Omalizumab vs. Placebo|Outcome measure description: The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients ≥12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of ≤19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent–to-treat with available ACT scores|||ACT Score||Standard Error|Mean
1383266|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-4: Omalizumab vs. ICS|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.|90 Day outcome period|Intent-to-treat|||percent FEV1/FVC ratio||Standard Error|Mean
1383267|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5: Omalizumab vs. Placebo|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 – 19 years of age=85%.|90 Day outcome period|Intent–to-treat|||percent FEV1/FVC ratio||Standard Error|Mean
1383268|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4: Omalizumab vs. ICS|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent-to-treat|||percent predicted FEV1||Standard Error|Mean
1383269|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5:Omalizumab vs. Placebo|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent–to-treat|||percent predicted FEV1||Standard Error|Mean
1383270|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-4: Omalizumab vs. ICS|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent-to-treat with available CASI scores|||CASI Score||Standard Error|Mean
1383271|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-5: Omalizumab vs. Placebo|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent–to-treat|||CASI Score||Standard Error|Mean
1383310|NCT01430091|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.|||nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1383272|NCT01430403|Secondary|Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo|Asthma exacerbation is defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the intent of this measure was to assess the comparator group of placebo against omalizumab.|90 Day outcome period|"The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data)."|||Total Number of Viral Infections||Standard Error|Mean
1383273|NCT01430403|Secondary|Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo|Severity asthma symptoms is defined as the highest value among the following 3 variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which a participant had to slow down or discontinue play/physical activities over a two week period associated with a viral infection. This outcome looks at the effect by group on number of days with asthma symptoms and infections. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the the intent of this measure was to assess the comparator group of placebo against omalizumab|90 Day outcome period|"The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data)."|||Maximum Symptoms Days||Standard Error|Mean
1383274|NCT01430403|Secondary|Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples|Asthma exacerbation:defined by a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the 1st day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥ 10mg per day for ≥1 day. Exacerbations were then associated with viral respiratory infections based on nasal mucus samples collected monthly. Nasal mucus samples were categorized as having exacerbations or not having exacerbations. Participants could potentially be counted in each group, as participants could have samples with exacerbations and samples without exacerbations.|90 Day outcome period|Nasal mucus samples|||Percent Samples with virus|Number of Samples Analyzed||Number
1383275|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4)|Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Inhaled corticosteroid boost therapy (ICS) and Omalizumab arms at Treatment Steps 2-4.|90 Day outcome period|Intent-to-treat|||Percent of adjusted prevalence|||Number
1383276|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5])|Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Placebo and Omalizumab arms across all treatment steps (Steps 2-5).|90 Day outcome period|Intent–to-treat|||Percent of adjusted prevalence|||Number
1383277|NCT01430325|Primary|Participant Perception of Breathing Gas|Percent of participants in each arm guessing that their breathing gas was 100% oxygen.|Within 15 minutes of chamber excursion|40 of 42 participants provided an answer to this question.|||percentage of participants|||Number
1383278|NCT01430325|Primary|Participant Perception of Depth|Mean depth perception for participants providing a free response.|Within 15 minutes of chamber excursion|"23 of 42 participants provided a numerical response. The remainder selected I do not know."|||fsw||Standard Deviation|Mean
1383279|NCT01430325|Primary|"Participants Indicating I do Not Know on Depth Questionnaire."|"Participants indicating I do not know on depth questionnaire instead of providing a free response guess."|Within 15 minutes of chamber excursion|All participants who enrolled in the study were analyzed.|||participants|||Number
1383280|NCT01430299|Primary|Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery|Posterolateral fusion by radiographic assessment 12 months post surgery|12 months|One to 3 spinal levels between L3 and S1 were treated per patient. Fusion was assessed twice per treated level. There were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels but 46 OsteoSurge assessments and 74 rhBMP-2 assessments.|||radiographic assessments|radiographic assessments||Count of Units
1383281|NCT01430182|Primary|Opioid Consumption|Number of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit|First 24 hours after discharge from Post-Anesthesia Care Unit||||mg of morphine IV equivalents||Standard Deviation|Mean
1383282|NCT01430169|Primary|AUX-II Tmax After Injection 2|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19) In addition, 2 subjects have been excluded from the analysis due to ELISA interference. Of the 38 AUX-II profiles,23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.|||hours||Standard Deviation|Mean
1383283|NCT01430169|Primary|AUX-I Tmax After Injection 2|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|"Pharmacokinetic (PK) population (N=19). In addition, 2 subjects have been excluded from the analysis due to ELISA interference.~Of the 38 AUX-I profiles, 7 had no quantifiable plasma concentrations through 24 hours post injection."|||hour||Standard Deviation|Mean
1383284|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)|||ng*h/mL||Standard Deviation|Mean
1383285|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng*h/mL||Standard Deviation|Mean
1383286|NCT01430169|Primary|AUX-II Cmax After Injection 2|Maximum AUX-II enzyme concentration from zero to 24 hours after Injection 2. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)|||ng/mL||Standard Deviation|Mean
1383287|NCT01430169|Primary|AUX-I Cmax After Injection 2|Maximum AUX-I enzyme concentration from zero to 24 hours after Injection 2.AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng/mL||Standard Deviation|Mean
1383288|NCT01430169|Primary|AUX-II Tmax After Injection 1|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19) One subject was excluded from AUX-II PK analyses due to insufficient quantities of plasma for bioanalysis. Of the 38 AUX-II profiles, 23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.|||hours||Standard Deviation|Mean
1383289|NCT01430169|Primary|AUX-I Tmax After Injection 1|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). For 3 subjects Tmax was considered missing if concentration was BLQ for all time points at that injection and 2 subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||hours||Standard Deviation|Mean
1383290|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19)|||ng*h/mL||Standard Deviation|Mean
1383291|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng*h/mL||Standard Deviation|Mean
1383292|NCT01430169|Primary|AUX-II Cmax After Injection 1|Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19).|||ng/mL||Standard Deviation|Mean
1383293|NCT01430169|Primary|AUX-I Cmax After Injection 1|Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng/mL||Standard Deviation|Mean
1383294|NCT01430130|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months|||||||
1383295|NCT01430130|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks|||||||
1383296|NCT01430130|Secondary|Ease of Use||Up to 12 months|||||||
1383298|NCT01430130|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.~[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O’Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|6 months|Per protocol, all eligible patients who did not exit the study prematurely.|||Units on a scale||Standard Error|Mean
1383299|NCT01430104|Secondary|Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
1383300|NCT01430104|Secondary|Concentrations of Serum 25-Hydroxy-Vitamin D||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1383301|NCT01430104|Secondary|Change From Baseline in Daily Urine Calcium Excreted||Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis.|||grams per day (g/day)||Standard Deviation|Mean
1383302|NCT01430104|Secondary|Mean Daily Urine Calcium Excreted||Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.|||grams per day (g/day)||Standard Deviation|Mean
1383303|NCT01430104|Secondary|Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline|Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.|||participants|||Number
1383304|NCT01430104|Secondary|Change From Baseline in Serum Calcium|Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were controlled for Day, Timepoint, Day*Timepoint, and random error. Postdose refers to after Teriparatide dose.|Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.|||mg/dL||90% Confidence Interval|Least Squares Mean
1383305|NCT01430104|Secondary|Mean Serum Calcium Levels|Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).|Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.|||mg/dL||90% Confidence Interval|Least Squares Mean
1383306|NCT01430104|Secondary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis.|||participants|||Number
1383307|NCT01430104|Primary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 – serum albumin concentration (grams per deciliter [g/dL]). Postdose refers to after Teriparatide dose.|Day 28 (16 and 24 hours postdose)|All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.|||participants|||Number
1383308|NCT01430091|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.|||hours||Full Range|Median
1383309|NCT01430091|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel’s Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1383323|NCT01429532|Primary|Surgically Induced Astigmatism|Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation.|post-operative week 1, post-operative month 1, and post-operative month 3||||Diopters||Standard Deviation|Mean
1383311|NCT01429987|Secondary|Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score|The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||scores on a scale||Standard Error|Least Squares Mean
1383312|NCT01429987|Secondary|Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period|"The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)"|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||scores on a scale||Standard Error|Least Squares Mean
1383313|NCT01429987|Secondary|Change From Baseline in 12-week SBM Weekly Frequency Rate|The number of Spontaneous Bowl Movements experienced per week.|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||SBMs per week||Standard Error|Least Squares Mean
1383314|NCT01429987|Secondary|Change From Baseline in 12-week CSBM Weekly Frequency Rate|The number of Complete Spontaneous Bowel Movements (CSBMs) per week|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||CSBMs per week||Standard Error|Least Squares Mean
1383315|NCT01429987|Primary|Overall Responder 9/12 Weeks|A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||% of Overall Responder 9/12 weeks|||Number
1383316|NCT01429623|Secondary|Change in Disability Assessment in Dementia for Ladostigil Versus Placebo Population|Mean value change (from baseline) in Disability Assessment in Dementia (DAD) across entire study period. DAD evaluates the basic and instrumental activities in daily activities of elderly people with dementia. Higher scores reflect better functioning. DAD ranges from 0 to 100.|3,6,12,18,24,30 and 36 months||||Change from basline on units on a scale||Standard Deviation|Mean
1383317|NCT01429623|Secondary|Change in Neuropsychiatric Test Battery for Ladostigil Versus Placebo Population|Mean value change (from baseline) in Neuropsychiatric Test Battery (NTB) across entire study period. The NTB included the following well known cognitive tests: Rey Auditory Verbal Learning Test (RAVLT), Controlled Word Association Test (COWAT), Category Fluency Test (CFT), WMS-R Digit Span, and Trail Making Part A and B. The mean value was comprised of the z score of each of these tests with all z scores in the direction of higher scores better functioning. Range -3 to +3.|3,6,12,18,24,30 and 36 months|Modified Intent to treat (all randomized subject with at least one post baseline assessment)|||Change from basline on units on a scale||Standard Deviation|Mean
1383318|NCT01429623|Secondary|Change in Geriatric Depression Scale for Ladostigil Versus Placebo Population|"Mean value change (from baseline) in Geriatric Depression Scale (GDS) across entire study period. The GDS ranges from 0 to 30. Scores of 0-9 are considered normal, 10-19 mildly depressed, and 20-30 severely depressed."|3,6,12,18,24,30 and 36 months|Modified Intent to Treat|||Change from basline on units on a scale||Standard Deviation|Mean
1383319|NCT01429623|Primary|Conversion From Mild Cognitive Impairment to Alzheimer's Disease Compared to Placebo|"Total number of conversions from Mild Cognitive Impairment to Alzheimer's disease across entire 3 year study period. Conversion is determined, or defined, by a Clinical Dementia Rating (CDR) score of greater than or equal to one.~Composite rating ranges from 0 no symptoms of dementia to 3 Severe symptoms of dementia."|3,6,12,18,24,30 and 36 months|All randomized subjects with at least one post-baseline visit.|||Participants|||Count of Participants
1383320|NCT01429584|Secondary|Satisfaction With Pain Control|A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control.|Within 30 days|Same as other outcome measures|||Likert Satisfaction Scale||Standard Deviation|Mean
1383321|NCT01429584|Secondary|Pain Relief|Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Same as other outcome measures.|||Visual Analogue Scale for pain||Standard Deviation|Mean
1383322|NCT01429584|Primary|Abnormal Lung Function|Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Power analysis was performed and a drop-out rate of 10% was anticipated.|||participants w/ abnormal diaphragm fxn|||Number
1383324|NCT01429532|Secondary|Best-corrected Visual Acuity|The best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist, preoperatively and at postoperative 1 day, 1 week, 1 month and 3 months.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis.|||logMAR||Standard Deviation|Mean
1383325|NCT01429532|Primary|Central Cornea Endothelial Cell Loss|Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis and sample size calculation. Mean ultrasound time (UST), surgical time, cumulative dissipated energy (CDE), total BSS volume, and SIA were compared using multifactor analysis of variance.|||% of endothelial cell loss||Standard Deviation|Mean
1383326|NCT01429441|Secondary|Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24|≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.|Month 24|FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis.|||Percentage (weighted across strata)||95% Confidence Interval|Number
1383327|NCT01429441|Primary|Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28|Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.|Day 28|Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits.|||Percentage (weighted across strata)||95% Confidence Interval|Number
1383328|NCT01429298|Post-Hoc|Number of Participants Who Reported no Pain or Mild Pain at 30 Minutes||30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
1383329|NCT01429298|Post-Hoc|Number of Patients Who Achieved Absolute Pain Intensity Score of 3 or Less at 30 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)"|30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
1383330|NCT01429298|Post-Hoc|Number of Participants Who Achieved at Least 50% Decline in NRS Pain Score at 30 Minutes||30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
1383331|NCT01429298|Primary|Mean Change in Pain Intensity Score From Baseline to 30 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The change in NRS score is calculated by subtracting the score at 30 minutes post treatment from the score at baseline, before treatment. The average of these values was calculated."|30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||units on a scale||Standard Deviation|Mean
1383332|NCT01429298|Primary|Number of Participants Who Declined Additional Medication at 30 Minutes|Amount of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, “Do you want more pain medication?”|30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
1383333|NCT01429285|Post-Hoc|Pain Intensity Score at 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||units on a scale||Inter-Quartile Range|Median
1383334|NCT01429285|Post-Hoc|Number of Patients With a Pain Intensity Score of 3 or Less at 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
1383335|NCT01429285|Post-Hoc|Number of Patients With 50% or Greater Decline in Pain Intensity Score From Baseline to 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The 50% or greater change in pain score is measured by subtracting the pain score at 60 minutes from the pain score at baseline, then dividing that value by the original baseline value and multiplying by 100% to get a percent change value."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
1383336|NCT01429285|Post-Hoc|Number of Patients Who Achieved Satisfactory Analgesia at 60 Minutes Post-baseline|"Satisfactory analgesia is defined as the patient declining additional pain medication when asked the question, Do you want more pain medication?. This measure refers only to the answer to this question asked at the 60 minute mark. The Primary Outcome (1. Primary Outcome - Number of Patients with successful treatment) refers to the answering no to this question at 15 minutes or 60 minutes post-baseline."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
1383337|NCT01429285|Post-Hoc|Number of Patients Who Achieved Satisfactory Analgesia at 15 Minutes Post-baseline|"Satisfactory Analgesia is defined as declining additional pain medication when asked the question, Do you want more pain medication?"|15 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
1383338|NCT01429285|Secondary|Mean Change in Pain Intensity From Baseline to 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The change in scores over time is calculated by subtracting the score at 60 minutes from the score at baseline (before treatment). These change values were then averaged."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||units on a scale||Standard Deviation|Mean
1383339|NCT01429285|Primary|Number of Patients With Successful Treatment|"Number of patients with successful treatment is defined as the number of patients who declined additional pain medication within 1 hour of study entry when asked the question, Do you want more pain medication?. This measure looks at declining pain medication at either 15 minutes or 60 minutes, whereas 4. Post-Hoc refers only to the answer to the question at the 60 minute mark post-baseline."|1 hour|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
1383340|NCT01429272|Secondary|Remission Rate|Remission defined as a score of <11 on Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.|Six weeks|Note numbers do not match the participants flow because participants who did not return for at least one post treatment visit could not be included in the analysis.|||percentage of participants|||Number
1383341|NCT01429272|Primary|Treatment Response|Response to treatment defined as a >50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.|Six weeks|Note numbers do not match the participants flow because participants who did not return for at least one post treatment visit could not be included in the analysis.|||Percentage of Participants|||Number
1383342|NCT01429259|Secondary|Meropenem Pharmacodynamics|Meropenem exposures defined from the population model for each participant will be analyzed as a function of the isolated pathogens meropenem minimum inhibitory concentration (MIC) to define the exposure of meropenem associated with an absolute and relative percent change in the Forced Expiratory Volume (FEV1).|14-21 days|||||||
1383343|NCT01429259|Secondary|Practicality of 3 Hour Prolonged Infusion|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be utilized to assess patient or parent assessments of the burden of the prolonged infusion treatment. The CFQ-R will be administered at the beginning of the study and then within 7 days after completion of meropenem therapy.|14-21 days|||||||
1383344|NCT01429259|Secondary|Safety|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. Participants will be monitored for any sign of symptom of adverse events throughout the course of the study. An adverse event will be defined as any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug.|14-21 days|||||||
1383345|NCT01429259|Primary|Population Pharmacokinetics - Volume of Central Compartment|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment.|During 8 hour dosing interval after 3rd meropenem dose||||L/kg||Standard Deviation|Mean
1383346|NCT01429259|Primary|Population Pharmacokinetics - Total Body Clearance|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.|8 hour dosing interval after 3rd meropenem dose||||L/hr/kg||Standard Deviation|Mean
1383347|NCT01429077|Secondary|Participation in Everyday Activities (Maintenance)||Change in participation in everyday activities from 6 weeks to 12 weeks|||||||
1383348|NCT01429077|Secondary|Functional Communication Skills (Maintenance)||Change in functional communication skills from 6 weeks to 12 weeks|||||||
1383349|NCT01429077|Secondary|Western Aphasia Battery Reading and Writing Scores (Maintenance)||Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks|||||||
1383350|NCT01429077|Secondary|Western Aphasia Battery Aphasia Quotient (Maintenance)||Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks|||||||
1383351|NCT01429077|Secondary|Western Aphasia Battery - Reading and Writing Scores||Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks|||||||
1383352|NCT01429077|Secondary|Participation in Everyday Activities|Measures on CETI, QCL,BOSS, CCRSA.|Change from Baseline in participation in everyday activities at 6 weeks|||||||
1383353|NCT01429077|Secondary|Functional Communication Skills|Scores derived from language sample analyses|Change from Baseline in functional communication skills at 6 weeks|||||||
1383354|NCT01429077|Primary|Language Quotient (LQ) on the Western Aphasia Battery|"Includes a measure of auditory comprehension, oral expression, reading and written expression skills.~The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement."|Change from Baseline in Western Aphasia Battery LQ at 6 weeks||||units on a scale||Standard Deviation|Mean
1383355|NCT01429064|Primary|Number of Participants With Adverse Events|Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.|From first dose of study treatment up to 4 weeks after last dose of study treatment|Safety population|||participants|||Number
1383399|NCT01428336|Primary|Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs|Correlation of total cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table|1 hour for the CST interventions and 2 hour for the ITT interventions|Correlation of total cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.|||correlation coefficient||95% Confidence Interval|Number
1383356|NCT01429051|Secondary|Number of Participants With Adverse Events (AEs)|The severity (intensity of each AE was assessed as mild (transient symptoms, no interference with daily activities), moderate (marked symptoms, moderate interference with daily activities), or severe (considerable interference with daily activities) by the investigator. Serious adverse events are defined as any untoward medical occurrence that at any dose results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The investigator assessed each AE as either related or not related to study treatment.|12 weeks|Safety analysis set|||participants|||Number
1383357|NCT01429051|Secondary|Efficacy Phase: General Impression (GI) Score at 60 Minutes After First Dose|"Participants assessed their general impression (GI) of treatment efficacy for treated BTP episodes at 60 minutes after first dose of study drug. The validated, categorical 5-point Verbal Rating Scale (VRS) was used for this assessment and scored as follows:~0 =poor;~1 =fair;~2 =good;~3 =very good;~4 =excellent."|During the efficacy phase (II), at each episode of breakthrough pain, 60 minutes after first dose of study drug.|Efficacy Phase, Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
1383358|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 33% or 50% Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • Greater than 33% reduction in PI from time 0; • Greater than or equal to 50% reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set|||proportion of breakthrough pain episodes|Participants||Number
1383359|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 1, 2 or 3 Point Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • greater than or equal to 1 point reduction in pain intensity (PI) from time 0, • greater than or equal to 2 point reduction in PI from time 0, and • greater than or equal to 3 point reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set|||proportion of breakthrough pain episodes|Participants||Number
1383360|NCT01429051|Secondary|Efficacy Phase: Sum of Pain Intensity Differences (SPID0-60 and SPID0-30) Derived From PI Scores|"The SPID30 and SPID60 represent the average improvement in pain intensity over the 30 minute interval and 60 minute interval, respectively. SPIDt was calculated as the area under the curve (AUC) for Pain Intensity Difference over the time interval 0 to t minutes, respectively, divided by the length of the time interval (t minutes). A positive value is a decrease (improvement) of the pain.~Pain intensity was assessed at 0, 5, 30 and 60 minutes after study drug using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
1383361|NCT01429051|Secondary|Efficacy Phase: Pain Intensity Difference (PID) at 5, 30, and 60 Minutes After First Dose of Study Drug|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0, 5, 30 and 60 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug.|Efficacy Phase, Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
1383362|NCT01429051|Secondary|Incidence of Improvement or Worsening in Nasal Mucosa Sign or Abnormality Score|Medical examination of the nasal cavity by rhinoscopy was performed by an oto-rhino-laryngologist before the start of study treatment and at 12 weeks. Signs and any abnormalities were observed for each nostril using the following 4 points assessment scale: • 0 =not present; • 1 =present in a mild degree; • 2 =present in a moderate degree; • 3 =present in a severe degree. A difference in score of 1 or more from Baseline to the end of treatment represented a worsening, while a negative value indicated an improvement of the observed clinical sign. The oto-rhino-laryngologist also assessed whether worsening of a sign was related to study drug. Assessments for both left and right nostrils are presented together. The incidence is calculated as the number of assessments (n) in the improvement or worsening category divided by the number of assessments with a non-missing score for the Nasal Mucosa or Abnormality assessment. Only those signs or abnormalities with n>0 were included|Baseline and at 12 weeks|Safety Analysis Set, which included all patients who received at least 1 dose of INFS (including the initial test dose) with non-missing assessments.|||proportion of nostril assessments|Participants|95% Confidence Interval|Number
1383363|NCT01429051|Primary|Induction Phase: Pain Intensity Difference at 10 Minutes (PID10) After Treatment|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 10 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II), at each episode of breakthrough pain, at 0 and 10 minutes after first dose of study drug.|The Full Analysis Set consisted of all randomly assigned participants who entered the Efficacy Phase (II) of the trial and were treated for at least 1 BTP episode with double-blind INFS in the Efficacy Phase of the trial.|||units on a scale||95% Confidence Interval|Least Squares Mean
1384977|NCT01409837|Primary|Total Sperm Cell Count Per Milliliter of Seminal Fluid.|the number of sperm cells counted per milliliter volume of seminal fluid|Week 96|All the patients randomized into each group were analyzed on the basis of intention-to-treat|||Millions/ml||Standard Deviation|Mean
1383364|NCT01428882|Secondary|Rate of Patients and Physician Satisfaction With Sedation|"Endoscopists and patients rated their satisfaction with sedation in a 10-cm visual analogue scale after discharge.The patients were contacted 24–48 h after the procedure to answer a questionnaire regarding if they remembered scope insertion or scope removal and willingness to repeat it with a similar protocol and rated their satisfaction and pain perception from 0 to 10. This phone survey was done by the nurse specifically making the measurements in the endoscopy room, who was blinded to the sedation regimen.~For the interpretation of results of the 0-10 point numerical scale, 0 stands for 'extremely dissatisfied with sedation level during the endoscopic procedure', whereas 10 stands for 'extremely satisfied with sedation level during the endoscopic procedure."|Up to 1 hour after colonoscopy for endoscopists and up to 48 hours for patients||||units on a scale||Full Range|Mean
1383365|NCT01428882|Secondary|Rate of Sedation-related Complications During the Procedure and the Recovery Phases|The following events were considered complications of procedural sedation: a decline in oxygen saturation to less than 85 % longer than 30 s after increasing the oxygen flow rate to 5 L/min and transient propofol interruption, a heart rate less than 40 beats per minute and blood pressure less than 80/50 mmHg. Major complications were defined as need for mechanical ventilation or any cardiorespiratory event requiring anaesthesiologist assistance.|Up to two hours, including colonoscopy performance and recovery period||||participants|||Number
1383366|NCT01428882|Secondary|Duration of Recovery After the Endoscopic Procedure|"After completion of the procedure, the patient stood in the examination room monitored continuously by a nurse. When patients responded to normal verbal command, they were asked to sit up and were offered a drink. This was considered the early recovery time.~If they were able to stand unassisted by the bed and had stable hemodynamics parameters (saturation>90 % on room air and blood pressure and heart rate within 20 % of baseline), they were transferred to a locker room accompanied by a relative. The discharge criteria included ability to stand unassisted and tolerate clear liquids once dressed. Once a patient met discharge criteria, they were allowed to leave at their own discretion"|Up to 1 hour after colonoscopy||||minutes||Full Range|Mean
1383367|NCT01428882|Primary|Level of Sedation Throughout the Entire Procedure|Assessment every two minutes of the level of sedation during the endoscopic procedure, rating it as minimal, moderate or deep.|Up to 1 hour after introduction of the colonoscope||||participants|||Number
1383368|NCT01428765|Primary|Concomitant Medication||Baseline||||participants|||Number
1383369|NCT01428765|Primary|Medical History||Baseline||||participants|||Number
1383370|NCT01428765|Primary|Age Group||Baseline||||participants|||Number
1383371|NCT01428765|Primary|Gender||Baseline||||participants|||Number
1383372|NCT01428765|Primary|Antithrombotic Treatment Choice at Baseline||Baseline||||participants|||Number
1383373|NCT01428765|Primary|HAS-BLED Risk Score|The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.|Baseline||||participants|||Number
1383374|NCT01428765|Primary|CHA2DS2-VASc Score|The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65–74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to “low risk”, a score of 1 corresponds to “intermediate risk”, and a score of 2 or more corresponds to “high risk”.|Baseline||||participants|||Number
1383375|NCT01428765|Primary|CHADS2 Score|CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).|Baseline||||participants|||Number
1383376|NCT01428713|Primary|To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.|"To assess~change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of TA~change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of TA~change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of COCP~change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of COCP~PBAC score:~Quantitative score to measure menstrual blood loss. Scale range: Minimum - 0 score, Maximum: No maximum Interpretation: Score > 100 indicates heavy menstrual bleeding~Peds QL score:~Score to measure quality of life in children Scale range: Minimum: 0, Maximum 100 Calculation: Subscales are reverse scored (using formula 100 - a x 25) and then all subscales are averaged Eg: Subscale score of 3 is reverse scored as: 100 - (3 x 25) = 25 Interpretation: Higher score indicates better quality of life"|Baseline, 3 cycles|10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.|||Scores on a scale||Standard Error|Mean
1383377|NCT01428661|Primary|Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)|Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.|8 weeks|The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.|||units on a scale||Standard Error|Mean
1383400|NCT01428258|Other Pre-specified|Bone Mineral Density Determined by Dual-energy X-ray Absorptiometry (DXA) Scan|Subjects will have a single DXA test to assess bone mineral density of the lumbar spine and total body during the first dietary treatment that they are randomly assigned to start with.|once during first 3 week dietary treatment|||||||
1402098|NCT01246206|Secondary|Determine Incidence of Opportunistic Infections||Followed for up to two years post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1383378|NCT01428583|Other Pre-specified|Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. “Pain at its worst in the last 24 hours” was reported.|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||unit on a scale||Standard Deviation|Mean
1383379|NCT01428583|Other Pre-specified|Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours was reported."|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||unit on a scale||Standard Deviation|Mean
1383380|NCT01428583|Other Pre-specified|Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. “Pain right now” was reported.|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||units on a scale||Standard Deviation|Mean
1383381|NCT01428583|Other Pre-specified|Participants Global Assessment of Treatment Satisfaction|"Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question Please rate your overall satisfaction with the study drug you received?” where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied."|Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||unit on a scale||Standard Deviation|Mean
1383382|NCT01428583|Other Pre-specified|Mean Daily Dose of Immediate-release Oxycodone as Rescue Medication|Immediate-release oxycodone as a single ingredient product was used as a rescue medication only during the first 4 weeks of the treatment period to support the initiation of oxycodone HCl and naltrexone HCl treatment.|Up to Week 4|Data for mean daily dose of immediate-release oxycodone was not reported because as per protocol and analysis plan it was not planned to be summarized.||||||
1383383|NCT01428583|Other Pre-specified|Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above|The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior.|Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."|||percentage of participants|||Number
1383384|NCT01428583|Other Pre-specified|Percentage of Participants With Response to Urine Drug Test|Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed.|Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||percentage of participants|||Number
1383385|NCT01428583|Other Pre-specified|Number of Participants With Rescue Medication (Acetaminophen Tablets)|Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication.|Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Intent-to-treat (ITT) included all participants in the safety analysis set who had at least 1 pain intensity score reported during treatment. Here n signifies those participants who were evaluable at specified time point."|||participants|||Number
1383386|NCT01428583|Other Pre-specified|Mean Daily Dose of Study Medication (Oxycodone Component)||Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||milligram/day||Standard Deviation|Mean
1383387|NCT01428583|Other Pre-specified|Duration of Exposure to Study Medication|Duration of exposure to study medication during the course of the study was assessed.|Baseline up to 2 weeks after last dose|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||days||Full Range|Median
1383541|NCT01426438|Primary|Absolute Change in Relative FMD (%)|The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||% FMD||Inter-Quartile Range|Median
1383388|NCT01428583|Other Pre-specified|Time to Stabilization of Study Medication|Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1.|Baseline up to Month 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||days||Full Range|Median
1383389|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of 6-Beta-naltrexol|6-Beta-naltrexol was a metabolite of naltrexone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
1383390|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
1383391|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone|Noroxycodone was a metabolite of Oxycodone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
1383392|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
1383393|NCT01428583|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.|Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."|||units on a scale||Standard Deviation|Mean
1383394|NCT01428583|Secondary|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.|Baseline up to Month 12|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||percentage of participants|||Number
1383395|NCT01428583|Secondary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant’s usual function) and severe (interferes significantly with participant’s usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||participants|||Number
1383396|NCT01428583|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||participants|||Number
1383397|NCT01428336|Secondary|Peak Total Cortisol Values|Peak total cortisol values during cortrosyn stimulation tests(CST)|1 hour for the CST interventions and 2 hour for the ITT interventions||||ug/dl||Full Range|Median
1383398|NCT01428336|Secondary|Pearson Correlation of Free Cortisol Values During CSTs With ITT|Correlation of free cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table|1 hour for the CST interventions and 2 hour for the ITT interventions|Correlation of free cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.|||correlation coefficient||95% Confidence Interval|Number
1383401|NCT01428258|Secondary|N-terminal Telopeptide (NTX) Plasma Concentration at Day 22|Plasma concentration of NTX was determined as a measure of bone resorption; higher levels indicate greater bone breakdown|day 22 of each dietary treatment|Samples were not obtained from 3 subjects due to a collection error by research staff. Thus the sample size is reduced from 30 to 27.|||nmol per liter bone collagen equivalents||Standard Error|Mean
1383402|NCT01428258|Secondary|Bone-specific Alkaline Phosphatase (BSAP) Plasma Concentration at Day 22|Plasma concentration of BSAP was determined as a measure of bone turnover.|day 22 of each dietary treatment|Samples were not obtained from 4 subjects due to a collection error by research staff. Thus the sample size is reduced from 30 to 26.|||micro gram per liter||Standard Error|Mean
1383403|NCT01428258|Secondary|Comparison of Phe Concentrations in Plasma With Concentrations in Dried Blood Spots|Concentrations of Phe in plasma and in dried blood spots collected simultaneously by subjects will be compared using 2 methodologies, regardless of intervention. At each of the 4 study visits (baseline and final for each dietary treatment): 1) venipuncture was used to collect blood and plasma was isolated and analyzed for Phe with ion exchange chromatography and 2) subjects were asked right after the venipuncture to spot their blood on filter paper for analysis of Phe with tandem mass spectroscopy (MS/MS). The discrepancy in Phe concentrations with these 2 methods was compared for each sample pair using Bland-Altman statistical analysis. Each subject should have had 4 sample pairs, 29 x 4 = 116, but we ended up with only 110 sample pairs, as explained below.|4 times total, 2 per treatment|Analysis of sample pairs is required to determine the discrepancy in Phe levels with the 2 methods. Each subject should have had 4 sample pairs, 29 x 4 = 116, but we ended up with only 110 sample pairs. The explanation for the difference is that several subjects did not provide dried blood spots because research staff forgot to obtain them.|||micro moles per liter||Standard Error|Mean
1383404|NCT01428258|Secondary|Vitamin D (25-OH) Plasma Concentration at Day 22|Vitamin D was measured as a measure of the capacity for calcium absorption. Higher levels of plasma vitamin D are consistent with higher calcium absorption.|day 22 of each dietary treatment||||ng per ml||Standard Error|Mean
1383405|NCT01428258|Secondary|Executive Function Assessed by BRIEF|Completion of a standardized test, the Behavior Rating Inventory of Executive Function (BRIEF), by each subject for the GMP diet and the AA diet. Values are T-scores which have a mean of 50 points and a SD of 10 points. A T score of <50 is considered within the normative range. Data are analyzed with a paired t-test.|day 22 of each dietary treatment||||T score||Standard Error|Mean
1383406|NCT01428258|Secondary|Dietary Compliance|Compliance with the glycomacropeptide and amino acid dietary treatments will be assessed by comparison of the intake of medical food in grams of protein from medical food per day based on subject completion of 3-day food records prior to the final study visit on day 22. Statistical analysis for a dietary treatment effect will consist of ANOVA.|3 week dietary treatment||||g protein from MF/kg/day||Standard Error|Mean
1383407|NCT01428258|Primary|Change in the Plasma Phenylalanine Concentration of PKU Subjects Fed the Glycomacropeptide Diet Compared With the Change When Fed the Amino Acid Diet|Plasma will be collected at each base week and after 3 weeks on each of the dietary treatments, glycomacropeptide and amino acid, following an overnight fast. Plasma phenylalanine concentration (along with the complete profile of free amino acids) will be determined with an amino acid analyzer in the Wisconsin State Lab of Hygiene. Statistical analysis to determine the significance of the change in plasma phe concentration when comparing the 2 diets will consist of ANCOVA with covariates for baseline Phe and dietary Phe intake. The change in plasma Phe concentration from day 22 (final) to day 1 (baseline) was determined after adjusting for baseline Phe level and dietary Phe intake.|baseline to day 22 on each diet||||micro moles per liter plasma||Standard Error|Mean
1383408|NCT01428219|Secondary|Median Time to PSA Progression||18 months||||weeks||Full Range|Median
1383409|NCT01428219|Secondary|The Number of Patients That Are Progression Free by PSA|The number of patients that are progression free by PSA at 12 weeks|12 weeks||||Participants|||Count of Participants
1383410|NCT01428219|Secondary|Duration of Response.|Duration of response in soft tissue and bone.|18 months||||weeks||Full Range|Median
1383411|NCT01428219|Secondary|Response Proportion in Both Soft Tissue and Bone Disease.|The percentage of participants that respond in soft tissue and bone disease.|18 months||||percentage of participants|||Number
1383412|NCT01428219|Secondary|Progression-free Survival|The percentage of participants alive without progression at 12 weeks|12 weeks||||percentage of participants||95% Confidence Interval|Number
1383413|NCT01428219|Secondary|Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib|Mean fold change in markers of bone metabolism in bone and serum with cabozantinib. Bone biomarkers include Osteocalcin, NTx, TRAcP, BMP2, SOST, BAP, CICP|18 months||||unitless||Standard Deviation|Mean
1383414|NCT01428219|Secondary|Incidence of Adverse Events (AEs) Related to Treatment|The incidence of grades 1-3 AEs, by CTCAE 4.0 category, either possibly, probably or definitely related to treatment. The NCI Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for AE reporting.|18 months||||adverse events reported|||Number
1383415|NCT01428219|Primary|Percentage of Participants Who Remain Progression-free at 12 Weeks|Efficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study. RECIST 1.1 will be used to measure progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Kaplan-Meier methods will be used to report progression-free survival.|12 weeks after participant initiates study||||Percentage of participants||95% Confidence Interval|Number
1383416|NCT01428193|Primary|Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level|The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.|3 weeks after flutamide treatment|One subject completed the study but had not taken the study medication so her data is unusable. The second subject completed the study. However, no data were formally analyzed. We were subsequently unable to recruit any additional subjects.|||percentage of slope change|||Number
1383417|NCT01428128|Secondary|Complete Blood Count (CBC)|Another objective of this trial is to assess if arsenic protects the blood counts that are adversely affected by chemotherapy|Day 9 of chemotherapy|Data was not collected from CBC at 9 days||||||
1383418|NCT01428128|Primary|Dose of Arsenic That Blocks Activation of p53|A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.|Day 1 of chemotherapy||||mg/kg|||Number
1383593|NCT01425853|Secondary|Number of Participants With at Least One Adverse Events|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population|||number of participants|||Number
1383419|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) – Depression Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||participants|||Number
1383420|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) – Anxiety Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||participants|||Number
1383421|NCT01428115|Secondary|State Trait Anxiety Index (STAI) Trait Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||scores on a scale||Standard Deviation|Mean
1383422|NCT01428115|Secondary|State Trait Anxiety Index (STAI) State Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||scores on a scale||Standard Deviation|Mean
1383423|NCT01428115|Secondary|Harvey-Bradshaw Index (HBI) Scores by Visit|Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn’s disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||participants|||Number
1383424|NCT01428115|Secondary|Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit|The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||scores on a scale||Standard Deviation|Mean
1383425|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) – Depression, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||participants|||Number
1383426|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) – Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||participants|||Number
1383427|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||scores on a scale||Standard Deviation|Mean
1383428|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||scores on a scale||Standard Deviation|Mean
1383429|NCT01428076|Primary|Weight-adjusted Polidocanol Cmax (Serum)|Cmax measured and adjusted for weight|pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose|PK population|||ng/mL||Standard Deviation|Mean
1383430|NCT01428063|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Participants|||Number
1383431|NCT01428063|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.|Week 24 (Follow-up)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
1383432|NCT01428063|Secondary|Percentage of Participants With End of the Treatment Response (EOTR)|EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.|End of the study (Week 24)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
1383433|NCT01428063|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.|Week 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
1383434|NCT01428063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.|Week 4 and 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
1383435|NCT01428063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4|RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.|Week 4|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
1383436|NCT01428063|Secondary|Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis|||Percentage of participants||95% Confidence Interval|Number
1383437|NCT01428063|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)|SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.|Week 12 (Follow-up period)|Participants with genotype 1 HCV who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1383438|NCT01427933|Other Pre-specified|Number of Participants With Adverse Events (AE) and Participants Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to end of treatment and within 30 days of last dose of study drug (22.6 months)|All randomized participants who received at least 1 dose of study drug and according to the treatment received.|||participants|||Number
1383439|NCT01427933|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who developed treatment-emergent antibody responses after baseline. The antibody test can produce positive results in participants without ramucirumab exposure. Treatment emergent anti-ramucirumab antibody positive was defined as: when baseline titer was greater than 0 and post baseline titer was equal to or greater than 4-fold the baseline titer or if the baseline titer was not detected and post baseline titer is equal to or greater than a value of 20.|Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 months|All randomized participants who received at least 1 dose of study drug and assessed for treatment emergent antibodies.|||participants|||Number
1383440|NCT01427933|Secondary|Change in Tumor Size (CTS)|CTS was defines as the change from baseline measurement of target lesions to the post treatment measurement in participants with measurable disease. Change was assessed using radiographic imagining. Log ratio calculated as: log of (tumor size post baseline) divided by (tumor size at baseline). A negative result indicated a shrinking tumor.|Baseline, 6 weeks|All participants with measurable disease at baseline and at 6 weeks.|||log ratio||Standard Deviation|Mean
1383441|NCT01427933|Secondary|Duration of Response (DOR) Time of Response to Progressive Disease|DOR was measured from the time criteria were met for first objectively recorded CR or PR until first date criteria for PD was met or death. Response defined using RECIST v1.1 criteria. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of diameter (SOD) of target lesions. PD defined ≥20% increase in SOD of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time from Observed CR or PR to PD up to 12.1 months|ITT population: all participants according to their randomized treatment group and who had CR or PR. Participants censored: Ramucirumab+Eribulin=1, Eribulin=3.|||months||95% Confidence Interval|Median
1383470|NCT01427803|Secondary|Non-therapeutic Reasons for Misuse|Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.|28 days|Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis|||Participants|||Number
1383442|NCT01427933|Secondary|Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)|ORR was defined as the percentage of participants with measurable disease achieving a best overall response of PR or CR as defined by RECIST v.1.1. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in SOD of target lesions. Participants who did not have any post baseline tumor response assessments for any reason were considered non-responders and included in the denominator when calculating the response rate. ORR for each treatment arm calculated as: [(CR + PR in the treatment arm) divided by (total number of participants in the treatment arm)] x 100.|Start of treatment until documented CR or PR up to 16.5 months|ITT population: all participants according to their randomized treatment group.|||percentage of participants||95% Confidence Interval|Number
1383443|NCT01427933|Secondary|Overall Survival (OS) Randomization to Date of Death From Any Cause|Time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date, OS data were censored on the last date the participants were known to be alive prior to that cut-off date.|Randomization to date of death from any cause up to 28.6 months|ITT Population: All randomized participants. Participants censored: Ramucirumab and Eribulin=24 , Eribulin Monotherapy=28|||Months||95% Confidence Interval|Median
1383444|NCT01427933|Primary|Progression‐Free Survival (PFS)|PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.|Start of treatment until documented disease progression or death from any cause up to 16.5 months|Intent-to-treat Population (ITT): all participants according to their randomized treatment group. Participants censored: Ramucirumab+Eribulin=14; Eribulin=17.|||months||95% Confidence Interval|Median
1383445|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 17 subjects did not contribute to data.|||scores on a scale||Standard Deviation|Mean
1383446|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 4|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 20 subjects did not contribute to data.|||scores on a scale||Standard Deviation|Mean
1383447|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 0|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 10 subjects did not contribute to data.|||scores on a scale||Standard Deviation|Mean
1383448|NCT01427920|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to week 20|Safety analysis set included all subjects who received at least one dose of BIAsp 30. One subject did not contribute to data.|||episodes|||Number
1383449|NCT01427920|Secondary|Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)|Estimated mean change from baseline in FPG after 20 Weeks of treatment|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.|||mmol/L||Standard Error|Least Squares Mean
1383450|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - PP|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.|Week 0, week 20|Per protocol (PP) analysis set - analysis included subjects exposed to BIAsp 30 for more than 12 weeks without any major protocol violations. 24 subjects did not contribute to the statistical analysis after Week 20.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1383451|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - FAS|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 Weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1383452|NCT01427907|Primary|Serum Phosphorus Levels|The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject|2 weeks|Modified intent-to-treat: subjects who were randomized, received at least one prescribed dose of the study medication and provided at least one of the last 4 laboratory assessments of each treatment period|||mg/dL||Standard Deviation|Mean
1383532|NCT01426438|Secondary|Change in Large HDL Particles|Change in Large HDL Particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||nmol/L||Inter-Quartile Range|Median
1383453|NCT01427881|Secondary|Graft Failure|Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of >= 500/uL by >= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to < 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.|By greater than or equal to 28 days post-transplant||||percentage of patients|||Number
1383454|NCT01427881|Secondary|Hematologic Recovery|Descriptive statistics will be used to assess the median days of neutrophil and platelet recovery. The day of neutrophil recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the absolute neutrophil count is > 500/uL. The day of platelet recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the platelet count is >= 20,000/uL without platelet transfusion support in the seven days prior.|Up to day +100||||days||Full Range|Median
1383455|NCT01427881|Secondary|Disease-free Survival|Disease-free survival will be evaluated as Kaplan-Meier estimates.|At 1 year post-transplant||||percentage of patients||95% Confidence Interval|Number
1383456|NCT01427881|Secondary|Overall Survival|Overall survival will be evaluated as Kaplan-Meier estimates.|At 1 year post-transplant||||percentage of patients||95% Confidence Interval|Number
1383457|NCT01427881|Secondary|Non-relapse Mortality|Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence.|At 2 years||||percentage of patients||95% Confidence Interval|Number
1383458|NCT01427881|Secondary|Persistent or Recurrent Malignancy After HCT|Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation.|At 2 years||||percentage of patients||95% Confidence Interval|Number
1383459|NCT01427881|Secondary|Duration of Systemic Immunosuppressive Treatment|The need for additional immunosuppressive treatment with agents other than those used for prophylaxis, the reasons for their administration (acute GVHD, chronic GVHD, or other reasons) and the duration of its administration will be determined. Patients will be monitored to determine the duration of systemic immunosuppressive treatment. Primary and secondary treatment of acute GVHD and withdrawal of systemic immunosuppressive treatment will be assessed with the use of cumulative incidence plots.|Up to 5 years|This data was not collected.||||||
1383460|NCT01427881|Secondary|Grades II-IV and III-IV Acute GVHD|Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.|Through day +100 post-transplant||||percentage of patients|||Number
1383461|NCT01427881|Secondary|Donor Engraftment|Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood.|At day 28||||Participants|||Count of Participants
1383462|NCT01427881|Primary|Chronic GVHD Requiring Systemic Immunosuppressive Treatment|Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from ~35% to ~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.|At 1 year after transplantation||||percent of patients||95% Confidence Interval|Number
1383463|NCT01427803|Secondary|Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of dosing occasions|Participants||Number
1383464|NCT01427803|Secondary|Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of participants|||Number
1383465|NCT01427803|Secondary|Percentage of Dosing Occasions Where More Than One Tablet Was Taken|Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of dosing occasions|Participants||Number
1383466|NCT01427803|Secondary|Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken|Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of participants|||Number
1383467|NCT01427803|Secondary|Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day|Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product|||Percentage of participants|||Number
1383468|NCT01427803|Secondary|Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days|Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product|||Percentage of participants|||Number
1383469|NCT01427803|Secondary|Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course|This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by “use day”. A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive “evaluable days.”|28 days|Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population|||Percentage of participants|||Number
1383652|NCT01425528|Secondary|Hamilton Depression Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
1383471|NCT01427803|Primary|Estimated Percentage of Misuse for Non-Therapeutic Reasons|The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.|28 days|Participants in Patterns of Use cohort who took the product + Participants in Reason for Misuse cohort who completed interview|||Percentage of Participants|||Number
1383472|NCT01427751|Secondary|Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure|Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.|12 Months|Intent-to-treat population included all randomized participants.|||percentage of participants|||Number
1383473|NCT01427751|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)|The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1383474|NCT01427751|Secondary|Time to BCVA Improvement of 15-or-More Letters|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.|12 Months|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||days||Standard Deviation|Mean
1383475|NCT01427751|Secondary|Percentage of Patients With a 15-or-More Letter Decrease in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||percentage of participants|||Number
1383476|NCT01427751|Secondary|Percentage of Patients With 15-or-More Letter Improvement in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||percentage of participants|||Number
1383477|NCT01427751|Secondary|Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||microns||Standard Deviation|Mean
1383478|NCT01427751|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||letters||Standard Deviation|Mean
1383479|NCT01427738|Secondary|Number of Participants Who Found GV and Nystatin Acceptable.|Acceptability was defined as the willingness to use the drug if it is proven effective to treat oral candidiasis. Participants were asked whether or not they would be willing to use the assigned treatment via questionnaires.|After 14 days of treatment|The analysis for acceptability of treatment was based on 209 subjects.|||participants|||Number
1383480|NCT01427738|Secondary|Self-Assessment of General Health|Participants rated their general health on two scales. One is a five point scale ranging from 1 to 5 (1=Excellent; 2=Very Good; 3=Good; 4=Fair; 5=Poor)|Weeks 0, 6|N=110 (GV), 110 (Nystatin) wk 0 N= 96 (GV), 95 (Nystatin) wk 6|||participants|||Number
1383481|NCT01427738|Secondary|Number of Participants Who Were Adherent.|Adherence was reported as a dichotomous variable (adherence vs. non-adherence). Participants who have missing doses less than 15% will be considered as adherent, i.e., if a participant is in the GV arm, then the cutoff point is 28*0.15=4 doses; and for the nystatin arm is 56*0.15=8 doses.|After 14 days of treatment|The analysis for adherence was based on 209 observations.|||participants|||Number
1383482|NCT01427738|Secondary|Tolerance|The investigators will measure tolerance using a scale from 0 to 3 (0=No side effects experienced, no changes in treatment; 1=Some side effects experienced, but not enough to modify treatment; 2=Some side effects experienced, resulted in treatment interruption; 3=Side effects experienced, resulted in treatment discontinuation.)|After 14 days of treatment|The analysis for tolerance was based on 208 observations.|||participants|||Number
1383483|NCT01427738|Secondary|Quantitative Yeast Colony Counts|If quantitative yeast culture yielding < 20 CFU/mL of Candida spp., then we call this mycological success|At weeks 0, 2, 6|"At entry, 210 observations were available (182 had positive culture result for Candida specimen, and 175 of those had colony count performed) to evaluate quantitative yeast colony counts.~N= 78 (GV), 70 (Nystatin) at end of treatment; N= 51 (GV), 35 (Nystatin) at week 6;"|||CFU/mL||Standard Deviation|Mean
1383484|NCT01427738|Secondary|Number of Participant With Symptom|Symptoms were assessed using a visual analog scale where the level of discomfort and pain were recorded and quantified using a scoring system from 0 to 3. 0=no discomfort/pain; 1=mild discomfort/pain; 2=Moderate discomfort/pain; 3=Severe discomfort/pain.|after 14 days of treatment|At entry, a total of 217 observations (106 in GV arm; 111 in nystatin arm) were available to evaluate the symptoms (pain and discomfort) associated with OC. At the end of treatment, a total of 204 observations were available to evaluate the symptoms associated with OC using extended Mantel-Haenszel test between GV and nystatin arms.|||participants|||Number
1383653|NCT01425528|Secondary|Hamilton Anxiety Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
1383485|NCT01427738|Primary|Number of Participants With Clinical Efficacy|The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.|After 14 days of treatment|Out of 221 subjects,17 had oral exams at entry but not week 2: 11 premature discontinuation, 2 missed visits, and 4 without specific reasons. 204 subjects received oral exams at both entry and week 2. 2 more participants were excluded from the final analysis because they had no pseudomem candi at entry, which led to a total of 202 subjects.|||participants|||Number
1383486|NCT01427517|Primary|Brain GSH|change in brain GSH levels from baseline to post-NAC administration (90 - 110 minutes) in all subjects|Baseline and up to 110 minutes post-NAC administration||||percent increase from baseline||Standard Deviation|Mean
1383487|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
1383488|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
1383489|NCT01427504|Primary|Etravirine AUC Pharmacokinetics Coadministered With Boceprevir|Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
1383490|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics Coadministered With Etravirine|Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
1383491|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine|Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
1383492|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics Coadministered With Etravirine|Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
1383493|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics|Determine etravirine Cmin when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1383494|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics|Determine etravirine Cmax when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1383495|NCT01427504|Primary|Etravirine AUC Pharmacokinetics|Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1383496|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics|Determine boceprevir 8 hour concentration when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1383497|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics|Determine the Cmax of boceprevir when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1383498|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics|Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants was based on the number of subjects that completed all three sequences of medication.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1383499|NCT01427309|Other Pre-specified|Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period|All serious adverse events, including deaths and adverse events (AEs) of special interest (Guillain Barre Syndrome, Bell's Palsy, encephalitis/myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis) were collected.|Day 0 up to Day 240 post-vaccination|Safety was assessed in the Full Analysis Set.|||Participants|||Number
1383533|NCT01426438|Secondary|Change in Small LDL Particles|Change in Small LDL particles from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||nmol/L||Inter-Quartile Range|Median
1383500|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture).~Respiratory illness is defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1383501|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~Respiratory illness was defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1383502|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1383503|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1383504|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness|"For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture).~A protocol-defined influenza-like illness (ILI) was determined by the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a protocol-defined influenza-like illness was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1383505|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)|Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type–specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture. For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).|||Participants|||Number
1383534|NCT01426438|Secondary|Change in LDL Cholesterol|Change in LDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
1383506|NCT01427309|Primary|Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).|"Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type–specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration through a 510K evaluation for specific detection of Influenza A, B or Respiratory Syncytial Virus.~A protocol-defined influenza-like illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).|||Participants|||Number
1383507|NCT01427296|Primary|Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.||6 months||||Participants|||Count of Participants
1383508|NCT01426958|Primary|Area Under Curve From 0 to ∞ Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1383509|NCT01426958|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1383510|NCT01426958|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1383511|NCT01426867|Primary|Mean Ocular Discomfort Score|Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).|Week 1|Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.|||Units on a scale||Standard Deviation|Mean
1383512|NCT01426854|Secondary|Proportion of Subjects Who Were Pain-Free at All Postoperative Visits|Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.|Up to Day 14|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.|||Percentage of subjects|||Number
1383513|NCT01426854|Primary|Proportion of Subjects With Clinical Cure at Day 14|Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.|Day 14 postoperative|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.|||Percentage of subjects|||Number
1383514|NCT01426789|Secondary|Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis. Statistical analysis was not done on the other biomarkers: osteoprotegerin (OPG), rheumatoid factor (RF), anti-cyclic citrullinated peptide antibodies (CCP) and hsCRP. Therefore, data is provided for the alleles only.|||score on a scale||Standard Error|Least Squares Mean
1383535|NCT01426438|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
1383536|NCT01426438|Secondary|Change in HDL Particles|Change in total HDL particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||nmol/L||Inter-Quartile Range|Median
1383515|NCT01426789|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.|||Percentage of participants|||Number
1383516|NCT01426789|Primary|Change From Baseline in Disease Activity Score 28 (DAS28) in Association With the Presence or Absence of HLA-DRB1 04|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
1383517|NCT01426789|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.|||Percentage of participants|||Number
1383518|NCT01426763|Secondary|Number of Subjects With C1 INH Antibodies||Through 30 days after final dose|||||||
1383519|NCT01426763|Secondary|C1 Inhibitor (C1 INH) and C4 Levels||18 days|||||||
1383520|NCT01426763|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study||18 days||||participants|||Number
1383521|NCT01426555|Secondary|Validation of DXA Scanning in Patients With SCI|This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia.|12 months|Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB.||||||
1383522|NCT01426555|Primary|Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure|This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid.|12 months|Data was never analyzed because the study was closed by the VABHS IRB. Full dataset is unavailable for analysis.||||||
1383523|NCT01426516|Secondary|Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey|To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder|6 months|||||||
1383524|NCT01426516|Secondary|Cost|To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.|6 months|||||||
1383525|NCT01426516|Secondary|Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.|baseline, 3, 6 months|||||||
1383526|NCT01426516|Secondary|Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.|Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.|one week|||||||
1383527|NCT01426516|Primary|Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months|"To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months~Add:~highest score on any 1 of the 4 sleep items (items 1 to 4)~highest score on any 1 of the 4 weight items (items 6 to 9)~highest score on either of the 2 psychomotor items (15 and 16)~scores for each of the 6 MDD symptom domains~Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression"|6 months|Invalid Data Collection||||||
1383528|NCT01426438|Secondary|Change in D-Dimer|Change in D-Dimer from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||ug/ml||Inter-Quartile Range|Median
1383529|NCT01426438|Secondary|Change in C-reactive Protein (CRP)|Change in C-reactive protein from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||ug/ml||Inter-Quartile Range|Median
1383530|NCT01426438|Secondary|Change in IL-6|Change in IL-6 from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||pg/ml||Inter-Quartile Range|Median
1383531|NCT01426438|Secondary|Change in HOMA-IR|Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||HOMA IR Score||Inter-Quartile Range|Median
1383542|NCT01426425|Secondary|Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.|If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.|6 Months|The 378 mITT subjects who had acute procedural success with cryoablation for the treatment of AVNRT are included in this analysis.|||Participants|||Count of Participants
1383543|NCT01426425|Primary|Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.|Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.|6 Months|The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.|||Participants|||Count of Participants
1383544|NCT01426425|Primary|Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.|"Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success:~Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment.~Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure."|6 months|The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.|||Participants|||Count of Participants
1383545|NCT01426386|Secondary|Frequency and Intensity of Adverse Events||From signing informed consent form until end of trial visit (up to 5 months)|Safety population (all randomised and exposed subjects). This is equivalent to the mITT|||participants|||Number
1383546|NCT01426386|Secondary|Clinical Pregnancy With Fetal Heart Beat Rate|Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat|5-6 weeks after transfer|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||percentage||95% Confidence Interval|Number
1383547|NCT01426386|Secondary|Number and Quality of Blastocysts on Day 5|Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher|Day 5 after oocyte retrieval|Subjects with oocytes retrieved|||Blastocysts||Standard Deviation|Mean
1383548|NCT01426386|Secondary|Number of Fertilised Oocytes|An oocyte with 2 pronuclei was regarded as correctly fertilised|Day 1 after insemination|Subjects with oocytes retrieved|||Fertilised oocytes||Standard Deviation|Mean
1383549|NCT01426386|Secondary|Total IMP Dose||End of stimulation (up to 16 stimulation days)|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||µg||Standard Deviation|Mean
1383550|NCT01426386|Secondary|Endocrine Profile|Estradiol at end of stimulation|End of stimulation (up to 16 stimulation days)|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||pmol/L||Standard Deviation|Mean
1383551|NCT01426386|Secondary|Number and Size of Follicles During Stimulation|Follicular volume at end of stimulation|End of stimulation (up to 16 stimulation days)|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||cm^3||Standard Deviation|Mean
1383552|NCT01426386|Primary|Number of Oocytes Retrieved||Day of oocyte retrieval (up to Day 18 after start of stimulation)|Modified Intention-to-treat (mITT) population (all randomised and exposed subjects). This is equivalent to the Full Analysis Set (FAS)|||Oocytes||Standard Deviation|Mean
1383553|NCT01426373|Secondary|Change From Baseline in Line Drawing Assessment|Each participant was given 2 example line drawings representing each of the 5 submental fat grades (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme) and asked to select the drawing that best represents their current profile. Improvement is any decrease in grade, and worsening is any increase in grade.|Baseline and month 3 after last treatment|Treatment effect population with available data|||participants|||Number
1383554|NCT01426373|Secondary|Change From Baseline in Submental Skin Laxity Grade (SMSLG)|"SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds).~Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy (no skin draping (vertical folds) or skin sagging (horizontal folds));~Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy (slight skin draping and sagging);~Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy (moderate skin draping and skin sagging);~Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy (marked skin draping and sagging)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"|||units on a scale||Standard Deviation|Mean
1383555|NCT01426373|Secondary|Percent Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured using calipers.|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (164) and at each time point|||percent change||Standard Deviation|Mean
1383654|NCT01425528|Primary|Change in Neurotransmitter Metabolite Levels in Cerebral Spinal Fluid||Baseline, 8 wks, 12 wks|||||||
1383556|NCT01426373|Secondary|Response to Subject Global Questions|"Participants answered 3 questions on a 7-point scale that ranged from a great deal worse to a great deal better (questions 1 and 2) or from extremely dissatisfied to extremely satisfied (question 3).~Question 1: Since the start of the study, how would you rate the fat under your chin right now?~Question 2: Since the start of the study, how would you rate the definition between your chin and neck right now?~Question 3: How satisfied are you with the treatment you received in this study?"|Month 3 and month 12 after last treatment|Treatment effect population with available data at each time point|||participants|||Number
1383557|NCT01426373|Secondary|Mean Change From Baseline in Self-rating of Attractiveness|"Self-rating of Attractiveness assesses aspects of appearance from the participant's perspective with a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 (1 = not at all attractive, 5 = neither attractive nor unattractive, and 9 = extremely attractive). A positive change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (163), month 3 (144), and month 12 (130)|||units on a scale||Standard Deviation|Mean
1383558|NCT01426373|Secondary|Mean Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 (0 = extremely dissatisfied, 1 = dissatisfied, 2 = slightly dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = slightly satisfied, 5 = satisfied and 6 = extremely satisfied). A positive change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"|||units on a scale||Standard Deviation|Mean
1383559|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and each time point (indicated by n)"|||units on a scale||Standard Deviation|Mean
1383560|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"|||percentage of participants|||Number
1383561|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.~The CR-SMFRS score is based on the investigator’s clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"|||percentage of participants|||Number
1383562|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat). A negative change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline (163) and at each time point (indicated by n)"|||units on a scale||Standard Deviation|Mean
1383563|NCT01426373|Secondary|Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement.|Baseline and months 3, 6, 9, and 12 after last treatment|"Treatment effect population (all participants who received at least 1 injection with study drug and had any posttreatment data for treatment effect variables or for the submental skin laxity grade) and with available data at each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1383564|NCT01426373|Primary|Number of Participants With Adverse Events (AEs)|"Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard.~The severity of each AE was defined as either:~Mild: The participant was aware of the sign or symptom, but it was easily tolerated.~Moderate: The sign or symptom caused discomfort and interfered with usual activity.~Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity.~The investigator determined the relationship of each AE to the study drug using the question: “Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"|Up to 12 months after last treatment (maximum of 18 months from first treatment)|Safety population|||participants|||Number
1383657|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8||From Baseline to Week 8|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
1383565|NCT01426360|Primary|Air Blast Hypersensitivity Score 3 Days After Dentifrice Use|"After 3 days, tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.~0 - Subject does not respond to air stimulus;~- Subject responds to air stimulus, but does not request discontinuation of stimulus;~- Subject responds to air stimulus and requests discontinuation or moves from stimulus;~- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|3 days after dentifrice use||||scale||Standard Deviation|Mean
1383566|NCT01426360|Primary|Tactile Hypersensitivity Score After 3 Days of Dentifrice Use|After 3 days, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified, reproducible force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|3 days after dentifrice use||||gram||Standard Deviation|Mean
1383567|NCT01426360|Primary|Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use|"The tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at the exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.~0 - Subject does not respond to air stimulus;~- Subject responds to air stimulus, but does not request discontinuation of stimulus;~- Subject responds to air stimulus and requests discontinuation or moves from stimulus;~- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|immediately after dentifrice use||||scale||Standard Deviation|Mean
1383568|NCT01426360|Primary|Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use|Immediately after dentifice use, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|immediately after dentifrice use||||gram||Standard Deviation|Mean
1383569|NCT01426347|Secondary|Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)|In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.|Baseline and 16 weeks (end of RCT)|For placebo, analysis is based on 26 at baseline and 33 at the end of RCT For treatment, analysis is based on 27 at baseline and 38 at the end of RCT|||units on a scale||Standard Deviation|Mean
1383570|NCT01426347|Primary|Disease Activity Score (DAS) 28|"We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group.~We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity.~We used the following cut-offs: Remission (< 2.6), low disease activity (< 3.2), moderate disease activity (< 5.1) and high disease activity (> 5.1)."|Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))||||composite score||Standard Deviation|Mean
1383571|NCT01426269|Other Pre-specified|Period 1: Tolerability (Dryness)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)||||participants|||Number
1383572|NCT01426269|Other Pre-specified|Period 1: Tolerability (Stinging/Burning)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)||||participants|||Number
1383573|NCT01426269|Other Pre-specified|Period 1: Tolerability (Scaling)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)||||participants|||Number
1383574|NCT01426269|Secondary|Period 2: Inflammatory Lesion Count|The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.|Period 2 (40 Weeks)||||lesions||Standard Deviation|Mean
1383575|NCT01426269|Secondary|Period 2: Clinician's Erythema Assessment|The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score.|Period 2 (40 Weeks)||||units on a scale||Standard Deviation|Mean
1383576|NCT01426269|Secondary|Period 2: Investigator's Global Assessment Success|The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score).|Period 2 (40 weeks)||||participants|||Number
1383577|NCT01426269|Primary|Period 2: Number of Subjects Who Relapsed|"Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria:~A return to the baseline lesion count~A return to the baseline IGA score~The investigator determines that a change in rosacea treatment is warranted due to the subject’s clinical condition. The numbers reported here are accumulative numbers for each arm."|Period 2 (40 weeks)||||participants|||Number
1383578|NCT01426230|Primary|Change From Baseline to End of Study in LOCF VAS|"Change from baseline in pain score on visual analog scale (VAS) (intensity scored from No Pain (0mm) to Worst Possible Pain (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis"|8 weeks (Baseline and Week 8)|The Number of Participants Analyzed was based on the available VAS.|||scores on a scale||95% Confidence Interval|Mean
1383655|NCT01425528|Primary|Change in BH4 Levels in Cerebral Spinal Fluid|Identify dosing range of oral Kuvan® necessary and sufficient to normalize CSF BH4 levels in adults with GTPCH Deficiency.|Baseline, 8 wks, 12 wks|Data from 4 of 6 participants was analyzed for Kuvan Cohort 1 and for Kuvan Cohort 2 for this outcome measure. 2 participant withdrew, 1 participant's diagnosis was reclassified and we were unable to obtain baseline CSF on 1 participant.|||nmol/L||Standard Deviation|Mean
1383579|NCT01426113|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 6|Due to early termination of the study, no statistical analysis was performed and no data summaries were generated. From a target of 120 patients, only 6 patients (3 in each group) were enrolled.||||||
1383580|NCT01426009|Secondary|Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)|percentage of subjects with clinically meaningful change from pre-dose in trough FEV1 on Day 1 and Day 7 Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||percentage of participants|||Number
1383581|NCT01426009|Secondary|Rescue Medication Use|Mean number of puffs of daily rescue medication|Day 1 through Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||average daily number of puffs||Standard Deviation|Mean
1383582|NCT01426009|Secondary|Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. Vital signs were performed during the screening period to confirm study eligibility and at the final study visit. ECGs were performed during the screening period to confirm study eligibility. Vital signs and ECG were additionally collected within 30 minutes pre-dose; and 30 minutes, and 1, 2, 4, 6, 12 hours, and 23 hours 45 minutes post-dose within each treatment period. Clinical laboratory assessments were conducted during the screening period, at each study visit during each treatment period, and at the final study visit.|Day 1 through Day 7|All subjects who received at least one dose of study medication were included in the safety analysis.|||Participants|||Count of Participants
1383583|NCT01426009|Secondary|Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Clinically meaningful is defined as when the change from baseline (mean of the two pre-dose values at Day 1) in 24 hour trough FEV1 on a SUN-101 treatment is more than 100 mL compared to the mean change in trough FEV1 from all subjects on the placebo treatment.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||number of participants|||Number
1383584|NCT01426009|Secondary|Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||liters||Standard Deviation|Mean
1383585|NCT01426009|Primary|Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized FEV1 AUC(0-12hr and 12-24hr) on Day 1 and Day 7 was calculated using the trapezoidal rule from the changes in FEV1 at Day 1 and Day 7, respectively, from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||liters||Standard Deviation|Mean
1383586|NCT01426009|Primary|Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and Day 7.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent to treat analysis set|||liters||Standard Deviation|Mean
1383587|NCT01425879|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment||||months||95% Confidence Interval|Mean
1383588|NCT01425879|Secondary|Overall Survival|Analyzed using Kaplan-Meier method.|From study initiation to time of death, assessed up to 4 weeks after completion of study treatment||||months||95% Confidence Interval|Median
1383589|NCT01425879|Secondary|Frequency of Adverse Events Related to MK-2206|Severity of adverse events is graded according to the NCI CTCAE 4.0.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year||||percentage of patients|||Number
1383590|NCT01425879|Primary|Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year||||patients|||Number
1383591|NCT01425853|Secondary|Biomarker Analysis|The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2|6 months|||||||
1383592|NCT01425853|Secondary|Number of Adverse Events Defined by Relationship With Treatment|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population|||number of events|||Number
1402509|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days||||gm/dL||95% Confidence Interval|Mean
1383594|NCT01425853|Secondary|Health Status According to EuroQoL|"EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits.~The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3.~The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘Best imaginable health state’ and ‘Worst imaginable health state’. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.~Total scale range for VAS dimension reported is 0 to 100."|6 months|ADO on PP population|||points||Standard Deviation|Mean
1383595|NCT01425853|Secondary|Patient’s and Investigator's Global Assessment of Response to Therapy|The investigator were asked to evaluated the patient’s response to therapy of the index knee by marking a (I) a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Left hand marker “Excellent-Best possible anticipated response, considering the severity and stage of the disease”, right hand marker “None-no response, absence of drug effect”.|6 months|Investigator and Patient's global assessment assessment of response to therapy. ADO on PP population.|||units on a scale||Standard Deviation|Mean
1383596|NCT01425853|Secondary|Patient’s Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity|Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: “Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing.” Left hand marker “Very Well”, Right hand marked “Very Poor”.|6 months|Patient and Investigator's global assessment of disease activity. ADO on PP population|||units on a scale||Standard Deviation|Mean
1383597|NCT01425853|Secondary|Consumption of Rescue Medication|"Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary.~Total Number of pills per month"|6 months|Consumption of rescue medication (number of daily tablets consumed). ADO on PP population. daily tablets consumed/month|||daily tablets consumed/month||Standard Deviation|Mean
1383598|NCT01425853|Secondary|Percentage of Presence of Joint Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population|||percentage of participants|||Number
1383599|NCT01425853|Secondary|Percentage of Presence of Joint Swelling|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population|||percentage of participants|||Number
1383600|NCT01425853|Secondary|Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)|"The OARSI Standing Committee for Clinical Trials Response Criteria Initiative and the OMERACT committee, in concert with the international rheumatology community, has led to the development of a uniform core set of outcome measures for OA. One of the objectives was to propose a set of criteria for measurement based on multiple domains to present the results of changes after treatment in symptomatic parameters as a single variable for clinical trials.~To be considered as responder patients should met one the following criteria:~High improvement in pain or in function ≥ 50% and absolute change ≥ 20 or~Improvement in at least 2 of the 3 following:~Pain ≥ 20% and absolute change ≥ 10~Function ≥ 20% and absolute change ≥ 10~Patient’s global assessment ≥ 20% and absolute change ≥ 10"|6 months|ADO on PP population|||percentage of participants|||Number
1383601|NCT01425853|Secondary|Huskisson’s VAS|Visual Analogue Scale: 0 No Pain 100 Maximum Pain Huskisson’s VAS measures global pain intensity. Patients were asked to quantify their disease status on a 100 mm VAS as follows: “Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line”. Left hand marker represents “No pain” and right hand marker represents “The worst pain imaginable”.|6 months|ADO on PP population|||units on a scale||Standard Deviation|Mean
1383602|NCT01425853|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 1700 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.|6 months||||units on a scale||Standard Deviation|Mean
1383603|NCT01425853|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 200 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.|6 months|ADO on PP population|||units on a scale||Standard Deviation|Mean
1383604|NCT01425853|Primary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.|6 months|Imputed data on PP population|||units on a scale||Standard Deviation|Mean
1383605|NCT01425814|Secondary|Absolute Inspiratory Capacity (IC) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383606|NCT01425814|Secondary|Change From Baseline in Inspiratory Capacity (IC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383607|NCT01425814|Secondary|Time to Peak Forced Vital Capacity (FVC)|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Error|Mean
1383608|NCT01425814|Secondary|Change From Baseline in Peak Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383609|NCT01425814|Secondary|Absolute Forced Vital Capacity (FVC) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383610|NCT01425814|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383611|NCT01425814|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383612|NCT01425814|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383613|NCT01425814|Secondary|Time to Peak Forced Expiratory Volume in One Second (FEV1)|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Error|Mean
1383614|NCT01425814|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383615|NCT01425814|Secondary|Absolute Forced Expiratory Volume in One Second (FEV1) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383616|NCT01425814|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383656|NCT01425463|Secondary|Percentage of Responders at Week 12|Responders are defined as having an increment of Hemoglobin (Hb) > 15 g/L and post-treatment Hb > 120 g/L (male) or > 110 g/L (female) at Visit 6 (Week 12).|End of Treatment Period (Week 12)|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||percentage of participants|||Number
1383617|NCT01425814|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383618|NCT01425814|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383619|NCT01425801|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383620|NCT01425801|Secondary|Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383621|NCT01425801|Secondary|Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)|FVC was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383622|NCT01425801|Secondary|Change From Baseline to Trough Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +23 h +24 h post-dose|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383623|NCT01425801|Secondary|Time to Peak Forced Vital Capacity (FVC)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Deviation|Mean
1383624|NCT01425801|Secondary|Peak Forced Vital Capacity (FVC)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383679|NCT01425307|Secondary|Primary Stroke Events|This secondary outcome measure will compare standard to alternative therapy for primary stroke events (a) primary ischemic stroke; b) primary hemorrhagic stroke|24 months|||||||
1383625|NCT01425801|Secondary|Change From Baseline in Peak Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383626|NCT01425801|Secondary|Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Percent change||Standard Error|Least Squares Mean
1383627|NCT01425801|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383628|NCT01425801|Secondary|Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383629|NCT01425801|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1|FEV1 was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383630|NCT01425801|Secondary|Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +23 h and +24 h post-dose|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383631|NCT01425801|Secondary|Time to Peak Forced Expiratory Volume in One Second (FEV1)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Deviation|Mean
1383632|NCT01425801|Secondary|Peak Forced Expiratory Volume in One Second (FEV1)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383633|NCT01425801|Secondary|Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Percent change||Standard Error|Least Squares Mean
1383634|NCT01425801|Primary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
1383635|NCT01425749|Secondary|A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).|Cells per mm^2 in the superficial dermis at the vaccine site microenvironment, by enumeration of immunohistochemically stained slides. Biopsies of the vaccine sites were taken at week 1 (1 week after the first vaccine) and week 7 (1 week after the 3rd vaccine). This only was evaluable in Arm B patients.|Over 6 months|Participants enrolled on Arm B who had sufficient biopsy site samples.|||cells per mm^2 of dermis||Standard Deviation|Mean
1383636|NCT01425749|Secondary|Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.|Number of CD83+ cells (mature DC) and CD1a+ cells (immature DC/Langerhans cells) per mm^2 in cross-sections of sentinel immunized nodes|Over 3 weeks|Evaluable patients with sufficient node sample for the analysis of DC infiltrates.|||cells per mm^2 in SIN||Standard Deviation|Mean
1383637|NCT01425749|Secondary|Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.|Antibody responses were assessed in serum by ELISA, assay for IgG. Seroconversion was defined as a detectable Ab response by ELISA (>20 EU/ml).|Over 6 months, typically weeks 1, 7, 13, 26|All eligible participants.|||percentage of evaluable participantes|||Number
1383638|NCT01425749|Secondary|Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.|The analysis determined the proportion of CD4+ (and/or CD8+) T cells producing IFN-gamma or TNFα, or both, in response to MAGE-A3 peptide pools (with irrelevant peptide as negative control). T cell response was defined when T cells producing both IFNγ and TNFα in response to MAGE-A3 peptides exceeded (a) twice the maximum of 2 negative controls (PRAME peptides, media only), corrected for pre-existing response; and (b) exceeded the negative controls by at least 0.2% of the T cell population. These criteria also were used to define immunogenicity by ELIspot (IFNγ only). If the negative control values for a given sample were zero, a meaningful fold-increase could not be calculated; so, in those cases, we used the minimum detectable value among all similar assays (0.06%) as the negative control value for that sample.|Over 6 months|All eligible patients with evaluable peripheral blood mononuclear cells; this corresponds to all enrolled patients.|||participants|||Number
1383639|NCT01425749|Primary|Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.|Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.|One week after 3 doses of study drug, on day 22.|Eligible participants with evaluable sentinel immunized node specimens.|||participants|||Number
1383640|NCT01425749|Primary|Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability|grade 2 treatment-related adverse events graded by CTCAE v4|Over 6 months|All eligible patients.|||participants|||Number
1383641|NCT01425632|Secondary|Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)||Week 2|||||||
1383642|NCT01425632|Secondary|Adverse Events and Adverse Drug Reactions||Week 2|||||||
1383643|NCT01425632|Secondary|Change From Baseline in Severity Score||Week 2|||||||
1383644|NCT01425632|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Week 2|||||||
1383645|NCT01425632|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||Week 2|||||||
1383646|NCT01425632|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||Week 2|||||||
1383647|NCT01425632|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .|Baseline and Week 2||||units on a scale||Standard Error|Least Squares Mean
1383648|NCT01425528|Secondary|Pittsburgh Sleep Quality Index||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
1383649|NCT01425528|Secondary|Brief Symptom Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
1383650|NCT01425528|Secondary|Beck Depression Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
1383651|NCT01425528|Secondary|Behavior Rating Inventory of Executive Function (BRIEF) Adult Version||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
1383658|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4||From Baseline to Week 4|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
1383659|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2||From Baseline to Week 2|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
1383660|NCT01425463|Primary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12||From Baseline to Week 12|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
1383661|NCT01425359|Secondary|Patient's Global Impression of Change (PGIC) Scale Score|The PGIC was completed at the end of treatment/last visit.The PGIC scale measures the change in the participant's overall status since the beginning of the study on a scale ranging from 1 (no change or worse) to 7 (very much improved).|8 weeks|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
1383662|NCT01425359|Secondary|Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. Participants were asked to complete the survey at randomization (prior to receiving treatment), and at end of treatment visit (Week 8) or early study drug discontinuation or early termination visit. The survey asked participants for responses specific to the preceding 4 weeks prior to completing the survey.|Up to 8 weeks|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
1383663|NCT01425359|Secondary|Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency||6 weeks|Full Analysis Set|||percentage of weeks||Standard Error|Mean
1383664|NCT01425359|Secondary|Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency|For each participant, the percentage of the last 6 weeks on treatment during which the angina frequency was less than or equal to 50% of the baseline average weekly angina frequency was determined.|6 weeks|Participants in the Full Analysis Set with available data were analyzed.|||percentage of weeks||Standard Deviation|Mean
1383665|NCT01425359|Secondary|Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment|Average weekly frequency of sublingual nitroglycerin use was defined as the total number reported during the last 6 weeks of treatment divided by the duration corresponding to the last 6 weeks of treatment.|6 weeks|Full Analysis Set|||nitroglycerin uses per week||Standard Deviation|Mean
1383666|NCT01425359|Primary|Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment|"Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks.~For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject’s actual duration of treatment."|6 weeks|Full Analysis Set (FAS): randomized participants who received at least 1 dose of randomized study drug with at least 1 postbaseline primary efficacy measurement and did not have any major eligibility violations. Participants were included in the FAS if they did not discontinue study drug prior to Day 14.|||angina attacks per week||Standard Deviation|Mean
1383667|NCT01425307|Secondary|Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration|This secondary objective will compare standard to alternative therapy for hepatic iron overload.|Baseline and 24 months|Participants with available data|||mg FE per g dry weight liver||Standard Deviation|Mean
1383668|NCT01425307|Secondary|Number of Participants With Serious Adverse Events||24 Months|||||||
1383669|NCT01425307|Secondary|Number of Participants With Liver MRI Complications|This outcome will be recorded through questions asking whether there have been Liver MRI complications at baseline, middle, and end of treatment. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months|||||||
1383670|NCT01425307|Secondary|Number of Participants With Phlebotomy Complications|This outcome will be recorded on every interval visit form through questions asking whether there have been phlebotomy complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months|||||||
1383671|NCT01425307|Secondary|Number of Participants With Hydroxyurea Toxicities|This measure will be performed on a monthly basis throughout the trial by recording the CBC and retic count.|24 Months|||||||
1383672|NCT01425307|Secondary|Number of Participants With Transfusion Events|This outcome will be recorded on every interval visit form through questions asking whether there have been transfusion complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months|||||||
1383673|NCT01425307|Secondary|Growth and Development|This outcome will be measured by capturing height and weight monthly and conducting an annual pubertal assessment.|24 months|||||||
1383674|NCT01425307|Secondary|Neuropsychological Decline|This outcome will be measured using standardized neurocognitive tests at baseline and exit.|24 months|||||||
1383675|NCT01425307|Secondary|Functional Status|This outcome will be measured using Barthel Index testing at the beginning, middle, and end of the treatment period.|24 months|||||||
1383676|NCT01425307|Secondary|Effects on Quality of Life|Standard Quality of Life measure will be taken during specific time points as well as one newly developed Sickle Cell Disease-specific test.|24 months|||||||
1383677|NCT01425307|Secondary|Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin|This secondary objective will compare standard to alternative therapy for hepatic iron overload.|Baseline and 24 months||||ng per mL||Standard Deviation|Mean
1383678|NCT01425307|Secondary|Non-stroke Neurological Events|This secondary objective will compare standard to alternative treatment for the incidence of non-stroke neurological events. Data for this outcome will be collected through entry and exit neurological exams.|24 months|||||||
1383680|NCT01425307|Secondary|TCD Time-averaged Mean Velocity on the Non-index Side|This secondary endpoint for the TWiTCH trial will be maximum TCD time-averaged mean velocity on the non-index side. The non-index side is the side with the lower mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the secondary endpoint will be obtained at clinic visits during baseline and during the 24-month treatment period.|24 months|||||||
1383681|NCT01425307|Primary|Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side|The primary endpoint for the TWiTCH trial was the difference between the treatment groups of the maximum TCD TAMV on the index side, calculated from a mixed model. The index side is the side with the higher mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the TAMV on the index site were obtained at clinic visits during baseline and during the treatment period.|Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).|Intention-to-Treat|||cm/sec||95% Confidence Interval|Mean
1383682|NCT01425268|Secondary|Expansion Days|The median number of days taken to complete the expansion process.|12 months|All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)|||days|breasts|Full Range|Median
1383683|NCT01425268|Primary|Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event|The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.|12 months|Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.|||Breasts|Breasts||Count of Units
1383684|NCT01425229|Primary|Cmax|Cmax after the first dose of bosentan, at steady-state, during clarithromycin|after first dose, at steady-state, during clarithromycin||||ng/ml||95% Confidence Interval|Geometric Mean
1383685|NCT01425229|Primary|AUC|AUC of bosentan after first-dose, at steady-state and during clarithromycin therapy|0-infinity; dosing interval||||h*ng/ml||95% Confidence Interval|Geometric Mean
1383686|NCT01425203|Secondary|Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8|EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.|Treatment Week 8|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. The Crossover arm had zero participants at TW8 since the first opportunity for participants in the PBO + PR Control arm to roll over to the Crossover arm was at TW12.|||percentage of participants|||Number
1383687|NCT01425203|Secondary|Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)|SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|mITT population included all randomized participants who received ≥1 dose of experimental trial drug: BOC (for Experimental RGT BOC + PR arm) or Placebo (for PBO + PR Control arm). Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.|||percentage of participants|||Number
1383688|NCT01425203|Primary|Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)|SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.|||percentage of participants|||Number
1383689|NCT01425190|Primary|Final Dose of Boceprevir By Age Group||Day 1|This outcome measure could not be analyzed due to termination of the study prior to enrolling Cohorts 2 and 3.||||||
1383690|NCT01425190|Primary|Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir|The time at which the maximum plasma boceprevir concentration was observed.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hour||Full Range|Mean
1383691|NCT01425190|Primary|Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir|The maximum observed plasma concentration of boceprevir across sampling intervals was determined.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.|||ng/mL||Full Range|Mean
1383692|NCT01425190|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir|Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.|||ng hr/mL||Full Range|Mean
1383693|NCT01424943|Secondary|Parent Symptoms of Depression, Anxiety and Stress|DASS-21, brief screening measure of symptoms of depression, anxiety, and stress. Scores on each scale range from 0-21. Higher scores indicate more symptoms in each area.|baseline, 5 months||||scores on a scale||Standard Deviation|Mean
1383694|NCT01424943|Primary|KIPS|KIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.|Baseline, 5 months||||scores on a scale||Standard Deviation|Mean
1402510|NCT01243320|Primary|Change In Mean Corpuscular Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||pg||95% Confidence Interval|Mean
1383695|NCT01424943|Primary|Parenting Self-confidence|Toddler Care Questionnaire. Measures parent reported self-confidence in parenting a toddler. Parents rate their confidence in performing parenting tasks specific to toddlers. Higher scores indicate more confidence. Scores range from 37-185. The total sum score derived from adding the scores for the 37 items in this survey was used for this outcome measure.|Baseline, 5 months||||units on a scale||Standard Deviation|Mean
1383696|NCT01424943|Primary|Child Behavior|Child Behavior Checklist 1/5-5. A parent report measure of child behavioral problems. The score used for this outcome was the CBCL Total Score, which is a T-Score. T scores average 50 with a standard deviation of 10. Scores above 65 considered in the clinical range.|Baseline, 5 months||||T-score||Standard Deviation|Mean
1383697|NCT01424943|Primary|Parenting Style|Parenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.|Baseline, 5 months||||scores on a scale||Standard Deviation|Mean
1383698|NCT01424930|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.|||ng*h/mL||Standard Deviation|Geometric Mean
1383699|NCT01424930|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.|||hours||Full Range|Median
1383700|NCT01424930|Secondary|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.|||ng/mL||Standard Deviation|Geometric Mean
1383701|NCT01424930|Primary|Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication|AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.|Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1|Safety population: Participants who received at least 1 dose of study medication and contributed any safety data after the start of study treatment.|||Participants|||Number
1383702|NCT01424813|Other Pre-specified|Morning Peak Expiratory Flow Reading Reported on Patient Diary||Treatment days 1 through 85|||||||
1383703|NCT01424813|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).~Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:~Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Day 8, Day 85|Safety population|||participants|||Number
1383704|NCT01424813|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized. Two placebo participants were missing endpoint physical examinations.|||participants|||Number
1383705|NCT01424813|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 92|Safety analysis set|||participants|||Number
1383706|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
1383727|NCT01424644|Primary|Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo|The geometric mean concentrations (GMCs) of antibodies against pertussis antigens (PT, FHA and PRN), as measured by ELISA, following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1383707|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
1383708|NCT01424813|Other Pre-specified|Percent of Rescue Medication Free Days in the Patient Diary||Treatment days 1 through 85|||||||
1383709|NCT01424813|Other Pre-specified|Percent of Symptom Free Days on the Patient Diary||Treatment days 1 through 85|||||||
1383710|NCT01424813|Other Pre-specified|Duration of Response on Days 1, 8 and 85|Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes|Day 1, Day 8, Day 85|||||||
1383711|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85|||||||
1383712|NCT01424813|Other Pre-specified|Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85|||||||
1383713|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)||Day 1, Day 8, Day 85|||||||
1383714|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85||Day 85|||||||
1383715|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8||Day 8|||||||
1383716|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1||Day 1|||||||
1383717|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period||Day 1, Day 8, Day 85|||||||
1383718|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 85|||||||
1383719|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 8|||||||
1383720|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6||Day 1|||||||
1383721|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period||Day 1, Day 8, Day 85|||||||
1383722|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set|||L*hr||95% Confidence Interval|Mean
1383723|NCT01424813|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set which includes all participants in the intent-to-treat (ITT) population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.|||L*hr||Standard Error|Mean
1383724|NCT01424644|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|"The number of subjects reporting any unsolicited adverse reactions (AEs) when Tdap and HPV are concomitantly administered with MenACWY-CRM as compared to when Tdap and HPV vaccine are concomitantly administered with placebo.~Note: A total of 2 MenACWY-CRM+Tdap+HPV subjects reported AEs leading to premature withdrawal – one subject due to treatment emergent AE and another subject prior to study vaccination on day 1."|Throughout the study (Day 1 to Day 211).|Analysis was done on overall safety population - All subjects in the exposed population who provided postvaccination and post-baseline safety data.|||Subjects|||Number
1383725|NCT01424644|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine, Tdap and HPV vaccine as compared to concomitant administration of placebo with Tdap and HPV.|Day 1-7 after any vaccination.|Analysis was done on solicited safety Set - All subjects in the exposed population who provided solicited AEs.|||Subjects|||Number
1383726|NCT01424644|Secondary|Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.|The immunogenicity was assessed in terms of geometric mean hSBA titers of MenACWY when administered concomitantly with Tdap and HPV at 1 month after 1 dose of MenACWY vaccination.|1 month post MenACWY-CRM vaccination.|Analysis was done on the MenACWY per-protocol population - all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at baseline and one month postvaccination for at least one serogroup, and had no major protocol violation as defined prior to unblinding.|||Titers||95% Confidence Interval|Geometric Mean
1402511|NCT01243320|Primary|Change In Mean Corpuscular Volume Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 days||||fL||95% Confidence Interval|Mean
1383728|NCT01424644|Primary|Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo|The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population, i.e., all subjects who received all the relevant doses of vaccine correctly, and provided serology results at one month postvaccination, and had no major protocol violation as defined prior to unblinding.|||percentages of subjects||95% Confidence Interval|Number
1383729|NCT01424566|Secondary|Change From Randomization Baseline In NRS Constipation At Last Visit (Up To Day 36 Of The Double-blind Period)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was “no constipation”, and 10 was “constipation as bad as you can imagine.” Last visit refers to the last visit that a participant completed the assessment.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Randomization (Part B) Baseline NRS constipation score. The participant's Randomization (Part B) baseline constipation NRS value was the last evaluation (including unscheduled visits) in the single-blind treatment period (Part A) prior to the first dose of study drug in the double-blind treatment period (Part B). A negative value indicates improvement in condition from Randomization (Part B) Baseline."|Randomization Baseline, Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1383730|NCT01424566|Secondary|Change From Randomization Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment|"Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalence dose usages for each break-through opioid was calculated for the summary.~Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Randomization (Part B) Baseline daily maintenance opioid dose. The participant's Randomization (Part B) baseline daily break-through opioid dose value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in dose from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1383731|NCT01424566|Secondary|Change From Randomization Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End Of Treatment|"The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: “Have you used your maintenance dose painkiller today as prescribed?” If the participant answered “No” to the question, the daily opioid maintenance dose usage on that day was set to 0.~Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Randomization (Part B) Baseline daily maintenance opioid dose. The participant's Randomization (Part B) baseline daily maintenance opioid dose value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in dose from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1383732|NCT01424566|Secondary|Change From Randomization Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment|"The total daily opioid use (in morphine equivalence) was the sum of morphine equivalence of daily maintenance dose and break-through dose.~Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Randomization (Part B) Baseline daily total opioid use. The participant's Randomization (Part B) baseline daily total opioid use value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in use from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1383733|NCT01424566|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 36 Of The Double-blind Period)|The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers “extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied”. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period.|Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1383734|NCT01424566|Secondary|Physician Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period)|The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: “very much worse, much worse, slightly worse, no change, slightly improved, much improved, very much improved”. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period.|Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1402512|NCT01243320|Primary|Change In Hematocrit Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
1383735|NCT01424566|Secondary|Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period)|The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse”. The SGIC was assessed at Day 36 of the double-blind period or the day at which a participant’s last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period.|Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1383736|NCT01424566|Secondary|Change From Randomization Baseline In Mean Sleep Disruption NRS At End Of Treatment|Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated “did not disrupt sleep” and a score of 10 indicated “completely disrupted (unable to sleep at all).” Change in mean sleep disruption NRS was calculated as: End of Treatment sleep disruption NRS score - Randomization (Part B) Baseline sleep disruption NRS score. The participant's Randomization (Part B) baseline sleep disruption 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in sleep disruption score from Randomization (Part B) Baseline.|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1383737|NCT01424566|Secondary|Change From Randomization Baseline In Mean NRS Worst Pain At End Of Treatment|Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated “no pain” and a score of 10 indicated “pain as bad as you can imagine.” Change in mean NRS worst pain was calculated as: End of Treatment NRS worst pain score - Randomization (Part B) Baseline NRS worst pain score. The participant's Randomization (Part B) baseline worst pain 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in worst pain score from Randomization (Part B) Baseline.|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1383738|NCT01424566|Secondary|Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment|"Participants indicated level of pain in the last 24 hours on an 11-point NRS, where a score of 0 was “no pain” and 10 was “pain as bad as you can imagine”. Eligibility Baseline = mean score from the 3-day eligibility period. End of Treatment = mean score over last (up to) 4 days to the final pain score at End of Treatment or up until Day 36 of the double-blind period, whichever is earlier, or final score available (prematurely terminated).~Percentage improvement from baseline (Imp%) was calculated as:~Imp% = (Eligibility Baseline pain NRS mean - End of Treatment pain NRS mean)/Eligibility Baseline pain NRS mean * 100.~For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew unrelated to disease progression before end of Week 5, Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive."|Eligibility Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||percent improvement||Inter-Quartile Range|Median
1383739|NCT01424566|Primary|Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment|Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated “no pain” and a score of 10 indicated “pain as bad as you can imagine.” Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Randomization (Part B) Baseline NRS average pain score. The participant's Randomization (Part B) baseline pain 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in average pain score from Randomization (Part B) Baseline.|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1383740|NCT01424514|Secondary|Number of Participants With Vital Sign of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), HR and Body Temperature of PCI Abnormalities at Any Time During Treatment|The PCI values of vital signs were SBP: <85 and >160 millimetres of mercury (mmHg), DBP of <45 and >100 mmHg, HR of <40 and >110 beats per minute (bpm) and body temperature of <36 and >37.5oC.|Day 1 and Day 14 of each period|All Subjects Population.|||Participants|||Number
1383741|NCT01424514|Secondary|Number of Participants With Clinical Chemistry PCI Abnormalities of Creatinine, Blood Urea Nitrogen (BUN), Uric Acid, Cholesterol, Triglycerides, Lactate Dehydrogenase (LDH) and Liver Function Test at Any Time During Treatment|The PCI values of clinical chemistry parameters were creatinine: low- male is <75 micromoles per litre (mcmol/L); low– female is <65 mcmol/L; high- male >110 mcmol/L; high- female >95 mcmol/L, BUN: high is >1.5 x ULN millimole per litre (mmol/L), uric acid: low- male is <180 mcmol/L; low– female is <120 mcmol/L; high- male >480 mcmol/L; high- female >420 mcmol/L, cholesterol: low is <3.9 mmol/L; high is >6.5 mmol/L [if age <=40, if age >40- high is >6.55 mmol/L], triglycerides: low- <0.5 mmol/L; high- >2.0 mmol/L, LDH: >220 units per lire (U/L). For high alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase is >=2 x ULN U/L. Total bilirubin high is >=1.5 x ULN mcmol/L, gamma glutamyltransferase (GGT) high: male- >60 U/L; female > 40 U/L.|Day 14 of each period|All Subjects Population.|||Participants|||Number
1383994|NCT01421667|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)|Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Cmax of MMAE results.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1383742|NCT01424514|Secondary|Number of Participants With Clinical Chemistry PCI Abnormalities of Albumin, Calcium, Glucose, Potassium, Sodium and Total Carbon Dioxide (CO2) at Any Time During Treatment|The PCI values of albumin, calcium, glucose, potassium, sodium and total CO2 were obtained by multiplying a fixed factor to the site’s upper or lower limit normal ranges for each of the parameter. The factors were albumin (relative low): 0.86, calcium: 0.91 for relative low; 1.06 for relative high, glucose: 0.71 for relative low; 1.41 for relative high, potassium: 0.86 for relative low; 1.10 for relative high, sodium: 0.96 for relative low; 1.03 for relative high and total CO2: 0.86 for relative low; 1. 14 for relative high.|Day 14 of each period|All Subjects Population.|||Participants|||Number
1383743|NCT01424514|Secondary|Number of Participants With Haematology Abnormalities of Potential Clinical Importance (PCI) at Any Time During Treatment|The PCI values of hematology parameters were obtained by multiplying a fixed factor to the site’s upper or lower limit normal ranges for each of the parameter. The factors were white blood cell count (WBC): 0.67 for relative low; 1.82 for relative high, haemoglobin (Hb) relative high: male - 1.03; female - 1.13, haematocrit (relative high): male - 1.02; female - 1.17, platelets: 0.67 for relative low; 1.57 for relative high, neutrophils (relative low): 0.83, lymphocytes (relative low): 0.81.|Day 14 of each period|All Subjects Population.|||Participants|||Number
1383744|NCT01424514|Secondary|Number of Participants With Abnormal (Both Not Clinically Significant and Clinically Significant) Electrocardiogram (ECG) Findings|ECGs were obtained on Day 1 (pre-dose) and Day 14 (pre- dose) of each period. Single 12-lead ECGs was obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate (HR) and measures PR, QRS, QT, and QTc intervals. Participants with abnormal (not clinically significant), abnormal (clinically significant) and no result were presented.|Day 1 (pre-dose) and Day 14 (pre-dose)|All Subjects Population.|||Participants|||Number
1383745|NCT01424514|Secondary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event or Drug-related AE|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgement.|Start of study treatment (Day 1 of first period) up to follow up, for up to 28 days.|All Subjects Population.|||Participants|||Number
1383746|NCT01424514|Secondary|Pharmacokinetic Parameter of Time to Maximum Observed Plasma Concentration (Tmax) on Day 1 and 14|Blood samples for pharmacokinetic assessment were collected at pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period. Tmax was determined directly from the raw concentration-time data on Day 1 and Day 14 where, NQs were imputed to zero or missing and lower limit of quantification is 2.5 ng /mL. Analysis was done on the number of participants with non-missing observations (including imputed NC values)|Pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period.|Pharmacokinetic Population.|||h||Full Range|Median
1383747|NCT01424514|Secondary|Pharmacokinetic Parameter of Maximum Observed Plasma Concentration (Cmax) on Day 1 and 14|Blood samples for pharmacokinetic assessment were collected at pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period. The first occurrence of Cmax was determined directly from the raw concentration-time data on Day 1 and Day 14 where, NQs were imputed to zero or missing and lower limit of quantification was 2.5 nanogram per millilitre (ng /mL). Logarithmically transformed data is reported for Cmax. CVb (%) was calculated as, CVb (%) = SQRT (exp [SD2-1]) x 100, where SD is the standard deviation of the logarithmically transformed data. Analysis was done on the number of participants with non-missing observations (including imputed NC values).|Pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period.|Pharmacokinetic population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1383748|NCT01424514|Secondary|Pharmacokinetic Parameter of Area Under the Plasma Concentration-time Curves From Time Zero (Pre- Dose) to 3 h and 24 h (t) on Day 1 and Day 14 (AUC [0-3], AUC [0-t])|Blood samples for pharmacokinetic assessment were collected at pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period. The area under the plasma concentration-time curves from time zero (pre- dose) to 3 h, AUC (0-3) and the last quantifiable concentration, AUC (0-t) (24 h) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The AUC of non-calculable (NC) due to non-quantifiable concentration measured as below lower limit of quantification (NQ) values were imputed by 0.5 x lowest observed AUC (i.e., AUC [0-3]: 0.5 x 6.4; AUC[0-t]: 0.5 x 6.3). Coefficient of variation (CVb [%]) was calculated as, CVb (%) = SQRT (exp [SD2-1]) x 100, where SQRT is the square root, exp is the exponent and SD is the standard deviation of the logarithmically transformed data. Analysis was done on the number of participants with non-missing observations (including imputed NC values).|Pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period.|Analysis was done on Pharmacokinetic Population, defined as participants in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analysed. Imputed NC values were derived for AUC (0-3), on Day 1 for 3 participants and for AUC (0-t) on Day 1 for 2 participants.|||Nanogram × hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1383762|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383991|NCT01421719|Secondary|Number of Incontinence Episodes Per Day|Urinary incontinence 6 months after treatment (n=16). Data are included for participants who completed all diary entries and attended the Month 6 visit|6 months|Per protocol. Quantified from 3-day voiding diary at baseline and each clinical evaluation to 6 months. Mean change in daily incontinence made up analysis.|||leaks/day||Standard Deviation|Mean
1383749|NCT01424514|Secondary|Mean Total Ocular Symptom Score (TOSS; Red, Itchy and Tearing Eyes) Elicited by a 1 h CDA Challenge at 1 h Post-dose on Day 1, 1 and 24 h Post-dose on Day 14 to Compare the Effect of Intranasal SB-705498 12 mg Compared With Placebo|The assessment of TOSS was done based on a CDA challenge, for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h post dose on Day 1 and 1 h and 24 h post dose on Day 14 (Day 15). TOSS was calculated as the sum of the symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes. It was rated on a 4-point severity scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate and 3=severe (symptom hard to tolerate, interferes with daily activities/sleeping). TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. These values were used to derive the WM (s) of the CDA challenge value and the maximum score. WM is reported as LS mean.|Day 1 and 15 of each period (Day 14, 24 h post- dose was assessed on Day 15)|All Subjects Population. Only those participants available at the specified time points was analyzed.|||Scores on scale||Standard Error|Least Squares Mean
1383750|NCT01424514|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 on Day 14|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0=least severe to 6=extremely severe. Overall mean was calculated by summing all 28-item scores and dividing by total number of items in the questionnaire. RQLQ score ranges from 0-6 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline was defined as the value on Day 1 pre- dose. Change from baseline was calculated by subtracting baseline (Day 1 pre-dose) values from individual post-randomization values. Adjusted mean is reported as LS mean.|Baseline (Day 1 pre-dose) and Day 14 of each period|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Error|Least Squares Mean
1383751|NCT01424514|Secondary|Mean Change From Baseline to Day 14 of Acoustic Rhinometry (AR) Following Repeat Dosing of SB-705498 at 2 h and 25 h Post-dose|Overall AR score was obtained by adding minimal cross-sectional area (MCA) for right and left nostril. MCA1 was captured within the nose at a distance of 0 and 2.2 cm and MCA2 at 2.2 and 5.5 cm. MCA1 and MCA2 were captured simultaneously for each nostril, 3 measurements were obtained from each nostril which resulted in 12 data points. Absolute MCA for all regions in left or right nostril was calculated using the 3 acceptable measurements, calculating average of each of right and left MCA’s and also by selecting minimum value from these averages to obtain minimum MCA for left and right nostril. Baseline is defined as the value on Day 1 pre- dose. Change from baseline was calculated by subtracting the baseline (Day 1 pre-dose) values from individual post-randomization values done immediately following CDA challenge. In case of missing baseline or post randomization value, the change from baseline was set to be missing. Adjusted mean is reported as LS mean.|Baseline (Day 1 pre-dose), Day 14 and Day 15 of each period (Day 14, 25 h post dose on Day 14 was evaluated on Day 15)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Centimetre square (cm^2)||Standard Error|Least Squares Mean
1383752|NCT01424514|Secondary|Mean Sneezing Elicited by a 1 h CDA Challenge at 1 h Post-dose on Day 1, 1 and 24 h Post-dose on Day 14 to Compare the Effect of Intranasal SB-705498 12 mg With Placebo|The assessment of sneezing was done based on a CDA challenge, for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h post dose on Day 1 and 1 h and 24 h post dose on Day 14 (Day 15). Sneezing was scored on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The score ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. It was used to derive the WM CDA challenge value calculated over the time interval 0 to 60 m after start of CDA challenge and the maximum score. WM is reported as LS mean.|Day 1, Day 14 and Day 15 of each period (Day 14, 24 h post- dose was done on Day 15)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Error|Least Squares Mean
1383753|NCT01424514|Secondary|Mean Individual Component of TSS of Rhinorrhoea (Runny Nose), Nasal Congestion and Post-nasal Drip From Day 7 to Day 14 Following Repeat Doses of SB-705498|The individual component of TSS nasal symptoms of nasal congestion, rhinorrhoea (runny nose) and post nasal drip was scored on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The scores of the individual components of TSS ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. For Day 1 to 14 of each study period, participants were asked to keep a diary to record their symptoms whilst at home on a diary card provided by the clinical unit. Reflective rating represented the symptoms over the proceeding 12 h which was performed once daily in the PM. The PM reflective rating was done approximately 12 h after dosing, but before bedtime.|Day 7 to Day 14 of each period|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1383754|NCT01424514|Secondary|Mean TSS From Day 7 to Day 14 (Post-dose Prior to Challenge) Following Repeat Doses of SB-705498|TSS was calculated as the sum of the response for 3 components of nasal congestion, rhinorrhoea and post nasal drip. It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). TSS score ranges from 0-9 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. For Day 1 to 14 of each study period, participants were asked to keep a diary to record their symptoms whilst at home provided by the clinical unit. Reflective rating represented the symptoms over the proceeding 12 h which was performed once daily in the evening (PM). The PM reflective rating was done approximately 12 h after dosing, but before bedtime. If any of the individual components were missing then the TSS was set to be missing for that participant at that timepoint.|Day 7 to Day 14 of each period|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1383992|NCT01421667|Secondary|Baseline Soluble CD30 Expression|Serum concentration of soluble CD30 before first dose of brentuximab vedotin|Baseline|All patients who were treated with brentuximab vedotin monotherapy and had baseline sCD30 expression results.|||ng/mL||Full Range|Median
1383755|NCT01424514|Secondary|Mean Individual Component of TSS of Rhinorrhoea (Runny Nose), Nasal Congestion and Post-nasal Drip Elicited by a 1 h CDA Challenge, 1 h Post-dose on Day 1 to Compare the Effect of a Single Dose of 12 mg Intranasal SB-705498 With Placebo|The individual components of TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h and 24 h post dose on Day 1. The individual component of TSS nasal symptoms were nasal congestion, rhinorrhoea (runny nose), and post nasal drip It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The score ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. WM for TSS was calculated over the time interval 0 to 60 m after start of CDA challenge by calculating AUC of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as LS mean.|Day 1 of each period|All Subjects Population.|||Scores on scale||Standard Deviation|Mean
1383756|NCT01424514|Secondary|Mean Total Symptom Score (TSS) Elicited by a 1 Hour (h) CDA Challenge, 1 h Post-dose on Day 1 to Compare the Effect of a Single Dose of 12 mg Intranasal SB-705498 With Placebo|TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h and 24 h post dose on Day 1. TSS was calculated as the sum of the response for 3 components of nasal congestion, rhinorrhoea and post nasal drip. It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). TSS score ranges from 0-9 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. WM for TSS was calculated over the time interval 0 to 60 m after start of CDA challenge by calculating AUC of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as LS mean.|Day 1 of each period|All Subjects Population.|||Scores on scale||Standard Error|Least Squares Mean
1383757|NCT01424514|Primary|Mean Individual Component of TSS of Rhinorrhoea (Runny Nose), Nasal Congestion and Post-nasal Drip Elicited by a 1 h CDA Challenge, 1 h and 24 h on Day 14 to Compare the Effect of 14 Day Repeat Dosing of Intranasal SB-705498 12 mg With Placebo|The individual components of TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h and 24 h post dose on Day 14 (Day 15). The individual component of TSS nasal symptoms were nasal congestion, rhinorrhoea (runny nose), and post nasal drip It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The scores of the individual components of TSS ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. WM for TSS was calculated over the time interval 0 to 60 m after start of CDA challenge by calculating AUC of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as LS mean.|Day 14 to Day 15 of each period (Day 14, 24 h post- dose was done on Day 15)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1383758|NCT01424514|Primary|Mean Total Symptom Score (TSS) Elicited by a 1 Hour (h) Cold Dry Air (CDA) Challenge, 1 h and 24 h on Day 14 to Compare the Effect of 14 Day Repeat Dosing of Intranasal SB-705498 12 mg With Placebo|TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree Celsius (C), <15% relative humidity and 5+/-3 feet per second (ft/sec) air velocity, 1 h and 24 h post dose on Day 14 (Day 15). TSS was calculated as the sum of the response for 3 components of nasal congestion, rhinorrhoea and post nasal drip. It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). TSS score ranges from 0-9 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Weighted mean (WM) for TSS was calculated over the time interval 0 to 60 minute (m) after start of CDA challenge by calculating area under the curve (AUC) of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as least square (LS) mean.|Day 14 to Day 15 of each period (Day 14, 24 h post- dose was done on Day 15)|All Subjects population defined as all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Error|Least Squares Mean
1383759|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383760|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383761|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383763|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383764|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383765|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383766|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383767|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383768|NCT01424501|Secondary|Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1383769|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383770|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383771|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383772|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383773|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383774|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383775|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383776|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383777|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383778|NCT01424501|Secondary|Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1383779|NCT01424501|Secondary|Concentrations of Anti-M72 Antibodies|Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL).|Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
1383780|NCT01424501|Secondary|Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies|Cut-off values assessed were greater than or equal to (≥) 2.8, as measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the sera of subjects seronegative before vaccination.|Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules,receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||Participants|||Count of Participants
1383781|NCT01424501|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to day 210|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.|||Subjects|||Number
1383782|NCT01424501|Primary|Number of Subjects With Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29), after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.|||Subjects|||Number
1383809|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
1383783|NCT01424501|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, malaise, myalgia and temperature [body temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = body temperature above (>) 39.5°C. Related = event assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administered, for whom data were available and who had their symptoms sheets filled in.|||Participants|||Count of Participants
1383784|NCT01424501|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administered, for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
1383785|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IFN-gamma mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IFN-gamma mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
1383786|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of CCL2 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of CCL2 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
1383787|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-10 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-10 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
1383788|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-6 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-6 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
1383789|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-1beta mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-1beta mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
1383790|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of TNF-alpha mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of TNF-alpha mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Standard Deviation|Mean
1383791|NCT01424306|Secondary|Fasting Plasma Lipopolysaccharide-binding Protein (LBP)|Lipopolysaccharide-binding protein (LBP) will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. LBP is an acute phase protein secreted by the liver in response to endotoxin (lipopolysaccharide) exposure.|End (day 9) of each diet period.|All completed participants combined for protocol analysis|||ug/mL||Inter-Quartile Range|Median
1383792|NCT01424306|Secondary|Fasting Plasma Zonulin Concentrations|Zonulin concentrations will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. Plasma zonulin is a marker of intestinal permeability.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis|||ng/mL||Standard Deviation|Mean
1383810|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
1383793|NCT01424306|Secondary|Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test|Intestinal permeability will be assessed on day 9 of each diet period by administering a beverage containing 2 g of mannitol and 5 g of lactulose followed by collecting urine for 5 hours afterwards. Recovery of mannitol and lactulose in urine will be measured by gas chromatography, and will be indicative of the degree of intestinal permeability.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis|||ratio||Inter-Quartile Range|Median
1383794|NCT01424306|Secondary|Mean Daily Calorie Intake|Mean daily calorie intake will be assessed during each of the three 8-day diet periods. All foods will be provided to the subjects in excess of what they are estimated to require, and calorie intake will be assessed by subtracting returned foods from foods administered.|The mean daily calorie intake during each of the 8-day diet periods will be calculated.|All completed participants combined in per protocol analysis|||kcal/d||Standard Deviation|Mean
1383795|NCT01424306|Secondary|Fasting Plasma Adiponectin|The concentration of adiponectin in fasting plasma will be measured by enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis|||ng/mL||Standard Deviation|Mean
1383796|NCT01424306|Primary|Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period|The concentration of interleukin-6 in fasting plasma will be measured by high-sensitivity enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.|End (day 9) of each diet period|All completed participants combined in per protocol analysis|||pg/mL||Inter-Quartile Range|Median
1383797|NCT01424306|Primary|Fasting Plasma C-reactive Protein|The concentration of C-reactive protein in fasting plasma will be measured by high-sensitivity assay at the beginning (day 1) and end (day 9) of each 8-day dietary period.|Beginning (day 1) and end (day 9) of each diet period.|All completed participants combined in per protocol analysis|||mg/L||Inter-Quartile Range|Median
1383798|NCT01424228|Secondary|Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
1383799|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
1383800|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
1383801|NCT01424228|Secondary|Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks|Rescue medications include laxatives and enemas.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||days/week||Standard Deviation|Mean
1383802|NCT01424228|Secondary|Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||tablets/week||Standard Deviation|Mean
1383803|NCT01424228|Secondary|Time to First SCBM After Investigational Product Intake on Day 1 and Day 28||Day 1 and 28|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||hours||95% Confidence Interval|Median
1383804|NCT01424228|Secondary|Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
1383805|NCT01424228|Secondary|Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||percentage of SCBM||Standard Deviation|Mean
1383806|NCT01424228|Secondary|Change From Baseline in Straining Per SCBM at Up to 24 Weeks|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
1383807|NCT01424228|Secondary|Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||percentage of SCBM||Standard Deviation|Mean
1383808|NCT01424228|Secondary|Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
1383813|NCT01424228|Secondary|Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
1383814|NCT01424228|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. There were 21 subjects with a risk of potential unblinding due to an error in the randomization system who were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
1383815|NCT01424189|Secondary|Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5|"Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from never” to “always” (frequency) or “none” to “severe” (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score severe for the visual phenomenon."|Month 12 from second eye implantation|This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).|||percentage of participants|||Number
1383816|NCT01424189|Primary|Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5|The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn’t actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.|Month 12 from second eye implantation|This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). For participants with actual SSIs, performance testing outcomes conducted prior to the secondary intervention were carried forward to the final analysis.|||percentage of participants|||Number
1383817|NCT01424189|Primary|Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5|VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 12 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.|||logMAR||Standard Deviation|Mean
1383818|NCT01424189|Primary|Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5|Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 12 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.|||logMAR|eyes|Standard Error|Least Squares Mean
1383819|NCT01424072|Primary|Coping Strategy: Social Support Domain|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).|||units on a scale||Standard Deviation|Mean
1383820|NCT01424072|Primary|Coping Strategy: Distancing Domain|The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).|after 75 days||||units on a scale||Standard Deviation|Mean
1383845|NCT01423760|Secondary|Overall Survival (OS)|Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.|From randomization to death, assessed up to 3.6 years|Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)||||||
1384008|NCT01421641|Secondary|Intervention Pain|Pain with the intervention (injection or gel application). Subjects are asked to complete pain scale using a 100mm Visual Analog Scale (0mm=no pain and 100mm=worst pain of my life)|after application of randomized intervention||||mm||Standard Deviation|Mean
1383821|NCT01424072|Primary|Coping Strategy: Domain Social Support(After 60 Days)|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).|||units on a scale||Standard Deviation|Mean
1383822|NCT01424072|Secondary|Stress Scale|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).|||units on a scale||Standard Deviation|Mean
1383823|NCT01424033|Primary|Pulmonary Function Tests|Not recorded. Study terminated due to departure of PI.|Every 3 months|||||||
1383824|NCT01423916|Secondary|Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.|Changes in HR with values 25% decrease from Day −1 and HR < 50 bpm and 25% increase from Day −1 and HR > 100 bpm; PR interval of greater than or equal to 25% change from Day −1 and PR > 200 msec; QRS interval of Greater than or equal to 25% change from Day −1 and > 100 msec were noted on Day 11. Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate.|Day 11|Electrocardiograms were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.|||participants|||Number
1383825|NCT01423916|Secondary|Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.|Participants with incidence of ECG morphology abnormalities on Day 11 (participants who had abnormalities during Day 11 but not at Day -1) were noted. Types of abnormalities included appearance of abnormal U waves, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, and left bundle branch block. ECGs were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.|Day 11|Number of participants who took at least one dose of study drug post Day −1, and had evaluations of the ECG parameters at Baseline and Post Baseline.|||participants|||Number
1383826|NCT01423916|Secondary|Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.|The number of participants who were noted with new incidence of QT interval of > 500 msec on Day 11 and a 12-lead ECG was used.|Day 11|Assay sensitivity sample dataset demonstrated the ability of the trial that detected the effect of moxifloxacin on the QTcI that consisted from randomized participants in moxifloxacin and placebo arms, who had evaluable time-matched ECG assessments in both periods (Day -1/1 or Day 11/12) in placebo and moxifloxacin on Days -1, 1, 11, and 12.|||participants|||Number
1383827|NCT01423916|Secondary|Number of Participants With QTcI Interval > 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change of > 60 msec on Day 11 were presented here.|Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.|||participants|||Number
1383828|NCT01423916|Secondary|Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change between 30 to 60 msec were presented here.|Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.|||participants|||Number
1383829|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change from Baseline in summary of maximum QTcI on Day 11 minus maximum QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.|||msec||Standard Deviation|Mean
1383830|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change form Baseline in summary of maximun QTcI on Day 11 minus mean QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.|||msec||Standard Deviation|Mean
1383831|NCT01423916|Secondary|Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.|New onset (> 450, > 480, or > 500 msec) in QTc was defined as a participant who attained a QTc > 450, > 480, > 500 msec during Day 11 but not on Day −1. The number of participants were noted with time-matched change in mean QTcI change from Baseline for assay sensitivity of moxifloxacin treatment corrected for placebo. The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.|||participants|||Number
1383832|NCT01423916|Primary|Area Under the Plasma Concentration-time Curve During Dosing (AUCT).|Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations. For Moxifloxacin group, area under the plasma concentration-time curve was calculated to the last observable concentration.|||ng*h/mL||Standard Deviation|Mean
1383833|NCT01423916|Primary|Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.|||Hours||Full Range|Median
1383834|NCT01423916|Primary|Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|Pharmacokinetics (PK) analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.|||ng/mL||Standard Deviation|Mean
1383835|NCT01423916|Primary|Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).|Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.|AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication|Safety dataset of randomized participants received 1 dose of study medication after Day 1.|||participants|||Number
1383836|NCT01423916|Primary|Time-matched QTcI Change From Baseline (Day −1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.|Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)|The dataset quantitates effect of brexpiprazole on individual QTcI corrected for placebo of the completer population where participants received study medication from Day 1 to Day 11 (placebo at Day 1) had 1 Predose and Post-dose time-matched ECG assessments on Day 1 and Day 11. The first 5 time points for moxifloxacin arm only were 2-sided 98% CI.|||msec||90% Confidence Interval|Mean
1383837|NCT01423812|Secondary|Secondary Efficacy Endpoints|•Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24|week 24||||Participants|||Count of Participants
1383838|NCT01423812|Secondary|Medication Adherence Assessment|Characterize adherence to once-daily versus twice-daily darunavir/ritonavir containing regimens using the Modified Medication Adherence Self-Report Inventory (M-MASRI) scale|Within 48 weeks of randomization to study medications|||||||
1383839|NCT01423812|Secondary|Assessment of Virologic Failure|•Assess the development of viral resistance in subjects experiencing virological failure|Within 48 weeks of randomization to study medications|||||||
1383840|NCT01423812|Secondary|Immunologic Endpoints|•Absolute values and changes from baseline in CD4+ and CD8+ over time|48 weeks after randomization to study medications|||||||
1383841|NCT01423812|Secondary|Safety Assessment|•Compare the tolerability, safety, and change in lipid parameters(total cholesterol, LDL, HDL, triglycerides) of once-daily versus twice-daily darunavir/ritonavir containing regimens over 48 weeks|Within 48 weeks of randomization to study medications|||||||
1383842|NCT01423812|Secondary|Secondary Efficacy Endpoints|"Proportion of subjects with plasma HIV-1 RNA <50 c/mL and <400 c/mL at Week 24~Proportion of subjects with plasma HIV-1 RNA <400 c/mL at Week 48"|Within 48 weeks after randomization to study medication|||||||
1383843|NCT01423812|Primary|Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects|"Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 48 using a Missing, Switch, or Discontinuation = Failure (MSDF) algorithm as codified by the FDA's snapshot algorithm"|48 weeks after randomization to study medication||||participants|||Number
1383844|NCT01423773|Primary|Final Comfort|"Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable (My eyes are in pain. I cannot tolerate my lenses) and 100=Extremely Comfortable (My eyes feel GREAT, better than normal. I cannot feel my lenses)."|Day 2, Hour 10|All enrolled participants|||Units on a scale||Standard Deviation|Mean
1384009|NCT01421641|Primary|Tenaculum Pain|The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.|After tenaculum placement|4 subjects were excluded due to protocol violations|||mm||Standard Deviation|Mean
1383846|NCT01423760|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death|An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.|Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years|Only subjects treated with tecemotide were included in the safety analysis set.|||Subjects|||Number
1383847|NCT01423617|Secondary|Global Evaluation of Efficacy by Subjects|"The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of very good, good, moderate and poor."|12 weeks|||||||
1383848|NCT01423617|Secondary|Global Evaluation of Safety by Subjects|"The subjects evaluate independently the safety of the investigational product, using a scale with scores of “very good”, “good”, “moderate” and “poor."|12 weeks|||||||
1383849|NCT01423617|Secondary|Global Evaluation of Safety by Investigators|"The investigators evaluate independently the safety of the investigational product, using a scale with scores of “very good”, “good”, “moderate” and “poor."|12 weeks|||||||
1383850|NCT01423617|Secondary|Changes in Body Fat Free Mass (kg)||12 weeks|||||||
1383851|NCT01423617|Secondary|Subjects' Global Feeling of Satiety|Subject’s feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = ”no”; 1 = ”slightly”, 2 = ”moderate” and 3 = ”strong”.|12 weeks|||||||
1383852|NCT01423617|Secondary|Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)||12 weeks|||||||
1383853|NCT01423617|Secondary|Changes in Body Fat Content (%)||12 weeks|||||||
1383854|NCT01423617|Secondary|Changes in Waist-hip-ratio||12 weeks|||||||
1383855|NCT01423617|Secondary|Changes in Hip Circumference||12 weeks||||cm||Standard Deviation|Mean
1383856|NCT01423617|Secondary|Changes in Waist Circumference (cm)||12 weeks||||cm||Standard Deviation|Mean
1383857|NCT01423617|Secondary|Number of Subjects Who Lost at Least 3% of Baseline Body Weight||12 weeks||||participants|||Number
1383858|NCT01423617|Primary|Change in Mean Body Fat (kg)|Change in mean body fat at week 12 compared to baseline|12 weeks||||kg||Standard Deviation|Mean
1383859|NCT01423617|Primary|Change in Mean Body Weight (kg)|Change in mean body weight at week 12 compared to baseline.|12 weeks||||kg||Standard Deviation|Mean
1383860|NCT01423604|Secondary|Summary of Clinical Benefit|"A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:~Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status~Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation."|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||percentage of participants|||Number
1383861|NCT01423604|Secondary|Durable Response Rate|Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||percentage of participants|||Number
1383862|NCT01423604|Secondary|Objective Response Rate|Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Measured every 4 weeks for duration of study treatment (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||percentage of participants|||Number
1383863|NCT01423604|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||days||95% Confidence Interval|Median
1383864|NCT01423604|Primary|Overall Survival|Overall survival was measured as the length of time (in days) between the randomization date and the date of death.|Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||days||95% Confidence Interval|Median
1383865|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to week 12|Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1383993|NCT01421667|Secondary|Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)|Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Tmax of MMAE results.|||days||Full Range|Median
1383866|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score|The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to week 12|Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1383867|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score|The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to week 12|Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1383868|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in CGI-S Score|The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|baseline to week 12|Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
1383869|NCT01423253|Primary|Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)|12 Weeks|Safety Population|||percentage of subjects|||Number
1383870|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)|Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)|12 Weeks|Safety Population|||percentage of subjects|||Number
1383871|NCT01423253|Secondary|Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores|Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject’s level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to12 Weeks|Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).|||units on a scale||Standard Deviation|Mean
1383872|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects with treatment emergent adverse events (TEAEs)|12 Weeks|Safety population|||percentage of subjects|||Number
1383873|NCT01423162|Primary|Percent Iron Absorption|Percentage of iron available for absorption from fortified oat drink with and without added vitamin C|14 days after administration|Per protocol|||percentage of Iron absorbed||Standard Error|Mean
1383874|NCT01423084|Secondary|Number of Subjects Reporting SAEs and AE Leading to Withdrawal|Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject’s withdrawal from the study after any vaccination.|Throughout the study period.|Safety Set|||Number of subjects|||Number
1383875|NCT01423084|Secondary|Number of Subjects Reporting Unsolicited AEs|Number of subjects reporting any Unsolicited AEs after any vaccination.|From day 1 to day 7 after any vaccination.|Safety Set|||Number of subjects|||Number
1383876|NCT01423084|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.|From day 1 to day 7 after any vaccination|Safety Set|||Number of subjects|||Number
1383877|NCT01423084|Secondary|GMR of ELISA GMCs Against Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
1383878|NCT01423084|Primary|ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|One month after the second vaccination (day 61)|Per Protocol Set population|||IU/ml||95% Confidence Interval|Geometric Mean
1383879|NCT01423084|Secondary|ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset.|||IU/ml||95% Confidence Interval|Geometric Mean
1383880|NCT01423084|Secondary|Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.|The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Population, immunogenicity subset|||Percentage of subjects||95% Confidence Interval|Number
1383881|NCT01423084|Secondary|GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|"The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N.~meningitidis serogroup B reference strains at two weeks after last vaccination."|Two weeks after the second vaccination (day 45)|Per Protocol Set, Immunogenicity subset|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
1383882|NCT01423084|Secondary|hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset|||Titers||95% Confidence Interval|Geometric Mean
1383883|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
1396064|NCT01300286|Secondary|Packed Red Blood Cell Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||units||Inter-Quartile Range|Median
1383884|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.|The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
1383885|NCT01423084|Secondary|Percentage of Subjects in Each Lot With hSBA ≥ 1:5|The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group|One month after the second vaccination (day 61)|Per Protocol Set population|||Percentage of subjects||95% Confidence Interval|Number
1383886|NCT01423084|Primary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.|Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).|One month after the second vaccination (day 61)|Per Protocol Set population|||Titers||95% Confidence Interval|Geometric Mean
1383887|NCT01422915|Primary|Protoporphyrin Concentration in Blood|"erythrocyte protoporphyrin concentration, ug/dl~plasma protoporphyrin concentration, ug/dl"|Samples collected while on treatment (range 93-208 treatment days)||||ug/dl||Standard Deviation|Mean
1383888|NCT01422915|Primary|Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance|Minutes of sun tolerance|At 60 days of treatment|All of the original 4 subjects had bona fide erythropoietic protoporphyria (EPP). One subject was removed during Perdiod 1. The data from the same 3 subjects who completed periods 1 and 2 were analyzed for the study results. Data collected was not tractable for statistical analysis given the range of results|||minutes||Standard Deviation|Mean
1383889|NCT01422889|Secondary|Stent Thrombosis|Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|Annually, after the first year, through 2 years.|There were 57 subjects not evaluable for 2-year cardiac events (No follow-up ≥ 700 days and events-free within 730-day) leaving a total of 1054 subjects evaluated for ARC ST Definite/Probable.|||percentage of participants|||Number
1383890|NCT01422889|Primary|Cardiac Death or Myocardial Infarction (CD/MI)|Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|12 Months|There were 83 subjects not evaluable for 12-month cardiac events (No follow-up ≥ 335 days and events-free within 365-day) leaving a total of 1028 subjects evaluated for 12 month CD/MI.|||percentage of paricipants|||Number
1383891|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients|Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS-treatment naive patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.|||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
1383892|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Metformin Background Patients|Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS- Metformin background patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.|||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
1383893|NCT01422876|Secondary|Change From Baseline in Body Weight for Treatment Naive Patients|Change from baseline in body weight for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||kg change from baseline||Standard Error|Least Squares Mean
1383894|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised to and treated who had a baseline and at least 1 on treatment HbA1c value.|||% change from baseline||Standard Error|Least Squares Mean
1383895|NCT01422876|Secondary|Change From Baseline in Body Weight for Metformin Background Patients|Change from baseline in body weight for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||kg change from baseline||Standard Error|Least Squares Mean
1383896|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients|Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||mg/dL change from baseline||Standard Error|Least Squares Mean
1383897|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients|Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||mg/dL change from baseline||Standard Error|Least Squares Mean
1383898|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||% change from baseline||Standard Error|Least Squares Mean
1383899|NCT01422850|Primary|Blood Pressure, Pulse and Temperature|Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25||||participants|||Number
1383900|NCT01422850|Secondary|The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed.|No significant conclusion of efficacy is possible due to the study design with only one group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy, defined as stable disease or partial response, are possible. Trends towards possible treatment response were measured by monitoring PSA, a potential marker for prostate cancer disease progression; by other blood markers; and by Quality of life questionnaire (EORTC QLQ-C30) and WHO/ECOG (Eastern Cooperative Oncology Group). Control of any bone metastases were followed by hotspots and bone scan index measured by skeletal scintigraphy.|Within 12 weeks||||participants|||Number
1383901|NCT01422850|Primary|Adverse Events|"To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes).~AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not."|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25|No formal statistical analysis plan was considered for this study. Any subject that received one administration of ALECSAT and a 6 week follow-up period will be considered as having received ALECSAT and be included in the efficacy part of the report. All patients that received at least one injection of ALECSAT was assessed for safety.|||Events|||Number
1383902|NCT01422824|Secondary|Hemoglobin Levels||Baseline; Weeks 8, 16, 24, 48|Efficacy intent-to-treat population included all treated participants. Here, 'n' signifies the number of participants with available data for hemoglobin at specified visits.|||gram per liter||Standard Deviation|Mean
1383903|NCT01422824|Primary|Number of Participants With Adverse Events (AEs)|AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.|Up to 12 months|Safety population|||participants|||Number
1383904|NCT01422720|Secondary|Change From Baseline in Standardized Seizure Frequency|Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.|8-week Baseline Period and 26-week Treatment Period||||seizures/4 weeks||Standard Deviation|Mean
1383905|NCT01422720|Primary|Number of Subjects With Reported Adverse Events (AE)|"An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP.~TEAE assessment:~patients who died~patients who died due to Treatment-emergent adverse event (TEAE)~patients with at least one Serious Adverse Event (SAE)~patients with at least one Treatment-emergent Serious Adverse Event (TESAE)~patients prematurely terminated due to TEAE~patients with at least one TEAE~patients with at least one related TEAE~patients with at least one severe TEAE~patients without any TEAE"|throughout the study||||participants|||Number
1383906|NCT01422538|Secondary|Subject Satisfaction at 180 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.|||percentage of participants Satisfied|||Number
1383907|NCT01422538|Secondary|Subject Satisfaction at 90 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.|90 days post-treatment.|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied or Satisfied.|||percentage of participants Satisfied|||Number
1383908|NCT01422538|Other Pre-specified|Subject's Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only.|During Ulthera study treatment||||units on a scale||Full Range|Mean
1383909|NCT01422538|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment||||percentage of participants improved|||Number
1383910|NCT01422538|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment.||||percentage of participants improved|||Number
1383911|NCT01422538|Primary|Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.|Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.|90 days post-treatment||||percentage of participants improved|||Number
1383912|NCT01422434|Secondary|Change in mPASI From Baseline to Week 1|The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8|Baseline to Week 1||||percentage of change||Standard Deviation|Mean
1383913|NCT01422434|Secondary|Physician's Global Assessment of Psoriasis|"Subjects with ‘clear’ or ‘almost clear’ disease by physician’s global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.~The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Week 4||||participants|||Number
1383914|NCT01422434|Secondary|Change From Baseline in Target Lesion Assessment|"Percentage change in composite severity score of the target lesion from baseline to Week 4.~At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.~At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.~The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated."|Baseline to Week 4||||percentage of change||Standard Deviation|Mean
1383915|NCT01422434|Primary|Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)|"The primary response criterion was the percentage change in m-PASI from baseline to Week 4.~The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:~Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8."|Baseline to Week 4||||percentage of change||Standard Deviation|Mean
1383916|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Itching)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383917|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Dyspareunia)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383936|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Age)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383918|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Dryness)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383919|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Itching)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383920|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Dyspareunia)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383921|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Dryness)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383922|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Indications)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383923|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1385014|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin||Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin tmax data|||hours||Full Range|Median
1383924|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Indications)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383925|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383926|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383927|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383928|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383929|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1385047|NCT01407575|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|6 weeks||||units on a scale||Standard Deviation|Mean
1383930|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383931|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Menopause status)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383932|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383933|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383934|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Age)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383935|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
1383937|NCT01422408|Secondary|Number of Patients Experiencing Toxicities|Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.|Over 4 weeks|Toxicity and safety analyses will be conducted using the safety analysis set.|||Participants|||Count of Participants
1383938|NCT01422408|Secondary|Change in Total Vaginal Index Score.|"Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1383939|NCT01422408|Secondary|Change in Symptom Scores of Vaginal Itching|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1383940|NCT01422408|Primary|Change in Symptom Scores of Dyspareunia|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1383941|NCT01422408|Primary|Change in Symptom Scores of Vaginal Dryness|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
1383942|NCT01422382|Secondary|Number of Participants With at Least One Adverse Event.||24 Days||||Participants|||Number
1383943|NCT01422382|Primary|NK-104 AUC||15 Days|All subjects with measurable pharmacokinetic (PK) values|||ng * h/mL||Standard Deviation|Mean
1383944|NCT01422369|Secondary|Number of Participants With at Least One Adverse Event.||16 Days|All subjects who took at least one dose of study medication.|||Participants|||Number
1383945|NCT01422369|Primary|NK-104 AUC||16 Days|All subjects with measurable pharmacokinetic (PK) values.|||ng * h/mL||Standard Deviation|Mean
1383946|NCT01422356|Primary|HPV Prevalence|Prevalence of anal HPV of any type at baseline|Baseline|Number of men at baseline visit|||participants|||Number
1383947|NCT01422304|Other Pre-specified|Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration|This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased.|Up to 72 hours post study drug administration|APaT population|||participants|||Number
1383948|NCT01422304|Other Pre-specified|Postoperative Changes in Hgb Concentrations Using the Bleeding Index|The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 – Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline.|Baseline and Visit 3 (24-48 hours post study drug administration)|APaT population|||g/L||Standard Deviation|Mean
1383949|NCT01422304|Other Pre-specified|Total Transfusion Volume in Participants Who Required Postoperative Transfusion|Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to “normal” volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume.|From end of study drug administration through approximately 120 hours after study drug administration|Participants in APaT population who received a transfusion unit that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion)|||mL||Geometric Coefficient of Variation|Geometric Mean
1383970|NCT01422213|Secondary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
1383950|NCT01422304|Other Pre-specified|Number of Participants Requiring Any Postoperative Transfusion|The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion) was determined.|From end of study drug administration through approximately 120 hours after study drug administration|APaT population|||participants|||Number
1383951|NCT01422304|Other Pre-specified|Postoperative Drainage Volume Within 24 Hours After Study Drug Administration|The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.|Up to 24 hours post study drug administration|APaT population|||mL||Standard Deviation|Mean
1383952|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms.|Up to 14 days post study drug administration|APaT population|||participants|||Number
1383953|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis).|Up to 14 days post study drug administration|APaT population|||participants|||Number
1383954|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 14 days post study drug administration|APaT population|||participants|||Number
1383955|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 24 hours post study drug administration|APaT population|||participants|||Number
1383956|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration|"This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 14 days post study drug administration|APaT population|||participants|||Number
1383957|NCT01422304|Secondary|Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = [PT-Test/PT-Normal]^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline PT(INR) measurement within defined assessment window (10 or 60 minutes post study drug).|||percent change||Standard Deviation|Mean
1383958|NCT01422304|Secondary|Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline aPTT measurement within defined assessment window (10 or 60 minutes post study drug).|||percent change||Standard Deviation|Mean
1383959|NCT01422304|Primary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration|"Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant’s specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 24 hours post study drug administration|APaT population|||participants|||Number
1383960|NCT01422239|Secondary|Change in Smoking From Baseline to the Followup Assessment (Week 12)|Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study.|Week 0 (baseline), Week 12 (one month followup)|Participants who completed the week 8 appointment and provided the number of cigarettes smoked per day were included.|||CPD||Standard Deviation|Mean
1383961|NCT01422239|Secondary|Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|12 weeks|participants who did not complete the appointment were considered to be smoking|||participants|||Number
1383962|NCT01422239|Primary|Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|Up to 8 weeks|Participants who dropped out of the study were considered to be smoking.|||participants|||Number
1383963|NCT01422226|Primary|Ease of IUD Insertion (Use of Ancillary Measures)|The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.|During the IUD insertion procedure, up to 2 hours||||participants|||Number
1383964|NCT01422213|Secondary|Risk of Suicidality Using C-SSRS Scores|"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient.~For 2 patients in each treament group (6 in total) the CSSRS assessments are missing during study."|Up to 8 weeks|APTS|||participants|||Number
1383965|NCT01422213|Secondary|Change From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables."|Baseline and Week 8|FAS, LOCF|||z score||Standard Error|Least Squares Mean
1383966|NCT01422213|Secondary|Change From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables.~In the week 1 analysis the vortioxetine 10 and 20 mg groups were pooled because patients randomized to vortioxetine 20 mg received vortioxetine 10 mg in the first week of the study."|Baseline and Week 1|FAS, LOCF|||z score||Standard Error|Least Squares Mean
1383967|NCT01422213|Secondary|Proportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF|||percentage of participants|||Number
1383968|NCT01422213|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline||Baseline and Week 8|FAS, last observation carried forward (LOCF)|||percentage of participants|||Number
1383969|NCT01422213|Secondary|Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS|||units on a scale||Standard Error|Mean
1383986|NCT01422070|Secondary|Number of ICU Readmissions|Number of readmissions to intensive care unit during the same hospital course|Max 90 days after admission to the Study Unit||||readmissions|||Number
1383971|NCT01422213|Secondary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
1383972|NCT01422213|Secondary|Change From Baseline to Week 8 in the CRT (Attention)||Baseline and Week 8|FAS|||log10 (ms)||Standard Error|Mean
1383973|NCT01422213|Secondary|Change From Baseline to Week 8 in the SRT (Speed of Processing)|"Simple Reaction Time (SRT) is designed to assess psychomotor speed, and Choice Reaction Time (CRT) is designed to assess visual attention. Two computerised tests, part of the CogState battery were used to measure SRT and CRT in milliseconds:~The detection task measures SRT: the patient presses a yes button, whenever an onscreen playing card is turned over.~The identification task measures CRT: the patient presses a yes button whenever an onscreen playing card is turned over and is red, or a no button if the card is not red."|Baseline and Week 8|FAS|||log10 (ms)||Standard Error|Mean
1383974|NCT01422213|Secondary|Change From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)||Baseline and Week 8|FAS|||seconds||Standard Error|Mean
1383975|NCT01422213|Secondary|Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)|Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline and Week 8|FAS|||seconds||Standard Error|Mean
1383976|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT B (Executive Function)|TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline and Week 8|FAS|||seconds||Standard Error|Mean
1383977|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT A (Speed of Processing)|Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline and Week 8|FAS|||seconds||Standard Error|Mean
1383978|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Delayed Recall)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS|||number of words correctly recalled||Standard Error|Mean
1383979|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Acquisition)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS|||number of words correctly recalled||Standard Error|Mean
1383980|NCT01422213|Secondary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols)|"Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning). as a description of DSST."|Baseline and Week 8|FAS|||number of correct symbols||Standard Error|Mean
1383981|NCT01422213|Primary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores|"DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).~RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.~The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25."|Baseline and Week 8|FAS|||z score||Standard Error|Mean
1383982|NCT01422187|Secondary|Hemoglobin|Hemoglobin measure yearly|60 months||||mg/dL||Standard Error|Mean
1383983|NCT01422187|Secondary|Platelet Count|Platelet count measure annually|60 months||||platelets/mm^3||Standard Error|Mean
1383984|NCT01422187|Secondary|Liver Volume|Liver volume by MRI|60 months||||Milliliters||Standard Error|Mean
1383985|NCT01422187|Primary|Spleen Volume|Spleen volume measured by MRI|60 months||||Milliliters||Standard Error|Mean
1383995|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)|Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Ctrough of ADC results.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1383996|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)|End of infusion concentration of ADC following the first dose of brentuximab vedotin|1 day|All patients who were treated with brentuximab vedotin monotherapy and had Ceoi of ADC results.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1383997|NCT01421667|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy.|||participants|||Number
1383998|NCT01421667|Secondary|Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1383999|NCT01421667|Secondary|Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.|||months||Full Range|Median
1384000|NCT01421667|Secondary|Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved CR|||months||Full Range|Median
1384001|NCT01421667|Secondary|Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved a CR or PR.|||months||Full Range|Median
1384002|NCT01421667|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1384003|NCT01421667|Secondary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab|Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1384004|NCT01421667|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin plus rituximab.|||participants|||Number
1384005|NCT01421667|Primary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1384006|NCT01421654|Primary|Hours Used|The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.|30 days||||Total Hours Used||Standard Deviation|Mean
1384007|NCT01421641|Secondary|Tenaculum Placement Satisfaction|Satisfaction with overall tenaculum placement procedure. Subjects asked to answer their overall satisfaction with the pain control. Subjects asked to complete 100mm Visual Analog Scale (0mm=not at all satisfied to 100mm=very satisfied)|After placement of the tenaculum||||mm||Standard Deviation|Mean
1402513|NCT01243320|Primary|Change In Hemoglobin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||gm/dL||95% Confidence Interval|Mean
1384010|NCT01421589|Secondary|Change in Phosphocreatine Recovery|Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Obese men with reduced GH secretion were treated with rhGH for 12 weeks. All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties.|||mM/min||Standard Error|Mean
1384011|NCT01421589|Secondary|Change in Insulin Sensitivity|Change in fasting glucose from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||mg/dl||Standard Error|Mean
1384012|NCT01421589|Secondary|Change in Inflammatory Marker|Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||mg/l||Standard Error|Mean
1384013|NCT01421589|Secondary|Change in Body Composition|Change in waist circumference from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||cm||Standard Error|Mean
1384014|NCT01421589|Secondary|Change in Skeletal Muscle IGF-1 Gene Expression|Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Paired analyses (both Baseline and 12-weeks) from only 10 subjects are available for gene expression|||fold change||Standard Error|Mean
1384015|NCT01421589|Secondary|Change in Circulating IGF-1 Concentration|Change in circulating IGF-1 from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||ug/l||Standard Error|Mean
1384016|NCT01421589|Primary|Phosphocreatine Recovery|The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.|12-weeks|All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties. In addition, paired analyses (both Baseline and 12-weeks) from only 10 subjects were available for gene expression analyses. Therefore univariate regression analyses between IGF-1 mRNA and PCr recovery could only be performed in 10 subjects.|||correlation coefficient|||Number
1384017|NCT01421511|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.|||units on a scale||Standard Deviation|Mean
1384018|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the Day-7 Visit|Clinical improvement defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
1384019|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement defined as improvement in overall clinical status.|48-72 Hours|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
1384020|NCT01421511|Secondary|Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized participants receiving minimal study therapy, completed EOT and PTE Investigator's assessments, no concomitant systemic antibiotic therapy through PTE, and no confounding events or factors.|||participants|||Number
1384021|NCT01421511|Secondary|Investigator’s Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
1384022|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set|Responder: No increase in lesion surface area from baseline.|End of Therapy Day 11|All randomized participants receiving minimal study therapy, completed EOT assessment, no concomitant systemic antibiotic therapy and no confounding events or factors.|||participants|||Number
1384023|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit|Responder: No increase in lesion surface area from baseline.|Day 11|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
1384024|NCT01421511|Primary|The Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline.|48-72 hours|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
1384025|NCT01421498|Primary|Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84|The symptom functional scale is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the symptom functional scale questionnaire were graded on a scale of 0 (none of the time) to 4 (all of the time). The index consisted of 3 sub scales: symptoms (sensitivity to light, gritty sensation, pain, blurred vision, and poor vision [Items 1-5]), visual-related sub scale of the symptom functional scale (ability to read, drive at night, use a computer, watch television [Items 6–9]), and environmental triggers (windy conditions, low humidity, air conditioning [Items 10–12]). The symptom functional scale was scored on a scale of 0 to 100, with higher scores representing greater disability. Negative change from baseline indicates improvement.|Baseline (Day 0) to Day 84|ITT population with LOCF.|||units on a scale||Standard Deviation|Mean
1384044|NCT01421342|Secondary|Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale|Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976). A secondary outcome measure of response was defined as achieving a score of 2 (much improved) or 1 (very much improved).|During acute phase (up to 12 weeks)|Whole randomized cohort by intent-to-treat|||Participants|||Count of Participants
1385048|NCT01407575|Primary|Blood Pressure|Measure of systolic and diastolic blood pressure. 140/90 or lower is considered normal and indicates a better outcome.|6 weeks||||mm Hg||Standard Deviation|Mean
1384026|NCT01421498|Primary|Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the ‘worse eye’, defined as the eye with worse (higher) score at baseline.|Baseline (Day 0) to Day 84|Intent-to-Treat (ITT) population with Last Observation Carried Forward (LOCF) included all randomized participants who received at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
1384027|NCT01421472|Primary|Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)|Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.|At time of surgery, an expected average of 24-26 weeks|Subjects with evaluable resection.|||participants|||Number
1384028|NCT01421459|Other Pre-specified|Percentage of Participants With Treatment Emergent Antibody Response (TEAR)|TEAR is defined as an absolute increase of at least 1% in insulin antibody levels (measured in % binding) and at least 30% relative increase from Baseline for participants who are insulin antibody-positive at Baseline, or turning from insulin antibody-negative status at Baseline to antibody-positive during the course of the study following treatment with study drug.|4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).|||percentage of participants|||Number
1384029|NCT01421459|Other Pre-specified|Percentage of Participants With Detectable Insulin Antibody Levels||Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).|||percentage of participants|||Number
1384030|NCT01421459|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event.|||hypoglycemic events per 30 days||Standard Deviation|Mean
1384031|NCT01421459|Secondary|Incidence of Hypoglycemic Events|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline hypoglycemic event measure.|||hypoglycemic events in 24 weeks|||Number
1384032|NCT01421459|Secondary|Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).|||percentage of participants|||Number
1384033|NCT01421459|Secondary|Insulin Dose (Units)|Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline insulin dose measure; last observation carried forward (LOCF).|||units per day (U/day)||Standard Error|Least Squares Mean
1384034|NCT01421459|Secondary|Insulin Dose Per Body Weight (U/kg) Per Day|Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Insulin Dose per Body Weight measure; last observation carried forward (LOCF).|||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
1384045|NCT01421342|Secondary|Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C)|Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater|During acute phase (up to 12 weeks)||||Participants|||Count of Participants
1384035|NCT01421459|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1384036|NCT01421459|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on “Behavior” items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment."|4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ALBSS measure; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1384037|NCT01421459|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure; last observation carried forward (LOCF).|||kilogram (kg)||Standard Error|Least Squares Mean
1384038|NCT01421459|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure; last observation carried forward (LOCF).|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1384039|NCT01421459|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint [up to 24 weeks (wk)]|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure; last observation carried forward (LOCF).|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1384040|NCT01421459|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure.|||percentage of HbA1c||Standard Error|Least Squares Mean
1384041|NCT01421459|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.|Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline insulin antibody measure; last observation carried forward (LOCF).|||percentage of insulin antibody binding||Standard Error|Least Squares Mean
1384042|NCT01421459|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1384043|NCT01421355|Primary|Change in Brachial Artery Diameter|The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.|Day 0 and Day 4||||percentage of dilation||Standard Deviation|Mean
1384227|NCT01418365|Primary|Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set|||ng/ml||Standard Deviation|Mean
1384046|NCT01421342|Secondary|Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase|Relapse in symptoms of major depression defined as a QIDS-C16 => 11 among those achieving remission in the acute phase.|Within 36 weeks after randomization (initiation of treatment)|The Analysis Population is the cohort of participants who met the criteria for protocol remission during the Acute Phase (first 12 Weeks of follow-up)|||Participants|||Count of Participants
1384047|NCT01421342|Primary|Rate of Protocol Remission of Symptoms of Major Depressive Disorder|Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of <= 5 for two consecutive visits.|During acute phase (12 weeks)||||Participants|||Count of Participants
1384048|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between change from baseline in WPAI-AS and EQ-5D VAS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1384049|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between WPAI-AS and EQ-5D VAS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384050|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between change from baseline in WPAI-AS and EQ-5D total score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1384051|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between WPAI-AS and EQ-5D total score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384080|NCT01421147|Secondary|Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])|Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 insulin daily dose measurements. Last observation carried forward (LOCF) principle was used.|||units of insulin per day (U/day)||Standard Error|Least Squares Mean
1385049|NCT01407575|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity Theoretical Range 0-60 lower values represent better outcome|6 weeks||||units on a scale||Standard Deviation|Mean
1384052|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10(norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and MCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1384053|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline|WPAI-AS: 6-item questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). Sub-scores transformed to impairment percentages (range 0 to 100), higher numbers=greater impairment,less productivity. SF-36:standardized survey evaluating 8 aspects of functional health, well being (physical, social functioning; physical, emotional role limitations; bodily pain; general health; vitality; mental health). 8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50, standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and MCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384054|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity),activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100),higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and PCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1384055|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and mental component summary (MCS).Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and PCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384056|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between change from baseline in WPAI-AS and BAS-G score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1402514|NCT01243320|Primary|Change In Red Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||m/uL||95% Confidence Interval|Mean
1384057|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant’s health status. Correlation coefficient between WPAI-AS and BAS-G score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384058|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between change from baseline in WPAI-AS and BASMI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1384059|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant’s limitation of movement due to their AS. Correlation coefficient between WPAI-AS and BASMI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384060|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between change from baseline in WPAI-AS and BASFI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at visit 1 (baseline), started the treatment with etanercept and had at least one visit during follow-up. Here 'n' signifies those participants who were evaluable at specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1384061|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between WPAI-AS and BASFI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384442|NCT01415427|Primary|Change From Baseline in 6-minute Walk (6MW) Test - ITT|Efficacy was assessed by changes from baseline in 6-minute walk test|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not.|||meters||Standard Deviation|Mean
1384062|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between change from baseline in WPAI-AS and BASDAI score at Month 6 and 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
1384063|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between WPAI-AS and BASDAI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
1384064|NCT01421303|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24|WPAI: AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis (AS) for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Percentage of impairment||Standard Deviation|Mean
1384065|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 24.|||Percentage of impairment||Standard Deviation|Mean
1384066|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 18|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 18.|||Percentage of impairment||Standard Deviation|Mean
1384067|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 12|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 12.|||Percentage of impairment||Standard Deviation|Mean
1402515|NCT01243320|Primary|Change In White Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||k/uL||95% Confidence Interval|Mean
1384068|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 6|Follow-up analysis set (FAS) consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 6.|||Percentage of impairment||Standard Deviation|Mean
1384069|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire – Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline|Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given sub-scale items at baseline.|||Percentage of impairment||Standard Deviation|Mean
1384070|NCT01421277|Primary|Main Reason for Stopping Triptan Use||Up to 3 months|All screened participants who were fully eligible for the study.|||Number of partiicpants|||Number
1384071|NCT01421277|Primary|Number of Participants Continuing Triptan Therapy|Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.|Up to 3 monoths|All screened participants who were fully eligible for the study.|||Number of participants|||Number
1384072|NCT01421277|Primary|Number of Participants Using a Triptan for Migraine Attacks|Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.|Up to 3 months|All screened participants who were fully eligible for the study.|||Number of participants|||Number
1384073|NCT01421225|Secondary|Pre-lunch Blood Glucose Level|Blood glucose levels were documented at 12 pm just prior to being served lunch.|Participants will be followed for the duration of the 48 hour protocol||||mg/dL||Standard Error|Mean
1384074|NCT01421225|Secondary|Number of Interventions for Hypoglycemia|The number of interventions for hypoglycemia between 10 PM - 8 AM.|Participants will be followed for the duration of the 48 hour protocol||||Interventions|||Number
1384075|NCT01421225|Secondary|Post-prandial Glycemic Control|Peak post-prandial blood sugar between 8 AM and noon|Participants will be followed for the duration of the 48 hour protocol||||mg/dL||Standard Error|Mean
1384076|NCT01421225|Primary|Nocturnal Glycemic Control|Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.|Participants will be followed for the duration of the 48 hour protocol.||||Hours||Standard Error|Mean
1384077|NCT01421147|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.|||hypoglycemic events per 30 days||Standard Deviation|Mean
1384078|NCT01421147|Secondary|Incidence of Hypoglycemic Events|Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.|||events|||Number
1384079|NCT01421147|Secondary|Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).|||percentage of participants|||Number
1384081|NCT01421147|Secondary|Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])|Total daily insulin dose was adjusted for body weight [units of insulin/kilogram/day (U/kg/day)]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 daily insulin dose per body weight measurements. Last observation carried forward (LOCF) principle was used.|||U/kg/day||Standard Error|Least Squares Mean
1384082|NCT01421147|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen [(IR) 5 items: scores range 5-35], Lifestyle Flexibility [(LF) 3 items: scores range 3-21], Glycemic Control [(GC) 3 items: scores range 3-21], Hypoglycemic Control [(HC) 5 items: scores range 5-35], Insulin Delivery Device [(IDD) 6 items: scores range 6-42]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×[(7-raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ITSQ measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).|||units on a scale||Standard Error|Least Squares Mean
1384083|NCT01421147|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on Behavior items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country."|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ALBSS measurement. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).|||units on a scale||Standard Error|Least Squares Mean
1384084|NCT01421147|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline body weight measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).|||kilogram (kg)||Standard Error|Least Squares Mean
1384085|NCT01421147|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints (up to 24 weeks and up 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline fasting blood glucose measurement. Last observation carried forward (LOCF) principle was used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1384086|NCT01421147|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline SMBG measurement. Last observation carried forward (LOCF) principle was used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1384087|NCT01421147|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline HbA1c measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1384088|NCT01421147|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and were insulin antibody positive at baseline and had at least 1 post-baseline insulin antibody positive measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 and up to 52 weeks).|||percentage of insulin antibody binding||Standard Error|Least Squares Mean
1384089|NCT01421147|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant’s blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1384090|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)||Baseline to Week 6|Intent to treat population|||percentage of subjects|||Number
1384091|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).||Baseline to Week 6|Intent to treat population|||percentage of subjects|||Number
1384092|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score|The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to Week 6|Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment.|||units on a scale||Standard Error|Least Squares Mean
1384093|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient’s life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1–3 (mild), 4–6 (moderate), 7–9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to Week 6|Intent to treat population: If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|||units on a scale||Standard Error|Least Squares Mean
1384094|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to Week 6|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1384095|NCT01421134|Secondary|Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= ‘Normal, not at all ill’ to 7= ‘Among the most extremely ill patients’. A higher score is associated with greater illness severity.|Baseline to Week 6|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1384096|NCT01421134|Primary|Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores|The MADRS consists of 10 items, each rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|Baseline to Week 6|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1384097|NCT01420926|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|Duration of treatment|The 4 participants were not evaluated for adverse events were excluded from this analysis.|||participants|||Number
1384098|NCT01420926|Secondary|Progression-free Survival|Progression free survival (PFS) was defined as the time from study entry to progression or death. Progression free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to progression and/or death (up to 10 years)||||months||95% Confidence Interval|Median
1384099|NCT01420926|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) was defined as the time from CR to relapse or death. Relapse free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method. Relapse is defined as the reappearance of blood blasts or >= 5% marrow blasts after achieving a CR or CRi.|Time from study entry to relapse and/or death (up to 10 years)|Only participants who achieved a CR are included in this analysis.|||months||95% Confidence Interval|Median
1384100|NCT01420926|Secondary|Complete Remission Rate (CR and CRi)|Defined as the number of patients who achieve a CR or CRi divided by the total number of evaluable patients. A Complete remission (CR) requires: <5% marrow blast, > 200 nucleated cells, no blasts with auer rods, no extramedullary disease, ANC >1,000/mm^3 and platelets > 100,000/mm^3. A CR with incomplete blood count recovery (CRi) is defined as CR with exception of ANC < 1,000/mm^3 or platelets < 100,000/mm^3.|Duration of study up to 10 years||||percentage of participants||95% Confidence Interval|Number
1384101|NCT01420926|Primary|Overall Survival (OS) Time|Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to death assessed up to 10 years||||months||95% Confidence Interval|Median
1384118|NCT01420081|Secondary|Terminal Elimination Half Life (t½) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||hours||Standard Deviation|Mean
1384102|NCT01420848|Secondary|Students Anxiety Levels|The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.|90 days|It was analysed only the number of participants that ended the study.|||units on a scale||Standard Deviation|Mean
1384103|NCT01420848|Primary|Students Stress Levels|The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.|90 days|It was analysed only the subjects that ended the study.|||units on a scale||Standard Deviation|Mean
1384104|NCT01420289|Secondary|Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.|Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks|16 weeks||||Percent improvement in mean VAS pain sco||Standard Error|Mean
1384105|NCT01420289|Secondary|Perceived Improvement in Physical Function After 16 Weeks|"Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16.~The higher the score on the SF-36 questionnaire the better the QOL."|16 weeks||||Percent improvement in Sf-36 QOL score||Standard Error|Mean
1384106|NCT01420289|Secondary|Percent Improvement in Peak Walking Time|Percentage Improvement in the amount of time one can walk without pain|16 weeks||||Percentage Change||Standard Error|Mean
1384107|NCT01420289|Primary|Mean Percent Reduction in Wound Surface Area||baseline and 16 weeks||||Percent reduction in wound surface area||Standard Error|Mean
1384108|NCT01420146|Secondary|HER2 Extracellular Domain|evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality|within 60 min before tracer injection|||||||
1384109|NCT01420146|Secondary|Time Activity Curve|Time activity curve of normal organ and tumor lesions: pharmacokinetic|blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6|||||||
1384110|NCT01420146|Primary|Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings|A visual ‘patient-based’ classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG–PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2–PET/CT. Pts were grouped into 4 HER2–PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive’ & C+D=‘HER2-negative’. In the 20 pts: 4 pts were classified “A”, 5“B”, 1“C” & 10“D”. This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called ‘HER2-positive’ pt population. After dichotomization, 11(55%) pts were considered as HER2–PET/CT negative. Furthermore, HER2–PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).|4 years||||Participants|||Count of Participants
1384111|NCT01420081|Secondary|Summary of Treatment-related TEAEs|"Safety of subject in terms of number of participants with treatment related AEs.~Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm."|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of participants|||Number
1384112|NCT01420081|Secondary|Number of Treatment-related TEAEs|"Safety of subject in terms of number of participants with treatment related AEs.~Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm."|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of AEs|||Number
1384113|NCT01420081|Secondary|Summary of Treatment-emergent Adverse Events (TEAEs) - All Causalities|Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of participants|||Number
1384114|NCT01420081|Secondary|Number of Treatment-emergent Adverse Events (TEAEs) - All Causalities|Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of AEs|||Number
1384115|NCT01420081|Secondary|Steady State Volume of Distribution (Vss) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||Litres||Geometric Coefficient of Variation|Geometric Mean
1384116|NCT01420081|Secondary|Clearance (CL) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1384117|NCT01420081|Secondary|Time for Cmax (Tmax) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||hours||Full Range|Median
1384119|NCT01420081|Secondary|Maximum Plasma Concentration (Cmax) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1384120|NCT01420081|Secondary|Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
1384121|NCT01420081|Secondary|Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
1384122|NCT01420081|Secondary|Percentage of Participants in Each Treatment Arm With Gene and/or Protein Expression Biomarkers- PIK3CA Amplification, KRAS Mutation P/N, KRAS Mutation OBSV, PTEN Stroma Manual Score, PTEN Tumor Manual Score, KRAS SCC and Stathmin H/L,Tissue.|"Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, Phosphatase And Tensin Homolog (PTEN) protein levels, and PIK3CA gene amplification were to be assessed.~Stained tissues were evaluated by a board-certified pathologist who provided a manual pathology score (i.e., 0, 1+, 2+, or 3+) and, if appropriate, comments upon the staining of the specimen.~The directionality increases from 0 to 3+ with 0 being no staining for PTEN by IHC and 3+ being high staining intensity for PTEN."|Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.|||Percentage of participants|||Number
1384123|NCT01420081|Secondary|Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue|"Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, and PIK3CA gene amplification were to be assessed.~Each slide was imaged by whole slide scanning and patient samples were scored as follows:~Pathologist manual score (0, 1+, 2+, 3+) for overall staining intensity of tumor tissue.~Percentage of positive tumor cells staining at 0, 1+, 2+, and 3+.~H-score value (integer between 0 and 300) for tumor cell staining was calculated. The higher the stathmin staining, the higher the stathmin H-score."|Prior to Cycle 1 Day 1|Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.|||Score||Standard Deviation|Mean
1384124|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Triglycerides (mg/dL)||Standard Deviation|Mean
1384125|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Cholesterol (mg/dL)||Standard Deviation|Mean
1384126|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||HbA1c (mg/dL)||Standard Deviation|Mean
1384127|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Insulin (UIU/mL)||Standard Deviation|Mean
1384509|NCT01414166|Secondary|Percent Change From Baseline in HDL-C at Week 16|The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384128|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Glucose (mg/dL)||Standard Deviation|Mean
1384129|NCT01420081|Secondary|Overall Survival (OS) for PF-05212384|OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.|12 months|Survival analysis was not performed as the study was terminated early. No data are available because data were not collected. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||||||
1384130|NCT01420081|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384|Progression free survival is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the probability of remaining progression-free at 6 months (based on Kaplan-Meier estimates). Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|6 months|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Percentage of participants||95% Confidence Interval|Number
1384131|NCT01420081|Secondary|Progression Free Survival for PF-05212384|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Days||95% Confidence Interval|Median
1384132|NCT01420081|Secondary|Progression Free Survival for PF-04691502|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Time to Event (Days)|||Number
1384133|NCT01420081|Secondary|Percentage of Participants With Objective Response for PF-05212384|Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions.|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Percentage of participants||95% Confidence Interval|Number
1384134|NCT01420081|Secondary|Objective Response for PF-04691502|"Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions. The outcome data table below presents the number of participants with objective response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Participants response|||Number
1384152|NCT01419769|Primary|Safety - Freedom From Major Complications: Stent Migration/Dislodement|Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen|Through the duration of the 1-week post-stent removal study period|Per protocol population of subjects with stent successfully placed|||percentage of patients|||Number
1384153|NCT01419769|Primary|Safety - Freedom From Major Complications: Perforation|Subjects are free of surgery for access-site related perforation|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population|||percentage of patients|||Number
1384154|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Infection|Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Through the duration of the 1-week post-stent removal study period|Per protocol population|||percentage of patients|||Number
1384135|NCT01420081|Primary|Percentage of Participants With Clinical Benefit Response for PF-05212384|Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Percentage of participants||95% Confidence Interval|Number
1384136|NCT01420081|Primary|Clinical Benefit Response for PF-04691502|"Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Participants|||Number
1384137|NCT01419977|Primary|Change in Clinical Pain Scores|The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with “0” corresponding to no pain at one end and “10” indicating the worst pain at the other.|Baseline to day 3|9 subjects were discharged prior to obtaining day 3 VAS score.|||units on a scale||Standard Deviation|Mean
1384138|NCT01419977|Primary|Change in Thrombin Generation Assay - Endogenous Thrombin Potential|Patients will have thrombin generation assay samples drawn on Day 1 and 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.|||nM||Standard Deviation|Mean
1384139|NCT01419977|Primary|Change in Clinical Pain Scores|The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with “0” corresponding to no pain at one end and “10” indicating the worst pain at the other.|Baseline to day 1||||units on a scale||Standard Deviation|Mean
1384140|NCT01419977|Primary|Change in D-dimer|Patients will have D-dimer,for samples drawn on Day 1 and Day 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.|||ng/mL||Standard Deviation|Mean
1384141|NCT01419795|Secondary|Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse||Baseline, day 7 and 28 of course 1, and day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.||||||
1384142|NCT01419795|Secondary|Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses||Baseline, day 7 and 28 of course 1, and day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.||||||
1384143|NCT01419795|Secondary|Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.|||Number of adverse events|||Number
1384144|NCT01419795|Secondary|Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide||From baseline to day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.||||||
1384145|NCT01419795|Secondary|Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts||Assessed up to 18 months|No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.|||Participants|||Count of Participants
1384146|NCT01419795|Secondary|Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm.|||Participants|||Count of Participants
1384147|NCT01419795|Secondary|Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm.|||Participants|||Count of Participants
1384148|NCT01419795|Secondary|Rate of Response (CR, PR, or SD) and Time to Progression|Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.|Assessed up to 18 months|No participants enrolled in the second arm.|||progression free survival probability||95% Confidence Interval|Number
1384149|NCT01419795|Primary|Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1)|Estimated using the Kaplan-Meier method in all cohorts.|12 months|Primary objective could not be completed because there were no patients enrolled in the second experimental arm (lenalidomide). Additionally, having only three patients in one arm does not allow for a meaningful comparison to historic controls.|||survival probability||95% Confidence Interval|Number
1384150|NCT01419769|Primary|Safety - Freedom From Major Complications: SAE's|Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population|||percentage of patients|||Number
1384151|NCT01419769|Primary|Safety - Freedom From Major Complications: Tissue Injury|Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.|Through the duration of the 1-week post-stent removal study period|Per protocol population|||percentage of patients|||Number
1384157|NCT01419769|Secondary|Effectiveness: Stent Removability at 30 Days and/or 60 Days|AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.|Up to 60 days|Patients who had AXIOS stent successfully placed during index procedure.|||percentage of patients|||Number
1384158|NCT01419769|Secondary|Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days|Stent lumen patency at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol with successful stent placement.|||percentage of patients|||Number
1384159|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Bleeding|Subjects are free of access site-related bleeding requiring transfusion|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population|||percentage of patients|||Number
1384160|NCT01419639|Primary|Change in Tumor Size From Baseline||1 Year||||% of change in tumor size from baseline|Tumors|Full Range|Median
1384161|NCT01419639|Secondary|Audiologic Response|"Defined as improvement in speech discrimination score (SDS), defined as an improvement in the score above the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment. Audiologic worsening: decrease in SDS score below the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment.~Patients with vestibular schwannomas will receive baseline audiograms within 28 days before enrollments and subsequent audiograms at the time of each MRI."|1 Year||||participants|||Number
1384162|NCT01419639|Primary|Radiographic Response|To estimate the objective response rates to RAD001 in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas. Radiographic response for study purposes = greater than or equal to 15% reduction in tumor volume in any of the target tumors (partial response). Complete disappearance of any of the target tumors = complete response. MRI of the brain and spine will be performed every 3 months. If an objective response (15% reduction in tumor volume compared to baseline) is observed in any target tumor or stable disease, drug will be continued.|1 Year||||participants|Tumors||Number
1384163|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test~For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 6|The number of participants returning for the 6 week follow-up|||Meters (m)||Standard Deviation|Mean
1384164|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test~For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 3|The number of participants returning for the 3 week follow-up with complete data|||Meters (m)||Standard Deviation|Mean
1384165|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.|week 6|The number of participants returning for the second follow-up|||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
1384166|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.|week 3|The number of participants returning for the first follow-up with complete data.|||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
1384167|NCT01419314|Secondary|Function-Reach|"Forward reach test~For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 6|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.|||Centimeters (cm)||Standard Deviation|Mean
1384168|NCT01419314|Secondary|Function-Reach|"Forward reach test~For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 3|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.|||Centimeters (cm)||Standard Deviation|Mean
1384169|NCT01419314|Primary|Pain Scores|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 6|The total number of participants that completed the 6 week trial in each investigational group|||units on a scale 0-100 (0=no pain)||Standard Deviation|Mean
1384170|NCT01419314|Primary|Pain Scores at Week 3|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 3|The total number of participants returning for the first follow-up at week three with complete data.|||units on a scale 0-100 (0= no pain)||Standard Deviation|Mean
1385109|NCT01406795|Secondary|Adverse Events|Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.|up to two years 2 years||||Participants|||Count of Participants
1384171|NCT01419275|Primary|Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)|Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.|performed one time within 1 week prior to surgery|One participant did not undergo MRI and was not included in the analysis.|||percentage of regions|Cerebral regions|95% Confidence Interval|Number
1384172|NCT01419249|Primary|Height Velocity Standard Deviation Score (SDS) at Year 1|Height velocity SDS was calculated as height velocity minus reference mean height velocity divided by standard deviation of the reference population. Height velocity SDS reflects the height velocity relative to a reference population of the same age and gender. Height velocity SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.|||standard deviation score||Standard Deviation|Mean
1384173|NCT01419249|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 1|Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender. Change from baseline in height SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.|||standard deviation score||Standard Deviation|Mean
1384174|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in TS Girls Using Turner Syndrome Kabi-Pharmacia International Growth Study (TS KIGS) Predictive Model|TS KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum GH response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.||||||
1384175|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in IGHD Children Using Growth Hormone Deficiency Kabi-Pharmacia International Growth Study (GHD KIGS) Predictive Model|GHD KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum growth hormone (GH) response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.||||||
1384176|NCT01419249|Primary|Change From Baseline in Height at Year 1|Change from baseline in height at year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.|||centimeter||Standard Deviation|Mean
1384177|NCT01419236|Secondary|Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks|"The MSHQ-EjD-SF was a 4 item, self-reported questionnaire used for the assessment of EjD during the past month. The MSHQ-EjD-SF Bother/Satisfaction Score was based on Q4: If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this? Scores ranged from 0 (no problem with ejaculation), 1 (not at all bothered) to 5 (extremely bothered). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Bother/Satisfaction Score as fixed effects, and unstructured covariance structure for modeling correlation."|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1384178|NCT01419236|Secondary|Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks|IIEF: 15 item, self-reported questionnaire assessing overall erectile function and satisfaction during past month. Orgasmic Function Domain Score: sum of IIEF scores for Q9 and Q10. In Q9, participants (pts) identified how often they ejaculated when having sexual stimulation or intercourse. In Q10, pts identified how often they had a feeling of an orgasm with or without ejaculation when having sexual stimulation or intercourse. For each Q, scores ranged from 0 (no sexual stimulation or intercourse), 1 (almost never or never) to 5 (almost always or always). Total Orgasmic Function Domain Scores ranged from 0 to 10. LS mean of change from baseline calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Orgasmic Function Domain Score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1384186|NCT01419197|Secondary|6-month and 1-year Survival (Final Analysis)|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1384179|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Reported is orgasmic pleasure rated from 0 (no pleasure) to 10 (excellent). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline orgasmic pleasure as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1384180|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the change from baseline number of sexual attempts at 16 weeks. LS mean of change from baseline was calculated using an analysis of covariance (ANCOVA) including treatment group, region, baseline total testosterone level, baseline ED severity (normal, mild, moderate, severe) as fixed effects, and centered baseline as a covariate.|Baseline, up to 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline; Last observation carried forward (LOCF).|||sexual attempts||Standard Error|Least Squares Mean
1384181|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is delayed ejaculation rated from 0 (did not ejaculate) to 10 (optimal/best ejaculate time). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline delayed ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1384182|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived force of ejaculation rated from 0 (could not ejaculate) to 10 (strong ejaculation). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline perceived force of ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1384183|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived volume of ejaculate rated from 0 (no ejaculate) to 10 (high volume of ejaculate). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1384184|NCT01419236|Secondary|Change From Baseline in Ejaculate Volume at 16 Weeks|The change from baseline in ejaculate volume was determined by actual measurement of semen volume in milliliters (mL). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||mL||Standard Error|Least Squares Mean
1384185|NCT01419236|Primary|Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks|MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed‐effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level [≥200 nanograms per deciliter (ng/dL) versus (vs.) <200 ng/dL], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1384187|NCT01419197|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1384188|NCT01419197|Secondary|Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle|The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1384189|NCT01419197|Secondary|Time to Pain Symptom Progression|Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1384190|NCT01419197|Secondary|6-month and 1-year Survival|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1384191|NCT01419197|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with an objective response were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1384192|NCT01419197|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
1384193|NCT01419197|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1384194|NCT01419197|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
1384195|NCT01419184|Secondary|cSSSI-related Medical Resource Utilization and Costs|Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented.|Baseline (Day 0) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.|||dollars (United States)||Standard Deviation|Mean
1384206|NCT01419171|Secondary|12 Month Cardiac Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384207|NCT01419171|Secondary|12 Month All Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384196|NCT01419184|Secondary|30-day cSSSI-related Hospital Readmission Rates|Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented.|End of Hospital Stay (up to Day 14) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.|||participants|||Number
1384197|NCT01419184|Secondary|Participant Global Impression of Improvement (PGI-I) at Hospital Discharge|PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement.|End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable PGI-I data at hospital discharge.|||units on a scale||Standard Deviation|Mean
1384198|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)|Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility.|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable EQ-5D data at baseline and at hospital discharge.|||units on a scale||Standard Deviation|Mean
1384199|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)|Pain was measured as the amount of pain experienced “right now” by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain.|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable BPI-SF data at baseline and at hospital discharge.|||units on a scale||Standard Deviation|Mean
1384200|NCT01419184|Primary|Infection-Related Hospital Length of Stay|Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.|Baseline (Day 0) through the End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. As the end of the IRLOS depended upon the participant’s course of treatment, no static set of items were answered to determine if a participant had complete data.|||Hours||Standard Deviation|Mean
1384201|NCT01419171|Secondary|Clinical Procedural Success Rate|Clinical Procedural Success: lesion diameter stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. Summarized per patient.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of patients||95% Confidence Interval|Number
1384202|NCT01419171|Secondary|Periprocedural Endpoints: Technical Success Rate|Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of patients|Participants|95% Confidence Interval|Number
1384203|NCT01419171|Secondary|12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384204|NCT01419171|Secondary|12 Month All Death/MI/TVR Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384205|NCT01419171|Secondary|12 Month All Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384208|NCT01419171|Secondary|12 Month Non-cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384209|NCT01419171|Secondary|12 Month Cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384210|NCT01419171|Secondary|12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384211|NCT01419171|Secondary|12 Month Target Vessel Failure (TVF) Rate|Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384212|NCT01419171|Secondary|12 Month Target Vessel Revascularization (TVR) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384213|NCT01419171|Secondary|12 Month Target Lesion Revascularization (TLR) Rate|Any ischemia-driven repeat percutaneous coronary intervention (PCI), to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
1384214|NCT01419171|Primary|9-month Target Lesion Failure (TLF) Rate|The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|Nine Month|N=323 (5 patients were not evaluable for the endpoint: Follow-up < 240 days and event-free)|||percentage of participants||95% Confidence Interval|Number
1384215|NCT01419028|Secondary|Invasive Ventilator-free Survival Time|Invasive ventilator-free survival is defined as the time during which the patient is alive and not invasively ventilated. For the purpose of this study, invasive ventilation is defined as mechanical ventilation via intubation of trachaeostomy.|Retrospective data collected on or before the date of abstraction.||||days||95% Confidence Interval|Median
1384216|NCT01419028|Primary|Survival|Overall survival is defined as the time from birth to time of death.|Retrospective data collected on or before the data of abstraction.||||days||95% Confidence Interval|Median
1384217|NCT01418937|Primary|Number of Pregnant Subjects Reporting Pregnancy Outcomes|The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.|Throughout the study period (from Month 0 up to Month 12)|The analysis was performed on the number of pregnant subjects participating in the study.|||Subjects|||Number
1384218|NCT01418937|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered|||Subjects|||Number
1384219|NCT01418937|Primary|Number of Subjects With Potential Immune-mediated Disease (pIMDs)||Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered|||Subjects|||Number
1384220|NCT01418937|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered|||Subjects|||Number
1384221|NCT01418703|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR||||mg/dL||Standard Deviation|Mean
1384222|NCT01418703|Secondary|Percent Time Spent in Near Normoglycemia|Comparison of time spent in near normoglycemia (3.9 to 10 mmol/mL) in open-loop vs closed-loop sCTR and eCTR.|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR||||percentage of time||Standard Deviation|Mean
1384223|NCT01418703|Primary|Hypoglycemic Events|Number of hypoglycemic events below 70 mg/dL per patient per day|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR||||events/admission per patient||Standard Deviation|Mean
1384228|NCT01418365|Primary|Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consists of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ng*h/ml||Standard Deviation|Mean
1384229|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
1384230|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
1384231|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
1384232|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
1384233|NCT01418209|Primary|Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 8 study assessment to produce a mean daily frequency for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||number of hot flashes per day||95% Confidence Interval|Mean
1384234|NCT01418209|Secondary|Severity of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS severity for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
1384235|NCT01418209|Secondary|Severity of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS severity for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
1384236|NCT01418209|Primary|Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 4 study assessment to produce a mean daily frequency for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||number of hot flashes per day||95% Confidence Interval|Mean
1384237|NCT01418001|Secondary|Pathologic Response|will be assessed by both MRI and by pathologic review after surgery. An estimate of each response rate and the 95% CI will be provided|2 years|No data is available because data was not collected due to lack of accrual.||||||
1384238|NCT01418001|Primary|Overall Objective Response|"Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 6 weeks up to 2 years||||participants|||Number
1384252|NCT01417936|Secondary|Duration of Overall Response|Duration of overall response was defined as the time from the first time point where measurement criteria are met for CR or PR until first date of recurrence or PD was objectively documented according to RECIST Version 1.1. Duration of overall response was censored at date of last imaging data of measured lesions if no confirmation of recurrence or PD was available.|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|Duration of overall response could not be calculated as no subject showed CR or PR.||||||
1384239|NCT01417936|Secondary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||Subjects|||Number
1384240|NCT01417936|Secondary|Volume of Distribution (Vz)|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||milliliter/kilogram||Standard Deviation|Mean
1384241|NCT01417936|Secondary|Time to Reach Minimum Serum Concentration (Tmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||hour||Standard Deviation|Mean
1384242|NCT01417936|Secondary|Time to Reach Maximum Serum Concentration (Tmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||hour||Standard Deviation|Mean
1384243|NCT01417936|Secondary|Terminal Half Life (T1/2)|The apparent terminal half-life was defined as the time required for the serum concentration of Sym004 to decrease 50% in the final stage of its elimination.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||hour||Standard Deviation|Mean
1384244|NCT01417936|Secondary|Clearance (CL)|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||milliliter/hour/kilogram||Standard Deviation|Mean
1384245|NCT01417936|Secondary|Minimum Serum Concentration (Cmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram/milliliter||Standard Deviation|Mean
1384246|NCT01417936|Secondary|Maximum Serum Concentration (Cmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram/milliliter||Standard Deviation|Mean
1384247|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf])|The AUC (0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram-hour/milliliter||Standard Deviation|Mean
1384248|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168])|The AUC (0-168h) was estimated by determining the total area under the curve of the concentration versus time curve.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram-hour/milliliter||Standard Deviation|Mean
1384249|NCT01417936|Secondary|Number of Subjects With Detectable Biomarkers at Any Visit|The biomarkers human papilloma virus (HPV), mutated epidermal growth factor receptor (EGFRvIII), c-MET and human epidermal growth factor receptor (HER) 2, HER3 were analyzed only in tumor cells while EGFR, phosphorylated epidermal growth factor receptor (pEGFR), and Ki-67 were analyzed both in tumor and skin biopsy cells.|Weeks 0 and 4; and 4 weeks after last dose|"The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. n signifies subjects evaluable for specified biomarker type."|||Subjects|||Number
1384250|NCT01417936|Secondary|Overall Survival Time|Overall survival time was defined as the time from first infusion of Sym004 until date of death. Subjects who withdraw the consent or lost to follow-up were censored.|Time from first infusion of Sym004 until death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||days||95% Confidence Interval|Median
1384251|NCT01417936|Secondary|Time to Progression (TTP)|The TTP was defined as the time from first infusion of Sym004 until disease progression according to RECIST Version 1.1 criteria. Disease progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The subjects who died without prior assessment of PD were censored for TTP.|Time from first infusion of Sym04 until disease progression, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||days||95% Confidence Interval|Median
1384301|NCT01416610|Primary|Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)|SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).|24 weeks after completing treatment, within 3 years, 6 months||||percentage of participants||95% Confidence Interval|Number
1384253|NCT01417936|Secondary|Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate)|"Best objective tumor response was defined as the occurrence of complete response (CR), partial response (PR), stable disease (SD), or PD according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.~Objective response was defined as the occurrence of CR or PR according to RECIST Version 1.1. Disease control was defined as the occurrence of CR, PR or SD according to RECIST Version 1.1.~CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm; PR: At least a 30% decrease in the sum of diameters of all - lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial."|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||Percentage of subjects||95% Confidence Interval|Number
1384254|NCT01417936|Primary|Progression Free Survival (PFS) Time|The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates.|Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||days||95% Confidence Interval|Median
1384255|NCT01417481|Secondary|Changes in Other Spirometric Variables|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks||||Percentage of baseline||Standard Error|Mean
1384256|NCT01417481|Secondary|Changes in FEV1, FEF25, and FEFmax|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks||||Percentage of baseline||Standard Error|Mean
1384257|NCT01417481|Secondary|Changes in Pulse Oximetry, FEV1/FVC, and FEF50.|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks||||Percentage of baseline||Standard Error|Mean
1384258|NCT01417481|Secondary|Changes in Score for Sputum Production, Dyspnea and Global Symptoms|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).~In the symptoms questionnaire, each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks||||Percentage of baseline||Standard Error|Mean
1384259|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks||||log (percent change)||Standard Error|Mean
1384260|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (IL-6)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children did not expectorate at some visits. Thus, only a non-paired population of 9 children under glycine and 11 under placebo could be analyzed.|||log (percent change)||Standard Error|Mean
1384261|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.|||log (percent change)||Standard Error|Mean
1384262|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (Other Than IL-6 and G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children at some visits could not give an appropriate sputum sample. Thus, only a non-paired population of 9 (glycine group) and 11 (placebo group) children could be analyzed.|||log (percent change)||Standard Error|Mean
1384263|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (Other Than TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.|||log (percent change)||Standard Error|Mean
1384302|NCT01416584|Other Pre-specified|Entered Methadone Treatment|Did the participant enter methadone treatment at any point in the 6-month treatment period?|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
1384264|NCT01417481|Secondary|Changes in Clinical Data Scores (Other Than Sputum Production, Dyspnea and Global Symptoms)|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).~Each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks||||Percentage of baseline||Standard Error|Mean
1384265|NCT01417455|Primary|Osteoclast Activity Ex-vivo|Total area resorbed by osteoclasts as percentage of total area analyzed|at baseline and at 6 months||||percentage of resorbed area||Inter-Quartile Range|Median
1384266|NCT01417455|Primary|Osteoclast Differentiation Ex-vivo|Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.|at baseline and at 6 months||||OC/mm2||Inter-Quartile Range|Median
1384267|NCT01417377|Secondary|Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)||Up to 6 months|The number of doses were not collected because the participants never achieved Hb level of 11 to 12 g/dL.||||||
1384268|NCT01417377|Secondary|Number of Dose Adjustments Required to Maintain Hb Levels||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.||||||
1384269|NCT01417377|Secondary|Time to Achieve Hb Level to 11-12 g/dL||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.||||||
1384270|NCT01417377|Primary|Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study||Month 4 up to Month 6|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.||||||
1384271|NCT01417195|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics.|Day 1 up to Day 20|Safety population|||participants|||Number
1384272|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 6|"Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 6|Intent to treat population for the combination treatment arm only|||participants|||Number
1384273|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 1|"Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 1|Intent to treat population for the combination treatment arm only|||participants|||Number
1384274|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6|Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 6|Intent to treat population for the combination treatment arm only|||participants|||Number
1384275|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1|Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 1|Intent to treat population for the combination treatment arm only|||participants|||Number
1384276|NCT01417195|Primary|Fertilization Rate|The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100.|approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))|Intent to treat population|||percentage of oocytes retrieved||Standard Deviation|Mean
1384277|NCT01417156|Secondary|Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.|The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.|Week 234|TS|||percentage of participants|||Number
1384278|NCT01417156|Secondary|Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.|The risk (incidence rate calculated as number of patients with at least 1 exacerbation, divided by the total time at risk ×100) of acute exacerbation of IPF.|First drug administration until end of treatment, up to 5 years|TS|||patients per 100 patient-year||95% Confidence Interval|Number
1402516|NCT01243320|Primary|Change In Calcium Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
1384279|NCT01417156|Secondary|Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|"Adjusted annual rate of decline in Hb corrected DLCO. The means presents actually adjusted rate based on random coefficient regression with fixed effects for gender, age, height & random effect of patient specific intercept & time. Within-patient errors are modelled by Unstructured variance-covariance matrix.Inter-individual variability is modelled by a variance-Components variance−covariance matrix.~mmHg: millimeters of mercury"|Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years|OC-TS|||mL/Minute(min)/mmHg per year||Standard Error|Mean
1384280|NCT01417156|Secondary|Annual Rate of Decline in Forced Vital Capacity (FVC).|"The adjusted annual rate of decline in Forced Vital Capacity (FVC). The means presents actually the adjusted rate based on a random coefficient regression with fixed effects for gender, age, height and random effect of patient specific intercept and time. Within−patient errors are modelled by an Unstructured variance−covariance matrix. Inter−individual variability is modelled by a Variance−Components variance−covariance matrix.~The result for Annual rate of decline (ROD) in FVC should be interpreted with caution and along with descriptive statistics, because inferences used for this analysis might not be valid as suggested by skewed distribution of the data."|Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years|TS-OC Observed Case (OC): This method was used for the replacement of missing values.|||(mililitre (mL)/year)||Standard Error|Least Squares Mean
1384281|NCT01417156|Primary|Incidence of Overall Adverse Events|Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.|First drug administration until end of treatment, up to 5 years|Treated set (TS)|||participants|||Number
1384282|NCT01417104|Other Pre-specified|Change From Baseline in Resting Diastolic Blood Pressure|Difference between end of treatment and baseline in resting diastolic blood pressure|baseline to end of treatment ( up to 36 weeks)|Intent to treat analysis including only participants who had at least one post-baseline assesment|||mm Hg||95% Confidence Interval|Mean
1384283|NCT01417104|Secondary|Change in the Percentage Wall Volume (PWV) Between Baseline and End of Treatment|Using an approach similar to intravascular atheroma volume calculations, percentage wall volume (PWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated. and a difference between baseline and end of treatment was calculated.|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI not analyzable, 23 final MRI not obtained due to trial termination|||Percentage of the Outer Wall Volume||Standard Deviation|Mean
1384284|NCT01417104|Primary|Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment|"All patients underwent imaging using a 3T, MRI system. The MRI sequence method used for wall depiction was a 3D, fat suppressed, dark blood, turbo spin echo sequence with variable flip angles (SPACE). Following co-registration of pre and post treatment MR images, and generation of MPR sections, images were magnified, contrast adjusted and patient/exam identifier information was removed and replaced by pre-assigned code to blind images for measurements.~An experienced observer performed manual measurements of lumen and lumen plus wall areas by delineating the inner border and the outer border of the vessel wall in each cross-section image of the aorta. Using an approach similar to intravascular atheroma volume calculations, normalized total aortic wall volume (TWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated."|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI data sets were not analyzable ( low quality images), and 23 post-treatment MRI not obtained ( <17 weeks on drug when trial terminated owing to ALTITUDE results)|||mm3||Standard Deviation|Mean
1384285|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration|"Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last).~The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours."|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.~One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."|||hour*nanogram/milliliter (h*ng/mL)||Standard Deviation|Mean
1384286|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)|"Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax.~The mean Tmax value was adjusted to a 20 mg dose."|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.~One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."|||hour (h)||Standard Deviation|Mean
1384287|NCT01417078|Secondary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|"TEAEs refer to adverse events with start dates occurring after dosing. Treatment-Related TEAEs refer to those 'possibly' or 'probably' related to study drug.~Intensity definitions:~Mild: Usually transient, required no special treatment, and did not interfere with the patient’s daily activities.~Moderate: Usually caused a low degree of inconvenience or concern to the patient, and may have interfered with daily activities, but was usually ameliorated by simple therapeutic measures.~Severe: Interrupted a patient’s usual daily activities, and generally required systemic drug therapy or other treatment."|Pre-dose to 48 hours post-dose|Safety Population (dosed with study drug)|||participants|||Number
1384288|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),|Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.~One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1384303|NCT01416584|Other Pre-specified|In Methadone Treatment at End of Treatment|Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
1384289|NCT01417026|Secondary|"Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention"|"The Happy Faces task requires that participants look at a series of faces of men and women. Faces are presented on the screen one by one and children are asked just to look at the faces. Eye movements are measured with a Tobii x120 tabletop eye-tracker to evaluate participants’ looking patterns towards the eyes versus the mouth region."|Baseline and Post-testing (after max. 12 days)||||change in proportion of looking||Standard Deviation|Mean
1384290|NCT01417026|Primary|Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)|This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.|Baseline and Post-testing (after max. 12 days)||||change in items correct||Standard Deviation|Mean
1384291|NCT01417026|Primary|Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)|This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.|Baseline and Post-testing (after max. 12 days)||||change in percent correct||Standard Deviation|Mean
1384292|NCT01417000|Secondary|To Assess Safety of the Cyclophosphamide, GVAX Pancreas Vaccine, and CRS-207 Treatment Regimen|Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs. AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date.|Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.|Analysis conducted for the FAS of each study arm.|||Participants|||Count of Participants
1384293|NCT01417000|Primary|Overall Survival (OS) in Subjects Receiving Test Treatments (FAS)|"For all treated subjects, OS was defined as the time between the date of randomization and the date of death or censoring, and was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects without documentation of death at the time of the final analysis were censored using the date the subject was last known to be alive. Per the study protocol, following an Interim Analysis (IA), subjects in the Cy/GVAX arm were offered rollover to Cy/GVAX + CRS-207 arm. 3 subjects rolled over to the Cy/GVAX + CRS-207 arm (rollover subjects). These rollover subjects were censored at the day prior to the first rollover treatment dose date, and were included for analysis in the Cy/GVAX arm. Additionally, 2 subjects originally treated per the Cy/GVAX + CRS-207 arm discontinued treatment and entered follow-up, but following IA were re-treated per the Cy/GVAX + CRS-207 arm regimen. Data from these re-treated subjects were included in the Cy/GVAX + CRS-207 arm analysis."|Subjects were followed from the date of randomization to the date of death or discontinuation, whichever came first, assessed up to 60 months.|Analysis conducted for the FAS of each study arm.|||months||95% Confidence Interval|Median
1384294|NCT01416610|Secondary|Beck Depression Inventory (BDI) Score by Visit|The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
1384295|NCT01416610|Secondary|Beschwerdeliste (BL) Score by Visit|"The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit."|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
1384296|NCT01416610|Secondary|Fatigue Severity Scale (FSS) Score by Visit|The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
1384297|NCT01416610|Secondary|Short Form Health Survey (SF-36) Scores by Visit|The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
1384298|NCT01416610|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|by end of follow-up, within 3 years, 6 months|Participants who completed treatment|||percentage of participants||95% Confidence Interval|Number
1384299|NCT01416610|Secondary|Percentage of Participants With End of Treatment Response|A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|at end of treatment, within 3 years, 6 months||||percentage of participants||95% Confidence Interval|Number
1384300|NCT01416610|Secondary|Percentage of Participants With SVR 12|SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|12 weeks after completing treatment, within 3 years, 6 months||||percentage of participants||95% Confidence Interval|Number
1384305|NCT01416584|Other Pre-specified|Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?|The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.|6 months|Due to the very low rate of reports of going to a shooting gallery/house or other place where users go to shoot-up in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
1384306|NCT01416584|Other Pre-specified|Did Participant Share Needles or Works?|Percent of months that participants reported sharing needles or works.|6 months|Due to the very low rate of reports of sharing needles or works in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
1384307|NCT01416584|Secondary|Percentage of M,W,F Urine Samples Negative for Opiates|Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?|6 months|intent to treat|||percentage of M,W,F urine samples||Full Range|Mean
1384308|NCT01416584|Secondary|Percentage of M,W,F Urine Samples Negative for Cocaine|Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?|6 months|intent to treat|||percentage of urine samples||Full Range|Mean
1384309|NCT01416584|Primary|Percentage of Monthly Urine Samples Negative for Cocaine|Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?|6 months|intent to treat|||percentage of cocaine negative||Full Range|Mean
1384310|NCT01416584|Primary|Percentage of Monthly Urine Sample Negative for Opiates|Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation|6 months|Intent to treat|||percentage of opiate negative||Full Range|Mean
1384311|NCT01416584|Primary|Percentage of Months in Methadone Treatment|The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?|6 months|Intent to treat|||percent of months in methadone treatment||Full Range|Mean
1384312|NCT01416571|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384313|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 20 and from Day 0 to Day 84.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384314|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384315|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384316|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384348|NCT01416181|Secondary|Part 2: Summary of New/Enlarging T2 Lesion Counts|New or enlarging T2 lesions as measured by MRI.|Baseline (Part 1) up to Week 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||lesions||Standard Deviation|Mean
1396450|NCT01297322|Secondary|Device Success|Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression|Up to 1 day||||participants|||Number
1384317|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384318|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384319|NCT01416571|Secondary|Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384320|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384321|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384322|NCT01416571|Secondary|Duration of Solicited General Symptoms After Vaccination.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.|||days||Inter-Quartile Range|Median
1384323|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384324|NCT01416571|Secondary|Duration of Solicited Local Symptoms After Vaccination.|Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.|||days||Inter-Quartile Range|Median
1384325|NCT01416571|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Subjects|||Number
1384326|NCT01416571|Secondary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||ratio||95% Confidence Interval|Geometric Mean
1384349|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in Whole Gray Matter Brain Volume|Whole grey matter brain volume as measured by MRI.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
1384327|NCT01416571|Secondary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||Subjects|||Number
1384328|NCT01416571|Secondary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||Subjects|||Number
1384329|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||titers||95% Confidence Interval|Geometric Mean
1384330|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||Subjects|||Number
1384331|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||titers||95% Confidence Interval|Geometric Mean
1384332|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||Subjects|||Number
1384333|NCT01416571|Primary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||Subjects|||Number
1384334|NCT01416571|Primary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||ratio||95% Confidence Interval|Geometric Mean
1384335|NCT01416571|Primary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||Subjects|||Number
1384336|NCT01416389|Secondary|Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355|The intracycle accumulation ratio (Ra) is defined as the LY2523355 Cmax on Day 3 of Cycle 1 to the LY2523355 Cmax on Day 1 of Cycle 1 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.|Cycle 1: Day 1 and Day 3|Participants who received 1-dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.|||unitless ratio||Geometric Coefficient of Variation|Geometric Mean
1384337|NCT01416389|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307|Cmax is the maximum plasma concentration of LSN2546307 (metabolite) after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.|Cycle 1: Day 1 and Day 3|Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LSN2546307 Cmax on Day 1 and Day 3 of Cycle 1.One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1384510|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16|The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed||||||
1384338|NCT01416389|Other Pre-specified|Percentage of Deaths on Study Through the Follow-up Period|"The percentage of participants who died through the follow-up period of the study; the cause of death was not captured.~A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module."|Baseline through end of treatment follow-up (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||percentage of participants|||Number
1384339|NCT01416389|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355|Cmax is the maximum plasma concentration of LY2523355 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.|Cycle 1: Day 1 and Day 3|Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1384340|NCT01416389|Secondary|Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)|"Clinical benefit rate is the proportion of participants who achieve a best response of complete response (CR), partial response (PR), or stable disease (SD) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease, taking as reference the smallest sum diameter since treatment started.~Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with measurable disease, multiplied by 100."|Baseline to measured progressive disease or date of death from any cause (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||percentage of responders||90% Confidence Interval|Number
1384341|NCT01416389|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is the time from the date of randomization to the first date of progressive disease (PD) or death due to any cause, whichever occurs first. PD is as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines, and is defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 millimeter (mm) (the appearance of 1 or more new lesions was considered progression). Kaplan-Meier analysis was performed on the observed distribution of PFS. Participants were censored from analysis for the following reasons: lack of disease assessment, lost to follow-up, and further anticancer therapy started. Median PFS is presented.|Baseline to measured progressive disease or date of death from any cause (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). The total number of participants censored is 7. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||months||90% Confidence Interval|Median
1384342|NCT01416389|Secondary|Percentage of Participants Achieving an Overall Response (Overall Response Rate)|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.|Baseline to measured progressive disease or date of death from any cause (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||percentage of responders||90% Confidence Interval|Number
1384343|NCT01416389|Primary|Change in Tumor Size (CTS) From Baseline to the End of Cycle 2|The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.|Baseline up to end of Cycle 2 (Day 42)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone) and who had target lesion measurements at both baseline and the end of Cycle 2. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||log ratio of end of Cycle 2 to baseline||Standard Deviation|Mean
1384344|NCT01416272|Secondary|Visual Acuity - High Contrast|High contrast visual acuity measured with high ambient illumination (HCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.||||||
1384345|NCT01416272|Secondary|Visual Acuity - Low Contrast|Low contrast visual acuity measured with high ambient illumination (LCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.||||||
1384346|NCT01416272|Primary|Comfort|Symptoms and complaints measured on an analog scale|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.||||||
1384347|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in Number of New/Enlarging T2 Lesions|New or enlarging T2 lesions as measured by MRI.|Baseline (Part 1) and Weeks 156 and 204|Summary new/enlarging T2 lesion values are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data up to Week 204, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary, and the analysis was not done.||||||
1384350|NCT01416181|Secondary|Part 2: Percentage Change From Week 24 (Part 1) in Whole Brain Volume|Whole brain volume as measured by MRI.|Week 24 (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
1384351|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 2) in the WPAI-MS Questionnaire|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (WPL; percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (AI; percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Part 2 Baseline (Week 108) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
1384352|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 2) in the Work Productivity and Activity Impairment – Multiple Sclerosis (WPAI-MS) Questionnaire|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Part 2 Baseline (Week 108) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2) who had an assessment at Baseline and given time point.|||percentage of impairment||Standard Deviation|Mean
1384353|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the SDMT|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).|Baseline (Part 1) and every 4 weeks from Week 108 to Week 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data up to Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary, and the analysis was not done.||||||
1384354|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the Symbol Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).|Baseline (Part 1) and every 4 weeks from Week 108 to Week 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2). Missing values were imputed using last observation carried forward.|||units on a scale||Standard Deviation|Mean
1384355|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the MSIS-29 Physical Score|The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline (Part 1) and Weeks 156, 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data on Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary.||||||
1384356|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the MSIS-29 Physical Score|The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2) who had an assessment at Baseline and given time point.|||units on a scale||Standard Deviation|Mean
1384357|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the 6MWT|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|Baseline (Part 1) and Weeks 156, 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data on Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary.||||||
1384358|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the 6-Minute Walk Test (6MWT)|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||meters||Standard Deviation|Mean
1384359|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in EDSS|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
1385621|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||percentage of blood volume||Standard Deviation|Mean
1384360|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in EDSS|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||units on a scale||Standard Deviation|Mean
1384361|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
1384362|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||seconds||Standard Deviation|Mean
1384363|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
1384364|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||seconds||Standard Deviation|Mean
1384365|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in T25FW|The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
1384366|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in T25FW|The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Lower scores on time taken to reach 25 foot mark reflect a better outcome. Values are presented for the overall group, as well as the Confirmed Progressor (CP, defined in the primary outcome measure description above) and Non-Progressor (NP) subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||seconds||Standard Deviation|Mean
1384388|NCT01415986|Primary|Local Tumor Response to Interstitial Photodynamic Therapy (I-PDT) With Temoporfin|Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment|No data was collected because the participant was lost to follow up.||||||
1384389|NCT01415960|Secondary|Determination of Leuprolide Tmax|Leuprolide Pharmacokinetic Parameters (PK Population).|84 days||||day||Standard Deviation|Mean
1384511|NCT01414166|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16|The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.|Baseline and Weeks 12 to 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384367|NCT01416181|Secondary|Part 2: Percentage of Participants With Disability Worsening at 156 Weeks|Percentage of participants with disability worsening at each scheduled efficacy visit in Part 2, defined as one or more of the following: • ≥ 20% worsening from Part 1 baseline in T25FW; • ≥ 20% worsening from Part 1 baseline in 9HPT; • Worsening from Part 1 baseline in EDSS (≥ 1 point increase if Part 1 baseline EDSS ≤ 5.5 or ≥ 0.5 point increase if Part 1 baseline EDSS > 5.5). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. 95% CIs of percentages are based on normal approximation.|Week 156|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2).|||percentage of participants||95% Confidence Interval|Number
1384368|NCT01416181|Secondary|Part 1: Percentage of Participants Defined as Confirmed Progressors on EDSS Functional System Scores|"The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who met one of the following criteria:~an increase of ≥ 1 point from baseline system score of ≥ 1 or an increase of ≥ 2 points from baseline system score of 0 in at least 2 physical functional systems, or~an increase of ≥ 2 points from baseline system score of ≥ 1 or an increase of ≥ 3 points from baseline system score of 0 in any 1 physical functional system.~A confirmed progressor was defined as a participant who met the criteria for disability progression at any given visit and at the 6-Month Confirmation Visit. The 95% CIs are based on normal approximation."|Up to 96 weeks|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment.|||percentage of participants||95% Confidence Interval|Number
1384369|NCT01416181|Secondary|Part 1: Percentage Change From Week 24 in Whole Brain Volume at Week 96|Whole brain volume as measured by MRI.|Week 24 and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Includes those participants with an assessment at Weeks 24 and 96.|||percentage change||Standard Deviation|Mean
1384370|NCT01416181|Secondary|Part 1: Change From Baseline in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) Score|The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant’s perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||units on a scale||Standard Deviation|Mean
1384371|NCT01416181|Secondary|Part 1: Change From Baseline in Manual Ability Score Based on the ABILHAND Questionnaire|The ABILHAND Questionnaire measures the participant’s perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability. A positive number on change from baseline value indicates an improvement in ABILHAND.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||units on a scale||Standard Deviation|Mean
1384372|NCT01416181|Secondary|Part 1: Change From Baseline in the 12-Item MS Walking Scale (MSWS-12)|MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A negative number on change from BL value indicates an improvement in MSWS-12.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||units on a scale||Standard Deviation|Mean
1384373|NCT01416181|Secondary|Part 1: Percentage of Participants With a T25FW Response|T25FW response is defined as any improvement from the best pre-dose T25FW in at least 75% of the scheduled on-treatment visits through Week 96. The T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. The score for the T25FW is the average of the 2 completed trials. The 95% CI of the percentage is based on normal approximation.|Up to 96 weeks|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||percentage of participants||95% Confidence Interval|Number
1384374|NCT01416181|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE may have also been any other medically important event in the opinion of the Investigator.|218 weeks|Safety population: all participants who were randomized in Part 1 and received at least 1 infusion of study treatment in Part 2.|||participants|||Number
1384512|NCT01414153|Secondary|Proportion of Subjects With Adverse Events.||Baseline to Day 120||||percentage of subjects|||Number
1384375|NCT01416181|Primary|Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT)|"Confirmed disability progression, defined as ≥1 of the following criteria (confirmed at a second visit ≥6 months later and at Week 96):~Confirmed progression in EDSS (EDSS score increased from baseline [BL] by ≥1 point if BL EDSS ≤5.5 or by ≥0.5 points if BL EDSS ≥6);~Confirmed progression in T25FW (T25FW increased by ≥20% of the BL walk);~Confirmed progression in 9HPT (9HPT increased by ≥20% of the time taken at BL on either hand and confirmed on the same hand).~The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. The 95% confidence interval (CI) of the percentage is based on normal approximation."|Up to 96 weeks (2 years)|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment.|||percentage of participants||95% Confidence Interval|Number
1384376|NCT01416155|Secondary|Mean Change From Baseline in the Assessment of Expanded Disability Status Scale (EDSS) up to Week 192|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.|Day 1 up to Week 192|n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1384377|NCT01416155|Secondary|Adjusted Annualized Relapse Rate|Clinical relapses are defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist. The annualized relapse rate is calculated overall as the total number of relapses experienced in the study divided by the number of days followed in the study, and the ratio multiplied by 365. Obtained from a Poisson regression model, adjusted for the baseline relapse rate from study 101MS203 (NCT01440101).|Day 1 up to approximately 50 months||||relapses per subject-years|Participants|95% Confidence Interval|Number
1384378|NCT01416155|Primary|Number of Participants With Serum Antibodies to Natalizumab|Negative is defined as negative for antibodies at all post-baseline results. Transient positivity is defined as only 1 positive result. Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Day 1 up to approximately 50 months|Immunogenicity population: all participants who had received at least 1 infusion of BG00002, were negative for BG00002 antibodies at baseline and had at least 1 nonmissing post-baseline assessment of antibody status.|||participants|||Number
1384379|NCT01416155|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|Day 1 through First Follow-Up (12 Weeks After Last Infusion) +/- 7 days. Approximately 62 months|Safety population: all participants who received at least 1 dose of study treatment.|||participants|||Number
1384380|NCT01416142|Secondary|Preference for Test Lens|Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.|During the movie (Visit 2)|All eligible, dispensed subjects|||participants|||Number
1384381|NCT01416142|Primary|Visual Acuity|Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.|Screening visit (Visit 1) and one week follow-up(Visit 3)|Mean scores are based on the number of eyes with nonmissing logMAR VAs. All eligible, dispensed eyes while wearing spectacles vs. wearing PureVision2 lenses.|||logMAR|Participants|Standard Deviation|Mean
1384382|NCT01416129|Primary|Socket Pressure|Pressure sensors are placed on the skin and measured.|10 minutes after fitting with both sockets||||mm Hg||Standard Deviation|Mean
1384383|NCT01416129|Primary|Quality of Life|Validated surveys will be used to solicit participants' subjective experience and feedback.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||||||
1384384|NCT01416129|Primary|Balance and Stability|Balance and stability will be assessed for limits of stability and postural stability.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||||||
1384385|NCT01416129|Primary|Gait|Gait will be assessed in terms of biomechanics and spatiotemporal parameters.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||||||
1384386|NCT01416025|Primary|Number of Participants With Treatment Failure|"The primary endpoint of the study will be a binary outcome, called Failure, defined as one of the following: measured at 42 days from initiation of drug administration:~Progression of underlying infection (clinical failure)~Death~Development of a voriconazole-associated SAE: LFTs, Rash, Visual disturbance, Neurologic abnormality (e.g: hallucinations)"|42 days||||participants|||Number
1384387|NCT01415986|Secondary|Changes in the Quality of Life (QoL)|The change in the overall score of the University of Washington quality of life questionnaire (UW-QOL). Each of the domain-specific items is scored from 0 (worst quality of life (QOL) to 100 (Best QOL). The composite score is created by averaging the scores.|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment.|No data was collected because the participant was lost to follow up.||||||
1385622|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||percentage of blood volume||Standard Deviation|Mean
1384390|NCT01415960|Secondary|Safety Endpoints|"The WHO/ECOG, bone pain, urinary pain and urinary symptoms data reported are the most frequent percentage at the assessment time.~The WHO/ECOG performance status was summarized using the 0 to 4 WHO/ECOG performance status scale. (0= fully active, able to carry on all pre-disease performances without restriction).~Bone pain, urinary pain and urinary symptoms were determined using a 10-point scale (1= no pain/symptoms, 10= worst pain/symptom imaginable)."|168 Days|Safety endpoints adverse events (AEs), local tolerability, vital signs, performance status, bone pain, urinary pain, and urinary symptoms, occurrence of hot flushes and clinical laboratory and electrocardiogram (ECG) results.|||percentage of participants|||Number
1384391|NCT01415960|Secondary|Determination of Leuprolide Cmax|Leuprolide Pharmacokinetic Parameters (PK Population).|Cmax1: 0, 1 and 4 hours post-dose on Day 0 and once on Days 2, 14, 28, 56; Cmax2: 0, 1 and 4 hours post-dose on Day 84 and once on Days 86, 112 and 168.||||ng/mL||Standard Deviation|Mean
1384392|NCT01415960|Secondary|Prostate-specific Antigen (PSA) Concentrations|For purposes of calculating summary statistics, any concentration values Below Limit Quantification (BLQ) were to be assigned ½ the Low Limit Quantification (LLOQ) (LLOQ=0.36). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.|168 days||||ng/mL||Standard Deviation|Mean
1384393|NCT01415960|Secondary|Follicle-stimulating Hormone (FSH)|For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=3.66). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was to be calculated for that time point.|168 days||||mIU/mL||Standard Deviation|Mean
1384394|NCT01415960|Secondary|Determination of Serum Luteinizing Hormone (LH)|For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=2.00). If the calculated mean, median or minimum value at a time point was less than LLOQ, “BLQ” is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point.|168 days||||mIU/mL||Standard Deviation|Mean
1384395|NCT01415960|Primary|Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168.|The primary endpoint was testosterone ≤ 0.5 ng/mL assessed on Days 28, 84, and 168. Thereby, maintenance of castration was to be demonstrated through Day 168 with no missing data at these key time points, unless the missing data were due to an event unrelated to the study drug (ITT patients).|168 days||||percentage of participants||95% Confidence Interval|Number
1384396|NCT01415921|Primary|Post Exercise Heart Rate Recovery|Change in heart rate from peak exercise to 1 minute post-exercise (beats per minute)|12 weeks|Heart rate recovery is also measured as beats/min (peak HR at end of exercise – HR 1 min post exercise = HRR).|||beats per minute||Standard Deviation|Mean
1384397|NCT01415921|Primary|Baseline Heart Rate Recovery|Change in peak HR at end of exercise to 1 minute post-exercise (beats per minute)|Baseline|Heart rate recovery is also measured as beats/min (peak HR at end of exercise – HR 1 min post exercise = HRR).|||beats per minute||Standard Deviation|Mean
1384398|NCT01415908|Secondary|Hospital Stay||During the time of hospital stay||||days||Standard Deviation|Mean
1384399|NCT01415908|Secondary|Blood Loss||During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group||||mls||Standard Deviation|Mean
1384400|NCT01415908|Secondary|Operative Time||Operative time was recorded from skin incision to wound closure||||minutes||Standard Deviation|Mean
1384401|NCT01415908|Secondary|Percent of Subjects Who Had Additional Surgical Procedures/Interventions||24 months||||percentage of participants|||Number
1384402|NCT01415908|Secondary|Success Rate of General Health Status|The Medical Outcomes Study 36-Item Short Form (SF-36) health survey was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The scores for PCS and MCS are between 0 and 100, with higher scores denoting better quality of life. To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: post-operative score - pre-operative score >= 0. The results are reported as percent of subjects who have SF-36 PCS success, SF-36 MCS success, and overall SF-36 success.|24 months||||percentage of participants|||Number
1384403|NCT01415908|Secondary|Success Rate of Leg Pain|Numerical rating scales were used to evaluate leg pain intensity and frequency. Subjects rated their leg pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, subjects recorded their leg pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” The total leg pain score were the sum of pain intensity and frequency scores. Success rate of leg pain is reported as percent of subjects whose leg pain improvement met: pre-operative score - post-operative score > 0.|24 months||||percentage of participants|||Number
1384404|NCT01415908|Secondary|Success Rate of Back Pain|Numerical rating scales were used to evaluate back pain intensity and frequency. Subjects rated their back pain intensity on a scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be.” Similarly, subjects recorded their back pain frequency on a scale from 0-10, with a score of 0 being “pain none of the time” and a score of 10 being “pain all of the time.” The total back pain score were the sum of pain intensity and frequency scores. Success rate of back pain is reported as percent of subjects whose back pain improvement met: pre-operative score - post-operative score > 0.|24 months||||percentage of participants|||Number
1384405|NCT01415908|Secondary|Success Rate of Neurological Status|Neurological status was assessed in six sections: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections had a number of elements. Success rate of neurological status is reported as percent of subjects whose neurological status was maintained or improved in three key neurological assessments—motor, sensory, and deep tendon reflexes.|24 months||||percentage of participants|||Number
1384406|NCT01415908|Secondary|Success Rate of Oswestry Disability Index|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.|24 months||||percentage of participants|||Number
1384407|NCT01415908|Secondary|Rate of Fusion Success|"Rate of fusion success is reported as percent of subjects having fusion success. The fusion success was defined radiologically as:~evidence of bridging bone;~no evidence of motion;~no evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface."|24 months|Eight investigational and 3 control subjects were evaluated for fusion success at 24 months.|||percentage of participants|||Number
1384408|NCT01415908|Primary|Rate of Overall Success|"Rate of overall success is reported as percent of subjects who met all of the following criteria:~fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion);~pain/disability (Oswestry Disability Index) success;~neurological status success;~no serious adverse event classified as implant associated or implant/surgical procedure associated;~no additional surgical procedure classified as a failure."|24 months||||percentage of participants|||Number
1384409|NCT01415583|Primary|Number of Participants With Post-tonsillectomy Bleeding||2 weeks after surgery||||participants||97.5% Confidence Interval|Number
1384410|NCT01415531|Secondary|Trough Seated Systolic Blood Pressure (SBP)|Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment|||mm Hg||Standard Deviation|Mean
1384411|NCT01415531|Primary|Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment|||mmHG||Standard Deviation|Mean
1384412|NCT01415518|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the whole treatment period (12 weeks)||||times/day||95% Confidence Interval|Least Squares Mean
1384413|NCT01415518|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
1384414|NCT01415518|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the last week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
1384415|NCT01415518|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period (12 weeks)||||exacerbations/12 weeks||95% Confidence Interval|Least Squares Mean
1384416|NCT01415518|Secondary|COPD Symptoms Sputum|Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)||||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
1384417|NCT01415518|Secondary|COPD Symptoms - Cough|Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)||||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
1384418|NCT01415518|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)||||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
1384419|NCT01415518|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period (12 weeks)||||times/day||95% Confidence Interval|Least Squares Mean
1384420|NCT01415518|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
1384421|NCT01415518|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
1384422|NCT01415518|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period (12 weeks)||||L/min||95% Confidence Interval|Least Squares Mean
1384423|NCT01415518|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured at 5 minutes after inhalation of study drug in the first week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
1384424|NCT01415518|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
1384425|NCT01415518|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period (12 weeks)||||L/min||95% Confidence Interval|Least Squares Mean
1384426|NCT01415518|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured before inhalation of study drug in the first week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
1384427|NCT01415518|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
1384428|NCT01415518|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
1384429|NCT01415518|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
1384430|NCT01415518|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
1384431|NCT01415518|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
1384432|NCT01415518|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
1384433|NCT01415518|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS|||Ratio||95% Confidence Interval|Geometric Mean
1384434|NCT01415518|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS|||Ratio||95% Confidence Interval|Geometric Mean
1384435|NCT01415518|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS|||Ratio||95% Confidence Interval|Geometric Mean
1384436|NCT01415453|Primary|Phosphene Perception in Response to Ultrasound Pulse.|The investigators will test the hypothesis that compression of retinal nerves by ultrasound force will cause perception of light (phosphenes) in blind subjects lacking functioning photoreceptors (retinitis pigmentosa). With each of two 5 msec ARFI exposures, if the subject either perceived the spark of light (phosphene), then it was documented as a positive response; if they did not, it was marked as a negative response.|Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.|Only one subject was examined.|||participants|||Number
1384437|NCT01415427|Secondary|Change From Baseline in Urine Keratan Sulfate - MPP|Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks|||ug/mg||Standard Deviation|Mean
1384438|NCT01415427|Secondary|Change From Baseline in Urine Keratan Sulfate - ITT|Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not|||ug/mg||Standard Deviation|Mean
1384439|NCT01415427|Secondary|Change From Baseline in 3-minute Stair Climb Test - MPP|Efficacy was assessed by changes from baseline in 3-minute stair climb test.|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks|||stairs/min||Standard Deviation|Mean
1384440|NCT01415427|Secondary|Change From Baseline in 3-minute Stair Climb Test - ITT|Efficacy was assessed by changes from baseline in 3-minute stair climb test.|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not|||stairs/min||Standard Deviation|Mean
1384441|NCT01415427|Primary|Change From Baseline in 6-minute Walk (6MW) Test - MPP|Efficacy was assessed by changes from baseline in 6-minute walk test|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks.|||meters||Standard Deviation|Mean
1402517|NCT01243320|Primary|Change in Albumin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||g/dL||95% Confidence Interval|Mean
1384443|NCT01415401|Secondary|Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|This analysis population includes all subjects who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||percentage of participants|||Number
1384444|NCT01415401|Primary|Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|This analysis population includes all subjects who received study medication and had at least one on-therapy study visit. Last observation carried forward (LOCF) was used.|||mmHg||Standard Deviation|Mean
1384445|NCT01415349|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.|||ng*h/ml||Standard Deviation|Mean
1384446|NCT01415349|Primary|Maximum Plasma Concentration (Cmax) for SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.|||ng/ml||Standard Deviation|Mean
1384447|NCT01415232|Primary|Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)|Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.|at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)|per protocol|||correlation coefficient||95% Confidence Interval|Number
1384448|NCT01414855|Secondary|Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count||Up to approximately 24 months|||||||
1384449|NCT01414855|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)|Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||day*μg/mL||Standard Deviation|Mean
1384450|NCT01414855|Secondary|Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab|V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||mL||Standard Deviation|Mean
1384451|NCT01414855|Secondary|Pharmacokinetics: Clearance (Cl) for Obinutuzumab|Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||mL/day||Standard Deviation|Mean
1384452|NCT01414855|Secondary|Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab|T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||days||Standard Deviation|Mean
1384453|NCT01414855|Secondary|Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab|Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||μg/mL||Standard Deviation|Mean
1384454|NCT01414855|Secondary|Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)|SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes. Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|Participants from the Safety population, all randomized participants who received at least 1 dose of study drug, who received shorter duration infusions.|||participants|||Number
1402518|NCT01243320|Primary|Change In Total Bilirubin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
1384455|NCT01414855|Secondary|Percentage of Participants With Adverse Events as a Measure of Safety|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.|From the first dose of study treatment to end of study (up to 5 years 4 months)|Safety population included all randomized participants who received study drug.|||percentage of participants|||Number
1384456|NCT01414855|Secondary|Duration of Response (DOR)|DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the response assessment to relapse, progression, or death (up to 64 months)|All participants with data available. Participants who had not progressed, relapsed, or died at the time of analysis were censored for duration of response at the date of the last valid response assessment.|||months||Full Range|Median
1384457|NCT01414855|Secondary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.|From the first dose of study treatment to PFS assessment (up to 64 months)|All participants. Patients who had not progressed, relapsed or died at the time of analysis were censored on the date of last valid disease assessment. If no tumor assessments were performed after the baseline visit, the patient was censored for PFS at the date after the first dose of study treatments.|||months||95% Confidence Interval|Median
1384458|NCT01414855|Secondary|Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants|||percentage of participants||95% Confidence Interval|Number
1384459|NCT01414855|Secondary|Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.|||percentage of participants||95% Confidence Interval|Number
1384460|NCT01414855|Primary|Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants|||percentage of participants||95% Confidence Interval|Number
1384461|NCT01414855|Primary|Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.|||percentage of participants||95% Confidence Interval|Number
1384462|NCT01414634|Primary|Number of Adverse Events||3 months after treatment||||Number of AE|||Number
1384463|NCT01414634|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||12 months|||||||
1384464|NCT01414413|Secondary|Adult Mortality|Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention|The first 6-months following availability of home-based HIV testing|||||||
1384465|NCT01414413|Secondary|Adherence to ART|Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period|First 6-months following availability of home-based HIV testing|||||||
1384466|NCT01414413|Secondary|Loss to Retention|Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months|The first 6-months following availability of home-based HIV testing||||participants|||Number
1384467|NCT01414413|Secondary|Reporting of HIV-positive Results|Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period|The first 6-months following availability of home-based HIV testing||||participants|||Number
1384468|NCT01414413|Secondary|Uptake of Home-based HIV Testing|Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study.|The first 6-months following home assessment and initiation of ART being made available||||participants|||Number
1384469|NCT01414413|Primary|ART Initiation|Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.|First six months following introduction of home-based HIV testing||||participants|||Number
1384971|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|The proportion (per cent) of the total number of sperm cell with abnormal appearance.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.|||Per cent||Standard Deviation|Geometric Mean
1384470|NCT01414257|Secondary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assesable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of methotrexate was assessed as “effective” or “ineffective” by the investigator. The assessment was based on the baseline condition of disease control and degree of alleviation from baseline in clinical symptoms and laboratory data.|24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (clinical efficacy rate) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants||95% Confidence Interval|Number
1384471|NCT01414257|Secondary|Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events|Pre-specified important adverse events were 1) Interstitial pneumonia, 2) Pulmonary fibrosis, 3) Hepatic impairment, 4) Renal impairment, 5) Hematopoietic disorder, 6) Infection, and 7) Lymphoma. A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.|24 Weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received methotrexate at least once.|||Participants|||Number
1384472|NCT01414257|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.|24 Weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received methotrexate at least once.|||Participants|||Number
1384473|NCT01414257|Primary|Change From Baseline in Disease Activity Score (DAS28)-4CRP|Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 [CRP]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. Mean change from baseline in the DAS28-4 (CRP) at Week 24 is calculated. The total scale range can not be specified.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (CRP) at least once. Participants with observed change in DAS28-4 (CRP) were included in table.|||Score||Standard Deviation|Mean
1384474|NCT01414257|Primary|Change From Baseline in Disease Activity Score (DAS28)-4ESR|Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 [ESR]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Mean change from baseline in the DAS28-4 (ESR) at Week 24 is calculated. The total scale range can not be specified.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (ESR) at least once. Participants with observed change in DAS28-4(ESR) were included in table.|||Score||Standard Deviation|Mean
1384475|NCT01414257|Primary|Disease Activity Score (DAS28)-4CRP|Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 [CRP]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (CRP) >4.1 indicated high disease activity, ≥2.7 to 4.1 indicated moderate disease activity, <2.7 indicated low disease activity, and <2.3 indicated remission.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (CRP) at least once. Participants with observed DAS28-4(CRP) were included in table.|||Score||Standard Deviation|Mean
1384476|NCT01414257|Primary|Disease Activity Score (DAS28)-4ESR|Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 [ESR]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Higher score indicated more disease activity. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (ESR) >5.1 indicated high disease activity, ?3.2 to ?5.1 indicated moderate disease activity, <3.2 indicated low disease activity, and <2.6 indicated remission.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (ESR) at least once. Participants with observed DAS28-4(ESR) were included in table.|||Score||Standard Deviation|Mean
1384477|NCT01414257|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate.|24 Weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received methotrexate at least once.|||Participants|||Number
1384478|NCT01414244|Secondary|Stool Consistency|Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome.|Baseline and 8 weeks following therapy||||units on a scale (1-7)||Standard Deviation|Mean
1384479|NCT01414244|Secondary|Stool Frequency|Baseline and 8 week at the conclusion of therapy|Baseline and 8 weeks following therapy||||stools per day||Standard Deviation|Mean
1384480|NCT01414244|Secondary|Intestinal Permeability|The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol.|baseline and 8 weeks following therapy||||lactulose/mannitol (L/M)||Standard Deviation|Mean
1402519|NCT01243320|Primary|Change In Total Protein Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||g/dL||95% Confidence Interval|Mean
1384481|NCT01414244|Primary|Change in the Irritable Bowel Symptom Severity Scale|The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.|baseline and 8 weeks following therapy||||units on a scale||Standard Deviation|Mean
1384482|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as a CD19 result ≥ 0.07 × 10^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) [PD before B-cell recovery or PD within 45 days after recovery] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|Up to 4 years, 5 months|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, with B-Cell depletion.|||Participants|||Number
1384483|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell depletion was defined as a CD19 result < 0.07 × 10^9/L after at least one dose of study drug has been administered.|Up to 4 years, 5 months|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, who had data available for this outcome measure.|||Participants|||Number
1384484|NCT01414205|Secondary|PK: Serum Concentrations of Obinutuzumab (Follow-Up Visits)|Blood serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Months 3, 6, 9, and 12|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||μg/mL||Standard Deviation|Mean
1384485|NCT01414205|Secondary|PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). T1/2 was reported in Days.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||Days||Geometric Coefficient of Variation|Geometric Mean
1384486|NCT01414205|Secondary|PK Parameter: Volume of Distribution at Steady State (Vss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss is reported in liters.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1384487|NCT01414205|Secondary|PK Parameter: Clearance at Steady State (CLss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLss is reported in milliliters per day (mL/day).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
1384488|NCT01414205|Secondary|PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in day times micrograms per milliliter (day*μg/mL).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||day*μg/mL||Geometric Coefficient of Variation|Geometric Mean
1384489|NCT01414205|Secondary|PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for Pharmacokinetic (PK) Parameter Cmax after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Day 148 (at end of infusion)|All randomized participants who received study drug with PK data available for analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1384490|NCT01414205|Secondary|Percentage of Participants With Adverse Events Leading to Study Discontinuation|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1384491|NCT01414205|Secondary|Percentage of Participants With Adverse Events of Interest|Adverse Events of interest for this study were: serious infusion related reactions during or within 24 hours of infusion, serious neutropenia, serious infection, tumor lysis syndrome and Hepatitis B reactivation.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1384513|NCT01414153|Secondary|Proportion of Subjects With ETDRS BCVA of 20/40 or Better.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. 20/40 Snellen corresponds to a range of 69-73 letters by ETDRS.|Baseline to Day 120||||percentage of subjects||80% Confidence Interval|Number
1384492|NCT01414205|Secondary|Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1384493|NCT01414205|Secondary|Number of Participants Surviving at End-of-Study||Up to 4 years, 5 months|Intent-to-treat population included all randomized participants.|||Participants|||Number
1384494|NCT01414205|Secondary|Duration of Response||Up to 4 years, 5 months|||||||
1384495|NCT01414205|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.|Up to 4 years, 5 months|Intent-to-treat population included all randomized participants.|||Months||95% Confidence Interval|Median
1384496|NCT01414205|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes < 4 x 10^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils > 1.5 x 10^9/L, Platelets > 100 x 10^9/L, Hemoglobin >11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils > 1.5 x 10^9/L or > 50% of pretreatment value, Platelets > 100 x 10^9/L or 50% of pretreatment value and Hemoglobin > 11 g/dL or > 50% of pretreatment value.|Week 32|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1384497|NCT01414192|Secondary|Mortality Rate|The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.|up to 48 months|All enrolled participants with available data.|||Deaths per 100,000 patient-years||95% Confidence Interval|Number
1384498|NCT01414192|Secondary|Percentage of Participants With at Least 1 Discontinuation of Study Drug|The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.|up to 48 months|All enrolled participants with available data.|||Percentage of Participants|||Number
1384499|NCT01414192|Secondary|Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months|Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.|up to 48 months|All enrolled participants with available data. The ezetimibe monotherapy with or without previous lipid-lowering treatment groups were combined for this outcome.|||Percentage of Participants|||Number
1384500|NCT01414192|Secondary|Percentage of Participants With CV Risk Factors|Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.|At enrollment (baseline)|All enrolled participants with available data|||Percentage of Participants|||Number
1384501|NCT01414192|Secondary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months|LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.|Baseline and Month 12|All participants with available data for endpoint. The ezetimibe plus statin and ezetimibe/simvastatin arms were combined for this outcome.|||Percentage Change||Full Range|Mean
1384502|NCT01414192|Primary|Rate of Cardiovascular (CV) Events|Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.|up to 48 months|All participants with available data for endpoint.|||Events per 1000 patient-years||95% Confidence Interval|Number
1384503|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16|The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384504|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384505|NCT01414166|Secondary|Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16|The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384506|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16|The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384507|NCT01414166|Secondary|Percent Change From Baseline in Non-HDL-C at Week 16|The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384508|NCT01414166|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
1384554|NCT01413204|Secondary|Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test||Week 24|||||||
1384514|NCT01414153|Secondary|Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. One line is equivalent to 5 letters, so a loss of 3 lines is a loss of 15 letters.|Baseline to Day 120||||percentage of subjects||80% Confidence Interval|Number
1384515|NCT01414153|Secondary|Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120||||percentage of subjects||80% Confidence Interval|Number
1384516|NCT01414153|Secondary|Mean Change in CNV Lesion Area as Determined by Fluorescein Angiography (FA).||Baseline to Day 120|ITT population|||mm^2||Standard Error|Least Squares Mean
1384517|NCT01414153|Secondary|Mean Change in Central Subfield Retinal Thickness||Baseline to Day 120|ITT population|||μM||Standard Error|Least Squares Mean
1384518|NCT01414153|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120|Intent-to-treat (ITT) Population|||letters||Standard Deviation|Least Squares Mean
1384519|NCT01414114|Secondary|Percent Change From Baseline in Phosphorus During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data at both time points|||percent change||Standard Deviation|Mean
1384520|NCT01414114|Secondary|Percent Change From Baseline in Corrected Calcium During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data at both time points|||percent change||Standard Deviation|Mean
1384521|NCT01414114|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period|The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data|||percentage of participants||95% Confidence Interval|Number
1384522|NCT01414114|Secondary|Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period|The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data|||percentage of participants||95% Confidence Interval|Number
1384523|NCT01414114|Primary|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|The modified intent-to-treat population (all participants who were randomized and received treatment) with available data at both time points.|||percent change||Standard Deviation|Mean
1384524|NCT01414036|Secondary|Use of Other Tobacco Treatment Support|self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.|||participant|||Number
1384525|NCT01414036|Secondary|Stage of Change With Regard to Smoking Cessation|Stage of change is assessed at baseline and 3 months. Three months after study entry, 7 of patient navigation-intervention participants who had initially said that they did not have a time frame in mind for quitting reported that they now had a time frame in mind for quitting, relative to 1 of ETC-control participants.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.|||participant|||Number
1384526|NCT01414036|Primary|Engagement in Smoking Cessation Treatment|This is a dichotomous variable, Y/N, based on a) completion of > 1 quit line counseling session (based on self-report) OR b) > 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of > 1 session of a BMC smoking cessation group (medical record review).|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.|||participant|||Number
1384527|NCT01414010|Primary|Bacteria Prevalence in Stool|"The most prevalent bacterial genera within the study population~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56"|Day 0 to 56|The investigators expanded their studies on the probiotic (Saccharomyces boulardii) to constitute a full, separate study. Reference: NCT01473368.|||percentage of bacterial genera in stool||Standard Deviation|Mean
1384555|NCT01413204|Secondary|Change in Blood Pressure||Week 24|||||||
1384528|NCT01413958|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)|"The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3~questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains."|Up to Day 8|The Intent-To-Treat Population was used in this analysis. There were 285 evaluable participants for the Placebo Group at Day 8.|||Scores on a scale||Standard Deviation|Mean
1384529|NCT01413958|Secondary|Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 5 and 7, 287 on Days 1, 3, 4 and 286 on Days 2 and 6. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 5, 6 and 285 on Day 7 and 284 on Day 4.|||Scores on a scale||Standard Deviation|Mean
1384530|NCT01413958|Secondary|Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 1, 2, 3, 4, 5, 7 and 286 evaluable participants at Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 3, 5, 6 and 285 on Days 2, 4, 7.|||Scores on a scale||Standard Deviation|Mean
1384531|NCT01413958|Secondary|Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Day 5, 287 on Days 1, 3, 4, 6 and 286 on Day 2. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, 6, 285 on Days 3 and 7 and 284 on Day 4.|||Scores on a scale||Standard Deviation|Mean
1384532|NCT01413958|Secondary|Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 2 - 5 and 287 on Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, and 6 and 285 on Days 3, 4, and 7.|||Scores on a scale||Standard Deviation|Mean
1384533|NCT01413958|Secondary|Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
1384556|NCT01413204|Secondary|Change in Body Weight||Week 24|||||||
1384557|NCT01413204|Secondary|Change in Fasting Plasma Glucose||Week 24|||||||
1384558|NCT01413204|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||baseline and 24 weeks|Full analysis set, last observation carried forward|||percent HbA1C||Standard Error|Least Squares Mean
1384559|NCT01413191|Secondary|Tumor Shrinkage for All Efficacy-evaluable Patients||Up to 2 years|||||||
1384560|NCT01413191|Secondary|Overall Survival (OS)||Up to 2 years|||||||
1384561|NCT01413191|Secondary|Progression-free Survival (PFS)||Up to 2 years|||||||
1384534|NCT01413958|Secondary|Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Day 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and at Day 7 was 285.|||Scores on a scale||Standard Deviation|Mean
1384535|NCT01413958|Secondary|Time to Maximal Phenylephrine Effect|The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group.|Baseline up to Day 7|All participants in the intent-to-treat population (all randomized participants who received at least 1 tablet of study medication).|||Days|||Number
1384536|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Day 2 - 7. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6 and 285 on Day 7.|||Scores on a scale||Standard Deviation|Mean
1384537|NCT01413958|Secondary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Days 2 - 7. For Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6, and 285 on Day 7.|||Scores on a scale||Standard Deviation|Mean
1384538|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
1384539|NCT01413958|Secondary|Mean Change From Baseline in the Evening Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
1384540|NCT01413958|Secondary|Mean Change From Baseline in the Morning Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
1384541|NCT01413958|Primary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
1384542|NCT01413750|Secondary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose in which 33% or more of the patients experience a DLT. The MTD is based on the first cycle of therapy. The recommended Phase II dose is generally the MTD, although secondary considerations of toxicity and dose reductions on subsequent cycles and other secondary considerations may result in the recommended Phase II dose being below the MTD.|4 weeks from start of treatment, up to 1 year||||mg|||Number
1384543|NCT01413750|Secondary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III or higher non-hematological toxicity except nausea, vomiting or alopecia. Nausea or vomiting (> grade 2) that last longer than 48 hours despite maximal medical therapy. Absolute neutrophil count < 1000/uL lasting longer than 7 days. Grade 4 thrombocytopenia (platelet < 25,000/uL). Grade 3 or 4 neutropenia associated with sepsis or fever > 38 C. Delay in starting cycle 2 by more than 2 weeks due to toxicity.Abnormal non-hematological laboratory criteria (Grade 3 or higher) will be considered a DLT, if clinically significant and drug-related. If baseline value is elevated prior to drug therapy, an increase will not be considered a DLT unless there is an elevation by more than 2 grades, and it is of clinical significance. Dose escalation schedule for vorinostat: 600 mg QD; 800 mg QD.|4 weeks from start of treatment, up to 1 year||||participants with DLTs|||Number
1384544|NCT01413750|Primary|Progression-free Survival (PFS)|"Estimated using the product-limit method of Kaplan and Meier.~PFS defined as time from randomization to progression or death due to any cause.~Progression defined as Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year|Due to early termination phase II portion of the study did not reach planned accrual.|||months||95% Confidence Interval|Median
1384545|NCT01413542|Secondary|Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion||Blood for analysis of GLP-1 levels was obtained one hour after sitagliptin (DPP4 inhibition) vs. placebo administration and after each dose of GLP-1||||pmol/L||Standard Error|Mean
1384546|NCT01413542|Secondary|Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)||Blood for analysis of norepinephrine (NE) release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)||||pg/mL||Standard Error|Mean
1384547|NCT01413542|Secondary|Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)||Heart rate was measured every 5 minutes throughout the study day (and thus during each dose of peptide infusion)||||beats per minute||Standard Error|Mean
1384548|NCT01413542|Secondary|Assess Tissue Type Plasminogen Activator (tPA) Release|Following measurement of FBF, samples will be obtained to determine the effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) (group 1)|Blood for analysis of tPA release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)||||estimate of difference (ng/min/100mL)||95% Confidence Interval|Number
1384549|NCT01413542|Primary|The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).|Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined.|60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehicle|In Group 1: Peptide 1=Max dose Bradykinin; Peptide 2=Substance P (SP) In Group 2: Peptide 1=GLP-1; Peptide 2=BNP (FBF expressed as percent change for both peptides) ACE inhibition=enalaprilat DPP4 inhibition=sitagliptin|||estimate of difference(ml/min/100ml FBF)||95% Confidence Interval|Mean
1384550|NCT01413516|Primary|7 Day Point Prevalence Abstinence From All Forms of Tobacco|Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.|4 weeks after beginning study||||participants|||Number
1384551|NCT01413360|Secondary|The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks|Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level|Baseline and 12 weeks||||pg/mL||Full Range|Median
1384552|NCT01413360|Primary|The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks|Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level|Baseline and 12 weeks||||IU/L||Full Range|Median
1384553|NCT01413204|Secondary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs||Week 24|||||||
1384562|NCT01413191|Secondary|Duration of Response|Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.|From the date criteria are first met for complete or partial response until the first date of documented progression, assessed up to 2 years|||||||
1384563|NCT01413191|Secondary|Durable Response Rate (i.e., the Proportion of Subjects With a Confirmed Complete or Partial Response ≥ 6 Months in Duration)|The durable response rate will be presented and the adjusted 95% confidence interval will be calculated.|Up to 2 years|||||||
1384564|NCT01413191|Secondary|Disease Control Rate (i.e., the Proportion of Subjects With a Confirmed Complete or Partial Response of Any Duration or Stable Disease ≥3 Months in Duration)|The disease control rate will be presented and the adjusted 95% confidence interval will be calculated.|Up to 2 years|||||||
1384565|NCT01413191|Primary|Response Rate (% Participants With Complete or Partial Response)|Response rate is the percentage of subjects with a confirmed complete or partial response using revised Response Evaluation Criteria in Solid Tumors (RECIST) where changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria: Complete Response (CR): Disappearance all target lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): 30% or > decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): 20% or > increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study); and sum must demonstrate absolute increase of 5+ mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.|Baseline to 2 years|One participant was not evaluable for response assessment.|||participants|||Number
1384566|NCT01412983|Secondary|Overall Comfort|The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.|One week|All eligible dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
1384567|NCT01412983|Primary|Visual Acuity|The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.|One week|All eligible dispensed eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
1384568|NCT01412957|Secondary|Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).|Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)|QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment.|||msec||Standard Deviation|Mean
1384569|NCT01412957|Secondary|Number of Participants With Adverse Events (AEs)|The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.|From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.|Safety Analysis Set (all randomized participants)|||participants|||Number
1384570|NCT01412957|Secondary|Objective Response Rate in Participants With Wild-type RAS|Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set|||percentage of participants||95% Confidence Interval|Number
1384571|NCT01412957|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator’s assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT analysis set|||percentage of participants||95% Confidence Interval|Number
1384572|NCT01412957|Secondary|Progression Free Survival (PFS) in Participants With Wild-type RAS|"PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death.~Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date."|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
1384573|NCT01412957|Secondary|Overall Survival in Participants With Wild-type RAS|A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS)|||months||95% Confidence Interval|Median
1384574|NCT01412957|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT Analysis Set|||months||95% Confidence Interval|Median
1384575|NCT01412957|Primary|Overall Survival|Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol.|||months||95% Confidence Interval|Median
1384576|NCT01412944|Secondary|Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy|This outcome measure was not analyzed due to the small sample size of the study (43 participants).|End of study|||||||
1384577|NCT01412944|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant’s ability to respond to secukinumab treatment.|Baseline, weeks 12, 24 and 40|Participants from full analysis set (FAS), who had values at baseline and post-baseline, were included in the analysis. The FAS included all participants to whom treatment was assigned.|||Number of participants|||Number
1384578|NCT01412944|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||Percent change||Standard Deviation|Mean
1384579|NCT01412944|Secondary|Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percent change||Standard Deviation|Mean
1384602|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 12 Months.|Percentage of subjects with Readmission for cardiovascular events at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384580|NCT01412944|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percentage of participants|||Number
1384581|NCT01412944|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percentage of participants|||Number
1384582|NCT01412944|Secondary|Mean Percent Change From Baseline in PASI Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percent change||Standard Deviation|Mean
1384583|NCT01412944|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||Percentage of participants|||Number
1384584|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.|||Percentage of participants|||Number
1384585|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.|||Percentage of participants|||Number
1384586|NCT01412918|Secondary|Percentage of Participants Which Showed Presence of SCN9 Gene Expression.|Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.|Single visit (day 1), evaluated at the time of the genetic collection.||||% of participants with gene expression|||Number
1384587|NCT01412918|Primary|Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception|Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.|Single visit (day 1), assessed the day of visit||||percentage of participants|||Number
1384588|NCT01412879|Secondary|5-year Overall Survival (OS)|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|Up to 5 years|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1384589|NCT01412879|Secondary|Response Rate (Complete and Partial Response)|Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|Up to 9 months|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1384590|NCT01412879|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 8 months (Assessed at the beginning of each cycle of treatment, at restaging, and at post transplant.)|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1384591|NCT01412879|Primary|Progression-Free Survival (PFS) at 2 Years|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Up to 2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1384592|NCT01412801|Primary|Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.|The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).|||Ratios||95% Confidence Interval|Geometric Mean
1384593|NCT01412801|Secondary|Percentages of Infants Who Experienced Unsolicited Adverse Events|Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination|Birth to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Infants)|||percentages of Infant subjects|||Number
1384594|NCT01412801|Secondary|Percentages of Subjects Who Experienced Unsolicited Adverse Events|Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine|Day 1 to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Maternal Subjects)|||percentages of subjects|||Number
1384595|NCT01412801|Secondary|Percentages of Subjects With Solicited Systemic AEs|Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)|||percentages of Subjects|||Number
1384596|NCT01412801|Secondary|Percentages of Subjects With Solicited Local Adverse Events (AEs)|Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)|||percentage of Subjects|||Number
1384597|NCT01412801|Secondary|Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery|Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.|Day of Delivery|FAS (Maternal Subjects)|||Percentage of maternal subjects|||Number
1384598|NCT01412801|Secondary|Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery|Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.|Day 1, 15, 31 and at Delivery|FAS (Maternal Subjects in the Exposed Population) who -Secondary objective serum GMC: provided at least one evaluable sample result at day 1 (prior to vaccination), day 15, day 31, or at delivery;- Secondary objective kinetics: provided at least one evaluable serum sample at day 1 (prior to vaccination), day 15, day 31, and at delivery.|||µg/mL||95% Confidence Interval|Geometric Mean
1384599|NCT01412801|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth|GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).|||μg/mL||95% Confidence Interval|Geometric Mean
1384600|NCT01412710|Secondary|Glycemic Control|hemoglobin A1C blood test|Baseline|A1C baseline.|||Percentage of Hemoglobin||Standard Deviation|Mean
1384601|NCT01412710|Primary|Blood Lipid|Total cholesterol will be used as surrogate measures for cardiovascular disease risk.|Baseline|Total cholesterol baseline.|||mg/dl||Standard Deviation|Mean
1384603|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 6 Months.|Percentage of subjects with Readmission for cardiovascular events at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384604|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 1 Month.|Percentage of subjects with Readmission for cardiovascular events at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384605|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 12 Months.|Percentage of subjects with Major vascular complications at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384606|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 6 Months.|Percentage of subjects with Major vascular complications at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384607|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 1 Month.|Percentage of subjects with Major vascular complications at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384608|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 12 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384609|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 6 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384610|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1 Month.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384611|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 12 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384612|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 6 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384613|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 1 Month.|Percentage of subjects with Target Vessel Revascularization (TVR) at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384614|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 12 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participans||95% Confidence Interval|Number
1384615|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 6 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of partiipants||95% Confidence Interval|Number
1384616|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 1 Month.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384617|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 12 Months.|Percentage of subjects with All-cause death at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384618|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 6 Months.|Percentage of subjects with All-cause death at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384619|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 1 Month.|Percentage of subjects with All-cause death at 1 Month|1 month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384620|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 6 Months: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 6 months: index limb amputation, index limb re-intervention, and index-limb-related death.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of Participants||95% Confidence Interval|Number
1384972|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|The proportion (per cent) of the sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat|||Per cent||Standard Deviation|Geometric Mean
1384621|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 1 Month: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 1 Month.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 1 Month: index limb amputation, index limb re-intervention, and index-limb-related death at 1 month.|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of Participants||95% Confidence Interval|Number
1384622|NCT01412541|Secondary|Secondary Safety #1 - Percentage of Subjects With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint).|Percentage of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)|30 days|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384623|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical Component and Mental Component of SF-36 v2 From Baseline to 12 Months.|Mean change in quality of life physical component and mental component of SF-36 v2 from baseline to 12 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
1384624|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical and Mental Component of SF-36 v2 From Baseline to 6 Months.|Mean change in quality of life physical and mental component of SF-36 v2 from baseline to 6 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
1384625|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 12 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 12 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
1384626|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 6 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 6 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
1384627|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline Through 12 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline through 12 months|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||meters||Standard Deviation|Mean
1384628|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline to 6 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline to 6 months|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||meters||Standard Deviation|Mean
1384629|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 12 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 12 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
1384630|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 6 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 6 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 6 months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
1384631|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 12 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 12 months of resting ankle brachial index (ABI).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||ratio||Standard Deviation|Mean
1384632|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 6 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 6 months of resting ankle brachial index (ABI).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||ratio||Standard Deviation|Mean
1384633|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 12 Months.|Percentage of subjects with change of Rutherford classification from baseline to 12 months Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants improving|||Number
1384634|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 6 Months (%Improved).|"Percentage of subjects with change of Rutherford classification from baseline to 6 months (%Improved).~Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain"|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants improving|||Number
1384635|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 12 Months|12 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384636|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 6 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384637|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of partcipants||95% Confidence Interval|Number
1384638|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subject With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6 Months.|Percentage of subject with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384639|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.5 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.5 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384640|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Suplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <2.5 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Suplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <2.5 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384641|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <3.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <3.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384642|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <3.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <3.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384643|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384644|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound Peak Systolic Velocity Ratio (DUS PSVR) <2.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound peak systolic velocity ratio (DUS PSVR) <2.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|.The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384645|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency Rate at 12 Months (Defined by Core Lab Adjudication).|Percentage of subjects with Secondary Patency Rate at 12 Months (defined by core lab adjudication)|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384646|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency (Absence of Target Lesion Restenosis by Core Lab Adjudication) at 6 Months.|Percentage of subjects with Secondary Patency (absence of target lesion restenosis by core lab adjudication) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of Participants||95% Confidence Interval|Number
1384647|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 12 Months.|Percentage of subjects with duplex ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 12 months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384738|NCT01411228|Secondary|Liver Volume|Liver volume by MRI or Ultrasound. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||Milliliters||Standard Error|Mean
1384648|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 6 Months.|Percentage of subjects with Duplex Ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 6 months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
1384649|NCT01412541|Secondary|Secondary Efficacy #1B - Number of Subjects With Procedural Success.|Number of subjects with Procedural Success defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.|During the procedure|Based on number of subjects with Procedural success as identified by the core lab.|||participants|||Number
1384650|NCT01412541|Secondary|Secondary Efficacy #1A - Number of Subjects With Technical Success.|Number of subjects with Technical Success defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent.|During the procedure|Based on number of subjects with Technical success as identified by the core lab.|||participants|||Number
1384651|NCT01412541|Secondary|Secondary Efficacy #1 - Number of Devices With Device Success.|Number of devices with Device Success defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.|During the procedure|Based upon devices used in the study (432 for DCB and 180 for PTA).|||devices|Devices||Number
1384652|NCT01412541|Primary|Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year.|Percentage of subjects with Primary patency of the target lesion at one year. Primary patency is defined as freedom from target lesion restenosis (defined by duplex ultrasound core lab adjudication) and target lesion revascularization (TLR).|12 months|Overall, 83.5% (264/316) test DCB subjects and 84.4% (135/160) control PTA subjects were evaluable for the primary efficacy endpoint testing.|||percentage of participants||95% Confidence Interval|Number
1384653|NCT01412541|Primary|Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative (≤30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 12 Months.|Percentage of subjects with Composite of freedom from all-cause peri-operative (≤30 day) death and freedom from the following: index limb amputation, index limb re-intervention, and index-limb-related death at 12 months.|12 months|Overall, 90.5% (286/316) test DCB subjects and 89.4% (143/160) control PTA subjects were evaluable for primary safety endpoint testing.|||percentage of participants||95% Confidence Interval|Number
1384654|NCT01412424|Secondary|Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period|Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants|||Number
1384655|NCT01412424|Secondary|Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period|The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants||95% Confidence Interval|Number
1384656|NCT01412424|Secondary|Maintenance of Response During the Extension Treatment Period|Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration < 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants||95% Confidence Interval|Number
1384657|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 < 1.3 times the upper level of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Beginning and the end of the extension treatment period (up to 6 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants|||Number
1384676|NCT01412281|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects|||participants|||Number
1384658|NCT01412424|Secondary|Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period|Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)|Fixed dose population: All enrolled participants who received any amount of study drug, who had at least 1 IGF-1 or GH assessment after the first dose of octreotide, and who entered the fixed dose phase of the core treatment period.|||Percentage of participants|||Number
1384659|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 < 1.3 times the upper limit of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Baseline and the end of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.|||Percentage of participants|||Number
1384660|NCT01412424|Primary|Percentage of Responders at the End of the Extension Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of responders||95% Confidence Interval|Number
1384661|NCT01412424|Primary|Percentage of Responders at the End of the Core Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.|||Percentage of responders||95% Confidence Interval|Number
1384662|NCT01412333|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab|Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.|Baseline up to Week 96|Baseline evaluable participants with an ADA assay result from a baseline sample(s). The safety population included all participants who received any study drug. Here, n signifies the number of participants evaluable at the specified time points.|||participants|||Number
1384663|NCT01412333|Secondary|Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)|AUC represents total drug exposure for one dosing interval after the 4th dose.|Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96|The pharmacokinetics (PK) population included all participants in the ocrelizumab group who had at least 1 measurable concentration value.|||micrograms per milliter*day||Standard Deviation|Mean
1384664|NCT01412333|Secondary|Number of Participants With Adverse Events (AEs)|AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.|Baseline up to Week 96|The safety population included all participants who received any study drug.|||participants|||Number
1384665|NCT01412333|Secondary|Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96|NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analysed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1384666|NCT01412333|Secondary|Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Baseline, Week 96|Descriptive statistics at baseline include participants with assessment at baseline and at least one post- baseline value. ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||t-score||Standard Error|Mean
1384667|NCT01412333|Secondary|Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96|Brain volume was recorded as an absolute “normalized” value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).|From week 24 up to week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percent change||Standard Error|Mean
1384668|NCT01412333|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96|MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.|Baseline, Week 96|ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||Z-score||Standard Error|Mean
1384669|NCT01412333|Secondary|Number of T1 Hypointense Lesions During the Double-Blind Treatment|The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.|||lesions|||Number
1384670|NCT01412333|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 104|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
1384671|NCT01412333|Secondary|Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks|Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1384672|NCT01412333|Secondary|Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment|The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.|||lesions|||Number
1384673|NCT01412333|Secondary|Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment|The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.|||lesions|||Number
1384674|NCT01412333|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 104|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
1384675|NCT01412333|Primary|Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks|ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.|Week 96|Intent-to-treat (ITT) population included all randomized participants in the study.|||relapses/participant year of treatment||95% Confidence Interval|Number
1397986|NCT01283321|Secondary|Volume (mL) of Fresh-frozen Plasma (FFP) Transfused-during Surgery and up to 24 Hours After Surgery||Operative period up to 60 minutes and up to 24 hours after surgery||||ml||Inter-Quartile Range|Median
1384677|NCT01412281|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage of seroconverted subjects||95% Confidence Interval|Number
1384678|NCT01412281|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of seroprotected subjects||95% Confidence Interval|Number
1384679|NCT01412281|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase from baseline||95% Confidence Interval|Number
1384680|NCT01412229|Secondary|Patient-reported Quality of Life Scores|Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) is the FACT-G and a 12 item head and neck cancer specific subscale completed at screening (Screening), 3 weeks post induction chemotherapy (Treatment Break), 7 weeks post concomitant chemoradiotherapy (7 weeks Off Treatment), one year post off-treatment (1 year Off Treatment). The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4 (resulting in potential total scores between 0 and 156). Higher scores represent better QOL.|screening until one year after treatment|All patients on treatment who returned completed questionnaires at each time point|||FACT-HN score||Full Range|Median
1384681|NCT01412229|Secondary|Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event|Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.|24 Weeks|Patients who received study treatment|||participants|||Number
1384682|NCT01412229|Secondary|Number of Participants With at Least One Grade 3-4 Toxicity|Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.|9 Weeks|Patients who received treatment on study|||Participants|||Count of Participants
1384683|NCT01412229|Secondary|Overall Survival|Rate of Overall Survival|1 year|Patients who completed treatment|||Participants|||Count of Participants
1384684|NCT01412229|Secondary|Complete Response Rate (CR)|Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation|20 weeks|Patients who completed treatment|||Participants|||Count of Participants
1384685|NCT01412229|Secondary|Objective Response Rate (CR+PR)|Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|20 weeks|Patients who completed treatment|||Participants|||Count of Participants
1384686|NCT01412229|Secondary|Progression Free Survival|Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for one year)|1 year||||percentage of participants||95% Confidence Interval|Number
1384687|NCT01412229|Secondary|Rate of Complete Response Following Induction Chemotherapy|Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.|Baseline evaluation to 3 weeks after induction chemotherapy||||Participants|||Count of Participants
1384688|NCT01412229|Primary|Clinical Response Rate Following Induction Chemotherapy|Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|9 weeks||||Participants|||Count of Participants
1384689|NCT01412164|Secondary|Stent Implantation Success Rate|30 days, 6 months, and 2-5 years TLF, cardiovascular composite endpoints, ARC defined stent thrombosis|5 years|||||||
1384690|NCT01412164|Primary|Device Related Cardiovascular Composite Endpoint|Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure|12 months||||participants|||Number
1384691|NCT01412151|Secondary|Biological Markers of Disease Progression|Biological indicators that creatine treatment might affect the progression of HD: serum creatine levels, neuroimaging, metabolomic and gene expression analysis|310 Weeks|data was not collected or analyzed for this outcome measure.||||||
1384692|NCT01412151|Secondary|Clinical Measures Resources Not Available to Complete Secondary Analyses.|"Components of the UHDRS (Unified Huntington Disease Rating Scale)~data was not collected or analyzed for this outcome measure."|310 Weeks|data was not collected or analyzed for this outcome measure.||||||
1384693|NCT01412151|Primary|Tolerability|Proportion of subjects able to complete treatment|306 Weeks||||Participants|||Number
1384706|NCT01411852|Secondary|Ventilator Free Days Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of the 911 call through Day 28|Patients with known discharge status.|||Ventilator-free days||Standard Deviation|Mean
1384973|NCT01409837|Primary|Total Sperm Cell Count|The total number of sperm cells found in each milliliter of seminal fluid.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.|||Millions/ml||Standard Deviation|Geometric Mean
1384694|NCT01412086|Primary|Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.|||Kappa statistics||95% Confidence Interval|Number
1384695|NCT01412086|Primary|Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters scored 112 subjects’ eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kendall’s W was provided.|Day 1||||Kendall's W||95% Confidence Interval|Number
1384696|NCT01412060|Primary|Time From Baseline to the First Symptom Relapse During the Double-blind Phase|"Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored <50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of >4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion.~PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant’s illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported."|Up to 34 Weeks and Bi-Weekly thereafter until Week 92|Double-blind intent-to-treat population: All participants who received at least 1 dose of double-blind investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the Double-blind Treatment Phase.|||Days||95% Confidence Interval|Number
1384697|NCT01411995|Primary|Pain Score Assessed Immediately Following IUD Insertion|"Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required.~Range: 0-10 (0= no pain, 10=worst pain)"|Immediately following IUD insertion||||units on visual analog scale||Full Range|Median
1384698|NCT01411891|Primary|Femoral Nerve Catheter Bacterial Colonization|Describes rate of femoral nerve catheter bacterial colonization.|Colonization measured following catheter removal (approximately 48 hours after placement).|Patients presenting for elective TKA.|||participants|||Number
1384699|NCT01411891|Secondary|Catheter Insertion Site Colonization.|Skin at the FNC insertion site will be swabbed with a sterile cotton tip applicator moistened with sterile normal saline. The swab will be placed in a sterile container. The swab will be inoculated onto a blood agar plate/eosin-methylene blue plate/chocolate agar plate and incubated for 3 days aerobically, then inoculated onto an anaerobic brucella-agar plate and incubated for 7 days anaerobically. Bacterial growth found in the first quadrant of the inoculated plate will be defined as low grade, in the second and/or third will be moderate, and in the fourth quadrant will be heavy.|24-48 hours.|||||||
1384700|NCT01411891|Primary|Catheter Tip Colonization|Three cm of the for research purposes only, a 3 cm distal portion will be cut using sterile scissors into a sterile container, and sent to the lab for culture in a sterile container. The catheter segments will be rolled onto blood agar plates at 35°C under aerobic and anaerobic conditions. Number of colonies will be counted at 1 week. The peripheral nerve catheter tip will be considered colonized if the culture yields 15 or greater colony forming units.|24-48 hours after placement of femoral nerve catheter.|||||||
1384701|NCT01411852|Secondary|In-hospital Mortality|Number of patients who died prior to discharge.|From day of the 911 call through hospital discharge|All enrolled patients|||participants|||Number
1384702|NCT01411852|Secondary|Penetrating Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by penetrating mechanisms in each arm.|From time of hospital arrival through first 24 hours|Patients with traumatic shock due to penetrating traumatic mechanisms|||participants|||Number
1384703|NCT01411852|Secondary|Blunt Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by blunt mechanisms in each arm.|From time of hospital arrival through first 24 hours|Analyzed patients had traumatic shock due to blunt traumatic mechanisms. One patient randomized to the controlled resuscitation group was not analyzed because neither blunt force nor penetrating injury had occurred. It was determined that the source of bleeding was from a gastrointestinal lesion.|||participants|||Number
1384704|NCT01411852|Secondary|Days Alive Out of the Hospital Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the hospital"|From day of the 911 call through Day 28|Patients with known discharge status|||Days alive out of hospital thru day 28||Standard Deviation|Mean
1384705|NCT01411852|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the intensive care unit"|From day of the 911 call through Day 28|Patients with known discharge status|||ICU-free days||Standard Deviation|Mean
1397987|NCT01283321|Secondary|Number of Participants in Whom Transfusion of Platelet Concentrate is Required During or After Surgery.||Operative period up to 60 minutes||||Participants|||Count of Participants
1384707|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Failure Without Glomerular Filtration Rate (GFR)"|Increased plasma creatinine > 3 x reference measure (ED admission) or acute plasma creatinine = 350 umol/L or acute rise = 44 umol/L or urine output < 0.3 mL/k/h x 24h. Only measured for patients with at least 2 days of ICU stay assessed.|From ED arrival through the first 24 hours|Patients with at least at 2 day stay in the ICU|||participants|||Number
1384708|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Injury Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 2 x reference measure (ED admission) or urine output < 0.5 mL/kg/h x 24h. The RIFLE urine criterion for this level actually specifies a 12 hour period of assessment but study data are collected for 24-hr periods. This row includes patients who met the Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least at 2 day stay in the ICU|||participants|||Number
1384709|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Risk Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 1.5 x reference measure (ED admission). Urine criteria is based on 6-hour periods for this level of the RIFLE and cannot be assessed since study data are collected for 24-hour periods. This row includes patients who met the Injury and Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least a 2 day ICU stay|||participants|||Number
1384710|NCT01411852|Secondary|Hemorrhage Control Procedure Within 2 Hours of ED Arrival|Hemorrhage control procedures include blood vessel ligated or embolized, organ packed or removed, laparotomy or thoracotomy|From ED arrival through the first 2 hours|All patients except for 1 patient who was enrolled while in police custody|||participants|||Number
1384711|NCT01411852|Secondary|International Normalized Ratio (INR) on Admission to the Emergency Department|The first International normalized ratio (INR) value reported from blood drawn within the first 24 hours from arrival|From final Emergency Department arrival time through first 24 hours|Patients who had a first INR value measured within the first 24 hours of ED arrival|||ratio||Standard Deviation|Mean
1384712|NCT01411852|Secondary|Platelet Value on Admission|First platelet value from blood drawn in the the first 24 hours after arrival|From final Emergency Department arrival time through first 24 hours|All patients with the first platelet value measured within the first 24 hours of ED arrival|||10^9 Platelets/Liters||Standard Deviation|Mean
1384713|NCT01411852|Secondary|Hemoglobin on Admission to the Emergency Department|The first hemoglobin value reported from blood drawn in the final Emergency Department|From final Emergency Department arrival time through first 24 hours|All patients with a first hemoglobin measured within the first 24 hours of ED arrival|||grams/deciliter||Standard Deviation|Mean
1384714|NCT01411852|Secondary|Base Deficit on Admission to the Emergency Department (ED)|The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal.|From final Emergency Department arrival time through first 24 hours|Patient with the first base deficit recorded in the first 24 hours of the ED arrival|||mmol/Liter||Standard Deviation|Mean
1384715|NCT01411852|Secondary|Total Blood Product Requirements in First 24 Hours|Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo)|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody|||Liters||Standard Deviation|Mean
1384716|NCT01411852|Secondary|Total Fluid Requirement During First 24 Hours|Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody|||Liters||Standard Deviation|Mean
1384717|NCT01411852|Secondary|Number of Ineligible Patients Enrolled at the Time of Randomization|"Eligibility criteria:~Inclusion Criteria~Included will be those with:~Blunt or penetrating injury~Age ≥15yrs or weight ≥50kg if age is unknown~Prehospital SBP ≤ 90 mmHg 5.3 Exclusion Criteria~Excluded will be those with:~Ground level falls~Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8~Bilateral paralysis secondary to suspected spinal cord injury~Fluid greater than 250 ml was given prior to randomization~Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization~Known prisoners~Known or suspected pregnancy~Drowning or asphyxia due to hanging~Burns Total Body Surface Area (TBSA) > 20%~Time of call received at dispatch to study intervention > 4 hours"|From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival|All patients enrolled in the study.|||participants|||Number
1384718|NCT01411852|Primary|24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients each arm|From time of hospital arrival through the first 24 hours|All patients except for one who was enrolled while in police custody|||participants|||Number
1384719|NCT01411852|Primary|Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility)|The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period|From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first|Patients with traumatic shock due to blunt or penetrating mechanisms|||liters||95% Confidence Interval|Mean
1384720|NCT01411839|Secondary|MedSignals Electronic Pill-box for Adherence|The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.|6 and 9 month follow-up adherence scores||||Percent adherence||Standard Deviation|Mean
1384721|NCT01411839|Secondary|Self-Report Adherence|Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence.|Self-reported adherence at 6 and 9-month follow-up||||Percent of all doses of medication taken||Standard Deviation|Mean
1384722|NCT01411839|Primary|Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a|"Clinician-administered ratings are scored on the MADRS. The MADRS is a 10-item, past 7-day clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The areas are: apparent and reported sadness, inner tension, reduced sleep/appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.~Participant self-report ratings are scored on the BDI-1a. The BDI-1a is assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. The MADRS and BDI-Ia is scored a total units on the scale."|MADRS and BDI-1a scores at 6 and 9-month follow-up||||Units on a scale||Standard Deviation|Mean
1384723|NCT01411774|Secondary|Clinical Global Impression-Severity|The Clinical Global Impression-Severity involves a trained clinician rating how severe the person's OCD symptoms are on a 0 to 6 scale, with higher scores corresponding to more severe symptoms. This rating only involves a clinician completing a single item.|10 weeks||||units on a scale||95% Confidence Interval|Mean
1384724|NCT01411774|Primary|Children's Yale-Brown Obsessive-Compulsive Scale.|The Children's Yale-Brown Obsessive-Compulsive Scale measures the severity of OCD symptoms. There are 10 questions that are summed to arrive at a total score, with higher scores representing more severe OCD symptoms (scores range from 0-40).|10 weeks||||units on a scale||95% Confidence Interval|Mean
1384725|NCT01411696|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.|Baseline, 4 to 20 Weeks after Each injection (up to 6 months)|All participants with data available for analysis.|||Micron (μm)||Standard Deviation|Mean
1384726|NCT01411696|Secondary|Percentage of Participants With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.|||Percentage of participants|||Number
1384727|NCT01411696|Secondary|Percentage of Participants With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.|||Percentage of participants|||Number
1384728|NCT01411696|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 4 to 20 weeks after last injection (Up to 6 months)|All participants with data available for analysis.|||Lines||Full Range|Mean
1384729|NCT01411592|Secondary|Debonding of the RBFDP|Restoration was rebonded without any impairment of function|5 years||||participants|||Number
1384730|NCT01411592|Primary|Final Loss of the Restauration||5 years||||participants|||Number
1384731|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 8th Week|"This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3.~0—Without difficulty~Defecation straining~Severe defecation straining~Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.~[the average score of one week at the 8th week]-[the average score of one week at baseline]"|baseline and at 8 weeks||||participants|||Number
1384732|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 8th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.|baseline and at 8 weeks||||units on a scale||Full Range|Mean
1384733|NCT01411501|Secondary|Changes of the SBMs From Baseline at Week 8|[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 8 weeks||||times per week||95% Confidence Interval|Mean
1384734|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 4th Week|"This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3.~0—Without difficulty~Defecation straining~Severe defecation straining~Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.~[the average score of one week at the 4th week]-[the average score of one week at baseline]"|baseline and at 4 weeks||||participants|||Number
1384735|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 4th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.|baseline and at 4 weeks||||units on a scale||95% Confidence Interval|Mean
1384736|NCT01411501|Primary|Change of the SBMs From Baseline at Week 4|[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 4 weeks||||times per week||95% Confidence Interval|Mean
1384737|NCT01411488|Primary|Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS|anal erosion within 14 days after insertion of FMS|up to 14 days|Pearson's chi square test (categorical data) and Wilcoxon test (continuous measures). Logistic regression was used to assess primary endpoint by time the device was in use.|||Participants|||Count of Participants
1384739|NCT01411228|Secondary|Platelet Count|Platelet count. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12, 24 and 33-36|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||Platelets/mm^3||Standard Error|Mean
1384740|NCT01411228|Secondary|Spleen Volume|Spleen volume measured by MRI (or ultrasound). Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||Milliliters||Standard Error|Mean
1384741|NCT01411228|Secondary|Chitotriosidase|Chitotriosidase. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Chitotriosidase was not analyzed for the subjects in the Switchover group|||nmol/mL*h||Standard Deviation|Mean
1384742|NCT01411228|Primary|Hemoglobin|Median and interquartile range. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||g/dL||Inter-Quartile Range|Median
1384743|NCT01411215|Secondary|Number of RA Participants Had Remission of Disease|Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.|||Participants|||Number
1384744|NCT01411215|Secondary|Number of RA Participants Had DAS28-4 (ESR) Improvement|Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2.|Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR) improvement. n=number of evaluable participants at the corresponding visit.|||Participants|||Number
1384745|NCT01411215|Secondary|Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity.|Baseline (Week 0), Week 2, Week 4, Week 12, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.|||units on a scale||Standard Deviation|Mean
1384746|NCT01411215|Secondary|Swollen Joint Count (SJC) for RA Participants|SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for SJC. n=number of evaluable participants at the corresponding visit.|||Joints||Standard Deviation|Mean
1384747|NCT01411215|Secondary|Tender Joint Count (TJC) for RA Participants|TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for TJC. n=number of evaluable participants at the corresponding visit.|||Joints||Standard Deviation|Mean
1384748|NCT01411215|Secondary|Number of Participants With Any Abnormal Laboratory Test Results|Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN).|Baseline (Week 0) up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for laboratory test abnormalities.|||Participants|||Number
1384749|NCT01411215|Secondary|Evaluate the Association Between Participant's Age and Treatment Adherence Rate|Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded. n=number of evaluable participants at the corresponding age group.|||Participants|||Number
1384782|NCT01410474|Secondary|Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and Day 29|Analysis was done on MITT population|||Ratio||95% Confidence Interval|Geometric Mean
1384750|NCT01411215|Secondary|Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%|Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded.|||Participants|||Number
1384751|NCT01411215|Secondary|VAS Score for Pain|Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for pain. n=number of evaluable participants at the corresponding visit.|||mm||Standard Deviation|Mean
1384752|NCT01411215|Secondary|Participant’s Global Assessment (PtGA) of Disease Activity|Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for PtGA of disease activity. n=number of evaluable participants at the corresponding visit.|||mm||Standard Deviation|Mean
1384753|NCT01411215|Secondary|Physician’s Global Assessment of Disease Activity|Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant’s disease according to the participant’s clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for physician’s global assessment of disease activity. n=number of evaluable participants at the corresponding visit.|||mm||Standard Deviation|Mean
1384754|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
1384755|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
1384756|NCT01411215|Primary|Number of Participants Who Had Any SAEs During 52 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
1384757|NCT01411215|Primary|Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
1384758|NCT01411215|Primary|Number of Participants Who Had Any AEs During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
1384759|NCT01411215|Primary|Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
1384760|NCT01411137|Primary|Parkinson’s Disease Questionnaire-8 (PDQ-8)|Change from Baseline in Parkinson's disease Questionnaire-8 (PDQ-8) at End of Study or early discontinuation. The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).|6 months||||units on a scale||Standard Deviation|Mean
1384761|NCT01411137|Primary|Clinical Global Impression (CGI)|"Clinician-reported satisfaction outcome of IPX066 using Clinical Global Impression (PGI) 7-point scale.~At Part 1 Week 6; Part 2 Month 3, and Month 6 or at Early Termination, the Investigator rated how much a subject’s overall condition had changed since Part 1 Visit 1 (Baseline) using 7-point scale. 1=very much worse and 7=very much improved."|6 months||||units on a scale||Standard Deviation|Mean
1384762|NCT01411137|Primary|Patient Global Impression (PGI)|At Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.|6 months||||units on a scale||Standard Deviation|Mean
1384783|NCT01410474|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and 29|Analysis was done on MITT population|||hSBA Titers||95% Confidence Interval|Geometric Mean
1384763|NCT01411085|Primary|Timeline Followback Assessing Number of Drinks Per Week|Alcohol/other substance use (including tobacco) will be assessed primarily by weekly self-report using the Timeline Followback (TLFB) method enhanced by procedures to strengthen the reliability and validity of this measure. It involves asking participants to retrospectively estimate their alcohol and other substance use.|Weekly for 14 weeks, using data from last 8 weeks|The analysis was performed on all completers (N=7).|||Drinks per week||Standard Deviation|Mean
1384764|NCT01410773|Secondary|Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the YSI capillary plasma reference method results.|1 hour|One subject had low blood sugar. The protocol (and User Guide) do not allow alternative site testing when blood sugar is low. The remaining 109 subjects tested one strip lot on the BGM system. 109 test results were available.|||participants|||Number
1384765|NCT01410773|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|110 subjects tested one of 3 test strip lots on the BGM system. 110 (1x110) test results are available.|||participants|||Number
1384766|NCT01410604|Secondary|Waist Circumference|Change from baseline in Waist circumference after 3 months of treatment.|baseline and 3 months||||cm||Standard Deviation|Mean
1384767|NCT01410604|Secondary|Body Mass Index|Change from baseline in Body Mass Index after 3 months of treatment.|baseline and 3 months||||kg/m^2||Standard Deviation|Mean
1384768|NCT01410604|Secondary|Fasting Insulin|Change from baseline in Fasting insulin after 3 months of treatment.|baseline and 3 months||||µU/mL||Standard Deviation|Mean
1384769|NCT01410604|Secondary|Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose after 3 months of treatment.|baseline and 3 months||||mg/dL||Standard Deviation|Mean
1384770|NCT01410604|Primary|Tumour Necrosis Factor Alpha|Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.|baseline and 3 months||||pg/mL||Standard Deviation|Mean
1384771|NCT01410604|Primary|Interleukin 6|Change from baseline in Interleukin 6 after 3 months of treatment.|baseline and 3 months||||pg/mL||Standard Deviation|Mean
1384772|NCT01410604|Primary|High-sensitivity C-reactive Protein|Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.|baseline and 3 months||||mg/dL||Standard Deviation|Mean
1384773|NCT01410604|Primary|Adiponectin|Change from baseline in Adiponectin after 3 months of treatment.|baseline and 3 months||||µg/mL||Standard Deviation|Mean
1384774|NCT01410565|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.|24 Months from Randomization|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.|||participants|||Number
1384775|NCT01410565|Secondary|Recurrence Rate at 24 Months|Measurement the number of participants with the recurrence at 24 months.|24 months|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.|||participants|||Number
1384776|NCT01410565|Primary|Time to Recurrence|Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).|Recurrence of cancer in the bladder during 24 months of follow-up|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase. Participants without recurrence were censored.|||months||Full Range|Mean
1384777|NCT01410552|Secondary|Shock(s) Appropriately Delivered|Percentage of shocks appropriately delivered|552 days||||Percentage of appropriate shocks|||Number
1384778|NCT01410552|Primary|Patients With Inappropriate Shock(s)|Percentage of patients presenting with inappropriate shock(s)|552 days||||Percentage of pts with inap shocks|||Number
1384779|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years|Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population.|||Subjects|||Number
1384780|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years|Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.|||Subjects|||Number
1384781|NCT01410474|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.|Day 1 and 29|Analysis was done on MITT population|||Percentages of Subjects||95% Confidence Interval|Number
1384974|NCT01409837|Primary|Ejaculate Volume|The volume in milliliters of seminal fluid produced per ejaculation.|Week 282|All the patients who were randomized into eacg group was analyzed on the basis of intention-to-treat|||ml||Standard Deviation|Geometric Mean
1384784|NCT01410474|Secondary|Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups.~Seroresponse is defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on MITT population|||Percentages of Subjects||95% Confidence Interval|Number
1384785|NCT01410474|Primary|Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29).~Seroresponse is defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.|||Percentages of Subjects||95% Confidence Interval|Number
1384786|NCT01410448|Secondary|Percentage of Participants With a New Onset of Diabetes|The percentage of participants with a new onset of diabetes was assessed.|12 months|Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||Percentage of participants|||Number
1384787|NCT01410448|Secondary|Percentage of Participants With a New Onset of Malignancy|The percentage of participants with a new onset of malignancy was assessed.|12 months|Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||Percentage of participants|||Number
1384788|NCT01410448|Secondary|Percentage of Participants With Acute Rejection (AR)|AR was defined as an episode of increased serum creatinine >30% that was clinically diagnosed as an acute rejection but was not biopsy proven.|12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384789|NCT01410448|Secondary|Percentage of Participants With Proteinuria|Incidence of proteinuria (>1,000 mg/day in urine collected in 24 hours or > 1.0 if measured on the urine protein/creatinine concentration ratio in a spot urine sample) was assessed.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384790|NCT01410448|Secondary|Change From Baseline in Serum Creatinine - Modified ITT|Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.|baseline, 12 months|Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||mg/dL||Standard Deviation|Mean
1384791|NCT01410448|Secondary|Change From Baseline in Serum Creatinine - ITT|Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.|baseline, 3 months|Participants from the ITT, who had both baseline and the post-baseline measurement for a given post-baseline time point, were included in the analysis for that post-baseline time point. The ITT population included all randomized participants who were treated.|||mg/dL||Standard Deviation|Mean
1384792|NCT01410448|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT|Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.|baseline, 12 months|Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||mL/min||Standard Deviation|Mean
1384793|NCT01410448|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT|Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.|baseline, 3 Months|Participants from the ITT, who had both baseline and month 3 measurements, were included in the analysis for the month 3 time point. The ITT population included all randomized participants who were treated.|||mL/min||Standard Deviation|Mean
1384794|NCT01410448|Secondary|Duration of DGF|The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis.|3 months|Participants from the Intent-to-Treat (ITT) populations who required dialysis, 46 (23.83%) of the IE group and 60 (31.58%) of the DE group, were analyzed. The ITT population included all randomized participants who were treated.|||Days||Full Range|Median
1384795|NCT01410448|Secondary|Percentage of Participants With Delayed Graft Function (DGF) -|DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation.|3 Months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384810|NCT01410409|Secondary|Change in EQ-5D From Baseline|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description (Links)~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
1384796|NCT01410448|Secondary|Percentage of Participants With BPAR - Worst-case Scenario|A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason.|3 Months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384797|NCT01410448|Secondary|Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario|The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason.|3 months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384798|NCT01410448|Secondary|Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario|The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384799|NCT01410448|Secondary|Patient Survival Rate: Percentage of Deaths - Worst-case Scenario|The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason.|3 Months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384800|NCT01410448|Secondary|Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario|The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
1384801|NCT01410448|Secondary|Percentage of Participants Without Wound Healing Complications - Worst-case Scenario|The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit.|12 months|The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.|||Percentage of participants|||Number
1384802|NCT01410448|Primary|Percentage of Participants Without Wound Healing Complications - Worst-case Scenario|The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.|3 months|The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.|||Percentage of participants|||Number
1384803|NCT01410409|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.~Number of sites with pain in the previous 24 hours shaded on a region-divided body chart~Pain location and type assessed using the Knee Pain Map.~Maximum isometric muscle strength (converted to Nm using the length of the lower leg) measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander from JTech Medical Industries, Salt Lake City, Utah, USA)~Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at five sites at the knee and the m. tibialis anterior muscle.~Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.~Further exploratory objectives may be added later on."|Baseline, 3months, 6months, 12months and 24 months.|Will be reported in later publications, as it is exploratory outcomes||||||
1384804|NCT01410409|Secondary|Serious Adverse Events Related to the Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants|Primary: 12months||||Serious adverse events related to knee|||Number
1384805|NCT01410409|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.||||proportion of participants||95% Confidence Interval|Number
1384806|NCT01410409|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in the analysis|||kg||95% Confidence Interval|Mean
1384807|NCT01410409|Secondary|Change in the Five Subscales of KOOS From Baseline|All subscales going from 0 to 100 (worst to best)|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
1384808|NCT01410409|Secondary|Change in 20-meter Walk From Baseline||Primary: 12months.||||sec||95% Confidence Interval|Mean
1384809|NCT01410409|Secondary|Change in Timed Up & Go (TUG) From Baseline||Primary: 12months.||||sec||95% Confidence Interval|Mean
1384873|NCT01410240|Secondary|Amount of FLOSEAL Applied||Intra-operatively (Day 0)|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 15 Run-In participants"|||mL||Standard Deviation|Mean
1384811|NCT01410409|Primary|Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)|The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
1384812|NCT01410357|Other Pre-specified|Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks|The Perceived Mental Health Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to mental health.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
1384813|NCT01410357|Other Pre-specified|Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks|The Perceived Diabetes Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Items 1, 2, 6, and 7 are reverse coded. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to diabetes.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 67 TTIM and 72 TAU.|||scores on a scale||Standard Deviation|Mean
1384814|NCT01410357|Other Pre-specified|Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks|The Multidimensional Scale of Perceived Social Support is a 12 question Likert scale, with each item ranging from 1-5. Total scores range from 12-60, with higher scores indicating more perceived social support.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
1384815|NCT01410357|Other Pre-specified|Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks|The diabetes knowledge score has 23 questions which assess how much knowledge one has about diabetes. They are in multiple choice format, with 4 choices, and only one is correct. The total amount correct is added up, and then calculated into a percentage of answers correct.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.|||percent correct||Standard Deviation|Mean
1384816|NCT01410357|Other Pre-specified|Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks|The Utilization of Mental Hospital score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.|||time utilized||Standard Deviation|Mean
1384817|NCT01410357|Other Pre-specified|Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks|The Utilization of Mental Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 76 completed TAU, there was some missing data for this scale, resulting in 74 TAU.|||times utilized||Standard Deviation|Mean
1384818|NCT01410357|Other Pre-specified|Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks|The Utilization of Physical Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 74 TTIM and 75 TAU.|||times utilized||Standard Deviation|Mean
1384819|NCT01410357|Secondary|Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stigma Resistance, has 5 Likert-scale items. Each question is rated as 0= strongly disagree, 1= disagree, 2= neutral, 3= agree, 4= strongly agree. These scores are all reverse coded. Total scores on the Stigma Resistance subscale range from 0-20, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
1384820|NCT01410357|Secondary|Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Social Withdrawal, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Social Withdrawal subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
1384821|NCT01410357|Secondary|Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Discrimination Experience, has 5 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Discrimination Experience subscale range from 5-25, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
1384874|NCT01410240|Secondary|Total Tourniquet Time|Measured from the time point of the tourniquet inflation to deflation using the same watch/clock|Intra-operatively (on day of surgery = Day 0)|Full Analysis Set|||minutes||Standard Deviation|Mean
1384875|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 3||Pre-operative and day 3 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."|||percent||Standard Deviation|Mean
1384822|NCT01410357|Secondary|Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stereotype Endorsement, has 7 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores on the Stereotype Endorsement subscale range from 7-28, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
1384823|NCT01410357|Secondary|Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Alienation, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Alienation subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
1384824|NCT01410357|Secondary|Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks|The AUDIT scale (Alcohol Use Disorders Identification Test) has 10 questions, with scores on each question ranging from 0 to 4 (0= never, 1= less than monthly, 2= monthly, 3= weekly 4= daily/almost daily). Questions 9 and 10 only have three anchors: 0, 2, and 4. The scores are summed to get total. Therefore, the range of possible scores are 0-40, with higher scores indicating indicating a greater likelihood of hazardous and harmful drinking. However, such scores may also reflect greater severity of alcohol problems and dependence, as well as a greater need for more intensive treatment.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 73 TAU.|||Scores on a scale||Standard Deviation|Mean
1384825|NCT01410357|Secondary|Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks|The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. It is comprised of 10 questions, to which each have a 5 point scale with anchors 1= never through 5= always. The items are summed to a total score, which ranges from 10-50.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384826|NCT01410357|Secondary|Tablets Routine Questionnaire (TRQ) at 60 Weeks|The self-reported Tablets Routine Questionnaire (TRQ) measures change in treatment adherence. The TRQ determines proportion of prescribed medication missed, and ranges from 0 (no medication missed/100% adherent) to 100 (no medication taken/0% adherent). The TRQ format captured an exact proportion (%) of days with a missed medication dose for each oral maintenance psychotropic medication and then an average combined TRQ was calculated for all orally-prescribed medications.|60 weeks||||percentage of days adherent||Standard Deviation|Mean
1384827|NCT01410357|Primary|SF-36 Health Survey at 60 Weeks; Physical Health Component|The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384828|NCT01410357|Primary|Body Mass Index (BMI) at 60 Weeks||60 weeks||||kg/m^2||Standard Deviation|Mean
1384829|NCT01410357|Primary|Systolic Blood Pressure at 60 Weeks||60 weeks||||mmHg||Standard Deviation|Mean
1384830|NCT01410357|Primary|Glycosylated Hemoglobin (HbA1c) at 60 Weeks||60 weeks||||mmol/mol||Standard Deviation|Mean
1384831|NCT01410357|Primary|SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component|The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384832|NCT01410357|Primary|Sheehan Disability Scale (SDS) at 60 Weeks|The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384833|NCT01410357|Primary|Global Assessment of Functioning (GAF) at 60 Weeks|The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384834|NCT01410357|Primary|Clinical Global Impression (CGI) at 60 Weeks|The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384835|NCT01410357|Primary|Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks|The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384836|NCT01410357|Primary|Brief Psychiatric Rating Scale (BPRS) at 60 Weeks|The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.|60 weeks||||scores on a scale||Standard Deviation|Mean
1384837|NCT01410344|Secondary|Hematologic Function|Hematologic function will be defined by absolute neutrophil count (ANC) greater than 1500, Hemoglobin greater than 10g/dL without transfusion support, and platelets greater than 100,000 and measured at Day 100 and 6 months. Use of growth factors will be noted.|Day 100, 6 months||2018-12-31|12/2018||||
1384838|NCT01410344|Secondary|Impact of Therapy on the HIV Reservoir|HIV-1 RNA in plasma will be measured by standard real-time reverse transcription polymerase chain reaction (RT-PCR) (detection limit 40 copies/ml) and by the investigational single copy assay (SCA, detection limit 0.38 copy/ml). HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) and other cells will be quantified using the same primers and probes used for SCA but without a reverse transcription step. HIV-1 RNA levels will be measured in plasma prior to the initiation of ablative chemotherapy, and at Day +100, 1 and 2 years post-transplant.|Day 100, 6 Months, 12 Months, and 24 Months||2018-12-31|12/2018||||
1384839|NCT01410344|Secondary|Immunologic Reconstitution|This will be measured in all patients at 8 weeks, 6 months, 12 months and 24 months post-transplant. Tests to be performed on peripheral blood at those time points include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-, and quantitative immunoglobulins (IgM, IgG and IgA).|8 Weeks; 6, 12 and 24 Months||2018-12-31|12/2018||||
1384840|NCT01410344|Secondary|Chronic Graft-versus-Host Disease (GVHD)|Chronic GVHD will be scored according to the BMT CTN Manual of Procedures. The time to onset of limited and extensive chronic GVHD will be recorded.|100 days, 6 months, 2 years||2018-12-31|12/2018||||
1384841|NCT01410344|Secondary|Acute Graft-versus-Host Disease (GVHD)|Acute GVHD will be graded according to the BMT CTN Manual of Procedures. The time to onset of acute grades II-IV GVHD and grades III-IV GVHD will be recorded, as well as the maximum grade achieved.|100 Days||2018-12-31|12/2018||||
1384842|NCT01410344|Secondary|Six Month Overall Survival|Overall survival is defined as time from transplant to death or last follow-up.|Six months post transplant||2018-12-31|12/2018||||
1384843|NCT01410344|Secondary|Incidence of Infections|Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any.|Date of transplant through one year post-transplant||2018-12-31|12/2018||||
1384844|NCT01410344|Secondary|Chimerism|Blood samples will be evaluated for T cell and myeloid chimerism at 4 weeks, 100 days and 6 months post-transplant.|4 weeks, 100 days and 6 months||2018-12-31|12/2018||||
1384845|NCT01410344|Secondary|Disease Status Following Transplant|Patients will be assessed for disease status at Day 100 post-HCT: complete remission, partial remission (HL, NHL), stable disease (HL, NHL), relapse.|100 days||2018-12-31|12/2018||||
1384846|NCT01410344|Primary|Percentage of Participants With Non-Relapse Mortality|The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy.|100 days post-transplant||||percentage of participants|||Number
1384847|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384848|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384849|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384850|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384851|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384852|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384853|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384854|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
1384855|NCT01410240|Secondary|Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
1384856|NCT01410240|Secondary|Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
1384857|NCT01410240|Secondary|Proportion of Participants With Transfusion Requirements||Intra-operative|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
1384858|NCT01410240|Secondary|Length of Hospital Stay||From the day of hospitalization to the day of discharge|Full Analysis Set|||Days||Standard Deviation|Mean
1384859|NCT01410240|Primary|Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)|"Proportion of Participants who have serious injuries (SIs) related to IP~Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP"|Throughout the study period, 1 year and 4 months|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
1384876|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 2||Pre-operative and day 2 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."|||percent||Standard Deviation|Mean
1384975|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|Proportion (per cent) of sperm cells with abnormal appearance|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat.|||per cent||Standard Deviation|Geometric Mean
1384860|NCT01410240|Secondary|Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6|"Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.~Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) – (Baseline Scores)."|Baseline and Postoperative Weeks 1, 2, and 6||||Scores on a scale||Standard Deviation|Mean
1384861|NCT01410240|Secondary|Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.|Preoperative, and Postoperative Weeks 1, 2, and 6|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
1384862|NCT01410240|Secondary|Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores|"A well-validated scale to reflect problems in people with lower limb issues.~Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)~Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)~Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).~Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues).~Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1384863|NCT01410240|Secondary|Western Ontario and McMaster Universities (WOMAC) Function Index Scores|"A well-validated scale to reflect problems in people with lower limb issues.~Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)~Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)~Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD)~Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).~Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues)~Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1384864|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1384865|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1384866|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1384867|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1384868|NCT01410240|Secondary|Visual Analogue Scale (VAS) Pain Scores|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
1384869|NCT01410240|Secondary|Pain Management - Number of Days When Pain Medication Was Used|"Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis.~While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary."|Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6|Full Analysis Set|||days||Standard Deviation|Mean
1384870|NCT01410240|Secondary|Total Drain Output at Day 1 Post-operatively||1 day post-operatively|Full Analysis Set|||mL||Standard Deviation|Mean
1384871|NCT01410240|Secondary|Transfusion Requirements - Packed Red Blood Cells||Intra-operatively (Day 0) thru Postoperative Day 3|Full Analysis Set - participants with transfusion requirement|||mL||Standard Deviation|Mean
1384872|NCT01410240|Secondary|Duration of Surgery||Time from first incision to complete wound closure (Day 0)|Full Analysis Set|||minutes||Standard Deviation|Mean
1384877|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 1|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.|Pre-operative and day 1 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."|||percent||Standard Deviation|Mean
1384878|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.|Pre-operative and day 3 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."|||g/dL||Standard Deviation|Mean
1384879|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively||Pre-operative and day 1 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."|||g/dL||Standard Deviation|Mean
1384880|NCT01410240|Primary|Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively||Pre-operative and 2 days post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the primary outcome assessment of Hgb level at postoperative Day 2 were excluded from the primary outcome analysis."|||g/dL||Standard Deviation|Mean
1384881|NCT01410227|Secondary|PK80- Ratio of Intra-participant PK of VWF:RCo, VWF:Ag and VWF:CB at Baseline and After 6 Months|Area under the plasma concentration curve (AUC) from time 0 to infinity per dose (AUC0-∞/dose) for von Willebrand Factor Ristocetin cofactor (VWF:RCo), von Willebrand Factor Antigen (VWF:Ag) and von Willebrand Factor Collagen Binding (VWF:CB). Each parameter was compared between the two PK assessments after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. 13 participants had data available for this endpoint i.e. data for PK1 and PK2.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|Participants from the PK80 Arm who had pharmacokinetic (PK) data available after both the first infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] [PK1] and the second infusion of 80 IU/kg rVWF [PK2].|||ratio of AUC0-∞/dose||90% Confidence Interval|Geometric Mean
1384882|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384883|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384884|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
1384885|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384976|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|This was determined as the proportion (percent) of the total sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat|||Per cent||Standard Deviation|Geometric Mean
1384886|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384887|NCT01410227|Secondary|PK80 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
1384888|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384889|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participatns from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384890|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384891|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
1384892|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384957|NCT01410097|Secondary|Modified Mini-Mental Status Exam (3MS)|The Modified Mini-Mental Status Exam (3MS) was used to assess global cognitive function. Scores range from 0 to 100 with higher scores indicating better cognitive function. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||Score on a scale||Standard Deviation|Mean
1384893|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384894|NCT01410227|Secondary|PK80 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
1384895|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384896|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384897|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384898|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study. PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
1384899|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384968|NCT01409993|Primary|Glucose Infusion Rate|In the group of subjects undergoing euglycemic clamp (Aim 2)|2.5 hours after 3 months of therapy|one subject in the sildenafil Aim 2 arm has incomplete data from the three-month clamp due to infusion dysfunction|||mL/hr||Standard Deviation|Mean
1384900|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384901|NCT01410227|Secondary|PK80 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
1384902|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384903|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384904|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384905|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of FVIII:C|Volume of Distribution at Steady State (Vss) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
1384906|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of FVIII:C|Elimination Phase Half-Life (T1/2) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384907|NCT01410227|Secondary|PK50 - Incremental Recovery of FVIII:C|Incremental Recovery (IR) at the maximum plasma concentration of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1388715|NCT01369784|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status|ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus|At the beginning of the 2nd line of treatment||||participants|||Number
1384908|NCT01410227|Secondary|PK50 - Clearance of FVIII:C|Clearance (CL) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
1384909|NCT01410227|Secondary|PK50 - Mean Residence Time of FVIII:C|Mean Residence Time (MRT) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384910|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384911|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384912|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants[N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
1384913|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384914|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384915|NCT01410227|Secondary|PK50 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
1384942|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to FVIII|Development of neutralizing antibodies (inhibitors) to factor VIII (FVIII) was assessed by the Nijmegen modification of the Bethesda assay. Positive FVIII inhibitor tests were defined as ≥ 0.4 Bethesda units/mL (BU/mL) by the Nijmegen-modified Bethesda assay that is confirmed by a second test performed on an independent sample obtained 2-4 weeks following the first test. Category title includes number of participants [N] who provided data for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
1384916|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384917|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384918|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384919|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
1384920|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384921|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384922|NCT01410227|Secondary|PK50 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
1384923|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384956|NCT01410110|Primary|Days of Sobriety in First 90 Days|Abstinence will be determined by toxicology screening, breathalyzer and substance abuse calendar weekly during 3 months of active intervention. Days of sobriety has a range of 0 to 90 with higher being a better outcome.|3 months||||Days of Sobriety||Standard Deviation|Mean
1384924|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384925|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384926|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
1384927|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384928|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384929|NCT01410227|Secondary|PK50 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
1384930|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
1384931|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1388716|NCT01369784|Secondary|MUM-1 Expression|immunohistochemical reaction of cells with MUM-1 antibody|At the beginning of the 2nd line of treatment||||percentage of participants|||Number
1384932|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for subjects in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
1384933|NCT01410227|Secondary|Number of Adverse Events by Infusion Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) by infusion related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of Adverse Events|Infusions||Number
1384934|NCT01410227|Secondary|Number of Participants With Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Number of participants with Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of participants|||Number
1384935|NCT01410227|Secondary|Number of Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS). Category title includes number of AEs [N] for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of Adverse Events|Adverse Events||Number
1384936|NCT01410227|Secondary|Percentage of Participants Who Had an Occurrence of Thrombotic Events||After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
1384937|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to Mouse Immunoglobulin|The presence of total binding anti-Murine immunoglobulin (IgG) antibodies was determined using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
1384938|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to rFurin|The presence of total binding anti-rFurin antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against rFurin protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
1384939|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to CHO|The presence of total binding anti-CHO antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against Chinese Hamster Ovary (CHO) protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
1384940|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to VWF|The presence of total binding anti-VWF antibodies was determined by an enzyme-linked immunosorbent assay (ELISA) employing polyclonal anti-human immunoglobulin (Ig) antibodies (IgG, IgM and IgA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
1384941|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to VWF|Neutralizing antibodies (inhibitors) to Von Willebrand Factor Ristocetin cofactor (VWF:RCo), VWF collagen binding (VWF:CB) and VWF Factor VIII binding (VWF:FVIIIB) activities were measured using Nijmegen modification of the Bethesda assay. One Bethesda Unit (BU) is thereby defined as the amount of inhibitor that decreased the measured activity in the assays to 50% of that of the negative control samples. The assays were validated using human plasma samples from two type 3 VWD patients with low (1-2 BU/mL) and high (~10 BU/mL) titer inhibitors and plasma samples from non-human primates immunized with human rVWF (>100 BU/mL). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
1384969|NCT01409993|Primary|Index of Tissue Sensitivity to Insulin|in the group of subjects undergoing hyperglycemic clamp (Aim 1), calculated by dividing the average glucose infusion rate during the last hour of the clamp by the average plasma insulin concentration during the same interval|2.5 hours after 3 months of therapy||||(mg/kg/min per microU/mL)*100||Standard Error|Mean
1384943|NCT01410227|Secondary|Number of Units of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The number of units is provided as the actual dose [IU/kg] of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant’s PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product of known lot number with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||IU/kg|Bleeding episodes|90% Confidence Interval|Median
1384944|NCT01410227|Secondary|Number of Infusions of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The actual number of infusions of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant's PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of infusions|Bleeding episodes|90% Confidence Interval|Median
1384945|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good, Excluding Gastrointestinal Bleeds"|"Efficacy ratings of excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs excluding gastrointestinal (GI) bleeds treated with study product with an available efficacy rating from participants in the Full Analysis Set."|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of bleeding episodes|Bleeding episodes|90% Confidence Interval|Geometric Mean
1384946|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good"|"Efficacy ratings excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set"|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of bleeding episodes|Bleeding episodes|90% Confidence Interval|Number
1384947|NCT01410227|Primary|Percentage of Participants With Treatment Success for Treated Bleeding Episodes|Treatment success was defined as the extent of control of bleeding episodes (BEs) using a mean efficacy rating score of <2.5 for a participant’s BEs treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) during the study period. Scores used: Excellent = 1 - actual infusions ≤ estimated number of infusions required to treat BE; no additional VWF required (all BEs); Good = 2 - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); Moderate = 3 ≥ 3 infusions (minor/moderate BEs) or ≥ 1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); None = 4 - severe uncontrolled bleeding or intensity of bleeding not changed; additional VWF required. Included participants with available primary efficacy rating (prospective-excluding gastrointestinal bleeds) in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants||90% Confidence Interval|Number
1384948|NCT01410110|Secondary|Global Index|Comprised of the average of 5 Index T Scores (Attention, Processing Speed, Visual and Verbal Memory and Learning, Working Memory and Executive Function). T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
1384949|NCT01410110|Secondary|Executive Function|Mazes, Wisconsin Card Sorting Task (WCST) Perseverative Error, Non-Perseverative Error, Conceptual Level. T Scores for each variable were averaged together. T Scores have a range of 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
1384950|NCT01410110|Secondary|Verbal and Visual Working Memory|WAIS Digit Span and Wechsler Memory Scale (WMS) Spatial Span. T Scores are averaged. T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Month, 6 Months||||T Scores||Standard Deviation|Mean
1384951|NCT01410110|Secondary|Verbal and Visual Learning and Memory|Brief Visual-Spatial Memory Test (BVMT) and Hopkins Verbal Learning and Memory Test (HVLT). Total Score T Scores for tests were averaged. T score range is 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
1384952|NCT01410110|Secondary|Processing Speed Index|Wechsler Adult Intelligence Scale (WAIS) Digit Coding and Symbol Search. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
1384953|NCT01410110|Primary|Weeks of Sobriety|0 to 26 Weeks. Higher number of Weeks is better.|26 weeks|1 additional participant in Work Therapy Only had missing data for this variable.|||Weeks||Standard Deviation|Mean
1384954|NCT01410110|Primary|Days of Use in Prior 30 Days|Days of Use based on Time-Line Follow-back, Toxicology Screen, Breathalyzer, and Chart Review. The range at 6 month follow-up is 0 to 30 days of use with more days being a worse outcome.|30 Days Prior to 6 month follow-up||||Days of Use||Standard Deviation|Mean
1384955|NCT01410110|Secondary|Attention Index|Index comprised on Trails A and Continuous Performance Test. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 month and 6 month follow-up||||T Scores||Standard Deviation|Mean
1384970|NCT01409993|Primary|Insulin Secretion|in the group of subjects undergoing hyperglycemic clamp (Aim 1)|2.5 hours after 3 months of therapy|Glucose-stimulated insulin secretion from 90 to 120 minutes of hyperglycemic clamp|||microU/mL||Standard Error|Mean
1384958|NCT01410097|Secondary|Modified Stroop Color and Word Test|The Modified Stroop Color and Word Test was used to assess executive function. The test measures a participant’s ability to view complex visual stimuli and to respond to one stimulus dimension while suppressing response to another competitive stimulation. The participant first reads aloud words denoting colors printed in black ink (Subtest 1), then names aloud the color of blocks printed in colored ink (Subtest 2), and finally names aloud the color ink in which the words are printed in which are incongruent to the word (Subtest 3). The amount of time to complete each subtest and the number of errors are recorded and interference calculated as time to complete Subtest 3 - Subtest 1 + errors (lower interference scores indicate better cognitive performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||score on a scale||Standard Deviation|Mean
1384959|NCT01410097|Secondary|Rey Auditory Verbal Learning Test (RAVLT)|The Rey Auditory Verbal Learning Test (RAVLT) was used to assess verbal memory. The participant is read a list of 15 words five times. After each time the list is given, the participant is asked to immediately recall as many words as possible. Following the fifth recall, an interference list is presented, after which the participant is asked to spontaneously recall words from the original list. After a 10-minute interval has passed, the participant is asked again to recall as many words as possible from the original list. The number of words correctly recalled on the delayed recall were used in the analysis (range, 0-15; higher number correct indicates better performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||number correct||Standard Deviation|Mean
1384960|NCT01410097|Secondary|Digit Symbol Substitution Test (DSST)|The Digit Symbol Substitution Test (DSST) was used to assess working memory. Participants were presented with a legend at the top of the page showing the boxes each with a number from 1 to 9 and below each numbered box is a unique symbol. As rapidly as possible, the participant fills in the randomly ordered boxes with numbers paired with blank boxes with the symbol that corresponds to the number in the legend. The score is the total number of correctly entered symbols completed in 90 seconds (range, 0-133; higher score indicates better performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||number correct||Standard Deviation|Mean
1384961|NCT01410097|Secondary|Trail Making Test (Part A & B)|Trail Making Tests A and B was used to assess attention and concentration (Part A) and executive function (Part B). Part A measures the time (in seconds) to draw lines to connect circled numbers in a numerical sequence and Part B measures the time (in seconds) to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence as rapidly as possible. The difference (in seconds; greater time indicates worse performance) in performance on Part B minus Part A was used in analysis to represent the contrast between performance on the simple (Part A) and alternating conditions (Part B). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||secs||Standard Deviation|Mean
1384962|NCT01410097|Secondary|Knee Extensor Strength|Maximum knee extensor strength (one repetition maximum (1RM)) was assessed on a Nautilus One™ Leg Extension machine. Participants with prior knee surgery on both knees where all or part of the joint was replaced were excluded from testing. The right leg was tested unless there was a contraindication (e.g., prior knee surgery). If participants experienced knee pain during the test and there were no contraindications to test the other leg, the other leg was tested; if participants experienced knee pain on the other leg, the test was terminated. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to achieve maximum knee extensor strength (1RM) were included in the analysis (n=701)|||kg||Standard Deviation|Mean
1384963|NCT01410097|Secondary|Grip Strength|Grip strength (kg) was measured twice in each hand using an isometric Hydraulic Hand Dynamometer (Jamar, Bolingbrook, IL). The maximum of the force from two trials for the stronger hand was used in the analyses. Participants with severe hand pain or recent surgery in both hands were excluded from testing. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to do the grip strength test were included in the analysis (n=907)|||kg||Standard Deviation|Mean
1384964|NCT01410097|Secondary|Gait Speed Over 400 m|A 400 m walk was administered to assess endurance. Participants were instructed to walk at their usual pace and time to complete the 400-m walk was recorded. The 400-m walk test was terminated if the participant reported chest pain, tightness or pressure, significant shortness of breath or difficulty breathing, feeling faint, lightheaded or dizzy, or other pain (e.g., leg pain).Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to complete the 400 m walk were included in the analysis (n=869)|||m/sec||Standard Deviation|Mean
1384965|NCT01410097|Primary|Short Physical Performance Battery (SPPB) Score|The Short Physical Performance Battery (SPPB) was administered to assess lower extremity physical performance and consisted of standing balance tasks (side-by-side, semi- and full-tandem stands for 10 seconds each), time to complete 5 repeated chair stands, and a 6-m walk to assess usual gait speed. Each of the three performance measures was assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to do the SPPB were included in the analysis (n=954)|||Score on a scale||Standard Error|Mean
1384966|NCT01409993|Secondary|Blood Pressure|Systolic blood pressure|3 months||||mmHg||Standard Deviation|Mean
1384967|NCT01409993|Secondary|Fasting Plasma Glucose||3 months||||mg/dL||Standard Deviation|Mean
1384978|NCT01409837|Secondary|Adverse Events Monitoring|The patients were encouraged to report every event promptly by phone to one of the authors (NOG), no matter however minor.Blood pressure measurements were done with mercury sphygmomanometers fitted with adult-size cuffs (Accoson, England). Serum potassium levels were estimated using the flame photometric method as described by Davidson and Henry|At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282|All the patients who were randomized into each group were monitored for adverse events.|||participants|||Number
1384979|NCT01409837|Primary|Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study|The seminal fluid characteristics were assessed twice before the entry of each patient and both at least two-weeks apart. The two values were averaged and recorded as baseline for week 0 while subsequent changes from the baseline were monitored during each of the scheduled visits at weeks 6, 12, 24, 48, 96, 102, 114, 138, 186 and 282. The two groups swopped treatments at the 96th week. The number of pregnancies achieved was also documented throughout the study period.|Week 96.|All the patients randomized into each group were included in the analysis on the basis of intention-to-treat (last value carried forward)|||ml||Standard Deviation|Geometric Mean
1384980|NCT01409707|Primary|Timeline Follow Back|The timeline follow back is a measure of drug and alcohol consumption in the prior 90 days. The timeline follow back is a calendar-based retrospective account of drug and alcohol consumption for a specified period of time (e.g., past 90 days). One of the most commonly reported metrics of drug and alcohol consumption from this measure is percent days abstinent (PDA). Percent days abstinent is simply the proportion of days for the specified period of time (e.g., 90 days) in which drugs or alcohol were not consumed. Percent days abstinent can range from 0 to 100 with 0 representing no abstinence during a specified period of time (i.e., consumed alcohol every day) and 100 representing complete abstinence during a specified period of time.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.|||percentage of days abstinent||Standard Error|Mean
1384981|NCT01409707|Primary|Impact of Event Scale-Revised|The Impact of Event Scale-Revised is a 22-item self-report measure of posttraumatic stress disorder symptoms. The total score for the Impact of Event Scale-Revised ranges from 0 to 88 with lower scores representing less severe symptoms of posttraumatic stress disorder and higher scores representing more severe symptoms of posttraumatic stress disorder.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.|||units on a scale||Standard Error|Mean
1384982|NCT01409564|Secondary|Fazekas Scale|"Level of severity of white matter lesions in AD patients who can be legitimately administered with cilostazol. Measured by professionally trained clinicians.~The higher score indicates more severe white matter lesion. Max-min: 0-3"|Baseline||||participants|||Number
1384983|NCT01409564|Secondary|Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)|"Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms.~Score Scale: 0-18 (min-MAX)"|Baseline, 12-month, 24-month||||units on a scale||Standard Deviation|Mean
1384984|NCT01409564|Secondary|Activities of Daily Living (ADCS-ADL)|"The caregiver answered to the questions given to measure the cognitive function level of the patients in daily living. Lower scores indicate greater severity.~23 questions Score Scale: 0-78 (min-MAX)"|Baseline, 12-month, 24-month||||units on a scale||Standard Deviation|Mean
1384985|NCT01409564|Secondary|Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)|Basic cognitive functions are checked. (0-30) The score is better when higher.|Baseline, 12-month, 24-month||||units on a scale||Standard Deviation|Mean
1384986|NCT01409564|Secondary|Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog)|"The ADAS-Cog score is measured by the number of questions answered incorrectly, therefore the higher is the worse.~Score Scale: 0-75 (min-MAX)~Each subcategory scores are summed.~Word-recall test (0-10)~Commands (0-5)~Constructional praxis (0-5)~Naming Objects/ Fingers (0-5)~Ideational Praxis (0-5)~Orientation (0-8)~Word Recognition (0-12)~Remembering Test Instructions (0-5)~Spoken Language Ability (0-5)~Word Finding Difficulty (0-5)~Comprehension (0-5)"|Baseline, 12-week, 24-week||||units on a scale||Standard Deviation|Mean
1384987|NCT01409564|Primary|Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method|Regional cerebral glucose uptake level was measured as the ratio value of FDG uptake of the each unit level to the global mean uptake value.|Baseline, 24-week|Number of patients with increased whole brain glucose uptake level. In the real analysis, however, a voxel-based image analysis results were used; therefore, data which can be entered here is not much meaningful.|||Bq/Bq (no unit)||Standard Deviation|Mean
1384988|NCT01409434|Secondary|High Density Lipoprotein (mg/dL)||High Density Lipoprotein was obtained at time 0 min.||||mg/dL||Standard Deviation|Mean
1384989|NCT01409434|Secondary|Low Density Lipoprotein (mg/dL)||Low Density Lipoprotein was obtained at time 0 min.||||mg/dL||Standard Deviation|Mean
1384990|NCT01409434|Secondary|Triglycerides (mg/dL)||Triglycerides was obtained at time 0 min.||||mg/dl||Standard Deviation|Mean
1384991|NCT01409434|Secondary|Oral Glucose Tolerance Test (mg/dl h)|Area under the curve for the OGTT was calculated for each patient using the 3 time points (0 hour, 1 hour and 2 hour). Average value for participants is provided.|one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)|Patients that underwent an OGTT|||mg/dL*h||Standard Deviation|Mean
1384992|NCT01409434|Primary|Fasting Glucose (mg/dL)||Fasting glucose was obtained at time 0 min.|A total of 44 patients were included in the study, however 4 patients were treated with anti-diabetic medications and so were excluded from the analysis. Therefore there are a total of 40 patients that were included in the analysis.|||mg/dL||Standard Deviation|Mean
1384993|NCT01409382|Other Pre-specified|Pregnancy and Neonatal Outcomes|Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies|Three years||||participants (babies)|||Number
1385013|NCT01408888|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265|Area under the LY2189265 pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (168 hours) is summarized.|Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 AUC data.|||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1384994|NCT01409382|Secondary|Refractory Hypoglycemia|"Any glucose level ≤ 40/dL at 1, 2 or 4 h:~Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.~A new heel stick blood sample will be drawn to assess glucose levels.~Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia."|One hour after feeding or after intravenous dextrose|All hypoglycemic neonates were screened for refractory hypoglycemia. Only neonates born to mothers who were physically inactive and reported excessive carbohydrate consumption displayed refractory hypoglycemia.|||neonates with refractory hypoglycemia|||Number
1384995|NCT01409382|Primary|Neonatal Hypoglycemia|Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.|1, 2 and 4 h after birth.||||neonates|Participants||Number
1384996|NCT01409291|Secondary|Fast Food Meals Per Week|Mean number of fast food meals per week|1 year||||meals per week||Standard Deviation|Mean
1384997|NCT01409291|Primary|Minutes of Exercise Per Week|Mean minutes of exercise per week|1 year||||minutes||Standard Deviation|Mean
1384998|NCT01409239|Primary|Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group|difference in mean low frequency/high frequency heart rate variability (LF/HF HRV)at 6 hour. 2 patients were excluded who did not have usable LF/HF HRV data at 6 hours. These patients remained in the study as they did have other measures.|6 hour||||none (ratio)||Inter-Quartile Range|Median
1384999|NCT01409213|Primary|Change From Baseline for Mean Fasting Blood Glucose (FBG)|Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.|||mg/dL||Standard Deviation|Mean
1385000|NCT01409213|Primary|Change From Baseline for Mean Hemoglobin A1c (HbA1C)|Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.|||Percent of glycosylated hemoglobin||Standard Deviation|Mean
1385001|NCT01409096|Secondary|Hamilton Rating Scale for Anxiety (HRSA)|"The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where less than 17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe."|12 weeks||||units on a scale||Standard Error|Least Squares Mean
1385002|NCT01409096|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).~Score:~Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks||||units on a scale||Standard Error|Least Squares Mean
1385003|NCT01409096|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.~Score:~Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks||||units on a scale||Standard Error|Least Squares Mean
1385004|NCT01409096|Primary|The 17-item Hamilton Rating Scale for Depression (HRSD17)|"The HRSD is an observer-rated measure of depressive symptomatology.~Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less."|12 weeks||||units on a scale||Standard Error|Least Squares Mean
1385005|NCT01408992|Primary|Standard Hearing Test|Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB).|Baseline||||participants|||Number
1385006|NCT01408992|Post-Hoc|Sensitivity of FMHT to Detect the Hearing Loss.|"FMHT has 15 questions and there are 4 possible answer for each question. The best possible answer is never and is scored 0, occasionally is scored 1, half the time is scored 2 and almost always the worst answer is scored 3. The total possible range for the FMHT scores 0-45. We then compared the total score with the better hearing ears as in Outcome measure 1. The total number of participants with a score from 0 to 45, and that all participants in the study had a score within this range. It would appear, from information provided in the previous version of this record, that the total score might range from 0 to 45."|baseline|The frequencies of subjects who had FMHT score from 0 to 45 were counted.|||participants|||Number
1385007|NCT01408992|Secondary|Prevalence of Ear Diseases|the frequency of diseased ears per the total examined ears|Immediate||||ears|Participants||Number
1385008|NCT01408914|Secondary|Incidence of Rifampin-related Grade 2 or Higher Adverse Events|Number of participants experiencing at least one rifampin-related grade 2 or higher adverse events during the initial 8 weeks of treatment and up to four weeks after.|Throughout the 12 weeks post treatment initiation||||Participants|||Count of Participants
1385009|NCT01408914|Secondary|Sputum Culture Sterilization During the Initial 8 Weeks of Treatment|Number of participants that are sputum culture (in LJ) negative for TB at 8 weeks|Until 8 weeks of treatment are completed||||Participants|||Count of Participants
1385010|NCT01408914|Primary|Steady State Pharmacokinetic Exposure of RIF|The endpoint is the (dimensionless) ratio of AUC0-6 mcg/ml*h to MIC99.9 mcg/ml|At any time during the intensive phase of treatment, after steady state has been reached (at a minimum, after 14 days of daily RIF delivery)|Analysis was completed in 168 participants evaluable for pharmacokinetics, as samples were unable to be collected in 12 study participants.|||Ratio||Inter-Quartile Range|Median
1385011|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 tmax data.|||hours||Full Range|Median
1385012|NCT01408888|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1388717|NCT01369784|Secondary|Multiple Myeloma Oncogene 1 (MUM-1) Expression|immunohistochemical reaction of cells with MUM-1 antibody|At diagnosis||||percentage of participants|||Number
1385015|NCT01408888|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin||Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1385016|NCT01408888|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin|Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (24 hours) is summarized.|Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin AUC data.|||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1385017|NCT01408862|Primary|Changes in Basal or Aggregant-induced Platelet Activation (With and Without Glucose Added to the Media, 200 mg/dl, 400 mg/dL) by GLP-1-(7-36)NH2 and Its Metabolite (GLP-1-(9-36)NH2)and a GIP Agonist at Different Concentrations.|"1 Direct effect of GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist on platelet aggregation, with and without preincubation at different glucose concentrations.~2. GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist modulation (with and without 300 mg/dL glucose added to the media) of platelet activation and aggregation induced by classical platelet agonists such as ADP, collagen and bovine von Willebrand factor.~Data points from various conditions were combined (averaged),"|Platelets drawn from a volunteer will be evaluated 1 time (in 1-2 days)|We assume that with 10 samples per condition divided in 5 categories (1 control plus 4 concentrations of GLP1 and GIP agonists) for a standardized difference of 0.5 between groups and a p=0.05, the statistical power would be higher than 90%. We used a similar design to test the effect of GLP1 and GIP agonists on platelet aggregants.|||% of Inhibition||Standard Deviation|Mean
1385018|NCT01408862|Primary|Expression of Glucagon Like Peptide -1 (GLP-1) and Gastric Inhibitory Peptide (GIP) Receptors in Normal Human Platelets|1.1 Measurement of GLP-1 and GIP receptors at the platelet RNA level by Real Time-PCR 1.2 GLP-1 and GIP receptors detection at the protein level: 1.2.1 Expression on platelet membrane by flow cytometry. 1.2.2 Detection in total platelet proteins by western-blot. Data of flow cytometry are provided below|Platelets drawn from a volunteer were evaluated 1 time (in 1-2 days)||||percentage of positive cells||Standard Deviation|Mean
1385019|NCT01408732|Primary|Severityof Epistaxis|The primary outcome measure will be severity of epistaxis as measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed online questionarrie that calculates the grading system for epistaxis severity. The higher the score the more severe the nose bleeds are Scale consists of several questions with a range of scale from 0-5 The average score is calculated for a final assessment|Change from Baseline to 14 weeks||||units on a scale||Standard Deviation|Mean
1385020|NCT01408719|Secondary|Changes in Body Weight and Waist Circumference(WC)|Body weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.|Every day for body weight; beginning and end of each phase for WC|||||||
1385021|NCT01408719|Primary|Changes in LDL Cholesterol|Serum LDL cholesterol will be estimated using the Friedewald equation.|Beginning and end of each phase|||||||
1385022|NCT01408719|Secondary|Potential Gene-nutrient Interactions: CYP7A1 and APOE|The Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.|Once for each participant|||||||
1385023|NCT01408719|Secondary|Cholesterol Absorption/Synthesis|The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.|End of each phase|||||||
1385024|NCT01408719|Primary|Changs in Total Cholesterol|Fasted total cholesterol concentration will be measured using the automated enzymatic methods.|Beginning and end of each phase||||mmol/L||Standard Error|Least Squares Mean
1385025|NCT01408706|Secondary|Patient Expression of Discomfort|Patient expression of discomfort was scored for each insertion by the treating radiation therapist on a scale from 1(none) to 5(intolerable). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .|Up to nine weeks||||units on a scale||Full Range|Mean
1385026|NCT01408706|Secondary|Difficulty of Insertion.|Difficulty of device insertion was scored for each treatment by the treating radiation therapist on a scale from 1(easiest) to 5(most difficult). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .|Up to nine weeks||||units on a scale||Full Range|Mean
1385027|NCT01408706|Primary|Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.|Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment. An average value will be determined for each patient. An average of individual patient values will be determined for each immobilization device.|Up to 9 weeks||||CENTIMETERS||Standard Deviation|Mean
1385028|NCT01408641|Secondary|Amount of PTSD Symptoms|The Clinician Administered PTSD Scale (CAPS) contains 30 questions relating to PTSD symptoms. Each question asks about both the frequency and the severity of each symptom. These questions are split into categories. Each criterion has several questions, and scores for each criterion are added up at the end. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.|14 weeks|There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013.||||||
1385029|NCT01408641|Primary|Percentage of Heavy Drinking Days|The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.|14 weeks|There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013.||||||
1385030|NCT01408628|Secondary|Severity of Self-reported Hypoglycemia|Severity was defined by the scale used by the DCCT: grade 1 - subject was able to recognize and treat appropriately without assistance; grade 2 - subject required help from another person either to recognize or recognize/treat; grade 3 - subject required injection of glucagon or treatment in ER|6 Months|Subjects who completed both the Internet intervention and the 6 months of follow up|||incidents (count)|||Number
1385031|NCT01408628|Secondary|Change in HbA1c|Change in HbA1c (average measure of the % of glycosolated hemoglobin in the blood over the past 3 months) from baseline to end of follow up period.|Change from Baseline through Month 6 of follow-up period|Subjects who both completed the Internet intervention and the six months of follow up|||percentage of glycosolated hemoglobin||Standard Deviation|Mean
1385032|NCT01408628|Primary|Frequency of Hypoglycemia|Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject.|6-month follow up period following the Internet Intervention|Subjects who both completed the Internet intervention AND the 6 months of follow up|||incidents per person-year||Standard Deviation|Mean
1385033|NCT01408537|Secondary|Neutralizing Antibody Persistence One Year After the Primary Vaccination|To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.|1 year after primary vaccination|The analysis was excluded 5 subjects who had NT titer >10 on D0|||participants|||Number
1385034|NCT01408537|Secondary|Adverse Events of Vaccine|To determine the adverse events of JEVAC|7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively|Determined AEs by number of injections 152 injection for the first dose 151 injection for the second dose 145 injection for the third dose|||events|Participants||Number
1385035|NCT01408537|Secondary|Geometric Mean Titer of NT After Primary and Booster Vaccination|To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.|28 days after second vaccination, before and 28 days after booster vaccination with JEVAC|152 were enrolled, 1 withdrawn consent before second vaccine, 5 had NT >= 10 before first vaccine, 146 included in D28 after second vaccine. At 1 year, 3 received JE vaccine outside the study, 3 lost follow up, 140 included in before booster, At D28 after booster, 1 could not draw blood, 139 included in D28 after booster.|||titer||95% Confidence Interval|Geometric Mean
1385036|NCT01408537|Primary|Seroconversion Rate After Primary Vaccination|To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from <10 on before first vaccination To >= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer >=10 before first vaccination, will not be included in immunogenicity evaluation.|28 days after second dose of JEVAC|There were 152 enrolled subjects in the study. However, 5 subjects had NT titer >= 10 before first vaccination and one subject whom blood on 28days after second vaccination was not drawn due to withdrawn consent. Therefore, the number of subjects for the outcome measurement should be 146.|||percentage of seroconversion|||Number
1385037|NCT01408485|Secondary|Secondary Efficacy|Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.|3 months||||participants|||Number
1385038|NCT01408485|Primary|Primary Efficacy|Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes||||participants|||Number
1385039|NCT01408485|Primary|Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.|||participants|||Number
1385040|NCT01408329|Primary|Plasma Glucose Concentration||Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10–12 h fast the morning after a CVAC session (except for baseline).|Those that completed the study|||mg/dl||Standard Deviation|Mean
1385041|NCT01408303|Primary|Serum Non-HDL Cholesterol|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.|6 weeks|"The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented."|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
1385042|NCT01408277|Primary|Mean Percent Change in Wound Area|Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.|6 and 12 weeks|Primary analysis was based on the Intent-to-treat dataset which consisted of all subjects randomized to treatment.|||percentage of change in wound area||Standard Error|Mean
1385043|NCT01407575|Primary|Weight|Participant weight|6 weeks||||lbs||Standard Deviation|Mean
1385044|NCT01407575|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|6 weeks||||Beats per minute||Standard Deviation|Mean
1385045|NCT01407575|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 – 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 – 50, with lower scores representing lower levels of negative affect."|6 weeks|reduced sample size verified. This was secondary to administrative error.|||units on a scale||Standard Deviation|Mean
1385046|NCT01407575|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|6 weeks||||units on a scale||Standard Deviation|Mean
1385050|NCT01407523|Secondary|Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|During the Evaluation Period (Day 1 to Day 4)|Full Analysis Set (FAS). The FAS consisted of all subjects in the Safety Set (SS) with evaluable seizure frequency data over the Evaluation Period. All 16 subjects in the SS are included in the FAS.|||Seizures per day||Inter-Quartile Range|Median
1385051|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1385052|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1385053|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1385054|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1385055|NCT01407523|Primary|Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)|A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)|||participants|||Number
1385056|NCT01407523|Primary|Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)|||participants|||Number
1385057|NCT01407354|Secondary|Number of Movement Recorded by Activity Monitor (SAM)|SAM movements not just steps were gathered one time pre, crossover and post and worn on ankle for 5 days; percent change for each intervention|7 months||||number of movements||Standard Deviation|Mean
1385058|NCT01407354|Primary|Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak|Peak VO2 via Arm Ergometer and Lokomat with metabolic cart|7 months||||participants|||Number
1385059|NCT01407276|Secondary|Number of Participants Withdrawn From Study||Up to Day 15|All participants that received a single 3 mg dose of omarigliptin.|||Participants|||Number
1385060|NCT01407276|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|From pre-dose to 14 days post-dose (Up to Day 15)|All participants that received a single 3 mg dose of omarigliptin.|||Participants|||Number
1385061|NCT01407276|Primary|Apparent Terminal Half-life (t1/2) of Omarigliptin|T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||hour||Standard Deviation|Mean
1385062|NCT01407276|Primary|Time to Maximum Concentration (Tmax) of Omarigliptin|Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||hour||Full Range|Median
1385063|NCT01407276|Primary|Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin|Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||mg||95% Confidence Interval|Least Squares Mean
1385623|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||ml||Standard Deviation|Mean
1385064|NCT01407276|Primary|Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin|fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||Percentage of total dose||95% Confidence Interval|Geometric Mean
1385065|NCT01407276|Primary|Renal Clearance (CLr) of Omarigliptin|CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||mL/min||95% Confidence Interval|Geometric Mean
1385066|NCT01407276|Primary|Apparent Total Body Clearance (CL/F) of Omarigliptin|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||mL/min||95% Confidence Interval|Geometric Mean
1385067|NCT01407276|Primary|Apparent Volume of Distribution (Vd/F) of Omarigliptin|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||L||95% Confidence Interval|Geometric Mean
1385068|NCT01407276|Primary|Concentration at 168 Hours Post-dose (C168h) of Omarigliptin|C168h is a measure of the plasma drug concentration 168 hours post-dose.|168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM||95% Confidence Interval|Geometric Mean
1385069|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin|AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM*hr||95% Confidence Interval|Geometric Mean
1385070|NCT01407276|Primary|Maximum Concentration (Cmax) of Omarigliptin|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM||95% Confidence Interval|Geometric Mean
1385071|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM*hr||95% Confidence Interval|Geometric Mean
1385072|NCT01407068|Secondary|Clinical Success by Joint Type|Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.|30 days after injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||number of joints|Number of joints||Number
1385073|NCT01407068|Primary|Change in Total Range of Motion|The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||degrees||Standard Deviation|Mean
1385074|NCT01407068|Secondary|Investigator Assessment of Improvement With Treatment|"At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject’s treated finger(s) compared with screening as follows:~Very Much Improved~Much improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||participants|||Number
1385075|NCT01407068|Secondary|Subject Satisfaction With Treatment|"At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows:~Very Satisfied~Quite Satisfied~Neither Satisfied nor Dissatisfied~Quite Dissatisfied~Very Dissatisfied"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||participants|||Number
1385076|NCT01407068|Primary|Percent Change From Baseline in Total Fixed Flexion|Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||percentage of contracture change||Standard Deviation|Mean
1385077|NCT01406990|Primary|Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin|Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.|Time of enrollment||||participants|||Number
1385078|NCT01406938|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies will decrease a participant’s ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60|Baseline, weeks 12, 24, 52 and 60|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Number of participants|||Number
1385079|NCT01406938|Secondary|Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12|The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12|week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||percent of participants|||Number
1388718|NCT01369784|Secondary|p53 Expression|immunohistochemical reaction of cells with p-53 antibody|At the beginning of the 2nd line of treatment||||percentage of participants|||Number
1385080|NCT01406938|Secondary|Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participants|||Number
1385081|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included|||Percent of participants|||Number
1385082|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included|||Percent of participants|||Number
1385083|NCT01406938|Secondary|Median Time to Relapse (Weeks) From Week 12.|Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement|Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Number of weeks||95% Confidence Interval|Median
1385084|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participant|||Number
1385085|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participants|||Number
1385086|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1388719|NCT01369784|Secondary|p-53 Expression|immunohistochemical reaction of cells with p-53 antibody|At diagnosis||||percentage of participants|||Number
1385087|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1385088|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1385089|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)|ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example “confined to bed”) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1385090|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant’s disease state at the time of the assessments and does not attempt a comparison to any of the participant’s previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe|Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participants|||Number
1385091|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe|Baseline, week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participant|||Number
1385092|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1385093|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 2, 3 , 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
1385094|NCT01406938|Primary|For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 40 , week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned.|||Percent of participants|||Number
1385110|NCT01406795|Secondary|Secondary Patency|Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency.|up to 1 year||||Participants|||Count of Participants
1388733|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria||upto 7 days after surgery||||participants|||Number
1385095|NCT01406873|Secondary|Mean Change From Baseline in Patient-Reported Disease Burden and Quality of Life|"The Myotonic Dystrophy Health Index (MDHI) is a validated disease-specific measure of patient-reported disease burden. The MDHI total score is a weighted average derived from 17 subscales. MDHI total scores range form 0-100 with 0 representing no patient-reported disease burden and 100 representing the most severe patient-reported disease burden.~The Individualized Neuromuscular Quality of Life Questionnaire (INQoL) is a measure of quality of life in neuromuscular disease. The INQoL summary score is a weighted average made up of 5 sub-domains. Scores range from 0-100, and can be interpreted as the percent of maximal detrimental impact on quality of life with higher scores indicating more detrimental impact.~The 36-Item Short Form Survey (SF-36) is a generic measure of quality of life across 8 domains. Two summary metrics are produced from the 8 domains, ranging from 0-100% with lower scores representing worse levels of functioning."|Baseline to 6 months|Intent to treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1385096|NCT01406873|Secondary|Mean Change From Baseline in PR, QRS, and QTc Intervals, and Average Minimum Heart Rate (HR) Via Electrocardiogram (ECG) Monitoring|PR, QRS, and QTc intervals as well as average minimum heart rate (HR) were obtained through standard 12 lead electrocardiograms (ECGs). Values were computer generated and verified by the study investigator and study cardiologist.|Baseline to 6 Months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Milliseconds||Standard Error|Mean
1385097|NCT01406873|Secondary|Mean Change From Baseline in Manual Muscle Testing (MMT) Score|Manual muscle testing was performed on 26 muscle groups (shoulder abductors, elbow flexors, wrist flexors, wrist extensors, hip flexors, knee extensors, hip extensors, knee flexors, hip abductors, elbow extensors, ankle dorsiflexors, and plantar flexors on the right and left plus neck extensor and neck flexors). The muscles were tested in various positions including sitting, supine, prone, and side lying and each graded on a modification of the Medical Research Council (MRC) scale of 0 to 5 (5 representing normal strength). Average MMT score is derived by averaging the individual MMT scores across the 26 individual muscles.|Baseline to 6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1385098|NCT01406873|Secondary|Mean Change From Baseline in Quantitative Measure of Hand Grip Myotonia|Relaxation time of the long finger flexor muscles of the right hand after a maximum voluntary isometric contraction performed in a standardized fixed position of the right arm elbow/wrist/hand. Relaxation time for this measurement is defined as the time to relax from 90% to 5% of the maximum isometric force of contraction of the hand (the first of 6 serial contractions averaged over two consecutive trials performed 10 minutes apart).|Baseline to 6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication, and have post-baseline efficacy assessment at 6 months. Data was not analyzable on 3 people in the placebo arm.|||Seconds||Standard Deviation|Mean
1385099|NCT01406873|Secondary|Percentage of Participants That Had a Dose Reduction or a Study Drug Withdrawal or Suspension Over 6 Months|Adverse events were monitored at the three in-person evaluations (Months 0, 3, and 6), at telephone evaluations every 2 weeks, and via patient-completed side effect diaries. The study investigators and safety monitoring committee reviewed adverse events and made decisions regarding drug withdrawals, suspensions, and dose reductions as needed.|6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Participants|||Count of Participants
1385100|NCT01406873|Primary|Mean Change From Baseline in Ambulation Using the 6 Minute Walk Distance|During this assessment, participants were asked to walk as far as they could back and forth on a fixed 20 meter route for 6 minutes. The total distance walked during the 6 minutes was recorded in meters. Change from baseline was defined as the difference between the average 6 minute walk distance at baseline and the average 6 minute walk distance at 6 months.|Baseline to 6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment. Follow-up data was not collected on one participant in the mexiletine arm due to a broken foot.|||Meters||Standard Deviation|Mean
1385101|NCT01406860|Secondary|Adverse Effects|Frequency of adverse effects in each arm|From the time when the treatment is initiated until the 24 hour follow-up phone survey|Data were not collected||||||
1385102|NCT01406860|Secondary|24 Hour Pain Score|24 hour pain score (follow-up phone call)|24 hours after discharge from ED|Data were not collected||||||
1385103|NCT01406860|Secondary|Length of Stay||Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)|Data were not collected||||||
1385104|NCT01406860|Primary|Pain Scale (Numerical Rating Scale for Pain)|Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain|Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)|Data were not collected||||||
1385105|NCT01406795|Secondary|Villalta PTS Scale|The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease.|up to 2 years|Data were not collected for this outcome.||||||
1385106|NCT01406795|Secondary|VEINS-QOL|The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure.|Up to 2 years||||Participants|||Count of Participants
1385107|NCT01406795|Secondary|Venous Clinical Severity Score|Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient.|up to 2 years|Data were not collected for this outcome||||||
1385108|NCT01406795|Secondary|Decrease in Swelling of Affected Extremity|The count of participants that experienced a decrease in swelling after the stent was placed.|up to 2 years||||Participants|||Count of Participants
1385111|NCT01406795|Secondary|Assisted-primary Patency|Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency.|up to 1 year||||Participants|||Count of Participants
1385112|NCT01406795|Secondary|Freedom From Device-related Amputation|Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement.|up to 1 year following the procedure||||Participants|||Count of Participants
1385113|NCT01406795|Primary|Primary Patency Rate|Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with >= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.|up to 1 year following the procedure||||Participants|||Count of Participants
1385114|NCT01406795|Primary|Stent Migration|Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.|up to one year following the procedure 1 year||||Participants|||Count of Participants
1385115|NCT01406795|Primary|Stent Migration|Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.|up to 1 month following the procedure||||Participants|||Count of Participants
1385116|NCT01406574|Secondary|Best Overall Response|Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.|From first dose of study medication up to 28 weeks|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.~No statistical analysis provided for Best Overall Responders."|||participants|||Number
1385117|NCT01406574|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.~DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice"|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|"DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4.~No statistical analysis provided for Subjects With DLTs."|||participants|||Number
1385118|NCT01406574|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame.|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.|||participants|||Number
1385119|NCT01406223|Secondary|Days to First Cigarette Following Quitting Smoking|Days to first cigarette (i.e. lapse) will be measured via self-report.|Up to 11 weeks post quit day.|Twenty-eight subjects dropped from the study prior to their scheduled quit day, so they were not included in these analyses.|||days||Standard Deviation|Mean
1385120|NCT01406223|Primary|The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences|Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity.|change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment|Only participants who completed both scanning sessions and provided useable data were included in imaging analysis.|||percent BOLD signal change||Standard Deviation|Mean
1385121|NCT01406015|Secondary|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Insulin resistance was measured using the 75 G glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 mL of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. HOMA-IR was calculated using the Insulin and glucose levels obtained. A negative change (decrease in insulin resistance) indicates improvement.|Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)|All randomized participants who completed the study.|||IR index||Standard Deviation|Mean
1385122|NCT01406015|Secondary|Change From Baseline in Insulin Sensitivity Index (ISI)|Insulin sensitivity was measured using the 75 gram (G) glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 milliliters (mL) of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. Insulin sensitivity index was calculated by Matsuda and Defronzo’s formula using the values obtained. A positive change from Baseline (increase in insulin sensitivity) indicates improvement.|Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)|All randomized participants who completed the study.|||IS index||Standard Deviation|Mean
1385123|NCT01406015|Secondary|Change From Baseline in Markers of Inflammation|Blood was to be collected and tested for Tumor Necrosis Factor Alpha (TNF-α) and Monocyte Chemotactic Protein-1 (MCP-1), markers of inflammation; However, due to lack of funding, blood samples were not analyzed and data for levels of inflammation markers were not collected.|Baseline and Week 6|Analysis was not performed.||||||
1385124|NCT01406015|Secondary|Change From Baseline in Para-aminohippurate (PAH) Clearance|Renal plasma blood flow was determined by clearance of para-aminohippurate (PAH). A loading dose of PAH (8 mg/kg) was given intravenously followed by a 1 hour constant infusion of PAH at a rate of 12 mg/minute (min). Plasma samples were obtained at Baseline and at 50 and 60 minutes. PAH clearance was calculated from the plasma levels and infusion rates and reported in millimeters (mL)/minute (min). A positive change from Baseline indicates improvement.|Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion)|All randomized participants who completed the study.|||mL/min||Standard Deviation|Mean
1385151|NCT01405794|Secondary|Total Change in Diastolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days||||mmhg||95% Confidence Interval|Mean
1385125|NCT01406015|Primary|Change From Baseline in Post-ischemic Dilatation|Ultrasonography of the brachial artery was performed to evaluate endothelial function by flow mediated dilatation (FMD) studies. A blood pressure cuff was placed on the participant's upper arm and was compressed for 5 minutes. After release of compression, brachial artery diameter and blood flow velocity were measured. FMD was expressed as the percentage change in brachial artery diameter. A positive change from Baseline indicates improvement.|Baseline and Week 6|All randomized participants who completed the study.|||percent dilalation||Standard Deviation|Mean
1385126|NCT01405950|Secondary|Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day~0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine~PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population|||nanogram/mililiter||Standard Error|Mean
1385127|NCT01405950|Primary|Pharmacokinetic (PK) Parameter AUC0–8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day~0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine~PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population|||hour*nanogram/mililiter||Standard Error|Mean
1385128|NCT01405937|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants|||Number
1385129|NCT01405937|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|Participants in the FAS population (all randomized participants who received at least one dose of study treatment) that had HCV RNA data available.|||Log IU/ml||Standard Deviation|Mean
1385130|NCT01405937|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants||95% Confidence Interval|Number
1385131|NCT01405937|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1385132|NCT01405937|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
1385133|NCT01405937|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1385134|NCT01405937|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1385135|NCT01405937|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1385136|NCT01405924|Secondary|Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy|Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
1385137|NCT01405924|Secondary|Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy|"Participants rated their degree of nausea in response to How much nausea have you had over the last 24 hours? using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score <25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated."|From 24 to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
1385138|NCT01405924|Secondary|Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy|"The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. No Impact on daily life was defined as a FLIE Total Score >108. Participants completed the FLIE questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days."|From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2)|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Score on a Scale||Standard Deviation|Mean
1385139|NCT01405924|Secondary|Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy|A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
1385140|NCT01405924|Secondary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data. Participants were grouped into 2 cohorts based on type of chemotherapy received.|||Percentage of Participants|||Number
1385141|NCT01405924|Primary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
1385142|NCT01405898|Secondary|Difference in Change in Arterial Stiffness From Baseline|carotid-femoral pulse wave velocity [m/s] measured by Vicorder|4 weeks||||m/s||Standard Deviation|Mean
1385143|NCT01405898|Primary|Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
1385144|NCT01405898|Primary|Difference in Change in Ambulatory Systolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
1385145|NCT01405898|Primary|Difference in Change in Clinic Diastolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
1385146|NCT01405898|Secondary|Difference in Change in Endothelial Function From Baseline|as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function|4 weeks||||% dilatation||Standard Deviation|Mean
1385147|NCT01405898|Secondary|Difference in Change in Plasma Nitrite Concentration From Baseline||4 weeks||||umol/L||Standard Deviation|Mean
1385148|NCT01405898|Primary|Difference in Change in Clinic Systolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
1385149|NCT01405820|Primary|Cumulative Number of Combined Unique Active Lesions|Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.|Up to Week 60|Modified intent-to-treat (mITT) population: all randomized participants who received at least 1 dose of study drug, had at least 1 efficacy assessment, and had no statistical protocol deviations.|||lesions||Standard Deviation|Mean
1385150|NCT01405794|Secondary|Total Change in Heart Rate in Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days||||beats per minute||95% Confidence Interval|Mean
1385153|NCT01405794|Primary|Cytochrome P450 Assay on Midazolam in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
1385154|NCT01405794|Secondary|Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
1385155|NCT01405794|Primary|Cytochrome P450 Assay on Omeprazole in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
1385156|NCT01405794|Primary|Cytochrome P450 Assay on Caffeine in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
1385157|NCT01405794|Primary|Cytochrome P450 Assay on Losartan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
1385158|NCT01405794|Primary|Cytochrome P450 Assay on Dextromethorphan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
1385159|NCT01405794|Primary|Change In Eosinophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
1385160|NCT01405794|Primary|Change In Basophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
1385161|NCT01405794|Primary|Change In Monocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
1385162|NCT01405794|Primary|Change In Lymphocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
1385163|NCT01405794|Primary|Change In Granulocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
1385164|NCT01405794|Primary|Change In Platelet Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||k/uL||Standard Deviation|Mean
1385165|NCT01405794|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||gm/dL||Standard Deviation|Mean
1385166|NCT01405794|Primary|Change In Mean Corpuscular Volume Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||fL||Standard Deviation|Mean
1385167|NCT01405794|Primary|Change In Hematocrit Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
1385168|NCT01405794|Primary|Change In Hemoglobin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||gm/dL||Standard Deviation|Mean
1385169|NCT01405794|Primary|Change In Red Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||M/uL||Standard Deviation|Mean
1385170|NCT01405794|Primary|Change In White Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||k/uL||Standard Deviation|Mean
1385171|NCT01405794|Primary|Change In Calcium Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dL||Standard Deviation|Mean
1385172|NCT01405794|Primary|Change In Albumin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||g/dL||Standard Deviation|Mean
1385173|NCT01405794|Primary|Change In Total Bilirubin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dL||Standard Deviation|Mean
1385174|NCT01405794|Primary|Change in Total Protein Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||g/dL||Standard Deviation|Mean
1385175|NCT01405794|Primary|Change In Alanine Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||U/L||Standard Deviation|Mean
1385176|NCT01405794|Primary|Change In Aspartate Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||U/L||Standard Deviation|Mean
1385177|NCT01405794|Primary|Change In Alkaline Phosphatase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||U/L||Standard Deviation|Mean
1385178|NCT01405794|Primary|Change In Glucose Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dl||Standard Deviation|Mean
1385179|NCT01405794|Primary|Change In Creatinine Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dL||Standard Deviation|Mean
1385180|NCT01405794|Primary|Change In Urea Nitrogen Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mg/dL||Standard Deviation|Mean
1385181|NCT01405794|Primary|Change in Carbon Dioxide Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mmol/L||Standard Deviation|Mean
1385182|NCT01405794|Primary|Change in Chloride Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mmol/L||Standard Deviation|Mean
1385183|NCT01405794|Primary|Change Potassium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mmol/L||Standard Deviation|Mean
1385184|NCT01405794|Primary|Change Sodium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mmol/L||Standard Deviation|Mean
1385185|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure||||units on a scale||Full Range|Median
1385186|NCT01405768|Primary|Injection Pain Score (Median)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of the procedure||||units on a scale||Full Range|Median
1385187|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure||||units on a scale||Standard Deviation|Mean
1385188|NCT01405768|Primary|Injection Pain Score (Mean)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure||||units on a scale||Standard Deviation|Mean
1385189|NCT01405742|Secondary|F.VIII Activity|F.VIII Activity (IU/mL) performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.||||IU/mL||Full Range|Median
1385190|NCT01405742|Secondary|Inter-dose Hypocoagulability by Thrombin Generation|Thrombin generation was performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.||||nMs||Full Range|Median
1385191|NCT01405742|Primary|Number of Bleeds|The primary outcome was bleed frequency. The data were total number of events for each Arm, and not per-participant.|Weeks 26 (first intervention) and 52 (second intervention)|3 completing study were analyzed|||bleeds per 26 weeks|||Number
1385192|NCT01405560|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants|||Number
1385193|NCT01405560|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment.|||Log IU/ml||Standard Deviation|Mean
1385194|NCT01405560|Secondary|Percentage of Participants Achieving Undetectable HCV Ribonucleic Acid (RNA) at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1385195|NCT01405560|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1385196|NCT01405560|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1388734|NCT01369732|Secondary|the Duration of Hospital Stay|Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.|upto 1 month after surgery|||||||
1385197|NCT01405560|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1385198|NCT01405560|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants||95% Confidence Interval|Number
1385199|NCT01405560|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)24|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1385200|NCT01405508|Secondary|Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period.|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|4.5-day Evaluation Period|Safety Population consisting of all subjects who took at least 1 dose of study drug.|||Participants|||Number
1385201|NCT01405508|Secondary|Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.|||Participants|||Number
1385202|NCT01405508|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.|||Participants|||Number
1385203|NCT01405469|Secondary|Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||percentage of treated patients|||Number
1385204|NCT01405469|Secondary|cm Myotomy Length|myotomy length in cm|POEM procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||cm||Standard Deviation|Mean
1385205|NCT01405469|Secondary|Days Duration Hospitalization|participants were followed for the duration of hospital stay, an average of 4 days|days of hospitalization for POEM procedure, an average of 4 days|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||days||Standard Deviation|Mean
1385206|NCT01405469|Secondary|Duration Time Procedure|duration time of POEM procedures in minutes|procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||minutes||Standard Deviation|Mean
1385207|NCT01405469|Secondary|Medication 3 Months After POEM|proton pump inhibitor (PPI) use at 3 months after POEM procedure|3 months||||participants|||Number
1385208|NCT01405469|Secondary|Number of Participants With Procedure-related Adverse Events|procedure-related adverse events per protocol|procedure to 3 months post procedure||||Participants|||Count of Participants
1388735|NCT01369732|Secondary|the Duration of ICU Stay|Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery|||||||
1385209|NCT01405469|Primary|Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||Eckardt Score||Standard Deviation|Mean
1385210|NCT01405469|Secondary|Number of Participants With Reflux Symptoms|Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment|during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment||||participants|||Number
1385211|NCT01405469|Secondary|mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure|esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure|manometry at 3 month after therapy|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||mmHg||Standard Deviation|Mean
1385212|NCT01405456|Secondary|Markers of Immune Activation|MCP-1|6 months||||pg/mL||Standard Error|Mean
1385213|NCT01405456|Secondary|Markers of Systemic Inflammation|IL-6|6 months||||pg/mL||Inter-Quartile Range|Median
1385214|NCT01405456|Secondary|Adiponectin||6 months||||pg/mL||Inter-Quartile Range|Median
1385215|NCT01405456|Secondary|Plasminogen Activator Inhibitor 1||6 months||||ng/mL||Standard Error|Mean
1385216|NCT01405456|Secondary|C-Reactive Protein||6 months||||mg/L||Inter-Quartile Range|Median
1385217|NCT01405456|Secondary|Hemoglobin A1c||6 months||||percentage||Inter-Quartile Range|Median
1385218|NCT01405456|Secondary|Potassium||6 months||||mEq/L||Standard Error|Mean
1385219|NCT01405456|Secondary|Flow Mediated Vasodilation||6 months||||percentage of maximum change||Inter-Quartile Range|Median
1385220|NCT01405456|Secondary|Intramyocellular Lipid||6 months||||percentage of intramyocellular lipid||Inter-Quartile Range|Median
1385221|NCT01405456|Secondary|Liver Fat||6 months||||percentage of intrahepatic lipid||Inter-Quartile Range|Median
1385222|NCT01405456|Secondary|Visceral Adipose Tissue||6 months||||cm^2||Inter-Quartile Range|Median
1385223|NCT01405456|Primary|Insulin Stimulated Glucose Uptake||6 months||||mg/min per μIU/ml||Inter-Quartile Range|Median
1385224|NCT01405313|Secondary|Oxygen Desaturation Index (ODI)|Oxygen desaturation index based on SpO2 measurement of number of dips (number of times per hour of sleep that SpO2 Drops by at least 3% below the basic value) will be recorded, analysed and reported.|One night||||Events per hour||Standard Deviation|Mean
1385225|NCT01405313|Primary|Apnea/Hypopnea Index (AHI)|Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by >90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by >30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.|One night||||Events per hour||Standard Deviation|Mean
1385226|NCT01405196|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1385227|NCT01405196|Secondary|Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) Score at Baseline|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Units on a scale||Standard Deviation|Mean
1385228|NCT01405196|Secondary|Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24|The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1385229|NCT01405196|Secondary|Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1385230|NCT01405196|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1385231|NCT01405196|Secondary|Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoint. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Units on a scale||Standard Error|Mean
1385232|NCT01405196|Secondary|Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state).|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
1385233|NCT01405196|Secondary|Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24|Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question “Considering all the ways your disease affects you, how are you feeling today?” Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||mm||95% Confidence Interval|Least Squares Mean
1385234|NCT01405196|Secondary|Patient Global Visual Analog Scale (VAS) Scores at Baseline|Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question “Considering all the ways your disease affects you, how are you feeling today?” Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).|Baseline|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||mm||Standard Error|Mean
1385235|NCT01405196|Secondary|Percentage of Participants With Normalized Serological Activity|Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.|Baseline up to Week 24|Consistent with the protocol which pre-specified that if the number of participants with abnormal serological activity at baseline were <25% of overall population, data for this outcome measure was not available.||||||
1385236|NCT01405196|Secondary|Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)|Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant’s symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data.|Week 12, 16, 20, 24|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoints. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Percentage of Participants|||Number
1385237|NCT01405196|Secondary|Serum Concentration of PF-04236921|Serum PF-04236921 concentrations over time were summarized.|Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24|"Pharmacokinetic analysis set was the subset of participants from safety analysis set (all participants who received at least 1 dose of investigational product) who provided at least 1 pharmacokinetic concentration. Here, number analyzed signifies those participants who were evaluable at specified time points."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1385238|NCT01405196|Secondary|Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)|Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
1385239|NCT01405196|Secondary|Number of Participants With Potentially Clinically Important Vital Signs Findings|Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight)|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
1385240|NCT01405196|Secondary|Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings|Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product. Here, N (Number of participants analyzed) signifies participants evaluable for this outcome measure for each group respectively.|||Participants|||Number
1385241|NCT01405196|Secondary|Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
1385242|NCT01405196|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
1385243|NCT01405196|Secondary|Number of Participants Who Discontinued Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants who discontinued due to adverse events were reported.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
1385244|NCT01405196|Secondary|Number of Participants With Clinically Significant Laboratory Tests Results|Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL].|Baseline up to Week 52|"Safety population defined as all participants who had at least one dose of investigational product. Here, number analyzed signifies those participants who were evaluable at specified time points."|||Participants|||Number
1385245|NCT01405196|Secondary|Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24|SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant’s general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported|Week 24|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Percentage of participants|||Number
1385246|NCT01405196|Secondary|Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24|BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant’s general health status(range: 0[none] to 3[severe]).|Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Percentage of participants|||Number
1385247|NCT01405196|Secondary|Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24|"SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters Low complement and Leukopenia), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant’s general health status (range: 0[none] to 3[severe])."|Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Percentage of participants|||Number
1385248|NCT01405196|Secondary|Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20|SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant’s general health status(range: 0[none] to 3[severe]).|Week 4, 8, 12, 16, 20|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Percentage of participants|||Number
1385249|NCT01405196|Primary|Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24|SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician’s Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant’s general health status(range: 0[none] to 3[severe]).|Week 24|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Percentage of participants|||Number
1385250|NCT01405027|Secondary|Number of Participants With Adverse Events|Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs|Throughout entire study, at end of treatment and follow up week 24||||participants|||Number
1385251|NCT01405027|Secondary|Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)|"Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs.~Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life."|Baseline, end of treatment, follow-up week 24|The Quality of Life scores are derived from the responses from subjects who completed questionnaires at protocol-scheduled timepoints.|||score||Standard Deviation|Mean
1385252|NCT01405027|Secondary|Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.|Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.|Follow-up week 24|Follow-up SVR includes data collected 10 weeks or greater from last treatment.|||percentage of participants|||Number
1385254|NCT01405027|Primary|Treatment Duration Compliance Rate|The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).|End of treatment up to treatment week 48|Population analyzed represents patients who had a PCR at treatment weeks where expected duration of treatment could have been determined. Subjects who discontinued the study due to Treatment Futility were considered to have 100% treatment duration compliance.|||Percentage of compliance||95% Confidence Interval|Mean
1385255|NCT01404988|Secondary|Self-reported Medication Adherence|Assessed using Morisky medication-taking scale. Higher score corresponds to worse adherence.|6 months from baseline||||participants|||Number
1385256|NCT01404988|Secondary|Adherence to Beta Blockers|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline||||proportion of refill compliance||Inter-Quartile Range|Median
1385257|NCT01404988|Secondary|Adherence to ACE Inhibitors and ARB|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months after baseline||||proportion of refill compliance||Inter-Quartile Range|Median
1385258|NCT01404988|Primary|Medication Adherence (Refill Compliance for All HF Medications)|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline visit||||proportion of refill compliance||Inter-Quartile Range|Median
1385259|NCT01404936|Primary|Participants' Response|Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: > 25 % increase in size of any measurable lesion or appearance of significant new lesions.|After 6 courses (3 months)|Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.|||participants|||Number
1385260|NCT01404923|Primary|Percentage of Improvement of the Total IBSQoL Scores|Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage|Baseline and 6 Months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at lesat one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.|||% of improvement of IBSQoL total scores||Standard Deviation|Mean
1385261|NCT01404923|Primary|Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score|Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.|Baseline and 6 months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at least one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.|||units on a scale||Standard Error|Mean
1385262|NCT01404832|Secondary|Number of Patients Who Had Resolution of Heartburn With Lansoprazole|Resolution of heartburn defined as >50% improvement in symptoms|After 8 weeks of treatment||||participants|||Number
1385263|NCT01404832|Primary|Number of Participants With Eosinophilic Esophagitis||8 weeks||||participants|||Number
1385264|NCT01404650|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Worst toxicity grades per patient were tabulated for select adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.0|Days 1, 8 and 15 of each 21-day cycle plus 30 days after treatment discontinuation.|All participants who received at least one dose of study drug.|||participants|||Number
1385265|NCT01404650|Secondary|Overall Survival (OS)|Evidence of survival was obtained by clinic visit or telephone contact from the time of first dose until death from any cause.|Every 3 months until patient death or lost to follow-up, for up to 4 years.|All 25 patients who received treatment were included in the analysis of overall survival.|||months||95% Confidence Interval|Median
1385266|NCT01404650|Secondary|Response Rate (RR)|Defined as the proportion of complete and partial responses, assessed per RECIST v1.1. Complete response (CR) defined as a disappearance of all lesions; partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|At 6 and 12 weeks then every 9 weeks thereafter until progressive disease or intolerable toxicity, for up to 4 years.|Of 25 patients enrolled, 4 patients were not evaluable for response due to treatment discontinuation prior to first disease evaluation.|||percentage of participants|||Number
1385267|NCT01404650|Primary|Progression-free Survival (PFS)|Measured from time of randomization until objective tumor progression or death; assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions.|At 6 and 12 weeks then every 9 weeks thereafter until progression or intolerable toxicity, up to 4 years.||||months||95% Confidence Interval|Median
1385268|NCT01404611|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study (up to 22 days)||||days||95% Confidence Interval|Median
1385269|NCT01404572|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.||||||
1385270|NCT01404572|Secondary|Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Participants|||Number
1385271|NCT01404572|Secondary|Number of Participants With Abnormal Findings on Electrocardiograms||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.||||||
1385272|NCT01404572|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.||||||
1385273|NCT01404572|Primary|Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Standard Deviation|Mean
1385274|NCT01404572|Secondary|Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Standard Deviation|Mean
1385275|NCT01404572|Secondary|Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Full Range|Median
1385276|NCT01404572|Primary|Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Full Range|Median
1385277|NCT01404559|Primary|Bioenergetics Between Feet Components 21 Days After Fitting Prostheses|Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.|21 days total (7days per prosthetic foot condition)||||ml O2/kg/min||Standard Deviation|Mean
1385278|NCT01404559|Primary|Obstacle Course Completion Time|Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.|21 days total (7days per prosthetic foot condition)||||seconds||Standard Deviation|Mean
1385279|NCT01404429|Secondary|Proportion Who Withdrew Due to Intolerance||3 months||||participants|||Number
1385280|NCT01404429|Secondary|Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)||3 months|||||||
1385281|NCT01404429|Secondary|Proportion of Patients Who Withdrew Because of Any Cause||3 months||||participants|||Number
1385282|NCT01404429|Primary|Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)||3 months||||participants|||Number
1385385|NCT01402869|Secondary|Delta Methemoglobin Blood Level|Change in percentage of methemoglobin in blood from baseline level to peak level|From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours|Per protocol|||percentage of methemoglobin in blood||Standard Deviation|Mean
1385283|NCT01404429|Primary|Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline|DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity|12 weeks||||units on a scale||Standard Deviation|Mean
1385284|NCT01404260|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .|The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured|Efficacy analysis, including PFS will be based on intent to treat (ITT) population.. ITT population includes all the randomised patients who receive at least one dose of study treatment with at least one baseline data of volume of plaque and at least one data after treatment.|||months||95% Confidence Interval|Median
1385285|NCT01404234|Secondary|Adverse Event Rates Adjusted for Study Duration|Adverse events occurring in ≥ 5% of participants adjusted for study duration were summarized. The adjustment was made by using a standardized rate calculated as the sum of study duration across patients divided by 28 for the total number of patient months. Rate calculations presented are the number of adverse events (AEs) per patient month.|Baseline to Day 168|Full Analysis Set|||AEs (per patient month)|||Number
1385286|NCT01404234|Secondary|Percentage of Participants With Study-drug Induced Bronchospasm|Study-drug induced bronchospasm (airway reactivity) was assessed at the baseline visit as the percent change in FEV1 from the pretreatment measurement to 30 minutes following treatment for subjects ≥ 6 years or as from the Investigator's assessment for subjects < 6 years.|Pretreatment at Baseline to 30 minutes following treatment|Full Analysis Set|||percentage of participants|||Number
1385287|NCT01404234|Secondary|Time to Pulmonary Exacerbation|The median days to first pulmonary exacerbation was summarized using Kaplan-Meier (KM) summary statistics.|Baseline to Day 168|Full Analysis Set|||days||95% Confidence Interval|Median
1385288|NCT01404234|Secondary|Percentage of Participants With Pulmonary Exacerbations|Pulmonary exacerbations were defined as respiratory hospitalizations or discrete courses of non-study IV/inhaled antipseudomonal antibiotics. Use of oral antibiotics alone for respiratory signs or symptoms was considered to be representative of milder clinical events and, therefore, was not included in the definition of pulmonary exacerbations.|Baseline to Day 168|Full Analysis Set|||percentage of participants|||Number
1385289|NCT01404234|Secondary|Number of Days Participants Were Hospitalized Due to a Respiratory Event|The average number of days hospitalized due to a respiratory event, among the 11 participants who were hospitalized for respiratory event, was reported.|Baseline to Day 168|Full Analysis Set|||days||Standard Deviation|Mean
1385290|NCT01404234|Secondary|Percentage of Participants Hospitalized at Least Once Due to a Respiratory Event||Baseline to Day 168|Full Analysis Set|||percentage of participants|||Number
1385291|NCT01404234|Secondary|Percentage of Participants Who Used Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (IV, inhaled, oral, IV/inhaled, IV/inhaled/oral) was summarized (number and percent) for all subjects.|Baseline to Day 168|Full Analysis Set|||percentage of participants|||Number
1385292|NCT01404234|Secondary|Change in Pseudomonas Aeruginosa (PA) Sputum Density|The change in PA sputum density (log10 colony-forming units per gram [cfu/g]) was assessed at the end of each 28-day AZLI treatment course.|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.|||log10 CFU/g||Standard Deviation|Mean
1385293|NCT01404234|Secondary|Change From Baseline in CFQ-R Respiratory Symptoms Scale (RSS) Score in Subjects Aged ≥ 6 Years|"The change in CFQ-R RSS score was assessed at the end of each 28-day AZLI treatment course.~The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.|||units on a scale||Standard Deviation|Mean
1385294|NCT01404234|Secondary|Change From Baseline in FEV1 % Predicted in Subjects Aged ≥ 6 Years|"The change in FEV1 % predicted was assessed at the end of each 28-day AZLI treatment course.~FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.|||percentage of FEV1 % predicted||Standard Deviation|Mean
1385295|NCT01404234|Primary|Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons|Participants who discontinued study drug due to safety or tolerability reasons were defined as those with “Adverse Event (AE)/Safety or Tolerability” on the Study Drug Completion electronic case report form as the reason for early discontinuation. The 95% confidence interval (CI) was calculated using the exact binomial method.|Baseline to Day 168|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study medication) who completed the study or discontinued study drug due to safety or tolerability reasons were analyzed. Two participants voluntarily withdrew from the study prior to completion (not due to AEs/safety or tolerability reasons).|||percentage of participants||95% Confidence Interval|Number
1385296|NCT01404208|Secondary|Clinical Global Impression-Severity (CGI-Severity)|The Clinical Global Impression-Severity is a 7-point clinician rating of illness severity, with a score of 0 indicating no illness and a score of 6 indicating extremely severe symptoms. Because the secondary outcome was the change in score from randomization to post treatment, a more negative score indicates a greater reduction in symptom severity.|Change from Randomization Point to Post Treatment||||Change in score from randomization||Standard Deviation|Mean
1385297|NCT01404208|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity.|Change from Score at Randomization to Post Treatment||||Change in score from randomization||Standard Deviation|Mean
1385298|NCT01404078|Secondary|Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics||8 weeks|||||||
1385300|NCT01404078|Primary|BLOOD PRESSURE LIPIDS|Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose.|8 weeks||||mmHG||95% Confidence Interval|Mean
1385301|NCT01404039|Primary|Change in Motor Cortex Excitability MEP Amplitude|"We aim to assess the effects of the intervention (ML, SL, OT and MI) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention.~For ML: MEP will be measured before and after each ML sessions in the same subject (crossover design - ML sighted/MLblind/ML control).~For SL: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).~For OT: MEP will be measured before and after the treatment session in the each groups (parallel - 1 session per group).~For MI: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group)."|after each intervention|"ML: crossover design - ML sighted/MLblind/ML control. 15 patients were enrolled, but one participant dropped-out after the first intervention - participants with available data: 14.~SL: parallel design - SL sighted/SLblind/Sactivation/SLcontrol. OT: parallel design - OT real and OT control. MI: parallel design - MI real and MI control."|||microV||Standard Deviation|Mean
1385302|NCT01403987|Secondary|Readmission and Mortality Rates|Percentage of patients in each arm that were either readmitted within 30 days or died within 90 days (ie a combined endpoint of either/or readmission or death)|18 months||||percentage of patients|||Number
1385303|NCT01403987|Secondary|Improvement in Guideline Adherence|Improvement in adherence to AASLD guidelines is summarized as yes or no improvement based on investigator chart review performed prior to and after the intervention. This is not a measure of resident reporting adherence but rather investigator interpretation of patient care and whether care was in line with published guidelines.|18 months||||percentage of participants|||Number
1385304|NCT01403987|Primary|Score Out of Total Possible 25 on a Likert Scale.|"Primary outcome is quantified by summation of Likert scale responses to five questions assessing for comfort level in caring for and managing inpatients with ascites. The scale ranges from strongly disagree, which is assigned a value of 1, to strongly agree, assigned a value of 5. The summation scores will therefore range from 5 to 25 points out of a total of 25 possible points. The post-intervention scores will be compared between groups using a multiple regression model with terms for treatment, baseline summary scores, and other baseline demographic variables as needed."|6 months|Those who provided both baseline and follow up surveys|||units on a Likert scale (maximum is 25)||Standard Deviation|Mean
1385305|NCT01403805|Other Pre-specified|Died Before Oral Care Starting|Number of resident died before the start of oral care|This participant was died before treatment, Day 1|"This participant was determined as Not Completed due to Died before oral care starting. We excluded this participant from analysis for outcome measure."|||participants|||Number
1385306|NCT01403805|Other Pre-specified|Reject Vaccine|Number of resident to reject vaccine|These participants rejected vaccine before treatment, Day 1|"These participants were determined as Not Completed due to Reject vaccine. We excluded these participants from analysis for outcome measure."|||participants|||Number
1385307|NCT01403805|Other Pre-specified|Reject Oral Care|Number of resident to reject oral care|This participant rejected oral care before treatment, Day 1|"This participant was determined as Not Completed due to Reject oral care. We excluded this participant from analysis for outcome measure."|||participants|||Number
1385308|NCT01403805|Other Pre-specified|Leaving Nursing Home|Numer of resident for leaving nursing home|These participants were followed for the duration of nursing home stay, an average of 22 weeks.|"These participants were determined as Not Completed due to Leaving nursing home. We excluded these participants from analysis for outcome measure."|||participants|||Number
1385309|NCT01403805|Secondary|Death From Pneumonia|Number of participants for the death from pneumonia|1 year||||participants|||Number
1385310|NCT01403805|Primary|Number of Participants With Pneumonia|Number of Participants with Pneumonia sufferers|1 year||||participants|||Number
1385311|NCT01403441|Secondary|Delis-Kaplan Executive Function System (D-KEFS) Composite Score|D-KEFS is a neurocognitive assessment of executive function. The composite score is derived from scores on tests that include Trails A, Color Word Interference, Verbal Fluency, Sorting, WAIS III Digit Span, and CVLT II Long Delay Free Recall. The scores are reported as deviation from a mean of 10, with a standard deviation of 3. A score of 7 is one standard deviation below the mean, while a score of 13 is 1 standard deviation above the mean. Higher numeric outcomes reflect better performance on the test, lower values reflect poorer performance. Results reflect scores at baseline, and 12 month observation period following Cyberknife System|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1385312|NCT01403441|Secondary|Clinical Global Impression - Severity (CGI-S) at Baseline and 12 Months|The CGI-S assess the overall severity of depression over the 12 month observation period following Cyberknife System. It is rated from 1 (well or remitted) to 7 (severely ill, among the most depressed).|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
1385313|NCT01403441|Secondary|Hamilton Depression Rating Scale (HDRS) - 17 Item|The HDRS is a rating scale measures the severity of depressive symptoms. The scale consists of 17 symptoms with severity anchors that are scored from 0 to 4. The maximum score (most severe depression) is 68, the lowest (no depressive symptoms) is 0.|Baseline and 12 months|Patients with Bipolar disorder in the depressive phase that have not responded to available treatments|||units on a scale||Standard Deviation|Mean
1385314|NCT01403441|Primary|Serious Adverse Event|An event that required hospitalization due to an unanticipated worsening of the subjects bipolar disorder.|Baseline and 12 months.|Patients with bipolar disorder in the depressive phase who have not responded to any available treatment|||event|||Number
1385315|NCT01403376|Secondary|Immunoglobulin Levels||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||g/L||Standard Deviation|Mean
1385316|NCT01403376|Secondary|Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||ratio post/pre vaccination||90% Confidence Interval|Geometric Mean
1388736|NCT01369732|Secondary|the Duration of Mechanical Ventilation|Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery|||||||
1385317|NCT01403376|Secondary|Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 4-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||percentage of participants||90% Confidence Interval|Number
1385318|NCT01403376|Secondary|Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 2-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||percentage of participants||90% Confidence Interval|Number
1385319|NCT01403376|Primary|Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination|"For each viral strain (H1N1, H3N2, and B), the antibody titer, level of antibodies in blood sample when exposed to antigen, was calculated as the mean of two replicates. If the titer was below or above the limit of detection, the threshold value was used.~The percentage of participants achieving a titer of 40 or more, as well as the 90% confidence interval (CI) using normal approximation were calculated for each strain and treatment group."|28 days post vaccination|Per-protocol population: Enrolled and vaccinated participants with antibody assessments at Day 28, but excluding those with important events/deviations potentially impacting analysis (multiple sclerosis relapse, poor compliance to treatment, interfering concomitant drug). Participants were considered according to the treatment actually received.|||percentage of participants||90% Confidence Interval|Number
1385320|NCT01403194|Secondary|Change in Level of Lipids||baseline, 3 months|Only one participant returned for the 3 month visit.||||||
1385321|NCT01403194|Secondary|Change in Level of Fasting Insulin||baseline, 3 months|Only one participant returned for the 3 month visit.||||||
1385322|NCT01403194|Primary|Change in Level of Fasting Glucose||baseline, 3 months|Only one participant returned for the 3 month visit.||||||
1385323|NCT01403116|Secondary|% of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90|Percentage of Oral TU treated patients who reached study day 90 and had a maximum serum T concentrations (Cmax) values greater than 1500 ng/dL(objective to meet <15%).|90 days|Percent of oral TU treated subjects with Cmax >1500 ng/dL at Study Day 90|||Participants|||Count of Participants
1385324|NCT01403116|Primary|Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL|The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL|Following 90 days of treatment|Intent to treat population|||percentage of partipants||95% Confidence Interval|Geometric Mean
1385325|NCT01403090|Primary|Safety|Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.|30 days||||participants|||Number
1385326|NCT01403051|Secondary|The Changes From Baseline in iPTH to Weeks 24 and 48|iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."|||pg/mL||Inter-Quartile Range|Median
1385327|NCT01403051|Secondary|The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48|Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline].|Weeks 0, 4, 12, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=78 and 86 for changes at week 4, n=77 and 85 for changes at week 4, n=76 and 84 for changes at week 24, n=69 and 80 for changes at week 48."|||cells/mm^3||Inter-Quartile Range|Median
1385328|NCT01403051|Secondary|The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48|"Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Fractional Excretion of Phosphate (in %) is defined as:~[Urine Phosphate x Serum Creatinine] / [Urine Creatinine x Serum Phosphate] x 100%"|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=58 and 70 for changes at week 24, n=59 and 69 for changes at week 48."|||percent||Inter-Quartile Range|Median
1385329|NCT01403051|Secondary|The Changes From Baseline in Fasting LDL to Weeks 24 and 48|Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=70 and 72 for changes at week 24, n=65 and 67 for changes at week 48."|||mg/dL||Inter-Quartile Range|Median
1385330|NCT01403051|Secondary|The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48|Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=74 and 80 for changes at week 24, n=68 and 73 for changes at week 48."|||mg/dL||Inter-Quartile Range|Median
1385331|NCT01403051|Secondary|The Changes From Baseline in HOMA-IR to Weeks 24 and 48|Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=69 and 73 for changes at week 24, n=64 and 69 for changes at week 48."|||HOMA-IR||Inter-Quartile Range|Median
1385332|NCT01403051|Secondary|The Changes From Baseline in CTX to Weeks 24 and 48|CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."|||ng/mL||Inter-Quartile Range|Median
1385624|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||ml||Standard Deviation|Mean
1385333|NCT01403051|Secondary|The Changes From Baseline in P1NP to Weeks 24 and 48|P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."|||ng/mL||Inter-Quartile Range|Median
1385334|NCT01403051|Secondary|The Changes From Baseline in sCD14 to Weeks 24 and 48|Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=68 and 68 for changes at week 24, n=62 and 63 for changes at week 48."|||log10 ng/mL||Inter-Quartile Range|Median
1385335|NCT01403051|Secondary|The Changes From Baseline in IL-6 to Weeks 24 and 48|Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=66 and 68 for changes at week 24, n=58 and 62 for changes at week 48."|||log10 pg/mL||Inter-Quartile Range|Median
1385336|NCT01403051|Secondary|The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48|"Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Total 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL"|Weeks 0, 24, and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=71 and 74 for changes at week 24, n=65 and 68 for changes at week 48."|||ng/mL||Inter-Quartile Range|Median
1385337|NCT01403051|Secondary|Number of Participants With Primary Adverse Events|Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table|From first study treatment to week 48|All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.|||participants|||Number
1385338|NCT01403051|Secondary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine|The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan|Weeks 0 and 48|This analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.|||percentage change||Inter-Quartile Range|Median
1385339|NCT01403051|Primary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip|The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)|Weeks 0 and 48|The primary analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.|||percentage change||Inter-Quartile Range|Median
1385340|NCT01402986|Secondary|Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change||Standard Error|Mean
1385341|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home|Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change||Standard Error|Mean
1385342|NCT01402986|Secondary|Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53|Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for IC was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
1385343|NCT01402986|Secondary|Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for FVC was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
1385344|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53|Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for FEV6 was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
1385576|NCT01401101|Primary|PTSD Symptoms|same as baseline and 6 months|12 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|||CAPS scores||95% Confidence Interval|Mean
1385345|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53|Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms. Baseline for FEV1 was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
1385346|NCT01402986|Secondary|Change From Baseline in Overall Activity Limitations at Week 53|There were 3 activity limitation questions in the ASMA diary. All activity questions were scored from 0 to 4 and averaged, where the higher score indicated greater limitation. Activity limitation scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1385347|NCT01402986|Secondary|Change From Baseline in Percentage of Nighttime Awakening at Week 53|Scores for nighttime awakenings were generated based on the single item (question 5) that had a dichotomous response option (YES/NO). Nighttime awakenings were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated with data from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change||Standard Deviation|Mean
1385348|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup chronic OCS use. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385349|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Atopic and Non-atopic asthma status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385350|NCT01402986|Secondary|Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1385351|NCT01402986|Secondary|Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1385352|NCT01402986|Secondary|Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups|Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||Percent change||Standard Error|Mean
1385386|NCT01402869|Secondary|Time to Peak Methemoglobin Blood Levels|The length of time between the administration of local anesthetic (Prilocaine and Lidocaine Groups) or start of restorative dental procedures (No local anesthetic Group) and the time at which the maximum methemoglobin blood level is observed.|Measured at 10 second intervals during dental treatment for an average of 2 hours|per protocol|||minutes||Standard Deviation|Mean
1385353|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup baseline peripheral blood eosinophil count. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385354|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status|Severe AER was assessed based on AER data up to Week 53. An asthma exacerbation is a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 days. It was considered resolved 7 days after last dose of OCS administered (10 days after injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup Th2 status. Th2-high include participants who had IgE >100 IU/mL and blood eosinophils >=0.14*10^9/Liter. Th2 low would include participants who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385355|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup FEV1 reversibility. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385356|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER evaluated by subgroup baseline serum periostin. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385357|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385365|NCT01402986|Secondary|Severe Annual Asthma Exacerbation Rate (AER)|Severe annualized AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids is administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.|||AER events/person-year||95% Confidence Interval|Number
1385358|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385359|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup baseline FEV1 reversibility >=12% and <12%. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385360|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385361|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Th2 status. Th2-high included those participants who had immunoglobulin E (IgE) >100 international unit per milliliter (IU/mL) and blood eosinophils >= 0.14 * 10 power 9 per Liter. Th2 low would include those participants who do not meet Th2 high status. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385362|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline serum periostin greater than or equal to (>=) or less than (<) median, >= or < 25th percentile and >= or < 75th percentile. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
1385363|NCT01402986|Secondary|Time to First Severe Exacerbation Through Week 53|Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.|||days||95% Confidence Interval|Median
1385364|NCT01402986|Secondary|Time to First Exacerbation Through Week 53|Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.|||days||95% Confidence Interval|Median
1385366|NCT01402986|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab|Immunogenicity assessment included determination of anti-drug (tralokinumab) antibodies in serum samples. ADA positive was defined as a titer greater than or equal to (>=13) at any point in the study. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 75|"The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage of participants|||Number
1385367|NCT01402986|Secondary|Observed Serum Tralokinumab Concentration at Week 53|Tralokinumab concentrations that were below limit of quantification (LOQ) of the pharmacokinetic (PK) assay (LOQ = 0.500 microgram per milliliter [mcg/mL]) were replaced by LOQ/2 = 0.250 mcg/mL; results were reported to 3 significant figures level of precision. Observed serum tralokinumab concentration at Week 53 was reported.|Week 53|"The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here N signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||microgram per milliliter||Standard Deviation|Mean
1385368|NCT01402986|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 75 that were absent before treatment or that worsened relative to pre-treatment state. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 75|The safety population included all participants who received any investigational product and had safety data available for analysis.|||participants|||Number
1385369|NCT01402986|Secondary|Change From Baseline in Rescue Medication Use at Week 53|Rescue medication use was collected from 3 questions: daytime use in response to symptoms (question 3), daytime prophylactic use (question 4) and nighttime use (question 7). Rescue medication use questions were first assessed using a dichotomous response option (YES/NO). If the participants reported YES, there was a subsequent question about the number of times rescue medication was used (questions 3a, 4a, and 7a). Daily average scores were summarized each week for all participants with at least 4 non-missing records each week. Days with no reported rescue medication use were represented as 0 and included in the calculation with participants who reported yes and completed questions 3a, 4a and 7a. The baseline scores were calculated from Day -7 to Day -1. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||use per day||Standard Deviation|Mean
1385370|NCT01402986|Secondary|Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53|There were 3 symptom questions in the ASMA diary: daytime frequency (question 1), daytime severity (question 2) and nighttime severity (question 6). All symptom questions were scored from 0 to 4 averaged, where a higher score indicated greater frequency or severity. Daily Asthma symptom scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1385371|NCT01402986|Secondary|Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1385372|NCT01402986|Secondary|Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems) that reflects increasing levels of difficulty. The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 53|The ITT population included all participants who were randomized into the study.|||participants|||Number
1385373|NCT01402986|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1385374|NCT01402986|Secondary|Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1385375|NCT01402986|Secondary|Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters per minute||Standard Error|Mean
1385376|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home|Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
1385377|NCT01402986|Secondary|Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53|Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
1385378|NCT01402986|Secondary|Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FEV1 and FVC at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Ratio of FEV1/FVC was analysed. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage of ratio||Standard Error|Mean
1385379|NCT01402986|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
1385380|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53|Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
1385381|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53|Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
1385382|NCT01402986|Primary|Annual Asthma Exacerbation Rate (AER)|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids (OCS) is administered (10 days after administration of an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for ‘Placebo, Q2W’ and ‘Placebo, Q2/4W’ arms.|Week 1 up to Week 53|The intent-to-treat (ITT) population included all participants who were randomized into the study.|||AER events/person-year||95% Confidence Interval|Number
1385383|NCT01402947|Primary|Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ng/ml||Standard Deviation|Mean
1385384|NCT01402947|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ng*h/ml||Standard Deviation|Mean
1385387|NCT01402869|Primary|Peak Methemoglobin Blood Levels|The maximum percentage of methemoglobin in blood|Measured at 10 second intervals during dental treatment for an average of 2 hours|Per protocol|||percentage of methemoglobin in blood||Standard Deviation|Mean
1385389|NCT01402817|Primary|Disease Response|To estimate the disease control rate (SD, PR, CR) with Sutent® in patients with neurofibromas (NF1). Tumor response criteria are determined by changes in size using all 3 dimensional measurements: width (W), transvers (T) , and length (L) measurements. Partial Response: ≥20% decrease in the sum of the products of the three perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements.Stable Disease (SD): Neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for PR (taking as reference the initial baseline measurements), nor sufficient increase in a single target lesions to qualify for PD, (taking as reference the smallest disease measurement since the treatment started).Progressive Disease (PD): 40% or more increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed.|6 months||||percentage of subjects||95% Confidence Interval|Number
1385390|NCT01402700|Primary|Major Adverse Event Rate at 9 Months|The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.|9 months||||percentage of participants|||Number
1385391|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue|Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one’s ability to carry out daily activities, including the ability to work effectively and to function at one’s usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.|Baseline, 1 month, 2 months and 3 months||||units on a scale||Standard Deviation|Mean
1385392|NCT01402570|Primary|Steps Per Day|Count of steps per day using activity monitor worn on upper arm.|Baseline, 1 month, 2 months and 3 months||||steps per day||Standard Deviation|Mean
1385393|NCT01402570|Primary|Sleep Efficiency|The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.|Baseline, 1 month, 2 months and 3 months||||units on a scale||Standard Deviation|Mean
1385394|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning|Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.|Baseline, 1 month, 2 months and 3 months||||units on a scale||Standard Deviation|Mean
1385395|NCT01402427|Secondary|Subjective Pain|Analysis of the rates of signiﬁcant pain deﬁned as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.|Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
1385396|NCT01402427|Secondary|Contrast Volume||The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.||||milliliter||Inter-Quartile Range|Median
1385397|NCT01402427|Secondary|Fluoroscopic Time||Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.||||minutes||Inter-Quartile Range|Median
1385398|NCT01402427|Secondary|Procedural Time||Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.||||minutes||Inter-Quartile Range|Median
1385399|NCT01402427|Secondary|Rate of Vasodilator Use||Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
1385400|NCT01402427|Secondary|Rate of Code Breaks|Code break: a composite of access site conversion and unplanned use of vasodilators.|Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
1385401|NCT01402427|Primary|Rate of Access Site Conversions||Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
1385402|NCT01402375|Post-Hoc|Time to Follow up|Median time to contact patients for data collection, measured from discharge to time contacted|up to 48 hours||||hours||Inter-Quartile Range|Median
1385403|NCT01402375|Post-Hoc|50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score||2 hours||||Participants|||Count of Participants
1385404|NCT01402375|Secondary|Overall Satisfaction With the Pain Medicine|Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication.|24 hrs|Any number analyzed that does not equal the overall number of participants is due to missing data|||Participants|||Count of Participants
1385405|NCT01402375|Primary|Difference in Pain Intensity Score Before and After Last Dose.|"Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken."|2 hrs||||units on a scale||Standard Deviation|Mean
1385445|NCT01402063|Primary|Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation|"MRI response evaluated by RANO criteria~Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response.~Partial Response (PR): Decrease of > 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan.~Progression (P): A > 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT."|Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.||||participants|||Number
1385406|NCT01402284|Secondary|Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance|Response is assessed by the International Myeloma Working Group Criteria. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains (FLC). Complete response is negative immunofixation on serum, and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Stringent complete response (sCR) is normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. Near complete response (nCR) is the absence of myeloma protein on electrophoresis, independent of immunofixation status. Very good partial response (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24h. Overall response rate (ORR) is patients who attained a partial response (PR) (≥50% reduction of serum M-protein and reduction in 24h urinary M-protein) or better (BoR) response.|up to 2 years|*Six patients withdrew from the study, four due to non-compliance and two to continue treatment at another institution. `One patient refused to have a bone marrow biopsy procedure and one patient withdrew due to non-compliance. CR (n=0) after 8 cycles.|||percentage of participants||95% Confidence Interval|Number
1385407|NCT01402284|Secondary|Rate of Minimal Residual Disease (MRD) by Flow Cytometry|Response is assessed by the International Myeloma Working Group Criteria. Complete response is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains. Immunophenotyping is performed by multi-parametric flow cytometry.|Day 100||||percentage of participants||95% Confidence Interval|Number
1385408|NCT01402284|Secondary|Cluster of Differentiation 138 (CD138) + Plasma Cells Gene Expression Profiling on Pre and Post Carfilzomib Exposure Bone Marrow Samples|Cluster of differentiation 138+ (CD138)+ plasma cells purified from bone marrow aspirates to identify potential markers of early progression. Changes in selected genes were confirmed by quantitative polymerase chain reaction (PCR) if suggested to be related to risk of progression to multiple myeloma.|Cycle 1 Day 1, an average of 28 days ± 2 days|Data were not collected due to lack of financial resources.||||||
1385409|NCT01402284|Secondary|Overall Survival (OS) Rate|OS is defined as the time of start of treatment to death from any cause.|up to 6 months||||percentage of participants||95% Confidence Interval|Number
1385410|NCT01402284|Secondary|Percentage of Responders With Duration of Response (DOR) at 48 Months|Response is assessed by the International Myeloma Working Group Criteria. DOR is measured from the time measurement criteria are met for a partial response or better until first date that recurrent or progressive disease is objectively documented. Partial response is ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24h. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.|48 months||||percentage of participants||95% Confidence Interval|Number
1385411|NCT01402284|Secondary|Progression Free Survival (PFS) at 48 Months|PFS is defined as time of start of treatment to time of progression or death, whichever occurs first. Response is assessed by the International Myeloma Working Group Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|48 months||||percentage of participants||95% Confidence Interval|Number
1385412|NCT01402284|Secondary|Overall Response Rate|Response is assessed by the International Myeloma Working Group Criteria. Patients who attained a partial response or better (BoR) response by the end of induction. Partial response is ≥50% reduction of serum M-protein and reduction in 24h urinary M-protein.|48.3 months||||percentage of participants||95% Confidence Interval|Number
1385413|NCT01402284|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 years and 9 months and 2 days||||Participants|||Count of Participants
1385414|NCT01402141|Primary|Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo)|"Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size was measured in study visit 1(0 week) and visit 3(12 week).~Percentage change in histamine-induced wheal size calculations were calculated by the formula ((12weeks - 0weeks) * 100/0weeks).~Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size compared with placebo."|12weeks|per protocol analysis|||participants|||Number
1385415|NCT01402141|Secondary|Changes in Eosinophil Cationic Protein(ECP)|Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||μg/L||Standard Deviation|Mean
1385416|NCT01402141|Secondary|Changes in Eosinophil|Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||Percentage of WBCs(white blood cells)||Standard Deviation|Mean
1385417|NCT01402141|Secondary|Changes in Interleukin-4|Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||pg/ml||Standard Deviation|Mean
1385450|NCT01402011|Secondary|Disabilities of the Arm Shoulder and Hand Questionnaire|http://www.dash.iwh.on.ca/assets/images/pdfs/DASH_quest06.pdf 30 questions assessing ability to use shoulder in everyday activities, each question scored 1 to 5, where one is normal, no problem and five is unable to perform. No data was collected at 9 months. The score ranges from 30 to 150. Higher scores represent worse outcomes.|20 minutes before the first injection and at 3 months||||units on a scale||Standard Deviation|Mean
1385451|NCT01402011|Secondary|Physical Examination of the Shoulder Scale|From Steven W. Brose, DO, Michael L. Boninger, MD, Bradley Fullerton, MD, Thane McCann, MD, From: Jennifer L. Collinger, BSE, Bradley G. Impink, BSE, Trevor A. Dyson-Hudson, MD Shoulder ultrasound abnormalities, physical examination findings, and pain in manual wheelchair users with spinal cord injury. Arch Phys Med Rehabil 2008 Nov; 89:2086-93, appendix 1 12 parameters of shoulder examination: Biceps tendon/bicipital groove tenderness, Supraspinatus tendon/greater tuberosity tenderness Acromioclavicular joint tenderness Resisted external rotation. Resisted internal rotation. Supraspinatus test. Painful Arc Test. Neer impingement sign. Hawkins-Kennedy impingement sign. O’Brien Active Compression Test for AC Joint Pathology O’Brien Active Compression Test for Labral Pathology impingement sign. each test scored 0 = no pain, 1 = tenderness, 2 = pain. All 12 scores added. Range 0-24. Higher scores = more pathology|20 minutes before first injection on first day of patient visit and at 3 months||||units on a scale||Standard Deviation|Mean
1385452|NCT01402011|Secondary|Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale|"From Brose et al. shoulder ultrasound abnormalities, physical examination findings, and pain in manual wheelchair users with spinal cord injury Arch Phys Med Rehabil 2008 Nov, 89: 2086-93 appendix 2. rates biceps tendinopathy (0-6), supraspinatus tendinopathy (0-5), greater tuberosity the cortical surface (0-3), dynamics supraspinatus impingement (0-3), dynamic subscapularis/ biceps/ coracoid impingement (0-3). The total score ranged from 0 to 20 with higher scores indicating a worse outcome. The change was calculated by taking the final score - the baseline score."|20 minutes before first injection on first day of patient visit and at on average 9.4 months|Three of the 25% dextrose in ligaments and tendons group did not show up for their ultrasound appointment at nine months.|||units on a scale||Standard Deviation|Mean
1385453|NCT01402011|Primary|Change From Baseline in Maximum Pain Score at 9 Months|Participants were asked about pain at rest, at work, doing sports. The maximum pain reported on a scale ranging from 0 (no pain at all) to 10 (extreme pain) was recorded for each participant. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 9 months.|baseline and 9 months||||units on a scale||Standard Deviation|Mean
1385454|NCT01402011|Primary|Change From Baseline of Visual Analog Pain Scale at 3 Months|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 3 months. VAS scale is from 0 = no pain to 10 = maximum pain|baseline and three months||||units on a scale||Standard Deviation|Mean
1385455|NCT01402011|Primary|Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. The maximum pain level among the 3 different activities was recorded.|20 minutes before first injection on first day of patient visit||||units on a scale||Standard Deviation|Mean
1385456|NCT01401959|Secondary|The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety|A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.|Weekly during each 21 day cycle and for 30 days after completion of protocol-specific treatment. After that patients were followed every 3 months for up to 2 years.|All patients who receive at least one dose of treatment.|||Participants|||Count of Participants
1385457|NCT01401959|Secondary|Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility|Examines the feasibility of administering 6 cycles (21 days per cycle) of eribulin without toxicity or disease worsening following standard neoadjuvant chemotherapy and surgery.|up to 18 weeks|All patients who received at least one dose of treatment|||Participants|||Count of Participants
1385458|NCT01401959|Primary|Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy|The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|Patients who receive at least one dose of treatment|||percentage of patients||95% Confidence Interval|Number
1385459|NCT01401907|Other Pre-specified|Survival||from date of randomization until date of death, assessed up to 3 years||2018-12-31|12/2018||||
1385460|NCT01401907|Other Pre-specified|Additional Resource Utilization|hospital admissions, hospice utilization emergency room admissions intensive care unit admissions resuscitation attempt|from date of randomization until date of death, assessed up to 3 years||2018-12-31|12/2018||||
1385461|NCT01401907|Secondary|Coping (Brief Cope)|compare coping between study arms|Week-12 and Week-24|||||||
1385462|NCT01401907|Secondary|Code Status Documentation|examine rates and timing of code status documentation|study participants will be followed until death or for a minimum of 2 years after enrollment||2018-12-31|12/2018||||
1385463|NCT01401907|Secondary|Health Care Costs||study participants will be followed until death or for a minimum of 2 years after enrollment||2018-12-31|12/2018||||
1385464|NCT01401907|Secondary|Resource Utilization at the End of Life (EOL)|chemotherapy utilization at the EOL hospice utilization (enrollment rate and length of stay)|study participants will be followed until death or for a minimum of 2 years after enrollment||2018-12-31|12/2018||||
1385500|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
1385465|NCT01401907|Secondary|Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer|We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.|12 and 24 weeks|Proportion of caregiver goal is cure at week-12 and week-24. Please note the number of participants reflect those who completed the Perception of Treatment and Prognosis Questionnaire at week-12 and week-24, which explains the discrepancy with the participants flow.|||Participants|||Count of Participants
1385466|NCT01401907|Secondary|Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)|We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms|Week 12 and Week 24|Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.|||units on a scale||95% Confidence Interval|Mean
1385467|NCT01401907|Secondary|Family Caregiver Quality of Life as Measured by the SF-36|The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.|Week-12 and Week-24|Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.|||units on a scale||95% Confidence Interval|Mean
1385468|NCT01401907|Secondary|Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer|We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.|Week12 and Week 24|The different rows reflect analyses at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the Perception of Treatment and Prognosis Questionnaire at these time points (study completers), which explains the discrepancy with the flow chart.|||Participants|||Count of Participants
1385469|NCT01401907|Secondary|Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale|The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.|Week-12 and Week-24|The two rows examine outcomes at two different time points week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.|||Participants|||Count of Participants
1385470|NCT01401907|Secondary|Functional Assessment of Cancer Therapy (Quality of Life Measure)|The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.|24 weeks|The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm)|||units on a scale||95% Confidence Interval|Mean
1385471|NCT01401907|Primary|Functional Assessment of Cancer Therapy (Quality of Life Measure)|The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study|12 weeks||||units on a scale||95% Confidence Interval|Mean
1385472|NCT01401842|Secondary|Dynamic Lumbar Extension Muscular Endurance at 11 Weeks|Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for this outcome (n = 11 stabilization arm; n = 18 strengthening arm).|||repetitions||Standard Error|Mean
1385473|NCT01401842|Secondary|Isometric Core Muscular Endurance at 11 Weeks|Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for primary outcome (n = 4 stabilization arm; n = 1 strengthening arm), and incomplete data for this outcome (n = 1 stabilization arm).|||seconds||Standard Error|Mean
1385474|NCT01401842|Primary|Isometric Lumbar Extension Muscular Strength at 11 Weeks|Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric lumbar extension muscular strength in Nm (mean ± SE) at follow-up|||Nm||Standard Error|Mean
1388737|NCT01369732|Secondary|Mortality|Participants will be followed for the mortality, an expected average of 1 month after surgery.|upto 1 month after surgery|||||||
1385475|NCT01401647|Secondary|Number of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.|MRS as a secondary outcome is not available on all patients that we have survival for.|||Participants|||Count of Participants
1385476|NCT01401647|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.|The primary objective is to determine if survival to hospital discharge is improved with early therapeutic administration of IV amiodarone (PM101) compared to placebo.The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of Lidocaine vs placebo; PM101 vs lidocaine.|||participants|||Number
1385477|NCT01401595|Secondary|Night Eating Symptoms|"The responses on the Night Eating Symptom Scale (NESS) will be examined over time.~Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0–56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms."|12 weeks||||units on a scale||Standard Error|Mean
1385478|NCT01401595|Secondary|Night Eating Symptoms|Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.|12 weeks||||units on a scale||Standard Error|Mean
1385479|NCT01401595|Primary|Change in Symptoms of NES|Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit.|12 weeks||||percentage of calories after dinner||Standard Error|Mean
1385480|NCT01401582|Secondary|Person With Dementia: Change in Medication|The DCM will conduct an IT-supported home medication review (Fiss et al., 2010) at the patients home with subsequent medication management by the local pharmacy regarding frequency of drug related problems, intake of PIM, clinically relevant drug-drug interaction, adherence, utilisation of adherence supporting activities (medication plan, drug dispenser, support by care service, reduction of the number of drugs taken|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2018-05-31|05/2018||||
1385481|NCT01401582|Secondary|Person With Dementia: Change in Utilization of Health Care Resources|"frequency of utilisation of~general physicians and physicians of other specialties~out-patient treatments~in-patient treatments~hospitalisations~institutionalisation~therapeutic appliances~standardised assessment with the Resource Utilization in Dementia (RUD, Wimo et al. 1998)."|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2018-05-31|05/2018||||
1385482|NCT01401582|Secondary|Person With Dementia and Caregiver: Change in Health Status|"Several instruments will be used to assess the health of the person with dementia:~the GP records the Fragebogen zum SF12- health survey (SF-12, Bullinger et al. 1998) the standardized assessment of elderly in primary care (STEP; Sandholzer et al. 2004) the Brief Symptom Inventory (BSI; Derogatis et al. 1983) the Patient´s health questionnaire (PHQ-D; Löwe et al. 2002, Spitzer et al. 1999)"|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2018-05-31|05/2018||||
1385483|NCT01401582|Secondary|Person With Dementia: Change in Social Support|The F-SozU (Fydrich et al. 2007) will be used to assess social support in several domains|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2018-05-31|05/2018||||
1385484|NCT01401582|Secondary|Person With Dementia: Change in Activities of Daily Living|"The functional status was assessed using the Bayer Activities of Daily Living Scale (B-ADL). It coonsits of 25 Items indicating everyday problems/ challenges. Their occurence is rated on a scale of 1 never, to 10 always. All ratings are added and divided by the number of items. This yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment."|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
1385485|NCT01401582|Primary|Reduction of Potential Inapropriate Medication (PIM)|Having to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as “a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition”. The PIM were identified using the Priscus list, which contains 83 drugs from 18 different drug classes.|one year after baseline assessment||||Participants|||Count of Participants
1385486|NCT01401582|Primary|Change in Medical Treatment With Antidementia Drugs|medication was systematically reviewed; A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs were considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01).|one year after baseline assessment||||participants|||Number
1385577|NCT01401101|Primary|PTSD Symptoms|same as baseline|6 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|||CAPS scores||95% Confidence Interval|Mean
1385487|NCT01401582|Primary|Change in Behavioral and Psychological Symptoms of Dementia|Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
1385488|NCT01401582|Primary|Change in Caregiver Burden|Caregiver burden was assessed using the „Berliner Inventar zur Angehörigenbelastung – Demenz“ (BIZA-D) (Zank et al., 2006). The BIZAD was developed to assess objective as well as subjective burden due to caring for a person wit dementia (PWD). It consists of 88 items covering 20 dimensions of caregiver burden. Objective burden is divided into six dimensions: 1) basic care tasks like support eating, hygiene etc (7 items), 2) extended care tasks like supporting grocery shopping, legal affairs etc. (3 items), 3) Motivation and Guidance (4 items), 4) emotional support (4 items), 5) supporting maintenance of social contacts (3 items) and 6) supervision (4 items). Each item has to be rated regarding the frequency of the support needed on a 5-Point scale (example: supervision; Does the patient need this kind of support: 1=always, 2= mostly, 3=partly, 4=hardly, 5= not at all). Then each item asks: Who is providing this support: all by someone else, mostly by someone else, evenly distributed|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
1385489|NCT01401582|Primary|Change in Quality of Life|The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52.|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
1385490|NCT01401517|Secondary|Assessment of Improvement of Quality of Life.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in measures of claudication symptoms at 10 weeks following the first administration of a dose. Quality of Life questionnaires (WIQ & RAND 36)will be completed prior to the first dose of the investigational product and again after 10 weeks of administration but before dose escalation.|10 weeks|||||||
1385491|NCT01401517|Secondary|Assessment of Changes in Walking Distance.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in functional measures of walking distance. The distance a subject can walk in 6 minutes will be measured prior to the first administration of the investigational product and 10 weeks after taking the investigational product but before the dose escalation.|10 weeks|||||||
1385492|NCT01401517|Secondary|Assessment of Changes in Brachial Artery Flow-Mediated Dilation (FMD)at 10 Weeks From Baseline|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in FMD by imaging before investigational product administration and 10 weeks after administration of investigational product but before dose escalation.|10 weeks|||||||
1385493|NCT01401517|Primary|Reporting of Adverse Events During 11 Week Treatment Period.|The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sodium nitrite compared with placebo over a 10 week treatment period. Subjects will be asked to report any adverse events during the trial period, and blood pressure, methemoglobin levels and other blood chemistries will be assessed during the trial period for changes from baseline.|11 weeks||||participants|||Number
1385494|NCT01401478|Secondary|Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination|"The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded.~Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks."|6 months||||Percentage of participants||95% Confidence Interval|Number
1385495|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
1385496|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
1385497|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
1385498|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
1385499|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.|6 months|The analysis for this outcome was based on the number of participants (55) who completed the study.|||Percentage of participants||95% Confidence Interval|Number
1385625|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||ml||Standard Deviation|Mean
1385501|NCT01401478|Primary|The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study|The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
1385502|NCT01401465|Secondary|The Percentage of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT|||percentage of participants|||Number
1385503|NCT01401465|Secondary|The Number of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT|||participants|||Number
1385504|NCT01401465|Secondary|The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT|||percentage of participants|||Number
1385505|NCT01401465|Secondary|The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT|||participants|||Number
1385506|NCT01401465|Secondary|Work/Disability Days: Reduced Activity Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|IIT|||Incidence Rate (#events/person-days)|||Number
1385507|NCT01401465|Secondary|Work/Disability Days: Missed Work|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population|||Incidence Rate (#events/person-days)|||Number
1385508|NCT01401465|Secondary|Work/Disability Days: Bed Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population|||Incidence Rate (#events/person-days)|||Number
1385509|NCT01401465|Secondary|Treatment Outcome Composite Score Assessed at the End of the Study|Reflects preference on items concerned with perceived drug effectiveness (longer relief; symptom relief; prefer if both were the same price; for feeling better about your appearance; for few problems with irritation to nose; faster relief; how it makes your nose feel). The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates an equal number of items preferred in the two groups. Larger values than 50 indicated greater than 50 percent of the subjects indicated preference for ciclesonide, while smaller values than 50 indicated greater than 50 percent preference for mometasone. Data is presented as the mean treatment outcome composite score. This analysis presents the comparison of ciclesonide versus mometasone in relation to preference for ciclesonide.|End of Study - Day 43|ITT Population|||Scores on a scale||Standard Deviation|Mean
1385510|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale|The mean of 1 question on how many days worked and 12 questions on level of satisfaction with work, ability to do work, problems completing work (physical and emotional); 1 questions on rating of leisure activities. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385511|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale|The mean of 11 questions on sleep disturbance, vitality and general health status. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385512|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale|The mean of 24 questions encompassing anxiety, depression, and loss of behavioral and emotional control (Psychological Distress), life satisfaction, positive well being and emotional ties (Psychological Well Being).Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385513|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale|The mean of 48 questions including allergic-rhinitis and allergic-rhinitis treatment specific and general symptoms measured for prevalence, frequency and distress severity. Scores range from 100 (lower satisfaction) to 600 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385514|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale|The mean of 7 questions concerning life interference due to nonallergic rhinitis specific symptoms (“other symptoms or health problems such as fatigue, pain and depression” with the same life activities: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) “feeling your best”. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385515|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale|The mean of 7 questions concerning interference with life activities due to the symptoms of allergic-rhinitis (nasal congestion, runny nose, itchy throat or sneezing) interfered with your ability to perform life activities. The life activities included: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) “feeling your best”. Scores range from 1 (lower satisfaction) to 6 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385578|NCT01401101|Primary|PTSD Symptoms|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|0 months (baseline)|all patients who completed the assessment|||CAPS scores||95% Confidence Interval|Mean
1385516|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)|The mean of 5 questions: Feeling past month 1) overall or in general, 2) physically, 3) emotionally, 4) personal life and 5) about job or work. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385517|NCT01401465|Secondary|The Change From Baseline in Overall Quality of Life Composite Score|Mean of all items in the Mental and Emotional Health and General Health Perceptions scales. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT|||scores on a scale||Standard Error|Least Squares Mean
1385518|NCT01401465|Secondary|The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief|The patient’s perceived level of relief along with the degree of satisfaction associated with that amount of relief was evaluated within this scale. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385519|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management|This subscale evaluates the patient’s assessment of issues relating to dosing (number of times and the time required to dose), ability to remember to use the spray, the ease/difficulty of the spray and several questions further pertaining to the convenience of the treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385520|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Burden|This subscale evaluates the patient’s assessment of the level of degree of burden that treatment for allergic rhinitis imposes on a number of areas, including adherence to the treatment regimen, exercise, performing daily activities, social activities, and enjoying life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385521|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle|This subscale focuses specifically on the patient’s assessment of the amount of bother and hassle of the treatment regimen, including coordinating activities, dosing, carrying supplies, rubbing nose or eyes, blowing nose repeatedly, or facial puffiness. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385522|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact|This subscale evaluates the patient’s assessment of the sensory attributes including medication running out of the nose, medication running down the throat, and impact on smell and taste. Issues regarding skipping the medication because of the way the nose feels and wanting to try other medications to find a better one are also included. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385523|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties|This subscale evaluates the patient’s degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385524|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation|This subscale evaluates the patient’s assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385525|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation|This subscale evaluates the patient’s assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1385526|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Interference|This subscale evaluates the patient’s assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
1388738|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria|Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.|upto 7 days after surgery|||||||
1385527|NCT01401465|Secondary|Change From Baseline in the Regimen Acceptance Composite Score|A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1385528|NCT01401465|Secondary|Change From Baseline in the Treatment Functional Impact Composite Score|A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||scores on scale||Standard Error|Least Squares Mean
1385529|NCT01401465|Secondary|Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.|The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.|Averages over each two week treatment period|Per Protocol (PP) Population|||units on a scale||Standard Error|Least Squares Mean
1385530|NCT01401465|Secondary|Treatment Process Composite Preference Score|The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less “Run out” of nose, Less “Run down” of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone.|End of Study - Day 43|ITT|||scores on a scale||Standard Deviation|Mean
1385531|NCT01401465|Primary|Change From Baseline in Regimen Attributes Composite Score|The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
1385532|NCT01401465|Primary|Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items|"For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less run out of nose, Longer relief, Less run down of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide."|End of Study - Day 43|Intent to Treat (ITT)- All randomized subjects who received at least one dose of study medication|||scores on a scale||Standard Deviation|Mean
1385533|NCT01401452|Secondary|Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 MCS was defined as an increase in MCS of at least 5 points from the baseline score."|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
1385541|NCT01401452|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
1402520|NCT01243320|Primary|Change In Alanine Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||u/L||95% Confidence Interval|Mean
1385534|NCT01401452|Secondary|Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 PCS was defined as an increase in PCS of at least 3 points from the baseline score."|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
1385535|NCT01401452|Secondary|Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months."|Baseline, Months 1, 3, 6, and 9|Participants with available data. Missing values were imputed if single answers were missing for one dimension.|||units on a scale||Standard Deviation|Mean
1385536|NCT01401452|Secondary|Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months."|Baseline, Months 1, 3, 6, and 9|Participants with available data. Missing values were imputed if single answers were missing for one dimension.|||units on a scale||Standard Deviation|Mean
1385537|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 100% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
1385538|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
1385539|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
1385540|NCT01401452|Secondary|Mean Dermatology Life Quality Index (DLQI) Scores|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||units on a scale||Standard Deviation|Mean
1385556|NCT01401166|Secondary|3-Year EFS Rate|EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.|Year 3|ITT Population|||proportion of participants||95% Confidence Interval|Number
1385542|NCT01401361|Secondary|Secondary Efficacy|"Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,~1c, III) during the 3 months post ablation are considered chronic failures."|3 months|134 subjects were treated with the investigational catheter and system with 10 subjects experiencing recurring AFL. Thus 124 subjects comprised the secondary efficacy cohort (freedom from AFL at 90 days).|||participants|||Number
1385543|NCT01401361|Primary|Primary Efficacy|Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes|134 subjects were treated with the investigational catheter and system with 1 subject failing to pass the bidirectional block inducibility test 30 minutes post ablation. Thus 133 subjects comprised the primary efficacy cohort.|||participants|||Number
1385544|NCT01401361|Primary|Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|150 subjects who met Inc/Excl criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 were treated. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.|||participants|||Number
1385545|NCT01401322|Primary|Time-to-Progression (TTP)||12 weeks||||Days||Full Range|Median
1385546|NCT01401283|Secondary|Hospital Stay|length of stay in the postoperative care unit, length of hospital stay|Participants will be followed for the duration of hospital stay, an expected average of 10 days||||days||Inter-Quartile Range|Median
1385547|NCT01401283|Primary|Postoperative Complications|Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)|Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days||||numbers of complications|||Number
1385548|NCT01401257|Secondary|To Assess the Plasma Concentrations of PXT3003|PXT3003 plasmatic concentrations after one administration (randomization) and after 1-,6-and 12-months of treatment.|Randomization, 1-, 6- and 12-month treatment|||||||
1385549|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on a Series of Biochemical Biomarkers|"Dosages of biochemical biomarkers in plasma.~Change from baseline after 3-month of treatment."|Randomization and 3-month treatment|||||||
1385550|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on Selected Neurophysiological Parameters|"Electrophysiological examination will be performed to assess sensory and motor responses of the median and ulnar nerves (non-dominant side) including: NCV, compound muscle action potential (CMAP) and SNAP.~Change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-month treatment|||||||
1385551|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on PMP22 mRNA Levels and Intra-epidermal Axon Density in Cutaneous Biopsy|"A cutaneous biopsy (consisting in 2 small punch biopsies) will be performed to assess PMP22 mRNA expression and intra-epidermal axon density.~Change from baseline after 12-month of treatment."|Randomization and 12-month treatment|||||||
1385552|NCT01401257|Secondary|To Obtain Preliminary Data on the Efficacy of PXT3003 on Clinical Scores and Functional Tests|"Efficacy scores and functional tests will be assessed CMTNS/CMTES:ONLS, VAS, fatigue, pain, six minute walk test (6MWT), nine-hole peg test, quantified muscular testing (QMT; hand grip and foot dorsiflexion), CGI.~For each test or score, change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-months treatment|||||||
1385553|NCT01401257|Primary|Safety and Tolerability of PXT3003|"The Primary Objective is to assess the clinical and laboratory safety and tolerability of three doses of PXT3003 administered orally for 12 months to CMT1A patients versus placebo.~Number of participants with adverse events in each arm."|Screening, randomization, 1-, 3-, 6-, 9-, 12-month treatment and 1-month follow-up||||Participants|||Count of Participants
1385554|NCT01401166|Secondary|Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies|Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.|Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)|Safety Population. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate immunogenicity within participants who received the SID formulation of Herceptin. The number of participants who provided ADA samples at each timepoint (n) is shown in the table.|||percentage of participants|||Number
1385555|NCT01401166|Secondary|"Percentage of Participants With Responses of Agree or Strongly Agree on the SC SID Satisfaction Questionnaire"|Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from “Strongly Disagree” to “Strongly Agree”. The percentage of participants with a positive response (either “Agree” or “Strongly Agree”) to each questionnaire statement was reported.|Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)|"Safety Population. The Number of Participants Analyzed reflects those who self-administered SC Herceptin using the SID and completed the SC SID questionnaire. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate satisfaction among those who self-administered the SID formulation of Herceptin."|||percentage of participants|||Number
1402521|NCT01243320|Primary|Change In Aspartate Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||u/L||95% Confidence Interval|Mean
1385557|NCT01401166|Secondary|Duration of EFS According to Kaplan-Meier Estimate|EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.|From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)|ITT Population|||months||95% Confidence Interval|Median
1385558|NCT01401166|Secondary|Percentage of Participants With an Event-Free Survival (EFS) Event|EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.|From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)|ITT Population|||percentage of participants|||Number
1385559|NCT01401166|Secondary|Percentage of HCPs by Time Required to Perform Each Method of Drug Administration|"The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (>) 20 minutes. Responses of Not Sure and Unknown were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported."|Week 24|HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.|||percentage of HCPs|HCPs||Number
1385560|NCT01401166|Secondary|Percentage of HCPs by Most Satisfied Method of Drug Administration|The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, “All things considered, with which method of administration were you most satisfied?” at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported.|Week 24|HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.|||percentage of HCPs|HCPs||Number
1385561|NCT01401166|Primary|Percentage of Participants by Preferred Method of Drug Administration|The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, “All things considered, which method of administration did you prefer?” at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.|Week 24|Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.|||percentage of participants|||Number
1385562|NCT01401153|Primary|Mean Time Incorrect Reactions|Mean time to react incorrectly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Seconds||Inter-Quartile Range|Median
1385563|NCT01401153|Primary|Mean Time Correct Reactions|Mean time to react correctly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Seconds||Inter-Quartile Range|Median
1385564|NCT01401153|Primary|Incorrect Reactions|Number of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Incorrect reactions||Inter-Quartile Range|Median
1385565|NCT01401153|Primary|Number Correct Reactions|Number of correct reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Correct reactions||Inter-Quartile Range|Median
1385566|NCT01401153|Primary|Percentage Incorrect Reactions|Percentage of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Incorrect reactions %||Inter-Quartile Range|Median
1385567|NCT01401153|Primary|Reactions|Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Total reactions||Inter-Quartile Range|Median
1385568|NCT01401153|Primary|Sequencing Errors|Sequences including all the blocks of a prescribed sequence, but in the wrong order|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Sequences with wrong order||Inter-Quartile Range|Median
1385569|NCT01401153|Primary|Correct Immediate Block Span|Number of sequences correctly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Sequences correctly reproduced||Inter-Quartile Range|Median
1385570|NCT01401153|Primary|Incorrect Immediate Block Span|Number of sequences incorrectly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Sequences incorrectly reproduced||Inter-Quartile Range|Median
1385571|NCT01401153|Primary|Immediate Block Span|Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Longest sequence correctly reproduced||Inter-Quartile Range|Median
1385572|NCT01401153|Primary|Tonic Alertness (Omission Errors)|Stimuli to which no reaction follows within 1.5s|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Omission errors||Inter-Quartile Range|Median
1385573|NCT01401153|Primary|Tonic Alertness (Commission Errors)|Reactions when no stimulus had been presented|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Commission errors||Inter-Quartile Range|Median
1385574|NCT01401153|Primary|Tonic Alertness (Deviation of Reaction Time)|Deviation of reaction time --> logarithmic standard deviation of the reaction times|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Unitless||Inter-Quartile Range|Median
1385575|NCT01401153|Primary|Tonic Alertness (Mean Reaction Time)|Mean reaction time to response to a simple visual stimulus without a preceding warning signal|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Milliseconds||Inter-Quartile Range|Median
1385579|NCT01401062|Primary|Abscopal Response Rate|Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).|up to 20 weeks||||Participants|||Count of Participants
1385580|NCT01401049|Secondary|To Compare Patient Satisfaction With Sedation Including the Recall of Pain.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours after the end of the procedure.|No data displayed because Outcome Measure has zero total participants analyzed.||||||
1385581|NCT01401049|Primary|Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours|Due to flooding from Hurricane Sandy at our site, all files and pertinent patient data were lost.||||||
1385582|NCT01401023|Primary|Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile|Stool levels of tigecycline|day 3 of treatment||||micrograms/gram||Standard Deviation|Mean
1385583|NCT01401023|Primary|Mean (SD) Stool Tigecycline Concentration Level|Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay|day 3 of tigecycline therapy||||micrograms/gram||Standard Deviation|Mean
1385584|NCT01401023|Primary|Mean (SD) Serum Tigecycline Concentration Level|Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.|day 3 of tigecycline therapy||||milligram/liter||Standard Deviation|Mean
1385585|NCT01401023|Primary|Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates||day 1 stool sample||||milligram/liter||Standard Deviation|Mean
1385586|NCT01401023|Primary|Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile|Serum levels of tigecycline|day 3 of treatment||||milligrams/liter||Standard Deviation|Mean
1385587|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic area under serum curve of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||milligrams * hour/liters||Standard Deviation|Mean
1385588|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic clearance of drug of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||Liters/hour||Standard Deviation|Mean
1385589|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic half life of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||hours||Standard Deviation|Mean
1385590|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic elimination rate constant of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||hour^-1||Standard Deviation|Mean
1385591|NCT01401010|Secondary|Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC))|"Following determination of pharmacokinetic (PK) parameters from patients with febrile neutropenia, Monte Carlo simulations were then conducted to determine time of serum concentrations above the MIC (40% of the time) against Gram-negative isolates.~These Gram-negative isolates had a range of minimum inhibitory concentrations (MIC) to Doripenem."|1, 4, 6, 8 hours after an infusion of doripenem to determine the PK parameters|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||probability of target attainment|||Number
1385592|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic volume of distribution of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||Liters||Standard Deviation|Mean
1385593|NCT01400958|Secondary|Occurrence of Improved Cognitive Performance|Determine if Nuvigil® improves cognitive function of patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained average (T=50) to slightly below average (T=40 or greater) cognitive function.|5 months|Available, evaluable participants with average T Score range cognitive function at baseline|||participants|||Number
1385594|NCT01400958|Primary|Occurrence of Improved Fatigue Experience After Treatment|Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine).|5 months|Available, evaluable participants with minimal fatigue at baseline|||participants|||Number
1385618|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||l/min/m^2||Standard Deviation|Mean
1385595|NCT01400932|Secondary|Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Itching and burning/stinging were evaluated by the participant as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (mild)=noticeable discomfort that caused continuous awareness; 3 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 4 (severe)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
1385596|NCT01400932|Secondary|Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Erythema (redness), dryness, and peeling were evaluated independently by the investigator as: 0 (absent)=no erythema, dryness, or peeling; 1 (slight)=faint red/pink coloration, barely perceptible dryness with no flakes or fissure, mild localized peeling; 2 (mild)=light red/pink coloration, perceptible dryness with no flakes/fissure, mild and diffuse peeling; 3 (moderate)=medium red coloration, easily noted dryness and flakes but no fissure, moderate and diffuse peeling; 4 (severe)=beet red coloration, dryness with flakes and fissure, prominent dense peeling. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
1385597|NCT01400932|Secondary|Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12|The proportion of participants who have a reduction in total lesions (inflammatory and non-inflammatory) of at least 50% from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1385598|NCT01400932|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1385599|NCT01400932|Secondary|Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Baseline and Week 12|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Number
1385600|NCT01400932|Secondary|Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12|The percent change from Baseline to Weeks 1, 2, 4, 8, and 12 in lesion counts (total [inflammatory and non-inflammatory], inflammatory [IL], and non-inflammatory [NIL]) was analyzed using an ANOVA model with terms for treatment and center. Percent change from Baseline was calculated as: (post-Baseline value minus Baseline value) * 100.|Baseline; Weeks 1, 2, 4 and 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percent change in lesion counts||Standard Error|Least Squares Mean
1385601|NCT01400932|Secondary|Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Lesion counts||Standard Error|Least Squares Mean
1385619|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||l/min||Standard Deviation|Mean
1385602|NCT01400932|Secondary|Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, and 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Lesion counts||Standard Error|Least Squares Mean
1385603|NCT01400932|Primary|Absolute Change in Total Lesion Counts From Baseline to Week 12|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all randomized participants who received at least one application of investigational product. Only those participants with data available at the specified time point were analyzed. Analysis was based on an analysis of covariance (ANCOVA) model with terms for Baseline value, treatment, and center.|||Lesion counts||Standard Error|Least Squares Mean
1385604|NCT01400919|Primary|Major Adverse Event Rate||9 months||||percentage of participants|||Number
1385605|NCT01400906|Secondary|Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period|Sputum induction was performed using hypertonic saline solution to collect an adequate sample of secretions from lungs. The collected sputum was analyzed for neutrophil and eosinophil counts. Sputum induction was performed after methacholine challenge and post-dose administration on Day 7. Zero values are imputed to 0.001 for this analysis. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.|||10^4 cells per gram of sputum||95% Confidence Interval|Geometric Mean
1385606|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in WM FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants were non-smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1385607|NCT01400906|Primary|LAR - Smokers: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1385608|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were non-smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1385620|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||l/min||Standard Deviation|Mean
1385609|NCT01400906|Secondary|Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period|The concentration of eNO was measured on Day 6 pre-dose and on Day 7 post-study medication administration. eNO was measured 3 times at each time point, and all 3 measurements were recorded. The mean of the 3 measurements was calculated and was used in the derivation of summary statistics.|Day 6 and Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.|||Parts per billion||Standard Deviation|Mean
1385610|NCT01400906|Secondary|Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% decrease in FEV1 from the post-saline value was achieved.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.|||milligrams per milliliter||95% Confidence Interval|Geometric Mean
1385611|NCT01400906|Secondary|Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline FEV1 was measured on Day 1 pre-dose administration. FEV1 was measured on Day 1 post-dose, on Day 6 (prior to allergen challenge), and on Day 7 pre dose administration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Baseline, Day 1, Day 6, and Day 7|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.|||Liters||95% Confidence Interval|Least Squares Mean
1385612|NCT01400906|Secondary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes [min], 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs). The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.|||Liters||95% Confidence Interval|Least Squares Mean
1385613|NCT01400906|Primary|Late Asthmatic Response (LAR) - Smokers: Absolute Change From Saline in Minimum Forced Expiratory Volume in One Second (FEV1) Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (all participants who received at least one dose of study medication) who had a post-dose FEV1 assessment in the same period. Only those participants who were smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1385614|NCT01400893|Secondary|Renal Replacement Therapy Dependency at Day 60.|RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.|Day 60 following treatment initiation|per protocol.|||Participants|||Count of Participants
1385615|NCT01400893|Primary|The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.|"All cause mortality through day 60 post-randomization.~The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time."|Day 60 following treatment initiation|Outcome data is reported for those subjects in which the calcium levels were maintained in the protocol's recommended range (≤0.4 mmol/L) for greater or equal to 90% of the therapy time.|||Participants|||Count of Participants
1385616|NCT01400880|Primary|Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC|Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.|Stage I and II Labor|Pregnant women between the ages of 18-50 with a single viable fetus in stages I and/or II of labor|||seconds||Standard Deviation|Mean
1385617|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||l/min/m^2||Standard Deviation|Mean
1385627|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 3 of 11 participants.|||cm||Standard Deviation|Mean
1385628|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 5 of 15 participants.|||cm||Standard Deviation|Mean
1385629|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 7 of 11 participants.|||cm||Standard Deviation|Mean
1385630|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants.|||cm||Standard Deviation|Mean
1385631|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 6 of 11 participants.|||g||Standard Deviation|Mean
1385632|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants|||g||Standard Deviation|Mean
1385633|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.|||mm Hg||Standard Deviation|Mean
1385634|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.|||mm Hg||Standard Deviation|Mean
1385635|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.|||mm Hg||Standard Deviation|Mean
1385636|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.|||mm Hg||Standard Deviation|Mean
1385637|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years postprocedure (extended follow-up)||||participants|||Number
1385638|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months postprocedure|NYHA evaluation not done on 1 of 15 participants|||participants|||Number
1385639|NCT01400841|Secondary|Event-free Survival|Event-free survival is defined as survival free from device-related death|6 months postprocedure||||percentage of participants||95% Confidence Interval|Number
1385640|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 2 years postprocedure:~Device-related mortality~Complete heart block~Structural device failure~Endocarditis~Periprosthetic leak or dehiscence~Thromboembolism~Bleeding Event~Native Valve Deterioration~Valve Thrombosis~Hemolysis~Reoperation and explant at 2 years"|2 years postprocedure||||percentage of implant procedures||95% Confidence Interval|Number
1385641|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 1 month postprocedure:~Device-related mortality~Complete heart block~Structural device failure~Endocarditis~Periprosthetic leak or dehiscence~Thromboembolism~Bleeding Event~Native Valve Deterioration~Valve Thrombosis~Hemolysis~Reoperation and explant at 1 month"|1 month postprocedure||||percentage of implant procedures||95% Confidence Interval|Number
1385642|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:~Aortic annular dissection, rupture, or leaflet damage~Paravalvular leak > +2 or requiring intervention~Mitral valve impingement due to implant~implant dehiscence/migration into aorta~implant dehiscence/migration into left ventricle~Hemodynamics requiring intervention~Other adverse event resulting in reoperation, explantation, or permanent disability."|2 years postprocedure (extended follow-up)||||percentage of implant procedures||95% Confidence Interval|Number
1385643|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:~Aortic annular dissection, rupture, or leaflet damage~Paravalvular leak > +2 or requiring intervention~Mitral valve impingement due to implant~implant dehiscence/migration into aorta~implant dehiscence/migration into left ventricle~Hemodynamics requiring intervention~Other adverse event resulting in reoperation, explantation, or permanent disability."|discharge or 14 days postprocedure, whichever comes first||||percentage of implant procedures||95% Confidence Interval|Number
1385644|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years postprocedure (extended follow-up)||||participants|||Number
1385645|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months postprocedure||||participants|||Number
1385646|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|2 years postprocedure (extended follow-up)|Extended follow-up participants|||percentage of participants||95% Confidence Interval|Number
1385647|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|1 month postprocedure||||percentage of participants||95% Confidence Interval|Number
1385648|NCT01400698|Post-Hoc|Duration of Participation in the Study||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluated for this measure.|||years||Standard Deviation|Mean
1385649|NCT01400698|Post-Hoc|Duration of Treatment||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were treated and hence, were evaluated for this measure.|||years||Standard Deviation|Mean
1385650|NCT01400698|Secondary|Parental Adjusted Height Standard Deviation Score (PAHSDS)|PAHSDS is the distance between the participant’s current and target heights, expressed in units of SD of the height distribution of the reference population. Target height is a measure of the height which the participant could hypothetically reach based only on his parents’ heights. Target height standard deviation score (THSDS) was calculated as target height minus mean adult height of the reference population divided by SD of the mean adult height of the reference population.|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.|||standard deviation score||Standard Deviation|Mean
1385651|NCT01400698|Primary|Height Standard Deviation Score (HSDS)|HSDS was calculated as height minus reference mean height divided by SD of the reference mean height, both given by the reference growth table (Sempe) for the corresponding chronological age at the height measurement. Greater HSDS indicate greater height. (Sempe M et al., 1979)|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.|||standard deviation score||Standard Deviation|Mean
1385652|NCT01400698|Primary|Final Height|Final height was defined as the height reached 1 year after height velocity (HV) was less than 2 centimeter/year (cm/year). Height velocity was the change in height since the previous year’s measurement. Height was measured with a wall-mounted stadiometer (or in supine position if the participant’s age was less than 3 years) and the measurement was repeated thrice by the same observer. The mean of the values obtained in the repeated measurements was taken for the analysis.|One year after final height was attained up to 10.6 years|Intention-to-treat (ITT) population included all participants enrolled in this study. Safety population was identical in this study.|||cm||Standard Deviation|Mean
1385653|NCT01400516|Secondary|Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.|||score on a scale||Standard Deviation|Mean
1385654|NCT01400516|Secondary|Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan|BMD was measured at the lumbosacral spine antero-posterior and at the femoral neck using a densitometer. A positive change from Baseline (increased bone density) indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.|||grams/centimeters squared (g/cm^2)||Standard Deviation|Mean
1385655|NCT01400516|Primary|Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan|Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.|||cubic millimeter (mm^3)||Inter-Quartile Range|Median
1385656|NCT01400503|Secondary|Number of Participants Positive for Antibodies to Siltuximab|Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||Participants|||Count of Participants
1385657|NCT01400503|Secondary|Overall Survival|Overall survival was defined as the time between the first study siltuximab administration and death due to any cause. Kaplan-Meier method was used to estimate the overall survival.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||years||95% Confidence Interval|Median
1385658|NCT01400503|Secondary|Duration of Disease Control|Duration of disease control (DODC) was defined as the time from the first siltuximab administration in this study to disease progression as assessed by the investigator. Disease control was defined as stable or better response assessed by the investigators. Kaplan-Meier method was used to estimate the duration of disease control.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||years||95% Confidence Interval|Median
1385659|NCT01400503|Secondary|Percentage of Siltuximab-naive Participants Who Experienced Disease Control|Percentage of participants experiencing disease control was defined as the percentage of siltuximab-naïve participants who had stable or better response during the long-term safety extension based on investigator’s judgment. Disease control was defined as stable or better response assessed by the investigators.|Up to 6 years|Population included subset of safety analysis set who were previously Siltuximab-naive i.e., received placebo in study CNTO328MCD2001 and never received siltuximab prior to enrollment in this study.|||percentage of participants|||Number
1385660|NCT01400503|Secondary|Percentage of Previously Responding Participants Who Maintained Disease Control|Percentage of participants maintaining disease control (defined as stable or better response) was defined as the percentage of previously responding participants who had not progressed during the long-term safety extension based on investigator assessment. A worsening in any of the measures will be considered as a progression of the disease.|Up to 6 years|Population included subset of safety analysis set who previously responded to siltuximab treatment ie, did not report disease progression while receiving siltuximab in study C0328T03 or CNTO328MCD2001.|||percentage of participants|||Number
1385661|NCT01400503|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||Participants|||Count of Participants
1385662|NCT01400451|Primary|Number of Participants With Hepatic Dose Limiting Toxicities (DLT) in Participants Treated With Concurrent Ipilimumab and Vemurafenib|DLT defined as a >= Grade 3 drug-related AE during induction with ipilimumab in combination with vemurafenib excluding: Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor); Grade 3 cutaneous squamous cell carcinoma; Grade 3 photosensitivity that resolved to a Grade 1 or baseline within 15 days; Grade 3 immune-mediated events of the skin (rash, pruritis) or endocrine systems (hypothyroidism, hyperthyroidism, hypopituitarism, adrenal insufficiency, hypogonadism and cushingoid) that resolved to a Grade 1 or baseline within 28 days; a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Hepatic=elevated aspartate aminotransferase and alanine aminotransferase. Maximum tolerable dose (MTD) was defined as the maximum dose of combination treatment that could be given to 6 subjects such that no more than 2 subjects experience DLT. Day 1=first day of concurrent therapy with ipilimumab and vemurafenib.|Day 1 to last dose of drug + 90 (approximately 2 years)|All participants who received at least one dose of concurrent study drugs.|||participants|||Number
1385663|NCT01400451|Primary|During the Combination Treatment Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Concurrent Ipilimumab and Vemurafenib|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. AEs: onset on or after ipilimumab start and within 90 days of last dose. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Day 1=first dose of ipilimumab.|Combination drugs: Day 1 to last dose of drug + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.|||participants|||Number
1385664|NCT01400451|Primary|During the Lead In Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Vemurafenib Alone|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Lead In Period: between the first vemurafenib dose and the day prior to the first ipilimumab dose.|From first vemurafenib dose to day prior to first ipilimumab dose (28 days); Patients who never progressed from Lead-in to combination treatment (720 mg Alone): first dose to last dose + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.|||participants|||Number
1385665|NCT01400425|Other Pre-specified|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis After Obtaining a Florbetapir F 18 PET Scan.|The impact of a florbetapir F 18 PET scan on a physician's clinical diagnosis of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a florbetapir scan that led to a change in hypothetical clinical diagnosis is presented below.|6 weeks|Subjects who have received a florbetapir scan (either positive or negative).|||Percentage of subjects||95% Confidence Interval|Number
1385666|NCT01400425|Secondary|Change in Physician Management Plans|Determine the percentage of subjects that had at least one hypothetical change between pre and post scan physician management plans. Change in management is defined as the number of subjects prescribed different item-wise plans at the two assessments divided by the total number of subjects in the population with both a pre and post florbetapir F 18 PET scan physician management plan.|6 weeks|All subjects with progressive cognitive decline who have received a florbetapir scan.|||Percentage of subjects||95% Confidence Interval|Number
1385667|NCT01400425|Secondary|Change in Confidence of the Clinical Diagnosis|Change in confidence of the clinical diagnosis prior to obtaining a florbetapir F 18 PET scan to the confidence after obtaining a florbetapir F 18 PET scan among subjects in whom the clinical diagnosis remains unchanged. Confidence levels were self-determined by physicians based on their diagnostic certainty and ranged from 0-100%. The mean (SD) change in confidence reflects the average change in diagnostic confidence along the 0-100% scale for the 62 subjects analyzed.|6 weeks|The hypothetical clinical diagnosis remained unchanged in 62 of 229 subjects who received a florbetapir scan.|||Percent Change in Confidence||Standard Deviation|Mean
1385668|NCT01400425|Other Pre-specified|Item Wise Changes in Physician Management Plan|This outcome analyzed the percentage of subjects who had a hypothetical change in one of the medication or diagnostic categories listed below after receiving a florbetapir scan.|6 weeks|The number of subjects analyzed for each reporting group is determined by scan status. There were 229 total subjects with progressive cognitive decline of whom 113 received a positive florbetapir scan and 116 received a negative florbetapir scan.|||Percentage of subjects|||Number
1385682|NCT01400412|Secondary|Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385669|NCT01400425|Secondary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Positive Florbetapir F 18 PET Scan|The impact of a positive florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a positive florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A positive florbetapir PET scan is indicative of moderate to frequent β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|113 out of 229 subjects with progressive cognitive decline received a positive florbetapir scan.|||Percentage of subjects||95% Confidence Interval|Number
1385670|NCT01400425|Primary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Negative Florbetapir F 18 PET Scan.|The impact of a negative florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a negative florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A negative florbetapir PET scan is indicative of none to sparse β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|116 of 229 subjects with progressive cognitive decline received a negative florbetapir scan.|||Percentage of subjects||95% Confidence Interval|Number
1385671|NCT01400412|Secondary|Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events|"Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.~See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)"|From study treatment initiation to week 48|All participants who initiated study treatment|||participants|||Number
1385672|NCT01400412|Secondary|Number of Participants Who Died During the Study||From study treatment initiation to week 48|All participants who started study treatment|||participants|||Number
1385673|NCT01400412|Secondary|Number of Participants Who Experienced Bone Fractures|Number of participants who experienced bone fractures during the study|From study treatment initiation to week 48|All participants who started study treatment|||participants|||Number
1385674|NCT01400412|Secondary|Cumulative Probability of Virologic Failure by Week 48|"Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.~Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group."|From study treatment initiation to week 48|All participants who started study treatment|||cumulative probability per 100 persons||95% Confidence Interval|Number
1385675|NCT01400412|Secondary|Change in Levels of D-dimer From Baseline||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||ng/ml||Inter-Quartile Range|Median
1385676|NCT01400412|Secondary|Change in Levels of sCD14 From Baseline|Change in levels of soluble CD14 from baseline|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||ng/ml||Inter-Quartile Range|Median
1385677|NCT01400412|Secondary|Change in Levels of sCD163 From Baseline to Week 48|Change in levels of soluble CD163 from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||ng/ml||Inter-Quartile Range|Median
1385678|NCT01400412|Secondary|Change in Level of IP-10 From Baseline to Week 48|Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||pg/ml||Inter-Quartile Range|Median
1385679|NCT01400412|Secondary|Change in Levels of IL-6 From Baseline to Week 48|Change in levels of Interleukin 6 (IL-6) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||pg/ml||Inter-Quartile Range|Median
1385680|NCT01400412|Secondary|Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385681|NCT01400412|Secondary|Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385723|NCT01399788|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1385683|NCT01400412|Secondary|Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385684|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385685|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385686|NCT01400412|Secondary|CD8+ T-cell Change From Baseline to Week 48||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||cell/mm^3||Inter-Quartile Range|Median
1385687|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 48|Change in CD4 count from baseline (week 0) to week 48|Week 0, week 48|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.|||cells/mm^3||Inter-Quartile Range|Median
1385688|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 24|Change in CD4 count from baseline (week 0) to week 24|Week 0, week 24|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.|||cells/mm^3||Inter-Quartile Range|Median
1385689|NCT01400412|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD)|The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385690|NCT01400412|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)|The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|The primary analysis was as-treated which included only participants with total hip BMD measurements available at both week 0 and week 48 who remained on their randomized MVC or TDF component by the time week 48 measurement was taken without an interruption of treatment of more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
1385691|NCT01400243|Primary|POMS Vigor/Positive Affect (PA)|"Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from 0 (no vigor) to 32 (maximally high vigor score)."|16 days (baseline through day 15 of treatment)||||units on a scale||Standard Error|Mean
1385692|NCT01400243|Primary|Marijuana Withdrawal Questionnaire (MWC) Total Score|"The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from 0 = no withdrawal symptoms to 47 = maximally high levels of withdrawal."|16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)||||units on a scale||Standard Error|Mean
1385693|NCT01400243|Secondary|Diastolic Blood Pressure (DBP)|Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.|From baseline to Day 15 of abstinence||||mm Hg||Standard Error|Mean
1385694|NCT01400243|Secondary|Heart Rate|Heart rate measured during laboratory assessment sessions.|Baseline through Day 15 of abstinence||||beats per minute||Standard Error|Mean
1385695|NCT01400243|Secondary|Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.|Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.|across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence||||ng/ml urine creatinine-corrected THC||Standard Error|Mean
1385696|NCT01400243|Secondary|Tobacco and Nicotine Intake|Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.|Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.||||Cigarettes per 30 days||Standard Error|Mean
1385697|NCT01400243|Secondary|Systolic Blood Pressure (SBP)|Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.|From baseline to Day 15 of abstinence||||mmHg||Standard Error|Mean
1385698|NCT01400243|Secondary|Patch Guess and Attributions Questionnaire|The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.|Day 15 of abstinence||||Percentage chance on nicotine patch||Standard Error|Mean
1385699|NCT01400243|Primary|Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)|"POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of 0 = best possibly level and a maximum value of 154 = worst possible level."|16 days (prequit baseline and 15 days of abstinence)||||units on a scale||Standard Error|Mean
1385767|NCT01399099|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months|||||||
1385700|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part II|The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided.|At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension|||||||
1385701|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part I|The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. TSQ - Part I was not administered in the extension period.|At Week 52 or upon early discontinuation at or before Week 4 in maintenance|||||||
1385702|NCT01400139|Secondary|Patient Global Impression of Change (PGIC)|The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. The proportion of subjects with a response of “much improved” (category 2) and “very much improved” (category 1), is provided along with 95% confidence intervals for the proportion.|At Week 52 in maintenance and at Week 24 in extension|||||||
1385703|NCT01400139|Secondary|Medical Outcomes Study 36-item Short Form (SF-36)|The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject’s perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. For SF-36, a higher score indicates a better perception of health.|Up to 52 weeks in maintenance and up to 24 weeks in extension|||||||
1385704|NCT01400139|Secondary|Brief Pain Inventory Short Form (BPI-SF) - Pain Interference|The BPI-SF questionnaire was used to assess the severity of pain and the interference of pain on daily functions. It consists of 9 sections that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Four of the items (questions 3 through 6) assess the severity of pain and 7 items (questions 9A through 9G) assess the interference of pain. The pain severity subscale was determined by calculating the arithmetic mean of the responses to items 3, 4, 5 and 6. For BPI, a lower score indicates a lower pain.|Up to 52 weeks in maintenance and up to 24 weeks in extension|||||||
1385705|NCT01400139|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep: sleep problems index II and 6 subscale scores – sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For the derived scores in the MOS Sleep-R, a higher score indicates a better sleep pattern.|Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period|||||||
1385706|NCT01400139|Secondary|"Pain Right Now Score"|"“Pain right now” scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The pain right now scores were only collected during the Core Study. “Pain right now” scores were not assessed during the Extension Period."|Week 12|||||||
1385707|NCT01400139|Primary|"Daily Average Pain Over the Last 24 Hours"|"Average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks)|The Core Study population analyzed (N=727) was the group of subjects who received at least 1 dose of study drug during the maintenance period. The Extension Period population analyzed (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.|||units on a scale||Standard Deviation|Mean
1385708|NCT01400139|Primary|The Number of Participants With Adverse Events as a Measure of Safety|Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.|Up to 84 weeks|The Core Study safety population (N=922) was defined as the group of subjects who received at least 1 dose of study drug during the study. The Extension Period safety population (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.|||participants|||Number
1385709|NCT01400113|Secondary|Clinical Global Impression Scale|Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.|2 hours|||||||
1385710|NCT01400113|Primary|Positive and Negative Syndrome Scale - Excited Component|The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies.|Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.||||PANSS SCORE||95% Confidence Interval|Mean
1385768|NCT01399099|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks|||||||
1385769|NCT01399099|Secondary|Ease of Use||Up to 12 months|||||||
1385770|NCT01399099|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months|||||||
1385711|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET The Emotional Stroop uses smoking-related words and neutral words to measure attentional bias toward smoking related cues. Attentional bias is a central feature of many cognitive theories of addiction and can be measured with an emotional analog of the Stroop task. In this task, participants name the colors in which words are printed, and the words vary in their relevance to smoking. Extensive research has shown that patients are often slower to name the color of a word associated with concerns relevant to their clinical condition due to distraction by the meaning of the word(Williams, Mathews et al. 1996). The Stroop interference Score is obtained by subtracting Reaction Time (RT) to smoking minus the Reaction Time to neutral|Baseline and week 6||||Stroop interference Score||Standard Deviation|Mean
1385712|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Craving|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less craving at the Post-Extinction Assessment than those who receive placebo + CET The scale used to measure craving was a Visual Analogue Scale 0 (no desire at all) - 7 (unable to resist)|Up to 6 weeks||||change in units on a scale||Standard Deviation|Mean
1385713|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (electromyogram) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||change in micro volts||Standard Deviation|Mean
1385714|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||change in beats per minute||Standard Deviation|Mean
1385715|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (skin conductance) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.|Up to 6 weeks||||change in microSiemens||Standard Deviation|Mean
1385716|NCT01399866|Primary|Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.|Participants assigned to receive D-cycloserine + CET will achieve better maintenance of tobacco abstinence, as assessed with self-report and saliva cotinine measurements, than those who receive placebo + CET at week 6 follow up visits|Up to 6 weeks||||percentage of participants|||Number
1385717|NCT01399788|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||hr||Full Range|Median
1385718|NCT01399788|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.|||hr||Standard Deviation|Mean
1385719|NCT01399788|Secondary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞][dn]) for Pyrazinamide|AUC [0-∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-∞) divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
1385720|NCT01399788|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
1385721|NCT01399788|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) for Pyrazinamide|It is obtained from Cmax divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||(ng/mL)/mg||Standard Deviation|Geometric Mean
1385722|NCT01399788|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) for Pyrazinamide|AUClast[dn] = Dose normalized area under the plasma concentration-time curve (AUC[dn]) from time zero (pre-dose) to the time of last measured concentration. It is obtained from AUClast divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
1402522|NCT01243320|Primary|Change In Alkaline Phosphatase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||u/L||95% Confidence Interval|Mean
1385724|NCT01399788|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1385725|NCT01399723|Secondary|Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview|Definition of death as described in third secondary outcome measure.|Day 14||||participants|||Number
1385726|NCT01399723|Secondary|Death at or Before Five Days Following Enrollment|Death defined as: in-hospital death occurring at any time after randomisation (recruitment for HIV-exposed participants) or verbal report of death of the enrolled patient from parent/guardian communicated either directly or via telephone conversation.|Day 0 to Day 5|||||||
1385727|NCT01399723|Secondary|Readmission With Diagnosis of Severe or Very Severe Pneumonia Within 14 Days of Enrollment||Day 0 to Day 14|||||||
1385728|NCT01399723|Secondary|Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First)|Treatment failure as defined in the primary outcome measure.|Patients will be followed up from the day of hospitalisation (day 0) until the day of medical discharge (average duration of 3 days) or until day 5 of hospitalisation (whichever occurs first).|Intention to treat analysis|||participants|||Number
1385729|NCT01399723|Primary|Treatment Failure at 48 Hours (Two Full Days After Enrollment)|Development of any signs of very severe pneumonia at any time Hypoxemia defined as SpO2 <85% or <80% for altitude < or ≥1500m respectively measured after minimum of 3 minutes on ambient air Persistent vomiting (occurring within 30 minutes of administration of amoxicillin with failure to retain drug after 3 successive attempts at administration) at any time Clinical diagnosis of new bacterial co-morbid condition requiring revision of antibiotic treatment at any time Lower chest wall indrawing Temperature ≥38◦C Respiratory rate ≥5bpm of admission rate if above age-adjusted normal upper limit|48 hours|Intention to treat analysis|||participants|||Number
1385730|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
1385731|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
1385732|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life.|Week 16 and Week 28|ITT Population; only participants with non missing data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1385733|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
1385734|NCT01399697|Secondary|Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
1385735|NCT01399697|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28|SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI <3.3 = clinical remission.|28 weeks|ITT Population; only participants with SDAI scores at Week 28 were included in the analysis.|||percentage of participants|||Number
1385736|NCT01399697|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28|CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters [cm]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI <2.8 = clinical remission.|Week 28|ITT Population; only participants with CDAI scores at Weeks 28 were included in the analysis.|||percentage of participants|||Number
1385794|NCT01398943|Primary|Flow-Mediated Dilation (FMD)|Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function at baseline and several hours after each experimental intervention.|Post FMD was taken approximately 110 min after baseline|Participants included patients diagnosed with COPD and healthy age-matched controls.|||percentage of change in FMD||Standard Deviation|Mean
1385737|NCT01399697|Secondary|Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 28|ITT Population; only participants with Week 28 DAS28 values were included in the analysis.|||percentage of participants|||Number
1385738|NCT01399697|Primary|Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline, Week 16, and Week 28|Intent-to-treat (ITT) population: all randomized participants who received at least one dose of study medication and who had at least one efficacy measurement performed.|||units on a scale||Standard Deviation|Mean
1385739|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS|||participants|||Number
1385740|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS|||participants|||Number
1385741|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.|48 weeks|FAS|||participants|||Number
1385742|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.|48 weeks|FAS|||participants|||Number
1385743|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS|||participants|||Number
1385744|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS|||participants|||Number
1385745|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no|The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.|48 weeks|FAS|||participants|||Number
1385746|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes|The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.|48 weeks|FAS|||participants|||Number
1385747|NCT01399619|Secondary|Early Treatment Success (ETS)|Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8|Week 4, week 8 and week 60|FAS|||participants|||Number
1385748|NCT01399619|Secondary|Virological Response 24 Weeks Post Treatment (SVR24)|Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.|72 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
1385749|NCT01399619|Primary|Sustained Virological Response (SVR12)|Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.|60 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
1385750|NCT01399593|Primary|Treatment Failure Rate|The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.|9 weeks post-transplantation|Full analysis set, defined as patients who were randomized, received a living donor kidney transplant, and were treated (either with eculizumab or SOC), based on randomized treatment groups.|||Participants|||Count of Participants
1385751|NCT01399268|Secondary|Ability to Ambulate||48 hours||||Participants|||Count of Participants
1385752|NCT01399268|Secondary|Mortality||Length of hospital stay, an expected average of 5 days||||Participants|||Count of Participants
1385753|NCT01399268|Secondary|In Hospital Infection Rate||Length of hospital stay, an expected average of 5 days||||Participants|||Count of Participants
1385754|NCT01399268|Secondary|Length of Hospital Stay||Length of hospital stay, an expected average of 5 days||||days||Standard Deviation|Mean
1385755|NCT01399268|Secondary|Blood Glucose||24 hours postoperative||||mg/dL||Standard Deviation|Mean
1385756|NCT01399268|Secondary|Desmosine Level||24 hours postoperative|Data were not collected||||||
1385757|NCT01399268|Primary|Decrease in IL6 Level||24 hours postoperative||||pg/ml||99% Confidence Interval|Mean
1385758|NCT01399229|Primary|Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing|Time Stamps of the Peaks of Corresponding Contractions|9 - 41 Minutes||||Seconds||Standard Deviation|Mean
1385759|NCT01399190|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to approximately 30 months|Includes enrolled participants eligible for inclusion in the final analysis.|||percentage of participants|||Number
1385760|NCT01399190|Secondary|Response Rate (Tumor Assessments According to RECIST)|Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR|Up to approximately 30 months|Includes enrolled participants who were evaluable for the primary endpoint analysis.|||percentage of participants|||Number
1385761|NCT01399190|Primary|Progression-free Survival|Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.|From randomization to progression or death during the study (up to approximately 30 months)|Includes enrolled participants who were evaluable for the primary endpoint analysis.|||months||95% Confidence Interval|Median
1385762|NCT01399125|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Score|The Mini-Mental State Examination (MMSE) was used to establish patient’s eligibility for the study and it was also used as an efficacy parameter in the Double-blind Treatment Period. The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating betterfunction. The total MMSE score at screening was between 10 and 20, inclusive, in order forthe patient to be eligible to participate in the trial.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||scores on a scale||Standard Deviation|Mean
1385763|NCT01399125|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|NPI including Caregiver Distress Scale (NPI-D) assesses a wide range of behavior problems encountered in dementia patients to provide a means of distinguishing frequency and severity of changes in behavioral problems & facilitates rapid behavioral assessment using screening questions.10 behavioral problems & 2 neurovegetative domains were evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency & severity ratings of ea. domain as well as a composite domain score(frequency x severity). Frequency: 1(occasionally) - 4(very frequently)&severity:1(mild) - 3(marked).The sum of the composite scores of the 12 domains yields the NPI total score. The NPI-D: 0(not severe & not at all distressing) - 5 (very severe or extremely distressing) for each of the 12 domains. NPI-12 total score: from 0-144, the NPI-10 total score: from 0-120, & NPI-D score: from 0-60, all with higher scores indicating more severe behavioral disturbance.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||scores on a scale||Standard Deviation|Mean
1385764|NCT01399125|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score|"Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) is a caregiver-based Activities of Daily Living (ADL) scale composed of 23 items developed for use in dementia clinical studies. It was designed to assess the patient’s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item were obtained from the caregiver through an interview. For each basic ADL, there was a forced choice of best response or a yes or no question with additional sub questions. Higher numbered scores and answers of yes reflected a more self-sufficient individual. Therefore, the higher total score, the higher functioning the patient was. The total score was the sum of all items and sub questions. The range for the total ADCS-ADL score was 0 to 78."|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||scores on a scale||Standard Deviation|Mean
1385765|NCT01399125|Secondary|Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)|Alzheimer’s disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale provides a single global rating of change from baseline. It was recommended that the baseline interview be conducted by two raters, one designated as the primary rater, the other as a backup. Both raters were independent trained clinicians, experienced in the assessment of patients with dementia. Neither rater was involved in any other way with the patients’ treatment or evaluation throughout the study. At baseline, both raters had access to all of the patient’s available records and evaluations. Subsequently, for all ratings of change from baseline, the rater relied solely on information obtained during the baseline interview of the patient and caregiver, including written notes and, if available, the baseline interview audio- or videotape. The rater had no access to any other safety or efficacy data, including all previous post-baseline ADCS-CGIC ratings by either rater.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||participants|||Number
1385766|NCT01399125|Primary|Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)|The Alzheimer’s Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||Scores on a scale||Standard Deviation|Mean
1385771|NCT01399099|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.~[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|12 months|Per protocol, all eligible patients who did not exit the study prematurely.|||Units on a scale||Standard Error|Mean
1385772|NCT01399047|Secondary|Feasibility of Clinical Trials in Rare Disorder|To pilot the feasibility of conducting controlled clinical trials of this rare neurological disorder base on collaboration between a national center of excellence in the disease (URBC), and children's local care-providers (pediatricians and/or local neurologists.||||||||
1385773|NCT01399047|Secondary|Preliminary Evidence of Efficacy|To gather preliminary evidence of the short-term (8 week) impact of mycophenolate mofetil on clinically relevant features of Juvenile Neuronal Ceroid Lipofuscinosis as measured by the Unified Batten Disease Rating Scale, including motor features, seizures, behavior, cognitive and functional measures.|8 week|||||||
1385774|NCT01399047|Primary|Tolerability|The primary outcome measure is tolerability, defined as the completion of 8 weeks on the assigned dosage of study drug.|8 weeks||||Participants|||Count of Participants
1385775|NCT01399008|Primary|Serum Uric Acid|Percent change from baseline in serum uric acid in Per Protocol population|Percent change from baseline in serum uric acid at Week 4|Per Protocol population (all randomized patients who received at least 1 dose of blinded study drug, had at least 1 post-treatment evaluation, had not violated any major entry criterion likely to confound an efficacy analysis and had not deviated significantly from the protocol between enrollment and study completion).|||percent change||Standard Deviation|Mean
1385776|NCT01398982|Secondary|Time to Ambulation|Time to ambulation (# of days)|In-patient hospital stay, average 4-5 days|||||||
1385777|NCT01398982|Secondary|Health Related Quality of Life|Short-form health-related quality of life 36 Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
1385778|NCT01398982|Secondary|Anxiety and Depression|Hospital Anxiety and Depression Scale Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
1385779|NCT01398982|Secondary|Pain Frequency and Intensity|Short-form McGill Pain Questionnaire Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
1385780|NCT01398982|Secondary|Sedation Level|Sedation score in-patient|In Hospital postoperative measures, average 4-5 days|||||||
1385781|NCT01398982|Secondary|Postoperative Nausea and Vomiting|Postoperative nausea and vomiting (score of 0-3)|In Hospital postoperative measures, average 4-5 days|||||||
1385782|NCT01398982|Secondary|Duration of Hospital Stay|Duration of hospital stay (# of days)|In-patient hospital stay, average of 4-5 days|||||||
1385783|NCT01398982|Secondary|Quality of Recovery|Quality of Recovery (QOR) score (0-18)|In-patient hospital stay, first post operative 48 hours|||||||
1385784|NCT01398982|Secondary|Anti-nausea Consumption|Total in-hospital cumulative anti-nausea consumption|In-patient hospital stay, average 4-5 days|||||||
1385785|NCT01398982|Secondary|First Bowel Movement|Time to first bowel movement (# of days)|In-patient hospital stay, average 4-5 days|||||||
1385786|NCT01398982|Secondary|Pain Disability|Pain Disability Index Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
1385787|NCT01398982|Secondary|Daily Pain Intensity Scores at Rest and With Movement|Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)|In Hospital postoperative measures, average 4-5 days|||||||
1385788|NCT01398982|Secondary|Total In-hospital Cumulative Opioid Consumption|Total in-hospital cumulative opioid consumption levels|In-patient hospital stay average of 4 - 5 days|||||||
1385789|NCT01398982|Primary|Mean Total Opioid Consumption|The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.|first postoperative 48 hours||||mg||Standard Deviation|Mean
1385790|NCT01398956|Secondary|The Incidence of Adverse Drug Reactions During the Entire Study Period|Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.|Through study completion, an average of 3 years|The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.|||Adverse Drug Reactions|||Number
1385791|NCT01398956|Secondary|The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period."|During the Treatment Period (up to 4.8 years)|The Full Analysis Set (FAS) consisted of all subjects with evaluable baseline and post-baseline values of generalized tonic-clonic (GTC) seizure frequency as the efficacy analysis, excluding those patients who seriously violated Good Clinical Practice (GCP).|||percent change||95% Confidence Interval|Median
1385792|NCT01398956|Primary|Incidence of Treatment Emergent Adverse Events During the Entire Study Period||Through study completion, an average of 3 years|The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.|||Treatment Emergent Adverse Events|||Number
1385793|NCT01398943|Secondary|Pulse Wave Velocity|A measure of vascular stiffness at baseline and several hours after each experimental intervention.|Post PWV was taken approximately 90 min after baseline|Patients diagnosed with COPD compared to healthy age-matched controls.|||m/sec||Standard Deviation|Mean
1385795|NCT01398852|Primary|Changes in Corneal Curvature||24 MO|The CXL-003 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.||||||
1385796|NCT01398839|Primary|Changes in Corneal Curvature||6 Months|The CXL-002 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.||||||
1385797|NCT01398787|Primary|Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)|"The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1)."|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
1385798|NCT01398787|Primary|Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)|The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
1385799|NCT01398787|Primary|Subjective Rating of Initial Comfort|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
1385800|NCT01398787|Primary|Appearance Preference|The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
1385801|NCT01398787|Primary|Initial Comfort Preference|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
1385802|NCT01398787|Primary|Overall Preference|The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
1385803|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 5).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 5 of the Acquisition Phase."|Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)||||micro-Siemens (square rooted)||Standard Error|Mean
1385804|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 4).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 4 of the Early Extinction Phase."|Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)||||micro-Siemens (square rooted)||Standard Error|Mean
1385805|NCT01398475|Secondary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax)||Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.|||hours (h)||Full Range|Median
1385806|NCT01398475|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)||Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.|||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1402523|NCT01243320|Primary|Change In Glucose Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
1385807|NCT01398475|Primary|Pharmacokinetics: Plasma Concentration-Time Curve (AUC)|The area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state.|Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.|||nanomoles*hours per liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1385808|NCT01398410|Secondary|Cumulative Recurrent Rate of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.|Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)|The analysis was performed using Full Analysis Set, defined as all participants who received at least one dose of rabeprazole, with at least one post-initiation endoscopic assessment results, and showed no ulcers on baseline endoscopy; excluding participants from the newly-initiated rabeprazole groups of study E3810-J081-309.|||Percentage of participants||95% Confidence Interval|Number
1385809|NCT01398410|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.|For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)|The analysis was performed using Safety Analysis Set, defined as all participants who received at least one dose of rabeprazole.|||Percentage of participants|||Number
1385810|NCT01398358|Secondary|Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale|To assess self-regulation, teachers completed a modified 60-item version of the Social Competence and Behavior Evaluation (SCBE) scale.The SCBE assesses emotional and behavioral regulation difficulties typically seen in the preschool setting. It includes both positive (competence) and negative (emotional or behavioral problems) items, including internalizing (ie, anxious, sad) and externalizing (ie, oppositional) behaviors, both of which are indicators of poor behavioral self-regulation. The General Adaptation T-score assesses child overall emotional and behavioral self-regulation in the classroom setting. It is calculated by taking the mean of all 60 items for the SCBE questionnaire (with reverse scoring for questions capturing problem behavior) and then determining the corresponding t-score based on published tables. Higher scores indicate better self-regulation. The range for General Adaptation T-score is 30-70.|9 months||||change in t-score from pre to post||Standard Error|Mean
1385811|NCT01398358|Primary|Change in Body Mass Index Z-score|Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period|9 months|Seven of the 697 were excluded from analysis because they were missing both pre- and post- intervention BMI z-score. It was possible for a child to be included in the final analysis population even if they had not completed the follow-up portion of the study because the mixed model statistical method used could include their pre-intervention data.|||Z-Score||Standard Error|Mean
1385812|NCT01398176|Primary|Physiological Modifications to Gamma Delta T Cell Function|Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T cells express CD3.|4 weeks|Intent to treat|||percent of T lymphocytes||Standard Error|Mean
1385813|NCT01397890|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||exacerbations/participant/12 weeks||95% Confidence Interval|Least Squares Mean
1385814|NCT01397890|Secondary|Change in COPD Symptoms - Sputum|Change in Sputum symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||score on a scale||95% Confidence Interval|Least Squares Mean
1385815|NCT01397890|Secondary|Change in COPD Symptoms - Cough|Change in Cough symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||score on a scale||95% Confidence Interval|Least Squares Mean
1385816|NCT01397890|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||score on a scale||95% Confidence Interval|Least Squares Mean
1385817|NCT01397890|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
1385818|NCT01397890|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
1385819|NCT01397890|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
1385820|NCT01397890|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
1385821|NCT01397890|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
1385822|NCT01397890|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
1385823|NCT01397890|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
1385824|NCT01397890|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
1385825|NCT01397890|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
1385826|NCT01397890|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
1385827|NCT01397890|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
1385828|NCT01397890|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
1385829|NCT01397890|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385830|NCT01397890|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385831|NCT01397890|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385832|NCT01397890|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385849|NCT01397825|Secondary|Number of Participants With Clinically Significant Changes in Multigated Acquisition (MUGA)/ Echocardiogram (ECHO) [Phase 2]||From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
1385833|NCT01397890|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385834|NCT01397890|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385835|NCT01397890|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385836|NCT01397890|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
1385837|NCT01397851|Secondary|Self-reported Malaria Prevalence|Over two weeks before interview, collected through validation survey. Odds ratio calculated in accordance with NIH guidance http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)|Subset of study population selected for validation survey|||odds ratio|||Number
1385838|NCT01397851|Secondary|Increase in Maize Productivity|Increase in self-reported maize productivity (yield on maize plots divided by size of maize plots), collected through validation survey; calculated as maize productivity 2010-11 minus maize productivity 2009-10, measured in bags (ordinarily 50kg bags; however, kg measure not specified)|2009-2010 and 2010-2011 seasons (up to 2 years)|Subset of study population selected for validation survey|||bags (not further specified)||Standard Error|Mean
1385839|NCT01397851|Secondary|Contract Defaults|Defaults on input loans, as defined in the routine data collection system of the participating cotton outgrowing agribusiness. Odds ratios calculated in accordance with NIH guidance: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)||||odds ratio|||Number
1385840|NCT01397851|Primary|Cotton Yields|Farmer's cotton yields (kg delivered per household), as defined in the routine data collection system of the participating cotton outgrowing agribusiness|2010-2011 season (up to 1 year)||||kg||Standard Deviation|Mean
1385841|NCT01397825|Secondary|T1/2: Terminal Disposition Phase Half-life for Vincristine||Cycles 1 and 2 on Day prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as participants with sufficient dosing and concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine. Number analyzed is the number of participants with data available at the time-point. No data was collected for the alisertib 50 mg arm in Cycle 2.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1385842|NCT01397825|Secondary|AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for Vincristine||Cycles 1 and 2 on Day 1 prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as participants with sufficient dosing and concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine. Number analyzed is the number of participants with data available at the time-point. No data was collected for the alisertib 50 mg arm in Cycle 2.|||ng/mL*hr||Standard Deviation|Mean
1385843|NCT01397825|Secondary|AUCt: Area Under the Concentration-time Time Curve Over the Dosing Interval From Time 0 to Time t for Vincristine||Cycles 1 and 2 on Day 1 prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as all participants with sufficient dosing and vincristine concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine Number analyzed is the number of participants with data available at the given time-point.|||ng/mL*hr||Standard Deviation|Mean
1385844|NCT01397825|Secondary|Cmax: Maximum Plasma Concentration for Vincristine||Cycles 1 and 2 on Day 1 prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as all participants with sufficient dosing and vincristine concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine. Number analyzed is the number of participants with data available at the given time-point.|||ng/mL||Standard Deviation|Mean
1385845|NCT01397825|Secondary|AUCt: Area Under the Concentration Time Curve Over the Dosing Interval From Time 0 to Time t for Alisertib||Cycle 1 Days 1 and 7 prior to morning alisertib dose and multiple time-points (up to 12 hours) post-dose|Alisertib PK-Evaluable Population was defined as all participants with sufficient dosing and alisertib concentration-time data to permit non-compartmental PK analysis. Number analyzed is the number of participants with data available at the given time-point.|||nanomoles/liter*hour (nmol/L*hr)||Standard Deviation|Mean
1385846|NCT01397825|Secondary|Tmax: Time to First Occurrence of Cmax fo Alisertib||Cycle 1 Days 1 and 7 prior to morning alisertib dose and multiple time-points (up to 12 hours) post-dose|Alisertib PK-Evaluable Population was defined as all participants with sufficient dosing and alisertib concentration-time data to permit non-compartmental PK analysis. Number analyzed is the number of participants with data available at the given time-point.|||hours (hr)||Full Range|Median
1385847|NCT01397825|Secondary|Cmax: Maximum Plasma Concentration for Alisertib||Cycle 1 Days 1 and 7 prior to morning alisertib dose and multiple time-points (up to 12 hours) post-dose|Alisertib Pharmacokinetic (PK)-Evaluable Population was defined as all participants with sufficient dosing and alisertib concentration-time data to permit non-compartmental PK analysis. Number analyzed is the number of participants with data available at the given time-point.|||nanoMolar (nM)||Standard Deviation|Mean
1385848|NCT01397825|Secondary|Number of Participants With Clinically Significant Laboratory Tests Reported as Adverse Events [Phase 2]||From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
1385850|NCT01397825|Secondary|Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) [Phase 2]||From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
1385851|NCT01397825|Secondary|Number of Participants With Clinically Significant Vital Signs Findings [Phase 2]|Vital sign parameters: blood pressure, heart rate and temperature determined by the investigator to be clinically significant were reported as adverse events.|From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
1385852|NCT01397825|Secondary|Number of Participants With Treatment-Emergent Adverse Events [Phase 2]|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
1385853|NCT01397825|Secondary|Progression Free Survival (PFS) [Phase 2]|PFS was defined as the time from the date of first study drug administration to the date of first documentation of PD or death.|Duration of study until disease progression, approximately 2 years|The Phase 2 portion of the study was cancelled by the sponsor.||||||
1385854|NCT01397825|Secondary|Duration of Response (DOR) [Phase 2]|DOR was defined as the time from the date of first documentation of a response to the date of first documentation of Progressive Disease (PD).|Duration of study until disease progression, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
1385855|NCT01397825|Secondary|Complete Response Rate [Phase 2]|Complete response rate was defined as the percentage of participants with Complete Response (CR). CR was assessed by the investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease.|Duration of study until disease progression, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
1385856|NCT01397825|Secondary|Overall Response Rate as Assessed by the Investigator [Phase 1]|Overall Response Rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) as assessed by the investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Response-Evaluable Population was defined as all participants with measurable disease who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1385857|NCT01397825|Primary|Overall Response Rate [Phase 2]|Overall Response Rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) as assessed by the investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|At the end of Cycle 2, at the end of every second treatment cycle until 6 months, then every 12 weeks thereafter, approximately 2 years|The Phase 2 portion of the study was cancelled by the sponsor.||||||
1385858|NCT01397825|Primary|Number of Participants With Treatment-Emergent Adverse Events [Phase 1]|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
1385859|NCT01397825|Primary|Number of Participants With Clinically Significant Laboratory Tests Reported as Adverse Events [Phase 1]|Abnormal treatment-emergent Chemistry and Hematology Laboratory values determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
1385860|NCT01397825|Primary|Number of Participants With Clinically Significant Changes in Physical Examination Findings [Phase 1]|Abnormal Physical Examination findings determined by the investigator to be clinically significant were reported as Adverse Events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
1385861|NCT01397825|Primary|Number of Participants With Clinically Significant Changes in Multigated Acquisition (MUGA)/ Echocardiogram (ECHO) [Phase 1]|Abnormal changes in MUGA and ECHO findings determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
1385862|NCT01397825|Primary|Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) [Phase 1]|Abnormal ECGs findings determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
1385863|NCT01397825|Primary|Number of Participants With Clinically Significant Vital Signs Findings (Treatment Related and Unrelated) [Phase 1]|Vital sign parameters: blood pressure, heart rate and temperature determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
1385864|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385865|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385866|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385867|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385868|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385869|NCT01397786|Secondary|Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385870|NCT01397786|Secondary|Discontinuation Rate for Lack of Efficacy|Discontinuation rate for the participants who discontinued due to lack of efficacy were examined.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||percentage of participants|||Number
1385871|NCT01397786|Secondary|Response Rate|Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||percentage of participants|||Number
1385872|NCT01397786|Secondary|Mean Clinical Global Impression - Improvement Score|The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due to the drug treatment. All responses were compared to the participant's condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385873|NCT01397786|Secondary|Mean Change From Baseline in Personal and Social Performance Scale Total Score|The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385874|NCT01397786|Secondary|Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?” Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385875|NCT01397786|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385876|NCT01397786|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385877|NCT01397786|Secondary|Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score|The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS total score was sum of rating scores for 7 positive, 7 negative, and 16 general psychopathology subscale items of PANSS panel.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
1385878|NCT01397786|Primary|Percentage of Participants With Adverse Events (AEs)|A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.|From Baseline up to 52 Weeks|Safety sample included those participants who had at least one post-baseline efficacy evaluation for Positive and Negative Syndrome Scale (PANSS) total score.|||percentage of participants|||Number
1385879|NCT01397747|Primary|Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.|An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100*(multitarget DNA or FIT negative test/negative colonoscopy).|90 Days||||percent||95% Confidence Interval|Number
1385880|NCT01397617|Secondary|Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intention to treat analysis.|||percentage of surviving implants|Participants||Number
1385881|NCT01397617|Primary|The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.~Missing data was not imputed and not included in evaluation."|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.|||mm||Standard Deviation|Mean
1385938|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385882|NCT01397591|Secondary|Number of Participants With Adverse Events (Toxicity)|Toxicities and adverse experiences will be assessed at each visit using the NCI Common Toxicity Criteria for Adverse Events v4.0 Interim analyses on toxicity will be implemented based on the toxicity endpoints of the first 6 patients, and will be conducted sequentially 4 weeks after the treatment of each patient, or when serious toxicity has been observed for the patient, whichever comes earlier. we assume a non-informative prior distribution (Beta (0.001, 0.001)) for toxicity rate, and compute the posterior distribution of toxicity rate sequentially.|Days 1, 8, and 15 of each course and 4-6 weeks after final treatment||||participants|||Number
1385883|NCT01397591|Secondary|Disease Free Survival|The period of time between complete remission and recurrence of disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.||||||
1385884|NCT01397591|Secondary|Progression Free Survival|This outcome measure is defined as the length of time after treatment during which the patient survives with no sign of the disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.||||||
1385885|NCT01397591|Secondary|Overall Survival|This outcome measure is defined as the time from initiation of treatment to death due to any cause.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.||||||
1385886|NCT01397591|Primary|Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma|Based on International Working Group (IWG) criteria, recorded in four categories: Complete Response (CR), disappearance of all evidence of disease; Partial Response (PR), regression of measurable disease and no new sites of disease; Progressive Disease (PD), Any new lesion or increase by >= 50% of previously involved sites from nadir. Stable Disease (SD), failure to attain CR/PR or PD. A response is defined to be either CR/PR. A failure in response includes SD/PD.|Every 2 cycles during treatment and then every 3 months for 2 years||||participants|||Number
1385887|NCT01397461|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.~Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.~The SIRS is a severity index based on seven signs or symptoms:~Exudate/pus~Crusting~Erythema/inflammation~Tissue warmth~Tissue oedema~Itching~Pain~Each sign/symptom is rated on a scale from 0 to 6:~0 = absent~1 2 = mild 3 4 = moderate 5 6 = severe"|2 weeks||||percentage of participants|||Number
1385888|NCT01397448|Primary|Cumulative Recurrent Rates of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.|24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.|||Events/100 participants/24 weeks||95% Confidence Interval|Number
1385889|NCT01397448|Secondary|Cumulative Incidence of Bleeding Ulcers||24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.|||Events/100 participants/24 weeks||95% Confidence Interval|Number
1385890|NCT01397422|Secondary|Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8|The CGI-C consisted of a single question that assessed the investigator’s global impression of the subject’s change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject’s PD had improved or worsened (from marked worsening to marked improvement).|Baseline (Day 1) and Week 8|MITT population|||Participants|||Count of Participants
1385891|NCT01397422|Secondary|Change in Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8|The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4.|Baseline (Day 1) and Week 8|MITT population|||units on a scale||Standard Error|Least Squares Mean
1385892|NCT01397422|Secondary|Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary|A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit.|Baseline (Day 1) and Week 8|MITT population|||hours||Standard Error|Least Squares Mean
1385893|NCT01397422|Secondary|Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8|UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia.|Baseline (Day 1) and Week 8|MITT Population|||units on a scale||Standard Error|Least Squares Mean
1385894|NCT01397422|Secondary|Change in the Fatigue Severity Score (FSS) From Baseline to Week 8|The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.|Baseline (Day 1) and Week 8|MITT population|||units on a scale||Standard Error|Least Squares Mean
1385895|NCT01397422|Primary|Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8|The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.|Baseline (Day 1) and Week 8|Participants in the MITT population with available data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1402524|NCT01243320|Primary|Change In CreatinineBlood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
1385896|NCT01397409|Secondary|Stage 3: Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||letters||Standard Deviation|Mean
1385897|NCT01397409|Secondary|Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||microns||Standard Deviation|Mean
1385898|NCT01397409|Secondary|Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||letters||Standard Deviation|Mean
1385899|NCT01397409|Secondary|Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||microns||Standard Deviation|Mean
1385900|NCT01397409|Secondary|Stage 2: Time Between Second Treatment and Recurrence of Active Disease|Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.|32 Weeks|mITT Population|||days||Inter-Quartile Range|Median
1385901|NCT01397409|Primary|Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified-Intent-to-Treat (mITT) Population|||letters||Standard Deviation|Mean
1385902|NCT01397409|Primary|Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease|Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.|Baseline, Week 16|Per-protocol Population included all treated participants who received all scheduled treatments.|||days||Inter-Quartile Range|Median
1385903|NCT01397409|Primary|Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants.|||microns||Standard Deviation|Mean
1385904|NCT01397409|Primary|Highest Tolerated Dose (HTD) of AGN-150998|Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.|24 Weeks|Safety population included all treated participants.|||mg|||Number
1385905|NCT01397253|Secondary|Patient PCP Visits, Emergency Room Visits and Rehospitalizations Within 30 Days Post-discharge.|Details regarding patient PCP follow-up office appointments, ER visits and rehospitalizations occuring within 30 days post-discharge will be collected from the EMR.|Within 30 post-discharge from hospital|||||||
1385906|NCT01397253|Primary|Medication Errors at Hospital Discharge|Medication name, dose, and frequency of administration for patient pre-admission medications will be recorded. Medications received during the hospitalization and discharge medications will be obtained by medical record review following hospital discharge. Pre-admission medications will be compared to discharge medications and differences will be considered discharge medication variances. Two trained pharmacists will independently review medication variances to determine clinical indications or medication errors.|Approximately 1-30 days|Hospitalized medical patients with ≥2 comorbidities and ≥5 chronic medications, at a single center|||Errors|Participants||Number
1385907|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 8 weeks|Efficacy Population (104 participants)|||Participants|||Number
1385908|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks.|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.|||Participants|||Number
1385909|NCT01397084|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.|||Days with heartburn||Standard Deviation|Mean
1385910|NCT01397084|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline and 8 weeks|Efficacy Population (104 participants)|||Days with heartburn||Standard Deviation|Mean
1385911|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385912|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385913|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385914|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385915|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385916|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385917|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385918|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385919|NCT01396525|Secondary|Stent Thrombosis|Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target lesions|Participants|95% Confidence Interval|Number
1385920|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
1385921|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
1385922|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
1385923|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint|||percentage of target limbs|Participants||Number
1385924|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385925|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385926|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|18 months|ITT population.This analysis represents those subjects who were event free at this timepoint|||percentage of particpants|||Number
1385927|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this timepoint|||percentage of particpants|||Number
1385928|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
1385929|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
1385930|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
1385931|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint|||percentage of target limbs|Participants||Number
1385932|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385933|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385934|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385935|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint|||percentage of participants|||Number
1385936|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385937|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|2 years|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1385939|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint.|||percentage of participants|||Number
1385940|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
1385941|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
1385942|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
1385943|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|3 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1385944|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|2 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1385945|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1385946|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1385947|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
1385948|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
1385949|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
1385950|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
1385951|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1385952|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1385953|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint|||percentage of target vessels|Participants||Number
1385954|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint|||percentage of target vessels|Participants||Number
1385955|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.|||percentage of target vessels|Participants||Number
1385956|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.|||percentage of target vessels|Participants||Number
1385957|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.|||percentage of target vessels|Participants||Number
1385958|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint|||percentage of target vessels|Participants||Number
1385959|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
1385960|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
1385961|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
1385971|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385962|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1385963|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
1385964|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
1385965|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
1385966|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1385967|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385968|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385969|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385970|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385981|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1402525|NCT01243320|Primary|Change in Urea Nitrogen Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
1385972|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385973|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385974|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385975|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
1385976|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385977|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385978|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385979|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1385980|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|Pre-procedure|ITT population, per subject analysis|||score on a scale||Standard Deviation|Mean
1385982|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385983|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385984|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between Baseline and 1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385985|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and Post-procedure|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385986|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385987|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385988|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385989|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385990|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385991|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1385992|NCT01396525|Secondary|Procedure Success|Procedure success is defined as technical success (device success and attainment of a final residual stenosis of < 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population, per subject analysis|||percentage of participants||95% Confidence Interval|Number
1385993|NCT01396525|Secondary|Technical Success|Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of < 30% by QA or as reported by the investigator.|Acute: from beginning of index procedure to end of procedure|ITT population, per lesion analysis|||percentage of target lesions|Participants|95% Confidence Interval|Number
1385994|NCT01396525|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|Acute: from beginning of index procedure to end of procedure|ITT population, per device analysis. Included 210 stents plus 1 stent inserted but not implanted due to device malfunction, 2 stents excluded due to inappropriate sizing (stents were not implanted), 1 stent excluded as stent was not implanted per physician's choice and had no device malfunction.|||percentage of devices|Participants|95% Confidence Interval|Number
1385995|NCT01396525|Primary|Major Adverse Event (MAE)|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants||95% Confidence Interval|Number
1386022|NCT01396395|Secondary|Number of Nitroglycerin Tablets Consumed in a Week||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||tablets per week||Inter-Quartile Range|Median
1386023|NCT01396395|Secondary|Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||subjects|||Number
1385996|NCT01396512|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1385997|NCT01396512|Secondary|Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1385998|NCT01396512|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|"Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).~JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)"|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1385999|NCT01396512|Primary|Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.|Day 28 post-vaccination|Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.|||Percentage of Participants|||Number
1386000|NCT01396447|Secondary|Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6|"The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a normal state and 7 indicating among the most extremely ill participants. A higher score indicates greater illness. A negative change score indicates improvement."|Baseline to Week 6|Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale.|||units on a scale||Standard Error|Least Squares Mean
1386001|NCT01396447|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6|The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.|Baseline to Week 6|Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale.|||units on a scale||Standard Error|Least Squares Mean
1386002|NCT01396434|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.|Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period|Participants who received at least 1 dose of 13vPnC.|||participants|||Number
1386003|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score|The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety [G2], guilt feelings [G3], tension [G4], depression [G6]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386004|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score|The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement [P4], hostility [P7], uncooperativeness [G8], poor impulse control [G14]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386406|NCT01392625|Secondary|Measurement of Changes in Global Ejection Fraction|Measurement of regional left ventricular function, end diastolic and end systolic volume, measured by MRI, and or CT, and echocardiogram.|Baseline, 6 month and 12 month||||% ratio of the SV to Global EDV||Standard Deviation|Mean
1386005|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score|The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization [P2], difficulty in abstract thinking [N5], mannerisms and posturing [G5], disorientation [G10], poor attention [G11], disturbance of violation [G13], preoccupation [G15]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386006|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score|The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect [N1], emotional withdrawal [N2], poor rapport [N3], passive/apathetic social withdrawal [N4], lack of spontaneity and conversation flow [N6], motor retardation [G7], active social avoidance [G16]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386007|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score|The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions [P1], hallucinatory behaviour [P3], grandiosity [P5], suspiciousness [P6], stereotyped thinking [N7], somatic concern [G1], unusual thought content [G9], lack of judgment and insight [G10]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386008|NCT01396421|Secondary|Discontinuation Rate for Lack of Efficacy at Week 6||Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Percentage of participants|||Number
1386009|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score|The PEC consists of 5 PANSS items (excitement [P4], hostility [P7], tension [G4], uncooperativeness [G8], and poor impulse control [G14]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386010|NCT01396421|Secondary|Response Rate at Week 6|Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Percentage of participants|||Number
1386011|NCT01396421|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6|The participant’s overall improvement was rated using the CGI-I. The rater or study physician rated the participant’s total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant’s condition at screening/baseline. Response choices were: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1386012|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score|For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386013|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score|For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386407|NCT01392625|Secondary|Measurement of Changes in 6 Minute Walk|Measurement of Six-minute walk test during the 12 month follow-up period|Baseline, 6 month and 12 month||||meters||Standard Deviation|Mean
1386014|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)|The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 122, 55 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386015|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|The severity of illness was rated using the CGI-S. To perform this assessment, the rater or study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.|Baseline to Week 1, 2, 3, 4 and 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386016|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 1, 2, 3, 4, 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386017|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 124, 56 and 109 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386018|NCT01396421|Primary|Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 134, 132, 62 and 124 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
1386019|NCT01396395|Secondary|Number of Subjects Who Showed Compliance to Nicorandil|Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated.|Baseline up to 12 Weeks|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.|||subjects|||Number
1386020|NCT01396395|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.|||subjects|||Number
1386021|NCT01396395|Secondary|Walk Distance in Six Minute Walk (6-MWT) Test at Week 12|The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.|||meters||Standard Deviation|Mean
1386024|NCT01396395|Secondary|Frequency of Angina Attack|The total number of times angina attacks occurred within a week (number of times/week)|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||angina attacks per week||Inter-Quartile Range|Median
1386025|NCT01396395|Secondary|Number of Subjects Experienced Angina Attack||Baseline up to 12 Weeks|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||subjects|||Number
1386026|NCT01396395|Secondary|ECG QT Dispersion|The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12‐lead ECG.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||milliseconds||Standard Deviation|Mean
1386027|NCT01396395|Secondary|Number of Arrhythmia Occurred Within 24 Hours|The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||beats per 24 hours||Standard Deviation|Mean
1386028|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on ‘normal-to-normal’ (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||millisecond square (ms^2)||Standard Deviation|Mean
1386029|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Time Domain|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on ‘normal-to-normal’ (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means.|At Week 12|"FAS included all randomized subjects who received at least one dose of study treatment. n signifies the number of subjects evaluable for each category in each group for this outcome measure, respectively."|||millisecond||Standard Deviation|Mean
1386030|NCT01396395|Secondary|Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test|The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||percentage of subjects|||Number
1386031|NCT01396395|Secondary|Change From Baseline in Longest Duration of ST Segment Depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||seconds||Standard Deviation|Mean
1386032|NCT01396395|Secondary|Change From Baseline in Maximum ST-depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||millimeter||Standard Deviation|Mean
1386033|NCT01396395|Secondary|Change From Baseline in Total Myocardial Ischemic Burden at Week 12|The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||millimeter*minutes||Standard Deviation|Mean
1386034|NCT01396395|Primary|Number of Myocardial Ischemia Attacks in 24 Hours|Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (>=) 0.1 millivolts (mV), and lasted for >= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||ischemic attacks per 24 hours||Standard Deviation|Mean
1386035|NCT01396382|Primary|Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan|Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).|at 1 year|A major change in management is defined as:planned surgery cancelled, added, or a different type of surgery was planned, or a medication was added or stopped, or a new treatment modality (e.g. radiation) was added. A minor change was adjustment to planned surgery or radiation field, or in current medication dosage.|||participants|||Number
1386408|NCT01392625|Secondary|Measurement of Changes in Peak VO2|Measurement of Peak oxygen consumption (Peak VO2) by treadmill determination during the 12 month follow-up period.|Baseline, 6 month and 12 month||||ml/kg/min||Standard Deviation|Mean
1386036|NCT01396382|Secondary|Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability|Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life‐threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.|at 1 year||||participants|||Number
1386037|NCT01396317|Secondary|Total Number of Relapses/Recurrences||12 months||||Incidents|||Number
1386038|NCT01396317|Secondary|The Cumulative Dose of Prednisone||6, 12 and 15 months from trial entry||||milligrams||Standard Deviation|Mean
1386039|NCT01396317|Secondary|Proportion of Patients Who Develop Disease Relapses|Relapse was defined as the reappearance of signs and symptoms of PMR, accompanied by an increasing erythrocyte sedimentation rate and/or C-reactive\ protein level attributable to disease activity. Recurrence was similarly defined as the return of PMR symptoms in conjunction with elevations in levels of inflammation markers, occurring 1 month after discontinuation of GC therapy.|6, 12 and 15 months from trial entry||||Participants|||Count of Participants
1386040|NCT01396317|Secondary|Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence||12 and 15 months from trial entry||||Participants|||Count of Participants
1386041|NCT01396317|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"The co-primary endpoints for this study include evaluations of safety and tolerability:~• Safety and tolerability of Tocilizumab will be evaluated during the fifteen-month study period by the monitoring of adverse events and immunogenicity surveillance"|15 months||||Number of Adverse Events|||Number
1386042|NCT01396317|Primary|Proportion of Patients in Disease Remission at Six Months From Trial Entry|"The co-primary endpoints for this study include efficacy:~• Efficacy will be defined by the proportion of patients in Disease Remission (DR) off corticosteroids, without relapse or recurrence, at six months from trial entry~Relapse was defined as the reappearance of signs and symptoms of PMR, accompanied by an increasing erythrocyte sedimentation rate and/or C-reactive protein level attributable to disease activity. Recurrence was similarly defined as the return of PMR symptoms in conjunction with elevations in levels of inflammation markers, occurring 1 month after discontinuation of glucocorticoid therapy."|Six months||||Participants|||Count of Participants
1386043|NCT01396265|Secondary|Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)|V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||Litres||Geometric Coefficient of Variation|Geometric Mean
1386044|NCT01396265|Secondary|Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)|CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1386045|NCT01396265|Secondary|Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo)|MRTpo represents the mean residence time of the analyte in the body after oral administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||hours||Geometric Coefficient of Variation|Geometric Mean
1386046|NCT01396265|Secondary|Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞)|%AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||percentage of AUCtz-∞||Geometric Coefficient of Variation|Geometric Mean
1386047|NCT01396265|Secondary|Area Under Curve From 0 to 24 h (AUC0-24)|AUC0-24 represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (h)|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1386048|NCT01396265|Secondary|Terminal Half-life of Afatinib in Plasma (t1/2)|t1/2 represents the terminal half-life of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||hours||Geometric Coefficient of Variation|Geometric Mean
1386049|NCT01396265|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)|tmax represents the time from dosing to the maximum concentration of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||hours||Full Range|Median
1386290|NCT01393730|Secondary|Change in Circulating Tumor Cells (CTCs) Levels|CTCs were measured based on established methods.|Pairs of patients' samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|Data were not collected for this secondary endpoint.||||||
1386050|NCT01396265|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1386051|NCT01396265|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1386052|NCT01396265|Primary|Area Under Curve From 0 to Infinity Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1386053|NCT01396239|Post-Hoc|Frequency of AEs Related to Eteplirsen|Frequency of AEs that the study physician considered to be any of the following: Related; Possibly related; or Probably related to eteplirsen.|24 Weeks||||Number of patients|||Number
1386054|NCT01396239|Post-Hoc|Adverse Events >30%|Adverse events that occurred in >30% of the overall patient population across treatment arms.|24 Weeks||||Number of patients|||Number
1386055|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Modified Intent to Treat Population (mITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment of the 6-MWT distance. Change from baseline: 6 Minute Walk Test (6MWT) - modified Intent-to-Treat population (mITT).|24 weeks|The mITT population excludes 2 patients in the 30mg/kg arm who showed rapid disease progression within weeks of enrollment, and were unable to complete assessments that required ambulation at or beyond Week 24.|||Meters||Standard Error|Mean
1386056|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Intent to Treat Population (ITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment Change from baseline: 6 Minute Walk Test (6MWT) - Intent to Treat population (ITT)|24 weeks||||Meters||Standard Error|Mean
1386057|NCT01396239|Primary|Change in the Number (%) of Dystrophin Positive Fibers|The primary efficacy endpoint will be based on the pre-treatment and post-treatment change in the number (%) of dystrophin positive fibers as measured in the muscle biopsy tissue on immunohistochemistry (IHC).|After 12 weeks for 4 patients who received 50 mg/kg and 2 patients who received placebo. After 24 weeks for 4 patients who received 30 mg/kg and 2 patients who received placebo.|The sample size for the study was selected based on Proof of Principal approach.|||percentage of dystrophin Pos. fibers||Full Range|Least Squares Mean
1386058|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|PP|||msec||Standard Deviation|Mean
1386059|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|PP|||msec||Standard Deviation|Mean
1386060|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Per Protocol (PP)|||msec||Standard Deviation|Mean
1386061|NCT01396226|Secondary|RR Interval|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386062|NCT01396226|Secondary|QRS Duration|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386063|NCT01396226|Secondary|PR Interval|Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386064|NCT01396226|Secondary|HV Interval|Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386065|NCT01396226|Secondary|AH Interval|Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386066|NCT01396226|Secondary|PA Interval|Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386067|NCT01396226|Secondary|Atrio-ventricular Effective Refractory Period|Change from observation before IP infusion to during 1st and 2nd LAERP Mean|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386068|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386069|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
1386070|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Full A analysis Set (FAS)|||msec||Standard Deviation|Mean
1386071|NCT01396187|Secondary|Average Plasma Concentration (Cav) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Geometric Mean
1386072|NCT01396187|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Geometric Mean
1386073|NCT01396187|Secondary|Volume of Distribution of PF-05231023 at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. PF-05231023 with C-terminal and N-terminal Vss at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."|||liter||Standard Deviation|Geometric Mean
1386074|NCT01396187|Secondary|Apparent Clearance (CL) of PF-05231023 at Steady State|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants who received PF-05231023 with C-terminal and N-terminal CL at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||liter per hour||Standard Deviation|Geometric Mean
1386075|NCT01396187|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023 at Steady State|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."|||hour||Standard Deviation|Mean
1386076|NCT01396187|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF- 05231023|Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 25) divided by Cmax at first dose (Day 1). Participants who received PF-05231023 with C-terminal and N-terminal Rac,Cmax at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Geometric Mean
1386077|NCT01396187|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval of PF-05231023 (Rac)|Rac was obtained from AUCtau at steady state (Day 25) divided by AUCtau after single dose (Day 1). AUCtau was the area under the concentration-time profile from time zero to end of dosing interval, where tau = 72 hours for Day 1 and tau = 96 hours for Day 25. Participants who received PF-05231023 with C-terminal and N-terminal Rac at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Geometric Mean
1386078|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Geometric Mean
1386079|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Tmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hour||Full Range|Median
1386080|NCT01396187|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05231023 at Steady State|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. Participants who received PF-05231023 with C-terminal and N-terminal AUClast at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
1386093|NCT01396161|Secondary|Renal Clearance (CLr)|CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||mL/min||Standard Deviation|Mean
1386081|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
1386082|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Participants who received PF 05231023 with C-terminal and N-terminal Cmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1386083|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1386084|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|Pharmacokinetic (PK) parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1386085|NCT01396187|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6* LLN or >1.5* ULN.|Baseline up to Day 32|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1386086|NCT01396187|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1386087|NCT01396187|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mm Hg), supine diastolic BP (DBP) <50 mm Hg, supine pulse rate <40 beats per minute (bpm), > 120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mm Hg and maximum increase or decrease from baseline in supine DBP >=20 mm Hg.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1386088|NCT01396187|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities were reported.|Baseline up to Day 42|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1386089|NCT01396187|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 77 which were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1386090|NCT01396187|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure, pulse rate and body temperature. Criteria for abnormal physical findings was based on investigator’s discretion and were reported as adverse event (AE), as planned.|Baseline up to Day 42|Physical examination data reported in this study was for identification of adverse events and were reported as adverse event in the AE section.||||||
1386091|NCT01396161|Secondary|Urinary Recovery|Percentage of PF-05175157 excreted unchanged in urine over the dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||percentage||Standard Deviation|Mean
1386092|NCT01396161|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|It was not possible to calculate data for half-life as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the half-life.||||||
1402526|NCT01243320|Primary|Change in Carbon Dioxide Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
1386094|NCT01396161|Secondary|Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)|Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]).|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||ratio||Standard Deviation|Mean
1386095|NCT01396161|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||µg times (*)hr divided by mL (µg *hr/mL)||Standard Deviation|Mean
1386096|NCT01396161|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Parameter (PKP) Analysis Population: all enrolled participante who received at least 1 dose of PF05175157 and had at least 1 PKP of interest calculated;Number of Participants Analyzed (N): number of participants with evaluable data|||hours (hrs)||Full Range|Median
1386097|NCT01396161|Secondary|Maximum Observed Plasma Concentration (Cmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Concentration (PKC) Analysis Population: all enrolled participants who received at least 1 dose of PF-05175157 and had at least 1 concentration value reported. Number of Participants Analyzed (N): number of participants with evaluable data|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
1386098|NCT01396161|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|2 weeks|Safety Analysis Set: all participants who received at least 1 dose of study medication (PF-05175157 or placebo).|||participants|||Number
1386099|NCT01396148|Secondary|Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Safety Endpoint (e.g., Absolute Neutrophil Count) Was Observed||Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|Due to low number of enrolled participants (n=6), there was insufficient data to perform any type of pharmacokinetic/pharmacodynamic modeling to obtain EC50 values, hence data is not reported.||||||
1386100|NCT01396148|Secondary|Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Efficacy Parameter (e.g., Sum of Largest Diameters for Target Tumors) Was Observed||Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|Due to low number of enrolled participants (n=6), there was insufficient data to perform any type of pharmacokinetic/pharmacodynamic modeling to obtain EC50 values, hence data is not reported.||||||
1386101|NCT01396148|Secondary|Pearson Correlation Coefficient Between Progression Free Survival With Total Drug (Sunitinib + SU012662) Concentration|Pearson correlation coefficient between Progression Free Survival (PFS) with total drug (Sunitinib + SU012662) concentration at Day 28 of Cycle 1 was calculated. PFS was defined as time (in months) from date of enrolment to the first documentation of disease progression or to death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days|The PK population included all treated participants with at least one PK observation.|||correlation coefficient|||Number
1386102|NCT01396148|Secondary|Progression Free Survival for PK Subgroups|Progression free survival was defined as time (in months) from date of enrollment to the first documentation of disease progression or to death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The PK evaluable participants were assessed according to 2 PK subgroups created on Day 28 of Cycle 1: those with total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) value less than (<) the median Ctrough value(lower exposure) and those with total drug (sunitinib + SU012662) Ctrough values greater than or equal to (>=) the median Ctrough value(higher exposure).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The PK population included all treated participants with at least one PK observation.|||months||95% Confidence Interval|Median
1386103|NCT01396148|Secondary|Number of Participants With Stable Disease (SD), Partial Response (PR), Complete Response (CR) and Progressive Disease (PD) for PK Sub-groups|SD:when there is no sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR: as at least 30% decrease in the sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non-target lesions not increased or absent. CR: disappearance of all lesions (target and non-target). PD:at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Participants with SD, PR, CR and PD responses were assessed according to 2 PK subgroups created on Day 28 of Cycle 1: those with total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) value less than (<) the median Ctrough value(lower exposure) and those with total drug (sunitinib + SU012662) Ctrough values greater than or equal to (>=) the median Ctrough value(higher exposure).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The PK population included all treated participants with at least 1 PK observation.|||participants|||Number
1386104|NCT01396148|Secondary|Pearson Correlation Coefficient Between Percent Change From Baseline in Vital Sign Results With Total Drug (Sunitinib + SU012662) Concentration|Pearson correlation coefficient between percent change from baseline in vital sign results with total drug (Sunitinib + SU012662) concentration were calculated on Day 28 of Cycles 1, 2, and 3. Vital signs included systolic blood pressure and diastolic blood pressure.|Baseline, Day 28 of Cycle 1, Cycle 2 and Cycle 3 (each cycle was of 42 days)|The PK population included all treated participants with at least one PK observation.|||correlation coefficient|||Number
1386105|NCT01396148|Secondary|Pearson Correlation Coefficient Between Percent Change From Baseline in Laboratory Parameters With Total Drug (Sunitinib + SU012662) Concentration|Pearson correlation coefficient between percent change from baseline in laboratory parameters with total drug (Sunitinib + SU012662) concentration were calculated on Day 28 of Cycles 1, 2, and 3. Laboratory parameters included absolute neutrophil count, platelet count, lymphocyte count and hemoglobin.|Baseline, Day 28 of Cycle 1, Cycle 2 and Cycle 3 (each cycle was of 42 days)|The PK population included all treated participants with at least one PK observation.|||correlation coefficient|||Number
1386106|NCT01396148|Secondary|Number of Participants With Adverse Events Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) for Pharmacokinetic (PK) Subgroups|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE version 4.0, Grade1= asymptomatic or mild symptoms, Grade 2= Moderate;local or noninvasive intervention indicated; Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. Participants with any of the Grade 1 to Grade 5 AEs were reported. The PK evaluable participants were divided into 2 PK subgroups on Day 28 of Cycle 1: those with total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) value less than (<) the median Ctrough value(lower exposure) and those with total drug (sunitinib + SU012662) Ctrough values greater than or equal to (>=) the median Ctrough value(higher exposure).|Cycle 1 Day 28 up to Cycle 3 (each cycle 42 days)|The PK subgroup analysis set included all treated participants with at least 1 PK observation.|||participants|||Number
1386107|NCT01396148|Secondary|Overall Survival|Overall survival was defined as time (in months) from enrollment to the date of death due to any cause. Analysis was performed using Kaplan-Meier method.|Baseline until death or discontinuation from the study whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The full analysis set included all enrolled participants regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1386108|NCT01396148|Secondary|Progression-Free Survival|Progression free survival was defined as time (in months) from date of enrollment to the first documentation of disease progression or to death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The full analysis set included all enrolled participants regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1386109|NCT01396148|Secondary|Duration of Response|Duration of response was defined as time (in months) from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or death due to any cause. Confirmed response were those that persisted on repeat imaging study for at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and non-target). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non-target lesions not increased or absent. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|Analysis was performed on a subset of FAS which included participants who had a confirmed CR or PR. Since, none of the participants had confirmed CR or PR, hence duration of response was not analyzed.||||||
1386110|NCT01396148|Secondary|Number of Participants With Objective Response|Objective response in participants was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed response were those that persisted on repeat imaging study for at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and non-target). PR was defined as at least 30 percentage (%) decrease in the sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non-target lesions not increased or absent.|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The full analysis set included all enrolled participants regardless of what treatment, if any, was received.|||participants|||Number
1386111|NCT01396148|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant laboratory abnormalities: Hemoglobin (Hb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1386112|NCT01396148|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1386152|NCT01396044|Primary|Empiric Antibiotic Duration||During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)|All patients who received at least one day of empirical antibiotics during their ICU admission.|||days||Inter-Quartile Range|Median
1386113|NCT01396148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. Treatment-emergent events are events between first dose of study drug and up to end of study (up to Cycle 18) that were absent before treatment or that worsened relative to pretreatment state. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1386114|NCT01396148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study (up to Cycle 18) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs.|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1386115|NCT01396148|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose AUC(0-8) for Sunitinib and Its Metabolite|AUC(0-8) was defined as area under the plasma concentration time-curve from time zero to 8 hours post dose. SU012662 is the metabolite of Sunitinib.|Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|The PK population included all treated participants with at least one PK observation.|||nanograms*hour per milliliter (ng*hr)/mL||Geometric Coefficient of Variation|Geometric Mean
1386116|NCT01396148|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Sunitinib and Its Metabolite|SU012662 is the metabolite of Sunitinib.|Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|The PK population included all treated participants with at least one PK observation.|||hours||Full Range|Median
1386117|NCT01396148|Primary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib and Its Metabolite|SU012662 is the metabolite of Sunitinib.|Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|The pharmacokinetic (PK) population included all treated participants with at least one PK observation.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1386118|NCT01396148|Primary|Estimated Oral Clearance (CL/F) for Sunitinib|Data for this endpoint will be estimated and reported separately as part of the Non-linear Mixed Effects Modeling analysis, and will be provided once available.|Weeks 1-18|||||||
1386119|NCT01396148|Primary|Estimated Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC24) for Sunitinib and Its Active Metabolite SU012662|Data for this endpoint will be estimated and reported separately as part of the Non-linear Mixed Effects Modeling analysis, and will be provided once available.|Weeks 1-18|||||||
1386120|NCT01396148|Primary|Estimated Steady-state Maximum Plasma Concentration (Cmax) for Sunitinib and Its Active Metabolite SU012662|Data for this endpoint will be estimated and reported separately as part of the Non-linear Mixed Effects Modeling analysis, and will be provided once available.|Weeks 1-18|||||||
1386121|NCT01396083|Secondary|Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline|The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment|||Participants|||Number
1386122|NCT01396083|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis|||Units on a scale||Standard Deviation|Mean
1386123|NCT01396083|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.|||Units on a scale||Standard Deviation|Mean
1386124|NCT01396083|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Score on a scale||Standard Deviation|Mean
1386163|NCT01395914|Primary|Percentage of Participants With Treatment-emergent Adverse Events|To Evaluate the Safety and Tolerability of Anamorelin HCl.|Over the 12-week treatment period|Safety Population, defined as patients who received any extension trial study drug.|||percentage of participants|||Number
1386125|NCT01396083|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||µm||Standard Deviation|Mean
1386126|NCT01396083|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||letters||95% Confidence Interval|Least Squares Mean
1386127|NCT01396083|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Time to event (Days)||95% Confidence Interval|Median
1386128|NCT01396083|Secondary|Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Participants|||Number
1386129|NCT01396083|Secondary|Mean BCVA Change at Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||95% Confidence Interval|Least Squares Mean
1386130|NCT01396083|Primary|Mean Average BCVA Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||Standard Deviation|Mean
1386131|NCT01396070|Secondary|Overall Non-Evaluable Response|"Overall Non-Evaluable Response of full patient population~3 subjects were not evaluable."|4 weeks||||Participants|||Count of Participants
1386132|NCT01396070|Secondary|Overall Partial Response Rate|"Overall Partial Response Rate (PR) in this study population.~3 subjects were not evaluable."|2 years||||Participants|||Count of Participants
1386133|NCT01396070|Secondary|Overall Stable Disease Rate|"Overall Stable Disease Rate (SD) in this study population.~3 subjects were not evaluable."|2 years||||Participants|||Count of Participants
1386134|NCT01396070|Primary|Overall Response Rate (ORR)|Overall response rate of brentuximab vedotin in this study population.|2 years|The percentage was calculated by adding Complete response (CR) + Partial Response (PR) = Overall rate. 3 subjects were not evaluable.|||percentage|||Number
1386135|NCT01396057|Secondary|Rate of the Internal Ocular Pressure (IOP)|The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment|||Participants|||Number
1386136|NCT01396057|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis|||Units on a scale||Standard Deviation|Mean
1386137|NCT01396057|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.|||Units on a scale||Standard Deviation|Mean
1386164|NCT01395901|Secondary|Proportion of Patients Without Nausea (Patient Aged > 6 Years)||0-24 hours after T0|The Full Analysis Set (FAS) population aged ≥ 6 years|||percentage of patients||95% Confidence Interval|Number
1386165|NCT01395901|Secondary|Proportion of Patients Without Antiemetic Rescue Medication|Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
1386138|NCT01396057|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Score on a scale||Standard Deviation|Mean
1386139|NCT01396057|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||µm||Standard Deviation|Mean
1386140|NCT01396057|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||95% Confidence Interval|Least Squares Mean
1386141|NCT01396057|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Time to event (Days)||95% Confidence Interval|Median
1386142|NCT01396057|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Participants|||Number
1386143|NCT01396057|Secondary|Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters (EDTRS)||95% Confidence Interval|Least Squares Mean
1386144|NCT01396057|Primary|Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||Standard Deviation|Mean
1386145|NCT01396044|Secondary|Standardized Mortality Ratio||Hospital admission|All patients treated with at least one day of empirical antibiotics.|||observed/expected deaths||95% Confidence Interval|Mean
1386146|NCT01396044|Secondary|Proportion of Patients-days on Which Empirical Antibiotics Were Used|Proportion of patients-days on which empirical antibiotics were used|ICU admission|All patients who received at least one day of empirical antibiotics.|||Number of patient-days|||Number
1386147|NCT01396044|Secondary|Proportion of Successful Prompts|"Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred~Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed"|During ICU admission, an average of 5 days (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.|||proportion of patient-days|||Number
1386148|NCT01396044|Secondary|Ventilator-free Days|Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.|During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.|||days||Inter-Quartile Range|Median
1386149|NCT01396044|Secondary|Length of Stay||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.|||days||Inter-Quartile Range|Median
1386150|NCT01396044|Secondary|Hospital Mortality||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirican antibiotics during ICU admission|||number of deaths|||Number
1386151|NCT01396044|Primary|Proportion of Empiric Antibiotics|The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).|ICU admission|All patients who received at least one day of empirical antibiotics during their ICU admission.|||proportion of antibiotic-days||Standard Deviation|Mean
1386153|NCT01396005|Secondary|Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued on Day 6.|||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1386154|NCT01396005|Secondary|AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).|||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1386155|NCT01396005|Primary|Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued from study on Day 6.|||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1386156|NCT01396005|Primary|AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).|||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1386157|NCT01396005|Primary|Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1386158|NCT01396005|Primary|Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir|||(ng.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1386159|NCT01395966|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study ( up to 22 days)||||days||95% Confidence Interval|Median
1386160|NCT01395914|Secondary|Change in A/CS Domain Score|"Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score is a 12-item scale. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial||||scores on a scale||Standard Error|Least Squares Mean
1386161|NCT01395914|Secondary|Change in Handgrip Strength of the Non-Dominant Hand||Change in HGS from baseline of the original trial through Week 12 of this extension trial.|Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
1386162|NCT01395914|Secondary|Change in Body Weight||Change in body weight from baseline of the original trial through Week 12 of this extension trial.|Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
1386166|NCT01395901|Secondary|Proportion of Patients Without Emetic Episodes|An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
1386167|NCT01395901|Secondary|Proportion of Patients With no Vomiting|Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
1386168|NCT01395901|Primary|Proportion of Patients With Complete Response|Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) included all randomized patients who received the active study drug, general anesthesia and surgery (evaluable patients). Following the intent-to-treat principle, patients were assigned to the study treatment arm according to their randomized treatment.|||percentage of patients||95% Confidence Interval|Number
1386169|NCT01395888|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of Eh/2pR, where E is Young’s modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and p is the blood density. Change from Baseline was calculated as the Day 84 value minus the Baseline value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking status at screening, geographical region, Baseline aPWV, and interaction terms of Baseline by visit and treatment by visit.|Baseline to Day 84 (Early Withdrawal)|Intent-to-Treat (ITT) Population: all participants (par.) who were randomized to and received >=1 dose of randomized medication in the TP. The analysis model included all par. in the ITT Population without missing covariate information (MCI) and with >=1 post-BL measurement. Par. presented represent those with data available at Day 84 without MCI.|||meters per second (m/sec)||Standard Error|Least Squares Mean
1386170|NCT01395823|Primary|EPO Dose|The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.|Baseline, 6 months||||units/week||Inter-Quartile Range|Median
1386171|NCT01395810|Secondary|Incidence of Serious Adverse Events (SAEs)|AEs were summarized by frequency of events and frequency of patients with any event. Incidence of serious AEs was expressed as number of serious AEs per subject years of exposure (total number of events /total time in trial).|From Day 1 up to 2 years|Safety Analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Events per subject year of exposure|||Number
1386172|NCT01395810|Secondary|Incidence of Adverse Events (AEs)|AEs were summarized by frequency of events and frequency of patients with any event. Incidence of AEs was expressed as number of AEs per subject years of exposure (total number of events /total time in trial).|From Day 1 up to 2 years|Safety Analysis Set consisted of all subjects who were exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Events per subject year of exposure|||Number
1386173|NCT01395810|Secondary|FIX Trough Levels|During the trial, the pre-dose FIX levels was measured with the one-stage clotting assay. Measurements taken at least 5 days and no more than 10 days after last dose as well as at least 14 days after last bleeding episode were included in this analysis. The mean FIX trough levels were estimated based on the mixed effects model on the log-transformed plasma concentration with subject as a random effect. The mean FIX trough level was presented back-transformed to the natural scale.|From Day 1 up to 2 years|Full analysis set consisted of all subjects exposed to nonacog beta pegol. This endpoint was analysed only for the prophylaxis arms (i.e.,10 IU/kg, 40 IU/kg). No pre-dose measurements were collected for patients on 80 IU/kg every second week prophylaxis.|||IU/mL||95% Confidence Interval|Mean
1386174|NCT01395810|Secondary|Number of Bleeding Episodes During Routine Prophylaxis|Annualized bleeding rate is the total number of bleeding episodes/total exposure time. It is analysed by a Poisson regression model with dose as a factor allowing for over-dispersion and using treatment duration as an offset. Median annualized bleeding rate is the median of individual annualized bleeding rates. Numbers are based on the treatment arm at the time of each bleed.|From Day 1 up to 2 years|Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||bleeds/patient/year||Inter-Quartile Range|Median
1386175|NCT01395810|Secondary|Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)|"The haemostatic effect was evaluated by a four-point scale where an excellent or good outcome translated into a successful treatment, and a moderate or poor outcome was considered a treatment failure. The values mentioned below do not include bleeds with missing response."|From Day 1 up to 2 years|Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Percentage of bleeding episodes|Bleeding episodes||Number
1386176|NCT01395810|Primary|Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units)|"The primary endpoint was incidence of inhibitors against coagulation factor nine (FIX) defined as titre~≥0.6 Bethesda unit (BU). Number of subjects who developed inhibitors against FIX are reported."|From Day 1 up to 2 years|Safety Analysis Set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Patients with inhibitory antibodies|||Number
1386177|NCT01395797|Secondary|Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.|"Visual analog scale ratings of Liking reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely)."|Following 2 weeks of Pioglitazone (PIO) maintenance.||||units on a scale||Standard Error|Mean
1386244|NCT01394211|Secondary|Proportion of Patients Achieving Sustained Decrease in Ki-67||12 weeks from the initiation of neoadjuvant therapy|Participants withdrew from participation||||||
1386178|NCT01395797|Primary|Drug's Break Point|Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug.|Following 2 weeks of Pioglitazone (PIO) maintenance.||||Mouse clicks||Standard Deviation|Mean
1386179|NCT01395784|Secondary|Analgesic Responses Using the Cold Pressor Test|Latency to withdraw hand from cold water during the cold pressor test.|Measured during the lab session conducted at the end of each maintenance period||||seconds||Standard Deviation|Mean
1386180|NCT01395784|Primary|"Subjective Ratings of Good Drug Effect"|Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)|Measured during the lab session conducted at the end of each maintenance period|Shown below are peak drug effects from each of the 3 maintenance periods (Placebo, Pioglitazone (PIO) 15, and PIO 45)|||units on a scale||Standard Deviation|Mean
1386181|NCT01395758|Secondary|ORR Among Subjects in the Crossover Period Treated With Erlotinib Plus Tivantinib|Per RECIST v1.1, CR = disappearance of all lesions and PR = at least 30% decrease in the sum of diameters of target lesions. ORR = (CR+PR)/# subjects.|Date of randomization to the date of death from any cause or to the date that the subject discontinues from the study, assessed up to 24 months.||||Participants|||Count of Participants
1386182|NCT01395758|Secondary|Objective Response Rate (ORR) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.|Per RECIST v1.1, Complete Response (CR) = disappearance of all lesions and Partial Response (PR) = at least 30% decrease in the sum of diameters of target lesions. ORR = (CR+PR)/# subjects.|Date of randomization to the date of death from any cause or to the date that the subject discontinues from the study, assessed up to 24 months||||Participants|||Count of Participants
1386183|NCT01395758|Secondary|Overall Survival (OS) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.|OS is calculated from the date of randomization until death from any cause.|Date of randomization to the date of death from any cause, assessed up to 24 months||||months||95% Confidence Interval|Median
1386184|NCT01395758|Primary|Progression-free Survival (PFS) Among Subjects With KRAS Mutation Positive NSCLC (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Single Agent Chemotherapy.|Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or progression of existing non-target lesions are also considered progression.|Date of randomization until disease progression per RECIST (v 1.1) or death from any cause, whichever came first, assessed up to 24 months.||||weeks||95% Confidence Interval|Median
1386185|NCT01395524|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Participants|||Number
1386186|NCT01395524|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Participants|||Number
1386187|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat (ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.The N denotes the number of patients with a baseline and last on-treatment value.|||units on a scale||Standard Deviation|Mean
1386188|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat(ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The N denotes the number of patients with a baseline and last on-treatment value.|||units on a scale||Standard Deviation|Mean
1386189|NCT01395524|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Participants|||Number
1386190|NCT01395394|Primary|C-Reactive Protein (CRP)|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|CRP will be measured every other hour for six hours at baseline (study visit 1) for all study groups and again during a second visit 2 weeks after baseline in BH4 Non-Responders only (study visit 2)|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. CRP was measured in 10 subjects - data were unavailable for 1 control participant due to inadequate sample volume.|||mg/dl||Standard Deviation|Mean
1386191|NCT01395394|Primary|Lipid Peroxidation|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|Lipid peroxidation will be measured every other hour for six hours at baseline (study visit 1) for all study groups|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. TBARS was measured in 3 BH4 responders only - data were unavailable for 8 other participants (2 responders, 3 non-responders, and 3 controls) due to inadequate sample volume.|||umole/L||Standard Deviation|Mean
1386192|NCT01395368|Primary|Brain Speed Test|Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.|Participants completed brain speed test on the same day as enrollment. No follow-up required.|Number of participants who completed the study with the exception of 4 subjects whose data was excluded due to the fact that they were younger than the the normative age-specific data available and BST Z-scores were not able to be calculated.|||z-score||95% Confidence Interval|Mean
1386193|NCT01395277|Secondary|Pulse Wave Velocity / Arterial Stiffness|Assessment of pulse wave velocity in the common carotid artery and the femoral artery provides an index of arterial stiffness.|Prior to (baseline) and 2 hours following beverage consumption||||cm / sec||Standard Deviation|Mean
1386194|NCT01395277|Primary|Cutaneous Blood Flow Response to Local Heating of the Skin.|Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.|prior to (baseline) and 2 hours post beverage consumption||||percent change in mean skin blood flow||Standard Deviation|Mean
1386195|NCT01395043|Primary|Postoperative Pain Using Numerical Rating Scale (NRS) 0-10|"NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain.~NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing."|0-36 hours postoperative||||Units on Numerical Rating Score||Inter-Quartile Range|Median
1386196|NCT01395043|Secondary|Opioid Requirements Postoperative|Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine.|48 hours from arriving in the post anesthesia care unit.||||mg iv morphin equivalent||95% Confidence Interval|Mean
1386197|NCT01395017|Secondary|Progression Free Survival (PFS)|PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.|Time from randomization to earliest PFS event by 02 December 2013|The ITT data which was composed of all randomized participants.|||Days||95% Confidence Interval|Median
1386198|NCT01395017|Primary|Overall Survival|Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.|From randomization until date of death from any cause by 02 December 2013|The intent-to-treat (ITT) data which was composed of all randomized participants.|||Days||95% Confidence Interval|Median
1386199|NCT01394991|Secondary|Red Blood Cell Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.|||participants|||Number
1386200|NCT01394991|Secondary|Number of Hemoglobin Responders|Hemoglobin response was defined as a hemoglobin increase of ≥2 g/dL from baseline or reaching a hemoglobin concentration of 12 g/dL, regardless of dose adjustment.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.|||participants|||Number
1386201|NCT01394991|Secondary|Mortality|Number of participants who died during the study.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1386202|NCT01394991|Secondary|Time to First Suspected Thrombovascular Event|Analysis of time to first suspected thrombovascular event (TVE) measured from the date of randomization to the date of the first suspected TVE during the study. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1386203|NCT01394991|Secondary|Number of Suspected Thrombovascular Events|Number of participants who have at least 1 suspected thrombovascular events (TVEs) during the entire study. Suspected TVEs were defined as suspected TVEs during the entire study, whether clinically relevant and objectively confirmed by the Adjudication Committee or not, whether confirmed by the investigator or not.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1386204|NCT01394991|Secondary|Time to First Positively Adjudicated Thrombovascular Event|Analysis of time to first positively adjudicated thrombovascular event (TVE) measured from the date of randomization to the date of the first clinically relevant and objectively confirmed TVE as determined by the Adjudication Committee. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1386205|NCT01394991|Secondary|Number of Positively Adjudicated Thrombovascular Events|The number of participants who have at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) during the study.|during the study (randomization through week 26)|The modified intent-to-treat (mITT) population used for safety analysis population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
1386206|NCT01394991|Primary|Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16|Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests.|from randomization through Week 16|The modified intent-to-treat (mITT) population was defined to include all randomized participants who received at least 1 dose of study drug.|||particpants|||Number
1386207|NCT01394978|Primary|Safety Endpoints|"Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome~Renal adverse events~Cardiac adverse events~Death (all causes)~Hospital readmission"|90 days|Units analyzed represents the number of adverse events that occurred among all study participants in each arm.|||Events|Events||Count of Units
1386208|NCT01394926|Secondary|Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group.|Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison , this study was stopped prematurely. No efficacy analyses were performed.||||||
1386209|NCT01394926|Primary|Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.|Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison, this study was stopped prematurely. No efficacy analyses were performed.||||||
1386210|NCT01394718|Secondary|Average Pruritus Score|Pruritus scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Pruritus scores range from 1 (none) to 3 (intolerable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo|||units on a scale||Full Range|Median
1386211|NCT01394718|Secondary|Average Nausea Score|Nausea scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Nausea Scores range from 1 (none) to 4 (severe).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo|||units on a scale||Full Range|Median
1386212|NCT01394718|Secondary|Average Pain Score|Pain Scores were monitored using the numeric pain assessment scale in both treatment arms of the study and recorded and averaged for the first 24 hours after initial intra-operative dose of study drug. The numeric pain assessment scale is a verbal self-reported pain assessment that ranges between 1 (no pain) to 10 (worst pain imaginable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo|||units on a scale||Standard Deviation|Mean
1386213|NCT01394718|Primary|Total Opiate Requirement|Total opiate requirement was monitored 24 hours post-operatively. Morphine and hydromorphone measurements were totaled and recorded in mg/kg/day of morphine equivalents.|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo.|||mg/kg||Standard Deviation|Mean
1386214|NCT01394692|Secondary|Neurological Deficit|Assessment of new postoperative deficits following tumor surgery|7 days|||||||
1386215|NCT01394692|Secondary|Volumetric Assessment|Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI|72 hours|||||||
1386216|NCT01394692|Secondary|Progression-free Survival|Progression-free survival (radiological and/or clinical progression) at 6 months following surgery|6 months|||||||
1386217|NCT01394692|Primary|Extent of Resection|Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved|72 hours|Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.|||participants|||Number
1386218|NCT01394627|Secondary|Change From Baseline in Inflammation|Change in interleukin-6|Baseline and 2 hours after hypoglycemia|We included the 17 subjects who completed each arm and had interleukin-6 data for both arms (placebo and eplerenone). We calculated the change in IL-6 as IL-6 during hypoglycemia minus IL-6 at baseline.|||pg/ml||Standard Deviation|Mean
1402527|NCT01243320|Primary|Change in Chloride Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
1386219|NCT01394627|Primary|Change From Baseline in Cardiovascular Autonomic Function|Modified oxford procedures was performed in duplicate immediately prior to start of the hypoglycemic clamp and during the last 30 min of the clamp (i.e. during the last 30 min of exposure to 2 hours of hypoglycemia).. We calculated the baroreflex sensitivity (the relationship between RR interval and change in systolic blood pressure defined as the change in the inter-beat cardiac interval in milliseconds per unit change in blood pressure in mmHg) at each time point and then the change in baroreflex sensitivity (BRS during hypoglycemia minus BRS at baseline)|Baseline and 2 hours after hypoglycemia|We included the 13 subjects who completed each arm, had usable baroreflex sensitivity data for both treatments (placebo and eplerenone), and achieved a blood sugar during hypoglycemia of less than or equal to 3.0 mmol/L for each clamp.|||ms/mmHg||Standard Deviation|Mean
1386220|NCT01394614|Primary|Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine|Incidence rates will be computed by comparing narcolepsy incidence rates in exposed and non-exposed subjects. Comparison of narcolepsy incidence rates in the period prior to vaccine administration and pseudo-vaccine administration will be used to test the comparability of exposed and non-exposed group.|Narcolepsy onset during the 16-week post-vaccination period.||||events per 100,000 person-years|||Number
1386221|NCT01394523|Primary|Post-operative Pain Score|Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.|30 minutes||||pain score||Standard Deviation|Mean
1386222|NCT01394510|Secondary|Oral Disposition Index|The change in the oral disposition index defined was the change in the early insulin response divided by the change in glucose from 0-30 minutes during the oral glucose tolerance test divided by fasting insulin.|4 weeks||||mg/dl||Standard Deviation|Mean
1386223|NCT01394510|Secondary|Area Under the Curve for Glucose (AUCg)|Change in AUCg from 0-120 minutes during the oral glucose tolerance test at 4 weeks compared to baseline|4 weeks||||mg/dl x 120 minutes||Standard Deviation|Mean
1386224|NCT01394510|Primary|Fasting Urine F2 Alpha Isoprostane Levels|Change in fasting urine isoprostane levels at 4 weeks vs baseline as a marker of oxidative stress|4 weeks|Change in urine F2 alpha isoprostanes/mg urine creatinine. Urine isoprostanes were only measured in a subset of participants due to lack of effect of the intervention on glucose tolerance.|||ng/ml||Standard Deviation|Mean
1386225|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The HAQ is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). Data allowing the evaluation of HAQ was available for 73 participants in DMARD-IR group and 157 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The “n” represents the number of participants analyzed at a specified time point.|||units on a scale||Standard Deviation|Mean
1386226|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|VAS for fatigue is a 100 mm scale for participant’s assessment of their current level of fatigue: 0 mm corresponds to “no perception of fatigue”; 100 mm is the “maximum that may be perceived”. The mean VAS fatigue scores were evaluated after the first infusion of TCZ in two different sub populations, classified according to the previous pharmacological treatment: participants with inadequate response to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of fatigue (VAS) was available for 45 participants in DMARD-IR group and 113 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."|||units on a scale||Standard Deviation|Mean
1386227|NCT01394276|Secondary|Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The DAS28 index applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints) 3. ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. The mean DAS28 scores were evaluated after the first infusion of TCZ in two different sub populations: participants with inadequate response (IR) to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of DAS28 was available for 81 participants in DMARD-IR group and 203 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."|||units on a scale||Standard Deviation|Mean
1386245|NCT01394211|Primary|Rate of pCR at Primary Site (T0) and Nodal Sites (T0N0)|Defined as no evidence of microscopic invasive tumor present. Determined by pathology. Estimated with an exact 95% confidence interval.|Six months from the initiation of neoadjuvant therapy|Participants withdrew from participation||||||
1389181|NCT01364870|Primary|Self-Reported Pain With Movement|"While subject's knee extension is measured, they report their pain on 0-20 Numeric Rating Scale (where 0 is no pain and 20 is pain as bad as you can imagine)."|1 day post-op||||scores on a scale||Full Range|Median
1386228|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.|The presence and severity of SH and JE of third MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
1386229|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand|The presence and severity of SH and JE of second MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of second MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
1386230|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of SH and JE of third MCP joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of right hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intraarticular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
1386231|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of synovial hyperplasia (SH) and joint effusion (JE) of second metacarpo-phalangeal (MCP) joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, synovial hyperplasia and joint effusion were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
1386232|NCT01394276|Secondary|Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion|Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||percentage of participants|||Number
1386233|NCT01394276|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
1386234|NCT01394276|Secondary|Percentage of Participants Discontinuing Treatment With Tocilizumab|The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||percentage of participants|||Number
1386235|NCT01394276|Secondary|Number of Participants With Concomitant Medications|Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
1386246|NCT01394185|Primary|Marijuana Self-administration - Drug Vs Money Choice|Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint|12-day Dronabinol maintenance period||||Cannabis Cigarettes Chosen||Standard Error|Mean
1386247|NCT01394185|Primary|Marijuana Self-administration - Progressive Ratio|Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint|12-day Dronabinol maintenance period||||Progressive Ratios Completed||Standard Error|Mean
1386248|NCT01394159|Secondary|Technical Failure|Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved|6 months||||participants|||Number
1386236|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab|The health assessment questionnaire (HAQ) is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, the participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score of minimum/maximum i.e., 0 (best) to 3 (worst).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of HAQ was available for 66 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.|||units on a scale||Standard Deviation|Mean
1386237|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab|VAS for fatigue is a 100 mm scale for participant’s assessment of their current level of fatigue. The ‘0 ‘mm corresponds to “no perception of fatigue,” ‘100 mm’ is the “maximum level of fatigue that may be perceived.” Mean score of VAS fatigue in participants were reported.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of fatigue based on VAS was available for 50 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.|||units on a scale||Standard Deviation|Mean
1386238|NCT01394276|Secondary|Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab|The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3.ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation.|Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease activity based on 28 joints count was available for 93 participants in TCZ group.|||units on a scale||Standard Deviation|Mean
1386239|NCT01394276|Primary|Percentage of Participants Achieving Disease Remission After 6 Months of Treatment|Disease remission is defined as a DAS28 score < 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant’s judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease remission was available for 226 participants in TCZ group.|||percentage of participants|||Number
1386240|NCT01394276|Primary|Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment|Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant’s judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of low disease activity was available for 226 participants in TCZ group.|||percentage of participants|||Number
1386241|NCT01394250|Secondary|Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The FLACC score was completed immediately after IV cannulation by a member of the clinical care team who was not part of the study. During initial trial design, the goal was to collect FLACC score pre and post cannulation; however, it was decided prior to enrollment that FLACC score would not be collected pre cannulation, only post.|Up to 5 minutes after IV Cannulation|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.|||units on a scale||95% Confidence Interval|Median
1386242|NCT01394250|Primary|Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation|The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of “no pain” (0) to “very much pain” (10).|Baseline and 30 minutes|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.|||units on a scale||95% Confidence Interval|Mean
1386243|NCT01394211|Secondary|Proportion of Patients Achieving Down-staging to a Pathologic Stage 0 or 1||Six months from the initiation of neoadjuvant therapy|Participants withdrew from participation||||||
1386251|NCT01394081|Secondary|Days Until VA Clinic Appointment|The number of days from day of randomization to day that the participant attended the VA clinic appointment (derived from the VA medical records). Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.|6 months||||days||Standard Deviation|Mean
1386252|NCT01394081|Primary|Attendance at a VA Appointment|Attendance at a VA appointment was derived from VA clinical records, defined as the participant attending a scheduled VA clinic appointment. Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.|6 months|Consenting participants who were randomized and lived in rural location.|||participants|||Number
1386253|NCT01393964|Other Pre-specified|Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Vz was measured in mL per kilogram body weight (mL/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1386254|NCT01393964|Other Pre-specified|Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. CLT was measured in mL per hour per kilogram body weight (mL/h/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1386255|NCT01393964|Other Pre-specified|Median Time to Maximal Concentration (Tmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Tmax was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||h||Full Range|Median
1386256|NCT01393964|Other Pre-specified|Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. T-Half was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||h||Standard Deviation|Mean
1386257|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN – 3.0; Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 – 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN – 11.5, Gr2:>11.5 – 12.5, Gr3: 12.5 – 13.5, Gr4: >13.5.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
1402528|NCT01243320|Primary|Change in Potassium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
1386258|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
1386259|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes absolute (abs) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils abs: Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
1386260|NCT01393964|Secondary|Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.|Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cycle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants with baseline ADA result and at least one on-treatment ADA result.|||participants|||Number
1386261|NCT01393964|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
1386262|NCT01393964|Primary|Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD participants had 2 additional sample times: immediately prior to and immediately after dialysis. AUC was measured in µg*h/mL. PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1386263|NCT01393964|Primary|Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using a validated Enzyme-linked immunoassay (ELISA). Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Cmax was measured in micrograms per milliliter (µg/mL). Pharmacokinetic (PK) parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1402529|NCT01243320|Primary|Change in Sodium Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmol/L||95% Confidence Interval|Mean
1386264|NCT01393899|Secondary|Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose|Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.|Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit|Pharmacokinetic analysis set - included all participants who received at least 1 dose of study medication and had at least 1 measurable plasma concentration. n=number of observations above lower limit of quantification.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1386265|NCT01393899|Secondary|Change From Baseline in Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Weeks 8, 12 and 26|mFAS|||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
1386266|NCT01393899|Secondary|Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline and Weeks 8, 12 and 26|mFAS|||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
1386267|NCT01393899|Secondary|Change From Baseline in CRP by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 4, 8, 12, 20 and 26|mFAS|||milligram per liter (mg/L)||Standard Deviation|Mean
1386268|NCT01393899|Secondary|C-Reactive Protein (CRP) by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS|||milligram per liter (mg/L)||Standard Deviation|Mean
1386269|NCT01393899|Secondary|Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline|Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Week 26|mFAS who were on steroids at A3921084 Baseline|||Percentage of participants||80% Confidence Interval|Number
1386270|NCT01393899|Secondary|Kaplan-Meier Estimate of the Rate of Time to Relapse|Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8 12, 20 and 26|mFAS, n=number of participants remaining at risk|||Percent Probability||80% Confidence Interval|Number
1386271|NCT01393899|Secondary|Change From Baseline in CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Weeks 4, 8, 12, 20 and 26|mFAS|||Score on a scale||Standard Deviation|Mean
1386272|NCT01393899|Secondary|CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS|||Score on a scale||Standard Deviation|Mean
1386273|NCT01393899|Secondary|Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
1386274|NCT01393899|Secondary|Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
1386275|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
1386710|NCT01390038|Primary|Device Success Rate|"A subject is a Patient Success at 24-months if:~There is NO continuous radiolucent line around the prosthesis; and~The adjusted Constant Score is > 85 (successful outcome); and~They did not have revision surgery; and~They did not have a system-related serious adverse event."|24 months||||participants|||Number
1386276|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
1386277|NCT01393899|Secondary|Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
1386278|NCT01393899|Secondary|Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12 and 20|mFAS|||Percentage of participants||80% Confidence Interval|Number
1386279|NCT01393899|Primary|Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn’s Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 26|Modified full analysis set (mFAS), defined as all randomized participants who received at least 1 dose of investigational product (ie, active or placebo study medication) in this study and who were randomized into 1 of the tofacitinib (CP-690,550) dose groups in Study A3921083.|||Percentage of participants||80% Confidence Interval|Number
1386280|NCT01393743|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of Perampanel in Subjects With Inadequately Controlled PGTC Seizures - (for Core Study)|An Adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (i.e., the subject was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect (in the child of a subject who was exposed to the study drug). In this study, treatment emergent adverse events (TEAEs) (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first treatment dose till 30 days after the last dose or up to 21 weeks for core study and 142 weeks for extension phase.|The Safety Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had at least 1 postbaseline safety assessment.|||Participants|||Number
1386281|NCT01393743|Secondary|Summary of Percent Change From Pre-Perampanel Baseline in Seizure Frequency Per 28 Days - (for Extension Phase)|Efficacy assessments included seizure counts from participant diaries. The percent change in seizure frequency was assessed during the perampanel treatment duration, with the pre-perampanel baseline being used for evaluating the change. The pre-perampanel baseline was defined as follows: 1) for all participants who had been assigned to placebo treatment in the Core Study, the pre-perampanel baseline was computed from all valid seizure diary data during the Core Study, and 2) for participants who had been assigned to perampanel in the Core Study, the pre-perampanel baseline was computed from all valid seizure diary data during the Prerandomization Phase plus the 4 weeks prior to the Prerandomization Phase of the Core Study. The perampanel treatment duration consisted of: 1) the Randomization Phase of the Core Study plus the Extension Phase for participants assigned to perampanel in the Core Study, and 2) the Extension Phase for participants assigned to placebo in the Core Study.|Weeks: 1 to 13, 14 to 26, 27 to 39, 40 to 52, 53 to 65, 66 to 78, 79 to 91, 92 to 104, 105 to 117, 118 to 130, 131 to 143, greater than or equal to 144|Full Analysis Set, which comprised all participants who were eligible to participate in the Extension Phase, received at least 1 dose of perampanel in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during the perampanel treatment duration.|||Percent change in seizure frequency||Full Range|Median
1386291|NCT01393730|Secondary|Change in Serum Androgen Levels|Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant.|Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||ng/dl||Inter-Quartile Range|Median
1386292|NCT01393730|Secondary|Presence of AR Amplification|Presence of AR amplification was measured by established methods.|Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all evaluable patients.|||Participants|||Count of Participants
1402530|NCT01243320|Secondary|Mean Change in Heart Rate|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||bpm||95% Confidence Interval|Mean
1386282|NCT01393743|Secondary|Percent Change From Core Study Prerandomization Phase in Primary Generalized Tonic-Clonic (PGTC) Seizure Frequency Per 28 Days - (for Extension Phase)|Week 1 began on the date of first dose of the perampanel treatment regardless of whether it occurred in the Core Study or Extension Phase and continued to and included the date of the last dose of perampanel in the Extension Phase. For any given analysis window and seizure type(s), a 50% responder from Core Study Randomization is a participant whose seizure frequency per 28 days for that seizure type(s) during that analysis window is 50% to 100% lower than his or her Core Study Prerandomization baseline seizure frequency per 28 days for that same seizure type(s). In Part B of the Extension Phase (after Visit 15), the seizure diary is only completed for days on which a seizure occurred and missing days were imputed as non-seizure days.|Date of first dose of study drug to date of last dose of study drug in the Extension Phase|Full analysis set included all participants who were eligible to participate in the Extension Phase, received at least 1 dose of perampanel in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during the perampanel treatment duration.|||Percent change in PGTC seizure frequency||Full Range|Median
1386283|NCT01393743|Secondary|50% Responder Rate for Primary Generalized Seizure Subtype During Maintenance Period - LOCF - (for Core Study)|Primary generalized seizure subtype included absence and myoclonic seizures. A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance - (LOCF) from prerandomization. The data was presented as the percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Only a subset of participants in the Full Analysis Set who experienced these seizure types during the Prerandomization Phase of the study were included in this analysis.|||Percentage of participants|||Number
1386284|NCT01393743|Secondary|50% Responder Rate for All Seizures During Maintenance-LOCF - (for Core Study)|All seizures included PGTC, myoclonic, absence and all other seizures that occur during the study. A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance- LOCF from prerandomization. The data was presented as percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set|||Percentage of participants|||Number
1386285|NCT01393743|Secondary|Median Percent Change in Primary Generalized Seizure Subtype Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for primary generalized seizure subtype (myoclonic and absence) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set|||Percent Change||Full Range|Median
1386286|NCT01393743|Secondary|Median Percent Change in All Seizure Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for all seizures (PGTC, myoclonic, absence and all other seizures that occur during the study) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set|||Percent Change||Full Range|Median
1386287|NCT01393743|Primary|50% Responder Rate in Primary Generalized Tonic-Clonic Seizure Frequency Per 28 Days Relative to the Core Study Prerandomization Phase – (for Extension Phase)|Responder rate was defined as the percentage of participants who experienced a 50% or greater reduction in PGTC and total seizure frequency during treatment per 28 days relative to baseline (responder). Week 1 began on the date of first dose of the perampanel treatment regardless of whether it occurred in the Core Study or Extension Phase and continued to and included the date of the last dose of perampanel in the Extension Phase. For any given analysis window and seizure type(s), a 50% response from Core Study Prerandomization is a participant whose seizure frequency per 28 days for that seizure type(s) during that analysis window is 50% to 100% lower than his or her Core Study Prerandomization baseline seizure frequency per 28 days for that same seizure type(s). In Part B of the Extension Phase (after Visit 15), the seizure diary is only completed for days on which a seizure occurred and missing days were imputed as non-seizure days.|Week 1 of perampanel treatment to date of last dose of perampanel in the Extension Phase|The Extension Phase FAS included participants who were eligible to participate in the Extension Phase, received at least 1 dose of study drug in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during study drug treatment duration.|||Percentage of participants|||Number
1386288|NCT01393743|Primary|50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance - LOCF - (for Core Study)|A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance-last observation carried forward (LOCF) from prerandomization. The data was presented as the percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set included all randomized participants who received as least 1 dose of study drug and had any postbaseline seizure frequency data. Last observation carried forward (LOCF).|||Percentage of participants|||Number
1386289|NCT01393743|Primary|Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days (as determined from participant diaries) was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change from baseline in PGTC seizure was analyzed over the Titration and Maintenance Periods combined, while baseline was defined as seizure frequency per 28 days based on all valid diary data during the Prerandomization Phase.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|The Full Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had any postbaseline seizure frequency data during the Randomization Phase.|||Percent change||Full Range|Median
1386293|NCT01393730|Secondary|Time to Progression (TTP)|TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||Months||95% Confidence Interval|Median
1386294|NCT01393730|Secondary|Best Overall Response|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1386295|NCT01393730|Secondary|Time to PSA Progression|Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response.|PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1386296|NCT01393730|Secondary|Prostate-Specific Antigen (PSA) Response|PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria.|PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1386297|NCT01393730|Secondary|Change in Serum Levels of Testosterone|Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant.|Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||ng/dL||Inter-Quartile Range|Median
1386298|NCT01393730|Primary|Number of Participants With Androgen Receptor (AR) Related Mutations|AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods.|Pairs of patients samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all patients evaluable for AR mutation.|||Participants|||Count of Participants
1386299|NCT01393717|Secondary|Overall Survival at Year Two Among AutoHCT Patients With BV|Overall Survival (OS) defined as the time from first treatment day (post AHCT) until death. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.|Assessed for up to 5 years, at least half of the surviving participants followed 2+ years|Among the 57 patients receiving BV, only 50 patients had undergone autologous transplants.|||survival probability||95% Confidence Interval|Number
1386300|NCT01393717|Secondary|Progression Free Survival at Year Two Among AutoHCT Patients With BV|Progression Free Survival (PFS) defined as the time from first treatment day (post AHCT) until objective or symptomatic relapse or death as a result of lymphoma or acute toxicity of treatment. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.|Assessed for up to 5 years, at least half of the surviving participants followed 2+ years|Among the 57 patients receiving BV, only 50 patients had undergone autologous transplants.|||survival probability||95% Confidence Interval|Number
1386301|NCT01393717|Secondary|Total CD34+ Cell Dose Among Patients Receiving Brentuximab Vedotin Followed by Autologous Hematopoietic Stem Cell Transplantation|Among the patients receiving salvage Brentuximab Vedotin (BV) followed by Autologous Hematopoietic Stem Cell Transplantation (AutoHCT), their total CD34+ cell yield by stem cell mobilization.|60 days after completion of last course of study treatment, up to conditioning regimens|Among the 57 enrolled patients, 50 patients receive BV followed by AutoHCT, 32 in Cohort #1 and 18 in Cohort #2.|||x10^6 cells/kg||Full Range|Median
1386302|NCT01393717|Primary|Complete Response (CR) Rate in Cohort #2|The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.|21 days after completion of last course of study treatment, up to 5 years|Among the 20 enrolled patients in Cohort #2, all the 20 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
1386303|NCT01393717|Primary|Overall Response Rate in Cohort #2|The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.|21 days after completion of last course of study treatment, up to 5 years|Among the 20 enrolled patients in Cohort #2, all the 20 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
1386304|NCT01393717|Primary|Complete Response (CR) Rate Among Patients With Salvage Brentuximab Vedotin (BV)|The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.|21 days after completion of last course of study treatment, up to 5 years|Among the 57 enrolled patients, only 56 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
1386305|NCT01393717|Primary|Overall Response Rate Among Patients With Salvage Brentuximab Vedotin (BV)|The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.|21 days after completion of last course of study treatment, up to 5 years|Among the 57 enrolled patients, only 56 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
1386306|NCT01393704|Secondary|Total Operation Time|Time from incision to end of surgery|5 minutes postoperatively||||minutes||Standard Deviation|Mean
1386307|NCT01393704|Secondary|Number of Participants With Peri-operative Complications|Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).|8 weeks postoperatively||||Participants|||Count of Participants
1386308|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Objective calculation of blood loss via the measurement of suction canister fluid (ml) was one of these. The calculation for estimated blood loss will be as follows: EBL = [total suction canister volume] - [volume of irrigation used] - [volume of vasopressin solution injected /2].|5 minutes post-operatively|Due to practice pattern differences among sites, there was some missing data for suction canister blood loss calculation. In these cases, total suction canister volume and/or volume of irrigation used were not measured.|||millileters||Standard Deviation|Mean
1386309|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome: Subjective surgeon's estimate of blood loss (ml) was one measurement method.|5 minutes post-operatively||||millileters||Standard Deviation|Mean
1386310|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.|5 minutes post-operatively|Due to practice pattern differences among sites, there was some missing data for the change in hematocrit variable, where the hematocrit either pre-operatively or post-operatively was not collected.|||hematocrit percentage||Standard Deviation|Mean
1386311|NCT01393626|Secondary|Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA|"EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.~Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||mm||Standard Error|Mean
1386312|NCT01393626|Secondary|EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit|EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||mm||Standard Deviation|Mean
1386313|NCT01393626|Secondary|Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA|"EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.|||Score on a Scale||Standard Error|Mean
1386389|NCT01392742|Primary|Percentage of Participants With Relapse|Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.|Up to 24 weeks after EOT (up to Week 96)|PP population.|||percentage of participants|||Number
1387064|NCT01385644|Primary|Number of Participants Who Demonstrated Acute Adverse Events Following Infusion|Acute adverse events following infusion was defined as the development of anaphalaxis and/or a 25% increase or decrease from baseline of hemodynamic measurements.|4 hours post-infusion|Data from 8 participants was analyzed. (4 from each group)|||participants|||Number
1386314|NCT01393626|Secondary|EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit|"EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from -0.594 to 1.000; a higher score indicates a better health state."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a Scale||Standard Deviation|Mean
1386315|NCT01393626|Secondary|Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA|"The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.~Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a Scale||Standard Error|Mean
1386316|NCT01393626|Secondary|Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit|The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a Scale||Standard Deviation|Mean
1386317|NCT01393626|Secondary|Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category|The IBD Patient Reported Treatment Impact Modified (PRTI) questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to re-use the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.|Week 8/ET visit|FAS. Number of Participants Analyzed is the number of participants in the analysis set.|||Percentage of Participants|||Number
1386318|NCT01393626|Secondary|Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Week 8/ET visit|FAS. Number of Participants Analyzed is the number of participants in the analysis set.|||Percentage of Participants|||Number
1386319|NCT01393626|Secondary|Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Week 8/ET visit|FAS|||Percentage of Participants|||Number
1386320|NCT01393626|Secondary|Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)|"IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL.~Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a scale||Standard Error|Mean
1386321|NCT01393626|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit|The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QOL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.|||Score on a scale||Standard Deviation|Mean
1386322|NCT01393626|Secondary|Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit|Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.|Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit|Pharmacokinetic analysis set - included all participants who received at least one dose of study medication and had at least one measurable plasma concentration. n is the number of observations (i.e. non-missing concentrations) at each timepoint.|||nanograms per milliliter||Standard Deviation|Mean
1386323|NCT01393626|Secondary|Calprotectin Fecal Concentrations at Weeks 2, 4, and 8|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.|||mg per kilogram (mg/kg)||Standard Deviation|Mean
1386324|NCT01393626|Secondary|C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.|||Milligrams per liter (mg/L)||Standard Deviation|Mean
1386325|NCT01393626|Secondary|CDAI Scores at Weeks 2, 4, and 8|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.|||Score on a scale||Standard Deviation|Mean
1386326|NCT01393626|Secondary|Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8|"Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
1386327|NCT01393626|Secondary|Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8|"Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
1386328|NCT01393626|Secondary|Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8|"Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
1386329|NCT01393626|Secondary|Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4|"Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Weeks 2 and 4|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
1386390|NCT01392742|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).|24 weeks after End of treatment (EOT) (up to Week 96)|Per Protocol (PP) population included all participants without any protocol violation.|||percentage of participants|||Number
1386330|NCT01393626|Primary|Percentage of Participants in Clinical Remission (as Defined by a Crohn’s Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8|"Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant’s diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Week 8|Full analysis set (FAS) – included all randomized participants who received at least 1 dose of investigational product and who had a qualified CDAI score calculated using the hematocrit value measured at baseline visit (Day 1). Participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
1386331|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386332|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386333|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386334|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386335|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386336|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386337|NCT01393613|Secondary|Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.|Participants discontinued for lack of efficacy during the trial were reported here.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||percentage of participants|||Number
1386338|NCT01393613|Secondary|Percentage of Participants With Response at Week 6.|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of 1 or 2.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||percentage of participants|||Number
1386339|NCT01393613|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1386340|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386341|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). The analysis of secondary endpoints was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Although only the comparison of brexpiprazole 4 mg/day vs placebo met the gatekeeping threshold in the primary analysis, statistical testing for the other doses was reported for information.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386342|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.|PSP is a validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 3 and Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386343|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.|Severity of illness for each participant was rated using the CGI-S, which was the key secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386344|NCT01393613|Primary|Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1386345|NCT01393600|Post-Hoc|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site)|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).|||units on a scale||Standard Error|Least Squares Mean
1386346|NCT01393600|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD)|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).|||units on a scale||Standard Error|Mean
1386347|NCT01393600|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).|||units on a scale||Standard Error|Least Squares Mean
1386348|NCT01393457|Secondary|Number of Participants Who Completed the 10 Week Trial||10 weeks||||participants|||Number
1386349|NCT01393457|Primary|Cocaine Use Based on Urine Drug Screening|The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.|10 weeks|intention to treat|||number of negative drug screens||Standard Deviation|Mean
1386350|NCT01393444|Secondary|Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System|Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.|||participants|||Number
1386351|NCT01393444|Primary|Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG|Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.|||participants|||Number
1386352|NCT01393405|Other Pre-specified|Calprotectin Levels < 50 mcg/g Stool in Patients in Remission at Week 48 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening|Steroid free clinical remission as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point and stool calprotectin levels of ≤ 50mcg at week 48 of the induction period in the subgroup of patients with calprotectin ≥ 250mcg/g stool at screening.|48 weeks|33/44 patient in the Methotrexate Maintenance group and 32/40 patients in the Placebo Maintenance group met the criteria of calprotectin ≥ 250 mcg/g stool at screening|||Participants|||Count of Participants
1386353|NCT01393405|Other Pre-specified|Calprotectin Levels < 50 mcg/g Stool in Patients in Remission at Week 16 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening|Steroid free clinical remission as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point and stool calprotectin levels of ≤ 50mcg at week 16 of the induction period in the subgroup of patients with calprotectin ≥ 250mcg/g stool at screening.|16 weeks|134 /179 (75%) patients had a calprotectin value ≥ 250 mcg/g stool at screening.|||Participants|||Count of Participants
1386354|NCT01393405|Other Pre-specified|Calprotectin Levels <250 mcg/g Stool in Patients in Response or in Remission at Week 48 With Calprotectin Levels > 250 mcg/g Stool at Screening|Steroid free clinical remission as defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point or steroid free clinical response defined as a reduction from baseline in the clinical Mayo score of ≥ 2 points and at least 25%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0-1 point and a clinical Mayo score ≤5 and stool calprotectin levels <250 mcg/g stool at week 32 of the maintenance period in the subgroup of patients with calprotectin ≥ 250mcg/g stool at screening.|48 weeks|33/44 patient in the Methotrexate Maintenance group and 32/40 patients in the Placebo Maintenance group met the criteria of calprotectin ≥ 250 mcg/g stool at screening|||Participants|||Count of Participants
1386355|NCT01393405|Other Pre-specified|Calprotectin Levels <250 mcg/g Stool in Patients in Response or in Remission at Week 16 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening|Steroid free clinical remission as defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point or steroid free clinical response defined as a reduction from baseline in the clinical Mayo score of ≥ 2 points and at least 25%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0-1 point and a clinical Mayo score ≤5 and stool calprotectin levels <250 mcg/g stool at week 16 of the induction period in the subgroup of patients with calprotectin >250mcg/g stool at screening.|16 weeks|134 /179 (75%) patients had a calprotectin value ≥ 250 mcg/g stool at screening.|||Participants|||Count of Participants
1386356|NCT01393405|Secondary|Relapse of Disease Between Week 17-48|Relapse of disease in the Maintenance period as defined as an increase of 3 or more points in the partial Mayo clinic score (excluding sigmoidoscopy) with an absolute clinical Mayo score ≥ 4 or need for retreatment with steroids.|48 weeks||||Participants|||Count of Participants
1386357|NCT01393405|Secondary|Mucosal Healing at Week 48.|Mucosal healing is defined as an absolute Mayo subscore for endoscopy of 0 or 1|48 weeks||||Participants|||Count of Participants
1386358|NCT01393405|Primary|Relapse Free Survival Week 17-48|Relapse-free survival: Total week 48 Mayo score not exceeding 2 points, with all individual subscores not exceeding 1 point and relapse free survival defined by a numerical stable Mayo score throughout 32 weeks of maintenance therapy without increase of 3 or more points in the partial Mayo clinic score (excluding sigmoidoscopy) compared to the partial Mayo score of the individual patient at randomization at week 16 and no steroid use or other immunosuppressive medication throughout the 32 week maintenance period.|48 weeks||||Participants|||Count of Participants
1386359|NCT01393132|Secondary|Tear Film Break up Time|"Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).~The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.~Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms)."|Days 56 (+28 day follow up)||||seconds||Standard Deviation|Mean
1386360|NCT01393132|Secondary|Ocular Discomfort Index|"Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).~(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).~The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.~For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time.~OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability."|Days 56 (+28 day follow up)||||units on a scale||Standard Deviation|Mean
1386361|NCT01393132|Secondary|Corneal Fluorescein Staining|"Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).~The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability."|Days 56 (+28 day follow up)||||units on a scale||Standard Deviation|Mean
1386362|NCT01393132|Primary|Safety|Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).|Day 1, Day 14, Day 28 and Day 56||||event|||Number
1386363|NCT01393106|Secondary|Idelalisib Trough and Peak Plasma Concentration at Week 4|Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.|Predose and 1.5 hours postdose at Week 4|Participants in the ITT Analysis Set with available data were analyzed.|||ng/mL|||Number
1386364|NCT01393106|Secondary|Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug||Up to Week 110|ITT Analysis Set|||number of doses||Standard Deviation|Mean
1386365|NCT01393106|Secondary|Overall Safety Profile of Idelalisib|"The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. Clinically significant abnormalities in ECG were as determined by the investigator."|Up to Week 110|ITT Analysis Set|||percentage of participants|||Number
1386366|NCT01393106|Secondary|Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines||Up to Week 110|This analysis was not conducted due to discrepancies with the transfer of samples.||||||
1386367|NCT01393106|Secondary|Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age|Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|Baseline and up to Week 110|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1386368|NCT01393106|Secondary|Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire|"Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline.~The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life."|Baseline and up to Week 110|FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint.|||units on a scale||Standard Deviation|Mean
1386369|NCT01393106|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.|Up to Week 110|No data are presented because time to treatment failure data were not collected.||||||
1386370|NCT01393106|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|ITT Analysis Set|||months||95% Confidence Interval|Median
1386371|NCT01393106|Secondary|Overall Survival|Overall survival was defined as the time from start of idelalisib treatment to death from any cause.|Up to Week 110|ITT Analysis Set|||months||95% Confidence Interval|Median
1386372|NCT01393106|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.|Up to Week 110|Responding Analysis Set|||months||Full Range|Median
1386373|NCT01393106|Secondary|Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)||Up to Week 110|An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples.||||||
1386374|NCT01393106|Secondary|Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically||Baseline, Week 8, Week 48, and up to Week 110|ITT Analysis Set|||percent change in SPD||Full Range|Median
1386375|NCT01393106|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|Responding Analysis Set: participants who achieved a best response of CR or PR.|||months||95% Confidence Interval|Median
1386376|NCT01393106|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator.~CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.~PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions."|Up to Week 110|Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1386377|NCT01392963|Secondary|Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)|"HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score)~Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18."|Baseline (Week 0), Week 6, and Week 18|2 patients in the placebo first group dropped out at crossover and were not included in the 18 week assessment|||units on a scale||Standard Deviation|Mean
1386378|NCT01392963|Primary|Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6|"HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score).~PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6"|baseline and week 6|Participants that completed all study visits were included in the analysis.|||units on a scale||Standard Deviation|Mean
1386379|NCT01392742|Secondary|Percentage of Participants With Virological Response|The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.|4 weeks after EOT (up to Week 76)|PP population.|||percentage of participants|||Number
1386380|NCT01392742|Secondary|Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."|||mg||Full Range|Mean
1386381|NCT01392742|Secondary|Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."|||µg||Full Range|Mean
1386382|NCT01392742|Secondary|Duration of Treatment in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."|||days||Full Range|Mean
1386383|NCT01392742|Secondary|Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response|Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Week 4 and 12|PP population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure|||predictive value|||Number
1386384|NCT01392742|Secondary|Correlation of SVR With Early Virological Response (EVR)|Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."|||correlation coefficient|||Number
1386385|NCT01392742|Secondary|Correlation of SVR With Rapid Virological Response (RVR)|Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."|||correlation coefficient|||Number
1386386|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 12|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 12|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific group."|||percentage of participants|||Number
1386387|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 4|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 4|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure and n signified evaluable participants for specific group."|||percentage of participants|||Number
1386388|NCT01392742|Primary|Percentage of Participants Who Were Non-Responders|Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.|Up to 24 weeks after EOT (up to Week 96)|PP population.|||percentage of participants|||Number
1386391|NCT01392703|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|Criteria for normal: bilirubin (0.2 to 1.3 mg/dL); lactate dehydrogenase (101 to 227 U/L); eosinophils (0.06 to 0.87*103 c/μL); erythrocytes (4.2 to 5.8*10^6 c/μL). Participants were required to fast for a minimum of 4 hours prior to the collection of specimens for clinical laboratory tests at screening and for at least 8 hours prior to collection on Day -1. Marked abnormalities were reported for the treatment regiment that participants received just prior to clinical laboratory testing.|Day -1, Screening, and Day 9 of current treatment regimen|All participants who received at least 1 dose of any study drug.|||Participants|||Number
1386392|NCT01392703|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs or Electrocardiogram (ECG) Findings|Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. ECG findings were recorded after the participant had been supine for at least 5 minutes. Clinically significant as reported by principal investigator.|Day -1, Screening, and Days 1, 5, 9 and 10 (at study discharge)|All participants who received at least 1 dose of any study drug.|||Participants|||Number
1386393|NCT01392703|Secondary|Number of Participants With at Least 1 Adverse Event (AE), With at Least 1 Treatment-related AE, Who Discontinued Due to AEs, and With at Least 1 Serious Adverse Event (SAE)|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant who has received an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is an untoward medical event that at any dose results in death, persistent or significant disability/incapacity; is life-threatening or a congenital anomaly/birth defect; or requires or prolongs hospitalization; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention.|Continually from enrollment through Day 9 and at study discharge on Day 10|All participants who received at least 1 dose of any study drug.|||Participants|||Number
1386394|NCT01392703|Secondary|Half-life of Dasatinib||Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||Hours||Standard Deviation|Mean
1386395|NCT01392703|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib|Single-dose pharmacokinetic parameters, such as Tmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||Hours||Full Range|Median
1386396|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib|Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1386397|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib|Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1386398|NCT01392703|Primary|Maximum Observed Concentration (Cmax) of Dasatinib|Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1386399|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure|To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo|Baseline to week 8|Full Analysis Set, participants with non-missing baseline and week 8 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
1386400|NCT01392677|Secondary|Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)|To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1386401|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Total Body Weight|To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1386402|NCT01392677|Secondary|Adjusted Mean Change From Baseline in FPG|To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1386403|NCT01392677|Primary|Adjusted Mean Change From Baseline in HbA1c Levels|To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 values|||Percent||95% Confidence Interval|Least Squares Mean
1386404|NCT01392625|Secondary|Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire|Measurement of Minnesota Living with Heart Failure (MLHF) Questionnaire during the 12 month follow-up period. It measures the effects of symptoms, functional limitations, and psychological distress on an individual's quality of life. The response scale for all 21 items on the MLHF is based on a 6-point. The Maximum possible scores being 126 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.|Baseline, 6 month and 12 month||||scores on a scale||Full Range|Median
1386405|NCT01392625|Secondary|Measurement of Changes in New York Heart Association (NYHA)|Measurement of New York Heart Association (NYHA) functional class during the 12 month follow-up period.|Baseline, 6 month and 12 month||||Participants|||Count of Participants
1386409|NCT01392625|Primary|Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)|Incidence of TE-SAEs is defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or any other potential late effects detected and corroborated by clinical presentation, laboratory investigations, image analysis and when necessary with biopsy from suspected target sites in the body.|One month post-catheterization||||Participants|||Count of Participants
1386410|NCT01392573|Secondary|Change in Body Weight|Observed mean change from baseline in body weight after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using LOCF.|||kg||Standard Deviation|Mean
1386411|NCT01392573|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Observed mean change from baseline in HbA1c after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1386412|NCT01392560|Primary|Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia|The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia|Baseline and 8 weeks|Per protocol set for renal (PPS_RENAL) consists of all patients who were treated with study drug and had a baseline measurement and evaluable post-dosing renal data under the clamped hyperglycemia condition for the primary endpoint.|||mL/min/1.73 m^2||Standard Error|Mean
1386413|NCT01392547|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies|Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.|||Subjects|||Number
1386414|NCT01392547|Secondary|Number of Adverse Events|Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.|||events|||Number
1386415|NCT01392547|Secondary|Number of Doses of Trial Product Given for Each Acute Bleed||Up to 6 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.|||bleeding episodes|||Number
1386416|NCT01392547|Secondary|Effective and Sustained Bleeding Control||Up to 48 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.|||bleeding episodes|||Number
1386417|NCT01392547|Primary|Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given||Within 12 hours of first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.|||bleeding episodes|||Number
1386418|NCT01392495|Secondary|Medical Resource Utilization||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.||||||
1386419|NCT01392495|Secondary|Time to Clinical Worsening (TTCW) Endpoints||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.||||||
1386420|NCT01392495|Secondary|Change From Baseline in the Six Minute Walk Distance (6MWD)||baseline, 144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.||||||
1386421|NCT01392495|Primary|Number of Patients With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the trial.|144 weeks|Safety Analysis Set: The safety analysis set included all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment.|||Participants|||Number
1386422|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Toddler dose up to 1 Month (28 to 42 days) after toddler dose|Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.|||participants|||Number
1386439|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||EU/mL||95% Confidence Interval|Geometric Mean
1386423|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).|1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose|Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.|||participants|||Number
1386424|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Baseline up to 1 Month (28 to 42 days) after infant series|Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.|||participants|||Number
1386425|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after toddler dose|Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’ =participants reporting yes for >=1 day or no for all days for specified event for each arm, respectively.|||percentage of participants|||Number
1386426|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.|Within 4 days after infant series Dose 3|Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.|||percentage of participants|||Number
1386427|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 2|Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.|||percentage of participants|||Number
1386428|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1|Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 1|Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. ‘N’(number of participants analyzed)=participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.|||percentage of participants|||Number
1386440|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mcg/mL||95% Confidence Interval|Geometric Mean
1386429|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
1386430|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
1386431|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||titer||95% Confidence Interval|Geometric Mean
1386432|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
1386433|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1386434|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||EU/mL||95% Confidence Interval|Geometric Mean
1386435|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mcg/mL||95% Confidence Interval|Geometric Mean
1386436|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||titer||95% Confidence Interval|Geometric Mean
1386437|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
1386438|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
1386508|NCT01392053|Secondary|Obstetric Outcomes - Moment of Utilization of Oxytocin|Oxytocin is a drug used to induce or enhance the muscular activity of the uterus. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed|||centimeters||Standard Deviation|Mean
1386441|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series|Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
1386442|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series|Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
1386443|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.|1 month after the toddler dose|mITT toddler immunogenicity set: eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1386444|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1386445|NCT01392378|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1386446|NCT01392326|Secondary|Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline||Week 24|Full Analysis set|||% participants|||Number
1386447|NCT01392326|Secondary|Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline||Week 24|Full analysis set|||% participants|||Number
1386448|NCT01392326|Secondary|Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)|Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.|Week 24|.Full analysis set.|||units on a scale||Standard Error|Mean
1386449|NCT01392326|Secondary|Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.|Week 24|Full analysis set|||% participant|||Number
1386509|NCT01392053|Secondary|Obstetric Outcome - Moment of Corioamniorrhexis|Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed|||centimeters||Standard Deviation|Mean
1386450|NCT01392326|Secondary|Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg|"HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities – dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week Are you able to … perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled)."|Week 24|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
1386451|NCT01392326|Secondary|Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Week 24|Full Analysis Set|||units on scale||Standard Error|Least Squares Mean
1386452|NCT01392326|Secondary|Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg|"DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 (0:no activity, 100: highest activity possible)"|Week 24|Full Analysis Set|||units on scale||Standard Error|Least Squares Mean
1386453|NCT01392326|Secondary|Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis|Week 24|Full Analysis Set|||% of participants acheiving goal|||Number
1386454|NCT01392326|Secondary|Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis|Week 24|Full Analysis Set|||% participants acheiving goal|||Number
1386455|NCT01392326|Primary|Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)|Week 24|Full analysis set|||% participant|||Number
1386456|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386457|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386458|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386459|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386460|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386461|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386462|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386463|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386464|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386465|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386466|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386467|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386468|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386469|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386470|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386471|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386472|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386473|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386474|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386475|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386476|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386477|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386478|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386479|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386510|NCT01392053|Secondary|Obstetric Outcomes - Duration of Labour|"The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design. It was defined two sets of measures dichotomizing the groups into up to 7 hours or more than 7 hours."|10 hours|All patients in both groups were analyzed|||percentage of participants|||Number
1386480|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386481|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386482|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386483|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386484|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386485|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386486|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386487|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386488|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386511|NCT01392053|Secondary|Obstetric Outcomes - Delivery|Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress.|10 hours|All patients of both groups were analyzed.|||participants|||Number
1386489|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386490|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386491|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386492|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386493|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386494|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386495|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386496|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386497|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386498|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386499|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386500|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386501|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386502|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386503|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
1386504|NCT01392300|Primary|Investigator's Global Impression of Change|This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case).|||units on a scale||Standard Error|Least Squares Mean
1386505|NCT01392300|Primary|Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern|"Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow.~The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
1386506|NCT01392170|Primary|Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)|Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).|12 months from start of treatment with PEG-IFNá-2a|Study terminated due to low accrual. No participants were evaluable for outcome.||||||
1386507|NCT01392053|Secondary|Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.|Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers. Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups. The questionnaire applied after labour intended to assess how most women felt regarding this subject.|30 minutes|All patients participatin in the study answered a satisfaction questionnaire after labour.|||participants|||Number
1386512|NCT01392053|Secondary|Pharmacological Analgesia Request According to the Cervical Dilation.|In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly. Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods.|10 hours|Of the 46 patients who where evaluated, only 1 (one) in each group didn't request pharmacological analgesia and, thus, were excluded of the analysis of this specific outcome|||centimeters||Standard Deviation|Mean
1386513|NCT01392053|Primary|Effectiveness of Massage Therapy in Pain Relief During Labor.|The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.|30 minutes|A pilot study was conducted previously to determine the size of the population needed. Using a paired sample t-test, with a power of 95% and 5% significance level, it was determined a minimum of 12 patients for Control Group and 16 patients for Massage Group|||milimeters||Standard Deviation|Mean
1386514|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 90th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
1386515|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 30th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
1386516|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 14th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
1386517|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 7th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
1386518|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at hospital discharge, an average of 3 days after mastectomy||||units on a scale||Inter-Quartile Range|Median
1386519|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed on the first postoperative day after mastectomy||||units on a scale||Inter-Quartile Range|Median
1386520|NCT01391858|Primary|Oral Opioids Consumption|Oral opioids consumption after mastectomy until hospital discharge.|Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy||||milligram (mg)||Inter-Quartile Range|Median
1386521|NCT01391858|Primary|The Postoperative Opioid Requirement After Mastectomy|IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy|Participants received PCA pump, an average of 24 hrs after mastectomy||||milligram (mg)||Inter-Quartile Range|Median
1386522|NCT01391819|Secondary|Number of Dengue Episodes Associated With Clinical Symptoms|Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue episodes|||Number
1386523|NCT01391819|Secondary|Number of Dengue Episodes With Any Temperature Interval|Temperature intervals assessed varied from hypothermia 33.5 to 36.4 degrees Celsius (°C), to normal temperature 36.5-35.9 °C and hyperthermia 37 - 39.9 °C, or were unknown.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue episodes|||Number
1386524|NCT01391819|Secondary|Dengue Infection Episodes Related Temperature|Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||°C||Standard Deviation|Mean
1386525|NCT01391819|Secondary|Number of Hospitalization Days Due to Suspected Dengue Cases|Length of hospitalization was part of the direct medical resource, associated with dengue infection.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Days||Standard Deviation|Mean
1386526|NCT01391819|Secondary|Direct Medical Resource Associated With Suspected Dengue Cases|Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Suspected dengue infection|||Number
1386527|NCT01391819|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Year 3|The analysis was performed on the Total cohort, which included all subjects enrolled in the study.|||Participants|||Count of Participants
1387151|NCT01384019|Primary|Postinfarct Remodeling|postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI|6 months|Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group.|||Number of participants with remodeling|||Number
1386528|NCT01391819|Secondary|Subjects Absenteeism Associated With Dengue Illness|The number of suspected dengue infections with subjects missing from school due to dengue infection were recorded as part of the dengue active surveillance.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Suspected dengue infection|||Number
1386529|NCT01391819|Secondary|Number of School Days Missed by Subjects|The number of school days missed by subjects due to dengue infection were recorded as part of the dengue active surveillance.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Days||Standard Deviation|Mean
1386530|NCT01391819|Secondary|Caregiver Absenteeism Associated With Subject Dengue Illness|The number of suspected dengue infections with primary caregivers missing from work was recorded as part of health economics indirect resource utilization.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Suspected dengue infection|||Number
1386531|NCT01391819|Secondary|Number of Working Days Missed of Primary Care Giver 1 and 2|The number of days off work from caregiver were recorded as part of health economics indirect resource utilization.|Up to Day 35 post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Days||Standard Deviation|Mean
1386532|NCT01391819|Secondary|Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases|Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative or seropositive, respectively.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Participants|||Count of Participants
1386533|NCT01391819|Secondary|Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases|Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative or seropositive, respectively. Analysis was done by calendar year and age strata.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Participants|||Count of Participants
1386534|NCT01391819|Secondary|Number of Dengue Infection Cases by Virus Type (DENV)|Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Participants|||Count of Participants
1386535|NCT01391819|Secondary|Number of Subjects With Laboratory Confirmed and Probable Dengue Cases|"A case of primary or secondary symptomatic dengue infection was defined as laboratory confirmed or probable symptomatic dengue case whose previous sample collected at scheduled Visits 1- 4 (Day 0- Year 3) to detect anti-dengue IgG antibodies was seronegative or seropositive, respectively.~A probable dengue case was defined as a suspected symptomatic dengue case with the following laboratory findings: -anti-dengue IgM or anti-dengue IgG positivity in at least one sample (in either blood sample 1 or 2); no evidence of viremia (negative dengue virus identification through RT-qPCR) in blood sample 1; and no evidence of anti-dengue Ig M or IgG seroconversion between blood sample 1 and blood sample 2."|From Year 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Participants|||Count of Participants
1386536|NCT01391819|Secondary|Number of Subjects With Asymptomatic Dengue Primary Infection|Asymptomatic dengue primary infection was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits, without suspicion of dengue.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Participants|||Count of Participants
1386537|NCT01391819|Secondary|Number of Subjects With Immunoglobulin Type G (IgG) Antibodies Against Dengue|Immune response against dengue was assessed via Enzyme-linked Immunosorbent Assay (ELISA).|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Participants|||Count of Participants
1386538|NCT01391819|Primary|Number of Laboratory Confirmed Symptomatic Dengue Cases|Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.|At Year 3 (2014)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases|||Number
1386566|NCT01391507|Secondary|Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9|The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).|Baseline and Month 9|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.|||Percentage of blood pumped out||Standard Deviation|Mean
1386539|NCT01391819|Primary|Number of Laboratory Confirmed Symptomatic Dengue Virus Cases|Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.|At Year 2 (2013)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases|||Number
1386540|NCT01391819|Primary|Number of Laboratory Confirmed Symptomatic Dengue Infection Cases|Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling.|At Year 1 (2012)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases|||Number
1386541|NCT01391663|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter|CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants|||L/hr||Standard Deviation|Mean
1386542|NCT01391663|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter|Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants|||hr||Standard Deviation|Mean
1386543|NCT01391663|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.|Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.|Day 1-4, Day 10.|Healthy Korean Participants|||ng·hr/mL||Standard Deviation|Mean
1386544|NCT01391663|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter|Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants|||ng·hr/mL||Standard Deviation|Mean
1386545|NCT01391663|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10.|Healthy Korean Participants|||hr||Full Range|Median
1386546|NCT01391663|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter|Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10|Healthy Korean Participants|||ng/mL||Standard Deviation|Mean
1386547|NCT01391611|Secondary|Response Per Choi Criteria|"Response per Choi criteria~Complete response - Disappearance of all lesions; no new lesion~Partial response - A decrease in size of > or = 10% or a decrease in tumor density (HU) > or = 15% on CT. No new lesions. No obvious progression of nonmeasurable disease.~Stable disease - Does not meet the criteria for CR, PR, or PD. No symptomatic deterioration attributed to tumor progression.~Progressive disease - An increase in tumor size of > or = 10% and does not meet criteria of PR by tumor density (HU) on CT. New lesions. New intratumoral nodules or increase in the size of the existing intratumoral nodules."|6 months|Choi criteria measurements were not done due to technical difficulties.||||||
1386548|NCT01391611|Primary|Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)|"4-mo non-progression rate~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|24 weeks||||months||95% Confidence Interval|Median
1386549|NCT01391559|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication|FEV1|2 hours||||mL||Standard Deviation|Mean
1386550|NCT01391546|Secondary|Percentage of Participants Who Report at Least 1 Serious Adverse Event|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE within 35 days of vaccination were recorded."|up to 35 days after vaccination||||Percentage of Participants|||Number
1386551|NCT01391546|Secondary|Percentage of Participants Who Report at Least 1 Systemic Adverse Event|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.|up to Day 28 after vaccination|All vaccinated participants who had follow-up safety data.|||Percentage of Participants||95% Confidence Interval|Number
1386552|NCT01391546|Secondary|Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction|Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.|up to 28 days after vaccination|All vaccinated participants who had follow-up safety data.|||Percentage of Participants||95% Confidence Interval|Number
1386553|NCT01391546|Secondary|Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies|Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.|Pre-vaccination (Day 0) and 4 week post-vaccination|All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid pre- and post-vaccination data for endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
1386554|NCT01391546|Secondary|Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies|Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC)|4 week post-vaccination|All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid post-vaccination data for endpoint.|||ELISPOT count/10^6 PBMC||95% Confidence Interval|Geometric Mean
1386555|NCT01391546|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route|Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination|Pre-vaccination (Day 0) and 4 week post-vaccination|All randomised participants who had received the study vaccine via SC route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
1386556|NCT01391546|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route|Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination|Pre-vaccination (Day 0) and 4 week post-vaccination|All randomised participants who had received the study vaccine via IM route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
1386557|NCT01391546|Primary|Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination|Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).|4 week post-vaccination|All randomised participants who had received the study vaccine, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1386558|NCT01391507|Secondary|Number of Participants With Holter Electrocardiography (ECG) Parameters|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.|||Participants|||Number
1386559|NCT01391507|Secondary|Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.|||Beats per minute||Standard Deviation|Mean
1386560|NCT01391507|Secondary|Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6|Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant’s perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1386561|NCT01391507|Secondary|Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression|Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants).|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Participants|||Number
1386562|NCT01391507|Secondary|Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6|A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.|||Meter||Standard Deviation|Mean
1386563|NCT01391507|Secondary|Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6|Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Centimeter (cm)/ Second (sec)||Standard Deviation|Mean
1386564|NCT01391507|Secondary|Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6|Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. No participants were evaluable for arms COR-1 80 mg and COR-1 160 mg.|||Centimeter (cm)||Standard Deviation|Mean
1386565|NCT01391507|Secondary|Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6|The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.|||Picogram (pg)/ Milliliter (mL)||Standard Deviation|Mean
1386567|NCT01391507|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6|The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).|Baseline and Month 6|Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment. Missing data was imputed using last observation carried forward (LOCF) method.|||Percentage of blood pumped out||Standard Deviation|Mean
1386568|NCT01391468|Post-Hoc|Change of Serum IL-10 Level at 6 Months|IL-10 is an anti-inflammatory cytokine; The change of serum IL-10 level at 6 months was measured|6 months||||pg/ml||Standard Deviation|Mean
1386569|NCT01391468|Post-Hoc|Change of Serum Endotoxin Level at 6 Months|endotoxin is a marker of inflammation in chronic kidney disease patients|6 months follow-up||||EU/ml||Standard Deviation|Mean
1386570|NCT01391468|Secondary|Change of Gastrointestinal Symptoms at 6 Months|The change in gastrointestinal symptom rating scale (min and maximum scores 0-45) after treatment. The total score is reported. The higher scale represents a worse outcome.|6 months follow-up||||units on a scale||Standard Deviation|Mean
1386571|NCT01391468|Primary|the Occurrence of Cardiovascular Event and Peritonitis Events||6 month follow-up||||participants|||Number
1386572|NCT01391325|Secondary|Mean Change From Baseline to Month 6 in SF-36 PCS+MCS|The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.|Month 6|Subjects who recieved at least one dose of allopurinol|||units on a scale||Standard Deviation|Mean
1386573|NCT01391325|Secondary|Incidence of Gout Flares|Proportion of subjects who experienced at least one gout flare requiring treatment during the study.|Every month for 6 months.|Subjects who received at least one dose of allopurinol|||percentage of subjects||95% Confidence Interval|Number
1386574|NCT01391325|Secondary|Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL|Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.|Month 6|All subjects who received at least one dose of allopurinol|||percentage of subjects||95% Confidence Interval|Number
1386575|NCT01391325|Primary|Safety of Allopurinol|Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.|Every month for 6 months.|All subjects who received at least one dose of allopurinol|||percentage of subjects|||Number
1386576|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60|The Investigator rated the subject’s severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 60|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.|||Percentage of participants|||Number
1386577|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30|The Investigator rated the subject’s severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.|||Percentage of participants|||Number
1386578|NCT01391312|Primary|Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30|Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.|||Percentage of participants|||Number
1386579|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest|Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.|||Percentage of participants|||Number
1386580|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest|The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.|||Percentage of participants|||Number
1386581|NCT01391299|Secondary|Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines|Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.|Day 30|Includes participants from the Intent-to-treat Population (all randomized participants) with a rating of very unsatisfied, unsatisfied or neutral in the Subject's Assessment of Satisfaction of Appearance at baseline.|||Percentage of participants|||Number
1386582|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1386583|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1386584|NCT01391286|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||Units on a scale||Full Range|Median
1386585|NCT01391286|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||mm^2||Full Range|Median
1386586|NCT01391286|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||mm||Full Range|Median
1386587|NCT01391286|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
1386588|NCT01391273|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||Units on a scale||Standard Deviation|Mean
1386589|NCT01391273|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||mm^2||Standard Deviation|Mean
1386590|NCT01391273|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent to treat population included all randomized participants.|||mm||Standard Deviation|Mean
1386591|NCT01391273|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
1386592|NCT01391013|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||CD4 cells||Inter-Quartile Range|Median
1386593|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of ‘0’ and a standard deviation of ‘1’. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Z score||Inter-Quartile Range|Median
1386594|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||T score||Inter-Quartile Range|Median
1386595|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of ‘0’ and a standard deviation of ‘1’. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Z score||Inter-Quartile Range|Median
1386649|NCT01390818|Secondary|Apparent Terminal Half-Life (t1/2) of SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hour||Full Range|Median
1386596|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||T score||Inter-Quartile Range|Median
1386597|NCT01391013|Secondary|Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)|Visceral fat content in abdomen will be analyzed with median change in VAT by an abdomen Computerized Tomography.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||cm square||Inter-Quartile Range|Median
1386598|NCT01391013|Secondary|Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)|Leg fat content will be analyzed by Dual Energy X-ray Absortiometry (DEXA scan).|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Percentage of fat||Inter-Quartile Range|Median
1386599|NCT01391013|Secondary|Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score|The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of a participant. It is calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, and systolic blood pressure. The framingham risk score is calculated as: for males: 0 point (1 percentage) up to 17 points (30 percentages); whereas for females: 0 to 9 points (1 percentage) up to 25 points (30 percentage). Higher scores indicate high cardiovascular risk.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Framingham risk score||Inter-Quartile Range|Median
1386600|NCT01391013|Secondary|Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The Homeostatic Model Assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. HOMA-IR is reflected in the diminished effect of insulin on hepatic glucose production. HOMA-IR is calculated as: (Glucose [mg/dL] X Insulin [pmol/L]) / (405 X 6.945). Higher scores indicate worse insulin resistance.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||HOMA score||Inter-Quartile Range|Median
1386601|NCT01391013|Secondary|Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||mg/dL||Inter-Quartile Range|Median
1386602|NCT01391013|Secondary|Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||mg/dL||Inter-Quartile Range|Median
1386603|NCT01391013|Secondary|Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL||Baseline (Day1 of Week 1), Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||mg/dL||Inter-Quartile Range|Median
1386604|NCT01391013|Secondary|Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Endothelial cells||Full Range|Median
1386605|NCT01391013|Secondary|Change From Baseline to Week 48 in Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Endothelial cells||Full Range|Median
1386606|NCT01391013|Secondary|Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Participants|||Number
1386607|NCT01391013|Secondary|Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Percentage of brachial artery diameter||Inter-Quartile Range|Median
1386608|NCT01391013|Primary|Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline (Day 1 of Week 1) to Week 24|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Percentage of brachial artery diameter||Inter-Quartile Range|Median
1386609|NCT01391000|Secondary|Short Form 12-PCS for Quality of Life Assessment|The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. SF-12 score measures substantially limited physical disability, general well-being and the perception of one's state of health, (Physical Component Summary) and also measure the psychological attitude of the patient, the limitation in social and personal activities (Mental Component Summary). Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)||||units on a scale||95% Confidence Interval|Mean
1386610|NCT01391000|Secondary|Constant Murley Score for Range of Motion and Shoulder Function Assessment.|The Constant Murley scale had values from 0 to 100 where zero represented the worst possible range of motion and shoulder function and 100 the best.|Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)||||units on a scale||95% Confidence Interval|Mean
1386611|NCT01391000|Primary|Visual Analogue Scale Mean Score|To evaluate the analgesic efficacy of Light Amplification by Stimulated Emission of Radiation carbon dioxide therapy vs Transcutaneous Electrical Nerve Stimulator during the first cycle of rehabilitation through Visual Analogue Scale, calculating the mean score in values of beginning and end of daily treatment. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.|Change from baseline in pain at the end of the rehabilitation cycle (two weeks)||||units on a scale||95% Confidence Interval|Mean
1386612|NCT01390948|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Safety population included all participants that received study drug.|||percentage of participants|||Number
1386613|NCT01390948|Secondary|Number of Dose Administrations of Study Treatment in the Concurrent Phase|Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks.|Beginning of the concurrent phase to end of treatment break (10 weeks)|Safety population included all participants that received study drug.|||number of dose administrations||Full Range|Median
1386614|NCT01390948|Secondary|Percentage of Participants With a Treatment Delay or Discontinuation||From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants|||Number
1386615|NCT01390948|Secondary|Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations||From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Safety population included all participants that received study treatment.|||percentage of participants|||Number
1386616|NCT01390948|Secondary|Neurological Psychological Function as Measured by the Wechsler Scale|The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability.|End of treatment (approximately 58 weeks post-baseline)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||units on a scale||Standard Deviation|Mean
1386617|NCT01390948|Secondary|Health Status as Measured by the Health Utility Index (HUI)|HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older.|Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up)|Randomized participant population aged 5 years or older with a measure at the specified time point. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
1386618|NCT01390948|Secondary|Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival|Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants|||Number
1386619|NCT01390948|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions >/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: ≥ 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population with a measurable lesion at baseline.|||percentage of participants||95% Confidence Interval|Number
1386620|NCT01390948|Secondary|EFS as Assessed by the Investigator|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|From the time of randomization to the date of any defined event (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||months||95% Confidence Interval|Median
1386691|NCT01390415|Primary|Number of Participants With Macroalbuminuria After 6 Months of Treatment|Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.|Baseline and Month 6||||participants|||Number
1386621|NCT01390948|Secondary|Percentage of Participants With EFS as Determined by the CRRC at 1 Year|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|1 year|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants||95% Confidence Interval|Number
1386622|NCT01390948|Secondary|Percentage of Participants With EFS as Determined by the CRRC at 6 Months|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|6 months|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants||95% Confidence Interval|Number
1386623|NCT01390948|Secondary|Percentage of Participants With 1-Year Survival|1-year survival was estimated using the Kaplan-Meier method.|1 year|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants||95% Confidence Interval|Number
1386624|NCT01390948|Secondary|Overall Survival|Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method.|From the time of randomization to the date of death (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||months||95% Confidence Interval|Median
1386625|NCT01390948|Primary|Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC)|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-high-grade glioma (HGG) malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or a greater than or equal to (>/=) 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|From the time of randomization to the date of any defined event (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||months||95% Confidence Interval|Median
1386626|NCT01390909|Primary|Average Annualized Costs|Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.|1 year|For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.|||United States dollars||Standard Deviation|Mean
1386627|NCT01390870|Primary|Number of Participants Reporting Compliance With Medication|"Compliance was calculated based on the participant's response to the following question: In general, how many times did you miss taking your prostate medication? Responses were measured on a 5-point scale. Participants who answered I never miss a dose of my medication were considered compliant. All other responses were considered non-compliant."|Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)|All enrolled participants taking 5-alpha reductase inhibitors and/or alpha blockers|||participants|||Number
1386628|NCT01390857|Secondary|Number of Participants Classified as Effective and Not Effective|"The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. “Improved” was regarded as “Effective,” and “Unchanged” and ” Worsen” were regarded as “Not effective. The two participants classifed as “Not effective” were classified as “Unchanged.”"|1 month|Efficacy Analysis Set: all participants assessed for efficacy who completed all study visits; 7 participants did not undergo an efficacy evaluation, and 13 participants failed to visit after the first visit.|||participants|||Number
1386629|NCT01390857|Secondary|Number of Participants With Any Unexpected Adverse Drug Reactions|An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.|1 month|ITT Safety Population|||participants|||Number
1386630|NCT01390857|Secondary|Number of Participants With the Indicated Adverse Drug Reactions|"An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|1 month|ITT Safety Population|||participants|||Number
1386631|NCT01390857|Primary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|1 month|Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants.|||participants|||Number
1386632|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in India|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
1386633|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in Korea and Taiwan|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.|||Percentage of Participants|||Number
1386634|NCT01390844|Secondary|Percentage of Participants With an AE of Anemia in India|Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
1386635|NCT01390844|Secondary|Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan|Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|All Participants as Treated (APaT) - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.|||Percentage of Participants|||Number
1386636|NCT01390844|Secondary|Percentage of Participants in India Achieving EVR at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
1386637|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).|||Percentage of Participants|||Number
1386638|NCT01390844|Secondary|Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm); participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
1386639|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm).|||Percentage of Participants|||Number
1386640|NCT01390844|Primary|Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
1386641|NCT01390844|Primary|Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population|SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).|||Percentage of Participants|||Number
1386642|NCT01390818|Secondary|Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)|CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From the date of randomisation every 6 weeks up to assessed up to 4 years|The Efficacy Analysis Set (EEF) included all subjects who received at least 1 trial treatment dose (Pimasertib or SAR245409) and had radiographic baseline and at least one evaluable post baseline tumor assessment.|||subjects|||Number
1386643|NCT01390818|Secondary|pERK Concentrations in PBMCs|"pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily, Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily, Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily and Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily reporting arms."|DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)|Biomarker Analysis Set for pharmacodynamics marker analysis in PBMC included all subjects who received at least first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here “N” signifies number of subject analysed for this outcome measure” and “n” signifies number of subject analysed at specific time point.|||fluorescence intensity||Standard Deviation|Mean
1386644|NCT01390818|Secondary|pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)|"pS6 Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily, Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily, Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily and Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily reporting arms."|DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)|The Biomarker Analysis Set for pharmacodynamics (PD) marker analysis in PBMC included all subjects who received at least the first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here “n” signifies the number of subjects evaluable at the specific time points.|||fluorescence intensity||Standard Deviation|Mean
1386645|NCT01390818|Secondary|Accumulation Ratio (Racc) for Cmax of SAR245409: Day 15|Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax divided by Day 1 Cmax.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of participant analyzed for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||Ratio||95% Confidence Interval|Geometric Mean
1386646|NCT01390818|Secondary|Accumulation Ratio (Racc) for AUCtau of SAR245409: Day 15|Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau divided by Day 1 dosing interval AUCtau.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of participant analyzed for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||ratio||95% Confidence Interval|Geometric Mean
1386647|NCT01390818|Secondary|Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||litre||95% Confidence Interval|Geometric Mean
1386648|NCT01390818|Secondary|Total Body Clearance (CL/f) of SAR245409|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||litre per hour||95% Confidence Interval|Geometric Mean
1386650|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (0-inf) of SAR245409: Day 1|"Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.~Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale."|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1386651|NCT01390818|Secondary|Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1386652|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409|Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour*nanogram per milliliter (hr*ng/mL).|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1386653|NCT01390818|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409|The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hours||Full Range|Median
1386654|NCT01390818|Secondary|Maximum Observed Plasma Concentration (Cmax) for SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||nanogram per millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
1386655|NCT01390818|Secondary|Accumulation Ratio (Racc) for Cmax of Pimasertib (MSC1936369B): Day 15|Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax/Day 1 Cmax.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||ratio||95% Confidence Interval|Geometric Mean
1386656|NCT01390818|Secondary|Accumulation Ratio (Racc) for AUCtau of Pimasertib (MSC1936369B): Day 15|Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau per Day 1 dosing interval AUCtau.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||ratio||95% Confidence Interval|Geometric Mean
1386657|NCT01390818|Secondary|Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at specific time points."|||liter||95% Confidence Interval|Geometric Mean
1386658|NCT01390818|Secondary|Total Body Clearance (CL/f) of Pimasertib (MSC1936369B)|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||litre per hour (L/hr)||95% Confidence Interval|Geometric Mean
1386659|NCT01390818|Secondary|Half-Life (t1/2) of MSC1936369B (Pimasertib)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hour||Full Range|Median
1386660|NCT01390818|Secondary|Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1386661|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1|"Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.~Terminal rate constant (λz)."|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts|"The PK analysis set. Here N signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf."|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1386662|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)|Area under the concentration-time curve from time 0 to the last quantifiable concentration.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set . Here n signifies the number of subjects evaluable at the specific time points."|||hour*nanogram per millilitre (hr*ng/mL)||95% Confidence Interval|Geometric Mean
1386663|NCT01390818|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here n signifies the number of subjects evaluable at the specific time points."|||hour||Full Range|Median
1386664|NCT01390818|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The pharmacokinetic (PK) analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||nanogram/millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
1386665|NCT01390818|Secondary|Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.|Baseline up to 30 Days after last dose; assessed up to 4 years|The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.|||subjects|||Number
1386666|NCT01390818|Primary|Number of Subjects With Dose Limiting Toxicities (DLT)|DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of > 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption > 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.|Day 1 up to Day 16 in cycle 1|The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug.|||subjects|||Number
1386667|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.|in selected 30-second SENSIMED Triggerfish recording intervals during sleep|One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.|||% of accurate recording intervals||95% Confidence Interval|Number
1386668|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|"Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep.~One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording."|from 1 hour before sleep to 1 hour after sleep|Subjects were included in this analysis if the difference in IOP from wake to sleep was at least 3 mmHg, as determined using pneumatonometry on the eye contralateral to that of SENSIMED Triggerfish, and if the SENSIMED Triggerfish recording contained at least 80% of the expected data points.|||mV/h||Standard Deviation|Mean
1386706|NCT01390038|Secondary|Device Parameters|"Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:~Migration~Osteolysis~Subsidence"|24 months||||Percentage of participants|||Number
1386669|NCT01390649|Secondary|Responder Rate|The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to ≥ 50 x 10^9/L after the first IgPro10 administration).|Within 6 days after the first infusion|Full analysis set: all subjects who received at least 1 IgPro10 infusion.|||percentage of participants||95% Confidence Interval|Number
1386670|NCT01390649|Primary|Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis|The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.|Within 3 days of infusion|||||||
1386671|NCT01390441|Primary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation in the Extension Study|Serum ADA positivity is determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 56, Week 68, Week 80, Week 82, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.||||||
1386672|NCT01390441|Primary|Number of Participants With Immunoglobulin G (IgG) Response in the Extension Study|Serum IgG levels are determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 68, Week 80, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.||||||
1386673|NCT01390441|Other Pre-specified|Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point|The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP.|Baseline, Week 6, Week 12|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.|||Score||Standard Deviation|Mean
1386674|NCT01390441|Other Pre-specified|Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.|||Participants|||Number
1386675|NCT01390441|Other Pre-specified|Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|Full Analysis Set defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.|||Participants|||Number
1386676|NCT01390441|Secondary|Part B: Cmax After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment.|Day 15|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.||||||
1386677|NCT01390441|Secondary|Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3.|Day 15|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15); had no major protocol violations; had a complete PK profile; had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course.|||ng/mL||95% Confidence Interval|Geometric Mean
1386678|NCT01390441|Primary|Number of Participants Who Discontinued Study Drug Due to Adverse Events|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks|APaT population defined as all participants who received at least one dose of study drug.|||Participants|||Number
1386679|NCT01390441|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks|All Participants as Treated (APaT) population defined as all participants who received at least one dose of study drug.|||Participants|||Number
1386680|NCT01390441|Primary|Part B: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.||||||
1386681|NCT01390441|Primary|Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15), had no major protocol violations, had a complete pharmacokinetic (PK) profile, had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course|||hr*mg/mL||95% Confidence Interval|Geometric Mean
1386682|NCT01390428|Primary|Apparent Terminal Half-life (t1/2) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr.||Geometric Coefficient of Variation|Geometric Mean
1386683|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10|Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 10 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
1386684|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Mild HI, Moderate HI and Healthy Matched to Mild HI or Moderate HI are absent because they had a different Measure Type and Method of Dispersion|||nM||Full Range|Median
1386685|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Severe HI and Matched Healthy to Severe HI are absent because they had a different Measure Type and Method of Dispersion|||nM||95% Confidence Interval|Geometric Mean
1386686|NCT01390428|Primary|Time to Peak Concentration (Tmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr.||Full Range|Median
1386687|NCT01390428|Primary|Maximum Concentration (Cmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM||95% Confidence Interval|Geometric Mean
1386688|NCT01390428|Primary|Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||95% Confidence Interval|Geometric Mean
1386689|NCT01390415|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 6.|Baseline and Month 6||||mmHg||Standard Deviation|Mean
1386690|NCT01390415|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 6.|Baseline and Month 6||||mmHg||Standard Deviation|Mean
1386692|NCT01390402|Primary|Number of Participants With Molecular Complete Remission at 3 Month Post Transplant|Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.|Baseline to up to 4 months post-transplant||||participants|||Number
1386693|NCT01390389|Secondary|To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.|Changes in Phosphocreatine and beta NTP (represented as adenosine triphosphate) in gray matter and white matter will be determined by measurements at Week 0 and Week 4 in Geri BD group challenged with CoQ10 and in healthy controls.|4-week trial|Healthy controls with no evidence of current or past psychiatric disorders, and subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in the CoQ10 group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.|||Integration Expressed as Arbitrary Unit||Standard Error|Least Squares Mean
1386694|NCT01390389|Primary|Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline|Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.|Baseline||||Integration Expressed as Arbitrary Unit||Standard Error|Mean
1386695|NCT01390259|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|22 hours||||mg/dL||Standard Error|Mean
1386696|NCT01390259|Secondary|Percent Time in Euglycemia|Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl|22 hours||||percentage of time in range||Standard Error|Mean
1386697|NCT01390259|Primary|Hypoglycemic Events|"Number of hypoglycemic events below 70 mg/dL per patient per day~Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms"|22 hours||||events/patient||Standard Error|Mean
1386698|NCT01390246|Primary|Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)|The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer’s recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.|End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation||||Participants|||Count of Participants
1386699|NCT01390246|Primary|Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)|The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer’s recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.|Visit 6 (end of 12 weeks of medication therapy)||||Participants|||Count of Participants
1386700|NCT01390246|Primary|Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date|Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject’s symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.|Quit date, visit 2 (one week after starting the 12-week course of therapy)||||MNWS Score||Standard Deviation|Mean
1386701|NCT01390246|Primary|Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment|Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject’s symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.|During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)||||MNWS Score||Standard Deviation|Mean
1386702|NCT01390233|Primary|Vaginal Delivery|The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.|Gestational age 26-42 weeks||||participants|||Number
1386703|NCT01390181|Primary|Inflammatory Markers Levels|Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), & Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.|Baseline and 12 months|No participants were analyzed because the study terminated prior to data collection for final primary outcome measure.||||||
1386704|NCT01390038|Secondary|Pain: Visual Analog Scale|0 (best) - 10 (worst)|24 Months||||units on a scale||Standard Deviation|Mean
1386705|NCT01390038|Secondary|American Shoulder and Elbow Surgeon Score|0 (worst) - 100 (best)|24 Months||||units on a scale||Standard Deviation|Mean
1386711|NCT01389973|Secondary|Part 1: Percent Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, and Bilirubin Concentration at Week 28||Baseline and Week 28|"Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial). N (number of participants analyzed) signifies participants who were evalubale for this outcome measure. n signifies participants who were evalubale for each specified category."|||percent change||Standard Deviation|Mean
1386712|NCT01389973|Secondary|Part 1: Percent Change From Baseline in ALP Concentration at Week 28||Baseline and Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||percent change||Standard Deviation|Mean
1386713|NCT01389973|Secondary|Part 1: Number of Participants With ALP Remission at Week 28|ALP remission is defined as either normalization of ALP (for participants with baseline ALP between 1.67*and 2.8* upper limit of normal [ULN] or an ALP less than [˂]1.67*ULN [for participants with baseline ALP greater than {˃} 2.8* ULN]). ALP levels above 1.67* ULN level were associated with an increased rate of disease progression.|Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||participants|||Number
1386714|NCT01389973|Secondary|Part 1: Number of Participants With ALP Response at Week 28||Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||participants|||Number
1386715|NCT01389973|Primary|Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12|The ALP response was defined as a greater than 40 percent (%) decrease from Baseline in ALP concentration at Week 12.|Week 12|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||participants|||Number
1386716|NCT01389882|Secondary|Capillary Blood HCO3|Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mmol/L||Standard Deviation|Mean
1386717|NCT01389882|Secondary|Capillary Blood pO2|Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mmHg||Standard Deviation|Mean
1386718|NCT01389882|Secondary|Capillary Blood pCO2|Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mmHg||Standard Deviation|Mean
1386719|NCT01389882|Secondary|Capillary Blood pH|Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||pH||Standard Deviation|Mean
1386720|NCT01389882|Secondary|Fraction of Oxygen|Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode|four hours||||percentage of concentration||Full Range|Median
1386721|NCT01389882|Secondary|Peak EAdi|Peak electrical activity of the diaphragm|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||uV||Standard Deviation|Mean
1386722|NCT01389882|Secondary|Work of Breathing|Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mJ/L||Full Range|Median
1386723|NCT01389882|Secondary|Dynamic Compliance|Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mL/cmH2O||Standard Deviation|Mean
1386724|NCT01389882|Secondary|Expiratory Tidal Volume|Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mL/Kg||Standard Deviation|Mean
1386725|NCT01389882|Secondary|Minute Ventilation|Minute ventilation measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||L/min/Kg||Standard Deviation|Mean
1386726|NCT01389882|Secondary|Mean Airway Pressure|mean airway pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||cmH2O||Standard Deviation|Mean
1386727|NCT01389882|Primary|Peak Inspiratory Pressure|peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||cmH2O||Standard Deviation|Mean
1386728|NCT01389856|Secondary|Accumulation Index (AI) for Bosentan|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Days 1 and 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AI was calculated as the ratio AUCtau /AUC0-12 for the subjects having PK samples collected on Day 1 and Day 5 and with AUC0-12 > 0 ng.h/mL.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||accumulation index||95% Confidence Interval|Geometric Mean
1386737|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386785|NCT01389284|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent|24 hours postdose or immediately before the first intake of rescue medication|Intent-to-treat (ITT)|||Participants|||Number
1386729|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 5 (AUC0-24C Day 5) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 5 was calculated as a multiple of AUCtau, (2 × AUCtau for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1386730|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 1 (AUC0-24C Day 1) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 1 was calculated as a multiple of AUC0-12, (2 × AUC0-12 for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1386731|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Dosing Interval at Steady State on Day 5 (AUCtau) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUCtau Day 5 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1386732|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 12 h (AUC0-12 Day 1)) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-12 Day 1 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1386733|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386734|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386735|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386736|NCT01389856|Secondary|Tmax for Bosentan on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386751|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 48 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|48 hours|Randomized and treated patients with available data|||oxygenation index||95% Confidence Interval|Median
1386738|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386739|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386740|NCT01389856|Secondary|Time to Maximum Whole Blood Concentration (Tmax) for Bosentan on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
1386741|NCT01389856|Secondary|Cmax for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Cmax obtained directly from the measured concentrations . Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||ng/mL||95% Confidence Interval|Geometric Mean
1386742|NCT01389856|Secondary|Maximum Whole Blood Concentration (Cmax) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Cmax was obtained directly from the measured concentrations. Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|up to 12 hours|Pharmacokinetic (PK) analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||ng/mL||95% Confidence Interval|Geometric Mean
1386743|NCT01389856|Secondary|Change in Fraction of Inspired Oxygen (FiO2) From Baseline to 72 Hours Following Study Drug Administration|FiO2 was determined according to each study centers’ standard procedure at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage of oxygen||95% Confidence Interval|Median
1386744|NCT01389856|Secondary|Change in Post-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage saturation||95% Confidence Interval|Median
1386745|NCT01389856|Secondary|Change in Pre-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage saturation||95% Confidence Interval|Median
1386746|NCT01389856|Secondary|Change in Partial Pressure of Carbon Dioxide (PaCO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaCO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||mm Hg||95% Confidence Interval|Median
1386747|NCT01389856|Secondary|Change in Partial Pressure of Oxygen (PaO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||mm Hg||95% Confidence Interval|Median
1386748|NCT01389856|Secondary|Change in Arterial Blood Oxygen Saturation (SaO2) From Baseline to 72 Hours Following Study Drug Administration|SaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage saturation||95% Confidence Interval|Median
1386749|NCT01389856|Secondary|Change in Arterial Blood Gas (ABG) pH From Baseline to 72 Hours Following Study Drug Administration|pH was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||pH||95% Confidence Interval|Median
1386750|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 72 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|72 hours|Randomized and treated patients with available data|||oxygenation index||95% Confidence Interval|Median
1386752|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 24 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|24 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
1386753|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 12 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|12 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
1386754|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 5 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|5 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
1386755|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 3 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|3 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
1386756|NCT01389856|Secondary|Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment|"The presence of PH was assessed by echocardiography. PH was reported as ‘present’ if at least one of the following criteria was met:~Shunt through ductus arteriosus was either ‘predominant right to left’ or ‘bidirectional’~Shunt through foramen ovale was either ‘predominant right to left’ or ‘bidirectional’~Marked right ventricular dilation was ticked ‘present’~Paradoxical shift of intraventricular septum was ticked ‘present’~Right ventricular systolic pressure (mmHg) was > 2/3 of the reported systemic blood pressure"|From baseline to up to 14 days|Randomized and treated patients|||percentage of participants|||Number
1386757|NCT01389856|Secondary|Percentage of Patients Requiring Re-initiation of iNO Therapy|Re-initiation of iNO therapy following weaning from iNO therapy|From baseline to up to 21 days|Randomized and treated patients|||percentage of participants|||Number
1386758|NCT01389856|Primary|Time to Complete Weaning From Mechanical Ventilation|Calculated from the time from first study drug administration to complete weaning from mechanical ventilation|From baseline to up to 21 days|Randomized and treated patients|||days||95% Confidence Interval|Median
1386759|NCT01389856|Primary|Time to Complete Weaning From iNO|Calculated from the time from first study drug administration to complete weaning from iNO. Weaning from iNO was considered complete if there was no requirement for the re-initiation of iNO within 24 h after stopping|From baseline to up to 21 days|Randomized and treated patients|||days||95% Confidence Interval|Median
1386760|NCT01389856|Primary|Percentage of Patients With Treatment Failure|Treatment failure was defined as the need for extra corporeal membrane oxygenation or initiation of alternative pulmonary vasodilator treatment|From baseline to up to 21 days|Randomized and treated patients|||percentage of participants|||Number
1386761|NCT01389817|Primary|N95 Peak Via pERG and fERG -PhNR|The primary comparison will be a paired comparison of pre- and post-treatment retinal ganglion cell N95 pattern electroretinogram (pERG) peaks and fERG - Photopic Negative Response (PhNR). Pairing will be done between a subject's treatment and control eye.|12 months|All participants were withdrawn before any data could be obtained.||||||
1386762|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13|Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
1386763|NCT01389596|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia’s formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett’s correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
1386764|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations|Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
1386765|NCT01389596|Other Pre-specified|Number of Participants With Vital Signs Abnormalities|Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
1386766|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN).|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
1386767|NCT01389596|Other Pre-specified|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks|CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press “Yes” response key, otherwise “no”. There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.|Baseline (pre-dose at Day 1), Week 12|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||log10 milliseconds||Standard Deviation|Mean
1386768|NCT01389596|Other Pre-specified|Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task|CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.|Baseline (pre-dose at Day 1), Week 12|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||log10 milliseconds||Standard Deviation|Mean
1386769|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||T scores||Standard Deviation|Mean
1386770|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||T scores||Standard Deviation|Mean
1386786|NCT01389284|Secondary|Number of Times the Participants Took Rescue Medication Over the 24-hour Period||24 hours postdose|Intent-to-treat (ITT)|||Rescue medication intakes||Standard Deviation|Mean
1386771|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant’s behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study.|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||T scores||Standard Deviation|Mean
1386772|NCT01389596|Other Pre-specified|Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period|C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of “Yes” on “actual attempt”) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (“Yes” on “preparatory acts or behavior”)(C-CASA code 3); suicidal ideation (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of “yes”) to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported|Day 1 up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
1386773|NCT01389596|Other Pre-specified|Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline|The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of “Yes” on “actual attempt”) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (“Yes” on “preparatory acts or behavior”)(C-CASA code 3); suicidal ideation (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of “yes”) to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported.|Baseline (4 week prior to Day 1 of treatment)|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
1386774|NCT01389596|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant’s usual function b) moderate: AEs interferes to some extent with participant’s usual function c) severe: AEs interferes significantly with participant’s usual function.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.|||events|||Number
1386775|NCT01389596|Other Pre-specified|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
1386776|NCT01389596|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
1386787|NCT01389284|Secondary|Cumulative Percentage of Participants Who Took Rescue Medication||At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)|||Percentage of participants|||Number
1386777|NCT01389596|Secondary|Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase|Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {–} number of missing diary days in treatment phase])*28.|Day 1 up to Week 12|ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.|||percentage of participants|||Number
1386778|NCT01389596|Primary|Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase|"All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {–} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)."|Day 1 up to Week 12|"ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||Seizures per 28 days||Standard Error|Least Squares Mean
1386779|NCT01389596|Primary|Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase|"All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {–} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)."|Baseline phase (up to 8 weeks prior to treatment phase [Day 1])|Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.|||Seizures per 28 days||Standard Deviation|Mean
1386780|NCT01389323|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died|An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.|From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])|"All treated participants for TP and all follow-up participants for FUP. Here, n signifies the number of participants evaluable in their respective study periods."|||participants|||Number
1386781|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.|||percentage of participants||95% Confidence Interval|Number
1386782|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels <LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.|||percentage of participants||95% Confidence Interval|Number
1386783|NCT01389323|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category.|||percentage of participants||95% Confidence Interval|Number
1386784|NCT01389323|Primary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts.|||percentage of participants||95% Confidence Interval|Number
1386788|NCT01389284|Secondary|Median Time to First Intake of Rescue Medication|Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group.|Up to 24 hours postdose|Intent-to-treat (ITT)|||Hours||Full Range|Median
1386789|NCT01389284|Secondary|Pain Relief From Initial Dose|Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief|At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||Standard Deviation|Mean
1386790|NCT01389284|Secondary|Pain Intensity Differences (PIDs) by Time From Initial Dose|Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe|At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||95% Confidence Interval|Mean
1386791|NCT01389284|Secondary|Summed, Time-weighted Total Pain Relief Scores (TOTPARs)|TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24.|0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||95% Confidence Interval|Mean
1386792|NCT01389284|Secondary|Summed, Time-weighted Pain Intensity Differences (SPID)|Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||95% Confidence Interval|Mean
1386793|NCT01389284|Primary|Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)|SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|From 0 to 24 hours post-dose|Intent-to-treat (ITT)|||Score on the scale||Standard Error|Mean
1386794|NCT01389102|Primary|Mean Change the Severity of Moderate to Severe Vasomotor Symptoms|"Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.~Mild, moderate and severe were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3."|baseline to week 12 (12 weeks)||||Scores on a scale||Standard Deviation|Mean
1386795|NCT01389102|Primary|Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day|"Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day.~Mild, moderate and severe hot flushes and sweating were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity"|baseline to week 12||||Vasomotor symptoms per day||Standard Deviation|Mean
1386796|NCT01389076|Secondary|Number of Participants That Experienced SAEs During Treatment.||Up to week 13||||participants|||Number
1386797|NCT01389076|Secondary|Median Progression Free Survival (PFS) Time|The median time patients survived without progression.|2 Years|Due to the withdrawal of Bexxar by the manufacture and failure to find another supplier, the trial was abandoned and follow-up scans were not obtained. Therefore only survival is known. Progression information is not available.||||||
1386798|NCT01389076|Secondary|The Percentage of Participants Alive at 2 Years|Overall survival was examined at 2 years|2 years||||percentage of participants|||Number
1386799|NCT01389076|Secondary|Percentage of Participants That Respond to Treatment|"The overall response rate (PR [partial response] + CR [complete response]) was determined.~Partial response is defined as the regression of measurable disease with no new sites of disease.~Complete response is defined as the disappearance of all evidence of disease."|2 years||||percentage of participants||95% Confidence Interval|Number
1386800|NCT01389076|Primary|Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment|The percentage of patients that experience early onset HAMA conversion following treatment. Early-onset HAMA is defined as antimouse antibody levels (in blood serum) of at least 5 times the level of detection, occurring at or prior to the 7th week of I-131 tositumomab therapy.|7 weeks||||percentage of participants||95% Confidence Interval|Number
1386801|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively|three months|Below the number of patients with pain three months postoperatively. For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.|||Number of participants|||Number
1386802|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively|one month postoperatively|Below the number of patients with pain one month postoperatively For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.|||number of participants|||Number
1386821|NCT01388920|Primary|Change From Baseline in Lean Body Mass at 6 Months|The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan|6 months|The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.||||||
1386803|NCT01388946|Secondary|Pain Scores During Cough 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient in this group presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 48 h postoperatively|||mm||Standard Deviation|Mean
1386804|NCT01388946|Secondary|Pain Scores During Cough 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) 8 h postoperatively|||mm||Standard Deviation|Mean
1386805|NCT01388946|Secondary|Pain Scores During Cough 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 4 h postoperatively|||mm||Standard Deviation|Mean
1386806|NCT01388946|Secondary|Pain Scores During Cough 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 2 h postoperatively|||mm||Standard Deviation|Mean
1386807|NCT01388946|Secondary|Pain Scores During Cough in the PACU|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|PACU|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough in PACU|||mm||Standard Deviation|Mean
1386808|NCT01388946|Secondary|Pain Scores at Rest 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|50 patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. 1 patient in this group presented ileus after the first 24 h assessment, remaining 49 patients for assessment at 48 hours postoperatively Below are the VAS values (mean and standard deviation) at rest 48 hours postoperatively|||mm||Standard Deviation|Mean
1386809|NCT01388946|Secondary|Pain Scores at Rest 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 24 h postoperatively|||mm||Standard Deviation|Mean
1386810|NCT01388946|Secondary|Pain Scores at Rest 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 8 h postoperatively|||mm||Standard Deviation|Mean
1386811|NCT01388946|Secondary|Pain Scores at Rest 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 4 h postoperatively|||mm||Standard Deviation|Mean
1386812|NCT01388946|Secondary|Pain Scores at Rest 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h postoperatively|"Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery.~Below are the VAS values (mean and standard deviation) 2 h postoperatively at rest"|||mm||Standard Deviation|Mean
1386813|NCT01388946|Secondary|Pain Scores in the Postoperative Care Unit (PACU) at Rest|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|in PACU|Below is the mean and standard deviation of the VAS scores in PACU at rest Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery|||mm||Standard Deviation|Mean
1386814|NCT01388946|Primary|VAS Score Changes ( Cough) During 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24 h|Fifty patients in the Ropivacaine group were analyzed for the primary (VAS score at cough) and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery|||mm||Standard Deviation|Mean
1386815|NCT01388920|Secondary|Plasma Glucose|Changes from baseline in fasting blood glucose|6 months|||||||
1386816|NCT01388920|Secondary|COPD Exacerbations|Frequency and severity of COPD exacerbations|6 months|||||||
1386817|NCT01388920|Secondary|Adverse Events|Number and percentage of subjects with adverse events|6 months|||||||
1386818|NCT01388920|Secondary|Change From Baseline in Patient-reported Outcomes at 6 Months||6 months|||||||
1386819|NCT01388920|Secondary|Change From Baseline in Peripheral Muscle Strength at 6 Months||6 months|||||||
1386820|NCT01388920|Secondary|Change From Baseline in Exercise Capacity at 6 Months||6 months|||||||
1386822|NCT01388907|Secondary|mAFS Abdominopelvic Adhesion Score|mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome).|10 to 20 weeks post surgery||||units on a scale||Standard Deviation|Mean
1386823|NCT01388907|Secondary|Adnexal Adhesions|Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980’s by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome).|10 to 20 weeks post surgery||||units on a scale||Standard Deviation|Mean
1386824|NCT01388907|Secondary|Fertility|Fertility was assessed by pregnancy and deliveries rates at 3 years.|3 years||||participants|||Number
1386825|NCT01388907|Primary|Number of Patients With Adhesions to Uterine Scars|"The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy.~This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand."|10 to 20 weeks post surgery|Two patients in group Prevadh group were withdrawn from the study, at 1 and 6 days post-myomectomy. One patient was re-operated for compress removal in Prevadh group and was excluded. Two patients in group Lactate Ringer group were withdrawn from the study, at 1 and 6 days post-myomectomy.|||participants|||Number
1386826|NCT01388816|Secondary|Changes in Other Lipids and Apolipoproteins|Change from baseline (LOCF, ITT population)|28 days|ITT with LOCF|||percentage change from baseline||95% Confidence Interval|Least Squares Mean
1386827|NCT01388816|Secondary|Changes in CETP Inhibition in Plasma|Percent change from baseline in CETP Inhibition|28 days|ITT with LOCF|||percentage from baseline||95% Confidence Interval|Least Squares Mean
1386828|NCT01388816|Secondary|To Evaluate Trough Levels of DRL-17822 in Plasma|Trough levels of DRL-17822 in plasma after 28 days of treatment|28 days||||ng/mL||Standard Deviation|Mean
1386829|NCT01388816|Secondary|Changes in Vital Signs Including Blood Pressure|Vital sign abnormalities reported as treatment-emergent AEs|28 days|ITT/Safety Population|||participants|||Number
1386830|NCT01388816|Secondary|Safety and Tolerability of DRL-17822|Incidence of treatment-related adverse events|28 days|Safety/ITT Population|||participants|||Number
1386831|NCT01388816|Primary|Percent Change in HDL-C From Baseline|Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia|28 days|Intention to treat (ITT) analysis with last observation carried forward (LOCF) for missing data.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1386832|NCT01388790|Secondary|Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment.|Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1386833|NCT01388790|Primary|Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 [RECIST v 1.0] criteria).|Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1386834|NCT01388777|Primary|Rate of Complete Tumor Ablation|The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.|From cryoablation through 30 days from surgery||||Participants|||Count of Participants
1386835|NCT01388647|Other Pre-specified|Dose Limiting Toxicity (DLT)|DLT is defined as grade 4 thrombocytopenia; grade 4 anemia; grade 4 neutropenia lasting > 5 days; or any grade 3 or 4 non-hematologic toxicity occurring during Cycle 1 which is attributable to eribulin, carboplatin, trastuzumab or the combination, or the inability to deliver all three agents at the assigned dose and scheduled time during Cycle 1.The following events are excluded from the DLT definition: grade 3 nausea and/or vomiting responsive to antiemetics; grade 3 fever or infection; grade 3 diarrhea responsive to antidiarrheal therapy.|Approximately 22 days from study treatment start, per subject||||participants|||Number
1386836|NCT01388647|Other Pre-specified|Maximum Tolerated Dose (MTD) of Eribulin in Combination With Carboplatin and Trastuzuamb|The MTD is defined as the dose at which <= 1 of 6 subjects experience DLT (Dose Limiting Toxicity) and above which >= 2 of 6 subjects experience DLT.|Approximately 22 days from study treatment start, per subject|The MTD of ECH as neoadjuvant therapy for HER2+ breast cancer was determined per protocol definitions; however, due to the combination of increased hematologic toxicity and possible reduced efficacy, Phase II of this trial was not initiated.|||mg/m^2|||Number
1386837|NCT01388647|Secondary|Clinical Response|Clinical assessment of response will be performed 3 weeks after completion of study treatment. The treating physician will assess clinical response using physical examination and radiologic evaluation. Clinical response options are complete response (no invasive tumor in breast and lymph nodes), partial response (> 50% reduction in longest diameter of pretreatment tumor), no response (< 50% response to 10% growth of tumor as determined by longest diameter of pretreatment tumor size), and progression.|Assessed prior to definitive surgery, approximately 18 weeks from study treatment start.||||percentage of participants||95% Confidence Interval|Number
1386838|NCT01388647|Primary|Pathologic Response|Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).|Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start||||percentage of participants||95% Confidence Interval|Number
1386839|NCT01388530|Secondary|Attention Network Task - Incongruent Reaction Time|"Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network.~Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who completed 4 weeks of treatment, but comparison is based on Week 8 vs. baseline.|||milliseconds (ms).||Standard Deviation|Mean
1386840|NCT01388530|Secondary|Conners Global Index - Parent|"A standard, parent completed measure of ADHD symptoms.~Scale range from 0 (best) to 27 (worst).~Unit of Measure - units on a scale.~Outcome value reflects change from baseline at endpoint (Week 8)."|Baseline and Week 8.|Participants with data at baseline and week 4. We required 4 weeks treatment to include in analysis, but analysis is based on comparison of baseline and week 8.|||units on a scale||Standard Deviation|Mean
1386841|NCT01388530|Secondary|Clinical Global Impression - Improvement (CGI-I)|"A global measure of clinical improvement compared with baseline.~A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse).~Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others."|Week 8|Participants with data at baseline and week 4. As with the ADHD-RS, we included participants with at least 4 weeks of treatment, but outcome was assessed at Visit 8 compared with baseline.|||percentage of improved|||Number
1386842|NCT01388530|Primary|ADHD-IV Rating Scale (ADHD-RS)|"A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms.~Scale ranges from 0 (best) to 54 (worst).~Unit of Measure - units on a scale.~Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who participated in 4 weeks of treatment, but change comparison is baseline vs. week 8.|||units on a scale||Standard Deviation|Mean
1386843|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin|Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||nmol/L||Standard Error|Least Squares Mean
1386844|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)|Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||mIU/L||Standard Error|Least Squares Mean
1386845|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol|Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||nmol/L||Standard Error|Least Squares Mean
1386846|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin|Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||mg/L||Standard Error|Least Squares Mean
1386847|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||ratio||Standard Error|Least Squares Mean
1386878|NCT01387672|Secondary|Headache|"Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from 0 to 10. A vertical line marked at 0 means no headache (score recorded = 0), a vertical line marked at 10 means a terrible headache (score recorded = 10)."|Run-in phase - 2 days|The mean headache score considering all subjects in each of the treatment/formulation group was calculated.|||score on a scale||Standard Deviation|Mean
1386848|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||ratio||Standard Error|Least Squares Mean
1386849|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII|Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
1386850|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII|Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
1386851|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity|Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
1386852|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin|Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
1386853|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity|The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
1386854|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen|The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal 50% to 147%||Standard Error|Least Squares Mean
1386855|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer|Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||mcg/L||Standard Error|Least Squares Mean
1386879|NCT01387672|Primary|Bone Turnover Markers|"Markers of Bone Formation:~Serum Procollagen type 1 amino- terminal propeptide (P1NP)~Serum Osteocalcin (OC)~Serum Bone-specific alkaline phosphatase (BALP)~Markers of Bone Resorption:~- Serum C-telopeptides of collagen cross-links (CTX)"|3 months|One subject from the Treatment Arm 3 had outlier bone turnover markers values and was excluded from the analysis. Total number of subjects analyzed in Treatment Arm 3 was therefore 32.|||Percent change from baseline||Standard Deviation|Mean
1386856|NCT01388491|Primary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels|Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per-protocol (PP) population. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||pmol/L||Standard Error|Least Squares Mean
1386857|NCT01388361|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL).|Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator|||events|||Number
1386858|NCT01388361|Secondary|Change From Baseline in Body Weight|Corresponds to the values of change in body weight in kilograms from baseline to week 26.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period and missing data was imputed using LOCF. At baseline, the body weight values were missing for 1 subject in IDeg + Liraglutide arm from FAS and 3 subjects in NAS for IDeg arm.|||kg||Standard Deviation|Mean
1386859|NCT01388361|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Values for change in FPG in mmol/L from baseline to week 26 of randomised period.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period. The FPG values were missing for 7 subjects in FAS (2 subjects with IDeg+ liraglutide; 5 subjects with IDeg+IAsp arm) and 10 subjects in NAS for IDeg arm at baseline. The missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1386860|NCT01388361|Primary|Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)|Values for change in HbA1c from baseline to 26 weeks of treatment period.|week 0, week 26|The FAS and NAS included all randomised and non-randomised subjects respectively, and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1386861|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence.|12 months and baseline|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.|||units on a scale||Standard Deviation|Mean
1386862|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months.|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence.|6 months and 12 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months.|||units on a scale||Standard Deviation|Mean
1386863|NCT01388166|Primary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|Baseline and 6 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.|||units on a scale||Standard Deviation|Mean
1386864|NCT01387789|Secondary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1386865|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|Participants with available data at this time point|||centimeters||Standard Deviation|Mean
1386866|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1386867|NCT01387789|Secondary|Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
1386868|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|Participants with available data at this time point|||centimeters||Standard Deviation|Mean
1386869|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
1386870|NCT01387789|Primary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months|The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 “worst”-100 “best”). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1386871|NCT01387789|Primary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months||||centimeters||Standard Deviation|Mean
1386872|NCT01387789|Primary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1386873|NCT01387737|Secondary|Change in Blood Pressure||Week 52|||||||
1386874|NCT01387737|Secondary|Change in Body Weight||Week 52|||||||
1386875|NCT01387737|Secondary|Change in Fasting Plasma Glucose||Week 52|||||||
1386876|NCT01387737|Secondary|Change in HbA1c||Week 52|||||||
1386877|NCT01387737|Primary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events||54 weeks||||percentage of incidences|||Number
1387224|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Month 12|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.||||||
1386880|NCT01387607|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity|A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function.|Baseline to Follow up (Day 105)|The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.|||Events|||Number
1386881|NCT01387607|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs.|Baseline to Follow up (Day 105)|The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1386882|NCT01387607|Secondary|Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score|The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386883|NCT01387607|Secondary|Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score|The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386884|NCT01387607|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14|The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 “no pain” to 100 “worst possible pain”.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386885|NCT01387607|Secondary|Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score|The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386886|NCT01387607|Secondary|Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score|The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386887|NCT01387607|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14|The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant’s level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386888|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1387019|NCT01386632|Primary|Percentage of Participants Who Experienced Adverse Events During Treatment.|Percentage of Participants Who Experienced Adverse Events During Treatment including but are not limited to mucositis, leucopenia, neuropathy, and treatment breaks. This will be done according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0|Adverse events (AE) will be assessed from the time the subject begins the study until the 30-days after receiving the last dose of the study medication.||||percentage of patients||95% Confidence Interval|Number
1386889|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Minutes||Standard Error|Least Squares Mean
1386890|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Awakenings||Standard Error|Least Squares Mean
1386891|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Minutes||Standard Error|Least Squares Mean
1386892|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Minutes||Standard Error|Least Squares Mean
1386893|NCT01387607|Secondary|Change From Baseline in Mean Sleep Interference Score at Week 14|The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes [unable to sleep due to pain]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1386894|NCT01387607|Secondary|Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
1386895|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386896|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386927|NCT01387269|Primary|Change in Handgrip Strength|Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
1386897|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386898|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386899|NCT01387607|Secondary|Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14|Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
1386900|NCT01387607|Secondary|Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14|Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
1386901|NCT01387607|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14|The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
1386902|NCT01387607|Secondary|Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14|The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.|Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Percentage of participants|||Number
1386903|NCT01387607|Primary|Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14|Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1386904|NCT01387594|Secondary|Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity|Injection site reaction AEs include: injection site irritation, injection site pain, injection site rash, contusion, and erythema.|Baseline till End of Study/Early Withdrawal, up to Week 12|All participants who received at least one dose of study drug.|||participants|||Number
1386905|NCT01387594|Secondary|Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659|Serum samples were analysed for presence of ADAs to PF-00547659. Participants who showed positive results for PF-00547659 were reported.|Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal|All participants who received at least one dose of study drug.|||participants|||Number
1387020|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.|The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).|Week 6|PK population|||ng*h/mL||Standard Deviation|Mean
1386906|NCT01387594|Secondary|Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent for this measure are events between first dose of study drug and up to 85 days (Week 12) after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and non-serious AEs.|Baseline up to Week 12|All participants who received at least one dose of study drug were analyzed for AEs/safety. Combined data for both cohorts is presented.|||participants|||Number
1386907|NCT01387594|Primary|Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3|The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.|Baseline, Month 3|All Cohort 2 participants who were enrolled, had 2 evaluable lumbar punctures, and who received all 3 doses of study drug.|||percent change||Full Range|Median
1386908|NCT01387594|Primary|Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF)|The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.|Baseline|All Cohort 2 participants who were enrolled, had 2 evaluable LPs, and who received all 3 doses of study drug.|||cells per milliliter (cells/mL)||Full Range|Median
1386909|NCT01387581|Primary|Specificity|"Dermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called Negative."|Within 120 days of Data Lock||||percent of true negatives||95% Confidence Interval|Mean
1386910|NCT01387581|Primary|Sensitivity|"Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called Positive."|Within 120 days of Data Lock||||percent of true positives||95% Confidence Interval|Mean
1386911|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1386912|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 6|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1386913|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2|The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 2|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1386914|NCT01387542|Primary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening ."|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
1386915|NCT01387464|Primary|Mean Aqueous Humor Bromfenac Concentration||Approximately 3 hours post last dose|Per-Protocol Population|||ng/mL||Standard Deviation|Mean
1386916|NCT01387347|Secondary|Number of Adverse Events as a Measure of Safety and Tolerability|The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.|Throughout the study till Day 29|Intention to treat (ITT)|||Events|||Number
1387021|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.|The Tmax for plasma concentration.|Week 6|PK population|||h||Standard Deviation|Mean
1402531|NCT01243320|Secondary|Mean Change in Diastolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmhg||95% Confidence Interval|Mean
1386917|NCT01387347|Primary|Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye.|"Dry eye causes ocular discomfort, which is measured using a validated 4-point ORA Scale from the start of the dosing till the end of treatment (Day 29). 0 = no discomfort to 4 = constant discomfort.~If the measurement is lower, then improvement of ocular discomfort can be inferred. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29.~Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes had were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat (ITT)|||Units on a Scale||Standard Deviation|Mean
1386918|NCT01387347|Primary|Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye|"This is a test that uses orange dye (fluorescein) and a blue light to detect ocular surface defects associated with dry eye. If the test result is normal, the dye remains in the tear film on the surface of the eye and does not adhere to the eye itself. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. The scale used to determine the difference in corneal fluorescein staining between RGN-259 and placebo is the ORA scale: 0= no staining (no detectable ocular defect)to 4= confluent staining( severe ocular defect).~Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat population|||units on a scale||Standard Deviation|Mean
1386919|NCT01387282|Secondary|Change in Body Weight|Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.|Change in Body Weight from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
1386920|NCT01387282|Secondary|Change in FACIT-F Fatigue Domain Score|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best)."|Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
1386921|NCT01387282|Secondary|Change in A/CS Domain Score|"The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
1386922|NCT01387282|Primary|Change in Handgrip Strength|Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
1386923|NCT01387282|Primary|Change in Lean Body Mass|Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Lean Body Mass from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
1386924|NCT01387269|Secondary|Change in Body Weight|Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.|Change in Body Weight from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
1386925|NCT01387269|Secondary|Change in FACIT-F Fatigue Domain Score|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best)."|Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
1386926|NCT01387269|Secondary|Change in A/CS Domain Score|"The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
1386928|NCT01387269|Primary|Change in Lean Body Mass|Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Lean Body Mass from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
1386929|NCT01387230|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours Post-dose at Days 1 and 84 (Week 12)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 measurements of interest for Day 1 were collected at 1, 3, 6, 23 and 24 hours post-dose on Day 1 and for Day 84, the measures were pre-dose (24 hours post-dose of Day 83 morning dose but prior to Day 84’s dose) and 1, 3, 6, 23 and 24 hours post dose on Day 84. Baseline is the mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis performed separately by Visit/Day using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, time, time by Baseline and time by treatment interactions.|Baseline, Day 1 and Day 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
1386930|NCT01387230|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Days 1, 28 (Week 4) and 84 (Week 12)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, and Day 84 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 1 hour, 3 hours, and 6 hours. Change from Baseline was the WM minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Days 1, 28 and 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
1386931|NCT01387230|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56, 84, and 85. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 84). Change from Baseline was calculated as the trough FEV1 minus the Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all randomized par. who received >=1 dose of study drug. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1386932|NCT01387178|Secondary|Number of COPD-related Healthcare Encounters||1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007|||number of encounters|||Number
1386933|NCT01387178|Primary|Mean Number of COPD Exacerbations|Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.|1 year|The total population including participants with index dates between January 1,2004 and June 30, 2008.|||number of exacerbations||Standard Deviation|Mean
1386934|NCT01387178|Primary|Post-index Period COPD-related, Unadjusted Costs|The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.|1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007|||United States (US) dollars||Standard Deviation|Mean
1386935|NCT01387139|Secondary|Nurse Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour||||units on a scale||Inter-Quartile Range|Median
1386936|NCT01387139|Secondary|Physician Performing Procedure Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour||||units on a scale||Inter-Quartile Range|Median
1386937|NCT01387139|Secondary|Parent Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour||||units on a scale (1-10)||Inter-Quartile Range|Median
1387022|NCT01386606|Secondary|Change in Follicle Stimulating Hormone (FSH)|Changes in morning FSH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.|||mIU/mL||Standard Deviation|Mean
1387023|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.|The Cmax for plasma concentration.|Week 6|PK population|||ng/mL||Standard Deviation|Mean
1386938|NCT01387139|Secondary|Efficacy of Sedation|"Efficacy is defined as:~The patient does not have unpleasant recall of the procedure.~The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation~The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.~The procedure was successful"|After procedure is completed, on average less than 1 hour||||participants|||Number
1386939|NCT01387139|Secondary|Recovery Time|Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.|Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour||||minutes||Inter-Quartile Range|Median
1386940|NCT01387139|Primary|Frequency of Adverse Events|We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.|From enrollment through completion of follow-up, up to 7 days|Adverse events|||participants|||Number
1386941|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
1386942|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
1386943|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
1386944|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
1386945|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
1386966|NCT01386684|Secondary|Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.|"Participants were asked Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?; if Yes, was the change Initiation of new mediation/Change in Dose/Frequency or Discontinuation of medication. The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented."|Months 3, 6, 12, 18, 24, 30, and 36|The number of participants with changes in current prostate cancer treatment since the last visit at given time point.|||percentage of participants|||Number
1386946|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
1386947|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
1386948|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
1386949|NCT01387022|Secondary|Genital Viral Shedding (Viral Load on Tear Flow)||3 years|Data were not collected for this Outcome Measure||||||
1386950|NCT01387022|Secondary|Cellular and Humoral Immune Responses|We will assess whether exposure to tenofovir gel at the time of HIV acquisition alters the subsequent humoral and cellular immune responses following antiretroviral treatment initiation|3 years|Data were not collected for this Outcome Measure||||||
1386951|NCT01387022|Secondary|Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables||From randomisation until either time of termination or time of death|All participants who randomised and initiated on ART|||Participants|||Count of Participants
1386952|NCT01387022|Secondary|Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations||From randomisation until either time of termination or time of death|Resistance testing was only done on participants who were failing first line antiretroviral therapy.|||Participants|||Count of Participants
1386953|NCT01387022|Secondary|Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation|Difference between 12 months and randomisation CD4+ count was calculated and then summarised|Measured at 12 months post ART initiation|All participants for whom CD4+ count measurements were recorded at randomisation and at 12 months|||cells/uL||Inter-Quartile Range|Median
1386954|NCT01387022|Primary|The Antiretroviral Treatment Failure Rate at 12 Months.|Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death|12 months post ART intiation or until time of death|All participants who randomised and initiated on ART|||participants|||Number
1386955|NCT01386983|Secondary|Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month|EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.|3 months prior to and 12 months following index date|Enrolled Population|||dollars||95% Confidence Interval|Mean
1386956|NCT01386983|Primary|Number of Participants With Clinical Progression|Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.|3 months prior to and 12 months following index date|Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID.|||participants|||Number
1386967|NCT01386684|Secondary|Treatment Compliance|Treatment compliance by participants was assessed as the number of missed injections since the last visit.|Months 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||missed injections||Standard Deviation|Mean
1387018|NCT01386632|Secondary|Two-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.|"Outcome of tumor change will be compared in two separate ways. First, change in measured tumor size at 8 weeks and 3 months will be compared using standard linear models methods (using appropriate transformation to reduce statistical skew).~Progression was determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions."|Year 2||||percentage of patients||95% Confidence Interval|Number
1386957|NCT01386944|Secondary|Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study|Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians’ discretion.|From Baseline up to 28 days|The Analysis Population refers to the Eligibility Completer Set (ECS). The ECS is a subset of the Completer Set excluding patients with Parkinson’s disease and/or treated Polyneuropathy as concomitant disease identified by the preferred term (PT) of the MedDRA coding and patients treated with Neupro up to 4 weeks before Visit 1.|||participants|||Number
1386958|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1."|From Baseline up to 13 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
1386959|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1."|From Baseline up to 10 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
1386960|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
1386961|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1."|From Baseline up to 4 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
1386962|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1."|From Baseline up to 28 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
1386963|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
1386964|NCT01386788|Primary|Serum Cyanide Levels||blood sampling within 2 hours after smoke inhalation|All recruited patients that met all inclusion criteria including blood sampling for cyanide serum level|||participants|||Number
1386965|NCT01386788|Primary|Overall Survival After 24 Hours|Number of participants who survived at 24 hours after smoke inhalation were reported.|24 hours||||participants|||Number
1387011|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm.||Completion of Treatment|||||||
1387012|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||5 year|||||||
1386968|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for transportation costs and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
1386969|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for health care or extra help at home and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
1386970|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for medical devices and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
1386971|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for payments for medical procedures or laboratory tests and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
1386972|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for medical procedures and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
1386973|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for payments to health care professionals and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
1386974|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for over-the-counter medications and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
1387013|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||2 years|||||||
1387014|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||1 year|||||||
1387015|NCT01386632|Secondary|Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||1 year|||||||
1386975|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who were admitted to the hospital and with available data at given time point.|||admissions to the hospital||Standard Deviation|Mean
1386976|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
1386977|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited for any other medical service and with available data at given time point.|||visits for any other medical service||Standard Deviation|Mean
1386978|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
1386979|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited complementary/alternate therapy and with available data at given time point.|||complementary/alternate therapy visits||Standard Deviation|Mean
1386980|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
1386981|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had used an ambulance service and with available data at given time point.|||ambulance service uses||Standard Deviation|Mean
1386982|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
1387016|NCT01386632|Secondary|Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||3 months|||||||
1386983|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited a hospital emergency room and with available data at given time point.|||hospital emergency room visits||Standard Deviation|Mean
1386984|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
1386985|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited a healthcare professional and with available data at given time point.|||healthcare professional visits||Standard Deviation|Mean
1386986|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
1386987|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited a physician and with available data at given time point.|||physician visits||Standard Deviation|Mean
1386988|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
1386989|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient’s health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||Participants|||Count of Participants
1386990|NCT01386684|Secondary|International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit|IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.|Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36||||units on a scale||Standard Error|Mean
1387017|NCT01386632|Secondary|Two-year and Five-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.|Progression will be determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions.|Year 5||2020-06-30|06/2020||||
1386991|NCT01386684|Secondary|Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit|The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||units on a scale||Standard Error|Mean
1386992|NCT01386684|Secondary|Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit|The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||units on a scale||Standard Error|Mean
1386993|NCT01386684|Secondary|Prostatic Specific Antigen (PSA) Levels at Each Visit|Serum PSA was assessed at each study visit.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||ng/ml||Standard Deviation|Mean
1386994|NCT01386684|Secondary|Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit|Serum PSA was assessed at each study visit. The percentage of participants with serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL are provided at each time point.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available date at given time point|||percentage of participants|||Number
1386995|NCT01386684|Secondary|Total Serum Testosterone: Time to Increase Over Castrate Levels|Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.|36 months|All participants who achieved castrate testosterone levels (≤1.7 nmol/L)|||months||Standard Error|Mean
1386996|NCT01386684|Secondary|Total Serum Testosterone Levels at Each Visit|Total serum testosterone was assessed at each study visit.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||nmol/L||Standard Deviation|Mean
1386997|NCT01386684|Secondary|Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit|Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, > 0.7 to ≤ 1.7 nmol/L, and > 1.7 nmol/L are provided at each time point.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||percentage of participants|||Number
1386998|NCT01386684|Secondary|Castration Resistant Prostate Cancer (CRPC): Time to Event|CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.|36 months|All participants who achieved PSA levels ≤2 ng/mL|||months||Standard Error|Mean
1386999|NCT01386684|Secondary|Castration Resistant Prostate Cancer (CRPC): Number of Participants|CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests.|36 months|All participants who achieved PSA levels ≤ 2 ng/mL|||participants|||Number
1387000|NCT01386684|Primary|Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests|A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA > 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.|36 months||||months||Standard Error|Mean
1387001|NCT01386684|Primary|Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0|PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA > 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.|36 months||||months||Standard Error|Mean
1387002|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||5 years|||||||
1387003|NCT01386632|Secondary|Relative Toxicities During Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||End of treatment|||||||
1387004|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||3 months|||||||
1387005|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||2 years|||||||
1387006|NCT01386632|Secondary|HPV Status- Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).||3 months|||||||
1387007|NCT01386632|Secondary|Immune Response and Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).||3 months|||||||
1387008|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm .||5 year|||||||
1387009|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm.||2 year|||||||
1387010|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm .||1 year|||||||
1387024|NCT01386606|Post-Hoc|Morning Testosterone Correlated With Serial Testosterone.|"9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.~If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation."|Week 6|All Androxal subjects with Week 6 serial testosterone measurements.|||Number of Subjects|||Number
1387025|NCT01386606|Secondary|Change in Leuteinizing Hormone (LH)|Changes in morning LH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.|||mIU/mL||Standard Deviation|Mean
1387026|NCT01386606|Primary|24 Hour Average and Maximum Testosterone Concentration|"The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.~Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24."|Baseline and Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.|||ng/dL||Standard Deviation|Mean
1387027|NCT01386554|Secondary|Time to Single PCR Measured Remission (Complete or Partial)|Summary of patients with complete or partial remission (using 24-hour urine uPCR) at any visit up to week 48 (excludes Week 24 primary outcome measure data)|Up to Week 48||||Days||Standard Deviation|Mean
1387028|NCT01386554|Secondary|Proportion of Subjects That Have Sustained Complete or Partial Remission|The subject's response will be considered the average of the two PCR values from the 24-hour urine collections at Visit 8 (Week 24).|At Visit 9 (Week 28)||||Participants|||Count of Participants
1387029|NCT01386554|Primary|Proportion of Subjects Who Have a Complete or Partial Remission in Proteinuria|The subject's response will be considered the average of the two PCR values from the 24-hour urine collections at Visit 8 (Week 24). Urine protein creatinine ratio (uPCR) was used to assess remission (partial and complete). Complete remission = uPCR < 0.3 g/g; partial remission = uPCR < 50% of baseline uPCR and > 0.3 g/g but < 3.0 g/g|At Visit 8 (Week 24)||||Participants|||Count of Participants
1387030|NCT01386528|Secondary|Incidence of Inhibitors Against FIX (Coagulation Factor Nine)|Number of patients with inhibitory antibodies|During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||patients|||Number
1387031|NCT01386528|Secondary|Incidence of Serious Adverse Events (SAE)|The number of serious adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.|During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)|The safety analysis set consisted of all patients exposed to nanacog beta pegol.|||Events per patient year of exposure|||Number
1387032|NCT01386528|Secondary|Incidence of Adverse Events (AEs)|The number of adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.|during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)|The safety analysis set consisted of all patients exposed to nanacog beta pegol.|||events per patient year of exposure|||Number
1387033|NCT01386528|Secondary|Haemoglobin Pre- and Post-surgery Start|The mean pre-surgery and post surgery haemoglobin level.|0, 1 hour, 24 hours.|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||mmol/L||Standard Deviation|Mean
1387034|NCT01386528|Secondary|Transfusion Requirements (Fulfilling Transfusion Criteria)|Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.|during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||mL||Standard Deviation|Mean
1387035|NCT01386528|Secondary|Consumption of NNC-0156-0000-0009 (U/kg Body Weight)|Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.|During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||U/Kg||Standard Deviation|Mean
1387036|NCT01386528|Primary|Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)|"Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale:~– Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows:~Excellent: Better than expected/predicted in this type of procedure.~Good: As expected in this type of procedure.~Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.~Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required."|At the day of surgery|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||Haemostatic responses|||Number
1387037|NCT01386125|Primary|Change From Baseline in Total Polyp Size Score|An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
1387062|NCT01385644|Secondary|Percentage Change in 6 Minute Walk Distance Compared to Baseline|At 6 months 6 Minute Walk Distance was mesured and compared as a percentage to baseline|Baseline and 6 months post MSC infusion||||percentage of baseline||Inter-Quartile Range|Median
1387038|NCT01386125|Primary|Change From Baseline in Congestion/Obstruction Score|At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.|Baseline and Weeks 1-4|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
1387039|NCT01386008|Secondary|Investigator Fit Preference|Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.|||participants|||Number
1387040|NCT01386008|Primary|Ocular Health|Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.|Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. Change from baseline V1 over 30 days V4 cannot be analyzed.||||||
1387041|NCT01386008|Primary|Subjective Comfort Preference - Participants Preference Response|Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.|||participants|||Number
1387042|NCT01386008|Secondary|Investigator Surface Preference|Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.|||participants|||Number
1387043|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham|Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity.|20 Weeks||||units on a scale||Standard Deviation|Mean
1387044|NCT01385995|Secondary|Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP|20 weeks|All subjects with available fasting insulin, glucose measurements|||percentage of beta cell function||Standard Deviation|Mean
1387045|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham|The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.|20 weeks|All subjects with available fasting and and 2-hour insulin measurements are included.|||iIU/dL||Standard Deviation|Mean
1387046|NCT01385995|Secondary|Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham|Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)|20 weeks||||mg/dL||Standard Deviation|Mean
1387047|NCT01385995|Primary|Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)|Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL)|20 weeks|All available oral glucose tolerance test data was analyzed for the total sample.|||subjects|||Number
1387048|NCT01385748|Other Pre-specified|Overall Treatment Compliance According to the Patient Diary|"All participants complete a daily questionnaire during the active phase (radiotherapy). Compliance = [ number of tablets / (end date of treatment - start date treatment + 1 ) ] * 100. The number of tablets is the number of days with a tablet applied and treatment start and end dates are the first and last dates of the patient diary with a tablet applied."|8 weeks|Participants with evaluable data.|||percentage of compliance||Standard Deviation|Mean
1387049|NCT01385748|Other Pre-specified|Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher|Salivary flow was assessed and scored by the investigator weekly using the NCI-CTC scale for xerostomia for up to 8 weeks during the active phase (radiotherapy). Time to appearance of Grade 2 or higher on the following 4-point scoring scale is reported: 0 = normal; 1 = symptomatic (dry or thick saliva) without significant dietary alteration (unstimulated saliva flow greater than 0.2 mL/minute); 2 = symptomatic and significant oral intake alterations (e.g. copious water, other lubricants, diet limited to purees and/or soft, moist foods) (unstimulated saliva 0.1 to 0.2 mL/minute); and 3 = symptoms leading to inability to adequately aliment orally, intravenous fluids, tube feedings, or total parenteral nutrition indicated (unstimulated saliva < 0.1 mL/minute).|8 weeks|Two of the 183 participants received study treatment but withdrew early without any safety assessments (1 in the clonidine Lauriad 50 μg group and 1 in the clonidine Lauriad 100 μg group). The safety population therefore included 181 participants.|||weeks||95% Confidence Interval|Median
1387063|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by FVC Compared to Baseline|Forced Vital Capacity (FVC) was measured and reported as a percentage of predicted and comapred from 6 months post-infusion to baseline|6 months post MSC infusion||||percentage of baseline||Inter-Quartile Range|Median
1402532|NCT01243320|Secondary|Change Systolic Blood Pressure|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mmhg||95% Confidence Interval|Mean
1387050|NCT01385748|Other Pre-specified|The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.|The presence of grade 3 or 4 oral mucositis on the World Health Organization (WHO) oral mucositis severity scale was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.The number of participants with at least one Grade 3 or Grade 4 mucositis score during the active phase is reported.|8 weeks|Missing = participants without a WHO score during the active phase|||participants|||Number
1387051|NCT01385748|Other Pre-specified|The Maximum Severity of Oral Mucositis|Participants were assessed using the World Health Organization (WHO) oral mucositis severity scale twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. The WHO scores were as follows: 0 = None; 1 = oral soreness, erythema; 2 = oral erythema, ulcers, solid diet tolerated; 3 = oral ulcers, liquid diet only; 4 = oral alimentation impossible. The maximum severity was the maximum score reported during the active phase.|8 weeks||||participants|||Number
1387052|NCT01385748|Other Pre-specified|Time to Onset of Severe Oral Mucositis|Time to onset is the duration until first Severe Oral Mucositis. Severe Oral Mucositis was defined as a Grade 3 or Grade 4 score on the World Health Organization (WHO) oral mucositis severity scale. Participants were assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.|8 weeks||||weeks||95% Confidence Interval|Median
1387053|NCT01385748|Secondary|Overall Survival|After the end-of study visit, the investigator center collects OS follow-up data for each patient who has consented to participate in the follow-up data collection. the OS follow-up period was still ongoing at time of the primary analysis and ended in Nov 2016. The analysis was condicted on the ITT population. The overall survival was evaluate every 6 months after last subject completed in patients who has consented to participate .|2 years|The population for the 2-year OS follow-up was the ITT defined as all patients who received at least 1 dose of investigational drug.|||months||95% Confidence Interval|Median
1387054|NCT01385748|Secondary|Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range)|Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.|8 weeks|Participants with at least one use of an opioid during the active phase with evaluable data.|||morphine dose equivalent||Full Range|Median
1387055|NCT01385748|Secondary|Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation)|Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.|8 weeks|Participants with at least one use of an opioid during the active phase with evaluable data.|||morphine dose equivalent||Standard Deviation|Mean
1387056|NCT01385748|Secondary|At Least One Opioid Use (Class 3 Analgesic)|Opioid use was recorded twice weekly during the active phase (radiotherapy)|8 weeks||||participants|||Number
1387057|NCT01385748|Primary|Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed|The primary endpoint planned in the protocol was the percentage of participants with an oral mucositis score greater than or equal to 3 using the WHO oral mucositis severity scale at a cumulative radiation dose of 50 Gy. This was modified by protocol amendment to the cumulative radiation dose at which a WHO score greater than or equal to 3 was first observed. This change was made to account for the fact that in real practice most patients receive a cumulative dose between 60 and 70 Gy. The presence of grade 3 or 4 oral mucositis was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = oral ulcers, liquid diet only; WHO score 4 = oral alimentation impossible. Each assessment was associated with the actual cumulative dose of radiotherapy.|8 weeks|The analysis was conducted on the Intent to treat population, defined as all participants who received at least one dose of investigational drug.|||Cumulative radiation dose (Gy)||95% Confidence Interval|Median
1387058|NCT01385696|Secondary|Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2|"The correct use of devices will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice (visit 2).~Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose."|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.|||Percentage of Patients|||Number
1387059|NCT01385696|Secondary|Mean Overall Satisfaction With Genuair and Handihaler at Visit 2|The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 5 [very satisfied]) after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.|||Units on a scale (1-5)||95% Confidence Interval|Mean
1387060|NCT01385696|Primary|Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2|Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data was handled via the observed cases approach.|||Percentage of Patients|||Number
1387061|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline|DLCO was measured as a percentage of predicted, and the percentage change between 6 months post-infusion and baseline is reported.|6 months post MSC infusion||||percentage of baseline||Inter-Quartile Range|Median
1387065|NCT01385579|Primary|Completion of a Colorectal Cancer Screening|Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)|within 4 months of the initiation of outreach (by June 30, 2010)||||participants|||Number
1387066|NCT01385566|Primary|Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)|Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
1387067|NCT01385566|Primary|Number of Participants Reporting Systemic Adverse Experiences|Systemic AEs included all reported AEs except injection-site AEs|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
1387068|NCT01385566|Primary|Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)|The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.|Up to 5 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||Participants|||Number
1387069|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention|Within 5 days after the blood draw at approximately 20 months following vaccine administration|The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up|||Participants|||Number
1387070|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience (SAE)|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
1387071|NCT01385566|Primary|Number of Participants Reporting an Adverse Experience (AE)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
1387072|NCT01385566|Primary|Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies|VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.|Baseline and 6 weeks following vaccine administration|The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.|||Geometric mean fold change||90% Confidence Interval|Geometric Mean
1387073|NCT01385371|Secondary|Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)|For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants <12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.entry.|||score on a scale||Full Range|Median
1387074|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Peak GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Standard Error|Mean
1387075|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Peak GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
1387149|NCT01384292|Primary|Response (Responder/Non-responder) to Study Drug|Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.|Baseline to Week 4|All randomized patients|||Participants|||Number
1387076|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Entire GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Standard Error|Mean
1387077|NCT01385371|Secondary|Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS|The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants ≥12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
1387078|NCT01385371|Secondary|Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.~For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.~For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
1387079|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Entire GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
1387080|NCT01385371|Primary|Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.~For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.~For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Entire GPS (expected average duration of 5 to 6 weeks)|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
1387081|NCT01385293|Secondary|Time to New Metastatic Disease From the Baseline Visit|Time in days from the start of study treatment to time of new metastatic disease. Time to new metastatic disease is, defined from the date of first study agent administration to the onset of a new evaluable site of disease as per PCWG2 and RECIST 1.1 guidelines, excluding the primary site and all sites documented at baseline will be assessed. Only those patients that experienced a new lesion per this definition are included.|5 years|Only those patients that experienced a new lesion per this definition are included.|||days||Full Range|Median
1387082|NCT01385293|Secondary|Change in Circulating Tumor Cell (CTC) Levels From Baseline|The number of patients with a baseline CTC level of at least 5 who achieved a CTC level of less than 5 during the study.|2 years|13 patients had measured CTC levels above 5 at baseline|||participants|||Number
1387083|NCT01385293|Secondary|Overall Survival of Participants.|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|5 years|Intent to treat|||months||95% Confidence Interval|Median
1387084|NCT01385293|Secondary|Prostate Specific Antigen (PSA) Response|The number of patients with a 30% and 50% decrease in PSA from baseline.|2 years|Intent to treat|||participants|||Number
1387085|NCT01385293|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of patients experiencing grade 3-5 adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 28 days post last study drug dose. This is the follow-up safety visit.|Intent to treat|||participants|||Number
1387086|NCT01385293|Secondary|Radiologic Response|The number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Response and progression is evaluated using a combination of the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|Intent to treat|||participants|||Number
1387150|NCT01384019|Secondary|Reperfusion Success|microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR|3-5 days|||||||
1387087|NCT01385293|Primary|Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event.|"Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.~Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|5 years|Intent to treat|||months||95% Confidence Interval|Median
1387088|NCT01385202|Secondary|Rate of Acute Success|Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).|End of procedure|The analysis population for this endpoint includes two groups; a): Calibration Roll-in subjects who were prospectively identified prior to the study procedure and b) the Effectiveness Cohort. Both groups underwent an AF ablation procedure with the study catheter.|||percentage of participants|||Number
1387089|NCT01385202|Primary|Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.|Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.|7 days of the AF ablation procedure|Safety cohort includes all enrolled subjects who had the study catheter inserted.|||Percentage of patients with primary AE||95% Confidence Interval|Number
1387090|NCT01385202|Primary|The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up|The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).|12-months|Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia.|||percentage of participants||95% Confidence Interval|Number
1387091|NCT01385189|Secondary|IgG Antibody Response to Na-GST-1|Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126, as determined by an indirect enzyme-linked immunosorbent assay (ELISA)|126 days post dose 1||||Arbitrary Units||Standard Deviation|Mean
1387092|NCT01385189|Primary|Immediate Vaccine Related Adverse Events|Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1|2 hours post vaccination||||Participants|||Count of Participants
1387093|NCT01385137|Secondary|Week 12 Functional Assessment of Cancer Therapy–Endocrine Symptoms (FACT-ES) Score|FACT-ES measures physical, social and family, emotional, and functional well-being and endocrine symptoms. The FACT scaleshave five response levels (“not at all” to “very much”), where higher scores reflect better well-being and fewer symptoms. This scale provided a measure of the broader impact of join pain and stiffness symptoms. Score range is 0 to 220.|12 weeks post-registration||||FACT-ES score||95% Confidence Interval|Mean
1387094|NCT01385137|Secondary|Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score|Linear regression model-adjusted week 12 mean score by treatment group. Higher scores represent higher symptom burden. Range is 0 to 100.|12 weeks post-registration||||M-SACRAH score||95% Confidence Interval|Mean
1387095|NCT01385137|Secondary|Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score|Linear regression model-adjusted week 12 mean score by treatment group The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). Higher scores indicate higher symptom burden.|12 weeks post-registration||||WOMAC score||95% Confidence Interval|Mean
1387096|NCT01385137|Secondary|Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 25 weeks|All participants receiving at least some protocol treatment|||Participants|||Number
1387097|NCT01385137|Primary|Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score|"Linear regression model-adjusted week 12 mean score by treatment group.~Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10"|12 weeks post-registration||||BPI score||95% Confidence Interval|Mean
1387098|NCT01385098|Secondary|Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy|We anticipate that vitamin D supplementation of Roux-en Y bariatric surgery patients will be less effective in improving or maintaining vitamin D status.|Baseline and 12 weeks||||ng/mL||Standard Deviation|Mean
1387099|NCT01385098|Primary|Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation|Serum 25(OH)D ng/ml levels at baseline and 12 weeks following bariatric surgery|baseline and 12 weeks||||ng/mL||Standard Deviation|Mean
1387108|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
1387100|NCT01385033|Primary|Amyloid Plaque Burden Threshold Determined by the Trimmed HE Sample Mean and SD Brain Cortical [18F]MK-3328 SUVR|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and SD (trimmed). This step is performed to remove HE participants with positive plaque burden. Using HE data, the threshold for classification of plaque burden as positive/negative will be calculated as mean (trimmed) + k*SD (trimmed). Value of k will be chosen to fine tune sensitivity/specificity, with specificity of at least 0.9 in the sub-group remaining after trimming of data.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of an amyloid plaque burden threshold using PET imaging data obtained after [18F]MK-3328 administration was not performed.||||||
1387101|NCT01385033|Primary|Brain Cortical [18F]MK-3328 SUVR in AD Participants and HE Participants|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulated gyrus, posterior cingulated gyrus, temporal cortex, lateral temporal cortex and occipital cortices). A trimming procedure will be applied to remove the sub-population of HE participants who have positive amyloid plaque burden. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and standard deviation (SD)(trimmed).|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of brain cortical [18F]MK-3328 SUVR values in AD and HE participants was not performed.||||||
1387102|NCT01385033|Primary|Area Under the Receiver Operating Curve (AUC of ROC) for Distinguishing Between AD and HE Participants Based on Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR)|Using PET brain images acquired after dosing, regions of interest (ROIs) are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue time-activity curves (TACs). SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices). The receiver operating curve (ROC) for determining whether a participant is in HE or AD group by using cortical SUVR values is determined. The ROC is a plot of sensitivity on the y-axis versus 1-specificity (false positive rate) on the x-axis for the range of cortical SUVR threshold values. The AUC of ROC is determined.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the potential of [18F]MK-3328 to distinguish between AD and HE participants was not assessed.||||||
1387103|NCT01384760|Secondary|Epworth Sleepiness Score (ESS)|The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness. It was first described in 1991 as a simple, self-administered questionnaire. The questionnaire is based on eight common situations in life. Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances. This gives a total score of 0 to 24 in each subject.The total score ranges from 0 to 24, with higher scores indicating higher sleepiness.|1 year||||units on a scale||Standard Deviation|Mean
1387104|NCT01384760|Primary|Apnea-hypopnea Index (AHI) at One Year|AHI is a count of the number of upper airway obstruction per hour of sleep. The index will be derived from the overnight home sleep study.|1 year||||events per hour||Standard Deviation|Mean
1387105|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test|Data for 1 subject was not recorded|||units on a scale||Standard Deviation|Mean
1387106|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
1387107|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - directly after handgrip fatigue test||||units on a scale||Standard Deviation|Mean
1387109|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test|Data for 1 subject was not collected.|||units on a scale||Standard Deviation|Mean
1387110|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
1387111|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - directly after handgrip fatigue test||||units on a scale||Standard Deviation|Mean
1387112|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
1387113|NCT01384591|Secondary|Global Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score range 0 to 10, with a higher score indicating a worse outcome."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
1387114|NCT01384591|Secondary|Global Fatigue Score as Measured by Brief Fatigue Inventory at Baseline|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score ranges (0 to 10) with higher score indicating a worse outcome."|Baseline||||units on a scale||Standard Deviation|Mean
1387115|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
1387116|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
1387117|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the vigor scale is 0 to 24, with the higher number meaning more vigor.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
1387148|NCT01384539|Primary|Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.|EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.|6 months||||percent change in FMD||Standard Deviation|Mean
1387118|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the vigor scale is 0 to 24, with the higher number meaning more vigor.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
1387119|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
1387120|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
1387121|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
1387122|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
1387123|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
1387124|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
1387125|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
1387126|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
1387127|NCT01384591|Secondary|Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention|Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.|Post dose three of the intervention, average of 17 hours post dose one intervention|Data from 2 subjects was not recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
1387128|NCT01384591|Secondary|Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention|Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.|Post dose three of the intervention, average of 17 hours post dose one intervention|Data for 2 subjects not recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
1387129|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
1387130|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
1387131|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
1387132|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
1387133|NCT01384591|Secondary|Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline|Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.|baseline|Data for 2 subjects was not recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
1387134|NCT01384591|Secondary|Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline|Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction after fatigue test.|baseline|Data for 2 subjects wasn't recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
1387135|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
1387136|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
1387137|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
1387138|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
1387139|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|2 hours post dose three of the intervention and a meal, average of 19 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
1387140|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|1 hour post dose three of the intervention and a meal, average of 18 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
1387141|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|Post dose three of the intervention and a meal, average of 17 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
1387142|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|2 hours post dose two of the intervention, average of 14 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
1387143|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|1 hour post dose two of the intervention, average of 13 hours post dose 1 of the intervention|Missed blood flow measurement on one placebo participant at this time point.|||ml/minute||Standard Deviation|Mean
1387144|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|12 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
1387145|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|Baseline||||ml/minute||Standard Deviation|Mean
1387146|NCT01384539|Secondary|Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB|The effect of calcitriol and cholecalciferol supplementation will be evaluated calculating the mean change in total vascular endothelial cell NFkB expression|6 months||||units of ratio relative to HUVEC||Standard Deviation|Mean
1387147|NCT01384539|Secondary|Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein|Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation|6 months||||mg/dL||Inter-Quartile Range|Median
1402998|NCT01238211|Secondary|Overall Survival|Overall survival (OS) is defined as time from registration to death. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|||||||
1387152|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
1387153|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1387154|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1387155|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
1387156|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1387157|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1387158|NCT01383993|Secondary|Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration|Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration|AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Mean
1387159|NCT01383993|Primary|Number of Participants Assessed Visual Questionnaire||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.|||participants|||Number
1387160|NCT01383993|Primary|Number of Participants Assessed Color Vision Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.|||participants|||Number
1387161|NCT01383993|Primary|Number of Participants Assessed Near Distance Visual Acuity Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.|||participants|||Number
1387162|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
1387163|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1387164|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1387165|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
1387166|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1387167|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1387168|NCT01383954|Primary|Percent Change From Baseline in Pain Score During Week 2|Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement.|Baseline and Week 2|Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.|||percent change||Standard Deviation|Mean
1387169|NCT01383954|Primary|Percent Change From Baseline in Pain Score During Week 1|Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.|Baseline and Week 1|Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.|||percent change||Standard Deviation|Mean
1387170|NCT01383928|Secondary|Phase 2: Overall Survival|Overall survival was measured as the time from the date of first dose of study treatment to the time of death plus 1 day. For participants who did not die, survival was censored at the date of last contact. Overall Survival was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline up to treatment cycle 35|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||months||95% Confidence Interval|Median
1387171|NCT01383928|Secondary|Phase 2: Percentage of Participants Achieving Survival at Year 1||1 year after the first dose of study treatment|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||participants||95% Confidence Interval|Number
1387172|NCT01383928|Secondary|Phase 2: Progression Free Survival (PFS)|PFS was defined as the time from the date of first dose of study treatment to the date of first documentation of progressive disease or to death due to any cause, whichever occurred first plus 1. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved,uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants who received ASCT or an alternate anticancer therapy were censored at the last response assessment that was SD or better before initiation of therapy. Participants without a response assessment were censored at the date of first dose. PFS was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline until progressive disease (up to treatment cycle 35)|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||months||95% Confidence Interval|Median
1387173|NCT01383928|Secondary|Phase 2: Time to Disease Progression (TTP)|Time to progression was defined as the time from the date of first dose of study treatment to the date of first documentation of PD + 1 day. Participants that did not experience PD will be censored at the last response assessment that is SD or better. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants that received Autologous Stem Cell Transplantation (ASCT) or an alternate cancer therapy were also be censored at the last response assessment that is, SD or better prior to initiation of therapy. Participants without response assessment will be censored at the date of first dose. TTP was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline until progressive disease (up to treatment cycle 35)|modified-intent-to-treat (mITT) population included all participants who received at least one dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||months||95% Confidence Interval|Median
1387174|NCT01383928|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as >=25% increase from lowest value in: serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; development of new bone lesions or soft tissue plasmacytomas development or increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcaemia development.|Baseline until end of study treatment (up to treatment cycle 35)|Included a subset of response-evaluable population who achieved response.|||months||95% Confidence Interval|Median
1387175|NCT01383928|Secondary|Phase 2: Time to Response|Time to first response is defined as the time from the date of first dose of study treatment to the date of the first documentation of a confirmed response (PR or better) in a participant who responded + 1 day. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.|||months||Full Range|Median
1387176|NCT01383928|Primary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
1387177|NCT01383928|Primary|Phase 2: Percentage of Participants Experiencing Serious Adverse Events|A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least one dose of any study drug.|||percentage of participants|||Number
1387178|NCT01383928|Secondary|Phase 2: Percentage of Participants With Minimal Response (MR)|MR as per IMWG criteria is 25%-49% reduction in serum paraprotein and 50%-89% reduction in urine light chain excretion for 6 weeks.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387179|NCT01383928|Secondary|Phase 2: Percentage of Participants With Partial Response (PR)|PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387180|NCT01383928|Secondary|Phase 2: Percentage of Participants With Near Complete Response (nCR)|nCR as per IMWG criteria is positive immunofixation analysis of serum or urine as the only evidence of disease; appearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387181|NCT01383928|Secondary|Phase 2: Percentage of Participants With Very Good Partial Response (VGPR)|VGPR as per IMWG criteria is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387182|NCT01383928|Secondary|Phase 2: Percentage of Participants With Stringent Complete Response (sCR)|sCR as per IMWG criteria is CR plus normal FLC ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387183|NCT01383928|Secondary|Phase 2: Pecentage of Participants With Complete Response (CR)|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of study treatment (up to treatment cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387184|NCT01383928|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) After Cycles 4, 8, and 16|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR were applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein; Urine M-protein; Serum FLC assay.|Cycles 4, 8, and 16|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387185|NCT01383928|Secondary|Phase 2: Percentage of Participants With Objective Response|Objective response is defined as CR, VGPR or PR based on IMWG Response Criteria for malignant lymphoma. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein+urine M-protein level <100 mg/24h. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes.|Baseline until end of study treatment (up to Cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1387194|NCT01383928|Secondary|Phase 1: AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib|AUC(0-72) is a measure of the area under the plasma concentration time-curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
1387186|NCT01383928|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. As per Common Terminology Criteria for Adverse Events v4.0 (CTCAE), Grade 3 = AE with severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = AE with life-threatening consequences; urgent intervention indicated and Grade 5 = Death related to AE.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
1387187|NCT01383928|Primary|Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR)|CR as per International Myeloma Working Group (IMWG) uniform criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR was applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein greater than or equal to (>=)1 g/dL; Urine M-protein >=200 mg/24 hours; Serum FLC assay level >=10 mg/dL, provided serum FLC ratio was abnormal.|Baseline up to treatment cycle 35|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1387188|NCT01383928|Primary|Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure and heart rate.|Baseline and Day 1 of each treatment cycle up to 35 treatment cycles|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1387189|NCT01383928|Primary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity|TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.|||participants|||Number
1387190|NCT01383928|Primary|Phase 1: Number of Participants With Change From Baseline Value in Clinical Laboratory Test Results to Worst Value|Number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology (white blood cell [WBC] count, lymphocytes, neutrophils, platelets, hemoglobin), clinical chemistry and urinalysis were performed. Number of participants with baseline laboratory values as per National Cancer Institute Common Terminology Criteria (NCI CTC) grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes to the worst CTC grade were presented. Baseline value defined as value collected at time closest to, but prior to, first dose of study drug on Cycle 1 Day 1. Worst post-baseline value defined as worst value between first dose of any study drug and End of Study (EOS) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for corrected calcium, glucose, magnesium, potassium and sodium irrespective of change in the CTC grade.|Baseline and Cycle 1 up to Cycle 35|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.|||participants|||Number
1387191|NCT01383928|Secondary|Phase 1: Percentage of Participants With Best Overall Response|Best response observed during study.CR:no immunofixation on serum,urine;soft tissue plasmacytomas disappearance;<5% plasma cells in bone marrow.Stringent CR(sCR):CR as defined,normal free light chain ratio,absence of clonal cells in bone marrow.Partial response(PR):>=50% reduction of serum M-protein,urinary M-protein by >=90%/to <200 mg/24 hr reduction.Near CR(nCR):positive immunofixation of serum/urine;soft tissue plasmacytomas disappearance;<=5% plasma cells in bone marrow.VGPR:serum,urine M-protein detectable by immunofixation but not on electrophoresis/>=90% reduction in serum M-protein+urine M-protein level <100 mg/24hr.Stable disease (SD):failure to attain CR,VGPR,PR/progressive disease (PD).PD:>=25% increase from lowest value in:serum/urine M-component;difference between involved,uninvolved FLC levels;bone marrow plasma cell percent;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise;hypercalcaemia development.|Baseline until end of study treatment (up to Cycle 35)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment. Results were summarized together for all Phase 1 participants, as per planned analysis. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1387192|NCT01383928|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC (0-72) on Day 11 to the AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||ratio||Standard Deviation|Geometric Mean
1387193|NCT01383928|Secondary|Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||hours||Full Range|Median
1387208|NCT01383720|Other Pre-specified|Mean Aortic Valve Gradient|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||mm Hg||Standard Deviation|Mean
1403382|NCT01235338|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
1387195|NCT01383928|Secondary|Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|Pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1387196|NCT01383928|Primary|Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
1387197|NCT01383928|Primary|Phase 1: Recommended Phase 2 Dose (RP2D)|The RP2D of ixazomib was determined after the evaluation of the available data from the phase 1 portion of the trial which included, but was not limited to analyses of efficacy results, toxicity characterization, all grades peripheral neuropathy, and treatment discontinuation.|Cycle 1 up to Cycle 35|Safety population included all participants who received at least 1 dose of any study drug.|||mg|||Number
1387198|NCT01383928|Primary|Phase 1: Maximum Tolerated Dose (MTD)|MTD was highest dose of ixazomib given with combination drugs, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >14 days; <=80% lenalidomide doses administered due to other >=Grade 2 combination study drug-related nonhematologic toxicities requiring therapy discontinuation.|Cycle 1|DLT-evaluable population included all participants who received all Cycle 1 doses of MLN9708 and completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in Phase 1.|||mg|||Number
1387199|NCT01383720|Other Pre-specified|Acute Kidney Injury - Stage 2 or 3|"Stage 2: Increase in serum creatinine to 200-300% (2.0-3.0 times increase compared with baseline).~Stage 3: Increase in serum creatinine to ≥ 300% (> 3 times increase compared with baseline) or serum creatinine of ≥ 4.0 mg/d (≥ 354 μmol/L) with an acute increase of at least 0.5 mg/dl (44 μmol/L). Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria."|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387200|NCT01383720|Other Pre-specified|Bleeding|"Life-threatening or Disabling Bleeding~Fatal bleeding OR~Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR~Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR~Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units~Major Bleeding~Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC AND~Does not meet criteria of life-threatening or disabling bleeding"|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387201|NCT01383720|Other Pre-specified|New Conduction Disturbances or Arrhythmias Requiring Permanent Pacemaker||Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387202|NCT01383720|Other Pre-specified|Major Vascular Complication|"Any thoracic aortic dissection~Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, or compartment syndrome) leading to either death, need for significant blood transfusions (≥4 units), unplanned percutaneous or surgical intervention, or irreversible end-organ damage (e.g. hypogastric artery occlusion causing visceral ischemia or spinal artery injury causing neurologic impairment)~Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage"|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387203|NCT01383720|Other Pre-specified|Urgent/Emergent Conversion to Surgery or Repeat Procedure for Valve-related Dysfunction||Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387204|NCT01383720|Other Pre-specified|Major Stroke|Confirmed with a Modified Rankin score >/= 2 at 30 and 90 days|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387205|NCT01383720|Other Pre-specified|Peri-procedural Myocardial Infarction|"Peri-Procedural Myocardial Infarction (≤72 hours after the index procedure)~New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs (e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, or imaging evidence of new loss of viable myocardium or new wall motion abnormality), AND~Elevated cardiac biomarkers (preferably creatine kinase-myoglobin band) within 72 h after the index procedure, consisting of two or more post-procedure samples that are > 0.6 to 8 h apart with a 20% increase in the second sample and a peak value exceeding 10X the 99th percentile upper reference limit (URL), or a peak value exceeding 5X the 99th percentile URL with new pathological Q waves in at least 2 contiguous leads"|72 hours||||participants|||Number
1387206|NCT01383720|Other Pre-specified|Death||Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387207|NCT01383720|Other Pre-specified|Aortic Valve Area|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||cm^2||Standard Deviation|Mean
1387209|NCT01383720|Other Pre-specified|No Major Adverse Cardiovascular and Cerebrovascular Events Through Discharge|Major adverse cardiovascular or cerebrovascular events include all-cause mortality, periprocedural myocardial infarction ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387210|NCT01383720|Other Pre-specified|Single Valve Implanted in the Proper Anatomical Location||procedure||||participants|||Number
1387211|NCT01383720|Other Pre-specified|Intended Performance of the Lotus Valve|Aortic valve area >1.0 cm2 plus either a mean aortic valve gradient <20 mmHg or peak velocity <3m/sec, without moderate or severe prosthetic valve aortic regurgitation|At time of discharge or 7 days post procedure||||participants|||Number
1387212|NCT01383720|Other Pre-specified|Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System||Procedure||||participants|||Number
1387213|NCT01383720|Secondary|Paravalvular Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387214|NCT01383720|Secondary|Central Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
1387215|NCT01383720|Secondary|Device Performance Endpoint-Valve Retrieval, if Attempted|Successful retrieval of the Lotus Valve System if retrieval is attempted|procedure||||participants|||Number
1387216|NCT01383720|Secondary|Device Performance Endpoint-Repositioning|Successful repositioning of the Lotus Valve System if repositioning is attempted|procedure|Patients in whom repositioning of the Lotus Valve was attempted|||participants|||Number
1387217|NCT01383720|Primary|Clinical Procedural Success|Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.|Discharge or 7 days post-procedure, whichever comes first|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis|||participants|||Number
1387218|NCT01383707|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first study drug administration to the date of death due to any cause. Participants who were alive at the time of the analysis were censored at the last date the participant was known to be alive. OS was calculated as follows: OS (months) = ([Date of Death - first study drug administration] + 1)/30|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||months||95% Confidence Interval|Median
1387219|NCT01383707|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first study drug administration to the date of disease progression or death due to any cause, whichever came first. Progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants, who did not progress were censored at the date of the last assessment performed. Participants who withdrew from the study without documented progression and for whom an electronic case report form (eCRF) existed as evidence that evaluations had been made, were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessments, but known to be alive were censored at the time of first study drug administration. PFS was calculated: PFS (months) = ([Date of Event - Date of first study drug administration] + 1)/30.|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||months||95% Confidence Interval|Median
1387220|NCT01383707|Secondary|Disease-free Interval (DFI)|DFI was defined as the time from the date of R0/R1 surgery to the date of disease relapse or death due to any cause. Participants who did not progress were considered censored at the date of the last assessment performed. For participants receiving two-stage resection, the date of R0/R1 surgery was the date of the second surgery. Participants, who did not receive surgery and participants without R0/R1 surgery were censored at Day 1. DFI was calculated as follows: DFI (months) = ([Date of R0/R1 surgery ‐ Date of 1st relapse/Death] + 1)/30|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||months||95% Confidence Interval|Median
1387221|NCT01383707|Secondary|Percentage of Participants Achieving No Residual Tumor (R0)/Surgical Margin With Microscopic Residual Tumor (R1) Liver Resection|The percentage of participants achieving R0/R1 liver resection was defined as the percentage of participants achieving R0 surgery (no residual tumor) plus percentage of participants achieving R1 surgery (surgical margin with microscopic residual tumor).|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||percentage of participants||95% Confidence Interval|Number
1387222|NCT01383707|Primary|Objective Response Rate (ORR) in the Per-protocol Analysis Set (PPAS)|ORR was defined as the percentage of participants with shrinkage (PR) or disappearance of cancer (CR). Tumor response was evaluated according to the RECIST v1.1. The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of CT scan (abdomen + pelvis + chest) or CE-MRI (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The PPAS included all subjects in the ITT set, who did not experience any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1387223|NCT01383707|Primary|Objective Response Rate (ORR) in the Intent-to-treat (ITT) Analysis Set|ORR was defined as the percentage of participants with shrinkage (partial response [PR]) or disappearance of cancer (complete response [CR]). Tumor response was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of computerized tomography (CT) scan (abdomen + pelvis + chest) or contrast-enhanced magnetic resonance imaging (CE-MRI) (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||percentage of participants||95% Confidence Interval|Number
1387225|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Baseline|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.||||||
1387226|NCT01383616|Secondary|Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.|||percent change||Standard Deviation|Mean
1387227|NCT01383616|Secondary|Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
1387228|NCT01383616|Secondary|Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. A score of 0 indicates no back pain, while a score of 24 indicates significant back pain.|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
1387229|NCT01383616|Secondary|Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups|Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.[2] The scores for all questions answered are summed. Zero is equated with no disability and 50 is the maximum disability possible|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
1387230|NCT01383616|Secondary|Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain|3 months post-op|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.|||units on a scale||Standard Deviation|Mean
1387231|NCT01383616|Secondary|Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.|3 months post-op|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.|||units on a scale||Standard Deviation|Mean
1387232|NCT01383616|Secondary|Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.|||percent change||Standard Deviation|Mean
1387233|NCT01383616|Secondary|Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.|||percent change||Standard Deviation|Mean
1387234|NCT01383616|Primary|Change in RDQ in the Bipedicular Group From 3 to 12 Months|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.|3-12 months post operation|From the period of intervention to 12 month follow-up, 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
1403383|NCT01235338|Primary|Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
1387235|NCT01383616|Primary|Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.|||units on a scale||Standard Deviation|Mean
1387236|NCT01383499|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model. The scores for this question used the following scale where: 1='Did not wake up', 2='Woke up once', 3='Woke up 2-5 times', 4='Woke up more than 5 times' and 5='Was awake all night'.|Baseline and last week of treatment (week 4)|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||scores on a scale||Standard Error|Least Squares Mean
1387237|NCT01383499|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with at least one on-treatment value.|||Score||Standard Error|Least Squares Mean
1387238|NCT01383499|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day (24 h, daytime and night-time use). Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||Puffs||Standard Error|Least Squares Mean
1387239|NCT01383499|Secondary|Mean Evening PEF Response|Mean Evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||Litre/min||Standard Error|Least Squares Mean
1387240|NCT01383499|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||Litre/min||Standard Error|Least Squares Mean
1387241|NCT01383499|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
1387242|NCT01383499|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
1387243|NCT01383499|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
1387244|NCT01383499|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
1387245|NCT01383499|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
1387246|NCT01383499|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.|||Litre||Standard Error|Least Squares Mean
1387285|NCT01383317|Secondary|Pain Unpleasantness|Pain unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they refused to answer or they were discharged.|||units on a scale||Standard Deviation|Mean
1387247|NCT01383486|Secondary|The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score </= 60 at visit 1.|Up to 14 days|Subgroup of Selection Evaluation Population: low literacy participants who had REALM score </= 60 at visit 1 and chose naproxen sodium.|||Percentage of participants|||Number
1387248|NCT01383486|Secondary|The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours||Within 24 hours of their selection decision taken up to 14 days|Subgroup of Selection Evaluation Population|||Percentage of participants|||Number
1387249|NCT01383486|Primary|The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).|up to 14 days|Only subjects who chose naproxen sodium were included in the analysis.|||Percentage of participants|||Number
1387250|NCT01383447|Secondary|Predictive Values of Levels of Flow Cytometric Minimal Residual Disease (MRD) on Duration of Progression Free Survival for the Study Population|Kaplan-Meier PFS curves and cumulative incidence of progression curves will be generated for patients above vs. below each threshold, and log rank will be used to compare the curves.|Day 29|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
1387251|NCT01383447|Secondary|Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of Entinostat Alone vs. Entinostat Plus Imatinib Mesylate|Entinostat concentrations will be compared when administered alone or in combination with imatinib by paired Student’s t test (day 4 vs 11 concentrations) or Wilcoxon signed rank tests as appropriate. Association between exposure parameters and PD endpoints (e.g., apoptosis, histone acetylation, BCR-ABL expression) will be assessed using Fisher’s exact tests or Wilcoxon rank sum tests as appropriate.|Day 4 and 11|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
1387252|NCT01383447|Secondary|Progression Free Survival (PFS) for Adults With Relapsed/Refractory Ph+ ALL Treated With Combination of Entinostat and Imatinib Mesylate|The Kaplan-Meier estimator will be used to estimate PFS with a 95% confidence interval from study entry.|At 1 year|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
1387253|NCT01383447|Secondary|Rate of Complete Response (CR) for Adults With Relapsed/Refractory Ph+ ALL Treated With a Combination of Entinostat (at the Dose Determined in Phase 1) and Imatinib Mesylate||Up to 30 days post-treatment|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
1387254|NCT01383447|Primary|Maximum Tolerated Dose (MTD) of Entinostat When Given in Combination With Imatinib Mesylate|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.|Up to 30 days post-treatment|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
1387255|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 78|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
1387256|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 52|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
1387257|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 24|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
1387258|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 12|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 12|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
1387283|NCT01383356|Primary|Area Under the Curve 0 to Last Measurable Value (AUC0-t)|AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period|||ng*h/ml||Standard Deviation|Mean
1387259|NCT01383421|Other Pre-specified|Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78|The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing Baseline and at least 1 non-missing post-Baseline value. Observed cases.|||units on a scale||Standard Deviation|Mean
1387260|NCT01383421|Other Pre-specified|Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 3 or 4 at Baseline. Non-responder imputation.|||percentage of participants|||Number
1387261|NCT01383421|Other Pre-specified|Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 4 at Baseline. Non-responder imputation.|||percentage of participants|||Number
1387262|NCT01383421|Other Pre-specified|Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants|||Number
1387263|NCT01383421|Other Pre-specified|Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78|"The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors don't agree at all (score = 1), don't agree (score = 2), agree (score = 3), and agree very much (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance)."|Baseline, Week 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387264|NCT01383421|Other Pre-specified|Mean Change From Baseline in TSQM Scores at Week 78|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387265|NCT01383421|Other Pre-specified|Mean Change From Baseline in TSQM Scores at Week 52|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387266|NCT01383421|Other Pre-specified|Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387267|NCT01383421|Other Pre-specified|Mean Change From Baseline in WPAI at Week 78|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387268|NCT01383421|Other Pre-specified|Mean Change From Baseline in WPAI at Week 52|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387269|NCT01383421|Other Pre-specified|Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387270|NCT01383421|Other Pre-specified|Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of >1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.~A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.|||percentage of participants|||Number
1387271|NCT01383421|Other Pre-specified|Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.~A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.|||percentage of participants|||Number
1387272|NCT01383421|Other Pre-specified|Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78|"ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments:~Patient's assessment of pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~HAQ-DI~Acute phase reactant value (CRP or erythrocyte sedimentation date [ESR])"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.|||percentage of participants|||Number
1387273|NCT01383421|Other Pre-specified|Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|Baseline, Weeks 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387274|NCT01383421|Other Pre-specified|Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78|The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|Baseline, Weeks 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387275|NCT01383421|Other Pre-specified|Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78|The DAS28 is a validated combined index of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity.|Baseline and Weeks 24, 52, 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
1387276|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 64|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
1387277|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
1387278|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 36|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
1387279|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
1387280|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 12|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
1387281|NCT01383421|Primary|Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants|||Number
1387282|NCT01383356|Secondary|Area Under the Curve 0 to Inf (AUC0-inf)|AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period|||ng*h/ml||Standard Deviation|Mean
1387284|NCT01383356|Primary|Maximum Plasma Concentration (Cmax)|Maximum measured concentration of metformin in plasma, per period.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period.|||ng/ml||Standard Deviation|Mean
1387286|NCT01383317|Secondary|Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo|Participants were questioned to see if they knew what interventional group they belonged to.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||Participants|||Count of Participants
1387287|NCT01383317|Secondary|Leg Pain at 48 Hours|Number of participants that had leg pain at 48 hours.|postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||Participants|||Count of Participants
1387288|NCT01383317|Secondary|McGill Pain Sensory|The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience. The scale range is 0-78, with higher scores denoting worse outcomes.|Postoperative day 1 and postoperative day 2|Population differs from participant flow, because some participants in each group did not complete the assessment.|||units on a scale||Standard Deviation|Mean
1387289|NCT01383317|Secondary|Level of Sedation|The Ramsey Sedation Scale (RSS) was used to determine the level of sedation. Th RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive. The score range is from 1-6, with higher scores denoting worse outcomes.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||units on a scale||Standard Deviation|Mean
1387290|NCT01383317|Secondary|Use of Antiemetics|Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||Participants|||Count of Participants
1387291|NCT01383317|Secondary|Consumption of Nonopioid Analgesics|All non-opioids analgesics administered during postoperative day 1 and 2 will be recorded and the number of participants that used nonopiods will be given.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.|||Participants|||Count of Participants
1387292|NCT01383317|Secondary|Number of Participants That Consumed Opioids|All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.|||Participants|||Count of Participants
1387293|NCT01383317|Primary|Comparison of Pain Intensity and Unpleasantness Postoperatively|Pain intensity and unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.|Postoperative day 1 and postoperative day 2|Data was only collected for participants that were alert and conscious.|||units on a scale||Standard Deviation|Mean
1387294|NCT01383213|Secondary|to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality|"The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of:~CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint~Control: patients randomised to Venturi mask treatment~Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP"|participants will be followed for the duration of hospital stay, an expected average of 4 weeks|||||||
1387295|NCT01383213|Primary|to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation.|"Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2<90%;Exhaustion.~The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician."|the reaching of the following endotracheal intubation criteria maintained for at least one hour:||||participants|||Number
1387296|NCT01383200|Primary|Participants Score on Pain Scale|Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort|1 hour (60minutes) post LASIK operation|Five participants received tetracaine right eye and lidocaine left eye and six participants received lidocaine right eye and tetracaine left eye. A total of 22 eyes were analyzed for pain.|||Score on scale|eyes|Standard Deviation|Mean
1387297|NCT01383174|Secondary|Breast Cancer-Specific Distress of the Intrusive Thoughts Scale|Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387298|NCT01383174|Secondary|Somatization a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1388111|NCT01375751|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C data at Week 12 were imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1387299|NCT01383174|Secondary|Depression a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387300|NCT01383174|Primary|Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0–108. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387301|NCT01383174|Primary|Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to Enjoyment of Life. Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0–16. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387302|NCT01383174|Primary|Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0–28. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387303|NCT01383174|Primary|Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0–20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387304|NCT01383174|Primary|Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0–20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387305|NCT01383174|Secondary|Anxiety a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387306|NCT01383174|Primary|Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer–specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social–family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0–24. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
1387307|NCT01383161|Secondary|Change From Baseline to 18 Months on Beck Depression Inventory (BDI)|Beck Depression Inventory is a self-reported questionnaire consisting of 21 items that assess for core depressive symptoms, including sadness, sleep, suicidality, and anhedonia. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (no depressive symptoms) to 84 (extreme depression), with higher scores indicating more significant depression.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
1387308|NCT01383161|Secondary|Change From Baseline to 18 Months on Trail Making Test, Part A|Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a circle from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Respondents were allotted as much time as necessary to complete the task. Higher scores indicate greater impairment.|Baseline and 18 Months||||seconds||Standard Deviation|Mean
1387309|NCT01383161|Primary|Change From Baseline on Buschke Selective Reminding Task, Total Score|Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Total Recall score is the sum of words recalled over the 12 trials, which reﬂects immediate recall (short-term memory) for new information. Scores range from 0 to 144, with higher scores indicating better learning.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
1387310|NCT01383161|Primary|Change From Baseline on Buschke Selective Reminding Task, Consistent Long-Term Retrieval|Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
1387311|NCT01383161|Primary|Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Delay|The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Delayed recall measures standard scoring of designs for accuracy and correct placement after delay period. Scores range from 0 to 12 and reflect recent, long-term learning, with higher scores indicating better learning. There are 6 equivalent alternate forms.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
1387312|NCT01383161|Primary|Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Recall|The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Recall measures standard scoring of designs for accuracy and correct placement across the three trials. Scores across the three trials are summed and range from 0 to 36, with higher scores indicating better learning. There are 6 equivalent alternate forms.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
1387313|NCT01383096|Primary|OZ439 t1/2|Apparent terminal half life (t1/2)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
1387314|NCT01383096|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1387315|NCT01383096|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1387339|NCT01382719|Secondary|Desire Domain From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
1388112|NCT01375660|Secondary|Incident Diabetes||12 Months||||participants|||Number
1387316|NCT01383005|Secondary|Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies|Adherence to LPV/r QD therapy (overall study population of QD-KAPITAL) compared with that of LPV/r BID therapy using data of Cohort 2 from a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. (A full comparison of the adherence between the QD-KAPITAL study and the KAPITAL2 study could not be made due to formal differences in the applied adherence questionnaires; therefore, the above in-common specified item was compared.) Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data.|||percentage of participants|||Number
1387317|NCT01383005|Secondary|Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies|Participants' perceptions of the QD and BID LPV/r regimens using data from the overall study population of QD-KAPITAL and from Cohort 2 of a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data. n=the number of participants with data for given dimension.|||units on a scale||Standard Deviation|Mean
1387318|NCT01383005|Secondary|Mean Number of Days on LPV/r QD|This independent variable was correlated with the percentage of participants with the dependent variable of an HIVTSQ Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analysis for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension|||days||Standard Deviation|Mean
1387319|NCT01383005|Secondary|Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)|Viral load change was categorized as either 'detectable to undetectable,' 'undetectable to undetectable,' or 'current detectable' (includes participants whose viral load changed from undetectable to detectable and those whose viral load was detectable throughout). This independent variable was correlated with the percentage of participants with the dependent variable of a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analyses for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension|||participants|||Number
1387320|NCT01383005|Secondary|Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions. The Overall Satisfaction dimension has a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10). The mean of the individual item scores were dichotomized as 'mean score <5 (lower participant perception of LPV/r QD)' and 'mean score ≥5 (high or very high participant perception of LPV/r QD).' The dependent variable of a mean score <5 was correlated with the independent variables of viral load and time on treatment (see Outcome Measures 9 and 10), to determine the factors associated with a participant's lower perception of QD LPV/r treatment.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants|||percentage of participants|||Number
1387321|NCT01383005|Secondary|Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen|Participants’ cumulative reasons for starting or switching to a LPV/r QD regimen were tabulated via the following yes/no questions entered on the case report form by the physician: simplification (simp) as reason to change to LPV/r QD; preference (pref) of patient as reason to change to LPV/r QD; adjustment to other antiretrovirals (adjust to ARV) as reason to change to LPV/r QD; adherence as reason to change to LPV/r QD; patient’s lifestyle as reason to change to LPV/r QD; tolerability as reason to change to LPV/r QD.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants|||participants|||Number
1387322|NCT01383005|Secondary|Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)|Participants' adherence was classified according to answers for 5 of 6 items on the participant questionnaire Simplified Medication Adherence Questionnaire (SMAQ): 4 yes/no questions: Do you ever forget to take your medicines? Do you take your medicines at the instructed time? If you ever feel ill, do you stop taking the medication? Have you ever missed your medication during weekends?; plus the following: In the past week, how many times have you missed your medication? (0, 1-2, 3-5, 6-10, >10). (Please see Outcome Measure 5 for details regarding the 6th item on the SMAQ.) Perfect adherence = no dose was forgotten, medication was not skipped for any reason, and the schedule was not modified; adequate adherence = no dose was forgotten, but at least one dose was not taken at the indicated time; poor adherence = one or more doses were not taken.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.|||participants|||Number
1387323|NCT01383005|Secondary|Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)|Number of days without medication was assessed by 1 of the 6 items on the patient questionnaire Simplified Medication Adherence Questionnaire (SMAQ): How many full days have you missed your medication since your last visit? (Please see Outcome Measure 6 for details regarding the remaining 5 items on the SMAQ.)|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.|||participants|||Number
1388113|NCT01375660|Post-Hoc|Change in Glycemia||12 Months||||percentage of participants|||Number
1387324|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). The mean score per dimension was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
1387325|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). Each dimension was considered for the evaluation of the primary outcome. For each participant, each dimension score was calculated as a sum of the individual item scores.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
1387326|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The mean score per item was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
1387327|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population|Participant treatment satisfaction was measured using the HIVTSQ, which consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). Each single item was considered for the evaluation of the primary outcome.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
1387328|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - “Moderate” means mild to moderate interference with the patient’s daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.|||percentage of participants||95% Confidence Interval|Number
1387329|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion|"The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 (Mild) to Grade 5 (Death). Grade 3 AEs are Severe and Grade 4 AEs are Life-threatening, Disabling."|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.|||percentage of participants||95% Confidence Interval|Number
1387340|NCT01382719|Secondary|Satisfaction With Arousal as Measured by GAQ Question 1|"This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
1387341|NCT01382719|Secondary|Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
1387330|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - “Moderate” means mild to moderate interference with the patient’s daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
1387331|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion|"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows: - Grade 3 means Severe, indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible. - Grade 4 means Life-threatening, Disabling, based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
1387332|NCT01382940|Secondary|Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion|IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.|||percentage of participants||95% Confidence Interval|Number
1387333|NCT01382940|Secondary|Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion|A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
1387334|NCT01382940|Primary|Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion|"The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). Incidence is defined as the percentage of participants experiencing an IRR."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
1387335|NCT01382901|Primary|International Restless Legs Syndrome (IRLS) Total Score|The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.|Change from Baseline to Day 28|Evaluable Population|||Scores on a scale||Standard Deviation|Mean
1387336|NCT01382719|Secondary|FSDS–DAO Total Score|"FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, How often do you feel: Distressed about your sex life and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
1387337|NCT01382719|Secondary|Quality of Relationship With Partner as Measured by GAQ Question 4|"This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
1387338|NCT01382719|Secondary|Satisfaction With Desire as Measured by GAQ Question 2|"This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
1387342|NCT01382719|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)|"The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = Yes minus the number of baseline events with FSEP-R Q10 = Yes. Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.||||SSEs||Standard Deviation|Mean
1387343|NCT01382602|Primary|Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months|A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.|12 months|Analysis population is based on subjects that received at least 1 treatment of AMDC-USR or placebo at the 12 months follow-up..|||Percentage of subjects||95% Confidence Interval|Number
1387344|NCT01382446|Primary|Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients|Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol.|18 Months|Intention to Treat Analysis Used|||participants|||Number
1387345|NCT01382303|Secondary|Mean Change of TNF-a|changes in TNF-a from baseline to 24 weeks|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
1387346|NCT01382303|Secondary|Mean Change of Fasting Glucose|changes serum fasting glucose from baseline to 24 weeks|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
1387347|NCT01382303|Secondary|Mean Change of Creatinine|changes serum creatinine from baseline to 24 weeks|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
1387348|NCT01382303|Secondary|Mean Change of eGFR|changes in eGFR from baseline to 24 weeks|baseline and 24 weeks||||ml/min per 1.73m2||Standard Deviation|Mean
1387349|NCT01382303|Secondary|Percentage Change in Albuminuria|Changes of urine albumin to creatinie ratio from baseline to 24 weeks|baseline and 24 weeks||||% change from baseline||Inter-Quartile Range|Mean
1387350|NCT01382303|Primary|Percentage Change in Proteinuia|Changes of urine protein to creatinie ratio from baseline to 24 weeks|baseline and 24 weeks||||% change from baseline||Inter-Quartile Range|Mean
1387351|NCT01382251|Secondary|Brief Pain Inventory (BPI) Functional Interference Score.|Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for “does not interfere” and 10 for “completely interferes.” The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
1387352|NCT01382251|Secondary|Short Form 12|A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
1387353|NCT01382251|Secondary|Zarit Burden Interview (ZBI)|"A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for never and 4 for nearly always. Scores range from 0-88 with higher scores indicating increased burden of care."|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
1387354|NCT01382251|Primary|Functional Autonomy Measurement System (SMAF)|29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
1387355|NCT01382225|Secondary|Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating|"The subject was asked on a questionnaire, Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life, and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement."|Baseline, Up to Day 14|Modified Intent-to-Treat|||Percentage of Participants|||Number
1387356|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score|For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percentage change||Standard Deviation|Mean
1387357|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score|The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percent change||Standard Deviation|Mean
1387358|NCT01382225|Secondary|Percentage Change From Baseline in Schirmer I Score|The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percent change||Standard Deviation|Mean
1388739|NCT01369706|Primary|Electromagnetic Interference|inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function|time during exposure to hand-held metal detector (2x 30 sec)|Electromagnetic interference|||participants|||Number
1387359|NCT01382225|Secondary|Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score|The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percent change||Standard Deviation|Mean
1387360|NCT01382225|Secondary|Change From Baseline in GSF Total Score at Day 14|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat|||Units on a scale||Standard Deviation|Mean
1387361|NCT01382225|Secondary|Change From Baseline in LGS Total Score at Day 14|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat|||Units on a scale||Standard Deviation|Mean
1387362|NCT01382225|Primary|Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat|||Units on a scale||Standard Deviation|Mean
1387363|NCT01382225|Primary|Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat (mITT): The set of all randomized subjects who received at least one administration of the allocated product, had baseline efficacy measurement, had at least 1 post-baseline measurement and received the correct formulation of the lissamine green solution.|||Units on a scale||Standard Deviation|Mean
1387364|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Physical Examination Findings||Baseline (Day 1) and Final Visit (up to Week 12)|All-treated data set|||participants|||Number
1387365|NCT01382212|Secondary|Oral Body Temperature: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||degrees Celsius||Standard Deviation|Mean
1387366|NCT01382212|Secondary|Heart Rate: Mean Change From Baseline to Final Visit|Heart rate was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||bpm||Standard Deviation|Mean
1387367|NCT01382212|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit|Blood pressure was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||mm Hg||Standard Deviation|Mean
1387368|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings|12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.|Baseline (Day 1) to Final Visit (up to Week 12)|All-treated data set|||participants|||Number
1387369|NCT01382212|Secondary|Number of Subjects With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).|All-treated data set|||participants|||Number
1387370|NCT01382212|Secondary|Osteocalcin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||ng/mL||Standard Deviation|Mean
1387371|NCT01382212|Secondary|Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||pg/mL||Standard Deviation|Mean
1387372|NCT01382212|Secondary|Total Protein and Albumin: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||g/dL||Standard Deviation|Mean
1387373|NCT01382212|Secondary|Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||mEq/L||Standard Deviation|Mean
1387374|NCT01382212|Secondary|Alkaline Phosphatase: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||IU/L||Standard Deviation|Mean
1403151|NCT01236196|Primary|Depressive Symptoms|Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1387375|NCT01382212|Secondary|Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||mg/dL||Standard Deviation|Mean
1387376|NCT01382212|Secondary|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||U/L||Standard Deviation|Mean
1387377|NCT01382212|Secondary|Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||cells x 10^9/µL||Standard Deviation|Mean
1387378|NCT01382212|Secondary|White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||cells x 10^3/µL||Standard Deviation|Mean
1387379|NCT01382212|Secondary|Red Blood Cells: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||cells x 10^6/µL||Standard Deviation|Mean
1387380|NCT01382212|Secondary|Hematocrit: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||percent||Standard Deviation|Mean
1387381|NCT01382212|Secondary|Hemoglobin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||g/dL||Standard Deviation|Mean
1387382|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set|||percentage of participants||95% Confidence Interval|Number
1387383|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set|||percentage of participants||95% Confidence Interval|Number
1387384|NCT01382212|Primary|Percentage of Subjects With Hypercalcemia|The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).|Day 1 to Week 12|All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol|||percentage of participants||95% Confidence Interval|Number
1387385|NCT01382186|Primary|Veteran Need for Education Support for My HealtheVet and Secure Messaging Use.|Veterans were asked to report if they would like to have education and support using My HealtheVet and the Secure Messaging tool.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
1387386|NCT01382186|Primary|Veterans That Believed Improvements to the Secure Messaging System Would Make the Tool More Useful in the Future Are Presented in the Table.|Veterans were asked to report if improvements to the secure messaging system would make the tool more useful for use in the future.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
1387387|NCT01382186|Primary|Intention to Use Secure Messaging in the Future|Veteran respondent intention to use Secure Messaging in the future|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
1387388|NCT01382186|Primary|Benefits of Using Secure Messaging|Veterans report benefits of using Secure Messaging|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
1387389|NCT01382186|Primary|Reasons for Using Secure Messaging Tool on My HealtheVet|Participants reported reasons for Using Secure Messaging tool on My HealtheVet|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
1387390|NCT01382186|Primary|Frequency of Electronic Resource Use|Mail surveys examine Veterans frequency of electronic resource use.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans. The purposive sample of 33 Veterans from phase 1 was not included in this method of the study.|||participants|||Number
1387391|NCT01382186|Primary|Secure Messaging Use and Content Patterns|Extraction of secure messages over a three-month time frame to examine message content type, including: general, tests, medication, and appointments.|3 months|This method of secondary data collection was conducted with the purposive sample of 33 Veterans in phase 1 of the study. The random sample of 819 Veteran survey respondents in phase 2 were not included in this method of data collection.|||secure messages|Participants||Number
1387404|NCT01381900|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Pecent change||Standard Error|Least Squares Mean
1387392|NCT01382186|Primary|Usability of Secure Messaging|To determine ease of use and usefulness of secure messaging. Purposive sample of 33 participants were assessed for their ability to complete the following tasks: navigate to Secure Messaging, log-in to My HealtheVet and Secure Messaging, Set user preferences, check Secure Message inbox, open and send Secure Message, Open and read Secure Message attachment. Measured as: (1) able to complete task; (2) able to complete task with some difficulty; (3) not able to complete task.|baseline|This user-testing method was conducted with the first purposive sample of 33 participants in phase 1 of the study. The random sample of 819 participants in phase 2 were not a part of the user-testing study method.|||participants|||Number
1387393|NCT01382108|Primary|Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.|Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.||||mm||Standard Deviation|Mean
1387394|NCT01382108|Primary|Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.|Measurements will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.||||seconds||Standard Deviation|Mean
1387395|NCT01382108|Primary|Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6)|"Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.~The meibomium gland dropout score subjective grading scale:~0 = no loss of mebomium glands~= area of meibomium gland loss less than 33%~= area of meibomium gland loss between 33% and 67%~= area of meibomium gland loss more than 67%."|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.||||units on a scale||Standard Deviation|Mean
1387396|NCT01381952|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)|||percentage of dose reduction||Standard Deviation|Mean
1387397|NCT01381952|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)|||percentage of dose reduction||Standard Deviation|Mean
1387398|NCT01381952|Primary|Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.|"The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics.~A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA."|1 day||||Scores on a scale||95% Confidence Interval|Mean
1387399|NCT01381926|Primary|Determine Changes in Bone Turnover Markers by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone turnover by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.|Baseline to 20 weeks|For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.|||U/L||Standard Deviation|Mean
1387400|NCT01381926|Primary|Determine Changes in Bone Turnover Markers by Serum N-Telo Peptide During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone turnover by Serum N-Telo peptide (NTX) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated|Baseline to 20 weeks|For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.|||nMBCE/L||Standard Deviation|Mean
1387401|NCT01381926|Primary|Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone reabsorption by bone-specific alkaline phosphatase (BAP) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.|Baseline to 20 weeks|For Crossover study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.|||mg/L||Standard Deviation|Mean
1387402|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18|The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Percentage of patients|||Number
1387403|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Percentage of patients|||Number
1387405|NCT01381900|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1387406|NCT01381900|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of double-blind study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1387407|NCT01381874|Secondary|Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment|Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment.|Baseline and End of treatment (approximately 2 years)|"ITT analysis set with valid baseline value and at least 1 post baseline value. Here n (number analyzed) signifies participants evaluable for specified categories."|||Nanomoles Per Liter (nmol/L)||Standard Deviation|Mean
1387408|NCT01381874|Secondary|Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment|Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment.|Baseline and End of treatment (approximately 2 years)|"ITT analysis set with valid baseline value and at least 1 post baseline value. Here n (number analyzed) signifies participants evaluable for specified categories."|||Picomoles Per Liter (Pmol/L)||Standard Deviation|Mean
1387409|NCT01381874|Secondary|Duration of Response|Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria.|Approximately 2 years|ITT analysis set with measurable disease at baseline with complete or partial response.|||months||95% Confidence Interval|Median
1387410|NCT01381874|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Approximately 2 years|ITT analysis set with measurable disease at baseline.|||Percentage of participants|||Number
1387411|NCT01381874|Secondary|Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Approximately 2 years|ITT analysis set with measurable disease at baseline.|||Percentage of participants|||Number
1387412|NCT01381874|Primary|Overall Survival (OS)|OS was calculated as the time from randomization to death from any cause.|Approximately 3 years|ITT analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
1387413|NCT01381874|Primary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system.|Approximately 2 years|Intent-to-Treat (ITT) analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
1387414|NCT01381679|Secondary|Change From Baseline in TG at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.|||mg/dL||95% Confidence Interval|Mean
1387415|NCT01381679|Secondary|Change From Baseline in Triglycerides (TG) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.|||mg/dL||95% Confidence Interval|Mean
1387416|NCT01381679|Secondary|Change From Baseline in HDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.|||mg/dL||95% Confidence Interval|Mean
1387417|NCT01381679|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.|||mg/dL||95% Confidence Interval|Mean
1387418|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.|||mg/dL||95% Confidence Interval|Mean
1387419|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.|||mg/dL||95% Confidence Interval|Mean
1387420|NCT01381679|Secondary|Change From Baseline in TC at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.|||mg/dL||95% Confidence Interval|Mean
1387421|NCT01381679|Secondary|Change From Baseline in Total Cholesterol (TC) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.|||mg/dL||95% Confidence Interval|Mean
1403384|NCT01235338|Primary|Cmax of o-Desmethylvenlafaxine|Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.|Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
1387422|NCT01381679|Primary|Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level|Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively|Up to 12 months||||Participants|||Number
1387423|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])|Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1387424|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titres (by Pseudovirion-Based Neutralisation Assay [PBNA])|Antibody titers were given as Geometric mean titers (GMTs). The cut-off of the assay were ≥ 40 ED50 for anti-HPV-16 and anti-HPV-18.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1387425|NCT01381575|Secondary|Number of Subjects Completing the Vaccination Course|The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.|Up to Month 13|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.|||Subjects|||Number
1387426|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response|"The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.~For this group, results were only made available one month after the last vaccine dose, at Month 13."|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||cells/million B-cells||Inter-Quartile Range|Median
1387427|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||cells/million T-cells||Inter-Quartile Range|Median
1387428|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination and B-cell pre-vaccination status.|||cells/million B-cells||Inter-Quartile Range|Median
1387429|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B Cell-mediated Immune Response|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||cells/million B-cells||Inter-Quartile Range|Median
1387430|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)|The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 7 EL.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||cells/million T-cells||Inter-Quartile Range|Median
1389182|NCT01364740|Other Pre-specified|Attitude Toward Device Use Questionnaire Scores|Questionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores|one night||||units on a scale||Standard Deviation|Mean
1387431|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)|The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination.|At Months 0, 13, 18 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||cells/million T cells||Inter-Quartile Range|Median
1387432|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T Cell-mediated Immune Response (CMI)|"The CMI response was the measure of the cytokines production [IL-2, IFN-γ, TNF-α and CD40L] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-18. The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells.~All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titer lower than the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titer ≥ 7 EL.U/mL) prior to vaccination."|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||cells/million T cells||Inter-Quartile Range|Median
1387433|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI)|"The CMI response was the measure of the cytokines production [i.e.interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16 The frequency was presented as number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells.~All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody titre lower than the cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody titre ≥ 8 El.U/mL) prior to vaccination."|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||cells/million T cells||Inter-Quartile Range|Median
1387434|NCT01381575|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|"Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.~Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination."|From Day 0 up to Months 7, 13, 18, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.|||Subjects|||Number
1387435|NCT01381575|Secondary|Number of Subjects With Pregnancies Ongoing and Their Outcome|Specific pregnancy outcomes were elective termination with apparent congenital anomaly and ectopic pregnancy.|From Day 0 up to Months 7, 13, 24 and 36|The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.|||Subjects|||Number
1387436|NCT01381575|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 to Months 7, 13, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.|||Subjects|||Number
1387437|NCT01381575|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|"pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Note: Results up to Months 24 and 36 will be updated once they become available."|From Day 0 up to Months 7, 13, 18, 24 and 36|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.|||Subjects|||Number
1387438|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = Unsolicited AE preventing normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the study vaccination.|During the 30-day (Days 0-29) post vaccination period|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available.|||Subjects|||Number
1389183|NCT01364740|Secondary|Oxygen Saturation|Mean oxygen saturation|One night||||percent||Standard Deviation|Mean
1403385|NCT01235338|Secondary|Diastolic Blood Pressure||Baseline and up to 39 days|SAS|||mmHg||Standard Deviation|Mean
1387439|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = Occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Fever > 39.0 °C. Related = General symptom assessed by the investigator as causally related to the vaccination.|During the 7-day period (Days 0-6) following any vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.|||Subjects|||Number
1387440|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-16 and ≥ 7 EL.U/mL for HPV-18.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1387441|NCT01381575|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = Significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = Redness/swelling above 50 millimeters (mm).|During the 7-day period (Days 0-6) following any vaccination|The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects, i.e. subjects who received at least one dose of vaccine in this study, for whom data were available and symptom sheet completed.|||Subjects|||Number
1387442|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1387443|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were expressed as geometric mean titers (GMTs) and given in EL.U/mL, with the cut-off values of ≥ 8 ELISA units per millilitre (EL.U/mL) for HPV-016 and ≥ 7 EL.U/mL for HPV-018|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1387444|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Months 0, 13, 18, 24 and 36|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1387445|NCT01381575|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA).|Antibody concentrations were and expressed as geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay [ELISA] units per millilitre (EL.U/mL), with the cut-off values of 8 EL.U/mL for HPV-016 and 7 EL.U/mL for HPV-018.|1 month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1387446|NCT01381575|Primary|Number of Subjects Seroconverted for Anti- Human Papilloma Virus 16 (Anti-HPV-16) and Anti-Human Papilloma Virus 18 (Anti-HPV-18) Antibodies|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 titres ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|1 month after the last dose of study vaccine (Month 7)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with available data concerning immunogenicity outcome measures and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1387447|NCT01381562|Secondary|Tmax of GSK2251052 Using Intensive PK Sampling|Tmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387448|NCT01381562|Secondary|AUC of GSK2251052 Using Intensive PK Sampling|AUC was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387449|NCT01381562|Secondary|Cmax of GSK2251052 Using Intensive PK Sampling|Cmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387450|NCT01381562|Secondary|Tmax of GSK2251052 Using Non-intensive PK Sampling|Tmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387451|NCT01381562|Secondary|AUC of GSK2251052 Using Non-intensive PK Sampling|AUC was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387452|NCT01381562|Secondary|Cmax of GSK2251052 Using Non-intensive PK Sampling|Cmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387453|NCT01381562|Secondary|Time to Cmax (Tmax) of GSK2251052|Tmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387454|NCT01381562|Secondary|Area Under the Concentration Time Curve (AUC) of GSK2251052|AUC was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
1387455|NCT01381562|Secondary|Maximum Plasma Concentration (Cmax) of GSK2251052|Cmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for pharmacokinetics (PK) analysis was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population consisted of participants for whom PK samples were collected. Data for PK analysis was not collected.||||||
1387456|NCT01381562|Secondary|Number of Participants With Therapeutic Response in MITT Population|Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. Therapeutic response was determined programmatically.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|MITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1387457|NCT01381562|Secondary|Number of Participants With Therapeutic Response in Microbiological Evaluable Population|Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. Therapeutic response was determined programmatically.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|Microbiological evaluable population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1387458|NCT01381562|Secondary|Number of Participants With Clinical Response in MITT Population|Clinical success was defined as resolution or improvement of Baseline signs and symptoms of cIAI, including white blood cell count within normal limits, participant was afebrile and peritoneal findings consistent with cIAI were no longer present with no new symptoms present that were not present at Baseline and no use of additional or alternate antibiotic therapy. Clinical failure was defined as (1) Lack of improvement or worsening in one or more signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or (2) signs and symptoms recorded that were not present at Baseline, or (3) receipt of additional or alternate antibiotic therapy for cIAI or (4) participant had died, or (5) participant had an adverse event leading to study drug discontinuation and the participant required additional or alternative antibacterial therapy for the current cIAI.|End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1387468|NCT01381562|Primary|Number of Participants With Clinically Significant Trends in Vital Signs Over the Period of Study Duration|Vital parameters including systolic and diastolic blood pressure, heart rate, respiration rate, and temperature were recorded. The number of participants with potentially clinically concern value of any vital parameter at any visit were reported.|Up to Day 42|Safety Population.|||Participants|||Count of Participants
1387483|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Hematology parameters included hemoglobin and MCHC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hemoglobin and MCHC are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
1387459|NCT01381562|Secondary|Number of Participants With Clinical Response in Microbiological Evaluable Population|Clinical success was defined as resolution or improvement of Baseline signs and symptoms of cIAI, including white blood cell count within normal limits, participant was afebrile and peritoneal findings consistent with cIAI were no longer present with no new symptoms present that were not present at Baseline and no use of additional or alternate antibiotic therapy. Clinical failure was defined as (1) Lack of improvement or worsening in one or more signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or (2) signs and symptoms recorded that were not present at Baseline, or (3) receipt of additional or alternate antibiotic therapy for cIAI or (4) participant had died, or (5) participant had an adverse event leading to study drug discontinuation and the participant required additional or alternative antibacterial therapy for the current cIAI.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|Microbiological evaluable population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1387460|NCT01381562|Secondary|Number of Participants With Microbiological Response in Microbiological Evaluable Population|Microbiological Response at End of IV Therapy was assessed as MS or MF. MS was categorized as ME and PME. MF was categorized as MP and PMP, unable to determine, new infection and colonization. Number of participants with microbiological response in microbiological evaluable population were reported.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|Microbiological evaluable population. Only those participants available at the specified time points were analyzed|||Participants|||Count of Participants
1387461|NCT01381562|Secondary|Number of Participants With Microbiological Response in MITT Population|Microbiological Response at End of IV Therapy was assessed as Microbiological Success (MS) or Microbiological Failure (MF). MS was categorized as microbiological eradication (ME) and presumed microbiological eradication (PME). MF was categorized as microbiological persistence (MP), presumed microbiological persistence (PMP), unable to determine, new infection and colonization. Number of participants with microbiological response in MITT population were reported.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|MITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1387462|NCT01381562|Secondary|Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Evaluable Population.|Test of cure-clinical success was resolution of signs and symptoms of complicated intra-abdominal infection (cIAI) for participants who were clinical successes at the end of IV therapy visit with no new symptoms recorded that were not present at Baseline and no use of additional antibiotic therapy for cIAI. Test of cure-clinical failure was persistence of signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or new signs and symptoms recorded that were not present at a previous visit, or receipt of additional or alternate antibiotic therapy for cIAI or participant had died. Test of cure- unable to determine was refusal to consent to a clinical examination, lost to follow-up. Participants who were 'unable to determine' at End of IV therapy were considered 'unable to determine' Test of cure Visit as well. Due to early termination of the study, a Bayesian approach for informal hypothesis testing was not performed.|Day 5 to 9 post IV therapy|Microbial evaluation population comprised of participants from the MITT population who adhered to the protocol (do not violate the protocol) and received at least 5 days of IV therapy.|||Participants|||Count of Participants
1387463|NCT01381562|Primary|Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Intent to Treat (MITT) Population|Test of cure-clinical success was resolution of signs and symptoms of complicated intra-abdominal infection (cIAI) for participants who were clinical successes at the end of IV therapy visit with no new symptoms recorded that were not present at Baseline and no use of additional antibiotic therapy for cIAI. Test of cure-clinical failure was persistence of signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or new signs and symptoms recorded that were not present at a previous visit, or receipt of additional or alternate antibiotic therapy for cIAI or participant had died. Test of cure- unable to determine was refusal to consent to a clinical examination, lost to follow-up. Participants who were 'unable to determine' at End of IV therapy were considered 'unable to determine' Test of cure Visit as well. Due to early termination of the study, a Bayesian approach for informal hypothesis testing was not performed.|Day 5 to 9 post IV therapy|MITT Population comprised of all randomized participants who received at least one dose of study medication and had at least one Gram-negative pathogen identified at Baseline. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1387464|NCT01381562|Primary|Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop|Participants in whom the hemoglobin level dropped by more than 30% from Baseline that was not attributable to acute blood loss were recorded and immediately withdrawn from study treatment. Baseline assessments were recorded on Visit 1 (Day 1) and used as Baseline values. The change from Baseline was calculated by subtracting the Baseline values from Day 42 values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing. The mean change from Baseline in hemoglobin for participants with significant hemoglobin drop were reported.|Baseline (Day 1) and up to Day 42|Safety Population. Only those participants available at the specified time points were analyzed.|||grams/L||Standard Deviation|Mean
1387465|NCT01381562|Primary|Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration|Absolute mean reticulocytes values recorded over the period of duration were reported.|Up to 42 days|Safety population.|||Trillion cells per Litre||Standard Deviation|Mean
1387466|NCT01381562|Primary|Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration|Absolute mean hemoglobin values recorded over the period of duration were reported.|Up to Day 42|Safety population.|||Gram per Litre||Standard Deviation|Mean
1387467|NCT01381562|Primary|Number of Participants With Normal and Abnormal ECG Findings|12-lead ECGs was obtained during the study using an ECG machine and performed with the participant in a semi-supine position rested in this position for at least 10 minutes beforehand. Measurements deviated substantially from previous readings were repeated immediately. Number of participants with normal and abnormal ECG findings were reported.|Up to Day 42|Safety population.|||Participants|||Count of Participants
1387469|NCT01381562|Primary|Number of Participants With Any Adverse Event|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE included AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition|Up to Day 42|Safety Population comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1387470|NCT01381549|Secondary|Tmax of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|||||||
1387471|NCT01381549|Secondary|AUC of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|||||||
1387472|NCT01381549|Secondary|Cmax of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|||||||
1387473|NCT01381549|Secondary|Tmax of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
1387474|NCT01381549|Secondary|AUC of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
1387475|NCT01381549|Secondary|Cmax of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
1387476|NCT01381549|Secondary|Time to Cmax (Tmax) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
1387477|NCT01381549|Secondary|Area Under the Concentration Time Curve (AUC) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
1387478|NCT01381549|Secondary|Maximum Plasma Concentration (Cmax) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
1387479|NCT01381549|Secondary|Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit|The therapeutic response was the combination of a participant’s clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.|End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.|||Participants|||Count of Participants
1387480|NCT01381549|Secondary|Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit|Clinical response was a combination of clinical success and clinical failure. In clinical success, participants showed no signs and symptoms of pyelonephritis and lower complicated urinary tract infection and antibiotics are not used for the same. In clinical failure, there is reappearance of signs and symptoms of and lower complicated urinary tract infection and participant required antibiotics for the same.|End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.|||Participants|||Count of Participants
1387481|NCT01381549|Secondary|Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit|Microbiological response involved both microbiological success and microbiological failure. A reduction in the uropathogens in the urine culture and no growth on blood culture was termed as microbiological success. Increase in the uropathogens in the urine culture and pathogens identified in the blood culture or use of antibacterials other than study treatments were classified as microbiological failures.|End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.|||Participants|||Count of Participants
1387482|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gigacells per Liter||Standard Deviation|Mean
1387484|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes|Hematology parameters included RBC count and reticulocytes. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in RBC count and reticulocytes are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
1387485|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)|Hematology parameters included MCV. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCV are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
1387486|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)|Hematology parameters included MCH. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCH are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
1387487|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Hematocrit|Hematology parameters included hematocrit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hematocrit are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
1387488|NCT01381549|Primary|Therapeutic Response at the Test of Cure Visit|The therapeutic response was the combination of a participant’s clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.|Test of Cure Visit (5 to 9 days post-IV therapy)|Microbiological Intent to Treat (MITT) comprised of all randomized participants who received at least one dose of study medication and had at least one gram-negative uropathogen and no more than two gram-negative uropathogens (≥10^5 Colony forming units [CFU]/mL for each pathogen) identified from Baseline urine culture.|||Participants|||Count of Participants
1387489|NCT01381549|Primary|Summary of Vital Signs- Mean Temperature|Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF).|Up to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Celsius||Standard Deviation|Mean
1387490|NCT01381549|Primary|Summary of Vital Signs- Mean Respiration Rate|Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths/minute||Standard Deviation|Mean
1387491|NCT01381549|Primary|Summary of Vital Signs- Mean Heart Rate|Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1387492|NCT01381549|Primary|Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented.|Up to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1387493|NCT01381549|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve lead ECGs were obtained during the study using an ECG machine that automatically measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Twelve lead ECGs were performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Measurements that deviated substantially from previous readings were repeated immediately. Three measurements were taken at pre-dose on Day 1 at least 5 min apart. One additional ECG measurement was taken after completion of the first infusion of study medication. Two ECG measurements (pre and post-1st infusion of the day) were taken on Day 4 while the participant was on IV therapy. When there was an abnormal finding, two more were taken and the mean PR interval, QRS duration, QT interval and QTcB were calculated from automated ECG readings. One ECG measurement was taken at the early safety follow-up visit.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1387494|NCT01381549|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 28 days post-therapy|Safety Population.|||Participants|||Count of Participants
1387495|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)|Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||International units per Liter||Standard Deviation|Mean
1387496|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole per Liter||Standard Deviation|Mean
1387497|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin|Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Micromole per liter||Standard Deviation|Mean
1387498|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)|Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliliter per minute||Standard Deviation|Mean
1387499|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein|Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population which comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
1387500|NCT01381471|Primary|Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period|The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)|||healthcare encounters||Standard Deviation|Mean
1387501|NCT01381471|Primary|Mean Number of Pharmacy Claims by Participants During the Post-Index Period|The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)|||pharmacy claims||Standard Deviation|Mean
1387502|NCT01381406|Secondary|Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years|Unadjusted incidence rates per 100 person years of chronic obstructive pulmonary disease (COPD)-related hospitalizations and emergency department visits by treatment group are presented. Incidence rate is calculated by dividing the number of healthcare service encounters by the number of person years of follow up. Person years adjust for different lengths of follow up for individual participants|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.|||visits per 100 person years|||Number
1387503|NCT01381406|Secondary|Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group|The mean costs of health care encounters adjusted to control for baseline differences between treatment groups and reported in 2008 United States dollars as calculated with the consumer price index (CPI) are presented. CPI is standard multiplier for adjusting the cost of goods and services to a single year. Total costs include pharmacy and medical costs. Medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. COPD-related pharmacy costs were computed from paid amounts of COPD-related prescription medications.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.|||United States dollars||95% Confidence Interval|Mean
1387522|NCT01380769|Secondary|Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only|Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.|12 months|Intention-To-Treat (ITT)|||Percentage of Participants|||Number
1387523|NCT01380769|Primary|To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only|Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.|Up to 18 months|Intention-to-treat (ITT) and Patient Safety Population (PSP), includes all CRLX101 + BSC subjects who received at least 1 dose of study treatment and all randomized BSC alone subjects who attended at least 1 study visit. (Confidence interval if insufficient data to estimate NE = 99999.99)|||months||95% Confidence Interval|Median
1387504|NCT01381406|Primary|Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)|A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.|||exacerbations per 100 person years|||Number
1387505|NCT01381120|Secondary|Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.|Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and three months.||||units on a scale||95% Confidence Interval|Mean
1387506|NCT01381120|Primary|Change in Post-ureteroscopy Stent-induced Pain|Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and 3 months.||||units on a scale||95% Confidence Interval|Mean
1387507|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude||Post estradiol at one month||||IU/L||Standard Error|Mean
1387508|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude|The study is powered on luteinizing hormone pulse amplitude because it is the clinical outcome for which the most data is available. The primary comparison is whether there is a significant reduction in the pulse amplitude in the obese between the pre- and post-treatment periods and whether there is no change in the pulse amplitude in the normal weight patients between the pre and post-treatment periods.|Baseline||||IU/L||Standard Error|Mean
1387509|NCT01380834|Secondary|Opioid Consumption|Other secondary end points will total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used at 24 hours postoperatively (or until the patient is discharged, if sooner).|24 hrs after blocks were done or until the patient is discharged||||mg/kg||Standard Deviation|Mean
1387510|NCT01380834|Secondary|Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).|The VAS (Visual Analog Scale, 0 mm “no pain”, to 100 mm,” the worst pain possible “) is used to assess postoperative pain for patients. Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block.|24 hrs after blocks were done or until the patient is discharged||||units on a scale||Standard Deviation|Mean
1387511|NCT01380834|Primary|Opioids Consumption Via PCA|The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.|12 hrs after the blocks were done||||ng/kg/min||Standard Deviation|Mean
1387512|NCT01380782|Other Pre-specified|Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI|To explore the correlation between perfusion MRI, diffusion MRI and response to therapy.|2 years|||||||
1387513|NCT01380782|Other Pre-specified|Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells|To explore the correlation between serum angiogenic peptides, circulating endothelial cells, and circulating progenitor cells with response to therapy.|2 years|||||||
1387514|NCT01380782|Other Pre-specified|Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile|To explore the extent to which the tumor's genotype and expression profile correlate with outcome.|2 years|||||||
1387515|NCT01380782|Other Pre-specified|Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG)|To explore the efficacy of BIBF 1120 in bevacizumab-naïve and bevacizumab-treated participants with recurrent anaplastic gliomas (AG) survival was assessed at 6 months for Arm A and 3 months for Arm B.|Arm A - 6 months; Arm B - 3 months||||percentage of participants|||Number
1387516|NCT01380782|Secondary|Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial)|Safety profile in both populations - as adverse events are posted separately in detail, these results will demonstrate serious adverse events (defined as grades 3-5) that were judged at least possibly related to Nintedanib (BIBF 1120).|2 years||||number of incidents|||Number
1387517|NCT01380782|Secondary|Time-to-tumor Progression|Time-to-tumor progression in both populations.|2 years||||days||95% Confidence Interval|Median
1387518|NCT01380782|Secondary|Overall Survival|Overall survival in both populations|2 years||||months||95% Confidence Interval|Median
1387519|NCT01380782|Secondary|Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response|Best radiographic response in both populations. There were no participants with partial or complete responses, so the results are being reported in the proportion of participants who experienced stable disease (SD) as their best response (as opposed to progressive disease).|2 years||||% of patients with best response SD|||Number
1387520|NCT01380782|Primary|3-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-treated participants with recurrent GBM as measured by 3-month progression free survival (PFS3).|3 months||||percentage of participants|||Number
1387521|NCT01380782|Primary|6-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).|Six months||||percentage of participants|||Number
1387524|NCT01380743|Secondary|Duvoglustat Concentration In Skeletal Muscle|"The concentration of duvoglustat in skeletal muscle tissue homogenate was measured after pre-administration of single ascending oral doses of duvoglustat during Treatment Period 2. Participants had skeletal muscle biopsies at either Day 3 or Day 7 during Treatment Period 2.~Three participants were excluded from this analysis due to the following reasons: treatment sequence was inadvertently switched due to study site error, follow-up biopsy sample could not be conclusively identified, or muscle biopsies were mislabeled at the clinical site.~Values presented are arithmetic mean (percent coefficient of variation, [CV%]) because of the prevalence of participants with values below the limit of quantification. Concentrations below the limit of quantification were treated as zero."|Day 3 or Day 7|The Per Protocol population included all participants who successfully completed both periods.|||ng/g||Geometric Coefficient of Variation|Geometric Mean
1387525|NCT01380743|Secondary|Total GAA Activity In Skeletal Muscle|The total GAA activity in skeletal muscle was measured after a single intravenous administration of rhGAA alone and after pre-administration of single ascending oral doses of duvoglustat. Participants were assessed using skeletal muscle biopsies at either Day 3 or Day 7 during Treatment Periods 1 and 2.|Day 3 or Day 7|The Per Protocol population included all participants who successfully completed both periods.|||pmol/mg/h||Geometric Coefficient of Variation|Geometric Mean
1387526|NCT01380743|Primary|PK: AUC From Time 0 Extrapolated To Infinity (AUCinf) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The AUCinf of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2.~The number of participants analyzed for some cohorts are reduced because the terminal phase of the concentration profile for these participants was not estimable."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||h*ng/mL/h||Geometric Coefficient of Variation|Geometric Mean
1387527|NCT01380743|Primary|PK: Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Time Of The Last Measurable Concentration (AUC0-t) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The AUC0-t of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||h*ng/mL/h||Geometric Coefficient of Variation|Geometric Mean
1387528|NCT01380743|Primary|PK: Elimination Half-life (T1/2) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The T1/2 of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2.~Values presented are arithmetic mean (percent coefficient of variation, [CV%]). The number of participants analyzed for some cohorts are reduced because the terminal phase of the concentration profile for these participants was not estimable."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||h||Geometric Coefficient of Variation|Geometric Mean
1387529|NCT01380743|Primary|PK: Time To The Maximum Plasma Concentration (Tmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The Tmax of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||h||Full Range|Median
1387530|NCT01380743|Primary|Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The Cmax of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||ng/mL/h||Geometric Coefficient of Variation|Geometric Mean
1387715|NCT01379703|Secondary|Adverse Events Observed on Treatment With Lopinavir/Ritonavir.|"Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.~All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the Reported Adverse Events section of this record."|18 months||||Events|||Number
1387531|NCT01380743|Primary|Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of investigational medicinal product (IMP), or an AE with an onset date before the first dose date that worsened in severity after the first dose date. A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 up to Day 60 (includes end of study follow-up period) is reported.~A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module."|Day 1 after dosing up to Day 60|The Safety Population included all participants who were enrolled and received at least 1 dose of rhGAA or duvoglustat.|||Participants|||Count of Participants
1387532|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1387533|NCT01380730|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1387534|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1387535|NCT01380730|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1387536|NCT01380730|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
1387537|NCT01380730|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1387538|NCT01380639|Secondary|Brain Natruretic Peptide (BNP)|change in BNP from baseline to day 19|day 1, day 19|||||||
1387539|NCT01380639|Secondary|Arterial Blood Gas||day 1|||||||
1387540|NCT01380639|Secondary|Lung Function||day 1|||||||
1387541|NCT01380639|Secondary|BODE-Score|Change in Bode-Score from baseline to day 19|day 1, day 19|||||||
1387542|NCT01380639|Secondary|Isometric Maximum Handgrip Force|change in isometric max. handgrip force from baseline to day 19|day 1, day 19|||||||
1387543|NCT01380639|Secondary|Body Composition|Change in body composition from baseline to day 19|day 1 and 19|||||||
1387544|NCT01380639|Primary|6-Minute-Walking-Distance|Change in 6-minute-walking-distance from baseline to day 19|day 1, day 19||||m||Standard Deviation|Mean
1387545|NCT01380379|Secondary|Change in Assertiveness Between Baseline and Post-intervention|"Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior.~The positive change indicates an increase in assertive behavior."|Change in assertiveness from baseline to post-class (8 weeks)||||units on a scale||Standard Deviation|Mean
1387546|NCT01380379|Primary|Change in Self-efficacy From Baseline to Post-treatment|General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence.|Change in GSE from baseline to 8 weeks|The data is the change in general self efficacy from baseline to post-class, with higher scores indicating a greater increase in self-efficacy|||units on a scale||Standard Deviation|Mean
1387547|NCT01380366|Secondary|To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.|Following completion of Visit 2, study staff will obtain results of liver injury/function tests (ALT, Aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALK or ALP), GGT) from the medical record from each routine clinical exam from Month 3 through Month 24. Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.|(Visit 1) Baseline, (Visit 2) 28-31 days after baseline, then at regularly scheduled follow-up clinic visits for two years from Month 3 through Month 24||||participants|||Number
1387548|NCT01380366|Primary|To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).|Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.|(Visit 1) Baseline to (Visit 2) 28-31 days after baseline||||participants|||Number
1387549|NCT01380327|Secondary|Percent of Participants With the Occurrence of Adverse Events (AEs)|Percent of participants who experienced at least one AE.|Participant enrollment to end of study (up to 3 months post-baseline)||||Percentage of population|||Number
1387550|NCT01380327|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity Over Time|Outcome is change in mean IgE FAB activity level from baseline to post-baseline (status post 3 months of treatment). Serum from cockroach sublingual immunotherapy (SLIT)-treated participants were analyzed to determine if treatment inhibits in-vitro cockroach SLIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.(Reference: Shamji MH et al. The IgE-facilitated allergen binding (FAB) assay: validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods 2006;317(1-2): 71-9).|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Percent antibody binding||95% Confidence Interval|Mean
1387716|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed any doses of their antiretroviral treatment.|18 months|Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.|||Participants|||Number
1387551|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin subclass 4 (IgG4). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Ratio||95% Confidence Interval|Geometric Mean
1387552|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin G (IgG). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Ratio||95% Confidence Interval|Geometric Mean
1387553|NCT01380327|Primary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Ratio||95% Confidence Interval|Geometric Mean
1387554|NCT01380197|Secondary|Number of Participants Who Experienced Pain Relief||2 days||||participants|||Number
1387555|NCT01380197|Primary|Acute Chest Syndrome|Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray|3 days||||participants|||Number
1387556|NCT01380145|Secondary|Assessment of Survival and Time to Subsequent Therapy|Progression-free survival (PFS) was calculated as the date from first immunization to first observation of disease progression or death due to any cause, censored on the start date of subsequent therapy or at the last date of disease assessment for subjects without a PFS event. Overall survival (OS) was calculated as the date from first immunization to death due to any cause, censored at the date of last follow-up for subjects who were alive at the time of the analysis. Time to subsequent therapy was calculated as the date from first immunization to start of subsequent therapy for myeloma, censored at the date of death or last follow-up for subjects who did not receive subsequent therapy.|Continuously on study and for up to 5 years post-study|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.|||days||Full Range|Median
1387557|NCT01380145|Secondary|Assessment of Tumor Response|"Tumor responses were evaluated using appropriate imaging methods and were categorized according to the IMWG criteria, which includes the following response designations:~Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% plasma cells in bone marrow; Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow; Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component <100 mg/24 hrs; Partial Response (PR): ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to <200 mg/24 hrs Stable disease: not response or progression"|At 3 and 12 months after auto-SCT|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.|||participants|||Number
1387558|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Cellular Immunity|Cellular immunity was determined by enzyme-linked immunosorbent spot assay (ELISPOT) or intracellular flow cytometry to determine peripheral blood levels of interferon gamma-producing CD4+ and CD8+ T cells specific for MAGE-A3. Results were considered significant if > 50 spots and > 2 times the number of spots to negative control were observed.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.|||participants|||Number
1387559|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Humoral Immunity|Humoral immunity was determined by enzyme-linked immunosorbent assay (ELISA) to measure the presence of circulating antibodies to MAGE-A3. Titers against an antigen were considered significant if they were >100. Induction of responses was considered significant if there was a change from undetectable (<100) to detectable (>100) or if there was an at least 4-fold increase in titers over time.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.|||participants|||Number
1387560|NCT01380145|Primary|Assessment of Safety of recMAGE-A3 + AS15|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs, with severity graded according to the NCI CTCAE, Version 4.0.|Continuously for up to 14 months|The Safety Analysis Set comprises all subjects who received at least 1 immunization with study drug.|||participants|||Number
1387561|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387562|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387563|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387717|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed doses of their antiretroviral treatment.|9 months||||Participants|||Number
1387564|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387565|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387566|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387567|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387568|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||pg/mL||Standard Deviation|Mean
1387569|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs||Standard Deviation|Mean
1387570|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387571|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387572|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387573|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387574|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387575|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387576|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387577|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||pg/mL||Standard Deviation|Mean
1387578|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs||Standard Deviation|Mean
1387579|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387580|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387581|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387582|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387583|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387584|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387585|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
1387586|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1387587|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs||Standard Deviation|Mean
1387588|NCT01380093|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387589|NCT01380093|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387590|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387591|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387592|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387718|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||Participants|||Number
1387719|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|9 months||||Participants|||Number
1387593|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387594|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387595|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387596|NCT01380093|Secondary|Take Drug Again Effect at 24 Hours|Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”).|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387597|NCT01380093|Secondary|Overall Drug Liking Effect at 24 Hours|Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm= “neither like nor dislike”, and 100 mm= “strong liking”).|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387598|NCT01380093|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387599|NCT01380093|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387600|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387601|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387602|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387603|NCT01380093|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387604|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387605|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387606|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387607|NCT01380093|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387608|NCT01380093|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387609|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387610|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387611|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387612|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387613|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387614|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387735|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 6 months|Change from baseline analysis is based on participants with CD4 count results available at 6 months.|||cells per mm³||Standard Deviation|Mean
1387615|NCT01380093|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387616|NCT01380093|Secondary|Feel Sick: Peak Effect (Emax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387617|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387618|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387619|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387620|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387621|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387622|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387623|NCT01380093|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387624|NCT01380093|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387625|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-24 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387801|NCT01378520|Secondary|Change in Level of B-endorphin Immunoreactivity|Change between pre-treatment and post treatment serum levels of beta-endorphin immunoreactivity measured in pmol/L|At the end of resistance load breathing (4.5 hours after receiving the test article)||||pmol/L||Standard Deviation|Mean
1387626|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-12 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387627|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-8 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387628|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-4 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387629|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-2 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387630|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387631|NCT01380093|Secondary|Bad Effects: Time to Maximum (Peak) Effect (TEmax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387632|NCT01380093|Secondary|Bad Effects: Peak Effect (Emax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387633|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387634|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387635|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387636|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387816|NCT01378429|Secondary|Percentage of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of participants|||Number
1387637|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387638|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387639|NCT01380093|Secondary|Any Effects: Time to Maximum (Peak) Effect (TEmax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387640|NCT01380093|Secondary|Any Effects: Peak Effect (Emax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387641|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387642|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387643|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387644|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387645|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387646|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387647|NCT01380093|Secondary|Good Effects: Time to Maximum (Peak) Effect (TEmax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387817|NCT01378429|Secondary|Number of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||participants|||Number
1389184|NCT01364740|Secondary|Hypopnea Index|Number of events/hour of sleep. Hypopneas scored without EEG arousals.|One night||||events/hour||Standard Deviation|Mean
1387648|NCT01380093|Secondary|Good Effects: Peak Effect (Emax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387649|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387650|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387651|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387652|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387653|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387654|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387655|NCT01380093|Secondary|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387656|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-24 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387657|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-12 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387658|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-8 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1388772|NCT01369329|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1387659|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-4 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387660|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-1 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387661|NCT01380093|Secondary|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
1387662|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387663|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387664|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387665|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387666|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387667|NCT01380093|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387668|NCT01380093|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). Emax = Maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
1387669|NCT01380093|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2)."|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose pharmacodynamic (PD) data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
1387670|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48|Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48|From study entry to week 48||2020-12-31|12/2020||||
1387671|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48|Proportion of participants with premature discontinuation of any component of TB treatment by Week 48|From study entry to week 48||2020-12-31|12/2020||||
1387672|NCT01380080|Secondary|Proportion of Participants With Reportable Hospitalization by Week 48|Proportion of participants with any hospitalization reported by Week 48|From study entry to week 48||2020-12-31|12/2020||||
1387673|NCT01380080|Secondary|Proportion of Participants With IRIS (Using Current ACTG Definition) by Week 48|Proportion of participants with IRIS (using current ACTG definition Appendix 60) by Week 48|From study entry to week 48||2020-12-31|12/2020||||
1387674|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 That is at Least a One-grade Increase From Baseline for the Following Targeted Laboratory Values by Week 48|"Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48~The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST"|From study entry to week 48||2020-12-31|12/2020||||
1387675|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48|Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48|From study entry to week 48||2020-12-31|12/2020||||
1387676|NCT01380080|Secondary|Proportion of Participants With TB Diagnosis Per Current ACTG Diagnosis Appendix by Week 96|Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96|From study entry to week 96||2020-12-31|12/2020||||
1387677|NCT01380080|Secondary|Time to Initiation of TB Treatment by Week 96|Median time to TB treatment initiation by week 96|From study entry to week 96||2020-12-31|12/2020||||
1387678|NCT01380080|Secondary|CD4+ T-cell Count Change From Baseline|Change was calculated as the CD4+ T-cell count at week (4 and 24) minus the baseline CD4+ T-cell count. The results at week 48 will be submitted after the study is completed|From study entry to weeks 4, 24 and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||cells/ mm^3||Inter-Quartile Range|Median
1387679|NCT01380080|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm^3) at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: Participants were analyzed per original assigned randomized treatment. Missing data were assigned missing completely at random.|||cells/ mm^3||Inter-Quartile Range|Median
1387680|NCT01380080|Secondary|Proportion of Participants With HIV-1 RNA Level <400 Copies/mL|Proportion of participants with HIV-1 RNA level <400 copies/mL at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completed at random|||Proportion of participants||95% Confidence Interval|Number
1387681|NCT01380080|Secondary|Cumulative Probability of Death or AIDS Progression by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24~The result of cumulative probability of death or AIDS progression by week 48 will be submitted after the study is completed. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment|||Cumulative probablity per 100 persons||95% Confidence Interval|Number
1387682|NCT01380080|Secondary|Cumulative Probability of First AIDS Progression by Week 96|The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition|From study entry to week 96||2020-12-31|12/2020||||
1387683|NCT01380080|Secondary|Cumulative Probability of Death by Week 24|The Kaplan-Meier estimate of cumulative probability of death by week 24|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment|||Cumulative probablity per 100 persons||95% Confidence Interval|Number
1387684|NCT01380080|Primary|Cumulative Probability of Death or Unknown Vital Status by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24.~Vital status at week 48 and again at weeks 60, 72, 84, and 96 was determined for participants who do not complete study follow-up, including those who are prematurely discontinued from the study before week 24 without coming in to the clinic. Vital status for participants who are not discontinued from the study whenever a scheduled visit of any type is missed was also obtained. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment|||Cumulative probablity per 100 persons||95% Confidence Interval|Number
1387818|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine||weeks 0-6|The PP population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no IPDs.|||mcg/g||Standard Error|Least Squares Mean
1387685|NCT01379963|Secondary|Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL|Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.|||Percentage of participants|||Number
1387686|NCT01379963|Primary|Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)|Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.|||Percentage of participants|||Number
1387687|NCT01379937|Secondary|Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies|This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
1387688|NCT01379937|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies||At Days 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
1387689|NCT01379937|Secondary|Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364."|At Days 0, 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
1387690|NCT01379937|Secondary|Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease|Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1387691|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364.~This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol."|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
1387692|NCT01379937|Secondary|Mean Geometric Increase for Anti-H5N1 Antibody Titers|"MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1387693|NCT01379937|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.~Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192."|At Days 0,42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
1389185|NCT01364740|Secondary|Apnea Index|Number of events/hour of sleep|One night||||events/hour||Standard Deviation|Mean
1387694|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease|"A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
1387695|NCT01379937|Secondary|Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364."|At Days 0, 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
1387696|NCT01379937|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387697|NCT01379937|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)||During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387698|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During Day 0 to Telephone Contact (TC) Day 84 overall.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387699|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 21-day (Days 0 – 20) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387700|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature[defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more.|During a 7-day (Day 0-6) follow-up period after vaccination|The analysis was based on subjects aged 6 years or more, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387701|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on subjects aged less than 6 years, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387702|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387819|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine||weeks 0-6|The PP population. Subjects with either missing baseline data or post dose data, or both were not included in the analysis|||mcg/g||Standard Error|Least Squares Mean
1387703|NCT01379937|Secondary|H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1387704|NCT01379937|Secondary|H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1387705|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade.|From Day 0 to Day 364.|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387706|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|From Day 0 to Day 182|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1387707|NCT01379937|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Day 192.|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1387708|NCT01379781|Primary|Hamilton Rating Scales of Depression|"Assessing severity of depression; clinician rated~24 questions~13 items are scored on a 5 point scale ranging from 0=not present to 4=severe~11 items are scored from 0-2~A composite score is created by the sum of the scores from all items. Scores can range from 0-74~0-7: normal~8-13: mild depression~14-18: moderate depression~19-23: severe depression~24: very severe depression~Higher summed values indicate a greater severity of depression"|6 weeks postpartum|Those in the analysis received both baseline and 6-week assessment sessions.|||units on a scale||Standard Deviation|Mean
1387709|NCT01379768|Primary|Change From Week 1 in Relative Oxidative Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
1387710|NCT01379768|Primary|Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
1387711|NCT01379768|Primary|Change From Week 1 in Leukocyte Population at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.|||Leukocytes||Standard Deviation|Mean
1387712|NCT01379768|Primary|Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).|Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
1387713|NCT01379768|Primary|Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.|Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
1387714|NCT01379768|Primary|Leukocyte Population|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.|Week 5|This reporting group includes all participants who completed the study per protocol.|||Leukocytes||Standard Deviation|Mean
1387720|NCT01379703|Primary|Laboratory Parameter Lipids|A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||millimoles per liter||Standard Deviation|Mean
1387721|NCT01379703|Primary|Laboratory Parameter Transaminases|Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||international units per liter||Standard Deviation|Mean
1387722|NCT01379703|Primary|Laboratory Parameter Blood Glucose|Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed after 9 months.|||millimoles per liter||Standard Deviation|Mean
1387723|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on last observation carried forward (N=660).|||Log10 copies per ml||Standard Deviation|Mean
1387724|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||Log10 copies per ml||Standard Deviation|Mean
1387725|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||Log10 copies per ml||Standard Deviation|Mean
1387726|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|9 months|Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).|||Log10 copies per ml||Standard Deviation|Mean
1387727|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|6 months||||Log10 copies per ml||Standard Deviation|Mean
1387728|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|3 months||||Log10 copies per ml||Standard Deviation|Mean
1387729|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|1 month||||Log10 copies per ml||Standard Deviation|Mean
1387730|NCT01379703|Primary|Viral Load|Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.|Baseline|Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.|||Log10 copies per ml||Standard Deviation|Mean
1387731|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 18 months.|||cells per mm³||Standard Deviation|Mean
1387732|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 15 months.|||cells per mm³||Standard Deviation|Mean
1387733|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 12 months.|||cells per mm³||Standard Deviation|Mean
1387734|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 9 months|Change from baseline analysis is based on participants with CD4 count results available at 9 months.|||cells per mm³||Standard Deviation|Mean
1387932|NCT01377467|Other Pre-specified|Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||mmol/L||95% Confidence Interval|Least Squares Mean
1387736|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 3 months|Change from baseline analysis is based on participants with CD4 count results available at 3 months.|||cells per mm³||Standard Deviation|Mean
1387737|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 1 month|Change from baseline analysis is based on participants with CD4 count results available at 1 month.|||cells per mm³||Standard Deviation|Mean
1387738|NCT01379703|Primary|CD4 Count|CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.|Baseline|Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.|||cells per mm³||Standard Deviation|Mean
1387739|NCT01379664|Secondary|Total Intraoperative Opioid Consumption|Total amount of opioid in IV morphine equivalents used during surgeyr|intraoperative||||mg||Standard Deviation|Mean
1387740|NCT01379664|Secondary|Time-weighted Average Verbal Rating Pain Score|Time-weighted average VRS (Verbal Rating Scale) pain score over the first 72 h after surgery as recorded by nurses at approximately 4-h intervals. The VRS pain score is from 0 (no pain) to 10 (worst imaginable pain).|up to 72 hours after surgery|Postoperative pain measurements were not available for 19 isoflurane patients and 20 sevoflurane patients.|||units on a scale||Standard Deviation|Mean
1387741|NCT01379664|Primary|Hospital Length of Stay||participants will be followed for the duration of hospital stay, an expected average of 3 days||||Days||Inter-Quartile Range|Median
1387742|NCT01379651|Secondary|Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP|Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.|Baseline and 6 months|We were unable to calculate sample size because no quantitative data about the clinical outcome could be hypothesized. Indeed, the few reports of food causing allergy, the protocol, the way of SOTI administration and food doses administered yielded reported variable results. the analysis was per intention to treat|||mm diameter||Full Range|Median
1387743|NCT01379651|Primary|Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg|To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.|baseline and 6 months||||participants|||Number
1387744|NCT01379625|Secondary|Exercise Heart Rate|Subjects will complete a submaximal treadmill exercise study at baseline. Exercise heart heart, ventilation and perceived exertion will be measured. Subjects will be randomized to MCT or triheptanoin supplementation for 4 months. At the end of treatment, the exercise test will be repeated keeping work performed constant. Change in exercise heart rate, ventilation and exertion will be compared between groups.|change from baseline to 4 months of treatment||||beats per minute||Standard Deviation|Mean
1387745|NCT01379625|Primary|Ejection Fraction|Change in resting ejection fraction over 4 month treatment period|4 months|Change in resting ejection fraction over 4 month treatment period calculated as: 4 month ejection fraction-baseline ejection fraction. Only participants with available data are included in this analysis.|||percent||Standard Deviation|Mean
1387746|NCT01379625|Primary|Energy Expenditure|Total energy expenditure will be measured by doubly labeled water and resting energy expenditure will be measured by indirect calorimetry at baseline and again after 4 months of either MCT or trihpetanoin treatment.|change from baseline after 4 months of treatment|One subject in each group did not complete the doubly labeled water measures. A total of 15 in each group measured total energy expenditure at baseline and at the end of the study. This value compares the change over treatment.|||kcal/day||Standard Deviation|Mean
1387747|NCT01379534|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|up to 30 days after the last dose of study drug, up to 18 weeks|Safety analysis set: The safety set included all participants who received at least one dose of study medication.|||Participants|||Number
1387748|NCT01379534|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Months||95% Confidence Interval|Median
1387749|NCT01379534|Secondary|Overall Survival (OS)|OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.|up to 18 weeks|Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.|||Months||95% Confidence Interval|Median
1387750|NCT01379534|Secondary|Duration of Response (DR)|Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.|up to 18 weeks|This outcome measure was not analyzed. The analysis was not required because there were too few responders.||||||
1387751|NCT01379534|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Percentage of participants|||Number
1387752|NCT01379534|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Percentage of participants|||Number
1387753|NCT01379534|Primary|Progression Free Survival (PFS) Rate|The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as “failure”. Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Percentage of participants|||Number
1387754|NCT01379521|Secondary|Percentage of Participants With a Decrease in the Sum of the of Longest Diameters (SLD) of Target Lesions From Baseline to 30 Months|Percentage of participants with a decrease in the sum of the of longest diameters (SLD) of target lesions from Baseline to 30 months|baseline, 30 months|Full Analysis Set (FAS) comprises all randomized patients.|||Percentage of participants|||Number
1387755|NCT01379521|Secondary|Incidences of Cumulative New Nodular Recurrence, Portal Vein Invasion and Extra Hepatic Metastases|Incidences of cumulative new nodular recurrence, portal vein invasion and extra hepatic metastases but incidence of portal vein invasion meant those patients without documented vascular invasion at screening/baseline. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|30 months|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
1387756|NCT01379521|Secondary|Overall Survival (OS)|Overall survival was defined as the time from date of randomization to date of death due to any cause. If death had not occurred at the date of the analysis cut-off then OS was censored at the date of the last contact.|6, 12, 18, 24, 30 months|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered|||months||90% Confidence Interval|Median
1387757|NCT01379521|Secondary|Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on Original RECIST|Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the Complete response: Disappearance of all target lesions or lymph nodes <10 mm in the short axis Partial response: >30% decrease in sum of the longest diameters (SLD) of target lesions Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
1387758|NCT01379521|Secondary|Time to Progression Based on Original RECIST|Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on original RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of target lesions with an absolute increase of ≥5 mm; new lesions. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
1387759|NCT01379521|Secondary|Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on the Modified RECIST|Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the modified RECIST. Complete response: Disappearance of arterial phase enhance-ment in all target lesions. Partial response: >30% decrease in sum of the longest diameters (SLD) of “viable” target lesion (arterial phase enhance-ment)Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
1387760|NCT01379521|Primary|Time to Progression (TTP) Based on the Modified RECIST Criteria|Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on modified RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of “viable” target lesion (arterial phase enhancement)|3, 6, 12, 18 and 24 months|Full Analysis Set (FAS) comprises all randomized patients.|||months||90% Confidence Interval|Median
1388873|NCT01368497|Secondary|Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1387761|NCT01379183|Secondary|Small Intestine and Colon Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
1387762|NCT01379183|Secondary|Small Intestine Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
1387763|NCT01379183|Secondary|Colonic Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
1387764|NCT01379183|Secondary|Ileal Volume|The Ileal is the terminal portion of the small intestine extending from the jejunum to the cecum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
1387765|NCT01379183|Secondary|Jejunal Volume|The jejunum is the section of the small intestine between the duodenum and the ileum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
1387766|NCT01379183|Primary|Gastric Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
1387767|NCT01378988|Primary|Number of Subjects Who Received Rescue Medication for Sedation and Analgesic|Participants who received rescue medication midazolam for sedation and/or fentanyl for analgesic during study drug Infusion|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate pharmacokinetic samples to estimate primary parameters.|||participants|||Number
1387768|NCT01378988|Primary|Absolute Time That Subject is in UMSS Range 2-4 During Treatment Period|"The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS).~Score 0 (awake/alert); Score 1 (sleepy/responds appropriately); Score 2 (somnolent/arouses to light stimuli); Score 3 (deep sleep/arouses to deeper physical stimuli); Score 4 (unarousable).~The UMSS scores obtained just prior the loading dose (LD) and 5 and 10 minutes during LD; 0, 5, 10, 15, 30, and 60 minutes and thereafter every 4 hours of the maintenance infusion; within 5 minutes of obtaining each pharmacokinetic sample; within 5 minutes prior and after any midazolam rescue during dexmedetomidine infusion period."|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Hours||Standard Deviation|Mean
1387769|NCT01378988|Primary|Average Total Faces, Legs, Activity, Cry, and Consolability (FLACC) Score|FLACC scale is a 5 category observational measure to assess pediatric pain on face, legs, activity, cry and consolability. Responses in each category are scored between 0 to 2 (0 = normal, relaxed to 2 = upset, rigid), for a maximum total score of 10.|Prior to loading dose and every hour during the maintenance infusion; within 5 minutes after any fentanyl administration during DEX infusion or every 4 hours in case of continuous fentanyl infusion; within 5 minutes prior and after titration of fentanyl|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||units on a scale||Standard Deviation|Mean
1387770|NCT01378988|Primary|Weight-Adjusted Volume of Distribution (Vdw)|Weight-Adjusted Volume of distribution of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre per Kilogram||Standard Deviation|Mean
1387771|NCT01378988|Primary|Volume of Distribution (Vd)|Volume of distribution of dexmedetomidine after intravenous administration. Volume of distribution measures how much the drug spreads through the body after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre||Standard Deviation|Mean
1387772|NCT01378988|Primary|Plasma Clearance (CL)|Clearance of dexmedetomidine after intravenous administration. Clearance is the rate at which the drug is removed from the plasma after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre per Hour||Standard Deviation|Mean
1387933|NCT01377467|Other Pre-specified|Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, thus all randomised patients with valid data at all time points were included.|||mmol/L||95% Confidence Interval|Least Squares Mean
1387773|NCT01378988|Primary|Weight-Adjusted Plasma Clearance (CLw)|Weight-Adjusted Plasma Clearance of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre per Hours per Kilogram||Standard Deviation|Mean
1387774|NCT01378988|Primary|Time to Reach Maximum Plasma Concentration (Tmax)|Observed time to reach maximum plasma concentration of dexmedetomidine, expressed in hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Hours||Standard Deviation|Mean
1387775|NCT01378988|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life of dexmedetomidine. Half-life is the time required for plasma concentration of the drug to decrease by 50%.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Hours||Standard Deviation|Mean
1387776|NCT01378988|Primary|Steady State Concentration (Css)|Concentration of dexmedetomidine at steady state in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||picogram per millilitre||Standard Deviation|Mean
1387777|NCT01378988|Primary|Observed Peak Plasma Concentration (Cmax)|Maximum observed concentration of dexmedetomidine in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||picogram per millilitre||Standard Deviation|Mean
1387778|NCT01378988|Primary|Area Under the Plasma Concentration-time Curve (AUC0-∞)|Area under the plasma concentration-time curve of dexmedetomidine at 0 to Infinity hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||picogram*hour per millilitre||Standard Deviation|Mean
1387779|NCT01378975|Secondary|Percentage of Participants With Adverse Events (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|From signing of informed consent form up to 28 days after the last dose of study drug (approximately up to 4 years)|The safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
1387780|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Not Necessarily Follows the RECIST Criteria - as Assessed by Investigator)|Percentage of participants who were responders (with best overall response (BOR) documented as confirmed complete response [CR] or partial response [PR]) were reported.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
1387781|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Assessed by Investigator)|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, ‘n’ indicates the number participants who were evaluable for within brain assessment and who had measurable disease outside brain at baseline for outside brain assessment.|||percentage of participants|||Number
1387782|NCT01378975|Secondary|Overall Survival|Overall survival was defined as time between enrollment on Day 1 and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the latest date they were known to be alive prior to or on the cutoff date.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||months||Full Range|Median
1387783|NCT01378975|Secondary|Time to Development of New Brain Metastases in Responders|Time to development of new lesions within the brain was defined as the interval between the date of first treatment and the earliest date of documentation of new brain lesions. Participants who were known to be free of new lesions were censored on the date of last tumor assessment.|Date of first treatment and the earliest date of documentation of new brain lesions (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, number of participants analyzed is the participants who were responders.|||months||Full Range|Median
1387934|NCT01377467|Secondary|P1NP at Baseline and Months 3, 6 and 12|Blood concentrations of P1NP were measured in microgram/L|baseline, month 3, month 6, and month 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||microgram/L||95% Confidence Interval|Least Squares Mean
1387784|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Tumor Assessment Within Brain Only (Assessed by Investigator )|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||months||Full Range|Median
1387785|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Overall Tumor Response (Assessed by Investigator)|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within or outside the brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||months||Full Range|Median
1387786|NCT01378975|Secondary|Duration of Response (DOR) (Assessed by Investigator and IRC)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the earliest date of PD or death from any cause. For participants who were alive without progression following the qualifying response, DOR were censored on the date of last available tumor assessment on or before the data cutoff date.|Date of the earliest qualifying response until the earliest date of PD or death from any cause (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, 'n' indicates number of participants who were responders within brain or outside brain assessed by investigator or IRC.|||months||Full Range|Median
1387787|NCT01378975|Secondary|Best Overall Response Rate Outside the Brain (Assessed by IRC)|BORR outside of brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, number participants analyzed is the total number of participants who had measurable disease outside brain at baseline.|||percentage of participants||95% Confidence Interval|Number
1387788|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated Brain Metastases as Assessed by the IRC Using RECIST v1.1|BORR within brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
1387789|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated or Untreated Brain Metastases as Assessed by the IRC Using RECIST v1.1|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||percentage of participants|||Number
1387790|NCT01378975|Primary|Best Overall Response Rate (BORR) Within Brain of Previously Untreated Participants (Assessed by Independent Review Committee [IRC] Using Modified Response Evaluation Criteria in Solid Tumors [RECIST])|BORR assessed by IRC is defined as percentage of participants who were responders [with best overall response (BOR) documented as confirmed complete response (CR) or partial response (PR)]. The RECIST v1.1 criteria modified for independent review of body and brain lesions was based on current radiology practices. The modifications to RECIST v1.1 included allowing target lesions in the brain to be >=5 mm by contrast-enhanced magnetic resonance imaging scan (in traditional RECIST v1.1 this is >=10 mm), allowing up to 5 target lesions in the brain (in traditional RECIST v1.1 only 2 target lesions), and examining the lesions within the brain and outside the brain separately for analytical purposes. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm), PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The intent to treat (ITT) population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
1387791|NCT01378962|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).|Baseline, At progression of disease (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had samples for EGFR mutation. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||percentage of participants|||Number
1387935|NCT01377467|Secondary|Beta-CTX at Baseline and Months 3, 6 and 12|Blood concentrations of beta-CTX (microgram/L)|baseline, month 3, month 6, and month 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||microgram/L||95% Confidence Interval|Least Squares Mean
1387792|NCT01378962|Secondary|Percentage of Participants With Primary and Secondary Resistance|Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline up to disease progression (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had a documented PD response during the study period.|||percentage of participants|||Number
1387793|NCT01378962|Secondary|Percentage of Participants Achieving CR, PR, or SD as Best Overall Response|The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1387794|NCT01378962|Primary|Probability of Being Progression Free 12 Months After Baseline|According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|ITT population.|||probability of being progression-free||Standard Error|Mean
1387795|NCT01378962|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.|Up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.|||months||90% Confidence Interval|Median
1387796|NCT01378962|Secondary|Percentage of Participants With Objective Response|Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1387797|NCT01378962|Secondary|Percentage of Participants With a Response by Best Overall Response|Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.|||percentage of participants|||Number
1387798|NCT01378962|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.|Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.|||months||Standard Error|Mean
1387799|NCT01378962|Secondary|Percentage of Participants Who Died||Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.|||percentage of participants|||Number
1387800|NCT01378962|Primary|Percentage of Participants With Disease Progression or Death at 12 Months After Baseline|According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|Intent to treat (ITT) population included all participants enrolled in the study who received at least 1 dose of treatment.|||percentage of participants|||Number
1387802|NCT01378520|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
1387803|NCT01378520|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for unpleasantness through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.~Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
1387804|NCT01378429|Secondary|Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||units on a scale||Standard Deviation|Mean
1387805|NCT01378429|Secondary|Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of devices|Participants||Number
1387806|NCT01378429|Secondary|Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||Devices|Participants||Number
1387807|NCT01378429|Secondary|Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of number of correct advances||Standard Deviation|Mean
1387808|NCT01378429|Secondary|Apparent Volume of Distribution (Vz/F)|Vz/F Liters (L) is the apparent volume of distribution|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||L||Standard Deviation|Mean
1387809|NCT01378429|Secondary|Apparent Clearance of the Drug (CL/F)|CL/F liter per hour (L/hour) is the apparent clearance of the drug|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||L/hour||Standard Deviation|Mean
1387810|NCT01378429|Secondary|Terminal Half Life (t1/2)|Terminal half-life (t1/2) (hour)|Weeks 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||Hour||Standard Deviation|Mean
1387811|NCT01378429|Secondary|Time to the Occurrence of Cmax|tmax (hour) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||Hour||Standard Deviation|Mean
1387812|NCT01378429|Secondary|Maximum Observed Concentration|Cmax (ng/mL) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
1387813|NCT01378429|Secondary|AUC(0-24h)|Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing.|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||ng*hr/mL||Standard Deviation|Mean
1387814|NCT01378429|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of participants|||Number
1387815|NCT01378429|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||participants|||Number
1388874|NCT01368497|Secondary|Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1387820|NCT01378429|Primary|The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period|Area under the concentration-time curve from time 0 to 24 hours [AUC(0-24h)]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.|Week 0 and 6|The Per Protocol (PP) population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no important protocol deviations (IPDs).|||mcg•hour/dL||Standard Error|Least Squares Mean
1387821|NCT01378416|Primary|AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, day 3||||ng∙hr/mL||Standard Deviation|Mean
1387822|NCT01378416|Primary|Tmax (Time at Which Cmax First Observed)|3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3||||hours||Standard Deviation|Mean
1387823|NCT01378416|Primary|Cmax (Maximum Plasma Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3||||ng/mL||Standard Deviation|Mean
1387824|NCT01378416|Primary|Average Total Body Clearance (Calculated From Rate and Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3||||L/hr/m^2|||Number
1387825|NCT01378416|Secondary|Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)|Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients|6 weeks||||Participants|||Number
1387826|NCT01378377|Secondary|Phospho Extracellular Signal Regulated Kinase (pERK ) Levels and Phospho Ribosomal Protein S6 (pS6) Levels in in Peripheral Blood Mononuclear Cells (PBMCs)|During the first cycle (either Cycle 1 non-DDI or Cycle 1-DDI) blood samples will be collected for pharmacodynamic marker assessments by flow cytometry such as phospho-ERK and phospho- S6 activities in PBMCs|DDI cohorts: Days 1, 9 and 10 of Cycle 1; Non-DDI cohorts: Days 1, 8 and 9 of Cycle 1|As the trial was terminated early due to toxicities observed with the combination of pimasertib and temsirolimus, it was decided as per plan not to evaluate the biomarker data for this study||||||
1387827|NCT01378377|Secondary|Number of Subjects With Disease Control Rate|Disease control is defined as confirmed complete response (CR), partial response (PR), or stable disease (SD) >=12 weeks), based on tumor assessments as determined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. CR: The disappearance of all lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline. SD: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started.|From the start of the trial treatment until data cut-off date (23 February 2012)|Data was not evaluated for this outcome as the subjects did not met the minimum criteria duration for the evaluation of the outcome measure due to the early termination of the trial||||||
1387828|NCT01378377|Secondary|Volume of Distribution (Vz) of Temsirolimus|The Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||liter||Full Range|Median
1387829|NCT01378377|Secondary|Apparent Volume of Distribution (Vz/F) of Pimasertib|Volume of distribution (Vz) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The Vz after oral dose (Vz/F) was influenced by the fraction absorbed. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|"Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N' =subjects evaluable for this outcome measure; Number Analyzed signifies subjects evaluable for this measure for specified categories for each reporting group, respectively."|||liter||Full Range|Median
1387830|NCT01378377|Secondary|Total Body Clearance From Plasma Following Intravenous Administration (CL) of Temsirolimus|The clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N' =subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||liter/hour||Full Range|Median
1387831|NCT01378377|Secondary|Apparent Clearance From Plasma Following Oral Administration (CL/f) of Pimasertib|Clearance (CL) of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The CL obtained after oral dose (CL/F) was influenced by the fraction of the dose absorbed (bioavailability). Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N’ =subjects evaluable for this outcome measure;“Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||liter/hour||Full Range|Median
1388028|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||mm^3||Standard Deviation|Mean
1387832|NCT01378377|Secondary|Apparent Terminal Half-life (t1/2) of Temsirolimus|The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. N=subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
1387833|NCT01378377|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib|The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N'=subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
1387834|NCT01378377|Secondary|Area Under Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Temsirolimus|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N’=subjects evaluable for this outcome measure;“Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour*nanogram/milliliter||Full Range|Median
1387835|NCT01378377|Secondary|Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) and Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib|The AUCtau was defined as the area under the concentration curve divided by the dosing interval. AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1 for AUCtau; DDI cohorts: Day 1 of Cycle 1 AUC0-inf|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N’=subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour*nanogram/milliliter||Full Range|Median
1387836|NCT01378377|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Temsirolimus|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
1387837|NCT01378377|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
1387838|NCT01378377|Secondary|Maximum Plasma Concentration (Cmax) of Temsirolimus|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 8|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||nanogram/milliliter||Full Range|Median
1387839|NCT01378377|Secondary|Maximum Plasma Concentration (Cmax) of Pimasertib|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|Drug-drug interaction (DDI) cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||nanogram/milliliter||Full Range|Median
1387840|NCT01378377|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. The TEAEs were those events that occur between first dose of trial treatment and up to 30 days after last dose of the trial treatment that were absent before treatment or that worsened relative to pretreatment state.|From the start of the trial treatment until data cut-off date (23 February 2012)|The safety analysis set included all the subjects who received at least one administration of trial medication.|||subjects|||Number
1387841|NCT01378377|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following toxicities graded as per National Cancer Institute (NCI) common terminology criteria for adverse events (NCI CTCAE v4.0) encountered within cycle 1 of treatment at any dose level and judged not to be related to the underlying disease or concomitant medications. A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation would expose subjects to unacceptable risk; any Grade >=3 non-hematological toxicity except Grade 3 asymptomatic increases in liver function tests, diarrhea, nausea or vomiting with duration <= 48 hours and alopecia; Grade 4 neutropenia of >5 days duration or febrile neutropenia of >1 day duration; Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; any treatment interruption >2 weeks due to adverse events; any severe, impairing daily functions or life-threatening, complication or abnormality not defined in NCI-CTCAE that is attributable to the therapy.|Up to 21 Days (within Cycle 1)|The dose escalation analysis set included all the subjects who received at least 80% of the planned doses of each treatment (pimasertib and temsirolimus) in the first cycle of treatment or who experienced DLT during the first cycle of treatment regardless of the received amount of drug.|||subjects|||Number
1387842|NCT01378325|Primary|Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.|"Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:~stopping the phenylephrine infusion~changing the rate of phenylephrine infusion~rescue intravenous bolus of phenylephrine (100 µg) for hypotension~rescue intravenous bolus of atropine (0.4 mg) for bradycardia"|Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).||||number of interventions||Full Range|Median
1387843|NCT01378221|Primary|Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients||change from baseline within 1 month after cardiac surgery||||percentage||Standard Error|Mean
1387844|NCT01378195|Secondary|Perceived Quality of Life|"The Perceived Quality of Life (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome."|3 months||||units on a scale||Standard Deviation|Mean
1387845|NCT01378195|Secondary|Revised Memory and Behavior Problems Checklist|"This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this bothered or upset them. A conditional bother score is calculated which is the upset or bother ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome."|3 months||||units on a scale||Standard Deviation|Mean
1387846|NCT01378195|Primary|Perceived Stress Scale|"The Perceived Stress Scale measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome."|3 months||||units on a scale||Standard Deviation|Mean
1387847|NCT01378117|Secondary|Hospital Mortality|Hospital mortality. Mortality is defined as death occurring during admission|during hospitalization, average 5 days|||||||
1387848|NCT01378117|Secondary|Acute Renal Failure|Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (serum creatinine > 2.2 mg/dL or an increment > 0.5 mg/dL from baseline).|during hospitalization, average 5 days|||||||
1387849|NCT01378117|Secondary|Composite Cardiac Complications|Cardiac complications are defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, congestive heart failure, or cardiac arrest.|during hospitalization, average 5 days|||||||
1387850|NCT01378117|Secondary|ICU Need|Need for ICU care (transfer to ICU)|during hospitalization, average 5 days|||||||
1387851|NCT01378117|Secondary|Total Daily Dose of Insulin||during hospitalization, average 5 days|||||||
1387852|NCT01378117|Secondary|Hyperglycemia|Number of episodes of hyperglycemia (BG > 300 mg/dl) after the first day of treatment.|during hospitalization, average 5 days|||||||
1387853|NCT01378117|Secondary|Severe Hypoglycemia|severe hypoglycemic events (<40 mg/dl).|during hospitalization, average 5 days|||||||
1387854|NCT01378117|Secondary|Hypoglycemia|Number of hypoglycemic events (<70 mg/dl)|during hospitalization, average 5 days|||||||
1387855|NCT01378117|Primary|Glucose Levels|The primary outcome of the study is to determine differences in glycemic control as measured by mean daily BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2DM.|during hospitalization, average 5 days||||mg/dl||Standard Deviation|Mean
1387856|NCT01378104|Secondary|IL28B Polymorphism Effect on SVR|We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.|post treatment 24 weeks|The patients who agreed to check the genotype were analysed.|||percentage of SVR|||Number
1387857|NCT01378104|Primary|Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a|We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.|post treatment 24 weeks|We present the result of intention-to-treat analysis.|||participants who achieved SVR|||Number
1387858|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 12 months|All subjects|||units on a scale||Standard Deviation|Mean
1387859|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 months|All subjects|||units on a scale||Standard Deviation|Mean
1387860|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 3 months|All subjects|||units on a scale||Standard Deviation|Mean
1389186|NCT01364740|Primary|AHI|Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.|One night||||events/hour||Standard Deviation|Mean
1387861|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 weeks|All subjects|||units on a scale||Standard Deviation|Mean
1387862|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 12 months|The 25 subjects who completed the PISQ-12 at the twelve month follow up visit.|||units on a scale||Standard Deviation|Mean
1387863|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 months|The 26 subjects who completed the PISQ-12 at the six month follow up visit.|||units on a scale||Standard Deviation|Mean
1387864|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 3 months|The 25 subjects who completed the PISQ-12 at the three month follow up visit.|||units on a scale||Standard Deviation|Mean
1387865|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 weeks|The 28 subjects who completed the PISQ-12 at the six week follow up visit.|||units on a scale||Standard Deviation|Mean
1387866|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months|Bladder function is measured by UDI-6 Questionnaire at 12 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 12 months|All subjects.|||units on a scale||Standard Deviation|Mean
1387867|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months|Bladder function is measured by UDI-6 Questionnaire at 6 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 months|All subjects.|||units on a scale||Standard Deviation|Mean
1387868|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months|Bladder function is measured by UDI-6 Questionnaire at 3 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 3 months|All subjects.|||units on a scale||Standard Deviation|Mean
1387869|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks|Bladder function is measured by UDI-6 Questionnaire at 6 weeks. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 weeks|All subjects.|||units on a scale||Standard Deviation|Mean
1387870|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.|"The PGI-I Index consists on one question and was collected at 12 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|12 months|All subjects|||participants|||Number
1387871|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.|"The PGI-I Index consists on one question and was collected at 6 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 months|The 29 subjects who completed the PGI-I at the six month follow up visit.|||participants|||Number
1387872|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.|"The PGI-I Index consists on one question and was collected at 3 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|3 months|The 29 subjects who completed the PGI-I at the three month follow up visit.|||participants|||Number
1387873|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.|"The PGI-I Index consists on one question and was collected at 6 weeks. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 weeks|The 29 subjects who completed the PGI-I at the six week follow up visit.|||participants|||Number
1387874|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 month|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.|||percentage of subjects|||Number
1387875|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 month|The 5 subjects who were treated in the posterior compartment with Restorelle Direct Fix and have POP-Q measurement recorded at the six month follow-up visit.|||percentage of subjects|||Number
1387876|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 month|The six subjects who had posterior compartment vaginal reconstruction surgery.|||percentage of subjects|||Number
1387877|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 week|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.|||percentage of subjects|||Number
1387878|NCT01378065|Secondary|Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.|"Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months. Per the protocol, mesh extrusion is defined as passage gradually out of a body structure or tissue. Mesh exposure is defined as  a condition of displaying, revealing, exhibiting or making accessible e.g. vaginal mesh visualized through separated vaginal epithelium."|12 months|All study subjects.|||percentage of subjects|||Number
1387879|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|12 months|All subjects|||participants|||Number
1387880|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 months|All subjects|||participants|||Number
1387881|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|3 months|All study subjects|||participants|||Number
1387882|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 weeks|All subjects|||participants|||Number
1387883|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
1387884|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
1387885|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
1387886|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks|Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 weeks|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
1387887|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 12 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|12 months|The 11 sexually active subjects without dyspareunia at baseline. At the 12 month follow-up visit, only 11 subjects were sexually active and thus only 11 subjects completed Question 3.5 on the PISQ-12 questionnaire. Therefore, the number of participants analyzed for this outcome was 11 at the 12 month follow-up visit.|||percentage of subjects|||Number
1387888|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at six months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 months|The 12 sexually active subjects without dyspareunia at baseline.|||percentage of subjects|||Number
1387889|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 3 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|3 months|The 12 sexually active subjects without dyspareunia at baseline.|||percentage of subjects|||Number
1387890|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 weeks|The 12 sexually active subjects without dyspareunia at baseline.|||percentage of subjects|||Number
1387891|NCT01378065|Primary|Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|Baseline|All subjects|||participants|||Number
1387892|NCT01377987|Secondary|Pittsburgh Sleep Quality Index|Pittsburgh Sleep Quality Index is a measure of self-reported sleep quality containing 19 questions that make up 7 component scores that are added to provide a total score. Total scores range from 0-21 (units on a scale) with higher scores representing reduced sleep quality. A score of 5 or more is interpreted as reduced sleep quality. The total score is reported.|1 week|All participants who participated in the relevant study arm.|||units on a scale||Standard Deviation|Mean
1387893|NCT01377987|Secondary|Brain Natriuretic Peptide (NT-proBNP)|Brain natriuretic peptide (NT-proBNP) in morning|1 week|All participants who completed the relevant arm|||pg/ml||Standard Deviation|Mean
1387894|NCT01377987|Secondary|Left-atrial Volume|Left-atrial volume index, echocardiography, bi-plane method. Lower values were considered a favorable outcome. We considered values ≤28 mL/m^2 to indicate normal left atrial volume. Values indicating graded left atrial enlargement were described as follows: mild (29-33 mL/m^2), moderate (34-39 mL/m^2), severe (≥40 mL/m^2).|1 week|echocardiography could not be performed on one study due to rescheduling issues|||mL/m^2||Standard Deviation|Mean
1387895|NCT01377987|Secondary|Sympathetic Activity (Urinary Norepinephrine)|Urinary norepinephrine levels overnight|1 week|All participants who completed the relevant study arm|||ug/g-creatinine||Standard Deviation|Mean
1387896|NCT01377987|Secondary|"Ventilatory Chemoreflex Sensitivity, Loop Gain Using Carbon Dioxide Pulses"|"Chemoreflex loop gain was assessed according to Sands SA et al AJRCCM 2017 Jan 15;195(2):237-246. Loop gain is a unitless ratio measure that describes the magnitude of the increase in ventilation that occurs in response to a prior reduction in ventilation (disturbance) and has units of L/min per L/min. A larger value indicates a more sensitive and unstable control system predisposing to oscillatory breathing. Loop gain was measured on the time scale of 1 min (i.e. response to a 1 cycle/min sinusoidal disturbance, referred to as LG1). The procedure involved brief administration of 7% carbon dioxide in air for 0.5 min (pulses); tests were repeated every 3 min for 30 min while measuring ventilation and carbon dioxide levels at the nose with patients awake and supine.~measured using 0.5 min pulses of carbon dioxide."|1 week|All participants who completed the relevant arm. Morning data are reported.|||unitless||Standard Deviation|Mean
1387897|NCT01377987|Primary|The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)|The frequency of apneas and hypopneas (apnea-hypopnea index) was assessed. The primary measure was the value for non-REM supine sleep. A higher value indicates more severe sleep apnea. A value above 15 indicates the presence of moderate-to-severe sleep apnea.|1 week|All participants who were randomized and completed the relevant study arm. Data are for non-REM supine sleep.|||events per hour||Standard Deviation|Mean
1387898|NCT01377922|Secondary|Change in CGI-I Score|"The Investigator completed the 7-point CGI I, based on changes in symptoms, behavior, and functional abilities, at the protocol-specified time points compared to the patient’s condition at Day 0.~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse"|Baseline and Day 14||||CGI-I score||Standard Deviation|Mean
1387899|NCT01377922|Secondary|Change From Baseline Timed 25 Foot Walking Test (T25FW) at 14 Days|"The T25FW test, a component of the Multiple Sclerosis Functional Composite, was a quantitative mobility and leg function performance test based on a timed 25-foot walk (National Multiple Sclerosis Society). The patient was directed to walk a clearly marked 25-foot course as quickly and safely as possible. Following a rest of at least 5 minutes, the timed 25-foot walk was repeated. Patients could use assistive devices, such as canes, crutches, or walkers.~All data were normalized to the number of feet per minute, so if the patient walked 25 feet in less than a minute, the result was a speed greater than 25 feet/minute.~The measurement for the T25FW test was the average speed, expressed in feet/minute, of the 2 completed walks."|Assessment at Baseline and Day 14||||feet/minute||Standard Deviation|Mean
1387900|NCT01377922|Primary|Change in SGI Score|"Subject Global Impression (SGI) is a measure of changes in subject's perception of change in overall wellbeing.~The patient is asked to use the 7-point scale below to rate their impression of the effects of the study medication during the preceding 3 days on their physical well being.~Terrible~Mostly dissatisfied~Mixed~Partially satisfied~Mostly satisfied~Pleased~Delighted"|Assessment at Baseline and Day 14|FAS|||SGI score||Standard Deviation|Mean
1387901|NCT01377922|Primary|Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days|The QMG is a physician-rated test including 13 assessments, including facial strength, swallowing, grip strength, and duration of time that limbs can be maintained in outstretched positions. Each of the 13 items is scored from 0 (none) to 3 (severe). The total score can range from 0 to 39. Increased QMG total score correlates to worsening symptoms of LEMS.|Assessment at Baseline and Day 14||||QMG Score||Standard Deviation|Mean
1387902|NCT01377636|Primary|BIS Change|The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.The difference between Pre-BIS and Post-BIS was calculated.|Within 20 minutes of starting isoproterenol infusion||||units on a scale||95% Confidence Interval|Mean
1387903|NCT01377636|Other Pre-specified|Number of Participants Who Developed Ischemia or ST Segment Changes|The (ST) segment on the EKG was monitored for changes suggestive of demand ischemia. An observable EKG change compared to baseline was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
1387904|NCT01377636|Other Pre-specified|Number of Participants With New Arrhythmia During Steady State.|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation after return to sinus rhythm. If a non-sinus arrhythmia resulted from the infusion, the arrhythmia was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of start of isoproterenol||||participants|||Number
1387905|NCT01377636|Other Pre-specified|Number of Participants With Amnesia or No Recall During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Specific pre-determined test words were spoken to the subject during administration of isoproterenol. After anesthesia, patients were tested for possible recall of those specific words. If no words were recalled, the result was categorically defined as amnesia.|Within one hour of completing anesthesia||||participants|||Number
1387906|NCT01377636|Other Pre-specified|Number of Participants With Change in Blood Pressure|Non-Invasive Blood Pressure (NIBP) is measured routinely as part of an anesthetic. Pre- and Post Blood Pressures where noted. An increase or decrease of 10 percent or more was defined as a significant change in systolic blood pressure.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
1387907|NCT01377636|Other Pre-specified|Number of Participants With Significant Change in Heart Rate|Heart rate measured by standard EKG monitor during anesthesia. Pre- and Post Heart rates where noted. An increase of 8 percent or more was defined as a significant change in heart rate.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
1387908|NCT01377636|Secondary|Number of Participants Who Follow Verbal Command to Squeeze Hands|"Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Ability to follow verbal commands before and after isoproterenol infusion was assessed by asking subjects to squeeze my hands."|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
1387909|NCT01377636|Secondary|Number of Participants With Spontaneous Musculoskeletal Movement|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Patients under steady state total venous anesthesia (TIVA) with propofol and remifentanil infusions with BIS around 50 normally do not move even in the absence of neuromuscular blockade. Spontaneous movement appearing like restlessness during sleep is unusual. Several patients under anesthesia after isoproterenol appear to wake up and move spontaneously.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
1387910|NCT01377636|Primary|Number of Participants With an Increase in BIS Readings During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. BIS levels were measured continuously before and after isoproterenol administration. Number of participants with increase in BIS reading during anesthetic steady state are reported below. The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.|During time of Electrophysiology (EP) studies.||||participants|||Number
1387911|NCT01377623|Secondary|Concentration of IL-8||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
1387912|NCT01377623|Secondary|Concentration of IL-6||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
1387913|NCT01377623|Secondary|Concentration of IL-1a||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
1387914|NCT01377623|Secondary|Concentration of TNF-alpha||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
1387915|NCT01377623|Primary|Quality of Recovery Score (QoR-40)|The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).|Post-operative Day 3||||units on a scale||Standard Deviation|Mean
1387916|NCT01377584|Secondary|Continuous Positive Airway Pressure (CPAP) Adherence|Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure. The latter number represents the amount of time power is on and the mask is positioned properly on the face. All patients will be using a CPAP machine with remote monitoring capabilities. Adherence reports are automatically uploaded to a secure data center daily. Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere.|one week, one month, and 3 months after CPAP initiation||||hours of use||Standard Deviation|Mean
1387917|NCT01377584|Primary|Sleep Quality|The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score > 5 indicates a poor sleeper.|baseline and 3 months after CPAP initiation||||units on a scale||Standard Deviation|Mean
1387918|NCT01377584|Primary|Sleep-related Functional Outcomes|The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.|baseline and 3 months after CPAP initiation||||units on a scale||Standard Deviation|Mean
1387919|NCT01377584|Primary|Daytime Sleepiness|The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of > 10 indicates excessive daytime sleepiness.|baseline and 3 months after CPAP initiation||||units on a scale||Standard Deviation|Mean
1387920|NCT01377480|Primary|Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction|Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.|Day 180|The Full Analysis Population included all randomized subjects who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1387921|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387922|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387923|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387924|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387925|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387926|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387927|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387928|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
1387929|NCT01377467|Other Pre-specified|1,25-(OH)2 Vitamin D3|Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||ng/L||95% Confidence Interval|Least Squares Mean
1387930|NCT01377467|Other Pre-specified|25-OH-vitamin D3|Blood levels of 25-OH-vitamin D3 were measured as microgramm/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||microgramm/L||95% Confidence Interval|Least Squares Mean
1387931|NCT01377467|Other Pre-specified|Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12|Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12|baseline and months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||ng/L||95% Confidence Interval|Least Squares Mean
1389200|NCT01364584|Secondary|Echocardiographic Measures - Stroke Volume|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||mL/beat||Standard Deviation|Mean
1387936|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 6|The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
1387937|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 6|The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
1387938|NCT01377467|Secondary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6|The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.|Baseline and month 6|The intention-to-treat was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
1387939|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 12|The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
1387940|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 12|The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
1387941|NCT01377467|Primary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12|The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the primary efficacy analysis, i.e. all subjects were included that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
1387942|NCT01377441|Secondary|Quality of Recovery Score (QoR-40).|The secondary outcome parameters will be the quality of recovery score (QoR-40) to measure quality of recovery from surgery, a simple fatigue scale, digits forward and backward, and the global depression schedule. Forty questions in five dimensions will be scored by patients on a five-point Likert scale. Seven point fatigue scales (in- and out-patient) is often used to assess progress of recovery in head trauma patients. Metrics will be administered on at the baseline visit and or on the day of surgery and on postoperative days 1, 2, 4 and 6.|48h|No data displayed because Outcome Measure has zero total participants analyzed.||||||
1387943|NCT01377441|Primary|Concentrations of the Cytokines Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin IL-1Beta (IL-1Beta), IL-2, IL-6, IL-10, and Interferon-gamma (IFN-gamma) as Well as Prostaglandin E2 at Different Time Points.|Concentration of the cytokines TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, and IFN-gamma as well as prostaglandin E2 at different time points will be our primary outcome. Changes in mediator levels in the IV ibuprofen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), at the end of the surgery, and on the first postoperative day.|48h|Unfortunately, due to major flooding at our site, due to Hurricane Sandy, all data and samples for this study were lost. Therefore, it was impossible to analyze any data for this study.||||||
1387944|NCT01377402|Secondary|Participants With Cardiac Events During Follow-up.|Cardiovascular Death. Myocardial infarctions (re-MIs) defined according to WHO criteria of 1979.|2-5 years||||Participants|||Number
1387945|NCT01377402|Primary|Total Mortality.|Mortality for any reason|2-5 years|Patients with suspected ACS|||participants|||Number
1387946|NCT01377233|Secondary|Clinical Global Impression Improvement Scale (CGI-I)|The CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)|||units on a scale||Standard Deviation|Mean
1387947|NCT01377233|Secondary|Clinical Global Impression Severity Scale (CGI-S) Change From Baseline|The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)|||units on a scale||Standard Error|Mean
1388029|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||mm^3||Standard Deviation|Mean
1388129|NCT01375127|Primary|Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)|All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
1387948|NCT01377233|Secondary|Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the analysis.|||units on a scale||Standard Error|Mean
1387949|NCT01377233|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)|11 weeks for open-label period; 13 weeks for double-blind period|Adverse events for the 46 patients enrolled in the open-label period are reported in the first (open-label) study arm. Adverse events for the 42 patients (out of the 46 enrolled) who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.|||participants|||Number
1387950|NCT01377194|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.|||units on a scale||Standard Error|Least Squares Mean
1387951|NCT01377194|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.|The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.|||Units on a scale||Standard Deviation|Mean
1387952|NCT01377012|Primary|Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70||up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
1387953|NCT01377012|Secondary|Extension Phase: Immunogenicity Against Secukinumab||up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
1387954|NCT01377012|Secondary|Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2|Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.|Baseline, up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
1387955|NCT01377012|Secondary|Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission|ACR/EULAR remission is defined as SDAI ≤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease|up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
1387956|NCT01377012|Secondary|Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses|Low Disease Activity is defined as DAS28 ≤ 3.2. EULAR good response requires an improvement of > 1.2 in the DAS28 score with a present score of ≤3.2; EULAR moderate response is defined as an improvement of >0.6 to ≤1.2 in DAS28 and a present score of ≤5.1; or an improvement of >1.2 and a present score of >3.2.|up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
1387957|NCT01377012|Secondary|Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
1388030|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||µm||Standard Deviation|Mean
1387958|NCT01377012|Primary|Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.|Week 24|The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned.|||Percentage of Participants|||Number
1387959|NCT01377012|Secondary|Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52|The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR70 response results at week 24 used non-responder imputation.|52 week|The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned. N=The total number of subjects in the treatment groups with evaluation|||Percentage of Participants|||Number
1387960|NCT01377012|Secondary|Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score|Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.|Week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed.|||Score on a scale||Standard Error|Mean
1387961|NCT01377012|Secondary|Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|Baseline, Week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Score on a scale||Standard Error|Least Squares Mean
1387962|NCT01376908|Secondary|Population PK Parameter: Time to Maximum Plasma Concentration (Tmax)||Up to Week 26|Tmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/F and interindividual variability could not be estimated for Ka.||||||
1387963|NCT01376908|Secondary|Population PK Parameter: Maximum Observed Plasma Concentration (Cmax)||Up to Week 26|Cmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/f and interindividual variability could not be estimated for absorption rate constant (Ka).||||||
1387964|NCT01376908|Secondary|Population PK Parameter: Terminal Elimination Half-life (t1/2)|The t1/2 was defined as the time required for plasma concentration of drug to decrease 50 percent (%) in the final stage of elimination. Since t1/2 could not be obtained from non-compartmental analysis because of sparse data, t1/2 was estimated as Log(2)*(V/F)/(CL/F), where V/F & CL/F were the population apparent central Volume & clearance, estimated from population PK model. The reason for pooling subjects receiving Kuvan & subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.|||hours|||Number
1387965|NCT01376908|Secondary|Population PK Parameter: Area Under the Plasma Concentration Curve, Time 0 to Infinity (AUC [0-infinity])|AUC [0-infinity] was estimated by determining total area under the curve of the concentration versus time curve extrapolated to infinity. Since AUC could not be obtained from non-compartmental analysis because of sparse data, AUC = Dose/(CL/F); CL/F was population apparent clearance estimated from the population PK model, & Dose the actual total dose received by the patient on one dosing interval. The reason for pooling subjects receiving Kuvan &subjects with Phe-restricted Diet was to facilitate estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led to biased estimated of Kuvan PK parameters. This pooling assumes that the the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 were same for the 2 arms and cannot be presented per arm/per treatment group as per planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.|||microgram*hour per liter(mcg*hour/liter)||Standard Deviation|Mean
1387966|NCT01376908|Secondary|Population PK Parameter: Apparent Volume of Distribution (V/f)|V/f is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.|||liter||Standard Error|Mean
1387967|NCT01376908|Secondary|Population Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/f)|CL/f is the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways.The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.|||liter per hour||Standard Error|Mean
1387968|NCT01376908|Secondary|Number of Samples With Phenylalanine Hydroxylase (PAH) Gene Mutations|The DNA samples received were quantified by using a nanophotometer, and were aliquoted to a concentration of 20 nanogram/microliter DNA and aliquots from each sample were distributed to one 96-well plate. All samples were Sanger sequenced regarding exons 1 to 13 of the PAH gene in forward direction using the DNAs in the 96-well plate. All samples showing variants were Sanger sequenced regarding the concerned exon in reverse direction using DNA from the original tube. All samples showing a homozygous mutation were analyzed by MLPA. All samples showing only 1 mutation were analyzed by MLPA. All samples showing only 1 or no mutation were resequenced completely (exons 1 to 13) in both directions.|Screening (within 42 days prior to Day 1 of the 26-week study period)|Analysis population included subjects who signed pharmacogenetics (PGx) informed consent and whose samples were available for analysis. Out of 109 subjects screened for the study, 77 PGx informed consent forms were signed and 73 samples were analyzed.|||Sample|||Number
1387969|NCT01376908|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."|||mmHg||Standard Deviation|Mean
1387970|NCT01376908|Secondary|Dietary Phe Tolerance During Extension Period|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Every 6 months during 3 year extension period or until product is commercially approved|The extension period of this study is ongoing. Data will be provided after completion of extension period i.e first quarter 2017||||||
1387971|NCT01376908|Secondary|Number of Subjects With Hypophenylalanemia|Hypophenylalanemia is defined as the condition of blood Phe levels <120 mcmol/L.|Week 26|Safety population consisted of all subjects who had some safety assessment data available (at least one visit in vital signs, AE or laboratory results) in the Study Period and who received at least one dose of Kuvan in the Study Period, or who were randomized to Phe-restricted diet alone.|||Subjects|||Number
1387972|NCT01376908|Secondary|Growth Parameters Standard Deviation Scores (SDS)|Growth assessment was performed by monitoring body mass index, height (or length), weight, and maximal occipital-frontal head circumference (MOFHC). Supine length was measured up to 2 years of age thereafter standing height was measured unless subject was unable to stand upright, in which case supine length was measured. Respective parameter SDS was calculated as the value of parameter minus reference mean value of parameter divided by standard deviation of the reference population.|Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."|||SDS||Standard Deviation|Mean
1387973|NCT01376908|Secondary|Neurodevelopmental Status Assessed Using Bayley III Scales of Infant and Toddler Development|Neurodevelopmental assessments was done using the following age-dependent scales: Bayley III for subjects less than (<) 3.5 years of age and WPPSI III for subjects greater than or equal to (>=) 3.5 to <4 years of age, based on following scores: adaptive behavior composite (ABC) score, cognitive composite (CC) score, language composite (LC) score, motor composite (MC) score., and social-emotional composite (SEC) score. Composite scores ranged from 40 (very poor) to 160 (excellent) and are classified as following: >=115: accelerated performance; 85-114: development within normal limits; 70-84: mildly delayed development; less than or equal to (<=) 69: significant delayed development.|Baseline and Week 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."|||Units on a scale||Standard Deviation|Mean
1388031|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||µm||Standard Deviation|Mean
1403453|NCT01234103|Secondary|Self-reported Behavioral Measures Related to STI/HIV Prevention||6 to 9 months|No data were collected from participants. Participants only attended intervention sessions.||||||
1387974|NCT01376908|Secondary|Number of Subjects With Normal Neuromotor Developmental Milestones Assessed Using Denver Developmental Scale (DDS)|"Subjects with normal neuromotor development were assessed by standardized developmental milestones using a parent/guardian report form in the following areas: fine motor, gross motor, language, and personal-social using DDS Test. DDS Test is a widely used to examine the developmental progress of 0-6 years of children. The scale reflects what percentage of a certain age group is able to perform a certain task. Tasks are grouped into 4 categories (social contact, fine motor skill, language, and gross motor skill) and include items such as smiles spontaneously (performed by 90% of three-month-olds), knocks 2 building blocks against each other (90% of 13-month-olds), speaks 3 words other than mom and dad (90% of 21-month-olds), or hops on 1 leg (90% of 5-year-olds). The more items a child fails to perform (passed by 90% of his/her peers), the more likely the child manifests a significant developmental problems."|Baseline, Weeks 12, 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."|||subjects|||Number
1387975|NCT01376908|Secondary|Number of Subjects With Any TEAEs, AEs Related to Kuvan, Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study treatment and up to 31 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 31 days after the last dose of study drug administration|Safety population included all subjects who either received at least one dose of Kuvan in the study period, or were randomized to Phe-restricted diet alone and who had some safety assessment data available.|||subjects|||Number
1387976|NCT01376908|Secondary|Change From Baseline in Dietary Phe Tolerance After 26 Weeks|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Baseline and at Week 26 (last observation carried-forward [LOCF])|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.|||mg/kg/day||Standard Error|Mean
1387977|NCT01376908|Secondary|Mean Blood Phe Levels|Mean blood phe levels were defined as the mean of blood phe levels assessed over each 2-week intervals|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.|||micromol per liter (mmol/L)||Standard Deviation|Mean
1387978|NCT01376908|Primary|Dietary Phenylalanine (Phe) Tolerance at Week 26|Phe tolerance was defined as the amount of dietary Phe prescribed (milligram per kilogram per day [mg/kg/day]) while maintaining blood Phe levels within the selected therapeutic target range (defined as greater than or equal to [>=] 120 to less than [<] 360 micromoles per liter [mcmol/L]).|Week 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated.|||mg/kg/day||Standard Error|Mean
1387979|NCT01376804|Secondary|Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)|All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.|52 Weeks|All patients meeting the resistance analysis criteria are included into the resistance analysis.|||Participants|||Number
1387980|NCT01376804|Secondary|Number of Participants With Death||52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
1387981|NCT01376804|Secondary|Number of Participants With Graft Loss|Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
1387982|NCT01376804|Secondary|Number of Participants With Biopsy Proven Rejection|Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
1387983|NCT01376804|Secondary|Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant|Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above.|52 weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
1387984|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
1387985|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
1387986|NCT01376804|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs|"An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs.~A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant."|52 weeks|Safety Population included all enrolled patients who received at least one dose of study medication and had at least one post-baseline assessment of safety.|||Participants|||Number
1387987|NCT01376700|Post-Hoc|Number of Inhibitors in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) - (Only ‘True’ Inhibitors)|"PUPs = no previous FVIII exposure; MTPs ≤4 previous FVIII exposures~’True’ positive inhibitor (PI) = any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, per study protocol) assessed as either:~i. High FVIII inhibitor titer (>5 BU/mL)~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as ‘true’ positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:~a) Lower or absent therapeutic response at infusion of standard replacement doses (“clinically relevant”) as deemed by clinician in charge.~b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.~Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:~> 5 BU/mL, categorized as high-titer inhibitor~≥0.6 BU/mL but ≤5 BU/mL, categorized as low-titer"|50 exposure days to ADVATE|Safety Analysis Set|||inhibitors|||Number
1387988|NCT01376700|Post-Hoc|Number of Participants With Factor VIII (FVIII) Inhibitors by Inhibitor Type (Only ‘True’ Inhibitors)|"’True’ positive inhibitor (PI) defined as any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, in accordance with study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL)~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as ‘true’ positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:~a) Lower or absent therapeutic response at infusion of standard replacement doses (“clinically relevant”) as deemed by the clinician in charge.~b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.~Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:~> 5 BU/mL, then categorized as a high-titer inhibitor~≥0.6 BU/mL but ≤5 BU/mL, then categorized as a low-titer."|50 exposure days to ADVATE|Safety Analysis Set|||participants|||Number
1387989|NCT01376700|Secondary|Number of Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) at Least Possibly Related to ADVATE|Possibly or probably related adverse events|50 exposure days to ADVATE|Safety Analysis Set|||adverse events|||Number
1387990|NCT01376700|Secondary|FVIII-Specific Antibody Isotype for All Participants at Study Entry and Every 10 Exposure Days (EDs)||50 exposure days to ADVATE|Summary statistics of FVIII-Specific Antibody Isotypes were not performed due to the early termination of the study||||||
1387991|NCT01376700|Secondary|Total Factor VIII (FVIII) Consumption by Participant||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess the total FVIII consumption by participant||||||
1387992|NCT01376700|Secondary|Correlation of Known Risk Factors to Factor VIII (FVIII) Inhibitor Formation||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess associations between known risk factors to inhibitor formation.||||||
1387993|NCT01376700|Secondary|Number and Type of Surgeries|"Elective surgery is not allowed during period of first 20 exposure days (EDs)~Peripherally inserted central catheter (PICC)"|50 exposure days to ADVATE|Safety Analysis Set|||surgeries|||Number
1387994|NCT01376700|Secondary|Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)|"Nominal Dosing Frequency:~1 time per week~2 times per week~Unknown dosing frequency (UK)~Bleeding Type (BT):~Skin~Muscle and Soft Tissue~Mucosal~Joint~Other~Multiple~Total~Bleeding severity:~Minor~Moderate~Severe~Total"|50 exposure days to ADVATE|Safety Analysis Set|||Bleeds|Bleeds||Number
1387995|NCT01376700|Secondary|Number of Participants With Low-titer, High-titer, Transient, and All Factor VIII (FVIII) Inhibitors|"High FVIII inhibitor titer (> 5 Bethesda Unit (BU)/mL)~Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)"|50 exposure days to ADVATE|Safety Analysis Set|||participants|||Number
1387996|NCT01376700|Secondary|Number of Exposure Days of Treatment With Advate Prior to First Positive Factor VIII (FVIII) Confirmed Inhibitor Assessment|"Confirmed inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 BU/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set|||days||Inter-Quartile Range|Median
1387997|NCT01376700|Secondary|Number of Participants With Severe Hemophilia A (FVIII ≤ 1%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.~Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set|||participants|||Number
1388032|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||µm||Standard Deviation|Mean
1387998|NCT01376700|Primary|Number of Participants With Severe and Moderately Severe Hemophilia A (FVIII ≤ 2%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.~Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|"Safety Analysis Set~All study participants had severe Hemophilia A, less than 1% Factor VIII levels. (ie there were no moderately severe hemophilia A participants (FVIII levels >1% to ≤ 2%) in this study."|||participants|||Number
1387999|NCT01376557|Secondary|Change From Baseline in Triglycerides at Week 12||12 weeks|ITT|||mg/dL||Standard Deviation|Mean
1388000|NCT01376557|Secondary|Change From Baseline in Systolic Blood Pressure (SPB) at Week 12||12 weeks|ITT|||mm Hg||Standard Deviation|Mean
1388001|NCT01376557|Secondary|Change From Baseline in Body Weight at Week 12||12 weeks|ITT|||kg||Standard Deviation|Mean
1388002|NCT01376557|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12||12 weeks|ITT|||mg/dL||Standard Deviation|Mean
1388003|NCT01376557|Secondary|Number of Participants Achieving a HbA1c Value of <7% at Week 12||12 weeks|ITT|||participants|||Number
1388004|NCT01376557|Primary|Change From Baseline in HbA1c to Week 12||12 weeks|ITT|||% change||Standard Deviation|Mean
1388005|NCT01376388|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD visits were conducted for participants who completed the Week 24 visit or withdrew before Week 24 and completed the Week 52 visit or withdrew before Week 52, respectively. The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|Baseline (Screening visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."|||Participants|||Number
1388006|NCT01376388|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population."|||Beats per minute||Standard Deviation|Mean
1388007|NCT01376388|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population."|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1388008|NCT01376388|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||Millimoles/Liter (MMOL/L)||Standard Deviation|Mean
1388033|NCT01376362|Primary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||µm||Standard Deviation|Mean
1389201|NCT01364584|Secondary|Echocardiographic Measures - Longitudinal Strain|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||% difference in lengths||Standard Deviation|Mean
1388009|NCT01376388|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measuremnt of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||Micromoles/Liter (µM/L)||Standard Deviation|Mean
1388010|NCT01376388|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||International Units/Liter (IU/L)||Standard Deviation|Mean
1388011|NCT01376388|Secondary|Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."|||Proportion||Standard Deviation|Mean
1388012|NCT01376388|Secondary|Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)|Blood samples were collected for the measurement of hemoglobin, albumin, and total protein at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||Grams/Liter (G/L)||Standard Deviation|Mean
1388013|NCT01376388|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurment of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X'' in the category title.|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
1388014|NCT01376388|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X in the category title."|||Percentage of cells in blood||Standard Deviation|Mean
1388045|NCT01376323|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI)|Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12. Data for parameters with high and low of PCI is provided.|Up to Week 12|Safety population|||Participants|||Count of Participants
1388015|NCT01376388|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|52 weeks|ITT Population|||Participants|||Number
1388016|NCT01376388|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of >=5%) and SAEs.|52 weeks|Intent-to-Treat (ITT) Population: all participants who had received at least one dose of study drug|||Participants|||Number
1388017|NCT01376362|Secondary|Proportion of Participants With a Visual Loss of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in the Study Eye|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks||||Percentage of Participants|||Number
1388018|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks||||mm Hg||Standard Deviation|Mean
1388019|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks||||mm Hg||Standard Deviation|Mean
1388020|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week||||mm Hg||Standard Deviation|Mean
1388021|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week||||mm Hg||Standard Deviation|Mean
1388022|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks||||ETDRS Letters||Standard Deviation|Mean
1388023|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks||||ETDRS Letters||Standard Deviation|Mean
1388024|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week||||ETDRS Letters||Standard Deviation|Mean
1388025|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week||||ETDRS Letters||Standard Deviation|Mean
1388026|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||mm^3||Standard Deviation|Mean
1388027|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||mm^3||Standard Deviation|Mean
1388411|NCT01372605|Secondary|Appointment Adherence|Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment|12 months|All participants with available medical chart data on appointment attendance were analyzed. Some participants did not complete the study but still contributed chart abstraction data.|||Percent of appts that were kept||Standard Deviation|Mean
1388034|NCT01376349|Primary|Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks|"The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1=none, 2=mild, 3=moderate, 4=severe and 5=very severe to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline)."|At baseline and 12 weeks|All patients that started treatment and completed their week 12 evaluation are included in this analysis.|||change in units on a scale||Full Range|Median
1388035|NCT01376323|Secondary|Number of Participants With HbA1c < 7.0% and < 6.5%|Data has been presented for number of participants with their corresponding percentages with HbA1c <7.0% and <6.5%.|Up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1388036|NCT01376323|Secondary|Change From Baseline in Fructosamine at Week 6 and Week 12|Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12.|Baseline (Day -1) and Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
1388037|NCT01376323|Secondary|Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12|Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Index||Standard Deviation|Mean
1388038|NCT01376323|Secondary|Change From Baseline in Fasting Insulin at Week 12|Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Picomoles per liter||Standard Deviation|Mean
1388039|NCT01376323|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
1388040|NCT01376323|Secondary|GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship|The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected.|Up to Week 12|PD population. The data for this outcome measure was not collected.||||||
1388041|NCT01376323|Secondary|Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6|Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6.|Baseline (Day 1) and up to Week 6|PD population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
1388042|NCT01376323|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12|Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12.|Baseline (Day -1) and up to Week 12|Pharmacodynamic (PD) population comprised of all participants who provide pharmacodynamic data. Only those participants available at the specified time points were analyzed.|||Percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1388043|NCT01376323|Primary|Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick|Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL).|Up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1388044|NCT01376323|Primary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)|Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided.|Up to Week 12|Safety population|||Participants|||Count of Participants
1388127|NCT01375127|Primary|Number of Participants With Graft Failure|Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
1388046|NCT01376323|Primary|Number of Participants With Abnormal Electrocardiograms (ECGs) Findings|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented.|Up to Week 20|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1388047|NCT01376323|Primary|Change From Baseline in Heart Rate|Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12.|Baseline (pre-dose Day 1) and up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1388048|NCT01376323|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12.|Baseline (pre-dose Day 1) and up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1388049|NCT01376323|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Week 12|Safety population was used which was defined as all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1388050|NCT01376297|Primary|Percentage of Patients With Adverse Events|This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.|Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks|Safety Population|||percentage of patients with TEAE|||Number
1388051|NCT01376245|Secondary|Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168|CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions.|Baseline (BL) and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
1388052|NCT01376245|Primary|Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represents those with data available at the time point being presented, however, all par. in the ITT population without missing covariate information with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1388053|NCT01376167|Secondary|Volume of Distribution (Vc/F) of TQ|Apparent population central volume of distribution of TQ|Day 2, Day 8, Day 15, Day 29 and Day 60|Safety Population|||Liters||90% Confidence Interval|Median
1388054|NCT01376167|Secondary|Oral Clearance (CL/F) of TQ|Apparent population oral clearance of TQ|Day 2, Day 8, Day 15, Day 29 and Day 60|Safety Population|||Liters per hour||90% Confidence Interval|Median
1388055|NCT01376167|Secondary|Number of Participants With Action Taken to Treat Recurrence Episode of P Vivax Malaria|Health outcomes were evaluated based on the actions taken by the participants to treat recurrence episode of P vivax malaria. The reported action taken by site is summarized. Where no action by site have been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Safety Population|||Participants|||Number
1388056|NCT01376167|Secondary|Time Lost by Participants or Care Givers From Normal Occupation|Health outcomes were evaluated based on total time lost by participants or care givers due to an episode of malaria. The reported time lost due to recurrence episode of P vivax malaria has been summarized by category and by site. Where categories by site have not been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Safety Population|||Days|||Number
1388057|NCT01376167|Secondary|Cost Incurred With Purchase of Medications Associated With Recurrence Episode of Malaria|Health outcomes were evaluated based on the cost of medications purchased. The reported total medication cost for paracetamol associated with recurrence episode of P vivax malaria has been reported by site. Where costs have not been reported at a visit, the number of participants analyzed is given as 0. Medications recorded as “Other” and medications without costs are excluded from the analysis. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
1388058|NCT01376167|Secondary|Cost Associated With Recurrence Episode of P Vivax Malaria|Health outcomes were evaluated based on the total costs spent on treatment, transport, medication and tests. The cost was summarized according to the place at which the participant went to for care (drug shop, trial clinic, other clinic, hospital (inpatient/outpatient), traditional healer, other). The reported costs by type and by site has been summarized. Where costs have not been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Safety Population|||US Dollars (USD)||Standard Deviation|Mean
1388059|NCT01376167|Secondary|Number of Participants With Clinical Chemistry Laboratory Data Outside the Reference Range|Blood samples were collected for the evaluation of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk. Phos), Aspartate Aminotransferase (AST), bilirubin, creatine kinase, creatinine, glomerular filtration rate (GFR), indirect bilirubin and urea. The number of participants with clinical chemistry laboratory data outside the extended normal range (F3) was presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Only those participants with data available at the specified data points were analyzed.|Up to Day 120|Safety Population|||Participants|||Number
1388060|NCT01376167|Secondary|Number of Participants With Hematology Laboratory Data Outside the Reference Range|Blood samples were collected for the evaluation of hematology parameters including eosinophils, leukocytes, lymphocytes, neutrophils, platelets, reticulocytes and methemoglobin. The number of participants with hematology laboratory data outside the extended normal range (F3) was presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Only those participants with data available at the specified data points were analyzed.|Up to Day 120|Safety Population|||Participants|||Number
1388061|NCT01376167|Secondary|Number of Participants With TEAEs by Maximum Intensity|An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ). Number of participants with AEs based on severity has been presented.|Up to Day 180|Safety Population|||Participants|||Number
1388062|NCT01376167|Secondary|Number of Participants With TEAEs and Serious TEAEs|An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with possible drug induced liver injury with hyperbilirubinemia. TEAEs is defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ). Number of participants with TEAEs and serious TEAEs have been presented.|Up to Day 180|Safety Population|||Participants|||Number
1388063|NCT01376167|Secondary|Number of Participants With Retinal Changes From Baseline|Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment. The number of participants with definite retinal change and questionable (ques) retinal change from Baseline was presented. Only those participants with data available at the specified data points were analyzed.|Baseline and up to Day 180|Ophthalmic Safety Population. Day 180 was not a required follow up assessment, hence, data was not collected for most participants.|||Participants|||Number
1388064|NCT01376167|Secondary|Incidence of Visual Field Abnormalities Based on Best Corrected Visual Acuity Test Scores|Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Best corrected visual acuity was assessed individually for each eye. Scores were recorded as a ratio. The values were used to derive a logMAR score for statistical analysis where logMAR=-1x log10 (ratio score). The mean and standard deviation of logMAR score for each treatment group has been summarized. High scores were associated with worse vision, and low scores with better vision. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Ophthalmic Safety Population. Day 180 was not a required follow up assessment, hence, data was not collected for most participants.|||logMAR scores||Standard Deviation|Mean
1388105|NCT01375764|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1388065|NCT01376167|Secondary|Number of Participants With Keratopathy|Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. The number of participants displaying keratopathy in each eye was summarized for each visit. The number of participants with new keratopathy at any time post Baseline was also reported. Ophthalmic Safety Population comprised of all participants in the Safety Population who have results from any eye assessments. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Ophthalmic Safety Population. Day 180 was not a required follow up assessment, hence, data was not collected for most participants.|||Participants|||Number
1388066|NCT01376167|Secondary|Number of Participants With Gastrointestinal Disorders|Gastrointestinal tolerability was analyzed by the number of par experiencing gastrointestinal disorders such as abdominal pain, heartburn, diarrhea, constipation, nausea, and vomiting. The number of participants with gastrointestinal disorders for each treatment group has been summarized.|Up to Day 180|Safety Population|||Participants|||Number
1388067|NCT01376167|Secondary|Change From Baseline in Percent Methemoglobin|Methemoglobin assessment was made with the aid of a non-invasive signal extraction pulse CO-Oximeter handheld machine (Masimo). The change from Baseline in percent methemoglobin by treatment, time and sex has been summarized. The last assessment performed prior to the first dose of study medication (CQ or randomized treatment) was considered as Baseline. Change from Baseline was calculated as the post baseline assessment minus the Baseline assessment for percent methemoglobin. Only those participants with data available at the specified data points were analyzed.|Baseline and up to Day 120|Safety Population|||Percent Methemoglobin||Standard Deviation|Mean
1388068|NCT01376167|Secondary|Number of Participants With Acute Renal Failure|There were no participants with acute renal failure in the study.|Up to Day 180|Safety Population|||Participants|||Number
1388069|NCT01376167|Secondary|Number of Participants Who Received Blood Transfusion|The number of participants who received blood transfusion as a result of hemoglobin decline has been summarized.|Up to Day 180|Safety Population|||Participants|||Number
1388070|NCT01376167|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Potentially Related to Hemoglobin Decrease|TEAEs are defined as adverse events (AEs) with an onset date and time on or after that of the start of first dose of study medication (including CQ). The number of participants with TEAEs potentially related to hemoglobin decrease has been presented.|Up to Day 180|Safety Population|||Participants|||Number
1388071|NCT01376167|Secondary|Number of Participants With Hemoglobin Decline From Baseline Over First 29 Days|Glucose-6-phosphate dehydrogenase deficiency (G6PD) deficiency is known to be a risk factor for hemolysis in participants treated with 8-aminoquinolines. Blood samples were collected for the evaluation of hemoglobin levels. Hemoglobin decreases of >=30% or >3 grams/deciliter (g/dL) from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL in the first 15 days of the study were considered as protocol defined serious adverse events (SAEs). Number of participants with maximum hemoglobin decline from Baseline over first 29 days of study has been summarized. Safety Population consisted of all randomized participants who received at least one dose of study medication.|Baseline and up to Day 29|Safety Population|||Participants|||Number
1388072|NCT01376167|Secondary|Time to Fever Clearance|Fever clearance time was defined as time from first dose of treatment to the time when body temperature falls to normal within Study Days 1-4 and remains normal for at least 48 hours up to the Day 8 visit. Fever clearance was considered to have been achieved once an initial temperature of more than 37.40 degree Celsius is reduced to a value less than or equal to 37.40 degree Celsius and in the absence of value more than 37.40 degree Celsius in the following 48 hours up to the Day 8 visit. The time taken to achieve fever clearance was analyzed using Kaplan Meier Methodology. The median fever clearance time along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
1388073|NCT01376167|Secondary|Time to Parasite Clearance|Parasite clearance time was defined as time needed to clear asexual parasite from the blood that is, parasite numbers falling below the limit of detection in the thick blood smear and remaining undetectable after 6 to 12 hours. The time taken to achieve parasite clearance was analyzed using Kaplan Meier Methodology. The median parasite clearance time along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
1388074|NCT01376167|Secondary|Time to Recurrence of P Vivax Malaria|Recurrence was defined as the first confirmed presence of P vivax asexual stage parasites after clearance of initial parasitemia following CQ treatment. Time to recurrence was defined as the time (in days) from initial parasite clearance to recurrence. The time to recurrence was analyzed by the Kaplan-Meier method. NA indicates data was not available due to insufficient number of participants with events during the follow up period in the study. The median number of days to recurrence along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Days||95% Confidence Interval|Median
1388075|NCT01376167|Secondary|Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose|A participant (par) was considered to have demonstrated recurrence-free efficacy at 4 months if: a) Par had non-zero P vivax asexual parasite count at Baseline. b) Par showed initial clearance of P vivax parasitemia. c) Par had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 130 following initial parasite clearance. d) Par did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment after Study Day 109 (up to and including Study Day 130). e) Par is parasite-free at 4 months defined as a negative asexual P vivax parasite count at the first parasite assessment performed after Study Day 109 (up to and including Study Day 130). Par were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites or did not have a 4 month assessment. The number of par with recurrence-free efficacy at 4 months has been summarized.|4 months post dose|mITT Population|||Participants|||Number
1388106|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B /Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1388107|NCT01375751|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputaton was used.|||percent change||Standard Error|Least Squares Mean
1388076|NCT01376167|Primary|Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose|A participant was considered to have demonstrated recurrence-free efficacy at 6 months if: a) Participant had non-zero P vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P vivax parasitemia defined as two negative asexual P vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval. c) Participant had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 201 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment. e) Participant is parasite-free at 6 months. Participants were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites, or did not have a 6 month assessment. The number of participants with recurrence-free efficacy at 6 months has been summarized.|6 months post dose|Microbiologic intent to treat (mITT) Population-all randomized participants who received at least one dose of study medication, who have at least one P vivax parasite assessment after randomization, and who have a positive parasite smear for P vivax at Baseline.|||Participants|||Number
1388077|NCT01376089|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Overall Image Quality rated as ‘Excellent, Adequate or Poor’ by radiologists blinded to the contrast administration.|Ten minutes post contrast administration.||||Number of subject images|||Number
1388078|NCT01376089|Primary|Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration.||||Number of Subjects with discomfort|||Number
1388079|NCT01376089|Primary|Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration||||Number of Subjects with discomfort|||Number
1388080|NCT01376050|Secondary|Change in Ulcer Size|The study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success.|Baseline and 12 Weeks||||cm²||Standard Deviation|Mean
1388081|NCT01376050|Primary|Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups|'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.|Baseline and 12 Weeks||||participants|||Number
1388082|NCT01376037|Primary|Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint|Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).|baseline and 2 weeks||||participants|||Number
1388083|NCT01375946|Secondary|Patch Adhesion|"Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale:~0: >90% adhered (essentially no lift off of the skin)~>75% adhered but <90% (some edges showing lift)~>50% adhered but <75% (half of system lifts off)~<50% (> half of system lifts off, but undetached)~patch completely detached~Patches were assessed prior to patch removal."|6 weeks|Safety population|||Score||Standard Deviation|Mean
1388084|NCT01375946|Primary|Css (48-168) Profile of EE|Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||pg/mL||Standard Deviation|Mean
1388085|NCT01375946|Primary|Steady-state Concentration (Css) (48-168) Profile of LNG|Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||pg/mL||Standard Deviation|Mean
1388086|NCT01375946|Primary|AUC(0-168) Profile of Ethinyl Estradiol (EE)|AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||ng*hr/mL||Standard Deviation|Mean
1388108|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used|||percent change||Standard Error|Least Squares Mean
1388109|NCT01375751|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1388087|NCT01375946|Primary|Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)|AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||ng*hr/mL||Standard Deviation|Mean
1388088|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388089|NCT01375777|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388090|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388091|NCT01375777|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388092|NCT01375777|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
1388093|NCT01375777|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1388094|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388095|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388096|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388097|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388098|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388099|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388100|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388101|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
1388102|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
1388103|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
1388104|NCT01375764|Primary|Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1388110|NCT01375751|Secondary|Absolute Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; LOCF imputation was used.|||mg/dL||Standard Error|Least Squares Mean
1388114|NCT01375660|Secondary|C-Peptidogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. C-peptide circulates in blood in amounts equal to insulin because insulin and C-peptide are linked when first made by the pancreas. C-peptide is more stable in blood than insulin; therefore it can be reliably used to evaluate insulin secretion. It is calculated by a special formula using C-peptide and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.~Insulin secretion was assessed based on formula C-Peptidogenic index-30 [(C-Peptide at 30 min – fasting C-peptide)/(glucose at 30 min – fasting glucose)]Bergstrom RW, Wahl PW, Leonetti DL, Fujimoto WY. Association of fasting glucose levels with a delayed secretion of insulin after oral glucose in subjects with glucose intolerance. J Clin Endocrinol Metab. 1990;71:1447-1453.)"|12 Month||||(ng/mL)/(mg/dL)||Standard Deviation|Mean
1388115|NCT01375660|Secondary|Insulinogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.~Insulin secretion was assessed based on formula Insulinogenic index-30 [(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952)"|12 Month||||(µU/mL)/(mg/dL)||Standard Deviation|Mean
1388116|NCT01375660|Secondary|Insulin Sensitivity by Matsuda Composite|"Insulin Sensitivity by Matsuda Composite – index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS.~Matsuda composite calculated based on formula 10^4/Square Root of [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)]."|12 Months||||10^4/√[(µU/mL)/(mg/dL)x(µU/mL)/(mg/dL)]||Standard Deviation|Mean
1388117|NCT01375660|Secondary|Change in HbA1c From Baseline at 12 Months||Baseline and 12 Months||||percentage of A1C||Standard Deviation|Mean
1388118|NCT01375660|Primary|Oral Glucose Insulin Sensitivity (OGIS)|"Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test.~The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline."|12 months||||ml/min/m^2 of body surface area||Standard Deviation|Mean
1388119|NCT01375608|Primary|The Percentage Change in HbF Level From Baseline to the Average Over the Final 1 Month of Study.||Final 1 month of study||||Participants|||Count of Participants
1388120|NCT01375569|Secondary|Count of Participants With Adverse Events|here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|25 months, 15 days||||Participants|||Count of Participants
1388121|NCT01375569|Primary|Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).|Time to tumor progression is defined as the proportion of participants who are progression free after 4 months on study. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|2 years||||Weeks||Full Range|Mean
1388122|NCT01375374|Secondary|Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||mmol/L||Full Range|Median
1388123|NCT01375374|Secondary|Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||pmol/L||Full Range|Median
1388124|NCT01375374|Secondary|Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||Free Androgen Index||Full Range|Median
1388125|NCT01375374|Primary|Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||nmol/L||Full Range|Median
1388126|NCT01375127|Primary|Number of Participants Who Died||Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
1388128|NCT01375127|Primary|Number of Participants With Central Nervous System (CNS) Infection|Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
1388130|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.|Day 28 to Day 196|Sensitivity Analysis Set|||percentage of participants||95% Confidence Interval|Number
1388131|NCT01375049|Secondary|Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam|The plasma concentration of aztreonam for participants < 6 years of age was obtained 1 hour after the first dose of AZLI on Day 1 and immediately prior to the last dose of AZLI on Day 28.|Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)|Participants in the Full Analysis Set < 6 years of age with evaluable PK profiles were analyzed.|||ng/mL||Standard Deviation|Mean
1388132|NCT01375049|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline to Days 28, 56, 112, and 196|Full Analysis Set|||kg/m^2||Standard Deviation|Mean
1388133|NCT01375049|Secondary|Change From Baseline in Height||Baseline to Days 28, 56, 112, and 196|Full Analysis Set|||cm||Standard Deviation|Mean
1388134|NCT01375049|Secondary|Change From Baseline in Weight||Baseline to Days 28, 56, 112, and 196|Full Analysis Set|||kg||Standard Deviation|Mean
1388135|NCT01375049|Secondary|Use of Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (an indication of PA exacerbation) while on treatment and posttreatment was summarized.|Baseline to Day 196|Full Analysis Set|||percentage of participants|||Number
1388136|NCT01375049|Secondary|Percentage of Participants With PA-negative Cultures|The percentage of participants with a PA-negative culture was summarized at each visit.|Days 28, 56, 112, and 196|Participants from the Full Analysis Set who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course were included in the analysis at all time points.|||percentage of participants|||Number
1388137|NCT01375049|Secondary|Change From Baseline in CFQ-R RSS Score|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) only in participants ≥ 6 years of age. The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1388138|NCT01375049|Secondary|Change From Baseline in FEV1% Predicted|Spirometry assessments were performed only in participants ≥ 6 years of age. Forced expiratory volume in 1 second (FEV1) % predicted was defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex and body composition.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.|||percentage of FEV1% predicted||Standard Deviation|Mean
1388139|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.|Day 28 to Day 196|Evaluable Analysis Set|||percentage of participants||95% Confidence Interval|Number
1388140|NCT01374971|Secondary|Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment|The DAS 28 ESR is a score calculated from the results of a 28-count joint assessment (total number of tender joint possible is 28, and total number of swollen joints possible is 28), the Erythrocyte Sedimentation Rate (ESR), and the Patient Global Assessment (measured using a 100 mm visual analogue scale, with the lowest possible score of 0 mm meaning the subject is not affected at all by arthritis and the highest possible score of 100 mm meaning the subject is severely affected by arthritis). A lower DAS 28 ESR indicates less active disease, and a higher DAS 28 ESR indicates more active disease. The DAS 28 ESR was calculated for each subject at the screening visit and at the Week 14 final visit. The percent change was then calculated for each patient, and a mean percent change for all subjects was determined.|Screening and Week 14||||percent change||Standard Deviation|Mean
1388141|NCT01374971|Primary|Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis|Synovial tissue biopsy samples were taken at baseline and at 12 weeks after starting treatment with CZP. These samples were analyzed to determine the concentrations of select biomarkers and to determine the percent change in concentration from baseline to week 12.|Baseline and Week 12||||Percent change||95% Confidence Interval|Geometric Mean
1388142|NCT01374919|Secondary|Number of Participants With Treatment Related Serious Adverse Events. Calls for Minor Side Effects Will Occur at 24 and 48 Hours and One Week. A Followup Visit Will Occur at 4 Weeks.||immediate, 24 and 48 hours, one week and followup visit at 4 weeks||||participants|||Number
1388143|NCT01374919|Primary|Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.|Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8|baseline 4 weeks and 8 weeks|Two patients had minor infusion reactions and refused rechallenge. All other patients completed the study. Their hemoglobin levels, the primary outcome, were obtained at 4 and 8 weeks.|||percentage of participants|||Number
1388144|NCT01374906|Secondary|Actual Change in SF-12v2 Score From Baseline - Physical Component Summary|SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.|Months 7, 12 & 24|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
1388145|NCT01374906|Secondary|Actual Change in SF-12v2 Score From Baseline - Mental Component Summary|SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.|Months 7, 12 & 24|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
1388146|NCT01374906|Secondary|Actual Change in Standardized Score of Cushing’s Disease HRQoL (CushingQOL) Score From Baseline|CushingQol is a disease-specific patient-reported outcome instrument. It is a single-domain 12 item Cushing's disease quality of life instrument. The Cushing’s syndrome quality of life (CushingQoL) questionnaire is a single domain questionnaire which includes 12 self-report items scored using a five point Likert scale anchored at (1=always/very much and 5=never/not at all). The patient is asked to report what they think or feel about their Cushing’s syndrome and how much the illness has interfered in usual activities over the past 4 weeks. The total score is standardized on a 0-100 scale with lower scores indicating a greater impact on quality of life.|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
1388147|NCT01374906|Secondary|Pharmacokinetic (PK) Parameter: Cmax|"Pasireotide peak levels (Cmax) was one of the parameters used for PK assessments. Cmax is the post-dose PK concentration with an elapsed time from the previous injection of 21+/-2 days. All patients randomized to the study had at least one PK observation and were therefore included in the pharmacokinetic analysis set (PAS). Cmax PK observations (Day 20 and Day 104) with an elapsed time from the previous injection outside of 21+/-2 days window were excluded. Given that SOM230 LAR was administered once a month, the Cmax were collected every 28 days in this study, thus this provides a summary of Cmax values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose and not an arm/group. Patients randomized to either the 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study."|Days 22, 106, 190|"Pharmacokinetic analysis set (PAS): The PAS consists of all randomized patients who have received at least one dose of study drug and had at least one post dosing PK assessment.~Patients were analyzed according to incident dose (defined as the last dose prior to the PK sample)."|||ng/mL||Standard Deviation|Mean
1388148|NCT01374906|Secondary|Pharmacokinetic (PK) Parameter: Ctrough|Pasireotide trough levels (Ctrough) was 1 of the parameters used for PK assessments. Ctrough is the pre-dose PK concentration with an elapsed time from previous injection of 28+/-2 days. All patients randomized to the study had at least 1 PK observation & were therefore included in the pharmacokinetic analysis set. PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28 ±2 days window were excluded. Given that SOM230 LAR was administered once a month, Ctrough was collected every 28 days and thus this provides a summary of Ctrough values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose & not an arm/group. Patients randomized to either 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study.|Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337|"Pharmacokinetic analysis set (PAS): The PAS consists of all randomized patients who have received at least one dose of study drug and had at least one post dosing PK assessment.~Patients were analyzed according to incident dose (defined as the last dose prior to the PK sample)."|||ng/mL||Standard Deviation|Mean
1388149|NCT01374906|Secondary|Percent of Participants With a Duration of at Least 50% Reduction in mUFC From Baseline at Indicated Time Points|Duration of 50% reduction from baseline is defined as the period starting from the date of patient’s first 50% reduction from baseline|Months 6, 12 & 18|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1388150|NCT01374906|Secondary|Percent of Participants Attaining a Time to First Achievement of at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points|Time to first achievement of a 5by randomized groups.0% reduction in mUFC from baseline|every month in the core phase and every 3 months in the extension phase) up to and including the cut-off date for the Month 12 CSR (10-Nov-2015)|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1388151|NCT01374906|Secondary|Percentage of Patients That Attain a Reduction of at Least 50% in mUFC From Baseline|"All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.~Analysis split by screening strata of mUFC~Stratum 1:"|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1388152|NCT01374906|Secondary|Percentage of Participants That Attained a Mean Urinary Free Cortisol (mUFC) <= 1.0 x Upper Limit of Normal (ULN) at Month 7 Regardless of Dose Up-titration at Month 4.|"All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.~Analysis split by screening strata of mUFC Stratum 1: mUFC 1.5x to < 2.0 x ULN Stratum 2: mUFC 2.0x to <= 5.0 x ULN"|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1388412|NCT01372605|Secondary|Health Care Costs|Total health care costs over 12 months|12 months|All participants were analyzed using all available time points, with multiple imputation used to address missing data.|||dollars||Standard Error|Mean
1388153|NCT01374906|Secondary|Percentage of Participants Having a Favorable Shift From Baseline in Clinical Signs|This includes patients with improvements in symptoms from baseline. Clinical signs over time include: facial rubor, fat pads, hirsutism, striae, (via photographs by a second local physician who was blinded to the treatment dose and time point of the photograph) and muscle strength.|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants|||Number
1388154|NCT01374906|Secondary|Percentage Change From Baseline in Clinical Signs Over Time|Percentage change in parameter measurements: blood pressure, body mass index, waist circumference, fasting serum lipid profile, weight, bone density and body composition (examined by DXA scan) from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage change||Standard Deviation|Mean
1388155|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Cholesterol & Triglycerides|Change in parameter measurements: cholesterol & triglycerides from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||mmol/L||Standard Deviation|Mean
1388156|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Waist Circumference|Change in waist circumference measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||cm||Standard Deviation|Mean
1388157|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Body Composition: Region|Change in body composition: region measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage fat||Standard Deviation|Mean
1388158|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Weight|Change in weight measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||kg||Standard Deviation|Mean
1388159|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Body Mass Index (BMI)|Change in BMI measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||kg/m2||Standard Deviation|Mean
1388160|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Blood Pressure|Change in blood pressure measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1388161|NCT01374906|Secondary|Percentage Change From Baseline on Serum Cortisol Over Time|Percentage change in serum cortisol (nmol/L) from Baseline by randomized groups.|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage change||Standard Deviation|Mean
1388162|NCT01374906|Secondary|Percentage Change From Baseline on Plasma Adrenocorticotropic Hormone (ACTH) Over Time|Percentage change in ACTH (pmol/L) from Baseline by randomized groups.|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage change||Standard Deviation|Mean
1388163|NCT01374906|Secondary|Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points|Duration of controlled or partially controlled response is defined as the period starting from the date of patient’s first normalization (mUFC≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient’s mUFC >1.0 x ULN and the reduction from baseline falls to less than 50% for the first time.|Month 6, 12, 18|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1388164|NCT01374906|Secondary|Percent of Participants Attaining a mUFC ≤ 1.0 x ULN or at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points|Time to first achievement of attaining a mUFC ≤ 1.0 x ULN or at least a 50% reduction in mUFC from baseline by randomized groups.|Momth 7, Month 12|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1388165|NCT01374906|Secondary|Percentage of Patients With Uncontrolled Response at Month 7 & Month 12 Within the Subset of Patients Who Had Uncontrolled Response at a) Months 1 and 2; b) Months 1, 2, and 3|Percentage of patients with mUFC > 1.0 xULN at Month 7 and Month 12 within the subset of patients who were uncontrolled at a) Months 1 & 2, b) Months 1, 2, & 3 by randomized groups.|Month 7, Month12|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
1388166|NCT01374906|Secondary|Percentage of Patients Who Are Controlled Responders (mUFC ≤ 1.0 xULN) on at Least 4 of the 7 mUFC Assessments by Month 7 & on at Least 7 of the 12 mUFC Assessments by Month 12.|Percentage of patients with mUFC ≤ 1.0 x ULN at a minimum of 4 months up to and including Month 7, and at a minimum of 7 months up to and including Month 12 by randomized groups.|Month 7, Month 12|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1388167|NCT01374906|Secondary|Percentage of Patients Who Attain mUFC ≤1.0 x ULN or Have at Least 50 % Reduction From Baseline in mUFC|Controlled responder: mUFC ≤ 1.0×ULN. Partially controlled responder: at least 50% reduction in mUFC from Baseline, and mUFC >1.0×ULN.|M7, M12, M24, M36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1388168|NCT01374906|Secondary|Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN|Controlled responder: mUFC ≤ 1.0×ULN by randomized groups.|M7, M12, M24, M36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1388169|NCT01374906|Secondary|Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline|Percentage change in mUFC (nmol/24h) from baseline by randomized groups.|M7, M12, M24, M36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage change||Standard Deviation|Mean
1388170|NCT01374906|Secondary|Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline|Actual change in mUFC (nmol/24h) from baseline by randomized groups.|baseline, Month 7 (M7), Month 12 (M12), Month 24 (M24) , Month 36 (M36)|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||nmol/24h||Standard Deviation|Mean
1388171|NCT01374906|Secondary|Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4|"Percentage of participants that attain a mUFC ≤ 1.0×ULN at Month 7 and had not had a dose increase at Month 4. Patients who had a dose increase prior to Month 7 were counted as non-responders in this analysis.~Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.~A responder was defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4."|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1388172|NCT01374906|Primary|Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration|Percentage of participants that attained a mean urinary free cortisol (mUFC) <= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1388173|NCT01374802|Secondary|Tmax,ss of Darunavir|time from last dosing to maximum concentration of the analyte in plasma at steady state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set|||h||Full Range|Median
1388174|NCT01374802|Primary|Cmax,ss of Darunavir|maximum measured concentration of the analyte in plasma at steady-state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1388175|NCT01374802|Primary|Cτ,ss of Darunavir|concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1388176|NCT01374802|Primary|AUCτ,ss of Darunavir|"area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1388177|NCT01374568|Primary|Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo|Bone turnover assessed using change in bone-specific alkaline phosphatase (BAP) over 8 weeks of treatment.|8 WEEKS|The difference between the bone turnover markers bone alkaline phosphatase (BAP) from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study.|||mg/L||Standard Deviation|Mean
1388178|NCT01374568|Primary|Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo.|Bone turnover assessed using change in TRACP5b over 8 weeks of treatment.|8 weeks|The difference between the bone turnover markers TRACP5b from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study. As a result we were unable to analyze the 2 participants with missing data.|||U/L||Standard Deviation|Mean
1388179|NCT01374451|Secondary|Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg||Cycle 1 Day 21, Cycle 2 Day 29|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||ng/mL||Standard Deviation|Mean
1388180|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Tmax||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||hr||Inter-Quartile Range|Median
1388181|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||ng/mL||Standard Deviation|Mean
1388182|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for CL/F||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||L/hr||Standard Deviation|Mean
1388183|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for AUClast||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||ng*hr/mL||Standard Deviation|Mean
1388184|NCT01374451|Secondary|Disease Control Rate (DCR) as Per Radiology Review|Disease control rate is the percentage of patients with a best overall response of CR or PR or stable disease (SD) determined by the local radiologist according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.0. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). PD: Any progression ≤ 18 weeks after randomization (and not qualifying for CR, PR or stable disease SD.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.|||Percentage of participants||95% Confidence Interval|Number
1388432|NCT01372202|Secondary|Time to Disease Progression|To determine time to disease progression with this treatment strategy.|3 years|||||||
1388433|NCT01372202|Secondary|Survival|To determine the survival outcome with this treatment strategy.|3 years|||||||
1388185|NCT01374451|Secondary|PFS and the Predictive Probability of Success in Phase III|105 PFS events expected after approximately 36 months|Once 105 PFS events had occurred occurred|Since the study was terminated because the study did not meet its primary objective which was based on PFS as per local radiology assessment, minimal efficacy data was obtained. Only 80 PFS events occurred before study was terminated so 105 PFS events was not reached to analyze this data.||||||
1388186|NCT01374451|Secondary|Overall Survival (OS) Using Kaplan Meier Method|Overall survival was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was to be censored at the date of last contact.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.|||Percentage of participants||95% Confidence Interval|Number
1388187|NCT01374451|Secondary|Duration of Response (DoR)|80 PFS are expected after approximately 24 months. Kaplan Meier was initially planned to be used to depict duration of response by treatment group and by stratum. Later based on the mode of action of everolimus and pasireotide and based on study experience, only a low number of objective responses per RECIST were expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients. Only a low number of objective responses per RECIST was expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.||||||
1388188|NCT01374451|Secondary|Objective Response Rate (ORR) as Per Radiology Review|"Objective response was determined by the local radiologist according to the RECIST Version 1.0. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). This is also referred to as Overall response rate.~CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline."|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.|||Percentage of participants||95% Confidence Interval|Number
1388189|NCT01374451|Secondary|Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR|Consisted of monitoring and recording the rate, type, severity, and causal relationship of adverse events (AEs) and serious AEs (SAEs) to treatment. The safety analysis was based mainly on the frequency of AEs or SAEs and on the number of laboratory values that fell outside of pre-determined range.|Once 80 PFS events had occurred|"Safety analysis population included all patients who received any study medication (i.e. at least 1 dose of the study drug in case of monotherapy or at least 1 dose of any 1 compound of the study treatment in case of a combination therapy) with a post-Baseline safety assessment.~See Adverse Events (AE) section for all AEs collected."|||Participants|||Number
1388190|NCT01374451|Primary|Progression-free Survival (PFS) Per Local Radiological Review|PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.|Once 80 PFS events had occurred aproximately after 24 months|"The FAS consisted of all randomized patients. Following the intention to treat principle patients were analyzed according to the treatment (and stratum) they were assigned to at randomization.~One patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems."|||months||95% Confidence Interval|Median
1388191|NCT01374438|Secondary|Change From Baseline in HMW Adiponectin of MSDC-0160 or Placebo Over 12 Weeks|Estimate the effect of 150 mg daily MSDC-0160 versus placebo on levels of high molecular weight adiponectin. Increases in HMW adiponectin suggest improved insulin sensitivity.|Days 1(baseline) and 91||||micromol/L||Standard Deviation|Mean
1388192|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Estimate With the Executive Function Scale|Estimate of the effect of 3-months of MSDC-0160 treatment versus placebo on a 9-item executive function scale. A summary measure of executive function was constructed by converting raw scores from 9 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the executive function tests at both study time points.|||z-score||Standard Deviation|Mean
1388193|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Determined by the ADAS-Cog Subscale|Alzheimer’s Disease Assessment Scale – Cognitive Subscale, an assessment of cognitive ability. Scores on 11 individual tasks were summed to produce the reported total score, with a possible range of 0 (no impairment) to 70 (severe impairment).|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the ADAS-Cog tests at both study time points.|||Scores on a scale||Standard Deviation|Mean
1388194|NCT01374438|Secondary|Change From Baseline in Global Cognitive Function Tests|Change from baseline in cognitive function, as determined by global cognitive function on a neuropsychological battery of 19 tests, following 3 months treatment with MSDC-0160 versus placebo. A summary measure of global cognitive function was constructed by converting raw scores from 19 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91||||z-scores||Standard Deviation|Mean
1388381|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement.|Day 7|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
1388195|NCT01374438|Primary|Effects of MSDC-0160 on Cerebral Metabolic Glucose Rate or Placebo Over 12 Weeks in Pre-specified Regions of Interest Analysis Referenced to Cerebellum|Investigate the effect of 150 mg daily MSDC-0160 vs placebo on 3-month change in brain glucose utilization using FDG-PET pre-specified regions of interest analysis referenced to cerebellum, including five bilateral regions: posterior cingulate, parietal cortex (angular gyrus), lateral temporal cortex, medial temporal cortex, and anterior cingulate-medial frontal cortex. Results are reported as Standardized Uptake Value Ratios. A change from baseline in the metabolic rate of glucose that is ≥0 indicates maintenance of brain glucose utilization, whereas values <0 indicate a decline in brain glucose utilization.|Days 1(baseline) and 91|Intent-to-treat|||Ratio||Standard Deviation|Mean
1388196|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388197|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388198|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388199|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388200|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388201|NCT01374425|Secondary|OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388202|NCT01374425|Secondary|OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388203|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388204|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388205|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388206|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388207|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388208|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388216|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388209|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388210|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1388211|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1388212|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388213|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388214|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388215|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1|Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1388217|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388218|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
1388219|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1|Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1388220|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388221|NCT01374425|Secondary|OS in Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388222|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388223|NCT01374425|Secondary|Overall Survival (OS)|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|ITT Population|||months||95% Confidence Interval|Median
1388224|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388225|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388226|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388227|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388228|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388229|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388230|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388231|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
1388304|NCT01374087|Secondary|Overall Survival|"Overall survival was defined as the time in months from diagnosis (biopsy date for local recurrence) to death due to any cause, the last visit or the loss to follow-up.~No deaths were reported during the study. As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|5 years|||||||
1404194|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96.|Week 96|ITT-E Population|||Participants|||Number
1388232|NCT01374425|Primary|Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm). Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|Intent-to-treat (ITT) Population|||months||95% Confidence Interval|Median
1388233|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||participants|||Number
1388234|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||participants|||Number
1388235|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|4 weeks||||participants|||Number
1388236|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||Days||Standard Deviation|Mean
1388237|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||Days||Standard Deviation|Mean
1388238|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|4 weeks||||Days||Standard Deviation|Mean
1388239|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|6 weeks before starting||||Days||Standard Deviation|Mean
1388240|NCT01374269|Secondary|Treatments Associated With Low Back Pain at 6 Months|we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.|6 months||||participants|||Number
1388241|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||percentage of participants|||Number
1388242|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||percentage of participants|||Number
1388243|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388244|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388245|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|At the beginning||||units on a scale||Standard Deviation|Mean
1388246|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|4 weeks||||units on a scale||Standard Deviation|Mean
1388247|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388248|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388249|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|4 weeks||||units on a scale||Standard Deviation|Mean
1388250|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|At the beginning||||units on a scale||Standard Deviation|Mean
1388251|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388252|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388253|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|4 weeks||||units on a scale||Standard Deviation|Mean
1388254|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|At the beginning||||units on a scale||Standard Deviation|Mean
1388255|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388434|NCT01372202|Primary|Pathological Complete Response|CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.|3 years||||Participants|||Count of Participants
1388256|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388257|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|4 weeks||||units on a scale||Standard Deviation|Mean
1388258|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|At the beginning||||units on a scale||Standard Deviation|Mean
1388259|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388260|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388261|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|4 weeks||||units on a scale||Standard Deviation|Mean
1388262|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|At the beginning||||units on a scale||Standard Deviation|Mean
1388263|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1389608|NCT01361854|Primary|Failure Rate of Sleep Study|"failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as poor or unsatisafctory according to Redline et al. SLEEP 1998 are considered as failed."|1 day||||percentage of participants|||Number
1388264|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388265|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|4 weeks||||units on a scale||Standard Deviation|Mean
1388266|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|At the beginning||||units on a scale||Standard Deviation|Mean
1388267|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388268|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388269|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|4 weeks||||units on a scale||Standard Deviation|Mean
1388270|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|At the beginning||||units on a scale||Standard Deviation|Mean
1388271|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1389609|NCT01361633|Secondary|Implicit Memory Task|Assesses implicit memory for anxious and neutral words|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1388272|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388273|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|4 weeks||||units on a scale||Standard Deviation|Mean
1388274|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|At the beginning||||units on a scale||Standard Deviation|Mean
1388275|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388276|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388277|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|4 weeks||||units on a scale||Standard Deviation|Mean
1388278|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|At the beginning||||units on a scale||Standard Deviation|Mean
1388279|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1389202|NCT01364584|Secondary|Echocardiographic Measures - Circumferential Strain|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||% difference in circumferences||Standard Deviation|Mean
1388280|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388281|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|4 weeks||||units on a scale||Standard Deviation|Mean
1388282|NCT01374269|Primary|Visual Analogue Scale of Pain|The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388283|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388284|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.|4 weeks||||units on a scale||Standard Deviation|Mean
1388285|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|At the beginning||||units on a scale||Standard Deviation|Mean
1388286|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388287|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388288|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|4 weeks||||units on a scale||Standard Deviation|Mean
1388289|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a ‘Yes’ / ‘No’ option. If patients indicate in any way that an item is not applicable to them, the item is scored ‘No’, i.e. the denominator remains 24. Being worst 24.|At the beginning||||units on a scale||Standard Deviation|Mean
1388305|NCT01374087|Secondary|BFFS Percentage 5 Years From Treatment Initiation|"A subject had a biochemical failure if there was an increase of PSA of 2 ng/mL or more in comparison with the pre-study nadir PSA confirmed in the course of follow-up by a second value after 3 or more weeks or with diagnosis of a new clinical recurrence of their prostate cancer over the 5-year follow-up.~As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|5 years|||||||
1388290|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
1388291|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
1388292|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|4 weeks||||units on a scale||Standard Deviation|Mean
1388293|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|At the beginning||||units on a scale||Standard Deviation|Mean
1388294|NCT01374269|Primary|Visual Analogue Scale of Pain|In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.|At the beginning||||units on a scale||Standard Deviation|Mean
1388295|NCT01374178|Secondary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.|Baseline up to 30 days|All randomized participants were included in the analysis.|||participants|||Number
1388296|NCT01374178|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data.|||hour (h)||Full Range|Median
1388297|NCT01374178|Secondary|Total Glucose Infused (Gtot)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.|||gram (g)||Geometric Coefficient of Variation|Geometric Mean
1388298|NCT01374178|Secondary|Maximum Glucose Infusion Rate (Rmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.|||grams per hour (g/h)||Geometric Coefficient of Variation|Geometric Mean
1388299|NCT01374178|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.|||picomole per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1388300|NCT01374178|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)|AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.|Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.|||picomole*hour per liter (pmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
1388301|NCT01374087|Secondary|Quality of Life (QoL) Modifications (Spanish Version of the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire)|"EPIC assessed the disease-specific aspects of prostate cancer and its therapies and comprised four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supported dividing the Urinary Domain Summary Score into two different Incontinence and Irritative/Obstructive subscales. In addition, each Domain Summary Score had measurable Function Subscale and Bother Subscale components. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.~As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|At every visit (except for Visit 2 (treatment administration visit))|||||||
1388302|NCT01374087|Secondary|Change in PSA Levels|"Blood samples were to be drawn for serum PSA at study initiation, and then at 3, 6, 12, 18, 24, 30, 36, 48 and 60 months.~As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|5 years|||||||
1388303|NCT01374087|Secondary|Change in Total Testosterone Level|"Blood samples were drawn for serum testosterone at study initiation, and then at 3, 6 and 12 months.~As the study was prematurely terminated, no data analyses were conducted. The study was terminated prior to completion of the 5-year follow-up."|12 months|||||||
1389610|NCT01361633|Secondary|Stroop|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1388306|NCT01374087|Secondary|Time to Progression|"Time to progression (in months) was measured from the informed consent date to the date of first event occurrence. Progression was defined as either: death from all causes or disease progression (defined as PSA increased by 2 ng/mL as compared to the pre-trial nadir PSA, confirmed during follow-up by a second value after 3 or more weeks, or the diagnosis of a new clinical recurrence of their prostate cancer (metastasis, new injury, etc.)).~As the study was prematurely terminated, no analyses were conducted. Data for time to progression are listed by subject for those individuals who reported progression."|5 years|A total of 3 subjects in the brachytherapy group and 4 subjects in the brachytherapy + triptorelin 22.5 mg group reported treatment failure. The subject numbers assigned in the study are not presented. The subjects with progression are listed as Subjects 1 to 7, with these bearing no relation to the subject numbers used for other endpoints herein.|||Time to progression (Months)|||Number
1388307|NCT01374087|Primary|Biochemical Failure-free Survival (BFFS)|"BFFS was determined by a Prostate Specific Antigen (PSA) increase of 2 ng/mL or more in comparison with the pre-study nadir PSA (as per the Phoenix criteria) confirmed in the course of follow-up by a second value 3 weeks later or longer over the 5-year follow-up. Time to BFFS was defined from the “start date” to the first time when PSA increase of 2 mL was observed.~As the study was prematurely terminated, no analyses were conducted. Data for BFFS are listed by subject for those individuals who reported biochemical failure. Time (months) to biochemical failure is relative to the date of brachytherapy."|5 years|A total of 3 subjects in each treatment group reported biochemical failure. The subject numbers assigned in the study are not presented. The subjects with biochemical failure are listed as Subject 1 to Subject 6, with these bearing no relation to the subject numbers used for other endpoints herein.|||Months to Biochemical Failure|||Number
1388308|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by weight at the time of hospital discharge (approximately 5 weeks)|approximately 5 weeks||||g||Standard Deviation|Mean
1388309|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by growth velocity at 28 days of age|28 days of age||||g/d||Standard Deviation|Mean
1388310|NCT01373918|Secondary|Mortality Rate|death|at the end of the hospital stay which is expected to be an average of 5 weeks||||participants|||Number
1388311|NCT01373918|Primary|Presence of Cholestasis|Cholestasis will be defined by a direct bilirubin > 2 mg/dL|prior to 100 days of life, hospital discharge, or death whichever comes first||||participants|||Number
1388312|NCT01373671|Primary|Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone|The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.|1 year|Per protocol 300 subjects were selected for analysis based on 89% power & 5% type one error rate determination.|||unitless|breasts|Standard Error|Mean
1388313|NCT01373580|Secondary|Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye|Less than 5% of participants should have postoperative manifest refractive astigmatism in the implanted eye that increases from baseline by greater than 2.00 D at 6 months postoperative and all subsequent visits.|At 6 months postoperative and all subsequent visits|Numbers analyzed at each timepoint differ due to participant availability.|||Count of Participants|||Number
1388314|NCT01373580|Secondary|Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye|Less than 5% of participants should lose more than two lines of best corrected distance and near visual acuity in the implanted eye; and less than 1% of participants with preoperative best spectacle corrected visual acuity (BCDVA) of 20/20 in the implanted eye should have best corrected distance and near visual acuity worse than 20/40 in the implanted eye at 6 months postoperative and all subsequent visits.|at 6 months postoperative and all subsequent visits|Numbers analyzed at each timepoint differ due to participant availability|||Count of Participants|||Number
1388315|NCT01373580|Primary|Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye|75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline|24 Months||||Count of Participants|||Number
1388316|NCT01373489|Primary|Hemoglobin A1c (HbA1c) at 6 Months Post Randomization|Hemoglobin A1c (HbA1c) at 6 months post randomization|6 months post randomization|Final analysis used baseline A1c analysis of covariance for differences in levels of A1c at 6 months between the treatment groups with baseline A1c as covariate.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1388317|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR) and hence determine ISR/G.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in placebo n = 18.|||ISR (ng/min) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
1388324|NCT01373346|Secondary|Hemoglobin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of hemoglobin after operation in good responder group for the evaluation of long-term safety.|||g/dl||Standard Deviation|Mean
1388318|NCT01373450|Secondary|Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in a placebo n = 18.|||mg/dL||Standard Deviation|Least Squares Mean
1388319|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment|The reproducibility of insulinotrophic effects was compared after two separate placebo treatment periods within the same treatment sequence. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single subcutaneous dose of placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Over these two treatment periods glucose (G), insulin and C-peptide levels were measured from blood collected at the highest glucose infusion rate; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR), and hence to determine the insulinotrophic effect, ISR/G.|Baseline and 160 minutes after start of GGI at each placebo treatment period|Participants within the same treatment sequence who were treated with Placebo in two separate treatment periods. Participants treated with Oxyntomodulin or Liraglutide were not analyzed for this outcome measure.|||ISR (ng/mg) / Glucose (mg/dL)||Standard Deviation|Mean
1388320|NCT01373450|Primary|Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM|Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G).|Baseline and up to160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.|||ISR (ng/mL) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
1388321|NCT01373450|Primary|Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.|||mg/dL||Standard Deviation|Least Squares Mean
1388322|NCT01373450|Primary|Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)|Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes.|Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.|||mg/dL||Standard Deviation|Least Squares Mean
1388323|NCT01373346|Secondary|Albumin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of albumin level after operation for the evaluation of long-term safety in good responder group.|||g/dl||Standard Deviation|Mean
1388395|NCT01372774|Secondary|Change in Quality-of-life at 6 Months|Clinically significant change in quality of life is defined as ten-point change on QOL scores (transformed to a 0 to 100 scale). As measured by the overall score from the FACT-Br. An improvement is defined as a change greater than or equal ten points.|Up to 6 months post randomization|Only patients with baseline and 6 month QOL assessment scores were included in this analysis.|||participants|||Number
1388325|NCT01373346|Secondary|HbA1c : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of HbA1c after operation in good response group.~HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)~The HbA1c was calculated as a ratio to total hemoglobin."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HbA1c after operation in good responder group."|||percentage of glycated hemoglobin||Standard Deviation|Mean
1388326|NCT01373346|Secondary|Body Mass Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of weight change after operation in good response group.~BMI(Body Mass index , kg/㎡) was measured.~BMI was obtained using the following formula:~Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of weight after operation in good responder group."|||kg/㎡||Standard Deviation|Mean
1388327|NCT01373346|Secondary|HOMA-B : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.~HOMA-B was obtained using the following formula:~225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of beta cell function after operation in good responder group."|||percentage of beta cell function||Standard Deviation|Mean
1388328|NCT01373346|Secondary|HOMA-IR : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin resistance after operation in good response group.~HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.~HOMA-IR was obtained using the following formula:~Glucose(mg/dl) x Insulin/405"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HOMA-IR after operation in good responder group."|||units on a scale||Standard Deviation|Mean
1388329|NCT01373346|Secondary|QUICKI : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.~The QUICKI is obtained using the following formula:~1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of QUICKI after operation in good responder group."|||units on a scale||Standard Deviation|Mean
1388330|NCT01373346|Secondary|Matsuda Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group.~The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:~Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of insulin sensitivity after operation in good responder group."|||units on a scale||Standard Deviation|Mean
1388331|NCT01373346|Primary|Operation Related Mortality|Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.|Until end of study (on average 14.8 months)|All of enrolled patient were included.(N=15)|||participants|||Number
1388332|NCT01373346|Primary|Albumin|For the evaluation of long-term safety, albumin was measured to determine malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.|||g/dl||Standard Deviation|Mean
1388333|NCT01373346|Primary|Hemoglobin|For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.|||g/dl||Standard Deviation|Mean
1388334|NCT01373346|Primary|HbA1c|"For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).~HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin."|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||percentage of glycated hemoglobin||Standard Deviation|Mean
1388335|NCT01373346|Secondary|Body Mass Index|"BMI(Body Mass index , kg/㎡) was measured.~BMI was obtained using the following formula:~Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||kg/㎡||Standard Deviation|Mean
1388336|NCT01373346|Secondary|HOMA-B|"HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.~HOMA-B was obtained using the following formula:~225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||percentage of beta cell function||Standard Deviation|Mean
1388337|NCT01373346|Secondary|HOMA-IR|"HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.~HOMA-IR was obtained using the following formula:~Glucose(mg/dl) x Insulin/405"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||units on a scale||Standard Deviation|Mean
1388338|NCT01373346|Secondary|QUICKI|"The quantitative insulin sensitivity check index (QUICKI) was measured.~The QUICKI was obtained using the following formula:~1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation , 6 months after operation , Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||units on a scale||Standard Deviation|Mean
1388339|NCT01373346|Primary|Morbidity|"For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected.~*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.~Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix “d” (for ‘disability’) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.~For the evaluation of long-term safety, the patients were evaluated every month after discharge."|Until end of study (on average 14.8 months)|All of enrolled patient were included. (N=15)|||participants|||Number
1388340|NCT01373346|Secondary|Matsuda Index|"Matsuda Index(Insulin Sensitivity Index) was measured.~The Matsuda index was obtained using the following formula:~Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||units on a scale||Standard Deviation|Mean
1388341|NCT01373294|Other Pre-specified|Comparison of the Correlative Assay|For comparing the correlative assay results of ever-relapsers vs non-relapsers, the combined data with the monotherapy and combination therapy groups would be applied. The participants would be categorized based on 1-year relapse.|1 year post disease response|||||||
1388342|NCT01373294|Other Pre-specified|Effect of Addition of Revlimid on Cytokines|The immunologic impact of the addition of Revlimid™ to BCG for secondary prevention of non-muscle-invasive transitional cell bladder cancer, in terms of a panel of correlative assays. The effect of addition of Revlimid on cytokines associated with generation of immune response and on cytotoxic T lymphocytes and memory phenotype lymphocytes.|Duration of study treatment and follow-up - average of 12 months|||||||
1388343|NCT01373294|Secondary|Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|Number of participants with treatment emergent AEs or SAEs per category. SAEs will be specifically labeled as such. Participants were assessed at monthly intervals (corresponding to Revlimid™ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated.|Duration of study treatment and follow-up - average of 12 months|All participants.|||participants|||Number
1388344|NCT01373294|Primary|Arm A: Progression Free Survival (PFS)|The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison|1 year|Experimental Arm A Group Only.|||participants|||Number
1388345|NCT01373281|Primary|Density Incidence of Symptomatic Virologically Confirmed Dengue Cases Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|"Symptomatic virologically-confirmed dengue (VCD) cases were defined as acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmed by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Cases defined as number of subjects with at least one symptomatic VCD episode from 28 days post-injection 3 to the end of Active Phase.~Density incidence: data are cases per 100 person-years at risk. Data presented is the sum of individual units of time for which the participants contributed to the analyses. Incidence density was calculated as the number of VCD cases divided by the cumulative person-years at risk."|28 days and up to 14 months post-injection 3|Density incidence of symptomatic virologically confirmed dengue cases were assessed in the Per-Protocol Analysis Set.|||Cases per 100 person-year at risk|||Number
1388346|NCT01373281|Primary|The Person-years at Risk for Participants With Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|The person-years at risk was the cumulative time (in years) until the participant was diagnosed with VCD or until the end of the active period, whichever came first. Data presented is the sum of individual units of time for which the participants contributed to the analyses. Incidence density was calculated as the number of VCD cases divided by the cumulative person-years at risk. The vaccine efficacy is considered as significant if the lower bound of its 95% CI (exact method by Breslow & Day) is greater than 25%.|28 days and up to 14 months post-injection 3|Vaccine Efficacy Against Symptomatic Virologically confirmed Dengue Cases were assessed in the Per-Protocol Analysis Set.|||Cumulative time (in years) until VCD|||Number
1388347|NCT01373281|Secondary|Percentage of Subjects With Solicited Injection-site and Systemic Reactions Following Any and Each Injection With CYD Dengue Tetravalent Vaccine|Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited injection site reactions (12-14 years): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 Solicited injection site reactions: Fever, ≥39°C; Headache, Malaise, Myalgia, and Asthenia, Significant, prevents daily activity.|Day 0 up to Day 14 post each vaccination|Solicited injection site reactions and systemic reactions were assessed in a subset of the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Percentage of participants|||Number
1388348|NCT01373281|Secondary|Percentage of Flavi Virus-Immuned Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07)|Antibody titers against each dengue virus serotype strain were assessed in the Per-Protocol Analysis Set for Immunogenicity population, i.e. those who received vaccine 3 doses in the Immunogenicity subset only.|||Percentage of participants|||Number
1388349|NCT01373281|Secondary|Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With CYD Dengue Tetravalent Vaccine|Geometric mean titers against each serotypes of the Dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) in a pre-defined subset of 2,000 subjects from each country (1,333 in the CYD Dengue Vaccine Group and 667 in the Control Group).|Pre-vaccination 1 and Day 28 post each vaccination up to 25 months (visit 07)|Antibody titers against each dengue virus serotype strain were assessed in a subset of the Full Analysis Set for Immunogenicity (FASI), subjects who received at least one dose of vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1388350|NCT01373281|Primary|Number of Symptomatic Virologically Confirmed Dengue Cases (Vaccine Efficacy) Due to Any Serotype During the Active Phase Post-dose 3 Injection With CYD Dengue Vaccine|"Symptomatic virologically-confirmed dengue (VCD) cases were defined as acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmed by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Cases defined as number of subjects with at least one symptomatic VCD episode from 28 days post-injection 3 to the end of Active Phase.~The vaccine efficacy is considered as significant if the lower bound of its 95% CI (exact method by Breslow & Day) is greater than 25%."|28 days and up to 13 months post-injection 3|Number of symptomatic virologically confirmed dengue cases were assessed in the Per-Protocol Analysis Set.|||Cases per 100 person-years at risk|||Number
1388351|NCT01373229|Secondary|Reduction in the Frequency of Blood and Platelet Transfusions|The change in number of transfusions from pre- to post-treatment will be calculated and summarized across all patients by giving the minimum, the 25th, 50th (median) and the 75th percentile and the maximum.|4 weeks prior to therapy and in the 4 weeks following the completion of therapy|Data were not collected and the Outcome will never be analyzed||||||
1388352|NCT01373229|Secondary|Reduction in Severity of B Symptoms|Reduction in the severity of the following B symptoms will be assessed: fever ≥ 101F, chills, night sweats, and anorexia with weight loss.|at the end of stage 1 (lenalidomide alone), at the end of stage 2 (4 months of combination), and at 2 months post-completion of therapy|Data were not collected and the Outcome will never be analyzed||||||
1388353|NCT01373229|Secondary|Overall Survival (OS)||the time from day 1 of treatment to death or 2 years, whichever comes first|Subjects who died on study|||months||Standard Deviation|Mean
1388354|NCT01373229|Secondary|Progression-free Survival (PFS)||time from day 1 of treatment to disease progression, death, or 2 years, whichever comes first|Subjects who experienced disease progression|||months||Standard Deviation|Mean
1388365|NCT01373164|Secondary|Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|Phase 1b: All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1388355|NCT01373229|Secondary|Overall Response (Complete Response/Partial Response)|"NCI 96 Response Criteria~CR (Complete Response):~Lymphadenopathy = none > 1.5cm Hepatomegaly = none Splenomegaly = none Blood lymphocytes = <4000 per microliter Marrow = normocellular, <30% lymphocytes, no B-lymphoid nodules. Platelet count = >100,000 per microliter Hemoglobin = >11.0 grams per deciliter Neutrophils = >1500 per microliter~PR (Partial Response):~Lymphadenopathy = Decrease >/= 50% Hepatomegaly = Decrease >/= 50% Splenomegaly = Decrease >/= 50% Blood lymphocytes = Decrease >/= 50% from baseline Marrow = 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count = >100,000 per microliter or increase >/= 50% over baseline Hemoglobin = >11.0 grams per deciliter or increase >/= 50% over baseline Neutrophils = >1500 per microliter or increase >/= 50% over baseline"|at the end of 4 months of combination treatment and at 2 months after completion of therapy|Three (3) subjects were unable to complete the run-in phase. Three (3) subjects died prior to completing stage 2, and three (3) subjects were unable to complete 4 cycles of combination therapy. Therefore, only 6 subjects were analyzed for response.|||Participants|||Count of Participants
1388356|NCT01373229|Primary|Maximum Tolerated Dose||4-16 months||||mg/kg|||Number
1388357|NCT01373164|Secondary|Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up|Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. The outcome measure is the median, minimum and maximum values from participants who had samples collected at baseline and at follow-up|Baseline, study treatment completion after first follow up visit (up to 1 year)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for CA19-9 level.|||Units/Milliliter (U/mL)||Full Range|Median
1388358|NCT01373164|Secondary|Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion|The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions that included assessing average pain in the past 24 hours.|Baseline, study treatment completion (up to 1 year)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for BPI-sf.|||Units on a scale||Standard Deviation|Mean
1388359|NCT01373164|Secondary|Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||ng/mL||Inter-Quartile Range|Mean
1388360|NCT01373164|Secondary|Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])|AUC[0-24] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||mg*h/L||Inter-Quartile Range|Mean
1388361|NCT01373164|Secondary|Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline to measured progressive disease (up to 2 years)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for ORR.|||Percentage of Participants||95% Confidence Interval|Number
1388362|NCT01373164|Secondary|Phase 2: Percentage Change From Baseline in Tumor Size (CTS)|Change in tumor size is defined as the maximum percent change from baseline in the sum of target lesions. Change was assessed in each participant using radiographic imaging.|Baseline, end of Cycle 2 (up to 56 days)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for change in tumor size.|||Percent change in tumor size||95% Confidence Interval|Geometric Mean
1388363|NCT01373164|Secondary|Phase 2: Progression Free Survival (PFS)|PFS is defined as the date of randomization to the first date of progression of disease or of death from any cause. For each participant who is not known to have died or to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, PFS will be censored at the date of last prior contact. PFS will be calculated and analyzed twice: (1) including clinical progressions of disease not based on lesion measurements, and (2) excluding clinical progressions. Progression Disease (PD) was defined as having at least a 25% increase in the sum of the longest diameter of target lesions.|Baseline to first date of progressive disease or death due to any cause (up to 2 years)|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 21 and Placebo + Gemcitabine = 11.|||Months||95% Confidence Interval|Median
1388364|NCT01373164|Secondary|Phase 1b: Number of Participants With Tumor Response|Response was defined using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to end of Phase 1b (up to 1 year)|Phase 1b: All participants who received at least one dose of study drug.|||Participants|||Number
1388396|NCT01372774|Secondary|Time to CNS Failure in These Patients||Up to 5 years post radiation||||Months||95% Confidence Interval|Median
1406616|NCT01206465|Secondary|Number of Participants With Polymorphisms in Methylenetetrahydrofolate Reductase and Thymidylate Synthase||Prior to the first dose of protocol therapy||||percentage of patients|||Number
1388366|NCT01373164|Secondary|Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)|AUC[0-24h] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. AUC0-infinity will take 48h and extrapolation beyond this in addition to earlier time points to be calculated. All mentioned time points are used to calculate the two AUCs.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|Phase 1b: All participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1388367|NCT01373164|Primary|Phase 2: Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.|Baseline to date of death from any cause (up to 2 years)|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 20 and Placebo + Gemcitabine = 4.|||Months||95% Confidence Interval|Median
1388368|NCT01373164|Primary|Phase 1b: Recommended Phase 2 Dose|The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from Phase 1b.|Time of first phase 1b dose until time of last phase 1b dose (up to 1 year)|Phase 1b: All participants who received at least one dose of study drug.|||milligrams (mg)|||Number
1388369|NCT01372995|Secondary|Day 84 Mortality|The number of participants who died prior to the end of the study (Day 84) was collected.|Day 84|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11, as one participant withdrew.|||participants|||Number
1388370|NCT01372995|Secondary|Number of Hospital Mortality Cases|The number of study participants who died while in the hospital was collected.|12 weeks|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11.|||participants|||Number
1388371|NCT01372995|Secondary|Number of Hospital Acquired Infections|The number of study participants who had a hospital acquired infection.|12 weeks||||participants|||Number
1388372|NCT01372995|Secondary|Change in Sequential Organ Failure Assessment (SOFA) Score|Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score.|Baseline, Day 7|SOFA score obtained daily while in the ICU. The portion of the study participants included in the analysis of the change in SOFA score between Baseline and Day 7 is limited to participants having values for both time points..|||units on a scale||Standard Deviation|Mean
1388373|NCT01372995|Secondary|Duration of Time in Hospital|The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported.|12 weeks||||days||Standard Deviation|Mean
1388374|NCT01372995|Secondary|Duration of Time in Intensive Care Unit (ICU)|The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported.|12 weeks||||days||Standard Deviation|Mean
1388375|NCT01372995|Secondary|Duration of Time on Ventilator|The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported.|12 weeks||||days||Standard Deviation|Mean
1388376|NCT01372995|Secondary|Change in Plasma LL-37 Levels|Plasma LL-37 was measured at Baseline, Day 7 and Day 14.|Baseline, Day 7, Day 14|For the Day 14 analysis there were 8 participants in the Placebo arm, 6 participants in the 250,000 of Vitamin D arm, and 5 participants in the 500,000 of Vitamin D arm.|||ng/mL||Inter-Quartile Range|Median
1388377|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement.|Day 84|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
1388378|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement.|Day 28|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
1388379|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement.|Day 21|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
1388380|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement.|Day 14|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed for each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
1388382|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.|Baseline|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. At the baseline time point, 10 patients were randomized to the placebo arm, 9 to the arm receiving 250,000 IU of Vitamin D3, and 11 to the arm receiving 500,000 of Vitamin D3.|||participants|||Number
1388383|NCT01372878|Secondary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference|Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.|1 year, same as study duration||||percentage of participants||95% Confidence Interval|Number
1388384|NCT01372878|Primary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference|"Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.~Sensitivity measures the proportion of actual positives which are correctly identified as such.~Specificity measures the proportion of negatives which are correctly identified as such.~positive event defined as patients with polyps ≥6 mm detected by OC procedure."|1 year, same as study duration||||percentage of participants||95% Confidence Interval|Number
1388385|NCT01372813|Secondary|Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib)|If an adequate number of responses were seen, the relation of these responses to the presence/absence of inactivating VHL mutations in tumor tissue would have been assessed.|12 months|Not enough samples for meaningful analysis.||||||
1388386|NCT01372813|Secondary|The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density|Tumor tissue sections were to be stained with hematoxylin and eosin (H and E) and endothelial cell markers at baseline and specified timepoints following initiation of therapy (when tumor tissue was available)|12 months|Not enough samples for meaningful analysis.||||||
1388387|NCT01372813|Secondary|Tumor Tissue Used to Evaluate Von Hippel-Lindau (VHL) Status and/or Components of the Vascular Endothelial Growth Factor (VEGF)/Epidermal Growth Factor Receptor (EGFR) Pathway|Components of the VEGF and EGFR pathways were to be evaluated using Western blot analysis at baseline and specified timepoints following initiation of therapy when tumor tissue was available.|12 months|Not enough samples for meaningful analysis.||||||
1388388|NCT01372813|Secondary|Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|Flow dynamics within specific tumor sites will be evaluated based on the results of the DCE-MRI obtained first without contrast enhancement and then after contrast enhancement. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters previously defined (Ktrans, Kep, etc.).|12 months||||Participants with changes|||Number
1388389|NCT01372813|Secondary|Number of Circulating Endothelial Cells (CEC) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEC cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.||||||
1388390|NCT01372813|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11.5 months||||Participants|||Number
1388391|NCT01372813|Secondary|Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Progression free survival is defined as the time from initiation of treatment to either progression or death.~RECIST evaluates tumor response. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For detailed information about RECIST, see the protocol Link module."|12 months||||Days||95% Confidence Interval|Median
1388392|NCT01372813|Secondary|Number of Circulating Endothelial Progenitor Cells (CEP) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEP cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.||||||
1388393|NCT01372813|Secondary|Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2)|Plasma VEGFR and VEGFR2 would have been measured using the (enzyme-linked immunosorbent assay)ELISA at baseline and specified timepoints following initiation of therapy.|12 months|Not enough samples for meaningful analysis.||||||
1388394|NCT01372813|Primary|Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR))|Clinical response is the best response recorded from the start of treatment until disease progression. Clinical response is assessed by the Response Evaluation in Solid Tumors (RECIST) criteria. A partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. A complete response (CR) is the disappearance of all target lesions.|12 months||||Participants|||Number
1388410|NCT01372605|Secondary|Number of Participants With Viral Load Below Detection|HIV RNA viral load below the limit of detection at 6 months|6 months|All participants with a viral load available at 6 months. Some individuals without a viral load at 6 months still continued in the study and provided later data.|||participants|||Number
1388397|NCT01372774|Secondary|Local Control of the Surgical Bed|Local control of the surgical bed means that tumor did not recur at the unresected metastases treated with stereotactic radiosurgery, SRS, or whole brain radiotherapy, WBRT. Intercranial Brain Control Rates estimated via 1-Cumulatice Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Up to 6 months post radiation||||percentage of patients||95% Confidence Interval|Number
1388398|NCT01372774|Primary|Overall Survival|To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Overall survival is defined as the time from randomization to death from any cause.|from baseline up to 5 years post radiation|All enrolled patients were included in the analysis of this outcome. This includes the 9 patients that did not receive treatment.|||months||95% Confidence Interval|Median
1388399|NCT01372774|Primary|Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT|To determine in patients with one to four brain metastases whether there is less nuerocognitive progression post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Neurocognitive progression is defined as a drop of at least one stanard deviation from baseline in one of the six neurocognitive tests at post-randomization evaluation.|from baseline up to 5 years post radiation|All enrolled patients were included in the analysis of this outcome. This includes the 9 patients that did not receive treatment.|||Months||95% Confidence Interval|Median
1388400|NCT01372748|Secondary|Percentage of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.||||percentage of participants|||Number
1388401|NCT01372748|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA).|||participants|||Number
1388402|NCT01372618|Secondary|Hyperglycemia|In our previous study, we found that women had moderately increased blood sugar early after starting SOM230. In other studies in normal individuals this effect disappeared by a week or two. We found some evidence of improvement during administration. However, extending the treatment period from 9.5 to 19.5 days will enable us to make certain that the early elevated sugar associated with SOM230 is only temporary.|Before and after 20 days of treatment with 3 month post-treatment follow-up|PI death. Study terminated||||||
1388403|NCT01372618|Secondary|Effect of SOM 230 / Pasireotide on Tumor Volume and Tumor Kinetics|To determine whether pasireotide prevents angiogenesis in DCIS as it does in the rat mammary gland, we will immunostain tissue samples for Factor VIII to identify vessels in DCIS before and after treatment. Further, using dynamic contrast enhanced MRI (DCE-MRI) we plan to detect changes in angiogenesis in vivo, non-invasively, and also detect effects of pasireotide which theoretically should inhibit vascularity. We propose to evaluate changes in the size of the lesion, changes in the morphologic appearance and kinetic features of the lesion.|Before and after 20 days of treatment|PI death. Study terminated||||||
1388404|NCT01372618|Primary|Cell Proliferation and Apoptosis|Tissue from initial diagnostic breast biopsies will be compared to the remaining tissue excised after treatment with SOM230. Tissue will be stained to measure cell proliferation and apoptosis (cell death).|Before and after 20 days of treatment|PI death. Study terminated||||||
1388405|NCT01372605|Secondary|Depression-free Days|Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months|12 months|All participants with at least one depression measure contributed to this analysis.|||days||Standard Deviation|Mean
1388406|NCT01372605|Secondary|Safety Endpoint|Psychiatric hospitalizations|12 months||||participants|||Number
1388407|NCT01372605|Secondary|Self-reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|12 months|All participants completing the 12-month interview contributed data to this analysis. Some participants did not complete the 12-month interview but still completed the study and contributed other data.|||units on a scale||Standard Deviation|Mean
1388408|NCT01372605|Secondary|Self Reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|6 months|All participants completing the 6-month interview and currently on antiretrovirals contributed to this analysis. Some participants did not complete the 6-month interview but still continued in the study and contributed to later data.|||units on a scale||Standard Deviation|Mean
1388409|NCT01372605|Secondary|Quality of Life|Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.|6 months|All participants who completed a 6-month research interview contributed data to this endpoint. Some participants did not complete the 6-month interview but still continued in the study and contributed later data.|||units on a scale||Standard Deviation|Mean
1389611|NCT01361633|Secondary|Trails B|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1388413|NCT01372605|Secondary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor|12 months|Includes all individuals who completed a 6-month pill count that could be linked to an earlier (usually, 5-month) pill count, so as to calculate adherence. Some individuals did not complete this data point but still continued in the study and contributed later data.|||Percentage of expected pills||Standard Deviation|Mean
1388414|NCT01372605|Secondary|Depressive Symptoms|Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.|Six months|All those completing a 6-month outcomes interview which resulted in a valid HAMD measure|||units on a scale||Standard Deviation|Mean
1388415|NCT01372605|Primary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor|Six months post-enrollment|All those completing a 6-month pill count which resulted in a valid adherence measure|||observed pills taken as % of expected||Standard Deviation|Mean
1388416|NCT01372501|Secondary|Change in Absolute Weight Loss From Baseline to Week 52||Week 52|Per Protocol Population (n=14); subjects who had the device implanted for 52 weeks.|||kg||Standard Deviation|Mean
1388417|NCT01372501|Primary|Assessment of the % Excess Weight Loss at Week 52 or Last Assessment|Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2|52 Weeks|Full Analysis Set (FAS) population had a device successfully implanted.|||%EWL||Standard Deviation|Mean
1388418|NCT01372462|Secondary|Borg Dyspnea Score During Constant Workrate Exercise at Isotime|"Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome.~0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome"|Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N|Per Protocol|||units on a scale||Standard Deviation|Mean
1388419|NCT01372462|Secondary|SpO2 During Constant Workrate Exercise at Isotime|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg|Per Protocol|||percentage of oxyHb saturation||Standard Deviation|Mean
1388420|NCT01372462|Primary|Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.|Per protocol analysis|||minutes||Standard Deviation|Mean
1388421|NCT01372410|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 8 is defined as the value obtained 24 hours after the morning dose administered on Day 7. Analysis was performed using a mixed model with covariates of mean Baseline, period Baseline, treatment, and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each particiapant. Change from Baseline for each treatment period is the trough FEV1 at Day 8 minus the Baseline value for that treatment period.|Baseline and Day 8 of each treatment period (up to Study Day 50)|mITT Population. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 8.|||Liters||Standard Error|Least Squares Mean
1388422|NCT01372410|Primary|Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. β-FEV1MB-S0 is defined as the covariate (Baseline trough FEV1) effect on the mean Baseline trough FEV1 estimate (S0). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.|||fraction of mean estimated Baseline FEV1|||Number
1388423|NCT01372410|Primary|Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. ED50 is defined as the potency and is the dose that yields 50% of Emax (maximum predicted FEV1 response). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.|||micrograms||95% Confidence Interval|Geometric Mean
1388455|NCT01371994|Secondary|Average Daily Pad Usage at Baseline|Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.|Baseline (7 days prior to Day 1)|Full analysis set with available pad usage data at Baseline.|||pads||Standard Deviation|Mean
1388424|NCT01372410|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours After the Morning Dosing on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour post-dose measurements at Day 7 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 23, and 24 hours. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the weighted mean FEV1 at Day 7 minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 7.|||Liters||Standard Error|Least Squares Mean
1388425|NCT01372410|Secondary|Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period|Serial FEV1 for once daily dosing is recorded at the pre-AM dose (AMD; time 0 hour [h]) and at 1, 3, 6, 9, 12,13, 15, 23, and 24 hours after the AMD on Day 7. For twice daily dosing, the 12 h AMD corresponds to the pre-PM dose (PMD), the 13 h AMD corresponds to the 1 h PMD, the 15 h AMD corresponds to the 3 h PMD, the 23 h AMD corresponds to the 11 h PMD, and the 24 h AMD corresponds to the 12 h PMD in this table. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, period, time, time by period BL interaction, time by mean BL interaction, and time by treatment interaction as fixed effects and participant as a random effect. BL is the value recorded pre-dose on Day 1 of each TP, mean BLis the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each timepoint within a TP is the serial FEV1 measure at that timepoint minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.|||Liters||Standard Error|Least Squares Mean
1388426|NCT01372410|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate trough FEV1dose response. The Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed separately and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. The fixed-effects parameters of the dose response model include Emax (the maximum predicted FEV1 response), ED50 (potency), and S0 (estimated Baseline FEV1). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Data for Emax and S0 are reported in this table. mITT=Modified Intent-to-Treat; par.=participants; BL=Baseline.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.|||Liters||95% Confidence Interval|Geometric Mean
1388427|NCT01372384|Secondary|Overall Survival|The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|The ITT population included all patients with at least one valid post-baseline assessment.|||Days||Full Range|Median
1388428|NCT01372384|Secondary|Safety: Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|All participants who received at least one dose of study medication and had a safety assessment performed post baseline were included in the safety population. Participants were analyzed according to the first dose received during the study.|||participants|||Number
1388429|NCT01372384|Secondary|Objective Response Rate (Investigator Assessed)|Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.|Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)|The ITT population included all patients with at least one valid post-baseline assessment. Only those participants available at the specified time points were analyzed (represented by n=X).|||Percentage||95% Confidence Interval|Number
1388430|NCT01372384|Primary|Progression-free Survival (Tumour Assessments According to RECIST Criteria)|Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.|Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.|The Intent-to-treat (ITT population) included all patients with at least one valid post-baseline assessment.|||Days||Inter-Quartile Range|Median
1388431|NCT01372202|Secondary|Esophageal Tumor CHFR Methylation and Detection in Plasma|To determine the agreement between tumor CHFR methylation and detection in plasma.|3 years|||||||
1388435|NCT01372150|Secondary|Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population|||Percentage of Participants|||Number
1388436|NCT01372150|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|ITT Population|||Percentage of Participants|||Number
1388437|NCT01372150|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Baseline and Week 8|ITT Population|||Score on a Scale||Standard Error|Mean
1388438|NCT01372150|Primary|Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Baseline and Week 8|Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.|||Score on a Scale||Standard Error|Mean
1388439|NCT01371994|Secondary|Time From Baseline to First Day of Returning to Work|The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.|From Baseline to Week 12|Full analysis set participants who were employed prior to the study.|||days||95% Confidence Interval|Median
1388440|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant’s assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||Percent activity impairment||Standard Error|Least Squares Mean
1388441|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants with available WPAI data at Baseline.|||percent activity impairment||Standard Deviation|Mean
1388442|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant’s assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||percent overall work impairment||Standard Error|Least Squares Mean
1388443|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.|||percent overall work impairment||Standard Deviation|Mean
1388444|NCT01371994|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant’s assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||percent impairment while working||Standard Error|Least Squares Mean
1388521|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030|||Percentage of participants|||Number
1388445|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.|||percent impairment while working||Standard Deviation|Mean
1388446|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||Percent work time missed||Standard Error|Least Squares Mean
1388447|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.|||percent work time missed||Standard Deviation|Mean
1388448|NCT01371994|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline and Week 12|"Full analysis set with available ICIQ-SF data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Error|Least Squares Mean
1388449|NCT01371994|Secondary|International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline|Full analysis set with available ICIQ-SF QOL data at Baseline.|||units on a scale||Standard Deviation|Mean
1388450|NCT01371994|Secondary|Change From Baseline in American Urology Association Quality of Life (QOL) Score|"The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUA data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Error|Least Squares Mean
1388451|NCT01371994|Secondary|American Urology Association Quality of Life (QOL) Score at Baseline|The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).|Baseline|Full analysis set with available AUA QOL data at Baseline.|||units on a scale||Standard Deviation|Mean
1388452|NCT01371994|Secondary|Change From Baseline in American Urology Association Symptom Score (AUASS)|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUASS data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Error|Least Squares Mean
1388453|NCT01371994|Secondary|American Urology Association Symptom Score (AUASS) at Baseline|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst)."|Baseline|Full analysis set with available AUASS data at Baseline.|||units on a scale||Standard Deviation|Mean
1388454|NCT01371994|Secondary|Change From Baseline in Average Daily Pad Usage|"Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Weeks 4, 8 and 12|"Full analysis set with available pad usage data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||pads||Standard Error|Least Squares Mean
1388456|NCT01371994|Secondary|Percentage of Participants Who Gain Continence During 12-week Treatment Period|"Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period.~End of treatment is the last on-treatment assessment during the treatment period."|Weeks 4, 8, and 12|Full analysis set; the calculation of percentage of participants uses the full analysis set as the denominator at each time point.|||percentage of participants|||Number
1388457|NCT01371994|Primary|Time From First Dose to Urinary Continence|Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.|12 weeks|Full analysis set defined as all randomized participants who took at least one dose of study drug and had at least one efficacy endpoint evaluation.|||days||95% Confidence Interval|Median
1388458|NCT01371877|Secondary|Number of Participants With Adverse Events|Unit of Measure is Safety and Tolerability. The number of participants with adverse events will be compared between the groups using the independent sample t-test (assuming the distribution is normal).|3 month study trial|No significant adverse events. All subjects in the high vitamin D3 group completed the study; 4 subjects in the low vitamin D3 600 IU/day withdrew from the study (1 for pregnancy and 3 unknown). There was no evidence of hypercalcemia.|||participants|||Number
1388459|NCT01371877|Secondary|Total Urticaria Severity Score at 3 Months|The Unit of Measure is Efficacy. The Total Urticaria Severity Score (USS) ranges from 0 to 93, higher scores = worse symptoms. This secondary outcome of this study is to determine if high dose vitamin D supplementation improves the urticaria severity score (USS). The change in USS will be compared between the groups using the independent sample t-test (assuming the distribution is normal). Logistic regression and multiple linear regression will be used to adjust for possible confounders.|3 month intervention||||units on a scale||Standard Error|Mean
1388460|NCT01371877|Primary|Medication Usage|The Unit of Measure is Efficacy. The primary outcome of this study is to determine if vitamin D supplementation reduces the medication usage in subjects with CUA. Thus, for the outcome of reduction in pills, at 12 weeks, subjects whose pill usage decreases by 2 or more pills per day will be classified as improved. Subjects whose pill consumption did not change or increased will be classified as unchanged.|12 week intervention||||number of pills/day||Standard Deviation|Mean
1388461|NCT01371851|Primary|Change in Psychostimulant-positive Urines Over Time|Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.|twice-weekly urine samples (8 weeks)|Those eligible participants who received at least one dose of study medication.|||proportion of psychostimulant-pos urines|Participants|Standard Deviation|Mean
1388462|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in ME Population||21-42 days after last dose of study drug|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations|||Participants|||Number
1388463|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population||21-42 days after last dose of study drug|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).|||Participants|||Number
1388464|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population||21-42 days after last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome). For this measure only patients who were cured at TOC could be assessed for relapse.|||Participants|||Number
1388465|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population||21-42 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. For this measure only patients who were cured at TOC could be assessed for relapse.|||Participants|||Number
1388466|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population||7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).|||Participants|||Number
1388467|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.|||Participants|||Number
1388468|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.|||Participants|||Number
1388494|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||percentage of participants||95% Confidence Interval|Number
1388469|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).|||Participants|||Number
1388470|NCT01371838|Secondary|Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.|||Participants|||Number
1388471|NCT01371838|Secondary|Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.|||Participants|||Number
1388472|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in ME Population||7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.|||Participants|||Number
1388473|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in mMITT Population||7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).|||Participants|||Number
1388474|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.|||Participants|||Number
1388475|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in CE Population||Last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).|||Participants|||Number
1388476|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in MITT Population||Last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.|||Participants|||Number
1388477|NCT01371838|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population|Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome|7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).|||Participants|||Number
1388478|NCT01371825|Secondary|Percentage of Subjects Achieving Transfusion-free Hemoglobin Normalization|The percentage of subjects achieving transfusion-free hemoglobin normalization (TFHN) of ≥ 4 weeks at any time during the study (also referred to as short-term TFHN), and the percentage of subjects who maintained TFHN for ≥ 13 weeks beginning at Week 6 (also referred to as sustained early TFHN). A subject was considered to have achieved short-term TFHN if the/she had two post-baseline measurements of hemoglobin, obtained at least 4 weeks apart, that were above the age-adjusted lower limit of normal (LLN), and had no additional hemoglobin measurements below LLN during this minimum 4-week period and no transfusions administered during the minimum 4-week period or for 2 weeks prior to the start of this period.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Analysis Set (PES) who received treatment with sebelipase alfa for at least 4 weeks (and could therefore be assessed for short-term TFHN). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.|||percentage of subjects|||Number
1388479|NCT01371825|Secondary|Change in Serum Ferritin|Change from baseline in serum ferritin|from week 0 to week 1|Subjects in the Primary Efficacy Analysis Set (PES) with available data at both baseline and week 1. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.|||change from baseline (µg/L)||Full Range|Median
1388480|NCT01371825|Secondary|Changes in Serum Transaminases|Change from baseline for alanine aminotransferase (ALT) and aspartate aminotransferase (AST)|from week 0 to weeks 1 and 4|Subjects in the Primary Efficacy Analysis Set (PES) with available data at both baseline and week 1 (or week 4). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.|||Change from baseline (U/L)||Full Range|Median
1388495|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||percentage of participants||95% Confidence Interval|Number
1388481|NCT01371825|Secondary|Dichotomous Growth Status Indicators|The percentages of subjects meeting criteria for each dichotomous indicator of under nutrition, i.e., underweight (at least 2 SD below median for weight-for-age [WFA]), wasting (at least 2 SD below median for weight-for-length or -height [WFL/WFH]), and stunting (at least 2 SD below median for length- or height-for-age [LFA/HFA])|Month 12 of treatment|Subjects in the Primary Efficacy Analysis Set (PES) with available anthropometric data at Month 12 of treatment as of the data cut-off date (10 June 2014). The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.|||percentage of subjects|||Number
1388482|NCT01371825|Secondary|Effect on Growth Parameters (Weight-for-age)|Changes from baseline in percentiles for weight-for-age (WFA)|from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Analysis Set (PES) who had growth failure at baseline and who survived beyond week 4 of treatment. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.|||subjects|||Number
1388483|NCT01371825|Secondary|Median Age at Death||from week 0 to data cut-off (27 to 164 weeks of treatment)|Subjects in the Primary Efficacy Ananlysis Set (PES) who died. The PES included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.|||months||Full Range|Median
1388484|NCT01371825|Secondary|Percentage of Subjects in the PES Surviving at 24 Months of Age|The percentage of subjects in the Primary Efficacy Analysis Set (PES) who survived to at least 24 months of age.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. Non-evaluable subjects (n=4) were defined as subjects who were alive, still in the study, and had not yet reached 24 months of age.|||percentage of subjects|||Number
1388485|NCT01371825|Secondary|Percentage of Subjects in the PES Surviving at 18 Months of Age|The percentage of subjects in the Primary Efficacy Analysis Set (PES) who survived to at least 18 months of age.|from week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. Non-evaluable subjects (n=3) were defined as subjects who were alive, still in the study, and had not yet reached 18 months of age.|||percentage of subjects|||Number
1388486|NCT01371825|Primary|Percentage of Subjects in the PES Surviving to 12 Months of Age|The primary efficacy endpoint was the percentage of subjects (%) in the Primary Efficacy Analysis Set (PES) who survived to at least 12 months of age.|From week 0 to data cut-off (27 to 164 weeks of treatment)|Evaluable subjects in the Primary Efficacy Analysis Set (PES), which included subjects who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. All 9 subjects were evaluable.|||% of subjects||95% Confidence Interval|Number
1388487|NCT01371786|Secondary|Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8, and 10 minutes post dose|Scinitigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
1388488|NCT01371786|Secondary|Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
1388489|NCT01371786|Secondary|Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8 and 10 minutes post dose|Scinitgraphic Population|||percentage of of radiolabled||Standard Deviation|Mean
1388490|NCT01371786|Secondary|Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
1388491|NCT01371786|Primary|Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post dose|Scintigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
1388492|NCT01371747|Secondary|Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||percentage of participants||95% Confidence Interval|Number
1388493|NCT01371747|Secondary|Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||Days||95% Confidence Interval|Median
1388496|NCT01371747|Secondary|Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days||Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Deviation|Mean
1388497|NCT01371747|Secondary|Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Deviation|Mean
1388498|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Day 3 were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Day 3|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Error|Least Squares Mean
1388499|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Week 8/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Error|Least Squares Mean
1388500|NCT01371747|Primary|Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group|Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Error|Least Squares Mean
1388501|NCT01371734|Secondary|Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Higher score = more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population n is the number of participants with non-missing values|||Percentage of Participants|||Number
1388502|NCT01371734|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score equals (=) more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population n is the number of participants with non-missing values|||Percentage of Participants|||Number
1388503|NCT01371734|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Mean change from baseline was adjusted for the baseline total score, age group and gender.|Baseline and Week 8|ITT Population n is the number of participants with evaluable data.|||Score on a scale||Standard Error|Least Squares Mean
1388504|NCT01371734|Primary|Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.|Baseline and Week 8|"Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.~n is the number of participants with evaluable data."|||Score on a scale||Standard Error|Least Squares Mean
1388505|NCT01371721|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Percentage of Participants|||Number
1388506|NCT01371721|Primary|Percentage of Participants Experiencing a Treatment Emergent Adverse Event||Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031.|||Percentage of Participants|||Number
1388522|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030|||Percentage of participants|||Number
1388908|NCT01368081|Primary|Number of Patients With Drug Related Adverse Events|Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients|||participants|||Number
1388507|NCT01371721|Secondary|Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Percentage of Participants|||Number
1388508|NCT01371721|Secondary|Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Percentage of Participants|||Number
1388509|NCT01371721|Secondary|Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Score on a Scale||Standard Deviation|Mean
1388510|NCT01371721|Secondary|Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Score on a Scale||Standard Deviation|Mean
1388511|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Percentage of participants|||Number
1388512|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Percentage of participants|||Number
1388513|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Percentage of participants|||Number
1388520|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Units on a scale||Standard Deviation|Mean
1388566|NCT01370837|Primary|Induration Size as a Response to Intracutaneous Candida Albicans.||48 hours after injection.||||millimeters||95% Confidence Interval|Median
1388514|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Percentage of participants|||Number
1388515|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Percentage of participants|||Number
1388516|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing “very much improved” and 7 representing “very much worse”; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Percentage of participants|||Number
1388517|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Units on a scale||Standard Deviation|Mean
1388518|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases|The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Units on a scale||Standard Deviation|Mean
1388519|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Units on a scale||Standard Deviation|Mean
1388523|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms|Clostridium Difficile Associated Disease (CDAD) is defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher.|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
1388524|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms|Musculoskeletal conditions included at least one occurrence of arthralgia, arthritis, gait abnormality or tendinopathy.|Enrollment, 2 months and 12 months post infection observation period|Evaluable patients who submitted musculoskeletal Case Record Form (CRF) combined from both Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) cohorts at enrollment. Ineligible and withdrew of Consent prior to treatment were excluded.|||Percentage of patients|||Number
1388525|NCT01371656|Secondary|Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms||Up to 60 days after enrollment or receiving levofloxacin|Evaluable patients combined from both AL and HSCT cohorts were reported. Ineligible and withdrew of Consent prior to Tx were excluded.|||Percentage of patients|||Number
1388526|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Severe Infection Between Arms|Severe infection defined as any grade 4 or 5 CTCAE catheter-related infection, enterocolitis, lung infection, sepsis, small intestine infection and other infections or infestations|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
1388527|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms|Fever and febrile neutropenia defined as Absolute Neutrophil Count (ANC) < 1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >= 38 degrees C (100.4 degrees F) for more than one hour.|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
1388528|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms|Exposure to antibiotics was considered during the infection observation period(s) was defined a priori as follows: Gram positive agents = vancomycin, linezolid, daptomycin or quinupristin/dalfopristin; Aminoglycosides = amikacin, gentamicin or tobramycin; Third or fourth generation cephalosporins = cefepime, ceftazidime, ceftriaxone or cefotaxime; Empiric antibiotics for fever and neutropenia = imipenem, meropenem, cefepime, ceftazidime or piperacillin/tazobactam|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
1388529|NCT01371656|Primary|Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms|A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
1388530|NCT01371643|Secondary|Percentage of Responders (Only Including Surgical Failures in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months||||percentage of participants||95% Confidence Interval|Number
1388531|NCT01371643|Primary|Percentage of Responders (All Treatments)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months||||percentage of participants||95% Confidence Interval|Number
1388532|NCT01371643|Primary|Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months||||percentage of participants||95% Confidence Interval|Number
1388533|NCT01371565|Primary|Number of Participants With Adverse Events|Safety was assessed at all visits and adverse events were recorded.|6 months|Due to the small number of patients enrolled (N=4), no formal assessments were planned. All patients who received study drug were included in the safety review.|||participants|||Number
1388534|NCT01371552|Primary|"Percentage of Participants Responding Yes"|The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.|Part 2: Day 7|This reporting group includes all participants who completed Part 2.|||Percentage of participants|||Number
1388535|NCT01371552|Primary|Lens Wettability|Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.|Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
1388536|NCT01371552|Primary|Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear|"The participant circled a number from 1 to 5 in response to the question, Overall, which lens do you prefer - the lens you wore today or your regular lenses? in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Percentage of participants|||Number
1388537|NCT01371552|Primary|Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear|"The participant circled a number from 0 to 4 in response to the question, Over the entire day while wearing these contact lenses, how often did your eyes feel dry? in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 2|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Percentage of participants|||Number
1388538|NCT01371552|Primary|Mean Overall Ease of Handling at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall ease of handling these lenses? in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
1388539|NCT01371552|Primary|Mean Overall Quality of Vision at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall quality of vision while wearing these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
1388540|NCT01371552|Primary|Mean Overall Comfort Given at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall comfort of these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
1388541|NCT01371552|Primary|Mean Value of Comfort During the Day|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the comfort of your lenses over the last hour? in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged."|Part 1: Day 2 at 4 hours, 8 hours, and 12 hours|This reporting group includes all participants who completed 12 hours of lens wear on Day 2.|||Units on a scale||Standard Deviation|Mean
1388542|NCT01371539|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||logMAR||Standard Deviation|Mean
1388543|NCT01371539|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||logMAR||Standard Deviation|Mean
1388544|NCT01371110|Secondary|Percentage of Patients Who Meet Response and Remission|Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.|up to 14 days||||percentage of participants|||Number
1388545|NCT01371110|Primary|Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration|"The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine.~The 10 Y-BOCCS items are each scored on a four-point scale from 0 = no symptoms to 4 = extreme symptoms. The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme."|Baseline and 24 Hours||||Units on a scale||Full Range|Mean
1388546|NCT01371006|Secondary|Group B - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.~AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)|all subjects entered in sequence group B of the treated set.|||participants|||Number
1388547|NCT01371006|Secondary|Group A - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.~AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)|all subjects entered in sequence group A of the treated set.|||participants|||Number
1388548|NCT01371006|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From first treatment administration (Day 1) up to Day 24|treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication|||participants|||Number
1388549|NCT01371006|Secondary|Group B - Midazolam: AUC0-∞|Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1388909|NCT01368081|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Full analysis set|||percentage of HbA1c||Standard Error|Least Squares Mean
1388550|NCT01371006|Secondary|Group B - Midazolam: Tmax|Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.|||hours||Full Range|Median
1388551|NCT01371006|Secondary|Group B - Midazolam: Cmax|Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1388552|NCT01371006|Secondary|Group B - Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group B of the PK set|||hours||Full Range|Median
1388553|NCT01371006|Secondary|Group A - Efavirenz: Tmax|Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz|All patients entered in sequence group A of the PK set|||hours||Full Range|Median
1388554|NCT01371006|Secondary|Group A – Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1388555|NCT01371006|Secondary|Group A – Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1388556|NCT01371006|Secondary|Group A – Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence sequence group A of the PK set|||hours||Full Range|Median
1388557|NCT01371006|Secondary|Group A – Faldaprevir: Cmax,ss|Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1388558|NCT01371006|Primary|Group B - Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1388559|NCT01371006|Primary|Group B - Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1388560|NCT01371006|Primary|Group B - Faldaprevir: Cmax,ss|Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1388561|NCT01371006|Primary|Group A - Efavirenz: AUC0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz|all subjects entered in sequence group A of the PK set.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1388562|NCT01371006|Primary|Group A - Efavirenz: Cmax|Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz|all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1388563|NCT01370863|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks|The PAGI-SYM contains 20 items and the scores range from 0 (no symptoms)-5 (very severe symptoms) for each item with a total score of 0-100. Higher scores indicate more severe gastrointestinal symptoms.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.|||Units on a scale||Standard Deviation|Mean
1388564|NCT01370863|Secondary|Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks||Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.|||Number of days||Standard Deviation|Mean
1388565|NCT01370863|Primary|Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks|This is used to characterize gastric reflux events. The measurements were made over a 24-hour period at baseline and again at week 4.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.|||Number of Reflux Events||Standard Deviation|Mean
1388567|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).~This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects|||participants|||Number
1388568|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6.~This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (up to week 6)|Per Protocol Population|||participants|||Number
1388569|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used.~This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.|||participants|||Number
1388570|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).~This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects|||participants|||Number
1388571|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6.~This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population|||participants|||Number
1388572|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used.~This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)||||participants|||Number
1388613|NCT01370590|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388573|NCT01370733|Secondary|Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)|"All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change.~This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects|||units on a scale||Standard Deviation|Mean
1388574|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Per Protocol - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen.~For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population|||units on a scale||Standard Deviation|Mean
1388575|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Intent to Treat - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen.~For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.|||units on a scale||Standard Deviation|Mean
1388576|NCT01370694|Secondary|Clinical Response of Tumor to MK-8808/CVP Combination Therapy|The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.|Up to 2 years|All participants with evaluable data|||Participants|||Number
1388577|NCT01370694|Secondary|Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.||||||
1388578|NCT01370694|Secondary|Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.||||||
1388579|NCT01370694|Secondary|Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy|Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.||||||
1388580|NCT01370694|Secondary|Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP|Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.||||||
1388581|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of single agent MK-8808 up to 2 years|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.||||||
1388582|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of combination therapy up to 24 weeks|All participants receiving at least one dose of any study drug.|||Participants|||Number
1388583|NCT01370655|Secondary|Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28|Urine potassium (K+) levels were measured over 24-hours on Day -1 and on Day 28. The total amount of K+ excreted in the urine for Day-1 (baseline) and Day 28 were calculated and the difference between the 2 values was recorded.|Baseline (Day -1) and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmol/day||90% Confidence Interval|Least Squares Mean
1389612|NCT01361633|Secondary|Tower of London|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1388584|NCT01370655|Primary|Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.|Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Percentage of Participants|||Number
1388585|NCT01370655|Primary|Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.|up to 4 weeks of each treatment period|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Percentage of Participants|||Number
1388586|NCT01370655|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.|Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Percentage of Participants|||Number
1388587|NCT01370655|Primary|Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1|Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.|Baseline (Day-1) and Day 1|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmol/day||90% Confidence Interval|Least Squares Mean
1388588|NCT01370655|Primary|Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)|Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.|Baseline and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmHg||90% Confidence Interval|Least Squares Mean
1388589|NCT01370655|Primary|Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)|Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.|Baseline and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmHg||90% Confidence Interval|Least Squares Mean
1388590|NCT01370642|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.|||percentage of participants|||Number
1388591|NCT01370642|Secondary|Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||Log IU/ml||95% Confidence Interval|Least Squares Mean
1388614|NCT01370590|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388592|NCT01370642|Primary|Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted “Tier 1” safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.|||percentage of participants|||Number
1388593|NCT01370642|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.|At Week 24 or 48|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
1388594|NCT01370642|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
1388595|NCT01370642|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
1388596|NCT01370642|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.|12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
1388597|NCT01370642|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.|24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
1388598|NCT01370616|Secondary|Percentage of Participants Who Discontinued Treatment Due to an AE|Participants chose to discontinue treatment or were discontinued from the study by the investigator due to any untoward effects, or for safety reasons such as an AE. The investigator determined whether or not the AE caused the test drug to be discontinued.|Up to day 28|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
1388599|NCT01370616|Secondary|Percentage of Participants With Serious AEs (SAEs)|A SAE is an AE occurring at any dose that resulted in any of the following: death, was life threatening, a persistent or significant disability/incapacity, prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect in an offspring, was a cancer, an overdose, or other important medical events requiring medical or surgical intervention.|Up to day 42|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
1388600|NCT01370616|Secondary|Percentage of Participants With Drug-related AEs|A drug-related AE is any AE caused by the test drug as determined by an investigator who is a qualified physician. Drug-relatedness of the AE was assessed by evidence that the participant was actually exposed to the test drug, whether the AE followed a reasonable temporal sequence from administration of the test drug, and whether or not the AE was more reasonably explained by another source.|Up to day 42|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
1388601|NCT01370616|Secondary|Percentage of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the investigational product, whether or not considered related to the use of the medicinal product. This also includes any change in frequency and/or intensity of a preexisting condition which is temporally associated with the use of the medicinal product.|Up to day 42|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
1388602|NCT01370616|Secondary|Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for both a favorable clinical response (clinical improvement or cure) and a favorable microbiological response (eradication or presumptive eradication). Clinical improvement means that most pretherapy signs and symptoms of the index infection, had resolved, and no further IV antibiotic therapy is required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. Eradication means that the original pathogen was absent from the last available culture obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy and clinical assessment, appropriate antimicrobial therapy, and microbiological assessment. One participant from the Ertapenem arm with indeterminate clinical response, was excluded from the analysis. A modified LOCF (failure was carried forward), was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
1388932|NCT01367860|Secondary|VAS for Leg Pain - 6rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery|Intention to treat|||units on a scale||Standard Deviation|Mean
1388603|NCT01370616|Secondary|Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable microbiological response, defined as eradication or presumptive eradication. Eradication means that the original pathogen was absent from the last available culture of an adequate specimen obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy, adequate clinical assessment, appropriate antimicrobial therapy, and proper microbiological assessment. A modified LOCF, where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
1388604|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 15 up to Day 38|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at FUA, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
1388605|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at Day 5, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
1388606|NCT01370616|Primary|Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5 up to Day 28|Participants with confirmed clinical diagnosis, adequate IV study therapy, protocol-specified visit at DCIV, and no protocol-specific exclusions. A modified last-observation-carried-forward (LOCF), where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
1388607|NCT01370603|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388608|NCT01370603|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388609|NCT01370603|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388610|NCT01370603|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388611|NCT01370603|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|"Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have~substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period."|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388612|NCT01370603|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388615|NCT01370590|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388616|NCT01370590|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388617|NCT01370590|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388618|NCT01370590|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1388619|NCT01370564|Secondary|Estimate Changes in Clinical Markers of Heart Failure and Kidney Function|Changes in blood urea nitrogen from baseline to study exit (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|Subjects with blood urea nitrogen values at both the baseline and study exit visits|||mg/dL||Standard Deviation|Mean
1388620|NCT01370564|Secondary|Estimate Changes in Clinical Markers of Heart Failure and Kidney Function|Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|Subjects with lestimated glomular filtration rate values available at the baseline and study exit (3-month) visit.|||mL/min per 1.73 m^2||Standard Deviation|Mean
1388621|NCT01370564|Secondary|Summarize Adverse Events|All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.|Baseline through Completion/Exit (an average of 3-months)|All 21 subjects participating in the IPC study|||Participants|||Count of Participants
1388622|NCT01370564|Secondary|Estimate Changes in Clinical Markers of Heart Failure and Kidney Function|Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|Subjects with brain natriuretic peptide values at baseline and study completion (3-month visit) visits|||pg/dL||Standard Deviation|Mean
1388623|NCT01370564|Secondary|Quantify Subject Compliance to Daily PtIS|The proporition of IPC days study subjects indicated they complied with their PtIS.|Baseline through Completion/Exit (on average 3-months)|The analysis population is the total number of study participants. For each study subject, the number of days in which the subject indicated that they followed their PtIS|||proportion of compliant days||95% Confidence Interval|Number
1388624|NCT01370564|Secondary|Characterize the Rate of IPC Setup System Changes|The frequency of changes in the IPC setup during the study (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|The analysis population is the total number of study participants. For each study subject, the number of changes to the IPC setup were obtained|||changes per day||95% Confidence Interval|Number
1388625|NCT01370564|Primary|Characterize the Technical Feasibility of the Network Based IPC System|The proportion of study days a PtIS is based on the subjects' daily pressure state|Baseline through Completion/Exit (an average of 3 months)|The analysis population is the total number of study participants. For each study subject, the number of days in which the IPC system delivered a patient instruction set based on the subject's pressure state as measured by the Chronicle ICD/IHM pressure sensor.|||percentage of days|Days|95% Confidence Interval|Mean
1388626|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Per-protocol analysis set|||Percentage of heartburn free days||Standard Deviation|Mean
1388627|NCT01370538|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14|Full Analysis Set|||Participants|||Number
1388628|NCT01370538|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to day 14|Full Analysis Set|||Participants|||Number
1388629|NCT01370538|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Treatment period is considered to be both weeks 1 and 2 between V3 and V4.|From randomisation to the day 14|Full Analysis Set|||Participants|||Number
1388630|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set|||Percentage of heartburn free days||Standard Deviation|Mean
1388631|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomization to day 14|Per-protocol analysis set|||Percentage||Standard Deviation|Mean
1388632|NCT01370525|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14||||Participants|||Number
1388633|NCT01370525|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to the day 14|Full Analysis Set|||Participants|||Number
1388634|NCT01370525|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.|From randomisation to day 14|Full Analysis Set|||Participants|||Number
1388635|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set|||Percentage||Standard Deviation|Mean
1388636|NCT01370460|Secondary|Postoperative Transfusion Rate|Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.|participants will be followed for the duration of hospital stay, an expected average of 3 days||||participants|||Number
1388637|NCT01370460|Primary|Blood Loss|Preoperative and lowest postoperative hemoglobin|participants will be followed for the duration of hospital stay, an expected average of 3 days||||mL||Standard Deviation|Mean
1388638|NCT01370408|Secondary|Number of Patients That Experience Treatment Failure Within the First 24 Hours|Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours|24 hours||||participants|||Number
1388639|NCT01370408|Secondary|Number of Patients That Required First Administration of Rescue Medication Within 24 Hours|Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours|24 hours||||participants|||Number
1388640|NCT01370408|Secondary|Patients Who Experience First Emetic Episode Within 24 Hours|Number of patients with first emetic episode experienced within 24 hours|24 hours||||participants|||Number
1388641|NCT01370408|Secondary|Emetic Episodes|Number of emetic episodes|120 Hours||||episodes||Full Range|Mean
1388642|NCT01370408|Secondary|Complete Control Rate for Nausea & Vomiting|Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)|120 hours||||participants|||Number
1388643|NCT01370408|Secondary|Complete Remission During Overall Chemotherapy Time Period|Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period|120 hours||||participants|||Number
1388644|NCT01370408|Secondary|Complete Remission During Acute Phase Post-chemotherapy|Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)|24 hours||||participants|||Number
1388645|NCT01370408|Primary|Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting|Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.|120 hours||||participants|||Number
1388646|NCT01370369|Secondary|Frequency of Adverse Events (AEs)|The data were presented using descriptive statistics for this outcome.|From Baseline to Day 43|Safety Analysis Set population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||number of event|||Number
1388647|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.|||ng*hour/dL||Standard Deviation|Mean
1388648|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
1388649|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||ng/dL||Standard Deviation|Mean
1388650|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.|||pg*hour/mL||Standard Deviation|Mean
1388651|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
1388652|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||pg/mL||Standard Deviation|Mean
1388653|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.|||ng*hour/dL||Standard Deviation|Mean
1388654|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
1388655|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||ng/dL||Standard Deviation|Mean
1388656|NCT01370369|Secondary|Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 hr.|||ng*hour/dL||Standard Deviation|Mean
1388657|NCT01370369|Secondary|Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
1388658|NCT01370369|Secondary|Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||ng/dL||Standard Deviation|Mean
1388659|NCT01370369|Primary|Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.|Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.|From Baseline to Day 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||percentage of subjects|||Number
1388660|NCT01370356|Secondary|Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation|"The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant`s smoking status and other nicotine use was evaluated based on the last 4 weeks questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?; and Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
1388661|NCT01370356|Secondary|Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation|"The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant`s smoking status and other nicotine use was evaluated based on the last 7 days questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 7 days?; and Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 12, 24, and 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
1388662|NCT01370356|Secondary|Percentage of Participants With CO Confirmed Long Term CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Weeks 21 - 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
1388933|NCT01367860|Secondary|VAS for Leg Pain - 3rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery||||units on a scale||Standard Deviation|Mean
1388663|NCT01370356|Secondary|Percentage of Participants With CO Confirmed 4-Week CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 21 - 24|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
1388664|NCT01370356|Primary|Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking|Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 15 - 24|The Full Analysis Set was referred to as the Intent-to-Treat (ITT) population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
1388665|NCT01370265|Secondary|Hyperemic Blood Pressure (mmHg)|Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||mmHg||Standard Deviation|Mean
1388666|NCT01370265|Secondary|Heart Rate (Beats Per Minute (BPM))|The resting heart rate was measured approximately 35 minutes after arrival in the PET unit. The hyperemic heart rate was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||bpm||Standard Deviation|Mean
1388667|NCT01370265|Secondary|Segmental CFR|CFR was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||ratio||Standard Deviation|Mean
1388668|NCT01370265|Secondary|Hyperemic Segmental MBF|"Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes.~The hyperemic MBF was measured approximately 4 hours after arrival in the PET unit, depending on the randomization."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||mL/min/gm||Standard Deviation|Mean
1388669|NCT01370265|Secondary|Global Cardiac Flow Rate|Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||ratio||Standard Deviation|Mean
1388670|NCT01370265|Secondary|Resting Global MBF and Resting Segmental MBF|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Global Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).~Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes."|Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit|Resting MBF was measured on all subjects prior to the interventions.|||ml/min/gm||Standard Deviation|Mean
1388671|NCT01370265|Primary|Global Hyperemic Myocardial Blood Flow (MBF)|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).~The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||mL/min/gm||Standard Deviation|Mean
1388672|NCT01370083|Secondary|Tongue-palate Pressure Amplitude for Maximum Isometric Pressures|We will measure the amplitude of peak tongue-pressure amplitudes on maximum isometric pressure tasks performed using the Iowa Oral Performance Instrument. The maximum amplitude across a series of 3 maximum isometric pressure tasks performed with the bulb in a posterior position (flat end aligned with the first molar tooth) will be used to document tongue strength.|Post-treatment value|Individuals with complete pre and post-treatment data available|||Kilopascals||Standard Deviation|Mean
1388673|NCT01370083|Secondary|Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows|The Penetration-Aspiration Scale is an 8-point ordinal scale that addresses the depth of airway invasion and response to airway invasion during swallowing. We will measure penetration-aspiration for a series of 3 X 5 cc thin liquid swallows in videofluoroscopy. The participant's worst score will be taken to reflect their swallowing safety. This score will be collapsed into a binary score < vs. > 3 on the scale, reflecting material entering and remaining in or below the supraglottic space (versus transient entry or no entry at all).|Post-treatment (12 weeks)|Participants with complete pre and post-treatment videofluoroscopy data available.|||participants|||Number
1388688|NCT01370005|Secondary|Mean 24-hour Diastolic Blood Pressure Change From Baseline|Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388674|NCT01370083|Primary|Change in Swallow Response Time for 5 cc Thin Liquid Swallows|Swallow response time (the time duration between bolus passing the ramus of the shadow of the mandible and onset of hyolaryngeal excursion for airway protection 5cc thin liquid barium boluses in videofluoroscopy. Measures > 350 ms are considered to reflect impairment and a heightened risk of penetration-aspiration. The participant's mean swallow response time will be calculated across a series of 3 X 5 cc swallows and then reduced to a binary score < vs > 350 milliseconds.|Post treatment (12 weeks)||||participants|||Number
1388675|NCT01370005|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of participants with confirmed hypoglycaemic adverse events|From drug administration until last drug administration plus seven days, up to 171 days|Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.|||participants|||Number
1388676|NCT01370005|Secondary|Orthostatic Blood Pressure|Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.|Baseline and 12 weeks|Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.|||participants|||Number
1388677|NCT01370005|Secondary|Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight|A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure > 3 mmHg from baseline and reduction of weight from baseline > 2%|Baseline and 12 weeks|"Patients in the full analysis set (FAS). Treatment assignment as randomised.~Non-completers (missing data due to early discontinuation, values after start of rescue medication or changes in antihypertensive therapy) considered 'failure' was used as the imputation rule."|||participants|||Number
1388678|NCT01370005|Secondary|Proportion of Patients Reaching Blood Pressure <130/80 mmHg|Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment|Baseline and 12 weeks|"Patients in the FAS without blood pressure control at baseline. Blood pressure control is defined as DBP<80 mmHg and SBP <130 mmHg. Treatment assignment as randomised.~Non-completers (missing data due to early disc, values after start of rescue medication or changes in antihyp. therapy) considered 'failure' was used as the imputation rule."|||participants|||Number
1388679|NCT01370005|Secondary|Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in trough mean seated DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388680|NCT01370005|Secondary|Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388681|NCT01370005|Secondary|Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in nighttime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388682|NCT01370005|Secondary|Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in nighttime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388683|NCT01370005|Secondary|Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in daytime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388684|NCT01370005|Secondary|Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in daytime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388685|NCT01370005|Secondary|Body Weight Change From Baseline|Change from baseline in body weight after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."|||kg||Standard Deviation|Mean
1388686|NCT01370005|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|Change from baseline in FPG after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."|||mg/dL||Standard Deviation|Mean
1388687|NCT01370005|Secondary|Proportion of Patients With HbA1c <7%|Proportion of patients with HbA1c <7% after 12 weeks.|Baseline and 12 weeks|"Patients in the full analysis set (FAS) and with baseline HbA1c >= 7%. Treatment assignment as randomised.~Non-completers (missing data due to early discontinuation or values after start of rescue medication) considered 'failure' was used as the imputation rule."|||participants|||Number
1388689|NCT01370005|Primary|Mean 24-hour Systolic Blood Pressure Change From Baseline|Change from baseline of mean 24-hour systolic blood pressure (SBP).|Baseline and 12 weeks|"FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
1388690|NCT01370005|Primary|HbA1c Change From Baseline|Change from baseline in HbA1c after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||percentage of HbA1c||Standard Deviation|Mean
1388691|NCT01369888|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months, 9 days||||participants|||Number
1388692|NCT01369888|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL.|Intravenous recombinant IL-15 as a daily intravenous bolus for 10 consecutive days in patients with metastatic melanoma who have received a lymphodepleting chemotherapy and ACT TIL with dose escalation (i.e., dose level 1: 0.25 mcg, dose level 2: 0.50 mcg, dose level 3: 1 mcg, and dose level 4: 2 mcg) to further characterize the safety of the MTD prior to starting the phase 2 portion.|2 years||||mcg/kg/day|||Number
1388693|NCT01369875|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 years||||Participants|||Number
1388694|NCT01369875|Primary|Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|3 years||||Participants|||Number
1388695|NCT01369849|Secondary|Treatment-free Survival|Treatment free survival is defined to be the time from registration to the date of initation of subsequent therapy or death. The distribution of treatment free survival will be estimated using the method of Kaplan-Meier.|Time from registration to the date of initiation of subsequent therapy or death, median follow-up time is 37 months|All patients that were treated and evaluable were included in this endpoint.|||months||95% Confidence Interval|Median
1388696|NCT01369849|Secondary|Overall Response Rate|The Overall response rate is estimated by the total number of complete or partial responses (CR, CRi, CCR, nPR, or PR) divided by the total number of evaluate patients. Complete and partial responses were scored using the NCI Working Group criteria. A Complete Response (CR, CRi, and CCR) is characterized by an absence of lymphadenopathy, heptomegaly and splenomegaly with or without normalized blood counts and bone marrow assessment . A PR is defined as having >50% decrease in lymphocyte count and reduction in sum of the products of measured nodes and an improvement in blood counts. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.|3 months post-treatment|All patients that were treated and evaluable for response were included together in this endpoint.|||proportion of patients||95% Confidence Interval|Number
1388697|NCT01369849|Secondary|Minimal-residual Disease|Minimal residual disease (MRD) will be evaluated after treatment in patients who achieve a complete clinical response. Flow cytometry will be used to detect approximately 1 CLL cell per 10,000 leukocytes following induction. A score of positive means CLL cells were found and a negative score means no CLL cells were found. The number of patients with an MRD negative score are reported here.|Cycle 6 assessment (maximum of 231 days post-registration)|5 patients achieved a complete response and were analyzed for MRD|||Participants|||Count of Participants
1388698|NCT01369849|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient’s objective status is first noted to be a CR, CRi, CCR, nPR, or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Median follow-up of 39 months and maximum follow-up of 54 months|12 patients achieved a response and were included in this analysis.|||months||95% Confidence Interval|Median
1388699|NCT01369849|Secondary|Fluorescent in Situ Hybridization (FISH) Biomarker Analysis|Fluorescent in situ hybridization (FISH) is a molecular cytogenetic technique that uses fluorescent probes that bind to only those parts of the chromosome with a high degree of sequence complementarity. It was developed by biomedical researchers in the early 1980s and is used to detect and localize the presence or absence of specific DNA sequences on chromosomes. In this disease group, there are recognized patterns of DNA sequences that play a role in prognostic outcomes. Patterns named 11q-, 13q-, Trisomy 12 may lead to different responses to treatments. Here we report the number of patients with each FISH prognosis evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.|||Participants|||Count of Participants
1388700|NCT01369849|Secondary|Biomarker Analysis (CD38, CD49d, and ZAP-70)|CD38, CD49d, and ZAP-70 status will be evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.|||Participants|||Count of Participants
1388714|NCT01369784|Secondary|Ann Arbor Staging|Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition|At the beginning of the 2nd line of treatment||||percentage of patients|||Number
1388701|NCT01369849|Secondary|Biomarker Analysis (IgVH Gene Mutation)|IgVH gene mutationwill be evaluated pre-treatment. This factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.|||Participants|||Count of Participants
1388702|NCT01369849|Primary|Proportion of Complete Response Defined to be a CR or CRi Noted as the Objective Status (Phase II)|"A Complete Response (CR) is defined by the NCI Working Group criteria and requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy (e.g. lymph nodes >1.5 cm) by physical examination.~No hepatomegaly or splenomegaly by physical examination.~Absence of constitutional symptoms.~Neutrophils ≥1500/ul.~Platelets >100,000/ul (untransfused).~Hemoglobin >11.0 gm/dl (untransfused)~Peripheral blood lymphocytes <4000/uL~Patients who fulfill all criteria for a CR but who have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity rather than residual CLL will be classified as CR with incomplete marrow recovery (CRi).~The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|From registration to response, up to 84 days|All eligible patients treated at Dose Level 1 were included in the Phase II primary endpoint. All 6 patients from Phase I, Dose level 1 and 4 of the 5 patients registered to the Phase II portion of the study were eligible for this endpoint.|||percentage of participants||95% Confidence Interval|Number
1388703|NCT01369849|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.The number of patients reporting a dose-limiting event are reported.|Up to 35 days|Only the patients registered to the Phase I portion of this study were analyzed for this endpoint. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 are included in this endpoint.|||Patients reporting Dose-Limiting Events|||Number
1388704|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse||||mg/100ml||Standard Deviation|Mean
1388705|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse||||participants|||Number
1388706|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse||||participants|||Number
1388707|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
1388708|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
1388709|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
1388710|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
1388711|NCT01369784|Primary|Predictive Value of R-IPI at Diagnosis||At diagnosis||||participants|||Number
1388712|NCT01369784|Secondary|Response to Second Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.~Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After second line of treatment||||participants|||Number
1388713|NCT01369784|Secondary|Response to First Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.~Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After first line treatment||||participants|||Number
1388720|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|The IPI is based on the evaluation of 5 clinical factors: age > 60 years Ann Arbor stage III or IV disease > 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.|At the beginning of the 2nd line of treatment, an average of 2 years||||percentage of patients|||Number
1388721|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At the beginning of the second line of treatment||||percentage of participants|||Number
1388722|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At diagnosis||||participants|||Number
1388723|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At the beginning of the 2nd line of treatment||||participants|||Number
1388724|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At diagnosis||||percentage of participants|||Number
1388725|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|Data will be recorded from diagnosis to second line response, an expected average of 7 months|At diagnoses||||percentage of participants|||Number
1388726|NCT01369758|Secondary|Percentage of Subjects That Achieve 100% Removal of Target Pathology|Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.|1 hour post treatment||||percentage of participants||95% Confidence Interval|Number
1388727|NCT01369758|Primary|Procedure Efficacy|Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure|1 hour post treatment|559 pathologies, 187 Fibroids and 372 polyps, were removed from 278 patients.|||percent of pathology||95% Confidence Interval|Mean
1388728|NCT01369745|Secondary|Time to Failure (Days)|Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.|Baseline to 12 weeks|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
1388729|NCT01369745|Secondary|Multidimensional Assessment of Fatigue (MAF) at Week 12|"The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week.~To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15.~Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they do not do any activity for reasons other than fatigue. If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index."|week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
1388730|NCT01369745|Secondary|Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks|The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.|Week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
1388731|NCT01369745|Secondary|Change From Baseline in DAS28-CRP Individual Components at 12 Weeks|"The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity."|Baseline to week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
1388732|NCT01369745|Primary|Change From Baseline in DAS28-CRP at 12 Weeks|"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores."|baseline to week 12|The efficacy analysis population includes all 252 subjects who received at least one dose of study drug after randomization and who provided at least one post-baseline measurement of the primary endpoint|||units on a scale||Standard Deviation|Mean
1388740|NCT01369680|Secondary|Pain Control|"Subjects will be assessed for clinically significant change in pain scores during and after study drug administration. Significant change in pain scores were determined at week 2, though week 14 scores were collected as well.~Participants with a 2 point (or greater) decrease in pain scores compared to baseline were considered to have responded. The NRS scale was used, the scale ranges from 0-10, with 10 being the most pain."|Week 2|Number of participants for analysis was determined in negotiation with the FDA for safety of all participants.|||participants|||Number
1388741|NCT01369680|Secondary|Norketamine Cmax (Measured in ng/mL).|Pharmacokinetic testing will be done during chronic ketamine administration on subjects consenting to additional testing one week into study drug administration. This is to further describe the activity of ketamine in the blood of children when administered chronically and to enable comparison of any clinical effect or toxicity with steady state levels of ketamine in children.|At week 1|All participants consenting for pharmacokinetics were analyzed. No participants in ketamine 1.5 mg/kg/dose group consented for pharmacokinetics.|||ng/mL||Full Range|Mean
1388742|NCT01369680|Secondary|Neurocognitive Effect|"Baseline neurocognitive testing will be done before study drug is given. Subjects will be reassessed for any changes in neurocognitive scores at end of dosing (week 2) and at three weeks off study drug (week 14). Significant changes were measured at week 14 compared to baseline. Week 2 was measured to inform future studies.~The neurocognitive scores are standardized scores with a mean of 100; low scores correlate with low neurocognitive function, while high scores correlate with high function. A significant change is defined as greater than or equal to 10% decrease in scores."|At 14 weeks|All participants not lost to follow-up were analyzed|||participants|||Number
1388743|NCT01369680|Primary|Number of Participants Tolerating Dose|According to CTCae any dose causing grade 2 or worse toxicity will be an untolerated dose. Tolerability is defined as ability to take the medication for 2 weeks without having a grade 2 or worse toxicity.|Up to 2 weeks|Number of participants was determined through negotiation with the FDA for safety of all participants.|||participants|||Number
1388744|NCT01369641|Primary|Efficacy of Intratympanic Sodium Thiosulfate (STS)|"To assess the efficacy of intratympanic sodium thiosulfate (STS) on reducing the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy using puretone and speech audiometry, and distortion product otoacoustic emissions (DPOAE).~Pure tone and speech audiometry: hearing will be assessed prior to any initiation of cisplatin therapy, again at three weeks, 6 weeks, 12 weeks, and every 6 months thereafter for up to one year."|Through 1 year post-treatment|||||||
1388745|NCT01369615|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.|Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).|The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.|||participants|||Number
1388746|NCT01369511|Secondary|Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16|The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by DEXA. LS means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via an MMRM analysis.|Baseline, 4 Weeks, 8 Weeks, and 16 Weeks|Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.|||percentage change in aLBM (3 limbs)||Standard Error|Least Squares Mean
1388747|NCT01369511|Primary|Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12|The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis.|Baseline, 12 Weeks|Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.|||percentage change in aLBM (3 limbs)||Standard Error|Least Squares Mean
1388748|NCT01369485|Primary|Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week and 12 month median change from baseline in mean urgency (urinary) incontinence episodes (leaks) between treatment groups. The mean of the number of urinary incontinence episodes over 24 hours” is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).~Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov – Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks (Randomized Phase) and 12 Months (Open Label)||||Episodes/day||Inter-Quartile Range|Median
1388749|NCT01369485|Secondary|Change Clinical Global Impressions at 12 Weeks|"CGI is an Investigator assessment, which rates the severity of illness at baseline on a scale of 1 (normal, not ill at all) to 7 (Amongst the most extremely ill patients), and then rates improvement at 12 weeks on a scale of 1 (very much improved) to 10 (very much worse). The analysis was based upon the number of patients that much and very much improved."|12 weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to treat|||% patients much or very much improved|||Number
1388750|NCT01369485|Secondary|Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)|Overall satisfaction with treatment was assessed (OAB-SAT-q) an 11 question list with multiple scaled checkboxes to allow the subject to rate the treatment with regard to satisfaction, bother from side effects, treatment endorsement, and convenience.|12 weeks|Intent to treat population for those who had prior treatment for OAB.|||percentage of patient prefer treatment|||Number
1388934|NCT01367860|Secondary|VAS for Leg Pain - 1st Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery||||units on a scale||Standard Deviation|Mean
1388751|NCT01369485|Secondary|Assessment of Treatment Benefit Scale (TBS)|TBS is a patient-reported outcome comprised of a 4-point scale of checkboxes to describe the change in condition during treatment (greatly improved to worsened). Improvement was defined as a change in the patient's assessment of overall condition to improved or greatly improved over the course of treatment. Analysis was based upon the number of patients who reported an improvement in condition.|12 Weeks|Intent to Treat|||percentage patients improved (responded)|||Number
1388752|NCT01369485|Secondary|Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.|PPBC is a 6-point scale (from 'no problems at all' to ‘many severe problems’) describing the problem level of the bladder condition at that moment. Improvement is defined as a reduction in the number and/or severity of observed problems.|12 Weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to Treat|||percentage of patients that improved|||Number
1388753|NCT01369485|Secondary|Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12|The OAB-q is validated to measure symptom bother and life impact due to OAB. It consists of an 8-item Bother Scale to assess individual symptoms and a 25-item HRQL scale that in turn consists of 4 subscales (coping-8 items, concern-7 items, sleep-5 items and social-5 items) to assess impact on life. Responses for each item in the Bother Scale range from 1 (bothered not at all by the symptom) to 6 (Bothered A Very Great Deal). Scores are then added generating an overall Bother Score (severity) ranging from 8 to 48. For HRQL, individual responses range between 1-None of the Time to a 6-All of the Time. Subscale scores range from 8-48 (coping) 7-42 (concern), 5-30 (sleep) and 5-30 (social). Subscale scores are then added to generate the HRQL ranging between 25-150. Raw HRQL scores are transformed for standardization purposes as follows: ((Highest Possible Score-Actual Raw Score)/Range of Scores)*1 00 so that scores could range from 0 (All of the Time) to 100 (None of the Time).|12 Weeks (Randomized Phase) and 12 Months (Open Label).|Intent to Treat|||units on a scale||Inter-Quartile Range|Median
1388754|NCT01369485|Secondary|Measure Improvement in the Median of the Mean OAB-Symptom Composite Score|"OAB Symptom Composite Score (OAB-SCS) is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence combining the Indevus Urgency Severity Scale (IUSS) for capture of urgency severity per toilet void with 24-hour frequency and UUI episodes.~IUSS Score/void and/or UUI is assigned an OAB-SCS Point/Void: 0(none)=1, 1(mild/easily tolerated)=2, 2(moderate discomfort interfering with activities)=3, 3(severe/extreme urgency discomfort that abruptly stopped all activity or tasks)=4, UUI without void=5.~Overall OAB-SCS Score is calculated for each day by multiplying the OAB-SCS Points/Void and/or UUIs by the number of events meeting criteria and adding the individual scores together. The minimum overall OAB-SCS score in a 24 hour period would be a 1 (representing a single mild void with a OAB –SCS Point/Void score of 0). The score would increase based upon the number voids/events and overall severity each event. Medians calculated for each treatment group."|12 weeks||||units on a scale||Inter-Quartile Range|Median
1388755|NCT01369485|Secondary|Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes|"Evaluate the 12 week change from baseline in median for mean number of urgency episodes between the active and sham treatment groups.~Patients were required to complete seven 3-day voiding diaries throughout the course of the study. The voiding diary collected the following information: amount voided (in ml); urgency associated with each toileted void , approximate time of leak, and presence of urge preceding leak.The mean number of urgency episodes over 24 hours was then calculated for each patient during the observation period. The change in median for the mean of the number of urgency episodes over 24 hours) for each treatment group was then calculated.~Distribution of changes from baseline were assessed prospectively using the Kolmogorov – Smirnoff test. The Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks||||Difference in episodes/24 Hours||Inter-Quartile Range|Median
1388756|NCT01369485|Secondary|Measure Median Change in Mean Volume Per Void|Evaluate the 12 week median change from baseline in mean volume (ml) per void between the active and sham treatment groups|12 weeks||||ml||Inter-Quartile Range|Median
1388757|NCT01369485|Secondary|Measure Change in the Median of the Mean Urinary Frequency|"Evaluate the 12 week change from baseline in median urinary frequency between the active and sham treatment groups.~Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov – Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks and 12 Months||||Episodes/24 hours||Inter-Quartile Range|Median
1388758|NCT01369485|Primary|Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours” is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).~The primary objective of the open label phase of the study is to evaluate and confirm the continued efficacy of the VERV™ System for long-term use. The primary objective was assessed with rate of responders, where responder was defined as a subject who achieved a decrease of ≥50% in mean urgency urinary incontinence episodes at 12 weeks compared to baseline."|12 weeks (Randomized Phase) and 12 Months (Open Label)|Intent to treat population. Responders are defined as patients who had a greater than or equal to 50% decrease in mean number urgency incontinence episodes over 24 hours.|||Number of responders|||Number
1388759|NCT01369355|Secondary|Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy|Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
1388760|NCT01369355|Secondary|Number of Participants With Corticosteroid-free Remission at Week 44|Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
1388761|NCT01369355|Secondary|Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study|Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to Ustekinumab at week 0 of maintenance study.|Week 44|Analysis population included all randomized participants after the study was restarted (who were in clinical remission at Week 0 of maintenance study). 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1388762|NCT01369355|Secondary|Number of Participants With Clinical Response at Week 44|Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
1388763|NCT01369355|Primary|Number of Participants With Clinical Remission at Week 44|Clinical remission at Week 44 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn’s disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
1388764|NCT01369342|Secondary|Number of Participants With CDAI 70 Point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388765|NCT01369342|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388766|NCT01369342|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388767|NCT01369342|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission at Week 8 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388768|NCT01369342|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388769|NCT01369329|Secondary|Number of Participants With CDAI 70-point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388770|NCT01369329|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388771|NCT01369329|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388773|NCT01369329|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
1388774|NCT01369225|Other Pre-specified|Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52|The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
1388775|NCT01369225|Other Pre-specified|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52|The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
1388776|NCT01369225|Other Pre-specified|Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52|The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
1388777|NCT01369225|Other Pre-specified|Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52|The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
1388778|NCT01369225|Other Pre-specified|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52|ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
1388779|NCT01369225|Other Pre-specified|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer|Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer >=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported.|Baseline, Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions); n=number of evaluable participants at the specified time point.|||participants|||Number
1388780|NCT01369225|Primary|Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings|Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388781|NCT01369225|Primary|Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388782|NCT01369225|Primary|Number of Participants With Abnormal Neurological Examination Findings|Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388935|NCT01367860|Secondary|VAS for Leg Pain - 1st Week|Pain Score for leg pain- Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery||||units on a scale||Standard Deviation|Mean
1388783|NCT01369225|Primary|Number of Participants With Abnormal Physical Examination Findings|A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388784|NCT01369225|Primary|Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=200 msec or >=50% increase from baseline when baseline is less than or equal to 100 msec and >=25% increase when baseline is >100 msec; and QTcF >=450 msec or >=30 msec increase.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388785|NCT01369225|Primary|Number of Participants With Potentially Clinically Important Vital Sign Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm); standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388786|NCT01369225|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388787|NCT01369225|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
1388788|NCT01369199|Secondary|Absence of Detectable Antiviral Drug-resistance HBV Mutations||End of treatment (up to 48 weeks)||2018-09-30|09/2018||||
1388789|NCT01369199|Secondary|Proportion of Participants With HBV DNA <20 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388790|NCT01369199|Secondary|Proportion of Participants With HBV DNA <20 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388791|NCT01369199|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388792|NCT01369199|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388793|NCT01369199|Secondary|Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388794|NCT01369199|Secondary|Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388795|NCT01369199|Secondary|Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388796|NCT01369199|Secondary|Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388797|NCT01369199|Secondary|Proportion of Participants With HBsAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388798|NCT01369199|Secondary|Proportion of Participants With HBsAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388799|NCT01369199|Secondary|Proportion of Participants With HBsAg Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388800|NCT01369199|Secondary|Proportion of Participants With HBsAg Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388801|NCT01369199|Secondary|Proportion of Participants With HBeAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388802|NCT01369199|Secondary|Proportion of Participants With HBeAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388803|NCT01369199|Secondary|Proportion of Participants With HBeAg Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388804|NCT01369199|Secondary|Proportion of Participants With HBeAg Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388805|NCT01369199|Primary|Incidence of Serious Adverse Events (SAEs) Per Person-Year|The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||SAEs per person-year of observation||95% Confidence Interval|Number
1388806|NCT01369199|Primary|Incidence of Adverse Events (AEs) Per Person-Year of Observation|The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||Events per person-year of observation||95% Confidence Interval|Number
1388807|NCT01369199|Primary|Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL|Lack of data was considered to be treatment failure.|End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388808|NCT01369108|Primary|Clinical Performance by VAS (Pain Scale)|"Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ‘‘X’’ on a 10-mm line labeled ‘‘1’’ on the left and ‘‘10’’ on the right. Patients were told that a ‘‘10’’ represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that~‘‘1’’ represents no sensation at all."|baseline, 6, 12 and 24 months||||units on a scale|teeth|Standard Deviation|Mean
1388809|NCT01369108|Primary|Clinical Performance by Cvar & Ryge Scores|"Clinical performance reported on 6 parameters as the % of teeth with perfect scores (A rating).~Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present)."|baseline, 6, 12 and 24 months||||percent of teeth|teeth||Number
1388810|NCT01369030|Secondary|Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale|"Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating not at all satisfied and 9 as very satisfied."|Baseline to Endpoint (90 days)||||units on a scale||Full Range|Mean
1388811|NCT01369030|Secondary|Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms||Baseline to Endpoint (90 days)||||percentage of participants|||Number
1388812|NCT01369030|Primary|Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value 0 represents not at all, 1 several days, 2 indicates more than half the days, and the maximum value 3 stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression."|Baseline to Endpoint (90 days)|Analyses were performed on the 554 patients who had a baseline PHQ-9>=5 and further analyzed by baseline depression severity groups defined by baseline PHQ-9 scores: 5<=PHQ-9<=9; 10<=PHQ-9<=14; 15<=PHQ-9<=19; and 20<=PHQ-9<=27.|||units on a scale||Standard Deviation|Mean
1388813|NCT01368965|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera treatment||||Average NRS score||Full Range|Mean
1388814|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.|||percentage of participants Satisfied|||Number
1388815|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90 Days post-treatment|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.|||percentage of participants Satisfied|||Number
1388816|NCT01368965|Secondary|Global Aesthetic Improvement at 180 Days Post-treatment|At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|180 days post-treatment|"Subjects completing the 180-Day SGAIS = 39; however, the 180-Day PGAIS was not obtained for 2 subjects. PGAIS data are based on n=37.~The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"|||percentage of participants improved|||Number
1388955|NCT01367834|Secondary|Volume of Brain Lobes (Occipital)|Percent change in volumes of occipital lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388817|NCT01368965|Secondary|Global Aesthetic Improvement at 90 Days Post-treatment|At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|90 Days post-treatment|"The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"|||percentage of participants improved|||Number
1388818|NCT01368965|Primary|Change in Overall Lifting and Tightening of Treated Tissue|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos|90 days post treatment|Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site.||||||
1388819|NCT01368900|Other Pre-specified|Subject Assessment of Pain|Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.|Average pain scores reported during study treatment|The subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated, using a validated numeric rating scale of 0-10 with 1 representing no pain and 10 representing the highest degree of pain.|||units on a scale||Full Range|Mean
1388820|NCT01368900|Secondary|Patient Satisfaction Questionnaire at 180 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.|180 days post-treatment|Data analyzed included subjects completing a 180 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 180 post-treatment photographic images. Responses were tabulated. 60 of 61 subjects provided responses. One subject's response was missing.|||percentage of participants Satisfied|||Number
1388821|NCT01368900|Secondary|Patient Satisfaction Questionnaire 90 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.|90 days post-treatment|Data analyzed included subjects completing a 90 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 90 post-treatment photographic images. Responses were tabulated.|||percentage of participants Satisfied|||Number
1388822|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 180 days post-treatment, per protocol.|||percentage of participants improved|||Number
1388823|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 90 days post-treatment, per protocol.|||percentage of participants improved|||Number
1388824|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment|"At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|60 days post-treatment|At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
1388825|NCT01368900|Primary|Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes|Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.|90 days post-treatment|Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.|||percentage of participants improved|||Number
1388826|NCT01368874|Secondary|L'Oreal Photographic Scale 180 Days Post-treatment|"At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|180 Days post-treatment||||units on a scale||Full Range|Mean
1388827|NCT01368874|Secondary|L'Oreal Photographic Scale 90 Days Post-treatment|"At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|90 Days post-treatment||||units on a scale||Full Range|Mean
1388828|NCT01368874|Secondary|L'Oreal Photographic Scale Baseline|"At baseline, the Principal Investigator (PI) assessed the subjects’ horizontal neck folds, neck sagging, and texture and ptosis changes using the L’Oreal Photographic Scales. The L’Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|Baseline||||units on a scale||Full Range|Mean
1388829|NCT01368874|Secondary|Patient Satisfaction Questionnaire 180 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|180 days post-treatment||||Percentage of participants|||Number
1388830|NCT01368874|Secondary|Patient Satisfaction 90 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|90 Days post-treatment||||Percentage of participants|||Number
1388831|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|180 days post-treatment|At 180 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
1388832|NCT01368874|Other Pre-specified|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible.|During Ulthera treatment||||units on a scale||Full Range|Mean
1388833|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP|"Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.~A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results."|90 Days post-treatment||||participants|||Number
1388834|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|90 days post-treatment|At 90 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
1388835|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|60 days post-treatment|At 60 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
1388836|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity|Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.|90 Days post-treatment||||participants|||Number
1388837|NCT01368835|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera study treatment|Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed.|||Average NRS score||Full Range|Mean
1388838|NCT01368835|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available.|||percentage of participants improved|||Number
1388839|NCT01368835|Secondary|Change in Submental and Neck Skin Laxity by Quantitative Analysis|The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants.|||percentage of participants improved|||Number
1388840|NCT01368835|Primary|Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants, for a masked assessment.|||percentage of participants improved|||Number
1388841|NCT01368809|Secondary|Postoperative Pain|"Postoperative pain measured using a Verbal Rating Scale (VRS) at post-anesthesia care unit (PACU), (90 minutes after arriving).~Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain."|one day||||Scores on a scale||Standard Deviation|Mean
1388842|NCT01368809|Secondary|Incidence of Nausea and Vomiting|Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.|1 day||||participants|||Number
1388843|NCT01368809|Primary|Incidence of Coughing|during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.|one day||||participants|||Number
1388844|NCT01368653|Secondary|Prolonged Abstinence|This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.|10 weeks||||participants|||Number
1388845|NCT01368653|Secondary|Mediators of Treatment Effects|Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators of the first phase treatment. Additional analyses of reports of emotions, thoughts, and behaviors will explore mediators of non-nicotine cigarette effects on smoking. These measures will be analyzed to see if treatment affects them and if they predict smoking behavior.|1 week post-quit and 6 weeks post-quit|||||||
1388846|NCT01368653|Secondary|10-week Abstinence|This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.|10 weeks||||participants|||Number
1388847|NCT01368653|Primary|4-week Abstinence|7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).|4 weeks||||participants|||Number
1388848|NCT01368536|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone||12 weeks|Safety Set — Consists of all patients who received at least one dose of the double-blind study drug. Patients were analyzed according to the treatment that they received.|||Participants|||Number
1388849|NCT01368536|Secondary|Percentage of Patients Achieving Blood Pressure Control After Treatment|Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg.|12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1388850|NCT01368536|Secondary|Percentage of Responders After Treatment|Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1388851|NCT01368536|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment|Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1388852|NCT01368536|Secondary|Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1388853|NCT01368536|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1388875|NCT01368497|Primary|Incidence of Serious Adverse Events (SAEs) Per Person-Year|The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||SAEs per person-year of observation||95% Confidence Interval|Number
1389613|NCT01361633|Secondary|Wisconsin Card Sort Test|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1388854|NCT01368497|Secondary|Tanner Stages of Pubic Hair Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth.~Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of follow-up (up to 96 weeks)||||Participants|||Count of Participants
1388855|NCT01368497|Secondary|Tanner Stages of Pubic Hair Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth.~Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of treatment (up to 48 weeks)||||Participants|||Count of Participants
1388856|NCT01368497|Secondary|Tanner Stages of Physical Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth.~Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia.~Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of follow-up (up to 96 weeks)||||Participants|||Count of Participants
1388857|NCT01368497|Secondary|Tanner Stages of Physical Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth.~Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia.~Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of treatment (up to 48 weeks)||||Participants|||Count of Participants
1388858|NCT01368497|Secondary|Growth Measures: Z-scores Weight, Height, and Body Mass Index|A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.|End of follow-up (up to 96 weeks)||||Z-score||95% Confidence Interval|Mean
1388859|NCT01368497|Secondary|Growth Measures: Z-scores Weight, Height, and Body Mass Index|A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.|End of treatment (up to 48 weeks)||||Z-score||95% Confidence Interval|Mean
1388860|NCT01368497|Secondary|Absence of Detectable Antiviral Drug-resistance HBV Mutations||End of treatment (up to 48 weeks)||2018-09-30|09/2018||||
1388861|NCT01368497|Secondary|Proportion of Participants With HBV DNA < 20 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388862|NCT01368497|Secondary|Proportion of Participants With HBV DNA < 20 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388863|NCT01368497|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388864|NCT01368497|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388865|NCT01368497|Secondary|Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388866|NCT01368497|Secondary|Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388867|NCT01368497|Secondary|Proportion of Participants With HBsAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388868|NCT01368497|Secondary|Proportion of Participants With HBsAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388869|NCT01368497|Secondary|Proportion of Participants With HBeAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388870|NCT01368497|Secondary|Proportion of Participants With HBeAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388871|NCT01368497|Secondary|Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388872|NCT01368497|Secondary|Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388876|NCT01368497|Primary|Incidence of Adverse Events (AEs) Per Person-Year|The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||AEs per person-year of observation||95% Confidence Interval|Number
1388877|NCT01368497|Primary|Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL)||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
1388878|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At 12 weeks||||units on a scale||Standard Deviation|Mean
1388879|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At baseline||||units on a scale||Standard Deviation|Mean
1388880|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)."|At 12 weeks||||units on a scale||Standard Deviation|Mean
1388881|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)."|At baseline||||units on a scale||Standard Deviation|Mean
1388882|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At 12 weeks||||units on a scale||Standard Deviation|Mean
1388883|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At baseline||||units on a scale||Standard Deviation|Mean
1388884|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable."|12 weeks||||units on a scale||Standard Deviation|Mean
1388885|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable."|baseline||||units on a scale||Standard Deviation|Mean
1388886|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|12 weeks||||units on a scale||Standard Deviation|Mean
1388887|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|Baseline||||units on a scale||Standard Deviation|Mean
1388888|NCT01368432|Secondary|Clinical Global Impression (CGI)- Improvement|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.~The scores range from 1-7~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse"|at 12 weeks||||units on a scale||Standard Deviation|Mean
1388889|NCT01368432|Secondary|Clinical Global Impression (CGI) - Severity at Baseline|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7~= Normal—not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients."|Baseline||||units on a scale||Standard Deviation|Mean
1388890|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.~In this study the score was used as a continuous variable."|MADRS score at 12 weeks||||units on a scale||Standard Deviation|Mean
1388891|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 – normal; 7 to 19 – mild depression; 20 to 34 – moderate depression; >34 – severe depression.~In this study the score was used as a continuous variable."|MADRS score at baseline||||units on a scale||Standard Deviation|Mean
1388892|NCT01368406|Primary|Change in Weight From Baseline to Endpoint|All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes.Measures were collected by the same investigator in all assessments.|baseline, 3-month||||kg||95% Confidence Interval|Mean
1388906|NCT01368185|Primary|Serum Uric Acid (SUA) Level|SUA at baseline and Month 3.|Baseline and Month 3||||mg/dL||Standard Deviation|Mean
1388907|NCT01368081|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients|||participants|||Number
1389614|NCT01361633|Secondary|Logical Memory Subtests|Measures verbal memory recall|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1388893|NCT01368276|Secondary|Durable Response Rate|"Durable response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) assessed by the investigator, initiating at any time while receiving talimogene laherparepvec or GM-CSF therapy on the 005/05 or the 005/05-E study and maintained continuously for at least 6 months from response initiation. This reflects all new sites of disease as well as disease sites identified at baseline.~Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1388894|NCT01368276|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. Best overall response for a patient is the best overall response observed across all time points and is cumulative (ie, includes responses during the parent study 005/05 and during Study 005/05-E).~Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|The full analysis set for the extension study is defined as all participants who received at least one dose of extension treatment.|||percentage of participants||95% Confidence Interval|Number
1388895|NCT01368276|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|"AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline:~Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.~Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator.~A serious AE is one that meets one or more of the following criteria/outcomes:~Results in death.~Is life-threatening.~Requires inpatient hospitalization or prolongation of existing hospitalization.~Results in persistent or significant disability/incapacity.~Is a congenital anomaly/birth defect.~Is an important medical event."|From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.|Safety population (randomized participants who received at least one dose of extension treatment).|||participants|||Number
1388896|NCT01368263|Secondary|PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less||16 weeks|(1) of the participants in Group 1 had an inconclusive PEPI score at week 16 and was not evaluable. (1) of the participants in Group 1 did not have surgery and was not evaluable. Participants in Group 2 and Group 3 were not evaluable for this outcome as the estradiol and Ki67 levels were above outcome specified levels.|||percentage of participants|||Number
1388897|NCT01368263|Secondary|Preoperative Endocrine Prognostic Index Score (PEPI Score)|To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).|At time of definitive surgery|2 participants in Group 1 did not have a PEPI score at time of surgery as (1) participant did not have nodal dissection and (1) did not have surgery. Both participants in Group 2 and Group 3 did not have surgery study tissue collected|||participants|||Number
1388898|NCT01368263|Secondary|Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67||Baseline and 4 weeks post-treatment|This outcome was not analyzed due to funding issues.||||||
1388899|NCT01368263|Primary|Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy|Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.|6 months post neoadjuvant endocrine therapy and surgery|None of the participants had a PEPI score and 0 and pathological stage 1.||||||
1388900|NCT01368263|Primary|Pathologic Complete Response (CR) Rate|"In patients with Ki67 >10% and <= 15 pg/ml at 4 weeks.~The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy."|1 month|There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 >10% and estradiol levels of <= 15 pg/ml at 4 weeks.||||||
1388901|NCT01368211|Secondary|Change in Maximum Amplitude at 24-hours Post-transfusion|Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion|pre-transfusion, 24-hour post transfusion||||mm||Standard Deviation|Mean
1388902|NCT01368211|Primary|Change in Maximum Amplitude at 1-hour Post-transfusion|Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion|pre-transfusion, 1-hour post transfusion||||mm||Standard Deviation|Mean
1388903|NCT01368185|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 3.|Baseline and Month 3||||mmHg||Standard Deviation|Mean
1388904|NCT01368185|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 3.|Baseline and Month 3||||mmHg||Standard Deviation|Mean
1388905|NCT01368185|Secondary|The Percentage of Patients With Hyperuricemia|Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.|Baseline and Month 3||||percent of participants|||Number
1388910|NCT01368042|Secondary|Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from enrollment (at least 1 month after starting treatment with paricalcitol iv) through 3 months post-enrollment and 6 months post-enrollment.|Enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||pg/mL per month||95% Confidence Interval|Mean
1388911|NCT01368042|Secondary|Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months|All enrolled participants with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up).|||pg/mL||Standard Deviation|Mean
1388912|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)|Ca×P product levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg˄2/dL˄2||Standard Deviation|Mean
1388913|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)|Phosphorous levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
1388914|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)|Calcium levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
1388915|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)|Creatinine levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
1388916|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)|Urea levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
1388917|NCT01368042|Primary|Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.|Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale/month||95% Confidence Interval|Mean
1388918|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388919|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘General Health Perceptions’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388920|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Bodily Pain’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388921|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Social Functioning’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388922|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Emotional Well-Being’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388923|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey ‘Energy/Fatigue’ Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388936|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 12th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|12th month from surgery||||units on a scale||Standard Deviation|Mean
1388924|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388925|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388926|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
1388927|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..|Overactive bladder subjects answered the Overactive Bladder questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions #2 (An uncomfortable urge to urinate?); #3 (A sudden urge to urinate with little or no warning?); #4 (Accidental loss of small amounts of urine?); #7 (An uncontrollable urge to urinate?); #8 (Urine loss associated with a strong desire to urinate?) are asking about urgency. Choices for answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal); 6 (A very great deal). Multiple responses to the questionnaire was averaged per participant at baseline and at 6 weeks and then all participants answers were totaled and then averaged at baseline and at 6 weeks.|Outcome measures were assessed at baseline and after the 6 week visit.||||scores on a scale||Standard Deviation|Mean
1388928|NCT01367886|Primary|Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment|The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.|Outcome measure was assesses at baseline and at the end of the 6-week treatment period.||||scores on Urinary Sensation Scale||Standard Deviation|Mean
1388929|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.|Overactive Bladder subjects answered the Overactive Bladder Questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions # 1 (Frequent urination during the daytime hours?); #5 (Nighttime urination?) and #6 (Waking up at night because you have to urinate?) are asking about frequency. Choices of answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal) 6 (A very great deal). Multiple responses to the questionnaire were averaged for each participant at baseline and at 6 weeks and then all participants' answers were totaled and averaged at baseline and at 6 weeks.|Outcome measure was assessed at baseline and after the 6 week visit.||||scores on a scale||Standard Deviation|Mean
1388930|NCT01367886|Primary|Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment|Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.|Outcome measure was assessed at baseline and at the end of the 6-week treatment||||urinations/day||Standard Deviation|Mean
1388931|NCT01367860|Secondary|VAS for Leg Pain - 12th Month|pain scale - VAS for leg pain - 12th month|12th month from surgery||||units on a scale||Standard Deviation|Mean
1388937|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 6th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|6th month from surgery|Intention to treat|||units on a scale||Standard Deviation|Mean
1388938|NCT01367860|Primary|Oswestry Disability Index (ODI) - 3th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|3th month|Intention to treat|||units on a scale||Standard Deviation|Mean
1388939|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|1st month from baseline||||units on a scale||Standard Deviation|Mean
1388940|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Week|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|1st week minus baseline|Intention to treat|||units on a scale||Standard Deviation|Mean
1388941|NCT01367860|Secondary|VAS for Lumbar Pain - 12th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|12th month from surgery||||units on a scale||Standard Deviation|Mean
1388942|NCT01367860|Secondary|VAS for Lumbar Pain - 6th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery||||units on a scale||Standard Deviation|Mean
1388943|NCT01367860|Secondary|VAS for Lumbar Pain - 3rd Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery||||units on a scale||Standard Deviation|Mean
1388944|NCT01367860|Secondary|VAS for Lumbar 1st Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery|intention to treat|||units on a scale||Standard Error|Mean
1388945|NCT01367860|Secondary|VAS for Lumbar - 1st Week|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery||||units on a scale||Standard Deviation|Mean
1388946|NCT01367860|Secondary|Clinical Evaluation|"Will be measured dichotomously: (present or absent)~Variables:~Infection; residual pain; herniation recurrency"|6th month|Infection|||participants|||Number
1388947|NCT01367860|Primary|VAS for Lumbar Pain in 3 Months|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|VAS for Lumbar Pain at 3 Months|intention to treat|||units on a scale||Standard Deviation|Mean
1388948|NCT01367834|Secondary|Volume of Brain Lobes (Insular Cortex)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388949|NCT01367834|Secondary|Volume of Brain Lobes (Limbic)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388950|NCT01367834|Secondary|Volume of Brain Lobes (Parietal)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388951|NCT01367834|Secondary|Volume of Brain Lobes (Temporal)|Percent change in volumes of temporal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388952|NCT01367834|Secondary|Volume of Brain Lobes (Frontal)|Percent change in volumes of frontal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388953|NCT01367834|Secondary|Volume of Brain Lobes (Central)|Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388954|NCT01367834|Secondary|White Matter Tracts (SLF)|Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus|Change in FA from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388956|NCT01367834|Primary|Total Brain Volume|Percent change in total brain volume as determined by magnetic resonance imaging (MRI)|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
1388957|NCT01367704|Primary|Change From Baseline to 3 Months Using the Intentions to Intervene Scale|Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from “very unlikely” to “very likely” (minimum = 1 and maximum = 5). This scale was investigator developed by Miller (PI) et al to assess participants report of how likely they would be to do something to stop the behavior and modeled as a mean of 8 items.|3 months||||mean scores||Standard Deviation|Mean
1388958|NCT01367704|Primary|Change From Baseline to 3 Months Using the Gender Equitable Attitudes Scale|Assessment of gender-equitable attitudes comparing baseline mean score with follow up mean score, using a 5-point Likert-like scale ranging from “strongly agree” to “strongly disagree” (minimum = 1 and maximum = 5). This scale includes questions modified from Barker’s Gender-Equitable Norms Scale and modeled as a mean of responses to 11 items.|3 months||||mean scores||Standard Deviation|Mean
1388959|NCT01367704|Primary|Change From Baseline to 3 Months Using the Recognition of Abusive Behavior Scale|Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from “not abusive” to “extremely abusive” (minimum = 1 and maximum = 5). This scale was developed by Silverman et al to assess perceptions of the degree of abusiveness of specified relationship behaviors and modeled as a mean of responses to 12 items.|3 months||||mean scores||Standard Deviation|Mean
1388960|NCT01367457|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)|Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||participants|||Number
1388961|NCT01367457|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.|From initiation of treatment untill death (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||months||95% Confidence Interval|Median
1388962|NCT01367457|Primary|Duration of Response (DOR)|Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
1388963|NCT01367457|Primary|Percentage of Participants With Objective Response|Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||percentage of participants|||Number
1388964|NCT01367457|Primary|Progression-free Survival (PFS)|Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||months||95% Confidence Interval|Median
1388965|NCT01367249|Secondary|Ocular Pain|The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of “None” on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.|Day 1|LOCF Analysis, ITT Population|||eyes|Participants||Number
1388966|NCT01367249|Primary|Ocular Inflammation|The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.|Day 15|LOCF Analysis, ITT Population|||eyes|Participants||Number
1389063|NCT01366092|Secondary|Toxicity of 12-week Course of Low-dose SC IL-2 Therapy|Participants were evaluated at clinical visits for toxicities related to IL-2 throughout their 12-week treatment course|12 weeks|Grade 2 or higher, related to IL-2, adverse events (AE) were recorded for participants during their 12-week IL-2 treatment course. AE's were evaluated based on the CTCAE version 4.0.|||Grade 2 or higher related AEs|||Number
1388967|NCT01367158|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination|Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on Safety Set (all subjects in the exposed set who provided post-vaccination solicited AE data).|||Number of Subjects|||Number
1388968|NCT01367158|Secondary|Numbers of Subjects With Other Unsolicited AEs|Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|Day 8 After vaccination Through Study Termination, up to 6 months|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).|||Number of Subjects|||Number
1388969|NCT01367158|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).|||Number of Subjects|||Number
1388970|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
1388971|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
1388972|NCT01367158|Secondary|GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
1388973|NCT01367158|Secondary|GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
1388974|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
1388975|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
1388976|NCT01367158|Secondary|GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by Per MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
1388977|NCT01367158|Secondary|GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
1388978|NCT01367158|Secondary|Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT month 7 Set.|||Percentages of subjects||95% Confidence Interval|Number
1388979|NCT01367158|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.|At month 7|Analysis was done by MITT month 7 Set.|||Percentages of subjects||95% Confidence Interval|Number
1388980|NCT01367158|Secondary|GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT Month 7 Set.|||Ratio||95% Confidence Interval|Geometric Mean
1388981|NCT01367158|Secondary|GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 6 and month 7|Analysis was done by MITT Month 7 Set.|||Titers||95% Confidence Interval|Geometric Mean
1388982|NCT01367158|Secondary|Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB|At month 7|Analysis was done by MITT Month 7 Set.|||Ratio||95% Confidence Interval|Geometric Mean
1388983|NCT01367158|Secondary|Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.|||Titers||95% Confidence Interval|Geometric Mean
1388984|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.|||Percentages of subjects||95% Confidence Interval|Number
1388985|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).|At month 6 and month 7|Analysis was done by Modified Intention-To-Treat (MITT) Month 7 Set. MITT is defined as all subjects in the enrolled set who received a study vaccination at Month 6 and provided one evaluable serum sample at Month 7.|||Percentages of subjects||95% Confidence Interval|Number
1388986|NCT01367119|Secondary|Mean Post Anesthesia Recovery Side Effects|Post anesthesia recovery side effects were assessed at the time of discharge from recovery with five patient self-report items: nausea, headache, myalgia, visual disturbance, and confusion. These were rated by the patients on a four point scale (0, 1, 2, 3) – absent, mild, moderate, severe. This means that for each item a subject could score between 0 (no symptoms) and 3 (severe symptoms). Also, degree of recovery room agitation was rated by the nurse on a similar four point scale.|Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure||||units on a scale||Standard Deviation|Mean
1388987|NCT01367119|Secondary|Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression.~The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whos treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was mde to administer them 2 days after the last treatment.~Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 65 observations, for the methohexital arm there were 63 observations.|||units on a scale||Standard Deviation|Mean
1389078|NCT01365819|Primary|End of Treatment Abstinence|The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo.|9 weeks||||Participants|||Count of Participants
1388988|NCT01367119|Primary|Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)|"The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression.~The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment.~Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 54 observations, for the methohexital arm there were 55 observations.|||units on a scale||Standard Deviation|Mean
1388989|NCT01367080|Secondary|t1/2|Terminal half-time(t1/2) of Amitryptyline in Plasma|Up to 72 hours||||hour||Standard Deviation|Mean
1388990|NCT01367080|Secondary|Tmax|Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma|Up to 72 hours||||hour||Standard Deviation|Mean
1388991|NCT01367080|Secondary|Cmax|Maximum Concentration(Cmax) of amitryptyline in plasma|Up to 72 hours||||ng/mL||Standard Deviation|Mean
1388992|NCT01367080|Primary|AUClast and AUCinf|Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma|Up to 72 hours||||ng*hr/mL||Standard Deviation|Mean
1388993|NCT01366976|Secondary|Serum Creatinine|Serum creatinine measured over a 72 hour period|72 hours||||mg/dL||Standard Error|Mean
1388994|NCT01366976|Primary|Plasma F2-isoprostane Concentrations|Plasma F2-isoprostane concentrations as a measure of lipid peroxidation|24 hours||||pg/mL||Standard Error|Mean
1388995|NCT01366976|Secondary|Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)|Changes in urinary NGAL (neutrophil gelatinase-associated lipocalin) as marker of acute kidney injury|24 hours||||ng/mL||Standard Error|Mean
1388996|NCT01366976|Primary|Plasma Isofuran Concentrations|Plasma isofuran concentrations as a measure of lipid peroxidation|24 hours||||pg/mL||Standard Error|Mean
1388997|NCT01366885|Secondary|Number of Mothers Who Developed Side Effects From Vitamin D|Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.|During pregnancy and the 3 years of the child's development|The children born were assessed for whether they developed autism or not.|||participants|||Number
1388998|NCT01366885|Primary|Number of Children Who Developed Autism|The child will be screened by an Modified Checklist for Autism in Toddlers (MCHAT) interview at 18 months of age, and by a questionnaire, the Pervasive Developmental Disorder Behavioral Inventory (PDDBI) at 3 years of age to determine whether the child has developed autism or not.|Child assessed at 3 years of age|Children who developed autism|||Children who developed autism|||Number
1388999|NCT01366872|Secondary|Radiographic Predictors of Implant Failures and Poor Outcomes|Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.|A Minimum of 2 Years Post Index Procedure|Per protocol, patients who were completely revised were excluded.|||participants|||Number
1389000|NCT01366872|Secondary|Evaluation of Complication and Reoperation Rates|Number of reported complications/reoperations following the index procedure.|A Minimum of 2 Years Post Index Procedure|Per Protocol|||participants|||Number
1389001|NCT01366872|Primary|Assessment of Functional Outcomes Following Agility LP Ankle Replacement|Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.|A Minimum of 2 Years Post Index Procedure|Per surgical history (protocol).|||Degrees||Standard Deviation|Mean
1389002|NCT01366846|Secondary|Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Per Protocol|||Participants|||Count of Participants
1389003|NCT01366846|Secondary|Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Intent-to-treat|||Participants|||Count of Participants
1389026|NCT01366534|Secondary|Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge|The onset of P. falciparum parasitemia was defined by a positive blood slide.|From day of challenge (Day 0) up to 159 days post-challenge|The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.|||Days||Standard Deviation|Mean
1389004|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Per Protocol|||Participants|||Count of Participants
1389005|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|72 months|Per Protocol|||Participants|||Count of Participants
1389006|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Treatment Group|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat with available data at 72 Months|||Participants|||Count of Participants
1389007|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age – by Skin Prick Test Stratum|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat with available data at 72 months|||Participants|||Count of Participants
1389008|NCT01366638|Primary|Plasma Concentrations of TMC435|"The table below shows the median (range) TMC435 predose plasma concentrations (C0h) and maximum concentration (Cmax) values for participants in each treatment group. “Overall” is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
1389009|NCT01366638|Primary|The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h)|"The table below shows the median (range) AUC24h values for TMC435 for all participants in each TMC435 treatment group who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng·h/mL||Full Range|Median
1389010|NCT01366638|Primary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFNα-2b) and Ribavirin (RBV) at Week 24|"The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2b and RBV at Week 24. Participants in the TMC435 Treatment-Naïve and TMC435 Prior Relapser treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48 (does not apply to the TMC435 Non-responder treatment group because the specified treatment duration was 48 weeks and RGT criteria was not assessed at Week 24). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24 or 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1389027|NCT01366534|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (Day 0 - Day 236)|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.|||Participants|||Count of Participants
1390035|NCT01357720|Primary|Seroprotection Rate: Anti-PRP Antibodies|Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
1389011|NCT01366638|Primary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|"The table below shows the percentage of participants in each treatment group with greater than or equal to 2 log10 IU/mL drop from baseline in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at each time point during treatment and post-treatment follow-up. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT (up to Week 24 or 48), follow-up (FU) Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1389012|NCT01366638|Primary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT)|"The table below shows the number of participants in each treatment group with abnormal ALT levels at Baseline who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at EOT. At Baseline, 15 treatment-naïve participants, 13 prior relapsers, and 13 prior non-responders had abnormal ALT levels at Baseline. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1389013|NCT01366638|Primary|The Number of Participants Demonstrating Viral Relapse|"The table below shows the number of participants in each treatment group who demonstrated viral relapse, defined as having undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at end of treatment (EOT [Week 24 or 48]) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of an assessment of sustained virologic response (SVR). The number of participants analyzed in each treatment group below are those with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1389014|NCT01366638|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period. Viral breakthrough is defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of greater than 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 48 Weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1389015|NCT01366638|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment|"The table below shows the percentage of participants in each treatment group with undetectable HCV RNA less than 1.2 log10 IU/mL during treatment and at end of treatment (EOT). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1389016|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|"The table below shows the percentage of participants in each treatment group with a SVR24 defined as participants with undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment and at 24 weeks after the last dose of treatment (Week 48 or 72). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|24 weeks after the last dose of treatment (Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1389017|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|"The table below shows the percentage of participants in each treatment group with an SVR12 defined as participants with undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma HCV RNA 12 weeks after the last dose of treatment (Week 36 or 60). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of Participants|||Number
1389018|NCT01366534|Secondary|Frequency of CS-specific T-cells Producing IFN-γ|The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) N-terminal assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs).|14 days post-dose 1 (Day 14)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||spots/million PBMCs||Standard Deviation|Mean
1389019|NCT01366534|Secondary|Frequency of CS-specific T-cells Producing IFN-γ|The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||spots/million PBMCs||Standard Deviation|Mean
1389020|NCT01366534|Secondary|Frequency of HBs-specific CD4+ T-cells|HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||T-cells/million PBMCs||Standard Deviation|Mean
1389021|NCT01366534|Secondary|Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells|CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||T-cells/million PBMCs||Standard Deviation|Mean
1389022|NCT01366534|Secondary|Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells|CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||T-cells/million PBMCs||Standard Deviation|Mean
1389023|NCT01366534|Secondary|Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1389024|NCT01366534|Secondary|Anti-hepatitis B (Anti-HBs) Antibody Titers|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1389025|NCT01366534|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Titers|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1389046|NCT01366521|Primary|Time to Maximum Change in Blood Eosinophils Levels (Tmaxeos)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the time to first occurrence of maximum reduction from baseline in blood eosinophil levels between Day 1 pre-dose and last quantifiable study measurement.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population.|||Days||95% Confidence Interval|Mean
1389028|NCT01366534|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Day 0 - Day 29) follow-up period post-challenge|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.|||Participants|||Count of Participants
1389029|NCT01366534|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1389030|NCT01366534|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors [uncontrollable shivering more than (>) 15 seconds]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Day 0 – Day 6) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.|||Participants|||Count of Participants
1389031|NCT01366534|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Day 0 – Day 6) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.|||Participants|||Count of Participants
1389032|NCT01366534|Primary|Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge|P. falciparum parasitemia was defined as a positive blood slide.|28 days following sporozoite challenge (Day 105)|The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.|||Participants|||Count of Participants
1389033|NCT01366521|Secondary|Mean Dose Normalized Cmax Ratio to Assess the Relative Bioavailability of SC Mepolizumab as Compared With IV Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed dose-normalized (DM) Cmax were be analyzed using an analysis of variance (ANOVA) model. The ratio for each SC dose group versus IV and across SC doses versus IV will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Percentage||90% Confidence Interval|Mean
1389034|NCT01366521|Secondary|Mean AUC to Assess the Absolute Bioavailability of SC Mepolizumab|Population modelling techniques using non-linear mixed effect methods were used to estimate individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed individual clearance estimates were analysed using an analysis of variance (ANOVA) model. The absolute bioavailability for each SC dose group and across SC doses will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population|||Percentage||90% Confidence Interval|Mean
1389035|NCT01366521|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening (SCR) and Day 3 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and at Day 3|Safety Population|||Participants|||Number
1389036|NCT01366521|Secondary|Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies by antibody detection (AD) and antibody neutralisation (AN) assay. For participants who prematurely withdrew from the study and had been dosed, immunogenicity testing occurred (if possible) at the time of premature withdrawal and at 16 weeks after dosing (or the end of the study, whichever came first). Serum was tested for the presence of anti-mepolizumab antibodies using the currently approved analytical methodology incorporating screening, confirmation and titration steps. Samples confirmed positive for the presence of anti-mepolizumab antibodies in the original assay were tested for the presence of neutralizing antibodies.|Day 1, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Participants|||Number
1389037|NCT01366521|Secondary|Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including heart rate (HR) was measured at Baseline (Pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||beats per minute (BPM)||Standard Deviation|Mean
1389038|NCT01366521|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Baseline (pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1389039|NCT01366521|Secondary|Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment|Hematology laboratory parameters included platelet count, red blood cells (RBC) count, white blood cell (WBC) count, hemoglobin, hematocrit, reticulocyte count, mean corpuscle volume (MCV), mean corpuscle hemoglobin (MCH), mean corpuscle hemoglobin concentration (MCHC), neutrophils, segmented neutrophils (SN), total neutrophils (TN), lymphocytes, monocytes, eosinophils and basophils assessed at Baseline, Weeks 4, 8, 12 and 20. Hematology abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 (follow-up visit)|Safety Population|||Participants|||Number
1389040|NCT01366521|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment|Clinical chemistry laboratory parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB) and direct bilirubin, creatinine, chloride, uric acid, glucose, total carbondioxide (CO2), gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP) and total protein assessed at Baseline, Weeks 4, 8, 12 and 20. Laboratory abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Baseline (Day 1 pre-dose), Weeks 4, 8, 12 and 20|Safety Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Participants|||Number
1389041|NCT01366521|Primary|Terminal Half-life (t½) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Terminal half-life (t1/2) was estimated by modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters for mepolizumab from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population|||Days||95% Confidence Interval|Mean
1389042|NCT01366521|Primary|Time to Maximum Plasma Concentration (Tmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Time to maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||hours||Full Range|Median
1389043|NCT01366521|Primary|Maximum Plasma Concentration (Cmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1389044|NCT01366521|Primary|Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab|AUC of mepolizumab was estimated by population modeling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Individual cumulative plasma of mepolizumab AUC to Day 84 (cumAUC(0-day 84)), is the sum of the AUCs over each dosing interval after each of the three doses administered, for those participants with data up to Day 84. Individual cumulative plasma of mepolizumab AUC to Day 140 (cumAUC(0-day 140) is the sum of the AUCs over each dosing interval after each of the three doses administered plus the AUC post the last dose interval up to Day 140 (i.e. from Day 84 to Day 140). Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 hour (h), 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|Pharmacokinetic (PK) Population: all participants randomized to treatment and who received at least one dose of study treatment and who have at least one PK sample taken and analyzed. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Nanogramper milliliter per hour(ng*h/mL)||95% Confidence Interval|Geometric Mean
1389045|NCT01366521|Primary|Number of Participants Who Achieved >=50% Eosinophil Repletion by Day 140|This summarizes the number of participants who returned to at least 50% of their Baseline blood eosinophil levels after maximum inhibition had been achieved and without any subsequent decrease in blood eosinophil levels. Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population|||Participants|||Number
1389047|NCT01366521|Primary|Maximum Change From Baseline in Blood Eosinophils (Emax)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the maximum reduction from Baseline in blood eosinophils between Day 1 pre-dose and last quantifiable study measurement. Change from Baseline was calculated as the ratio of the post-Baseline value divided by the Baseline value. The maximum reduction from Baseline in eosinophils is represented by the minimum ratio to Baseline.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population|||Giga units per liter (GI/L)||95% Confidence Interval|Geometric Mean
1389048|NCT01366521|Primary|Area Under the Blood Eosinophil Time Curve (AUEC) up to Day 84|Area under the absolute blood eosinophil time curve to Day 84 (AUECeos[0-day 84]) determined using the linear trapezoidal rule for subset of participants with blood eosinophil data to Day 84. Blood samples for the analyses of AUEC(eos) (0-day 84) were collected at Days 1, 3, 7, 28, 56, 70 and 84.|Days 1, 3, 7, 28, 56, 70 and 84|PD Population. Only participants with eosinophil data to Day 84 were analyzed.|||Giga unit per liter per day (GI*d/L)||95% Confidence Interval|Geometric Mean
1389049|NCT01366521|Primary|Change From Baseline in Blood Eosinophil Levels at Week 12 (Day 84)|Change from Baseline in blood eosinophils was calculated as the post-Baseline value minus the Baseline value. The change from Baseline in log-transformed blood eosinophil levels at Week 12 was analyzed using both a linear and non-linear (Imax) dose response models. The dose response was found to be non-linear and hence only the results of the non-linear model are presented. Mepolizumab 75mg IV assumed to equate to 100 mg SC within model. Prior to log10-transformation, zero values were imputed with half the minimum value across all dose groups and time points. An adjustment for Baseline eosinophil count was also incorporated into the model.|Baseline (Day 1 pre-dose) and Week 12|Pharmacodynamic (PD) Population: all participants randomized to treatment and who received at least one dose of study medication and who also had a Baseline PD or biomarker measurement and at least one post-treatment PD or biomarker measurement. Only participants who were available at the specified time point were analyzed.|||Proportion of Baseline blood eosinophil||95% Confidence Interval|Number
1389050|NCT01366443|Primary|Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus|Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.|1 week|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes who underwent all three assessments.|||participants|||Number
1389051|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.|10 minutes after treatment|Subjects whose Treatment Day Baseline bacterial counts met qualification criteria|||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
1389052|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.|30 seconds after treatment|subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments.|||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
1389053|NCT01366209|Primary|Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52||52 weeks|Intent to Treat all randomized Patient|||percentage of patients|||Number
1389054|NCT01366196|Other Pre-specified|Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1|Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.|Postoperative Day 1 with Physical Therapy||||units on a scale||Standard Deviation|Mean
1389055|NCT01366196|Other Pre-specified|Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest|Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.|Postoperative Day 1 at rest||||units on a scale||Standard Deviation|Mean
1389056|NCT01366196|Other Pre-specified|Numerical Pain Rating Scale Score on Day of Surgery|Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.|Day of Surgery||||units on a scale||Standard Deviation|Mean
1389057|NCT01366196|Secondary|Oral Analgesic Supplementation Use|Tabulate number of patients that used supplemental oral analgesics|Day of surgery||||Participants|||Count of Participants
1389058|NCT01366196|Primary|Patient Controlled Analgesia (PCA) Hydromorphone Usage||Postoperative day 1||||mL||Standard Deviation|Mean
1389059|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The ratio between CD4+CD25+FOXP3+ regulatory T cells (Treg) and CD4 conventional T cell (Tcon) counts were measured.|16 weeks of study follow-up||||ratio||Inter-Quartile Range|Median
1389060|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The CD4+CD25+FOXP3+ regulatory T cells (Treg) counts were measured.|16 weeks of study follow-up||||cell count/ uL||Inter-Quartile Range|Median
1389061|NCT01366092|Secondary|Overall Survival and Progression-free Survival|Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. OS was defined as from the study entry to death from any cause. Patients who were alive or lost to follow-up were censored at the time last seen alive. PFS was defined from the study entry to disease relapse or progression or death from any cause, whichever occurred first.|2 years from start of IL-2||||probability|||Number
1389062|NCT01366092|Secondary|Prednisone Taper With IL-2 Therapy|Participants had their steroid dose assessed at weeks 6, 12,16, and every 8 weeks while on extended duration IL-2 therapy.|End of treatment after 16 weeks or most recent follow-up date for patients on extended|Participant's steroid taper was measured using their steroid dose at the start of therapy and their dose at the end of 16 weeks. For participants who continued on extended duration therapy, their final steroid dose was determined at the time of stopping treatment or, if still ongoing, the last clinic visit at the time of data analysis.|||percent taper||Full Range|Mean
1389064|NCT01366092|Primary|Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD|Participants were evaluated according to the cGVHD NIH Consensus criteria at baseline, 6 weeks, and 12 weeks on study. Per cGVHD NIH Consensus criteria, cGVHD involved organ systems are given a grade 0-3 and an overall cGVHD score, from 0-10, is given. Complete Response is defined as resolution of all reversible manifestations in each organ or site of cGVHD. A partial response is defined as an improvement in measure at least one organ or site, or decrease in global ratings by at least a 2-point change on the 10-point scale, without progression measured at any other organ or site. Non-responders have no change in cGVHD meeting criteria for either partial response or disease progression. Progressive disease is defined as an increase in organ or site scales (1-point change on a 3-point scale) or 2- to 3-point increase on the global cGVHD ratings. Clinical worsening of cGVHD is not synonymous with progressive cGVHD per NIH criteria.|Baseline, 6 weeks, and 12 weeks|33 of 35 patients were evaluable for response criteria. To be evaluable, patients had to receive at least 6 weeks of daily IL-2 and had their disease re-assessed.|||participants|||Number
1389065|NCT01365910|Secondary|Number of Patients With Each Worst‐Grade Toxicity|"Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1= mild; grade 2 = moderate; grade 3 = severe; grade 4 = life‐threatening; grade 5 = death~Assessed: days 1 &15 of cycle 1; day 1 of each subsequent 28-day cycle; at 30-day follow-up for two years"|date on‐study up to 2 years following final dose of study|Total number of patients reported with any toxicity|||participants|||Number
1389066|NCT01365910|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1389067|NCT01365910|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring. Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1389068|NCT01365910|Primary|Overall Response Rate (Complete Response + Partial Response) With a Target of at Least 15%|Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Defined as the CR + PR recorded from the start of the treatment until disease progression/recurrence, the exact two-sided 95% confidence intervals will be reported.|Baseline and every 8 weeks, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||percentage of target lesions||95% Confidence Interval|Median
1389069|NCT01365845|Secondary|Assessment of Cardiac Function Markers|Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.|after treatment|||||||
1389070|NCT01365845|Secondary|Assessment of Longterm Side Effects and Disease Specific End Points.|"Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies.~Analyze local control, progression-free survival, and overall survival."|1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.|||||||
1389071|NCT01365845|Secondary|Assessment of Acute Side Effects|Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.|Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.|||||||
1389072|NCT01365845|Secondary|Secondary Dosimetric Endpoint|Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.|2 weeks prior to starting radiation therapy.|||||||
1389073|NCT01365845|Primary|Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)|A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.|2 weeks prior to starting radiation therapy.||||% of heart receiving >= 5 Gray (Gy)||Full Range|Median
1389074|NCT01365819|Other Pre-specified|Reduction in Cigarette Smoking|3) To determine whether varenicline reduces cigarette smoking more than placebo among cigarette smoking MA dependent participants.|9 weeks|This analysis includes a sub-population of participants in both conditions who smoked any cigarettes during treatment. Results are model fitted number of cigarettes smoked per week at baseline and at week 9.|||average number of cigarettes|average number of cigarettes|Standard Deviation|Mean
1389075|NCT01365819|Other Pre-specified|Reduced MA Withdrawal Symptoms|2) To determine whether varenicline reduces MA withdrawal symptoms more than placebo among MA- dependent participants over the course of the trial.|9 weeks|This outcome was not assessed.||||||
1389076|NCT01365819|Other Pre-specified|Prevalence of Relapse Following Initiation of Abstinence During Treatment|1) The number of participants who achieve MA abstinence and subsequently relapse to MA use during treatment by condition (varenicline, placebo) during the outpatient treatment period.|7 weeks|This analysis presents the number of participants in each condition who achieved abstinence during treatment and later relapsed.|||Participants|||Count of Participants
1389077|NCT01365819|Secondary|Number of Days Retained in Trial|Secondary aims will compare treatment retention among participants randomly assigned to receive varenicline or placebo|9 weeks|This outcome was not assessed.||||||
1403454|NCT01234103|Primary|Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies||6 to 9 months|No data were collected from participants. Participants only attended intervention sessions.||||||
1389079|NCT01365793|Secondary|Intelligence Quotient (IQ) Testing|IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome.|3 months|All randomized subjects aged 3 years and older with 3-month follow-up and successful completion of IQ testing.|||IQ points||Standard Deviation|Mean
1389080|NCT01365793|Secondary|Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.|Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item’s border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome.|3 months|All randomized subjects aged 6 years old and older with 3-month follow-up and successful completion of memory score tests, and d-prime (a measure of chance agreement) >0.50|||Item-context association rate||Standard Deviation|Mean
1389081|NCT01365793|Secondary|Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)|The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first.|24 hours|All randomized patients with digit span measured during DKA|||Digit Span Change per Hour||Standard Error|Mean
1389082|NCT01365793|Secondary|Frequency of Clinically Apparent Brain Injury|Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.|24 hours|All randomized patients.|||Participants|||Count of Participants
1389083|NCT01365793|Primary|the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)|The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.|24 hours|Patients with a GCS of 14 or 15 at randomization|||Participants|||Count of Participants
1389084|NCT01365650|Primary|MRT (the Mean Residence Time)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||hours||Standard Deviation|Mean
1389085|NCT01365650|Primary|t1/2z (the Terminal Half-life, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||hours||Standard Deviation|Mean
1389086|NCT01365650|Primary|AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||ng*h/mL||Standard Deviation|Mean
1389087|NCT01365650|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||ng*h/mL||Standard Deviation|Mean
1389088|NCT01365650|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||hours||Full Range|Median
1389089|NCT01365650|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||ng/mL||Standard Deviation|Mean
1389090|NCT01365624|Primary|MRT (Mean Residence Time)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.|||hours||Standard Deviation|Mean
1389091|NCT01365624|Primary|t1/2z (Terminal Half-life)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.|||hours||Standard Deviation|Mean
1389092|NCT01365624|Primary|AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.|||ng*hours/mL||Standard Deviation|Mean
1389093|NCT01365624|Primary|AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose||||ng*hours/mL||Standard Deviation|Mean
1389094|NCT01365624|Primary|Tmax (Time to Reach Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose||||hours||Full Range|Median
1389095|NCT01365624|Primary|Cmax (Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
1389096|NCT01365611|Primary|MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.|||hours||Standard Deviation|Mean
1389097|NCT01365611|Primary|t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.|||hours||Standard Deviation|Mean
1389098|NCT01365611|Primary|AUC Inf (the AUC From Time Zero to Infinity, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.|||ng*hours/mL||Standard Deviation|Mean
1389099|NCT01365611|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine).||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6||||ng*hours/mL||Standard Deviation|Mean
1389100|NCT01365611|Primary|Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6||||hours||Full Range|Median
1389101|NCT01365611|Primary|Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6||||ng/mL||Standard Deviation|Mean
1389102|NCT01365585|Secondary|Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4|Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1389103|NCT01365585|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4|PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
1389104|NCT01365585|Secondary|Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4|CI: calculated as COsys divided by BSA.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
1389105|NCT01365585|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4|PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
1389106|NCT01365585|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4|mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
1389107|NCT01365585|Secondary|Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4|RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
1389108|NCT01365585|Secondary|Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4|NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. Here, 'n' included those participants who were evaluable for this measure at specified time points.|||participants|||Number
1389109|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
1389110|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 3|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
1389111|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 2|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
1389112|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 1|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
1389113|NCT01365546|Secondary|Post-operative Efficacy Assessment|Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration|up to 30 days||||participants|||Number
1389114|NCT01365546|Secondary|Assessment of Intra-operative Hemostatic Efficacy|The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy.|1 Day||||participants|||Number
1389115|NCT01365546|Primary|Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale.|Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results (‘secondary adjudication’) and adjudicated the surgeons’/investigators’ assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments (‘primary adjudication’). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures).|30 Days||||participants||95% Confidence Interval|Number
1389116|NCT01365507|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
1389179|NCT01364896|Primary|Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types|Anal (and vaginal for female participants) HPV PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) using the SYBR-Green-based real-time PCR assay with a reverse line blot assay for genotyping of HPV in the positive samples and Taqman probe-based real-time PCR assays for quantification of individual HPV subtypes|Baseline and 6 to 12 months||||participants|||Number
1389117|NCT01365507|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
1389118|NCT01365507|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Events/100 years of patient exposure|||Number
1389119|NCT01365507|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects baseline values were missing, hence not included in the analysis.|||mmol/L||Standard Deviation|Mean
1389120|NCT01365507|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1389121|NCT01365494|Secondary|Percentages of Subjects Reporting Adverse Events (AEs)|Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.|All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period|Safety population- All subjects in the Exposed population who provide post vaccination safety data and as vaccinated (as treated)|||percentages of subjects|||Number
1389122|NCT01365494|Secondary|Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations|Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules|Day 0, Day 7, Day 14 and Day 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized|||IU\ml||95% Confidence Interval|Geometric Mean
1389123|NCT01365494|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42|Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Study day 7, 14 and 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized|||Percentages of Subjects|||Number
1389124|NCT01365494|Primary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule|On Day 0 and Day 14|Per Protocol Set-All subjects in the FAS (Full analysis set) population who:correctly receive the vaccine, provide evaluable serum sample at day 14, and have no major protocol violation as defined prior to analysis|||IU/mL||95% Confidence Interval|Geometric Mean
1389125|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point|Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication.that has Chronic Kidney Disease (CKD)|||Percentage of patients|||Number
1389126|NCT01365481|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.|||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
1389127|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point|Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication that has Chronic Kidney Disease (CKD) only|||Percentage of patients|||Number
1389128|NCT01365481|Secondary|Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height|Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height|End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. This analysis includes only participants with baseline MSSBP or MSDBP or (MSSBP or MSDBP combined) ≥95th percentile for gender, age and height. n analyzed is displayed in left column. This OM did not break up the analysis between CKD and non-CKD patients.|||Number of Participants|||Number
1389129|NCT01365481|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.|||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
1389130|NCT01365468|Other Pre-specified|Physician’s Global Assessment of Clinical Condition (PGA) of Skin Lesions|The Physician‟s Global Assessment of Clinical Condition (PGA) is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the patient‟s skin disease as compared to baseline. Responses must be confirmed by at least two assessments separated in time by at least 4 weeks. The grading ranges from 0 to 6; 0 is Completely clear where as 6 is for worse condition. A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement.|Screening, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.||||||
1389131|NCT01365468|Other Pre-specified|Number of Patients With Clinical Response|Clinical response is defined as improvement of function, performance status, or decrease in PN related pain persisting for at least 28 days on treatment.|Screening, Day 1, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.||||||
1389132|NCT01365468|Primary|Number of Patients With Adverse Events Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) V.04|Adverse events were assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to grades 1 - 4 respectively, were used. CTCAE grade 5 (death) was not used in this study.|From the time ICF was signed until 28 days after End of Treatment (up to a maximum of 25 months)|The Safety Population consisted of all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.|||Patients|||Number
1389133|NCT01365468|Primary|Number of Patients With Objective Radiographic Responses Based on Volumetric MRI Measurements (In Stratum 2 Only)|"Response was assessed at the time that a follow up volumetric MRI scan is performed (after course 6 and then every 6 months and at the end of treatment).~Complete response (CR): complete resolution of all measurable or palpable PN for ≥ 28days and no appearance of new lesions.~Partial response (PR): A ≥ 20% reduction in the sum of the volume of all index PN lesions for ≥ 28days.~Stable disease (SD): A ‹ 20% increase and ‹ 20% decrease in the sum of the volume of all index PN lesions for ≥ 28days."|Screening, after course #6, then every 6 months and end of treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.|||Patients|||Number
1389134|NCT01365468|Primary|Time to Disease Progression (TTP) Based on Change in Volumetric MRI Measurements in Children and Adults (In Stratum I Only)|This endpoint was planned to be analyzed for only Stratum 1 patients. Progression of disease defined as a ≥ 20% increase in the volume (by volumetric MRI) of at least one of the index plexiform neurofibromas (PN) compared to the pretreatment volume measured prior to the start of the current treatment phase.|Screening, after course #6, #12, #18, #24, End of Treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.|||Days||95% Confidence Interval|Median
1389135|NCT01365455|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant’s ability to respond to secukinumab treatment.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||participants|||Number
1389136|NCT01365455|Secondary|Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy|PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)& severity is estimated by clinical signs, erythema,induration & desquamation;scale 0(none) to 4(max). Final PASI=sum of severity parameters for each area* area score weight of section(head:0.1,arms:0.2 body:0.3 legs:0.4).PASI 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
1389173|NCT01364922|Secondary|Participant’s Global Assessment of Back Pain Status at Final Evaluation|"The participant’s overall impression of their back pain status was obtained by having the participant answer the question Considering all the ways your chronic low back pain affects you, how are you doing today? on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)."|Double-blind baseline to Day 29||||participants|||Number
1389137|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24,36, & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
1389138|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 4, 8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
1389139|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24, 36 & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||95% Confidence Interval|Median
1389140|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 4, 8 & 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||95% Confidence Interval|Median
1389141|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Week 12, 24, 36, 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||Standard Deviation|Mean
1389142|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, Week 4,8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||percent change||Standard Deviation|Mean
1389180|NCT01364870|Primary|Self-reported Pain With Walking (From Iowa Gait Test)|"Subjects are instructed to walk as quickly as they safely can for 15 seconds. Their pain was assessed with a Numeric Rating Scale (where 0 is no pain and 20 is pain as bad as you can imagine)."|2 days post-op||||scores on a scale||Full Range|Median
1389143|NCT01365455|Secondary|Time to PASI 75 Response up to 12 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 was defined as participants achieving ≥ 75% improvement from baseline.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||days||Inter-Quartile Range|Median
1389144|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
1389145|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
1389146|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent change||Standard Deviation|Mean
1389147|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||Standard Deviation|Mean
1389148|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
1389174|NCT01364922|Primary|Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.|Double-blind baseline to Day 29|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat) and had at least 1 assessment during the double-blind period.|||scores on a scale||Standard Error|Least Squares Mean
1389175|NCT01364896|Primary|Number of Participants With High-grade Anal Dysplasia Lesions|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months||||participants|||Number
1389149|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
1389150|NCT01365455|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. A reduction in score from baseline shows efficacy. Each question has a score of 0 (no symptoms) up to 10 (Severe symptoms)|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Scores on a Scale||Standard Error|Mean
1389151|NCT01365455|Secondary|Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||number of participants|||Number
1389152|NCT01365455|Secondary|Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||number of participants|||Number
1389153|NCT01365455|Secondary|Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 was defined as participants who achievied ≥ 90% improvement from baseline.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
1389154|NCT01365455|Primary|Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
1389176|NCT01364896|Primary|Number of Participants Who Had One or More Anal Biopsies|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months||||participants|||Number
1389177|NCT01364896|Primary|Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)|High-resolution anoscopy with anal cytology testing|Baseline and 6 to 12 months||||participants|||Number
1389155|NCT01365455|Primary|Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
1389156|NCT01365273|Primary|VAS Score for Pain After Dressing Removal|"Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.|||units on a scale||Standard Deviation|Median
1389157|NCT01365273|Primary|VAS Score for Pain During Dressing Removal|"Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All included subjects to post-randomization treatment and that provided some data for the primary endpoint was included in the Intention To Treat analyses.|||units on a scale||Standard Deviation|Median
1389158|NCT01365273|Primary|VAS Score for Pain Before Dressing Removal|"Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = no pain at one end to 100 = most intense pain imagaginable at the other end."|At visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.|||units on a scale||Standard Deviation|Median
1389159|NCT01365130|Secondary|Number of Patients Experienced a Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.|CTCAE version 4. It is noted that the time frame was approximately 7 months, taking into account the total amount of treatment patients received on this trial.|During treatment and through 30 days post treatment, approximately 7 months|Number of patients who experienced a toxicity on the trial. Not all toxicities may be related to study treatment.|||Participants|||Count of Participants
1389160|NCT01365130|Primary|Number of Patients Without Progression at 3 Months|Response will be assessed via RECIST 1.1 criteria|every three cycles approx every 63 days||||participants|||Number
1389161|NCT01365091|Primary|AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area Under the Concentration-time Curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable|||ng*h/mL||Standard Deviation|Mean
1389162|NCT01365091|Secondary|Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1|All enrolled participants who receive study medication|||Participants|||Number
1389163|NCT01365091|Primary|AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area under the concentration-time curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable|||pg*h/mL||Standard Deviation|Mean
1389164|NCT01365091|Primary|Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets||Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable|||μg/mL||Standard Deviation|Mean
1389165|NCT01365052|Other Pre-specified|Treatment Compliance - Duration of Exposure to Treatment in Days||10 days after randomization|Safety population|||Days||Standard Deviation|Mean
1389166|NCT01365052|Other Pre-specified|Treatment Compliance - Number of Capsules Taken||10 days after randomization|Safety population|||Capsules||Standard Deviation|Mean
1389167|NCT01365052|Primary|Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in AE section|10 days after randomization|Safety population|||Percentage of participants|||Number
1389168|NCT01365052|Primary|Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in Adverse Events (AE) section|10 days after randomization|Safety population|||Percentage of participants|||Number
1389169|NCT01365052|Other Pre-specified|Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product||10 days after randomization|Safety population|||Percentage of participants|||Number
1389170|NCT01365039|Primary|High Contrast, Distance logMAR Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint|4 visits over 3 months|All Eligible, Dispensed Eyes|||logMAR|Participants|Standard Deviation|Mean
1389171|NCT01365039|Primary|Slit Lamp Findings > Grade 2|Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses|4 visits over 3 months|Over All Follow-up Visits, Eyes with Findings > Grade 2 (All Dispensed Eyes)|||eyes|Participants||Number
1389172|NCT01364922|Secondary|Participant’s Global Assessment of Study Drug at Final Evaluation|"The participant’s overall impression of the study drug was obtained by having the participant answer the question How would you rate your overall response to the study medication? on a 5-point categorical scale: excellent; very good; good; fair; poor."|Double-blind baseline to Day 29|Double-blind intent to treat population; scores for participants with no post-randomization assessment were excluded from this analysis.|||participants|||Number
1389187|NCT01364727|Secondary|Disease Control Rate (DCR)|"Disease control rate (DCR) is the sum of Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate , and is expressed here as the sum of the Overall Response Rate (ORR = CR + PR) plus the Stable Disease (SD) rate, ORR + SD.~Response was assessed by the RECIST criteria, elaborated above."|2 years|Includes those participants with Complete Response (CR) plus those with Partial Response (PR), plus those with Stable Disease).|||Participants|||Count of Participants
1389188|NCT01364727|Secondary|Median Progression-free Survival (PFS)|Median Progression-free survival in patients with thymic malignancies treated with amrubicin|2 years|Some participants (2) continue to survive without progression, although a median and the 95% confidence interval (95% CI) for the 33 participants have been defined.|||Months||95% Confidence Interval|Median
1389189|NCT01364727|Primary|Overall Response Rate (ORR)|"Participants received amrubicin 35 mg/m2 IV days 1 to 3, every 3 weeks, until progression or toxicity.~Tumor response rate was assessed radiographically by the Response Evaluation Criteria In Solid Tumors (RECIST), and the overall response rate (ORR) was expressed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.~RECIST criteria define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:~CR = Disappearance of all target lesions~PR = 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions~Stable disease (SD) = Small changes that do not meet above criteria"|2 years|Includes those participants with Complete Response (CR) plus those with Partial Response (PR).|||Participants|||Count of Participants
1389190|NCT01364649|Secondary|Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved.|Baseline and Weeks 1, 2, 4, 6 and 8|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. Last observation carried forward.|||number of participants|||Number
1389191|NCT01364649|Secondary|Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline and Weeks 1, 2, 4 and 6|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.|||scores on a scale||Standard Error|Least Squares Mean
1389192|NCT01364649|Primary|Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.|||scores on a scale||Standard Error|Least Squares Mean
1389193|NCT01364584|Secondary|Echocardiographic Measures - Lateral E:E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||ratio||Standard Deviation|Mean
1389194|NCT01364584|Secondary|Echocardiographic Measures - Lateral E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
1389195|NCT01364584|Secondary|Echocardiographic Measures - Septal E:E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||ratio||Standard Deviation|Mean
1389196|NCT01364584|Secondary|Echocardiographic Measures - Septal E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
1389197|NCT01364584|Secondary|Echocardiographic Measures - Mitral Valve Deceleration Time|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||milliseconds||Standard Deviation|Mean
1389198|NCT01364584|Secondary|Echocardiographic Measures - Mitral Valve E:A Wave Velocity|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
1389199|NCT01364584|Secondary|Echocardiographic Measures - Mitral Valve E Wave Velocity|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
1389203|NCT01364584|Secondary|Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise|Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.|Baseline and 3 months|Data not collected||||||
1389204|NCT01364584|Secondary|Change From Baseline in Peak Dilation of Brachial Artery Diameter|Change in the response of the brachial artery to hyperemia will be assessed before and after 3 months of study medication or placebo.|Baseline and 3 months||||millimeters||Standard Deviation|Mean
1389205|NCT01364584|Secondary|Change From Baseline in Arterial Stiffness|Pulse wave velocity will be measured via sphygmocor before and after 3 months of study medication or placebo.|Baseline and 3 months|Data unable to be collected on all participants, hence the difference between the overall number of participants analyzed here and the actual number of participants who completed the study|||meters/second||Standard Deviation|Mean
1389206|NCT01364584|Secondary|Oxygen Uptake Kinetics Steady State Tau|Time to steady state oxygen consumption will be assessed in subject before and after 3 months of study medication or placebo.|Baseline and 3 months||||seconds||Standard Deviation|Mean
1389207|NCT01364584|Primary|Peak Oxygen Consumption (VO2 Peak)|Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.|Baseline and 3 months||||milliliters per kilogram per minute||Standard Deviation|Mean
1389208|NCT01364558|Primary|Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations.|"To calculate bioavailability we used the following formula:~Area Under the Curve (Intranasal Spray)*100/Area Under the Curve (Intravenous Injection)"|2 days||||Percentage of Bioavailability||90% Confidence Interval|Geometric Mean
1389209|NCT01364428|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1389210|NCT01364428|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1389211|NCT01364428|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1389212|NCT01364428|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 22 weeks of treatment.|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 5 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
1389213|NCT01364428|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 22 weeks of treatment|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1389214|NCT01364389|Secondary|Effect on Health-related Quality of Life||6 months|||||||
1389215|NCT01364389|Secondary|Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885||6 months|||||||
1389216|NCT01364389|Secondary|Pharmacokinetics of AIN457 and ACZ885||Day 15|||||||
1389217|NCT01364389|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths||6 months|Safety analysis set: This set included all participants who received at least one dose of study medication.|||Participants|||Number
1389218|NCT01364389|Secondary|Cumulative and/or Mean Steroid Dose Over a 6 Month Period||6 months|||||||
1389219|NCT01364389|Secondary|Number of Flares Over a 6 Month Period||6 months|||||||
1389220|NCT01364389|Secondary|Time to First Flare||6 months|||||||
1389221|NCT01364389|Secondary|Time to Complete Clinical Response|The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: >70% reduction in patient global assessment VAS compared with baseline, morning stiffness < 30 min, CRP < 1.0 mg/dL and/or ESR < 30 mm/1st hr.|Day 15|PD analysis set|||Percentage of participants|||Number
1389222|NCT01364389|Secondary|Time to Partial Clinical Response|"The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had:~>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness < 60 minutes."|Day 15|PD analysis set|||Percentage of participants|||Number
1389223|NCT01364389|Primary|Polymyalgia Rheumatica Activity Score (PMR-AS)|The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient’s elevation on upper limbs, patient’s assessment of pain, and physician’s global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants.|Baseline, Day 15|Pharmacodynamic (PD) Analysis Set: This set included participants who received at least one dose of study medication and had no major protocol deviation that may impact the PD data.|||Percent reduction||Standard Error|Least Squares Mean
1389224|NCT01364298|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 7 up to Day 84 (+7 days)|Safety population included all the randomized participants who received at least one dose of study drug.|||participants|||Number
1389225|NCT01364298|Secondary|Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)|NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.|||percentage of participants|||Number
1389226|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale|CGIC is an assessment that the physician performs to assess the participant’s global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1389227|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale|GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1389228|NCT01364298|Secondary|Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration|Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12).|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.|||participants|||Number
1389229|NCT01364298|Secondary|Profile of Mood States (POMS) Score|"POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means not at all and 4 extremely. The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score."|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.|||units on a scale||Standard Deviation|Mean
1389230|NCT01364298|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84|VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||centimeter||Standard Deviation|Mean
1389231|NCT01364298|Secondary|Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84|The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The ﬁrst 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their signiﬁcance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||units on a scale||Standard Deviation|Mean
1404212|NCT01227785|Primary|Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported at 1-month post-implant|1-month|73 CRT-D patients had data available at 1-month visit|||Ohms||Standard Deviation|Mean
1389232|NCT01364298|Primary|Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84|An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||units on a scale||Standard Deviation|Mean
1389233|NCT01364259|Secondary|Pain Relief Following Radiosurgery|Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication)|1 year|8 subjects were enrolled on the Amifostine arm, however, one subject was enrolled but withdrew prior to treatment.|||Participants|||Count of Participants
1389234|NCT01364259|Primary|Facial Numbness Following Radiosurgery|Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.|1 year|One subject randomized to drug arm did not have data.|||Participants|||Count of Participants
1389235|NCT01364207|Primary|Change in Intraocular Pressure at 90 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion~At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.|||mm Hg||Standard Deviation|Mean
1389236|NCT01364207|Primary|Change in Intraocular Pressure at 60 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion~At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.|||mm Hg||Standard Deviation|Mean
1389237|NCT01364090|Secondary|Behavioral and Quality of Life|Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.|48 weeks|||||||
1389238|NCT01364090|Secondary|Treatment Response (ETR & SVR24)|Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.|48 weeks|||||||
1389239|NCT01364090|Secondary|Treatment Adherence|Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|48 weeks|||||||
1389240|NCT01364090|Secondary|Safety and Tolerability|Evaluate the safety and tolerability of directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|48 weeks|||||||
1389241|NCT01364090|Primary|Treatment Efficacy|The primary outcome measure is the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|36 weeks||||participants|||Number
1389242|NCT01363986|Secondary|Brain Progression-Free Survival (B-PFS)|B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|Due to the premature interruption of the study and the small number of enrolled participants (3 nerolled), all participant data were listed only, without any descriptive statistics or data analysis. The endpoint of B-PFS was thus not analyzed.||||||
1389243|NCT01363986|Secondary|Overall Survival|The number of participants surviving at the final visit.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|ITT population; survival status of 1 participant was unknown at the final visit.|||participant|||Number
1390272|NCT01354145|Secondary|Synovial Fluid Volume|To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||mililiters||Standard Deviation|Mean
1389244|NCT01363986|Secondary|Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit|Brain objective response was defined as either a CR or PR), provided that there was no increase in steroid requirements, or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment|ITT population; 1 participant was not assessed at the final visit.|||participant|||Number
1389245|NCT01363986|Secondary|Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15|Brain objective response was defined as either a CR or PR, provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)|ITT population; 2 participants were not assessed at Cycle 15.|||participants|||Number
1389246|NCT01363986|Primary|Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7|Brain objective response was defined as either a complete response (CR) or partial response (PR), provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all central nervous system (CNS) lesions. PR was defined as a greater than or equal to (≥) 30 percent (%) reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])|ITT population; 1 participant was not assessed at Cycle 7.|||participants|||Number
1389247|NCT01363908|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were assessed to determine if a participant was a successful responder and were determined from serum biochemistry analyses conducted at the central laboratories. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||ng/mL||Standard Deviation|Mean
1389248|NCT01363908|Secondary|Change From Baseline in Cardiac Iron Load Assessed by T2* MRI|The efficacy of SPD602 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||milliseconds||Standard Deviation|Mean
1389249|NCT01363908|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
1389250|NCT01363908|Secondary|Change From Baseline in LIC Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
1389251|NCT01363908|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
1389252|NCT01363908|Primary|Change From Baseline in Liver Iron Concentration (LIC) Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The Full Analysis Set (FAS), defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
1389253|NCT01363908|Primary|Fraction Of Orally Administered Drug Excreted Unchanged In Urine (fe) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||percentage of total dose||Standard Deviation|Mean
1389254|NCT01363908|Primary|Amount Excreted Into Urine (Ue) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||mg||Standard Deviation|Mean
1389255|NCT01363908|Primary|Renal Clearance (CLr) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||L/h||Standard Deviation|Mean
1389256|NCT01363908|Primary|Terminal Half-life (t1/2) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||hours||Standard Deviation|Mean
1389257|NCT01363908|Primary|Area Under The Plasma Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||h*mg/L||Standard Deviation|Mean
1389258|NCT01363908|Primary|Time of Maximum Observed Plasma Concentration Sampled During a Dosing Interval (Tmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||hours||Full Range|Median
1389259|NCT01363908|Primary|Maximum Observed Plasma Concentration (Cmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The Pharmacokinetic (PK) set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable. The Safety Analysis Set was defined as all participants who had taken at least 1 dose of investigational product. Treatment assignment was based on the treatment actually received.|||ng/mL||Standard Deviation|Mean
1389260|NCT01363843|Secondary|Evaluate the Toxicity of Study Therapy|"Evaluate the toxicity of induction FOLFOX and subsequent infusional 5-FU or capecitabine/radiation.~•Secondary efficacy measures include the clinical response rate, as measured endorectal ultrasound or pelvic MRI, and incidence and severity of toxicities seen during the various phases of study treatment, including treatment delays, bleeding and post-op complications. Each visit will have a toxicity assessment completed"|approx 1 year|||||||
1389261|NCT01363843|Primary|Incidence of Complete Resection|The primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine|approx 6 months||||participants|||Number
1389262|NCT01363765|Secondary|NRR of Negative-laboratory TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.~Numbers are driven from linkage between lab (all tests done) and notification databases; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.~Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)||||notifications/100,000 persons/year||95% Confidence Interval|Number
1389277|NCT01363661|Secondary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).|The results are expressed mean relative change (%) between month 6 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 6. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -200% and the maximum observed was +6100%.|Month 6|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
1389263|NCT01363765|Secondary|NRR of Non-laboratory Tested TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.~Numbers are participants in the notification database who were not in the lab (all tests done) database; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.~Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)|The result is the notification rate ratio|||notifications/100,000 persons/year||95% Confidence Interval|Number
1389264|NCT01363765|Primary|Costs Per Detected Case|Costs per detected case were analyzed using a decision tree model from the national health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated as (costs with Xpert - costs with smears)/(cases detected with Xpert - cases detected with smears). Negative ICERs mean cost saving.|October 2012 (up to 2 years)||||American dollars|||Number
1389265|NCT01363765|Primary|Notification Rate Ratio|Proportion of additional bacteriologically confirmed notified TB cases during intervention period compared to the observation period Patients notified who had a positive test result. The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.|October 2012 (up to 2 years)|Only patients found both in laboratory and in the notification databases were included since this is an outcome based on notification rates. Population growth during time was estimated. NR per 100,000 population|||notifications/100,000 persons/year||95% Confidence Interval|Number
1389266|NCT01363713|Other Pre-specified|Change in Bulbar Conjunctiva Hyperemia Score by Visit|"Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week||||score||Standard Error|Mean
1389267|NCT01363713|Other Pre-specified|Change in Palpebral Hyperemia Score by Visit|"Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week||||score||Standard Error|Mean
1389268|NCT01363713|Primary|Change in Ocular Itching Score by Visit|"Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week||||score||Standard Error|Mean
1389269|NCT01363700|Secondary|Mean Hyperemia Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 7 (5, 10, and 20 minutes post-CAC)||||score||Standard Error|Mean
1389270|NCT01363700|Secondary|Mean Ocular Itching Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 7 (3, 5, and 10 minutes post-CAC)||||score||Standard Error|Mean
1389271|NCT01363700|Primary|Mean Hyperemia Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 5 (5, 10, and 20 minutes post-CAC)||||score||Standard Error|Mean
1389272|NCT01363700|Primary|Mean Ocular Itching Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 5 (3, 5, and 10 minutes post-CAC)||||score||Standard Error|Mean
1389273|NCT01363661|Secondary|Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population|||Number of events|||Number
1389274|NCT01363661|Secondary|Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population|||Number of events|||Number
1389275|NCT01363661|Secondary|Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).||Month 12|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
1389276|NCT01363661|Secondary|Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).|The results are expressed mean relative change (%) between month 6 or month 12, and baseline. A positive result means improvement in the augmentation index between baseline and month 6 or month 12. It could be considered as a surrogate of a decrease of the arterial stiffness. A negative percentage means the inverse. The are no fixed limits to the scale. At month 6,the minimum observed was -139% and the maximum observed was +1600%.At month 12, the minimum observed was -524% and the maximum observed was +1600%.|Month 6 and Month 12|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
1389278|NCT01363661|Primary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).|The results are expressed mean relative change (%) between month 12 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 12. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -275% and the maximum observed was +4200%.|12 months|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
1389279|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter pNN50||Baseline to week 55||||msec||Standard Deviation|Mean
1389280|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter rMSSD||Baseline to week 55||||msec||Standard Deviation|Mean
1389281|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter SDNN||Baseline to week 55||||msec||Standard Deviation|Mean
1389282|NCT01363492|Secondary|Change From Baseline in Urine Gb3||Baseline to week 55||||(nmol/g creatinine)||Standard Deviation|Mean
1389283|NCT01363492|Secondary|Change From Baseline in Plasma Gb3||Baseline to week 55||||(nmol/mL)||Standard Deviation|Mean
1389284|NCT01363492|Secondary|Change From Baseline in MFS||Baseline to week 55||||(%)||Standard Deviation|Mean
1389285|NCT01363492|Secondary|Change From Baseline in LVMI||Baseline to week 55||||(g/m^2.7)||Standard Deviation|Mean
1389286|NCT01363492|Primary|Development of IgG Anti-Agalsidase Alfa Antibody|Reflects development of Anti-Agalsidase antibodies post baseline|Baseline to Week 55||||participants|||Number
1389287|NCT01363492|Primary|Number of Treatment Emergent Adverse Event (TEAE)||Baseline to week 55||||events|||Number
1389288|NCT01363492|Primary|Number of Serious Adverse Event (SAE)||Baseline to week 55||||events|||Number
1389289|NCT01363479|Secondary|Proportion of Patients With no Rescue Medication||0-24 hours|||||||
1389290|NCT01363479|Secondary|Proportion of Patients With no Emesis||0-24 hours|||||||
1389291|NCT01363479|Primary|Proportion of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication||0-24 hours|Full Analysis Set i.e. patients receiving study drugs and chemotherapy|||percentage of responders||95% Confidence Interval|Number
1389292|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline and Week 52||||scores on a scale||Standard Error|Least Squares Mean
1389293|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline and Week 52||||scores on a scale||Standard Error|Least Squares Mean
1389294|NCT01363440|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline and Week 52||||microns||Standard Error|Least Squares Mean
1389295|NCT01363440|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline and Week 52||||percentage of participants|||Number
1389296|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52||||percentage of participants|||Number
1389297|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52|All secondary efficacy endpoints were analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).|||percentage of participants|||Number
1389298|NCT01363440|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.|Baseline and Week 52|The Primary efficacy endpoint was analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).|||letters correctly read||Standard Error|Least Squares Mean
1389299|NCT01363401|Secondary|Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)|"The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score presents more severe disability. The higher the score presents less disability.~This was measured at Visit 5 and Visit 9. (week 0,16) The first injection was performed at 0 week.~The score variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|The SF-36 was assessed except Two participants of no treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.|||point||Standard Deviation|Mean
1389333|NCT01363076|Primary|Cmax (the Maximum Observed Plasma Concentration)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng/mL||Standard Deviation|Mean
1389300|NCT01363401|Secondary|Change in Forced Vital Capacity (FVC) (Percent of Predicted Normal)|"Secondary efficacy was measured by comparing the rate of decline of mean FVC by treatment group.~FVC which is a clinical scale to observe variation in patient’s respiratory competence, was conducted at Visit 1, Visit 5 and Visit 9. (week -12,0,16) The first injection was performed at 0 week. FVC variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|"One of the test group, FVC was assessed except because received tracheostomy during the clinical trial.~FVC was assessed except Two participants of no treatment group because 1) ICU admissions for breathing therapy 2) Patients reject the measurement"|||percent of prediceted||Standard Deviation|Mean
1389301|NCT01363401|Secondary|Change in Appel Scale|"To evaluate the disease change, Appel scale will be assessed. Appel scale is a test tool, which is devised to evaluate the functional condition and variation of ALS(Lou Gehrig’s disease) patients (rating 6 to between 30 and 36 points for each of 5 functional conditions, 30-164 total).~The higher the total score presents more severe disability. This was done at Visit 1, Visit 5 and Visit 9 (week -12,0,16). The first injection was performed at 0 week(Visit 5) Appel scale total score variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|Apple scale was assessed except Two participants of No treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.|||point||Standard Deviation|Mean
1389302|NCT01363401|Primary|The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale – Revised (ALSFRS-R) Between Treatment Groups and Control Groups.|ALSFRS-R is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. ALSFRS-R was evaluated at baseline and week 28.(The first injection was performed at 0 week) ALSFRS-R total score variation baseline(Visit 5) and week 16(Visit 9)|baseline(Visit 5) and week 16(Visit 9)|The ALSFRS-R score was assessed by all the subjects in Phase 1/2 clinical trials.|||score on a scale||Standard Deviation|Mean
1389303|NCT01363349|Secondary|Long Term Schizophrenia Treatment|Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment|Baseline and 6, 12 and 24 weeks of treatment|||||||
1389304|NCT01363349|Secondary|Long Term Cognition|Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment|12 and 24 weeks of treatment|||||||
1389305|NCT01363349|Primary|Cognition|To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.|Baseline and 6 weeks|Analysis for MCCB Score ITT population.|||Scores on a scale||Standard Deviation|Mean
1389306|NCT01363297|Secondary|Messenger Ribonucleic Acid (mRNA) Gene Expression|Optional blood samples for pharmacogenomic parameters were collected during Cycle 1 prior to the start of the inotuzumab ozogamicin infusion (0 hours) and 1 hour post-dose (original Final Protocol and Protocol Amendments 1 and 2) or 3 hours post-dose (Protocol Amendments 3 and 4) on Day 1 and Day 15 from those participants who provided consent. Gene expression analysis of samples collected pre- and post-dosing was performed using 96-gene TaqMan® low density array cards to examine the concordance between clinical outcome and expression of genes such as those involved in DNA damage response, apoptosis, B-cell antigen expression, glutathione metabolism, drug transport and the phosphoinositide 3-kinase/mammalian target of rapamycin pathway. Expression for each gene was reported as a normalized value, 2^–change in (∆) threshold cycle (Ct), where ∆Ct is Ct^target gene minus Ct^reference genes, averaged.|Predose and postdose on Days 1 and 15 of Cycle 1|Pharmacogenomics population - included all enrolled participants who received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.|||Fold expression||Full Range|Median
1389307|NCT01363297|Secondary|Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit|CD22+ leukemic blasts assessed in abnormal B cells from bone marrow (data from central laboratories only).|Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4|Safety analysis set|||Percentage of CD22+||Full Range|Median
1389308|NCT01363297|Secondary|Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit|CD22+ leukemic blasts assessed in abnormal B cells from blood (data from central laboratories only).|Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4|Safety analysis set|||Percentage of CD22+||Full Range|Median
1389309|NCT01363297|Secondary|Duration of Follow-Up|Duration of follow-up was defined as the time from the date of first dose of study drug to the date of last contact for participants known to be alive.|From first dose up to approximately 2 years|Participants who were alive|||Months||95% Confidence Interval|Median
1389310|NCT01363297|Secondary|Time to MRD Negativity for Participants Who Achieved CR or CRi|Time to MRD negativity was defined as the time from the date of first dose of study drug to the date of first documentation of MRD negativity.|Screening, Day 21 of Cycles 1 to 6 and up to 4 to 6 weeks after the last dose (up to 34 weeks)|All participants who achieved CR/CRi and MRD negativity.|||Days||Full Range|Median
1389311|NCT01363297|Secondary|Time to Response for Participants Who Achieved CR/CRi or PR|Time to response was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic response (CR, CRi, or PR).|Up to approximately 2 years from first dose|All participants who achieved CR, CRi or PR.|||Days||Full Range|Median
1389312|NCT01363297|Secondary|Time to Remission for Participants Who Achieved CR or CRi|Time to remission was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic remission (CR or CRi) in participants achieving remission during study therapy.|Up to approximately 2 years from first dose|All participants who achieved CR or CRi|||Days||Full Range|Median
1389313|NCT01363297|Secondary|Overall Survival (OS)|OS was defined as the time from Cycle 1 Day 1 to date of death due to any cause. If death was not documented, censoring occurred at the date at which the participant was last known to be alive.|Up to approximately 2 years from first dose|Safety analysis set|||Months||95% Confidence Interval|Median
1389314|NCT01363297|Secondary|Duration of Response (DoR) for Participants Who Achieved CR/CRi or PR|DoR was defined for participants who respond as the time from the date of first documentation of Hematologic Response (CR, CRi, or PR) to the date of the first documentation of DoR event (earliest date of PD, treatment discontinuation due to global deterioration of health status, first induction therapy or transplant after PR, relapse after CR or CRi or death due to any cause). Participants last known to be 1) alive and 2) without a DoR event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|All participants who achieved CR, CRi or PR.|||Weeks||95% Confidence Interval|Median
1389315|NCT01363297|Secondary|Duration of Remission (DoR1) for Participants Who Achieved CR or CRi|DoR1 was defined for participants who responded as the time from the date of first documentation of Complete Hematologic Response (CR or CRi) to the date of the first documentation of relapse after CR or CRi, treatment discontinuation due to global deterioration of health status) or to death due to any cause. Participants last known to be 1) alive and 2) without a DoR1 event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|All participants who achieved CR or CRi|||Months||95% Confidence Interval|Median
1389316|NCT01363297|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from Cycle 1 Day 1 to first documentation of PFS event (earliest date of objective progression [PD], treatment discontinuation due to global deterioration of health status, subsequent induction or transplant after best response of PR or resistant disease, relapse after CR or CRi, or death due to any cause). Participants last known to be 1) alive and 2) without a PFS event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|Safety analysis set|||Months||95% Confidence Interval|Median
1389317|NCT01363297|Secondary|Percentage of Participants Who Had a Post-Treatment Stem-Cell Transplant (SCT)|Post-treatment SCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin.|Up to approximately 2 years from first dose|Safety analysis set|||Percentage of Particicpants|||Number
1389318|NCT01363297|Secondary|Percentage of Participants With CR or CRi by Cytogenetic Category|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set (n refers to number of participants evaluated)|||Percentage of Participants|||Number
1389319|NCT01363297|Secondary|Number of Participants With Minimal Residual Disease (MRD) Negativity in Participants Achieving CR and CRi|MRD negativity was defined as <0.01% mononuclear cells.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Number of participants who achieved CR and CRi|||Participants|||Number
1389320|NCT01363297|Secondary|Percentage of Participants With CR, CRi or PR in Phase 2|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Partcicipants||95% Confidence Interval|Number
1389321|NCT01363297|Primary|Percentage of Participants With CR, CRi or PR During the Phase 1 Expansion Phase|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Partcicipants||95% Confidence Interval|Number
1389322|NCT01363297|Primary|Percentage of Participants With CR or CRi During Phase 2|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Partcicipants||90% Confidence Interval|Number
1389323|NCT01363297|Primary|Percentage of Participants With Preliminary Satisfactory Response (Complete Response [CR], CR With Incomplete Count Recovery [CRi], Partial Response [PR], or Resistant Disease [RD]) Indicating Disease Stability After First Dose During Phase 1 Dose-Finding|CR was the disappearance of leukemia indicated by <5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was as for CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was an improved or no worsening of acute lymphocytic leukemia indicated by no peripheral blood blasts, and/or at least a 50% decrease in the marrow blast percentage, compared to pre-treatment value, and marrow blast percentage ≥5% and less than or equal to (≤)25% and/or C2 extramedullary disease status. RD occurred if a participant survived ≥7 days following completion of initial treatment course and had persistent leukemia in the most recent peripheral blood smear or bone marrow and/or persistent disease involvement at any extramedullary site after completion of therapy.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Participants|||Number
1389615|NCT01361633|Secondary|Controlled Oral Word Association Test|Measure of a person's ability to make verbal associations to specified letters.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1389324|NCT01363297|Primary|Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase|DLT was any of the following in the first cycle & attributable to inotuzumab ozogamicin: any greater than or equal to (≥) Grade 4 non-hematologic toxicity except nausea/vomiting (if manageable with supportive care), alopecia, & toxicities secondary to neutropenia & sepsis; prolonged myelosuppression (absolute neutrophil count [ANC] less than [<] 500 per microliter [/µL] or platelet count <25,000/µL in bone marrow with <5 percent (%) blasts & no evidence of leukemia more than 45 days beyond the most recent dose of test article); any Grade 3 non-hematologic toxicity (excluding toxicities such as alopecia or those secondary to neutropenia & sepsis) not resolving to ≥ Grade 2 within 7 days of the most recent dose of test article or was clinically significant irrespective of duration; any ≥ Grade 3 elevation of alanine aminotransferase, aspartate aminotransferase or bilirubin lasting ≥7 days; any test article related toxicity resulting in permanent discontinuation of test article.|Cycle 1|Safety analysis set|||Percentage of Participants|||Number
1389325|NCT01363258|Secondary|Oral Health|The oral health will be measured as the total score obtained from the Oral Health Assessment Tool. The OHAT contains 8 categories (e.g., status of gums, dentition, moisture of oral cavity, general cleanliness, etc.). Each category is assigned a value of 0=healthy, 1=problematic, and 2=unhealthy. Scores range from 0 (healthy) to 16 (unhealthy).|Baseline (observation) to follow-up (week 3)||||units on a scale||Standard Error|Mean
1389326|NCT01363258|Primary|Care-Resistant Behavior|"Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say no, etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 mild behaviors or 4 severe behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25."|Baseline (observation) to follow-up (week 3)|One-hundred nine NH residents were enrolled; 101 were randomized, 100 contributed data for analyses, and 91 completed the 3-week intervention period.|||units on a scale||Standard Error|Mean
1389327|NCT01363076|Primary|MRT (Mean Residence Time)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||hr||Standard Deviation|Mean
1389328|NCT01363076|Primary|t1/2 (the Terminal Half-life, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||hr||Standard Deviation|Mean
1389329|NCT01363076|Primary|AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng•h/mL||Standard Deviation|Mean
1389330|NCT01363076|Primary|AUCinf (the AUC Time From Zero to Infinity, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. AUCinf calculated as: AUCinf = AUC(0-24) + (concentration at 24 hr/elimination constant).|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng•h/mL||Standard Deviation|Mean
1389331|NCT01363076|Primary|AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng•h/mL||Standard Deviation|Mean
1389332|NCT01363076|Primary|Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. Individual plasma ketorolac concentrations were summarized by dose level for the PK population at each sampling time using n, arithmetic mean, SD, CV(%), geometric mean, 95% confidence intervals (CI) for the arithmetic mean, median, minimum, and maximum.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||hr||Full Range|Median
1389345|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)|Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||hours||Inter-Quartile Range|Median
1389334|NCT01363050|Primary|MRT (the Mean Residence Time|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Standard Deviation|Mean
1389335|NCT01363050|Primary|AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng*hours/mL||Standard Deviation|Mean
1389336|NCT01363050|Primary|Tmin,ss (the Time to Minimum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Full Range|Median
1389337|NCT01363050|Primary|Cmin,ss (the Minimum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng/mL||Standard Deviation|Mean
1389338|NCT01363050|Primary|Tmax,ss (the Time to Maximum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Full Range|Median
1389339|NCT01363050|Primary|Cmax,ss (the Maximum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng/mL||Standard Deviation|Mean
1389340|NCT01363050|Primary|AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng*hours/mL||Standard Deviation|Mean
1389341|NCT01363050|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Full Range|Median
1389342|NCT01363050|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng/mL||Standard Deviation|Mean
1389343|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)|t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||hours||Inter-Quartile Range|Median
1389344|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)|t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||hours|||Number
1389616|NCT01361633|Secondary|Continuous Performance Test|Assesses Sustained Attention|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
1389346|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)|Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||hours|||Number
1389347|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)|Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||ng/mL||Standard Deviation|Mean
1389348|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)|Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||ng/mL|||Number
1389349|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)|Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||ng/mL||Standard Deviation|Mean
1389350|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)|Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||ng/mL|||Number
1389351|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)|AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||h*ng/mL||Standard Deviation|Mean
1389352|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)|AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||h*ng/mL|||Number
1389353|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)|Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
1389354|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)|Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)|||percentage of participants|||Number
1389355|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 2)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Safety Analysis Set (treatment-experienced only)|||percentage of participants|||Number
1389356|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1389357|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1389358|NCT01363011|Primary|Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|PK/PD Substudy Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.|||mL/min||Inter-Quartile Range|Median
1389359|NCT01363011|Primary|Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|Pharmacokinetic/Pharmacodynamic (PK/PD) Substudy Analysis Set (treatment-naive only): participants in the treatment-naive group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.|||mL/min|||Number
1389360|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389361|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389362|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 1)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)|||percentage of participants|||Number
1389363|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-experienced participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
1389364|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-naive participants in the Full Analysis Set with available data was analyzed.|||percentage of participants|||Number
1389365|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389366|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389367|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389368|NCT01363011|Primary|Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389369|NCT01363011|Primary|Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389370|NCT01363011|Primary|Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389371|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389372|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389373|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1389374|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
1392829|NCT01330953|Secondary|Number of Participants Forming Antibody to LY2928057||Baseline through Day 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and antibody titer results.|||participants|||Number
1389375|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Week 48|Participants in the Safety Analysis Set (treatment-experienced only) with available data were analyzed.|||mL/min||Inter-Quartile Range|Median
1389376|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min||Inter-Quartile Range|Median
1389377|NCT01363011|Primary|Change From Baseline in eGFR-CG at Week 24 (Cohort 2)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).|Baseline; Week 24|Safety Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug|||mL/min||Inter-Quartile Range|Median
1389378|NCT01363011|Primary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).|Baseline; Week 24|Safety Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug|||mL/min||Inter-Quartile Range|Median
1389379|NCT01362946|Secondary|Overall Treatment Recommendation - Parent|At end end of both treatment blocks, parents selected which treatment they though was best for their child - standard behavioral treatment or modified behavioral treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.|||percentage of participants|||Number
1389380|NCT01362946|Secondary|Overall Treatment Recommendation - Counselor|At end end of both treatment blocks, counselors sorted children into one of four treatment response groups: (1) responded best to standard behavior therapy; (2) responded best to modified behavior therapy; (3) responded well to both treatments; (4) did not respond to either treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.|||percentage of participants|||Number
1389381|NCT01362946|Secondary|Overall Effectiveness|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate how effective this treatment was in changing your child as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (this treatment much less effective) to 4 (this treatment much more effective)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
1389382|NCT01362946|Secondary|Overall Satisfaction|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate your overall satisfaction with this treatment as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (much less satisfied with this program) to 4 (much more satisfied with this program)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
1389383|NCT01362946|Secondary|Recommend Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you recommend this treatment to other parents?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
1389384|NCT01362946|Secondary|Would You Send Your Child to This Treatment Again?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you send your child to this treatment if you could do it over again?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
1389385|NCT01362946|Secondary|How Much Did Your Child Enjoy the Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
1389409|NCT01362907|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale||Standard Deviation|Mean
1389386|NCT01362946|Secondary|How Much Did You (the Parent) Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did you benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
1389387|NCT01362946|Secondary|How Much Did Your Child Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
1389388|NCT01362946|Secondary|WPRF Overall Problems - Parent|"At the end of each treatment week parents rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389389|NCT01362946|Secondary|WPRF Overall Problems - Counselor|"At the end of each treatment week counselors rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389390|NCT01362946|Secondary|WPRF Rule Following Problems - Parent|"At the end of each treatment week parents rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389391|NCT01362946|Secondary|WPRF Rule Following Problems - Counselor|"At the end of each treatment week counselors rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389392|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Parent|"At the end of each treatment week parents rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389393|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Counselor|"At the end of each treatment week counselors rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389394|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Parent|"At the end of each treatment week parents rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389395|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Counselor|"At the end of each treatment week counselors rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389423|NCT01362608|Secondary|Percent Patients Who Took Rescue Medication||12 weeks|FAS|||percentage|||Number
1389424|NCT01362608|Secondary|Time to First Rescue Medication Intake||12 weeks|FAS|||hours||Standard Deviation|Mean
1389396|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Parent|"At the end of each treatment week parents rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389397|NCT01362946|Primary|Minutes of Physical Management|Counselors recorded the total number of minutes children had to be physically managed due to behavior dangerous to themselves or others. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Minutes of Physical Manage per day||Standard Error|Least Squares Mean
1389398|NCT01362946|Primary|Number of Time Outs|Counselors recorded the total number of Time Outs children served due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of Time Outs per day||Standard Error|Least Squares Mean
1389399|NCT01362946|Primary|Minutes in Time Out|Counselors recorded the total number of minutes children were in Time Out due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Minutes in Time Out per day||Standard Error|Least Squares Mean
1389400|NCT01362946|Primary|Positive Peer Behavior|Counselors recorded each instance of positive behavior with peers, defined as helping, sharing and ignoring teasing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of positive peer behave per day||Standard Error|Least Squares Mean
1389401|NCT01362946|Primary|Rule Violations|Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of rule violations per day||Standard Error|Least Squares Mean
1389402|NCT01362946|Primary|Noncompliance|Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of noncompliance per day||Standard Error|Least Squares Mean
1389403|NCT01362946|Primary|Interruption|Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of interruptions per day||Standard Error|Least Squares Mean
1389404|NCT01362946|Primary|Complaining|Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of complaints per day||Standard Error|Least Squares Mean
1389405|NCT01362946|Primary|Negative Verbalizations|Counselors recorded each instance of negative verbalizations, defined as verbal abuse to staff, teasing peers, and swearing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of negative verbals per day||Standard Error|Least Squares Mean
1389406|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Counselor|"At the end of each treatment week counselors rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
1389407|NCT01362946|Primary|Conduct Problems|Counselors recorded each instance of conduct problems, defined as lying, stealing, intentional destruction of property, and intentional aggression. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of conduct problems per day||Standard Error|Least Squares Mean
1389408|NCT01362907|Secondary|Overall Lens Fit|As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale|Participants|Standard Deviation|Mean
1389425|NCT01362608|Secondary|Time to Complete Resolution of Pain: Survival Analysis by Treatment|Kaplan Meier estimate|12 weeks|Full analysis set|||hours||95% Confidence Interval|Median
1389410|NCT01362907|Primary|Overall Vision Quality|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale||Standard Deviation|Mean
1389411|NCT01362907|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale||Standard Deviation|Mean
1389412|NCT01362907|Primary|Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)|As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||logMAR|Participants|Standard Deviation|Mean
1389413|NCT01362894|Secondary|Ease of Selecting Final Lens Power|As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.|Day 0|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
1389414|NCT01362894|Primary|Overall Satisfaction|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
1389415|NCT01362894|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
1389416|NCT01362894|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
1389417|NCT01362894|Primary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
1389418|NCT01362686|Secondary|Healthy Aging Brain Care (HABC)-Monitor|The current HABC-Monitor includes 30 items covering four clinically relevant domains of dementia, ie, cognitive, functional, behavioral, and psychological symptoms, and caregiver quality of life. For brevity and practical use in the clinical setting, each item on the four scales was designed to have the same item response options consisting of four categories that use the frequency of the target problem in the past 2 weeks. The HABC- Monitor took approximately 6 minutes to complete. The scores of the four scales are summed to create the total scores which were used in this analysis.The higher the total score, the higher the level of self reported caregiver burden. The minimum score is 0 and the maximum score is 90.|baseline, 6, 12, and 18 week interviews||||units on a scale||Standard Deviation|Mean
1389419|NCT01362686|Secondary|Neuropsychiatric Inventory (NPI)|The NPI is based on a structured interview administered to an informal caregiver and has been adopted by the Alzheimer’s Disease Cooperative Studies Group to obtain information on the presence of psychopathology in behavioral areas including delusions, apathy, hallucinations, disinhibition, agitation, depression, aberrant motor behavior, anxiety, night-time behavior, and euphoria.9 For each of 12 symptoms, if the caregiver reports the presence of psychopathology, a frequency and severity score are multiplied to yield a possible item score range of 0–12, and a possible total score range of 0–144. The NPI can be used to assess changes in the patient’s behavior over the past month. The NPI also assesses the level of caregiver distress attributable to each of the 12 patient behaviors, with a possible total caregiver distress score range of 0–60. Higher scores indicate higher severity of psychopathology and caregiver disress. The NPI has excellent reliability and validity.|Baseline, 6, 12, 18 week interviews from enrollment||||units on a scale||Standard Deviation|Mean
1389420|NCT01362686|Primary|Discontinuation Rates|We are not seeking to establish efficacy of these three medications for the indication of Alzheimer’s disease. Each of these medications already has FDA-approval for Alzheimer’s. The primary outcome measure is the discontinuation rate among the three medications. Based on previous systematic reviews, these rates are reportedly in the range of 30% by 12 weeks compared with placebo. We will determine the approximate date of discontinuation by self-reports from the caregiver through the telephone-based interview at 6, 12, and 18 weeks.|6, 12, and 18 week interviews from enrollment||||participants|||Number
1389421|NCT01362608|Secondary|High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose||72 hours post dose||||mg/L||95% Confidence Interval|Mean
1389422|NCT01362608|Secondary|Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.|Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.|12 weeks|FAS|||mg||Standard Deviation|Mean
1389427|NCT01362608|Secondary|Physician’s Assessment of Range of Motion: Frequency Table by Timepoint and Treatment|Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).|baseline through week 12|Full Analysis Set|||participants|||Number
1389428|NCT01362608|Secondary|Physician’s Assessment of Erythema: Frequency Table by Timepoint and Treatment|Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set|||participants|||Number
1389429|NCT01362608|Secondary|Physician’s Assessment of Swelling: Frequency Table by Timepoint and Treatment|Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set|||participants|||Number
1389430|NCT01362608|Secondary|Physician’s Assessment of Tenderness: Frequency Table by Timepoint and Treatment|Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set|||participants|||Number
1389431|NCT01362608|Secondary|Patient’s Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.|Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).|72 hours through week 12|Full Analysis Set|||participants|||Number
1389432|NCT01362608|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment|Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).|baseline through week 12|Full Analysis Set|||participants|||Number
1389433|NCT01362608|Secondary|Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0–100mm VAS): Summary Statistics by Timepoint and Treatment|A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)|baseline through 12 weeks|Full Analysis set|||unit on a scale||Standard Deviation|Mean
1389434|NCT01362608|Secondary|The Number of Patients With at Least 1 New Gout Flare||12 weeks||||participants|||Number
1389435|NCT01362608|Primary|Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis|Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks|12 weeks|Full Analysis Set|||Participants||95% Confidence Interval|Number
1389436|NCT01362608|Primary|The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)|A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)|at 72 hours post-dose|Full Analysis set|||units on a scale||Standard Error|Least Squares Mean
1389437|NCT01362530|Secondary|Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
1389438|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
1389439|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1|Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the acute phase of Cycle 1.|0 to 24 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
1389440|NCT01362530|Primary|Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.|25 to 120 hours after the start of chemotherapy|Intent-to-treat (ITT) population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
1389441|NCT01362517|Secondary|Safety: Adverse and Serious Adverse Events|Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection|From Day 1 up to 30 days after the third vaccination||||Number of children with AE per 100 doses|Participants||Number
1389442|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 14 months (equivalent to 12 months after the first vaccination|Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up|||percentage of subjects||95% Confidence Interval|Number
1389443|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 5 months (equivalent to 1 month after the third vaccination)|Analysis population excludes one subject excluded as a protocol violator|||percentage of subjects||95% Confidence Interval|Number
1389444|NCT01362491|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief|1, 2, & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1389445|NCT01362491|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|1, 2, 3 hours post-dose|ITT population included all randomized patients who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1389446|NCT01362491|Secondary|Duration of Relief|Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first.|0 to 3 hours|Population included all randomized patients that reported a treatment failure or received rescue medication.||||||
1389447|NCT01362491|Secondary|Cumulative Percentage of Participants With First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1389448|NCT01362491|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1389449|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
1389450|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
1389451|NCT01362491|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
1389452|NCT01362491|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
1389453|NCT01362491|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
1389454|NCT01362491|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
1389455|NCT01362491|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1389705|NCT01360996|Primary|Biochemical Assessment of Hyperandrogenism|"The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units.~FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100"|24 weeks||||Index||Standard Deviation|Mean
1389456|NCT01362491|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1389457|NCT01362491|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1389458|NCT01362491|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0-3 Hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
1389459|NCT01362439|Secondary|Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores|Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe).|Baseline and Week 13|Safety population included all participants who received atleast one dose of study medication.|||units on a scale||Standard Deviation|Mean
1389460|NCT01362439|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.|Baseline and Week 13|ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389461|NCT01362439|Secondary|Quality of Sleep Score|This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389462|NCT01362439|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389463|NCT01362439|Secondary|Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.|||units on a scale||Full Range|Median
1389464|NCT01362439|Secondary|Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13|The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as – 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389970|NCT01358357|Secondary|Time to All-cause Discontinuation||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||Days||95% Confidence Interval|Median
1389465|NCT01362439|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13|The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389466|NCT01362439|Secondary|Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. 'N' (number of participants analyzed) signified participants evaluable for this measure.|||percentage of participants|||Number
1389467|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389468|NCT01362439|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389469|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
1389470|NCT01362439|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|Intent to Treat Population (ITT) included all participants who received at least 1 dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using Last observation carried forward (LOCF) method.' N' (number of participants analyzed): participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1389471|NCT01362348|Secondary|Summary of Plasma Pazonib Concentration|Throughout the study, 1 to 4 blood samples (2 mL) were collected from each participants for the analysis of plasma pazopanib concentrations between 0.55 to 10.83 hours post-dose on Weeks 2, 3, 4, 6 (unplanned), 8 (unplanned) and 12. The concentrations from the three blood samples per participant were averaged and then the values were averaged through all the participants. Blood samples were collected without restriction for the time interval between blood draw and the last dose of pazopanib eye drops.|Up to Week 12|Pharmacokinetic Population was defined as participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Standard Deviation|Mean
1389472|NCT01362348|Secondary|Number of Participants With Abnormal Urinalysis Data by Urine Microscopy and Dipstick Analysis|Urinalysis measurements included assessments for red blood cells and white blood cells via microscopic examination while assessments for urine protein by standard dipstick analysis. Data has been presented for the number of participants with abnormal urinalysis results.|Up to Follow-up (Day 102)|Safety Population. Only those participants available at the specified time points were analyzed,|||Participants|||Count of Participants
1389473|NCT01362348|Secondary|Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern|Clinical chemistry parameters included albumin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, direct bilirubin, total bilirubin, calcium, chloride, carbon dioxide, creatinine, thyroxine (T3 free), gamma glutamyl transferase, glucose, potassium, sodium, total protein, total T3, urea, uric acid while hematology included basophils, eosinophils, hemoglobin, hematocrit, lymphocytes, mean corpuscle hemoglobin concentration, mean corpuscle hemoglobin, mean corpuscle volume, monocytes, segmented neutrophils, total neutrophils, platelet count, red blood cell count, reticulocytes and white blood cell count. The potential clinical concern ranges were as follows: glucose-low <3 and high >9 millimoles per liter (mmol/L), carbon dioxide-low <18 and high >34 mmol/L, lymphocyte-low <0.8 giga per liter (G/L) and platelet count was <100 and high >550 G/L. Data has been presented for the number of participants with values high and low of potential clinical concern.|Up to Follow-up (Day 102)|Safety population.|||Participants|||Count of Participants
1389474|NCT01362348|Secondary|Number of Participants With Vital Sign Data of Potential Clinical Concern|Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was <85 and >160 millimeters of mercury, diastolic blood pressure <45 and > 100 millimeters of mercury, heart rate <40 and >110 beats per minute. Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for systolic blood pressure, diastolic blood pressure and heart rate until Day 102.|Up to Follow-up (Day 102)|Safety Population|||Participants|||Count of Participants
1389475|NCT01362348|Secondary|Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination|A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), Intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 102.|Up to Follow-up (Day 102)|Safety Population.|||Participants|||Count of Participants
1389476|NCT01362348|Secondary|Number of Participants With Ocular Adverse Events (AEs), Non-ocular AEs, Serious Ocular AEs and Serious Non-ocular AEs|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Until Follow-up (Day 102)|Safety Population.|||Participants|||Count of Participants
1389477|NCT01362348|Secondary|Number of Participants Who Received Rescue Medication|At any time during the study, including the follow-up period, rescue treatment (standard of care) was given based on the clinical judgment of the investigator. Rescue treatment was to be strongly considered for participants whose center subfield thickness had increased by >50 microns from the lowest value on study or whose BCVA decreased by more than 5 letters compared to baseline and who also had persistent fluid by OCT. Data has been reported for the number of participants with their percentages who required any rescue medication administration until follow-up.|Up to follow-up (Day 102)|Safety Population comprised of any participant who received at least one dose of study medication.|||Participants|||Count of Participants
1389478|NCT01362348|Secondary|Number of Participants With Change in Charactertsics (Atrophy, Pigment, SR Hemorrhage, IR Hemorrhage, SR Fluid and Fibrosis) as Measured by FP|Fundus photography involves capturing of images of the center of the very back inner wall of the eye — the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme SR hemorrhage (absence or presence at the location), heme IR hemorrhage (absence or presence at the location), SR fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment (absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.|Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||Participants|||Count of Participants
1389479|NCT01362348|Secondary|Change From Baseline in the Area of Choroidal Neovascular (CNV) Size and CNV Total Lesion Complex Size as Measured by Fluorescein Angiography (FA) at Day 29|CNV was the measurement of the combined classic and occult neovascular lesion including areas of classic neovascularization, late staining of undetermined origin and fibrovascular PED. CNV total lesion complex size was the measurement of the entire lesion including classic and occult neovascular components as well as contagious blood and/or blocked fluorescence and/or serous PED. FA uses fundus photography (FP) to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling/circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. A fluorescein angiogram was obtained at Day 29. Images were evaluated by investigator for eligibility and by a central reading center for determination of PD effect. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||millimeter square||Standard Deviation|Mean
1389480|NCT01362348|Secondary|Change From Baseline in BCVA Over Time|BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.|||Letters||Standard Deviation|Mean
1389490|NCT01362322|Secondary|Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies|Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1389481|NCT01362348|Secondary|Change From Baseline in Intraretinal (IR) or Subretinal (SR) Fluid Thickness, Intraretinal Cysts or Serous Retinal Pigment Epithelial Detachment (PED Thickness) Over Time|OCT was used for the determination of retinal morphology changes in the study eye which included assessments of SR fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and PED (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.|||Microns||Standard Deviation|Mean
1389482|NCT01362348|Secondary|Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time|CRLT was the manual measurement of the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris, inclusive of subretinal or sub-retinal pigment epithelium fluid collections and of the thickness of any observable choroidal neovascular membrane or scar tissue, evaluated in the central 1 mm of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.|||Microns||Standard Deviation|Mean
1389483|NCT01362348|Primary|Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29|BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||Count of letters||Standard Deviation|Mean
1389484|NCT01362348|Primary|Change From Baseline in Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29|CRT was the distance between the inner limiting membrane of the retina and the inner border of the retinal pigment epithelium/choriocapillaris band, inclusive of sub retinal fluid, measured in the central 1 millimeter (mm) of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Images were evaluated by investigator for safety monitoring, and by a central reading center for eligibility determination and pharmacodynamics (PD) effects. Observed case (OC) data set was used for analysis in this analysis dataset, a missing assessment at any scheduled time point was considered unevaluable, was not imputed and was not included in data analysis. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the baseline value from the individual post-randomization value at Day 29.|Baseline (Week 0) and Day 29|The Intent-to-treat (ITT) Population comprised of any participant who received at least one dose of study medication. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||Microns||Standard Deviation|Mean
1389485|NCT01362322|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 - Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
1389486|NCT01362322|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.|Within 4 days (Days 0-3) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.|||Participants|||Count of Participants
1389487|NCT01362322|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) post|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
1389488|NCT01362322|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|Within 4 days (Days 0-3) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.|||Participants|||Count of Participants
1389489|NCT01362322|Secondary|Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.|Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL); for initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1389491|NCT01362322|Secondary|Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)|A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).|At Day 0 (PRE) vaccine and at Month 1 (POST)|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1389492|NCT01362322|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).|At Day 0 (PRE) vaccine and at Month 1 (POST)|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1389493|NCT01362322|Secondary|Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).|At Day 0 (PRE) and at Month 1 (POST)|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1389494|NCT01362322|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Day 0|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1389495|NCT01362322|Primary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Day 0|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1389496|NCT01362322|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL)|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1389497|NCT01362322|Primary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1389498|NCT01362296|Secondary|GSK1120212 Plasma Pharmacokinetic (PK) Concentration|Blood samples for PK analysis of GSK1120212 were collected at the following time points: Cycle 1 (Study Day 15), Cycle 2 (Study Day 22), Cycle 3 (Study Day 43), and Cycle 4 (Study Day 64). Post-dose PK samples collected on Day 15 of Cycle 1 occurred at least 1 hour apart. Participants were instructed to withhold the dose of GSK1120212 until after blood for PK samples had been drawn. Pre-dose samples were taken 15 minutes or less prior to taking the next dose (i.e., trough).|Day 15 of Cycle 1: pre-dose; 0.5-2 hours, 2-4 hours, and 4-8 hours post-dose; Day 1 of Cycle 2, Cycle 3 and Cycle 4: pre-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1389499|NCT01362296|Secondary|Overall Survival (OS)|OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, OS was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (maximum of 22 months)|MITT Population|||Months||95% Confidence Interval|Median
1389500|NCT01362296|Secondary|Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase|DOR was assessed by the investigator for participants with CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 mm in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). DOR is defined as the time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause (maximum of 10.2 months)|MITT Population. Only participants who achieved a CR or PR were analyzed for duration of response.|||Weeks||95% Confidence Interval|Mean
1389501|NCT01362296|Secondary|Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From the date of the first dose of study treatment in the Crossover Phase until the first documented evidence of a CR or PR (maximum of 4 months)|Crossover Population|||Participants|||Number
1393545|NCT01324622|Primary|Sagittal Angle Success|Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph|12 months|Number of participants with radiographic data available at 12 month visit|||participants with ≤15° sagittal angle|||Number
1389502|NCT01362296|Secondary|Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From randomization until the first documented evidence of a CR or PR (maximum of 10.2 months)|MITT Population|||Participants|||Number
1389503|NCT01362296|Secondary|Change From Baseline in Heart Rate: Crossover Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1389504|NCT01362296|Secondary|Change From Baseline in Heart Rate: Randomized Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1389505|NCT01362296|Secondary|Change From Baseline in SBP and DBP: Crossover Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1389506|NCT01362296|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle thereafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1389507|NCT01362296|Secondary|Number of Participants With Any SAE or Non-serious AE: Crossover Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study treatment in the Crossover Phase until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 12 months)|Crossover Population|||Participants|||Number
1389508|NCT01362296|Secondary|Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From randomization until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 19 months)|Safety Population|||Participants|||Number
1389509|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, and myelocytes. Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1389510|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, myelocytes, neutrophil bands (%). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1389511|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1389512|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1389513|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1389514|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1389515|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase|Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3, or Grade 4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population: all participants who, at the point of disease progression during the Randomized Phase, elected to enter the crossover portion of the study. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1393961|NCT01319721|Secondary|Postoperative Conjunctival Inflammation|The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe).|One month||||eyes|Participants||Number
1389516|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G, G3, or G4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population: all participants (KRAS, BRAF, NRAS, and MEK1 mutation positive) that received at least one dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
1389517|NCT01362296|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator (INV)|PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. For participants (PAR) who did not have a documented date of PD or DT, PFS was censored at the date of the last adequate assessment. For PAR who received subsequent anti-cancer therapy prior to the date of documented PD or DT, PFS was censored at the date of the last adequate assessment prior to the initiation of therapy.|From randomization (RAN) until the earliest date of documented radiological disease progression (PD) or death (DT) due to any cause (maximum of 10.2 months)|Modified Intent-to-Treat (MITT) Population: all randomized participants with KRAS mutation-positive non-small cell lung cancer (NSCLC), whether or not treatment was administered|||Weeks||95% Confidence Interval|Median
1389518|NCT01362244|Secondary|Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing)|Blood samples were collected at Weeks 1, 5, 13, and 25 for anti-mepolizumab antibody testing.|Weeks 1, 5, 13, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Participants|||Number
1389519|NCT01362244|Secondary|PK/PD Model Derived Maximum Inhibition|Blood samples were collected for the assessment of Maximum Inhibition at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Percentage of inhibition||Standard Error|Least Squares Mean
1389520|NCT01362244|Secondary|PK/PD Model Derived Half Maximal Effective Drug Concentration (EC50)|Blood samples were collected for the assessment of PK/PD model derived EC50 at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-partcipant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Microgram per liter||Standard Error|Least Squares Mean
1389521|NCT01362244|Secondary|PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual|A residual is the difference between the observed and predicted values. Blood samples were collected for the assessment of PK/PD model derived CV(Baseline), CV(Emax), and residual at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated subjects). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Percentage of variation||Standard Error|Least Squares Mean
1389522|NCT01362244|Secondary|Pharmacokinetic/Pharmacodynamic (PK/PD) Model Derived Baseline|Blood samples were collected for the assessment of PK/PD model derived Baseline at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available blood eosinophil count data were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Giga units per liter||Standard Error|Least Squares Mean
1389523|NCT01362244|Secondary|Half-life (Alpha) and Half-life (Beta)|Half-life (Alpha) is the rate of decline in plasma concentrations due to the process of drug redistribution from the central to the peripheral compartment and half-life (Beta ) is the rate of decline due to the process of drug elimination due to metabolism. Blood samples were collected for the assessment of half-life (Alpha) and half-life (Beta) at Weeks 1, 2, 5, 9, 13, and 25. Half-life was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Days||Standard Error|Least Squares Mean
1393962|NCT01319721|Secondary|Eye Movement Amplitude (EMA)||One Year||||millimeter|Participants|Standard Deviation|Mean
1389524|NCT01362244|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|Blood samples were scheduled to be collected for the assessment of AUC(0-inf) at Weeks 1, 2, 5, 9, 13, and 25 AUC[0-inf] is derived from individual systemic clearance estimates using the expression AUC[0-inf] = Dose/CL. Hence all data are incorporated into the estimation of CL and by implication AUC[0-inf]. The actual time range over which pharmacokinetic data were collected was from time 0 to 336 days post first dose.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Microgram.day per milliliter||Standard Error|Least Squares Mean
1389525|NCT01362244|Secondary|Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS)|Blood samples were collected for the assessment of Cmax, Cav(0-inf), and Cmax SS at Weeks 1, 2, 5, 9, 13, and 25. These parameters were estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Micrograms per milliliter||Standard Error|Least Squares Mean
1389526|NCT01362244|Secondary|Steady-State Volume of Distribution|Steady-state volume of distribution is the blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected for the assessment of steady-state volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. Steady-state volume of distribution was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1389527|NCT01362244|Secondary|Bodyweight-adjusted Clearance|Clearance is the volume of plasma that would contain the amount of drug excreted per day. Blood samples were collected for the assessment of bodyweight-adjusted clearance at Weeks 1, 2, 5, 9, 13, and 25. Clearance was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Liters per day||Standard Error|Least Squares Mean
1389528|NCT01362244|Secondary|Volume of Distribution at Weeks 1, 2, 5, 9, 13, and 25|Volume of distribution at steady-state was derived from pharmacokinetic parameter estimates of a population pharmacokinetic model. Blood samples were collected for analysis of volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. All available concentrations at all available datapoints from all participants were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Deviation|Mean
1389529|NCT01362244|Secondary|Systemic Clearance at Weeks 1, 2, 5, 9, 13, and 25|Blood samples were collected for the assessment of systemic clearance at Weeks 1, 2, 5, 9, 13, and 25. Systemic Clearance (CL) is estimated using a population-Pharmacokinetic model incorporating all available data points from all subjects. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|Pharmacokinetic (PK) Population: participants in the Safety Population for whom at least one PK sample was obtained and analyzed.|||Liters per day||Standard Deviation|Mean
1389530|NCT01362244|Secondary|VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The second part of the questionnaire is a VAS question, requiring the participant to self rate his/her health score on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1389531|NCT01362244|Secondary|Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The first part contains descriptions of the following five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses to each of the five domains are measured on a 3-point scale (1-no problems, 2-some problems, and 3-severe problems). An index for the descriptive scores was derived using the general European weights, obtained for each of the countries in this study. Index scores were derived for each participant at each time point. ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1389532|NCT01362244|Secondary|Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline)|"SNOT-22 questionnaire is a modification of the SNOT-20 and contains the questions (ques) related to smell and nasal obstruction. Each ques is graded with a numerical score for each response (res); scores range from 0 for no symptoms to 5 for as bad as things could be. Scores for each of the ques is summed to derive the total score for that par. at that visit. If the par. did not complete any ques at a visit, then he/she were not to have any missing values imputed, and his/her total score for that visit was set to missing. If a par. had some missing scores (but no more than 50% missing at that visit), then scores for the missing resp were imputed as the mean of the non-missing resp for that par. at that visit. The SNOT-22 total score ranges from 0 to 110, with higher scores representing a worse quality of life. Questionnaire data analysis was done using an ANCOVA to obtain the LS-means, treatment difference and confidence interval at Week 25, adjusting for Week 1 Baseline scores."|Week 1 and Week 25|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1389544|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|RBC count and RC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||10^12 cells per litre||Standard Deviation|Mean
1389533|NCT01362244|Secondary|Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Sniffin’Sticks were used to assess each participant’s sense of smell (olfaction). Olfaction testing results were recorded for both the right and left nostrils The worst nostril score (number of correct answers for the worst nostril) and the mean nostril score (mean number of correct answers across both nostrils) were recorded. Scores range from 0 to 12 (high score indicating normal olfactory sensation). Olfaction data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1389534|NCT01362244|Secondary|Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Participants used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken, and the largest measurement was recorded in the electronic diary. PNIF data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||L/min||95% Confidence Interval|Least Squares Mean
1389535|NCT01362244|Secondary|Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|"Participants were asked to indicate on a VAS (0 to 10 centimeters) the severity of four nasal polyposis symptoms (one VAS for each symptom): rhinorrhea; mucus in the throat; nasal blockage; loss of smell. The left-hand side of the scale (0) represents “not troublesome,” and the right hand side of the scale (10) represents “worst possible troublesome."|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Scores on a scale||Standard Deviation|Mean
1389536|NCT01362244|Secondary|Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PEFR is defined as the maximum airflow generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Liters/minute (L/min)||95% Confidence Interval|Least Squares Mean
1389537|NCT01362244|Secondary|Mean of Forced Vital Capacity (FVC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|FVC is defined as the maximum amount of air that can forcibly be blown out after a maximum inspiration. FVC was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1389538|NCT01362244|Secondary|Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. FEV1 measurements were taken by spirometry at each clinic visit. FEV1 was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 2, 5, 9, 13, 17, 21, and 25|ITT Population: all randomized participants who received at least one dose of study treatment. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Liters (L)||95% Confidence Interval|Least Squares Mean
1389539|NCT01362244|Secondary|Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|Up to Week 25|Safety Population|||Participants|||Number
1389540|NCT01362244|Secondary|Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks (Wk) 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Results for all urinalysis parameters were assessed for clinical relevance.|||participants|||Number
1389541|NCT01362244|Secondary|Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Reticulocyte count was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Fraction of 1||Standard Deviation|Mean
1389542|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCV was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Femtoliters||Standard Deviation|Mean
1389543|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCH was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Picograms (pg)||Standard Deviation|Mean
1389557|NCT01362205|Secondary|Resource Utilization Costs Associated With This Hospitalization Billed by Facility.||Up to 28 days|The overall number of participants analyzed is less than the number randomized as data was not available for research use at many of the participating institutions.|||USD||Inter-Quartile Range|Median
1389545|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Hemoglobin and MCHC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1389546|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Platelet count, WBC count, basophils, eosinophils, lymphocytes, monocytes, and neutrophils were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||10^9 cells per liter||Standard Deviation|Mean
1389547|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Total and direct bilirubin, creatinine, and uric acid were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Micromoles per liter||Standard Deviation|Mean
1389548|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Albumin and protein were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1389549|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ALT, AST, ALP, and GGT were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
1389550|NCT01362244|Secondary|Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|BUN, glucose fasting, chloride, sodium, potassium, carbon dioxide (CO2), and calcium were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1389551|NCT01362244|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were identified. ECG abnormaility with respect to CS and NCS findings were judged by the investigator or appropriately qualified designee.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Participants|||Number
1389552|NCT01362244|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25|Pulse rate was measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||beats per minute||Standard Deviation|Mean
1389553|NCT01362244|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 21, and 25|SBP and DBP were measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population: participants who received >=1 dose of study treatment (based on actual treatment received). A participant randomized to mepolizumab took placebo in error. Thus, “N” for the placebo arm of the SP is greater than for the ITT Population. Participants available at the specified time points (represented by n=X, X) were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1389554|NCT01362244|Secondary|Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Assessment of the nasal polyposis condition was performed after 6 months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a VAS. Surgery was required for participants with ENP scores of >=3, or ENP scores of 2 and a VAS symptom score of >7.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population|||Participants|||Number
1389555|NCT01362244|Secondary|Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Screening and Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Each nostril was assessed for polyps and graded at Screening and at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. The ENP score ranges from 0 (no polyps) to 4, with a higher score indicating a larger polyp. The ENP score was recorded for both the right and the left nostril. The higher of the two scores was derived and used for the analysis.|Screening; Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Participants|||Number
1389556|NCT01362244|Primary|Number of Participants With a Reduced Need for Surgery at the End of the Study (Week 25)|Assessment of the nasal polyposis condition was performed after six months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a visual analogue scale (VAS). Surgery was still deemed required for a participant with an ENP score of >=3, or an ENP score of 2 and a VAS symptom score of >7. The number of participants with reduced need for polyp surgery are presented as missing data set to non-responders (NR) and missing data last observation carry forward (LOCF). LOCF is defined as missing responses at Week 25 imputed with the last non-missing post-dose observation for that participant.|Week 25|Per Protocol Population: all randomized participants who received at least one dose of study treatment and who complied with the protocol.|||Participants|||Number
1389559|NCT01362205|Secondary|Scores at Hospital Discharge on the PTSD Civilian Checklist|PTSD checklist consists of 17 questions graded on a scale of 1 to 5. The PTSD score is comprised from the sum of the scores 17 questions. The PTSD score has possible values from to 17 to 85 with higher values indicating greater symptom severity.|Up to 28 days|The number of participants analyzed was lower than the total included as many patients were discharged quickly upon resolution of altered mental status when a research team member was unavailable to administer the questionnaires.|||units on a scale||Inter-Quartile Range|Median
1389560|NCT01362205|Secondary|Scores at Hospital Discharge on the Beck Anxiety Inventory|The Beck Anxiety Inventory is a validated questionnaire used to measure severity of anxiety (min score 0, max score 63). The higher the score the greater the severity of anxiety. A score of 30-63 indicates severe anxiety, 17-29 moderate anxiety, 10-16 mild anxiety and 0-9 minimal anxiety.|Up to 28 days.||||units on a scale||Standard Deviation|Mean
1389561|NCT01362205|Secondary|Scores at Hospital Discharge on the Beck Depression Inventory.|The Beck Depression Inventory is a validated questionnaire used to measure severity of depression (min score 0, max score 63). The higher the score the greater the severity of depression. A score of 30-63 indicates severe depression, 19-29 moderate depression, 10-18 mild depression and 0-9 minimal depression.|Up to 28 days.||||units on a scale||Standard Deviation|Mean
1389562|NCT01362205|Secondary|Scores at Hospital Discharge on the Mini Mental Exam.|The Mini Mental State Examination or Folstein test is a validated 30-point questionnaire used to measure cognitive impairment (min score 0, max score 30). A score of 24 points (out of a max of 30) indicates normal cognition, less than or equal to 9 points indicates severe impairment, 10-18 indicates moderate impairment and 19-23 mild impairment.|up to 28 days||||units on a scale||Standard Deviation|Mean
1389563|NCT01362205|Secondary|The Length in Days of the Hospital Stay|A hospital day is counted for any time on a calendar day the patient is admitted to the hospital. Hospital days are inclusive of ICU days.|up to 28 days||||days||Inter-Quartile Range|Median
1389564|NCT01362205|Secondary|Number of Ventilator Free Days After Randomization.|A ventilator day is counted for any use of invasive mechanical ventilation during a calendar day|up to 28 days||||days||Inter-Quartile Range|Median
1389565|NCT01362205|Secondary|The Number of CAM-ICU Negative Days After Randomization.|The Confusion Assessment Method (CAM)-ICU is a validated instrument used to detect the presence or absence of delirium in the ICU. A delirium free day is counted for any day a patient is negative by the CAM-ICU. The higher the number of CAM-ICU negative days indicates the more days a patient was able to think clearly.|up to 28 days||||days||Inter-Quartile Range|Median
1389566|NCT01362205|Secondary|Average MINDS Score|Minnesota Detoxification Scale (MINDS) min score 0, max score 46. The higher the score, the worse the symptoms of AWS/AWD.|up to 28 days||||units on a scale||Inter-Quartile Range|Median
1389567|NCT01362205|Primary|The Length of ICU Stay Defined as the Time Between Randomization and ICU Transfer Orders.||up to 28 days in hours||||hours||Inter-Quartile Range|Median
1389568|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|12 weeks (2nd laser treatment)|intent-to-treat|||Numeric Pain Rating Score||Standard Deviation|Mean
1389569|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment.|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|Day 0 (1st laser treatment)|intent-to-treat|||Numeric Pain Rating Score||Standard Deviation|Mean
1389570|NCT01362192|Secondary|Percent of Subjects Satisfied With Improvement of Treated Spider Veins.|"Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale:~1 = Very Much Not Satisfied~2 = Not Satisfied~3 = Somewhat Satisfied~4 = Satisfied~5 = Very Much Satisfied"|24 weeks (12 weeks post-final laser treatment)|per protocol|||percent of participants|||Number
1389571|NCT01362192|Secondary|"Percent of Subjects With Significant to Very Significant Improvement of Lower Extremity Spider Veins, as Assessed by Subject."|"Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol|||percent of participants|||Number
1389572|NCT01362192|Secondary|"Percent of Subjects With Significant or Very Significant Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator."|"The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol|||percent of participants|||Number
1389573|NCT01362192|Secondary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|12 weeks (post-1st laser treatment)|per protocol|||points on Improvement scale||95% Confidence Interval|Mean
1389574|NCT01362192|Primary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol|||points on Improvement scale||95% Confidence Interval|Mean
1390286|NCT01354132|Secondary|GPxbc Glutathione Peroxidase Activity in Blood Cells|GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells.|at 6 months||||umol/min/gHb||Standard Deviation|Mean
1389575|NCT01362140|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Fatigue|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~Clinically meaningful improvement in fatigue is defined as an increase of ≥ 3 points in the FACIT-Fatigue subscale score, from baseline to EOTP."|Baseline to week 24|FACIT-fatigue analysis set|||percentage of participants||95% Confidence Interval|Number
1389576|NCT01362140|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) Visual Analog Scale (VAS)|"The EQ-5D visual analog scale (VAS) is a global evaluation of overall health state with scores ranging from 0 (worse health state a participant can imagine) to 100 (best health state a participant can imagine).~End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|The EQ-5D visual analog analysis set includes all participants in the primary analysis set who completed both the baseline and at least 1 subsequent visual analog scale.|||units on a scale||Standard Deviation|Mean
1389577|NCT01362140|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement. End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|FACIT-Fatigue Analysis Set, includes all participants in the primary analysis set who completed or partially completed both the baseline and at least 1 subsequent FACIT-F questionnaire.|||units on a scale||Standard Deviation|Mean
1389578|NCT01362140|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa|"Two validated assays were used to detect the presence of anti-darbepoetin alfa antibodies.~Samples were first tested in an immunoassay to detect antibodies capable of binding to darbepoetin alfa. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against darbepoetin alfa. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~The number of participants who developed antibodies to darbepoetin alfa is defined as participants who were neutralizing antibody positive post-baseline with a negative or no result at baseline."|Baseline and end of double-blind treatment period (24 weeks)|Safety analysis set participants with post-baseline antibody results|||participants|||Number
1389579|NCT01362140|Secondary|Number of Participants With Malignancies Other Than AML, Basal Cell Carcinoma, or Squamous Cell Carcinoma of the Skin||Up to 24 weeks|Safety analysis set|||participants|||Number
1389580|NCT01362140|Secondary|Number of Participants With Disease Progression to Acute Myeloid Leukemia (AML)|Transformation to AML was assessed according to WHO guidelines in the absence of IP and any haematopoietic growth factors (2 weeks off dosing). Bone marrow and/or cytogenetic report confirmation of AML was required (marrow or peripheral blast cells ≥ 20%, presence of pathognomic AML cytogenetic change, or evidence of marrow blast criteria for erythroleukemia). A pathology report confirming other leukemias such as chloroma (granulocytic sarcoma, myeloid sarcoma) or leukemia cutis also constituted transformation to AML.|24 weeks|Safety analysis set with available data|||participants|||Number
1389581|NCT01362140|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading scale, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.~Prespecified adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer, included the following categories: hypersensitivity, cardiac failure, hypertension, malignancies, embolic and thrombolic events, venous thromboembolic events (VTEs), central nervous system vascular disorders, and ischemic heart disease."|From first dose of study drug until the end of the double-blind treatment period; 24 weeks.|Safety Analysis Set, including all participants who received at least 1 dose of study drug. One participant in the placebo arm inadvertently received a dose of darbepoetin alfa and is counted in the darbepoetin alfa group for safety analyses.|||participants|||Number
1389582|NCT01362140|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on International Working Group (IWG) 2006 Criteria in the Double-blind Treatment Period|"International Working Group 2006 erythroid response was defined as achieving an initial ≥ 1.5 g/dL increase in hemoglobin from baseline and sustaining an average rise of ≥ 1.5 g/dL in a rolling 56-consecutive day period in the absence of RBC transfusion.~Participants with no hemoglobin collected to the minimum time required to observe an IWG erythroid response (Week 13) were considered non-responders."|Up to 24 weeks|Primary analysis set participants with a central laboratory baseline hemoglobin value|||percentage of participants||95% Confidence Interval|Number
1389583|NCT01362140|Primary|Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period||Week 5 to Week 25|Transfusion Primary Analysis Set which includes all randomized and consented participants who received at least 1 dose of study drug and who had an end of treatment period (EOTP) visit ≥ day 29 (ie, start of week 5).|||percentage of participants|||Number
1389584|NCT01362062|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit|HAQ-DI is a self-completed patient questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The HAQ-DI is the sum of the scores from all domains and ranged from 0 (best) to 24 (worst). A negative change from baseline indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||units on scale||Standard Deviation|Mean
1390287|NCT01354132|Secondary|Blood Plasma Level of Cysteine|Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma.|at 6 months||||uM||Standard Deviation|Mean
1389585|NCT01362062|Secondary|Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit|The participant assessed their pain on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm, and is described as “unbearable pain”. A negative change indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||millimeters||Standard Deviation|Mean
1389586|NCT01362062|Secondary|Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as “maximum disease activity” (maximum arthritis disease activity).|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||millimeters||Standard Deviation|Mean
1389587|NCT01362062|Secondary|Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as “maximum disease activity” (maximum arthritis disease activity). A negative change from baseline indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||millimeters||Standard Deviation|Mean
1389588|NCT01362062|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1389589|NCT01362062|Secondary|Change From Baseline (CFB) in ESR Values at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||mm/hour||Standard Deviation|Mean
1389590|NCT01362062|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit|ACR20/ACR50/ACR70/ACR 90 response: greater than or equal to (≥) 20%/50%/70%/90% improvement in tender and swollen joint counts and 20%/50%/70%/90% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) Participant assessment of disease activity, 3) Participant assessment of pain (VAS), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) ESR at each visit.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 42), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
1389591|NCT01362062|Secondary|Time Taken to Achieve Remission (DAS28 <2.6 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment. Time taken to achieve remission is reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||days||Full Range|Mean
1389592|NCT01362062|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
1389593|NCT01362062|Secondary|Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity is defined as decrease in DAS28 to a value <3.2 Units at the time of assessment. Time taken to achieve low disease activity was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||days||Full Range|Mean
1389706|NCT01360840|Other Pre-specified|To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome||From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years|Data for this outcome measure was presented graphically as per planned analysis but not statistically summarized.||||||
1389594|NCT01362062|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low Disease Activity is defined as DAS28 value of <3.2 Units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
1389595|NCT01362062|Secondary|Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement. Time taken to achieve clinically meaningful improvement in DAS28 was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||days||Full Range|Mean
1389596|NCT01362062|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters [mm]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale [VAS]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*square root (√) of TJC + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population included participants who were observed prospectively in this study. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
1389597|NCT01362062|Primary|Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well as non-serious AEs.|Up to 12 months|Safety analysis population: Included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1389598|NCT01362049|Secondary|Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)|fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty|Baseline and 12 months|Participants with available data are included|||units on a scale||Standard Deviation|Median
1389599|NCT01362049|Secondary|Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)|fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
1389600|NCT01362049|Secondary|Change From Baseline in SF-36 Health Survey (0-100 Points)|Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state|Baseline and 12 months|Participants with available data are included|||units on a scale||Standard Deviation|Mean
1389601|NCT01362049|Secondary|Change From Baseline in SF-36 Health Survey (0 - 100 Points)|Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
1389602|NCT01362049|Primary|Change From Baseline in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved|Baseline and 12 months|Participants with available data are included|||units on a scale||Standard Deviation|Mean
1389603|NCT01362049|Primary|Change From Baseline in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
1389604|NCT01362049|Primary|Change From Baseline in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved|Baseline and 12 Months|Participants with available data are included|||units on a scale||Standard Deviation|Mean
1389605|NCT01362049|Primary|Change From Baseline in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
1389606|NCT01361867|Secondary|Step Height Adaptation|The percentage of the step height change caused by the mechanical perturbation that subjects compensate for|within a trial of the experiment (i.e. a few minutes)||||% step height compensated for||Standard Error|Mean
1389607|NCT01361867|Primary|Step Length Adaptation|The percentage of the step length change caused by the mechanical perturbation that subjects compensate for|within a trial of the experiment (i.e. a few minutes)||||% of step length compensated for||Standard Error|Mean
1393963|NCT01319721|Secondary|Healing Time of Corneal Epithelial Defect||Four Weeks||||days|Participants|Standard Deviation|Mean
1389617|NCT01361633|Primary|California Verbal Learning Test-II (CLVT-II)|The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. Software produces a report that computes raw and standardized scores. Our dependent variable was the age adjusted t-score for total number of words recalled after 5 trials. A higher score indicated better recall. The maximum possible score was 80 and a minimum was 0.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without patient follow up. Scores for the experimental and control group were compared.||||age adjusted t-scores||Standard Deviation|Mean
1389618|NCT01361620|Primary|Whole Blood Coagulation|Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.|Single measurement at 7-10 days after beginning aspirin||||Aspirin response units (ARU)||Standard Deviation|Mean
1389619|NCT01361607|Secondary|Change From Baseline In NRS Constipation At Last Visit (Up To Day 36)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was no constipation, and 10 was constipation as bad as you can imagine. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.~A negative value indicates improvement in condition from Baseline."|Baseline, Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1389620|NCT01361607|Secondary|Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment|"Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalence dose usages for each break-through opioid was calculated for the summary.~Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Baseline daily break-through opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1389621|NCT01361607|Secondary|Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of Treatment|"The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: “Have you used your maintenance dose painkiller today as prescribed?” If the participant answered “No” to the question, the daily opioid maintenance dose usage on that day was set to 0.~Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Baseline daily maintenance opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1389622|NCT01361607|Secondary|Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment|"The total daily opioid use (in morphine equivalence) was the sum of morphine equivalence of daily maintenance dose and break-through dose.~Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Baseline daily total opioid use.~A negative value indicates a decrease in use from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1389623|NCT01361607|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 36)|The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers “extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied”. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1389624|NCT01361607|Secondary|Physician Global Impression Of Change At Last Visit (Up To Day 36)|The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: “very much worse, much worse, slightly worse, no change, slightly improved, much improved, very much improved”. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1389625|NCT01361607|Secondary|Subject Global Impression Of Change At Last Visit (Up To Day 36)|The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse”. The SGIC was assessed at Day 36 or at which a participant’s last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.|Last visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1393964|NCT01319721|Secondary|Complications||One year||||eyes|Participants||Number
1389626|NCT01361607|Secondary|Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment|"Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated did not disrupt sleep and a score of 10 indicated completely disrupted (unable to sleep at all). Change in mean sleep disruption NRS was calculated as: End of Treatment sleep disruption NRS score - Baseline sleep disruption NRS score.~A negative value indicates an improvement in sleep disruption score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1389627|NCT01361607|Secondary|Change From Baseline In Mean NRS Worst Pain At End Of Treatment|"Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS worst pain was calculated as: End of Treatment NRS worst pain score - Baseline NRS worst pain score.~A negative value indicates an improvement in worst pain score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1389628|NCT01361607|Secondary|Change From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Baseline NRS average pain score.~A negative value indicates an improvement in average pain score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1389629|NCT01361607|Primary|Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was “no pain” and 10 was “pain as bad as you can imagine”. Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated).~Percentage improvement from baseline (Imp%) was calculated as:~Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean * 100.~For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew, unrelated to disease progression, before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||percent improvement||Inter-Quartile Range|Median
1389630|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit|within 3 months after discharge|||||||
1389631|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|Within 3 months after discharge|||||||
1389632|NCT01361594|Secondary|Surgical Wound Infection|Superficial and deep sternal wound infection|within 3 months after discharge|||||||
1389633|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).~Congestive heart failure~Cardiac arrhythmias: malignant arrhythmia"|within 3 months after discharge|||||||
1389634|NCT01361594|Secondary|Measures of Inflammation|Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers|average 1 month during the hospitalization|||||||
1389635|NCT01361594|Secondary|Incidence of Organ Failures Assessed by the Daily SOFA Score|Incidence of organ failures assessed by the daily SOFA score|average 1 month during the hospitalization|||||||
1389636|NCT01361594|Secondary|Number of Hospital Readmissions and Emergency Room Visits|Number of hospital readmissions and emergency room visits|Within 30 days after discharge|||||||
1389637|NCT01361594|Secondary|Thirty Day Mortality|Thirty day mortality|within 30 days of discharge|||||||
1389638|NCT01361594|Secondary|Duration of Ventilatory Support and ICU Readmission|Duration of ventilatory support and ICU readmission|average 1 month during the hospitalization|||||||
1389639|NCT01361594|Primary|Hospital Mortality|Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.|average 1 month during the hospitalization||||participants|||Number
1389640|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit.|average 1 month during the hospitalization|||||||
1389641|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|average 1 month during the hospitalization|||||||
1389642|NCT01361594|Secondary|Surgical Wound Infection|superficial and deep sternal wound infection|average 1 month during the hospitalization|||||||
1389643|NCT01361594|Secondary|ICU and Hospital Length of Stay, and ICU Readmissions|ICU and hospital length of stay, and ICU readmissions|average 1 month during the hospitalization|||||||
1389644|NCT01361594|Secondary|Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.|average 1 month during the hospitalization|||||||
1389645|NCT01361594|Secondary|Acute Renal Failure|new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline|average 1 month during the hospitalization|||||||
1389646|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).~Congestive heart failure~Cardiac arrhythmias: malignant arrhythmia"|average 1 month during the hospitalization|||||||
1389647|NCT01361594|Secondary|Glycemic Control|"Hyperglycemic events (BG > 200 mg/dL) in ICU and non-ICU~Hypoglycemic events (BG < 70 mg/dl; severe hypoglycemia (BG < 40 mg/dl)."|average 1 month during the hospitalization|||||||
1389648|NCT01361594|Primary|Number of Subjects That Were Diagnosed for Peri-operative Complications|Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization|Within 6 months of hospitalization||||participants|||Number
1389649|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Vomiting||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.|||percentage of patients|||Number
1389650|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Nausea||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.|||percentage of patients|||Number
1389651|NCT01361568|Secondary|Global Evaluation Responder Analysis|"Responders = Excellent or Very Good; Non-Responders = Fair or Poor. Patient who reported a score of Good were not included in the analysis as the midpoint cannot be unambiguously assigned for a binary outcome measurement."|At 24 hours|The responder analysis included all patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.|||Responder Count|||Number
1389652|NCT01361568|Secondary|Total Pain Relief Within the First 2 Hours (TOTPAR 0-2) Following Postoperative Study Drug Treatment Using LOCF|"Patients reported their pain relief using a 5-point categorical scale of 0 to 4 (0 = No Relief, 1 = A Little Relief, 2 = Some Relief, 3 = A Lot of Relief and 4 = Complete Relief). TOTPAR 0-2 was represents the cumulative time-weighted sum of the pain relief (PR) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 15 to 30 min, 30 to 45 min, etc.) over the first 2 hours. Pain relief assessments were measured at 15, 30, 45, 60, 90, 120 minutes after the start of the infusion of study drug following surgery.~Positive TOTPAR values represent an increase in pain relief."|0 to 2 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.|||units on a scale * hours||Standard Error|Mean
1389653|NCT01361568|Secondary|Morphine Consumption Following Postoperative Study Drug Treatment in the 2-24 Hour Period After Recovery in the Post-Anesthesia Care Unit (Post-PACU)||2 to 24 hours (post-PACU)|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion. Morphine consumption was calculated for the 2-24 hour period, after patients were transferred out of the PACU.|||mg||Standard Error|Mean
1389654|NCT01361568|Secondary|Summed Pain Intensity Difference From 0-24 Hours (SPID 0-24) Following Postoperative Study Drug Treatment Using Last Observation Carried Forward (LOCF)|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score), then at 15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, 720, 960, and 1440 minutes after the start of the infusion of study drug following surgery.~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.|||units on a scale * hours||Standard Error|Mean
1389655|NCT01361568|Primary|Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment||24 hours|The primary analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion.|||mg||Standard Error|Mean
1389656|NCT01361464|Secondary|Number of Participants With Relapse Free Survival|Relapse-free survival is calculated from the date of documentation of complete remission/morphologic complete remission with incomplete blood count recovery (CR/CRi) until disease relapse or death from any cause.|7 months|All evaluable participants|||participants|||Number
1389657|NCT01361464|Secondary|Median 1-Year Survival Rate|Prior to the early discontinuation of the study (for not meeting the primary endpoint of at least 3 CR/CRi after 2 cycles), investigators had planned to calculate one year survival from Kaplan Meier estimates.|1 year|Evaluable participants at planned study completion date||||||
1389658|NCT01361464|Secondary|Median Overall Survival (OS)|Overall survival is calculated from the first day of R115777 treatment and lasts until the date of death recorded on the case report form (CRF).|From first treatment through follow up period, an expected average of 12 months|All evaluable participants|||months||95% Confidence Interval|Median
1389679|NCT01361217|Primary|Lovastatin AUC in the Presence of Fluoxetine|Our primary outcome measure will be the interaction of fluoxetine with CYP3A4. A 50% increase in the AUC for lovastatin plus hydroxy-lovastatin acid (the active form of lovastatin) between treatment day 14 (study day 20) and control days (study day 2) is considered clinically significant.|The primary outcome will be assessed within 2 months after the last subject is enrolled or at 2 years from the start of study enrollment, which ever is sooner.||||nmol*hr/L||Standard Deviation|Mean
1389659|NCT01361464|Primary|Complete Remission (CR) Rate|Complete Remission (CR) rate in Acute Myelogenous Leukemia (AML) patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. AML Complete Remission: Bone marrow aspiration - Less than 5% leukemic blasts, Auer rods not detected; Peripheral blood counts - Absolute neutrophil count >/= 1,000/mm^3, Platelet count >/= 100,000/mm^3, Leukemic blasts not present; Blood-product transfusion independence; Absence of extramedullary leukemia.|From first treatment through follow up period, an expected average of 12 months|All evaluable participants|||percentage of participants|||Number
1389660|NCT01361308|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity score per day||Standard Deviation|Mean
1389661|NCT01361308|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Change from baseline BMI kg/m2||Full Range|Median
1389662|NCT01361308|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject’s total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
1389663|NCT01361308|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).~The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.~Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).~Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).~Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.~The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percentage of participants|||Number
1389664|NCT01361308|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject’s overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)~The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.~Responders: Subjects Achieving a Score of “Very Much Improved” Or “Much Improved” Or “Minimally Improved”.~Non Responders: Subjects with a Score of “No Change” Or “Minimally Worse” Or “Much Worse” Or “Very Much Worse”."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
1389665|NCT01361308|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
1389666|NCT01361308|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score|"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.~The sum of the scores for all 5 items was calculated at Week 4 and Week 12. The results presented below are change from baseline at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||units on a scale||Standard Deviation|Mean
1389667|NCT01361308|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject’s overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).~The measure being reported below is percentage of responders who had an improvement in NRSscore at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is defined as a score ≤5 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
1389668|NCT01361308|Secondary|Percentage of Patient Global Improvement (PGI) Scale Responders (%)|"Percentage of PGI Responders: Subject’s overall improvement in VMS from baseline assessed using the Patient Global Improvement (PGI) scale. Responders: Subjects Achieving a Score of “Very Much Better” Or “Much Better” Or “A Little Better”.~Non Responders: Subjects with a Score of “No Change” Or “A Little Worse” Or “Much Worse” Or “Very Much Worse”.~Patient Global Improvement (PGI) scale is described below:~Compared to before starting study medication, how would you describe your hot flushes now? 0 = Not assessed~= Very much better~= Much better~= A little better~= No change~= A little worse~= Much worse~= Very much worse"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
1389669|NCT01361308|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
1389670|NCT01361308|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||units on a scale||Full Range|Median
1389671|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
1389680|NCT01361178|Primary|The Primary Outcome Will be the Total Number of Days With Pneumonia.|The primary outcome for this study will be the total number of days with pneumonia. Pneumonia will be defined by the presence of both clinical and radiographic criteria: fever (temperature ≥ 38oC), cough, dyspnea, purulent expectoration and/or changes in the previous characteristics of respiratory secretions; and chest X-ray or CT scan revealing a new or progressive alveolar or interstitial infiltrate or cavitation that could not be explained by any other noninfectious cause.|Up to two years post-transplant||||Number of days|||Number
1389681|NCT01361126|Secondary|Breakthrough Bleeding Events|Number of breakthrough bleeding events (spontaneous bleeding events) requiring treatment per subject in subjects receiving prophylactic treatment regimen with rIX-FP|Week 9 to approximately Week 20|Per protocol population|||Events per subject||Standard Deviation|Mean
1389682|NCT01361126|Secondary|Clearance of a Single Dose of rIX-FP||Pre-dose and up to 14 days after rIX-FP infusion|PK population|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1389672|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
1389673|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
1389674|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
1389675|NCT01361308|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.~The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Nightime awakenings||Full Range|Median
1389676|NCT01361308|Secondary|Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%)|"A patient improvement scale questionnaire was used during participant visits.~The clinical meaningfulness of the observed treatment effect was demonstrated by performing the following analysis:~Subjects were categorized in to 2 groups (satisfied and unsatisfied). Based on a 7 point patient global impression (PGI) questionnaire which assesses the subject improvement in VMS. Subjects were considered satisfied with their treatment if their response to the question “Compared to before starting the study medication, how would you describe your hot flushes now?” is ‘Very much better’ (1) or ‘Much better’ (2) or ‘A little better’ (3) and will be considered unsatisfied if their response to the same question is ‘No change’ (4) or ‘A little worse’ (5) or ‘Much worse’ (6) or ‘Very much worse’ (7). Receiver Operator Curve (ROC) analysis was performed on the combined data.~Subjects who were satisfied with their treatment were considered to have a treatment effect with clinical meaningfulness"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percentage of satisfied participants|||Number
1389677|NCT01361308|Primary|Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.~The results reported are:~Mean Baseline frequency of moderate to severe VMS~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flash per day||Standard Deviation|Mean
1389678|NCT01361217|Secondary|AUC of Dextromethorphan, Midazolam and Omeprazole in the Presence of Fluoxetine|Our secondary outcome measure will be the interaction between fluoxetine and each CYP evaluated in the cocktail. A 50% increase in the AUC of caffeine (CYP1A2), dextromethorphan (CYP2D6), omeprazole (CYP2C19) or midazolam (CYP3A4) between treatment and control days is considered clinically significant. The interaction of fluoxetine with caffeine (CYP1A2) will be considered as a negative control for the study. These AUCs will be measured on study day 1 (control day) and study day 18|The secondary outcome will be assessed within 2 months after the last subject is enrolled or at 2 years from the start of study enrollment, which ever is sooner.||||nmol*hr/L||Standard Deviation|Mean
1389683|NCT01361126|Secondary|Incremental Recovery of rIX-FP at 30 Minutes Following Infusion of rIX-FP|Incremental recovery (IU/mL/IU/kg) is defined as FIX activity (IU/mL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method.|30 minutes after infusion|PK population|||IU/dL/IU/kg||Geometric Coefficient of Variation|Geometric Mean
1389685|NCT01361126|Secondary|Area Under the Curve to the Last Sample With Quantifiable Drug Concentration (AUC0-t) After a Single Dose of rIX-FP|The plasma concentrations of rIX-FP were measured as FIX activity using a validated, 1-stage assay in a central laboratory for a quantification range from 0.25 to 150% (or 0.25 IU/dL to 150 IU/dL). The PK population comprised all subjects who received at least 1 dose of rIX-FP and for whom a sufficient number of analyzable PK samples had been obtained in order to permit the evaluation of the PK profile of rIX-FP, and who did not receive a dose of rIX-FP or any other FIX product for the treatment of a bleed during the PK sampling period.|Pre-dose and up to 14 days after rIX-FP infusion.|PK population|||h*IU/dL||Geometric Coefficient of Variation|Geometric Mean
1389686|NCT01361126|Primary|Number of Subjects Who Developed Antibodies to rIX-FP|Antibodies against rIX-FP were detected using a direct binding enzyme-linked immunosorbent assay (ELISA).|Pre-dose, Day 10 and Weeks 4, 12, and 20|Safety Population|||participants|||Number
1389687|NCT01361126|Primary|Number of Subjects With Inhibitors Against Factor IX (FIX)|The presence of inhibitors against FIX was assessed by the central laboratory by a FIX potency assay. To quantify anti-FIX neutralizing antibodies, the Bethesda assay with the Nijmegen modification was used, and the results expressed as Bethesda Units per mL (BU/mL). A positive inhibitor test is >=0.6 BU/mL.|Baseline, Day 10 and Weeks 4, 12 and 20|Safety Population|||participants|||Number
1389688|NCT01361126|Primary|Number of Subjects With Treatment-related Adverse Events|The causal relationship of each adverse event to rIX-FP was assessed by the Investigator.|Approximately 20 weeks|Safety Population|||participants|||Number
1389689|NCT01361113|Secondary|Number of Participants With Adverse Events Related to Treatment.|"Identify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy. Number of patients that had adverse events reported that had an attribution of; possible, probable, or definite that are graded a 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE v4.0).~Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event."|9 weeks||||Participants|||Count of Participants
1389690|NCT01361113|Secondary|Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib|Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response.|14 weeks||||Participants|||Count of Participants
1389691|NCT01361113|Secondary|Recurrence Free Survival (RFS)|Estimate recurrence free survival (RFS) following neoadjuvant treatment with pazopanib followed by nephrectomy, specifically reporting the 1 year and 2 year rate estimates with their 95% confidence intervals.|2 years||||percentage of Participants||95% Confidence Interval|Number
1389692|NCT01361113|Primary|Response Rate|"Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma.~Evaluation of Target Lesions using RECIST 1.1 Criteria:~Complete response (CR)−Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to <10mm.~Partial response (PR)−At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD."|8 weeks after neoadjuvant treatment||||Participants|||Count of Participants
1389693|NCT01361048|Secondary|Tolerability of the Study Product as Measured by Participant Self-report|Number of participants with any side effects|day 12-15 day 30-35||||Participants|||Count of Participants
1389694|NCT01361048|Primary|Percentage of Participants Cured of Vaginal Trichmonas|percentage of participants achieving microbiological cure of trichomonas|day 12-15||||percentage of participants|||Number
1389695|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at the End of Study|At the end of study, the distribution of patients in 3 pramipexole dosage categories.|12 weeks|There were 2017 patients in SAS set|||percentage of patients|||Number
1389696|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at Baseline|At enrollment, the distribution of patients in 3 pramipexole dosage categories.|baseline|There were 2017 patients in SAS set.|||percentage of patients|||Number
1389697|NCT01361009|Secondary|Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)|Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).|Baseline (Visit 1) and 12 weeks (Visit 3)|There were 1891 patients in full analysis set(FAS). FAS includes all patients who fulfilled the inclusion criteria and exclusion criteria, without missing PGI values at visit 1 and visit 3. In the recruited 2017 patients, 116 patients didn't fully meet the inclusion or exclusion criteria and 10 patients missed PGI data at visit 1 or visit 3.|||unit on a scale||Standard Deviation|Mean
1389698|NCT01361009|Primary|Incidence of AE/SAE|The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.|12 weeks|There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment.|||Percentage of participants|||Number
1389699|NCT01360996|Secondary|Oral Disposition Index|Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism|24 weeks||||calculated index||Standard Deviation|Mean
1389700|NCT01360996|Secondary|Adrenal Androgen DHEAS|Post-treatment levels of adrenal androgen DHEAS|24 weeks||||micromol/L||Standard Deviation|Mean
1389701|NCT01360996|Secondary|Menstrual Cycle Regularity|Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..|24 weeks||||number of cycles annually||Standard Deviation|Mean
1389702|NCT01360996|Secondary|Biochemical Indicator of B-vitamin Status|Post-treatment in folate concentrations after 24 weeks of treatment|24 weeks||||Folate in nmol/l||Standard Deviation|Mean
1389703|NCT01360996|Secondary|Post Therapy BMI.|Post-treatment body mass index at 24 weeks|24 weeks||||kg/m2||Standard Deviation|Mean
1389704|NCT01360996|Secondary|Cardiometabolic Measures|Values represent blood pressure at 24 weeks.|24 weeks||||mmHg||Standard Deviation|Mean
1389707|NCT01360840|Secondary|Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion|The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"PKA included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."|||liter||Standard Deviation|Mean
1389708|NCT01360840|Secondary|Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)|The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"Pharmacokinetic Analysis Set (PKA) included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."|||Liter per hour||Standard Deviation|Mean
1389709|NCT01360840|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.|From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years|The Safety analysis set included all the randomized subjects who received at least 1 dose of planned trial treatment and had at least one safety assessment following the trial treatment.|||Subjects|||Number
1389710|NCT01360840|Secondary|Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)||Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
1389711|NCT01360840|Secondary|Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)||Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
1389712|NCT01360840|Secondary|Minimum Percentage Change From Baseline in PSA Serum Concentration||Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
1389713|NCT01360840|Secondary|Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response|PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Subjects|||Number
1389714|NCT01360840|Secondary|Number of Subjects With Presence of Skeletal Related Events|Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||Subjects|||Number
1389715|NCT01360840|Secondary|Bone and Soft Tissue Lesions Composite Tumor Response|Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||Subjects|||Number
1389716|NCT01360840|Secondary|Number of Subjects With Presence of DC in Bone Lesions|Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.|At Weeks 13, 19 and 25|ITT analysis set included all the subjects randomized in the study.|||Subjects|||Number
1389717|NCT01360840|Secondary|Number of Subjects With New Bone Lesions Compared to Baseline|New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Subjects|||Number
1389727|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
1389718|NCT01360840|Secondary|Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions|Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|"ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure."|||Subjects|||Number
1389719|NCT01360840|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator’s discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||months||95% Confidence Interval|Median
1389720|NCT01360840|Secondary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||months||95% Confidence Interval|Median
1389721|NCT01360840|Primary|Progression Free Survival (PFS) Time|PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator’s discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|Intention-to-treat (ITT) analysis set included all the subjects who were randomized in the study.|||months||95% Confidence Interval|Median
1389722|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
1389723|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
1389724|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
1389725|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
1389726|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
1389898|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
1389728|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-A Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Error|Least Squares Mean
1389729|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Anxiety (HAM-A) Rating Scale Total Score for the Efficacy Sample|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Error|Least Squares Mean
1389730|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-D Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.|||Units on a scale||Standard Error|Least Squares Mean
1389731|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Depression (HAM-D) Rating Scale Total Score for the Efficacy Sample.|The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms.|Baseline and Week 14|Efficacy Sample comprised all participants in Safety Sample who had end of Phase A value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The Last-observation-carried-forward (LOCF) data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.|||Units on a scale||Standard Error|Least Squares Mean
1389732|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Per the Final Protocol.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389733|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389734|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the IDS-SR Total Score for the Efficacy Sample Per the Final Protocol.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.~The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389735|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score for the Efficacy Sample.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.~The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389736|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in CGI-S Scale Score for the Efficacy Sample Per the Final Protocol.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389737|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score for the Efficacy Sample.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389738|NCT01360645|Secondary|Mean CGI-I Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample Per the Final Protocol.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Deviation|Mean
1389739|NCT01360645|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Deviation|Mean
1389740|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389741|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389742|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in SDS Score for the Efficacy Sample Per the Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1390312|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||beats per minute (bpm)||Standard Deviation|Mean
1389743|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in Sheehan Disability Scale (SDS) Score for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389744|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389745|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389746|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks, 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Percentage of participants|||Number
1389747|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Percentage of participants|||Number
1389748|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol|MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13 and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Percentage of participants|||Number
1389749|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set|MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Percentage of participants|||Number
1389750|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Percentage of participants|||Number
1389751|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Percentage of participants|||Number
1389752|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Deviation|Mean
1389753|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set|"The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment.~Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse."|Week 8 to Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Deviation|Mean
1389754|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher score indicating worse anxiety symptoms.|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389755|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set|The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the “best” rating and 4 is the “worst” rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389756|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52, with higher score indicating more severe depression.|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389757|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52, with higher scores indicating more severe depression.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389764|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389758|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol|The IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDSSR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389759|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) IDS-SR Total Score for the Efficacy Sample Set|IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms and atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDS-SR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place.|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389760|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389761|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Weeks 8, 9, 10, 11, 12,13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389762|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389763|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set|The SDS is a self-rated instrument used to measure the effect of the patient’s symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389772|NCT01360554|Secondary|Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
1389765|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389766|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Week 8, 9, 10, 11, 12, and 13|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389767|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Week 8, 9, 10, 11, 12, and 13|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389768|NCT01360632|Primary|Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline and Week 14|Analysis was based on all participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
1389769|NCT01360632|Primary|Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set|The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
1389770|NCT01360554|Secondary|Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score|The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting “no health problems,” “moderate health problems,” and “extreme health problems.” The EQ VAS records the respondent’s self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
1389771|NCT01360554|Secondary|Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.|The QLQ-LC13 included questions specific to the disease associated symptoms (dyspnea, cough, haemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy, and alopecia), and analgesic use of lung cancer patients. Scores range from 0-100 and a higher score indicates greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
1404850|NCT01222104|Secondary|Rate of Major Vascular Complications (MVCs) by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).|30 days||||% of procedures with MVCs|Participants||Number
1389773|NCT01360554|Secondary|Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a better level of quality of life. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
1389774|NCT01360554|Secondary|Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.|TTD defined as the time from first dose (baseline) to the first time a patient's score in pain, dyspnea, fatigue or cough from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-LC13) increased by ≥10 points. A ≥10 point increase in score had to be maintained for ≥2 consecutive cycles for the symptom to be considered deteriorated. Participants were censored at the last time when they completed an assessment for pain, dyspnea, fatigue or cough if they had not deteriorated. A 10 point or higher change in the score is perceived by participants as clinically significant.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Months||95% Confidence Interval|Median
1389775|NCT01360554|Secondary|Trough Concentrations (Ctrough) of PF-05199265.|Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.|Baseline up to Cycle 5 Day 1|Participants treated with dacomitinib with at least one measured plasma concentration.|||Trough Plasma Concentration (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1389776|NCT01360554|Secondary|Trough Concentrations (Ctrough) of Dacomitinib.|Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.|Baseline up to Cycle 5 Day 1|Participants treated with dacomitinib with at least one measured plasma concentration.|||Trough Plasma Concentration (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1389777|NCT01360554|Secondary|DR Based on Investigator Review.|DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.|||Months||95% Confidence Interval|Median
1389778|NCT01360554|Secondary|Duration of Response (DR) Based on Independent Radiologic Review.|DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.|||Months||95% Confidence Interval|Median
1389779|NCT01360554|Secondary|BOR Per Investigator Review.|The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Participants|||Number
1389799|NCT01359943|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|"The patient’s global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question Considering all the ways rheumatoid arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are doing today”. A negative change from baseline indicates improvement."|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1389899|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
1389780|NCT01360554|Secondary|Best Overall Response (BOR) Per Independent Radiologic Review.|The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Participants|||Number
1389781|NCT01360554|Secondary|OS in KRAS-WT Participants.|OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1389782|NCT01360554|Secondary|Overall Survival (OS).|OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).|From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1389783|NCT01360554|Secondary|PFS Based on Investigator Review in KRAS-WT Participants.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1389784|NCT01360554|Secondary|PFS Based on Investigator Review.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1389785|NCT01360554|Primary|Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1389843|NCT01359371|Secondary|Determine if There Were Differences in Quit Rates Between Those That do and do Not Participate in the Peer Telephone Cessation Counseling.||7-day point prevalence quit rate on 60-day survey|||||||
1394116|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1389786|NCT01360554|Primary|Progression-Free Survival (PFS) Per Independent Radiologic Review.|PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
1389787|NCT01360450|Secondary|Cumulative Dose of Opioid and Benzodiazepine|We will determine the total amount of opioid and benzodiazepine needed from the start of detoxification to the end of the the detoxification.|2-4 weeks|No data is available for this outcome measure, as it was not collected.||||||
1389788|NCT01360450|Secondary|Cardiovascular Side-effects Changes HR and BP|Changes in Heart Rate (HR) and BP for 48 hrs after starting study drug and for 48hrs after stopping study drug|48 hrs after starting study drug and for 48hrs after stopping study drug|No data is available for this outcome measure, as it was not collected.||||||
1389789|NCT01360450|Primary|Time to Complete Detoxification|Time to complete detoxification is defined as 48 hrs off all opioids/benzodiazepines and study drug with acceptable withdrawal scores of <9 (on average we expect the infant to be enrolled in the study for 2-4 weeks). The scale used to assess withdrawal was the Modified Finnegan Neonatal Withdrawal Scale, which ranges from 0-41, 0 represents no withdrawal and 41 represent maximum withdrawal.|up to 4 weeks||||days||Standard Deviation|Mean
1389790|NCT01360021|Secondary|Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)|Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.|Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Inhalations/24 hrs||Standard Deviation|Mean
1389791|NCT01360021|Secondary|Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)|The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.|Recorded 6:00 – 11:00 AM for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Percentage of days with no awakenings||Standard Deviation|Mean
1389792|NCT01360021|Secondary|Asthma Symptoms Score (Total)|The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.|Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Asthma score on a scale of 0 to 3||Standard Deviation|Mean
1389793|NCT01360021|Secondary|Peak Expiratory Flow||Recorded morning upon rising and evening before sleep for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||L/Min||Standard Deviation|Mean
1389794|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose|Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Liters||Geometric Coefficient of Variation|Geometric Mean
1389795|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Post Dose|Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Liter||Geometric Coefficient of Variation|Geometric Mean
1389796|NCT01359943|Secondary|Change From Baseline in ESR|Blood for this assessment was obtained to monitor disease activity and response to therapy. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||mm/hr||Standard Error|Least Squares Mean
1389797|NCT01359943|Secondary|Change From Baseline in hsCRP|Blood for this assessment was obtained to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||mg/L||Standard Error|Least Squares Mean
1389798|NCT01359943|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|The physician’s global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question “Considering all the ways rheumatoid arthritis affects your patient, how would you rate his or her current condition?”. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1389800|NCT01359943|Secondary|Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain|The patient’s assessment of pain was performed using 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (unbearable pain) after the question “Please indicate with a vertical mark through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours”. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1389801|NCT01359943|Secondary|Change From Baseline in Tender 68-joint Count|The 68 joints assessed for tenderness included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Number of joints||Standard Error|Least Squares Mean
1389802|NCT01359943|Secondary|Change From Baseline in Swollen 66-joint Count|The 66 joints assessed for swelling included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). A negative change in baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Number of joints||Standard Error|Least Squares Mean
1389803|NCT01359943|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response criteria are based on DAS28 status in combination with DAS28 improvements. The EULAR response criteria are as follows: present DAS28 <3.2 with DAS28 improvement >1.2 corresponds to 'good response'; present DAS28 <3.2 with DAS28 improvement between 0.6 to 1.2, or present DAS28 between 3.2 to 5.1 with DAS28 improvement from 0.6 to >1.2, or present DAS28 >5.2 with DAS28 improvement >1.2 correspond to 'moderate response; present DAS28 <3.2 with DAS28 improvement <0.6, or present DAS28 between 3.2 to 5.1 with DAS28 improvement <0.6, or present DAS28 >5.1 with DAS28 improvement <0.6 to 1.2 correspond to 'no response'.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Percentage of participants|||Number
1389804|NCT01359943|Secondary|Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), erythrocyte sedimentation rate (ESR), and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-ESR is calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The calculation results in a DAS28-ESR score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1389805|NCT01359943|Secondary|Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28-CRP is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-CRP is calculated using the following formula: DAS28-4(crp) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28-CRP score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1389806|NCT01359943|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.|The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.|baseline, 12 Weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1389807|NCT01359943|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Percentage of participants|||Number
1404851|NCT01222104|Secondary|Impact of Guided Access on Achieving Target Puncture Location.|The influence of fluoroscopy and/or ultrasound guided access on puncture location.|30 days|Deployed subjects with readable angiograms|||% within target zone|||Number
1389808|NCT01359943|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Percentage of participants|||Number
1389809|NCT01359904|Secondary|the Number of Infections Related to Vascular Access in Dialysis Among Those Who Receive a Higher Glucose Concentration in the Dialysate and Those Who Receive the Standard Concentration|In the two groups, we will measure the number of episodes of vascular access related infections ie. catheter, AV fistula or AV graft associated infections in the study period. The episode was defined as a diagnosis in the chart written by the nurse or physician with a prescription of antibiotics.|3 months||||episodes|||Number
1389810|NCT01359904|Secondary|To Record the Effects of a Higher Dialysate Concentration of Glucose on Glycemic Control of Hemodialysis Patients With Type 2 Diabetes Mellitus by Measuring Serum Levels of Hemoglobin A1c.|Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value. The blood samples were taken prior to dialysis treatments mid-week for each subject at baseline and at the end of the study in both the control and intervention groups.|3 months||||percent||Full Range|Median
1389811|NCT01359904|Primary|Hemoglobin A1c Levels|post intervention hemoglobin A1c levels|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.|||percent||Full Range|Median
1389812|NCT01359904|Secondary|Episodes of Hypoglycemia|record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.|||episodes|||Number
1389813|NCT01359748|Primary|BP Measurement Using Multifunction KEITO|"Prior starting the measurement phase using Multifunction KEITO, the under test device was reset before each new measurement.~The subject has to be at rest at least 60 seconds before be measured."|30 seconds||||mmHg||Standard Deviation|Mean
1389814|NCT01359748|Primary|BP Measurements Using the Reference Auscultatory Sphygmomanometer|"The subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope.~The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures."|Five minutes||||mmHg||Standard Deviation|Mean
1389815|NCT01359735|Secondary|Subject Reported Signs and Symptoms|Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged.|At each evaluation visit: Weeks 3, and 12 post-surgery.|The ITT population – all subjects who underwent MMS. Both the total score and individual item score of the two signs and symptoms rating scales were summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test, and the P-value of a 1-sided test was reported.|||units on a scale||Standard Deviation|Mean
1389816|NCT01359735|Secondary|Investigator Reported Signs and Symptoms|Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged.|At each evaluation visit: Weeks 3 and 12 post-surgery.|The ITT population–all subjects who underwent MMS. Both total score and individual item score of the two signs and symptoms rating scales summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test. the P-value of a 1-sided test was reported.|||units on a scale||Standard Deviation|Mean
1389817|NCT01359735|Secondary|Time in Days to Wound Closure|The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.|Over the 12 week treatment period|The ITT population – all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference.|||Days||Standard Deviation|Mean
1389818|NCT01359735|Secondary|The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.|Complete wound closure was assessed at each evaluation visit.|Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks|The ITT population – all subjects who underwent MMS. Fisher’s exact test was used to examine the difference in proportion of subjects with complete wound closure at each of the corresponding time points between the two treatment groups, and the P-value of a 1-sided test was reported.|||participants|||Number
1389819|NCT01359735|Primary|The Primary Efficacy Measure Was the Investigator’s Global Assessment of Healing (IGAH).|The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.|13 weeks- The IGAH was measured at study Weeks 4 and 13|The ITT population – all subjects who underwent MMS.|||units on a scale||Standard Deviation|Mean
1389844|NCT01359371|Primary|Determine Differences in the Demographics, Health Characteristics, and Smoking Characteristics of Those Who Were Reached 3-4 Times and Those Who Were Reached 0-2 Times for Peer Telephone Counseling.|Bivariate relationships between number of times a veteran was reached by the volunteer and smoking outcomes as well as other covariates were calculated, using Wald chi-square tests for differences in proportions.|60-day survey - one survey, completed 60 days after discharge|At 60-days after in-patient discharge, seven-day point-prevalence quit rates were higher for those reached 3-4 times.|||participants|||Number
1389845|NCT01359254|Secondary|Survival at Day 100|Percent of subjects who are alive 100 days after the stem cell infusion|100 days|The only enrolled patient failed to complete the study due to death.||||||
1389820|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe|AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)|All participants who received at least 1 dose of study drug and entered follow-up period|||Participants|||Number
1389821|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.|First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)|All participants who received at least 1 dose of study drug.|||Participants|||Number
1389822|NCT01359644|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24|Change from baseline in log10 HCV RNA at scheduled sampling time.|Baseline, Follow-up week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||IU/mL||Standard Deviation|Mean
1389823|NCT01359644|Secondary|Percentage of Participants Who Experienced Viral Relapse During Follow-up Period|Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.|Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1389824|NCT01359644|Secondary|Percentage of Participants With Viral Breakthrough During the Treatment Period|Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.|First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1389825|NCT01359644|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as participant’s hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here the ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1389826|NCT01359644|Primary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1389827|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination|Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population|||Participants|||Number
1389828|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.~Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population|||Participants|||Number
1389846|NCT01359254|Primary|Cord Blood Engraftment by Day 100|"Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.~As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient."|100 days|The only enrolled patient failed to complete the study due to death.||||||
1389900|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
1389829|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.~Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population|||Participants|||Number
1389830|NCT01359449|Secondary|Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)|Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers < 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate|28 days post-vaccination|Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group|||Participants|||Number
1389831|NCT01359449|Secondary|Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.|Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group|28 days post-vaccination|Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.|||Titers||95% Confidence Interval|Geometric Mean
1389832|NCT01359449|Secondary|Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population|||Participants|||Number
1389833|NCT01359449|Secondary|Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1389834|NCT01359449|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population|||Participants|||Number
1389835|NCT01359449|Primary|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population|||Titers||95% Confidence Interval|Geometric Mean
1389836|NCT01359410|Post-Hoc|Intraoperative Complications Incurred by Participants||100 days or removal of drain||||intraoperative complications|||Number
1389837|NCT01359410|Secondary|Number of Non-pancreatic Adverse Events||100 days or removal of drain||||non-pancreatic adverse events|||Number
1389838|NCT01359410|Secondary|Time to Drain Removal||100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.|||days||95% Confidence Interval|Median
1389839|NCT01359410|Secondary|Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System||100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.|||Participants|||Count of Participants
1389840|NCT01359410|Primary|Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System|"Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way~Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure~Grade B: >3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula~Grade C: >3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula"|100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.|||Participants|||Count of Participants
1389841|NCT01359371|Secondary|Estimate the Costs of Implementing the Volunteer Peer Telephone Counseling Including Cost Per Patient and Cost Per Quit.||Collect cost of labor data and number of hours spent by the volunteers providing peer telephone counseling.|||||||
1389842|NCT01359371|Secondary|Evaluate Satisfaction With Program, Barriers and Facilitators to Implementation and Participating in the Program, and Quality of the Counseling||Interviews with patients, volunteers, and staff; observing volunteer phone calls|||||||
1389847|NCT01359150|Secondary|Geometric Mean Titer (GMT) of Anti-Influenza Antibody|Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
1389848|NCT01359150|Secondary|Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody|Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.|||microgram/milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1389849|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)|GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||fold rise||95% Confidence Interval|Geometric Mean
1389850|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)|Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||fold rise||95% Confidence Interval|Geometric Mean
1389851|NCT01359150|Secondary|Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine|Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of >= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
1389852|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 3 Influenza Antigens|Response to the influenza vaccine (seroconversion) was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
1389853|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens|Response to the pneumococcal vaccine (seroconversion) was defined as >= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
1389854|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the influenza vaccine was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
1389855|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (End of Study [EOS])|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
1389856|NCT01359111|Secondary|Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.|The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day||||percentage of injections|Participants||Number
1389857|NCT01359111|Secondary|Proportion of Participants With Safety Events|The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|2 days||||percentage of participants|||Number
1389858|NCT01359111|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day||||percentage of injections|Participants||Number
1389859|NCT01359007|Secondary|Number of Participants Who Experienced Toxicity||2 years||||Participants|||Count of Participants
1389860|NCT01359007|Secondary|Overall Survival||2 years|Data was not collected from any single study participant.||||||
1389861|NCT01359007|Secondary|Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)||2 years|Data was not collected from any single study participant.||||||
1389862|NCT01359007|Secondary|Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.||2 years|Data was not collected from any single study participant||||||
1389863|NCT01359007|Primary|To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.||2 years|Data was not collected from any single study participant.||||||
1389864|NCT01358877|Secondary|Cmax of Trastuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||mcg/mL||Standard Deviation|Mean
1389865|NCT01358877|Secondary|Peak Serum Concentration (Cmax) of Pertuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||mcg/mL||Standard Deviation|Mean
1389866|NCT01358877|Secondary|Cmin of Trastuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||mcg/mL||Standard Deviation|Mean
1389867|NCT01358877|Secondary|Trough Serum Concentration (Cmin) of Pertuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|Pharmacokinetic (PK) evaluable participants were defined as those who received at least one active pertuzumab and/or trastuzumab treatment and had at least one PK sample collected. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1389868|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
1389869|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
1389870|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
1389871|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
1389872|NCT01358877|Secondary|Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
1389873|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1389874|NCT01358877|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
1389875|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant’s assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
1389876|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant’s assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
1389877|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant’s assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
1389895|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
1389878|NCT01358877|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant’s assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.|Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
1389879|NCT01358877|Secondary|Change From Baseline in LVEF to Worst Post-Baseline Value|LVEF is the fraction of blood (in percent) pumped out of the heart’s left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.|Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of blood pumped out||Standard Deviation|Mean
1389880|NCT01358877|Secondary|Percentage of Participants With Secondary Cardiac Event|Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).|Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)|Safety population|||percentage of participants|||Number
1389881|NCT01358877|Secondary|Percentage of Participants With Primary Cardiac Event|Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.|Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)|Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received.|||percentage of participants|||Number
1389882|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for DRFI event at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
1389883|NCT01358877|Secondary|Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.|Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
1389884|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for RFI event at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
1389885|NCT01358877|Secondary|Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.|Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
1389886|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3|The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for death at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
1389887|NCT01358877|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any cause is reported.|Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
1389896|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
1389897|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
1389888|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for DFS event at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
1389889|NCT01358877|Secondary|Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.|Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
1389890|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for IDFS event (including SPNBC) at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
1389891|NCT01358877|Secondary|Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).|Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
1389892|NCT01358877|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for IDFS event (excluding SPNBC) at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
1389893|NCT01358877|Primary|Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.|Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
1389894|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
1394117|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1389901|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
1389902|NCT01358864|Primary|Sustained Virological Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
1389903|NCT01358864|Secondary|Early Treatment Success (ETS)|Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.|Week 4 and Week 8|FAS|||percentage of participants|||Number
1389904|NCT01358864|Secondary|Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
1389905|NCT01358825|Primary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL|Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
1389906|NCT01358825|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (up to Day 46)|The analysis was performed on the Total Cohort, which included all subjects enrolled in the study.|||Subjects|||Number
1389907|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PRP.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||μg/mL||95% Confidence Interval|Geometric Mean
1389908|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).|A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
1389909|NCT01358825|Primary|Concentrations of Antibodies Against Anti-HBs.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||mIU/mL||95% Confidence Interval|Geometric Mean
1389910|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).|Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
1389911|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1389912|NCT01358825|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).|Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
1389913|NCT01358825|Primary|Concentrations of Antibodies Against Anti-D and Anti-T|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||IU/mL||95% Confidence Interval|Geometric Mean
1389914|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
1389938|NCT01358708|Secondary|Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase|The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome).|At Screening and End of Double-Blind Treatment Phase|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made|||units on a scale (from 0 to 42)||Standard Deviation|Mean
1389915|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
1389916|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
1389917|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
1389918|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
1389919|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on dyspareunia were performed on a subgroup of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe dyspareunia at Baseline.|||Severity score||Standard Error|Mean
1389920|NCT01358760|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
1389921|NCT01358760|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||pH units||Standard Error|Mean
1389922|NCT01358760|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||percentage of superficial cells||Standard Error|Mean
1389923|NCT01358760|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||percentage of parabasal cells||Standard Error|Mean
1389924|NCT01358734|Other Pre-specified|Percentage of Participants Alive at One Year|Percentage of participants who survived at one year|Up to 12 months|ITT|||Percentage of participants||95% Confidence Interval|Number
1389925|NCT01358734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|Up to data cut-off of 01 May 2015; 36 months and 4 days|Safety population includes all participants who have received at least 1 dose of Investigational Product (IP).|||participants|||Number
1389926|NCT01358734|Secondary|Percentage of Participants With 30-day Treatment-related Mortality|30-day mortality rate is defined as death from any cause within 30 days after first dose.|30 days|ITT includes all randomized participants|||percentage of participants|||Number
1389927|NCT01358734|Secondary|Relapse-Free Survival (RFS)|Relapse-free survival is defined only for participants who achieve a CR or CRi and is measured as the interval from the date of first documented leukemia-free state (defined as less than 5% blasts in an aspirate sample) to the date of leukemia relapse, death from any cause, whichever occurs first, censoring at the last visit date for participants alive in continuous CR or CRi.|Up to 74 months||2019-04-30|04/2019||||
1389928|NCT01358734|Secondary|Event-Free Survival (EFS)|EFS is defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurs first|Up to 74 months||2019-06-30|06/2019||||
1389929|NCT01358734|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first observation of documented disease progression or death due to any cause whichever occurs first.|Up to 74 months||2019-04-30|04/2019||||
1389930|NCT01358734|Secondary|Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)|Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods) AND an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery (CRi) is defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission (PR) is defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if Auer rods are present).|Up to 74 months||2019-04-30|04/2019||||
1389931|NCT01358734|Secondary|Cytogenetic Complete Remission Rate (CRc)|The CRc response category is comprised of the subset of participants who had abnormal ctyogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment|Up to 74 months||2019-04-30|04/2019||||
1389932|NCT01358734|Secondary|Duration of Remission (DoR)|Duration of remission defined as the time from the date a response of CR or CRi is first documented until the date the participant has documented relapse after CR or CRi or dies from any cause, whichever occurs first.|Up to 74 months||2019-04-30|04/2019||||
1389933|NCT01358734|Secondary|Remission Rate (CR + CRi)|Remission Rate was defined as CR + CRi). Morphologic complete remission (CR) was defined as a leukemia-free state defined as less than 5% blasts in a bone marrow aspirate with bone marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods or persistence of extra-medullary disease) AND an absolute neutrophil count (ANC) of > 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and Red Blood Cell transfusion (RBC) independence (no RBC transfusions for 1 week before each assessment). Morphologic complete remission with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC (Absolute Neutrophil Count) may be < 1 x 10^9/L or plateletsmay be < 100 x 10^9/L.|Up to 74 months||2019-04-30|04/2019||||
1389934|NCT01358734|Primary|Kaplan Meier Estimates for One Year Survival|Overall Survival (OS) was defined as the time from randomization to death from any cause. OS was calculated using the date of randomization and date of death, or date of last follow-up for censored participants.|Up to 24 months|ITT included all randomized participants|||months||95% Confidence Interval|Median
1389935|NCT01358708|Secondary|Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study|Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study|8 weeks|Analysis conducted on the Intent-to-Treat population for both treatment phases|||participants|||Number
1389936|NCT01358708|Secondary|Stool Characteristics During the Open-Label Treatment Phase Using the BSFS|The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase ; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind study medication|||units on a scale (from 1 to 7)||Standard Deviation|Mean
1389937|NCT01358708|Secondary|Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind medication.|||units on a scale (from 0 to 500)||Standard Deviation|Mean
1389939|NCT01358708|Secondary|Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale|The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.|||units on a scale (from 1 ato 7)||Standard Deviation|Mean
1389940|NCT01358708|Secondary|Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.|||units on a scale (from 0 to 500)||Standard Deviation|Mean
1389941|NCT01358708|Secondary|Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered Yes to the following question at least 50% of the time during the 4-week treatment phase: Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|Weekly Assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; SGA data not available for one patient so that the analysis was performed on 16 rather than 17 patients|||percentage of participants|||Number
1389942|NCT01358708|Primary|Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered “Yes” to the following question at least 50% of the time during the 4-week treatment phase: “Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|Weekly Assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made|||percentage of participants|||Number
1389943|NCT01358578|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)|60 weeks|Full Analysis Set|||# participants tested positive|||Number
1389944|NCT01358578|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set|||Units on a scale||Standard Error|Mean
1389945|NCT01358578|Secondary|Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set|||units on scale||Standard Error|Mean
1389946|NCT01358578|Secondary|Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment||52 wks|Full analysis set|||participants who reached goal|||Number
1389947|NCT01358578|Secondary|Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)||52 wks|Full analysis set|||participants who reached goal|||Number
1389948|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator’s Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks|FAS|||participant acheiving goal|||Number
1389949|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS|||participant who acheived goal|||Number
1390313|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1389950|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS|||participant who acheived goal|||Number
1389951|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator’s Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject’s disease state at the time of the assessments, and does not attempt a comparison with any of the subject’s previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks||||participants acheiving goal|||Number
1389952|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks||||participants achieving goal|||Number
1389953|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the “average pain over the last 24 hours” score for week 12 of the double-blind period.|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||participants (responders)|||Number
1389954|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|A subject’s response to treatment was defined as the percentage reduction from the screening mean pain score to the “average pain over the last 24 hours” score for week 12 of the double-blind period.|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||participants (responders)|||Number
1389955|NCT01358526|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test."|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||participants (responders)|||Number
1389956|NCT01358526|Secondary|The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12|The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||95% Confidence Interval|Mean
1389957|NCT01358526|Primary|The “Average Pain Over the Last 24 Hours” at Week 12 of the Double-blind Period|The “average pain over the last 24 hours” score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.|24 hours (Week 12)|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale (0 - 10)||Standard Error|Mean
1389958|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score|The Q-LES-Q-SF is a 16-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living. The questionnaire was developed and validated for use in depressed outpatient subjects and has eight summary scales that reflect major areas of functioning: physical health, mood, leisure time activities, social relationships, general activities, work, household duties and school/coursework. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The Q-LES-Q-SF percentage maximum possible score is calculated as 100 × (Raw Score – 14 [Minimum Score]) / (70 [Maximum Score] – 14 [Minimum Score]). Higher percent maximum scores indicate better quality of life.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 12 lurasidone + Li/VPA subjects and 11 placebo +Li/VPA subjects did not have post-DB baseline Q-LES-Q-SF percent maximum possible score.|||units on a scale||Standard Error|Least Squares Mean
1389959|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score|The PIRS-2 is a 2-item self-report of insomnia assessed via a computer interface. Each item is scored from 0-3. The PIRS-2 total score is calculated as the sum of the 2 items. The PIRS total score ranges from 0 to 6. Higher scores are associated with greater severity of insomnia.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline PIRS-2 total score.|||units on a scale||Standard Error|Least Squares Mean
1389969|NCT01358357|Secondary|Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||Days||95% Confidence Interval|Median
1394118|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1389960|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient’s life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on treatment they were randomized. 63 lurasidone + Li/VPA subjects and 57 placebo +Li/VPA subjects did not have post-DB baseline SDS total score.|||units on a scale||Standard Error|Least Squares Mean
1389961|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 6 lurasidone + Li/VPA subjects and 3 placebo +Li/VPA subjects did not have post-DB baseline PANSS-P score.|||units on a scale||Standard Error|Least Squares Mean
1389962|NCT01358357|Secondary|Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline QIDS-SR16 total score.|||units on a scale||Standard Error|Least Squares Mean
1389963|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depressive symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1389964|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score|the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline YMRS total score.|||units on a scale||Standard Error|Least Squares Mean
1389965|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with a greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S depression score.|||units on a scale||Standard Error|Least Squares Mean
1389966|NCT01358357|Secondary|Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S mania score.|||units on a scale||Standard Error|Least Squares Mean
1389967|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score|The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1=Normal, not at all ill, to 7=Among the most extremely ill patients. a higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S overall score.|||units on a scale||Standard Error|Least Squares Mean
1389968|NCT01358357|Secondary|Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||percentage of participants|||Number
1389971|NCT01358357|Primary|Time to Recurrence of Mood Event During the Double Blind Treatment Phase|"A mood event is defined as one of the following during the double-blind phase:~(1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator)."|28 weeks (up to 33 weeks)|ITT (Intent to treat) population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||Days||95% Confidence Interval|Median
1389972|NCT01358175|Secondary|Assessment of Responders for ASAS Partial Remission|ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|16 weeks||||% responders|||Number
1389973|NCT01358175|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL|ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.|baseline and 16 weeks||||units on a scale||Standard Error|Least Squares Mean
1389974|NCT01358175|Secondary|Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS|SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|baseline, 16 weeks||||units on a scale||Standard Error|Least Squares Mean
1389975|NCT01358175|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI|"BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating  worst problem), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 – 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis."|Baseline and 16 weeks||||units on scale||Standard Error|Least Squares Mean
1389976|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response|ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks||||% responders|||Number
1389977|NCT01358175|Secondary|Change From Baseline in Serum hsCRP|The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.|Base line and Week 16|FAS. Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value are from mixed-effect model repeated measures (MMRM) with treatment, visit, TNF-alpha inhibitor status as factors, log(e) baseline and weight as covariates.|||ratio||Standard Error|Least Squares Mean
1389978|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response|ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.|||% responders|||Number
1389979|NCT01358175|Primary|Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response|ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.|||% responders|||Number
1389980|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.|||mm||Standard Deviation|Mean
1389981|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.|||mm||Standard Deviation|Mean
1389982|NCT01357980|Secondary|Quality of Life (QoL) Total Summary Score|"Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score.~The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0=“Not at all” to 4=“Extremely” for the first 6 items, from 0=“Never” to 4=“Always” for item 7 and from 0=”Always” to 4=”Never” for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated.~Total score has been calculated as the mean of all the items completed among the 8 items.~Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL."|Baseline, 14, 42 and 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
1389983|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||participants|||Number
1389984|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 42|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||participants|||Number
1389985|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject’s treatment response was assessed by the physician and graded as ‘markedly worse’, ‘much worse’, ‘worse’, ‘slightly worse’, ‘no change’, ‘slightly improved’, ‘improved’, ‘much improved’, or ‘markedly improved’.|Day 14|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||participants|||Number
1389986|NCT01357980|Secondary|Urodynamics:Maximum Detrusor Pressure|Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.|||cm water (cm H20)||Standard Deviation|Mean
1389987|NCT01357980|Secondary|Urodynamics: Maximum Cystometric Capacity|Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.|||mL||Standard Deviation|Mean
1389988|NCT01357980|Primary|Daily Incontinence Episode Frequency (IEF)||Baseline and Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||episodes per day||Standard Deviation|Mean
1389989|NCT01357915|Secondary|Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Blood||At Month 48 and Month 60|||2025||||
1389990|NCT01357915|Secondary|Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies|CMV infection was determined by the anti-CMV proteins antibody response, using ELISA. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60) in the Vaccine group (GSK149203A S- Group). All subjects from the Reference group (GSK149203A S+ Group) were positive for the anti-CMV tegument IgG antibodies at the screening visit.|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1389991|NCT01357915|Secondary|Specific B Cell Memory Immune Response for gB|Memory B cells specific to the CMV gB antigen, as assessed by the Enzyme-linked Immunosorbent Spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||B cells/million cells||Inter-Quartile Range|Median
1389992|NCT01357915|Secondary|Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers|Among the immune markers determined by the Intracellular cytokine staining (ICS) were Interferon-gamma (INF-γ), Interleukin-2 (IL-2), Tumor necrosis factor-alpha (TNF-α), and CD40-Ligand (CD40-L). Data were collected for all subjects at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1389993|NCT01357915|Secondary|Avidity Towards Anti-gB IgG Antibodies|Avidity for anti-gB IgG antibodies was assessed by the ELISA Avidity index method in all subjects, at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Avidity Index||Inter-Quartile Range|Median
1389994|NCT01357915|Primary|Number of Subjects With Neutralizing Response Against Anti-CMV Antibodies||At Month 48 and Month 60|||2025||||
1389995|NCT01357915|Primary|Concentrations of Antibodies Against Anti-gB IgG|Anti-gB IgG antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL), as assessed by Enzyme-linked Immunosorbent Assay (ELISA). Data were collected at Month 48 (M48) and Month 60 (M60) from all subjects.|At Month 48 and Month 60|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1389996|NCT01357889|Primary|Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase|To assess the bioequivalence of the two formulations of study drug, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter Cmax estimated from the BE phase. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1389997|NCT01357889|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase|To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide Pharmacokinetic (PK) Population: all participants who had sufficient samples to calculate PK parameters of albiglutide. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
1389998|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit|ECG parameters include heart rate, QRS interval, QTinterval, QT interval – Bazett correction (QTcB), QT interval – Fridericia correction (QTcF), RR interval, and PR interval. Criteria for values of potential concern were determined by the medical monitors. For the QRS interval, an increase of >25% when Baseline QRS >100 milliseconds (msec) and an increase of >50% when Baseline QRS <=100 msec was considered to be of clinical concern. For QTcF, a >=60 msec change from Baseline was considered to be of clinical concern. For the PR interval, an increase of >25% when Baseline PR >200 msec and an increase of >50% when Baseline PR <=200 msec was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the Safety Population.|||Participants|||Number
1389999|NCT01357889|Secondary|Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17|A complete physical examination was performed at Screening and at Week 17 and included evaluation of the following organ or body systems: skin (including injection site); head; eyes; ears, sose, and throat (ENT); thyroid; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; central nervous system (CNT); and extremities. The assessment was categorized as improved, no change, worsened, and not done.|Screening and Week 17|Safety Population. Only participants analyzed at Week 17 are presented.|||Participants|||Number
1390000|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit|Vital signs measured included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Criteria for values of potential concern were determined by the medical monitors. For SBP, a decrease or increase >30 millimeters of mercury (mmHg) from Baseline was considered to be of clinical concern. For DBP, a decrease or increase >20 mmHg from Baseline was considered to be of clinical concern. For heart rate, a decrease or increase >30 beats per minute (bpm) was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1390001|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit|Criteria for values of potential concern were determined by the medical monitors. For hematocrit, a >0.1 decrease from Baseline was considered to be of clinical concern. For hemoglobin, a >25 grams per liter (g/L) decrease from Baseline was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1390002|NCT01357889|Secondary|Number of Participants With Indicated Adverse Events of Special Interest|Adverse events of special interest included cardiovascular events, hypoglycemic events, pancreatitis events, thyroid events, gastrointestinal (GI) events, diabetic retinopathy events, systemic allergic reactions (SAR), injection site reactions (ISR), and liver events (AEs from investigations and hepatobiliary disorders were considered).|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study|Safety Population|||Participants|||Number
1390021|NCT01357850|Secondary|Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS)|Change in Baseline in cardiac and liver fat by proton spectroscopy was planned at Baseline and Week 13. The protocol allowed for sites to perform all or only efficacy assessments, depending on site designation, capability and feasibility. No sites that enrolled participants into this study were able to perform this outcome measure.|Baseline and Week 13|||||||
1390135|NCT01355978|Secondary|Device Preference|"5-point Likert Scale completed at the end or the 5-day study period~- Preference Scale: 5 = Max preference (Prefer to use the test device), 1 = Min preference (Do not prefer to use the test device)"|At conclusion of subject's participation (up to two weeks)||||units on a scale||Full Range|Median
1390003|NCT01357889|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Hypoglycemic events are excluded from this table, except for serious adverse events.|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study|Safety Population|||Participants|||Number
1390004|NCT01357889|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17|This analysis used the LOCF method for missing post-Baseline FPG values. FPG values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on ANCOVA: Change = treatment + Baseline FPG + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF|||millimoles per liter||Standard Error|Least Squares Mean
1390005|NCT01357889|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This analysis used the last observation carried forward (LOCF) method for missing post-Baseline HbA1c values. HbA1c values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on analysis of covariance (ANCOVA): Change = treatment + Baseline HbA1c + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF: all participants who received a dose of study medication and who had a Baseline measurement and at least 1 post-Baseline HbA1c or fasting plasma glucose (FPG) measurement. Only participants available at the specified time point were analyzed.|||Percentage of HbA1c in blood||Standard Error|Least Squares Mean
1390006|NCT01357889|Secondary|Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase|The apparent volume of distribution in the terminal phase (V/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1390007|NCT01357889|Secondary|Apparent Clearance of Albiglutide in the BE Phase|The apparent clearance (CL/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
1390008|NCT01357889|Secondary|t1/2 of Albiglutide in the BE Phase|The terminal elimination half-life (t1/2) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1390009|NCT01357889|Secondary|Cmax of Albiglutide in the BE Phase|Cmax of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1390010|NCT01357889|Secondary|Tmax and Tlag of Albiglutide in the BE Phase|Time of the maximum observed plasma concentration (tmax) and the observed time prior to the first quantifiable plasma concentration (tlag) of albiglutide in the BE Phase were measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or terminal elimination rate constant not estimable were excluded.|||Hours||Full Range|Median
1390011|NCT01357889|Secondary|AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase|The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of albiglutide in the BE Phase were measured. AUC is a measure of how much albiglutide is in the blood at certain time points. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PK Population.|||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
1390033|NCT01357720|Primary|Seroprotection Rate: Anti-diphtheria Toxoid Antibodies|Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
1390034|NCT01357720|Primary|Seroprotection Rate: Anti-hepatitis B Surface Antibodies|Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
1390012|NCT01357889|Secondary|Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase|The presence of anti-albiglutide antibodies after repeat-dose administration was assessed using a qualified enzyme-linked immunosorbent assay. The assay involved screening, confirmation, and titration steps (tiered-testing approach). The number of participants who tested positive for anti-albiglutide antibodies are presented by visit.|Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)|Safety Population: all par. who received at least 1 dose of study medication. Only those par. available at the specified time points were analyzed (represented by n= X, X in the category titles). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Safety Population.|||Participants|||Number
1390013|NCT01357889|Secondary|Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)|The trough concentration of albiglutide at Week 5, Week 9, Week 13, Week 17 (EOT), and Week 25 (Follow-up) following multiple-dose administration was estimated. The time and date of sample collection pre-dose was to be recorded.|Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)|PK Concentration Population (PKCP): participants (par.) in the MDP for whom a PK sample was collected/analyzed. Only par. available at the specified time points were analyzed (n= X, X in the category titles). Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PKCP.|||ng/mL||Standard Deviation|Mean
1390014|NCT01357850|Secondary|Number of Participants With Adverse Events by the Indicated Severity|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Severity categories: Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities;Moderate: an event that was sufficiently discomforting to interfere with normal everyday activities; Severe: an event that prevents normal everyday activities.|Baseline and Week 13|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1390015|NCT01357850|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Please refer to the AE/SAE section for further details.|Baseline and Week 13|All Subject Population: all randomized participants who received >= 1 dose of study medication. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1390016|NCT01357850|Secondary|Change From Baseline in Quality of Life as Assessed by the Minnesota Living With Heart Failure Questionnaire|Minnesota living with heart failure questionnaire (MLHFQ) is a validated instrument to measure participant-reported quality of life at Baseline and Week 13. For each of 21 items, participants rated the effects of heart failure and its treatment on physical, socioeconomic and psychological aspects of their life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each participant to indicate their response using a 6-point scale (ranging from 0 to 5, 0=no, 1=very little, and 5=very much). The min and max scores can range from 0 to 105. The likert scale measures the effect of heart failure and treatments for heart failure on an individual's ability to live as they want. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||95% Confidence Interval|Geometric Mean
1390017|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Insulin|Blood samples for biomarker analysis of fasting levels of insulin were collected at Weeks 1, 7 and 13. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||picomole per liter (pmol/L)||Standard Error|Geometric Mean
1390018|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Glucose, and Free Fatty Acids (FFA)|Blood samples for biomarker analysis of fasting levels of glucose and FFA were collected at Weeks 1, 7 and 13; glucose was also collected at Weeks 2, 4, 6, 8, 10, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Millimole per liter (mmol/L)||Standard Error|Geometric Mean
1390019|NCT01357850|Secondary|Change From Baseline in Serum N-terminal Fragment Brain Natriuretic Peptide (NT-BNP) Level|Baseline is defined as the last available assessment on or prior to the first dose of study medication. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Change from Baseline at Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Nanogram per liter||Standard Error|Geometric Mean
1390020|NCT01357850|Secondary|Change From Baseline in Exercise Capacity Assessed by 6-minute Walk Test|The six minute walk test was performed at Baseline and Week 13. All participantss were given standardized instructions and the distance walked was measured. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Meters||95% Confidence Interval|Geometric Mean
1405008|NCT01220466|Other Pre-specified|Percentage of Eyes With Best Spectacle Corrected Visual Acuity (BSCVA) Worse Than 20/40||6 Months|Percentage of eyes with BSCVA worse than 20/40|||percentage of eyes|Participants|95% Confidence Interval|Number
1390022|NCT01357850|Secondary|Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS)|Participants underwent a CMR scan performed on a 3 Tesla MR system at Baseline and Week 13 to assess cardiac mass, volumes (global function and dilatation), strain and torsion, cardiac and liver lipid content and cardiac energy metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|Magnetic Resonance Substudy Population (MRS): all randomized participants who participated in the MRS substudy and had valid Baseline and/or Week 13 assessments for either PCr/ATP via 31P MRS. Only those participants available at the specified time points were analyzed.|||ratio||95% Confidence Interval|Least Squares Mean
1390023|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left/right ventricular ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.|||Grams||Standard Error|Geometric Mean
1390024|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess LV and RV ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.|||Milliliters||Standard Error|Geometric Mean
1390025|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left ventricular (LV) and right ventricular (RV) ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Only those participants available at the specified time points were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population: all randomized participants who participated in the CMR substudy and had valid Baseline and/or Week 13 assessments for >= 1 one of the imaging parameters of LV and RV function assessed by CMR (LVEF, LV and RV volumes in systole and diastole, LV mass), myocardial strain assessed by myocardial tagging indices.|||Percentage||Standard Error|Geometric Mean
1390026|NCT01357850|Secondary|Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Milliliters||Standard Error|Geometric Mean
1390027|NCT01357850|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave, and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Error|Geometric Mean
1390028|NCT01357850|Primary|Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing|Peak VO2 was measured at Baseline and Week 13. Participants performed a maximal exercise test limited by dyspnea or fatigue on a cycle ergometer. After a rest period, the workloads were increased in a step fashion by 25 watts every 3 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Milliliters per kilogram per minute||95% Confidence Interval|Least Squares Mean
1390029|NCT01357850|Primary|Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest|MVO2 was estimated by measuring the rate of myocardial clearance of 11C-activity which represents overall myocardial oxidative flux through the TCA cycle. Cardiac work was measured by echocardiography and cardiac efficiency index was calculated as work (by echocardiography) divided by MVO2. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||millimeters of mercury/liter/minute2||95% Confidence Interval|Least Squares Mean
1390030|NCT01357850|Primary|Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging|FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and had >= 1 on treatment assessment. Only those participants available at the specified time points were analyzed.|||micromoles per gram per minute||95% Confidence Interval|Least Squares Mean
1390031|NCT01357720|Primary|Seroprotection Rate: Anti-B. Pertussis Antibodies|Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
1390032|NCT01357720|Primary|Seroprotection Rate: Anti-tetanus Toxoid Antibodies|Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
1390036|NCT01357655|Secondary|Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug.|From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)|All Treated Participants; Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).|||participants|||Number
1390037|NCT01357655|Secondary|Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
1390038|NCT01357655|Secondary|Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
1390039|NCT01357655|Secondary|Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
1390040|NCT01357655|Secondary|Complete Molecular Response at Any Time||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
1390041|NCT01357655|Primary|Number of Participants With Major Molecular Response|Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.|Baseline up to 12 months|Efficacy Sample: all treated participants with at least one assessment on treatment. Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).|||Participants|||Count of Participants
1390042|NCT01357616|Secondary|Mean IOP Change From Baseline (5 PM) at Week 8|Mean IOP change from baseline (5 PM) at Week 8 was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||mmHg||Standard Deviation|Least Squares Mean
1390043|NCT01357616|Secondary|Mean IOP Change From Baseline at 11 AM|Mean IOP change from baseline at 11 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||mmHg||Standard Deviation|Least Squares Mean
1390044|NCT01357616|Secondary|Mean IOP Change From Baseline at 9 AM|Mean IOP change from baseline at 9 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||mmHg||Standard Deviation|Least Squares Mean
1390045|NCT01357616|Primary|Mean Diurnal IOP Change From Baseline at Week 8|Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||millimeters mercury (mmHg)||Standard Deviation|Least Squares Mean
1390046|NCT01357551|Secondary|Estimated Metabolic Minutes of Moderate Physical Activity Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks||||metabolic minutes per week||Standard Deviation|Mean
1390047|NCT01357551|Secondary|Estimated Metabolic Minutes of Walking Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks||||metabolic minutes per week||Standard Deviation|Mean
1390048|NCT01357551|Secondary|Estimated Daily Caloric Intake|Based on self-report using Block Brief Food Frequency Questionnaire|56 weeks||||kcal per day||Standard Deviation|Mean
1390049|NCT01357551|Primary|Weight||56 weeks post-randomization||||kilograms||Standard Deviation|Mean
1390050|NCT01357512|Secondary|Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups|Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.|at the end of the study (up to 1 year)|||||||
1390120|NCT01356407|Secondary|Percentage of Successful Completion of Colonoscopy|An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||Percentage of Subjects (%)|||Number
1390051|NCT01357512|Secondary|Number of Positive Biopsies in MRI and no MRI Groups|The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.|at the end of the study (up to 1 year)||||number of cancer-positive biopsy cores||Inter-Quartile Range|Median
1390052|NCT01357512|Primary|Number of Prostate Cancer Diagnoses in MRI and no MRI Groups|The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.|at the end of the study (up to 1 year)||||participants|||Number
1390053|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum II|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score on a scale||Standard Error|Least Squares Mean
1390054|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum I|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score on a scale||Standard Error|Least Squares Mean
1390055|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum II|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment|||Number of participants|||Number
1390056|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum I|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment|||Number of participants|||Number
1390081|NCT01356966|Secondary|Change in Mean Central Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks||||percent||Standard Error|Mean
1390136|NCT01355978|Primary|Device Tidal Volume|Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).|Periodically over six hours x 5 days||||mL||Standard Deviation|Mean
1390057|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech, and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum II|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
1390058|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum I|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
1390059|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum II|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum II included patients whose FMR1 gene was partially methylated|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Participants|||Number
1390060|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum I|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Participants|||Number
1390061|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum II Patients|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum II included patients whose FMR1 gene was partially methylated|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
1390062|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum I Patients|The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being “very much improved”, 4 being “no change” to 7 being “very much worse”). Stratum I included patients whose FMR1 gene was fully methylated.|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
1390063|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum I Patients Exposed to the Two Lower Doses of AFQ056 (25 mg Bid and 50 mg Bid)|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose FMR1 gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
1390064|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum II Patients Exposed to All 3 Doses of AFQ056|The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum II included patients whose FMR1 gene was partially methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
1390065|NCT01357239|Primary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the Aberrant Behavior Checklist–Community Edition (ABC-CFX) Total Score in Stratum I Patients Exposed to AFQ056 100 mg Bid|The Aberrant Behavior Checklist-Community edition (ABC-C) is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (“not at all a problem”) to 3 (“problem is severe in degree”) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose Fragile X Mental Retardation 1 (FMR1) gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
1390066|NCT01357161|Secondary|Part 2: Median Overall Survival (OS) in Months|OS was defined as the time from randomization to death due to any cause, reported in months. Participants without documented death at the time of analysis were censored at the date last known to be alive. For this endpoint, all randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not evaluated for OS.|Up to 57 months|ITT Population: All randomized participants in Part 2|||months||95% Confidence Interval|Median
1390067|NCT01357161|Secondary|Part 2: ORR Per GCIG Criteria Based on Both Enhanced RECIST 1.1 and CA125 Level by Independent Radiology Review|ORR defined as the percentage of participants with best response of confirmed PR or CR based both on imaging per enhanced RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR defined by enhanced RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have had reduction in short axis to <10 mm. PR was defined by enhanced RECIST 1.1 as ≥30% decrease in SOV of target lesions, taking as reference baseline SOV. Response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from pretreatment sample. Response must have been confirmed and maintained for ≥28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. All randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|ITT Population: All randomized participants in Part 2|||percentage of participants||95% Confidence Interval|Number
1390068|NCT01357161|Primary|Parts 1 and 2: Percentage of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that discontinued study treatment (paclitaxel, carboplatin, or MK-1775) due to an AE was reported for each treatment arm.|Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)|"Part 1: All participants who received at least one dose of study treatment during the open-label period.~Part 2: All randomized participants who received at least one dose of study treatment. 2 participants were randomized to the Part 2 placebo arm but were not treated."|||percentage of participants|||Number
1390069|NCT01357161|Primary|Parts 1 and 2: Percentage of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.|Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)|"Part 1: All participants who received at least one dose of study treatment during the open-label period.~Part 2: All randomized participants who received at least one dose of study treatment. 2 participants were randomized to the Part 2 placebo arm but were not treated."|||percentage of participants|||Number
1390082|NCT01356966|Primary|Change in Resting Muscle Sympathetic Nerve Activity (MSNA)||Baseline, 12 weeks|Two subjects withdrawn from each arm due to adverse events. Additionally, two subjects from the treatment group and one subject from the placebo group were not included in this analysis because an adequate MSNA neurogram was unable to be obtained at the end of the study.|||bursts/minute||Standard Error|Mean
1390083|NCT01356940|Secondary|Stepcount|daily stepcount recorded by an accelerometer and averaged over 1 week of wear|10 weeks|||||||
1390084|NCT01356940|Primary|Peak Activity Index|peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention|10 weeks||||change in strides per minute||Standard Deviation|Mean
1390137|NCT01355705|Secondary|Time-to-next Treatment||9 months||||days||Full Range|Median
1390070|NCT01357161|Primary|Part 1: Number of Participants With a Dose Limiting Toxicity (DLT)|DLTs assessed during first 21-day cycle of Part 1 and defined as toxicities that met pre-defined severity criteria, were possibly, probably, or definitely related to triplet therapy, and could possibly result in a change in the given dose. Hematologic DLTs included Grade (Gr) 3 or Gr 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and any Gr 4-5 hematological toxicity EXCEPT Gr 4 anemia, leukopenia, lymphopenia, neutropenia lasting <7 days, and thrombocytopenia lasting <4 days, except if a platelet transfusion was required. Non-hematologic DLT defined as any Gr 3, 4, or 5 nonhematologic toxicity EXCEPT: Gr 3 nausea, vomiting, diarrhea, or dehydration judged by Investigator and SPONSOR to occur in setting of inadequate compliance with supportive care measures and last for less than 48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, or clinically non-significant, treatable or reversible lab abnormalities.|During Cycle 1 of Part 1 (first 21 days)|All participants who received ≥1 dose of study treatment during Cycle 1 of Part 1 open-label period and were evaluable at the time of the interim analysis. One participant took a prohibited medication during Part 1 and was considered unevaluable. Two participants enrolled into Part 1 after the interim analysis database lock and were not included.|||participants|||Number
1390071|NCT01357161|Secondary|Part 2: Median PFS in Weeks Based on RECIST 1.1 by Independent Radiology Review|PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on RECIST 1.1 criteria. According to RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR a ≥20% increase in the sum of target lesion diameters (SOD) taking as reference the nadir (smallest SOD recorded since treatment started). PFS was analyzed for all randomized participants in Part 2 using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|ITT Population: All randomized participants in Part 2|||weeks||95% Confidence Interval|Median
1390072|NCT01357161|Secondary|Part 1: Objective Response Rate (ORR) Per Gynecological Cancer Intergroup (GCIG) Criteria Based on Both RECIST 1.1 and Cancer Antigen 125 (CA-125) Level by Independent Radiology Review|ORR was defined as the percentage of participants whose best response was confirmed partial response (PR) or complete response (CR) based both on imaging per RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. A response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from a pretreatment sample. The response must have been confirmed and maintained for at least 28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. Only evaluable Part 1 participants were included in this analysis.|Up to 57 months|All participants receiving MK-1775 (225 mg) during Part 1 and evaluable at the time of the interim analysis. One participant took a prohibited medication during Part 1 and was considered unevaluable. Two participants enrolled into Part 1 after the interim analysis database lock and were not included.|||percentage of participants||95% Confidence Interval|Number
1390073|NCT01357161|Primary|Part 2: Median Progression-free Survival (PFS) in Weeks Based on Enhanced Response Evaluation Criteria In Solid Tumors Version 1.1 (Enhanced RECIST 1.1) by Independent Radiology Review|PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on enhanced RECIST 1.1 criteria. According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) >20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees. PFS was analyzed for Part 2 participants only using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|Intent to Treat (ITT) Population: All randomized participants in Part 2|||weeks||95% Confidence Interval|Median
1390074|NCT01357148|Primary|Number of Participants Taking Concomitant Medications||Up to approximately 28 months||||participants|||Number
1390075|NCT01357148|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months||||participants|||Number
1390076|NCT01357148|Primary|Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl||Up to approximately 28 months||||years||Standard Deviation|Mean
1390077|NCT01357148|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months||||participants|||Number
1390078|NCT01357135|Primary|Percentage of Participants With Strict Changes in Initial Dual Therapy|Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.|Up to 3 years|All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.|||Percentage of Participants|||Number
1390079|NCT01357135|Primary|Median Duration (in Months) of Initial Dual Therapy|The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.|Up to 3 years|All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.|||months||95% Confidence Interval|Median
1390080|NCT01356966|Secondary|Change in Heart-rate-corrected Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows: HR-corrected AIx = -0.39 x (75 - HR) + AIx. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks||||percent||Standard Error|Mean
1390085|NCT01356667|Secondary|Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.|The Addiction Severity Index, Native American Version will be utilized to assess problem severity in alcohol use, drug use, employment, family and social relationships, legal, psychological, and medical status. In addition, additional information with regards to mental health characteristics will be obtained from the Brief Symptom Inventory.|Change from Baseline in Mental Health and psychosocial characteristics at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.||||||
1390086|NCT01356667|Secondary|Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension|The General Alcoholics Anonymous Tools of Recovery (GAATOR 2.1) will be provided in order to determine and track patient's knowledge of the 12-steps during their participation in the DARTNA treatment program.|Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.||||||
1390087|NCT01356667|Primary|Drug and Alcohol Use as a Measure of Treatment Effectiveness|Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.|Change from Baseline in Drug and Alcohol use at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.||||||
1390088|NCT01356628|Secondary|Response Rate (RR)|The best overall response is the best response recorded from the start of treatment until disease progression or recurrence. The objective response rate is the proportion of subjects with either a confirmed complete response (CR) or a confirmed partial response (PR) as determined using modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Subjects with the response of stable disease (SD) will be recorded and documented. Disease control rate defined as CR+PR+SD will be calculated for all subjects treated with PD-0332991.|Every 8 weeks||2019-12-31|12/2019||||
1390089|NCT01356628|Secondary|Overall Survival (OS)|Overall survival (OS) is measured from the entry onto the trial until death of any cause. Date and cause of death will be recorded. The cause of death will be categorized as either cancer-related or cancer-unrelated.|Every 2 weeks during first 3 cycles, then monthly during treatment. Then Day 28, Day 56 and every 3 months from last administration of protocol directed therapy or death||2019-12-31|12/2019||||
1390090|NCT01356628|Secondary|Number of Adverse Events|The number and nature of adverse events as a measure of safety and tolerability. Safety analysis will be conducted on all patients who receive at least one dose of PD-0332991 during the study period or follow-up. An adverse event is any unfavorable and unintended sign, symptom, syndrome or illness that develops during the period of observation in the clinical study, including a new illness or condition, worsening of a concomitant illnesses or condition, effect of the study medication or combination of 2 or more factors.|From date of randomization through study completion, assessed up to 100 months||||Adverse Events|||Number
1390091|NCT01356628|Primary|Time to Disease Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST Version 1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progression.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||months||Full Range|Mean
1390092|NCT01356602|Secondary|C-reactive Protein Level|A central laboratory was used for analysis of all blood samples collected.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mg / L||95% Confidence Interval|Least Squares Mean
1390093|NCT01356602|Secondary|Amount of Rescue Medication Taken (mg)|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||milligrams (mg)||Standard Deviation|Mean
1390094|NCT01356602|Secondary|Time to First Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Hours||Full Range|Median
1390095|NCT01356602|Secondary|Proportion of Patients With Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Particpants|||Number
1390096|NCT01356602|Secondary|Physician's Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
1390097|NCT01356602|Secondary|Physician's Assessment of Erythema|The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
1390098|NCT01356602|Secondary|Physician's Assessment of Swelling|The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Partipants|||Number
1390099|NCT01356602|Secondary|Physician's Assessment of Tenderness|The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that “there is pain”, 2 = patient states “there is pain and winces” and 3 = patient states “there is pain, winces and withdraws” on palpation or passive movement of the affected study joint.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
1390100|NCT01356602|Secondary|Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
1390101|NCT01356602|Secondary|Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
1390102|NCT01356602|Secondary|Time to Resolution of Gouty Arthritis Flare as Reported by Patient|Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Hours||95% Confidence Interval|Median
1390103|NCT01356602|Secondary|Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Hours||95% Confidence Interval|Median
1390104|NCT01356602|Secondary|Time to the First New Gouty Arthritis Flare|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Days||95% Confidence Interval|Median
1390105|NCT01356602|Secondary|Number of Patients With at Least One New Gouty Arthritis Flare After Baseline|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Particpants|||Number
1390106|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Patients|||Number
1390119|NCT01356407|Secondary|Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)|At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality “adequate for clinical diagnostic purposes” (Y/N). The total Ottawa Scale scores was correlated with ‘adequate’ or ‘inadequate’ quality of bowel preparation for clinical diagnostic purposes|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1390107|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 0-100mm VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Millimeters||Standard Error|Least Squares Mean
1390108|NCT01356602|Secondary|Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Millimeters||Standard Error|Least Squares Mean
1390109|NCT01356602|Primary|Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Millimeters||Standard Error|Least Squares Mean
1390110|NCT01356589|Secondary|Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants. 'N' (number of participants analyzed) included those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1390111|NCT01356589|Secondary|Number of Full Hemoglobin Cycles Per Participant|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants.|||cycles||Standard Deviation|Mean
1390112|NCT01356589|Primary|Percentage of Participants With at Least One Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.|9 months|Analysis population included all treated participants.|||percentage of participants|||Number
1390113|NCT01356498|Secondary|Gout Flare Incidence|Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.|Assessed in 3-month intervals up to 2 years|The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.|||Percentage of participants|||Number
1390114|NCT01356498|Secondary|Gout Flare Frequency|The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment|Up to 2 years|Analysis is based on ITT population, and is presented by intervals of time on pegloticase|||Flares||Standard Deviation|Mean
1390115|NCT01356498|Secondary|Patient Reported Outcome: SF-36 Physical Component Summary Score|"SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best).~The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status."|RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101|Number of participants was the subset of the ITT population with SF-36 baseline data|||units on a scale||Standard Deviation|Mean
1390116|NCT01356498|Secondary|Tophus Response|Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.|Up to 2 years|ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.|||participants|||Number
1390117|NCT01356498|Primary|Uric Acid (mg/dL)|Uric acid measured at 3 month-intervals|Week 13, Week 25, Week 53, Week 101|ITT|||mg/dL||Standard Deviation|Mean
1390118|NCT01356407|Secondary|Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation|The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||participants|||Number
1390132|NCT01356147|Secondary|Elimination of White Blood Cells and Bacteria From Tracheal Aspirate|Number of infants with Tracheal aspirate WBC present on review of smear at end of therapy Bacterial load judged on presence of positive or negative culture in Tracheal aspirate|During first week of treatment or until extubation whichever is earlier||||participants|||Number
1390121|NCT01356407|Secondary|Ottawa Scale Score by Colon Segment|Mean Ottawa Scale scores, and score categories (from 'excellent’ to ‘bad’), are summarised by colon segment together with the overall fluid content score|Day 2|All randomized patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1390122|NCT01356407|Secondary|Patient Response to Acceptability and Tolerability Questionnaire|On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set|||units on a scale||Standard Deviation|Mean
1390123|NCT01356407|Primary|The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation|The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 (‘excellent’ visibility) to 4 (‘inadequate’ visibility); The component scores for each of the colon segment are added together, along with an overall ‘fluid’ score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)|day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1390124|NCT01356277|Secondary|Annualized Change in Estimated Glomerular Filtration Rate (eGFR)|Change in estimated glomerular filtration rate, estimated using the Schwartz equation for those < 18 y. and the CKD-EPI equation for those 18y and older, standardized to a 12-month period.|12 months|included all those with eGFR data available|||ml/min/1.73m^2||Inter-Quartile Range|Median
1390125|NCT01356277|Secondary|Acute Rejection Rate|The acute rejection rate, measured as rejections per 100 person-years of observation.|12 months|included all those who participated during the intervention interval|||events per 100 person-years|||Number
1390126|NCT01356277|Secondary|Self-reported Timing Adherence|Self-reported timing adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken up to 2 hours after the prescribed time in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.|12 months|included all those who participated during the intervention interval|||percentage of doses taken on time||Standard Deviation|Mean
1390127|NCT01356277|Secondary|Self-reported Taking Adherence|Self-reported taking adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.|12 months|included all those who participated during the intervention interval|||percentage of prescribed doses taken||Standard Deviation|Mean
1390128|NCT01356277|Secondary|Standard Deviation (SD) of Tacrolimus Trough Levels|The SD of all tacrolimus trough levels done for clinical care (except during hospitalizations or illnesses) were calculated for participants with >=3 tacrolimus levels.|12 months||||standard deviation units||Inter-Quartile Range|Median
1390129|NCT01356277|Primary|Timing Adherence|"Daily timing adherence, defined as the percentage of doses taken within 1 hour before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given.~To summarize timing adherence for each arm, we calculated the total percentage of days of observation for which there was 100% timing adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which timing adherence was 100%, summed across all participants."|12 months|We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare timing adherence between the intervention and control groups during the intervention interval. An additional ‘as-treated’ analysis was also conducted. All available data were included.|||% of days with 100% timing adherence|||Number
1390130|NCT01356277|Primary|Taking Adherence|"Daily taking adherence, defined as the percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given.~To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants."|12 months|We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare taking and timing adherence between the intervention and control groups during the intervention interval. An additional ‘as-treated’ analysis was also conducted. All available data were included.|||% of days with 100% taking adherence|||Number
1390131|NCT01356147|Secondary|Number of Infants Requiring Ventilator Support|number of infants extubated during treatment/sham|7 days||||participants|||Number
1390133|NCT01356147|Primary|Percent Reduction in Oxygen Requirement From Baseline|Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation|First week of treatment or extubation||||percentage FiO2||Full Range|Mean
1390138|NCT01355705|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:~Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,~Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline~New or increased bone lesions or plasmacytomas~Serum calcium > 11.5 mg/dL (attributed to increased plasma cells)"|9 months||||days||Full Range|Median
1390139|NCT01355705|Secondary|Duration of Response (DOR)||140 days||||days||Full Range|Median
1390140|NCT01355705|Primary|Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria|"Modified International Myeloma Working Group Uniform Response Criteria:~Complete (CR)=~Negative for monoclonal protein (MP) in urine (U) and serum (S) +~No tissue plasmacytomas (PC) +~<5% plasma cells (PCs) in marrow (M)~Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M~Near CR (nCR)= CR, except MP persists in U and S~Partial (PR)= S MP ≤50%, + U MP ≤90% or <200 mg/24 hours (hr)~Very Good PR (VGPR)= in S MP ≤90%, + U MP <100 mg/24 hr~Minimal (MR)=~S MP ≤51-75%, +~If light chain is excreted, reduced 50-89%/24 hr that is also >200 mg/24 hr, +~No increase in lytic bone lesions~Progressive disease (PD)= any of:~S MP ≥125% and/or ≥+0.5 g/dL,~U MP ≥125% and/or ≥+200 mg/24 hr~New or increased bone lesions/PC~S calcium >11.5 mg/dL (attributed to increased PCs)~PD after CR/sCR=~Reappearance of S or U MP~≥5% clonal PCs in M~New PC, lytic bone lesions, hypercalcemia~Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD"|12 weeks||||percentage of participants|||Number
1390141|NCT01355679|Secondary|Activity of Treatments Chosen Based on Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year||||Days||95% Confidence Interval|Mean
1390142|NCT01355679|Secondary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year||||percentage of participants with PR or CR|||Number
1390143|NCT01355679|Secondary|Number of Participants With Adverse Events as a Measure of Safety|To determine the safety of allowing a molecular tumor board to determine individualized treatment plans|1 year||||participants|||Number
1390144|NCT01355679|Primary|Percentage of Participants That Are Able to Meet Feasibility Parameters.|Feasibility parameter defined as: Enrollment onto study, quality mRNA obtained, gene chip completed, tumor board held, medical monitor review and approval, start of treatment by 21 days post biopsy/surgical resection date, and then completion of 1 cycle of therapy.”|1 year|All subjects had soft tissue disease in which biopsy was possible. Two subjects were deemed ineligible due to benign tumor type after biopsy.|||percentage of participants|||Number
1390145|NCT01355627|Secondary|Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele|Non-clinically evident pseudomeningocele was defined as a cerebrospinal fluid accumulation found on a postoperative computerized tomography (CT) or magnetic resonance imaging (MRI) scan which fulfilled the following criteria according to the radiologist assessment before Day of Discharge: CT Scan-Fluid accumulation seen as Hypodense signal, MRI Scan-Fluid accumulation seen as Hypointense signal in T1-weighted image and/ OR Fluid accumulation seen as Hyperintense signal in T2-weighted image.|Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks)|Full Analysis Population included all enrolled randomized patients.|||percentage of participants||95% Confidence Interval|Number
1390146|NCT01355627|Primary|Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure|An assessment was performed daily from randomization to Day of Discharge and at the Efficacy Follow-up visit at week 7 ± 1 week. Clinically evident cerebrospinal fluid leak was confirmed by: 1. Glucose concentration test and/or 2. β-2-transferrin test. A clinically evident pseudomeningocele was considered to be present post-operatively if the following criteria were fulfilled: 1. A subcutaneous, visible/palpable fluctuant fluid accumulation was noted at the site of the surgical incision or adjacent to it; 2. It is suspected the fluid accumulation is cerebrospinal fluid. A treatment failure was defined as application of a new and/or different treatment after application of the study treatment or a third application of (or part of) the selected study treatment on the outside of the dura.|Up to 8 Weeks (7 Weeks ± 1 Week)|Full Analysis Population included all enrolled randomized patients.|||percentage of participants||95% Confidence Interval|Number
1390147|NCT01355588|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||hours||Full Range|Median
1390148|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||ng*h/mL||Standard Deviation|Mean
1390149|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||ng*h/mL||Standard Deviation|Mean
1390150|NCT01355588|Primary|Maximum Observed Plasma Concentration (Cmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||ng/mL||Standard Deviation|Mean
1390183|NCT01355289|Secondary|Number of Participants Who Initiated Antiviral Treatment by Day 21 of Period A1 of Core Study|Blood draws were taken to monitor platelet counts during the first 21 days of study treatment. When a platelet count of greater than or equal to 100 X 10^9/L was attained, antiviral treatment was initiated.|Baseline to Day 21|Full analysis set (FAS), the group of all randomized participants of core study.|||Participants|||Count of Participants
1390151|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 10 Weeks Postoperatively|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.~Units of measure = % of patients with YES to POCD"|App. 10 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 10 weeks postoperatively.|||Percentage of patients|||Number
1390152|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 2 Weeks Postoperatively.|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.~Units of measure = % of patients with YES to POCD"|App. 2 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 2 weeks postoperatively.|||Percentage of patients|||Number
1390153|NCT01355523|Secondary|HPER3 Genotype|A blood sample will be taken at inclusion and analysed for HPER3 genotype (4/4, 4/5, 5/5) and this will be investigated for a correlation with sleep, cognitive function and depressive symptoms 7 patients did not give blood samples|At inclusion = day-7||||Participants|||Number
1390154|NCT01355523|Secondary|Sleep Architecture|Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph will be worn from inclusion till 14 days postoperatively.|From inclusion till 14 days postoperatively|||||||
1390155|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Long-term Postoperative Period|"Subjective sleep on a Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
1390156|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Immediate Postoperative Period|"Subjective sleep score on Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
1390157|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Long-term Postoperative Period|"Pain on a Visual Analog Scale - filled out every 14th day. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
1390158|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Immediate Postoperative Period|"Pain on a Visual Analog Scale - filled out daily. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
1390159|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on General Well-being - Long-term Postoperative Period|"General well-being on a Visual Analog Scale - filled out every 14th day. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
1390160|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on General Well-being - Immediate Postoperative Period|"General well-being on a Visual Analog Scale - filled out daily. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|Patients were only included in the analysis if they had completed daily VAS on anxiety for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward.|||mm*day||Inter-Quartile Range|Median
1390161|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Long-term Postoperative Period|"Fatigue on a Visual Analog Scale - filled out every 14th day. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
1390162|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Immediate Postoperative Period|"Fatigue on a Visual Analog Scale - filled out daily. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
1390163|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Long-term Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||Units on KSS*2 weeks||Inter-Quartile Range|Median
1390164|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Immediate Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||Units on KSS*day||Inter-Quartile Range|Median
1390165|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Long-term Postoperative Period|"Anxiety measured by VAS (visual analog scale). Completed every 14th day. A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|Patients were only included in the analysis if they had completed VAS on anxiety in the long-term postoperative period. Single missing data were filled out using last observation carried forward.|||mm*2 weeks||Inter-Quartile Range|Median
1390166|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Immediate Postoperative Period|"Anxiety measured by VAS (visual analog scale). A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily - from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
1390167|NCT01355523|Primary|Intention to Treat (Overestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as “YES” for depression."|Intention to treat (overestimate) - depression at one point in the study period (not baseline)|"All missing data have been analyzed as YES depression."|||participants|||Number
1390168|NCT01355523|Primary|Intention to Treat (Underestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as “NO” depression."|Intention to treat (underestimate) - depression at one point in the study period (not baseline)|"All missing MDI data have been analyzed as NO depression."|||participants|||Number
1390169|NCT01355523|Primary|Per Protocol - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 This analysis includes only patients who have taken study medication as planned."|Per protocol - depression at one point in the study period (not baseline)|Includes only patients who have taken the study medication as planned|||participants|||Number
1390170|NCT01355523|Primary|Major Depression Inventory (MDI)- Depression at One Point in the Study|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Diagnostic scale using the ICD-10 algorithm:~Mild depression: 2 core symptoms and 2 other symptoms Moderate depression: 2 core symptoms and 4 other symptoms Severe depression: 3 core symptoms and 5 other symptoms~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50"|Depression at one point in the study (not including baseline) out of 4 measurements at app. day 21, day 35, day 63 and day 91 of the study.|Includes all patients who have completed at least one other MDI than baseline|||participants|||Number
1390171|NCT01355484|Primary|Lean Body Mass|Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.|Day 84|Subjects included in the Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
1390172|NCT01355484|Primary|Physical Function|Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.|Day 84|Subjects included in the Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
1390173|NCT01355471|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population(i.e. Hours 3,6,9,12)|||participants|||Number
1390174|NCT01355458|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12)|||participants|||Number
1390175|NCT01355419|Secondary|Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients|Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy|baseline and at 3 months||||steps||Standard Deviation|Mean
1390176|NCT01355419|Primary|Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients|change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy|baseline and at 3 months||||minutes||Standard Deviation|Mean
1390177|NCT01355302|Secondary|Time to Progression (TTP)|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|Until disease progression or death for 3 years|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.||||||
1390178|NCT01355302|Secondary|Overall Response Rate (ORR)|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|Until disease progression or death for 3 years|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.||||||
1390179|NCT01355302|Primary|Time to Maximum Concentration (Tmax) of Golvatinib|Tmax was defined as the time at which Cmax was observed for golvatinib in combination with cisplatin and capecitabine.|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.|||Hours||Full Range|Median
1390180|NCT01355302|Primary|Number of Participants With a Treatment-Emergent Adverse Event (TEAE)|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious AEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. A TEAE was defined as an adverse event (AE) that had an onset date, or a worsening in severity from Baseline (pretreatment), on or after the first dose of study drug up to 30 days after the date of last study treatment.|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month.|Safety Population included all participants who received at least one dose of study drug and who had at least one safety assessment after the first dose of study drug.|||Participants|||Number
1390181|NCT01355302|Primary|Maximum Concentration (Cmax) of Golvatinib|Blood samples were drawn to analyze the amount of golvatinib in the participant's serum. Maximum concentration refers to the maximum (or peak) serum concentration of study drug in the participant's system after administration of the study drug and prior to the administration of a second dose of the study drug. Results were expressed in nanograms/milliliter (ng/mL).|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.|||ng/mL||Full Range|Median
1390182|NCT01355302|Primary|Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib|On days when pharmacokinetic (PK) samples were to be drawn, a predose blood sample was obtained prior to administration of golvatinib and capecitabine. After administration of study drugs, a second postdose blood sample was taken. The amount of golvatinib in the participant's blood was analyzed and the AUC was calculated. The AUC reflects the actual body exposure to drug after administration of a dose of the drug and is dependent on the rate of elimination of the drug from the body and the dose administered. Predose samples that were below the limit of quantitation (BLQ) or missing were assigned a numerical value of zero for the calculation of AUC. Any other BLQ concentrations were assigned a value of zero. Results were expressed in nanograms·hour/milliter (ng·h/mL).|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.|||ng·h/mL||Full Range|Median
1390184|NCT01355289|Primary|Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study|A responder was defined as a participant having a platelet count of greater than or equal to 100x10^9/L by Day 21 starting from an average baseline platelet count of greater than 20 x 10^9/L to less than or equal to 70 x 10^9/L.|Baseline to Day 21|Full analysis set (FAS), the group of all randomized participants of core study.|||Participants|||Count of Participants
1390185|NCT01355289|Secondary|Number of Participants Who Achieved Platelet Count Greater Than 30 X 10^9/L From Baseline to Day 21 During Treatment Period A1 of Core Study|Blood draws were taken to monitor platelet counts.|Baseline to Day 21|Full analysis set (FAS), the group of all randomized participants of core study.|||Participants|||Count of Participants
1390186|NCT01355289|Secondary|Change From Baseline of Local Platelet Count by Visit During Treatment Period A1 of Core Study|Missing platelet counts were imputed using last observation carried forward (LOCF) approach for subjects who achieved platelet response at prior visits.|Day 7 and Day 14|Full analysis set (FAS), the group of all randomized participants of core study.|||cells x 10^9/L||Standard Deviation|Mean
1390187|NCT01355224|Primary|Intention to Lose Weight - Combined Risk|Intention to lose 10lbs in the next 6 months on a 5-point likert scale (1-strongly disagree; 5-strongly agree). This was examined by study arm and by combined levels of feedback (e.g. elevated genetic risk and non-elevated lifestyle risk)|3 months from viewing obesity risk assessment||||units on a scale||95% Confidence Interval|Mean
1390188|NCT01355224|Primary|Intention to Lose Weight - Impact of Risk Status|Intention to lose 10lbs in the next 6 months measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). This was examined by study arm and level of feedback received (high or elevated risk vs low or non-elevated risk).|3 months after viewing obesity risk assessment||||units on a scale||95% Confidence Interval|Mean
1390189|NCT01355224|Primary|Intentions to Lose Weight - Effect of Study Arm on Outcomes|Intention to lose 10lbs in the next 6 months was measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). Responses were examined by study arm.|3 months after viewing obesity risk assessment||||units on a scale||95% Confidence Interval|Mean
1390190|NCT01355081|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment|The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Error|Least Squares Mean
1390191|NCT01355081|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate."|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Error|Least Squares Mean
1390192|NCT01355081|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment|The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward.|||scores on a scale||Standard Error|Least Squares Mean
1390193|NCT01355081|Secondary|Percentage of Patients With MADRS Remission After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.|Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.|||percentage of participants|||Number
1390194|NCT01355081|Secondary|Percentage of Patients With MADRS Response After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.|||percentage of participants|||Number
1394119|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1390195|NCT01355081|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug; who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last observation carried forward.|||scores on a scale||Standard Error|Least Squares Mean
1390196|NCT01355068|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1390197|NCT01355068|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||hr||Standard Deviation|Mean
1390198|NCT01355068|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrap)|AUC%extrap is the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as (AUC [0-∞] minus AUClast)*100/ AUC [0-∞], where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Percent AUC||Standard Deviation|Geometric Mean
1390199|NCT01355068|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
1390200|NCT01355068|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1390201|NCT01355068|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1390202|NCT01354990|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months||||participants|||Number
1390203|NCT01354990|Primary|Number of Participants With Concomitant Therapies||Up to approximately 28 months||||participants|||Number
1390204|NCT01354990|Primary|Age of Participants Prescribed Sitagliptin||Up to approximately 28 months||||years||Standard Deviation|Mean
1390205|NCT01354990|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months||||participants|||Number
1390206|NCT01354938|Primary|Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. The change from Baseline of 4 or more units lower, consistent with a clinically significant change in the participant, was considered in this study to be the ‘minimal clinically important difference’ (MCID).|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data|||participants|||Number
1390207|NCT01354938|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|AE=any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. SAE=an event meeting any of the following criteria: results in death, hospitalization, prolongation of hospitalization, is life-threatening, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention, spontaneous or elective abortion. AEs and SAEs were collected during the course of the study. See the Reported Adverse Event section for details.|From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)|All enrolled participants|||participants|||Number
1390229|NCT01354314|Secondary|Neurocognitive Performance: Timed Gait - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390314|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1390208|NCT01354938|Primary|St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the participant.|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data|||units on a scale||Standard Deviation|Mean
1390209|NCT01354899|Secondary|Overall Experience of Use of the Dressing|Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent|During 5 days||||participants|||Number
1390210|NCT01354899|Primary|Erythema (No/Yes)|Measure number of skin breakdown during from enrolment to termination.|During 5 days||||participants|||Number
1390211|NCT01354652|Secondary|Overall OLT-free Survival|Overall OLT-free survival until development of OLT and death and participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months|Participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months||||day||Standard Deviation|Mean
1390212|NCT01354652|Secondary|Arterial pH and Anion Gap in Cases With Elevated Blood Lactate Levels (at the Time of Detection and Peak Levels|Arterial pH and anion gap in cases with elevated blood lactate levels (at the time of detection and peak levels until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
1390213|NCT01354652|Secondary|Frequency of Concomitant Prescribed Medications Possibly Associated With Lactic Acidosis Other Than NTRIs|Frequency of concomitant prescribed medications possibly associated with lactic acidosis other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
1390214|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Caused by Etiologies Other Than NTRIs|incidence of elevated venous lactate levels more than 2 mmol/L caused by etiologies other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
1390215|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Directly Related to NRTI|incidence of elevated venous lactate levels more than 2 mmol/L directly related to NRTI until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
1390216|NCT01354652|Primary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L of Any Etiology|incidence of elevated venous lactate levels more than 2 mmol/L of any etiology until development of lactic acidosis, orthotropic liver transplantation (OLT), death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Our study was terminated early with only 5 participant enrolled. We gained lactic acid levels for the 5 patients (all elevated), however we considered that it was not sufficient to be analyzed. Morover, we did not further investigate the etiology for elevated lactic acid levels and secondary etiology-based outcomes are not recorded here.|||participants|||Number
1390217|NCT01354444|Secondary|Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers|The investigators will measure CSF Abeta oligomer levels before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing the change in levels in 6 AD participants taking carvedilol vs. 10 AD participants taking placebo. These 16 participants had both baseline and 6 month CSF collected (of the entire study population).|6 months||||ng/mL||Standard Deviation|Mean
1390218|NCT01354444|Secondary|Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers|The investigators will measure CSF Abeta oligomer levels before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing the change in levels in 6 AD participants taking carvedilol vs. 10 AD participants taking placebo. These 16 participants had both baseline and 6 month CSF collected (of the entire study population). CSF was collected at the baseline visit and 6 months later.|6 months||||pg/mL||Standard Deviation|Mean
1390219|NCT01354444|Primary|Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months|The investigators measured episodic memory (as evidence by the Hopkins Verbal Learning Test (HVLT)) before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily. Changes in HVLT Immediate and Delayed Recall score in 14 Alzheimer's Disease (AD) participants taking carvedilol vs. 15 AD participants taking placebo were compared. HVLT test score ranges are as follows: immediate recall (0-24) delayed recall (0-12). Higher scores indicate better episodic memory recall.|Baseline, 3 months, and 6 months||||Scores on a scale||Standard Deviation|Mean
1390230|NCT01354314|Secondary|Neurocognitive Performance: Timed Gait - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390220|NCT01354431|Secondary|Median Progression Free Survival (PFS) in Months at Interim Data Cut-off - Randomized Population|PFS: the time from randomization to the date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) was measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Participants were censored if they had not experienced disease progression (they were still on treatment or in follow-up) or had received subsequent cancer therapy. Disease Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to March 2015 data cut off. Study on-going.|||Months||80% Confidence Interval|Median
1390221|NCT01354431|Secondary|Median Overall Survival in Months at Interim Data Cut-off - Randomized Population|Median Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to interim data cut off, March 2015. Study on-going.|||Months||80% Confidence Interval|Median
1390222|NCT01354431|Secondary|Number of Participants With Best Overall Response at Primary Endpoint - Randomized Population|Best response defined as the best response across all time points. Primary endpoint=116 events, approximately 2 years. Tumor response was evaluated by investigator according to RECIST version 1.1. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; partial response (PR): at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease Progression (PD) was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions; Stable disease: neither shrinkage to qualify for PR or increase to qualify for PD.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All Randomized participants were summarized up to Primary endpoint data cut off, approximately 2 years.|||participants|||Number
1390223|NCT01354431|Secondary|Objective Response Rate (ORR) at Primary Endpoint- Randomized Population|Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate (ORR) was defined as the number of responders divided by the number of randomized participants; Responders=complete response (CR) or partial response (PR). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR was estimated along with exact 80% Confidence Interval (CI) using the Clopper and Pearson method.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All randomized participants were analyzed up to Primary endpoint, approximately 2 years.|||percentage of participants||80% Confidence Interval|Number
1390224|NCT01354431|Primary|Median Progression Free Survival (PFS) at Primary Endpoint - Randomized Population|PFS: time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) and measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator’s assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All participants who were randomized to a treatment arm.|||Months||80% Confidence Interval|Median
1390225|NCT01354314|Secondary|Change in CES-D Score - Per Protocol|Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (per protocol).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||units on a scale||Standard Deviation|Mean
1390226|NCT01354314|Secondary|Change in CES-D Score - Intent to Treat|Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (intent to treat analysis).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||units on a scale||Standard Deviation|Mean
1390227|NCT01354314|Secondary|Neurocognitive Performance: NPZ-8 - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390228|NCT01354314|Secondary|Neurocognitive Performance: NPZ-8 - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390231|NCT01354314|Secondary|Neurocognitive Performance: Symbol-Digit Test - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available (no data substitution) at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390232|NCT01354314|Secondary|Neurocognitive Performance: Symbol-Digit Test - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).|24 Weeks|Includes all participants who completed the study with test data available (no data substitution) at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390233|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Sequential - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390234|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Sequential - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390235|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Choice - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390236|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Choice - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390237|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390238|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390239|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Dominant - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390240|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Dominant - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390241|NCT01354314|Secondary|Neurocognitive Performance: Trail Making B - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390242|NCT01354314|Secondary|Neurocognitive Performance: Trail Making B - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390243|NCT01354314|Secondary|Neurocognitive Performance: Trail Making A - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
1390244|NCT01354314|Secondary|Neurocognitive Performance: Trail Making A - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
1390245|NCT01354314|Secondary|Change in CSF Neurofilament Protein Heavy Chain (pNFH) Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFH) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
1390246|NCT01354314|Secondary|Change in CSF Neurofilament Protein Heavy Chain (pNFL) Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
1390536|NCT01352221|Secondary|Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)|ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|Baseline to Week 4 - double-blind phase||||g/dL||Standard Deviation|Mean
1390247|NCT01354314|Secondary|Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
1390248|NCT01354314|Secondary|Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
1390249|NCT01354314|Secondary|Change in CSF CD163 Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
1390250|NCT01354314|Secondary|Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
1390251|NCT01354314|Secondary|Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
1390252|NCT01354314|Secondary|Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
1390253|NCT01354314|Primary|Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol|CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for participants with 90% or greater adherence to study drug and for whom CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the total 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pi*mm^2||Inter-Quartile Range|Median
1390254|NCT01354314|Primary|Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat|CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for all participants for whom CSF data are available (intent to treat analysis).|24 Weeks|For intention to treat analysis, 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pi*mm^2||Inter-Quartile Range|Median
1390255|NCT01354314|Primary|Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol|CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
1390256|NCT01354314|Primary|Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat|CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
1390257|NCT01354223|Secondary|Evaluation of Average Lens Wearing Time - Average Daily Hours Worn|The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||hours||Standard Deviation|Mean
1390258|NCT01354223|Primary|Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better|"The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B.~Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared."|week 1 visit, week 2 visit, month 1 visit, month 2 visit combined|For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.|||percentage of possible examinations|Participants||Number
1390271|NCT01354145|Secondary|Percentage of Participants With the Presence of Extrusion in the Meniscus|The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||percentage of participants|||Number
1390259|NCT01354223|Secondary|Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort|"The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens.~Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3)."|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.|||percentage of eyes|Participants||Number
1390260|NCT01354223|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses.~The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit)."|Any occurrence from dispensing to month 3 visit|Unique eyes are defined as each individual eye in the study.|||number of adverse events|Participants||Number
1390261|NCT01354223|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses.~The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings|||units on a scale|Participants|Full Range|Mean
1390262|NCT01354197|Secondary|Readmission to ICU|Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU|3 days||||participants|||Number
1390263|NCT01354197|Primary|Overall Mortality|Number of Participants who Did Not Survive up to 28 days after surgical ICU admission|28 days||||participants|||Number
1390264|NCT01354145|Secondary|Use of Acetaminophen|"Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit.~Daily consumption of acetaminophen was calculated as an average."|3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728)|Intention-To-Treat|||Daily number of caplets taken||Standard Deviation|Mean
1390265|NCT01354145|Secondary|Percentage of Participants With Presence of Joint Swelling and Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and effusion.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||percentage of participants|||Number
1390266|NCT01354145|Secondary|Short Form (SF-36) Health Survey|"The SF-36 is composed of 35 items measuring:~8 health concepts (or dimensions), [(Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH)]~and 1 reported health transition item.~The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||Scores on a scales||Standard Deviation|Median
1390267|NCT01354145|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
1390268|NCT01354145|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
1390269|NCT01354145|Secondary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
1390270|NCT01354145|Secondary|Visual Analog Scale (VAS)|Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson’s VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: “Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line”. Left hand marker represents “No pain” and right hand marker represents “The worst pain imaginable”.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
1390273|NCT01354145|Secondary|Bone Marrow Lesions Score|"To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.~The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows:~Grade 0 = Absence of lesion in the sub region~Grade 1 = less than 25% of the surface~Grade 2 = 25-50% of the surface~Grade 3 = more than 50% of the surface"|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||units on a scale||Standard Deviation|Mean
1390274|NCT01354145|Secondary|Synovial Membrane Thickness|"To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.~The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||milimeters||Standard Deviation|Mean
1390275|NCT01354145|Secondary|Cartilage Volume in the Medial Compartment|To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||cubic milimeters||Standard Deviation|Mean
1390276|NCT01354145|Secondary|Cartilage Volume Loss of the Global Knee|To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-to-Treat|||cubic milimeters||Standard Deviation|Mean
1390277|NCT01354145|Primary|Cartilage Volume Loss of the Lateral Compartment|To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||cubic milimeters||Standard Deviation|Mean
1390278|NCT01354132|Secondary|Myo-Inositol Brain Level for Placebo Group|Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1390279|NCT01354132|Secondary|Myo-Inositol Brain Level for the NAC Group|Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1390280|NCT01354132|Secondary|Glutathione Brain Level for Placebo Group|measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1390281|NCT01354132|Secondary|Glutathione Brain Level for NAC Group|measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1390282|NCT01354132|Secondary|Glutamate Brain Level for Placebo Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1390283|NCT01354132|Secondary|Glutamate Brain Level for NAC Group|Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1390284|NCT01354132|Secondary|Glutamine Brain Level for Placebo Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1390285|NCT01354132|Secondary|Glutamine Brain Level for NAC Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
1405547|NCT01216397|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|Geometric mean of Cmax of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1390288|NCT01354132|Secondary|Change in Blood Level of Glutathione|Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells.|at 6 months||||mM||Standard Deviation|Mean
1390289|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving|The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
1390290|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Visual Learning|The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
1390291|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Verbal Learning|The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
1390292|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Attention and Vigilance|The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
1390293|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Working Memory|The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
1390294|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Speed of Processing|The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
1390358|NCT01353508|Secondary|Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker|BNP was analyzed at a central laboratory.|0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390295|NCT01354132|Secondary|Social and Occupational Functioning Assessment Scale (SOFAS)|"Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10:~100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others"|at 6 months||||units on a scale||Standard Deviation|Mean
1390296|NCT01354132|Secondary|Global Assessment of Functioning (GAF)|"Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10:~100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others"|at 6 months||||units on a scale||Standard Deviation|Mean
1390297|NCT01354132|Secondary|Change in Positive Symptoms (PANSS)|"Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week:~RATING SCALE~1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ."|at 6 months|Analysis was done with participants who completed the 6 month treatment phase|||units on a scale||Standard Deviation|Mean
1390298|NCT01354132|Primary|Change in Negative Symptoms of Schizophrenia as Measured on the PANSS|"Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week:~RATING SCALE~1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ."|at 6 months|Analysis was done with those who completed the 6 month treatment protocol.|||units on a scale||Standard Deviation|Mean
1390299|NCT01354106|Primary|Skin Trauma|"Expert grader using Erythema/Edema Scale 0=No visible response~mild response~moderate response~severe response~extreme response"|24 hours||||Units on a scale||Standard Deviation|Mean
1390300|NCT01354028|Primary|Number of Infants Sleeping at the End of the Massage Period|Investigators compared the number of infants sleeping at the end of the massage period with the percentage of infants sleeping at the same time on the non massage day.|Minute massage ended|A convenient number of infants was determined for this pilot study|||participants|||Number
1390301|NCT01354028|Secondary|Heart Rate|Heart rate during massage therapy|During massage therapy|A convenient size was determined for this pilot study|||beats per minute||Standard Deviation|Mean
1390302|NCT01354028|Secondary|Oxygen Saturation Levels During Massage|Infants in the NICU are routinely attached to pulse oximeter monitors that measure oxygen saturation continuously. If the infant is stressed, oxygen levels may drop. Oxygen saturation was monitored during massage therapy as a routine measure but also to ensure that infants did not become stressed during the massage.|During massage|We determined a convenient size for this pilot study|||percentage of oxygen saturation||Standard Deviation|Mean
1390303|NCT01354028|Primary|Quality of Sleep, Defined by Number and Duration of Awakenings, and Longest Sustained Sleep Period for the Study Interval. These Data Were Measured by the Actigraph Software and Summarized as Percentage of Time Spent Sleeping, or Sleep Efficiency|Sleep onset following the first quiet alert state after the 9 AM feed Sleep end time Number of awakenings and duration of the awakenings during the study period Longest sustained sleep period for the study interval Percentage of time spent sleeping, or sleep efficiency, will be used to summarize the data, comparing sleep efficiency over 2 days and using each infant as his/her own control|Participants were followed for two days|A convenient number of participants was selected for this pilot study.|||percentage of time spent sleeping||Standard Deviation|Mean
1390304|NCT01354015|Secondary|Change in HbA1c Over 3 Months|Change in HbA1c|baseline to 3 months|Of the 50 enrolled in the Use of DRMS group, only 46 completed the visit at 3 months, and out of 48 enrolled in the Usual Care group only 45 completed the visit at 3 months. Therefore only those who completed the visit at 3 months were included in this analysis.|||Percent||Standard Deviation|Mean
1390305|NCT01354015|Primary|Change in HbA1c|change in A1c from baseline in intervention and control groups|baseline to 6 months|Of the 50 enrolled in the Use of DRMS group, only 44 completed the visit at 6 months, and out of 48 enrolled in the Usual Care group only 43 completed the visit at 6 months. Therefore only those who completed the visit at 6 months were included in this analysis.|||Percent||Standard Deviation|Mean
1390306|NCT01353976|Secondary|Mycological Cure|Mycological Cure defined as negative KOH and negative culture at Day 43.|Day 43|MITT|||Participants|||Number
1390307|NCT01353976|Secondary|Effective Treatment|Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43.|Day 43|MITT|||Participants|||Number
1390308|NCT01353976|Primary|Complete Cure|Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.|Day 43|MITT|||Participants|||Number
1390309|NCT01353963|Primary|Change From Baseline in Weight at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||kg||Standard Deviation|Mean
1390310|NCT01353963|Primary|Change From Baseline in Weight at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||kilogram (kg)||Standard Deviation|Mean
1390311|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||bpm||Standard Deviation|Mean
1390315|NCT01353963|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.|Week 4 to Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||Participants|||Number
1390316|NCT01353911|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 72|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 72|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
1390317|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (TND) HCV RNA at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after the end of all treatment (up to 72 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
1390318|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (TND) HCV RNA at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after the end of all treatment (up to 60 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
1390319|NCT01353911|Secondary|Percentage of Participants Achieving Rapid Viral Response (RVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). RVR was defined as undetectable (TND) HCV RNA at Week 4 of study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|After 4 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
1390320|NCT01353911|Secondary|Median Time to First Achievement of Undetectable HCV RNA During Treatment|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 48 weeks of treatment)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens. Participants in the FAS not achieving TND were censored.|||days||95% Confidence Interval|Median
1390321|NCT01353911|Primary|Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|APaT population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||participants|||Number
1390359|NCT01353508|Secondary|Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker|MR-proANP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390322|NCT01353911|Primary|Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|All Participants as Treated (APaT) population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||participants|||Number
1390323|NCT01353911|Primary|Percentage of Participants Achieving Complete Early Viral Response (cEVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). cEVR was defined as undetectable HCV RNA (target not detected [TND]) at Week 12. 95% confidence intervals provided based on the Clopper-Pearson method.|After 12 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
1390324|NCT01353898|Primary|Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo|Blood was collected at baseline and on Day 10, and the plasma concentration for HIV-1 RNA was determined using the Abbott RealTime HIV assay.|Baseline and Day 10 (24 hours post-dose)|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||log10 copies/mL||Standard Error|Mean
1390325|NCT01353898|Secondary|The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection|Plasma concentration of MK-1972 was determined from blood collected from HIV-1 infected participants on Day 10 : pre-dose up to 24 hours post-dose in order to determine the AUC0-24hrs.|Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. MK-1972 was not measured for the placebo group since it did not receive any of this drug.|||nM.hr||Geometric Coefficient of Variation|Geometric Mean
1390326|NCT01353898|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an adverse event.|From consent to 14 days after the last dose (up to Day 24)|All participants who received at least one dose of the investigational drug, according to the treatment they actually received.|||Participants|||Number
1390327|NCT01353859|Secondary|C-Reactive Protein Levels|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Baseline, Weeks 4, 8, 12,16, 20, and 24|ITT Population|||mg/L||Standard Deviation|Mean
1390328|NCT01353859|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation rate was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm/hr||Standard Deviation|Mean
1390329|NCT01353859|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response|ACR20/50/70 response was defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) as well as improvement in at least 3 of the 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the health assessment questionnaire [HAQ]); and acute phase response: C-reactive protein (CRP) or ESR.|Week 24|ITT Population|||percentage of participants|||Number
1390330|NCT01353859|Secondary|Percentage of Participants With DAS28 <3.2 by Visit|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
1390331|NCT01353859|Secondary|Time to Achieve DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 remission was defined as DAS28 <2.6. Time to achieve remission was calculated in weeks as the time from the date of first infusion to the date of first achieving remission.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population|||weeks||Standard Deviation|Mean
1390332|NCT01353859|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Remission was defined as DAS28 <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
1390333|NCT01353859|Secondary|Time to Clinically Significant Improvement in DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement is a reduction in DAS28 score of at least 1.2 units. Time to clinically significant improvement was determined in weeks from the date of first infusion to the date of first achievement of reduction of 1.2 units in DAS28.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population|||weeks||Standard Deviation|Mean
1390334|NCT01353859|Secondary|Percentage of Participants With a Clinically Significant Improvement in DAS28 Score|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement in DAS28 score was defined as a reduction of at least 1.2 units.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population|||percentage of participants|||Number
1390335|NCT01353859|Secondary|Time to Achieve Low Disease Activity (DAS28 ≤3.2)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity; time to low disease activity was calculated as the time in weeks from the date of first infusion to the first achievement of DAS28 ≤3.2|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||weeks||Standard Deviation|Mean
1390336|NCT01353859|Primary|Percentage of Participants Achieving Low Disease Activity Score|Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population: All participants randomized in the study who received administration of at least one dose of the study drug and who had the last week 24 assessment performed.|||percentage of participants|||Number
1390337|NCT01353664|Primary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days|Safety Population = Participants who received at least one dose of study drug.|||Participants|||Number
1390338|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation|All SNA subjects were to be evaluated by expert neurologists for existing neurological deficits prior to ablation procedure. After procedure, those subjects were also to be assessed for new neurological deficits.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.|||percentage of participants|||Number
1390339|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation|Evaluation of post-ablation generation incidence of asymptomatic cerebral microembolic lesions post ablation, as documented by MRI. All microembolic lesions reported in this study are asymptomatic.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.|||percentage of subjects with ACE Lesion|||Number
1390340|NCT01353586|Secondary|Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure|This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure.|6 and12 months post study procedure|This analysis population is the effectiveness cohort, excluding 2 subjects who withdrew consent prior to Day 91. The effectiveness cohort includes those who received treatment with the investigational device; but does not include 20 workflow and 22 roll-in subjects.|||percentage of participants||95% Confidence Interval|Number
1390341|NCT01353586|Secondary|Incidence of Completion of Ablation Procedure|This secondary outcome describes the acute effectiveness, which is defined as pulmonary vein isolation (PVI) documented by confirmed entrance block (with or without the use of a focal catheter).|From 7 days to 12 months post study procedure|Safety population excluding one subject without source document at site|||percentage of participants||95% Confidence Interval|Number
1390342|NCT01353586|Secondary|Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation|Incidence of narrowing of PV and stenosis at 3 months post ablation, for subjects with available CT/MRA scans at 3 months. PV Stenosis is defined as 70% or more PV diameter reduction.|Three months after index ablation|Subjects in safety analysis group who also had CT/MRI PV scan available at the 3-month post-ablation interval (144 of 160 subjects)|||percentage of participants with CT/MRI|||Number
1390343|NCT01353586|Secondary|Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months|This secondary safety endpoint includes non-primary serious adverse events within 7 days post-procedure and serious adverse events from 7 days to 12 months post-procedure.|12 months post study procedure|Safety population|||percentage of participants|||Number
1390691|NCT01350258|Primary|Phase 2: Non-Relapse Mortality (NRM)|To evaluate the 100 day non-relapse mortality (NRM) rate in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|100 days post-treatment|||||||
1390344|NCT01353586|Primary|Incidence of Freedom From Documented Symptomatic Atrial Fibrillation|The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.|Evaluated from Day 91 to Day 240|Effectiveness cohort: This population excludes those subjects who never underwent insertion of study catheter, those who terminated procedure prior to ablation, and those who were enrolled during the Workflow phase (20 subjects) and Roll-in phase (22 subjects). This analysis also excludes two subjects who withdrew consent post ablation.|||percentage of participants||95% Confidence Interval|Number
1390345|NCT01353586|Primary|The Incidence of Early Onset Primary Adverse Events|The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Primary adverse events include pericardial effusion requiring intervention, atrial perforation, pericarditis requiring intervention, cardiac tamponade, pneumothorax, death, pulmonary edema, diaphragmatic paralysis, heart block, stroke / cerebrovascular accident (CVA), hospitalization (initial and prolonged), thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), and vascular access complications. In addition, pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure are deemed primary adverse event.|Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure)|Safety Population as defined above|||percentage of participants||95% Confidence Interval|Number
1390346|NCT01353508|Secondary|Supine Pulse Rate|Pulse rate measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||BPM||Standard Deviation|Mean
1390347|NCT01353508|Secondary|Supine Diastolic Blood Pressure|Diastolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmHg||Standard Deviation|Mean
1390348|NCT01353508|Secondary|Supine Systolic Blood Pressure|Systolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmHg||Standard Deviation|Mean
1390349|NCT01353508|Secondary|Renal Blood Flow (RBF) Over Time|RBF was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL/min||Standard Deviation|Mean
1390350|NCT01353508|Secondary|Glomerular Filtration Rate (GFR) Over Time|GFR was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL/min||Standard Deviation|Mean
1390351|NCT01353508|Secondary|Percent Change From Baseline in Blood Plasma Creatinine|Blood plasma creatinine was analyzed at a central laboratory.|4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390352|NCT01353508|Secondary|Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390353|NCT01353508|Secondary|Percent Change From Baseline in Aldosterone Biomarker|Aldosterone was analyzed at a central laboratory.|6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390354|NCT01353508|Secondary|Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker|NT-proBNP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390355|NCT01353508|Secondary|Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker|CT-proET-1 was analyzed at a central laboratory.|12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390356|NCT01353508|Secondary|Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker|ProCNP was analyzed at a central laboratory.|2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390357|NCT01353508|Secondary|Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker|MR-proADM was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.|||Percentage change||95% Confidence Interval|Least Squares Mean
1390360|NCT01353508|Secondary|Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours|cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM.|day 1, day 6, day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||nmol/24 hours||95% Confidence Interval|Least Squares Mean
1390361|NCT01353508|Secondary|7-day Cumulative Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|7-day cumulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL||95% Confidence Interval|Least Squares Mean
1390362|NCT01353508|Secondary|24-hour Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL/24 hours||95% Confidence Interval|Least Squares Mean
1390363|NCT01353508|Primary|Cumulative 7-day Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|7 day-cummulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmol/7 days||95% Confidence Interval|Least Squares Mean
1390364|NCT01353508|Primary|24-hour Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmol/24 hours||95% Confidence Interval|Least Squares Mean
1390365|NCT01353274|Secondary|Proportion of Patients Who Normalised Their BP|Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||Percentage of patients (normalised BP)|||Number
1390366|NCT01353274|Secondary|Proportion of Patients Who Achieved the Target BP|Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||Percentage of patients (target BP)|||Number
1390367|NCT01353274|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||mmHg||Standard Deviation|Mean
1390368|NCT01353274|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg Fixed Dose Combination (FDC) and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||mmHg||Standard Deviation|Mean
1390369|NCT01353274|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 months|Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact|||participants|||Number
1390370|NCT01353222|Primary|Overall Survival|"Overall survival is defined as the time from randomization to death due to any cause.~*This study was terminated early due to administrative reasons."|Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)|"Intent to Treat (ITT) population.~*This study was terminated early due to administrative reasons."|||Months||Full Range|Median
1390371|NCT01353144|Secondary|Number of Participants Deveoping Peptic Ulcer Bleeding|Number of participants deveoping peptic ulcer bleeding during 8-week study period|8 weeks||||participants|||Number
1390372|NCT01353144|Primary|Number of Participants in Whom Peptic Ulcer Was Healed|Number of participants in whom peptic ulcer was healed at week 8|8 weeks||||participants|||Number
1390373|NCT01353079|Secondary|Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)|"Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS).~Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season."|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.|||Scores on a scale||Standard Deviation|Least Squares Mean
1390383|NCT01352845|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1||Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
1405548|NCT01216319|Secondary|Rate of Patient Satisfaction|Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.|12 months||||percentage of patients|||Number
1390374|NCT01353079|Secondary|Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)|Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.|2011 ragweed pollen season; 8/2011 - 10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement|||Scores on a scale||Standard Deviation|Least Squares Mean
1390375|NCT01353079|Secondary|Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)|Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.|||Scores on a scale||Standard Deviation|Least Squares Mean
1390376|NCT01353079|Primary|Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]|Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|2011 ragweed pollen season, 8/2011 -10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement|||Scores on a scale||Standard Deviation|Least Squares Mean
1390377|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
1390378|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.||||||
1390379|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Titer||95% Confidence Interval|Geometric Mean
1390380|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary endpoint ‘Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1’.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
1390381|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
1390382|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1||One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
1390398|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390384|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain. This outcome measure was planned to be analyzed for Group 1 only.|||Titers||95% Confidence Interval|Geometric Mean
1390385|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
1390386|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
1390387|NCT01352845|Primary|Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. Here, number of participants analyzed signifies subjects that were evaluable for this outcome measure.|||Days||Standard Deviation|Mean
1390388|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
1390389|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390390|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390391|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390392|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390393|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390394|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390395|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
1390396|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390397|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390692|NCT01350258|Primary|Phase 1: Defined Dose of Melphalan (MEL)|To define the dose of MEL required for the establishment of peripheral T cell tolerance with concomitant immune reconstitution.|100 days post-transplant|||||||
1390399|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390400|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390401|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390402|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
1390403|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390404|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390405|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390406|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390407|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390408|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390409|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
1390410|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390411|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390412|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390413|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
1390414|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
1405605|NCT01215942|Secondary|Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]||Baseline, 240 weeks|Zero participants analyzed. VAS data was not collected for analysis due to early termination of the study.||||||
1390415|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390416|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390417|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, 'N' signifies participants with known values reporting specific characteristic.|||Percentage of participants||95% Confidence Interval|Number
1390418|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.|||Percentage of participants||95% Confidence Interval|Number
1390419|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.|||Percentage of participants||95% Confidence Interval|Number
1390420|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
1390421|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390422|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
1390423|NCT01352845|Primary|Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1|Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1390424|NCT01352793|Secondary|Number of Days Participant Missed School or Work Due to Adverse Events (AEs)||Vaccination 1 up to 1 month after Vaccination 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||days||Full Range|Median
1390425|NCT01352793|Secondary|Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 minutes after Vaccination 1, 2, 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
1390426|NCT01352793|Secondary|Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
1390438|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Baseline Visit (Day 1)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
1390427|NCT01352793|Secondary|Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
1390428|NCT01352793|Secondary|Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
1390429|NCT01352793|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
1390430|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 3|Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).|||percentage of participants||95% Confidence Interval|Number
1390431|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 2|Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.|||percentage of participants||95% Confidence Interval|Number
1390432|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 1|Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.|||percentage of participants||95% Confidence Interval|Number
1390433|NCT01352793|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study|An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Vaccination 1 up to 6 months after Vaccination 3|Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
1390434|NCT01352741|Secondary|Double-blind Comparative Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~“How would you rate your overall satisfaction with your current pain treatment?”: Excellent, Very Good, Good, Fair and Poor."|End of Comparative Period at Final Evaluation Visit (Day 77)|Last Observation Carried Forward (LOCF); Per Protocol Set|||participants|||Number
1390435|NCT01352741|Secondary|Open-label Titration Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~“How would you rate your overall satisfaction with your current pain treatment?”: Excellent, Very Good, Good, Fair and Poor."|End of Open-label Titration Period at Randomization Visit (Day 22)|Last Observation Carried Forward (LOCF); Per Protocol Set|||participants|||Number
1390436|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Randomization Visit (Day 22) to Final Evaluation (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
1390437|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
1390439|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
1390440|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||participants|||Number
1390441|NCT01352741|Secondary|Double-blind Comparative Period: Sleep Evaluation Questionnaire - Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline Visit (Day -12); Randomization Visit (Day 1); Final Evaluation Visit (Day 77)|Per Protocol Set.|||hours||Standard Deviation|Mean
1390442|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Hours Slept in the Double-blind Comparative Period Population|"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).|||hours||Standard Deviation|Mean
1390443|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Time Slept|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~The participant was asked: How long did you sleep last night? [Answered in hours and minutes]."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||hours||Standard Deviation|Mean
1390444|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Number of Awakenings|The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings. Participants were asked: How many times did you wake up during the night? The change in the Number of Awakenings was calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Final Evaluation Visit (Day 77). A negative change indicates that the number of awakenings in a treatment group have gone down since the Baseline or Randomization Visit. In general pain can interfere with sleep, one potential indicator is the number of awakenings.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).|||Number of Awakenings||Standard Deviation|Mean
1390445|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation - Number of Awakenings in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||Number of Awakenings||Standard Deviation|Mean
1390446|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Number of Awakenings|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||Number of Awakenings||Standard Deviation|Mean
1390447|NCT01352741|Secondary|Double-blind Comparative Period Sleep Evaluation Questionnaire: Change in Latency|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).|||hours||Standard Deviation|Mean
1390448|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Latency in the Double-blind Comparative Period Population|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. Sleep evaluation questionnaire (SQ) items|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).|||hours||Standard Deviation|Mean
1390449|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire – Latency|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the sleep latency.~To assess latency the participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||hours||Standard Deviation|Mean
1390493|NCT01352585|Secondary|Number of Patients With Platelet Count ≤400x10^9/L After 12 Months|A platelet count of ≤400x10^9/L after 12 months is considered a complete response.|1 year|FAS|||participants|||Number
1390450|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390451|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind Comparative Population; Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390452|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390453|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390454|NCT01352741|Secondary|Double-blind Comparative Period: Clinician Global Impression of Change (CGIC)|"In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Full Analysis Set (FAS).|||participants|||Number
1390455|NCT01352741|Secondary|Double-blind Comparative Period: Patient Global Impression of Change (PGIC)|"In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale where the patient's rates overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-blind comparative population. Full Analysis Set (FAS).|||participants|||Number
1390456|NCT01352741|Secondary|Double-blind Comparative Period: Change EuroQol-5 Dimension (EQ-5D) Health Status Index|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390457|NCT01352741|Secondary|Open-label Titration Period: EuroQol-5 Dimension (EQ-5D) Health Status Index Score for the Double-blind Comparative Period Population|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390458|NCT01352741|Secondary|Double-blind Comparative Period: Change in Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390459|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390460|NCT01352741|Secondary|Double-blind Comparative Period: Changes in the Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical summary scores were calculated from the individual responses to those questions covering physical health. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390461|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390462|NCT01352741|Secondary|Double-blind Comparative Period: Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. Spontaneous Pressing Pain Subscore). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 10 (100 for the overall score) . A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390463|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment in the Double-blind Comparative Period Population|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390464|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
1390465|NCT01352741|Secondary|Double-blind Comparative Period: Change in painDETECT Final Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 19. A negative change indicated a decrease in their neuropathic component of pain."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390466|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population painDETECT Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390467|NCT01352741|Secondary|Open-label Titration Period: painDETECT Assessments|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
1390468|NCT01352741|Secondary|Double-blind Comparative Period: Change in Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit.~A negative change indicates that the pain intensity decreased from the start of the trial."|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390469|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric Rating Scale (NRS), where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked : Please rate your pain intensity by assessing the one number that best describes your worst pain during the past 24 hours prior to the visit."|Enrollment Visit (Day-12); Baseline Visit (day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS)|||units on a scale||Standard Deviation|Mean
1390470|NCT01352741|Secondary|Open-label Titration Period: Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit."|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
1390471|NCT01352741|Secondary|Double-blind Comparative Period: Change in NRS-3 Pain Intensity Score for the Radiating Pain|"NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot).~The value reported represents the change from the randomization visit (i.e., the last 3 days in the titration period) to the end of the double-blind comparative period (i.e., the last 3 days in the comparative period). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit)."|Randomization Visit (Day 22); End of Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390472|NCT01352741|Secondary|Open-label Titration Period: Radiating Mean Pain Intensity Score for the Comparative Period Population|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390473|NCT01352741|Secondary|Open-label Titration Period: Radiating Pain|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
1390474|NCT01352741|Secondary|End of Open-label Pick-up Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Final Evaluation Visit (Day 77)|Observed.|||units on a scale||Standard Deviation|Mean
1390475|NCT01352741|Secondary|Open-label Continuation Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Observed values.|||units on a scale||Standard Deviation|Mean
1390476|NCT01352741|Secondary|Open-label Titration Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. Where 0 = no pain and 10 indicates pain as bad as you can imagine. This is the treatment period prior to the primary outcome period.|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed values.|||units on a scale||Standard Deviation|Mean
1390477|NCT01352741|Primary|Change in the Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|"The primary endpoint is defined as the comparison of tapentadol prolonged release (PR) 300 mg plus 200 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) from the randomization visit to the final evaluation visit.~Theoretically a maximum decrease of -10 and an increase of +4 in the pain intensity would have been possible. A negative sign indicates a decrease in pain intensity from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline visit)."|Randomization (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
1390478|NCT01352715|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline|Fasting was for 8 hours and the metabolic panel was drawn locally.|Study entry and week 48|Intention to treat: All 512 participants without a major eligibility violation with data available at entry and week 48 were included in their assigned randomized treatment arm. total cholesterol (Arm A N=216 B N=220) HDL (Arm A N=219 B N=223) LDL (Arm A N=202 B N=205) triglycerides (Arm A N=219 B N=222), glucose (Arm A N=213 B N=223)|||mg/dL||95% Confidence Interval|Mean
1390479|NCT01352715|Secondary|Percentage of Time Spent in Hospital|The percentage of total study time that participants were in hospital.|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without a major eligibility violation were in the analysis: participants were analyzed per original assigned randomized treatment.|||percentage of time spent in hospital|||Number
1390480|NCT01352715|Secondary|Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death|Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.|||participants|||Number
1390481|NCT01352715|Secondary|Number of Participants With a New AIDS-defining Events or Death|AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO)|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.|||participants|||Number
1390482|NCT01352715|Secondary|Number of Participants Discontinuing Randomized Treatment for Toxicity|Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations.|From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)|Competing risk approach: Time was measured from start of randomized treatment until the date of randomized treatment discontinuation for toxicity. Randomized treatment discontinuation for other reasons was considered as an independent competing risk, and participants discontinuing the study were censored on the date of last participant contact.|||participants|||Number
1390483|NCT01352715|Secondary|Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline|The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs.|From start of randomized treatment to off randomized treatment (up to 96 weeks)|As treated: Participants on randomized treatment are included in this analysis.|||participants|||Number
1390484|NCT01352715|Secondary|Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure|Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline.|From study entry through to week 96|Participants with virologic failure, and with a pair of baseline and virologic failure sequences available, were included in the analysis.|||participants|||Number
1390485|NCT01352715|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry.|Study entry and week 48|Intention to treat: All 488 participants without a major eligibility violation, and with baseline and week 48 data available were used in the analysis: participants were analyzed per original assigned randomized treatment.|||cells/mm^3||95% Confidence Interval|Mean
1390486|NCT01352715|Primary|Cumulative Probability of Virologic Failure by Week 48|The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used.|From study entry to week 48|Intention to treat: All 512 participants without a major eligibility violation were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
1390487|NCT01352585|Secondary|Hematocrit Level||1 year|Safety Set|||Hematocrit (fraction of 1)||Standard Deviation|Mean
1390488|NCT01352585|Secondary|Hemoglobin Concentration||1 year|Safety set|||g/L||Standard Deviation|Mean
1390489|NCT01352585|Secondary|Differential WBC Count||1 year|Safety Set|||percent||Standard Deviation|Mean
1390490|NCT01352585|Secondary|White Blood Cell (WBC) Count||1 year|Safety Set|||WBC Count (x10^9/L)||Standard Deviation|Mean
1390491|NCT01352585|Secondary|Red Blood Cell (RBC) Count||1 year|The Safety Set consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride.|||RBC Count (x10^12/L)||Standard Deviation|Mean
1390492|NCT01352585|Secondary|Platelet Count||1 year|FAS|||Platelets (x10^9/L)||Standard Deviation|Mean
1390494|NCT01352585|Primary|Number of Patients With Platelet Count ≤600x10^9/L After 12 Months|A platelet count of ≤600x10^9/L after 12 months is considered at least a partial response.|1 year|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who had at least 1 post-baseline platelet count and their JAK2 mutation status was assessed. 35 patients in the FAS had a viable platelet sample.|||participants|||Number
1390495|NCT01352546|Primary|Ability to Achieve Pain Free Intercourse.|Patients need to be able to transition from the use of vaginal dilators to pain free intercourse, or to be able to continue using the #5 or #6 of 6 dilators in the absence of a partner.|one year||||percentage of participants|||Number
1390496|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Erectile Function Domain|Self-reported erectile function over the past 4 weeks. IIEF erectile function was the sum of Q1 through Q5 and Q15 of the IIEF. Q1 through Q5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Q15 was scored 1 (no/low confidence) to 5 (high confidence). IIEF erectile function domain scores ranged from 1 to 30. Change was defined as endpoint minus baseline domain score. Change in IIEF erectile function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF EF domain score. Higher scores were indicative of better erectile function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390497|NCT01352507|Secondary|Change in PAIRS Time Concerns Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The time concerns domain score was the average score for Items 1, 2, 6, 7, 8, 20, 24, and 25. Time concern domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS time concerns at Week 8 and Week 18 were averaged to produce an overall change in PAIRS time concerns domain score. Higher scores were indicative of more time concerns.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390498|NCT01352507|Secondary|Change in PAIRS Spontaneity Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The spontaneity domain score was the average score for Items 3, 12, 13, 16, 17, 19, 21, 22, and 28. Spontaneity domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS spontaneity domain at Week 8 and Week 18 were averaged to produce an overall change in PAIRS spontaneity domain score. Higher scores were indicative of greater spontaneity.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390499|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 3|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score was determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Change in the percentage of yes responses to SEP Q3 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q3."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 SEP post-baseline measurement.|||"percentage of yes responses"||Standard Deviation|Mean
1390500|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function over the past 4 weeks. IIEF orgasmic function was the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF orgasmic function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF orgasmic function domain score. Higher scores were indicative of better orgasmic function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390501|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire over the past 4 weeks. IIEF sexual desire was the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF sexual desire domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF sexual desire domain score. Higher scores were indicative of increased sexual desire.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390502|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction over the past 4 weeks. IIEF intercourse satisfaction was the sum of Q6, Q7, and Q8 of the IIEF. Scores ranged from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15. Change was defined as endpoint minus baseline domain score. Change in IIEF intercourse satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF intercourse satisfaction domain score. Higher scores were indicative of an increase in intercourse satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390503|NCT01352507|Secondary|Drug Attributes Questionnaire (DRAQ) at Week 18|DRAQ was a questionnaire used to record explanations for why participants preferred a drug. Participants identified their first and second reasons for drug preference from a choice of 7 reasons. Each reason for drug preference includes participants who selected that reason as their first or second reason.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the DRAQ, and were analyzed according to their assigned treatment.|||percentage of participants|||Number
1390535|NCT01352221|Secondary|Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)|ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|Baseline to Week 8 - double-blind phase|FAS|||g/dL||Standard Deviation|Mean
1390504|NCT01352507|Secondary|Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The sexual self-confidence domain score was the average score for Items 5, 10, 15, 23, 27, and 29. Sexual self-confidence domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS sexual self-confidence domain scores at Week 8 and Week 18 were averaged to produce an overall change in PAIRS sexual self-confidence domain score. Higher scores were indicative of greater sexual self-confidence.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390505|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 2|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of “yes” responses at endpoint minus the percentage of “yes” responses at baseline. Change in percentage of “yes” responses to SEP Q2 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q2."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 post-baseline SEP measurement.|||"percentage of yes responses"||Standard Deviation|Mean
1390506|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction over the past 4 weeks. IIEF overall satisfaction was the sum of Q13 and Q14. Scores ranged from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF overall satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF overall satisfaction domain score. Higher IIEF overall satisfaction domain scores were indicative of greater overall satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1390507|NCT01352507|Secondary|Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ|PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, “For the treatment preference you selected in Q1, what is your degree of preference?”. Choices were moderate or strong.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.|||percentage of participants|||Number
1390508|NCT01352507|Primary|"Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the Phosphodiesterase 5 Inhibitor Treatment Preference Questionnaire (PITPQ)"|PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.|||percentage of participants||95% Confidence Interval|Number
1390509|NCT01352468|Secondary|Proportion of Words Read Accurately Using the AIMSWEB|Number of words read correctly divided by number of words read|8 weeks||||proportion of words read accurately||Standard Deviation|Mean
1390510|NCT01352468|Secondary|Reaction Time Variability on go/No-go Task|Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task|8 weeks|Go/No-Go task data was not available for one participant in the Sham Cognitive Training condition|||milliseconds||Standard Deviation|Mean
1390511|NCT01352468|Primary|Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale|"Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0=Never; 1=Occasionally; 2=Often; 3=Very often); higher scores indicate higher severity of ADHD symptoms."|8 weeks||||units on a scale||Standard Deviation|Mean
1390512|NCT01352442|Secondary|Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months||||Scores on a scale||95% Confidence Interval|Mean
1390513|NCT01352442|Primary|Uncorrected Near Visual Acuity 20/32 or Better||12 months||||percentage of subjects|||Number
1390514|NCT01352416|Primary|Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.|Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.|The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged|Study was prematurely terminated. Data for this Outcome Measure were not collected||||||
1390515|NCT01352221|Other Pre-specified|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 64 (Full Analysis Set, FAS)|"Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 64 (FAS), after 12-week double blind phase and 52 weeks open-label ST10 treatment (in participants with CD only).~The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150–220, moderate–severe Crohn's is typically a CDAI 220–450, and severe disease is defined as a CDAI >450."|Baseline to Week 64 - open-label phase|FAS|||score on a scale||Full Range|Median
1390516|NCT01352221|Other Pre-specified|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 12 (Full Analysis Set, FAS)|"Change from baseline (randomisation) in Crohn's Disease Activity Index (CDAI) score at Week 12 (FAS), end of double-blind phase (in subjects with CD).~The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150–220, moderate–severe Crohn's is typically a CDAI 220–450, and severe disease is defined as a CDAI >450."|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||score on a scale||Full Range|Median
1390517|NCT01352221|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.~The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 64 - open-label phase|FAS|||score on a scale||Standard Deviation|Mean
1390518|NCT01352221|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.~The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 12 - double-blind phase|Full Analysis Set (FAS)|||score on a scale||Standard Deviation|Mean
1390519|NCT01352221|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||percent||Standard Deviation|Mean
1390520|NCT01352221|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||μg/dL||Standard Deviation|Mean
1390521|NCT01352221|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||percent||Standard Deviation|Mean
1390522|NCT01352221|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||μg/dL||Standard Deviation|Mean
1390523|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
1390524|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
1390525|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||Participants|||Count of Participants
1390526|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 36 (Full Analysis Set), after 12-week double-blind phase and 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||Participants|||Count of Participants
1390527|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 16 (Full Analysis Set), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment|Baseline to Week 16 - open-label phase|FAS|||Participants|||Count of Participants
1390528|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the ‘Week 64’ visit was outside the visit window of 64 weeks ± 2 days|Baseline to Week 64 EOS - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1390529|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1390530|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment|Baseline to Week 48 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1390531|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1390532|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment|Baseline to Week 24 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1390533|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment|Baseline to Week 20 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1390534|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment.|Baseline to Week 16 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1390537|NCT01352221|Secondary|Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 end of double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
1390538|NCT01352221|Secondary|Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥2 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
1390539|NCT01352221|Secondary|Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
1390540|NCT01352221|Primary|Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate.|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
1390541|NCT01352117|Secondary|Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A|KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)|All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.|||cumulative events per 100 participants||95% Confidence Interval|Number
1390542|NCT01352117|Secondary|Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A|KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)|All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.|||cumulative events per 100 participants||95% Confidence Interval|Number
1390543|NCT01352117|Secondary|Change in Peripheral Blood CD4+ Lymphocyte Cell Count|Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET.|Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|All eligible participants who initiated study treatment and had CD4 cell count results available at screening and the respective Step 1 visit or at Step 2 entry and the respective Step 2 visit.|||cells/mm^3||Inter-Quartile Range|Median
1390544|NCT01352117|Secondary|Change in log10 HIV-1 Plasma Viral Load From Entry|Absolute change in log10 HIV-1 RNA from entry at study visits calculated as value at a given time point minus value at entry. This outcome was initially specified in the study protocol. However, at the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. It would be misleading to calculate change from entry to HIV RNA-1 levels that could not be quantified. Therefore, the data collected did not support the outcome and the analytic method initially proposed in the study protocol, and this outcome measure could not be analyzed. The SAP updated the HIV-1 RNA outcome measure to HIV-1 RNA suppression at study visits (please refer to the secondary outcome measure #20).|Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|At the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. Therefore, this outcome measure could not be analyzed.||||||
1390545|NCT01352117|Secondary|Percentage of Participants With ARV Dose Modification|ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.|From treatment dispensation to Week 96|All eligible participants who initiated study treatment.|||percentage of participants|||Number
1390546|NCT01352117|Secondary|Percentage of Participants With HIV-1 RNA Suppression|HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET.|Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|All eligible participants who initiated study treatment and had HIV-1 RNA results available at the specific visit. HIV-1 RNA testing was done locally using Abbott RealTime HIV-1 Test or Roche AmpliPrep/Taqman HIV-1 Test. Only Arm A participants could enter Step 2 to initiate delayed ET.|||percentage of participants|||Number
1390693|NCT01350245|Primary|Probability of Overall Survival at 15 Months Post-treatment|Probability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant.|15 months||||percentage of probability|||Number
1390547|NCT01352117|Secondary|Percentage of Participants With Etoposide Dose Modification|Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.|From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)|All eligible participants who initiated study treatment. Arm A participants are limited to those who entered Step 2 to initiate delayed ET.|||percentage of participants|||Number
1390548|NCT01352117|Secondary|Cumulative Incidence of KS-IRIS|KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease.|From study entry to Week 12|All eligible participants who initiated study treatment.|||cumulative events per 100 participants||95% Confidence Interval|Number
1390549|NCT01352117|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.|All eligible participants who initiated study treatment.|||Participants|||Count of Participants
1390550|NCT01352117|Secondary|Cumulative Incidence of Initial KS Complete Response by Week 96|KS complete response (CR) compared to study entry based on clinical evaluation of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as “PR and CR combined and separately” to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS CR, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on CR separately was withdrawn.|From study treatment initiation to 96 weeks|Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.||||||
1390551|NCT01352117|Secondary|Cumulative Incidence of Initial KS Partial Response by Week 96|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as “PR and CR combined and separately” to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS complete response, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on PR separately was withdrawn.|From study treatment initiation to 96 weeks|Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.||||||
1390552|NCT01352117|Secondary|Cumulative Incidence of Initial KS Partial or Complete Response by Week 96|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From entry through 96 weeks|All eligible participants who initiated study treatment.|||cumulative events per 100 participants||95% Confidence Interval|Number
1390553|NCT01352117|Secondary|Cumulative Incidence of Initial KS Progressive Disease by Week 96|KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From entry through 96 weeks|All eligible participants who initiated study treatment.|||cumulative events per 100 participants||95% Confidence Interval|Number
1390554|NCT01352117|Secondary|Premature Study Discontinuation by Week 96|Premature study discontinuation by Week 96 due to any reason, including death.|Entry through Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).|||Participants|||Count of Participants
1390555|NCT01352117|Secondary|KS Partial or Complete Response at Week 96 Compared to Study Entry|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
1390556|NCT01352117|Secondary|KS Complete Response at Week 96 Compared to Study Entry|KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
1390557|NCT01352117|Secondary|KS Partial Response at Week 96 Compared to Study Entry|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
1390558|NCT01352117|Secondary|KS Progressive Disease at Week 96 Compared to Study Entry|KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
1390559|NCT01352117|Secondary|Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry|KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS PD, initiation of an alternate KS treatment, or no follow-up at Week 96 including death and missed visit), E2 (Stable: in follow-up at Week 96 with no KS progression nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 96, with KS PR or CR and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PD, stable, PR or CR) compared to study entry was evaluated at Week 96 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and deaths are from entry through Week 96.|Entry through Week 96.|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).|||Participants|||Count of Participants
1390560|NCT01352117|Secondary|Premature Study Discontinuation by Week 48|Premature study discontinuation by Week 48 due to any reason, including death.|Entry through Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public).|||Participants|||Count of Participants
1390561|NCT01352117|Secondary|KS Partial or Complete Response at Week 48 Compared to Study Entry|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
1390562|NCT01352117|Secondary|KS Complete Response at Week 48 Compared to Study Entry|KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
1390563|NCT01352117|Secondary|KS Partial Response at Week 48 Compared to Study Entry|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
1390564|NCT01352117|Secondary|KS Progressive Disease at Week 48 Compared to Study Entry|KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
1390583|NCT01351480|Secondary|Patients With an Improvement in DAS Score Were Considered Responders at Week 48|Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score|The DAS 28 score will be performed at baseline and 48|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients|||participants|||Number
1390565|NCT01352117|Primary|Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry|KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS progression (PD), initiation of an alternate KS treatment, or no follow-up at Week 48 including death and missed visit), E2 (Stable: in follow-up at Week 48 with no KS PD nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 48, with KS partial or complete response (PR or CR) and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PR, stable, PR, CR) compared to study entry was evaluated at Week 48 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and dea|Entry through Week 48.|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the Data and Safety Monitoring Board's [DSMB] recommendation to close the study became public).|||Participants|||Count of Participants
1390566|NCT01351740|Secondary|Quality of Life as Assessed by MOS-HIV|Changes in MOS-HIV scores from baseline will be compared between randomized treatment arms.|24 and 48 weeks|||||||
1390567|NCT01351740|Secondary|Metabolic Parameters|Comparison will be made between randomized treatment arms with respect to changes in fasting lipids and glucose, highly sensitive C-reactive protein [hsCRP], and apolipoprotein [apo]B, and proportions of subjects developing abnormalities or crossing predefined limits (e.g. NCEP thresholds for lipids)|24 and 48 weeks|||||||
1390568|NCT01351740|Secondary|Total Serum Bilirubin Levels|Comparison will be made between randomized treatment arms.|24 and 48 weeks|||||||
1390569|NCT01351740|Secondary|Safety (Clinical and Laboratory Adverse Events)|Serious adverse events and discontinuations will be compared between randomized treatment arms|24 and 48 weeks|||||||
1390570|NCT01351740|Secondary|CD4 Cell Count Changes (Absolute and Fraction)|Comparison will be made between randomized treatment arms.|24 and 48 weeks|||||||
1390571|NCT01351740|Secondary|Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.|at or before 24 weeks|||||||
1390572|NCT01351740|Secondary|Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.|at or before 24 weeks.|||||||
1390573|NCT01351740|Secondary|Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.|at or before 48 weeks|||||||
1390574|NCT01351740|Secondary|Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL|Therapeutic drug monitoring (TDM) to determine atazanavir trough plasma level will be performed once on all subjects at 4-8 weeks|1 month (4-8 weeks)||||Participants|||Count of Participants
1390575|NCT01351740|Primary|Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.|at or before 48 weeks.||||Participants|||Count of Participants
1390576|NCT01351623|Primary|To Evaluate the Best Overall Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|2 years|Participants who completed 4 cycles of treatment or whose disease progressed prior to completion of 4 cycles.|||Participants|||Count of Participants
1390577|NCT01351506|Secondary|Acute Kidney Injury|New acute kidney injury in ICU|Acute kidney injury||||participants|||Number
1390578|NCT01351506|Secondary|Re Intubation Within 72 Hours|Patient who need re-intubation within 72 hours|ICU complications up to 28 days after ICU admission|All|||participants|||Number
1390579|NCT01351506|Primary|In Hospital Mortality|28 days mortality if patient still have be admitted in hospital.|within 28 days after ICU admission to dead|Total 465 patients|||participants|||Number
1390580|NCT01351480|Secondary|Number of Patients With Adverse Events|site will report the number of patients with adverse envents from Day 1 up to 52 weeks|all adverse events will be captured from Day 1 up to 52 weeks|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients|||participants|||Number
1390581|NCT01351480|Secondary|the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48|Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score (1-10 cm). Total maximum score was at high disease activity at baseline.|week 24 and Week 48|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients|||participants|||Number
1390582|NCT01351480|Secondary|To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24|DAS 28> 5.1=high disease activity DAS28 <3.2=low disease activity DAS28 <2.6=remission Criteria used in formula are number of tender joints based upon 28 joints, number of swollen joints based on 28 joints, ESR in mm/hr and patient global health core based on 0-10 mm|Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48|the number of participants who reached remission, low disease activity, moderate disease activity and high disease activity will be determined as based upon the DAS scale|||participants|||Number
1390584|NCT01351480|Primary|Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.|bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.|MRIs at Baseline and Week 48|osteitis on the MRIs from 27 patients at baseline and week 48|||participants|||Number
1390585|NCT01351415|Secondary|Percentage of Participants Who Are Alive at Month 6, 12, and 18|Percentage of participants who were alive at Month 6, 12 and 18 were reported.|Month 6, 12, 18|Intent to treat population included all randomized participants.|||Percentage of Participants||90% Confidence Interval|Number
1390586|NCT01351415|Secondary|Time to Progression (TTP) According to RECIST v1.1|The time to progression was defined as the time from baseline until disease progression as determined by the RECIST v1.1. TTP2 is defined as the interval between the day of randomization at PD1 and PD2. TTP3 is defined as the interval between the day of PD2 and PD3. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
1390587|NCT01351415|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to data cut-off date 24 June 2016 (approximately 5 years)|The safety population included all participants who had received at least one dose of any study drug.|||Percentage of Participants|||Number
1390588|NCT01351415|Secondary|Duration of Response (DoR) According to RECIST v1.1|Duration of response is defined as the time that measurement criteria are met for objective response (CR/PR) (whichever status is recorded first) until the first date of progression or death is documented. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than < 10 mm. PR was defined as greater than or equal to ≥30 % decrease in sum of longest diameter of target lesions in reference to baseline sum longest diameter.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
1390589|NCT01351415|Secondary|Percentage of Participants With Disease Control According to RECIST v1.1|The disease control rate is defined as CR or PR or stable disease (SD) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started for target lesions and the persistence of 1 or more non-target lesions.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Percentage of Participants||90% Confidence Interval|Number
1390590|NCT01351415|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1|The objective response is defined as complete response (CR) or partial response (PR) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Percentage of Participants||90% Confidence Interval|Number
1390591|NCT01351415|Secondary|Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS2 is defined as the time between randomization at PD1 and the date of PD2 or death, whichever occurs first. PFS3 is defined as the time between PD2 and the date of PD3 or death, whichever occurs first.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
1390592|NCT01351415|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
1390593|NCT01351337|Other Pre-specified|The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results|The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative). The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive). The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.|During the operation||||percentage of stimulation sites|||Number
1390694|NCT01350245|Primary|Disease-Free Survival (DFS)|1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.|1 year post-transplant||||percentage of patients|||Number
1390594|NCT01351337|Secondary|Postoperative Motor Function and Long-time Functional Status|Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge. The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale. Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed. Grade 2: Muscle can onlly move if resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.|3 days to 6 months after surgery||||participants|||Number
1390595|NCT01351337|Primary|Extent of Tumor Resection|Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas. The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume. Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.|within 3 days||||participants|||Number
1390596|NCT01351090|Secondary|Pain Intensity Difference (PID) Scores|Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.|6 hours after study drug administration||||units on a scale||Standard Deviation|Mean
1390597|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours||8-hour intervals from 24 hours after the start of dosing through 48 hours||||mg||Standard Deviation|Mean
1390598|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours||8-hour intervals from the start of dosing through 48 hours||||mg||Standard Deviation|Mean
1390599|NCT01351090|Primary|Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours||8-hour intervals from the start of dosing through 24 hours||||mg||Standard Deviation|Mean
1390600|NCT01351077|Other Pre-specified|Number of Patients Whose Referred Evaluations and Services Were Completed||one year||||Participants|||Count of Participants
1390601|NCT01351077|Other Pre-specified|Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result||one year|The denominator was the number of children with a positive screen|||Participants|||Count of Participants
1390602|NCT01351077|Other Pre-specified|Number of Children With a Positive Screen||one year|The denominator was number of children for whom a standard developmental screening tool was administered|||Participants|||Count of Participants
1390603|NCT01351077|Secondary|Age of Children Diagnosed With Developmental Delay||one year|The denominator was only children diagnosed with developmental delay|||months||Standard Deviation|Mean
1390604|NCT01351077|Primary|Number of Children Screened for Developmental Delay||one year||||Participants|||Count of Participants
1390605|NCT01351064|Secondary|Percent of Patients Receiving ADHD Care Component||one year||||percentage of participants|||Number
1390606|NCT01351064|Primary|Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment||one year||||number of kids|||Number
1390607|NCT01351025|Secondary|Number of Participants With Safety Endpoints After Study Treatment Cross-over (Week 24 to Week 48)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events after study treatment cross-over (week 24 to week 48).~The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 24 to week 48|participants who crossed over study treatment at week 24|||participants|||Number
1390608|NCT01351025|Secondary|Number of Participants With Safety Endpoints Before Study Treatment Cross-over (Baseline to Week 24)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events prior to study treatment cross-over (baseline to week 24).~The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 0 to week 24|participants who started study treatment|||participants|||Number
1390609|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD163 (log10 Transformed)|"CD163 (Cluster of Differentiation 163) is a protein that in humans encoded by the CD163 gene; and sCD163 is soluble CD163.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/ml||Inter-Quartile Range|Median
1390610|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in P-selectin (log10 Transformed)|"P-selectin is a protein that in humans encoded by the SELP gene. P-selectin functions as a cell adhesion molecule (CAM) on the surfaces of activated endothelial cells, which line the inner surface of blood vessels, and activated platelets.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/ml||Inter-Quartile Range|Median
1390611|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD14 (log10 Transformed)|Soluble cluster of differentiation 14 (sCD14) is a human gene. Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline].|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/ml||Inter-Quartile Range|Median
1390612|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in CD40L (log10 Transformed)|"Cluster of differentiation 40 (CD40L) is a costimulatory protein found on antigen presenting cells and is required for their activation.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/ml||Inter-Quartile Range|Median
1390613|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in IP-10 (log10 Transformed)|"IFN-gamma-inducible protein 10 (IP-10 or CXCL10) is a chemokine secreted from cells stimulated with type I and II IFNs and LPS, is also a chemoattractant for activated T cells.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/ml||Inter-Quartile Range|Median
1390614|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in MCP-1 (log10 Transformed)|"Monocyte chemoattractant protein-1 (MCP-1/CCL2) is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/ml||Inter-Quartile Range|Median
1390615|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD8+ T-cell Activation Percent|CD8+ T-cell activation percent (% CD38+/DR+ of CD8+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||percent||Inter-Quartile Range|Median
1390616|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 D-dimer|D-dimer in log10 ng/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/mL||Inter-Quartile Range|Median
1390617|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD4+ T-cell Activation Percent|CD4+ T-cell activation percent (% CD38+/DR+ of CD4+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||percent||Inter-Quartile Range|Median
1390618|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 IL-6|IL-6 (Interleukin 6) in log10 pg/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/mL||Inter-Quartile Range|Median
1390619|NCT01350999|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol|Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390620|NCT01350999|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390621|NCT01350999|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390622|NCT01350999|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390623|NCT01350999|Secondary|Percent Change From Baseline in Triglyceride Level||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set (all participants who were randomized and received at least one dose of the investigational product) with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390624|NCT01350999|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390695|NCT01350232|Secondary|Cytokine Profile|To characterize the profiles of cytokines released following administration of the lymphoid portion of the transplant (donor lymphocyte infusion [DLI]).|Through 5 years after infusion|||||||
1390625|NCT01350999|Primary|Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390626|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390627|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390628|NCT01350999|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390629|NCT01350973|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390630|NCT01350973|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390631|NCT01350973|Secondary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390632|NCT01350973|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
1390633|NCT01350973|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time|The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390634|NCT01350973|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time|The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390635|NCT01350973|Secondary|Percent Change From Baseline in Total Cholesterol Over Time|The percentage change between total cholesterol measured at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390636|NCT01350973|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time|The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390637|NCT01350973|Secondary|Percent Change From Baseline in Triglyceride Level Over Time|The percentage change between triglycerides collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
1390638|NCT01350973|Primary|Percent Change From Baseline in Triglyceride Level at the Final Visit|The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.|Baseline and 12 weeks|Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data.|||percent change||Standard Error|Least Squares Mean
1390639|NCT01350947|Primary|Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.|Complete Hematologic Response is defined as: bone marrow evaluation shows <= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts|24 months||||percentage of patients|||Number
1390640|NCT01350934|Other Pre-specified|Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12|"The term vitamin D insufficiency is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D <20 ng/mL."|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.|||Percentage of Participants|||Number
1390641|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-CTx at Month 12|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
1390696|NCT01350232|Secondary|Quality of Life|To describe the quality of life and functional status following transplantation.|Through 5 years post infusion|||||||
1390697|NCT01350232|Secondary|Immune Recovery|To assess the pace of lymphoid recovery and associated risk for opportunistic infections and relapse (return to recipient erythropoiesis) in this patient population.|100 days post infusion through 5 years post infusion|||||||
1390642|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-P1NP at Month 12|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
1390643|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
1390644|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
1390645|NCT01350934|Primary|Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12|BMD at the lumbar spine was assessed by DXA at baseline and Month 12.|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1390646|NCT01350934|Primary|Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6|BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.|Baseline and Month 6|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1390647|NCT01350804|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data|Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||mm/hr||Standard Deviation|Mean
1390648|NCT01350804|Secondary|Change From Baseline in hsCRP - Observed Data|Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||mg/L||Standard Deviation|Mean
1390649|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Deviation|Mean
1390650|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups|||score on a scale||Standard Error|Least Squares Mean
1390657|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient’s Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1390651|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Observed Data|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation."|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Deviation|Mean
1390652|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)|"The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for this analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups.|||score on a scale||Standard Error|Least Squares Mean
1390653|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Percentage of participants|||Number
1390654|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. Participants with missing data were considered non-responders at the respective time point. Placebo and Abatacept participants were considered non-responders from the time of treatment switch.|||Percentage of participants|||Number
1390655|NCT01350804|Secondary|Percentage of Participants Achieving ACR50|ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Percentage of participants|||Number
1390656|NCT01350804|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Error|Least Squares Mean
1390686|NCT01350271|Primary|Cure Rate|Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up.|||percentage of participants|||Number
1390687|NCT01350258|Secondary|Overall Survival|To assess overall survival in patients undergoing HSCT treated on this trial.|At 1 and 3 years|||||||
1390658|NCT01350804|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient’s assessment of RA pain, patient’s global assessment of disease activity, physician’s global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Percentage of participants|||Number
1390659|NCT01350583|Secondary|Number of Participants With Improvement in Pain Indices|Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.||||||
1390660|NCT01350583|Secondary|Percent of Patients Where Treatment Was Well Tolerated|Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.||||||
1390661|NCT01350583|Primary|Percent of Patients With Improvement|Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.|4 weeks per participant|Results data was not calculated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.||||||
1390662|NCT01350544|Primary|Medication Adherence|We used a repeated measures linear regression modeling continuous adherence with intervention, linear time, and their interaction, and demographic covariates. Continuous adherence is measured as average percentages of doses taken.|Baseline, 1.5 months, 3 months, 4.5 months, and 6 months||||Percentage of doses taken||Standard Deviation|Mean
1390663|NCT01350479|Primary|MRSA Transmission|Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident|Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment|We analyzed the number of gown and glove swabs from HCW interacting with MRSA and non-MRSA colonized residents.|||Proportion of swabs positive for MRSA|swabs||Number
1390664|NCT01350414|Secondary|Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage of change from Baseline||Standard Deviation|Mean
1390665|NCT01350414|Secondary|Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage of change from Baseline||Standard Deviation|Mean
1390666|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Number of Hospitalizations for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/subjects/year||95% Confidence Interval|Number
1390667|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Proportion of subjects with hospitalizations for respiratory symptoms.|12 Month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage of subjects hospitalized||95% Confidence Interval|Number
1390668|NCT01350414|Secondary|Emergency Room (ER) Visits for Respiratory Symptoms|Number of Emergency Room Visits for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/subject/year||95% Confidence Interval|Number
1390669|NCT01350414|Secondary|Emergency Room Visits for Respiratory Symptoms|Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage subjects ER respir. symptoms||95% Confidence Interval|Number
1390670|NCT01350414|Secondary|Respiratory Adverse Events|Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the “Respiratory System” that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage subjects with respiratory AE||95% Confidence Interval|Number
1390688|NCT01350258|Secondary|Engraftment Rate and Lymphoid Reconstitution|To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial.|100 days post-transplant|||||||
1390689|NCT01350258|Secondary|GVHD Incidence and Severity|To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen using MEL for T cell tolerization as well as tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|At 1 and 3 years|||||||
1390671|NCT01350414|Secondary|Respiratory Adverse Events|Number of respiratory adverse events per subject per year. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the “Respiratory System” that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/number of subject/Year||95% Confidence Interval|Number
1390672|NCT01350414|Secondary|Severe Exacerbations|Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/Number of subjects/Year||95% Confidence Interval|Number
1390673|NCT01350414|Primary|Severe Exacerbations|"The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%.~Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02)."|12 month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage subjects severe exacerbations||95% Confidence Interval|Number
1390674|NCT01350401|Secondary|Peak Persistence of Modified T-cells in the Peripheral Blood|Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)|Days 1, 5-9, 12-16, weekly thereafter through Week 12, monthly thereafter through Month 12, and during LTFU|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with persistence data|||copies per μg of DNA||Full Range|Mean
1390675|NCT01350401|Secondary|Determine the Functional Properties and Phenotype of Modified T-cells From Peripheral Blood and Tumor Sites.|Measurement of functionality of NY-ESO-1ᶜ²⁵⁹T cells in the blood and tumor sites.|8 Weeks post T-cell infusion|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with functionality data|||percentage of T cell sub population|T-cell sub population||Number
1390676|NCT01350401|Secondary|Tumor Response|Number of participants with response as assessed by RECIST (version 1.1) criteria.|Change from Baseline, every 4 weeks until Month 5 and then every other month through Month 11||||Participants|||Count of Participants
1390677|NCT01350401|Primary|Adverse Events Related to Study Treatment|Number of Participants with NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3|Up to 12 months|Participants who received cytoreductive chemotherapy followed by IV infusion of NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
1390678|NCT01350388|Secondary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma hsCRP concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1390679|NCT01350388|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma IL-6 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1390680|NCT01350388|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma TNF-α concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1390681|NCT01350388|Primary|Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks|The percent difference in TGF-beta1 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1390682|NCT01350388|Primary|Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in adiponectin concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1390683|NCT01350388|Primary|Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in thiobarbituric acid reactive substance (TBARS) concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1390684|NCT01350271|Secondary|Faecal Egg Count Reduction 2 (FECR2)|FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up were included in the analysis|||percentage of eggs excreted||Standard Deviation|Mean
1390685|NCT01350271|Secondary|Faecal Egg Count Reduction 1 (FECR1)|FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow-up, were included in the analysis|||percentage of eggs excreted|||Number
1390690|NCT01350258|Secondary|Relapse Rate|To compare relapse rates in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|At 1 and 3 years|||||||
1390699|NCT01350232|Secondary|Acute Graft Versus Host Disease|To describe the incidence and severity of acute and chronic GVHD following this reduced intensity transplant from partially matched related donors using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|100 days post infusion|||||||
1390700|NCT01350232|Secondary|Overall Survival|To determine the overall survival at 6 months post-transplant in patients receiving a matched or partially-matched related donor transplant after reduced-intensity conditioning.|6 months post infusion|||||||
1390701|NCT01350232|Secondary|Organ Toxicity|To assess organ toxicity related to fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation in a population with severe sickle cell anemia.|30 days post infusion|||||||
1390702|NCT01350232|Primary|Stable Engraftment|To determine if the reduced intensity preparative regimen of fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation will generate stable engraftment with donor hematopoietic stem cells in at least 80% of patients with severe sickle cell anemia.|180 days post-infusion|||||||
1390703|NCT01350141|Secondary|Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)|Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.|Day 1 up to Day 141|Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).|||participants|||Number
1390704|NCT01350141|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters|Number of participants with clinically significant changes in vital signs and ECG findings were reported. Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of greater than 200 millisecond (msec) or maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval, maximum increase from baseline of greater than (>) 30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment.|Screening up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1390705|NCT01350141|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment.|Screening up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1390706|NCT01350141|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant’s usual function), moderate (interferes to some extent with participant’s usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Treatment-emergent AEs|||Number
1390707|NCT01350141|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, TESAEs and treatment-related TEAEs were reported.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1390708|NCT01350141|Secondary|Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|"Efficacy analysis set. Number of participants analyzed = participants who were evaluable for this measure at given time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol."|||percent change||Standard Deviation|Mean
1390709|NCT01350141|Secondary|Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'Number of participants analyzed' = participants who were evaluable for this measure at given time points for each arm. Results for change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.|||mg/dL||Standard Deviation|Mean
1390939|NCT01347840|Secondary|Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)|These variables will measure the combined effects of hormone concentration and duration.|16 months||||units on a scale|||Number
1390710|NCT01350141|Secondary|Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)||Day 29, 57, 85|"Efficacy analysis set. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number of Participants Analyzed signifies those participants who were evaluable for this measure at given time points, for each group respectively."|||percentage of participants|||Number
1390711|NCT01350141|Secondary|Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)||Day 29, 57, 85|"Efficacy analysis set. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number of participants analyzed signifies those participants who were evaluable for this measure at given time points, for each group respectively."|||Percentage of participants|||Number
1390712|NCT01350141|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 85|"Efficacy analysis set included all participants who received at least 1 dose of study medication and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
1390713|NCT01350128|Secondary|Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7|Change from baseline in 12-hour post-dose trough FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liters||95% Confidence Interval|Least Squares Mean
1390714|NCT01350128|Secondary|Peak Change From Baseline in IC on Day 7|Peak change from baseline in IC|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liters||95% Confidence Interval|Least Squares Mean
1390715|NCT01350128|Secondary|Peak Change From Baseline in FEV1 on Day 7|Peak change from baseline in FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
1390716|NCT01350128|Secondary|Change From Baseline in Morning Pre-dose FEV1 on Day 7|Change from baseline in morning pre-dose FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
1390717|NCT01350128|Secondary|Peak Change From Baseline in IC on Day 1|Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)|Day 1|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
1390718|NCT01350128|Secondary|Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1|Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)|Day 1|MITT Population: This includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Percent|||Number
1390719|NCT01350128|Secondary|Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1|Time to onset of action ( ≥10% improvement in FEV1)|Day 1 (15 min, 30 min, 1 hour, 2 hours)|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||% of subjects|||Number
1390720|NCT01350128|Secondary|Peak Change From Baseline in FEV1 on Day 1|Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)|Day 1|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
1390721|NCT01350128|Primary|FEV1 AUC0-12|FEV1 AUC0-12 following chronic dosing (1 week), normalized.|Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)|Modified Intent to Treat (MITT) Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
1390722|NCT01350115|Secondary|Measure: Disease Burden by BCC Tumor Counts|BCC tumor counts were performed separately for five body regions: head and neck, trunk back, trunk front (including axillae and groin), upper extremities and lower extremities (including buttocks). During the counting, the BCC tumors, were categorized upon inspection by their longest diameter measurement (<10 mm, 10-19 mm, 20-29 mm, and >+30mm), and also by the type of BCC (superficial, nodular, other). The counts for all of the BCC type and size categories were determined (or estimated if many small lesions) for each body region. The body region counts were summated to provide the overall BCC tumor count.|Baseline, day 85, and day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.|||Number of BCC tumors|||Number
1390723|NCT01350115|Secondary|Histological Clearance Assessment of Main Target BCCs|The main (and secondary, if appropriate) target BCC tumor area(s) was/were excised surgically and sent to a central laboratory for histological examination.|day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.|||Percentage of participants|||Number
1390940|NCT01347840|Primary|Area Under the Curve of Ghrelin and GLP-1|These variables will measure the combined effects of hormone concentration and duration.|16 months||||units on a scale|||Number
1390724|NCT01350115|Primary|Clinical Clearance Assessment of Main Target Basal Cell Carcinomas (BCCs)|The clinical response of the main target (and secondary target, as appropriate) BCC(s) to treatment was evaluated using the following 6-point scale comparing the assessment at the visit to the clinical presentation at Baseline: 0 = Worsening, 1 = No change, 2 = Slight clearance (1-25% improvement), 3 = Moderate clearance (26-75% improvement), 4 = Marked clearance (76-99% improvement),5 = Complete clearance (100% improvement) Complete clearance was defined as no clinical residual signs of carcinoma, as evaluated by the Investigator at a post-Baseline visit, with the exception of post-inflammatory changes such as minimal residual erythema or residual hyper-pigmentation or hypo-pigmentation or residual scarring.|Day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.|||Participants|||Number
1390725|NCT01350102|Secondary|Wound Area Measurements|Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).|Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months|The subject enrolled in Bacitracin with Vit C arm had measurements of the wound (width, depth, length) recorded beginning at week 0 through week 20. The subject enrolled in the AmeriGel wound care dressing alone had measurements recorded of the wound (width, depth, length) beginning at week 0 through week 2 before withdrawing from the study.|||cm|||Number
1390726|NCT01350102|Secondary|Length of Time for Wound Closure|Length of time for wound closure will be measured in days|Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months|Only the subject in the Bacitracin with Vit C arm achieved would healing. The subject in the AmeriGel would care dressing alone arm was withdrawn due to lack of healing and infection.|||Days|||Number
1390727|NCT01350102|Primary|Hgb A1c Level|Hgb A1c measures the average blood glucose over three months (% of hemoglobin). All subjects will be asked to get their hemoglobin A1c level at the beginning of the study and every three months for as long as they participate in the study.|Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months|"Enrollment and 3-month visit A1c levels were obtained for the subject in the Bacitracin with Vit C arm. Enrollment A1c level was obtained for the AmeriGel would care dressing alone.~However, this subject withdrew from the study before 3-month A1c level was obtained."|||percentage of hemoglobin|||Number
1390728|NCT01349972|Secondary|Progression-free Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.|4 years||||years||95% Confidence Interval|Median
1390729|NCT01349972|Secondary|Number of Patients With Minimal Residual Disease|Comparisons of the treatments with respect to MRD will be based on the number of patients with MRD at day 14 after the start of treatment.|From study start to 14 days after the start of treatment||||Participants|||Count of Participants
1390730|NCT01349972|Secondary|Overall Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.|4 years||||years||95% Confidence Interval|Median
1390731|NCT01349972|Secondary|Disease-free Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated. Disease-free survival Overall survival was defined from date of randomization to death or last known follow-up. Event free survival was defined as date of randomization to the first occurrence of persistent AML after 1 cycle of induction, relapse or death. Patients were censored for event free survival if they had received non-protocol therapy or a stem cell transplant.|Time from randomization until death from any cause or relapse or recurrence, assessed up to 2 years||||years||Full Range|Median
1390732|NCT01349972|Secondary|Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.|Up to 14 days after completion of study treatment|Number of evaluable subjects|||Number of events|||Number
1390733|NCT01349972|Primary|Complete Response Rate|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/cu mm and a platelet count of 100,000/cu mm, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. These criteria are taken from Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010;115:453-474|3 years||||participants|||Number
1390734|NCT01349959|Other Pre-specified|Gene Methylation Evaluated Using Quantitative Multiple Methylation-specific Polymerase Chain Reaction (QM-MSP)|Wilcoxon rank sum tests will be used to determine the association between azacitidine or entinostat exposure and methylation changes expressed as a categorical variable (i.e.: response or no response). Data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Up to 8 weeks|||||||
1390735|NCT01349959|Other Pre-specified|Feasibility of the Addition of Hormone Therapy, Evaluated by Calculating the Percentage of Patients With Disease Progression That go on to Receive Hormonal Therapy||Up to 3 years|||||||
1390736|NCT01349959|Other Pre-specified|Confirmed Response Rate to Azacitidine and Entinostat Plus the Addition of Hormone Therapy|Will be estimated in each cohort. All evaluable patients who receive hormonal therapy will be used for this analysis.|Up to 3 years|||||||
1390737|NCT01349959|Other Pre-specified|Circulating DNA Evaluated Using QM-MSP|Data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Up to 8 weeks|||||||
1390738|NCT01349959|Other Pre-specified|Change in Expression of Relevant Genes (e.g., ER Alpha and RAR Beta) Evaluated by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|To evaluate baseline and change in candidate gene re-expression such as ER re-expression in malignant tissue, the absolute difference between prior to and following combination therapy (i.e., at 8 weeks) will be estimated and the median difference will be reported. These data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Baseline to up to 8 weeks|||||||
1390741|NCT01349959|Secondary|Clinical Benefit Rate Estimated by the Number of Patients Who Achieve a Confirmed Response Plus the Number of Patients Who Have Stable Disease for a Duration of at Least 6 Months Divided by the Total Number of Evaluable Patients|All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.|Up to 3 years|||||||
1390742|NCT01349959|Primary|Confirmed Response Rate (Complete or Partial Response Noted as the Objective Status on Two Consecutive Evaluations at Least 4 Weeks Apart) Assessed by RECIST|The proportion of successes will be estimated independently for each cohort by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 3 years||||Percentage of participants||95% Confidence Interval|Number
1390743|NCT01349933|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented.|The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years|Analysis not conducted due to having too few patients with evaluable for this endpoint.||||||
1390744|NCT01349933|Secondary|Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)|Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. Progressive Disease (PD) is defined as either a new lesion of a 20% increase in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes. Stable Disease (SD) is defined as not having a PD, CR, or PR.|Up to 3 years|All patients who began protocol treatment were included in this analysis.|||Participants|||Count of Participants
1390745|NCT01349933|Secondary|Progression-free Survival|Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.|From registration to the first of either death due to any cause or progression, assessed up to 3 years|All patients who began protocol treatment were included in this analysis.|||months||95% Confidence Interval|Median
1390746|NCT01349933|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All patients that started protocol therapy were included in this analysis.|||months||95% Confidence Interval|Median
1390747|NCT01349933|Secondary|Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the severe or worse adverse events will be assessed, regardless of relationship to the study treatment. The number of patients reporting a grade 3 or higher event were counted.|Up to 30 days after completion of study treatment|All patients that began protocol treatment were included in this analysis.|||Participants|||Count of Participants
1390748|NCT01349933|Primary|Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart|Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|6 months||||percentage of participants|||Number
1390749|NCT01349933|Primary|Proportion of Patients Alive and Progression-free|The primary endpoint of this trial is the proportion of patients alive and progression-free at 6 months. Progression status is evaluated using RECIST version 1.1. A Progression is defined as either: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (less than 1.0 cm short axis) and increased to greater than or equal to 1 cm short axis during follow up. Or, at least a 20% increase in sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes.|6 months||||participants|||Number
1390750|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation|The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline, Week 6, Week 22|Participants who had both blinded and unblinded scores available for analysis.|||Correlation coefficient||90% Confidence Interval|Number
1390751|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers|Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)|Participants who had both baseline serum or stool measurements available for analysis.|||Correlation coefficient||90% Confidence Interval|Number
1390774|NCT01349907|Secondary|Time to First Total Y-MRS 50% Response|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to 50% response is the number of days on treatment to achieve a 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Days||95% Confidence Interval|Median
1390752|NCT01349920|Primary|Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22|To determine R^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R^2 at weeks 6 and 22 is approximately 0.7.|Baseline and Week 6 or 22|Participants who had a blinded CDEIS score and measurements for each of the biomarkers included in the models at both baseline and at Week 6 or 22.|||Coefficient of Determination|||Number
1390753|NCT01349920|Primary|Change From Baseline in REG3-A at Week 22|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for REG3-A at both baseline and at Week 22.|||ng/mL||Standard Deviation|Mean
1390754|NCT01349920|Primary|Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for REG3-A at both baseline and at Week 6.|||ng/mL||Standard Deviation|Mean
1390755|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 22|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for lipocalin-2 at both baseline and at Week 22.|||ng/mL||Standard Deviation|Mean
1390756|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 6|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for lipocalin-2 at both baseline and at Week 6.|||ng/mL||Standard Deviation|Mean
1390757|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 22|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for calprotectin at both baseline and at Week 22.|||µg/g||Standard Deviation|Mean
1390758|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 6|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for calprotectin at both baseline and at Week 6.|||µg/g||Standard Deviation|Mean
1390759|NCT01349920|Primary|Change From Baseline in Serum hsCRP at Week 22|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for hsCRP at both baseline and at Week 22.|||mg/L||Standard Deviation|Mean
1390760|NCT01349920|Primary|Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for hsCRP at both baseline and at Week 6.|||mg/L||Standard Deviation|Mean
1390761|NCT01349920|Primary|Change From Baseline in CDEIS Blinded Score at Week 22|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 22|Participants who had a blinded CDEIS score at both baseline and at Week 22.|||Score on a scale||Standard Deviation|Mean
1390762|NCT01349920|Primary|Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 6|Participants who had a blinded CDEIS score at both baseline and at Week 6.|||Score on a scale||Standard Deviation|Mean
1390763|NCT01349907|Secondary|Change From Baseline in PQ-LES-Q Overall Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week. Item 15, the PQ-LES-Q overall score, observed OC, is a global assessment of overall quality of life, and ranges from 1 to 5, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390792|NCT01349816|Secondary|Peak Change From Baseline in FEV1|Peak change from baseline in FEV1 through 2 hours|Day 1|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
1390764|NCT01349907|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., health, mood or feelings); item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant, OC is the sum of the rating assigned to each of the first 14 items, and ranges from 14 to 70, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390765|NCT01349907|Secondary|Percentage of Participants With a CGAS Score of Equal or Greater Than 70|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The percentage of participants with a score of 70 or greater, representing normal to superior social functioning, is shown.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
1390766|NCT01349907|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). An improvement in function is represented by a change from baseline value that is positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390767|NCT01349907|Secondary|Percentage of Participants With Emergent Depression Based on CDRS-R|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Participants with a CDRS-R score of 40 or greater (whose baseline CDRS-R is less than 40) exhibit emergent depression, which is a strong indicator of the presence or potential for a major depressive disorder.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
1390768|NCT01349907|Secondary|Percentage of CDRS-R Responders|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. A CDRS-R responder experiences a 50% or more decrease from baseline in CDRS-R total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
1390769|NCT01349907|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7, and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390770|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)|The CGI-BP mania is a single value score OC for assessing mania, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390771|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)|The CGI-BP depression is a single value score OC for assessing depression, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390772|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)|The CGI-BP overall is a single value score OC for assessing overall bipolar illness, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390773|NCT01349907|Secondary|Time to Failure to Maintain Response in Y-MRS Total Score|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to failure is the number of days from first achieving a 50% or more decrease from baseline in Y-MRS total score to the first subsequent day of a less than 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment. Restricted to participants who were total Y-MRS 50% responders in base trial P06107.|||Days||95% Confidence Interval|Median
1390775|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Responders|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A Y-MRS responder experiences a 50% or more decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
1390776|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A remitter is a participant with a Y-MRS total score of 12 or lower.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
1390777|NCT01349907|Secondary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score|The Y-MRS assesses the severity of manic episodes by assigning a severity rating to each of 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight). Seven of the 11 items are rated on a scale of 0-4, and 4 of the items are rated on a scale of 0-8. The Y-MRS total score, observed cases (OC), the assessment closest to the scheduled assessment day within the allowed window, is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
1390778|NCT01349907|Primary|Number of Participants Who Experienced Clinical or Laboratory Adverse Events|A clinical or laboratory adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)|Participants who received at least one dose of trial medication, and were 17 years old or younger. One treated participant from the Placebo/Asenapine group, who was 18 years old, was excluded from this analysis.|||Participants|||Number
1390779|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity|||mIU/mL||95% Confidence Interval|Mean
1390780|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity|||mIU/mL||95% Confidence Interval|Mean
1390781|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity|||mIU/mL||95% Confidence Interval|Mean
1390782|NCT01349829|Secondary|Seroprotection at Month 7|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity|||percentage of participants||95% Confidence Interval|Number
1390783|NCT01349829|Secondary|Seroprotection at Month 6|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity|||percentage of participants||95% Confidence Interval|Number
1390784|NCT01349829|Primary|Seroprotection at Month 1|Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity|||percentage of participants||95% Confidence Interval|Number
1390785|NCT01349816|Secondary|Mean Evening Trough FEV1|Change from baseline in mean evening 12-hour post-dose trough FEV1|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
1390786|NCT01349816|Secondary|Peak Change From Baseline in IC|Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
1390787|NCT01349816|Secondary|FEV1 Through 6 Hours|Peak change from baseline in FEV1 through 6 hours|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
1390788|NCT01349816|Secondary|Morning Pre-dose FEV1|Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
1390789|NCT01349816|Secondary|Peak Change in IC|Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline|Day 1|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
1390790|NCT01349816|Secondary|At Least 12% Improvement in FEV1|Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline|Day 1|MITT Population|||Participants|||Number
1390791|NCT01349816|Secondary|Time to Onset of Action|At least 10% improvement in mean FEV1|Day 1|MITT Population|||Participants|||Number
1390793|NCT01349816|Primary|FEV1 AUC0-12|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).|Day 7|Modified Intent to Treat (MITT) Population is made of participants who completed both treatment periods and had Pre-dose Day 1 data for both and no protocol deviations believed to have a potential impact on efficacy results. Subjects must have had data for the given endpoint to be included.|||Liters||95% Confidence Interval|Least Squares Mean
1390794|NCT01349803|Secondary|Mean Change From Baseline in QTcF Interval|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, Day 7, and Day 14|Safety Population|||msec||Standard Deviation|Mean
1390795|NCT01349803|Secondary|Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Tachycardia episodes / hour||Standard Error|Mean
1390796|NCT01349803|Secondary|Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Bradycardia episodes / hour||Standard Error|Mean
1390797|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Supraventricular runs / hour||Standard Error|Mean
1390798|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Supraventricular couplets / hour||Standard Error|Mean
1390799|NCT01349803|Secondary|Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Supraventricular events / hour||Standard Error|Mean
1390800|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Ventricular runs / hour||Standard Error|Mean
1390801|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Ventricular couplets / hour||Standard Error|Mean
1390802|NCT01349803|Secondary|Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Ventricular events / hour||Standard Error|Mean
1390803|NCT01349803|Secondary|Change From Baseline in 24-Hour Minimum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
1390804|NCT01349803|Secondary|Change From Baseline in 24-Hour Maximum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
1390805|NCT01349803|Secondary|Change From Baseline in Night Time Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
1390806|NCT01349803|Secondary|Change From Baseline in Daytime Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
1390807|NCT01349803|Secondary|Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|24 hours|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
1390808|NCT01349803|Secondary|Change From Baseline in Mean FEV1 Trough|Trough FEV1 averaged over Day 7 and Day 14|Day 7 to Day 14|MITT - patients from the ITT population who completed at least one evaluable FEV1 spirometry assessment for baseline (pre-dose on Day 1) and had an evaluable FEV1 spirometry assessment on at least one of the following: Day 7 pre-dose or Day 14 pre-dose (or both).|||Liters||95% Confidence Interval|Least Squares Mean
1390809|NCT01349803|Primary|Change From Baseline in 24-Hour Mean Heart Rate Post-dose|The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).|14 days|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
1390810|NCT01349790|Secondary|Percentage of Participants Who Achieved a Platelet Count > 30x10^9/L|The percentage of participants who achieved a platelet count > 30x10^9/L within 1 and 2 days after infusion is reported.|Day 1 to Day 2|Safety set: All participants enrolled in the study who received at least part of 1 dose of NewGam.|||Percentage of participants|||Number
1390811|NCT01349790|Secondary|Bleeding Intensity|The percentage of participants with various intensities of overall bleeding, epistaxis (bleeding of the nose), oral bleeding, and skin bleeding graded as none, minor, mild, moderate, or severe at Baseline and Day 22 are reported.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants|||Number
1390941|NCT01347840|Primary|Resting Energy Expenditure|Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.|16 months||||units on a scale|||Number
1390812|NCT01349790|Secondary|Percentage of Responders Who Achieved a Normal Platelet Count|The percentage of responders who achieved a normal platelet count is presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1390813|NCT01349790|Secondary|Maximum Platelet Count|The maximum platelet count achieved during the study is presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.|||10^9 platelets/L||Standard Deviation|Mean
1390814|NCT01349790|Secondary|Platelet Count by Visit|The platelet count at each study visit are presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.|||10^9 platelets/L||Standard Deviation|Mean
1390815|NCT01349790|Secondary|Duration of a Complete Response|The duration of a complete response was defined as the time from when a complete response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.|||Days||95% Confidence Interval|Median
1390816|NCT01349790|Secondary|Duration of an Alternative Response|The duration of an alternative response was defined as the time from when an alternative response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.|||Days||95% Confidence Interval|Median
1390817|NCT01349790|Secondary|Duration of a Response|The duration of a response was defined as the time from when a response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.|||Days||95% Confidence Interval|Median
1390818|NCT01349790|Secondary|Time to a Complete Response|A study participant had a complete response if their platelets increased to ≥ 100x10^9/L, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.|||Days||95% Confidence Interval|Median
1390819|NCT01349790|Secondary|Time to an Alternative Response|A study participant had a response if their platelets increased to ≥ 30x10^9/L and to at least double the baseline platelet count, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.|||Days||95% Confidence Interval|Median
1390820|NCT01349790|Secondary|Time to a Response|A study participant had a response if their platelets increased to ≥ 50x10^9/L within 7 days after the first infusion, ie, by study Day 8.|Day 1 to Day 8|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.|||Days||95% Confidence Interval|Median
1390821|NCT01349790|Secondary|Percentage of Complete Responders Who Lost the Response|A complete responder who lost the response is a study participant who met the criterion for a complete response but who then deteriorated, ie, their platelet count decreased to < 100x10^9/L or bleeding occurred.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1390822|NCT01349790|Secondary|Percentage of Alternative Responders Who Lost the Response|An alternative responder who lost the response is a study participant who met the criterion for an alternative response but who then deteriorated, ie, their platelet count decreased to < 30x10^9/L, their platelet count decreased to less than double the baseline count, or bleeding occurred.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1390823|NCT01349790|Secondary|Percentage of Complete Responders|A complete responder is a study participant with an increase in platelets to ≥ 100x10^9/L, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants||95% Confidence Interval|Number
1390824|NCT01349790|Secondary|Percentage of Alternative Responders|An alternative responder is a study participant with an increase in platelets to ≥ 30x10^9/L and to at least double the baseline platelet count, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants||95% Confidence Interval|Number
1390825|NCT01349790|Primary|Percentage of Responders|A responder is a study participant with an increase in platelets to ≥ 50x10^9/L within 7 days after the first infusion, ie, by study Day 8.|Day 1 to Day 8|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants||95% Confidence Interval|Number
1390942|NCT01347840|Primary|Percent Excess Weight Loss|Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.|16 months||||percentage of excess weight|||Number
1390826|NCT01349660|Secondary|Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability|Defined as the number of participants with treatment-emergent grade 3/4/5 adverse events/serious adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.03|every 4 weeks for up to 5.2 years|Includes all participants that received at least one dose of study treatment|||Participants|||Count of Participants
1390827|NCT01349660|Secondary|Median Overall Survival (OS) in Phase II Participants - Prior Bevacizumab and Bevacizumab Naive|Two groups of patients in the Phase II trial will be considered separately, 1) participants who have not received previous bevacizumab and 2) participants who have received bevacizumab as part of first-line treatment. Overall survival is measured as the interval from first study treatment until date of death, or date last known alive.|every 12 weeks for up to 60 months|Participants that have received at least one dose of study treatment|||months||95% Confidence Interval|Median
1390828|NCT01349660|Secondary|Overall Response (CR or PR) of Phase II Participants - Prior Bevacizumab and Bevacizumab Naive|Two groups of participants in the Phase II trial will be considered separately, 1) those who have not received previous bevacizumab and 2) those who have received bevacizumab as part of first-line treatment. Overall Response (OR) = number of patients with complete or partial responses (CR or PR) per McDonald or RANO criteria. McDonald: CR as disappearance of all disease for at least four weeks, no new lesions, no steroids; PR as 50% or greater decrease in the sum of all lesions compared with baseline for at least four weeks, no new lesions, stable or reduced steroids (McDonald 1990). RANO: CR as disappearance of all disease for at least 4 weeks, no new lesions, stable or improved nonenhancing lesions, and no steroid usage; and PR as a 50% or greater decrease in the sum of all lesions compared with baseline measurement for at least four weeks, no new lesions, stable or improved nonenhancing lesions on same or lower steroid dose compared to baseline (Wen 2010).|every 8 weeks, projected 24 months|Includes participants in Phase II that receive at least one study treatment and have at least one post-baseline disease assessment.|||Participants|||Count of Participants
1390829|NCT01349660|Primary|Median Progression-Free Survival (PFS) in Phase II Participants - Prior Bevacizumab and Bevacizumab Naive|Two groups of patients in the Phase II trial will be considered separately, 1) participants who have not received previous bevacizumab and 2) participants who have received bevacizumab as part of first-line treatment. PFS is measured from the date of first protocol treatment until date of disease progression or death occurs, or date of last adequate tumor assessment using RANO or McDonald criteria. McDonald disease progression criteria: a 25% or greater increase in sum of the diameters of lesions, new lesions, or clinical deterioration (McDonald et al, 1990). RANO disease progression criteria: a 25% or greater increase in the enhancing lesions sum compared with smallest tumor measurement, significant increase in T2/FLAIR nonenhancing lesion on stable or increasing corticosteroids, new lesions, or clinical deterioration (Wen et al 2010)|every 8 weeks for up to 33 months|All Phase II patients receiving at least one dose of study treatment that have had at least one post-baseline disease assessment|||months||95% Confidence Interval|Median
1390830|NCT01349660|Primary|Number of Phase I Patients Receiving 60mg or 80mg BKM120 Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage|The optimal dose of BKM120 to administer in combination with standard dose bevacizumab determined as the dose at which ≤1 of 6 patients experiences a DLT assessed using NCI CTCAE v4.03 during Cycle 1 (28 days). The optimal dose of BKM120 was determined to be 60 mg by mouth (PO), once a day for each 28 day cycle along with bevacizumab, administered 10 mg/kg intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.|Collected from day of first dose to the end of the first treatment cycle, up to 28 days|Includes all Phase I patients receiving assigned study dosing.|||Participants|||Count of Participants
1390831|NCT01349595|Primary|The Incidence of a Combined Endpoint of Death-censored Graft Loss or Greater Than 50% Reduction in Estimated Glomerular Filtration (eGFR) in Study Subjects.||60 months after enrollment in the study|Results data for zero participants were analyzed; long-term follow-up evaluation of participants was not possible due to discontinuation of funding.||||||
1390832|NCT01349491|Primary|Primary Outcome - Number of Participants With Atrial Fibrillation|To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.|6 months||||participants|||Number
1390833|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."|||Percentage of participnats|||Number
1390834|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."|||Percentage of participants|||Number
1390835|NCT01349465|Secondary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability||End of study (at month 36)||||Participants|||Number
1390836|NCT01349465|Secondary|Percentage of Participants With Late Viral Relapse|Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.|End of study (at month 36)|Late viral relapse was evaluated in all enrolled participants with SVR at LPVPS.|||percentage of participants|||Number
1390994|NCT01347086|Secondary|Tmax of BI 208333 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) .|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
1390837|NCT01349465|Primary|Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of participants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."|||Percentage of participants|||Number
1390838|NCT01349465|Primary|Percentage of Participants Maintaining SVR at the Last Available Visit|The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).|Last Available Visit (Month 36 for subjects completing the study)|All participants with SVR at LPVPS were included in the population analysis set.|||Percentage of participants||95% Confidence Interval|Number
1390839|NCT01349231|Secondary|Depression Symptoms|We will examine change from baseline in Hamilton Rating Scale for Depression (HRDS) ratings of depression severity at day 1-3 following a single ketamine infusion. The HRDS assesses severity of, and change in, depressive symptoms. The HRDS is a 21 item scale with scores ranging from 0-66. The higher the score, the more severe the depression.|Baseline, Day 1, Day 2, and Day 3||||units on a scale||Standard Deviation|Mean
1390840|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 3 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 3 days following infusion||||units on a scale||Standard Deviation|Mean
1390841|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 2 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 2 days following infusion||||units on a scale||Standard Deviation|Mean
1390842|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 1 day following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 1 day after ketamine infusion||||units on a scale||Standard Deviation|Mean
1390843|NCT01349192|Secondary|Pulmonary Exacerbations|Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.|28 days|Intention to treat|||Participants|||Count of Participants
1390844|NCT01349192|Secondary|Antibiotic Use (Days of Use Per Subject)|Days of use of oral, inhaled, and IV antibiotics over the 6 month study.|6 months|Intention to treat|||days||Standard Deviation|Mean
1390845|NCT01349192|Secondary|Antibiotic Use (Proportion of Subjects)|Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.|6 months|Intention to treat|||Participants|||Count of Participants
1390846|NCT01349192|Primary|MRSA Culture Status|Proportion of subjects with a negative culture for MRSA at Day 28.|Day 28|The analysis population is defined as all of the participants who were randomized to a study arm and were assessed for the primary microbiologic efficacy endpoint at both baseline and Day 28.|||Participants|||Count of Participants
1390847|NCT01349114|Secondary|Mean Central Aortic Pressure at 3 Months|Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)|3 months after start of study|Aortic pressure indicates the augmentation pressure (AP) in mmHg derived from the radial artery waveform.|||mm Hg||Standard Deviation|Mean
1390848|NCT01349114|Primary|Change in Flow-mediated Dilation|Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion|Baseline to 3 months||||percentage of flow-mediated dilation||Standard Deviation|Mean
1390849|NCT01348854|Secondary|Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)||6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.|||percentage of eyes|Participants||Number
1390850|NCT01348854|Primary|Reduction of Astigmatism|Reduction of astigmatism as determined by manifest refractive cylinder|6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.|||diopter|Participants|Standard Deviation|Mean
1390851|NCT01348789|Secondary|Hair Clearance|Hair Clearance = the percent of hair cleared from baseline to follow up|8 weeks after last treatment||||%baseline hair count|Participants|Standard Deviation|Median
1390852|NCT01348789|Secondary|Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.|Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)|0, 3, 7 days (after treatment #1, #2, and #3 respectively)||||number of areas|Participants||Number
1390881|NCT01348165|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
1390853|NCT01348789|Primary|Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.|"The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes:~Presence of transient (disappearing < 24 hours) or prolonged erythema~Presence of transient (disappearing < 24 hours) or prolonged edema~Self-limited bleeding from mechanical shaving~Blister formation~Ulcer formation~Pigment changes (hypo/hyper)~Textural changes~Scarring~Infection~Pruritis~Post inflammation reactions~Allergic reaction~The safety of the device will be confirmed if no device related serious adverse event will occur."|Up to 3 months|Intention to treat analysis - all participants that received at least 1 treatment.|||percentage of particpants||95% Confidence Interval|Number
1390854|NCT01348776|Secondary|Subject Satisfaction|Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.|5 months (final follow up)|Two subjects did not report on satisfaction.|||participants|||Number
1390855|NCT01348776|Secondary|Tolerability Level of the Procedure Following Treatments|"Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]) .~The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated."|1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)||||% treated areas|Participants||Number
1390856|NCT01348776|Secondary|Occurrence of Anticipated Effects on Skin|As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.|Up to 19 weeks||||Number of reports|Participants||Number
1390857|NCT01348776|Secondary|Hair Clearance at 3-month (Final) Follow up|Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.|5 months (3 months after 7 weekly treatments)|All areas with photos that allowed reliable hair counting were included for this analysis.|||%baseline hair count|Participants|Standard Error|Mean
1390858|NCT01348776|Primary|Hair Clearance 1 Month After Last Treatment|Hair clearance = the percent of hair cleared from baseline to endpoint.|3 months (1 month after 7 weekly treatments)|Sample size was discussed with the FDA during a pre-IDE meeting.|||%baseline hair count|Participants|Standard Deviation|Mean
1390859|NCT01348607|Secondary|Adverse Events|Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.|29 days||||events|||Number
1390860|NCT01348607|Primary|Average Daytime Napping Minutes in a Week|Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries|29 days||||minutes||Standard Deviation|Mean
1390861|NCT01348425|Primary|Percent Change in Stent Length Upon Deployment||During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)||||Change in stent length (%)||Standard Deviation|Mean
1390862|NCT01348347|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz) of Volasertib (BI 6727)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point (AUC0-tz) of Volasertib (BI 6727).|PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1390863|NCT01348347|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) of Volasertib (BI 6727)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of Volasertib (BI 6727).|PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1390864|NCT01348347|Secondary|Cmax of Volasertib (BI 6727)|Maximum concentration of an analyte in plasma|Pharmacokinetic (PK) plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1390865|NCT01348347|Secondary|Disease Control Rate According to RECIST v1.1|Disease control rate according to RECIST v1.1 - Unconfirmed disease control. The patients with complete response (CR), partial response (PR) or stable disease (SD).|6 months|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||Participants|||Number
1390866|NCT01348347|Secondary|Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1|Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1: Unconfirmed objective response. The patients with complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||Participants|||Number
1390867|NCT01348347|Primary|Maximum Tolerated Dose (MTD) of Volasertib|Maximum tolerated dose (MTD) of volasertib was the highest dose tested at which DLT was developed in not more than 1 of 6 patients in the course 1.|21 days|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||mg|||Number
1390936|NCT01347840|Secondary|Area Under the Curve of Glucose|This variable will measure the combined effects of glucose concentration and duration.|16 months||||units on a scale|||Number
1390868|NCT01348347|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).|"The following drug-related adverse events (AE) were defined as DLT;~Haematological toxicities: CTCAE(Common Terminology Criteria for Adverse Events) grade 4 neutropenia persisted for 7 or more days, CTCAE grade 4 thrombocytopenia or CTCAE grade 3 thrombocytopenia requiring blood transfusion.~Non-haematological toxicities: CTCAE grade ≥3 non-haematological toxicities. The following toxicity with neutropenia was defined as DLT.- CTCAE grade 3 febrile neutropenia persisted for over 2 days, Clinically significant laboratory abnormalities of CTCAE grade ≥3 persisted for over 3 days. The following laboratory abnormalities should be defined as DLT. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): >5.0 × ULN persisted for 7 days or longer - Creatinine: >3.0 × upper limit of normal(ULN) (if the creatinine abnormality was observed even once) - Persistent electrolyte abnormality assessed by the investigator."|21 days|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||Participants|||Number
1390869|NCT01348165|Primary|Assessment of Tolerability by Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories ‘good’, ‘satisfactory’, ‘not satisfactory’, and ‘bad’.|28 days|Treated Set|||Participants|||Number
1390870|NCT01348165|Primary|Body Temperature|Change from baseline to 28 Days in Body temperature|Baseline and 28 days|Treated Set|||degrees celcius||Standard Deviation|Mean
1390871|NCT01348165|Secondary|Minimum Effect (Emin)|Minimum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1390872|NCT01348165|Secondary|Maximum Effect (Emax)|Maximum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1390873|NCT01348165|Secondary|Area Under the Effect Curve (AUEC)|Area under the effect curve for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. Geometric mean and geometric coefficient of variation was not calculated for any parameter in any dose group in which zero or a negative value was calculated, as geometric means cannot be calculated with negative or zero values.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1390874|NCT01348165|Secondary|Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.|Percent of inhibition of fMLP induction of LTB4 production. Concentrations of LTB4 in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Results indicate percent change from baseline of fMLP induction of LTB4 production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||percentage of LTB4 production||Standard Deviation|Mean
1390875|NCT01348165|Secondary|Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo|Concentrations of TNF-α in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Concentrations of TNF-α in blood drawn after treatment with BI 137882 were compared with those in pre-dose samples to calculate the percent of inhibition of LPS induction of TNF-α production. Results indicate percent change from baseline of LPS-induced TNF-α production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||percentage of TNF-α production||Standard Deviation|Mean
1390876|NCT01348165|Secondary|Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2|Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.||||||
1390877|NCT01348165|Secondary|Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2|Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.||||||
1390878|NCT01348165|Secondary|Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2|Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.||||||
1390879|NCT01348165|Secondary|Apparent Volume of Distribution (Vz/F)|Apparent volume of distribution of the analyte during the terminal phase.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||L||Geometric Coefficient of Variation|Geometric Mean
1390880|NCT01348165|Secondary|Apparent Clearance (CL/F)|Apparent clearance of the analyte in plasma after extravascular administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1390937|NCT01347840|Secondary|Subject Questionnaires|The subscales and total scores as set out in the scoring algorithms for Food Craving Inventory-II and Questionnaire on Craving for Sweet and Rich Foods will be presented.|16 months||||participants|||Number
1390882|NCT01348165|Secondary|Terminal Rate Constant (λz)|Terminal rate constant in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1390883|NCT01348165|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1390884|NCT01348165|Secondary|Terminal Half-life (t1/2)|Terminal half-life of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
1390885|NCT01348165|Secondary|Area Under the Curve 0 to Infinity (AUC0-infinity)|Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1390886|NCT01348165|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration of the analyte in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||hours||Full Range|Median
1390887|NCT01348165|Secondary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1390888|NCT01348165|Primary|Respiratory Rate (RR)|Change from Baseline to 28 Days in Respiratory rate (RR)|Baseline and 28 days|Treated Set|||breaths/min||Standard Deviation|Mean
1390889|NCT01348165|Primary|Pulse Rate (PR)|Change from Baseline to 28 Days in Pulse Rate|Baseline and 28 days|Treated Set|||bpm||Standard Deviation|Mean
1390890|NCT01348165|Primary|Blood Pressure|Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Baseline and 28 days|Treated Set|||mmHg||Standard Deviation|Mean
1390891|NCT01348165|Primary|Number of Subjects With Drug Related Adverse Events|Number of subjects with drug related adverse events (AEs)|From baseline up to 28 days|Treated Set which included all subjects who received one dose of trial medication|||Participants|||Number
1390892|NCT01348139|Secondary|t1/2 :Terminal Half-life|Terminal half-life (t1/2),for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||Hours||Standard Deviation|Mean
1390893|NCT01348139|Secondary|Tmax:Time to Maximum Plasma Concentration|Time to maximum plasma concentration (tmax), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||Hours||Full Range|Median
1390894|NCT01348139|Secondary|AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),|Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||nmol*h/L||Standard Deviation|Mean
1390895|NCT01348139|Secondary|Cmax: Maximum Plasma Concentration|Maximum plasma concentration (Cmax) for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||nmol/L||Standard Deviation|Mean
1390896|NCT01348139|Secondary|E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit|Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set|||Beats/min||Standard Deviation|Mean
1390897|NCT01348139|Secondary|Emax: Maximum Value of Pulse for Every Treatment Visits|Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set|||Beats/min||Standard Deviation|Mean
1390898|NCT01348139|Secondary|E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit|Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.|0 - 24 hrs|PD analysis set|||Liters||Standard Deviation|Mean
1390899|NCT01348139|Secondary|E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.|Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.|FEV1 at 5 min|PD analysis set|||Liters||Standard Deviation|Mean
1390900|NCT01348139|Secondary|tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit|Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.|0 - 24 hrs.|PD analysis set|||Hours||Full Range|Median
1390901|NCT01348139|Primary|E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit|Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.|22-26 hrs.|PD analysis set|||Liters||Standard Deviation|Mean
1390902|NCT01348139|Primary|Emax: Maximum Value of FEV1 for Every Treatment Visits|Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.|0-24 hrs||||Liters||Standard Deviation|Mean
1390903|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone Divided by Dose - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL/mg||Standard Deviation|Mean
1390904|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng*h/mL||Standard Deviation|Mean
1390905|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
1390906|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||hours||Full Range|Median
1390907|NCT01348100|Secondary|Duration That the Concentration of Iloperidone Was Above 4 ng/mL (Teff) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The duration that the concentration of iloperidone was above 4 ng/mL was calculated by linear interpolation. PK/pharmacodynamic analysis performed in other studies suggests that iloperidone plasma levels of 4 ng/mL or above provide clinical efficacy.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||hours||Full Range|Median
1390908|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
1390909|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng*h/mL||Standard Deviation|Mean
1390910|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng*h/mL||Standard Deviation|Mean
1390911|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
1390912|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||hours||Full Range|Median
1390913|NCT01348100|Primary|The Average Plasma Concentration (Cav) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
1390914|NCT01348100|Primary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||Ratio of Cmax to Cav||Standard Deviation|Mean
1390938|NCT01347840|Secondary|Adiponectin and Lectin|These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.|16 months||||units on a scale|||Number
1390915|NCT01348087|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).|Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which patients entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study. AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 patients are shown under (‘Prior to Ext. first dose’). AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure|||Participants|||Number
1390916|NCT01347931|Secondary|Borg Dyspnea Score|"Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from:~0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome"|Measured during activity testing in a single day study visit|Per Protocol|||units on a scale||95% Confidence Interval|Median
1390917|NCT01347931|Secondary|Arterial Oxygen Saturation|O2 saturation measured by pulse oximetry|Measured during activity testing in a single day study visit|Per Protocol|||percentage of oxyHb saturation||Standard Deviation|Mean
1390918|NCT01347931|Primary|Activity Endurance Time|Time in minutes of sustained activity while using test treatments|Measured during single day study visit|Per Protocol|||minutes||Standard Deviation|Mean
1390919|NCT01347879|Secondary|Severe and Very Severe Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.|||participants|||Number
1390920|NCT01347879|Secondary|Mild and Moderate Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.|||participants|||Number
1390921|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.|||participants|||Number
1390922|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.|||participants|||Number
1390923|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment||||participants|||Number
1390924|NCT01347879|Secondary|Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after first treatment||||percent change||Full Range|Median
1390925|NCT01347879|Secondary|Clear and Almost Clear Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.|||participants|||Number
1390926|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment||||participants|||Number
1390927|NCT01347879|Secondary|Number of Patients With Adverse Events.||From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration||||participants|||Number
1390928|NCT01347879|Secondary|Pain During Illumination.|Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.|Immediately after first treatment||||VAS score in cm||Full Range|Mean
1390929|NCT01347879|Secondary|Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.|One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.|From baseline to 12 weeks after first treatment||||participants|||Number
1390930|NCT01347879|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.||From baseline to 12 weeks after the first treatment||||percent change||Full Range|Median
1390931|NCT01347879|Secondary|Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after the first treatment||||lesion count||Standard Deviation|Mean
1390932|NCT01347879|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).||From baseline to 12 weeks after first treatment||||lesion count||Standard Deviation|Mean
1390933|NCT01347840|Secondary|Percent Weight Loss|(Weight at Baseline – Weight at Each Visit) divided by the (Weight at Baseline).|16 Months||||percentage of weight loss|||Number
1390934|NCT01347840|Secondary|Body Mass Index|Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.|16 Months||||units on a scale|||Number
1390935|NCT01347840|Secondary|Hemoglobin A1c and Lipid Panel|These laboratory values will be collected at Screening, Visit 8, and Visit 10.|16 months||||units on a scale|||Number
1390943|NCT01347788|Primary|Partial Response in Bone Scan From Baseline to Week 6|Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.|Baseline and Week 6||||participants|||Number
1390944|NCT01347762|Secondary|Change From Baseline in Neuropsychological Performance at 10 Weeks|performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner|baseline and 10 weeks|Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.||||||
1390945|NCT01347762|Secondary|Change From Baseline Cannabis Use at 14 Weeks|quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)|baseline and 14 weeks|Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure.|||Ratio||Standard Deviation|Mean
1390946|NCT01347762|Secondary|Change From Baseline Neuropsychological Performance at 4 Weeks|performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner|baseline and 4 weeks|Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.||||||
1390947|NCT01347762|Primary|Number of Marijuana Inhales Per Day|Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.|Week 10|"Fewer participants had their average number of inhales per day analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure."|||Inhales per day||Standard Deviation|Mean
1390948|NCT01347762|Primary|Change From Baseline in Cannabis Use at 10 Weeks|Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)|baseline and 10 weeks|Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure.|||Ratio||Standard Deviation|Mean
1390949|NCT01347710|Secondary|Diagnostic Certainty in PET MPI and SPECT MPI|Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of patients|||Number
1390950|NCT01347710|Secondary|Image Quality of Rest and Stress (PET vs SPECT).|Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||percent of images|||Number
1390951|NCT01347710|Secondary|Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good|Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
1390952|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity|Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard|60 days|all safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data and had evaluable invasive coronary angiography|||Proportion of true negatives||95% Confidence Interval|Number
1390953|NCT01347710|Secondary|Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good|Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true positives||95% Confidence Interval|Number
1390954|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
1390955|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true positives||95% Confidence Interval|Number
1390973|NCT01347580|Primary|ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)|ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.|Between baseline and PCI|mITT, on patients with non missing values|||patients|||Number
1405606|NCT01215942|Secondary|Change From Baseline in Swollen Joint Count (66 Joint Count)||Baseline, 240 weeks|Zero participants analyzed. Swollen joint count data was not collected for analysis due to early termination of the study.||||||
1390956|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).|Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
1390957|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).|Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 Flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||Proportion of true positives||95% Confidence Interval|Number
1390958|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
1390959|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|"Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard~I"|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography|||proportion of true postives||95% Confidence Interval|Number
1390960|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity|Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||Proportion of true positive cases||95% Confidence Interval|Number
1390961|NCT01347632|Primary|p24 Antigen Production at Baseline Versus After Treatment With Metronidazole|p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.|30 days|||||||
1390962|NCT01347632|Primary|p24 Antigen Production in Tissue|"The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:~During a BV infection~Approximately 1 week after completing a 7-day course of metronidazole therapy~Approximately 1 month after completing the 7-day course of metronidazole therapy~Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected."|6 weeks|||||||
1390963|NCT01347580|Secondary|Minor and Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition)|after 48 hours post first dose|safety|||patients|||Number
1390964|NCT01347580|Secondary|Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition) include life threatening and other major bleedings|after 48hours post-first dose|safety|||patients|||Number
1390965|NCT01347580|Secondary|Minor and Major Bleedings Within 48 Hours|non CABG related bleeds (PLATO definition)|within 48 hours of first dose|Safety|||patients|||Number
1390966|NCT01347580|Secondary|Major Bleeds Within 48 Hours|non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds|within 48 hours of first dose|Safety|||patients|||Number
1390967|NCT01347580|Secondary|Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI|Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.|during PCI|mITT|||patients|||Number
1390968|NCT01347580|Secondary|ST Segment Elevation Resolution Post-PCI >= 70%|ST segment elevation resolution post PCI >=70% is defined as complete resolution|Between baseline and ECG 60 mn post-PCI|mITT on patients with non missing ECG values|||patients|||Number
1390969|NCT01347580|Secondary|TIMI Flow Grade 3 Post -PCI|TIMI) flow grade 3 is complete perfusion post-PCI.|at coroangiography post-PCI|mITT, on patients with non missing TIMI flow grade values|||patients|||Number
1390970|NCT01347580|Secondary|Definite Stent Thrombosis|Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint|during 30 days of treatment|mITT|||patients|||Number
1390971|NCT01347580|Secondary|2nd Composite Clinical Endpoint|Death/MI/urgent revascularization. Adjudicated events except death|within 30 days of study|mITT|||patients|||Number
1390972|NCT01347580|Secondary|1st Composite Clinical Endpoint|death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death|during the 30 days of treatment|mITT|||patients|||Number
1390993|NCT01347086|Secondary|Cmax of BI 208333 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (BI 208333).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
1390974|NCT01347580|Primary|Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)|(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.|At initial angiography, pre PCI|mITT, on patients with non missing values|||patients|||Number
1390975|NCT01347554|Secondary|Any Bleeding||Two year||||participants|||Number
1390976|NCT01347554|Secondary|Stent Thrombosis|Definite and probable stent thrombosis|Two years||||participants|||Number
1390977|NCT01347554|Secondary|Device-oriented Composite Outcome|defined as a composite of all-cause mortality, any MI (includes non-target vessel territory) and repeat revascularization (includes all target and non-target vessel)|Two years||||participants|||Number
1390978|NCT01347554|Primary|Device-oriented Composite Outcome|defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization|Two year||||participants|||Number
1390979|NCT01347255|Secondary|Changes in Total Skin Thickness|Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline|Baseline and Days 8, 15, 22, and 29.||||millimetres||Standard Deviation|Mean
1390980|NCT01347255|Secondary|Change From Baseline in Echo-poor Band Thickness at End of Treatment|Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound|Baseline and Day 29||||millimetres||Standard Deviation|Mean
1390981|NCT01347255|Secondary|Changes in Total Clinical Score (TCS) by Visit|Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.|Baseline and Days 4, 8, 11, 15, 18, 22, 25||||Scores on a scale||Standard Deviation|Mean
1390982|NCT01347255|Secondary|Change in Clinical Sign Scores|"Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline.~The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)).~Negative changes in mean score represent improvement."|Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)||||units on a scale||Standard Deviation|Mean
1390983|NCT01347255|Primary|Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline|TCS range from 0 (all signs absent) to 9 (all signs severe).|Day 1 (Baseline)/Day 29|Intra-individual analysis population|||Scores on a scale||Standard Deviation|Mean
1390984|NCT01347112|Secondary|Heavy Drinking Days at End of Treatment|Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method.|week 12||||days||Standard Deviation|Mean
1390985|NCT01347112|Secondary|Prolonged Abstinence at 24 Weeks|Prolonged abstinence is identified by a negative response to the question, “Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”|week 24||||participants|||Number
1390986|NCT01347112|Primary|Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment|"Prolonged smoking abstinence will be identified by a negative response to the question, Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”"|12 weeks||||participants|||Number
1390987|NCT01347086|Secondary|Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide).~The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
1390988|NCT01347086|Secondary|Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
1390989|NCT01347086|Secondary|AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168 Acylglucuronide) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg, Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1390990|NCT01347086|Secondary|Cmax of CD 6168 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
1390991|NCT01347086|Secondary|Tmax of CD 6168 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
1390992|NCT01347086|Secondary|AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1405607|NCT01215942|Secondary|Change From Baseline in Tender Joint Count (68 Joint Count)||Baseline, 240 weeks|Zero participants analyzed. Tender joint count data was not collected for analysis due to early termination of the study.||||||
1390995|NCT01347086|Secondary|AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (BI 208333) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1390996|NCT01347086|Secondary|Cmax of Deleobuvir|Maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
1390997|NCT01347086|Secondary|Tmax of Deleobuvir|Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
1390998|NCT01347086|Secondary|AUC0-∞ of Deleobuvir|Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration|The pharmacokinetic (PK) analysis set: all evaluable subjects of the treated set who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1390999|NCT01347086|Primary|Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|"Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint.~New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure)."|From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.|The treated set.|||participants|||Number
1391000|NCT01347086|Primary|Number of Subjects With Drug Related Adverse Events|"Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint.~The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history."|From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.|Treated set (full analysis set according to the International Conference on Harmonization (ICH) E9 guideline): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.|||Participants|||Number
1391001|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Safety Extension portion of the protocol ( please note: HPN-100 treatment only during Safety Extension )|12 months|All patients that entered the Safety Extension were included in the analysis of adverse events|||participants|||Number
1391002|NCT01347073|Secondary|Hyperammonemic Crisis|Rate of HAC during pre-enrollment on NaPBA compared to HAC during HPN-100 treatment|1 year||||number of crises|||Number
1391003|NCT01347073|Secondary|Frequency of Ammonia Levels Greater Than the Upper Limit of Normal (ULN) on HPN-100 Compared With NaPBA|Ammonia values were converted to SI units (umol/L) and normalized to a standard ULN of 35 umol/L prior to analysis|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.|||Ammonia Values > ULN|Ammonia Values||Number
1391004|NCT01347073|Secondary|Blood Ammonia|24-hour ammonia AUC of blood ammonia levels on Days 1 (NaPBA) and 10 (HPN-100) were compared. Ammonia was assessed at Hour 0 (pre-first dose, fasted), Hour 8 (~2-4 hours after lunch or the second main meal and dose of NaPBA), Hour 12 (~4 hours after the last main meal) and 24 hours post-first dose (pre-first dose on following day, fasted).|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.|||umol/L*hours||Standard Deviation|Mean
1391005|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Switch-Over portion of the Protocol|2 weeks|All patients who received any amount of study medication were included in this population, which is the primary population for all baseline, accountability, demographic and safety analyses.|||participants|||Number
1391006|NCT01347060|Secondary|Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant|The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.|||albuterol canisters||Standard Deviation|Mean
1391007|NCT01347060|Secondary|Mean Asthma-related Costs in the Post-index Period|Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.|||United States dollars||Standard Deviation|Mean
1391008|NCT01347060|Primary|Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims|Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.|||Asthma-related events||Standard Deviation|Mean
1391009|NCT01347034|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)|Evaluate the safety of intratumoral injections of DCs in combination with an intensified RT regimen patients with high-grade large STS. Toxicity assessments were performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention was paid to DC injection and biopsy related toxicity. Only treatment related SAEs and AEs are reported for this measure.|11 weeks per participant|All participants|||participants|||Number
1391010|NCT01347034|Primary|Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)|Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. Criteria for immune response evaluation: Individual patients were considered as responders to TAAs if at any time point the response in IFN-γ ELISPOT assay was found higher than 30 spots per 200,000 cells or in proliferation assay higher than 3000 counts/min (CPM) AND the response in IFN-γ ELISPOT or proliferation assays to tumor cell lysates (TCL) or Ad-Surv was found more than 2SD higher than the response to corresponding control lysate or Ad-c at the same time point AND 2SD higher than the response to the same stimuli at a base line (before start of the treatment).|11 weeks per participant|All participants|||participants|||Number
1391011|NCT01347008|Secondary|Daily Frequency of Raynaud's Phenomenon Attacks|Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit.|8 weeks||||number of attacks per day||Standard Deviation|Mean
1391012|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.||8 weeks||||perfusion units||Standard Deviation|Mean
1391013|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus|Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).|8 weeks||||perfusion units||Standard Deviation|Mean
1391014|NCT01346852|Secondary|Mean Number of Short-acting Beta-agonist (SABA) Canisters Used|The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=1 albuterol canister dispensed during the 12-month pre-index period.|||canisters||Standard Deviation|Mean
1391015|NCT01346852|Primary|Mean Ratio of Controller Medication to Total Asthma Medication|The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=5 albuterol canisters dispensed identified in the database during the 12-month identification period (pre-index). We tested 3 different capture/follow-up periods; thus, sample sizes varied depending capture period used.|||ratio||Standard Deviation|Mean
1391016|NCT01346839|Secondary|Trigger Positive Predictive Value|Positive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.|15 months||||Percentage of participants|||Number
1391017|NCT01346839|Secondary|Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation|Subsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.|15 months||||Number of patients diagnosed with cancer|||Number
1391018|NCT01346839|Secondary|Percentage of Cases With no Documented Justification for no Follow-up|This is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.|15 months||||percentage with no documentation|||Number
1391019|NCT01346839|Secondary|Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer|The percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.|15 months||||percentage of follow-up|||Number
1391020|NCT01346839|Primary|Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer|Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.|15 months||||Days||Inter-Quartile Range|Median
1391021|NCT01346774|Primary|Participants With Clinically-diagnosed and Treated UTI's.|The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records.|From surgery to post-op visit, approximately 6 weeks post surgery|Analysis was run on all 160 subjects that were ascribed to an arm of the study. Data were analyzed using an intent to treat protocol.|||participants||95% Confidence Interval|Number
1391022|NCT01346592|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).|Day 1 to Day 394|Analysis was done on the safety population i.e all subjects who had received at least one study vaccine and had postvaccination safety data|||Participants|||Number
1391023|NCT01346592|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination|The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.|Day 1 through Day 7 after any vaccination|Analysis was done on solicited safety set i.e all subjects who had received at least one study vaccine and had provided data on post vaccination solicited AEs|||Participants|||Number
1391024|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination|To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.|Day 1, Day 29|Analysis was done on the FAS (Persistence).|||Titers||95% Confidence Interval|Geometric Mean
1391025|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains|The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.|Day 50, Day 209|Subjects aged 6 through <72 months of age - Full Analyses Set (FAS) Persistence|||Percentage of subjects||95% Confidence Interval|Number
1391026|NCT01346592|Secondary|The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)|The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 50, Day 209|Analysis was done on the FAS Persistence|||Titers||95% Confidence Interval|Geometric Mean
1391027|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1391028|NCT01346592|Secondary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the Full Analysis Set.|||Percentages of subjects||95% Confidence Interval|Number
1391029|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.|Day 50|Analysis was done on the Per Protocol Set.|||Percentages of subjects||95% Confidence Interval|Number
1391030|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the PPS.|||Titers||95% Confidence Interval|Geometric Mean
1391031|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains|The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)|||Percentage of subjects||95% Confidence Interval|Number
1391032|NCT01346592|Secondary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group|The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)|||Percentage of subjects||95% Confidence Interval|Number
1391033|NCT01346592|Secondary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)|||Ratios||95% Confidence Interval|Geometric Mean
1391055|NCT01346488|Secondary|Number of Participants With Adverse Drug Reactions|Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.|up to Week 52|Safety Analysis Set (all evaluable participants with validated CRFs)|||Participants|||Count of Participants
1391034|NCT01346592|Secondary|The HI GMTs Against Homologous Strains, by Vaccine Group|The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence) i.e. all subjects in the enrolled population who actually received a study vaccination, and provided evaluable serum samples at all relevant timepoints and also at day 209.|||Titers||95% Confidence Interval|Geometric Mean
1391035|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS|||Percentage of subjects||95% Confidence Interval|Number
1391036|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the FAS|||Titers||95% Confidence Interval|Geometric Mean
1391037|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS|||Percentage of subjects||95% Confidence Interval|Number
1391038|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Full Analysis Set (FAS) i.e all enrolled subjects who received study vaccination and provided serum samples.|||Titers||95% Confidence Interval|Geometric Mean
1391039|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age|The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Subjects aged 6 through <36 months of age - Per Protocol Set (PPS).|||Percentage of subjects||95% Confidence Interval|Number
1391040|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)|The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to <36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the PPS.|||Titers||95% Confidence Interval|Geometric Mean
1391041|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains|"The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 50|Analysis was done on the PPS.|||Percentage of subjects||95% Confidence Interval|Number
1391042|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Per Protocol Set (PPS) i.e all subjects in the enrolled population who correctly received the study vaccine, provided evaluable serum samples at relevant time-points and had no major protocol violations as defined prior to unblinding.|||Titers||95% Confidence Interval|Geometric Mean
1391043|NCT01346514|Secondary|Treatment Process Measures (Number of Treatment Sessions, Type of Housing Placement, and Change in Life Skills)|Analyses will explore whether treatment process variables mediate differences in outcomes between Addiction/Housing Case Management and time and attention conditions.|Baseline to 12 months|Due to the lack of differences seen in the primary housing outcomes between the AHCM and HSG conditions, tests of mediation were not completed.||||||
1391044|NCT01346514|Secondary|Change in Mental Health Status in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved mental health outcomes, as measured by the Psychiatric Composite Score (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Mental Component Summary (MCS, range 0 to 100 with lower scores indicating greater severity) of the SF-36, among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI Psychiatric Composite Score indicates improvement. Positive change on the SF-36 MCS indicates improvement.|Baseline to 12 months||||units on a scale||95% Confidence Interval|Mean
1391045|NCT01346514|Secondary|Change in Percent of Participants Abstinent From Baseline to 12 Month Follow-up|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly increase the percent of participants abstinent from alcohol and drugs over the past 30 days among homeless Veterans entering addiction specialty care over the 12-month study course. Positive change indicates improvement.|Baseline to 12 months||||precentage of participants||95% Confidence Interval|Number
1391046|NCT01346514|Secondary|Change in Alcohol and Drug Outcomes in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved alcohol and drug outcomes, as measured by Alcohol and Drug Composite Scores (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI), among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI measures indicates improvement.|Baseline to 12 months||||units on a scale||95% Confidence Interval|Mean
1391047|NCT01346514|Secondary|Change in Functional Status in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved functional status outcomes among homeless Veterans entering addiction specialty care over the 12-month study course. Functional status was measured by Medical, Employment, Family/Social, and Legal Composite Scores (range 0 to 1 with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Physical Component Summary (PCS, range 0 to 100 with lower scores indicating greater severity) on the SF-36. Negative change on the ASI measures indicates improvement. Positive change on the SF-36 PCS indicates improvement.|Baseline to 12 months||||units on a scale||95% Confidence Interval|Mean
1391048|NCT01346514|Secondary|Costs and Cost-effectiveness of AHCM vs. HSG, Baseline to 12 Months|Costs and cost-effectiveness of Addiction/Housing Case Management to the Housing Support Group condition.|Baseline to 12 months|These analyses were not completed due to the lack of differences seen in the primary study outcomes (percent days housed) and quality of life measures (SF-36).||||||
1391049|NCT01346514|Primary|Percent Days Housed in AHCM vs. HSG, Baseline to 12 Months.|The primary aim is to determine whether the Addiction/Housing Case Management intervention increases percent days in long-term housing (permanent or long-term transitional) during the year following treatment entry relative to a Housing Support Group.|12 months (18 to 24 month outcomes examined in secondary analyses)|The percent of days in long-term transitional housing and/or own home was calculated for all patients using self-report and VA Homeless Operations Management and Evaluation System (HOMES) data. Individuals with no self-report or HOMES data were coded as not housed.|||percent days housed||95% Confidence Interval|Mean
1391050|NCT01346501|Secondary|Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions|Adverse drug reactions (serious and non-serious) are adverse events for which the causal relationship between adalimumab and the event could not be ruled out. Adverse event was defined as any untoward or unintended medical occurrences (including abnormal laboratory findings), signs/symptoms, or diseases of the participant receiving adalimumab, regardless of causality of adalimumab treatment. Data are presented as percentage of participants.|From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years|Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.|||Percentage of participants|||Number
1391051|NCT01346501|Secondary|Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5|The mTSS, a method of assessing radiographs, was used to evaluate the level of joint destruction by disease. Digitized X-rays of hands and feet were obtained and scored on a scale ranging from 0 [no damage] to 5 [complete collapse or total destruction of joint] for erosion and 0 [no damage] to 4 [complete luxation of joint] for joint space narrowing. The scores on each task were summed and averaged to derive the total mTSS score ranging from 0 [normal] to 380 [maximal disease]. Large positive change in mTSS indicated disease progression; small positive/no change indicated slowing/halting of disease progression. The mTSS score ≤ 0.5 was defined as minimal radiographic progression. Data are presented as the percentage of the participants with mTSS ≤ 0.5 and ≤ 1.5 at the end of third year of the observation period (at Week 104 of P12-707).|3 years|The effectiveness analysis set was defined as all participants who had evaluable mTSS score during studies P12-069 and P12-707.|||Percentage of participants|||Number
1391052|NCT01346501|Primary|Mean Health Assessment Questionnaire (HAQ) Score|The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable HAQ score during studies P12-069 and P12-707.|||Score on a scale||Standard Deviation|Mean
1391053|NCT01346501|Primary|Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)|MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level < 121 ng/mL in men and < 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable MMP-3 score during studies P12-069 and P12-707.|||Percentage of participants|||Number
1391054|NCT01346501|Primary|Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment|The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score <3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score < 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156|The effectiveness analysis set was defined as all participants who had evaluable DAS28-CRP score during studies P12-069 and P12-707.|||Percentage of participants|||Number
1391056|NCT01346488|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths|AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized.|up to Week 52|Safety Analysis Set (all evaluable participants with validated CRFs)|||Participants|||Count of Participants
1391057|NCT01346488|Secondary|Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable EQ-5D assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
1391058|NCT01346488|Secondary|Number of Participants Per Category of the CDAI|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Categories were defined as: high (> 22.1), moderate (≤ 22.0 to > 10.0), low (≤ 10.0 to < 2.8), and remission (≤ 2.8).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
1391059|NCT01346488|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
1391060|NCT01346488|Secondary|Number of Participants Per Category of the DAS28-4 ESR|DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
1391061|NCT01346488|Secondary|Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)|DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in scores indicates improvement of disease activity.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 ESR assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
1391062|NCT01346488|Secondary|Number of Participants Per Category of the DAS28-4 CRP|DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a VAS. The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
1391063|NCT01346488|Secondary|Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)|DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a visual analog scale (VAS). The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in score indicates improvement of disease activity.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
1391064|NCT01346488|Primary|Number of Participants Per Category of the HAQ-DI|The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (> 1.5), moderate (≤ 1.5 to > 1.0), low (≤ 1.0 to > 0.5), remission (≤ 0.5 to > 0), 0 (0).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
1391169|NCT01345630|Secondary|Number of Participants With Grade 3 or 4 AEs|Number of participants with grade 3 or 4 AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
1391065|NCT01346488|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
1391066|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA|Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of activity impairment||Standard Deviation|Mean
1391067|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA|The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)* [number of hours worked / (number of hours of work missed due to RA + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of OWPI||Standard Deviation|Mean
1391068|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)|Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of impairment while working||Standard Deviation|Mean
1391069|NCT01346488|Primary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)|Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100*number of hours of work missed due to RA / (number of hours of work missed due to RA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. “Change” was calculated as the value at baseline minus the value at each subsequent time point.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of work time missed||Standard Deviation|Mean
1391070|NCT01346475|Secondary|Duration of Genital HSV Shedding Episodes|Median duration of HSV shedding episodes, in hours, among episodes of known duration|11 weeks||||Hours|Episodes|Inter-Quartile Range|Median
1391071|NCT01346475|Secondary|Number of Genital HSV Shedding Episodes|The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs.|11 weeks||||Episodes|||Number
1391072|NCT01346475|Secondary|Quantity of HSV Detected, Median|Median quantity of HSV detected, among swabs with any HSV detected|11 weeks||||log 10 copies/ml|swabs|Inter-Quartile Range|Median
1391073|NCT01346475|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir.||11 weeks|Participants who collected at least one swab on each arm of the cross-over were included in the analysis.|||percentage of swabs with HSV detected|Swabs||Number
1391074|NCT01346410|Secondary|Late Toxicity Rate|Toxicities will be graded using CTCAE criteria at specified timepoints.|5 years|||||||
1391075|NCT01346410|Primary|Local Control Rate|Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.|5 years||||Participants|||Count of Participants
1391076|NCT01346397|Primary|Graft Survival|in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%|5 years||||percentage of participants||95% Confidence Interval|Number
1391077|NCT01346397|Primary|Patient Survival|in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%|5 years||||percentage of participants||95% Confidence Interval|Number
1391170|NCT01345630|Secondary|Frequency of Adverse Events (AE).|Number of participants with treatment-emergent non serious AEs|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
1391078|NCT01346293|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference >50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 28 post-final vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1391079|NCT01346293|Other Pre-specified|Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1391080|NCT01346293|Other Pre-specified|Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1391081|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1391082|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1391083|NCT01346293|Primary|Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1391084|NCT01346293|Primary|Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration <1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1391085|NCT01346293|Primary|Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1391086|NCT01346293|Primary|Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration <0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but <2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1391087|NCT01346293|Primary|Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1391088|NCT01346293|Primary|Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Booster responses to pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but <4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
1391089|NCT01346189|Secondary|Change in LDL From Baseline to 15 Months|Change in LDL-C levels (mg/dL) from baseline to 15 months|15 months||||mg/dL||95% Confidence Interval|Mean
1391090|NCT01346189|Primary|Change in LDL From Baseline to 12 Months|Change in LDL-C levels (mg/dL)|12 months|Subjects were lost to follow-up, or withdrawn for other reasons. Thus the number analyzed at the 12 month time point does not equal the number analyzed during baseline.|||mg/dL||95% Confidence Interval|Mean
1391091|NCT01346176|Secondary|Patient Satisfaction With Advance Care Planning.|Patients’ satisfaction with their advance care planning was assessed two months after they completed their ADs. One of two authors blinded to patients’ group assignments contacted patients by phone and administered a satisfaction survey based on the Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This thirteen-item questionnaire has been validated for assessing satisfaction with end-of-life care planning. Patients were asked to indicate satisfaction with various parts of advance care planning (e.g. decisions about the use of life sustaining technologies including CPR or cardiopulmonary resuscitation, breathing machines, and dialysis) on a scale from 1 to 5, where 1 means not at all satisfied and 5 means completely satisfied. The overall average across the 13 item scale in each group is presented in the results below.|Two months after AD completion|These numbers reflect the number of patients who completed and returned and advance directive as well as completed a satisfaction interview and questionnaire with a research associate.|||units on a scale||Full Range|Mean
1391092|NCT01346176|Primary|Proportion of Subjects Who Select Palliative Care Options|The primary outcome variable will be the proportion of subjects that select palliative care options compared to the those who request aggressive treatment in each study arm. We will analyze the effects of manipulating default options and delays in alerting subjects to the presence of multiple default options on each selection in the ADs in order to see how default options influence decisions on general treatment goals and instructions for specific procedures.|6 months|This number was based on the number of participants who returned completed advance directive forms in each group|||percentage who select palliative care||95% Confidence Interval|Number
1391093|NCT01346085|Secondary|Any Adverse Event Throughout Follow-up|Among study participants there were no reports of death, post-transplantation lymphoproliferative disease, cancer, or opportunistic infections. There was no evidence of cytomegalovirus disease, infection or serological activation (CMV early antigens negative during the whole follow-up), nor of Epstein–Barr clinical and serological reactivation (all patients were antibodies anti EBV positive before transplant, as per the inclusion criteria).|up to 3 years|||||||
1391094|NCT01346085|Secondary|Severe Hypoglycemic Events Since Completion of Transplant||up to 3 years|||||||
1391095|NCT01346085|Secondary|the Reduction in Insulin Requirement Compared to Baseline||up to 3 years|||||||
1391096|NCT01346085|Secondary|Basal and Stimulated Blood C-peptide Levels in Response to Arginine Challenge Throughout Follow-up||up to 3 year|||||||
1391097|NCT01346085|Secondary|Glycated Hemoglobin Levels Throughout Follow-up||up to 3 years|||||||
1391098|NCT01346085|Secondary|Insulin Independence With Adequate Glycemic Control Throughout Follow-up||up to 3 years||||participants|||Number
1391099|NCT01346085|Primary|The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion|Insulin independence is defined as no need for exogenous insulin, with adequate glycemic control [i.e., glycated hemoglobin <7% (normal range 3.5 - 6.0%), fasting glucose levels not exceeding 140 mg/dL (7.8 mmol/L) more than three times per week and 2-hour postprandial levels not exceeding 180 mg/dL (10 mmol/L) more than four times per week].|3 year||||participants|||Number
1391100|NCT01346072|Primary|Body Weight|Change in body weight from baseline to 24 hours after tolvaptan administration|Change over 24 hours|All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.|||Kg||Standard Deviation|Mean
1391101|NCT01346072|Primary|Urine Output|Total urine output for 24 hours following tolvaptan administration|24 hours|All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.|||mL||Standard Deviation|Mean
1391102|NCT01346059|Secondary|Need for Colectomy|Partial or complete colectomy performed within 30 days of enrollment|30 day||||Participants|||Count of Participants
1391103|NCT01346059|Secondary|Mortality|Death within 30 days of enrollment, in or out of hospital|30 day||||Participants|||Count of Participants
1391104|NCT01346059|Primary|Resolution of Diarrhea and White Blood Cell Count Elevation|If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.|14 days||||Participants|||Count of Participants
1391105|NCT01345929|Secondary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|ME: Treated patients, with baseline pathogen, complied with protocol.|||percentage of subjects|||Number
1391106|NCT01345929|Primary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|mMITT: Treated subjects, with baseline pathogen.|||percentage of subjects|||Number
1391107|NCT01345786|Secondary|Volume of Distribution (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||L|Participants|Standard Deviation|Mean
1391108|NCT01345786|Secondary|Clearance (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||L/h|Participants|Standard Deviation|Mean
1391332|NCT01343901|Secondary|Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period||Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Cycles||Standard Deviation|Mean
1391109|NCT01345786|Secondary|t1/2 of E2||0 hours to t1/2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Mean
1391110|NCT01345786|Secondary|Terminal Phase Half Life (t1/2) of NOMAC||0 hours to t1/2 (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Mean
1391111|NCT01345786|Secondary|Tmax of E2||0 hours to tmax of E2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Median
1391112|NCT01345786|Secondary|Tmax of NOMAC||0 hours to tmax of NOMAC (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Median
1391113|NCT01345786|Primary|Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~AUC72 is the AUC from time 0 to 72 hours.~Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to 72 hours|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||pg*h/mL|Participants|Full Range|Mean
1391114|NCT01345786|Primary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~AUClast is the AUC from time 0 to the time of the final quantifiable sample.~AUC infinity is the AUC from time 0 to infinity.~Blood samples for PK evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of the last measurable sample (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||ng*h/mL|Participants|Full Range|Mean
1391115|NCT01345786|Primary|Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to time of maximum observed serum concentration of E2 (tmax of E2) (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||pg/mL|Participants|Full Range|Mean
1391116|NCT01345786|Primary|Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~Blood samples for pharmacokinetic (PK) evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of maximum observed plasma concentration of NOMAC (tmax of NOMAC) (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||ng/mL|Participants|Full Range|Mean
1391117|NCT01345721|Secondary|Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination|The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.|Day 1-28 after vaccination|The analysis was done on the safety dataset.|||Participants|||Number
1391118|NCT01345721|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination|The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.|Day 1-7 after vaccination|The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data|||Participants|||Number
1394120|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1391119|NCT01345721|Secondary|Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset|||Titers||95% Confidence Interval|Geometric Mean
1391120|NCT01345721|Secondary|Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset|||Percentages of subjects||95% Confidence Interval|Number
1391121|NCT01345721|Primary|Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine|The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
1391122|NCT01345721|Primary|Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination|The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y|1 month after vaccination|The analysis was done on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
1391123|NCT01345721|Primary|Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination|The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.|1 month post booster vaccination|The analysis was done on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
1391124|NCT01345721|Primary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination|The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.|1 month post booster|The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.|||Percentages of subjects||95% Confidence Interval|Number
1391125|NCT01345721|Secondary|Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|From 13-33 months post last vaccination in parent study (V59P22)|The analysis was done on the per-protocol persistence dataset.|||Titers||95% Confidence Interval|Geometric Mean
1391126|NCT01345721|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|"The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported.~The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)"|From 13-33 months post last vaccination in parent study (V59P22)|The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.|||Percentages of subjects||95% Confidence Interval|Number
1391127|NCT01345682|Secondary|Time to Deterioration in Global Health Status|The time to deterioration was defined as the time from randomisation to a score decreased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS|||months||95% Confidence Interval|Median
1391128|NCT01345682|Secondary|Time to Deterioration in Swallowing|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS|||months||95% Confidence Interval|Median
1391129|NCT01345682|Secondary|Time to Deterioration in Pain|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS|||months||95% Confidence Interval|Median
1391130|NCT01345682|Secondary|Status Change in Global Health Status Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1391131|NCT01345682|Secondary|Status Change in Swallowing Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1391132|NCT01345682|Secondary|Status Change in Pain Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1391133|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||scores on a scale||Standard Error|Mean
1391134|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||scores on a scale||Standard Error|Mean
1391135|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||scores on a scale||Standard Error|Mean
1391136|NCT01345682|Secondary|Tumour Shrinkage|"Tumour shrinkage, defined as the maximum decrease from baseline in the sum of diameters of the target lesions, as measured by central imaging. The longest diameter of target lesions was recorded, except for lymph nodes, which were measured by their short axis.~Negative values indicate a reduction in the sum of target lesion diameters and positive values an increase.~Percentage of Participants with Tumour shrinkage as per the categories (>=20% increase, >=0 − <20% increase, >0 − <30% decrease, >=30 − <50% decrease, >=50% decrease) are presented."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1391137|NCT01345682|Secondary|Disease Control (DC)|"DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD.~CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis).~PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;~SD for TL: change in the sum of diameters does not satisfy PR or PD.~SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months|RS|||percentage of participants||95% Confidence Interval|Number
1391211|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. Results will be posted when they become available.|At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B™ and one month post the Month 50 booster dose of Engerix-B™||2017-12-31|12/2017||||
1391138|NCT01345682|Secondary|Objective Response (OR)|"OR is defined as the best overall response of complete response (CR) and partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis).~PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-Progressive Disease (PD) in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;~All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months|RS|||percentage of participants||95% Confidence Interval|Number
1391139|NCT01345682|Secondary|Overall Survival (OS)|Overall survival (OS) was a key secondary endpoint of this trial. OS was defined as the time from randomisation to death (irrespective of the cause of death). Patients for whom there was no evidence of death at the study completion date (06 December 2016) were to be censored on the date that they were last known to be alive.|From randomization until death or study completion date (06Dec2016); Up to 60 months|RS|||months||95% Confidence Interval|Median
1391140|NCT01345682|Primary|Progression-free Survival (PFS) Based on Central Independent Review|"PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the study completion date (06 December 2016).~The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied:~At least 20% increase in the Sum of Diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm~Appearance of one or more new lesions~Unequivocal progression of existing non-target lesions"|From randomization until disease progression, death or study completion date (06Dec2016); Up to 60 months|Randomised set (RS)|||months||95% Confidence Interval|Median
1391141|NCT01345669|Secondary|Health Related Quality of Life (HRQOL) Scores Over Time|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.|Baseline and 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Unit on Scale||Standard Error|Least Squares Mean
1391142|NCT01345669|Secondary|Time to Deterioration in Health Related Quality of Life (HRQOL)|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Months||Inter-Quartile Range|Median
1391143|NCT01345669|Secondary|Patients With Improved Health Related Quality of Life (HRQOL)|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Percentage of Patients|||Number
1391144|NCT01345669|Secondary|Percentage of Patient Deaths (Overall Survival (OS))|Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Percentage of patients|||Number
1391145|NCT01345669|Secondary|Disease Free Survival (DFS) Rate at 2 Years|Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.|Up to 2 years|Randomised Set, the number of patients from the randomized set those are disease free (or DFS) at 2 years.|||Probability (%)||95% Confidence Interval|Number
1391146|NCT01345669|Primary|Disease Free Survival (DFS)|Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Months||Inter-Quartile Range|Median
1391147|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)|Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||pg/mL||Standard Deviation|Mean
1391148|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin|Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||ng/mL||Standard Deviation|Mean
1391249|NCT01344759|Secondary|Needed Artificial Airway|This is the count of the number of patients who needed an artificial airway.|During MRI and until recovery room discharge - approximately 30-250 minutes||||Number of artifical airway events|||Number
1391149|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||g/cm^2||Standard Error|Least Squares Mean
1391150|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||g/cm^2||Standard Error|Least Squares Mean
1391151|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||g/cm^2||Standard Error|Least Squares Mean
1391152|NCT01345630|Secondary|Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
1391153|NCT01345630|Secondary|Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||gram||Standard Error|Least Squares Mean
1391154|NCT01345630|Secondary|Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48|The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||Ratio||Standard Deviation|Mean
1391155|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)|The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||Percentage of lymphocytes||Standard Deviation|Mean
1391156|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)|The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||cell/mm^3||Standard Deviation|Mean
1391157|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)|The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||Percentage of lymphocytes||Standard Deviation|Mean
1391158|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)|The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||cell/mm^3||Standard Deviation|Mean
1391250|NCT01344759|Secondary|Respiratory Disturbance Index|The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.|During MRI and until recovery room discharge - approximately 30-250 minutes||||respir.disturbance events/hr of sleep||Inter-Quartile Range|Mean
1391159|NCT01345630|Secondary|Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria|For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI’s were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. The assessment was performed using the overall (ie. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15 for the MVC+DRV/r arm and 3 for the FTC/TDF+DRV/r arm.|||participants|||Number
1391160|NCT01345630|Secondary|Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.|For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.|||participants|||Number
1391161|NCT01345630|Secondary|Tropism Change Between Screening or Baseline and PDTF|For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF.|Week 48|Number of Evaluable PDTF = Virology Analysis Population (VAP) 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).|||participants|||Number
1391162|NCT01345630|Secondary|Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).|Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012).|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. No imputation for missing values was performed for this endpoint. 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).|||Number of participants|||Number
1391163|NCT01345630|Secondary|The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).|The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA’s Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.|||proportion of participants|||Number
1391164|NCT01345630|Secondary|Severity of Abnormal Laboratory Values|Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
1391165|NCT01345630|Secondary|Number of Participants With Abnormal Laboratory Values|Number of participants with laboratory abnormalities are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. One participant was not analyzed for laboratory data as the collection date for all lab data was less than the first active therapy date.|||participants|||Number
1391166|NCT01345630|Secondary|Number of Participants With Treatment-emergent Serious Adverse Events|Total number of participants with treatment-emergent serious adverse events are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
1391167|NCT01345630|Secondary|Number of Treatment-related AEs|Number of treatment-related AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||events|||Number
1391168|NCT01345630|Secondary|Number of Participants Who Discontinued Due to AEs|Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
1391171|NCT01345630|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.|The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure.|Week 48|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of the study drug. The missing value was imputed per FDA’s MSDF Snapshot algorithm as described under “Outcome Measure Description” above.|||Percentage of participants|||Number
1391172|NCT01345591|Secondary|SWAP, COPE and CSQ-8|three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction.|as assessed at baseline, 7-21 days, 3 months and 9 months post op.||||units on a scale||Standard Deviation|Mean
1391173|NCT01345591|Primary|Volume|fat graft volume|3 months and 9 months post op.||||milliliters||Standard Deviation|Mean
1391174|NCT01345318|Primary|Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)|Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs.|At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.|The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.|||percentage of participants|||Number
1391175|NCT01345318|Primary|Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.|Baseline up to Week 48|The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.|||participants|||Number
1391176|NCT01345292|Secondary|Global Subjective VAS Score at Week 4|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1391177|NCT01345292|Secondary|Global Subjective VAS Score at Week 2|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1391178|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1391179|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1391180|NCT01345292|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1391181|NCT01345292|Secondary|Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1391182|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
1391183|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
1391184|NCT01345253|Secondary|Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks.|Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|52 weeks|MITT Population|||Days||Inter-Quartile Range|Median
1391185|NCT01345253|Secondary|Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks.|Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compaired between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.|Week 52|MITT Population|||Days||Inter-Quartile Range|Median
1391186|NCT01345253|Secondary|Percent of Participants With SRI7 Response at Week 52.|SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of participants|||Number
1391187|NCT01345253|Secondary|Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.|The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1391251|NCT01344759|Secondary|Obstructive Index Until Recovery Room Discharge|The Obstructive Index is a count of the obstructive apnea events per hour of sleep|During MRI and until recovery room discharge - approximately 30-250 minutes||||Apnea events/hour of sleep||Inter-Quartile Range|Mean
1391431|NCT01342770|Secondary|Post-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Time of surgery, after 42 days of treatment|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained|||SUV||Full Range|Median
1391188|NCT01345253|Primary|Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52.|SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Week 52|Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.|||Percentage of participants|||Number
1391189|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|Up to Study End at Month 51||2017-12-31|12/2017||||
1391190|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391191|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391192|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391193|NCT01345240|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B™|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391194|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|Up to Study End at Month 51||2017-12-31|12/2017||||
1391195|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391252|NCT01344759|Primary|Cross Sectional Area of the Pharyngeal Airway|The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.|during MRI within first 10 minutes of scanning||||mm^2||95% Confidence Interval|Median
1391196|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 to Month 8.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391197|NCT01345240|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391198|NCT01345240|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B™ (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B™ vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1391199|NCT01345240|Secondary|Anti-Rotavirus (Anti-RV) Antibody Concentrations|Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix™ as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Rotarix™. Results presented are for the study groups pooled by RTS,S or Engerix-B™ vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.|At Month 3, aka one month post Dose 2 of Rotarix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||U/mL||95% Confidence Interval|Geometric Mean
1391200|NCT01345240|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT)|The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL.|At Day 0 and at Month 3 (one month post Dose 3 of Infanrix™-Hib)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1391201|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. .|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1391202|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1391253|NCT01344629|Secondary|MRTpo|mean residence time of Telmisartan in the body after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||hour||Geometric Coefficient of Variation|Geometric Mean
1391203|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.|The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8.|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Titer||95% Confidence Interval|Geometric Mean
1391204|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix™ Pneumococcal Vaccine Serotypes.|"The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8.~This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups."|At Month 3, aka at one month (1M) post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Titer||95% Confidence Interval|Geometric Mean
1391205|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.|Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to a cut-off value of 0.35μg/mL by enzyme-linked immunosorbent assay (ELISA).|At Month 17, aka one month post the Month 16 booster dose of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1391206|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix™ Pneumococcal Vaccine Serotypes.|Antibody concentrations were measured by enzyme-linked immunosorbent assa y (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to a cut-off value of 0.35μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B™ vaccine co-administered with Synflorix™. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1391207|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations .|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL.|At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B™.|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1391208|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results with study groups pooled by vaccination regimen received.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1391209|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. Results will be posted when they become available.|At Month 51, aka one month post the Month 50 booster dose of Engerix-B™||2017-12-31|12/2017||||
1391210|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1391212|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL.|At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1391213|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1391214|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by RTS,S or Engerix-B™ vaccination regimen received.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1391215|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B™).|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B™|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1391216|NCT01345162|Secondary|Development of Persistent Postoperative Pain|Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain.|Up to 3 months|||||||
1391217|NCT01345162|Secondary|Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications|"Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain.~Assessment of any difference between the two groups."|4 days postherniotomy|||||||
1391218|NCT01345162|Secondary|Difference in Recovering Daily Activity|Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)|4 days after surgical procedure|||||||
1391219|NCT01345162|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded.~Assessment of any difference between the two groups."|4 days postherniotoy|||||||
1391220|NCT01345162|Primary|Analgesic Efficacy|"percentage of patients with NRS≥4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible).~NRS≥4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs."|4 days postherniotomy||||percentage of patients with NRS≥4|||Number
1391221|NCT01345123|Primary|Total Medical Costs That Can be Impacted Per Member Per Month|"total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.~Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded"|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.|||Total dollars / member months||95% Confidence Interval|Mean
1391222|NCT01345123|Secondary|Decision Satisfaction|Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again.|6 months|||||||
1391363|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Day 100|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391223|NCT01345123|Secondary|Decision Conflict|Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents.|||units on a scale||95% Confidence Interval|Mean
1391224|NCT01345123|Secondary|Knowledge|Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score.|||number of correct answers||95% Confidence Interval|Mean
1391225|NCT01345123|Secondary|Quality of Decision Making Process|Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions.|6 months|||||||
1391226|NCT01345123|Secondary|Concordance|Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function|6 months|||||||
1391227|NCT01345123|Secondary|Rate of Targeted Conditions Surgeries|rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.|||percentage of participants|||Number
1391228|NCT01345123|Primary|Total Medical Costs Per Member Per Month|total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Instituted >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.|||Total dollars / member months||95% Confidence Interval|Mean
1391229|NCT01345058|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.|||Participants|||Count of Participants
1391230|NCT01345058|Secondary|Retention Rate|Retention rate is defined as the percentage of participants who remained on the study drug after study completion.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||percentage of participants|||Number
1391231|NCT01345058|Secondary|Time to First Seizure After Therapeutic Dose is Reached|Time in days until the first seizure after the therapeutic dose is reached occurs.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||days||Full Range|Median
1391232|NCT01345058|Secondary|Number of Seizure-Free Days||6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||days||Standard Deviation|Mean
1391233|NCT01345058|Primary|Percentage of Participants Achieving Six Month Seizure Freedom|Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||percentage of participants|||Number
1391234|NCT01345019|Secondary|Percentage of Participants Who Died||From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1391235|NCT01345019|Secondary|Overall Survival|Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was first.|From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||days||95% Confidence Interval|Median
1391236|NCT01345019|Secondary|Time to First and Subsequent On-Study Skeletal Related Event - Number of Events|"A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.~A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The total number of events is reported."|From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||skeletal-related events|||Number
1406617|NCT01206465|Secondary|Pharmacokinetics of PDX- AUClast||Pre-treatment, end of infusion, at 15, 30, and 60 min, and then at 2, 4, 6, 8, 12, 22, 23, 24, 45, and 46 hours for PDX.|AUClast|||ng/ml *hr||Standard Deviation|Mean
1391237|NCT01345019|Secondary|Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient|"A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.~A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The average number of events per patient is reported."|From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||events/patient|||Number
1391238|NCT01345019|Secondary|Time to First On-study Skeletal Related Event - Superiority Analysis|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.|From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||days||95% Confidence Interval|Median
1391239|NCT01345019|Primary|Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.|From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively. The Kaplan-Meier estimate at weeks 25, 49 and 109 is reported.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1391240|NCT01345019|Primary|Percentage of Participants With an On-study Skeletal Related Event|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.|From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1391241|NCT01345019|Primary|Time to First On-study Skeletal Related Event|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.|From randomization until the data cut-off date of 19 July 2016; median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||days||95% Confidence Interval|Median
1391242|NCT01344876|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs.|||participants|||Number
1391243|NCT01344876|Secondary|Treatment Response|"Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin’s lymphoma, acute myeloid leukemia, chronic myeloid leukemia.~“Response” was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment."|From first dose of study medication to withdrawal examination|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.~No statistical analysis provided for treatment response."|||participants|||Number
1391244|NCT01344876|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.|||participants|||Number
1391245|NCT01344824|Secondary|Subjects Experiencing Toxicity|Toxicity will be evaluated using CTCAE criteria, version 3, all grade 3 and 4 events.|90 days|All patients who received treatment were evaluated|||participants|||Number
1391246|NCT01344824|Secondary|Overall Survival|Time of enrollment to date of death.|1400 days||||months||95% Confidence Interval|Median
1391247|NCT01344824|Primary|Progression-free Survival|Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. criteria each year, until subject death|1400 days||||months||95% Confidence Interval|Median
1391248|NCT01344759|Secondary|Room Air SpO2|The patient's oxygen saturation on room air.|During MRI and until recovery room discharge - approximately 30-250 minutes||||percentage of SpO2||Inter-Quartile Range|Mean
1391254|NCT01344629|Secondary|t1/2|terminal half-life of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||hour||Geometric Coefficient of Variation|Geometric Mean
1391255|NCT01344629|Secondary|λz|terminal rate constant of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||/hour||Geometric Coefficient of Variation|Geometric Mean
1391256|NCT01344629|Secondary|Tmax|time from dosing to the maximum concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.|||hour||Full Range|Mean
1391257|NCT01344629|Secondary|AUC0-∞|area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1391258|NCT01344629|Primary|Cmax|maximum measured concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391259|NCT01344629|Primary|AUC0-tz|Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1391260|NCT01344616|Secondary|Gestational Weight||9 months|||||||
1391261|NCT01344616|Primary|Birthweight|Birth weight < 2500 grams|9 months|One Set of twins in the lifestyle counseling arm and 4 sets of twins in the usual clinical care arm|||participants|||Number
1391262|NCT01344538|Primary|Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo.|% Change between baseline and day 28 in PGE2 levels standardized by protein|Baseline and day 28||||percentage of change from baseline||Standard Deviation|Mean
1391263|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
1391264|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
1391265|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
1391266|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images – Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
1391267|NCT01344460|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they had recommended an additional imaging study for each participant, and the data were recorded.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
1391268|NCT01344460|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1=Not confident; 2=Somewhat confident; 3=Confident; 4=Very confident.|Images were taken pre-injection and post-injection|"FAS; In the below table, n signifies the number of segments that were evaluable in specified category."|||Units on scale||Standard Deviation|Mean
1391269|NCT01344460|Secondary|The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
1391270|NCT01344460|Secondary|The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
1391271|NCT01344460|Secondary|The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present.|Images were taken pre-injection and post-injection|FAS|||percentage of accessory|||Number
1391272|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|||Number
1391273|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|||Number
1391274|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifact presence.|||percentage of segments|||Number
1391275|NCT01344460|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||percentage of segments|||Number
1391276|NCT01344460|Secondary|The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis >=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta.|Images were taken pre-injection and post-injection|"Participants in FAS that were evaluable; in below table, n signifies the number of segments that were evaluable in specified category."|||Percentage of location|||Number
1391277|NCT01344460|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR).|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||mm|Participants|Standard Deviation|Mean
1391278|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||millimeter(s) (mm)||Standard Deviation|Mean
1391279|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||millimeter(s) (mm)||Standard Deviation|Mean
1391316|NCT01344057|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using PP set.|||Ratio||95% Confidence Interval|Geometric Mean
1391280|NCT01344460|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease (stenosis) was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of specificity|Participants||Number
1391281|NCT01344460|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%|Clinically significant disease was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of sensitivity|Participants||Number
1391282|NCT01344460|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of specificity|Participants||Number
1391283|NCT01344460|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of sensitivity|Participants||Number
1391284|NCT01344460|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category for both groups."|||Percentage of segments|Participants||Number
1391285|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
1391286|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
1391287|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
1391288|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images – Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
1391289|NCT01344447|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
1391290|NCT01344447|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1 = Not confident, 2 = Somewhat confident, 3 = Confident, and 4 = Very confident.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments that were evaluable for the specified category of each group."|||units on a scale||Standard Deviation|Mean
1391291|NCT01344447|Secondary|Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present. If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments with presence of secondary radiologic indicators for the specified category of each group."|||percentage of segments|||Number
1391292|NCT01344447|Secondary|The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies segments that were evaluable for the specified category of each group."|||percentage of radiologic indicator|||Number
1391293|NCT01344447|Secondary|Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%. If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated. If there was no stenosis of >=70% in a segment then the length was designated as 0.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in the below table, n signifies number of segments that were evaluable for the specified category of each group."|||millimeter(s)||Standard Deviation|Mean
1391294|NCT01344447|Secondary|The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; in the below table, n signifies number of locations that were evaluable for the specified category of each group."|||pecentage of location|||Number
1391295|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|Participants||Number
1391296|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|Participants||Number
1391297|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|Participants||Number
1391298|NCT01344447|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||percentage of segments|Participants||Number
1391299|NCT01344447|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).|Images were taken pre-injection and post-injection|FAS; Number of participants/segments analyzed in below ordered categories (Normal-BRs; Narrowest-BRs; Normal-CIs; Narrowest-CIs) in Enhanced MRA group was 457/6182, 457/6182, 419/1361, 419/1352 respectively; in Unenhanced MRA group was 455/4776, 455/4776, 367/989, 367/980 respectively; in CTA was 442/3158, 442/3158, 419/1569, 419/1555 respectively.|||millimeter(s) (mm)||Standard Deviation|Mean
1391300|NCT01344447|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of specificity|Participants||Number
1391301|NCT01344447|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of sensitivity|Participants||Number
1391302|NCT01344447|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group if it varies from Number of participants/segments analyzed."|||percentage of specificity|Participants||Number
1391303|NCT01344447|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group."|||percentage of sensitivity|Participants||Number
1391304|NCT01344447|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.|Images were taken pre-injection and post-injection|FAS|||percentage of segments|Participants||Number
1391305|NCT01344369|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1391306|NCT01344369|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1391307|NCT01344369|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1391308|NCT01344369|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1391309|NCT01344369|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1391310|NCT01344369|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1391311|NCT01344161|Primary|Change in Insulin Concentrations||3 months minus baseline||||pmol/L||Standard Deviation|Mean
1391312|NCT01344161|Primary|Change in Post Load Glucose Concentrations|It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).|3 months minus baseline||||mmol/L||Standard Deviation|Mean
1391313|NCT01344161|Primary|Change in Glucose Concentrations||3 months minus baseline||||mmol/L||Standard Deviation|Mean
1391314|NCT01344161|Primary|Change in Body Fat Mass|Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.|3 months minus baseline|We assessed body composition by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).|||kg||Standard Deviation|Mean
1391315|NCT01344057|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using PP set.|||Percentage of participants||95% Confidence Interval|Number
1391317|NCT01344057|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 1 up to and including day 4 after the FLUAD vaccination.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; participants who received study vaccination and who provided post-vaccination safety data.|||Number of participants|||Number
1391318|NCT01344057|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had correctly received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1391319|NCT01343901|Secondary|Percentage of Participants With Unresectability Criteria||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
1391320|NCT01343901|Secondary|Total Duration of First Line Bevacizumab Treatment at Day 0||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||months||Full Range|Median
1391321|NCT01343901|Secondary|Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0||Day 0|Efficacy population. Here, number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
1391322|NCT01343901|Secondary|Number of Cumulated Cycles of First Line Bevacizumab at Day 0||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||cycles||Standard Deviation|Mean
1391323|NCT01343901|Secondary|Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery|For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the overall number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.|||Percentage of participants|||Number
1391324|NCT01343901|Secondary|Overall Survival (OS)|OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.|Baseline until death, assessed up to 36 months|Efficacy population|||months||95% Confidence Interval|Median
1391325|NCT01343901|Secondary|Percentage of Participants Who Died||Baseline until death; assessed up to 36 months|Efficacy population|||Percentage of participants|||Number
1391326|NCT01343901|Secondary|Relapse-free Survival (RFS)|RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion [participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.|||Months||95% Confidence Interval|Median
1391327|NCT01343901|Secondary|Percentage of Participants With Disease Relapse|Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion [participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.|||Percentage of participants|||Number
1391328|NCT01343901|Secondary|Progression-free Survival (PFS)|Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population.|||Months||95% Confidence Interval|Median
1391329|NCT01343901|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population|||Percentage of participants|||Number
1391330|NCT01343901|Secondary|Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment|Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.|Baseline up to 36 months|Analysis population consisted of participants with disappeared metastasis left in place with or without surgery. Here number of participants analyzed represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.|||Percentage of participants|||Number
1391331|NCT01343901|Secondary|Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period||Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
1391333|NCT01343901|Secondary|Percentage of Participants With Different Previous Therapies at Day 0|Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX [folinic acid+5-fluorouracil+oxaliplatin], LV5FU2 [leucovorin+5-Fluorouracil], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.|Day 0|Efficacy population. Here number of participants analysed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
1391334|NCT01343901|Secondary|Percentage of Participants With at Least One Disease and Comorbidity at Day 0|Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.|Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.|||Percentage of participants|||Number
1391335|NCT01343901|Primary|Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery|The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
1391336|NCT01343901|Primary|Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery|Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place [missing metastases]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
1391337|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391338|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391339|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391340|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391341|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391342|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391343|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391344|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1391345|NCT01343888|Secondary|Early Treatment Success (ETS)|Early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants|||Number
1391346|NCT01343888|Secondary|Sustained Virological Response 24 Weeks Post-treatment (SVR24)|Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1391347|NCT01343888|Primary|Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1391348|NCT01343823|Secondary|Time to Symptom Resolution Based on the Visual Analog Scale (VAS)|"Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups.~The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from totally resolved to very severe."|6 hours|Time to Symptom Resolution Based on the VAS (Safety Population)|||hours||95% Confidence Interval|Median
1391349|NCT01343823|Primary|Safety and Efficacy of Ecallantide|"Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy.~Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER.~A responder was defined as a patient meeting all six discharge eligibility criteria as below:~Improvement of edema to “a little better” or “a lot better” as assessed by health care provider using a five point scale~Stable vital signs (within an acceptable range)~Absence of stridor~Absence of dyspnea or use of accessory muscles during respiration~Absence of drooling~Able to drink without difficulty"|6 hours|Safety Population|||participants||95% Confidence Interval|Number
1391350|NCT01343667|Primary|Major Adverse Events (MAE)|Major Adverse Events include death, stroke and myocardial infarction|Onset from start of index procedure to 30-day follow-up assessment|Enrolled subjects with successful procedure and sufficient follow-up|||participants|||Number
1391351|NCT01343485|Primary|On-time Completion of the Human Papillomavirus Vaccine Series||32 weeks after receipt of initial vaccine||||participants|||Number
1391352|NCT01343368|Secondary|Comparison of Antimullerian Hormone (AMH) Levels After Transplant|Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.|Day 180 after Transplant|Four patients on the Observational and 10 patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.|||ng/ml||Standard Deviation|Mean
1391353|NCT01343368|Secondary|Comparison of Antimullerian Hormone (AMH) Levels After Transplant|Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.|Day Prior to Transplant|Six patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.|||ng/ml||Standard Deviation|Mean
1391354|NCT01343368|Secondary|Comparison of Leuprolide Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|2 years|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391355|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|1 year|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391356|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Day 180|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391357|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Day 100|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391358|NCT01343368|Secondary|Comparison of Lutineizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Baseline|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis.|||IU/L||Standard Deviation|Mean
1391359|NCT01343368|Secondary|Comparison of Number of Patients Who Resumed Menstrual Cycles|Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant|Day 365 Post Transplant|Only 6 of the 10 patients that started on the Observational Arm were evaluable. The 2 patients were lost to follow-up.|||Participants|||Count of Participants
1391360|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|2 years|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391361|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|1 year|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391362|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Day 180|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
1391364|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Baseline|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis.|||IU/L||Standard Deviation|Mean
1391365|NCT01343368|Secondary|Comparison of Number of Patients Who Stopped Menstrual Bleeding|Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant|From Baseline Through Day 365|Five patients on the Interventional arm and 10 patients on the Observational arm were lost to follow-up by Day 365.|||Participants|||Count of Participants
1391366|NCT01343368|Primary|Comparison of Number of Patients With Ovarian Failure|Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH >40 IU/L) after transplant.|Through Day 180 Post Transplant||||Participants|||Count of Participants
1391367|NCT01343277|Primary|Overall Survival (OS)|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]|Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).|||Months||95% Confidence Interval|Median
1391368|NCT01343277|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])|Safety population included all the treated participants.|||Participants|||Number
1391369|NCT01343277|Secondary|Duration of Response|"Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.~Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Months||95% Confidence Interval|Median
1391370|NCT01343277|Secondary|Objective Response Rate|The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Percentage of Participants||95% Confidence Interval|Number
1391371|NCT01343277|Secondary|Time to Progression|"Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.~Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Months||95% Confidence Interval|Median
1391372|NCT01343277|Secondary|Progression-Free Survival (PFS)|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Months||95% Confidence Interval|Median
1391373|NCT01343251|Secondary|Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)|Compare incidence of hospitalization (for any reason) between study arms. Reasons for hospitalizations included: infection, cardiac problems, bleeding, vascular access thrombosis, fall (injury), hematuria, fluid overload, peripheral neuropathy, pulmonary embolism, edema, and shortness of breath.|1 year||||Percentage of patients|||Number
1391374|NCT01343251|Secondary|Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)|Compare vascular intervention rates between study arms. The vascular interventions which were included were: Angioplasty, Thrombectomy, Arteriovenous (AV) Fistulogram/Diagnostic Angiogram, Banding, Access Removal, Access Exchange, Access Revision, Creation of New Access, and any combination of these interventions which were performed simultaneously.|1 year||||percentage of participants|||Number
1391396|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18||Baseline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.|||percent change||Standard Deviation|Mean
1391375|NCT01343251|Secondary|Quality of Life|Compare the RAND Short Form (SF)-36 Health Survey, Total Test Scores at baseline, 3, 6, and 12 months between study arms. Total test scores range on a scale from 0-100, with the lower the score equating to more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The total score is calculated using a methodology described by the RAND Corporation, which assigns a recoded value to each survey item. Recoded items are averaged amongst scales and the total score is an average of the eight sections. (http://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_core_36item_scoring.pdf).|1 year|The number of completed tests varied by time point and study group. The number of completed tests for Test 1, Test 2, Test 3, and Test 4 was 14, 13, 10, and 8 for the HeRO Graft group and 17, 13, 7, and 4 for the Control group, respectively. Only completed tests were included in the analysis.|||units on a scale||Standard Deviation|Mean
1391376|NCT01343251|Secondary|Infection Rate (Percentage of Participants With at Least One Infection)|Compare incidence of infection between study arms|1 year||||Percentage of Patients|||Number
1391377|NCT01343251|Primary|Mortality|Compare mortality rate between study arms|1 year||||percentage of participants who died|||Number
1391378|NCT01343095|Secondary|Amount of Sedative Use (Propofol and Demedetomidine )|Mean of sedative daily use (Propofol and Demedetomidine )|During the Study Period (Study Days 0-7)||||mcg/kg||Full Range|Mean
1391379|NCT01343095|Secondary|Amount of Analgesic Use|Mean of analgesic daily use|During the Study Period (Study Days 0-7)||||mg||Full Range|Mean
1391380|NCT01343095|Secondary|Amount of Sedative Use (Midazolam and Lorazepam)||During the Study Period (Study Days 0-7)||||mg||Full Range|Mean
1391381|NCT01343095|Secondary|Sleep Efficiency and Architecture|Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.|Overnight (10pm-6am) on study day 2 or 3|Sleep measurement equipment was not available for use during the study period||||||
1391382|NCT01343095|Secondary|Noise Attenuation|The reduction in noise experienced by the subject when using the study intervention.|Overnight (10pm-6am) on study day 2 or 3.|Devices were unable to measure noise above 85 dB(A) from the in-ear location; no noise data was collected.||||||
1391383|NCT01343095|Primary|Days Free of Delirium or Coma||During the Study Period (Study Days 0-7 while patients were in ICU)||||days||Full Range|Mean
1391384|NCT01343082|Primary|Change From Baseline in IOP (Intraocular Pressure) at End of Study||Treatment period: Week 0 (Baseline) and Week 52 (End of Study)||||mmHg||Standard Deviation|Mean
1391385|NCT01343056|Secondary|Systolic Blood Pressure|Systolic blood pressure is the pressure when the heart beats while pumping blood.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mmHg||Full Range|Median
1391386|NCT01343056|Secondary|Diastolic Blood Pressure|Diastolic blood pressure is the pressure when the heart is at rest between beats.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mmHg||Full Range|Median
1391387|NCT01343056|Secondary|Body Mass Index|Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||kg/m^2||Full Range|Median
1391388|NCT01343056|Secondary|Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores|"The DES-SF is a validated, 8 item scale that measures the self-efficacy of patients with diabetes. Responses are selected from a 5-point Likert scale (Strongly Disagree (1), Somewhat Disagree (2), Neutral (3), Somewhat Agree (4), Strongly Agree (5)). The scale is scored by averaging the scores of all completed items (sum of scores divided by 8).~A positive number represents an improvement in overall patient self-efficacy (empowerment) from the baseline score and 6 month follow up time point."|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||units on a scale||Standard Deviation|Mean
1391389|NCT01343056|Secondary|Low Density Lipoprotein (LDL, mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mg/dL||Full Range|Median
1391390|NCT01343056|Secondary|High Density Lipoprotein (HDL, mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mg/dL||Full Range|Median
1391391|NCT01343056|Secondary|Total Cholesterol (mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mg/dL||Full Range|Median
1391392|NCT01343056|Primary|Hemoglobin A1C (HbA1C, %)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||percentage of glycosolated hemoglobin||Full Range|Median
1391393|NCT01343004|Secondary|Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months||18 months|Safety population included all patients who received 1 or more doses of study medication|||Hypercalcemic events|||Number
1391394|NCT01343004|Secondary|Number of Participants With Non-vertebral Fractures at 18 Months||18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.|||Participants|||Number
1391395|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18||Baseline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.|||percent change||Standard Deviation|Mean
1391397|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months||Basline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.|||percent change from baseline||Standard Deviation|Mean
1391398|NCT01343004|Primary|Number of Participants With New Vertebral Fractures at 18 Months||18 months|Modified intent-to-treat (MITT) population included all patients with pre-treatment and end-of-treatment evaluable radiologic assessment (spine X-ray).|||participants|||Number
1391399|NCT01342965|Secondary|Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire||approximately 21 months|||||||
1391400|NCT01342965|Secondary|Safety: Incidence of Adverse Events||36 months|||||||
1391401|NCT01342965|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|Baseline to the end of the study (3 years, 1 month)|Full analysis set: All randomized participants.|||Months||95% Confidence Interval|Median
1391402|NCT01342965|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants. Only participants who had a complete response or partial response were included in the analysis.|||Months||95% Confidence Interval|Median
1391403|NCT01342965|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.|||Percentage of participants|||Number
1391404|NCT01342965|Secondary|Percentage of Responders as Assessed by the Investigator|A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.|||Percentage of responders|||Number
1391405|NCT01342965|Primary|Investigator-assessed Duration of Progression-free Survival|The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.|Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)|Full analysis set: All randomized participants.|||Months||95% Confidence Interval|Median
1391406|NCT01342926|Secondary|The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22)|Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18|PD Concentration Population: all participants in the ITT Population with at least one PD sample|||picogram (PG)/ML||Standard Deviation|Mean
1391407|NCT01342926|Secondary|Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||mL||95% Confidence Interval|Geometric Mean
1391408|NCT01342926|Secondary|Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||Days||95% Confidence Interval|Geometric Mean
1391409|NCT01342926|Secondary|Clearance (CL) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||mL/h||95% Confidence Interval|Geometric Mean
1391410|NCT01342926|Secondary|Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||nanogram (ng)/mL||95% Confidence Interval|Geometric Mean
1391411|NCT01342926|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants|Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|Pharmacokinetic (PK) Parameter Population: all participants in the ITT Population with derived PK parameters|||microgram (mcg)*hours (h)/mL||95% Confidence Interval|Geometric Mean
1391412|NCT01342926|Secondary|Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18|Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and every month up to Month 18|ITT Population|||Scores on a scale||Standard Deviation|Mean
1391413|NCT01342926|Secondary|Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye|Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing >30, >=15, >=10, >=5 and <5 letters.|Month 12 and Month 18|ITT Population|||Participants|||Number
1391414|NCT01342926|Secondary|Change From Baseline in Area of Total hypoAF in Study Eye|Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, 6 months, 12 months and 18 months|Efficacy Population|||mm^2||90% Confidence Interval|Mean
1391415|NCT01342926|Secondary|Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye|Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, 6 months, 12 months and 18 months|Efficacy Population|||mm^2||90% Confidence Interval|Mean
1391416|NCT01342926|Primary|Number of Participants With Abnormal Magnetic Resonance Imaging (MRI)|Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported.|Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal|ITT Population|||Participants|||Number
1391417|NCT01342926|Primary|Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI)|The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed.|At any point from Baseline through follow-up visit.|ITT Population|||Participants|||Number
1391418|NCT01342926|Primary|Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI)|12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit|ITT Population|||Participants|||Number
1391430|NCT01342887|Primary|Maximum Tolerated Doses Mitoxantrone Hydrochloride and Etoposide When Combined With Cyclosporine and Pravastatin Sodium|"Determine the doses of mitoxantrone and etoposide that, when combined with CSA and pravastatin, meet minimum standards for both efficacy and toxicity and have the highest efficacy rate among several mitoxantrone and etoposide doses.~Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0."|After completion of first 2 courses, up to 22 weeks||||doses tolerated|||Number
1391432|NCT01342770|Secondary|Pre-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Baseline|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained|||SUV||Full Range|Median
1391419|NCT01342926|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR)|Vital signs included HR of CCR at the indicated time points: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:< 40 beats per minute (bpm) and high: >100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.|Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit|ITT Population|||Participants|||Number
1391420|NCT01342926|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: Baseline, month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: <85 millimeter of mercury (mmHg) and high: >160 mmHg and DBP was defined as: low:<45 mmHg and high: >100 mmHg. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.|Up to 21 months|ITT Population|||Participants|||Number
1391421|NCT01342926|Primary|Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period||Up to 21 months|ITT Population|||Participants|||Number
1391422|NCT01342926|Primary|Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs.|Up to 21 months|ITT Population: all participants that completed the observation period and Baseline visit, and were subsequently randomized to treatment and were administered at least one IV dose.|||Participants|||Number
1391423|NCT01342926|Primary|Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye|Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit.|Baseline (BL), 6 months, 12 months and 18 months|Efficacy Population. Participants who developed CNV in the study eye during the treatment period are excluded from Efficacy Population per protocol.|||square millimeter (m^2)||90% Confidence Interval|Mean
1391424|NCT01342913|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.|Baseline and Day 85|Only participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1391425|NCT01342913|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
1391426|NCT01342913|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1391427|NCT01342887|Secondary|Frequency and Severity of Regimen-associated Toxicities|Estimate the frequency and severity of regimen-associated toxicities, along with 28-day mortality after start of study treatment|At 28 days||||Participants|||Count of Participants
1391428|NCT01342887|Secondary|Disease-free Survival of Patients That Achieve CR/CRi|Describe the disease-free survival of patients that achieve CR/CRi.|Up to 4.5 years||||Participants|||Count of Participants
1391429|NCT01342887|Secondary|CR/CRi|"Describe the disease-free survival of patients that achieve Complete Remission (CR)/CR with inadequate recovery of peripheral blood cell counts (CRi).~Categorized according to criteria recommended by an International Working Group."|After completion of first 2 courses, up to 22 weeks||||Participants|||Count of Participants
1391433|NCT01342770|Secondary|Percent Change in SUVmax From the PET Scan|The percent change from pre to post-intervention in SUV max values will be summarized using descriptive statistics and simple graphical plots.|Baseline to the time of surgery, after 42 days of treatment|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained|||Percent change in tumor SUV max values||Full Range|Median
1391434|NCT01342770|Secondary|Percent Change in PPARy|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in PPARy measurements||Full Range|Median
1391435|NCT01342770|Secondary|Percent Change in p21|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in p21 measurements||Full Range|Median
1391436|NCT01342770|Secondary|Percent Change in MUC1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in MUC1 measurements||Full Range|Median
1391437|NCT01342770|Secondary|Percent Change in Cyclin D1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in Cyclin D1 measurements||Full Range|Median
1391438|NCT01342770|Secondary|Number of Participants With Complete Pathologic Response|Complete pathologic response was defined as no viable residual tumor cells. Acellular residual mucin pools also considered a pathologic complete response.|Up to the time of surgery, after 42 days of treatment|Includes all registered participants|||participants|||Number
1391439|NCT01342770|Secondary|Number of Participants With Clinical Response, Based on Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1|Clinical response rates will be summarized. Complete response (CR) is the disappearance of all non-nodal target lesions (TL) and each target lymph node (LN) must have reduction in short axis to <1.0cm. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the non-nodal TR and the short axis of the target LN with the baseline sum diameters (BSD) as reference. Progression (PD) is at least 1 new malignant lesion or LN whose short axis increased to >1.5 cm or at least a 20% increase in the sum of TL diameters with the minimum sum of diameters as reference.|Up to the time of surgery, after 42 days of treatment|Data not collected due to a study team decision not to analyze this endpoint.||||||
1391440|NCT01342770|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.0|To evaluate the adverse events profile, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (both regardless of attribution as well as those that are at least possibly, probably, or definitely related) will be tabulated and summarized.|Up to the time of surgery, after 42 days of treatment|Includes all registered eligible participants|||participants|||Number
1391441|NCT01342770|Secondary|Gene Expression Analysis of RNA From Bronchial Brush Cells|For the gene expression profiles obtained from the data from normal bronchial brush cells, each participant’s pre- and post gene expression will be graphically represented and the mean expression levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Up to the time of surgery, after 42 days of treatment|Data not collected due to a study team decision not to analyze this endpoint.||||||
1391442|NCT01342770|Secondary|Change in Levels of Serum CRP|Each participant’s pre- and post serum levels of CRP will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline and at the time of surgery, after 42 days of treatment|Data not collected due to a study team decision not to analyze this endpoint.||||||
1391443|NCT01342770|Secondary|Change in Levels of Serum CA-153|Each participant’s pre- and post serum levels of CA-153 will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline and at the time of surgery, after 42 days of treatment|Data were not collected due to a study team decision not to analyze this endpoint.||||||
1391444|NCT01342770|Secondary|Change in Apoptosis Assessment (e.g., Caspase-3)|Changes in the expression levels (or grades) from baseline (prior to intervention) to post-intervention (resected tumor sample) will be plotted graphically as well as formally assessed using the McNemar’s tests (for categorical variables) or Wilcoxon signed rank tests (for continuous variables) respectively.|Baseline and at the time of surgery, after 42 days of treatment|Data were not collected. Study team decision not to analyze this endpoint.||||||
1391445|NCT01342770|Primary|Percent Change in Ki-67 by Immunohistochemistry (IHC)|Changes in the expression levels of Ki-67 will be plotted graphically, and percent change in expression levels will be formally assessed using the paired t-test or the Wilcoxon signed rank test, if the assumptions of the t-test (i.e. normality) are not met.|Baseline and at the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in Ki-67 measurements||Full Range|Median
1391446|NCT01342757|Secondary|Mean Change in Metabolite Levels|Baseline MRS was performed 1–3 days before initiation of treatment. Follow-up MRS studies were performed at day 7. A standard quadrature head coil was used to collect MR data. The change of metabolite level in choline (Cho) and N-acetyl aspartate (NAA) were calculated in ratio by (metabolite after treatment / metabolite before treatment − 1). The reported ratios represent the Cho-to-NAA ratio at day 7 compared with day 0.|Baseline to 1 week||||Cho/NAA Ratios||Full Range|Mean
1391447|NCT01342757|Primary|Measurable Change on Magnetic Resonance Spectroscopy Imaging After Vorinostat Administration|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and N-acetyl aspartate (NAA) signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks|Patients collected until measurable spectroscopic indexes were available in at least three cases with metabolic response and three without metabolic response|||Spectroscopic index||Standard Deviation|Mean
1391448|NCT01342757|Primary|Proportion of Patients Who Experience Metabolic Restoration Between the Responders and Non-responder Groups by MRS Scans|Baseline MRS was performed 1–3 days before initiation of treatment. Follow-up MRS studies were performed at day 7. A standard quadrature head coil was used to collect MR data. A responder was defined as stable disease: determined in glioblastoma to be between a 25% volume increase and 50% volume decrease compared to baseline imaging at the therapy initiation at the 2 month follow-up visit. The spectroscopic restoration index was calculated (ΔN-acetyl aspartate + Δcreatine + Δmyo-inositol − Δcholine − Δ(lactate / lipids)).|After 1 week|In five of the twelve cases spectroscopic indices could not be calculated because the tumor volume was outside of reliably measured voxels. These were primarily accounted for by tumor closeness to the skull or the small size of residual tumor.|||Participants|||Count of Participants
1391449|NCT01342757|Primary|Proportion of Patients With Magnetic Resonance Spectroscopy (MRS) Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and N-acetylaspartate signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks||||participants|||Number
1391450|NCT01342666|Primary|High Density Lipoprotein Cholesterol (HDL-c)|To evaluate the effect of two daily tomatoes consumption on HDL-c levels.|Baseline and after one month|The sample size was calculated using the formula for means for two-tailed comparisons. According to a previous report, we expected a minimal change of 5 mg/dL in HDL-c after one month of consumption. Using a SD of 9 mg/dL with alfa of 0.05 and study power of 80%, a total of 48 subjects were calculated.|||mg/dL||Standard Deviation|Mean
1391451|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 28|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 28|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome|||gm/dL||Standard Deviation|Mean
1391452|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 24|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 24|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.|||gm/dL||Standard Deviation|Mean
1391453|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 20|Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 20|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point.|||Grams per deciliter (gm/dL)||Standard Deviation|Mean
1391454|NCT01342549|Primary|Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.||24 weeks||||Weeks||Standard Deviation|Mean
1391455|NCT01342523|Secondary|Increased Quit Attempts|Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.|Measured at the 1 month, 3 month and 7 month follow up assessments.|||||||
1391456|NCT01342523|Secondary|Treatment Satisfaction|We will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.|Measured at the 1 month, 3 month and 7 month follow up assessments|||||||
1391457|NCT01342523|Secondary|Perceived Support|We will measure perceived support from both treatment and non-treatment resources.|Measured at the1 month, 3 month and 7 month follow up assessments.|||||||
1391458|NCT01342523|Secondary|Withdrawal Symptoms|We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.|||||||
1391459|NCT01342523|Secondary|Effectiveness of the Experimental Resources.|We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.|Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.|||||||
1391460|NCT01342523|Secondary|Resource Use/Engagement|We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.|Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.|||||||
1391461|NCT01342523|Secondary|Smoking Outcomes|Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.|||||||
1391462|NCT01342523|Primary|7-Day Point-Prevalence Abstinence From Smoking|Abstinence will be defined as 7-day point prevalence.|Measured after the 3 month follow up assessment|"Intention to treat (ITT)"|||percentage of participants not smoking|||Number
1391463|NCT01342510|Primary|Number of Patients With Pain Associated With Injection of Propofol.|Ten seconds following injection of propofol, subjects were asked “Are you having pain at your IV site?” Any behavioral signs were noted. Injection pain was assessed using the following four point scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).|< 1 minute.||||participants|||Number
1391464|NCT01342510|Primary|Pain With Injection of Propofol|Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).|Approximately one minute following administration of propofol.|||||||
1391465|NCT01342484|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment|Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.|||mmol/L||Standard Error|Least Squares Mean
1391466|NCT01342484|Secondary|Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State|DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100.|Baseline and 4 weeks or 8 weeks or 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. OR (Original Results). The analysis excludes placebo patients and 1 FAS patient from Linagliptin 1 mg group.|||Percentage of DPP-4 inhibition||Inter-Quartile Range|Median
1391467|NCT01342484|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.|||Percentage of HbA1c||Standard Error|Least Squares Mean
1391468|NCT01342471|Secondary|TV Viewing Time|Change in self-reported TV viewing time per day between 0 and 6 months|0 and 6 months||||hr/day||Standard Deviation|Mean
1391469|NCT01342471|Secondary|Weight|Change in weight in kgs between 0 and 6 months|0 and 6 months||||kg||Standard Deviation|Mean
1391470|NCT01342471|Secondary|TV Related Energy Intake|Change in energy intake (kcals/day) while watching TV between 0 and 6 months|0 and 6 months||||kcals/day||Standard Deviation|Mean
1391471|NCT01342471|Secondary|Total Energy Intake|Change in total energy intake(kcals/day) between 0 and 6 months|0 and 6 months||||kcals/day||Standard Deviation|Mean
1391472|NCT01342471|Primary|Physical Activity (Steps/Day)|Change in pedometer measured steps per day between 0 and 6 months|0 and 6 months||||steps/day||Standard Deviation|Mean
1391473|NCT01342458|Secondary|Paracetamol Intake|Paracetamol intake (500 mg), number of tablets per month.|6 month||||tablets per month||Inter-Quartile Range|Median
1391474|NCT01342458|Secondary|First Peak of the Knee Adduction Moment (KAM) During Gait.|The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure.|6 month||||% body weight x height in centimeters||Standard Deviation|Mean
1391475|NCT01342458|Secondary|Six-minute Walk Test|The six-minute walk test assesses distance in meters walked over 6 minutes.|6 month||||meter||Standard Deviation|Mean
1391476|NCT01342458|Secondary|Global Score of the Lequesne´s Questionaire Algo-functional.|This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively.|6 month||||score||Standard Deviation|Mean
1391477|NCT01342458|Secondary|WOMAC Total Score|The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition.|6 month||||score||Standard Deviation|Mean
1391478|NCT01342458|Secondary|WOMAC Physical Function Subscale|The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.|6 month||||score||Standard Deviation|Mean
1391479|NCT01342458|Secondary|WOMAC Stiffness Subscale|The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.|6 month||||score||Standard Deviation|Mean
1391480|NCT01342458|Primary|Western Ontario and McMaster Universities (WOMAC) Pain Subscale|The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.|6 month|An intention-to-treat analysis was performed, and the missing data were treated as missing completely at random (MCAR) using the Mahalanobis imputation method (SOLAS software version 4.0; Statistical Solutions Ltd., Cork, Ireland).|||score||Standard Deviation|Mean
1391481|NCT01342445|Primary|Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)|BRIEF-A is a standardized self-report measure that captures adults’ views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.|after receiving Placebo or LDX for 1 week||||T score||Standard Deviation|Mean
1391482|NCT01342445|Primary|Conners Adult ADHD Rating Scale - Short Version (CAARS)|CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).|after receiving Placebo or LDX for 1 week||||T score||Standard Deviation|Mean
1391483|NCT01342341|Primary|Alcohol Consumption in Drinks/Week.|Each subject will record how many drinks/week they are consuming while on the study drug and placebo during the 45-day study. The primary outcome of this study is to determine the effect of chlorzoxazone on alcohol consumption. Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide.|45 days||||number of drinks||Standard Deviation|Mean
1391484|NCT01342211|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 71, 85, 99, 127, 141|Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for percent change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.|||percent change||Standard Deviation|Mean
1391485|NCT01342211|Other Pre-specified|Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 71, 85, 99, 127, 141|Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.|||mg/dL||Standard Deviation|Mean
1391486|NCT01342211|Secondary|Number of Participants With Anti-drug Antibody (ADA)|Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.|Day 1 up to Day 141|Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).|||participants|||Number
1391487|NCT01342211|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters|Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of >200 millisecond (msec) and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval; maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF).|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1391488|NCT01342211|Secondary|Number of Participants With Clinically Relevant Laboratory Abnormalities|Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN).|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug. Here 'N' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1391489|NCT01342211|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.|||adverse events|||Number
1391490|NCT01342211|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1391491|NCT01342211|Secondary|Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.|||percent change||Standard Deviation|Mean
1391492|NCT01342211|Secondary|Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for change at Day 85 in lipid parameters ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1391493|NCT01342211|Secondary|Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)||Day 29, 57, 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
1391494|NCT01342211|Secondary|Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)||Day 29, 57, 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
1391495|NCT01342211|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Here 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
1391496|NCT01342172|Secondary|To Determine the Impact of Treatment on Circulating Tumor Cells|Circulating epithelial tumor cells (CTC) will be investigated as an experimental endpoint using immunofluorescence techniques and CTC identification by positive expression of epithelial markers and a viability marker and negative expression of hematopoietic markers. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycles 0, 1 and 2 (each Cycle is 21 days)|||||||
1391497|NCT01342172|Secondary|To Determine the Impact of Treatment on Peripheral Blood Immune Cell Subsets|We plan to determine the changes in cellular immunity with lenalidomide in peripheral blood mononuclear cells including Tregs, NK, NKT cells (Berg et al JCO 2010), sIl-2R, TNF alpha (Bartlett et al BJC 2004) and markers indicative of activation, i.e. CD107a. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycle 0 and Day 1 of Cycle 2 (each Cycle is 21 days)|||||||
1391498|NCT01342172|Secondary|To Evaluate Lenalidomide as Maintenance Treatment in Patients Achieving an Objective Response or Stable Disease Following Completion of 6 Cycles of Combination Therapy.||168 days|||||||
1391499|NCT01342172|Secondary|To Determine the Safety of Combination Therapy With Gemcitabine, Cisplatin, and Lenalidomide|The safety of combination therapy with gemcitabine, cisplatin plus lenalidomide as determined by the frequency and severity of adverse events as per the NCI Common Terminology for Adverse Events (CTCAE) version 4.0.|Day 1 and Day 8 of each treatment cycle; 21 days after the last dose of Lenalidomide|||||||
1391500|NCT01342172|Secondary|To Determine the Objective Response Rate to Treatment With Gemcitabine, Cisplatin, Plus Lenalidomide|The objective response rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST). Restaging CT scans will be performed after every 2 cycles (after cycles 2, 4, and 6). Each cycle is 21 days.|After every 2 cycles (a cycle is 21 days)|||||||
1391501|NCT01342172|Primary|Phase II: Progression-free Survival at 1 Year||1 year|||||||
1391581|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1391502|NCT01342172|Primary|Phase I: To Determine the Recommended Phase II Dose of the Combination of Gemcitabine, Cisplatin, Plus Lenalidomide|Safety as measured by the frequency and type of adverse event as per the NCI Common Terminology for Adverse Events (CTCAE) version 4 on Day 1 of each cycle (Cycle is 21 days).|Day 1 of each 21 day cycle|The dose of lenalidomide was not escalated beyond 10 mg because of cytopenias requiring repeated dose delays and reductions.||||||
1391503|NCT01342107|Primary|Lens Wettability|As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.|16 hours|Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set.|||percentage of lenses||95% Confidence Interval|Number
1391504|NCT01342094|Primary|Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study|Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)||||mmHg||Standard Deviation|Mean
1391505|NCT01342081|Primary|Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study|Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)||||mmHg||Standard Deviation|Mean
1391506|NCT01342029|Secondary|Cardiac Magnetic Resonance (CMRs)|"Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 2nd week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion reserve index.~Myocardial perfusion reserve index (MPRI) was assessed using the first-pass perfusion intensity curves during stress and rest cardiac magnetic resonance imaging. First-pass perfusion images were analysed using CAAS MRV CMRI analysis software Version 3.3 (Pie Medical Imaging B.V., Maastricht, the Netherlands). Global MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.~Higher MPRI represents better myocardial perfusion reserve. Since MPRI is an index, there is no unit."|2 weeks (first intervention) and 6 weeks (second intervention)|Out of 142 randomized, there were 10 dropouts and 4 missing treatment periods. Therefore 128 was included in analysis|||myocardial perfusion reserve index||Standard Deviation|Mean
1391507|NCT01342029|Primary|Seattle Angina Questionnaire (SAQ)|"Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period.~The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important."|2 weeks (first intervention) and 6 weeks (second intervention)|Not all participants answered every question in the SAQ, thus the numbers are different for each question.|||Units on scale||Standard Deviation|Mean
1391508|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 8, 16 hours|Intent to treat.|||Degrees||Standard Deviation|Mean
1391509|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 1, 8 hours|Intent to Treat.|||Degrees||Standard Deviation|Mean
1391510|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)|Day 90||||Subjective Rating||Standard Deviation|Mean
1391511|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert item|Day 90|||||||
1391512|NCT01341912|Secondary|To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis|"The efficacy of human-cl rhFVIII will be determined using a 4 point efficacy assessment scale.~After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 - 12 hours after an infusion requiring up to 2 infusions for complete resolution.~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.~The assessment was made at the end of a BE in case more than one infusion was needed."|up to 3 years||||percentage of bleeding episodes|Participants||Number
1391513|NCT01341912|Primary|Long-term Immunogenicity|Patients will be monitored for inhibitors against FVIII every 3 months. Blood samples were drawn and inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) in the central lab.|up to 3 years||||occurrence of inhibitors|||Number
1391514|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL|iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set|||visits||Standard Deviation|Mean
1391515|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set|||visits||Standard Deviation|Mean
1391516|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1391517|NCT01341782|Secondary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|The last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1391518|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia|The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).|The Full Analysis Set (FAS) consists of all randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline iPTH measurement.|||percentage of participants||95% Confidence Interval|Number
1391519|NCT01341782|Primary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).|The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken.|||percentage of participants||95% Confidence Interval|Number
1391520|NCT01341600|Primary|Change in Platelet Aggregation Following Therapy With Clopidogrel|ADP mediated platelet aggregation measured 4 hours post Day 8 clopidogrel dose|4 hours post Day 8 dose||||percentage of aggregation||Standard Deviation|Mean
1391521|NCT01341600|Secondary|Level of Active Clopidogrel Metabolite|The level of the active clopidogrel metabolite will be measured at at 0.25, 0.5, 1, 2, and 4 hours after the Day One dose is administered for pharmacokinetic analysis. The analysis will measure the Area Under the Curve.|Baseline, 0.25, 0.5, 1, 2, and 4 hours||||ng h/mL||Standard Deviation|Mean
1391522|NCT01341600|Secondary|Change in Platelet Aggregation Following Therapy With Clopidogrel and Omeprazole|The change in maximum platelet aggregation in response to ADP 4-hours post dose on day 8 of therapy with clopidogrel and omeprazole will be compared to the baseline measure of platelet aggregation at day 1 prior to drug therapy|Baseline, Day 8||||percentage of aggregation||Standard Deviation|Mean
1391523|NCT01341600|Primary|Change in Platelet Aggregation Following Therapy With Clopidogrel|Adenosine diphosphate (ADP) mediated platelet aggregation measured 4 hours post-dose of clopidogrel on Day 1.|Day 1, 4 hours post clopidogrel dose||||percentage of aggregation||Standard Deviation|Mean
1391524|NCT01341587|Primary|Change in HbA1c|Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months|6 months|Results for change were not collected because the study was stopped. Participants were lost to follow-up and stopped using the meters||||||
1391525|NCT01341444|Primary|Number of Participants With Surgical Site Complications (SSCs)|The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing.|62 Days|Analysis of this endpoint was based on the Full analysis Set (FAS population). The FAS population consists of participants who met all of the pre- and intra-operative eligibility criteria, were randomized and received treatment. Subjects without SSC must have received 5 days of Prevena or at least 3 days of SOC dressing and completed 30 day visit.|||Participants|||Count of Participants
1391526|NCT01341301|Secondary|Incidence and Severity of GVHD, Graded According to Standard Criteria|Reported descriptively|Assessed up to 1 year|Data were not collected||||||
1391527|NCT01341301|Secondary|Regimen Related Toxicities Graded According to the National Cancer Institute (NCI) Common Toxicity Criteria, Version 3.0|Reported descriptively|Assessed up to 1 year|Data were not collected||||||
1391528|NCT01341301|Secondary|Pace of T-cell and B-cell Immune Recovery|Reported descriptively|Assessed up to 1 year|Data were not collected||||||
1391529|NCT01341301|Primary|Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT)|To assess relapse free survival in participants undergoing Hematopoietic Stem Cell Transplant (HSCT) using the Thomas Jefferson University 2 step approach with an extra day inserted between the donor lymphocyte infusion (DLI) and administration of cyclophosphamide.|1 year after undergoing hematopoietic stem cell transplant||||Participants|||Count of Participants
1391530|NCT01341067|Secondary|Change in Basal Insulin Dose From Baseline Values||Assessed at baseline and 6 months||||units of insulin||Standard Deviation|Mean
1391531|NCT01341067|Secondary|Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl||Measured at baseline and 6 months||||percentage of time spent >180 mg/dl||Standard Deviation|Mean
1391532|NCT01341067|Secondary|Percentage of Time Spent at Glycemic Levels <65 mg/dl||Measured at baseline and at 6 months||||percentage of time spent < 65 mg/dl||Standard Deviation|Mean
1391533|NCT01341067|Primary|Change in HgbA1c||Measured at 6 months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1391534|NCT01340937|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population defined as all vaccinated participants with safety follow up and temperature data. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.|||Percentage of participants|||Number
1391535|NCT01340937|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.|||Percentage of participants|||Number
1391536|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes|Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||µg/mL||95% Confidence Interval|Geometric Mean
1391537|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391538|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391539|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391540|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391541|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391542|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391582|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment|Baseline to Week 48 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1391543|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391544|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391545|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391546|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391547|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391548|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391549|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391550|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391551|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391552|NCT01340937|Secondary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391553|NCT01340937|Secondary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391583|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1391554|NCT01340937|Secondary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391555|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Titer||95% Confidence Interval|Geometric Mean
1391556|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Titer||95% Confidence Interval|Geometric Mean
1391557|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Titer||95% Confidence Interval|Geometric Mean
1391558|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391559|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391560|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391561|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391562|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Tetanus Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||IU/mL||95% Confidence Interval|Geometric Mean
1391563|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||IU/mL||95% Confidence Interval|Geometric Mean
1391564|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||mIU/mL||95% Confidence Interval|Geometric Mean
1391565|NCT01340937|Secondary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391584|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment|Baseline to Week 24 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1391566|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||µg/mL||95% Confidence Interval|Geometric Mean
1391567|NCT01340872|Other Pre-specified|Change From Baseline in Simple Clinical Colitis Activity Index (SCCAI) Score at Week 64 (Full Analysis Set)|"Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (in participants with UC only).~The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.~The score is determined by asking the person with UC questions regarding:~bowel frequency at day/night~urgency of defecation~blood in stool~general health~extracolonic manifestations"|Baseline to Week 64 - open-label phase|FAS|||score on a scale||Full Range|Median
1391568|NCT01340872|Other Pre-specified|Change From Baseline in Simple Clinical Colitis Activity Index (SCCAI) Score at Week 12 (Full Analysis Set, FAS)|"Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 12 (FAS), end of double-blind phase (in subjects with UC).~The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.~The score is determined by asking the person with UC questions regarding:~bowel frequency at day/night~urgency of defecation~blood in stool~general health~extracolonic manifestations"|Baseline to Week 12 - double-blind phase|FAS - participants with UC only|||score on a scale||Full Range|Median
1391569|NCT01340872|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.~The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 64 - open-label phase|FAS|||score on a scale||Standard Deviation|Mean
1391570|NCT01340872|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.~The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 12 - double-blind phase|FAS|||score on a scale||Standard Deviation|Mean
1391571|NCT01340872|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||percent||Standard Deviation|Mean
1391572|NCT01340872|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||μg/dL||Standard Deviation|Mean
1391573|NCT01340872|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||μg/dL||Standard Deviation|Mean
1391574|NCT01340872|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||μg/dL||Standard Deviation|Mean
1391575|NCT01340872|Other Pre-specified|Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|FAS LOCF - sensitivity analysis of primary endpoint|||g/dL||Standard Error|Least Squares Mean
1391576|NCT01340872|Other Pre-specified|Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Per-Protocol Analysis Set - sensitivity analysis of primary endpoint|||g/dL||Standard Error|Least Squares Mean
1391577|NCT01340872|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||Participants|||Count of Participants
1391578|NCT01340872|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 36 (Full Analysis Set), after 12-week double-blind phase and 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||Participants|||Count of Participants
1391579|NCT01340872|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 16 (Full Analysis Set), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment|Baseline to Week 16 - open-label phase|FAS|||Participants|||Count of Participants
1391580|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the ‘Week 64’ visit was outside the visit window of 64 weeks ± 2 days|Baseline to Week 64 EOS - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1391585|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment|Baseline to Week 20 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1391586|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment.|Baseline to Week 16 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
1391587|NCT01340872|Secondary|Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)|ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|Baseline to Week 8 - double-blind phase|FAS|||g/dL||Standard Deviation|Mean
1391588|NCT01340872|Secondary|Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)|ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|Baseline to Week 4 - double-blind phase|FAS|||g/dL||Standard Deviation|Mean
1391589|NCT01340872|Secondary|Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 - end of double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
1391590|NCT01340872|Secondary|Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥2 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
1391591|NCT01340872|Secondary|Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase|Full Analysis Set (FAS)|||Participants|||Count of Participants
1391592|NCT01340872|Primary|Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate.|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
1391593|NCT01340794|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years.|Up to 5 years from registration|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable.|||months||95% Confidence Interval|Median
1391594|NCT01340794|Secondary|Progression-free Survival Time|Progression-free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Progression-free survival time will be estimated using the Kaplan-Meier method.|The time from registration to documentation of disease progression or death, whichever occurs first, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable|||months||95% Confidence Interval|Median
1391595|NCT01340794|Secondary|Overall Survival Time|Overall survival time is defined as the time from registration to death due to any cause and will be estimated using the Kaplan-Meier method.|The time from registration to death due to any cause, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable|||months||95% Confidence Interval|Median
1391596|NCT01340794|Secondary|Duration of Tumor Response|Defined for all patients whose tumor met the criteria of CR or PR (using the RECIST criteria) as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. None of the 4 patients that initiated treatment with a run-in responded||||||
1391606|NCT01340651|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard non-compartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Cmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.|||nM||Standard Deviation|Mean
1391597|NCT01340794|Primary|Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|"Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1) Ninety-five percent confidence intervals for the true response proportion was calculated using the exact binomial test.~Complete Response (CR): All of the following must be true:~Disappearance of all target and non-target lesions.~Each lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR):~At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking baseline measures as reference.~Overall Response (OR) was calculated by summing the number of patients with a CR or PR."|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable|||percentage of participants||95% Confidence Interval|Number
1391598|NCT01340768|Secondary|Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1391599|NCT01340768|Primary|Percentage of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1391600|NCT01340664|Secondary|Percentage of Patients With HbA1c <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of Participants|||Number
1391601|NCT01340664|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1391602|NCT01340664|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1391603|NCT01340664|Primary|Change in HbA1c From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1391604|NCT01340651|Secondary|Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. The area under the plasma concentration-time curve (AUC) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule for increasing concentrations and the log-trapezoidal rule for decreasing concentrations with the software WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA).|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.|||nM*h||Standard Deviation|Mean
1391605|NCT01340651|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard noncompartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Tmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.|||h||Full Range|Median
1391652|NCT01340573|Primary|Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391607|NCT01340651|Secondary|Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
1391608|NCT01340651|Secondary|Change From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms. A negative change score indicated improvement.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage change||Standard Deviation|Mean
1391609|NCT01340651|Secondary|Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
1391610|NCT01340651|Secondary|Change From Baseline in Spleen Length at Week 16|Spleen length was measured in centimeters by palpation.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage change||Standard Deviation|Mean
1391611|NCT01340651|Secondary|Change From Baseline in Spleen Volume at Week 16|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage change||Standard Deviation|Mean
1391612|NCT01340651|Primary|Overall Response (OR) at Week 16|The investigator graded OR according to the International Working Group for Myelofibrosis Research and Therapy criteria for treatment response. As bone marrow biopsies were not taken after baseline, the best achievable response was clinical improvement which required 1 of the following in the absence of progressive disease (PD): (1) A ≥ 2 g/dL increase in hemoglobin level or (2) either a palpable ≥ 50% reduction of splenomegaly of a spleen ≥ 10 cm at baseline or a spleen palpable at > 5 cm at baseline becoming not palpable. PD required 1 of the following: (1) Progressive splenomegaly defined by the appearance of previously absent splenomegaly that was palpable at > 5 cm below the left costal margin or a ≥ 100% increase in palpable distance for baseline splenomegaly of 5-10 cm or a ≥ 50% increase in palpable distance for baseline splenomegaly of > 10 cm or (2) an increase in peripheral blood blast percentage to ≥ 20% that lasted for ≥ 8 weeks. Stable disease: None of the above.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage of participants|||Number
1391613|NCT01340651|Primary|Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16||Baseline to Week 16|Safety population: All enrolled participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
1391614|NCT01340625|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.|||pg*h/mL||Standard Deviation|Mean
1391615|NCT01340625|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.|||pg*h/mL||Standard Deviation|Mean
1391616|NCT01340625|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.|||pg/mL||Standard Deviation|Mean
1391617|NCT01340625|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1391618|NCT01340625|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1391619|NCT01340625|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1391634|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1391620|NCT01340586|Other Pre-specified|Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation|"The number of participants who died or experienced SAEs or AEs leading to discontinuation was reported for each arm.~AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling."|From Day 1 to 30 days post study discontinuation|All treated participants|||participants|||Number
1391621|NCT01340586|Other Pre-specified|Number of Participants With Laboratory Marked Abnormalities|"ULN=Upper Limit of Normal, LLN=Lower Limit of Normal, Pre-Rx= Baseline value. BUN=Blood Urea Nitrogen (mmol/L=millimoles per Liter): High if BUN > 1.1*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx).~Platelet count (*10^9 cell/L): Low if Platelet Count < 0.85*LLN (if Pre-Rx<LLN: <0.85*Pre-Rx).~Creatine (umol/L=micromoles per Liter): High if Creatine > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Calcium, Total (mmol/L): High if Calcium > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Potassium, serum (mmol/L): High if Potassium > 1.1*ULN (if Pre-Rx>ULN: >1.1*Pre-Rx; if Pre-Rx<LLN: >ULN).~Phosphorus, Inorganic (mmol/L): Low if Phosphate < 0.85*LLN (if Pre-Rx>ULN: <LLN).~Lactate dehydrogenase (U/L=Units per Liter): High if Lactate Dehydrogenase > 1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)."|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||participants|||Number
1391622|NCT01340586|Secondary|Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban|Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||IU/mL||Standard Deviation|Mean
1391623|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban|The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||maximum percent change from baseline||Standard Deviation|Mean
1391624|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||maximum percent change from baseline||Standard Deviation|Mean
1391625|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||maximum percent change from baseline||Standard Deviation|Mean
1391626|NCT01340586|Primary|Percentage of BMS-730823 Extracted During Hemodialysis|The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||percentage of BMS-730823 extracted||Standard Deviation|Mean
1391627|NCT01340586|Primary|Percentage of Apixaban Extracted During Hemodialysis|The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||percentage of apixaban extracted||Standard Deviation|Mean
1391628|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of BMS-730823|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis|||mL/min||Standard Deviation|Mean
1391629|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of Apixaban|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1391630|NCT01340586|Primary|Mean Renal Clearance (CLR) of BMS-730823|Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1391631|NCT01340586|Primary|Mean Renal Clearance (CLR) of Apixaban|Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1391632|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)|Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||percent of dose recovered in dialysate||Standard Deviation|Mean
1391633|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Urine (%UR)|The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered.|24 hours pre-dose to 72 hours post-dose|All treated participants|||percent of dose recovered in urine||Standard Deviation|Mean
1391635|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1391636|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823|Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||hours||Full Range|Median
1391637|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban|Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||hours||Full Range|Median
1391638|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of BMS-730823|Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data.|24 hours pre-dose to 72 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||hours||Standard Deviation|Mean
1391639|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban|Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||hours||Standard Deviation|Mean
1391640|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*h/mL||Standard Deviation|Mean
1391641|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1391642|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1391643|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1391644|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391645|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391646|NCT01340573|Secondary|Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire|Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.|Week 12|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391647|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391648|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment||Week-48|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391649|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391650|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment|Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391651|NCT01340573|Primary|Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391653|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up|Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391654|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment|Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-48|The study was terminated early due to low enrollment. This analysis was not performed.||||||
1391655|NCT01340495|Secondary|Progression Free Survival|Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions.|from the start of treatment until the time of disease progression, up to 5 years||2023-01-31|01/2023||||
1391656|NCT01340495|Secondary|The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy|The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.|Baseline and then 4 and 8 weeks post treatment|One participant withdrew from the trial before the start of treatment and was not included in the analysis population.|||Participants|||Count of Participants
1391657|NCT01340495|Secondary|The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction||From the start of treatment until 5 years post treatment||2023-01-31|01/2023||||
1391658|NCT01340495|Secondary|Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation|Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From the start of treatment until 5 years post treatment||2023-01-31|01/2023||||
1391659|NCT01340495|Secondary|To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome||From the start of treatment until 5 years post treatment||2023-01-31|01/2023||||
1391660|NCT01340495|Secondary|Summary of Late Skin Toxicity|A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From 3 months after the end of treatment up to 5 years||2023-01-31|01/2023||||
1391661|NCT01340495|Secondary|Rate and Severity of Radiation Pneumonitis|"The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).~Grade 1: Mild~Grade 2: Moderate~Grade 3: Severe~Grade 4: Life-Threatening~Grade 5: Fatal"|From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.|One participant withdrew from the trial before the start of treatment and was not included in the analysis population.|||Participants|||Count of Participants
1391662|NCT01340495|Secondary|The Number of Participants With Acute Skin Toxicities|Summary of the acute skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From the start of treatment until 3 months after the end of treatment||2018-05-31|05/2018||||
1391663|NCT01340495|Primary|Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event|To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.|From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks|One participant withdrew from the trial before the start of treatment and was not included in the analysis population.|||Participants|||Count of Participants
1391664|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - Waist to Hip Ratio|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.|||ratio||Standard Error|Least Squares Mean
1391665|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - BMI|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.|||kg/m^2||Standard Error|Least Squares Mean
1391666|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - Weight|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.|||kg||Standard Error|Least Squares Mean
1391667|NCT01340300|Secondary|Change in Fasting Glucose Level|Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting Glucose level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting Glucose levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.|||mg/dL||Standard Error|Least Squares Mean
1391668|NCT01340300|Secondary|Changes in Other Insulin-Related Biomarkers|Markers related to insulin and insulin-like growth factors (including insulin-like growth factor 1 [IGF-1], IGF binding protein-1 [IGFBP-1], IGF binding protein-3 [IGFBP-3], leptin) will be measured by a blood draw at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.|||ng/mL||Standard Error|Least Squares Mean
1391669|NCT01340300|Primary|Change in Fasting Insulin Level|Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting insulin level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.|||mU/L||Standard Error|Least Squares Mean
1391670|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms During the Day (Response)|"Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline.~5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set|||Scores on a scale||Standard Deviation|Mean
1391671|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms in the Morning (Response)|"Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline.~5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set|||Scores on a scale||Standard Deviation|Mean
1391672|NCT01340209|Secondary|Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)|Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.|baseline and week 52|Full analysis set|||Puffs||Standard Deviation|Mean
1391673|NCT01340209|Secondary|Weekly Mean PEF Variability Response|"Weekly mean PEF variability response was defined as change from baseline at week 52.~The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline."|baseline and week 52|Full analysis set|||percentage||Standard Error|Least Squares Mean
1391674|NCT01340209|Secondary|Weekly Mean PEFpm Response|Weekly mean PEFpm response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||L/min||Standard Error|Least Squares Mean
1391675|NCT01340209|Secondary|Weekly Mean PEFam Response|Weekly mean PEFam response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||L/min||Standard Error|Least Squares Mean
1391676|NCT01340209|Secondary|Trough PEF Response|Trough PEF response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||L/min||Standard Error|Least Squares Mean
1391677|NCT01340209|Secondary|Trough FVC Response|Trough FVC response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||Liter||Standard Error|Least Squares Mean
1391678|NCT01340209|Secondary|Trough FEV1 Response|Trough FEV1 response was defined as change from baseline at week 52|baseline and week 52|Full analysis set: all patients of the treated set for which baseline and at least 1 post-baseline efficacy measurement were available|||Liter||Standard Error|Least Squares Mean
1391679|NCT01340209|Primary|Number of Patients With Drug-related Adverse Events|The primary endpoint is the number of patients with drug-related adverse events|after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409|Treated set: all randomised patients who received at least 1 dose of study medication|||participants|||Number
1391680|NCT01340196|Secondary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG|"Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.~Preferred term of relevant AE: Presyncope"|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).|||participants|||Number
1391681|NCT01340196|Secondary|Number of Patients With Drug Related Adverse Events During the Trial|Outcome data are the numbers of subjects with investigator defined drug-related AEs|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).|||participants|||Number
1391682|NCT01340196|Primary|Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22|Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391683|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391684|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1391728|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set|||Number of subjects|||Number
1391685|NCT01340196|Primary|Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15|Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391686|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391687|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects who were documented to have taken at least one dose of trial medication (treated set) who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1391688|NCT01340144|Primary|Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject.|The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication.|Two years after TKA (Total Knee Arthroplasty) procedure||||participants|||Number
1391689|NCT01340066|Primary|Percentage of Participants With a Decrease in Leakage Events of 30% or More.|Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period.|Change from baseline after 4 weeks of treatment.||||Percentage of participants|||Number
1391690|NCT01340027|Secondary|Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
1391691|NCT01340027|Secondary|Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant’s assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant’s assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1391692|NCT01340027|Secondary|Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1391693|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
1391694|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
1391695|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|"The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
1391696|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
1391697|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
1391698|NCT01340027|Secondary|Percentage of Participants With a Health-related Quality of Life Total Score Response|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||percentage of participants|||Number
1391699|NCT01340027|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
1391700|NCT01340027|Secondary|Percentage of Participants With a Symptom Bother Response|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||percentage of participants|||Number
1391701|NCT01340027|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
1391702|NCT01340027|Secondary|Percentage of Participants With Deterioration in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||percentage of participants|||Number
1391703|NCT01340027|Secondary|Percentage of Participants With Major Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||percentage of participants|||Number
1391704|NCT01340027|Secondary|Percentage of Participants With Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||percentage of participants|||Number
1392410|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator’s Live Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment|||percentage of subjects|||Number
1391705|NCT01340027|Secondary|Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
1391706|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours|Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one nocturia episode at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||nocturia episodes||Standard Error|Least Squares Mean
1391707|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours|The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one use of pad at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||pads||Standard Error|Least Squares Mean
1391708|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Level of Urgency|Average of participants’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||units on a scale||Standard Error|Least Squares Mean
1391709|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||urgency episodes||Standard Error|Least Squares Mean
1391710|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence participants who had at least 1 urgency (grade 3 or 4) incontinence episode at Baseline, including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||urgency incontinence episodes||Standard Error|Least Squares Mean
1391711|NCT01340027|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes|The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."|||percentage of participants|||Number
1391712|NCT01340027|Secondary|Percentage of Participants With Zero Incontinence Episodes Post-baseline|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.|Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."|||percentage of participants|||Number
1391713|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n)."|||incontinence episodes||Standard Error|Least Squares Mean
1391714|NCT01340027|Secondary|Percentage of Participants With a Micturition Response|A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants with at least 8 micturitions per 24 hours at Baseline and including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."|||percentage of participants|||Number
1391715|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n)."|||micturitions||Standard Error|Least Squares Mean
1391716|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n).."|||mL||Standard Error|Least Squares Mean
1391717|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set-Incontinence comprised participants in the FAS who reported at least 1 incontinence episode in the baseline diary. LOCF was used.|||incontinence episodes||Standard Error|Least Squares Mean
1391718|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set; LOCF was used.|||micturitions||Standard Error|Least Squares Mean
1391719|NCT01340027|Primary|Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set (FAS) comprised all participants took at least 1 dose of double-blind study medication after randomization and had primary efficacy data (mean volume voided) derived from the diary at Baseline and at least 1 post-baseline visit. Last observation carried forward imputation (LOCF) was utilized.|||mL||Standard Error|Least Squares Mean
1391720|NCT01340014|Secondary|Ocular Discomfort|Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).|Day 7 of each period|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated, minus any missing responses.|||Units on a scale||Standard Deviation|Mean
1391721|NCT01340014|Primary|Preferred Treatment|"The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer? Preferred treatment is presented as a percentage."|At the end of both periods, Day 15|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated.|||Percentage of participants|||Number
1391722|NCT01339936|Secondary|Ocular Surface Disease Index Score|"The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient’s ability to function.~The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability."|after 30 days of eye drop usage||||points||Standard Deviation|Mean
1391723|NCT01339936|Secondary|Tear Break Up Time|The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35|||seconds||Standard Deviation|Mean
1391724|NCT01339936|Primary|Tear Film Evaporation Rate|The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10^-7 g/cm^2 /s and recorded for relative humidity of 25% to 35%.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35|||10^-7g/cm^2/sec||Standard Deviation|Mean
1391725|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on unsolicited safety set.|Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)|Unsolicited safety set|||Number of subjects|||Number
1391726|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ. Analysis was done on unsolicited safety set.|Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)|Unsolicited safety set|||Number of subjects|||Number
1391727|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set.|Until 12 months of age; Day 1 to day 7 (All AEs)|Unsolicited safety set|||Number of subjects|||Number
1391729|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set|||Number of subjects|||Number
1391730|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set|||Number of subjects|||Number
1391731|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set|||Number of subjects|||Number
1391732|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set|||Number of subjects|||Number
1391733|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ|Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set.|||Number of subjects|||Number
1391734|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence|Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence|||IU/mL||95% Confidence Interval|Geometric Mean
1391735|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-primary and FAS-booster|||IU/mL||95% Confidence Interval|Geometric Mean
1391736|NCT01339923|Secondary|GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-persistence and FAS-booster|||Titers||95% Confidence Interval|Geometric Mean
1391737|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination and 1 month after booster vaccination|FAS-primary series and FAS-booster|||Percentages of subjects||95% Confidence Interval|Number
1391738|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence|||Titers||95% Confidence Interval|Geometric Mean
1391739|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination, 1 month after booster vaccination|FAS-primary series and FAS-booster|||Titers||95% Confidence Interval|Geometric Mean
1391740|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster.|Baseline, 1 month after second vaccination and 1 month after booster vaccination|PPS-primary series and PPS-booster.|||Percentages of subjects||95% Confidence Interval|Number
1391741|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series|||IU/mL||95% Confidence Interval|Geometric Mean
1392973|NCT01329679|Primary|Change in Office Systolic Blood Pressure|SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.|At baseline and 7 days post energy drink and placebo consumption||||mmHg||Standard Deviation|Mean
1391742|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster.|1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination|FAS-persistence and FAS-booster|||IU/mL||95% Confidence Interval|Geometric Mean
1391743|NCT01339923|Secondary|Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence|||Titers||95% Confidence Interval|Geometric Mean
1391744|NCT01339923|Secondary|Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence|||Percentages of subjects||95% Confidence Interval|Number
1391745|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B_2h3h5_11 and 3rd dose for B_3h5_11 and B_68_11). Analysis was done on FAS-booster.|1 month post-booster dose|FAS-booster|||Percentages of subjects||95% Confidence Interval|Number
1391746|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose.|Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)|FAS-post first dose|||Percentages of subjects||95% Confidence Interval|Number
1391747|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV.|Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (after 1 month for group B_2h3h5_11b, 1.5 months for group B_2h3h5_11b and 2 months for group B_68_11b). Analysis was done on FAS-post first dose.|1, 1.5 or 2 months after first infant vaccination|FAS-post first dose|||Titers||95% Confidence Interval|Geometric Mean
1391748|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV|"Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B_2h3h5_11 and 1 month after 2nd infant vaccination in B_3h5_11, B_68_11 and B_02).~Analysis was done on FAS-primary series."|1 month after primary series vaccination|FAS-primary series|||Titers||95% Confidence Interval|Geometric Mean
1391749|NCT01339923|Secondary|Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|"Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule).~Analysis was done on FAS- primary series."|1 month after second vaccination|FAS- primary series|||Percentages of subjects||95% Confidence Interval|Number
1391750|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series|||Percentages of subjects||95% Confidence Interval|Number
1391751|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series.|1 month after third vaccination|FAS-primary series|||Percentages of subjects||95% Confidence Interval|Number
1391752|NCT01339923|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.|1 month after second vaccination|FAS-Primary series|||Percentages of subjects||97.5% Confidence Interval|Number
1394121|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1391753|NCT01339910|Secondary|Number of Participants With Cause of Death|Primary cause of death was adjudicated using previously described criteria (Copelan et al. 2007). When relapse occurred, it was considered the primary cause of death regardless of other events.|18 months post-randomization||||Participants|||Count of Participants
1391754|NCT01339910|Secondary|Number of Participants With Infections|"The maximum severity of infections reported by participants are tabulated.~The number of infections and the number of patients experiencing infections will be tabulated by type of infection, severity, and time period after transplant. The cumulative incidence of severe, life-threatening, or fatal infections will be compared between the two treatment arms at 6, 12, and 18 months from transplant or until death."|18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
1391755|NCT01339910|Secondary|Infection Type|The number and types of infection events reported are tabulated.|18 months post-transplant|Infection events|||Infection events|Infection events||Count of Units
1391756|NCT01339910|Secondary|Number of Participants With Maximum Grade 3-5 Toxicities|"The maximum grade of toxicities reported by participants over the study duration are tabulated. Per the CTCAE criteria, toxicities are graded on a scale of 0-5, with higher numbers indicating greater severity. The categories correspond as follows:~3 - severe; 4 - life-threatening; 5 - fatal"|18 months|Transplanted participants|||Participants|||Count of Participants
1391757|NCT01339910|Secondary|Number of Participants With Secondary Graft Failure|Secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in neutrophil counts to less than 500x10^6/liter that is unresponsive to growth factor therapy.|18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
1391758|NCT01339910|Secondary|Number of Participants With Primary Graft Failure|Primary graft failure is defined by lack of neutrophil engraftment.|28 days post-transplant|Transplanted participants|||Participants|||Count of Participants
1391759|NCT01339910|Secondary|Number of Participants With Chronic GVHD Severity|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe.|18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
1391760|NCT01339910|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification.|18 months post-transplant|Transplanted participants|||percentage||95% Confidence Interval|Number
1391761|NCT01339910|Secondary|Percentage of Participants With Acute Graft Versus Host Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 100 post-transplant|Transplanted participants|||percentage||95% Confidence Interval|Number
1391762|NCT01339910|Secondary|Number of Participants With Donor Cell Engraftment|Donor cell engraftment will be assessed by donor-recipient chimerism assays. Full donor chimerism is defined as the presence of at least 95% donor cells as a proportion of the total population in the peripheral blood or bone marrow. Graft rejection is defined as the presence of no more than 5% donor cells as a proportion of the total population. Mixed chimerism is defined as the presence of between 5% and 95% donor cells. Mixed or full donor chimerism will be considered evidence of donor engraftment.|Days 28 and 100 and 18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
1391763|NCT01339910|Secondary|Percentage of Participants With Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for 3 consecutive measurements on different days. The first of the 3 days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 20,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.|Days 28 and 60 post-transplant|Transplanted participants|||percentage|||Number
1391764|NCT01339910|Secondary|Percentage of Participants With Treatment-related Mortality|Treatment-related mortality is defined as death without a previous relapse of the primary disease.|18 months post-randomization||||percentage||95% Confidence Interval|Number
1391765|NCT01339910|Secondary|Percentage of Participants With Disease Relapse|Disease Relapse is defined as relapse of the primary disease.|18 months post-randomization||||percentage||95% Confidence Interval|Number
1391766|NCT01339910|Secondary|Percentage of Participants With Relapse-Free Survival (RFS)|Relapse-free survival is defined as survival without relapse of the primary disease.|18 months post-randomization||||percentage||95% Confidence Interval|Number
1391767|NCT01339910|Primary|Percentage of Participants With Overall Survival (OS)|Overall survival is defined as survival of death from any cause.|18 months post-randomization||||percentage||95% Confidence Interval|Number
1391768|NCT01339897|Secondary|Pharmacokinetics of N6022 Cmax Values on Study Day 7|Pharmacokinetic Analysis of N6022 Cmax values on Study Day 7|Day 7, 24 hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391769|NCT01339897|Secondary|Pharmacokinetics of N6022 on Study Day 1|Analysis of N6022 Cmax values on Study Day 1|Day 1, 24 hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391770|NCT01339897|Secondary|Pharmacokinetics of N6022 Over 7 Days|Analysis of N6022 AUC0-tau values from Study Day 7|Day 7, 24 hours|N6022 AUC0-tau values from Study Day 7|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391771|NCT01339897|Secondary|Pharmacokinetics of N6022|N6022 AUC0-tau measurements from Day 1|Day 1, 24 hours|Any subject that completed N6022 or placebo PK sampling|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391772|NCT01339897|Primary|Safety of Escalating Multiple Doses of N6022 in Healthy Subjects|Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)|Over 7 days|Any subject that received any dose of N6022 or placebo.|||participants|||Number
1391773|NCT01339832|Secondary|Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
1391774|NCT01339832|Secondary|Long Term Side Effects|Long term side effects for bowel and urinary function was assessed. Bowel function was assessed in terms of mean bowel frequency, regular use of constipating agents as well as fecal incontinence. Urinary function was evaluated according to the presence (YES or NO) of incontinence. Overall participant satisfaction was assessed in terms of satisfaction with bowel, stoma and urinary function on a 4-stage scale (very good, good, poor, and very poor). In case of different assessment(s) of bowel or urinary function within the same surveillance period, the assessment with worst grade was documented and reported.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
1391775|NCT01339832|Secondary|Compliance to Diagnostic Procedures in Surveillance|The surveillance compliance was calculated per participant in percent and frequencies for methods of diagnostic procedure adhered to, taking into account all expected procedures in the time span the participant participated and was based on the Swiss Society of Gastroenterology (SGG) follow-up care recommendations|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
1391776|NCT01339832|Secondary|Length of Adjuvant Chemotherapy|The length of adjuvant chemotherapy was defined as time between first start date to last stop date of adjuvant chemotherapy regimen. Length of adjuvant chemotherapy was calculated as length [days] = last stop date - first start date + 1, missing day of start and stop date was replaced by 1.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||days||Full Range|Median
1391777|NCT01339832|Secondary|Type of Adjuvant Chemotherapy|The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
1391778|NCT01339832|Secondary|Tumor Recurrence Rate (Local and Distant)|Participant with tumor recurrence were determined by the presence or absence of date of tumor recurrence detection. In case of absence of empty tumor recurrence date it was considered that the participant had not experienced tumor recurrence. Participants with local tumor recurrence (’Was it local to the primary tumor?’ answered ‘yes’.) compared to participants with distant tumor recurrence (specification for other tumor location given).|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
1391779|NCT01339832|Secondary|Overall Survival|Overall survival (OS) was defined as time from date of first administration of the study medication in ML18280 study to date of death from any cause. Participants without documented date of death were assumed to be alive and were censored at the latest of the following dates: last date alive on survival status pages, last date known to be alive on survival status pages, and last date of tumor assessment (diagnostic procedures or markers) on surveillance pages. OS time in days was calculated as OS [days] =date of death date of first intake+ 1, for participants who died, OS [days]= censoring date date of first intake+ 1, for participants alive, and OS time in months was calculated as OS [months]= 12 *OS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||months||Full Range|Median
1391780|NCT01339832|Primary|Progression-free Survival|Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause. In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance). PFS time in days was calculated as PFS [days]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS [days] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS [months]= 12 * PFS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||months||Full Range|Median
1391781|NCT01339429|Secondary|Number of Participants With Serious Adverse Events|Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.|3 days||||participants|Participants||Number
1391782|NCT01339429|Primary|Maintenance of Negative Pressure|The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.|3 days|85 dressings were applied. 5 applications excluded due to a change in patient condition, unrelated to sNPWT. 9 dressings excluded due to occlusion of the drainage tube. 71 dressings were analyzed in total.|||hours|Participants|Standard Deviation|Mean
1391783|NCT01339416|Secondary|Incidence Rate of Death|Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses.|Up to Week 626|Analysis population included all participants enrolled in the study.|||death per 100 person-years||95% Confidence Interval|Number
1391784|NCT01339416|Secondary|Incidence Rate of Rhabdomyolysis|Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown.|Up to Week 626|Analysis population included all participants enrolled in the study.|||rhabdomylosis per 100 person-years||95% Confidence Interval|Number
1391785|NCT01339416|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus.|Up to Week 626|Analysis population included all participants enrolled in the study.|||viral encephalitis per 100 person-years||95% Confidence Interval|Number
1391786|NCT01339416|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.|||liver failure per 100 person-years||95% Confidence Interval|Number
1391787|NCT01339416|Primary|Incidence Rate of Myocardial Infarction|Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.|||MI per 100 person-year||95% Confidence Interval|Number
1391788|NCT01339416|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.|Up to Week 626|Analysis population included all participants enrolled in the study.|||infections per 100 person-years||95% Confidence Interval|Number
1391789|NCT01339416|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin’s disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years.|Up to Week 626|Analysis population included all participants enrolled in the study. Here, n=participants who were evaluable for this measure at given time points for each group, respectively.|||malignancies per 100 person-years||95% Confidence Interval|Number
1391790|NCT01339403|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).|Up to Week 730|Analysis population included all participants enrolled in the study.|||VE per 100,000 person-years|||Number
1391791|NCT01339403|Primary|Incidence Rate of All-Cause Mortality|Incidence rate of all-cause mortality was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||death per 100,000 person-years|||Number
1394122|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1391792|NCT01339403|Primary|Incidence Rate of Rhabdomyolysis|Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||rhabdomyolysis per 100,000 person-years|||Number
1391793|NCT01339403|Primary|Incidence Rate of Liver Related Death|Incidence rate of liver related death was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||death per 100,000 person-years|||Number
1391794|NCT01339403|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||liver failure per 100,000 person-years|||Number
1391795|NCT01339403|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||infections per 100,000 person-years|||Number
1391796|NCT01339403|Primary|Incidence Rate of Myocardial Infarction and Ischemia|Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||CVS events per 100,000 person-years|||Number
1391797|NCT01339403|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||malignancies per 100,000 person-years|||Number
1391798|NCT01339390|Primary|Change in Weight (From Baseline)|Weight as recorded in the medical record during a 6-month period around the follow-up point.|Measured at 12 and 24 months|For the analysis, we included those lost to follow up by using the last observation carried forward to impute missing values|||Pounds||Standard Deviation|Least Squares Mean
1391799|NCT01339299|Primary|The Oestradiol Concentration on the Day of Ovulation Induction||treatment day 10 to 14||||pmol/L||Standard Deviation|Mean
1391800|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||0-120 hours|FAS|||percentage of responders||95% Confidence Interval|Number
1391801|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1||0-24 hours|FAS|||percentage of responders||95% Confidence Interval|Number
1391802|NCT01339260|Primary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||25-120 hours|FAS|||percentage of responders||95% Confidence Interval|Number
1391803|NCT01339247|Primary|Cmax_ss|Cmax_ss is defined as the maximum or “peak” concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population|||ng/ml||Standard Deviation|Mean
1391804|NCT01339247|Primary|Cmin_ss|Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population|||ng/ml||Standard Deviation|Mean
1391830|NCT01339000|Primary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on Specific Immune Responses to Vaccines (in Particular to Neo Antigens) in Older Subjects Following Chemotherapy||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
1391805|NCT01339247|Primary|AUC_ss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population|||ng.h/ml||Standard Deviation|Mean
1391806|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
1391807|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
1391808|NCT01339091|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
1391809|NCT01339091|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
1391810|NCT01339052|Secondary|Grade 3-5 Treatment-Related Toxicity Rate|The percentage of patients who experienced any grade 3-5 treatment-related adverse event based on CTCAEv4 as reported on case report forms.|Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.|The analysis dataset is comprised of all treated patients.|||percentage of patients||90% Confidence Interval|Number
1391811|NCT01339052|Secondary|Progression-Free Survival (PFS) [Cohort 2]|PFS is defined as the time from first dose to the earliest documentation of disease progression or death. Participants alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). See outcome measure #2.|Participants were assessed radiologically every other cycle on treatment and off-treatment via medical record review until death. Cohort 2 participants were followed for progression-free survival up to 12 months in this study cohort.|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
1391812|NCT01339052|Secondary|Overall Survival (OS) [Cohort 2]|Overall survival is defined as the time from date of first dose to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Participants were followed long-term for survival via medical record review. Cohort 2 participants were followed for survival up to 52 months in this study cohort.|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
1391813|NCT01339052|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of BKM120 Day 1 and Day 8 [Cohort 1]|Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||hours||Full Range|Median
1391814|NCT01339052|Secondary|AUC0-5h Accumulation Ratio of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.~The accumulation ratio is day 8/day 1."|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ratio day 8/day 1||Full Range|Mean
1391815|NCT01339052|Secondary|Area Under the Concentration Curve From Time 0 to Last Concentration (AUC0-5h) of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.~NOTE: This outcome measure was previously titled: Investigate Pharmacokinetics of BKM120 in This Population by Comparing the Drug Exposure Area Under the Curve (AUC0-5h) From Day 1 to Day 8”"|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ug*h/mL||Standard Deviation|Mean
1391816|NCT01339052|Secondary|Cmax Accumulation Ratio of BKM120 Day 1 and Day 8 Ratio [Cohort 1]|Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods. The accumulation ratio is day 8/day 1.|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ratio day 8/day 1||Full Range|Mean
1391817|NCT01339052|Secondary|Maximum Observed Plasma Concentrations (Cmax) of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.~NOTE: This outcome measure was previously titled: Investigate Pharmacokinetics of BKM120 in This Population by Comparing Maximum Plasma Concentrations (Cmax) From Day 1 to Day 8”"|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ng/mL||Standard Deviation|Mean
1391818|NCT01339052|Secondary|Radiographic Response [Cohort 2]|Radiographic response was based on RANO (Response Assessment in Neuro-Oncology) criteria. Per RANO, complete response (CR): 1) Complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks, 2) No new lesions, 3) All lesions assessed using the same techniques as baseline, 4) No steroid use (or on physiologic replacement doses only), 5) Stable or improved non-enhancing (T2/FLAIR) lesions and 6) Stable or improved clinically; partial response (PR): 1) >/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sum LD) sustained for at least 4 weeks and 2) No progression; progressive disease (PD): 1) > 25% increase sum LD and/or 2) significant increase in T2/FLAIR, 3) any new lesion, 4) clear clinical deterioration; stable disease (SD): none of the above.|Participants were assessed radiologically every other cycle on treatment. Cohort 2 participants were on treatment up to 9.2 months.|Only those participants who had measurable disease present at baseline and received at least one dose of therapy are considered evaluable for radiographic response|||Participants|||Count of Participants
1391819|NCT01339052|Secondary|% Ki-67 Reduction Using Immunohistochemistry (IHC) [Cohort 1]|Tumor cell proliferation and tumor cell death was using immunohistochemistry for Ki-67 based on established methods. Percent reduction was based on Ki-67 levels at baseline and at surgery.|Samples were collected at baseline (archival tumor specimen) and at surgery (surgical tumor specimen) which occurred after up to 12 days of BTK120 treatment.|The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).|||% reduction||Full Range|Median
1391820|NCT01339052|Primary|BKM120 Plasma Concentration at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.|Samples were collected at surgery which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all participants with a plasma sample at surgery (evaluable).|||ng/mL||Standard Deviation|Mean
1391821|NCT01339052|Primary|BKM120 Tumor Tissue Concentration at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.|Samples were collected at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).|||ng/gm||Full Range|Geometric Mean
1391822|NCT01339052|Primary|BKM120 Brain-to-Plasma Ratio at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry. BKM120 tumor-to-plasma ratio at time of surgery was calculated based on these levels.|Samples were collected at surgery (surgical tumor specimen and plasma sample) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of participants with a paired plasma and brain tumor sample (evaluable). Participants missing a brain tumor sample (n=1) or plasma sample (n=2) are excluded from the calculation.|||ratio tumor-to-plasma||Full Range|Geometric Mean
1391823|NCT01339052|Primary|6-Month Progression-Free Survival (PFS6) [Cohort 2]|PFS6 is the proportion of participants remaining alive and progression-free at 6-months from cycle 1 day 1 of BKM120 treatment. Progressive disease is defined using RANO (Response Assessment in Neuro-Oncology) criteria (Wen et al JCO 2010), which takes modified Macdonald Criteria and adds assessment of non-enhancing lesions. Per RANO, progressive disease (PD) is defined either as > 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable or increasing doses of corticosteroids, or one or more of the of the following: 1) Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids steroids not due to co-morbid events; 2) Any new lesion; 3) Clear clinical deterioration not attributable to other causes apart from the tumor; or 4) Failure to return for evaluation due to death or deteriorating condition.|Participants were assessed radiologically every other cycle on treatment; Relevant for this outcome is up to month 6 evaluation.|The analysis dataset is comprised of all treated participants.|||proportion of participants||90% Confidence Interval|Number
1391824|NCT01339052|Primary|Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]|pAKT response was determined by pathologist-performed semi-quantitative IHC scoring for pAKT using previously established methods for glioblastoma (GBM) patients. Sample staining scored for intensity on a 0-2+ scale (0 none, 1+ weak positive, 2+ strong positive). Change in pAKT IHC score was the difference in score from baseline to surgery. Participants were classified into 3 groups: a reduction of staining score of one degree or more (considered a response), an increase in score and no change in score.|Samples were collected at baseline and at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all treated participants.|||Participants|||Count of Participants
1391825|NCT01339013|Primary|Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.|A conventional heat and moisture exchanger used in a respiratory circuit during anasthesia was exchanged by an AnaConDa. The AnaConDa causes re-breathing of carbon dioxide which clinically is equivalent to an increased airway dead space. The total airway dead space effect of the AnaConDa, i.e. volume of the device plus rebreathing from the charcoal filter was measured using the Single Breath Test for carbon dioxide, as was airway deadspace of the conventional Heat and Moisture Exchanger. Airway dead space differences between devices was calculated by subtraction of volumes thus achieved. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger.|1 hour||||mL||95% Confidence Interval|Median
1391826|NCT01339000|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|12 months||||participants|||Number
1391827|NCT01339000|Secondary|Based on the First Two Primary Objectives, Consider and Discuss the Need for Larger Studies to Evaluate the Potential Benefit of Interleukin-7 (CYT107) Administration in a Broad, Mass Protection Strategy for an Aging Population||1 year|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
1391828|NCT01339000|Secondary|Evaluate the Effects of Interleukin-7 (CYT107) Therapy on the Quality of T Cell Specific Responses by Multiparameter Flow Cytometry||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
1391829|NCT01339000|Secondary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on the T Cell Receptor Diversity in Older Subjects Following Chemotherapy||10 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
1391831|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% loss in body weight from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
1391832|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
1391833|NCT01338870|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||kilogram (kg)||Standard Deviation|Mean
1391834|NCT01338870|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes, and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
1391835|NCT01338870|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||percentage of hemoglobin||Standard Deviation|Mean
1391836|NCT01338870|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1391837|NCT01338870|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||percentage of hemoglobin||Standard Deviation|Mean
1391838|NCT01338857|Primary|Objective Response Rates|Determination of tumor response (CR, PR, SD) will be defined based on the comparison of the baseline MRI performed at study entry to the subsequent MRI which demonstrated best response. PR will be defined by a >15% decrease in tumor volume, as measured by 3D volumetric analysis.|MRIs performed after every 3rd 28-day cycle and off-study|Study terminated and 1/12 participants completed and data was analyzed|||participants|||Number
1391839|NCT01338857|Primary|Response Rate to Sorafenib|To estimate the objective response rates to sorafenib in children and young adults with low-grade astrocytomas, including optic pathway gliomas.|one year|Study terminated and 1/12 participants completed and data was analyzed|||participants|||Number
1391840|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score|SDS,5-self-rated questionnaire to measure the extent a pt’s disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.|||Scores on a scale||Standard Deviation|Mean
1391855|NCT01338636|Primary|Change From Baseline in Peak Exercise Pulmonary Vascular Compliance (PVC )|PVC is a measure of a pulmonary vein's ability to expand.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||mL/mmHg||Standard Deviation|Mean
1391856|NCT01338636|Primary|Change From Baseline in Peak Exercise Pulmonary Vascular Resistance (PVR)|PVR is the resistance offered by the pulmonary circulatory system.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||Woods units (WU)||Standard Deviation|Mean
1391841|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (rarely or never) to 3 (Very often). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing."|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.|||scores on a scale||Standard Deviation|Mean
1391842|NCT01338818|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths.|Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.|Week 40 - Week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.|||participants|||Number
1391843|NCT01338792|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 year|All participants who started treatment were included.|||Participants|||Number
1391844|NCT01338792|Secondary|Time to Disease Progression and Overall Survival|Progression-free survival was defined as the time from the first infusion of study treatment to the date of radiographic disease progression according to RECIST 1.0, or until two consecutive PSA rises occurred with an absolute increase of 5 ng/mL and a 50% relative increase over baseline. For patients without documented disease progression, the date of death or last follow-up without disease progression was used.|Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progression|Participants who received at least the first infusion of treatment were included.|||Months||95% Confidence Interval|Mean
1391845|NCT01338792|Primary|Best Overall Response|For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = <30% decrease or <20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.|RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year|All participants who received at least 1 cycle of treatment were included.|||Participants|||Number
1391846|NCT01338649|Secondary|MSLT and Polysomnograph (PSG) Testing Will be Compared.|MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.|4 weeks|||||||
1391847|NCT01338649|Secondary|Actigraphy Measures Including Total Sleep Time, Sleep Efficiency, Sleep Fragmentation Index, Frequency of Naps, and Mean Activity Level (a Measurement of Daytime Function) Will be Collected.|Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.|6 weeks|||||||
1391848|NCT01338649|Secondary|The Global PSQI Score and PDSS Score Will be Compared.|The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.|6 weeks|||||||
1391849|NCT01338649|Primary|Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.|ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.|baseline and 4 weeks||||score||Standard Deviation|Mean
1391850|NCT01338636|Secondary|World Health Organization Functional Class (WHO FC)|The WHO FC categorizes cardiac disability using four classes, ranging from Class 1 (without limitation of physical activity) to Class 4 (inability to carry on any physical activity without discomfort).|Baseline and Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||class||Standard Deviation|Mean
1391851|NCT01338636|Secondary|Borg Dyspnea Scale Score|The Borg Dyspnea Scale measures how breathless the participant feels. Scores range from 0 (no shortness of breath) to 10+ (more short of breath than ever experienced). A score greater that 10 represents very extreme shortness of breath.|Baseline and Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||score on a scale||Standard Deviation|Mean
1391852|NCT01338636|Secondary|Change From Baseline in 6-minute Walk Distance (6MWD)|6MWD is the distance walked by the participant in 6 minutes.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||meters||Standard Deviation|Mean
1391853|NCT01338636|Primary|Change From Baseline in Peak Exercise Maximum Oxygen Uptake (VO2max)|VO2max is the measurement of the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||percent predicted||Standard Deviation|Mean
1391854|NCT01338636|Primary|Change From Baseline in Peak Exercise Cardiac Output (CO)|CO is the amount of blood pumped by the heart per minute.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||L/min||Standard Deviation|Mean
1391857|NCT01338636|Primary|Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP)|mPAP is measure of the blood pressure found in the main artery of the lung. TPG is the difference between mean pulmonary arterial pressure and left atrial pressure. PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||mmHg||Standard Deviation|Mean
1391858|NCT01338610|Primary|Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28|An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).|Up to 28 days|All subjects randomized to treatment and receiving at least 1 administration of study medication (intent-to-treat). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.|||Units on a scale x days||Standard Error|Least Squares Mean
1391859|NCT01338493|Secondary|Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)|"Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced.~0 = no pain, 10 = worst possible pain"|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.|||units on a scale||95% Confidence Interval|Mean
1391860|NCT01338493|Primary|Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.|||units on a scale||95% Confidence Interval|Mean
1391861|NCT01338415|Other Pre-specified|Overall Survival|Overall survival was defined as the time elapsed between the first study drug administration and death (any cause) up to end of study (Month 18 survival follow-up), regardless of whether the patient was on study treatment. Patients who died, regardless of the cause of death, were considered to have had an event.Patients last known to have been alive were censored on their date of last contact. Percentage of participants without death at different time points was estimated using Kaplan-Meier methodology.|From baseline to month 18|These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study|||Percentage of participants||95% Confidence Interval|Number
1391862|NCT01338415|Other Pre-specified|Pulmonary Arterial Hypertension (PAH) Progression up to End of Treatment + 7 Days|PAH progression was defined by time elapsed from the first study drug administration in the FUTURE core study to the day of the first occurrence of any of the following PAH worsening events: death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH or new / worsening right heart failure. Subjects without a PAH worsening event were censored at EOT + 7 days. PAH progression was estimated by Kaplan-Meier methodology and expressed by the percentage of participants free of events at different time points.|From baseline to Month 18|These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study|||Percentage of patients free of events||95% Confidence Interval|Number
1391863|NCT01338415|Other Pre-specified|Number of Patients With Pulmonary Arterial Hypertension (PAH) Worsening Components up to the Last Day of Treatment + 7 Days|Number of patients with at least one PAH-worsening component (death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH, new/worsening right heart failure) reported cumulatively over FUTURE 3 core and extension study.|Up to 62 weeks in average|The intent to treat population was used|||Participants|||Count of Participants
1391864|NCT01338415|Other Pre-specified|Change From Baseline up to 18 Months of Study Treatment in the Global Clinical Impression Scale (GCIS)|The GCIS is a scale used to rate the patient’s current overall clinical condition (“Very Good”, “Good”, “Neither Good or Bad”, “Bad”, and “Very Bad”). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.|At Month 18|The intent to treat population was used. No imputation method was used. Only patients with available results at the corresponding time point are including in the analysis.|||Participants|||Count of Participants
1391865|NCT01338415|Other Pre-specified|Change From Baseline up to 12 Months of Study Treatment in the Global Clinical Impression Scale (GCIS)|The GCIS is a scale used to rate the patient’s current overall clinical condition (“Very Good”, “Good”, “Neither Good or Bad”, “Bad”, and “Very Bad”). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.|At Month 12|The intent to treat population was used for these analyses. No imputation method was used. Only patients with available results at the corresponding time point are included in the analysis.|||Participants|||Count of Participants
1391866|NCT01338415|Other Pre-specified|Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC)|The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement ( change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.|At Month 18|The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score.|||Participants|||Count of Participants
1392771|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death|Prospective comparison of time to first occurrence of Individual component of primary endpoint: cardiovascular death|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
1391867|NCT01338415|Other Pre-specified|Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC)|The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement ( change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.|At Month 12|The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score.|||Participants|||Count of Participants
1391868|NCT01338415|Primary|Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation|"This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study.~NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here."|Up to 62 weeks in average|The analysis was performed on the Safety population analysis set, including all patients who received at least one dose of study treatment and evaluated according to the study treatment that they received.|||Participants|||Count of Participants
1391869|NCT01338298|Secondary|To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.|We will measure if patients' symptoms improve, improvement in their sexual dysfunction or distress and if they feel better with the elimination of the side effects. We hypothesize that aripiprazole will improve psychiatric symptoms, quality of life, sexual functioning and perceived wellness relative to placebo in women stabilized on risperidone (or paliperidone).|16 Weeks|14 of the 20 participants receiving Aripiprazole and 11 of the 18 participants receiving placebo reported sexual dysfunction at baseline.|||Participants|||Count of Participants
1391870|NCT01338298|Primary|To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).|We will assess this outcome by monitoring the return of menstruation and the elimination of lactation. We hypothesize that adjunct aripiprazole will resolve hormonal effects in women with symptomatic hyperprolactinemia stabilized on risperidone (or paliperidone).|16 Weeks|13 of the 20 Aripiprazole participants had lack of menstruation a the start of the study, and 11 of the 18 participants receiving placebo had lack of menstruation a the start of the study, therefore the analysis of return of menstruation is based on 24 participants.|||Participants|||Count of Participants
1391871|NCT01338025|Secondary|Number of Participants Non-adherent as Measured by 3-day Recall|Number of participants reporting a missed medication dose in the past 3 days.|28 Weeks|All eligible participants with adherence data available at week 28.|||participants|||Number
1391872|NCT01338025|Secondary|Change in HIV-1 RNA Levels|Change in HIV-1 RNA levels from Entry to Week 28|28 Weeks|All eligible participants with HIV-1 RNA results available at entry and at week 28.|||copies/mL||Inter-Quartile Range|Median
1391873|NCT01338025|Secondary|Change in CD4+ T Cell Count|Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).|Entry to week 28|All eligible participants with CD4+ cell count results available at entry and at week 28.|||CD4+ T cell count/mL||Inter-Quartile Range|Median
1391874|NCT01338025|Primary|Number of Participants With Immunologic Deterioration|"Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:~greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or~development of CDC class C events.~Results report number of participants with immunologic deterioration at week 28 calculated."|From entry to week 28|All eligible participants who entered the study were included in analyses. One participant on Arm A did not meet entry eligibility criteria; was taken off study after the entry visit, and is therefore excluded from all analyses.|||participants|||Number
1391875|NCT01338012|Primary|Number of Study Participants Enrolled and Treated Prior to Study Termination|Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.|Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015|This study was terminated early due to administrative reasons. Only eight subjects out of the ninety subjects planned were enrolled and treated. Given the small number of patients enrolled, results should be interpreted with caution.|||Participants|||Count of Participants
1391876|NCT01337960|Secondary|Anticipatory Postural Adjustments|During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|These data were not collected due to technical issues.||||||
1391877|NCT01337960|Secondary|Dynamic Gait Index|The Dynamic Gait Index (DGI) assesses individual’s ability to modify balance while walking in the presence of external demands. Performed with a marked distance of 20 feet . The DGI can be performed with or without an assistive device. Scores are based on a 4-point scale: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; 0 = Severe impairment. The highest possible score is 24 points. asks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; Stair climbing.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||units on a scale||Standard Error|Mean
1391878|NCT01337960|Secondary|Berg Balance Scale|14-item scale to assess balance function and fall risk, 56 is top score possible (0-56); higher scores indicate higher balance function. Items assess static and dynamic activities of varying difficulty; they are performed to evaluate global level of balance function. Item-level scores range from 0-4, determined by ability to perform the assessed activity; item scores are summed to create the overall score. Subscales are not analyzed.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||units on a scale||Standard Error|Mean
1391879|NCT01337960|Secondary|Gait Kinetics|Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||Newton-seconds||Standard Error|Mean
1391880|NCT01337960|Primary|Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention|Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||cm/sec||Standard Error|Mean
1391881|NCT01337739|Secondary|Time to Discharge|Time to discharge from the Post Anesthesia Care Unit or home or to hospital room.|24 Hours||||minutes||Standard Deviation|Mean
1391882|NCT01337739|Primary|The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.|The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.|Interoperative period||||Total Morphine Equivalents mg||Standard Deviation|Mean
1391883|NCT01337674|Secondary|Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618|Blood samples were collected on Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose for the determination of plasma MK-4618 concentration. The hypothesis for this outcome is that the steady-state AUC0-24hr for MK-4618 is >=0.47 uM*hr.|Predose and up to 24 hours postdose on Day 7|The Per Protocol population included participants who complied with the protocol sufficiently to ensure that the data will likely exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||90% Confidence Interval|Geometric Mean
1391884|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.|||mmHg||95% Confidence Interval|Mean
1391885|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.|||mmHg||95% Confidence Interval|Mean
1391886|NCT01337674|Primary|Percentage of Participants With a Clinical or Laboratory Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded.|Up to 42 days|The All Subjects as Treated population included all participants who received >=1 dose of study drug|||Percentage of participants|||Number
1391887|NCT01337635|Secondary|Time to Restart Topical Steroids|The time to restart topical steroids and the SCORAD score at time of restart will be secondary study endpoints.|2 years|||||||
1391888|NCT01337635|Primary|Atopic Dermatitis Severity at the Completion of Treatment|The SCORAD (Severity Scoring of Atopic Dermatitis) is a clinical measurement tool assessing the severity of atopic dermatitis. The range of SCORAD measurements is 0 (best possible outcome) - 103 (worst possible outcome). The primary study endpoint will be the SCORAD score at the end of the 6 week treatment period.|6 weeks||||units on a scale||Full Range|Mean
1391889|NCT01337609|Secondary|Patient Global Impression of Change (PGI-C) - IBS Symptoms|The PGI-C is a self-administered measure of the degree of improvement in IBS symptoms compared to the first study visit. Degree of improvement in IBS symptoms from first to final visit will be assessed using this scale.|Administered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
1391890|NCT01337609|Secondary|Adequate Relief of IBS Pain (AR-IBS)|The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.|Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
1391891|NCT01337609|Secondary|Visual Analog Scale (VAS)|The VAS is a self-administered measure of abdominal pain, discomfort, and bloating. The change in total score from baseline to study endpoint will be assessed.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
1391892|NCT01337609|Secondary|IBS Severity Scoring System (IBS-SSS)|The IBS-SSS is a validated instrument used to assess common IBS symptoms over the past 10 days including abdominal pain, distention, bowel habit, and global function. The IBS-SSS will be used to assess the absolute change in specific IBS symptoms at endpoint, namely the bloating/distension score.|Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
1392086|NCT01336023|Secondary|Mean Change From Baseline in Body Weight at Week 26|Values of mean change in body weight.|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial; hence 1 subject from each arm was excluded from the FAS.|||kg||Standard Deviation|Mean
1391893|NCT01337609|Primary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)is a self report measure that addresses depressive symptoms. MDD responders will be defined as those exhibiting a 50% decrease in the QIDS SR at study endpoint.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
1391894|NCT01337336|Secondary|Number of the Indicated COPD-related Exacerbations|The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).|||number of exacerbations||Standard Deviation|Mean
1391895|NCT01337336|Secondary|Mean Annual COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).|||United States (US) dollars||Standard Deviation|Mean
1391896|NCT01337336|Secondary|Number of Participants With the Indicated COPD-related Exacerbations|The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintanance medication for COPD (index date).|||participants|||Number
1391897|NCT01337336|Primary|Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation|The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).|||participants|||Number
1391898|NCT01337297|Secondary|State of Depression|It will be applied Hamilton Scale for Depression, a structured multiple choice questionnaire used to assess the severity of the symptoms of depression. It will be applied with cognitive tests.|Before the first experimental session, in the middle of the treatment and after the last experimental session.|||||||
1391899|NCT01337297|Secondary|Cognitive Tests|Cognitive tests are comprised by frontal assessment battery (FAB), Mini-Mental Status Examination (MMSE), verbal n-back task, visuospatial n-back task, go/no-go test.|Before the first experimental session, in the middle of the protocol and two days after the last experimental session|||||||
1391900|NCT01337297|Secondary|Event Related Potentials|Event Related Potentials (ERPs) elicited by random presentation of three related images and three non-related images to crack use every Monday and Friday over the two-weeks period of active-tDCS or sham-tDCS.|twice a week over two consecutive weeks during the treatment|||||||
1391901|NCT01337297|Secondary|Intensity of the Urge to the Use of Crack-cocaine|The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.|before and after ERP in two weekly sessions over two weeks|||||||
1391902|NCT01337297|Primary|Abstinence|abstinence to the use of crack-cocaine up to 3 months after the completion of two-weeks of treatment sessions with active-tDCS or sham-tDCS.|Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.||||percentage of participants|||Number
1391903|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 181 days after any infant vaccination (up to 12 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
1391904|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 15 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
1392208|NCT01335685|Secondary|Maximum Inhibition Rate (Emax) (Phase 1)|Whole blood 20S proteasome inhibition parameters|At multiple time points during Cycles 1-3 of each phase and arm of the study, throughout approximately 84-126 days depending on the arm of the study|Due to the change in the planned analysis, the efficacy endpoint of maximum inhibition rate was not performed.||||||
1391905|NCT01337167|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.|||Percentage of participants|||Number
1391906|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after each infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
1391907|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
1391908|NCT01337167|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
1391909|NCT01337167|Secondary|Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||units/mL||95% Confidence Interval|Geometric Mean
1391910|NCT01337167|Secondary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||μg/mL||95% Confidence Interval|Geometric Mean
1391911|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391912|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391913|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391914|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
1391915|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391939|NCT01337089|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)|The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers “extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied”. Last visit refers to the last visit that a participant completed the assessment.|Last Visit (up to Day 183)|The Safety Population included all participants receiving at least 1 dose of study drug.|||Participants|||Count of Participants
1391916|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391917|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391918|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
1391919|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391920|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391921|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391922|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
1391923|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391924|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391925|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391926|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1392018|NCT01336621|Secondary|Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621.|Baseline and up to 5.8 years|Safety Population|||Participants|||Number
1391927|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391928|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391929|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391930|NCT01337167|Primary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391931|NCT01337167|Primary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 International unit (IU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391932|NCT01337167|Primary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 milli International units (mIU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391933|NCT01337167|Primary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer >=0.15 μg/mL and >=1.0 μg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
1391934|NCT01337115|Primary|VAS Results - Pain Scores Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 24h after surgery .~VAS scale:~0 - no pain 100 - worst possible pain"|24h after surgery|In the CFNB group 2 patients did not complete the protocol. Analysis was made in an ITT manner and Last Observational Carried Forward (LOCF) was the imputation technique used. In the SNB group, all 25 patients completed the protocol|||units on a scale||Standard Deviation|Mean
1391935|NCT01337115|Primary|VAS Results - Pain Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 12h after surgery .~VAS scale:~0 - no pain 100 - worst possible pain"|12h after surgery|All 25 patients in each arm completed the protocol. Analysis was made in an ITT manner.|||units on a scale||Standard Deviation|Mean
1391936|NCT01337115|Secondary|Satisfaction With Anesthesia Technique in Each Arm of the Study|"Satisfaction with the anesthesia technique using a categorical scale with three levels:~Bad Reasonable Good/Very Good A Fisher's Exact test is made to asses any differences in the distribution of patients in each arm to each level of the categorical scale"|1 month after surgery|Analysis was performed on Participants available for telephone contact one month after surgery and was made per protocol.|||participants|||Number
1391937|NCT01337115|Primary|Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)|Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain|15-30 min after arrival on post anesthesia care unit (PACU)|Participants were analyzed in an Intention to treat (ITT) manner. All randomized subjects (25 in each arm) completed the protocol so all were included for analysis as planned.|||units on a scale||Standard Deviation|Mean
1391938|NCT01337089|Secondary|Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was “no constipation”, and 10 was “constipation as bad as you can imagine.” Last visit refers to the last visit that a participant completed the assessment.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.~A negative value indicates improvement in condition from Baseline."|Baseline, Last Visit (up to Day 183)|The Safety Population included all participants receiving at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1391940|NCT01337089|Secondary|Change From Baseline In Mean Sleep Disruption NRS During The Last Period|"Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated “did not disrupt sleep” and a score of 10 indicated “completely disrupted (unable to sleep at all).” Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score.~A negative value indicates an improvement in sleep disruption score from Baseline."|Baseline, Last Period (Days 156-183) or last 27 days of treatment|The Safety Population included all participants receiving at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1391941|NCT01337089|Secondary|Change From Baseline In Mean NRS Average Pain During The Last Period|"Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated “no pain” and a score of 10 indicated “pain as bad as you can imagine.” Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score.~A negative value indicates an improvement in average pain score from Baseline."|Baseline, Last Period (Days 156-183) or last 27 days of treatment|The Safety Population included all participants receiving at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1391942|NCT01337089|Primary|Percent Of Participants With Treatment-emergent Adverse Events|Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.|Baseline, Day 183|The Safety Population included all participants receiving at least 1 dose of study drug.|||percent of participants|||Number
1391943|NCT01337076|Primary|CNC Monosyllabic Word Score - Treated Ear|"The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements.~CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet."|Six months||||percent correct||Full Range|Mean
1391944|NCT01337050|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization or the first dose date plus 1) divided by 30.44). PFS was calculated using the median, and 95% Confidence Intervals (CIs) and Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||months||95% Confidence Interval|Median
1391945|NCT01337050|Secondary|Number of Participants With Clinical Benefit Response (CBR)|Number of participant with clinical benefit response (CBR): CBR was defined as CR, PR, SD >12 weeks, SD<12weeks or PD according to RECIST criteria; Complete response (CR): disappearance of all lesions, Pathological lymph nodes’ reduction in short axis (SA) to <10 mm; Partial response (PR): >=30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1391946|NCT01337050|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST); Complete response (CR): disappearance of all lesions, Pathological lymph nodes’ reduction in short axis (SA) to less than (<)10 millimeter (mm); Partial response (PR): greater than equal to (>=) 30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start. Confirmed response=that persist at least 4 weeks after initial documentation.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1391947|NCT01337050|Secondary|Number of Participants With Human Anti-Human Antibody (HAHA)|HAHA analysis was performed using validated, sensitive and specific chemiluminescence enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline, Post-dose (Day 1 of every Cycle up to 28 days after last dose) up to Cycle 30|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1392052|NCT01336621|Primary|Number of Participants With Abnormal Discoloration of Skin|Number of participants with Dermatologist-Confirmed abnormal discoloration of skin including skin around the eyes and eyelids, lips, nails, or mucosa were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.|Up to 5.8 years|Safety Population. Only those participants who had at least one skin exam by the investigator or dermatologist on or before the last dose of RTG or dermatologist-confirmed discoloration with start date on or before the date of last dose of RTG are presented.|||Participants|||Number
1391948|NCT01337050|Secondary|Soluble Proteins Level|Soluble proteins related to Activin Receptor-Like Kinase 1 (ALK-1) signaling and angiogenesis signaling including Vascular adhesion molecule (VAM), Monocyte chemotactic protein 1 (MCP-1), Angiopoietin 2, Tear intercellular adhesive molecule 1 (ICAM-1), Soluble intracellular adhesion molecule 1 (SIAM-1), Soluble vascular adhesion molecule 1 (SVAM-1), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Soluble vascular endothelial growth factor- Receptor 1 (REC 1) (SVEGF-REC 1), Soluble vascular endothelial growth factor- REC 2 (SVEGF-REC 2), Soluble vascular endothelial growth factor- REC 3 (SVEGF-REC 3), Bone morphogenetic protein-9 (BMP-9), Endoglin, Transforming growth factor- beta 1 (TGF- Beta 1), Placental growth factor (PGF) was evaluated.|Baseline, Day 1, 0 hour (H), 6 H Cycle 1 Day 1, Day 22 of Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3 and end of treatment (up to cycle 30)|Biomarker analysis population included all enrolled and treated participants with baseline and on-treatment biomarker sample analyzed. Here “n”= participants who were evaluable for specified biomarker at given time point for each arm, respectively.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
1391949|NCT01337050|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||days||Standard Deviation|Mean
1391950|NCT01337050|Secondary|Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
1391951|NCT01337050|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1391952|NCT01337050|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) for drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1391953|NCT01337050|Secondary|Area Under the Curve From Time Zero to 28 Days [AUC (0-28)]|AUC (0-28)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28).|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1391954|NCT01337050|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.|||hours (hr)||Full Range|Median
1391955|NCT01337050|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1391956|NCT01337050|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|Pharmacokinetic (PK) parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1391957|NCT01337050|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormalities were segregated into hematology, chemistry, coagulation and urinalysis test. It had been graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) into Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life-threatening). Participants with abnormality of any of these grades are reported.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1391958|NCT01337050|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (non-SAEs). Relatedness to study drug was assessed based on investigator's discretion.|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1391959|NCT01337050|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 1 (Mild Adverse Event), Grade 2 (Moderate Adverse Event), Grade 3 (Severe Adverse Event), Grade 4 (Life- Threatening or Disabling Adverse Event), Grade 5 (Death Related to Adverse Event).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1391960|NCT01337050|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious adverse events (non-SAEs).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1391961|NCT01337050|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.|Baseline up to 28 days after last dose of study medication|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg/kg|||Number
1391962|NCT01337050|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than [< ])500/cubic millimeter [mm^ 3]) lasting for greater than equal to (>=) 8 days; Febrile Neutropenia >= Grade 3; Neutropenic Infection >= Grade 3; Grade 4 thrombocytopenia (<25,000/mm^3); Grade 3 thrombocytopenia (<50,000/mm^3) with active bleeding; Grade 3 or higher non-hematological toxicity.|Baseline up to Week 6|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||mg/kg|||Number
1391963|NCT01336972|Secondary|Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.|The volume of urine from each 2-hour urine collection in the renal function tests at Baseline, Final Treatment, and Post Treatment was recorded. Individual voids in a collection interval were pooled before determination of total volume.|2 hours|All participants who took any trial medication and had a postbaseline renal function test.|||mL||Standard Deviation|Mean
1391964|NCT01336972|Secondary|Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.|A 24-hour split urine sample (approximate times: 0700 to 1700 hours, 1700 hours to bedtime, and bedtime to 0700 hours) was collected beginning the day before the Baseline, Final Treatment, and Post Treatment visits and ending at admission to the renal function ward. Individual voids in a collection interval were pooled and the total volume determined.|24 hours|All participants who took any trial medication and had a postbaseline renal function test.|||mL||Standard Deviation|Mean
1391965|NCT01336972|Secondary|Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|TKV was measured using magnetic resonance imaging.|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||Percent||Standard Deviation|Mean
1391966|NCT01336972|Secondary|Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.~At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.~At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.|||ng.h/mL||Standard Deviation|Mean
1391967|NCT01336972|Secondary|Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.~At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.~At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.|||hours||Full Range|Median
1391968|NCT01336972|Secondary|Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.~At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.~At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.|||ng/mL||Standard Deviation|Mean
1392053|NCT01336621|Primary|Number of Participants With Pigmentation of Non-retinal Ocular Tissue(s)|Number of participants with abnormal findings after eye examination were evaluated. Pigmentation of non-retinal ocular tissue (s) detected on-treatment with retigabine were presented. Non-retinal pigmentary abnormalities included abnormalities in the sclera and/ or conjunctiva, cornea, iris and lens.|Up to 5.8 years|Safety Population. Only those participants with >=1 ophthalmology exam on or before last dose of RTG are presented.|||Participants|||Number
1391969|NCT01336972|Secondary|Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||mL/min||Standard Deviation|Mean
1391970|NCT01336972|Primary|Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||Ratios||Standard Deviation|Mean
1391971|NCT01336972|Primary|Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||mL/min||Standard Deviation|Mean
1391972|NCT01336972|Primary|Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). The mGFR was corrected for voiding errors.|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||mL/min||Standard Deviation|Mean
1391973|NCT01336933|Secondary|Percent of Patients Who Proceeded With Transplant|Percentage of patients who received consolidation with high dose therapy and autologous stem cell rescue (HDT/SCR).|168-252 days (4 courses up to 6 courses of treatment)|Thirty-three patients were analyzed. One patient withdrew consent before starting therapy.|||Participants|||Count of Participants
1391974|NCT01336933|Secondary|To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events|Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly.|22 months|All eligible patients who received at least one cycle of chemotherapy were evaluable for toxicity.|||percentage of participants|||Number
1391975|NCT01336933|Secondary|Overall Survival (OS)|Estimated 2-year Overall Survival (OS), as well as plots of OS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for OS. Overall survival is defined as time from the first chemotherapy administered on trial until death from any cause.|2 years|All evaluable patients irrespective of the total number of cycles of therapy received were included in EFS and OS analyses.|||percentage of participants analyzed||95% Confidence Interval|Number
1391976|NCT01336933|Secondary|Event Free Survival (EFS)|Estimated 2-year Event Free Survival (EFS), as well as plots of EFS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for EFS. Event-free survival is defined as time from therapy until relapse, progression, or death from any cause.|2 years|All evaluable patients irrespective of the total number of cycles of therapy received were included in the EFS and OS analyses.|||percentage of participants analyzed||95% Confidence Interval|Number
1391977|NCT01336933|Secondary|Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))|"Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals.~Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: > 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT Spleen, Liver:> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified"|2 years||||percentage of participants analyzed|||Number
1391978|NCT01336933|Primary|Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment|"Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4–6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator’s preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used.~Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) [18F]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative"|168 days - 252 days (4-6 courses; 42 days per course)||||percentage of participants analyzed|||Number
1391979|NCT01336894|Secondary|Pulmonary Function Test Values|Pulmonary function test values include forced expiratory volume 1 (FEV1), carbon monoxide diffusion (DLCO) and forced vital capacity (FVC).|Up to 12 months post-therapy|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
1391980|NCT01336894|Secondary|Disease-free Survival|Disease free survival is defined as the time from randomization until documented disease recurrence or death, whichever occurs first. Patient who are disease free and alive at the time of analysis will be censored at the time of their last follow up.|Up to 5 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
1391981|NCT01336894|Secondary|Adverse Event Profiles at 12 Months Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.~Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|12 months post-therapy|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
1391982|NCT01336894|Secondary|Adverse Event Profiles at 3 Months Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.~Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|3 months post-therapy|All enrolled participants who received protocol interventions and had adverse event reported at months 3 post-therapy.|||Participants|||Count of Participants
1391983|NCT01336894|Secondary|Adverse Event Profiles at 1 Month Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.~Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|1 month post-therapy|All enrolled participants who received protocol interventions and had adverse events reported at 1 month post-therapy.|||Participants|||Count of Participants
1391984|NCT01336894|Secondary|Loco-regional Recurrence-free Survival|Loco-regional recurrence is defined as recurrence within the same lobe or hilum (N1 nodes), or within 2 cm of the staple line or within 2 cm of the PTV after treatment effects such as scarring have subsided.|Up to 5 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
1391985|NCT01336894|Primary|3-year Overall Survival (OS) Rate|Overall survival is defined as the time from randomization until death from any cause.|Up to 3 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
1391986|NCT01336764|Primary|Reduced Heart Rate During Driving (Aggregated Over Sessions)|averaged over sessions|during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart||||beats per minute||Standard Deviation|Mean
1391987|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
1391988|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
1391989|NCT01336738|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||kilogram (kg)||Standard Deviation|Mean
1391990|NCT01336738|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
1392159|NCT01335932|Secondary|SF-36 Health Survey|Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.|at 1 day post-randomization||||scores on a scale||Standard Deviation|Mean
1391991|NCT01336738|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
1391992|NCT01336738|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1391993|NCT01336738|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
1391994|NCT01336712|Secondary|Cumulative Incidence of Chronic Graft-versus-host Disease||2 year||||percentage of patients analyzed|||Number
1391995|NCT01336712|Secondary|Relapse Rate||2 year||||percentage of patients analyzed|||Number
1391996|NCT01336712|Secondary|Non-relapsed Mortality (NRM) Percentage||2 year||||percentage of patients|||Number
1391997|NCT01336712|Secondary|Disease Free Survival (DFS) Percentage||2 year||||percentage of patients analyzed|||Number
1391998|NCT01336712|Secondary|Percentage of Participatns With Donor Chimerism Post-transplant|Characterize donor hematopoietic chimerism in peripheral blood at day 30 after HSCT.|Day 30||||percentage of patients|||Number
1391999|NCT01336712|Secondary|Survival|To obtain estimate of overall survival (OS)|2 year||||percentage of patients analyzed|||Number
1392000|NCT01336712|Primary|Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant|1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.|6 months||||percentage of patients|||Number
1392001|NCT01336647|Secondary|Safety and Tolerability of Ha44 Gel|The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.|From treatment to last visit of the study at 14 days|All subjects who participated|||participants with treatment related AEs|||Number
1392002|NCT01336647|Primary|Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit||Follow up visit at days 1, 7 and 14 days|Intent to Treat|||participants|||Number
1392003|NCT01336634|Secondary|Volume of Distribution (V/F) of Dabrafenib and Trametinib|Blood samples from participants were collected for population pharmacokinetic analysis including V/F following oral dosing of dabrafenib and trametinib.|Week 3, Week 6, Week 12 and Week 18|PK Set|||Liter||95% Confidence Interval|Mean
1392004|NCT01336634|Secondary|Apparent Clearance (CL/F) of Dabrafenib and Trametinib|Blood samples from participants were collected for population pharmacokinetic analysis including CL/F following oral dosing of dabrafenib and trametinib.|Week 3, Week 6, Week 12 and Week 18|PK Set|||Liter/hour||95% Confidence Interval|Mean
1392005|NCT01336634|Secondary|Number of Participants With AEs and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.|Up to Week 12 and then every 3 weeks up to follow up, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
1392006|NCT01336634|Secondary|Number of Participants With Abnormal Hematology Values|Blood samples were collected from participants for evaluation of hematology parameters by worst case post-Baseline increase. The hematology parameters included leukocytes, neutrophils, platelets and high and low hemoglobin and lymphocytes. Participants were counted in the category that their values shows any grade increase , Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Up to Week 12 and then every 3 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh-C|||Participants|||Number
1392007|NCT01336634|Secondary|Number of Participants With Abnormal Clinical Chemistry Values|Blood samples were collected from participants for evaluation of clinical chemistry parameters by worst case post-Baseline increase. The clinical chemistry parameters included creatinine, phosphate and high and low calcium, glucose, magnesium, potassium and sodium. Participants were counted in the category that their values shows any grade increase , Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Up to Week 12 and then every 3 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh-C|||Participants|||Number
1392008|NCT01336634|Secondary|Number of Participants With Abnormal Echocardiogram Findings|Echocardiography scans were obtained at given time points using an echocardiogram and the findings for left ventricular ejection fraction (LVEF) were obtained. LVEF values at worst case post-Baseline were recorded as any increase and any decrease values.|Week 6, Week 15 and then every 9 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
1392160|NCT01335932|Secondary|Grade 3 AEs or Higher|Number of patients with greater than one AE of grade 3 or more|by 35 days post-randomization||||Participants|||Count of Participants
1392009|NCT01336634|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Values|Single measurements of 12-lead ECGs were obtained at given time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) interval. ECG values at worst case post-Baseline were categorized as 'clinically significant change from Baseline' and 'not a clinically significant change'.|Week 3, Week 6, Week 15 and then every 9 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
1392010|NCT01336634|Secondary|Number of Participants With Abnormal Vital Signs Values|"Number of participants with abnormal values of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and temperature were evaluated. Participants with worst case post-Baseline vital sign values were presented at the given timepoints. Only those participants with data available at the specified data points were analyzed. All treated population was used for monotherapy cohort which comprised of all participants in the monotherapy cohort who receive at least one dose of study treatment. HR: <60 bpm clinical concern-low; >100 bpm Clinical concern-high Temperature: <=35 °C clinical concern - low; >=38 °C clinical concern – high For SBP change from baseline, the following categories will be used: Grade 0: <120 mm Hg; Grade 1: >=120-<140 mmHg; Grade 2: >=140-<160 mmHg; Grade 3: >=160 mmHg;~For DBP change from baseline, the following categories will be used:~Grade 0: <80 mm Hg; Grade 1: >=80-<90 mmHg; Grade 2: 90-<100 mmHg; Grade 3: >=100mmHg"|Up to Week 12 and then every 3 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
1392011|NCT01336634|Secondary|Overall Survival (OS) at the Date of Analysis|OS defined as the time from first dose until death due to any cause. CI estimated using the Brookmeyer Crowley method. A value of NA indicates where no data is available or not able to determine the value. The upper bound of the 95 percent CI for the median was not reached due to insufficient event rates for Arm 2 (58 percent) and Arm 3 (28 percent).|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Months||95% Confidence Interval|Median
1392012|NCT01336634|Secondary|Progression Free Survival (PFS) at the Date of Analysis|PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. The target and non-target lesions were identified at time of screening and the same lesions were re-assessed by a contrast-enhanced brain magnetic resonance imaging (MRI) or Computed tomography (CT) every 6 wks after initiation of study treatment until Week 36 and then every 12 wks. CI estimated using the Brookmeyer Crowley method. A value of NA indicates where no data is available or not able to determine the value for Arm 3 due to a low event rate in the population (36 percent).|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Months||95% Confidence Interval|Median
1392013|NCT01336634|Secondary|Duration of Response (DoR) at the Date of Analysis|DoR is defined for the subset of participants with confirmed CR or PR, as the time from first documented evidence of CR or PR until time of first documented disease progression or death due to any cause. The response was analyzed every 6 weeks after initiation of study treatment until Week 36 and then every 12 wks. Disease progression will be based on radiological assessments [magnetic resonance imaging (MRI) or computed tomography (CT)]. Confidence Intervals (CIs) estimated using the Brookmeyer Crowley method. Upper limit of confidence interval was not reached as data were not yet mature. A value of NA indicates where no data is available or not able to determine the value for Arm 3 due to a low event rate in that population (27 percent).|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Months||95% Confidence Interval|Median
1392014|NCT01336634|Primary|Percentage of Participants With Overall Response Rate (ORR) at the Date of Analysis|ORR is defined as the percentage of par. with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria In Solid Tumors evaluates the response on the basis of target and non-target lesions, and best over all response. The response rate was analyzed every 6 weeks (wks) after initiation of study treatment until Week 36 and then every 12 wks until discharge or crossover. Percentage of par. analyzed as number of par. having overall response on the date of analysis from Baseline multiply by 100. The Second Line Plus All Treated Population used for cohort A and B consisted of all par. in the All Treated Population who had received at least one line of prior anti-cancer therapy for advanced/metastatic disease. The First-Line All Treated Population used for cohort C consisted of all par. in the All Treated Population who had not received any prior anti-cancer therapy for advanced/metastatic disease.|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Percentage of Participants||95% Confidence Interval|Number
1392015|NCT01336621|Secondary|Number of Participants Who Remained Seizure-free|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Number of participants who were treated retigabine for at least 6 months and who remained seizure free for any 6 continuous months as well as number of participants who were treated with retigabine for at least 12 months and who remained seizure free for any 12 continuous months are presented.|Up to 5.8 years|Safety population|||Participants|||Number
1392016|NCT01336621|Secondary|Number of Participants Experiencing an Increase in 28-day Partial-onset Seizure Frequency From Baseline|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621.|Baseline and up to 5.8 years|Safety Population|||Participants|||Number
1392017|NCT01336621|Secondary|Percent Change From Baseline in 28-day Partial-onset Seizure Frequency|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Percent change from Baseline in 28-day partial onset seizure frequency was presented as mean and standard deviation (SD). Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Percent change from Baseline was calculated as post-Baseline value minus Baseline value divided by Baseline value into 100.|Baseline and up to 5.8 years|Safety Population|||Percent change||Standard Deviation|Mean
1392019|NCT01336621|Primary|Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration|Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.|Up to 2.6 years|All SFUCP Subjects|||Days||Full Range|Median
1392020|NCT01336621|Primary|Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation|Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included abnormality of macula, peripheral retina and unspecified location. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than one location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved.|Up to 2.6 years|All SFUCP Subjects|||Days||Full Range|Median
1392021|NCT01336621|Primary|Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine|Participants who enter the SFUCP who had an on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist entered the SFUCP and underwent assessments performed by a dermatologist at 6-monthly intervals. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.|Up to 2.6 years|All SFUCP Subjects|||Participants|||Number
1392022|NCT01336621|Primary|Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine|The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.|Up to 2.6 years|All SFUCP Subjects|||Participants|||Number
1392023|NCT01336621|Primary|Duration of Retigabine Exposure|Duration of exposure was calculated from the first dose through the last dose during study including the Taper Phase and presented using median and full range.|Up to 5.8 years|Safety Population|||Weeks||Full Range|Median
1392024|NCT01336621|Primary|Number of Participants Experiencing Worsening of Seizures|Worsening of seizures was defined as an increase in seizure frequency or the occurrence of a new, more severe seizure type, or status epilepticus occurring in a participant without a history of status epilepticus. An increase in seizure frequency was defined as doubling of the 28-day seizure frequency compared to the 28-day Baseline seizure frequency established in the parent study. Number of participants experiencing worsening of seizure during study period are presented.|Up to 5.8 years|Safety Population|||Participants|||Number
1392025|NCT01336621|Primary|Number of Participants Experiencing New Seizure Types|Number of participants experiencing new seizure type that is seizure not experienced before were summarized. New seizure types were classified into 5 classes including type A (simple partial seizure), type B (complex partial seizure), type C (Partials, evolving to Secondary Generalized Seizures), type D (Generalized, excluding Myoclonic Seizures), type D2 (Myoclonic Seizures) and type E (Unclassified Seizures).|Up to 5.8 years|Safety Population|||Participants|||Number
1392026|NCT01336621|Primary|Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score|Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. Participants are classified with respect to extent of suicidal ideation, extent of suicidal behavior, and with respect to self-injurious behavior.|Up to 5.8 years|Safety Population|||Participants|||Number
1392027|NCT01336621|Primary|Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume|The PVR bladder ultrasound was used to assess urinary retention. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Milliliter (mL)||Standard Deviation|Mean
1392028|NCT01336621|Primary|Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score|The effect of retigabine on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale ranging from 0 (no symptom at all) to 5 (almost always symptoms present) with a total possible score of 35. AUA SS score is the sum of the responses to these seven questions. The total score for all questions was classified as mild (0 to 7), moderate (8 to 19), or severe (>19). Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Score on AUA SS scale||Standard Deviation|Mean
1392029|NCT01336621|Primary|Change From Baseline in Urine Creatinine Levels|Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including creatinine levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||µmol/L||Standard Deviation|Mean
1392030|NCT01336621|Primary|Change From Baseline in Urine Albumin Levels|Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Milligrams per liter (mg/L)||Standard Deviation|Mean
1392161|NCT01335932|Secondary|CMV Disease|Need to be biopsy-proven|by 180 days post-randomization||||Participants|||Count of Participants
1392031|NCT01336621|Primary|Change From Baseline in Urine Albumin Creatinine Ratio|Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Mg of urine albumin/ mmol of creatinine||Standard Deviation|Mean
1392032|NCT01336621|Primary|Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including percent basophils, eosinophils, lymphocytes, monocytes, neutrophils and RDW. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Percent of blood components||Standard Deviation|Mean
1392033|NCT01336621|Primary|Change From Baseline in RBC Count|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including RBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to 5.8 years|Safety Population|||Tetra cells per liter (TI/L)||Standard Deviation|Mean
1392034|NCT01336621|Primary|Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCV and MPV. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Femtoliter (fL)||Standard Deviation|Mean
1392035|NCT01336621|Primary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCH. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Picograms (Pg)||Standard Deviation|Mean
1392036|NCT01336621|Primary|Change From Baseline in Hematocrit Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hematocrit. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
1392037|NCT01336621|Primary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hemoglobin and MCHC. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||G/L||Standard Deviation|Mean
1392038|NCT01336621|Primary|Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including absolute basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and WBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Giga cells per liter (GI/L)||Standard Deviation|Mean
1392039|NCT01336621|Primary|Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including calcium, chloride, CO2, glucose, potassium, magnesium, sodium and BUN. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1392040|NCT01336621|Primary|Change From Baseline in BUN/Creatinine Ratio|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including BUN/creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Ratio of BUN to creatinine||Standard Deviation|Mean
1392041|NCT01336621|Primary|Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Micromole per liter (µmol/L)||Standard Deviation|Mean
1392042|NCT01336621|Primary|Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including alk. phosphatase, ALT, AST, creatine kinase and LD. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||International unit per liter (IU/L)||Standard Deviation|Mean
1392043|NCT01336621|Primary|Change From Baseline in Albumin and Total Protein|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including albumin and total protein. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Gram per liter (G/L)||Standard Deviation|Mean
1392044|NCT01336621|Primary|Number of Participants With Urinalysis Parameters of PCC|Urine samples were collected from participants at specific time points. Number of participants with urinalysis parameters of PCC at 'any visit post-Baseline' are presented. Urinalysis parameters for which PCC values were identified were albumin/creatinine ratio (if value is >11.3), red blood cells (RBC) (if value is 3-5 or higher), WBC (if value is 5-10 or higher for male and 10-15 or higher for females), specific gravity (if value is <1.001 or >1.035) and potential of hydrogen (pH) (if value is <4.6 or >8.0). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).|Up to 5.8 years|Safety Population|||Participants|||Number
1392045|NCT01336621|Primary|Number of Participants With Hematology Parameters of PCC|Blood samples were collected from participants to evaluate hematology parameters. Number of participants with clinical hematology parameters of PCC at 'any visit post-Baseline' are presented. Hematology parameters for which PCC values were identified were eosinophils (if value is >0.8), hematocrit (if value is <=0.32 for males and <=0.28 for females), platelet count (if value is <=100 or >=550), total neutrophils (if value is <=1.8), white blood cells (WBC) (if value is <=2.8 or >=16). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).|Up to 5.8 years|Safety Population|||Participants|||Number
1392046|NCT01336621|Primary|Number of Participants With Clinical Chemistry Parameters of PCC|Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented. Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >=3 * upper limit of normal [ULN]), alkaline phosphatase (alk.phosphatase) (if value >=3*ULN), aspartate aminotransferase (AST) (if value >=3*ULN), calcium (if value <=1.8962 or >=2.8692), carbon-di-oxide (CO2) (if value <=18 or >=36), chloride (if value <=92 or >=112), creatine kinase (if value >=3*ULN), direct bilirubin (if value >=1.5*ULN), glucose (if value <=2.7755 or >=11.102), lactate dehydrogenase (LD) (if value >=3*ULN), magnesium (if value <0.36 or >2.50), potassium (if value <=3.0 or >=6.0), sodium (if value <=127 or >=153), total bilirubin (if value >=1.5*ULN), total protein (if value <45 or >100), blood urea nitrogen (BUN) (if value >=14.28). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).|Up to 5.8 years|Safety Population|||Participants|||Number
1392047|NCT01336621|Primary|Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval|Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF and RR interval. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Milliseconds (msec)||Standard Deviation|Mean
1392048|NCT01336621|Primary|Change From Baseline in Electrocardiogram (ECG) Parameter Including HR|Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure HR. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
1392049|NCT01336621|Primary|Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight|Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured after at least 5 minutes of rest. Body weight was measured without shoes and wearing light clothing. Baseline assessments in this OLE study were defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Increase or decrease of >=20 in SBP, increase or decrease of >=15 in DBP and HR were considered as PCC values. Number of participants with PCC values of vital signs for any visit post-Baseline are presented.|Up to 5.8 years|Safety Population|||Participants|||Number
1392050|NCT01336621|Primary|Number of Participants With Decrease in Confrontational Visual Field From Initial Examination|Number of participants with a clinically significant decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.|Up to 5.8 years|Safety Population. Only those subjects with both initial and at least 1 follow-up exam while on RTG treatment are presented.|||Participants|||Number
1392051|NCT01336621|Primary|Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination|Number of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.|Up to 5.8 years|Safety Population. Only those participants with both initial and at least 1 follow-up exam while on RTG treatment are presented.|||Participants|||Number
1392162|NCT01335932|Secondary|Number of Days Alive and Not in the ICU|Number of ICU days alive and not in the ICU by day 28|by 28 days post-randomization||||days||Standard Deviation|Mean
1392054|NCT01336621|Primary|Number of Participants With Retinal Pigmentary Abnormalities|Number of participants with abnormal findings after eye examination were evaluated. Only retinal pigmentary abnormalities detected on-treatment with retigabine were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location.|Up to 5.8 years|Safety Population. Only those participants with >=1 ophthalmology exam on or before last dose of RTG are presented.|||Participants|||Number
1392055|NCT01336621|Primary|Number of Participants Withdrawn Due to TEAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolonged existing hospitalization, results in disability, is a congenital anomaly/birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose and on or before 30 days after the last retigabine dose date.|Up to 5.8 years|Safety Population|||Participants|||Number
1392056|NCT01336621|Primary|Number of Participants With AEs and SAEs: All SFUCP Subjects|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. The following AEs were collected in the SFUCP: AEs related to the finding(s) of pigmentation/, discoloration of the eye/skin, AEs related to unexplained vision loss, SAEs, Deaths and Pregnancies. SFUCP collected AEs are those for which onset was 31 days or more after the last dose of retigabine. The analysis was performed on the All SFUCP Subjects population which comprised of all subjects who enter the SFUCP.|Up to 2.6 years|All SFUCP subjects|||Participants|||Number
1392057|NCT01336621|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose in this study and on or before 30 days after the last retigabine dose date. AEs that started in the parent study that increased in severity during this study were also considered treatment-emergent. The analysis was performed on Safety Population, which included participants who took at least one dose of study medication after they had enrolled into this OLE study.|Up to 5.8 years|Safety Population|||Participants|||Number
1392058|NCT01336608|Secondary|Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 24 (Visit 6) each morning and prior to taking study medication (i.e., single-blind and double-blind study medication) supplemental medication (albuterol [salbutamol] if received) and ipratropium bromide (if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Analysis was performed using an analysis of covarience (ANCOVA) model with covariates of treatment, BL mean of occasions of rescue medication use (Week -1), history of exacerbation, and geographical region.|BL (Week -1), Week 1 to Week 24|ITT Population: all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.|||Occasions per 24 hours||Standard Error|Least Squares Mean
1392059|NCT01336608|Secondary|Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry at Screening, Days 1, 28, 84, 126, and 168. BL FEV1 was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 was defined as the mean of the FEV1 values obtained 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was preformed using a repeated measures model with covariates of visit, treatment, history of exacerbation strata, geographical region, BL FEV1 and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters (L)||Standard Error|Least Squares Mean
1392060|NCT01336608|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young’s modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||meters per second (m/sec)||Standard Error|Least Squares Mean
1392163|NCT01335932|Secondary|Number of Participants With Organ System Failure at 14 Days|Number of participants experiencing organ system failure at 14 days|at 14 days post-randomization||||Participants|||Count of Participants
1392061|NCT01336569|Primary|Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)|As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.|Baseline, up to 6 weeks|Intent-to-Treat (ITT): All participants who received study medication and had at least one on-therapy study visit.|||millimeters mercury (mmHg)||Standard Deviation|Mean
1392062|NCT01336413|Other Pre-specified|Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)|Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (QSM/STI) to assess possible myelin brain changes related to the intervention.|10 weeks||2018-02-28|02/2018||||
1392063|NCT01336413|Other Pre-specified|Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)|Diffusion Tensor Imaging (DTI) to assess possible white matter brain changes associated with intervention.|10 weeks||2018-02-28|02/2018||||
1392064|NCT01336413|Other Pre-specified|Functional Magnetic Resonance Imaging (Exploratory Neuroimaging Outcome)|Functional Magnetic Resonance Imaging (fMRI) to assess possible functional brain changes related to attention and emotion circuits associated with the intervention.|10 weeks||2018-02-28|02/2018||||
1392065|NCT01336413|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Total Score||Standard Error|Mean
1392066|NCT01336413|Secondary|CAPS Total Scores|Mean scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while and increase in CAPS score indicates an increase (worsening) in PTSD symptoms.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Total Score||Standard Error|Mean
1392067|NCT01336413|Secondary|BAC Composite|Composite z scores (allowing comparison from week 2 to week 10) to assess cognitive changes. The BAC includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. z scores are calculated from composite scores. Higher z scores are indicative of better cognitive performance, lower z scores are indicative of lower cognitive performance. Range of z scores anticipated to be between -3 and 3.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Composite z Score||Standard Error|Mean
1392068|NCT01336413|Secondary|Beck Depression Inventory-II (BDI-II)|21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scores range from 0 (no depression) to 63 (severe depression).|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Total Score||Standard Error|Mean
1392069|NCT01336413|Primary|Tower of London (Subscale Test of BAC) - PRIMARY COGNITIVE OUTCOME MEASURE|Subscale test asking subjects to determine the minimum number of moves that will be required to make convert one image of colored balls on pegs into a second different image. The test administers 20 items/images, with 2 additional items if all of the first 20 are answered correctly. Thus, scores range from 0-22, with lower scores representing greater impairment. Raw scores are converted to z scores that generally range from -3 to 3, with lower scores again representing greater impairment.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||z Score||Standard Error|Mean
1392070|NCT01336413|Primary|CAPS (Cluster D Symptoms) - PRIMARY BEHAVIORAL OUTCOME MEASURE|"The CAPS-IV criterion D is defined by persistent symptoms of increasing arousal (not present before the trauma), indicated by at least two of the following: difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hyper-vigilance, and exaggerated startle response There are two scales, frequency and intensity. Frequency scores range from 0 = none of the time to 4 = most or all of the time and intensity scores range from 0 = none to 4 = extreme. Severity scores are calculated from the sum of frequency and intensity scores. Five items are included in criterion D, thus the range of severity scores is 0-45. Higher scores are indicative of more symptoms."|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study|||Score||Standard Error|Mean
1392071|NCT01336296|Secondary|Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection||1 year||||participants|||Number
1392072|NCT01336296|Secondary|Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff ‘97|The Banff features suggestive of chronic rejection were: a) chronic transplant glomerulopathy: Glomerular basement membrane duplication and mesangial cell proliferation, and b) vasculopathy: Fibrous intimal thickening often with fragmentation of internal elastic lamina. Chronic changes in the interstitium (ci), tubules (ct), vessels (cv), and glomerulus (cg) were likewise graded into 0, 1, 2, and 3. The severity of interstitial fibrosis and tubular atrophy, as also chronic transplant glomerulopathy and vasculopathy were used to grade chronic allograft changes.|1 year||||participants|||Number
1392073|NCT01336296|Secondary|Difference in Renal Function|"Difference in renal function between groups at listed time points assessed by mean serum creatinine. Increased serum creatinine could indicate worsening renal function. A normal serum creatinine range for the transplant population varies by patient, but a typical range for Scr would be 1-2 mg/dL."|Difference at 1 month, 3 months, 6 months, 1 year||||mg/L||Standard Deviation|Mean
1392085|NCT01336023|Secondary|Number of Hypoglycaemic Episodes|Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.|Weeks 0-26|The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparators. The missing data was imputed using LOCF. The number of subjects analysed in SAS for each arm are 412, 825 and 412, respectively.|||Events per 100 patient years of exposure|||Number
1392164|NCT01335932|Secondary|BAL Levels of IL-6|Levels of IL-6 from BALs at 7 days post-randomization|at 7 days post-randomization|The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.|||log 10 pg/mL||Standard Deviation|Mean
1392074|NCT01336296|Secondary|Severity of Acute Rejection by Banff '97 Criteria|"Severity of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 1 year. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~As with humoral rejection, there are both acute & chronic forms:~The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).~Class IB: just like Class IA except there is more severe tubulitis.~Class IIA: there is mild-to-moderate intimal arteritis.~Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.~Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|Severity 1 year post transplant||||participants|||Number
1392075|NCT01336296|Primary|Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant|"Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~As with humoral rejection, there are both acute & chronic forms:~The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).~Class IB: just like Class IA except there is more severe tubulitis.~Class IIA: there is mild-to-moderate intimal arteritis.~Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.~Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|3, 6 and 12 months post transplant||||participants|||Number
1392076|NCT01336205|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.|||Participants|||Number
1392077|NCT01336205|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.|||Participants|||Number
1392078|NCT01336205|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.|||Participants|||Number
1392079|NCT01336140|Secondary|Patients With Recorded Aminophylline Related Major Adverse Events|Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure < 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.|Within 24 hours from the intervention.|All patients.|||participant|||Number
1392080|NCT01336140|Secondary|Global Symptom Score (GSS) of Regadenoson Related Adverse-effects|"GSS is the sum of severity-weighted (0 = none, 1 = mild, 2 = moderate, 3 = severe) regadenosnon-related adverse-effects of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.~GSS is calculated by weighting each side effect from 0 - 3 (as above) then add the severity weighted scores of all adverse effects (total of 10 as above).~The number of adverse effects contributing to the score is 10, each has a potential severity weight of 0 (absent) to 3 (severe). Thus:~Minimum possible Global Symptom Score (GSS) = 0 Maximum possible Global Symptom Score (GSS) = 30"|Within 2 hours from the intervention.|All patients.|||Global Symptom Score||Standard Deviation|Mean
1392081|NCT01336140|Secondary|Number of Patients With Any (One or More) Regadenoson-related Adverse-effect|"Regadenoson-related adverse-effects include: flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.~When multiple adverse effects are reported, only one event is counted."|Within 2 hours from the intervention.|All patients.|||Participants|||Number
1392082|NCT01336140|Primary|Diarrhea (as Reported by the Patient)|"Number of patients who report any incident of diarrhea. Patients will be surveyed for incidents of diarrhea following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory (typically within 2 hours from stress completion).~The primary endpoint encompasses the number of patients with reported symptoms of diarrhea, not the number of bowel movements."|Within 2 hours from the intervention|All patients.|||participants|||Number
1392083|NCT01336023|Secondary|Mean Actual Daily Insulin Dose|Mean of the actual doses recorded at visit 28 (Week 26).|Week 26|The FAS included all randomised subjects. Missing data was imputed using LOCF. For 22 subjects, the dose values were missing hence did not contribute to the analysis. The comparison was made between the insulin products IDeg and IDeglira.|||units||Standard Deviation|Mean
1392084|NCT01336023|Secondary|Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test|Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.|Week 0, Week 26|The number of subjects analysed were equal to study population in which the meal test was perfomed at selected sites. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
1392087|NCT01336023|Primary|Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.|Values of mean change in HbA1c.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial; hence 1 subject from each arm was excluded from the FAS.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
1392088|NCT01335997|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.||||||
1392089|NCT01335997|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.||||||
1392090|NCT01335971|Secondary|Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)|Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.|||fold change||Inter-Quartile Range|Median
1392091|NCT01335971|Secondary|Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group|Inflammatory markers were measured in bronchial alveolar lavage samples at baseline and 4 weeks in the participants of this trial who had bronchoalveolar lavage samples obtained.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had bronchial alveolar lavage samples available. Samples were missing for two participants in the placebo group.|||fold change||Inter-Quartile Range|Median
1392092|NCT01335971|Secondary|Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)|Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.|||fold change||Inter-Quartile Range|Median
1392093|NCT01335971|Secondary|Fold-change in Isoprostane Concentrations (Follow-up to Baseline)|Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with expired breath condensate samples in which testing could be successfully performed. Samples were missing for two participants in the 25 micromole group and one participant in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
1392094|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks|The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one participant in the 25 micromole group, and one participant in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
1392095|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks|The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and two in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
1392096|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks|The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group.|||fold change||Inter-Quartile Range|Median
1392097|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks|The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and one in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
1392123|NCT01335932|Secondary|SF-36 Functional Assessment Mental Component|Mental Component Summary at 180 days post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability|at 180 days post-randomization||||scores on a scale||Standard Deviation|Mean
1392098|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks|The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group and one in the 25 micromole group..|||fold change||Inter-Quartile Range|Median
1392099|NCT01335971|Primary|Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks|The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one in the 25 micromole group, and one in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
1392100|NCT01335932|Secondary|Number of Hospital-free Days Among Subjects by Day 28|Number of hospital-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
1392101|NCT01335932|Secondary|Number of ICU-free Days Amongst Subjects by Day 28|Number of ICU-free days amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
1392102|NCT01335932|Secondary|Number of Days in ICU Amongst Subjects by Day 28|Number of days in ICU amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
1392103|NCT01335932|Secondary|Number of Ventilator-free Days Among Subjects by Day 28|Number of ventilator-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
1392104|NCT01335932|Secondary|Number of Mechanically Ventilated Days Among Subjects by Day 28|Number of mechanically ventilated days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
1392105|NCT01335932|Secondary|Mortality Among Subjects Mechanically Ventilated From Day 7 to 14|Mortality among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||events|||Number
1392106|NCT01335932|Secondary|Number of Hospital-free Days|Number of hospital-free days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
1392107|NCT01335932|Secondary|Number of Days in the Hospital|Number of days in the hospital amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
1392108|NCT01335932|Secondary|Number of ICU-free Days|Number of ICU-free days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
1392109|NCT01335932|Secondary|Number of Days in the ICU|Number of days in the ICU amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
1392110|NCT01335932|Secondary|Number of Ventilator-free Days|Number of ventilator-free days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
1392111|NCT01335932|Secondary|Number of Mechanical Ventilated Days|Number of mechanical ventilated days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
1392112|NCT01335932|Secondary|Overall Mortality|Overall mortality amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||events|||Number
1392113|NCT01335932|Secondary|Bacteremia and Fungemia Outcomes in Mechanically Ventilated Subjets|Bacteremia and fungemia events among subjects who are mechanically ventilated for at least 7 through 14 days after randomization|at 7 through 14 days post-randomization||||events|||Number
1392114|NCT01335932|Secondary|Bacteremia and Fungemia Outcomes|Bacteremia and fungemia outcomes among subjects who survive at least 7 days|at 7 days post-randomization||||events|||Number
1392115|NCT01335932|Secondary|Clinical Outcomes|Composite of survival status and >7 days ventilation status, and IL-6 levels. In the composite analysis, the endpoint is composed by death, ventilation status and change of cytokine.|at 14 days post-randomization||||Participants|||Count of Participants
1392116|NCT01335932|Secondary|Platelet Transfusions|Platelet transfusions per patient|by 35 days post-randomization||||transfusions||Inter-Quartile Range|Median
1392117|NCT01335932|Secondary|Red Blood Cell Transfusions Required Per Patients|Red blood cell transfusions required per patients by day 35|by 35 days post-randomization||||transfusions||Inter-Quartile Range|Median
1392118|NCT01335932|Secondary|Renal Insufficiency|Number of patients experiencing a glomerular filtration rate < 60mL/min at day 35|by 35 days post-randomization||||Participants|||Count of Participants
1392119|NCT01335932|Secondary|Use of Granulocyte-colony Stimulating Factor|Number of participants requiring Granulocyte-colony stimulating factor|by 35 days post-randomization||||Participants|||Count of Participants
1392120|NCT01335932|Secondary|Time to Neutropenia|Time to neutropenia by 35 days post-randomization|by 35 days post-randomization||||days|||Number
1392121|NCT01335932|Secondary|Patients With Serious Adverse Events|Number of patients with Serious Adverse Events by day 35|by 35 days post-randomization||||Participants|||Count of Participants
1392122|NCT01335932|Secondary|SF-36 Functional Assessment Mental Component on Day 1|SF-36 Mental Component Summary at 1 day post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability|at 1 day post-randomization||||scores on a scale||Standard Deviation|Mean
1392124|NCT01335932|Secondary|SF-36 Functional Assessment Physical Component|Physical Component Summary at 180 days post- randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability|at 180 days post-randomization||||scores on a scale||Standard Deviation|Mean
1392125|NCT01335932|Secondary|Mortality at 180 Days|Mortality at 180 days post-randomization|at 180 days post-randomization||||Participants|||Count of Participants
1392126|NCT01335932|Secondary|Mortality|Mortality at 60 days post randomization|at 60 days post-randomization||||Participants|||Count of Participants
1392127|NCT01335932|Secondary|Bacteremia and/or Fungemia|Number of participants with bacteremia and/or fungemia|at 28 days post-randomization||||Participants|||Count of Participants
1392128|NCT01335932|Secondary|Duration of Mechanical Ventilation as Assessed by Ventilator Days|Number of days of mechanical ventilation duration as assessed by ventilator days|at 28 days post-randomization||||days||Standard Deviation|Mean
1392129|NCT01335932|Secondary|Duration of Mechanical Ventilation as Assessed by Ventilator Free Days|Number of days of mechanical ventilation duration as assessed by ventilator free days|at 28 days post-randomization||||days||Standard Deviation|Mean
1392130|NCT01335932|Secondary|Organ System Failure at 28 Days|Number of participants with organ system failure at 28 days|at 28 days post-randomization||||Participants|||Count of Participants
1392131|NCT01335932|Secondary|Length of Stay|Hospital days alive and not hospitalized by day 28|by 28 days post-randomization||||days||Standard Deviation|Mean
1392132|NCT01335932|Secondary|Length of Stay|Hospital days alive and not hospitalized by day 180|by 180 days post-randomization||||days||Standard Deviation|Mean
1392133|NCT01335932|Secondary|AUC Plasma Levels of Soluble ICAM-1|AUC Plasma levels of soluble ICAM-1 from day 0 to day 28|at 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
1392134|NCT01335932|Secondary|AUC Plasma Levels of TNF-a|AUC Plasma levels of TNF-a from day 0 to day 28|at 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
1392135|NCT01335932|Secondary|AUC Plasma Levels of IL-10|AUC Plasma levels of IL-10 from day 0 to day 28|at 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
1392136|NCT01335932|Secondary|AUC Plasma Levels of IL-8|AUC Plasma levels of IL-8 from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
1392137|NCT01335932|Secondary|AUC Plasma Levels of IL-6|AUC Plasma levels of IL-6 from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
1392138|NCT01335932|Secondary|Peak Plasma Levels of IL-6|Peak Plasma levels of IL-6 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392139|NCT01335932|Secondary|Peak Plasma Levels of IL-8|Peak Plasma levels of IL-8 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392140|NCT01335932|Secondary|Peak Plasma Levels of IL-10|Peak Plasma levels of IL-10 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392141|NCT01335932|Secondary|Peak Plasma Levels of TNF-a|Peak Plasma levels of TNF-a at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392142|NCT01335932|Secondary|Peak Plasma Levels of Soluble ICAM-1|Peak Plasma levels of soluble ICAM-1 from day 0 to day 28|Day 0 to 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392143|NCT01335932|Secondary|Plasma Levels of Soluble ICAM-1|Plasma levels of soluble ICAM-1 at day 7|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392144|NCT01335932|Secondary|Plasma Levels of Soluble ICAM-1|Plasma levels of soluble ICAM-1 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392145|NCT01335932|Secondary|Plasma Levels of IL-8|Plasma levels of IL-8 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392146|NCT01335932|Secondary|Plasma Levels of IL-6|Plasma levels of IL-6 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392147|NCT01335932|Secondary|Plasma Levels of TNF a|Plasma levels of TNF a from day 0 to day 28|Day 0 to 28 days post-randomization|Cytokines are summarized on a log 10 scale. When the logged value is negative, the raw value would be less than 1.|||log 10 pg/mL||Standard Deviation|Mean
1392148|NCT01335932|Secondary|Plasma Levels of TNF a|Plasma levels of TNF a at day 7.Cytokines are summarized on log 10 scale. When logged value is negative, the raw value would be less than 1.|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392149|NCT01335932|Secondary|Plasma Levels of IL-8|Levels of IL-8 in plasma at day 7|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392150|NCT01335932|Secondary|Plasma Levels of IL-6|Plasma levels of IL-6.|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
1392151|NCT01335932|Secondary|BAL Levels of TNFa|Levels of TNFa in BALs at day 7|at 7 days post-randomization|The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.|||log 10 pg/mL||Standard Deviation|Mean
1392152|NCT01335932|Secondary|BAL Levels of IL-8|Levels of IL-8 in BALs at day 7|at 7 days post-randomization|The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.|||log 10 pg/mL||Standard Deviation|Mean
1392153|NCT01335932|Secondary|CMV Peak Viral Load in Blood|CMV Peak Viremia in blood at day 28|at 28 days post-randomization||||log 10 IU/mL||Standard Deviation|Mean
1392154|NCT01335932|Secondary|CMV AUC in Throat|CMV AUC in Throat from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
1392155|NCT01335932|Secondary|CMV AUC in Blood|CMV AUC in blood from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
1392156|NCT01335932|Secondary|Incidence of CMV Reactivation >1,000 IU Per mL at 28 Days in Throat|Number of participants with CMV reactivation >1,000 IU per mL at day 28 in throat|at 28 days post-randomization||||Participants|||Count of Participants
1392157|NCT01335932|Secondary|Incidence of CMV Reactivation at Any Level at 28 Days in Throat|CMV reactivation in baseline negatives at any level at day 28 in throat|at 28 days post-randomization||||Participants|||Count of Participants
1392174|NCT01335789|Primary|Stress (as Measured by Subjective Report)|Subjective report of stress was measured using a 0-10 Likert Scale (0=not at all, 10=extremely). Reported here is subjective stress level 5 minutes following exposure to the Trier Social Stress Task (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion||||units on a scale||95% Confidence Interval|Mean
1392175|NCT01335789|Secondary|Craving (as Measured by the Marijuana Craving Questionnaire)|The MCQ is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1–7 with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. Reported here is MCQ composite score 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion||||units on a scale||95% Confidence Interval|Mean
1392176|NCT01335789|Primary|Stress (as Measured by Cortisol)|Salivary cortisol samples were collected via passive drool to provide empirical assessment of stress reactivity. Reported here is salivary cortisol level 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion||||nmol/L||95% Confidence Interval|Mean
1392177|NCT01335750|Primary|Corneal Staining Area|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.|||units on a scale||Standard Deviation|Mean
1392178|NCT01335750|Primary|Corneal Staining Severity|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.|||units on a scale||Full Range|Mean
1392179|NCT01335750|Secondary|Subjective Dryness|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)|||units on a scale||Standard Deviation|Mean
1392180|NCT01335750|Secondary|Subjective Comfort|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)|||units on a scale||Standard Deviation|Mean
1392181|NCT01335724|Secondary|Neck Disability Index|"Neck Disability Index total score. Minimum = 0 Best. Maximum = 50 Worst"|96h||||Total Score||Standard Deviation|Mean
1392182|NCT01335724|Secondary|Pain at Rest|"Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|96h||||mm||Standard Deviation|Mean
1392183|NCT01335724|Primary|Pain on Movement|"Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|48 h||||mm||Standard Deviation|Mean
1392184|NCT01335698|Secondary|Number of Participants With Emergent Genotypic Substitutions|Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level >200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level <50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and <1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor|Baseline through Week 48|All participants with virologic failure.|||Participants|||Number
1392185|NCT01335698|Secondary|CD4 Cell Count Changes From Baseline|Last observation carried forward: missing values are replaced with the last on-treatment value in the previous visit window;if a patient does not have an on-treatment value, baseline value is carried forward. Baseline observation carried forward: missing values are replaced with the baseline value; if a patient does not have a baseline the first on-treatment value is carried forward.|Baseline to Weeks 24 and 48|All participants with both baseline and time point results|||Cells/mm^3||Standard Error|Mean
1392186|NCT01335698|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality|Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug. n=number of participants evaluable|||Participants|||Number
1392187|NCT01335698|Primary|Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event|The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug.|||Participants|||Number
1392188|NCT01335698|Primary|Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.|Day 1 of treatment through Week 48|All participants who received at least 1 dose of study drug|||Participants|||Number
1392189|NCT01335698|Secondary|CD4 Percent Changes From Baseline||Baseline to Weeks 24 and 48|All participants with both baseline and time point results; n=number of participants evaluable at time point|||Percent change||Standard Error|Mean
1392190|NCT01335698|Secondary|HIV RNA Changes From Baseline||Baseline to Weeks 24 and 48|All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results|||Log copies per millileter||Standard Error|Mean
1392191|NCT01335698|Secondary|Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort|Virologic success includes patients with HIV RNA <50 copies/mL. Two cohorts were assess: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment.|Day 1 of treatment to Weeks 24 and 48|For efficacy of atazanavir powder to Week 24: Atazanavir Powder Cohort. For efficacy of atazanavir powder efficacy to Week 48 (n): Eligible Week 48 Atazanavir Powder Cohort|||Participants|||Number
1392192|NCT01335685|Secondary|Assessments of Quality of Life (Phase 2)||Baseline, Day 1 of each treatment cycle, and Day 1 of each maintenance cycle, up to 5.5 years|Assessments of quality of life parameters were not analyzed due to change in planned analysis.||||||
1392193|NCT01335685|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.|From first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||participants|||Number
1392194|NCT01335685|Secondary|Overall Survival (Phase 2)|Overall Survival is the time in months from start of study treatment to date of death due to any cause.|From date of enrollment to date of death, approximately 5.5 years (Approximate median follow-up: 43.6 months)|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
1392195|NCT01335685|Secondary|Progression Free Survival (Phase 2)|Progression Free Survival is defined as time in months from start of study treatment to first documentation of objective tumor progression per investigator assessment or up to death due to any cause, whichever occurs first. Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder.|From the date of enrollment to the date of the first documented disease progression or death due to any cause for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
1392196|NCT01335685|Secondary|Time to Next Therapy (Phase 2)|Time to Next Therapy is defined as time from the date of enrollment to the date of subsequent antineoplastic therapy.|From the date of enrollment to the date of subsequent antineoplastic therapy for up to 5.5 years|Time to next therapy was not analyzed due to the change in the planned analysis.||||||
1392197|NCT01335685|Secondary|Time to Progression (TTP) (Phase 2)|TTP is defined as time from date of enrollment to date of first documented disease progression (PD). Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder.|From the date of enrollment to the date of the first documented disease progression for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
1392222|NCT01335477|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA- Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392198|NCT01335685|Secondary|Duration of Response (DOR) (Phase 2)|DOR is defined as time of first documentation of a confirmed PR or better response to first documented PD or start of alternative therapy. DOR was presented for those achieving CR+VGPR+PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.|From the time from the date of first documentation of PR or better to the date of first documented disease progression for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
1392199|NCT01335685|Secondary|Time to First Response (Phase 2)|Response is defined as CR, VGPR and PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.|From the date of enrollment to the date of the first documented response for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
1392200|NCT01335685|Secondary|Overall Response Rate (ORR)|ORR is defined as percentage of participants with overall response including CR, VGPR, and partial response (PR). Per IMWG criteria, CR:1)Negative immunofixation on serum and urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. If serum+urine M-protein are unmeasurable and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.|Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) up to 61 cycles, at end of treatment (Up to 5.5 years)|The response-evaluable population is defined as participants who received at least 5 of 8 MLN9708 doses in Arm A, at least 2 of 3 MLN9708 doses in Arm B, at least 4 of 5 MLN9708 doses in Arm C, or at least 3 of 4 MLN9708 doses in Arm D and had measurable disease at baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1392201|NCT01335685|Secondary|Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)|Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.|Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||ratio||Standard Deviation|Mean
1392202|NCT01335685|Secondary|Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||hours||Standard Deviation|Mean
1392203|NCT01335685|Secondary|Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||1/hour||Standard Deviation|Mean
1392204|NCT01335685|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)||Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||hr*ng/mL||Standard Deviation|Mean
1392205|NCT01335685|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)||Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||hours||Full Range|Median
1392206|NCT01335685|Secondary|Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)||Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The pharmacokinetics (PK) population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||ng/mL||Standard Deviation|Mean
1392207|NCT01335685|Secondary|Time of Occurrence of Emax (TEmax) (Phase 1)|Whole blood 20S proteasome inhibition parameters|At multiple time points during Cycles 1-3 of each phase and arm of the study, throughout approximately 84-126 days depending on the arm of the study|The efficacy endpoint of maximum inhibition rate was not performed due to the change in the planned analysis.||||||
1392209|NCT01335685|Primary|Very Good Partial Response (VGPR) or Better Response Rate (Phase 2)|VGPR or better response rate is defined as percentage of participants with a complete response (CR) and very good partial response (VGPR). Per International Myeloma Working Group Uniform Response Criteria (IMWG), CR: 1) Negative immunofixation on the serum and urine, 2) Disappearance of any soft tissue plasmacytomas and 3) < 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour.|Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) until death (Up to 5.5 years)|The response-evaluable population is defined as participants who received at least 5 of 8 MLN9708 doses in Arm A, at least 2 of 3 MLN9708 doses in Arm B, at least 4 of 5 MLN9708 doses in Arm C, or at least 3 of 4 MLN9708 doses in Arm D and had measurable disease at baseline and at least 1 post-baseline response assessment.|||percentage of participants|||Number
1392210|NCT01335685|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Ixazomib (Phase 1)|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1).|Cycle 1, phase 1 (Up to 42 days)|Dose Limiting Toxicity population included participants who received at least 80% of doses of MLN9708 and melphalan during Cycle 1 in Arms A or all doses of MLN9708 and melphalan during Cycle 1 in Arm B, C, D, or experience a DLT in Cycle 1 in the phase 1 dose escalation portion.|||mg|||Number
1392211|NCT01335542|Primary|"The Primary Outcome is Time Until a Patient is Ready for Discharge."|"The primary outcome is time until a patient is ready for discharge. Discharge criteria are:~PCA (if present) has been discontinued~Not experiencing moderate or severe nausea (within last 4 hours).~Solid food diet~Able to urinate (Foley catheter removed)~Pain: NRS <4.~Surgical wound dry~No acute medical problems~Physical Therapy Criteria~Independently transfer from supine to sit, from sitting to standing~Ambulate 40 ft. without assistance~Extension range of motion (< 10 degrees)"|Participants will be followed for the duration of their hospital stay, an expected average of 3 days||||days||Inter-Quartile Range|Mean
1392212|NCT01335477|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||mmol/min/kPa||Standard Error|Mean
1392213|NCT01335477|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent of oxygen saturation||Standard Error|Mean
1392214|NCT01335477|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set|||percentage of participants|||Number
1392215|NCT01335477|Secondary|Time to Death or Lung Transplant Over 52 Weeks|Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period).|52 weeks|Treated Set|||percentage of participants|||Number
1392216|NCT01335477|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set|||percentage of participants|||Number
1392217|NCT01335477|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set|||percentage of participants|||Number
1392218|NCT01335477|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period)."|52 weeks|Treated Set|||percentage of participants|||Number
1392219|NCT01335477|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set|||Participants/Year *100|||Number
1392220|NCT01335477|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set|||points on a scale||Standard Deviation|Mean
1392221|NCT01335477|Secondary|Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
1392223|NCT01335477|Secondary|Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392224|NCT01335477|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392225|NCT01335477|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392226|NCT01335477|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392227|NCT01335477|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392228|NCT01335477|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392229|NCT01335477|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks.~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|baseline and 52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
1392230|NCT01335477|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
1392231|NCT01335477|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
1392232|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)|||percentage of participants|||Number
1392233|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)|||percentage of participants|||Number
1392234|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
1392235|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||%predicted||Standard Error|Mean
1392236|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
1392237|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||mL||Standard Error|Mean
1392238|NCT01335477|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set|||percentage of participants|||Number
1392239|NCT01335477|Secondary|Change From Baseline in Saint George’s Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392240|NCT01335477|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate."|52 weeks|Treated Set|||mL/year||Standard Error|Mean
1392241|NCT01335464|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||mmol/min/kPa||Standard Error|Mean
1392242|NCT01335464|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent of oxygen saturation||Standard Error|Mean
1392243|NCT01335464|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1392244|NCT01335464|Secondary|Time to Death or Lung Transplant Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1392245|NCT01335464|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1392246|NCT01335464|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1392247|NCT01335464|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period) ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1392248|NCT01335464|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||Participants/Year *100|||Number
1392772|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction|Percentage of patients reporting Individual component of primary endpoint: non-fatal Myocardial Infarction|From baseline up to 4.9 years|Anlysis was conducted on the ITT population|||Percentage of patients|||Number
1392249|NCT01335464|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient’s health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Deviation|Mean
1392250|NCT01335464|Secondary|Proportion of Patient’s Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
1392251|NCT01335464|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA-Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392252|NCT01335464|Secondary|Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392253|NCT01335464|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392254|NCT01335464|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392255|NCT01335464|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on scale||Standard Error|Mean
1392256|NCT01335464|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392257|NCT01335464|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392258|NCT01335464|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
1392259|NCT01335464|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
1392260|NCT01335464|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
1392261|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)|||percentage of participants|||Number
1392262|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)|||percentage of participants|||Number
1392263|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
1392264|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||% predicted||Standard Error|Mean
1392265|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
1392266|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||mL||Standard Error|Mean
1392267|NCT01335464|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days~New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit~Exclusion of infection as per routine clinical practice and microbiological studies~Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
1392268|NCT01335464|Secondary|Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint.~SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
1392269|NCT01335464|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate"|52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||mL/year||Standard Error|Mean
1392270|NCT01335308|Secondary|Change in Physical Activity||2 years after enrollment||||Adjusted posttest hours per day||Standard Error|Mean
1392271|NCT01335308|Secondary|Sweetened Beverage Consumption||2 years after enrollment||||Adjusted posted test servings per day||Standard Error|Mean
1392272|NCT01335308|Secondary|Fruit/Vegetable Consumption||2 years after enrollment||||Post test adjuste, servings per day||Standard Error|Mean
1392273|NCT01335308|Primary|Child BMI Percentile||2 years after recruitment||||BMI Percentile||Standard Error|Mean
1392274|NCT01335230|Primary|Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.|We measure gene transcription of the colon tissues (relative expression fold changes of gene transcription compared to control). No preselected criteria were used to assess the participants. Data were analyzed and compared among each group. Relative expression levels of LEAP-2 (Liver expressed anti-microbial peptide-2) in the four groups were shown in the table below. Detailed of other genes had been published in Shata MT, et al, J. Clin Pathology 2013, Nov 66(11):967-75. PMID 23940131, and Abdel-Hameed et al, J. Acquir Immune Defic Syndr. 2013 Jul 10 PMID: 23846566|One year|All the samples were analyzed for gene array transcriptions and cytokines profiles|||relative expression levels||Standard Deviation|Mean
1392275|NCT01335204|Secondary|Progression-free Survival (PFS)|Determination of progression-free survival in subjects treated with cabazitaxel + bavituximab for CRPC previously treated with docetaxel. PFS will be assessed continually during the entire study.|24+ weeks|This study terminated early, so outcomes were not analyzed.||||||
1392276|NCT01335204|Secondary|Number of With Grade 3 or 4 Toxicities|To document the toxicity of cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Toxicity will be assessed continually during the 24 wks of study therapy.|24 weeks||||grade 3 or 4 toxicities|||Number
1392277|NCT01335204|Secondary|Overall Survival|To estimate the overall survival in subjects with CRPC (previously treated with docetaxel) following cabazitaxel + bavituximab therapy. Overall survival will be assessed continually during the duration of the study.|24+ weeks|This study terminated early, so outcomes were not analyzed.||||||
1392278|NCT01335204|Secondary|Objective Response Rate by RECIST for Patients With Measurable Disease|To estimate the objective response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Objective response rate will be assessed at day 85, 169|24 weeks|This study terminated early, so outcomes were not analyzed.||||||
1392279|NCT01335204|Secondary|Measurement of PSA Response Rate|To estimate the PSA response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. PSA response rate will be assessed at multiple time points during the 24 wks of study treatment.|24 weeks|This study terminated early, so outcomes were not analyzed.||||||
1392280|NCT01335204|Primary|Probability of Progression-free Survival at Day 85|The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.|12 weeks|This study terminated early, so outcomes were not analyzed.||||||
1392281|NCT01335191|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|54 weeks|all subjects enrolled|||ng/mL||Full Range|Mean
1392282|NCT01335061|Secondary|Incidence of Less Than Expected Therapeutic Effect (LETE)|The following criteria are the definitions for LETE in this study: 1. LETE in the On-Demand Setting: LETE occurs in the on-demand setting if 2 successive “No Response” ratings are recorded after 2 successive BeneFIX drug infusions in the absence of confounding factors. 2. LETE in the Prophylaxis Setting: LETE occurs in the prophylaxis setting if there is a spontaneous bleed within 48 hours (≤ 48 hours) after a regularly scheduled prophylactic dose of BeneFIX in the absence of confounding factors. 3. LETE (Low Recovery): LETE can also be lower than expected recovery of FIX in the opinion of the investigator following infusion of BeneFIX in the absence of confounding factors. Each reported occurrence of low recovery LETE was listed.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||Percentage of occurence|||Number
1392283|NCT01335061|Secondary|Total Factor Consumption.|The total amount (IU) infused for each infusion recorded were summed to calculate the total factor consumption for each participant. For each infusion, IU/kg was calculated, using the most recently recorded weight measurement and the total factor consumption, divided by number of infusions, and was summarized similarly to average infusion dose (IU). Annualized TFC by weight was reported. Annualized TFC by weight = (Total IU/kg / treatment interval duration)*365.25.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||IU/Kg||Standard Deviation|Mean
1392284|NCT01335061|Secondary|Average Infusion Dose.|The mean dose by per infusion by weight (IU/kg) was reported for both prophylaxis and on demand infusions|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||IU/Kg||Standard Deviation|Mean
1392285|NCT01335061|Secondary|Number of Breakthrough (Spontaneous/Non-Traumatic) Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX.|The number of spontaneous, non-traumatic breakthrough bleeds within 48 hours following a prophylaxis dose of BeneFIX were summarized. If there was more than one bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Three participants experienced 1 spontaneous bleeding episode each within 48 hours of a previous prophylaxis infusion.|||Number of breakthrough bleeds|Participants|Standard Deviation|Mean
1392286|NCT01335061|Secondary|Number of Nonacog Alfa, Recombinant Factor IX (BeneFIX) Infusions Used to Treat Each Bleeding Episode.|The number of study drug infusions administered to treat a bleed will be calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time). The number of infusions needed to treat a bleed will be classified into the following categories: 1, 2, 3, 4 and >4 infusions. If there were more than one bleed location (e.g., ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||Number of bleeds requiring infusion|Participants||Number
1392287|NCT01335061|Secondary|Response to On-Demand Treatment for All Bleeding Episodes.|Assessment scores on a 4-point Response Scale for an on-demand bleeding episode, as assessed by participant/caregiver or investigator/qualified staff. The 4-point scale assessments are Excellent, Good, Moderate or No response. Responses to number of observations were noted.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Follow-up infusion was only required for 18 participants.|||Number of observations with response|Participants||Number
1392288|NCT01335061|Primary|Annualized Number of Bleeding Episodes.|The annualized bleed rate (ABR) or the annualized number of bleeding episodes per year, will be derived for each participant for each treatment period by using the following formula: ABR = number of bleeds / (Days on treatment period / 365.25) The number of bleeds for the ABR calculation includes all bleeds requiring treatment with factor IX product during the time on treatment.|2 years|The efficacy analysis set (EAS) was used for the primary efficacy analyses with respect to ABR. It includes all participants who participated in at least one day of the routine prophylaxis period (ie, in the study through at least Visit 4).|||Number of bleeds per year||Standard Deviation|Mean
1392289|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|"Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|6 hours||||units on a scale||95% Confidence Interval|Mean
1392290|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours||||Number of Adverse Events|||Number
1392291|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours||||Number of Serious Adverse Events|||Number
1392292|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours||||Number of Adverse Events|||Number
1392293|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours||||Number of Serious Adverse Events|||Number
1392294|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent adverse events occurring through extended dosing.|24 hours||||Number of Events|||Number
1392295|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent serious adverse events occurring through extended dosing.|24 hours||||Number of Serious Adverse Events|||Number
1392296|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).|"The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|4 hours||||units on a scale||95% Confidence Interval|Mean
1392297|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever|The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration|4 hours||||Degree Fahrenheit||95% Confidence Interval|Mean
1392298|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).|1 hour||||mm Hg||95% Confidence Interval|Mean
1392299|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).|1 hour||||mm Hg||95% Confidence Interval|Mean
1392300|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).|1 hour||||Breaths Per Minute||95% Confidence Interval|Mean
1392301|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).|1 hour||||Beats Per Minute||95% Confidence Interval|Mean
1392302|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting|The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)|1 hour||||Degree Fahrenheit||95% Confidence Interval|Mean
1392303|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.|6 hours|This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen|||Number of Events|||Number
1392304|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours||||Number of Serious Adverse Events|||Number
1392305|NCT01334918|Secondary|Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT|Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT.|Day 1 and Day 2|Full analysis set participants with two or more reversible defects.|||percentage of participants|||Number
1392306|NCT01334918|Secondary|Number of Participants With Fixed Defects|"Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect.~At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.|||participants|||Number
1394123|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1392307|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)|"The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.|||participants|||Number
1392308|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)|"The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.|||participants|||Number
1392309|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)|"The number of reversible defects in the LAD categorized into absence or presence of ischemia (0–1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.|||participants|||Number
1392310|NCT01334918|Secondary|Overall Image Quality of Scans by Modality and Reviewer|Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP).|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.|||participants|||Number
1392311|NCT01334918|Primary|Number of Participants With Reversible Defects|"The number of reversible defects categorized into absence or presence of ischemia (0–1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set, defined as all randomized patients with interpretable SPECT and CTP scans as determined by at least two of the three blinded readers.|||participants|||Number
1392312|NCT01334866|Secondary|Composite Major Adverse Event Rate (Late)|"Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:~Major hemorrhage/bleeding requiring surgical intervention~Aortic complications~Graft vessel revision (GVR)~Transient ischemic attacks (TIA)~Cerebrovascular accidents (CVA)/stroke~Myocardial infarction (MI)~Death"|After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation||||percentage of subjects|||Number
1392313|NCT01334866|Primary|Composite Major Adverse Event Rate (Early)|"During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include:~Major hemorrhage/bleeding requiring surgical intervention~Aortic complications~Graft vessel revision (GVR)~Transient ischemic attacks (TIA)~Cerebrovascular accidents (CVA)/stroke~Myocardial infarction (MI)~Death"|During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)||||percentage of subjects||95% Confidence Interval|Number
1392314|NCT01334866|Primary|Patency of the Index Graft at 6 Months|"For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results.~The FitzGibbon Scoring system is as follows:~A:Excellent graft with unimpaired runoff (< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to <50% of the grafted coronary artery.~O:Occluded (100% stenosed)"|6 months post-procedure||||percentage of grafts|Participants||Number
1394124|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1392315|NCT01334866|Primary|Procedural Success in a MICS Approach|A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.|At time of procedure (day 1)||||percentage of subjects|||Number
1392316|NCT01334866|Primary|Technical Success (Graft Patency) in a MICS Approach|For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.|At time of procedure (day 1)||||percentage of grafts|Participants||Number
1392317|NCT01334723|Secondary|BPH-Related Costs for Every 30 Days of 5-ARI Therapy|In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
1392318|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
1392319|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
1392320|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
1392321|NCT01334723|Secondary|Mean Length of 5-ARI Therapy|In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||days||Standard Deviation|Mean
1392322|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||participants|||Number
1392323|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||participants|||Number
1392324|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%|Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.|The 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population: participants in the IHCIS database with a diagnosis of benign prostate hyperplasia or enlarged prostate as indicated by ICD-9-CM code on claims (222.2x or 600.xx). Participants were included if they had at least 60 days of 5-ARI therapy during the enrollment period, 6 months of continuous enrollment, and no prior surgery.|||participants|||Number
1392325|NCT01334710|Secondary|Toxicity Assessment|Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.|28 days from study entry||||Participants|||Count of Participants
1392326|NCT01334710|Primary|Comparison of MRI/CT Scans to Pre-treatment Scan|Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.|6 months|Trial was terminated early.||||||
1392327|NCT01334606|Secondary|User Acceptability|"After using each pen needle for three weeks, subjects will be asked to respond Yes or No to the question Were the pen needles used for long acting insulin injections at doses greater than 40 units during this past study period acceptable to you? This outcome measure will be determined for the total subject population as well as for the subset of Lantus users."|End of Period 1 (three weeks) and Period 2 (six weeks)|||||||
1392328|NCT01334606|Secondary|Relative Injection Pain|"Subjects will complete a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm). The sign of each VAS score will be adjusted for the order of pen needle (PN) use, such that the 8mm short PN is always considered the reference."|End of Period 2 (six weeks)|||||||
1392329|NCT01334606|Secondary|Percentage of Subjects With at Least One Leakage Event|Leakage will be assessed by the subject after any injections of long-acting insulin of greater than 40 units. Subjects will record in their study diary if they observed insulin leakage from the injection site.|3 weeks per pen needle|||||||
1392330|NCT01334606|Secondary|Glycemic Control as Measured by Fasting Blood Glucose|The measure of glycemic control will be the percent difference in fasting blood glucose (FBG) assessed at the end of Period 1 and Period 2. The average percent difference in FBG between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusted for baseline FBG. This outcome measure will be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle|||||||
1392331|NCT01334606|Primary|Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine|The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle|No analysis was performed. The study was terminated due to slow enrollment. The same endpoint was studied and reported in a similar subject population, including Lantus users, in study DBC-11-SQUIR05(NCT01231984)which had a similar design.||||||
1392332|NCT01334554|Secondary|Endothelial Function|Endothelial function was measured with flow mediated dilation, percent change|Difference between FMD at baseline and 4 weeks|We detected problems with the ultrasound images obtained to measure flow mediated dilation and therefore only data in 14 subjects in the sildenafil group and in 16 subjects in the placebo were analyzed.|||percentage of brachial artery diameter|percent change of brachial artery diamet|Standard Deviation|Mean
1392333|NCT01334554|Primary|Insulin Sensitivity|insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test|Insulin sensitivity measured at baseline and 4 weeks after the intervention||||min-1/pmol/mlx10-5||Standard Deviation|Median
1392334|NCT01334515|Secondary|Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST)|Number of patients where best overall response is a complete response (CR)-[disappearance of all target lesions and disappearance of any other measureable disease], a very Good Partial Response (VGPR)- [>90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], or partial Response (PR)- [>= 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], and maintains the response. It is possible that a subject’s response to therapy may not occur until after several months of treatment. In order to prevent bias, the maximum duration of time/treatment over which a subject’s response is to be assessed for determination of the best overall response is after the completion of up to 10 courses.|Every two cycles (each cycle lasts 28 days)|Patients will be evaluable for inclusion in the analysis of response if they have an event at any time on the study or if they complete at least 2 cycles of hu14.18-IL2 therapy. Patients who go off-protocol therapy prior to the completion of 2 cycles due to parent/family choice and/or due to toxicity will not be considered evaluable for response.|||participants|||Number
1392335|NCT01334515|Primary|Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs)|Test for tolerability and monitor for the occurrence of too many unacceptable DLTs using a two-stage stopping rule: (Stage 1) Accrue 10 patients. If more than 1 experience at least one unacceptable DLT during the first treatment cycle, the regimen will be considered to have unacceptable toxicity, and accrual will be temporarily closed, to review all relevant data and consider modifying the regimen to improve safety. If 1 or no patients have an unacceptable DLT in the first treatment cycle, then continue. (Stage 2) Accrue 20 more patients. If 7 or more experience at least one unacceptable DLT in the first treatment cycle, temporarily close the study for possible dosing-safety modifications. If 6 or fewer have an unacceptable DLT in the first treatment cycle, it is reasonable to assume that the combination therapy is safe.|Up to 10 courses|This outcome measure evaluates the first 30 patients to enroll and who receive at least one dose of hu14.18-IL2.|||participants|||Number
1392336|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Fractional Catabolic Rates With Stable Isotope During Postprandial Period||6 weeks||||pools/day||Standard Deviation|Mean
1392337|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Pool Sizes With Stable Isotope During Postprandial Period||6 weeks||||mg||Standard Deviation|Mean
1392338|NCT01334229|Secondary|Measurement of Insulin||6 weeks||||pmol/L||Standard Deviation|Mean
1392339|NCT01334229|Secondary|Measurement of Glucose||6 weeks||||mmol/L||Standard Deviation|Mean
1392340|NCT01334229|Secondary|Measurement of Glucagon-like Peptide-1 by ELISA||6 weeks||||pmol/L||Standard Deviation|Mean
1392341|NCT01334229|Primary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Production Rates With Stable Isotope During Postprandial Period||6 weeks||||mg/kg/day||Standard Deviation|Mean
1392342|NCT01334216|Primary|Parental Smoking Quit Rate|This is the number of participants who quit smoking|one year||||Participants|||Count of Participants
1392343|NCT01334125|Secondary|Number of Participants With Minor, Major, and Nocturnal Hypoglycemia|Comparison of the occurrence of hypoglycemic event requiring a third party assistance (major hypoglycemia) per subject during the study, and minor hypoglycemia (plasma glucose of <60 mg/dL or no measurement), as well as nocturnal hypoglycemia (plasma glucose of ≤60 mg/dL between 11PM and 6AM).|12 months||||participants|||Number
1392344|NCT01334125|Secondary|Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time|Comparison of the baseline-adjusted differences in adiponectin/leptin ratio over time between the metformin and the placebo groups. The reported values represented mean adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6 mo, and 9 months||||ratio||95% Confidence Interval|Mean
1392345|NCT01334125|Secondary|Baseline Adjusted Changes in Lipid Profile Over Time|Comparison of the baseline-adjusted differences in total cholesterol/high density cholesterol index over time between the metformin and the placebo groups. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months||||ratio||95% Confidence Interval|Mean
1392346|NCT01334125|Primary|Baseline Adjusted Hemoglobin A1c Over Time|Comparison of the baseline-adjusted differences in HbA1c between the metformin and placebo groups during the trial. Hemoglobin A1c is a marker of glycemic control. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months||||percentage of HbA1c||95% Confidence Interval|Mean
1392347|NCT01333956|Secondary|Satisfaction|Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)|2 weeks||||units on a scale||Inter-Quartile Range|Median
1392348|NCT01333956|Secondary|Opioid Usage|Opioid Usage (POD1, POD 3, 2 weeks, 3 months)|3 months||||mg||95% Confidence Interval|Mean
1392349|NCT01333956|Secondary|Neuropathic Pain|Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.|3 months||||units on a scale||Inter-Quartile Range|Median
1392350|NCT01333956|Secondary|Numeric Rating Scale (NRS)|NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)|3 months||||units on a scale||95% Confidence Interval|Mean
1392351|NCT01333956|Secondary|Self-assessed Sedation and Confusion|Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)|1 day postoperatively||||percentage of patients|||Number
1392352|NCT01333956|Secondary|Opioid-Related Symptom Distress Score|Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).|2 weeks postoperatively||||units on a scale||Inter-Quartile Range|Median
1392353|NCT01333956|Primary|Postoperative Pain|Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).|2 weeks postoperatively||||units on a scale||Standard Deviation|Mean
1392354|NCT01333943|Secondary|Total Length of Hospital Stay||Total length of hospital stay||||days||Standard Deviation|Mean
1392355|NCT01333943|Secondary|Incidence of Postoperative Complications.||Postoperative day 4.||||Participants|||Count of Participants
1392356|NCT01333943|Secondary|Patient Satisfaction With the Nerve Block.|Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).|24 hours following administration of anesthesia.|One patient was excluded from analysis, and the remaining 93 patients were included.|||units on a scale||Standard Deviation|Mean
1392357|NCT01333943|Secondary|NRS Pain Scores at Rest|Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.|Postoperative day 4.|One patient was excluded at the time of analysis, and the remaining 93 patients were included in the analysis.|||units on a scale||Standard Deviation|Mean
1392358|NCT01333943|Secondary|Total Opioid Usage|Opioid consumption data were collected and converted to oral morphine equivalents.|Postoperative day 4.|One patient was excluded from analysis due to a condition. Data from the remaining 93 patients were analyzed.|||mg||Standard Deviation|Mean
1392359|NCT01333943|Primary|Quadriceps Muscle Strength|Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.|48 hours following administration of anesthesia.||||kilogram-force||Standard Deviation|Mean
1392360|NCT01333865|Secondary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score|Number of participants with reduction in ASD symptom severity defined as an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2. The CGI-Improvement is a clinician-rated measure of improvement. Scores range from 1 (very much improved) to 7 (very much worse) for PDD.|Pre-treatment - 12 weeks|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.|||participants|||Number
1392361|NCT01333865|Primary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)|"Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%.~The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings."|Week 12|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.|||participants|||Number
1392362|NCT01333813|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1)|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.|||Participants|||Count of Participants
1392363|NCT01333813|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.|||Participants|||Count of Participants
1392364|NCT01333813|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and temeperature.~Any temperature was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 temperature was axillary temperature > 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination."|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.|||Participants|||Count of Participants
1392365|NCT01333813|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local symptoms assessed were pain, redness and swelling. Any was occurrence of any local symptom regardless of their intensity grade. Grade 3 pain was considerable pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was > 50 millimeter (mm).|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine .|||Participants|||Count of Participants
1392366|NCT01333813|Secondary|Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose|The anamnestic response is defined as an antibody concentration ≥ 10 mIU/mL at post Engerix-B Kinder challenge dose time point for initially seronegative subjects ,and as an antibody concentration at post Engerix-B Kinder challenge dose time point ≥ 4 fold the pre-vaccination antibody concentration for initially seropositive subjects. A seropositive/seronegative subject was defined as subject with HBs antibody concentration below/greater than or equal to the seropositivity cut-off of 6.2 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|After Engerix-B Kinder challenge dose (Month 1)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
1392367|NCT01333813|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1392368|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL) and ≥ 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
1392369|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL), ≥ 10 mIU/mL, ≥ 10 mIU/mL to <100 mIU/mL and ≥ 100 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
1392411|NCT01333397|Other Pre-specified|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study|Treatment Emergent Adverse Event (TEAE)|Up to Day 113 (±3 days)|Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected|||participants|||Number
1392370|NCT01333813|Secondary|Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.|"Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL.~A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis."|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1392371|NCT01333813|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
1392372|NCT01333722|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||minutes||95% Confidence Interval|Median
1392373|NCT01333722|Secondary|SPRID (Pain Relief and Pain Intensity Difference)|"SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
1392374|NCT01333722|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
1392375|NCT01333722|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
1392376|NCT01333592|Primary|Incidences of Adverse Events||52 weeks||||Participants|||Number
1392377|NCT01333592|Secondary|Change From Baseline in HbA1c at 52 Weeks||at week 0 and week 52||||percentage of HbA1c||Standard Deviation|Mean
1392378|NCT01333501|Secondary|Changes in the Environmental Status Scale Score (ESS)|The Environmental Status Scale (ESS) is used to quickly evaluate a patient for handicap. It was derived from a measure of socio-economic status. It consists of seven parameters: (1) actual work status, (2) financial and economic status, (3) personal residence or home, (4) personal assistance required, (5) transportation, (6) community services, (7) social activity. Each parameter has a single score from minimum 0 to maximum 5. ESS score is the sum of the points for all 7 parameters: minimum score: 0; maximum score: 35. The higher the score the greater the handicap|Baseline, 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Score||Standard Deviation|Mean
1392379|NCT01333501|Secondary|Change From Screening in the Percentage of Brain Volume Change|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||percentage of brain volume||Standard Deviation|Mean
1392559|NCT01332578|Secondary|AUC (0-60 Min)|AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||ng*h/mL||Standard Deviation|Mean
1392380|NCT01333501|Secondary|Change From Screening in the Number of T1 Gd+ Enhancing Lesions|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Number of new lesions||Standard Deviation|Mean
1392381|NCT01333501|Secondary|Change From Screening in the Volume of Total T1 Hypointense Lesions|Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Means were estimated using a Mixed-effect model with repeated measures (MMRM) by-visit interaction.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||mm^3||Standard Deviation|Mean
1392382|NCT01333501|Secondary|Change From Screening in the Number of New T2 Lesions|New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (visit 8 to 18 month) is calculated as the sum of the number of lesions.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Number of new lesions||Standard Deviation|Mean
1392383|NCT01333501|Secondary|Changes From Baseline in Fatigue Impact Scale (mFIS, Total Score and Scores of the 3 Individual Domains).|Modified Fatigue Impact Scale (mFIS) questionnaire is described at each time point to evaluate fatigue by means of usual descriptive statistics. Three domains were also defined: Physical Subscale (sum of items 4, 6, 7, 10, 13, 14, 17, 20, 21 and therefore ranging from 0 to 36), Cognitive Subscale (sum of items 1, 2, 3, 5, 11, 12, 15, 16, 18, 19 and therefore ranging from 0 to 40) and Psychosocial Subscale (sum of items 8, 9 and therefore ranging from 0 to 8). Finally, mFIS - overall score ranged from 0 to 80. The mFIS total score was computed as the sum of scores for each item. Lower values represent a better outcome.|Baseline, 18 months|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Score||Standard Error|Least Squares Mean
1392384|NCT01333501|Secondary|Changes in Quality of Life, by Means of the Multiple Sclerosis Quality of Life (MSQoL-54)|A 54 question measure covers 12 domains; assesses mental and physical health. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. Each domain has a range from 0 to 100 where higher means better.|Baseline, 18 months|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Score||Standard Error|Least Squares Mean
1392385|NCT01333501|Secondary|Change From Screening in Montgomery-Asberg Depression Rating Scale (MADRS)|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392386|NCT01333501|Secondary|Change From Screening in the Volume of Total T2 Lesions|Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume|Screening (-1 month), 18 months||||mm^3||Standard Deviation|Mean
1392387|NCT01333501|Primary|Change From Screening in DKEFS Condition 2: Sort Recognition, Sort Recognition Description Score- Card Set 1+2|The Delis-Kaplan Executive Function System – Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient’s executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. Free sorting and sort recognition. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores. The total score ranged from 0 to 64. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392395|NCT01333501|Primary|Change From Screening in Symbol Digit Modalities Test (SDMT) Raw Score|Symbol Digit Modality Test (SDMT) for sustained attention and information processing speed. It presents a series of nine symbols, each of which is paired with a single digit labeled 1-9 in a key at the top of the sheet. The reminder of the page has a pseudo-randomized sequence of symbols, and the patient must respond with the digit associated with each of these as quickly as possible. The score is the number of correct answers in 90 seconds. The total score ranged from 0 to 110. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1393501|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP24|This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein.|Baseline and Up to Day 35|Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome.|||Ratio to Baseline||Standard Deviation|Geometric Mean
1392388|NCT01333501|Primary|Change From Screening in DKEFS Condition 1: Free Sorting, Free Sorting, Description Score, Card Set 1+2|The Delis-Kaplan Executive Function System – Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient’s executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores. In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets. The total score ranged from 0 to 64. Higher values represent a better outcome|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392389|NCT01333501|Primary|Change From Screening in Delis-Kaplan Executive Function System (DKEFS) Condition 1: Free Sorting, Confirmed Correct Sort- Card Set 1+2|The Delis-Kaplan Executive Function System – Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient’s executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. The DKFES test consisted of two testing procedures: free sorting and sort recognition. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts. In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets. The total score ranged from 0 to 16. Higher values represent a better outcome|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392390|NCT01333501|Primary|Change From Screening in Word List Generation (WLG)|Word List Generation (COWAT/WLG): The COWAT assesses verbal fluency on semantic stimulus by asking the patient to produce as many words as possible belonging to a semantic category. The test assessed the verbal fluency, recorded all the possible correct word that a patients should give in 90 sec. No maximum range is available. Higher values represent a better outcome. The score was the number of correct words. The more words the patient pronounces, the better it is. We can imagine that the minimum value might be zero words, , but it is not a score scale.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392391|NCT01333501|Primary|Change From Screening in Spatial Recall Test – Delayed Recall (SPART-D)|Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D). A checkerboard with ten checkers arranged in a pattern was shown to the subject for ten seconds. The subject was then asked to reproduce the same pattern with ten checkers on an empty checkerboard. The test includes three consecutive trials. The score was the total number of correct responses for the tree trials. The total score ranged from 0 to 10. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392392|NCT01333501|Primary|Change From Screening in Selective Reminding Test – Delayed Recall (SRT-D) Raw Score|The tests SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). The Delayed SRT test is the total number of words recalled after a delayed period. The total score ranged from 0 to 12. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392393|NCT01333501|Primary|Change From Screening in Paced Auditory Serial Addition Test – 2 (PASAT 2) Raw Score|Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed). The patient hears a series of numbers from recordings that are presented at the rate of one every 2 seconds in the second part of the test (PASAT-2). The patient was asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers. The total score ranged from 0 to 60. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392394|NCT01333501|Primary|Change From Screening in Paced Auditory Serial Addition Test – 3 Seconds (PASAT 3) Raw Score|Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed). The patient hears a series of numbers from recordings that are presented at the rate of one every 3 seconds in the first part of the test (PASAT-3). The patient is asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers. The total score ranged from 0 to 60. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392396|NCT01333501|Primary|Change From Screening in Spatial Recall Test (SPART) Raw Score|Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D). A checkerboard with ten checkers arranged in a pattern is shown to the subject for ten seconds. The subject is then asked to reproduce the same pattern with ten checkers on an empty checkerboard. The test includes three consecutive trials. The score is the total number of correct responses for the tree trials. The total score ranged from 0 to 30. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
1392397|NCT01333501|Primary|Change From Screening in Selective Reminding Test – Consistent Long Term Retrieval (SRT-CLTR) Raw Score|Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity. It consists of the serial administration of 5 tests. One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials. The total of the words in LTS of all six trials is then summed. If a word in LTS is consistently recalled on all subsequent trials, it is then scored as Consistent Long Term Retrieval (CLTR). The total of the words in CLTR of all six trials is summed. The total score ranged from 0 to 72. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations.|||Raw score||Standard Error|Least Squares Mean
1392398|NCT01333501|Primary|Change From Screening in Selective Reminding Test – Long-Term Storage (SRT-LTS) Raw Score|Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity. It consists of the serial administration of 5 tests. One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials. The total of the words in LTS of all six trials is then summed. The total score ranged from 0 to 72. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations.|||raw score||Standard Error|Least Squares Mean
1392399|NCT01333488|Secondary|Vasospasm|as measured by TCD (Transcranial Doppler)|up to 3 months||||Percentage of participants|||Number
1392400|NCT01333488|Secondary|GOS|GOS score|12 months after injury||||GOS score||Full Range|Mean
1392401|NCT01333488|Primary|GOS (Glasgow Outcome Score)|"GOS=5 (Good Recovery) - Capacity to resume normal occupational and social activities, although some there may be some minor physical or mental deficits or symptoms.~GOS=4 (Moderate Disability) - Independent and can resume almost all activities of daily living.~GOS=3 (Severe Disability) - No longer capable of engaging in most previous personal, social or work activities. Typically are partially or totally dependent on assistance from others in daily living.~GOS=2 ( Persistent Vegetative State ) GOS=1 (Dead)"|Discharge from Hospital - Within 2 months from Injury||||units on a scale||Full Range|Mean
1392402|NCT01333475|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|29 months, 23 days||||participants|||Number
1392403|NCT01333475|Primary|pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer|A predetermined target inhibition reduction of 70% of both pERK and pAKT was deemed significant, thus tumor biopsies were performed at C1D1 or C1D22 post administration and evaluated using quantitative chemiluminescence immunoassay to measure pERK and pAKT levels in human tissue.|C1D1 and C1D22 post administration of the combination of AZD6244 hydrogen sulfate and MK-2206||||pg/ µg of protein||Full Range|Mean
1392404|NCT01333436|Secondary|Fasting ApoB-48 Levels|ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).|Baseline (Hour 0)|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.|||μg/mL||Standard Deviation|Mean
1392405|NCT01333436|Secondary|Postprandial Mean ApoB-48 Peak Levels|ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.|||μg/mL||Standard Deviation|Mean
1392406|NCT01333436|Primary|Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)|ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.|||μg/mL x h||Standard Deviation|Mean
1392407|NCT01333397|Secondary|Percentage of Subjects as Responders at Day 29 by the Investigator’s Live Assessment and by Subject’s Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)||Day 29|ITT Population; N’=number of subjects with an assessment at Day 29|||percentage of subjects|||Number
1392408|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator’s Live Assessment at Rest (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit|||percentage of subjects|||Number
1392409|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Subject’s Self Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment|||percentage of subjects|||Number
1392412|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
1392413|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit|||percentage of subjects|||Number
1392414|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator’s live assessment|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
1392415|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 113|ITT Population; N’=number of responders at Day 29|||percentage of subjects|||Number
1392416|NCT01333397|Secondary|Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.|A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit;|||percentage of subjects|||Number
1392417|NCT01333397|Secondary|Percentage of Subjects Assessed as Responders, by Both the Investigator’s Live Assessment and the Subject’s Self-assessment at Maximum Frown.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
1392418|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject’s Self-assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
1392419|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator’s Live Assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
1392420|NCT01333397|Secondary|Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 29|ITT Population; Day 29 (N'=34,36,35,33,35); N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
1392421|NCT01333397|Primary|Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown|"Investigator’s live assessment (ILA), subject’s self assessment (SSA), Next Generation (NG)~4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3;~4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3;~A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2."|Day 29|Intent-to-Treat Population: The intent-to-treat (ITT) population included all randomised subjects who received study treatment, regardless of the actual amount injected. N’=number of subjects with assessment|||percentage of subjects|||Number
1392422|NCT01333189|Secondary|Hip, Knee, and Ankle Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||Newton-meters per kilogram (Nm/kg)||Standard Error|Mean
1392423|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||meters/second||Standard Deviation|Mean
1392471|NCT01332994|Secondary|Change in CRP From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change was calculated as [mean CRP at Week 32 minus mean CRP at Week 16] and expressed in mg/dL.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||mg/dL||Standard Deviation|Mean
1392424|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
1392425|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||seconds||Standard Deviation|Mean
1392426|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||ratio||Standard Deviation|Mean
1392427|NCT01333189|Secondary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||ratio||Standard Deviation|Mean
1392428|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
1392429|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||meters/second||Standard Deviation|Mean
1392430|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
1392431|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||seconds||Standard Deviation|Mean
1392432|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||ratio||Standard Deviation|Mean
1392433|NCT01333189|Primary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||ratio||Standard Deviation|Mean
1392434|NCT01333111|Secondary|Host Cell Proteins (HCP) Antibodies|Subjects who were positive for anti-HCP antibodies.|28 weeks after treatment start on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||number of subjects|||Number
1392435|NCT01333111|Secondary|Host Cell Proteins (HCP) Antibodies|Subjects who were positive for anti-Host Cell Protein (HCP) antibodies.|52 weeks after treatment start for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||number of subjects|||Number
1392436|NCT01333111|Secondary|Incidence of Serious Adverse Events (SAEs)|SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).|at 32 weeks ±2 weeks for patients on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||number of SAEs per PYE|||Number
1392437|NCT01333111|Secondary|Incidence of Serious Adverse Events (SAEs)|SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).|at 56 weeks ±2 weeks for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||number of SAEs per PYE|||Number
1392438|NCT01333111|Secondary|Incidence of Adverse Events (AEs)|The incidence of adverse events were summarised by the rate of AEs (number of AEs per PYE). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).|at 32 weeks ±2 weeks for patients on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol.Subjects in on-demand arm were included for this analysis.|||number of AEs per PYE|||Number
1392439|NCT01333111|Secondary|Incidence of Adverse Events (AEs)|The incidence of adverse events were summarised by the rate of AEs (number of AEs per patient years of exposure [PYE]). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).|at 56 weeks ±2 weeks for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||number of AEs per PYE|||Number
1392440|NCT01333111|Secondary|Factor IX Trough Levels|The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Lowest factor IX activity recorded during single-dose and steady state, immediately before next dose was given. The analysis was based on a mixed model on the log-transformed plasma factor IX activity with subject as a random effect. The estimated mean factor IX trough level was presented back-transformed to the natural scale.|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||U/mL||95% Confidence Interval|Mean
1392441|NCT01333111|Secondary|Number of Bleeding Episodes Per Patient During Routine Prophylaxis|The number of bleeding episodes per patient during routine prophylaxis was assessed using the individual annualised bleeding rates (spontaneous and traumatic bleeding episodes per patient per year).|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||bleeds/patient/year||Inter-Quartile Range|Median
1392442|NCT01333111|Secondary|Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response|"Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.~Excellent – abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection~Good – noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection~Moderate – probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours~Poor – no improvement, or worsening of symptoms within 8 hours after two injections.~The success rate and 95% confidence interval (CI) are reported here."|28 weeks after treatment start on on-demand treatment|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||percentage of bleeding episodes||95% Confidence Interval|Number
1392443|NCT01333111|Secondary|Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response|"Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.~Excellent – abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection~Good – noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection~Moderate – probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours~Poor – no improvement, or worsening of symptoms within 8 hours after two injections.~The success rate and 95% confidence interval (CI) are reported here."|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||percentage of bleeding episodes||95% Confidence Interval|Number
1392444|NCT01333111|Primary|Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|28 weeks after treatment start on on-demand treatment|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||number of subjects|||Number
1392445|NCT01333111|Primary|Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||Number of subjects|||Number
1392468|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in mg/dL.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mg/dL||Standard Deviation|Mean
1392446|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Nonresponding Participants Treated With Rituximab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
1392447|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Participants Treated With 8 Courses of Tocilizumab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392448|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using FACIT at Week 16|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392449|NCT01332994|Secondary|Quality of Life as Assessed Using Functional Assessment of Chronic Illness Therapy (FACIT)|The FACIT-F evaluates quality of life using 5 categories: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and fatigue (FS). Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-General (FACIT-G; range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-Fatigue (FACIT-F) trial outcome index (TOI; range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392450|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to HAQ-DI Criteria|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Response was defined as a change in index score >0.22 from Baseline to Week 16.|Baseline and Week 16|Main ITT Population|||percentage of participants|||Number
1392451|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Nonresponding Participants Treated With Rituximab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
1392452|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Participants Treated With 8 Courses of Tocilizumab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
1392472|NCT01332994|Secondary|Change in Hemoglobin From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change was calculated as [mean hemoglobin at Week 32 minus mean hemoglobin at Week 16] and expressed in g/L.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||g/L||Standard Deviation|Mean
1392453|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using HAQ-DI at Week 16|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
1392454|NCT01332994|Secondary|Quality of Life as Assessed Using HAQ-DI|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392455|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Nonresponding Participants Treated With Rituximab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392456|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Participants Treated With 8 Courses of Tocilizumab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392457|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using SF-36 at Week 16|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392458|NCT01332994|Secondary|Quality of Life as Assessed Using Short Form 36 (SF-36)|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392459|NCT01332994|Secondary|Mean Number of Work Days Missed Per Week|Work days missed were documented by reason (either rheumatoid arthritis [RA] or other reasons) for each participant over the preceding 7-day period. The mean number of work days missed was calculated by averaging the number of days missed per week among all participants.|Baseline and Week 16|Main ITT Population. Employed participants with evaluable data at the designated visit (number shown = n) were included.|||days||Standard Deviation|Mean
1392460|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 32, 40, 48, and 66 Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 32, 40, 48, and 66|ITT3 Population; n = number of data pairs included in the analysis.|||coefficient|Participants||Number
1392469|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in g/L.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||g/L||Standard Deviation|Mean
1392461|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 24, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 24, and 32|ITT2 Population; n = number of data pairs included in the analysis.|||coefficient|Participants||Number
1392462|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Week 16 Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline to Week 16 in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Week 16|ITT1 Population; n = number of data pairs included in the analysis.|||coefficient|Participants||Number
1392463|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||percentage of B-cells||Full Range|Median
1392464|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||percentage of B-cells||Full Range|Median
1392465|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT1 Population: All participants who received at least one dose of TCZ in the first treatment period and who completed the study reaching remission at Week 16. Participants with evaluable data at the designated visit (number shown = n) were included.|||percentage of B-cells||Full Range|Median
1392466|NCT01332994|Secondary|Percentage of Participants Withdrawing From the Study for Insufficient Therapeutic Response|Study discontinuation was documented by reason for each participant prematurely withdrawing from the study. The percentage of participants was calculated as the number withdrawing for insufficient therapeutic response divided by the total number of participants who began treatment.|Baseline to Week 16|Main ITT Population. Participants who withdrew for reasons other than insufficient therapeutic response were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1392467|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in mm/h.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mm/h||Standard Deviation|Mean
1392470|NCT01332994|Secondary|Change in ESR From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change was calculated as [mean ESR at Week 32 minus mean ESR at Week 16] and expressed in mm/h.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||mm/h||Standard Deviation|Mean
1392473|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in millimeters per hour (mm/h).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mm/h||Standard Deviation|Mean
1392474|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in milligrams per deciliter (mg/dL).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mg/dL||Standard Deviation|Mean
1392475|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in grams per liter (g/L).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||g/L||Standard Deviation|Mean
1392476|NCT01332994|Secondary|Change From Baseline in CDAI and SDAI Scores at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392477|NCT01332994|Secondary|Change From Week 16 to 32 in CDAI and SDAI Scores Among Nonresponding Participants Treated With Rituximab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392478|NCT01332994|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Scores at Weeks 4, 8, 12, and 16|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392479|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population|||percentage of participants||95% Confidence Interval|Number
1392480|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from the reference visit (Week 16) of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Weeks 16 and 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
1392560|NCT01332578|Secondary|Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)|AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||nanograms (ng)*hours (h)/mL||Standard Deviation|Mean
1392481|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to American College of Rheumatology (ACR) Criteria at Weeks 4, 8, 12, and 16|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate a swollen joint count (SJC) ranging from 0 to 66 swollen joints and a tender joint count (TJC) ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP); plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
1392482|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population|||percentage of participants||95% Confidence Interval|Number
1392483|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit (Week 16). Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Weeks 16 and 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
1392484|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Weeks 4, 8, 12 and 16|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
1392485|NCT01332994|Secondary|DAS28 Scores During Safety Follow-Up Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Weeks 40, 48, 56, and 66|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392486|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 24, and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392487|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392488|NCT01332994|Secondary|DAS28 Scores During and After Treatment|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
1392498|NCT01332994|Primary|Percentage of Participants Achieving Remission at Week 16 According to DAS28|The DAS28 was calculated as [0.28 times (x) the square root of number of swollen joints] plus (+) [0.56 x the square root of number of tender joints] + [0.7 x the natural log of erythrocyte sedimentation rate (ESR)] + [0.014 x Visual Analog Scale (VAS) patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
1392489|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction in DAS28 From Week 16 to Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from the reference visit (Week 16) to the assessment visit were considered clinically relevant.|Weeks 16 and 32|ITT3 Population: All participants who received at least one dose of TCZ in the first treatment period and at least one dose of RTX in the second treatment period with at least one efficacy measurement under RTX.|||percentage of participants||95% Confidence Interval|Number
1392490|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Weeks 4, 8, and 12|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
1392491|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Week 16|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Week 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
1392492|NCT01332994|Secondary|Percentage of Participants Achieving LDAS According to DAS28 Among Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
1392493|NCT01332994|Secondary|Percentage of Participants Achieving Low Disease Activity Score (LDAS) According to DAS28|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
1392494|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
1392495|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT2 Population|||percentage of participants||95% Confidence Interval|Number
1392496|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 16, 20, 24, and 28 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 16, 20, 24, and 28|ITT2 Population: All participants who received at least one dose of TCZ in the first treatment period with at least one efficacy measurement under TCZ, receiving TCZ in the second treatment period.|||percentage of participants||95% Confidence Interval|Number
1392497|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 4, 8, and 12|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
1392667|NCT01332188|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392499|NCT01332981|Secondary|Prognostic Factors For Time to Progression|Prognostic factors for TTP were searched by using Cox regression model. First, all parameters were analysed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15% level were retained for multivariate model. For multivariate analyses, 2 models were built for prognostic factor of TTP. In Model 1, stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In Model 2, stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for exit was 5%. Six parameters remained in the Model 1 to search for prognostic factors of TTP. Once the correlated variables were removed, there were only 3 variables left in Model 2: the age was not kept by the stepwise selection. Results below are for Model 1 and similar results were obtained for Model 2|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Hazard Ratio||95% Confidence Interval|Number
1392500|NCT01332981|Secondary|Prognostic Factors for Overall Survival|Search for prognostic factors for OS was performed using Cox regression model. First, all parameters were analyzed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15%-level were retained for the multivariate model. For the multivariate analysis, two models were built for prognostic factors for OS. In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%. The variables n°5 and n°6 were found to be significantly associated, thus only the variable n°6 was tested in the Model 2. This variable was not retained by the stepwise selection in the Model 1, contrary to the variable n°5.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Hazard Ratio||95% Confidence Interval|Number
1392501|NCT01332981|Secondary|Median Treatment Duration and the Duration of Exposure to Trastuzumab|Treatment duration was defined as the time between the first and the last infusion of trastuzumab. Exposure duration was defined only for the participants who continued trastuzumab after HERMINE study, as the sum of treatment duration as part of HERMINE study and of the treatment durations as part of post-HERMINE study taking into account temporary treatment discontinuations. For analyses of treatment and exposure duration , dates of infusion of trastuzumab were missing for 18 participants, so treatment and exposure durations were calculated for only 202 participants.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||Full Range|Median
1392502|NCT01332981|Secondary|Median Time to Progression|The Time to Progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. If the cause of death was unknown, the death was considered for this analysis as due to the disease. All participants who did not progress, the death was considered to be due to the disease.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||95% Confidence Interval|Median
1392503|NCT01332981|Secondary|Median Time to Progression-Free Survival|The Progression-Free Survival (PFS) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. Progression-Free Survival was estimated by using Kaplan-Meier method.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||95% Confidence Interval|Median
1392504|NCT01332981|Primary|Median Overall Survival|The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||95% Confidence Interval|Median
1392505|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
1392506|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
1392507|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
1392508|NCT01332968|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)|The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
1392509|NCT01332968|Secondary|Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)|The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
1392510|NCT01332968|Secondary|Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)|The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
1392511|NCT01332968|Secondary|Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)|FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
1392512|NCT01332968|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.|||percentage of participants|||Number
1392513|NCT01332968|Secondary|Time to Next Anti-Lymphoma Treatment (Overall Study Population)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392514|NCT01332968|Secondary|Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392535|NCT01332851|Secondary|Maternal Unrealistic Expectations|Parent Opinion Questionnaire (POQ; Azar et al., 1984): questionnaire to assess unrealistic parental expectations of child behavior in the areas of self-care, help and affection to parents, leaving children alone, proper feelings and behavior punishment, and family responsibility. NOTE: THIS MEASURE WAS COLLECTED. RESPONDENTS WERE OFFENDED BY SOME QUESTIONS, WE REDUCED THE NUMBER OF QUESTIONS AT BASELINE AND COLLECTED THE FULL INSTRUMENT AT FOLLOW UP 1. HOWEVER, IT SHOWED LIMITED VARIABILITY. COMPARISONS BETWEEN PFR AND R&R CONDITIONS INDICATED NONSIGNIFICANT DIFFERENCES. DUE TO THE LIMITED VARIABILITY, IT WAS DECIDED NOT TO REPORT THESE RESULTS.|Baseline and Post intervention (~ 4 months post baseline)|||||||
1392515|NCT01332968|Secondary|Duration of Response (DOR) (Overall Study Population), Investigator-Assessed|DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.|From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)|Participants with CR or PR within the ITT population were included in the analysis. The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392516|NCT01332968|Secondary|Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed|DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.|From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months|Participants with CR or PR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392517|NCT01332968|Secondary|Disease-Free Survival (Overall Study Population)|Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months|Participants with CR within the ITT population were included in the analysis.The ITT population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392518|NCT01332968|Secondary|Disease-Free Survival (Follicular Lymphoma Population)|Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months)|Participants with CR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392519|NCT01332968|Secondary|Event-Free Survival (Overall Study Population)|Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392536|NCT01332851|Secondary|Parental Mindfulness|"About My Baby: three open-ended questions; coded to assess mindfulness representations of the child's mental life. NOTE: THIS MEASURE WAS DROPPED FROM THE STUDY. OPEN-ENDED QUESTIONS WERE INCLUDED IN INITIAL ASSESSMENTS. ANSWERS WERE REVIEWED BY THE RESEARCH TEAM, AND IT WAS DECIDED THAT RELIABLE AND VALID CODING WAS NOT POSSIBLE."|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|NOTE: THIS MEASURE WAS DROPPED FROM THE STUDY||||||
1392520|NCT01332968|Secondary|Event-Free Survival (Follicular Lymphoma Population)|Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392521|NCT01332968|Secondary|Overall Survival (Overall Study Population)|Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392522|NCT01332968|Secondary|Overall Survival (Follicular Lymphoma Population)|Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392523|NCT01332968|Secondary|Complete Response (Overall Study Population), IRC-Assessed|Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)]|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392524|NCT01332968|Secondary|Complete Response (Follicular Lymphoma Population), IRC-Assessed|Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392525|NCT01332968|Secondary|Overall Response (Overall Study Population), IRC-Assessed|Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392526|NCT01332968|Secondary|Overall Response (Follicular Lymphoma Population), IRC-Assessed|Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392527|NCT01332968|Secondary|Complete Response (Overall Study Population), Investigator-Assessed|Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392528|NCT01332968|Secondary|Complete Response (Follicular Lymphoma Population), Investigator-Assessed|Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1395581|NCT01305200|Secondary|Incidence of Febrile Neutropenia|Fever and Neutropenia = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||percentage of participants|||Number
1392529|NCT01332968|Secondary|Overall Response (Overall Study Population), Investigator-Assessed|Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392530|NCT01332968|Secondary|Overall Response (Follicular Lymphoma Population), Investigator-Assessed|Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392531|NCT01332968|Secondary|Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)|Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392532|NCT01332968|Secondary|Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed|Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392533|NCT01332968|Secondary|Progression-Free Survival in the Overall Study Population, Investigator-Assessed|Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392534|NCT01332968|Primary|Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed|Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The intent-to-treat follicular lymphoma population (FL ITT), defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
1392537|NCT01332851|Secondary|Parental Confidence|Caregiving Helplessness Questionnaire (CHQ; George, Coulson, Majany, & Soloman, 1995) subscales: parent-child frightened and parent helplessness. NOTE: THIS MEASURE WAS COLLECTED AND COMPARISONS BETWEEN PFR AND R&R INDICATED NONSIGNIFICANT DIFFERENCES. DUE TO LOW INTERNAL CONSISTENCY OF THE MEASURE, IT WAS DECIDED TO NOT REPORT PFR VS. R&R COMPARISONS FOR THIS MEASURE.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|||||||
1392538|NCT01332851|Secondary|Parent-Child Interaction (Video Recorded Observation Coded by Blind Coders)|"Coding Interactive Behavior-Child & Parent Outcomes (CIB; Feldman, 1998). Parent-child 10-minute free play interaction coded for child social engagement, child negative affect, and dyadic reciprocity; parental sensitivity and reciprocity, parental intrusiveness, and parental withdrawal.~NOTE: THIS MEASURE WAS COLLECTED AND CODED. HOWEVER, THE MEASURE SUFFERED FROM LOW INTERNAL CONSISTENCY AND RESTRICTED VARIATION (I.E., A LARGE PORTION OF SCORES WERE NEAR THE MAXIMUM POSSIBLE VALUE). WE DID COMPARE SCORES BY CONDITION AND ALL COMPARISONS INDICATED NONSIGNIFICANT DIFFERENCES BETWEEN PFR AND R&R CONDITIONS. DUE TO LOW RELIABILITY AND RESTRICTED VARIATION OF THE MEASURE, IT WAS DECIDED TO NOT REPORT THESE RESULTS."|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|||||||
1392539|NCT01332851|Secondary|Child Atypical Affective Communication (Observation)|Atypical, affective communication were measured with the Toddler Attachment Sort-45 (TAS-45; Kirkland, Bimler, Drawneek, McKim, & Schölmerich, 2004). The TAS-45 is based on 39 items from the Attachment Q-Sort (AQS; Waters, 1987), an attachment measure that has been extensively validated (van IJzendoorn, Vereijken, Bakermans-Kranenburg, & Riksen-Walraven, 2004), plus six additional items tapping atypical, affective communication. Immediately after research home visits, the research visitors sorted cards for 45 descriptive statements of child attachment behavior into five piles representing “most like” to “least like” the child. Item scores were standardized within individuals and then scaled with weights for the D hotspot. Because scores are based on standardized item scores, the possible range is large, difficult to determine, and not reported in the instrument manual. Observed range -1.511 to + .860.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: all 247 children were analyzed|||units on a scale||Standard Deviation|Mean
1392540|NCT01332851|Secondary|Child Engagement/Exploration|At baseline and again at the 3-month follow-up, blinded research visitors rated the child's behavior during administration of a standardized developmental test using the Bayley Behavior Rating Scales (BRS; Bayley 1993). Engagement/exploration consists of six items rated for exploratory behavior in the testing situation (alphas = .75–.76). The items were scored on a rage of 1 to 5, the mean of the six items was computed and the possible range is 1 to 5. Higher scores indicate more engagement.|Baseline and at the 3 month follow up (~ 7 months post baseline)|ITT: all 247 children were analyzed|||units on a scale||Standard Deviation|Mean
1392541|NCT01332851|Secondary|Child Emotion Regulation|Bayley Behavior Ratings (Bayley, 1993) to assess emotion regulation. At baseline and again at the 3-month follow-up, blinded research visitors rated the child's behavior during administration of a standardized developmental test using the Bayley Behavior Rating Scales (BRS; Bayley 1993). Seven items in the BRS comprise the emotion regulation scale and capture how well the child adapts to challenging stimuli and frustration (alphas = .79–.83). Possible range is 1 - 5, the mean of seven items scored from 1 to 5. Higher scores indicate better emotional regulation.|Baseline and at the 3 month follow up (~ 7 months post baseline)|ITT: all 247 children were analyzed|||units on a scale||Standard Deviation|Mean
1392542|NCT01332851|Secondary|Child Behavior Problems|Child behavior problems (31 items; alphas =.77–.79) were measured by parent report on the Brief Infant Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan & Carter, 2002). Descriptions of positive and problematic social-emotional behaviors in the last month were rated on a 3-point scale (not true/rarely; somewhat true/sometimes; very true/often; items score 0, 1, 2 respectively). Higher score indicates more child behavior problems as noted by the parent. Possible range is 0 - 62.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: all 247 children were included in the analysis.|||units on a scale||Standard Deviation|Mean
1392543|NCT01332851|Secondary|Child Social Emotional Development (Higher Scores Indicate More Competence)|Child social-emotional competence (11 items; alphas = .69–.70) was measured by the Brief Infant Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan & Carter, 2002). Possible range is 0 - 22. Parent report of child social-emotional competence in the last month were rated on a 3-point scale (not true/rarely; somewhat true/sometimes; very true/often). Higher scores indicate more competence.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: All 247 children were analyzed.|||units on a scale||Standard Deviation|Mean
1392544|NCT01332851|Secondary|Parent Stress: Competence (Higher Score Means More Stress)|At baseline, 3-month post-intervention follow-up, and 6-month post-intervention follow-up, parenting stress was measured by scales selected from the Parenting Stress Index and the Parenting Stress Index-Short Form (PSI-3, PSI-SF; Abidin, 1995). The Parenting Competence Scale from the PSI-3 (11 items) was used. Items were rated on 4-point scales (strongly agree to strongly disagree). Two items measuring parental educational attainment from the original parenting competence scale were omitted due to excessive missing data. Higher scores indicate greater parental stress associated with feelings of incompetence. Alphas ranged from .71–.94 across time points. Possible range 11 - 55, observed range 11 - 39.|Baseline 3-month post-intervention (~7 months post baseline), 6-month follow up (~ ten months post baseline)|ITT: All 247 parents were included in this analysis.|||units on a scale||Standard Deviation|Mean
1392545|NCT01332851|Secondary|Parenting Stress: Dysfunctional Interaction|Parenting stress was measured by scales selected from the Parenting Stress Index and the Parenting Stress Index-Short Form (PSI-3, PSI-SF; Abidin, 1995). The Parent-Child Dysfunctional Interaction Scale from the PSI-SF (11 items). Items were rated on 4-point scales (strongly agree to strongly disagree). Two items measuring parental educational attainment from the original parenting competence scale were omitted due to excessive missing data. Higher scores indicate greater parental stress associated with feelings of dysfunctional parent-child interactions (i.e., interactions are not reinforcing or satisfying). Alphas ranged from .71–.94 across time points. Possible range 11-55, observed range 12 to 43.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up from post intervention (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: All 247 parents were included in this analysis.|||units on a scale||Standard Deviation|Mean
1392668|NCT01332188|Secondary|Nasal Pruritus at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392546|NCT01332851|Primary|Secure Base Behavior (Observation During Research Visit; Higher Score Indicates Greater Security)|Secure base behavior was measured with the Toddler Attachment Sort-45 (TAS-45; Kirkland, Bimler, Drawneek, McKim, & Schölmerich, 2004). The TAS-45 is based on 39 items from the Attachment Q-Sort (AQS; Waters, 1987), an attachment measure that has been extensively validated (van IJzendoorn, Vereijken, Bakermans-Kranenburg, & Riksen-Walraven, 2004), plus six items tapping atypical affective communication. After home visits, research visitors sorted cards for 45 descriptive statements of child attachment behavior into five piles representing “most like” to “least like” the child. Item scores were standardized within individuals and then compared to a security profile to arrive at an security score. Higher value indicates greater secure base behavior. Because scores are based standardized item scores weighted by proximity to the secure profile, the possible range is large, difficult to determine, and not reported in the instrument manual. The observed range was from -.62 to +1.00.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|All 247 children in the study were included|||units on a scale||Standard Deviation|Mean
1392547|NCT01332851|Primary|Parental Sensitivity (Video Recorded Observation Coded by Blind Coders)|Parent sensitivity was measured at all four time points by a modified total score of the Nursing Child Assessment Teaching Scale (NCATS; Barnard, 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction were scored. The scale was modified to exclude some items from the original measure that demonstrated low variability in other studies. A total score was based on 45 items, possible range 0 - 45. Items covered mutuality (e.g. contingency, gaze, and positive affect), caregiver verbal and nonverbal support of child, and sensitive instruction during the teaching task. Items were scored yes (1) or no (0), and yes scores were summed. Cronbach’s alpha for the sensitivity scale ranged from .68 to .72. A single, blinded coder was trained to reliability by a certified NCATS instructor and passed regular reliability checks. Higher scores indicate greater parental sensitivity.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT, all 247 parents were coded on the sensitivity measure and were analyzed.|||units on a scale||Standard Deviation|Mean
1392548|NCT01332851|Primary|Child Welfare Outcomes: CWS Removal From Birth Parent Home|Official child welfare administrative records indicating whether child was removed from the birth parent home within one year of parent completing intervention (or one year after estimated date intervention would have been completed, for parents who did not complete). Data were analyzed with a survival model that predicted hazard of being removed from the birth parent home.|1 year post intervention||||participants|||Number
1392549|NCT01332721|Secondary|Objective Response According to RECIST 1.1|The best response according to RECIST 1.1 for each patient with measurable disease and who received at least one dose of study drug will be listed by cohort and tumor type|1.5 years||||participants|||Number
1392550|NCT01332721|Secondary|Immune Response to TRC105|HAMA and HACA titers will be measured at specified time-points.|1.5 years||||participants|||Number
1392551|NCT01332721|Secondary|TRC105 Pharmacokinetic Concentrations|Plasma TRC105 concentrations will be measured at specified timepoints.|1.5 years|||||||
1392552|NCT01332721|Primary|Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab|Safety and dose limiting toxicity will be assessed by dose cohort.|1.5 years||||mg/kg|||Number
1392553|NCT01332630|Primary|Overall Response Rate (ORR)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|8-24 weeks||||Participants|||Count of Participants
1392554|NCT01332578|Secondary|Time to Onset and Completion of Disintegration of Reference Tablets|Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.|Baseline to 10 hours post dose|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Tablet Disintegration endpoints were only measured in the first period for each participant.|||minutes||Standard Deviation|Mean
1392555|NCT01332578|Secondary|Time to Completion of Gastric Emptying|Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.|||minutes||Standard Error|Least Squares Mean
1392556|NCT01332578|Secondary|Time to Onset of Gastric Emptying|The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.|||minutes||Standard Error|Least Squares Mean
1392557|NCT01332578|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time after administration when the maximum plasma concentration was reached.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||hours||Full Range|Median
1392558|NCT01332578|Secondary|Maximum Plasma Concentration (Cmax)|Cmax was determined using plasma paracetamol concentration time profile.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||ng/mL||Standard Deviation|Mean
1392561|NCT01332578|Primary|Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)|Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.|Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|Modified Intent-To-Treat (MITT) population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||minutes||Full Range|Median
1392562|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
1392563|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
1392564|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||tablets per participant||Standard Deviation|Mean
1392565|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
1392566|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
1392567|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||tablets per participant||Standard Deviation|Mean
1392568|NCT01332487|Secondary|Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery||6 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed.|||participants|||Number
1392569|NCT01332487|Primary|Number of Participants Who Experienced Progression of Disease|The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.|Up to 5 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)|||participants|||Number
1392570|NCT01332461|Secondary|Mean Monthly COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge|||United States (US) dollars||Standard Deviation|Mean
1392571|NCT01332461|Secondary|Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge|||participants per 100 person-years|||Number
1392572|NCT01332461|Primary|Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge|||participants per 100 person-years|||Number
1392573|NCT01332435|Secondary|BPH-related Pharmacy Costs|Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population|||United States dollars||Standard Deviation|Mean
1392574|NCT01332435|Secondary|BPH-related Medical Costs|Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population|||United States dollars||Standard Deviation|Mean
1392575|NCT01332435|Secondary|Total BPH-related Costs|All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population|||United States dollars||Standard Deviation|Mean
1392576|NCT01332435|Primary|Number of Participants Who Needed Prostate-Related Surgery|Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population|||participants|||Number
1392577|NCT01332435|Primary|Number of Participants With Acute Urinary Retention|Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population|||participants|||Number
1392578|NCT01332435|Primary|Number of Participants With Clinical Progression|Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population: Men aged >=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy|||participants|||Number
1392579|NCT01332357|Primary|Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event|A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.|Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.|||participants|||Number
1392580|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Sleep Quality|"The PghSD assessed a participant's previous night's sleep. Sleep quality was assessed using a Visual Analogue Scale (VAS). Participants indicated their sleep quality by marking a vertical line on a horizontal scale anchored by responses very bad and very good. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point that the participant marked. Scores ranged from 0 to 100 mm with higher scores indicating better sleep quality and lower scores indicating worse sleep quality."|Baseline (Day -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."|||millimeters||Standard Deviation|Mean
1392669|NCT01332188|Secondary|Nasal Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392581|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item|The PghSD assessed a participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning after dose), and 16 (at Tmax)value minus the Baseline (Days -1 and 1) value. Total sleep time is expressed in hours.|Baseline (Days -1 and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."|||hours||Standard Deviation|Mean
1392582|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items|The PghSD assessed participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning), and 16 (at Tmax of GEn and DPH) value minus the Baseline (Days -1 and 1) value. Latency to sleep onset (time to fall asleep) and wake time after sleep onset are expressed in minutes.|Baseline (Days -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."|||minutes||Standard Deviation|Mean
1392583|NCT01332318|Secondary|Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep.|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
1392584|NCT01332318|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12 PM, 12 PM to 4 PM, 4 PM to 8 PM, 6 PM to 10 PM, 8 PM to 12 Midnight, Midnight to 4 AM, and 4 AM to 8 AM).|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
1392585|NCT01332318|Secondary|Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the|||percentage of participants|||Number
1392586|NCT01332318|Secondary|Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. For Arms 2 and 3, upper limits of the confidence intervals are not available, as they are beyond the 24-hour time frame.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the|||participants||95% Confidence Interval|Median
1392587|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14|"The participant-rated CGI-I is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale)."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
1392588|NCT01332318|Secondary|Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
1392589|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14|"The investigator-rated CGI-I is a clinician-rated assessment designed to allow clinicians to rate the change of their participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse compared to baseline. For this endpoint, response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale) compared to baseline."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
1392590|NCT01332318|Secondary|Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change of the disease severity over time based on a seven-point rating scale, with a score of 1 being “very much improved” and a score of 7 being “very much worse” compared to baseline.|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
1392670|NCT01332188|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392591|NCT01332318|Secondary|Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day -1) and Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||scores on a scale||Standard Deviation|Mean
1392592|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score|Participants (par.) were asked to look at 2 pictures simultaneously; each picture showed 3 different colored balls arranged on 3 pegs. Par. were to estimate the number of times the balls in 1 picture would have to be moved to make the arrangement of balls identical to that of the second picture. Par. were allowed 20 seconds to respond to each pair of pictures. The number of correct items was the TOL Score (range: 0-22). The TOL scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -7.53 to 2.76; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1392593|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score|Participants were given a list of numbers (numerals 1-9) that were each associated with a unique symbol. Participants decoded a list of 110 symbols as quickly as possible in 90 seconds. The total number of symbols correctly decoded was the Symbol Coding Score (range: 0-110). The Symbol Coding scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -7 to 10.08, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1392594|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score|Verbal Fluency included one semantic fluency and two letter fluency tasks. Participants were given 60 seconds to name as many words as possible within a given semantic category (supermarket items), and in two separate trials, participants were given 60 seconds to generate as many words as possible that began with a given letter. The total number of words from all of the 3 trials was the Verbal Fluency score (range: 0-150). The scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -5 to 10.83; higher scaled scores indicate better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1392595|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score|Participants were given 100 plastic tokens and asked to place them in a container, 2 at a time, as quickly as possible for 60 seconds. The number of tokens correctly placed in the container was the Token Motor Task score (range: 0-100). The BAC was conducted prior to each simulated driving test. The Token Motor Task scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -6.95 to 3.35, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1392596|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS)|Participants (par.) were presented with sets of numbers of increasing length and asked to tell the experimenter the numbers in order from lowest to highest. The task has 7 levels; the first level had 2 digits in the set (e.g., 5, 2); the second level had 3 digits in the set, etc. The number of times the par. correctly arranged the numbers was recorded as the score for each level. The DSS is the sum of the 7 level scores (range: 0-28). The scaled test score was calculated as indicated for the Verbal Memory Test and ranges from -6.68 to 2.73; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1392597|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score|Participants were presented with 15 words and asked to recall as many as possible; the procedure was repeated 5 times. The total number of words recalled correctly across the 5 administrations of the list was the participant’s Verbal Memory Recall score (range: 0-75). The scaled test score was calculated as ((BAC component raw test score - healthy control sample test mean)/healthy control sample test standard deviation); a healthy control sample was matched to the participant's sex and age category. The scaled test score range is -7.37 to 4.86; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1392671|NCT01332188|Secondary|Rhinorrhea at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392598|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score|The BAC was designed as a comprehensive measure of cognitive function, including 6 individual tests: Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London. The composite/total BAC score is calculated by scoring each individual test, comparing each score to a healthy control sample (matched for sex and age category) to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
1392599|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score|"The Epworth Sleepiness Scale (ESS) is a questionnaire designed to evaluate daytime sleepiness. Participants were asked to rate how likely they were to doze or fall asleep during 8 activities on a scale of 0 (would never do) to 3 (high chance of dozing). The total score ranges from 0-24, with a score greater than 10 representing excessive daytime sleepiness (an increased chance of dozing). Change from baseline was calculated as the Day 14 total score minus the Baseline total score."|Baseline (Day -1) and Day 14|Modified Intent-to-Treat (MITT) Population|||scores on a scale||Standard Deviation|Mean
1392600|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score|"Alertness VAS was completed immediately before and after each simulated driving assessment. Participants indicated their alertness by marking a vertical line on a horizontal scale anchored by responses extremely sleepy and extremely alert. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point the participant marked. Scores ranged from 0-100 mm, with higher scores indicating more alertness and lower scores indicating more sleepiness. Change score was calculated as the Day 14, 15, or 16 VAS score minus the Baseline VAS score."|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. Varying numbers of participants did not complete either the pre- or post-drive VAS at either Baseline or the day of assessment; as such, the number of participants analyzed varies by day.|||millimeters||Standard Deviation|Mean
1392601|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time|Brake reaction time was assessed as the time it took for each participant to move their foot off the accelerator and onto the brake pedal after the appearance of a stop sign on the simulation screen. Change from baseline was calculated as the Day 14, 15, or 16 mean reaction time minus the Baseline (Days -1 and 1) mean reaction time.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||seconds||Standard Deviation|Mean
1392602|NCT01332318|Secondary|Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)|A simulated crash was defined as a collision with an oncoming car or obstacle (e.g., tree) or when the distance to the center line was greater than 18 feet on either side of the road.|Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||participants|||Number
1392603|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed|Participants were instructed to maintain a speed of 55 miles per hour during the driving assessment. Change from baseline in overall average speed was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||miles per hour||Standard Deviation|Mean
1392604|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability|Speed variability was defined as the standard deviation of the speed (measured in miles per hour). Participants were instructed to maintain a speed of 55 miles per hour during the test drive. Change from baseline in overall speed variability was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed variability over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed variability over the 1-hour drive.|Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||miles per hour||Standard Deviation|Mean
1392605|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position|Lane position was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall average lane position was calculated as the Day 14 (in the evening), 15 (in the morning after GEn dosed at 5 PM), or 16 (assessment at Tmax of GEn and DPH) mean lane position over the 1-hour drive minus the Baseline (Days -1 and 1) mean lane position over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||feet||Standard Deviation|Mean
1392606|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 14 (in the evening) or Day 15 (in the morning after GEn dosed at 5 PM) mean LPV over the 1-hour drive minus the Baseline (Day -1 or Day 1) mean LPV over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14 and 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||feet||Standard Deviation|Mean
1392607|NCT01332318|Primary|Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH.|Baseline (Day -1) and Day 16|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who completed at least one Baseline and one End of Study (Days 14-16) simulated driving assessment. The number of participants assessed at each study day varies due to incomplete/missing data.|||feet||Standard Error|Least Squares Mean
1392608|NCT01332305|Primary|Mean AUCss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.|Weeks 4 and 12|Safety Population. Placebo participants were not included in the PK assessments, as they had no exposure to GEn. Of participants who completed the study, some were not included at Week 12 (sample not taken or below limit of quantitation).|||ng*hour/ml||Standard Deviation|Mean
1392609|NCT01332305|Primary|Mean Tmax and T1/2|Tmax is defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body.|Weeks 4 and 12|Safety Population. Placebo participants (par.) were not included in the PK assessments, as they had no exposure to GEn. At W4, there were two par. excluded from the T1/2, as a result of no sample taken or a PK profile not possible. Of par. who completed the study, some were not included at W12 (sample not taken or below limit of quantitation).|||hours||Standard Deviation|Mean
1392610|NCT01332305|Primary|Mean Css, Max and Css, Min|Css, max is defined as the maximum or “peak” concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation.|Weeks 4 and 12|Safety Population: all participants (par.) who were randomized and received at least one (or any portion of a) dose of study drug. Population was analyzed as randomized. Placebo par. had no exposure to GEn and were not included in the PK assessments. Of par. who completed the study, some were not included at W12 (sample not taken or BLQ).|||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
1392611|NCT01332292|Primary|Change From Baseline in the Indicated Electrocardiographic (ECG) Parameters at the Indicated Time Points on Day 14 of the Respective Treatment Period|PR, QRS, QT, QTcB, QTcF, and RR were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. Change from Baseline was calculated as the value at Day 14 minus the Baseline value. QTcB is the QT duration corrected for heart rate by Bazett’s formula. QTcF is the QT duration corrected for heart rate by Fridericia’s formula.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds (msec)||Standard Deviation|Mean
1392612|NCT01332292|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Days 1 and 14 of the Respective Treatment Period|The ex-throat dose (ETD) and the “nominal ETD” is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
1392613|NCT01332292|Secondary|Total Emitted Dose (TED) on Days 1 and 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
1392630|NCT01332292|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
1392614|NCT01332292|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilopascal (kpa)||Standard Deviation|Mean
1392615|NCT01332292|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
1392616|NCT01332292|Secondary|Inhalation Time on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Seconds||Standard Deviation|Mean
1392617|NCT01332292|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
1392618|NCT01332292|Secondary|Oropharyngeal Volume on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||cubic centimeters (cm^3)||Standard Deviation|Mean
1392619|NCT01332292|Secondary|Distance of Assessment on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of each treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters (cm)||Standard Deviation|Mean
1392643|NCT01332253|Secondary|Time to Swallow Post Procedure.|Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded.|every 15 minutes until able to swallow||||hours||Standard Error|Mean
1392644|NCT01332253|Secondary|Time to Discharge Post Procedure.|To evaluate the secondary objective of pain, the time to participant discharge will be measured.|Discharge||||hours||Standard Error|Mean
1392620|NCT01332292|Secondary|Average Oropharyngeal Cross-sectional Area on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters squared (cm^2)||Standard Deviation|Mean
1392621|NCT01332292|Secondary|Serum Cortisol Weighted Mean (0–12 Hours) on Day 14 of the Respective Treatment Period|Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time point were analyzed.|||nanomoles per Liter||95% Confidence Interval|Geometric Mean
1392622|NCT01332292|Secondary|Tmax and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population. Only those participant who had quantifiable FF concentrations were analyzed.|||hours||Standard Deviation|Mean
1392623|NCT01332292|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1392624|NCT01332292|Secondary|AUC(0-t) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC(0-t)) curve from time zero (pre-dose) to the last time of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. Due to non-quantifiable values, it was not possible to derive AUC(0-12).|Day 14 of the respective treatment period|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzed|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
1392625|NCT01332292|Primary|Heart Rate at Baseline and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Deviation|Mean
1392626|NCT01332292|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1392627|NCT01332292|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||liters/minute||Standard Deviation|Mean
1392628|NCT01332292|Primary|Total Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1392629|NCT01332292|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1393502|NCT01325311|Secondary|Levels of Calcitriol in Participants Serum|This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.|baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Mean
1392631|NCT01332292|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1392632|NCT01332292|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
1392633|NCT01332292|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed .|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
1392634|NCT01332292|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||percentage of red blood cells in blood||Standard Deviation|Mean
1392635|NCT01332292|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
1392636|NCT01332292|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1392637|NCT01332292|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1392638|NCT01332292|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 6)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication|||participants|||Number
1392639|NCT01332253|Secondary|Blood Loss During Surgery|Amount of Blood Lost During Surgery in milliliters|End of Surgery|Blood loss during surgery in milliliters|||milliliters||Standard Deviation|Mean
1392640|NCT01332253|Secondary|Parental Satisfaction With Vomiting Control in the Post-Operative Period.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to vomiting control. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 3 asked How satisfied were you with your child's vomiting management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with Vomiting Control.|||participants|||Number
1392641|NCT01332253|Secondary|Parent Satisfaction With Regards to Nausea Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to nausea management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 2 asked How satisfied were you with your child's nausea management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with nausea management during the study|||participants|||Number
1392642|NCT01332253|Secondary|Parent Satisfaction With Regards to Pain Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 1 asked How satisfied were you with your child's pain management at the time of discharge?"|Discharge|Summary of Parent Satisfaction Post-Procedure with Pain Management at the time of discharge?|||participants|||Number
1392645|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 120 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|120 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 120 minutes post-procedure.|||millimeters||Standard Deviation|Mean
1392646|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.|"o evaluate the secondary objective of pain, the patient's self-reported pain at 90 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|90 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 90 minutes post-procedure.|||millimeters||Standard Deviation|Mean
1392647|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 60 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|60 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 60 minutes post-procedure.|||millimeters||Standard Deviation|Mean
1392648|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.|"The patient's self-reported pain at 30 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|30 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 30 minutes post-procedure.|||millimeters||Standard Deviation|Mean
1392649|NCT01332253|Primary|Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.|To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.|4 hours||||fentanyl doses||Standard Deviation|Mean
1392650|NCT01332227|Secondary|Mean Changes in Fasting Lipid Levels From Baseline to Week 48|LD=low-density lipoprotein; HDL=high-density lipoprotein.|From Baseline to Week 48|All participants who received study drug|||mg/dL||Standard Error|Mean
1392651|NCT01332227|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to Week 48|All participants who received study drug|||Particpants|||Number
1392652|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 48|Participants with virologic rebound|||Participants|||Number
1392665|NCT01332188|Secondary|Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392666|NCT01332188|Secondary|Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1393503|NCT01325311|Primary|Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms|To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein|up to 35 days||||participants|||Number
1392653|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 24|Patients who received study drug, who had an HIV-1 RNA measurement at the analysis week and who experienced virologic rebound.|||Participants|||Number
1392654|NCT01332227|Secondary|Number of Participants With Virologic Rebound at Weeks 24 and 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.|Day 1 to Weeks 28 and 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.|||Participants|||Number
1392655|NCT01332227|Secondary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48|Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.|From Day 1 to Week 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.|||Percentage of participants||95% Confidence Interval|Number
1392656|NCT01332227|Primary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24|HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.|From Day 1 to Week 24|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.|||Percentage of participants||95% Confidence Interval|Number
1392657|NCT01332188|Secondary|Tolerability of Study Medication at Visit 3A|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome..|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392658|NCT01332188|Secondary|Nasal Composite Score at Onset of Action (15 Minutes Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||percentage of subjects|||Number
1392659|NCT01332188|Secondary|Nasal Composite Score at Duration of Action (24 Hours Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||percentage of subjects|||Number
1392660|NCT01332188|Secondary|Nasal Composite Score at Duration of Action (16 Hours Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||percentage of subjects|||Number
1392661|NCT01332188|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392662|NCT01332188|Secondary|Nasal Congestion at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC||||units on a scale||Standard Deviation|Mean
1392663|NCT01332188|Secondary|Nasal Congestion at Onset of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392664|NCT01332188|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392672|NCT01332188|Secondary|Rhinorrhea at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392673|NCT01332188|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392674|NCT01332188|Secondary|Tearing at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392675|NCT01332188|Secondary|Tearing at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392676|NCT01332188|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392677|NCT01332188|Secondary|Eyelid Swelling at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392678|NCT01332188|Secondary|Eyelid Swelling at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392679|NCT01332188|Secondary|Chemosis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392680|NCT01332188|Secondary|Chemosis at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392681|NCT01332188|Secondary|Chemosis at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392682|NCT01332188|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392683|NCT01332188|Secondary|Episcleral Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392684|NCT01332188|Secondary|Episcleral Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392685|NCT01332188|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1392686|NCT01332188|Secondary|Ciliary Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392687|NCT01332188|Secondary|Ciliary Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392688|NCT01332188|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392689|NCT01332188|Primary|Conjunctival Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392690|NCT01332188|Primary|Conjunctival Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392691|NCT01332188|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392692|NCT01332188|Primary|Ocular Itching at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392693|NCT01332188|Primary|Ocular Itching at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1392694|NCT01332149|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392695|NCT01332149|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392696|NCT01332149|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1392697|NCT01332149|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant’s perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392698|NCT01332149|Secondary|Clinical Global Impression of Change (CGIC) at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician’s perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392699|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392708|NCT01332149|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392700|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392701|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392702|NCT01332149|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||percentage of participants|||Number
1392703|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392704|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392705|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392706|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392707|NCT01332149|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. N=number of evaluable participants for each category|||units on a scale||Standard Deviation|Mean
1392773|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction|Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal Myocardial Infarction|From baseline up to 4.9 years|Anlysis was conducted on the ITT population.|||Months||95% Confidence Interval|Median
1392709|NCT01332149|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392710|NCT01332149|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1392711|NCT01332149|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9|SF-MPQ was assessed according to the participant’s answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 5, and 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. No inferential analyses were performed.|||units on a scale||Standard Deviation|Mean
1392712|NCT01332149|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline.|End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||percentage of participants|||Number
1392713|NCT01332149|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
1392714|NCT01332149|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1392715|NCT01332149|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1392716|NCT01332149|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
1392717|NCT01332149|Primary|Change From Baseline in Mean Pain Score at Endpoint|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Error|Least Squares Mean
1392718|NCT01332149|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1392719|NCT01332123|Secondary|Heart Rate Change|Subjects were wearing a wireless heart rate monitor. The respective readings were noted and assessed during and immediately following the trials to estimate individual exertion rates. Changes in heart rate between resting and exertion across the sample were investigated to be able to interpret the primary outcome measures and to discuss limitations of the protocol. Unequal exertion rates within the sample would cause uneven trends biomechanical changes that are related to exertion.|1 hour||||beats/minute||Full Range|Mean
1392720|NCT01332123|Primary|Overall Asymmetry Index|"Gait data was continuously recorded and was post processed to determine symmetry between left and right legs. Symmetry was computed by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.~The overall asymmetry index was calculated as the mean of the following: max knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), knee moment, dorsi-flexion moment, plantar-flexion moment, times of max in % of the gait cycle, Stance phase % of gait cycle and step length.~The kinematics asymmetry index was calculated as the mean of the following: maximal knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), the times of max in % of the gait cycle, Stance phase % of gait cycle and step length.~The kinetics asymmetry index was calculated as the mean of the following variables: knee moment, dorsi-flexion moment, plantar-flexion moment, the times of max in % of the gait cycle."|1 hour|Two of the recruited participants were not included in the analysis, as they had bilateral amputations. Bilateral amputation was not posted as an exclusion criteria initially, but posted unanticipated limitations during data collection and analysis.|||unit-less index (0 = perfect symmetry)||Standard Deviation|Mean
1392721|NCT01332071|Primary|Cmax of Metformin Hydrochloride|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
1392722|NCT01332071|Primary|AUC0-infinity of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
1392723|NCT01332071|Primary|AUC0-t of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
1392724|NCT01332071|Primary|AUC0-infinity of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
1392725|NCT01332071|Primary|Cmax of Rosiglitazone Maleate|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
1392726|NCT01332071|Primary|AUC0-t of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
1392727|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Main reason for missed injections? answer choices were given as medication side effects, injection pain, forget to take medication, tired of taking injections, don't think medication is working, or other. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment who missed at least 1 injection at given timepoint.|||participants|||Number
1392728|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Over the past 4 weeks, did you miss any of your injections? answer choices were given as none missed, miss 1 injection, or miss 2 injections. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||participants|||Number
1392729|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement I am satisfied with the dosing frequency (2 times per month) of this medication answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392730|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This medication improves my self-confidence and self-reliance, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392731|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing enables me to be more spontaneous and flexible, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392732|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing makes it more convenient for me to travel/vacation, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392733|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This medication makes it easy for me to carry out my daily responsibilities (ie, going to work, doing household chores or caring for my family), answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392734|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the statement This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392735|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How likely would you be to continue to use this medication? answers were numerically rated from 1 (extremely unlikely) to 10 (extremely likely). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392736|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How satisfied or dissatisfied are you with the injection frequency (every 2 weeks)? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392737|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question Overall, how satisfied or dissatisfied are you with this medication? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392738|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication every 2 weeks? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392739|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication as instructed? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392740|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant’s perception of treatment satisfaction at the end of each year of treatment. For the question How tolerable or intolerable do you find the medication? answers were numerically rated from 1 (extremely intolerable) to 10 (extremely tolerable). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392741|NCT01332019|Secondary|Number of MS-Related Hospitalizations|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment|||hospitalizations|||Number
1392742|NCT01332019|Secondary|Number of Relapses Requiring IV Steroid Use|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment|||relapses|||Number
1392743|NCT01332019|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392744|NCT01332019|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D) Index Score|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores of 1, 2, or 3 are possible responses for each of 5 questions (1=no problems, 2=some problems, 3=severe problems). A scoring formula developed by the EuroQol Group is then used to assign utility values for each participant’s Health State Profile. A summary index score (EQ-5D index score) is derived from the 5 questions by conversion with this scoring formula and a table of scores. EQ-5D Summary Index values ranged from -0.6 (worst health state) to 1.00 (perfect health state). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392745|NCT01332019|Secondary|Change From Baseline in SF-12 Physical Component Score (PCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. PCS was computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392746|NCT01332019|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. MCS computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392758|NCT01332019|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The total number of new or newly enlarging T2 hyperintense lesions (from Study 105MS302 Baseline) as assessed by magnetic resonance imaging (MRI). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
1392747|NCT01332019|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score|The 29-item MSIS-29 is a disease-specific participant-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures 20 physical items and 9 psychological items. Responses use a 5-point Likert scale ranging from 1 to 5. All questions are to be answered. The physical well being assessment portion of the MSIS-29 consists of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392748|NCT01332019|Secondary|Change From Baseline in Symbol Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 (worst) to 110 (best).|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392749|NCT01332019|Secondary|Time to Sustained Disability Progression|Estimated proportion of participants with progression and time to progression based on the Kaplan-Meier product limit method. Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from 105MS302 baseline EDSS ≥ 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from 105MS302 baseline EDSS = 0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Participants were censored at the time of withdrawal/switch/A3 effective date if they withdrew from study, switched to alternative MS medication, or Amendment 3 took effect without a progression.|Weeks 12, 24, 28, 72, 96, 120, 144, 168|Participants in the ITT population (all participants who were assigned a treatment and received at least 1 dose of study treatment) with disability progression.|||proportion of participants|||Number
1392750|NCT01332019|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS). The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
1392751|NCT01332019|Secondary|Percentage Change of Whole Brain Volume|Percentage change of whole brain volume as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||percentage change||Standard Deviation|Mean
1392752|NCT01332019|Secondary|Volume of Gd-Enhancing Lesions|The volume of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||cm^3||Standard Deviation|Mean
1392753|NCT01332019|Secondary|Volume of T1 Hypointense Lesions|The volume of T1 hypointense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||cm^3||Standard Deviation|Mean
1392754|NCT01332019|Secondary|Volume of T2 Hyperintense Lesions|The volume of T2 hyperintense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||cm^3||Standard Deviation|Mean
1392755|NCT01332019|Secondary|Number of Gd-Enhancing Lesions|The number of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
1392756|NCT01332019|Secondary|Number of New T1 Hypointense Lesions|The total number of new T1 hypointense lesions as assessed by MRI.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
1392757|NCT01332019|Secondary|Number of New Active Lesions|The number of new active lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
1392770|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death|Percentage of patients reporting Individual component of primary endpoint: cardiovascular death|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of patients|||Number
1392759|NCT01332019|Secondary|Percentage of Participants Who Relapsed|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. New or recurrent neurologic symptoms that occur less than 30 days following the onset of a relapse were considered part of the same relapse. Participants who did not experience a relapse prior to switching to alternative MS medications, withdrew from study, or Amendment 3 (A3) took effect were censored at the time of switch/withdrawal/A3 effective date.|Up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.|||percentage of participants|||Number
1392760|NCT01332019|Secondary|Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of person-years followed in the period.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.|||relapses per person-years|Relapses|95% Confidence Interval|Number
1392761|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Urinalysis|Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low or high/positive and who had at least 1 post-baseline value.|||participants|||Number
1392762|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. TSH=thyroid stimulating hormone.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
1392763|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Liver Function Laboratory Values|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
1392764|NCT01332019|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug and at least 1 post-baseline value for given parameter.|||participants|||Number
1392765|NCT01332019|Primary|Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded.|||participants|||Number
1392766|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality|Percentage of patients reporting Individual component of primary endpoint: All-cause mortality|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Percentage of patients|||Number
1392767|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: All-cause Mortality|Prospective comparison of time to first occurrence of Individual component of primary endpoint: All-cause mortality|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Months||95% Confidence Interval|Median
1392768|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke||From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of patients|||Number
1392769|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Stroke|Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal stroke|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
1395939|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence Before the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the nondominant hand before the procedure|Before the procedure (Baseline)||||participants|||Number
1392774|NCT01331837|Secondary|Percentages of Participants With an Expanded CV Composite Endpoint|Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Percentages of participants|||Number
1392775|NCT01331837|Secondary|The Time to First Occurrence of an Expanded CV Composite Endpoint|Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Months||95% Confidence Interval|Median
1392776|NCT01331837|Primary|Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date|Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).|From Baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of participants with event|||Number
1392777|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).|From Baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
1392778|NCT01331837|Primary|Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis|Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of patients with event|||Number
1392779|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis|Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
1392780|NCT01331837|Primary|Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis|Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis|From Baseline up to 4.9 years|Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.|||Percentage of patients with event|||Number
1392781|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event - Sensitivity Analysis|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis|From Baseline up to 4.9 years|Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.|||Months||95% Confidence Interval|Median
1392782|NCT01331837|Primary|Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event|Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke|From baseline up to 4.9 years|Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication|||Percentage of patients with event|||Number
1392783|NCT01331837|Primary|Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.|From baseline up to 4.9 years|Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication|||Months||95% Confidence Interval|Median
1392784|NCT01331824|Secondary|Safety as Measured by the Frequency and Type of Adverse Events as Per the Common Terminology for Adverse Events (CTCAE) Version 4.0.|Types of adverse events listed in Adverse Event Section|Day 1 of each treatment cycle; and 21 days after the last dose of amrubicin||||adverse events|||Number
1392785|NCT01331824|Secondary|Overall Survival|The median overall survival|1 year||||months||95% Confidence Interval|Median
1392786|NCT01331824|Secondary|Progression-free Survival|"The median progression-free survival~After the last dose of Amrubicin, patients will have follow-up every 3 months with a repeat CT scan of the chest, abdomen, and pelvis until the time of disease progression is documented."|Every 3 months post Amrubicin administration||||months||95% Confidence Interval|Median
1392787|NCT01331824|Primary|Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|"Response to treatment based on tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|6 weeks||||percentage of participants||95% Confidence Interval|Number
1392812|NCT01331161|Secondary|The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX|The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX|2 years|Participants with both T and B cell responses to vaccine|||participants|||Number
1392899|NCT01330316|Primary|Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL|The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
1392788|NCT01331694|Secondary|Average Annual Adjusted Post-Index COPD-Related Costs|Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists [LABA], inhaled corticosteroids [ICS], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.|Incurred over the 12 month period after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States|||United States dollars||Standard Deviation|Mean
1392789|NCT01331694|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Event|The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.|Anytime from 30 days to 12 months after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States.|||days||Standard Error|Mean
1392790|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1392791|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1392792|NCT01331681|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||micrometer||Standard Deviation|Mean
1392793|NCT01331681|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||Percentage of participants|||Number
1392794|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.|||Percentage of participants|||Number
1392795|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.|||Percentage of participants|||Number
1392796|NCT01331681|Primary|Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA.|||Letters correctly read||Standard Deviation|Mean
1392797|NCT01331304|Secondary|Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships. Summary scores can range from 4 to 20, with higher scores indicating greater functional impairment.|Average baseline score minus Average 6-month score||||units on a scale||95% Confidence Interval|Mean
1392798|NCT01331304|Secondary|Risk of Cardiovascular Disease - Framingham Risk Score|The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD), with higher scores indicating higher risk. Established benchmarks exist for scores from 0 to 25--though it can exceed this value--that are meant to translate to the probability of developing heart disease.|Average baseline score minus Average 6 month score||||units on a scale||95% Confidence Interval|Mean
1392799|NCT01331304|Primary|Necessary Clinical Adjustments|Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations.|6 Months||||Mean NCAs per month||Standard Deviation|Mean
1392800|NCT01331304|Primary|Clinical Global Impression-Efficacy Index (CGI-EI)|The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score.|Average 6 month score minus Average baseline score||||Units on the scale||95% Confidence Interval|Mean
1392801|NCT01331291|Secondary|Anti-tumor Response|Assess anti-tumor response in patients in Arm B using MacDonald criteria. There are four possible responses: complete response, partial response, stable disease, or progressive disease. Criteria are based on measurements of tumor dimension as visualized with a contrast-enhanced MRI.|2 years|Only Arm B participants were evaluable for this outcome measure|||participants|||Number
1392802|NCT01331291|Secondary|Safety Profile|Overall safety profile will be characterized by type, frequency, severity (as graded by NCI CTCAE), timing and relationship of study therapy of adverse events and laboratory abnormalities. Safety and tolerability will be measured by the proportion of patients who experience Grade 3 or higher Adverse Events that are possibly, probably or definitely related to bosutinib and the number of same Adverse Events per patient. Adverse Events will be summarized by treatment for each arm by the frequency of patients experiencing treatment emergent adverse events.|2 years||||participants|||Number
1392803|NCT01331291|Secondary|Intratumoral Concentration|Assess the intratumoral concentration of bosutinib in recurrent glioblastoma patients who are candidates for surgical re-resection (ARM A).|2 years|Participants in Arm B were never eligible for this outcome measure. Because only two participants were enrolled to Arm A, this analysis was not done as there were not sufficient tumor samples to generate meaningful results.||||||
1392804|NCT01331291|Primary|Progression-Free Survival|Assess progression-free survival at six months in patients with recurrent glioblastoma at first or second recurrence who are treated with continuous daily dosing of bosutinib (Arm B). Progression-free survival is measured from initiation of study treatment to date of progression.|2 years|This outcome was only applicable to participants enrolled on Arm B.|||weeks||95% Confidence Interval|Median
1392805|NCT01331213|Secondary|Post-treatment Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
1392806|NCT01331213|Secondary|Colonic Motility Index|The postprandial motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1] A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostatically-controlled balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|Approximately 1 hour after meal||||log mm Hg||Standard Deviation|Mean
1392807|NCT01331213|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|Approximately 60 minutes after drug administration||||mL||Standard Deviation|Mean
1392808|NCT01331213|Primary|Overall Sensory Ratings in Response to 16, 24, 30 and 36 mm Hg Distensions.|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
1392809|NCT01331213|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
1392810|NCT01331213|Primary|Postprandial Colonic Tone [Reported as the Symmetric Percent [Change} in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)||||Symmetric percentage change||Standard Deviation|Mean
1392811|NCT01331213|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|baseline (1 hour before drug administration), post-treatment (1 hour after drug administration)||||mm Hg||Standard Deviation|Mean
1392826|NCT01331005|Secondary|Corneal Melting||Baseline to 12 months|||||||
1392827|NCT01331005|Secondary|Corneal Ulceration||Baseline to 12 months|||||||
1392813|NCT01331161|Primary|Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX|The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX|2 years|participants with immunoglobulin gene responses that correlated with adaptive immune responses|||participants|||Number
1392814|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:~Preparatory acts or behavior~Aborted attempt~Interrupted attempt~Actual attempt~Completed suicide attempt"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
1392815|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
1392816|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
1392817|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
1392818|NCT01331109|Primary|Adverse Events|Number of Patients who experience one or more treatment emergent adverse event (TEAE)|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
1392819|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
1392820|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
1392821|NCT01331005|Secondary|Change in Level of Diabetic Retinopathy on Stereoscopic Fundus Photographs|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|Baseline to 12 months|||||||
1392822|NCT01331005|Secondary|Change in Number of Thickened Subfields on OCT|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|Baseline to 12 months|||||||
1392823|NCT01331005|Secondary|Change in OCT Central Subfield Thickness|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months|||||||
1392824|NCT01331005|Secondary|Mean Change in Visual Acuity|The 95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for diabetic macular edema(DME) before 1 year, visual acuity and optical coherence tomography (OCT) measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months|||||||
1392825|NCT01331005|Secondary|Irritation||Baseline to 12 months|||||||
1392830|NCT01330953|Secondary|Change From Baseline in Serum Iron|Maximum change from baseline to any point over 22 days post-infusion.|Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided plasma data for measuring serum iron levels as the primary pharmacodynamic analysis.|||microgram per deciliter (µg/dL)||Standard Deviation|Mean
1392831|NCT01330953|Secondary|Pharmacokinetics, Terminal Half-Life (t1/2)||Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic t1/2 analyses.|||days||Full Range|Geometric Mean
1392832|NCT01330953|Secondary|Pharmacokinetics, Volume of Distribution (V)|V=LY2928057 steady-state volume of distribution (Vss)|Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Vss analyses.|||L||Geometric Coefficient of Variation|Geometric Mean
1392833|NCT01330953|Secondary|Pharmacokinetics, Systemic Clearance (CL)|CL=total body clearance of LY2928057 calculated after intravenous administration. Systemic CL was derived from LY2928057 serum concentration data following intravenous administration using classical non compartmental analysis (WinNonlin version 5.3).|Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic systemic CL analyses.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1392834|NCT01330953|Secondary|Pharmacokinetics, Time to Maximum Concentration (Tmax)||Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic tmax analyses.|||hour (h)||Full Range|Median
1392835|NCT01330953|Secondary|Pharmacokinetics, Maximum Concentration (Cmax)||Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Cmax analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1392836|NCT01330953|Secondary|Pharmacokinetics, Area Under the Curve (AUC)|Area under the LY2928057 plasma concentration-time curve extrapolated to infinite time (AUC0-∞).|Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic AUC analyses.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1392837|NCT01330953|Primary|Number of Participants With Clinically Significant Adverse Effects|A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module.|Baseline through Day 85|The analysis population included all randomized participants dosed with placebo or LY2928057, and who provided safety data at least up to and including the Day 8 assessment.|||participants|||Number
1392838|NCT01330914|Secondary|Bone Structure|Trabecular and cortical bone microstructure by HR-pQCT|pre-operatively and 6 and 12 months post-operatively|||||||
1392839|NCT01330914|Secondary|Bone Mineral Density (BMD, Areal and Volumetric)|Areal BMD at the spine, proximal femur, and forearm by dual-energy X-ray absorptiometry (DXA); volumetric BMD at the spine and hip by quantitative computed tomography (QCT); volumetric BMD at the ultradistal radius and ultradistal tibia by high-resolution peripheral QCT (HR-pQCT)|pre-operatively and 6 and 12 months post-operatively|||||||
1392840|NCT01330914|Primary|Change in Intestinal Calcium Absorption|"Change in fractional calcium absorption, determined by dual stable isotope method.~Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%."|6 months|Participants from the cohort who underwent assessment of fractional calcium absorption preoperatively and 6 months postoperatively|||% of ingested calcium that is absorbed||Standard Deviation|Mean
1392841|NCT01330628|Primary|Freedom From Major Adverse Events (MAE)|Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).|30 days|The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis.|||# of participants free from MAE|||Number
1392842|NCT01330628|Primary|Freedom From Target Lesion Revascularization (TLR)|Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.|6 months|The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis.|||# of participants free from TLR|||Number
1392843|NCT01330433|Secondary|Hospital Stay|Number of days post surgery.|Length of stay after second surgery up to 1 month|The difference in the number of participants analyzed and the total number of participants is due to feeding issues unrelated to the surgery or the device that required the subject to remain hospitalized longer than anticipated.|||days||Standard Deviation|Mean
1392844|NCT01330433|Primary|Adhesion Burden|Skin to bypass time as an indicator of adhesion burden.|Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)||||minutes||Standard Deviation|Mean
1392900|NCT01330303|Primary|Cmax|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
1392845|NCT01330433|Primary|Post-operative Bleeding|Post-operative bleeding through surgical site drainage output.|Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery|The difference in the number of participants analyzed and the total number of participants is due to the information not being properly collected at the time of the surgery. Because there was a lack of confidence in the data, it was discarded.|||cm^3||Standard Deviation|Mean
1392846|NCT01330433|Primary|Severity of Adhesions at the Right Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
1392847|NCT01330433|Primary|Severity of Adhesions at the Left Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
1392848|NCT01330433|Primary|Severity of Adhesions at the Diaphragm Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
1392849|NCT01330433|Primary|Severity of Adhesions at the Arterial Base Site.|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
1392850|NCT01330433|Primary|Severity of Adhesions at the Retrosternal Site|Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
1392851|NCT01330420|Secondary|The Health Promoting Lifestyle Profile II (HPLP-II)|"The Health Promoting Lifestyle Profile II (HPLP-II) was used to assess health promoting behaviors. Based on the Health Promoting Model (Pender, 1982) this 52-item instrument measures self-initiated health behaviors that serve to maintain or enhance the level of self-actualization and wellness. Included are subscales for physical activity, spiritual growth, health responsibility, interpersonal relations, nutrition, and stress management. It is self-administered and uses a 4-point response format. Both English and Spanish versions are available.~A score for overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items; six subscale scores are obtained similarly by calculating a mean of the responses to subscale items. Scores range from 1 = Never to 4 = Routinely, with a higher score corresponding to a more health promoting lifestyle."|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.|||units on a scale||Standard Deviation|Mean
1392852|NCT01330420|Primary|Satisfaction With Care (PSQ-18)|Patient Satisfaction Questionnaire Short Form (PSQ-18) takes approximately 3-4 minutes to complete, containing 18 items examining seven dimensions of satisfaction with medical care: general satisfaction (2 questions, Mean =3.58, SD =0.94), technical quality (3 questions, Mean = 3.68, SD = 0.76), interpersonal manner (2 questions, Mean = 4.09, SD = 0.69), communication (2 questions, Mean = 3.74, SD = 0.87), financial aspects (2 questions, Mean = 3.78, SD = 0.94), time spent with doctor (2 questions, Mean = 3.59, SD = 0.94), and accessibility and convenience (4 questions, Mean = 3.76, SD = 0.74). Responses to each item are given on a 5-point scale ranging from 1 - strongly agree to 5 - strong disagree, therefore higher scores correspond to less satisfaction. PSQ-18 subscale scores are substantially correlated with their full-scale counterparts and possess generally adequate internal consistency reliability.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.|||units on a scale||Standard Deviation|Mean
1392853|NCT01330420|Primary|Quality of Life (QOL-5)|The QOL-5 is a short, global, and generic quality of life (QoL) questionnaire for clinical databases. The QOL-5 item tool is used to compare various population groups using generic factors common to people everywhere irrespective of age, sex, culture, and state of health. Scores on the QOL-5 ranges from 0 = lowest quality to 100 = highest quality.|comparison pre program initiation and post program completion time points (6 weeks)||||units on a scale||Standard Deviation|Mean
1392854|NCT01330420|Primary|Health Status (SF-12)|The SF-12 was used to assess health status. It is the shortened version of the well-validated SF-36, directed at monitoring overall physical and mental health outcomes. It is available in both English and Spanish. Scoring algorithms involve weighted-item responses, all 8 scales to use the same standardization for easy comparison. All scores range from 0–100 where higher scores indicated better QOL. The mean = 50 and the SD = 10.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.|||units on a scale||Standard Deviation|Mean
1392855|NCT01330420|Primary|Depression Severity (CEDS-10)|The Center for Epidemiologic Studies Depression Scale (CES-D 10) was used to assess depression severity pre-and post-intervention. This is the shorter 10-item, modified version of the 20-item CES-D. The total score is the sum of the 10 item weights, with the lowest possible score being 0 and the highest possible score being 30, and a higher score indicating more depressive symptoms. Developed from other well-validated depression scales, this instrument measures the experience of depressive symptoms over the past week. This instrument is shown to be better than the CES-D 20 in combining data from different ethnic and cultural groups, and is available in both English and Spanish. This scale has been reported to have good internal consistency and validity.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions.|||units on a scale||Standard Deviation|Mean
1392856|NCT01330394|Secondary|Effort to Control the Urge for Use Alcohol|Obsessive Compulsive Drinking Scale will be applied before and after ERP procedures|one year and a half|||||||
1392857|NCT01330394|Secondary|Quality of Life|Quality of life scale will be applied at the end of the protocol|one year and a half|||||||
1392858|NCT01330394|Secondary|Cognitive Tasks|Cognitive tests comprised by Frontal Assessment Battery (FAB), verbal n-back task, visuospatial n-back task, go-no-go task, counting Stroop, will be done at the beginning of the session 1 and session 6 (one week after the 5 sessions of sham or tDCS).|one year and a half|||||||
1392859|NCT01330394|Secondary|Event-related Potentials|Event-related potential (ERPs) was recorded under the presentation of 120 sounds [60 of 3 types related to the use of alcoholic beverages (open a can of beer, fill a glass of beer, opening and fall of the lid of a bottle of beer), and 3 types of 60 neutral sounds (open a door, typing a keyboard, shower water)] lasted for 384 s for each period before and after transcranial Direct Current Stimulation|one year and a half|||||||
1392860|NCT01330394|Primary|Use of Alcohol|Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).|6 months after treatment||||participants|||Number
1392861|NCT01330381|Secondary|Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
1392862|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
1392863|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
1392864|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
1392865|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
1392866|NCT01330381|Secondary|Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period||Baseline and over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||SBM/week||Standard Deviation|Mean
1392867|NCT01330381|Secondary|Number of SBM Per Week in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||SBM/week||Standard Deviation|Mean
1392868|NCT01330381|Secondary|Time to First SBM in the Double-Blind Treatment Period|After intake of the trial medication on Day 1.|Day 1 onwards|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.|||hours||95% Confidence Interval|Median
1392869|NCT01330381|Secondary|Number of Rescue Medications Taken in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||rescue medications/week||Standard Deviation|Mean
1392870|NCT01330381|Secondary|Frequency of Toilet Training in the Double-Blind Treatment Period|Only for subjects after acquisition of toileting skills.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||toilet trainings/week||Standard Deviation|Mean
1392871|NCT01330381|Secondary|Abdominal Pain Score in Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
1392872|NCT01330381|Secondary|Large Diameter Stools in the Double-Blind Treatment Period|Large diameter stools make defecation more difficult. Small diameter stools are better.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||large diameter stools/week||Standard Deviation|Mean
1392873|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period|Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
1392874|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period|Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
1392875|NCT01330381|Secondary|Painful Bowel Movements Score in the Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
1392876|NCT01330381|Secondary|Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period|Purposefully avoiding defecation.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||retentions/week||Standard Deviation|Mean
1392877|NCT01330381|Secondary|Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period|Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
1392878|NCT01330381|Secondary|Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.|||percentage of subjects|||Number
1392879|NCT01330381|Primary|Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period|Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.|||percentage of subjects|||Number
1392880|NCT01330355|Secondary|Microbial Outcome|"Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:~over all bacterial species~over all and individual gram-positive bacterial species~over all and individual gram-negative bacterial species"|Visit 3 (Day 3) and Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species).|||events|||Number
1392881|NCT01330355|Secondary|Microbial Eradication|Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||participants|||Number
1392882|NCT01330355|Secondary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 3 (Day 3)|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||participants|||Number
1392883|NCT01330355|Primary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||participants|||Number
1392884|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure Bilirubin total is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||milligram (mg)/dL||Standard Deviation|Mean
1392944|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 12|ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.|Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.|||percentage of participants|||Number
1392885|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [AST]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure AST is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||U/L||Standard Deviation|Mean
1392886|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [ALT]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure ALT is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||Units (U)/Litre (L)||Standard Deviation|Mean
1392887|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure Haemoglobin is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||gram (g)/decilitre (dL)||Standard Deviation|Mean
1392888|NCT01330316|Secondary|Laboratory Test Abnormalities by DAIDS Grades|This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.|baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study|FAS|||percentage of participants|||Number
1392889|NCT01330316|Secondary|Occurrence of Drug-related AEs as Assessed by the Investigator|This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
1392890|NCT01330316|Secondary|Occurrence of Serious Adverse Events (SAEs)|This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
1392891|NCT01330316|Secondary|Occurrence of Adverse Events Leading to Treatment Discontinuation|This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
1392892|NCT01330316|Secondary|Occurrence of Adverse Events (Overall and by DAIDS Grade)|"This outcome measure will be presented as the percentage of subjects with any adverse event (AE).~Percentages are calculated using total number of subjects per treatment cohort as the denominator.~The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment."|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
1392893|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS|||participants|||Number
1392894|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.|FAS|||participants|||Number
1392895|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS|FAS|||participants|||Number
1392896|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS|||participants|||Number
1392897|NCT01330316|Secondary|Early Treatment Success (ETS)|ETS, defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|FAS|||percentage of participants|||Number
1392898|NCT01330316|Secondary|Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
1392945|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 24||Week 24|Participants in the Safety Analysis Set with Available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.|||percentage of participants|||Number
1392901|NCT01330303|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
1392902|NCT01330303|Primary|AUC 0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study|||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
1392903|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392904|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392905|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392906|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392907|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392908|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392909|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392910|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392911|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392912|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392913|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392946|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 12||Week 12|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
1392914|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392915|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392916|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392917|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392918|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392919|NCT01330290|Secondary|Score for the Physicians’ Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392947|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 8||Week 8|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
1392920|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.|||participants|||Number
1392921|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.|||participants|||Number
1392922|NCT01330290|Primary|Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392923|NCT01330290|Primary|Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
1392924|NCT01330134|Secondary|Pain Assessment: During Procedure|visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection.|post procedure (day 1)||||units on a scale||Standard Deviation|Mean
1392925|NCT01330134|Secondary|Pain Assessment: Lidocaine Injection|visual analog scale (VAS) 0= no pain to 100 = worse pain possible|post procedure (day 1)||||units on a scale||Standard Deviation|Mean
1392926|NCT01330134|Primary|Pain Assessment: Overall|Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome.|post procedure (day 1)||||units on a scale||Standard Deviation|Mean
1392927|NCT01330108|Secondary|Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan|Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was.|baseline to 12 weeks||||meters||Full Range|Mean
1392928|NCT01330108|Primary|Number of Subjects Not Able to Tolerate Ambrisentan|If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject.|baseline to 12 weeks||||participants|||Number
1392929|NCT01330043|Secondary|Expired-air CO Verified Point-prevalence Abstinence|Self-reported no smoking in last 7 days verified by CO<10 ppm|104 weeks||||participants|||Number
1392930|NCT01330043|Primary|Expired-air CO Verified Point-prevalence Abstinence|Self-reported no smoking in last 7 days verified by CO<10 ppm|52 weeks||||participants|||Number
1392931|NCT01330030|Primary|Expired-air Carbon Monoxide Confirmed Smoking Abstinence|expired-air carbon monoxide confirmed smoking abstinence at 52 weeks|52 weeks|intention to treat|||participants not smoking|||Number
1392932|NCT01330017|Secondary|Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7|The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline, Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
1392948|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 4||Week 4|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
1392933|NCT01330017|Secondary|Time to Maximal Effect|Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.|Baseline up to Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Days|||Number
1392934|NCT01330017|Secondary|Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the~morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
1392935|NCT01330017|Secondary|Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
1392936|NCT01330017|Secondary|Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the~morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Day 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
1392937|NCT01330017|Secondary|Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
1392938|NCT01330017|Secondary|Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
1392939|NCT01330017|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.|Baseline, Day 7|The Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
1392940|NCT01329978|Secondary|Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).|Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.|End of treatment to Post-treatment Week 24|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
1392941|NCT01329978|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either~HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or~HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)~Baseline was Day 1 for all groups."|Baseline (Day 1) to Week 24|Safety Analysis Set|||percentage of participants|||Number
1392942|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Post-treatment Week 4|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.|Baseline (Day 1) to Post-treatment Week 4|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.|||percentage of participants|||Number
1392943|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 24|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.|Baseline (Day 1) to Week 24|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.|||percentage of participants|||Number
1392954|NCT01329978|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.|Post-treatment Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1392955|NCT01329978|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline (Day 1) to post-treatment Day 30|Safety Analysis Set|||percentage of participants|||Number
1392956|NCT01329978|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)|SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Week 24|Participants in the Safety Analysis Set (participants who were randomized and received at least 1 dose of study drug) with genotype 1 and who had available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
1392957|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio|The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.|||pg/mg||95% Confidence Interval|Mean
1392958|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels|Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.|||mg/mL||95% Confidence Interval|Mean
1392959|NCT01329939|Secondary|Beclomethasone Equivalents|The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||micrograms||95% Confidence Interval|Mean
1392960|NCT01329939|Secondary|Exhaled Nitric Oxide Measurement|A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||ppb||95% Confidence Interval|Mean
1392961|NCT01329939|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.|||pg/mL||95% Confidence Interval|Mean
1392962|NCT01329939|Secondary|Serum Leptin Levels|Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage.|24 weeks||||ng/mL||95% Confidence Interval|Mean
1392963|NCT01329939|Secondary|Spirometric Measures|Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||percent predicted||95% Confidence Interval|Mean
1392964|NCT01329939|Primary|Asthma Control Test (ACT) Scores|The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||units on a scale||95% Confidence Interval|Mean
1392965|NCT01329848|Secondary|Conlon Symptom Survey|Measures visual discomfort symptoms while doing near work. 23 item survey using a 4-point rating scale (never, occasionally, often, almost always). Total raw score reported on a range from 0 to 69 with higher scores indicating more frequent symptoms.|3 weeks||||units on a scale||Standard Deviation|Mean
1392966|NCT01329848|Primary|Accommodation Lag 5D|Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.|3 week period||||diopters||Standard Deviation|Mean
1392967|NCT01329679|Secondary|Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
1392968|NCT01329679|Secondary|Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
1392969|NCT01329679|Secondary|Max QRS Duration After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
1392970|NCT01329679|Secondary|Max PR-interval After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
1392971|NCT01329679|Secondary|Max Heart Rate After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption||||beats per minute||Standard Deviation|Mean
1392972|NCT01329679|Secondary|Office DBP After a Single Energy Shot and After Chronic Consumption|Office diastolic blood pressure (DBP)|At baseline and 7 days post energy drink and placebo consumption||||mmHg||Standard Deviation|Mean
1392974|NCT01329562|Secondary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders|"Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From mid luteal phase and for the duration of 1 menstrual migraine until headache free.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
1392975|NCT01329562|Secondary|α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline from 24 hours post migraine gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||U/L||Standard Deviation|Mean
1392976|NCT01329562|Secondary|CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline to 24 hours post headache gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pmol/mg||Standard Deviation|Mean
1392977|NCT01329562|Secondary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria."|From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
1392978|NCT01329562|Primary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.|"Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point."|From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
1392979|NCT01329562|Primary|α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.|||U/L||Standard Deviation|Mean
1392980|NCT01329562|Primary|CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.|||pmol/mg||Standard Deviation|Mean
1392981|NCT01329562|Primary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache.|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.|||pg/mL||Standard Deviation|Mean
1392982|NCT01329562|Secondary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||U/L||Standard Deviation|Mean
1392983|NCT01329562|Secondary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pmol/mg||Standard Deviation|Mean
1392984|NCT01329562|Secondary|Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
1392985|NCT01329562|Secondary|Time to Pain-Free in Responders vs Non-Responders|"Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.~0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine headache until pain-free.||||hours||Standard Deviation|Mean
1392986|NCT01329562|Secondary|Migraine Recurrence Responders vs Non-Responders|"Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.~0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine until 24 hours post treatment.||||participants|||Number
1392987|NCT01329562|Primary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||U/L||Standard Deviation|Mean
1392988|NCT01329562|Primary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pmol/mg||Standard Deviation|Mean
1392989|NCT01329562|Primary|Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
1393011|NCT01329029|Secondary|Change From Baseline in Body Weight|Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF).|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.|||kilogram (kg)||Standard Error|Least Squares Mean
1392990|NCT01329562|Primary|Time to Pain Free|"Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe."|From onset of 1 menstrual migraine headache until pain free.|In Group B, one subject did not report when their headache resolve, therefore a duration for this subject could not be calculated.|||hours||Standard Deviation|Mean
1392991|NCT01329562|Primary|Migraine Recurrence|"Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe."|From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.||||participants|||Number
1392992|NCT01329549|Secondary|Apparent Volume of Distribution at Steady State (Vss)|"Vss was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
1392993|NCT01329549|Secondary|Total Plasma Clearance (CL)|"CL was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
1392994|NCT01329549|Secondary|Terminal Half-life (t1/2)|"t1/2 was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
1392995|NCT01329549|Secondary|Time From Dosing to the Maximum Plasma Concentration (Tmax)|"tmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
1392996|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
1392997|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)|"AUC0-tz was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
1393012|NCT01329029|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|52 Weeks|Safety Population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
1392998|NCT01329549|Secondary|Maximum Measured Plasma Concentration (Cmax)|"Cmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). This endpoint has not been statistically analyzed in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
1392999|NCT01329549|Primary|Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib|to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.|28 days|Treated set||||||
1393000|NCT01329419|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|12 weeks|ITT Population|||participants|||Number
1393001|NCT01329419|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|12 weeks|ITT Population|||participants|||Number
1393002|NCT01329419|Primary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|12 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments|||participants|||Number
1393003|NCT01329263|Primary|Subjective Rating of Cigarettes|Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.|Immediately after a cigarette smoked at the study session|Completed measure|||units on a scale||Standard Error|Mean
1393004|NCT01329263|Primary|Nicotine Levels|Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.|35 days|Those completing Day 5, returning sample for assay|||micrograms/mL||Standard Error|Mean
1393005|NCT01329263|Primary|Smoking Topography- Carbon Monoxide Boost|Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.|Measured before and after each cigarette smoked at study sessions||||parts per million||Standard Error|Mean
1393006|NCT01329263|Primary|Smoking Topography- Puff Volume|The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.|over 35 day study period|Those completing Study session 2 at Day 5.|||mL||Standard Error|Mean
1393007|NCT01329198|Secondary|Correlation of Tics and Neural Physiology|Electrical recordings of electroencephalography activity were taken from each subject's implanted leads at each visit from baseline to 6 months. At baseline, the recordings were taken with the device in the off state (not stimulating), while at the 6 month visits the recordings were taken with the subject's device set to optimal parameters for tic control. Using Pearson's correlation coefficient, the variations in frequency and power which were observed were correlated with the Yale Global Tic Severity (YGTSS) scores obtained during primary outcome testing.|Baseline to 6 Months||||Pearson Correlation Coefficient|||Number
1393008|NCT01329198|Primary|Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented|"The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are:~Total Motor Tic Score (0-25)~Total Phonic Tic Score (0-25~Total Tic Score (0-50)~Overall Impairment Rating (0-50)~Global Severity Score (0-7)~The YGTSS Total Score is obtained by adding the Total Tic Score to the Overall Impairment Rating. The efficacy of the intervention will be assessed by comparing each subject's 6-month YGTSS Total Score to the pre-operative value for the same patient. Efficacy is considered 50% or greater reduction in this score."|Baseline to 6 Months||||units on a scale||95% Confidence Interval|Mean
1393009|NCT01329185|Primary|Incidence of EBV or CMV Related Disease in Transplant Recipient|Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.|At least 1 year||||participants|||Number
1393010|NCT01329029|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF.|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.|||kg/m^2||Standard Error|Least Squares Mean
1393013|NCT01329029|Secondary|Time to Trial Withdrawal Due to an Adverse Event|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.|||days||Full Range|Median
1393014|NCT01329029|Secondary|Time to First Hospitalisation Due to Any Cause During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.|||days||95% Confidence Interval|Median
1393015|NCT01329029|Secondary|Percentage of Participant With All-Cause Hospitalisation During the Treatment Period|Percentage of patients with at least one hospital admission due to any cause.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
1393016|NCT01329029|Secondary|Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
1393017|NCT01329029|Secondary|Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke).|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
1393018|NCT01329029|Secondary|Time to Withdrawal Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
1393019|NCT01329029|Secondary|Time to Withdrawal During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
1393020|NCT01329029|Secondary|Time to Mortality Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
1393021|NCT01329029|Secondary|Time to Mortality Due to Any Reason During the Treatment Period Score|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
1393022|NCT01329029|Secondary|Percentage of Participants With Improvement in CAT|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
1393023|NCT01329029|Secondary|Change From Baseline in COPD Assessment Test (CAT) Total Score|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||score on a scale||Standard Error|Mean
1393024|NCT01329029|Secondary|Percentage of Rescue Medication-Free Days|Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of days||Standard Deviation|Mean
1393025|NCT01329029|Secondary|Percentage of Symptom-Free Days|Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of days||Standard Deviation|Mean
1393104|NCT01328496|Secondary|Number of Observational Arm Patients Who Relapsed|The number of observational arm patients who relapsed was given.|1 year||||Participants|||Count of Participants
1393026|NCT01329029|Secondary|Change From Baseline in COPD Symptom Score From Daily Diary|Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome).|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
1393027|NCT01329029|Secondary|Change From Baseline in Use of Rescue Medication From Daily Diary|Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data included in the repeated measurements analysis.|||puffs per day||Standard Error|Least Squares Mean
1393028|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator FEV1/FVC|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percent||Standard Deviation|Mean
1393029|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters||Standard Error|Least Squares Mean
1393030|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%)|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters/second||Standard Error|Least Squares Mean
1393031|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters||Standard Error|Least Squares Mean
1393032|NCT01329029|Secondary|Duration of Moderate or Severe COPD Exacerbations Per Participant|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. n in each of the categories is the number of participants with exacerbations.|||days||Standard Deviation|Mean
1393033|NCT01329029|Secondary|Number of Moderate or Severe COPD Exacerbation Days|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation — start date of exacerbation + 1) of all exacerbations within the category.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||days||Standard Deviation|Mean
1393034|NCT01329029|Secondary|Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year|The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)— Rate (Roflumilast 500 μg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||participants|||Number
1393035|NCT01329029|Secondary|Time to Third Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
1393036|NCT01329029|Secondary|Time to Second Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||95% Confidence Interval|Median
1393037|NCT01329029|Secondary|Time to First COPD Exacerbation All Categories|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||95% Confidence Interval|Median
1393038|NCT01329029|Secondary|Percentage of Participants Experiencing at Least 1 COPD Exacerbation|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
1393039|NCT01329029|Secondary|Rate of COPD Exacerbations Per Patient Per Year All Categories|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
1393040|NCT01329029|Secondary|Rate of Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
1393041|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1)|Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters||Standard Error|Least Squares Mean
1393042|NCT01329029|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient’s baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
1393043|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||United States dollars||Standard Deviation|Mean
1393044|NCT01328964|Secondary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||Asthma related events per100 person year|||Number
1393045|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||United States dollars||Standard Deviation|Mean
1393046|NCT01328964|Primary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||asthma events per 100 person years|||Number
1393047|NCT01328951|Secondary|Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1393048|NCT01328951|Secondary|Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1393049|NCT01328951|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1393050|NCT01328951|Secondary|Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.|At 6 months|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1393051|NCT01328951|Secondary|Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||weeks||95% Confidence Interval|Median
1393052|NCT01328951|Secondary|Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment|Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants|||Number
1393053|NCT01328951|Primary|Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.|At 1 year|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1393054|NCT01328951|Primary|Overall Survival (OS) as Median Time to Event During the Overall Study|Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.|||months||95% Confidence Interval|Median
1393055|NCT01328951|Primary|Percentage of Participants Who Died During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.|||percentage of participants|||Number
1393056|NCT01328873|Secondary|Number of Participants With Positive Myocbacteria Results by Culture|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
1393057|NCT01328873|Secondary|Number of Participants With Positive Viral Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
1393058|NCT01328873|Secondary|Number of Patients With Positive Fungal Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
1393059|NCT01328873|Secondary|Number of Participants With Positive Bacterial Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
1393060|NCT01328873|Secondary|Number of Patients With Positive CT Result|"To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings. Patients were evaluated by changes on the CT and categorized as follows:~Air space~ground glass/reticular nodular~nodular/cavitary~single patchy infiltrate"|30 days||||participants|||Number
1393061|NCT01328873|Primary|Number of Patients With Positive Culture or Molecular Results After Brochoscopy|To determine the diagnostic yield related to fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in hematopoietic stem cell transplant (HSCT) and leukemia patients with acute respiratory symptoms and pulmonary infiltrates utilizing both current standard of care microbiology testing and emerging molecular genetic laboratory assessments.|30 days||||participants|||Number
1393062|NCT01328782|Secondary|Need for IV Morphine of Fentanyl|Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.|First 120 minutes after the end of surgery (surgery close time)|All subjects were included in the analysis.|||participants|||Number
1393063|NCT01328782|Secondary|Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge||Analgesic data collected during first four hours following the end of surgery (surgery close)|All subjects were included in the analysis.|||Morphine (po) equivalents [mg*kg-1]||Standard Deviation|Mean
1393064|NCT01328782|Secondary|Time (in Minutes) to First Narcotic Administration||first 72 hours after surgery close time|All subjects were included in the analysis.|||Minutes||Inter-Quartile Range|Median
1393065|NCT01328782|Secondary|Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child’s Current Level of Pain, Question # 17: Child’s Worst Level of Pain When Moving Around After Surgery and Question # 18: Child’s Worst Level of Pain While Resting|Total quality pain management survey is validated survey used to assess parents’ perceptions of their child’s pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain.|Will be obtained from parent(s) 120 minutes after arrival to the recovery room|Based on number of participants and their parents/legal guardians that completed the survey.|||Scores on a scale||Standard Deviation|Mean
1393066|NCT01328782|Primary|The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).|The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.|Will be obtained 30 - 60 minutes after arrival to the recovery room|Based on the number of participants that self-reported their pain score.|||Scores on a scale||Standard Deviation|Mean
1393067|NCT01328769|Secondary|Change in Endothelial Function|Endothelial function was calculated by software from the manufacturer VENDYS. The measurement was taken by using the index of area under the curve of the finger temperature recovery curve just after releasing a blood pressure cuff. The blood pressure cuff occluded blood flow for 5 minutes as compared to the temperature curve in the non-occluded arm.|Baseline to 6 weeks||||ratio of finger temperature||Standard Deviation|Mean
1393068|NCT01328769|Primary|Change in Renal Plasma Flow in Response to Infused Angiotensin II||Baseline to 6 weeks||||ml/minute||Standard Error|Mean
1393069|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.|LOTA (Week 104)|FAS population|||participants|||Number
1393070|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.|LOTA (Week 104)|FAS population|||participants|||Number
1393105|NCT01328496|Secondary|Number of Observational Arm Participants Engrafted|For patients enrolled in the observational arm (undergoing a double unit UCBT), the number of patients engrafted was given.|1 year||||Participants|||Count of Participants
1393071|NCT01328756|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)|ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.|Baseline (Week 0), LOTA (Week 104)|Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.|||Scores on a scale||Standard Deviation|Mean
1393072|NCT01328756|Primary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)|The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||scores on a scale||Standard Deviation|Mean
1393073|NCT01328756|Primary|Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||milliseconds||Standard Deviation|Mean
1393074|NCT01328756|Primary|Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||milliseconds||Standard Deviation|Mean
1393075|NCT01328756|Primary|Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||beats per minute||Standard Deviation|Mean
1393076|NCT01328756|Primary|Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)|BMI was calculated as (weight [kilogram] per height [square meter]).|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||kilogram per square meter||Standard Deviation|Mean
1393077|NCT01328756|Primary|Change From Baseline in Height at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||centimeter(s)||Standard Deviation|Mean
1393078|NCT01328756|Primary|Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||kilogram(s)||Standard Deviation|Mean
1393079|NCT01328756|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||mmHg||Standard Deviation|Mean
1393080|NCT01328756|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||mmHg||Standard Deviation|Mean
1393081|NCT01328756|Primary|Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||beats per minute||Standard Deviation|Mean
1393082|NCT01328756|Primary|Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant’s first dose of investigational product in this study and the 3 days following cessation of treatment.|Baseline up to 3 days after the last dose of study treatment (up to 2 years)|Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.|||participants|||Number
1393083|NCT01328717|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)|Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.|1 hour|Per protocol|||Number of Participants|||Number
1393084|NCT01328717|Primary|Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results.|1 hour|As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, one subject did not complete the study. The remaining 77 subjects tested 2 test strip lots on the system. 2x77(154) test results were available.|||Percentage of BG test results|Participants||Number
1393085|NCT01328574|Secondary|Incidence of TRC-105-Related Adverse Events|Adverse events by grade, (e.g. 1 is mild, 2 is moderate, 3 is severe and 4 is life threatening) related to TRC-105.|24 months||||participants|||Number
1393086|NCT01328574|Secondary|Median Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 25 months||||Months||95% Confidence Interval|Median
1393087|NCT01328574|Secondary|Objective Response|Objective response is defined as the number of participants who meet the criteria for a complete response (CR) or a partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 25 months||||participants|||Number
1393088|NCT01328574|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|24 months||||participants|||Number
1393089|NCT01328574|Primary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression).-|after 6 months on study||||Months||95% Confidence Interval|Median
1393090|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.|||% of peripheral blood mononuclear cell||Standard Deviation|Mean
1393091|NCT01328548|Other Pre-specified|Testing 150 Candidate Immune Response Genes for SNP Analysis|These will include Tolllike receptors, cytokines, chemokines, chemokine receptors, interferons and interferon receptors. Tolllike receptors: TLR1TLR9 Cytokines: ILI1A, ILI1B, IL1RN, IL4, IL5, IL12B, IL13, CSF2 Chemokines: CCL1CCL3, CCL3L1, CCL4CCL8, CCL11, CCL13, CCL15CCL28, CXCL1CXCL14, CXCL16, CX3CL1 Chemokine receptors: CCR1CCR10, CXCR1CXCR6, CX3CR1, XCR1XCR2 Interferons: IFNA1IFNA2, IFNA4IFNA8, IFNA10, IFNA13, IFNA14, IFNA16IFNA17, IFNA21, IFNB1, IFNB3, IFNG, IFNK, IFNW1 Interferon receptors: IFNAR1, IFNAR2, IFNGR1, IFNGR2|Baseline|Genotyping was not conducted because of insufficient resources.||||||
1393092|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells|Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.|Baseline|Data not collected.||||||
1393093|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells|Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.|Baseline|Data not collected.||||||
1393094|NCT01328548|Primary|Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.|||% of peripheral blood mononuclear cell||Standard Deviation|Mean
1393095|NCT01328548|Primary|Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.|||T-cell ratio||Standard Deviation|Mean
1393096|NCT01328548|Primary|Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly|As the primary phenotype, we will compare change in Enzyme-linked immunosorbent spot (ELISPOT) from baseline (i.e., pre and post vaccination). A high baseline T cell response will be defined as ELISPOT = >50 spots and a low baseline response will be ELISPOT = <10 spots.|6 weeks|IFN-gamma T cell ELISpot assay (sfu) against VZV taken prior to vaccination and 6 weeks post vaccination|||Spot Forming Units per 10^6 PBMC||Standard Deviation|Mean
1393097|NCT01328496|Secondary|The Number of Participants With Transplant-related Morbidity|Any patient who had adverse events listed either as probable or definite in the first 100 days post-transplant are counted as transplant related morbidity. The number of patients with transplant-related morbidity was given.|first 100 days post transplant||||Participants|||Count of Participants
1393098|NCT01328496|Secondary|Incidence of Transplant-related Mortality (TRM)|TRM is death occurring in patients in continuous complete remission. The numbers of patients with TRM was given.|first 100 days post transplant||||Participants|||Count of Participants
1393099|NCT01328496|Secondary|Time to Engraftment of Research Arm Participants|Platelet engraftment was defined as platelet count ≥20,000/mm^3 for 3 consecutive tests performed on different days with no platelet transfusions in the preceding 7 days. Neutrophil engraftment will be defined as achieving ANC ≥ 500/mm3 for 3 consecutive tests performed on different days with evidence of donor cell engraftment. Descriptive statistics are provided.|first 100 days post transplant|Those patients who did not reach engraftment are not included in the results provided below.|||Days||Standard Deviation|Mean
1393100|NCT01328496|Secondary|Number of Participants With Chronic GVHD|Due to the small sample size, cumulative incidence analysis was not done. The incidence of chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of patients with incidence of chronic GVHD by severity was provided.|1 year||||Participants|||Count of Participants
1393101|NCT01328496|Secondary|Number of Participants With Acute GVHD|The number of participants with incidence of acute GVHD by grade was given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|1 year||||Participants|||Count of Participants
1393102|NCT01328496|Secondary|Number of Observational Arm Patients With Transplant-related Mortality (TRM)|The number of patients with TRM within the first 100 days post transplant was given.|First 100 days||||Participants|||Count of Participants
1393103|NCT01328496|Secondary|Number of Deaths of Observational Arm Patients|The number of observational arm patients who died was given.|1 year||||Participants|||Count of Participants
1393106|NCT01328496|Primary|Event Free Survival (EFS) for Research Participants|Estimate EFS for research participants at one-year post transplant by using single unit umbilical cord blood. The event is defined as relapse, graft failure, death due to any cause. The number of participants who did not experience any of those events (relapse, graft failure, death due to any cause) at year 1 post-transplant was given.|1 year post-transplant||||Participants|||Count of Participants
1393107|NCT01328444|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393108|NCT01328444|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393109|NCT01328444|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393110|NCT01328444|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393125|NCT01328379|Secondary|Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.|The EQ-5D is a brief questionnaire that asks patients to rate general state of health. The VAS score rates the general state of health of a patient with 100 for the best imaginable health state and 0 for the worst imaginable health state.|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population. The number of participants analyzed corresponds with number of subjects who completed the questionnaire in each treatment group.|||units on a scale||Standard Error|Mean
1393144|NCT01328366|Secondary|Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
1393111|NCT01328444|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393112|NCT01328444|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Seconds||Standard Error|Least Squares Mean
1393113|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|12 months post enrollment|||||||
1393114|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|3 months post enrollment|||||||
1393115|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|12 months post enrollment|||||||
1393116|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|1 month post enrollment|||||||
1393117|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|1 month post enrollment|||||||
1393118|NCT01328431|Primary|Self-report of Tobacco Abstinence or Reduction|Questionnaires to assess self reported tobacco abstinence|3 months|This is the # of participants in each group.|||participants|||Number
1393119|NCT01328431|Primary|Biochemical Verification of Tobacco Abstinence|Biochemical verification means a breathalyzer reading for carbon monoxide.|3 months after enrollment|This is the # of participants in each group.|||participants|||Number
1393120|NCT01328405|Secondary|Airway Pathology|The patient will be called 24 hours later by the data collector who will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative Day Two||||participants|||Number
1393121|NCT01328405|Secondary|Airway Pathology|In the recovery area, once the patient is fully awake, as judged by the recovery staff, an observer will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative (day 1) in recovery room||||participants|||Number
1393122|NCT01328405|Secondary|Glottic View|Once the LMA has been placed and secured and the patient is stable from an anesthetic point of view, a flexible fiberoptic camera will be place into the airway tube of the LMA and the view of the patient's vocal cords in relation to the cuff of the LMA will be assessed.|Intraoperative (day 1)||||participants with grade 1 glottic view|||Number
1393123|NCT01328405|Secondary|Grossly Visible Blood or Bile on LMA|At the conclusion of the case, when the patient is breathing on their own and is awake enough, as judged by the anesthesia provider, the LMA will be removed, as would be otherwise done as standard of care. The study LMA will be examined by a data collector for the presence of grossly visible blood or bile, and its presence or absence will be recorded.|Upon LMA removal||||participants|||Number
1393124|NCT01328405|Primary|Airway Seal Pressure|The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.|Intraoperative (day 1)||||cmH2O||Standard Deviation|Mean
1393126|NCT01328379|Secondary|Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3.|"Patients completed a brief, generic health status questionnaire: The five specific dimensional scores value patients’ health related to mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each question has 3 distinguishable choices that can be analyzed using a 3-point scale (i.e. 1 = no problem, 2=some problems and 3= extreme problems).~A response of 1 indicates that the patient has no problem with the dimension tested and a response of 3 indicates that the patient has extreme problems with the dimension tested. For each visit, the average score of 5 dimensions was calculated by averaging the scores of 5 dimensions. EQ-5D final score ranges from 1-3."|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population|||units on a scale||Standard Error|Mean
1393127|NCT01328379|Secondary|Change From Baseline in Six-Minute Walk Distance at Visit 2|The Six-Minute Walk, a test of endurance, measures the distance that a patient can walk in a period of 6 minutes. Six-minute walk distance will be reported in feet.|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population|||Feet||Standard Error|Mean
1393128|NCT01328379|Secondary|Change From Baseline in MSWS-12 at Visit 2|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.~For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.~MSWS-12 Score = 100 * [(Sum of Items 1-12) – 12]/48"|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population|||scores on a scale||Standard Error|Mean
1393129|NCT01328379|Secondary|Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.~For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.~MSWS-12 Score = 100 * [(Sum of Items 1-12) – 12]/48"|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population|||scores on a scale||Standard Error|Mean
1393130|NCT01328379|Secondary|Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient’s physical disability.~A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient’s foot crosses the tape. Timing will end when any part of the patient’s foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population|||feet per second||Standard Error|Mean
1393131|NCT01328379|Primary|Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient’s physical disability.~A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient’s foot crosses the tape. Timing will end when any part of the patient’s foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population (FAP): All randomized patients who took at least one dose of double-blind investigational medication and who have a baseline Timed 25 Foot Walk (T25FW) assessment and at least one post-baseline T25FW assessment.|||feet per second||Standard Error|Mean
1393132|NCT01328366|Secondary|International Index of Erectile Function Score|The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male’s erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Male participants who completed the IIEF questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
1393133|NCT01328366|Secondary|Mean Change in Female Sexual Function Index (FSFI) Score From Baseline|The Female Sexual Function Index was a participant-reported questionnaire used to measure a female’s sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation.|4 week, 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1393134|NCT01328366|Secondary|Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female’s sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation.|Baseline; 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
1396074|NCT01300247|Secondary|Percentage of Participants Who Were Alive||Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.|||percentage of participants|||Number
1393135|NCT01328366|Secondary|Change in 12-item Short Form Survey (SF-12) Score From Baseline|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1393136|NCT01328366|Secondary|12-item Short Form Survey (SF-12) Score|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
1393137|NCT01328366|Secondary|Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant’s satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1393138|NCT01328366|Secondary|Cutaneous Body Image Scale (CBI) Scores|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant’s satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
1393139|NCT01328366|Secondary|Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.|||units on a scale||95% Confidence Interval|Mean
1393140|NCT01328366|Secondary|Hospital Anxiety and Depression Scale (HADS) Scores|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.|||units on a scale||Standard Deviation|Mean
1393141|NCT01328366|Secondary|Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1393142|NCT01328366|Secondary|Psoriasis Area and Severity Index (PASI) Scores|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
1393143|NCT01328366|Secondary|Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant’s psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months after adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1393169|NCT01328158|Secondary|Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.|||Log10 copies/mL||Standard Deviation|Mean
1393145|NCT01328366|Primary|Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline|The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant’s QOL. “Responders” to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
1393146|NCT01328366|Primary|Dermatology Life Quality Index (DLQI) Scores|The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant’s QOL. Data are reported as the mean DLQI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
1393147|NCT01328184|Secondary|Assessment of Tolerability|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.|Within Day 24 to Day 31|Treated set (TS) included all subjects who took at least one dose of study medication.|||percentage of participants|||Number
1393148|NCT01328184|Secondary|Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.|Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.|Day 1 to day 17|Treated set (TS) included all subjects who took at least one dose of study medication.|||participants|||Number
1393149|NCT01328184|Secondary|Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of levonorgestrel in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
1393150|NCT01328184|Secondary|Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of ethinylestradiol in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
1393151|NCT01328184|Secondary|Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1393152|NCT01328184|Secondary|Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1393153|NCT01328184|Secondary|Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
1393154|NCT01328184|Secondary|Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
1393155|NCT01328184|Secondary|Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||L||Geometric Coefficient of Variation|Geometric Mean
1393156|NCT01328184|Secondary|Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||L||Geometric Coefficient of Variation|Geometric Mean
1393157|NCT01328184|Secondary|Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of levonorgestrel in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1393158|NCT01328184|Secondary|Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1393159|NCT01328184|Secondary|Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Full Range|Median
1393160|NCT01328184|Secondary|Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Full Range|Median
1393161|NCT01328184|Primary|Levonorgestrel: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1393162|NCT01328184|Primary|Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1393163|NCT01328184|Primary|Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1393164|NCT01328184|Primary|Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1393165|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.|||percentage of participants|||Number
1393166|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.|||percentage of participants|||Number
1393167|NCT01328158|Secondary|Number of Participants in Each CDC Classification Category of HIV-infection Over Time|CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.|Up to Month 60 after first dose of Lopinavir/Ritonavir|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393168|NCT01328158|Secondary|Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.|||Log10 copies/mL||Standard Deviation|Mean
1393170|NCT01328158|Secondary|Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.|||cells/mm^3||Standard Deviation|Mean
1393171|NCT01328158|Secondary|Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.|||cells/mm^3||Standard Deviation|Mean
1393172|NCT01328158|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393173|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393174|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”. Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393175|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393176|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393177|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393178|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393179|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393180|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393181|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1396451|NCT01297322|Secondary|Time to Hospital Discharge (TTHD)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital|Up to 2 days||||hours||Standard Deviation|Mean
1393182|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393183|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393184|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393185|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393186|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393187|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months||||participants|||Number
1393188|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393189|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393190|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393191|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393192|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393193|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393234|NCT01327989|Primary|Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).|Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.|90 Days||||percentage of events|||Number
1393194|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All female participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393195|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender|Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
1393196|NCT01328158|Primary|Number of Adverse Drug Reactions|Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period..|||number of adverse drug reaction|||Number
1393197|NCT01328158|Primary|Percentage of Participants With Adverse Drug Reactions|Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as “Related”, “Relationship cannot be ruled out”, and “Unknown”.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||percentage of participants|||Number
1393198|NCT01328080|Primary|Percentage Change in Total AKN Lesions From Baseline to Week 16.|To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.|Baseline to Week 16||||percentage of lesion count reduction||Full Range|Mean
1393199|NCT01328054|Secondary|Median Time to Cmax (Tmax) and the Time Prior to the First Quantifiable (Non-zero) Lapatinib Plasma Concentration (Tlag) Following the Last (3rd) Lapatinib Dose|For each participant, the time at which Cmax was observed (tmax) was determined directly from the raw concentration-time data. For each participant, the time prior to the first quantifiable (non-zero) concentration (tlag) was determined directly from the raw concentration-time data. Since all participants received 2 doses of study medication prior to the collection of the first (pre-dose) blood sample on Day 4, tlag was expected to be zero. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population|||Hours||Full Range|Median
1393200|NCT01328054|Secondary|Mean Maximum Plasma Concentration (Cmax) and Observed Plasma Concentration at 24 Hours Post-dose (C24) of Lapatinib|The first occurrence of Cmax and C24 was determined directly from the raw concentration-time data. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population|||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
1393201|NCT01328054|Secondary|Mean Area Under the Plasma Drug Concentration-time Curve (AUC) From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC[0-t]) and From Time Zero (Pre-dose) to 24 Hours Post Dose (AUC[0-24]) for Lapatinib|AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-t) and AUC(0-24) were determined from the plasma concentration-time data using the linear trapezoidal rule for increased concentrations and the logarithmic trapezoidal rule for decreased concentrations. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose)|Pharmacokinetic (PK) Population: all participants in the ATS Population for whom at least one PK sample was obtained and analyzed. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1393202|NCT01328054|Secondary|Number of Participants With 12-lead ECG Findings at Indicated Time Points|The number of participants with the 12-lead ECG findings normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Baseline; on Day 1 (at pre-dose); on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-last- dose); on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-last-dose); at the End of Study visit (Day 8-11); and at the post-treatment Follow-up visit (if applicable).|BL;Day 1 (at pre-dose);Day 2 (at pre-dose, 4, 8, 12 and 24 hr post dose);Day 4 (at pre-dose, 4, 8, 12 and 24 hr post dose);End of Study visit (Day 8-11); and Follow-up (within approx 28 days following last dose of study trt [up to end of Study Week 4])|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Participants|||Number
1393271|NCT01327651|Secondary|The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews||From Week 6 to Week 30|Number of participants had product hold or product discontinuation log|||Participants|||Count of Participants
1393203|NCT01328054|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate were measured at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Beats per minute||Standard Deviation|Mean
1393204|NCT01328054|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Blood pressure measurements included SBP and DBP and were obtained at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose). Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-dose)|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1393205|NCT01328054|Secondary|Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points|Blood samples were collected for the measurement of total neutrophils (ANC), platelets, and leukocyte count at Baseline; Days 5 and 8-11. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1393206|NCT01328054|Secondary|Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points|Blood samples were collected for the measurement of calcium, chloride, CO2, potassium, sodium, magnesium and urea at Baseline; at Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1393207|NCT01328054|Secondary|Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at Baseline; Days 5 and 8-11; Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1393208|NCT01328054|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALP, ALT, and AST at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
1393209|NCT01328054|Secondary|Mean Albumin, and Hemoglobin at the Indicated Time Points|Blood samples were collected for the measurement of albumin and hemoglobin at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1393210|NCT01328054|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, or is an important medical eventsthat jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, new primary cancers, liver events, cardiac dysfunction, pneumonitis, and laboratory abnormalities.|From the start of study treatment until follow-up (within approximately 28 days following the last dose of study medication [up to end of Study Week 4])|ATS Population|||Participants|||Number
1393211|NCT01328054|Secondary|Number of Participants With the Worst-case Post-Baseline 12-lead Holter ECG Findings With Significant ST, T Wave, and U Wave Abnormalities|Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate Holter ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. The number of participants with the worst-case post-Baseline 12-lead Holter ECG findings with significant ST, T wave, and U wave abnormalities were analyzed.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Pharmacodynamic (PD) Population: all participants from the All Treated Subjects Population (ATS) who completed the ECG acquisition via Holter monitoring of at least one time point on Days 1, 2, 3 and 4.|||Participants|||Number
1393326|NCT01327339|Primary|Number of Participants With Any Adverse Event|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|one month|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments.|||participants|||Number
1393212|NCT01328054|Secondary|Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points|The number of participants with 12-lead Holter ECG findings of normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate 12-lead Holter ECGs were collected at -30, -15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10,12, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and on Day 3 for lapatinib.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.|||Participants|||Number
1393213|NCT01328054|Secondary|Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points|A Holter monitor is an ambulatory portable device for continuously monitoring the cardiovascular system. Change from Baseline in QT interval, QTc interval, QTcB interval, QTcI interval, RR interval, PR interval, and QRS duration at each time point for lapatinib was assessed in comparison with time-matched placebo. Three replicate ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 and 3 and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the average of the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. Change from Baseline was calculated by subtracting the Baseline values from individual post-Baseline values for each time point.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.|||Milliseconds||Standard Deviation|Mean
1393214|NCT01328054|Primary|Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg|A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and on Day 3 for LAP. Mean change from BL was calculated by subtracting the BL values from individual QTcF for each TP. BL adjusted mean difference in absolute QTcF between LAB and PBO (trt difference) with the corresponding 90% confidence interval (CI) was estimated for each TP (pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, and 24-hr post-dose). Trt difference analysis was performed by a repeated measures analysis of variance adjusted for trt group, TP, and trt group*TP interaction.|Baseline (BL) (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours (hr) post-dose on Day 2 for placebo (PBO). Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib (LAP).|Evaluable Population: all participants in the All-Treated Subjects (ATS) Population who met the criteria for dosing compliance, ECG acquisition, and Baseline ECG acquisition. The ATS Population is comprised of all participants who received at least one dose of study medication (placebo or lapatinib).|||Milliseconds||Standard Error|Least Squares Mean
1393215|NCT01328041|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Phenotypic Resistance Populations. Only participants with Baseline DTG IC50 with PDVF who had paired Baseline and time of virological failure samples were considered for analysis.|||Participants|||Number
1393216|NCT01328041|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Genotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF. Only participants with Baseline IN mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.|||participants|||Number
1393504|NCT01325311|Secondary|Levels of Calcidiol in the Participants Serum|This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study|Baseline and up to day 35|Due to sample one participant in Arm 1 was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Mean
1393217|NCT01328041|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.|Day 8, Week 4, and Week 24|Pharmacokinetic (PK) Parameter Population: all participants who received DTG, underwent PK sampling during the study, and provided an evaluable estimate of C0. Only participants with data available at the indicated time points were considered for analysis.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1393218|NCT01328041|Secondary|AUC(0-tau) and AUC(0-24) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.|||µg*hour/mL||95% Confidence Interval|Geometric Mean
1393219|NCT01328041|Secondary|Cmax and Ctau of DTG|The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
1393220|NCT01328041|Secondary|Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|ITT-E Population|||Participants|||Number
1393221|NCT01328041|Secondary|Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48|The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.|Baseline; Weeks 4, 12, 24, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||ratio||Inter-Quartile Range|Median
1393222|NCT01328041|Secondary|Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion|Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
1393223|NCT01328041|Secondary|Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48|Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.|Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
1393224|NCT01328041|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion|Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Log10 copies/mL||Standard Deviation|Mean
1393225|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion.|ITT-E Population|||Participants|||Number
1393226|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window|Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population|||participants|||Number
1393227|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population|||Participants|||Number
1393228|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population|||participants|||Number
1393229|NCT01328041|Primary|Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to the DAIDS grading scale. The DAIDS displays events as Grades 1-4 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, potentially life threatening.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population|||participants|||Number
1393230|NCT01328041|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population: all participants who received at least one dose of study drug|||participants|||Number
1393231|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 48|ITT-E Population|||participants|||Number
1393232|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24|The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 24|ITT-E Population|||participants|||Number
1393233|NCT01328041|Primary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8|Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.|Baseline and Day 8|Intent-to-Treat-Exposed (ITT-E) Population: all participants who received at least one dose of study drug. Only participants who had Day 8 observations were considered for analysis.|||log10 copies/milliliter (mL)||Standard Deviation|Mean
1393235|NCT01327989|Secondary|Immediate Flow Reperfusion|"Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus – Thrombolysis in Cerebral Infarction (TICI) score 2b or 3.~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|procedure|Due to insufficient imaging, the Core Lab was able to evaluated data from 190 subjects.|||percentage of participants|||Number
1393236|NCT01327989|Secondary|Incidence of Symptomatic Intracranial Hemorrhage|"Symptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs.~PH1 – Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 – Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH – Any intraparenchymal hemorrhage remote from the ischemic field IVH – Intraventricular hemorrhage SAH – Subarachnoid hemorrhage"|24 hours||||percentage of particpants|||Number
1393237|NCT01327989|Secondary|Rate of Mortality||90 Days||||percentage of particpants|||Number
1393238|NCT01327989|Secondary|Rate of Morbidity||90 Days||||percentage of particpants|||Number
1393239|NCT01327989|Secondary|Good Neurological Condition|Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation|90 Days|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||percentage of particpants|||Number
1393240|NCT01327989|Secondary|Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram|"Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow~Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During Procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Minutes||Standard Deviation|Mean
1393241|NCT01327989|Secondary|Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram|"Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow~Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Minutes||Standard Deviation|Mean
1393242|NCT01327989|Primary|Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.|"Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|Immediately post procedure|Due to insufficient imaging, the Core Lab was able to evaluate data from 190 subjects.|||percentage of particpants|||Number
1393243|NCT01327976|Primary|Percentage Responder Rate in the Treatment Arm.|The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.|12 months||||percentage of subjects|||Number
1393244|NCT01327976|Primary|Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.|Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).|12 months||||percentage of excess weight loss||95% Confidence Interval|Mean
1393245|NCT01327976|Primary|Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).|To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.|12 months|An intent-to-treat analysis was performed in the vBloc group.|||percentage of participants||95% Confidence Interval|Number
1393246|NCT01327885|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who have best overall response (BOR) of CR, or PR, or duration of stable disease (dSD) greater than or equal to 11 weeks, between Arm A and Arm B. CBR was estimated by treatment arm based on the tumor response evaluation performed by the PI or designee according to RECIST 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.|From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff (02 Jan 2015), for up to approximately 3 years 11 months|FAS (ITT analysis set) included all participants who were randomized.|||Percentage of participants||95% Confidence Interval|Number
1393247|NCT01327885|Secondary|Progression-Free Rate at 12 Weeks (PFR12wks)|The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.|From date of treatment start until Week 12|FAS (ITT analysis set) included all participants who were randomized.|||Percentage of participants||95% Confidence Interval|Number
1393505|NCT01325311|Primary|Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms|This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein|up to Day 35||||ng/mL||Standard Deviation|Mean
1393248|NCT01327885|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurred first). The date of disease progression was defined as the date of radiologic disease progression as assessed by the investigator or designee based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Participants who did not have an event (i.e., participants who were lost to follow-up or who did not progress or die at the date of data cut-off), were censored. Participants who discontinued study treatment without disease progression were censored on the date of their last radiological assessment (scan date).|Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first)|FAS (ITT analysis set) included all participants who were randomized.|||Months||95% Confidence Interval|Median
1393249|NCT01327885|Primary|Overall Survival (OS)|OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (ADI or LMS), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or >2 prior regimens).|From date of treatment start until date of death from any cause, assessed up to data cutoff date (02 Jan 2015), for up to approximately 3 years 11 months|Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.|||Months||95% Confidence Interval|Median
1393250|NCT01327703|Secondary|Nutritional Status as Assessed by Hematocrit Level|Nutritional status of participants was assessed by determining their hematocrit level. Mean hematocrit level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.|||proportion of hematocrit||Standard Deviation|Mean
1393251|NCT01327703|Secondary|Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level|Nutritional status of participants was assessed by determining their albumin, serum transferrin and hemoglobin level. Mean albumin, serum transferrin and hemoglobin level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.|||gram/L (g/L)||Standard Deviation|Mean
1393252|NCT01327703|Secondary|Nutritional Status as Assessed by Electrolytes Level|Nutritional status of participants was assessed by determining their electrolytes (sodium, potassium and chloride) level. Mean electrolytes level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.|||millimole/L (mmol/L)||Standard Deviation|Mean
1393253|NCT01327703|Secondary|Nutritional Status as Assessed by Body Mass Index (BMI)|Nutritional status of participants was assessed by determining their BMI. BMI was calculated by dividing body weight (kg) by square of height in meter (m). Mean BMI was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.|||kg/m^2||Standard Deviation|Mean
1393254|NCT01327703|Secondary|Nutritional Status as Assessed by Body Weight|Mean body weight was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.|||kg||Standard Deviation|Mean
1393255|NCT01327703|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence regardless of its causal relationship to study drug. A TEAE was defined as any event not present prior to exposure to study drug or any event already present that worsens in either intensity or frequency following exposure to test drug. A SAE was defined as any event that results in death, is immediately life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or is assessed as medically important.|Baseline up to 30 days after last dose|Safety population included all randomized participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) specifies number of participants who were evaluable for this measure.|||participants|||Number
1393256|NCT01327703|Secondary|Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data. Percent CFA was calculated separately for participants who used and did not use acid suppressing therapy (PPIs) during the study.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population. Here, 'n' specifies number of participants who were evaluable for specific categories for each arm group, respectively.|||percent CFA||Standard Error|Least Squares Mean
1393257|NCT01327703|Secondary|Percentage of Participants With Abdominal Distension|Abdominal distension is a sense of increased abdominal pressure by the participant that involves an actual measurable change in the circumference of a participant’s abdomen on physical examination. Percentage of participants with abdominal distension was calculated for each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who had abdominal distension assessment at screening and end of specified treatment.|||percentage of participants|||Number
1393258|NCT01327703|Secondary|Relative Frequency of Days With Abdominal Symptoms|Abdominal symptoms included abdominal pain and flatulence. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). For each type of abdominal symptom, the relative frequency of days with the symptom for each participant in a treatment period was calculated as the number of days in which the symptom was reported divided by the total number of days in which the abdominal symptom case report form (CRF) was completed. Mean relative frequency of days with abdominal symptoms was calculated during each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who were evaluable for this outcome measure and 'n' specifies the number of participants with at least one report of the symptom at that severity level during a treatment period.|||days||Standard Deviation|Mean
1393259|NCT01327703|Secondary|Mean Weight Per Stool Sample|Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.|||gram||Standard Deviation|Mean
1393260|NCT01327703|Secondary|Total Weight of Stools|Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.|||gram||Standard Deviation|Mean
1393261|NCT01327703|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as formed hard, normal or soft stool and abnormal consistency was defined as loose and unformed, liquid stool and diarrhea. Percentage of stools with normal consistency of each participant was calculated as the number of stools with normal consistency relative to the total number of stools during the collection period. Mean percentage of stool with normal consistency during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) specify signifies those participants who were evaluable for this outcome measure.|||percentage of stools||Standard Deviation|Mean
1393262|NCT01327703|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|Intent-to-treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||stools per day||Standard Deviation|Mean
1393263|NCT01327703|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population included all randomized participants who completed both treatment periods and had all bowel movements appropriately collected with no major protocol violations/deviations or other events considered to potentially bias the study evaluations.|||percent CFA||Standard Error|Least Squares Mean
1393264|NCT01327677|Other Pre-specified|Mean Fentanyl Consumption|Amount of cumulative fentanyl consumed in mcg|up to 24 hours postoperatively||||micrograms/ hour||Standard Error|Mean
1393265|NCT01327677|Secondary|Hypoxia|Defined by minimum oxygen saturation (SaO2)|up to 24 hours postoperatively||||Percent Oxygen Saturation||Standard Error|Mean
1393266|NCT01327677|Primary|Respiratory Depression|Defined by maximal End Tidal CO2 (mmHg)|Up to 24 hours postoperatively.||||mmHg||Standard Error|Mean
1393267|NCT01327677|Primary|Respiratory Depression|Defined by minimum respiratory rate (breaths/minute).|up to 24 hours postoperatively||||breaths/minute||Standard Error|Mean
1393268|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels|From Enrollment to week 30 (end of self-administered dosing)|Below, each seroconverted participants' drug resistance test availability was presented. If the number analyzed equal to 0 then it means the resistance test was not done. When the number analyzed equal to 1 and outcome value is 0 then it means no drug resistance was detected, but if the outcome value is 1 then it means drug resistance was detected.|||viral load|||Number
1393269|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.|From Enrollment to week 30 (end of self-administered dosing)|Below, each seroconverted participants' plasma HIV RNA levels at all visits with test results are presented|||viral load|||Number
1393270|NCT01327651|Secondary|A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm|Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.|From week 6 (randomization week) to week 30 (end of self-administered dosing)|"Below Number analyzed population only included the participants who had below adverse events, and the number next to it represent the number of participants had the corresponding AE that was related to the study product"|||Participants|||Count of Participants
1393272|NCT01327651|Secondary|The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data||From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||% of Correctly Timed Adherence|||Number
1393273|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.|From enrollment to week 30 (end of self-administered dosing)|Data is collected for plasma HIV RNA levels among all participants who seroconvert while on study, but this secondary analysis has not been carried out yet, so no outcome measure is presented here|||Participants|||Count of Participants
1393274|NCT01327651|Secondary|A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm|Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product|From week 6 (randomization week) to week 30 (end of self-administered dosing)||||Participants|||Count of Participants
1393275|NCT01327651|Secondary|Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)|Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week|week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization|Note: Not all participants were available to be analyzed at each visits below, this could be due to missed visit, drug concentration was missing, or participants did not report to have any sex in the last 7 days|||Participants|||Count of Participants
1393276|NCT01327651|Primary|Self-reported Side Effect or Symptom Scores|The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||percent of visits between week 6 to 30|||Number
1393277|NCT01327651|Primary|The Total Pills Actually Used Over the Follow-up Period|The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||Number of pills actually used|||Number
1393278|NCT01327651|Primary|The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)|Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are “covered”; Note: sex act is considered as “covered” if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||Number of pills needed for 100% coverage|sexual exposure||Number
1393279|NCT01327651|Primary|Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing|Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as “covered” if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.|From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||percentage of sexual exposures|sexual exposures||Number
1393280|NCT01327599|Secondary|Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4|All subjects using Ganfort at baseline who received study medication and attended Week 4 visit.|||millimeters mercury (mmHg)||Standard Deviation|Mean
1393281|NCT01327599|Secondary|Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 4, Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.|||percentage of participants|||Number
1393282|NCT01327599|Secondary|Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline|Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.|||units on a scale||Standard Deviation|Mean
1393283|NCT01327599|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health.|Week 12|ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.|||Units on a scale||Standard Deviation|Mean
1393284|NCT01327599|Primary|Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline|IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.|Week 12|All subjects using Ganfort at baseline who received study medication and attended Week 12 visit.|||millimeters mercury (mmHg)||Standard Deviation|Mean
1393285|NCT01327547|Secondary|Exposure-response Relationship Between Change From Baseline in Liver Fibrosis Biomarkers Versus MVC Cavg at Week 48|The relationship between change from baseline in liver fibrosis biomarkers (AST, ALT, ALK, BIL, ELF and FSCN) versus MVC Cavg was analyzed using Bayesian methods. P-values were assessed for significance in the relationship between liver fibrosis biomarkers and MVC Cavg. P-value <0.05 was regarded as significantly related.|Week 48|Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK and liver fibrosis biomarker data available.|||p-value|||Number
1393286|NCT01327547|Secondary|Summary of Estimated Maraviroc PK Parameters|Week 4 and Week 48 clinic visits were scheduled such that a trough sample may be taken within a time window of 8-16 hours after the previous dose (Ctrough). Blood samples (4mL) were collected from all participants at the Week 4 and 48 visits.|Week 48|Participants included in the statistical analysis of PK parameters were those receiving maraviroc treatment at Week 48 who had PK data available.|||ng/mL||Full Range|Median
1393287|NCT01327547|Secondary|Percentage of Participants Who Were Hospitalized Due to Hepatic Disease Through Week 144|Healthcare resource utilization data was collected using the Healthcare Resource Utilization Questionnaire at all study visits except Screening and Baseline. Other components of healthcare resource utilization, including length of hospital stay, type of ward, associated investigative and therapeutic procedures and concomitant medications were captured from primary and secondary data sources.|144 Weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
1393288|NCT01327547|Secondary|Change From Baseline in Fibrosis Score (Ishak) in Liver Biopsy Samples at Week 144|Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.|Week 144|Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.|||Numerical score||Full Range|Median
1393289|NCT01327547|Secondary|Absolute Fibrosis Score (Ishak) in Liver Biopsy Samples at Baseline and at Week 144|Samples were processed and sent to a central reader for scoring for fibrosis and other analyses such as Sirius red and α smooth muscle actin staining for activated stellate cells. Samples were collected, processed, stored and shipped in accordance with the procedure documented in a separate handling document. The Ishak fibrosis scoring system was used to score the fibrosis observed, with a minimum score of 0 and maximum score of 6 (where 0 = no fibrosis, 1 = expansion of some portal areas with or without septa, 2 = expansion of most portal areas with or without septa, 3 = expansion of most portal areas with occasional portal or portal bridging, 4 = expansion of portal areas with marked bridging [portal-portal and/or portal-central], 5 = marked bridging with occasional nodules [incomplete cirrhosis], 6 = cirrhosis, probable or definitive). The scores for liver biopsies were summarized based upon the availability of liver biopsy results.|Baseline and Week 144|Liver biopsy set consisted of 9 participants (5 MVC and 4 placebo) who had paired baseline and Week 144 liver biopsies that allowed for Ishak fibrosis scoring according to the defined secondary endpoint.|||Numerical score||Standard Deviation|Mean
1393506|NCT01325181|Secondary|Number of Participants With Adverse Event|number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events|12 months|||||||
1393290|NCT01327547|Secondary|Mean Change From Baseline in the Hepatic Elastography (FibroscanTM) at Week 48, 96 and 144|Participants had transient hepatic elastography using FibroScan technology. It rapidly and non invasively measures hepatic tissue stiffness. Through a probe, a low frequency vibration of low amplitude is transmitted to the liver. The velocity of the wave that is generated during the procedure correlates directly with tissue stiffness as it passes through the liver; the harder or stiffer the liver, the faster the shear wave propagates. Results are reported in kilopascals (kPa). A negative change in the fibroscan values (i.e. decrease in liver stiffness) correlates with a decrease in fibrosis and thus improved outcome.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||kPa||Standard Deviation|Mean
1393291|NCT01327547|Secondary|Mean Change From Baseline in Enhanced Liver Fibrosis (ELF) Test at Week 48, 96 and 144|"The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on an ADVIA Centaur XP and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1).~ELF score < 7.7: no to mild fibrosis; ≥ 7.7 — < 9.8: Moderate fibrosis; ≥ 9.8 — < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis."|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||ELF score||Standard Deviation|Mean
1393292|NCT01327547|Secondary|Mean Change From Baseline in Plasma Hepatitis B Virus (HBV) DNA at Week 48, 96 and 144|Plasma samples were used to determine HBV DNA using the Roche COBAS Taqman HBV assay. Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Log10 values||Standard Deviation|Mean
1393293|NCT01327547|Secondary|Mean Change From Baseline in Log10 Plasma Hepatitis C Virus (HCV) RNA at Week 48, 96 and 144|Plasma samples were used to determine HCV RNA using the Roche COBAS Ampliprep/COBAS HCV Taqman assay, RUO version (LOD=15 IU/mL).Baseline value for HCV RNA/HBV DNA is defined as the pre-dose measurement taken at Day 1 visit.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Log10 values||Standard Deviation|Mean
1393294|NCT01327547|Secondary|Mean Change From Baseline in Markers of Immune Activation: Transforming Growth Factor-beta (TGF Beta) - Week 48, 96 and 144|Plasma samples were used to determine markers of immune activation namely TGF beta.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||ng/L||Standard Deviation|Mean
1393295|NCT01327547|Secondary|Mean Change From Baseline in Markers of Immune Activation: D Dimer - Week 48, 96 and 144|Plasma samples were used to determine markers of immune activation namely D-Dimer.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||ng/dL||Standard Deviation|Mean
1393296|NCT01327547|Secondary|Mean Change From Baseline in Markers of Immune Activation: C-reactive Protein (CRP) - Week 48, 96 and 144.|Plasma samples were used to determine markers of immune activation namely CRP.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||mg/dL||Standard Deviation|Mean
1393297|NCT01327547|Secondary|Mean Change From Baseline in CD38 Expression on CD4 and CD8 Cells at Weeks 48, 96 and 144|Plasma samples were used to determine markers of immune activation namely CD38 expression on CD4 and CD8 cells.|48, 96 and 144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||cell/mm³||Standard Deviation|Mean
1393298|NCT01327547|Secondary|Mean Change From Baseline in CD4+ and CD8+ Cell Counts at Week 48, 96 and 144|Immunologic response (magnitude of change in CD4+ and CD8+ cell counts from baseline) was measured. Baseline value for CD4 and CD8 is defined as the pre-dose measurement taken at Day 1 visit.|Week 48, 96 and 144|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Cells/µL||Standard Deviation|Mean
1393299|NCT01327547|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Concentration <40 Copies/mL at Week 48, 96 and 144|The Food and Drug Administration (FDA’s) snapshot algorithm was used to derive the efficacy endpoint of the proportion of participants with HIV-1 RNA <40 copies/mL at Week 48. This algorithm included the missing data imputation method and used the plasma HIV-1 RNA concentration in the visit window only, followed the “virology-first principle” and considered a participant who had a missing plasma HIV-1 RNA concentration, or switched to a prohibited background anti-retroviral regimen or discontinues from the study or study drug as a failure (MSDF).|Week 48, 96 and 144|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. For calculating proportions at the analysis timepoint of interest, ie week 144, LOCF was used if the value at that timepoint was missing.|||Percentage of participants|||Number
1393300|NCT01327547|Secondary|Number of Participants With Hy's Law Abnormalities Through Week 144|Hy’s law was defined as a total bilirubin >2x ULN with a simultaneous ALT or aspartate transaminase (AST)>3x ULN, excluding participants with an alkaline phosphatase>3x ULN|144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||participants|||Number
1393507|NCT01325181|Secondary|Number of Participants Who Underwent Rescue Treatment|number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group|12 months|||||||
1393301|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities at Week 144 Associated With a Change From Baseline ALT >100 IU/L|Time to development of Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144. The median time to development was not estimable due to too few events reported under each treatment group.|||Days||95% Confidence Interval|Median
1393302|NCT01327547|Secondary|Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Associated With a Change From Baseline ALT >100 IU/L|Percentage of participants who had Grade 3 and Grade 4 ALT abnormalities associated with a change from baseline ALT >100 IU/L during the 144-week period. Baseline will be defined as the last measurement prior to Day 1 dosing.|144 weeks|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
1393303|NCT01327547|Secondary|Time to Development of Grade 3 and Grade 4 ALT Abnormalities|Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144.|144 weeks|Time taken in days to development of Grade 3 and Grade 4 ALT abnormalities defined as >5x ULN for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, at Week 144. The median time to development was not estimable due to too few events reported under each treatment group.|||Days||95% Confidence Interval|Median
1393304|NCT01327547|Secondary|Percentage of Participants With Grade 3 and Grade 4 ALT Abnormalities Through Week 144|Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 96 and Week 144 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.|Week 96 and 144|The analysis was performed on the FAS which included participant who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
1393305|NCT01327547|Primary|Percentage of Participants With Grade 3 and Grade 4 Alanine Aminotransferase (ALT) Abnormalities at Week 48|Percentage of participants with Grade 3 or Grade 4 ALT abnormalities defined as >5x upper limit of normal (ULN) for participants whose baseline ALT ≤ULN, or >3.5x baseline for participants whose baseline ALT >ULN, up to and including Week 48 in the maraviroc arm versus the placebo arm. The baseline was defined as the last measurement prior to Day 1 dosing.|48 weeks|The analysis was performed on the Full Analysis Set (FAS) which included participants who had received at least one dose of study drug. LOCF was used if the value at that time-point was missing, ie., week 48, 96 and 144.|||Percentage of participants|||Number
1393306|NCT01327508|Secondary|Distal Locking Time|Distal locking time is defined as the period between successful nail insertion without locking and the confirmation of accurate insertion of both distal screws.|Intraoperative||||minutes||Standard Deviation|Mean
1393307|NCT01327508|Primary|Radiation Exposure Measurement|"Radiation exposure measured in two ways:~Whole body badge TLD ring badge"|Intraoperative|Primary endpoint voided. Dosimeters did not capture radiation dose as expected.||||||
1393308|NCT01327495|Other Pre-specified|Progesterone||12 weeks||||ng/g||Inter-Quartile Range|Median
1393309|NCT01327495|Other Pre-specified|Pregnenolone||12 weeks||||ng/g||Inter-Quartile Range|Median
1393310|NCT01327495|Other Pre-specified|DHEA||12 weeks||||ng/g||Inter-Quartile Range|Median
1393311|NCT01327495|Other Pre-specified|Androsterone||12 weeks||||ng/g||Inter-Quartile Range|Median
1393312|NCT01327495|Other Pre-specified|Androstenedione||12 weeks||||ng/g||Inter-Quartile Range|Median
1393313|NCT01327495|Other Pre-specified|17-OHP||12 weeks||||ng/g||Inter-Quartile Range|Median
1393314|NCT01327495|Other Pre-specified|17-OHPreg||12 weeks||||ng/g||Inter-Quartile Range|Median
1393315|NCT01327495|Secondary|International Prostate Symptom Score (IPSS)|IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic|12 weeks||||units on a scale||Inter-Quartile Range|Median
1393316|NCT01327495|Secondary|Prostate Volume||12 weeks||||cm^3||Inter-Quartile Range|Median
1393317|NCT01327495|Secondary|Prostate Specific Antigen||12 weeks||||ng/dL||Inter-Quartile Range|Median
1393318|NCT01327495|Primary|Prostate Tissue Testosterone Concentrations After Treatment|To measure intraprostatic testosterone levels|12 weeks||||ng/g||Inter-Quartile Range|Median
1393319|NCT01327495|Primary|Dihydrotestosterone (DHT)||12 weeks||||ng/mL||Inter-Quartile Range|Median
1393320|NCT01327495|Primary|Serum Testosterone||12 weeks||||ng/mL||Inter-Quartile Range|Median
1393321|NCT01327495|Primary|Prostate Tissue DHT Concentrations After Treatment|To measure intraprostatic dihydrotestosterone [DHT] levels|12 weeks||||ng/g||Inter-Quartile Range|Median
1393322|NCT01327482|Secondary|Plasma Raltegravir Concentrations|Mean trough concentration from all 3 days|7, 14, 21 days||||ng/mL||Standard Deviation|Mean
1393323|NCT01327482|Primary|Tissue Raltegravir Concentrations|Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method.|7, 14, 21 days||||ng/mL||Standard Deviation|Mean
1393324|NCT01327339|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|one month|ITT Population|||participants|||Number
1393325|NCT01327339|Secondary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|one month|ITT Population|||participants|||Number
1393327|NCT01327313|Secondary|Accumulation Ratio (Rac)|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at 3rd infusion divided by area under the serum concentration-time curve within one complete dosing interval at 1st infusion.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1 and Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1393328|NCT01327313|Secondary|Percentage Peak-Trough Fluctuation (PTF)|The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [Cmax - Cmin] / Cav ) multiplied by 100.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
1393329|NCT01327313|Secondary|Mean Residence Time at Steady State (MRTss)|MRTss = (AUMCtau + tau(AUCinf – AUCtau))/ AUCtau) - T/2, where AUMCtau was the area under the first moment curve within one complete dosing interval and T was the infusion duration. Area under the serum concentration-time curve from time zero to infinity, calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
1393330|NCT01327313|Secondary|Mean Residency Time (MRT0-inf)|MRT0-inf of drug in the body was calculated by dividing the area under the first moment curve from time zero to infinity with area under the first moment curve from time zero to infinity minus half of infusion of duration (MRT0-inf = AUMC0-inf/AUMC0-inf - T/2).|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour||Geometric Coefficient of Variation|Geometric Mean
1393331|NCT01327313|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
1393332|NCT01327313|Primary|Apparent Volume of Distribution: After Multiple Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/(Area under the serum concentration-time curve within one complete dosing interval [AUCtau]* λz) following multiple dose.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
1393333|NCT01327313|Primary|Pharmacokinetics of EMD 525797 - Trough Values|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393334|NCT01327313|Primary|Apparent Volume of Distribution (Vz): After Single Dose|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the serum concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. A minimum of three points is required to calculate λz.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||liter||Geometric Coefficient of Variation|Geometric Mean
1393335|NCT01327313|Primary|Total Body Clearance at Steady State (CLss) of EMD 525797|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL of drug in serum was calculated as : CL= Dose/ AUC0-inf. Area under the serum concentration-time curve from time zero to infinity (AUC0-inf), calculated as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is the elimination rate constant.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
1393336|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393337|NCT01327313|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval( AUCtau): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393338|NCT01327313|Secondary|Average Serum Concentration at Steady State (Cav)|The Cav was calculated by dividing the area under the serum concentration-time curve within one complete dosing interval (AUCtau) by the dosing interval (2 weeks or 336 hoursi.e. Cav =AUCtau/tau).|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393339|NCT01327313|Secondary|Observed Serum Concentration Immediately Before Next Dosing (Cpre)|The observed serum concentration immediately before next dosing determined directly from the serum concentration-time profile of each subject (= trough concentration)|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393340|NCT01327313|Secondary|Minimum Observed Serum Concentration (Cmin) After Multiple Doses|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393341|NCT01327313|Secondary|Elimination Rate Constant ( λ z): After Multiple Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||per hour||Geometric Coefficient of Variation|Geometric Mean
1393342|NCT01327313|Secondary|Elimination Rate Constant (λz): After Single Dose|The elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||per hour||Geometric Coefficient of Variation|Geometric Mean
1393343|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour||Full Range|Median
1393344|NCT01327313|Secondary|Time to Maximum Observed Serum Concentration (Tmax): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour||Full Range|Median
1393345|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Multiple Dose||Pre-dose, EOI, 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour||Full Range|Median
1393346|NCT01327313|Secondary|Apparent Terminal Half Life (t1/2): After Single Dose||Pre-dose, end of infusion (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour||Full Range|Median
1393347|NCT01327313|Secondary|Progression-free Survival (PFS)|PFS time was defined as the time (in months) from the first dosing date to the date of first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST version 1.0) or death for any cause within 12 weeks after last tumor assessment. Subjects without event are censored on the date of last tumor assessment.|From first dosing date until disease progression or death, maximum up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.|||months||Full Range|Median
1393367|NCT01327157|Other Pre-specified|Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale .|The correlation between the increase of the number of the dental contacts and the VAS evaluation final result from chronic peripheral facial paralysis patients, according to control and treated groups by the neuro occlusal rehabilitation technic.|Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||correlation coefficient|||Number
1393508|NCT01325181|Secondary|Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography|change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period|12 months|||||||
1393348|NCT01327313|Secondary|Number of Subjects With Clinical Benefit|Clinical benefit was defined as presence of at least one confirmed CR, PR, or stable disease (SD) lasting at least 12 weeks according to RECIST v1.0. Per RECIST v1.0: CR was defined as disappearance of all target and non-target lesions and normalization of serum levels of tumor markers . PR was defined as >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.|||subjects|||Number
1393349|NCT01327313|Secondary|Number of Subjects With Overall Tumor Response|Overall tumor response was defined as the presence of at least one confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0. Complete response was defined as the disappearance of all target and non-target lesions and normalization of serum levels of tumor markers. PR is at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Baseline up to Week 36|Full analysis set included all subjects who received at least one (non-zero) administration of the trial medication.|||subjects|||Number
1393350|NCT01327313|Primary|Total Body Clearance (CL) of EMD 525797: After Single Dose|Total body clearance of drug in serum was calculated: as CL= Dose divided by Area under the serum concentration-time curve from time zero to infinity (AUC0-inf).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
1393351|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Multiple Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above LLQ.|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393352|NCT01327313|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC0-t) of EMD 525797: After Single Dose|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above Lower limit of quantification (LLQ).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||hour*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393353|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax) of EMD 525797:After Multiple Dose||Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 5|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797. Here N (number of subjects analyzed) signifies the total number of subjects evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1393354|NCT01327313|Primary|Maximum Observed Serum Concentration (Cmax): After Single Dose||Pre-dose, hour 1(end of infusion [EOI]), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The pharmacokinetic (PK) analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1393355|NCT01327313|Primary|Number of Subjects With Dose-limiting Toxicities (DLTs)|DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring at any dose level until the end of Week 4, and suspected to be reasonably related to the investigational medicinal product by the Investigator and/or Sponsor. Toxicities not considered to be DLTs are as follows- Allergic reactions or anaphylaxis; any Grade 3 or 4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days, unless the Investigator decided this event is clinically significant. For this reason Grade 3 or 4 out-of-range laboratory values must be re-assessed within 7 days. In case the Investigator provides the subject any treatment(s) due to the out-of-range laboratory values, the event was regarded as a DLT.|Baseline up to Week 4|Dose escalation analysis set/DLT analysis set included all subjects who experienced a DLT or subjects who did not experience a DLT and had a relative dose intensity of >= 75 percent (%) during the DLT observation period.|||subjects|||Number
1393356|NCT01327300|Secondary|Intestinal Permeability Testing|"Ability of test substances to permeate the intestinal mucosa. The Lactulose/Mannitol test (Genova Diagnostics®, Ashville, NC) directly measures the ability of mannitol and lactulose to permeate the intestinal mucosa. Patient ingests 5 grams of lactulose and 2 grams of mannitol dissolved in a 100 ml of water. Urine is then collected for 24 hours and the ratio of the urinary excretion of lactulose to mannitol is measured. This testing is performed only after completion of each treatment period , after 12 weeks of mesalamine and after 12 weeks of placebo.~Normal ratio of lactulose/mannitol is any value <0.7. An abnormal ratio is defined as >0.7 ratio. The lactulose is measured in the urine as g/kg and the urinary excretion of mannitol is also measures as g/kg."|At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)||||ratio||Full Range|Mean
1393368|NCT01327157|Secondary|Visual Analog Scale|"It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002).~Patients were asked to fill the VAS with the following questions. Do you chew well? How would you classify your chewing at the moment? If you have no trouble chewing, the rating is zero. If you have any discomfort when you chew, your reference level is five. If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale."|After 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||units on a scale||Standard Deviation|Mean
1393357|NCT01327300|Secondary|Hospital Anxiety and Depression Scale (HADS)|"A questionnaire is given to each patient with scoring done on a Likert scale ranking from 0-42 which combines anxiety and depression scales. Each of these are scored from 0-21 depending on anxiety versus the depression parameters. Comparison of change in HADs after 12 weeks of intervention with either mesalamine or placebo is provided here with only the total value provided-range is from 0-42.~Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 3 with zero being none at all or occasional and 3 as most of the time. The scale used is a Likert scale and therefore the data returned from the HADS is ordinal.~The best score for the HADS therefore is a 0 with the worst score a 42 for combined anxiety and depression scores.~For the subscales of depression and anxiety, the best score is a 0 and the worst is a 21. This data is not provided here.~Data below includes the change from baseline in the HADS scores."|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)||||units on a scale||Standard Deviation|Mean
1393358|NCT01327300|Secondary|IBS - Quality of Life (IBS-QOL)Score.|A questionnaire is given to each patient and was completed at baseline then after 12 weeks of intervention with mesalamine and then placebo in the cross-over study. The IBS-QOL comprises 34 items with 5-point response scales (0 to 4) that cover eight dimensions of HRQL: dysphoria (8 items), interference with activity (7 items), body image (4 items), health worry (3 items),food avoidance (3 items), social reaction (4 items), sexual concerns (2 items) and relationships (3 items). Higher values indicate better HRQL after converting the raw score on the IBS-QOL into 0 to 100 points.|at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)|Data are the mean change in IBS-QOL between baseline and intervention|||units on a scale||Standard Deviation|Mean
1393359|NCT01327300|Secondary|Functional Bowel Disorder Severity Index (FBDSI)|Subjects rate pain on a standardized scale. This is a standardized test used to evaluate patients with IBS. Baseline values are compared to 12 weeks after mesalamine and 12 weeks after placebo treatments. The FBDSI is score is interpreted as such: Severity of IBS is rated as none (0 points), mild (1-36 points), moderate as 37-110 points and severe as >110 points. Therefore patients can have a score higher than 110.|An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period.|Change in Functional Bowel Disorder Severity Index (FBDSI)after 12 weeks of intervention.|||units on a scale||Standard Deviation|Mean
1393360|NCT01327300|Secondary|Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline.|"Colonoscopy/flexible sigmoidoscopy will be performed and mucosal biopsies will be obtained. Each biopsy was stained for activated t lymphocytes, mast cells and eosinophils .~CD117 staining was done for Mast cells. H and E staining was used to identify lymphocytes and eosinophils. Each path specimen was then noted to have increased versus normal number of these inflammatory cells."|For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years)||||participants|||Number
1393361|NCT01327300|Primary|Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo|Patients rated the severity of their GI symptoms. The GIS scale goes from 1 to 7 with 1 being the worse and 7 as the best score showing improvement in symptoms. The GIS was performed at week one and at week 12 during each of the interventions. The comparisons below list the mean difference for each intervention from baseline (BL) with standard deviations then we list the p-value for the differences of baseline to intervention are reported using the Mann-Whitney test with a two-tailed p value provided.|Baseline and at 12 weeks post-intervention|The first part of the analysis compares the differences between baseline and mesalamine to baseline and placebo. The P value provided below list the comparison of baseline-placebo to baseline-mesalamine using the Mann-Whitney statistical analysis.|||units on a scale||Standard Deviation|Mean
1393362|NCT01327274|Secondary|Patient Satisfaction During the Treatment|. Patients were asked to fill out questionnaire at 2 intervals: 1 month after explant and 1 year after explant|One month and one year after explant.|14 Participants offered recommendations at 2 time intervals|||Participants|||Count of Participants
1393363|NCT01327274|Secondary|Chest Wall Correction, by Pectus Severity Index|Though not powered to determine efficacy, preliminary efficacy data, as measured by pre and post treatment Pectus Severity Index (Haller Index), was also collected. Pre-treatment Haller Index was assessed based on computed tomography (CT) of the chest. One month after implant removal, patients underwent repeat chest CT to evaluate chest wall correction.|24 months|All patients who have received post-treatment chest wall imaging.|||Participants|||Count of Participants
1393364|NCT01327274|Secondary|Comfort and Brace Wear During Treatment|Comfort of the external brace directly affects compliance (i.e., bracewear) and compliance were be measured throughout treatment. In addition, the satisfaction of the patient and family will be measured using a standard Quality of Life (QOL) questionnaire administered 1 month after implanting the device and 1 month after removing the device.|During treatment, 24 months||||Participants|||Count of Participants
1393365|NCT01327274|Primary|Number of Participants With Adverse Reactions|All adverse reactions were recorded and reported, including complications from implantation of the device, complications from application of the external device over time (e.g., changes in skin; infection; changes in cardiac electrical function).|During treatment, 24 months||||Participants|||Count of Participants
1393366|NCT01327157|Other Pre-specified|Correlation Between the Increase of the Number of Dental Contact Points and the Improvement in the Subjective Evaluation Measured Through the Visual Analogic Scale Whithout the Outlier.|"The correlation between the increase of the number of the dental contacts and VAS evaluation final result from chronic peripheral facial paralysis patients.~On this measure was excluded one outlier patient whose facial paralysis appeared in her childhood.~Observing the outlier patient, it was carried out a new scatterplot, ignoring her."|Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||correlation coefficient|||Number
1393378|NCT01326962|Secondary|Number of Participants With C-Reactive Protein Abnormality|CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||mg/L|||Number
1393369|NCT01327157|Primary|Brand Carbon Count on Gnathostats Models|Only in the treatment group were done gnatostatic models.The models were placed occluding brought with carbon, using the willis compass to keep occluding the posterior base of the model which are aligned with the rear. A model of the teeth was made to measure the occlusion of the teeth (i.e., the amount of contact between the upper and lower mandibles), and used carbon to count the the number of dental contacts, through the brand carbon made on the model, The dental contacts were counted in the models before and after treatment. The models are made in the first and last query.|Day 01 and after 90 days of treatment (Day 180 for Treatment participants first receiving Placebo)||||number of dental contacts||Standard Deviation|Mean
1393370|NCT01327157|Primary|The Visual Analog Scale for Pain Was Used to Grade Discomfort in Chewing After the Installation of Facial Paralysis. Level Zero is the Lack of Discomfort and 10 is the Maximum Degree of Discomfort.|"It is a scale-shaped ruler, which is associated with faces used to grade the degree of pain for patients, before and after treatments, or just graduating pain and its severity for the patient (Souza, 2002).~Patients were asked to fill the VAS with the following questions.~Do you chew well?~How would you classify your chewing at the moment?~If you have no trouble chewing, the rating is zero.~If you have any discomfort when you chew, your reference level is five.~If the discomfort is intense, its reference level is ten. The greater the discomfort, the greater the scale."|Day 1 (Day 91 for Treatment participants first receiving Placebo)|All participants were treated by intention to treat.|||units on a scale||Standard Deviation|Mean
1393371|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review - Per FAS|Rate of complete response is the proportion of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR will be determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of ‘Unknown” will be treated as non responders|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.|||Percentage of participants||95% Confidence Interval|Number
1393372|NCT01327053|Secondary|Complete Response Rate (CRR) Per Central Review - Per pEAS|Rate of complete response is the proportion of patients with best overall response of complete response (CR) after starting LDE225 treatment. The rate of CR will be determined according to mRECIST for laBCC and RECIST 1.1 for mBCC. Patients with best overall response of ‘Unknown” will be treated as non responders|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, and including all patients with mBCC included in the FAS.|||Percentage of participants||95% Confidence Interval|Number
1393373|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC Per FAS|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.~Median DoR for patients with laBCC was non-estimable for both treatment arms. Median DoR was non-estimable for patients with mBCC receiving treatment with sonidegib 200 mg.~Duration of response was for participants with ORR."|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.|||Months||95% Confidence Interval|Median
1393374|NCT01327053|Secondary|Duration of Response (DoR) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC -Per pEAS|"Duration of response is the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.~Median DoR for patients with laBCC was non-estimable for both treatment arms as limited numbers of progressive disease (PD) or deaths were observed as of the 28-Jun-2013 data cut-off date. Median DoR was non-estimable for patients with mBCC receiving treatment with sonidegib 200 mg.~Duration of response was for participants with ORR."|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, and including all patients with mBCC included in the FAS.|||Months||95% Confidence Interval|Median
1393375|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS)|ORR is the proportion of patient’s objective response (ORR) by 6 months after starting LDE225 treatment. A responder will be defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher.|6 months|The primary efficacy analysis set (pEAS) was a subset of the FAS including patients with laBCC with tumors that were adequately assessed by magnetic resonance imaging (MRI) or photography or both, and including all patients with mBCC included in the full analysis set (FAS).|||Percentage of participants||95% Confidence Interval|Number
1393376|NCT01327053|Primary|Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS).|ORR is the proportion of patient’s objective response (ORR) by 6 months after starting LDE225 treatment. A responder will be defined as a subject with confirmed partial response (PR) or confirmed complete response (CR) 6 months after starting LDE225 treatment.Treatment with sonidegib was to be considered sufficiently efficacious if the observed ORR on any treatment arm at the end of the study was 30% or higher.|6 months|The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle.|||Percentage of participants||95% Confidence Interval|Number
1393377|NCT01326962|Secondary|Number of Participants With Erythrocyte Sedimentation Rate Abnormality|ESR is an acute phase reactant and is a measure of inflammation. It is measured in millimeter per hour (mm/hr).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
1393509|NCT01325181|Secondary|Number of Participants With Leakage on Fluorescein Angiography|number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period|12 months|||||||
1393379|NCT01326962|Secondary|Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient’s Global Assessment of Pain (VAS); Patient’s Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
1393380|NCT01326962|Secondary|Number of Participants With AE or SAE Related Discontinuation of Tocilizumab|It included participants who discontinued from the study due to occurrence of AE or SAE.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.|||participants|||Number
1393381|NCT01326962|Secondary|Number of Participants With Any Adverse Event and Serious Adverse Event|An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to 1 year|Safety population included all participants who had received at least one dose of study medication.|||participants|||Number
1393382|NCT01326962|Primary|Change in Fatigue as Measured Using the Fatigue Visual Analog Scale|The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||units on a scale|||Number
1393383|NCT01326962|Primary|Changes in Participant’s Fatigue Assessed Using the Mean FACIT-Fatigue Score|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, ‘n’ = number of participants analyzed at particular point of time.|||Units on a scale|||Number
1393384|NCT01326962|Primary|Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response|Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
1393385|NCT01326962|Primary|Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)|DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
1393386|NCT01326962|Primary|Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
1393405|NCT01326728|Other Pre-specified|Tumor Immune Response Graft-Versus-Leukemia (GVL)|GVL is a donor anti-tumor response following transplant.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393387|NCT01326962|Primary|Time to Das28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.|||Day||Standard Error|Mean
1393388|NCT01326962|Primary|Number of Participants Who Achieved Remission (DAS28 < 2.6)|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|ITT consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.|||participants|||Number
1393389|NCT01326962|Primary|Disease Activity as Measured by Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Up to 1 year|The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.|||units on a scale||Inter-Quartile Range|Median
1393390|NCT01326910|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA)|An assessment of Atopic Dermatitis based on a 4 point scale where 0 (none) and 3 (severe) are used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating will be 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe, or 5-very severe.|through Week 3|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1393391|NCT01326910|Secondary|Assessment of Itch|Subject’s or caregiver’s assessment of itch, on a 10-cm Visual Analogue Scale (VAS), where 0-no itch, 10-worst itch imaginable|through Week 3|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1393392|NCT01326910|Secondary|Interim Eczema Area and Severity Index (EASI)|Number of subjects improved at Week 2 compared to Baseline in EASI. Improved is defined as post baseline EASI score smaller than baseline score.|Week 2|Intention to Treat|||participants|||Number
1393393|NCT01326910|Primary|Eczema Area and Severity Index (EASI)|A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72|3 weeks|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1393394|NCT01326845|Secondary|Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months|||||||
1393395|NCT01326845|Secondary|Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups||3 months, 6 months|||||||
1393396|NCT01326845|Secondary|the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|3 months, 6 months|||||||
1393397|NCT01326845|Secondary|Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6|||||||
1393398|NCT01326845|Secondary|Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6|||||||
1393399|NCT01326845|Secondary|Difference in Severity of Overall GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.|||||||
1393400|NCT01326845|Secondary|Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.|||||||
1393401|NCT01326845|Secondary|Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.|Study was prematurely terminated and not powered for efficacy.|6 months|||||||
1393402|NCT01326845|Primary|Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms|Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section.|3 months|||||||
1393403|NCT01326728|Other Pre-specified|Recovery of Clinical Immunity After Allotransplant|Improved serologic responses after allotransplant.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393404|NCT01326728|Other Pre-specified|Relapse After Day 100 or Following Treatment of Graft Versus Host Disease (GVHD)|Participants who were initially in remission.|After Day 100 or Following Treatment of GVHD|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393406|NCT01326728|Other Pre-specified|Regimen-Specific Sensitivity After Allotransplant|Regimen-specific sensitivity are new or renewed sensitivity to therapies following allotransplant.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393407|NCT01326728|Other Pre-specified|Count of Participants With Clinical Blood Markers of Inflammation|Count of participants with clinical blood markers of inflammation. Normal to low blood markers indicate relapse. Falling blood marker levels indicate possible imminent relapse.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393408|NCT01326728|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|5 years||||Participants|||Count of Participants
1393409|NCT01326728|Primary|Count of Participants With Infection After Allotransplant|Count of Participants with Infection After Allotransplant.|up to 100 days or more post allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393410|NCT01326728|Primary|Count of Participants With Chronic Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant|Mild chronic GVHD involves only 1 or 2 organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites). Moderate GVHD involves at least 1 organ or site with clinically significant but no major disability (max. score of 2 in any affected organ or site), or 3 or more organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites), and a lung score of 1 will also be considered moderate chronic GVHD. Severe chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site). A lung score of 2 or greater will also be considered severe chronic GVHD.|100 days post allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393411|NCT01326728|Primary|Count of Participants With Acute Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant|Acute GVHD is defined as GVHD that presents with signs and symptoms typical of acute GVHD but presenting after day 100 post allotransplant. Clinical Staging Grade 2 ((+) to (+++) Skin; (+) Liver; and (+) Gut) involvement, Grade 3 ((++) to (+++) Skin; (++ to +++) Liver; and (++ to +++) Gut) involvement, and Grade 4 ((++) to (++++) Skin; (++ to ++++) Liver; and (++ to ++++) Gut) involvement.|100 days or more post allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393412|NCT01326728|Primary|Days to Engraftment|Number of days for a participant to reach engraftment.|up to 100 days or more following allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393413|NCT01326728|Primary|Overall Survival|Overall Survival is the time between the first day of treatment to the day of death.|first day of treatment to the day of death|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393414|NCT01326728|Primary|Time to Progression After Allotransplant|Time to Progression is the time between the first day of treatment to day 100 after allotransplant.|first day of treatment to day 100 after allotransplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393415|NCT01326728|Primary|Immune Suppression|Biological response to agents and or treatments that can lead to bone marrow suppression/ cytopenias and sometimes death.|up to 100 days or more following transplant|Protocol specified data were not to be summarized or analyzed unless 30-40 total pts in both grps (no relapse, relapse) are available (to permit a given comparison to have approx. 80% power for a test with an effect size of 1.0 and 0.05 two-sided alpha level). PI of the study left the NIH before this number was reached and the study was terminated.||||||
1393416|NCT01326533|Secondary|Beta Cell Function|Change from baseline in the disposition index (DI)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data|||arbitrary units||Standard Error|Mean
1393417|NCT01326533|Primary|Insulin Sensitivity|Change from baseline in the insulin sensitivity index (Si)|13 weeks after baseline measurement|all randomized with last observation carried forward for missing data|||10^-4/pmol*l/min||Standard Error|Mean
1393418|NCT01326026|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
1393419|NCT01326026|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
1393420|NCT01326026|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Events/100 years of patient exposure|||Number
1393421|NCT01326026|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
1393422|NCT01326026|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1393423|NCT01325870|Secondary|Mean Intrathoracic Pressure (Airway Pressure)|Intrathoracic pressures are reported relative to atmospheric pressure|during CPR (day 1)||||mmHg||Standard Deviation|Mean
1393424|NCT01325870|Primary|Serious Adverse Events|Serious adverse events include: death, internal thoracic and abdominal injuries, device malfunction preventing use during CPR|during the index CPR procedure (day 1), at hospital discharge, at 30 days, at three months, and at six months of follow-up||||events|||Number
1393425|NCT01325870|Primary|Mean Systolic and Diastolic Blood Pressures||during CPR (day 1)||||mmHg||Standard Deviation|Mean
1393426|NCT01325792|Secondary|Early and Long-term Complication Rates|Surgical site abdominal wound event rate|after surgery (day 1) to 24 months||||% of subjects with events|||Number
1393427|NCT01325792|Primary|Hernia Recurrence Rate|Investigator confirmed hernia recurrence by physical examination|at about 24 months||||% of subjects with recurrent hernia||95% Confidence Interval|Number
1393428|NCT01325714|Secondary|Caregiver-perceived Mutuality|"Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale.~Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal.~responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported mutuality.|||units on a scale||Standard Deviation|Mean
1393429|NCT01325714|Secondary|Caregiver Burden|"Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always.~Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden."|Baseline, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver burden.|||units on a scale||Standard Deviation|Mean
1393430|NCT01325714|Secondary|Pleasant Events - Short Form - Alzheimer's Disease|"The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease.~For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no).~For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together.~The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events."|Baseline, 0, 3, 6, 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in frequency of pleasant events.|||units on a scale||Standard Deviation|Mean
1393431|NCT01325714|Secondary|Depression|"Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item.~Total GDS scores range from 0 to 30, with greater scores indicating greater depression."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
1393432|NCT01325714|Secondary|Patient-reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
1393510|NCT01325181|Secondary|Change From Baseline in Central Foveal Thickness on OCT|the change from baseline in central foveal thickness measured by OCT throughout the follow-up period|12 months|||||||
1393433|NCT01325714|Secondary|Caregiver Reported Overall Pain Over the Last Several Weeks|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months.|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
1393434|NCT01325714|Secondary|Patient-reported Worst Pain.|"This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity."|Baseline, 3, 6, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in patient-reported worst pain.|||units on a scale||Standard Deviation|Mean
1393435|NCT01325714|Secondary|Caregiver-Reported Worst Pain|"This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.~Higher scores = greater pain severity"|Baseline, 3 months, 6 months, and 12 months|Growth curve models were conducted (n = 203) to examine whether there were treatment group differences in change over time in caregiver-reported worst pain.|||units on a scale||Standard Deviation|Mean
1393436|NCT01325714|Primary|Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)|"The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred less than once a week or more often) and disruptiveness (i.e., it was a little disruptive or more), he/she was considered aggressive.~Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors.~One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors.~One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors."|Three Months, Six Months, Twelve Months Post Intervention|203 community-dwelling Veterans with pain and dementia and their caregivers|||participants|||Number
1393437|NCT01325701|Secondary|Ibrutinib and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|"Treatment Group 1 PK collection schedule:~Cycle 1 Day 1: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 8: Pre-dose, 1, 2, 4, 7, and 24 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose~Treatment Group 2 PK collection schedule:~Cycle 1 Day 8: Pre-dose, 1, 2, 4 and 7 hours post-dose Cycle 1 Day 15: Pre-dose and 2 hours post-dose Cycle 1 Day 22: Pre-dose and 2 hours post-dose Cycle 3 Day 1: Pre-dose, 1, 2, and 4 hours post-dose"|Performed during the first month of receiving study drug.|PK samples were collected in all participants (n=70 and 8 in PCI-32765: 560 mg and 840 mg, respectively). Of these, 59 participants in PCI-32765: 560 mg and 7 in PCI-32765: 840 mg on Cycle 1 Day 8 were evaluable for PK.|||ng*h/mL||Standard Deviation|Mean
1393438|NCT01325701|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Participants will be followed until progression of the disease or start of another anticancer treatment. The clinical database captured all AEs from baseline through end of treatment. Treatment Emergent AEs were collected pre-dose, at the beginning of each cycle and 30 days post last dose of study drug, unless related to study drug.|Adverse events determined to be related to study drug are collected from first dose until study exit (approximately 3 years).||||participants|||Number
1393439|NCT01325701|Primary|Percentage of Patients With an Overall Response to Study Drug|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin’s lymphoma (Cheson et al, 2007), as assessed by the investigator.|The median follow up time on the study for all treated participants is 1.7 months (range 0.1- 32.3 months)||||percentage of participants|||Number
1393440|NCT01325623|Secondary|Post-stimulation Heart Rate Changes|During a 1 hour period during the EMU stay, the VNS Therapy device was programmed to normal mode stimulation ON time 30 seconds, OFF time 5 minutes. AutoStim and Magnet Mode were programmed OFF. In this hour, 10 to 11 normal mode stimulations can be expected. Around each of these stimulations, ECG data were collected to assess potential stimulation related heart rate changes (during stimulation, after stimulation and after black-out time). A black-out time is a period after stimulation during which no seizure detections can occur, to ensure that potential stimulation related heart rate changes were not seen as ictal tachycardia that would trigger false positive detection. During the trial, the black-out time was programmed to 30 seconds. The heart rate changes for all stimulations and all patients were averaged.|EMU stay|ITT population|||percentage change||Standard Deviation|Mean
1393441|NCT01325623|Secondary|Overall Summary of Seizure Intensity by Subgroup|Quantitative evaluation of EEG was used to characterize the seizures that were treated with Automatic Stimulation. Intensity was evaluated by surveying the average power level from the 10-20 system EEG channel of maximum output during the course of the seizure. Intensity was only reported for seizures with intensity annotated and >= 20% Heart Rate Rise. The relative intensity was calculated by normalizing the power calculations to the pre-seizure state, and thus the reported changes are dimensionless. n= number of seizures|Historical Seizures and Seizures during Epilepsy Monitoing Unit Stay|Patients from the ITT population who had at least one seizure during EMU stay and who had at least one historical seizure recorded. n=total number of seizures|||unitless||Standard Deviation|Mean
1393442|NCT01325623|Secondary|Changes in Quality of Life on Patient Reported Questionnaire (QOLIE-31-P)|Quality of life data was collected using patient‐completed QOLIE‐31‐P surveys and compared between baseline and follow‐up visits. The MIC score for each subscale defines the threshold for Minimally Important Change. If a score exceeds the MIC Score, the improvement from baseline is considered clinically significant. The range for QOLIE-31-P (all sub-scores) is 0-100 with higher scores reflecting greater well-being.Subscale scores were averaged to compute the QOLIE Total Score.|up to 24 Months Visit|ITT Population|||units on a scale||Standard Deviation|Mean
1393443|NCT01325623|Secondary|Summary of Post Ictal Duration (Seconds) for All Seizure Types (ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Post-ictal duration was quantified by identifying the time at which the number of EEG channels within the 95% confidence interval of relative power reaches a number that is consistent with that during the pre-seizure period. This measure represents the amount of time required following a seizure until the EEG recovers to the pre-seizure state. It is used to objectively estimate patient recovery time. Historical seizures were baseline EEG recordings measured during monitoring prior to implantation. Post-ictal duration is only reported for seizures with Post Ictal Duration (seconds) annotated and >= 20% Heart Rate Rise|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures|||Seconds||Standard Deviation|Mean
1393444|NCT01325623|Secondary|Summary of Seizure Duration (Seconds) for All Seizure Types by Subgroup(ITT Population) (Only Seizures With Post Ictal Duration (Seconds) Annotated)|Seizure duration was calculated using historical EEG data from patients enrolled in the trial and compared to the duration of seizures that occurred during the study EMU stay. The seizure start and end times were determined via clinical observation and/or through an adjudication process with qualified EEG reviewers.|Historical Seizures and Seizures during Epilepsy Monitoring Unit Stay|Patients from the ITT population who had at least one seizure during the EMU stay and who had at least one historical seizure recorded (and duration was annotated). n=total number of seizures|||Seconds||Standard Deviation|Mean
1393445|NCT01325623|Secondary|Proportion of Seizures Ending During Stimulation by Type|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population; All Treated Seizures n=total number of seizures|||Percentage of Seizures Ending|||Number
1393446|NCT01325623|Secondary|Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Seizure Severity Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 and 24 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.~Mean SSQ scores at 3, 6, 12, 18 and 24 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire. Subscale scores were averaged to compute the SSQ Total Score"|Up to 24 Month visit|ITT Population|||Units on a scale||Standard Deviation|Mean
1393447|NCT01325623|Secondary|Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.~Negative median value means improvement."|up to 24 Months Visit|ITT Population|||Units on a scale||Full Range|Median
1393448|NCT01325623|Secondary|Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6, 12, 18 and 24 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 24 Month visit|ITT population|||Percentage of participants||95% Confidence Interval|Number
1393449|NCT01325623|Secondary|Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from Extremely Difficult (5) to Extremely Easy (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery and the end of EMU.~Usability was calculated as percentage of the users who found the usability of system to be easy-2 or extremely easy-1."|At implant/recovery up to EMU Discharge (2 to 4 weeks)|ITT Population|||Percentage of participants rated 1 or 2|||Number
1393450|NCT01325623|Secondary|Characterization of Latency Period: Analysis of Observed Latency for True Positive Detections by Randomized SDA Setting|Latency is defined as the time difference between SDA detection time and the annotated seizure onset time. The earliest SDA detection was considered for each seizure. Seizure onset times were compared with M106 device detections at the randomized SDA setting. Negative latencies indicate that the SDA detection preceded the seizure onset time. The median latency is presented for seizures which met the definition of ictal tachycardia as well as all seizure types and indicate the observed latency range.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population n=total number of seizures in each category|||seconds||Full Range|Median
1393451|NCT01325623|Secondary|Validation of Cardiac R-Wave Detection|Cardiac R‐wave detection was evaluated against concurrent ECG data (i.e. detailed R‐wave test) collected during implant, the first titration visit, at the beginning of the EMU stay, and at the 12 month visit. R‐R intervals were calculated using detected R‐waves from the Implantable Pulse Generator (IPG) and from a standard ECG monitor during a pre‐specified time interval. A time series 10 seconds was recorded using the IPG SyncPulse feature. Simultaneously, a corresponding time series over the same interval was recorded using a standard ECG monitor. The total number of beats accurately detected in the entire study population is reported.|At Implant, First Titration Visit, Day 1 EMU and 12 Months|ITT population|||percentage of beats accurately detected|||Number
1393476|NCT01325428|Secondary|Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Percentage of participants||95% Confidence Interval|Number
1393452|NCT01325623|Primary|Potential False Positives Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Potential false positive rate is defined as the sum across all patients of the total number of potential false positive detections divided by the sum across all patients of the appropriate monitoring time during the EMU stay. Data used to support the potential false positive rate analyses included digital ECG/EEG files retrieved from the EMU evaluation, corresponding M106 device downloads, and triple review results of EEG recordings.~The evaluated EMU monitoring time includes a daily 3 minutes stepping exercise during which patients stepped up and down on a step stool at a submaximal effort leve."|Epilepsy Monitoring Unit (EMU) Stay|"ITT Population: all patients implanted with Model 106 VNS Therapy System Version 2 and who have any EMU record.~10 participants analyzed for >=60% setting, 12 participants analyzed for >=40% setting, 8 participants analyzed for >=20% setting."|||Potential False Positive per Hour||95% Confidence Interval|Number
1393453|NCT01325623|Primary|Modeled Sensitivity Based on Heart Rate Increase Associated With Seizures by SDA Setting Post-Processed Through Bench-top Device Simulant|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).|||percentage of True Positive Detections||95% Confidence Interval|Mean
1393454|NCT01325623|Primary|Observed Sensitivity Based on Heart Rate Increase Associated With Seizures by Randomized SDA Setting|"Sensitivity is the total number of seizures detected divided by the total number of seizures during EMU stay.Data used to support sensitivity analyses included digital ECG/EEG files,corresponding M106 device downloads,and CRF data.Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define EEG seizure onset times.Seizure onset times were then compared with observed M106 device detections at the detection threshold setting for AutoStim that the patient was randomized to(SDA 2;60%,SDA 4;40%,SDA 6;20%).Sensitivity is only reported if the heart rate surpassed the programmed detection threshold.Number of participants is total number of subjects who had seizures during the EMU stay.~An Ictal tachycardia Seizure is a seizure with Ictal Heart rate >= 100 bpm & at least 55% increase, or 35 bpm increase from baseline) Bootstrap confidence intervals using 3000 bootstrap samples. n=total number of seizures; N= number of participants"|Epilepsy Monitoring Unit (EMU) Stay|Patients from the ITT population who completed the EMU evaluation and that had at least one reported seizure during the EMU evaluation that was confirmed by triple review; (Investigator Reported Seizures + Triple Review).|||percentage of True Positive Detections||95% Confidence Interval|Mean
1393455|NCT01325623|Primary|Summary of Seizures Reported by Investigators and Triple Review|"Subjects were admitted to the EMU and underwent standard continuous data collection of vEEG and ECG for 3 to 5 days. If a seizure occurred during the EMU stay, clinical investigators annotated the start and stop times, the type of seizure, the presumed seizure onset location, and the lobe of origin as applicable.~Following the EMU data collection phase of the trial, the de-identified, continuous electronic records (per patient) from the EMU period were provided to an independent and blinded triple review panel. This panel evaluated the EEG data and annotated seizure onset, seizure offset, and a description of seizure type. In the absence of video, seizure types could only be specified as: partial (particular type not denoted), generalized (non-absence), absence, or partial with secondary generalization."|Epilepsy Monitoring Unit Stay|ITT Population: consists of all patients implanted with the AspireSR VNS Therapy System version 2 and who have any EMU record.|||Seizures|||Number
1393456|NCT01325584|Primary|Average Improvement in ALT|Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||U/L||Full Range|Mean
1393457|NCT01325584|Primary|Average Improvement in AST|Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||U/L||Full Range|Mean
1393458|NCT01325584|Primary|Number of Patients Experiencing Adverse Events|The number of patients reporting or experiencing adverse effects will be reported.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||Participants|||Count of Participants
1393459|NCT01325584|Primary|Average Change in Alkaline Phosphatase|lab values will be summarized at baseline and as change from baseline to worst follow-up value.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.|Average Improvement in Alkaline Phosphatase|||U/L||Full Range|Mean
1393460|NCT01325584|Primary|Maximum Conjugated Bilirubin|Highest detected lab values will be summarized between baseline and end of study participation.|Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.||||mg/dl||Standard Deviation|Mean
1393461|NCT01325532|Secondary|Change in Global Sleep Scores on the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Week 3.|The Pittsburgh Sleep Quality Index (PSQI) is a patient-rated instrument to assess sleep quality and quantity and its changes throughout the study. Scoring is based on 7 individual components. Each component is scored from 0-3. Higher scores indicate worse sleep. Total global sleep score ranges from zero (0) to 21. We report here the overall change in global sleep score for each treatment arm, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of sleep disturbance (improvement), whereas a score of less than zero indicates an increase in sleep disturbance (worsening).|Baseline-Week 3|This is an intent to treat (ITT) analysis of all patients randomized.|||units on a scale||Standard Deviation|Mean
1393462|NCT01325532|Primary|Reported Side Effects Based on PRISE AE Scores|This measures the emergence of different adverse (side) effects from treatment during the study. This section will describe the most commonly reported adverse effects. The section on adverse events will describe and detail the full range of AEs reported.|Baseline-Week 3|Intent to treat sample with all subjects randomized.|||number of subjects reporting|||Number
1393463|NCT01325532|Primary|Change in Hamilton Depression Rating Scale (HAM-D 17) Score From Baseline to Week 3|The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52. This section reports the improvement in depressive symptoms during the course of treatment, i.e. the change in overall score between baseline visit and week 3 visit. Change can occur in either direction (i.e. improvement or worsening). A score of greater than zero indicates a reduction of depressive symptoms (improvement), whereas a score of less than zero indicates an increase in depressive symptoms (worsening).|Baseline-Week 3|Intent to treat sample with last observation carried forward for all randomized subject.|||units on a scale||Standard Deviation|Mean
1393464|NCT01325493|Secondary|Pain Score During Cough.|Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively||||pain score at cough||Standard Deviation|Mean
1393465|NCT01325493|Secondary|Pain Score at Rest|Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.|24, 48, 72, 96 hours post operatively||||pain score at rest||Standard Deviation|Mean
1393466|NCT01325493|Secondary|Sedation Score|"Sedation scores 0 = completely awake~= sleepy but responds appropriately~= somnolent but arouses to light stimuli~= asleep but responsive to deeper physical stimuli~= asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery."|24, 48, 72, 96 hours post operatively||||Sedation Score||Standard Deviation|Mean
1393467|NCT01325493|Primary|Morphine Equivalent Consumption (mg/kg)|Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.|at 24, 48, 72, 96 hours post operatively||||mg/kg||Standard Deviation|Mean
1393468|NCT01325428|Secondary|Progression Free Survival Over the Whole Sudy.|PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD.|From first drug administration until end of study, up to 700 days.|"TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.~TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B."|||Days||95% Confidence Interval|Median
1393469|NCT01325428|Secondary|Part B: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B.|From first drug administration until end of Part B, up to 230 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Days||95% Confidence Interval|Median
1393470|NCT01325428|Secondary|Part A: Progression Free Survival.|PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A.|From first drug administration until end of Part A, up to 713 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Days||95% Confidence Interval|Median
1393471|NCT01325428|Secondary|Part B: Duration of Unconfirmed Objective Response.|Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).|From first drug administration until end of Part B, up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Days||95% Confidence Interval|Median
1393472|NCT01325428|Secondary|Part A: Duration of Unconfirmed Objective Response.|Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).|From first drug administration until end of Part A, up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Days||95% Confidence Interval|Median
1393473|NCT01325428|Secondary|Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Percentage of participants||95% Confidence Interval|Number
1393474|NCT01325428|Secondary|Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Percentage of participants||95% Confidence Interval|Number
1393475|NCT01325428|Secondary|Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).|Objective response was defined on a patient level as a best response of CR or PR.|This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Percentage of participants||95% Confidence Interval|Number
1393541|NCT01324622|Secondary|Quality of Life Improvement Using the SF-12 Scale||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393477|NCT01325428|Primary|Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.|TRT B Treated set (Part B): All patients who received at least one dose each of Afatinib and Vinorelbine in Part B.|||Percentage of participants||95% Confidence Interval|Number
1393478|NCT01325428|Primary|Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).|Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).|This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.|TRT A Treated Set (Part A): All patients who were documented to have taken at least one dose of Afatinib in Part A.|||Percentage of participants||95% Confidence Interval|Number
1393479|NCT01325350|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Intensity units||Standard Deviation|Mean
1393480|NCT01325350|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs). A negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||mm/cm^2||Standard Deviation|Mean
1393481|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
1393482|NCT01325350|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
1393483|NCT01325350|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
1393484|NCT01325350|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs). A negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||terminal hairs/cm^2||Standard Deviation|Mean
1393485|NCT01325337|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Intensity units||Standard Deviation|Mean
1393542|NCT01324622|Secondary|Functional Improvement Using the Neck Disability Index (NDI)||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393486|NCT01325337|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||mm/cm^2||Standard Deviation|Mean
1393487|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
1393488|NCT01325337|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject’s hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
1393489|NCT01325337|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||Percentage of participants|||Number
1393490|NCT01325337|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).|Baseline, Month 6|Participants from the Modified Intent-to-Treat Population (all randomized participants who received treatment and had both Baseline and post-Baseline measurements) who had data available for this outcome measure.|||terminal hairs/cm^2||Standard Deviation|Mean
1393491|NCT01325311|Secondary|Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)||up to Day 35||||percentage of participants|||Number
1393492|NCT01325311|Secondary|Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized case data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence."|Up to day Day 35|Due to sample in Arm II one participants data was not analyzed.|||Normalized Optical Density||Standard Deviation|Mean
1393493|NCT01325311|Secondary|Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)|"The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)~This is to serve as normalized control data to determine expression of protein.~The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).~This Optical Density is based on fluorescence."|Up to Day 35||||Normalized Optical Density||Standard Deviation|Mean
1393494|NCT01325311|Secondary|Total PTH in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm I was not analyzed.|||ng/mL||Standard Deviation|Mean
1393495|NCT01325311|Secondary|Total IGFBP-3 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study.|Baseline and Up to Day 35|Due to sample one participant from Arm 1 was not analyzed.|||ng/mL||Standard Deviation|Mean
1393496|NCT01325311|Secondary|Total IGF-2 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study|Baseline and Up to Day 35|Due to sample one participant in Arm 1 was not analyzed.|||ng/mL||Standard Deviation|Mean
1393497|NCT01325311|Secondary|Total IGF-1 in Serum at Baseline and Pre-Surgery|This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study.|Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Mean
1393498|NCT01325311|Secondary|Serum Calcium Levels at Baseline and Pre-Surgery|This is a measurement of calcium in the Blood serum at baseline and at the end of the study.|Baseline and Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.|||ng/mL (absolute change)||Standard Deviation|Mean
1393499|NCT01325311|Secondary|Total PSA in Serum|This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study.|at Baseline and up to Day 35|Due to sample one participant in Arm I was not analyzed for this Outcome.|||ng/mL||Standard Deviation|Median
1393500|NCT01325311|Secondary|PBMC CYP mRNA Expression of CYP27B1|This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein.|Up to Day 35||||Ratio to Baseline||Standard Deviation|Geometric Mean
1393511|NCT01325181|Primary|Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment|number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study|12 months|All study eyes were analyzed using intention to treat principle and the last observation forward method|||participants|||Number
1393512|NCT01325181|Secondary|Change From Baseline in logMAR BCVA|the changes from baseline in logMAR BCVA throughout the follow-up period|12 months|||||||
1393513|NCT01324999|Secondary|Number of Participants With Change in WHO Functional Class (WHO FC)|The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment.|Baseline, Week 24||||participants|||Number
1393514|NCT01324999|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline, Week 8, Week 16, Week 24||||units on a scale||Standard Deviation|Mean
1393515|NCT01324999|Secondary|Short Form-36 Global Score|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best).|Baseline, Week 8, Week 16, Week 24||||units on a scale||Standard Deviation|Mean
1393516|NCT01324999|Secondary|Brain Natriuretic Peptide Level||Baseline, Week 8, Week 16, Week 24||||pg/mL||Standard Deviation|Mean
1393517|NCT01324999|Secondary|Maximum Borg Dyspnea Score During 6 Minute Walk Test|The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea.|Baseline, Week 8, Week 16, Week 24|Only 6 of the 7 study completers performed 6 minute walk test through the end of the study.|||units on a scale||Standard Deviation|Mean
1393518|NCT01324999|Secondary|Oxygen Desaturation During 6 Minute Walk Test|Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test|Baseline, Week 24|Only 6 of the 7 study completers performed the 6 minute walk test through week 24|||oxygen saturation percentage points||Standard Deviation|Mean
1393519|NCT01324999|Secondary|Resting Oxygen Saturation|Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state.|Baseline, Week 24|only 6 of the 7 study completers performed the 6 minute walk test through week 24.|||percent||Standard Deviation|Mean
1393520|NCT01324999|Primary|6 Minute Walk Distance||Baseline, Week 8, Week 16, Week 24|Only 6 of the 7 study completers performed 6 minute walk test through week 24|||meters||Standard Deviation|Mean
1393521|NCT01324947|Secondary|Time to Response Based on IMWG and Assessed by the Investigator|Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks|Includes those who had at least a partial response or better; Intent to Treat|||weeks||Full Range|Median
1393522|NCT01324947|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival was calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.|Intent to Treat population included all participants enrolled into the study|||weeks||95% Confidence Interval|Median
1393523|NCT01324947|Secondary|Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria|Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria.|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.|Includes those who had a partial response or better.|||weeks||95% Confidence Interval|Median
1393524|NCT01324947|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria|"Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG).~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.|Intent to Treat includes all participants enrolled|||weeks||95% Confidence Interval|Median
1393525|NCT01324947|Secondary|Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl)~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)~Bone marrow plasma cell percentage (absolute % ≥ 10%)~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas."|From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.|Intent to Treat included all participants enrolled.|||weeks||95% Confidence Interval|Median
1393543|NCT01324622|Secondary|Pain Scores on the Visual Analog Scale||Up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393526|NCT01324947|Secondary|Number of Participants With Adverse Events and Type of Adverse Events|"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:~Results in death;~Is life-threatening;~Requires or prolongs existing inpatient hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Constitutes an important medical event.~The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):~Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death"|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
1393527|NCT01324947|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and requires all of the following:~Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.~<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.~No increase in size or number of lytic bone lesions.~Disappearance of soft tissue plasmacytomas.~PR requires all of the following:~≥50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.~Reduction in 24-hour urinary light chain extraction by ≥90% or to <200 mg, maintained at least 42 days.~For patients with non-secretory myeloma, ≥50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to treat population includes all participants enrolled.|||percentage of participants|||Number
1393528|NCT01324947|Primary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment|"Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas."|From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.|Intent to Treat Population was defined as all enrolled participants.|||percentage of participants|||Number
1393529|NCT01324882|Primary|Intubation of Cecum|The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.|(day 1) Within time for performance of colonoscopy||||Participants|||Count of Participants
1393530|NCT01324882|Primary|Time to Intubate the Cecum|The time in seconds that it required to intubate the cecum as defined in our protocol.|The outcome was measured during the colonoscopy which was Day 1. The duration of the study was the colonoscopy on Day 1. Once the colonoscopy was finished, the study was over.||||seconds||Standard Deviation|Mean
1393531|NCT01324700|Secondary|Hamilton Rating Scale for Depression (HRSD)|The patient is rated by a clinician on 17 items that measure depressive symptom severity. The total score is calculated by summing the responses across all items. Lower scores (closer to 0) indicate the absence of depressive symptoms, while higher scores indicate the presence of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2 (0 = not present; 2 = severe). The scale range of scores is 0-52.|12 weeks||||units on a scale||Standard Deviation|Mean
1393532|NCT01324700|Primary|Asthma Control Questionnaire (ACQ)|The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|12 weeks||||units on a scale||Standard Deviation|Mean
1393533|NCT01324687|Secondary|Cost of Care|Comparison of cost of care between intervention and control groups.|Up to 36 months|The cost data was not available from the Finance Office from Rochester General Hospital or Thompson Hospital so this analysis was not performed.||||||
1393534|NCT01324687|Primary|Emergency Department Use|Use of emergency department by individuals with access to care via telemedicine as compared to those without such access to care.|Up to 42 months||||Emergency dept use rate per person-month|||Number
1393535|NCT01324622|Secondary|Extent of Spinal Canal/Cord Decompression||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393536|NCT01324622|Secondary|Sagittal Canal Diameter||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393537|NCT01324622|Secondary|Range of Motion||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393538|NCT01324622|Secondary|Sensory Deficit||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393539|NCT01324622|Secondary|Reflex Evaluation||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393540|NCT01324622|Secondary|Motor Deficit||up to 24 months|Due to the study's early termination, no data were collected for this outcome.||||Number of patients||
1393546|NCT01324622|Primary|Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate|Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))*100|12 months|Number of participants with 12-month follow-up data.|||participants with mJOA Recovery Rate ≥0|||Number
1393547|NCT01324570|Primary|Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Volume of Distribution (Vc/F)|The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the Vc/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.|Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit|The full analysis population (FAP) for PK consisted of patients who received study drug and had at least 1 valid quantifiable PK blood sample (N=41).Three patients had no quantifiable plasma buprenorphine concentration measurements and were not included in the PK analysis.The final buprenorphine pediatric PK analysis dataset comprised 38 patients.|||Liters||95% Confidence Interval|Mean
1393548|NCT01324570|Secondary|Parent/Caregiver-assessed Global Impression of Change (PGIC)|The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The PGIC score was summarized using the number and percent of patients in each of the 7 possible response categories overall and by age group. PGIC was assessed by the parent/caregiver at the end of treatment visit or early discontinuation visit.|End of treatment (week 24) or early discontinuation visit|The full analysis population (FAP) (N=40) was the group of patients who received at least 1 dose of the study drug during the study; however data was provided for only 38 patients for this outcome measure.|||Participants|||Count of Participants
1393549|NCT01324570|Secondary|Pain Right Now Assessment by Patients Aged 12 to 16 Years, Inclusive|"Pain right now was assessed using a 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked as “no pain” and the other marked as “pain as bad as it could be.” The patient was asked to make a mark on that line indicating his or her level of pain. Pain right now score was defined as the distance (in mm) from the “no pain” end to the patient’s mark; 0=no pain and bigger numbers indicate more pain. For screening to week 4, pain right now was assessed 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.~For weeks 6-24, pain right now was measured once a week at approximately 8 PM."|Up to 24 weeks|The FAP was the group of patients who received at least 1 dose of the study drug during the study.|||units on a scale||Standard Error|Mean
1393550|NCT01324570|Secondary|Pain Right Now Assessment by Patients Aged 7 to 11 Years, Inclusive|"Pain right now was assessed using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with “no hurt” at the far left and “hurts worst” at the far right; the intensities are scored as 0, 2, 4, 6, 8, or 10. A score of 0=no pain, and 10=very much pain. For screening to week 4, pain right now was assessed at 30 minutes before initial BTDS application on day 1; one hour after initial BTDS application on day 1; thereafter, once daily at approximately 8 PM for the first 4 weeks. Baseline score was the last assessment prior to the first dose. For weeks 1-4, weekly averages of the pain right now scores were calculated using the sum of all available pain right now scores recorded daily during a given week divided by the number of available scores.~The study measured pain right now for weeks 6-24 once a week at approximately 8 PM while on treatment; however, no patients in this age group were treated beyond week 12."|Up to 24 weeks|The full analysis population (FAP) was the group of patients who received at least 1 dose of the study drug during the study.|||units on a scale||Standard Error|Mean
1393551|NCT01324570|Primary|Pharmacokinetics (PK) of Buprenorphine Following Transdermal Administration: Apparent Clearance (CL/F)|The population PK (PopPK) of BTDS buprenorphine in pediatric patients ages 7 to 16 years was described by a 2-compartment model with sequential zero- and first-order absorption from the patch. A fixed allometric relationship was used to describe the effects of changes in ideal body weight (IBW) across pediatric patients on all clearance and volume parameters. Given the sparse sample collections, small sample size, and complexity of the absorption process with the patch formulation, this PopPK model was fit to the pediatric data using nonlinear mixed effects modeling (NONMEM) Bayes method with selective use of priors from previous adult PopPK results. Estimates of fixed effects from the final model were used to calculate the CL/F after patch dosing given the covariate distribution in the PopPK dataset and the typical weights from children in the National Health and Nutrition Examination Survey (NHANES) dataset.|Day 1, end of week 1, days 9/10, end of week 2, and end of week 4 or at discontinuation prior to end of study visit|The full analysis population (FAP) for PK consisted of patients who received study drug and had at least 1 valid quantifiable PK blood sample (N=41).Three patients had no quantifiable plasma buprenorphine concentration measurements and were not included in the PK analysis.The final buprenorphine pediatric PK analysis dataset comprised 38 patients.|||Liters/hour||95% Confidence Interval|Mean
1393552|NCT01324570|Primary|The Number of Participants With Adverse Events as a Measure of Safety|Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale [UMSS]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population.|Up to 28 weeks|The safety population (N=41) was the group of patients who received at least 1 dose of study drug during the study.|||Participants|||Count of Participants
1393553|NCT01324453|Secondary|Left Ventricular Remodeling (Left Ventricular End Systolic Volume - LVESV) as Measured by cMRl|LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.|baseline|There were 4 patients who did not have an LVESV measurement done, including 2 in the post conditioning + PCI group and 2 in the standard PCI group.|||mL||Inter-Quartile Range|Median
1393554|NCT01324453|Secondary|Left Ventricular Remodeling (Left Ventricular End Diastolic Volume - LVEDV) as Measured by cMRl|LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole.|baseline|There were 4 patients who did not have an LVEDV measurement done, including 2 in the post conditioning + PCI group and 2 in the standard PCI group.|||mL||Inter-Quartile Range|Median
1393555|NCT01324453|Secondary|Infarct Size by Peak Creatine Kinase (CK)||over first 72 hours post PCI|There was 1 patient who did not have a CK lab test done in the standard PCI group.|||IU/L||Inter-Quartile Range|Median
1393556|NCT01324453|Secondary|Infarct Size by Peak Troponin||over first 72 hour post PCI|There were 31 patients who did not have a troponin drawn within the specified study protocol window, including 10 in the post conditioning + PCI group and 21 in the standard PCI group.|||ng/ml||Inter-Quartile Range|Median
1393557|NCT01324453|Secondary|Global Left Ventricular Ejection Fraction||baseline||||Percent||Standard Deviation|Mean
1393558|NCT01324453|Primary|Micro Vascular Obstruction (MVO) on Baseline cMRI|High T1 imaging was utilized for the determination of the presence or absence of MVO.|Day 3-5 post-PCI|There were 8 patients in which were unable to determine the presence or absence of MVO, including 4 in the post conditioning + PCI group and 4 in the standard PCI group.|||Participants|||Count of Participants
1393559|NCT01324453|Primary|Myocardial Salvage Index (MSI) on Baseline cMRI|The myocardial salvage index (MSI) was calculated using the formula: MSI = (AAR — Infarct size) / AAR X 100 % where quantitative estimation of myocardium at risk (AAR) was measured as the hyperintense region on T2- weighted imaging. Measurements were performed using the QMass software package (Medis mc, Raleigh NC) by a single investigator who was blinded to treatment. The endocardial and epicardial borders were manually identified and the regions of interest (edema or scar) were automated as 2 standard deviations above the mean density of the myocardium.|Day 3-5 post-PCI|There were 18 patients we were unable to obtain myocardial salvage indexes for, including 10 in the post conditioning + PCI group and 8 in the standard PCI group.|||(%)||Inter-Quartile Range|Median
1393560|NCT01324453|Primary|Infarct Size on Baseline Cardiac Magnetic Resonance Imaging (cMRI)|Infarct size was quantified by delayed, contrast-enhanced MRI|Day 3-5 post-PCI|There were 12 patients whose MRI data were not usable, including 6 in the post conditioning + PCI group and 6 in the standard PCI group.|||ml||Inter-Quartile Range|Median
1393561|NCT01324440|Primary|Number of Vaccine-related Serious Adverse Experiences|"Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol:~A serious adverse event (SAE) is any AE that:~results in death,~is life threatening,~results in a persistent or significant disability/incapacity,~results in or prolongs an existing inpatient hospitalization,~is a congenital anomaly/birth defect,~is a cancer,~is an overdose,~or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above."|Up to Day 360 postvaccination|Any subject who received clinical material and had at least 1 day of safety follow-up was included in the safety summary.|||participants|||Number
1393562|NCT01324440|Primary|Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)|"Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.~The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline."|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.|||ratio of IgG titer at Day 14 to baseline||95% Confidence Interval|Geometric Mean
1393563|NCT01324440|Primary|Geometric Mean Antibody Concentrations (GMC)|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.|||mcg/mL||95% Confidence Interval|Geometric Mean
1393564|NCT01324440|Primary|Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline|Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.|Baseline and Day 14 postvaccination|The per-protocol analysis excluded patients who had missing baseline and/or postvaccination (Day 14) serology data and patients who developed a S. aureus infection during the 14 days postvaccination.|||participants|||Number
1393565|NCT01324401|Secondary|Desensitization|The consumption of 5 grams of peanut protein during an open food challenge without objective symptoms immediately post treatment|at least 36 months||||Participants|||Count of Participants
1393566|NCT01324401|Primary|Tolerance or Sustained Unresponsiveness|The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance|at least 36 months||||Participants|||Count of Participants
1393567|NCT01324388|Primary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM blood pressure data.|||millimeter of mercury (mm Hg)||Standard Deviation|Mean
1393568|NCT01324388|Primary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Metoprolol||Day -1, Day 4, Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 ABPM heart rate data.|||beats per minute (bpm)||Standard Deviation|Mean
1393569|NCT01324388|Primary|Pharmacokinetics, Maximum Concentration (Cmax) of Lisinopril||Day -1, Day 3, Day 24 in Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril Cmax data.|||(nanograms per milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
1393570|NCT01324388|Secondary|Pharmacokinetics, Maximum Concentration (Cmax) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1393571|NCT01324388|Secondary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Metoprolol When Administered With LY2189265||Day 4 and Day 7 of Treatment 2 in Part 2|Participants who received at least one dose of study drug (LY2189265 or metoprolol) with evaluable Part 2 metoprolol AUC data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1393572|NCT01324388|Secondary|Mean, 24-hour Blood Pressure (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM blood pressure data.|||millimeter of mercury (mm Hg)||Standard Deviation|Mean
1393573|NCT01324388|Secondary|Mean, 24-hour Heart Rate (Collected by Ambulatory Blood Pressure Monitoring [ABPM]) in Response to Co-administration of LY2189265 and Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable Part 1 ABPM heart rate data.|||beats per minute (bpm)||Standard Deviation|Mean
1393574|NCT01324388|Primary|Pharmacokinetics, Area Under the Concentration Curve (AUC) of Lisinopril||Day -1, Day 3, Day 24 of Part 1|Participants who received at least one dose of study drug (LY2189265 or placebo) with evaluable lisinopril AUC data.|||(nanograms*hours/milliliter)/milligram||Geometric Coefficient of Variation|Geometric Mean
1393575|NCT01324349|Secondary|Number of Subjects With Treatment-emergent Adverse Events||Up to 30 days post surgery.|All treated subjects are included in the Safety population.|||Participants|||Number
1393576|NCT01324349|Secondary|Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness and will be discussed in this report. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil).|||Participants|||Number
1393577|NCT01324349|Primary|Median Time to Achieve Hemostasis Following Application of Study Treatment.|Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (day 1)|Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil®).|||Minutes||Full Range|Median
1393578|NCT01324323|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after the last treatment)|The safety population included all subjects who received at least 1 dose of study drug.|||participants|||Number
1393579|NCT01324323|Primary|Apparent Total Volume of Distribution (Vz).|Apparent total volume of distribution (Vz) was calculated as [(CL)/λz] for Romidepsin and co-administered with Rifampin.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population was to consist of all participants who received at least 1 dose of study drug and had evaluable PK profiles.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1393580|NCT01324323|Primary|Clearance (CL): Apparent Total Plasma Clearance.|The apparent total plasma clearance (CL) was calculated as [Dose/AUC0-∞] for Romidepsin alone and co-administered with rifampin plasma concentrations.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1393581|NCT01324323|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|The terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]. This was only calculated when a reliable estimate for λz could be obtained.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||hours||Geometric Coefficient of Variation|Geometric Mean
1393582|NCT01324323|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Time to maximum observed plasma concentration (Tmax) was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||hours||Full Range|Median
1393610|NCT01323972|Secondary|Anti-hepatitis B (Anti-HB) Antibody Concentrations|Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|One month post-dose 3 (Month 3)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1393583|NCT01324323|Primary|Maximum Observed Plasma Concentration (Cmax)of Romidepsin|Maximum observed plasma concentration (Cmax)was obtained directly from the observed concentration versus time data.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1393584|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time Zero Extrapolated to Infinity (AUC0-∞).|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz]. λz is the apparent terminal rate constant. No AUC extrapolation was performed with unreliable λz. If the percentage of AUC extrapolated is ≥ 25%, AUC0–∞ will not be reported.|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The primary objective was to assess the influence of multiple doses of rifampin on the PK of romidepsin. The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1393585|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC0-24) for Romidepsin|Individual and mean romidepsin plasma concentrations by treatment and scheduled time data were collected. AUC0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 and Day 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1393586|NCT01324323|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|The PK population included all participants who received at least 1 dose of study drug and had evaluable PK profiles. The primary reason for study discontinuation for the 1 participant was due to withdrawal of consent.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1393587|NCT01324310|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|All 15 subjects in the safety population received at least 1 dose of romidepsin. AEs were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|Day 1 up to Day 36 (28 days after last treatment)|The safety population consisted of all participants who received at least 1 dose of study drug. The Day 8 analysis population included 13 participants because two participants discontinued from the study prior to Day 8 (one due to an AE, the other due to disease progression).|||participants|||Number
1393588|NCT01324310|Primary|Apparent Total Volume of Distribution (Vz)|Vz: apparent total volume of distribution, calculated as [(CL)/λz].|Days 1 and 8, At 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1393589|NCT01324310|Primary|Apparent Total Plasma Clearance (CL)|Apparent total plasma clearance, (CL) calculated as [Dose/AUC 0-∞].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1393590|NCT01324310|Primary|Estimate of the Terminal Elimination Half-life in Plasma (t1/2)|Terminal elimination half-life (t1/2) in plasma, was calculated as [(ln 2)/λz]|Days 1 and 8; at 0 (pre-dose),1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||hours||Geometric Coefficient of Variation|Geometric Mean
1393591|NCT01324310|Primary|Time to Maximum Observed Plasma Concentration (Tmax)|Tmax: time to maximum observed Tmax, obtained directly from the observed concentration versus time data|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||hours||90% Confidence Interval|Median
1393611|NCT01323972|Primary|Anti-Circumsporozoite (Anti-CS) Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.|One month post-dose 3 (Month 3)|The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1393592|NCT01324310|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax: maximum observed plasma concentration, obtained directly from the observed concentration versus time data; for Cmax, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1393593|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞: area under the plasma concentration time-curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/λz].|Days 1 and 8; at 0 (pre-dose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assess the influence of multiple doses of ketoconazole on the PK of romidepsin. The PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1393594|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to 24-hour (AUC 0-24)|AUC 0-24: area under the plasma concentration time-curve from Time 0 to 24 hours, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing; for AUC 0-24 an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% confidence interval (CI) between romidepsin alone and romidepsin in the presence of ketoconazole|Days 1 and 8; at 0 (predose), 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion|Assess the influence of multiple doses of ketoconazole on the pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1393595|NCT01324310|Primary|Area Under the Plasma Concentration Time-curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t)of Romidepsin|AUC0-t: area under the plasma concentration time-curve from Time 0 to the time of the last quantifiable concentration (Ct), calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. For AUC0-t, an analysis of variance (ANOVA) model was used to estimate the ratio of geometric means and its 90% CI between romidepsin alone and romidepsin in the presence to ketoconazole.|Days 1 and 8; at 0 (pre-dose) 1, 2, 3, and 4 hours (end of infusion) and at 4.25, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after the initiation of IV infusion.|Assessment on the influence of multiple doses of ketoconazole on the Pharmacokinetic (PK) of romidepsin; the PK population included participants who received at least 1 dose of study drug and had evaluable PK profiles. The reasons for study discontinuation: 1 subject withdrew due to an AE while another subject had disease progression.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1393596|NCT01324271|Secondary|Number of Retained (TTDS-placed) Tubes|Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.|14 days|Total in-office (IO) subjects.|||tubes|Participants||Number
1393597|NCT01324271|Primary|Percentage of Tubes Successfully Placed Using a TTDS Device|"Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.~A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with “tube.” Tube is the outcome of the device use."|Day 0|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting|||percentage of devices|Participants|95% Confidence Interval|Number
1393598|NCT01324271|Primary|Percentage of Subjects With In-office Tube Placement Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.|Day 0||||Percentage of Subjects||95% Confidence Interval|Number
1393599|NCT01324128|Secondary|Change in Serum Phosphorus Levels From Baseline to Week 12|Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.|Week 12 post Baseline|For the Secondary Outcome, data from the Per Protocol Set (PPS) was used. The PPS consists of all subjects who had completed the analysis dose titration period (baseline to Week 12), had at least 1 evaluable serum phosphorus result at or after Week 12, and had no major protocol deviations.|||mg/dL||Standard Error|Least Squares Mean
1393600|NCT01324128|Primary|Change in Serum Phosphorus Levels From Week 24 to Week 27|Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27|Week 24, Week 27|For the Primary Outcome, data from the Primary Efficacy Set (PES) was used. The PES consists of subjects who were randomized to Stage 2 and received at least 1 dose of study medication during Stage 2 and had at least 1 post-baseline (Stage 2) efficacy assessment in Stage 2.|||mg/dL||Standard Deviation|Least Squares Mean
1393609|NCT01323972|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
1393601|NCT01324102|Primary|Patient-Reported Outcomes Measurement System Scale, a Scale Developed by the National Institute of Health to Assess Outcomes Across Different Trials.|The investigators will use the Patient-Reported Outcomes Measurement System which can be found on the National Institutes of Health website. It measures changes in scale levels of Depression, Anxiety, Fatigue, Sleep Disturbance before and after the intervention. The measure is developed by National Institutes of Health to permit comparison across studies, and is reliable and valid. This is measured at baseline, and to assess for change, after the 8 week yoga intervention. There are six items in each subscale with four points each, with a range from 1-5. The full subscale range is 6-30. Anxiety was assessed by anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety); Insomnia was assessed by the anxiety subscale, ranging from 6 ( no anxiety) to 30 (worst possible anxiety).|Primary outcome is measured at baseline and after the 8 week yoga intervention.|This is a small scale pilot study. Due to small sample size, we did pre-post analysis of the total groups, separated by those with and without initial impairment.|||units on a scale||Full Range|Mean
1393602|NCT01324024|Secondary|NYU Paragraph Recall Task|Subjects hear 2 brief narratives, each containing 19-21 informational bits, and are asked to recall as many details as possible immediately after hearing each paragraph (A and B) and again following a 30 minute delay. Subjects receive credit for each informational bit recalled verbatim. Different paragraphs were read at each assessment. The maximum number of correct responses for paragraph A is 19 and the maximum number of correct responses for paragraph B is 21.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms; 16 participants in each arm. 35 total participant data was analyzed for the baseline arm.|||units on a scale||Standard Deviation|Mean
1393603|NCT01324024|Secondary|Penn Continuous Performance Test|The Penn Continuous Performance Test is a measure of visual attention and vigilance. In this task, a series of red vertical and horizontal lines flash in a digital numeric frame. The participant must press the spacebar whenever the lines form complete numbers or complete letters. The minimum to maximum score range for this task is 0-60 correct responses, with 60 being a perfect score. This data presented in the outcome measure table reflects the total number of correct responses.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms; 16 participants in each arm. 35 total participant data was analyzed for the baseline arm.|||units on a scale||Standard Deviation|Mean
1393604|NCT01324024|Primary|Brown Attention Deficit Disorder Scale (BADDS)|The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.|Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)|Of the 55 participants who were consented for screening, 20 were excluded. Of the remaining 35 subjects, 32 completed both active and placebo treatment trials. The numbers in the lisdexamphetamine and placebo arms reflect the fact that 32 subjects completed both arms. 35 total participant data was analyzed for the baseline arm.|||units on a scale||Standard Deviation|Mean
1393605|NCT01323998|Primary|Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis|The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.|4 years|Males aged 50 and older with a new pharmacy claim for AB, 5ARI or a combination of both. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram, or a procedure code for prostate surgery.|||participants|||Number
1393606|NCT01323972|Secondary|Number of Subjects With Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 8 months post-dose 1|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1393607|NCT01323972|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1393608|NCT01323972|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.|||Participants|||Count of Participants
1393708|NCT01323270|Other Pre-specified|Geometric Mean Fold-Rise (GMFR) for IgG||Before Vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.||||||
1393612|NCT01323959|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 0 – Month 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.|||Subjects|||Number
1393613|NCT01323959|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0–Day 30) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.|||Subjects|||Number
1393614|NCT01323959|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Day 0–Day 3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available and the symptom sheet filled in.|||Subjects|||Number
1393615|NCT01323959|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0–Day 3) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study booster vaccine, for whom data was available.|||Subjects|||Number
1393616|NCT01323959|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1393617|NCT01323959|Secondary|Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1393618|NCT01323959|Secondary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1393619|NCT01323959|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Above the Cut-off|Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1393620|NCT01323959|Secondary|Number of Subjects With Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)|Booster response was defined as: for initially seronegative subjects: antibody concentration ≥ 20 EL.U/mL at post booster vaccination; for initially seropositive subjects with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration at post booster ≥ 4 fold the pre-vaccination antibody concentration; and for initially seropositive subjects with pre-vaccination antibody concentration ≥ 20 EL.U/mL: antibody concentration at post booster ≥ 2 fold the pre-vaccination antibody concentration.|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1393621|NCT01323959|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in expressed in ELISA units per millilitre (EL.U/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1393622|NCT01323959|Primary|Anti-polio 1, Anti-polio 2 and Anti-polio 3 Antibody Titers|Titers are presented as geometric mean titers (GMTs).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1393623|NCT01323959|Primary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1393624|NCT01323959|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibodies|Cut-off values assessed were greater than or equal to ≥ 5 Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/ml)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1393625|NCT01323959|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1393626|NCT01323959|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1393627|NCT01323959|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody concentration greater than or equal to (≥) 8 Effective Dose 50 (ED50)|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1393628|NCT01323959|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).|At Month 1|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included subjects who met all eligibility criteria, complied with the procedures defined in the protocol, who received the booster dose of Boostrix™ Polio vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1393629|NCT01323920|Secondary|The Cumulative Incidence of Chronic GVHD Requiring Systemic Immune Suppression up to 1 Year After Stem Cell Infusion||1 year|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percentage of participants|||Number
1393630|NCT01323920|Secondary|The Non-relapse Mortality, Progression-free and Overall Survival up to 1 Year After Stem Cell Infusion|Progression free and overall survival by 1 year after stem cell infusion will be assessed using the method of Kaplan and Meier. Progression-free survival will be defined as the time from stem cell infusion to the time of disease progression or death from any cause. Overall survival will be defined as the time from stem cell infusion to the time to death from any cause. Patients will be censored at the time last documented alive. Cumulative incidence and Kaplan-Meier curves will be constructed as appropriate. Progression is defined per clinical presentation, not protocol specified, and vary per disease, e.g. blasts in bone marrow or peripheral blood for AML/MDS; lymphoma + on PET/CT re-staging etc.|1 year|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percent of participants|||Number
1393631|NCT01323920|Secondary|The Percentage Donor Engraftment up to Day 30 Post Stem Cell Infusion|To assess the percentage donor engraftment up to day 30 post stem cell infusion, defined as the first of 3 consecutive days tested of documented absolute netrophil count (ANC) >/= 500 cells/u/L|Day 30|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percentage of participants|||Number
1393632|NCT01323920|Primary|The Cumulative Incidence of Grade II-IV Acute GVHD up to Day 100 After Stem Cell Infusion|The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 100 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.|Day 100|One participant signed consent and was enrolled onto study, however, was immediately taken off study because it became evident that the participant needed further therapy and was not ready to proceed to transplant.|||Percentage of participants|||Number
1393663|NCT01323647|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (Day 0 to Month 01).|The Total Cohort, including all subjects enrolled in the study.|||Subjects|||Number
1393633|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with mild CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with mild CRI are presented, participants with severe or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure|||ng.hr/mL||95% Confidence Interval|Geometric Mean
1393634|NCT01323855|Primary|AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|One participant with moderate CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with moderate CRI are presented, participants with mild or severe CRI or their corresponding healthy matched controls were not analyzed in this outcome measure|||ng.hr/mL||95% Confidence Interval|Geometric Mean
1393635|NCT01323855|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls|Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant|Pre-dose to 48 hours post-dose|Four participants with severe CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with severe CRI are presented, participants with mild or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure|||ng.hr/mL||95% Confidence Interval|Geometric Mean
1393636|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1393637|NCT01323790|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1393638|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue – First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||hours||95% Confidence Interval|Median
1393639|NCT01323790|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of SBMs/week||Standard Error|Least Squares Mean
1393640|NCT01323790|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: “Did you feel like your bowels were completely empty after the bowel movement?” Patients provided a yes or a no response. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Percent days/week||Standard Error|Least Squares Mean
1393664|NCT01323647|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event (AE)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.|Within the 31-day follow-up period after the Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.|||Subjects|||Number
1393641|NCT01323790|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
1393642|NCT01323790|Secondary|Change From Baseline in Degree of Straining|A single-item straining question was asked via the eDiary: “How much did you strain during your bowel movement?” Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
1393643|NCT01323790|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of Days||Standard Error|Least Squares Mean
1393644|NCT01323790|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Hours||95% Confidence Interval|Median
1393645|NCT01323790|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.|||Number of patients|||Number
1393646|NCT01323790|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of patients|||Number
1393647|NCT01323777|Primary|Monocular Uncorrected Near Decimal VA|VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1393648|NCT01323777|Primary|Monocular Uncorrected Distance Decimal Visual Acuity|Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
1393649|NCT01323673|Secondary|Percent Change From Baseline in Pruritus, Stinging, Burning, and Pain Scores (Target Hand) at Days 3, 8, and 15|On Days 1, 3, 8, and 15, participants assessed the pruritis (itching), stinging (piercing pain), burning, and pain of the target hand. Participants were instructed to assess the level/severity of the indicated symptoms over the previous 24 hours using a scale ranging from 0 (none) to 10 (unbearable). Percent change from baseline was calculated as value at Days 3, 8, and 15 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Percent change in scores on a scale||Standard Deviation|Mean
1393650|NCT01323673|Secondary|Number of Participants With an SGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
1393651|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the Subject Global Assessment (SGA) (Target Hand) Score From Baseline to Days 3, 8, and 15|On Days 1, 3, 8, and 15 prior to the investigator assessment, participants rated chronic hand dermatitis of the target hand using the 5-point SGA: 0=skin is clear; 1=dermatitis in minimal, there may be a few light-pink areas; 2=dermatitis is mild, there may be occasional light-pink areas; 3=dermatitis is moderate, there may be easily noticeable pink-red areas; 4=dermatitis is severe, there may be deep or bright-red areas that may be warm to the touch.|Baseline (Day 1) and Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
1393709|NCT01323270|Other Pre-specified|Immunoglobulin G (IgG) Measured by Geometric Mean Titer (GMT)||Before vaccination 1, 1 month after Vaccination 2, 3|A decision was made, a priori, that the hSBA MnB immunogenicity assay will be used instead of the IgG assay originally planned . Therefore only hSBA assay results will be disclosed.||||||
1393652|NCT01323673|Secondary|Number of Participants With an ISGA (Target Hand) Score of 0 or 1 at Days 3, 8, and 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Days 3, 8, and 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
1393653|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 3 and and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
1393654|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 2 Grades in the ISGA (Target Hand) Score From Baseline to Day 3 and to Day 8|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1), Day 3, and Day 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
1393655|NCT01323673|Secondary|Number of Participants With an Improvement of at Least 1 Grade in the ISGA (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
1393656|NCT01323673|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) (Target Hand) Score From Baseline to Day 15|The investigator rated chronic hand dermatitis of the participants' target hand using the 5-point ISGA: 0=clear, minor residual discoloration, no erythema (redness of skin)/induration (skin hardening)/papulation (eruption of small, rounded solid bumps on skin), no oozing/crusting; 1=almost clear, trace faint pink erythema, no induration/papulation and no oozing/crusting; 2=mild, faint pink erythema, mild induration/papulation; 3=moderate, pink-red erythema, moderate induration/papulation, some oozing/crusting; 4=Severe, bright-red erythema, severe induration/papulation, oozing/crusting.|Baseline (Day 1) and Day 15|Intent-to-Treat (ITT) Population: all randomized participants who were dispensed study product. Missing values were imputed using last observation carried forward (LOCF, i.e., the last available observation, including Baseline, for a participant was used to estimate subsequent missing data points).|||participants|||Number
1393657|NCT01323660|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393665|NCT01323647|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥37.0°C). Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Grade 3 drowsiness was defined as drowsiness that prevents normal activities. Grade 3 fever was defined as fever (axillary temperature) >39.0°C. Grade 3 irritability was defined as crying more than usual/ interferes with normal activities. Grade 3 loss of appetite was defined as not eating at all. Related = symptom assessed by the investigator as related to the vaccination. This outcome measure concerns subjects only in the Poliorix Group.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.|||Subjects|||Number
1393710|NCT01323270|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level||1 month after Vaccination 3||||percentage of participants|||Number
1393658|NCT01323660|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 1.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393659|NCT01323660|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393660|NCT01323660|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393661|NCT01323660|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
1393662|NCT01323660|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 30)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Seconds||Standard Error|Least Squares Mean
1393711|NCT01323270|Secondary|Geometric Mean Titer (GMT) for Poliomyelitis Antigens||1 month after Vaccination 1||||titer||95% Confidence Interval|Geometric Mean
1393666|NCT01323647|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.|Within 4-days (Days 0-3) post Poliorix™ booster vaccination.|The Total Vaccinated cohort will include all subjects, with booster dose administration documented and for whom data are available.|||Subjects|||Number
1393667|NCT01323647|Primary|Antibody Titres Against Poliovirus Type 1, 2 and 3.|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.|Before booster vaccination.|The ATP cohort for antibody persistence included all subjects who completed their full 3-dose primary vaccination course in the primary study and who have not received an additional dose of IPV vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results are available at the persistence timepoint|||Titres||95% Confidence Interval|Geometric Mean
1393668|NCT01323647|Primary|Antibody Titres Against Poliovirus Type 1, 2 and 3|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.|||Titres||95% Confidence Interval|Geometric Mean
1393669|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.|Before booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.|||Subjects|||Number
1393670|NCT01323647|Primary|Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value|A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50. This outcome measure concerns subjects in the Poliorix Group only.|One month after Poliorix™ booster vaccination.|The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.|||Subjects|||Number
1393671|NCT01323634|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
1393672|NCT01323634|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1393673|NCT01323621|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time to onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Baseline and Day 1|ITT Population|||Minutes||Full Range|Median
1393674|NCT01323621|Primary|Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|Baseline (Day 1) and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
1393675|NCT01323595|Secondary|Bleeding Complications|We will record whether there are any bleeding complications associated with treatment after surgery.|7 days after surgery||||Participants|||Count of Participants
1393676|NCT01323595|Primary|Level of Pain|Patients will rate their pain for 7 days after surgery using an 11-point visual analog scale, ranging from 0 to 10, in which 0= no pain, 10=worst pain ever. Patients are asked to rate their pain up to four times a day during the post-operative period. Pain scores from each post-operative day each day will be averaged and reported as the pain score for that day.|1 week after surgery||||Analog pain scale||Standard Deviation|Mean
1393677|NCT01323582|Secondary|Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms are. The scale is reported in the references.~This is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change."|Baseline and end of treatment period||||units on a scale||Standard Deviation|Median
1393712|NCT01323270|Secondary|GMC for Acellular Pertussis Antigens|Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL)|1 month after Vaccination 1||||EU/mL||95% Confidence Interval|Geometric Mean
1393678|NCT01323582|Secondary|Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score.~Negative value reflects this change."|Baseline and end of treatment period|One subject did not complete this part of analysis.|||units on a scale||Standard Deviation|Mean
1393679|NCT01323582|Secondary|Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|at baseline before initiation of the treatment and after completion of each treatment period.||||minutes||Standard Deviation|Mean
1393680|NCT01323582|Secondary|Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded.|Baseline and end of treatment period||||Minutes||Standard Deviation|Mean
1393681|NCT01323582|Secondary|TLAG (Time From Ingestion of Meal to Start of Gastric Emptying)|This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)||||Minutes||Standard Deviation|Mean
1393682|NCT01323582|Secondary|NDI Score|"Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50).~For the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life.~Reference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)||||units on a scale||Standard Deviation|Median
1393683|NCT01323582|Primary|Gastroparesis Cardinal Symptom Index (GCSI) Score|"This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient’s symptoms.~Reference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50.~Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies."|Weeks 4 and 11 (end of periods)|One subject did not complete this part of analysis.|||units on a scale||Standard Deviation|Mean
1393684|NCT01323582|Primary|Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size.|Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies.|Weeks 4 and 11 (end of periods)||||Minutes||Standard Deviation|Mean
1393685|NCT01323517|Secondary|To Define the Immunologic Events and Signatures at the Tumor Site and in the Periphery That Corresponds to Response to Ipilimumab.|Summaries of antibody response, comparison of pretreatment with post-ipilimumab and end of treatment will be assessed for percent of CD4, CD8, and CD68 positive cells|2 years||||percent of positive cells||Full Range|Mean
1393686|NCT01323517|Secondary|To Determine Response Rates of Combination Therapy. Tumor Assessment Will be Measured by the Immune Related Response Criteria (irRC).|"Progression free survival, from time of ILI, will be determined by measuring the index lesions, non-index lesions, and new lesions as described below. Patients with deep lesions will have repeat CT Scan evaluation to quantitate the lesions.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|2 years||||Participants|||Count of Participants
1393687|NCT01323517|Secondary|Toxicity of Additional Ipilimumab Will be Evaluated for All Treated Patients Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0||2 years||||Participants|||Count of Participants
1393688|NCT01323517|Primary|Progression Free Survival at One Year.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year||||percentage of participants PFS at 1 year|||Number
1393705|NCT01323387|Secondary|Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.|Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.|24 Months||||Participants|||Count of Participants
1393706|NCT01323387|Primary|Number of Subjects With Successful Radiographic Fusion|CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.|24 Months||||Participants|||Count of Participants
1393689|NCT01323478|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient. Different versions of the C-SSRS are available. In this study, the Since Last Visit Version was used at all visits. In order to assess the potential relationship between Vortioxetine and suicidality more accurately and systematically, C-SSRS data were collected during the Entire Study Period.|Up to 52 weeks|Suicidal Ideation and Behaviour Based on C-SSRS Scores by Columbia Classification Algorithm for Suicide Assessment (C-CASA) - APTS|||participants|||Number
1393690|NCT01323478|Secondary|ASEX Total Score After 52 Weeks of Treatment|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Week 52|APTS, OC|||units on a scale||Standard Error|Mean
1393691|NCT01323478|Secondary|SDS Total Score After 52 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Week 52|FAS, OC|||units on a scale||Standard Deviation|Mean
1393692|NCT01323478|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Baseline and Week 52|FAS, OC|||percentage of patients|||Number
1393693|NCT01323478|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Baseline from lead-in study 13267A (NCT01140906) and Week 52|FAS, OC|||percentage of patients|||Number
1393694|NCT01323478|Secondary|Change From Baseline in HAM-A Total Score After 52 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 52|FAS, OC|||units on a scale||Standard Deviation|Mean
1393695|NCT01323478|Secondary|Change From Baseline in CGI-S Score After 52 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 52|FAS, OC|||units on a scale||Standard Deviation|Mean
1393696|NCT01323478|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|full-analysis set (FAS), observed cases (OC)|||units on a scale||Standard Deviation|Mean
1393697|NCT01323478|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS|||percentage of patients|||Number
1393698|NCT01323478|Primary|Number of Patients With Adverse Events (AEs)||Baseline to end of the 4-week safety follow-up period|all-patients-treated set (APTS)|||participants|||Number
1393699|NCT01323387|Secondary|Oswestry Disability Index (ODI) Summary|The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible|Baseline and 24 Months||||Units on a scale||Standard Deviation|Mean
1393700|NCT01323387|Secondary|SF-12 Mental Composite Score (MCS) Summary|The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months||||Units on a scale||Standard Deviation|Mean
1393701|NCT01323387|Secondary|SF-12 Physical Composite Score (PCS) Summary|The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months||||Units on a scale||Standard Deviation|Mean
1393702|NCT01323387|Secondary|Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline|The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.|Baseline and 24 Months||||Participants|||Count of Participants
1393703|NCT01323387|Secondary|Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline|The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible|24 Months||||Participants|||Count of Participants
1393704|NCT01323387|Secondary|Pain Scores on the Numeric Rating Scale (NRS)|The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain)|Baseline and 24 Months||||units on a scale||Standard Deviation|Mean
1393707|NCT01323270|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3|Summary was performed for participants as per vaccine administration.|||percentage of participants|||Number
1393715|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Scores|"Q-LES-Q-SF is a 16-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 16 items. The raw total score is transformed into a percentage maximum possible score using the following formula:(raw total score −minimum score) / (maximum possible raw score −minimum score). The minimum raw score on the Q-LES-Q-SF is 16 (worst), and the maximum score is 80 (best). A higher score indicates a better quality of life."|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Standard Deviation|Mean
1393716|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult Attention Deficit-Hyperactivity Disorder (ADHD) Rating Scales–Self Report: Screening Version (CAARS-S:SV) Score|CAARS-S:SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-S:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Standard Deviation|Mean
1393717|NCT01323192|Secondary|Clinical Global Impression of Change (CGI-C) Scores|The CGI-C is a assessment of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.|Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Full Range|Median
1393718|NCT01323192|Secondary|Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Scores|The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Full Range|Median
1393719|NCT01323192|Secondary|Mean Change From Baseline to Endpoint in the Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV) Total Score Other Than Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Score|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O: SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment.|||Scores on a scale||Standard Deviation|Mean
1393720|NCT01323192|Primary|Change From Baseline to Endpoint in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Total Attention Deficit-Hyperactivity Disorder (ADHD) Symptoms Scores of Conners' Adult ADHD Rating Scale - Observer Screening Version (CAARS-O: SV)|CAARS-O: SV evaluates DSM-IV-oriented inattention, impulsivity and hyperactivity as well as measures of self-concept. The CAARS-O:SV comprises 30 items to measure symptoms for ADHD in adults. Each item is scored from 0 (not at all, never) to 3 (very much, very frequently) with higher scores corresponding to worse symptoms. The total score can range from 0 (best) to 90 (worst). Lower score indicates improvement in ADHD symptoms.|Baseline (Day 0) to Endpoint (Week 8)|Full analysis set: All participants who received at least 1 dose of study medication; and had baseline and at least 1 post-dose efficacy assessment. One participant in the placebo group was excluded from the full analysis set because no post-dose efficacy data was available.|||Scores on a scale||Standard Deviation|Mean
1393721|NCT01323153|Secondary|Safety: Incidence of Adverse Events||24 weeks|||||||
1393722|NCT01323153|Secondary|Percent Change From Baseline in Apolipoprotein Levels||20 weeks|||||||
1393723|NCT01323153|Secondary|Percent Change From Baseline in Lipoprotein Levels||20 weeks|||||||
1393724|NCT01323153|Secondary|Percent Change From Baseline in Blood Lipid Levels||20 weeks|||||||
1393725|NCT01323153|Secondary|Percent Change of High-density Lipoprotein C (HDL-C) Treatment Levels After 8, 12 and 20 Weeks of Treatment||20 weeks|||||||
1393726|NCT01323153|Secondary|Similarity in Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment in Studies WC25501 and NC20971||4 weeks|||||||
1393727|NCT01323153|Primary|Percent Change From Baseline in High-density Lipoprotein C (HDL-C) Levels After 4 Weeks of Treatment||4 weeks||||Percentage raise in HDL-C Levels||Standard Error|Least Squares Mean
1393728|NCT01323140|Primary|Percent of Subjects With Testosterone Levels in the Normal Range.|Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (>= 300 ng/dL to <= 1030 ng/dL), at least 85% of subjects with Cmax <= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax >= 2500 ng/dL.|Day 29/30||||percentage of participants||95% Confidence Interval|Number
1393773|NCT01322594|Primary|Incidence of Clinically Significant Serum Chemistry Laboratory Results|Number of participants experiencing clinically significant serum chemistry laboratory results. A clinically significant serum chemistry laboratory result is defined as an abnormal serum chemistry laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
1393729|NCT01323010|Secondary|Admission Rates in Patients With the Arg16Gly Polymorphisms|Admission rates in patients with the Arg16Gly polymorphisms of the beta-2 adrenergic receptor (Arg16Gly, Arg16Arg and Gly16Gly genotypes).|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|The sequencing of the beta-2 adrenergic receptor gene was performed in a subset of 60 patients, in the other samples these analysis were not feasible due to hemolysis.|||participants|||Number
1393730|NCT01323010|Secondary|Admission Rates in Patients With and Without Rhinovirus Detect|Admission rates in patients with and without rhinovirus detected by PCR in nasal lavage samples.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.|||percentage of participants|||Number
1393731|NCT01323010|Secondary|Admission Rates in Patients With and Without Any Virus Detected|Admission rates in patients with and without any of the following viruses detected by PCR in nasal lavage samples: Adenovirus; Bocavirus; Coronavirus; Enterovirus (Echovirus); Influenza (A H3N2, A H1N1/2009, B and C); Metapneumovirus (subtypes A and B); Parainfluenza 1, 2, 3 and 4 (subtypes A and B); Rhinovirus; Respiratory Syncytial Virus type A and Respiratory Syncytial Virus type B.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|We obtained nasal lavage samples from 117 individuals, in two patients it was not possible to collect nasal lavage samples.|||percentage of participants|||Number
1393732|NCT01323010|Secondary|Lengths of Stay in the Emergency Room|lengths of stay in the emergency room for discharged patients|one to four hours||||hours||Inter-Quartile Range|Median
1393733|NCT01323010|Secondary|Electrocardiogram at Discharge or Hospital Admission|Electrocardiogram at discharge or hospital admission to identify possible rhythm disturbances.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|No electrocardiographic abnormalities were detected in both groups.|||participants with ECG abnormalities|||Number
1393734|NCT01323010|Secondary|Electrocardiogram One Hour Post-treatment.|Electrocardiogram one hour post-treatment to identify possible rhythm disturbances.|One hour post-treatment|No electrocardiographic abnormalities were detected im both groups|||participants with ECG abnormalities|||Number
1393735|NCT01323010|Secondary|Changes in Heart Rate at Discharge or Hospital Admission|Changes in heart rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)||||beats per minute||Standard Error|Mean
1393736|NCT01323010|Secondary|Changes in Heart Rate After One Hour|Change in heart rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline||||beats per minute||Standard Error|Mean
1393737|NCT01323010|Secondary|Changes in Pulse Oximetry at Discharge or Hospital Admission.|Changes in pulse oximetry at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.||||percentage of oxygen saturation||Standard Deviation|Mean
1393738|NCT01323010|Secondary|Change in Pulse Oximetry One Hour Post-treatment|Change in pulse oximetry one hour post-treatment in comparison with baseline|One hour post-treatment in comparison with baseline||||percentage of oxygen saturation||Standard Error|Mean
1393739|NCT01323010|Secondary|Changes in Respiratory Rate at at Discharge or Hospital Admission.|Changes in respiratory rate at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.||||breaths per minute||Standard Error|Mean
1393740|NCT01323010|Secondary|Changes in Bicarbonate Serum Levels|Changes in bicarbonate serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain bicarbonate serum levels from 42 patients in the study group and 37 in the control group (in the other samples, this analysis was not feasible due to the long time to transport the samples to the laboratory in one of our centers).|||mmol/L||Standard Error|Mean
1393741|NCT01323010|Secondary|Changes in Potassium Serum Levels|Changes in potassium serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain potassium serum levels from 54 patients in the study group and 56 in the control group (in the other samples, this analysis was not feasible due to hemolysis).|||mEq/L||Standard Error|Mean
1393742|NCT01323010|Secondary|Changes in PRAM Score at Discharge or Hospital Admission|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.~The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.~We calculated the difference between the PRAM score measured at discharge or admission and the PRAM score at baseline (PRAM score discharge or admission - PRAM score baseline).~The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).~minimum value of the difference (Albuterol - Higher Dose, experimental group): -9 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0~minimum value of the difference (Albuterol - Lower Dose, control group): -9 maximum value of the difference (Albuterol - Lower Dose, control group): 1"|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.||||units on a scale||Inter-Quartile Range|Median
1393743|NCT01323010|Secondary|Need for Additional Therapies|The need for additional therapies such as magnesium sulphate or intravenous albuterol were recorded|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|no patients received magnesium sulphate or intravenous albuterol in both groups|||participants|||Number
1393744|NCT01323010|Secondary|Changes in Respiratory Rate After One Hour|Change in respiratory rate one hour post-treatment in comparison with baseline.|One hour post-treatment in comparison with baseline||||breaths per minute||Standard Error|Mean
1393745|NCT01323010|Secondary|Electrocardiogram at Baseline|Electrocardiogram performed at baseline|at baseline|no electrocardiopraphic abnormalities were detected in both groups|||participants with ECG abnormalities|||Number
1393746|NCT01323010|Secondary|Changes in Glucose Serum Levels|Changes in glucose serum levels at discharge or hospital admission (up to 4 hours post treatment) in comparison with baseline.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment) in comparison with baseline.|It was possible to obtain glucose serum levels from 57 patients in the study group and 55 in the control group (in the other samples, this analysis was not feasible due to hemolysis).|||mg/dL||Standard Error|Mean
1393747|NCT01323010|Secondary|Albuterol Determination in the Plasma|Albuterol determination in the plasma was carried out at at discharge or hospital admission (up to 4 hours post treatment), dosage was accomplished by High Performance Liquid Chromatography.|at discharge or admission (up to 4 hours post treatment, minimum 1 hour, maximum 4 hours post treatment)|It was possible to obtain albuterol plasma levels from 52 patients in the study group and 51 in the control group (in the other samples, this analysis was not feasible due to hemolysis).|||ng/ml||Inter-Quartile Range|Median
1393748|NCT01323010|Secondary|Change in PRAM Score After One Hour|"Change in the Pediatric Respiratory Assessment Measure (PRAM) score one hour post-treatment in comparison with baseline.~The PRAM score is used to assess the severity of asthma attacks, it ranges from 0 to 15, and the higher the score, the greater the severity of the attack.~We calculated the difference between the PRAM score measured one hour post treatment and the PRAM score at baseline (PRAM score 1 hour - PRAM score baseline).~The larger the absolute value of the difference, the better the outcome (e.g., a difference of -4 indicates a better outcome that a difference of -2).~minimum value of the difference (Albuterol - Higher Dose, experimental group): -8 maximum value of the difference (Albuterol - Higher Dose, experimental group): 0~minimum value of the difference (Albuterol - Lower Dose, control group): -8 maximum value of the difference (Albuterol - Lower Dose, control group): 0"|One hour post-treatment||||units on a scale||Inter-Quartile Range|Mean
1393749|NCT01323010|Secondary|Forced Expiratory Volume in the First Second|Change in FEV1 one hour post-treatment in comparison with baseline. Spirometry was performed only in subjects older than 6 years and who could perform the maneuver properly.|One hour post-treatment in comparison with baseline||||percentage of predicted||Standard Deviation|Mean
1393750|NCT01323010|Primary|Hospital Admission|Hospital admission was defined as the need to stay in the emergency room for more than 4 hours, due to the failure to meet the discharge criteria (PRAM score ≤ 3 and pulse oximetry, ≥ 92%)|Starting at 4 hours post-treatment||||participants|||Number
1393751|NCT01322971|Secondary|Infectious Morbidity (i.e. Chorioamnionitis, Neonatal Sepsis)||up to 2 years|No data were collected for this outcome||||||
1393752|NCT01322971|Secondary|Miscarriage Rate (Loss of a Clinically Recognized Pregnancy)||up to 2 years|No data were collected for this outcome||||||
1393753|NCT01322971|Secondary|Pregnancy Rate (Pregnancy Visible on Ultrasound)||up to 2 years|No data were collected for this outcome||||||
1393754|NCT01322971|Primary|Biochemical Pregnancy Rate (Positive Pregnancy Test)|Biochemical pregnancy rate was defined as number of participants who had a positive pregnancy test|up to 2 years|No data were collected for this outcome||||||
1393755|NCT01322945|Secondary|Test-retest Reliability of the ASK Nasal Inventory|First 12 endonasal and 10 control patients enrolled in the study completed the ASK Nasal Inventory at 90 days and 120 days post surgery to measure reliablity of the survey (they scored the 9-item instrument similarly at both time frames)comparing 5-point Likert scale scores. Pearson correlation was used to determine a correlation between each patient's responses at 90 days post op and 120 days post op.|90 days and 120 days post surgery||||Correlation Coefficient|||Number
1393756|NCT01322945|Primary|Change in Mean Survey Response From Baseline to 90 Days Post Surgery|Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.|Baseline, 90 days post surgery|Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.|||units on a scale||Standard Deviation|Mean
1393757|NCT01322841|Secondary|Percentage of Patients Diagnosed With One of the Disorders||six months||||percentage of participants|||Number
1393758|NCT01322841|Primary|Percentage of Patients Screened Positive for One of the Disorders||six months||||percentage of participants|||Number
1393759|NCT01322815|Primary|Number of Participants Alive and Free of Progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients)|Clinical benefit rate is defined as the proportion of patients alive and free of progression at 4 Months (Patients Who Have Undergone Prior Therapy) and 10 Months (Untreated Patients), assessed from first treatment with GI-4000. Progression is defined as CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of the target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of the target lesions; or SD (stable disease) = small changes that do not meet the above criteria.|4 Months for patients who had undergone prior 1st-line therapy, and 10 months for previously untreated patients|Patients with RAS mutant positive metastatic colorectal cancer (CRC), either newly diagnosed, or having completed first line therapy with an oxaliplatin or irinotecan plus fluoropyrimidine and bevacizumab containing regimen.|||participants|||Number
1393771|NCT01322594|Secondary|Area Under the Serum Concentration-Time Profile From Time Zero to the Last Measurable Time Point|Area under the serum concentration-time profile from time zero to the last measurable time point of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||ng x day/mL||Standard Deviation|Mean
1393772|NCT01322594|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinity|Area under the serum concentration-time curve from time zerio to infinity of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||ng x day/mL||Standard Deviation|Mean
1393760|NCT01322633|Secondary|Incidence Rate of Overall Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of any type of cancer (excluding non-melanoma skin cancers), death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of any cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.|||incidence per 100000 person-years||95% Confidence Interval|Number
1393761|NCT01322633|Secondary|Incidence Rate of Composite Gastrointestinal Cancers|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of cancer of colon, pancreas, liver or small intestine, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastrointestinal cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.|||incidence per 100000 person-years||95% Confidence Interval|Number
1393762|NCT01322633|Primary|Incidence Rate of Gastric Cancer|Incidence rate was expressed as cases per 100,000 person-years with 95 percent (%) confidence intervals. Incidence rates were estimated from 1 year after the index date and were censored at the earliest of following events: diagnosis of gastric cancer, death, withdrawal from KPNC membership or end of the study, whichever occurred first for pantoprazole group. For other PPI group, data was also censored in case participants switched to pantoprazole group. Index date: the earliest date at which participant had achieved 240 days of study drug exposure within a 12 month time period before the study start date. Person-year was estimated by calculating all of the years that participants in a study were followed. Person-year calculations were adjusted for anticipated mortality based on United States (US) life tables.|1 year after index date up to diagnosis of gastric cancer, death, withdrawal from KPNC membership, date when other PPI participants switched to pantoprazole or end of the study (up to Year 7.5)|Analysis population included all participants who met the inclusion criteria.|||incidence per 100000 person-years||95% Confidence Interval|Number
1393763|NCT01322607|Secondary|Balance|Dynamic Gait Index - another measure related to balance and general function. It includes items of walking while changing speed, turning the head, pivot turning, walking over and around obstacles, and stair climbing. This index ranges from 0 - 24, with 24 representing a high level of balance and general function (the higher the score the better the balance).|3 months||||units on a scale||Standard Deviation|Mean
1393764|NCT01322607|Secondary|Muscular Endurance|Muscular endurance performed on Leg Press and assessed by a force transducer, while seated. The longer the amount of time participant can maintain a force the better their muscular endurance.|3 months||||seconds||Standard Deviation|Mean
1393765|NCT01322607|Secondary|Muscular Strength|Strength measured by torque of isokinetic maximal concentric knee extensor volitional contractions of paretic and non-paretic leg at multiple angular velocities (30, 90, and 120°/sec). The higher the number the higher the muscular strength. Also performed on resistance equipment for both the Leg Press and Leg Extension. The higher the number the stronger a person is.|3 months||||newtons (N)||Standard Deviation|Mean
1393766|NCT01322607|Primary|Economy of Gait|Over-ground gait economy measured using a portable metabolic monitoring system, K4b2 during a 6 minute walk, with subjects walking at their comfortable self-selected walking speed while open circuit spirometry collects break-by-break data. The K4b2 consists of a small battery pack and portable gas analyser (weighing less than 1 kg) that participants wear on their chest. Attached to the portable system is a flexible rubber facemask with flowmeter used for breath-by-breath analysis. The mean rate of oxygen consumption (VO2) will be calculated based on the final 3 minutes of a 6-minute walk under steady state oxygen consumption conditions. A 6 minute walk is a distance most representative of community-based ambulatory capacity and is a sensitive outcome measure in exercise studies in chronic stroke subjects. The higher the VO2 used during the 6 minute walk, represents a less efficient economy of gait.|3 months||||ml/kg/min||Standard Deviation|Mean
1393767|NCT01322594|Secondary|Clearance (CL)|CL of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||L/Days||Standard Deviation|Mean
1393768|NCT01322594|Secondary|Apparent Terminal Elimination Phase Half-life (t1/2)|t1/2 of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||Days||Standard Deviation|Mean
1393769|NCT01322594|Secondary|Observed Maximum Concentration (Cmax)|Cmax of MEDI2338|Pre-dose (Day 1) and post-dose (Days 1 [end of infusion, and 30 minutes and 1, 3, 8, and 24 hours postinfusion], 2, 3, 5, 8, 10, 15, 22, 29, 36, 43, 57, 71, and 92)|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the pharmacokinetic analysis|||ng/mL||Standard Deviation|Mean
1393770|NCT01322594|Secondary|Incidence of Anti-drug Antibodies (ADA) to MEDI2338|Number of participants with ADA to MEDI2338|Days 1, 57, and 92|Of the 31 participants who entered into the study and received MEDI2338 or placebo, 25 participants received only MEDI2338 and were included in the analysis of ADA|||Participants|||Number
1393774|NCT01322594|Primary|Incidence of Clinically Significant Vital Signs Results|Number of participants experiencing clinically significant vital signs results. A clinically significant vital signs result is defined as an abnormal vital signs result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
1393775|NCT01322594|Primary|Incidence of Clinically Significant Electrocardiogram Results|Number of participants experiencing clinically significant electrocardiogram results. A clinically significant electrocardiogram result is defined as an abnormal electrocardiogram result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
1393776|NCT01322594|Primary|Incidence of Clinically Significant Hematology Laboratory Results|Number of participants experiencing clinically significant hematology laboratory results. A clinically significant hematology laboratory result is defined as an abnormal hematology laboratory result that results in a treatment-emergent adverse event.|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
1393777|NCT01322594|Primary|Incidence of Serious Adverse Events|Number of participants experiencing serious adverse events|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
1393778|NCT01322594|Primary|Incidence of Adverse Events|Number of participants experiencing adverse events (includes both adverse events and serious adverse events)|Days 1 - 92|All 31 participants entered into the study received MEDI2338 or placebo and were included in the analysis|||Participants|||Number
1393779|NCT01322386|Primary|Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia|Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia through improvement of Liver function tests (LFTs) within 3 months of initiating therapy. In addition for PSC, we looked at 25% reduction of abnormal ALT & GGT, reduction in biliary strictures and beading, and reduction of inflammation in liver biopsies and colon biopsies.|Within 3 months of therapy|Ten BA participants had surgery (Kasai portoenterostomyprocedure) at 1 week before starting the Vancomycin so we could not determine if they benefited from the therapy. On oral vancomycin, 9 PSC patients had improvement of LFTs, 8 had improvement of liver biopsies and/or MRI, and colon biopsies,and 1 pt. refused to have these additional studies.|||participants|||Number
1393780|NCT01322360|Secondary|Number of Subjects Who Experienced Adverse Events of Moderate to Severe Intensity / Grade|Subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade|Up to 21 days||||participants|||Number
1393781|NCT01322360|Primary|Number of Subjects Who Experienced Adverse Events That Led to Study Discontinuation|"The primary safety endpoints were the percentage of subjects who experienced any AEs that led to study discontinuation, percentage of subjects with SAEs and those with a sedation score of 4. Secondary safety endpoints included the percentage of subjects who experienced any AEs of special interest, which included sedation, respiratory depression, nausea, vomiting, and pruritus of moderate to severe intensity/grade.~Additional secondary endpoints were the incidence, type, relationship to study drug, and severity of AEs, and the percentage of subjects with clinically significant decreases in SpO2 and respiratory rate, as assessed by the investigator."|Up to 21 days|75 subjects were screened and 50 subjects took at least one dose of oral morphine sulfate.|||participants|||Number
1393782|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.|||grams per liter||Standard Deviation|Mean
1393783|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
1393784|NCT01322347|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured.|||grams per liter per week||Standard Deviation|Mean
1393785|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||percentage||Standard Deviation|Mean
1393786|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
1393787|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||micrograms per liter||Standard Deviation|Mean
1394020|NCT01318694|Secondary|Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks|ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).|at treatment end within 48 weeks|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
1393788|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||picograms||Standard Deviation|Mean
1393789|NCT01322347|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
1393790|NCT01322347|Secondary|Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percentage of change from baseline||Standard Deviation|Mean
1393791|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects|||units of red blood cells or whole blood|||Number
1393792|NCT01322347|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|Up to 48 weeks from date of randomization|intent-to-treat: all randomized subjects|||participants|||Number
1393793|NCT01322347|Secondary|Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromole per liter||Standard Deviation|Mean
1393794|NCT01322347|Secondary|Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percent||Standard Deviation|Mean
1393795|NCT01322347|Secondary|Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
1393796|NCT01322347|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.|Hgb measured weekly; up to 48 weeks from date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.|||grams per liter||Standard Error|Least Squares Mean
1393797|NCT01322048|Secondary|Plasma Norepinephrine Levels||Post-treatment (t=Day 8)|Of those surviving treatment period|||pg/mL||Inter-Quartile Range|Median
1393798|NCT01322048|Primary|Ventilator-free Days||Baseline to day 28||||days||Inter-Quartile Range|Median
1393799|NCT01322022|Primary|Actigraphy - Sleep Latency|Measure of sleep latency defined by the time from lights off to sleep onset.|Baseline, Week 4, Week 8||||minutes||Standard Deviation|Mean
1393800|NCT01322022|Primary|Actigraphy - Sleep Efficiency|Measure of sleep efficiency defined as the percentage of time sleeping while in bed with lights off|Baseline, Week 4, Week 8||||Percentage of Time Sleeping||Standard Deviation|Mean
1393801|NCT01322022|Secondary|Actigraphy - Total Sleep Time|Measure of total time spent asleep using Motionlogger model actigraph by Ambulatory Monitoring, Inc. (www.ambulatory-monitoring.com) and algorithms in associated software.|Baseline, Week 4, Week 8||||minutes||Standard Deviation|Mean
1394021|NCT01318694|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment|eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.|from 4 to 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
1393802|NCT01322022|Primary|Modified Simond & Parraga Sleep Questionnaire (MSPSQ) - Composite Sleep Index|The MSPSQ used by Wiggs and colleagues (Wiggs & Stores, 1996 ; Wiggs & Stores, 1999 : Wiggs & Stores, 2004) was used to assess the child's sleep quality. It was completed by the primary caregiver for both groups at baseline and at weeks 4 and 8. Using Wiggs & Stores earlier-described conventions for determining the Composite Sleep Index (CSI) score, the CSI was calculated by assigning a score to the frequency of the targeted sleep problems: bedtime resistance, night awakening, early awakening, and sleeping in places other than bed. In addition, scores were assigned for the duration of sleep latency and night awakenings. The total CSI score ranged from 0 to 12, with higher scores indicating more severe bedtime and sleep patterns.|Baseline, Week 4, and Week 8||||units on a scale||Standard Deviation|Mean
1393803|NCT01322009|Secondary|Antioxidant Reserve|Antioxidant reserves in CSF and serum will be calculated in both treatment arms and compared.|Within 5 days of injury||||reactive oxygen species scavenged||Standard Error|Mean
1393804|NCT01322009|Primary|Number of Participants Who Experienced Adverse Events|"The number of patients experiencing one or more of the following adverse events:~Acute renal failure Anaphylaxis Acute respiratory distress syndrome Intracranial infection/abscess Arrhythmia, atrial Arrhythmia, ventricular Bradycardia Cardiac arrest Catheter positive culture Cerebrospinal fluid leak Decubitis Deep vein thrombosis Diabetes Insipidus Emesis Extraaxial hematoma Gastrointestinal bleed Gastritis Hematuria Hemorrhage, other Hemoperitonium Hemothorax Hepatitis Hydrocephalus Hypotension Hypoxemia Infection, other Intraparenchymal hemorrhage Intraventricular hemorrhage Meningitis/ventriculitis Multiorgan dysfunction syndrome Myocardial ischemia Pancreatitis Pericarditis Peritonitis Pneumothorax Pulmonary edema Pulmonary embolism Respiratory arrest Seizures Sepsis Syndrome of inappropriate antidiuretic hormone Transtentorial herniation Withdrawal of Life Support Other SAE causing re-hospitalization Other SAE"|14 days after drug administration||||participants|||Number
1393805|NCT01321749|Secondary|Brain Perfusion Improvement Are Evaluated With SPECT and TCD|Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection.|300-day after treatment|||||||
1393806|NCT01321749|Secondary|The Time Point Until the First Stroke Recurrence,|These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.|At the 300-day after the initial treatment|||||||
1393807|NCT01321749|Primary|Number of Patients Who Got New Brain Lesions|We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)|300 days after treatment||||participants|||Number
1393808|NCT01321749|Primary|Plasma Biomarkers of Coagulation and Fibrinolysis|blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer|the time points of baseline and 1, 15 and 30 days after BLIPC treatment|||||||
1393809|NCT01321749|Primary|Blood Pressure and Heart Rates;||at the time points of baseline and 1, 15 and 30 days after BLIPC treatment|||||||
1393810|NCT01321723|Secondary|% Change From Baseline in Bone Formation Marker (P1NP) at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.|||percentage of change||Standard Deviation|Mean
1393811|NCT01321723|Secondary|Systemic Absorption of PTH at Week 24|AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)|24 weeks||||pg* hr/mL||Standard Deviation|Mean
1393812|NCT01321723|Secondary|% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24|Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.|24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.|||percentage of change||Standard Deviation|Mean
1393813|NCT01321723|Post-Hoc|Number of Participants With AEs as a Measure of Safety and Tolerability||24 weeks|Overall Summary of Adverse Events - Each subject with an event is counted only once although they may have several events.|||participants|||Number
1393814|NCT01321723|Primary|% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24||24 weeks from baseline|mITT Population: all subjects who received at least one dose of treatment and at least one post-baseline BMD value. Missing data imputation for patients who completed Week 12 but not the full 24-week period, data was imputed using the LOCF. No data imputation was performed for Week 24, if the Week 12 data was missing.|||percentage of change||Standard Deviation|Mean
1393815|NCT01321710|Primary|Change in Infant Sleep Quantity (Objective)|Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.|24 hours before and 24 hours after immunizations at approximately 2 months of age|ITT analysis. Infants who were not immunized or did not have valid outcome data were excluded from the analysis.|||minutes||Standard Deviation|Mean
1393816|NCT01321710|Secondary|Maternal Well-being|Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.|1 month postpartum (approximately)|ITT analysis.|||Scores on a scale||Standard Deviation|Mean
1393817|NCT01321710|Secondary|Maternal Sleep Disturbance (Subjective)|Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.|1 month postpartum (approximately)|ITT analysis.|||Scores on a scale||Standard Deviation|Mean
1394022|NCT01318694|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment|cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
1393818|NCT01321710|Primary|Maternal Sleep Quality (Objective)|Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.|1 month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.|||percentage of sleep per time in bed||Standard Deviation|Mean
1393819|NCT01321710|Primary|Maternal Sleep Quantity (Objective)|Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.|1-month postpartum (approximately)|ITT analysis. Because this was a repeated measures analysis at 1 and 3 months postpartum, subjects missing outcome data at either point were excluded from the analysis.|||hours||Standard Deviation|Mean
1393820|NCT01321697|Primary|Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.||at time of surgery|Data were not collected/analyzed due to study termination.||||||
1393821|NCT01321606|Secondary|Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells|This outcome is the mean difference in the % of monocytes that phagocytized E. coli, from blood samples taken at the beginning and end of the trial. Percent of monocytes phagocytizing E. coli at baseline is subtracted by percent of monocytes phagocytizing E. coli at the end of the trial. The mean and standard error are calculated and reported for each study arm.|4 weeks|Some participants were excluded from this analysis due to lack of sample collection, or unusable results because tests did not meet acceptability criteria.|||Difference in % POS of Monocytes||Standard Error|Mean
1393822|NCT01321606|Secondary|Oral L. Rhamnosus HN001 Therapy Compared With Placebo on Phagocytic Functioning of Polymorphonuclear (PMN) and Monocyte Cells|This outcome is the mean difference in the % of granulocytes that phagocytized E. coli, from blood samples taken at the beginning and end of the trial. Percent of granulocytes phagocytizing E. coli at baseline is subtracted by percent of granulocytes phagocytizing E. coli at the end of the trial. The mean and standard error are calculated and reported for each study arm. This result|4 weeks|Some participants were excluded from this analysis due to lack of sample collection, or unusable results because tests did not meet acceptability criteria.|||Difference in % POS of Granulocytes||Standard Error|Mean
1393823|NCT01321606|Primary|Oral L. Rhamnosus HN001 Therapy Compared to Placebo on Gastrointestinal and Extra-gastrointestinal Colonization of S. Aureus.|Participants in the final outcome may be colonized at both GI and Extra-GI sites, thus the total numbers from the outcome cells can be greater than the overall number of participants analyzed.|4 weeks||||Participants|||Count of Participants
1393824|NCT01321554|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve|AUC was used to determine the total exposure of lenvatinib in blood plasma. From each participant, a total of up to 12 blood samples were collected at the following specified time points: predose, 0.5 to 4 hours postdose, and 6 to 10 hours postdose on Cycle 1/Day 1 and Cycle 1/Day 15; predose and 2 to 12 hours postdose on Cycle 2/Day 1; and predose only on Day 1 of Cycles 3 to 6. The samples were analyzed for the concentration of lenvatinib using validated analytical methods. Population PK model and observed concentration data were used to derive model-predicted lenvatinib PK parameters and lenvatinib exposure (AUC) based on the 24 mg starting dose.|Cycle 1 Day 1 through Cycle 6 Day 1|PK Analysis Set - All the subjects who received at least one dose of study drug and had evaluable PK data|||ng*h/mL||Full Range|Median
1393825|NCT01321554|Secondary|Overall Survival (OS)|Overall survival measured from the date of randomization until date of death from any cause. Overall survival is adjusted with rank preserving structural failure time.|Date of randomization until date of death from any cause, assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set|||months||95% Confidence Interval|Median
1393826|NCT01321554|Secondary|Overall Response Rate (ORR)|ORR, defined as the proportion of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by MRI/CT scans (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1393827|NCT01321554|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression or death (whichever occurred first), as determined by blinded independent imaging review (IIR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for the double-blind treatment period (Randomization Phase). Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions.|Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years|Full Analysis Set (Intent-to-Treat Analysis Set) included all randomized subjects.|||months||95% Confidence Interval|Median
1393828|NCT01321073|Primary|Rate of Catheter-related Complications Per 1000 Patient Days|A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint.|Implant to 2 years|All days of follow-up for implanted patients|||complications per 1000 patient-days|Patient days||Number
1393829|NCT01321008|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.|Day 1 to disease progression or death (up to 5+ years)|Study terminated early, no analysis available.||||||
1393830|NCT01320943|Secondary|Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms|HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.|Week 96|HBsAg Loss and Seroconversion Full Analysis Set|||Proportion of participants||95% Confidence Interval|Number
1393831|NCT01320943|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF)||Baseline to Week 144|Participants in the Full Analysis Set with available data were analyzed. Percentages are based on the number of participants with non-missing laboratory test results at each visit. One participant restarted TDF during Weeks 72 and 120 and thus was reported in both the Stop TDF and Re-Start TDF groups based on the date of TDF restart.|||Percentage of participants|||Number
1393832|NCT01320943|Secondary|Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups)|Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.|Baseline to Week 144|Participants in the FAS with available data were analyzed. When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. 1 participant restarted TDF during Wk 72, thus was reported in both Stop TDF and Restart TDF arms based on the TDF restart date.|||Percentage of participants|||Number
1393833|NCT01320943|Secondary|Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm||Weeks 48, 96, and 144|Full Analysis Set (FAS): participants who were randomized to Stop TDF group and had a baseline visit or who were randomized to Continue TDF group and received at least 1 dose of study drug. Proportions are based on the Kaplan-Meier estimate.|||Proportion of participants||95% Confidence Interval|Number
1393834|NCT01320943|Secondary|Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms|"The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF~When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF."|Baseline to Week 144|Participants in the Full Analysis Set ( participants who were randomized to Stop TDF arm and had a baseline visit or who were randomized to Continue TDF arm and received at least 1 dose of study drug) with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1393835|NCT01320943|Secondary|Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144|HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.|Weeks 96 and 144|HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least 1 post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.|||Proportion of participants||95% Confidence Interval|Number
1393836|NCT01320943|Primary|Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms|HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.|Week 144|HBsAg Loss and Seroconversion Full Analysis Set: participants in the Full Analysis Set who had at least one post-baseline HBsAg value and with HBsAg positive and HBsAb negative or missing at baseline.|||Proportion of participants||95% Confidence Interval|Number
1393837|NCT01320826|Primary|Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."|[When pathology from colonoscopy available (on average 2-3 weeks after procedure)]|For this outcome, we only examined females ≥ 50 years old having their first colonoscopy|||percentage of females||95% Confidence Interval|Mean
1393838|NCT01320826|Secondary|Percentage of Patients Referred to a Specialist.|The percentage of patients who are anticipated to be referred to specialists, for the gastrointestinal complaint for which the colonoscopy was performed will be determined and the reason for referral will be tabulated. The referral percentage will be determined both from the time of colonoscopy (physician reported) and from the patient satisfaction phone survey (patient reported).|Within four (4) weeks of colonoscopy||||percentage of patients|||Number
1393839|NCT01320826|Secondary|Colonoscopy Procedure Time|Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.|At time of colonoscopy (DAY 1 of study)||||minutes||95% Confidence Interval|Mean
1393840|NCT01320826|Secondary|Patient Satisfaction With Hospital Experience for Colonoscopy|"Patient satisfaction with their hospital experience during their colonoscopy will be recorded by using a 7 point Likert scale at the time of the patient satisfaction phone survey.~7 = extremely satisfied~1 = extremely dissatisfied~Minimum score = 1 Maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients consented to and completed the post procedural satisfaction survey.|||units on a scale||Inter-Quartile Range|Median
1393841|NCT01320826|Secondary|Patient Satisfaction With Endoscopy Wait Time|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied~minimum score = 1 maximum score = 7"|At patient satisfaction phone survey (on average 4 weeks after colonoscopy)|443 patients completed the post procedural satisfaction survey.|||units on a scale||Inter-Quartile Range|Median
1393842|NCT01320826|Secondary|Patient Comfort During Colonoscopy|"To determine the patients' comfort level during the colonoscopy, a five-item question used by the Joint Advisory Group on Gastrointestinal Endoscopy in the United Kingdom will be used.~Patient discomfort on the 5 point scale:~0 is no discomfort;~is one or two episodes of discomfort, well tolerated;~is more than two episodes of discomfort adequately tolerated;~is significant discomfort experienced several times during the procedure;~is extreme discomfort experienced frequency throughout the procedure.~Minimum value = 0, maximum value = 4 with 4 being worse."|At time of colonoscopy (DAY 1 of study)||||units on the scale||Standard Deviation|Mean
1393843|NCT01320826|Secondary|Colonoscopy Withdraw Time in Cases Where no Lesions Found|Withdrawal time will be defined as the time from leaving the cecum until the colonoscope exits the anus. This will be calculated for cases in which no lesions were found.|At time of colonoscopy (DAY 1 of study)|Only examined patients in which no lesions were detected.|||minutes||95% Confidence Interval|Mean
1394023|NCT01318694|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment|pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
1393844|NCT01320826|Secondary|Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.~Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).~All potential serious complications of colonoscopy will be externally adjudicated."|Within four (4) weeks of colonoscopy||||patients undergoing colonoscopy|||Number
1393845|NCT01320826|Primary|Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|We only examined this outcome for males 50 years and older having their first colonoscopy|||percentage of males||95% Confidence Interval|Mean
1393846|NCT01320826|Primary|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.|When pathology from colonoscopy available (on average 2-3 weeks after procedure)|Number of patients who underwent colonoscopy|||adenomas / colonoscopy||95% Confidence Interval|Number
1393847|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Adjusted)|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)|At time of colonoscopy (DAY 1 of study)||||percentage of colonoscopies attempted||95% Confidence Interval|Number
1393848|NCT01320826|Primary|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100|At time of colonoscopy (DAY 1 of study)|Prospective, observational study, all study participants were analyzed|||percentage of colonoscopies performed||95% Confidence Interval|Number
1393849|NCT01320735|Secondary|Median Percentage of Time Off-treatment During 2 Years IAD Regimen|The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.|||Percentage of time off-treatment||Full Range|Median
1393850|NCT01320735|Primary|Number of Participants Who Switched to IAD Regimen by Visit|The data are reported as number of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Participants|||Number
1393851|NCT01320735|Secondary|Mean Duration of Treatment-off Time in IAD Regimen|Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin [cycle N+1] minus last dose date [cycle N] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from participants who started IAD.|||Months||Standard Deviation|Mean
1393852|NCT01320735|Primary|Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen|The data are reported as percentage of participants.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Percentage of participants|||Number
1393853|NCT01320735|Other Pre-specified|Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.|||Participants|||Number
1393854|NCT01320735|Other Pre-specified|Number of Participants Who Received IAD Regimen During the Study|The data are reported as number of participants.|24 months|Data are of measurements collected from participants who started IAD.|||Participants|||Number
1393855|NCT01320735|Secondary|Median Survival Time|Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Participants who died while on study were used for analysis.|||Months||Full Range|Median
1393856|NCT01320735|Secondary|Median Time to Progression of HRPC in Participants Not Started on IAD Regimen|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements of participants who did not start on IAD regimen.|||Months||95% Confidence Interval|Median
1393857|NCT01320735|Secondary|Median Time to Progression of HRPC|Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.|||Months||Full Range|Median
1393858|NCT01320735|Primary|Median Number of Leuprorelin Cycles|The Participants were on IAD regimen and the data are reported as number of cycles with full range.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. However, one participant started continuous hormone therapy and was not included in the analysis.|||Cycles||Full Range|Median
1397742|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48||Baseline, 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||millimeter^3 (mm^3)||Standard Deviation|Mean
1393859|NCT01320735|Secondary|Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)|Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.|Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit|Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.|||Participants|||Number
1393860|NCT01320735|Primary|Mean Duration of Each Leuprorelin Cycle|Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Months||Standard Deviation|Mean
1393861|NCT01320735|Primary|Mean Duration of Leuprorelin Exposure|Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.|24 months|Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.|||Months||Standard Deviation|Mean
1393862|NCT01320735|Other Pre-specified|Duration of IAD Regimen Induction Phase|Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.|At least 6-9 months after Baseline (enrollment)|Data are of measurements collected from participants who started IAD.|||Months||Standard Deviation|Mean
1393863|NCT01320722|Secondary|Mean 24-Hour Ambulatory Blood Pressure (ABP) Nocturnal Dipping|A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours. Nocturnal dipping is the percent change lower between the daytime and nighttime values.|Baseline and Week 8|All randomized enrolled participants with complete 24-hour ABP data available for analysis.|||percent change||Standard Deviation|Mean
1393864|NCT01320722|Secondary|Mean 24-Hour Ambulatory Blood Pressure (ABP)|A 24-hour mean ambulatory blood pressure was monitored using a 24 hour ABP device. The ABP device is a small box that is worn on the belt or pant/skirt line with a line that connect under the clothing to the cuff on the upper arm. Blood Pressure was recorded every 30 minutes during the day and every 60 minutes during the night for 24 hours.|Baseline and Week 8|All randomized enrolled participants with complete 24-hour ABP data available for analysis.|||mmHg||Standard Deviation|Mean
1393865|NCT01320722|Secondary|Change in Endothelium-Dependent Vasodilation (EDV)|Endothelial function was assessed by EDV using brachial artery ultrasonography. Measurements of brachial artery diameter were made under basal conditions and reactive hyperemia following ischaemic stimulus. A blood pressure cuff on the forearm was pumped up for 5 minutes then released. Images were taken at baseline and after reactive hyperemia (increased blood flow). The maximum diameter was determined by the investigator. Change in EDV was expressed as a percent of brachial luminal diameter calculated as post-ischaemic brachial artery diameter - pre-ischaemic brachial artery diameter/pre-ischaemic brachial artery diameter * 100.|Baseline and Week 8 (pre and post ischaemic stimulus)|All randomized enrolled participants.|||percent of brachial luminal diameter||Standard Deviation|Mean
1393866|NCT01320722|Primary|Angiotensin II (ATII) Concentration [Uric Acid]|ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants with data available for analysis.|||pg/mL||Inter-Quartile Range|Median
1393867|NCT01320722|Primary|Plasma Renin Activity (PRA) [Uric Acid]|PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants with data available for analysis.|||ng/mL per hour||Inter-Quartile Range|Median
1393868|NCT01320722|Primary|Change in Renal Plasma Flow (RPF) Response to Captopril in High Sodium Balance [Uric Acid]|RPF in response to captopril iis a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.|Week 8 (pre and post captopril)|All randomized enrolled participants with data available for analysis.|||mL/min per 1.73 m^2||Inter-Quartile Range|Median
1393869|NCT01320722|Primary|Angiotensin II (ATII) Concentration [Vitamin D]|ATII concentration is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma ATII was analyzed using a double-antibody radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants included in the analysis.|||pg/mL||Standard Deviation|Mean
1393870|NCT01320722|Primary|Plasma Renin Activity (PRA) [Vitamin D]|PRA is a measure of systemic renin angiotensin system (RAS) activation. Blood was collected and plasma PRA was analyzed using a competitive binding radioimmunoassay (RIA) laboratory test.|Week 8|All randomized enrolled participants included in the analysis.|||ng/mL per hour||Standard Deviation|Mean
1393871|NCT01320722|Primary|Change in Renal Plasma Flow (RPF) in Response to Captopril in High Sodium Balance [Vitamin D]|Change in RPF in response to captopril is a measure of the vasodilator effect from inhibiting angiotensin II (AngII)- mediated vascular tone and therefore the degree of kidney specific Renin Angiotensin System (RAS) activity. Participants consumed a high sodium diet 3 days prior to the test. Following an 8 hour fast, participants remained in a supine (lying down) position and had an intravenous (IV) catheter inserted in each arm, one for infusion and one for blood collection. An 8 milligrams (mg)/kilogram(kg) loading dose of para-aminohippuric acid (PAH) was given, immediately followed by a continuous PAH infusion at 12 mg/minute. After 60 minutes a single dose of 25 mg of captopril was administered. Three pre-captopril measurements and three post-captopril measurements of RPF were made. RPF was normalized to body surface area of 1.73 meters squared (m^2). The change in RPF was calculated as post-captopril RPF- pre-captopril RPF.|Week 8 (pre and post captopril)|All randomized enrolled participants included in the analysis.|||mL/min per 1.73 m^2||Standard Deviation|Mean
1393872|NCT01320683|Secondary|Overall Survival|Overall Survival is calculated for all patients from the date of initial treatment to date of death due to any cause. Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method, and 95% confidence limits calculated for these estimates.|Up to 5 years|||||||
1393873|NCT01320683|Primary|Progression-free Survival|"Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 24 months|||||||
1393874|NCT01320553|Secondary|Ciliary Redness Evaluated by the Investigator|Ciliary redness and episcleral redness were evaluated by the investigator at 7, 15, and 20 minutes post-CAC using a 4-point (0 indicating none and 4 indicating extremely severe i.e. large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) scale with half-unit (1-step) increments allowed.|Up to 4 weeks||||units on a scale||Standard Deviation|Mean
1393875|NCT01320553|Primary|Ocular Itching|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post-challenge (0-4 scale, allowing half unit increments with 0 representing none and 4 representing Incapacitating itch with an irresistible urge to rub) at Visit 5.|Up to 28 days|"Of the 122 subjects enrolled in the study, a total of 8 subjects did not complete the study: 1 in the 1334H 0.15% group, 4 in the 1334H 0.3% group, 2 in the 1334H 0.45% group and 1 in the vehicle treated group.~The Per Protocol population, comprised of all subjects who completed the study with no protocol violations, totaled 107 subjects."|||units on a scale||Standard Deviation|Mean
1393876|NCT01320293|Secondary|Changes in Adiponectin Profile Compared to Baseline|Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.|24 weeks|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.|||pg/ml||95% Confidence Interval|Mean
1393877|NCT01320293|Secondary|Changes in IL-6 Profile Compared to Baseline|IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.|||pg/ml||95% Confidence Interval|Mean
1393878|NCT01320293|Primary|Percentage Change in Endothelial Function Compared to Baseline.|Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).|6 months|17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.|||percent change||95% Confidence Interval|Mean
1393879|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized patients who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
1393880|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Residual Standard Deviation|The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
1393881|NCT01320202|Secondary|Variability of Hemoglobin Concentration: Temporal Trend|The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent to treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured.|||grams per liter per week||Standard Deviation|Mean
1393882|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percentage of saturation||Standard Deviation|Mean
1393883|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||grams per liter||Standard Deviation|Mean
1393884|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Ferritin|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micrograms per liter||Standard Deviation|Mean
1393885|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||picograms||Standard Deviation|Mean
1393886|NCT01320202|Secondary|Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC)|The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.|Up to 48 weeks from the date of randomization|modified Intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
1393887|NCT01320202|Secondary|Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel|A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percentage of change||Standard Deviation|Mean
1393888|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused|The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.|||units of red blood cells or whole blood|||Number
1393889|NCT01320202|Secondary|Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion|The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.|up to 48 weeks from the date of randomization|Intent-to-Treat (ITT): all patients randomized are included.|||participants|||Number
1393890|NCT01320202|Secondary|Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromole per liter||Standard Deviation|Mean
1393891|NCT01320202|Secondary|Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to treat: all randomized subjects who had at least one dose of study drug and had at least one post-dose hemoglobin measured.|||percent||Standard Deviation|Mean
1393892|NCT01320202|Secondary|Mean Change in Serum Iron From Pre-dialysis to Post-dialysis.|The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.|Up to 48 weeks from the date of randomization|modified intent-to-treat population: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured.|||micromoles per liter||Standard Deviation|Mean
1393893|NCT01320202|Primary|Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean|Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean with standard error.|Hgb measured weekly; up to 48 weeks from the date of randomization|modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained.|||grams per liter||Standard Error|Least Squares Mean
1393894|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition|Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
1393895|NCT01320137|Secondary|Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)|Responders are defined as subjects with a concentration after Bet v 1 stimulation above P95 (determined on Bet v 1 BrdU+ subjects) of all concentrations after medium only stimulation|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
1393896|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition|"Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays.~Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation."|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
1393897|NCT01320137|Primary|Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines|"Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays.~Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation"|At Day 0|The According-To-Protocol (ATP) cohort, Bet v 1 BrdU+ subjects included all subjects from the ATP cohort for which proliferation of peripheral blood mononuclear cells (PBMCs) with the birch pollen allergen Bet v 1 was observed after 96 hours.|||Subjects|||Number
1393898|NCT01320072|Secondary|Change in Forced Expiratory Volume in One Second (FEV1) in Aspirin Exacerbated Respiratory Disease (AERD) Patients|We will assess FEV1% change from baseline at 12 months in AERD patients who have been on aspirin treatment for 12 months (current standard of care)|12 months|AERD patients will continue aspirin treatment for 12 months and the change from baseline in their FEV1% predicted will be monitored during this time|||change in percent predicted FEV1||Standard Error|Mean
1393899|NCT01320072|Secondary|Treatment-Related Adverse Events|Adverse reactions defined as bronchospasm requiring endotracheal intubation. The adverse reactions will be assessed through a post challenge follow-up with the patient at baseline and 24 hours after the challenge|24 hours after the challenge||||participants|||Number
1393900|NCT01320072|Primary|Eicosanoid Metabolites Concentration|eicosanoid metabolites concentration in plasma and urine 2 h post ASA challenge|2 hours||||log-pg/mg creatinine||Standard Error|Mean
1393901|NCT01319877|Secondary|Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.|Up to 36 Months|Evaluable participants.|||score on a scale||Standard Deviation|Mean
1393902|NCT01319877|Secondary|One-year Survival Rate by the Chemotherapy Regimen Subgroup||1 year|Participants with known prior chemotherapy regimens were evaluated|||percentage of participants||95% Confidence Interval|Number
1393903|NCT01319877|Secondary|One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.|1 year|Participants with known prior chemotherapy regimens were evaluated.|||percentage of participants||95% Confidence Interval|Number
1393904|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.|Up to 36 Months|Participants with known prior chemotherapy regimens were evaluated|||percentage of participants||95% Confidence Interval|Number
1393905|NCT01319877|Secondary|One-year Survival Rate by the KRAS Subgroup||1 year|Participants with known KRAS status were evaluated|||percentage of participants||95% Confidence Interval|Number
1393906|NCT01319877|Secondary|One-year Progression-free Survival Rate Per KRAS Subgroup|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|1 year|Participants with known KRAS status were evaluated.|||percentage of participants||95% Confidence Interval|Number
1393907|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.|36 months|Participants with known KRAS status were evaluated.|||percentage of participants||95% Confidence Interval|Number
1393908|NCT01319877|Secondary|One-year Survival Rate||1 year||||percentage of participants||95% Confidence Interval|Number
1393909|NCT01319877|Secondary|One-year Progression-free Survival Rate|One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.|1 year||||percentage of participants||95% Confidence Interval|Number
1393910|NCT01319877|Secondary|Progression-free Survival|Progression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.|36 months||||months||95% Confidence Interval|Median
1393911|NCT01319877|Secondary|Percentage of Participants Achieving an Overall Response|Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.|36 months||||percentage of participants||95% Confidence Interval|Number
1393912|NCT01319877|Primary|Percentage of Participants With Bevacizumab-related Serious Adverse Events||36 months||||percentage of participants|||Number
1393913|NCT01319877|Primary|Percentage of Participants With Bevacizumab-Related Adverse Events||36 months||||percentage of participants|||Number
1393914|NCT01319877|Primary|Percentage of Participants With Adverse Events of Special Interest||36 months||||percentage of participants|||Number
1393915|NCT01319877|Primary|Percentage of Participants With Serious Adverse Events|A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.|36 months||||percentage of participants|||Number
1393916|NCT01319877|Primary|Percentage of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|36 months||||percentage of participants|||Number
1393917|NCT01319851|Secondary|Number of Participants Who Experienced Chronic Graft-versus-host Disease (cGVHD), Measured by the NIH Criteria Consensus (NCC)|The severity criteria of chronic graft-versus-host disease (cGVHD) recommended by the NIH Criteria Consensus (NCC) was employed. The number of organs involved and the severity of the disease in these organs dictated the global summary score used to define the disease as mild, moderate, or severe. Mild disease indicates one or two organs involved each with a maximal score of 1. Moderate disease indicates three or more organs involved with a score of 2 in any individual organ, or lung involvement with a score of 1. Severe global GVHD is defined by a score of 3 in any organ, or a lung score of 2.|Day 100 post-transplant||||participants|||Number
1393918|NCT01319851|Secondary|Number of Participants Who Experienced Acute Graft-versus-host Disease (aGVHD), Measured by NIH Consensus Criteria (NCC) Score: Grade II-IV|Cumulative Incidence of Grade II-IV aGVHD Score at 30 Days. The NIH Consensus grading and severity criteria includes physical assessments of skin, oral cavity, eyes, gynecological and laboratory data and patient reports. Each domain is scored from Grade 0 (no involvement) to Grade IV (severe involvement).|Day 30 post-transplant||||participants|||Number
1393919|NCT01319851|Secondary|Incidence of 100% CD33 Donor Chimerism|CD33 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant||||participants|||Number
1393920|NCT01319851|Secondary|Incidence of Greater Than or Equal to 85% CD3 Donor Chimerism|CD3 chimerism was measured from peripheral blood lymphocytes 30 days post transplant. DNA chimerism analysis was performed by amplified fragment length polymorphism.|Day 30 post-transplant||||participants|||Number
1393921|NCT01319851|Secondary|Number of Participants That Expressed Successful Neutrophil Engraftment|Neutrophil engraftment was assessed with absolute neutrophils >500*10^8/kg by 100 days post transplant. Neutrophils were counted by performing a complete blood cell count (CBC).|Day 100 post-transplant||||participants|||Number
1393922|NCT01319851|Secondary|Number of Participants That Expressed Grade 2 or 3 Regimen-Related Toxicity|Regimen-related toxicity was measured using the Bearman criteria. The Bearman criteria grades toxicity levels at Grade 1, Grade 2, Grade 3, and Grade 4. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. All regimen-related toxicities were determined to be unlikely attributable to the study drug.|Day 42 post-transplant||||participants|||Number
1393923|NCT01319851|Primary|Feasibility of Alefacept Pre-conditioning, Measured by Number of Subjects With Full Donor Engraftment|All subjects received alefacept prior to hematopoietic stem cell transplantation and were followed up to at least two years after transplantation to ensure successful engraftment.|Two years post-transplant||||participants|||Number
1393924|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - 30-day Clinical Success|Compare the 30-day clinical success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|30 days|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393925|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Acute Procedure Success|Compare the acute procedure success results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|Acute / Date of Procedure|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393926|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Secondary Patency Rate at 12 Months|Compare the secondary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393927|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Assisted Patency at 12 Months|Compare the primary assisted patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393928|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Stent Fracture Rate at 12 Months|Compare the stent fracture rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393929|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - Primary Patency at 12 Months|Compare the primary patency rate at 12 months between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393930|NCT01319812|Secondary|Comparison of Endpoint Results Between Standard and Long Lesions for the Pulsar Stent - MAE Rate|Compare the MAE rate results between evaluable subjects treated with standard length lesions (between 20 mm and 140 mm) and evaluable subjects treated for long lesions (between 141 mm and 190 mm) for the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393931|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30-Day Clinical Success|Compare the 30-day clinical success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|30 days|Includes all participants who underwent implantation.|||Percentage of participants|||Number
1393932|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Acute Procedure Success|Compare the acute procedure success results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|Acute / Date of Procedure|Includes all participants who underwent implantation.|||Percentage of participants|||Number
1393933|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Secondary Patency Rate at 12-Months|Compare the secondary patency (freedom from bypass and amputation of the target limb) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393934|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Assisted Patency at 12-Months|Compare the primary assisted patency (freedom from remote TVR) at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393935|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - Primary Patency at 12-months|Compare the primary patency at 12-months results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|12 months|Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.|||Percentage of participants|||Number
1393936|NCT01319812|Secondary|Comparison of Endpoints Results Between Occlusive and Non-occlusive Lesions for Astron and Pulsar Stent - 30 Day MAE Rate|Compare the 30 day MAE rate results between evaluable subjects treated for occlusive lesions (100% stenosis) and evaluable subjects treated for non-occlusive lesions (70% - 99% stenosis) for the Astron stent and the Pulsar stent group.|30 days|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants|||Number
1393937|NCT01319812|Secondary|Secondary Safety Assessment for Astron and Pulsar Stent: Adverse Event Rates|Evaluate the rates of all individual adverse event types that are not included in the primary endpoint analyses for the Astron stent and the Pulsar stent group. Please see the Serious Adverse Events and Other Adverse Events sections for event details.|12 month|Includes all participants who underwent implantation.|||Participants with event|||Number
1393938|NCT01319812|Secondary|Clinical Success|Evaluate the 30-day clinical success of the procedure. The 30-day clinical success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs within 30 days of the index procedure.|30 days|The Astron stent group includes all participants who underwent implantation. The Pulsar stent group includes all participants who underwent implantation except for one, due to subject death occurring in the first 30 days.|||Percentage of participants||95% Confidence Interval|Number
1393939|NCT01319812|Secondary|Acute Procedural Success for Astron and Pulsar Stent|Evaluate the acute procedural success of the Astron and Pulsar stent. Acute procedural success is defined as completion of the assigned procedure, the stented lesion having less than 30% residual stenosis determined by angiography immediately after stent placement and no MAEs before hospital discharge.|30 days|Includes all participants who underwent implantation.|||Percentage of participants||95% Confidence Interval|Number
1393948|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate|Evaluate the primary patency of the Astron stent at 12 months post-index procedure as measured by duplex ultrasound. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.|12 months|Includes all participants who underwent successful implantation and had a 12-month evaluable duplex ultrasound assessment.|||Percentage of participants||95% Confidence Interval|Mean
1393940|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Stair Climbing Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Stair Climbing score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ stair climbing scores were available for 142 participants from both baseline and the 12-month visit for the Astron stent group. WIQ stair climbing scores were available for 255 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
1393941|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Speed Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Speed score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ walking speed scores were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking speed scores were available for 263 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
1393942|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire Walking Distance Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire Walking Distance score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100.. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ walking distance scores were available for 144 participants from both baseline and the 12-month visit for the Astron stent group. WIQ walking distance scores were available for 264 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
1393943|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Walking Impairment Questionnaire PAD Specific Score|"The purpose of this endpoint is to compare Walking Impairment Questionnaire (WIQ) Peripheral Arterial Disease (PAD) specific score between baseline and 12 months post-index procedure. The WIQ is a subjective questionnaire completed by participants at baseline and the 12 month visit which asks questions about mobility to assess walking impairment. Larger numbers indicate better outcomes, with a minimum score of 0 and a maximum score of 100. Please see the following publication for further information:~Hiatt WR, Hirsch AT, Regensteiner JG, et al. Clinical Trials for Claudication. Assessment of Exercise Performance, Functional Status, and Clinical Endpoints. Vascular Clinical Trialists. Circulation. 1995;92:614-621"|12 months|Analysis conducted on paired data. WIQ PAD responses were available for 143 participants from both baseline and the 12-month visit for the Astron stent group. WIQ PAD responses were available for 265 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Units on a scale (WIQ score)||Standard Deviation|Mean
1393944|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Six-Minute Walk Test|The purpose of this endpoint is to compare the distance walked during the 6-minute walk test between baseline and 12 months post-index procedure.|12 months|Analysis conducted on paired data. Six-minute walk test results were available for 131 participants from both baseline and the 12-month visit for the Astron stent group. Six-minute walk test results were available for 247 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Feet||Standard Deviation|Mean
1393945|NCT01319812|Secondary|Functional Assessments for Subjects With the Astron and Pulsar Stents - Ankle - Brachial Index (ABI) Measurement|The purpose of this endpoint is to compare the ABI measurements between baseline and 12 months post-index procedure. ABI is the ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm.|12 months|Analysis conducted on paired data. ABI measurements were available for 141 participants from both baseline and the 12-month visit for the Astron stent group. ABI measurements were available for 266 participants from both baseline and the 12-month visit for the Pulsar stent group.|||Ratio (ABI score)||Standard Deviation|Mean
1393946|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Secondary Patency|Evaluate the secondary patency rate (freedom from bypass and amputation of the target limb) for the Astron and Pulsar stent at 12 months post-index procedure.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants||95% Confidence Interval|Number
1393947|NCT01319812|Secondary|Secondary Effectiveness Assessment for the Astron and Pulsar Stents - Primary Assisted Patency|Evaluate the primary assisted patency rate (freedom from remote Target Vessel Revascularization [TVR]) for the Astron and Pulsar stent at 12 months post-index procedure.|12 months|Includes all participants who underwent successful implantation and were included in the 12-month ITT analysis population.|||Percentage of participants||95% Confidence Interval|Mean
1393949|NCT01319812|Secondary|Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate|Evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to the primary endpoint for the Astron stent.|12 months|Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.|||Percentage of participants||95% Confidence Interval|Mean
1393950|NCT01319812|Secondary|Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate|Evaluate the Pulsar stent integrity as measured by x-ray at 12 months post-index procedure. An independent angiographic core laboratory reviewed x-ray imaging for presence or absence of a stent fracture. Fractures were assessed with Grade I indicating a single tine fracture, Grade II indicating multiple tine fracture, Grade III indicating stent fracture(s) with preserved alignment of the components, Grade IV indicating stent fracture(s) with mal-alignment of the components, and Grade V stent fracture(s) in a trans-axial spiral configuration. Generally, fractures of Grade I are least severe, increasing in severity to Grade V.|12 months|Participants with 12 month (395 day) diagnostic X-ray available for fracture evaluation.|||Participants|||Count of Participants
1393951|NCT01319812|Secondary|Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate|Evaluate the long-term major adverse event rate of the Pulsar stent. Likewise, the endpoint will evaluate the contribution of the individual rates of 30-day mortality and 12-month target lesion revascularization and index limb amputation rates to this overall, long-term major adverse event rate.|12 months|Participants who reached at least 395 calendar days post procedure.|||Percentage of participants||95% Confidence Interval|Number
1393952|NCT01319812|Secondary|Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation|Evaluate the contribution of the individual rates of mortality, target lesion revascularization (TLR) and index limb amputation at 30 days post-index procedure to the primary safety endpoint for the Pulsar stent.|30 days|All participants implanted with an Astron Pulsar or Pulsar-18 stent.|||Percentage of participants||95% Confidence Interval|Number
1393953|NCT01319812|Primary|Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)|The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.|12 months|Includes all participants who underwent successful implantation and either met the 30-day mortality categorization or completed a 12-month evaluation.|||Percentage of participants||95% Confidence Interval|Mean
1393954|NCT01319812|Primary|Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events|The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.|30 days|All participants implanted with an Astron Pulsar or Pulsar-18 stent.|||Percentage of participants||95% Confidence Interval|Number
1393955|NCT01319812|Primary|Effectiveness Endpoint for the Pulsar Stent: Primary Patency|The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of > 50% stenosis.|12 months|Participants for whom patency could be confirmed at 12 months.|||Percentage of participants||95% Confidence Interval|Number
1393956|NCT01319799|Secondary|Cerebrospinal Fluid(CSF) Levels of S-100B(Microgram/Liter)|"Differences in preoperative vs postoperative CSF levels of S-100B in microgram/Liter~The assumption is that a cardiac open heart surgical procedure with cardiopulmonary bypass will influence the postoperative level of marker of neuronal cell damage in the central nerve system. An increase in the levels, compared to the preoperative values, indicates neuronal cell damage detectable in the CSF, namely the brains own extracellular fluid."|24 Hours after Surgery||||microgram/Liter||Standard Error|Mean
1393957|NCT01319799|Primary|Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery|Transcranial Doppler measurement of microembolic signals will be measured during the surgical procedure.Microembolic signals are detected by offline analysis of the Dopplerspectral analysis of the blood flow in the medial cerebral artery. Different intensities (dB),flow direction and time frame appearances in the Doppler spectral envelope is distinguishable for a neurosonolgist according to predefined criteria for an embolic signal-defined in previous litterature.The total amount of signals during one surgical procedure is counted. The appearance of microembolic signals related to specific procedures performed during cardiac surgery with cardiopulmonary bypass is noted. The exact time range is not possible to estimate in advance,due to the fact that each surgical procedure varies in time.The range of values for each individual patient, based on pilos, will vary from 50 to approximately 1500 embolic counts for one surgical procedure. A high value is negative for the patient.|(day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance||||units on a scale||Standard Error|Mean
1393958|NCT01319773|Secondary|Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1|Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).|Day 1|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.|||Number of Eyes|Participants||Number
1393959|NCT01319773|Secondary|Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)|Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).|3 Days|Per Protocol: All randomized subjects who received their assigned study medication and closely followed the protocol.|||Number of Subjects|||Number
1393960|NCT01319773|Primary|Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)|Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.|Day 1|Safety Population: All randomized subjects who were treated with at least 1 dose of study medication.|||Nanogram/milliliter (ng/mL)|||Number
1393965|NCT01319721|Primary|Recurrence|Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea.|One Year||||eyes|Participants||Number
1393966|NCT01319617|Primary|Ocular Discomfort|Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.|After 24 hours of device wear||||mm||Standard Deviation|Mean
1393967|NCT01319552|Primary|Measure of Non-transferrin-bound Iron|"Comparison of increase in non-transferrin-bound iron for each participant between his or her fresh and old blood transfusion four hours after transfusion."|four hours after transfusion||||μM||Standard Deviation|Mean
1393968|NCT01319539|Secondary|Change in Ki-67 Expression|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.|||percentage of cells||Standard Deviation|Mean
1393969|NCT01319539|Secondary|Change in pS6 Levels|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.|||percentage of cells||Standard Deviation|Mean
1393970|NCT01319539|Primary|Change in pAKT Levels|This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue).|Baseline, 2 weeks (Day 0 - surgery)|Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue.|||percentage of cells||Standard Deviation|Mean
1393971|NCT01319500|Primary|Reasons for OC Prescriptions by Gynecologists and Dermatologists||February 2009 - March 2009||||number of participants|||Number
1393972|NCT01319500|Primary|Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Non-contraceptive Reasons Only)|"Exclusively non-contraceptive reasons for OC prescriptions (no contraception intended; category non-contraceptive reasons only"|February 2009 - March 2009||||number of participants|||Number
1393973|NCT01319500|Primary|"Non-contraceptive Reasons for OC Prescriptions (Reported by Women Who Used OCs for Contraceptive and Non-contraceptive and Non-contraceptive Only Reasons"|"Non-contraceptive reasons for OC prescriptions (including both categories: contraception plus non-contraceptive reasons and non-contraceptive reasons only"|February 2009 - March 2009||||number of participants|||Number
1393974|NCT01319500|Primary|Reasons for OC Prescriptions|The main reasons for OC prescription: contraception only; contraception combined with non-contraceptive reasons; non-contraceptive reasons only.|February 2009 - March 2009||||percentage of participants||95% Confidence Interval|Number
1393975|NCT01319500|Primary|OC Prescriptions by Treatment Group and Prescribing Medical Specialists|Prescriptions of Yasmin and Other OCs by different physicians (private gynecologists, public gynecologists and dermatologists)|February 2009 - March 2009||||Prescribing physicians|||Number
1393976|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin With Cytokine Profile.|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|The actin polymerization assay that was to be used for this outcome was not reproducible; hence, the cytokine profile of actin polymerized cells could not be pursued. Data were not analyzed.||||||
1393977|NCT01319422|Secondary|To Correlate Drug Induced Changes in F Actin Polymerization With Adverse Effects and Clinical Responses.|Research bone marrow aspirate is obtained to assess response (optional, but recommended), and to document complete remission, if applicable. Correlation to be determined upon completion of study treatment|Research bone marrow aspirate is obtained at baseline and after completion of 2 cycles of therapy (approximately 56 days)|The actin polymerization assay that was to be used for this outcome was not reproducible and data were not analyzed.||||||
1393978|NCT01319422|Secondary|To Compare the Effect of Continuous Versus Intermittent Regimens on F Actin Polymerization in Peripheral Blood Mononuclear Cells and Activation of Tumor Antigen-specific T Cells, as Well as Innate Lymphocytes (Natural Killer or Natural Killer T Cells).|Correlation to be determined upon completion of study treatment|Research blood draw will be obtained at baseline, and at 2-4 hr (on day 1), 1 wk, and 4 wk after initiation of cycles 1 and 2.|N/A: data were not collected on this outcome; initial F actin polymerization assay was unreliable and not reproducible; hence, this outcome could not be pursued.||||||
1393979|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|After the initial efficacy assessment at the completion of cycle 2 (at approximately 56 days), efficacy assessments will be made after every other cycle (approximately every 56 days).||||percentage of participants|||Number
1393980|NCT01319422|Primary|Percentage of Participants With Response, Analyzed Per International Myeloma Working Group Response Criteria|All partial and complete responses must be confirmed with another efficacy assessment in no less than 4 weeks apart.|Efficacy assessments will be made after the first two cycles of therapy (approximately 56 days--each cycle is 28 days)||||percentage of participants|||Number
1393981|NCT01319396|Primary|Accuracy of Breathing Rate Measurement|accuracy of breathing rate indicated by the BiancaMed BM07 device, compared to that indicated by Somnoscreen to be +/- 5 breaths per minute (95% confidence)|2 minutes|Each participant gives 8 test points, thus with 22+ participants, there are >160 test points, which is sufficient to give a standard deviation.|||breaths per minute||Standard Deviation|Mean
1393982|NCT01319383|Other Pre-specified|Number of Participants Developing Cancer Within 5 Years Following >/= 8 Vorinostat Dose Exposures|Development of a new cancer within the 5 years of taking their last dose of VOR 400 mg PO.All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study. Pre-specified to be reported as one group.|From last dose Vorinostat to 5 years afterwards|At end of study, participants receiving >/= 8 doses of Vorinostat are enrolled in a 5-year cancer incidence database to be monitored for the occurrence of cancer.|||Participants|||Count of Participants
1393983|NCT01319383|Secondary|Number of Participants With Confirmed Hematologic Toxicity >/= Grade 2 and Related to VOR Per Division of AIDS (DAIDS) Grading Table|DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.|24 hrs following single dose and 1 week after last of multiple dose sequence|All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.|||Participants|||Count of Participants
1393984|NCT01319383|Secondary|Number of Participants With Confirmed Non-hematologic Toxicity >/= Grade 3 and Related to VOR Per Division of AIDS (DAIDS) Grading Table|DAIDS Grading Table- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening. Pre specified to combine all participants into one arm.|24 hrs following single dose and 1 week after last of multiple dose sequence|All participants receiving one or more doses of VOR 400 mg PO in any and all Arms of the study.|||Participants|||Count of Participants
1393985|NCT01319383|Secondary|Number of Participants With Measurable Changes in Plasma HIV-1 RNA|Assess for detectible HIV-1 RNA > 150 copies/mL, confirmed by repeat evaluation, following VOR dose. By standard assay and single copy assay. Pre specified to combine all participants into one arm.|1 week after last VOR dose|All participants receiving one or more doses of VOR in any and all Arms of the study.|||Participants|||Count of Participants
1393986|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Multiple (n = 10) Interval Doses|Participants in Arm 2, Step 4 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after administration of 10 doses of VOR 400 mg PO, given 72 hours apart.|Baseline, Visit 9|Participants who demonstrated a significant in vivo response after taking 2 doses of VOR 400 mg PO, each dose taken 72 hours apart were administered 10 doses of VOR based on the optimal dosing of 72 hours.|||Participants|||Count of Participants
1393987|NCT01319383|Primary|Number of Participants With a Significant in Vivo Response in Resting Cell Infection (RCI) and HIV RNA After Paired Doses|Induction of significant in vivo RCI and RCLV response after 2 doses of VOR 400 mg PO administered 48 hours apart or 72 hours apart|Baseline, Visit 6|Participants showing an in vivo response in resting CD4+ T cell- associated HIV RNA (RCVL) after a single dose of VOR were administered 2 doses of VOR 400 mg separated by either 48 or 72 hours to determine the optimal interval/spacing to observe a significant in vivo response in the RCVL after the paired doses.|||Participants|||Count of Participants
1393988|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T-cell-associated HIV RNA (Rc-RNA) Increase Following Each of Two Multiple Dose Cycles (11 Doses/Cycle)|Participants in Arm 1, Step 3 were analyzed for an in vivo increase in the resting CD4+ T cell- associated HIV RNA (RCVL) after 11 doses of VOR 400 mg PO. This cycle was repeated after a 5 - 8 week rest period for a 2nd series and measurement.|Baseline, Visit 18, Visit 29|Participants with resting CD4+ T-cell-associated HIV RNA (rc-RNA) increases after receiving daily VOR Monday through Wednesday for 8 weekly cycles were enrolled.|||Participants|||Count of Participants
1393989|NCT01319383|Primary|Number of Participants Exhibiting an in Vivo Resting CD4+ T Cell- Associated HIV RNA (RCVL) Increase After Receiving a Single Dose of VOR 400 mg PO|Participants in Arm 1 and 2 were analyzed in Step 2 for an in vivo increase in resting CD4+ T cell- associated HIV RNA (RCVL) after administration of a single dose of VOR 400 mg PO|Arm1: Baseline, Visit 5 and Arm 2: Baseline and Visit 3||||Participants|||Count of Participants
1393990|NCT01319318|Primary|Percentage of Participants With Vitreous Cell Count of 0|The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (>50 cells) worst.|Week 4|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
1393991|NCT01319110|Secondary|Comparison of Serum CoQ10 Levels Randomized to Supplementation vs. Placebo|The secondary outcome will be to compare serum CoQ10 levels among those post-arrest patients randomized to CoQ10 supplementation vs placebo.|1 year|This data was not collected when the study was performed||||||
1393992|NCT01319110|Primary|Prevalence of Low Serum CoQ10 Levels in Cardiac Arrest Patients|The primary outcome will be describing the prevalence of low serum CoQ10 levels compared to standard laboratory control values.|Baseline||||ug/mL||Standard Deviation|Mean
1393993|NCT01319045|Secondary|Quality of Life|Change in quality of life as assessed by SF-36 QOL|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained||||||
1393994|NCT01319045|Secondary|Serum Brain Natriuretic Peptide (BNP)|Change in serum BNP level|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained||||||
1393995|NCT01319045|Secondary|Exercise Capacity|Change in exercise duration (modified Bruce protocol), maximal oxygen consumption (VO2 max), and/or VE/VCO2 ratio.|3 months|unable to analyze because study was terminated prematurely and therefore follow up assessments were not obtained||||||
1393996|NCT01319045|Primary|Safety and Tolerability|Number of Participants with adverse events, specifically mortality and heart failure.|3 months|Number of adverse events.|||participants|||Number
1393997|NCT01318993|Secondary|Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks|IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale.|Baseline (Week 0) and up to 112 weeks|ITT population was planned to be analyzed for this study. However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.||||||
1393998|NCT01318993|Secondary|Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed.|Baseline (Week 0) and up to 112 weeks|ITT population was planned to be analyzed for this study.However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure.||||||
1393999|NCT01318993|Secondary|Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented.|Baseline (Week 0) and up to 108 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants||95% Confidence Interval|Number
1394000|NCT01318993|Secondary|Change From Baseline (Week 0) in Crohn’s Disease Activity Index (CDAI) Score Over 108 Weeks|The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline (Week 0) and up to 108 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Scores on a scale||Standard Deviation|Mean
1394001|NCT01318993|Secondary|Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value|QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia’s formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett’s formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)|Safety Population. Only participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1394002|NCT01318993|Secondary|Change From Baseline (Week 0) in Albumin|Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||Grams/Liter (G/L)||Standard Deviation|Mean
1394003|NCT01318993|Secondary|Change From Baseline (Week 0) in Total Bilirubin|Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||micromole/Liter||Standard Deviation|Mean
1394004|NCT01318993|Secondary|Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)|Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||International Unit per Liter (IU/L)||Standard Deviation|Mean
1394018|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks|"Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).~Participants with multiple abnormalities were counted only once in the worst category."|within 48 weeks|Participants in the Safety Set with available data|||percentage of participants|||Number
1394019|NCT01318694|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks|"ALT abnormalities were summarized as participants who had either:~ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline~ALT > 3 x ULN during the study and > 2 x ULN at baseline"|within 48 weeks|Participants in the Safety Set, defined as having received at least one dose of study medication, with available data|||percentage of participants|||Number
1394005|NCT01318993|Secondary|Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters|Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1394006|NCT01318993|Secondary|Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters|Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.|Baseline (Week 0) and up to Week 112|Safety Population. Only the participants available at the time of analysis were included.|||Participants|||Count of Participants
1394007|NCT01318993|Secondary|Change From Baseline (Week 0) in Heart Rate (HR) Over Period|The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1394008|NCT01318993|Secondary|Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period|The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Week 0) and up to Week 112|Safety Population. Only participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1394009|NCT01318993|Primary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product.|Up to Week 112|Safety Population|||Participants|||Count of Participants
1394010|NCT01318967|Secondary|Measurement of Regional Blood Oxygenation by MRI|Estimate of renal blood flow by using MRI scans before and after the administration of furosemide|One measure after furosemide (day 1)||||ml/min||Full Range|Mean
1394011|NCT01318967|Primary|Measurement of Renal Blood Flow of the Kidney by the PAH Method|Renal blood flow is estimated by the PAH method.|Renal blood flow is estimated over 1 hour by PAH||||ml/min||Full Range|Mean
1394012|NCT01318915|Primary|Percentage of Participants Successfully Withdrawn From Immunosuppression and Remain Off Immunosuppression for at Least 52 Weeks.|Participants are considered as successfully withdrawn from immunosuppression if they remain off immunosuppression for at least 52 weeks without evidence of rejection, as determined by a biopsy performed 52 weeks after completion of immunosuppression withdrawal. All participants who fail to complete immunosuppression withdrawal, regardless of reason, or fail to have a biopsy 52 weeks after completion of immunosuppression withdrawal will be considered to have failed. The endpoint will be summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 weeks after stopping all immunosuppression.|Transplanted Participants|||percentage of participants||95% Confidence Interval|Number
1394013|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8 and 29||||participants|||Number
1394014|NCT01318876|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation||at day 8 and 29||||participants|||Number
1394015|NCT01318733|Primary|Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.|"Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema~/ Almost clear; slight redness~/ Mild erythema; definite redness~/ Moderate erythema; marked redness~/ Severe erythema; fiery redness~Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1."|Over 1 year||||scores on a scale||Standard Deviation|Mean
1394016|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data|||percentage of participants|||Number
1394017|NCT01318694|Secondary|Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks|Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.|within 48 weeks|Participants in the Safety Set with available data|||percentage of participants|||Number
1394024|NCT01318694|Secondary|Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment|EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.|after 12 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
1394025|NCT01318694|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)|RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.|after 4 weeks of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
1394026|NCT01318694|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks after the end of treatment|Participants in the Full Analysis Set with available data|||percentage of participants|||Number
1394027|NCT01318694|Primary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
1394028|NCT01318538|Secondary|Change in Mean Drinks Per Drinking Day for Women|This represents the change from baseline in the mean number of drinks per drinking day. Drinks per drinking day was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drinks per drinking day. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||change in mean drinks per drinking day||95% Confidence Interval|Mean
1394029|NCT01318538|Secondary|Percent Change in Mean Heavy Drinking Days for Women|This represents the percent change from baseline in the mean number of heavy drinking days for women. Number of heavy drinking days was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean heavy drinking days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||% change in mean heavy drinking days||95% Confidence Interval|Mean
1394030|NCT01318538|Secondary|Percent Change in Mean Drug Use Days for Women|This represents the percent change from baseline in the mean number of drug use days (excluding alcohol) for women. Days of drug use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drug use days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||% change in mean drug use days||95% Confidence Interval|Mean
1394031|NCT01318538|Other Pre-specified|Group Stability|Treatment group stability was calculated using the Percentage of Group Change Index which captures change in group membership composition from session to session separately for each individual within each group (specific to the calendar period that each person was in the group). The value can range from 0 (i.e., the exact same membership from one session to the next) to 1 (i.e., complete turnover in membership). The average values across all sessions were taken to get an overall sense of the amount of turnover each person experienced in the group during the period in calendar time they were in treatment.|In treatment (weeks 1-12)|Only women were included in this analysis.|||units on a scale||Standard Deviation|Mean
1394032|NCT01318538|Other Pre-specified|Group Attendance|Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12.|In treatment (weeks 1-12)|Only women were included in this analysis.|||sessions attended||Standard Deviation|Mean
1394033|NCT01318538|Other Pre-specified|Therapist Adherence|All therapists were female to eliminate any therapist-patient gender matching effects. There were eight therapists in total: 4 who led WRG groups and 4 who led GDC groups. All group sessions were videotaped each week so that we could measure therapist adherence to the treatment they were assigned to. Two independent raters completed adherence scales for a random selection of 20% of WRG and 10%of GDC sessions. For both groups, the extensiveness to which the therapist engaged in a behavior during the session was rated with a 5-point Likert scale (0 = not at all; 4 = extensively). Adherence scores were calculated by averaging all scores for each question (25 questions for WRG; 18 for GDC) on the measure. The scores reported here represent the average of all WRG therapists scores from all session, and all GDC therapist scores from all sessions. Scores range from 0 to 4.|In treatment (weeks 1-12)||||units on a 0-4 adherence scale|Sessions|Standard Deviation|Mean
1394034|NCT01318538|Primary|Change in Mean ASI Drug Composite Score for Women|"This represents the change from baseline in mean ASI Drug composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.~The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems."|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||change in ASI Drug composite score||95% Confidence Interval|Mean
1394035|NCT01318538|Primary|Change in Mean ASI Alcohol Composite Score for Women|"This represents the change from baseline in mean ASI Alcohol composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.~The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems."|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||change in ASI Alcohol composite score||95% Confidence Interval|Mean
1394036|NCT01318538|Secondary|Percent Change in Mean Alcohol Use Days for Women|This represents the percent change from baseline in the mean number of alcohol use days. Days of alcohol use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline alcohol use data. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Some participants did not complete this measure at the specified time points. Only women were included in this analysis.|||percent change in Alcohol Use Days||95% Confidence Interval|Mean
1394037|NCT01318538|Primary|Percent Change in Mean Days of Any Substance Use for Women|This represents the percent change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol) for women. Days of substance use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean days of any substance use. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.|In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)|Only women were included in this analysis.|||% change in mean substance use days||95% Confidence Interval|Mean
1394038|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 6|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 10 (Maintenance Period Month 6)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
1394039|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 5|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 9 (Maintenance Period Month 5)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
1394040|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 8 (Maintenance Period Month 4)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
1394041|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 7 (Maintenance Period Month 3)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
1394042|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 6 (Maintenance Period Month 2)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
1394043|NCT01318512|Primary|Average Dose of MIRCERA During Maintenance Period Month 1|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.|Month 5 (Maintenance Period Month 1)|All participants who received at least one dose of MIRCERA during the maintenance period.|||microgram (µg)||Standard Deviation|Mean
1394044|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 4|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 4|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
1394045|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 3|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 3|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
1394046|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 2|The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.|Month 2|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
1394047|NCT01318512|Primary|Average Dose of MIRCERA During Titration Period Month 1|The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.|Month 1|All participants who received at least one dose of MIRCERA during titration period.|||microgram (µg)||Standard Deviation|Mean
1394048|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Maintenance Period|The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA|Month 5, 6, 7, 8, 9, 10|All participants who received at least one dose of MIRCERA during maintenance period.|||g/L||Standard Deviation|Mean
1394049|NCT01318512|Secondary|The Mean Hemoglobin (Hb) Level During Titration Period|The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.|Baseline, Month 1, 2, 3, 4|All participants who received at least one dose of MIRCERA during titration period.|||g/L||Standard Deviation|Mean
1394050|NCT01318512|Primary|Average Dose of MIRCERA at Entry Level|The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.|Baseline|All participants who received at least one dose of MIRCERA during the titration period.|||microgram (µg)||Standard Deviation|Mean
1394051|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Pain Free by Visit|Ocular pain was assessed by the patient on a 6-unit scale from 0 (none; absence of positive sensation), to 5 (severe; intense ocular, periocular or radiating pain requiring prescription analgesic). Pain free was defined as an ocular pain assessment score of 0. To be included in the cumulative summary at a visit, a patient must have been declared pain free at the visit and remained pain free at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
1394052|NCT01318499|Other Pre-specified|Cumulative Percentage of Patients Cured by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. To be included in the cumulative summary at a visit, a patient must have been declared cured at the visit and remained cured at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
1394053|NCT01318499|Post-Hoc|Cumulative Percent Clinical Success by Visit|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Clinical success occurred when the cell grade was ≤ 1 (0-5 cells) and flare grade was = 0. To be included in the cumulative summary at a visit, a patient must have been declared a clinical success at the visit and remained a clinical success at all subsequent visits.|Day 1, Day 3, Day 7, Day 14|All randomized patients with at least one post-operative assessment (intent-to-treat).|||Percentage of patients|||Number
1394054|NCT01318499|Secondary|Percentage of Patients Cured at Day 7, Nepafenac 0.3% vs. Nepafenac 0.1%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 7 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
1394055|NCT01318499|Primary|Percentage of Patients Cured at Day 14, Nepafenac 0.3% vs. Nepafenac Vehicle 0.3%|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare.|Day 14 postoperative|All randomized patients with at least one postoperative assessment (intent-to-treat), last observation carried forward.|||Percentage of patients|||Number
1394056|NCT01318408|Primary|ADAS-cog at Baseline and at 3 Months.|"ADAScog (Alzheimer's Disease Assessment Scale-cognitive subscale) consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Score ranges from 0 - 70.~Lower scores (negative change) indicate improvements on the Alzheimer’s Disease Assessment Scale–Cognitive (ADAS-cog)."|Baseline and Three (3) months||||units on a scale||Standard Deviation|Mean
1394057|NCT01318408|Secondary|Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated.||three months|||||||
1394058|NCT01318408|Primary|MMSE at Baseline and at Three (3) Months.|The MMSE (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of Food and Drug Administration (FDA) products approved for the treatment of AD. The MMSE consists of five components; 1) orientation to time and place, 2) registration of three words, 3) attention and calculation, 4) recall of three words, and 5) language. The scores from each of the five components are summed to obtain the overall MMSE score. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Baseline and Three months||||units on a scale||Standard Deviation|Mean
1394059|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.|||percentage of participants||95% Confidence Interval|Number
1394077|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394060|NCT01318382|Secondary|Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB.|Up to 1 minute prior to tracheal extubation|The Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.|||percentage of participants||95% Confidence Interval|Number
1394061|NCT01318382|Secondary|Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)|Neuromuscular functioning was monitored at time of PACU arrival by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 2 minutes prior to PACU arrival|The PACU Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of PACU arrival.|||percentage of participants||95% Confidence Interval|Number
1394062|NCT01318382|Primary|Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation|Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|Up to 1 minute prior to tracheal extubation|Per-Protocol Population was defined as all enrolled participants for whom TOF-Watch SX® measurements were collected and had an evaluable TOF Ratio at time of tracheal extubation.|||percentage of participants||95% Confidence Interval|Number
1394063|NCT01318278|Secondary|All Cause Mortality||admission to hospital discharge, up to 15 months||||participants|||Number
1394064|NCT01318278|Secondary|Neurodevelopmental Outcomes||hospital discharge to follow up at 18-24 months of age|||||||
1394065|NCT01318278|Secondary|Presence of Bronchopulmonary Dysplasia (BPD)|Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD|36 weeks postmenstrual age||||participants|||Number
1394066|NCT01318278|Secondary|Retinopathy of Prematurity Stage 3 or Higher|"All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis.~Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages."|Until hospital discharge, up to 15 months||||participants|||Number
1394067|NCT01318278|Secondary|Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound||Until hospital discharge, up to 15 months||||participants|||Number
1394068|NCT01318278|Secondary|Presence of Patent Ductus Arteriosus (PDA)||until hospital discharge, up to 12 weeks||||participants|||Number
1394069|NCT01318278|Secondary|Ventilator Days||Until hospital discharge, up to 15 months||||days||Inter-Quartile Range|Median
1394070|NCT01318278|Secondary|Necrotizing Enterocolitis||until hospital discharge, up to 12 weeks||||participants|||Number
1394071|NCT01318278|Secondary|Evidence of Ischemic Changes|Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.|96 hours or until medication completely stopped||||participants|||Number
1394072|NCT01318278|Secondary|Urine Output||96 hours or until hypotension resolved and medication completely stopped||||ml/kg/hr||Standard Deviation|Mean
1394073|NCT01318278|Secondary|Hyponatremia||96 hours or until medication completely stopped||||participants|||Number
1394074|NCT01318278|Secondary|Acid-base Status||96 hours or until hypotension resolved and medication completely stopped|Treatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gases|||pH||Standard Deviation|Mean
1394075|NCT01318278|Secondary|Heart Rate Change From Baseline|Heart rate change from baseline during study drug administration|96 hours or until hypotension completely resolved and medications stopped|This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.|||beats per minute||Standard Deviation|Mean
1394076|NCT01318278|Primary|Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life|Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP|24 hours of life|This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.|||participants|||Number
1394099|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394078|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394079|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394080|NCT01318135|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394081|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394082|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394083|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394084|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394085|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394086|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 36).|The change between the value of fasting blood glucose collected at week 36 and baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394087|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 32).|The change between the value of fasting blood glucose collected at week 32 and baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394088|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 28).|The change between the value of fasting blood glucose collected at week 28 and baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394089|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 24).|The change between the value of fasting blood glucose collected at week 24 and baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394090|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 20).|The change between the value of fasting blood glucose collected at week 20 and baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394091|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 16).|The change between the value of fasting blood glucose collected at week 6 and baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394092|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 12).|The change between the value of fasting blood glucose collected at week 12 and baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394093|NCT01318135|Secondary|Change From Baseline in Fasting Blood Glucose (Week 8).|The change between the value of fasting blood glucose collected at week 8 and baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394094|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to 52).|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394095|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394096|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394097|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394098|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394100|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394101|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394102|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394103|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394104|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394105|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394106|NCT01318135|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394107|NCT01318135|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis.|||participants|||Number
1394108|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394109|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).|The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394110|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).|The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 24.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394111|NCT01318122|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394112|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Final Visit).|The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394113|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394114|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394115|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394125|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394126|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394127|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394128|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394129|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394130|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394131|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394132|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394133|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394134|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394135|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394136|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394137|NCT01318122|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394138|NCT01318122|Primary|Number of Participants With Adverse Events.|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|52 Weeks.|Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period.|||participants|||Number
1394139|NCT01318109|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394140|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394141|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394142|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394143|NCT01318109|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394144|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394145|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394146|NCT01318109|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394147|NCT01318109|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394148|NCT01318083|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394149|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394150|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394151|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394152|NCT01318083|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394194|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Post-chemotherapy and CYP17i-naïve Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable Post-chemotherapy and CYP17i-naïve patients with bone metastasis at baseline|||participants|||Number
1394153|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394154|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394155|NCT01318083|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394156|NCT01318083|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394157|NCT01318070|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394158|NCT01318070|Secondary|Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).|The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394159|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394160|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394161|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394162|NCT01318070|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1394163|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394164|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1395583|NCT01305200|Secondary|Incidence of Total Parenteral Nutrition (TPN) Administration.|Total Parenteral Nutrition = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||percentage of participants|||Number
1394165|NCT01318070|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1394166|NCT01317901|Primary|Response|Response was assessed by the investigator on the basis of clinical, radiological, and pathological (i.e., bone marrow) criteria, using the IWG criteria (Cheson et al 2007). A CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Day 15 and Day 28 of even-numbered cycles|All treated subjects|||participants|||Number
1394167|NCT01317797|Secondary|Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)|Ritchie articular index (RAI); a joint count that grades the tenderness of 26 joints on a scale of 0-3); the number of swollen joints from 44 joints (swollen44); ESR in mm/hour after 1 hour and the patient’s global disease activity on a Visual Analogue Scale (VAS) of 100 mm (0=no disease activity to right end of the line 100=maximum disease activity) were used to calculate DAS44-ESR using the following formula: DAS44-ESR = 0.54*sqrt(RAI) + 0.065*(swollen44) + 0.33*ln(ESR) + 0.0072*VAS. Lower numbers were better. A negative change from Baseline indicated improvement.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.|||score on a scale||Standard Deviation|Mean
1394168|NCT01317797|Secondary|Percentage of Participants With American College of Rheumatology (ACR 20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118|All randomized participants with data available for analysis.|||percentage of participants|||Number
1394169|NCT01317797|Secondary|Number of Participants With Anti-MT203 Antibodies|Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
1394170|NCT01317797|Secondary|Change From Baseline in MT203/GM-CSF Complexes in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118|All randomized participants with data available for analysis.|||pg/mL||Standard Deviation|Mean
1394171|NCT01317797|Secondary|Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma|MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.|Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118|All randomized participants with data available for analysis.|||pg/mL||Standard Deviation|Mean
1394172|NCT01317797|Secondary|Ctrough: Maximum Observed Plasma Concentration Pre-Dose||Days 1, 15 and 29 Pre-dose|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||μg/mL||Full Range|Geometric Mean
1394173|NCT01317797|Secondary|Terminal Phase Elimination Half-life (T1/2) for MT203|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated.|||days||Full Range|Mean
1394174|NCT01317797|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||day*μg/mL||Full Range|Geometric Mean
1394175|NCT01317797|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|Day 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||day*μg/mL||Full Range|Geometric Mean
1394176|NCT01317797|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||day*μg/mL||Full Range|Geometric Mean
1394195|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable chemotherapy-naïve and CYP17i-naïve patients with bone metastasis at baseline|||participants|||Number
1394177|NCT01317797|Secondary|Cmax: Maximum Observed Plasma Concentration for MT203|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)|PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.|||μg/mL||Full Range|Geometric Mean
1394178|NCT01317797|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax|Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)||||days||Full Range|Median
1394179|NCT01317797|Primary|Number of Participants Reporting One or More Treatment Emergent Adverse Events|An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
1394180|NCT01317797|Primary|Number of Participants With Clinically Significant Physical Examination Findings|The physical examination included body system assessments: eyes, head and neck (including thyroid), ears, nose and throat, lymph nodes, cardiovascular, lungs, mammae, abdomen (liver, spleen), genitals, limbs, central and peripheral nervous system, musculoskeletal system, skin & nails, mucosae. The Investigator classified abnormal findings as either clinically significant or not clinically significant.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
1394181|NCT01317797|Primary|Number of Participants With Clinically Significant Pulmonary Function Tests|Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
1394182|NCT01317797|Primary|Number of Participants With Clinically Significant Vital Signs|Vital signs included Systolic Blood Pressure (BP), Diastolic BP, body temperature, heart rate. Alert values were: BP systolic > 170 mmHg or < 85 mmHg, BP diastolic > 105 mmHg, Difference BP systolic vs. Baseline (pre-treatment) > 40 mmHg or Pulse rate < 35 bpm or > 120 beats per minute (bpm).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
1394183|NCT01317797|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Alert values for ECG were: Heart rate < 35 bpm or > 120 bpm, QTc acc. to Bazett (absolute value)> 500 ms or QTc acc. to Bazett (increase versus Baseline (pre-treatment).|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
1394184|NCT01317797|Primary|Number of Participants With Clinically Significant Clinical Laboratory Results|Blood was collected for Haematology, Chemistry and Coagulation. Urine was collected for Urinalysis. Alert values for laboratory results include the following: Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl-transpeptidase (GGT), alkaline phosphatase (AP), total bilirubin (TBil): > 3 times upper limit of normal (ULN). Creatinine and Glucose: > 2 times ULN. Potassium > 6.0 or < 3.0 mmol/L. Haemoglobin: Male < 8.0 ;Female < 7.0 g/dL. Erythrocytes :Male < 3.5 x 10^12/L or > 7 x 10^12/L;Female < 3.0 x 10^12/L or > 6.5 x 10^12/L. White Blood Cells (WBC): < 2.8 x10^9/L or > 16.0 x 10^9/L. Eosinophils > 20 % of cells in the WBC differential. Platelet Count < 75 x 10^9/L or 600 x 10^9/L. No alert values were identified for Coagulation or Urinalysis.|From Day 1 Up to Day 118|Safety population included all randomized participants who received study drug.|||participants|||Number
1394185|NCT01317667|Secondary|Over Response Rates and Comparisons for ELISA and TNA Titers|Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion.|Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12|Per-protocol population. Only observations or specimens collected according to the protocol were included in the immunogenicity analyses.|||participants|||Number
1394186|NCT01317667|Primary|Number of Vaccinated Subjects Any Averse Events and by Location and Severity||Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months|Safety population: any subject receiving a vaccination|||participants|||Number
1394187|NCT01317641|Secondary|Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of Major Metabolite ORM-15341 at Day 1||1 day|PK population (Day 1)|||h||Standard Deviation|Median
1394188|NCT01317641|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Major Metabolite ORM-15341 at Steady-state||Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||ng/mL||Standard Deviation|Mean
1394189|NCT01317641|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of Major Metabolite ORM-15341 at Steady-state|AUC(0-8h)|Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||h*ng/mL||Standard Deviation|Mean
1394190|NCT01317641|Secondary|Phase 1: Time to Reach the Maximum Observed Concentration (Tmax) of ODM-201 at Day 1||1 day|PK population (Day 1)|||h||Standard Deviation|Median
1394191|NCT01317641|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of ODM-201 at Steady-state||Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||ng/mL||Standard Deviation|Mean
1394192|NCT01317641|Secondary|Phase 1: Area Under the Plasma-Concentration-time Curve (AUCt) of ODM-201 at Steady-state|AUC(0-8h)|Day 8 predose 0 h and 0.5, 1, 1.5, 2, 4, 6 and 8 h postdose|PK population (Day 8)|||h*ng/mL||Standard Deviation|Mean
1394193|NCT01317641|Secondary|Phase 1 and 2: Participants With Stable Bone Disease in Post-CYP17i Group|Number of participants with stable bone disease (no change). Radiographic bone progression was defined by the appearance of two or more new lesions on bone scan|3 months|Evaluable post-CYP17i patients with bone metastasis at baseline|||participants|||Number
1398811|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1394196|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Responses in Soft Tissue in Post-CYP17i Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Post-CYP17i patients|||participants|||Number
1394197|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Post-chemotherapy and CYP17i-naive Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Post-chemotherapy and CYP17i-naïve patients|||participants|||Number
1394198|NCT01317641|Secondary|Phase 1 and 2: Participants With RECIST Response in Soft Tissue in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with overall complete response (CR), partial response (PR) or stable (SD) soft tissue disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in chest, abdomen, and pelvic CT or MRI scans.|3 months|Evaluable Chemotherapy-naïve and CYP17i-naïve patients|||participants|||Number
1394199|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-CYP17i Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with CYP17 inhibitor|3 months|Evaluable post-CYP17 inhibitor patients|||participants|||Number
1394200|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Post-chemotherapy and CYP17i-naïve Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants previously treated with chemotherapy but not CYP17 inhibitor|3 months|Evaluable post-chemotherapy and CYP17i-naïve patients|||participants|||Number
1394201|NCT01317641|Secondary|Phase 1 and 2: Participants With Decline of at Least 50% in Prostate-specific Antigen (PSA) in Chemotherapy-naïve and CYP17i-naïve Group|Number of participants with greater than or equal to 50% decrease in serum PSA from baseline at 12 weeks in group of participants who were naïve to both chemotherapy and CYP17 inhibitor|3 months|Evaluable chemotherapy-naïve and CYP17i-naïve patients|||participants|||Number
1394202|NCT01317641|Primary|Phase 1: Number of Dose Limiting Toxicities Used to Determine the Maximum Tolerated Dose|The MTD is defined as dose level at which 2 or more out of 6 participants experience a dose limiting toxicity (DLT)|Up to 28 days for each cohort|Safety population included all participants in Phase 1 who received any study drug.|||DLTs|||Number
1394203|NCT01317641|Primary|Phase 1: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)|A DLT was any Grade 3 or more toxicity (by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE version 4.03]) excluding less than Grade 4 neutropenia or thrombocytopenia, hematological toxicity lasting less than 7 days, and nausea, vomiting, diarrhea controlled with antiemetic and/or anti-diarrheal treatment.|Up to 28 days for each cohort|Safety population included all participants in Phase 1 who received any study drug.|||events|||Number
1394204|NCT01317615|Secondary|Overall Survival (OS)|OS was defined as the time from date of start of treatment to date of death due to any cause.|12 months|All participants were included in the analysis.|||Days||95% Confidence Interval|Median
1394205|NCT01317615|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.|6 months|All participants were included in the analysis.|||Days||95% Confidence Interval|Median
1394206|NCT01317615|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.|||Percentage of participants|||Number
1394207|NCT01317615|Secondary|Percentage of Participants With Overall Response Rate (ORR)|ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.|3 months|All participants were included in the analysis.|||Percentage of participants|||Number
1394208|NCT01317615|Secondary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|All participants were included in the analysis.|||Percentage of participants|||Number
1394310|NCT01316419|Secondary|Mean Blood Lipid Change - Low Density Lipoprotein (LDL)-Cholesterol|Mean blood lipid change from baseline - low density lipoprotein (LDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
1394209|NCT01317615|Primary|Percentage of Participants Progression-free|Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.|3 months|All participants were included in the analysis.|||Percentage of participants|||Number
1394210|NCT01317199|Secondary|(Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline|Change in PSA values drawn over study period, taken every 3 months. PSA is measured in ng/mL|At month 12 post-intervention|Patients counted in the analysis were evaluable if they completed at least six cycles of treatment prior to discontinuation|||Participants|||Count of Participants
1394211|NCT01317199|Secondary|(Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%||At month 12 post-intervention|Data was not collected for this secondary outcome measure.||||||
1394212|NCT01317199|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events reported verbally by patient and documented in study notes.|At month 12 post-intervention||||Participants|||Count of Participants
1394213|NCT01317199|Primary|(Phase II) Prostate Specific Antigen Doubling Time (PSADT)|To define the effects of placebo and two different daily doses of MPX on PSADT in men who have rising PSA after initial definitive therapy for localized prostate cancer.|Change from baseline to month 12||||months||Full Range|Median
1394214|NCT01317199|Primary|(Phase I) Maximum Tolerated Dose|To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.|Up to 7 months post-intervention||||mg|||Number
1394215|NCT01317160|Secondary|Time From Injury to Surgery|"Prognostic factor:~Time to surgery , i.e. the time from ATR injury to start of the surgical procedure, will be calculated by using the time-point at which the patient sustained the injury as described in the patient journal, as well as the starting time point of the surgery as registered in the computerized operation report."|1 year||2018-07-31|07/2018||||
1394216|NCT01317160|Secondary|Microdialysis|At 2 weeks postoperatively in-vivo microdialysis will be performed on as described by Greve et al 2012 (DOI: 10.1111/j.1600-0838.2012.01475.x). In the microdialysate different substances will be assessed, eg. markers of tendon callus production, procollagen type I (PINP) and type III (PIIINP) N-Terminal propeptide by enzymatic quantification.|2 weeks|||||||
1394217|NCT01317160|Secondary|Patient-reported Outcome and Physical Activity|The patients’ symptoms and physical activity levels were assessed using four reliable and valid scores; the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group’s questionnaire (EQ-5D).|One year|||||||
1394218|NCT01317160|Secondary|Venous Thromboembolic Events (VTE)|"At 6 weeks postoperatively the number of participants with VTE events will be assessed by:~1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|6 weeks||||participants|||Number
1394219|NCT01317160|Secondary|Functional Outcome - Muscular Endurance Tests (Heel-rise)|The functional outcome will be assessed at 52 weeks post-operatively by validated muscular endurance test, i.e. heel rise test.|one year|||||||
1394220|NCT01317160|Primary|Venous Thromboembolic Events (VTE)|"At 2 weeks postoperatively the number of participants with VTE events will be assessed by:~1) DVT detected by compression duplex ultrasound (CDU) , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography."|2 weeks|Non-compliance was defined by exposure to less than ten hours of IPC. Therefore, two patients were withdrawn on this basis and the treatment group comprised 67 patients at final analysis.|||participants|||Number
1394221|NCT01317095|Secondary|Postop Length of Hospital Stay.|Postoperative length of hospital stay.|Until hospital discharge|Postoperative length of hospital stay.|||days||Standard Deviation|Mean
1394222|NCT01317095|Secondary|Length of ICU Stay|Length of postoperative intensive care unit stay.|ICU stay|Postoperative average intensive care unit stay (hours)|||hours||Standard Deviation|Mean
1394223|NCT01317095|Secondary|Pain Scores.|One of the secondary outcomes are monitoring the patient’s pain scores from postoperative day 1 till day 5.|5 days after surgery|Likert Pain Scale from 0-10 (0: no pain; 10:worst possible pain)|||score on a scale||Standard Deviation|Mean
1394224|NCT01317095|Primary|Intubation Time|The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure|48 hours after surgery|Intubation time|||hours||Standard Deviation|Mean
1394225|NCT01317004|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. A lower score and a negative change from baseline indicate improvement.|6 months|Participants from the safety set, who had values at month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
1394259|NCT01316926|Primary|Area Under the Curve_steady-state|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_steady-state (ss) is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanogram; h, hour; ml, milliliter. ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study|||ng/h/ml||Standard Deviation|Mean
1394226|NCT01317004|Secondary|Change From Baseline in Patient-reported Health Related Quality of Life (QOL)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, pain, general health, energy/fatigue, social functioning, role limitations due to emotional problems and emotional well-being. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1394227|NCT01317004|Secondary|Change From Baseline in Patient-reported Depression|The Beck Depression Inventory Fast Screen (BDI-FS) is a brief, multiple choice, self reported inventory designed to evaluate depression in patients with medical illness. The BDI-FS score was calculated summing the 7 items of the questionnaire. Each item ranged from 0 (not present) to 3 (severe). The total score ranges from 0-3 (minimal depression), 4-8 (mild depression), 9-12 (moderate depression) and 13-21 (severe depression). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1394228|NCT01317004|Secondary|Change From Baseline in Patient–Reported Effectiveness and Convenience|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1394229|NCT01317004|Secondary|Change From Baseline in Patient-reported Fatigue|The fatigue Severity Scale (FSS) is a 9-item scale used to assess fatigue. The FSS score was calculated summing the 9 items of the questionnaire and dividing by the number of non-missing items (each item is based on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree)). A negative change from baseline indicates improvement.|6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1394230|NCT01317004|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL)|The PRIMUS activity measure is a 15-item assessment used to evaluate patient-reported activities of daily living. The PRIMUS activities score was calculated summing the 15 items, after recoding the responses from 1 - 3 to 0 - 2. Therefore, the total score ranged from 0 - 3-, where high scores were indicative of greater function limitation. A negative change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1394231|NCT01317004|Primary|Change From Baseline in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|baseline, 6 months|Participants from the safety set, who had values at both baseline and month 6, were included in the analysis. The safety set included randomized participants who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1394232|NCT01316939|Secondary|Change From Baseline in Faecal Calprotectin at Weeks 28 and 52|Stool sample for faecal calprotectin were to be collected at Weeks 28 and 52 visit if applicable. Data for Change from baseline in faecal calprotectin at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in faecal calprotectin at Weeks 28 and 52 was not collected.||||||
1394233|NCT01316939|Secondary|Change From Baseline in C Reactive Protein (CRP) at Weeks 28 and 52|C-reactive protein (CRP) at was to be assessed at Weeks 4, 8, 12, 20, 28, 36, 44, 52 visit if applicable. Data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0 and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52 was not collected.||||||
1394311|NCT01316419|Secondary|Percentage of Patients Achieving SBP/DBP < 130/80 mmHg Among Patients With Diabetes or Kidney Disease|Percentage of patients achieving SBP/DBP < 130/80 mmHg among patients with diabetes or kidney disease|24±2 weeks|All patients with diabetes, kidney disease or both (diabetes + kidney disease)|||percentage of participants|||Number
1394234|NCT01316939|Secondary|Change From Baseline in Health-related Resource Utilization at Weeks 28 and 52|Healthcare related resource utilization was to include: Hospitalizations (all cause and Crohn’s disease related), Length of stay, Surgical procedures (all cause and Crohn’s disease related), Outpatient visits (all cause and Crohn’s disease related ). The frequency of hospitalizations, surgical procedures and hospital out-patient visits were to be recorded at Weeks 28 and 52. The number and percentage of participants reporting all cause and Crohn’s disease -related hospitalizations, surgeries, and hospital out-patient visits were to be summarized and compared between each GSK1605786A dose group and placebo using Fisher’s exact test. Data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in health-related resource utilization at Weeks 28 and 52 was not collected.||||||
1394235|NCT01316939|Secondary|Receipt of Disability Benefits at Weeks 28 and 52|Receipt of disability benefits (Yes/No) was to be recorded at Weeks 0, 28 and 52 and Early Withdrawal visit if applicable. Change from baseline in receipt of disability benefits was to be compared between participants in remission versus participants not in remission using a Wilcoxon rank sum test. Data for Receipt of disability benefits at Weeks 28 and 52 was not collected following early termination of this study.|Weeks 28 and 52|ITT population. Following early termination of study CCX114157 data for Receipt of disability benefits at Weeks 28 and 52 was not collected.||||||
1394236|NCT01316939|Secondary|Change From Baseline in Work Productivity & Activity Impairment – Crohn’s Disease (WPAI-CD) at Weeks 28 and 52|WPAI measures the effect of your CD on your ability to work and perform regular activities. 6-items assess impairment in work productivity and daily activity during the 7 days before the assessment. It measures the percentage of overall impairment in work productivity and daily activity due to CD. A WPAI score of 0% = no impairment and a score of 100% = total loss of work productivity or activity. An absolute change in WPAI score of 7% is considered the minimum clinically important difference (MCID). Data for change from Baseline in WPAI-CD at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in Work productivity & activity impairment – Crohn’s disease (WPAI-CD) at Weeks 28 and 52 was not collected.||||||
1394237|NCT01316939|Secondary|Change From Baseline in European Quality of Life (EuroQol ) Five Dimensions Questionnaire (EQ-5D) at Weeks 28 and 52|EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0–100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL). Data for Change from Baseline in EuroQol five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in European Quality of Life (EuroQol ) five dimensions questionnaire (EQ-5D) at Weeks 28 and 52 was not collected.||||||
1394238|NCT01316939|Secondary|Change From Baseline in Short Form – 36 Version 2 (SF-36 v2) at Weeks 28 and 52|The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). SF-36 v2 items are scored such that a higher score indicates a better health state and better functioning. Data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected following early termination of this study. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 28 and 52|ITT Population. Following early termination of study CCX114157 data for change from Baseline in SF-36 v2 at Weeks 28 and 52 was not collected.||||||
1394239|NCT01316939|Secondary|Number of Participants With 12 Lead Electocardiogram (ECG) Abnormalities at Week 28 and 52|A 12 lead ECG was collected at Weeks 28 and 52. ECG abnormalities were characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). A-NCS data for Week 28 and 52 have been presented.|Week 28 and 52|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1394240|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Alanine Amino Transferase, Aspartate Amino Transferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Liver function test parameters included alanine amino transferase, aspartate amino transferase, alkaline phosphatase and gamma glutamyl transferase. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.|||units per liter||Standard Deviation|Mean
1394241|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Albumin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Liver function test parameter included albumin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
1398812|NCT01274559|Primary|Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1394242|NCT01316939|Secondary|Change From Baseline in Liver Function Test Parameter Total Bilirubin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.|Liver function test parameter included total bilirubin. Assessments were carried out at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.|Safety Population. Only those participants available at the specified time points were analyzed|||micromoles per liter||Standard Deviation|Mean
1394243|NCT01316939|Secondary|Number of Participants With Shift From Baseline in Clinical Chemistry Parameters|Clinical chemistry parameters included total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma glutamyl transferase, total bilirubin, direct bilirubin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, blood urea nitrogen (BUN)/Urea, creatinine, uric acid, lactate dehydrogenase, bicarbonate, cholesterol and creatinine kinase. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in clinical chemistry parameters characterized as high and low have been presented.|Upto Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1394244|NCT01316939|Secondary|Number of Participants With Shift From Baseline in Hematology Parameters|Hematology parameters included platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hematocrit, red blood cell count, hemoglobin, white blood cell count and segmented neutrophils . Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44 and 52 and 56. The consolidated data for number of participants with shift from Baseline (change from Baseline) in hematology parameters characterized as high and low have been presented.|Upto Week 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1394245|NCT01316939|Secondary|Change From Baseline in Vital Sign Heart Rate Upto Week 56|Vital sign assessment included heart rate collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56|Safety Population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1394246|NCT01316939|Secondary|Change From Baseline in Vital Sign Systolic Blood Pressure Systolic (SBP) and Diastolic Blood Pressure (DBP) Upto Week 56|Vital sign assessments included SBP and DBP collected in supine position following 5 minutes of rest. Assessments were carried out at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and Week 56. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1394247|NCT01316939|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Upto 56 weeks|The Safety Population comprised of all participants in the ITT population except those who did not take at least one dose of investigational product.|||Participants|||Count of Participants
1394248|NCT01316939|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52|The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The IBDQ questionnaire was to be completed by each participant at baseline and at Weeks 28, and 52. The response to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better quality of life. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Week 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 52 was not collected.||||||
1394249|NCT01316939|Secondary|Change From Baseline in CDAI Score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52|The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. CDAI scores and changes in CDAI scores during the 52-week treatment period were to be summarized by treatment group at Weeks 4, 8, 12, 20, 28, 36, 44, and 52. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease. Baseline was defined as value at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.|Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52|ITT Population. Following early termination of study CCX114157 data for Change from Baseline in CDAI score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52 was not collected.||||||
1394375|NCT01316263|Secondary|Maximum Concentration (Cmax)||Day 1 of Cycles 1 and 3 (14-day cycles)|All participants who had evaluable pharmacokinetic (PK) Cmax results at the specific time point. Due to the limited data, Cmax is not representative of the study population.|||nanograms per milliliter (ng/mL)||Full Range|Mean
1394250|NCT01316939|Secondary|Time to Induction of Clinical Remission in Participants Who Had Achieved Clinical Response During Induction Therapy But Were Not in Clinical Remission at Baseline|The duration of time participants maintained clinical remission during the 52-week treatment period was to be defined as the time between Week 0 and the first visit where remission was not observed in those participants in remission at baseline. These time periods were to be summarized by treatment group using quartiles and their corresponding confidence intervals. Comparisons between each GSK1605786A dose group and placebo were to be made using log-rank tests. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Upto Week 52|ITT Population. Following early termination of study CCX114157 data for Time to induction of clinical remission in participants who had achieved clinical response during induction therapy but were not in clinical remission at Baseline was not collected.||||||
1394251|NCT01316939|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease >=100 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical response is defined as a reduction from the induction study baseline CDAI score of >=100 points. The percentage of participants with a clinical response at both Weeks 28 and 52 of the 52-week maintenance treatment period in the ITT population using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher’s exact test. Participants with missing CDAI scores were to be considered non-responders according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Week 28 and 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants with a clinical response (CDAI decrease >=100 points) at both Weeks 28 and 52 of the 52-week treatment period was not collected.||||||
1394252|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at Week 52|The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Week 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at Week 52 was not collected.||||||
1394253|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at All Visits (Continuous Clinical Remission) During the 52-week Treatment Period Among Participants in Clinical Remission at Baseline|The percentage of participants with clinical remission at all visits during the 52-week treatment period were to be summarized by treatment group for the subset of participants in remission at baseline, using the no effect imputation for missing data. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. Comparisons between each GSK1605786A dose group and placebo were to be made using Fisher’s exact test.The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Upto Week 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at all visits (continuous clinical remission) during the 52-week treatment period among participants in clinical remission at Baseline was not collected.||||||
1394254|NCT01316939|Secondary|Percentage of Participants in Clinical Remission at Both Weeks 28 and 52 of the 52-week Treatment Period Among Those Participants Who Were in Clinical Remission at Baseline|Clinical remission is defined as a CDAI score <150 points. Among participants in remission at baseline, the percentage of participants with clinical remission at both Weeks 28 and 52 of the treatment period using the no effect imputation for missing data were to be compared between each GSK1605786A dose group and placebo using Fisher’s exact test. Participants with missing CDAI scores were to be considered not to be in remission according to the missing=no effect imputation. The limited data resulting from early termination of Study CCX114157 did not allow any conclusions to be drawn about the efficacy of GSK1605786A in the maintenance of clinical remission in participants with Crohn’s disease.|Week 28 and 52|ITT Population. Following early termination of study CCX114157 data for Percentage of participants in clinical remission at both Weeks 28 and 52 of the 52-week treatment period among those participants who were in clinical remission at Baseline was not collected.||||||
1394255|NCT01316939|Secondary|Percentage of Participants in Clinical Remission (CDAI Score <150 Points) and Not Taking Corticosteroids at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical remission is defined as a CDAI score <150 points. A participant was considered to be not taking corticosteroids at Weeks 28 and 52 if the participant had not taken a corticosteroid for the 8 days prior to and the day of the CDAI assessment for each of Weeks 28 and 52. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period have been presented.|Week 28 and 52|ITT Population.|||Percentage of Participants|||Number
1394256|NCT01316939|Primary|Percentage of Participants in Clinical Remission (Crohn’s Disease Activity Index , CDAI Score <150 Points) at Both Weeks 28 and 52 of the 52-week Treatment Period|Clinical remission is defined as a CDAI score <150 points. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in at both Weeks 28 and 52 of the 52-week treatment period have been presented.|Week 28 and 52|The Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment who achieved a clinical response (CDAI decrease from baseline of >=100 points) or achieved clinical remission (CDAI <150 points).|||Percentage of Participants|||Number
1394257|NCT01316926|Primary|Cmax_steady-state|Cmax_steady-state (ss) is defined as the maximum or “peak” concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
1394258|NCT01316926|Primary|Cmin_steady-state|Cmin_steady-state (ss) is defined as the minimum concentration of a drug observed after its administration in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (Period 1) and Days 23 to 24 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
1394260|NCT01316913|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||scores on a scale||Standard Error|Least Squares Mean
1394261|NCT01316913|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394262|NCT01316913|Primary|Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.|Baseline and Day 169|ITT Population: all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394263|NCT01316900|Other Pre-specified|Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|ITT Population excluding participants from Investigator 040688. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1394264|NCT01316900|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population excluding participants from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394273|NCT01316887|Secondary|Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Beats per minute||Standard Deviation|Mean
1394265|NCT01316900|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants. .|Baseline and Day 169|ITT Population excluding par. from Investigator 040688: all randomized par. who received >=1 dose of study drug, except for those from Investigator 040688. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394266|NCT01316887|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning’s dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions.|Baseline; Months 1, 3, 6, 9, and 12|ITT Population. The overall number of participants reflects all participants who provided at least one post-treatment assessment. Participants who provided data the specified time points are represented by n=X, X, X in the category titles.|||Liters||Standard Error|Least Squares Mean
1394267|NCT01316887|Secondary|Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period|Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline.|From the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the summary.|||Percentage of rescue-free days||Standard Deviation|Mean
1394268|NCT01316887|Secondary|Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period|Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + [2 * number of salbutamol nebules] + [2 * number of ipratropium nebules]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group.|Baseline; from the start of study drug up to 52 weeks|ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the analysis.|||Number of puffs per day||Standard Error|Least Squares Mean
1394269|NCT01316887|Secondary|Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation|"Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An any time post-Baseline Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists."|Screening; from the start of study drug up to 52 weeks|ITT Population. Only those participants providing at least one post-Baseline interpretation were summarized.|||Participants|||Number
1394270|NCT01316887|Secondary|Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline|Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists.|From the start of study drug up to 52 weeks|ITT Population|||participants|||Number
1394271|NCT01316887|Secondary|Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Beats per minute||Standard Deviation|Mean
1394272|NCT01316887|Secondary|Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett’s Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia’s Formula (QTcF), and PR Interval Over the Course of the 52-week|12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Milliseconds||Standard Deviation|Mean
1394274|NCT01316887|Secondary|Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period|Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; from the start of study drug up to 52 weeks|ITT Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1394275|NCT01316887|Secondary|Change From Baseline in Hematocrit at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1394276|NCT01316887|Secondary|Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1394277|NCT01316887|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Percentage in blood||Standard Deviation|Mean
1394278|NCT01316887|Secondary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1394279|NCT01316887|Secondary|Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1394280|NCT01316887|Secondary|Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1394308|NCT01316419|Secondary|Mean Blood Lipid Change - Triglyceride|Mean blood lipid change - Triglyceride|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
1394281|NCT01316887|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12|"Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the Baseline value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit."|Baseline; Months 3, 6, 9, and 12|ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1394282|NCT01316887|Secondary|Time to the First On-treatment COPD Exacerbation|An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants.|From the start of study drug up to 52 weeks|ITT Population|||Days||Full Range|Median
1394283|NCT01316887|Secondary|Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period|A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.|From the start of study drug up to 52 weeks|ITT Population|||Participants|||Number
1394284|NCT01316887|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of study drug up to 52 weeks|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug|||Participants|||Number
1394285|NCT01316692|Other Pre-specified|Correlation Between MLN8237-induced Selective Aurora Kinase A Inhibition in Post-treatment Tumor Sites and Clinical Benefit of MLN8237|In stage 2 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Post-treatment tumor tissue will be assayed for MLN8237-induced selective Aurora Kinase A inhibition and compared to pre-treatment tumor tissue and the results will be compared and contrasted with patients’ objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|unable to collected the required number of tumor samples||||||
1394286|NCT01316692|Other Pre-specified|Characterize the de Novo Molecular Mutation Profile of the Melanomas for Association Between Objective Responses to MLN8237 in Patients With Pre-treatment Melanoma Tissue.|In stage 1 patients: tumor biopsies are taken before initiation of treatment and on the 8th day of the first cycle of treatment. Tissue will be assayed for mutations that are neither parent-possessed, nor able to be transmitted, in pre- and in post-treatment tissue and the results will be compared and contrasted with patients’ objective clinical responses, as determined by RECIST 1.1, after 18 weeks of treatment|At 24 weeks|Collected samples of tumors were very limited. It did not allow us to perform the described assays||||||
1394287|NCT01316692|Secondary|Number of Grade 3 and 4 Study-related Toxicities|Event are graded using National Cancer Institute Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death. toxicities measured on day 1 of each 21-day cycle. Treatment continues to disease progression, toxicity, or withdrawal for other reasons.|at 18 weeks|total numbers of adverse events, patients experiencing grade 3 and 4 related to study treatment|||toxicities|||Number
1394288|NCT01316692|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details) Evaluated every 3 months for 12 months, then every 6 months|On treatment date to last follow-up or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1394289|NCT01316692|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the duration in time from start of therapy to last follow-up, disease progression, or death for any reason.measured every 6 weeks for 24 weeks, and then every 12 weeks or to last date known alive or death, determined every 6 months for up to 5 years. For those who are alive and without progression, they are censored at the last date known alive.|On treatment date to last follow-up, disease progression or death for any reason, up to 5 years|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1394309|NCT01316419|Secondary|Mean Blood Lipid Change - High Density Lipoprotein (HDL)-Cholesterol|Mean blood lipid change from baseline - high density lipoprotein (HDL)-Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
1394290|NCT01316692|Primary|Overall Response Rate|If 2 or more of 23 pts show CR/PR in stage 1, then an additional 33 pts will be enrolled in stage 2. If 6 or more of the total 56 pts show CR/PR at 18 weeks, then further clinical trials will be warranted. Per Response Evaluation Criteria in Solid Tumor (RECIST)1.1: Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|At 18 weeks|All patients with Objective Response, defined as a complete or partial response.|||participants||95% Confidence Interval|Number
1394291|NCT01316614|Secondary|Amount of Blood||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
1394292|NCT01316614|Secondary|Contamination|Percentage of area of slide that represents GI contamination|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
1394293|NCT01316614|Secondary|Adequacy of Specimen||At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
1394294|NCT01316614|Secondary|Degree of Cellularity|Number of cells per slide|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
1394295|NCT01316614|Secondary|Degree of Cellularity|Percentage of area of slide that contains cells of the representative lesion|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
1394296|NCT01316614|Primary|Compare Adequacy of Diagnoses in Passes With and Without a Stylet|"The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet.~There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes."|At the time of EUS-FNA procedure (Day 1)|100 participants were analyzed. Each participant had an equal number of passes with a stylet and without a stylet. 275 overall passes were performed with a stylet and 275 passes were performed without a stylet. The actual passes are represented in the table.|||passes|||Number
1394297|NCT01316575|Secondary|Length of Stay in Hospital||Up to 2 weeks||||days||Standard Deviation|Mean
1394298|NCT01316575|Secondary|Number of Participants Requiring Admission to ICU||Up to 2 weeks||||participants|||Number
1394299|NCT01316575|Secondary|Number of Participants Requiring Reintubation||Up to 2 weeks||||participants|||Number
1394300|NCT01316575|Primary|Alveolar - Arterial Gradient|The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen|1 hour following admission to PACU|From the literature, a sample size of 19 subjects per group is required for a power >0.9 and alpha <0.05 assuming a normalised difference in A-a gradient between groups of 0.33 and a Standard Deviation (SD) of 0.33|||torr||Standard Deviation|Mean
1394301|NCT01316510|Secondary|Length of Hospital Stay|Number of days from surgery until discharge|Initial discharge from the hospital||||days||Standard Deviation|Mean
1394302|NCT01316510|Primary|Composition of the Fecal Microbiota|"Stools will be collected from messy diapers.~Percentage bifidobacteria = total bifidobacteria per Group divided by the total bacteria per Group multiplied by 100% Percentage clostridia = total clostridia per Group divided by the total bacteria per Group multiplied by 100%"|Final stool sample at 6 weeks|Final stool sample|||percentage of total bacteria|||Number
1394303|NCT01316419|Secondary|Incidence and Severity of Reported Adverse Events.|Incidence as per the severity of reported adverse events is presented.|24±2 weeks|Patients having received at least one dose of Twynsta tablets|||participants|||Number
1394304|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 24±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.|||percentage of participants|||Number
1394305|NCT01316419|Secondary|Percentage of Patients Who Complied With Each Category of Lifestyle Modification Recommendations at 12±2 Weeks|Percentage of patients who complied with each category of lifestyle modification recommendations at 12±2 weeks|12±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.|||percentage of participants|||Number
1394306|NCT01316419|Secondary|Percentage of Patients Achieving Normal Body Mass Index (BMI)|Percentage of patients achieving normal BMI (18.5 kg/sq.m to 24.9 kg/sq.m) are presented|24±2 weeks|Patients with a baseline and an endpoint BMI together with evaluation record on recommendations for lifestyle modifications.|||percentage of participants|||Number
1394307|NCT01316419|Secondary|Mean Blood Lipid Change - Total Cholesterol|Mean blood lipid change - Total Cholesterol|baseline and 24±2 weeks|Patients with medical history of hyperlipidemia and who have a baseline and an endpoint lipid profile measurement together with evaluation record on recommendations for lifestyle modifications.|||mg/dl||Standard Deviation|Mean
1394312|NCT01316419|Secondary|EuroQol (EQ) Visual Analogue Scale (VAS)|The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled ‘best imaginable health state’ and ‘worst imaginable health state. The scale goes from 0 to 100, a low value shows better physical health.|baseline and 24±2 weeks|Patients with a baseline and an endpoint EQ VAS response|||scores on a scale||Standard Deviation|Mean
1394313|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Overall|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
1394314|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Environment Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
1394315|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Social Relationships Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
1394316|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Psychological Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||scores on a scale||Standard Deviation|Mean
1394317|NCT01316419|Secondary|Change From Baseline of Quality of Life Assessment Data Measured by World Health Organization Quality of Life (WHOQOL-BREF)- Physical Health Domain|"WHOQOL-BREF, an abbreviated 26 item version of the WHOQOL-100 was developed to enable a brief but accurate assessment of the quality of life.~The Korean version of WHOQOL-BREF is valid and reliable in the assessment of quality of life in Koreans. The WHOQOL-BREF is based on the four domain structure (physical health, psychological, social relationships, and environment). It was designed to use 5-point scales for all questions (not at all, a little, moderately, mostly, and completely). The scale goes from 4 to 20 in each domain structure and 0 to 5 in overall score, a low value shows better physical health."|baseline and 24±2 weeks|Patients with a baseline and an endpoint WHOQOL-BREF response|||scores on a scale||Standard Deviation|Mean
1394318|NCT01316419|Secondary|Percentage of Patients Achieving SBP Response|Percentage of patients achieving SBP response (defined as mean seated SBP < 140 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||percentage of participants|||Number
1394319|NCT01316419|Primary|Mean Blood Pressure Change Diastolic Blood Pressure (DBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change DBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||mmHg||Standard Deviation|Mean
1394320|NCT01316419|Secondary|Percentage of Patients Achieving DBP Response|Percentage of patients achieving DBP response (defined as mean seated DBP < 90 mmHg or a drop of ≥ 10 mmHg) is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||percentage of participants|||Number
1394321|NCT01316419|Secondary|Percentage of Patients Achieving Target Blood Pressure SBP/DBP <140/90 mmHg.|Percentage of patients achieving target blood pressure SBP/DBP <140/90 mmHg is a key secondary endpoint.|24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||percentage of participants|||Number
1394322|NCT01316419|Primary|Mean Blood Pressure Change Systolic Blood Pressure (SBP) From Baseline After 24±2 Weeks of Treatment or at the Last Observation in Case of Early Withdrawal.|"The primary endpoint is the mean blood pressure change SBP from baseline after 24±2 weeks of treatment or at the last observation in case of early withdrawal.~Baseline is defined as data collected on baseline visit."|baseline and 24±2 weeks|All patients with a baseline and an endpoint blood pressure measurement.|||mmHg||Standard Deviation|Mean
1394386|NCT01316224|Secondary|Percentage of Participants With Joint Symptoms|Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
1394323|NCT01316380|Secondary|Use of Rescue Medication During Nighttime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.|||puffs of rescue medication||Standard Error|Mean
1394324|NCT01316380|Secondary|Use of Rescue Medication During Daytime|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.|||puffs of rescue medication||Standard Error|Mean
1394325|NCT01316380|Secondary|Use of Rescue Medication During 24h Period|"Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.~The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week."|Baseline and 12 weeks|All patients from FAS.|||puffs of rescue medication||Standard Error|Mean
1394326|NCT01316380|Secondary|Time to First Asthma Exacerbation During the 12-week Treatment.|An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms.|12 weeks|All patients from FAS.|||Days||Inter-Quartile Range|Median
1394327|NCT01316380|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment.|Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days.|12 weeks|All patients from FAS.|||Days||Inter-Quartile Range|Median
1394328|NCT01316380|Secondary|Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment|For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline <= -0.5), no change (-0.5 <change from baseline < 0.5) and worsening (change from baseline >= 0.5).|12 weeks|All patients from FAS.|||Number of patients|||Number
1394329|NCT01316380|Secondary|FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
1394330|NCT01316380|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
1394331|NCT01316380|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
1394332|NCT01316380|Secondary|Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from FAS.|||Liter||Standard Error|Least Squares Mean
1394333|NCT01316380|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 12 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who received at least one dose of randomized trial medication.|||Liter||Standard Error|Least Squares Mean
1394334|NCT01316341|Primary|Fasting Plasma Glucose (FPG) Change From Baseline|Fasting Plasma Glucose (FPG) change from baseline between day 1 and day 9.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.|||mg/dL||Standard Deviation|Mean
1394335|NCT01316341|Primary|Urinary Glucose Excretion (UGE) Change From Baseline|Change from day -1 in urinary glucose excretion in a 24 hour collection period per time point.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacodynamic analysis (PD) set included all patients documented to have taken at least one dose of investigational treatment, who received at least one dose of empagliflozin or placebo and who provided at least one baseline and post-treatment observation for at least one PD endpoint.|||mg||Standard Deviation|Mean
1394336|NCT01316341|Secondary|Clinical Relevant Abnormalities for Protocol-Specified Significant Adverse Events, Hypoglycaemic Events, Vital Signs, Blood Chemistry, Rescue Therapy, Body Weight and Waist Circumference|"Clinically relevant abnormalities for protocol-specified significant adverse events, hypoglycaemic events, vital signs, blood chemistry, use of rescue therapy, change in body weight and change in waist circumference.~Results shown are for hypoglycaemic events, as this was the only event that occurred for this endpoint."|Drug administration until end of trial, up to 21 days|Treated set (TS) includes all patients who were documented to have taken at least one dose of investigational treatment.|||participants|||Number
1394337|NCT01316341|Primary|Predose Plasma Concentration Before Planned Dose x (Cpre,x)|"Predose plasma concentration of empagliflozin (empa) before planned dose by day.~This endpoint in steady state is identical to Cmin,ss."|5 minutes before drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1394338|NCT01316341|Primary|Accumulation Ratio Based on Cmax (R A,Cmax)|Accumulation ratio of empagliflozin (empa) based on Cmax, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration between days 5 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1394339|NCT01316341|Primary|Accumulation Ratio Based on AUC (R A,AUC)|Accumulation ratio of empagliflozin (empa) based on AUC, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, and16h after drug administration on days 1 and 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1394340|NCT01316341|Primary|Renal Clearance at Steady State (CL R,ss)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1394341|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine at Steady State in the Time Interval 0 Hours to 24 Hours (fe 0-24,ss)|Fraction of empagliflozin (empa) excreted unchanged in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
1394342|NCT01316341|Primary|Amount of Analyte Eliminated in Urine at Steady State in Time Interval 0 Hours to 24 Hours (Ae 0-24,ss)|Amount of empagliflozin (empa) eliminated in urine at steady state in the time interval 0 hours to 24 hours, after multiple dosing.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol||Geometric Coefficient of Variation|Geometric Mean
1394343|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/Fss)|Apparent volume of distribution during the terminal phase λz at steady state following oral administration after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||L||Geometric Coefficient of Variation|Geometric Mean
1394344|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/Fss)|Apparent clearance of empagliflozin (empa) in the plasma at steady state following multiple oral dose administration.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1394345|NCT01316341|Primary|Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of empagliflozin (empa) in the body at steady state after multiple oral administrations|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
1394346|NCT01316341|Primary|Terminal Half-life in Plasma at Steady State (t1/2,ss)|Terminal half-life of empagliflozin (empa) in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
1394418|NCT01315353|Secondary|Percentage of Participants With Targeted Adverse Events (AEs) Reported Post Cryotherapy in Arm A.|Cryotherapy was performed in Arm A within 7 days of study entry. Targeted AEs four weeks after cryotherapy is provided in the data table below. The AE categories are not mutually exclusive. A participant may have experienced AEs and may be counted in more than one category.|4 weeks post cryotherapy|Included Arm A participants who had cryotherapy.|||percentage of participants|||Number
1394347|NCT01316341|Primary|Terminal Rate Constant in Plasma at Steady State (λz,ss)|Terminal rate constant in plasma at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1394348|NCT01316341|Primary|Area Under the Concentration-time Curve in Plasma at Steady State Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of empagliflozin (empa) in plasma at steady state over a uniform dosing interval, after multiple dosing|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1394349|NCT01316341|Primary|Time From Last Dosing to Maximum Measured Concentration Over a Uniform Dosing Interval at Steady State (Tmax,ss)|Time from last dosing to maximum measured concentration of empagliflozin (empa) in plasma over a uniform dosing interval at steady state, after multiple dosing.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
1394350|NCT01316341|Primary|Maximum Measured Concentration Over a Uniform Dosing Interval (Cmax,ss)|Maximum measured concentration of empagliflozin (empa) in plasma at steady state over a uniform dosing interval.|5 minutes (min) before drug administration and 10min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h 48h, 60h, 72h and 96h after drug administration on day 9|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1394351|NCT01316341|Primary|Renal Clearance After Extravascular Administration (CL R,0-48)|Renal clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1394352|NCT01316341|Primary|Fraction of Empagliflozin Excreted Unchanged in Urine in the Time Interval 0 Hours to 24 Hours (fe 0-24).|Fraction of empagliflozin (empa) excreted unchanged in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||percentage of empa||Geometric Coefficient of Variation|Geometric Mean
1394353|NCT01316341|Primary|Amount of Empagliflozin Eliminated in Urine in the Time Interval 0 Hours to 24 Hours (Ae 0-24)|Amount of empagliflozin (empa) eliminated in urine in the time interval 0 hours to 24 hours, after the first dose on day 1.|Sampling intervals were 0-2 hours (h), 2-4h, 4-8h, 8-12h and 12-24h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol||Geometric Coefficient of Variation|Geometric Mean
1394354|NCT01316341|Primary|Apparent Volume of Distribution During the Terminal Phase λz (Vz/F)|Apparent volume of distribution during the terminal phase λz, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||L||Geometric Coefficient of Variation|Geometric Mean
1394355|NCT01316341|Primary|Apparent Clearance of Empagliflozin After Extravascular Administration (CL/F)|Apparent clearance of empagliflozin (empa) in plasma after extravascular administration, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1394356|NCT01316341|Primary|Mean Residence Time (MRTpo)|Mean residence time of empagliflozin (empa) in the body after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
1394357|NCT01316341|Primary|Terminal Half-life (t1/2)|Terminal half-life of empagliflozin (empa) in plasma after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
1394358|NCT01316341|Primary|Terminal Rate Constant (λz)|Terminal Rate Constant in Plasma (λz), after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1394359|NCT01316341|Primary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1394360|NCT01316341|Primary|Area Under the Curve 0 to Infinity (AUC0-∞) After Single Dosing|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity, after the first dose on day 1|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1394361|NCT01316341|Primary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to the maximum measured concentration of the analyte in plasma, after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
1394362|NCT01316341|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma after the first dose on day 1.|5 minutes (min) before drug administration and 10 min, 20min, 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 16h after drug administration|Pharmacokinetic (PK) analysis set included all evaluable patients documented to have taken at least one dose of investigational treatment and who provided at least one observation for at least one PK endpoint.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1394363|NCT01316315|Other Pre-specified|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing||7 Days|Any patient that received a dose of N6022 or Placebo|||mg/mL||Standard Error|Mean
1394364|NCT01316315|Secondary|To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.|Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed.|10 Weeks|Any patient that received a dose of N6022 or placebo|||Adverse Events|||Number
1394365|NCT01316315|Secondary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|8 hours|Any patient that received a dose of N6022 or Placebo|||mg/mL||Standard Error|Mean
1394366|NCT01316315|Primary|Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing|These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.|24 hours|Any patient that received a dose of N6022 or placebo.|||mg/mL||Standard Error|Mean
1394367|NCT01316302|Secondary|Patient Global Impression of Change|Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders.|Baseline to study endpoint (Week 12)||||percentage of self-rated responders|||Number
1394368|NCT01316302|Secondary|Clinical Global Impression of Improvement Scale (CGI-I)|CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint.|Baseline to Week 12||||% of subjects who were CGI-I responders|||Number
1394369|NCT01316302|Primary|Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score|Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms.|Baseline to study endpoint (Week 12)|The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1).|||Scores on a scale||Standard Deviation|Mean
1394370|NCT01316263|Secondary|Percentage of Participants With Human Anti-Olaratumab (IMC-3G3) Antibody Results|Participants with Treatment Emergent (TE) anti-olaratumab (IMC-3G3) antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Day 1 of Cycles 1, 3, 6, 12 and 18 prior to infusion (14-day cycles)|All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.|||percentage of participants|||Number
1394371|NCT01316263|Secondary|Volume of Distribution at Steady State (Vss)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. Vss was not reported. Vss could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
1394372|NCT01316263|Secondary|Clearance (CL)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. CL was not reported. CL could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
1394373|NCT01316263|Secondary|Half Life (t½)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. t1/2 was not reported. t1/2 could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
1394374|NCT01316263|Secondary|Area Under the Curve (AUC)||Day 1 of Cycles 1 and 3 (14-day cycles)|Zero participants were analyzed. AUC was not reported. AUC could not be calculated due to an insufficient number of olaratumab serum concentrations.||||||
1394376|NCT01316263|Secondary|Percentage of Participants With CR, PR or SD [Disease Control Rate (DCR)]|DCR defined as CR, PR or SD using RECIST v1.1 criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify PD, taking as reference the smallest sum diameter since the treatment started. PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. Percentage of participants=(number of participants with CR+PR+SD/number of participants in group) * 100.|Baseline up to 35.9 weeks|All participants who received any study drug.|||percentage of participants||90% Confidence Interval|Number
1394377|NCT01316263|Secondary|Number of Participants With Adverse Events (AE) and Participants Who Died|Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. The number of participants who died due to an AE or disease progression are also reported.|Baseline up to 57.3 weeks and 30-day post study-discontinuation follow-up|All participants who received any study drug.|||participants|||Number
1394378|NCT01316263|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose of study drug to the date of death from any cause. Participants who were alive at the end of the post-study follow-up or were lost to follow-up were censored on the last date the participant was known to be alive.|Date of first dose of study drug to the date of death from any cause up to 57.3 weeks|All participants who received any study drug. Participants censored: PDGFRα Mutant=4, PDGFRα Wild-type=4.|||weeks||90% Confidence Interval|Median
1394379|NCT01316263|Secondary|Percentage of Participants With CR or PR [Radiographic Objective Response Rate (ORR)]|The ORR was the best overall response of CR and PR using RECIST, v1.1 criteria. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator that calculated the response rate. Percentage of participants = (number of participants achieving a response/total of participants treated) * 100.|Baseline up to 35.9 weeks and post study discontinuation 30-day follow-up|All participants who received any study drug.|||percentage of participants||90% Confidence Interval|Number
1394380|NCT01316263|Secondary|Progression-Free Survival (PFS)|PFS defined as the duration from date of first dose of study drug until first radiographic documentation of PD using RECIST, v1.1 criteria or death from any cause. PD defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. Participants who died with no prior PD were considered to have progressed on day of death. Participants who did not progress or were lost to follow-up were censored at date of last radiographic tumor assessment; if no assessment was available censoring was at date of registration. If death or PD occurred after 2 consecutive missing radiographic visits censoring was date of last radiographic visit prior to missed visits. Use of new anticancer therapy prior to PD, censoring was date of last radiographic assessment prior to new therapy.|Baseline to the first date of objectively determined PD or death from any cause up to 35.9 weeks|All participants who received any study drug. Censored participants: PDGFRα Mutant=2, PDGFRα Wild-Type=0.|||weeks||90% Confidence Interval|Median
1394381|NCT01316263|Primary|Percentage of Participants With Tumor Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) at 12 Weeks|Clinical benefit was defined as CR, PR, or SD using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v1.1) criteria. CR: disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR: ≥30% decrease in sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. PD: increase ≥20% in sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or appearance of 1 or more new lesions was considered progression. Percentage of participants=(participants with CR+PR+SD/participants in group) *100.|12 weeks|All participants who received any study drug.|||percentage of participants||90% Confidence Interval|Number
1394382|NCT01316224|Secondary|Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%|This outcome measure was not calculated.|At Baseline, Week 24, and Week 48|||||||
1394383|NCT01316224|Secondary|Incidence Rate of PsA Since Psoriasis Diagnosis|"The number of new PsA cases were determined by:~PsA defined by a rheumatologist; or~A participant with inflamed joints >0 and CASPAR score >=3; or~Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA)."|Baseline up to Visit 4 (month 12)|ITT population|||new PsA cases per 100 person years||95% Confidence Interval|Number
1394384|NCT01316224|Primary|Percentage of Participants Who Developed Signs or Symptoms of PsA|Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
1394385|NCT01316224|Primary|Percentage of Participants Who Developed Psoriatic Arthritis (PsA)|"A participant is said to have PsA if they meet the following criteria:~PsA defined by a rheumatologist; or~A participant with inflamed joints >0 and CASPAR score >=3; or~Participant meeting at least one of the two previous definitions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
1394777|NCT01313182|Primary|Surgical Site Infections Occurring Within 12 Months of Surgical Procedure|Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.|12 months||||participants|||Number
1394387|NCT01316224|Secondary|Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero|"Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions."|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
1394388|NCT01316224|Secondary|Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point).|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||Percentage of participants|||Number
1394389|NCT01316224|Secondary|Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score|The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available.|||CASPAR score||Standard Deviation|Mean
1394390|NCT01316224|Secondary|Mean Change in Quality of Life (QoL)|The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL.|At Baseline, Visit 3 (month 6) and Visit 4 (month 12)|ITT population|||Score on scale||Standard Deviation|Mean
1394391|NCT01316224|Secondary|Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA|Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.|||Percentage of participants|||Number
1394392|NCT01316224|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease).|At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)|ITT population|||PASI score||Standard Deviation|Mean
1394393|NCT01316224|Secondary|Mean Time to First Occurrence of PsA Signs or Symptoms|The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.|Baseline up to Visit 4 (month 12)|Participants who completed at least one of the follow up visits to the rheumatologist.|||Years||95% Confidence Interval|Mean
1394394|NCT01316055|Secondary|The Steady State Fractional Clearance, Calculated as the Dose / AUC(0-12) (CL/Fss) of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT|||liter/hour||90% Confidence Interval|Geometric Mean
1394395|NCT01316055|Secondary|The Maximum Measured Plasma Concentration (Cmax) at Steady State, of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.||7 days|ITT|||nanogram/milliliter||90% Confidence Interval|Geometric Mean
1394396|NCT01316055|Primary|The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).|AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.|0 and 1,2,3,4,5,6,8, and 12 hours after the last dose|Intention to treat (ITT)|||hour*nanogram/milliliter||90% Confidence Interval|Geometric Mean
1394397|NCT01316042|Primary|Change in Serum DHEAS Levels|Change in DHEAS level was constructed per subject as the 1-year measurement minus the baseline measurement. Only descriptive statistics are provided, statistical tests were not conducted given the extremely small sample size per group.|1 year||||ug/dL||Full Range|Mean
1394398|NCT01315873|Secondary|Duration of Response of This Regimen.|Time from response to relapse. Response would have been assessed using European Group for Blood and Marrow Transplantation (EBMT) criteria modified to include near complete remission (nCR) and very good partial remission (VGPR|from initial response to relapse, up to 100 weeks.|Participant data was not analyzed because PI left institution||||||
1394399|NCT01315873|Secondary|Toxicity of This Regimen.|Study toxicity will be measured on an ongoing basis, no less then once per 28-day cycle.|Every 4 weeks.|Participant data was not analyzed because PI left institution. Data were not available for analysis.||||||
1394400|NCT01315873|Primary|Percent Change Response Rate (Partial Response or Better After 2 Cycles) Following Treatment With Bortezomib and Bendamustine|These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)|8 weeks|Participant data was not analyzed because PI left institution||||||
1394401|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During Period When Migraine is Absent (Interictal Phase)(Part III, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 2 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO||||||
1394402|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During a Migraine Attack (Ictal Phase)(Part III, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part III, Period 1 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO||||||
1394403|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|In Part I, Period 2 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 1, 2, 3 and 4 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part 1, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol|||μM||Standard Deviation|Mean
1394404|NCT01315847|Primary|Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 miniutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol|||percent CGRP RO|||Number
1394405|NCT01315847|Primary|Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|In Part I, Period 1 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 2, 3, 4 and 5 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.|Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol|||μM||Standard Deviation|Mean
1394419|NCT01315353|Secondary|Number of Participants With High Risk (hr)-HPV by the Roche Linear Array HPV Genotyping Test at Study Visits.|Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Roche Linear Array HPV Genotyping test. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.|Weeks 26, 52, 78, 104 and 130 post randomization|Includes participants with results for the Roche Linear Array HPV Genotyping test.|||Participants|||Count of Participants
1394420|NCT01315353|Secondary|Number of Participants With High Risk (hr)-HPV by the Xpert HPV Assay at Study Visits.|Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Xpert HPV assay. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.|Weeks 26, 52, 78, 104 and 130 post randomization|Includes participants with results for Xpert HPV assay|||Participants|||Count of Participants
1396953|NCT01292226|Primary|Time to Rejection|The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population; only participants with acute or biopsy-proven rejection were included in the analysis.|||days||Standard Deviation|Mean
1394406|NCT01315847|Primary|Brain Calcitonin Gene-related Peptide (CGRP) Receptor Occupancy (RO) Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)|Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, regions of interest (ROIs) were drawn throughout cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue time-activity curves (TACs). Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. Total volume of distribution (VT), an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. Change in VT between baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.|Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose|Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol|||percent CGRP RO|||Number
1394407|NCT01315847|Primary|Number of Participants With AEs (Part III)|Any AEs occurring among participants (all were migraine patients) in Part III of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part III of study (Up to approximately 6 months)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part III of study.|||participants|||Number
1394408|NCT01315847|Primary|Number of Participants With Adverse Events (AEs) (Part I)|Any AEs occurring among participants (all were healthy subjects) in Part I of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.|Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part I of study (Up to approximately 14 weeks)|All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part I of study.|||participants|||Number
1394409|NCT01315665|Secondary|Measure of Neutrophil Migration Into the Gingival Crevices|Change in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.|Baseline and end of 5 day treatment period||||Neutrophils/mL (Log10)||Standard Deviation|Mean
1394410|NCT01315665|Secondary|Measures of Oxidative Stress in Urine|Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period||||ng/mg creatinine (Log10)||Standard Deviation|Mean
1394411|NCT01315665|Secondary|Measures of Glutathione From Blood Lymphocytes|Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).|Baseline and end of 5 day treatment period|Not enough blood could be obtained from one of the healthy volunteers. Therefore, glutathione from blood lymphocytes could not be evaluated from that healthy volunteer. With respect to this outcome measure, only results from 9 healthy volunteers are reported.|||Micro Molar||Standard Deviation|Mean
1394412|NCT01315665|Secondary|Measures of Lipid Peroxidation in Nasal Epithelial Cells|Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)|End of 5 day treatment period|Data not collected and will not be analyzed.||||||
1394413|NCT01315665|Primary|Nrf2 Activation in Nasal Epithelial Cells|Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)|Baseline and of end of 5 day treatment period||||participants|||Number
1394414|NCT01315574|Secondary|Tear Film Break-Up Time|Tear Film Break-Up Time (TBUT) is a clinical test used to quantify changes in dry eye symptoms. The Tear Film Break-Up time is the number of seconds between the subjects last blink and the detection of the first dry spot in the tear film.|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.|||Seconds||Standard Deviation|Mean
1394415|NCT01315574|Secondary|Corneal Fluorescein Staining Score|Corneal Fluorescein Staining score was used in this study to quantify changes in dry eye symptoms. Corneal fluorescein staining scores range from 0 to 4 points: 0=non-staining to 4 =regional whole staining of the cornea. Higher scores indicate worse eye condition.|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.|||units on a scale (1-4)||Standard Deviation|Mean
1394416|NCT01315574|Primary|Effectiveness in Lowering Intraocular Pressure|Applanation tonometry will be used to measure patients' intraocular pressure|At the 6 month follow-up time point|Two subjects in each arm/group did not complete 6-month follow up visit. Data was not collected and analysis not completed.|||mmHg||Standard Deviation|Mean
1394417|NCT01315353|Secondary|Percentage of Participants With Targeted AEs Reported Post LEEP.|LEEP was performed on participants who had CIN2+. For Arm A participants, LEEP was available starting at week 26; for Arms B and C, LEEP was available starting at study entry. Targeted AEs four weeks after LEEP is provided in the data table below. The AE categories are not mutually exclusive. A participant may have experienced AEs and may be counted in more than one category.|4 weeks post LEEP|Participants in each arm who had LEEP were included in the analysis.|||percentage of participants|||Number
1394445|NCT01315158|Secondary|Number of Participants Who Experience Other Sedation Related Complications|Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups|One day (during procedure)||||participants|||Number
1394421|NCT01315353|Secondary|Number of Participants With High Risk (hr)-HPV by the Abbott Real Time High-risk HPV Assay (aHPV) at Study Visits.|Number of participants with hr-HPV (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) as detected by the Abbott Real Time high-risk HPV assay. Specimens for weeks 52, 78, 104 and 130 were not tested due to insufficient funding.|Weeks 26, 52, 78, 104 and 130 post randomization|Includes participants with results for Abbott Real Time high-risk HPV assay|||Participants|||Count of Participants
1394422|NCT01315353|Secondary|Number of Participants With Abnormal Cytology Results at Study Visits.|Number of participants with abnormal (ASCUS: atypical squamous cells; undetermined significance, ASC-H: atypical squamous cells; favor high-grade squamous intra-epithelial lesion, LSIL: low-grade squamous intraepithelial lesion/mild dysplasia/HPV, HSIL: high-grade squamous intraepithelial lesion/moderate or severe dysplasia/carcinoma in situ/features of invasion; squamous cell carcinoma) cytology results.|Weeks 26, 52, 78, 104 and 130 post randomization|Included participants with available cytology results.|||Participants|||Count of Participants
1394423|NCT01315353|Secondary|Number of Participants Who Discontinued Study Early.|The number of participants who did not complete the study.|0 to 130 weeks post randomization|Intent to treat: All eligible participants were included in the analysis. Analysis was limited to the two randomized study arms (Arms A and B).|||Participants|||Count of Participants
1394424|NCT01315353|Secondary|Cumulative Rate of CIN3+ (CIN3 or Invasive Cancer) by Week 130.|"The Kaplan-Meier estimate of the cumulative rate of CIN3+ (CIN3 or invasive cancer) by week 130.~Time to CIN3+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN3+ was first detected. For those who did not develop CIN3+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. CIN3+ diagnosis by biopsy was determined by local review at a DAIDS-assessed laboratory."|Weeks 26, 52, 78, 104 and 130 post randomization|Intent-to-treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Analysis was limited to the two randomized study arms (Arms A and B).|||Cumulative rate of events/100 persons||95% Confidence Interval|Number
1394425|NCT01315353|Secondary|Time to CIN2+ Diagnosis by Biopsy, as Determined by Local Review at a DAIDS-assessed Laboratory.|Time to CIN2+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN2+ was first detected. For those who did not develop CIN2+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. The 10th percentile of the time to CIN2+ (the number of weeks at which 10% of participants had had CIN2+ diagnosis) is presented in the data table below.|Weeks 26, 52, 78, 104 and 130 post randomization|Intent to treat: All eligible participants were included in the analysis. Analysis was limited to the two randomized study arms (Arms A and B).|||weeks||95% Confidence Interval|Number
1394426|NCT01315353|Primary|Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130|"The Kaplan-Meier estimate of the cumulative rate of CIN2+ (CIN2, CIN3 or invasive cancer) by week 130.~Time to CIN2+ was computed as the number of weeks between randomization and the week 26 to week 130 biopsy week when CIN2+ was first detected. For those who did not develop CIN2+, event time was censored at the latest among the following: time of last biopsy or last colposcopy or last pap smear. CIN2+ diagnosis by biopsy was determined by local review at a DAIDS-assessed laboratory."|Weeks 26, 52, 78, 104 and 130 post randomization|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Analysis was limited to the two randomized study arms (Arms A and B).|||Events per 100 persons||95% Confidence Interval|Number
1394427|NCT01315249|Secondary|Number of Participants With Adverse Events|The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section.|26 weeks|Safety set includes all participants who received at least one dose of study drug.|||participants|||Number
1394428|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (26 Weeks)|After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|26 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.~flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."|||Liters||Standard Error|Least Squares Mean
1394429|NCT01315249|Secondary|Inspiratory Capacity (IC) at All-time Points (12 Weeks)|After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.|12 weeks|"Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits.~flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits."|||Liters||Standard Error|Least Squares Mean
1394430|NCT01315249|Secondary|Change From Baseline in Symptom Scores Reported Using the Ediary|"Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use.~Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked.~0 is the minimum score = “none” or “No symptoms” or “never” or “No”~= mild, a little~= moderate~= severe For the scale range provided, high values represent a worse outcome."|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||units on a scale||Standard Error|Least Squares Mean
1394431|NCT01315249|Secondary|Mean Change From Baseline in Daily Number of Puffs of Rescue Medication|Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.|Baseline, 12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||puffs||Standard Error|Least Squares Mean
1394432|NCT01315249|Secondary|Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)|The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||units on a scale||Standard Error|Least Squares Mean
1394433|NCT01315249|Secondary|Focal Score of the Transitional Dyspnea Index (TDI)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.|12 weeks and 26 weeks|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||units on a scale||Standard Error|Least Squares Mean
1394434|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 26)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1394435|NCT01315249|Secondary|Forced Vital Capacity at All-time Points (Week 12)|"Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.~This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model."|-45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1394436|NCT01315249|Secondary|Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours|Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1394437|NCT01315249|Primary|Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.|Week 26|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
1394438|NCT01315158|Secondary|Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups|The number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.|24-48 hours||||participants|||Number
1394439|NCT01315158|Secondary|Patient Tolerance as Assessed by Endoscopists|The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.|24-48 hours|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.||||||
1394440|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication||One year||||incidences|||Number
1394441|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline)||One year||||incidences|||Number
1394442|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)||One year||||incidences|||Number
1394443|NCT01315158|Secondary|Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)||One year||||participants|||Number
1394444|NCT01315158|Secondary|Compare Propofol Doses Between the Two Groups|The dose of propofol used between the two groups will be compared|One day (during procedure)|The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.||||||
1394446|NCT01315158|Primary|Number of Participants Who Experience Airway Maneuvers|In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.|One day (during procedure)||||participants|||Number
1394447|NCT01315145|Primary|Percentage of Participants With a 2-point Improvement in Visual Analogue Scale|The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.|16 weeks|All participants who reported 16 week outcomes are included in this analysis.|||percentage of responders|||Number
1394448|NCT01315028|Secondary|Global Assessment of Functioning (GAF)|Participant functioning was assessed using the Global Assessment of Functioning (GAF) (APA, 1987). The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living, with higher score indicating higher functioning. The score is often given as a range, from 1 - 10 Persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death, to 91 - 100 No symptoms. Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities.|monthly until October 2011||||units on a scale||Standard Deviation|Mean
1394449|NCT01315028|Secondary|The Internal State Scale (ISS) (Bauer et al, 1991)|"The Internal State Scale (ISS) (Bauer et al, 1991) is a 15 item self-report scale that utilizes 100 mm visual analogue scales to assess the presence and severity of symptoms, ranging from 'not at all / rarely' to 'very much so / much of the time' (score range per item 0 to 100). The ISS assesses depressive and hypomanic / manic symptoms across four factors: perceived conflict, activation, well-being and depression. Perceived Conflict is assessed across 5 items (score range 0 to 500), Activation across 5 items (score range 0 to 500), Well-being across 3 items (score range 0 to 300) and Depression across 2 items (score range 0 to 200).~The Well-being subscale is used in conjunction with the Activation subscale for mood state discrimination. The suggested scoring algorithm is as follows:~Mood State Activation Subscale Score Well-Being Subscale Score (Hypo)Mania >155 >125 Mixed State >155 <125 Euthymia <155 >125 Depression <155"|monthly until October 2011||||units on a scale||Standard Deviation|Mean
1394450|NCT01315028|Primary|Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979]|"The Bech-Rafaelsen Mania Rating Scale (BRMS) [Bech et al, 1979] provides a structured format for a clinician to assess the presence and severity of 11 core symptoms of hypomania or mania.Higher BRMS score indicates more severe symptoms of mania, and each item yields a score of 0 to 4. The overall score ranges from 0 to 44. Usual cutoff points are:~0 to 15 – normal /symptom absent 15 to 20 – mild 21 to 28 – moderate >34 – severe"|Baseline to End of Study||||units on a scale||Standard Deviation|Mean
1394451|NCT01315028|Primary|Montgomery Asberg Depression Rating Scale (MADRS) (Montogomery and Asberg, 1979)|"The Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) is a semi-structured interview designed to assess the presence and severity of 10 core symptoms of depression. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Usual cutoff points are:~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|Baseline to End of Study.||||units on a scale||Standard Deviation|Mean
1394452|NCT01315002|Primary|Error Percentage in Antisaccade Task|Three hours after the application of a nicotine or a placebo patch, performance on the antisaccade task is assessed. In the antisaccade task participants visually fixate a central stimulus which is replaced by a sudden onset target that appears at some distance to the left or right. Participants are told to refrain from looking at the peripheral target, and direct their gaze instead in the opposite direction (i.e. they have to make an antisaccade). Participants typically fail to achieve this on a significant number of trials and instead make reflexive glances towards the target (i.e. making a so-called antisaccade error). Error percentage in the antisaccade task is the unit of measure in this task. Error percentage in the antisaccade task = number of antisaccade errors / total number of trials.|Three hours after patch application||||Error Percentage in Antisaccade Task||Standard Deviation|Mean
1394453|NCT01314963|Primary|Relative Node Detection Sensitivity|Relative node detection sensitivity (S) was defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N). The outcome result is expressed as the percentage for each device with 95% confidence intervals.|1 day|Sentinel lymph nodes (SLNs) were evaluated for detection by the 2 methods.|||Percentage (%) of SLNs detected|Sentinel lymph nodes (SLNs)|95% Confidence Interval|Number
1394454|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Strong urge episodes||95% Confidence Interval|Least Squares Mean
1394464|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1394455|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Incontinence episodes||95% Confidence Interval|Least Squares Mean
1394456|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Number of Urge Incontinence Episodes at Week 52|Participants were required to keep a voiding diary, recording the occurrence of each urge incontinence episode. The average daily number of urge incontinence episodes was calculated as the total number of times a participant experienced such an episode during 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
1394457|NCT01314872|Secondary|Extension Study: Change From Baseline in Average Daily Micturitions at Week 52|Participants were required to keep a voiding diary, recording the daily occurrence of each micturition. The average daily number of micturitions was calculated as the total number of recorded micturitions that occurred during the 52-week Extension Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the value at Week 0 of the Base Study.|Baseline and Week 52 of Extension Study|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Micturitions||95% Confidence Interval|Least Squares Mean
1394458|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Strong Urge Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each strong urge episode. The average daily number of strong urge episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of strong urge episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Strong urge episodes||95% Confidence Interval|Least Squares Mean
1394459|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Average Daily Number of Total Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Incontinence episodes||95% Confidence Interval|Least Squares Mean
1394460|NCT01314872|Secondary|Base Study/Part 1: Change From Baseline in Number of Urge Incontinence Episodes at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each total incontinence episode. The average daily number of total incontinence episodes was calculated as the total number of times a participant experienced such an episode over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of total incontinence episodes that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint. This outcome measure included OAB Wet participants only.|||Urge incontinence episodes||95% Confidence Interval|Least Squares Mean
1394461|NCT01314872|Primary|Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 52 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1394462|NCT01314872|Primary|Extension Study: Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Extension: up to 54 weeks (including 2-week follow-up)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1394463|NCT01314872|Primary|Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Part 1: up to 8 weeks; Part 2: up to 4 weeks|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1394465|NCT01314872|Primary|Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8|Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.|Baseline and Week 8|Full analysis set population included all randomized participants who received at least one dose of study treatment and have either baseline data or at least one post-randomization observation for the analysis endpoint.|||Micturitions||95% Confidence Interval|Least Squares Mean
1394466|NCT01314742|Primary|Duration of Mechanical Ventilation|Time on invasive mechanical ventilation will be measured in days|3 days||||ventilator-days||Standard Deviation|Mean
1394467|NCT01314742|Primary|Feasibility|percentage of participants with retention|duration of study, for up to 30 months||||percentage of participants retained|||Number
1394468|NCT01314716|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.~Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough~Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set|||days||95% Confidence Interval|Median
1394469|NCT01314716|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.|||units on a scale||Standard Deviation|Mean
1394470|NCT01314716|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.|||units on a scale||Standard Deviation|Mean
1394471|NCT01314703|Primary|Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.|the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.|10 minutes after single application of test material|27 subjects were treated with ChloraPrep on the abdomen and groin treatment sites. 26 of the 27 abdomen sites met the qualifying bacterial baseline count and were included in the analysis. 25 of the groin sites met the qualifying bacterial baseline count and were included in the analysis.|||log 10 colony forming units||95% Confidence Interval|Mean
1394472|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Malondialdehyde at Day 7 From Day 0.|Plasma measurements of malondialdehyde, a marker of lipid peroxidation was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation|Day 0 and 7 of intervention||||microM||Standard Error|Mean
1394473|NCT01314443|Secondary|Absolute Change From Baseline in Plasma Gamma-tocopherol (Vitamin E) at Day 7 From Day 0.|Plasma measurements of gamma-tocopherol was assessed in response to smoking cessation and in combination with gamma-tocopherol (vitamin E) supplementation.|Day 0 and 7 of intervention||||microM||Standard Error|Mean
1394474|NCT01314443|Primary|Absolute Change in Brachial Artery Flow-mediated Dilation at Day 7 From Day 0|Flow-mediated dilation (FMD) of the brachial artery is measured to assess vascular endothelial function. FMD is obtained by monitoring change in vessel diameter before and after brachial artery occlusion with a blood pressure cuff. The unit of FMD is % and is calculated using the following equation: FMD = [(peak dilation at post occlusion - vessel diameter at preocclusion)/vessel diameter at preocclusion]*100.|Day 0 and 7 of intervention|Analysis was performed on all participants completing the 7 d intervention|||% of preocclusion diameter||Standard Error|Mean
1394475|NCT01314417|Secondary|Cytokine Analysis on Aqueous Samples to Assess Whether Intravitreal Injection of Methotrexate Affects Aqueous Inflammatory Cytokine Levels|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and Week 74|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
1394476|NCT01314417|Secondary|Observation of Dose Reduction of Systemic Immunosuppression or Steroids Over the Course of the Study Period|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and Week 74|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
1394477|NCT01314417|Secondary|Number of Participants Experiencing a Complete Resolution of Fluid as Seen on OCT at Any Time During the Study Period||Baseline and Week 74||||participants|||Number
1394478|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 24 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||participants|||Number
1394519|NCT01314118|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.|End of Cycle 3 (Approximately Month 3)|Efficacy evaluable set included all participants who received at least 1 dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.|||Percentage of Participants||95% Confidence Interval|Number
1394479|NCT01314417|Secondary|Number of Participants Presenting the Same Autofluorescence Patterns in the Study Eye as Seen on Fundus Autofluorescence (FAF) Imaging at Week 12 as Observed at Baseline|"Fundus autofluorescence patterns were assessed using fundus autofluorescence (FAF) imaging, a non-invasive technique that uses a confocal scanning ophthalmoscope to detect naturally-fluorescing lipofuscin.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||participants|||Number
1394480|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 24 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||participants|||Number
1394481|NCT01314417|Secondary|Number of Participants Presenting No Change in the Area of Leakage in the Study Eye as Seen on Fluorescein Angiography (FA) Imaging at Week 12 as Compared to Baseline|"Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA). Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||participants|||Number
1394482|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 20 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20||||ETDRS Letters|Eyes|Standard Deviation|Mean
1394483|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||ETDRS Letters||Standard Deviation|Mean
1394484|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 16 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16||||ETDRS Letters|Eyes|Standard Deviation|Mean
1394485|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||ETDRS Letters|Eyes|Standard Deviation|Mean
1394486|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 8 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8||||ETDRS Letters|Eyes|Standard Deviation|Mean
1394508|NCT01314261|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Full Range|Median
1394487|NCT01314417|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 4 Weeks Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4||||ETDRS Letters|Eyes|Standard Deviation|Mean
1394488|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 24 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||µm|Eyes|Standard Deviation|Mean
1394489|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 20 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20||||µm|Eyes|Standard Deviation|Mean
1394490|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 16 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16||||µm|Eyes|Standard Deviation|Mean
1394491|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 12 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||µm|Eyes|Standard Deviation|Mean
1394492|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 8 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8||||µm|Eyes|Standard Deviation|Mean
1394493|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Central Macular Thickness in the Study Eye at 4 Weeks Compared to Baseline|"Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4||||µm|Eyes|Standard Deviation|Mean
1394494|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 24 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 24||||percentage of change from baseline||Standard Deviation|Mean
1394495|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 20 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 20||||percentage of change from baseline||Standard Deviation|Mean
1394571|NCT01313780|Primary|Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)|Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment .|4weeks|Analysis of FAS: 117.|||units on a scale||Standard Deviation|Mean
1394496|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 16 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 16||||percentage of change from baseline||Standard Deviation|Mean
1394497|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 12 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 12||||percentage of change from baseline||Standard Deviation|Mean
1394498|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 8 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 8||||percentage of change from baseline||Standard Deviation|Mean
1394499|NCT01314417|Secondary|Change in Optical Coherence Tomography (OCT) Excess Retinal Thickening in the Study Eye at 4 Weeks Compared to Baseline|"Excess retinal thickening was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria."|Baseline and Week 4||||percentage of change from baseline||Standard Deviation|Mean
1394500|NCT01314417|Primary|Number of Participants Who Meet the Definition of Treatment Success Within 12 Weeks From Baseline.|"Treatment success is defined as achieving at least a 1-step decrease in the LogScore scale for central macular thickness.~A decrease of at least 1-step on the logOCT scale, where Change in logOCT=log(follow-up thickness/200) - log(baseline thickness/200) is considered clinically significant. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness and represents greater than twice the variability of retinal thickness measurements (approximately 25-30 µ).~Examples of OCT measurements with their corresponding LogScore, where LogScore=10xlogOCT are as follows:~LogScore 0 = OCT 200 µm, LogScore 1 = OCT 250 µm, LogScore 2 = OCT 320 µm, LogScore 3 = OCT 400 µm, LogScore 4 = OCT 500 µm, LogScore 5 = OCT 640 µm, LogScore 6 = OCT 800 µm, LogScore 7 = OCT 1000 µm"|12 weeks||||Participants|||Number
1394501|NCT01314313|Secondary|Effective Orifice Area (EOA)||2 years|Effective Orifice Area is listed for only the patients who had echo available at the follow-up visit.|||cm^2||Standard Deviation|Mean
1394502|NCT01314313|Secondary|NYHA Classification at 2 Years|New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.|2 years||||units on a scale||Standard Deviation|Mean
1394503|NCT01314313|Secondary|6MWT Change From Baseline|Six Minute Walk Test change from baseline to 2 years|Baseline and 2 years||||meters||Standard Deviation|Mean
1394504|NCT01314313|Secondary|Total Aortic Regurgitation (AR) at 2 Years|"Total aortic regurgitation was assessed by the core lab as Grade 0 = None, Grade 1+ = Trace, Grade 2+ = Mild, Grade 3+ = Moderate and Grade 4+ = Severe. Total regurgitation at one year was analyzed in the valve implant population."|2 years|All randomized patients who received the valve were analyzed. Note: Echos were not available for all the patients who made the follow-up visit.|||Grade||Standard Deviation|Mean
1394505|NCT01314313|Secondary|Adjusted Days Alive and Out of Hospital (DAOH) to Two Years|The number of days the patients are alive and out of the hospital.|2 years|Intent to Treat Population: All randomized patients with the exception of Total Aortic Regurgitation and Effective Orifice Area which was analyzed with the Valve Implant Population: All randomized patients receiving the valve.|||days||Standard Deviation|Mean
1394506|NCT01314313|Primary|All-cause Death or Disabling Stroke to Two Years|All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)|2 Years|Participants include all patients who were randomized.|||Participants|||Count of Participants
1394507|NCT01314261|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels < the lower level of quantification (< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.|Week 4 through Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
1394518|NCT01314261|Primary|Percentage of Participants With 4-week Rapid Virologic Response (RVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels < the lower limit of detection (< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.|Week 4|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.|||percentage of participants|||Number
1394509|NCT01314261|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).|At each study visit from Week 1 to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Full Range|Median
1394510|NCT01314261|Secondary|Median Time to Suppression of Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels < the lower limit of quantification (< 25 IU/mL). Data are reported as the median number of days.|Approximately 12 weeks|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||Days||95% Confidence Interval|Median
1394511|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.|24 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
1394512|NCT01314261|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-pegylated Interferon/Ribavirin (pegIFN/RBV) Dosing|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels < the lower limit of quantification (< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.|12 weeks after the last dose of pegIFN/RBV|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
1394513|NCT01314261|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA < the lower limit of quantification (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis.|||percentage of participants|||Number
1394514|NCT01314261|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng*hr/mL||Standard Deviation|Mean
1394515|NCT01314261|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||Hours||Standard Deviation|Mean
1394516|NCT01314261|Primary|Maximum Plasma Concentration (Cmax) of ABT-267|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
1394517|NCT01314261|Secondary|Percentage of Participants With Partial Early Virologic Response (pEVR)|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.|Baseline and Week 12|All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.|||percentage of participants|||Number
1396976|NCT01292005|Primary|Change in C-Reactive Protein (CRP)|C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.|baseline, Day 1, Day 3||||mg/L||Full Range|Median
1394520|NCT01314118|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
1394521|NCT01314118|Secondary|Time to Radiographic Evidence of Disease Progression (TTRP)|Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.|Maximum up to Month 30.5|All enrolled set included all participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
1394522|NCT01314118|Primary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study|Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.|End of core study visit (Approximately at Month 6)|Efficacy evaluable set included all participants who received at least one dose of study drug, completed at least 1 cycle of treatment and had at least 1 post-baseline PSA assessment.|||Percentage of participants||95% Confidence Interval|Number
1394523|NCT01314105|Secondary|Change From Baseline in Safety Laboratory Parameters|Change from baseline in safety laboratory parameters.|From the first drug administration until 28 days after the last drug administration, up to 31 months|Treated Set|||percentage of participants|||Number
1394524|NCT01314105|Secondary|Incidence and Intensity of Adverse Events|"Safety of nintedanib as indicated by intensity and incidence of adverse events, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.~The CTCAE grades are the worst grade per patient. The CTCAE grades are Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as lifethreatening or disabling AE, and Grade 5 as death related to AE."|From the first drug administration until 28 days after the last drug administration, up to 31 months|Treated Set|||participants|||Number
1394525|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of PLD (Determined as Plasma Doxorubicinol)|"The maximum measured plasma concentration (Cmax) of pegylated liposomal doxorubicin (PLD) (determined as plasma doxorubicinol).~Due to interference from doxorubicin, doxorubicinol concentrations could not be determined and doxorubicinol PK parameters could not be evaluated."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.||||||
1394526|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of PLD (Determined as Plasma Doxorubicinol)|"Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of pegylated liposomal doxorubicin (PLD) (determined as plasma doxorubicinol).~Due to interference from doxorubicin, doxorubicinol concentrations could not be determined and doxorubicinol PK parameters could not be evaluated."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.||||||
1394527|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of PLD (Determined as Plasma Doxorubicinol)|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) of pegylated liposomal doxorubicin (PLD) (determined as plasma doxorubicinol).~Due to interference from doxorubicin, doxorubicinol concentrations could not be determined and doxorubicinol PK parameters could not be evaluated."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.||||||
1394528|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of PLD (Determined as Total Plasma Doxorubicin) During Treatment Course 1 and Course 2|"The maximum measured plasma concentration (Cmax) of pegylated liposomal doxorubicin (PLD) (determined as total plasma doxorubicin) during treatment course 1 and course 2.~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 1 as for only 2 patients evaluable concentrations were available."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1394893|NCT01311661|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||mL||Standard Error|Mean
1394529|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of PLD (Determined as Total Plasma Doxorubicin) During Treatment Course 1 and Course 2|"Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of pegylated liposomal doxorubicin (PLD) (determined as total plasma doxorubicin) during treatment course 1 and course 2.~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 1 as for only 2 patients evaluable concentrations were available."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1394530|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of PLD (Determined as Total Plasma Doxorubicin) During Treatment Course 1 and Course 2|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) of pegylated liposomal doxorubicin (PLD) (determined as total plasma doxorubicin) during treatment course 1 and course 2.~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 1 as for only 2 patients evaluable concentrations were available."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1394531|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of Carboplatin During Course 1 and Course 2 (Determined as Ultrafilterable Platinum)|Maximum measured plasma concentration (Cmax) of carboplatin during course 1 and course 2 (determined as ultrafilterable platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1394532|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of Carboplatin (Total Platinum)|Maximum measured plasma concentration (Cmax) of carboplatin during course 1 and course 2 (determined as total platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1394533|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Ultrafilterable Platinum)|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of carboplatin during course 1 and course 2 (determined as ultrafilterable platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1394534|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Carboplatin (Determined as Total Platinum)|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of carboplatin during course 1 and course 2 (determined as total platinum).|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1394535|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC 0-inf) of Carboplatin During Treatment Course 1 and Course 2 (Determined as Ultrafilterable Platinum)|"Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity (AUC 0-inf) of carboplatin during treatment course 1 and course 2 (determined as ultrafilterable platinum).~Geometric mean (gMean) and Geometric coefficient of Variation (gCV) were not calculable for treatment course 2 as 2/3 of patients had quantifiable values."|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, and 34h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1394536|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carboplatin (Determined as Total Platinum)|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of carboplatin (determined as total platinum) during treatment course 1 and course 2.|5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 26h, 28h, 32h, 48h, 168h, 336h and 480h after drug administration|PK set.Goal is to find MTD for nintedanib,two doses of nintedanib separately displayed.However carboplatin,PLD are given as background,therefore only measured to know exposure.As result displaying all subjects is sufficient.Further we decided to make separate table for MTD dose(200mg nintedanib).Separate table for 150mg nintedanib doesnt add value.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1394537|NCT01314105|Secondary|Maximum Measured Plasma Concentration (Cmax) of Nintedanib|Maximum measured plasma concentration (Cmax) of nintedanib during course 1 and course 2|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1394538|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz) of Nintedanib|Area under the plasma concentration-time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz) of nintedanib during course 1 and course 2.|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1394539|NCT01314105|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Nintedanib|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of nintedanib during course 1 and course 2|5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration|Pharmacokinetic (PK) set: All patients in the treated set who were documented to have received at least one dose of nintedanib and who had at least one valid pharmacokinetic parameter concentration available|||nanogram*hour/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1394540|NCT01314105|Primary|Dose Limiting Toxicities During Treatment Course 1|"Number of patients with dose limiting toxicity (DLT) occurring during treatment course 1~The following AEs were to be reported as DLT events if their occurrence was considered to be drug-related:~Haematological toxicity:~Any CTCAE grade 4 haematological toxicity~CTCAE grade 4 neutropenia that was not associated with fever ≥38.5°C, if persisting for >7 days despite adequate supportive treatment~CTCAE grade ≥3 neutropenia of any duration if associated with fever ≥38.5°C~Any CTCAE grade 4 thrombocytopenia~CTCAE grade ≥3 thrombocytopenia if associated with bleeding of CTCAE grade ≥2~Non-haematological toxicity:~CTCAE grade ≥3 diarrhoea despite optimal medical management~CTCAE grade 2 diarrhoea persisting for more than 7 days despite optimal medical management~CTCAE grade ≥2 vomiting despite optimal medical management~ALT and/or AST elevation of CTCAE grade ≥3~ALT and/or AST elevation of >3x ULN in conjunction with bilirubin increase >2x ULN"|First 28-day treatment cycle|MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of carboplatin and PLD, started nintedanib (nin) and did not miss more than 13 doses of nin and/or took 1 dose of carboplatin and PLD, started nin and discontinued treatment due to a dose limiting toxicity during the MTD period|||participants|||Number
1394541|NCT01314105|Primary|Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1|Maximum Tolerated Dose (MTD) of nintedanib in combination with carboplatin and pegylated liposomal doxorubicin based on the occurrence of dose limiting toxicities (DLTs) during treatment course 1. MTD will be determined among the first 6 evaluable patients in each dose level. MTD is the highest dose at which the incidence of DLT is less than 2/6.|First 28-day treatment cycle|MTD set which included patients in the dose escalation part of the trial who started treatment course 2 and/or took 1 dose of carboplatin and PLD, started nintedanib (nin) and did not miss more than 13 doses of nin and/or took 1 dose of carboplatin and PLD, started nin and discontinued treatment due to a dose limiting toxicity during the MTD period|||mg|||Number
1394542|NCT01314014|Secondary|Median Time to Progression Free Survival in Participants With Relapsed/Refractory Indolent and Aggressive Lymphomas|Measured from start of treatment until disease progression or death from any cause.|up to 25 months|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.|||months||Full Range|Median
1394543|NCT01314014|Primary|Overall Response Rate of of Participants to Imexon in the Treatment of Relapsed/Refractory Indolent and Aggressive Lymphomas|CT, PET, or MRI scans for the assessment of objective tumor responses were performed at baseline, after cycle 2, and every 3 cycles thereafter until disease progression. Standard response criteria from the International Harmonization Project on Lymphoma were used for classification of objective tumor responses. Response was defined as PR (Regression of measuable disease and no new sites) if >= 50% decrease in sum of the product of the diameters of up to 6 largest dominant masses; no increase in size of other nodes (a) [18F]fluorodeoxyglucose (FDG)-avid or PET prior to therapy; one or more (PET) positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|One year|20 subjects were evaluable for response, 2 subjects discontinued therapy during cycle 1 due to progressive disease and grade 5 sepsis respectively.|||percentage of participants||95% Confidence Interval|Number
1394544|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 4|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 4|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
1394816|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Seizure Duration)|Mean duration in seconds of the seizure induced by ECT for each participant at each ECT administration they received.The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||seconds||Standard Deviation|Mean
1394545|NCT01314001|Secondary|Total Side-Effect Severity Index at Week 1|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Week 1|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
1394546|NCT01314001|Secondary|Total Side-Effect Severity Index at Target Quit Date|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Target Quit Date (Week 0)|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
1394547|NCT01314001|Secondary|Total Side-Effect Severity Index at Pre-Quit|"The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers).~Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects."|Pre-Quit (Week -1/Baseline)|Intent-to-treat population (all subjects who received at least one dose of intervention).|||units on a scale||Standard Deviation|Mean
1394548|NCT01314001|Secondary|7-day Point Prevalence Quit Rate at 6-month Follow up Survey|The percentage of ITT subjects who were verified as abstinent at the 6-month follow up survey. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 24|Intent-to-treat population (all subjects who received at least one dose of intervention).|||percentage of ITT subjects|||Number
1394549|NCT01314001|Primary|7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)|The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.|Week 11|Intent-to-treat population (all subjects who received at least one dose of intervention).|||percentage of ITT subjects|||Number
1394550|NCT01313936|Secondary|Changes in Standardized Uptake Values on FDG-PET Scans|To describe changes in standardized uptake values (SUVs) obtained by 18FDG-PET scan at study entry and in response to one cycle of protocol therapy.|One year|||||||
1394551|NCT01313936|Secondary|Changes in Diarrhea|To describe the rate of protocol associated diarrhea according to UGT1A1 genotype.|One year|||||||
1394552|NCT01313936|Secondary|Therapeutic Response Rate in Patients|To estimate the therapeutic response rate to this regimen according to the NANT modified-version of the International Neuroblastoma Response Criteria.|6 weeks||||Responses|||Number
1394553|NCT01313936|Primary|Number of Participants With Dose-limiting Toxicity as a Measure of Tolerability|To determine whether doses of 15 mCi/kg and 18 mCi/kg of 131I-MIBG are tolerable when given with irinotecan/vincristine on a 5-day schedule to children and young adults with high-risk refractory/relapsed neuroblastoma.|6 weeks||||participants with DLT|||Number
1394554|NCT01313923|Secondary|Statistical Measures|"The statistical goal is to observe success, an improvement in disease control while up-titrating sirolimus dosage. As there will be no control group, the subject or progress at the end of the study will be compared to their baseline at the beginning of the study. The subject and disease severity at the beginning of the study will be compared to the disease severity at each visit and be correlated with the dosage of sirolimus and corticosteroid. However, since no patient completed the study, the outcome and any data collected was not assessed."|Study early termination by investigator - no participant completed any visits of the study - no measurements taken|||||||
1394555|NCT01313923|Primary|Improvement of ABSIS Score While Reducing Steroid Dosage|"Measurement of disease severity will be quantified using ABSIS (Autoimmune Bullous Skin Disorder Intensity Score). Improvement in disease control is quantified by the maintenance or improvement of ABSIS score while reducing steroid dosage.~No results as study has been terminated early by the investigator."|Expected time line 24 months|This outcome was not assessed because no participant completed any visits of the study||||||
1394556|NCT01313910|Secondary|Duodenal Immune Reconstitution|changes in duodenal lamina propria CD3+/CD4+ density by immunohistochemistry|8 weeks||||CD3+/CD4+ per mm^2 lamina propria||Inter-Quartile Range|Median
1394557|NCT01313910|Secondary|Systemic Immune Activation|CD8+ T-cells with an activated phenotype (HLA-DR/CD38+ coexpression)|8 weeks||||% CD8/HLA-DR/CD38+||Inter-Quartile Range|Median
1394558|NCT01313910|Secondary|Measures of Gut Permeability|five-hour disaccharide absorption test|8 weeks||||percentage absorption||Inter-Quartile Range|Mean
1394559|NCT01313910|Secondary|Frequency of Pro-inflammatory Bacterial Orders|16S rDNA sequencing for Bacteroidetes/Firmicutes ratio|8 weeks||||ratio of Bacteroidetes/Firmicutes %||Inter-Quartile Range|Median
1394560|NCT01313910|Primary|Number of Bowel Movements Per Day|self-reported bowel movement in diary|8 weeks (56 days)||||bowel movements/day||Inter-Quartile Range|Median
1394572|NCT01313728|Secondary|Facial Tolerance|All interval measurements were combined for comparative assessment between treatment regimens. Facial tolerance is the sum of scores from Erythema, Dryness, Burning/Stinging, Itching, and Tightness assessments, reported in Outcome Measures 1-5. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 6250 (highest possible combined score of 25, times 10 days, times 25 subjects).|Baseline to 2 Weeks||||Scores on a Scale|||Number
1394561|NCT01313897|Primary|Therapeutic Efficacy|Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: >= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND >= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if >= 30% plasma cells at baseline); AND >=50% reduction in serum M protein and reduction in urine M protein >= 90% or to 200 mg/24hr OR >= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein < 1 g/dL, urine < 200 mg/24 hrs, and an involved serum free light chain level >= 10 mg/dL at baseline).|180 days||||Participants|||Count of Participants
1394562|NCT01313884|Secondary|Progression-free Survival (PFS)|The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.|24 months|All study participants were lost to follow-up after completion of active treatment and collection of response rate, ie, within 2 years of the treatment conclusion but before documented progression. No data.||||||
1394563|NCT01313884|Primary|Overall Response Rate (Partial and Complete Response)|"Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy.~Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters."|Up to 24 months||||Participants|||Count of Participants
1394564|NCT01313858|Primary|Number of Participants Who Experienced at Least One Serious Adverse Event|A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.|||Participants|||Number
1394565|NCT01313858|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 24 months|The safety population consists of all participants with at least one injection of Simponi®.|||Participants|||Number
1394566|NCT01313858|Primary|Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement."|Baseline and Months 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
1394567|NCT01313858|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.|Baseline and Months 3, 6, 12, 18, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
1394568|NCT01313858|Primary|Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score|The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH[%] = (Attained score*100)/(2*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.|Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
1394569|NCT01313858|Primary|Clinical Global Impression (CGI) Disease Status|"The CGI is a non-disease-specific evaluation of participants' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from 0 (free of complaints) to 10 (strong discomfort). The closer the score to 0, the better the health status."|Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24|The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.|||Units on a scale||Standard Deviation|Least Squares Mean
1394570|NCT01313780|Secondary|Change in Bowel Habits.|The change of bowel habits from baseline (Visit 1) in bowel habits at Week 4 was investigated, and was categorized as ‘improved’, ‘unchanged’, and ‘worsened’.|4 weeks|FAS analysis, but Oxycodone/naloxone group was missed 15 patients data and Oxycodone group was missed 23 patients data.|||participants|||Number
1394573|NCT01313728|Secondary|Subject Assessment – Tightness|Ordinal tightness scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
1394574|NCT01313728|Secondary|Subject Assessment – Itching|Ordinal itching scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
1394575|NCT01313728|Secondary|Subject Assessment – Burning/Stinging|Ordinal burning/stinging scores (on a scale of 0=none to 3=severe) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 750 (highest possible score of 3, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
1394576|NCT01313728|Primary|Expert Grader Assessment - Dryness|Ordinal dryness scores (on a scale of 0=none to 8=deep) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
1394577|NCT01313728|Primary|Expert Grader Assessment - Erythema|Ordinal erythema scores (on a scale of 0=none to 8=severe scaling and fissuring) were collected on weekdays for two weeks and the total daily score (for all subjects) was treated as a single interval measurement for comparative assessment between treatment regimens. Thus, for the total for the 25 Participants measured, minimum possible score reported below is 0 and maximum is 2000 (highest possible score of 8, times 10 days, times 25 subjects).|Baseline to 2 Weeks|Intention to Treat (ITT)|||Scores on a Scale|||Number
1394578|NCT01313689|Secondary|Mean Health Change Questionnaire (HCQ) Score|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for ‘my health is a great deal better’ to 9 for ‘my health is a great deal worse’ since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..|From the randomization date up to 60 months post the randomization date.|"Population Description:~Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation."|||Unit on a scale||Standard Deviation|Mean
1394579|NCT01313689|Secondary|Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) – and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.|||unit on a scale||Standard Deviation|Mean
1394580|NCT01313689|Secondary|Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.|From the randomization date up to 60 months post the randomization date.|Safety Population. Only those participants with post-OFA treatment HAHA results were analyzed.|||Participants|||Number
1394581|NCT01313689|Secondary|Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time|Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU), 36 Month Follow-up (36M FU), 42 Month Follow-up (42M FU). A cycle is defined as the time between one round of treatment until the start of the next round.|Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.|||Gram per liter||Standard Deviation|Mean
1394886|NCT01311661|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 3-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|3 weeks|FAS|||Units on a scale||Standard Error|Mean
1394582|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE) of Special Interest|AEs of special interest included cytopenias (neutropenia [decreased neutrophil count], anaemia [decreased hemoglobin], and thrombocytopenia [decreased platelet count]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.|||Participants|||Number
1394583|NCT01313689|Secondary|Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy|Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.|||Participants|||Number
1394584|NCT01313689|Secondary|Duration of Response as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.|||Months||95% Confidence Interval|Median
1394585|NCT01313689|Secondary|Time to Response as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (Complete Remission[CR], Complete Remission with incomplete bone marrow recovery[CRi], partial response[PR], or nodular PR[nPR]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.|From the randomization date up to 60 months post the randomization date.|ITT population. Only responders (CR, CRi, PR, nPR) were included in the analysis. Response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.|||Months||95% Confidence Interval|Median
1394586|NCT01313689|Secondary|Time to Next Anti-cancer Therapy by Investigator|Time to next therapy is defined as the time from randomization until the start of the next line of treatment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.|||Months||95% Confidence Interval|Median
1394587|NCT01313689|Secondary|Time to Progression as Assessed by IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed.|||Months||95% Confidence Interval|Median
1394588|NCT01313689|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.|From the randomization date up to 60 months post the randomization date.|ITT population. Only those participants with data available were analyzed, participants who had not died were censored at the date of last contact.|||Months||95% Confidence Interval|Median
1394589|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the Investigator|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.|||Participants|||Number
1394590|NCT01313689|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.|From the randomization date up to 60 months post the randomization date.|ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.|||Participants|||Number
1394591|NCT01313689|Secondary|Progression-free Survival (PFS) as Assessed by Investigator|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.|||Months||95% Confidence Interval|Median
1394592|NCT01313689|Primary|Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)|PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.|From the randomization date up to 60 months post the randomization date.|Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.|||Months||95% Confidence Interval|Median
1394593|NCT01313676|Secondary|Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date|On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.|From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)|ITT-E Population|||Participants|||Number
1394594|NCT01313676|Secondary|Decline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.|From start date of IP until IP stop date + 1 (assessed up to 4 years)|ITT-E Population|||milliliter/year||Standard Error|Least Squares Mean
1394595|NCT01313676|Primary|Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date|Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.|From the date of randomization until date of death due to any cause (average of 2 study years)|ITT-E Population|||Participants|||Number
1394596|NCT01313663|Secondary|Number of Participants With the Indicated Changes From Baseline Value in Lactate Dehydrogenase (LDH)|"Change from Baseline in the laboratory parameter LDH was assessed as decrease to low, change to normal of no change, and increase to high. Participants with missing Baseline values were assumed to have a normal Baseline value. There is no standard normal range for LDH."|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
1394887|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS|||Number of patients|||Number
1394597|NCT01313663|Secondary|Number of Participants With the Indicated Grade Changes From Baseline Grade in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk. Phos.), and Total Bilirubin (TB)|The laboratory parameters AST, ALT, Alk. Phos., and TB were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for any grade increase, increase to Grade 3, and increase to Grade 4. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. AST/ALT: Grade 1, >upper limit of normal (ULN) - 3.0x ULN; Grade 2, >3.0 to 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, not available (NA). Alk. Phos.: Grade 1, >ULN - 2.5x ULN; Grade 2, >2.5 - 5.0x ULN; Grade 3, >5.0 - 20.0x ULN; Grade 4, >20.0x ULN; Grade 5, NA. TB: Grade 1, >ULN - >1.5x ULN; Grade 2, >1.5 - 3.0x ULN; Grade 3, >3.0 - 10.0x ULN; Grade 4, >10.0x ULN; Grade 5, NA.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
1394598|NCT01313663|Secondary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Laboratory Parameters|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Lymphocyte count increased: Grade 3, <500 - 200/millimeters cubed (mm^3); <0.5 - 0.2x 10e9/Liters (L); Grade 4, <200/mm^3; <0.2x 10e9/L. Lymphocyte count decreased: Grade 3, >20000/mm^3; Grade 4, NA. Hyperglycemia; Grade 3, >250 - 500 milligrams per deciliter (mg/dL); >13.9 - 27.8 millimoles per Liter (mmol/L); hospitalization indicated; Grade 4, >500 mg/dL; >27.8 mmol/L; life-threatening consequences. Hypophosphatemia (inorganic phosphorus): Grade 3, <2.0 - 1.0 mg/dL, <0.6 - 0.3 mmol/L; Grade 4, <1.0 mg/dL, <0.3 mmol/L, life-threatening consequences.|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
1394599|NCT01313663|Secondary|Number of Participants With a Increase From Baseline in Bazett's QTc at the Indicated Time Points|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In clinical studies with pazopanib, events of QT prolongation have occurred.|Baseline; Week 6; Week 15; every 9 weeks in the first 6 months; every 12 weeks in the next 6 months; and, after 1 year, every 6 months (up to Study Week 55)|Safety Population|||participants|||Number
1394600|NCT01313663|Secondary|Number of Participants With the Indicated Worst-case Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure (BP) were measured. Categories correspond to the following Common Terminology Criteria for Adverse Events (CTCAE) grades: normal, <120/80 millimeters of mercury (mmHg); prehypertension, 120–139/80–89 mmHg, warranting intervention in participants with high risk; stage I hypertension, 140–159/90–99 mmHg, warranting intervention; and stage II hypertension >/=160/100, warranting immediate attentive intervention to prevent acute symptoms. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Participants with a missing Baseline value were assumed to have a Baseline value of <120 for systolic BP (SBP) and <80 for diastolic BP (DBP).|From the time of the first dose of study treatment until 28 days following discontinuation of study treatment (up to Study Week 55)|Safety Population|||participants|||Number
1394601|NCT01313663|Secondary|Number of Participants With Any On-therapy AE (Serious or Non-serious) Leading to Dose Reductions (DRs) or Interruptions/Delays in the Study|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Management of AEs may require DRs/interruptions in study treatment. If necessary, the pazopanib dose should be reduced stepwise by 200 mg at each step. DRs for pemetrexed were 50-75% of prior dose based on the toxicity leading to DR.|From the time the first dose of study treatment was administered until discontinuation of treatment (up to Study Week 55)|Safety Population|||participants|||Number
1394602|NCT01313663|Secondary|Number of Participants With Any AE (Serious or Non-serious) Leading to Withdrawal From Study Treatment|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. A participant cold have been withdrawn fom study treatment due to an SAE or AE.|From the time the first dose of study treatment was administered until withdrawal from study treatment (up to Study Week 55)|Safety Population|||participants|||Number
1394603|NCT01313663|Secondary|Average Dose of Pemetrexed for All Cycles, as a Measure of Extent of Exposure|"The average dose of pemetrexed for all cycles, as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The average dose was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population|||milligrams per meters squared (m^2)||Standard Deviation|Mean
1394888|NCT01311661|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment .|0-3 weeks|FAS|||Number of patients|||Number
1394931|NCT01311362|Primary|AUC of Ambrisentan||after first dose, at steady-state, during St John's wort||||h*ng/ml||95% Confidence Interval|Geometric Mean
1394604|NCT01313663|Secondary|Mean Number of Pemetrexed Dosing Cycles, as a Measure of Extent of Exposure|"Duration of therapy/time on study treatment, measured as the mean number of pemetrexed dosing cycles as a measure of extent of exposure, was assessed in all participants who received pemetrexed. The mean number of dosing cycles was not measured in participants receiving pazopanib. For these participants, extent of exposure was measured as the time on study treatment and mean daily dose. See the outcome measures entitled Time on study treatment (pazopanib), as a measure of extent of exposure and Mean daily dose, as a measure of extent of exposure, respectively, for pazopanib data."|From the time the first dose of study treatment was administered until discontinuation of the study or death (average of 16 weeks)|Safety Population|||number of cycles||Standard Deviation|Mean
1394605|NCT01313663|Secondary|Mean Daily Dose, as a Measure of Extent of Exposure|"Mean daily dose, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Mean daily dose was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population|||milligrams||Standard Deviation|Mean
1394606|NCT01313663|Secondary|Time on Study Treatment (Pazopanib), as a Measure of Extent of Exposure|"Time on study treatment, as a measure of extent of exposure, was assessed in all participants who received pazopanib. Time on study treatment was not measured in participants receiving pemetrexed. For these participants, extent of exposure was measured as the mean number of dosing cycles and dose intensity. See the outcome measures entitled Mean number of dosing cycles, as a measure of extent of exposure and Average dose of pemetrexed for all cycles, as a measure of extent of exposure, respectively, for pemetrexed data."|From the first day to the last day of treatment (average of 8 weeks)|Safety Population|||months||Standard Deviation|Mean
1394607|NCT01313663|Secondary|Number of Participants With Any Non-serious On-therapy Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. In addition, all Grade 4 laboratory abnormalities and other medically important events that require medical or surgical intervention to prevent one of the outcomes listed previously are considered to be SAEs. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the time the first dose of study treatment was administered until 28 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (up to Study Week 55)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.|||participants|||Number
1394608|NCT01313663|Secondary|Number of Participants (Par.) With the Indicated Best Overall Response|A par. was defined as a responder if s/he sustained a CR (The disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters) that was confirmed after >=28 days. Response was evaluated by an investigator per RECIST, version 1.1. A par. without a post-Baseline assessment was considered a non-responder. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started). To qualify as a best response of SD, a response of SD had to be observed >=12 weeks after randomization. A par. who was not evaluable had no scans at all or did not have a confirmatory scan.|From randomization until the time of the first documented evidence of a confirmed complete response (CR) or partial response (PR) (average of 10 weeks)|ITT Population|||participants|||Number
1394609|NCT01313663|Secondary|Overall Survival|Overall survival is defined as the interval between the date of randomization and the date of death from any cause.|From randomization until disease progression or death (up to Study Week 78)|The study size (20 participants) and follow up were not adequate to assess overall survival. Participants who had not died at the time of the cut-off for the analysis were to be censored at the date the particpant was last known to be alive.||||||
1394610|NCT01313663|Primary|Progression Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the first documented sign of investigator-assessed (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) disease progression (PD) or death, whichever occurs first. The date of documented PD is the date of lesion evaluation in the case of radiological PD and the date of symptomatic cancer progression in the case of symptomatic progression (radiological confirmation is required). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was to be censored at the last adequate assessment (LAA) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of progression or death, PFS was to be censored at the date of the LAA.|From randomization until the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered|||weeks||90% Confidence Interval|Median
1394647|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percent FEV1/FVC||Full Range|Median
1394611|NCT01313650|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1394612|NCT01313650|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394613|NCT01313650|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1394614|NCT01313650|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394615|NCT01313637|Other Pre-specified|Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24|The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day’s activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1394648|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percent FEV1/FVC||Full Range|Median
1394616|NCT01313637|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 168|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394617|NCT01313637|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1394618|NCT01313637|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1394619|NCT01313624|Secondary|Time to Protocol-Defined Exacerbation (PDE)|"Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.~Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough~Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis"|Baseline to Day 112|ITT Analysis Set|||days||95% Confidence Interval|Median
1394620|NCT01313624|Secondary|Change in QOL-B Respiratory Symptoms Score at Day 84|The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 84|Participants in the ITT Analysis Set with scores at both baseline and Day 84 were analyzed.|||units on a scale||Standard Deviation|Mean
1394621|NCT01313624|Primary|Change in QOL-B Respiratory Symptoms Score at Day 28|The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.|Baseline to Day 28|Participants in the ITT Analysis Set with scores at both baseline and Day 28 were analyzed.|||units on a scale||Standard Deviation|Mean
1394622|NCT01313559|Secondary|Number of Participants With Progression Free Survival (PFS) Based on RECIST 1.1 Criteria|Progression free survival (PFS) based on primary outcome criteria for disease progression. Patients without radiographic disease progression who permanently discontinue the study drugs will be censored|Assessed up to 30 days after completion of study treatment||||participants|||Number
1394623|NCT01313559|Secondary|Number of Participants Without New Bone Lesions After 12 Weeks of Treatment||After 12 weeks of treatment||||participants|||Number
1394624|NCT01313559|Secondary|Number of Participants With > 50% Decline From Baseline PSA Level||After 12 weeks of treatment||||participants|||Number
1394625|NCT01313559|Primary|Number of Participants Alive and Progression Free After 12 Weeks of Treatment|Progression of disease is defined as disease progression by RECIST 1.1 criteria on CT scan (X-ray computed tomography), or appearance of > 2 new bone lesions on bone scan, or prostate-specific antigen (PSA) progression by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria or death from any cause.|12 weeks after treatment||||participants|||Number
1394813|NCT01312909|Secondary|Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52|The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.|Weeks 12, 24 and 52|The full analysis set included all randomized participants.|||percentage of participants|||Number
1394626|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Rheumatoid Arthritis MRI Score (RAMRIS) Synovitis + RAMRIS Osteitis.|"DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of CRP. RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations, ranging from 0 to 24 total. RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations, ranging from 0 to 75 total. The individual~endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic."|Baseline and Week 14|Participants treated with Infliximab or placebo|||Z-score||95% Confidence Interval|Least Squares Mean
1394627|NCT01313520|Secondary|Change From Baseline in Standardized Z-scores of Composite Endpoint Consisting of Clinical Disease Activity Measure DAS28 CRP + Ktrans.|Clinical disease activity score (DAS28 CRP) is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), Patient Global Assessment of Disease Status (GADP) on a 100 mm visual analog scale (VAS) and concentration of CRP. Ktrans is the volume transfer rate from the blood plasma to the enhancing synovium. The individual endpoints are standardized using z-scores, then the z-scores are averaged to create a composite endpoint by use of O'Brien's global statistic.|Baseline and Week 14|Participants treated with Infliximab or placebo|||Z-score||95% Confidence Interval|Least Squares Mean
1394628|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Osteitis.|RAMRIS Osteitis is an ordinal scoring system of hand osteitis that is scored from 0 to 3 in 25 locations. The scores can range from 0 to 75, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo. One participant in the placebo group missing a baseline value was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1394629|NCT01313520|Other Pre-specified|Change From Baseline in RAMRIS Synovitis.|RAMRIS Synovitis is an ordinal scoring system of hand synovitis that is scored from 0 to 3 in 8 locations. The scores can range from 0 to 24, with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo|||units on a scale||Standard Deviation|Mean
1394630|NCT01313520|Other Pre-specified|Change From Baseline in DAS28 CRP.|DAS28 CRP is a composite index of the following: number of tender joints (28 joint count), number of swollen joints (28 joint count), GADP on a 100 mm VAS and concentration of serum CRP. Scores can range from 2-10; with higher values corresponding to higher disease activity, and lower values to better outcomes.|Baseline and Week 14|Participants treated with infliximab or placebo|||units on a scale||95% Confidence Interval|Least Squares Mean
1394631|NCT01313520|Secondary|Percentage of Responders With a 50% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR50).|ACR50 requires that both tender and swollen joint counts improve by at least 50% from baseline, as well as a 50% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and CRP.|Baseline and week 14|Participants treated with Infliximab or placebo|||percentage of responders||90% Confidence Interval|Number
1394632|NCT01313520|Secondary|Percentage of Responders With a 20% Improvement From Baseline in American College of Rheumatology (ACR) Responder Criteria for Tender and Swollen Joints (ACR20).|ACR20 requires that both tender and swollen joint counts improve by at least 20% from baseline, as well as a 20% improvement in at least 3 other core measures from the following: pain, patient's and physician's global assessment, physical disability and C-reactive protein (CRP).|Baseline and week 14|Participants treated with Infliximab or Placebo|||percentage of responders||90% Confidence Interval|Number
1394633|NCT01313520|Primary|Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans)|Dynamic Contrast Enhanced (DCE) Magnetic Resonance Imaging (MRI) was performed on one hand at baseline, and then at treatment week 14 to measure the rate constant of transfer of contrast (Ktrans).|Baseline and week 14|Participants treated with infliximab or placebo|||min ^-1||95% Confidence Interval|Least Squares Mean
1394634|NCT01313507|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug|An adverse event was considered to be temporally related to the study drug if it started during an infusion or within 72 hours after the end of an infusion.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.|||Percentage of participants|||Number
1394635|NCT01313507|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug|An adverse event was considered to be causally related to the administration of the study drug if it judged to be probably or possibly related to the study drug, as assessed by the investigator.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.|||Percentage of participants|||Number
1394636|NCT01313507|Secondary|Change From Baseline in the Quality of Life (QoL) at the End of the Study|QoL was assessed with the Child Health Questionnaire-Parent Form (CHQ-PF50), completed by a parent or guardian, in participants < 14 years of age at the start of the previous study NGAM-01 and with the Short Form-36 Health Survey (SF-36-HS) in participants ≥ 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated scores were transformed so that each scale had a range of 0-100. A higher score indicates better health. The SF-36-HS is composed of 36 items. Responses to the 36 items were combined to create 8 scales. The 8 scales could be further combined into 2 scores: Physical component summary and mental component summary. The item and scale scores were transformed to a range of 0-100 with a mean of 50 and a standard deviation of 10 in the general US population. A higher score indicates better health. For both instruments, a positive change indicates improvement.|Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)|Safety analysis set: All participants who received at least 1 dose of NewGam.|||Units on a scale||Standard Deviation|Mean
1394889|NCT01311661|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM3 device during each period of randomised treatment.|0-3 weeks|FAS|||Number of patients|||Number
1394637|NCT01313494|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above. Each AE was assessed by the Investigator as either 'related' or 'not related' to study drug.|24 weeks|Safety population, all randomized patients who took at least 1 dose of the trial treatment after randomization.|||participants|||Number
1394638|NCT01313494|Secondary|Time to Onset of Second Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation – date of first intake of study drug + 1 day. At least 10 days between the stop date of an exacerbation and the start date of the following exacerbation was required for these to be be considered as two separate COPD exacerbations. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population who experienced a second moderate to severe COPD exacerbation.|||days||Full Range|Median
1394639|NCT01313494|Secondary|Time to Onset of First Moderate or Severe COPD Exacerbation|Time to onset of a COPD exacerbation is defined as onset date of COPD exacerbation – date of first intake of study drug + 1 day. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat population with at least one moderate or severe exacerbation|||days||Full Range|Median
1394640|NCT01313494|Secondary|Mean Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|The mean rate of COPD exacerbations per patient per year rate = (number of exacerbations per treatment group/time to study withdrawal per treatment group) * 365. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat|||exacerbations per patient per year|||Number
1394641|NCT01313494|Secondary|Percentage of Participants With Moderate or Severe COPD Exacerbations|A COPD exacerbation is an event characterised by a worsening in the patient’s baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue. COPD exacerbations were categorized as follows: - Severe: Requiring hospitalization and/or leading to death; - Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|24 weeks|Intent-to-treat|||percentage of participants|||Number
1394642|NCT01313494|Secondary|Transition Dyspnoea Index (TDI) Total Score at Week 24|"The TDI is a recognized questionnaire to measure dyspnoea (shortness of breath) in patients with COPD. Questions from the TDI were used to assess the 3 components: change in functional impairment, change in magnitude of task and change in magnitude of effort. Transitions or changes from baseline are rated from -3 (major deterioration) to +3 (major improvement), and summed to give a total score ranging from -9 to +9. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables."|Baseline to Week 24|Intent-to-treat population with available data.|||units on a scale||Standard Error|Least Squares Mean
1394643|NCT01313494|Secondary|Change From Baseline in Use of Rescue Medication|Salbutamol (given by metered dose inhaler and spacer) was used as rescue medication according to the individual needs of a patient. Each use was documented in the patient’s paper diary. Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||puffs/day||Standard Error|Least Squares Mean
1394644|NCT01313494|Secondary|Change From Baseline in COPD Symptom Scores|Symptoms of chronic bronchitis with respect to cough and sputum production were assessed daily by the patient and recorded in a diary. Symptoms were assessed on a 4-point scale as follows: Cough: 0: no cough; 1: mild cough (at some time during the day); 2: moderate cough (regularly during the day); 3: severe cough (never free of cough or feeling free of need to cough). Sputum production: 0: no sputum production (unnoticeable); 1: mild sputum production (noticeable as a problem); 2: moderate sputum production (frequent inconvenience); 3: severe sputum production (constant problem). Change from Baseline is reported for cough and sputum separately, and for the sum of the 2 scores (range 0 - 6). Least squares means (LSM) are from a repeated measures ANCOVA model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||units on a scale||Standard Error|Least Squares Mean
1394645|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percentage of FEV1/FEV6||Full Range|Mean
1394646|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Ratio of Forced Expiratory Volume After 1 Second to Forced Expiratory Volume After 6 Seconds|The FEV1/FEV6 ratio represents the percentage of the volume of air expired in the first six seconds that is expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication.|Baseline and Week 24|Intent-to-treat population with available data; last observation carried forward (LOCF) was used.|||percentage of FEV1/FEV6||Full Range|Median
1394698|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Red Blood Cell (RBC) Count|Blood samples for RBC count were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Tera cells/Litre (L)||Full Range|Mean
1394649|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/minute||Standard Error|Least Squares Mean
1394650|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Peak Expiratory Flow Rate (PEF)|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/minute||Standard Error|Least Squares Mean
1394651|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
1394652|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Six Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV6, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
1394653|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
1394654|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Three Seconds (FEV3)|FEV3 is the amount of air which can be forcibly exhaled from the lungs in the first three seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV3, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
1394655|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/second||Standard Error|Least Squares Mean
1394656|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Flow 25-75%|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters/second||Standard Error|Least Squares Mean
1394657|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
1394658|NCT01313494|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC)|Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
1397043|NCT01290822|Secondary|Interventricular Synchrony||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
1394659|NCT01313494|Secondary|Change From Baseline in Post-bronchodilator FEV1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Post-bronchodilator measurements were taken 30 minutes after four inhalations of 100 μg salbutamol. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of post-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population with available data.|||liters||Standard Error|Least Squares Mean
1394660|NCT01313494|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry prior to taking study medication. Change from baseline over 24 weeks of treatment was calculated from a repeated measures analysis of covariance (ANCOVA) model with treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction as independent variables.|Baseline to Week 24|Intent-to-treat population included all randomly assigned patients who took at least 1 dose of trial treatment after randomization. Patients were assigned to the treatment group based on the treatment to which they were randomly assigned. Only patients with available data at Baseline and with at least 1 post-baseline measurement are included.|||liters||Standard Error|Least Squares Mean
1394661|NCT01313312|Secondary|Mean Change From Baseline in European 5 Dimensions, 5 Level (EQ-5D-5L) QoL at End of Study/Early Withdrawal Visit|Subjects were asked to complete the EQ-5D-5L QoL questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/depression and scored their general health state. Each dimension has 5 levels of severity (no problems, slight problems,moderate problems, severe problems and extreme problems). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean values for each dimension and the VAS scores at baseline and at the end of-study /early withdrawal are reported.|Up to Week 52|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394662|NCT01313312|Secondary|Mean Change From Baseline in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) at End of Study/Early Withdrawal Visit|Subjects were asked to complete the SF-36 questionnaires prior to the study treatment at baseline and at the end of study/early withdrawal visit. The SF-36 is a generic non-preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0–100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. Baseline results and the change from baseline to end of study/early withdrawal for the PCS and MCS are reported.|Up to Week 52|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394663|NCT01313312|Secondary|Mean Change From Baseline in Modified Frenchay Scale (MFS) at Week 4|The MFS was used to measure upper limb active function. Each subject was video taped while performing specific tasks. The videos were sent to a central provider and were read and scored by two independent readers blinded to the timing of the video and to treatment. These central assessments were used for the analysis of efficacy endpoints. The MFS consists of 10 tasks asking the subject to reach, grasp, carry and release different objects of different sizes which subjects are likely to use in their daily life. Each of these tasks was rated on a 10 point scale ranging from no movement to normal movement; for each task, the score 5 is used to rate a task barely accomplished. Mean change in MFS from baseline to Week 4 was reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394664|NCT01313312|Secondary|Mean Change From Baseline at Week 4 in Ease of Applying a Splint|The ease of applying a splint was evaluated on a 6-point scale (0= no splint needed, –1= splint needed and applied with no difficulty, –2= splint needed and applied with mild difficulty, –3= splint needed and applied with moderate difficulty, –4= splint needed and applied with severe difficulty, –5= splint needed,but unable to apply). Mean change in ease of applying a splint from baseline to Week 4 was reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394665|NCT01313312|Secondary|Mean Change From Baseline in Active Range of Motion (AROM) at Week 4 in the 3 Possible PTMGs|The AROM was assessed by the range of extension achieved by the subject moving each joint in the PTMGs (extrinsic finger flexors, elbow flexors and wrist flexors) without assistance. A goniometer was used for measurements in the elbow and wrist flexors but not for measurements in the extrinsic finger flexors. Mean changes in AROM in the 3 possible PTMGs from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1397044|NCT01290822|Secondary|Peak RV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
1394666|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Shoulder Extensors|The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394667|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Shoulder Extensors|The TS was used to measure spasticity in shoulder extensors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
1394668|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Wrist Flexors as PTMG|The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394669|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Wrist Flexors as PTMG|The TS was used to measure spasticity in wrist flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
1394670|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Elbow Flexors as PTMG|The TS was used to measure spasticity in elbow flexors.The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394671|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Elbow Flexors as PTMG|The TS was used to measure spasticity in elbow flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
1397045|NCT01290822|Secondary|Peak LV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
1394672|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Spasticity Grade (Y) in Extrinsic Finger Flexors as PTMG|The TS was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394673|NCT01313312|Secondary|Mean Change From Baseline to Week 4 for Angle of Arrest (XV1), Angle of Catch (XV3) and Angle of Spasticity (X) in Extrinsic Finger Flexors as PTMG|The Tardieu Scale (TS) was used to measure spasticity in extrinsic finger flexors. The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Degrees||Standard Deviation|Mean
1394674|NCT01313312|Secondary|Percentage of Subjects With at Least One Grade Reduction in DAS for Individual Domains at Week 4|The DAS is a 4-point scale. The extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least one grade reduction in DAS for each of the individual domains at Week 4 is reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
1394675|NCT01313312|Secondary|Percentage of Subjects With at Least 1 Grade Reduction in DAS for PTT at Week 4|At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The percentage of subjects with at least 1 grade reduction from baseline in DAS for PTT at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||Percentage of Subjects|||Number
1394676|NCT01313312|Secondary|Mean Change From Baseline in Disability Assessment Scale (DAS) Score for the Principal Target of Treatment (PTT) at Week 4|At baseline the subject and investigator together selected one of the four DAS domains as the PTT. The selected domain was required to have a rating of moderate or severe (≥2) at baseline. The DAS is a 4-point scale, the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain) was rated as follows: 0=no disability, 1=mild disability (noticeable but does not interfere significantly with normal activities), 2=moderate disability (normal activities require increased effort and/or assistance) and 3=severe disability (normal activities limited). The mean changes in DAS at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394677|NCT01313312|Secondary|Physician's Global Assessment (PGA) of Treatment Response at Week 4|The PGA is a 9-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. An assessment of overall treatment response was conducted by the investigator and the mean PGA scores during long-term open label treatment with Dysport were reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394678|NCT01313312|Secondary|Mean Change From Baseline MAS in the Shoulder Extensors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the shoulder extensors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394679|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Elbow Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the elbow flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
1394680|NCT01313312|Secondary|Mean Change From Baseline MAS in the Elbow Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the elbow flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394681|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Wrist Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction in mean MAS in the wrist flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
1394682|NCT01313312|Secondary|Mean Change From Baseline MAS in the Wrist Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the wrist flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394683|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Extrinsic Finger Flexors at Week 4|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the extrinsic finger flexors at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of subjects|||Number
1394684|NCT01313312|Secondary|Mean Change From Baseline MAS in the Extrinsic Finger Flexors at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the extrinsic finger flexors are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394685|NCT01313312|Secondary|Percentage of Subjects With at Least 1 or 2 Grade Reduction in MAS for Overall PTMG|The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The percentage of subjects with at least a 1 grade reduction and at least a 2 grades reduction from baseline in mean MAS in the overall PTMG at Week 4 are reported.|At Week 4|The ITT population was defined as all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||percentage of participants|||Number
1394686|NCT01313312|Secondary|Mean Change From Baseline Modified Ashworth Scale (MAS) in the Overall Primary Targeted Muscle Group (PTMG) for Upper Limb at Week 4|The clinical assessment of muscle tone was performed using the MAS. The MAS consists of 6 grades: 0, 1, 1+, 2, 3, or 4 that can be applied to muscles of both the upper and lower limbs. The MAS was applied by the rater by stretching the joint through its full available range over 1 second. The mean changes from baseline to Week 4 in MAS in the overall PTMG (finger, wrist or elbow flexors) are reported.|At Week 4|The Intent-to-Treat (ITT) population was all enrolled subjects who received at least one injection of study medication in this open label extension study. Too few subjects were treated in Cycle 5 to allow direct comparisons with other cycles and are not reported. Only subjects with data available for analysis at the point of testing are reported.|||units on a scale||Standard Deviation|Mean
1394752|NCT01313208|Secondary|C-reactive Protein Levels at Each Time Point|C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||mg/L||Standard Deviation|Mean
1394687|NCT01313312|Primary|Number of Subjects With Botulinum Toxin A Binding and Neutralising Putative Antibodies|Blood samples were collected at baseline, Week 4 of each cycle, and at the end of study/early withdrawal to test for the presence of Botulinum Toxin A Binding antibodies. Samples positive for the presence of binding antibodies were then analysed for the presence of neutralising putative antibodies. The number of subjects who were either positive (+ve) or negative (-ve) at baseline and then positive post baseline for binding or neutralising antibodies were reported.|Up to Week 52|Binding and neutralising antibodies were evaluated at baseline for all 258 subjects (rollover and de novo) enrolled in Study 148. Only subjects with data available for analysis at the point of testing are reported.|||Participants|||Number
1394688|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in 12 Lead ECG - HR|HR was measured by 12-lead ECG tracing, performed at baseline, at post treatment follow up visit Week 4, and at the end of study or early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest.|Up to Week 52|The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.|||bpm||Standard Deviation|Mean
1394689|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose|Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||millimoles(mmol)/L||Full Range|Mean
1394690|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Total Bilirubin and Creatinine|Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Micromole/L (μmol/L)||Full Range|Mean
1394691|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)|Blood samples for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||International Unit/L (IU/L)||Full Range|Mean
1394692|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in 12-Lead Electrocardiogram (ECG)|12-lead ECG tracing was performed at baseline, post treatment at Week 4 and at the end of study/early withdrawal visit. The 12-lead ECG recordings were performed at a paper speed of 25 mm/s, recorded with the subject in a supine position after 5 minutes rest. The ECG parameters reported were QRS duration, PR duration, QT duration, QTcB (QT interval corrected for HR according to Bazett), and QTcF (QT interval corrected for HR according to Fridericia) at baseline and the change to end of study/early withdrawal visit (EOS).|Up to Week 52|The ECG analysis was performed in the safety population among subjects who had at least one ECG measurement before injection and at least one ECG after injection. Only subjects with data available for analysis at the point of testing are reported.|||milliseconds (ms)||Standard Deviation|Mean
1394693|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets|Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at post treatment follow up visit Week 4, and at end of study or early withdrawal.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Giga cells/L||Full Range|Mean
1394694|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Volume (MCV)|Blood samples for MCV were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||femtoliters (fL)||Full Range|Mean
1394695|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Mean Corpuscular Haemoglobin (MCH)|Blood samples for MCH were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||picograms (pg)||Full Range|Mean
1394696|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Haematocrit|Blood samples for haematocrit were taken at baseline, at post treatment follow up visit Week 4, and at end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||percentage of RBC in blood||Full Range|Mean
1394697|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)|Blood samples for haemoglobin and MCHC were taken at baseline, at post treatment follow up visit Week 4, and at the end of study/early withdrawal. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||grams(g)/L||Full Range|Mean
1394699|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Heart Rate (HR)|HR was recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Beats per minute (bpm)||Full Range|Mean
1394700|NCT01313312|Primary|Mean Change From Baseline to End of Study/Early Withdrawal in Diastolic and Systolic Blood Pressure (BP)|Systolic and diastolic BP were recorded at screening, baseline and at each post baseline visit. Vital signs were measured with the subject in a sitting position after resting for 3 minutes. Outcome measure is reported for number of subjects with data available for analysis.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Millimeters of Mercury (mm Hg)||Full Range|Mean
1394701|NCT01313312|Primary|Assessment of the Long-term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)|A TEAE was reported as emergent if it arose (i.e. started or worsened in severity) in the treatment phase after the subject received study medication. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any adverse event (AE) that was assessed as a hypersensitivity reaction. TEAEs, AESIs, severe TEAEs, serious adverse events (SAEs), treatment related TEAEs, TEAEs leading to withdrawal and fatal SAEs are summarised by treatment cycle.|Up to Week 52|Subjects who entered the study and received at least one open label injection of Dysport® were evaluated for safety analysis. Only subjects with data available for analysis at the point of testing are reported.|||Participants|||Number
1394702|NCT01313299|Primary|Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)|MAS scale is used to assess muscle tone using a 6-point scale where: 0=No increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.|From Baseline (Day 1) to Week 4|Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.|||units on a scale||Standard Deviation|Mean
1394703|NCT01313299|Secondary|Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)|"DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited).~If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3."|From Baseline (Day 1) to Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed DAS assessment at baseline and week 4.|||units on a scale||Standard Deviation|Mean
1394704|NCT01313299|Secondary|Physician's Global Assessment (PGA) of Treatment Response|PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved).|At Week 4|ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4|||units on a scale||Standard Deviation|Mean
1394705|NCT01313273|Secondary|Reduction in Chromogranin A Serum Levels||Baseline, Week 96|Study early terminated due to poor enrollment||||||
1394706|NCT01313273|Secondary|Median Time to PSA Response||Week 96|Study early terminated due to poor enrollment||||||
1394707|NCT01313273|Secondary|Prostate Specific Antigen (PSA) Response||Week 96|Study early terminated due to poor enrollment||||||
1394708|NCT01313273|Primary|Progression-free Survival||Week 96|Study early terminated due to poor enrollment.||||||
1394709|NCT01313221|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard.|32 weeks|Safety analysis was based on treatment received, regardless of group assignment. 177 patients are included in group A, including 144 patients randomized to group A, 23 patients who were non-randomized and 10 patients randomized to group B but never received topical agents; Group B includes 133 patients who received etanercept plus ≥1 topical agent.|||participants|||Number
1394710|NCT01313221|Secondary|Health Resource Utilization: Ability to Perform Daily Activities|Participants were asked: How much did your psoriasis affect your ability to do your daily activities or household chores? Possible answers were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.|||participants|||Number
1394711|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Missed Hours From Work|Participants who were employed answered the following question regarding the past 4 weeks: How many hours per week did you miss from work because of your psoriasis? The number of participants with one or more missed hours of work per week is reported.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data; LOCF was used.|||participants|||Number
1394814|NCT01312909|Primary|4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12|The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).|Week 9 through Week 12|The full analysis set included all randomized participants.|||percentage of participants|||Number
1394712|NCT01313221|Secondary|Health Resource Utilization: Productivity While Working|Participants who were employed were asked: How much did your psoriasis affect your productivity while you were working? Possible responses were: a) A great deal; b) Quite a bit; c) Somewhat; d) Minimally; e) Not at all.|Baseline and 24 weeks|Full Analysis Set who were employed and with available data at each time point; LOCF was used. For the Etanercept 50 mg BIW group there were 106 and 100 participants with available data at Baseline and Week 24 respectively. For the Etanercept + Topical group there were 93 and 85 participants respectively.|||participants|||Number
1394713|NCT01313221|Secondary|Health Resource Utilization: Employment Status|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants were asked their employment status at Baseline and at Week 24.|Baseline and 24 weeks|Full Analysis Set; LOCF was used.|||participants|||Number
1394714|NCT01313221|Secondary|Health Resource Utilization: Out of Pocket Expenses|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess out of pocket expenses, participants answered the following question regarding the past 4 weeks: Not counting study mandated visits, what out-of-pocket expenses did you spend for the management of psoriasis (i.e. costs due to travelling to doctor appointment, hospital or clinic parking costs, alternative medications)?|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||Canadian dollars||Inter-Quartile Range|Median
1394715|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Who Needed Friend or Family Care|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. Participants answered the following question regarding the past 4 weeks: How many hours have you had a friend or family member take time off work to provide care or transportation? The number of participants who had paid or non-paid help for one or more hours is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
1394716|NCT01313221|Secondary|Health Resource Utilization: Number of Participants Requiring Paid Help With Chores|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of participants who needed paid help with chores, participants answered the following question regarding the past 4 weeks: How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)? The number of participants who paid for help one or more times is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
1394717|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Home Healthcare Visits|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of homecare visits, participants answered the following question regarding the past 4 weeks: How many times have you received care from a health professional in your home? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
1394718|NCT01313221|Secondary|Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider|Participants completed a questionnaire to assess their health resource utilization (HRU) related to psoriasis. To assess the number of visits to a healthcare provider, participants answered the following questions regarding the past 4 weeks: How many times have you been to any physician’s office or urgent care clinic? How many times have you seen a nurse practitioner, a physician assistant, a psychologist, a naturopath, an acupuncturist, a chiropractor, or other healthcare professional (HCP)? The number of participants with one or more visits is reported.|Baseline and 24 weeks|Full Analysis Set with available data; LOCF was used.|||participants|||Number
1394719|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24|The TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as postbaseline value - Baseline value so that a positive change indicates improvement.|Baseline and Weeks 12 and 24|Full analysis set; LOCF was used; n indicates the number of patients with available data for each scale at each time point.|||units on a scale||Standard Deviation|Mean
1394720|NCT01313221|Secondary|Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24|TSQM is a validated questionnaire consisting of 14 questions regarding a participant's perception of the level of satisfaction or dissatisfaction with the medication they are taking. Four scales are generated: side effects, effectiveness, convenience, and global satisfaction. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Change was calculated as Week 24 - Week 12 so that a positive change indicates improvement over time. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable with available data; n indicates the number of patients with available data for each scale.|||units on a scale||Standard Error|Least Squares Mean
1394721|NCT01313221|Secondary|Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline was calculated as Baseline value - postbaseline value so that a positive change indicates improvement.|Baseline and Week 12 and Week 24|Full analysis set with available data; LOCF was used|||units on a scale||Standard Deviation|Mean
1394815|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Energy Needed)|Mean energy needed to induce the seizure for each participant at each ECT administration they received. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing ECT forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||joules||Standard Deviation|Mean
1394722|NCT01313221|Secondary|Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Week 12 to Week 24 is calculated as: Week 12 value - Week 24 value so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set with available data|||units on a scale||Standard Error|Least Squares Mean
1394723|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments.~Change from Baseline \ is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement."|Baseline and Weeks 12, 16, 20, and 24|Full analysis set with available data; LOCF was used|||percent change||Standard Deviation|Mean
1394724|NCT01313221|Secondary|Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24|"The percentage of body surface area involved with psoriasis was measured by the same blinded assessor performing the PASI assessments. Change from Week 12 is presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement.~Change was adjusted for treatment using a mixed model."|Weeks 12, 16, 20, and 24|Efficacy analysis set with available data|||percent change||Standard Error|Least Squares Mean
1394725|NCT01313221|Secondary|Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|The sPGA scale is completed by the same blinded assessor performing the PASI assessments and is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|Weeks 12, 16, 20, and 24|Full Analysis Set, LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1394726|NCT01313221|Secondary|Percentage of Participants With a PASI 90 Response|The percentage of participants with a 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1394727|NCT01313221|Secondary|Percentage of Participants With a PASI 75 Response|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1394728|NCT01313221|Secondary|Percentage of Participants With a PASI 50 Response|The percentage of participants with a 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 12, 16, 20 and 24|Full analysis set with a non-missing response; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1394729|NCT01313221|Secondary|Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - postbaseline value / Baseline value * 100, so that a positive change indicates improvement.|Baseline and Weeks 12, 16, 20, and 24|Full analysis set, (all enrolled participants who had taken at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation) and with available data. Last Observation Carried Forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1394730|NCT01313221|Secondary|Percent Change in PASI From Week 12 to Weeks 16 and 20|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 presented as a percentage of the Week 12 value: Week 12 value - postbaseline value / Week 12 value * 100, so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12, Week 16 and Week 20|Efficacy Evaluable set with available data at each time point (indicated by n)|||percent change||Standard Error|Least Squares Mean
1394753|NCT01313208|Secondary|Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point|The HAQ-DI asks about the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each functional area are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
1394731|NCT01313221|Primary|Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value * 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.|Week 12 and Week 24|Efficacy Evaluable set, which included all randomized participants who had taken at least 1 dose of study drug and had at least 1 post-randomization efficacy evaluation, and with available data at Week 12 and Week 24.|||percent change||Standard Error|Least Squares Mean
1394732|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394733|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394734|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394735|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394736|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394754|NCT01313208|Secondary|Physician Global Assessment of Disease Activity at Each Time Point|The global assessment of the participant’s arthritis was assessed by the physician circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
1394932|NCT01311102|Primary|Pain During IUD Placement|"IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Immediately after IUD placement||||units on a scale of 0-9||Standard Deviation|Mean
1394737|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394738|NCT01313208|Secondary|Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point|The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). Sleep Disturbance measures the ability to fall asleep and to maintain restful sleep. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394739|NCT01313208|Secondary|Participant Assessment of Fatigue at Each Time Point|The participant's assessment of fatigue was collected using a single-item 100 mm visual analogue scale. The participant was asked to draw a vertical line through a horizontal line to indicate the degree of fatigue they experienced because of their condition over the past week. The horizontal line is 100 mm in length with ‘0’ and ‘no fatigue’ on the left end of the line and ‘100’ and ‘extreme fatigue’ on the right end of the line. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394740|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."|||percent overall work impairment||Standard Error|Least Squares Mean
1394741|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis. Percent activity impairment is derived from the patient’s assessment of the degree to which rheumatoid arthritis affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||percent activity impairment||Standard Error|Least Squares Mean
1394742|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."|||percent impairment while working||Standard Error|Least Squares Mean
1394743|NCT01313208|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point|This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to rheumatoid arthritis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants employed and included in the analyses at each time point."|||percent work time missed||Standard Error|Least Squares Mean
1394755|NCT01313208|Secondary|Patient's Global Assessment of Disease Activity at Each Time Point|The participant’s global assessment of their arthritis disease activity was assessed by the participant circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
1394744|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394745|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394746|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394747|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394748|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394749|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394750|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394751|NCT01313208|Secondary|Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point|The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The physical functioning subscale assesses limitations in physical activities because of health problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).|Baseline and Weeks 4, 12 and 24|"Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1394756|NCT01313208|Secondary|Patient Global Assessment of Joint Pain at Each Time Point|"The severity of the participant’s joint pain was assessed using a visual analog scale (VAS). The participant was asked to draw a mark through a 100 mm horizontal line to indicate how much pain they were experiencing “today, from ‘0’ (no pain at all) on the left end of the line to 100 (worst pain imaginable) on the right end of the line."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
1394757|NCT01313208|Secondary|Swollen 28-Joint Count (SJC28) at Each Time Point|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||swollen joints||Standard Deviation|Mean
1394758|NCT01313208|Secondary|Tender 28-Joint Count (TJC28) at Each Time Point|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||tender joints||Standard Deviation|Mean
1394759|NCT01313208|Secondary|Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:~28 tender joint counts,~28 swollen joint counts,~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and~C-reactive protein (CRP) in mg/dL.~The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
1394760|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point|The simplified disease activity index (SDAI) is a composite measure that sums the total number of: - 28 tender joint counts, - 28 swollen joint counts, - Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest, and - C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI low disease activity is defined as a score ≤ 11.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
1394761|NCT01313208|Secondary|Percentage of Participants Achieving SDAI Remission at Each Time Point|"The simplified disease activity index (SDAI) is a composite measure that sums the total number of:~28 tender joint counts,~28 swollen joint counts,~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0= lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and~C-reactive protein (CRP) in mg/dL.~The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI remission is defined as a score ≤ 3.3."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
1394762|NCT01313208|Secondary|Clinical Disease Activity Index (CDAI) Score at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest).~The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||scores on a scale||Standard Deviation|Mean
1394763|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
1394764|NCT01313208|Secondary|Percentage of Participants Achieving CDAI Remission at Each Time Point|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;~Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. CDAI remission is defined as a score ≤ 2.8."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
1394765|NCT01313208|Secondary|Percentage of Participants Achieving Count Remission at Each Time Point|"Count remission is achieved when a participant satisfies all of the following at any given time point: - 68 tender joint count ≤ 1, - 66 swollen joint count ≤ 1, - C-reactive protein (CRP) (in mg/dL) ≤1, and - patient global assessment of disease activity ≤ 1 (measured on a likert scale from 0 to 10 ranging from no activity at all to worst activity imaginable)."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
1394766|NCT01313208|Secondary|Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point|"The Multi-Dimensional Health Assessment Questionnaire (MDHAQ) is adapted from the standard HAQ and is used for the computation of the Routine Assessment of Patient Index Data 3 (RAPID3). The RAPID 3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do) and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10, both scored 0 (best) to 10 (worst). The three 0-10 scores for physical function, pain, and global assesment of health are added together for a composite score of 0 to 30. The RAPID3 composite score includes 4 categories: High Severity > 12, Moderate Severity = 6.1 - 12, Low severity = 3.1 - 6, and Remission ≤ 3."|Baseline and Weeks 4, 12, and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
1394767|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1394768|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein (CRP) level."|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1394769|NCT01313208|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-Reactive Protein level.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1394770|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at All Other Timepoints|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP)~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero to ten. A DAS28 above 5.1 indicates high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analyses at each time point."|||percentage of participants|||Number
1394771|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-Reactive Protein (CRP) level~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Baseline and Weeks 2, 4, 8, 16, 20 and 24|"Primary analysis set; LOCF was used. N indicates the number of participants included in the analysis at each time point."|||percentage of participants|||Number
1394772|NCT01313208|Secondary|Percentage of Participants Achieving DAS28 Remission at Week 12|"Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP)~Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity."|Week 12|Primary analysis set; LOCF was used|||percentage of participants|||Number
1394773|NCT01313208|Primary|Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12|"Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).~The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity."|Week 12|Primary analysis set (all randomized participants); last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
1394778|NCT01313117|Secondary|Total Neuropathy Score (TNS)|The Total Neuropathy score (TNS) is a validated score that combines signs, symptoms, and very limited nerve conduction studies (NCS). It was designed to assess peripheral nerve function and has been used as an endpoint in clinical trials of toxic neuropathy. The TNS is a composite scale with a range of values from 0 (normal) to 28 (severely affected). It includes data from 7 different categories. Patients are asked to assess the severity of sensory symptoms on a scale of 0 (no symptoms) to 4 (symptoms above knees or elbows, or functionally disabling). Next, 4 examination categories are assessed. These include pin sensation, vibration sensation, deep tendon reflexes, and strength. Signs are scored from 0 to 4 depending on severity. The nerve conduction portion of the scale consists of measurements of a motor (peroneal) and sensory (sural) nerve. Motor and sensory responses are graded on a scale of 0 to 4 depending on the severity of an abnormality.|4 months|Failure to reach the MTD precluded our ability to perform any meaningful analysis of the TNS.||||||
1394779|NCT01313117|Secondary|Cumulative Rate of Adverse Events||4 months||||participants|||Number
1394780|NCT01313117|Secondary|Proportion of Patients Who Complete the Proposed Regimen of Daily ALA||4 months||||participants|||Number
1394781|NCT01313117|Primary|Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile|Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.|4 months|Although our dose finding analysis suggested a maximum tolerated dose of 500mg daily, it should be noted that we failed to fully complete the Continual Reassessment Method (CRM) dose finding portion of the study. As such, we can not make confident dose finding statements on the basis of this trial.|||mg|||Number
1394782|NCT01313078|Primary|Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|11 months, 25 days||||Participants|||Number
1394783|NCT01313078|Primary|6 Month Progression Free Survival|Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as >20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.|6 months||||Participants|||Number
1394784|NCT01313039|Secondary|In Vitro Tamoxifen Response in Tumors|To assess for in vitro tamoxifen response in tumors following therapy with AZD6244.|2 years|||||||
1394785|NCT01313039|Secondary|Rate of ER Promoter Methylation in ER-negative/Low Breast Cancer|To determine the rate of ER promoter methylation in ER-negative/low breast cancer tumors that do not attain an ER response following AZD6244 therapy.|2 years|||||||
1394786|NCT01313039|Secondary|Changes in ER-regulated Gene Expression in E-negative/Low Breast Cancer|To assess for changes in ER-regulated gene expression in ER-negative/low breast tumors following AZD6244 therapy through assessment of protein expression by immunhistochemistry in paraffin embedded tissues.|2 Years|||||||
1394787|NCT01313039|Primary|Increase of ER Protein Expression in ER-Negative/Low Breast Cancer|"To evaluate in a clinical neoadjuvant model whether MEK inhibitor AZD6244 can increase ER protein expression in ER-negative/low breast cancer, as measured by the ER response rate by both standard immunohistochemistry and Allred Score."|2 years|Only 1 subject had evaluable study data|||participants|||Number
1394788|NCT01312961|Secondary|Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12|Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||number of inhalations/day||Standard Deviation|Mean
1394789|NCT01312961|Secondary|Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||number of awakenings/day||Standard Deviation|Mean
1394790|NCT01312961|Secondary|Change From Baseline in Evening Asthma Symptom Scores to Week 12|PM (post meridiem) symptom scoring system rates were participant’s overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1394791|NCT01312961|Secondary|Change From Baseline in Morning Asthma Symptom Scores to Week 12|AM (ante meridiem) symptom scoring system rates were participant’s overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1394792|NCT01312961|Secondary|Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12|The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1394811|NCT01312909|Secondary|Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52|The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.|Baseline, Weeks 12, 24, and 52|The full analysis set included all randomized participants. The longitudinal model included all participants regardless of observed visits.|||cigarettes smoked per day||Standard Error|Least Squares Mean
1394793|NCT01312961|Secondary|Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12|ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1394794|NCT01312961|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) to Week 12|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.|Baseline, Week 12|mITT population. Number analyzed = participants with at least one post-baseline assessment for each category.|||liters/minute||Standard Deviation|Mean
1394795|NCT01312961|Secondary|Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Baseline, Week 12|mITT population. Number of participants analyzed = participants with at least one post-baseline assessment.|||Liters||Standard Deviation|Mean
1394796|NCT01312961|Secondary|Percentage of Participants With Composite Asthma Events|Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.|Baseline up to Week 12|mITT population.|||percentage of participants|||Number
1394797|NCT01312961|Secondary|Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12|The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.|Baseline up to Week 12|mITT population.|||Probability of asthma exacerbation||95% Confidence Interval|Number
1394798|NCT01312961|Primary|Percentage of Participants With Asthma Exacerbation|An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.|Baseline up to Week 12|Modified intent-to-treat (mITT) population that included all randomized participants who received at least one dose of study drug. Participants were analysed in the treatment group to which they were randomized.|||percentage of participants|||Number
1394799|NCT01312948|Secondary|Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask|Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the patients usual mask|>4 hours monitored sleep study|Analysis was as per protocol|||apnea hypopnoea index||Standard Deviation|Mean
1394800|NCT01312948|Primary|Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask|"Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask.~Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability."|8 nights use|Analysis was as per protocol|||units on a scale||Standard Deviation|Mean
1394801|NCT01312909|Other Pre-specified|Change From Baseline in Pulse Rate at Week 12|Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.|Baseline, Week 12|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number of participants analyzed’ signifies participants evaluable for this outcome measure.|||beats per minute (bpm)||Full Range|Median
1394802|NCT01312909|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Week 12|Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.|Baseline, Week 12|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number of participants analyzed’ signifies participants evaluable for this outcome measure.|||millimeters of mercury (mmHg)||Full Range|Median
1394803|NCT01312909|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.|Baseline up to Week 12|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number of Participants Analyzed= participants evaluable for this outcome measure.|||Participants|||Count of Participants
1394804|NCT01312909|Other Pre-specified|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points|Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number analyzed’ signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
1394805|NCT01312909|Other Pre-specified|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points|The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses. Here, ‘Number analyzed’ signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
1394806|NCT01312909|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of Yes on actual attempt);preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior,aborted attempt or interrupted attempt),suicidal ideation (Yes on wish to be dead,non-specific active suicidal thoughts,active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).Here,number of participants with positive response (response of yes) to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported."|Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
1394807|NCT01312909|Other Pre-specified|Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.|First dose up to last dose (up-to Week 12) plus 30 days|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
1394808|NCT01312909|Other Pre-specified|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug Varenicline was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and SAEs.|First dose up to last dose (up-to Week 12) plus 30 days|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
1394809|NCT01312909|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.|First dose up to last dose (up-to Week 12) plus 30 days|The safety analysis set included all participants who took at least one dose of randomized study medication, including partial doses.|||Participants|||Count of Participants
1394810|NCT01312909|Secondary|Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52|The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.|Week 9 through Week 24; Week 9 through Week 52|The full analysis set included all randomized participants.|||percentage of participants|||Number
1394812|NCT01312909|Secondary|Daily Number of Cigarettes Smoked at Baseline|The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.|Baseline|The full analysis set included all randomized participants.|||cigarettes smoked per day||Standard Error|Mean
1394817|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Heart Rate)|Heart rate was taken immediately post ECT administration at each ECT visit. We averaged heart rate for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||Beats per minute||Standard Deviation|Mean
1394818|NCT01312844|Secondary|The Mean Levels of Physiological Measures of ECT (Blood Pressure)|Blood pressure was taken immediately post ECT administration at each ECT visit. We averaged Blood pressure for each participant at each ECT administration. The reported mean refers to the average among all participants in each group.|Duration of ECT treatment (usually 2 weeks)|Missing vitals forms for one participant in Scopolamine group (n=4), only reported data for 3 participants in Scopolamine group|||mmHg||Standard Deviation|Mean
1394819|NCT01312844|Secondary|The Mean Number of Moderate to Severe Side Effects|The mean number of adverse events classified as moderate to severe.|Duration of ECT treatment (usually 2 weeks)||||number of side effects||Standard Deviation|Mean
1394820|NCT01312844|Secondary|Number of ECT Treatments Withheld Due to Cognitive Impairment|The number of ECT treatments withheld during the course of the study due to cognitive impairment. In these cases, the participant would still be enrolled in the study but have a reduced # of ECTs. This outcome measure does not include patients who withdrew from the study.|Duration of ECT treatment (usually 2 weeks)||||ECT Treatments withheld||Standard Deviation|Mean
1394821|NCT01312844|Primary|Number of ECT Treatments Received to Achieve Response/Remission|The number of ECT treatments needed to achieve response (defined as a HAM D score less than half of baseline) and remission (defined as a HAM D score of less than 8). If patients HAM D score rose above these markers at any point in the study, they were not considered as responding or remitting.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression.|Duration of ECTtreatment (usually 2 weeks)|Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response and remission.|||# of ECT administrations||Standard Deviation|Mean
1394822|NCT01312844|Primary|Time to Response for Patients Receiving ECT|The number of days between baseline HAM D score and HAM D score showing response (defined as a HAM D score less than half of baseline). If patients HAM D score rose above this marker at any point in the study, they were not considered as responding.The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. .|Duration of ECT treatment (usually 2 weeks)|Only 3 (out of 4) Scopolamine patients and 2 (out of 3) placebo patients reached response|||days||Standard Deviation|Mean
1394823|NCT01312844|Primary|Change in Ham D 17 Scores|Change in Ham D 17 scores measured by the difference between baseline HAM D score and HAM D score at last ECT administration. The HAM D 17 measures severity of depression with 52 being most severe and 0 being no depression. A negative change score refers to a decrease in HAM D score, while a positive change score would refer to an increase in HAM D score.|At the time of ECT completion (about 2 weeks)||||units on a scale||Standard Deviation|Mean
1394824|NCT01312818|Secondary|Number of Subjects With Activated Caspases and Other Regulators of Apoptosis|Activation of caspases and other regulators of apoptosis in treated blast cells will be determined by Western analysis (correlative lab analysis).|From Day 1 to 30 Days After Last Dose|The trial was terminated early with only 2 patients so caspase samples were not sent for analysis.||||||
1394825|NCT01312818|Secondary|Number of Subjects Experiencing Drug Related Adverse Events|To characterize the toxicities of bortezomib, vorinostat and dexamethasone when used in combination. Toxicity will be graded using the NCI’s Common Terminology Criteria for Adverse Events (CTCAE 4.0).|Day 1 of Treatment to 30 Days Post Treatment||||participants|||Number
1394826|NCT01312818|Primary|Number of Subjects Who Achieved Complete Remission of Their Disease|Complete Remission (CR): A CR requires that the following be recorded concurrently: an absolute neutrophil count (segs and bands) > 1000/μL, no circulating blasts, platelets > 100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and < 5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent. If patients continue on with treatment, there can be no evidence of recurrence of ALL for at least 4 weeks.|Day 30||||participants|||Number
1394827|NCT01312805|Primary|Diagnosis Rate of Asthma||one year|We excluded those participants who had a previous diagnosis of asthma in the 14 months before the start of the study. This left the numbers seen above.|||Participants|||Count of Participants
1394828|NCT01312766|Secondary|Live Birth Rate||9 months after treatment||||percentage of participants|||Number
1394829|NCT01312766|Secondary|Number of Cleaved Embryos||two days after insemination||||embryos||Standard Deviation|Mean
1394830|NCT01312766|Secondary|Total Number of Inseminated Oocytes (IVF and ICSI)|number of oocytes that were inseminated via IVF or injected via ICSI technique.|on the day of oocyte retrieval||||oocytes||Standard Deviation|Mean
1394831|NCT01312766|Secondary|Ratio Mature/Total Number of Oocytes Retrieved.|Percentage of retrieved oocytes considered to be mature.|at the end of the stimulation.||||percentage of total oocytes retrieved|||Number
1394832|NCT01312766|Secondary|Number of Mature (Grade III Metaphase II) Oocytes Retrieved.||at the end of the stimulation.||||oocytes||Standard Deviation|Mean
1394833|NCT01312766|Secondary|Clinical Pregnancy Rate,|defined as a pregnancy showing ultrasound embryonic heart activity at 10 – 11 weeks after embryo transfer;|10 – 11 weeks after embryo transfer||||percentage of participants|||Number
1394834|NCT01312766|Secondary|Implantation Rate|defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;|10-11 weeks after embryo transfer||||percentage of embryos transferred||Standard Deviation|Mean
1394835|NCT01312766|Secondary|17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;||up to 23 days after treatment start||||pg/ml||Standard Deviation|Mean
1394836|NCT01312766|Secondary|Controlled Ovarian Stimulation Duration (Days)||up to 23 days after treatment start||||days||Standard Deviation|Mean
1394837|NCT01312766|Secondary|Positive b-hCG Test||up to 5 weeks after treatment start||||percentage of participants|||Number
1397046|NCT01290822|Secondary|Interatrial Delay (Between Right Atrium and Left Atrium)|Results could not be analyzed due to poor enrollment and lack of data.|13 minutes of testing; performed before CPB for allograft receipt|||||||
1394838|NCT01312766|Secondary|Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)|Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.|up to 28 days after treatment start|The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer.|||percentage of participants|||Number
1394839|NCT01312766|Secondary|Mean hMG Dose (Total);||up to 22 days after treatment start||||Internationa Units (IU)||Standard Deviation|Mean
1394840|NCT01312766|Primary|Total Number of Oocytes Retrieved||up to 24 days after treatment start||||number of oocytes||Standard Deviation|Mean
1394841|NCT01312519|Secondary|Time Necessary to Perform the Bone Marrow Procedure|The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.|Day 1 needle insertion through needle removal|Per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.|||seconds||Standard Deviation|Mean
1394842|NCT01312519|Primary|Subject Reported Level of Pain During Procedure|Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.|Day 1 during the needle insertion|as per protocol, 50 patients were enrolled in the study and randomized to the manual bone marrow sampling device or the battery powered device.|||units on a scale||Standard Deviation|Mean
1394843|NCT01312467|Secondary|Safety and Tolerability of Metformin Hydrochloride Treatment|All participants will be evaluable for toxicity from the time of their first dose of metformin. Since toxicities in this study are measured as categorical data, primary analysis shall be by tests of binomial proportions (e.g., Mantel-Haenszel chi-squared statistic). This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting.|Up to 16 weeks|45 participants were enrolled and 45 participants were analyzed for toxicity.|||adverse events|||Number
1394844|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Serum (Fasting and 2 Hour Postprandial Insulin and Glucose, Fasting IGF-1, IGFBP-1, IGFBP-3, Leptin, Adiponectin and Metformin Levels)|Data not collected.|Up to 16 weeks|Funding was not secured to complete the secondary and tertiary endpoints.||||||
1394845|NCT01312467|Secondary|Effects of Metformin Hydrochloride on Colorectal Mucosa Proliferation (Ki-67, Phosphorylated IGF-1 Receptor, Phosphorylated Insulin Receptor, Phosphorylated AKT, Phosphorylated mTOR, and Phosphorylated AMP Kinase)|Data not collected.|Up to 16 weeks|Funding was not secured to complete the secondary and tertiary endpoints.||||||
1394846|NCT01312467|Primary|Change in Activated S6serine235 (i.e., the Ratio of pS6serine235/S6serine235)|Tissue S6Ser235 immunostaining was analyzed by the study pathologist using Histo Score (HScore) analysis at baseline and post- metformin (Week 12). The Hscore is determined by estimation of the percentage of cells positively stained with mild, moderate, or strong staining intensity. The final score is determined by weighted estimate, as follows: Hscore = (# cell stained with High intensity/total # cells)x3 + (# cells stained with median intensity/total # cells)x2 + (# cells stained with low intensity/total # cells)x1. Mean and standard deviation of the change in the histo score (H score) of pS6serine235 from baseline were calcuated.|From baseline to 12 weeks|The analysis is based on 32 participants who have evaluable data.|||weighted ratio of staining cells||Standard Deviation|Mean
1394847|NCT01312428|Secondary|To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up|The study was terminated early, therefore, primary or secondary measures were not assessed.||||||
1394848|NCT01312428|Primary|To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.||6 week follow-up|The study was terminated early, therefore, primary or secondary measures were not assessed.||||||
1394849|NCT01312272|Secondary|Positive and Negative Syndrome Scale (PANSS) for Schizophrenia Total Score|"This is a frequently used instrument, initially developed by Kay, Opler, and Fiszbein, that assesses 30 different symptoms (categorized into positive, negative, and general psychopathology) on a scale from 1 to 7, based on clinical interview. It will be used to compare the psychopathology between the two treatment groups.~The maximum Total Score on the scale is 210 and the minimum score is 30, with higher values indicating more severe symptoms. The maximum scale of 210 is the sum of the scores from each symptom category (positive symptoms = range 7 to 49; negative symptoms = range 7 to 49; general psychopathology = range to 16 to 112).~Our outcome measure refers to the change in the PANSS Total Score. A greater decrease on the scale indicates greater improvement in symptoms (e.g., a participant with a change score of -20 improved more on the PANSS than a participant with a change score of -5)."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||change in units on scale||Standard Deviation|Mean
1394850|NCT01312272|Secondary|Facial Affect Recognition (Low Level Social Cognition)|Participants are asked to identify facial expressions of emotion in still photographs from the standardized stimulus set developed by Ekman. The test includes digitized color photos of eight different posers displaying facial expressions of six basic emotions plus neutral expressions. On each trial, a photo and a list of the seven possible expressions are simultaneously presented on the screen. The participant verbally identifies the emotion he/she believes is correct and the experimenter enters the response. The dependent measure is the total number correct.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
1394851|NCT01312272|Secondary|Social Perception Assessment (Low Level Social Cognition)|We will assess social perception using the Half-Profile of Nonverbal Sensitivity (Half-PONS). Brief scenes are shown that include facial expressions, voice intonations, and/or body gestures. Subjects select a label that best describes the situation. The dependent measure is the total number of correct labels.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
1394935|NCT01311102|Primary|Pain Scores During Overall IUD Placement|"Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being no pain and 9 being worst pain in life."|Before patient left the examination room at conclusion of procedure||||units on a scale of 0-9||Standard Deviation|Mean
1394852|NCT01312272|Secondary|Empathy|Empathy was assessed using the Emotional Perspective Taking Task (EPTT) (Derntl et al., 2009). In this task, subjects are presented with 60 digital images depicting two individuals in a social interaction, with one individual's face masked. Subjects are asked to infer the emotional expression of the masked face, selecting between two choices. Scenes portray 5 basic emotions as well as neutrality and each image is displayed for 4 s each.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
1394853|NCT01312272|Secondary|Theory of Mind Assessment (High Level Social Cognition)|The Awareness of Social Inference Test (TASIT Part III: Social Inference – Enriched) will be administered to assess theory of mind.|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
1394854|NCT01312272|Primary|Social Cognition Composite Measure|"Our primary outcome measure will be a composite score created by calculating the mean of the four main social cognition measures assessed in this study (two high-level measures and two low-level measures). Because these measures are not on the same scale, we will first z-score (center and scale) each of the four measures at each time point using the baseline mean and standard deviation of the whole sample and then calculate the mean of the z-scores to create the composite social cognition score."|Visit 2 (baseline), Visit 3 (1 week following, post-treatment)||||Change in z-score||Standard Deviation|Mean
1394855|NCT01312181|Primary|Total Dollar Value of Primary Drug Used in the Prior 30 Days|One primary study outcome was quantity of drug used in the prior 30 days, represented by the total dollar amount of primary drug used (QuantU) in the prior 30 days, as derived from the Time Line Follow Back (TLFB).|Assessed at end of treatment (60 days)||||Dollars||Standard Deviation|Mean
1394856|NCT01312181|Primary|Total Number of Days of Primary Drug Used in the Prior 30 Days|One primary study outcome was frequency of drug use, represented by the total number of days of primary drug used in the prior 30 days (NumDU) as derived from the Time Line Follow Back (TLFB).|Assessed at end of treatment (60 days)||||Days||Standard Deviation|Mean
1394857|NCT01312129|Primary|% BOLD Response Increase Above Baseline|Test whether Sulfasalazine, as compared to placebo, diminishes blood-oxygen-level dependent (BOLD) response to alcohol cues in the striatum and prefrontal cortex (PFC). BOLD response refers to brain activation in response to the presence of oxygen in a particular part of the brain. To test the hypothesis, we will compare Sulfasalazine treatment with placebo treatment. During the fMRI scan session, participants will be presented with the alcohol cue task. We will compare the difference in BOLD response during the presence of alcohol vs. a novel substance during the alcohol cue task. Outcome data collected during the alcohol cue task will provide us with BOLD response data for each intervention period. We will analyze the outcome data using FSL (Oxford Centre for Functional MRI of the Brain (FMRIB) Software – a collection of functional and structural brain image analysis tools).|Over two weeks||||% BOLD Response increase above baseline||Standard Deviation|Mean
1394858|NCT01312038|Primary|Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)|The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow|After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment|ears pre-treatment/ears post-treatment|||ratio|Participants|Standard Deviation|Mean
1394859|NCT01311895|Secondary|Number of Patients Who Reported no Pain or Mild Pain at 60 Minutes||60 minutes|"The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"|||Participants|||Count of Participants
1394860|NCT01311895|Secondary|Mean Change in Pain Intensity From Baseline to 60 Minutes|"Pain intensity is measured in numerical rating scale (NRS) units from 0 (no pain) to 10 (worst pain imaginable). The change here represents the NRS score given by the patients at 60 minutes subtracted from the score at baseline, before treatment in the Emergency Department."|60 minutes|"The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"|||units on a scale||Standard Deviation|Mean
1394861|NCT01311895|Primary|Number of Patients With Satisfactory Pain Management at 60 Minutes|The primary outcome is the proportion of patients in each arm who choose to forgo additional pain medication at 60 minutes. This is defined as the number of patients who declined additional pain medication at 60 minutes.|60 minutes|"The discrepancy between the number of patients enrolled and randomized and those included in analysis is due to the following.~H2O group: never given IV opioids (2), received ketorolac or additional opioids within the 60 min (7).~1+1 group: missing data (3), didn't receive 2nd dose within 60 min (2), received additional opioids within 60 min (2)"|||Participants|||Count of Participants
1394862|NCT01311687|Secondary|Time to First Worsening of Quality of Life (QOL) Domains|"Time to worsening in quality of life domains was calculated as the time from Baseline to the first worsened minimally important difference (MID), defined as the smallest change in a QOL score considered important to patients that would lead the patient or clinician to consider a change in therapy. MID thresholds were calculated in Standard Error of Measurement (SEM) units using the Baseline QOL data. Based on the MID, participants were classified as worsened according to the following:~For the EORTC QLQ-C30 global health status and functional scales and the EQ-5D health utility score, participants were classified as worsened if their change from Baseline score was less than -1 SEM.~For the EORTC QLQ-C30 symptom scores (fatigue and pain) and EORTC QLQ-MY20 disease symptoms and side effects scales, participants were classified as worsened if their change from Baseline score was greater than 1 SEM.~See previous outcome measures for definitions of each scale."|Assessed on Day 1 of the first 6 treatment cycles.|PRO population|||days||95% Confidence Interval|Median
1394890|NCT01311661|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM3 device.|0-3 weeks|FAS|||Percentage of asthma symptom free days||Standard Error|Mean
1394863|NCT01311687|Primary|Progression-free Survival (PFS) With a Later Cut-off Date|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl);~Urine M-component (absolute increase ≥ 200 mg/24 hours);~Bone marrow plasma cell percentage (absolute % ≥ 10%);~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks.|Intent-to-treat population|||weeks||95% Confidence Interval|Median
1394864|NCT01311687|Secondary|Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score|EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals “perfect health”, a score of 0 equals “death” and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1394865|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-MY20 Side Effects Domain|"The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).~The EORTC QLQ-MY20 Side Effects Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction in side effects (i.e.improvement in symptom) and positive values indicate increase in side effects (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1394866|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms|"The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective).~The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1394867|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Pain Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1394868|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Fatigue Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1394869|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1394936|NCT01311024|Secondary|Outpatient Antibiotic Treatment|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
1394870|NCT01311687|Secondary|Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"PRO population with available data at Baseline and each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
1394871|NCT01311687|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement."|Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6|"The Patient Reported Outcomes (PRO) study population includes any intent-to-treat study participants with 1 active treatment and 1 PRO measurement item completed. Only participants with available data at Baseline and each time point (indicated by n) are included."|||units on a scale||Standard Deviation|Mean
1394872|NCT01311687|Secondary|Time to Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|"Time to improvement in ECOG performance status defined as the time from randomization until at least a one category improvement from Baseline in ECOG performance status score.~The categories of the ECOG Performance Status Scale are as follows:~0: Fully active, able to carry on all pre-disease performance without restriction;~1: Restricted in physically strenuous activity but ambulatory and able to carry our work of a light or sedentary nature, e.g., light housework, office work;~2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.~Patients with a score of 3, 4 or 5 were excluded from participating in the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in ECOG performance status during the study|||weeks||Full Range|Median
1394873|NCT01311687|Secondary|Time to Improvement in Renal Function|"Time to improvement in renal function is defined as the time from randomization to at least one category improvement from Baseline in renal function.~Renal Function was categorized as (from best to worst):~Normal: creatinine clearance ≥80 mL/min;~Grade 1: creatinine clearance ≥60 to <80 mL/min;~Grade 2 : creatinine clearance ≥45 to < 60 mL/min.~Participants with creatinine clearance < 45 mL/min at baseline were be excluded from the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in renal function|||weeks||Full Range|Median
1394874|NCT01311687|Secondary|Time to Improvement in Bone Pain|"Time to improvement in bone pain is defined as the time from randomization to at least one category improvement from Baseline in bone pain category.~Bone pain was categorized (from best to worst) according to answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for patients with Multiple Myeloma Module (QLQ-MY20), Question 1, “Have you had bone aches or pain?”:~Not at all,~A little,~Quite a bit, or~Very much."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in bone pain|||weeks||Full Range|Median
1394875|NCT01311687|Secondary|Time to the First Hemoglobin Improvement|"Time to increased hemoglobin, defined as the time from randomization to at least one category improvement from Baseline in common terminology criteria for adverse events (CTCAE) grade for hemoglobin level. Hemoglobin categories are:~Normal;~CTCAE Grade 1: < lower limit of normal (LLN) to 10.0 g/dL;~CTCAE Grade 2: < 10.0 to <8.0 g/dL.~Participants with CTCAE Grade 3 anemia or worse at Baseline were excluded from the study."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population with improvement in hemoglobin during the study|||weeks||Full Range|Median
1394876|NCT01311687|Secondary|Duration of Response|Duration of response (calculated for responders only) is defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria assessed by the Independent Response Adjudication Committee.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population|||weeks||95% Confidence Interval|Median
1394877|NCT01311687|Secondary|Time to Response|"Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat responder population|||weeks||Full Range|Median
1394891|NCT01311661|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM3 device (overall mean number obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Puffs||Standard Error|Mean
1394937|NCT01311024|Secondary|Tympanostomy Tube Surgery|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
1394878|NCT01311687|Secondary|Time to Progression|"Time to progression (TTP) is calculated as the time from randomization to the first documented progression confirmed by a blinded, independent Response Adjudication Committee and based on the International Myeloma Working Group Uniform Response criteria (IMWG).~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl);~Urine M-component (absolute increase ≥ 200 mg/24 hours);~Bone marrow plasma cell percentage (absolute % ≥ 10%);~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population|||weeks||95% Confidence Interval|Median
1394879|NCT01311687|Secondary|Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria|"Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the Independent Response Adjudication Committee:~CR requires all of the following:~Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.~<5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.~No increase in size or number of lytic bone lesions.~Disappearance of soft tissue plasmacytomas.~PR requires all of the following:~≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.~Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days.~For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days.~≥ 50% reduction in the size of soft tissue plasmacytomas.~No increase in size or number of lytic bone lesions."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population|||percentage of participants|||Number
1394880|NCT01311687|Secondary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria|"Objective response is defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the Independent Response Adjudication Committee:~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.|Intent-to-treat population|||percentage of participants|||Number
1394881|NCT01311687|Secondary|Overall Survival With a Later Cut-off Date|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks.|Intent-to-treat|||weeks||95% Confidence Interval|Median
1394882|NCT01311687|Secondary|Overall Survival|Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From randomization until the data cut-off date of 07 September 2012. Maximum time on follow-up for survival was 70 weeks.|Intent-to-treat|||weeks||95% Confidence Interval|Median
1394883|NCT01311687|Secondary|Number of Participants With Adverse Events (AEs)|"An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that:~Results in death;~Is life-threatening;~Requires or prolongs existing inpatient hospitalization;~Results in persistent or significant disability/incapacity;~Is a congenital anomaly/birth defect;~Constitutes an important medical event.~The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0):~Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death."|From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 01 March 2013. Maximum time on treatment was 93 weeks.|Safety population (all randomized participants who received at least one dose of study drug (either Pomalidomide or Dexamethasone)).|||participants|||Number
1394884|NCT01311687|Primary|Progression-free Survival (PFS)|"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier.~Progressive disease requires 1 of the following:~Increase of ≥ 25% from nadir in:~Serum M-component (absolute increase ≥ 0.5 g/dl);~Urine M-component (absolute increase ≥ 200 mg/24 hours);~Bone marrow plasma cell percentage (absolute % ≥ 10%);~Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas;~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease."|From randomization until the data cut-off date of 07 September 2012. Maximum duration of follow-up for PFS assessments was 57 weeks.|Intent-to-treat population|||weeks||95% Confidence Interval|Median
1394885|NCT01311661|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event reporting includes 12 days into the subsequent washout or post-treatment period.|3 weeks + 12 days|Treated set|||Participants|||Number
1394892|NCT01311661|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||mL||Standard Error|Mean
1394894|NCT01311661|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Percentage||Standard Error|Mean
1394895|NCT01311661|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Liter/min||Standard Error|Mean
1394896|NCT01311661|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM3 device (overall means obtained during each period of randomised treatment will be compared). Means are adjusted for treatment, period, patient and study baseline.|0-3 weeks|FAS|||Liter/min||Standard Error|Mean
1394897|NCT01311661|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 PEF values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
1394898|NCT01311661|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
1394899|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
1394900|NCT01311661|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
1394901|NCT01311661|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS|||Liter/sec||Standard Error|Mean
1394902|NCT01311661|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FVC values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394903|NCT01311661|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post-dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394904|NCT01311661|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394905|NCT01311661|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394933|NCT01311102|Primary|Pain Measurement During Liquid Infusion/Sounding|"After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being no pain and 9 being worst pain in life."|Recorded at the end of the infusion||||units on a scale of 0-9||Standard Deviation|Mean
1394906|NCT01311661|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394907|NCT01311661|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at 23 h and 23 h 50 min after the last morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394908|NCT01311661|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the morning trial drug inhalation at the end of each 3 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394909|NCT01311661|Secondary|FEV1 Area Under Curve 12-24 Hours (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394910|NCT01311661|Secondary|FEV1 Area Under Curve 0-12 Hours (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min related to morning dose after 3 weeks|FAS|||Liter||Standard Error|Mean
1394911|NCT01311661|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min related to morning dose after 3 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.|||Liter||Standard Error|Mean
1394912|NCT01311557|Secondary|Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1394913|NCT01311557|Secondary|Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1394914|NCT01311557|Secondary|Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine|Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.|Day 0 (pre-vaccination) and 30 days post-vaccination|Seroprotection rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1394915|NCT01311557|Primary|Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were > 2.56 EU/mL for diphtheria or > 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.|30 days post-vaccination|Anti-Tetanus and anti-Diphtheria booster responses were assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
1394934|NCT01311102|Primary|Pain During Tenaculum Placement|"Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being no pain and 9 being worst pain in life. Taken to adjust for different pain thresholds among subjects"|Immediately following tenaculum placement||||units on a scale of 0-9||Standard Deviation|Mean
1394938|NCT01311024|Secondary|Hospital-diagnosed Pneumonia|Register follow-up up to 8 years after the vaccination of the younger sibling in the family|Up to 8 years|||||||
1394916|NCT01311557|Primary|Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine|Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were > 93 EU/mL for PT, > 170 EU/mL for FHA, > 115 EU mL for PRN, or > 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.|30 days post-vaccination|Anti-pertussis booster response were assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
1394917|NCT01311557|Primary|Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine|Anti-Pertussis titers (Pertussis toxoid [PT], Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1394918|NCT01311505|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.|||participants|||Number
1394919|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Respiratory Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since respiratory rate remained within normal limits throughout the study and there were no significant deviations from baseline.|||respirations/minute||Standard Deviation|Mean
1394920|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Oral Temperature|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since oral temperature remained within normal limits throughout the study and there were no significant deviations from baseline.|||Degrees Celsius||Standard Deviation|Mean
1394921|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Pulse Rate|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since pulse rate remained within normal limits throughout the study and there were no significant deviations from baseline.|||beats per minute||Standard Deviation|Mean
1394922|NCT01311505|Other Pre-specified|Clinically Significant Change From Baseline Supine Blood Pressure (BP)|Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.|Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)|Data was not summarized since supine systolic and diastolic BP remained within normal limits throughout the study and there were no significant deviations from baseline.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1394923|NCT01311505|Other Pre-specified|Number of Participants With Abnormal Safety Laboratory Test Values|Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.|Screening and Follow-up (1 week post-baseline)|Safety population included participants who received at least 1 dose of study medication.|||participants|||Number
1394924|NCT01311505|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC [0-∞] minus AUC[0-10])*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Percent AUC||Geometric Coefficient of Variation|Geometric Mean
1394925|NCT01311505|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hrs||Standard Deviation|Mean
1394926|NCT01311505|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1394927|NCT01311505|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hrs||Full Range|Median
1394928|NCT01311505|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1394929|NCT01311505|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||microgram*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1394930|NCT01311362|Primary|Cmax of Ambrisentan||after first dose, at steady-state and during St John's wort||||ng/ml||95% Confidence Interval|Geometric Mean
1394942|NCT01311024|Primary|Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules|Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age||||percentage of subjects|||Number
1394943|NCT01310868|Secondary|Survival at 24 Months||from the date of surgery to 24 months|Patients receiving 5-ala and carmustine wafers during surgical resection for glioblastoma multiforme that was confirmed peri/post-operatively|||months||95% Confidence Interval|Median
1394944|NCT01310868|Secondary|Time to Clinical Progression||from the date of surgery to the date of the first MRI scan fitting the criteria for progression, or the date the clinical detrioration or death was first reported|Patients receiving 5-ala and carmustine wafers during surgical resection for glioblastoma multiforme that was confirmed peri/post-operatively|||months||95% Confidence Interval|Median
1394945|NCT01310868|Primary|Safety, Tolerability, and Feasibility of Combination Intra-operative 5-ALA and Gliadel Wafers Prior to Adjuvant Radiotherapy Plus Temozolomide|"Procedure compliance: Proportion of 5-ALA resected patients who received Carmustine wafer implants (e.g to take into account rates of patients who did not receive Carmustine wafer implants due to 1) ventricular breach, 2) inaccurate peri-operative diagnosis, 3) intra-operative surgical decision)~Post-operative complication rate: Proportion of patients with a new post-operative deficit or surgical complication (wound infection, CSF leakage, intracranial hypertension)~No. of patients with chemoRT delay (i.e number who do not begin chemoRT 6 weeks after surgery) due to surgical complications*~No. of patients failing to start chemoRT due to surgical complications rather than tumour progression~No. of patients failing to complete chemoRT without interruption (RT with concomitant chemotherapy, and RT with concomitant plus adjuvant chemotherapy)~Proportion of patients with a lower WHO performance status after surgery with Carmustine wafers (at first post-operative clinic visit)"|Date of surgery to end of temozolomide and radiotherapy treatment (up to 34 weeks)|of 72 patients recruited, 62 received 5-ALA and carmustine wafers. Of these 62 patients, 59 were found to be eligible and included in the final analysis|||Participants|||Count of Participants
1394946|NCT01310855|Secondary|Safety and Tolerability||from date of randomisation to death|||||||
1394947|NCT01310855|Secondary|Time to Deterioration of Neurological Status||from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first.|||||||
1394948|NCT01310855|Secondary|Steroid Use||from randomization to first increase in dexamethasone dose|||||||
1394949|NCT01310855|Secondary|Progression-free Survival Rate at 6 Months||from the date of randomisation to 6 months|||||||
1394950|NCT01310855|Secondary|Radiographic Response Rate||from baseline scan to six week and 12 week scans|||||||
1394951|NCT01310855|Secondary|Overall Survival||from date of randomization to date of Death due to any cause.|||||||
1394952|NCT01310855|Primary|Progression-free Survival|"Progression free survival (PFS) defined as the time from the date of randomisation to the date of first progression or death due to any cause, whichever one comes first.~The progression definition will be based on modified RANO criteria (Wen 2010), such that progression will be defined as the earliest time that at least one of the following occurs:~Clinical deterioration~Failure to return for evaluation as a result of death or deteriorating condition~Or, by retrospective radiographic central review:~Any new lesion~Increase in ≥25% of sum of the products of perpendicular diameters of enhancing lesions compared with baseline scan, on stable or increasing doses of steroids (dexamethasone) compared to baseline (T1 post-contrast scan)~Clear progression of non-measureable disease~Significant increase in T2/FLAIR non-enhancing lesion – on stable or increasing steroids (dexamethasone) compared with baseline or best response not caused by co-morbid events."|from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken)||||months||90% Confidence Interval|Median
1394953|NCT01310803|Secondary|To Evaluate the Safety and Tolerability of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder|The occurrence of serious adverse events (SAEs), occurrence of local adverse reactions (LARs), results of vital signs, physical exams and laboratory test, and study discontinuation due to inability to complete valrubicin instillations|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.||||||
1394954|NCT01310803|Primary|To Evaluate the Efficacy of Maintenance Therapy With Valrubicin After Induction With Valrubicin, as Compared to Induction With Valrubicin Only in Subjects With CIS of the Bladder.|time interval from randomization to an event. An event is defined as tumor recurrence (any stage or grade), tumor progression to muscle-invasive bladder cancer (MIBC), metastatic bladder cancer or death from any cause, whichever occurs first. Tumor recurrence or progression must be documented by biopsy/transurethral resection of bladder tumor (TURBT).|2 years|No analysis completed due to limited enrollment (1 subject) prior to study termination.||||||
1394955|NCT01310777|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|The intent-to-treat (ITT) analysis set included all subjects who received study drug and completed at least 1 scheduled on-therapy study visit.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1394956|NCT01310699|Secondary|Percentage of Nonpolypoid (Flat) Missed Lesions|Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)|Adenoma by shape (i.e. Flat)|||percentage of adenomas|||Number
1394957|NCT01310699|Secondary|Percentage of Missed Lesions on Index Colonoscopy.|Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)||||percentage of adenomas|||Number
1394958|NCT01310699|Primary|Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm|Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.|One week (time of procedure plus time for pathology of polyp to be analyzed by histology)||||Participants|||Count of Participants
1394959|NCT01310582|Secondary|Time to Discharge From PACU||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery and transfer to PACU||||Minutes||Standard Deviation|Mean
1394960|NCT01310582|Primary|Time to Opening of Eyes||At 30-45 minutes, following discontinuation of volatile anesthetic at the end of surgery||||seconds||Standard Deviation|Mean
1394961|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394962|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.|During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394963|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394964|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394965|NCT01310413|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394966|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394967|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1397047|NCT01290822|Secondary|Atrial Latency||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
1394968|NCT01310413|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. “Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394969|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394970|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394971|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394972|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394973|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394974|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394975|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394976|NCT01310413|Secondary|Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)|Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394977|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394978|NCT01310413|Secondary|Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies||From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394979|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.|From Day U0 to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394980|NCT01310413|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. “Any pIMD” was defined as at least one pIMD experienced by the study subject.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394981|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day U0 up to Day U385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394982|NCT01310413|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.|From Day 0 up to Day 385|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394983|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394984|NCT01310413|Secondary|Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [axillary temperature (T) >= 38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394985|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >=39.0°C.|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394986|NCT01310413|Secondary|Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.|Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature (T) higher than or equal to (>=) 38.0 degrees Celsius (°C)]. “Any” was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature >= 39.0°C.|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394987|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).|During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subject|||Number
1394988|NCT01310413|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. “Any” was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).|During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)|Analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, solely on subjects with results available/accessible.|||Subject|||Number
1394989|NCT01310413|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.|At Day 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.|||Subject|||Number
1394990|NCT01310413|Secondary|Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.||At Days 0 and 42|Analysis was done on the Day 42 According-to-Protocol cohort for immunogenicity, that is, all evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0 and 42 time points.|||Subject|||Number
1394991|NCT01310413|Secondary|Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.|MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:28.|At Days 0, 42, 182 and 385|Analysis was done on the Day 42, 182 and 385 ATP cohorts for immunogenicity, that is, 50 percent of the evaluable subjects with 2 doses of vaccine/placebo administered and for whom assay results for antibodies against vaccine-homologous H5N1 haemagglutinin (HA) antigen were available for the Days 0, 42, 182 and 385 time points.|||Titer||95% Confidence Interval|Geometric Mean
1394992|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 385.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available|||Fold increase||95% Confidence Interval|Geometric Mean
1394993|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 385|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 385, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 385 were available|||Subjects|||Number
1394994|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Subjects|||Number
1394995|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 385|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Titer||95% Confidence Interval|Geometric Mean
1394996|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available|||Ratio||95% Confidence Interval|Geometric Mean
1394997|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 182|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 182, which included 50% of evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 182 were available|||Subject|||Number
1395005|NCT01310413|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Subject|||Number
1394998|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 42.|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Titer||95% Confidence Interval|Geometric Mean
1394999|NCT01310413|Secondary|Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Day 0 and Day 182|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Subject|||Number
1395000|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|"HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.~Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385."|At Day 0 and Day 182.|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Titre||95% Confidence Interval|Geometric Mean
1395001|NCT01310413|Secondary|Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.|At Days 21 and 42|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Ratio||95% Confidence Interval|Geometric Mean
1395002|NCT01310413|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.|"A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer higher than or equal to (>=) 1:40, or with a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.~As the analyses were performed and disclosed stepwise – i.e. as soon as a study phase was completed – several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity."|At Days 21 and 42|Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.|||Subject|||Number
1395003|NCT01310413|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (>=) the seroprotection cut-off of 1:40.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Subject|||Number
1395004|NCT01310413|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.|HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (>=) 1:10.|At Days 0 and 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 doses of the study vaccine/placebo at Days 0 and 21 and for whom assay results for antibodies against vaccine-homologous H5N1 HA antigen for the blood samples taken at Days 0 and 42 were available.|||Titer||95% Confidence Interval|Geometric Mean
1397048|NCT01290822|Primary|Cardiac Output|The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.|13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
1395006|NCT01310400|Secondary|Safety: Incidence of Solicited and Unsolicited Adverse Events|Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.|Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end||||percentage of subjects with AEs|||Number
1395007|NCT01310400|Secondary|Seroprotection|Seroprotection rate, defined as a post-vaccination HI titer of 1:40.|3 weeks after the 2nd vaccination||||percentage seroprotected subjects||95% Confidence Interval|Number
1395008|NCT01310400|Secondary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value|3 weeks after the 2nd vaccination||||Fold (ratio)|||Number
1395009|NCT01310400|Primary|Immunogenicity, Assessed by the Haemagglutination (HI) Test|Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.|3 weeks after the 2nd vaccination|According-to-protocol population: subjects who received both doses of influenza vaccine, with available pre- and post-vaccination titers and without major protocol violations|||percentage of participants||95% Confidence Interval|Number
1395010|NCT01310179|Secondary|Treatment Outcome and Percent Change in Tumor Volume|Measurement of tumor response to study drug, as measured by the percentage of change in tumor volume as measured by a physicial measurement using a ruler|Entry through Study Day 56||||participants|||Number
1395011|NCT01310179|Primary|Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment|Number of participants who had the most frequently observed undesirable effects after exposure to study drug|Entry through Study Day 56||||participants|||Number
1395012|NCT01310127|Primary|Macular Volume|Stratus OCT by experienced technician. Reviewed by principal investigator for quality of foveal centration and signal strength|6 weeks||||mm cubed||Standard Deviation|Mean
1395013|NCT01310127|Primary|OCT Retinal Thickness|Stratus OCT scan retinal thickness/volume tabular output report. An experienced ophthalmic technician obtained two scan patterns. The first was the fast macular thickness using 6 radial line scans through a common central axis (fovea) with a retinal thickness/volume tabular output and a retinal-thickness output report. Central retinal thickness was defined as the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris in the central 1 mm area of the minimum 7 mm posterior pole scan. All scans were reviewed by the principal investigator for quality of foveal centration and signal strength. Macular volume is an objective indicator of macualr swelling and can illustrate the amount of inflammation following surgery. Only the study eye was assessed.|Week 6||||micrometers cubed||Standard Deviation|Mean
1395014|NCT01310127|Primary|Summed Ocular Inflammation Score (SOIS)|An assessment of the cells and flare, signs of inflammation in ocular tissue. SOIS (summed ocular inflammation) = cells in the anterior chamber/1mmx1mm high powered field+flare/1mmx1mm high powered field. The score of the number of cells in the anterior chamber per 1mmx1mm high powered field ranges from 0-4: 0=no cells, 1=1-5 cell, 2=6-15 cells, 3=16-30 cells, 4>=30 cells.Flare scores range from 0-3:(0=none, 1=mild, 2=moderate, 3=severe). Cell+flare are added together (cell score + flare score=SOIS score) for a SOIS score (minimum score=0 and maximal score of 7). Higher numbers would indicate more inflammation.The SOIS scale could range from 0-7 with 0 indicating no cells, no flare and 7 reflecting maximal cell 4(>30 cell/high powered field +3 (severe flare).|Week 6||||units on a scale||Standard Deviation|Mean
1395015|NCT01310127|Primary|Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuities|ETDRs visual acuities measured at week 6 following uncomplicated phacoemulsification (phaco). ETDRS charts are a standardized eye chart for visual acuity testing accepted by the National Eye Institute and the Food and Drug Administration. The scale is 30-90 letters with higher numbers signifying improved visual acuities.|Week 6||||letters||Standard Deviation|Mean
1395016|NCT01309997|Secondary|Percentage of CD27+ B Cells in Responders (SCR) and Non-responders|%CD27+ B cells|6 months||||percentage of CD27+ B cells||Full Range|Mean
1395017|NCT01309997|Secondary|Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale|Maximum of 10 body areas. Each area can be graded 0 (best) to 4 (worst). Each of those grades requires a percentage of involvement. Improvement is measured by reduction of involvement in any grade and any body area.|6 months|Only patients who were evaluable at 6mo are included.|||participants|||Number
1395018|NCT01309997|Secondary|Baseline Histopathologic Score in the Two Treatment Arms|"Instrument: Nash dermal fibrosis grade. Measures extent of sclerosis in skin biopsies by histologic examination. Scale ranges from grade 0-5. Nash grade 5 is most severe fibrosis (0 is better outcome, 5 is worse outcome). No subscales are used in Nash grade. Please see table 1 in the reference for grading of dermal fibrosis.~Nash RA, McSweeney PA, Crofford LJ, Abidi M, Chen CS, Godwin JD, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study. Blood 2007;110:1388-96."|Enrollment|Only patients with skin biopsies at enrollment are included.|||units on a scale||Full Range|Median
1395019|NCT01309997|Secondary|Number of Patients Achieving Improvement in Cutaneous Sclerosis|Assessed by decrease of >= 0.2 units (where 0 is best and 3.0 is worst ) in the Scleroderma Health Assessment Questionnaire (SHAQ).|6 months|Only patients evaluable at 6 mo are included.|||participants|||Number
1395020|NCT01309997|Secondary|Cumulative Incidence of Treatment Failure|Defined as discontinuation of randomized treatment due to chronic GVHD progression or treatment intolerance or no significant clinical response in sclerosis.|6 months|Only patients who were evaluable for SCR are included.|||participants|||Number
1395021|NCT01309997|Secondary|Patients Who Were Able to Taper Corticosteroids|Patients who achieved a greater than or equal to 50% reduction in the daily corticosteroid dose at 6mo compared to baseline|6 months|Patients with no corticosteroid dose data missing from baseline or 6mo.|||participants|||Number
1395048|NCT01309802|Secondary|EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal|A combined reported score measuring 5 dimensions; mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels; no problems, some problems, extreme problems|baseline to 28 days|not were not collected||||||
1395049|NCT01309802|Secondary|Tissue Perfusion|Doppler perfusion imager and Periscan image analysis software|baseline to 28 days|Data were not collected||||||
1395022|NCT01309997|Primary|Significant Clinical Response|Assessed by decline in an affected area’s skin score as measured with the Vienna Skin Scale (from 4 [worst] to 2, 3 to 1, or 2 to 0 [best]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.|6 months|Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.|||participants|||Number
1395023|NCT01309919|Secondary|Insertion Time|Time of insertion of the IUD|immediate||||minutes||Standard Deviation|Mean
1395024|NCT01309919|Secondary|Satisfaction|Participant satisfaction with the IUD at 12 weeks post-insertion|12 weeks post-partum|We assessed satisfaction with the IUD of all participants who completed the 12-week follow up call|||% of participants who received an IUD|||Number
1395025|NCT01309919|Secondary|Expulsions|Incidence of spontaneous IUD expulsion in the six months after insertion|6 months|We assessed the number of expelled IUDs for all participants who had an IUD placed|||participants|||Number
1395026|NCT01309919|Primary|Bleeding Patterns|Number of bleeding and spotting days in the first six weeks and subsequent six weeks postpartum|12 weeks post-partum|We were able to analyze all returned bleeding diaries (25 participants in IUD Arm, 27 participants in Diary Arm)|||days||Full Range|Median
1395027|NCT01309893|Secondary|Overall Comfort|Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.|1 week|All eligible dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
1395028|NCT01309893|Secondary|Slit Lamp Findings ≥ Grade 2|Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.|1 week|All dispensed eyes|||eyes|Participants||Number
1395029|NCT01309893|Primary|Distance High Contrast logMAR Visual Acuity at 1 Week|Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week|Baseline & 1 week|All eligible, dispensed eyes|||logMAR|Participants|Standard Deviation|Least Squares Mean
1395030|NCT01309880|Secondary|Comfort|At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.|1 Weeks||||units on a scale|Participants|Standard Deviation|Least Squares Mean
1395031|NCT01309880|Secondary|Slit Lamp Findings|Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.|1 week|All Dispensed Eyes|||eyes|Participants||Number
1395032|NCT01309880|Primary|Visual Acuity|Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.|Dispensing & 1-week follow up|All Eligible, Dispensed Eyes|||logMAR|Participants|Standard Deviation|Least Squares Mean
1395033|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients’ everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1395034|NCT01309841|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who randomized multiple times at different centers. MMRM analysis includes all patients with baseline and at least 1 post-baseline assessment, while the Ns at Week 12 reflect patients providing data at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1395035|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup|Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue – First dose date/time.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||hours||95% Confidence Interval|Median
1395036|NCT01309841|Secondary|Change From Baseline in Mean Spontaneous Bowel Movements/Week|The number of spontaneous bowel movements/week was determined from the patient's eDiary.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of SBMs/week||Standard Error|Least Squares Mean
1395037|NCT01309841|Secondary|Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)|A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: “Did you feel like your bowels were completely empty after the bowel movement?” Patients provided a yes or a no response. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Percent days/week||Standard Error|Least Squares Mean
1395038|NCT01309841|Secondary|Change From Baseline in Stool Consistency (Bristol Stool Scale)|Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
1395039|NCT01309841|Secondary|Change From Baseline in Degree of Straining|A single-item straining question was asked via the eDiary: “How much did you strain during your bowel movement?” Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||units on a scale||Standard Error|Least Squares Mean
1395040|NCT01309841|Secondary|Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12||12 weeks|The ITT analysis set included all randomized patients who had evaluable data at baseline and post-baseline, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of Days||Standard Error|Least Squares Mean
1395041|NCT01309841|Secondary|Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours||12 weeks|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Hours||95% Confidence Interval|Median
1395042|NCT01309841|Secondary|Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12|Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The LIR subgroup used 1 or more laxative classes for at least 4 days in the 2 weeks prior to entry and reported moderate to very severe symptoms.|||Number of patients|||Number
1395043|NCT01309841|Primary|Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12|Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.|Baseline (Week 1) to end of treatment (Week 12)|The ITT analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Number of patients|||Number
1395044|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Both a Clinic Systolic and Diastolic Blood Pressure Response|Systolic/diastolic blood pressure is the arithmetic mean of the 3 serial sitting systolic/diastolic blood pressure measurements. Percentage of participants who achieved both a sitting clinic systolic and diastolic blood pressure response, defined as systolic blood pressure less than 130 mm Hg and diastolic blood pressure less than 80 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants||95% Confidence Interval|Number
1395045|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieved Target Diastolic Blood Pressure <80 mm Hg|Diastolic blood pressure is the arithmetic mean of the 3 serial sitting diastolic blood pressure measurements. Percentage of participants at Week 52 who achieved a sitting clinic diastolic blood pressure response, defined as less than 80 mm Hg.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants||95% Confidence Interval|Number
1395046|NCT01309828|Secondary|Percentage of Participants at Final Visit Who Achieve Target Systolic Blood Pressure <130 mm Hg|Systolic blood pressure is the arithmetic mean of the 3 serial sitting systolic blood pressure measurements. Percentage of participants who achieve a sitting clinic systolic blood pressure response defined as less than 130 mm Hg at Week 52.|Week 52|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants||95% Confidence Interval|Number
1395047|NCT01309828|Primary|Number of Participants With at Least 1 Adverse Event (AE)|An AE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious AE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|From the first dose of open-label study drug until 14 days (or 30 days for a serious adverse event) after the last dose of open- label study drug (up to 56 weeks).|Safety analysis set - All participants who received at least 1 dose of open-label study drug.|||participants|||Number
1395050|NCT01309802|Secondary|Patient Satisfaction|The Optum SF-12v2® Health Survey - A Short Patient Reported Survey Measuring Health Using Excellent, Very Good, Good, Fair and Poor Indicators. On a scale from Excellent to Poor, Excellent being the maximum outcome. Good is scored as average. Patient satisfaction assessed as the percentage of participants who responded; Excellent, Very Good and Good on the health survey on average feeling between baseline and 28 days.|baseline to 28 days||||percentage of participants|||Number
1395051|NCT01309802|Secondary|Hand Function|Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure|baseline to 28 days|Data were not collected||||||
1395052|NCT01309802|Secondary|Quality of Life|SF-12v2® Health Survey - Pain Enhanced|change from baseline to 28 days|Data were not collected,||||||
1395053|NCT01309802|Primary|Percentage of Patient Reported Pain-free Days|Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]. Subjects reporting total number of pain free days within the time period of 0-28 days.|baseline to 28 days||||percentage of pain free days|||Number
1395054|NCT01309737|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395055|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means ability to work was not affected by psoriasis, and 10 means ability to work was completely affected by psoriasis. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1395056|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants evaluable for specified timepoint for each arm, respectively.|||percentage of scheduled hours||Standard Deviation|Mean
1395057|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure for specified parameter for each arm, respectively.|||hours||Standard Deviation|Mean
1395058|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. 'n' signifies participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.|||percentage of participants|||Number
1395059|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants (currently employed [Emp]) answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants (unemployed [UEmp]) answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||participants|||Number
1395060|NCT01309737|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist and Rheumatologist. Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team's decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|Baseline, Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from a site were excluded due to GCP compliance issues. 'n' signifies participants evaluable at specified time point for each arm, respectively.|||events|||Number
1395061|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline,Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||mm||Standard Deviation|Mean
1395062|NCT01309737|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395063|NCT01309737|Secondary|Joint Pain Assessment (JPA) Score|"The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain."|Baseline, Week 8,16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395064|NCT01309737|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of Participants|||Number
1395065|NCT01309737|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of participants|||Number
1395066|NCT01309737|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands Scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395067|NCT01309737|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale and 7 items comprising the depression subscale. Each item has response options ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total HADS score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 8, 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395068|NCT01309737|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395069|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."|||units on a scale||Standard Error|Least Squares Mean
1395070|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395071|NCT01309737|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."|||units on a scale||Standard Error|Least Squares Mean
1395072|NCT01309737|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395073|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."|||percentage of participants||95% Confidence Interval|Number
1395115|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses from both the immediate intervention group and the wait list control group.|||correlation coefficient|||Number
1395074|NCT01309737|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
1395075|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'N' (number of participants analyzed) signifies participants with baseline nail psoriasis and who were unique in longitudinal model.|Baseline,Week 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues."|||percent change||Standard Error|Least Squares Mean
1395076|NCT01309737|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number of psoriasis affected nails (presence of psoriatic manifestations on the nail matrix / nail bed) were assessed and reported. 'N' (number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. 'n' signifies participants evaluable at specified time point for each arm."|||nails||Standard Deviation|Mean
1395077|NCT01309737|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. 'n' signifies participants evaluable at specified time point for each arm.|Baseline,Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1395078|NCT01309737|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.'n' signifies participants evaluable at specified time point for each arm.|Baseline, Week 8, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP non-compliance. N(number of participants analyzed) signifies participants (with baseline nail psoriasis) who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1395079|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked)."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of participants||95% Confidence Interval|Number
1395116|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks|Correlation between baseline soluble transferrin receptor and the change in hemoglobin from the baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject in both the immediate intervention and the wait list control groups were missing responses.|||correlation coefficient|||Number
1395080|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
1395081|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
1395082|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N'(number of participants analyzed) signifies the unique participants in the longitudinal model."|||percent change||Standard Error|Least Squares Mean
1395083|NCT01309737|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of BSA||Standard Deviation|Mean
1395084|NCT01309737|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies the unique participants in the longitudinal model."|||percent change||Standard Error|Least Squares Mean
1395085|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395086|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4 and where higher scores indicate greater severity of psoriatic lesions."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395087|NCT01309737|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. N (number of participants analyzed) signifies the unique participants in the longitudinal model."|||units on a scale||Standard Error|Least Squares Mean
1395088|NCT01309737|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1395089|NCT01309737|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
1395090|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues.Here 'n' signifies those participants who were evaluable for this measure at specified time point for each arm, respectively."|||percentage of participants|||Number
1395091|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|"FAS. Analysis population for Placebo, CP-690,550 groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used."|||percentage of participants||95% Confidence Interval|Number
1395133|NCT01309646|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
1395092|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
1395093|NCT01309737|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
1395094|NCT01309737|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
1395095|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
1395096|NCT01309737|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
1395441|NCT01306305|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population|||Subjects|||Number
1395097|NCT01309737|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
1395098|NCT01309737|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included participants who were randomized to study, received at least 1 dose investigational drug. Participants from 1 site were excluded due to GCP compliance issues. 'N' (number of participants analyzed) were participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.|||percent change||Standard Error|Least Squares Mean
1395099|NCT01309737|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
1395100|NCT01309737|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline."|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
1395101|NCT01309737|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
1395102|NCT01309737|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 4,16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1395145|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395103|NCT01309737|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1395104|NCT01309737|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline."|Week 16|FAS included participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP compliance issues. NRI method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
1395105|NCT01309737|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to GCP non-compliance. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
1395106|NCT01309737|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS): participants who were randomized to study and received at least 1 dose investigational drug (CP-690,550 or placebo). Participants from 1 site were excluded due to good clinical practices(GCP) compliance issues. Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used.|||percentage of participants|||Number
1395107|NCT01309672|Secondary|Number of Patients With Toxicity of Abiraterone Acetate|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|All participants receiving at least some protocol treatment|||Participants|||Number
1395108|NCT01309672|Secondary|Overall Survival||3 years||||months||95% Confidence Interval|Median
1395109|NCT01309672|Secondary|Objective Progression-free Survival|Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.|3 years||||months||95% Confidence Interval|Median
1395110|NCT01309672|Secondary|Number of Patients With PSA Partial Response|PSA reduction to < 4 ng/ml, but >0.2 ng/ml|12 months||||Participants|||Count of Participants
1395111|NCT01309672|Primary|Number of Patients With Undetectable PSA|undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.|12 months|All patients who received at least 1 dose of protocol treatment|||Participants|||Count of Participants
1395112|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance|Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.|||correlation coefficient|||Number
1395113|NCT01309659|Secondary|Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance|Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 12 weeks|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses in the immediate intervention group and one subject was missing responses in the wait list control group.|||correlation coefficient|||Number
1395114|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses from the wait list control group.|||correlation coefficient|||Number
1395117|NCT01309659|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Five subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.|||participants|||Number
1395118|NCT01309659|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12."|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Three subjects in both the immediate intervention group and the wait list control groups were missing responses.|||participants|||Number
1395119|NCT01309659|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as “frail” at baseline and changed to “not frail” at week 12.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Two subjects in the immediate intervention group and 5 subjects in the wait list group did not respond.|||participants|||Number
1395120|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as for each of the groups there was missing responses for subjects.|||change in the total score||Standard Deviation|Mean
1395121|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 2 subjects for each of the groups did not have a response for this data.|||change in Z-score||Standard Deviation|Mean
1395122|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test.|Baseline, 12 week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Wait List Control did not respond to this during their clinic visit.|||change in Z-score||Standard Deviation|Mean
1395146|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395123|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.|Baseline, 12 Week|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Immediate Intervention Group did not respond to this during their clinic visit.|||change in Z-Score||Standard Deviation|Mean
1395124|NCT01309659|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:~“In the past month, on average, have you been feeling unusually tired during the day?” is answered “yes” and indicated as “all of the time” or “most of the time.”~“In the past month, on average, have you felt unusually weak?” is answered “yes” and indicated as “all of the time” or “most of the time.”~Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.~The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at week 12 as reported by the subject."|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Results reported by number of participants reporting change from their baseline exhaustion, and low energy.|||participants|||Number
1395125|NCT01309659|Secondary|Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)|Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks.|baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.|||correlation coefficient|||Number
1395126|NCT01309659|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to week 12. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Number of participants analyzed is correct- 2 subjects for Waitlist Group did not respond.|||t score||Standard Deviation|Mean
1395127|NCT01309659|Secondary|Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B|To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. The number of participants analyzed is correct as 4 subjects for the wait list control group did not respond to this during their clinic visit.|||change in seconds per completed circle||Standard Deviation|Mean
1395128|NCT01309659|Secondary|Number of Participants Who Had a Hemoglobin Increase >= 1g/dL|To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12.|baseline, 12 weeks||||participants|||Number
1395129|NCT01309659|Primary|Change in 6 Minute Walk Test Results|Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented.|Baseline, 12 weeks|All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.|||meters||Standard Deviation|Mean
1395130|NCT01309646|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1395131|NCT01309646|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1395132|NCT01309646|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||Participants|||Count of Participants
1395134|NCT01309646|Secondary|Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.|Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395135|NCT01309646|Secondary|Concentrations of Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1395136|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395137|NCT01309646|Secondary|Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||titers||95% Confidence Interval|Geometric Mean
1395138|NCT01309646|Secondary|Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395139|NCT01309646|Secondary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1395140|NCT01309646|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395141|NCT01309646|Secondary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/mL.|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1395142|NCT01309646|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).|A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).|At Month 0 and Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395143|NCT01309646|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1395144|NCT01309646|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 5|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.|||Participants|||Count of Participants
1395198|NCT01308918|Secondary|Number of Complications Associated to the GlideRite DLT Stylet® Utilization|Complications defined either as oxygen desaturation below 95%, oxygen desaturation below 90%, minor bleeding, anatomic lesion.|1 hour (Post intubation)||||Participants|||Number
1395199|NCT01308918|Secondary|Correlation Between the Difficult Intubation Score and a Successful Intubation||1 hour (Post intubation)|||||||
1395147|NCT01309581|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)|The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).|Change from beginning of ECT treatment to end; on average 3 weeks|||||||
1395148|NCT01309581|Primary|Hamilton Rating Scale for Depression-24 (HRSD24)|"The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the gold standard clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability."|Change from beginning of ECT treatment to end; on average 3 weeks|||||||
1395149|NCT01309451|Primary|OCT CST|change in optical coherence tomography central subfield thickness|change in OCT CST from baseline to twelve months||||microns||Standard Deviation|Mean
1395150|NCT01309451|Primary|Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline|Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|baseline to 12 month|The unit of measure is EYES rather than actual number of participants|||letters||Standard Deviation|Mean
1395151|NCT01309386|Secondary|Average Change From Baseline in Amount of Rescue Medication Over Time|Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication. Average amount was the averages of all doses recorded during the baseline period or during each week (Week 1, 2, 3, 4, 5, 6, 7 and 8).|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Milligram (mg)||Standard Deviation|Mean
1395152|NCT01309386|Secondary|Number of Doses of Rescue Medication Over Time|Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Morphine-equivalent doses||Standard Deviation|Mean
1395153|NCT01309386|Secondary|Total Number of Days of Rescue Medication Over Time|Total number of days of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (drug used to control pain) were used as rescue medication.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Days||Standard Deviation|Mean
1395154|NCT01309386|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)|"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved."|Week 1, 4 and 8|Full analysis set (FAS) population; here ‘N’ signifies those participants evaluable for this outcome measure and ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Participants|||Number
1395155|NCT01309386|Secondary|Number of Participants Who Discontinued Study Treatment Due to Lack of Efficacy|Number of participants who discontinued the treatment due to lack of efficacy were assessed throughout the study.|Baseline up to Week 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Participants|||Number
1395156|NCT01309386|Secondary|Change From Baseline in Numerical Rating Scale (NRS) at Week 1, 2, 3, 4, 5, 6, 7 and 8|Average pain intensity was assessed using an 11-point NRS to measure the pain level for the past 24-hours where 0=no pain to 10=pain as bad as you can imagine.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data. Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Unit on scale||Standard Deviation|Mean
1395157|NCT01309386|Primary|Percentage of Participants Who Achieved Pain Control|Pain control was considered to be achieved for participants who met both of the following criteria for any consecutive 3 days during the first week of treatment period: a) Change from baseline of mean 24 hour numerical rating scale (NRS) (an 11-point NRS is used to measure the pain level where 0=no pain to 10=pain as bad as you can imagine) score less than +1.5, and b) when the frequency of rescue medication was twice or less per day.|Week 1|Full analysis set (FAS) population included all participants who were randomly assigned, received at least 1 dose of study drug and had post-baseline efficacy data.|||Percentage of Participants||95% Confidence Interval|Number
1395158|NCT01309360|Secondary|Number of Participants With Subjective Adverse Events as a Measure of Safety and Tolerability.|In groups A, B and C was determined the rate of subjective clinical signs of increased Met-Hb-Levels : headaches or dizziness, when correlated with the peak-Met-Hb-Level.|Outpatients were followed for the duration of hospital stay, an average of six hours.||||participants|||Number
1395159|NCT01309360|Primary|Onset Time.|Time from beginning of administration of the local anesthetic until complete sensoric block.|within 60 minutes after administration of the local anesthetic|In some cases the investigators were not able to exactly determine an onset time, so in cases of block failure (supplementation needed) or emergency situations outside this study (onset time not examined). Therefore the number of participants analyzed concerning onset time is lower then the total number of outpatients in each group.|||minutes||Standard Deviation|Mean
1395160|NCT01309360|Primary|Number of Participants With Complete Motor Blocks|To examine the extent of the motor block the manual muscle function test after Vladimir Janda was used. As a complete motor block was defined, when no motion (grade zero after Janda) of muscles innervated by the four blocked nerves (musculocutaneous, median, radial and ulnar nerve) was observed within 60 minutes after administration of the local anesthetic.|Within 60 minutes after administration of the local anesthetic|The analysis was per protocol.|||participants|||Number
1395161|NCT01309360|Secondary|Number of Participants With Objective Adverse Events as a Measure of Safety and Tolerability|In groups A, B and C was determined the rate of objective clinical signs of increased Met-Hb-levels : drops in oxygen saturation <93% using pulseoximetry or lip cyanosis.|Outpatients were followed for the duration of hospital stay, an average of six hours.||||participants|||Number
1395162|NCT01309360|Secondary|Maximum Concentrations of Methemoglobin|Concentration of Methemoglobin (Met-Hb) was measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent. The maximum amount was reached in every case two or three hours after administration of the local anesthetic.|0,1,2,3,4 hours post-dose|Methemoglobin (Met-Hb) levels were measured using spectrophotometry prior to the anesthesia (baseline value) and then hourly after performing the block until a clear decrease became apparent.The mean maximum Met-Hb was estimated in each group.|||percentage of methemoglobin||Standard Deviation|Mean
1395163|NCT01309360|Primary|Number of Participants With Complete Sensory Block|The number of outpatients with complete sensory block of all 4 nerves (n.musculocutaneous, n.radialis, n.ulnaris,n.medianus) was registrated in each group.|60 minutes after administration of the local anesthetic|The analysis was per protocol.|||participants|||Number
1395164|NCT01309308|Secondary|The Duration of Latency Until Labor|The period (in days) from the last cervical measurement to the start of second phase of labor.|15 days||||days||Standard Deviation|Mean
1395165|NCT01309308|Primary|Cervical Shortening|Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.|2days|analysis was per person who delivered|||millimeters||Standard Deviation|Mean
1395166|NCT01309282|Secondary|Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events|An Adverse Events (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect|Up to Month 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.|||Participants|||Number
1395167|NCT01309282|Secondary|Number of Participants With Incidence of Infectious Events|Follow-up of the infectious events was done after Month 6 visit, Month 12 visit and Month 24 visit.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.|||Participants|||Number
1395168|NCT01309282|Secondary|Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions|An infusion reaction or injection site reaction is an event that occurs after infusion or injection which may include hypersensitivity reactions or anaphylactic reactions.|At Months 6, 12 and 24|Safety population was used for the analysis which included all participants who received at least one dose of study drug, whether prematurely withdrawn from the study or not and who complied with the criteria for inclusion.|||Participants|||Number
1395169|NCT01309282|Secondary|Number of Participants on Each Pattern of Re-treatment|"There are two patterns of re-treatment, namely treat-to-target and according to the clinic.~Treat-to-target: a new cycle every 6 months if not in remission, with the participant receiving no new course of treatment as long as he is in remission.~On demand (according to clinic): a new cycle when, in an assessment performed at least 16 weeks after the last treatment cycle, the participant shows moderate or high disease activity [DAS28 > 3.2 or difference in DAS28 (ΔDAS28) > 0.6]"|Up to Month 24|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.|||Participants|||Number
1395170|NCT01309282|Secondary|Reason for Change From First TNF-inhibitor Therapy to Rituximab|Adverse event, primary and secondary insufficient responses and monoclonal gammopathy were the reasons for starting rituximab therapy.|At Screening|The analysis was conducted with all 9 participants who complied with the inclusion and exclusion criteria, thus defining the full analysis set.|||Participants|||Number
1395171|NCT01309282|Secondary|Mean Change Form Baseline in Functional Capacity at Month 24|The functional capacity was analyzed using Health Assessment Questionnaire-Disability Index (HAQ-DI). It is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 domains (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each domain are scored from 0 to 3 (0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do). Overall score was computed as sum of domain scores and divided by the number of domains. A total possible score ranged from 0 (best) to 3 (worst).|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, the results are presented only for the participants with available data and who completed Month 24 visit (n=7).|||Scores on a scale||Standard Deviation|Mean
1395172|NCT01309282|Secondary|Mean Change From Baseline in Severity of Pain at Month 24|The patient's assessment of pain was performed using a 100 mm VAS ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
1395173|NCT01309282|Secondary|Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24|The Patient’s Global Assessment of disease activity was assessed using VAS. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
1395174|NCT01309282|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24|The Physician’s Global Assessment of disease activity was assessed using a Visual Analogue Scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
1395175|NCT01309282|Secondary|Mean Change From Baseline in C-reactive Protein at Month 24|The C-reactive protein is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Milligrams/liter||Standard Deviation|Mean
1395176|NCT01309282|Secondary|Mean Change From Baseline in ESR at Month 24|The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Millimeter (mm)/hour||Standard Deviation|Mean
1395177|NCT01309282|Secondary|Mean Change From Baseline in SJC at Month 24|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Swollen joints||Standard Deviation|Mean
1395178|NCT01309282|Secondary|Mean Change From Baseline in TJC at Month 24|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Tender joints||Standard Deviation|Mean
1395179|NCT01309282|Primary|Mean Change From Baseline in Disease-activity Score 28-Erythrocyte Sedimentation Rate at Month 24|The disease-activity score 28 (DAS28) score is a measure of validated instrument for the assessment of the overall severity of RA disease activity calculated using the tender joint count (TJC), swollen joint count (SJC), patient's global assessment of disease activity, and erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline (Day 0) and Month 24|The analysis was conducted with all the participants who complied with the inclusion and exclusion criteria, thus defining full analysis set (n=9). However, data is presented only for those participants who completed Month 24 visit (n=8).|||Scores on a scale||Standard Deviation|Mean
1395180|NCT01309269|Primary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during study period considered.|||microgram (mcg)||Standard Deviation|Mean
1395181|NCT01309269|Primary|Percentage of Participants Within Pre-defined Range of Hemoglobin Values|Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10–12 g/dL, 11-13 g/dL, and 10-13 g/dL.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.|||percentage of participants|||Number
1395182|NCT01309269|Primary|Hemoglobin Levels at Monthly Intervals|Hemoglobin levels were measured as grams/deciliter (g/dL).|Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24|Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.|||g/dL||Standard Deviation|Mean
1395200|NCT01308918|Secondary|Number of Attempt to Obtain a Successful Intubation||1 hour (Post intubation)||||Attempts|||Number
1395183|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, Participants With Viral Resistance|Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Resistance Analysis Set|||participants|||Number
1395184|NCT01309243|Secondary|Development of HIV-1 Drug Resistance Through Week 96, All Participants|Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.|Baseline to Week 96|Full Analysis Set|||percentage of participants|||Number
1395185|NCT01309243|Secondary|Change From Baseline in Fasting Triglycerides at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
1395186|NCT01309243|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
1395187|NCT01309243|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
1395188|NCT01309243|Secondary|Change From Baseline in Fasting Total Cholesterol at Week 48||Baseline to Week 48|Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.|||mg/dL||Standard Deviation|Mean
1395189|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.|||cells/μL||Standard Deviation|Mean
1395190|NCT01309243|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.|||cells/μL||Standard Deviation|Mean
1395191|NCT01309243|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm.|Baseline to Week 96|Full Analysis Set|||percentage of participants|||Number
1395192|NCT01309243|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm.~The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time."|Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1395193|NCT01309204|Primary|Mean Diurnal IOP Change From Baseline at Month 3|Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Baseline (Day 1), Month 3|Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1395194|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)|The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|All eligible, dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
1395195|NCT01309100|Primary|Visual Acuity (Investigational vs Acuvue Oasys Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.|1 week|All eligible, dispensed eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
1395196|NCT01309100|Secondary|Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)|The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.|1 week|1-Week Follow-up, All Eligible, Dispensed Eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
1395197|NCT01309100|Primary|Visual Acuity (Investigational vs Air Optix Aqua Lens)|The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.|1 week|All eligible, dispensed eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
1395201|NCT01308918|Secondary|Duration of the Intubating Process|The timer was started when the GLS blade was inserted between the lips and stopped when the proximal part of the tracheal cuff was passed through the vocal cords. When a patient had teeth at the superior jaw, the DLT was first inserted into the mouth prior to the insertion of the GLS blade in order to avoid rupturing the tracheal cuff. For these cases, the timer was started when the DLT was inserted between the lips.|1 hour (Post intubation)||||Seconds||Standard Deviation|Mean
1395202|NCT01308918|Primary|Number of Successfull Primary Placement of the Double Lumen Tube.|To evaluate the number of participants where GlideRite DLT Stylet® associated to the video laryngoscopy (GlideScope®)allowed the primary placement of the double lumen tube into their trachea.|1 hour (Post intubation)||||Participants|||Number
1395203|NCT01308840|Secondary|The Number of Participants Who Experience an Adverse Event|Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event|baseline to study completion||||participants|||Number
1395204|NCT01308840|Secondary|Median Overall Survival|Death from any cause was used.|enrollment until date of death||||months||Full Range|Median
1395205|NCT01308840|Secondary|Median Progression Free Survival|Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|time to cancer progression or death||||months||Full Range|Median
1395206|NCT01308840|Primary|The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.|Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.|end of cycle 2 of treatment||||participants|||Number
1395207|NCT01308814|Secondary|Change in Baroreceptor Sensitivity|"A finometer noninvasive blood pressure devise (FMS) was used to collect a 10 minute recording of beat-to-beat blood pressure and pulse rate during spontaneous breathing under quiet recumbent conditions. baroreflex sensitivity was computed from the most stable 5-minute segment of this 10-minute period. Cross-spectral analysis was used to estimate the average transfer function modulus (i.e., gain) between systemic blood pressure oscillations and R-R interval oscillations in the frequency range of 0.07-0.14 Hz, also known as the low frequency band. The units of this baroreflex sensitivity (BRS) were msec/mmHg.~The outcome presented here is the 12 month BRS minus baseline BRS."|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||msec/mmHg||Standard Deviation|Mean
1395208|NCT01308814|Secondary|Change in Percentage of Brachial Artery Diameter|Change (from Baseline-to-12 Month) in flow mediated dilatation (FMD) test of the brachial artery, dilatation occurs following an acute increase in blood flow, induced by via circulatory arrest in the arm for a period of time. Measured using high resolution ultrasound, yielding a measure of endothelial-dependent vasodilatation. The increase in brachial arterial diameter as a consequence of reactive hyperemia is compared to the baseline diameter of the artery and expressed as a percentage of the baseline diameter (% FMD). Flow-mediated vasodilatation at each time point was calculated as diameter of the brachial artery under reactive hyperemia minus baseline diameter of the brachial artery. The change presented here is calculated as 12 month %FMD minus baseline month %FMD.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||percent flow mediated dilatation||Standard Deviation|Mean
1395209|NCT01308814|Secondary|Percentage Meeting Criteria for Metabolic Risk [Baseline and Month 12]|Subjects will be classified as having metabolic risk if they either meet standard criteria for the metabolic syndrome (based on 3 of 5 risk factors: elevated blood pressure, fasting triglycerides, fasting glucose, waist circumference and low HDL-cholesterol) or they exhibit insulin resistance based on the homeostatic model assessment (HOMA) to derive HOMA-IR based on fasting insulin and glucose levels using the equation: HOMA-IR = fasting glucose (mmol/L) × fasting insulin (μU/mL)/22.5|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||Participants|||Count of Participants
1395210|NCT01308814|Secondary|Change in Functional Well-being as Assessed by the Medical Outcomes Study 36-item Short Form (SF-36)|The Medical Outcomes Study 36-item Short Form (SF-36) is a measure of functional well-being, including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to emotional health problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of this scale is 0-100, where higher scores indicates a more favorable health state.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||units on a scale||Standard Deviation|Mean
1395211|NCT01308814|Primary|Change in Stress Reactivity During Laboratory Session Including Trier Social Stress Test|Primary measures reflecting stress reactivity will consist of mean arterial pressure (MAP), vascular resistance index (VRI), plasma cortisol, and plasma IL-6. For each of these four measures, a delta score (change from rest to stress) will be calculated and then standardized as Z scores. The individual Z scores will then be averaged to yield a single Stress Reactivity profile measure (average z score) - a composite Z score reflecting magnitude of activation in the four primary stress-responsive pathways. This composite z score at baseline will be subtracted from the composite z score at 12 months to yield this outcome measure.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||composite Z score||Standard Deviation|Mean
1395212|NCT01308814|Primary|Change in Psychiatric Diagnosis as Assessed by the Structured Clinical Interview for DSM Disorders I/NP||Baseline and when prompted by CES-D score|These data were not collected because this measure is no longer the preferred method for characterizing change in depression risk. The preferred method is now to measure depressive symptoms continuously, which was done. These continuous results can be found for the CESD score in this record.||||||
1395213|NCT01308814|Primary|Change in Depressive Symptoms as Indicated by The Center for Epidemiologic Studies Depression Scale (CES-D)|Change from pre-trial (baseline) to post-trial (month 12) in the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D has a Range from 0-60, with higher scores indicating the presence of more symptomatology. A score of 16 or greater is indicative of clinically significant symptoms of depression.|Baseline, month 12|The data presented here are based on individuals who completed the study and provided useable data for this particular measure at the time point reported.|||units on a scale||Standard Deviation|Mean
1395214|NCT01308788|Primary|2-year Change in OPP||Baseline and 24 month visits||||mm Hg||Standard Error|Mean
1395215|NCT01308788|Primary|2-year Change in CRA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||unitless||Standard Error|Mean
1395216|NCT01308788|Primary|2-year Change in CRA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
1395217|NCT01308788|Primary|2-year Change in CRA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
1395218|NCT01308788|Primary|2-year Change in OA RI||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||unitless||Standard Error|Mean
1395219|NCT01308788|Primary|2-year Change in OA EDV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
1395220|NCT01308788|Primary|2-year Change in OA PSV||Baseline and 24 month visits|one participant was unable to be measured for this outcome|||cm/sec||Standard Error|Mean
1395221|NCT01308788|Primary|6-month Change in Ocular Perfusion Pressures (OPP)||Baseline and 6 month visits||||mm Hg||Standard Error|Mean
1395222|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)||Baseline and 6 month visits||||unitless||Standard Error|Mean
1395223|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1395224|NCT01308788|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1395225|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)||Baseline and 6 month visits||||unitless||Standard Error|Mean
1395226|NCT01308788|Primary|6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1395227|NCT01308788|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)||Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1395228|NCT01308762|Secondary|Administration Site Reactions|Local skin reactions are viewed as a normal and predicted reaction to exposure to a preparation of mycobacterial antigens. All patients experienced administration site reactions and all reactions were examined and characterised. However only those reported as adverse events are presented here.|Day -3 to Day 56|Safety population|||Participants|||Number
1395229|NCT01308762|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"Safety and tolerability were measured with respect to:~Safety measurements~Local tolerability at the site of intradermal injection~Incidence of adverse events."|56 days|All analyses were based on the safety population, which comprised of all patients who received at least one dose of IMP. Safety measurements and nature and incidence of adverse events were reported for the Safety population|||Participants|||Number
1395230|NCT01308749|Secondary|Mean Change in Temperature During Period 1|Temperature was collected on each participant via oral or temporal thermometer. The mean change in each group was assessed.|Week 0 to 8||||degrees fahrenheit||Standard Error|Mean
1395231|NCT01308749|Secondary|Mean Change in Prolactin Levels Over Period 1|Serum prolactin levels were collected and analyzed in participants|Week 0 to 8||||nanograms per milliliter (ng/mL)||Standard Error|Mean
1395232|NCT01308749|Secondary|Change in Mean Systolic Blood Pressure During Period 1|Change in mean systolic blood pressure during double blind phase|Week 0 to 8|The one subject who discontinued at week 1 did not have follow up data to include in the analysis.|||millimeters of mercury (mmHg)||Standard Error|Mean
1395233|NCT01308749|Secondary|Change in Mean Pervasive Developmental Disorder Behavior Inventory - Screening Version (PDDBI-SV) Total Score Over Both Periods|The PDDBI-SV examines both adaptive and maladaptive behaviors related to autism. It has normative scores for children between 2-11 years. For children 12 years and older, the norms (11 years, 11 months) will be used. Each item is scored on a scale from 0-3. For the first 9 items, the total of individual items is summed. For items 10-18, the scores are reversed and then summed (i.e.: 0=3, 1 =2, 2=2, 3 = 0). Then the total of 0-9 and then the reversed scored items 10-18 are summed for a final total score. Higher scores indicate more impairment. The range of total scores is 0-54. ASD/Social deficits unlikely: 0-6, More information needed/borderline: 7-10, autism spectrum disorder (ASD)/social deficits likely (mild):11-14, ASD/social deficits likely (moderate): 15-29, ASD/social deficits likely (severe): 30-37, ASD/social deficits likely (extreme): 38 or higher.|Baseline to 16 Weeks|used only subjects with all data points no data carried forward|||scores on a scale||Standard Error|Mean
1395234|NCT01308749|Secondary|Change in Mean Aberrant Behavior Checklist (ABC)-Social Withdrawal Subscale Score Over Both Periods|Efficacy measures included the Aberrant Behavior Checklist -Social Withdrawal subscale scor. The ABC which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and lethargy. A modified version of the lethargy subscale was used. Typically the Lethargy subscale includes 16 items, however, for our purposes 3 items that were specifically related to lethargy (i.e.: listlessness) were removed so that the focus could primarily be on aberrant social behavior. Differences in only the Social Withdrawal domain were assessed.The is the sum of items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC- Social Withdrawal total score ranges from 0 to 39. Higher values represent greater severity of illness.|Baseline to 16 Weeks|population of participants with all data available for mixed models analysis no data carried forward|||scores on a scale||Standard Error|Mean
1395442|NCT01306305|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP|||Fold (ratio)|||Number
1395443|NCT01306305|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP|||Number of subjects|||Number
1395235|NCT01308749|Secondary|Change in Mean Autism Diagnostic Observation Schedule (ADOS) Total Score|The ADOS is a semi-structured assessment used to assess and diagnose individuals suspected of having autism of varying ages, developmental levels, and language skills (from no speech to verbally fluent). The ADOS includes four modules, each requiring just 35-40 minutes to administer. The individual being evaluated is given just one of 4 modules, depending on his or her expressive language level and chronological age. The rater will observe social and communication behaviors during various activities in the appropriate module. A rater then uses a 0-3 scale to rate each type of behavior. A select number of individual items will be summed for a total score representing communication and reciprocal social interaction. In scoring all 3's are collapsed to a 2. A higher score indicates more severe impairment. Ranges of scores are as follows: Module 1: 0-24, Module 2: 0-24, Module 3: 0-22, Module 4: 0-22.|Baseline to 16 Weeks|1 patient without post baseline measures is not included|||scores on a scale||Standard Error|Mean
1395236|NCT01308749|Secondary|Change in Mean Total Social Social Responsiveness Scale (SRS) T-score|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The raw score of each individual item is summed to create a total raw score. The total raw score is then translated into a total T-scores (which are the equivalent of standard scores). Total T-scores results are as follows: 59 and below: within normal limits, 60-65: Mild range of impairment 66-75: Moderate range of impairment 76 or higher: Severe range of impairment.|0-8 weeks, blinded treatment, period 1|All participants with at least one post baseline assessment, 1 person from sequence 1 discontinued due to no post baseline measures|||T-scores||Standard Error|Mean
1395237|NCT01308749|Secondary|Change in Mean Weight|changes during period 1|between weeks 0 and 8|The subject who discontinued after 2 days did not have repeat assessments and is excluded from these analyses|||pounds||Standard Error|Mean
1395238|NCT01308749|Secondary|Change in Mean Plasma Oxytocin Level During Period 1 - Double Blind Phase|Blood samples will be collected to obtain proof of concept data regarding changes in afternoon plasma oxytocin levels|Week 0 to week 8|participants with oxytocin plasma levels at baseline and week 8|||picograms/mL (pg/mL)||Standard Deviation|Mean
1395239|NCT01308749|Primary|Number of Participants Who Could Tolerate Twice Daily Oxytocin|This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin.|Week 0 to week 16|all participants who recieved oxytocin at any time|||Participants|||Count of Participants
1395240|NCT01308749|Primary|Number of Participants Who Could Tolerate Twice Daily Oxytocin|This study will help to determine tolerability of intranasal oxytocin treatment in children with autism by measuring the ability of at least 80% of the sample to tolerate twice daily intranasal administration of oxytocin.|Week 0 to week 8|This is over period 1, the double blind phase (week 0 to week 8) only|||Participants|||Count of Participants
1395241|NCT01308736|Primary|Cigarette Reduction|50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.|At 6-month follow-up||||participants|||Number
1395242|NCT01308619|Secondary|Change From Baseline in Clinician's Erythema Assessment (CEA) Scores|Mean change in Clinician's Erythema Assessment (CEA) from baseline to week 12. Clinician's Erythema Assessment evaluates erythema on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Significant and 4 = Severe) with 0 being best and 4 being worst.|baseline to week 12||||units on a scale||Standard Deviation|Mean
1395243|NCT01308619|Secondary|Investigator's Global Assessment (IGA) Scores at Week 12|Number of participants in each category of the Investigator's Global Assessment (IGA) scores at week 12. Investigator's Global Assessment evaluates papules and pustules of rosacea on a scale from 0 - 4 (0 = Clear, 1 = Near Clear, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.|Week 12||||participants|||Number
1395244|NCT01308619|Secondary|Change From Baseline in Biochemical Markers of Rosacea From Tape Stripping and/or Skin Biopsy From Baseline to Week 12|Mean change from baseline to week 12 in biochemical markers of rosacea and expression in skin samples. A biological marker is a substance used as an indicator of a biological state such as rosacea. Biochemical markers are serine protease activity and expression, metalloprotease activity and expression, and production of leucine leucine-37 [LL-37] peptide.|baseline to week 12|Treatment success was defined as all subjects from either treatment group with a score of clear or near clear on the Investigator’s Global Assessment (IGA) scale. Treatment failure was defined as all subjects from either treatment group with a score of mild, moderate, or severe on the IGA scale.|||micr grams protein||Standard Deviation|Mean
1395245|NCT01308619|Primary|Change From Baseline in Inflammatory Lesion Counts|Mean change in inflammatory lesion counts from baseline to week 12|baseline to week 12||||inflammatory lesions||Standard Deviation|Mean
1395246|NCT01308580|Secondary|Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel|Blood samples for PK analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the EOI, 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population. Number of participants analyzed= participants with PK assessment at specified time-points.|||litre||Standard Deviation|Mean
1395247|NCT01308580|Secondary|Plasma Clearance (CL) for Cabazitaxel|Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.|Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI|Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points.|||Litre/hour||Standard Deviation|Mean
1395256|NCT01308580|Secondary|Percentage of Participants With Pain Response|Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in AS, or a ≥50% decrease from baseline mean AS without increase in the PPI score, maintained for 2 consecutive evaluations at least 3 weeks apart. Increases in pain during the first 12 weeks were ignored in determining pain response.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for pain response with pain score with median PPI ≥2 and/or mean AS ≥10 points at baseline and at least one valid post-baseline value.|||percentage of participants||95% Confidence Interval|Number
1395248|NCT01308580|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period. On-treatment period: The time from the first dose of treatment to 30 days after the last dose of treatment (either Cabazitaxel or Prednisone). A serious adverse event: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03 (Grade 3 [severe] and Grade 4 [life-threatening]) was used in this study to grade clinical AEs.|From first administration of study treatment until 30 days after the last administration of study treatment (Maximum duration: 48 months)|Safety population included all randomized participants who received at least one dose of the study drug during study treatment period.|||percentage of participants|||Number
1395249|NCT01308580|Secondary|Time to First Definitive Consumption of Narcotic Medication|Concomitant medications used were recorded for all participants, and time of first definitive consumption of narcotic medication (if it occurred) was determined. This measure summarizes the time from baseline to first definitive consumption of narcotic medication. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
1395250|NCT01308580|Secondary|Time to Definitive Weight Loss by 5% and 10% From Baseline|Time to definitive weight loss was defined as the time to first occurrence of ≥5% or ≥10% decrease in body weight from baseline. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
1395251|NCT01308580|Secondary|Time to Definitive Deterioration of ECOG PS Score From Baseline|The ECOG PS was used to evaluate participant’s DP and the effect of the disease on the participant’s activities of daily living. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for < 50 % of the time; 3= in bed for > 50% of the time; 4= 100% bedridden; 5= dead). Time to definitive deterioration in ECOG PS score from baseline was defined as a change from 0, 1 to ≥2, or from 2 to ≥3. Analysis was performed by Kaplan-Meier method.|From baseline until death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
1395252|NCT01308580|Secondary|Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales|The time to definitive deterioration (10% decrease in score from baseline) was assessed for the individual sub-scales (Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Prostate-Specific Concerns). Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population.|||months||95% Confidence Interval|Median
1395253|NCT01308580|Secondary|Percentage of Participants With FACT-P Total Score Response|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL. Responder of FACT-P was defined as at least one occurrence of 7-point improvement from baseline in FACT-P total score during treatment period.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on FACT-P population. Number of participants analyzed= participants with evaluable FACT-P total score for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
1395254|NCT01308580|Secondary|Change From Baseline in FACT-P:Total Score as a Measure of HRQoL|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P Total Score sums all 5 sub-scales to give a score in the range of 0 to 156, where higher values represent better HRQoL.|Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)|Analysis was performed on FACT-P population. Number of participants analyzed=participants with evaluable FACT-P Total Score for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||95% Confidence Interval|Least Squares Mean
1395255|NCT01308580|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL)|FACT-P is a 39-item participant questionnaire that measures the concerns of participants with prostate cancer. It consists of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P TOI combines physical well-being, functional well-being, and prostate-specific concerns sub-scales for a total possible score range of 0 to 104, where higher values represent better HRQoL.|Baseline, Day 1 of each Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 (each cycle 21-day); post-treatment follow up 1 (up to 12 weeks)|FACT-P population included randomized participants who completed FACT-P questionnaire at baseline & in at least one post-baseline assessment. Number of participants analyzed=participants with evaluable FACT-P TOI for specified outcome measure. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||95% Confidence Interval|Least Squares Mean
1395272|NCT01308567|Secondary|Time to Tumor Progression Free Survival|Time to tumor progression free survival was defined as the time interval between randomization and the date of first occurrence of tumor progression (assessed using RECIST version 1.1) or death, whichever was earlier. Analysis was performed by Kaplan-Meier method.|Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|ITT population included all randomized participants.|||months||95% Confidence Interval|Median
1395257|NCT01308580|Secondary|Time to Pain Progression|Pain Progression was defined as an increase of ≥1 point in the median PPI from its nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean AS compared with the baseline score confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. AS was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.|From baseline until DP, start of another anti-cancer therapy, death or study cut-off date (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
1395258|NCT01308580|Secondary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for PSA response with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value.|||percentage of participants||95% Confidence Interval|Number
1395259|NCT01308580|Secondary|Time to PSA Progression|Time to PSA progression was time interval between randomization & first occurrence of PSA progression. PSA progression defined as: 1) PSA responders (>50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over nadir value, confirmed by second PSA ≥3 weeks later; 2) PSA non-responders (did not achieve >50% decline from baseline PSA ≥10 ng/mL): increase of ≥25% (≥2 ng/mL) over baseline value, confirmed by second PSA ≥3 weeks later; 3) In participants not eligible for PSA response (baseline PSA <10 ng/mL): (a) participants with baseline PSA >0 ng/mL & <10 ng/mL: increase in PSA by 25% (≥2 ng/mL) above baseline level, confirmed by second PSA value ≥3 weeks apart; (b) participants with baseline value=0 ng/mL: post-baseline PSA value ≥2 ng/mL. Note (for 1-3): Rise in PSA in first 12 weeks was progression only if met definition above and was associated with other sign of DP or if it continued beyond 12 weeks. Analysis was performed by Kaplan-Meier method.|From baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
1395260|NCT01308580|Secondary|Percentage of Participants With Overall Objective Tumor Response|Overall objective tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1 criteria, as assessed by the investigator. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population. Number of participants analyzed= participants evaluable for tumor response with measurable disease at baseline and at least one valid post-baseline value.|||percentage of participants||95% Confidence Interval|Number
1395261|NCT01308580|Secondary|Time to Tumor Progression|Time to Tumor progression was defined as the first occurrence of radiological tumor progression according to RECIST 1.1. Radiological tumor progression was defined at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target-lesions. Analysis was performed by Kaplan-Meier method.|From baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
1395262|NCT01308580|Secondary|Progression Free Survival (PFS)|PFS was evaluated from date of randomization to date of first documentation of any of the events: 1) Radiological tumor progression: as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: at least a 20% increase in sum of diameters of target lesions (sum must also demonstrate an absolute increase of ≥5 mm) taking as reference the smallest sum while on study, appearance of one or more new lesions, or unequivocal progression of existing non target lesions, 2) Prostate Specific Antigen (PSA) progression: ≥25% increase over baseline/nadir value if baseline PSA ≥10 ng/mL; or 25% increase above the baseline level if baseline PSA >0 ng/mL & <10 ng/mL; or post-baseline value of >=2 ng/mL, if baseline PSA=0 ng/mL, 3) Pain progression: increase of ≥1 point in median Present Pain Intensity (PPI) from nadir or ≥25% increase in mean analgesic score (AS) from baseline score or requirement of local palliative radiotherapy, 4) Death. Analysis was performed by Kaplan-Meier method.|From baseline up to tumor progression, PSA progression, pain progression, death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
1395263|NCT01308580|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive or the study cut-off date. The cut-off date for the final analysis of OS was the date when the 988th death had been observed. Analysis was performed by Kaplan-Meier method.|From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)|Analysis was performed on Intent-to-Treat (ITT) population, which included all randomized participants.|||months||95% Confidence Interval|Median
1395271|NCT01308567|Secondary|Percentage of Participants With Overall Objective Tumor Response|Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with measurable disease at baseline and at least one valid post-baseline value analyzed for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
1395264|NCT01308567|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL|FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). Physical well being, functional well being, and prostate-specific concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.|Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)|Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains.|||units on a scale||95% Confidence Interval|Least Squares Mean
1395265|NCT01308567|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)|FACT-P was a 39-item participant rated questionnaire that measures the concerns of participants with prostate cancer. It consisted of 5 sub-scales assessing physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and prostate-specific concerns (12 items). FACT-P total score was the sum of all 5 subscale scores. It ranged from 0 to156 with higher score indicated better quality of life with fewer symptoms.|Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks)|Analysis was performed on FACT-P population that included all participants with evaluable individual FACT-P subscale score at baseline and post-baseline on at least 1 of the subscale domains.|||units on a scale||95% Confidence Interval|Least Squares Mean
1395266|NCT01308567|Secondary|Skeletal Related Events (SRE) Free Survival|SRE free survival was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SRE or death due to any cause, whichever was earlier. SRE were assessed by clinical evaluation. Occurrence of SRE was defined as: pathological fracture(s) and/or spinal cord compression; need for bone irradiation, including radioisotopes or bone surgery; and change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the setting of increased pain) to treat bone pain. Analysis was performed by Kaplan-Meier method.|Baseline until occurrence of first SRE or death (maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.|||months||95% Confidence Interval|Median
1395267|NCT01308567|Secondary|Percentage of Participants With Pain Response|Pain response was defined as either a ≥2-point decrease from baseline median PPI score without increase in analgesic score, or a ≥50% decrease in analgesic use from baseline mean analgesic score (only in participants with baseline mean analgesic score≥10) without increase in the pain. Either criterion was maintained for 2 consecutive evaluations at least 3 weeks apart. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points.|Baseline until pain progression, death or study cut-off date (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with pain score with median PPI ≥2 and/or mean analgesic score≥10 points at baseline and at least one valid post-baseline value for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
1395268|NCT01308567|Secondary|Time to Pain Progression Free Survival (Pain PFS)|Time to pain PFS was defined as the time interval between date of randomization and the date of the first occurrence of pain progression or death, whichever was earlier. Pain progression was defined as an increase of ≥1 point in the median present pain intensity (PPI) score from the nadir confirmed by a second assessment at least 3 weeks later or ≥25 % increase in the mean analgesic score from baseline, due to cancer related pain confirmed by a second assessment at least 3 weeks later or requirement for local palliative radiotherapy. PPI was rated by participant in a diary using a scale of 0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible 5=excruciating. Analgesic use was recorded by the participant in a diary. Analgesic score was calculated from the analgesic use data based on a table of analgesic medications, with non-narcotic medications assigned a value of 1 point and narcotic medications assigned a value of 4 points. Analysis was performed by Kaplan-Meier method.|Baseline until disease progression, death or study cut-off date (maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.|||months||95% Confidence Interval|Median
1395269|NCT01308567|Secondary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later in participants with baseline PSA value ≥10 ng/mL.|Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months)|Analysis was performed on ITT population. Number of participants analyzed=participants with PSA value ≥10 ng/mL at baseline and at least one valid post-baseline value for specified outcome measure.|||percentage of participants||95% Confidence Interval|Number
1395270|NCT01308567|Secondary|Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)|Time to PSA-PFS: time interval between date of randomization & first occurrence of PSA progression/ death, whichever was earlier. PSA progression:1) In PSA responders(≥50% decline from baseline PSA of ≥10 ng/mL):increase of ≥25%(at least 2 ng/mL)over nadir value, confirmed by second PSA value at least 3 weeks later;2)In PSA non-responders(not achieved ≥50% decline from baseline PSA ≥10 ng/mL):increase of ≥25% (at least 2 ng/mL) over baseline value, confirmed by second PSA value at least 3 weeks later;3)In participants not eligible for PSA response(baseline PSA <10 ng/mL):(a)in participants with baseline PSA>0 ng/mL&<10 ng/mL: increase in PSA by 25% (at least 2 ng/mL) above baseline level, confirmed by second PSA value at least 3weeks apart;(b)in participants with baseline value=0ng/mL: a post baseline PSA value ≥2ng/mL.Early rise in PSA only indicated progression if it was associated with another sign of DP or if it continued beyond 12 weeks. Analysis performed by Kaplan-Meier method.|Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier ((maximum duration: 51 months)|Analysis was performed on ITT population which included all randomized participants.|||months||95% Confidence Interval|Median
1395273|NCT01308567|Secondary|Progression Free Survival (PFS)|PFS: time interval between date of randomization to date of first occurrence of any of following events: tumor progression according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1; Prostate Specific Antigen (PSA) progression; pain progression or death due to any cause. Analysis was performed by Kaplan-Meier method.|Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months)|ITT population included all randomized participants.|||months||95% Confidence Interval|Median
1395274|NCT01308567|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date if the participant’s last contact was after the cut-off date. The study cut-off date for the final analysis of OS was the date when the 774th death had been observed. Analysis was performed by Kaplan-Meier method.|Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months)|ITT population included all randomized participants.|||months||95% Confidence Interval|Median
1395275|NCT01308476|Secondary|Patients Satisfaction With SMS System|Only patients in the SMS group were asked to assess their satisfaction with the SMS system by assigning German school grades 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=deficient, 6=insufficient.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percantage of participants|||Number
1395276|NCT01308476|Secondary|Physicians Recommendation of the SMS System|Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know)|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percentage of participants|||Number
1395277|NCT01308476|Secondary|Physicians Assessment of Usefulness of the SMS System|Only physicians of patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percentage of participants|||Number
1395278|NCT01308476|Secondary|Patients Assessment of Usefulness of the SMS System|Only patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful.|Visit 2 (12 weeks) and visit 3 (24 weeks)|FAS for SMS reminder group only|||Percentage of participants|||Number
1395279|NCT01308476|Secondary|Patients Compliance With SMS System|Compliance was defined as the percentage of patients answers to the IVR system as compared to the number of SMS automatically sent to the patients by the SMS/ IVR system asking for the number of Spiriva HandiHaler applications.|24 weeks|FAS|||Percentage of participants answers||Standard Deviation|Mean
1395280|NCT01308476|Secondary|Response Rate Regarding Adherence|Adherence was dichotomised into yes and no at the end of study depending on whether the percentage of adherence was at least 80 percent or less than 80 percent, respectively. Patients who did not respond to the SMS/ IVR system to provide information about the actual number of inhalations were considered with 0 percent adherence.|24 weeks|FAS|||Percentage of participants|||Number
1395281|NCT01308476|Secondary|Change From Baseline in Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Week 8, Week 12, Week 16, Week 20 and Week 24|FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis.|||Percent change||Standard Deviation|Mean
1395282|NCT01308476|Primary|Adherence to Spiriva HandiHaler Over Time|Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4.|Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24|"Full Analysis Set (FAS) is defined as all treated patients who additionally met the study diagnosis (Chronic Obstructive Pulmonary Disease (COPD) requiring long-acting anticholinergics) and who had evaluable data in at least one effectiveness endpoint.~Only subjects who responded to the SMS/ IVR system were considered in this analysis."|||Percentage of applications||Standard Deviation|Mean
1395283|NCT01308463|Secondary|Survivorship Will be Measured by the Incidence of Revision or Removals|The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed|10 years Post-op|This analysis cannot be conducted due to the low number of cases available with 10 year data. There is not sufficient data to calculate survivorship. This study is being terminated since the product has been sold to another company.||||Elbows||
1395284|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction|"This is the patient's perception of satisfaction with the elbow replacement surgery.~Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction."|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.|||units on a scale|Elbows|Standard Deviation|Mean
1395285|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Function|This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.|||units on a scale|Elbows|Standard Deviation|Mean
1395286|NCT01308463|Primary|Patient Derived American Shoulder and Elbow Society (ASES) Pain Score|This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)|10 Years Post-op|The number of participants analyzed in this section is reflective of the number of participants/elbows with the complete data required to calculate this score. This is different than the number reflected in participant flow which is indicative of the number of participants/elbows with any data during the given interval.|||units on a scale|Elbows|Standard Deviation|Median
1395287|NCT01308450|Primary|Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test.|"To increase the number of normal Adolescent and Adult tests to the existing Quotient System Database. To assure subjects are normal, participants will complete a standard battery of self assessment questionnaires to screen for the presence of mental health issues including: ADHD, Anxiety Disorder, Depressive Disorder or Bipolar Disorder using the following well established scales and their scoring guidelines:~ADHD Self Rating Scale (ASRS)~Zung Self-Rated Anxiety Scale (SAS)~Zung Self-Rated Depression Scale (SDS)~Mood Disorder Questionnaire (MDQ)~Quotient® ADHD System Test, Adolescent and version Each subject and their individual assessment scores will be evaluated by a physician. Those participants evaluated as normal(without ADHD) will have the results of their Quotient test added to the existing Quotient normative database of Non ADHD subjects."|12 to 18 weeks||||participants|||Number
1395288|NCT01308424|Primary|Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).|Subjects start a daily diary based on start of symptoms of a new emerging cold sore and start taking study medication. Subjects note the start time of study medication along with cold sore stage(s)for at least 7 days and up to 14 days. Subjects take study medication for 7 days. Cold Sore stages are 0=Dormant, 1=Prodrome, 2=Inflammation, 3=Vesicle, 4=Ulcer, 5=Crust, 6=Healed. If subjects do not experience a new cold sore outbreak within 7 days, they do not take study medication and are completed with the study.|7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)|As randomized subjects waited until reoccurrence of cold sore lesions, 23/87 participants in the placebo treatment group and 9/84 in the BTL-TML-HSV group took study medication and were eligible for the primary outcome.|||percentage of Participants|||Number
1395289|NCT01307956|Other Pre-specified|Time to Treatment Failure||From the first date of therapy until the date the patient is removed from study for any reason, assessed up to 5 years|||||||
1395290|NCT01307956|Other Pre-specified|Survival|Descriptively summarized using the method of Kaplan-Meier.|From the first date of therapy until the date the patient dies, assessed up to 5 years|||||||
1395291|NCT01307956|Other Pre-specified|Steady-state Plasma Concentrations of Fluorouracil|Descriptive statistics (means, proportions and 95% confidence intervals) will be used to examine the association of 5-FU and polymorphic variations in genomic DNA with clinical toxicity and response.|Pre-treatment, and at hours 22, 23, 43, and 44 hours during the 46-hr infusion week 1|||||||
1395292|NCT01307956|Other Pre-specified|Progression-free Survival|Descriptively summarized using the method of Kaplan-Meier.|Up to 5 years|||||||
1395293|NCT01307956|Other Pre-specified|Polymorphic Variations in Genomic Deoxyribonucleic Acid (DNA) (Including Thymidylate Synthase, Excision Repair Cross-complementing Rodent Repair Deficiency, Complementation Group 2 [ERCC2]/SPD, RAD51 and Breast Cancer [BRCA]2)||Pre-treatment, and at hours 22, 23, 43, and 44 hours during the 46-hr infusion week 1|||||||
1395294|NCT01307956|Other Pre-specified|Incidence of Adverse Events Graded Using the National Cancer Institute Common Toxicity Criteria Version 3.0||Up to 5 years|||||||
1395295|NCT01307956|Secondary|Proportion of Patients Who Can Undergo Resection|Restaging with repeat imaging studies will be performed. If no contraindication for surgical resection is identified, resection will be performed. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.|4 weeks after completion of the radiation|||||||
1395296|NCT01307956|Primary|Complete Pathological Response (pCR) Rate|Based on the proportion who achieve pCR based on the first 4 courses of protocol treatment. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.|Up to 8 weeks||||Participants|||Count of Participants
1395297|NCT01307891|Secondary|Progression-free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Baseline through 24 months||||months||95% Confidence Interval|Median
1395298|NCT01307891|Secondary|Number of Participants With Serious Adverse Events|Patients will be assessed throughout the study for Grade 4 or 5 toxicities utilizing the Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.|Baseline to 6 months||||Participants|||Count of Participants
1395299|NCT01307891|Primary|Objective Response Rate|Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.|Baseline to 6 months||||percentage of patients||95% Confidence Interval|Number
1395300|NCT01307787|Secondary|Change in Health Status: Social Interaction|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
1395301|NCT01307787|Secondary|Change in Health Status: Psychological Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|analysis per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
1395302|NCT01307787|Secondary|Change in Health Status: Physical Health|Self-reported health status was assessed using the Arthritis Impact-Measurement Scale-2, the Dutch version (Dutch-AIMS2).The questionnaire contains 77 items which represent 5 dimensions: physical functioning, psychological functioning, symptoms, social interaction and role functioning. Responses are recorded on a 5-point scale. All responses were recoded and calculated to a 0-10 scale. Scores were modified according to the number of co-morbidity complaints, as was recommended in the Dutch-AIMS2 manual. A low score indicates better health.|baseline, postintervention at 9 weeks,|per protocol,2 subjects( n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
1395303|NCT01307787|Secondary|Change in Muscle Strength of the Lower Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the knee-flexor and knee-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the lower extremity (LE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol,Lower extremity(LE) muscle strength data for one participant(n=1) in the WLC group is missing because knee problems prevented testing.|||newton||Standard Deviation|Mean
1395304|NCT01307787|Secondary|Change in Muscle Strength of the Upper Extremity|Muscle strength was assessed using a hand-held dynamometer (Microfet, Hoggan health Industries Inc.USA).Maximal voluntary isometric muscle strength of the elbow-flexors, elbow-extensors, was tested and recorded three times for each muscle group. All tests were performed bilaterally. The mean value of three measurements was computed. In addition a sum score of the mean values of the flexors and extensors on both sides for the upper extremity (UE)was computed and taken for analyses.|baseline, postintervention at 9 weeks,|per protocol, one subject (n=1) in the intervention fitprogram withdrew from the study.|||newton||Standard Deviation|Mean
1395305|NCT01307787|Secondary|Change in Self-efficacy Function|Self-efficacy function was assessed by the Arthritis-Self-efficacy Scale Dutch version The subscale self-efficacy function contains 8 items related to physical function. A five-point ordinal scale is used ranging from ‘totally disagree’ (1) to ‘totally agree’ (5). A mean score of 8 items was computed ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|analysis per protocol, 2 subjects(n=2) in the intervention fitprogram withdrew from the study.|||units on a scale||Standard Deviation|Mean
1395306|NCT01307787|Secondary|Change in Self-efficacy Pain and Other Symptoms|Self-efficacy was assessed by the Arthritis-Self-efficacy Scale Dutch version. This arthritis self-efficacy scale contains two sub scales: self-efficacy pain (5 items related to coping with pain, and self-efficacy other symptoms (6 items related to coping with other symptoms, such as depression, fatigue and frustrations.A five-point ordinal scale is used ranging from ‘totally disagree’ (1) to ‘totally agree’ (5). We computed a mean score of 11 items ranging from 1-5. A higher score refers to higher self-efficacy.|baseline, postintervention at 9 weeks,|per protocol 2 subjects( n=2) in the intervention fitprogram withdrew from the study|||units on a scale||Standard Deviation|Mean
1395307|NCT01307787|Primary|Change in VO2 Max, Maximum Oxygen Uptake in ml/Min/kg is the Standard Index of Cardio-respiratory Fitness|maximum oxygen uptake(VO2max, in ml/min/kg)was determined using the Åstrand-Rhyming test.The workload on the cycle ergometer was increased every minute by 25 watts until a steady-state heart rate was achieved. Participants had to sustain cycling for about 6 minutes, the heart rate(HR) was taken every minute. Mean HR of the 5th and 6th minute was registered. With the given workload, observed HR and participants’weight, maximal oxygen uptake can be established using the Åstrand-Rhyming nomogram. Values vary from < 21( sedentary with disease) to > 57 ( very good physical condition).|baseline, postintervention at 9 weeks|Some VO2 max data (n=4 in the intervention group and n=2 in the WLC group)could not be collected because of specific participant conditions at different testing time points. 4 subjects did not reach the necessary heart rate to estimate the VO2 max. One subject had hypertension and one subject had knee problems.|||ml/min/kg||Standard Deviation|Mean
1395308|NCT01307631|Other Pre-specified|Incidence of Adverse Events as Assessed by NCI CTCAE Version 4.0 [Time Frame: Up to 3 Years] [Designated as Safety Issue: Yes]|Data is reported in the Adverse Event table.|3 years|||||||
1395309|NCT01307631|Other Pre-specified|Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 Such as Progression-free Survival and Objective Tumor Response, Assessed by Immunohistochemistry (IHC)||Up to 3 years|||||||
1395310|NCT01307631|Secondary|Duration of Progression-free Survival|Estimated by using Kaplan-Meier analysis.|Up to 3 years||||months||90% Confidence Interval|Median
1395311|NCT01307631|Secondary|Duration of Overall Survival|Estimated by using Kaplan-Meier analysis.|Up to 3 years|Overall survival of all patients on study.|||months||Full Range|Median
1395312|NCT01307631|Primary|Progression-free Survival According to RECIST|Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From start of treatment to time of objective disease progression, assessed up to 6 months|Number of patients who had a PFS > 6 months.|||Participants|||Count of Participants
1395313|NCT01307631|Primary|Objective Tumor Response According to RECIST|Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 months|Number of patients who had an objective response.|||Participants|||Count of Participants
1395419|NCT01306877|Secondary|Overall Quality of Life - General Health Score|Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health|Day 0 minus 60, 1 week, 1 month, 3 months, 6 months||||units on a scale||Standard Deviation|Mean
1395314|NCT01307618|Secondary|Gene Expression Profiles|Gene cluster analysis will be performed using deoxyribonucleic acid (DNA)-Chip Analyzer (dCHIP) software and comparisons will be made before and after treatment in each individual patient, and between responders and non-responders. Attempts will be made to identify gene expression profiles that correlate with clinical outcome.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and gene expression profiles was not measured.||||||
1395315|NCT01307618|Secondary|Overall Survival Assessed by Modified WHO Criteria|Median overall survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.|Up to 4 years||||days||95% Confidence Interval|Median
1395316|NCT01307618|Secondary|Progression-free Survival Assessed by Modified World Health Organization (WHO) Criteria|"Median progression-free survival and the associated 95% confidence limits will be derived using the procedure described in Brookmeyer and Crowley.~The criteria for progressive disease are 1) appearance of new lesions, 2) 25% increase in the sum of the product of the largest perpendicular diameters of the indicator lesions, or 3) reappearance of any tumor."|Up to 4 years||||days||95% Confidence Interval|Median
1395317|NCT01307618|Primary|Type and Grade of Toxicity Incidents Assessed by Common Toxicity Criteria Version 4.0 (CTCAE v4.0)||Up to 4 years|Patients who experienced any adverse event were counted.|||participants|||Number
1395318|NCT01307618|Primary|Absolute Number of CD4+CD25+FoxP3+ Regulatory T Cells From Peripheral Blood|Descriptive statistics and paired t-tests will be generated to describe the frequency and absolute number of CD4+CD25+FoxP3+ cells before and after daclizumab, and also at subsequent time points. Repeated measures of analysis of variance and mixed effects models will be used to further evaluate change in numbers over time, and to compare these changes between cohorts.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and absolute number of CD4+CD25+FoxP3+Regulatory T Cells from peripheral blood was not measured.||||||
1395319|NCT01307618|Primary|Frequency of Vaccine-induced CD8+ T Cells Assessed by Enzyme-linked Immunospot (ELISPOT)|Data before treatment and after 3 vaccines will be assessed using paired t-tests within each cohort as well as a two-sample t-test of the mean post-treatment levels between cohorts. Repeated measures analysis of variance or mixed effects models will be utilized to further characterize changes in the levels of circulating T cells over time.|Up to 4 years|Due to lack of clinical efficacy and lack of drug supply, trial was closed early and frequency of vaccine-induced CD8+T cells was not measured.||||||
1395320|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale|Lee symptom scale (LSS) has subscales with min=0, max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a negative change is correlated with improvement in clinical outcome.|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
1395321|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)|"HAP subscales have min=0 and max=94; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.~Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs.~Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities.~Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78."|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
1395322|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)|"FACT-BMT subscales have various min/max, see below; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.~FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)"|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
1395323|NCT01307462|Secondary|Changes in Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)|SF-36 subscales have min=0 and max=100; results are given as change in 6mo score compared to baseline score, not actual score, and a positive change is correlated with improvement in clinical outcome.|Baseline and 6 months|24 of 36 subjects were evaluable at 6mo due to missing patient survey data.|||units on a scale||Full Range|Median
1395324|NCT01307462|Secondary|Number of Subjects Were Able to Reduce Their Systemic Steroid Exposure by >=50%||Baseline to 6 months|24 out of 36 subjects were evaluable at 6mo due to missing data.|||Participants|||Count of Participants
1395325|NCT01307462|Secondary|Number of Subjects With Improvements in Other Chronic GVHD Characteristics|Only includes subjects who had complete or partial response according to the National Institute of Health (NIH) consensus criteria.|Baseline and 3 months|33 of 36 participants were evaluable at 3 months due to missing provider survey data|||Participants|||Count of Participants
1395326|NCT01307462|Secondary|Changes in Blood Molecular Markers: IL8 (Azithromycin), Cysteinyl and LTB4 (Monteleukast), and IL1B, TNF, and IL6, as Well as Neutrophil Count (Fluticasone)||Baseline to 6 months|Data were not collected||||||
1395327|NCT01307462|Secondary|Number of Subjects Who Experienced Statistically Significant Changes in FVC, TLC, RV, DLCO||Baseline and 6 months||||Participants|||Count of Participants
1395328|NCT01307462|Secondary|Number of Subjects Who Experienced Grade 3-5 SAEs Attributable to FAM and Number of Subjects Who Stopped FAM as a Result|National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) (v4.0)|From baseline to 6 months||||Participants|||Count of Participants
1395329|NCT01307462|Primary|Number of Subjects Who Failed Treatment|Treatment failure is defined as sustained, absolute decrease (worsening) of the FEV1 by >= 10% predicted in comparison to the baseline FEV1. Must be confirmed by a second PFT 2 weeks after the first measurement.|Within 3 months after initiation of study medications||||Participants|||Count of Participants
1395330|NCT01307423|Secondary|Number of Participants With Adverse Events||Up to 5 years||2018-06-30|06/2018||||
1395331|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395332|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose MASES Improves From Baseline to 0 at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval was based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395333|NCT01307423|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 70% improvement in 78 tender joint count; ≥ 70% improvement in 76 swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395334|NCT01307423|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 50% improvement in 78 tender joint count; ≥ 50% improvement in 76 swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395335|NCT01307423|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject’s DAS28 as the measure of severity of disease. A Good response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method|Baseline and Week 52||2018-06-30|06/2018||||
1395336|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves From Baseline by ≥ 1 at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395337|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395338|NCT01307423|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52||2018-06-30|06/2018||||
1395339|NCT01307423|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52||2018-06-30|06/2018||||
1395420|NCT01306877|Secondary|Post-Operative Pain (Analgesic Intake)|post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.|Day 0, 1 week, 2 week, 1 month, 3 month, 6 month||||participants|||Number
1395340|NCT01307423|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52||2018-06-30|06/2018||||
1395341|NCT01307423|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present|Baseline and Week 52||2018-06-30|06/2018||||
1395342|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52||2018-06-30|06/2018||||
1395343|NCT01307423|Secondary|Change From Baseline in the Participants Assessment of Pain Using the Visual Analog Scale at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52||2018-06-30|06/2018||||
1395344|NCT01307423|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Measure Description: Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395345|NCT01307423|Secondary|Change From Baseline in the SF-36v2 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52||2018-06-30|06/2018||||
1395346|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52||2018-06-30|06/2018||||
1395347|NCT01307423|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 20% improvement in 78 tender joint count; ≥ 20% improvement in 76 swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52||2018-06-30|06/2018||||
1395348|NCT01307423|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395421|NCT01306877|Secondary|Post Operative Pain - (PI-NIRS)|"Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain.~The data represented is the change in baseline score at the different timepoints."|Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180||||units on a scale||Standard Deviation|Mean
1395349|NCT01307423|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment.~The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395350|NCT01307423|Secondary|Percentage of Participants With Pre-existing Dactylitis Whose Dactylitis Severity Score Improves to 0 at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395351|NCT01307423|Secondary|Percentage of Participants With Pre-existing Enthesopathy Whose Maastricht Ankylosing Spondylitis Entheses Score Improves to 0 at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395352|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395353|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395354|NCT01307423|Secondary|Percentage of Participants With a ACR 70 Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 78 tender joint count;~≥ 70% improvement in 76 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395355|NCT01307423|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 78 tender joint count;~≥ 50% improvement in 76 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||Percentage of participants|||Number
1395356|NCT01307423|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|"The EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on th DAS-28.~Good or moderate response is defined as follows:~Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or,~an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395357|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395358|NCT01307423|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395359|NCT01307423|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|"The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject’s DAS28 as the measure of severity of disease. Good or moderate response is defined as follows:~Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395360|NCT01307423|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|"Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment.~Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present."|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395361|NCT01307423|Secondary|Percentage of Participants With ≥ 20% Improvement in Maastricht Ankylosing Spondylitis Entheses Score at Week 16|"Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395362|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1395422|NCT01306877|Primary|Intraoperative Bleeding|Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.|Day 0 - time of surgery||||participants|||Number
1395363|NCT01307423|Secondary|Change in Disease Activity Score (DAS 28) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1395364|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16|||units on a scale||Standard Error|Least Squares Mean
1395365|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1395366|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1395367|NCT01307423|Secondary|Change From Baseline in Participants Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
1395368|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16, or who did not have sufficient data for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395369|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1395423|NCT01306643|Secondary|Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
1395370|NCT01307423|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1395371|NCT01307423|Secondary|Change in Baseline in the Disease Activity Score (DAS28) After 16 Weeks of Treatment|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1395372|NCT01307423|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.~The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1395373|NCT01307423|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline to Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1395374|NCT01307423|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|"The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone):~1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Achilles tendon left/right.~The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses."|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1395375|NCT01307423|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
1395376|NCT01307423|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|"Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures:~78 tender joint count,~76 swollen joint count,~Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0=lowest disease activity and 100=highest;~Physician global assessment of disease activity, measured on a 100 mm VAS, where 0=lowest disease activity and 100=highest.~Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395377|NCT01307423|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). SF-36 domain scores were first calculated to range from 0 to100 and then transformed to norm-based scores (the norm-based scores in the US general population have an average of 50 and a standard deviation of 10). Norm-based scores were used in analyses, with higher scores indicating a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1395424|NCT01306643|Secondary|Changes in Concentration of Peripheral Blood Chemokines and Cytokines||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
1395378|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16|||units on a scale||Standard Error|Least Squares Mean
1395379|NCT01307423|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); C-Reactive Protein."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1395380|NCT01307423|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index [HAQ-DI]) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative changes from baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1395381|NCT01307423|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; one participant randomized in error and not receiving any dose of investigational product was excluded. Participants who withdrew early or did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1395382|NCT01307397|Secondary|Overall Survival (OS)|Overall Survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.|Baseline until death (maximum up to 46 months)|Safety population|||Months||95% Confidence Interval|Median
1395383|NCT01307397|Secondary|Percentage of Participants Who Died||Baseline until death (maximum up to 46 months)|Safety population|||Percentage of participants|||Number
1395384|NCT01307397|Secondary|Progression Free Survival (PFS)|PFS was defined as the time between the date of the first treatment and the date of first progression or death from any cause. PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.|Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population|||Months||95% Confidence Interval|Median
1395385|NCT01307397|Secondary|Percentage of Participants With PD Assessed According to RECIST v1.1 or Death|PD was assessed according to RECIST v1.1. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.|Baseline until PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population|||Percentage of Participants|||Number
1395386|NCT01307397|Secondary|Time to Response|Time to response was defined as the time between the date of first treatment and date of first confirmed CR or PR (assessed as per RECIST v1.1). CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response.|Baseline until first documentation of confirmed CR or PR, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population. Number of participants analyzed = participants with measurable disease at baseline.|||Months||Full Range|Median
1395425|NCT01306643|Secondary|Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
1395387|NCT01307397|Secondary|Duration of Response|The duration of response was defined as the time between the date of first confirmed CR or PR and date of first progression of disease (PD), or death, from any cause. Responses were assessed as per RECIST v1.1. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to < 10 mm in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions. Confirmed responses were those that persisted on repeat imaging >= 4 weeks after initial response. PD: at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesion.|From 1st documentation of confirmed CR or PR to PD or death, whichever occurred first (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until end of the study [up to 46 months])|Safety population. Number of participants analysed=participants who achieved CR or PR.|||Months||95% Confidence Interval|Median
1395388|NCT01307397|Secondary|Percentage of Participants With Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR), as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|"BOR was assessed by the investigator according to RECIST v1.1. BOR was defined as having confirmed CR or PR. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; PR: at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions.~Confirmed responses were those that persisted on repeat imaging greater than or equal to (>=) 4 weeks after initial response."|Baseline until first documentation of confirmed CR or PR (assessed at baseline, at Weeks 8, 16, as per institution standard of care thereafter but a minimum every 16 weeks thereafter until the end of the study [up to 46 months])|Safety population. Number of participants analyzed = participants with measurable disease at baseline.|||Percentage of Participants||95% Confidence Interval|Number
1395389|NCT01307397|Secondary|Percentage of Participants Who Received Any Concomitant Medications|Concomitant medications were all medications taken during the study, including those started before but ongoing at first dose. No medications for Melanoma were included. Percentage of participants who received at least one concomitant medication was reported.|Baseline up to 46 months|Safety population|||Percentage of Participants|||Number
1395390|NCT01307397|Secondary|Percentage of Participants With Improvement in Eastern Cooperative Group (ECOG) Performance Status|ECOG Performance Status was measured on-therapy assessed participant's performance status on 5 point scale: 0 = fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Percentage of participants who had at least one point improvement from baseline at any assessment visit as well as at last study visit was reported.|Baseline, Day 1 of each 28 day cycle up to end of treatment (up to 46 months)|Safety population|||Percentage of Participants|||Number
1395391|NCT01307397|Primary|Dose Intensity of Vemurafenib|Dose intensity was defined as (total actual doses taken/total planned doses) *100, where total planned doses = prescribed doses * planned days on treatment, where planned days on treatment were defined as the interval between date of first dose and date of last dose.|Baseline up to end of treatment or death (maximum upto 46 months)|Safety Population|||Percentage of planned dose||Standard Deviation|Mean
1395392|NCT01307397|Primary|Mean Total Vemurafenib Dose Per Day|"Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.~Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation. Average total dose per day: total actual dose taken divided by total actual days on treatment."|Baseline up to end of treatment or death (maximum up to 46 months)|Safety population|||Grams||Standard Deviation|Mean
1395393|NCT01307397|Primary|Duration of Vemurafenib Treatment|"Exposure excluding treatment interruptions: Duration during which participants actually took vemurafenib. Any time without dose-taken due to adverse events, non-compliance or any other reasons was not counted.~Exposure including treatment interruptions: date of last dose - date of first dose + 1; duration during which participants actually took vemurafenib as well as duration on which medication was not taken were included in this calculation."|Baseline up to end of treatment or death (maximum upto 46 months)|Safety population|||Months||Standard Deviation|Mean
1395394|NCT01307397|Primary|Mean Cumulative Dose of Vemurafenib||Baseline up to end of treatment or death (maximum up to 46 months)|Safety population|||Grams||Standard Deviation|Mean
1395395|NCT01307397|Primary|Percentage of Participants With AEs of Special Interest|AEs of special interest included cutaneous squamous cell carcinoma (SCC), rash, photosensitivity, liver injury, arthralgia, fatigue, gastrointestinal (GI) polyps, pancreatitis, potentiation of radiation toxicity, prolongation of cardiac repolarization or arrhythmia, non-cutaneous SCC and other primary malignancies (other than cutaneous SCC or new primary melanoma).|Baseline up to 28 days post end of treatment (maximum up to 46 months)|Safety population|||Percentage of participants|||Number
1395396|NCT01307397|Primary|Percentage of Participants With at Least 1 AE Leading to Study Drug Interruption or Drug Discontinuation|An AE was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Pre existing conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Percentage of participants with dose interruption or discontinuation due to AE was presented.|Baseline up to 28 days post end of treatment (maximum up to 46 months)|Safety population|||Percentage of participants|||Number
1395426|NCT01306643|Secondary|Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells||Up to twelve 28-day cycles (maximum of 12 months)|Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.||||||
1395397|NCT01307397|Primary|Percentage of Participants Experiencing Any Grade 3 or 4 Adverse Events (AEs) as Determined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0|"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the NCI-CTCAE version 4.0, where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows: Grade 3 means Severe; Inability to work or perform normal daily activity; treatment or medical intervention is indicated in order to improve the overall well-being or symptoms; delaying the onset of treatment is not putting the survival of the participant at direct risk. Grade 4 means Life-threatening, Disabling; based on extreme limitation in activity; significant medical intervention/therapy required; and hospitalization probable."|Baseline up to 28 days post end of treatment (maximum up to 46 months)|Safety population. Number of participants analyzed = participants with measurable disease at baseline|||Percentage of participants|||Number
1395398|NCT01307319|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1395399|NCT01307319|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15|The intent to treat (ITT) population included all randomized participants who received at least one dose of randomized study medication and had at least one post-baseline assessment. Two enrolled participants were excluded. One was randomized in error and did not receive test medication. The other provided no post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1395400|NCT01307111|Primary|Patient Perceived Pain on a 100-point Visual Analogue Scale.|Perceived pain was registered on a 100-point visual analogue scale (0 = no pain, 100 = worst pain imaginable) at three time points: prior to IUD insertion, immediately after insertion, and prior to clinic discharge.|Prior to insertion, immediately after insertion, and prior to clinic discharge.||||units on a scale||Standard Deviation|Mean
1395401|NCT01307111|Secondary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale.|Perceived ease of IUD insertion registered on a visual analogue scale (0 = easy, 100 = extremely difficult).|Immediately post IUD insertion||||units on a scale||Standard Deviation|Mean
1395402|NCT01307046|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)||8 weeks|All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
1395403|NCT01307046|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) Population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"|||mmHg||95% Confidence Interval|Least Squares Mean
1395404|NCT01307046|Primary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).|Baseline and Week 8|"Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent~to at least one dose of study treatment, and had baseline data for those analyses that required baseline data"|||mmHg||95% Confidence Interval|Least Squares Mean
1395405|NCT01307033|Primary|Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)||Up to 52 weeks|All-Patients-as-Treated (APaT) Population, which consists of all randomized patients who received at least one dose of MK-0954A. The L100/H12.5 (L50/H12.5) arm only includes data from extension period (44 weeks); L100/H12.5→L100/H12.5 Open Label arm includes data from entire study period (52 weeks).|||Percentage of Participants|||Number
1395440|NCT01306617|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of detection (< 15 IU/mL).|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1395406|NCT01307033|Secondary|Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
1395407|NCT01307033|Secondary|Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8|Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.|Baseline and Week 8 (End of Double-blind Period)|Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
1395408|NCT01307020|Secondary|Percentage of Patients Using Rescue Medication at 6 Hours|Percentage of patients using rescue medication at 6 hours post-dosing.|Baseline to 6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment|||percentage of patients|||Number
1395409|NCT01307020|Secondary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %|4, 8 and 12 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment|||percentage of patient|||Number
1395410|NCT01307020|Primary|Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.|Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %|6 hours|ITT (intention to treat) population which was defined as all patients who have taken the study treatment and have at least 1 post-dose assessment|||percentage of patients|||Number
1395411|NCT01307007|Primary|Changes in Blood Markers|Changes in blood markers of phosphate|Day 35||||mg/dL||Standard Deviation|Mean
1395412|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.|||units on a scale||Standard Deviation|Mean
1395413|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.|||units on a scale||Standard Deviation|Mean
1395414|NCT01306968|Primary|Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat|Means for the change from baseline to follow-up visit 2|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
1395415|NCT01306968|Primary|Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat|The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical outcome measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature.|Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2|Intent to treat population: All randomized participants were included in the intention-to-treat analysis.|||units on a scale||Standard Deviation|Mean
1395416|NCT01306877|Secondary|Operative Room (OR) Time|Time of insertion of anoscope to time of anoscope removal after stapleline evaluation|Day 0||||minutes||Standard Deviation|Mean
1395417|NCT01306877|Secondary|Length of Stay|Length of hospital stay is defined as time of anoscope insertion until discharge|Day 0 time of discharge minus time of admission||||Hours||Standard Deviation|Mean
1395418|NCT01306877|Secondary|Location of the Staple Line|Distance of staple line to dentate line as measure by surgical ruler|Day 0||||mm||Standard Deviation|Mean
1395427|NCT01306643|Primary|Clinical Response: Overall Response Rate|"Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.~Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.~CR was defined as the disappearance of all evidence of disease.~PR was defined the regression of measurable disease and no new sites."|Up to twelve 28-day cycles (maximum of 12 months)|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1395428|NCT01306643|Primary|Overall Safety of Idelalisib|The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).|30 days post last study treatment (up to 12 months)|Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.|||percentage of participants|||Number
1395429|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
1395430|NCT01306617|Secondary|Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
1395431|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
1395432|NCT01306617|Secondary|Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants|Trough concentration (C trough) is the concentration 24 hours after once daily (QD) dose and 12 hours after twice daily (BID) dose.|Day 1 to Week 12|Pharmacokinetic analyses included all participants who received at least 1 dose of the study drug (ITT) and for whom concentration data was available to characterize C trough.|||nanograms (ng) per milliliter (mL)||Full Range|Geometric Mean
1395433|NCT01306617|Secondary|Resistance-Associated Variants and Phenotypic Resistance|Baseline samples were analyzed for resistance-associated amino acid variants using population sequencing. Phenotypic resistance to ABT-450 or ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Participants not achieving SVR12 were analyzed for resistance-associated variants at the time of failure using population sequencing and were compared with the baseline and appropriate reference sequences to assess amino acid changes. Phenotypic resistance to ABT-450 or ABT-333 at the time of failure was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at baseline and at the time of failure are presented.|Day 1 to post-treatment week 48|Resistance analyses included all participants who receive at least one dose of study drug (intent-to-treat [ITT] population).|||participants|||Number
1395434|NCT01306617|Secondary|Time to Virologic Relapse Post-treatment|Time to the first of 2 consecutive measurements of confirmed HCV RNA ≥ lower limit of quantitation (LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to post-treatment week 48|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||days||Standard Error|Mean
1395435|NCT01306617|Secondary|Time to Failure to Suppress or Rebound During Treatment|Time to failure to achieve a 2 log10 IU/mL HCV RNA decrease at Week 1, failure to achieve HCV RNA < Lower Limit of Detection (LLOD) at Week 6, or a confirmed increase of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of quantitation (LLOQ) for participants who previously achieved HCV RNA < LLOQ.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||days||Standard Error|Mean
1395436|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained virologic response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1395437|NCT01306617|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained virologic response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1395438|NCT01306617|Secondary|Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1395439|NCT01306617|Secondary|Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1395444|NCT01306305|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Days 8, 15 and 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination.|Days 1 to 4 inclusive, and Days 8, 15 and 22|Safety population includes all subjects who received study vaccine|||Subjects|||Number
1395445|NCT01306305|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject lost to follow up and one subject who withdrew consent|||Number of subjects|||Number
1395446|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Pulmonary Vascular Resistance (Dyne*Sec/cm^5) - Mean Change From Baseline|All subjects in this study were to have pulmonary vascular resistance (PVR; measured in dyne x seconds per centimeters to the 5th power) derived from mean PAP (measured in mmHg), pulmonary capillary wedge pressure (PCWP [mmHg]) and cardiac output (Qp [litres per minute]), each taken 5 minutes prior to the first investigational product administration, calculated using the following formula: [(mean PAP-PCWP) divided by Qp] x 80. Baseline is the last measurement prior to first investigational product administration, therefore, applying to both products. Mean PAP, PCWP and Qp were repeated at 1 and 10 minutes post dose; PVR was calculated.|Comparison to baseline to 2 post dose timepoints (1 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).|||dyne*sec/cm^5||Standard Deviation|Mean
1395447|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Diastolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|All subjects in this study were to have diastolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in diastolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).|||mmHg||Standard Deviation|Mean
1395448|NCT01306292|Primary|Effects of SonoVue and Placebo on Pulmonary Hemodynamics: Systolic Pulmonary Artery Pressure (mmHg) - Mean Change From Baseline|A total of 36 subjects were enrolled in this crossover study: 18 (8 randomized to placebo then SonoVue and 10 randomized to SonoVue then placebo) in the Hypertension Group (baseline mean pulmonary artery pressure (PAP) >=25.0 mmHg group) and 18 (10 randomized to placebo then SonoVue and 8 randomized to SonoVue then placebo) in the Normal group (baseline mean PAP <25.0 mmHg group). All subjects in this study were to have systolic PAP recorded within 5 minutes before the first investigational product administration. This parameter was to be measured and recorded again at 1, 4, 7 and 10 minutes after the administration of each investigational product (SonoVue and Placebo). This outcome measure presents the mean change from baseline in systolic PAP measured in mmHg. Baseline is the average of the 2 measurements within 5 minutes prior to first investigational product administration, therefore, applying to both products.|Comparison to baseline to 4 post dose timepoints (1, 4, 7 and 10 minutes post dose)|36 total subjects: 18 subjects (8 assigned to placebo/SonoVue and 10 assigned to SonoVue/placebo) in the Baseline mean PAP >=25.0 mmHg group (Hypertension Group) and 18 subjects (10 assigned to placebo/SonoVue and 8 assigned to SonoVue/placebo) in the Baseline mean PAP <25.0 mmHg group (Normal Group).|||mmHg||Standard Deviation|Mean
1395449|NCT01306253|Secondary|Numbers of Subjects Reporting Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population|||Subjects|||Number
1395450|NCT01306253|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP|||Fold (ratio)|||Number
1395451|NCT01306253|Primary|Seroprotection|Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP|||Number of subjects|||Number
1395452|NCT01306253|Secondary|Safety: Numbers of Subjects Reporting Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine|||Subjects|||Number
1395453|NCT01306253|Primary|Seroconversion|Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations excludes one subject per group lost to follow up|||Number of subjects|||Number
1395454|NCT01306214|Secondary|Change From Baseline in HbA1c After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)|||percentage of HbA1c||Standard Error|Least Squares Mean
1395455|NCT01306214|Secondary|Change From Baseline in Body Weight After 52 Weeks of Treatment|The secondary endpoint was the change from baseline in body weight after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set (PPS) - completers at week 52 - using LOCF at week 52 (LOCF-52)|||kg||Standard Error|Least Squares Mean
1395456|NCT01306214|Secondary|Change From Baseline in Insulin Dose After 52 Weeks of Treatment|The secondary endpoint is change from baseline in insulin dose after 52 weeks of treatment|Baseline and 52 weeks|Per Protocol Set-patients in FAS without important protocol violations leading to exclusion, completed minimum treatment of 357 days and did not prematurely discontinue. Values after start of antidiabetic rescue therapy (week 52 definition) were set to missing and last observation carried forward (LOCF-52) was used for imputation of missing values.|||IU/day||Standard Error|Least Squares Mean
1395457|NCT01306214|Primary|Change From Baseline in HbA1c After 18 Weeks of Treatment|The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.|Baseline and 18 weeks|The analysis was conducted on the full analysis set (FAS) of patients. Values after start of antidiabetic rescue therapy (week 18 definition) were set to missing and last observation carried forward (LOCF-18) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Least Squares Mean
1395458|NCT01306201|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation.||Overall average||||Breaths Per Minute (BrPM)||Standard Deviation|Mean
1395459|NCT01306201|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.~The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average for 30 minutes||||Breaths Per Minute (BrPM)|||Number
1395460|NCT01306201|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.|Participants were monitored for average of 30 minutes|10 participants were excluded from data analysis due to following reasons: unreadable files,arrhythmia,electronic data files coud not be processed|||BrPM (Breaths Per Minute)||Standard Deviation|Mean
1395461|NCT01306175|Secondary|Digoxin: Area Under the Curve 0 to Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to the time of the last quantifiable data point.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1395462|NCT01306175|Primary|Digoxin: Maximum Measured Concentration (Cmax)|Maximum measured concentration of digoxin, per period.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1395463|NCT01306175|Primary|Digoxin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity.|1.5 hours (h) prior to the first dose and 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h after the first dose|Pharmacokinetic (PK) set comprised all evaluable subjects who took at least 1 dose of study medication with at least 1 observation for at least 1 primary PK endpoint without any important protocol violations relevant to the PK evaluation. One subject was excluded from the PK set because the pre-dose plasma concentration of digoxin was >5% of Cmax.|||ng-h/mL||Geometric Coefficient of Variation|Geometric Mean
1395464|NCT01306162|Secondary|Free Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of free dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1395465|NCT01306162|Secondary|Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1395466|NCT01306162|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1395467|NCT01306162|Primary|Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.|1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|Pharmacokinetic (PK) set defined as all subjects randomised, treated and who provided evaluable data for at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1395468|NCT01306058|Secondary|Percentage Signal Change in Response on Magnetic Resonance Imaging (MRI)|The perfusion of tumors was evaluated and analysis of normalized signal intensity in unenhanced and enhanced MRIs at each time point with calculation of measured percentage of signal change to reflect tumor vascularity. Signal change and signal intensity is defined as the Initial Area Under the Gd Curve measured over 60 seconds (IAUC60) and the Transport Constant (Ktrans) and the difference in these values relative to baseline.|Baseline and Cycle 1 Day 2 and Cycle 2 Day 1, an average of 12 weeks|This analysis was not done as magnetic resonance imaging (MRI) scans not performed as planned.||||||
1395582|NCT01305200|Secondary|Duration of Total Parenteral Nutrition (TPN) Administration.|Mean days of total parenteral nutrition (TPN) administration.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||Number of days||Standard Deviation|Mean
1395469|NCT01306058|Secondary|Changes in Biomarker Cluster of Differentiation 105 (CD105)|Blood samples were collected and analyzed by the enzyme-linked immunosorbent assay (ELISA). Serum samples were measured using a validated ELISA with a lower limit of quantification (LLOQ) of 200 ng/ml. Soluble endoglin was only assessed in patient samples without detectable TRC105 concentrations.|Cycle 1 day 1, cycle 1 day 15, cycle 2 day 1, or end of study (eos), an average of 12 weeks|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||ng/ml||Inter-Quartile Range|Median
1395470|NCT01306058|Secondary|Changes in Biomarkers Vascular Endothelial Growth Factor (VEGF) and Placenta Growth Factor (PIGF)|Plasma biomarker tests were performed for VEGF and PIGF using assay plates from Meso-Scale Discovery according to the product manual. The concentrations of the cytokines were determined with recombinant standards. Changes in biomarkers were determined by a Wilcoxon signed rank test.|Cycle 1 day 1, cycle 1 day 15, cycle 2 day 1, or end of study, an average of 12 weeks|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||pg/ml||Inter-Quartile Range|Median
1395471|NCT01306058|Secondary|Area Under the Plasma Concentration|Mean peak TRC105 serum trough concentrations were plotted over time by dose level to assess accumulation. (e.g. drug absorption). The lower limit of quantification (LLOQ) is 200 ng/mL.|Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, and prior to start of TRC105 infusion|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Hr*ng/mL||Full Range|Mean
1395472|NCT01306058|Secondary|Number of Participants With Stable Disease, Partial Response, and Progressive Disease on Phase I and Phase II of the Clinical Trial|Response is defined as per the Response Evaluation Criteria in Solid Tumors (RECIST). Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. To be assigned a confirmed PR, changes in tumor measurements must be confirmed by repeat assessments that should be performed at least 4 weeks after the criteria for response are first met. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|Every 8 weeks, up to 180 days|7/27 participants were not evaluable (1 was not evaluable, 1 patient had dose limiting toxicity myocardial infarction, 1 could not tolerate sorafenib, 1 infusion reaction to TRC105 during first dose, 1 early progressive disease, 1 side effects, and 1 off due to severe skin toxicity).|||Participants|||Count of Participants
1395473|NCT01306058|Secondary|Percentage of Participants With Overall Survival (OS) at 6 and 12 Months|Percentage of participants last known to be alive at 6 and 12 months.|6 and 12 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
1395474|NCT01306058|Secondary|Median Overall Survival (OS)|OS was calculated from the on-study date until the date of death or the date the patient was last known to be alive. Probabilities were determined using the Kaplan-Meier method.|up to 2 years|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Months||95% Confidence Interval|Median
1395475|NCT01306058|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 3 and 6 Months|Percentage of participants who were progression free at 3 and 6 months. Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|3 and 6 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
1395476|NCT01306058|Secondary|Median Progression-free Survival (PFS)|PFS was calculated from the on-study date until date of progression, death, or an event that would render the patient inevaluable for further follow-up (liver dysfunction), or end of study. Probabilities were determined using the Kaplan-Meier method. Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|up to 6 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Months||95% Confidence Interval|Median
1395477|NCT01306058|Secondary|Treatment-emergent Adverse Events|Here are the number of treatment-emergent adverse events categorized by Any grade, Grade 3, Grade 4 and Grade 5 adverse events. Adverse events was assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. Grade 1 is mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 is moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (e.g. preparing meals, shopping for groceries or clothes). Grade 3 is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL (e.g. bathing, dressing and undressing). Grade 4 is life-threatening consequences; urgent intervention indicated. Grade 5 is death related to adverse event.|4 years and 10.5 months|25/27 analyzed. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||treatment-emergent adverse events|||Number
1395487|NCT01306032|Secondary|Change in ϓH2AX- Positive Circulating Tumor Cells (CTCs) in Whole Blood|Number of CTCs (evaluable defined as ≥ 6 CTCs) were measured in whole blood during the course of treatment to determine drug-induced deoxyribonucleic acid damage in tumor cells.|At baseline (t=0h) and 24h post drug administration (t=24h)|Patients with sufficient CTC counts (defined as ≥6 total CTCs) pre- and post-drug administration were analyzed.|||ϓH2AX- Positive CTCs||Full Range|Mean
1395478|NCT01306058|Secondary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT was assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. DLT criteria included treatment-related grade 3 non-hematological toxicities or grade 4 hematological toxicities occurring within the first 28 days of treatment. Grade 3 electrolyte toxicities to be corrected to Grade 1 or less within 24 hours will be considered dose limiting (proteinuria >3.5g/24 hour will be defined as a DLT). Drug-related Grade 4 hematological toxicity will be considered dose limiting. Toxicity requiring a dose reduction or a delay in treatment for >7 days will be considered dose limiting. Other Grade 3 or higher toxicity related to TRC105 will be considered dose limiting.|First 28 days of treatment (cycle 1)||||Participants|||Count of Participants
1395479|NCT01306058|Secondary|Number of Participants With Serious and Non-serious Adverse Events by Common Terminology Criteria in Adverse Events (CTCAE)v4.0|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 years and 10.5 months||||Participants|||Count of Participants
1395480|NCT01306058|Secondary|Immunogenicity of TRC105 as Measured by Human Anti-mouse Antibody (HAMA) Formation|A 5mL blood sample will be collected to assess immunogenicity. Immunogenicity will be measured by the enzyme-linked immunosorbent assay (ELISA).|Baseline and then 28 days following the end of the study treatment||2018-11-30|11/2018||||
1395481|NCT01306058|Secondary|Patients Who Developed Antidrug Antibodies|Patients who develop antidrug antibodies is measured by human anti-chimeric antibody (HACA) formation (e.g. immunogenicity of TRC105).|Cycle 1 Day 1, 28 days post end of study (up to 2 years)|11/27 were analyzed because only 11 patients were evaluable at the highest dose level given to patients.|||Participants|||Count of Participants
1395482|NCT01306058|Secondary|Overall Response Rate (ORR) as Determined by the European Association for the Study of the Liver (EASL)-Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall response (Complete Response (CR) + Partial Response (PR) was assessed by the European Association for the Study of the Liver (EASL)-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for target lesions and assessed by magnetic resonance imaging (MRI). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter of target lesions.|2 years|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
1395483|NCT01306058|Secondary|Overall Response Rate (ORR) as Determined by the Standard Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall response (Complete Response (CR) + Partial Response (PR) was assessed by the Standard Response Evaluation Criteria in Solid Tumors (RECIST) criteria for target lesions and assessed by magnetic resonance imaging (MRI). CR is disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter of target lesions.|2 years|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||percentage of participants||95% Confidence Interval|Number
1395484|NCT01306058|Primary|Phase II: Time to Progression (TTP) for the Combination of TR105 With Sorafenib in Hepatocellular Cancer (HCC)|TTP is the time between the first day of treatment to the day of disease progression. Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|2 years|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||Months||95% Confidence Interval|Median
1395485|NCT01306058|Primary|Phase I: Maximum Tolerated Dose (MTD) of TRC105 When Given With Standard-dose Sorafenib for Hepatocellular Cancer (HCC)|MTD is the highest dose studied for which the incidence of DLT was less than 33%. DLT criteria included treatment-related grade 3 non-hematological toxicities or grade 4 hematological toxicities occurring within the first 28 days of treatment. Grade 3 electrolyte toxicities to be corrected to Grade 1 or less within 24 hours will be considered dose limiting (proteinuria >3.5g/24 hour will be defined as a DLT). Drug-related Grade 4 hematological toxicity will be considered dose limiting. Toxicity requiring a dose reduction or a delay in treatment for >7 days will be considered dose limiting. Other Grade 3 or higher toxicity related to TRC105 will be considered dose limiting.|Completed in the first 28 days of treatment (cycle 1)|24/27 analyzed. One patient signed consent but developed rapid disease progression and did not receive any treatment. One patient developed a fatal myocardial infarction and one patient developed a grade 3 cerebral tumor hemorrhage.|||mg/kg|||Number
1395486|NCT01306032|Secondary|Number of Participants With Deleterious Mutations in DNA Repair Genes|Gene expression profiling was performed in archival tumor tissue for a panel of 211 genes using deoxyribonucleic acid (DNA) array to determine deleterious mutations (i.e. nonsynonymous mutations at coding regions) of genes. Sequences were mapped to human genome reference hg19. Variants were identified with VarScan, annotated with AVIA, and masked to the exonic or exonic:splicing regions of the 211 interrogated DNA repair genes, with nonsynonymous/frameshift/stop-gain/stop-loss variants that have a population frequency of 1% or less in either 1000G (2014_04) or the ExomeSequencingProject (ESP6500si_all) with a minimum variant frequency of 10% and at least 20 reads. Lastly, variants were manually inspected for known platform and mapping errors.|Optional tumor biopsies were performed prior to start of treatment (baseline) and 6 months|Patients with sufficient tumor content in archival tissue (defined as ≥70% tumor after macrodissection) were analyzed for genetic alterations in DNA repair genes by whole-exome sequencing.|||Participants|||Count of Participants
1399056|NCT01271803|Primary|Tmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.|||hours||Full Range|Median
1395488|NCT01306032|Secondary|Change in Poly-ADP Ribose (PAR) Concentration Levels From Baseline|PAR levels (in pg/μg protein) were assessed in peripheral blood mononuclear cells (PBMCs) by immunoassay to assess poly (ADP-ribose) polymerase (PARP) activity. Significant inhibition of PARP activity is associated with 50% or greater reduction in PAR levels.|At baseline (t=0h) and 4h post drug administration (t=4h)|Patients with PBMCs data pre- and post-drug administration, and with PAR levels above the lower limit of quantitation (LLOQ) of 23 pg/μg protein were analyzed.|||pg/μg protein||Full Range|Mean
1395489|NCT01306032|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|up to 30 days following the last dose of study drug.||||Participants|||Count of Participants
1395490|NCT01306032|Primary|Progression Free Survival|Time to progression for each participant for the initial intervention.|Ovarian cancer patients stayed on study for an average of 126 days and triple-negative breast cancer patients for an average of 71 days.|Participants evaluable for response.|||Cycles of therapy||Full Range|Median
1395491|NCT01306032|Primary|Percentage of Participants With an Overall Response Rate|Complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. CR + PR was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|an average of 126 days for ovarian; 71 days for TNBC; for crossover intervention, pts stayed on study for an avg of 134 days for ovarian; 50 days for TNBC.|Participants evaluable for response.|||percentage of participants|||Number
1395492|NCT01305941|Secondary|Functional Assessment Cancer Therapy- Breast (FACT-B) From Baseline to 9 Weeks of Treatment to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life|The FACT-B is a 10-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with breast cancer. Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-B subscale range from 0 to 40 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.|9 weeks|Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint|||units on a scale||Inter-Quartile Range|Median
1395493|NCT01305941|Secondary|Functional Assessment of Cancer Therapy- Brain (FACT-Br) Change From Baseline to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life|The FACT-Br is a 23-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with brain tumors . Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-Br subscale range from 0 to 92 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.|9 weeks|Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint|||units on a scale||Inter-Quartile Range|Median
1395494|NCT01305941|Secondary|Overall Survival|Overall survival (OS) after administration of everolimus in combination with trastuzumab and vinorelbine|3 years||||years||95% Confidence Interval|Median
1395495|NCT01305941|Secondary|Extracranial Time to Progression|"To evaluate the extracranial time to progression as determined by RECIST 1.1 criteria after administration of everolimus in combination with trastuzumab and vinorelbine.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Seven subjects were not evaluable for extra-cranial response due to no follow-up disease assessments due to poor clinical status; 12 subjects were excluded since they did not have extra-cranial disease at baseline; 1 subject was non compliant for follow-up scans; and 1 subject was excluded due to intracranial progression prior to extracranial.|||months||Full Range|Median
1395496|NCT01305941|Secondary|Extracranial Response|"Extracranial response was measured using RECIST 1.1 criteria and defined as the number of subjects achieving CR or PR.~Complete Response (CR) - Disappearance of all target and nontarget lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.~Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Seven subjects were not evaluable for extra-cranial response because there was no follow-up disease assessment done due to poor clinical status of subjects. An additional 12 subjects were excluded since they did not have extra-cranial disease at baseline and one additional subject was non compliant for follow-up scans.|||Participants|||Count of Participants
1395523|NCT01305564|Secondary|Filter Migration|Rate of filter indwell complications of: migration >2cm.|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of migration.|||percentage of participants||95% Confidence Interval|Number
1395497|NCT01305941|Secondary|Time to Intracranial Progression.|"Time to intracranial progression after administration of everolimus in combination with trastuzumab and vinorelbine as defined via modified RECIST criteria.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years||||months||95% Confidence Interval|Median
1395498|NCT01305941|Secondary|Toxicity|"Grade 3 or higher toxicities of interest are reported. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.~The NCI CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|24 weeks||||Participants|||Count of Participants
1395499|NCT01305941|Secondary|Intracranial Response Rate- MacDonald Criteria|"Intracranial tumor lesions were evaluated via gadolinium-enhanced brain MRI using the MacDonald criteria. Measurable disease is defined as at least 1 measurable brain lesion accurately measured in at least 2 dimensions (longest diameter) as ≥5.0 mm. Tumor size is the product of the 2 longest bi-dimensional lines.~Complete Response (CR)- Disappearance of all tumor on consecutive CT or MRI scans at least 1 month apart, off steroids for treatment of neurological symptoms, and neurologically stable or improved.~Partial Response (PR)- ≥50% reduction in size of tumor on consecutive CT or MRI scans at least 1 month part, steroids stable or reduced, and neurologically stable or improved.~Progressive Disease (PD)- ≥25% increase in size of tumor or any new tumor on CT or MRI scans, or neurologically worse, and steroids stable or increased due to neurologic symptoms.~Stable Disease (SD)- all other situations Overall Response Rate (ORR) is the sum of partial responses (PRs) and CRs."|3 years|Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects|||Participants|||Count of Participants
1395500|NCT01305941|Primary|Intracranial Objective Response Rate- Modified RECIST Criteria|"response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria.~Complete Response (CR) - Disappearance of all target and nontarget lesions~Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.~Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.~Progressive Disease (PD) – at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size."|3 years|Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects|||Participants|||Count of Participants
1395501|NCT01305811|Other Pre-specified|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|2 months||||units on a scale||Standard Deviation|Mean
1395502|NCT01305811|Primary|SF-36P|Ten items addressing physical functioning which are part of a short-form health survey with 36 questions. Scores range between 0 and 100 with higher scores indicating better function.|6 months||||units on a scale||95% Confidence Interval|Mean
1395503|NCT01305772|Secondary|Nine (9) Month Overall Survival (OS)|Overall survival (OS) was defined as from the time of enrollment to the date of death resulting from any cause. Time as censored at the date of the last follow-up visit for subjects who were still alive. The 9-month OS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are alive.|9 months||||percentage of treated patients surviving||95% Confidence Interval|Number
1395504|NCT01305772|Secondary|Nine (9) Month Progression Free Survival (PFS)|"Nine month progression-free survival (PFS) was defined from the time from enrollment to the first date of disease progression or death as a result of any cause. Progression was defined in the same manner as in RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5mm (the appearance of one or more new lesions is also considered progression).~Time was censored at the date of the last follow-up visit for subjects who were still alive and have not progressed. The 9 month PFS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are disease free or alive."|9 months||||percentage of treated patients||95% Confidence Interval|Number
1395505|NCT01305772|Primary|Change in Tumor (Primary Tumor and Lymph Node) Response and Progression Between Pre- and Post- Panitumumab Therapy|"The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined in the same manner as in RECIST 1.1.~No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants."|Baseline to 2 years|No results will be reported for the primary outcome measure as only 2 of the 6 subjects had tissue collected after the first dose of panitumumab due to safety risk to the subject.||||||
1395506|NCT01305655|Secondary|Evaluate Time at Hospital and Health Costs||6 years 6 months|||||||
1395524|NCT01305564|Secondary|Filter Fracture|Rate of filter fracture|6 months|The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of fracture.|||percentage of participants||95% Confidence Interval|Number
1395507|NCT01305655|Primary|Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage.|"Glucarpidase was used in case of predefined toxic MTX values at defined time points and/or in combination with decreased renal function.~A total of 47 patients of the 1286 ALL-patients included in the protocol (3.7 %) were treated with Glucarpidase."|6 years 6 months||||participants|||Number
1395508|NCT01305577|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
1395509|NCT01305577|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
1395510|NCT01305577|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:~How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are?” Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
1395511|NCT01305577|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
1395512|NCT01305577|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||percentage of participants|||Number
1395513|NCT01305577|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||mm||Standard Deviation|Mean
1395514|NCT01305577|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
1395515|NCT01305577|Secondary|Change From Baseline in CR-SMFRS Scores|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
1395516|NCT01305577|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.~The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
1395517|NCT01305577|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
1395518|NCT01305577|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population, which consisted of all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants|||Number
1395519|NCT01305564|Secondary|Filter Penetration >3mm at Retrieval||Pre-retrieval|The denominator of 124 is equal to the number of subjects undergoing a retrieval procedure with imaging to confirm penetration.|||percentage of participants||95% Confidence Interval|Number
1395520|NCT01305564|Secondary|Filter Penetration >3mm at Placement||Post-placement|Penetration at Placement was measured immediately post-placement but prior to retrieval.|||percentage of participants||95% Confidence Interval|Number
1395521|NCT01305564|Secondary|Filter Tilt at Retrieval|Rate of filter indwell complications of: tilt >15°|Pre-retrieval imaging|All patients undergoing a retrieval procedure.|||percentage of participants||95% Confidence Interval|Number
1395522|NCT01305564|Secondary|Filter Tilt at Placement|Rate of filter indwell complications of: tilt >15°|Post-placement imaging|Tilt was measured post-placement with vena cavagram.|||percentage of participants||95% Confidence Interval|Number
1395525|NCT01305564|Secondary|Rate of New or Worsening Deep Vein Thrombosis|Rate of new or worsening Deep Vein Thrombosis (DVT) from placement to the six month follow-up. Worsening DVT is defined as an extension of existing DVT to a new venous segment on ultrasound in patients that had DVT at the baseline visit.|6 months|The denominator of 188 is equal to the number of subjects completing the 6 month visit or with a filter retrieval procedure.|||percentage of participants||95% Confidence Interval|Number
1395526|NCT01305564|Secondary|Rate of Recurring Pulmonary Embolism|Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.|24 months||||percentage of participants||95% Confidence Interval|Number
1395527|NCT01305564|Primary|Clinical Success of Retrieval|Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here.|24 months||||percentage of participants||95% Confidence Interval|Number
1395528|NCT01305564|Primary|Technical Success of Retrieval|Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.|24 months|The denominator of 124 is equal to the number of subjects that had a filter retrieval procedure (successful and unsuccessful retrievals). Subjects were not required to have a retrieval procedure.|||percentage of participants||95% Confidence Interval|Number
1395529|NCT01305564|Primary|Clinical Success of Placement|Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.|6 months|The denominator of 189 is equal to all of the subjects that completed the 6 month visit, had their filter retrieved, or experienced a component of the clinical success of placement endpoint regardless of follow-up duration.|||percentage of participants||95% Confidence Interval|Number
1395530|NCT01305564|Primary|Technical Success of Placement|Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism.|6 months||||percentage of participants||95% Confidence Interval|Number
1395531|NCT01305473|Post-Hoc|Hernia Recurrence Rate Post Repair With Sepramesh in Subjects With Both Incisional and Umbilical Hernias|A recurrent hernia is a hernia (either umbilical or incisional), confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater|This analysis included the 5 subjects who underwent surgery to repair both incisional and umbilical hernias in the index procedure.|||participants|||Number
1395532|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Umbilical Hernias Post Repair With Sepramesh.|A recurrent umbilical hernia is an umbilical hernia, confirmed by the Investigator at any point after the surgery, in the same location as the umbilical hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 43 subjects who underwent surgery to repair umbilical hernias in the index procedure.|||participants|||Number
1395533|NCT01305473|Post-Hoc|Hernia Recurrence Rate of Incisional Hernias Post Repair With Sepramesh.|A recurrent incisional hernia is an incisional hernia, confirmed by the Investigator at any point after the surgery, in the same location as the incisional hernia that was repaired in the index procedure.|12 months or greater|The analysis population included the 42 subjects who underwent surgery to repair incisional hernias in the index procedure.|||participants|||Number
1395534|NCT01305473|Secondary|Recovery Time Associated With Hernias Repaired With Sepramesh.|Recovery time will be defined as the time it took for the subject to return to work.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|Data not available: none of the subject medical records reported return to work data. Secondary endpoint analysis could not be performed.||||||
1395535|NCT01305473|Secondary|Procedural Time for Sepramesh Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|Day 0|All enrolled subjects were included in the analysis.|||minutes||Standard Deviation|Mean
1395536|NCT01305473|Secondary|Complications in Subjects With Hernias Repaired With Sepramesh.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject’s medical files from the time surgery was initiated until the day the subject had a postoperative visit (that is, the protocol specified postoperative visit for conducting a physical examination).|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.|||participants|||Number
1395537|NCT01305473|Primary|Hernia Recurrence Rate of Hernias Post Repair With Sepramesh.|A recurrent hernia is a hernia, confirmed by the Investigator at any point after the surgery, in the same location as the hernia repaired in the index procedure.|12 months or greater (average follow-up time of 3 years; range 13-65 months)|All enrolled subjects were included in the analysis.|||participants|||Number
1395538|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395577|NCT01305213|Primary|Progression-free Survival (PFS)|The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years|All intent to treat patients|||months||95% Confidence Interval|Median
1395539|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395540|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395541|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395542|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395543|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395544|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395545|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395546|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395547|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395548|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395549|NCT01305408|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1395550|NCT01305408|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1395551|NCT01305408|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1395552|NCT01305408|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1395578|NCT01305200|Other Pre-specified|Ancillary Validation Study of ChIMES||Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Analysis is not performed at this time due to no available funding and no human resource allocated to this study.||||||
1395553|NCT01305408|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.|||participants|||Number
1395554|NCT01305408|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1395555|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1395556|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1395557|NCT01305408|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1395558|NCT01305408|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
1395559|NCT01305408|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
1395579|NCT01305200|Secondary|Severity of Mucositis|Area Under the Curve of Severity of Mucositis. According to mouth pain categorical rating scale ranges 0-10 with higher scores reflecting more severe pain.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation|Evaluable patients defined as patients with ≥11 daily WHO assessments.|||units on a scale * day||Standard Deviation|Mean
1395560|NCT01305408|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1395561|NCT01305265|Primary|Incidence of Tracheopharyngeal Symptoms||within 2 hours after extubation||||participants|||Number
1395562|NCT01305252|Secondary|B-type Natriuretic Peptide (BNP)|B-type Natriuretic peptide measures the percent change from baseline.|Baseline and 24 weeks||||percent change||Standard Deviation|Mean
1395563|NCT01305252|Secondary|Change in NYHA/WHO Class|"At 48 week,WHO/NYHA functional class was assessed for change in WHO/NYHA functional class.Change NYHA is measured as decrease or increase in NYHA class in the subjects compared with baseline.~NYHA /WHO functional class is described below:~NYHA functional class I:no symptoms and no limitation in ordinary physical activity NYHA functional class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA functional class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity NYHA functional class IV:Severe limitations. Experiences symptoms even while at rest A higher functional class represent worse symptoms."|Baseline and 48 week||||participants|||Number
1395564|NCT01305252|Secondary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|Change from baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|Baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
1395565|NCT01305252|Secondary|6 Minute Walk Distance|Change in 6MWD during 24 week period compared between Tada and Tada+iTre.|Baseline and 24 weeks||||meters||Inter-Quartile Range|Mean
1395566|NCT01305252|Primary|Change in Right Ventricular Ejection Fraction|Effect of dual-upfront therapies versus mono-therapy on percent change of right ventricular function assesed by cardiac MRI (cMRI) at 24 weeks compared with the baseline.|Basline and 24 weeks||||percent change||Inter-Quartile Range|Mean
1395567|NCT01305239|Secondary|Event-free Survival|Event-free survival: time between first intake of exemestane and date of last follow-up or date of death for deceased participants (date of relapse or death or last follow-up minus first intake date) + 1 / 365.25 * 12.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|ITT population = all participants who received at least 1 dose of study drug and had at least 1 follow-up questionnaire completed. N = number of participants with analyzable (non-missing) data.|||months||95% Confidence Interval|Mean
1395568|NCT01305239|Secondary|Duration of Treatment|Total duration of adjuvant hormonal therapy with exemestane.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set; N = number of participants with analyzable (non-missing) data. For 2 participants lost to follow-up, the duration of exemestane was calculated until the date of lost to follow-up.|||months||Standard Deviation|Mean
1395569|NCT01305239|Secondary|Percentage of Participants Who Were Compliant With Treatment|Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. Information on compliance was not available for subjects who did not have a follow-up visit. N = number of participants with analyzable data.|||percentage of participants||95% Confidence Interval|Number
1395570|NCT01305239|Secondary|Reasons for Discontinuation of Aromasin Therapy||Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set. N = number of participants with follow-up visit(s) who discontinued treatment with exemestane.|||participants|||Number
1395571|NCT01305239|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed|Safety set: all participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1395572|NCT01305213|Secondary|Response by CA-125|The effects of treatment on the proportion responding by CA125 will be examined.|Up to 5 years||||Percentage of Participants||95% Confidence Interval|Number
1395573|NCT01305213|Secondary|Overall Survival (OS)|Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.|Up to 5 years||||months||90% Confidence Interval|Median
1395574|NCT01305213|Secondary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.0|for those patients whose disease can be evaluated by physical examination, response wa assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years|Patients with measurable disease|||percentage of participants||90% Confidence Interval|Number
1395575|NCT01305213|Secondary|Measurable Disease by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria and Progression Free Survival (PFS)|Differences between measurable versus non-measurable disease status on PFS and OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.|Up to 5 years||||months||95% Confidence Interval|Median
1395576|NCT01305213|Secondary|Incidence of Adverse Events (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 4.0|Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.|Up to 5 years|All eligible and treated patients|||Participants|||Count of Participants
1395580|NCT01305200|Secondary|Incidence of Invasive Bacterial Infections|Invasive Bacterial Infection = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||percentage of participants|||Number
1395584|NCT01305200|Secondary|Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).|Morphine equivalent dose in mg/kg/day|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||mg/kg/day of opioid analgesics||Full Range|Median
1395585|NCT01305200|Secondary|Duration of Parenteral Opioid Analgesic Use (Morphine Equivalents).|Mean days of parenteral opioid analgesic use.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II).|||Days||Standard Deviation|Mean
1395586|NCT01305200|Secondary|Incidence of Parenteral Opioid Analgesic Use (Morphine Equivalents).|Opioid Administration = yes|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Total of 210 patients evaluable for this assessment (106 Arm I & 104 Arm II)|||percentage of participants|||Number
1395587|NCT01305200|Secondary|Oral Mucositis Daily Questionnaire (OMDQ)|Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation|Evaluable patients defined as patients with ≥11 daily WHO assessments.|||units on a scale * day||Standard Deviation|Mean
1395588|NCT01305200|Secondary|Incidence of Severe Oral Mucositis|Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Evaluable patients defined as patients with >= 11 daily WHO assessments.|||percent of patients|||Number
1395589|NCT01305200|Primary|Duration of Severe Oral Mucositis (WHO Grade 3 or 4)|Mean days of severe (WHO Grade 3 or 4) Mucositis.|Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.|Evaluable patients defined as patients with >= 11 daily WHO assessments.|||Number of days||Standard Deviation|Mean
1395590|NCT01305044|Primary|Satisfaction With the Randomized Controlled Trial|The 12-week intervention assessed satisfaction with intervention(0=strongly agree to 4=strongly disagree).|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.|||units on a scale||Inter-Quartile Range|Median
1395591|NCT01305044|Secondary|Inflammatory Cytokines|Fasting blood samples were collected in the morning for inflammatory cytokines. Prior to blood draws, we ensured that participants did not experience illness or fever at the time of the blood draw. The assayed cytokines included pro-inflammatory cytokines interleukin(IL)-12, IL-6, tumor necrosis factor (TNF)-α, and anti-inflammatory cytokines IL-10 and IL-4.|13-weeks||||pg/ml||Inter-Quartile Range|Median
1395592|NCT01305044|Secondary|Cortisol Area-Under-Curve (AUC)|Five saliva samples (awakening, 30 minutes after awakening, noon, 5pm, & 10pm) were collected on a weekend day at one week after class completion. Cortisol was measured in nmol/L. Cortisol AUC was calculated using the five timepoints with the trapezoid rule. The groups were compared at post-intervention on their log transformed cortisol AUC controlling for baseline cortisol and reported as adjusted means. Four participants with high cortisol profiles across the five collection times (with suspected contamination from gum bleeding) and participants whose collection time was beyond a one hour window were excluded.|13-weeks||||nmol*hr/L||Standard Error|Mean
1395593|NCT01305044|Secondary|Blood Pressure|Systolic and Diastolic blood pressure were assessed at the study's physical assessment sessions.|13-weeks|Please refer to power calculation detailed in Primary Outcome Measure.|||mm Hg||Standard Error|Mean
1395594|NCT01305044|Secondary|Five-Facet Mindfulness Questionnaire|The Five-Facet Mindfulness questionnaire produces a total score and five facet subscales (observing, describing, acting with awareness, nonjudging, & nonreactivity). These are summation scores, and the scores range from 8 to 40 (except for the nonreactivity facet which ranges from 7 to 35). Higher scores indicate more mindfulness. The Total Score ranges from 39-195, with higher scores indicating more mindfulness.|13-weeks||||units on a scale||Inter-Quartile Range|Median
1395595|NCT01305044|Secondary|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality produces a global score. The range is 0 to 21, higher scores indicate worse sleep quality.|13-weeks||||units on a scale||Inter-Quartile Range|Median
1395596|NCT01305044|Secondary|Impact of Events Scale|The Impact of Event Scale assesses cancer-specific distress. Each item is scored 0 (not at all), 1 (rarely), 3 (sometimes)or 5 (often), with the higher scores reflecting more stressful impact. It has a total score and two subscales (avoidance & intrusion). The two subscales are scored by summing their corresponding items and the total score is the sum of two subscales. The scores for the intrusive subscale range from 0 to 35, and scores for the avoidance subscale range from 0 to 40. The Total Score ranges from 0-75, with higher scores reflecting more stressful impact.|13-weeks||||units on a scale||Inter-Quartile Range|Median
1395597|NCT01305044|Secondary|Perceived Stress Scale|The 10-item perceived stress scale produces a summation score. Scores can range from 0 to 40, with higher scores indicating more stress.|13 weeks||||units on a scale||Inter-Quartile Range|Median
1395598|NCT01305044|Secondary|Health-Related Quality of Life (Short Form (SF)-36v1)|SF-36v1 Health Survey assesses quality of life and produces mental and physical component summary scores, with a score range of 0 to 100. Higher scores indicate better quality of life.|13 weeks|Please refer to power calculation detailed in Primary Outcome Measure.|||units on a scale||Standard Error|Mean
1395599|NCT01305044|Primary|Retention Rates and Class Attendance|The 12-week intervention assessed retention in the study (percentage of how many participants remained enrolled the entire intervention), class attendance (percentage out of possible classes)|13 weeks|Power calculations indicated that a sample size of 42 would be sufficient to detect 15 point change in SF-36, with 88% power at 5% significance level. Analysis were per protocol because the sample size was too small for imputation techniques and there was no follow-up data on withdrawn participants for intent-to-treat analysis.|||percentage of participants|||Number
1395600|NCT01304966|Secondary|Cotreta-Derkay Score|"We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes~Coltera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.~Coltera-Derkay method of staging :~Clinical score:~Voice: Normal - 0, Abnormal - 1, Aphonia - 2~Stridor: Absent - 0, Present on activity - 1, Present at rest - 2~Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.~Anatomical score:~For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.~Total score = Anatomical score + Total clinical score"|12 months||||score||Standard Deviation|Mean
1395601|NCT01304966|Primary|Human Papillomavirus Genotypes|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy|12 months|We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively.|||participants|||Number
1395602|NCT01304706|Primary|Number of Participants With Adverse Events|This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.|12 months||||participants|||Number
1395603|NCT01304693|Secondary|Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria|Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.|Time to event, up to Month 6|ITT: All patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit.|||Days||Inter-Quartile Range|Median
1395604|NCT01304693|Primary|Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)|CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.|Baseline, Month 1|This analysis population includes all patients who were randomized, received study drug, and completed at least 1 scheduled on-therapy study visit (ITT). Efficacy data from visits occurring after standard of care (SoC) were censored and replaced based on LOCF,i.e. by the data observed at the time of the SoC decision.|||microns||Standard Deviation|Mean
1395605|NCT01304641|Secondary|Percentage of Participants Who Adhered to Index Therapy|Percentage of participants who adhered to index therapy was evaluated. Treatment adherence was defined as the number of days covered by index medication divided by the number of days in the post-index period, expressed as a percentage.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Percentage of participants|||Number
1395606|NCT01304641|Secondary|Length of Post-index Period|Post-index period included time during which participants were observed for a minimum of 3 months following index date (fill date on which first observed atorvastatin or simvastatin was filled during the participant identification period) until disenrollment or end of study treatment (28 February 2009).|Index date (baseline) up to end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Days||Standard Deviation|Mean
1395607|NCT01304641|Secondary|Number of Participants Per Dose|Index dose was categorized as low dose (atorvastatin 10 mg, simvastatin up to 20 mg), medium dose (atorvastatin 20 mg, simvastatin 40 mg), and high dose (atorvastatin 40 or 80 mg, simvastatin 80 mg).|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Participants|||Number
1395608|NCT01304641|Secondary|Mean Dose|The first observed study medication fill during the participation identification period was defined as the index drug. The initial dose of the index drug was determined based on the pharmacy claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||mg||Standard Deviation|Mean
1395609|NCT01304641|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)||At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1395610|NCT01304641|Primary|Hazard Ratio for First Cardiovascular (CV) Event|Hazard ratio of atorvastatin versus simvastatin for first CV event. Hazard ratio of atorvastatin versus simvastatin was obtained from a Cox proportional hazards model.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Participants|||Number
1395611|NCT01304641|Primary|Number of Participants With Post-index Cardiovascular (CV) Events|CV events were defined as an inpatient or emergency department admission for heart failure (HF), myocardial infarction (MI), ischemic heart disease (IHD), cerebrovascular disease, peripheral vascular disease (PVD), aortic aneurysm, and/or revascularization. CV events were identified using medical claims.|At least 3 months from the post-index date (baseline) or end of study (28 February 2009)|Evaluable analysis population included all participants who met inclusion criteria.|||Participants|||Number
1395612|NCT01304589|Secondary|24-hour Vulvar Pain|"0 equals no vulvar pain within the last 24 hours to 10 equals worse imaginable vulvar pain within the last 24 hours. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were randomized to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes all 18 eligible subjects who completed all of the study visits.|||units on a scale||Standard Deviation|Mean
1395613|NCT01304589|Secondary|Coital Pain|"0 equals no pain with intercourse to 10 equals worse imaginable pain with intercourse. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were assigned to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes the 18 eligible subjects who completed all of the study visits.|||units on a scale||Standard Deviation|Mean
1395614|NCT01304589|Secondary|Tampon Pain|"0 equals no pain with tampon insertion to 10 equals worse pain imaginable with tampon insertion. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were eligible and received study medication. Analysis population includes all 22 eligible subjects.|||units on a scale||Standard Deviation|Mean
1395615|NCT01304589|Primary|Pain Rating Index|"The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. 0 equals no pain to 45 equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment."|18 weeks|22 subjects were eligible and received study medication. Analysis population included all 22 eligible subjects.|||units on a scale||Standard Deviation|Mean
1395616|NCT01304498|Secondary|Percentage of Participants With One or More Serious Adverse Events|A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed.|Up to Month 7|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
1395617|NCT01304498|Secondary|Percentage of Participants With Maximum Oral Temperature ≥37.8°C|The percentage of participants with maximum oral temperature ≥37.8°C was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
1395618|NCT01304498|Secondary|Percentage of Participants With One or More Systemic Adverse Events|The percentage of participants with one or more systemic adverse events was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
1395619|NCT01304498|Secondary|Percentage of Participants With One or More Injection-site Adverse Reactions|The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.|Up to 5 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
1395620|NCT01304498|Secondary|Percentage of Participants With One or More Adverse Events|An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. The percentage of participants with one or more adverse events was assessed.|Up to Month 7|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
1395621|NCT01304498|Secondary|Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||Percentage of participants||95% Confidence Interval|Number
1395622|NCT01304498|Secondary|GMTs to HPV Types 6 and 11|Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
1395623|NCT01304498|Primary|Geometric Mean Titers (GMTs) to HPV Types 16 and 18|Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.|4 weeks postdose 3 (Month 7)|All randomized participants. The n values are participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology to the HPV type within acceptable day ranges, were seronegative to the HPV type at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
1395624|NCT01304329|Secondary|Simvastatin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1395625|NCT01304329|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1395626|NCT01304329|Primary|Simvastatin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1395627|NCT01304329|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~The geometric mean and geometric coefficient of variation (gCV) are adjusted values"|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1395628|NCT01304329|Primary|Simvastatin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. Simvastatin acid is an active metabolite of simvastatin.~The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1395629|NCT01304329|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~The geometric mean (gMean) and geometric coefficient of variation (gCV) are adjusted values."|0 hours (h), 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: PK set included all evaluable subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1395630|NCT01304316|Secondary|Pulse Rate Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||bpm||Standard Deviation|Mean
1395631|NCT01304316|Secondary|Systolic BP Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||mmHg||Standard Deviation|Mean
1395632|NCT01304316|Secondary|Diastolic BP Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||mmHg||Standard Deviation|Mean
1395633|NCT01304316|Secondary|Pulse Oximetry Maximum Change From Baseline||Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||% oxygen||Standard Deviation|Mean
1395634|NCT01304316|Primary|Half Life of PBBA|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 8 subjects in the standard dose group and 11 subjects in the high dose group had sufficient concentration levels to calculate Cmax.|||h||Standard Deviation|Mean
1395635|NCT01304316|Primary|Half Life of Tetracaine|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|An insufficient number of tetracaine plasma concentrations existed in each subject to determine a half life for tetracaine||||||
1395636|NCT01304316|Primary|Half Life of Oxymetazoline|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 7 subjects in the 0.3 mg dose group and 0.6 mg dose group had sufficient concentration levels to calculate the half life.|||h||Standard Deviation|Mean
1395637|NCT01304316|Primary|Cmax of PBBA|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes||||ng/mL||Standard Deviation|Mean
1395638|NCT01304316|Primary|Cmax of Tetracaine|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 4 subjects in the 18 mg dose group and 7 subjects in the 36 mg dose group had sufficient concentration levels to calculate Cmax.|||ng/mL||Standard Deviation|Mean
1395639|NCT01304316|Primary|Cmax of Oxymetazoline|Extra-vascular, non-compartmental analysis is used to derive pharmacokinetic parameters; estimated from observed plasma concentration values, the dose administered, the AUCs, and the terminal elimination phase rate constant for each dose group|Baseline, 5, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes|Only 11 subjects in the 0.3 mg dose group had sufficient concentration levels to calculate Cmax.|||ng/mL||Standard Deviation|Mean
1395640|NCT01304277|Secondary|Overall Summary of TEAEs by Treatment (Replagal RB and Replagal AF)|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status, concomitant medication, vital signs and ECG.|Week 2 to EOS||||participants|||Number
1395641|NCT01304277|Secondary|To Assess Safety and Tolerability by Anti-agalsidase Alfa Antibody Status (in Serum) at End of Study||EOS||||participants|||Number
1395642|NCT01304277|Secondary|Dose-normalized Maximum Serum Concentration (Cmax/Dose)||Week 0 to Week 14||||Ratio||90% Confidence Interval|Geometric Mean
1395643|NCT01304277|Secondary|Dose-normalized AUC Extrapolated to Infinity (AUC∞/Dose)||Week 0 to Week 14||||Ratio||90% Confidence Interval|Geometric Mean
1395644|NCT01304277|Secondary|Dose-normalized Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast/Dose)||Week 0 to Week 14||||Ratio||90% Confidence Interval|Geometric Mean
1395645|NCT01304277|Secondary|Change From Baseline to Week 16 (EOS) in Plasma Gb3 Levels||Baseline to EOS||||(nmol/mL)||Standard Deviation|Mean
1395646|NCT01304277|Primary|Change From Baseline to Week 16 (EOS) in Urine Gb3 Levels||Baseline to EOS||||(nmol/g creatinine)||Standard Deviation|Mean
1395647|NCT01304238|Secondary|Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
1395648|NCT01304238|Secondary|Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
1395649|NCT01304238|Secondary|Number of Participants Who Underwent Amputation After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
1395650|NCT01304238|Secondary|Number of Participants With Fatal Complications After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
1395651|NCT01304238|Secondary|Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II|Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files.|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
1395652|NCT01304238|Primary|Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II|Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants’ medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs).|19 January 2005 to 25 October 2009|All documented participants diagnosed with suspected acute HIT II and a 4T Score of ≥4 who had received at least one dose of argatroban, lepirudin, danaparoid, or fondaparinux. The 4T score (range: 0-8) was developed to predict the probability of HIT.|||participants|||Number
1395653|NCT01304147|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.|2 weeks|Number of events, more detailed in adverse event section|||events|||Number
1395654|NCT01304147|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"Number of patients meeting response criteria of >=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration~10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points."|24 hours|20 patients randomized and 18 completed both treatment periods|||participants|||Number
1395655|NCT01304082|Secondary|Rank-transformed Pain Score Upon Needle Stick.|"Pain score upon needle stick:~The pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable)."|1 minute after each injection||||rank||95% Confidence Interval|Least Squares Mean
1395656|NCT01304082|Secondary|Rank-transformed Time (Seconds) Until Anesthesia|Rank-transformed time (seconds) until anesthesia will be assessed using a repeated sensory stimulus.|0-180 seconds after each injection||||rank||95% Confidence Interval|Least Squares Mean
1395657|NCT01304082|Secondary|Rank-transformed Time (Seconds) Until Hypoesthesia|Rank-transformed time (seconds) until hypoesthesia will be assessed using a sensory stimulus|0-180 seconds after each injection.||||rank||95% Confidence Interval|Least Squares Mean
1395658|NCT01304082|Primary|Rank-transformed Pain Score|"Pain score upon injection of local anesthetic:~the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable)."|immediate, upon injection of each solution||||rank||95% Confidence Interval|Least Squares Mean
1395659|NCT01303861|Secondary|Continuous Cigarette Abstinence From Quit Date|Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).|From Quit date to end of treatment (week 11)|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.|||participants||95% Confidence Interval|Number
1395660|NCT01303861|Secondary|Seven Day Point Abstinence From Cigarette Smoking|Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.|Six months post quit date|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.|||participants||95% Confidence Interval|Number
1395661|NCT01303861|Primary|Four-week Continuous Abstinence From Cigarette Smoking|The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.|Study week 8 thru week 11|1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.|||percentage of participants||95% Confidence Interval|Number
1395676|NCT01303445|Secondary|Plasma Dipyridamole Minimum Concentration (Cmin)|Minimum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1395662|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline|Patients completed neurocognitive testing at each QoL measurement assessment. Neurocognitive function was measured via a computerized neurocognitive test battery called CNS Vital Signs. The battery consists of 7 tests that assess verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention, and continuous performance. The battery provides scores over 9 domains with higher scores indicating better performance. Scores were normalized to a standard score mean of 100 and standard deviation of 15 using a normative sample. The mean difference in score in each domain between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in mean score, while a difference less than 0 indicates a decrease in mean score.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial CNS Vital Signs assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.|||Scores on a Scale||Standard Deviation|Mean
1395663|NCT01303835|Secondary|Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline|Patients completed the 6-minute walk test (6MWT) at each QoL measurement assessment. The 6 minute walk test is a measure of functional capacity in which the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes is measured. The mean difference in distance traveled (in meters) between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in distance traveled, while a difference less than 0 indicates a decrease.|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial 6MWT assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.|||Meters||Standard Deviation|Mean
1395664|NCT01303835|Primary|Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline|"The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated.~Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132)~Functional Assessment of Chronic Illness Therapy (FACIT-F) measures level of fatigue during patients’ usual daily activities (range 0-52)~Epworth Sleepiness Scale measures level of daytime sleepiness. Note that higher scores indicate a greater level of sleepiness (range 0-24)~Medical Outcomes Survey (MOS) measures QoL including physical, mental and general health via 8 domains (range 0-100 for each domain)~Zung Self-Rating Depression Scale quantifies the depressed status of a patient. Lower scores indicate more favorable outcome (range 20-80) A difference"|Baseline and 16 weeks|This analysis only includes those patients who completed both the initial QOL assessments and the 16 week QoL assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.|||Scores on a Scale||Standard Deviation|Mean
1395665|NCT01303744|Secondary|Changes in Plasma ΔTNFα Concentrations||29 days|ITT|||pg/ml||Standard Error|Mean
1395666|NCT01303744|Secondary|Measurement of Trough CHF 5074 Plasma Levels|evaluate the pharmacokinetics (PK) of CHF 5074 in patients with MCI.|Days 85||||ng/ml||Standard Deviation|Mean
1395667|NCT01303744|Primary|Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point|To assess if there were differences in ΔsCD40L levels between CHF 5074 doses and placebo|up to 12 weeks|ITT|||pg/ml||Standard Error|Mean
1395668|NCT01303627|Primary|Smooth cLMA Removal Condition (Score 1)|cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)|At the end of the surgery||||percentage of participants|||Number
1395669|NCT01303510|Secondary|Incidence of Solicited Systemic Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population|||Subjects|||Number
1395670|NCT01303510|Primary|Fold Increase in Geometric Mean Titer (GMT)|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|Day 22/Day 1|ITT/ATP|||Fold (ratio)|||Number
1395671|NCT01303510|Primary|Seroprotection|Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40|Day 22 ± 2 days|ITT/ATP|||Subjects|||Number
1395672|NCT01303510|Primary|Seroconversion|Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40|Day 22 ± 2 days|Intention-to-treat (ITT) and According-to-protocol (ATP) populations exclude one subject lost to follow up|||Subjects|||Number
1395673|NCT01303510|Secondary|Safety: Incidence of Solicited Local Adverse Events|Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination|Days 1 to 4 inclusive, and Day 22|Safety population includes all subjects who received study vaccine|||Subjects|||Number
1395674|NCT01303445|Secondary|Percentage Peak-to-trough Fluctuation (%PTF)|PTF = 100*((Cmax-Cmin)/Cavg) where Cavg=(AUC0-12)/12.|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||percent of average hourly plasma conc.||Standard Deviation|Mean
1395675|NCT01303445|Secondary|Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)|IPA12 equals the platelet aggregation measured 12 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.|||percent of baseline platelet aggregation||Standard Deviation|Mean
1395677|NCT01303445|Primary|Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)|IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no platelet inhibition was expected for this treatment.|||percent of baseline platelet aggregation||Standard Deviation|Mean
1395678|NCT01303445|Primary|Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)|Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||(nanogram/milliliter)*hours||Geometric Coefficient of Variation|Geometric Mean
1395679|NCT01303445|Primary|Plasma Dipyridamole Maximum Concentration (Cmax)|Maximum measured concentration of dipyridamole in plasma|7 days|The pharmacokinetic data set (PK set) and the pharmacodynamic data set (PD set) include all treated subjects with data that do not have a relevant protocol violation (relevant to PK or PD). No data collected for Omeprazole arm since no plasma dipyridamole was expected for this treatment.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1395680|NCT01303406|Secondary|Comparison of the Percentage of Participants Randomised to Idebenone and Placebo Who Withdrew Early Due to Recurrence or Worsening of FRDA Symptoms|There was no Withdrawal due to recurrence or worsening of FRDA symptoms|Within 2 months (i.e. Early withdrawal visit)||||percentage of patients|||Number
1395681|NCT01303406|Primary|Patient Assessment of Treatment Assignment: Comparison of the Proportions of Patients Randomised to Idebenone and Placebo Who Assessed That They Received Idebenone|The primary efficacy endpoint was the comparison of the number of patients randomized to idebenone and placebo, who assessed that they received idebenone treatment.|At 2 months after study start||||participants|||Number
1395682|NCT01303380|Secondary|Number of Participants Exhibiting Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using bridging ECLIA assay.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.|||Number of participants|||Number
1395683|NCT01303380|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of sandwich ELISA assay with limit of detection at 0.1 picogram/millilitre.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.|||picogram(s)/milliliter||Standard Deviation|Mean
1395684|NCT01303380|Secondary|Serum Concentration-time Profile of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics (PK) of the drug.|Day 1 (Pre-dose), Day 4, Day 15, Day 43, Day 85, Day 127, Day 169 (End of treatment period), Day 197, Day 225, Day 253, Day 281, Day 309, and Day 337 (End of follow-up period) (Post-dose)|The analysis was performed on the FAS population.|||microgram(s)/milliliter||Standard Deviation|Mean
1395685|NCT01303380|Secondary|Participants Who Received Rescue Treatment|Participants who experienced flares were treated with corticosteroids and NSAIDs as rescue medication.|Baseline up to Month 36 (End of study)|The analysis was performed on the FAS population.|||Percentage of participants|||Number
1395686|NCT01303380|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (Start of study treatment) up to Month 36 (End of study)|The analysis was performed on Safety Set (SAF) population defined as all participants who received at least one application of study treatment and had at least one post-baseline safety assessment.|||Number of participants|||Number
1395687|NCT01303380|Secondary|Time to Flare After the Last Dose of Canakinumab During the Follow-up Period|The median time to flare by the participants after administration of the last dose of canakinumab during the follow-up period was analysed using Kaplan-Meier method.|Last dose of canakinumab treatment in follow-up period to end of follow-up period (Day 337)|"The analysis was performed on the FAS population. Here Number of participants analysed signifies the participants assessed for time to flare after the last dose of canakinumab during follow-up period."|||days||Full Range|Median
1395688|NCT01303380|Secondary|Duration of Flares Experienced During the Study|Flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L. The change in post canakinumab treatment flare duration during the study were assessed as compared to historical period.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.|||Days||Full Range|Median
1395689|NCT01303380|Secondary|Percentage of Participants Who Received Dose Up-titration During 6-month Treatment Period|Participants who experienced a new HIDS flare between baseline and Week 4 and received an escalated dose of 450 mg of canakinumab every 6 weeks thereafter starting at Week 6 were determined.|Day 1 up to Month 6 (End of follow up)|The analysis was performed in the FAS population.|||Percentage of participants|||Number
1395764|NCT01302548|Secondary|Number of Patients Prescribed Oral Antibiotics|Number of patients prescribed oral antibiotics|48 hours||||participants|||Number
1395861|NCT01301950|Secondary|Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures|Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .|Intraoperative (Total duration of procedure)|No cost data were collected, resulting in a sample size of 0.||||||
1395690|NCT01303380|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Global Score in Children Over Time|Participants or their parents (participants aged 6 to 17 years) were assessed for HRQoL based on Childhood Health Assessment Questionnaire (CHAQ). CHAQ was an eight domain questionnaire representing functional capacity and independence, evaluated for previous week. Each domain was rated on a 4-point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do.The total score is the mean from the 8 scores, and ranges from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for CHAQ during study."|||Score on a scale||Full Range|Median
1395691|NCT01303380|Secondary|Health Assessment Questionnaire (HAQ) Global Score in Adults Over Time|Participants were assessed for health-related quality of life (HRQoL) based on Health Assessment Questionnaire (HAQ). HAQ was an eight 8 categories questionnaire representing all activities related to physical function. Each category has various sub-categories, which were rated by the participants on a 4- point difficulty scale: 0 = any difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. The total score was the mean of the 8 scores, and ranged from 0 (no disability) to 3 (completely disabled).|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|"The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively. Here Number of participants analyzed signifies the participants assessed for HAQ during study."|||Score on a scale||Full Range|Median
1395692|NCT01303380|Secondary|Change From Baseline in Inflammation Markers Over Time up to Month 24|The C-reactive Protein (CRP) and/or Serum amyloid A protein (SAA) were used as inflammatory markers. The normal range of CRP was 0-10 mg/L.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group respectively.|||milligram(s)/liter||Full Range|Median
1395693|NCT01303380|Secondary|Time to Resolution of the Initial Flare After First Canakinumab Treatment|Time to resolution of the initial flare after first dose of canakinumab was determined.|Day 1 (Baseline), Day 28|The analysis was performed in the FAS population.|||Days||Full Range|Median
1395694|NCT01303380|Secondary|Percentage of Participants Experiencing Abdominal Pain as Assessed by Physician's Global Assessment|Abdominal pain was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1395695|NCT01303380|Secondary|Percentage of Participants Experiencing Lymphadenopathy as Assessed by Physician's Global Assessment|Lymphadenopathy severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1395696|NCT01303380|Secondary|Percentage of Participants Experiencing Apthus Ulcers as Assessed by Physician's Global Assessment|Apthus ulcers were assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1395697|NCT01303380|Secondary|Percentage of Participants Experiencing Fever as Assessed by Physician's Global Assessment|Fever severity was assessed by physician after each flare using a 5-point scale: 0 =Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1395698|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Physician Assessed Symptom Control|Participants were assessed by physician for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1395699|NCT01303380|Secondary|Percentage of Participants With Defined Grades of Participants Assessed Symptom Control|Participants were assessed by participants/parent (participants aged 6-18 years) for control of signs and symptoms associated with HIDS based on 5-point scale: 0 = No control; 1 = Poor control; 2 = Somewhat control; 3 = Good control; and 4= Excellent control.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
1395700|NCT01303380|Secondary|Number of Participants With Flare Events Based on Participant Assessed HIDS Flare Severity Score|Participant's global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5-point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe. Same investigator assessed the same participant throughout the study to ensure consistency between assessments. Investigators reviewed every participant's diary at each visit after their own clinical assessment.|Baseline, Month 6 (End of treatment period), Month 12 (End of follow up period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.|||Number of participants|||Number
1395701|NCT01303380|Secondary|Number of Participants With Flare Events Based on Physician Assessed HIDS Flare Severity Score|Physician global assessment of severity of HIDS after each flare was based on HIDS flare severity score, a 5­ point scale: 0 = Absent signs/symptoms; 1 = Minimal signs/symptoms; 2 = Mild; 3= Moderate; 4 = Severe.|Any flare event [Baseline up to Month 36 (End of long term treatment period 2)]|The analysis was performed in the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Number of participants|||Number
1395702|NCT01303380|Secondary|Number of Participants Who Flared at Month 6, Month 24 and Month 36|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Baseline, Month 6 (End of treatment period), Month 24 (End of Long term treatment period 1) and Month 36 (End of Long term treatment period 2)|The analysis was performed in the FAS population.|||Number of participants|||Number
1395703|NCT01303380|Secondary|Number of Flares Per Participant at During Treatment Period and 24 Month Extension Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a CRP value > 10 mg/L.|Month 6 (End of treatment period), Month 36 (End of Long term treatment Period 2)|The analysis was performed in the FAS population.|||Number of flares||Full Range|Median
1395704|NCT01303380|Primary|Number of Flares Per Participant During Historical Period and Treatment Period|A flare was defined as Physician Global Assessment of HIDS flare severity score of ≥ 2 and a C­reactive protein (CRP) value > 10 mg/L. Flares during a historical period were defined as most recent 6-months in which the participant has not received treatment for their HIDS other than symptomatic treatment with NSAIDs and/or corticosteroids.|Historical period, Month 6 (End of treatment period)|The primary analysis was performed in the Full Analysis set (FAS) population defined as all participants who received at least one dose of study treatment and had at least one post baseline assessment.|||Number of flares||Full Range|Median
1395705|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Male ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the male population (226)|||participants|||Number
1395706|NCT01303224|Other Pre-specified|Subgroup Analysis: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort According to the 75% Rule in the Female ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat in the female population (333)|||participants|||Number
1395707|NCT01303224|Secondary|Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)|Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from “0”= worst imaginable health state to “100”=best imaginable health state.|Eight weeks|Intention-to-treat; i.e. all ITT patients who provided EQ-5D data at Visit 2 (start of treatment) and Visit 4 (end of treatment).|||units on a scale||Standard Deviation|Mean
1395708|NCT01303224|Secondary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population|"Weekly binary questions (yes/no) from IV/WRS diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule)"|Eight weeks|Intention-to-Treat (559)|||participants|||Number
1395709|NCT01303224|Primary|Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).|"Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: Did you have satisfactory relief of your overall IBS symptoms during the last week? and Did you have satisfactory relief of your abdominal pain or discomfort during the last week?~Responder: Report of satisfactory overall IBS symptom relief =Yes and of satisfactory abdominal pain/discomfort relief = Yes 6/8 weeks (75% rule)"|Eight weeks|Intention-to-Treat (559)|||participants|||Number
1395710|NCT01303159|Secondary|Number of Participants With Adverse Events|To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer|2 years|Preliminary analyses because study was terminated before follow up data could be collected.|||participants|||Number
1395711|NCT01303159|Primary|Change From Baseline in Bile Duct Stricture Diameter|To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer|2 years|Participants not analyzed has study was terminated before follow up data could be collected.||||||
1395940|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region 24 h After the Procedure|The evaluations using the soft brush were performed 2–3 cm from the incision in the periumbilical region (where the large trocar was placed) 24 h after the procedure|24 h after the procedure||||participants|||Number
1395712|NCT01302938|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria for potentially clinically significant (PCS) laboratory values: Hemoglobin, hematocrit, red blood cell less than (<) 0.8 lower limit of normal(LLN); platelet <0.5 LLN, >1.75 upper LN (ULN);white blood cell <0.6 LLN, >1.5 ULN; lymphocyte, total neutrophil(absolute[AL]),Total protein, albumin, phosphate <0.8 LLN, >1.2 ULN; basophil, eosinophil, monocyte >1.2ULN; Total bilirubin >1.5ULN; aspartate, alanine aminotransferase, alkaline phosphatase >3ULN; Blood urea nitrogen, creatinine >1.3ULN; sodium <0.95LLN, >1.05ULN; potassium, chloride, bicarbonate, calcium <0.9LLN, >1.1ULN.|Week 12|Safety set included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1395713|NCT01302938|Other Pre-specified|Number of Participants Who Discontinued the Study Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.|||participants|||Number
1395714|NCT01302938|Other Pre-specified|Number of Participants With Adverse Events (AEs) by Relatedness and Severity|AE:any untoward medical occurrence attributed to study medication in participant who received study drug. Relatedness to study medication was assessed by the investigator. Severity of AEs assessed as: mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Mild, moderate and severe are not mutually exclusive; hence same participant may be included in more than 1 type of severity of AEs.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.|||participants|||Number
1395715|NCT01302938|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety set included all participants who received at least 1 dose of study medication.|||participants|||Number
1395716|NCT01302938|Secondary|Participant Perception Regarding Recommending a Friend to Enter Similar Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 6, “How likely would you be to recommend a friend to enter a similar study?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1395717|NCT01302938|Secondary|Participant Perception Regarding Received Treatment in the Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 5, “What treatment did you think you were on?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1395718|NCT01302938|Secondary|Participant Perception Regarding Cell Phone Diary|PEQ:self-administered, assesses participants perception of trial method. Question4, “How satisfied were you with items?” on scale 1(very easy) to 5(very difficult)- a: teaching video explaining CP use; recording urinations using CP; size of text on CP; sending your urinary information(inf) using your CP, e: overall, suitability for capturing urinations as they happened.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1395719|NCT01302938|Secondary|Participant Perception Regarding Satisfaction Related to Study|PEQ:self-administered, to assess perception of trial method. Question3, “How satisfied were you with items?” on scale 1(very satisfied) to 5(very dissatisfied)- recruitment; questionnaires,surveys(Ques,Sur); identification verification(IV); informed consent(IC) process; website experience; phone call; laboratory(lab) kit delivery; lab location; lab staff service(Ser); physical exam(PE) scheduling,location (sch,loc); PE visit; medication(med) first batch delivery; med second batch delivery; cell phone(CP) received; CP use; call center(CC) ser; medical support(supp); technical supp; overall.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1395720|NCT01302938|Secondary|Number of Participants With Reason for Participation in the Study|PEQ is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 2, “What led you to participate given the study drug is already available?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1395721|NCT01302938|Secondary|Number of Participants With Response Regarding Source of First Information About Study|Participant experience questionnaire (PEQ) is a web-based self-administered, exploratory questionnaire that assesses the participant’s perception of trial method. Number of participants who responded to question 1, “Where did you hear first about the study?” are reported.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1395941|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Periumbilical Region Before the Procedure|The evaluations using the soft brush were performed 2–3 cm from the incision in the periumbilical region (where the large trocar was placed) before the procedure|Before the procedure (Baseline)||||participants|||Number
1395722|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Social Domain Score at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Full Range|Median
1395723|NCT01302938|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains (range): concern(7-42), coping(8-48), sleep(5-30), and social function(5-30). Total HRQL score (25-125) derived as sum of HRQL domains. Transformed score range 0 to 100 (HRQL domain or total) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicate better HRQL.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1395724|NCT01302938|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for items 1 to 8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1395725|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 1, 4 and 12|PPUS: a self-administered, single-item, validated questionnaire that measures the participant’s perception of urinary urgency. It is sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she is doing before going to toilet [without leaking]). Results categorized as SC from baseline on 3-point scale: improvement (positive SC), no change (SC 0), deterioration (negative SC).|Baseline (Bl), Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||participants|||Number
1395726|NCT01302938|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 1, 4 and 12|PPBC: self-administered,single-item questionnaire to describe participant’s perception of bladder-related problems. PPBC assessed on 6-point scale:1=no problems at all,2=some very minor problems,3=some minor problems,4=some moderate problems,5=severe problems,6=many severe problems. Results categorized as score change (SC) from baseline on 2-point scale:improvement (negative SC),no improvement (SC 0 or more) and on 4-point scale:major improvement (SC is negative in magnitude of 2 or more), minor improvement (SC is negative in magnitude of 1), no change (SC= 0),deterioration (positive SC).|Baseline, Week 1, 4, 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using LOCF method. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||participants|||Number
1395727|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of >= 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||episodes per 24 hours||Standard Deviation|Mean
1395728|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 1, 4 and 12|The mean number of micturition-related nocturnal urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 that occurred between time participant went to bed and time participant arose to start next day divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.||||||
1395765|NCT01302548|Primary|Abscess Healing Based on Abscess Measurement Scale|"The abscess healing process will use two methods: 1) usual method includes saline irrigation and/or incision & drainage, and 2) the use of IRRISEPT solution. The Abscess Measurement Scale was measured using a centimeter ruler.~Scale 8cm – 10cm = Severe 6cm – 8cm = Moderate/severe 4cm – 6cm = Moderate 2cm – 4cm = Mild/moderate 0cm – 2cm = Mild"|48 hours||||units on a scale||Standard Deviation|Mean
1395729|NCT01302938|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Week 1, 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 1, 4, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis, as per change in planned analysis.||||||
1395730|NCT01302938|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 1 and 4|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||micturitions per 24 hours||Standard Deviation|Mean
1395731|NCT01302938|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 1, 4 and 12|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||episodes per 24 hours||Full Range|Median
1395732|NCT01302938|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 1, 4 and 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 at that visit. Baseline values for each time point were calculated separately considering only those participants who were evaluable at the given time point.|Baseline, Week 1, 4, 12|FAS population. Missing values imputed using LOCF method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ = number of participants who were evaluable at specific time points for each arm group, respectively.|||milliliter (mL)||Standard Deviation|Mean
1395733|NCT01302938|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine. The mean number of micturitions per 24 hours was calculated as the total number of micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 baseline or post-baseline efficacy assessment. Missing values imputed using Last observation carried forward (LOCF) method. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||micturitions per 24 hours||Standard Deviation|Mean
1395734|NCT01302899|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril||26 weeks|The safety analysis set consisted of all patients who received at least one study drug and had no major protocol deviations that could have impacted safety data.|||Participants|||Number
1395735|NCT01302899|Secondary|Plasma Rennin Concentration (PRC)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395736|NCT01302899|Secondary|Plasma Rennin Activity (PRA)|Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma.|Baseline to week 26|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395737|NCT01302899|Secondary|Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395738|NCT01302899|Secondary|Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395739|NCT01302899|Secondary|Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments||26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395740|NCT01302899|Secondary|Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function|All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395741|NCT01302899|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395742|NCT01302899|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)|At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395743|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395744|NCT01302899|Primary|Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)|Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.|26 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
1395745|NCT01302860|Secondary|Number of Participants With Anti-canakinumab Antibodies at Week 56|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|Week 56 (End of study)|The analysis was performed in the safety set population. Here, ‘Number of participants analysed’ signifies participants who had immunogenicity samples taken and analyzed during the study.|||participants|||Number
1395746|NCT01302860|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|Day -14 (prior-vaccination), Day 0 (vaccination), Day 28, Day 57 (post-vaccination)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies evaluable participants who received a total of 31 vaccinations during the study."|||vaccination cases|||Number
1395747|NCT01302860|Secondary|Percentage of Participants Receiving a Concomitant Vaccination During the Study|Participants received any one of the following inactivated vaccines as per the immunization program: Corynebacterium diphtheria, Bordetella pertussis, Neisseria meningitidis, Clostridium tetani, Influenza type A, Influenza type B, Haemophilus influenza B, Streptococcus pneumoniae, or Hepatitis B were determined.|Day 1 (start of study treatment) to Week 56 (end of study)|The analysis was performed in the FAS population.|||Percentage of participants|||Number
1395748|NCT01302860|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Day 1 (start of study treatment) up to Week 56 (end of study)|The analysis was performed in the safety set population defined as participants who received at least one dose of study drug. Here, ‘n’ signifies participants evaluable for this measure at specified time points for each group, respectively.|||participants|||Number
1395749|NCT01302860|Secondary|Change From Baseline in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations at Week 56|The CRP and SAA were used as inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Baseline, Week 56|The analysis was performed in FAS population. Here ‘n’ signifies those participants with evaluable measurements at both baseline and the post-baseline visit.|||mg/L||Standard Deviation|Mean
1395750|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician Assessment of Skin Disease at Week 56|Participants were assessed by physician for skin disease (urticarial skin rash) measured on a 5-­point scale as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.|||Percentage of participants|||Number
1395751|NCT01302860|Secondary|Percentage of Participants With Defined Grades in Physician’s Global Assessment Score at Week 56|Participants were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Week 56|The analysis was performed in FAS population.|||Percentage of participants|||Number
1395752|NCT01302860|Secondary|Percentage of Participants Aged 2 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as CRP or SAA to be <15 mg/L and <10 mg/L respectively.|Week 56|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants aged 2 years or younger."|||Percentage of participants|||Number
1395766|NCT01302483|Secondary|Maximum Change in Pulse Oximetry From Baseline|Maximum change from Baseline at any time point|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intent to Treat|||SpO2||Standard Deviation|Mean
1395767|NCT01302483|Secondary|Maximum Change in Blood Pressure From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40 50, 60, 120 minutes|Intention to treat|||mmHG||Standard Deviation|Mean
1395768|NCT01302483|Secondary|Maximum Change in Pulse From Baseline|Maximum change from Baseline at any time point.|Baseline, 15, 20, 30, 40, 50, 60, 120 minutes|Intention to treat|||beats per minute||Standard Deviation|Mean
1395753|NCT01302860|Primary|Percentage of Participants Aged 4 Years or Younger With at Least One Complete Response at Week 56|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician global assessment of auto-inflammatory disease activity as absent or minimal (using a 5-point scale ranging from absent to severe) and assessment of skin disease as absent or minimal (using a 5-point scale ranging from absent to severe). Serological remission was defined as C reactive protein (CRP) or Serum amyloid A protein (SAA) to be less than (<) 15 milligram per liter (mg/L) and <10 mg/L respectively.|Week 56|The analysis was performed in Full analysis set (FAS), defined as all participants who received at least one dose of study drug under this study protocol.|||Percentage of participants|||Number
1395754|NCT01302743|Primary|Decrease in LDL Cholesterol|Subjects will have baseline blood levels to measure LDL Cholesterol. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.|90 days|no data was analyzed as study was stopped early due to low recruitment||||||
1395755|NCT01302743|Primary|Decrease in HbA1c|Subjects will have baseline blood levels to measure HbA1c. Subjects will then take either cinnamon bark powder, water-soluble cinnamon extract or metformin for 90 days then blood levels of HbA1c and lipid panel will be drawn again.|90 days|no data was analyzed as study was stopped early due to low recruitment||||||
1395756|NCT01302691|Secondary|Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
1395757|NCT01302691|Primary|Percentage of Participants Who Had Study Drug Stopped Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm|up to 8 weeks|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1395758|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related SAE|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1395759|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1395760|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Drug-related AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1395761|NCT01302691|Primary|Percentage of Participants Who Experience ≥1 Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.|up to 14 days after last dose of study drug (up to 10 weeks)|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1395762|NCT01302691|Primary|Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
1395763|NCT01302548|Secondary|Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.|"The Abscess Measurement Scale was measured using a centimeter ruler.~Scale 8cm – 10cm = Severe 6cm – 8cm = Moderate/severe 4cm – 6cm = Moderate 2cm – 4cm = Mild/moderate 0cm – 2cm = Mild"|48 hours|Only participants that were MRSA-positive, were analyzed.|||units on a scale||Standard Deviation|Mean
1395769|NCT01302483|Secondary|Soft Tissue Anesthesia Duration|"Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were:~Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule~Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule~Site 3: Incisive papilla~Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)"|Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes|Intention to treat|||Minutes||Standard Deviation|Mean
1395770|NCT01302483|Primary|Pulpal Anesthesia|Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.|Continuous throughout dental treatment period (up to 60 minutes)|Intention to treat|||participants|||Number
1395771|NCT01302444|Secondary|Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP)as Assessed by Transthoracic Echocardiography Using Doppler Ultrasound||16 weeks|data not reported for one participant for anonymity||||||
1395772|NCT01302444|Secondary|Plasma BNP (Brain Natriuretic Peptide)Level Change||16 weeks of therapy|data not reported for one participant for anonymity||||||
1395773|NCT01302444|Secondary|Tei Index Change by Transthoracic Echocardiography||16 weeks of therapy|data not reported for one participant for anonymity||||||
1395774|NCT01302444|Secondary|6 Minute Walking Distance Change Will Improve||16 weeks of therapy|data not reported for one participant for anonymity||||||
1395775|NCT01302444|Primary|Hospitalizations||16 weeks|data not reported for one participant for anonymity||||||
1395776|NCT01302444|Primary|WHO Functional Class Will Improve or Remain Stable||16 weeks|data not reported for one participant for anonymity||||||
1395777|NCT01302444|Primary|Adverse Events Are no Greater Than With Treprostinil Infusion Alone||16 weeks|data not reported for one participant for anonymity||||||
1395778|NCT01302444|Primary|All Cause Mortality||16 weeks|data not reported for one participant for anonymity||||||
1395779|NCT01302418|Primary|Detection of Respiratory Viruses|The presence of Influenza A or Influenza B virus.|Specimens will be taken within 5 days of the appearance of symptoms.|All subjects meeting inclusion/ exclusion criteria and who had sufficient specimen volume.|||participants|||Number
1395780|NCT01302392|Secondary|Duration of Disease Control|Duration of Disease Control was calculated for subjects who achieved disease control. Duration of Disease Control was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving disease control through the final analysis data cutoff with longest follow-up time of approximately 31 months.|The intent to treat (ITT) population comprised randomized participants who achieved disease control.|||months||95% Confidence Interval|Median
1395781|NCT01302392|Secondary|Disease Control|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||participants|||Number
1395782|NCT01302392|Secondary|Duration of Clinical Benefit|Duration of Clinical Benefit was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) or minimal response (MR). Duration of Clinical Benefit was defined as the time in months from the initial start of response (MR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From time of achieving clinical benefit through the final analysis data cutoff with longest follow-up time of approximately 30 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of MR or better only.|||months||95% Confidence Interval|Median
1395783|NCT01302392|Secondary|Clinical Benefit Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC). (MR was determined using European Group for Blood and Marrow Transplantation criteria)|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||participants|||Number
1395784|NCT01302392|Secondary|Duration of Response|Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for progression-free survival.|From the time achieving response through the final analysis data cutoff with longest follow-up time of approximately 29 months.|The intent to treat (ITT) population comprised randomized participants who achieved a best overall response of PR or better only.|||months||95% Confidence Interval|Median
1395815|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Standard Error|Least Squares Mean
1395785|NCT01302392|Secondary|Overall Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||participants|||Number
1395786|NCT01302392|Secondary|Progression-free Survival|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the final analysis data cutoff with longest follow-up time of approximately 31 months. Median follow up times were 26.6 months and 23.1 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||months||95% Confidence Interval|Median
1395787|NCT01302392|Primary|Overall Survival|Time elapsed between the randomization date and the date of death. Participants who were still alive were censored at date when the subject is last known alive or the data cutoff date, whichever occurs earlier.|From randomization through the final analysis data cutoff with longest follow-up time of approximately 45 months. Median follow up times were 27.8 months and 29.8 months for Carfilzomib and Best Supportive Care groups, respectively.|The intent to treat (ITT) analysis set comprised all randomized participants.|||months||95% Confidence Interval|Median
1395788|NCT01302366|Primary|Duration of Response (Excluding Patient Choice and Non-compliance)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years|All patients or the patients excluding personal choice or non-compliance|||months||Full Range|Median
1395789|NCT01302366|Secondary|Percentage of Patients Who Have Responded to TBL12|Response to TBL12 is defined as SD or better after 2 cycles of TBL12. The evaluation of SD, PR, or CR is based on the report by Blade et al. (1998)|2 months|all patients|||percentage of participants|||Number
1395790|NCT01302366|Primary|Duration of Response (All Treated Patients)|Response [complete response (CR), partial response (PR), and stable disease (SD)] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).|up to 3 years||||months||Full Range|Median
1395791|NCT01302119|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1395792|NCT01302119|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1395793|NCT01302119|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1395794|NCT01302119|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1395795|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 12.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. Number of participants with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 12.|||Percentage of participants|||Number
1395796|NCT01302067|Secondary|Percentage of Participants Who Became Dry at Week 4.|Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with baseline UUI >0 per 24 hours and non-missing change from baseline to Week 4.|||Percentage of participants|||Number
1395797|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
1395798|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
1395799|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
1395800|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
1395801|NCT01302067|Secondary|Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
1395802|NCT01302067|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.|||Scores on a scale||Standard Error|Least Squares Mean
1395803|NCT01302067|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.|UPS: single-item, self-administered validated questionnaire. Participant answered: “Which of the following would typically describe your experience when you have a desire to urinate?” on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.|||Participants|||Number
1395804|NCT01302067|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.|||Participants|||Number
1395805|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.|||Participant||Full Range|Median
1395806|NCT01302067|Secondary|Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 4.|||Participant||Full Range|Median
1395807|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Standard Error|Least Squares Mean
1395808|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Standard Error|Least Squares Mean
1395809|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Full Range|Median
1395810|NCT01302067|Secondary|Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Full Range|Median
1395811|NCT01302067|Secondary|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Standard Error|Least Squares Mean
1395812|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Full Range|Median
1395813|NCT01302067|Secondary|Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 4|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.|||Episodes per 24 hours||Full Range|Median
1395814|NCT01302067|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.|Micturitions include episodes of voluntary micturition and episodes of UUI.|Week 12|The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.|||Episodes per 24 hours||Standard Error|Least Squares Mean
1396002|NCT01300767|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1395816|NCT01302067|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 12|Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI >0 per 24 hours & non-missing change from BL to Week 12 were included.|||Episodes per 24 hours||Standard Error|Least Squares Mean
1395817|NCT01302054|Secondary|Percentage of Participants With No UUI Episodes (Diary Dry Rate)|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).|||percentage of participants|||Number
1395818|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||percentage of participants|||Number
1395819|NCT01302054|Secondary|Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week -2, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||percentage of participants|||Number
1395820|NCT01302054|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1395821|NCT01302054|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1395822|NCT01302054|Secondary|Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12|UPS: single-item, self-administered validated questionnaire. Participant answered: “Which of the following would typically describe your experience when you have a desire to urinate?” on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||participants|||Number
1395823|NCT01302054|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12|"PPBC: single-item, self-administered validated questionnaire. Participant answered: “Which of the following statements describes your bladder condition best at the moment? on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of >=2)."|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.|||participants|||Number
1395836|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 4 ng/ml|Participants with unknown or missing PSA results at week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25. Participants with unknown or missing PSA results at week 49, 97 and 169 were considered non-responders.|Weeks 25, 49, 97 and 169|Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point|||Percentage of Participants|||Number
1395824|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline urgency episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
1395825|NCT01302054|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 12|FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here ‘N’ (number of participants analyzed): participants with baseline micturitions >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||micturitions per 24 hours||Standard Deviation|Mean
1395826|NCT01302054|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
1395827|NCT01302054|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes >0 per 24 hours and non-missing change from baseline at Week 12(LOCF).|||episodes per 24 hours||Standard Deviation|Mean
1395828|NCT01302041|Secondary|PSA Doubling Time|PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.|From Baseline to Week 25|Safety Analysis Set with a positive PSA versus time slope||||||
1395829|NCT01302041|Secondary|Time to PSA Progression|Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
1395830|NCT01302041|Secondary|Time to PSA ≤ 0.1 ng/ml|"Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded.~Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method."|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
1395831|NCT01302041|Secondary|Time to PSA ≤ 4 ng/ml|Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
1395832|NCT01302041|Secondary|Time to PSA Decline ≥ 90%|Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
1395833|NCT01302041|Secondary|Time to PSA Response|Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.|From first dose until the EOS date of 27-Apr-2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Days||Inter-Quartile Range|Median
1395834|NCT01302041|Secondary|Maximum Decline From Baseline in PSA|The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.|Baseline to Week 25 and from Baseline up to the EOS date of 27 Apr 2017; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395835|NCT01302041|Secondary|Percentage of Participants With PSA ≤ 0.1 ng/ml|Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, 97 or 169 were considered non-responders.|Weeks 25, 49, 97 and 169|Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point|||Percentage of Participants|||Number
1399232|NCT01270542|Secondary|Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.||3 months after last surgery.||||Eyes|Eyes||Count of Units
1395837|NCT01302041|Secondary|Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level|Participants with unknown or missing PSA results at week 25 or who discontinued prior to week 25 were considered non-responders at week 25. Participants with unknown or missing PSA results at week 49, week 97 or week 169 were considered non-responders.|Baseline and Weeks 25, 49, 97 and 169|Safety Analysis Set; Week 49, 97 and 169 analyses include participants who were on study at each time point|||Percentage of Participants|||Number
1395838|NCT01302041|Secondary|Percentage of Participants With a PSA Response at Weeks 49, 97 and 169|A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 49, week 97 or week 169 for any reason were treated as non-responders.|Baseline and Weeks 49, 97 and 169|Safety Analysis Set|||Percentage of Participants||95% Confidence Interval|Number
1395839|NCT01302041|Secondary|Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|Pharmacokinetic Analysis Set with available data at each time point|||μg/mL||Standard Deviation|Mean
1395840|NCT01302041|Secondary|Plasma Concentration of Enzalutamide at Pre-dose (Ctrough)||Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25|Pharmacokinetic Analysis Set (PKAS) (participants who had taken at least 1 dose of study drug and who had at least 1 pharmacokinetic concentration value) with available data at each time point|||μg/mL||Standard Deviation|Mean
1395841|NCT01302041|Secondary|Percent Change From Baseline in Free Testosterone||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395842|NCT01302041|Secondary|Percent Change From Baseline in Total Testosterone||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395843|NCT01302041|Secondary|Percent Change From Baseline in Prolactin||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395844|NCT01302041|Secondary|Percent Change From Baseline in Luteinizing Hormone (LH)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395845|NCT01302041|Secondary|Percent Change From Baseline in Follicle-Stimulating Hormone (FSH)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395846|NCT01302041|Secondary|Percent Change From Baseline in Estradiol||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395847|NCT01302041|Secondary|Percent Change From Baseline in Dihydrotestosterone (DHT)||Baseline and Week 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395848|NCT01302041|Secondary|Percent Change From Baseline in Dehydroepiandrosterone (DHEA)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395849|NCT01302041|Secondary|Percent Change From Baseline in Androstenedione||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395850|NCT01302041|Secondary|Percent Change From Baseline in Sex Hormone-Binding Globulin (SHBG)||Baseline and Weeks 25 and 49|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395851|NCT01302041|Secondary|Percent Change From Baseline in PSA||Baseline and Weeks 25, 49, 97, 169 and Week 265 (End of Study)|Safety Analysis Set with available data at each time point|||Percent Change||Standard Deviation|Mean
1395852|NCT01302041|Secondary|Number of Participants With Adverse Events|"Each adverse event (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs).~A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life-threatening~Resulted in persistent or significant disability/incapacity~Resulted in congenital anomaly or birth defect~Required inpatient hospitalization or led to prolongation of hospitalization~Other medically important events."|From first dose of study drug up to 30 days after last dose of study drug; median duration of treatment of 1666.0 days (range of 52-2052)|Safety Analysis Set|||Participants|||Count of Participants
1395853|NCT01302041|Primary|Percentage of Participants With a Prostate-Specific Antigen (PSA) Response at Week 25|A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to week 25 for any reason were treated as non-responders.|Baseline and Week 25|The analysis population was safety analysis set (SAF), which consisted of participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
1395854|NCT01301963|Secondary|Compare Need for Remobilization Between Mobilization Groups|Using the Chi-square test or Fisher's exact test, as appropriate.|Day 1|||||||
1395855|NCT01301963|Secondary|Compare Need for Hospitalization During Mobilization Between Mobilization Groups||Day 1|||||||
1395856|NCT01301963|Secondary|Compare Days of Apheresis Between Mobilization Groups|Using the Wilcoxon Rand Sum Test|Day 1|||||||
1395857|NCT01301963|Secondary|Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other|Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.|By day 1|||||||
1395858|NCT01301963|Secondary|Percentage of Patients Achieving Target Goal CD34+ Cells Dose||In =< 5 days of leukaphereses|Due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study||||||
1395859|NCT01301963|Primary|Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg||In =< 2 days of leukaphereses|due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study||||||
1395860|NCT01301950|Secondary|To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location||Intraoperative|No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0.||||||
1395862|NCT01301950|Secondary|Turnover Time (Time to Clean Operating Room After Surgery is Completed)|Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes].|Intraoperative (Time to clean Operating Room after surgery is completed)|1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection.|||minutes||Standard Deviation|Mean
1395863|NCT01301950|Secondary|Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete|Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis [minutes]|Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)||||minutes||Standard Deviation|Mean
1395864|NCT01301950|Primary|Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements|Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).|Intraoperative (Time from first incision to first stitch)||||minutes||Standard Deviation|Mean
1395865|NCT01301833|Secondary|Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||μU / mL||Standard Deviation|Mean
1395866|NCT01301833|Secondary|Change From Baseline in Fasting Glucagon at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||pg / mL||Standard Deviation|Mean
1395867|NCT01301833|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||mg / dL||Standard Deviation|Mean
1395868|NCT01301833|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and 52 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||Percent||Standard Deviation|Mean
1395869|NCT01301833|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 Weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.|||participants|||Number
1395870|NCT01301742|Secondary|Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.~The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1395871|NCT01301742|Primary|Total Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.~The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1395872|NCT01301742|Primary|Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.~The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV)."|0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose|PK set: All subjects who had taken at least 1 dose of trial medication who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1395873|NCT01301729|Secondary|Time to Progression|Time to progression was defined as the time from the date of enrollment until the date of progressive disease.|From the date of enrollment until the date of progressive disease (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||months||95% Confidence Interval|Median
1395874|NCT01301729|Secondary|Clinical Benefit Rate|Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||percentage of participants||95% Confidence Interval|Number
1395875|NCT01301729|Secondary|Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses)||up to 28 months|Biomarker analysis was not performed as the eligible biomarker sample quantity was too limited for testing.||||||
1395876|NCT01301729|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.|Up to 28 days after last infusion of the study drug (28 months)|Safety population is defined as all enrolled participants and have taken at least one dose of study drug.|||percentage of participants|||Number
1395877|NCT01301729|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.|Time from enrollment to the date of death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||months||95% Confidence Interval|Median
1395878|NCT01301729|Secondary|Duration of Response|Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions.|From the time of PR or CR until the date of PD or death (up to 28 months)|ITT data set is defined as all the participants who are eligible through screening, register and enter the study. Here, number of participants are the participants who had response.|||months||95% Confidence Interval|Median
1395879|NCT01301729|Secondary|Overall Response Rate|Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.|up to 28 months|ITT data set is defined as all the participants who are eligible through screening, register and enter the study.|||percentage of participants||95% Confidence Interval|Number
1395880|NCT01301729|Primary|Progression-Free Survival (PFS)|PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.|From the date of informed consent to the date of death or progressive disease (up to 28 months)|Intention to treat (ITT) data set is defined as all the participants who are eligible through screening, register and enter the study.|||months||95% Confidence Interval|Median
1395881|NCT01301508|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of study medication and up to the end of study treatment (Day 42) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 42|Safety analysis population included all randomized participants with confirmed usage of the study medication.|||participants|||Number
1395882|NCT01301508|Other Pre-specified|Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 14 and 42|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Days 14, 42 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Days 14, 42 as compared to active lesion (ointment treated) were reported in this outcome measure.|Baseline (Day 1), Day 14, Day 42|ITT population included all randomized participants who received study medication.|||percentage of participants|||Number
1395883|NCT01301508|Primary|Percentage of Participants With Decrease From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 28|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition. Percentage of participants in whom the active lesion (ointment treated) achieved a greater decrease from baseline to Day 28 in ADSI as compared to vehicle lesion (vehicle treated) and, in whom the vehicle lesion (vehicle treated) achieved a greater decrease from baseline to Day 28 as compared to active lesion (ointment treated) were reported in this outcome measure.|Baseline (Day 1), Day 28|ITT population included all randomized participants who received study medication.|||percentage of participants|||Number
1395884|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 42|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 42|ITT population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
1396003|NCT01300767|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1395885|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 28|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 28|ITT population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
1395886|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Day 14|ADSI score was used to measure the severity of participant’s AD affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Day 14|ITT population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
1395887|NCT01301508|Primary|Atopic Dermatitis Severity Index (ADSI) Score at Baseline (Day 1)|ADSI score was used to measure the severity of participant’s atopic dermatitis (AD) affected lesion. It evaluated 5 signs of AD (erythema, pruritus, exudation, excoriation and lichenification) in each lesion. Each sign was rated by investigator on a scale of 0 (none) to 3 (severe), where higher score indicated more severe condition. Total ADSI score for each lesion was sum of scores of the 5 signs and ranged from 0 (none) to 15 (most severe), where higher score indicated more severe condition.|Baseline (Day 1)|The intent-to-treat (ITT) population included all randomized participants who received study medication.|||units on a scale||Standard Deviation|Mean
1395888|NCT01301456|Secondary|Number of Participant With Anti-Drug Antibodies (ADA): Stage 2||Day 1, 29 and 50|Safety population included all participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||participants|||Number
1395889|NCT01301456|Secondary|Number of Participants With Anti-Drug Antibodies (ADA): Stage 1||Day 1 and 29|Safety population included all participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||participants|||Number
1395890|NCT01301456|Secondary|Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2||Baseline, Day 8, 15, 22, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
1395891|NCT01301456|Secondary|Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1||Baseline, Day 8, 15 and 29|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1395892|NCT01301456|Secondary|Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2||Baseline, Day 8, 15, 22, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mcmol/L||Standard Deviation|Mean
1395893|NCT01301456|Secondary|Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1||Baseline, Day 8, 15 and 29|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||micromole per liter (mcmol/L)||Standard Deviation|Mean
1395894|NCT01301456|Secondary|Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2|HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.|Baseline, Day 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent||Standard Deviation|Mean
1395895|NCT01301456|Secondary|Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2|A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.|Baseline, Day 30|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1395896|NCT01301456|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2||Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1395897|NCT01301456|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1||Baseline, Day 2, 4, 6, 15, 22 and 29|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1395919|NCT01301456|Primary|Number of Participants With Clinically Significant Physical Examination Findings|Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1395898|NCT01301456|Secondary|Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3, 15, 24, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng*hr/mL||Standard Deviation|Mean
1395899|NCT01301456|Secondary|Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3 and 8|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng*hr/mL||Standard Deviation|Mean
1395900|NCT01301456|Secondary|Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3, 15, 24, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mU*hr/L||Standard Deviation|Mean
1395901|NCT01301456|Secondary|Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3 and 8|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milliUnit*hour per liter (mU*hr/L)||Standard Deviation|Mean
1395902|NCT01301456|Secondary|Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline, Day 3, 15, 24, 29 and 50|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg*hr/dL||Standard Deviation|Mean
1395903|NCT01301456|Secondary|Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC|Baseline, Day 3 and 8|Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram*hour per deciliter (mg*hr/dL)||Standard Deviation|Mean
1395904|NCT01301456|Secondary|Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2||predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
1395905|NCT01301456|Secondary|Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
1395906|NCT01301456|Secondary|Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2||predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||mL||Geometric Coefficient of Variation|Geometric Mean
1395907|NCT01301456|Secondary|Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1395908|NCT01301456|Secondary|Apparent Clearance (CL/F) of PF-04856883: Stage 2|It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.|predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
1395938|NCT01301079|Secondary|Allodynia as Detected With a Soft Brush in the Thenar Eminence 24 h After the Procedure|The evaluations using the soft brush were performed in the thenar eminence of the non dominant hand 24 h after the procedure|24 h after the procedure||||participants|||Number
1395909|NCT01301456|Secondary|Apparent Clearance (CL/F) of PF-04856883: Stage 1|It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.|predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||milliliter per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
1395910|NCT01301456|Secondary|Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2|Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.|predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1395911|NCT01301456|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1395912|NCT01301456|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||hour||Full Range|Median
1395913|NCT01301456|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1395914|NCT01301456|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22|PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1395915|NCT01301456|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1||predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1|Pharmacokinetic (PK) parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1395916|NCT01301456|Primary|Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements|Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1395917|NCT01301456|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.|Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1395918|NCT01301456|Primary|Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)|ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia’s formula (QTcF interval) and Bazett’s formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1395920|NCT01301456|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.|Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50|The safety population included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1395921|NCT01301274|Secondary|ICU Length of Stay|ICU length of stay (in days)|180 days||||days||Standard Deviation|Mean
1395922|NCT01301274|Secondary|Mechanical Ventilation Free Days at 28 Day of Admission|mechanical ventilation free days at the first 28 day of starting mechanical ventilation, if the patient died the corresponding value is zero.|first 28 day after starting mechanical ventilation||||days||Standard Deviation|Mean
1395923|NCT01301274|Secondary|Mortality at 28 Days|Mortality in both groups will be compared 28 days after admission|28 days after admission|The analysis was per intention to treat|||participants|||Number
1395924|NCT01301274|Primary|Serum Sodium Levels in Both Groups|Mean serum sodium level of each group will be compared at baseline and in the first 48 hours of IV fluid infusion|first 48 hours||||mEq/L||Standard Deviation|Mean
1395925|NCT01301092|Secondary|)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.|||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
1395926|NCT01301092|Secondary|Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part C who had pharmacokinetic (PK) data.|||nanograms*hour/milliliter (ng*h/mL)||90% Confidence Interval|Geometric Mean
1395927|NCT01301092|Primary|Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.|||nanograms/milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
1395928|NCT01301092|Primary|Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)|AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.|Predose up to 336 hours postdose|Participants in Part B who had pharmacokinetic (PK) data.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Geometric Mean
1395929|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
1395930|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 5h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-10 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5h after the procedure||||picogram/milliliter||Standard Deviation|Mean
1395931|NCT01301079|Secondary|Serum Level of Interleukin (IL)-10 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)||||picogram/milliliter||Standard Deviation|Mean
1395932|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
1395933|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
1395934|NCT01301079|Secondary|Serum Level of Interleukin (IL)-8 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-8 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)||||picogram/milliliter||Standard Deviation|Mean
1395935|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 24 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 24 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|24 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
1395936|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 5 h After the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes 5 h after the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|5 h after the procedure||||picogram/milliliter||Standard Deviation|Mean
1395937|NCT01301079|Secondary|Serum Level of Interleukin (IL)-6 Before the Procedure|Blood samples were drawn in ethylenediaminetetraacetic acid (EDTA) tubes before the surgery. The blood was centrifuged to separate the plasma and was stored at -70°C. IL-6 was analyzed using the enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline (Before the procedure)||||picogram/milliliter||Standard Deviation|Mean
1395942|NCT01301079|Secondary|Extension of Hyperalgesia|The 300-g filament was used 24 hours after the operation to induce a stimulus and delineate the extent of hyperalgesia from the periumbilical region. The stimulus was started outside the periumbilical region, where no pain sensation was reported, and continued every 0.5 cm until the 4 points of the periumbilical scar were reached (top, right side, left side, and bottom). The first point where the patient complained of pain was marked. If no pain sensation was reported, the stimulus was terminated 0.5 cm from the incision. The distance of each point from the surgical incision was measured, and the sum of the distances of the points was determined.|24 hours after the procedure||||centimeter||Standard Deviation|Mean
1395943|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure||||kilogram force/second||Standard Deviation|Mean
1395944|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in the Periumbilical Region|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the surgery)||||kilogram force/second||Standard Deviation|Mean
1395945|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|24 h after the procedure||||kilogram force/second||Standard Deviation|Mean
1395946|NCT01301079|Primary|Pain 24 Hours|The scale measure pain after 24 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|24 hours||||units on a scale||Standard Deviation|Mean
1395947|NCT01301079|Primary|Pain 18 Hours|The scale measure pain after 18 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|18 hours||||units on a scale||Standard Deviation|Mean
1395948|NCT01301079|Primary|Pain 12 Hours|The scale measure pain after 12 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|12 hours||||units on a scale||Standard Deviation|Mean
1395949|NCT01301079|Primary|Pain 6 Hours|The scale measure pain after 6 hours (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|6 hours||||units on a scale||Standard Deviation|Mean
1395950|NCT01301079|Primary|Pain 240 Minutes|The scale measure pain after 240 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|240 minutes||||units on a scale||Standard Deviation|Mean
1395951|NCT01301079|Primary|Pain 210 Minutes|The scale measure pain after 210 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|210 minutes||||units on a scale||Standard Deviation|Mean
1395952|NCT01301079|Primary|Pain 180 Minutes|The scale measure pain after 180 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|180 minutes||||units on a scale||Standard Deviation|Mean
1395953|NCT01301079|Primary|Pain 150 Minutes|The scale measure pain after 150 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|150 minutes||||units on a scale||Standard Deviation|Mean
1395954|NCT01301079|Primary|Pain 120 Minutes|The scale measure pain after 120 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|120 minutes||||units on a scale||Standard Deviation|Mean
1395955|NCT01301079|Primary|Pain 90 Minutes|The scale measure pain after 90 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|90 minutes||||units on a scale||Standard Deviation|Mean
1395956|NCT01301079|Primary|Pain 60 Minutes|The scale measure pain after 60 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|60 minutes||||units on a scale||Standard Deviation|Mean
1395957|NCT01301079|Primary|Pain 30 Minutes|The scale measure pain after 30 minutes (0 - without pain and 10 worst pain possible). The individual can choose any number between 0 - 10.|30 minutes||||units on a scale||Standard Deviation|Mean
1395958|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Algometer in Thenar Eminence|The mechanical pain threshold was evaluated using an algometer. The pressure was increased by 0.1 kgf/second until the patient complained of pain. The mean of three determinations was calculated.|Baseline (before the procedure)||||kilogram force/second||Standard Deviation|Mean
1395959|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the postoperative period (24h after the procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24h after the procedure||||gram||Standard Deviation|Mean
1395960|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in the Periumbilical Region|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in the periumbilical region in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)||||gram||Standard Deviation|Mean
1396004|NCT01300767|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1395961|NCT01301079|Secondary|Hyperalgesia in the Postoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the postoperative period (24 hours after procedure). The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|24 hours after procedure||||gram||Standard Deviation|Mean
1395962|NCT01301079|Secondary|Hyperalgesia in the Preoperative Period as Measured With Monofilaments in Thenar Eminence|The pain threshold was assessed using six von Frey monofilaments (0,05 g; 0,2 g; 2 g; 4 g; 10 g e 300 g) in thenar eminence in the preoperative period. The use of different von Frey monofilaments, starting with the lightest and ending with the heaviest, was separated by at least 30 seconds to reduce any anticipated responses due to a new stimulation that was performed too soon after the preceding stimulation. Three assessments were made for each monofilament, and this was considered positive when the patient responded to two of the determinations for each monofilament.|Before the procedure (Baseline)||||gram||Standard Deviation|Mean
1395963|NCT01301079|Secondary|Morphine Consumption Within 24 h||24 hours||||milligram||Standard Deviation|Mean
1395964|NCT01301079|Secondary|Time to First Morphine Supplementation||24 hours||||minutes||Full Range|Median
1395965|NCT01301066|Primary|Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks||12 weeks minus baseline|modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment|||mg/dL||Standard Deviation|Mean
1395966|NCT01301027|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months|The percent difference in IL-6 concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1395967|NCT01301027|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months|The percent difference in TNF-α concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1395968|NCT01301027|Primary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months|The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit and prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1395969|NCT01301027|Primary|Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months|The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm|Baseline and 6 months|1 participant in the Pioglitazone group and 2 participants in the Placebo group had blood samples collected after the 10 week visit prior to their withdrawal. They did not complete the study, but their results were included in the 6-month analysis.|||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
1395970|NCT01301001|Secondary|Vulvodynia Pain|Overall vulvodynia pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). Pain was assessed daily during the last week of treatment. Daily scores were averaged.|Week 6 for each treatment arm||||units on a scale||95% Confidence Interval|Mean
1395971|NCT01301001|Secondary|Coital Pain|Coital pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever), assessed after each sexual intercourse event. The number of sexual intercourse events was averaged during final week of each treatment arm.|Week 6 of each treatment arm|Intent to treat|||units on a scale||95% Confidence Interval|Mean
1395972|NCT01301001|Primary|Tampon Test Pain Intensity|Tampon pain on a 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). One tampon was inserted each week. Tampon pain was assessed during last week of maintenance phase (7 days).|Week 6 for each treatment arm|Intention to Treat|||units on a scale||95% Confidence Interval|Mean
1395973|NCT01300923|Secondary|Brain-derived Neurotrophic Factor (BDNF)|BDNF is a protein that supports the survival of existing neurons and growth and differentiation of new neurons and synapses.|Screen and Week 10||||pg/mL||Standard Deviation|Mean
1395974|NCT01300923|Secondary|Peabody Picture Vocabulary|The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability in standard American English vocabulary. This test has been nationally standardized using examinees from various age groups, from children to adults. Thus, the raw scores are equated to mental age, using the norms obtained from standardization. The total standard scores range from 40 (worse receptive vocabulary) to 160 (better receptive vocabulary). The scores can also be converted to percentile rank.|Week 10||||units on a scale||Standard Deviation|Mean
1395975|NCT01300923|Secondary|Vineland Adaptive Behavior Scales-II (VABS-II) Communication Domain|The VABS-II is a semi-structured interview designed to assess adaptive functioning in communication, daily living, socialization and motor skills. Recognizing that language is a major area of impairment in the study population, the Communication Domain (99 Items from 0-198), in particular the Expressive Subdomain (54 Items from 0-108) are of interest in this study. Items arranged in a developmental sequence are rated on a 3-point scale. Each item is scored from 0 (never performs the behavior) to 3 (usually performs the behavior independently). Higher scores indicate higher adaptive functioning. Differences between Baseline and Week 10 are used as an indicator of change.|Week 10||||units on a scale||Standard Deviation|Mean
1397583|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 4|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.|Week 4|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 4 were analyzed.|||ng/mL||Standard Deviation|Mean
1395976|NCT01300923|Secondary|ADHD Rating Scale 4th Edition|The ADHD Rating Scale is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder. The ADHD Rating Scale-IV is completed by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. The total score can range from 0 to 54, with a higher score indicating greater severity.|Week 10||||units on a scale||Standard Deviation|Mean
1395977|NCT01300923|Secondary|Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD|The Children's Yale-Brown Obsessive Compulsive Scales-Modified (CY-BOCS) is a 5-item, semi-structured clinician rating scale modified designed to rate the current severity of repetitive behavior in children and adolescents with PDD. Once the current repetitive behaviors are identified, they are separately rated on 5 items: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored on a 5-point scale form 0 (least symptomatic) to 4 (most symptomatic). The CY-BOCS yields a Total Score from 0 to 20 and is sensitive to change.|Week 10||||units on a scale||Standard Deviation|Mean
1395978|NCT01300923|Secondary|Social Responsiveness Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment|Week 10||||units on a scale||Standard Deviation|Mean
1395979|NCT01300923|Secondary|The Aberrant Behavior Checklist (ABC)|The Aberrant Behavior Checklist (ABC) is a 58-item rating scale used to assess maladaptive behaviors across five original subscales: Irritability (15 items from 0-45), Social Withdrawal (16 items from 0-48), Stereotypy (7 items from 0-21), Hyperactivity (16 items from 0-48), Inappropriate Speech (4 items from 0-12). Additionally, Social Avoidance, a newly developed four-item subscale (from 0-12) of the ABC that captures core social avoidance aspects of Fragile X Syndrome is reported. All items on the ABC are rated from 0 (not at all a problem) to 3 (the problem is severe in degree). Higher scores indicate greater maladaptive behaviors. Differences between Baseline and Week 10 are used as an indicator of change.|Week 10||||units on a scale||Standard Deviation|Mean
1395980|NCT01300923|Primary|Clinical Global Impression- Severity Scale (CGI-S)|The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Week 10||||units on a scale||Standard Deviation|Mean
1395981|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Miscellaneous (4 questions): range 0 – 48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395982|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Sexual function (2 questions): range 0 – 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395983|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Urinary (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1396113|NCT01299909|Primary|Smoking Abstinence|Self-reported 7-day point-prevalence smoking abstinence (i.e., no smoking in the past 7 days) biochemically confirmed by carbon monoxide breath testing in MTS vs ITS subjects at 24 weeks post quit day.|24 weeks post quit day|analysis was conducted on all randomized participants|||participants|||Number
1395984|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Gastrointestinal tract (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395985|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Attention/Memory (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395986|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Perception/Hallucinations (3 questions): range 0 – 36"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395987|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Mood/Cognition (6 questions): range 0 – 72"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395988|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Sleep/Fatigue (4 questions): range 0-48"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1396005|NCT01300741|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Percent likely to purchase|||Number
1395989|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular|"The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.~The final score is derived from multiplying the severity score and the frequency score.~A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.~The possible min/max final scores per subdomain are calculated as follows:~Range of final score per subdomain: 0 – 12 per question multiplied by the number of questions per subdomain:~Subdomain Cardiovascular (2 questions): range 0 – 24"|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395990|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)|Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395991|NCT01300819|Secondary|Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's Disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change from Baseline to end of Maintenance score indicates improvement.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395992|NCT01300819|Primary|Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score|The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson’s Disease (PD). The severity and frequency of the subject’s nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent [daily or all the time]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.|From Baseline (Day 1) to end of 12-week Maintenance (Day 84)|This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.|||scores on a scale||Standard Deviation|Mean
1395993|NCT01300767|Primary|Purchase Intent|"As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, How likely would you be to purchase these lenses? Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses."|4 weeks||||Percent likely to purchase|||Number
1395994|NCT01300767|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1395995|NCT01300767|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1395996|NCT01300767|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1395997|NCT01300767|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1395998|NCT01300767|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1395999|NCT01300767|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1396000|NCT01300767|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1396001|NCT01300767|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks||||Units on a Scale||Standard Deviation|Mean
1396006|NCT01300741|Primary|Overall Satisfaction|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396007|NCT01300741|Primary|Lens Awareness|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396008|NCT01300741|Primary|Delivers a Healthy, Natural Feeling|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396009|NCT01300741|Primary|Handling at Removal|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396010|NCT01300741|Primary|Handling on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396011|NCT01300741|Primary|Low Light Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396012|NCT01300741|Primary|Daytime Vision|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396013|NCT01300741|Primary|Overall Comfort|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396014|NCT01300741|Primary|Comfort at End of Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396015|NCT01300741|Primary|Comfort During the Day|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1396016|NCT01300741|Primary|Comfort on Insertion|As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses|||Units on a Scale||Standard Deviation|Mean
1396017|NCT01300728|Secondary|Mean Cognitive Performance at 24 Months|"24 month cognitive performance in treatment (IVIG/placebo) is measured by:~Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)~Scale from 0 to 85 (0 is best cognitive performance)~Score is the sum of 12 sub-scales.~Mini Mental State Exam (MMSE)~Scale from 0 to 30 (30 is best cognitive performance)~Score is the sum of 11 sub-scales.~Clinical Dementia Rating - Sum of Boxes (CDR-SB)~Scale is 0 to 18 (0 is best cognitive performance)~Score is the sum of 6 sub-scales"|24 month||||units on a scale||Standard Deviation|Mean
1396018|NCT01300728|Secondary|Mean Cognitive Performance at 12 Months|"12 month cognitive performance in treatment (IVIG/placebo) is measured by:~Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog)~Scale from 0 to 85 (0 is best cognitive performance)~Score is the sum of 12 sub-scales.~Mini Mental State Exam (MMSE)~Scale from 0 to 30 (30 is best cognitive performance)~Score is the sum of 11 sub-scales.~Clinical Dementia Rating - Sum of Boxes (CDR-SB)~Scale is 0 to 18 (0 is best cognitive performance)~Score is the sum of 6 sub-scales"|12 months||||units on a scale||Standard Deviation|Mean
1396019|NCT01300728|Secondary|Change in Ventricular Volume in Patients With Positive Cerebrospinal Fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer Signature|Mean ventricular volume (cubic centimeters) in patients with positive cerebrospinal fluid (CSF) Aβ1-42/CSF P-Tau181P Alzheimer signature at 24 months following infusion|Baseline to 24 months following infusion||||cubic centimeters (cc)||Standard Deviation|Mean
1396036|NCT01300546|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Day 121||||scores on a scale||Standard Deviation|Mean
1396020|NCT01300728|Secondary|Number of Participants Who Converted From Amnestic Mild Cognitive Impairment (a-MCI) to Alzheimer Disease (AD)|The National Institute of Neurological and Communicative Disorders and Stroke - Alzheimers Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria were proposed in 1984 by NINCDS-ADRDA criteria for diagnosing Alzheimer Disease and Clinical Dementia Rating (CDR) will be used to determine conversion from a-MCI to AD.|Baseline to 24 months||||participants|||Number
1396021|NCT01300728|Primary|Annualized Percent Change in Ventricular Volume (APCV) as Measured by MRI|"Change in ventricular volumetric as measured by MRI at baseline, 12, and 24 months following the first infusion of either 0.4 g/kg NewGam or 0.9% saline solution(placebo) every 14 days x 5.~Participants will also be classified as early MCI (EMCI) if baseline CDR-SB is less than 1.5, and late MCI (LMCI) if CDR-SB is greater than or equal to 1.5."|Baseline, 12, and 24 month MRI evaluation|"Annualized Percent Change in ventricular volume (APCV) at 12 and 24 months was computed as:~((12 or 24 month volume) - (Baseline volume))/(Baseline volume)/(Time (years) between Baseline and 12 or 24 month visit)"|||percent change per participant year||Standard Deviation|Mean
1396022|NCT01300650|Other Pre-specified|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||14 days|||||||
1396023|NCT01300650|Other Pre-specified|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||14 days|||||||
1396024|NCT01300650|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)|The Duke Activity Status Index (DASI) is a scale that quantifies patients' ability to perform various tasks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores reflect improved activity or improved heart failure symptoms. Lower scores reflect worsened ability or worsened heart failure symptoms.|14 days||||units on a scale||Inter-Quartile Range|Median
1396025|NCT01300650|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|"The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.~Change in VE/VCO2 slope was calculated as the change in VE/VCO2 slope between baseline and 14 days. We therefore calculated the difference between VE/VCO2 slope measurements that occurred at baseline and at 14 days (change in VE/VCO2 slope = VE/VCO2 slope [day 14] - VE/VCO2 slope [baseline])"|14 days||||(unitless)||Inter-Quartile Range|Median
1396026|NCT01300650|Primary|Median Interval Change From Baseline in Peak VO2|"Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.~The outcome measure time frame was 14 days. This means that change in peak VO2 was calculated as the difference between peak VO2 at baseline and 14 days. To calculate this change, we used the mathematical process of subtraction (change in peak VO2 = Peak VO2 [day 14] - Peak VO2 [baseline])"|14 days||||mL/kg/min||Inter-Quartile Range|Median
1396027|NCT01300624|Secondary|Communicative Effectiveness Ratings|"This questionnaire (Lomas et al, 1989) was provided to persons who communicated with the treatment participant regularly (e.g., a spouse). They rated how well the participant was able to perform on 16 common communication tasks (e.g., participating in a conversation over coffee). They rated each scenario along a line that spanned between the two extremes of ability, from not at all able to as able as before the stroke. The line was 100 mm. To score responses, the place where they bisected the line was measured. An average of their responses across the 16 questions was calculated."|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||units on a scale||Standard Deviation|Mean
1396028|NCT01300624|Secondary|Western Aphasia Battery|Standardized measure of aphasia severity|pre-treatment and post-treatment||||units on a scale||Standard Deviation|Mean
1396029|NCT01300624|Primary|Complete Utterances in Discourse|Sentence in discourse that were relevant to topic and syntactically correct|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||percentage of complete utterances||Standard Deviation|Mean
1396030|NCT01300624|Secondary|Verb Naming|Confrontation of 100 action pictures|pre-treatment and post-treatment||||percentage of correct naming||Standard Deviation|Mean
1396031|NCT01300624|Secondary|Noun Naming|Confrontation naming of 162 objects|pre-treatment and post-treatment||||percentage of correct naming||Standard Deviation|Mean
1396032|NCT01300624|Primary|Untrained Sentence Probes|Picture description with sentences containing untrained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||percentage of correct sentences||Standard Deviation|Mean
1396033|NCT01300624|Primary|Trained Sentence Probe|Picture description task that include trained words.|pre-treatment, post-treatment and 3-months post-treatment (maintenance)||||percentage of correct sentences||Standard Deviation|Mean
1396034|NCT01300559|Primary|Hemoglobin Measurement g/dl|The primary hypothesis was that use of the Aquamantys coagulation system in addition to unipolar cautery results in less intraoperative Hb loss compared with unipolar cautery alone during multilevel spinal decompression and fusion surgery.Intraoperatively, shed blood will be collected into a Cell-saver device. Surgical sponges will be recovered in a container of citrated normal saline. Prior to processing the salvaged blood from the cell-saver device, hemoglobin concentration (g/dL) and volume (dL) of the salvaged blood will be measured, allowing calculation of hemoglobin loss in grams.|At the end of surgery|Based on pilot data, it was estimated that 29 patients per group would provide 90% power with = 0.01 to distinguish such a difference between groups. Therefore, the randomized study was planned for 60 patients.|||hemoglobin g/dl||95% Confidence Interval|Mean
1396035|NCT01300546|Secondary|Percent Change in Headache Days All Treatment Periods Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine headache days||Standard Deviation|Mean
1396037|NCT01300546|Secondary|Migraine Disability Assessment Test (MIDAS)|"Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.||||scores on a scale||Standard Deviation|Mean
1396038|NCT01300546|Secondary|Percent Change of Doses of Study Medication|% change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)]*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.|12 Subjects did not take any triptans (Group A) or NSAIDs (Group B) during Baseline Period and were not included in Matched Pairs analysis of study medication taken.|||percent change of study medication||Standard Deviation|Mean
1396039|NCT01300546|Secondary|Doses of Study Medication|Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||doses of study medication||Standard Deviation|Mean
1396040|NCT01300546|Secondary|Migraine Attacks With 50% Reduction|Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||participants|||Number
1396041|NCT01300546|Secondary|Headache Days With Greater Than 50% Reduction|Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||participants|||Number
1396042|NCT01300546|Secondary|Migraine Duration From Time of Treatment to Pain Free|"% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Percent change=[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine duration||Standard Deviation|Mean
1396043|NCT01300546|Secondary|Migraine Duration From Onset to Pain Free|Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine duration||Standard Deviation|Mean
1396044|NCT01300546|Secondary|Migraine Severity|Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine severity||Standard Deviation|Mean
1396045|NCT01300546|Secondary|Migraine Attacks|Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)]*100%).|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.||||percent change of migraine attacks||Standard Deviation|Mean
1396046|NCT01300546|Primary|Percent Change of Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%).|Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)||||percent change of headache days||Standard Deviation|Mean
1396047|NCT01300455|Secondary|Mean AHI|"Evaluation of the effect of multiple dose administration of suvorexant on~AHI as measured by polysomnography. The AHI is an overall index of OSA severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 1|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction.|||Events per hour||95% Confidence Interval|Least Squares Mean
1396048|NCT01300455|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Sleep stages were determined by polysomnography.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
1396049|NCT01300455|Secondary|Percentage of Total Sleep Time That Arterial SaO2 is Less Than 90%, 85%, and 80%|"Evaluation of the percentage of the night in which SaO2 is less than 90%, less~than 85% and less than 80% following multiple dose administration of~suvorexant and placebo. Total sleep time is the total of all REM and non-REM sleep in a sleep episode."|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Percentage of Total Sleep Time||95% Confidence Interval|Mean
1396050|NCT01300455|Secondary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multidose dose suvorexant on mean SaO2 during total sleep time as measured by pulse oximetry. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 and Day 4|Twenty-four of 26 participants were included in the primary evaluation of Day 1 AHI/SaO2 data; 2 participants had no data due to either not receiving placebo or an equipment malfunction. Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
1396051|NCT01300455|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 13 days|All participants were included in the Safety Population.|||participants|||Number
1396052|NCT01300455|Primary|Number of Participants With an Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.|||participants|||Number
1396053|NCT01300455|Primary|Mean Apnea-Hypopnea Index (AHI)|"Evaluation of the effect of multiple dose administration of suvorexant on~AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr."|Day 4|Twenty-five of 26 participants had Day 4 data; one participant did not receive placebo.|||Events per hour||95% Confidence Interval|Least Squares Mean
1396054|NCT01300351|Secondary|Duration of Clinical Benefit|"Duration of clinical benefit (DoCB) will be evaluated only for patients who have CB, and is defined as the time from the date of randomisation until the date of disease progression or death from any cause, whichever is earlier.~Any patient who has not progressed or died by the date of DCO or who has been lost to follow up will be right censored at the date of their last evaluable disease assessment."|36 months|FAS|||months||Inter-Quartile Range|Median
1396055|NCT01300351|Secondary|Duration of Response|"Duration of response (DoR) will be evaluated only for patients who have an objective response, and is defined as the time from the date of first documentation of objective response (i.e., the initial visit at which CR or PR was recorded) until the date of disease progression or death due to any cause (whichever is earlier). The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR.~Any patient who has not progressed or died by the date of DCO, or who has been lost to follow up, will be right-censored at the date of their last disease assessment."|36 months|Evaluable for Response Set|||months||Inter-Quartile Range|Median
1396056|NCT01300351|Secondary|Clinical Benefit Rate|A clinical benefit (CB) responder is defined as a patient having a best overall response of either CR, PR or SD for at least 24 weeks per RECIST v1.1. As tumour assessments can occur ± 2 weeks of the specified time point, the CBR is defined as the proportion of patients in the FAS who have CB ≥ 22 weeks (or 154 days).|36 months|FAS|||patients|||Number
1396057|NCT01300351|Secondary|Objective Response Rate|The ORR is defined as the proportion of all randomized patients with measurable disease at baseline who have a best objective tumour response of either CR or PR per RECIST v1.1.|36 months|Evaluable for Response Set, included all patients in the FAS with measurable disease at baseline.|||patients|||Number
1396058|NCT01300351|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions, or death (by any cause in the absence of progression). The primary analysis for PFS was the log rank test stratified by last endocrine therapy received prior to fulvestrant (AO vs. AI). The treatment effect was estimated using the HR of 500 mg fulvestrant to 250 mg fulvestrant together with the corresponding 95% CI and p value.|36 months|FAS: all randomised patients and compared the treatment groups on the basis of randomised treatment, regardless of treatment actually received.|||months||Inter-Quartile Range|Median
1396059|NCT01300338|Primary|Mean Change in Diastolic Blood Pressure|Average change in diastolic blood pressure (bottom number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months||||Millimeters of Mercury||95% Confidence Interval|Mean
1396060|NCT01300338|Primary|Mean Change in Systolic Blood Pressure|Average change in systolic blood pressure (top number of blood pressure reading) from baseline to 6 months.|Baseline, 6 months||||Millimeters of Mercury||95% Confidence Interval|Mean
1396061|NCT01300286|Secondary|Cryoprecipitate Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||mL||Standard Deviation|Mean
1396062|NCT01300286|Secondary|Platelet Transfusion||Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline)||||mL||Inter-Quartile Range|Median
1396065|NCT01300286|Primary|Fibrinogen Level Change|Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.|Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline)||||mg/dl||Standard Deviation|Mean
1396066|NCT01300260|Other Pre-specified|Area Under the Insulin Concentration-time Curve (AUC)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUCG data.|||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
1396067|NCT01300260|Secondary|Insulin Maximum Concentration (Cmax)|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.|After glucagon bolus on Day 3 postdose|All participants (healthy or with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmaxG data.|||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
1396068|NCT01300260|Primary|Insulin Area Under the Curve (AUC) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 post dose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(10-180) second response phase data.|||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
1396069|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - Second Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax[10-180]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|10-180 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(10-180) second response phase data.|||picomole per liter (pmol/L)]||95% Confidence Interval|Geometric Mean
1396070|NCT01300260|Primary|Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(0-10) first phase response data.|||picomole times hour per liter (pmol*h/L)||95% Confidence Interval|Geometric Mean
1396071|NCT01300260|Primary|Maximum Insulin Concentration (Cmax) - First Phase Response|On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus [T2DM]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax[0-10]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.|0-10 minutes after dextrose bolus on Day 3 postdose|All participants (healthy and with type 2 diabetes mellitus [T2DM]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(0-10) first response phase data.|||picomole per liter (pmol/L)||95% Confidence Interval|Geometric Mean
1396072|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Recovery|B-cell recovery was defined as CD19 >=0.07×10^9/L, where participants’ CD19 were previously depleted. B-cell recovery was only considered possible when the participant had received the last dose of study treatment.|Follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population|||percentage of participants|||Number
1396073|NCT01300247|Secondary|Percentage of Participants Who Had B-Cell Depletion|B-cell depletion was defined as cluster of differentiation 19 (CD19) <0.07×10^9/L and could occur only after at least one dose of study drug had been administered.|Up to the end of the treatment period, and follow-up at 6 months, 6-12 months and after 12 months up to end of study (up to approximately 4 years)|Safety evaluable population|||percentage of participants|||Number
1396075|NCT01300247|Secondary|Percentage of Participants Who Were Alive and Progression Free|Progressive disease assessed using IWCLL: >=50% increase in the absolute number of circulating lymphocytes to at least 5x10^9/L; Appearance of new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology.|Baseline up to relapse or progression or death from any cause, whichever occurred first, up to end of study (up to approximately 4 years)|Safety evaluable population.|||percentage of participants|||Number
1396076|NCT01300247|Secondary|Duration of Objective Response (DOR), Assessed by the Investigator According to IWCLL Guidelines|DOR for participants with OR: time from first CR, CRi or PR to disease progression (DP), relapse, or death, assessed by the investigator. DP: >=50% increase in lymphocytes to at least 5x10^9/L;new palpable lymph nodes (>15 millimeters [mm] in longest diameter) or any new extra-nodal lesion; >=50% increase in the longest diameter of any previous site of lymphadenopathy; >=50% increase in the enlargement of the liver and/or spleen; transformation to a more aggressive histology. CR:peripheral blood lymphocytes (PBL) <4x10^9/L; no lymphadenopathy; no hepatomegaly or splenomegaly (below relevant costal margin); no symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR: >=50% decrease in PBL, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi: met CR criteria, lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery.|From first documented objective response up to disease progression or relapse or death, whichever occurred first (up to approximately 6 months)|Safety evaluable population.|||percentage of participants||95% Confidence Interval|Number
1396077|NCT01300247|Secondary|Percentage of Participants With Objective Response, Assessed According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guidelines|Objective response was defined as a complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR), as determined by investigator. CR:required peripheral blood lymphocytes <4x10^9/L; absence of lymphadenopathy; no hepatomegaly or splenomegaly by physical examination as determined by measurement below relevant costal margin; absence of disease/constitutional symptoms; bone marrow at least normocellular for age, with <30% of nucleated cells being lymphocytes. PR:Greater than equal to (>=) 50% decrease in peripheral blood lymphocyte count, >=50% reduction in lymphadenopathy, >=50% reduction of liver and/or spleen enlargement, either neutrophil, platelet, or hemoglobin (Hb) recovery. CRi:met all CR criteria including confirmed lymphocyte infiltration <30%; may not meet Hb, platelet or neutrophil count recovery. The 95% confidence interval (CI) was estimated by Clopper-Pearson method. The end of treatment response visit occurred 2-3 months after end of treatment.|Baseline up to relapse or progression or death from any cause, whichever occurred first up to end of treatment response visit (up to approximately 9 months)|Safety evaluable population|||percentage of participants||95% Confidence Interval|Number
1396078|NCT01300247|Secondary|Half-Life of Obinutuzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
1396079|NCT01300247|Secondary|Volume of Distribution of Obinutuzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
1396080|NCT01300247|Secondary|Clearance of Obinutuzumab|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on C1D1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
1396081|NCT01300247|Secondary|Trough Plasma Concentration (Ctrough) of Obinutuzumab||Pre-dose on C1D1, C1D3, 8, 15, C2D1, C4D1, C6D1|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
1396082|NCT01300247|Secondary|Maximum Plasma Concentration (Cmax) of Obinutuzumab||Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The PK variables could not be calculated as the PK samples were not collected accurately.||||||
1396083|NCT01300247|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Obinutuzumab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose on Cycle (C) 1 Day (D) 1, immediately after end of infusion (0.5 hour), 0.5 hour of split dose of C1D2, pre-dose and immediately after end of infusion on C1D3, 8, 15, C2D1, C4D1, C6D1 and at progression (up to 1.75 year overall)|The pharmacokinetic (PK) variables could not be calculated as the PK samples were not collected accurately.||||||
1396084|NCT01300247|Primary|Number of Participants With Human Anti-Human Antibodies (HAHAs)||Cycle 1 Day 1 (cycle length = 28 days) up to clinical data cutoff date 24 January 2013 (up to approximately 1.75 years)|Safety evaluable population|||participants|||Number
1396085|NCT01300234|Secondary|Number of Participants in the Indicated Category for Renal Laboratory Abnormalities|"The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter, G= Grade."|Up to Week 240|Safety Analysis Population|||Participants|||Number
1396114|NCT01299896|Primary|Effectiveness of CTQ vs UC|We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine <10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.|Two (2) year period||||percentage of participants per arm|||Number
1396086|NCT01300234|Secondary|Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus|The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Serum creatinine: Grade 1, > 133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, >177 to 265 µmoles/Liter, Grade 3, >265 to 530 µmoles/Liter, Grade 4, >530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to <0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to <0.63 mmoles/L, Grade 4, <0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmoles/L; the upper limit for a Grade 2 abnormality is 0.80 mmoles/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range. NA indicates the value was not available for the indicated time point.|Up to Week 240|Safety Analysis Population|||Participants|||Number
1396087|NCT01300234|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)|TE grade 3 or grade 4 LAs are defined as values that increase by >=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Laboratory parameters assessed included Sodium for hyponatremia and hypernatremia; Potassium for hypokalemia and hyperkalemia; glucose for hypoglycemia and hyperglycemia non-fasting; Phosphate for hypophosphatemia; alanine aminotransferase/aspartate aminotransferase, bilirubin, creatinine kinase, hemoglobin, platelets, neutrophils, lymphocytes, prothrombin time and amylase.|Up to Week 240|Safety Analysis Population|||participants|||Number
1396088|NCT01300234|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Participants with any non-serious AEs and SAEs has been reported.|Up to Week 240 treatment period and 24 weeks follow-up visit off treatment|Safety Analysis Population: All participants who received at least one dose of study medication and had at least one post-Baseline safety assessment|||Participants|||Number
1396089|NCT01300234|Secondary|Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240|"The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Weeks 48, 96, 144, 192 and 240 were assessed. Virological breakthrough is defined by >= one log increase in HBV DNA from NADIR (as determined by two sequential HBV DNA measurements at least one month apart or last on treatment measurement). A non-completers equal failures approach was used for the analysis in ITT population."|Weeks 48, 96, 144, 192 and 240|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
1396090|NCT01300234|Secondary|Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240|"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A non-completers equal failures approach was used for the analysis in ITT population."|Week 96 to Week 240|ITT Population.|||Participants|||Number
1396091|NCT01300234|Secondary|Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48|"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A non-completers equal failures approach was used for the analysis in ITT population."|Week 24 to Week 48|ITT Population. Only those participants available at the indicated time points were assessed.|||Participants|||Number
1396092|NCT01300234|Secondary|Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240|HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240.|Weeks 24, 48, 96, 144, 192 and 240|ITT Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Number
1396093|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240|HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240.|Weeks 24, 48, 96, 144, 192 and 240|ITT Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Number
1396094|NCT01300234|Secondary|Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240.|HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240.|Weeks 24, 48, 96, 144, 192 and 240|ITT Population. Only those participants with data available at specific time point were analyzed|||Participants|||Number
1396102|NCT01300052|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant’s usual function b) moderate =AEs interfered to some extent with participant’s usual function c) severe =AEs interfered significantly with participant’s usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication.|||adverse events|||Number
1396095|NCT01300234|Secondary|Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2.|Histological improvement is defined as a reduction of >=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS >=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 [best] to 14 [worst]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation.|Baseline; Week 48 and Week 240|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
1396096|NCT01300234|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline|"Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter [U/L]). Values at Day 0 were considered as Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Baseline; Weeks 48, 96, 144, 192 and 240|ITT Population.|||Participants|||Number
1396097|NCT01300234|Secondary|Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240|"Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Baseline, Weeks 48, 96, 144, 192 and 240|ITT Population.|||log10 copies/mL||Standard Deviation|Mean
1396098|NCT01300234|Secondary|Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240|"The number of participants with HBV DNA <400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Weeks 96, 144, 192, and 240|ITT Population|||Participants|||Number
1396099|NCT01300234|Primary|Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48|"The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed."|Week 48|Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of study medication.|||Participants|||Number
1396100|NCT01300052|Secondary|Number of Participants With Local Tolerability Symptoms: Pruritus|Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1396101|NCT01300052|Secondary|Number of Participants With Local Tolerability Symptoms: Burning/Stinging|Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1396103|NCT01300052|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|Baseline (Day 1) up to Day 84|Safety population included all randomized participants with confirmed usage of the study medication.|||participants|||Number
1396104|NCT01300052|Secondary|Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84|Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported.|Baseline (Day 1), Day 84|ITT population included all randomized participants who received the study medication. Missing data was imputed using LOCF method.|||percentage of body surface area||Standard Deviation|Mean
1396105|NCT01300052|Secondary|Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70|PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of ‘0 = clear’ or ‘1 = almost clear’, with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70.|Day 14, Day 28, Day 42, Day 56, Day 70|ITT population included all randomized participants who received the study medication.|||percentage of participants||95% Confidence Interval|Number
1396106|NCT01300052|Primary|Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84|PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of ‘0 = clear’ or ‘1 = almost clear’, with at least 2-grade improvement in PGA from Baseline to Day 84.|Day 84|ITT population included all randomized participants who received the study medication. Missing data was imputed using last observation carried forward (LOCF) method.|||percentage of participants||95% Confidence Interval|Number
1396107|NCT01299961|Secondary|12 Month Change in Gray-scale Ultrasound (GSUS)|There were seven different joints in the hands and wrists evaluated to score the GSUS.|baseline, 12 months||||units on a scale||Standard Deviation|Mean
1396108|NCT01299961|Secondary|12 Month Change in Power Doppler Ultrasound (PDUS) Scores|There were seven different joints in the hands and wrists evaluated to score the PDUS.|baseline, 12 months|As stated previously|||units on a scale||Standard Deviation|Mean
1396109|NCT01299961|Primary|12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score|The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.|baseline, 12 months|Total of 19 patients completed 12 mos|||units on a scale||Standard Deviation|Mean
1396110|NCT01299909|Secondary|Perceived Stress Scale (PSS)|"The Perceived Stress Scale (PSS) is a self-report measure of perceived stress; the version used is a 10-item version. Each item is rated on a 0 to 4 scale with 0=Never and 4=Very Often. The minimum score is 0 and the maximum score is 40. Higher scores on the PSS reflect higher levels of perceived stress (a worse outcome).~More information on the PSS can be found in the following article:~Leung, D. Y., Lam, T. H., & Chan, S. S. (2010). Three versions of Perceived Stress Scale: Validation in a sample of Chinese cardiac patients who smoke. BMC Public Health, 10, 513–519"|24 weeks post-quit|Data are derived only from participants who completed all three study assessment visits|||units on a scale||Standard Deviation|Mean
1396111|NCT01299909|Secondary|Acceptance and Action Questionnaire (AAQ)|"The Acceptance and Action Questionnaire (AAQ) is a 9-item self-report measure of experiential avoidance. Each item is rated on a 1 to 7 scale with 1=Never true and 7=Always true; responses are summed and then divided by 9 (the number of items). The minimum score is 1 and the maximum score is 7. Higher scores equal greater levels of experiential avoidance or psychological inflexibility (a worse outcome).~More information on the AAQ can be found in the following two articles:~Hayes, S. C., Strosahl, K., Wilson, K. G., Bissett, R. T., Pistorello, J., Toarmino, D., et al. (2004). Measuring experiential avoidance: A preliminary test of a working model. The Psychological Record, 54(4), 553–578.~Boelen, P. A., & Reijntjes, A. (2008). Measuring experiential avoidance: Reliability and validity of the Dutch 9-item Acceptance and Action Questionnaire (AAQ). Journal of Psychopathology and Behavioral Assessment, 30, 241–251."|24 weeks post-quit|Data are derived only from participants who completed all three study assessment visits|||units on a scale||Standard Deviation|Mean
1396112|NCT01299909|Secondary|Five Facet Mindfulness Questionnaire (FFMQ)|"The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report questionnaire that assesses various components of mindfulness. Each item is rated on a 1 to 5 scale with 1=never or very rarely true and 5=very often or always true; responses are summed and then divided by 39 (the number of items). Higher scores on the FFMQ reflects a higher level of mindfulness (a better outcome).~More information on the FFMQ is available in the following two articles:~Baer, R. A., Smith, G. T., Hopkins, J., Krietemeyer, J., & Toney, L. (2006). Using self-report assessment methods to explore facets of mindfulness. Assessment, 13(1), 27–45, http://dx.doi.org/10.1177/1073191105283504.~Baer,R. A., Smith,G. T., Lykins, E., Button,D., Krietemeyer, J., Sauer, S., et al. (2008). Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment, 15(3), 329–342, http://dx.doi.org/10.1177/1073191107313003."|24 weeks post-quit|Data are derived only from participants who completed all three study assessment visits|||units on a scale||Standard Deviation|Mean
1396115|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
1396116|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Cerebrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng/mL||Standard Deviation|Mean
1396117|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng*hr/mL||Standard Deviation|Mean
1396118|NCT01299805|Primary|Time to Maximum Concentration of 5-HIAA in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
1396119|NCT01299805|Primary|Maximum Concentration of 5-HIAA in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1|Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng/mL||Standard Deviation|Mean
1396120|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma|Area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.|Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||ng*hr/mL||Standard Deviation|Mean
1396121|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
1396122|NCT01299805|Primary|Maximum Concentration of 5-HT in Cerobrospinal Fluid|The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg/mL||Standard Deviation|Mean
1396123|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg*hr/mL||Standard Deviation|Mean
1396124|NCT01299805|Primary|Time to Maximum Concentration of 5-HT in Plasma|The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||hours||Standard Deviation|Mean
1396125|NCT01299805|Primary|Maximum Concentration of 5-HT in Plasma|The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg/mL||Standard Deviation|Mean
1396126|NCT01299805|Primary|Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma|The area under the effect-time curve from time 0 to 24 hours postdose (AUEC[0-24]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).|Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.|"The pharmacodynamic (PD) set consisted of all participants in the safety set with sufficient plasma or serum or CSF data for derivation of at least 1 PD parameter. If a patient's concentration profile contained ≤3 data points, the PD parameter results were not included. n indicates the number of patients with available data at each time point."|||pg*hr/mL||Standard Deviation|Mean
1396127|NCT01299610|Secondary|Pharmacodynamics Endpoint: Skin Thickness and Other Markers of Atopic Dermatitis|A 4 millimeter (mm) punch skin biopsy was taken pre- and post-treatment (Day 1 and Day 21) from each of the 3 index lesions. The results were not analyzed for this outcome measure.|Day 1 and Day 22|Efficacy Population||||||
1396128|NCT01299610|Secondary|Pharmacokintics Parameter: Area Under Curve (AUC) of GW870086|The area under the plasma concentration-time curve to the last quantifiable concentration (AUC[0-t]) and area under the plasma concentration-time curve over the dosing interval (AUC[0-tou]) was planned to be determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher.|Day 7, 14 and 21|Pharmacokinetics population. AUC was not analyzed because the plasma concentrations were not quantifiable.||||||
1396129|NCT01299610|Secondary|Pharmacokinetic Parameter: Time of Occurrence of Cmax (Tmax) of GW870086|Tmax was planned to be determined directly from the raw concentration-time data. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher.|Day 7, 14 and 21|Pharmacokinetics population. Tmax was not analysed because the plasma concentrations were not quantifiable.||||||
1396130|NCT01299610|Secondary|Pharmacokinetic Parameters: Maximum Observed Concentration (Cmax) of GW870086X|Cmax was planned to be determined directly from the raw concentration-time data. The pharmacokinetic parameters were planned to be calculated by standard non-compartmental analysis using Win-Nonlin Pro-Version 5.2 or higher.|Day 7, 14 and 21|Pharmacokinetic population was defined as participants in the All Subjects population for whom a pharmacokinetic sample was obtained and analyzed. Cmax was not analysed because the plasma concentrations were not quantifiable.||||||
1396131|NCT01299610|Secondary|Number of Participants With Abnormal Vital Signs (Systolic and Diastolic Blood Pressure and Pulse Rate) of PCI|The PCI ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of PCI was reported are summarized. There were no values of PCI in vital signs parameters over the course of the study.|Up to Day 21|All subject population|||Participants|||Count of Participants
1396132|NCT01299610|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) of PCI|12-lead ECG was obtained. The standard ECG criteria of PCI were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) increase from Baseline in QTc > 60 msec 3) absolute PR Interval, <110 and >220 msec, 4) absolute QRS Interval, < 75 and >110 msec. The number of participants with PCI ECG findings at any visit during the treatment and follow-up were reported.|Up to Day 21|All subject population|||Participants|||Count of Participants
1396133|NCT01299610|Secondary|Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI)|Laboratory ranges of PCI represented as multiplier of lower limit of normal [LLN]; Multipliers of upper limit of normal (ULN). Laboratory ranges of PCI for white blood cell count (0.67×LLN; 1.82×ULN), neutrophil count (0.83×ULN), hemoglobin for male (1.03×ULN) and for female (1.13×ULN), hematocrit for male (1.02×ULN) for female (1.17×ULN), platelet count (0.67×LLN; 1.57), lymphocytes (0.81×LLN), albumin (0.86 ×LLN), calcium (0.91×LLN; 1.06×ULN), glucose (0.71×LLN; 1.41×ULN), potassium (0.86×LLN; 1.10×ULN), sodium (0.96×LLN; 1.03×ULN), aspartate amino transferase (>= 2x ULN), alanine transaminase (>=2x ULN), alkaline Phosphatase (>=2x ULN), total bilirubin (>=1.5x ULN). Only those parameters for which at least one value of PCI was reported are summarized. The number of participants with PCI hematology and clinical chemistry findings at any visit during the treatment and follow-up were reported.|Up to Day 21|All subject population|||Participants|||Count of Participants
1396144|NCT01299571|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|6 months|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments|||participants|||Number
1396134|NCT01299610|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Number of participants with AEs and SAEs were reported.|Upto Day 21|All Subjects Population was defined as all participants who had at least one application of placebo, GW870086X 0.2%, GW 870086X 2% or FP 0.05% cream.|||Participants|||Count of Participants
1396135|NCT01299610|Secondary|Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22|Three target lesions were selected and each of the 3 target lesions were assessed separately using the IGA. The IGA was carried out by a trained dermatologist and score ranged from 0 to 5. The detailed IGA scale is as: 0-Clear: No inflammatory signs of atopic dermatitis, 1- Almost clear: Just perceptible erythema and just perceptible apulation/infiltration, 2-Mild: Mild erythema and mild papulation/infiltration, 3-Moderate: Moderate erythema, and moderate papulation/infiltration, 4-Severe: Severe erythema and severe papulation/infiltration, 5-Very Severe: Very severe erythema, and very severe papulation/infiltration with oozing/crusting. The participant was considered as responder if each lesion at timepoint, IGA score reduced by 1 grade and improved from Baseline by 2 grades.|Days 2, 3, 7, 14 and 22|Efficacy population|||Participants|||Count of Participants
1396136|NCT01299610|Secondary|Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14|Three target lesions were selected and each of the 3 target lesions were assessed separately using the TIS for erythema, oedema/papulation, and excoriation using a score of 0 - 3 as 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Each participant had at least 3 index lesions (=> 1square centimeter in size) with a sum score of =>4 and =< 6 for erythema, oedema/populations and excoriations using the TIS rating scale at screening. The index lesions represented common lesions i.e. not the most or least severe lesions. The total TIS score for a lesion was calculated as the sum of each of the component scores i.e. may range from 0 (no symptoms) to 9 (severe symptoms). The values of Day 1 assessments were considered as Baseline values. The change from Baseline was calculated by subtracting the Baseline TIS score from Day 22 values TIS score.|Days 2, 3, 7, and 14|Efficacy Population|||Score on scale||Standard Error|Least Squares Mean
1396137|NCT01299610|Primary|Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22|Three target lesions were selected and each of the 3 target lesions were assessed separately using the TIS for erythema, oedema/papulation, and excoriation using a score of 0 - 3 as 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Each participant had at least 3 index lesions (=> 1square centimeter in size) with a sum score of =>4 and =< 6 for erythema, oedema/populations and excoriations using the TIS rating scale at screening. The index lesions represented common lesions i.e. not the most or least severe lesions. The total TIS score for a lesion was calculated as the sum of each of the component scores i.e. ranging from 0 (no symptoms) to 9 (severe symptoms). The values of Day 1 assessments were considered as Baseline values. The change from Baseline was calculated by subtracting the Baseline TIS score from Day 22 TIS score.|Baseline (Day 1) and Day 22|The Efficacy Population was defined as participants in the ‘All Subjects’ population with at least one post dose TIS assessment.|||Score on scale||Standard Error|Least Squares Mean
1396138|NCT01299584|Secondary|Number of Participants With the Indicated Unexpected Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.|24 hours|ITT Population|||participants|||Number
1396139|NCT01299584|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population|||participants|||Number
1396140|NCT01299584|Secondary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled Other (Non-Serious) Adverse Events in the Adverse Event section of the results record."|24 hours|ITT Population|||participants|||Number
1396141|NCT01299584|Primary|Number of Participants With an Unexpected Serious Adverse Event|A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.|24 hours|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments|||participants|||Number
1396142|NCT01299571|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|6 months|ITT Population|||participants|||Number
1396143|NCT01299571|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|6 months|ITT Population|||participants|||Number
1396145|NCT01299480|Other Pre-specified|Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer||1 month after Injection 2, 3, 4|Results were not reported because a decision was made a priori that, although the fold rise outcome measure will still be performed, it will not be performed as a secondary outcome measure. Therefore it was moved from a secondary outcome measure in an earlier protocol version to an exploratory outcome measure in the final protocol.||||||
1396146|NCT01299480|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Injection 1, 1 Month after Injection 2, 3, 4||||percentage of participants|||Number
1396147|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ||Before Injection 1, 1 Month after Injection 2, 3, 4||||percentage of participants|||Number
1396148|NCT01299480|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)||Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4||||titer||95% Confidence Interval|Geometric Mean
1396149|NCT01299480|Secondary|Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants||1 month after Injection 4||||percentage of participants|||Number
1396150|NCT01299480|Primary|Percentage of Participants Reporting At Least 1 Adverse Event (AE)||Injection 1 up to 1 month after Injection 4|Some participants randomized to receive vaccination as per Groups 1, 2 or 4 schedules actually received vaccination as per Group 3 schedule. One participant was not randomized but received Saline at Injection 1 and was included in Group 5. Participants have been presented as per actual administration schedule received.|||percentage of participants|||Number
1396151|NCT01299480|Primary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants||1 month after Injection 4||||percentage of participants|||Number
1396152|NCT01299454|Secondary|Incidence of Suicidality, Suicidal Behaviour or Suicidal Ideation as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The Baseline version of the C-SSRS was administered at Screening. The Since Last Visit version of the C-SSRS was administered on Day 1 at predose and on Days 4 and 7.|Day 1, Day 4, Day 7|Suicidality, suicidal behaviour or suicidal ideation are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participants|||Number
1396153|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Serum Chemistry, Hematology and Urinalysis Parameters.|Hematology, serum chemistry, and urinalysis, including prothrombin time, international normalized ratio, partial thromboplastin time, and activated partial thromboplastin time, were completed at Screening, Day -1, Day 3 (48 hours postdose), and Day 8 (168 hours postdose)/ET.|Day -1 to Day 8|The abnormal values of laboratory values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participant|||Number
1396154|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Parameters.|Electrocardiograms were performed at Screening, Day -1, and Day 1 at predose (in triplicate; within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Standard 12-lead ECGs were performed after the subject was supine and at rest for ≥ 10 minutes prior to the ECG.|Day-1 to Day 8|The abnormal values of ECG values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participants|||Number
1396155|NCT01299454|Secondary|Number of Participants With Changes From Baseline in Vital Signs Parameters.|Vital signs (including blood pressure, heart rate, temperature, and respiratory rate) were assessed at Screening, Day -1, Day 1 at predose (within 45 minutes prior to dosing), and 2, 4, 6, 8, 12, 24, 72, 120, and 168/ET hours postdose. Blood pressure and heart rate were taken with the subject in the supine (performed first), sitting, and standing|Day -1 to Day 8|The abnormal values of vital signs values in participants are captured as serious AEs/AEs and are reported in the SAE or other AE section of this results report.|||Participants|||Number
1396156|NCT01299454|Secondary|Number of Adverse Events (AEs) Reported|AEs were captured for all participants from the time the ICF was signed until the end of the study|From the time the Informed Consent Form was signed, throughout the 8 day study up to 30 days after study drug administration.|Participants who received at least one dose of study drug were included in the safety analysis.|||Events|||Number
1396157|NCT01299454|Secondary|CLr for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
1396158|NCT01299454|Secondary|fe,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||% metabolite excreted in urine||Standard Deviation|Mean
1396159|NCT01299454|Secondary|Ae,u for DM-3411 Metabolite|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng||Standard Deviation|Mean
1396160|NCT01299454|Secondary|t1/2,z for DM-3411 Metabolite|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The t1/2,z was determined as (ln2)/λz."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Standard Deviation|Mean
1396161|NCT01299454|Secondary|Tmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Tmax is the time taken to reach highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Full Range|Median
1396162|NCT01299454|Secondary|Cmax for DM-3411 Metabolite|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET. Cmax is the highest measured concentration of the metabolite during the dosing interval.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
1396163|NCT01299454|Secondary|AUC∞ for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The AUC∞ were estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
1396164|NCT01299454|Secondary|AUCt for DM-3411 Metabolite|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)~The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
1396165|NCT01299454|Secondary|Fraction of Systemically Available Brexpiprazole Excreted Into the Urine (fe,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose..~The value of fe,u was calculated as 100 × Ae,u/Dose."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||% of drug in urine||Standard Deviation|Mean
1396166|NCT01299454|Secondary|Cumulative Amount of Brexpiprazole Excreted Into the Urine (Ae,u)|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of Ae,u was calculated as the summation of urine concentration × urine volume from each collection interval"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng||Standard Deviation|Mean
1396167|NCT01299454|Secondary|Renal Clearance (CLr) of Brexipiprazole|"Urine samples were taken at pre-dose and during the following increments: 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose.~The value of CLr was calculated as Ae,u/AUCt."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
1396168|NCT01299454|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The t1/2,z was determined as (ln2)/λz.~Terminal-phase elimination half-life is the time measured for the plasma concentration to decrease by one half."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Standard Deviation|Mean
1396169|NCT01299454|Secondary|Apparent Unbound Clearance of Brexpiprazole From Plasma After Extravascular Administration (CLu/F)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~The value of CLu/F (brexpiprazole only) was determined as dose normalized unbound area under the concentration-time curve from time zero to infinity (Dose/AUC∞,u)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
1396170|NCT01299454|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu)|Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||% unbound drug in the urine||Standard Deviation|Mean
1396171|NCT01299454|Secondary|Apparent Clearance of Brexpiprazole From Plasma After Extravascular Administration (CL/F)|"The value of CL/F (brexpiprazole only) was determined as Dose/AUC∞.~Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
1396172|NCT01299454|Secondary|Time to Cmax of Brexiprazole (Tmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.~Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||h||Full Range|Median
1396173|NCT01299454|Secondary|Maximum Plasma Concentration of Brexpiprazole (Cmax)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Cmax is the highest measured concentration of the drug during the dosing interval.~Actual blood sample times were used for PK calculations. Values for Cmax and tmax were determined directly from the observed data."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
1396174|NCT01299454|Secondary|Area Under the Concentration Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).~The AUC∞ was estimated using the linear trapezoidal rule"|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
1396267|NCT01298661|Secondary|"First Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
1396175|NCT01299454|Secondary|Area Under the Curve of Brexpiprazole Calculated to the Last Observable Concentration at Time t (AUCt)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUCt= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) The AUCt was estimated using the linear trapezoidal rule."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
1396176|NCT01299454|Primary|Unbound Maximum Plasma Concentration of Brexpiprazole (Cmax,u)|"Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~Cmax,u is the highest measured unbound plasma concentration during the dosing interval."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
1396177|NCT01299454|Primary|Unbound Brexpiprazole AUC Calculated From Time Zero to Infinity (AUC∞,u)|"Blood samples were taken at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/ET.~AUC (0 - ∞)= AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞)."|Day 1 to Day 8|PK set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
1396178|NCT01299454|Primary|Unbound Brexpiprazole Area Under the Concentration Time Curve (AUC) Calculated to the Last Observable Concentration at Time t (AUCt,u)|Blood samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose/Early termination (ET).|Day 1 to Day 8|Pharmacokinetics (PK) set consisting of all evaluable brexpiprazole PK parameters from enrolled particpants who had evaluable plasma concentrations.|||nanograms.hours/mL (ng*h/mL)||Standard Deviation|Mean
1396179|NCT01299389|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation|General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1396180|NCT01299389|Secondary|Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation|Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1396181|NCT01299389|Secondary|Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation|Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1396182|NCT01299389|Secondary|Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28, higher score indicates greater severity.|Baseline and Week 13 or early discontinuation (ED)|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1396183|NCT01299389|Secondary|Participants With Response to the Treatment as Per PANSS Total Score.|Participants with response were defined as those participants who shows 30 percent or more and 20 percent or more reduction in PANSS total score.|up to Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||participants|||Number
1396184|NCT01299389|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 13 or early discontinuation|FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.|||units on a scale||Full Range|Median
1396185|NCT01299389|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13 or early discontinuation|Full Analysis Set (FAS) population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Deviation|Mean
1396186|NCT01299376|Secondary|Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period|Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
1396187|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during extension period.|||Percentage of Participants|||Number
1396188|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
1396189|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More SAEs- Long Term|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
1396190|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
1396191|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized.|Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5|All randomized participants who received at least 1 dose of study drug during long-term reporting period.|||Percentage of Participants|||Number
1396192|NCT01299376|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
1396193|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
1396210|NCT01299272|Secondary|Change From Randomization in Blood Pressure at Week 44 (Double-blind Randomized Withdrawal Period)|Blood pressure measurements were taken 3 times at each visit in a sitting position. The average of the 3 values was used for analysis. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline and baseline-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1396194|NCT01299376|Primary|Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period|An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
1396195|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
1396196|NCT01299376|Primary|Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received.|up to Week 8|All randomized participants who received at least 1 dose of study drug during double-blind treatment period.|||Percentage of Participants|||Number
1396197|NCT01299376|Primary|Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period|Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.|Baseline and Week 8|All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data|||mmHg||95% Confidence Interval|Least Squares Mean
1396198|NCT01299285|Secondary|Percentage of Total Radioactivity of LY3009104 and LY3009104 Metabolites in Plasma||Baseline up to 24 hours|Participants who took study drug.|||percentage of total radioactivity|||Number
1396199|NCT01299285|Secondary|Percentage of Dose of LY3009104 and LY3009104 Metabolites in Feces|Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the feces are reported. Only those metabolites that were detectable in the feces are included in the report.|Baseline up to 72 hours|Participants who took study drug.|||percentage of dose|||Number
1396200|NCT01299285|Secondary|Percentage of Dose of LY3009104 and LY3009104 Metabolites in Urine|Percentages of LY3009104 (parent) and LY3009104 metabolites that were excreted in the urine are reported. Only those metabolites that were detectable in the urine are included in the report.|Baseline up to 48 hours|Participants who took study drug.|||percentage of dose|||Number
1396201|NCT01299285|Secondary|Plasma Pharmacokinetics: LY3009104 and Radioactivity Time to Maximum Observed Concentration (Tmax)||Baseline up to 48 hours|Participants who took study drug.|||hour||Full Range|Median
1396202|NCT01299285|Secondary|Plasma Pharmacokinetics: Maximum Observed Radioactivity Concentration (Cmax)||Baseline up to 48 hours|Participants who took study drug.|||nanomole-equivalents/milliliter||Geometric Coefficient of Variation|Geometric Mean
1396203|NCT01299285|Secondary|Plasma Pharmacokinetics: Maximum Observed LY3009104 Concentration (Cmax)||Baseline up to 48 hours|Participants who took study drug.|||nanomoles/liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1396204|NCT01299285|Secondary|Plasma Pharmacokinetics: Radioactivity Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]||Baseline up to 48 hours|Participants who took study drug.|||hour*nanomole-equivalents/kilogram||Geometric Coefficient of Variation|Geometric Mean
1396205|NCT01299285|Secondary|Plasma Pharmacokinetics: LY3009104 Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)]||Baseline up to 48 hours|Participants who took study drug.|||hour*nanomoles/liter(h*nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1396206|NCT01299285|Primary|Percentage of the Total Radioactive Dose Administered Excreted From Urine and Feces||Baseline up to 120 hours|Participants who took study drug.|||percentage of total radioactivity||Standard Deviation|Mean
1396207|NCT01299272|Secondary|Change From Baseline in Pulse Rate up to Week 20 (Open-label Period)|Pulse measurements were collected when the participant was in a sitting position.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||beats per minute (bpm)||Standard Deviation|Mean
1396208|NCT01299272|Secondary|Change From Randomization in Pulse Rate at Week 44 (Double-blind Randomized Withdrawal Period)|Pulse rate measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline and baseline-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1396209|NCT01299272|Secondary|Change From Baseline in Blood Pressure up to Week 20 (Open-label Period)|Blood pressure measurements were taken 3 times at each visit in a sitting position. The average of the 3 values was used for analysis.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1396211|NCT01299272|Secondary|Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score at Week 20 (Open-label Period)|Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score is reported and ranges from 7 to 42, with higher scores indicating greater impairment.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396212|NCT01299272|Secondary|Change From Baseline in the Arizona Sexual Experiences (ASEX) Questionnaire up to Week 20 (Open-label Period)|Arizona Sexual Experiences (ASEX) Questionnaire is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each item is rated from 1 (extremely) to 6 (no/never). Possible total scores ranged from 5 to 30, with the higher scores indicating more sexual dysfunction.|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396213|NCT01299272|Secondary|Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Open-label Period)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Baseline through Week 20|All participants who have non-missing values at baseline and at least one post-baseline value.|||participants|||Number
1396214|NCT01299272|Secondary|Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) Index Scores, Visual Analog Scale up to Week 20 (Open-label Period)|The EQ-5D, a health-related, quality-of-life instrument, contains 2 parts: a health status profile and a visual analog scale (VAS). The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These dimensions are converted into weighted health-state index scores according to United States (US) and United Kingdom (UK) population-based algorithms. The US and UK based index scores range from -0.11 to 1.0 (where a score of 1.0 indicates perfect health) and from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), respectively. The VAS consists of participants rating their current health state from 0 (worst imaginable health state) to 100 (best imaginable health).|Baseline, up to Week 20|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396215|NCT01299272|Secondary|Change From Week 8 in the Sheehan Disability Scale (SDS) Items up to Week 20 (Stabilization Open-label Period)|The Sheehan Disability Scale (SDS) is completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396216|NCT01299272|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Items up to Week 8 (Acute Open-label Period)|The Sheehan Disability Scale (SDS) is completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396217|NCT01299272|Secondary|Change From Week 8 in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score up to Week 20 (Stabilization Open-label Period)|The Fatigue Associated with Depression (FAsD) is a 13-item participant-rated scale. Items 1-6 ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Items 7-13 ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score is derived by taking the mean of Items 1-6. The impact subscale score is derived by taking the mean of applicable Items 7-13. The average score is the mean of applicable Items 1-13. Item 12 applies only to participants with a spouse or significant other and Item 13 applies to participants who had a job or who went to school.|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396218|NCT01299272|Secondary|Change From Baseline in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score up to Week 8 (Acute Open-label Period)|The Fatigue Associated With Depression (FAsD) is a 13-item participant-rated scale. Items 1-6 ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Items 7-13 ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score is derived by taking the mean of Items 1-6. The impact subscale score is derived by taking the mean of applicable Items 7-13. The average score is the mean of applicable Items 1-13. Item 12 applies only to participants with a spouse or significant other and Item 13 applies to participants who had a job or who went to school.|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396219|NCT01299272|Secondary|Change From Week 8 in the Clinical Global Impression of Severity (CGI-S) Scores up to Week 20 (Stabilization Open-label Period)|The Clinical Global Impression of Severity (CGI-S) instrument is used to record the severity of mental illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396220|NCT01299272|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Scores up to Week 8 (Acute Open-label Period)|The Clinical Global Impression of Severity (CGI-S) instrument is used to record the severity of mental illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396221|NCT01299272|Secondary|Change From Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores up to Week 20 (Stabilization Open-label Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'.|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396222|NCT01299272|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores up to Week 8 (Acute Open-label Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'.|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396223|NCT01299272|Secondary|Change From Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores up to Week 20 (Stabilization Open-label Period)|Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8, up to Week 20|All participants who have non-missing values at Week 8 and at least one post-Week 8 value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396224|NCT01299272|Secondary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores up to Week 8 (Acute Open-label Period)|Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, up to Week 8|All participants who have non-missing values at baseline and at least one post-baseline value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Deviation|Mean
1396225|NCT01299272|Secondary|Change From Randomization in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score at Week 44 (Double-blind Randomized Withdrawal Period)|Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score is reported and ranges from 7 to 42, with higher scores indicating greater impairment. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline CPFQ total score and baseline CPFQ total score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1396226|NCT01299272|Secondary|Change From Randomization in the Arizona Sexual Experiences (ASEX) Questionnaire at Week 44 (Double-blind Randomized Withdrawal Period)|Arizona Sexual Experiences (ASEX) Questionnaire is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each item is rated from 1 (extremely) to 6 (no/never). Possible total scores ranged from 5 to 30, with the higher scores indicating more sexual dysfunction. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline ASEX total score and baseline ASEX total score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1396246|NCT01299077|Secondary|Onset Time of Symptom Relief.|Kaplan-Meier Estimates for the Average Onset Time of Symptom Relief. In this case the onset time of symptom relief was defined as the days between the end of triple therapy and the symptom improvement reported by patients.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Average Days of Onset Time||Standard Deviation|Mean
1396227|NCT01299272|Secondary|Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Double-blind Randomized Withdrawal Period)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions, which includes a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present during the period up through randomization. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Randomization through Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||participants|||Number
1396228|NCT01299272|Secondary|Change From Randomization in the EuroQol Questionnaire-5 Dimension (EQ-5D) Index Scores, Visual Analog Scale up to Week 44 (Double-blind Randomized Withdrawal Period)|The EQ-5D, a health-related, quality-of-life instrument, contains 2 parts: a health status profile and a visual analog scale (VAS). The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These dimensions are converted into weighted health-state index scores according to United States (US) and United Kingdom (UK) population-based algorithms. The US and UK based index scores range from -0.11 to 1.0 (where a score of 1.0 indicates perfect health) and from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), respectively. The VAS consists of participants rating their current health state from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) model with main effects of treatment, country, and baseline score.|Randomization, up to Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value. Last observation carried forward (LOCF) methodology was used.|||units on a scale||Standard Error|Least Squares Mean
1396229|NCT01299272|Secondary|Change From Randomization in the Sheehan Disability Scale (SDS) Items at Week 44 (Double-blind Randomized Withdrawal Period)|The Sheehan Disability Scale (SDS) is completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1396230|NCT01299272|Secondary|Change From Randomization in the Fatigue Associated With Depression (FAsD) Average Score, Experience Subscale Score, and Impact Subscale Score at Week 44 (Double-blind Randomized Withdrawal Period)|The FAsD is a 13-item participant-rated scale. Items 1-6 ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Items 7-13 ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score is derived by taking the mean of Items 1-6. The impact subscale score is derived by taking the mean of applicable Items 7-13. The average score is the mean of applicable Items 1-13. Item 12 applies only to participants with a spouse or significant other and Item 13 applies to participants who had a job or who went to school. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline score and baseline score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1396231|NCT01299272|Secondary|Change From Randomization in the Clinical Global Impression of Severity (CGI-S) Scores at Week 44 (Double-blind Randomized Withdrawal Period)|The Clinical Global Impression of Severity (CGI-S) instrument is used to record the severity of mental illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline CGI-S score and baseline CGI-S score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1396232|NCT01299272|Secondary|Change From Randomization in the Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores at Week 44 (Double-blind Randomized Withdrawal Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which included terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline subscale score and baseline subscale score-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1396247|NCT01299077|Primary|Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).|The measurement of overall satisfaction degree was in three scales, that was satisfactory, just so so and dissatisfactory. The measurement was estimated by both the physicians and the patients respectively.|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||percentage of participants|||Number
1396233|NCT01299272|Secondary|Change From Randomization in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Item Scores at Week 44 (Double-blind Randomized Withdrawal Period)|Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis which includes terms for the fixed categorical effects of treatment, country, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline MADRS total score (individual item score) and baseline MADRS total score (individual item score)-by-visit interaction.|Randomization, Week 44|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1396234|NCT01299272|Secondary|Percentage of Participants With Re-emergence of Depressive Symptoms (Double-blind Randomized Withdrawal Period)|Participants meeting any of the following criteria were determined as having major depressive disorder symptom re-emergence: 1) a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater ≥14 or a Clinical Global Impressions of Severity (CGI-S) increase of 2 or more points from Week 18 at 2 consecutive visits or 2) discontinuation due to lack of efficacy/worsening of depression/suicidality. The percentage of participants with re-emergence of depressive symptoms was calculated by dividing the number of participants who meet any of the criteria by the total number of participants analyzed, multiplied by 100. The MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity) to 60 (high severity). CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|Week 44|All randomized participants.|||percentage of participants|||Number
1396235|NCT01299272|Primary|Percentage of Participants Who Meet Criteria for Re-emergence of Depressive Symptoms Estimated by Kaplan-Meier Product Limit Method (Double-blind Randomized Withdrawal Period)|Participants meeting any of the following criteria were determined as having major depressive disorder symptom re-emergence: 1) a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater ≥14 or a Clinical Global Impressions of Severity (CGI-S) increase of 2 or more points from Week 18 at 2 consecutive visits or 2) discontinuation due to lack of efficacy/worsening of depression/suicidality. Time from randomization to the first visit at which the participant met the reemergence criteria was calculated. The percentage of participants who meet criteria was estimated using the Kaplan-Meier product limit method. The MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity) to 60 (high severity). CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|Randomization up to 44 weeks|All randomized participants.|||percentage of participants|||Number
1396236|NCT01299116|Secondary|Participant Attitudes to LARC vs SARC|Level of happiness with initial method (% distribution)|24 months||||Participants|||Count of Participants
1396237|NCT01299116|Secondary|Unintended Pregnancy|Intent-to-treat principles applied.|24 months||||Participants|||Count of Participants
1396238|NCT01299116|Primary|Contraceptive Method Discontinuation||24 months||||Participants|||Count of Participants
1396239|NCT01299103|Primary|Adverse Events|The rate of adverse events occurring in treatment subjects will be assessed.|90 days post treatment||||number of adverse events reported|||Number
1396240|NCT01299103|Primary|Fitzpatrick Wrinkle Assessment|Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease|change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment.||||units on a scale, change in Fitzpatrick||Standard Deviation|Mean
1396241|NCT01299090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The rate of adverse events will be assessed throughout the duration of the study|90 days post treatment||||participants|||Number
1396242|NCT01299090|Primary|Change in Neck and Facial Wrinkles Using the Fitzpatrick Wrinkle Assessment|"Three independent investigators blinded to photography time points will perform retrospective evaluations of photography from all visits using the 9-point Fitzpatrick Wrinkle Assessment Scale for assessment of neck and facial wrinkles at the culmination of the study.~The measurement is for percentage of patients who showed improvement"|90 days post treatment||||percentage of participants|||Number
1396243|NCT01299077|Secondary|Visual Analogue Scale (VAS) Score|Each patient is Scored on VAS at baseline and two weeks. VAS is the abbreviation of visual analogue score. There is no subscale in VAS. The maximum value of vas is 10 and the minimum is 0. This is self-evaluation method to present the severity of patient pain. More score number, more pain.|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Scores on VAS||Standard Deviation|Mean
1396244|NCT01299077|Secondary|Japanese Orthopedic Association (JOA) Score|"Each patient is Scored on JOA at baseline and two weeks. JOA is short for Japanese Orthopedic Association, which consists of 12 items: low back pain, lower extremity pain and numbness, walking ability, straight leg raising, muscle strength, sensory and etc. The first 3 item’s scores are range from 0 to 3 and the others are from 0 to 2. Higher score means better condition.~All of these items scores are combined for a total overall JOA score, which is range from 0 to 27."|Baseline and 2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Scores on JOA||Standard Deviation|Mean
1396245|NCT01299077|Secondary|Safety Data During Triple Therapy.|Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)|2 weeks|The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol.|||Percentage of participants|||Number
1396248|NCT01299025|Secondary|Change in the 12 Item Walking Scale From Day 1 to Day 42|The 12 item walking scale is a self-rating scale of walking limitations. The scale includes 12 items that each are scores from 1 to 5, where 5 is extremely limited. Scores are added and transformed to a scale from 0-100. 0 indicates no limitation and 100 extremely limited.|Measured at day 1 and day 42, before and after the training||||Scores on a scale||Standard Deviation|Mean
1396249|NCT01299025|Secondary|Change in the Activities-specific Balance Confidence (ABC) Scalefrom Day 1 to Day 42|The ABC scale is a self-rating scale of balance activities in everyday Life. It includes 16 items. The patient rates his/her performance from 0-100. Score on each item are summed an divided by 16. Minimum score is 0 and maximum score 100. A higher score indicate higher confidence in ones balance and walking capacity.|Measured at day 1 (before training) and day 42 (after training)||||Scores on a scale||Standard Deviation|Mean
1396250|NCT01299025|Secondary|Change in Score on the Dynamic Gait Index From Day 1 to Day 42|The Dynamic Gait index consists of 8 items. Performance on each item is rated from 0 (severe impairment) to 3 (nomal performance). Minimum total score is 0 and maximum 24. Higher scores indicate better walking and balance performance.|Measured at day 1 (before training) and day 42 (after training)||||Scores on a scale||Standard Deviation|Mean
1396251|NCT01299025|Primary|Change in Timed Up and Go Test From Day 1 to Day 42|Change in seconds on the Timed Up and Go test (TUG). In the TUG test time is taken from rising from a chair, walking 3 meters, turning,walking back and sitting down.|Measured at day 1 (before the training period) and at day 42 (after the training period)||||seconds||Standard Deviation|Mean
1396252|NCT01298778|Other Pre-specified|Emetic Symptoms|side effect potential with the increased dose of duramorph-percentage experiencing such symptoms|24hours|percentage of patients reporting emetic symptoms requiring treatment|||Participants|||Count of Participants
1396253|NCT01298778|Other Pre-specified|Pruritus|side effects-percentage of subjects requiring treatment|24 hours|percentage of patients with pruritis requiring treatment.|||Participants|||Count of Participants
1396254|NCT01298778|Secondary|Average Pain Over 24 Hours||24 hours|VAS pain score of 0=no pain at all up to 100 being worst pain imaginable.|||units on a scale||Standard Deviation|Mean
1396255|NCT01298778|Secondary|Incidence of Depression|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery.|2 months||||Participants|||Count of Participants
1396256|NCT01298778|Secondary|Analgesic Consumption|total amount of analgesic consumption|24 hour||||mg||Inter-Quartile Range|Median
1396257|NCT01298778|Secondary|Pain|resting pain, worst pain|24 hour||||units on a scale, 0 -none, 100-worst||Inter-Quartile Range|Median
1396258|NCT01298778|Secondary|Incidence of Persistent Pain|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery.|2 months||||percentage of participants|||Number
1396259|NCT01298778|Primary|Severity of Acute Pain|to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable.|24 hour||||mm||Standard Deviation|Mean
1396260|NCT01298765|Secondary|Investigator's Overall Satisfaction With Study Drug|Investigator's Overall Satisfaction with Study Drug measured on a 5-point scale, with 1 being not satisfied and 5 being very satisfied.|Baseline to Week 52||||units on a scale||Standard Deviation|Mean
1396261|NCT01298765|Secondary|Subjects Overall Satisfaction With Study Drug|Subjects Overall Satisfaction with Study Drug as measured on a 5 point scale, with 1 being not satisfied and 5 being very satisified.|Baseline to Week 52||||units on a scale||Standard Deviation|Mean
1396262|NCT01298765|Secondary|Treatment Satisfaction Questionnaire for Medication/Global Satisfaction|Treatment Satisfaction Questionnaire for Medication/Global Satisfaction at Week 28. Patients complete a 14 item questionaire that measures 4 scales based on side effects, effectiveness, convenience and global satisfaction. All items have either five or seven responses (except item 4), scored from one (least satisfied) to five or seven (most satisfied). The 7-item scales have a non-neutral midpoint, such that there are more positive response options than negative response options. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0–100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items|Baseline to Week 28||||units on a scale||Standard Deviation|Mean
1396263|NCT01298765|Secondary|Patient Global Impression of Change in Pain Intensity|Patient Global Impression of Change in Pain Intensity at Week 28 as measured by a 7 point scale. Patients measure their improvement from 7='very much improved', 6='much improved', 5='minimally improved', 4='no change', 3='minimally worse', 2='much worse', 1='very much worse'.|Baseline to Week 28||||units on a scale||Standard Deviation|Mean
1396264|NCT01298765|Primary|Change From Baseline in NRS Pain Intensity|The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.|Baseline up to approximately Week 52||||units on a scale||Standard Deviation|Mean
1396265|NCT01298661|Secondary|"Third Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||bpm||Standard Deviation|Mean
1396266|NCT01298661|Secondary|"Second Six Minute Step Test Heart Rate"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
1396268|NCT01298661|Secondary|"Third Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||bpm||Standard Deviation|Mean
1396269|NCT01298661|Secondary|"Second Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor at rest and every two minutes of the test."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
1396270|NCT01298661|Secondary|"First Six Minute Walk Test Heart Rate"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a cardio monitor."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||bpm||Standard Deviation|Mean
1396271|NCT01298661|Secondary|"Third Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||% of hemoglobin||Standard Deviation|Mean
1396272|NCT01298661|Secondary|"Second Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter ."|First day or second day of the protocol (random) ,30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
1396273|NCT01298661|Secondary|"First Six Minute Step Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
1396274|NCT01298661|Secondary|"Third Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||% of hemoglobin||Standard Deviation|Mean
1396275|NCT01298661|Secondary|"Second Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|,First day or second day of the protocol (random) 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
1396276|NCT01298661|Secondary|"First Six Minute Walk Test Peripheral Oxygen Saturation"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. It will be evaluated by a pulse oxymeter."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||% of hemoglobin||Standard Deviation|Mean
1396277|NCT01298661|Secondary|"Third Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 2, the patient will step up down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||units on a scale||Full Range|Median
1396278|NCT01298661|Secondary|"Second Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute.The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MST|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
1396389|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with HIP BMD measurements both at AI commencement and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
1396279|NCT01298661|Secondary|"First Six Minute Step Test Exertion Perception"|"This test will be conducted by the Rater 1, the patient will step up and down one 20cm step during six minute. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
1396280|NCT01298661|Secondary|"Third Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||units on a scale||Full Range|Median
1396281|NCT01298661|Secondary|"Second Six Minute Walk Test Exertion Perception"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random), 30 minutes after the first 6MWT|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
1396282|NCT01298661|Secondary|"First Six Minute Walk Test Exertion Perception"|"This test was conducted by the Rater 1, the subject walked as far as it could in a 30m corridor during 6 minutes. The Exertion Perception will be evaluated using BORG scale. This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt). Lower values means that the patient feel less discomfort."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||units on a scale||Full Range|Median
1396283|NCT01298661|Secondary|"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity Index (BODE Index)"|"It was evaluated only in the COPD patients. BODE index is a prognostic index used in COPD patients, it is a 0-10 scale, where lower values means better prognostic. It is composed by other commonly used evaluations tools in COPD, Forced Expiratory Volume in the First second (from spirometry); classification in the scale ranging from 0-3, Body-mass index, classification in the scale ranging from 0-1; Six-minute walk test distance, classification in the scale ranging from 0-3 and referred dyspnea, classification in the scale ranging from 0-3.~It was only used the total score (0-10)"|Second day|2 COPD were excluded since they did not appeared in the second day of evaluation. The other two populations were not verified, since the measure is specific for COPD patients|||units on a scale||Inter-Quartile Range|Median
1396284|NCT01298661|Secondary|"Third Six Minute Walk Test Distance"|"This test will be conducted by the Rater 2, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||meter||Standard Deviation|Mean
1396285|NCT01298661|Secondary|"Second Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|On the first or second day of evaluation (random), 30 minutes after the first 6MWT.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||meter||Standard Deviation|Mean
1396286|NCT01298661|Secondary|"First Six Minute Walk Test Distance"|"This test will be conducted by the Rater 1, the subject will walk as far as it can in a 30m corridor during 6 minutes. The performance will be the distance (meters)that it walk."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||meter||Standard Deviation|Mean
1396287|NCT01298661|Primary|"Third Six Minute Step Test Performance"|"This test will be conducted by the Rater 2, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.|2 COPD patients and 2 healthy young individuals were excluded from the study since they did not appeared in the second day of evaluation. 3 COPD patient Analysis Population Description: s and 5 elderly subjects didn't show on the third day of evaluation, then, they were just excluded in the analysis of the variables collected in this day.|||steps||Standard Deviation|Mean
1396288|NCT01298661|Primary|"Second Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minutes. The performance will be evaluated by the number of the climbs."|On the first or second day of evaluation (random), 30 minutes after the first 6MST.|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||steps||Standard Deviation|Mean
1396480|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1000h (1 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
1396289|NCT01298661|Primary|"First Six Minute Step Test Performance"|"This test will be conducted by the Rater 1, the patient will step up and down a 20cm step during six minute. The performance will be evaluated by the number of the steps."|First day or second day of the protocol (random)|2 COPD patients and 2 healthy young individuals were excluded since they did not appeared in the second day of evaluation.|||steps||Standard Deviation|Mean
1396290|NCT01298648|Secondary|Remission Rate at Week 4, Week 8, and Week 24|The remission rate for each evaluation timepoint (Weeks 4, 8, and 24) was calculated as the number of participants that had CDAI < 150 divided by the number of participants at Baseline that had CDAI scores ≥ 150.|Baseline, Week 4, Week 8, and Week 24|Participants with available data at each time point.|||percentage of participants|||Number
1396291|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 24|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 24|Participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
1396292|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 8|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 8|Participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
1396293|NCT01298648|Secondary|Improvement Rating by Investigator at Week 24|Overall response rating, according to investigator’s subjective clinical opinion. The level of improvement (markedly improved, improved, not improved, or not assessable) was categorized by comparing clinical condition at week 24 or at discontinuation with baseline condition.|Week 24||||percentage of participants|||Number
1396294|NCT01298648|Primary|Crohn's Disease Activity Index (CDAI) at Baseline and Week 4|The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease.|Baseline, Week 4|Participants with available data at each time point.|||scores on a scale||Standard Deviation|Mean
1396295|NCT01298648|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|24 weeks|Safety analysis set: Excluding 21 patients who were transferred to other institutions during the surveillance period and 2 patients who made no visit after the first administration, 1693 patients were included in the safety analysis set.|||participants|||Number
1396296|NCT01298570|Secondary|Percentage of Patients With Severe Adverse Events|Toxicity Assessments were made according to NCI CTCAE v. 4.0 . Severe events (grades 3-4) that occurred in a higher percentage of regorafenib treated participants as compared to placebo are reported below.|3 years|All patients who received treatment|||percentage of participants|||Number
1396297|NCT01298570|Secondary|Drug Metabolism|To compare the pharmacokinetic (PK) profile of FOLFIRI between a subset of patients receiving regorafenib (ARM A) and patients receiving placebo (Arm B). The Area Under the Curve (AUC) levels of the irinotecan metabolite SN-38 were compared.|28 days|This objective was designed to only look at a small subset of participants (11 on each arm)|||AUC/dose=(ng/mL*h)/(mg/m^2)||Inter-Quartile Range|Median
1396298|NCT01298570|Secondary|Overall Survival (OS)|To compare overall survival (OS) between ARM A and ARM B. OS is defined as the time from randomization until death as a result of any cause.|7 years||||Months||Full Range|Median
1396299|NCT01298570|Secondary|Disease Control (DC) Rate|To compare Disease Control (DC) Rate (DC= CR + PR + SD) between ARM A and ARM B as defined via Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and Stable Disease (SD) ), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years|Only evaluable participants (those who had RECIST measurements after baseline) were included in this analysis|||Participants|||Count of Participants
1396300|NCT01298570|Secondary|Overall Response(OR)Rate|To compare overall response (OR) rates (OR= CR + PR) between ARM A and ARM B as defined via Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|3 years|Only evaluable participants (those who had RECIST measurements after baseline) were included in this analysis|||Participants|||Count of Participants
1396301|NCT01298570|Primary|Progression Free Survival (PFS)|To compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients failing one prior oxaliplatin-containing regimen for metastatic colorectal cancer. PFS is defined as the time from randomization until metastatic colorectal cancer (mCRC) progression or death as a result of any cause. Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|7 years||||Months||95% Confidence Interval|Median
1396302|NCT01298544|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL, 36 Months After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population|||Percentage of participants||95% Confidence Interval|Number
1396303|NCT01298544|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|Day 1 (36 months after toddler dose)|Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1396304|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Weeks 12 and 16|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||cm||Standard Deviation|Mean
1396305|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 8|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||cm||Standard Error|Least Squares Mean
1396306|NCT01298531|Other Pre-specified|Change From Baseline in Chest Expansion at Week 4|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation and the data presented below combined both the values.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||cm||Standard Error|Least Squares Mean
1396307|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 16|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396308|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 12|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396326|NCT01298531|Other Pre-specified|Change From Baseline in PGA at Weeks 12 and 16|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396309|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396310|NCT01298531|Other Pre-specified|Change From Baseline in BASMI Components at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score was composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. For each BASMI component, the best of the two tries was taken which corresponded to the highest value for cervical rotation, intermalleolar distance, modified Schober’s test and lateral flexion and the smallest value for tragus to wall distance. For cervical rotation, lateral flexion and tragus to wall distance, a mean of the left and right measurements was taken.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396311|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Weeks 12 and 16|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396312|NCT01298531|Other Pre-specified|Change From Baseline in BASMI at Week 8|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396313|NCT01298531|Other Pre-specified|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396314|NCT01298531|Other Pre-specified|Number of Participants With PASS at Weeks 4, 12 and 16|PASS is defined as a symptom state that the participants consider acceptable. The PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396315|NCT01298531|Other Pre-specified|Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8|PASS is defined as a symptom state that the participants consider acceptable. PASS was collected weekly in the diary card, but at each visit this was collected in the CRF. Participants assessed their health in the previous 48 hours and whether it would be acceptable to remain like that in the next few months.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396316|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16|MCID was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCID was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain. MCID was evaluated based on participant's opinion on the following three items for the question of how have they been during the last 48 hours compared to Screening visit: 'improved-less pain', 'no change', and 'worse-more pain'. Participants were further asked the importance of worsening i.e., very important, moderately important, slightly important and not at all important as MCID evaluation criteria.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396373|NCT01298518|Secondary|Change From Baseline in Fasting Insulin at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting insulin value. Here, 'n' is participants evaluable at specified time points for each group.|||micro-IU/mL||Standard Deviation|Mean
1396317|NCT01298531|Other Pre-specified|Number of Participants With MCII at Weeks 4, 12 and 16|MCII was completed at Weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396318|NCT01298531|Other Pre-specified|Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8|MCII was completed at visit weeks 4, 8, 12 and 16 or Early Discontinuation and once weekly between visits. MCII was converted to binary scores as follows: 1 = ‘improved’/’very important’ and ‘improved’/’moderately important’ 2 = ‘improved’/’slightly important’, ‘improved’/’not at all important’, ‘no change’ and ‘worse-no pain'. MCII was determined based on participant's response on the following three items for the question of how have they been during the last 48 hours compared to when they started the study: improved or less pain, no change and worse-more pain. MCII was typically defined according to the patients perception of what was very important improvement, moderate important improvement, slightly important improvement or not at all improvement.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396319|NCT01298531|Other Pre-specified|Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396320|NCT01298531|Other Pre-specified|Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16|Tender joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Tender joints||Standard Deviation|Mean
1396321|NCT01298531|Other Pre-specified|Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16|Swollen joint count was performed at each visit to assess the peripheral joint involvement according to ASAS recommendation.|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Swollen joints||Standard Deviation|Mean
1396322|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 16|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396323|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 12|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 12|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396324|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 8|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396325|NCT01298531|Other Pre-specified|Change From Baseline in Each BASFI Component at Week 4|BASFI is to assess the prticipant's level of ability to complete the activities on a scale from 0 (easy) to 10 (impossible). The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396584|NCT01295814|Secondary|Interstitial Cystitis Problem Index (ICPI)|Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)|Baseline/12 Weeks||||units on a scale||Standard Deviation|Mean
1396327|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 8|Investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396328|NCT01298531|Other Pre-specified|Change From Baseline in PGA (Physician Global Assessment) at Week 4|The investigator assessed the overall disease activity using the scale of 0 (no disease activity) to 10 (severe disease activity).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396329|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396330|NCT01298531|Secondary|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396331|NCT01298531|Other Pre-specified|Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4|Participants were requested to complete the BASDAI upon symptom return then every day for the first 15 days after first administration of test article and weekly thereafter. A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or swelling, discomfort and morning stiffness severity respectively) it was on the scale from 0 (none) to 10 (very severe). For question 6 (morning stiffness duration) it was on the scale of 0 (0 or more hours) to 10 (2 hours). The analysis presented below is the change in morning stiffness severity.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396332|NCT01298531|Other Pre-specified|Change From Baseline in BASFI at Week 8|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396333|NCT01298531|Other Pre-specified|Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4|Participants assessed their level of ability to complete activities on a scale from 0 (easy) to 10 (impossible). These scales were collected at each visit in the CRF. The total score was calculated as the average score of the 10 questions.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396334|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396335|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 8|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396336|NCT01298531|Other Pre-specified|Change From Baseline in Nocturnal Back Pain at Week 4|Participants assessed the nocturnal back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396337|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Weeks 4, 8, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396338|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 8|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396339|NCT01298531|Other Pre-specified|Change From Baseline in Total Back Pain at Week 4|Participants assessed the total back pain they had in the previous 48 hours on a scale from 0 (no pain) to 10 (most severe pain).|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396340|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Weeks 12 and 16.|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396341|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G Score at Week 8|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396342|NCT01298531|Other Pre-specified|Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4|BAS-G was used to indicate the effect of disease has had on participant's well-being over the last 48 hours in a 0 (none) to 10 (very severe) point scale. Participants completed the BAS-G on a diary card following their Screening visit if they had a flare which required them to restart their NSAID. Participants were requested to complete the BAS-G upon symptom return (after stoppage of NSAIDs during screening phase) and weekly thereafter.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396343|NCT01298531|Secondary|Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.|||Scores on a scale||Standard Error|Least Squares Mean
1396344|NCT01298531|Secondary|Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases with no imputation.|||Scores on a scale||Standard Error|Least Squares Mean
1399644|NCT01265550|Secondary|Number of Successful Participants With Irritable Bowel Syndrome|Presence of irritable bowel syndrome as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes|||Participants|||Count of Participants
1396345|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396346|NCT01298531|Secondary|Change From Baseline in ASDAS ESR Score at Week 8.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396347|NCT01298531|Secondary|Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.|"The ASDAS-ESR was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease (< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS ESR is calculated as follows:~ASDAS ESR=0.08*Total Back Pain+0.07*Duration of Morning Stiffness+0.11*Patient Global+0.09*Peripheral Pain/Swelling+0.29*√(ESR)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396348|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Weeks 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Units on scale||Standard Deviation|Mean
1396349|NCT01298531|Secondary|Change From Baseline in ASDAS CRP Score at Week 8.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396350|NCT01298531|Secondary|Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.|"The ASDAS-CRP was derived from back pain, duration of morning stiffness, patient global score and peripheral pain/swelling. The scores were categorized as follows : inactive disease(< 1.3), moderate (1.3 – < 2.1), high (2.1 – 3.5) and very high disease activity ( > 3.5). ASDAS CRP is calculated as follows:~ASDAS CRP=0.12*Total Back Pain+0.06*Duration of Morning Stiffness+0.11*Patient Global+0.07*Peripheral Pain/Swelling+0.58*ln(CRP+1)."|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396351|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity)|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
1396352|NCT01298531|Secondary|Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396374|NCT01298518|Secondary|Change From Baseline in Fasting Glucose at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting glucose value. Here, 'n' is participants evaluable at specified time points for each group.|||mg/dL||Standard Deviation|Mean
1399645|NCT01265550|Secondary|Number of Successful Participants With Cyclic Vomiting Syndrome|Presence of cyclic vomiting syndrome as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1396353|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
1396354|NCT01298531|Secondary|Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396355|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 at Week 8|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
1396356|NCT01298531|Secondary|Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396357|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.|Response was defined as a 50% improvement of the baseline BASDAI after 4, 12 and 16 Weeks.|Weeks 4, 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was performed with the observed cases.|||Participants|||Number
1396358|NCT01298531|Secondary|Number of Participants Achieved BASDAI 50 at Week 8.|Response was defined as a 50% improvement of the baseline BASDAI after 8 Weeks.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Participants|||Number
1396359|NCT01298531|Secondary|Change From Baseline in Mini BASDAI at Week 8 (AUC).|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. The efficacy analysis was based on the ITT population. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis.|||Unit on a scale * days||Standard Error|Least Squares Mean
1396360|NCT01298531|Secondary|Number of Participants Using NSAIDs at Week 8.|Participants who received NSAIDs at Week 8 were reported.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.|||Participants|||Number
1396361|NCT01298531|Secondary|Change From Baseline in BASDAI Score at Weeks 12 and 16.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 12 and 16|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. This analysis was with the observed cases.|||Units on a scale||Standard Deviation|Mean
1396375|NCT01298518|Secondary|Change From Baseline in Peptide YY (PYY) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in PYY area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PYY area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||pg*hr/mL||Standard Deviation|Mean
1396362|NCT01298531|Secondary|Change From Baseline in BASDAI at Week 8|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major AS symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396363|NCT01298531|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.|A numeric rating scale was used, for questions 1-5 (Fatigue, Spinal Pain, Joint pain or Swelling, Discomfort and Morning stiffness severity respectively) on a scale from 0 (none) to 10 (very severe). Question 6 (morning stiffness duration) was recorded on a scale of 0 (0 or more hours) to 10 (2 hours). To give the five major Ankylosing Spondylitis (AS) symptoms equal weighting, the average of the two scores relating to morning stiffness was taken. This averaged morning stiffness score was then summed with the remaining 4 questions, resulting in a composite score on a scale of 0-50, which was then divided by 5 to give the final BASDAI score on a scale of 0-10.|Week 4|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Least Squares Mean
1396364|NCT01298531|Secondary|Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.|The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule. LOCF will only be applied where the subject is still in the study and the NSAID score is missing.|Week 8|The ITT population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through LOCF approach.|||Unit on a scale * days||Standard Error|Least Squares Mean
1396365|NCT01298531|Primary|Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.|"Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken.~Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption."|Week 8|The Intent To Treat (ITT) population comprised all participants who received at least one dose of the randomized treatment. Participants were analyzed according to treatment randomized and any data recorded after entry into the escape arm were included in the analysis. Missing data were imputed through last observation carried forward (LOCF).|||Scores on a scale||Standard Error|Least Squares Mean
1396366|NCT01298518|Secondary|Area Under the Concentration-Time Curve AUC (0-24) of PF-04620110|"Area under the plasma concentration-time curve from time 0 (pre-dose) to 24 hours.~AUC (0-24) was computed using the linear trapezoidal method."|24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 AUC(0-24) value.|||ng*hr/mL||Standard Deviation|Geometric Mean
1396367|NCT01298518|Secondary|Time to Cmax (Tmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Tmax value.|||hr||Full Range|Median
1396368|NCT01298518|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmin value.|||ng/mL||Standard Deviation|Geometric Mean
1396369|NCT01298518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04620110||24 hours post-morning dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 Cmax value.|||ng/mL||Standard Deviation|Geometric Mean
1396370|NCT01298518|Secondary|Change From Baseline in Post-Dinner Glucose Excursions Area Under the Concentration-Time Curve From Time 12 to 16 Hours (AUC 12-16) Post-dose at Day 28|Change from baseline in post-dinner glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 12 to 16 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-dinner glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
1396371|NCT01298518|Secondary|Change From Baseline in Post-Lunch Glucose Excursions Area Under the Concentration-Time Curve From Time 6 to 10 Hours (AUC 6-10) Post-dose at Day 28|Change from baseline in post-lunch glucose excursion under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 6 to 10 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-lunch glucose excursion area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
1396372|NCT01298518|Secondary|Change From Baseline in Fasting Net Triglycerides at Day 28||0 hour (pre-dose) on Day -1, Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 fasting net triglycerides value. Here, 'n' is participants evaluable at specified time points for each group.|||mg/dL||Standard Deviation|Mean
1396376|NCT01298518|Secondary|Change From Baseline in Gastric Inhibitory Peptide (GIP) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in GIP area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 GIP area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||pg*hr/mL||Standard Deviation|Mean
1396377|NCT01298518|Secondary|Change From Baseline in Total Amide Glucagon Like Peptide-1 (GLP-1) and Active Glucagon Like Peptide-1 (GLP-1) Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) at Day 28|Change from baseline in total amide GLP-1 and active GLP-1 area under the plasma concentration time curve was computed by Linear trapezoidal method.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 total amide GLP-1 and active GLP-1 area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||pmol*hr/L||Standard Deviation|Mean
1396378|NCT01298518|Secondary|Change From Baseline in Post-Prandial Net Triglyceride Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma net triglyceride concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT net triglyceride area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
1396379|NCT01298518|Secondary|Change From Baseline in Post-Prandial C-Peptide Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT C-peptide area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||ng*hr/mL||Standard Deviation|Mean
1396380|NCT01298518|Secondary|Change From Baseline in Post-Prandial Insulin Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT insulin area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||micro-IU*hr/mL||Standard Deviation|Mean
1396381|NCT01298518|Secondary|Change From Baseline in 24-Hour Average Plasma Glucose (APG) Post-Dose at Day 28|APG= AUC (0-24)/24. AUC (0-24) was computed using Linear trapezoidal method.|Baseline (Day -1); 24 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 APG value. Here, 'n' is participants evaluable at specified time points for each group.|||mg/dL||Standard Deviation|Mean
1396382|NCT01298518|Primary|Change From Baseline in Post-Prandial Glucose Area Under the Concentration-Time Curve From Time 2 to 6 Hours (AUC 2-6) After a Mixed Meal Tolerance Test (MMTT) at Day 28|Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.|Baseline (Day -1); 2 to 6 hours post-dose on Day 28|Analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 post-MMTT glucose area under the curve (AUC) value. Here, 'n' is participants evaluable at specified time points for each group.|||mg*hr/dL||Standard Deviation|Mean
1396383|NCT01298492|Secondary|Serum Trough Concentrations of PF-00547659 Versus Time|Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.|Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96|PK population included all enrolled participants who received at least 1 dose of investigational product and had data on at least 1 PK concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1396384|NCT01298492|Secondary|Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies|Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points.|Baseline up to Week 96|The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
1396385|NCT01298492|Primary|Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)|AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.|From start of study treatment up to Week 72 (Treatment Period)|The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
1396386|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From AI Commencement to Month 12 of Therapy.||Month 1-6 (depending on duration of chemotherapy) and month 13-18|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
1396387|NCT01298362|Secondary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Chemotherapy Completion||Baseline and month 1-6 (depending on duration of chemotherapy)|Patients with LS BMD measurements both at baseline (before chemotherapy commencement) and at chemotherapy completion|||percentage of change||95% Confidence Interval|Mean
1396388|NCT01298362|Secondary|Bone Fracture Rate||During the 12 months of AI Therapy|All patients with available 12 month follow-up during AI treatment|||participants|||Number
1396390|NCT01298362|Secondary|Percentage Change in Lumbar Spine Bone Mineral Density Before AI Commencement to Month 12 of Therapy for Patients Who Are Treated With AIs as First Line Therapy||From AI commencement to month 12 of AI therapy|Patients with LS BMD measurements both at AI commencement and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
1396391|NCT01298362|Secondary|Percentage Change in Total Hip Bone Mineral Density From Baseline to Month 12 of AI Therapy.||Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with HIP BMD measurements both at baseline and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
1396392|NCT01298362|Primary|Mean Percentage Change in Lumbar Spine Bone Mineral Density From Baseline (Before Chemotherapy Commencement) to Month 12 of AI Therapy|"BMD was evaluated at lumbar spine (LS) and hip (HIP) with measurements taken before CT, before AI therapy and at the end of the 12 month followup period while on AI treatment. Dual Energy X-Ray Absorptiometry (DEXA scan) was used with all measurements performed with the Explorer absorptiometer produced by Hologic, Bedford, MA, USA in the same referral site in Athens, apart from two centres in other cities which used however the same absorptiometer model with identical software.~The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group."|Baseline and month 13-18 (1-6 months of chemotherapy + 12 months of AI therapy)|Patients with LS BMd measurements both at baseline and at 12 months of AI therapy.|||percentage of change||95% Confidence Interval|Mean
1396393|NCT01298323|Primary|Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.|The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.|12 months|Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.|||Percentage of days|months|Standard Deviation|Mean
1396394|NCT01298167|Primary|Visual Analog Scale (VAS)|"The Visual Analog or Analogue Scale (VAS)* is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to their feeling. It also gives the maximum opportunity for each respondent to express a personal response style.~The scale is interpreted as the greater the scale score (as the score approaches 10), the greater the cosmetic and functional outcome of the healed wound.~Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993~Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102~Hayes, M. H. S. & D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99"|3 months|Individuals' wounds were divided in half and then treated with both Cyanoacrylate and Fast Absorbing Gut Suture. Individuals were randomized as to which half of the wound (superior or inferior) would be treated by each of the methods.|||units on a scale||Standard Deviation|Mean
1396395|NCT01298128|Primary|Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)|abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain|patients were followed for the duration of an in-vitro fertilization cycle- 2 months|70 patients were recruited and randomized. 53 patients completed the study. 11 patients did not then undergo an ivf cycle after recruitment. 6 patients withdrew from the study after recruitment.|||participants|||Number
1396396|NCT01298063|Secondary|Clinical Relevant Abnormalitites for Physical Examination, Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Adverse Event, Investigator's Global Tolerability|Clinical relevant abnormalitites for physical examination, vital signs, 12-lead electrocardiogramm (ECG), clinical laboratory test (including hematology, clinical chemistry, coagulation, urinalysis), adverse event, investigator's global tolerability. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 28 days after last administration of trial medication|Treated set|||participants|||Number
1396397|NCT01298063|Secondary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1396398|NCT01298063|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of the analyte in plasma|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|PK analysis set. Group B1 was not included in the primary analysis set for comparison.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1396399|NCT01298063|Primary|Area Under Curve From 0 to Infinity (AUC0-infinity)|AUC0-infinity represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|30 minutes (min) prior to first dosing and 30 min, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 9 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h, 144 h, 168 h, 240 h after first dosing|Pharmacokinetic (PK) analysis set includes all evaluable matched subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations. Group B1 was not included in the primary analysis set for comparison.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1396400|NCT01297920|Primary|Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3|The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-Treat (ITT): All subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.|||millimeters mercury (mm HG)||Standard Error|Least Squares Mean
1396401|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Infinite Time [MRAUC (0- ∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0- ∞) [MRAUC (0- ∞)].|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.|||Ratio||Standard Deviation|Geometric Mean
1396402|NCT01297595|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1396403|NCT01297595|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite (PF-06260182) to parent (crizotinib) molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1396404|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1396405|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1396406|NCT01297595|Secondary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. ‘N’ = Number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1396407|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1396408|NCT01297595|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Liter||Standard Deviation|Geometric Mean
1396409|NCT01297595|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the plasma. Clearance obtained after oral dose (apparent oral clearance [CL/F]) is influenced by the fraction of the dose absorbed (F).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Liter/hour (L/hr)||Standard Deviation|Geometric Mean
1396410|NCT01297595|Secondary|Plasma Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1396411|NCT01297595|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1396412|NCT01297595|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1396413|NCT01297595|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1396437|NCT01297465|Secondary|Number of Fetal Hearts With Activity|Number of fetal hearts with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||fetal hearts||Standard Deviation|Mean
1396414|NCT01297595|Primary|Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1396415|NCT01297517|Primary|Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)|At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Month 3|Intent-to-treat (ITT): All patients who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment.|||millimeters mercury (mm Hg)||Standard Error|Least Squares Mean
1396416|NCT01297504|Secondary|Mean Number of Doses of Palivizumab Administered||12 months||||doses||Standard Deviation|Mean
1396417|NCT01297504|Primary|Distribution of Comorbidities in Study Participants|The percentage of participants with each and combinations of the three comorbidities for which palivizumab is indicated.|Baseline||||percentage of participants|||Number
1396418|NCT01297504|Secondary|Compliance to Prescribed Palivizumab|Compliance to prescribed palivizumab was calculated based on the number of doses received versus the expected number of doses for each participant. The expected number of doses for each participant was estimated based on seasonality and current prescription guidelines for each country.|12 months||||Percentage of expected dose||95% Confidence Interval|Number
1396419|NCT01297504|Secondary|Risk Factors for Hospitalization|Variables that could act as risk factors for hospitalization for lower respiratory tract infection were tested in univariate and multivariate Poisson regression models. Baseline characteristics, such as age, gender, birth weight and comorbidities were included as covariates in the Poisson regression model. Variables for multivariate analysis were added applying forward selection. Gestational age and birth weight were included as continuous variables, considering that the higher they were the better they could act as a protection factor for hospitalization due to respiratory infection.|Baseline and 12 months||||rate ratio||95% Confidence Interval|Number
1396420|NCT01297504|Secondary|Characterization of Hospitalization Episodes Due to Lower Respiratory Tract Infection and RSV||12 months|Participants with hospitalization due to LTRI and hospitalization due to LTRI and RSV.|||hospitalization episodes|Participants||Number
1396421|NCT01297504|Secondary|Number of Participants With Hospitalizations for Lower Respiratory Tract Infection and RSV|The number of participants with hospitalizations due to lower respiratory tract infection (LRTI) and hospitalizations due to lower respiratory tract infection caused by RSV.|12 months||||participants|||Number
1396422|NCT01297504|Primary|Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection|Study participants were characterized at Baseline by history of bronchopulmonary dysplasia, history of prematurity (less than or equal to 35 weeks gestational age), children with hemodynamically significant congenital heart disease (CHD), the presence of cohabitants less than 6 years old, possible exposure to indoor tobacco smoke, day care attendance, asthmatic or atopic mother, smoking during pregnancy, breastfeeding, prenatal assistance (4 or more visits during pregnancy), neonatal hospitalization care, history of neonatal assisted ventilation, and mother education level (completed primary school).|Baseline||||participants|||Number
1396423|NCT01297491|Secondary|Duration of Response (DoR)|DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.|||Days|||Number
1396424|NCT01297491|Secondary|Time to Response (TTR)|TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.|||Days|||Number
1396425|NCT01297491|Secondary|Disease Control Rate (DCR)|"DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.~Analyses of response rates were performed based on investigators’ assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline."|Every 6 weeks up tp 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Percentage of participants|||Number
1396438|NCT01297465|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan|Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||fetal sacs||Standard Deviation|Mean
1396426|NCT01297491|Secondary|Overall Response Rate (ORR) Based on Investigator Assessment|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators’ assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.|Every 6 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Percentage of participants|||Number
1396427|NCT01297491|Secondary|Overall Survival (OS) Using Kaplan-Meier Estimates|OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.|Every 8 weeks up to 24 months|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1396428|NCT01297491|Primary|Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12|"PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a success for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate <50% at 12 weeks was observed.~No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group."|Week 12|Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1396429|NCT01297465|Secondary|Heart Rate Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||beats per minute (bpm)||Standard Deviation|Mean
1396430|NCT01297465|Secondary|Systolic and Diastolic Arterial Blood Pressure Assessments||Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®. .N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||millimeter of mercury ( mm Hg)||Standard Deviation|Mean
1396431|NCT01297465|Secondary|Number of Participants With Treatment-emergent Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||participants|||Number
1396432|NCT01297465|Secondary|Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Early OHSS was defined as the onset of OHSS occurring within 9 days after oocyte retrieval and late OHSS was defined as the onset of OHSS occurring on or after day 10 from oocyte retrieval.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||participants|||Number
1396433|NCT01297465|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."|||participants|||Number
1396434|NCT01297465|Secondary|Biochemical Pregnancies Rate|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of human chorionic gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Participants with beta- hCG concentration greater than 10 international units per liter (IU/L) were considered as biochemical pregnant.|Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment. . N (number of participants analyzed) signifies those participants who had their embryo transfer in study treatment cycle."|||participants|||Number
1396435|NCT01297465|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment|An excessive ovarian response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An insufficient ovarian response: defined as 3 or less follicles of greater than or equal to 12 millimeter developing following at least 7 days of treatment.|S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||participants|||Number
1396436|NCT01297465|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Clinical pregnancy rate was reported as total clinical pregnancy rate, clinical pregnancy rate per cycle started and per embryo transfer [ET]).|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|"Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and had completed the primary efficacy assessment. N signifies those participants who had their ET in study treatment cycle. n signifies those participants who were evaluated for this measure in specified categories."|||percentage of participants|||Number
1396439|NCT01297465|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100.|Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])|Mod-ITT population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.|||percent sacs per embryo||Standard Deviation|Mean
1396440|NCT01297465|Secondary|Total Number of Stimulation Treatment Days||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||days||Standard Deviation|Mean
1396441|NCT01297465|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])|Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.|||IU||Standard Deviation|Mean
1396442|NCT01297465|Primary|Total Number of Oocytes Retrieved|The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])|Modified intention-to-treat (Mod-ITT) population included all the randomized participants who had received at least one dose of GONAL-f® or Pergoveris®, and completed the primary efficacy assessment.|||oocytes||Standard Deviation|Mean
1396443|NCT01297348|Primary|Number of Idiopathic Venous Thromboembolism (VTE) Cases and Matched Controls|Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.|||participants|||Number
1396444|NCT01297348|Primary|Incidence Rate of Idiopathic Venous Thromboembolism (VTE)|Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control.|Index date (date of VTE diagnosis for case and corresponding date for matched control)|Analysis population included all enrolled participants who met the eligibility criteria.|||incidence rate per 100000 person-years|||Number
1396445|NCT01297335|Secondary|Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection|Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth.|Before clonidine injection (Baseline), and at 1 hour after clonidine injection.|All qualified subjects were given intrathecal clonidine and were asked to rate level of sedation and sensation of dry mouth before clonidine injection (baseline) and 1 hour post injection on VAS scale.|||cm||Standard Deviation|Mean
1396446|NCT01297335|Secondary|Likert Scale Pain Rating|Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain.|Pre-dose and 1 hour post injection.|All subjects met inclusion and exclusionary criteria, and received intrathecal injection of clonidine. Subjects were asked to rate their baseline pain on Likert scale prior to receiving intrathecal clonidine injection, and 1 hour post intrathecal clonidine injection.|||units on a scale||Standard Deviation|Mean
1396447|NCT01297335|Primary|Change in Blood Pressure After Intrathecal Injection of Clonidine.|"Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours.~Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline."|Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection|All subjects met inclusion and exclusionary criteria, and was given an intrathecal injection of clonidine. They were followed for changes in blood pressure for 4 hours.|||mm Hg||Standard Deviation|Mean
1396448|NCT01297322|Secondary|Rate of Combined Minor Access Site Complications|"Secondary safety endpoint~Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis;~Access site-related hematoma > 6 cm;~Late access site-related bleeding (following hospital discharge);~Ipsilateral lower extremity arterial emboli;~Ipsilateral deep vein thrombosis;~Access site-related vessel laceration;~Access site wound dehiscence;~Localized access site infection treated with intramuscular or oral antibiotics;~Arteriovenous fistula not requiring treatment;~Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection;~Pseudoaneurysm not requiring treatment;~New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair;~Ipsilateral pedal pulse diminished by two grades or transiently lost."|30 days +/- 7 days||||participants|||Number
1396449|NCT01297322|Secondary|Procedure Success|Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days|30 days +/- 7 days||||participants|||Number
1396452|NCT01297322|Secondary|Time to Discharge Eligibility (TTDE)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team|Up to 2 days||||hours||Standard Deviation|Mean
1396453|NCT01297322|Secondary|Time to Ambulation (TTA)|Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding|Up to 1 day||||hours||Standard Deviation|Mean
1396454|NCT01297322|Primary|Rate of Combined Access Site-related Major Complications|"Primary safety endpoint~Access site-related bleeding requiring transfusion;~Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft);~New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.;~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization;~New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair;~Permanent access site-related nerve injury. (> 30 days)"|30 days +/- 7 days||||participants|||Number
1396455|NCT01297322|Primary|Time to Hemostasis (TTH)|Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.|Up to 1 hour||||minutes||Standard Deviation|Mean
1396456|NCT01297283|Secondary|Evaluation of Factors Such as Device Rotation, Device Fixation, Device Side Facing the Skin, Position of Lead Loops in the Pocket, Use of Antiseptic Solution, Skin Type, Body Mass Index on the Quality of Leadless ECG.|"The following factors will be evaluated to investigate whether they influence the LECG quality:~device position (subcutaneous, submuscular, etc)~device rotation~device fixation~device side facing the skin~position of lead loops in the pocket~use of antibiotics in the pocket~skin type (loose, normal, firm)~body mass index (BMI)~The endpoints will be:~describe R wave amplitude values~describe proportion of patients with P wave visible on intrinsic LECG strips recorded at 1-Month FU."|30 to 120 days|||||||
1396457|NCT01297283|Secondary|Effect of Posture Changes and Artifact-inducing Maneuvers on the LECG Quality.|"The intrinsic R wave amplitude and P waves visibility will be taken to evaluate the effect of posture changes and artifact-inducing maneuvers on the quality of LECG at the 1-Month Follow-Up visit (LECG vector with best combination of the highest R wave and most visible P wave).~The endpoints will be R wave amplitude and P wave visibility in different positions (meaning visible or not visible in both positions).~R wave changes and proportion of patients with stable P waves visibility at lying position versus other positions will be calculated by an independent reviewer."|30 to 120 days|||||||
1396458|NCT01297283|Secondary|Quality of LECG in New Devices Versus Device Replacements.|"The two following parameters will be used to compare the quality of LECG in new implants versus device replacements at PHD and 1-Month on the same LECG vector:~Intrinsic R wave amplitude~P waves visibility The LECG vector at PHD with best combination of the highest R wave and most visible P wave will be selected.~R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.~The endpoints will be:~comparison of mean R wave values at PHD and 1-month~comparison of proportion of patients with P wave visible at PHD and 1-month."|30 to 120 days|||||||
1396459|NCT01297283|Secondary|Evaluation of the Stability of LECG Performance Over Time.|"Two parameters will be used to evaluate LECG changes between PHD and 1-Month on the same LECG vector: intrinsic R wave amplitude and P waves visibility (selection the LECG vector at PHD with best combination of the highest R wave and most visible P wave).~R wave amplitude measurements as well as P wave visibility assessment will be done by the independent reviewer.~The endpoints evaluated are:~mean R wave changes from PHD to 1-month~proportion of patients with stable P wave visibility at PHD and 1-Month (meaning both visits visible or both visits not visible)."|30 to 120 days|||||||
1396460|NCT01297283|Secondary|Evaluation of the Possibility to Determine Ventricle Capture by an Independent Reviewer.|"The investigator will simulate loss of capture (LOC) at 1-Month Follow-Up visit by printing strips of LOC in both ventricular leads, LOC in LV lead only, LOC in RV lead only, no LOC. One strip randomly selected among them by the study manager will be submitted to an independent reviewer. With help of the PHD template LECG strips (intrinsic, RV paced, LV paced, BiV paced) of this patient, he/she will determine which lead is capturing.~The endpoint is the proportion of correct classifications of ventricular capture done by then independent reviewer of LECG."|30 to 120 days|Proportion of Patients Correctly Classified|||proportion||95% Confidence Interval|Number
1396461|NCT01297283|Primary|Proportion of Patients With LECG Performing Clinically Equivalent to PECG During Standard Pacemaker Follow-up Procedure.|During CRT-P standard follow-up, ECG is used to determine atrial, left and right ventricular pacing thresholds. As primary endpoint, we will consider the proportion of patients for which for all leads LECG provides pacing threshold values that are clinically equivalent to those obtained with PECG taken as reference. The analysis will be performed on data collected at the 1-Month Follow-Up visit when the device pocket healing process is completed. Clinical equivalence will be defined as the LECG threshold values being no more than 0.5 volts different from the PECG threshold values.|30 to 120 days||||proportion||95% Confidence Interval|Number
1396462|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396463|NCT01297270|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396585|NCT01295814|Secondary|Interstitial Cystitis Symptom Index (ICSI)|Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)|Baseline/ 12 weeks||||units on a scale||Standard Deviation|Mean
1396464|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396465|NCT01297270|Secondary|AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396466|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396467|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range 12 weeks post-treatment when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396468|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients do not have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396469|NCT01297270|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at end of treatment (EOT) when patients have sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
1396470|NCT01297270|Secondary|Early Treatment Success (ETS)|Percentage of participants with early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|Week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants|||Number
1396471|NCT01297270|Secondary|Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|"Percentage of participants with sustained virologic response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.~Hepatitis C virus Ribonucleic acid (HCV RNA)"|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication and had SVR data at week 24.|||percentage of participants||95% Confidence Interval|Number
1396472|NCT01297270|Primary|Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1396473|NCT01297257|Secondary|In-hospital MACE (Major Adverse Cardiac Event)||stent implantation until hospital discharge (average 1-3 days)||||Participants|||Number
1396474|NCT01297257|Primary|Delivery Success|The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.|stent implantation until hospital discharge (average 1-3 days)||||stents|Participants||Number
1396475|NCT01297062|Secondary|Plasma Exenatide Concentrations at Steady State on Day 1, 2 and 3|The plasma exenatide concentration at steady state was descriptively summarized by geometric mean, standard error, and its effect on placebo-adjusted change from baseline in QTcP was assessed.|Baseline, Day 1, 2, and 3|Evaluable Population. No imputation for missing value was used. Day 1, 2, and 3 exenatide concentration < LLOQ was set to missing.|||pg/mL||Standard Error|Geometric Mean
1396476|NCT01297062|Secondary|Number of Subjects With Increase of QTcP Interval From Baseline >30msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with increase of QTcP interval from baseline >30 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Baseline, Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.|||particpants|||Number
1396477|NCT01297062|Secondary|Number of Subjects With QTcP Interval >450msec at Any Timepoint on Any Day in Exenatide and Placebo|Number of subjects with QTcP > 450 msec at any timepoint on any day was summarized by frequency for exenatide and placebo.|Day 1, 2, or 3|Evaluable Population. No imputation for missing value was used.|||participants|||Number
1396478|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1200h (3 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
1396479|NCT01297062|Secondary|Assay Sensitivity of Moxifloxacin at 1100h (2 Hour Post-administration of Moxifloxacin) on Day 2|Change from baseline in QTcP was analyzed by a MMRM between moxifloxacin and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
1396481|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 3|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
1396482|NCT01297062|Primary|Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a MMRM between exenatide and placebo.|Baseline, Day 2|Evaluable Population. No imputation for missing value was used.|||msec||90% Confidence Interval|Least Squares Mean
1396483|NCT01297062|Primary|Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL)|Factors in QT correction formulas were first estimated using pre-therapy data. The most appropriate correction method (QTcP) minimized the mean squared individual QTc/RR regression slope with on-exenatide data. Adequacy of correction was validated with on-placebo data. Change from baseline in QTcP was analyzed by a mixed-effects model for repeated measures (MMRM) between exenatide and placebo.|Baseline, Day 1|Evaluable Population included all ITT subjects who completed all ECG assessment periods and have valid ECG measurements and no vomiting in any ECG data extraction window. No missing value was imputed.|||msec||90% Confidence Interval|Least Squares Mean
1396484|NCT01296841|Secondary|Clinic Appointment Wait Time|The investigators recorded clinic appointment wait time duration in minutes|Clinic Visit||||minutes||Standard Deviation|Mean
1396485|NCT01296841|Secondary|Clinic Appointment Duration|The investigators recorded appointment duration in minutes.|Clinic Visit|Pilot.|||Minutes||Standard Deviation|Mean
1396486|NCT01296841|Primary|Patient Clinical Experience|We used a validated Ware Specific Visit Questionnaire to assess patients’ satisfaction with their clinic-visit encounter. This is a 14-item questionnaire on doctor–patient interaction including factors such as attention to complaints, technical skills, and personal manner (courtesy,and ease of appointment scheduling and is based on a five-point Likert scale (1 excellent to 5 poor). Patients completed the questionnaire at the time of the visit. The 14 item scores were individually scored and then averaged to provide the final overall value.|Clinic Visit|per protocol|||units on a scale||Standard Deviation|Mean
1396487|NCT01296815|Secondary|Safety|Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.|12 months|||||||
1396488|NCT01296815|Primary|Number of Participants With Complete Response|Complete response will be assessed according to RECIST criteria|12 months||||participants|||Number
1396489|NCT01296763|Secondary|Number of Years From Cycle 1, Day 1 On-Study to Date of Death|The overall survival of subjects with locally advanced and/or metastatic pancreatic cancer treated with Irinotecan, Cisplatin, Olaparib, with escalation to the addition of Mitomycin-C. Survival from cycle 1, day 1 on-study to date of death was assessed.|5 years||||years (survival) from C1D1 to death||Full Range|Mean
1396490|NCT01296763|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity to Determine the Maximum Tolerated Dose (MTD)|"1.Phase I - Assess the safety and toxicities of IC with Olaparib escalating to ICM with Olaparib in patients with locally advanced and metastatic pancreatic cancer and determine the phase 2 dose. The number of subjects who experienced a dose limiting toxicity was assessed.Dose-limiting toxicity (DLT) is defined as any of the following study drug-related events experienced during Cycle 1:~Thrombocytopenia with platelets <25,000 x106/l > 7 days. Grade 4 neutropenia lasting ≥7 days. Grade 3 or 4 febrile neutropenia. Grade 3 or greater non-haematological toxicities; excluding grade 3 diarrhoea, nausea or vomiting despite adequate treatment and grade 3 fatigue, lethargy and GGT elevation.~Delay of >2 weeks for next scheduled IC/ICM for reasons of toxicity."|2 years|Number of subjects who experienced a dose limiting toxicity, as defined in the protocol.|||participants|||Number
1396491|NCT01296698|Secondary|Participant Score for Product Convenience|Participants are asked to rate how convenient the product is to use, on a scale of 1-5, where 1=not at all convenient and 5=extremely convenient.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
1396492|NCT01296698|Secondary|Participant Score for Change in Perception|Participants are asked to rate how their opinion has changed since the first time they used it, on a score of 1-5, where 1=I like it much less now and 5=I like it much more now.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
1396493|NCT01296698|Secondary|Participant Score for Speed of Action|Participants are asked to rate the product for speed of action, on a scale of 1-9, where 1=extremely slow and 9=extremely fast.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
1396494|NCT01296698|Secondary|Participant Score for Product Effectiveness in Dealing With Cravings|Participants are asked to rate the product in its effectiveness for dealing with cravings, on a scale of 1-5, where 1=not at all effective, and 5=extremely effective.|through 12 Weeks|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
1396495|NCT01296698|Secondary|Participant Score for General Perception of the Product|Participants are asked to rate their general perception of the investigational product on a scale of 1-10, where 1=very poor and 10=excellent.|through Week 12|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Units on a scale||Standard Deviation|Mean
1399646|NCT01265550|Secondary|Number of Successful Participants With Functional Vomiting|Presence of functional vomiting as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1396496|NCT01296698|Secondary|Highest Rating of Increased Appetite on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Increased Appetite on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
1396497|NCT01296698|Secondary|Highest Rating of Insomnia on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Insomnia on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
1396498|NCT01296698|Secondary|Highest Rating of Dysphoric or Depressed Mood on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Dysphoric or Depressed Mood on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
1396499|NCT01296698|Secondary|Highest Rating of Anxiety on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Anxiety on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
1396500|NCT01296698|Secondary|Highest Rating of Difficulty Concentrating on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Difficulty Concentrating on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and completed the questionnaire.|||Percentage of Participants|||Number
1396501|NCT01296698|Secondary|Highest Rating of Restlessness on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Restlessness on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
1396502|NCT01296698|Secondary|Highest Rating of Irritability/Frustration/Anger on a Categorical Scale|Participants are asked if during the last 24 hours they experienced Irritability/Frustration/Anger on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
1396503|NCT01296698|Secondary|Highest Rating of Desire/Urge to Smoke on a Categorical Scale|Participants are asked if during the last 24 hours they experienced the Desire/Urge to Smoke on a 5-grade categorical scale from Not at all to Extremely so.|within 12 Weeks|Analysis was limited to participants who used study medication at least once and who completed the questionnaire.|||Percentage of Participants|||Number
1396504|NCT01296698|Secondary|Percentage of Participants With High Usage|Percentage of participants who used more than four doses in any one-hour period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.|||Percentage of Participants|||Number
1396505|NCT01296698|Secondary|Percentage of Participants With High Dosage|Percentage of participants who used more than 64 doses in any one-day period.|within 12 Weeks|Analysis was limited to data collected from participants who had used study medication at least one day.|||Percentage of Participants|||Number
1396506|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 6|Analysis was limited to data collected from participants at Week 6. Analysis of data for the remainder of the study weeks was not possible because the trial terminated prematurely due to a technical issue (randomization error).|||Daily Doses||Standard Deviation|Mean
1396507|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 5|Analysis was limited to data collected from participants at Week 5.|||Daily Doses||Standard Deviation|Mean
1396508|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 4|Analysis was limited to data collected from participants at Week 4.|||Daily Doses||Standard Deviation|Mean
1396509|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 3|Analysis was limited to data collected from participants at Week 3.|||Daily Doses||Standard Deviation|Mean
1396510|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 2|Analysis was limited to data collected from participants at Week 2.|||Daily Doses||Standard Deviation|Mean
1396511|NCT01296698|Secondary|Mean Number of Daily Doses|Mean number of daily doses by study week.|Week 1|Analysis was limited to data collected from participants at Week 1.|||Daily Doses||Standard Deviation|Mean
1396512|NCT01296698|Secondary|Number of Participants With 7-day Point Prevalence Abstinence|Number of participants with carbon monoxide (CO)-verified self-reported 7-day point prevalence abstinence from smoking at Weeks 2, 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error).|||Participants|||Number
1396513|NCT01296698|Secondary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self report of continuous abstinence from smoking from Week 2 to Weeks 4, 6, 12, 16, and 26.|through Week 26|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Participants|||Number
1396514|NCT01296698|Primary|Number of Participants With Continuous Smoking Abstinence|Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.|through Week 6|The study was terminated prematurely due to a technical issue (randomization error) and no data are available.|||Participants|||Number
1396515|NCT01296672|Secondary|T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC|Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer|Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days|Receiving biopsy|||Ratio||95% Confidence Interval|Number
1397076|NCT01290718|Secondary|Overall Survival|Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
1396516|NCT01296672|Secondary|PCA3 (Prostate Cancer Antigen 3)Score AUC|Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)|Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day|Receiving biopsy|||ratio||95% Confidence Interval|Number
1396517|NCT01296672|Primary|Pre/Post Ratio PSA Area Under the Curve (AUC)|Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.|Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months|Patients with biopsy|||Ratio||95% Confidence Interval|Number
1396518|NCT01296646|Secondary|Percent Days Abstinent|Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.|12 weeks||||percentage of days||Standard Deviation|Mean
1396519|NCT01296646|Primary|Percent Heavy Drinking Days|Percentage of heavy drinking days as derived from the Timeline Follow-back (TLFB) for the entire medication period. A heavy drinking day is defined as 5 or more standard drinks for a man and 4 or more standard drinks for a woman. A standard drink is 12-14 grams of ethanol or the amount contained in a 12 oz beer, 5 oz of wine or 1 1/2 oz of hard liquor.|12 weeks||||percentage of days||Standard Deviation|Mean
1396520|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <6.5%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||percentage of participants|||Number
1396521|NCT01296412|Secondary|Percentage of Participants Reaching A1C Goal of <7.0%||Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||percentage of participants|||Number
1396522|NCT01296412|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline at Week 26 is defined as Week 26 minus Week 0.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1396523|NCT01296412|Primary|Change From Baseline in Hemoglobin A1c (A1C)|A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.|Baseline and Week 26|Per-protocol population defined as participants who had a measurement at baseline and a measurement after at least 24 weeks (i.e., 168 days) of treatment, and did not have any major protocol violations.|||percent||95% Confidence Interval|Least Squares Mean
1396524|NCT01296360|Secondary|Rate of Subjects With Solicited AEs for up to 7 Days Following the Booster Dose. Severity and Duration.||7 days|||||||
1396525|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month|||||||
1396526|NCT01296360|Secondary|Rate of Subjects With SAEs and Medically Attended AEs Within 1 Month Following the Booster Dose. Severity, Duration and Relationship to Vaccinations.||1 month|||||||
1396527|NCT01296360|Secondary|Rate of Subjects With Unsolicited AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and Relationship to Vaccinations.||36 months|||||||
1396528|NCT01296360|Secondary|Rate of Subjects With SAEs (Serious Adverse Events) Following Immunization and Medically Attended AEs (Adverse Events) up to Months 12, 24 and 36 After the First IXIARO Vaccination in IC51 323 With and Without Booster Vaccination. Severity, Duration and||36 months|||||||
1396529|NCT01296360|Secondary|GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination||36 months|||||||
1396530|NCT01296360|Secondary|GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose||1 month|||||||
1396531|NCT01296360|Secondary|Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose||1 month|||||||
1396532|NCT01296360|Primary|SCRs (Seroconversion Rate) as Defined by Percentage of Subjects With Plaque Reduction Neutralization Test Titers of>1:10 at 1 Month After the Booster Dose||1 month post booster|Intent-to-treat Population: primary analysis population for the immunogenicity analyses; defined as all subjects randomized|||percentage of subjects||95% Confidence Interval|Number
1396533|NCT01296347|Secondary|Incidence of Pain|"Measures in pain include:~Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine' Brief Pain Inventory (BPI) Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)"|3, 6 and 12 months|||||||
1396534|NCT01296347|Secondary|Incidence of Side-effects|The presence of nausea, vomiting, itching, sedation, feeling lightheaded or vivid dreams will be recorded at the above time points|24 hours, 48 hours|||||||
1396535|NCT01296347|Secondary|Sensory Testing|"Hypoaesthesia: light touch of the blunt end of a paintbrush was felt less precisely, than in healthy tissue.~Hyperalgesia: the pain induced by a sterile neurotip, applied perpendicular to the skin is felt abnormally strongly, in comparison to the contralateral side.~Static allodynia: the application of a Von Frey hair number 14. (8g) was unpleasant, in comparison to the contralateral side.~Dynamic allodynia: three successive gentle strokes of an 8 mm-wide paintbrush over a 40 mm distance, is unpleasant, in comparison to the contralateral side."|6 weeks, 6 months, 12 months|||||||
1396536|NCT01296347|Secondary|Analgesic Consumption|Analgesia consumption will be measured post-operatively and at the time points stated above. The cumulative dose of opioid, measured in oral morphine equivalents, will be obtained from the time of the patient’s arrival in recovery (T0), to 24 hours post-operatively (T0 + 24) and to 48 hours post-operatively (T0 + 48). Analgesia consumption will also be measured at six weeks, three months, six months and one year. All analgesia will be converted to oral morphine equivalents (in mg) by multiplication by a factor depending on the analgesia taken (codeine 0.15, tramadol 0.17, oxycodone 2)|24 hours, 48 hours, 6 weeks, 3, 6 and 12 months|||||||
1396537|NCT01296347|Primary|The Incidence of Pain|"Measures in pain include:~Numeric pain score of 0 to 10. Zero denotes 'no pain'; 10 denotes 'pain as bad as you can imagine'"|6 weeks after surgery||||units on a scale||Standard Deviation|Mean
1396538|NCT01296152|Secondary|Regulatory T Cells (Tregs) at Baseline, Week 4 and Week 12 Using Flow Cytometry in Freshly Thawed PBMCs.|This evaluates the effect of MPA on Tregs at baseline (Day 0), week 4 and week 12 using flow cytometry in freshly thawed PBMCs. A summary of CD4+ and cluster of differentiation 8 (CD8+) anchored T-cell subsets by study week, in percent that express the marker of interest, is presented here together to provide all results pertaining to this objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 21 participants with available data were analyzed.|||Percent CD4/CD8 cells expressing marker||Inter-Quartile Range|Median
1396539|NCT01296152|Secondary|CMI to HIV and the Common Opportunistic Agent VZV Using the Lymphocyte Proliferation Assay (LPA).|This evaluates the effect of MPA on CMI to HIV and VZV. This outcome was measured at Baseline Before DMPA (Day 0) and After DMPA (Weeks 4 and 12) using the Lymphocyte Proliferation Assay (LPA). The data table shows a summary of LPA assay results by study week with stimuli HIV and VZV. Proliferation results are reported as a stimulation index (SI) which represents the ratio of the stimulated counts per minute to unstimulated control counts per minute.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.|||SI Ratio||Inter-Quartile Range|Median
1396540|NCT01296152|Secondary|Cell Mediated Immunity (CMI) to HIV and the Common Opportunistic Agent Varicella-zoster Virus (VZV) Using the Enzyme-linked Immunospot (ELISPOT) Assay.|This evaluates the effect of MPA on CMI to HIV and VZV at baseline before DMPA (day 0) and after DMPA (weeks 4 and 12) . Cytokines are interferon-gamma (IFN-gamma) and interleukin 2 (IL-2), and Stimuli are HIV and VZV. Summary of adjusted ELISPOT assay results is in spot forming cells (SFC)/10^6 peripheral blood mononuclear cells (PBMC) by study weeks 0, 4 and 12. The outcome measures of IFN-gamma and IL-2 measured for HIV and VZV are presented here together to provide all results pertaining to the same objective in a single data table.|Day 0, Weeks 4 and 12|All 24 participants included in the primary analyses were eligible for this secondary objective. 22 participants with available data were analyzed.|||SFC/10^6 PBMC||Inter-Quartile Range|Median
1396541|NCT01296152|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL.|This evaluates the short-term impact of MPA on virologic suppression in participants taking LPV/r who have received a dose of DMPA by measuring percentage of participants with HIV-1 RNA levels <400 copies/mL at day 0 (prior to DMPA injection) and at weeks 2, 4, 8 and 12 (after DMPA injection). An FDA-approved HIV-1 RNA assay with a lower limit of detection of 75 copies/mL or less was required and the same HIV-1 RNA assay was required to be performed for each participant across all study visits. The Roche COBAS AmpliPrep/TaqMan HIV-1 and Abbott RealTime HIV-1 tests were used.|Day 0, Weeks 2, 4, 8, and 12|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the HIV-1 RNA draw (see N for each week in table below).|||Percent of Participants|||Number
1396542|NCT01296152|Secondary|Percentage of Participants With Menstrual Irregularities of Grade 1 and Higher Deemed Possibly, Probably or Definitely Related to Study Treatment.|This evaluates toxicity and safety of concomitant medication of DMPA and LPV/r, focusing specifically on the adverse event (AE) menstrual irregularities with abnormal vaginal bleeding. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study's co-chairs.|From day 0 to week 12|This analysis focuses on the 24 participants eligible for the PK analyses.|||Percent of Participants|||Number
1396543|NCT01296152|Secondary|RTV PK Parameter T1/2.|This evaluates the effect of MPA on the PK parameter T1/2 of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC. For one participant at day 0, T1/2 results were not estimated.|||hour||Full Range|Median
1396544|NCT01296152|Secondary|RTV PK Parameter CL/F.|This evaluates the effect of MPA on the PK parameter CL/F of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||L/hour||Full Range|Median
1396545|NCT01296152|Secondary|RTV PK Parameter Tmax.|This evaluates the effect of MPA on the PK parameter Tmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||hour||Full Range|Median
1396546|NCT01296152|Secondary|RTV PK Parameter Cmax.|This evaluates the effect of MPA on the PK parameter Cmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
1396547|NCT01296152|Secondary|RTV PK Parameter Cmin.|This evaluates the effect of MPA on the PK parameter Cmin of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
1396548|NCT01296152|Secondary|Ritonavir (RTV) PK Parameter AUC0-12h.|This evaluates the effect of MPA on the PK parameter AUC0-12h of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. Blood samples were drawn for RTV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants eligible for the primary PK outcome of LPV AUC.|||ng*h/mL||Full Range|Median
1396549|NCT01296152|Secondary|LPV PK Parameter T1/2.|This evaluates the effect of MPA on the secondary LPV PK parameter T1/2 obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||hour||Full Range|Median
1396586|NCT01295814|Primary|O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score|Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)|Baseline/12 Weeks||||units on a scale||Standard Deviation|Mean
1396550|NCT01296152|Secondary|LPV PK Parameter CL/F.|This evaluates the effect of MPA on the secondary LPV PK parameter CL/F obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||L/hour||Full Range|Median
1396551|NCT01296152|Secondary|LPV PK Parameter Tmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Tmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||hour||Full Range|Median
1396552|NCT01296152|Secondary|LPV PK Parameter Cmax.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
1396553|NCT01296152|Secondary|LPV PK Parameter Cmin.|This evaluates the effect of MPA on the secondary LPV PK parameter Cmin obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4.|Day 0 and Week 4|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of LPV AUC.|||ng/mL||Full Range|Median
1396554|NCT01296152|Secondary|MPA PK Parameter Half-Life (T1/2) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter T1/2 based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC. A minimum of three observations in the elimination phase was required to determine T1/2 and therefore results are presented for 22 participants.|||week||Full Range|Median
1396555|NCT01296152|Secondary|MPA PK Parameter Clearance (CL/F) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter CL/F based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||L/week||Full Range|Median
1396556|NCT01296152|Secondary|MPA PK Parameter Time to Cmax (Tmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Tmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||week||Full Range|Median
1396557|NCT01296152|Secondary|MPA PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||ng/mL||Full Range|Median
1396558|NCT01296152|Secondary|MPA PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on MPA Levels.|This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmin based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12.|0, 2, 4, 6, 8, 10, and 12 weeks|The analysis population is the 24 A5283 participants who took DMPA with LPV/r and were eligible for the primary PK outcome of MPA AUC.|||ng/mL||Full Range|Median
1396559|NCT01296152|Secondary|Percentage of Participants With Progesterone Levels Less Than the Lower Limit of Quantification (LLQ).|This evaluates the suppression of ovulation due to the potential PK interaction between DMPA and LPV/r. The LLQ of progesterone is 0.5ng/mL. The threshold for suppression of ovulation is 5ng/mL.|0, 2, 4, 6, 8, 10, and 12 weeks|All 24 participants included in the primary analyses were eligible for this secondary objective, however participants occasionally missed the progesterone draw (see N for each week in table below).|||Percent of Participants|||Number
1396560|NCT01296152|Primary|AUC0-12hour for LPV at Baseline (Day 0) Before DMPA Administration and at Week 4 (Four Weeks After DMPA Administration)|This evaluates the effect of DMPA on LPV PK parameter AUC by comparing PK AUCs of LPV from 0 to 12 hours obtained at study Day 0 (before DMPA was administered) with PK AUCs of LPV from 0 to 12 hours at study Week 4 (4 weeks after DMPA was administered). Blood samples were drawn for LPV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4.|Day 0 and Week 4|All participants eligible for the first primary PK outcome measure (MPA AUC0-12weeks) were included in this second primary outcome measure looking at LPV AUC0-12hours at Day 0 and week 4.|||ng*h/mL||Full Range|Median
1396561|NCT01296152|Primary|Medroxyprogesterone Acetate (MPA) Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-12weeks)|This evaluates the effect of lopinavir/ritonavir (LPV/r) on pharmacokinetic parameter AUC of MPA by looking at the MPA AUC from day 0 to week 12. AUC0-12weeks was calculated using single MPA concentrations sampled immediately prior to DMPA administration on day 0, and at 2, 4, 6, 8, 10 and 12 weeks after administration of the single DMPA dose.|Day 0, Weeks 2, 4, 6, 8, 10 and 12|One participant was excluded from all PK analyses for taking a prohibited medication with potential to interfere with PK assessments. For another participant who missed week 10 and 12 visits, a modelling approach was used to estimate the week 12 MPA level.|||ng*wk/mL||Full Range|Median
1396562|NCT01296035|Secondary|Adverse Events, Measured by Active Version of the NCI Common Toxicity Criteria|Adverse events (AEs) will be recorded during the duration of the trial, whether or not the events are considered related to medication. All AEs considered to be related to trial therapy will be followed for resolution, including into the post-treatment period.|Every 4 weeks while on-study, up to 24 weeks|Please see results section. In short, there were 3 serious adverse events (1 thromboembolic, 1 hypomagnesemia, 1 bowel obstruction). Additional adverse events included (in decreasing order) rash, fatigue, anemia, edema, thrombocytopenia, abdominal pain, epistaxis, hypocalcemia, and calciphylaxis|||participants|Participants||Number
1396563|NCT01296035|Primary|Overall Response Rate, Measured by RECIST Criteria|Documentation of known measurable or evaluable disease parameters after every 2 cycles of treatment. If any patient is withdrawn for the study prior to completion of therapy a repeat evaluation will be done at that time.|Every 8 weeks while on-study|Due to the small number of participants, data were not collected as planned||||||
1396564|NCT01295905|Secondary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.|||Units on a scale||Standard Deviation|Mean
1396565|NCT01295905|Secondary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.|||Units on a scale||Standard Deviation|Mean
1396566|NCT01295905|Secondary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, lenses replaced daily|Per protocol.|||Units on a scale||Standard Deviation|Mean
1396567|NCT01295905|Primary|Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity|Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.|3 months of wear, lenses replaced daily|Per protocol.|||eyes|Participants||Number
1396568|NCT01295879|Secondary|Recurrence of Kidney Stones||8 weeks||||# of stone recurrences|||Number
1396569|NCT01295879|Secondary|Change in 24 Hour Urine Supersaturation of Calcium Oxalate|Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones|8 weeks||||(unitless)||Standard Deviation|Mean
1396570|NCT01295879|Primary|Change in 24 Hour Urine Calcium|Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones|8 weeks||||mg/day||Standard Deviation|Mean
1396571|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At 6 months||||participants|||Number
1396572|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At 6 months||||participants|||Number
1396573|NCT01295840|Secondary|Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector|To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector|At enrollment||||participants|||Number
1396574|NCT01295840|Secondary|Number of Patients With PNS in All Vectors|To calculate the number of patients that exhibit PNS in all traditional vector|At enrollment||||participants|||Number
1396575|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|At 6 months||||number of vectors|Participants||Number
1396576|NCT01295840|Secondary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)||||number of vectors|Participants||Number
1396577|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|6 months post-implant||||volts||Standard Deviation|Mean
1396578|NCT01295840|Secondary|Capture Threshold|"Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.~Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode."|Enrollment visit (in the seven days after implantation of the device)||||volts||Standard Deviation|Mean
1396579|NCT01295840|Secondary|Cardiac Output (CO) With Different Configurations at Enrollment|Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.|Enrollment visit (in the seven days after implantation of the device)||||L/min||Standard Deviation|Mean
1396580|NCT01295840|Secondary|Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors|"In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors.~The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC."|At enrollment||||percentage of difference of CO||Standard Deviation|Mean
1396581|NCT01295840|Primary|Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.||Enrollment visit (in the seven days after implantation of the device)||||participants|||Number
1396582|NCT01295814|Secondary|Global Response Assessment (GRA)|"Percent(%) of patients who reported 50% or greater overall improvement in their condition.~Score on a scale range (improvement 0%-100%)"|Measured at12 Weeks||||percentage of participants|||Number
1396583|NCT01295814|Secondary|Pelvic Pain Urgency/Frequency (PUF) Score|Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)|Baseline12 Weeks||||units on a scale||Standard Deviation|Mean
1396587|NCT01295671|Secondary|Preference for Sweet Taste|We evaluated preference for sweet taste using ten solutions ranging in sucrose concentration (%m/v) from 0% (sample 1) to 18% (sample 10). After tasting each solution, participant reported the sample number corresponding to his or her overall favorite.|12 Month|Data missing for 1 subject in SSB group.|||Sample number||Inter-Quartile Range|Median
1396588|NCT01295671|Secondary|Diet Quality: Sugar-Sweetened Beverage Consumption|Diet Quality: Sugar-Sweetened Beverage Consumption - servings per day|12 Month|Data missing for 1 subject in USB group.|||Servings per day||Standard Deviation|Mean
1396589|NCT01295671|Secondary|Body Weight|Body Weight|12 Month|Data missing for 1 subject in ASB group.|||kg||Standard Deviation|Mean
1396590|NCT01295671|Secondary|Diastolic Blood Pressure|Diastolic Blood Pressure|12 Month||||mmHg||Standard Deviation|Mean
1396591|NCT01295671|Secondary|Systolic Blood Pressure|Systolic Blood Pressure|12 Month||||mmHg||Standard Deviation|Mean
1396592|NCT01295671|Secondary|ALT|ALT|12 Month||||U/L||Inter-Quartile Range|Median
1396593|NCT01295671|Secondary|Uric Acid|Uric Acid|12 Month||||mg/dL||Standard Deviation|Mean
1396594|NCT01295671|Secondary|Fibrinogen|Fibrinogen|12 Month||||mg/dL||Standard Deviation|Mean
1396595|NCT01295671|Secondary|hsCRP|hsCRP|12 Month||||mg/L||Inter-Quartile Range|Median
1396596|NCT01295671|Secondary|LDL-C|LDL-C|12 Month||||mg/dL||Standard Deviation|Mean
1396597|NCT01295671|Primary|Ratio of Serum Triglyceride to HDL-cholesterol Concentration (TG:HDLC)||12 Month||||ratio of Triglycerides-to-HDL||Inter-Quartile Range|Median
1396598|NCT01295320|Secondary|Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented||Month 48 to Month 72||||Participants|||Count of Participants
1396599|NCT01295320|Secondary|Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented||Month 48 to Month 72||||Participants|||Count of Participants
1396600|NCT01295320|Secondary|Number of Subjects With Any Suspected Cases of HZ Episodes||Month 48 to Month 72||||Participants|||Count of Participants
1396601|NCT01295320|Secondary|Number of Subjects With Any Fatal SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 48 to Month 72||||Participants|||Count of Participants
1396602|NCT01295320|Secondary|Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 0 to Month 72||||Participants|||Count of Participants
1396603|NCT01295320|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Month 48 to Month 72||||Participants|||Count of Participants
1396604|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|­Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 72|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||mIU/ml||95% Confidence Interval|Geometric Mean
1396605|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|­Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 60|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||mIU/ml||95% Confidence Interval|Geometric Mean
1396606|NCT01295320|Primary|Antigen-specific Antibody (Ab) Concentrations|­Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)|Month 48|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||mIU/ml||95% Confidence Interval|Geometric Mean
1396607|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 72|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||cells/million T-cells||Standard Deviation|Mean
1396608|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 60|The analysis was base don the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||cells/million T-cells||Standard Deviation|Mean
1396651|NCT01294787|Secondary|Trough 24 Hour Post Dose Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose inspiratory capacity after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1396609|NCT01295320|Primary|Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells|­Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)|Month 48|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol and with no elimination criteria during the study).|||cells/million T-cells||Standard Deviation|Mean
1396610|NCT01295281|Secondary|Perception of Discomfort Due to Other Causes|To compare subject’s tolerability with regards to perceived discomfort due to other causes, when using two different urinary catheters 2.0. Frequency of discomfort due to other causes (yes/ no) will be assessed in patient questionnaire. The frequency of discomfort due to other causes will be compared between the treatments. Discomfort due to other causes will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).|At 7 and 14 days after randomization, respectively|||||||
1396611|NCT01295281|Secondary|Perception of Resistance|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396612|NCT01295281|Secondary|Perception of Smoothness|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396613|NCT01295281|Secondary|Perception of Slipperiness|To evaluate subject perception related to the properties of the catheter’s coating/surface, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396614|NCT01295281|Secondary|Perception of Catheter Tip|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396615|NCT01295281|Secondary|Perception of Catheter Adherence|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396616|NCT01295281|Secondary|Perception of Catheter Eyes|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396617|NCT01295281|Secondary|Perception of Stiffness/ Rigidity|To evaluate subject perception related to the physical properties of the catheter, when practising intermittent self catheterization with urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396618|NCT01295281|Secondary|Perception of “Other Discomfort”|To compare subject’s tolerability with regards to perceived “other discomfort”, when using two different urinary catheters; PVC vs. POBE 2.0. Frequency of “other discomfort” (yes/ no) will be assessed in patient questionnaire. The frequency of “other discomfort” will be compared between the treatments. “Other discomfort” will be further specified using 5-graded scale (as for the other variables on the 5-graded scale the difference between the treatments will be calculated for each subject).|At 7 and 14 days after randomization, respectively|||||||
1396619|NCT01295281|Secondary|Presence of Bleeding|To compare subject’s tolerability with regards to presence of bleeding, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396620|NCT01295281|Secondary|Perception of Burning Sensation|To compare subject’s tolerability with regards to perceived burning sensation, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396621|NCT01295281|Secondary|Perception of Pain|To compare subject’s tolerability with regards to perceived pain, when using two different urinary catheters; PVC vs. POBE 2.0. Assessed in patient questionnaire for each subject. A 5-graded scale will be used to determine the perception and the severity of each variable. The difference between the treatments will be calculated for each subject.|At 7 and 14 days after randomization, respectively|||||||
1396716|NCT01294579|Secondary|Conversion Rate of Partial Response in Induction Phase to Complete Response With Maintenance Ofatumumab (FAS)|Rate of conversion from PR in the Induction phase, to CR with maintenance ofatumumab in subjects who have a PR with induction therapy with ofatumumab and bendamustine|Partial response in induction phase up to 24 weeks||||percentage of participants||95% Confidence Interval|Number
1396622|NCT01295281|Primary|Number of Participants With Discomfort|The primary objective of this study is to compare the subject's tolerability, with regards to perceived discomfort, when using two different urinary catheters. Perception of discomfort (yes/ no) will be assessed in patient questionnaire for each subject. The frequency of discomfort will be compared between the treatments.|At 7 and 14 days after randomization, respectively|"Since the study is cross-over, all (104) subjects evaluated both LoFric POBE 2.0 and LoFric PVC. To be able to group and describe the results the Arm/Group Titles are renamed in this section to LoFric POBE 2.0 and LoFric PVC respectively. Each Arm/Group describing the outcome for all 104 subjects (ITT analysis set)."|||participants|||Number
1396623|NCT01295216|Secondary|Change From Baseline in Physical Activity at 12 Months||Baseline and 12 months||||MET/min/week||95% Confidence Interval|Mean
1396624|NCT01295216|Secondary|Change From Baseline in Waist Circumference at 12 Months||Baseline and 12 months||||cm||95% Confidence Interval|Mean
1396625|NCT01295216|Secondary|Change From Baseline in Body Mass Index at 12 Months||Baseline and 12 months||||kg/m2||95% Confidence Interval|Mean
1396626|NCT01295216|Secondary|Change From Baseline in Body Weight at 12 Months||Baseline and 12 months||||kg||95% Confidence Interval|Mean
1396627|NCT01295216|Secondary|Change From Baseline in Food Intake at 12 Months||Baseline and 12 months||||Servings/day||95% Confidence Interval|Mean
1396628|NCT01295216|Primary|Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months|A reduction in systolic and diastolic blood pressure is expected as early as 6 months of intervention and it is expected that this reduction is maintained or even continue to decrease over time|Baseline, 6, 12, and 18 months||||mmHg||95% Confidence Interval|Mean
1396629|NCT01295112|Secondary|The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24|Change in BCVA at Week 24 from baseline|24 weeks||||letters||Standard Deviation|Mean
1396630|NCT01295112|Primary|The Primary Efficacy Endpoint is the Total Number of PRN Bevacizumab Intravitreal Injections Through 24 Weeks||24 weeks||||Participants|||Count of Participants
1396631|NCT01295034|Secondary|CD4+T Cell Count|The change in the CD4+T cell count between the two arms.|baseline and 12 months|Analysis only for participants who completed the study.|||cell/μL||Inter-Quartile Range|Median
1396632|NCT01295034|Primary|25(OH)D Levels|The difference in the percentage of subjects with 25(OH)D levels in the range of 30-60 ng/ml at 12 mo between the two arms.|baseline and 12 months||||Participants|||Count of Participants
1396633|NCT01294917|Secondary|Dryness|This will be assessed by the tear break-up time on the lens surface, measured in seconds.|4 weeks|||||||
1396634|NCT01294917|Secondary|Subjective Lens Wearing Comfort|This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.|4 weeks|||||||
1396635|NCT01294917|Primary|Corneal Staining|Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.|4 weeks|Only subjects that completed all three arms were included in analysis.|||units on a scale||Standard Deviation|Mean
1396636|NCT01294800|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 12 Weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug|||Participants|||Number
1396637|NCT01294800|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 14 weeks|All Participants as Treated population, which included all participants who received at least one dose of study drug|||Participants|||Number
1396638|NCT01294800|Secondary|Change From Baseline in Mean “On” Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|FAS population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.|||Hours/Day||Standard Deviation|Mean
1396639|NCT01294800|Secondary|Percentage of Participants With ≥30% Reduction in “Off” Time at Week 12|The proportion of responders (≥30% Reduction in “Off” Time at Week 12) was analyzed using a generalized linear mixed model with baseline mean OFF time (hours/day) as a covariate and treatment-by-time interaction as a fixed effect, and an unstructured covariance matrix was used to model the correlation among repeated measurements. Responder rates for each treatment arm are presented as are differences from placebo with 95% confidence interval.|Up to 12 Weeks|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.|||Percentage of participants|||Number
1396640|NCT01294800|Primary|Change From Baseline in Mean “Off” Time (Hours Per Day) at Week 12|"The on state is defined as the period of time during which a participant's symptoms of PD improve or disappear following treatment with levodopa (L-dopa) or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements."|Baseline and Week 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.|||Hours/Day||Standard Deviation|Mean
1396641|NCT01294787|Secondary|Exercise Endurance Time Comparison After a Single Dose of QVA149 Versus Placebo|The effect of a single dose of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured with respect to exercise endurance time during sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test).|Day 1|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Seconds||Standard Error|Least Squares Mean
1396642|NCT01294787|Secondary|Exercise Endurance Comparison Between QVA149 and Tiotropium Groups|Effect of QVA149 110/50 µg o.d. compared with tiotropium 18 µg o.d. in patients with moderate to severe COPD with respect to exercise endurance was measured by a sub-maximal constant load cycle ergometry test ((SMETT)cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Seconds||Standard Error|Least Squares Mean
1396643|NCT01294787|Secondary|Leg Discomfort During Exercise Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo on leg discomfort was measured using Borg CR10 Scale® during sub-maximal constant load cycle ergometry test after three weeks treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Error|Least Squares Mean
1396644|NCT01294787|Secondary|Exertional Dyspnea Comparison Between QVA149 and Placebo Groups|"The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using exertional dyspnea Borg CR10 Scale® (After 3 weeks of treatment, before, during and after exercise, patients were asked to rate the intensity of their breathing and leg discomfort using the Borg CR10 Scale®). This scale consists of 12-point score that the participants pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement."|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Error|Least Squares Mean
1396645|NCT01294787|Secondary|Spirometry After Three Weeks of Treatment on Patients Not Exercising|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity post-dose pre-exercise after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1396646|NCT01294787|Secondary|Pulmonary Function Test (FRC) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Functional Residual Capacity (FRC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1396647|NCT01294787|Secondary|Pulmonary Function Test (SGaw) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Specific Airway Conductance (SGaw) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Kilo Pascal per second||Standard Error|Least Squares Mean
1396648|NCT01294787|Secondary|Pulmonary Function Test (RV) Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Residual Volume (RV) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1396649|NCT01294787|Secondary|Pulmonary Function Test Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using the pulmonary function test for Slow Vital Capacity (SVC) on day 1 and day 21, at 5 min and 15 min post dose as determined by body plethysmography.|day 1 and day 21|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1396650|NCT01294787|Secondary|Trough 24 Hour Post Dose Forced Expiratory Volume in One Second Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using trough 24 hour post dose Forced Expiratory Volume in one second (FEV1) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1396768|NCT01294306|Primary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response = CR + PR|Up to 2 years||||percentage of subjects|||Number
1396652|NCT01294787|Secondary|Dynamic Inspiratory Capacity Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured using dynamic inspiratory capacity at isotime during sub-maximal constant load cycle ergometry test ((SMETT)a cycle exercise test), after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters||Standard Error|Least Squares Mean
1396653|NCT01294787|Primary|Exercise Tolerance Comparison Between QVA149 and Placebo Groups|The effect of indacaterol and glycopyrronium bromide (QVA149) compared to placebo was measured by exercise endurance time (in seconds) during a sub-maximal constant load cycle ergometry test ((SMETT)which is a cycle exercise test) after three weeks of treatment.|3 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Seconds||Standard Error|Least Squares Mean
1396654|NCT01294748|Secondary|Stent Thrombosis (Definite/Probable)|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|9-months||||percentage of patients|||Number
1396655|NCT01294748|Secondary|Target Lesion Failure (TLF)|Composite endpoint of cardiac death, target-lesion myocardial infarction (Q wave or non-Q wave), and clinically indicated target lesion revascularization|9-months||||percentage of patients|||Number
1396656|NCT01294748|Secondary|Target Vessel Failure (TVF)|Composite endpoint of cardiac death, target-vessel myocardial infarction (Q wave or non-Q wave), and clinically indicated target vessel revascularization|9-months||||percentage of patients|||Number
1396657|NCT01294748|Secondary|Clinically-driven Target Lesion Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel (main branch or side branch). The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches, and the target lesion itself.|9-months||||percentage of patients|||Number
1396658|NCT01294748|Secondary|Total Myocardial Infarct (MI)|"Q-wave MI (QWMI): requires one of the following criteria: development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x ULN elevation of CK levels; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.~Non-Q-wave MI (NQWMI):the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels (≥3 times ULN) in the absence of new pathologic Q waves.~Peri-Procedural MI post PCI:Q or non-Q-wave MI, as defined above, prior to hospital discharge, or CK-MB elevation >3xULN within 48 hours post –PCI, with a normal CK-MB at baseline."|9-months||||percentage of patients|||Number
1396659|NCT01294748|Secondary|Total Mortality||9-months||||percentage of patients|||Number
1396660|NCT01294748|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, MI or repeat revascularization of the target lesion pre-hospital discharge.|8 hours||||percentage of participants|||Number
1396661|NCT01294748|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method.|8 hours||||percentage of participants|||Number
1396662|NCT01294748|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.|8 hours||||percentage of participants|||Number
1396663|NCT01294748|Primary|Major Adverse Cardiac Events (MACE)|Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.|9 months||||percentage of participants|||Number
1396664|NCT01294748|Primary|In-Stent Late Lumen Loss|Measured by the angiographic core laboratory as the difference between the post-procedure MLD in the treated segment (stented region) minus the MLD in the same region at follow-up|9 months||||mm||Standard Deviation|Mean
1396665|NCT01294709|Secondary|Time to 1 mm ST Segment Depression|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The ECG was reviewed and the time to the first ST segment depression of 1 mm was recorded.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of time to 1 mm ST segment depression available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.|||seconds||95% Confidence Interval|Least Squares Mean
1396666|NCT01294709|Secondary|ST Segment Depression at Peak Exercise|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s ECG, symptoms, and arm blood pressure were continuously monitored. The time of peak exercise was considered the time at which the participant reached at least one of the criteria for stopping the treadmill test (evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia). The ECG for that timepoint (time of peak exercise) was evaluated and the amount of ST segment depression was determined.|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable data for assessment of ST segment depression at peak exercise available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.|||mm||95% Confidence Interval|Least Squares Mean
1396667|NCT01294709|Primary|Total Exercise Duration on the Treadmill Test|Bruce (and Modified Bruce) Protocol was used to assess the exercise duration on a treadmill. This protocol consists of a standardized gradual incremental increase in external workload every 3 minutes while the participant’s electrocardiogram (ECG), symptoms, and arm blood pressure were continuously monitored. Regardless of whether the participant believed he or she could continue, the test was discontinued upon evidence of chest discomfort, severe shortness of breath, dizziness, fatigue, ST-segment depression of greater than 2 mm, a fall in systolic blood pressure exceeding 10 mmHg, or the development of a ventricular tachyarrhythmia|2.5 to approximately 2.75 hours post dose of each treatment period|Enrolled participants with evaluable treadmill exercise duration data available. Data from the 600 and 900 mg telcagepant treatments were grouped for comparsion to placebo.|||Seconds||95% Confidence Interval|Least Squares Mean
1396668|NCT01294709|Primary|Number of Participants With Laboratory Adverse Events|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.|||Participants|||Number
1396669|NCT01294709|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.|Up to 10 days post dose in Period 1 and up to 14 days post dose in Period 2|Safety Population which consisted of all enrolled participants who actually received assigned study drug in a particular period . Adverse events are reported by dose taken in a given treatment period and not by randomly assigned treatment sequence.|||Participants|||Number
1396670|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 12|The population consisted of all participants for which WOMAC VA 3.0 data was available at Month 12.|||Percentage of Participants|||Number
1396671|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 9|The population consistated of all participants for which WOMAC VA 3.0 data were available at Month 9.|||Percentage of Participants|||Number
1396672|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 6|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 6.|||Percentage of Participants|||Number
1396673|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 3|The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 3.|||Percentage of Participants|||Number
1396674|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1|Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Month 1|The population consisted of all participants for which a WOMAC VA 3.0 measurement was available at Month 1.|||Percentage of Participants|||Number
1396717|NCT01294579|Secondary|Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS)|The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: > or = to 50% decrease from baseline in target nodules; > or = to 50% decrease in hepatic/splenic nodules and no increase in liver or spleen size; no unequivocal progression in non-target lestions; no new sites of disease.|Baseline up to 24 weeks||||percentage of participants||95% Confidence Interval|Number
1396675|NCT01294696|Secondary|Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1)|Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale.|Baseline (Day 1)|The population consisted of all participants for which WOMAC VA 3.0 data for joint stiffness and limiation in physical function were available at Baseline.|||Percentage of Participants|||Number
1396676|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Month 12|The population consisted of all participants for which a BPI value was avaialble at Month 12.|||Percentage of Participants|||Number
1396677|NCT01294696|Primary|Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline|Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable).|Baseline (Day 1)|The population consisted of all participants for which a BPI value was available at baseline.|||Percentage of Participants|||Number
1396678|NCT01294683|Secondary|Percentage of Participants Who Were Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who were discontinued from the study due to an AE were recorded.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1396679|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1396680|NCT01294683|Secondary|Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event|Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1396681|NCT01294683|Secondary|Percentage of Participants With New Onset of Diabetes|Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an AE related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1396732|NCT01294436|Primary|Mean Change in Seated Systolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mmHg||Standard Deviation|Mean
1396950|NCT01292226|Secondary|Total Mycophenolate Acid (MPA) by Visit and Timepoint|Drug quantification of total MPA (micrograms per milliliter [mcg/mL]) in the plasma was measured at time (T) = 0 minutes (min), 40 mins, and 120 mins.|Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits|ITT population; n=number of samples analyzed.|||mcg/mL|Participants|Standard Deviation|Mean
1396682|NCT01294683|Secondary|Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover).|||Percentage of Participants|||Number
1396683|NCT01294683|Secondary|Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
1396684|NCT01294683|Secondary|Percentage of Participants With Creatine Kinase (CK) >=10 x ULN|Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
1396685|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
1396686|NCT01294683|Secondary|Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN|Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
1396687|NCT01294683|Secondary|Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)|Participants had AST and ALT levels assessed during Period I (4 weeks ) and throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.|Up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III)|All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III.|||Percentage of Participants|||Number
1396688|NCT01294683|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.~Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
1396733|NCT01294436|Primary|Mean Change in Seated Diastolic Blood Pressure|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mmHg||Standard Deviation|Mean
1396951|NCT01292226|Secondary|Percentage of Participants Surviving||Day 1, Weeks 2, 4, 12, 24, and 28|ITT population|||percentage of participants|||Number
1396689|NCT01294683|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|"Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.~Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated."|Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
1396690|NCT01294644|Secondary|Change From Baseline in Body Image Quality of Life Inventory (BIQLI)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
1396691|NCT01294644|Secondary|Change From Baseline in Derriford Appearance Scale 24 (DAS24)||Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
1396692|NCT01294644|Secondary|Change From Baseline in Self-rating of Attractiveness|"Self-rating of attractiveness assesses aspects of appearance from the participant's perspective by a series of 6 questions:~How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 where 1 = Not at all attractive, 5 = Neither attractive nor unattractive and 9 = Extremely attractive.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
1396693|NCT01294644|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 characteristics related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)||2016-01-31|01/2016||||
1396694|NCT01294644|Secondary|Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you currently have under your chin? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. Improvement is defined as any decrease in score and worsened as any increase in score."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||percentage of participants|||Number
1396695|NCT01294644|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||mm||Standard Deviation|Mean
1396696|NCT01294644|Secondary|Change From Baseline in SSRS Scores|"The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.~A positive change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
1396697|NCT01294644|Secondary|Change From Baseline in CR-SMFRS Score|"The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population with available data|||units on a scale||Standard Deviation|Mean
1396698|NCT01294644|Primary|Percentage of Participants With a Subject Self Rating Scale (SSRS) Response|"A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment.~The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
1396699|NCT01294644|Secondary|Percentage of Participants With a CR-SMFRS 2-grade Response|"A CR-SMFRS 2-grade response is defined as at least a 2-point improvement (i.e. 2-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat population; LOCF method was used to impute missing data|||percentage of participants|||Number
1396700|NCT01294644|Primary|Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response|"A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."|Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)|Intent-to-treat (ITT) population which included all randomized participants who had at least one efficacy assessment (CR-SMFRS or Subject Self Rating Scale) at Baseline. Last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants|||Number
1396734|NCT01294436|Primary|Mean Change in Seated Heart Rate|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||beats per minute (bpm)||Standard Deviation|Mean
1399647|NCT01265550|Secondary|Number of Successful Participants With Chronic Idiopathic Nausea|Presence of chronic idiopathic nausea as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1396701|NCT01294592|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization|A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of >=5%) and SAEs.|Up to 2 years|ITT Population|||Participants|||Number
1396702|NCT01294592|Secondary|Exposure to Study Drug|Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.|Up to 2 years|Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date|||days||Standard Deviation|Mean
1396703|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: Would you ask your doctor for the treatment you received in this study? There were three possible responses, including: Yes, No, and Not sure. Response categories included Yes and No or Not Sure, created by grouping together No and Not sure. The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Participants|||Number
1396704|NCT01294592|Secondary|Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|"The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: Overall, how satisfied are you with the treatment and its effect on your urinary problems? There were seven possible responses, including: very satisfied, satisfied, somewhat satisfied, neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied. Response categories were created by grouping together very satisfied, satisfied, and somewhat satisfied responses into the category of Any Satisfaction (AS), and separately grouping neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied responses into the category of Neutral or Any Dissatisfaction (N/AD). The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Participants|||Number
1396705|NCT01294592|Secondary|Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries|BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate [TURP], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.|Up to Month 24|ITT Population|||Participants|||Number
1396706|NCT01294592|Secondary|Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH|"CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS >=3 points from Baseline [Visit 2]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components (Tied for first component), and the number of participants with multiple first-occurring components were summarized by treatment group."|Up to Month 24|ITT Population|||Participants|||Number
1396707|NCT01294592|Secondary|Number of Events of Clinical Progression (CP) of BPH|The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS >=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single >=50% rise from Baseline serum creatinine and a total value >=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.|Up to 2 years|ITT Population. Only those participants at risk for CP at the specified visit were analyzed.|||Events|||Number
1396735|NCT01294436|Primary|Mean Change in Serum Uric Acid|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mg/dL||Standard Error|Mean
1396708|NCT01294592|Secondary|Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|Each participant was asked the following question “If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?”. This response was rated from 0 (“delighted”) to 6 (“terrible”). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Scores on a scale||Standard Error|Least Squares Mean
1396709|NCT01294592|Secondary|Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Scores on a scale||Standard Error|Least Squares Mean
1396710|NCT01294592|Secondary|Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach|Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: >=1 point through >=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: >0 percent, >=10 percent, >=20 percent, >=25 percent, >=30 percent, >=40 percent, and >=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: >=2 points, >=3 points, and percent change >=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.|||Participants|||Number
1396711|NCT01294592|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach|"The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates delighted and 6 indicates terrible. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study."|Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.|||Scores on a scale||Standard Error|Least Squares Mean
1396712|NCT01294579|Secondary|All Deaths by Preferred Term (Safety Set) up to Approximately 30 Months|Deaths were collected and were considered to be an on treatment death up to 60 days post treatment.|Baseline up to approximately 30 months||||participants|||Number
1396713|NCT01294579|Secondary|Pharmacokinetic Profile Which Includes Measuring Blood Levels of Ofatumumab and Bendamustine in Combination and Ofatumumab Alone During Maintenance Treatment and Measuring Blood Levels of Circulating B Cell|Due to recruitment issues, this data analysis was not done per changes in planned analysis. This data was only presented as patient listings. The statistical analysis plan was modified to indicate that Pharmacokinetic/Pharmacodynamic exploratory analyses were not done.|up to 30 months|||||||
1396714|NCT01294579|Secondary|Kaplan-Meier Estimates of Progression Free Survival up to 30 Months (FAS)|Progression Free Survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS events: progression documented between scheduled visits, death before first PD assessment (or death at baseline or prior to any adequate assessments), death between adequate assessment visits. For the PFS analysis, the survival function was estimated using Kaplan-Meier estimates.|Baseline up to approximately 30 months||||months||95% Confidence Interval|Median
1396715|NCT01294579|Secondary|Percentage of Participants With Progression Free Survival (PFS) up to 30 Months (FAS)|Progression free survival (PFS) is defined as the interval between first treatment and disease progression or death due to any cause. PFS criteria: A previously normal node (≤ 1.5 x ≤ 1.0cm), including nodes that were not previously visible, must increase to >2.0 x ≥ 1.5cm; ≥ 50% increase from nadir in the PPD of any target node. The long axis must increase by at least 5 mm and to >2.0cm.; ≥ 50% increase from nadir in the long axis of any target node. The long axis must increase by at least 5 mm and to >2.0 cm.; ≥ 50% increase from nadir in the SPD of target nodes and at least one node should have a long axis >1.5 cm.|Baseline up to approximately 30 months||||percentage of participants|||Number
1396718|NCT01294579|Primary|Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS)|Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the longest diameter. Non-measureable nodes 1.1 to 1.5cm in the longest diameter and >1cm in the short axis at baseline had to regress to ≤ 1cm in the short axis by visual estimation; enlarged spleen or liver (with nodules) must have returned to normal size and nodules disappeared and if bone marrow was involved, infiltrate had to have cleared on repeat biopsy sample. CR was not valid without imaging data. The corresponding 2-sided 95% exact confidence interval (CI) of the response rate was estimated by the Clopper-Pearson method.|Baseline up to 24 weeks||||percentage of participants||95% Confidence Interval|Number
1396719|NCT01294553|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion.|41.4 weeks|ITT Population|||participants|||Number
1396720|NCT01294553|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|41.4 weeks|ITT Population|||participants|||Number
1396721|NCT01294553|Primary|Number of Participants With an Adverse Event|"An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|41.4 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments|||participants|||Number
1396722|NCT01294514|Post-Hoc|Calculate Covidien Respiration Rate Software Accuracy as Mean Error +/- Standard Deviation|The Covidien Nellcor Respiration Rate Software shall calculate respiration rate as mean error of +/- standard deviation.|Overall average|One participant was excluded from the data analysis based on cardiac arrhythmia|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
1396723|NCT01294514|Secondary|The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.|"The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.~The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software"|Participants were monitored on average of 30 minute periods|One participant was excluded from the data analysis based on cardiac arrhythmia|||Breaths Per Minute (BrPM)|||Number
1396724|NCT01294514|Primary|The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.|Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control.|Participants were monitorerd on average of 30 minute period|One participant was excluded from the analysis based on cardiac arrhythmia|||Breaths Per Minute (BrPM)||Standard Deviation|Mean
1396725|NCT01294462|Secondary|Composite of All-cause Mortality, MI or Stroke|Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data|||Percent probability|||Number
1396726|NCT01294462|Secondary|Major and Minor Bleeding|Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data|||Percent probability|||Number
1396727|NCT01294462|Primary|Major Adverse Cardiac Events (MACE)|Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to 12 months|Full Analysis set which includes all randomized patients with available post-randomization efficacy data|||Percent probability|||Number
1396728|NCT01294462|Primary|Major Bleeding|Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.|Ongoing up to12 months|Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data|||Percent probability|||Number
1396729|NCT01294449|Primary|All-Cause Mortality|Outcome measured for total population. Not broken down by indication received.|5 years||||participants|||Number
1396730|NCT01294436|Other Pre-specified|Mean Change in Body Weight|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value|||kg||95% Confidence Interval|Mean
1396731|NCT01294436|Other Pre-specified|Mean Change in HbA1c Levels|To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c|Baseline to Week 52|Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value|||Percent||95% Confidence Interval|Mean
1396736|NCT01294436|Primary|Mean Change in Magnesium|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mEq/L||Standard Error|Mean
1396737|NCT01294436|Primary|Mean Change in Blood Urea Nitrogen (BUN)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||mg/dL||Standard Error|Mean
1396738|NCT01294436|Primary|Mean Change in Aspartate Aminotransferase (AST)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||U/L||Standard Error|Mean
1396739|NCT01294436|Primary|Mean Change in Alanine Aminotransferase (ALT)|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||U/L||Standard Error|Mean
1396740|NCT01294436|Primary|Mean Change in Hematocrit|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit|Baseline to Week 52|Safety Analysis Set, participants with non-missing baseline and week 52 values|||Percent||Standard Error|Mean
1396741|NCT01294436|Primary|Proportion of Participants With At Least One Episode of Hypoglycemia|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia|Long-term treatment up to 52 weeks|Safety Analysis Set|||Percentage of participants|||Number
1396742|NCT01294436|Primary|Proportion of Participants With Serious Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set|||Percentage of participants|||Number
1396743|NCT01294436|Primary|Proportion of Participants With Adverse Events|To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events|Long-term treatment up to 52 weeks|Safety Analysis Set|||Percentage of participants|||Number
1396744|NCT01294423|Secondary|Adjusted Mean Change in Body Weight|To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1396745|NCT01294423|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1396746|NCT01294423|Primary|Adjusted Mean Change in HbA1c Levels|To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.|From Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
1396747|NCT01294397|Secondary|Percent Change From Baseline in Serum C-telopeptide (sCTx) Concentrations||Baseline (Day 8) and Days 22, 29, 85, and 176|Participants with available data at baseline (19) and each time point (indicated by n)|||percent change||Inter-Quartile Range|Median
1396748|NCT01294397|Secondary|Serum Denosumab Concentration||Prior to etanercept and denosumab dose administrations, as applicable, on days 8, 22, and 29|Participants with available data|||μg/mL||Standard Deviation|Mean
1396749|NCT01294397|Secondary|Time to Maximum Serum Concentration (Tmax) of Etanercept||Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available Tmax data|||days||Full Range|Median
1396750|NCT01294397|Primary|Maximum Observed Serum Concentration (Cmax) of Etanercept||Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available Cmax data|||μg/mL||Standard Deviation|Mean
1396751|NCT01294397|Primary|Area Under the Serum Concentration-time Curve From 0 to 168 Hours (AUC0-168) for Etanercept|The AUC0-168 of etanercept was measured when administered alone (assessed from day 1) and after administration with denosumab (assessed from day 22, 14 days after denosumab dosing, close to the time of the maximum observed denosumab serum concentration and corresponding to a time approximately 1 week after maximal pharmacodynamic (PD) effects of denosumab are attained).|Day 1 and day 22; at each time point samples were taken predose and 2, 3, 4, 5, 6 and 8 days postdose.|Participants with available AUC data|||day*μg/mL||Standard Deviation|Mean
1396752|NCT01294384|Secondary|Change From Baseline in Schirmer Test|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||mm||Standard Deviation|Mean
1396952|NCT01292226|Secondary|Percentage of Participants With Graft Loss|An allograft was presumed to be lost if a participant started dialysis and was not able to subsequently be removed from dialysis.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population|||percentage of participants|||Number
1396753|NCT01294384|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale where 0=no staining to 5=severe staining over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Score on a scale||Standard Deviation|Mean
1396754|NCT01294384|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Score on a scale||Standard Deviation|Mean
1396755|NCT01294384|Secondary|Change From Baseline in Tear Break-Up Time (TBUT)|TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Seconds||Standard Deviation|Mean
1396756|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Percentage of participants|||Number
1396757|NCT01294384|Secondary|Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)|Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Percentage of participants|||Number
1396758|NCT01294384|Secondary|Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness|The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||millimeters||Standard Deviation|Mean
1396759|NCT01294384|Primary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.|Baseline, Day 90|Participants from the Intent-to-Treat population, that included all randomized participants.|||Score on a scale||Standard Deviation|Mean
1396760|NCT01294371|Secondary|Participants With Estrogen Deficiency Symptoms|"Estrogen deficiency symptoms include:~hot flashes,~headaches,~palpitations at rest,~insomnia,~fluctuation of mood."|6 months|Full Analysis Set|||participants|||Number
1396761|NCT01294371|Secondary|Percent Compliance to Treatment With Leuprorelin|Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100.|6 months|Participants who received at least one dose of leuprorelin.|||percent compliance||Standard Deviation|Mean
1396762|NCT01294371|Primary|Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment|The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.|6 months|Full Analysis Set included all all patients who had signed the personal authorization form and who administered at least one dose of leuprorelin and who had attended at least one post-baseline visit.|||percentage of participants|||Number
1396763|NCT01294319|Secondary|Post-dexamethasone Cortisol Level||Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight||||mcg/dL||Standard Deviation|Mean
1396764|NCT01294319|Primary|Proportion of Suppressors After Dexamethasone|"All subjects will take 0.25mg dexamethasone as an outpatient between 2300 and 2400h and will then report to the clinic by 0800h next day for the final visit.~At the final visit, cortisol response to dexamethasone suppression was assessed. The cortisol response was dichotomized (suppression vs. non-suppression, using 1.8 ug/dL as the cutoff point) and compared between the two groups,Sedentary Young Adults and Endurance-trained Young Athletes."|cortisol measured between 8 and 9 after dexamethasone was taken between 11 PM and midnight||||Participants|||Count of Participants
1396765|NCT01294306|Secondary|Median Overall Survival|Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.|Up to 2 Years||||Months||95% Confidence Interval|Median
1396766|NCT01294306|Secondary|Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride|Toxicities of Grade 3 or higher Attributed to Akt inhibitor MK2206 plus erlotinib hydrochloride, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Time Frame: Up to 2 years||||participants|||Number
1396767|NCT01294306|Secondary|Median Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||Months||95% Confidence Interval|Median
1396769|NCT01294306|Primary|Disease-control Rate|Disease-control rate defined as response rate + stable disease at 12 weeks. Stable disease must have been achieved for 12 weeks or longer. Response evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|At 12 weeks||||percentage of subjects|||Number
1396770|NCT01294267|Other Pre-specified|Safety Outcomes|"Acute Kidney Injury Network stage 1 kidney injury (ie, an absolute increase in serum creatinine of ≥0.3 mg/dL or percentage increase of 150%–200% from baseline.~A decline in neurocognitive function, as defined by a decrease in MMSE ≥2 points from the baseline score, after the procedure."|30 day||||Participants|||Count of Participants
1396771|NCT01294267|Secondary|Clinical Outcomes|Morbidity and Mortality, as determined by clinical metrics and validated by tests during and immediately post VT Mapping and ablation procedure with cardiac monitoring in hospital and one Month [30 days] follow up telephone interview to assess symptoms, side effects and medication use.|1 Month post ablation Follow up||||Participants|||Count of Participants
1396772|NCT01294267|Primary|Number of Participants With Procedural Success|Satisfactory hemodynamic status during the ablation procedure [during VT Mapping and Ablation Procedure], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System|Inpatient Admission||||Participants|||Count of Participants
1396773|NCT01294241|Secondary|Percentage of Wound Epithelialization at Day 14±1|The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 14±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.|Day 14±1|As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.|||Percentage of wound epithelialization|Wounds/wound halves|Full Range|Median
1396774|NCT01294241|Secondary|Percentage of Wound Epithelialization at Day 7±1|The secondary endpoint was the intra-individual difference in median percentage of wound epithelialization at Day 7±1. Sizes of wound areas were measured using a digital wound evaluation program from the EB Center at the Department of Dermatology, University Medical Center Freiburg.|Day 7±1|As 2 participants received 2 cycles of treatment each, 12 wounds were treated with study medication.|||Percentage of wound epithelialization|Wounds/wound halves|Full Range|Median
1396775|NCT01294241|Primary|Intra-individual Difference in Reepithelialization of Wound (Halves) at Day 14 in ‘Recent Wounds’ or Day 28 in ‘Chronic Wounds’|The primary end point was the progress of reepithelialization from baseline to either Day 14 (‘recent wounds’) or Day 28 (‘chronic wounds’) of the EB wound (half) treated with Oleogel-S10 and non-adhesive wound dressing (Mepilex®) intra-individually compared to the other wound (half) covered with non-adhesive wound dressing only (intra-individual comparison). Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28. They evaluated each series and decided whether 1 wound (half) reepithelialized faster than the other (‘winner’), or whether there was no difference in reepithelialization.|14 days for 'recent wounds', 28 days for 'chronic wounds'|12 wounds in 10 participants (intra-individual comparison, 2 cycles of treatment in 2 participants) were evaluated by assessors that were blind to treatment. 'Undecided' wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|||Wounds|Wounds||Count of Units
1396776|NCT01294228|Primary|The Efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an Aid in the Diagnosis of Acute Kidney Injury (AKI) in an All-comers ICU Setting.|The efficacy of the Triage Neutraphil-Gelatinase Associated Lipocalin (NGAL) Test as an aid in the diagnosis of acute kidney injury (AKI) in an all-comers ICU setting. Final AKI diagnoses were established by an adjudication committee.|Prior to or within 72 hours.|Study participants who had both an adjudicated AKI diagnosis and an evaluable T=0 (study enrollment) blood collection and associated test results.|||Probability||95% Confidence Interval|Number
1396777|NCT01294163|Primary|Log-transformed Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The non-inferiority comparison between Xenon and Sevoflurane was repeated using log-transformed blood troponin levels on the PP Set.|||ng/mL||95% Confidence Interval|Least Squares Mean
1396778|NCT01294163|Secondary|Presence of Absence of Adverse Events, Including Myocardial Infarction||7 days|||||||
1396779|NCT01294163|Secondary|Vital Signs||7 days|||||||
1396780|NCT01294163|Secondary|ECG Abnormalities||7 days|||||||
1396781|NCT01294163|Secondary|Clinical Laboratory Tests||7 days|||||||
1396782|NCT01294163|Secondary|Presence or Absence of Postoperative Delirium|Confusion Assessment Method|7 days|||||||
1396783|NCT01294163|Secondary|Haemodynamic Profile|Monitoring of heart rate, arterial blood pressure, central venous pressure.|4 hours|||||||
1396784|NCT01294163|Secondary|Arterial Oxygen Saturation|Arterial blood gases|4 hours|||||||
1396785|NCT01294163|Secondary|Depth of Anaesthesia|On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)|4 hours|||||||
1396786|NCT01294163|Primary|Blood Level of Troponin I|Blood level of troponin I measured by a central laboratory|Sampling performed 24 hours after the end of the surgical procedure|The primary analysis was a non-inferiority comparison between Xenon and Sevoflurane and was performed on the Per Protocol (PP) Set composed of all randomised and treated patients with no major protocol deviations during the study.|||ng/mL||95% Confidence Interval|Least Squares Mean
1396787|NCT01294150|Secondary|Sexual Function|Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months.|12 Months||||% of Subjects|||Number
1396788|NCT01294150|Primary|Mean UroLift Improvement in IPSS at 12 Months|The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.|12 months||||% IPSS Score Improvement||97.5% Confidence Interval|Number
1396789|NCT01294150|Primary|Comparison of IPSS for Efficacy|"The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone.~The IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH).~SCORING:~0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|3 month||||IPSS total score||Standard Deviation|Mean
1396790|NCT01294150|Primary|Collection of Post-treatment Catheterization for Safety|The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.|Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days||||participants|||Number
1396791|NCT01294098|Secondary|Femur Fracture Healing|we will following patients to look at fracture healing post-operatively|first year||||weeks|||Number
1396792|NCT01294098|Primary|Post-operative Narcotic Use|We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use|within first 24 horus||||mg|||Number
1396793|NCT01294098|Primary|Post-operative Pain Scores|"We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores.~Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain.~0: No Hurt~Hurts a little bit~Hurts a little more~Hurts even more~Hurts a whole lot~Hurts worst"|with in the first 24 hours||||units on a scale||Full Range|Mean
1396794|NCT01294046|Secondary|Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia|Presence or absence of nausea, vomiting, photophobia, and phonophobia will be assessed at baseline and after stimulation at 2 hours for each stimulation for each individual.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396795|NCT01294046|Secondary|Implantation and Stimulation Related Adverse Events|As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396796|NCT01294046|Secondary|Average Per Subject Reduction in Migraine Days/Month|During the baseline period, subjects will record the number of migraine days (as defined by the FDA-approved International Classification of Headache Disorders, 2d Edition definition of migraine with and without aura) during the month. The primary endpoint for this phase is a reduction in the number of migraine days during the last month of the study as compared to the baseline month.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396797|NCT01294046|Secondary|Stimulation Related Adverse Events|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396798|NCT01294046|Secondary|Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline|The Migraine Disability Assessment Scale (MIDAS) is a validated tool that assesses how many days in the last 3 months a patient had at least 50% disability at work, home, school, or recreational activities due to migraine. MIDAS will be assessed at baseline and after study conclusion.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396799|NCT01294046|Secondary|Headache Impact Test (HIT-6) Compared With Baseline|The Headache Impact Test -6 (HIT-6) is a validated tool for evaluating headache impact and disability across 6 domains, which will be recorded at baseline and at study conclusion.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396800|NCT01294046|Secondary|Acute Migraine Medication Use|During the baseline period, subjects will record their acute as-needed migraine relief medication use for each attack by drug, dose, route, and frequency. A secondary endpoint for this phase is a reduction in acute migraine medication usage for each attack for drug, dose, route, and frequency during the last month of the study as compared to the baseline month.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396801|NCT01294046|Secondary|Pain Free at 2 Hours Post Stimulation|As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.|8.5 months|No data were collected from this entire study, so no data were analyzed.||||||
1396802|NCT01294046|Secondary|Migraine Free at 2 Hours|Each migraine will be categorized as meeting the endpoint of migraine free if there is a reduction in the migraine grade to 0 for pain with no nausea, photophobia and phonophobia at 2 hours after initiation of stimulation.|8.5 Months|No data were collected from this entire study, so no data were analyzed.||||||
1396820|NCT01293539|Primary|Number of Patients Who Complete Therapy Without the Need for Additional Treatment Including Systemic Chemotherapy, External Beam Radiation, or Enucleation.|The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.|Within the first six months after the initial treatment.||||Participants|||Count of Participants
1396803|NCT01294046|Primary|Migraine Relief at 2 Hours Post Stimulation|Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.|8.5 Months|No data were collected from this entire study, so no data were analyzed.||||||
1396804|NCT01293968|Secondary|The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed|4 days after the solution consumption|||||||
1396805|NCT01293968|Primary|Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation|pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution|four days after the start of the study|The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS|||scores in Visual Analogue Scale||95% Confidence Interval|Mean
1396806|NCT01293825|Secondary|Quality of Life Score as Measured by 12-item Short Form Health Survey|Scale Range: 1-99th percentile score. Higher scores indicate better outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
1396807|NCT01293825|Secondary|Body Weight||Week 16||||lbs||Standard Deviation|Mean
1396808|NCT01293825|Secondary|Young Mania Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
1396809|NCT01293825|Secondary|Montgomery Asberg Depression Rating Scale|Scale Range: 0-60. Lower scores indicate better outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
1396810|NCT01293825|Secondary|Social and Occupational Functioning Scale|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
1396811|NCT01293825|Secondary|Global Psychopathology Score as Measured by Clinical Global Impressions|Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976). Lower scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
1396812|NCT01293825|Secondary|Attitude Toward Medication Score as Measured by the Drug Attitude Inventory|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
1396813|NCT01293825|Secondary|Treatment Adherence Score as Measured by the Morisky Rating Scale|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Week 16||||units on a scale||Standard Deviation|Mean
1396814|NCT01293825|Primary|Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)|Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.|Week 16||||Percentage of doses||Standard Deviation|Mean
1396815|NCT01293695|Primary|Hot Flash Related Daily Interference Scale (HFRDIS)|This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.|6 Weeks and 12 Weeks||||units on a scale||Standard Deviation|Mean
1396816|NCT01293695|Secondary|Pittsburg Sleep Quality Index (PSQI)|The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rate their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score is determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.|6 Weeks and 12 Weeks||||units on a scale||Standard Deviation|Mean
1396817|NCT01293695|Secondary|Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture|As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.|6 Weeks and 12 Weeks|Analysis was conducted on all available physiological data to determine hot flash frequency. Data was missing for 29 participants in the hypnosis group and 17 participants in the structured attention group.|||Micro Siemens||Standard Deviation|Mean
1396818|NCT01293695|Primary|Hot Flash Score|"Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).~Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).~The values presented represent the average of daily hot flash scores."|6 Weeks and 12 Weeks||||units on a scale||Standard Deviation|Mean
1396819|NCT01293695|Primary|Hot Flash Frequency|The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).|6 Weeks and 12 Weeks||||hot flashes per week||Standard Deviation|Mean
1396871|NCT01292629|Secondary|Complications and Adverse Events|Number of Participants with Complications or Adverse Events|4 to 6 months||||participants|||Number
1396821|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||logMAR|Participants|Standard Deviation|Mean
1396822|NCT01293240|Primary|Corrected Visual Acuity|Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||logMAR|Participants|Standard Deviation|Mean
1396823|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer’s eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale|Participants|Standard Deviation|Mean
1396824|NCT01293240|Primary|Lens Deposits|Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer’s eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale|Participants|Standard Deviation|Mean
1396825|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396826|NCT01293240|Primary|Visual Clarity|Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396827|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396828|NCT01293240|Primary|Ocular Redness|Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396829|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396830|NCT01293240|Primary|End of Day Dryness|End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396831|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396832|NCT01293240|Primary|Overall Comfort|Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|2 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1396833|NCT01293084|Secondary|Percent Mucociliary Clearance at 90 Minutes||90 minutes|Data for participants that completed and received both 7% saline and 0.12% saline.|||percentage mucociliary clearance||Inter-Quartile Range|Median
1396834|NCT01293084|Primary|Percent Mucociliary Clearance at 60 Minutes||60 minutes|Participants that completed received both 7% saline and 0.12% saline over the duration of the study|||percentage mucociliary clearance||Inter-Quartile Range|Median
1396872|NCT01292629|Primary|Visual Acuity|BEST Spectacle-Correction (ETDRS) Distance Visual Acuity|4 to 6 months|125 subjects enrolled in the study, 121 were examined at the Form 4 and the remaining four (3.2%) subjects missed the Form 4 visit but were examined later. 121 subjects were evaluated for primary and secondary effectiveness and safety outcomes.|||subjects|||Number
1396835|NCT01293032|Primary|The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment|The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.|Up to 2 years|Patients with an intermediate RS(11-25) assigned to Group 2, Arm 1, and Arm 2 were combined in the analysis.|||proportion of participants||95% Confidence Interval|Number
1396836|NCT01293006|Secondary|Mean Arterial SaO2 During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant on mean oxygen saturation (SaO2) during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 1 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
1396837|NCT01293006|Secondary|Mean Arterial SaO2 for Different Sleep Stages|Comparison of the mean SaO2 during different sleep stages (REM, Non-REM, and awake) following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment. Sleep stages were determined by polysomnography.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
1396838|NCT01293006|Secondary|Mean Apnea/Hypopnea Index (AHI)|Evaluation of the effect of multiple dose administration of suvorexant on AHI as measured by polysomnography. The AHI is an overall index of obstructive sleep apnea (OSA) severity. The AHI is calculated by dividing the number of apneas and hypopneas by the number of hours of sleep. AHI values are categorized as mild OSA = 5 to <15/hr and moderate OSA = 15 to <30/hr.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Events per hour||95% Confidence Interval|Least Squares Mean
1396839|NCT01293006|Secondary|Percentage of Total Sleep Time in Which SaO2 is Less Than 90%, 85% or 80%|Evaluation of the percentage of the night in which SaO2 is less than 90%, less than 85% and less than 80% following multiple dose administration of suvorexant and placebo. Lower SaO2 values are associated with sleep impairment.|Day 1 and Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Percentage of Total Sleep Time||95% Confidence Interval|Least Squares Mean
1396840|NCT01293006|Primary|Number of Participants Discontinued From Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 15 days|All participants were included in the Safety Population.|||participants|||Number
1396841|NCT01293006|Primary|Number of Participants With Adverse Events|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 14 days after last dose|All participants were included in the Safety Population.|||participants|||Number
1396842|NCT01293006|Primary|Mean Arterial Oxygen Saturation (SaO2) During Total Sleep Time|Evaluation of the effect of multiple dose suvorexant (MK-4305) on SaO2 during total sleep time as measured by pulse oximetry. Lower SaO2 values are associated with sleep impairment. Total sleep time is the total of all rapid eye movement (REM) and non-REM sleep in a sleep episode.|Day 4 of each period|Twenty-four of the 25 participants were included in the primary evaluation of SaO2 and AHI data; one participant was excluded due to a protocol violation. During the Placebo periods, there were 22 evaluable participants at Day 4; 2 participants had either no data or missing data.|||Percentage of Oxygen Saturation||95% Confidence Interval|Least Squares Mean
1396843|NCT01292928|Other Pre-specified|Quality of Life|Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Quality of Life Analysis were available for 265 subjects|||units on a scale||Standard Deviation|Mean
1396844|NCT01292928|Other Pre-specified|Walking Improvement (Distance) Assessed by 6 Minute Hall Walk|Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects|||meters||Standard Deviation|Mean
1396845|NCT01292928|Other Pre-specified|Walking Improvement (Time) Assessed by 6 Minute Hall Walk|Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement Assessed by 6 minute Hall Walk Analysis were available for 246 subjects|||minutes||Standard Deviation|Mean
1396934|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
1396846|NCT01292928|Other Pre-specified|Walking Improvement Assessed by the Walking Impairment Questionnaire|The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Walking Improvement assessed by the Walking Impairment Questionnaire were available for 265 subjects|||units on a scale||Standard Deviation|Mean
1396847|NCT01292928|Other Pre-specified|Rate of Hemodynamic Improvement|"The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.~Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR.~Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR."|12 months|278 subjects were included in the Rate of Hemodynamic Improvement Analysis (275 subjects eligible for the 12-Month Follow-Up + 3 subjects with TLR)|||percentage of limbs|limbs||Number
1396848|NCT01292928|Other Pre-specified|Rutherford Classification|"Class 0: Asymptomatic~Class 1: Mild claudication~Class 2: Moderate claudication~Class 3: Severe claudication~Class 4: Ischemic rest pain~Class 5: Minor tissue loss – nonhealing ulcer, focal gangrene with diffuse pedal edema~Class 6: Major tissue loss – extending above metatarsal (MT) level~Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR.~Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR.~Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure"|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Rutherford Classification Analysis was available for 263 subjects|||percentage of participants|||Number
1396849|NCT01292928|Other Pre-specified|Stent Fracture Rate|"Vascular InterVentional Advances (VIVA) definitions:~Grade 0: No strut fractures~Grade I: single strut fracture~Grade II: multiple strut fractures~Grade III: stent fracture(s) with preserved alignment of the components~Grade IV: stent fracture(s) with mal-alignment of the components~Grade V: stent fracture(s) in a trans-axial spiral configuration"|12 months|From the 276 subjects that were eligible for the 12-Month Follow-Up, data for the Stent Fracture Analysis were available for 250 subjects|||percentage of stents|stents||Number
1396850|NCT01292928|Other Pre-specified|Assisted Primary Patency|Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Assisted Primary Patency Analysis was available for 256 subjects|||percentage of lesions||95% Confidence Interval|Number
1396851|NCT01292928|Other Pre-specified|Primary Patency|Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Patency Analysis was available for 268 subjects/lesions|||percentage of lesions|Lesions|95% Confidence Interval|Number
1396852|NCT01292928|Other Pre-specified|Technical and Procedural Success|"Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%~Procedural success: technical success with no MAEs within 24 hours of the procedure"|Up to 24 hours after the procedure||||percentage of participants||95% Confidence Interval|Number
1396853|NCT01292928|Secondary|Secondary Safety Endpoint and Components|The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month|1 month|From the 299 enrolled subjects, data for the Secondary Safety Endpoint was available for 297 subjects|||percentage of participants||95% Confidence Interval|Number
1396854|NCT01292928|Primary|Co-Primary Efficacy Endpoints|"The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure.~The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm).~The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm)."|12 months|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Co-Primary Efficacy Endpoints were available for 268 subjects|||percentage of participants||95% Confidence Interval|Number
1396855|NCT01292928|Primary|Primary Safety Endpoint and Components|The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months|1 month for death, 12 months for target limb major amputation , and target lesion revascularization|From the 275 subjects that were eligible for the 12-Month Follow-Up, data for the Primary Safety Endpoint were available for 268 subjects.|||percentage of participants||95% Confidence Interval|Number
1396856|NCT01292876|Secondary|Percentage of Participants With Remodeling Response Approximately 6 Months Post-operative|The secondary objective is to examine the cellular properties of the biopsy tissue material in each subject for future correlation with clinical outcomes. Seven biopsy samples were collected and stained with Hematoxylin and eosin (H&E) and Masson’s trichrome stain. Tissue was stained with antibodies against the progenitor cell markers CD146 and NG2 to show evidence of progenitor cell migration into the remodeling injury site.|Approximately 6 months post-operative|Demonstrated remodeling response; discrepancy from from those completed in the study (12 of 13) is result of 1 subject not undergoing pathological examination.|||percentage of participants remodeling|||Number
1396857|NCT01292876|Primary|Percent Change From Baseline in the Rectified and Integrated EMG Signal of the Tibialis Anterior Muscle At 24 Weeks Post-Operative|The physical therapy program was designed to promote activation of the dorsiflexor muscles on the operated side, through manual feedback during volitional contractions.|approximately 24 weeks post-operative||||% change||95% Confidence Interval|Mean
1399648|NCT01265550|Secondary|Number of Successful Participants With Belching Disorders|Presence of belching disorders as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1396858|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.|Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period."|||participants|||Number
1396859|NCT01292837|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Treatment Period|A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.|Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.|||participants|||Number
1396860|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period|The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|"The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period."|||percentage of participants|||Number
1396861|NCT01292837|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.|||percentage of participants|||Number
1396862|NCT01292837|Secondary|The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period|"The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - E)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with combined Baseline Period and post-Baseline generalized tonic-clonic seizure counts. 12 of the 13 subjects in the FAS were included in the analysis excluding 1 subject discontinued before the Evaluation Period.|||percent change||Standard Deviation|Mean
1396863|NCT01292837|Primary|The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)|"The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below.~The percent change from Baseline = (B - T)/B x 100~The seizure frequency per week was calculated using the following formula:~Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7"|From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.|||percent change||Standard Deviation|Mean
1396864|NCT01292798|Secondary|Qualitative Assessment of Diabetic Macular Edema (DME)|To compare the percentage of subjects with compete or partial/no resolution of diabetic macular edema in response to the ranibizumab 0.5 and 2.0 mg doses.|Baeline and 6 months|At 6 months, 18 out of the 43 subjects (42%) showed complete resolution of DME. 25 out of the 43 subjects (58%) showed partial or no resolution of DME at 6 months.|||percentage of participants|||Number
1396865|NCT01292798|Secondary|Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline|To determine the mean change in central 1-mm subfield thickness as measured by spectral-domain OCT from baseline to 6 months .|baseline and 6 months||||microns||Standard Deviation|Mean
1396866|NCT01292798|Primary|Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline|To determine the mean change in the best-corrected visual acuity on an ETDRS visual acuity chart at a starting distance of 4 meters from baseline to 6 months.|baseline and 6 months||||letters||Standard Deviation|Mean
1396867|NCT01292746|Primary|Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area|Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.|Baseline and 13 Weeks||||hairs/cm2||Standard Deviation|Mean
1396868|NCT01292642|Secondary|Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks|The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction.|10 weeks||||Scores on a scale||Standard Deviation|Mean
1396869|NCT01292642|Primary|Cannabis Use|cannabis inhalations per day|Baseline and 10 weeks||||cannabis inhalations/day||Standard Deviation|Mean
1396870|NCT01292642|Primary|Cigarette Use|cigarettes per day|Baseline and 10 weeks||||cigarettes/day||Standard Deviation|Mean
1396873|NCT01292603|Secondary|Part 2: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n= number of participants analyzed at the specified visit.|||percentage of participants|||Number
1396874|NCT01292603|Secondary|Part 2: Total CD19+ B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit|Part 2 SAP; n = number of participants analyzed at the specified visit.|||cells/μL||Full Range|Median
1396875|NCT01292603|Secondary|Part 1: Percentage of Participants With Total B-Cell Depletion by Visit|Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.|Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.|||percentage of participants|||Number
1396876|NCT01292603|Secondary|Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit|CD 19 is a surface antigen (protein) present on B-lymphocytes.|Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24|Part 1 SAP; n = number of participants analyzed at the specified visit.|||cells per microliter (cells/μL)||Full Range|Median
1396877|NCT01292603|Secondary|Part 2: Percentage of Participants With Anti-Rituximab Antibodies|In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.|Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.|SAP; n = number of participants analyzed for the specific parameter.|||percentage of participants|||Number
1396878|NCT01292603|Secondary|Part 1: Percentage of Participants With Anti-Rituximab Antibodies|Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.|Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose|Safety Analysis Population (SAP): all participants who received at least one dose of study medication, whether prematurely withdrawn from the study or not. This included 8 participants that did not receive SC rituximab. n = number of participants analyzed.|||percentage of participants|||Number
1396879|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question: Which formulation of rituximab (SC or IV) do you think is more convenient? with pre-specified responses as below. Percentage of participants with specified answers were reported.~A - Rituximab SC is much more convenient.~B - Rituximab SC is a little more convenient.~C - Both formulations are equally convenient.~D - Rituximab IV is a little more convenient.~E - Rituximab IV is much more convenient"|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis. n = number of physicians or nurses that responded to the survey.|||percentage of participants in the survey|||Number
1396880|NCT01292603|Secondary|Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV|"Physicians and nurses who administered rituximab were asked to answer the following question:  If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones). Percentage of participants with specified answers were reported.~A- Less than 1 hour~B- At least 1 hour but less than 2 hours~C- At least 2 hours but less than 3 hours~D- At least 3 hours but less than 4 hours~E- 4 or more hours"|Days 4-5 in Cycle 6|All the physicians and nurses who responded to the questionnaire were included in the analysis. number (n) = number of physicians or nurses that responded to the survey.|||percentage of participants in the survey|||Number
1396881|NCT01292603|Secondary|Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration|In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC|Days 4 to 5 in Cycle 6|All participants in Part 1 were included in this analysis including 8 participants that did not receive SC rituximab.|||percentage of participants or nurses|||Number
1396882|NCT01292603|Secondary|Part 2: Terminal Half-Life of Rituximab at Cycle 6|The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
1396883|NCT01292603|Secondary|Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6|Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
1396884|NCT01292603|Secondary|Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6|Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1396885|NCT01292603|Secondary|Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6|"AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below:~Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)– ln(AUC IV)."|Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6|Only participants who entered Part 2 of the study and had PK data available were included in the analysis.|||μg*day/mL||Geometric Coefficient of Variation|Geometric Mean
1396886|NCT01292603|Primary|Part 2: Rituximab C Trough Levels at Cycle 5|Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.|+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration|Only participants who entered Part 2 of the study and had pharmacokinetic (PK) data available were included in the analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1396887|NCT01292603|Primary|Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab|Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.|Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose|Enrolled (non-randomized) Pharmacokinetic Evaluable Population (Part 1) included all participants from Part 1 who did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or have unavailable or incomplete data which could influence the pharmacokinetic analysis.|||mg|||Number
1396888|NCT01292538|Secondary|Body Weight (Pounds)||2 weeks|||||||
1396889|NCT01292538|Secondary|Subject Self-reported Satisfaction With Study Outcome||2 weeks|||||||
1396890|NCT01292538|Secondary|Body Mass Index (BMI)||2 weeks|||||||
1396891|NCT01292538|Primary|Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs|Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.|2 weeks||||inches||Standard Deviation|Mean
1396892|NCT01292486|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product White Blood Cells (WBC) that were segmented granulocytes or bands.|7 days|Data to calculate the percent of product WBCs that were segmented granulocytes or bands was available for 38 MNC collections on 25 of the 26 per protocol patients.|||percentage of product WBCs|Participants|Full Range|Median
1396893|NCT01292486|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.|7 days|Data was available from 38 MNC collections from 25 of the 26 per protocol patients.|||hematocrit %|Participants|Full Range|Median
1396894|NCT01292486|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|up to 7 days|Data to calculate platelet collection efficiency was available for 38 MNC collections on 24 of the 26 per protocol patients.|||% of processed platelets collected|Participants|Full Range|Median
1396895|NCT01292486|Secondary|Mononuclear Cel (MNC) Collection Efficiency|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.~Determination of collection efficiency depends on an estimate of the average concentration of target cells in the patient's blood. Because these cells are continuously being removed during the collection, and are undergoing variable replacement from the bone marrow, this estimate will not be completely accurate. Underestimation of the concentration of target cells processed can lead to collection efficiencies of greater than 100%."|up to 7 days|Data was available to calculate MNC collection efficiency on 35 collections performed on 22 of the 26 per protocol patients.|||% of processed MNCs that were collected|Participants|Full Range|Median
1396896|NCT01292486|Secondary|CD34+ Cell Collection Efficiency.|"Collection efficiency (CE) is defined as the percentage of any given cellular subset, processed by the system, that is collected from the subject.~CD34+ is a cell surface marker found on pluripotent hematopoeitic stem cells."|up to 7 days|Data to calculate CD34+ cell collection efficiency was available for 39 collections on 24 of 26 per protocol patients.|||% of processed CD34+ cells collected|Participants|Full Range|Median
1396897|NCT01292486|Secondary|Days Until Platelet Recovery|The time to platelet recovery is defined as the day following stem-cell transplant (Day 0) on which the platelet count exceeds 20,000/μL, for the first of three consecutive measurements obtained on different days, without platelet transfusion support within the preceding 7 days.|up to 28 days following transplant|All per protocol patients for whom platelet recovery data was available.|||days||Full Range|Median
1396906|NCT01292473|Secondary|Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
1396898|NCT01292486|Primary|Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.|"Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease.~As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D > |2|, where D = Observed median day of neutrophil recovery – Site specific historic median day of neutrophil recovery."|up to 28 days following transplant|Twenty-six patients were evaluable per protocol.|||Days||Full Range|Median
1396899|NCT01292473|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.|||Percentage of days||Standard Deviation|Mean
1396900|NCT01292473|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12|The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug and who had a DLQI score at Week 12.|||Units on a scale||Standard Deviation|Mean
1396901|NCT01292473|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
1396902|NCT01292473|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.~The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline."|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Percentage of participants|||Number
1396903|NCT01292473|Secondary|Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12|The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement.|Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Percentage of participants|||Number
1396904|NCT01292473|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|"The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.~The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved."|by Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Weeks||95% Confidence Interval|Median
1396905|NCT01292473|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
1396932|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
1396907|NCT01292473|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline, Week 12|Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.|||Units on a scale||Standard Deviation|Mean
1396908|NCT01292304|Secondary|Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)|This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.|12 weeks of study drug||||Days||Full Range|Median
1396909|NCT01292304|Primary|Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)|This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)|12 weeks of study drug||||participants|||Number
1396910|NCT01292304|Secondary|Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)|Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L|12 weeks||||participants|||Number
1396911|NCT01292304|Secondary|Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)|Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing|12 weeks||||participants|||Number
1396912|NCT01292304|Primary|Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)|Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing|Week 12||||participants|||Number
1396913|NCT01292265|Secondary|Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
1396914|NCT01292265|Secondary|Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
1396915|NCT01292265|Secondary|Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
1396916|NCT01292265|Primary|Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12||From Baseline (Week 0) to Week 12|Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.||||||
1396917|NCT01292239|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for all participants in the TMC435 treatment group who received TMC435 for up to 12 weeks. The time frame of “Overall” (up to Week 12) represents the median exposure estimate using all available data for each participant in the study.|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng.h/mL||Full Range|Median
1396918|NCT01292239|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) maximum plasma concentration (Cmax) values for TMC435 for all participants in the TMC435 treatment group. The time frame of “Overall” (up to Week 12) represents the median exposure estimate using all available data for each participant in the study.|Overall (ie, Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
1396919|NCT01292239|Secondary|The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in the TMC435 treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with pegIFN alpha 2a and RBV at Week 24. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group continued treatment with PegIFN alpha 2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1396920|NCT01292239|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline (Day 1) who achieved normal ALT levels at the EOT (up to Week 24 or 48). At Baseline, 61/123 participants in the TMC435 treatment group and 25/60 participants in the Placebo treatment group had abnormal ALT levels. At the EOT, 47 (77.0%) participants in the TMC435 treatment group and 18 (72.0%) participants in the Placebo treatment group had ALT levels that returned to normal (or normalization of ALT levels defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT.).|Baseline (Day 1) to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1396933|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
1396921|NCT01292239|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) at the End of Treatment (EOT) (up to Week 24 or 48) and detectable HCV RNA during follow-up or detectable plasma levels of HCV RNA at the time points of sustained virologic response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable plasma levels of HCV RNA at the EOT and with at least one follow-up HCV RNA. measurement.|Up to Week 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1396922|NCT01292239|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of > 1 log10 IU/mL in plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA)l from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period (up to the end of treatment [EOT]).|Up to EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1396923|NCT01292239|Secondary|The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable plasma levels of HCV RNA <1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at the EOT (up to Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1396924|NCT01292239|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in plasma levels of HCV RNA at each time point during treatment and post-treatment follow-up (FU).|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60, 72, EOT (up to Week 24 or 48), FU Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1396925|NCT01292239|Secondary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT, defined as up to Week 24 or 48) and at 24 weeks after the last dose of treatment (up to Week 48 or 72).|EOT (up to Week 24 or 48) and 24 weeks after the after the last dose of treatment (up to Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1396926|NCT01292239|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1396927|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples|||correlation coefficient|Participants||Number
1396928|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples|||correlation coefficient|Participants||Number
1396929|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples|||correlation coefficient|Participants||Number
1396930|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population|||correlation coefficient|Participants||Number
1396931|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population|||correlation coefficient|Participants||Number
1396935|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
1396936|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
1396937|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed|||correlation coefficient|Participants||Number
1396938|NCT01292226|Secondary|Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity|The Spearman's rank correlation coefficient was computed by ranking the data from 2 time points, 0 minutes and 120 minutes, and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|BL and Weeks 2, 4, 12, and 24|ITT population; n=number of samples analyzed.|||correlation coefficient|Participants||Number
1396939|NCT01292226|Secondary|Percentage of Participants With Hematologic Toxicity|Hematological toxicities graded according to WHO worst grade observed (Grade 1=mild, Grade 2=moderate).|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population|||percentage of participants|||Number
1396940|NCT01292226|Secondary|Percentage of Participants With Gastrointestinal Toxicities|Gastrointestinal adverse events (AEs) according to WHO worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)|Safety population|||percentage of participants|||Number
1396941|NCT01292226|Secondary|Percentage of Participants With Infection|Infections were graded according to the World Health Organization (WHO) worst grade observed.|BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)|Safety population: all enrolled participants|||percentage of participants|||Number
1396942|NCT01292226|Secondary|Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint|TNF gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
1396943|NCT01292226|Secondary|Interleukin 8 (IL-8) Expression by Visit and Timepoint|IL-8 gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
1396944|NCT01292226|Secondary|IMPDH Expression II by Visit and Timepoint|IMPDH II gene expression was measured by QRT-PCR based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of mRNA copies/cell.|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
1396945|NCT01292226|Secondary|IMPDH Expression I by Visit and Timepoint|IMPDH I gene expression was measured by real time polymerase chain reaction (QRT-PCR) based cytokine measurement of PBMCs at 2 timepoints per visit, 0 and 120 minutes and expressed as number of messenger ribonucleic acid (mRNA) copies per cell (copies/cell).|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||number of mRNA copies/cell|Participants|Standard Deviation|Mean
1396946|NCT01292226|Secondary|Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint|"IMPDH activity in peripheral blood mononuclear cells (PBMCs) was measured at 2 timepoints per visit, 0 and 120 minutes and presented in enzyme units. The unit of measure of enzyme activity is U. One U is defined as the amount of the enzyme that produces a certain amount of enzymatic activity that is, the amount that catalyzes the conversion of 1 micro mole of substrate per minute under pre-specified conditions (temperature, pH)."|BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits|ITT population; n=number of samples analyzed.|||enzyme units|Participants|Standard Deviation|Mean
1396947|NCT01292226|Secondary|MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit|The AUC0-12 of MPA was estimated on the validated limited sampling strategy, AUC (milligrams multiplied by height over liter [mg.h/L]) = 7.182 + 4.607 multiplied by (*) concentration at 0 minutes (C0)+ 0.998 * the concentration at 40 minutes (C0.67) + 2.149 * the concentration at 120 minutes (C2).|Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mcg*hr/mL||Standard Deviation|Mean
1396948|NCT01292226|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)|BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (>)25% of parenchyma affected, and foci of moderate tubulitis with >4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with >25% parenchyma affected, and foci of severe tubulitis with >10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising >25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.|Day 1, Weeks 2, 4, 12, 24, and 28|ITT population|||percentage of participants|||Number
1396949|NCT01292226|Secondary|Free MPA (mcg/mL) by Visit|Drug quantification of free MPA in the plasma was measured at T = 0, 40, and 120 mins.|Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits|ITT population; n=number of samples analyzed.|||mcg/mL|Participants|Standard Deviation|Mean
1396954|NCT01292226|Primary|Percentage of Participants With Acute Rejection|Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.|Day 1, Weeks 2, 4, 12, 24, and 28|Intent-to-treat (ITT) population: all eligible participants who had at least baseline (BL) and 1 assessment of pharmacokinetics (PK) and pharmacodynamics (PD). Acute rejection was analyzed in any participant with an increase in serum creatinine of 25%.|||percentage of participants|||Number
1396955|NCT01292187|Secondary|Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.||Baseline, Week 54|MITT population|||percent change||95% Confidence Interval|Least Squares Mean
1396956|NCT01292187|Primary|Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.||Baseline, Week 54|MITT population|||percent change||95% Confidence Interval|Least Squares Mean
1396957|NCT01292135|Secondary|Progression Free Survival Rate at 12 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.||||Percentage of Participants||95% Confidence Interval|Number
1396958|NCT01292135|Secondary|Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline||From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.|No participants in the FCR group had neutropenia, anemia or thrombocytopenia at baseline.|||Percentage of Participants||95% Confidence Interval|Number
1396959|NCT01292135|Secondary|Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.|From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants||95% Confidence Interval|Number
1396960|NCT01292135|Secondary|Overall Incidence of Serious Adverse Events (SAEs)||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants|||Number
1396961|NCT01292135|Secondary|Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants|||Number
1396962|NCT01292135|Secondary|Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.||||Percentage of Participants|||Number
1396963|NCT01292135|Primary|Incidence of Prolonged Hematologic Toxicity Started in Cycle 1||From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.|The FCR arm was discontinued due to very limited use of this chemo regimen in this setting, statistical analysis were limited due to the small numbers of subjects in this treatment arm.|||Percentage of Participants||95% Confidence Interval|Number
1396964|NCT01292070|Primary|Difference in the Doses of GFD and CAT Required to Elicit a Cutaneous Reaction Demonstrated by a Wheal Greater Than or Equal to 10 mm With Surrounding Erythema|Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.|up to 3 hours after the last injection of GFD|The experimental protein (human Fcgamma1-Fel d1 fusion protein (GFD)) and the control protein (standardized cat hair allergenic extract (CAT)) elicited comparable reactivity in the first four participants dosed; thus, the trial was discontinued for futility and the primary endpoint was not evaluated||||||
1396965|NCT01292057|Primary|Total Number of Drinks Consumed in Bar Lab|"This measure refers to a bar lab paradigm in which individuals received an initial priming drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8."|2 hours during the bar lab paradigm||||bar lab drinks||Standard Error|Mean
1396966|NCT01292057|Primary|Total Number of Drinks Per Day During Natural (Usual Environment) Conditions|"Natural alcohol consumption period -- drinks per day consumed during the 6-day observation period"|6-day observation period||||standard drinks||Standard Error|Mean
1396967|NCT01292005|Secondary|Number of Subjects Who Needed an Intensive Care Unit Stay||30 days, or until dismissal, whichever came first||||participants|||Number
1396968|NCT01292005|Secondary|Length of Intensive Care Unit (ICU) Stay||30 days or until dismissal date, whichever occurs earlier||||Days||Full Range|Median
1396969|NCT01292005|Secondary|Length of Hospital Stay||30 days or until dismissal date, whichever occurs earlier||||days||Full Range|Median
1396970|NCT01292005|Secondary|Number of Patients With Lengthy Hospital Stays|"Lengthy was defined as either greater than 4 days or greater than 10 days."|30 days or until dismissal date, whichever occurs earlier||||participants|||Number
1396971|NCT01292005|Secondary|Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization||1 week or until dismissal date whichever occurs earlier||||participants|||Number
1396972|NCT01292005|Secondary|Number Of Subjects With New Onset Organ Failure During Hospitalization||1 week or until dismissal date whichever occurs earlier.||||participants|||Number
1396973|NCT01292005|Primary|Changes in Interleukin (IL) IL-8|Normal value range for IL-8 = 0 - 5 pg/ml.|baseline, Day 1, Day 3||||pg/ml||Full Range|Median
1396974|NCT01292005|Primary|Change in Interleukin (IL) IL-6|Normal value range for IL-6 = 0 - 5 pg/ml.|baseline, Day 1, Day 3||||pg/ml||Full Range|Median
1396975|NCT01292005|Primary|Change in Tumor Necrosis Factor (TNF)-Alpha|Normal value range for TNF alpha = 0 - 22 pg/ml.|baseline, Day 1, Day 3||||pg/ml||Full Range|Median
1396977|NCT01291836|Primary|Evaluating the Efficacy of the Triage NGAL Test as an Aid in Predicting Poorer Outcomes in Patients Admitted to the Hospital With Admitted With Symptoms of Acute Heart Failure.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|~30 days|Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.|||Probability classifying AKI from non-AKI||95% Confidence Interval|Number
1396978|NCT01291836|Primary|Evaluating the Efficacy of the Triage NGAL Test as an Aid to Diagnosis of Acute Kidney Injury (AKI) in Patients Admitted to the Hospital With Symptoms of Acute Heart Failure.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|First week of hospitalization.|Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol.|||Probability classifying AKI from non-AKI||95% Confidence Interval|Number
1396979|NCT01291784|Secondary|JAK2V617F Allele Burden|Investigate exploratory markers, hematopoietic cells, for their ability to predict responsiveness to treatment with GC1008. Analysis of percentage of mutant alleles in hematopoietic stem cells.|6 months||||percentage of mutant alleles|||Number
1396980|NCT01291784|Secondary|Peripheral Blood CD34+|Investigate exploratory markers for their ability to predict responsiveness to treatment with GC1008.|6 months||||percentage of hematopoietic stem cells|||Number
1396981|NCT01291784|Secondary|European Consensus Fibrosis Grade|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by European consensus grading system.~This scheme consists of a qualitative (reticulin or collagen) and quantitative evaluation of bone marrow fibrosis and distinguishes four increasing categories, ranging from MF-0, which corresponds to normal bone marrow, to MF-3, in which coarse bundles of collagen fibrosis are identifiable with significant osteosclerosis."|6 months||||units on a scale|||Number
1396982|NCT01291784|Secondary|Bauermeister Scale|"To assess the clinical response to therapy with GC1008 by International Working Group (IWG) criteria and measure the change in degree of bone marrow fibrosis (BMF) assessed by Bauermeister scale.~Bauermeister scale: 0, no demonstrable reticulin fibers; 1, occasional fine individual fibers and foci of a fine-fiber network; 2, fine fiber network throughout most of the section, but no coarse fibers; 3, diffuse fiber network with scattered thick coarse fibers, but no mature collagen; and 4, diffuse, often coarse fiber network with areas of collagen."|6 months||||units on a scale|||Number
1396983|NCT01291784|Primary|Safety and Tolerability|"To assess the safety and tolerability of GC1008 in patients with primary myelofibrosis (PMF) or post-polycythemia vera/essential thrombocythemia myelofibrosis (Post-PV/ET MF).~A total of 9 AEs determined by the investigator to be at least possibly related to GC1008 occurred during the study."|28 days||||events|||Number
1396984|NCT01291498|Secondary|Voice Morbidity|Voice Handicap Index. 30 questions rated on a five point scale from 'never' to 'always' and an overall score from 1 'normal' to 10 'severely impaired'|Up to one year post-treatment||||units on a scale|||Number
1396985|NCT01291498|Secondary|Eucalcaemia|Ca in plasma|Six weeks post-treatment.Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.|Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.|||mmol/L|||Number
1396986|NCT01291498|Primary|Eucalcaemia|Calcium in the blood is measured from venepuncture|12 months post-treatment|The primary endpoint was not analysed because only one subject was entered and this subject was withdrawn from the study before 12 months after treatment.||||||
1396987|NCT01291277|Primary|Proportion of Patients With Eradication of Esophageal Varices||At 4 weeks||||Participants|||Count of Participants
1396988|NCT01291264|Primary|Subject's Infected-status as Determined by the Nucleic Acid Amplification Assays Performed.|This is a single-point prevalence assessment done when subjects present at the STD clinic for routine STD screening. Subjects are not followed beyond the clinic visit.|1 day - (At clinic visit)|per protocol|||Positive test result|||Number
1396989|NCT01291225|Secondary|Playground and Farm Safety Knowledge, Attitudes and Practices Composite Scores|The investigators hypothesize that the improvement in the playground safety Knowledge, Attitudes, and Practices (KAP) survey composite scores and farm audits from the baseline in year 1 to the follow-up in year 3 will be significantly greater for parents residing in Ross County than for parents in the non-intervention counties (Morrow and Pickaway).The playground safety KAP survey consisted of 7 items and individuals could receive a summed score of 0-7, with a score of 7 indicating mastery of the material.|Year 1 baseline to Year 3 follow-up||||composite score||Standard Deviation|Mean
1396990|NCT01291225|Primary|Change in Playground Hazards|The investigators hypothesize that the decrease in the number of identified playground hazards (comparing each playground to itself from the year 1 baseline survey to the year 3 follow-up survey utilizing a playground hazards checklist) will be significantly greater for the intervention playgrounds compared with non-intervention playgrounds in Circleville, Pickaway Co. The percentage increase in the number of playgrounds with adequate safety surfacing will be used as a proxy for playground hazardousness.|Year 1 baseline to year 3 follow-up||||% increase playgrounds w/surfacing|||Number
1396991|NCT01291173|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1396992|NCT01291173|Secondary|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11|The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 – 120. Higher scores indicate increased impulsiveness.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1396993|NCT01291173|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 11|The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1396994|NCT01291173|Secondary|Change From Baseline in Eating Inventory Score at Week 11|The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1396995|NCT01291173|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11|The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1396996|NCT01291173|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1396997|NCT01291173|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11|The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1396998|NCT01291173|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)|||Percentage of participants|||Number
1396999|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)|||Percentage of participants|||Number
1397000|NCT01291173|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)|||Percentage of participants|||Number
1397001|NCT01291173|Secondary|4-Week Binge Response|Subjects are free from binge episodes for 4 weeks.|Last 28 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Participants|||Number
1397002|NCT01291173|Secondary|1-Week Binge Response, Last Observation Carried Forward (LOCF)|The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.|Last 7 days on study|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Participants|||Number
1397003|NCT01291173|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks|The number of binge episodes per week as assessed by clinical interview based on subject diary.|Baseline and up to 11 weeks|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Binge Episodes||Standard Deviation|Mean
1397004|NCT01291173|Primary|Change From Baseline in Log Transformed Binge Days Per Week at Week 11|Binge day is defined as a day during which at least 1 binge episode occurs.|Baseline and week 11|Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.|||Log days||Standard Error|Least Squares Mean
1397005|NCT01291160|Primary|Number of 100% Wound Closure||before or at week 12|Analyzed the per-protocol population|||percentage of patients|||Number
1397006|NCT01291108|Secondary|Change From Baseline in Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1397007|NCT01291108|Primary|Change From Baseline in Average Eye IOP|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.|Baseline, Day 57|Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1397008|NCT01291056|Primary|Luteal Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Physical symptoms were calculated to give the total score. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
1397009|NCT01291056|Primary|Luteal Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
1397010|NCT01291056|Primary|Follicular Cycle Total Physical Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify physical symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 Year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
1397011|NCT01291056|Primary|Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment|To identify behavioral symptoms experienced by women taking clomiphene citrate versus placebo for superovulation in a prospective setting.|1 year|The scale incorporates physical, behavioral and mental symptoms. Each participant will rate the symptom(s) from zero to three based off severity. Symptoms with zero means that no symptoms are present. Symptoms with three means that the symptoms are severe. Range 0 -75 per cycle day.|||units on a scale||Full Range|Median
1397012|NCT01291017|Secondary|Grade of Study Drug Toxicity|The number of all toxicities and grades 3 and 4 (per CTCAE v3.0) toxicities that occured during the administration of the drug and during the follow up period.|24 months||||Events|||Number
1397013|NCT01291017|Secondary|Plasma Levels|Plasma levels of p16, phosphorylated RB and cyclin d1 in blood.|6 months|4 of the 16 samples were tested by protein immunoblot (Western blot), and due to the test not being sensitive enough to detect p16, phosphorylated RB or cyclin D1 protein bands in any of the samples, the decision was made not to purse this testing any further.|||Arbitrary Units|||Number
1397014|NCT01291017|Secondary|Progression-free Survival|Median progression-free survival.|12 months||||Weeks||Standard Error|Median
1397015|NCT01291017|Secondary|Overall Survival|Median overall survival|14 months||||weeks||Standard Error|Median
1397016|NCT01291017|Primary|Tumor Response by Direct RECIST Measurement|Response is a decrease in the sum of the longest diameters of the target lesions by more than 30% compared to the baseline.|6 months||||participants|||Number
1397017|NCT01290978|Secondary|Skin Assessment on Ioban, ActiGard, Steri-Drape 2 Application Sites Respectively|Visual assessment on skin after samples were removed. scale: 0 (no skin reaction), 4 (severe skin reaction)|30 minutes|The number of participants was determined to provide 80% power to detect a difference of 20% for the drape by prep comparisons|||units on a scale||Standard Deviation|Mean
1397018|NCT01290978|Primary|Drape Adhesion|The peel force to remove the sample|30 minutes|Data analysis per protocol|||grams-force||95% Confidence Interval|Mean
1397019|NCT01290952|Secondary|Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one of more of the following:~Post-operative Atrial Fibrillation~IAPB (Intra-Aortic Balloon Pump) insertion and low cardiac output syndrome~Ventilation > 24h~Sternal wound infection or dehiscence"|30 days||||participants|||Number
1397020|NCT01290952|Primary|Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)|"Number of patients with one or more of the following:~Operative Mortality~Myocardial Infarction~Postoperative neurological complications~Renal failure~ARDS (Acute Respiratory Distress Syndrome)~Bleeding"|30 days||||participants|||Number
1397021|NCT01290913|Secondary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour.|To tolerate refers to the ability of the patient to ingest the final challenge of 4000mg peanut flour, with either no or mild symptoms.|after 7-8 wks of desensitization||||participants|||Number
1397584|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 2|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.|Week 2|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 2 were analyzed.|||ng/mL||Standard Deviation|Mean
1397022|NCT01290913|Primary|Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg)|To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.|First day of desensitization||||participants|||Number
1397023|NCT01290887|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|"Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive.~Predose samples for the reslizumab-experienced participants came from the previous studies."|Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall|Safety analysis set of participants with assessments at stated timeframes|||participants|||Number
1397024|NCT01290887|Secondary|Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits."|Weeks 24, 48, 72, 96, End of Study and Endpoint|Safety analysis set of participants with assessments at stated timeframes|||units on a scale||Standard Deviation|Mean
1397025|NCT01290887|Secondary|Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||units on a scale||Standard Deviation|Mean
1397026|NCT01290887|Secondary|Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||units on a scale||Standard Deviation|Mean
1397027|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit.~Significance criteria~Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages)~Sitting heart rate-low: <50 and decrease of >=30 beats/min~Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17)~Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18)~Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18)~Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17)~Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17)~Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18)~Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18)~Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17)~Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18)~Body temperature-low: <96.5° Fahrenheit (all ages)~Body temp-high: >100.5° F (all ages)"|Week 4 to Week 65|Safety analysis set, including participants who contributed to the analysis|||participants|||Number
1397028|NCT01290887|Secondary|Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||# puffs/day||Standard Deviation|Mean
1397029|NCT01290887|Secondary|Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||liters/second||Standard Deviation|Mean
1397030|NCT01290887|Secondary|Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||liters||Standard Deviation|Mean
1397031|NCT01290887|Secondary|Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||percentage of predicted FEV1||Standard Deviation|Mean
1397032|NCT01290887|Secondary|Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint|FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.|Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint|Safety analysis set of participants with assessments at stated timeframes|||liters||Standard Deviation|Mean
1397033|NCT01290887|Primary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.~Total bilirubin: >=34.2 μmol/L~White blood cells- low: <=3.0*10^9/L~White blood cells-high: >=20*10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Platelets: >=700*10^9/L~Absolute neutrophil count: <=1.0*10^9/L~Eosinophils: >=10~Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline"|Weeks 4, 8, 24 and 48|Safety analysis set, including participants who contributed to the analysis|||participants|||Number
1397034|NCT01290887|Primary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set|||participants|||Number
1397035|NCT01290874|Secondary|Change in Moderate Asthma Deterioration|Average Change in Moderate Asthma Deterioration Per Participant Over 12 Months. The definition of a moderate asthma deterioration should include one or more of the following: deterioration in symptoms, deterioration in lung function, or increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization.|from baseline to 12 months|Inadequate baseline data was collected so that the change in this variable could not be assessed.||||||
1397036|NCT01290874|Secondary|Change in Rescue Medication Use|Average Change in Rescue Medication Use Per Participant Over 12 Months. Monthly questionnaires will evaluate the amount of rescue medication subjects have used on average, measured in puffs per day.|from baseline to 12 months|335 and 328 participants are missing data on rescue medication use in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
1397037|NCT01290874|Secondary|Change in Symptom-Free Day Questionnaire (SFDQ)|"Average Change in Symptom-Free Days Per Participant Over 12 Months Using the Symptom-Free Day Questionnaire (SFDQ).~The asthma symptom free day questionnaire (SFDQ) quantifies the number of days with neither daytime nor nighttime asthma symptoms, nor awakenings due to asthma symptoms."|from baseline to 12 months|The instrument used to collect data proved to be unreliable. The statistic for internal consistency demonstrated less than 30% internal consistency.||||||
1397038|NCT01290874|Secondary|Change in Asthma Symptom Utility Index (ASUI)|"Average Change in Asthma Symptom Utility Score Per Participant Over 12 Months Using the Asthma Symptom Utility Index (ASUI).~The ASUI is an 11-item preference-based outcome measure used in clinical trials and cost-effectiveness studies for asthma and is designed to assess the frequency and severity of cough, wheeze, dyspnea, nighttime awakenings, and side effects, weighted according to patient preferences.~4-point Likert scale to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe); scores range from 0 (worst possible symptoms) to 1 (no symptoms)."|from baseline to 12 months|257 and 265 participants are missing data on ASUI in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
1397039|NCT01290874|Secondary|Change in Asthma Quality of Life (AQLQ)|"Average Change in Asthma Quality of Life Score Per Participant Over 12 Months Using the Asthma Quality of Life Questionnaire (AQLQ).~The AQLQ has 32 questions in four domains (symptoms, activity limitation, emotional function, and environmental stimuli) and measures the functional problems that are troublesome to individuals with asthma. Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items); 7-point Likert scale (7 = not impaired at all - 1 = severely impaired); scores range 1-7, with higher scores indicating better quality of life."|from baseline to 12 months|242 and 239 participants are missing data on AQLQ in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
1397040|NCT01290874|Secondary|Change in Asthma Control Questionnaire (ACQ)|"Average Change in Asthma Control Score Per Participant Over 12 Months Using the Asthma Control Questionnaire (ACQ).~The ACQ has six questions regarding symptoms, rescue short-acting β-agonist use and one about FEV1 % predicted. A 7-point scale (0 = no impairment, 6 = maximum impairment) is used for each question and the ACQ score is the mean value of these questions - hence between 0 (totally controlled) and 6 (severely uncontrolled)."|from baseline to 12 months|334 and 326 participants are missing data on ACQ in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||units on a scale||95% Confidence Interval|Mean
1397041|NCT01290874|Secondary|Change in FEV1|Average change in lung function (FEV1) evaluated by spirometry per participant over 12 months|from baseline to 12 months|255 and 253 participants are missing data on change in FEV1 in the Tiotropium and Salmeterol or Formoterol arms, respectively.|||liters||95% Confidence Interval|Mean
1397042|NCT01290874|Primary|Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year)|We summarize the survival experience using mean number of exacerbations/person-year and compare it using the log-rank test comparing kaplan-meier survival curve.|evaluated monthly (on average) via questionnaire for 12 months|intention-to-treat|||event per person-year||95% Confidence Interval|Mean
1397049|NCT01290796|Secondary|Percentage of Patients With Impression of Improvement With Procedure at 36 Months|"Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be satisfied if they felt that their urinary tract conditio0n was very much better or much better than how it felt before the surgery."|0-36 Months|Patients who completed 36 month evaulations|||percentage of participants|||Number
1397050|NCT01290796|Secondary|Percentage of Patients With Impression of Improvement With Procedure at 12 Months|"Patient satisfaction was assessed using the Patient Global Impression of Improvement (PGII) questionnaire. Patients were considered to be satisfied if they felt that their urinary tract condition was very much better or much better than how it felt before the surgery."|0-12 Months|Patients who completed 12 month evaulations|||percentage of participants|||Number
1397051|NCT01290796|Secondary|Change in Incontinent Impact Questionnaire at 36 Months|Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 36-months post-surgery.|0-36 months||||units on a scale||Standard Deviation|Mean
1397052|NCT01290796|Secondary|Change in Incontinent Impact Questionnaire at 12 Months|Mean change in overall IIQ-7 summary score (range 0 - 100). Scores on the IIQ-7 range from 0 (best outcome) to 100 (worst outcome). For this outcome measure, IIQ-7 at baseline was compared to that administered at 12-months post-surgery.|0-12 months||||units on a scale||Standard Deviation|Mean
1397053|NCT01290796|Secondary|Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months|Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).|0-36 Months||||percentage of participants||95% Confidence Interval|Number
1397054|NCT01290796|Secondary|Change in Post-operative Pain|"Mean change in Overall McCarthy Surgical Pain Scale from Day 0 to Day 7. McCarthy Pain Scale is a 50 millimeter line with No Pain Sensation noted at the 0 mm mark and Most Intense Pain Imaginable noted at the 50 mm mark. Each day, subjects are asked to mark their level of pain somewhere along the line. Change in pain level is reported in millimeters."|0-7 days||||millimeters||Standard Deviation|Mean
1397055|NCT01290796|Secondary|Operative, Perioperative and Long-term Complications Through 36 Months|Percentage of Patients with Procedure and/or Device Related Adverse Events through 36 months|Day 15 through 36-months post procedure||||percentage of participants||95% Confidence Interval|Number
1397056|NCT01290796|Secondary|Operative, Perioperative and Long-Term Complications Perioperatively|Percentage of Patients with Procedure and/or Device Related Adverse Events Perioperatively|1-15 days||||percentage of participants||95% Confidence Interval|Number
1397057|NCT01290796|Secondary|Operative, Perioperative and Long-Term Complications During Operative Procedure|Percentage of Patients with Procedure and/or Device Related Adverse Events During the Operative Procedure|1 day||||percentage of participants||95% Confidence Interval|Number
1397058|NCT01290796|Primary|Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months|Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).|12-months post procedure||||percentage of participants||95% Confidence Interval|Number
1397059|NCT01290796|Primary|Percentage of Patients Free of Stress Urinary Incontinence|Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.|12-months post surgical procedure||||percentage of participants||95% Confidence Interval|Number
1397060|NCT01290757|Secondary|AUC0-∞ of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1397061|NCT01290757|Secondary|Cmax of Free Dabigatran in Plasma.|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1397062|NCT01290757|Secondary|AUC0-tz of Free Dabigatran.|Area under the concentration-time curve of free dabigatran in plasma from time 0 to the time of the last quantifiable data point. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1397063|NCT01290757|Secondary|Area Under the Curve 0 to Infinity (AUC0-∞) of Total Dabigatran.|Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity. Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1397064|NCT01290757|Primary|Maximum Measured Concentration (Cmax) of Total Dabigatran in Plasma|Adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1397065|NCT01290757|Primary|Area Under the Curve 0 to tz (AUC0-tz) of Total Dabigatran|Area under the concentration-time curve of total dabigatran in plasma from time 0 to the time of the last quantifiable data point, adjusted for treatment, period and sequence (all fixed effects), and random subject effect.|60 hours|This subject set, the pharmacokinetic set (PKS), includes all subjects of the treated set who provide at least one evaluable observation for at least one of the three PK endpoints of total dabigatran, which is obtained in a period without important protocol violations relevant to the evaluation of bioequivalence.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1397066|NCT01290731|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels (defined as an ALT value less than or equal to the Upper Limit of Normality [ie, 40 IU/mL] at EOT). At baseline, 15/49 participants had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1397585|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 1|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.|Week 1|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 1 were analyzed.|||ng/mL||Standard Deviation|Mean
1397067|NCT01290731|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for all participants who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study. Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12).|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng.h/mL||Full Range|Median
1397068|NCT01290731|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) TMC435 predose plasma concentration (C0h) values and the TMC435 maximum plasma concentration (Cmax) values for all participants who received TMC435 for up to 12 weeks. “Overall” is the median exposure estimate using all available data for each participant in the study.Sparse blood samples were collected during the study (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12).|Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
1397069|NCT01290731|Secondary|The Number of Participants Demonstrating Viral Relapse|The table below shows the number of participants who demonstrated viral relapse, defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at end of treatment (EOT) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of sustained virologic response (SVR) assessment . The incidence of viral relapse was calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1397070|NCT01290731|Secondary|The Number of Participants With Viral Breakthrough|Viral breakthrough was defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in particpants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The table below shows that no viral breakthrough was noted in any participants during the treatment period of the study.|Day 1 until end of treatment (EOT [Week 24 or 48])|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1397071|NCT01290731|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (defined as less than 1.2 log10 IU/mL during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT [Week 24 or 48]).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397072|NCT01290731|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants with greater than or equal to 2 log10 IU/mL drop from baseline in plasma HCV RNA at each time point during treatment, at the end of treatment (Week 24 or 48), and post-treatment follow-up.|Days 3 and 7, Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397073|NCT01290731|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|The table below shows the percentage of participants with a SVR24 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|Week 48 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397074|NCT01290731|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|The table below shows the percentage of participants with an SVR12 defined as participants with undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) 12 weeks after the last dose of treatment (Week 36 or 60).|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397075|NCT01290718|Secondary|Progression-Free Survival|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
1397077|NCT01290718|Secondary|Time to Disease Progression|Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
1397078|NCT01290718|Primary|Percentage of Participants With Overall Response|The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).|Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death|Data were not analyzed due to early termination of the study.||||||
1397079|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Hours missed from work because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work). The possible WPAI WPAI absenteeism score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in WPAI absenteeism. The average WPAI absenteeism score from baseline to Week 60/72 was calculated for each participant and then the average of those values calculated for each treatment group. The area under the curve (AUC60/AUC72) over time from baseline to Week 60/72 was derived from a piecewise-linear model allowing the slopes to change at Week 4, 12, 24, 36, 48 and 60. The null hypothesis was there is no statistically significant difference between the treatment arms in the area under the curve (AUC) from baseline to Week 72 (AUC72) in WPAI absenteeism score.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397080|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. The possible impairment in WPAI daily activity score range from baseline to Week 60 was 0-6000 and to Week 72 was 0-7200, with the higher scores indicating more impairment in daily activities. The average WPAI impairment in daily activity score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI impairment in daily activity score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment arms in the AUC for the change from baseline to Week 72 (AUC72) in WPAI impairment in daily activity scores. The Table below shows the WPAI Impairment in daily activity scores at Week 72 (as well as at Week 60) and the statistical analysis between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397081|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). The average WPAI score from baseline to Week 72 was calculated for each participant and then the average of those values were calculated to show the average WPAI score for each treatment group. The null hypothesis was there is no statistically significant difference between the treatment groups in the AUC for the change from baseline to Week 72 (AUC72) in WPAI Productivity Scores. The Table below shows WPAI Productivity Scores at Week 72 (as well as at Week 60) from the model used to calculate the AUC and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397082|NCT01290679|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment and throughout follow-up to rate the severity and impact of fatigue experienced in the preceding 2 weeks. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst fatigue]; the possible score range from baseline to Week 60 would be 60-420 and to Week 72 would be 72-504. The average FSS total score from baseline to Week 60 and to Week 72 was calculated for each participant and then the average of those values were calculated to show the average FSS total score for each treatment group. The null hypothesis was that there would be no difference between the treatment arms in the FSS total score. The Table below shows the lease squares (LS) mean estimates of the area under the curve (AUC) at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397083|NCT01290679|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) of CL values of TMC435. NOTE: the pre-dose CL values taken at Weeks, 2, 4, 8, and 12 were averaged and then the mean values from all participants were averaged to provide the final value reported below.|At protocol-specified time points at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||L/h||Standard Deviation|Mean
1397110|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397084|NCT01290679|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) of C0h values of TMC435. NOTE: the timing of collection of blood samples post-dose for analysis at Week 2, 4, 8, and 12 was not specifed; only the interval was between blood samples was specified (ie, 2 samples collected 2 hours apart at Week 2, 4, 8, and 12).|Blood samples tested were taken before administration of TMC435 and at 2 random time points after dosing (taken atleast 2 hours apart from each other) at Week 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng/mL||Standard Deviation|Mean
1397085|NCT01290679|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows the mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435.|At protocol-specified time points from the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng*h/mL||Standard Deviation|Mean
1397086|NCT01290679|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Weeks||95% Confidence Interval|Median
1397087|NCT01290679|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 164 of 257 participants in the TMC435 treatment group and 79 of 134 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397088|NCT01290679|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||Standard Error|Mean
1397089|NCT01290679|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397090|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows the median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397091|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows the median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397092|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397093|NCT01290679|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows the median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397094|NCT01290679|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397095|NCT01290679|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397096|NCT01290679|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397097|NCT01290679|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397098|NCT01290679|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397099|NCT01290679|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397100|NCT01290679|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397101|NCT01290679|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397102|NCT01290679|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Weeks 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397103|NCT01290679|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397104|NCT01290679|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397105|NCT01290679|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397106|NCT01290679|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C Virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of HCV-Infected participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397107|NCT01290679|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1397108|NCT01290679|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows changes from baseline in log10 HCV RNA.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1397109|NCT01290679|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397217|NCT01289782|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time in weeks to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Weeks||95% Confidence Interval|Median
1397111|NCT01290679|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397112|NCT01290679|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397113|NCT01290666|Secondary|Duration of Drainage Post Procedure||Follow up out to 12 months post procedure|||||||
1397114|NCT01290666|Primary|Fistula Closure||12 months post procedure||||participants|||Number
1397115|NCT01290640|Primary|In Vivo Angular Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|"Angular kinematics for fixed bearing and rotating platform TKA system - Axial Rotation~The values that were reported indicate the rotation of the femur atop the tibial tray from the start of the activity to the end of the activity. If the femur rotated externally (posterior rollback of the lateral condyle, generally pivoted about the medial condyle), the number was reported as positive. If the femur rotated internally (anterior slide of the lateral condyle, generally pivoted about the medial condyle), the number was reported as negative."|March 2013||||degrees|Participants|Standard Deviation|Mean
1397116|NCT01290640|Primary|In Vivo Linear Kinematics for Fixed-bearing and Rotating Platform (RP) TKA System During 4 Weight-bearing Activities.|The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. If the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|March 2013|Per protocol.|||mm|Participants|Standard Deviation|Mean
1397117|NCT01290627|Primary|Normalized Lateral Patella Contact Point Translation|"full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the lateral contact point generally moves closer to the top of the patella (hence, the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.||||ratio of patella height|Participants|Standard Deviation|Mean
1397118|NCT01290627|Primary|Normalized Medial Patella Contact Point Translation|"full extension to maximum flexion. The position of the patellar contact point was determined by locating the closest point to the femur on the patella throughout flexion. There are 2 patello-femoral contact points: a point on the medial aspect of the patella and a point on the lateral aspect of the patella. Throughout flexion, the medial contact point generally moves closer to the top of the patella (hence the positive value for the results). The translation of this contact point is normalized to report a ratio between -1 and 1. In other words, the distance the point has traveled compared to the total height of the patella. For example, if the patella is 8 cm in height and the point travels approximately 2 cm upwards during flexion, the value would be reported as +2/8 = +0.25. Definition of normalized: multiply (a series, function, or item of data) by a factor that makes the norm or some associated quantity such as an integral equal to a desired value (usually 1)."|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.||||ratio of patella height|Participants|Standard Deviation|Mean
1397119|NCT01290627|Primary|Patella Tilt With Respect to Femur|full extension to maximum flexion|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.||||degrees|Participants|Standard Deviation|Mean
1397120|NCT01290627|Primary|Patella Rotation With Respect to Femur|Patellar rotation from full extension to maximum flexion. A positive measurement of patellar rotation refers to positive flexion of the patella about the medial-lateral axis, where the patella component rotates so that the top of the patella rotates toward the femur and the bottom rotates away. Conversely, a negative measurement refers to negative flexion of the patella about this axis, where the patellar component rotates so that the top of the patella moves away from the femur and the bottom moves towards.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.||||degrees|Participants|Standard Deviation|Mean
1397121|NCT01290627|Primary|Patella Flexion With Respect to Femur|Full extension to maximum flexion.|Average post-operative time for LCS-PS group was 56 months. Average post-operative time for PS RP group was 55.7 months.||||degrees|Participants|Standard Deviation|Mean
1397122|NCT01290614|Secondary|Number of Participants With PTH Measurement During the Study Period|The primary process outcome was measurement of PTH during the study period.|one year||||participants|||Number
1397123|NCT01290614|Primary|Systolic Blood Pressure (SBP)|Average SBP for those with a baseline BP > 130/80|one year|Baseline blood pressure >130/80 mmHg|||mmHg||Standard Deviation|Mean
1397124|NCT01290601|Other Pre-specified|Fever Clearance Time (FCT)|Measure of body temperature every 12 hours through day 7 was used to determine the time (to nearest 12 hours) from initiation of treatment until subjects temperature decreased to 37.2C and remained at or below that level for a minimum of 24 hours.|through day 7|Intent to treat population|||Hours||Standard Deviation|Mean
1397311|NCT01289067|Secondary|Overall Survival|Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter.|24 months||||days||Full Range|Median
1397125|NCT01290601|Secondary|Parasite and Gametocyte Clearance Time (PCT and GCT)|Serial blood smears to detect the presence of P. vivax parasites and gametocytes, conducted every 12 hours up to and including day 7, until blood smear became negative were utilized to determine the time to clearance. PCT and GCT were considered cleared if 2 consecutive blood smears were negative.|up to day 7 after baseline smear|Intent to treat population|||Hours||Standard Deviation|Mean
1397126|NCT01290601|Secondary|Safety and Tolerability of Tafenoquine as Defined by Most Common Adverse Events (AEs)|To evaluate the safety and tolerability of the tafenoquine dosing regimens as defined by the most common AE's overall, occurring in >10% of subjects in either treatment group|90 Days||||AEs|||Number
1397127|NCT01290601|Secondary|Number of Subjects Without Relapse of P. Vivax|"Number of subjects without relapse of P. vivax at 2, 3 and 4 months~- Blood smears were obtained at Days 28, 60, 90 and 120 to confirm the continued absence of P. vivax parasitemia"|Day 28, Months 2, 3 and 4|Intent to treat population|||participants|||Number
1397128|NCT01290601|Primary|Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate|A subject will be considered a success (cure) if they have an Adequate Clinical Response (ACR). Tafenoquine was efficacious if the lower bound of the two-sided 90% confidence interval for the day 28 cure rate was not less than 85%|28 Days|Intent to treat population|||Participants|||Count of Participants
1397129|NCT01290536|Secondary|Radiographic Response|Radiographic response of treated lesions on cross-sectional imaging (computed tomography or magnetic resonance imaging) following treatment with Yttrium-90 glass microspheres (TheraSphere) was assessed based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no change in target lesions; Progressive Disease (PD), increase in target lesions.|6 months after treatment|Response data are presented by primary disease sites: Colorectal (mCRC), Neuroendocrine (NET), and all other tumors. One patient with mCRC did not have follow-up cross-sectional imaging. Therefore, radiographic response data was available for 20 of 21 patients with mCRC.|||participants|||Number
1397130|NCT01290536|Primary|Number of Participants With Adverse Events|Adverse effects of treatment with Yttrium-90 glass microspheres (TheraSphere) were collected prospectively for 6 months after each treatment administration.|6 months||||participants|||Number
1397131|NCT01290523|Secondary|Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1||6 months||||participants|||Number
1397132|NCT01290523|Primary|Number of Participants With Adverse Events|Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain|6 months||||participants|||Number
1397133|NCT01290484|Primary|Change in Volume of Lymphatic Malformation|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).|Baseline, 20 weeks||||percentage of volume change|||Number
1397134|NCT01290341|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).~Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6|Full Analysis Set (FAS) using a Modified Intent to Treat (MITT) population.|||percentage of subjects|||Number
1397135|NCT01290341|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.~Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.|||percentage of subjects|||Number
1397136|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from baseline to Day 7 post end IV infusion|Only subjects with both a baseline and at least one post baseline value are included.|||mg||Standard Deviation|Mean
1397137|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from baseline to 24 hours post end IV infusion|Only subjects with both a baseline and at least one post baseline value are included.|||mg||Standard Deviation|Mean
1397138|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from baseline to 2 hours post end IV infusion|Only subjects with both a baseline and at least one post baseline value are included.|||mg||Standard Deviation|Mean
1397139|NCT01290315|Primary|Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)||Change from Baseline to Day 30|Only subjects with both a Baseline and at least one post-Baseline value are included.|||mg||Standard Deviation|Mean
1397140|NCT01290263|Primary|AMG 386 Dose Limiting Toxicity (DLT) [Cohort B Phase I]|A DLT is defined as an adverse event that (a) is related to the AMG 386 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 28 days of the study treatment, and (c) meets any of the following criteria: >= grade 3 thrombocytopenia; grade 4 neutropenia lasting > 7 days; grade 4 anemia lasting > 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5x10^9/L; clinically significant grade 3 non-hematologic toxicity despite maximal medical therapy lasting > 7 days, with the exception of grade 3 proteinuria which was considered a DLT if lasting > 14 days; grade 3 non-hematologic toxicity resulting in study drug discontinuation; grade 4 non-hematologic toxicity; >= grade 1 new CNS hemorrhage; >= grade 2 non-CNS hemorrhage.|Participants were assessed weekly while on study; the observation period for DLT evaluation was the first 28 days of study treatment.|All phase I Cohort B participants who completed 28 days on study treatment were evaluable. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.|||participants|||Number
1397141|NCT01290263|Secondary|Progression-Free Survival (PFS) [Cohort A and Cohort B]|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression or death. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks. On Cohort A and B participants were followed for progression up to 36 days and 166 days.|All participants who received at least one dose of the study drug were evaluable for PFS.|||days||Full Range|Median
1397142|NCT01290263|Secondary|Overall Survival (OS) [Cohort A and Cohort B]|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 to 4 months from the end of treatment until death or lost to follow-up. On Cohort A and B participants were followed up to 554 days and 442 days.|All participants who received at least one dose of the study drug were followed for OS.|||days||Full Range|Median
1397143|NCT01290263|Secondary|Best Radiographic Response [Cohort A and Cohort B]|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR, PR or PD, stable non-enhancing lesions, and stable clinically.|Disease was assessed radiographically for response every 8 weeks.|All participants who received at least one dose of the study drug were evaluable for response.|||participants|||Number
1397144|NCT01290263|Primary|AMG 386 Maximum Tolerated Dose (MTD) [Cohort B Phase I]|The MTD of weekly AMG 386 intravenously (IV) in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).|Participants were assessed weekly while on study; the observation period for MTD evaluation was the first 28 days of study treatment.|All phase I Cohort B participants who received at least one dose of the study drug were evaluable for MTD. A participant was replaceable if they are taken off of study treatment due to progressive disease or withdrawal from study during before they completed the 28 day DLT period.|||mg/kg intravenously on days 1 and 15|||Number
1397145|NCT01290263|Primary|6-Month Progression-Free Survival (PFS6) [Cohort A and Cohort B]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non- enhancing lesions, and stable or improved clinically. PD: > 25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: d|6 months||||proportion of participants||95% Confidence Interval|Number
1397146|NCT01290237|Secondary|AUC/MIC for Vancomycin in the Study Population|AUC/MIC using hypothetical MIC = 1 mg/L|within 48 hours after receiving the first dose of vancomycin|Number of measurements reflects the number of participants with blood samples available for testing|||AUC/MIC ratio||Standard Deviation|Mean
1397147|NCT01290237|Primary|Count of Participants With Vancomycin Trough Between 15 and 20|proportion of participants whose vancomycin trough was between 15 and 20 mcg/mL, 8 hours after the first vancomycin dose, in loading dose group as compared to control group|8 hours after the first dose of vancomycin|Loading dose - trough at 8 hours was not collected for 11 participants: vancomycin was discontinued prior to second dose (7), participant changed their mind (1), other reason (3) Among participants allocated to conventional treatment, trough at 8 hours was not collected for 2: vancomycin discontinued prior to second dose (1), changed mind (1)|||Participants|||Count of Participants
1397148|NCT01290224|Secondary|Analgesic Use Over Time||On days 1-11 and for 10 weeks after therapy||||participants|||Number
1397149|NCT01290224|Secondary|Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0|CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Day 1 to Day 10||||participants|||Number
1397150|NCT01290224|Secondary|Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions|The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported.|Day 1 and Week 10||||percentage of a scale||Standard Deviation|Mean
1397151|NCT01290224|Secondary|Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question|The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week.|Week 1 and Week 10||||percentage of reduction in symptom||Standard Deviation|Mean
1397152|NCT01290224|Secondary|Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H).|Day 1 and Day 10||||percentage of reduction in symptom||Standard Deviation|Mean
1397153|NCT01290224|Secondary|Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question|The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated.|On days 1 and 2||||units on a scale||Standard Deviation|Mean
1397154|NCT01290224|Primary|Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire|CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours.|On days 1 and 2||||Percentage of Participants|||Number
1397155|NCT01290094|Secondary|Correlation Coefficient of Participant's Profile With Compliance|Participant's profile included age, year since menopause, fracture history, and BMD at baseline.|Baseline up to Month 12|ITT population.|||correlation coefficient|||Number
1397156|NCT01290094|Secondary|Percentage of Participants Who Received All Planned Study Medication (Compliance)||Baseline up to Month 12|ITT population.|||percentage of participants|||Number
1397157|NCT01290094|Secondary|Percent Change From Baseline in Total Hip T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.|||percent change||Standard Deviation|Mean
1397158|NCT01290094|Secondary|Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis."|Baseline, Month 12, Month 24|ITT population. Here “n” included participants who were evaluable at specified time point for the given arm.|||percent change||Standard Deviation|Mean
1397159|NCT01290094|Primary|Percent Change From Baseline in Mean Hip BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
1397160|NCT01290094|Primary|Percent Change From Baseline in Mean Hip Bone BMD at Month 12|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.|||percent change||Standard Deviation|Mean
1397161|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24|"Percent change was calculated as [(measure at time t - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 24|ITT population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
1397162|NCT01290094|Primary|Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12|"Percent change was calculated as [(measure at time t minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline."|Baseline, Month 12|ITT population.|||percent change||Standard Deviation|Mean
1397163|NCT01290068|Secondary|Median Total Spectacle Cost Prior to Any Reimbursement|Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.|Month 6 after second eye implantation|This analysis population includes all randomized and implanted participants. If total cost was missing for a spectacle independent subject, €0 was imputed. If total cost was missing for a spectacle-dependent subject, mean cost for all spectacle dependent-subjects in that group with a known total cost for the same type of spectacles was imputed.|||euros||Inter-Quartile Range|Median
1397164|NCT01290068|Primary|Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)|Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized.|||units on a scale||Standard Error|Least Squares Mean
1397165|NCT01290068|Primary|Proportion of Participants Reporting Spectacle Independence at All Distances|Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled ‘No spectacles’, was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data.|||percentage of participants|||Number
1397166|NCT01290068|Primary|Percentage of Participants Classified as Responders|Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.|Month 6 after second eye implantation|This analysis population includes all randomized participants to whom the randomized IOL was presented and/or implanted during the first eye surgery (from a try to a full success), as randomized. Last observation carried forward (LOCF) was used for missing data.|||percentage of participants|||Number
1397167|NCT01290029|Secondary|Percent Change From Baseline in Ionized Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Standard Deviation|Mean
1397168|NCT01290029|Secondary|Percent Change From Baseline in Albumin Corrected Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Standard Deviation|Mean
1397169|NCT01290029|Secondary|Percent Change From Baseline in Total Calcium||Baseline (predose) and 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Standard Deviation|Mean
1397170|NCT01290029|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone||Baseline (predose) and at 2, 8, 12 and 48 hours post-dose.|"Due to the randomization to 1 of 2 sampling sequences not all participants had PD samples taken at every time point. n indicates participants with non-missing data at the time point of interest."|||percent change||Inter-Quartile Range|Median
1397171|NCT01290029|Secondary|Terminal Half-life of Cinacalcet|The terminal half-life (T1/2) of cinacalcet associated with the slope of the terminal phase.|Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The T1/2 value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.|||hours||Standard Deviation|Mean
1397172|NCT01290029|Secondary|Time to Reach Maximum Observed Plasma Concentration of Cinacalcet (Tmax)||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set|||hours||Full Range|Median
1397173|NCT01290029|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set|||ng/mL||Standard Deviation|Mean
1397174|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUCinf) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set; The AUCinf value for one participant was excluded based on the goodness-of-fit (R²) value exclusion criteria.|||hr*ng/mL||Standard Deviation|Mean
1397175|NCT01290029|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) for Cinacalcet||Baseline (predose) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Pharmacokinetics analysis set|||hr*ng/mL||Standard Deviation|Mean
1397176|NCT01290029|Primary|Number of Participants With Adverse Events|A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. Treatment-related adverse events are those the investigator assessed as being possibly related to any study mandated activity (eg, administration of investigational product, protocol-required therapies, device(s) and/or procedure). Events of interest included acute pancreatitis, convulsions, drug related hepatic disorders, fractures, hypersensitivity, hypocalcemia, ischaemic heart disease, ventricular tachyarrhythmias, cardiac failure, and hypotension.|Day 1 to day 30|All participants who received at least 1 dose of cinacalcet.|||participants|||Number
1397177|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 76 Weeks of Treatment|Fasting plasma glucose - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF|||mg/dL||Standard Error|Least Squares Mean
1397178|NCT01289990|Secondary|Fasting Plasma Glucose Change From Baseline After 52 Weeks of Treatment|Fasting plasma glucose - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline fasting plasma glucose assessment, irrespective of participation in the extension trial -LOCF|||mg/dL||Standard Error|Least Squares Mean
1397179|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 76 Weeks of Treatment|Waist circumference (cm) - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF|||cm||Standard Error|Least Squares Mean
1397180|NCT01289990|Secondary|Waist Circumference (cm) Change From Baseline After 52 Weeks of Treatment|Waist circumference (cm) - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline waist circumference assessment, irrespective of participation in the extension trial -LOCF|||cm||Standard Error|Least Squares Mean
1397181|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 76 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 76 Weeks of Treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial -LOCF|||kg||Standard Error|Least Squares Mean
1397182|NCT01289990|Secondary|Body Weight (kg) Change From Baseline After 52 Weeks of Treatment|Body Weight (kg) - Change From Baseline After 52 Weeks of Treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline body weight assessment, irrespective of participation in the extension trial. - LOCF|||kg||Standard Error|Least Squares Mean
1397183|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Diastolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF|||mmHg||Standard Error|Least Squares Mean
1397184|NCT01289990|Secondary|Diastolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Diastolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline diastolic blood pressure assessment, irrespective of participation in the extension trial -LOCF|||mmHg||Standard Error|Least Squares Mean
1397185|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 76 Weeks of Treatment|Systolic blood pressure - change from baseline after 76 weeks of treatment|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial -LOCF|||mmHg||Standard Error|Least Squares Mean
1397186|NCT01289990|Primary|Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment|Change from baseline in HbA1c after 76 weeks|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (LOCF)|||% of HbA1c||Standard Deviation|Least Squares Mean
1397187|NCT01289990|Secondary|Systolic Blood Pressure: Change From Baseline After 52 Weeks of Treatment|Systolic blood pressure - change from baseline after 52 weeks of treatment|Baseline and 52 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline systolic blood pressure assessment, irrespective of participation in the extension trial. (LOCF)|||mmHg||Standard Error|Least Squares Mean
1397188|NCT01289990|Secondary|HbA1c (%) Changes From Baseline After 76 Weeks of Treatment|Change from baseline in HbA1c (%) after 76 weeks using MMRM approach|Baseline and 76 weeks|Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial. (OC: Observed cases)|||% of HbA1c||Standard Error|Least Squares Mean
1397189|NCT01289990|Primary|Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks|Baseline and 52 weeks|"Full Analysis Set (FAS) which contained all randomised patients who received at least 1 dose of study drug and had a baseline HbA1c assessment, irrespective of participation in the extension trial.~(LOCF:Last observation carried forward)"|||% of HbA1c||Standard Error|Least Squares Mean
1397190|NCT01289912|Secondary|Comparison of Behavioral Problems Between Patients Taking RAD001 vs Placebo|"Scores for Baseline and 6 Month Timepoints are reported for the following secondary outcome measures:~Behavior Rating Inventory of Executive Function (BRIEF) (Measure of executive functions) T-scores are reported, with a mean of 50 and a standard deviation of 10. The range is 30-100 with higher scores indicating a worse outcome.~Behavioral Assessment System for Children (BASC) (Measure of emotional and behavioral problems) T-scores are reported (mean of 50, SD of 10). The range is 30-100 with higher scores indicating a worse outcome. Conversely, on the Adaptive Skills subscale of the BASC, lower scores indicate a poorer outcome.~Strengths and Difficulties Questionnaire (SDQ). Includes questions related to emotional symptoms, conduct problems, inattention/hyperactivity, peer relationship problems and prosocial behavior. Responses to these items are summed to comprise a Total Difficulties Score, which ranges from 0-40, with lower scores indicating a better outcome"|6 months||||units on a scale||Standard Deviation|Mean
1397191|NCT01289912|Secondary|Comparison of Academic Skills Between Patients Taking RAD001 vs. Placebo|Scores are reported for Baseline and 6 Month Timepoints. The secondary outcome measure was the Wide Range Achievement Test 4 (WRAT4), which was used to assess academic skills. The Reading and Math subtests were used. Standard scores are reported which have a mean of 100 and a standard deviation of 15 (range=40-160 where higher is better).|6 months||||units on a scale||Standard Deviation|Mean
1397192|NCT01289912|Secondary|Comparison of Autism Spectrum Disorders Features Between Patients Taking RAD001 vs. Placebo|Scores for the Baseline and 6 Month Timepoints are reported. The secondary outcome measure was the Social Responsiveness Scale (SRS). Standard scores are reported with a mean of 100 and standard deviation of 15. The range is 40-160 with higher scores indicating a better outcome.|6 months||||units on a scale (SRS)||Standard Deviation|Mean
1397193|NCT01289912|Secondary|Comparison of Sleep Disturbances Between Patients Taking RAD001 vs. Placebo|Comparison of sleep disturbances between patients taking RAD001 vs. placebo, measured by the Pediatric Sleep Questionnaire (PSQ) and sleep logs|6 months|Data was not collected reliably and therefore was not analyzed.||||||
1397194|NCT01289912|Secondary|Comparison of Absolute Change From Baseline in Frequency of Epileptiform Events Between Patients Taking RAD001 vs. Placebo|Comparison of absolute change from baseline in frequency of epileptiform events as recorded on seizure diaries between patients taking RAD001 vs. placebo|6 months|Data was not collected reliably and therefore was not analyzed.||||||
1397209|NCT01289821|Primary|Objective Response (OR)|OR was defined as the best tumor response (confirmed complete response [CR] or partial response [PR]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have a reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing nontarget lesions and no appearance of new lesions.|From start of treatment until 30 days after termination of study medication, an average of 47 weeks. Assessed every 8 weeks.|Primary analysis set (PAS, N=41) was a subset of the PPS and included the first 41 subjects, who were assigned to treatment|||Proportion of participants|||Number
1397195|NCT01289912|Primary|Evaluation of the Efficacy of RAD001 on Neurocognition (Cambridge Neuropsychological Test Automated Battery) in Patients With TSC Compared With Placebo.|"Scores are reported for baseline and 6 month timepoints on the Cambridge Neuropsychological Test Automated Battery (CANTAB) subscales below. For all subscales, scores are reported as the mean difference between the study subjects and a normative population matched for age, gender and IQ (e.g., subject subscale score - mean of matched normative group = reported score). Higher scores represent a better outcome.~Spatial Span (SSP) (spatial memory span) Range: -3 to 3~Spatial Working Memory (working memory) Range: -3 to 3~Pattern Recognition Memory (PRM) (visual pattern recognition memory) Range: -3 to 3~Spatial Recognition Memory (SRM) (spatial recognition memory) Range: -4 to 4~Rapid Visual Information Processing (RVIP) (sustained attention) Range: -4 to 4~Stockings of Cambridge (SOC) (spatial planning) Range: -4 to 4~Intra-Extra Dimensional Set Shift (IDED) (cognitive flexibility) Range: -5 to 5~Reaction Time (processing speed) Range: -5 to 5"|6 months||||units on a scale||Standard Deviation|Mean
1397196|NCT01289912|Primary|Evaluation of the Efficacy of RAD001 on Neurocognition in Patients With TSC Compared With Placebo.|"Baseline and 6 month Timepoint scores are reported for the following primary outcome measures:~Peabody Picture Vocabulary Test 4 (PPVT-4; Receptive Language Measure). Scores reported as (mean, SD). Range=40-160, higher scores are better.~Expressive Vocabulary Test 2 (EVT-2; Expressive Language Measure). Scores reported as (mean, SD). Range=40-160, higher scores are better.~Wide Range Assessment of Memory and Learning 2 (WRAML2; Measure of Verbal Memory and Attention ). Scores reported as (mean, SD). Range=1-19, higher scores are better.~Vineland Adaptive Behavior Scales-II (VABS-II; Measure of Adaptive Behavior). Scores reported as (mean, SD). Range = 40-160, higher scores are better.~Purdue Pegboard Test (Measure of Fine Motor Speed and Coordination). Scores reported as (mean, SD). Range = 40-160, higher scores are better."|6 months||||units on a scale||Standard Deviation|Mean
1397197|NCT01289912|Primary|Evaluation of the Safety of RAD001 on Neurocognition in Patients With TSC Compared With Placebo in Patients With TSC.|Evaluation of the safety of RAD001 compared with placebo in patients with TSC focusing on NCI CTCAE Grade 3 and 4 adverse events, serious adverse events, and Grade 3 and 4 laboratory toxicities.|6 months||||Adverse Events|||Number
1397198|NCT01289847|Secondary|Therapeutic Efficacy|Number of days on therapeutic antibiotics|12 months||||days||Standard Deviation|Mean
1397199|NCT01289847|Secondary|Therapeutic Efficacy|Visits to physicians and/or emergency room|12 months||||visits||Standard Deviation|Mean
1397200|NCT01289847|Secondary|Therapeutic Efficacy|Number of days in hospital|12 months||||days||Standard Deviation|Mean
1397201|NCT01289847|Secondary|Therapeutic Efficacy|Number of days off school|12 months||||days||Standard Deviation|Mean
1397202|NCT01289847|Secondary|Therapeutic Efficacy|Number and proportion of subjects who maintain trough IgG levels at least as high as the average of the 2 previous trough levels before the first Gammaplex infusion|From week 15 onwards|Seven subjects (28.0%) maintained trough IgG levels at all visits that were at least as high as the average of the two previous levels before the first infusion|||participants|||Number
1397203|NCT01289847|Primary|Adverse Events|Number of subjects with serious, acute, bacterial infections as a measure of efficacy|12 months|Intent to Treat (ITT)|||participants|||Number
1397204|NCT01289821|Secondary|Duration of Stable Disease (DOSD)|DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD. DOSR was defined as the time (in days) from date of start of study treatment to the date at which disease progression or death (if death occurred before progression was first documented). The date the tumor scan was performed was used for this calculation. DOSD for participants without disease progression or death before progression at the time of analysis were censored at the date of their last tumor assessment.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Per protocol set (PPS)|||Days||95% Confidence Interval|Median
1397205|NCT01289821|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of first documented objective response of PR or CR, whichever was noted earlier, to first subsequent disease progression or death (if death occurred before progression was documented). DOR was defined for responders only (that is, subjects with CR or PR). DOR for subjects without disease progression or death before progression was right censored at the date of their last tumor assessment.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Per protocol set (PPS)|||Days||95% Confidence Interval|Median
1397206|NCT01289821|Secondary|Disease Control (DC)|DC was defined as the proportion of participants who had a best response rating of CR, PR, or stable disease (SD) according to RECIST criteria that was achieved during treatment or within 30 days after termination of study treatment. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. A minimum of 8 weeks (allowing a minus 7-day time window) between start of study treatment and the first follow-up tumor assessment with SD as response was required to assign SD as best overall response.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|PAS|||Proportion of participants|||Number
1397207|NCT01289821|Secondary|Progression-free Survival (PFS)|PFS was defined as time from the date of start of study treatment to the date of first observed disease progression (radiological according to central assessment or clinical), or death due to any cause, if death occurred before progression was documented. PFS for participants without disease progression or death at the date of database cutoff were right-censored at the last date of tumor assessment. Participants who had no tumor evaluation after baseline and no clinical progression post baseline and who did not die were censored at Day 1 in the analysis. PD = At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non target lesions or the appearance of one or more new lesions will also constitute PD.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
1397208|NCT01289821|Secondary|Overall Survival (OS)|OS was calculated as the time from first date of receiving study treatment to date of death due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.|From start of treatment until 30 days after the last dose of study treatment, assessed by every 8 weeks|Full analysis set (FAS, N=54) included all subjects who received treatment.|||Days||95% Confidence Interval|Median
1397210|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) in Work Productivity and Activity (WPAI) Absenteeism Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Time missed from work in hours because of HCV infection or its treatment was assessed by measuring the change from baseline in the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire Absenteeism score (time missed from work, question #2). The number of hours missed from work because of HCV was divided by the total number of hours supposed to work, and expressed as a percentage. An area under the curve (AUC) analysis compared the WPAI absenteeism scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms WPAI absenteeism scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI absenteeism scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|Analysis Population Description: The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397211|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in daily activity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire, Question 6. Scores ranged from 0 (no effect on activities) to 10 (completely prevented me from doing my daily activities). An area under the curve (AUC) analysis compared the impairment in daily activity scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in impairment in daily activity scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in the impairment in daily activity scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397212|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment|Impairment in overall work productivity was measured using the Work Productivity and Activity Impairment (WPAI): Hepatitis C questionnaire completed by participants during study visits throughout the study. WPAI Overall Productivity Scores ranged from 0% to 100% (higher WPAI scores indicated greater impairment in productivity). An area under the curve (AUC) analysis compared the overall WPAI Overall Work Productivity Scores in each treatment group from Baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the WPAI Overall Work Productivity Scores from Baseline to Week 72. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) in WPAI Work Productivity Scores and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397213|NCT01289782|Secondary|Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores|Study participants completed FSS questionnaires during study visits before treatment began and throughout treatment and follow-up to rate the severity and impact of fatigue they experienced in the preceding 2 weeks on their daily lives. FSS total scores are the average of nine questions with a range from 1 [no fatigue] to 7 [worst possible fatigue]. An area under the curve (AUC) analysis compared the overall severity of fatigue in each treatment group from baseline to Week 72. The null hypothesis was that there would be no difference between the treatment arms in the amount of fatigue participants experienced throughout the study resulting in equal AUC from baseline to Week 72 (AUC72) for FSS total scores. The Table below shows the lease squares (LS) mean estimates of AUC at Week 72 (as well as at Week 60) and the statistical comparison between treatment groups.|Baseline to Week 60 and Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||scores on a scale*weeks||95% Confidence Interval|Least Squares Mean
1397214|NCT01289782|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows the mean (standard deviation) values for the CL of TMC435.To calculate the mean CL for all participants in the study, CL values were first derived for each participant at each visit and then a median CL value calculated across visits for each participant. The median CL value for each participant was used to calculate the mean CL for all participants in the study.|Across Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||L/h||Standard Deviation|Mean
1397215|NCT01289782|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows the mean (standard deviation) values for the C0h of TMC435.To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then a median C0H value calculated across visits for each participant. The median COh value for each participant across all visits was used to calculate the mean C0h for the study.|Before administration of TMC435 at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng/mL||Standard Deviation|Mean
1397216|NCT01289782|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours after dosing for TMC435 for all participants. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then a median AUC value calcuated across all visits for each participant. The median AUC value across all visits for each participant was used to calculate the mean AUC 24 hr all participants in the study.|Fom the time of administration up to 24 hours after dosing at Weeks 2, 4, 8, and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng*h/mL||Standard Deviation|Mean
1399649|NCT01265550|Secondary|Number of Successful Participants With Globus|Presence of globus as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1397218|NCT01289782|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 158 of 264 participants in the TMC435 treatment group and 89 of 130 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication).|||Percentage of participants|||Number
1397219|NCT01289782|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||Standard Error|Mean
1397220|NCT01289782|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397221|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows median time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397222|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows median time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397223|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397224|NCT01289782|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows median time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1397225|NCT01289782|Secondary|Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397226|NCT01289782|Secondary|Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397227|NCT01289782|Secondary|Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397228|NCT01289782|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397229|NCT01289782|Secondary|Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as greater than or equal to 2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397230|NCT01289782|Secondary|Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397231|NCT01289782|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397232|NCT01289782|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397233|NCT01289782|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397234|NCT01289782|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397235|NCT01289782|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397236|NCT01289782|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397237|NCT01289782|Secondary|Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, < 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397238|NCT01289782|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1397239|NCT01289782|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows the change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1397240|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397241|NCT01289782|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397242|NCT01289782|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397243|NCT01289782|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1397312|NCT01289067|Secondary|Progression Free Survival (PFS)|Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression.|up to 2 years||||days||Full Range|Median
1397244|NCT01289639|Secondary|Change in Hepatic Insulin Sensitivity|Hepatic insulin sensitivity was determined using stable glucose isotope measurements during the low dose hyperinsulinemic euglycemic clamp to determine the rate of endogenous glucose production in the fasting state and in response to a low dose glucose infusion. The ability of insulin to suppress glucose, which is mainly produced by the liver, thus provides a measure of hepatic insulin sensitivity and is expressed as a percentage of the basal state. Change in the ability of low dose insulin to suppress endogenous glucose production during a labeled hyperinsulinemic euglycemic clamp.|0-6 months||||% change from baseline||Standard Error|Mean
1397245|NCT01289639|Secondary|Change in Intra-abdominal Fat Area by CT Scan||0-6 months||||mm2||Standard Error|Mean
1397246|NCT01289639|Secondary|Change in Peripheral Insulin Sensitivity|Change in the rate of glucose disposal (Rd) during the low dose clamp. During a clamp procedure, insulin is infused at a dose based on body size and a glucose solution is infused and the rate adjusted every 5 minutes based on a blood glucose reading to maintain the blood glucose stable at 90 mg/dl (normal level). Using glucose isotopes and the rate of the glucose infusion, we are then able to calculate how much glucose the liver is producing and how much glucose is being taken up into tissues. This provides a measure of insulin sensitivity.|0-6 months||||mg/minute/kg lean mass||Standard Error|Mean
1397247|NCT01289639|Secondary|Change in Liver/Spleen Ratio Measure by the Density Ratio in Hounsfield Units Between the Liver and the Spleen by CT||0-6 months||||ratio||Standard Error|Mean
1397248|NCT01289639|Secondary|Change in Alanine Aminotransferase (ALT) Levels||0-6 months||||U/L||Standard Error|Mean
1397249|NCT01289639|Primary|Liver/Spleen Ratio Measured as the Ratio in Hounsfield Units Between the Liver and the Spleen on Computed Tomography (CT) Scan||6 months||||ratio||Standard Error|Mean
1397250|NCT01289574|Secondary|Percent Change in Noninflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized subjects|||Percentage change from baseline||Standard Deviation|Mean
1397251|NCT01289574|Secondary|Success on Investigator Global Assessment (IGA) at Week 12|"Overall acne rated as clear, almost clear, mild, moderate, severe, very severe.~Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline"|12 weeks|All randomized subjects|||Percentage of subjects|||Number
1397252|NCT01289574|Primary|Percent Change in Inflammatory Acne Lesion Counts|Percent change from Baseline|12 weeks|All randomized patients|||Percentage change from baseline||Standard Deviation|Mean
1397253|NCT01289548|Secondary|Plasma Concentration of MDA in the Recipients|Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the operation|All patients completed the trial and no dropout occured.|||nmol/ml||Inter-Quartile Range|Median
1397254|NCT01289548|Secondary|Plasma Concentration of SOD in the Recipients|Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients|within 24hours after the operation|All patients completed the trial and no dropout occured.|||U/ml||Inter-Quartile Range|Median
1397255|NCT01289548|Secondary|Urine Concentration of RBP Postoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.|||mg/L||Inter-Quartile Range|Median
1397256|NCT01289548|Secondary|Urine Concentration of RBP Preoperatively in the Recipients|Urine concentration of retinol binding protein (RBP) before the operation in the recipients|before the operation|No urine could be obtained from the other 46 patients because of anuria.|||mg/L||Standard Deviation|Mean
1397257|NCT01289548|Secondary|Urine Concentration of NAG Postoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients|within the first 24hours after the artery unclamping|All patients completed the trial and no dropout occured.|||U/L||Inter-Quartile Range|Median
1397258|NCT01289548|Secondary|Urine Concentration of NAG Preoperatively in Recipients|Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation|before operation|Urine could not be obtained from the other 46 patients because of anuria.|||U/L||Standard Deviation|Mean
1397259|NCT01289548|Secondary|Total Costs During the Hospitalization|Total costs from the admission to the discharge of the recipients|from the admission to the discharge of the patients|All the patients completed the study and no dropout occured.|||RMB yuan||Inter-Quartile Range|Median
1397260|NCT01289548|Primary|Plasma Concentration of NGAL in the Recipients|Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping|within the first 24hours after the operation|All patients completed the trial and no dropout occured.|||ng/ml||Inter-Quartile Range|Median
1397261|NCT01289548|Primary|Urinary Output of the Recipients Postoperatively|Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation|within the first 3days after the operation|All patients completed the trial and no dropout occured.|||ml||Inter-Quartile Range|Median
1397262|NCT01289548|Secondary|Length of Postoperative Hospital Stay|time from the day of operation to the day of discharge for the recipients|before discharge|All the patients completed the study and no dropout occured.|||day||Inter-Quartile Range|Median
1397263|NCT01289548|Secondary|Delayed Graft Function|Delayed Graft Function according to the clinical symptoms|before discharge|All the patients completed the study and no dropout occured.|||participants|||Number
1397264|NCT01289548|Secondary|Acute Rejection of Transplanted Kidney|biopsy-confirmed, clinically symptomatic|before discharge|All the patients completed the study and no dropout occured.|||participants|||Number
1397265|NCT01289548|Primary|Plasma Creatine Concentration of the Recipients|Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping|within the first 3days after the operation|All patients completed the trial and no dropout occured.|||μmol/l||Inter-Quartile Range|Median
1397266|NCT01289522|Secondary|Biomarkers||two years|||||||
1397267|NCT01289522|Secondary|Overall Survival||1 year|||||||
1397268|NCT01289522|Secondary|Progression-free Survival||1 year|||||||
1397313|NCT01289067|Secondary|Number of Days to Maximum Decline in PSA|Response rate - Maximum decline in PSA that occurs during treatment.|baseline and 3 months|Only responders included|||days||Full Range|Median
1397269|NCT01289522|Secondary|Best Overall Response|Tumor response is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.|12 weeks|2 patients not assessable for response at 12 weeks|||percentage of Best overall ORR||95% Confidence Interval|Number
1397270|NCT01289522|Secondary|Grade 1 to 5 Toxicity|All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.|24 weeks (average)||||percentage of events|||Number
1397271|NCT01289522|Primary|Objective Tumor Response Rate|"The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR."|12 weeks (after completion of the 4th cycle of chemotherapy)||||percentage of participants||95% Confidence Interval|Number
1397272|NCT01289418|Primary|the Occurrence of Serious Adverse Events (SAE)||6 months||||participants|||Number
1397273|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.||day 8, 15 and 29||||participants|||Number
1397274|NCT01289418|Primary|Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.||at day 8, 15 and 29||||participants|||Number
1397275|NCT01289392|Primary|Sleep Apnea|Number of events per hour of sleep|6 months||||number of events||Standard Deviation|Mean
1397276|NCT01289392|Secondary|Inflammatory Markers|Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8|6 months after the basal evaluation|||||||
1397277|NCT01289392|Primary|Objective Sleep Parameters|Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation|6 months after the basal evaluation|||||||
1397278|NCT01289275|Secondary|30-day Abstinence|All participants will receive an assessment Interview 2-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone.|2-months post enrollment|||||||
1397279|NCT01289275|Secondary|Self-reported Re-hospitalization||6-months post enrollment|||||||
1397280|NCT01289275|Secondary|Continuous Abstinence Rates for Those Who Made Quit Attempts||6-months post enrollment|||||||
1397281|NCT01289275|Secondary|Percentage of Smokers Making a 24-hour Quit Attempt||6-months post enrollment|||||||
1397282|NCT01289275|Primary|30-day Abstinence|All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Intention to treat analysis.|6-months post enrollment|all randomized subjects|||percent of participants abstinent 30 day||95% Confidence Interval|Number
1397283|NCT01289210|Secondary|Assess the Safety and Feasibility of the Combination Regimen.||Safety assessed throughout study period.|||||||
1397284|NCT01289210|Primary|Number of Participants Whose Tumors Responded to Treatment With Intratumoral Injection of VTX-2337 in Combination With Low-Dose Local Radiation.|Tumor response was assessed via CT scans of the chest, abdomen, pelvis or other medically appropriate imaging modality to evaluate all areas of disease. Cheson Criteria were used for calculation of response.|Tumor assessment conducted at 12 weeks and every 3-6 months thereafter|Subjects who completed the first 4 weeks of treatment (radiation + 3 VTX-2337 injections) were evaluable for tumor response and immune response. The study was closed due to slow accrual. 2 subjects were enrolled; 1 was evaluable for the primary endpoint, the other discontinued prematurely and was evaluated for safety only (a secondary endpoint).|||participants|||Number
1397285|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥2.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
1397286|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
1397287|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥1.0%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
1397288|NCT01289119|Secondary|Percentage of Participants With a Decrease in HbA1c ≥ 0.5%|Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16.|Baseline and Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
1397314|NCT01289067|Primary|Efficacy of Satraplatin as Second Line Therapy in Men With CRCP|Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.|3 months||||participants|||Number
1397289|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
1397290|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤7.0% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
1397291|NCT01289119|Secondary|Percentage of Participants With HbA1c ≤6.5% at Week 16|Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16.|Week 16|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage of participants|||Number
1397292|NCT01289119|Secondary|Change From Baseline in Body Weight|The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy.|Baseline and Weeks 8 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline weight assessment. Last observation carried forward was utilized.|||kg||Standard Error|Least Squares Mean
1397293|NCT01289119|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).|Randomization to Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline assessment.|||percentage of participants|||Number
1397294|NCT01289119|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8, 12 and 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline FPG assessment. Last observation carried forward was utilized.|||mmol/L||Standard Error|Least Squares Mean
1397295|NCT01289119|Secondary|Change From Baseline in HbA1c Over Time|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Weeks 4, 8 and 12.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1397296|NCT01289119|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.|Baseline and Week 16.|The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1397297|NCT01289080|Secondary|The Abnormalities Found in Vital Signs, ECGs, and Clinical Laboratory Tests Are Reported as AEs Upon Study Physicians Discretion.|An adverse event (AE) was an exacerbation of an existing problem or any new problem, experienced by a participant when enrolled in a trial, whether or not it was considered drug related by the study physician.|AEs were recorded from Screening (ICF was signed) to Follow-up 31 (+ 2) days.|The dataset for all safety analyses consisted of the data from all enrolled participants who received at least 1 dose of study medication, regardless of any protocol deviation. All observed data for these subjects were included.|||participants|||Number
1397298|NCT01289080|Secondary|Fraction of the Systemically Available Brexpiprazole Metabolite (DM-3411) Excreted Into the Urine (fe,u).|Urine samples were collected at Predose and at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||% of unbound brexpiprazole in urine.||Standard Deviation|Mean
1397339|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 6 months|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants||95% Confidence Interval|Number
1397299|NCT01289080|Secondary|Renal Clearance (CLr) of Brexipiprazole Metabolite (DM-3411).|Urine samples were collected at Predose at intervals of 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, and 144 to 168 hours postdose. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
1397300|NCT01289080|Secondary|Terminal-phase Elimination Half-life of Brexpiprazole (t1/2,z).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. The terminal phase elimination half-life was not determined for DM-3411 metabolite.|||h||Standard Deviation|Mean
1397301|NCT01289080|Secondary|Apparent Unbound Clearance From Plasma After Extravascular Administration of Brexpiprazole (CLu/F).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
1397302|NCT01289080|Secondary|Unbound Fraction of Brexpiprazole in Plasma (fu).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||% of unbound brexpiprazole in plasma||Standard Deviation|Mean
1397303|NCT01289080|Secondary|Apparent Clearance From Plasma After Extravascular Administration of Brexpiprazole (CL/F).|The value of CL/F was determined as Dose/AUC∞. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||mL/h/kg||Standard Deviation|Mean
1397304|NCT01289080|Secondary|Time to Cmax of Brexiprazole Metabolite (DM-3411) (Tmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Tmax is the time taken to reach highest measured concentration of the drug during the dosing interval.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||h||Full Range|Median
1397305|NCT01289080|Secondary|Maximum Plasma Concentration of Brexpiprazole Metabolite (DM-3411) (Cmax).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
1397306|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole From Time Zero to Infinity (AUC∞).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUC∞ was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations. AUC-time curve from zero to infinity (AUC∞) was not determined for DM-3411 metabolite.|||ng*h/mL||Standard Deviation|Mean
1397307|NCT01289080|Secondary|AUC Time Curve of Brexpiprazole Metabolite (DM-3411) Calculated to the Last Observable Concentration at Time t (AUCt).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. The AUCt was estimated using the linear trapezoidal rule.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
1397308|NCT01289080|Primary|Unbound Maximum (Peak) Plasma Concentration of Brexpiprazole (Cmax,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng/mL||Standard Deviation|Mean
1397309|NCT01289080|Primary|Unbound Area Under AUC- Time Curve From Time Zero to Infinity (AUC∞,u).|Blood samples were collected at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours or at ET. Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for PK analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||ng*h/mL||Standard Deviation|Mean
1397310|NCT01289080|Primary|Unbound Area Under the Concentration (AUC) Time Curve Calculated to the Last Observable Concentration Brexpiprazole (AUCt,u).|Blood samples were collected on Day 1 at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours Postdose or at Early Termination (ET). Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.|Day 1 to Day 8|The dataset for pharmacokinetics (PK) analysis of all evaluable brexpiprazole PK parameters consisted of enrolled participants who had evaluable plasma concentrations.|||nanograms*hours/mL (ng*h/mL)||Standard Deviation|Mean
1397315|NCT01289041|Secondary|Overall Survival (OS) According to PI3K Activation Pathway Status|Overall survival (OS) was defined as the time from start of treatment to the date of death due to any cause. If a patient is not known to have died, survival was censored at the last date of contact. OS was to be reported at extension and after 3-year follow-up. The Kaplan-Meier median was used to analyze the OS.|every 3 months|Full analysis set includes all patients who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1397316|NCT01289041|Secondary|Progression Free Survival (PFS) According to PI3K Activation Pathway Status|PFS is defined as the time from start of treatment to the date of first documented progression or death due to any cause. If a patient has not had an event, PFS will be censored at the date of last adequate tumor assessment.|24 months|Full analysis set includes all patients who received at least one dose of study drug.|||months||95% Confidence Interval|Median
1397317|NCT01289041|Primary|Best Overall Response Rate (BORR) According to PI3K Activation Pathway Status|"BOR was determined based on investigator assessment of overall lesion response using RECIST criteria guidelines.~BOR = objective responses rate (ORR), disease control rate (DCR) or clinical benefit rate (CBR). ORR = (complete response (CR) or partial response(PR); DCR = (CR or PR or Stable disease (SD); CBR = (CR or PR od SD >= 24 weeks)"|24 months|Full analysis set includes all patients who received at least one dose of study drug.|||number of participants|||Number
1397318|NCT01289028|Secondary|Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.|Progression-free survival (PFS) is defined as the time from first study drug administration to objective tumor progression or death from any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.|during 12 months||||days||95% Confidence Interval|Median
1397319|NCT01289028|Secondary|Overall Survival, Number of Events Related to Progression of the Disease|The OS rate could not be calculated due to the high number of censored cases. Number of censored, n (%) 108 (86.4). Only available data is number of events. OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died, survival was censored at date of last contact.|during 12 months||||events|||Number
1397320|NCT01289028|Secondary|Duration of Overall Response|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence|during 12 months||||days||95% Confidence Interval|Median
1397321|NCT01289028|Secondary|Time to Tumor Progression|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated as stated in section 9.8.3 of the clinical study report.|during the first 4 months|Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated||||||
1397322|NCT01289028|Secondary|Time to Overall Response (CR or PR): Per Protocol Population|Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks||||percentage of participants|||Number
1397323|NCT01289028|Secondary|Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population|Complete Response (CR): Disappearance of all target lesions. and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|24 weeks and 52 weeks|ITT population|||percentage of participants|||Number
1397324|NCT01289028|Primary|Percent of Patients Achieving Complete Response (CR)|Complete response (CR) is the Disappearance of all target lesions.|during the first 4 months||||percentage of participants|||Number
1397325|NCT01289028|Primary|Percent of Patients Achieving Partial Response (PR)|The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.|during the first 4 months|ITT set, N=125|||percentage of participants|||Number
1397326|NCT01289028|Primary|Percent of Patients Achieving Stable Disease (SD)|Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.|During the first 4 months||||% participants|||Number
1397327|NCT01289015|Secondary|Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6|"Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).~Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture."|Visit 4/ Week 6.|Full Analysis Set (FAS) using a Modified Intent to Treat population.|||percentage of subjects|||Number
1397328|NCT01289015|Primary|Complete Cure of Interdigital Tinea Pedis|"The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis.~Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus."|Visit 4/ Week 6|Full Analysis Set (FAS) defined as the subset of all subjects in the Safety Evaluation Set (SES) with a positive mycology culture at baseline and for whom the primary efficacy variable is available. This was a modified intent to treat principle because culture results were not available before the start of treatment.|||percentage of subjects|||Number
1397329|NCT01288976|Secondary|Six Minute Walk Test Distance (6MWT)|The 6-minute walk distance test will be used to measure the patient's exercise capacity.|12 months|The 6-MWT was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test at the12 month visit.|||meters||Standard Deviation|Mean
1397330|NCT01288976|Secondary|Six Minute Walk Test Distance (6MWT)|The 6-minute walk distance test will be used to measure the patient's exercise capacity.|Baseline|The 6-minute walk test was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test at baseline.|||meters||Standard Deviation|Mean
1397331|NCT01288976|Secondary|Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months|"The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient’s living) to 5(affected the patient’s life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient’s QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL.~The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40)."|12 months|The MLWHF Questionnaire was not consistently administered to patients in the Medical Management&Mitral Valve Surgery groups.Thus MLWHF will not be reported for these comparator arms.Of the 567 MitraClip device patients,264 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&125 patients did not complete MLWHF Questionnaire.|||Quality of Life Score||Standard Deviation|Mean
1397332|NCT01288976|Secondary|The Change in 6 Minute Walk Test Distance From Baseline to 12 Months|The 6 minute walk distance test will be used to measure the patient's exercise capacity. The change in 6 minute walk test distance is calculated as the difference between the distance walked at 12 months and the distanced walked at baseline.|Baseline and 12 months|The 6-minute walk test was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.Thus it will not be reported for these comparator arms.Of the 567 MitraClip device patients,216 analyzed due to death:98,withdrew consent:58,lost to follow-up:22&173 patients did not perform the 6-minute walk test.|||meters||Standard Deviation|Mean
1397333|NCT01288976|Secondary|NYHA Functional Class|"Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity.Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea/anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity.They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea/anginal pain Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken,discomfort is increased."|At 12 month|NYHA Functional Class was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.Of total 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 .|||percentage of participants|||Number
1397334|NCT01288976|Secondary|NYHA Functional Class|"New York Heart Association (NYHA) Functional Classification.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.Less than ordinary physical activity causes fatigue, palpitation dyspnea or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.If any physical activity is undertaken,discomfort is increased."|At baseline|NYHA Functional Class was not consistently captured for patients in the Medical Management&Mitral Valve Surgery groups.NYHA Functional Class will not be reported for these comparator arms.A total of 567 MitraClip patients,343 analyzed due to death:98,withdrew consent:58,lost to follow-up:22,patients had missing NYHA Functional Class assessment:46 .|||percentage of participants|||Number
1397335|NCT01288976|Secondary|Need for Mitral Valve Surgery|This end point is assessed on subjects who underwent mitral valve surgery within 12 months post-MitraClip procedure.|Through 12 months|This outcome measure is reported only for the MitraClip device group. The need for mitral valve surgery was not captured in the Medical Management or the Mitral Valve Surgery groups.|||percentage of participants|||Number
1397336|NCT01288976|Secondary|1-Day Post-Procedure Safety Outcomes|This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups. Because the Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective.Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported.|On day 1 post procedure|1-Day Post-Procedure Safety Outcomes are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups|||percentage of participants|||Number
1397337|NCT01288976|Secondary|Device Embolization and Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~Single leaflet device attachment (SLDA) is defined as the loss of insertion of a single leaflet from the MitraClip device with ongoing insertion of the opposing leaflet. SLDAs are reported on ACCESS-EU adverse event log and MitraClip procedure electronic case report forms, and may also be reported by Abbott Vascular personnel per EU Vigilance requirements."|Through 12 months|Device Embolization and Single Leaflet Device Attachment are reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.|||participants|||Number
1397338|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 12 months|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants||95% Confidence Interval|Number
1397340|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 30 days|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed & studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants||95% Confidence Interval|Number
1397341|NCT01288976|Secondary|Kaplan-Meier Freedom From All-Cause Mortality||At 0 day|Kaplan-Meier freedom from all-cause mortality is not reported for the Medical Management or the Mitral Valve Surgery groups comparator groups. Since they were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants|||Number
1397342|NCT01288976|Secondary|Discharge MR Severity||At discharge, an average of 7.7 days following the MitraClip procedure|"MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups.MR severity will not be reported for these comparator arms.~A total of 521 MitraClip patients analyzed.Missing data is due to death(n=11),patient withdrawal(n=13),data unavailable(n=3),discharge echocardiogram not done/missing(n=19)."|||percentage of participants|||Number
1397343|NCT01288976|Secondary|Discharge Status and Facility||At discharge, an average of 7.7 days following the MitraClip procedure|Discharge Status and Facility is reported only for patients who underwent the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.Discharge Status and Facility outcomes data is available for 563 patients.|||percentage of participants|||Number
1397344|NCT01288976|Secondary|ICU and Hospital Stay|ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure. This secondary outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.|From the day of procedure throughout 12 months of study period|ICU and Hospital Stay is reported only for patients who underwent the MitraClip procedure.The Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||Days||Standard Deviation|Mean
1397345|NCT01288976|Secondary|Number of MitraClip Devices Implanted|Physicians had the option of deploying more than 1 MitraClip device if a single device did not provide satisfactory MR reduction, and if the mitral valve area was large enough to allow multiple MitraClip devices to be placed without causing mitral stenosis.|Day 0 (On the day of procedure)|Number of MitraClip Devices Implanted is reported only for patients who underwent the MitraClip procedure.The Medical Therapy&Mitral Valve Surgery comparator groups were followed&studied primarily from a health economic perspective. Availability of clinical outcomes for the comparator groups is limited, thus it has not been validated and reported.|||percentage of participants|||Number
1397346|NCT01288976|Secondary|Fluoroscopy Duration||Day 0 (On the day of procedure)|"Fluoroscopy duration is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups~Fluoroscopy duration was not recorded for 99 of 567 patients. Therefore, Fluoroscopy duration is available for 468 patients"|||Minutes||Standard Deviation|Mean
1397347|NCT01288976|Secondary|Contrast Volume||Day 0 (On the day of procedure)|"Contrast volume is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.~Contrast volume was not recorded for 9 of 567 patients. Therefore, Contrast volume is available for 558 subjects."|||milliliter||Standard Deviation|Mean
1397348|NCT01288976|Secondary|Procedure Time|Procedure Time is defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter is removed.|Day 0 (On the day of procedure)|"Procedure time is reported only for patients who underwent the MitraClip procedure. This outcome measure does not apply to the Medical Management or the Mitral Valve Surgery groups.~Procedure Time was not recorded for 196 of 567 patients.Therefore, the data is available for 371 patients."|||Minutes||Standard Deviation|Mean
1397349|NCT01288976|Primary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.~MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|At 12 months|MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at 12 months.|||percentage of participants|||Number
1397350|NCT01288976|Primary|MR Severity|"MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.~MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy & Mitral Valve Surgery comparator groups were followed & studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited & has not been validated. Clinical outcomes for the comparator groups will not be reported."|At baseline|MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. MR severity will not be reported for these comparator arms. A total of 240 patients excluded from analysis population due to death:98, withdrew consent:58, lost to follow-up:22 and missed mitral regurgitation evaluation:62 at baseline.|||percentage of participants|||Number
1397477|NCT01287416|Secondary|Suicidal Ideation Since Training at 6 mo Follow-up|Number of people who endorsed having thought about suicide since the training as measured at 6 month follow-up (not at all vs a little to a lot)|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.|||participants|||Number
1397351|NCT01288911|Secondary|Percentage of Participants With Adverse Events|"A serious adverse event was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life threatening~Resulted in persistent or significant disability/incapacity~Resulted in congenital anomaly or birth defect~Required inpatient hospitalization or led to prolongation of hospitalization~Other medically important events.~Treatment-related indicates adverse events assessed by the Investigator as probably or possibly related to study treatment."|From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Safety Analysis Set (all participants who had initiated at least 1 dose of study drug)|||percentage of participants|||Number
1397352|NCT01288911|Secondary|Percentage of Participants With an Objective Response|"Response assessments were reported by ICR for target lesions in soft tissues and non-target lesions in soft tissues based on CT and/or MRI according to RECIST version 1.1.~Objective response was defined as the number of participants achieving either a complete response (CR) or a partial response (PR) based on participant’s best overall response assessed at the end of the treatment."|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||percentage of participants|||Number
1397353|NCT01288911|Secondary|Radiographic PFS Based on ICR Assessment|"Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression.~Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan."|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
1397354|NCT01288911|Secondary|Time to ≥ 90% PSA Decline From Baseline|The time to ≥ 90% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 90% was recorded. In participants without ≥ 90% PSA decline from Baseline, the time to ≥ 90% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
1397355|NCT01288911|Secondary|Time to ≥ 50% PSA Decline From Baseline|The time to ≥ 50% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 50% was recorded. In participants without ≥ 50% PSA decline from Baseline, the time to ≥ 50% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
1397356|NCT01288911|Secondary|Time to ≥ 30% PSA Decline From Baseline|The time to ≥ 30% PSA decline from Baseline was defined as the time interval from the date of randomization to the first date a PSA decline from Baseline of at least 30% was recorded. In participants without ≥ 30% PSA decline from Baseline, the time to ≥ 30% PSA decline from Baseline was censored on the date of the last PSA sample taken. Participants who had no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
1397357|NCT01288911|Secondary|Time to PSA ≤ 4 ng/mL|Time to PSA ≤ 4 ng/mL was defined as the time interval from the date of randomization to the first date a decline in PSA to a result of 4 ng/mL or below was recorded. In participants without PSA results ≤ 4 ng/mL, the time to PSA ≤ 4 ng/mL was censored on the date of the last PSA sample taken. Participants with a PSA result ≤ 4 ng/mL at Baseline, participants with no Baseline PSA and participants with no post-baseline PSA results were censored on the date of randomization|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
1397358|NCT01288911|Secondary|Time to PSA Progression|Time to PSA progression was calculated as the time interval from the date of randomization to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline value for patients who did not have a decline in PSA post-baseline values), and confirmed by a second consecutive PSA assessment at least 3 weeks later. For participants with no documented PSA progression, the time to PSA progression was censored on the date the last PSA sample was taken.|From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
1397359|NCT01288911|Secondary|Best Prostate-specific Antigen (PSA) Response|The best PSA response was defined as the percentage change from Baseline to the smallest PSA value after Baseline including PSA results from samples taken after the study drug was stopped. For participants with no decrease in PSA post-baseline, the best PSA response was the smallest increase in PSA. For participants with no post-baseline PSA values, the PSA response was set to missing. PSA was analyzed at a central laboratory.|Baseline to the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set with available PSA data|||percent change||Full Range|Median
1397370|NCT01288833|Secondary|Cost|"Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis.~A reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured)."|At the time of procedure||||Specimen bottles that could be omitted|||Number
1397360|NCT01288911|Secondary|Prostate-specific Antigen (PSA) Response by Week 13|The PSA response by Week 13 was defined as the percentage change from Baseline to the smallest PSA value after Baseline (i.e., a decrease of 100% represents the largest possible decrease to a value below the lower limit of quantification) and on or before day 99 (i.e., upper boundary of the Week 13 visit window). For participants with no decrease in PSA post-baseline by Week 13, the PSA response by Week 13 was the smallest increase in PSA up to day 99. For participants with no post-baseline PSA values up to day 99, the PSA response by Week 13 was set to missing. PSA was analyzed at a central laboratory.|Baseline to Week 13|Full analysis set with available PSA data|||percent change||Full Range|Median
1397361|NCT01288911|Secondary|PFS Based on Investigator Assessment|"PFS was calculated as the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by investigators, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.~Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.~A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.~The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set|||months||95% Confidence Interval|Median
1397362|NCT01288911|Primary|Progression Free Survival (PFS) Based on Independent Central Review (ICR) Assessment|"PFS is the time from randomization to the date of the first progression event detected. A progression event was defined as objective evidence of radiographic disease progression based on the assessments by the ICR, skeletal-related event, initiation of new antineoplastic therapy or death by any cause, whichever occurred first.~Radiographic disease progression was defined as either a progression in soft tissue on computed tomography (CT)/magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and/or a progression in bone lesions on bone scan (≥ 2 new bone lesions) confirmed by the next bone scan.~A skeletal-related event was any radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression or change in antineoplastic therapy to treat bone pain.~The initiation of new antineoplastic therapy included any new therapy for the treatment of disease progression after the study drug administration started."|From randomization until the data cut-off date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.|Full analysis set (all randomized participants)|||months||95% Confidence Interval|Median
1397363|NCT01288859|Primary|Amount of Total Fecal Polyphenols|Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.|0 and 24 hours post‐dose.||||nmol||Standard Error|Mean
1397364|NCT01288859|Primary|Urinary Excretion of Total Polyphenols|Area Under the Curve (AUC) from 0 to 24h of total polyphenols (sum of parent polyphenols and metabolites)was calculated using a trapezoidal rule applied to the urinary concentration-time curves of compounds.|Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post‐dose.|Basing on power analysis calculation on a previous work|||nmol•h/L||Standard Error|Mean
1397365|NCT01288859|Primary|Serum Polyphenol Concentrations Over 24h From Food Consumption|Area Under the Curves (AUC) from 0 to 24h of parent polyphenols was calculated using a trapezoidal rule applied to the concentration-time curves of compounds.|0, 0.5, 1, 2, 4, 6, and 24 hours post‐dose|The number of subjects was based on power calculations derived from our previous study. We calculated that, at α = 0.05 with a power of 80%, 8 subjects would allow us to detect a 20% difference in serum and urinary concentrations of parental compounds, glucuronides and phenolic acids.|||nmol*h/L||Standard Error|Mean
1397366|NCT01288833|Post-Hoc|Surveillance Colonoscopy Advanced Pathology Findings|Compare the advanced pathology and colon cancer incidence at surveillance colonoscopy of the groups who underwent high definition narrow band imaging colonoscopy with and without close focus features, and more specifically who underwent macroscopic versus microscopic polyp management. This applies if we bring the patient back after 5 years, we have not collected the data yet.|5 to 10 years after colonoscopy|||||||
1397367|NCT01288833|Secondary|Learning Curve|"Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist's first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps."|At time of procedure.|975 total polyps were found and we were able to make high confidence predictions on 774 of them.|||percentage of high confidence prediction|Diminutive polyps|95% Confidence Interval|Number
1397368|NCT01288833|Secondary|Accuracy of Predicted Versus Actual Surveillance Intervals|Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation.|At the time of procedure||||Participants|||Count of Participants
1397369|NCT01288833|Secondary|Diagnostic Characteristics|"Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features.~Accuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps"|At time of procedure|975 total polyps were found with high confidence predictions made on 774 of them.We assessed diagnostic performance of the high confidence predictions. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology.|||percentage of high confidence prediction|Polyps analyzed|95% Confidence Interval|Number
1397371|NCT01288833|Primary|Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups.|Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps.|At the time of procedure|We analyzed all diminutive sized polyps to assess the number of polyps that endoscopists were able to make an accurate high confidence optical diagnosis. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (non-neoplasia) in the NICE classification and no features associated with the other histology.|||Percent of accurate HC predictions|Polyps analyzed|95% Confidence Interval|Number
1397372|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurements. 36 hours is defined at the 36 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 36 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
1397373|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 12 hours is defined at the 12 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 12 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
1397374|NCT01288781|Secondary|Change in Optic Nerve Sheath Diameter|Baseline is defined as the average of the 3 hour 12 hour normoxia measurements. 3 hours is defined at the 3 hour hypoxia measurement.|Optic Nerve Sheath Diameter: baseline, 3 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
1397375|NCT01288781|Secondary|Change in Fluid Balance|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Urine output was recorded by 24 hour urine collection and fluid intake by 24 hour food diaries. Fluid balance was calculated as:~(urine output (L) / fluid intake (L) ) * 100."|Fluid Balance: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||% of fluid intake||Standard Deviation|Mean
1397376|NCT01288781|Secondary|Change in Blood Oxygen Saturation|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement.|Blood Oxygen Saturation: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||% oxygen saturation||Standard Deviation|Mean
1397377|NCT01288781|Secondary|Change in High Altitude Headache by Visual Analogue Scale|Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement. 24 hours is defined at the 24 hour hypoxia measurement. Outcome measured using visual analogue scale, where 0 mm is no headache and 100 mm is maximum headache.|High Altitude Headache: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
1397378|NCT01288781|Primary|Change in Optic Nerve Sheath Diameter by Ultrasonography|"Baseline is defined as the average of the 3 hour and 12 hour normoxia measurement.~24 hours is defined at the 24 hour hypoxia measurement. Optic nerve sheath diameter obtained by ultrasonography of the eye. Increased optic nerve sheath diameter suggests greater intra cranial pressure."|Optic Nerve Sheath Diameter: baseline, 24 hours.|All participants were included. Analysis was intention to treat. There were no missing data.|||mm||Standard Deviation|Mean
1397379|NCT01288729|Primary|Length of Wear of Infusion Site|Comparison of the length of wear (hours) of Sure-T Steel Infusion Set Catheter versus Quick-Set Teflon Catheter. Infusion sets are currently approved for wear 2-3 days (24-72 hours). Participants wore each set for up to 7 days twice. Outcome measure is presented according to the intervention (Steel or Teflon catheter).|5 weeks|Participants with available data were analyzed.|||hours||Inter-Quartile Range|Median
1397380|NCT01288612|Secondary|Acceptability|Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||percentage of participants|||Number
1397381|NCT01288612|Secondary|Mean Tolerability Scores|Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.|Day 1 after the procedure|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||units on a scale||Standard Deviation|Mean
1397382|NCT01288612|Secondary|Mean Time From Extubation to Discharge|This outcome measures the recovery time after the procedure.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||minutes||Standard Deviation|Mean
1397383|NCT01288612|Secondary|Mean Duration of Procedure|Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||minutes||Standard Deviation|Mean
1397384|NCT01288612|Secondary|Rate of Acquisition of Biopsies From the Esophagus||Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||percentage of participants|||Number
1397385|NCT01288612|Secondary|Rate of Complete Evaluation|The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||procedures|||Number
1397386|NCT01288612|Secondary|Rate of Successful Intubation|The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.|Visit 1|The analysis population included all subjects who agreed to undergo the esophageal assessment (intent to treat).|||percentage of participants|||Number
1397387|NCT01288612|Primary|Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment|This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.|Approximately 2 weeks after invitation letter was sent|The analysis population for this outcome measure was the number of subjects per group who were eligible to contact.|||percentage of participants|||Number
1397388|NCT01288534|Secondary|Frequency of Required Interventions.|To assess the frequency of required interventions (interruptions) based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions.|5 years||||percentage of participants|||Number
1397389|NCT01288534|Secondary|Relation Between Reconstructed Delivered Dose Distributions.|To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.|5 years|Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed||||||
1397390|NCT01288534|Secondary|Relation Between Dose Distribution and Toxicities.|To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses.|5 years|Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed.||||||
1397391|NCT01288534|Secondary|Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months|To estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion.|1 Year||||percentage of patients|||Number
1397392|NCT01288534|Primary|Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)|"To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks.~Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months."|24 months||||percentage of patients|||Number
1397393|NCT01288521|Primary|Tacrolimus Bioavailability (F)|Tac bioavailability alone vs. Tac bioavailability with Keto. To determine F we took the ratio of area under the curve of the oral dose divided by the area under the curve of the IV dose. F was determined by fitting a model that considered the plasma concentration of tac with IV vs. oral dosing.|baseline and 2 weeks|Stable kidney transplant recipients|||ratio of oral to IV||Standard Deviation|Mean
1397394|NCT01288469|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameter analyzed|||ratio||Inter-Quartile Range|Median
1397395|NCT01288469|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment HDL-C value.|||percent change||Standard Error|Least Squares Mean
1397396|NCT01288469|Secondary|Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).|From baseline to Week 8 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.|||percent change||Inter-Quartile Range|Median
1397397|NCT01288469|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis||Week 8 (LOCF)|mITT population.|||percentage of participants|||Number
1397398|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.|||mg/dL||Standard Error|Least Squares Mean
1397399|NCT01288469|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From baseline to Week 8 (LOCF)|mITT population.|||mmol/L||Standard Error|Least Squares Mean
1397400|NCT01288469|Primary|Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 8 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 8 (LOCF)|Modified Intent-To-Treat (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
1397401|NCT01288443|Secondary|Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for ApoB/ApoA-1 ratio analyzed.|||ratio||Standard Error|Least Squares Mean
1397586|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.|Week 48|Full Analysis Set|||percentage of participants|||Number
1397402|NCT01288443|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.|||percent change||Inter-Quartile Range|Median
1397403|NCT01288443|Secondary|Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies the number of participants analysed for each lipid parameter.|||percent change||Standard Error|Least Squares Mean
1397404|NCT01288443|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.|||percentage of participants|||Number
1397405|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mg/dL||Standard Error|Least Squares Mean
1397406|NCT01288443|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mmol/L||Standard Error|Least Squares Mean
1397407|NCT01288443|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first study drug injection up to 21 days after last study drug injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1397408|NCT01288287|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks|HAQ-DI is a questionnaire which measures function and health-related quality of life. The final score range is 0-3, with higher scores denoting greater disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline to 78 weeks.|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||units on a scale||Standard Deviation|Mean
1397409|NCT01288287|Secondary|Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks|"RADAI is a five-item questionnaire administered to patients. The final score range is 0-10, with higher scores denoting a worse disease state.~A negative value in RADAI change from Baseline indicates an improvement from Baseline to 78 weeks."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||units on a scale||Standard Deviation|Mean
1397410|NCT01288287|Secondary|Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline|"Percentage of patients achieving good, moderate, or no EULAR clinical response, where good response is defined as DAS28(ESR) ≤ 3.2 and decrease from baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(ESR) ≤ 3.2 and decrease from baseline > 0.6 and ≤ 1.2,~DAS28(ESR) > 3.2 and ≤ 5.1 and decrease from baseline > 0.6,~DAS28(ESR) > 5.1 and decrease from baseline > 1.2 Patients without a good or moderate response are considered to be non-responders."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||percentage of patients|||Number
1397411|NCT01288287|Secondary|Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:~DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.~DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||units on a scale||Standard Deviation|Mean
1397412|NCT01288287|Primary|Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points|"DAS28(ESR) is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), ESR (mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm). 28 joints are examined using:~DAS28(ESR) = 0.56 * √(TJC) + 0.28* √(SJC) + 0.70* ln(ESR) + 0.014* PtGADA, with TJC=0 to 28, SJC=0 to 28, PtGADA=0 to 100 mm, ESR=0 to infinite mm/hour but ESR values of greater 250 mm/h are typically measurement errors.~DAS28(ESR) ranges from 0 to around 10 with lower scores indicating less disease activity."|Baseline (Week 0), 78 weeks|Full Analysis Set (FAS) consists of all patients entered into the study who take at least one dose of Certolizumab Pegol and have a valid, non-missing complete DAS28(ESR) score at Baseline and Week 12 (+/- 2 weeks).|||percentage of patients||95% Confidence Interval|Number
1397587|NCT01286740|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set|||percentage of participants|||Number
1397413|NCT01288209|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|"The table below shows the median (range) AUC24h values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of “Overall” represents the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng.h/mL||Full Range|Median
1397414|NCT01288209|Secondary|Plasma Concentrations of TMC435|"The table below shows median (range) TMC435 predose plasma concentration (C0h) values and TMC435 maximum plasma concentration (Cmax) values for participants in each treatment group at Week 12, Week 24, and Overall (Weeks 4, 12, and 24). The time frame of “Overall” representes the median exposure estimate using all available data collected at Weeks 4, 12, and 24 for each participant in the study. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed."|Week 12, Week 24, and Overall (Weeks 4, 12, and 24)|Pharmacokinetic analysis was performed in the pharmacokinetic (PK) population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
1397415|NCT01288209|Secondary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFNα-2a) and Ribavirin (RBV) at Week 24|The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2a and RBV at Week 24. Participants in the TMC435 treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48.|Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397416|NCT01288209|Secondary|The Number Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants in each treatment group with abnormal ALT levels at baseline (Day 1) who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at the EOT. At Baseline, 34/53 participants in the TMC435 100 mg 12 Wks PR 24/48 treatment group and 35/53 participants in the TMC435 100 mg 24 Wks PR 24/48 treatment group had abnormal ALT levels.|EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1397417|NCT01288209|Secondary|The Number of Participants Demonstrating Viral Relapse During the Study|The table below shows the number of participants in each treatment group who demonstrated viral relapse during the study. Viral relapse is defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at EOT and detectable HCV RNA during follow-up or detectable HCV RNA at the time points for a sustained viral response (SVR) assessment. The incidence of viral relapse was only calculated for participants with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement.|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1397418|NCT01288209|Secondary|The Number of Participants With Viral Breakthrough During the Study|The table below shows the number of all participants in each treatment group who experienced viral breakthrough during the treatment period in the study (Baseline to end of treatment [EOT], ie, Week 24 or 48). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in all participants whose plasma HCV RNA level had previously been below 1.2 log10 IU/mL detectable or undetectable.|Up to EOT (Week 24 or 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
1397419|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During Treatment for Participants Who Did Not Achieve Undetectable Plasma HCV RNA Levels at Week 12|"The table below shows the percentage of participants with undetectable HCV RNA at Weeks 24, 48, end of treatment (EOT), at the time of assessment for a sustained virologic response (SVR) 12 weeks after the last planned dose (SVR12) (Week 36 or 60), and SVR24 (Week 48 or 72) who did not achieve undetectable HCV RNA levels at Week 12. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x) if different from the “Number of Participants Analyzed. Results are not available for Weeks 24, 48, and EOT because there were no participants who met the criteria for a SVR at those time points."|Weeks 24, 48, EOT (Weeks 24 or 48), SVR12 (Weeks 36 or 60), and SVR24 (Weeks 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397432|NCT01288027|Primary|Change From Baseline in Tissue Glycogen Content in Quadriceps Muscle Biopsy Samples at Week 26|Tissue glycogen content was measured by quadriceps biopsies as ‘percent area of tissue occupied by glycogen'.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, n = number of participants with both Baseline and Week 26 assessment of tissue glycogen content.|||percent area occupied by glycogen||Standard Deviation|Mean
1397420|NCT01288209|Secondary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)|The table below shows the percentage of participants with undetectable HCV RNA (<1.2 log10 IU/mL) during treatment at Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (Week 24 or 48).|Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397421|NCT01288209|Secondary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group with a greater than (>) or equal to (=) 2 log10 IU/mL drop from baseline in HCV RNA at each time point during treatment and post-treatment follow-up.|Day 3, Day 7, and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and Follow-up (FU) Weeks 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397422|NCT01288209|Secondary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)|The table below shows the observed percentage of participants in each treatment group with a SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 24 weeks after the last dose of treatment (Week 48 or 72).|EOT (Week 24 or 48) and Week 48 or 72|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397423|NCT01288209|Primary|The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)|The table below shows the observed percentage of participants in each treatment group with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at the EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).|EOT (Week 24 or 48) and Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
1397424|NCT01288079|Primary|Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment|A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214, duloxetine or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1397425|NCT01288053|Primary|Survival|The number of participants who survived treatment|Up to five years|The number of participants who survived treatment|||participants|||Number
1397426|NCT01288027|Secondary|Percent Change From Baseline in Disease Activity Using T2 Magnetic Resonance Imaging (MRI) at Week 26|Disease activity (inflammation and/or water content within muscles) was quantitatively assessed by T2 MRI values in a subset of participants. A T2 MRI value of greater than (>) 39 millisecond (ms) was defined as abnormal. T2 estimation normally requires an additional acquisition for computing the B1 spatial deviation however, can still be estimated if this acquisition is missing.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here Number of participants analyzed = number of participants with both baseline and Week 26 assessment of disease activity.|||percent change||Standard Deviation|Mean
1397427|NCT01288027|Secondary|Percent Change From Baseline in Degree of Fatty Infiltration Using 3-Point 3-Dimensional (3D) Dixon at Week 26|Degree of Fatty Infiltration was assessed by 3-point 3D Dixon acquisition using skeletal muscle MRI in a subset of participants.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, number of participants analyzed = number of participants with both Baseline and Week 26 assessment of degree of fatty infiltration.|||percent change||Standard Deviation|Mean
1397428|NCT01288027|Secondary|Percent Change From Baseline in Muscle Involvement Using Mercuri Scoring at Week 26|Muscle involvement was assessed by T1-weighted magnetic resonance imaging (MRI). T1-weighted MRI data was analyzed using the Mercuri scoring in both legs (Total score = 1-4; where 1=Normal appearance, 2=Mild involvement, 3=Moderate involvement, and 4=Severe involvement). For each participants, the average for each the upper (thigh) and lower leg was computed for Mercuri grading.|Baseline, Week 26|FAS population included all participants who received at least one complete infusion of alglucosidase alfa. Here, Number of participants analyzed= participants with both Baseline and Week 26 assessment of muscle involvement, n= number of participants with both Baseline and Week 26 assessment of muscle involvement for specified category.|||percent change||Standard Deviation|Mean
1397429|NCT01288027|Secondary|Lysosomal Inclusions||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.||||||
1397430|NCT01288027|Secondary|Muscle Fiber Morphology||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.||||||
1397431|NCT01288027|Secondary|Glycogen Distribution||Baseline, Week 26|No quantitative data could be reported for this outcome as the assessment was qualitative in nature.||||||
1397478|NCT01287416|Secondary|Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training|Number of people who endorsed having thought about suicide in the past 2 days as measured immediately post training (not at all vs a little to a lot)|July 22-23, 2010|The smaller number of participants per group reflects the number of individuals who responded to the post-training questionnaire.|||participants|||Number
1397433|NCT01287897|Secondary|Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."|||participants|||Number
1397434|NCT01287897|Secondary|Serum PF-04236921 Concentration Over Time||Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40|"The pharmacokinetic (PK) analysis set was the subset of participants from the SAS who provided at least 1 PK concentration (2 participants [10 mg arm] excluded due to a quality issue). n is the number of participants with PK data at the visit. From Weeks 16 to 40, only participants who remained in the follow-up period of this study were analyzed."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1397435|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)|The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."|||percentage of participants|||Number
1397436|NCT01287897|Secondary|Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)|The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32.|At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40|"The SAS consisted of all participants who received at least 1 dose of study drug. n signifies number of participants with observed data at the time point of each arm. From Weeks 16 to 40, only participants who remained in the follow-up period of this study and did not enter NCT01405196 were analyzed."|||percentage of participants|||Number
1397437|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||points on a scale||90% Confidence Interval|Least Squares Mean
1397438|NCT01287897|Secondary|Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||points on a scale||90% Confidence Interval|Least Squares Mean
1397439|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397454|NCT01287754|Secondary|Number of Erlotinib-Treated Participants With the EGFR Mutation With an Objective Response Per RECIST v1.1|Objective tumor response was assessed by the investigator using RECIST v1.1 and recorded as complete response (CR), partial response (PR), or unmeasurable. RECIST v1.1 defines CR as disappearance of all target lesions, with short-axis reduction to less than (<) 10 mm for any pathological lymph nodes, and PR as a 30% or greater reduction from baseline in the sum of diameters of target lesions.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated|||participants|||Number
1397479|NCT01287416|Secondary|Suicidal Ideation in Past 2 Days at Baseline|Number of people who endorsed having thought about suicide in the past 2 days as measured at baseline (not at all vs a little to a lot)|July 19-20, 2010||||participants|||Number
1397440|NCT01287897|Secondary|The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397441|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397442|NCT01287897|Secondary|The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, 8, 10, and 12|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397443|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 participants. n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397444|NCT01287897|Secondary|The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Weeks 2, 4, 6, and 10|"The analysis was performed on the FAS excluding 200 mg arm (which was halted prematurely). n signifies the number of subjects with observed data of each arm at each time point."|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397455|NCT01287754|Primary|Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation|PFS was defined as the time from the first dose of erlotinib to the first documentation of disease progression or death, whichever occurred first. Tumor progression was determined using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which defines progression as a 20 percent (%) or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm), or the appearance of one or more new lesions. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Treated: All participants who received at least one dose of erlotinib were included in the analysis.|||months||95% Confidence Interval|Median
1397480|NCT01287416|Secondary|Lifetime Suicide Attempt at Baseline|Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline|July 19-20, 2010||||participants|||Number
1397445|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.|Baseline and Week 12|The analysis was performed on FAS 200 mg vs placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397446|NCT01287897|Primary|The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 12|Primary analysis: FAS excluding 200 mg arm (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397447|NCT01287897|Primary|The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.|Baseline and Week 8|The analysis was performed on FAS participants of the 200 mg and placebo arms, referred to as FAS 200 mg versus (vs) placebo. The 200 mg arm was halted before reaching the planned sample size of approximately 60 and was no longer powered at the planned level to test against placebo. Thus, the 200 mg vs placebo comparison is a sensitivity analysis.|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397448|NCT01287897|Primary|The Crohn’s Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg|CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).|Baseline and Week 8|Primary analysis: full analysis set (FAS, defined as all randomized participants who received at least 1 dose of study treatment; 2 participants [10 mg arm] excluded due to a quality issue) excluding 200 mg (halted prematurely before reaching the planned sample size and thus no longer powered at the planned level to test against placebo).|||Percentage of participants||90% Confidence Interval|Least Squares Mean
1397449|NCT01287832|Secondary|Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity||30-42 days post-treatment|||||||
1397450|NCT01287832|Primary|Number of Participants With Clinical Success at Test of Cure Visit.|Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.|30-42 days post-treatment||||participants|||Number
1397451|NCT01287754|Secondary|Percentage of Participants With EGFR Mutation at Screening|Participants were tested at Screening for the presence of activating mutations in the tyrosine kinase domain of EGFR. The percentage of participants with mutation was calculated as [number of mutation-positive participants divided by number tested] multiplied by 100.|Screening|All Participants Enrolled|||percentage of participants||95% Confidence Interval|Number
1397452|NCT01287754|Secondary|Percentage of Participants Alive at 6 and 12 Months|Death from any cause was documented at 6 and 12 months from recorded diagnosis. The percentage of participants alive at each timepoint was calculated as [number of participants alive divided by number enrolled] multiplied by 100.|At 6 and 12 months|All Participants Enrolled|||percentage of participants|||Number
1397453|NCT01287754|Secondary|Overall Survival (OS) Among Erlotinib-Treated and Untreated Participants|OS was defined as the time from recorded diagnosis to death from any cause or last patient last visit. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|Per standard of care (every 3 months) until discontinuation for up to approximately 2 years|All Participants Enrolled: All erlotinib-treated participants who received at least one dose of erlotinib, in addition to all enrolled untreated participants, were included in the analysis.|||months||95% Confidence Interval|Median
1397456|NCT01287741|Secondary|Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)|Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.|C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)|40 Japanese participants in the Obinutuzumab+Chemotherapy arm|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1397457|NCT01287741|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores|The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.|Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days)|The intent-to-treat (ITT) population included all randomized participants.|||score on a scale||Standard Deviation|Mean
1397458|NCT01287741|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score|The FACT-Lym subscale was developed to assess health-related quality of life in patients with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.|Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 4 years and 9 months, (cycle length = 21 days)|The intent-to-treat (ITT) population included all randomized participants.|||score on a scale||Standard Deviation|Mean
1397459|NCT01287741|Secondary|Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab|The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.|Pre-dose (Hour 0) on Cycle (C) 1 Day (D) 1, C4D1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)|The safety analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
1397460|NCT01287741|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The safety analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
1397461|NCT01287741|Secondary|Time to Next Anti-Lymphoma Treatment (TTNALT)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.|Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
1397462|NCT01287741|Secondary|Duration of Response (DOR), Investigator-Assessed|DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%.|Baseline up to death or disease progression, whichever occurs first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis.|||months||95% Confidence Interval|Median
1397463|NCT01287741|Secondary|Disease-Free Survival (DFS), Investigator-Assessed|Disease-free survival was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/relapse or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|Baseline up to death or disease progression, whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants, of which evaluable participants were included in this analysis.|||percentage of participants|||Number
1397475|NCT01287416|Secondary|Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts|Number of participants who have asked someone that they thought was at risk about suicidal thoughts since the training, measured at 6 month follow-up assessment.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||participants|||Number
1397476|NCT01287416|Secondary|Attempted Suicide Since Training at 6 mo Follow-up|Number of people who endorsed having made a suicide attempt since the training as measured at 6 month follow-up|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the 6 month follow up time point questionnaire.|||participants|||Number
1397481|NCT01287416|Secondary|Lifetime Suicidal Ideation at Baseline|Number of people who endorsed having thought about suicide in their lifetime as measured at baseline|July 19-20, 2010||||participants|||Number
1397464|NCT01287741|Secondary|Event-Free Survival (EFS), Investigator-Assessed|Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non–protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.|Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397465|NCT01287741|Secondary|Complete Response (CR) at the End of Treatment, IRC-Assessed|Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397466|NCT01287741|Secondary|Complete Response (CR) at the End of Treatment, Investigator-Assessed|Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397467|NCT01287741|Secondary|Overall Response Rate (ORR), IRC-Assessed|Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397468|NCT01287741|Secondary|Overall Response Rate (ORR), Investigator-Assessed|Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397469|NCT01287741|Secondary|Overall Survival (OS)|Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397470|NCT01287741|Secondary|Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed|Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397471|NCT01287741|Primary|Progression-Free Survival (PFS), Investigator-Assessed|Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to data cut-off (up to approximately 4 years and 9 months)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
1397472|NCT01287611|Secondary|Length of Uterine Incision After Suturing|Length of uterine incision after suturing will be examined and measured by ultrasonography, and two groups will be compared.|6 weeks after C/S||||cm||Standard Deviation|Mean
1397473|NCT01287611|Primary|Cesarean Scar Defect in the Uterine Incisional Line|A wedge-shaped distortion in the integrity of the uterine incision scar during transvaginal ultrasonographic examination at 6 weeks after C/S was accepted as cesarean scar defect in the uterine incisional line and recorded as primary outcome measure, and two groups will be compared.|6 weeks after C/S||||participants|||Number
1397474|NCT01287416|Secondary|Gatekeeper Behaviours - Did Not Ask Person at Risk|Number of participants who did not ask someone about their suicidal thoughts even though they thought they were at risk, measured at 6 month follow-up assessment based on time since training.|January 28-31, 2011|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||participants|||Number
1397482|NCT01287416|Secondary|Self-reported Resiliency Score|Assesses resiliency in the participant according to the Connor-Davidson Resilience Scale, 10-item. The CD-RISC 10 is comprised of ten questions scored from 0 (Not at all true) to 4 (True nearly all of the time). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (low resiliency) to 40 (highly resilient).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||Scores on scale||Standard Error|Mean
1397483|NCT01287416|Secondary|Self-reported Alcohol Use|Details participants' level of alcohol consumption and if it may be harmful according to the AUDIT. The AUDIT scale is comprised of ten questions with most questions being scored from 0 (never) to 4 (4 or more times per week). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (no risk related to alcohol) to 40 (high risk related to alcohol). Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||Scores on a scale||Standard Error|Mean
1397484|NCT01287416|Secondary|Self-reported Distress|Measures the level of distress in the participant using the K6 distress scale. The scale is comprised of six questions which are scored from 0 (none of the time) to 4 (all of the time). The sum of the scores from all six questions was used to determine a total scale score which ranges from 0 (not at all distressed) to 24 (very distressed).|pre-training and 6 month follow-up|The smaller number of participants per group reflects the number of individuals who responded to the baseline and 6 month follow up time point questionnaires.|||Scores on a scale||Standard Error|Mean
1397485|NCT01287416|Secondary|Self-perceived Preparedness|Measures the level of preparedness of the individual to help someone who is suicidal based on a 4 point Likert scale ranging from 1 (not at all prepared) to 4 (very prepared).|pre-training, post-training and 6 month follow-up||||Scores on a scale||Standard Deviation|Mean
1397486|NCT01287416|Secondary|Self-perceived Knowledge About Suicide|Measures the level of knowledge about suicide that the individual believes they have based on a 4 point Likert scale ranging from 1 (not at all knowledgeable) to 4 (very knowledgeable).|pre-training, post-training and 6 month follow-up||||Scores on a scale||Standard Deviation|Mean
1397487|NCT01287416|Secondary|Self-perceived Skill in Helping a Suicidal Individual|Measures the level of ability that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all skilled) to 4 (very skilled).|pre-training, post-training and 6 month follow-up||||scores on a scale||Standard Deviation|Mean
1397488|NCT01287416|Secondary|Self-perceived Confidence in Helping a Suicidal Individual|Meaures the level of confidence that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all confident) to 4 (very confident).|pre-training, post-training and 6 month follow-up||||scores on a scale||Standard Deviation|Mean
1397489|NCT01287416|Primary|SIRI Questionnaire Score|The Suicide Intervention Response Inventory (SIRI-2) will be used to detect enhancement of intervention skills in participants. The 25-item SIRI-2 is a self-administered test that was designed to measure competnce in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI-2 has shown its good psychometric properties, freedom from social desirabiity effects and responsiveness to training in suicide prevention.|pre-training, post-training and 6 mo follow up||||number of items correct||Standard Deviation|Mean
1397490|NCT01287403|Secondary|Phenolic Acids|Phenolic acids in plasma and urine|0-48 h post dose|||||||
1397491|NCT01287403|Secondary|Plasma and Urinary Betaine||From 0 to 48 hours post dose|||||||
1397492|NCT01287403|Primary|Plasma Alkylresorcinol Compounds|Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake.|From 0 to 48 h post dose.||||nmol/L*h||Standard Deviation|Mean
1397493|NCT01287364|Primary|Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales|Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables “correlates” with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors.|Day 1 (Pre-treatment) through Day 29|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.|||factor loadings|||Number
1397494|NCT01287364|Primary|Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)|"Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are “small”(0.2), “medium” (0.5), and “large” (0.8).~Between group SES indicates the magnitude of “treatment” differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)."|Day 1 (Pre-treatment) through Day 29|Baseline rTNSS was partitioned into tertiles and patients were assigned to Low, Medium, or High symptom groups.|||standard effect sizes|||Number
1397502|NCT01287221|Secondary|Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II)|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
1397495|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of “no change” (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (pre-treatment) through Day 7 Treatment Period 2|The rTNSS total period 2 change scores were partitioned into tertile ranges to form three groups: Low Change (-0.70 – -1.85; n = 55), Medium Change (-2.08 – -1.74; n = 56), or High Change (-6.57 – -2.14; n = 55).|||scores on a scale||Standard Error|Mean
1397496|NCT01287364|Primary|Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)|Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of “no change” (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (pre-treatment) through Day 7 Treatment Period 1|The rTNSS total period 1 change scores were partitioned into tertile ranges to form three groups: Low Change (-1.04 – -4.93; n = 60), Medium Change (-2.49 – -1.05; n = 62), and High Change (-7.57 – -2.50; n = 61).|||scores on a scale||Standard Error|Mean
1397497|NCT01287364|Primary|Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)|Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 – 7.17; n = 62), Medium Symptoms (7.25 – 9.25; n = 61), or High Symptoms (9.33 – 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction).|Day 1 (Pre-treatment) through Day 7 Treatment Period 1|Baseline rTNSS was partitioned into tertile ranges and patients were assigned to Low (3.00 – 7.17; n = 62), Medium (7.25 – 9.25; n = 61), or High (9.33 – 12.00; n = 62) symptom groups.|||scores on a scale||Standard Error|Mean
1397498|NCT01287364|Primary|Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics|Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses [Cronbach’s alpha (raw and standardized) coefficients were calculated]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.|Day 1 (Pre-treatment) through Day 7 Treatment Period 2|Subjects from Treatment Sequence AB (ciclesonide nasal aerosol 74 mcg/mometasone nasal spray 200 mcg) and Treatment Sequence BA (mometasone nasal spray 200 mcg/ciclesonide nasal aerosol 74 mcg) were pooled. Validation was performed without regard to treatment, thus all observations were pooled.|||ratio of variance|||Number
1397499|NCT01287221|Secondary|Change in the COMPASS-Select-Change Scale From Baseline to 12 Months|"The change in COMPASS is a derivative of COMPASS and evaluates the change in symptoms over time on selected domains of symptoms as a function of natural history or intervention therapy. The focus is on 7 selected domains. The version of the COMPASS-Change -Select Scale used (06-09-2009 Ver. 1) has 16 questions, with multiple parts, scores ranging from much worse to no such symptoms. The score could range from 0 (no such symptoms) to 94 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
1397500|NCT01287221|Secondary|Change From Baseline to 12 Months in the COMPASS-Select Scale|"The composite autonomic symptoms score (COMPASS) provides a score of autonomic symptom severity with appropriate weighting. In the COMPASS_select, symptoms are confined to 6 select domains of symptoms. The version of the COMPASS-Select used (06-09-2009 v1) has 46 questions, with multiple parts, scores ranging from much worse to no such symptoms. Scores could range from 0 (no such symptoms) to 85 (much worse)."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
1397501|NCT01287221|Secondary|Rate of Change From Baseline to 12 Months in Total UMSARS (i.e., UMSARS Part I Minus Question 11 + UMSARS Part II) Using Slope Estimate|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for total UMSARS Parts I minus Question 11 + Part II could range from 0 (normal) to 104 (extreme dysfunction).~Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their total UMSARS scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale per month||Standard Deviation|Mean
1397503|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part II|UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part II has 14 items with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part II could range from 0 (normal) to 56 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
1397504|NCT01287221|Secondary|Change From Baseline to 12 Months in UMSARS Part I Score (Minus Question 11)|UMSARS is a scale measuring disease progression that comprises 4 parts, only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).|baseline, 12 months|Analysis was done using intention to treat principles. Not all patients reached the 12 month time point due to missed visits or the early termination of the study.|||units on a scale||Standard Deviation|Mean
1397505|NCT01287221|Primary|Rate of Change From Baseline to 12 Months in the Total Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Score (Minus Question 11)|"UMSARS is a scale measuring disease progression that comprises 4 parts; only Parts I and II were used in this study. Part I scores symptoms of neurological and autonomic dysfunction. Part II is a motor examination. Part I has 12 questions with a rating scale ranging from 0 (normal) to 4 (extreme dysfunction). Therefore the total score for Part I could range from 0 (normal) to 48 (extreme dysfunction).~Participant-specific rate of change in points per month was estimated using slope estimate from least square regression where for each participant, their UMSARS I scores were plotted over time measured in months."|baseline, 12 months|Analysis was done using intention to treat principles and no imputations were done for any missing values or slope estimates. All randomized participants who took at least two doses of the study drug were included in the principal efficacy analysis. One subject on the Rifampicin arm did not return after the baseline visit.|||units on a scale per month||Standard Deviation|Mean
1397506|NCT01287208|Secondary|Hours of Sleep Per Night|"Number of hours slept per night as recorded on activity device.~This secondary outcome was not measured in the trial."|12 weeks|This outcome was not collected because of logistical issues with obtaining this data without using an API.||||||
1397507|NCT01287208|Secondary|Weight||6 months||||Pounds||Standard Deviation|Mean
1397508|NCT01287208|Secondary|Calories Burned Per Day|Total calories burned per day recorded on activity device. This secondary outcome was not measured in the trial.|12 weeks|This outcome was not collected because of logistical issues with obtaining this data without using an API.||||||
1397509|NCT01287208|Secondary|Distance Per Day|Distance in miles recorded on activity device.|12 weeks|This outcome was not collected because of logistical issues with obtaining this data without using an API.||||||
1397510|NCT01287208|Primary|Steps Per Day|Steps will be recorded on the activity device|12 weeks|We excluded 4 participants who withdrew prior to randomization and 5 who withdrew after randomization.|||steps per day||Inter-Quartile Range|Median
1397511|NCT01287195|Secondary|Score in Histologic Evaluation of Flexible Sigmoidoscopy|Mucosal biopsies were obtained from the most inflamed area seen during flexible sigmoidoscopy and blindly scored by a single pathologist with scores ranging 0-3 with a higher score indicating a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.|||score on a scale||Standard Error|Mean
1397512|NCT01287195|Secondary|Simple Clinical Colitis Activity Index (SCCAI) Score|SCCAI is a symptom based questionnaire addressing five assessments, including bowel frequency day, bowel frequency night, urgency of defecation, blood in stool and general well-being. Score ranges from 0-15 with one additional point added for each manifestation of extracolonic features. A higher score indicates a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.|||score on a scale||Standard Error|Mean
1397513|NCT01287195|Secondary|Mayo Score|The Mayo Score is determined by the investigator by assigning a score to the following four assessments: stool frequency, rectal bleeding, physician’s global assessment and endoscopy. Total range for Mayo score is 0-12 with a higher score indicating a worse outcome.|Baseline, Week 5|All participants enrolled in the study for whom data were available at each time point.|||score on a scale||Standard Error|Mean
1397514|NCT01287195|Primary|Cytokine Production by PBMCs in Cell Culture|Cytokine production was assessed in cell cultures of PBMCs obtained from participants at baseline, Weeks 1, 3 and 5. The following cytokines were detected and are reported here: interferon gamma (IFN-gamma), interleukin (IL)-17A, IL-6, IL-1 beta, tumor necrosis factor (TNF) and IL-10.|Baseline, Weeks 1, 3 and 5|All participants enrolled in the study for whom data were available at each time point.|||picograms/milliliter (pg/mL)||Standard Deviation|Mean
1397515|NCT01287195|Primary|T Cell Proliferation of PBMCs in Cell Culture|PBMCs isolated from whole blood obtained from participants at baseline, Weeks 1, 3, and 5 were assessed for proliferation in cell culture using a radioactive thymidine incorporation assay. A higher number indicates a higher level of proliferation.|Baseline, Weeks 1, 3 and 5|All participants enrolled in the study for whom data were available at each time point.|||radioactive counts of cells per minute||Standard Error|Mean
1397516|NCT01287195|Primary|Percentage of Biomarker-positive Immune Cells|Peripheral blood mononuclear cells were (PBMCs) were isolated from blood samples taken from each participant at baseline and Week 5. PBMCs were stained with a panel of fluorochrome-conjugated antibodies against multiple surface and intracellular biomarkers, including Cluster of Differentiation (CD) 3, CD4, CD8, Forkhead box P3 protein (FOXP3) and latency-associated peptide (LAP). The percentage of T cells positive for each of these biomarkers was determined by fluorescence activated cell sorting (FACS) and the mean percentage of positive T cells for each biomarker for all analyzed participants is reported.|Baseline, Week 5|All participants enrolled in the study for whom data were available at both time points.|||percentage of biomarker-positive T cells||Standard Deviation|Mean
1397517|NCT01287195|Primary|Number of Participants With Anti-Drug Antibodies|Serum samples were obtained to measure anti-drug antibodies during the study.|From baseline to Week 10|All participants enrolled in the study.|||Participants|||Count of Participants
1397518|NCT01287195|Primary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From baseline to Week 10|All participants enrolled in the study.|||Participants|||Count of Participants
1397519|NCT01287117|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
1397520|NCT01287117|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded “No” to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage||Standard Deviation|Mean
1397521|NCT01287117|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1397522|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1397523|NCT01287117|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
1397524|NCT01287117|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
1397525|NCT01287117|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Weeks||95% Confidence Interval|Median
1397526|NCT01287117|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1397527|NCT01287117|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1397528|NCT01287117|Primary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1397529|NCT01287065|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN) and total bilirubin >=2 x ULN or international normalised ratio >1.5. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the first dose of the study medication until the Follow-up Visit (up to 18 weeks)|All Subjects Population: all participants who received at least one dose of the study medication.|||Participants|||Number
1397530|NCT01287065|Secondary|AM and PM Pre-treatment Trough FEV1 on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Trough FEV1 is defined as pre-dose (AM and PM) FEV1 measurement taken on Day 14. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant baseline, period baseline, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=23).|Day 14|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1397531|NCT01287065|Secondary|Pre-treatment PEF (AM and PM) on Days 1-12.|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 2 to 12 was analyzed. The analysis was performed using a mixed effect analysis of covariance model with fixed effect terms for treatment and period; baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect. Participant 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=26). Participant 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=24).|From Day 2 up to Day 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||95% Confidence Interval|Least Squares Mean
1397532|NCT01287065|Primary|Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0–24 Hours Post-dose on Day 14|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry at Day 14. Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at the following time points: pre-dose (Day 14 evening dose), and 3, 6, 9, 12, 15, 18, 21 and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; and participant (par.) baseline, period baseline, gender and age fitted as covariates; and par. as a random effect. Par. 122 received FF/VI 100/25 PM in treatment periods 1 and 3 and contributed twice to the summary of FF/VI 100/25 PM (n=25). Par. 123 received Placebo in treatment periods 2 and 3 and contributed twice to the summary of Placebo (n=20).|Pre-dose on Day 14 to 24 hours post-dose|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication and provided at least one post-dose peak expiratory flow (PEF) or FEV1 measurement. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1397533|NCT01287039|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|The immunogenicity of reslizumab was assessed by measuring for the presence of anti-reslizumab antibodies at baseline, weeks 16, 32, 48, and 52 or early withdrawal. Blood samples for anti-reslizumab antibodies assessment were also obtained from all patients (inside or outside of the US) experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.|Weeks 16, 32, 48 and 52|Safety analysis set. Immunogenicity for anti-reslizumab antibodies not reported for the placebo treatment arm.|||participants|||Number
1397534|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse - high 12-17 yr: >100 and increase of >= 30 beats/minute (bpm)~Sitting pulse - low >=18 yr: <50 and decrease of >=30 bpm~Sitting pulse - high >=18 yr: >100 and increase of >=30 bpm~Sitting systolic blood pressure - low >=18 yr: <90 and decrease of >=30 mmHg~Sitting systolic blood pressure - high >=18 yr: >160 and increase of >=30 mmHg~Sitting diastolic blood pressure - low 12-17 yr: <55 and decrease of >=12 mmHg~Sitting diastolic blood pressure - low >=18 yr: <50 and decrease of >=12 mmHg~Sitting diastolic blood pressure - high >=18 yr: >100 and increase of >=12 mmHg~Respiratory rate >=18 yr: >24 and increase of >=10 breaths/minute~Body temperature - low 12-17 yr: <96.5° Fahrenheit or <35.8° Celsius~Body temp - low >=18 yr: <96.5° F or <35.8° C~Body temp - high >=18 yr: >100.5° Fahrenheit"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set|||participants|||Number
1397535|NCT01287039|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 5-49 U/L.~Bilirubin: >=34.2 μmol/L~White blood cells: <=3.0 or >20 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Neutrophils: <=1.0 10^9/L~Eosinophils: >10.0 %~Platelets: <75 or >=700 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set|||participants|||Number
1399650|NCT01265550|Secondary|Number of Successful Participants With Functional Dysphagia|Presence of functional dysphagia as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1397536|NCT01287039|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Week 52|Randomized set|||CAEs in 52 weeks||95% Confidence Interval|Mean
1397537|NCT01287039|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The last postbaseline value for approximately 20 patients in each|Safety analysis set|||participants|||Number
1397538|NCT01287039|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms.~The during treatment average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set of participants with assessments within timeframe|||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
1397539|NCT01287039|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (Weeks 4, 8, 12 and 16) SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set of participants with assessments within the timeframe|||puffs/day||Standard Error|Least Squares Mean
1397540|NCT01287039|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.~The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
1397541|NCT01287039|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 478 (longest treatment time plus 2 weeks)|Randomized set|||weeks||95% Confidence Interval|Median
1397542|NCT01287039|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
1397543|NCT01287039|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were “patient-specific,” which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of patients with assessments at both timepoints|||units on a scale||Standard Error|Least Squares Mean
1397544|NCT01287039|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. Positive change from baseline scores indicate improvement in asthma control.~The during treatment (Weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set, including participants who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
1397545|NCT01287039|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.~Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Week 52|Randomized set|||CAEs in 52 weeks||95% Confidence Interval|Mean
1397546|NCT01287013|Secondary|Rates of Definitive Pathologic Diagnosis|Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||percent of accuracy|||Number
1397547|NCT01287013|Secondary|Compare the Number of Repositioning Maneuvers|To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||number of repositioning maneuvers||Standard Deviation|Mean
1397548|NCT01287013|Primary|Radiation Doses Between Xperguide and Conventional CT|Comparing radiation doses to determine if there is a change in the dose between the two interventions|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||mGy||Standard Deviation|Mean
1397549|NCT01287013|Primary|Accuracy of Final Device Path (Vector)|Comparing the accuracy of the path the biopsy needle took to get to the site|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||mm||Standard Deviation|Mean
1397550|NCT01287013|Primary|Comparing the Accuracy of Final Device Tip Position|To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters.|1 hour|Participants enrolled in the PILOT Arm were not randomized to the Cone Beam CT or Conventional CT Arms and were not included in the analysis. PILOT Participants were enrolled to familiarize operators with performing Xperguide procedures.|||mm||Standard Deviation|Mean
1397551|NCT01286818|Secondary|Best Overall Response [Anti-Tumor Activity of FOLFIRI Plus Ramucirumab (IMC-1121B)]|Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Every 8 weeks until PD (up to 49 weeks)|Safety population: Participants who received any quantity of study medication.|||participants|||Number
1397552|NCT01286818|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab|Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Vss data at the specified time points.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1397553|NCT01286818|Secondary|Clearance (CL) of Ramucirumab|The total body CL of ramucirumab on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered CL at steady state (CLss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable CL data at the specified time points.|||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
1397554|NCT01286818|Secondary|Half Life (t1/2) of Ramucirumab|t1/2 is the time required for the plasma/serum concentration to decrease 50%.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable t1/2 data at the specified time points.|||days||Geometric Coefficient of Variation|Geometric Mean
1397555|NCT01286818|Secondary|Area Under the Curve (AUC) of Ramucirumab|Reported for Day 1, Cycle 1 is AUC from time 0 extrapolated to infinity [AUC(0-inf)] and for Day 1, Cycle 5 is AUC over the dosing interval at steady state AUC(tau,ss).|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable AUC data at the specified time points.|||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
1397556|NCT01286818|Secondary|Maximum Concentration (Cmax) of Ramucirumab|The Cmax of ramucirumab in serum on Day 1, Cycle 1 and on Day 1, Cycle 5, which was also considered Cmax at steady state (Cmax,ss), is reported.|Day 1, Cycle 1 and Day 1, Cycle 5 (1 cycle=14 days)|Participants who received any quantity of study medication and had evaluable Cmax data at the specified time points.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1397557|NCT01286818|Secondary|Number of Participants With Serum Anti-IMC-1121B Antibodies (Immunogenicity)||Day 1 of Cycle 5 (Week 9), Cycle 6 (Week 11), Cycle 7 (Week 13), and Cycle 9 (Week 17) [(1 cycle=14 days)]|Participants who received any quantity of study medication and had evaluable immunogenicity data at the specified time points.|||participants|||Number
1397558|NCT01286818|Primary|Number of Participants With Ramucirumab Drug-Related Adverse Events or Serious Adverse Events|Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. Events related to Irinotecan, Levofolinate, and 5-fluorouracil (5-FU) were reported separately. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline to end of study (up to 49.3 weeks) plus 37 day follow-up|Safety population: Participants who received any quantity of study medication.|||participants|||Number
1397559|NCT01286818|Primary|Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period|DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03): Grade 4 neutropenia ≥7 days or ≥Grade 3 with bacteremia or sepsis; Absolute neutrophil count <1.0x10^9/Liters with fever ≥38.3°Celsius requiring intravenous antibiotic therapy; Grade 4 thrombocytopenia or ≥Grade 3 with bleeding requiring platelet transfusion; ≥Grade 3 altered coagulation tests and no anticoagulation; ≥Grade 4 or uncontrolled hypertension; ≥Grade 3 non-hematologic toxicity (except non-clinically significant Grade 3 events like electrolyte abnormality, hypersensitivity, and arthralgia/myalgia); urine protein >3 grams/24 hours; study drug-related toxicity causing Cycle 3, Day 1 treatment delay until Day 44 or later. Grade 3 or Grade 4 infusion-related reaction (hypersensitivity) due to ramucirumab or FOLFIRI, not a DLT.|Day 1, Cycle 1 through Day 1, Cycle 3 (1 cycle=14 days)|DLT population: All enrolled participants who either completed the first 3 administrations of study medication or discontinued study medication due to a DLT during the DLT assessment period (Day 1, Cycle 1 through Day 1, Cycle 3).|||participants|||Number
1397560|NCT01286805|Secondary|Quality of Recovery (QoR-40) Physical Comfort Dimension|Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome|First 24 hours after surgery||||QoR-40 Physical Comfort score||Standard Deviation|Mean
1397561|NCT01286805|Secondary|Patient Satisfaction|Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)|First 24 hours after surgery||||units on a scale||Standard Deviation|Mean
1397562|NCT01286805|Secondary|Requirement of Antiemetic Rescue|The number of participants who needed medication to treat their nausea and vomiting.|Day of surgery prior to discharge||||participants|||Number
1397563|NCT01286805|Secondary|Incidence of Vomiting|The number of participants who vomited.|Day of surgery prior to discharge||||participants|||Number
1397564|NCT01286805|Secondary|Incidence of Nausea|The number of participants with nausea.|Day of surgery prior to discharge||||participants|||Number
1397565|NCT01286805|Secondary|Narcotic Pain Medication Needed||Day of surgery prior to discharge||||equivalents milligrams oral morphine||Standard Deviation|Mean
1397566|NCT01286805|Secondary|Readiness to Discharge From Post-Anesthesia Care Unit (PACU)|Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.|Day of surgery prior to discharge||||minutes||Standard Deviation|Mean
1397567|NCT01286805|Primary|Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge|The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.|Day of surgery prior to discharge||||units on a scale||Standard Deviation|Mean
1397568|NCT01286753|Secondary|Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC)|AUC is a measure of the drug or biologic concentration in the body following administration.|Up to approximately 4 years|Data were not collected for this outcome.||||||
1397569|NCT01286753|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years)|Safety population, defined as enrolled participants who received at least one dose of study treatment.|||percentage of participants|||Number
1397570|NCT01286753|Secondary|Overall Survival|Overall survival: the interval between the date of first treatment to the date of death, regardless of the cause of death; participants who were alive at the time of the analysis were censored at the date of the last known alive; participants with no post baseline information were censored at the time of enrollment.|From the date of first treatment to the date of death for any cause (up to approximately 4 years)|Intent-to-Treat population, defined as all enrolled participants.|||months||95% Confidence Interval|Median
1397571|NCT01286753|Secondary|Progression-Free Survival|Progression-free survival: the interval between the day of first treatment and the first documentation of PD or death; participants who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression-free; participants without post baseline tumor assessments were censored at the time of enrollment. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the day of first treatment until the first documented PD or death (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||months||95% Confidence Interval|Median
1397572|NCT01286753|Secondary|Duration of Response|Duration of response (for participants with confirmed best response CR or PR): the interval between earliest qualifying response and date of progression of disease (PD) or death for any cause, whichever occurred first; participants with no documented progression after CR or PR were censored at the date of last known CR or PR, respectively. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. PD: ≥ 20% increase in the sum of diameters of target lesions, compared to the smallest sum on study.|From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years)|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||months||95% Confidence Interval|Median
1397573|NCT01286753|Secondary|Clinical Benefit Rate|Clinical benefit rate: the percentage of participants with confirmed CR, PR, or stable disease (SD; maintained for at least 6 months) as assessed by investigators according to RECIST v1.1. CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population, defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||percentage of participants||95% Confidence Interval|Number
1397574|NCT01286753|Secondary|Best Overall Response Rate in TKI-Experienced Participants|Best overall response rate was assessed by the investigators according to RECIST v1.1. Best overall response rate: the percentage of participants with best objective response of CR or PR (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 mm. PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Experienced group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||percentage of participants||95% Confidence Interval|Number
1397575|NCT01286753|Primary|Best Overall Response Rate in TKI-Naive Participants|Best overall response rate was assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Best overall response rate: the percentage of participants with best objective response of complete response (CR) or partial response (PR) (calculated as the number of participants with best response CR or PR divided by the total number of efficacy-evaluable participants). CR: disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to < 10 millimeters (mm). PR: ≥ 30% decrease in the sum of diameters of target lesions, compared to the baseline sum diameters.|Up to approximately 4 years|Efficacy population (TKI Naive group only), defined as all enrolled participants who received at least one dose of study treatment and excluding 3 participants in the TKI Experienced group who had previous BRAFi or MEKi treatment or withdrew consent.|||percentage of participants||95% Confidence Interval|Number
1397576|NCT01286740|Secondary|Plasma Concentration of RPV at Week 48|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.|Week 48|Participants with evaluable measurements for plasma concentration of RPV at Week 48 were analyzed.|||ng/mL||Standard Deviation|Mean
1397577|NCT01286740|Secondary|Plasma Concentration of RPV at Week 36|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.|Week 36|Participants with evaluable measurements for plasma concentration of RPV at Week 36 were analyzed.|||ng/mL||Standard Deviation|Mean
1397578|NCT01286740|Secondary|Plasma Concentration of RPV at Week 24|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.|Week 24|Participants with evaluable measurements for plasma concentration of RPV at Week 24 were analyzed.|||ng/mL||Standard Deviation|Mean
1397579|NCT01286740|Secondary|Plasma Concentration of EFV at Week 12|The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12|Week 12|Participants with evaluable measurements for plasma concentration of EFV at Week 12 were analyzed.|||ng/mL||Inter-Quartile Range|Mean
1397580|NCT01286740|Secondary|Plasma Concentration of RPV at Week 12|The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.|Week 12|Participants with measurements for plasma concentration of RPV at Week 12 were analyzed.|||ng/mL||Standard Deviation|Mean
1397581|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 8|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.|Week 8|Participants with evaluable measurements for plasma concentration of RPV and EFV at Week 8 were analyzed.|||ng/mL||Standard Deviation|Mean
1397582|NCT01286740|Secondary|Plasma Concentration of RPV and EFV at Week 6|The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.|Week 6|Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 6 were analyzed.|||ng/mL||Standard Deviation|Mean
1397588|NCT01286740|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.|Week 12|Full Analysis Set: participants who were enrolled into the study, received at least one dose of study drug and had no major protocol violation|||percentage of participants|||Number
1397589|NCT01286558|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||participants|||Number
1397590|NCT01286558|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||percentage of participants|||Number
1397591|NCT01286558|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||percentage of participants|||Number
1397592|NCT01286558|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP >=140 mmHg at reference baseline|||percentage of participants|||Number
1397593|NCT01286558|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated DBP >=90 mmHg at reference baseline|||percentage of participants|||Number
1397594|NCT01286558|Secondary|Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Deviation|Mean
1397595|NCT01286558|Secondary|Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Deviation|Mean
1397596|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
1397597|NCT01286558|Secondary|Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP|Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined|Pseudo-baseline, 14 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
1397598|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
1397599|NCT01286558|Secondary|Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined|Reference baseline, 8 weeks|ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements|||mm Hg||Standard Error|Least Squares Mean
1397600|NCT01286558|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|FAS|||mm Hg||Standard Error|Least Squares Mean
1397601|NCT01286558|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Reference baseline, 8 weeks|Full analysis set (FAS)|||mm Hg||Standard Error|Least Squares Mean
1397602|NCT01286493|Primary|Rabies Neutralizing Antibody Titers|"Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response.~for 7 times in 1 year."|Day 360|As preliminary study, the number of participants was estimated to be above 15 - 20 cases.|||IU/ml||Full Range|Geometric Mean
1397620|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures: STAI|Change From Baseline of Chamomile on Daytime Functioning Measures, depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI). STAI scores range for each subtest from 20–80, the higher score indicating greater anxiety. A cut point of 39–40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale|Baseline and 28 days||||units on a scale||Standard Deviation|Mean
1397603|NCT01286480|Secondary|MyHeart Score|Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. The MyHeart scale was developed for this study and has a grade 4.6 reading level. It consists of seven short answer or multiple-choice questions. Given the heterogeneity of prior medical and surgical interventions and need for medications in adolescents with heart disease, the denominator for some questions varied from one participant to the next. Accordingly, each participant was assigned a percentage correct score (numerator/denominator×100) at each time point. Higher percentage correct score reflects better patient knowledge of his/her CHD|Baseline, 1 month and 6 months||||percentage of score||Standard Deviation|Mean
1397604|NCT01286480|Primary|Transition Readiness Assessment Questionnaire (TRAQ) Score|The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of “No, I do not know how” and a score of 5 assigned for responses of “Yes, I always do this when I need to.” The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy.|Baseline, 1 month and 6 months|The intervention involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. The youth in the usual care arm see a nurse for vitals. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.|||units on a scale||Standard Deviation|Mean
1397605|NCT01286454|Secondary|Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.|||hr||Standard Deviation|Mean
1397606|NCT01286454|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1397607|NCT01286454|Primary|Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1397608|NCT01286454|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1397609|NCT01286454|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the N (number of participants analyzed) is signifying the number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1397610|NCT01286402|Secondary|Perinatal/Neonatal Outcomes||at neonatal discharge from hospital following delivery|||||||
1397611|NCT01286402|Secondary|Maternal Side Effects||during treatment, end of treatment and at 2 week postpartum visit|||||||
1397612|NCT01286402|Secondary|Self-reported Reduction in Number of Cigarettes Smoked Per Day||at 1 week post treatment and at 2 week postpartum visit|||||||
1397613|NCT01286402|Secondary|Continuous Abstinence From Birth to 2nd Week Postpartum Followup||at 2nd week postpartum followup visit|||||||
1397614|NCT01286402|Secondary|Continuous Abstinence From End of Treatment Through the 2 Week Followup||at two week followup visit|||||||
1397615|NCT01286402|Secondary|Enrollment, Retention and Compliance Rates||1 year (estimated)|||||||
1397616|NCT01286402|Primary|7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment||1 week post treatment||||participants|||Number
1397617|NCT01286324|Secondary|Changes From Baseline in the Safety and Tolerability of Chamomile|Changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo were measured by counting all participants who reported a serious or non-serious adverse event at the weekly check-ins that were established.|once per week during study and day 28||||Participants|||Count of Participants
1397618|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ]|the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})|Baseline and 28 days|Before first participants completed the study, the decision was made not to gather this data for reasons of cost.||||||
1397619|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale|"Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale (FSS) Range: 9 to 63. The 9-item scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.~The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity."|Baseline and 28 days||||units on a scale||Standard Deviation|Mean
1397621|NCT01286324|Secondary|Change From Baseline of Chamomile on Daytime Functioning Measures: BDI|"Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days:~the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II), which is scored on a scale of 0 to 63 where a total score of 0–13 is considered minimal range (minimal depression), 14–19 is mild, 20–28 is moderate, and 29–63 is severe."|baseline and day 28||||units on a scale||Standard Deviation|Mean
1397622|NCT01286324|Primary|Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.|"Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days:~the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals The total sleep time divided by time-in-bed, multiplied by 100. This measure is our primary aim (SE)."|baseline and day 28||||percentage of time asleep||Standard Deviation|Least Squares Mean
1397623|NCT01286311|Secondary|Presence of an Aspirin Prescription|This will measure the presence of an aspirin prescriptions on the medication list in the electronic medical record.|9 months|38 patients in the intervention arm and 50 patients in the control arm had aspirin listed in their medication list in the electronic medical record as the start of the study therefore they were excluded from this analysis.|||% patients w/aspirin now on med list|||Number
1397624|NCT01286311|Secondary|Percentage of Patients With Uncontrolled Hypertension Who Had an Increase in the Number of Antihypertensive Medication Drug Classes Prescribed|This will measure the percentage of participants who had uncontrolled hypertension at baseline who had an increase in the number of antihypertensive medication drug classes prescribed within 9 months.|9 months|Among patients with uncontrolled hypertension, 76 of the 218 in the intervention arm and 85 of 217 in the control arm were included.|||percentage of participants|||Number
1397625|NCT01286311|Secondary|Medication Prescriptions for Dyslipidemia|This will look at whether lipid lowering medications (LLM) were prescribed for dyslipidemia.|9 months||||% of patients with New Rx for LLM|||Number
1397626|NCT01286311|Secondary|Frequency of Clinical Encounters|This will measure the difference in frequency of clinical encounters in the electronic medical record.|9 months||||% of patients with any office visit|||Number
1397627|NCT01286311|Primary|Comparative Outcomes: Intervention Group LDL Reduction Compared to Control Group LDL Reduction|Significant LDL cholesterol reduction at 9 months Definition: Percentage of patients with LDL-C repeated and which is at least 30 mg/dl lower than baseline|9 months||||% of patients with major LDL reduction|||Number
1397628|NCT01286207|Primary|Number of Participants With Drug-related Lab Adverse Experiences|"Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) laboratory adverse experience (LAE).~A LAE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product."|Up to 12 weeks|All patients who took study medication and had lab test(s)were included in the analysis.|||participants|||Number
1397629|NCT01286207|Primary|Number of Participants Who Discontinued Due to Clinical Adverse Experiences||Up to 12 months|All patients who took study medication were included in the analysis.|||participants|||Number
1397630|NCT01286207|Primary|Number of Participants With Drug-related Clinical Adverse Experiences|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Up to 12 months|All patients who took study medication were included in the analysis.|||participants|||Number
1397631|NCT01286207|Primary|Number of Participants With Serious Clinical Adverse Experiences|Serious clinical adverse experiences (CAEs) are any adverse events (AEs) occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Up to 12 months|All patients who took study medication were included in the analysis.|||participants|||Number
1397632|NCT01286207|Primary|Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug|Headache severity was rated on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain) immediately before initial dose and at 2 hours thereafter. Pain relief was defined as a reduction of headache severity from grades 2/3 at baseline to 0/1.|2 hours after initial dose of test drug|All patients who took study medication and filled out their diary cards were included in the analysis of efficacy. No data were imputed.|||percent of headaches||Inter-Quartile Range|Median
1397633|NCT01286168|Secondary|Per Drain Analysis: Drain Bulb Fluid Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.|||drains|Participants||Number
1397634|NCT01286168|Secondary|Per Drain Analysis: Drain Tubing Colonization at Removal||Approximately one month after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.|||drains|Participants||Number
1397635|NCT01286168|Primary|Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week||Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.|||drains|Participants||Number
1397636|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 1 Year||Approximately one year after surgery||||participants|||Number
1397637|NCT01286168|Secondary|Number of Subjects With Surgical Site Infection Within 30 Days||Approximately 30 days after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.|||participants|||Number
1397662|NCT01286012|Secondary|"The Incidence of Patient Failures, Defined as ≥ 25% Increase From Baseline in ESA Dose Sustained Continuously for ≥ 8 Weeks."||ESA dose is monitored and recorded at each dialysis session for 36 weeks.|||||||
1397638|NCT01286168|Secondary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.|Approximately 2 weeks after surgery|Analysis was modified intent-to-treat (IIT). Reported here only in those subjects where drain removal was later than primary endpoint collection.|||participants|||Number
1397639|NCT01286168|Secondary|Number of Subjects With Drain Tubing Colonization at Removal|Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.|Approximately two weeks after surgery|Analysis was modified intent-to-treat; subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis. 2 subjects missed endpoint due of protocol deviation or discontinuation, and 2 had the sterility of their drain tubing compromised by external exposures.|||participants|||Number
1397640|NCT01286168|Primary|Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week|Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.|Approximately 1 week after surgery|Analysis was modified intent-to-treat (IIT); subjects who withdrew or were screen failures before study intervention were excluded. All patients who completed were included in the analysis.|||participants|||Number
1397641|NCT01286129|Secondary|Change in Nasal Lavage Eosinophils After Allergen Challenge|Change in nasal lavage eosinophil percentages in allergic asthmatic and allergic non asthmatic at baseline and at 7h post first and last challenge|At 7 hours post first and last challenge compared to baseline||||percentage of nasal lavage eosinophils||Standard Error|Mean
1397642|NCT01286129|Primary|Change in Sputum Eosinophils Following Allergen Challenge|Eosinophil is an inflammatory cell found in the lungs. Sputum is obtained from hypertonic inhalation. patients expectorate in a sterile dish and mucus plugs are selected and treated to obtain cells. cells are transferred on a slide and a differential count is obtained where eosinophils are counted.|At 7 hours post first and last challenge compared to baseline||||percentage of sputum eosinophils||Standard Error|Mean
1397643|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Partial Response (PR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as PR based on IMWG response criteria as >=50% reduction of serum and reduction in 24-h urinary M protein by >=90% or to <200 mg/24 h; or serum/urine M protein unmeasurable:>=50% decrease in the difference between involved and uninvolved FLC levels; or serum/urine M protein and FLC assay unmeasurable: >=50% reduction in plasma cells provided baseline bone marrow plasma cell percentage was >=30%; or plus if present at baseline: >=50% reduction in size of soft tissue plasmocytomas.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Percentage of participants|||Number
1397644|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Stable Disease (SD) or Progressive Disease (PD) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as SD based on IMWG response criteria as not meeting criteria for CR, VGPR, PR, or progressive disease; PD as Increase of >=25% from lowest response level in any one or more of the following: serum M protein (absolute increase >=0.5 g/dl)c or urine M protein (absolute increase >=200 mg/24 h); or serum/urine M protein unmeasurable: difference between involved and uninvolved free light chain (FLC) levels; absolute increase >10 mg/dL; or % bone marrow plasma cells: absolute value >=10% or definite development of new bone lesions or soft tissue plasmocytomas or definite increase in the size of existing bone lesions or soft tissue plasmocytomas; or development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Percentage of participants|||Number
1397645|NCT01286077|Secondary|Tumor Response: Percentage of Participants With Very Good Partial Response (VGPR) or Stringent Complete Response (sCR) or Complete Response (CR) Based on International Myeloma Working Group (IMWG) Response Criteria|Tumor response was assessed as VGPR based on IMWG response criteria if, a) serum/urine M protein detectable by immunofixation but not on electrophoresis or; b) greater than or equal to 90% reduction in serum M protein plus urine M protein level less than 100 milligram/24 hour. CR=normal free light chain (FLC) ratio and absence of phenotypically aberrant plasma cells (PC) in bone marrow with a minimum of 3000 total PC analyzed by multiparametric flow cytometry; Complete response (CR) negative immunofixation on the serum and urine and, disappearance of any soft tissue plasmocytomas and <5% plasma cells in bone marrow.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Percentage of participants|||Number
1397646|NCT01286077|Secondary|Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)|Subjects were asked to rate their general state of health on a Visual analog scale (in millimeter [mm]) ranging from 0 (worst state of health) to 100 (best conceivable state of health) mm.|Baseline up to end of study (approximately 4 years 7 months)|FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. Missing data was imputed by last observation carried forward (LOCF) method.|||millimeter (mm)||Standard Deviation|Mean
1397647|NCT01286077|Secondary|Overall Survival|Overall survival defined as time from first treatment of MMY, i.e. day of first dose of induction therapy for MMY to date of death|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||Months||Standard Error|Median
1397663|NCT01286012|Secondary|"The Incidence of Patient Responders Defined as ≥ 25% Decrease From Baseline in ESA Dose Sustained Continuously for ≥ 8 Weeks."||ESA dose is monitored and recorded at each dialysis session for 36 weeks.|||||||
1397648|NCT01286077|Secondary|Karnofsky Performance Status|"The Karnofsky performance status is a way to quantify cancer patients' general well-being and activities of daily life and runs from 100 to 0, where 100 is perfect health and 0 is death."|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."|||Units on a scale||Standard Deviation|Mean
1397649|NCT01286077|Secondary|Change From Baseline in Spine T-score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of ‘50’ and a standard deviation of ‘10’. T score lower than its mean indicate low bone mineral density.|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure. Missing data was imputed by last observation carried forward (LOCF) method."|||T score||Standard Deviation|Mean
1397650|NCT01286077|Secondary|Appearance of New Bone Lesions Compared to Baseline|Appearance of new bone lesions assessed by skeletal survey compared to baseline|Baseline up to end of study (approximately 4 years 7 months)|Data could not be summarised statistically due to insufficient data at End of treatment.|||subjects|||Number
1397651|NCT01286077|Secondary|Number of Patients With Skeletal Events|Number of patients with skeletal-related events (i.e. pathological fracture (vertebral, non-vertebral, combined), radiotherapy, spinal cord compression, orthopaedic surgery, hypercalcaemia) occurring over 24 months study period|Baseline up to end of study (approximately 4 years 7 months)|"FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. N (number of subjects analyzed) signifies the subjects evaluable this measure."|||patients|||Number
1397652|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Dickkopf Homolog 1 (DKK-1)|Bone markers Dickkopf homolog 1 (DKK-1) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."|||Picomole per liter||Standard Deviation|Mean
1397653|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers: Carboxyterminal Collagen Crosslinks (CTX-I)|Change from Baseline in Biochemical Bone Markers: CTX-I was assessed|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."|||Nanogram per liter||Standard Deviation|Mean
1397654|NCT01286077|Secondary|Change From Baseline in Biochemical Bone Markers:Carboxyterminal Telopeptide of Type I Collagen (ICTP), Osteocalcin, Bone-specific Alkaline Phosphatase (BAP)|Bone markers (carboxyterminal telopeptide of type I collagen (ICTP), osteocalcin (Oc) and bone-specific alkaline phosphatase (BAP) was measured on serum samples.|Baseline up to end of study (approximately 4 years 7 months)|"FAS was used for analysis. N (number of subjects analyzed) signifies the subjects evaluable this measure and n=number pf participants analysed for this outcome measure at specific time point. Missing data was imputed by last observation carried forward (LOCF) method."|||Microgram per liter||Standard Deviation|Mean
1397655|NCT01286077|Secondary|Progression Free Survival|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Baseline up to end of study (approximately 4 years 7 months)|Full Analysis Set (FAS) included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data.|||Months||Standard Error|Mean
1397656|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Femur at End of Treatment|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the end of treatment EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:8 patients in the bortezomib group and 8 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter|||g/mm2||Standard Deviation|Mean
1397657|NCT01286077|Primary|Change From Baseline in Bone Mineral Density (BMD) in the Spine at End of Treatment (EOT)|Change from baseline in bone mineral density (BMD) will be assessed by dual energy x-ray absorptiometry scans at baseline and the EOT visit|at screening (i.e. between 14 and 1 days prior to start of treatment) and at end of treatment (EOT), i.e. 24 weeks after randomization or until start of alternative MMY therapy, if earlier|ITT analysis:13 patients in the bortezomib group and 14 patients in the non-treated control group did not have values at the 2 timepoints to allow calculation of the parameter|||g/mm2||Standard Deviation|Mean
1397658|NCT01286012|Secondary|Iron Delivery to the Erythron as Estimated by Hemoglobin Generation in Response to Erythropoietin (ESA Response Index, or ERI, Calculated as ESA Dose/Hgb). The ERI Will Also be Divided by Body Weight in Kilograms to Obtain a Modified ERI (ERI/kg).||Hemoglobin measured weekly; ESA dose recorded at each visit for 36 weeks, pre-dialysis body weight recorded at each visit for the first four weeks of the study and then weekly for the rest of the study.|||||||
1397659|NCT01286012|Secondary|Markers of Inflammation and Oxidative Stress||measured pre and post-dialysis at Week 1 Visit 2 and pre-dialysis at Weeks 4, 12, 24, and 36 of the study.|||||||
1397660|NCT01286012|Secondary|The Amount of Supplemental Intravenous (IV) Iron Needed.||Recorded at every dialysis session for 36 weeks||||mg/week||Standard Deviation|Mean
1397661|NCT01286012|Secondary|Stability of Hemoglobin Over Time (Maintenance of Hemoglobin Between 9.5-11.5 g/dL, and Variability in Hemoglobin [Hgb-var]).||measured weekly for 36 weeks.|||||||
1397664|NCT01286012|Primary|The Percent Change From Baseline in ESA Dose Required to Maintain Hemoglobin in the Target Range, Adjusted for Hgb.|The statistical endpoint is the change from baseline between groups at End of Treatment, where the baseline prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the two-week period of time immediately prior to randomization. The end-of-treatment prescribed ESA dose (expressed as U/week epoetin) per subject is defined as the average weekly dose of ESA prescribed for administration over the last two weeks of the treatment period.|Hemoglobin measured weekly and serum ferritin and Transferrin Saturation (TSAT) determined every other week; ESA dose recorded at each visit for 36 weeks.|MITT population: Randomized subjects who received at least one dose of study drug and also received ESA during the treatment period.|||Percent change||Standard Error|Least Squares Mean
1397665|NCT01285947|Primary|Pain Rated by Subjects|"The mean pain scores will be compared between naïve subjects and non-naïve subjects averaged over the anatomical sites: periocular (temple), midface/cheek, and abdomen and over all the different treatments.~Pain scores were recorded along a Visual Analog Scale (VAS) with 0 (no pain- better) to 10 (maximal pain-worst). This is a 10 cm long line in which the subject was asked to draw a line on the scale with 0 (no pain- better) at one end to 10 (maximal pain-worst) at the other end. The drawn line was measured on the 10 cm line using a ruler to obtain the score."|3 hours for all treatments in one visit||||Units on a scale||Standard Deviation|Mean
1397666|NCT01285908|Secondary|Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)|Plasma levels of dihydroxyphenylglycol are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||nmol/L||Standard Deviation|Mean
1397667|NCT01285908|Secondary|Arterial Plasma Levels of Norepinephrine|Plasma levels of norepinephrine are obtained from blood samples via IV catheter.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||nmol/L||Standard Deviation|Mean
1397668|NCT01285908|Secondary|Total Peripheral Resistance|The extent to which norepinephrine infusion affected total peripheral resistance, by comparison of total peripheral resistance at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mmHg/(min/L)||Standard Deviation|Mean
1397669|NCT01285908|Secondary|Cardiac Output|The extent to which norepinephrine infusion affects cardiac output, by comparison of cardiac output at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||L/min||Standard Deviation|Mean
1397670|NCT01285908|Primary|Blood Pressure (Mean)|The extent to which norepinephrine infusion maintains average blood pressure, by comparison with the fractional changes in blood pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mm Hg||Standard Deviation|Mean
1397671|NCT01285908|Secondary|Cardiac Stroke Volume|The extent to which norepinephrine infusion affects cardiac stroke volume, by comparison of cardiac stroke volume at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mL||Standard Deviation|Mean
1397672|NCT01285908|Secondary|Heart Rate|The extent to which norepinephrine infusion affects heart rate, by comparison of beat-to-beat heart rate at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||bpm||Standard Deviation|Mean
1397673|NCT01285908|Primary|Blood Pressure (Diastolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in diastolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mm Hg||Standard Deviation|Mean
1397674|NCT01285908|Primary|Blood Pressure (Systolic)|The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.|2 experimental days|One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.|||mm Hg||Standard Deviation|Mean
1397675|NCT01285843|Secondary|Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.|Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.|6 months, 1 year||||participants|||Number
1397699|NCT01285518|Secondary|Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023|"Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).~Participants who received PF-05231023 with C-terminal and N-terminal AUClast were reported."|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ng*hour[H]/mL||Standard Deviation|Geometric Mean
1397676|NCT01285843|Secondary|Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.|The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.|6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HAAS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).|||units on a scale (0-18)||Standard Deviation|Mean
1397677|NCT01285843|Secondary|Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score|"The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity.~The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative."|6 weeks, 6 months, 1 year|20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HHS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).|||units on a scale (0-100)||Standard Deviation|Mean
1397678|NCT01285843|Primary|Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.||0-12 months||||g/cm2||Standard Deviation|Mean
1397679|NCT01285791|Secondary|Change in Glucose and Triglyceride Blood Level|finding correlation between sonographic outcome using ultrasound, as measured by the decrease in the level of visceral fat-by centimeters, weight loss and blood levels of triglycerides and glucose.|18 months|||||||
1397680|NCT01285791|Primary|Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.|morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .|18 months||||visceral fat reduction in centimeters||Standard Error|Mean
1397681|NCT01285713|Secondary|Dextrose Containing Intravenous Fluids (IVF) Affect Clinically Relevant Outcomes|Hypothesis 2: Admission rates, revisits to the emergency department (ED) or primary care physician, and length of illness will be decreased with the addition of dextrose to IVF. Physician and parental satisfaction will be increased with the addition of dextrose to IVF.|4 hours|||||||
1397682|NCT01285713|Primary|Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis|Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.|4 hours||||mmol/L||Standard Deviation|Mean
1397683|NCT01285635|Secondary|Median Progression Free Survival in Months|Progression is defined, by RECIST (Response Evaluation Criteria in Solid Tumors), as at least a 20% increase in the sum of the longest diameter of target lesions.|3 Years||||months||95% Confidence Interval|Median
1397684|NCT01285635|Secondary|Median Overall Survival in Months||3 Years||||months||95% Confidence Interval|Median
1397685|NCT01285635|Secondary|Incidence of Grade 3 and 4 Toxicities by Arm|Measure the grade III/IV toxicities experienced by patients with advanced, locally recurrent, or metastatic SCCHN|3 years||||participants|||Number
1397686|NCT01285635|Secondary|Median Duration of Response For All Groups Combined||3 years|All patients on study|||months||Full Range|Median
1397687|NCT01285635|Primary|Number of Patients With a Complete Response (CR) and Partial Response (PR)|The primary objective is to estimate the proportion of patients with a complete response (CR) and partial response(PR) defined by RECIST (Response Evaluation Criteria in Solid Tumors). CR is defined as the disappearance of all target lesions and PR is defined as at least a 20% decrease in the sum of the longest diameter of target lesions.|12 months||||Patients|||Number
1397688|NCT01285609|Secondary|Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy|||months||95% Confidence Interval|Median
1397689|NCT01285609|Secondary|Overall Survival (OS) in All Randomized Participants at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 705 deaths, up to June 2015 (approximately 48 months post study start)|All randomized participants|||months||95% Confidence Interval|Median
1397700|NCT01285518|Primary|Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry|Criteria for abnormal cardiac rhythms was based on investigator’s discretion and were reported as adverse event (AE), as planned.|From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.||||||
1397690|NCT01285609|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint|Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.|Randomization until 518 deaths, up to June 2015 (approximately 48 months post study start)|All treated participants who received at least one dose of blinded therapy|||months||95% Confidence Interval|Median
1397691|NCT01285518|Secondary|Volume of Distribution at Steady State (Vss) of PF-05231023|Vss was calculated by dividing the area under the first moment curve from time zero to infinity [AUMC(0-∞)] with the product of area under the curve from time zero to extrapolated infinite time [AUC (0 - ∞)] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||L||Standard Deviation|Geometric Mean
1397692|NCT01285518|Secondary|Back-extrapolated Concentration at Time Zero (C0) of PF-05231023|C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than [<] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.|0.25 H post-dose to Bo on Day 1|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. C0 was calculated for cohort 1 (group: PF-05231023 0.5 mg) and 2 (group: PF-05231023 1.5 mg) only as per planned analysis, hence results for the same reported.|||ng/mL||Standard Deviation|Geometric Mean
1397693|NCT01285518|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||ng*hr/ml||Standard Deviation|Geometric Mean
1397694|NCT01285518|Secondary|Apparent Volume of Distribution (Vz) of PF-05231023|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||Liter||Standard Deviation|Geometric Mean
1397695|NCT01285518|Secondary|Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.|Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||liter per hour||Standard Deviation|Geometric Mean
1397696|NCT01285518|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||hour||Standard Deviation|Mean
1397697|NCT01285518|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ng/mL||Standard Deviation|Geometric Mean
1397698|NCT01285518|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
1397701|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1397702|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
1397703|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
1397704|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
1397705|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||mcg/mL||Standard Deviation|Mean
1397706|NCT01285518|Primary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1|Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1397707|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 15|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1397708|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 7|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. Here,'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1397709|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 5|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||nanogram per millileter (ng/mL)||Standard Deviation|Mean
1397710|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 3|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||nanogram per millileter (ng/mL)||Standard Deviation|Mean
1397711|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.|Day 2|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.|||ng/mL||Standard Deviation|Mean
1397712|NCT01285518|Primary|Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1|Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.|Day 1|Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1397713|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 34|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 34|Safety population. No participant was involved in groups: PF-05231023 0.5,1.5,5,15,50,100 mg and placebo for this time point of outcome measure, hence results were not reported for the same.'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
1397714|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 22|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 22|Safety population included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
1397715|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 15|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 15|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
1397716|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 8|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 8|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.|||participants|||Number
1397717|NCT01285518|Primary|Number of Participants With Anti-Drug Antibodies (ADA): Day 1|Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.|Day 1|Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.|||participants|||Number
1397718|NCT01285518|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6*lower limit of normal (LLN) or >1.5*upper limit of normal (ULN).|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1397719|NCT01285518|Primary|Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels|Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose <50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration <=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration <=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration <=70 mg/dL).|Day 0 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1397720|NCT01285518|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia’s Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec for PR interval and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia’s Correction).|Screening up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1397721|NCT01285518|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Day 1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1397722|NCT01285518|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities was reported.|Day -1 up to Day 15|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1397723|NCT01285518|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 22|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1397724|NCT01285518|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator’s discretion and were reported as adverse event (AE), as planned.|Day -1 up to Day 22|Data was not collected since this outcome measure was not analyzed as per Sponsor’s discretion.||||||
1397725|NCT01285492|Secondary|Change in Pre-dose Forced Vital Capacity (FVC) From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.|||Litres||Standard Deviation|Mean
1397726|NCT01285492|Secondary|Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).|Weeks 3, 6, 12, 24, 36, 52|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug.|||Litres||Standard Deviation|Mean
1397727|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia’s QTc Values at Any Time-point Over the Whole Treatment Period|Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
1397728|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
1397729|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
1397730|NCT01285492|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
1397731|NCT01285492|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death|An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.|52 weeks|The safety set included all patients who received at least one dose of study drug.|||Participants|||Number
1397732|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397733|NCT01285427|Primary|SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397734|NCT01285427|Primary|SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397735|NCT01285427|Primary|SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397736|NCT01285427|Primary|SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397737|NCT01285427|Primary|SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397738|NCT01285427|Primary|SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397739|NCT01285427|Primary|SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)|SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397740|NCT01285427|Primary|All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)|All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method|10 weeks||||percentage of concordant alleles|Participants|90% Confidence Interval|Number
1397741|NCT01285401|Post-Hoc|Percentage of Subjects With Disease Activity Free Status (Alternate Definition) at Week 48|Disease activity free (DAF) status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no confirmed expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions. Confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
1397743|NCT01285401|Secondary|Percentage of Subjects Treated With Glucocorticoids Due to Relapses|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
1397744|NCT01285401|Secondary|Total Number of Reported Relapses at All Time Points up to 48 Weeks|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||number of relapse per subject||Standard Deviation|Mean
1397745|NCT01285401|Secondary|Annualized Relapse Rate at Week 48|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||relapse per year||Standard Deviation|Mean
1397746|NCT01285401|Secondary|Number of Subjects With Relapse|Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject’s reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.|Baseline upto 48 weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||subjects|||Number
1397747|NCT01285401|Secondary|Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here “N” signifies number of subjects analyzed for respective outcome measure (here in the subgroup of subjects having new or enlarging T2 lesions).|||percentage of new T1 hypointense lesions||Standard Deviation|Mean
1397748|NCT01285401|Secondary|Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
1397749|NCT01285401|Secondary|Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48||48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
1397750|NCT01285401|Secondary|Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)||Baseline, 48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subjects analyzed for respective outcome measure."|||millimeter^3 (mm^3)||Standard Deviation|Mean
1397751|NCT01285401|Secondary|Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new T2 lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||lesions per subject per scan||Standard Deviation|Mean
1397752|NCT01285401|Secondary|Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48|CUA lesions was defined as new T1 (Gd enhancing) lesions, new Relaxation time 2 (T2) lesions, or enlarging T2 lesions.|48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||lesions per subject per scan||Standard Deviation|Mean
1397753|NCT01285401|Secondary|Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48||48 Weeks|"ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here N signifies number of subject analyzed for respective outcome measure."|||lesions per subject per scan||Standard Deviation|Mean
1397754|NCT01285401|Secondary|Number od Subjects With Confirmed EDSS Progression|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Baseline upto 48 Weeks|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||subjects|||Number
1398035|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: AUClast|AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set: Participants enrolled in the PK substudy were analyzed.|||hours x ng/mL||Standard Deviation|Mean
1397755|NCT01285401|Secondary|Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
1397756|NCT01285401|Secondary|Percentage of Relapse-free Subjects at Week 48|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48|ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
1397757|NCT01285401|Primary|Percentage of Subjects With Disease Activity Free Status up to Week 48|Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.|Up to Week 48|ITT set included all randomized subjects who received at least 1 dose of the IMP.|||percentage of subjects|||Number
1397758|NCT01285323|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion.|Baseline visit (prior to reslizumab exposure), Weeks 16, 32, 48 and 52|Safety analysis set|||participants|||Number
1397759|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse (high): >100 and increase of >= 30 beats/minute~Sitting systolic blood pressure (low): <90 and decrease of >= 30 mmHg~Sitting systolic blood pressure (high): >160 and increase of >= 30 mmHg~Sitting diastolic blood pressure (low): <50 and decrease of >=12 mmHg (if 12-17 years old: <55 and decrease of >=12 mmHg 0~Sitting diastolic blood pressure (high): >100 and increase of >=12 mmHg~Respiratory rate (low): <6 breaths/minute~Respiratory rate (high): >24 and increase of >=10 breaths/minute~Body temperature (low): <35.8° Celsius~Body temperature (high): >=38.1 and increase of >=1.1° Celsius"|Week 4 to Week 52|Safety analysis set including participants who contributed data to the analysis|||participants|||Number
1397760|NCT01285323|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Urate: M>=625, F>=506 μmol/L~Aspartate aminotransferase (AST): >=3*upper limit of normal (ULN)~Alanine aminotransferase (ALT): >=3*ULN~GGT = gamma-glutamyl transpeptidase: >= 3*ULN~Total bilirubin: >=34.2 μmol/L~White blood cells (low): <=3.0*10^9/L~White blood cells (high): >=20*10^9/L~Hemoglobin (age >=18 years): M<=115, F<=95 g/dL~Hematocrit (age >=18 years): M<0.37, F<0.32 L/L~Eosinophils/leukocytes: >=10.0%~Platelets: <=75*10^9/L~Neutrophils: <=1.0*10^9/L~Urinalysis: blood, ketones, glucose, and protein: >=2 unit increase from baseline"|Week 4 to Week 52|Safety analysis set, including participants who contributed to the analysis|||participants|||Number
1397761|NCT01285323|Primary|Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization CAEs were adjudicated by committee to assure consistency.~Adjusted CAE rate and confidence intervals for the two criteria were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.|||CAEs in 52 weeks||95% Confidence Interval|Mean
1397762|NCT01285323|Secondary|Participants With Treatment-Emergent Adverse Events TEAE)|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.|Safety analysis set|||participants|||Number
1397776|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397763|NCT01285323|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks and 52 Weeks Using Mixed Model for Repeated Measures|"The blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test. Results of all differential blood tests conducted after randomization were blinded.~The during treatment average eosinophil count was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements. The 'over 16 weeks' value used data from Weeks 4, 8, 12 and 16. The 'over 52 weeks' value used all the during study time points listed in the Time Frame field.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 or early withdrawal|Randomized set including patients who contributed at least once to the analysis.|||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
1397764|NCT01285323|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (Weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set including patients who contributed at least once to the analysis.|||SABA puffs per day||Standard Error|Least Squares Mean
1397765|NCT01285323|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms.~The during treatment (Weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
1397766|NCT01285323|Secondary|Kaplan-Meier Estimates for Time to First Clinical Asthma Exacerbation (CAE)|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician's office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. The distributions were compared by a log rank test stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other)."|Day 1 to Day 526 (longest treatment time plus 2 weeks)|Randomized set|||weeks||95% Confidence Interval|Median
1397767|NCT01285323|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (Weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Randomized set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
1397768|NCT01285323|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) to Week 16|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were patient-specific, which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life."|Day 1 (baseline, pre-dose), Week 16|Randomized set of participants with assessments at each timepoint.|||units on a scale||Standard Error|Least Squares Mean
1397777|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means “not at all,” and 4 means “very much.” The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1398036|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: Tmax|Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set|||hours||Inter-Quartile Range|Mean
1397769|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. During study (Weeks 4, 8, 12 and 16) average value used a mixed effect model for repeated measures (MMRM) with treatment group, visit, treatment and visit interaction, and stratification factors as fixed effects and participant as a random effect. Covariates for baseline values were also included in the model; for pulmonary function test analyses, covariates for height and sex were included as well.~Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Includes participants who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
1397770|NCT01285323|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) At Week 16|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.~Positive change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Week 16|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug. Number analyzed reflects participants with both baseline and Week 16 assessments.|||liters||Standard Error|Least Squares Mean
1397771|NCT01285323|Primary|Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment|"An exacerbation event was considered a CAE if the patient met either or both of the criteria listed below and this was corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma:~use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days; or an increased 2 or more fold for at least 3 or more days for patient's already on corticosteroids.~asthma-related emergency treatment, such as an unscheduled visit to the physician’s office or emergency room for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms, or an asthma-related hospitalization.~CAEs were adjudicated by committee to assure consistency. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors.~Results are offered as adjusted means."|Day 1 to Month 12|Randomized set includes all patients who were randomly assigned to a treatment group at enrollment, regardless of whether or not a patient took any study drug.|||CAEs in 52 weeks||95% Confidence Interval|Mean
1397772|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Year 2|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397773|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Year 2|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397774|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Year 2|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397775|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Year 2|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397778|NCT01285310|Secondary|Percentage Change From Baseline in the Individual American College of Rheumatology Components at Year 2|"The Individual ACR Components were defined as follows:~Tender Joint Count (out of 68 joints)~Swollen Joint Count (out of 66 joints)~Subject Assessment of Pain (0 to 100 mm VAS)~Subject Global Assessment of Disease Activity (0 to 100 mm VAS)~Physician Global Assessment of Disease Activity (0 to 100 mm VAS)~HAQ-DI Score~Acute Phase Reactant High Sensitivity C-Reactive Protein (hsCRP, mg/dL) Erythrocyte Sedimentation Rate (ESR)~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1402099|NCT01246206|Primary|Severity of Acute GVHD|Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks|Assessed first 6 months post transplant|Those participants who contracted Acute GVHD|||% of participants with sever aGVHD||95% Confidence Interval|Number
1397779|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Year 2|"The DAS 28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's global assessment of disease activity (SGA ). A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397780|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397781|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Year 2|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject's Global Assessment of Disease Activity measured on a 10 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 10 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 mm VAS, where 0 mm = lowest disease activity and 10 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397782|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Year 2|"The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397783|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Year 2|"The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397784|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Year 2|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein.~The study was terminated before the 2–year time point was reached due to lack of clinical efficacy."|Baseline and Year 2|Analysis not performed.||||||
1397785|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 52|"The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1397846|NCT01285076|Secondary|Fear of Weight Gain Questionnaire|Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt).|1 year (during the 12-month period prior to the encounter visit)|The population analyzed only includes participants with available data.|||Percentage of participants|||Number
1397786|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
1397787|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 52|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 52|Apremilast participants as randomized/transitioned (AAR Population); population consists of all participants who were randomized or transitioned to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1397788|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 52|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 52|Apremilast participants as randomized during the apremilast exposure period.|||percentage of participants||95% Confidence Interval|Number
1397789|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
1397790|NCT01285310|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1397791|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 52|The Apremilast Participants as Randomized/ Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
1397792|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 52|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
1397793|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
1402100|NCT01246206|Primary|Safety Defined by Serious Adverse Events|Counted the number of participants that experienced any type of grade 3 or higher toxicity.|Assessed first 6 months post transplant||||participants|||Number
1397794|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 52|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
1397795|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 52|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
1397796|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 52|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
1397797|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 52|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included..|||percent change||Standard Deviation|Mean
1397798|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 52|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percent change||Standard Deviation|Mean
1397799|NCT01285310|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP at Week 52|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject’s global assessment of disease activity (SGA).~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1397800|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS),, where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
1397801|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 52|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1397847|NCT01285076|Secondary|Experience of Weight Gain Questionnaire|Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms[kg]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded.|1 year (during the 12-month period prior to the encounter visit)|The population analyzed includes only participants with available data.|||Percentage of participants|||Number
1398037|NCT01282424|Secondary|Pharmacokinetic (PK) Parameter: Cmax|Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29|PK Analysis Set: Participants enrolled in the PK substudy were analyzed.|||ng/mL||Standard Deviation|Mean
1397802|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1397803|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1397804|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 52|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject's global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject's self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 52|"The Apremilast participants as Randomized/Transitioned (AAR) Population; participants with a Baseline value and a Week 52 value are included.~Reporting Groups"|||percentage of participants||95% Confidence Interval|Number
1397805|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 24|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 24|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1397806|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percentage of participants|||Number
1397807|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1397808|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1397848|NCT01285076|Secondary|Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II|This questionnaire measures a diabetic participant’s fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most).|6 months (during the 6-month period prior to the encounter visit)|The population analyzed includes only participants with available data.|||Score on a scale||Standard Deviation|Mean
1397809|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397810|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 24|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397811|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397812|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 24|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397813|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 24|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397814|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 24|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397815|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 24|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397816|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 24|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percent change||Standard Error|Least Squares Mean
1397849|NCT01285076|Secondary|Experience of Low Blood Sugar (Hypoglycemia) Questionnaire|The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale.|6 months (during the 6-month period prior to the encounter visit)|All enrolled participants.|||Participants|||Number
1398038|NCT01282424|Secondary|Idelalisib Plasma Concentration||Predose and at 1.5 hours (± 5 minutes) postdose on Day 29||||ng/mL||Standard Deviation|Mean
1397817|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) Using CRP at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject's Global Assessment of Disease Activity.~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1397818|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||percentage of participants|||Number
1397819|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 24|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity.The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1397820|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1397821|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 24|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR 70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.|||percentage of participants|||Number
1397822|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 24|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR 50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 24|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 24.|||percentage of participants|||Number
1397850|NCT01285076|Secondary|Number of Adherence Days on the Self-reported Adherence Questionnaire|The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence).|7 days (during the 7-day period prior to the encounter visit)|All enrolled participants.|||Days||Standard Deviation|Mean
1398039|NCT01282424|Secondary|Study Drug Exposure|The average idelalisib exposure was summarized.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set|||months||Standard Deviation|Mean
1397823|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 70% Improvement (ACR 70) Response at Week 16|"Percentage of participants with an American College of Rheumatology 70% Improvement (ACR70) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 16|Full Analysis Set = The FAS consisted of all participants who were randomized as specified per protocol during the placebo controlled period. The last observed joint assessment (at baseline or post-baseline) was used for joints unassessed at Week 16.|||percent of participants|||Number
1397824|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 50% Improvement (ACR 50) Response at Week 16|"Percentage of participants with an American College of Rheumatology 50% Improvement (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index [(HAQ-DI)]); C-Reactive Protein."|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1397825|NCT01285310|Secondary|Percentage of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Week 16|"EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease.~Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2"|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1397826|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 4 Units From Baseline in the Functional Assessment of Chronic Illness Therapy –Fatigue (FACIT-Fatigue) at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percentage of participants|||Number
1397827|NCT01285310|Secondary|Percentage of Participants Who Achieve an Improvement of ≥ 0.22 Units From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
1397828|NCT01285310|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1397829|NCT01285310|Secondary|Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 16|"The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject’s blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly.~The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1397830|NCT01285310|Secondary|Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at Week 16|"C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific marker for disease."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1397831|NCT01285310|Secondary|Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1397832|NCT01285310|Secondary|Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at Week 16|"The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject’s current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Error|Least Squares Mean
1397833|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at Week 16|"The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents  lowest disease activity, and the right-hand boundary (score = 100 mm) represents  highest disease activity. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1397834|NCT01285310|Secondary|Percentage Change From Baseline in the Subject Assessment of Pain at Week 16|"The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1397835|NCT01285310|Secondary|Percentage Change From Baseline in the Swollen Joint Count at Week 16|Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1397836|NCT01285310|Secondary|Percentage Change From Baseline in the Tender Joint Count at Week 16|Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
1397837|NCT01285310|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Using C-Reactive Protein) (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC28)~28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Subject’s global assessment of disease activity (SGA )~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity.~A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1397838|NCT01285310|Secondary|Percentage of Participants Who Achieve Low Disease Activity or Remission Based on the Clinical Disease Activity Index (CDAI) ≤ 10 at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||percentage of participants|||Number
1397851|NCT01285076|Secondary|Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life.|1 day (the day of the encounter visit)|All enrolled participants.|||Score on a scale||Standard Deviation|Mean
1397839|NCT01285310|Secondary|Change From Baseline in the Clinical Disease Activity Index (CDAI) at Week 16|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:~28 tender joint count (TJC),~28 swollen joint count (SJC),~Subject’s Global Assessment of Disease Activity measured on a 100 mm visual analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest;~Physician's Global Assessment of Disease Activity -measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI:~Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22"|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1397840|NCT01285310|Secondary|Change From Baseline in the Medical Outcome Study Short Form 36-item (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The concepts measured by the SF-36 are not specific to any age, disease, or treatment group, allowing comparison of relative burden of different diseases and the relative benefit of different treatments. Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1397841|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Deviation|Mean
1397842|NCT01285310|Secondary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 24|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein"|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1397843|NCT01285310|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 post-baseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1397844|NCT01285310|Primary|Percentage of Participants With an American College of Rheumatology 20% Improvement (ACR 20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% Improvement (ACR 20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: Subject’s assessment of pain (measured on a 100 mm visual analog scale [VAS]); Subject’s global assessment of disease activity (measured on a 100 mm VAS); Physician's global assessment of disease activity (measured on a 100 mm VAS); Subject’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index ([HAQ-DI]); C-Reactive Protein."|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1397845|NCT01285076|Secondary|Self-reported Barrier Questionnaire|The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month.|30 days (during the 30-day period prior to the encounter visit)|All enrolled participants.|||Participants|||Number
1397901|NCT01284140|Secondary|Normal Circadian Timing|The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups.|Day 3|Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.|||Participants|||Count of Participants
1397852|NCT01285076|Secondary|Score on the Quality of Life (EQ-5D) Questionnaire|The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best).|1 day (the day of the encounter visit)|The population analyzed includes only participants with available data.|||Score on a scale||Standard Deviation|Mean
1397853|NCT01285076|Primary|Number of Participants With Hypoglycemic Episodes|Participants self-reported hypoglycemic (low blood sugar) episodes.|6 months|All enrolled participants.|||participants|||Number
1397854|NCT01285076|Primary|Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%|HbA1c is measured as a percent.|6 months|The population analyzed includes only participants with available data.|||participants|||Number
1397855|NCT01285050|Primary|HCV RNA|HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg.|48 hours after interferon administration||||log IU/ml||Inter-Quartile Range|Median
1397856|NCT01285024|Secondary|Total Hemoglobin Level Change|Total hemoglobin level change from preop to postoperative discharge.|day of surgery - 1 week postoperative||||g/dL||Standard Deviation|Mean
1397857|NCT01285024|Primary|Transfusion Requirement|Measure Title: Units of transfusion required|intraoperative - 1 week postoperative||||units||Standard Deviation|Mean
1397858|NCT01284959|Secondary|Assessment of Cognitive Functioning-3|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included Wisconsin Card-Sorting Test (WCST). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.~Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Trials to complete first category trials is 0, Maximum is 128 and minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after th"|baseline and 50hr after third medication||||trials||Standard Deviation|Mean
1397859|NCT01284959|Secondary|Assessment of Cognitive Functioning-2|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included the Stroop test, Trail-Making Test B (TMT B). All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications Minimum of Stroop test is 0, no maximum limit, the higher number is worse outcome.~Minimum of Trail making test B is 0 and no maximum limit, the higher number is worse outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication||||milliseconds||Standard Deviation|Mean
1397860|NCT01284959|Secondary|Symptoms Assessment by Objective Rating Scales|SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) Minimum of NIDSS is -3, maximum of NIDSS is +3. '+' is better outcome, '-' is worse outcome. Minimum of SNAS-Global score is 0, Maximum of SNAS-Global score is 5 The higher number is worse outcome. The zeros are measured and Calcuated value. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication||||units on a scale||Standard Deviation|Mean
1397861|NCT01284959|Secondary|Assessment of Cognitive Functioning-1|"CNT(Computerized Neuro-Cognitive Function Test System); The tests included a word fluency test. All of the assessments except the CNT were conducted immediately prior to administration of the medication and at 2 (for risperidone and placebo) or 24 h (for paliperidone ER) after the first and third administrations of the study medications.~Minimum of Wisconsin card sorting test-Category completed is 0, Maximum is 6, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative response and Trials to complete is 0, Maximum is 128, the lower number is worse outcome.~Minimum of Wisconsin card sorting test-Perseverative error is 0, Maximum is 128, the higher number is worse outcome.~Minimum of Word-fluency test is 0 and no maximum value, the higher number is better outcome.~The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication."|baseline and 50hr after third medication||||scores on a scale||Standard Deviation|Mean
1397862|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS is 0, Maximum is 10 Minimum of DIEPSS is 0, Maximum is 4 The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 50hr after third medication.|baseline and 50hr after third medication||||units on a scale||Standard Deviation|Mean
1397863|NCT01284959|Secondary|Assessment of Adverse Events by Objective Rating Scales and Self Report Scales|"DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert–drowsy, muzzy–clear headed, mentally slow–quick witted, attentive–dreamy), physical sedation (strong–feeble, well coordinated–clumsy, lethargic–energetic, incompetent–proficient), tranquilization (calm–excited, contented–discontented, troubled–tranquil, tense–relaxed), and other types of feelings (happy–sad, antagonistic–amicable, interested–bored, withdrawn–gregarious) Minimum of VAS(Mental sedation score,Physical sedation score,Total score) is 0, Maximum is 10.~VAS-total score is average of all subscale scores. Minimum of DIEPSS is 0, Maximum is 4. The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication||||units on a scale||Standard Deviation|Mean
1398240|NCT01280903|Secondary|Pain by the Bodily Pain Subscale of the Short Form-36v2 at 52 Weeks|Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1397864|NCT01284959|Primary|Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales|"SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total.~Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication."|baseline and 2hr after third medication||||units on a scale||Standard Deviation|Mean
1397865|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum Triglyceride Levels|A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||mmol/l||Standard Deviation|Mean
1397866|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio|A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||change in ratio||Standard Deviation|Mean
1397867|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels|A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||mmol/l||Standard Deviation|Mean
1397868|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels|A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||mmol/l||Standard Deviation|Mean
1397869|NCT01284634|Secondary|Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels|A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.|Baseline to EOT (Day 57) or ET|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||millimole (mmol)/l||Standard Deviation|Mean
1397870|NCT01284634|Primary|Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels|Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.|Baseline to EOT (Day 57) or Early Termination (ET)|ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.|||percentage change||Standard Deviation|Mean
1397871|NCT01284621|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Tolerability|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From drug administration until end of washout period (36 days)|Treated set which included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
1397872|NCT01284621|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/Fss)|Apparent volume of distribution at steady-state during the terminal phase λz following an extravascular dose.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
1397873|NCT01284621|Secondary|Apparent Clearance After Extravascular Administration (CL/Fss)|Apparent clearance of the analyte in plasma after extravascular administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1397874|NCT01284621|Secondary|Mean Residence Time (MRTpo,ss)|Mean residence time of the analyte in the body after oral administration at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Geometric Coefficient of Variation|Geometric Mean
1397875|NCT01284621|Secondary|Terminal Half-life (T 1/2,ss)|Terminal half-life of the analyte in plasma at steady-state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Geometric Coefficient of Variation|Geometric Mean
1397876|NCT01284621|Secondary|Terminal Rate Constant (λz,ss)|Terminal rate constant in plasma at steady-state|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1397877|NCT01284621|Secondary|Time From Last Dosing to the Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Full Range|Median
1397878|NCT01284621|Secondary|Ramiprilat: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|"Predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramiprilat.~Note, predose concentrations for ramipril were all below the limit of quantification (BLQ) and therefore the predose concentration of the analyte in plasma prior to administration of the Nth dose, of ramipril was not analysed."|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1397879|NCT01284621|Secondary|Empa: Predose Concentration Prior to Administration of the Nth Dose (Cpre,N)|Predose concentration of the analyte in plasma prior to administration of the Nth dose, of empagliflozin.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1397880|NCT01284621|Primary|Total Ramiprilat: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramiprilat.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1397881|NCT01284621|Primary|Total Ramiprilat: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramiprilat (active metabolite of ramipril).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1397882|NCT01284621|Primary|Total Ramipril: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1397883|NCT01284621|Primary|Total Ramipril: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss).|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of ramipril.|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1397884|NCT01284621|Primary|Total Empa: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval, τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1398289|NCT01280604|Primary|Triglyceride Levels|Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
1397885|NCT01284621|Primary|Total Empa: Area Under the Curve at Steady-state Over a Uniform Dosing Interval (AUCτ,ss)|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ, of empagliflozin (empa).|0 hours (h), 20 minutes (min), 40 min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration on day 5. In addition pre-dose samples, 5 minutes predose, were collected on days 1 to 4|Pharmacokinetic (PK) set: All subjects who took at least one dose of investigational treatment and provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1397886|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
1397887|NCT01284517|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
1397888|NCT01284517|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline to week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
1397889|NCT01284504|Secondary|Surveys to Evaluate Patient Pain, Fatigue, and Quality of Recovery, Recorded From Day of Surgery to 30 Days Post-op.||30 days|One patient was accrued and withdrawn after signing consent; none were treated.||||||
1397890|NCT01284504|Primary|Blood Samples Taken Before Initiation of Study, Day of Surgery, Days 1 and 3 Post-op, and 30 Days Post-op. Analyzed for 50 Serum Cytokines, Cell-specific Gene Expression, and TCR Repertoire.||30 days|One patient was accrued and withdrawn after signing consent; none were treated.||||||
1397891|NCT01284504|Primary|Tumor Sample - Analyzed for TCR Repertoire and Global Transcription Profiling||2 years|One patient was accrued and withdrawn after signing consent; none were treated.||||||
1397892|NCT01284491|Primary|Scar Quality|The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions.|0-18 months following breast reduction surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1397893|NCT01284426|Primary|Duration of Urticaria Until Remission Since Chronic Urticaria Was Diagnosed.|"Remission rates at 1, 3 and 5 years after the onset of symptoms of chronic urticaria.~Description in details:~Actually, this study have been started in March 2003 and finally done in March 2009, which would be totally 6 years. We eventually decided to report the rate of CU remissions only at 1, 3 and 5 years after the onset of symptoms because this would be the common interval time of CU symptoms that patients needed to know how long they should have those CU symptoms or how many of them would go away their symptoms within 1, 3 or 5 years. Another reason is that the remission rate of CU between 5 and 6 years was not significantly different, so it might not need to be reported."|6 years|Children 4-15 years old with chronic urticaria|||percentage of participants|||Number
1397894|NCT01284361|Secondary|Assessment of Ease of Use Characteristics|"Ease of insertion, removal, and control while catheterizing were assessed using a 5 point Likert scale. The numbers recorded are the percentage of the top two responses on a 5 point Likert scale. On one scale this includes 1) Very Easy or 2) Easy, on a scale ranging from 1) Very Easy to 5) Very Difficult. On the other scale this includes 1) Strongly Agree or 2) Agree on a scale ranging from 1) Strongly Agree to 5) Strongly Disagree."|1 week|82 self-catheterizing wheelchair-using men|||percentage of participants|||Number
1397895|NCT01284361|Primary|Percentage of Participants|Percentage of participants that preferred the 40 cm catheter|1 week||||percentage of participants|||Number
1397896|NCT01284296|Primary|Categorical Groups Based on Magnitude of Differences Between Noninvasive (SpHb) and Laboratory Co-Oximeter (tHb) Hemoglobin in Patients With a Finger Regional Anesthetic Block.||A minimum of 2-4 differences recorded approximately hourly during surgery||||percentage of hemoglobin readings|Participants||Number
1397897|NCT01284244|Primary|A 50% Reduction in Pad Test Weight|"A pad test is an objective measure of urine loss. With a full bladder, while wearing a pad, the participant completes five repetitions of the following physical activities: coughing, step climbing, heel bounce, standing from a sitting position and walking 50 yards. The weight of the pad is then determined.~The primary outcome variable will be the achievement of a 50% reduction in the pad weight before and after device placement. This figure is obtained from the study by Farrell et al, where pad weight decreased from 20 grams to 9 grams with the use of the Uresta device."|Immediately after device placement (short term).||||Participants|||Count of Participants
1397898|NCT01284140|Secondary|Delirium|The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups.|Day 3|Subjects still on study in the ICU on Day 3.|||Participants|||Count of Participants
1397899|NCT01284140|Secondary|Spectral Edge Frequency 95%|The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups.|Day 2|Polysomnography was not conducted on any participants due to logistical constraints.||||||
1397900|NCT01284140|Secondary|Circadian Amplitude|The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups.|Day 3|Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.|||percent of 24-hour mean 6-sulfatoxymelat||Standard Deviation|Mean
1397902|NCT01284140|Primary|Circadian Timing|The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1).|Day 1 to Day 3|Subjects with 24-hour 6-sulfatoxymelatonin excretion profiles from both Day 1 and Day 3.|||hours|||Number
1397903|NCT01284114|Primary|The Change of Urine Albumin/ Creatinine Ratio (UACR).|The UACR was measured at baseline, Week12 and Week24|baseline and 6 months|We analyzed all patients who completed this study.|||mg/g||Standard Deviation|Mean
1397904|NCT01284114|Primary|The Change of eGFR|eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73 m2) = 194 × age-0.287 × serum creatinine-1.094 (multiplied by 0.739 for females).|baseline and 6 month|We analyzed all patients who completed study.|||mL/min/1.73m2||Standard Deviation|Mean
1397905|NCT01284114|Secondary|The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM||6 months|||||||
1397906|NCT01284114|Primary|The Change of BNP|Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6month|We analyzed all patients who completed study.|||pg/ml||Standard Deviation|Mean
1397907|NCT01284114|Primary|The Change of Heart Function Confirmed by Echocardiograph|Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month. Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.|baseline and 6 month|We analyzed participants who copmleted this study|||% of stroke vulume/enddiastolic volume||Standard Deviation|Mean
1397908|NCT01284114|Primary|The Change of Blood Pressure|The change of systolic blood pressure and diastolic blood pressure|baseline and 6 month|We analyzed all patients who completed study.|||mmHg||Standard Deviation|Mean
1397909|NCT01284062|Secondary|Number of Participants With Change From Baseline in Endoscopic Subscore at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Endoscopy or flexible sigmoidoscopy is a sub score of Mayo score. The score for endoscopic subscore ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for endoscopy or flexible sigmoidoscopy at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||participants|||Number
1397910|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Rectal Bleeding at Week 14|Mayo score is used to measure the disease activity of ulcerative colitis. Rectal bleeding is a sub score of Mayo score. The score for rectal bleeding ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for rectal bleeding at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||participants|||Number
1397911|NCT01284062|Other Pre-specified|Number of Participants With Change From Baseline in Stool Frequency at Week 14|Stool frequency is a sub score of Mayo score used to measure the disease activity of ulcerative colitis. The score for stool frequency ranges from 0 to 3, where higher score indicates more severe disease activity. Participant’s score for stool frequency at Week 14 was specified as improved (decrease), no change and worsened (increase) compared to their baseline score.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||participants|||Number
1397912|NCT01284062|Other Pre-specified|Change From Baseline in Total Mayo Score at Week 14|The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Baseline, Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||unit on a scale||95% Confidence Interval|Least Squares Mean
1397913|NCT01284062|Other Pre-specified|Clinical Remission Rate at Week 14|Clinical remission rate is defined as percentage of participants with a total Mayo score less than or equal to 2, with no individual subscore greater than 1 at post baseline visit. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||percentage of participants||95% Confidence Interval|Number
1397925|NCT01284062|Secondary|Maximum Observed Plasma Concentration (Cmax) for Anrukinzumab|Maximum concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable pharmacokinetic (PK) results were included in PK population. PK samples with time deviation greater than (>) 20 percent (%) from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” = participants in PK population; n = evaluable participants at specified time point."|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1398450|NCT01277861|Primary|Movement|The data provided below include participants who moved (includes all grades of movement ie, mild, moderate and severe).|Induction of Anesthesia|Per protocol|||Participants, number|||Number
1397914|NCT01284062|Other Pre-specified|Clinical Response Rate at Week 14|Clinical response rate is defined as percentage of participants with at least 3 point decrease from baseline in total Mayo score with at least 30% change along with 1 point decrease from baseline or absolute score of 0 or 1 in rectal bleeding. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy [endoscopy] and physician’s global assessment), each subscore is graded from 0 to 3 with the higher score indicating more severe disease activity.|Week 14|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||percentage of participants||95% Confidence Interval|Number
1397915|NCT01284062|Secondary|Number of Participants With Anti-drug Antibody (ADA) and Neutralizing Antibody|Neutralizing antibody was not analyzed as no participant had positive ADA samples.|Day 1, Week 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.|||participants|||Number
1397916|NCT01284062|Secondary|Number of Participants Who Discontinued From the Study Due to Adverse Events||Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1397917|NCT01284062|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 32 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial.|Baseline up to Week 32|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
1397918|NCT01284062|Secondary|Total Interleukin-13 (IL-13) Level||Baseline, Day 2, 4, 7, Week 2, 4, 8, 12, 14, 16, 20, 24, 28, 32|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.|||picogram/milliliter||Standard Deviation|Mean
1397919|NCT01284062|Secondary|Fold Change From Baseline in Fecal Calprotectin at Week 2, 4, 8 and 12|The fold change from baseline in fecal calprotectin at post-baseline visit, is the ratio of the measurement of fecal calprotectin at post-baseline visit to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at post-baseline visit.|Baseline, Week 2, 4, 8, 12|mITT: all randomized participants who received >=1 dose study drug; DAO: all mITT participants with all data needed for calculation of specified endpoint. “Number of Participants Analyzed” signifies participants in mITT population; “n” signifies participants in mITT DAO population for specified time point.|||fold change||95% Confidence Interval|Least Squares Mean
1397920|NCT01284062|Secondary|Volume of Distribution (Vz) for Anrukinzumab|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||liters||Standard Deviation|Mean
1397921|NCT01284062|Secondary|Systemic Clearance (CL) for Anrukinzumab|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||liters/day||Standard Deviation|Mean
1397922|NCT01284062|Secondary|Plasma Decay Half-Life (t1/2) for Anrukinzumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Within 1 hour post-end of infusion on Week 12; Week 14, 16, 18, 20, 22, 24, 26, 28, 30, 32|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||hours||Standard Deviation|Mean
1397923|NCT01284062|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Anrukinzumab|Area under the plasma concentration curve from time zero to end of dosing interval (2 weeks) was reported.|Pre-dose, within 1 hour post-end of infusion on Day 1; Day 2, 4, 7, pre-dose on Week 2|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1397924|NCT01284062|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for Anrukinzumab|Lowest concentration observed during the dosing interval (2 weeks for day 1, 4 weeks for week 12).|Pre-dose to end of the dosing interval after Day 1, Week 12|"All participants with evaluable PK results were included in PK population. PK samples with time deviation >20% from nominal time were excluded from statistical summary and PK analysis. “Number of participants analyzed” signifies participants in PK population; n signifies evaluable participants at specified time point."|||ng/mL||Standard Deviation|Mean
1399057|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in Cohort 1A in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were BRAFi-naïve participants.|||mcg/mL||Standard Deviation|Mean
1397926|NCT01284062|Primary|Fold Change From Baseline in Fecal Calprotectin at Week 14|The fold change from baseline in fecal calprotectin at Week 14, is the ratio of the measurement of fecal calprotectin at Week 14 to baseline measurement; this was calculated as the change from baseline in natural log transformed fecal calprotectin at Week 14.|Baseline, Week 14|Modified Intent to Treat (mITT: all randomized participants who received greater than or equal to [>=] 1 dose study drug); Data as Observed (DAO: all mITT participants with all data needed for calculation of specified endpoint). “Number of Participants Analyzed” signifies participants in the mITT DAO population for specified endpoint.|||fold change||95% Confidence Interval|Least Squares Mean
1397927|NCT01283971|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Discontinuation Due to AEs and Deaths|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|32 weeks|Safety Population included all participants who received study drug and who had at least 1 post-dose safety assessment.|||Participants|||Number
1397928|NCT01283971|Secondary|Change From Baseline in Hemoglobin at Week 24|Blood was collected at Baseline and Week 24. The samples were sent to a central laboratory for Hemoglobin analysis reported in gram/deciliter (g/dL). A positive number change from Baseline (a higher hemoglobin level compared to Baseline) indicated improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with hemoglobin data available at Baseline and Week 24.|||g/dL||Standard Deviation|Mean
1397929|NCT01283971|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Week 24|RAPID3 is a patient self reported assessment that combines the HAQ-DI [20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions answered on a 4-point scale where 0=without any difficulty to 3=unable to do} converted to a score of 0-10, the Patients Assessment of Pain [Over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain] converted to a score of 0-10 and the Patient's Global Assessment of Disease Activity [over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity] converted to a score of 0-10. The 3 individual scales are summed for a raw score of 0-30 which is divided by 3 to achieve a total possible adjusted score of 0-10. A negative change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1397930|NCT01283971|Secondary|Change From Baseline in Quality of Life Short Form (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||Score on a scale||Standard Deviation|Mean
1397931|NCT01283971|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
1397932|NCT01283971|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
1397933|NCT01283971|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 24|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeter/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||mm/hr||Standard Deviation|Mean
1402101|NCT01246206|Primary|Incidence of Acute GVHD|Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks|Assessed first 6 months post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1397934|NCT01283971|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 24|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The concentration of CRP was measured in milligram/liter (mg/L). A reduction in the level is considered an improvement|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24 for this outcome measure.|||mg/L||Standard Deviation|Mean
1397935|NCT01283971|Secondary|Change From Baseline in the Physician Global Assessment of Disease Activity VAS at Week 24|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
1397936|NCT01283971|Secondary|Change From Baseline in the Patient Global Assessment of Disease Activity VAS at Week 24|"The patient's global assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
1397937|NCT01283971|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 24|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24.|||Score on a scale||Standard Deviation|Mean
1397938|NCT01283971|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation carried forward was used to impute missing tender joint counts.|||Joint count||Standard Deviation|Mean
1397939|NCT01283971|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment. Last observation was used to impute missing swollen joint counts.|||Joint count||Standard Deviation|Mean
1397940|NCT01283971|Secondary|Change From Baseline in DAS28 Score at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.|||Score on a scale||Standard Deviation|Mean
1397941|NCT01283971|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. LDAS is defined as DAS28 ≤3.2.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other DAS28 components were used as observed.|||Percentage of participants|||Number
1397942|NCT01283971|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) DAS28 Responses at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total score ranges from 0 (best) to 10 (worst). A negative change from Baseline indicated improvement. European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other EULAR components were used as observed.|||Percentage of participants|||Number
1397954|NCT01283555|Secondary|Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if there were any reasons that they would not want to use this user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397943|NCT01283971|Secondary|Percentage of Participants With ACR70 Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
1397944|NCT01283971|Secondary|Percentage of Participants With ACR50 Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
1397945|NCT01283971|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with ACR score data available. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
1397946|NCT01283971|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. DAS28 Remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug and had at least 1 post-baseline efficacy assessment, with data available at Baseline and Week 24. Last observation carried forward was used to impute missing tender and swollen joint counts. All other ACR components were used as observed.|||Percentage of participants|||Number
1397947|NCT01283581|Secondary|Clinical Response Rate in Subjects With Infections Caused by MRSA||up to Late Follow-up|||||||
1397948|NCT01283581|Secondary|Microbiological Response Rate in All Subjects and in Subjects With Infections Caused by MRSA||up to Late Follow-up|||||||
1397949|NCT01283581|Secondary|The Levels of Biochemical Markers of Inflammation||on Days 1, 5, Follow-up, and late Follow-up|||||||
1397950|NCT01283581|Secondary|Steady State Pharmacokinetic Parameters in Subjects Administered Delafloxacin, Vancomycin, and Linezolid||Through Day 3 (± 1 day)|||||||
1397951|NCT01283581|Secondary|Erythema Clinical Success|The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.|48 - 72 hours|ITT (intent-to-treat) population, defined as all subjects who were randomized.|||Participants|||Number
1397952|NCT01283581|Primary|Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up and Late Follow-up.|The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.|Follow-up (Day 14 ± 1) and late follow-up (Day 21-28)|ITT (intent-to-treat) population, defined as all subjects who were randomized.|||Participants|||Number
1397953|NCT01283555|Secondary|Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention|"Participants were asked if they would recommend the user-filled applicator to other women if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397985|NCT01283321|Secondary|Volume (mL) of Platelets Transfused- During Surgery and up to 24 Hours After Surgery||Operative period up to 60 minutes and up to 24 hours after surgery||||ml||Inter-Quartile Range|Median
1397955|NCT01283555|Secondary|Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention|"Participants were asked if they would use the user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397956|NCT01283555|Primary|Number of Colposcopic Findings (Baseline and After One Week of Product Use)|Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator|7 days|The number of participants for analysis was determined by counting the number of participants with colposcopic findings and baseline and after one week of product use.|||colposcopic findings|Participants||Number
1397957|NCT01283555|Secondary|Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator|"Participants were asked if the cost of the applicator would influence their choice of applicator.~Response categories were yes, no, and maybe."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397958|NCT01283555|Secondary|Number of Participants Reporting That Both Applicators Were Acceptable|"Participants were asked if both applicators were acceptable to them. Responses were either yes or no."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397959|NCT01283555|Secondary|Number of Participants Reporting That the Instructions for Use Were Helpful|"For each applicator type, participants were asked if the instructions were helpful to you.~Response categories were yes and no."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397960|NCT01283555|Secondary|Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort|"Participants were asked if they could suggest ways that would make each applicator easier or more comfortable to use. Response categories were yes and no. If yes, participants were asked to describe how they would make the applicator easier and/or more comfortable to use."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397961|NCT01283555|Secondary|Number of Participants Reporting That Applicator Was Comfortable to Use|"Participants were asked to describe the comfort of use for each applicator type(user-filled and prefilled).~Response categories included comfortable, neutral, and uncomfortable."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397962|NCT01283555|Secondary|Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors|"Participants were asked about their preference for either the user-filled or prefilled applicator with regard to several use factors as well as in relation to disposal, storage, and overall comfort and preference.~Response categories included user-filled, prefilled, and same."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||responses|||Number
1397963|NCT01283555|Secondary|Number of Participants Reporting That the Gel Was Easy to Dispense|"Participants were asked to describe the dispensing of the gel into the vagina with each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397964|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Insert|"Participants were asked to describe the insertion of the applicator into the vagina for each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397965|NCT01283555|Secondary|Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly|"Participants were asked how did they know when the applicator was filled correctly (that is, with the right amount of gel). More than one answer was allowed.~Response categories included plunger automatically stopped, the 'FULL' line was reached, and other.~Note: this question does not apply to the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis. Each participant could identify multiple reasons. As a result, the number of units analyzed is greater than the number of participants.|||participants|Participants||Number
1397966|NCT01283555|Secondary|Number of Respondents Reporting Confidence With Filling the User-filled Applicator|"Participants were asked when using the user-filled applicator, how confident did they feel that they at inserted the correct amount of gel into the applicator.~Response categories included very confident, confident, and not confident.~(Note: this question does not apply to the prefilled applicator.)"|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397967|NCT01283555|Secondary|Number of Participants Reporting Applicator Easy to Fill|"Participants were asked to describe the process of filling the user-filled applicator.~Response categories included easy, moderately difficult, and difficult.~Since ease of filling only applies to the user-filled applicator, this question was not applicable for the prefilled applicator."|Final study visit (after completing both study arms)|All participants were included in the analysis.|||participants|||Number
1397968|NCT01283555|Secondary|Dosing Accuracy (% of Target Dose Delivered)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The average dose delivered for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||percent of target dose delivered|Participants||Number
1397969|NCT01283555|Secondary|Dosing Precision, 10% (Expressed Volume)|A 10% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
1397970|NCT01283555|Secondary|Dosing Precision, 5% (Expressed Volume)|A 5% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
1397971|NCT01283555|Secondary|Dosing Volume (Expressed Volume)|At each dose delivery visit, the applicator was weighed prior to vaginal insertion and after use. The volume of gel expressed was measured using the following data: weight of filled applicator, weight of emptied applicator, the average weight of an empty applicator, and gel density.|3 dose delivery measurements during 1 week of product use|Per protocol, all participants were included in the analysis.|||ml|Participants|Standard Deviation|Mean
1397972|NCT01283555|Secondary|Filling Accuracy (% of Target Dose)|The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The filled volume for each applicator was compared with the intended target dose of 4.0ml.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||% of target dose filled into applicator|Participants||Number
1397973|NCT01283555|Secondary|Filling Precision (10% Range)|A 10% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-10% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
1397974|NCT01283555|Secondary|Filling Precision (5% Range)|A 5% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-5% of average volume)|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||doses|Participants||Number
1397975|NCT01283555|Secondary|Filled Volume|At each dose delivery visit, the applicator was weighed, prior to vaginal insertion. For the user-filled applicator, the participant handed the applicator to the investigator after filling with gel from the multidose tube. The applicator was then weighed and returned to the participant for insertion. For the prefilled applicator, the participant inserted the plunger into the barrel, and then handed the applicator to the investigator for weighing.|3 dose delivery measurements during 1 week of product use|Per protocol all participants were included in the analysis.|||ml|Participants|Standard Deviation|Mean
1397976|NCT01283516|Primary|Duration of Response (DOR) Based on Investigator Assessment|As per Kaplan-Meier estimate. Duration of response (DOR) is defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.|33 months|Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and received prior crizotinib and had a confirmed overall complete response or partial response after initiation of LDK378.|||Months||95% Confidence Interval|Median
1397977|NCT01283516|Primary|Overall Response Rate (ORR) Based on Investigator Assessment|Overall response rate (ORR) is defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).|33 months|Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and received prior crizotinib|||Percentage of Participants||95% Confidence Interval|Number
1397978|NCT01283516|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.|33 months|Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.|||Participants|||Number
1397979|NCT01283516|Secondary|Absorption and Plasma Concentrations of LDK378||120 weeks||2017-05-31|05/2017||||
1397980|NCT01283516|Secondary|Type and Category of Study Drug Related Adverse Events||120 weeks||2017-05-31|05/2017||||
1397981|NCT01283464|Primary|Global Photodamage Severity|A photonumeric scale for the assessment of cutaneous photodamage (CE Griffiths, et al). Five photographic standards (en face and 45 degrees oblique) illustrating increasing severity of photodamage (min=0, max=8) where 0=no damamge; 2=mild damage; 4=moderate damage; 6=moderate/severe damage; and grade 8=severe damage.|Week 24||||units on a scale||Standard Deviation|Mean
1397982|NCT01283334|Secondary|Progression-free Survival (PFS)|Objective tumor responses were assessed every 2 cycles of chemotherapy with computed tomography or positron emission tomography/ computed tomography scans in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|The time of PFS was calculated as the time from study enrollment to the disease progression date, death date, or last contact, whichever came first, up to 25 months||||months||Full Range|Median
1397983|NCT01283334|Primary|To Measure the Safety and Clinical Effectiveness of the Combination of Carboplatin, Cetuximab and RAD001 in Patients With Advanced (Recurrent or Metastatic) Head and Neck Cancer|This phase 1 clinical trial used a standard 3 + 3 design. Four dose levels of everolimus were planned to be evaluated, and the standard 3 + 3 design with dose de-escalation was used in the trial. Namely, 3 patients were assigned to starting dose level 1. If no dose-limiting toxicity (DLT) was observed, the trial proceeded to the next dose level, and another cohort of 3 patients was enrolled. If at least 2 of the 3 patients experienced at least 1 DLT, then the dose level decreased; otherwise, if only 1 patient experienced DLT, then 3 more patients were enrolled at the same dose level. If none of the 3 additional patients experienced DLT, the dose was escalated; otherwise, the dose level decreased. Dose reduction continued until a dose level was reached at which 6 patients had been treated and at most 1 DLT was observed.|Within the first 21 days of therapy||||participants|||Number
1397984|NCT01283321|Secondary|Median Blood Loss (mL) at 12 Hours After Surgery||From end of surgery to 12 hours after surgery||||ml||Inter-Quartile Range|Median
1397988|NCT01283321|Primary|Bleeding Scores|Bleeding scores are scored on a four-point scale. A visual assessment of surgical field was performed by the senior surgical staff as follows: 0 = excellent hemostasis (dry field), 1 = mild bleeding (oozing), 2 = moderate bleeding (controllable with applied pressure), and 3 = severe bleeding (multiple diffuse bleeding sites). If the visual bleeding scale was 2 to 3, the subjects were randomly assigned to a study intervention using a closed envelope method.|intra-operatively and up to 24 hours postoperatively||||units on a scale||Standard Deviation|Mean
1397989|NCT01283282|Secondary|Inflammatory Marker CD40 Ligand|CD40 ligand levels were measured. The level of CD40 ligand were measured using the Flurokine MultiAnalyte profiling (MAP) Human Base Kit B.|Week 12||||pg/mL||Standard Error|Mean
1397990|NCT01283282|Secondary|Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)|High-sensitivity C-reactive protein (hsCRP) was measured. The hsCRP levels were measured by Dade Behring nephelometry.|Week 12||||mg/L||Standard Error|Mean
1397991|NCT01283282|Secondary|Oxidative Stress Markers|Oxidative stress was measured by using liquid chromatography to collect plasma cystine, cysteine, gluthione, and oxidized glutathione levels.|Week 12||||µM||Standard Error|Mean
1397992|NCT01283282|Secondary|Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in seconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Week 12||||m/s||Standard Error|Mean
1397993|NCT01283282|Primary|Endothelial Progenitor Cells (EPCs)|The circulating progenitor-enriched population of cells was measured by the expression of surface antigens using direct flow cytometry for CD34+, CD34+/CD133+, CD34+/ VEGF2R+ and CD34+/CD133+/VEGF2R+|Week 12||||cells/µL||Standard Error|Mean
1397994|NCT01283282|Primary|Nitroglycerin-mediated Vasodilation|Nitroglycerin (NTG)-mediated vasodilation was measured after 0.4 mg of NTG was administered sublingually. Brachial artery images were obtained via ultrasound after three minutes of NTG administration. Measurements from the twelve frames will be averaged to calculate the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12||||percent change in diameter||Standard Error|Mean
1397995|NCT01283282|Primary|Flow-mediated Dilation (FMD)|Flow-mediated dilation (FMD) collected by an ultrasound and is measured by the percent change in diameter of the brachial artery from baseline to 12 weeks.|Baseline, Week 12||||percent change in diameter||Standard Error|Mean
1397996|NCT01283152|Primary|Change in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited. HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study|||participants|||Number
1397997|NCT01283152|Secondary|Hospital Duration/Length of Stay||From time of admission to time of discharge or death||||days||Standard Deviation|Mean
1397998|NCT01283152|Primary|Number of Participants With an Improvement of 1 or More in HE Grade at 24 Hours|Hepatic Encephalopathy Scoring Algorithm (HESA) at the 24 hour time point of when the subject was recruited (HESA improvement by at least 1 grade). HESA ranges from 0 to 3, with higher numbers indicating a more severe grade of hepatic encephalopathy. Study will continue at every 24 hour time point until the subject achieves his or her baseline mental state and/or grade 0 based on the HESA|Baseline to 24 hours|All participants who completed the study|||participants|||Number
1397999|NCT01283139|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs|The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs.|Day 1 up to Week 56|The safety population included all participants who received any investigational product.|||participants|||Number
1398000|NCT01283139|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.|||participants|||Number
1398001|NCT01283139|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported.|Day 1 up to Week 61|The safety population included all participants who received any investigational product.|||participants|||Number
1398002|NCT01283139|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study.|Day 1 up to Week 74|The safety population included all participants who received any investigational product.|||participants|||Number
1398003|NCT01283139|Secondary|Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant’s response to the questions (with the exception of 2 negatively stated), greater was the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a FACIT-fatigue score <49 at baseline."|||percentage of participants|||Number
1398004|NCT01283139|Secondary|Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction|The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score >=10 at baseline who achieved a clinically significant (>=4-point) reduction at Day 365 were reported.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a CLASI activity score >=10 at baseline."|||percentage of participants|||Number
1398005|NCT01283139|Secondary|Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day|Percentage of participants on >=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to <=7.5 mg/day by Day 365 were recorded.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants on >=10 mg/day oral prednisone (or equivalent) at baseline."|||percentage of participants|||Number
1398006|NCT01283139|Primary|Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants|SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of >=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline).|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with positive diagnostic test."|||percentage of participants|||Number
1398007|NCT01283139|Primary|Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4])|SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points (with increased deoxyribonucleic acid [DNA] binding item of SLEDAI-2K score based on the ANA Multi−Lyte® ANA−II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new ‘A’ score or 2 new ‘B’ scores on the BILAG-2004 compared with baseline).|Day 365|The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement.|||percentage of participants|||Number
1398008|NCT01283035|Secondary|Toxicities of Akt Inhibitor MK2206, as Assessed by the Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)||Up to 3 years|Number of participants experiencing toxicities.|||participants|||Number
1398009|NCT01283035|Secondary|Duration of Progression-free Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
1398010|NCT01283035|Secondary|Duration of Overall Survival Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study|Distributions will be estimated using Kaplan-Meier analysis.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
1398011|NCT01283035|Secondary|Development of Feedback Loop Activation and Target Inhibition With Akt Inhibitor MK2206 Via Analysis of Pre-treatment and Post-treatment Biopsies in Select Patients Enrolled in the Trial||Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
1398012|NCT01283035|Secondary|Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 (as Assessed by Objective Tumor Response, Progression-free Survival, and Overall Survival)|The frequency of mutations in the PI3K/AKT and RAS pathways, copy number alterations, and PTEN loss and AKT expression as assessed by IHC will be tabulated. Associations between these markers with clinical outcome such as response rate and duration of PFS will be assessed.|Up to 3 years|Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.||||||
1398013|NCT01283035|Primary|Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer|"If 4 or more of the final set of 29 patients demonstrate a response, then the null hypothesis H0: =< 5% can be rejected in favor of the alternative hypothesis H1: >= 20% with an alpha of 0.05 and beta of 0.20 (i.e., 80% power).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|Up to 3 years|Five patients started study treatment.|||participants|||Number
1398014|NCT01283022|Primary|Maximum Plasma Concentration (Cmax) of Misoprostol up to 1 Hour Post Study Drug Removal|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.|||pg/mL||Standard Deviation|Median
1398015|NCT01283022|Secondary|Rate of Adverse Events.|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48-72 hours).|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.|||percentage of participants|||Number
1398016|NCT01283022|Primary|Time of Maximum Plasma Concentration (Tmax) of Misoprostol After Insertion|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 0.5,1, 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5 and 1 hour after removal of the study drug. The 10 hour and 14 hour blood samples were obtained if the subject still had the study drug in place at those timepoints.|From study drug insertion up to 1 hour post study drug removal.|The pharmacokinetic (PK) analysis included all 24 subjects from the Intention-to-Treat (ITT) population.|||hours||Standard Deviation|Median
1398017|NCT01282866|Secondary|Hair Count|"The hair at the treatment area is counted at Baseline and 15 months following the last treatment.~Hair clearance is determined by the percentage of Hair left 15 months following the last treatment compared to the hair number at baseline."|15 month following last treatment|The number of participants who completed 15 months follow up was 23 out of 35.|||percentage of hair clearance||Standard Deviation|Mean
1398018|NCT01282866|Secondary|Level of Comfort Associated With Treatment||Each treatment|||||||
1398019|NCT01282866|Secondary|Treatment Time|The treatment time was measured for each participant on each and every visit. The result is presented as mean of all treatment time from all of the visits and all of the participants.|Each treatment||||minutes||Standard Deviation|Mean
1398020|NCT01282866|Primary|Hair Count|"The hair at the treatment area is counted at Baseline and 6 months following the last treatment.~Hair clearance is determined by the percentage of Hair left 6 months following the last treatment compared to the hair number at baseline."|6 month following last treatment||||percentage of hair clearance||Standard Deviation|Mean
1398021|NCT01282814|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1398022|NCT01282814|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1398023|NCT01282814|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1398024|NCT01282801|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1398025|NCT01282801|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1398026|NCT01282801|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1398027|NCT01282801|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1398028|NCT01282801|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1398029|NCT01282801|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1398030|NCT01282723|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC, as Identified by Readers|The presence of contractions measured by the SureCALL®, the presence of contractions measured by the TOCO, and the presence of contractions measured by the IUPC were determined by independent Readers. The Odds Ratio of SureCALL® contractions to IUPC contractions was calculated, and the Odd Ratio of TOCO contractions to IUPC contractions was calculated. Reader Correspondence was determined by a General Linear Mixed Model.|9 - 42 Minutes||||Odds Ratio||95% Confidence Interval|Number
1398031|NCT01282710|Primary|Comparison of SureCALL® and TOCO Detection of Contraction Events, as Compared to the IUPC|Contraction timing as measured by the SureCALL® and contraction timing as measured by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of SureCALL® and TOCO were then compared.|9 - 42 Minutes||||Seconds||Standard Deviation|Mean
1398032|NCT01282476|Secondary|Toxicities|Evaluate safety of this combination in relapsed/refractory DLBCL patients Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening|1 year||||Participants|||Count of Participants
1398033|NCT01282476|Secondary|Progression-free Survival Rate|Progression is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).|6 months||||percentage of participants||90% Confidence Interval|Number
1398034|NCT01282476|Primary|Overall Response Rate|"Overall response rate is defined by the Revised International Workshop Response Criteria (2007) (see reference in protocol section).~Overall response (OR) = Complete response (CR) + Partial response (PR)"|1 year||||percentage of participants||90% Confidence Interval|Number
1398040|NCT01282424|Secondary|Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms|"This composite endpoint measured the safety and tolerability profile of idelalisib. Clinically meaningful abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator."|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set|||participants|||Number
1398041|NCT01282424|Secondary|Change in Karnofsky Performance Status|The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1398042|NCT01282424|Secondary|Change in Health-related Quality of Life|"Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline.~The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications."|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
1398043|NCT01282424|Secondary|Overall Survival|Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set|||months||95% Confidence Interval|Median
1398044|NCT01282424|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set|||months||95% Confidence Interval|Median
1398045|NCT01282424|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.|||months||Inter-Quartile Range|Median
1398046|NCT01282424|Secondary|Lymph Node Response Rate|Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1398047|NCT01282424|Secondary|Duration of Response|Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause.|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|Participants in the ITT Analysis Set who achieved a CR or PR (or MR for subjects with WM) were analyzed.|||months||Inter-Quartile Range|Median
1398048|NCT01282424|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of subjects achieving a complete response (CR) or partial response (PR; or minor response [MR] for subjects with Waldenström macroglobulinemia [WM]) as assessed by the study independent review committee (IRC).~CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.~PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.~For WM only, response was defined as a reduction in IgM of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; plus any reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)"|From enrollment until all subjects completed ≥ 24 weeks of evaluation (up to 24 months)|ITT Analysis Set: Enrolled participants who received at least one dose of study medication|||percentage of participants||95% Confidence Interval|Number
1398049|NCT01282372|Secondary|Mean Sleep Disturbance Subscale Score|The Medical Outcome Study (MOS) sleep scale was a 12-item, participant-reported, non-disease-specific measure related to sleep that yielded 7 subscales (4-item sleep disturbance, 2-item sleep adequacy, 1-item quantity of sleep, 3-item somnolence, 1-item snoring, 1-item shortness of breath, and 9-item overall sleep problems index). Only sleep disturbance subscale was assessed by calculating the average of the 4-items with total score ranging from 0 to 100 (higher scores indicating greater sleep disturbance). Data are presented as mean score on a scale +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using safety analysis set defined as all participants who received at least one dose of adalimumab.|||Scores on a scale||Standard Deviation|Mean
1398050|NCT01282372|Secondary|Mean Visual Analogue Scale (VAS) Score|The VAS score assessed by participants (pt) and physicians (ph) was used to determine the pain due to psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain). Data are presented as mean VAS score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available VAS score at the study time points.|||Scores on a scale||Standard Deviation|Mean
1398051|NCT01282372|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations were assessed to evaluate CRP, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean CRP value in milligrams per liter (mg/L) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.|||mg/L||Standard Deviation|Mean
1398052|NCT01282372|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations were assessed to evaluate ESR, a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies. Data are presented as mean ESR value in millimeters per hour (mm/hr) ± standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.|||mm/hr||Standard Deviation|Mean
1398053|NCT01282372|Secondary|Percentage of Participants With Tender Joint Count (TJC) and Swollen Joint Count (SJC) Greater Than Zero|"Joints (68 or 66) were assessed by pressure and joint manipulation on physical examination for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present (1), absent (0), replaced (9), or no assessment (NA). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively with higher scores indicated worse conditions. Data are presented as percentage of participants with TJC and SJC."|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with evaluable data at the study time points.|||Percentage of participants|||Number
1398054|NCT01282372|Secondary|Mean Psoriatic Arthritis Response Criteria (PsARC) Score|As the patient and physician global assessments were performed using a 0-100 VAS scale instead of the 5 point Likert scale, the PsARC score could not be calculated, although data on joint pain and swelling were collected. Hence, the psoriatic arthritis disease activity was evaluated by the percentage of patients with tender and swollen joints, acute phase reactants (ESR and CRP), and VAS Score (patient and physician). Data are reported under outcome measures 13 through 16.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The PsARC score was not assessed in this study.||||||
1398055|NCT01282372|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. The mean measurement (score) of questions 5 and 6 is added to the scores from questions 1 to 4 and divided by 5 to calculate the total BASDAI score. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), higher scores indicating severe disability due to AS disease. Data are presented as mean total BASDAI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available BASDAI score at the study time points.|||Scores on a scale||Standard Deviation|Mean
1398056|NCT01282372|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ-DI score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available HAQ-DI score at the study time points.|||Scores on a scale||Standard Deviation|Mean
1398057|NCT01282372|Secondary|Mean Disease Activity Score 28 (DAS28)|The DAS28, a combined index that measured rheumatoid arthritis disease activity, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); (4) erythrocyte sedimentation rate (ESR); and (5) C-reactive protein (CRP). The DAS28 scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28 scores indicate improvement of disease. The DAS28 score less than or equal to 2.6 is defined as clinical remission. Data are presented as mean DAS28 score +/- standard deviation.|Baseline (Day 1), Month 3, Month 6, Month 12, Month 18, and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available DAS28 score at the study time points.|||Scores on a scale||Standard Deviation|Mean
1398058|NCT01282372|Primary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398059|NCT01282372|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem by Disease Subgroups|The 'overall activity impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall activity impairment due to health problem' was calculated based on one item: (Q6) to what degree did the disease impair the ability to do regular activities in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398060|NCT01282372|Primary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398061|NCT01282372|Secondary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem by Disease Subgroups|The 'overall work impairment due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the disease impair the productivity while working past seven days from visit). The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398062|NCT01282372|Primary|Mean Change From Baseline in Impairment While Working Due to Health Problem|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398063|NCT01282372|Secondary|Mean Change From Baseline in Impairment While Working Due to Health Problem by Disease Subgroups|The 'impairment while working due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'impairment while working due to health problem' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398064|NCT01282372|Primary|Mean Change From Baseline in Work Time Missed Due to Health Problem|The 'work time missed due to health problem' was assessed using the Work Productivity and Activity Impairment-General Health Problem (WPAI-GHP) questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398065|NCT01282372|Secondary|Mean Change From Baseline in Work Time Missed Due to Health Problem by Disease Subgroups|The 'work time missed due to health problem' was assessed using the WPAI-GHP questionnaire. WPAI-GHP is a six-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of rheumatoid diseases (RA, PsA, and AS). The 'work time missed due to health problem' was calculated based on two items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit and (Q4) the number of actual work hours in the past seven days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline (Day 1) and Month 24|The analysis was performed using efficacy analysis set defined as all participants in the enrolled population with an available WPAI-GHP score at the study time points.|||Impairment percentage||Standard Deviation|Mean
1398066|NCT01282294|Secondary|Time to Full Weight Bearing|The time from surgery to full weight bearing was assessed in days.|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8). 3 patients never reached full weight bearing, and 1 dropped out before 6 weeks.|||days||Full Range|Median
1398117|NCT01282086|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||beats per minute||Standard Deviation|Mean
1398067|NCT01282294|Secondary|Patient's Perceived Satisfaction|Patient's perceived satisfaction was scored on a 100mm visual analog scale (VAS). A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|6 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~Patient satisfaction was completed by 84 patients."|||scores on a scale||Standard Deviation|Mean
1398068|NCT01282294|Secondary|Pain by Visual Analog Scale (VAS)|Leg pain intensity was rated on a 100-mm visual analog scale (VAS). A score of zero indicated no pain at all, and 100 represented the worst possible pain.|6 weeks, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398069|NCT01282294|Secondary|Likelihood to Develop a Non-union Assessed by Surgeon|The likelihood to develop a non-union was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398070|NCT01282294|Secondary|Likelihood to Develop Wound Infection Assessed by Surgeon|The likelihood to develop a wound infection was assessed by the surgeon on a scale from 0 to 100 (0 = almost nil, 100 = absolutely sure).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398071|NCT01282294|Primary|Infection Adverse Events|"Infections at the site of ETN PROtect implantation were classified according to Center for Disease Control (CDC) definition into:~superficial incisional surgical site infection (SSI), affecting skin and subcutaneous tissue~deep incisional SSI, affecting deep soft tissue~organ/ space SSI (Osteomyelitis), affecting joint or bursa"|0 - 18 months|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||number of events|||Number
1398072|NCT01282294|Primary|Functional Outcome: WOMAC|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire was administered at 3, 6, 12 and 18 months post-operatively to assess three dimensions: pain, disability and joint stiffness in the knee.~Each question is scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed up, with a possible score range of 0-96. A higher score on the WOMAC indicate more functional limitations."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398073|NCT01282294|Primary|Functional Outcome: IOWA Ankle Score|The Iowa Ankle Score was administered at baseline (retrospective assessment of pre-trauma condition) as well as at 3, 6, 12 and 18 months post-operatively to measures ankle function across four dimensions (function, freedom from pain, gait, range of motion) on a scale of 0-100, where 100 is assigned to full function.|Baseline, 3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398074|NCT01282294|Secondary|Surgeon's Perceived Satisfaction|Surgeons’ perceived satisfaction was assessed on a scale from 0 to 100 (0 = very satisfied, 100 = disappointed).|6 weeks, 3 and 6 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398075|NCT01282294|Secondary|Evidence of Functional Bone Union According to Johnson Classification|"Functional bone union was assessed according to Johnson et al.*:~F0: motion at the fracture site; F1: level of pain is the same as before operation but able to perform all daily tasks of living; F2: occasional extremity pain and able to perform activities of daily living; F3: no pain and able to perform all activities except sports; F4: complete recovery, no recurrent episodes of pain, and unrestricted activity.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."|||participants|||Number
1398076|NCT01282294|Secondary|Evidence of Economic Bone Union According to Johnson Classification|"Economic bone union was assessed according to Johnson et al.*:~E0: complete invalid; E1: no gainful employment; E2: able to work but did not return to previous occupation; E3: returned to previous occupation on a part-time or limited status; E4: returned to previous occupation without restrictions.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."|||participants|||Number
1398137|NCT01281839|Secondary|Median Time to Normalization of Alanine Aminotransferase (ALT) Levels|The table below shows the median time to normalization of ALT levels.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Weeks||95% Confidence Interval|Median
1398077|NCT01282294|Secondary|Evidence of Anatomic Bone Union According to Johnson Classification|"Anatomic bone union was assessed according to Johnson et al.*:~A0: pseudoarthrosis; A1: unilateral pseudoarthrosis; A2: insufficient unilateral bone mass; A3: contiguous union without hypertrophy; A4: solid union of the fracture site.~*Johnson EE, Urist MR, Finerman GA. Repair of segmental defects of the tibia with cancellous bone grafts augmented with human bone morphogenetic protein. A preliminary report. Clin.Orthop.Relat Res. 1988;249-57"|12 months|"Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).~For the anatomic bone union at 12 months, data of 78 patients is available."|||participants|||Number
1398078|NCT01282294|Primary|Quality of Life: EQ-5D|The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398079|NCT01282294|Primary|Quality of Life: SF-12 Mental Component Summary (MCS)|"The SF-12 short form health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.~It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398080|NCT01282294|Primary|Quality of Life: SF-12 Physical Component Summary (PCS)|"The Short Form (SF)-12 health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.~It was administered at 3, 6, 12 and 18 months post-operatively."|3, 6, 12 and 18 months post-operatively|Efficacy is based on the number of patients that were treated with the ETN PROtect according to the protocol. Patients were excluded due to a failure to meet the in-/exclusion criteria (2) and a surgical procedure that was not according to the surgical technique (8).|||scores on a scale||Standard Deviation|Mean
1398081|NCT01282242|Secondary|Number of Subjects With Symptomatic Cerebral Edema|Safety of IV rt-PA as evident by rates of symptomatic cerebral edema defined as brain edema with mass effect as the predominant cause of clinical deterioration.|Within 96 hours of tPA administration||||Participants|||Count of Participants
1398082|NCT01282242|Primary|Number of Subjects With Symptomatic Intracerebral Hemorrhage|Safety of IV rt-PA as evident by rates of symptomatic ICH defined by an increase of 4 points or more on the NIHSS .|Within 7 days from tPA administration.||||Participants|||Count of Participants
1398083|NCT01282229|Secondary|Discomfort|Subjects recorded in a diary discomfort on a 10 point visual analog scale daily for the week following treatment. Subjects provided an estimate for each of the four treated quadrants. Zero (0) represents no pain or discomfort and ten (10) represents severe pain and/or discomfort. For each subject discomfort scores on each day from Day 1 to Day 7 were summed. Medians and ranges for each treatment are recorded. The total score could range from 0 to 70.|1-7 days|Subjects with missing data (e.g., missing diary entries) are not included in the analysis.|||sum of units on a scale|Participants|Full Range|Median
1398084|NCT01282229|Secondary|Change in Gingival Index|The gingival index is a 0-4 unit scale that the examiner uses to estimate the amount of edema and erythema at 2 locations (lingual and buccal) for every tooth in the quadrant. Zero (0) represents no redness and swelling and four (4) represents severe redness and swelling. Negative numbers are a decrease in in examiner estimate of erythema and edema and represent an improvement in clinical outcome.|Baseline, 6, 12 months||||units on a scale from 0-4|Participants|Standard Deviation|Mean
1398085|NCT01282229|Secondary|Change in Bleeding on Probing (BOP)|"Percent of pockets within a quadrant that changed from baseline to 6 or 12 months. Negative numbers are a decrease in bleeding on probing which represents clinical improvement.~Each quadrant within the patient represents one of four treatments, the unit of analysis. Pockets are replications within treatments and vary in number among quadrants."|Baseline, 6, 12 months||||percentage of pockets that bled|Participants|Standard Deviation|Mean
1398086|NCT01282229|Secondary|Change in Probing Depth (PD)|Positive numbers indicate average decrease in probing depth (improvement).|Baseline, 6, 12 months||||mm|Participants|Standard Deviation|Mean
1398087|NCT01282229|Primary|Gain in Clinical Attachment Level of Periodontal Tissues|Periodontitis causes loss of attachment of the tooth root to the surrounding bone. Change in Clinical Attachment Level (CAL) estimates the number of mm's of reattachment gained as a result of the treatment.|Baseline, 6, 12 months|5-6 mm baseline PD partition had a different sample size than the 7+mm partition.|||mm|Participants|Standard Deviation|Mean
1398088|NCT01282203|Secondary|Anesthesiologists' Duration of Clinical Experience With Anesthesia|Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.)|Baseline|Number of anesthesiologists participating in study.|||years||Standard Deviation|Mean
1398118|NCT01282086|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||mm Hg||Standard Deviation|Mean
1398089|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists’ length of clinical experience with general anesthesia and modern inhalation agents was collected (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command|All participants with available data at each time point were included in the analysis.|||Spearman's correlation coefficient|||Number
1398090|NCT01282203|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected (see Outcome Measure 15). The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 ( 1 hour after the surgery), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the surgery|All participants with available data at each time point were included in the analysis.|||Spearman's correlation coefficient|||Number
1398091|NCT01282203|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the creatine kinase myocardial isoenzyme outcome measure.||||||
1398092|NCT01282203|Secondary|Cardiac Troponin (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.||||||
1398093|NCT01282203|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: Blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia|All participants with valid data were included in the analysis.|||Participants|||Number
1398094|NCT01282203|Secondary|Heart Rate|The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||beats per minute||Standard Deviation|Mean
1398095|NCT01282203|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||mm Hg||Standard Deviation|Mean
1398096|NCT01282203|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||mm Hg||Standard Deviation|Mean
1398097|NCT01282203|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the surgery concluded.|Before starting anesthesia to one hour after the surgery|All participants with available data were included in the analysis.|||mm Hg||Standard Deviation|Mean
1398098|NCT01282203|Primary|Patients' Overall Impression of Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: Excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.|||Participants|||Number
1398099|NCT01282203|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The overall satisfaction of the anesthesiologist with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1398100|NCT01282203|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.|||Minutes||Standard Deviation|Mean
1398101|NCT01282203|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command.|All participants with available data were included in the analysis.|||Minutes||Standard Deviation|Mean
1398102|NCT01282203|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 10 minutes|All participants with available data were included in the analysis.|||Minutes||Standard Deviation|Mean
1398103|NCT01282164|Primary|Peak Cortisol Level During Adrenocorticotropin Hormone (ACTH) Stimulation Test|The peak cortisol level during ACTH stimulation test in 3 patients with adult onset hypothalamic-pituitary disease who were older than 65 years of age and could not under go insulin tolerance test (ITT).|one year|Peak cortisol level during ACTH stimulation test in three patients with hypothalamic-pituitary disorders who were older than 65 and could not undergo ITT based on the study protocol|||ug/dL||Full Range|Median
1398116|NCT01282086|Secondary|Presence of Deviations in Electrocardiogram Assessments During Anesthesia|Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).|During induction and maintenance of anesthesia on Day 1|All participants with valid data were included in the analysis.|||participants|||Number
1398104|NCT01282164|Primary|Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).|The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak cortisol level during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders with three or more pituitary hormone deficiency other than GH deficiency. Two patients older than 65 years of age underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.|||ug/dL||Full Range|Median
1398105|NCT01282164|Primary|Peak Cortisol Level in Healthy Volunteers.|The peak cortisol levels during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers.|one year|Peak cortisol levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in healthy volunteers|||ug/dL||Full Range|Median
1398106|NCT01282164|Primary|Peak Cortisol Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).|The peak cortisol level during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak cortisol levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency other than GH deficiency. One patient older than 65 years of age underwent ACTH stimulation test instead of ITT|||ug/dL||Full Range|Median
1398107|NCT01282164|Primary|Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and Three or More Pituitary Hormone Deficiency (PHD).|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease with three or more pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak GH levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders with three or more pituitary hormone deficiency other than GH deficiency. Two patients older than 65 years underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.|||ng/mL||Full Range|Median
1398108|NCT01282164|Primary|Peak Growth Hormone (GH) Level in Healthy Volunteers|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in healthy volunteers|one year||||ng/mL||Full Range|Median
1398109|NCT01282164|Primary|Peak GH Level in Adult Patients With Hypothalamic-pituitary Disorders and 1-2 Pituitary Hormone Deficiency (PHD).|The peak growth hormone (GH) during Insulin Tolerance Test (ITT), fixed- dose glucagon stimulation test (GST) and weight-based GST in patients with adult onset hypothalamic-pituitary disease and 1-2 pituitary hormone deficiency (PHD) other than growth hormone (GH) deficiency.|one year|Peak GH levels during Insulin Tolerance test, fixed-dose GST and weight-based GST in Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency other than GH deficiency. One patient older than 65 years underwent adrenocorticotropin hormone (ACTH) stimulation test instead of ITT.|||ng/mL||Full Range|Median
1398110|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours|As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants|||Units on a scale|Participants|Standard Error|Mean
1398111|NCT01282138|Primary|Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours|As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.|Baseline, 3 hours|All enrolled participants|||Units on a scale|Participants|Standard Error|Mean
1398112|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening|Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected. The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience (exp) with inhalation (inh) anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.|Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.|All participants with available data at each time point were included in the analysis.|||Spearman's correlation coefficient|||Number
1398113|NCT01282086|Secondary|Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia|The anesthesiologists' length of clinical experience with Sevorane was collected. The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 (1 hour after the operation), and the minimum and maximum values, respectively.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||Spearman's correlation coefficient|||Number
1398114|NCT01282086|Secondary|Creatine Kinase Myocardial Isoenzyme (if Available)|Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.|Within 24 hours after anesthesia|All participants with available data were included in the analysis.|||U/L||Standard Deviation|Mean
1398115|NCT01282086|Secondary|Cardiac Troponin (Troponin T) (if Available)|Troponin T values measured within 24 hours of anesthesia were to be collected when available. No data were reported for this outcome measure during the study.|Within 24 hours after anesthesia|No data were available for the cardiac troponin outcome measure.||||||
1398557|NCT01276756|Secondary|Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)|The occurence of adverse events that could be linked temporally and reasonably to the administration of the tested drug.|throughout the period of treatment and up to 90 days after end of triple therapy||||participants|||Number
1398119|NCT01282086|Secondary|Diastolic Blood Pressure|The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n=the number of participants with available data at given time point.|||mm Hg||Standard Deviation|Mean
1398120|NCT01282086|Secondary|Systolic Blood Pressure|The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.|Before starting anesthesia to one hour after the operation|All participants with available data were included in the analysis. n= the number of participants with available data at given time point.|||mm Hg||Standard Deviation|Mean
1398121|NCT01282086|Primary|Patients' Overall Impression of the Anesthesia With Sevorane|After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: excellent, positive, indifferent, or other.|Day 1|All participants with available data were included in the analysis.|||participants|||Number
1398122|NCT01282086|Primary|Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia|The anesthesiologist's overall satisfaction with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).|Day 1|All participants with available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1398123|NCT01282086|Primary|Time to Extubation of Patients|Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.|Every minute after anesthesia was stopped until extubation occurred|All participants with available data were included in the analysis.|||minutes||Standard Deviation|Mean
1398124|NCT01282086|Primary|Time to Awakening of Patients|Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.|Every minute after anesthesia was stopped until the patient responded to a verbal command|All participants with available data were included in the analysis.|||minutes||Standard Deviation|Mean
1398125|NCT01282086|Primary|Time to Loss of Consciousness of Patients Administered Anesthesia|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.|Up to 16 minutes|All participants with available data were included in the analysis.|||minutes||Standard Deviation|Mean
1398126|NCT01281917|Secondary|Overall Survival|Length of time from enrollment until death.|Up to 60 months||||Months||95% Confidence Interval|Median
1398127|NCT01281917|Secondary|Duration of Response|Duration of Response is how long a response to therapy is held before a subject has progressive disease.|Up to 60 months||||months||95% Confidence Interval|Median
1398128|NCT01281917|Secondary|Tolerability of the Regimen|Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.|Up to 36 months||||Participants|||Count of Participants
1398129|NCT01281917|Secondary|Complete Response Rate|The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.|Up to 60 months||||Participants|||Count of Participants
1398130|NCT01281917|Secondary|Safety of This Regimen|Safety of the regimen will be measured by frequency and severity of adverse events.|Up to 36 months||||Participants|||Count of Participants
1398131|NCT01281917|Primary|Progression Free Survival|The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).|Up to 60 months||||Months||95% Confidence Interval|Median
1398132|NCT01281917|Primary|Overall Response Rate|The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 60 months||||Percentage of participants||95% Confidence Interval|Median
1398133|NCT01281865|Primary|Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)||At 8 weeks||||participants|||Number
1398134|NCT01281839|Secondary|Plasma Concentration of TMC435: Systemic Clearance (CL)|The table below shows mean (standard deviation) of CL values of TMC435. To calculate the mean CL for the study, CL values were derived for each participant at each visit and then the median of CL values across visits for each participant was used to calculate the mean CL for the study.|From the time of administration through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||L/h||Standard Deviation|Mean
1398135|NCT01281839|Secondary|Plasma Concentration of TMC435: Predose Plasma Concentration (C0h)|The table below shows mean (standard deviation) of C0h values of TMC435. To calculate the mean C0h for the study, C0h values were derived for each participant at each visit and then the median of C0h values across visits for each participant was used to calculate the mean C0h for the study.|Before administration of TMC435 through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng/mL||Standard Deviation|Mean
1398136|NCT01281839|Secondary|Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean (standard deviation) values of the area under the plasma concentration-time curve from time of administration to 24 hours (AUC 24hr) after dosing for TMC435. To calculate the mean AUC 24 for the study, AUC 24 hr values were derived for each participant at each visit and then the median of AUC value across visits for each participant was used to calculate the mean AUC 24 hr for the study.|From the time of administration up to 24 hours after dosing through Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||ng*h/mL||Standard Deviation|Mean
1402963|NCT01238640|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax, which is the maximum observed plasma concentration after a dose is administered, measured in nanograms/milliliter (ng/mL)|During 10 hours post-dose||||ng/mL||Standard Deviation|Mean
1398138|NCT01281839|Secondary|The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT)|The percentage of participants analyzed were those with baseline ALT values out of the normal range (ie, 156 of 260 participants in the TMC435 treatment group and 84 of 133 participants in the Placebo group had ALT values at baseline that were out of the normal range.). Normalization of ALT values means that ALT values out of the normal range returned to within the normal range.|Up to Week 48|Participants with baseline ALT values out of normal range were used for this analysis from intent-to treat population (defined as all participants who were randomized and received at least one dose of study medication).|||Percentage of Participants|||Number
1398139|NCT01281839|Secondary|Time From End-of-treatment to Viral Relapse|The table below shows the mean number of days to viral relapse, defined as participants having confirmed detectable plasma level of Hepatitis C Virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (<25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||Standard Error|Mean
1398140|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough at Different Time Points|The table below shows the percentage of participants at different time points with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma HCV ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398141|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL|The table below shows mean time in days to reach HCV RNA levels <1000 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1398142|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL|The table below shows mean time in days to reach HCV RNA levels <100 IU/mL.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1398143|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1398144|NCT01281839|Secondary|Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable|The table below shows mean time in days to reach HCV RNA levels <25 IU/mL undetectable or detectable.|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Days||95% Confidence Interval|Median
1398145|NCT01281839|Secondary|The Percentage of Participants With On-treatment Failure|The table below shows percentage of participants with on-treatment failure defined as confirmed detectable Hepatitis C virus ribonucleic acid levels at actual end of treatment.|Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398146|NCT01281839|Secondary|The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule|The table below shows the percentage of participants in the TMC435 treatment group who met the treatment duration rule (ie, having hepatitis C virus [HCV] ribonucleic acid [RNA] levels <25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA levels at Week 12) and completed treatment with PegIFNα-2a and RBV for 24 weeks. Participants in the TMC435 treatment group not meeting RGT criteria and participants in the placebo group were treated with PegIFNα-2a and RBV treatment for 48 weeks.|Week 24|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398147|NCT01281839|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants with viral relapse, defined as having confirmed detectable plasma level of Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398148|NCT01281839|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been below the limit of quantification (25 IU/mL detectable) or undetectable (<25 IU/mL undetectable).|Up to Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398149|NCT01281839|Secondary|The Percentage of Participants With Partial Response|The table below shows the percentage of participants with partial response, defined as =>2 log10 reduction in Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 compared to baseline, but not achieving undetectable HCV RNA while on treatment.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398150|NCT01281839|Secondary|The Percentage of Participants With Null Response|The table below shows the percentage of participants with null response, defined as <2 log10 reduction in Hepatitis C virus ribonucleic acid at Week 12 compared to baseline.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398151|NCT01281839|Secondary|Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4|The table below shows the percentage of participants in each treatment group with HCV RNA levels >1000 IU/mL at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398152|NCT01281839|Secondary|The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4|The table below shows the percentage of participants in each treatment group with <1 log10 HCV RNA decrease at Week 4.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398153|NCT01281839|Secondary|The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants in each treatment group who had a eRVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 4 and 12.|Week 4 and Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398154|NCT01281839|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398155|NCT01281839|Secondary|The Percentage of Participants Achieving a Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of greater than or equal to 2 log10 at Week 12.|Week 12|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398156|NCT01281839|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398157|NCT01281839|Secondary|The Percentage of Participants With On-treatment Virologic Response at All Time Points|The table below shows the percentage of participants with HCV ribonucleic acid (RNA plasma levels below the limit of detection (ie, <25 IU/mL undetectable), the percentage of participants with a HCV RNA plasma level below the limit of quantification (ie, less than [<] 25 IU/mL detectable or undetectable), the percentage of participants with plasma levels of HCV RNA <100 IU/mL, the percentage of participants with virologic responses of a greater than or equal to 2 log10 change from baseline in plasma levels of HCV RNA.|Day 3, Week 1, Week 2, Week 8, Week 16, Week 20, Week 28, Week 36, and Week 42|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398158|NCT01281839|Secondary|Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows actual values of log10 HCV RNA levels. From Week 4 onwards, most participants in TMC 435 150mg 12Wks PR24/48 group had plasma HCV RNA levels below the limit of detection of the HCV RNA assay.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1398159|NCT01281839|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|The table below shows change from baseline in log10 HCV RNA levels.|Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||log10 IU/mL||Standard Error|Mean
1398160|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)|The table below shows the percentage of participants in each treatment group who achieved a SVR4, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 4 weeks after planned end of treatment.|Week 28 or Week 52|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398161|NCT01281839|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels 24 weeks after planned end of treatment.|Week 48 or Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398162|NCT01281839|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of Participants|||Number
1398163|NCT01281839|Primary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.|Week 36 or Week 60|The intent-to-treat population (defined as all participants who were randomized and received at least one dose of study medication) was used for all analyses.|||Percentage of participants|||Number
1398164|NCT01281644|Secondary|Patient Self-rated Severity|This outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the patient at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks||||units on a scale|Participants|Inter-Quartile Range|Median
1398165|NCT01281644|Primary|Difference in Disease Severity Scores|The primary outcome measure was the difference in disease severity total score, combining redness and roughness/bumpiness scales, between the treated site and the control site, as rated by the blinded dermatologists at 12 weeks post-initial visit. These scales were not validated, as no relevant validated scale was available. However, raters were trained and calibrated on the use of the scale, and prior to review of study images, were asked to rate archival skin images on the same 4-point qualitative subscales used in the study. Each scale ranged from 0 to 3, with 0 being none and 3 being severe. The total score summed the redness and roughness/bumpiness scale scores for a range of 0 (none/better outcome) to 6 (severe/worse outcome).|12 weeks||||units on a scale|Participants|Inter-Quartile Range|Median
1398166|NCT01281501|Secondary|Number of Participants That Have Overall Satisfaction on the Treatment|The satisfaction will be assessed by a simple, self-reported yes/no question.|1 hour after treatment||||participants|||Number
1398167|NCT01281501|Secondary|Number of Participants With Adverse Effect|The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.|1 hour after treatment|||||||
1398168|NCT01281501|Secondary|"Number of Participants in the Predefined Non-responders"|“Non-responders” defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study.|pretreatment and 1 hour after treatment||||participants|||Number
1398169|NCT01281501|Secondary|"Number of Participants in the Predefined Responders"|"Responders define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study."|pretreatment and 1 hour after treatment||||participants|||Number
1398170|NCT01281501|Primary|Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment|Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as “Non-responders”(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as “Responders” (good outcome).|1 hour after treatment|All enrolled patients were analyzed with the intention-to-treat principles.|||millimeter||Standard Deviation|Mean
1398171|NCT01281475|Secondary|Presence of Tremors||1 year||||Participants|||Count of Participants
1398172|NCT01281475|Primary|Bayley Cognitive Age Equivalent at 1 Year||12 months||||months||Standard Deviation|Mean
1398173|NCT01281306|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set: The safety analysis set included all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
1398174|NCT01281306|Secondary|Number of Participants Who Achieved Blood Pressure Control and Blood Pressure Response|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). Blood pressure control was defined as msSBP/MSDBP < 140/90 mmHg. Blood pressure response in msSBP was defined as <140 mmHg or a reduction >= 20mmHg from baseline. Blood pressure response in msDBP was defined as < 90 mmHg or a reduction >= 10 mmHg from baseline.|8 weeks|Only participants of the full analysuis set (FAS), who had week 8 measurements, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||Number of participants|||Number
1398175|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants >= 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were >= 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398176|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Participants < 65 Years of Age|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who were leass than 65 years of age and had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398177|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants >= 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were >= 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
1398178|NCT01281306|Secondary|Change From Baseline in msSBP and msDBP in Participants < 65 Years of Age|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who were < 65 years of age and had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
1398217|NCT01280955|Secondary|CD4 Cell Count at Day 60|CD4 cell count at Day 60; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|60 days|The population includes subjects for which we have data at day 30.|||number of CD4 cells||Full Range|Median
1398179|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Non-dippers|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398180|NCT01281306|Secondary|Change From Baseline in maSBP and maDBP in Dippers|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398181|NCT01281306|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398182|NCT01281306|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate measurements were performed. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
1398183|NCT01281306|Secondary|Change From Baseline in Nighttime maSBP and maDBP|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline and 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398184|NCT01281306|Secondary|Change From Baseline in Daytime maSBP and maDBP|Twenty four hour ABPM was performed twice during the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398185|NCT01281306|Secondary|Change From Baseline in Mean 24 Hour Ambulatory SBP (maSBP) and Mean 24 Hour Ambulatory DBP (maDBP)|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. A negative change from baseline indicates improvement.|Baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
1398186|NCT01281306|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
1398187|NCT01281306|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (23-26 hours post-morning dose). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Only participants of the full analysuis set (FAS), who had measurements at both baseline and week 8, were included in the analysis. The FAS included all randomized participants who received at least one dose of double-blind study medication.|||mmHg||Standard Error|Least Squares Mean
1398188|NCT01281202|Secondary|Number of Participants With Cocaine Use||Week 3 - 9||||participants|||Number
1398189|NCT01281202|Primary|Abstinence|The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).|Weeks 8-9||||participants|||Number
1398190|NCT01281124|Secondary|Progression-free Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.||||||
1398191|NCT01281124|Secondary|Overall Survival|Analyzed using a Kaplan-Meier methods.|From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.||||||
1398192|NCT01281124|Primary|DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29|The change in mean methylation of the genes between the patients with a low mir29 and a high mir29 expression will be evaluated by a two-sample t-test. Secondary analyses include a multivariate regression where all 5 changes in methylation will be regressed on mir29 expression (low vs. high) and adjusted for patient demographic and clinical attributes at baseline.|Up to 12 weeks after completion of study treatment|Data analysis was not done due to low accrual for this trial.||||||
1398193|NCT01281007|Secondary|Safety Will be Evaluated by the Adverse Events Occurence|Adverse events will be collected and followed in order to evaluate safety and tolerability|Day 5|||||||
1398194|NCT01281007|Primary|Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation|Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.|Day 5||||subjects|||Number
1398195|NCT01280981|Secondary|Mean Fridericia-corrected QT Interval (QTcFRI) at Month 9|The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization|Month 9|Intent to treat participants who had an electrocardiogram (ECG) at month 9|||milliseconds||Standard Deviation|Mean
1398196|NCT01280981|Secondary|Mean Intraocular Pressure at Month 9|Mean intraocular pressure at month 9 or the early termination visit.|Day 1 up to Month 9|Intent to treat participants who had ophthalmic exams.|||mmHg||Standard Deviation|Mean
1398197|NCT01280981|Secondary|Participants With Treatment Emergent Adverse Experiences (TEAE) of Laboratory Values Related to Treatment|Participants whose laboratory examinations (hematology, blood chemistry and urinalysis) were considered by the investigator to be treatment emergent adverse experiences (TEAE) and related to treatment. Also indicated is whether the TEAE lab parameter caused the participant to discontinue from the study.|Day 1 to up to Month 9|Intent to treat population|||participants|||Number
1398198|NCT01280981|Secondary|Mean Blood Pressure Measurements at Week 36|Mean systolic and diastolic blood pressure measurements taken at week 36|approximately week 36|Intent to treat population of participants with week 36 blood pressure data.|||mmHg||Standard Deviation|Mean
1398199|NCT01280981|Secondary|Participants With Abnormal Gynecological Examinations|Participants with abnormal gynecological examination findings based on endometrial biopsies and transvaginal ultraonogrphy (TVU) are summarized. Clinically significant results from the endometrial biopsies are results that are not benign. Abnormalities found during transvaginal ultrasonography (TVU) are detailed in the AE listings. Please refer to AE listings.|Day 1 to up to Month 9|Intent to treat population|||participants|||Number
1398200|NCT01280981|Primary|Participants With Treatment-Emergent Adverse Events (AEs)|Count of participants with treatment-emergent adverse events grouped in categories regarding relationship to study drug as assessed by the investigator, serious or life-threatening as assessed by the investigator, participants who died or their event led to withdrawal from study, and participants who experienced thrombotic or thromboembolic AEs.|Day 1 to up to Month 9|Intent to treat population (ITT)|||participants|||Number
1398201|NCT01280968|Primary|Vaccination-Induced Percent Change in Initial Slope of Brain Nicotine Accumulation After a Single Puff||measured at week 1 and week 16||||percentage of change||Standard Error|Mean
1398202|NCT01280968|Primary|Vaccination-Induced Percent Change in T1/2 of Brain Nicotine Accumulation After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16||||percentage of change||Standard Error|Mean
1398203|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Maximum Concentration After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16||||percentage of change||Standard Error|Mean
1398204|NCT01280968|Primary|Vaccine-Induced Percent Change in Brain Nicotine Area Under Curve (AUC) After Single or Multiple (7) Puffs|"There was a 2 hour washout period between the single puff and multiple puffs assessments."|measured at week 1 and week 16||||percentage of change||Standard Error|Mean
1398205|NCT01280955|Secondary|TNF-alpha at Day 14|TNF-alpha at day 14; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|14 days|the population includes subject for which we have data at Day 14.|||pg/mL||Full Range|Median
1398206|NCT01280955|Secondary|TNF-alpha at Day 7|TNF-alpha at day 7; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|7 days|the population includes subject for which we have data at Day 7.|||pg/mL||Full Range|Median
1398207|NCT01280955|Secondary|IFN Gamma at Day 14|IFN gamma at day 14; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|14 days|the population includes subject for which we have data at Day 14.|||pg/mL||Full Range|Median
1398208|NCT01280955|Secondary|IFN Gamma at Day 7|IFN gamma at day 7; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|7 days|the population includes subject for which we have data at Day 7.|||pg/mL||Full Range|Median
1398209|NCT01280955|Secondary|IL-12 at Day 14|IL-12 at day 14; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|14 days|the population includes all participants for which we have data at day 14|||pg/mL||Full Range|Median
1398210|NCT01280955|Secondary|IL-12 at Day 7|IL-12 at day 7; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|7 days|the population includes all participants for which we have data at day 7|||pg/mL||Full Range|Median
1398211|NCT01280955|Secondary|B Cell Count at Day 60|B cell count at Day 60; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|60 days|the population includes subjects for which we have data at Day 60.|||number of B cells||Full Range|Median
1398212|NCT01280955|Secondary|B Cell Count at Day 30|B cell count at Day 30; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|30 days|the population includes subjects for which we have data at Day 30.|||number of B cells||Full Range|Median
1398213|NCT01280955|Secondary|NK Cell Count at Day 60|NK cell count at Day 60;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|60 days|the population includes subjects for which we have data at Day 60.|||number of NK cells||Full Range|Median
1398214|NCT01280955|Secondary|NK Cell Count at Day 30|NK cell count at Day 30;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|30 days|the population includes subjects for which we have data at Day 30.|||number of NK cells||Full Range|Median
1398215|NCT01280955|Secondary|CD8 Cell Count at Day 60|CD8 cell count at Day 60; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|60 days|the population includes subjects for which we have data at day 60|||number of CD8 cells||Full Range|Median
1398216|NCT01280955|Secondary|CD8 Cell Count at Day 30|CD8 cell count at Day 30; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|30 days|the population includes subjects for which we have data at day 30|||number of CD8 cells||Full Range|Median
1398239|NCT01280903|Secondary|Fatigue at 52 Weeks|Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398218|NCT01280955|Secondary|CD4 Cell Count at Day 30|CD4 cell count at Day 30; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|30 days|The population includes subjects for which we have data at day 30.|||number of CD4 cells||Full Range|Median
1398219|NCT01280955|Secondary|TNF-alpha at Day 30|TNF-alpha at day 30; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells.|30 days|the population includes subject for which we have data at Day 30.|||pg/mL||Full Range|Median
1398220|NCT01280955|Secondary|IFN Gamma at Day 30|IFN gamma at day 30; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection.|30 days|the population includes subject for which we have data at Day 30.|||pg/mL||Full Range|Median
1398221|NCT01280955|Secondary|B Cell Count at Day 90|B cell count at Day 90; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system.|90 days|the population includes subjects for which we have data at Day 90.|||number of B cells||Full Range|Median
1398222|NCT01280955|Secondary|NK Cell Count at Day 90|NK cell count at Day 90;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system.|90 days|the population includes subjects for which we have data at Day 90.|||number of NK cells||Full Range|Median
1398223|NCT01280955|Secondary|CD8 Cell Count at Day 90|CD8 cell count at Day 90; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR).|90 days|the population includes subjects for which we have data at day 90|||number of CD8 cells||Full Range|Median
1398224|NCT01280955|Secondary|CD4 Cell Count at Day 90|CD4 cell count at Day 90; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells.|90 days|The population includes subjects for which we have data at day 90.|||number of CD4 cells||Full Range|Median
1398225|NCT01280955|Secondary|CD3+ Cell Count at Day 90|Cell reconstitution - CD3+ cell count at day 90 post transplant. This is a marker for the function of your immune system.|90 Days|the population includes all participants for which we have data at day 90|||number of CD3+ cells||Full Range|Median
1398226|NCT01280955|Secondary|Participants Experiencing Grade II-IV Acute Graft Versus Host Disease|We are reporting on the number of participants experiencing a grade II-IV acute graft versus host disease will be assessed weekly through Day 100 post transplant. Staging and grading of Acute GvHD is graded by pattern of organ involvement and clinical performance status using the Grading Index of Acute GvHD (Gluckman) and the Grading Index of Acute GVHD by the CIBMTR (Centers for International Blood and Marrow Transplant Research)|100 days||||participants|||Number
1398227|NCT01280955|Secondary|IL-12 at Day 30|IL-12 at day 30; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation.|30 days|the population includes all participants for which we have data at day 30|||pg/mL||Full Range|Median
1398228|NCT01280955|Secondary|Absolute Lymphocyte Count at Day 90|Cell reconstitution - absolute lymphocyte count at day 90 post transplant.|90 days|the population includes all participants for which we have data at day 90|||number of lymphocytes||Full Range|Median
1398229|NCT01280955|Secondary|Transplant-related Mortality||100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||participants|||Number
1398230|NCT01280955|Primary|Plerixafor-associated Adverse Events||100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||number of adverse events|||Number
1398231|NCT01280955|Primary|Time to Platelet Recovery|platelet > 20,000/ul on 2 consecutive days|100 Days Post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||days||95% Confidence Interval|Median
1398232|NCT01280955|Primary|Time to Neutrophil Recovery|leukocytes > 500/ul on 2 consecutive days|100 Days post Transplant|Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed|||days||95% Confidence Interval|Median
1398233|NCT01280942|Secondary|Clinical Outcomes and Process Measures|length of stay|Hospital discharge||||days||Inter-Quartile Range|Median
1398234|NCT01280942|Primary|Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm|The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.|Within 24 hrs of an EWS alert||||participants|||Number
1398235|NCT01280903|Secondary|Outcome Expectancy at 52 Weeks|"Measured by the Perceived Therapeutic Efficacy Scale in terms of the following:~Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398236|NCT01280903|Secondary|Arthritis Self-Efficacy at 52 Weeks|"Measured by the Arthritis Self-Efficacy Scale in terms of the following:~Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398237|NCT01280903|Secondary|Self-Efficacy at 52 Weeks|"Measured by the Self-Efficacy Scale in terms of the following:~Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398238|NCT01280903|Secondary|Health-Related Quality of Life at 52 Weeks|"Measured by the Short Form-36v2 in terms of the following:~Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better"|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398241|NCT01280903|Secondary|Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 52 Weeks|Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398242|NCT01280903|Secondary|Quadriceps Strength at 52 Weeks|Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.|6 months after the intervention period ends (week 52)||||pounds||Standard Error|Mean
1398243|NCT01280903|Secondary|Subjective Functional Status at 52 Weeks|Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398244|NCT01280903|Secondary|Outcome Expectancy at 25 Weeks|"Measured by the Perceived Therapeutic Efficacy Scale in terms of the following:~Exercise and Arthritis: the scale score range is 0-100; higher scores are better Exercise and Hypertension: the scale score range is 0-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398245|NCT01280903|Secondary|Arthritis Self-Efficacy at 25 Weeks|"Measured by the Arthritis Self-Efficacy Scale in terms of the following:~Pain subscale: the subscale score range is 10-100; higher scores are better Function subscale: the subscale score range is 10-100; higher scores are better Other Symptoms subscale: the subscale score range is 10-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398246|NCT01280903|Secondary|Self-Efficacy at 25 Weeks|"Measured by the Self-Efficacy Scale in terms of the following:~Exercise Barriers Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better Exercise Self-Efficacy subscale: the subscale score range is 0-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398247|NCT01280903|Secondary|Health-Related Quality of Life at 25 Weeks|"Measured by the Short Form-36v2 in terms of the following:~Mental Component: this summary scale is composed of eight subscale scores primarily derived from the mental health, role functioning-emotional, and social functioning scores; the scale score range is 0-100; higher scores are better Physical Component: this summary scale is composed of eight subscale scores primarily derived from the physical functioning, role functioning-physical, and bodily pain scores; the scale score range is 0-100; higher scores are better"|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398248|NCT01280903|Secondary|Fatigue at 25 Weeks|Measured by the Brief Fatigue Inventory, which assesses fatigue severity; the scale score range is 0-10; lower scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398249|NCT01280903|Secondary|Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks|Measured by the Bodily Pain subscale of the Short Form-36v2; the subscale score range is 0-100; higher scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398250|NCT01280903|Secondary|Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks|Measured by the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-20; lower scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398251|NCT01280903|Secondary|Quadriceps Strength at 25 Weeks|Measured by the MicroFET2 hand-held dynamometer in terms of mean maximum pounds over two trials.|At the end of the 6-month intervention period (week 25)||||pounds||Standard Error|Mean
1398252|NCT01280903|Secondary|Subjective Functional Status at 25 Weeks|Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; the subscale score range is 0-68; lower scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398253|NCT01280903|Primary|Diastolic Blood Pressure at 52 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|6 months after the intervention period ends (week 52)||||mm Hg||Standard Error|Mean
1398254|NCT01280903|Primary|Systolic Blood Pressure at 52 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|6 months after the intervention period ends (week 52)||||mm Hg||Standard Error|Mean
1398255|NCT01280903|Primary|Objective Functional Status by the Short Physical Performance Battery at 52 Weeks|Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.|6 months after the intervention period ends (week 52)||||units on a scale||Standard Error|Mean
1398256|NCT01280903|Primary|Objective Functional Status by the 6-minute Walk at 52 Weeks|Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.|6 months after the intervention period ends (week 52)||||yards||Standard Error|Mean
1398257|NCT01280903|Primary|Participation in Fitness Walking at 52 Weeks|Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.|6 months after the intervention period ends (week 52)||||minutes||Standard Error|Mean
1398258|NCT01280903|Primary|Performance of Lower Extremity Exercise at 52 Weeks|Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the subject reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period).|6 months after the intervention period ends (week 52)||||repetitions x sets/week||Standard Error|Mean
1398259|NCT01280903|Primary|Diastolic Blood Pressure at 25 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|At the end of the 6-month intervention period (week 25)||||mm Hg||Standard Error|Mean
1398260|NCT01280903|Primary|Systolic Blood Pressure at 25 Weeks|Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.|At the end of the 6-month intervention period (week 25)||||mm Hg||Standard Error|Mean
1402964|NCT01238588|Secondary|Hemodialysis Access Stenosis/Thrombosis||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).||||||
1398261|NCT01280903|Primary|Objective Functional Status by the Short Physical Performance Battery at 25 Weeks|Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.|At the end of the 6-month intervention period (week 25)||||units on a scale||Standard Error|Mean
1398262|NCT01280903|Primary|Objective Functional Status by the 6-minute Walk at 25 Weeks|Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.|At the end of the 6-month intervention period (week 25)||||yards||Standard Error|Mean
1398263|NCT01280903|Primary|Participation in Fitness Walking at 25 Weeks|Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.|At the end of the 6-month intervention period (week 25)||||minutes||Standard Error|Mean
1398264|NCT01280903|Primary|Performance of Lower Extremity Exercise at 25 Weeks|Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the participant reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [repetitions x sets] over a 7-day period).|At the end of the 6-month intervention period (week 25)||||repetitions x sets/week||Standard Error|Mean
1398265|NCT01280695|Secondary|Change From Baseline in High Molecular Weight Adiponectin|To evaluate the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on biomarkers of inflammatory status (high molecular weight adiponectin) following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||ng/mL||Standard Error|Least Squares Mean
1398266|NCT01280695|Secondary|Change in Fasting Plasma Insulin|To characterize the effects of 3 different doses of MSDC-0602 and pioglitazone as compared to placebo on insulin following once-daily dosing for 28 consecutive days|Baseline and 28 days|The Per-Protocol population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||µIU/mL||Standard Deviation|Least Squares Mean
1398267|NCT01280695|Secondary|Change From Baseline in Hematocrit|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo in hematocrit following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||Change from baseline||Standard Error|Least Squares Mean
1398268|NCT01280695|Secondary|Change From Baseline in Body Weight|To characterize the effects of three different doses of MSDC-0602 and pioglitazone as compared to placebo on hematocrit, body weight, and edema following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||kg||Standard Error|Least Squares Mean
1398269|NCT01280695|Secondary|Change From Baseline in HbA1c|To explore the drug effect difference in the reduction in hemoglobin A1c in response to three different doses of MSDC-0602 and pioglitazone (45 mg Actos®) as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|The Per-Protocol Population included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1398270|NCT01280695|Primary|Change From Baseline in Fasting Plasma Glucose|To characterize the reduction in fasting plasma glucose in response to three different doses of MSDC-0602 Tablets as compared to placebo following once-daily dosing for 28 consecutive days in patients with Type 2 diabetes.|Baseline and 28 days|Per-Protocol Population:Included all patients who completed the 4-week, double blind treatment period without any major deviations from the protocol procedures. The Per-Protocol Population was used for all efficacy measurements.|||mg/dL||Inter-Quartile Range|Median
1398271|NCT01280656|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||participants|||Number
1398272|NCT01280656|Secondary|Percentage of Participants Who Discontinued Treatment Due to Adverse Events|The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
1398273|NCT01280656|Secondary|Percentage of Participants With Null Response or No Responder at End of Treatment|Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
1398274|NCT01280656|Secondary|Percentage of Participants With Virologic Relapse up to Week 72|Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).|||percentage of participants|||Number
1399058|NCT01271803|Primary|Cmax of Vemurafenib on Day 1, Cycle 1 in BRAFi-naïve Participants||Predose (0 hr) on Day 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population.Here, number of participants analyzed = participants who were BRAFi-naïve participants.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1398275|NCT01280656|Secondary|Percentage of Participants With Virologic Response at End of Treatment|Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.|At Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
1398276|NCT01280656|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.|At Week 4|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
1398277|NCT01280656|Secondary|Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders|The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.|Up to Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.|||mean percentage reduction of hemoglobin||Standard Deviation|Mean
1398278|NCT01280656|Secondary|Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment|The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|Up to Week 48|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)|||percentage of participants|||Number
1398279|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home|The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.|At Week 60 (SVR 12) and Week 72 (SVR 24)|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group excluding participants treated at an unknown location (2/16, 5/126, and 9/101 respectively).|||percentage of participants|||Number
1398280|NCT01280656|Secondary|Percentage of Participants With Early Virologic Response at Week 12|An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.|At Week 12|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.|||percentage of participants|||Number
1398281|NCT01280656|Secondary|Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used|The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported|At Week 24|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).|||participants|||Number
1398282|NCT01280656|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment|SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 72|The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).|||percentage of participants|||Number
1398283|NCT01280656|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment|Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants’ plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants’ plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.|At Week 60|The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).|||percentage of participants|||Number
1398284|NCT01280604|Secondary|Serum Creatinine(SCr)|SCr levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
1398285|NCT01280604|Secondary|Aspartate Aminotransferase (AST)|AST levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||international units/liter||Standard Deviation|Mean
1398286|NCT01280604|Secondary|Alanine Aminotransferase(ALT)|ALT levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||international units/liter||Standard Deviation|Mean
1398287|NCT01280604|Secondary|High-density Lipoprotein,(HDL)|HDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
1398288|NCT01280604|Secondary|Low-density Lipoprotein (LDL)|LDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
1398290|NCT01280591|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398291|NCT01280591|Secondary|Cumulative Proportion of Subjects Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population|||participants|||Number
1398292|NCT01280591|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
1398293|NCT01280591|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398294|NCT01280591|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
1398295|NCT01280591|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
1398296|NCT01280591|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
1398297|NCT01280591|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
1398298|NCT01280591|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
1398299|NCT01280591|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398300|NCT01280591|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398301|NCT01280591|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398302|NCT01280591|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398303|NCT01280591|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398304|NCT01280591|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398305|NCT01280591|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398306|NCT01280591|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1398307|NCT01280591|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
1398308|NCT01280591|Secondary|Total Sleep Time Measured by Actigraphy|Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1398309|NCT01280591|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
1398310|NCT01280591|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1398311|NCT01280552|Secondary|Progression Free Survival in HLA- A2 Patients|"Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype.~Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed"|2-3 yers|HLA-A2 patients|||months of progression free survival||95% Confidence Interval|Median
1398312|NCT01280552|Primary|Overall Survival in HLA-A2 Patients|Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.|2-3 years|Patients with HLA-A2 haplotype|||months of survival||95% Confidence Interval|Median
1398313|NCT01280552|Secondary|PFS|"Secondary Endpoints~PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed.~Population is all randomized patients ITT."|2-3 years|Intent to treat includes all randomized patients|||months of progression free survival||95% Confidence Interval|Median
1398314|NCT01280552|Primary|Overall Survival (OS)|The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis|2 -3 years|Intent to treat include all randomized patients|||months of survival||95% Confidence Interval|Median
1398315|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Maternal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, maternal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"|||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
1398316|NCT01280357|Primary|The Mean Positive Percentage Agreement (PPA) for Fetal Heart Between Device 1 Monica AN24 & Device 2 Philips 50XM|During Labor & delivery, fetal heart rate was measured between the Monica AN24 & the Philips 50XM and the waveforms of the 2 devices were measured to see the percentage of time they were in agreement.|during labor and delivery the waveforms were measured for between 35 minutes and 15 hours during the first and second stage of labour|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in a FDA 6 way trial for Fetal Heart Rate (FHR)and Uterine Activity (UA) 2 participants were uesd in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"|||Positive percantage agreement (PPA)||95% Confidence Interval|Mean
1398317|NCT01280357|Secondary|The Mean Positive Percentage Agreement for Uterine Contractions Between the Monica AN24 & The Philips 50XM|During labor and delivery uterine contractions were measured between the Monica AN24 & the philips 50XM, the waveforms of the two devices were measured to see the percentage of time they were in agreement|between 35 mins & 15hrs during first & second stage labor|"Of the remaining 34 participants in the clinical trials.The data was collected in the following manner.~31 participants were used in FDA 6 way trial for Fetal Heart Rate (FHR) and Uterine Activity (UA) 2 participants were used in a 3 way trial for FHR~1 participant was used in a 3 way trial for UA Equates to 33 files for FHR & 32 files for UA"|||Positive Percentage Agreement (PPA)||95% Confidence Interval|Mean
1398318|NCT01280266|Secondary|Dorsal-digital-difference.|The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.|baseline and 4 weeks||||degree celcius.||Standard Deviation|Mean
1398319|NCT01280266|Secondary|Time-averaged Peak Velocity (cm/Sec)|changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.|baseline and 4 weeks||||cm/sec||Standard Deviation|Mean
1398320|NCT01280266|Secondary|Change in Peak Systolic Flow (cm/Sec)|"Change in digital artery flow velocity in proper palmar digital artery in cm/sec.~0-unlimited"|baseline and 4 weeks||||cm/sec||Standard Deviation|Mean
1398321|NCT01280266|Secondary|Change in Digital Ulcer Number|0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.|baseline and 4 weeks||||Digital ulcers||Standard Deviation|Mean
1398322|NCT01280266|Secondary|Change in Physician's Global Assessment on Visual Analogue Scale (VAS)|"Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline.~negative value (decrease in value) means improvement."|at 0 (baseline) and 4 weeks (after treatment)||||units on a scale||Standard Deviation|Mean
1398323|NCT01280266|Secondary|Change in Health Assessment Questionnaire (HAQ)|Ordinal scale 0-10 0 good 10 bad|0 and 4 weeks||||units on a scale||Standard Deviation|Mean
1398324|NCT01280266|Secondary|Change in the RP Duration|Change in the average RP duration in minutes (min) per attack. 0 -- unlimited|baseline and 4 weeks||||min per attack||Standard Deviation|Mean
1398325|NCT01280266|Secondary|Change in Raynaud's Condition Score (RCS)|"change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20).~Range 0-10 ordinal scale 0..good 10.. bad"|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1398326|NCT01280266|Primary|RP Attacks Per Day|Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.|baselin and 4 weeks|14 patients in UA arm + 12 patients in AU arm|||attacks per day||Standard Deviation|Mean
1398327|NCT01280123|Secondary|Change in the 15-item Geriatric Depression Scale (GDS-15)From Baseline to 44 Weeks|The Geriatric Depression Scale - 15 is a short 15 yes or no question instrument for assessing depression in the elderly. It has been found to be particularly useful in assessing depression in Parkinson's Disease. A score of 0 to 5 is normal. A score greater than 5 suggests depression.|44 weeks||||units on a scale||95% Confidence Interval|Mean
1398328|NCT01280123|Secondary|Change in the Mattis Dementia Rating Scale (DRS-2)From Baseline to 44 Weeks|The Mattis dementia rating scale is a psychometric instrument designed to assess the extent and nature of dementia. Mattis Dementia Rating scale (DRS-2) raw score is the sum of 5 raw sub-scores (attention has possible 37 points, initiation/perseveration has possible 37 points, construction has possible 6 points, conceptualization has possible 39 points, memory has possible 25 points). Total range is 0-144. Higher scores are better.|44 weeks||||units on a scale||95% Confidence Interval|Mean
1398329|NCT01280123|Secondary|Change in Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 44 Weeks|"The Parkinson's Disease Questionnaire (PDQ-39) is a short, 39 item measure of quality of life in subjects with Parkinson's disease. The questionnaire covers 8 aspects of quality of life: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort.~The total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life."|44 weeks||||units on a scale||95% Confidence Interval|Mean
1398330|NCT01280123|Secondary|Change in Schwab and England Scale From Baseline to 44 Weeks|The modified Schwab and England Activities of Daily Living is a single question ranging from 0-100% with anchors for each 10% interval. Higher scores are better (100% completely independent- 0% vegetative).|44 weeks||||units on a scale||95% Confidence Interval|Mean
1398331|NCT01280123|Secondary|Change in Ambulatory Capacity From Baseline to 44 Weeks|"This is the sum of the 5 UPDRS questions regarding ambulatory capacity: falling, freezing, walking, gait, postural stability.~Ambulatory Capacity is calculated as the sum of items 13-15, 29, 30 of the Unified Parkinson's Disease Rating Scale (UPDRS). It ranges from 0-20. Higher scores are worse. Change is 44 weeks - baseline."|44 weeks||||units on a scale||95% Confidence Interval|Mean
1398332|NCT01280123|Primary|Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline to 44 Weeks|"Change in total UPDRS score from baseline to 44 weeks (in subjects treated with rasagiline 1 mg/day or selegiline 10 mg/day).~The Total UPDRS is the sum of parts I, II, and III. The possible range of the total UPDRS is from 0-176. Higher values indicate worse outcomes.~The change is 44 weeks - baseline."|44 weeks||||units on a scale||Standard Error|Mean
1398333|NCT01280110|Secondary|Macular Thickness|Macular thickness will be measured with an Optical coherence tomography (OCT). Measures 5% under the normal population according to the OCT software will be considered break in the blood-retina barrier.|Baseline, 15 days and 30 days.|Statiscal power of 80%|||μm||Standard Deviation|Mean
1398334|NCT01280110|Primary|Aqueous Humor Flare|Aqueous humor flare indicates the degree of a break in the blood-aqueous barrier. It is objectively measured with a Laser flare meter.|Baseline, 15 days and 30 days.|Statiscal power of 80%.|||photons/msec||Standard Deviation|Mean
1398335|NCT01280058|Other Pre-specified|Percentage of Patients With Ras Pathway Activation|The 95% confidence interval will be assessed. Cochran-Mantel-Haenszel test will be used to assess differences in the relationships between response and Ras pathway activation and the association of treatment groups on these relationships.|Baseline||||percentage of patients|||Number
1398336|NCT01280058|Other Pre-specified|Immunologic Correlative Markers|The inflammatory cytokine profile, immune effector cell phenotype and function, and NARA titers will be assessed and compared. Patterns of change in the longitudinal data on these markers will be evaluated for each of the correlative outcomes of interest.|Up to day 1 of course 12|data was not collected||||||
1398337|NCT01280058|Secondary|Overall Survival|Evaluated and compared between the two treatment groups using log-rank statistics and graphically using the methods of Kaplan and Meier.|From study entry to the time of death due to any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
1398338|NCT01280058|Secondary|Overall Response Rate (Partial or Complete Response) Evaluated Using the Standard RECIST v. 1.1|95% confidence intervals will be calculated. Differences in objective response rates between the treatment arms will be assessed using Fisher’s exact test.|Up to 4 years||||Participants|||Count of Participants
1398339|NCT01280058|Secondary|Incidence of Severe (Grade 3+) Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment, as Assessed by NCI CTCAE Version 4.0|Toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher’s exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms.|Up to 4 years||||percentage of patients|||Number
1398340|NCT01280058|Primary|Progression-free Survival Using RECIST v. 1.1|The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.|From study entry to the date of documented progression and/or death, assessed up to 4 years||||months||95% Confidence Interval|Median
1398341|NCT01279681|Other Pre-specified|Prognostic Single-nucleotide Polymorphisms (SNPs) for Grade 3+ Hypertension|Logistic regression models and conditional inference trees (or more generally conditional random forests) will be used to construct multi-variable models based on the SNPs identified as interesting.|Up to 42 days after treatment discontinuation|||||||
1402965|NCT01238588|Secondary|Rate of Cardiovascular Events||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).||||||
1398342|NCT01279681|Other Pre-specified|Overall Incidence of Grade >= 3 Toxicity in Elderly Patients|A logistic regression model will be used to determine the odd ratios for the occurrence of grade 3 + toxicity with a 95% confidence interval, and the overall association will be assessed by a likelihood ratio test with a two-sided alpha level of 0.05. As a secondary analysis, a multivariate logistic model will be applied including covariates for treatment arm and the stratification factors: age, PS and metastatic sites.|Up to 42 days after discontinuation of treatment|||||||
1398343|NCT01279681|Other Pre-specified|Proportion of Patients Reporting Satisfaction Using the Was It Worth IT (WIWI) Questionnaire|WIWI will be summarized descriptively to identify the number of patients who were satisfied with each treatment and indications for improvements therein. Proportion of patients' satisfaction will be compared between treatments by a Fisher’s exact test. The impact of the clinical trial on patient QOL will be summarized via means and standard deviations and compared between treatment arms via a Wilcoxon rank sum test.|Baseline to up to 42 days after termination of study treatment|||||||
1398344|NCT01279681|Other Pre-specified|Change in QOL Using the Fatigue/Uniscale Assessment, Linear Analog Self-Assessment (LASA), and the European Quality of Live Five Dimensions Questionnaire (EQ-5D)|A cut-point of 5 or lower on the overall QoL question will be defined to be the primary cut-off for analysis as that has been demonstrated to represent clinically deficient QoL.|Baseline to up to 42 days after termination of study treatment|||||||
1398345|NCT01279681|Other Pre-specified|Change in Geriatric/Frailty Using the North Central Cancer Treatment Group (NCCTG) Brief Frailty Inventory and the Rockwood Frailty Index Physician and Patient-reported Items|The various measures of geriatric/frailty (Canadian Geriatric Society [CGSA], Rockwood, and NCCTG measures) will be compared head to head using Bland-Altman methods to assess the differences between clinician and patient reported frailty and the relative information obtained from the various assessments. This will be the first head to head comparison of its type to assess geriatric/frailty measures.|Baseline to 42 days after termination of study treatment|||||||
1398346|NCT01279681|Secondary|Number of Participants With Grade 3 Adverse Events At Least Possibly Related to Treatment|Adverse events were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 42 days after treatment discontinuation|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||Participants|||Count of Participants
1398347|NCT01279681|Secondary|Response Rate, Defined as the Percentage of Patients in Each Arm Who Have an Objective Status of Complete Response or Partial Response, Confirmed by a Second Assessment Measured at Least 6 Weeks From the Initial Assessment|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;~Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;~Stable Disease (SD): small changes that do not meet above criteria.~Response rate is reported as the percentage of participants who achieved Complete Response or Partial Response."|Up to 5 years|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
1398348|NCT01279681|Secondary|Overall Survival|Overall survival was defined as the time (in months) from randomization to death.|Up to 5 years|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||months||Full Range|Median
1398349|NCT01279681|Primary|Progression-Free Survival|Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the time (in months) from the date of randomization to the date of documented disease progression or death, whichever occurs first. Patients were followed until progression (and progression was declared) regardless of whether the patient was on the first line treatment or not. Patients who progress following a missed scan will have their date of progression back-dated to the date of missing scan. Patients without a progression who are still alive at the time of analysis will be censored at the date of last follow-up.|Up to 5 years|One participant who refused to initiate study treatment following randomization was excluded from the analysis.|||months||Full Range|Median
1398350|NCT01279564|Primary|Duration of Endotracheal Intubation|Time between introducing the laryngoscope and inflation of tube's cuff|The induction of general anesthesia, on the operating day (first day)||||seconds||Standard Deviation|Mean
1398351|NCT01279564|Primary|In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube||1 year|||||||
1398352|NCT01279447|Primary|Post op Pain Score|immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.|0 hours||||units on a scale||Standard Deviation|Mean
1398353|NCT01279317|Primary|Postprandial Glycemic Incremental Area Under the Curve|area under the plasma glucose concentration curve, above the baseline plasma glucose, measured over 2 hr following ingestion of a the intervention beverages|2 hr|all subjects completed study and are included in analysis|||mmol/L / 2hr||Standard Error|Mean
1398354|NCT01279265|Secondary|Fecal Calprotectin|Test intestinal inflammation in the infants. Calprotectin is made by white blood cells called neutrophils. The number of neutrophils in the intestine is reflected by the fecal calprotectin level.|90 days||||µg/g (feces)||95% Confidence Interval|Mean
1398355|NCT01279265|Secondary|Fecal Microbiota|Analyze and identify bacteria in the stool of the subjects. We will use pyrosequencing to characterize the bacteria colonizing the stool. We will measure diversity by Shannon's diversity index in the two groups.|90 days||||Shannon's diversity index value||Standard Deviation|Mean
1398356|NCT01279265|Primary|Daily Average Crying and Fussing Duration According to Barr Diary Records|The parent or guardian will complete a Barr diary to measure crying and fussing times of colicky infants . It is a daily timeline that records the number of minutes in five minute increments with fussiness and crying. The average colicky infant cries and fusses is more than 3 hours daily. If infants surpasses the 3 hours for more than three days (not consecutive) and are less than 3 months of age, they are considered to have colic.|90 days||||minutes||95% Confidence Interval|Mean
1398357|NCT01279200|Primary|Pregnancy Success Rate|Percentage of women in each arm who became pregnant within the study time frame.|3 menstrual/treatment cycles (approximately 28-33 days each)||||percentage of participants|||Number
1398358|NCT01279200|Secondary|Time to Conception, Measured in Cycles|Cycles means treatment/menstrual cycles, approximately 28-33 days.|3 menstrual/treatment cycles, or upon conception, whichever comes first|Numbers of participants analyzed changes from 8 with kits and 4 with ultrasound (enrolled) because time to conception can be measured only for those who conceived, so the 6 and 1 participants analyzed here are those who were successful in getting pregnant.|||menstrual cycles||Full Range|Mean
1398359|NCT01279187|Secondary|Bone Turnover: Bone Percentages|"Oc.S/BS cancellous: Osteoclast suface divided by bone surface. Osteoclastic surface as percent of total bone surface in cancellous bone. Percent cancellous bone perimeter with osteoclasts (large, multinuclear, TRAP positive cells).~OS/BS cancellous: Osteoid surface divided by bone surface. Percentage of cancellous bone perimeter covered with osteoid.~Oc.S/BS endocortical: Osteoclastic surface as percent of total bone surface in endocortical bone.~OS/BS endocortical: Percentage of endocortical bone perimeter covered with osteoid.~Oc.S/BS Periosteal: Osteoclastic surface as percent of total bone surface in periosteal bone.~Ob.S/BS Periosteal: Percent periosteal bone perimeter with osteoid and adjacent osteoblasts, identified as plump cells with a single, eccentric nucleus and a pale-staining golgi apparatus. Osteoblast Surface divided by bone surface in periosteal bone.~OS/BS Periosteal: Percentage of periosteal bone perimeter covered with osteoid."|10 weeks||||percentage (%)||Standard Deviation|Mean
1398360|NCT01279187|Secondary|Bone Turnover: Bone Perimeter Length|"Bone histomorphometry was used to assess bone perimeter length in mm as follows:~Cn.Pm cancellous: Cancellous Bone Perimeter Ec.Pm: endocortical bone perimeter Ps.Pm: Periosteal Periosteal bone perimeter"|10 weeks||||mm||Standard Deviation|Mean
1398361|NCT01279187|Secondary|Bone Turnover: Cortical Tissue Area|"Bone turnover was assessed indirectly by evaluating cellular parameters of PTH action (i.e. numbers of osteoblasts, osteoclasts, apoptotic osteoblasts). The methods used to obtain the outcomes described below were bone histomorphometry using the following abbreviation:~Ct.T.Ar: Ct Cort(ex)(ical) Tissue Area (2D)b~“First set” refers to baseline pre-drug data and “second set” was taken at the end of the drug administration phase."|10 weeks||||mm2/week||Standard Deviation|Mean
1398362|NCT01279187|Secondary|Bone Turnover (Mineral Apposition Rates)|"Bone turnover was assessed indirectly by bone histomorphometry using the following abbreviations: Mineral Apposition Rate (MAR): Distance between 2 fluorochrome markers that comprise a double label on the surfaces of cancellous bone measured at an average of 4 equally-spaced sites per double label. These measurements will be performed on 20 double fluorochrome labels per bone and the average divided by the time between the midpoints of the two labeling periods. MAR serves as an index of osteoblast activity. Reported for cancellous (Cn), endocortical (Ec) at baseline (pre-drug intervention, listed as “first set”) and at the end of drug intervention (“second set”). “First set” refers to baseline information (pre-drug), and “second set” refers to data evaluated at the end of the drug administration phase. Periosteal (Ps) data and Ec.Mar Endocortical MAR second set was reviewed but no analyzable labeling was noted and so this data is not reported."|10 weeks||||um/day||Standard Deviation|Mean
1398363|NCT01279187|Primary|Bone Formation Rate|To determine the impact of PTH on bone quality and bone turnover in the oral cavity. The primary outcome variable will be bone formation rate.|10 weeks||||mm2/week||Standard Deviation|Median
1398364|NCT01279109|Secondary|Social Network|Number of discussion partners within the intervention group. Participants were asked to identify by name any program participants with whom they had spoken about their pregnancy or pregnancy-related health behaviors.|2 times over 12 weeks (Week 6, Week 12)|59 participants in the intervention group completed at least one wave of social network data collection. Control group participants did not have protocol-specified group sessions to evaluate.|||number of discussion partner ties||Standard Deviation|Mean
1398365|NCT01279109|Primary|Gestational Weight Gain|"Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy.~(Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.)"|Duration of pregnancy|Analysis is presented within baseline BMI categories and overall. The Overall Number of Participants Analyzed represents those study participants for whom medical records could be abstracted in the trial (87/135).|||Participants|||Count of Participants
1398366|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30–max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 40 weeks||||units on a scale||Standard Deviation|Mean
1398367|NCT01279070|Secondary|Psychiatric Symptoms|The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30–max. 210) with a score of 30 representing an absence of psychiatric symptoms.|Change from baseline in psychiatric symptoms scales at 16 weeks||||units on a scale||Standard Deviation|Mean
1398368|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39–max. 156) with a higher score indicating a better result.~The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0–max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
1399115|NCT01270971|Secondary|Negative Mycology of Target Great Toenail at Week 52|Negative KOH and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1398369|NCT01279070|Secondary|Psychosocial Functioning|"The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39–max. 156) with a higher score indicating a better result.~The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0–max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation."|Change from baseline in social functioning scales at 16 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
1398370|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.~12–max. 129). A higher score indicates better performance."|Change from baseline in executive functioning at 40 weeks|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
1398371|NCT01279070|Primary|Executive Function|"Behavioral Assessment of the Dysexecutive Syndrome (BADS). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgment, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min.~12–max. 129). A higher score indicates better performance."|Change from baseline in executive function at 16 weeks (post-treatment)|The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.|||units on a scale||Standard Deviation|Mean
1398372|NCT01279044|Secondary|Number of Condom-protected Anal Intercourse Events|"The outcome measure data shows the rate of change in the mean value of the number of condom-protected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.~Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months||||Self reported behavior in past 3 months|||Number
1398373|NCT01279044|Secondary|Number of Receptive UAI Events|"The outcome measure data shows the rate of change in the mean value of the number of receptive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Self reported behavior in past 3 months|||Number
1398374|NCT01279044|Secondary|Number of Instertive UAI Events|"The outcome measure data shows the rate of change in the mean value of number of instertive unprotected anal intercourse (UAI) events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Self reported behavior in past 3 months|||Number
1398375|NCT01279044|Secondary|Number of Serodiscordant Unprotected Anal Intercourse (SDUAI) Events|"The outcome measure data shows the rate of change in the mean value of number of serodiscordant unprotected anal intercourse events. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints.~Serodiscordant defined as having partner of discordant or of unknown HIV serostatus."|Self-reported behavior during past 3 months||||Events in past 3 months|||Number
1398376|NCT01279044|Primary|Unprotected Anal Intercourse Episodes With Three Most Recent Sex Partners at Each Follow-up Visit, Exclusive of Primary HIV-negative Partners.|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse episodes with three most recent sex partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Episodes in past 3 months|||Number
1398377|NCT01279044|Primary|Total Unprotected Anal Intercourse Partners|"The outcome measure data shows the rate of change in the mean value of total unprotected anal intercourse partners over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Partners in past 3 months|||Number
1398378|NCT01279044|Primary|Total Unprotected Anal Intercourse Events (Exclusive of Those Events With a Primary HIV-negative Partner)|"The outcome measure data shows the rate of change in the mean value in the number of total unprotected anal intercourse events over time. Behaviors were self-reported at each study visit using during the past 3 months as the recall period. Study visits took place at baseline, 3 month, and 6 month timepoints."|Self-reported behavior during past 3 months||||Self reported events in past 3 months|||Number
1398379|NCT01278953|Primary|Incidence of Device-related Early-onset Primary Serious Adverse Events|Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.|12 months||||participants|||Number
1398380|NCT01278953|Primary|Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter|Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.|12 months||||participants|||Number
1398381|NCT01278927|Secondary|Survival|Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.|6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
1398382|NCT01278927|Secondary|SF-36 Late Outcomes|The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|6 months||||units on a scale||Standard Deviation|Mean
1398383|NCT01278927|Secondary|Days of Hospitalization|The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.|100 days||||days||Standard Deviation|Mean
1398384|NCT01278927|Secondary|Nausea|Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.|100 days||||units on a scale||Standard Deviation|Mean
1398385|NCT01278927|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.|100 days||||units on a scale||Standard Deviation|Mean
1398386|NCT01278927|Secondary|Cancer and Treatment Distress (CTXD)|Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.|100 days||||units on a scale||Standard Deviation|Mean
1398387|NCT01278927|Primary|Functional Status|To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days||||units on a scale||Standard Deviation|Mean
1398388|NCT01278927|Secondary|Symptoms|Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.|100 days||||units on a scale||Standard Deviation|Mean
1398389|NCT01278797|Secondary|Time of Maximum Concentration of Amlodipine (TMAX)|Time of maximum measured amlodipine concentration over the zero to 72 hour sampling period|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial|||hours||Standard Deviation|Mean
1398390|NCT01278797|Primary|Maximum Observed Plasma Concentration (Cmax) of Amlodipine||Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial|||nanograms/milliliter||Standard Deviation|Mean
1398391|NCT01278797|Primary|Area Under the Concentration-time Curve of Plasma Amlodipine From 0 to 72 Hours (AUC72)|Area under the analyte concentration versus time curve from time zero to 72 hours as calculated by the linear trapezoidal method|Day 1, Day 22|Analysis Set includes all randomized participants who completed the trial|||nanograms*hour/milliliter||Standard Deviation|Mean
1398392|NCT01278745|Secondary|Post-transplant Safety Outcomes Among Participants: Safety and Tolerability of Rituximab|Defined as participants that experienced at least one adverse event that was possibly, probably, or definitely related to the study drug (i.e., Rituximab or Placebo). Serious adverse events were used to evaluate this endpoint and the attribution was based on the DAIT Medical Monitor's assessment.|Transplantation through end of study, up to 1 year post transplantation|Randomized participants|||Participants|||Count of Participants
1398393|NCT01278745|Secondary|Number of Participants With Post-transplant Incidence of PTLD|The number of participants experiencing at least one post-transplant lymphoproliferative disorder (PTLD) occurrence during this trial. Post-transplant lymphoproliferative disorder is an uncontrolled proliferation of B cell lymphocytes latently infected with Epstein-Barr virus.|Transplantation through end of study, up to 1 year post transplantation.|Randomized participants|||Participants|||Count of Participants
1398394|NCT01278745|Secondary|Number of Participants With Post-transplant Serious Infections Requiring Intravenous Antimicrobial Therapy|Number of participants experiencing at least one serious infection requiring intravenous antimicrobial therapy which is used to kill the growth of microorganisms such as bacteria, fungi, or protozoans.|Transplantation through end of study, up to 1 year post transplantation.|Randomized participants|||Participants|||Count of Participants
1398395|NCT01278745|Secondary|Number of Participants With Development of Angiographically Evident Cardiac Allograft Vasculopathy|Cardiac allograft vasculopathy is an aggressive form of atherosclerosis that is characterized by the development of fibrosis affecting cardiac arteries that result in concentric narrowing of the arteries and, ultimately allograft failure. Development of cardiac allograft vasculopathy can be diagnosed via an angiograph which is an X-ray of the cardiac arteries by injecting a radiopaque substance such as iodine.|1 year|Randomized participants|||Participants|||Count of Participants
1398396|NCT01278745|Secondary|Number of Participants With Episodes of Rejection Associated With Hemodynamic Compromise (HDC)|The number of participants that experienced at least one episode of rejection associated with hemodynamic compromise (HDC). Rejection associated with HDC is when there is insufficient blood flow to the transplanted heart in association with acute rejection found in a biopsy. Local biopsies were used for this outcome measure.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
1398397|NCT01278745|Secondary|Incidence of Any Treated Rejection|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection (AMR) of the transplanted heart regardless of the presence of a biopsy.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
1398398|NCT01278745|Secondary|Incidence of Cellular Rejection|Cellular Rejection refers to the organ recipient's immune system recognizing a transplanted organ as foreign and mounting a response to it via cellular mechanisms. Cellular rejection was defined as a biopsy which met The International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory|6 to 12 months|Randomized participants with at least one centrally read heart biopsy|||Participants|||Count of Participants
1398399|NCT01278745|Secondary|Incidence of AMR|The number of participants who experienced antibody- mediated rejection (AMR). Antibody-mediated rejection (AMR) occurs when the subject develops antibodies directed against the transplanted heart. This was assessed based on local pathology biopsy reads.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
1398400|NCT01278745|Secondary|Incidence of BPAR (Any Grade)|The number of subjects who experienced any grade of biopsy proven acute rejection (BPAR) within the clinical trial. Biopsy proven acute rejection is when an examination of tissue removed from the transplanted organ indicates that the subject’s immune system is trying to reject the graft. BPAR was defined as a biopsy which met The International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory.|6 to 12 months|Randomized participants with at least one centrally read heart biopsy|||Participants|||Count of Participants
1398401|NCT01278745|Secondary|Number of Episodes of Biopsy Proven Acute Rejection (BPAR) of Any Grade Per Participant|The number of times a participant experienced biopsy proven acute rejection (BPAR). Biopsy proven acute rejection is when an examination of tissue removed from the transplanted organ indicates that the subject’s immune system is trying to reject the graft. BPAR was defined as a biopsy that met the International Society for Heart & Lung Transplantation (ISHLT) criteria to be graded as 1R or greater rejection and was determined by a single, central pathology laboratory.|6 to 12 months|Randomized participants with at least one centrally read heart biopsy|||Participants|||Count of Participants
1398402|NCT01278745|Secondary|Re-transplantation or Re-listed for Transplantation|Re-transplantation is defined as the receipt of a subsequent heart transplant and re-listed for transplantation is being listed back on the heart transplant list to be re-transplanted.|6 to 12 months|Randomized participants|||Participants|||Count of Participants
1398403|NCT01278745|Secondary|Death|Participants who died within 12 months post-transplant|12 months|Randomized subjects|||Participants|||Count of Participants
1398404|NCT01278745|Primary|Change in Percent Atheroma Volume (PAV)|Nominal or noticeable change, bad or good, from baseline to 1 year in percent atheroma volume (PAV) which is a measure of the degree of coronary arterial obstruction due to host alloimmune processes measured by intravascular ultrasound (IVUS) in a target coronary artery. Thus a decrease in PAV would be an indicator of less obstruction and a better outcome.|Baseline, 1 year|Randomized participants with available data at year one|||percent||Standard Deviation|Mean
1398405|NCT01278615|Primary|Disease Control Rate (Complete Response [CR], Partial Response [PR], and Stable Disease [SD]) in Patients Treated With Selumetinib|Estimates of the disease control rate with the exact two-sided 95% confidence intervals. Response was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586. Using these criteria, ‘disease control rate’ encompassed patients who had either a CR, PR, and SD.|Up to 3 years||||percentage of disease control||95% Confidence Interval|Number
1398406|NCT01278615|Secondary|Time to Treatment Failure|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from study entry to treatment failure, defined as lymphoma progression or withdrawal from treatment due to adverse events, assessed up to 3 years. Patients who die without progression while still on therapy will be censored as of the time of death.||||days||95% Confidence Interval|Mean
1398407|NCT01278615|Secondary|Progression-free Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|Time from entry onto study until lymphoma progression or death from any cause, assessed up to 3 years||||days||95% Confidence Interval|Median
1398408|NCT01278615|Secondary|Overall Survival|The Kaplan-Meier procedure will be used to characterize the survivorship function. Median time-to-death and the corresponding two-sided 95% confidence intervals will be provided.|Date of study entry to the date of death, assessed up to 3 years||||days||95% Confidence Interval|Median
1398409|NCT01278615|Secondary|Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Percentage of patients experiencing any grade 3 or higher adverse event at least possibly attributed to the study drug. (Additional adverse event reporting will appear in the AE outcomes module.)|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
1398410|NCT01278615|Secondary|Duration of Response|The Kaplan-Meier procedure will be used to characterize the duration of response. Median time-to-event and the corresponding two-sided 95% confidence intervals will be provided.|From the documented beginning of response (CR or PR) to the time of relapse, assessed up to 3 years|Zero participants were analyzed due to no response.||||||
1398411|NCT01278615|Primary|Response Rate (Complete Response [CR] and Partial Response [PR]) in Patients Treated With Selumetinib|Estimates of the response rate based on best response (CR and PR) with the exact two-sided 95% confidence intervals. Response for this lymphoma clinical study was measured utilizing “Non-Hodgkins Lymphoma Response Criteria”. These criteria are based upon the criteria from the Revised Response Criteria for Malignant Lymphoma, (Cheson et al.), Journal of Clinical Oncology, 2007, Vol. 25:579-586.|Up to 3 years||||percentage of response||95% Confidence Interval|Number
1399156|NCT01270841|Primary|Change in Total Morning Testosterone|Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim|3 months|Intent to treat subjects with an assessment after baseline|||ng/dL||Standard Deviation|Mean
1398412|NCT01278485|Secondary|Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment|On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always.|Up to 12 Months Prior to Enrollment|All enrolled participants that completed the fear of weight gain questionnaire.|||Score on a Scale||Standard Deviation|Mean
1398413|NCT01278485|Secondary|Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment|Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable.|Up to 12 Months Prior to Enrollment|All enrolled participants|||Participants|||Number
1398414|NCT01278485|Secondary|Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment|Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia.|Day of Enrollment|All enrolled participants that completed the worry scale of the HFS II.|||Score on a Scale||Standard Deviation|Mean
1398415|NCT01278485|Primary|Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment|Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Day of Enrollment|All enrolled participants with a hemoglobin A1c measurement collected on the day of enrollment.|||Participants|||Number
1398416|NCT01278485|Secondary|Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment|The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never.|Day of Enrollment|All enrolled participants that completed a questionnaire on the day of enrollment.|||Score on a Scale||Standard Deviation|Mean
1398417|NCT01278485|Secondary|Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment|The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life.|Day of Enrollment|All enrolled participants that completed the TSQM on the day of enrollment.|||Score on a Scale||Standard Deviation|Mean
1398418|NCT01278485|Secondary|Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment|Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health).|Day of Enrollment|All enrolled participants with a completed EQ-VAS questionnaire.|||Score on a Scale||Standard Deviation|Mean
1398419|NCT01278485|Secondary|Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment|The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Day of Enrollment|All enrolled participants with a completed EQ-5D questionnaire.|||Score on a Scale||Standard Deviation|Mean
1398420|NCT01278485|Primary|Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment|At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.|Up to 6 Months Prior to Enrollment|All enrolled participants that experienced hypoglycemia in the prior 6 months.|||Participants|||Number
1398421|NCT01278485|Primary|Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment|The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.|Up to 6 Months Prior to Enrollment|All enrolled participants.|||Participants|||Number
1398422|NCT01278407|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score|The NPI was a questionnaire that quantified psychiatric symptoms and behavioral disorders in dementia. A total of 12 items (the original NPI-10 consisting of 10 behavioral domains: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor behavior, supplemented by 2 dementia with Lewy bodies (DLB)-relevant domains of sleep, and cognitive fluctuation [reported as cognitive fluctuation inventory]) were assessed. The score of each item was calculated as frequency (scale: 1=occasionally to 4=very frequently) x Severity (scale: 1=Mild to 3=Severe). The NPI-2 was calculated as the sum of the scores for hallucinations and cognitive fluctuation, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicated improvement. Data are presented as change from baseline in mean NPI-2 +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.|||Units on a scale||Standard Deviation|Mean
1398423|NCT01278407|Primary|Change From Baseline in Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. Data are presented as change from baseline in mean MMSE +/- standard deviation.|Week 12 for Confirmatory Phase|Full Analysis Set: Efficacy was analyzed in the full analysis set, including the randomized participants who received the study drug at least once and had valid efficacy assessment data at more than one point.|||Units on a scale||Standard Deviation|Mean
1398424|NCT01278394|Secondary|Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG|Length of time to clinical evaluation of clear or at least 5 mm of CNG.|Baseline to 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||days||95% Confidence Interval|Mean
1398425|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
1398426|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 270|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
1398427|NCT01278394|Secondary|Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 180|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
1398428|NCT01278394|Secondary|Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline|Number of subjects with negative KOH, and number of subjects with negative fungal cultures.|Day 90|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||participants|||Number
1398429|NCT01278394|Secondary|Clear Nail Growth of the Targeted Toenail|Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the LOCF was used to impute missing observations.|||millimeters||95% Confidence Interval|Mean
1398430|NCT01278394|Primary|Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360|Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.|Day 360|Efficacy data were analyzed for the ITT population. For efficacy variables, the last observation was carried forward (LOCF) to impute missing observations.|||participants|||Number
1398431|NCT01278342|Secondary|The Percentage of Participants With Partial Response (PR) at 8 Months|"Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment.~Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range.~Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR|||percent||95% Confidence Interval|Number
1398432|NCT01278342|Secondary|The Percentage of Participants With Complete Response (CR) At 3 Months|"A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment:~Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and~IGF-I within the Central Laboratory Normal Range (for age and gender)"|From Baseline to 3 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR|||percent||95% Confidence Interval|Number
1398433|NCT01278342|Primary|The Percentage of Participants With Complete Response (CR) at 8 Months|"A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment:~Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and~IGF-I within the Central Laboratory Normal Range (for age and gender)."|From Baseline to 8 months|Intent-to-Treat population - all participants receiving at least one dose of Sandostatin LAR|||percent||95% Confidence Interval|Number
1398434|NCT01278303|Secondary|Secondary Safety Outcomes - Adverse Events|"Secondary Safety Outcomes~The proportion of patients experiencing any serious or somewhat serious adverse event related to the stent or implant procedure by 24 months follow up, such as: new aortic wall injury within the region of covered CP Stent implantation, stent malposition, stent fracture, aortic wall aneurysms (early or late), or restenosis requiring reintervention, arterial access site injury, bleeding, etc."|2 years||||percentage of participants|||Number
1398435|NCT01278303|Secondary|Secondary Efficacy Outcomes - 1 Year|"Secondary Efficacy Outcomes~At One Year: (A) Number of participants with arm-leg systolic blood pressure (SBP) differences <15 mmHg and (B) Number of participants with normal or only mildly elevated SBP, no more than mild arm-leg SBP, no clinically significant residual aortic wall injury AND no worsening in any of these three categories"|1 years||||participants|||Number
1398451|NCT01277822|Secondary|Change From Baseline in Ankle Circumference at Week 8|Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.|Baseline and Week 8|All participants who received at least 1 dose of study drug and had available data for ankle circumference.|||mm||Standard Deviation|Mean
1398558|NCT01276756|Secondary|End-of-treatment Response|An end-of-treatment response is defined as a negative HCV PCR at 48 weeks after the start of pegylated interferon and ribavirin|48 weeks +- 7 days after starting pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.|||participants|||Number
1399218|NCT01270620|Secondary|- Time to Following Command After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
1398436|NCT01278303|Primary|Study Participants With Grade 4 or 5 in Degree of Aortic Wall Injury (AWI) and/or Aortic Arch Obstruction Without Clinical Worsening|"Severity of Illness Scale (SIS) improvement increase of at least 1 grade from baseline to 12 month follow-up~SIS is divided into 3 conditions & 5 grades of severity: 1 = worst (reserved for AWI) , 5 = best) C1 Upper Extremity Systolic Blood Pressure (SBP) 2- > 159 mmHg or any hpn on >2 medications 3- 140-159 mmHg or elevated SBP on >2 medications 4- 130-139 mmHg or normal SBP on >2 medications 5- <130 mmHg on 0-2 meds~C2 Upper Extremity to Lower Extremity SBP difference 2- >59 mmHg 3- 30-59 mmHg 4- 15-29 mmHg 5- <15 mmHg~C3~Aortic Wall Injury severity levels:~Uncontained rupture or large aneurysm~Contained rupture or stable large aneurysm~Small contained rupture or moderate aneurysm~Acute, but stable AWI or small aneurysm~No injury or minor aortic wall irregularity not in need of treatment.~Grades for conditions represent comparable degrees of illness (0 worst, 5 best) -Grade 0 denotes death related to coarctation or study therapy"|Baseline and 12 months|Participants available for analysis at one year|||participants|||Number
1398437|NCT01278173|Primary|Change From Reference Value in Average RNFL (Retinal Nerve Fiber Layer) Thickness (µm) as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography)|Mean change from the reference value in average RNFL thickness (µm) as measured by SD-OCT. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). Thinning of the RNFL, that is, a negative change from the reference value, has been associated with ophthalmological disease.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of IMP and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).|||µm||Standard Deviation|Mean
1398438|NCT01278173|Primary|Mean Change From Reference Value in Field Width as Measured by 30-2 SITA Fast in Field Sensitivity (Mean Deviation - MD in dB)|Mean change from the reference value in 30-2 SITA mean deviation, which was generated using the University of Iowa Visual Field Reading Center (VFRC) normative database and the Humphrey Field Analyzer (HFA) normative database. The reference value was defined as the average of the assessments performed at Visits 1 (baseline), 2 and 3 (first month of dosing). The mean change from the reference value are presented for Months 3, 6, 9 and 12. A negative change from the reference value indicates a decrease in the central visual field.|Baseline (Month 0), Month 3, Month 6, Month 9, Month 12|All patients who had received at least one dose of investigational medicinal product and who had a valid reference value assessment and at least one valid post-reference value assessment. The total number of patients included in the analysis set was 55. The actual number of patients analysed for each time point and eye is presented below (N = x).|||dB||Standard Deviation|Mean
1398439|NCT01278160|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).|Weeks 0-16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||episodes|||Number
1398440|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage of subjects|||Number
1398441|NCT01278160|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage of subjects|||Number
1398442|NCT01278160|Secondary|9-point SMPG (Self Measured Plasma Glucose) Profile|A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day|Week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||mmol/L||Standard Error|Least Squares Mean
1398443|NCT01278160|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline||Week 0, week 16|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s). Six patients discontinued trial without any post randomisation HbA1c measurements.|||percentage of glycosylated haemoglobin||Standard Deviation|Least Squares Mean
1398444|NCT01278030|Primary|Responder Rate|The responder rate is defined as the proportion of patients with reduction in end systolic volume greater than or equal to 15%. The primary endpoint is the responder rate.|At 6 month follow-up|Patients who completed the 6 month follow-up with implant 3D echo data.|||percentage of participants|||Number
1398445|NCT01277887|Secondary|Sleep Efficiency|Self-reported sleep efficiency subscale of the Pittsburgh Sleep Quality Index. This is calculated as the percentage of total time spent asleep in a night compared to the total time spent in bed, multiplied by 100.|Change from Baseline at 4 weeks||||percentage of time asleep in bed||Standard Deviation|Mean
1398446|NCT01277887|Secondary|Self-Control to Resist Smoking Cues|To develop an effect size estimate for changes in self-control to resist smoking cues from baseline to the day before quitting smoking comparing smokers in the two counseling conditions.|4 Weeks|These data were not collected.||||||
1398447|NCT01277887|Primary|Smoking Abstinence|"Smoking abstinence is operationally defined as no smoking on the last 7 days of the last week of treatment. And no smoking within the last 7 days at the first follow-up visit 4 weeks after completing treatment."|1 Week||||participants|||Number
1398448|NCT01277861|Secondary|Coughing|Data include patients who coughed irrespective of the degree of coughing.|Intraoperative period|Per protocol|||Participants, number|||Number
1398449|NCT01277861|Secondary|Apnea|Apnea defined as no breathing for at least 30 s.|Induction of Anesthesia|Per protocol|||Participants, number|||Number
1398452|NCT01277822|Secondary|Percentage of Participants Who Had Peripheral Edema During the Study|A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.|up to 8 weeks|Safety Set defined as all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1398453|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 4|Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||Percentage of Participants|||Number
1398454|NCT01277822|Secondary|Percentage of Participants Who Achieve Target Blood Pressure at Week 8|Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.|Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||Percentage of Participants|||Number
1398455|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4|Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
1398456|NCT01277822|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
1398457|NCT01277822|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4|Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 4|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
1398458|NCT01277822|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.|Baseline and Week 8|Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.|||mmHg||Standard Deviation|Mean
1398459|NCT01277757|Primary|Number of Participants With Objective Response|Only those participants who have measurable disease present at baseline, have received at least four doses of MK2206, and have had their disease re-evaluated will be considered evaluable for response. Response classified according the RECIST definitions, and re-evaluated for response every 12 weeks. (Note: Participants who exhibit objective disease progression prior to receiving four doses of therapy will also be considered evaluable.) In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response, and then revert to scheduled repeat imaging.|4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.|||participants|||Number
1398460|NCT01277757|Secondary|Apoptosis Assessed by Cleaved Caspase-3|Assessment of apoptosis by immunohistochemistry to active caspase-3.|Up to 30 days after completion of study treatment, up to 1 year|||||||
1398461|NCT01277757|Secondary|Cell Proliferation as Measured by the Change in Percent Ki-67 Positive Cells|Ki-67 will be scored as % positive cells to determine whether there is a change % Ki-67+ cells before treatment versus after 2 weeks of treatment.|Baseline to 2 weeks|||||||
1398462|NCT01277757|Secondary|Median Response Duration|"The duration of the response is from the time response is achieved until disease progression is detected. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.~Response re-evaluated every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-6 weeks following initial documentation of objective response."|Response assessment 4 weeks from beginning of treatment, response recorded from the start of treatment until disease progression/recurrence, up to 1 year|Two participants were not treated, and one was inevaluable.|||months||Full Range|Median
1398463|NCT01277757|Secondary|6 Month Progression-free Survival (PFS)|Number of participants progression free at 6 months. PFS is defined as the duration of time from start of treatment, or time of progression or death, whichever occurs first. The PFS for this outcome was assessed at 6 months post treatment.|From start of treatment to time of progression or death or six months whichever occurs first, assessed at 6 months||||participants|||Number
1398464|NCT01277757|Primary|Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)|Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Up to 3 weeks after completion of study treatment, for up to 1 year|Two participants were not treated therefore excluded from study population analysis, another was inevaluable and six others were not analyzable for response.|||participants|||Number
1398465|NCT01277718|Primary|Maximum Observed Concentration of Cobimetinib||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1398466|NCT01277718|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1398467|NCT01277666|Secondary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 12|The Safety population comprised of all participants in the intent to treat population except those who did not take at least one dose of investigational product.|||Participants|||Number
1398468|NCT01277666|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12|The IBDQ is a 32-item IBD-specific health related quality of life instrument evaluating general activities of daily living, intestinal function, social performance, personal interactions, and emotional status. Each item response was graded from 1 to 7 for each area evaluated. A higher score indicated better function in that area. Total IBDQ score was obtained by summing up scores for all 32 questions. Total IBDQ score ranged from 32 to 224. A higher score indicated better quality of life and lower score indicated worse quality of life. Day 1 assessment was considered as Baseline. Change from Baseline was calculated by subtracting value at Baseline from value at Weeks 8 and 12.|Baseline (Week 0), Week 8 and Week 12|Intent to treat population. Only those participants available at specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1398469|NCT01277666|Secondary|Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8|Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants achieving clinical remission with CDAI <150 points at Week 8 was presented.|Week 8|Intent to treat population.|||Percentage of participants||95% Confidence Interval|Number
1398470|NCT01277666|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8|CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participant’s condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of Participants with a clinical response CDAI decrease from baseline of >=100 points at Week 8 was presented.|Week 8|Intent to treat population.|||Percentage of Participants||95% Confidence Interval|Number
1398471|NCT01277666|Secondary|Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12|Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission defined as a CDAI score of less than 150 points at other time points was presented.|Week 8 and 12|Intent to treat population.|||Percentage of participants||95% Confidence Interval|Number
1398472|NCT01277666|Secondary|Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12|Responders were defined as participants with CDAI decrease from baseline of >= 100 points. CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participant’s condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI decrease from baseline of >=100 points was presented.|At Week 8 and 12|Intent to treat population|||Percentage of participants||95% Confidence Interval|Number
1398473|NCT01277666|Secondary|Percentage of Participants With CDAI Remission at Week 12|CDAI is a recognized scoring system to categorize disease severity with scores of >= 220 to <= 450 describing the moderately-to-severely active population. Clinical remission is defined as a CDAI score < 150 points if baseline CDAI is >= 150. If baseline CDAI is <150, the participant was not considered in remission. Participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission at Week 12 was presented.|Week 12|Intent to treat population.|||Percentage of participants||95% Confidence Interval|Number
1398474|NCT01277666|Primary|Percentage of Participants With Crohn’s Disease Activity Index (CDAI) Response at Week 12|CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participant’s condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.|Week 12|The intent to treat population comprised of all participants randomized to double-blind treatment for 12 weeks.|||Percentage of participants||95% Confidence Interval|Number
1398475|NCT01277601|Secondary|Percentage of Participants Who Required Retreatment|Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.|Up to 120 weeks|Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.|||percentage of participants|||Number
1398476|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 120|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1398477|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 96|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1398478|NCT01277601|Secondary|Percentage of Participants With Normal ALT at Week 72|"Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT).~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1398479|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Week 120|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1398480|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Week 96|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1398481|NCT01277601|Secondary|Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72|"For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Week 72|Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1398494|NCT01277549|Primary|Mononuclear Cell Collection Efficiency|The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|One day|Results are given for all per protocol subjects.|||% of processed MNCs that were collected||Full Range|Median
1398559|NCT01276756|Secondary|Early Virological Response|"A complete early virologic response is defined as a negative HCV PCR 90 days after the start of pegylated interferon.~A partial early virologic response is defined as a decrease of 2 or more log in HCV PCR at 90 days after the start of pegylated interferon"|90 ± 7 days from the start of pegylated interferon and ribavirin|ITT. Any patient who received at least one dose of interferon was included in the analyses.|||participants|||Number
1398482|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 120|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120."|Baseline; Week 120|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.|||percentage of participants|||Number
1398483|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 96|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96."|Baseline; Week 96|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.|||percentage of participants|||Number
1398484|NCT01277601|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 72|"Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit.~For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72."|Baseline; Week 72|Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.|||percentage of participants|||Number
1398485|NCT01277601|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120|"HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120."|Baseline; Weeks 72, 96, and 120|Full Analysis Set|||percentage of participants|||Number
1398486|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Weeks 96 and 120|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis."|Baseline; Weeks 96 and 120|Full Analysis Set|||percentage of participants|||Number
1398487|NCT01277601|Secondary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.|||percentage of participants|||Number
1398488|NCT01277601|Primary|Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone|"Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate.~The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis."|Baseline; Week 72|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.|||percentage of participants|||Number
1398489|NCT01277549|Primary|CD34+ Cell Collection Efficiency|The collection efficiency for CD34+ cells is defined as the percent of processed CD34+ cells that were in fact collected.|one day|Results are given for all per protocol subjects.|||% of processed CD34+ cells collected||Full Range|Median
1398490|NCT01277549|Secondary|Viability of the Collected MNC Product|The viability of the collected white blood cells was assessed using the 7-AAD (7-amino actinomycin D) viability dye in a flow cytometric assay. Viability assessment is incorporated into the CD34 assay. This assay was only performed on G-CSF mobilized donors as nonmobilized donor have too few CD34+ cells to detect. Thus viability of the collected WBCs is reported only for the G-CSF mobilized arm.|One day|Per Protocol|||percentage of total WBCs collected||Full Range|Median
1398491|NCT01277549|Secondary|Granulocyte % of MNC Product|Granulocyte contamination of the MNC product was quantitated as the percent of total product WBC (white blood cell) that were segmented granulocytes or bands.|One day|Results given for all per protocol subjects.|||percentage of WBCs collected||Full Range|Median
1398492|NCT01277549|Secondary|Hematocrit of MNC Product|The hematocrit of the collected product was used to quantitate RBC (red blood cell) contamination.|One Day|Per protocol|||RBC % of product volume||Full Range|Median
1398493|NCT01277549|Secondary|Platelet Collection Efficiency|Platelet contamination of the cell product was measured as the platelet collection efficiency, that is, as the percent of platelets processed that were collected.|One Day|Per protocol|||% of processed platelets collected||Full Range|Median
1399219|NCT01270620|Secondary|- Time to Tracheal Extubation After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
1398495|NCT01277523|Secondary|Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests|Clinically relevant abnormalities for physical examination, ECG, vital signs and laboratory tests. New abnormal findings or worsening of baseline conditions were reported as adverse events.|From first drug administration until 30 days after last drug intake, up to 142 days|Treated set which included all randomised patients who were dispensed and received, at least one documented dose of trial medication.|||percentage of participants|||Number
1398496|NCT01277523|Secondary|Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.|Time in days to first asthma exacerbation during the 12 week treatment period. The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.|||participants|||Number
1398497|NCT01277523|Secondary|Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.|"Time in days to first severe asthma exacerbation during the 12 week treatment period. The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values.~A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required an initiation of treatment with systemic corticosteroids for at least 3 days or, in case of ongoing and pre-existing systemic corticosteroid therapy, requiring at least doubling of previous daily doses of systemic corticosteroids for at least 3 days."|12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.|||participants|||Number
1398498|NCT01277523|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.~Measured values presented are actually adjusted means"|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1398499|NCT01277523|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1398500|NCT01277523|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 12.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data was imputed by the available data from the patient. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
1398501|NCT01277523|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ total score responders.~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data for patients not withdrawn from the study were either categorised as no change or based on available data. Withdrawn patients were imputed based upon discontinuation reason.|||percentage of participants|||Number
1398502|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 12.~The ACQ is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||units on a scale||Standard Error|Mean
1398503|NCT01277523|Secondary|ACQ6 Score Responders|"Responder rates based on the ACQ6 score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline <= -0.5), no change (-0.5 < change from trial baseline <0.5) and worsening (change from trial baseline >= 0.5).~The ACQ is a scale containing 7 questions, each question has a 7- point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 is calculated as the mean of the responses to the first 6 questions of the ACQ6.~No statistical testing was performed on ACQ6 responders."|12 weeks|"Full Analysis Set which included all randomised patients who were dispensed and received at least one documented dose of trial medication.~Missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason."|||percentage of participants|||Number
1398543|NCT01277042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade.|During the 7 days (Days 0 – 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1398504|NCT01277523|Secondary|Control of Asthma as Assessed by ACQ6 Score.|"Change from baseline in Asthma Control Questionnaire (ACQ) 6 score measured at week 12~The ACQ is a scale containing 7 questions, each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ6.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||units on a scale||Standard Error|Mean
1398505|NCT01277523|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||litres||Standard Error|Mean
1398506|NCT01277523|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC 0–3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1398507|NCT01277523|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak0–3h) after 12 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
1398508|NCT01277523|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||litres||Standard Error|Mean
1398509|NCT01277523|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||litres||Standard Error|Mean
1398510|NCT01277510|Secondary|Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; only participants with available data were included in the analysis.|||percent change||95% Confidence Interval|Least Squares Mean
1398511|NCT01277510|Secondary|Growth Velocity From End of Double-blind Phase to End of Open-label Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.|End of double-blind phase (Week 30) until end of the open-label phase (Week 60)|Full analysis set. Only participants with available data were included in the anaysis.|||cm/year||Standard Deviation|Mean
1398512|NCT01277510|Secondary|Growth Velocity From Baseline to End of Double-blind Phase|Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.|From Baseline to end of Efficacy Assessment at Week 30|Full analysis set; the last assessment in the double-blind phase was used due to the early termination of the study. Only participants with available data are included in the analysis.|||cm/year||95% Confidence Interval|Least Squares Mean
1398513|NCT01277510|Secondary|Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks|Full analysis set|||percent change||95% Confidence Interval|Least Squares Mean
1398560|NCT01276756|Secondary|Rapid Virological Response|A rapid virologic response is defined as a negative HCV PCR 4 weeks after treatment|28 - 33 days after start of Pegylated interferon and ribavirin|"Only 1 patient in standard of care arm and 3 patients in the triple therapy arm missed doing the PCR test at week 4. These patients were thus not included in this particular analysis."|||participants|||Number
1398514|NCT01277510|Secondary|Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set; data for one participant in the Placebo group were not available.|||percent change||95% Confidence Interval|Least Squares Mean
1398515|NCT01277510|Secondary|Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period|"Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 – Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."|From Baseline to the Efficacy Assessment Phase, Weeks 25-30.|Full analysis set|||percent change||95% Confidence Interval|Least Squares Mean
1398516|NCT01277510|Secondary|Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30|Full analysis set|||pecentage of participants|||Number
1398517|NCT01277510|Primary|Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase|The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.|From Baseline to the Efficacy Assessment Phase, Weeks 25-30|Full analysis set, which includes all randomized participants with at least 1 post-baseline assessment.|||percentage of participants|||Number
1398518|NCT01277354|Primary|CPT Effectiveness as Determined by the Number of Participants With CAPS Score Decrease of 50% From Baseline to Week 6|The CAPS will be used in the diagnosis of PTSD, assessment of the impact of symptoms on function, assessment of the severity of symptoms at baseline, and weekly throughout the study. The CAPS in this particular study must decrease by 50% for CPT to be deemed effective.|6 weeks|Please note that there were only a total of 2 participants involved in this study. Funding was lost to continue and the study was terminated.|||Participants|||Count of Participants
1398519|NCT01277302|Secondary|Percentage of Participants With Intraretinal Edema|The presence of intraretinal edema was defined as the presence of subretinal fluid, cystoid spaces, or central retinal thickness ≥ 300 µm as evaluated in spectral-domain optical coherence tomography images by the Digital Angiography Reading Center, the central reading center. At baseline, all participants in the Monthly and PRN groups had presence of edema.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
1398520|NCT01277302|Secondary|Mean Change From Baseline in Central Foveal Thickness|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||µm||Standard Deviation|Mean
1398521|NCT01277302|Secondary|Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm|Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness > 300 µm at baseline.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
1398522|NCT01277302|Secondary|Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
1398523|NCT01277302|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.|Month 1 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Letters||Standard Deviation|Mean
1399220|NCT01270620|Secondary|- Time to Eye Opening After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
1399221|NCT01270620|Secondary|- Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation||first day||||seconds||Inter-Quartile Range|Median
1398524|NCT01277302|Secondary|Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better|VA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
1398525|NCT01277302|Secondary|Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Month 7 to Month 15|Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.|||Percentage of participants||95% Confidence Interval|Number
1398526|NCT01277302|Secondary|Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. This outcome measure is not relevant for subjects in the non-randomized group because they never met the VA-OCT stability criteria.|Month 7 through Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.|||Letters||Standard Deviation|Mean
1398527|NCT01277302|Primary|Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15|BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.|Baseline to Month 15|Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the Monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.|||Letters||Standard Deviation|Mean
1398528|NCT01277211|Secondary|Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle|Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.|||Percentage of participants|||Number
1398529|NCT01277211|Secondary|Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle|"Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING."|Up to 1 year|ITT Group, which consisted of all randomized participants who used at least one ring/pill.|||Percentage of participants|||Number
1398530|NCT01277211|Primary|Pearl Index, by Treatment Group|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).|Up to 1 year|Restricted Intent-to-Treat (R-ITT) Group, which consisted of all participants from the Intent-to-Treat (ITT) Group who had at least one cycle at risk (no condom use and confirmed intercourse).|||Pregnancies per 100 woman-years||95% Confidence Interval|Mean
1398531|NCT01277159|Primary|Time it Takes for Nerve Block to Wear Off|Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?|up to 72 hours||||hours||Standard Deviation|Mean
1398532|NCT01277081|Secondary|Overall Cold Symptoms Score|Overall cold symptom score was assessed by asking the question “my cold symptoms are improved” only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’.|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Error|Mean
1398533|NCT01277081|Secondary|Soothing Attribute Scores|Soothing attribute of test treatment was assessed by asking the question “if the hot drink is soothing” at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’.|Baseline to 15 and 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Deviation|Mean
1398544|NCT01277042|Secondary|Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies|Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1398534|NCT01277081|Secondary|Cold Symptoms Score Post 60 Minutes|A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. “My head feels clear”, “I feel soothing in my throat” and “I feel my cough is being soothed”. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 60 minutes|ITT population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||95% Confidence Interval|Mean
1398535|NCT01277081|Secondary|Cold Symptoms Score Post 15 Minutes|A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. “My head feels clear”, “I feel soothing in my throat” and “I feel my cough is being soothed”. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 15 minutes|ITT Population: all randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||95% Confidence Interval|Mean
1398536|NCT01277081|Secondary|Breathing Score Post 60 Minutes|A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. “my breathing feels easy”, “I feel airways are open”, “I feel a cooling sensation in my throat”, “I can feel the air flowing to my lungs easily”, “My nose feels less blocked” and “I feel my breathing is comfortable”. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 60 minutes|ITT population: All randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a scale||95% Confidence Interval|Mean
1398537|NCT01277081|Primary|Breathing Scores Post 15 Minutes|A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. “my breathing feels easy”, “I feel airways are open”, “I feel a cooling sensation in my throat”, “I can feel the air flowing to my lungs easily”, “My nose feels less blocked” and “I feel my breathing is comfortable”. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.|Baseline to 15 minutes|Intent to Treat (ITT) Population: All randomized participants who had at least one post-baseline efficacy evaluation.|||Score on a Scale||95% Confidence Interval|Mean
1398538|NCT01277042|Secondary|Number of Subjects With Outcome of Pregnancies|The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, solely on subjects with outcome of pregnancies.|||Participants|||Count of Participants
1398539|NCT01277042|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)|MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1398540|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 – 29) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1398541|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1398542|NCT01277042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination.|During the 7 days (Days 0 – 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1398545|NCT01277042|Secondary|Number of Subjects Seropositive Against HPV-16 and HPV-18|A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.|Before vaccination (Month 0) and one month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1398546|NCT01277042|Primary|Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18|A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.|One month after third vaccination (Month 7)|The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1398547|NCT01276847|Secondary|Change From Baseline in Gene Expression Score for Interleukin 17 (IL-17) in Psoriatic Lesions of Participants Treated With Etanercept|Participants had skin biopsies performed at baseline and after treatment with etanercept for 1,2,4 and 16 weeks. The expression of IL-17 mRNA was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Etanercept.|||Gene expression score||90% Confidence Interval|Median
1398548|NCT01276847|Secondary|Change From Baseline in Composite Gene Expression Score Based on Interleukin 23 (IL-23) Pathway Related Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The mRNA expression of eight pre-defined IL-23 pathway related genes, namely beta 4 defensin (DEFB4), CXC motif chemokine 8 (CXCL8), Interleukins 17A, 17F, 20, 22, 23A (IL-17, IL-17F, IL-20, IL-22, IL-23A) and cyclic AMP dependent protein kinase (CAMP) was quantitated by qPCR, with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a reduction from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.|||Gene expression score||90% Confidence Interval|Median
1398549|NCT01276847|Primary|Change From Baseline in Composite Gene Expression Score Based on IL-12 Pathway Related Interferon Gamma (IFN-γ)-Modulated Genes in Psoriatic Lesions of Participants Treated With Ustekinumab|Skin biopsies were collected from participants at baseline and after treatment with ustekinumab for 1,2,4 and 16 weeks. The expression of messenger RNA (mRNA) from three pre-defined IL-12 pathway related genes, modulated by interferon gamma (IFN-γ), namely IFN-γ, inducible nitric oxide synthase(iNOS) and CXC motif chemokine 10(CXCL10) was quantitated by real-time polymerase chain reaction (qPCR), with the data normalized by the delta-delta Ct method. The expression score for each gene, showing the percentage difference from baseline, was calculated as follows : [(baseline - post baseline)/baseline] x 100. Composite gene expression scores were derived for each individual by summing the expression scores of the individual genes. Positive composite scores denote a decrease from baseline in gene expression.|Baseline and Weeks 1, 2, 4, and 16|Pre-specified to be collected only in participants treated with Ustekinumab. One participant treated with Ustekinumab with extreme outlying data, likely due to mislabeling of lesional and nonlesional tissues, was excluded from the analysis.|||Gene expression score||90% Confidence Interval|Median
1398550|NCT01276821|Other Pre-specified|Average Duration of Crying (in Minutes) Among Babies Receiving Nebulisation Therapy.|The outcomes tries to compare the influence of duration of crying among babies receiving nebulization which interferes with drug delivery and henceforth might create a confounding bias while interpreting results.|2 hours||||Minutes||Standard Deviation|Mean
1398551|NCT01276821|Secondary|Persistence of Cough at the End of 1 Week|Number of patients in each intervention group whose parents reported the persistence of initial cough at the end of 1 week in their children.|7 days||||participants|||Number
1398552|NCT01276821|Secondary|Missed Days of Work of Caregivers|Number of patients in each intervention group whose parents reported at least 1 day of missed work due to the illness of child within the week following the initial hospital visit on 7 day follow-up call.|7 days||||participants|||Number
1398553|NCT01276821|Secondary|Need for Unscheduled Medical Visits, if Any, for Same Symptoms to Any Healthcare Facility Within 1 Week||7 days||||participants|||Number
1398554|NCT01276821|Secondary|Relapse Rate|To study the number of patients in either group who need another unscheduled medical visit within the initial 24 hours of ER/ OPD visit|24 hours||||Participants|||Number
1398555|NCT01276821|Secondary|Patients Meeting Eligibility Criteria for ER/ OPD Discharge at the End of 2 Hours of Observation||At the end of 2 hours||||participants|||Number
1398556|NCT01276821|Primary|Mean Change in Clinical Severity Score|"Mean changes in the Clinical Severity Score after 2 sessions of nebulisation as compared to baseline.~Clinical Severity Score devised by Wang et al, is an objective scoring system that measures the degree of respiratory distress in young children.~The scoring system assesses respiratory rate, wheezing, retraction, and general condition,scores ranging from 0 to 3, with higher scores indicating severe illness and vice versa.~The total scores range from 0 to 12, with increased severity receiving a higher score (Wang et al, 1992).~This scoring systems have previously been validated in a number of well designed randomized controlled trials(Anil 2010, Kuzik 2007, Sarrell 2002, and Mandelberg 2003). A 1 point improvement in the clinical severity score implies approximately 7% betterment of symptoms on the scale."|2 hours||||units on a scale||Standard Deviation|Mean
1398561|NCT01276756|Primary|Sustained Virologic Response|sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)|180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).|All was intention-to-treat (ITT) analysis. Any patient who received at least one dose of interferon was included in the analyses.The only 2 dropouts (lost to follow-up) were calculated as failures.|||participants|||Number
1398562|NCT01276652|Post-Hoc|Presence of Normal Spectral Edge Frequency 95% (SEF95) Activity|SEF95 is normally higher during wakefulness during sleep. The normal sleep SEF95 profile is rhythmic with an approximately 90 minute periodicity. We analyzed the number of subjects who exhibited this normal profile.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.|||Participants|||Count of Participants
1398563|NCT01276652|Post-Hoc|Presence of Normal Slow Wave Activity|Slow wave activity in health exhibits diurnal and ultradian periodicity and a homeostatic decline at night. The number of subjects exhibiting these characteristics was calculated for each group.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.|||Participants|||Count of Participants
1398564|NCT01276652|Other Pre-specified|Normal Timing of 6-sulfatoxymelatonin Excretion|The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.|Average 4 days (patients followed to hospital discharge)|24-hour 6-sulfatoxymelatonin profiles were successfully collected in 16 subjects total. In one subject in the usual care (observational) group, there were insufficient data to determine melatonin timing.|||Participants|||Count of Participants
1398565|NCT01276652|Other Pre-specified|Occurrence of REM Sleep|Occurrence of identifiable rapid eye movement (REM) sleep in each subject.|Average 4 days (patients followed to hospital discharge)|In one subject in the environmental modification group, the files were lost after acquisition and this analysis was unable to be performed.|||Participants|||Count of Participants
1398566|NCT01276652|Secondary|Subject Tolerance of the Environmental Modification Protocol|This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.|Average 4 days (patients followed to hospital discharge)|Only subjects who received the intervention were assessed.|||Subjects who tolerated the protocol|||Number
1398567|NCT01276652|Primary|Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours.|This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.|Average 4 days (patients followed to hospital discharge)||||Participants|||Count of Participants
1398568|NCT01276639|Secondary|Family Dermatology Life Quality Index (FDLQI) Score|The FDLQI is a 10-item questionnaire that examine the impact of health-related quality of life issues associated with living with a person with a skin condition (example, emotional distress, personal relationships, reactions of other people, social life, caregiving) over the last month. The FDLQI need to be completed by a family member (for example, spouse or partner, parent) who currently lives with the participant. Each question is scored on a scale from 0 (Not at all/ Not relevant) to 3 (Very much). Total score is calculated by summing the score of each item resulting in a maximum score of '30' and a minimum score of '0'. Higher scores indicate greater impairment to quality of life.|Baseline, Week 16, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398569|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants rate how much psoriasis affected their ability to work by reporting a number from 0 to 10, where 0 means “ability to work was not affected by psoriasis”, and 10 means “ability to work was completely affected by psoriasis”. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398585|NCT01276639|Secondary|Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1398570|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Percent absent hours = (hours absent from work/hours scheduled to work) multiplied by 100. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||percentage of scheduled hours||Standard Deviation|Mean
1398571|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Baseline is the latest pre-dose measurement. Participants reported hours scheduled to work and hours absent from work. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for specified parameter for each arm, respectively.|||hours||Standard Deviation|Mean
1398572|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use, and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Percentage of participants reporting healthcare resource use events and employment status, work impacted events due to psoriasis, and absence or sick leave for work due to psoriasis at Week 16 are reported. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable (answered respective question for this measure) for specified parameter for each arm, respectively.|||percentage of participants|||Number
1398573|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work|"The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work. Participants employed at the time of assessment answered (Yes/No [Y/N]): Were you absent or on sick leave from work due to psoriasis today?, and participants unemployed (UEmp) at the time of assessment answered (Yes/No): Are you unemployed due to your psoriasis? Baseline is the latest pre-dose measurement. Week 16 includes all reported log up to Week 16 (excluding Baseline). Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint."|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||participants|||Number
1398574|NCT01276639|Secondary|Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners, Dermatologist, Rheumatologist). Baseline is the latest pre-dose measurement. Week 16 includes all reported log data to Week 16 (excluding Baseline). Participants may have response in more than 1 category. Data was not analyzed beyond Week 16 as per study team’s decision because Week 0 - 16 period was considered sufficient to provide clear reflection of Ps-HCRU endpoint.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||events|||Number
1398575|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||mm||Standard Deviation|Mean
1398643|NCT01276327|Secondary|Tmax for Pioglitazone|Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||hours||Full Range|Median
1398576|NCT01276639|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 16, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398577|NCT01276639|Secondary|Joint Pain Assessment (JPA) Score|The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to “select the number that best describes any joint pain that participant may have experienced over the past 24 hours” with response options ranging from “0-no joint pain” to “10-worst possible joint pain.”|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398578|NCT01276639|Secondary|Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response|"The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from very dissatisfied to very satisfied with the study treatment."|Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants|||Number
1398579|NCT01276639|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) Scale Response|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants|||Number
1398580|NCT01276639|Secondary|Work Limitation Questionnaire (WLQ) Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398581|NCT01276639|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|HADS: 14-item questionnaire that screens for the presence of anxiety and depression symptoms. There are 7 items comprising the anxiety subscale, and 7 items comprising the depression subscale. Each item has response option ranging from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranges from 0 to 21 for each subscale; higher score indicates greater severity of anxiety or depression symptoms.|Baseline, Week 4, 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398582|NCT01276639|Secondary|36-Item Short-Form Health Survey Version 2, Acute (SF-36)|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 16, 28, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398583|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1398584|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398586|NCT01276639|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398587|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1398588|NCT01276639|Secondary|Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.|Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1398589|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
1398590|NCT01276639|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||nails||Standard Deviation|Mean
1398591|NCT01276639|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398614|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 4|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
1398592|NCT01276639|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 8, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398593|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1398594|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI 90 response up to Week 52 is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1398595|NCT01276639|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI 50 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1398596|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
1398597|NCT01276639|Secondary|Total Body Surface Area (BSA) With Psoriasis|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of BSA||Standard Deviation|Mean
1399222|NCT01270620|Primary|Assessment of Delirium|The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).|48 hours||||participants|||Number
1398598|NCT01276639|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
1398599|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of body surface area (BSA)” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398600|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores|The PASI quantifies the severity of a participant's psoriasis based on both, “lesion severity” and the “percent of BSA” affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398601|NCT01276639|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1398602|NCT01276639|Secondary|Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1398603|NCT01276639|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1398615|NCT01276639|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Week 4, 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1398604|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS. Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values. Here ‘n’ signifies those participants who were evaluable for this measure at specified time point for each arm, respectively.|||percentage of participants|||Number
1398605|NCT01276639|Secondary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|FAS: all randomized participants who received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Analysis population for “Placebo, CP-690,550” groups included FAS participants who were re-randomized at Week 16 to receive CP-690,550 5 mg or 10 mg. NRI method was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1398606|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
1398607|NCT01276639|Secondary|Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
1398608|NCT01276639|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Baseline up to Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||weeks||95% Confidence Interval|Median
1398616|NCT01276639|Secondary|Dermatology Life Quality Index (DLQI) Total Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1398669|NCT01276288|Secondary|Maximum Measured Concentration of HCT in Plasma (Cmax, ss)|Maximum measured concentration of HCT in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1398609|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response = at least 90% reduction in PASI relative to Baseline. Maintenance of PASI 90 response at Week 52 among participants achieving PASI 90 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 90 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
1398610|NCT01276639|Secondary|Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52|The PASI quantifies severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response = at least 75% reduction in PASI relative to Baseline. Maintenance of PASI 75 response at Week 52 among participants achieving PASI 75 response at Week 16 is reported. Percent probability and 95% CI were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PASI 75 response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
1398611|NCT01276639|Secondary|Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported. Percent probability and 95% confidence interval (CI) were estimated based on the product limit estimator in survival analyses. Event is loss of response. Probability of maintaining response is (1-probability of loss of response).|Week 52|FAS participants who had PGA response at Week 16. Data was not analyzed for participants initially randomized to placebo arm as they were re-randomized to active treatment group at Week 16 and thus maintaining response at Week 52 was not relevant. 'N' (number of participants analyzed) = participants with non-missing post-baseline response data.|||percent probability of response||95% Confidence Interval|Number
1398612|NCT01276639|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure.|||percent change||Standard Error|Least Squares Mean
1398613|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline.|Week 4|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
1398627|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1399223|NCT01270581|Primary|Duration of Respiratory Support|Data not collected due to insufficient enrollment for any data analysis.|average of 7 days|||||||
1398617|NCT01276639|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16|The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
1398618|NCT01276639|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
1398619|NCT01276639|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline."|Week 16|FAS included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
1398620|NCT01276639|Primary|Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of ‘Clear’ or ‘Almost Clear’ at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Full analysis set (FAS) included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550 or placebo). Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
1398621|NCT01276535|Secondary|Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks|The number of open comedones and closed comedones are summed to attain the total non-inflammatory lesion count.|Baseline and 6 weeks||||lesions||Standard Deviation|Mean
1398622|NCT01276535|Secondary|Change From Baseline in Inflammatory Lesion Count at 6 Weeks|The number of pustules, papules and nodules are summed to attain a total inflammatory lesion count.|Baseline and 6 weeks||||lesions||Standard Deviation|Mean
1398623|NCT01276535|Primary|Grade on the Burton et al. Acne Severity Grade Scale|The Burton et al. Acne Severity Grade Scale grades the type of acne lesion from Grade 0: no acne lesions through Grade 1: sub-clinical acne, Grade 2: mild acne, Grade 3: moderate acne; Grade 4: severe acne, to Grade 5: extremely severe acne. The number of participants whose entire face demonstrated an improvement of one or more grades on the Burton et al. Acne Severity Scale at week 6 relative to baseline was calculated.|baseline and 6 weeks||||participants|||Number
1398624|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
1398625|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||Day||Standard Deviation|Mean
1398626|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||Hours||Full Range|Median
1398628|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)|Day 1, 14, and 28|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||µg•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1398629|NCT01276509|Secondary|The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)|The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.|Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252|All participants who received at least 1 dose of investigational product and had data for at least 1 PK concentration were included in the PK concentration analysis.|||µg•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1398630|NCT01276509|Secondary|Immunogenicity Assessment of Anti-drug Antibodies (ADAs)|Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659|Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36|The safety analysis set included all participants who receive at least 1 dose of PF-00547659. Participants in placebo arm were not included in this analysis.|||events|||Number
1398631|NCT01276509|Secondary|Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer|Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.|Week 2, 4, 6, 8, 10 and 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants||90% Confidence Interval|Number
1398632|NCT01276509|Secondary|Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time|Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.|Week 2, 4, 6, 8, 10 and 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants||90% Confidence Interval|Number
1398633|NCT01276509|Secondary|Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission|Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).|Weeks 8 and week 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants|||Number
1398634|NCT01276509|Secondary|Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo|Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.|Week 0-12|The safety analysis set included all participants who received at least 1 dose of study medication.|||events|||Number
1398635|NCT01276509|Secondary|Safety and Tolerability of PF‑00547659 Dose Levels Versus Placebo|Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.|Week 0-12|The safety analysis set included all participants who received at least 1 dose of study medication.|||Number of participants|||Number
1398636|NCT01276509|Primary|Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate|Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.|Week 8 and week 12|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of Participants|||Number
1398637|NCT01276457|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths|Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.|||Partcipants|||Number
1398638|NCT01276457|Secondary|Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft|A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.|Baseline to end of study (Month 24)|Safety population: All randomized subjects who took at least one dose of study drug.|||Participants|||Number
1398639|NCT01276457|Primary|Renal Function Assessed by Creatinine Clearance|Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.|Month 12, Month 18, and Month 24|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.|||mL/min||Standard Deviation|Mean
1398640|NCT01276457|Primary|Number of Participants With Biopsy-proven Acute Rejection|A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.|Baseline to end of study (Month 24)|Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.|||Participants|||Number
1398641|NCT01276353|Primary|Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3||Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set: the group of subjects who had received at least one quantifiable E2020 concentration in plasma|||ng/mL||Standard Deviation|Mean
1398642|NCT01276353|Secondary|Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status|All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i|Visit 2 [Day1] and Visit 3 [Day 15]|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
1398644|NCT01276327|Secondary|Tmax for Linagliptin|Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||hours||Full Range|Median
1398645|NCT01276327|Secondary|AUC0-∞ of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1398646|NCT01276327|Secondary|AUC0-∞ of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1398647|NCT01276327|Secondary|AUC0-tz for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1398648|NCT01276327|Primary|Cmax of Pioglitazone|Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1398649|NCT01276327|Primary|AUC0-tz of Pioglitazone|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1398650|NCT01276327|Primary|Cmax of Linagliptin|Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1398651|NCT01276327|Primary|AUC0-72 of Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours|0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)|PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1398652|NCT01276314|Primary|Skin Healing Time|Healing was defined as complete re-epithelialization (i.e., the complete absence of erosions). We recorded the time taken by the skin to heal.|One to two months for SJS/TEN cases, and one to six months for DRESS cases.|We determined if the enrolled participants had SJS/TEN and DRESS using the criteria and histopathological examinations.|||days||Full Range|Median
1398653|NCT01276301|Secondary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory , bad and not assessable.|Within Day 15 to Day 25|Treated set|||percentage of participants|||Number
1398654|NCT01276301|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, Blood Chemistry and Electrocardiogram (ECG).|Clinically relevant abnormalities for physical examination, vital signs , blood chemistry and Electrocardiogram (ECG). New or abnormal findings were reported as adverse events.|Day1 to Day 11|Treated set (TS) included all subjects who had taken at least one dose of trial medication.|||participants|||Number
1398655|NCT01276301|Other Pre-specified|Verapamil Plasma Concentration|"Verapamil plasma concentration were measured in order to confirm exposure.~Note: No descriptive statistics was calculated for predose, 49.0 (h) and 73.0 (h), as most of the values were below the limit of quantification (BLQ)."|Predose and 1 hour (h), 25h, 49h and 73h after verapamil administration|Treated set (TS) included all subjects who had taken at least one dose of trial medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1398656|NCT01276301|Secondary|Apparent Volume of Distribution Following an Extravascular Dose (Vz/F)|"Apparent volume of distribution during the terminal phase following an extravascular dose.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation|||L||Geometric Coefficient of Variation|Geometric Mean
1398704|NCT01275664|Secondary|Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0|Adverse events at least possibly related to treatment|Up to day 6|All eligible and evaluable subjects|||Participants|||Count of Participants
1398705|NCT01275664|Secondary|Change in Vomiting, Nausea and Total FLIE Scores||Baseline to day 6|Data was not collected. Funding withdrawn.||||||
1398657|NCT01276301|Secondary|Apparent Clearance in Plasma After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in plasma after extravascular administration.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1398658|NCT01276301|Secondary|Mean Residence Time in the Body After Administration (MRTpo)|"Mean residence time of empagliflozin (empa) in the body after oral administration.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1398659|NCT01276301|Secondary|Terminal Half-life in Plasma (t1/2)|"Terminal half-life of empagliflozin in plasma.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1398660|NCT01276301|Secondary|Terminal Elimination Rate Constant (λz)|"Terminal elimination rate constant in plasma.~Note: The numbers provide below for standard deviation are of Coefficient of Variation."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1398661|NCT01276301|Secondary|Time From 0 to Maximum Plasma Concentration (Tmax)|Time from last dosing to the maximum plasma concentration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
1398662|NCT01276301|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to time of last quantifiable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1398663|NCT01276301|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of empagliflozin (empa) in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol||Geometric Coefficient of Variation|Geometric Mean
1398664|NCT01276301|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who had taken at least one dose of trial medication, who had provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1398665|NCT01276288|Secondary|Number of Subjects With Clinical Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests, 12-lead Resting Electrocardiogram (ECG), Physical Examination and Assessment of Tolerability by the Investigator|"Number of subjects with clinical relevant abnormalities in vital signs (blood pressure, pulse rate), 12-lead resting electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis, and monitoring of fasting plasma glucose), physical examination and assessment of tolerability by the investigator.~New abnormal findings were reported as Adverse Events (AE). Only Alanine aminotransferase normal under system organ class investigations was determined as an existing AE."|From first drug administration until up to 14 days after the last drug administration, up to 35 days|Treated set|||participants|||Number
1398666|NCT01276288|Primary|Urinary Sodium Excretion Over 24-hour run-in Periods|Urinary sodium excretion over 24-hour run-in periods to assess the harmonisation of electrolytes after intake of a standardised diet|Day 3, 2 and 1 before the first drug administration|PD analysis set completers|||mmol/day||Standard Error|Mean
1398667|NCT01276288|Secondary|Maximum Measured Concentration of TOR in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1398668|NCT01276288|Secondary|Area Under the Concentration-time Curve of TOR in Plasma (AUCτ,ss)|Area under the concentration-time curve of TOR in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with TOR alone and on Day 9 with EMPA plus TOR. The Pre-dose values were averaged over Days 1 to 3 with TOR alone and on Days 7 & 8 with EMPA plus TOR|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1399224|NCT01270555|Secondary|Beck Depression Inventory (BDI)|minimum score (least severe depression) = 0, maximum score (most severe) = 63|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
1398670|NCT01276288|Secondary|Area Under the Concentration-time Curve of HCT in Plasma (AUCτ,ss)|Area under the concentration-time curve of HCT in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 4 with HCT alone and on Day 9 with EMPA plus HCT. The Pre-dose values were averaged over Days 1 to 3 with HCT alone and on Days 7 & 8 with EMPA plus HCT|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1398671|NCT01276288|Secondary|Maximum Measured Concentration of Empa in Plasma (Cmax, ss)|Maximum measured concentration of Empa in plasma (Cmax, ss) at steady state|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1398672|NCT01276288|Secondary|Area Under the Concentration-time Curve of Empa in Plasma (AUCτ,ss)|Area under the concentration-time curve of Empa in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 post-dose on Day 5 with EMPA alone and on Day 9 with EMPA plus diuretic. The Pre-dose values were averaged over Days 1 to 4 with EMPA alone and on Days 7 & 8 with EMPA plus diuretic|Pharmacokinetic (PK) set, including all patients of the treated set who provide at least one observation for at least one secondary PK endpoint of AUC τ,ss or C max,ss for any analyte under any treatment without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1398673|NCT01276288|Primary|The Change in Total Muscle Sympathetic Nerve Activity (MSNA) From Off- Treatment|The change in total Muscle sympathetic nerve activity (MSNA) that represents an area under the curve of all C-fiber action potentials per minute. This endpoint was evaluated only for Empa. For this endpoint a baseline value was not defined. However, the parameters obtained at 2 measurements time points during the trial were compared.|One day before the drug administration, then day 4 after the first drug administration|PD analysis set completers|||action potentials per min||Standard Error|Mean
1398674|NCT01276288|Primary|The Change in Micturition Frequency From the Baseline|For this endpoint the change in total micturition frequency from the baseline was only examined for EMPA where baseline was defined as the day before the first drug administration.|Baseline and day 5|PD analysis set completers|||voids per day||Standard Error|Mean
1398675|NCT01276288|Primary|Change in Urinary Weight From Baseline|"Change from baseline in urinary weight in a 24 hour (h)- collection period, where baseline is the last 24-h collection period before first trial drug administration in each treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||g/day||Standard Error|Mean
1398676|NCT01276288|Primary|Change in Body Weight From Baseline|"Change in body weight from baseline , where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||kg||Standard Error|Mean
1398677|NCT01276288|Primary|Change in pH in Capillary or Arterialised Blood From Baseline|"Change in pH in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||pH||Standard Error|Mean
1398678|NCT01276288|Primary|Changes in Bicarbonate Concentrations of Calcium, Bicarbonate Ions and Base Excess in Capillary or Arterialised Blood From Baseline|"Changes in bicarbonate concentrations of calcium, bicarbonate ions and base excess in capillary or arterialised blood from baseline, where baseline was defined as the last measurement before trial drug administration of each treatment period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/ L||Standard Error|Mean
1398679|NCT01276288|Primary|Change in Urine Osmolality From Baseline|"Change in urine osmolality from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mOsm/kg||Standard Error|Mean
1398680|NCT01276288|Primary|Change in Urine pH From Baseline|"Change in urine pH from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||pH||Standard Error|Mean
1399225|NCT01270555|Secondary|Hamilton Depression Scale (HAM-D)|minimum score (least severe depression) = 0, maximum score (most severe) = 84|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
1398681|NCT01276288|Primary|Change in Urea Concentration in Urine|"Change in urea concentration in urine from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/L||Standard Error|Mean
1398682|NCT01276288|Primary|Change in Serum Concentration of Fibroblast Growth Factor-23 (FGF- 23) From Baseline|"Change in serum concentration of fibroblast growth factor-23 (FGF- 23) from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline, The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||RU/mL||Standard Error|Mean
1398683|NCT01276288|Primary|Change in Serum Concentration of Aldosterone From Baseline|"Change in serum concentration of Aldosterone from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||nmol/L||Standard Error|Mean
1398684|NCT01276288|Primary|Change in Serum Concentration of Renin, Intact Parathyroid Hormone (iPTH) and 1,25-dihydroxyvitamin D From Baseline|"Change in serum concentration of Renin, intact parathyroid hormone (iPTH) and 1,25-dihydroxyvitamin D from baseline , where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||pg/mL||Standard Error|Mean
1398685|NCT01276288|Primary|Change in Serum Concentration of Alkaline Phosphatase (ALP) From Baseline|"Change in serum concentration of ALP from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||U/L||Standard Error|Mean
1398686|NCT01276288|Primary|Change in Serum Concentration of Creatinine and Uric Acid From Baseline|"Change in serum concentration of Creatinine and Uric acid from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||umol/L||Standard Error|Mean
1398687|NCT01276288|Primary|Change in Serum Concentration of Sodium, Potassium, Magnesium, Calcium, Chloride, Phosphate, Glucose and Urea From Baseline|"Change in serum concentration of sodium, potassium, magnesium, calcium, chloride, phosphate, glucose and urea from baseline, where baseline was defined as the measurement obtained before first drug administration in the first period~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/L||Standard Error|Mean
1398688|NCT01276288|Primary|Change in Serum Osmolality From Baseline|"Changes in serum osmolality from baseline based on a blood sample.~Baseline was defined as the measurement obtained before the first drug administration in the first period.~The mean change from baseline was evaluated as:~Empa: day 6- baseline, HCT: day 5-baseline, TOR: day 5-baseline, Empa+ HCT: day 10- baseline, Empa+ TOR: day 10- baseline,~The mean for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|baseline and then day 6 for Empa, day 5 for TOR and HCT, day 10 for Empa+TOR and Empa+HCT|PD analysis set completers|||mOsm/Kg||Standard Error|Mean
1398689|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of N-terminal Telopeptide (NTx) From Baseline|"Change in urinary excretion in a 24-hour period of N-terminal telopeptide (NTx) from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||nM BCE/ mMC||Standard Error|Mean
1398706|NCT01275664|Primary|Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)|Number of participants who had complete control defined by no vomiting|During the 6 days following chemotherapy||||Participants|||Count of Participants
1398690|NCT01276288|Primary|Change in Urinary Excretion in a 24-hour Period of Sodium, Potassium, Magnesium, Chloride, Calcium, Phosphate, Creatinine, Uric Acid, Glucose From Baseline|"Change in urinary excretion in a 24-hour period of sodium, potassium, magnesium, chloride, calcium, phosphate, creatinine, uric acid, glucose from baseline, where baseline was defined as the value obtained from the last 24-hour (h) collection period before the first drug administration in the first treatment period. This applies also to sodium excretion in urine, which is additionally obtained one day before the drug administration before the second period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|PD analysis set completers|||mmol/day||Standard Error|Mean
1398691|NCT01276288|Primary|Change in Clearance of Sodium, Potassium, Creatinine, Magnesium, Chloride,Calcium, Phosphate and Uric Acid From Baseline|"Change in clearance of sodium, potassium, creatinine, magnesium, chloride,calcium, phosphate and uric acid from baseline, where baseline is defined as the value obtained from the last 24-h collection period before the first drug administration in the first treatment period.~The mean change from baseline was evaluated as:~Empa: day 5- baseline, HCT: day 4-baseline, TOR: day 4-baseline, Empa+ HCT: day 9- baseline, Empa+ TOR: day 9- baseline,~The means for the Empa arm represent combined adjusted means of all four sequences that is Empa administered before or after the administration of either TOR, HCT and their combination with Empa"|24 hour sampling interval at baseline and then day 5 for Empa, day 4 for TOR and HCT, day 9 for Empa+TOR and Empa+HCT|Pharmacodynamic (PD) analysis set completers includes all evaluable patients of the treated set who provide a baseline and at least one on-treatment observation for at least one primary (PD) endpoint under any treatment without important protocol violations relevant to the evaluation of PD and who continued the trial as planned|||ml/min||Standard Error|Mean
1398692|NCT01276223|Primary|Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks|A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).|Baseline, up to 4 weeks|All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.|||units on a scale||Standard Deviation|Mean
1398693|NCT01276197|Primary|Diastolic BP Measurement at Follow-up|Participants BP measurement at 6-month follow-up|6-month following intervention||||mmHg||Standard Deviation|Mean
1398694|NCT01276197|Primary|Systolic BP at Follow-up|Systolic Bp measurement at 6-month follow-up; we modeled the impact of Intervention assignment on SBP, adjusting for Baseline. Thus, baseline SBP was collected but not used as outcome; Baseline SBP us used as a covariate.|6 months after intervention|Our analyses was completed with those who completed follow-up visit and varies from participant flow as we are not able to include those lost to follow-up.|||mmHg||Standard Deviation|Mean
1398695|NCT01276171|Secondary|Total Success Rate||5 min|chi-squre test|||Participants|||Count of Participants
1398696|NCT01276171|Secondary|Time to Successful Cannulation||5 minutes||||min||Inter-Quartile Range|Median
1398697|NCT01276171|Primary|First Attempt Success Rate With 3 Different Technique|The primary objective of this study is to compare the first attempt success rate for radial artery cannulation between the palpation, Doppler and U/S guided technique when applied by anesthesia trainees. Secondary outcomes include: success rate within 5 minutes, time to successful cannulation compared with three different techniques.|5 minutes||||participants|||Number
1398698|NCT01276106|Primary|Change in HbA1c From Baseline|For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p<0.05.|24 weeks|The Full Analysis Set included all randomized patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline HbA1c assessment.|||percentage points||Standard Error|Least Squares Mean
1398699|NCT01276054|Primary|Whether or Not a Patient Has Developed Grade 1+ LE|LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.|During the first year post-operatively|Unable to analyze due to early termination of the study||||||
1398700|NCT01275833|Primary|Range Finding of Functional and Hemodynamic Changes Using Echocardiographic Determined Measures.|Echocardiographic measures will include, but not be limited to, left ventricular volumes, left ventricular diameters, and ejection fraction.|6 months|The study was terminated early: long PR intervals are relatively rare in this population, and it would take an inordinately long time to enroll sufficient patients. Because of the early termination of the study, no data was analyzed since the primary objective is underpowered.||||||
1398701|NCT01275755|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Treatment Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.|||Number of SBMs/week||Standard Error|Mean
1398702|NCT01275664|Secondary|Percentages of Patients With NIDL Based on FLIE||Up to day 6|Data not collected. Funding withdrawn.||||||
1398703|NCT01275664|Secondary|Mean and Standard Deviation of Vomiting, Nausea, and Total FLIE Scores||Baseline|Data not collected. Funding withdrawn||||||
1398707|NCT01275625|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.|Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.|||Participants|||Number
1398708|NCT01275625|Secondary|Number of Participants With Genotypic Resistance.|The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.|Screening to Week 48 or Time of treatment Failure|All participants who discontinued therapy early or who reached Week 48 with sufficient plasma HIV 1 RNA for analysis (500 copies/mL) were included in the analysis.|||Participants|||Number
1398709|NCT01275625|Secondary|Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Ratio||Standard Deviation|Mean
1398710|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percent||Standard Deviation|Mean
1398711|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||cells/mcL||Standard Deviation|Mean
1398712|NCT01275625|Secondary|Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percent||Standard Deviation|Mean
1398713|NCT01275625|Secondary|Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)|Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count|Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||cells/microliter (cells/mcL)||Standard Deviation|Mean
1398714|NCT01275625|Secondary|Virologic Response: Rate of Virologic Failure at Week 48.|Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.|48 weeks|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Participants|||Number
1398715|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.|Participants’ responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percentage of participants|||Number
1398716|NCT01275625|Secondary|Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.|Participants’ responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48|FAS Population included those participants who had taken at least 1 dose of the study drug.|||Percentage of participants|||Number
1398717|NCT01275625|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.|Participants’ responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.|48 weeks|Full Analysis Set (FAS) Population included those participants who had taken at least 1 dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1398718|NCT01275586|Primary|Disease Response|To estimate the disease control rate (PD,SD, PR, CR) with Tasigna® in patients with neurofibromas (NF1) using standard RECIST criteria. Complete Response (CR) is defined as; disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. Disease Progression (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|6 months||||Participants|||Count of Participants
1398719|NCT01275430|Secondary|Phase I: Amount of PICC Tip Movement When the Subject’s Arm is Adducted From a 90° Position to the Subject’s Side.|"Mean distance (mm) of PICC tip movement when the subject’s arm is adducted from a 90° position to the subject’s side, by directly measuring the distance from the catheter tips to the parts of the CAJ (upper, middle, and lower) with the subject's arm at 90°and compared to the PICC tip with the subject's arm at the side .~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||mm||Standard Deviation|Mean
1399226|NCT01270555|Secondary|Hamilton Anxiety Scale (HAM-A)|minimum score (least severe anxiety) = 0, maximum (most severe) = 56|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
1398720|NCT01275430|Secondary|Phase I: Change in Distance (mm) Between the Location of the Cavoatrial Junction When Angiographic CT is Performed With the Arms Above the Head vs at the Subject’s Side.|"Measurements (mm) of the location of the cavoatrial junction on Angiographic CT to evaluate shift greater than 5mm in mediastinal structures between ACT acquisitions obtained with the arms above the head vs arms at side of body (90°).~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||mm||Standard Deviation|Mean
1398721|NCT01275430|Secondary|Number of Participants With Acceptable Angiographic CT Visualization of the PICC Tip When Using Sherlock 3CG for PICC Placement|"Proportion of acceptable visualization of the PICC tip location when maximum p-wave amplitude is observed.~Note – this endpoint is to assess the diagnostic capability of Angiographic Computed Tomography (ACT). It is not designed to reflect on PICC tip location.~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||participants|||Number
1398722|NCT01275430|Secondary|Phase I: Distance Necessary for Repositioning of the PICC Tip Upon Observation of the Maximum P-wave Amplitude, if Necessary.|"Distance (mm), if any, that is required to move the PICC tip upon observation of the maximum p-wave amplitude in order to have the PICC tip at the upper cavoatrial junction. Direct measurement of distance from the catheter tips to the parts of the CAJ~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Day 0||||mm||Standard Deviation|Mean
1398723|NCT01275430|Primary|Phase I - Location of the PICC Tip Upon Observation of Maximum P-wave Amplitude Using Sherlock 3CG.|"Mean distance (mm) from the PICC tip to the upper cavoatrial junction (CAJ) upon observation of maximum p-wave amplitude when using Sherlock 3CG.~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."|Time of PICC placement (Day 0)||||mm||Standard Deviation|Mean
1398724|NCT01275365|Secondary|Change of Derogatis Affective Balance Scale (DABS)|The Derogatis Affects Balance Scale (DABS) is a multidimensional self-report mood and affects inventory comprised of 40 adjective-items using a 5-point Likert style scale. The DABS global scores consist of the Positive Total score (PTOT), Negative Total score (NTOT), where The Positive Affects Total (PTOT) is defined as the sum of all scores on the four positive affects dimensions of joy, contentment, vigor and affection, ranging 0-80. Similarly, the Negative Affects Total (NTOT) is represented as the sum of scores on the four negative dimensions of anxiety, depression, guilt and hostility, ranging 0-80. The Affects Expressiveness Index (AEI) is defined as the sum total of PTOT and NTOT, ranging 0-160. Higher score yields stronger affective intensity.|6 months from baseline||||units on a scale||Standard Error|Mean
1398725|NCT01275365|Secondary|Change of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale|The FACIT Fatigue Scale is a 13-item questionnaire that measures an individual’s level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point scale (4 = not at all fatigued to 0 = very much fatigued). Score ranges 0-52. The higher the score, the better the quality of life.|6 months from baseline||||units on a scale||Standard Error|Mean
1398726|NCT01275365|Secondary|Change of Psychological Well Being Index (PGWBI)|The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The 22 items are grouped in 6 dimensions. A global score is computed as the sum of all items with range of 0-110. A higher score yields better performance.|6 months from baseline||||units on a scale||Standard Error|Mean
1398727|NCT01275365|Secondary|Change of Self-reported Physical Function Domain of Short Form Health Survey (SF-36)|36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Physical function domain of the Medical Outcomes Study Short Form-36 (SF-36) contains 10 items with the score range of 0-100. Higher score yields better performance.|6 months from baseline||||units on a scale||Standard Error|Mean
1398728|NCT01275365|Secondary|Change of 50-meter Loaded Walking Test|Tests of Physical Function and Task-Specific Performance measured by 50-meter timed walk + 20% load carry.|6 months from baseline||||meters per second||Standard Error|Mean
1398729|NCT01275365|Secondary|Change of Stair Climbing Tests|Tests of Physical Function and Task-Specific Performance measured by Stair-climbing power +/- 20% load carry.|6 months from baseline||||watts||Standard Error|Mean
1398730|NCT01275365|Secondary|Change of 6-minute Walking Distance|Tests of Physical Function and Task-Specific Performance measured by 6-min walking distance|6 months from baseline||||meters||Standard Error|Mean
1398731|NCT01275365|Secondary|Change of Leg Press Power|Muscle Performance measured using Power of hip and knee extension by Bassey's leg rig.|6 months from baseline||||watts||Standard Error|Mean
1398732|NCT01275365|Secondary|Change of Maximal Voluntary Strength|Tests of Muscle Performance: (1) Maximal voluntary strength measured by 1-repetition maximum method in leg press; (2) Maximal voluntary strength in chest press; this exercise was chosen because it involves the large muscle groups of the upper extremities.|6 months from baseline||||newton||Standard Error|Mean
1398733|NCT01275365|Primary|Change in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DXA)|Primary outcome is change in lean body mass, measured by dual energy X-ray absorptiometry (DXA)|6 months from baseline||||kg||Standard Error|Mean
1398734|NCT01275313|Primary|Incidence of a Sitting-induced Pressure Ulcer|Skin assessments for incidence of sitting-induced pressure ulcer will occur once per week until occurrence of a pressure ulcer or 180 days|182 days||||Participants|||Count of Participants
1398735|NCT01275196|Secondary|Summary Statistics of Trough Imatinib and Major Metabolite CGP74588 of Imatinib and Nilotinib PK Concentration by Time Point|Pharmacokinetic Analysis Set|12 Months|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
1398736|NCT01275196|Secondary|Actual Dose Intensity|Total dose/time on treatment (periods of zero dose were included).|End of Study (up to 40 months)|Safety set consisted of all randomized patients who received at least one dose of study medication.|||mg/day||Standard Deviation|Mean
1398771|NCT01275066|Primary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.|||meters||Standard Deviation|Mean
1398737|NCT01275196|Secondary|Modified ELN2009 Criteria|Patients satisfying criteria for several “modified ELN 2009” categories are presented once under the worst category (Optimal> Suboptimal > Treatment failure). Patients in the “Discontinued” category are those who discontinued before the time point considered without satisfying any of the ELN 2009 criteria. Patients in the “Missing” category are those ongoing in the trial at the time point considered but with only missing or non evaluable data for ELN 2009 criteria.|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants|||Number
1398738|NCT01275196|Secondary|Best Complete Hematologic Response (CHR)|CHR was defined as having all of the following criteria present at any assessment, which was confirmed by another assessment at least after 4 weeks: • WBC count < 10 x 10E9 /L • Platelet count < 450 x 10E9 /L • Basophils < 5% • No blasts and promyelocytes in peripheral blood • Myelocytes + metamyelocytes < 5 % in peripheral blood • No evidence of extramedullary involvement. The assessment was not considered CHR, if there were any values indicative of CML in AP or BC (i.e. by blasts in bone marrow). For confirmation of CHR, both the initial CHR as well as the confirming assessment (at least 4 weeks after the initial assessment) had to satisfy all criteria mentioned above, without any assessment in between which indicated ‘No response’.|Months 1, 3, 4, 5, 6, 9,12, 15,18, 21, 24, 30, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of participants||95% Confidence Interval|Number
1398739|NCT01275196|Secondary|Kaplan-Meier Estimates of Overall Survival (OS) on Treatment|Patients who discontinued study treatment early or completed the study protocol and did not enter into the extension protocol were to be followed for survival every 3 months for up to 2 calendar years from the date the last patient randomized received the first dose of study drug and every 6 months until Last Patient Last Visit. Overall survival (all deaths) was defined as the time between date of randomization and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment, i.e. overall survival on-study. The time was censored at the date of last assessment in the study for patients who are still being treated and at the date of last contact for patients who discontinued treatment.|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
1398740|NCT01275196|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS) on Treatment|"Progression-free survival was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of death from any cause, whichever is earlier. This variable was analyzed in 2 ways:~On-treatment: included progressions to AP/BC or deaths occurring only on-treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease or cytogenetic evaluation) in the study before the cut-off date of the analysis for patients without event.~On-study: included progressions to AP/BC or deaths occurring in the study or during the follow-up period after discontinuation of study treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment."|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
1398741|NCT01275196|Secondary|Kaplan-Meier Estimates of Event-free Survival (EFS) on Treatment|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following:-Death due to any cause, - Progression to AP or BC, Loss of partial cytogenetic response (PCyR), - Loss of CCyR, - Loss of CHR|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
1398742|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to Progression to Accelerated Phase/Blast Crisis (AP/BC) on Treatment|"Time to progression to AP/BC was defined as the time from the date of randomization to the date of event defined as the first disease progression to AP/BC or the date of CML-related death, whichever is earlier. This variable was analyzed in 2 ways:~On-treatment: included progressions to AP/BC or CML-related deaths occurring on treatment in the study as events. The time was censored at the date of last on-treatment assessment (hematology, extramedullary disease, or cytogenetic evaluation) in the study for patients without event.~On-study: included progressions to AP/BC or CML-related deaths occurring in the study or during the follow-up period after discontinuation of treatment as events. The time was censored at the last assessment date in the study for patients who were still being treated and at the date of last contact for patients who discontinued treatment"|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization|||Months||95% Confidence Interval|Median
1398743|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First CCyR Among Patients Who Achieved CCyR|Duration of CCyR (months) = (date of CCyR loss or censoring-date of first CCyR + 1)/30.4375|End of Study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization|||Months||95% Confidence Interval|Median
1398744|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First CCYR|Time to first CCyR (months) = (date of first CCyR – date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||months||95% Confidence Interval|Median
1398806|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398745|NCT01275196|Secondary|Best Complete Cytogenic Response (CCyR) Rate by Each Time Point|CCyR is defined as 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.|Months 6, 12, 18, 30, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
1398746|NCT01275196|Secondary|Kaplan-Meier Estimates of Duration of First MMR Among Patients Who Achieved MMR|Duration of first MMR (months) = (date of loss of MMR or censoring-date of first MMR + 1)/30.4375.|End of Study (Up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
1398747|NCT01275196|Secondary|Durable MMR Rate at 24 Months|The rate of durable MMR at 24 months, defined as the proportion of patients who have achieved MMR at 12 months, and also maintain continuous MMR until the 24 month time point (1 month = 28 days) without intervening loss of MMR in between 12 and 24 months|24 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Perentage of Participants||95% Confidence Interval|Number
1398748|NCT01275196|Secondary|Kaplan-Meier Estimates of Time to First MMR|Time to first MMR (months) = (date of first MMR or censoring – date of randomization + 1) / 30.4375.|End of study (up to 40 months)|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||months||95% Confidence Interval|Median
1398749|NCT01275196|Secondary|Best MMR by Each Timepoint|Best MMR rates by scheduled time point are cumulative response rates up to that time point. In this analysis, patients who had achieved MMR at or before the time point were counted as responders, no matter if they lost the response/discontinued or not. Therefore, this response rate represented the best observed response rate up to that specific time point.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
1398750|NCT01275196|Secondary|MMR Rate at Each Time Point|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as ‘responders’ and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as ‘non-responders’. These time points including the 12 month data were calculated based on the final analysis after the end of the study.|Months 3,6,9,12,15, 18, 21, 24, 36|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
1398751|NCT01275196|Primary|Major Molecular Response (MMR) at 12 Months - With Imputation.|Major molecular response (MMR) was defined as a value of ≤ 0.1% of BCR-ABL ratio on the IS. The minimum number of control genes for a sample to be valid was 3000. For statistical comparison purpose, MMR was considered as a binary variable with patients achieving MMR grouped as ‘responders’ and patients not achieving MMR, patients with missing PCR evaluations or patients with atypical transcripts at baseline grouped as ‘non-responders’. This endpoint was calculated based on the 12 month analysis.|12 months|Patients in the FAS consisted of all patients who were randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment group to which they were assigned at randomization.|||Percentage of Participants||95% Confidence Interval|Number
1398752|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 3. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.|||ratio||Standard Deviation|Mean
1398753|NCT01275131|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 1. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.|||Ratio||Standard Deviation|Mean
1398754|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) for Stage 3 studies is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.|||Picomoles*minutes/liter||Standard Deviation|Mean
1398755|NCT01275131|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1|Area under the glucose concentration curve for 0 to 360 minutes (AUC[0-360]) from Stage 1 is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.|||Picomoles*minutes/liter||Standard Deviation|Mean
1398807|NCT01274559|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398756|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 3|Time to 50% of total glucose infused (50%Gtot) is presented for Stage 3. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.|||Minutes||Standard Deviation|Mean
1398757|NCT01275131|Secondary|Time to 50% Total Glucose Infused (50%Gtot), Stage 1|Time to 50% total glucose infused (50%Gtot) is presented for Stage 1. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.|||Minutes||Standard Deviation|Mean
1398758|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3|Early and late time to 50% maximum glucose infusion rates (tGIR50%max) for Stage 3 studies are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable early and late tGIR50%max data.|||Minutes||Standard Deviation|Mean
1398759|NCT01275131|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1|Early and late times to 50% maximum glucose infusion rate (tGIR50%max) for Stage 1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable early or late tGIR50%max data.|||Minutes||Standard Deviation|Mean
1398760|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 3 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.|||Minutes||Standard Deviation|Mean
1398761|NCT01275131|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1|Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 1 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable tGIRmax data.|||Minutes||Standard Deviation|Mean
1398762|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 3|Maximum glucose infusion rates (GIRmax) for Stage 3 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable GIRmax data.|||Milligrams/kilogram/minute||Standard Deviation|Mean
1398763|NCT01275131|Primary|Early Exposure to Insulin (%AUC[0-60]), Stage 3|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10|Participants who completed all periods of study within a given stage with evaluable %AUC(0-60) data.|||Percentage of AUC(0-360)||Standard Deviation|Mean
1398764|NCT01275131|Secondary|Maximum Glucose Infusion Rate (GIRmax), Stage 1|Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0 up to 360 minutes postdose on Day 2/6 and Day 4/8|Participants who completed all periods of study within a given stage with evaluable GIRmax data.|||Milligrams/kilogram/minute||Standard Deviation|Mean
1398765|NCT01275131|Primary|Early Insulin Exposure (%AUC[0-60]), Stage 1|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.|10 minutes predose up to 60 minutes postdose|Participants who completed all study periods within a given stage with evaluable early insulin exposure (%AUC[0-60]) data.|||Percentage of AUC(0-360)||Standard Deviation|Mean
1398766|NCT01275092|Secondary|The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table|Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio.|1 day||||ratio||Inter-Quartile Range|Median
1398767|NCT01275092|Primary|Percentage of Patients With Device Technical Success|Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation.|1 day||||percentage of participants||95% Confidence Interval|Number
1398768|NCT01275092|Primary|Percentage of Participants With Clinical Procedural Success|Defined as <30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first.|48-hrs or hospital discharge, whichever occurs first||||percentage of participants||95% Confidence Interval|Number
1398769|NCT01275066|Secondary|Percent Change From Baseline in Urine Keratan Sulfate Normalized for Urine Creatinine||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Nine missing outcomes at Week 24 were imputed using method of multiple imputation.|||percent change||Standard Deviation|Mean
1398770|NCT01275066|Secondary|Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test||Baseline to Week 24|Intention to treat (all patients receiving at least one dose of study drug). Two missing outcomes at Week 24 were imputed using method of multiple imputation.|||stairs/minute||Standard Deviation|Mean
1398772|NCT01275053|Primary|Leptin Signaling|"Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration.~The primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration.~The p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration."|Baseline and 30 minutes|All subjects received biopsies before and 30 min after leptin administration.|||fold change||Full Range|Mean
1398773|NCT01274897|Secondary|Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination||during 7 days of vaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.|||Subjects|||Number
1398774|NCT01274897|Secondary|Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.|||Percentages of subjects||95% Confidence Interval|Number
1398775|NCT01274897|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).|day 1 and day 29|Analysis was done on PP population.|||Titers||95% Confidence Interval|Geometric Mean
1398776|NCT01274897|Primary|Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).~Seroresponse is defined as:~for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.~for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer."|day 29|Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points.|||Percentages of subjects||95% Confidence Interval|Number
1398777|NCT01274715|Primary|Change in Hemoglobin A1C|Value of Hemoglobin A1C reduction post-intervention. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|baseline, 3 months, and 6 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
1398778|NCT01274715|Primary|Change in PHQ-9 (Patient Health Questionnaire-9)Scores|The full name of the measure is the Patient Health Questionnaire-9. This is a self-reported measure of depressive symptoms. This is a nine item measure with a response for each item between 0-3. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. The coaching sessions take place over approximately 3 months -- outcomes are measured at baseline, 3 months and again at 6 months. Change from baseline to 3 months was calculated. Then change from baseline to 6 months was calculated.|Baseline, 3 months, and 6 months||||scores on a scale||Standard Deviation|Mean
1398779|NCT01274637|Secondary|Heparin Induced Thrombocytopenia|All subjects who develop thrombocytopenia (platelets less than 80 x 109/L and/or with >50% decrease from baseline) will be investigated for Heparin Induced Thrombocytopenia (HIT) by having ELISA and serotonin release assays to confirm or refute a diagnosis of HIT. HIT will be diagnosed with a positive PF4 (platelet factor 4) HIT ELISA assay.|From Randomization to Day 90||||Participants|||Count of Participants
1398780|NCT01274637|Secondary|Major Bleeding or Clinically Relevant Non-major Bleeding|"Major bleeding meets at least one of the following: Fatal bleeding; Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, retroperitoneal, etc.); Bleeding causing a fall in hemoglobin level of 20 g L−1 (1.24 mmol L−1) or more, or leading to transfusion of two or more units of whole blood or red cells .~Clinically Relevant Non-major Bleeding does not meet the criteria for major bleeding but meets at least one of the following: Hospitalization; Medical intervention; Unscheduled contact with a physician; Discomfort (pain, or impairment of activities of daily life)."|From Randomization to Day 90||||Participants|||Count of Participants
1398781|NCT01274637|Secondary|Death From Venous Thromboembolism|"If a subject dies between randomization and late postpartum follow up (Day 90 +/- 7 days) the death will be adjudicated as certain, highly probable, probable, or unlikely due to Pulmonary Embolism (PE) using the following criteria.~Certain: hypotension, hypoxia, cardiac arrest with no other explanation other than PE and autopsy or radiographic confirmation Highly probable: criteria for certain but another disease could have caused the death Probable: other cause suspected based on clinical evidence but 100% certainty not available Unlikely: all other cases."|From Randomization to Day 90||||Participants|||Count of Participants
1398782|NCT01274637|Secondary|Late Symptomatic Venous Thromboembolism|This includes symptomatic Deep Vein Thrombosis or Pulmonary Embolism. Suspected outcomes will be adjudicated by a blinded adjudication committee.|From Day 10 to Day 90||||Participants|||Count of Participants
1398783|NCT01274637|Secondary|Venous Thromboembolism in the Early Postpartum Period.|This includes symptomatic Deep Vein Thrombosis (DVT) or pulmonary embolism (PE) in the interval between randomization and the last dose of study drug (10 days +/- 3 days) OR asymptomatic proximal DVT detected by compression ultrasound of both legs done within 24hrs of the last dose of study drug (10 days (+/- 3 days) postpartum). Compressed and non-compressed images will be obtained from the calf trifurcation to the inguinal ligament. All suspected outcomes will be adjudicated by a blinded expert adjudication committee.|From randomization to Day 10||||Participants|||Count of Participants
1398784|NCT01274637|Primary|Feasibility of Recruitment and Trial Operations.|The average number of subjects that are recruited per site per month during a 4 month active recruitment phase at each site.|4 months||||participants per site per month|||Number
1398808|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398785|NCT01274611|Primary|Percentage Change of Sweat Rate (mg/Min) at Baseline Compared to 3 Months|"The primary outcome measure was the treatment associated unilateral axillary percentage change of sweat rate in milligrams per minute in the exercise-induced state measured at baseline compared with the sweat rate measured 3 months after treatment.~This process entails placing filter paper on the area of concern for a specific amount of time, after which the paper is weighed and sweat production is quantified in units of weight per time. The amount of sweat produced was recorded in milligrams per minute by subtracting the initial weight of the paper segment before exercise from the final, post-application weight, after exercise and dividing by 5 minutes.~Percentage sweat rate was calculated as [(sweat rate at baseline - sweat rate at 3 months)/sweat rate at baseline]*100 with a positive percent change indicating sweat rate reduction if the baseline had a higher sweat rate."|baseline and 3 months||||Percentage Change|Participants|Full Range|Mean
1398786|NCT01274611|Secondary|The Change in Hyperhidrosis Disease Severity Scores From Baseline Compared to 3 Months After Treatment|"Change in mean score on the Hyperhidrosis Disease Severity Scale (HDSS) from baseline minus 3 months after treatment.~The HDSS iquestionnaire assigns a point value to the patient’s view:~My sweating is...~never noticeable and never interferes with my daily activities~tolerable but sometimes interferes with my daily activities~barely tolerable and frequently interferes with my daily activities~intolerable and always interferes with my daily activities~Lower point values are considered better and higher point values are considered worse.~A larger change in score between baseline and 3 months is considered a better outcome and a smaller change in score is considered a worse outcome for each treatment. Change scores were calculated (baseline minus 3 months). Positive change scores indicate that scores were better; negative change scores indicate their scores were worse after treatment."|Baseline and 3 months||||Scores on a scale|Participants|Standard Deviation|Mean
1398787|NCT01274585|Secondary|Change in Fecal Incontinence Quality of Life (FIQoL) Score|The Fecal incontinence Quality of Life (FIQoL) score evaluates how fecal incontinence impacts the subjects quality of life. The scale ranges from 37 to 159 where the higher the score, the better the quality of life associated with symptoms.|12 weeks|Only 4 of the 5 subjects completed questionnaires at the completion of the trial. Therefore, these were the only subjects included in analysis.|||mean score||Full Range|Mean
1398788|NCT01274585|Secondary|Change in Fecal Incontinence Severity Index (FISI) Score|Fecal Incontinence Severity Index (FISI) is a tool used to stratify severity of fecal incontinence in the subjects. The range of score is from 0 to 61 where the higher score correlates with more severe symptoms of incontinence.|12 weeks|Only 4 of the 5 subjects completed questionnaires at the completion of the trial. Therefore, these were the only subjects included in analysis.|||mean score||Full Range|Mean
1398789|NCT01274585|Primary|Frequency of Fecal Incontinence|Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.|Diary kept for 14 days following treatment||||number of accidents||Full Range|Mean
1398790|NCT01274559|Secondary|Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment|assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines|Baseline and 12 weeks|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398791|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398792|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398793|NCT01274559|Secondary|Percent Change From Baseline in Lp(a) at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398794|NCT01274559|Secondary|Percent Change From Baseline in TC:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398795|NCT01274559|Secondary|Percent Change From Baseline in Apo B:Apo A-I at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398796|NCT01274559|Secondary|Percent Change From Baseline in Apo B at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398797|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398798|NCT01274559|Secondary|Percent Change From Baseline in TG at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398799|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398800|NCT01274559|Secondary|Percent Change From Baseline in LDL-C:HDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398801|NCT01274559|Secondary|Percent Change From Baseline in LDL-C at Week 4||Baseline and Week 4|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398802|NCT01274559|Secondary|Percent Change From Baseline in TC at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398803|NCT01274559|Secondary|Percent Change From Baseline in Apo A-I at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398804|NCT01274559|Secondary|Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398805|NCT01274559|Secondary|Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
1398813|NCT01274533|Secondary|Safety of Lenalidomide Monotherapy||28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.||||||
1398814|NCT01274533|Primary|Response Rate (CR + Cru + PR)|Peripheral blood, CT or MRI|28 days|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in Aug. 2013.||||||
1398815|NCT01274429|Secondary|Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.|Measure changes over the course of treatment in serum specific IgE and IgG4, skin prick tests, TH1 and TH2 cytokines, and CD4+ CD25+ FoxP3+ regulatory T cells|2-3 years|No subjects reached the end of study prior to closure of the study and therefore no end of treatment mechanistic data was collected in order to compare against the baseline.||||||
1398816|NCT01274429|Primary|Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.|Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance|2-3 years|No subjects reached the end of study food challenge prior to closure of the study and therefore no data was collected towards this endpoint.||||||
1398817|NCT01274182|Other Pre-specified|Number of Patients With at Least One Anti-Drug-Antibody (ADA) Positive Serum Sample|Number of patients with at least one post-baseline Anti-Drug-Antibody (ADA) positive serum sample until the last study visit. Sampling was at Day 1, 29, 113, 169, 267, 365, optional visit 1 (could be at any time between day 169 - week 24 and day 365 - week 52 for patients, who received a 2nd treatment course) and optional visit 2 (only applicable for patients, who received a 2nd treatment course, 26 weeks thereafter, if this was after day 365 - week 52).|through study completion, an average of 1 year|Patients with positive ADA results at randomization were excluded from analysis|||participants|||Number
1398818|NCT01274182|Secondary|Participant Response as Assessed by EULAR Response Criteria|"Present DAS28 ≤ 3.2 (low): good response (if improvement > 1.2), moderate response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).~Present DAS28 > 3.2 to ≤ 5.1 (moderate): moderate response (if improvement > 1.2), moderate response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6).~Present DAS28 > 5.1 (high): moderate response (if improvement > 1.2), no response (if improvement >0.6 and ≤ 1.2), no response (if improvement ≤ 0.6)."|At week 24|PP analysis set|||Participants|||Count of Participants
1398819|NCT01274182|Secondary|Summary of Disease Activity According to SDAI|"In order to calculate the Simplified Disease Activity Index (SDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient’s global assessment of disease activity and the physician’s global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst).~SDAI = CDAI + CRP (in mg/dL)~(CDAI = tender28 + swollen28 + patient’s global assessment (in cm) + physician’s global assessment (in cm))"|At week 24|PP analysis set|||Participants|||Count of Participants
1398820|NCT01274182|Secondary|Summary of Disease Activity According to CDAI|"In order to calculate the Clinical Disease Activity Index (CDAI) the number of tender and swollen joints were assessed using the 28 -joint count (tender28 and swollen28). The patient’s global assessment of disease activity and the physician’s global assessment of disease activity were measured using a Visual Analogue Scale (VAS) of 10 cm (from 0=best to 10=worst).~CDAI = tender28 + swollen28 + patient’s global assessment (in cm) + physician’s global assessment (in cm)"|At week 24|PP analysis set|||Participants|||Count of Participants
1398821|NCT01274182|Secondary|Number of Patients With ACR20 (CRP) Response|"A patient will be considered as improved according the ACR20 criteria~at least 20 % improvement from baseline in tender joint count, using the 68-joint count~at least 20 % improvement from baseline in swollen joint count, using the 66-joint count~and at least 20% improvement from baseline in a least 3 of the following 5 measures:~Patient’s assessment of RA pain (VAS 100 mm)~Patient’s global assessment of disease activity (VAS 100 mm)~Physician’s global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire disability index)~Acute phase reactant (C-reactive protein or erythrocyte sedimentation rate)"|24 weeks|PP analysis set|||Participants|||Count of Participants
1398822|NCT01274182|Secondary|Change From Baseline in DAS28(CRP) at Week 24|"Change from baseline in Disease Activity Score 28 joint count - C-reactive proteine DAS28(CRP) at Week 24.~In order to calculate the DAS28(CRP) the number of tender joints and swollen joints were assessed using 28-joint count (tender28 and swollen28).The patient’s global assessment of disease activity (GH) measured on a Visual Analogue Scale (VAS from 0mm - best to 100mm - worst) was obtained.~DAS28(CRP) = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GH + 0.96 The DAS28(CRP) provides a number on a scale from 0 to 10 indicating the current activity of the RA, while lower values correspond with less disease activity. A decrease in DAS28 signifies a clinical improvement."|24 weeks|PP analysis set|||units on a scale||Standard Error|Least Squares Mean
1398823|NCT01274182|Secondary|Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA|Area under the effect curve of percent change of peripheral B-cell count from baseline to Day 14 (AUEC(0-14d)) of GP2013, MabThera and Rituxan in patients with RA|14 days|PK analysis set|||% * day||Geometric Coefficient of Variation|Geometric Mean
1398824|NCT01274182|Secondary|Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA|Maximum serum concentration (Cmax) after the first infusion of GP2013, MabThera and Rituxan in patients with RA. Samples collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169.|From baseline to week 24|PK Analysis Set|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1398825|NCT01274182|Primary|AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA|Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169|From baseline to 24 weeks|PK Analysis Set|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1399227|NCT01270555|Primary|Self-reported Weekly Substance Use|Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.|baseline and six weeks||||Participants|||Number
1398826|NCT01273896|Primary|Overall Response Rate|To determine the overall response rate using RECIST v 1.1 criteria, defined as PR +CR.using RECIST v 1.1 criteria, defined as Partial response + complete response|Radiological imaging studies to evaluate tumor status will be repeated during the rest week (Days 22 to 28) of every third cycle||||participants|||Number
1398827|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Women|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all the female subjects completed the THI questionnaire.|||units on a scale||Standard Deviation|Mean
1398828|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Men|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all male subjects completed the THI questionnaire.|||units on a scale||Standard Deviation|Mean
1398829|NCT01273883|Secondary|Comparison of Average Tinnitus Handicap Inventory (THI) Across All Subjects|The Tinnitus Handicap Inventory measures the extent that tinnitus interferes with daily activities and sleep.The questionnaire consists of 25 questions, the score can range from 0 (slight problem) to 100 (catastrophic). The score can be converted to a categorical variable as follows: 0-16=Slight; 18-36=Mild; 38-56=Moderate; 58-76=Severe; 78-100=Catastrophic.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the THI questionnaire.|||units on a scale||Standard Deviation|Mean
1398830|NCT01273883|Primary|Tinnitus Distress Rating|This is a single-item patient-reported distress rating on a 0-10 scale, with 0=no tinnitus to 10=worst possible tinnitus.|Pre-treatment, Post-treatment, up to four weeks|Not all subjects completed the distress rating scale.|||units on a scale||Standard Deviation|Mean
1398831|NCT01273857|Secondary|Serious Adverse Events|The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.|3 months to 1 year after cell transplantation||||participants|||Number
1398832|NCT01273857|Primary|Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells|"Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion.~The primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards."|3 months to 1 year after cell transplantation||||participants|||Number
1398833|NCT01273818|Primary|Number of Infections in Each Study Arm|Patients were examined on postoperative 30 days for the presence of surgical site infection.|within the 30 days after surgery||||infections|||Number
1398834|NCT01273818|Primary|Rate of Post-operative Infection||within the first 30 days after surgery|||||||
1398835|NCT01273805|Secondary|Grade 4-5 Treatment-Related Toxicity|All grade 4-5 adverse events with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms.|Adverse events were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1398836|NCT01273805|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to time of objective progression on CT scan or the time of death for patients with clinical deterioration resulting in withdrawal from the trial. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients without an event were censored at date of last disease evaluation.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median PFS follow-up in this study cohort was 46.5 days (95% CI 33-61).|The analysis dataset is comprised of all enrolled patients.|||days||95% Confidence Interval|Median
1398837|NCT01273805|Secondary|Overall Survival|Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death or date last known alive.|All patients were followed until death. Median survival follow-up in this study cohort was 60 days (95% CI: 40-184).|The analysis dataset is comprised of all enrolled patients.|||days||95% Confidence Interval|Median
1398838|NCT01273805|Secondary|Tumor Response Rate|Tumor response rate is the percentage of patients achieving complete or partial response on treatment based on RECIST 1.0 criteria. For target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR for the evaluation of non-target lesions is the disappearance of non-target lesions and normalization of tumor marker level. Appearance of one or more new lesions is classified as progression of non-target lesions. CR or PR confirmation is required >/= 4 weeks.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.|The analysis dataset is comprised of all enrolled patients.|||percentage of patients|||Number
1398839|NCT01273805|Secondary|Biochemical Response Rate|Biochemical response rate was defined as the percentage of patients achieving on treatment a decrease in serum CA 19-9 by > 30% from baseline.|Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.|Biochemical response could not be estimated due to insufficient longitudinal CA 19-9 measurements. This was directly related to the observed lack of activity of the study drug and corresponding short duration of therapy.||||||
1399228|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of ADHD Severity|Global Severity (CGI-S) 1=not ill, 7=extremely ill|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
1398840|NCT01273805|Primary|2-month Progression-Free Survival Rate|2-month progression-free survival rate was defined as the percentage of patients absent progression (PD) or death before 2 months. Patients were considered to have experienced PD if they demonstrated either clinical deterioration resulting in withdrawal or PD per RECIST 1.0 criteria: At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and at the first restaging at 2 months.|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||95% Confidence Interval|Number
1398841|NCT01273766|Secondary|Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months||||Participants|||Count of Participants
1398842|NCT01273766|Secondary|Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics|Records will be assessed at baseline and prospectively while on study.|Baseline, up to 6 months|Number analyzed in rows differs from overall because data was not collected on all participants.|||Participants|||Count of Participants
1398843|NCT01273766|Primary|Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)|Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)|Baseline, up to 6 months||||10^9 Neutrophils per Liter||Standard Deviation|Mean
1398844|NCT01273623|Secondary|Residual Diameter Stenosis|lumen diameter stenosis change post-atherectomy|Day 0||||percentage change||Standard Deviation|Mean
1398845|NCT01273623|Secondary|Adjunctive Therapy Use||Day 0||||percentage of participants|||Number
1398846|NCT01273623|Primary|Luminal Area Change|lumen area change as measured by intravascular ultrasound (IVUS)|Day 0||||mm^2||Standard Deviation|Mean
1398847|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment.|||participants|||Number
1398848|NCT01273597|Secondary|Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy|Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data|||participants|||Number
1398849|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment|Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection).|6 months|Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment.|||participants|||Number
1398850|NCT01273597|Secondary|Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy|Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues).|6 months prior to start of study through baseline|Participants with available retrospective data|||participants|||Number
1398851|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism|If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.||||||
1398852|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance|If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.||||||
1398853|NCT01273597|Secondary|Country–Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance|If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected.|6 months prior to start of study through 6 months of treatment|This outcome measure was not analyzed due to lack of data.||||||
1398854|NCT01273597|Secondary|Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6|Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|All participants|||participants|||Number
1398855|NCT01273597|Primary|Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)|Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L.|6 months|Participants who achieved maintenance dose of Zemplar (paricalcitol injection)|||weeks||Standard Deviation|Mean
1398856|NCT01273519|Primary|Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12|Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.|Baseline, Month 12|All participants with an assessment.|||participants|||Number
1398857|NCT01273519|Secondary|Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12|The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||mg/dL||Standard Deviation|Mean
1398858|NCT01273519|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12|The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||mm/h||Standard Deviation|Mean
1398859|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12|The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398860|NCT01273519|Secondary|Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12|"The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being easy and 10 impossible”) is used to answer the questions on the test."|Baseline, Months 3, 6, 9, 12|Participants with AS or PsA and an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398861|NCT01273519|Secondary|Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12|The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398862|NCT01273519|Secondary|Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12|The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI < 0.5.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398863|NCT01273519|Secondary|Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 [worst] to 100 [best ]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398864|NCT01273519|Primary|Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12|Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.|Baseline, Month 12|All participants with an assessment.|||participants|||Number
1398865|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.|||participants|||Number
1398866|NCT01273519|Primary|Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12|Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).|Baseline, Month 12|All participants with an assessment. n=number of participants with an assessment at time point.|||participants|||Number
1398867|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12|Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question “How intensive was your pain on average in the past 3 months?” on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.|Baseline, Month 12|All participants with an assessment.|||participants|||Number
1398868|NCT01273519|Primary|Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398869|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12|Participants measured their present pain intensity by specifying their level of pain in response to the question “How intensive is your pain at present?” on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.|Baseline, Month 12|All participants with an assessment at time point.|||participants|||Number
1398870|NCT01273519|Primary|Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398871|NCT01273519|Primary|Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12|Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).|Baseline, Months 3, 6, 9, 12|All participants with an assessment. n=number of participants with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1398872|NCT01273181|Primary|Clinical Tumor Regression (Complete Response (CR) + Partial Response (PR)) in Patients With Metastatic Cancer|Tumor regression response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|2 years||||Participants|||Number
1398873|NCT01273181|Primary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|2 years||||Participants|||Number
1398874|NCT01273064|Secondary|Greater Than 2 Log Decline in HCV-RNA at Study Weeks 12, 24 and 48|"Percent of patients experiencing a drop in Hepatitis C virus ribonucleic acid (HCV-RNA, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 12, 24, and 48 weeks of treatment."|Baseline, and Study Weeks 12, 24, and 48|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.|||Percent of participants|||Number
1398875|NCT01273064|Primary|Sustained Virologic Response|Percent of patients that achieve a sustained virologic response (SVR) at Week 72 defined as HCV-RNA (Hepatitis C virus ribonucleic acid, also known as 'viral load') level below the quantification limit (BQL) at Week 72.|Baseline and 24 weeks after the end of treatment (Week 72)|Due to the premature discontinuation of this study and termination of the entire CTS-1027 program, an efficacy analysis was not conducted. No patients completed the study.|||Percent of participants|||Number
1398876|NCT01273038|Primary|Frequency of Ballooning in the Morfeus and SenSura Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|ITT|||percentage of bags|Participants||Number
1398877|NCT01272960|Secondary|Intrauterine Infection|The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)|6 months||||participants|||Number
1398878|NCT01272960|Secondary|Uterine Perforation|The proportion of patients in each arm who experience a uterine perforation|6 months||||participants|||Number
1398879|NCT01272960|Secondary|Mirena Expulsion|The percentage of patients with post-placental placement of Mirena who experience an expulsion|6 weeks||||participants|||Number
1398880|NCT01272960|Primary|Mirena in Place|Proportion of women in each arm with Mirena in place at 6 months|6 months||||participants|||Number
1398881|NCT01272947|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|From randomization to end of day 1||||Hours||Inter-Quartile Range|Median
1398882|NCT01272947|Primary|Pain on Movement|"Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= No pain and 100= Extreme pain"|VAS Score at 24 hours||||mm||Standard Deviation|Mean
1398883|NCT01272934|Secondary|Onset of Pain Relief|Onset of perceptible pain relief.|On day 1||||Hours||Inter-Quartile Range|Median
1398884|NCT01272934|Primary|Pain on Movement|"Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|72 hours||||mm||Standard Deviation|Mean
1398885|NCT01272921|Primary|Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator–Assisted Needle Positioning Beneath the CIEL|Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator–assisted needle positioning beneath the common investing external layer (CIEL).|3 days||||Hours||95% Confidence Interval|Median
1398946|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1398886|NCT01272921|Secondary|Cumulative Probabilities for Needle Positioning Above and Below CIEL.|The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated.|1 Day||||Amplitude (mA)||95% Confidence Interval|Mean
1398887|NCT01272908|Secondary|Change From Baseline in FACIT-F Total Score During the Re-Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1398888|NCT01272908|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score During the Initial Treatment Period|Participant fatigue was evaluated using the FACIT-F scale, a 13-item questionnaire in which the participants were requested to score each item on a 5-point scale. The FACIT-F scores ranged from 0 to 52, with higher scores representing less fatigue. Score changes of 4 points or more were considered clinically meaningful. The total score was a summation of all 13 items, where 2 of the positive items (I have energy; I am able to do my usual activities) were reversed for scoring.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1398889|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
1398890|NCT01272908|Secondary|Percentage of Participants With Disease Remission According to DAS28 in the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score ≤2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
1398891|NCT01272908|Secondary|Change From Baseline CRP During the Re-Treatment Period|CRP levels were measured in mg/L and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
1398892|NCT01272908|Secondary|Change From Baseline in CRP During the Initial Treatment Period|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
1398893|NCT01272908|Secondary|Change From Baseline in ESR During the Re-Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1398894|NCT01272908|Secondary|Change From Baseline in ESR During the Initial Treatment Period|ESR was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1398895|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Re-Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determines the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if >2 categories were missing.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1398896|NCT01272908|Secondary|Change From Baseline HAQ-DI Score During the Initial Treatment Period|HAQ-DI: 20 questions, 8 categories of functioning: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common usual activities. Participants report amount of difficulty in performing 2-3 specific subcategory items. Difficulty score is from 0 to 3 (0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; and 3 = unable to do). The highest component score in each of the 8 categories determined the score for that category, unless aids, devices, and/or help from another person were required which = a score of 2 (unless already 2 or 3). The 8 category scores were averaged into overall HAQ-DI score ranging from 0 to 3 (0 to 1 = mild to moderate difficulty; 1 to 2 = moderate to severe disability; and 2 to 3 = severe to very severe disability). HAQ-DI not computed if > 2 categories were missing.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1398897|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Re-Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1398898|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Pain During the Initial Treatment Period|Patient Global Assessment of Pain was measured using a 100-mm VAS where the extreme left end of the line was 0 = no pain and the extreme right end of the line was 100 = unbearable pain. The participant was asked to mark the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1398899|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity During the Re-Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period and Week 4 after last maintenance|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1398900|NCT01272908|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Score During the Initial Treatment Period|Patient Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The participant was asked to marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1398901|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Re-Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm VAS where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1398902|NCT01272908|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity During the Initial Treatment Period|Physician Global Assessment of Disease Activity was measured using a 100-mm visual analog scale (VAS) where the extreme left end of the line was 0 = no disease activity and the extreme right end of the line was 100 = maximum disease activity. The physician marked the line and the distance from the left edge was measured in mm.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1398903|NCT01272908|Secondary|Change From Baseline in TJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
1398904|NCT01272908|Secondary|Change From Baseline in TJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specific parameter at a given visit.|||tender joints||Standard Deviation|Mean
1398905|NCT01272908|Secondary|Change From Baseline in SJC During the Re-Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given vist.|||swollen joints||Standard Deviation|Mean
1398906|NCT01272908|Secondary|Change From Baseline in SJC During the Initial Treatment Period|Joints assessed for swelling consisted of shoulders, elbows, wrists, interphalangeal (digit 1), distal interphalangeal joints (digits 2-5), proximal interphalangeal joints (digits 2-5), metacarpophalangeal joints (digits 1-5), and knees.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
1398907|NCT01272908|Secondary|Change From Baseline in DAS28 During the Re-Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 12 and 24 of Re-treatment period|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1398908|NCT01272908|Secondary|Change From Baseline in DAS28 During the Initial Treatment Period|The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria. A change of 1.2 units in DAS28 in an individual participant was considered a significant change.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1399229|NCT01270555|Secondary|Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity|CGI-S 1=not ill, 7=extremely ill|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
1398909|NCT01272908|Secondary|Percentage of Participants Meeting EULAR Response Criteria During the Re-Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score ≤3.2), moderate (DAS28 score >3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
1398910|NCT01272908|Secondary|Percentage of Participants Meeting European League Against Rheumatism (EULAR) Response Criteria During the Initial Treatment Period|The EULAR response criteria were based on the assessment of disease activity using the DAS28. The EULAR response criteria included not only change in disease activity but current disease activity. To be classified as responders, participants had to have a significant change in DAS28 and a low current disease activity. There were 4 categories of EULAR response rates: good, moderate, good/moderate, and none. The DAS28 scoring used 4 core components: SJC, TJC, Patient’s Global Assessment of Disease Activity, and ESR. The DAS28 has a continuous scale ranging from 0 to 9.4. The level of disease activity was interpreted as low (DAS28 score less than or equal to [≤]3.2), moderate (DAS28 score greater than [>]3.2 but ≤5.1), or high (DAS28 score >5.1). A DAS28 score <2.6 corresponded to a state of remission according to American Rheumatism Association criteria.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
1398911|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Re-Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
1398912|NCT01272908|Secondary|Percentage of Participants Meeting ACR Response Criteria During the Re-treatment Period|ACR20/50/70, defined as ≥20%, 50%, or 70% improvement, respectively, compared to baseline in TJC and SJC, and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; HAQ-DI; and an acute phase reactant (ESR or CRP). If CRP was missing or not done, then ESR was used.|Weeks 12 and 24 of Re-treatment period|ITT Population|||percentage of participants|||Number
1398913|NCT01272908|Secondary|Percentage of Participants With Complete Clinical Response Per ACR Criteria During the Initial Treatment Period|Complete clinical response was defined as having an ACR70 for at least 13 weeks.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
1398914|NCT01272908|Secondary|Percentage of Participants Meeting American College of Rheumatology (ACR) Response Criteria During the Initial Treatment Period|ACR20/50/70, defined as ≥20 percent (%), 50%, or 70% improvement, respectively, compared to baseline in tender joint count (TJC) and swollen joint count (SJC), and 20%/50%/70% improvement in at least 3 of 5 additional ACR core set variables: Patient Assessment of Pain; Patient's Global Assessment of Disease Activity; Physician's Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and an acute phase reactant (erythrocyte sedimentation rate [ESR] or C-Reactive Protein [CRP]). If CRP was missing or not done, then ESR was used.|Weeks 4, 12, 24, 36, and 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
1398915|NCT01272908|Secondary|Percentage of Participants With Adverse Events During the Re-Treatment Period - Overall Summary|Percentage of participants who reported an AE or SAE, a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Re-treatment period|ITT Population|||percentage of participants|||Number
1398916|NCT01272908|Primary|Percentage of Participants With Adverse Events During the Initial Treatment Period - Overall Summary|Percentage of participants who reported an AE or serious AE (SAE), a drug-related AE, who had an acute infusion reaction, an AE leading to study drug discontinuation, with an infection or serious infection, or who died.|Days 1, 2, 15, and 16 and Week 48 of Initial treatment period|ITT Population|||percentage of participants|||Number
1398917|NCT01272882|Primary|Feasibility of EIT Monitoring in This Population of ARDS/ALI Patients|Feasibility for the purposes of our study was the ability to apply the device to a diverse population of ARDS/ALI patients and obtain EIT data from the device.|At the start of monitoring once the patient was consented and enrolled.||||Patients successfully monitored with EIT|||Number
1398918|NCT01272869|Primary|Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.|Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.|Daily or at every change of bag in a period of a maximum of 28 days|Intention to treat (ITT)|||percentage bags with ballooning|Participants||Number
1398919|NCT01272830|Secondary|Deoxypyridinoline Levels|"The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrlinks-D enzyme-linked immunosorbent assay kits from R&D Systems(minneapolis, MN) and Metra Biosystems (Mountain View, CA) respectively.~Lower DPD concentrations represent a better outcome"|Baseline and 13 Weeks||||nmol/L||Standard Deviation|Mean
1398920|NCT01272830|Secondary|TGFBeta Levels|"The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrilinks-D enzyme-linked immunosorbent assay kits from R&D Systems (Minneapolis, MN) and Metra Biosystems (Mountain View, CA), respectively.~Lower TGFBeta concentrations represent a better outcome."|Baseline and 13 Weeks||||pg/mL||Standard Deviation|Mean
1398945|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Full Range|Median
1398921|NCT01272830|Secondary|Surrogate Endpoint Markers (SEBs)|"HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.~Scale range HSS total: 100-90 Excellent; 80-89 Very Good; 70-79 Good; 60-69 Fair; below 60 Poor~Scale range HSS pain walking: No Pain 15; Mild Pain 10; Moderate Pain 5; Severe Pain 0 (**this is an element of the HSS total)~Scale range KSS: 80-100 Excellent; 70-79 Good; 60-69 Fair; below 60 Poor"|13 weeks||||units on a scale||Standard Deviation|Mean
1398922|NCT01272830|Primary|Pain Visual Analog Scale (VAS)|"Pain Visual Analog Scale (VAS)~Scale range (0-100) A higher VAS score indicate worse knee pain"|13-weeks||||units on a scale||Standard Deviation|Mean
1398923|NCT01272804|Secondary|Change From Baseline in Lactate Level at Day 6 and 14|Baseline value was collected at 0 hour on Day 1 for lactate.|Baseline (Day 1), Day 6 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
1398924|NCT01272804|Secondary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
1398925|NCT01272804|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
1398926|NCT01272804|Secondary|Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
1398927|NCT01272804|Secondary|Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up|Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.|Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
1398928|NCT01272804|Secondary|Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15||Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
1398929|NCT01272804|Secondary|Change From Baseline in Average Plasma Glucose at Day 1, 6, 14|Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC [0-24]) divided by 24.|-46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||mg/dL||Standard Deviation|Mean
1398930|NCT01272804|Secondary|Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||percent change||Standard Deviation|Mean
1398931|NCT01272804|Secondary|Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14|Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively.|||percent change||Standard Deviation|Mean
1398932|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1398933|NCT01272804|Primary|Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1|Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)|Pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter.|||percent change||Standard Deviation|Mean
1398934|NCT01272804|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax)|Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1398935|NCT01272804|Primary|Observed Accumulation Ratio for AUCtau (Rac)|Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1398936|NCT01272804|Primary|Apparent Volume of Distribution (Vz/F) on Day 14|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
1398937|NCT01272804|Primary|Apparent Oral Clearance (CL/F) on Day 14|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
1398938|NCT01272804|Primary|Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14|Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.|0 hour (pre-dose) through 24 hours post-dose on Day 14|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of dose||Standard Deviation|Mean
1398939|NCT01272804|Primary|Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1398940|NCT01272804|Primary|Plasma Decay Half-Life (t1/2) on Day 14|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Standard Deviation|Mean
1398941|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14|AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1398942|NCT01272804|Primary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Full Range|Median
1398943|NCT01272804|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1398944|NCT01272804|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1|AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.|0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1398947|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 6||0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)|PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1398948|NCT01272804|Primary|Maximum Observed Plasma Concentration (Cmax) On Day 1||0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)|Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1398949|NCT01272804|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1398950|NCT01272661|Secondary|Breastfeeding Rate at 6 Months Postpartum|Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum|ITT analysis conducted on participants with available data|||participants|||Number
1398951|NCT01272661|Secondary|Breastfeeding Rate at 3 Months Postpartum|Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.|Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum|ITT analysis conducted on participants with available data|||participants|||Number
1398952|NCT01272661|Secondary|Breastfeeding Rate at One Month Postpartum|Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.|Any and exclusive breastfeeding at one month, between 21-38 days postpartum|ITT analysis conducted on participants with available data|||participants|||Number
1398953|NCT01272661|Secondary|Breastfeeding Rate|Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.|Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours|ITT analysis was conducted on participants with available data|||participants|||Number
1398954|NCT01272661|Primary|Program Feasibility - Curriculum Modules|Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11|by 24 months from program start||||modules presented||Inter-Quartile Range|Mean
1398955|NCT01272661|Primary|Program Feasibility- Feeding Outcome Collected|Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome|by 24 months|Total number of eligible MomsFirst participants who agreed to data sharing. Outcome shows number w/ any feeding outcome (not lost to follow up, no live birth, case closed by MomsFirst). This is for a 24 month period since all data was de-identified and stripped of dates so unable to specify for 12 month period|||participants|||Number
1398956|NCT01272635|Secondary|Drug Related Side Effects|Parent-reported gastrointestinal symptoms during treated RTI.|14 days after initiation of therapy||||events|||Number
1398957|NCT01272635|Secondary|Urgent Care Visits, ED Visits and Hospitalizations|Number of participants who had urgent care visits, ED visits, and/or hospitalizations for respiratory symptoms.|14 days after initiation of therapy|All participants who initiated APRIL therapy|||participants|||Number
1398958|NCT01272635|Secondary|Absence From School, Daycare, and/or Parental Work||14 days after initiation of therapy|Data were of insufficient quality to be analyzed.||||||
1398959|NCT01272635|Secondary|Asthma Related Symptoms Among RTI Progressing to Severe LRTI|Asthma related symptoms as measured by the parent-completed Pre-school Asthma Symptom Diary (PAD). The PAD was completed daily starting on the first day of an illness and continued until the participant was symptom-free for 2 days. It contains questions of frequency of respiratory symptoms, each scored on a scale of 1 through 7, with higher scores representing increasingly frequent symptoms, with daily scores ranging from 0 (asymptomatic) to a maximum of 102. The total PAD score is the sum of the daily individual symptom scores over the duration of the illness, with higher scores representing more frequent symptoms.|14 days after initiation of therapy|Respiratory Tract Infections (RTI) progressing to Severe Lower RTI|||PAD score||Standard Deviation|Mean
1398960|NCT01272635|Primary|OCELOT: Pediatric Respiratory Assessment Measure|The Pediatric Respiratory Assessment Measure (PRAM) is a composite outcome with scores ranging from 0-12 with higher numbers representing worse symptoms. The score is calculated as the sum total of the follow five elements: (1) scalene retractions, (2) suprasternal retractions, (3) wheezing, (4) air entry, (5) oxygen saturation. A complete description can be found in: Ducharme FM, Chalut D, Plotnick L, et al. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr 2008;152:476-80.|36-72 hours after initiation of OCELOT therapy|Participants who developed severe lower respiratory tract infections and initiate blinded OCELOT therapy.|||PRAM score||Standard Deviation|Mean
1398961|NCT01272635|Primary|Progression to Clinically Significant Lower Respiratory Tract Symptoms|Progression to clinically significant lower respiratory tract symptoms defined by: (1) having symptoms that were more than mild after 3 albuterol administrations over 1 hour, or (2) requiring albuterol administrations more often than once every 4 hours, or (3) requiring more than 6 albuterol treatments over a 24-hour period, or (4) having moderate to severe cough or wheeze for 5 or more days since study medication was initiated.|14 days after initiation of APRIL therapy|All participants who initiated APRIL therapy|||participants|||Number
1402966|NCT01238588|Secondary|Hemoglobin Level||Baseline and 6 months|Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source)||||||
1398962|NCT01272583|Secondary|Symptomatic Hormone Responses to Acute Hypoglycaemia.|The symptomatic responses to hypoglycaemia were assessed using a standard validated symptom questionnaire adapted for experimental hypoglycaemia (McCrimmon et al (2003) Diabet.Med. 20: 507-509). A 7-point Likert scale (1=symptom absent; 7=symptom experienced with great intensity) was used to score presence and intensity of autonomic and neuroglycopenic symptoms of hypoglycaemia. Symptom scores were obtained during the initialisation phase, at occurrence of autonomic reaction and again 30 minutes later. For analyses the scale was considered as a continuous variable.|Change from baseline symptomatic response at hypoglycaemia and 30 minutes after hypoglycaemia||||units on a scale||Inter-Quartile Range|Median
1398963|NCT01272583|Secondary|Cortisol Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||mU*minutes/L||Inter-Quartile Range|Median
1398964|NCT01272583|Secondary|Growth Hormone Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||mU*minutes/L||Inter-Quartile Range|Median
1398965|NCT01272583|Secondary|Norepinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||nmol*minutes/L||Inter-Quartile Range|Median
1398966|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20 and 40 minutes||||pmol*minutes/L||Inter-Quartile Range|Median
1398967|NCT01272583|Secondary|Epinephrine Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||nmol*minutes/L||Inter-Quartile Range|Median
1398968|NCT01272583|Secondary|Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia|Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.|0, 10, 20, 40 minutes||||pmol*minutes/L||Inter-Quartile Range|Median
1398969|NCT01272583|Primary|Glucagon Response to Acute Hypoglycaemia|Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia|Change from initialisation phase to 40 minutes after onset of hypoglycaemia||||pmol/L||Inter-Quartile Range|Median
1398970|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 12 Months"|"Success defined as a response of Very Much Better or Much Better at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|12 months|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the PGI-I.|||percentage of participants|||Number
1398971|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the IIQ-7.|||percentage of participants|||Number
1398972|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months|Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 2 subjects either missed the visit or did not complete the UDI-6.|||percentage of participants|||Number
1398973|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 12 Months|"Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST).~The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the cough stress test.|||percentage of participants|||Number
1398974|NCT01272284|Secondary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months|Success defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months.|12 months (compared to baseline)|105 subjects were eligible for 12-month follow-up. 4 subjects missed either the visit or the pad weight test.|||percentage of participants|||Number
1398975|NCT01272284|Secondary|"Percentage of Patients Responding Very Much Better or Much Better on PGI-I at 6 Months"|"Success defined as a response of Very Much Better or Much Better at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I)."|6 months|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the PGI-I.|||percentage of participants|||Number
1398976|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 5 subjects either missed the visit or did not complete the Incontinence Impact Questionnaire.|||percentage of participants|||Number
1398977|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months|Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 4 subjects either missed the visit or did not complete the Urinary Distress Inventory.|||percentage of participants|||Number
1398978|NCT01272284|Secondary|Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months|"Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.~Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced."|6 months (compared to baseline)|109 subjects were eligible for 6-month follow-up. 17 subjects either missed the visit or did not complete the 3-Day Voiding Diary.|||percentage of participants|||Number
1398979|NCT01272284|Secondary|Percentage of Participants With Negative Cough Stress Test at 6 Months|"Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%.~The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test."|6 months|109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the cough stress test.|||percentage of participants|||Number
1398980|NCT01272284|Primary|Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months|Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.|6 months (compared to baseline)|Analysis was per protocol. 109 subjects were eligible for 6-month follow-up. 6 subjects missed either the visit or the pad weight test.|||percentage of participants|||Number
1398981|NCT01272245|Secondary|Induction Mortality|Death within 8 weeks from the start of treatment.|Up to 1 year||||Participants|||Count of Participants
1398982|NCT01272245|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause|Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.||||Months||Full Range|Median
1398983|NCT01272245|Secondary|Disease-free Survival|Time from date of treatment start until the date of first objective documentation of disease-relapse.|Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.||||Months||Full Range|Median
1398984|NCT01272245|Secondary|Evaluation of CR Duration|The date of Complete Response to the date of loss of response or last follow-up.|Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.||||Months||Full Range|Median
1398985|NCT01272245|Primary|Percentage of Participants With Complete Remission (CR)|Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia|Up to 4 months||||percentage of participants|||Number
1398986|NCT01272232|Secondary|Incidence of Hypoglycaemic Episodes|Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level below 3.1 mmol/L [56 mg/dL]).|Weeks 0-56|Safety analysis set, comprising all randomised subjects who had been exposed to at least one dose of trial product.|||Episodes/100 years of patient exposure|||Number
1398987|NCT01272232|Secondary|Change From Week 56 to 68 in Waist Circumference||Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||cm||Standard Deviation|Mean
1398988|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||cm||Standard Deviation|Mean
1398989|NCT01272232|Secondary|Change (%) From Week 56 to 68 in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 56, week 68|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percent change||Standard Deviation|Mean
1398990|NCT01272232|Secondary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 68|Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percent change||Standard Deviation|Mean
1398991|NCT01272232|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||cm||Standard Deviation|Mean
1398992|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
1398993|NCT01272232|Secondary|Proportion of Subjects Reaching Target HbA1c Below 7%||at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
1398994|NCT01272232|Secondary|Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)|Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage point change of HbA1c||Standard Deviation|Mean
1398995|NCT01272232|Primary|Proportion of Subjects Losing More Than 10% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
1398996|NCT01272232|Primary|Proportion of Subjects Losing at Least 5% of Baseline Body Weight|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|at 56 weeks|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percentage of subjects|||Number
1398997|NCT01272232|Primary|Change (%) From Baseline in Body Weight (Fasting)|Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.|Week 0, week 56|Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.|||percent change||Standard Deviation|Mean
1398998|NCT01272219|Secondary|Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).|Week 0, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percent change||Standard Deviation|Mean
1398999|NCT01272219|Secondary|Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)|The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).|Week 56, Week 68|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percent change||Standard Deviation|Mean
1399000|NCT01272219|Secondary|Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|Percentage of subjects losing >=5% and percentage of subjects losing >10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||percentage of subjects|||Number
1399001|NCT01272219|Secondary|Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||percent change||Standard Deviation|Mean
1399002|NCT01272219|Secondary|Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment|Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||percentage of subjects|||Number
1399003|NCT01272219|Secondary|Pre-diabetes Status After 56 Weeks of Treatment|Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percentage of subjects|||Number
1399004|NCT01272219|Secondary|Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)|The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|Week 0, week 160|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||cm||Standard Deviation|Mean
1399230|NCT01270555|Primary|Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score|Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)|baseline and six weeks||||Units on a scale||Standard Deviation|Mean
1399005|NCT01272219|Secondary|Change From Baseline in Waist Circumference (cm)|The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||cm||Standard Deviation|Mean
1399006|NCT01272219|Primary|Proportion of Subjects With Onset of Type 2 Diabetes|Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).|At 160 weeks|Subjects included in the FAS, who were stratified to 160-weeks of treatment; all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and with at least one post-baseline efficacy measurement, who were stratified to 160-weeks of treatment. Missing data were imputed using LOCF.|||Subject|||Number
1399007|NCT01272219|Primary|Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight|Percentage of subjects losing >10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At 56 weeks|The FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percentage of subjects|||Number
1399008|NCT01272219|Primary|Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.|Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).|At Week 56|The FAS included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using LOCF.|||percentage of subjects|||Number
1399009|NCT01272219|Primary|Change From Baseline in Fasting Body Weight|The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).|Week 0, Week 56|The full analysis set (FAS) included all randomised subjects who were exposed to at least one dose of trial product (liraglutide 3.0 mg or liraglutide placebo) and who provided at least one post-baseline efficacy value. Missing data were imputed using last observation carried forward (LOCF).|||percent change||Standard Deviation|Mean
1399010|NCT01272193|Secondary|Change in Body Weight|Observed change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
1399011|NCT01272193|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1399012|NCT01272193|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1399013|NCT01272193|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1399014|NCT01272193|Secondary|Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal|Observed mean increment of the 9-point self-measured plasma glucose profile (SMPG) at the main evening meal|Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||mmol/L||Standard Deviation|Mean
1399015|NCT01272193|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Observed change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1399026|NCT01272141|Primary|The Safety and Toxicity of the Combination Therapy of Lapatinib and Everolimus Will be Monitored Using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 3.0. The Incidence of Any Grade 3 or 4 Toxicities Will be Analyzed.||Safety assessments will be performed every four weeks while the patient remains on study.|No data were collected due to early termination.||||||
1399027|NCT01272141|Primary|Overall Response Rate Will Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Tumor Assessment for All Lesions Must be Performed Every Eight Weeks While on Study by CT Scan.||Tumor assessment for all lesions must be performed by CT scan every 8 weeks while on study.|No data were collected due to early termination.||||||
1399282|NCT01269918|Secondary|Heart Rate|Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.||||beats per minute||Standard Deviation|Mean
1399016|NCT01272180|Primary|Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.|The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.|One month after the second vaccination (Day 91)|"Analysis was done on the Per Protocol Set - desirability, ie, all subjects who :~correctly received the vaccine at Visit 1 and Visit 2, provided evaluable serum samples pre- (Visit 1) and post-vaccination (Visit 3), provided post-vaccination solicited adverse event data an had no major protocol violation as defined prior to unblinding."|||Desirability index|||Number
1399017|NCT01272180|Secondary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.|Throughout the study ( Day 1 to Day 241)|Analysis was done on the unsolicited safety set, ie, all subjects in the all exposed set who provided postvaccination unsolicited AE data.|||Participants|||Number
1399018|NCT01272180|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.|The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.|Day 1 through day 7 after any vaccination|Analysis was done on the solicited safety set, ie all subjects in the all exposed set who provided postvaccination solicited AE data from day 1 (6 hours) through day 7. The all exposed set is defined as all subjects in the all enrolled population who actually received a study vaccination.|||Participants|||Number
1399019|NCT01272180|Secondary|The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|One month after the second vaccination/prevaccination (Day 91/day 1)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
1399020|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.|||Titers||95% Confidence Interval|Geometric Mean
1399021|NCT01272180|Secondary|Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|"The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.~4-fold increase is defined as follows;~for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase."|One month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity.|||Percentages of subjects||95% Confidence Interval|Number
1399022|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per-protocol population, immunogenicity|||Percentages of subjects||95% Confidence Interval|Number
1399023|NCT01272180|Secondary|The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.|Day 1 and one month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.|||Titers||95% Confidence Interval|Geometric Mean
1399024|NCT01272180|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.|Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.|Day 1 and one month after second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity.|||Percentages of subjects||95% Confidence Interval|Number
1399025|NCT01272180|Primary|Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.|"Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y.~Seroresponse is defined as:~For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8;~For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer.~Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA)."|One month after the second vaccination (Day 91)|Analysis was done on the per protocol population, immunogenicity, i.e subjects who received correct vaccines in both the visits; provided evaluable serum sample pre and post vaccination with assay results available for at least one serogroup and/or strain and had no major protocol violations.|||Percentages of subjects||95% Confidence Interval|Number
1402967|NCT01238588|Secondary|Erythropoiesis Stimulating Agent (ESA) Dose Requirement||Baseline and 6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study (per funding source).||||||
1399028|NCT01272076|Primary|Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).|In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.|August 2011|Subjects with dry AMD and Geographic Atrophy. The required sample size was calculated based on previous experience with the device and its variability.|||mm^2||Standard Deviation|Mean
1399029|NCT01272011|Secondary|Ventilatory Loading - Phase 3|Ventilatory load compensation was assessed in two ways. Mean slopes for (1) pressure vs. resistance (P vs R) and (2) airflow vs. resistance (AF vs R) were calculated for pre- and post-IH treatment.|Pre- versus Post-treatment|Data were collected from 3 participants. However, clinical observations revealed results of interest from only 1/3 of the participants. Therefore, data from only this 1 individual were analyzed for presentation as a case study. The data from the other 2 participants were not analyzed.|||unitless||Standard Error|Mean
1399030|NCT01272011|Primary|Minute Ventilation - Phase 2|Minute ventilation (Ve) is the volume of gas inhaled or exhaled from a person's lungs per minute. Minute ventilation during the end-recovery (ER) period at initial (i.e., Days 1 and 2, initial ER period) and final (i.e., Days 9 and 10, final ER period) days of the IH protocol were normalized to values from baseline with elevated carbon dioxide (B2) within each individual session to characterize daily effects of exposure to IH at the beginning and end of treatment. Values from baseline with elevated carbon dioxide and the ER period during the final days of the protocol (final B2 and final ER period, respectively) also were normalized to elevated carbon dioxide baseline during initial days of the protocol (initial B2) to describe the cumulative effects of repeated exposure to IH. Outcomes are reported as % increases in minute ventilation during initial and final treatment sessions for daily/acute effects and cumulative/chronic effects.|Pre- versus Post-treatment||||percentage of baseline||Standard Error|Mean
1399031|NCT01271946|Secondary|Time to Ambulation|Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per Protocol-Diagnostic Cohort.|||Hours||Standard Deviation|Mean
1399032|NCT01271946|Secondary|Time to Hemostasis|Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.|Hemostasis was evaluated immediately following procedural sheath removal.|Per protocol-Diagnostic Cohort.|||Minutes||Standard Deviation|Mean
1399033|NCT01271946|Primary|Percentage of Participants With Bed Elevation Within 15 Minutes.|Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.|Post procedure|Per protocol.|||Percentage of participants|||Number
1399034|NCT01271946|Primary|Time to Ambulation|Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.|Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.|Per protocol.|||Hours||Standard Deviation|Mean
1399035|NCT01271946|Primary|Time to Actual Discharge|The time from sheath removal to actual hospital discharge.|Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.|Per protocol.|||Hours||Standard Deviation|Mean
1399036|NCT01271946|Primary|Time to Discharge Eligibility|The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.|Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.|Per Protocol.|||Hours||Standard Deviation|Mean
1399037|NCT01271946|Primary|Time to Hemostasis|The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.|Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.|Per protocol.|||Minutes||Standard Deviation|Mean
1399038|NCT01271946|Primary|Minor Adverse Events|Observation of any minor access site-related complications.|Procedure through 30 day follow-up.||||Percentage of participants|||Number
1399039|NCT01271946|Primary|Device Success|Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.|Procedure|Intent to treat.|||Percentage of participants|||Number
1399040|NCT01271946|Primary|Major Adverse Events Reported as Percentage of Participants With Adverse Events.|Observation of any major access site-related complication (percentage of participants).|Procedure through 30 day follow-up.||||Percentage of participants|||Number
1399041|NCT01271946|Primary|Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.||Procedure through 30 days follow-up.|||||||
1399042|NCT01271907|Secondary|Investigate Low-dose Systemic Aldesleukin to Cell Efficacy|Low-dose systemic aldesleukin will be evaluated to determine cell activity in metastatic melanoma.|7 months|Zero participants were analyzed for this outcome measure. Greater than 10 participants were needed to evaluate this outcome measure. These were not explored in the small number of patients studied.||||||
1399043|NCT01271907|Primary|Safety of Drosophila Generated PBL Administered in Combination With a Lymphodepleting Preparative Regimen and Supportive Systemic Aldesleukin|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.|||Participants|||Count of Participants
1399055|NCT01271803|Primary|Cmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1399044|NCT01271907|Primary|Clinical Response|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression disease (PD) is at least a 20 % increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|7 months|Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.|||Participants|||Count of Participants
1399045|NCT01271855|Secondary|Patient Satisfaction|Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied).|Discharge|The pain satisfaction at discharge score is unknown for eight participants in the Belladonna and opioid suppository group, and the pain satisfaction at discharge score is unknown for six participants in the Glycerin suppository group.|||units on a scale||Inter-Quartile Range|Median
1399046|NCT01271855|Secondary|Number of Patients Taking Additional Pain Medications|Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.|Twenty-four hours||||Participants|||Count of Participants
1399047|NCT01271855|Primary|Pain Level Twenty Four Hours After Delivery|The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).|Twenty-four hours|The 24-hour visual analogue pain score for two participants in the Belladonna and opioid suppository group is unknown, and the 24-hour visual analogue pain score for one participant in the Glycerin suppository group is unknown|||units on a scale||Inter-Quartile Range|Median
1399048|NCT01271803|Secondary|Pharmacodynamics: Number of Participants With Mitogen-Activated Protein Kinase (MAPK) Inhibition, as Assessed by Immunohistochemistry (IHC)|Changes in effector molecules of the MAPK pathway that are directly or indirectly affected by BRAF and MEK inhibition (including but not limited to ERK and phosphorylated ERK and MEK) by IHC using biopsies at baseline, between Days 10−14 of Cycle 1, and at disease progression. IHC is a staining process performed on fresh/frozen tumor tissue samples.|At baseline; Cycle 1: Day 14; at disease progression (Up to 32 months)|Number of participants analyzed=number of participants available for analysis of this outcome measure.|||participants|||Number
1399049|NCT01271803|Secondary|Average Percent Change From Baseline in Fluorodeoxyglucose-positron Emission Tomography (FDG-PET) at Cycle 1 and Cycle 2|The pharmacodynamic effect of cobimetinib in combination with vemurafenib was assessed by measuring changes in FDG uptake as characterized by the lean body mass corrected (LBM) maximum standardized uptake value (SUV max) measurement using FDG-PET. Post-baseline timepoint Cycle 1 was averaged between Days 10 to 14 and Cycle 2 for Days 14+7.|Cycle 1 (Days 10 to 14), Cycle 2 (Days 14+7)|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Percent change in FDG-PET||Standard Deviation|Mean
1399050|NCT01271803|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up. OS analyzed using Kaplan-Meier estimate.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.|||months||95% Confidence Interval|Median
1399051|NCT01271803|Secondary|Median Duration of Response (DOR)|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST v 1.1, or death from any cause during the study (that is within 30 days after the last dose of study treatment).|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) and had an objective response (of CR or PR) was included in the analysis of this outcome.|||months||95% Confidence Interval|Median
1399052|NCT01271803|Secondary|Percentage of Participants With Disease Progression According to RECIST V 1.1|Progressive disease (PD) according to RECIST V 1.1: at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (nadir), including baseline; in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of 1 or more lesions is also considered as progression.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.|||percentage of participants|||Number
1399053|NCT01271803|Secondary|Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1|Tumor response of CR or PR is considered as objective response. CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Screening to up to data cut-off (01 October 2013) (assessed at screening [within 28 days prior to initiation of Cycle 1], every 6 weeks thereafter until disease progression or death or data cut-off [01 October 2013]) up to 32 months|Safety evaluable population who received combination study treatment (Cobimetinib + Vemurafenib) was included in the analysis of this outcome.|||percentage of participants||95% Confidence Interval|Number
1399054|NCT01271803|Primary|Tmax of Vemurafenib on Day 14, Cycle 1||Predose (0 hr) on Days 14, 15; 0.5, 1, 2, 4, 6, 8 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1399059|NCT01271803|Primary|Tmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.|||hours||Full Range|Median
1399060|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 of Cohorts 1C and 2A in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Day -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.|||mcg/mL||Standard Deviation|Mean
1399061|NCT01271803|Primary|Cmax of Vemurafenib on Day -1, Cycle 1 in Participants Previously Treated With Vemurafenib Prior to Enrollment Into This Study||Predose (0 hr) on Days -1, 1; 2, 4, 6, 8 hr postdose on Day -1|PK population. Here, number of participants analyzed = participants who were previously treated with vemurafenib prior to enrollment into this study.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1399062|NCT01271803|Primary|Clearance (CL) of Cobimetinib on Day 14 (Steady State), Cycle 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1399063|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 14, Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1399064|NCT01271803|Primary|Tmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1399065|NCT01271803|Primary|Cmax of Cobimetinib on Day 14 (Steady State), Cycle 1||Cycle 1: predose (0 hr) on Days 8, 14; 0.5, 1, 2, 4, 6 hr postdose on Day 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1399066|NCT01271803|Primary|AUC0-24 of Cobimetinib on Day 1, Cycle 1 of Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Standard Deviation|Mean
1399067|NCT01271803|Primary|Area Under Concentration Versus Time Curve (AUC) Over a Period of 24 Hours (AUC0-24) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1399068|NCT01271803|Primary|Time Taken to Reach Maximum Plasma Concentration (Tmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1399069|NCT01271803|Primary|Cmax of Cobimetinib on Day 1, Cycle 1 in Cohort 3||Cycle 1: predose (0 hr) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Standard Deviation|Mean
1399070|NCT01271803|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 1, Cycle 1||Cycle 1: predose (0 hours [hr]) on Days 1, 2; 0.5, 1, 2, 4, 6 hr postdose on Day 1|PK population included all participants who received study treatment and had at least one vemurafenib and cobimetinib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1399071|NCT01271803|Primary|Maximum Tolerated Doses (MTD) of Vemurafenib and Cobimetinib When Administered in Combination in DES|The highest dose level(s) at which fewer than one-third of participants experienced a DLT was declared the MTD. DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade ≤1 within 7 days, b) Grade 3 rash/photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cuSCC that was subsequently resected, d) Grade ≥3 fatigue/hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum CPK levels, which is asymptomatic, deemed to be clinically insignificant and returns to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (ANC <500/ μL), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mg|||Number
1399072|NCT01271803|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During DES in Combination Cohorts|DLT is defined as 1 of the following toxicities considered by the investigator to be related to study treatment: a) Grade 3 nausea, vomiting or diarrhea that resolved to Grade less than or equal to (≤) 1 within 7 days, b) Grade 3 rash or photosensitivity that resolved to Grade ≤2 within 7 days, c) Grade 3 cutaneous squamous cell carcinoma (cuSCC) that was subsequently resected, d) Grade greater than or equal to (≥) 3 fatigue or hyperuricemia that resolved to Grade ≤2 within 7 days, e) Grade 3 fever, f) Grade 3 or 4 elevation of serum creatine phosphokinase (CPK) levels, which is asymptomatic, deemed by the investigator to be clinically insignificant and that returned to Grade ≤2 during the 14-day cobimetinib treatment holiday, g) Grade ≥3 febrile neutropenia, h) Grade ≥4 neutropenia (absolute neutrophil count [ANC] less than <500/microliter [μL]), i) Grade ≥4 thrombocytopenia, j) Grade ≥4 anemia, k) Grade ≥3 elevation of total bilirubin, hepatic transaminase or alkaline phosphatase.|28 Days|Safety-evaluable population (SEP) included all participants who received at least one dose of study drug. SEP participants who received combination study treatment (cobimetinib + Vemurafenib) were included in the analysis of this outcome. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
1399133|NCT01270958|Primary|White Blood Cell Count at Baseline and After Treatment Completion|White blood cells are cells of the immune system that defend the body against both infectious disease and foreign materials. Normal range: 4-10 10^9 cells per liter (Giga/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||Giga/L||Standard Deviation|Mean
1399073|NCT01271712|Secondary|Duration of Response (DOR)|Duration of Response was defined as the time from date of first response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).] or Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.]) to the date when Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.) is first documented, or to the date of death, whichever occurs first, according to RECIST v1.1. Subjects still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. Duration of response defined for responders only, i.e CR or PR. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set with response participants|||Days||95% Confidence Interval|Median
1399074|NCT01271712|Secondary|Disease Control Rate (DCR)|Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)|||Percentage of Participants||95% Confidence Interval|Number
1399075|NCT01271712|Secondary|Objective Response Rate|Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.|Full Analysis Set (FAS)|||Percentage of Participants||95% Confidence Interval|Number
1399076|NCT01271712|Secondary|Tumor Response|Tumor Response of a subject was defined as the best tumor response (Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).], Partial Response [PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], Stable Disease [SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.], or Progressive Disease [PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.|From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)|||Percentage of Participants||95% Confidence Interval|Number
1399077|NCT01271712|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST [Response Evaluation Criteria in Solid Tumors] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
1399078|NCT01271712|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system.|From randomization of the first subject until date of database cutoff (08 Jun 2015)|Full Analysis Set (FAS). 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015|||Percentage of patients with death|||Number
1399079|NCT01271712|Primary|Progression-free Survival|Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.|From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)|Full Analysis Set (FAS) - defined as all randomized participants.|||Days||95% Confidence Interval|Median
1399080|NCT01271686|Primary|Nocturnal Intraocular Pressure (IOP) Change|Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.|4 weeks||||mmHg||Standard Deviation|Mean
1399081|NCT01271543|Secondary|Time to Complete Laryngoscopy and Successful Intubation||Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.||||seconds||Standard Deviation|Mean
1399082|NCT01271543|Primary|Heart Rate and Blood Pressure Double Product|The double product was measured. The double product is calculated by multiplying the heart rate with the systolic blood pressure. It is also known as the rate pressure product and it is used to measure hemodynamic response.The double product is calculated from the values obtained preinduction, during intubation and after intubation.(5 minutes after intubation)The double products from each time point are averaged to get one mean double product value.|Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation.|double product (DP) of systolic blood pressure multiplied by heart rate|||(beats/minute)*mmHg||Standard Deviation|Mean
1399083|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.|||Number of Subjects|||Number
1399084|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.|||Number of Subjects|||Number
1399085|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.|||Number of Subjects|||Number
1399086|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 28 Based on the Subject's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 28 based on the subject’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|ITT: all randomized subjects.|||Number of Subjects|||Number
1399087|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 112 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 112 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 112|ITT: all randomized subjects.|||Number of Subjects|||Number
1399088|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 98 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 98 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 98|ITT: all randomized subjects.|||Number of Subjects|||Number
1399089|NCT01271452|Secondary|Number of Subjects With a Treatment Response at Day 84 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the FWS|Number of subjects with a treatment response at Day 84 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 84|ITT: all randomized subjects.|||Number of Subjects|||Number
1399090|NCT01271452|Primary|Number of Subjects With a Treatment Response at Day 28 Based on the Injector's Assessment of the Severity of Glabellar Lines at Maximum Contraction Using the Facial Wrinkle Scale (FWS)|Number of subjects with a treatment response at Day 28 based on the injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS. The FWS measures wrinkles on a scale from 0=none (best) to 3=severe (worst). Treatment response was defined as a 1 point or greater reduction from Day 0 in the FWS score at maximum contraction.|Day 28|Intent-to-treat (ITT): all randomized subjects.|||Number of Subjects|||Number
1399091|NCT01271413|Secondary|Digit Symbol Substitution Test||baseline, 7 weeks|||||||
1399092|NCT01271413|Secondary|Delay Discounting||baseline, 7 weeks|||||||
1399093|NCT01271413|Secondary|Addiction Severity Index||baseline, 7 weeks|||||||
1399094|NCT01271413|Secondary|go/No-go||baseline, 7 weeks|||||||
1399095|NCT01271413|Secondary|Trail-making||baseline, 7 weeks|||||||
1399096|NCT01271413|Secondary|Episodic Memory||baseline, 7 weeks|||||||
1399097|NCT01271413|Primary|Working Memory|Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks|baseline, 7 weeks||||digits recalled||Standard Deviation|Mean
1399098|NCT01271244|Primary|To Investigate the Effects of Escitalopram on an Absolute or Relative Decrease in Cardiac Sympathetic Function and Serious Cardiac Side Effects as Measured by QT Interval Variability in OEF/OIF Veterans With PTSD.||12 weeks|||||||
1399099|NCT01271244|Primary|1.To Investigate the Effects of Escitalopram on Cardiac Vagal Function as Measured by R-R Interval Variability, Especially in the HF (0.15-0.5 Hz) Band in OEF/OIF Veterans With PTSD.||12 Weeks||||msec||Standard Deviation|Mean
1399134|NCT01270958|Primary|Red Blood Cell Count at Baseline and After Treatment Completion|Red blood cells are cells in the blood that are used to transport oxygen throughout the body. Normal range: 3.9-5.8 10^12 cells per liter (Tetra/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||Tetra/L||Standard Deviation|Mean
1399100|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
1399101|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Neck Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
1399102|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 2|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
1399103|NCT01271036|Secondary|Number of Participants Reporting Subjective Irritation - Genital Application 1|Participants were asked to rate specific sensations they experienced during each application at each site (genital and neck) on a five-point categorical severity scale from mild to excruciating. The sensations included itching, burning, stinging, tingling, warming, and cooling. The number of participants with subjective irritation scores after one week was recorded.|One week|Full Analysis Set|||Participants|||Number
1399104|NCT01271036|Primary|Number of Participants With Physical Irritation Scores|Severity of physical irritation scored by the Investigator on a scale from 0 (no irritation) to 6 (presence of lesions). Since a score of 0 is required at baseline for inclusion in the study, this any score represents a change from baseline and the trial is considered baseline-controlled. The number of participants with physical irritation scores after one week was recorded (along with categorical severity).|One week|Full Analysis Set|||Participants|||Number
1399105|NCT01271010|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs|An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.|Up to approximately 5 years|All enrolled participants.|||percentage of participants|||Number
1399106|NCT01271010|Primary|Percentage of Participants With Phenotypic Remission|Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1399107|NCT01271010|Primary|Overall Survival|Overall survival was defined as the time period from the first day of study treatment to participant death.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1399108|NCT01271010|Primary|Event-free Survival|Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1399109|NCT01271010|Primary|Progression-free Survival|Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1399110|NCT01271010|Primary|Duration of Response|Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|Enrolled participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1399111|NCT01271010|Primary|Percentage of Participants With Partial Remission|Partial remission was defined as a reduction in tumor size by >50%.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1399112|NCT01271010|Primary|Percentage of Participants With Stable Disease|Stable disease was defined as not meeting the criteria for partial remission or disease progression|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1399113|NCT01271010|Primary|Percentage of Participants With Disease Progression|Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1399114|NCT01271010|Primary|Percentage of Participants With Complete Remission|Complete remission was defined as the disappearance of all signs of disease.|Up to approximately 5 years|All enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1402968|NCT01238588|Secondary|Albumin Levels||Baseline and 6 months|Clinical lab data for this outcome measure was not collected from the medical record (for research purpose) due to early termination of the study (per funding source)||||||
1399116|NCT01270971|Secondary|Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1399117|NCT01270971|Secondary|Completely Clear or Almost Clear Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.|Week 52|Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1399118|NCT01270971|Primary|Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52|No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.|Week 52|Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.|||participants|||Number
1399119|NCT01270958|Primary|Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion|Nasal polyps are non cancerous growths occurring in the nose or sinuses. Nasal ulcers are a break in skin or mucous membrane with loss of surface tissue, disintegration and necrosis of epithelial tissue.|Baseline and treatment completion (up to Week 6)|ITT Population|||percentage of participants|||Number
1399120|NCT01270958|Primary|Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion|The electrocardiogram is a recording of the electrical activity of the heart as it undergoes excitation (depolarization) and recovery (polarization) to initiate each beat of the heart. Normal ECG readings show a slight flat-dip in between contractions and relaxations. An abnormal ECG is determined by comparing the results of an ECG graph with a standard or normal heart graph. If these flat-dips are not present, it may be an indication of a more serious problem.|Baseline and treatment completion (up to Week 6)|ITT Population|||participants|||Number
1399121|NCT01270958|Primary|Albumin Value at Baseline and After Treatment Completion|Albumin is a simple water-soluble protein found in many tissues and liquids. Normal range: 35-50 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||g/L||Standard Deviation|Mean
1399122|NCT01270958|Primary|Total Protein Value at Baseline and After Treatment Completion|A total protein assay measures the amount of proteins found in the plasma. Normal range: 65-82 g/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||g/L||Standard Deviation|Mean
1399123|NCT01270958|Primary|Urea Nitrogen Value at Baseline and After Treatment Completion|The urea concentration of serum or plasma, conventionally specified in terms of nitrogen content and called blood urea nitrogen (BUN), is an important indicator of renal function. Normal range: 2.5-7.5 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
1399124|NCT01270958|Primary|Glucose Value at Baseline and After Treatment Completion|Glucose is a simple sugar used as a source of energy for cellular metabolism. Normal range: 3.9-6.4 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
1399125|NCT01270958|Primary|Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion|ALT is a liver enzyme that plays a role in protein metabolism. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs. Normal range: <=40 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||U/L||Standard Deviation|Mean
1399126|NCT01270958|Primary|Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion|AST is a liver enzyme released into the blood when certain organs or tissues, particularly the liver and heart, are injured. Normal range: <=37 U/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||U/L||Standard Deviation|Mean
1399127|NCT01270958|Primary|Alkaline Phosphatase Value at Baseline and After Treatment Completion|Alkaline phosphatase is an enzyme produced by the liver or bone. An elevated level of alkaline phosphatase in the blood may indicate a liver or bone problem. Normal range: 30-120 units per liter (U/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||U/L||Standard Deviation|Mean
1399128|NCT01270958|Primary|Creatinine Value at Baseline and After Treatment Completion|Creatinine is a metabolic waste product in urine that remains relatively constant in an individual and that may be used to establish baseline renal function. Normal range: 53-100 umol/L (female) and 62-120 umol/L (male).|Baseline and treatment completion (up to Week 6)|ITT Population|||umol/L||Standard Deviation|Mean
1399129|NCT01270958|Primary|Total Bilirubin Value at Baseline and After Treatment Completion|Total bilirubin is formed when hemoglobin breaks down. Bilirubin is excreted in bile and urine, and elevated levels may indicate certain diseases. Normal range: <=17 micromoles per liter (umol/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||umol/L||Standard Deviation|Mean
1399130|NCT01270958|Primary|Potassium Count at Baseline and After Treatment Completion|Potassium is the major positive ion (cation) found inside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 3.5-5.0 mmol/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
1399131|NCT01270958|Primary|Sodium Count at Baseline and After Treatment Completion|Sodium is the major positive ion (cation) found outside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 135-145 millimoles per liter (mmol/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||mmol/L||Standard Deviation|Mean
1399132|NCT01270958|Primary|Platelet Count at Baseline and After Treatment Completion|Platelets are cells found in the blood that play a role in blood clotting. Normal range: 150-400 Giga/L.|Baseline and treatment completion (up to Week 6)|ITT Population|||Giga/L||Standard Deviation|Mean
1399135|NCT01270958|Primary|Hematocrit Values at Baseline and After Treatment Completion|Hematocrit is the proportion of blood volume that is occupied by red blood cells. The hematocrit (Hct) is expressed as liter of red blood cells in liters of blood. Normal range: 0.35-0.50 Liter/Liter.|Baseline and treatment completion (up to Week 6)|ITT Population|||Liter/Liter||Standard Deviation|Mean
1399136|NCT01270958|Primary|Hemoglobin Values at Baseline and After Treatment Completion|Hemoglobin functions primarily to transport oxygen from the lungs to the body tissues. Normal range: 125-160 grams per liter (g/L).|Baseline and treatment completion (up to Week 6)|ITT Population|||g/L||Standard Deviation|Mean
1399137|NCT01270958|Primary|Heart Rate at Screening/Visit 1, Visit 2, and Visit 3|Heart rate is measured as the number of heart beats per unit time.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population|||beats per minute (bpm)||Standard Deviation|Mean
1399138|NCT01270958|Primary|Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|ITT Population: Some participants were lost to follow-up and may not have been dosed with study drug.|||mmHg||Standard Deviation|Mean
1399139|NCT01270958|Primary|Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3|Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure.|Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug. Some participants were lost to follow-up and may not have been dosed with study drug.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1399140|NCT01270919|Secondary|To Evaluate the Change in Outcomes From the Preoperative Time Point to Postoperative Time Points in Cases Implanted With the BioDuct® Meniscal Repair Device Using the SF-12, VAS Pain, WOMET and IKDC Subjective Knee Evaluation.||Postoperative compared to preoperative|||||||
1399141|NCT01270919|Primary|To Demonstrate Repair of the Meniscus 6 Months Post-implantation of the BioDuct® Meniscal Repair Device, Utilizing MRI. To Evaluate Clinical Success Using Postoperative Qualitative Criteria, as Compared to Preoperative Findings.||2 years|||||||
1399142|NCT01270880|Secondary|Potential Markers for Predicting Drug Response or Efficacy||At baseline, day 1 of course 3, and end of treatment|||||||
1399143|NCT01270880|Secondary|Association of PFS and PSA Response Rate With Primary and Secondary Target Markers||At 6 months|||||||
1399144|NCT01270880|Secondary|OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy||From first dose to death or the date last known alive|||||||
1399145|NCT01270880|Secondary|Overall Safety and Tolerability of STA-9090||Day 1, 8, and 15 of each course and at end of treatment|||||||
1399146|NCT01270880|Secondary|Percentage Change in PSA||From baseline to 12 weeks|||||||
1399147|NCT01270880|Primary|PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy|Defined as the time from first dose until the patient demonstrates disease progression based on PSA changes, discontinues STA-9090 therapy (for any reason), or expires (from any cause), whichever occurs first. Estimated with the standard Kaplan-Meier (K-M) method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived.|At 6 months||||months||90% Confidence Interval|Median
1399148|NCT01270867|Secondary|Secondary Endpoint|Incidence of asymptomatic intracranial hemorrhages (ICH) within 24 (-6/+12) hours post procedure|24 hours||||participants|||Number
1399149|NCT01270867|Secondary|Secondary Endpoint|All cause mortality at 90 days|procedure through 90 days||||participants|||Number
1399150|NCT01270867|Secondary|Secondary Endpoint|"Good clinical outcomes at 90 days, as assessed by mRS (a good clinical outcome is defined as mRS </= 2)~mRS 0-2 indicates functional independence 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead. https://en.wikipedia.org/wiki/Modified_Rankin_Sca"|90 days||||participants|||Number
1399151|NCT01270867|Primary|Primary Safety Endpoint|Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours).|within 24 hours of procedure||||participants|||Number
1399152|NCT01270867|Primary|Primary Efficacy Endpoint|"Revascularization of the occluded territory, defined as at least TICI 2 flow in the treated territory after use of the assigned device.~Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.~Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...~Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|acute/procedural|Intent to treat analysis was performed. The non-inferiority hypothesis was tested with Blackwelder's method, assuming a one-sided alpha=0.025 and a clinically relevant non-inferiority margin of 10%.|||participants|||Number
1399153|NCT01270841|Secondary|Reproductive Safety|Change from baseline in sperm concentration|3 months|Subjects with end of study assessments|||millions/mL||Standard Deviation|Mean
1399154|NCT01270841|Secondary|Change in FSH After 3 Months of Treatment||3 months|ITT population|||mIU/mL||Standard Deviation|Mean
1399155|NCT01270841|Secondary|Change in Luteinizing Hormone Levels|Changes in values from baseline in LH at month 3|3 months|ITT population|||mIU/mL||Standard Deviation|Mean
1402969|NCT01238588|Primary|Changes in Interleukin-6 (IL-6) Level||Baseline and 6 months|Blood samples were collected but the measurements were not done due to early study termination (per funding source).||||||
1399157|NCT01270828|Secondary|Percentage of Participants With Suicidal Behaviour/Ideation|Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.|Baseline, Weeks 6, 11, 15, 19 and 20|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
1399158|NCT01270828|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective severe to those AEs that interfere significantly with participant's usual function."|Baseline to Week 20|"The SB Analysis Set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.~Both SBAS and FAS were included in this analysis."|||Participants|||Number
1399159|NCT01270828|Secondary|Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)|The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
1399160|NCT01270828|Secondary|Change in the Brief Pain Inventory (BPI-sf)|The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
1399161|NCT01270828|Secondary|Change in Hospital Anxiety and Depression Scales (HADS)|The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
1399162|NCT01270828|Secondary|Change in Mean Daily Sleep Interference Scores|The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
1399163|NCT01270828|Secondary|Change in the Short Form 36 Health Survey (SF-36)|The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.|||Units on a scale||Standard Error|Least Squares Mean
1399164|NCT01270828|Secondary|Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score|The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.|Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
1399165|NCT01270828|Secondary|The MOS-SS-Optimal Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The percentage of participants with optimal sleep is presented here."|Week 6 and Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
1399231|NCT01270542|Secondary|Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.|Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3)|3 months from last surgery||||logMAR|Eyes|Full Range|Median
1399166|NCT01270828|Secondary|Change in the MOS-SS-Quantity of Sleep.|"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The item Quantity of sleep of MOS-SS is presented here."|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Hours||Standard Error|Least Squares Mean
1399167|NCT01270828|Secondary|Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).|The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.|SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified.|||Units on a scale||Standard Error|Least Squares Mean
1399168|NCT01270828|Secondary|Change in the Weekly NRS-Pain (1-Week Recall).|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week.|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
1399169|NCT01270828|Secondary|Change From Baseline to Endpoint in Weekly Mean Pain Score.|The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain|SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Units on a scale||Standard Error|Least Squares Mean
1399170|NCT01270828|Secondary|Percentage of Participants With 50% Reduction in the Mean Pain Score.|The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
1399171|NCT01270828|Secondary|Percentage of Participants With 30% Reduction in the Mean Pain Score.|The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Percentage of participants|||Number
1399172|NCT01270828|Secondary|Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results|"A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:~At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score~A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR."|13 Weeks|The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase|||Participants|||Number
1399173|NCT01270828|Primary|Number of Participants With Loss of Therapeutic Response.|Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.|13 Weeks|The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase.|||Participants|||Number
1399174|NCT01270802|Secondary|Change in Serum Levels of Vitamin D|Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body|Baseline and 24 weeks||||ng/mL||Standard Deviation|Mean
1399175|NCT01270802|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Change in FMD is a measure of change in endothelial function|Baseline and 24 weeks|In the Switch to tenofovir/emtricitabine plus raltegravir arm, two FMD measurements at 24 weeks were removed from the analysis due to poor quality imaging.|||% change from baseline||Standard Deviation|Mean
1399176|NCT01270711|Primary|Prevalence of Valvular Fibrosis|Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.|||percentage of participants|||Number
1399177|NCT01270711|Primary|Incidence of Valvular Fibrosis|Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.|Baseline (Week 1) up to Week 339|Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during study period.|||percentage of participants|||Number
1399178|NCT01270711|Primary|Total Number of Echocardiography Examinations in Cabergoline Users|The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.|Baseline (Week 1) up to Week 339|Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson’s disease during the study period.|||echocardiography examinations|||Number
1399179|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
1399180|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
1399181|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
1399182|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
1399183|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
1399184|NCT01270711|Primary|Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1|The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of prescriptions|||Number
1399185|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 6|Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson’s disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 6 (Year 2011)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
1399186|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 5|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 5 (Year 2010)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
1399187|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 4|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 4 (Year 2009)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
1399188|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 3|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 3 (Year 2008)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
1399189|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 2|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 2 (Year 2007)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
1399190|NCT01270711|Primary|Percentage of Second-line Prescriptions of Cabergoline for Parkinson’s Disease Indications: Year 1|Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson’s disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.|Year 1 (Year 2006)|Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson’s disease. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of prescriptions|||Number
1399191|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 6|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 6 (Year 2011)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
1399192|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 5|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 5 (Year 2010)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
1399193|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 4|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 4 (Year 2009)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
1399194|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 3|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 3 (Year 2008)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
1399195|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 2|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 2 (Year 2007)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
1402970|NCT01238588|Primary|Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level||Baseline and 6 months|Blood samples were collected but the measurements were not done due to early study termination (per funding source).||||||
1399196|NCT01270711|Primary|Number of Cabergoline Prescriptions by Database and Indication: Year 1|Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.|Year 1 (Year 2006)|Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||prescriptions|||Number
1399197|NCT01270659|Secondary|Number of Participants Experiencing Any Adverse Events|Occurrence of any adverse event.|Full 2 hours of the study period||||Participants|||Count of Participants
1399198|NCT01270659|Secondary|Nausea Level|"Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.~Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).~At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132)."|every 5 minutes for the first 60 minutes||||Participants|||Count of Participants
1399199|NCT01270659|Primary|Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)|Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).|60 minutes||||minutes||95% Confidence Interval|Median
1399200|NCT01270620|Secondary|Amount of Intraoperative Fentanyl||From the anesthesia induction until extubation||||micrograms||Inter-Quartile Range|Median
1399201|NCT01270620|Secondary|Duration of Anesthesia||Time from induction to extubation||||minutes||Inter-Quartile Range|Median
1399202|NCT01270620|Secondary|Duration of Surgery||Time from Incision to closure of surgery||||minutes||Inter-Quartile Range|Median
1399203|NCT01270620|Primary|Trail Making Part B|Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
1399204|NCT01270620|Primary|Trail Making Part B|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
1399205|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
1399206|NCT01270620|Primary|Trail Making Part A|• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
1399207|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
1399208|NCT01270620|Primary|Digit Symbol Substitution Test|• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
1399209|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 48 hours after surgery||||participants|||Number
1399210|NCT01270620|Primary|Recall of Digit Span|• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory|Change > 20% from baseline to 6-8 hours after surgery||||participants|||Number
1399211|NCT01270620|Secondary|ProBNP||Change from baseline to post-operative day 2||||ng/L||Inter-Quartile Range|Median
1399212|NCT01270620|Secondary|BNP||Change form baseline to post-operative day 2||||ng/L||Inter-Quartile Range|Median
1399213|NCT01270620|Secondary|Troponin I|Patients who had troponin level > 0.2 ng/mL|2 days||||participants|||Number
1399214|NCT01270620|Secondary|N-terminal proBNP||Change from baseline to day one||||ng/L||Inter-Quartile Range|Median
1399215|NCT01270620|Secondary|B-type Natriuretic Peptide||Change from Baseline to day one||||ng/L||Inter-Quartile Range|Median
1399216|NCT01270620|Secondary|Recovery Room Time||first day||||minutes||Inter-Quartile Range|Median
1399217|NCT01270620|Secondary|Nausea and Vomiting||48 hours||||participants|||Number
1399233|NCT01270542|Primary|The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR|Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.|3 months after last surgery||||pg/mL|Eyes|Full Range|Median
1399234|NCT01270529|Primary|Change in Physical Activity|Participants will measure physical activity in the form of daily steps using a pedometer|Baseline, 12 weeks||||change in steps per day||95% Confidence Interval|Mean
1399235|NCT01270503|Secondary|Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.|||Participants|||Number
1399236|NCT01270503|Primary|Safety Overview Within 30 Days in Participants Vaccinated With Menactra®||Day 0 up to Day 30 post-vaccination|Post-vaccination safety were assessed in the Safety Analysis Set.|||Participants|||Number
1399237|NCT01270464|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Week 8, Week 16, Endpoint, and Overall|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the two experimental treatment arms. Blood samples were collected for determination of ADAs before study drug infusion at baseline, visit 4 (week 8), and at visit 6 (week 16: EOT or early withdrawal) from patients in all 3 treatment groups (ie, placebo, 0.3 mg/kg reslizumab, and 3.0 mg/kg reslizumab); however, only the blood samples drawn from patients treated with either 0.3 mg/kg reslizumab or 3.0 mg/kg reslizumab were analyzed. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).~Endpoint =week 16 or early withdrawal."|Day 1 (pre-dose), week 8, 16 and endpoint|Pharmacokinetic analysis set. Anti-Reslizumab antibody status was not analyzed for patients in the Placebo treatment arm.|||participants|||Number
1399238|NCT01270464|Secondary|Shifts From Baseline to Endpoint in Electrocardiogram Findings|Participant counts in each category of shift from baseline to endpoint of ECG finding. Findings summarized as normal or abnormal.|Weeks -4 to -2 (Screening Visit), Week 16|Safety analysis set of participants with both baseline and endpoint values.|||participants|||Number
1399239|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Sitting pulse - high: >100 and increase of >= 30 beats/minute~Sitting pulse - low: <50 and decrease of >=30 beats/minute~Sitting diastolic blood pressure: >100 and increase of >=12 mmHg~Respiration rate: >24 and increase of >=10 breaths/minute~Body temperature: <96.5° Fahrenheit or <35.8° Celsius~The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set|||participants|||Number
1399240|NCT01270464|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology (except for eosinophil values), and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.~Total bilirubin: >=34.2 μmol/L~White blood cells: <=3.0 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 %~Platelets: >=700 10^9/L~Absolute neutrophil count: <=1.0 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline~The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29)."|Day 2 to Week 29|Safety analysis set|||participants|||Number
1399241|NCT01270464|Secondary|Participants With Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. The last postbaseline value for approximately 10 patients in each treatment group is the 90-day follow-up visit post end-of-treatment (approx. Week 29).|Day 1 (post-dose) to Week 29|Safety analysis set|||participants|||Number
1399242|NCT01270464|Secondary|Change From Baseline in Blood Eosinophil Count Over 16 Weeks Using Mixed Model for Repeated Measures|"Blood eosinophil counts were measured using a standard complete blood count (CBC) with differential blood test at each scheduled visit, and from all patients experiencing a serious adverse event, an adverse event leading to withdrawal, or an exacerbation of asthma symptoms. The during treatment (weeks 4, 8, 12 and 16) average eosinophil counts were estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline values correlate to reduced asthma severity."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.|||10^9 blood eosinophil/L||Standard Error|Least Squares Mean
1399243|NCT01270464|Secondary|Change From Baseline in Short-Acting Beta-Agonist (SABA) Use Over 16 Weeks Using Mixed Model for Repeated Measures|"SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit patients were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.~The during treatment (weeks 4, 8, 12 and 16) average SABA use was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.|||SABA puffs per day||Standard Error|Least Squares Mean
1399244|NCT01270464|Secondary|Change From Baseline in Asthma Symptom Utility Index (ASUI) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control. The during treatment (weeks 4, 8, 12 and 16) average ASUI was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline values indicate improvement in asthma symptoms. Information was obtained from questionnaire about asthma symptoms."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including patients who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
1399245|NCT01270464|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 16 or at Last Observed Value|"The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were “patient-specific,” which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.~Positive change from baseline scores indicate improvement in quality of life. The AQLQ score was only assessed once during the study at week 16 or at early withdrawal, i.e. last postbaseline assessment if within 3 to 5 weeks of the last dose of study drug."|Day 1 (baseline, pre-dose), Week 16 or last observed value|Full analysis set of participants with assessments at stated timeframes.|||units on a scale||Standard Error|Least Squares Mean
1399246|NCT01270464|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient’s FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control. The during treatment (weeks 4, 8, 12 and 16) average ACQ was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Negative change from baseline scores indicate improvement in asthma control."|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set, including participants who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
1399247|NCT01270464|Secondary|Change From Baseline in % Predicted Expiratory Volume In 1 Second (FEV1) at Week 16 and at Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Endpoint =week 16 or early withdrawal.|Day 1 (baseline, pre-dose), Week 16, endpoint|Full analysis set of participants with assessments at stated timeframes.|||percentage of predicted FEV1||Standard Deviation|Mean
1399248|NCT01270464|Secondary|Change From Baseline in Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) Over 16 Weeks Using Mixed Model for Repeated Measures|The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC). The during treatment (weeks 4, 8, 12 and 16) average FEF 25%-75% was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.|||liters/second||Standard Error|Least Squares Mean
1399249|NCT01270464|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Over 16 Weeks Using Mixed Model for Repeated Measures|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. The during treatment (weeks 4, 8, 12 and 16) average FVC was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|Day 1 (baseline, pre-dose), Weeks 4, 8, 12, 16|Full analysis set. Number of participants analyzed includes those who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
1399250|NCT01270464|Primary|Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer. The during treatment (weeks 4, 8, 12 and 16) average FEV1 was estimated using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.~Positive change from baseline scores indicate improvement in asthma control."|Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16|Full analysis set-all patients randomly assigned to treatment and treated with at least 1 dose of study drug. Number of participants analyzed includes those who contributed at least once to the analysis.|||liters||Standard Error|Least Squares Mean
1399251|NCT01270256|Primary|Change in Nasal Peak Inspiratory Flow (NPIF)|NPIF was measured objectively in liters per minute with an In-Check Peak & Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated|Baseline and 26 days||||liters/min||Standard Error|Median
1399283|NCT01269918|Primary|Total Opioid Consumption|Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.|Initial 90 minutes of recover after surgery||||mg morphine equivalents||Inter-Quartile Range|Median
1399252|NCT01270139|Secondary|Mean Number of Membrane Defects on Membrane of Red Blood Cells|Mean number of membrane defects on membrane of red blood cells calculated with atomic force microscopy (AFM) in random patients. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The analysis was undergone in eligible random evaluable patients. Only one random patient with exposure of gold nanoparticles was selected for a trial-balloon analysis of cytotoxicity. The blood was collected and split blindly into two ex-vivo experiments with AFM microscopy (see description).|||Mean number of membrane defects per cell|Area of blood sample per patient||Number
1399253|NCT01270139|Secondary|TVR (Target Vessel Revascularization)|TVR (target vessel revascularization) reflects per cent of patients with TVR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.|||Participants|||Count of Participants
1399254|NCT01270139|Secondary|TLR (Target Lesion Revascularization)|TLR (target lesion revascularization) reflects per cent of patients with TLR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.|||Participants|||Count of Participants
1399255|NCT01270139|Secondary|Cardiac Death|Cardiac death includes per cent of patients passed away due to any cardiac death. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The per-treatment-evaluable analysis was performed at 60 months.|||Participants|||Count of Participants
1399256|NCT01270139|Secondary|MACE|MACE includes per cent of patients with cardiac death. STEMI (ST-elevation myocardial infarction), non-STEMI, and TLR (target lesion revascularization). An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|The intention-to-treat analysis was performed at 60 months.|||Percentage of participants with MACE|||Number
1399257|NCT01270139|Secondary|Minimal Lumen Diameter|Minimal lumen diameter (MLD, mm)|at 12-month follow-up|The intention-to-treat analysis|||mm||Standard Deviation|Mean
1399258|NCT01270139|Secondary|Per Cent of Calcium|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
1399259|NCT01270139|Secondary|Per Cent of Necrotic Core|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
1399260|NCT01270139|Secondary|Per Cent of Fibrous Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core – red; dense calcium – white; fibrous – green; and fibro-fatty – light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
1399261|NCT01270139|Secondary|Target Lesion Revascularization|Target lesion revascularization, per cent|at 12-month follow-up|The intention-to-treat analysis|||Percentage of participants|||Number
1399262|NCT01270139|Secondary|Per Cent Atheroma Volume|Per cent atheroma volume (PAV, plaque burden, %). Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
1399263|NCT01270139|Secondary|Coronary Vasomotion - Mean Lumen Diameter After Infusion of Acetylcholine 10-6 M|Coronary vasomotion was assessed with QCA. End-diastolic images of coronary arteries were evaluated at baseline, after intravascular infusion of acetylcholine (through a microcatheter at increasing doses up to 10-8, 10-7, 10-6 M with a washout period of at least five minutes between each dose), and after nitroglycerine application following acetylcholine (100 µg orally). In all patients, measurements were performed in two segments on site of intervention while 960 seconds. The artery diameter was calibrated against the contrast-filled tip of the catheter. Vasoconstriction to acetylcholine was defined as a 3% change of the mean lumen diameter after infusion of the maximal dose of acetylcholine. An investigator blinded to treatment group performed all measurements.|at 12-month follow-up|The intention-to-treat analysis|||mm||Standard Deviation|Mean
1399264|NCT01270139|Secondary|Late Definite Thrombosis|Late definite thrombosis rate|at 12-month follow-up|The intention-to-treat analysis|||Percentage of participants|||Number
1399265|NCT01270139|Secondary|Restenosis Rate|Restenosis (stenosis>50%) rate|at 12-month follow-up|The intention-to-treat analysis|||Percentage of patients|||Number
1399266|NCT01270139|Secondary|Event Free Survival|The Kaplan-Meier analysis of the cardiac event-free survival (failure-free survival). The end point in this study was cardiac event-free survival during follow-up, starting at randomization. Cardiac events included cardiac death, myocardial infarction and unintended revascularization. Cardiac death was defined as sudden death, death after the onset of symptoms suggestive of cardiac ischemia and death due to heart failure. Noncardiac death was defined as death due to all other causes. Myocardial infarction was defined as an increase in cardiac enzymes or new pathologic Q-waves on the ECG, or both. Unintended revascularization was defined as PTCA or CABG performed due to worsening of the patient’s clinical condition, rather than the PTCA or CABG assigned by the revascularization team when patient management was determined.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of survived patients|||Number
1399267|NCT01270139|Secondary|Per Cent of Fibro-fatty Component|IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.|at 12-month follow-up|The intention-to-treat analysis|||Percentage of tissue||Standard Deviation|Mean
1399268|NCT01270139|Primary|MACE (Major Adverse Cardiovascular Events)-Free Survival|MACE (major adverse cardiovascular events)-free survival reflects per cent of survived patients without MACE. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.|at 60 months follow-up|Some patients were lost to follow-up at 5 years and were not included to the final analysis. The intention-to-treat analysis was performed at 60 months.|||Percentage of survivors without MACE|||Number
1399269|NCT01270139|Primary|Total Atheroma Volume|Total atheroma volume (TAV, plaque-media volume, mm3) at 12 months. Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.|at 12-month follow-up|The intention-to-treat-population analysis|||mm3||Standard Deviation|Mean
1399270|NCT01270126|Secondary|Other Visual and EEG Parameters|Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.|Nov 2006 - Dec 2010|||||||
1399271|NCT01270126|Primary|Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors|Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.|Initial diagnostics (baseline), Post diagnostics||||percent change||Standard Deviation|Mean
1399272|NCT01269918|Secondary|Postoperative Shivering|Indicator of whether patients had postoperative shivering.|Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.||||participants|||Number
1399273|NCT01269918|Secondary|Postoperative Vomitting|Indicator of whether patients had postoperative vomiting.|Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.||||participants|||Number
1399274|NCT01269918|Secondary|Postoperative Nausea|Indicator of whether patients had nausea or not|Whether patients had nausea or not, from anesthesia stop time until hospital discharge.||||participants|||Number
1399275|NCT01269918|Secondary|End Case to Post Anesthesia Care Unit (PACU) Discharge|Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.|End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.||||minutes||Inter-Quartile Range|Median
1399276|NCT01269918|Secondary|Drug Stop Time to Fitness to Discharge||Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.||||minutes||Inter-Quartile Range|Median
1399277|NCT01269918|Secondary|Drug Stop Time to Recall|Time between extubation until patients could say their names.|Time between extubation until patients could say their names.||||minutes||Inter-Quartile Range|Median
1399278|NCT01269918|Secondary|Drug Stop Time to Open Eyes|time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery|Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.||||minutes||Inter-Quartile Range|Median
1399279|NCT01269918|Secondary|Nursing Workload Comparison|To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).|90 minutes after extubation||||units on a scale||Inter-Quartile Range|Median
1399280|NCT01269918|Secondary|Aldrete Score|The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.||||units on a scale||Standard Deviation|Mean
1399281|NCT01269918|Secondary|Modified Short Orientation Memory Concentration Test (SOMCT)|The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.|15, 30, 45, 60, and 90 minutes after extubation.||||units on a scale||Standard Deviation|Mean
1399284|NCT01269918|Primary|Postoperative Pain|Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.||||units on a scale||Standard Deviation|Mean
1399285|NCT01269918|Primary|Hemodynamics|Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.|15, 30, 45, 60, and 90 minutes after extubation.||||mmHg||Standard Deviation|Mean
1399286|NCT01269801|Primary|Efficacy|"Assessments at Visits 3,5,6+7 (weeks 4,8,12,24) include:~-Physician Global Aesthetic Improvement Scale (PGAIS). Ratings include no change, improved, much improved, very much improved.~Number of subjects with improvement score for the 5 point PGAIS from baseline to Visit 7.~-Objective Observer Global Aesthetic Improvement Scale Number of subjects with improvement score for the from baseline to Visit 7. Ratings include no change, some improvement, definite improvement, substantial improvement, and complete improvement."|Week 4, 8, 12, 24|Analysis is based on the randomization group to account for the order in which the products were administered.|||participantes rated improved and higher|||Number
1399287|NCT01269749|Secondary|Cancer Risk Assessment|Secondary Aims. (i) As a follow-up to the first primary aim, we will calculate potential cancer risk from the radiation exposure data; and (ii) within the analyses for the second primary aim, we will evaluate chromosomal translocation in children treated with 131I vs. not, as related to age and dose of 131I.|4 years|Data was not collected||||||
1399288|NCT01269749|Primary|Dosimetry Studies|Primary Aims. We propose to (1) perform dosimetry to assess whole body radiation exposure following 131II therapy in children treated for GD; and (2) assess the effects of 131I treatment of GD (treated with medication or surgery) on chromosome translocations.|4 years|Data was not collected||||||
1399289|NCT01269736|Secondary|Patient Outcomes|Mortality, in-hospital MI, and not surviving a cardiac arrest were obtained using administrative data and laboratory data (eg, troponin, CK-MB) for all patients. Mortality was defined as death that occurred on one of the participating units. To identify the occurrence of in-hospital MI, laboratory data, timing of procedures, and location of patient at the time of the first blood draw indicating the event were used. Cardiac arrest was defined as an event initiated by an arrhythmia that required immediate intervention and was initiated on a PULSE participating unit. For each qualifying cardiac arrest, it was determined whether the patient survived the event.|Baseline, 15 months, 30 months|The overall number of unique patients reviewed at any timepoint. The numbers presented at each time point reflect the number of people reviewed at that time point for that outcome.|||Participants|||Count of Participants
1399290|NCT01269736|Secondary|Quality of Patient Care Related to ECG Monitoring|Percentage of patients with accurate electrode placement, accurate rhythm interpretation, cardiac arrest, cardiac arrest initiated by arrhythmia, appropriate monitoring, telemetry units only, ST-segment monitoring when indicated, and QTc measurement when indicated|Baseline, 15 months, 30 months|The overall number of unique patients assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point.|||Participants|||Count of Participants
1399291|NCT01269736|Primary|Nurses' Knowledge and Skills Related to ECG Monitoring|Participants took a 20-item online test on essentials of ECG monitoring, and arrhythmia, ischemia, and QT interval monitoring. Scores represent the percentage of correct answers. (Test scores range from 0 to 100 with higher scores representing more correct answers)|Baseline, 15 months, 30 months|The overall number of unique nurses assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point.|||percentage of items correctly answered||Standard Deviation|Mean
1399292|NCT01269710|Secondary|Change in LDL (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
1399293|NCT01269710|Secondary|Change in Triglycerides (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
1399294|NCT01269710|Secondary|Change in Total Cholesterol (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
1399295|NCT01269710|Secondary|Change in Glucose Levels (mg/dL)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||mg/dL||Standard Deviation|Mean
1399361|NCT01268111|Primary|M Value (Insulin Stimulated Glucose Uptake)|Insulin stimulated glucose uptake will be measured by glucose clamp studies|Baseline and at 8 weeks||||mg/kg.min||Standard Deviation|Mean
1399296|NCT01269710|Primary|Change in Weight (in Lbs.)|"Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with second-generation antipsychotics (SGA's) during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12 (Week 52).~Since only a single participant finished the study and had assessments through Week 52, we compiled the data from all subject endpoints (1 Week 12 visit, 2 Week 36 visits, and 1 Week 52 visit) and this is the data reported below."|Baseline and 52 Weeks|All four enrolled study participants were included in this analysis.|||lbs.||Standard Deviation|Mean
1399297|NCT01269346|Secondary|Duration of Stable Disease (SD)|Defined as the period from treatment start date to the date of PD or death, whichever occurred first. Participants who were alive without having PD as of the data cutoff date were censored as of their last tumor assessment. Calculated for participants who best response was SD.|Start of study treatment to date of PD or death, whichever occurred first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1399298|NCT01269346|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment.|Date of first dose of study drug to date of PD or death (from any cause) whichever came first, or date of data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1399299|NCT01269346|Secondary|Duration of Response (DOR)|Duration of response was defined for participants whose best overall response was CR or PR. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were alive at the end of the study without reported PD were censored on the date of their last tumor assessment.|Date of a confirmed CR or PR was first documented to the date of PD or death (due to any cause and in the absence of PD), whichever occurred first, or date of data cutoff (12 Sep 2013), or up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug. Analyzed for responders only (n = 37).|||Months||95% Confidence Interval|Median
1399300|NCT01269346|Secondary|Time to First Response|Time to first response was defined for participants whose best overall response was a CR or PR.|From date of first dose of study drug to the earliest date that CR or PR was objectively documented, assessed up to data cutoff (12 Sep 2013), up to approximately 2 years 9 months|FAS included all participants who received at least one dose of study drug. Analyzed for responders (CR or PR) only.|||Months||95% Confidence Interval|Median
1399301|NCT01269346|Primary|Objective Response Rate|The Objective Response Rate (Complete Response plus Partial Response, (CR + PR)) was defined as the proportion of participants who have a best overall response of confirmed CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator. Tumor assessment was by computed tomography (CT)/magnetic resonance imaging (MRI). To assess best response (CR, PR, stable disease (SD), progressive disease (PD), or not estimable (NE)), the Investigator selected up to five measurable target lesions (2 per organ). All other lesions were identified as nontarget lesions. Each participant’s overall tumor burden at Baseline was compared with subsequent measurements of the target lesions. For participants with CR or PR, changes in tumor sizes had to be confirmed by repeat evaluations performed not fewer than four weeks after the initial response assessment.|Baseline (within 28 days of first infusion of study drug); Treatment Phase (every 6 weeks during the first 6 cycles); Extension Phase (every 12 weeks) to PR or CR|FAS included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1399302|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy rate was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|4 weeks after a positive pregnancy test|In order to handle the problem of small sample size bootstrap techniques are used. Ader et al recommend bootstrap procedures(a) distribution is complicated or unknown, (b) a small sample is available. Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.|||Percentage||95% Confidence Interval|Mean
1399303|NCT01269125|Secondary|Follicular Fluid's TNF-a Concentration.|TNF-a was measured in the FF of all women (secondary outcome measures). To prevent any cytokine alterations, only blood-free samples were used.|June 2004-August 2010||||pg/ml||Standard Deviation|Mean
1399304|NCT01269125|Primary|Fertilization Rate (Percentage of Fertilized Oocytes).|The fertilization rate was estimated for every woman 24 hours after oocyte retrieval|June 2004-August 2010||||percentage||95% Confidence Interval|Mean
1399305|NCT01269125|Primary|Embryo Quality (the Percentage of Grade 1 Embryos Per Participant).|Embryo development was evaluated 2 days after oocyte pick-up. The number of blastomeres and the proportion of embryo volume occupied by fragments were used for the evaluation. Embryos with < 10%, < 10-20%, < 20-30% and >30% fragments were estimated as grade 1,2,3 and 4, respectively.|June 2004-August 2010||||Percentage of grade 1 embryos||95% Confidence Interval|Mean
1399306|NCT01269125|Primary|Clinical Pregnancy Rate|Clinical pregnancy was confirmed by observing fetal cardiac activity on transvaginal ultrasound four weeks after a positive pregnancy test.|June 2004-August 2010|The study period was seven years. Practical issues such as, no more funds for measuring cytokines, my transportation to different University stopped this study before reaching adequate power. The flow of the participants in our Department was low.|||percentage||95% Confidence Interval|Mean
1399307|NCT01269047|Secondary|Difference in HbA1C Between the Treatment and the Control Groups||6 months||||percentage of HbA1C values||Standard Deviation|Mean
1399308|NCT01269047|Primary|Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus.|We measured post-prandial blood sugars in both pramlintide and exenatide treated groups in acute and chronic setting, when compared to insulin monotherapy in subjects with Type 1 Diabetes Mellitus|6 months||||mmol/L||Standard Deviation|Mean
1399419|NCT01267136|Secondary|Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.|Parent-reported side effects entered in 10-day diary.|Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.||||participants|||Number
1399309|NCT01268943|Primary|Dose Related Toxicity|dose related toxicity is defined as follows:1. WBC damage >= grade 3; granular cell decrease >= grade 3; hemoglobin >= grade 2; platelet >= grade 2;SGPT/SGOT elevation >= grade 2; ALP >= grade 2; GGT >= grade 2; Tbil >= grade 2;renal function damage: BUN/Cr elevation >= grade 2;Non-gradular cell decreased fever >= grade 2;nausea/vomiting >= grade 2; fatigue >= grade 3; weight loss >= grade 3;gastritis >= grade 3; dairrea >= grade 3; abdominal pain >= grade 3; pancreatitis >= grade 2; upper gastrointestinal bleeding >= grade 2;other toxic reaction >= grade 3;KPS < 50 during the treatment|up to 9 weeks||||event|||Number
1399310|NCT01268891|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson’s Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF|||units on a scale||Standard Error|Mean
1399311|NCT01268891|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worst outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 18|FAS; LOCF|||units on a scale||Standard Error|Mean
1399312|NCT01268891|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 18|FAS; last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
1399313|NCT01268891|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson’s Disease Patient Diary|"Parkinson’s Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.~The Change From Baseline in Mean Total Daily OFF Time is calculated by taking the difference between the average of the total daily OFF time at Weeks 6, 10, 14 and 18, and the Baseline Total Daily OFF Time."|Baseline and Weeks 6, 10, 14, and 18|Full-analysis set (FAS); observed cases (OC)|||hours||Standard Error|Mean
1399314|NCT01268683|Secondary|Clinical and MRI Outcome Data|The proportion of subjects with mRS <=4 expressed as a % (total number of patients with mRS <=4 divided by total number of patients enrolled).|90 days||||percentage of participants|||Number
1399315|NCT01268683|Secondary|Pharmacokinetics/Pharmacodynamics|The number of patients with unanticipated PK or PD responses was assessed. An unanticipated PK or PD response would have been, for instance, a peak concentration inconsistent with prior PK assessments, or an unexpectedly low blood glucose level (< 40 mg/dL)|3 days||||participants|||Number
1399316|NCT01268683|Secondary|Safety and Tolerability|"AE's of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all SAE's will be followed for 90 days.~SAE's and AE's were reviewed, and the number of subjects with unanticipated adverse events, or drug-related SAE's were assessed."|90 days||||participants|||Number
1399317|NCT01268683|Primary|Rate of Recruitment|The number of months it took to enroll the 10 patients|11 months||||months|||Number
1399318|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Vital Sign Parameters|Vital sign assessments were conducted throughout the study and included body temperature, blood pressure (seated), pulse rate and respiratory rate. The TEAEs related to vital signs in participants were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
1399319|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time period) and analyzed. Number of participants with TEAEs related to ECG after the start of study drug administration were reported. Participants were counted only once for each system organ class and preferred term, regardless of how many events the participants had.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
1399320|NCT01268566|Secondary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count with differential); serum chemistry (calcium, chloride, magnesium, potassium, sodium, aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma glutamyl transferase, lactic dehydrogenase, carbon dioxide/bicarbonate, blood urea nitrogen, uric acid, creatinine, total bilirubin, glucose, albumin, total protein, triglycerides, cholesterol, phosphorous); urinalysis (pH, protein, blood, glucose, ketones, bilirubin); and coagulation parameters. Abnormal laboratory finding that required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation, was reported as an AE. Number of participants with TEAEs related to laboratory evaluations were reported.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
1399363|NCT01268098|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.|The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1399321|NCT01268566|Secondary|Number of Participants With Worst ECOG Performance Status On-study and Last Record On-study|Eastern Cooperative Oncology Group (ECOG) performance status is a scale that measures how cancer affects the daily life of a participant on an ordinal scale from grade 0 (fully active ie, best) to 5 (dead ie, worst). Following are ECOG grades: 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead.|Baseline to last record on study, up to 21 months|Safety population|||Participants|||Number
1399322|NCT01268566|Secondary|Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are AEs occurring or worsening after the administration of study drug until 90 days after the last dose of study drug or until the participant began another anticancer therapy, which ever came first. A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. The TEAEs and SAEs were summarized using MedDRA version 15.1. Participants were counted only once for each event, regardless of number of events the participant had.|Baseline to last record on study, up to 21 months|Safety population included all participants who received at least 1 dose of MEDI-575.|||Participants|||Number
1399323|NCT01268566|Secondary|Percentage of Participants With Expression of PDGFR Alpha in the Tumor Samples|MEDI-575 (study drug) blocks platelet-derived growth factor (PDGF) binding to PDGF receptor (PDGFR) alpha and inhibits signaling. The tissue samples which were collected prior to the study entry (archived tumor samples) were evaluated by immunohistochemistry staining for expression of PDGFR alpha signaling protein that are targets of MEDI-575. Expression of PDGFR alpha in tumor cells and tumor-associated stromal cells were evaluated for intensity and distribution of staining. The percentage of participants with positive PDGFR alpha staining in the tumor cells and tumor-associated stromal cells were reported.|Screening (Day-28 to Day -1)|ITT population with archived tumor samples were assessed.|||Percentage of participants|||Number
1399324|NCT01268566|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, Overall survival was censored on the last date when participants were known to be alive. The Overall survival was estimated using the Kaplan-Meier method.|Study entry to death, up to 16 months|ITT population. N= number of participants analyzed for this outcome measure|||Months||90% Confidence Interval|Median
1399325|NCT01268566|Secondary|Progression-free Survival|PFS was measured from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Time to PFS was estimated using Kaplan-Meier method.|9 months|ITT population. N= number of participants analyzed for this outcome measure|||Months||90% Confidence Interval|Median
1399326|NCT01268566|Secondary|Progression-free Survival Rate at 3 Months and 9 Months|PFS rate at 3 and 9 months is defined as proportion of participants who neither progressed nor died due to any cause, whichever occurred first after first dose at 3 months and 9 months, respectively. Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. Proportion of participants with PFS at 3 and 9 months were estimated using Kaplan-Meier method.|3 months and 9 months|ITT population|||Percentage of participants||90% Confidence Interval|Number
1399327|NCT01268566|Secondary|Time to Progression|Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression was defined by at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/FLAIR nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. TTP was estimated using Kaplan-Meier method.|Study entry until the first documented disease progression, up to 16 months|ITT population. N= number of participants analyzed for this outcome measure|||Months||90% Confidence Interval|Median
1399328|NCT01268566|Secondary|Duration of Response|Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. Duration of response was estimated using Kaplan-Meier method and evaluated only for the participants of subgroup with an objective response.||ITT population with an objective response (ie, confirmed CR or PR) were assessed. Duration of response was not estimable as there were no participants with an objective response.||||||
1399329|NCT01268566|Secondary|Time to Response|Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was estimated using Kaplan-Meier method.||ITT population with an objective response (ie, confirmed CR or PR) were assessed. TTR was not estimable as there were no participants with an objective response.||||||
1399330|NCT01268566|Secondary|Percentage of Participants With Objective Response|Objective response rate (ORR) is defined as the proportion of participants with confirmed CR or confirmed PR using RANO criteria. Confirmed CR and PR are those that persist on repeat imaging study for at least 4 weeks after the initial documentation of the response. CR is defined as complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, patient is off corticosteroids and stable or improved clinically. PR is defined as 50% decrease compared with baseline in the measurement of all measurable enhancing lesions sustained for at least 4 weeks, no progression of nonmeasurable disease, no new lesions, stable or improved nonenhancing (T2/FLAIR) lesions, no increase in the corticosteroid dose and stable or improved clinically.|Study entry through the end of the study, up to 21 months|ITT population|||Percentage of participants||90% Confidence Interval|Number
1399331|NCT01268566|Secondary|Percentage of Participants With Best Overall Response|Best overall response rate is calculated based upon the disease assessments recorded during the study visits using RANO criteria. Best overall response includes complete response (CR), CR with confirmation, partial response (PR), PR with confirmation, stable disease and progressive disease. Confirmed responses are those that persist on repeat imaging studies at least 4 weeks after the initial documentation of response.|Study entry through the end of the study, up to 21 months|ITT population|||Percentage of participants|||Number
1399332|NCT01268566|Primary|Progression-free Survival Rate at 6 Months|Progression-free survival (PFS) rate at 6 months is defined as the proportion of participants who neither progressed nor died before 6 months after the first dose. Progression was determined using Updated Response Assessment Criteria of High Grade Gliomas: Response Assessment in Neuro-Oncology Working Group (RANO criteria). Progression was defined as at least 25% increase in measurement of enhancing lesions compared with the smallest tumor measurement obtained during the study; or significant increase in T2/fluid attenuated inversion recovery (FLAIR) nonenhancing lesion compared with baseline scan or best response; or any new lesion; or clear clinical deterioration; or failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease. PFS-6 was estimated using Kaplan-Meier method.|6 months|Intent-to treat (ITT) population: All participants who entered into the study (ie, participants for whom investigator notified the interactive web response system [IWRS] that the participant met eligibility criteria and the IWRS assigned unblinded study drug to the participant).|||Percentage of participants||90% Confidence Interval|Number
1399333|NCT01268553|Secondary|N-terminal Pro BNP Level|N-terminal pro BNP level|12 weeks||||pg/mL||Standard Deviation|Mean
1399334|NCT01268553|Secondary|CAMPHOR: Cambridge Pulmonary Hypertension Outcome Review; Construct = Quality of Life|The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a disease specific patient-reported outcome measure which assesses quality of life of patients with pulmonary hypertension (PH). QoL scores (total) range from 0-25, with higher scores indicating worse quality of life|12 q=weeks||||units on a scale||Standard Deviation|Mean
1399335|NCT01268553|Secondary|VE/VCO|Ventilatory efficiency measured with cardiopulmonary exercise testing|12 weeks||||ratio||Standard Deviation|Mean
1399336|NCT01268553|Secondary|Change in 6-minute Walk Distance|Change in 6-minute walk distance from baseline to 12 weeks.|12 weeks|Mean change in 6-minute walk distance|||meters||Standard Deviation|Mean
1399337|NCT01268553|Secondary|Number of Participants Without Clinical Worsening|"Clinical worsening is defined as any of the following:~All-cause mortality~Nonelective hospital stay for PAH (with predefined criteria, usually for initiation of intravenous prostanoids, lung transplantation, or septostomy)~Disease progression defined as a reduction from baseline in the 6MW test by 15%, confirmed by 2 studies done within 2 weeks plus worsening functional class"|12 weeks|Patients weaned off of their parenteral prostanoids without Clinical Worsening|||Participants|||Count of Participants
1399338|NCT01268553|Primary|Number of Participants Without Adverse Events|The number of adverse events will be recorded at transition, 4 weeks, and 12 weeks.|12 Weeks|Number of patients weaned off of their parenteral prostanoids without adverse events|||Participants|||Count of Participants
1399339|NCT01268501|Primary|Overall Convenience With Contact Lenses|"Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, very satisfied or satisfied."|3 weeks of wear|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review.|||Percentage of participants||95% Confidence Interval|Number
1399340|NCT01268488|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|158 BG results-78 subjects tested 2 strip lots;2 subjects tested 1 strip lot. 7 subjects-Low BG results disallowed forearm testing per protocol. 1 subject-Missing data. Remainder same as 'palm' analysis population description.|||Number of BG Test Results|Participants||Number
1399341|NCT01268488|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects(1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|97 participants analyzed: one subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated. For palm and forearm testing tasks, 2 additional subjects (with nonevaluable BG data) were not included. Only 95 participants were rated for those particular tasks.|||participants|||Number
1399378|NCT01267422|Secondary|Neutralizing Antibody Assay|The mean of Neutralizing antibody assay of 8 patients before and after treatment|up to 3 years|Neutralizing antibody assay of 8 patients except Patient 1 because he once accepted the other eye's treatment|||titer||Standard Deviation|Mean
1399342|NCT01268488|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|161 BG results-80 subjects tested 2 strip lots;1 subject had 1 reading. Withdrawn by PI- 3 subject Adverse Events before performance testing;1 subject did not meet inclusion/exclusion. 6 subjects- Data not evaluable:exceeded time between meter testing and reference method. 7 subjects-Low bg results disallowed palm testing per protocol.|||Number of BG Test Results|Participants||Number
1399343|NCT01268488|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|178 BG results possible-88 subjects tested 2 strip lots(88x2)/2 subjects had 1 reading(2x1). Withdrawn by Principal Investigator(PI)-3 subjects experienced Adverse Events before performance testing / one subject did not meet inclusion/exclusion. Data from 4 subjects were not evaluable since exceeded time between meter testing and reference method.|||Number of BG Test Results|Participants||Number
1399344|NCT01268306|Primary|Number of Participants Wiith Corneal Staining|The number of participants who have disturbance of their corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy. Clinically significant staining is described as sufficiently diffuse and deep to pose potential risk of infection by the examiners assessment.|2-4 hours after contact lens insertion|Subjects who returned for examination post-challenge in the allotted time and who had observable corneal staining on slit lamp examination|||participants|||Number
1399345|NCT01268293|Primary|Number of Participants With Adverse Events|Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events [CTCAE] version 4.0, laboratory tests, vital signs (blood pressure [mm Hg], heart rate [beats per minute], body temperature [degree C], and body weight [kg]), 12-lead electrocardiograms (ECGs; heart rate [bpm], QT [msec] and QTc [msec]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).|Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).|The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Number
1399346|NCT01268293|Primary|Number of Participants With Dose Limiting Toxicity (DLT)||Up to 4 weeks|Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.|||Participants|||Number
1399347|NCT01268267|Secondary|Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.|||Number of BG test results|Participants||Number
1399348|NCT01268267|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 participants were rated for those particular tasks.|||participants|||Number
1399349|NCT01268267|Secondary|Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.|||Number of BG test results|Participants||Number
1399362|NCT01268098|Secondary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data|8 Weeks|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1399350|NCT01268267|Primary|Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available.|||Number of BG test results|Participants||Number
1399351|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 12||||units on a scale||Standard Deviation|Mean
1399352|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 10||||units on a scale||Standard Deviation|Mean
1399353|NCT01268189|Secondary|Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site||Post-Operative Day 8||||units on a scale||Standard Deviation|Mean
1399354|NCT01268189|Secondary|Pain Perceived by Patient|Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.|Post-Operative Day 4||||units on a scale||Standard Deviation|Mean
1399355|NCT01268189|Primary|Healing Time for Donor Site Wounds|Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.|number of days to healing||||days||Standard Deviation|Mean
1399356|NCT01268150|Other Pre-specified|To Assess the Incidence of Adverse Events (AEs) of Eribulin Mesylate|Treatment-emergent adverse events (TEAEs) were defined as AEs that emerged during treatment, having been absent at pretreatment, and occurring within 30 days of the last dose of study treatment, or if they were present prior to the first dose administration and increased in severity during the study. For each AE a participant with two or more TEAEs in that category were counted only once. TEAEs were considered related if the relationship of the event to study drug was possibly or probably related. Serious adverse events (SAEs) were defined as any untoward medical experience that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. Safety information will be summarized with adverse events. AEs were graded on a five-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline until End of Treatment (within 21 days of last dose), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Safety Analysis Set population included all participants who received at least one dose of study drug and had at least one postbaseline safety assessment.|||Percentage of participants|||Number
1399357|NCT01268150|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment. Participants without evidence of PD upon discontinuation of study drug during the Extension Phase returned to the clinic for disease evaluation and PFS calculation every 12 weeks until PD was documented. PFS was analyzed using Kaplan-Meier product-limit estimates. This statistical analysis method measures the effect of study drug on PFS.|Treatment Phase (Day 1 Cycle 1) to date of progressive disease or death, whichever occurred first, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.|||Months||95% Confidence Interval|Median
1399358|NCT01268150|Secondary|Duration of Response|Duration of response was measured for participants who were responders only, had attained a BOR that was CR or PR. The duration of response was measured from time that response criteria for CR or PR (whichever was recorded first) were first met until the date that progressive disease (PD) or death from any cause was first objectively documented. Participants who did not have PD were censored on the day of their last tumor assessment. Duration of response was summarized for the responders using Kaplan-Meier estimation method. This statistical analysis method measures the effect of study drug on the length of response time.|First date of CR or PR to PD or Death from any cause, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.|||Months||95% Confidence Interval|Median
1399359|NCT01268150|Secondary|Time to First Response (CR or PR)|Time to first response was defined for participants whose BOR was a CR or PR. Analysis was based on the Kaplan-Meier estimated number of months to CR or PR. This statistical analysis method measures the effect of study drug on CR or PR.|Treatment Phase (Day 1 Cycle 1) to earliest date of confirmed objective response (CR or PR), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate and were determined to be responders (CR or PR) to study treatment.|||Months||95% Confidence Interval|Median
1399360|NCT01268150|Primary|Objective Response Rate (ORR)|The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR|Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years|Full analysis set included all participants who received at least one dose of eribulin mesylate.|||Percentage of participants|||Number
1399379|NCT01267422|Secondary|Intraocular Pressure;||Up to 3 years||||mmHg||Full Range|Mean
1399364|NCT01268046|Primary|Functional Magnetic Resonance Imaging (fMRI) Changes in Response to Estrogen and Aging - Dorsolateral Pre-frontal Cortex (DLPFC)|Change in extracted beta coefficients of the blood oxygen level dependent (BOLD) signal response to a cognitive task (N-back) in the DLPFC (x,y,z coordinates = -34 44 16) from baseline to 1 month as a function of aging and estrogen (young vs older and estrogen vs placebo). A positive change indicates an increase in oxygen utilization (inferring increased neuronal functioning) between baseline and treatment during the cognitive task, while a negative change indicates a decrease in oxygen utilization between baseline and treatment during the cognitive task.|baseline to 1 month|all young and older postmenopausal women who completed one month of placebo or estrogen and in whom structural and functional MRI data were of significant quality for analysis.|||linear beta extractions||Standard Error|Mean
1399365|NCT01267994|Secondary|Number of Serious Adverse Events Reported|To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra|84 days|Any subject enrolled in this study who received at least 1 injection dose of anakinra|||reported SAEs|||Number
1399366|NCT01267994|Primary|To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease|The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.|180 days||||responders|||Number
1399367|NCT01267929|Primary|The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.|The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates < 10% of activity,2=partially completes 10% to < 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.|Base line, two months and six months|A total of 30 children with cerebral palsy was followed and completed the study.|||Scores on a scale||Standard Deviation|Mean
1399368|NCT01267864|Secondary|Adverse Event|% who report any adverse event after administration of investigational medication|24 hours|Any adverse event reported at any assessment throughout the study period.|||Participants|||Count of Participants
1399369|NCT01267864|Secondary|Satisfaction With Medication|% who answer the following question affirmatively at 24 hours: Do you want to receive the same medication the next time you present to an ER with an acute migraine|24 hours|Study participants were telephoned 24 hours after medication administration. 3 patients in the metoclopramide arm, 4 in the ketorolac arm, and 3 in the valproate arm were lost to follow-up and did not provide these data. Additionally, 1 patient in the ketorolac arm did not provide an answer to this question|||Participants|||Count of Participants
1399370|NCT01267864|Secondary|Participants Who Achieve Sustained Headache Freedom for 24 Hours|Number of participants achieving a pain free state within two hours and maintaining the pain free state for 24 hours after receipt of medication|2- 24 hours after receipt of medication|Please note that 1 patient in the metoclopramide arm and 1 patient in the ketorolac arm were lost-to-follow-up and did not provide data for this outcome|||Participants|||Count of Participants
1399371|NCT01267864|Primary|Headache Pain Level on a 0-10 Verbal Scale|Verbal Numerical Rating scale for pain. Absolute change from baseline. This is a 0-10 scale on which 0= no pain and 10= the worst pain imaginable.|60 minutes after receipt of medication||||units on a scale||95% Confidence Interval|Mean
1399372|NCT01267825|Secondary|Adverse Events|Any adverse events since randomization. %s will be compared between groups|1 week after discharge from emergency department|Study terminated due to low enrollment. No patient data was collected.||||||
1399373|NCT01267825|Secondary|Functional Disability Assessed Using Roland-Morris Scale|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, increasing functional disability."|1 month|Study terminated due to low enrollment. No patient data was collected.||||||
1399374|NCT01267825|Primary|Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians."|Baseline and one week after emergency department discharge|Study terminated due to low enrollment. No patient data was collected.||||||
1399375|NCT01267422|Secondary|Computerized Visual Field(VFI: Visual Field Index ,the Value Close to 100% Regarded Normal)|VFI: visual field index ,the value Close to 100% regarded normal. VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are VFI outcome measure of 8 patients.|||Percentage of normal||Standard Deviation|Mean
1399376|NCT01267422|Secondary|Computerized Visual Field(MD: Mean Deviation, the Value Close to 0 Regarded Normal)|MD: mean deviation, the value Close to 0 regarded normal.VFI/MD：The bigger one was more close to the normal value.|up to 3 years|Patient 2 refused the vision field test,there are MD outcome measure of 8 patients.|||dB||Standard Deviation|Mean
1399377|NCT01267422|Secondary|Average RNFL Thickness Througth Optical Coherence Tomography(OCT) Test|Average RNFL thickness of 8 patients througth Optical coherence tomography(OCT) test before and after treatment|Up to 3 years|RNFL thickness of 8 patients except Patient 1 because he once accepted the other eye's treatment|||Micrometer||Standard Deviation|Mean
1399381|NCT01267422|Primary|The Best Corrected Visual Acuity(BCVA)||Up to 3 years|The data are expressed as mean±standard error. Comparisons before and after treatment of the BCVA were analyzed using the paired t-test.A probability (P) value of less than 0.05 was considered statistically significant.Lower logMAR represents a better outcome.|||logMAR|logMAR|Standard Error|Mean
1399382|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|Monday of week 4||||number of perseverative errors||Standard Deviation|Mean
1399383|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|Thursday of week 1||||number of perseverative errors||Standard Deviation|Mean
1399384|NCT01267292|Secondary|Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task|The task is a rapid-presentation, probablistic gain/loss design. Reversal learning is assessed by means of a simple computerized card game. The paradigm utilizes a visual discrimination task where subjects have to learn to respond to outcome contingencies between two stimuli (high probability gain/low probability loss vs. low probability gain/high probability loss). At an unsignaled time point halfway into testing, the contingencies are reversed; the losing card becomes the winning card and the winning card becomes the losing one. Visual feedback regarding win or loss ($0.20) is provided after each trial and the cumulative total gained/lost is also shown. Using trial-and-error feedback, subjects have to discover which of the two patterns is correct and are instructed to win as much money as possible. The duration of the task is approximately 10 minutes, consisting of 80 trials.|baseline||||number of perseverative errors||Standard Deviation|Mean
1399385|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|Monday of week 4||||a-prime||Standard Deviation|Mean
1399386|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|Thursday of week 1||||a-prime||Standard Deviation|Mean
1399387|NCT01267292|Secondary|Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)|"Subjects are required to respond selectively to a series of stimuli (e.g., numbers) presented briefly for 500 ms with a 500 ms intertrial interval (ITI). Increases in false alarm rates are interpreted as failures in response inhibition. Five digit numbers are presented on a computer screen every 500 ms sec. Subjects are instructed to respond when the first number of a set was repeated. A hit response is scored when a subject correctly responds. Distracters consist of five-digit numbers that are completely different from the first, and numbers in which four of the five digits match the original, with the non-matching number occurring randomly across the five digit places. A response to the number with 4 of 5 digits correct is scored as a false alarm. The a-prime value reflects the ability of the participant to discriminate between signal (Go stimulus) and noise (No-Go stimulus) and ranges from 0.5 (chance level) to 1 (perfect discrimination)."|baseline||||a-prime||Standard Deviation|Mean
1399388|NCT01267292|Secondary|Diastolic Blood Pressure|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Diastolic blood pressure is the blood pressure when the heart muscle is between beats."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||mmHg||Standard Deviation|Mean
1402971|NCT01238588|Primary|Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score||Baseline and 6 months|Scans were done but not analyzed due to early study termination (per funding source).||||||
1399389|NCT01267292|Secondary|Systolic Blood Pressure|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Systolic blood pressure is the amount of pressure in the arteries during contraction of the heart muscle."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||mmHg||Standard Deviation|Mean
1399390|NCT01267292|Secondary|Heart Rate|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~Heart rate is the measure of heart beats per minute."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||beats per minute||Standard Deviation|Mean
1399391|NCT01267292|Secondary|"Subjective Effects as Assessed by the Elated Subscale of the Visual Analogue Scale (VAS)"|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The VAS presents 100-mm horizontal lines labeled with an adjective: “stimulated,” “high,” “anxious,” “elated,” “hungry,” and “nauseated.” The elated subscale is reported, and this sub scale is anchored by “not at all” (0) on the left and “extremely” (100) on the right, with a score range of 0-100. The higher the score, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
1399392|NCT01267292|Secondary|"Subjective Effects as Assessed by Score on the Feel High Subscale of the Drug Effects Questionnaire (DEQ)"|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The DEQ is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: “Feel Drug,” “Feel High,” “Like Drug,” and “Want More.” The Feel High subscale is reported, and this subscale is scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
1399393|NCT01267292|Secondary|Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS)|"The mean score over all 44 time points is reported in this outcome measure (i.e., the summary score is reported). Each subject contributed 11 data points for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 220 data points per dose level per arm.~The POMS is a self-rating measure of current mood, consisting of six subscales demonstrated to be sensitive to a range of acute drug effects, including amphetamine, cocaine, and caffeine. The six subscales are: depression, vigor, confusion, tension, anxiety, and fatigue. A 37-item short form of the POMS was used, which correlates highly with the full scale. The vigor subscale is reported, and the vigor subscale score ranges from 0 to 28, with 28 representing the highest score for that mood state. The higher the value, the worse the outcome."|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
1399394|NCT01267292|Secondary|Subjective Effects as Assessed by the Addiction Research Center Inventory (ARCI)|The ARCI short form will be used. It is a 49-item true / false questionnaire that has been empirically-derived to assess five different factors, including euphoria, sedation, and dysphoria. The PCAG scale has proven to be a sensitive measure of subjective effects in many studies administering stimulant drugs.|11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3|ARCI data were not collected.||||||
1399395|NCT01267292|Primary|Risky Decision Making as Assessed by Score on the Risky Decision Making Task|"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.~The risky decision making task provides subjects with three choice options on each of 100 repeated trials. Options are low, moderate, and high risk, based on variance and probability in gain/loss amounts. The low risk option is more adaptive over many trials. The outcome measure is a risk index (ranging from 0.33 to 100) that factors in tolerance for variability and amount of gains and losses across the three options. 100 is highest risk. 0.33 is lowest risk."|1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3||||units on a scale||Standard Deviation|Mean
1399396|NCT01267292|Primary|Attentional Bias as Assessed by Score on the Stroop Task|"The mean score over all 4 time points is reported in this outcome measure (i.e., a summary score is reported). Each subject contributed 1 data point for each dose level of Methylphenidate (15mg, 30mg, 60mg, or 0mg), resulting in a total of 20 data points per dose level per arm.~The Stroop task assesses attentional biases to cocaine-related (drug-related) and rewarding (non-drug related) stimuli vs. neutral stimuli. Participants are instructed to respond to words shown in different colors on the screen, by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words."|1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3||||milliseconds||Standard Deviation|Mean
1399397|NCT01267266|Secondary|Correlation of Molecular Profile With Clinical Outcomes|Study terminated after randomization of only 8 subjects. Correlative data not analyzed.|Up to 2 years|||||||
1399398|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events.|Percentage of patients who discontinued therapy due to toxicity.|Up to 6 months.||||percentage of participants||95% Confidence Interval|Number
1399399|NCT01267266|Secondary|Toxicity and Incidence of Adverse Events|Percentage of patients with grade 4 toxicity.|Up to 6 months.||||percentage of participants||95% Confidence Interval|Number
1399400|NCT01267266|Primary|Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)|Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.|Up to 6 months.|Two patients in the placebo arm censored at 12 and 17 weeks, respectively.|||weeks||Full Range|Median
1399401|NCT01267253|Other Pre-specified|Serum Expression Levels of Surrogate Markers of Brivanib Alaninate Effects Including Angiogenic Factors (VEGF and bFGF) and Markers of Endothelial Damage (E-selectin, VCAM-1, and ICAM-1)|Surrogate markers will be associated with response, PFS, and OS.|Up to 5 years|||||||
1399402|NCT01267253|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact..|From study entry to time of death or the date of last contact, up to 5 years of follow-up.|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1399403|NCT01267253|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to time of progression or death, whichever occurs first, up to 5 years of follow-up|Eligible and Treated Participants|||Months||95% Confidence Interval|Median
1399404|NCT01267253|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v.4.0|During treatment period and up to 30 days after stopping the study treatment.|Eligible and Treated Participants|||Participants|||Number
1399405|NCT01267253|Primary|PFS for at Least 6 Months Without Non-protocol Therapy From Study Entry.|Proportion of participants who survive progression-free for at least 6 months without non-protocol therapy from study entry. Progression is assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months therafter until disease progression confirmed; and at any other time if cliniclly indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and treated participants|||proportion||90% Confidence Interval|Number
1399406|NCT01267253|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response assessed by RECIST 1.1|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated participants|||proportion||90% Confidence Interval|Number
1399407|NCT01267240|Secondary|Progression-free Survival|"PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions."|From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.|16 of 25 patients were evaluable for response.|||months||95% Confidence Interval|Median
1399408|NCT01267240|Secondary|Survival|Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.|Up to 1 year|16 patients of the 25 were eligible for response assessment.|||months||95% Confidence Interval|Median
1399409|NCT01267240|Primary|Response Rate According to Response Evaluation Criteria in Solid Tumors|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.|Up to 1 year||||participants|||Number
1399410|NCT01267227|Secondary|Subjective Adverse Effects|Number of participants with adverse effects as a measure of safety|Baseline and 6-8 weeks||||participants|||Number
1399411|NCT01267227|Secondary|Blood Pressure|Reduction in systolic blood pressure versus placebo|6-8 weeks||||mmHg||95% Confidence Interval|Mean
1399412|NCT01267227|Primary|LDL|Increase in low density lipoprotein (LDL)|Baseline and 6-8 weeks||||mg/dL||95% Confidence Interval|Mean
1399413|NCT01267201|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1399414|NCT01267201|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hr||Full Range|Median
1399415|NCT01267201|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1399416|NCT01267201|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized participants who were treated and had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1399417|NCT01267175|Secondary|Usability of the Training Material Meets Expectations|Questionnaire completed at the end of the study, measuring usability of the device training manual. Results scored on a Likert scale of 1 - 7, 1 being the least user friendly and 7 being the most user friendly.|5 weeks||||Scores on a scale||Standard Deviation|Mean
1399418|NCT01267175|Primary|Usability of the X54 Insulin Pump Meets Expectations|Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.|5 weeks||||Scores on a scale||Standard Deviation|Mean
1399420|NCT01267136|Primary|Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.|Average number of post-operative days with pain score >4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).|Efficacy was assessed daily during the 10-day postoperative recovery period.||||days||Full Range|Median
1399421|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. “I disapprove of myself when I have irrational ideas”) by indicating how often they agree with the statement on a scale of 1 (“never or very rarely true”) to 5 (“very often or always true”). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.|8 months||||units on a scale||Standard Deviation|Mean
1399422|NCT01267045|Secondary|Five Facet Mindfulness Questionnaire|The Five Facet Mindfulness Questionnaire (FFMQ) measures five aspects of mindfulness: Observing, Describing, Acting with Awareness, Non-judging, and Non-reacting. It is a 39-item self-report questionnaire. Subjects respond to each statement (e.g. “I disapprove of myself when I have irrational ideas”) by indicating how often they agree with the statement on a scale of 1 (“never or very rarely true”) to 5 (“very often or always true”). Scores range from a minimum of 39 to a maximum of 195. Higher scores indicate greater levels of mindfulness.|2 months||||units on a scale||Standard Deviation|Mean
1399423|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. “How often did you feel tired?) with the following scale:~= never~= rarely~= sometimes~= often~= always~Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|8 months||||T-score||Standard Deviation|Mean
1399424|NCT01267045|Secondary|PROMIS Fatigue|"The self-report PROMIS Fatigue measure uses a maximum of 7 questions to assess fatigue symptoms over the past 7 days. Subjects respond to each question (e.g. “How often did you feel tired?) with the following scale:~= never~= rarely~= sometimes~= often~= always~Raw scores are converted to T-scores, which are standardized to a mean of 50. Scores above 50 indicate higher than average fatigue; scores below 50 indicate lower than average fatigue."|2 months||||T-score||Standard Deviation|Mean
1399425|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. “Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?”) by indicating how often per week he or she experiences that symptom. For each item, “not at all” is scored as 0; “once per week or less/a little” is scored as 1; “2 to 4 times per week/somewhat” is scored as 2; and “5 or more times per week/very much” is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.|8 months||||units on a scale||Standard Deviation|Mean
1399426|NCT01267045|Secondary|PTSD Symptom Severity Interview (PSSI)|The PTSD Symptom Severity Interview (PSSI) is a 17-question interview that measures the severity of PTSD symptoms in the past month. The interviewing researcher asks the subject to respond to each question (e.g. “Have you had recurrent or intrusive distressing thoughts or recollections about the trauma?”) by indicating how often per week he or she experiences that symptom. For each item, “not at all” is scored as 0; “once per week or less/a little” is scored as 1; “2 to 4 times per week/somewhat” is scored as 2; and “5 or more times per week/very much” is scored as 3. Total scores range from a minimum of 17 to a maximum of 51; the higher the score, the worse the outcome.|2 months||||units on a scale||Standard Deviation|Mean
1399427|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. “feeling tired or having little energy”), from “not at all” (0), to “nearly every day” (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.|8 months||||units on a scale||Standard Deviation|Mean
1399428|NCT01267045|Primary|Cognitive Failures Questionnaire|The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. “Do you find you forget why you went from one part of the house to another?”), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.|8 months||||units on a scale||Standard Deviation|Mean
1399429|NCT01267045|Primary|Cognitive Failures Questionnaire|The Cognitive Failure Questionnaire is a 25-item self-report measure of cognitive difficulty during daily living in the past six months. Each item is a question indicating a situation involving a type of cognitive failure (e.g. “Do you find you forget why you went from one part of the house to another?”), and the subject indicates how often that happens to them, on a scale of 0 (never) to 4 (very often). Scores range from a minimum of 0 to a maximum of 100; the higher the score, the worse the outcome.|2 months||||units on a scale||Standard Deviation|Mean
1399430|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|8 months||||units on a scale||Standard Deviation|Mean
1399431|NCT01267045|Primary|Multidimensional Fatigue Inventory - General Fatigue|"The Multidimensional Fatigue Inventory is a 20-item self-report measure of various types of fatigue. Each item is a statement, and the subject indicates how much, on a scale of 1 (yes, that is true) to 5 (no, that is not true), he or she agrees with the statement (e.g. I feel very active.) Scores range from a minimum of 20 to a maximum of 100; the higher the score, the worse the outcome."|2 months||||units on a scale||Standard Deviation|Mean
1399432|NCT01267045|Primary|The Short-Form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|8 months||||units on a scale||Standard Deviation|Mean
1399433|NCT01267045|Secondary|Patient Health Questionnaire (PHQ-9)|The Patient Health Questionnaire (PHQ-9) is a 9-item (with an additional 10th item if any of the previous 9 are endorsed) self-report measure of depression. Subjects are instructed to indicate how often, over the last 2 weeks, they have been bothered by each problem (e.g. “feeling tired or having little energy”), from “not at all” (0), to “nearly every day” (3). Scores range from a minimum of 0 to a maximum of 30; the higher the score, the worse the outcome.|2 months||||units on a scale||Standard Deviation|Mean
1399434|NCT01267045|Primary|The Short-form McGill Pain Questionnaire|The Short-Form McGill Pain Questionnaire is a self-report 22-item measure that assesses various types of pain on a scale of 0 (none) to 10 (worst possible) experienced during the past week. Score ranges from a minimum of 0 to a maximum of 220; the higher the score, the worse the outcome.|2 months||||units on a scale||Standard Deviation|Mean
1399435|NCT01267019|Secondary|Profile of Nonverbal Sensitivity (PONS)|"A measure of social perception. It is scored as number correct and higher is better. It ranges from 0 - 110.~Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.||||units on a scale||Standard Deviation|Mean
1399436|NCT01267019|Secondary|The Awareness of Social Inference Test (TASIT)|"A measure of mentalizing (i.e., making inferences about other people). It is scored for accuracy in which higher is better. It ranges from 0 - 64.~Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.||||units on a scale||Standard Deviation|Mean
1399437|NCT01267019|Primary|Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)|"A standardized measure of emotion processing. It is scored as a standard score with a population mean of 100 and standard deviation of 15. It can range from 0 to 200. Higher is better.~Note: Two of the study arms (in vivo and social cognitive training) receive identical procedures and produce identical outcome numbers for the first 6 weeks of the study."|baseline, 6 weeks, 12 weeks, and 3 months.||||units on a scale||Standard Deviation|Mean
1399438|NCT01266967|Secondary|Number of Response Genetics Incorporated (RGI) Investigational Use Only (IUO) Assay Mutation Positive Participants and THxID BRAF Assay Mutation Positive Participants With the Indicated Best Intracranial Response|The BRAF screening assay determines the specific BRAF mutational status (V600 E and K) in participants with metastatic melanoma who may benefit from treatment with GSK2118436. Per RECIST, version 1.1, CR is defined as the disappearance of all lesions. PR is defined as a >=30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline (BL) sum of the diameters (e.g., percent change from BL). Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is defined as a >=20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir [smallest sum of diameters recorded since treatment start]). In addition, the sum must have an absolute increase from nadir of 5 millimeters. Not evaluable: cannot be classified by a preceding definition.|Screening|V600EK and THIDEK Population: all enrolled participants who were V600E or V600K mutation positive by the RGI IUO assay|||participants|||Number
1399439|NCT01266967|Secondary|Composite of Pharmacokinetic Parameters of GSK2118436 in a Subset of Participants Receiving Dexamethasone|This outcome measure could not be analyzed because too few participants participated in the dexamethasone study.|Day 15|||||||
1399440|NCT01266967|Secondary|Median Concentrations of GSK2118436 and Its Metabolites Including GSK2285403, GSK2298683, and GSK2167542|Summary statistics were calculated for each time point by cohort. The population pharmacokinetics were determined using a non-linear mixed effects modeling approach after pooling the data with other studies. These results are reported separately.|Week 4 (pre-dose and 1-3 hours post-dose) and Weeks 8, 16, 24, and 32 (either pre-dose in the morning or in the afternoon at 4-8 hours post-dose)|PK Population: participants in the ATS population for whom a PK sample was obtained and analyzed. Only those participants whose samples were available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Full Range|Median
1399441|NCT01266967|Secondary|Number of Participants With Abnormal Echocardiograms (ECHO) at Weeks 4 and 12|Echocardiograms (ECHO) were measured for all treated participants. An echocardiogram test gives information about the structure and function of the heart. LLN=lower limit of normal (determined by the institution).|Weeks (W) 4 and 12|ATS Population|||participants|||Number
1399442|NCT01266967|Secondary|Number of Participants With a Worst-case On-therapy Increase From Baseline in Bazett's QTc Reading in the 12-lead Electrocardiogram (ECG)|An increase in the QTc interval corrected using Bazett's formula (Bazett's QTc) was recorded for all treated participants. Grade 1 (450-480 milliseconds [msec]), Grade 2 (481-500 msec), Grade 3/4 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade.|Baseline; Weeks 4, 12, 20, 28, 40, 52, and 64|ATS Population. Only those participants with data available at the indicated time points were analyzed.|||participants|||Number
1399443|NCT01266967|Secondary|Mean Blood Pressure at Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|Systolic and diastolic blood pressure were measured for all treated participants.|Baseline; Weeks 4, 8, 12, 16, 20, 24, 28, 32, and 36|ATS Population. Only those participants with data available at the indicated time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1399471|NCT01266876|Secondary|Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline HDL-C value.|||mg/dL||Standard Error|Least Squares Mean
1399472|NCT01266876|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint..|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment HDL-C value.|||percent change||Standard Error|Least Squares Mean
1399444|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Hematology Parameters|Hematology data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe, Grade 4, life threatening, Grade 5, death related to toxicity. Blood sample was collected for the assessment of hemoglobin, white blood cells, and platelet count.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.|||participants|||Number
1399445|NCT01266967|Secondary|Number of Participants With the Indicated Hepatobiliary Laboratory Abnormalities|Blood samples were collected for the assessment of hepatobiliary parameters. ALT=alanine aminotranserase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; BIL=total bilirubin; INR=international normalized ratio; ULN=upper limit of normal. Hepato-cellular injury is defined as (ALT/ULN)/(ALP/ULN) >=5.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population|||participants|||Number
1399446|NCT01266967|Secondary|Number of Participants With a Worst-case on Therapy Change to Grade 3 and Grade 4, or With Any Grade Increase (AGI), From Baseline Grade for Clinical Chemistry Parameters|Clinical chemistry data were summarized at each scheduled assessment according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, version 4.0). Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade (G) 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death related to toxicity. Blood sample was collected for the assessment of glucose, potassium, magnesium, sodium, phosphorus, potassium. aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatinine, total bilirubin, albumin, amylase, cholesterol, creatine kinase, gamma glutamyl transferase (GGT), lipase, blood pH, and triglycerides.|From Screening until the conclusion of the study (up to 103 weeks)|ATS Population. Only those participants with data available for the indicated parameters were analyzed.|||participants|||Number
1399447|NCT01266967|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From Screening until the conclusion of the study (up to 103 weeks)|All Treated Subjects (ATS) Population: all participants who received at least one dose of study treatment|||participants|||Number
1399448|NCT01266967|Secondary|Overall Survival in V600K Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 26 weeks)|V600K Population|||months||95% Confidence Interval|Median
1399449|NCT01266967|Secondary|Overall Survival of V600E Mutation-positive Participants|Overall survival (OS) is defined as the time from the first dose of study medication until death due to any cause. OS was censored using the date of last known contact for those participants who were alive at the time of analysis.|Time from the first dose of study medication until death due to any cause (average of 35 weeks)|V600E Population|||months||95% Confidence Interval|Median
1399450|NCT01266967|Secondary|Progression-free Survival in V600K Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 17 weeks)|V600K Population|||weeks||95% Confidence Interval|Median
1399451|NCT01266967|Secondary|Progression-free Survival in V600E Mutation-positive Participants|PFS is defined as the time from the first dose of study medication to the earliest of death or progression (at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). If a participant received subsequent anti-cancer therapy prior to the date of documented PD/death, the participant was censored at the last adequate assessment and the visit level response was CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters [e.g., percent change from Baseline]), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Time from the first dose of study medication to the earliest of death or progression (average of 23 weeks)|V600E Population|||weeks||95% Confidence Interval|Median
1399473|NCT01266876|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment total cholesterol value.|||mg/dL||Standard Error|Least Squares Mean
1399452|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600K Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial response was included in this analysis.|||weeks||95% Confidence Interval|Median
1399453|NCT01266967|Secondary|Duration of Overall Response for the Subset of V600E Mutation-positive Participants|Duration of Overall Response is defined as the time from the first documented evidence of overall CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of CR or PR until the time of the first documented disease progression or death due to any cause (average of 28 weeks)|V600E Population. Only the subset of participants who had a complete or partial response was included in this analysis.|||weeks||95% Confidence Interval|Median
1399454|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600K Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 31 weeks)|V600K Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.|||weeks||95% Confidence Interval|Median
1399455|NCT01266967|Secondary|Duration of Intracranial Response for the Subset of V600E Mutation-positive Participants|Duration of Intracranial Response is defined as the time from the first documented evidence of intracranial CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) until the time of the first documented intracranial disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm).|Time from the first documented evidence of intracranial CR or PR until the time of the first documented intracranial disease progression or death due to any cause (average of 27 weeks)|V600E Population. Only the subset of participants who had a complete or partial intracranial response was included in this analysis.|||weeks||95% Confidence Interval|Median
1399456|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With OIR, as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PF) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 16 weeks)|V600K Population|||participants|||Number
1399457|NCT01266967|Secondary|Number of Participants With V600K Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 17 weeks)|V600K Population: all participants with BRAF V600K mutation-positive melanoma who received at least one dose of study treatment|||participants|||Number
1399474|NCT01266876|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment total cholesterol value.|||percent change||Standard Error|Least Squares Mean
1399458|NCT01266967|Secondary|Number of Participants With V600E Mutation-positive Melanoma With a Best Overall Response (OR) of CR or PR, as Assessed by the Investigator|OR is defined as the number of participants achieving either a CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) per modified RECIST, version 1.1. To determine the OR, the extracranial response was combined with the intracranial response. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol-scheduled assessment. Participants who had an overall response of not evaluable or a missing response were treated as non-responders.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 24 weeks)|V600E Population|||participants|||Number
1399459|NCT01266967|Primary|Number of Participants With BRAF V600E Mutation-positive Melanoma With Overall Intracranial Response (OIR), as Assessed by the Investigator|OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PR) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis, OIR was measured when all participants in both treatment arms had two post-Baseline disease assessments. Participants who had an intracranial response of not evaluable or a missing response were treated as non-responders. Confirmation assessments were to be performed no less than 4 weeks after the criteria for response were initially met and may have been performed at the next protocol scheduled assessment.|From the time of the Baseline assessment until disease progression or end of study treatment (average of 18.3 weeks)|V600E Population: all participants with BRAF V600E mutation-positive melanoma who received at least one dose of study treatment|||participants|||Number
1399460|NCT01266876|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.|||mg/dL||Inter-Quartile Range|Median
1399461|NCT01266876|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.|||percent change||Inter-Quartile Range|Median
1399462|NCT01266876|Secondary|Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B and ApoA-1 value.|||ratio||Standard Error|Least Squares Mean
1399463|NCT01266876|Secondary|Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.|||mg/dL||Standard Error|Least Squares Mean
1399464|NCT01266876|Secondary|Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.|||percent change||Standard Error|Least Squares Mean
1399465|NCT01266876|Secondary|Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.|||mg/dL||Standard Error|Least Squares Mean
1399466|NCT01266876|Secondary|Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.|||percent change||Standard Error|Least Squares Mean
1399467|NCT01266876|Secondary|Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.|||mg/dL||Standard Error|Least Squares Mean
1399468|NCT01266876|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.|||percent change||Standard Error|Least Squares Mean
1399469|NCT01266876|Secondary|Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.|||mg/dL||Inter-Quartile Range|Median
1399470|NCT01266876|Secondary|Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.|||percent change||Inter-Quartile Range|Median
1399475|NCT01266876|Secondary|Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.|||percentage of participants|||Number
1399476|NCT01266876|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula.|Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.|||percentage of participants|||Number
1399477|NCT01266876|Secondary|Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|From Baseline to Week 12 (LOCF)|mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.|||mg/dL||Standard Error|Least Squares Mean
1399478|NCT01266876|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|From Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
1399479|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G4P8. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
1399480|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3|Blood was collected from all participants prior to vaccination and at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G3. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
1399481|NCT01266850|Secondary|Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotypes G1, G2, G4P6 and G9. A participant met the threshold of a positive response if the post vaccination antigen-specific antibody titer was 10 or greater.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
1399482|NCT01266850|Primary|Geometric Mean Serum Anti-rotavirus IgA Titer|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Mean
1399483|NCT01266850|Secondary|Number of Participants Experiencing Hematochezia at Any Time During the Study|Hematochezia was defined as any stools that are black and tarry; maroon in color; or frank red blood. At each visit, signs of hematochezia were assessed and the participant's parent/guardian was instructed to contact the clinical site at any time if the participant had evidence of hematochezia.|Day 1 through 6 months after the last vaccination|All participants who were vaccinated are included in the analysis population.|||participants|||Number
1399484|NCT01266850|Secondary|Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination|The participants' parent/guardian was given a memory aid to record for 8 days the presence of solicited reactions of fever, diarrhea and vomiting. Fever was considered experienced if the participant was assessed with an axillary temperature of 100.4F or greater on any day in the 8-day period after any vaccination. Diarrhea was considered experienced if the participant had 3 or more looser than normal stools in a day. Vomiting was considered experienced if the participant vomited 2 or more times in a day.|Days 1-8 after each vaccination|All participants who were vaccinated and had reactogenicity data reported are included in the analysis population.|||participants|||Number
1399485|NCT01266850|Secondary|GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9)|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the neutralizing antibody assay against the most common rotavirus serotypes, G1-G4 and G9. Antigen-specific geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.|3-6 weeks after the last dose of vaccine.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Mean
1399510|NCT01266161|Secondary|Pain Relief (PR) Scores|"A 5-point categorical pain relief rating scale was used to rate pain relief in response to the question: How much relief do you have from your starting pain? Responses were scored as follows: 0=none, 1=a little, 2=some, 3=a lot, 4=complete. Higher score indicated more pain relief."|0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
1399486|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
1399487|NCT01266850|Primary|Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay|Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.|3-6 weeks after the last vaccination|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
1399488|NCT01266824|Secondary|PIPP Score|PIPP score measure immediately following mydriatic drop administration|within 5 minutes after Mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
1399489|NCT01266824|Secondary|Bradycardia/Desaturation|Number of episodes of bradycardia (HR 90) and significant desaturation (event requiring stimulation, per Neonatal Intensive Care Unit (NICU) protocol, to resolve) occurring after the administration of mydriatic and proparacaine eye drops|Within 5 minutes after Proparacaine/mydriatic drop administration until study monitor disconnected|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
1399490|NCT01266824|Secondary|PIPP Score|PIPP scores measure immediately after Proparacaine administration|within 5 minutes after Proparacaine administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
1399491|NCT01266824|Primary|Change in PIPP Score|Comparison of the change in Premature Infant Pain Profile (PIPP) scores from baseline to the time immediately following mydriatic drop administration between the groups of infants who do and do not receive Proparacaine eye drops prior to mydriatic drops. The PIPP score is a scale to determined pain response that was designed for use in preterm and term infants. It is based on both physiologic and behavioral changes exhibited by infants during the study period of 30s (facial changes, HR, O2 saturation). There are correction factors for gestational age and baseline state at time of scoring. Scores can range from 0-21 with the maximum score dependent on the infant's gestational age. A score >7 typically indicates a pain response while a score >12 indicates more severe pain.|Change from baseline to time immediately following mydriatic drop administration|Due to poor enrollment, this study was not completed and no patients were analyzed as a part of the randomized controlled trial.||||||
1399492|NCT01266447|Secondary|Duration of Objective Response|Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented. Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months.|Eligible and Treated Patients with objective response|||Months||Full Range|Median
1399493|NCT01266447|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1399494|NCT01266447|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1399495|NCT01266447|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.|During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months.|Eligible and treated patients - No statistical analysis provided for adverse events (grade 3 or higher) during treatment period.|||Participants|||Number
1399508|NCT01266161|Secondary|Pain Relief Combined With Pain Intensity (PRID) Scores|"PRID score=PR plus PID. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: How much pain do you have at this time? (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; PID score ranged from -1 to 3; higher positive PID value=improvement. PRID scores ranged from -1 to 7. Higher PRID scores indicated better pain relief and decrease in pain intensity."|0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
1402999|NCT01238211|Secondary|Disease-free Survival|Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The median DFS with 95% CI was estimated using the Kaplan-Meier method.|Up to 10 years|||||||
1399496|NCT01266447|Primary|Number of Patients With Dose-limiting Toxicities (in Safety lead-in)|A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting >7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea & vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for >48 hours despite maximum medical management, electrolyte imbalance of > or equal to grade 3 that can be replaced within 48 hours; any drug related death|Up to 21 days|The first 6 eligible and treated patients who completed the 1st cycle of study treatment or had a DLT prior to completing the first cycle of study treatment|||participants|||Number
1399497|NCT01266447|Primary|Tumor Response|Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1399498|NCT01266317|Secondary|Number of Participants Survived to 60 Days or to Transplantation|The secondary outcome measures a composite outcome defined as survival to 60 days or survival to transplantation at any time post therapy.|60 days||||Participants|||Count of Participants
1399499|NCT01266317|Primary|Number of Participants With Respiratory and/or Hemodynamic Deteriorations|To assess the feasibility and safety of combined PEX, rituximab, and conventional corticosteroid administrations for the treatment of hospitalized patients with acute IPF exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function during the treatment interval. Respiratory deterioration was defined by a compilations of respiratory deteriorations (deteriorating gas exchange) and hemodynamic deteriorations (defined as a need for medical intervention).|28 days||||Participants|||Count of Participants
1399500|NCT01266291|Secondary|Number of Patients Who Become Seizure Free While Taking Sabril|"Seizure freedom~Responder rate (complex partial seizures only)"|Seizure freedom will be assessed for the two month treatment phase of the study (months 4 and 5)|One 30 year old female, Caucasian, non-Hispanic subject enrolled in the study. Due to adverse events, she did not complete the study, however, she completed all required follow-up.|||Participants|||Count of Participants
1399501|NCT01266291|Primary|Number of Participants Safely Tolerating Sabril|"Antiepileptic Drug (AED) levels in blood~Comprehensive panel (blood test)~Complete Blood Count with differential (blood test)~Visual field tests testing~Ophthalmology exam assessment~Frequency and severity of adverse events reported by subjects throughout their involvement with the study"|Outcome measures will be assessed at the initiation of Sabril (titration), and at three and five months after starting Sabril. After this time, the subjects will have completed the study.|One 30 year old female, Caucasian, non-Hispanic subject enrolled in the study. Due to adverse events, she did not complete the study, however, she completed all required follow-up.|||Participants|||Count of Participants
1399502|NCT01266265|Primary|Prevalence of Respiratory Tract-Related Adverse Events of Interest|Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.|Follow-up every 3 months||||percentage of participants|||Number
1399503|NCT01266161|Secondary|Participant Global Evaluation Score|"Participants responded, on a 6-point categorical scale, to the following question: How would you rate this medication as a pain-reliever? Responses on this categorical scale ranged as follows: 0=very poor, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent."|24 and 48 hours|ITT population|||units on a scale||Standard Deviation|Mean
1399504|NCT01266161|Secondary|Time to Meaningful Relief|Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that was considered meaningful to the participant.|Baseline to 12 hours|ITT population. Here, “Number of participants analysed signifies those participants who were evaluable for this outcome measures”.|||minutes||95% Confidence Interval|Median
1399505|NCT01266161|Secondary|Time to Confirmed First Perceptible Relief|The elapsed time from dosing until the participant indicated first perceptible pain relief by pressing the first stopwatch, provided the participant also indicated achieving meaningful relief by pressing the second stopwatch. Perceptible relief defined as when participant first began to feel any pain-relieving effect whatsoever of the drug. Did not necessarily mean the participant felt completely better, but when the participant first felt any difference in the pain he/she is currently feeling.|Baseline to 12 hours|ITT population. Here, “Number of participants analysed signifies those participants who were evaluable for this outcome measures”.|||minutes||95% Confidence Interval|Median
1399506|NCT01266161|Secondary|Number of Doses of Rescue Medication Used||0-12, 12-24, 24-36, 36-48, 0-48 hours|ITT population|||doses||Standard Deviation|Mean
1399507|NCT01266161|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR)|"TOTPAR is a derived endpoint from PR scores. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0=none, 1=a little, 2=some, 3=a lot, 4=complete). TOTPAR 0-12 scores ranged from 0 (worst) to 48 (best). TOTPAR 8-12 scores ranged from 0 (worst) to 16 (best)."|0-12 hours, 8-12 hours|ITT population|||units on a scale||Standard Deviation|Mean
1399509|NCT01266161|Secondary|Pain Intensity Difference (PID) Scores|"For pain intensity, How much pain do you have at this time? answered on a 4-point categorical scale. Responses were scored as follows: 0=none, 1=mild, 2=moderate, 3=severe. PID score=baseline pain intensity score minus score at each time point. PID scores ranged from -1 to 3. Higher positive PID scores indicated greater improvement (decrease in pain intensity)."|0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours|ITT population|||units on a scale||Standard Deviation|Mean
1399511|NCT01266161|Secondary|Percentage of Participants Taking Rescue Medication|Participants not experiencing adequate relief after the 1-hour time point during each dosing interval were allowed to take a single tablet (dose) of acetaminophen/hydrocodone HCl 500 mg/5 mg as a rescue medication (the only rescue medication allowed) during each interval.|Baseline to 48 hours|ITT population|||percentage of participants|||Number
1399512|NCT01266161|Secondary|Time to First Dose of Rescue Medication After First Dose of Study Drug|During the first 12 hours of the study, participants not experiencing adequate relief after the 1-hour time point were allowed to take a single tablet (dose) of acetaminophen/hydrocodone hydrochloride (HCl) 500 mg/5 mg as a rescue medication (the only rescue medication allowed). The time at which rescue medication was taken was recorded.|Baseline to 12 hours|ITT population. Here, “Number of participants analysed signifies those participants who were evaluable for this outcome measures”.|||hours||95% Confidence Interval|Median
1399513|NCT01266161|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID) Scores|"SPID is a derived endpoint from PID scores. For pain intensity, How much pain do you have at this time? answered on a 4-point categorical scale (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPID scores ranged as follows: 0 to 12 hour (-11.5 to 35.5), 8 to 12 hour (-6.0 to 18.0), 12 to 24 hour (-14.0 to 42.0), 20 to 24 hour (-8.0 to 24.0), 0 to 24 hour (-23.5 to 71.5), 24 to 36 hour (-16.0 to 48.0), 32 to 36 hour (-8.0 to 24.0), 36 to 48 hour (-16.0 to 48.0), 44 to 48 hour (-8.0 to 24.0), 24 to 48 hour (-28.0 to 84.0); higher positive values indicated improvement (decrease) in pain intensity."|0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours|ITT population|||units on a scale||Standard Deviation|Mean
1399514|NCT01266161|Primary|Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose|"SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: How much pain do you have at this time? (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy."|8 to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
1399515|NCT01266161|Primary|Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)|"SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: How much relief do you have from your starting pain? (0 equals [=] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: How much pain do you have at this time? (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy."|Baseline to 12 hours|Intent-to-treat (ITT) population: Randomized participants with at least moderate baseline pain (score 2 on the pain severity rating [PSR] scale) confirmed by a score of at least 50 millimeter (mm) on the 100-mm visual analog scale (VAS)-PSR, within approximately 5 hours after surgery, provided a baseline assessment, and received study medication.|||units on a scale||Standard Deviation|Mean
1399516|NCT01266148|Secondary|Change in Quality of Life - Euro Quality of Life 5D (EQ-5D)|Change in Quality of Life was assessed via the EQ-5D questionnaire which consists of: EQ-5D-5L descriptive system and EQ Visual Analogue scale (EQ VAS). The EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The patient indicates his/her health state by checking the most appropriate statement. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions are combined in a 5-digit number describing the respondent’s health state. The possible score is 1 to 5 where a lower number indicates improvement. The EQ VAS records the patient’s self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’. The score is 0 to 100 where a higher score represents improvement.|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1399517|NCT01266148|Secondary|Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment|Change in Quality of Life was assessed via the SF-36 (Minnesota Living with Heart Failure questionnaire ([MLHF)]) before transplant surgery and at week 52 of treatment. The SF-36 is a validated, self-administered questionnaire. The questionnaire, which includes 36 questions measures 8 dimensions of health: physical function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. Scores can be summarized in 2 summary components assessing physical and mental health. Items in each dimension are coded, aggregated, summed, and transformed into a scale ranging from 0 (worse health) to 100 (best health).|Pre transplant and 52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||Units on a scale||Standard Deviation|Mean
1399518|NCT01266148|Secondary|Lipid Profile at 12 Months|Total Cholesterol, LDL-Chol, HDL-Chol and TG at week 52. Measurements were taken via participants blood samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and had blood samples taken at week 52.|||mmol/L||Standard Deviation|Mean
1399519|NCT01266148|Secondary|Average Level of Protenuria at Week 52|Proteinuria is measured as the ratio of albumin/creatinine mg/mmol. Measurements were taken from participants urine samples.|52 weeks|The safety sert include all randomized participants who received at least one dose of study medication and were able to provide urine samples at week 52.|||mg/mmol||Standard Deviation|Mean
1403000|NCT01238211|Secondary|Cumulative Incidence of Death||Up to 10 years|||||||
1403001|NCT01238211|Secondary|Cumulative Incidence of Relapse||Up to 10 years|||||||
1399520|NCT01266148|Secondary|Occurrence of Treatment Failures up to 12 Months After Transplant|Treatment failure was defined as the number of participants who died or lost their graft at any timepoint througout the duration of the study.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||participants|||Number
1399521|NCT01266148|Secondary|Number of Rejections Leading to Hemodynamic Compromise|Number of all rejections were recorded through the duration of the study with the intent to identify rejections leading to hemodynamic compromise.|52 weeks|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||rejections|||Number
1399522|NCT01266148|Secondary|Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52|Calculated Glomerular Filtration Rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end of week 52.|Day 1, weeks 7 to 11 and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mGFR mL/min||Standard Deviation|Mean
1399523|NCT01266148|Secondary|Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52|Change in calculated glomerular filtration rate from pre-transplantation to week 52 was calculated according to the Modification of Diet in Renal Disease (MDRD) method. Measurements were taken prior to transplant (day 1), between weeks 7 to 11 and end week 52.|Day 1, weeks 7 to 11(baseline) and of week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mGFR mL/min||Standard Deviation|Mean
1399524|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52|the progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examinations, measured the incidence of CAV (in percent of patients) at baseline and at week 52. Incidence of CAV represents percent of patients having a MIT (maximal intima thickness) > 0.5 mm.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||Percentage of patients|||Number
1399525|NCT01266148|Secondary|Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52|The progression of chronic allograft vasculopathy (CAV) was assessed by intravascular ultrasound (IVUS) examinations and measured Maximal Intimal Thickness (MIT)(in mm). A major coronary epicardial artery (preferentially the left-anterior descending coronary artery) was imaged, and the MIT parameters were recorded at baseline and at week 52.|Baseline and week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mm||Standard Deviation|Mean
1399526|NCT01266148|Primary|Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation|Measured Glomerular Filtration Rate (mGFR) describes the flow rate of filtered fluid through the kidney. GFR is equal to the clearance rate when any solute is freely filtered and is neither reabsorbed nor secreted by the kidneys. The rate therefore measured is the quantity of the substance in the urine that originated from a calculable volume of blood. Participants’ urine was used for this assessment at week 52 after heart transplant.|Week 52|The intent to treat population includes the full analysis set patients with available data and without any major protocol deviations or criteria causing exclusion and for which data was available for analysis. Patients were analyzed according to the treatment to which they were randomized.|||mGFR ml/min||Standard Deviation|Mean
1399527|NCT01266122|Secondary|Changes in Psychosocial Mediators|We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.|up to 6 months|||||||
1399528|NCT01266122|Secondary|Acquisition of STIs - Number of Participants That Acquired STIs|We will test for locally relevant STIs at baseline and 6 months.|6 months||||participants|||Number
1399529|NCT01266122|Primary|Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant|We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.|up to 6 months||||number of unprotected sex acts||Standard Deviation|Mean
1399530|NCT01266070|Secondary|Number of VHL Participants With Response at 6 Months|Efficacy of treatment with dovitinib for 6 months in patients with VHL who have a measurable lesion evaluated by response using RECIST (Response Evaluation Criteria in Solid Tumors): Complete Response, Partial Response, Progressive Disease or Stable Disease.|Every 2 cycles (approximately 8 weeks) for 6 months||||Participants|||Count of Participants
1399531|NCT01266070|Primary|Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months|Most frequent & Most Serious Adverse Events: Safety of treatment with Dovitinib for 6 months in participants with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.|Every 2 cycles (approximately 8 weeks) for 6 months||||Participants|||Count of Participants
1399542|NCT01266031|Primary|Progression Free Survival (PFS) at 6 Months|"PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year.~Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial.~Study outcome measure period ended June 2015."|Baseline until disease progression or death due to any cause, up to six months||||Months||95% Confidence Interval|Median
1399532|NCT01266031|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle.||||Participants|||Count of Participants
1399533|NCT01266031|Secondary|Radiological Response|Magnetic resonance imaging (MRI) and contrast-enhanced (CE) MRI was used to evaluate tumor response. Response is defined by the Modified MacDonald criteria. Complete Response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. Partial Response, Non-Measurable (PRNM) is not applicable. Stable/No Response does not qualify for CR, PR or progression. Progression is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).|End of therapy, approximately|This outcome measure was not done. We collected radiological response data provided by the local physician at time points per protocol. At the end of the study, the plan was to send all MRI discs to one radiologist for central review to confirm responses. With only limited funding, and negative findings, the PI decided to not pursue this outcome.||||||
1399534|NCT01266031|Secondary|Mean Symptom Interference at the Time of Clinical Evaluation|Overall mean interference severity of 6 interference items. Interference is rated 0-10, zero is “did not interfere” and 10 is “as bad as you can imagine”. All patients with at least one valid questionnaire will be included in the analyses.|Baseline, (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)|Overall analysis was done but not done by treatment arm/group.|||score on a scale||Standard Deviation|Mean
1399535|NCT01266031|Secondary|Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool|Overall mean severity of 22 symptoms. Symptoms are rated 0-10, zero is “not present” and 10 is “as bad as you can imagine”. All patients with at least one valid questionnaire will be included in the analyses.|Baseline, week 4 (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)|Overall analysis was done but not done by treatment arm/group.|||score on a scale||Standard Deviation|Mean
1399536|NCT01266031|Secondary|Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool|"Percentage of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is not present and 10 is as bad as you can imagine. All patients with at least one valid questionnaire will be included in the analyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures."|Baseline, week 4, week 8, and end of therapy, approximately week 52 (cycle 12)|Reason outcome measure #7 is not done per arm/group is it was intentionally not completed due to negative findings of the study’s primary outcomes.|||percentage of of participants|||Number
1399537|NCT01266031|Secondary|Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Stromal Cell-derived Factor α (SDF1α), and Angiopoietin 1 (Ang 1) and 2 (Ang 2) by Enzyme-linked Immunosorbent Assay (ELISA)|About 5cc of blood was collected to measure plasma angiogenic proteins stromal cell-derived factor α (SDF1α), angiopoietin 1 and 2 by enzyme-linked immunosorbent assay (ELISA).|Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)|This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.||||||
1399538|NCT01266031|Secondary|Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Vascular Endothelial Growth Factor (VEGF), Placental Growth Factor (PIGF), and Basic Fibroblast Growth Factor (bFGF)|About 5cc of blood was collected to measure plasma angiogenic proteins vascular endothelial growth factor (VEGF), placental growth factor (PIGF), and basic fibroblast growth factor (bFGF) by enzyme-linked immunosorbent assay (ELISA).|Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)|This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.||||||
1399539|NCT01266031|Secondary|Overall Survival (OS)|OS was computed using the number of months from the date of randomization to the date of death, up to 30 months. Participants still alive were censored at the last follow-up date.|up to 30 months.||||Months||95% Confidence Interval|Median
1399540|NCT01266031|Secondary|Time to Progression (TTP)|Progression defined by the Modified MacDonald criteria is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).|3, 6, and 12 months from patient registration||||Months||95% Confidence Interval|Median
1399541|NCT01266031|Primary|Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab|MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), using conventional Phase I design where the MTD was selected using a 3+3 accrual design at each dose level until MTD was determined. Toxicities will be graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0.|28 day, cycle 1||||mg/day|||Number
1403002|NCT01238211|Secondary|Complete Response Rate|"Percentage of participants who achieve a CR.~CR is defined in the above outcome measure."|Up to 10 years|||||||
1399543|NCT01266018|Secondary|Assessment of Overall Survival|Overall survival was measured from the initial date of treatment to the recorded date of death. Because the study was terminated prematurely, no statistical analyses of overall survival data were performed.|Every 4 weeks for up to 16 months|Subjects who had survival status recorded during post-study follow-up.|||Participants|||Count of Participants
1399544|NCT01266018|Secondary|Assessment of Immunogenicity of ADI-PEG 20|Blood samples were collected for all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in ADI-PEG 20 antibody titer in peripheral blood over time. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.|Every 1 to 4 weeks for up to 16 weeks|The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.|||log 10 IU/mL||Full Range|Mean
1399545|NCT01266018|Secondary|Assessment of Pharmacodynamics of ADI-PEG 20|Blood samples were collected from all subjects at enrollment, prior to each treatment, and at the end of study to evaluate changes in plasma arginine and citrulline levels following administration of ADI-PEG 20. Disease state (ie, relapsed sensitive vs refractory) was not considered relevant to this analysis and as such samples were collected without regard for cohort assignment.|Every 1 to 4 weeks for up to 16 weeks|The Pharmacodynamic Analysis Set comprises all subjects who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses. A total of 121 plasma samples from 21 subjects were analyzed. Summary data are presented through Day 58, i.e., the last time point with at least 3 samples available for calculation of a mean.|||uM||Full Range|Mean
1399546|NCT01266018|Secondary|Assessment of Safety of Arginine Deiminase Pegylated (ADI-PEG) 20|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.|Every 1 to 4 weeks for up to 16 weeks|The Safety Analysis Set comprises all subjects who received at least 1 dose of study drug.|||participants|||Number
1399547|NCT01266018|Primary|Best Overall Response|"Tumor responses were evaluated using any appropriate imaging type and were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST for target lesions and assessed by MRI:~Complete Response (CR): Disappearance of all target lesions [no evidence of disease]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria."|Every 4 to 8 weeks for up to 16 weeks|Includes all patients who were evaluable for tumor response allocation.|||participants|||Number
1399548|NCT01265992|Secondary|Number of Participants Using Concomitant Medications at Baseline||Baseline|Full analysis set|||participants|||Number
1399549|NCT01265992|Secondary|Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism|"Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days.~Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment.~Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature."|6 months|Participants who were working for pay and with available data at both time points.|||Swedish krona per participant||Standard Deviation|Mean
1399550|NCT01265992|Secondary|Total Direct Costs of Care Associated With Secondary Hyperparathyroidism|Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation.|6 months|||||||
1399551|NCT01265992|Secondary|Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)|"The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 (worst possible health) to 10 (best possible health).~Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life."|Baseline and 6 months|Per-protocol analysis set with available data at both time points.|||units on a scale||Standard Deviation|Mean
1399552|NCT01265992|Secondary|Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline||Baseline and 6 months|Per-protocol analysis set. Percentages are based on the total number of participants in the per-protocol analysis set.|||percentage of participants|||Number
1399553|NCT01265992|Secondary|Change From Baseline in Proteinuria|Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine.|Baseline and Month 6|Per-protocol analysis set with available data at both time points.|||g/L||Standard Deviation|Mean
1399554|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months|Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.|Baseline and 6 months|Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).|||percentage of participants|||Number
1399555|NCT01265992|Primary|Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months|"Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as:~Stage 3 CKD: ≥ 1.49 mmol/L;~Stage 4 CKD: ≥ 1.49 mmol/L;~Stage 5 CKD: > 1.78 mmol/L."|Baseline and 6 months|Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).|||percentage of participants|||Number
1399556|NCT01265992|Primary|Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months|"Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are:~Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 – 59 mL/min): 3.85 – 7.7 pmol/L;~Stage 4 CKD (eGFR 15 – 29 mL/min): 7.7 – 12.1 pmol/L;~Stage 5 CKD (eGFR < 15 mL/min): 16.5 – 33 pmol/L.~*Calculated using the Modification of Diet in Renal Disease formula."|Baseline and 6 months|Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40).|||percentage of participants|||Number
1399557|NCT01265992|Primary|Change From Baseline in Intact Parathyroid Hormone at 6 Months||Baseline and 6 months|Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points.|||pmol/L||Standard Deviation|Mean
1399558|NCT01265966|Primary|Change From Baseline to Peak Salivary Cortisol Level|Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.|Baseline, then every 30 minutes, and at end of procedure|All patients with adequate samples for analysis.|||Number (ratio of peak to baseline)||Standard Error|Mean
1399559|NCT01265953|Primary|Expression of Histone Deacetylase 6 (HDAC6)|Immunohistochemical (IHC) analysis of HDAC6 expression using research-only prostate biopsy tissue collected post-intervention at the time of the clinically-indicated prostate biopsy. A modified Histo-score (H-score) was calculated, which involved semiquantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate, and 3 strong) and percentage of positive cells. H-score ranged from 0 to 300 with 300 the strongest expression.|minimum 4 to maximum 8 weeks; prostate biopsy were collected post-intervention when clinically-indicated||||H-score||Standard Error|Mean
1399560|NCT01265953|Primary|Expression of Ki67|Ki67 is a biomarker of disease progression. Immunohistochemical (IHC) analysis of Ki67 was performed using research only prostate biopsy specimens collected post-intervention at the time of the clinically-indicated prostate biopsy.|minimum 4 to maximum 8 weeks; prostate biopsy were collected post-intervention when clinically-indicated|Some subjects did not have post-intervention prostate tissue that can be used for IHC analysis, therefore, the overall number of participants analyzed for IHC analysis is different from the total enrolled subjects.|||% of positivity||Standard Error|Mean
1399561|NCT01265953|Primary|Change of Total Plasma SFN (Sulforaphane) Metabolites Level|In subjects at risk for prostate cancer, presence of SFN was analyzed in plasma. Collection of blood specimens occurred at pre-intervention and post-intervention. The Change = post-intervention level minus pre-intervention level|minimum 4 to maximum 8 weeks|We missed blood samples from some subjects, therefore, total number of subjects analyzed for the plasma-based analysis is different from the number of total enrolled subjects.|||micromolar (µM)||Standard Error|Mean
1399562|NCT01265953|Primary|Change of Total Urine SFN (Sulforaphane) Metabolites|Collection of blood and urine specimens occurred at pre-intervention and post-intervention. Change = post-intervention level minus pre-intervention level|minimum 4 to maximum 8 weeks|Not all subjects had urine samples for analysis, therefore, the total number of subjects in this urine analysis is different from total number of enrolled subjects.|||micromolar (µM) concentrations of urina||Standard Error|Mean
1399563|NCT01265875|Secondary|VAS Score at Each Administered Dose.|10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3.|Days 1, 2, and 3.||||units on a scale||Standard Deviation|Mean
1399564|NCT01265875|Primary|Quality of Life at Baseline, Day 4 and Day 30.|Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes.|Baseline, Day 4, Day 30.||||units on a scale||Standard Deviation|Mean
1399565|NCT01265875|Primary|Opiate Use at Baseline, Days 4 and 30.|Daily opiate use (oral morphine equivalent).|Baseline, Day 4, Day 30.||||mg/day||Standard Deviation|Mean
1399566|NCT01265875|Secondary|Number of Participants With Serious Adverse Events.||30 Days||||participants|||Number
1399567|NCT01265875|Primary|VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.|10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day.|Baseline, Days 1, 2, 3, 4, 7, 30.||||units on a scale||Standard Deviation|Mean
1399568|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 16|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 16|Participants with available data at given time points.|||pg/mL||Standard Deviation|Mean
1399569|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 16|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 16|Participants with available data at given time points.|||nmol/L||Standard Deviation|Mean
1399570|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 16|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 16|Participants with available data at given time point.|||ng/mL||Standard Deviation|Mean
1399571|NCT01265823|Secondary|Serum Levels of Vitamin B12 at Baseline and Week 4|Normal values for vitamin B12 were 200-1100 pg/mL.|Baseline, Week 4|Participants with available data at given time points.|||pg/mL||Standard Deviation|Mean
1399572|NCT01265823|Secondary|Serum Levels of Vitamin B6 at Baseline and Week 4|Normal values for vitamin B6 were 18-175 nmol/L.|Baseline, Week 4|Participants with available data at given time points.|||nmol/L||Standard Deviation|Mean
1399573|NCT01265823|Secondary|Serum Levels of Folic Acid at Baseline and Week 4|Normal values for folic acid were 3-15 ng/mL.|Baseline, Week 4|Participants with available data at given time points.|||ng/mL||Standard Deviation|Mean
1399608|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
1399574|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of >1 for men and >0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT population|||percentage of participants|||Number
1399575|NCT01265823|Secondary|Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16|The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).|Week 16|ITT Population|||percentage of participants|||Number
1399576|NCT01265823|Secondary|Mean Homocysteine Levels at Baseline and Week 16|Normal values for homocysteine were 5-13.9 µmol/L.|Baseline, Week 16|Participants with available data at given time points.|||µmol/L||Standard Deviation|Mean
1399577|NCT01265823|Secondary|Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16|Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.|Baseline, Week 16|Participants with available data at given time points.|||mg/dL||Standard Deviation|Mean
1399578|NCT01265823|Secondary|Physician’s Global Assessment (PGA) at Week 16|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present). The number of participants who achieve a PGA of 'clear' or 'almost clear' at Week 16 was a secondary outcome measure in this study.|Week 16|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
1399579|NCT01265823|Secondary|Physician's Global Assessment (PGA) at Week 4|The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).|Week 4|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
1399580|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 16|ITT population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
1399581|NCT01265823|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.|Week 4|ITT population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
1399582|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 16|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
1399583|NCT01265823|Secondary|Dermatology Life Quality Index (DLQI) Categories at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant’s life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.|Week 4|ITT population. Participants with missing scores were considered nonresponders.|||participants|||Number
1399624|NCT01265667|Secondary|Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75|Achievement of PASI 50 or 75 indicates a 50% and 75% reduction respectively in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)|16 weeks|Analysis performed of the ITT population|||participants|||Number
1399584|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 16|Participants with evaluable data at given time points.|||units on a scale||Standard Deviation|Mean
1399585|NCT01265823|Secondary|Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Baseline, Week 4|Participants with evaluable data at given time points.|||units on a scale||Standard Deviation|Mean
1399586|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
1399587|NCT01265823|Primary|Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant’s life.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
1399588|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.|Week 16|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
1399589|NCT01265823|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.|Week 4|Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.|||percentage of participants|||Number
1399590|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and open label month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|Score recorded at the end of run-in and open label month||||score on a scale||95% Confidence Interval|Mean
1399591|NCT01265797|Secondary|Epworth Sleepiness Scale Score|"Mean difference of Epworth Sleepiness Scale score between run-in month and blinded month. The Epworth Sleepiness Scale is used to measure excessive daytime sleepiness. This is an 8 item questionnaire, recalling probability of falling asleep in recent times. The subjects are asked to rate probability of falling asleep in eight different situations. The score for each item ranges from 0 (would never doze) to 3 (high chance of dozing), with the overall score range of 0 to 24. Higher scores represent higher probability of falling asleep."|recorded at the end of run-in month and blinded month||||score on a scale||95% Confidence Interval|Mean
1399592|NCT01265797|Secondary|Somatic Symptom Score (Patient Health Questionnaire-15)|"Mean difference in PHQ 15 score between run-in month and open label month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms."|28 day period in run-in month and open label month||||score on a scale||95% Confidence Interval|Mean
1399593|NCT01265797|Secondary|Somatic Symptom Severity (Patient Health Questionnaire 15)|"Mean difference in PHQ 15 score between run-in month and blinded month. The PHQ-15 comprises 15 somatic symptoms experienced over the prior 4 weeks and their severity, each symptom scored from 0 (not bothered at all) to 2 (bothered a lot). The range for the overall score is between 0 and 30, with higher score representing more severe somatic symptoms"|28 days recall; measured at end of run-in month and blinded month||||score on a scale||95% Confidence Interval|Mean
1399594|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and open label month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 day recall, recorded at the end of run-in and open label months||||score on a scale||95% Confidence Interval|Mean
1399595|NCT01265797|Secondary|Generalized Anxiety Disorder Score (GAD 7)|Mean difference in GAD 7 score between run-in month and blinded month. This is a screening tool and severity measure for generalized anxiety disorder addressing symptoms over the prior 2 weeks. It is a 7 item questionnaire with response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety|14 days recall; measured at end of run-in month and blinded month||||score on a scale||95% Confidence Interval|Mean
1399596|NCT01265797|Secondary|Headache Impact Test (HIT-6) (Measure of Disability Due to Headaches)|Mean difference in HIT-6 score between run-in month and open label month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|28 day period in run-in month and open label month||||score on a scale||95% Confidence Interval|Mean
1399597|NCT01265797|Secondary|Headache Impact Test-6|Mean difference in HIT-6 score between run-in month and blinded month. The HIT-6 is a tool for screening and monitoring change in headache disability. This disease-specific health survey is intended for adults 18 years of age and older, and is available with a standard four-week recall period. It is a 6 item questionnaire with scores for each item ranging from 6 (never) to 13 (always). The minimum overall score is 36 and the maximum is 78. Higher scores represent greater disability.|after run-in month, after blinded month||||score on a scale||95% Confidence Interval|Mean
1399598|NCT01265797|Primary|Depression Score (PATIENT HEALTH QUESTIONNAIRE [PHQ] 9)|Mean difference of PHQ-9 score between the run-in month and blinded month, i.e. PHQ-9 score from run-in month minus blinded month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 days recall; measured at end of run-in month and blinded month|The number of participants included the individuals who have completed the run-in period and the blinded period. The data was analyzed 'per protocol' based on the number of participants completing the blinded period.|||depression score/14 day recall||95% Confidence Interval|Mean
1399599|NCT01265797|Secondary|Depression Score (Patient Health Questionnaire-9)|Mean difference of PHQ-9 score between the run-in month and open label month, i.e. PHQ-9 score from run-in month minus open label month. The PHQ-9 is a tool for assisting in diagnosing depression (over the prior 2 week period) as well as selecting and monitoring treatment. There are nine items, with responses each ranging from 0 (not at all) to 3 (nearly every day), for a total range of 0 to 27. The higher the total the more severe the depressive symptoms.|14 day recall, recorded at the end of run-in and open label months||||score on a scale||95% Confidence Interval|Mean
1399600|NCT01265797|Secondary|Headache Days|Mean change in headache days between 28 day run-in month and 28 day open label month, i.e. run-in month mean minus open label month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period in run-in month and open label month||||headache days/ 28 day period||95% Confidence Interval|Mean
1399601|NCT01265797|Primary|Mean Headache Days|Mean change in headache days between 28 day run-in month and 28 day blinded month, i.e. run-in month mean minus blinded month mean. A good response is >= 50% reduction in headache days (congruent with the Guidelines for Trial of Behavioral Treatments for Recurrent Headache).|28 day period during run-in month and blinded month||||headache days/ 28 day period||95% Confidence Interval|Mean
1399602|NCT01265784|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve From Time 0 to 12 Hours (AUC[0-12]) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable AUC(0-12) data.|||nanogram*hours per milliliter (ng*h/mL)||Standard Deviation|Mean
1399603|NCT01265784|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of TP-434||Prior to first infusion and 1, 3, 7, 12, 48, and 108 hours after start of first infusion|All randomized participants without significant protocol deviations who received at least 1 dose of TP-434 and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1399604|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
1399605|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the ME Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
1399606|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
1399607|NCT01265784|Secondary|Microbiologic Response to TP-434 and Ertapenem in the m-MITT Population at the EOT Visit|Microbiological response was classified as favorable (eradication or presumed eradication), unfavorable (persistence, presumed persistence, superinfection, or new infection), or indeterminate (assessment not possible).|EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
1399625|NCT01265667|Secondary|Number of Subjects Achieving PGA of 0 or 1|PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe)|16 weeks|Analysis was performed on the ITT population|||participants|||Number
1399609|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
1399610|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.|||participants|||Number
1399611|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.|||participants|||Number
1399612|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Evaluable (CE) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and for whom sufficient information was available to determine the participant’s outcome with no confounding factors present that interfered with the assessment of that outcome.|||participants|||Number
1399613|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the Follow-up Visit||Follow-Up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
1399614|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
1399615|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Modified Intent-to-treat (m-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, and had a baseline pathogen identified. The minimal disease definition of cIAI included IAI that extended beyond the hollow viscus of origin into the peritoneal space and was associated with either abscess formation or peritonitis.|||participants|||Number
1399616|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.|||participants|||Number
1399617|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of IAI. The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.|||participants|||Number
1399618|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Clinically Modified Intent-to-treat (c-MITT) Population at the EOT Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug and met the minimal disease definition of intra-abdominal infection (IAI). The minimal disease definition included all IAI, whether complicated or not. Identification of a baseline pathogen was not required for this population.|||participants|||Number
1399619|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the Follow-up Visit||Follow-up Visit (28-42 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1399620|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at TOC Visit||TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1399621|NCT01265784|Secondary|Clinical Response to TP-434 and Ertapenem in the Modified Intent-to-treat (MITT) Population at the End-of-Treatment (EOT) Visit||EOT Visit (4-14 days after first dose of study drug)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1399622|NCT01265784|Primary|Clinical Response to TP-434 and Ertapenem in the Microbiologically Evaluable (ME) Population at the Test-of-Cure Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (Test-of-Cure [TOC] assessment was not available, death unrelated to cIAI, or some other reason).|TOC Visit (10-14 days after last dose of study drug)|All randomized participants who received at least 1 dose of study drug, met the minimal disease definition of cIAI, had a baseline pathogen identified, and had a microbiological response assessed.|||participants|||Number
1399623|NCT01265667|Secondary|Nature and Frequency of Adverse Events|Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data|32 weeks||||Participants|||Count of Participants
1399626|NCT01265667|Primary|Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks|Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)|12 weeks|Analysis was performed on the Intent-to-treat (ITT) Population|||Participants|||Count of Participants
1399627|NCT01265615|Secondary|Coronary Calcium Score|Bone mineral density assessed by dual-energy X-ray absorptiometry (DXA) of the whole body, lumbar spine and hip was performed using Hologic scanners (QDR 1000W or QDR 2000). The total Agatston coronary calcium score (CCS) was measured as the sum of calcified plaque scores of all the coronary arteries. The amount of calcium present in the coronary arteries is scored according to the Agatson scale, as follows: 0 - no identifiable disease; 1 to 99 - mild disease; 100 to 399 - moderate disease; 400 or higher - severe disease.|on day 180||||units on a scale||Standard Deviation|Mean
1399628|NCT01265615|Secondary|Systolic Blood Pressure|SBP measured by routine method|on day 180||||mmHg||Standard Deviation|Mean
1399629|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Kidney|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180||||fmol VDR/ mg protein||Standard Deviation|Mean
1399630|NCT01265615|Secondary|VDR (Vitamin D Receptor) Expression in Myocardium|VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.|on day 180||||fmol VDR/ mg protein||Standard Deviation|Mean
1399631|NCT01265615|Secondary|Number of Circulating SP (Side Population) Stem-Progenitor Cells|Renal cells and solid tissue were obtained from the normal portion of cortex obtained from surgically removed kidneys or by standart biopsy on day 180. Cytofluorimetric analysis and immunofluorescence were performed as described by Oliver J.A. (2004). Sorting and analysis of different cells was done on a FACS (fluorescent activated cell sorting) and by flow cytometry. Cells were analyzed with EPICS systems (Beckman Coulter). Quantification of mRNA expression was achieved using Assays-on-Demand gene expression kits and the ABI PRISM 7000 Sequence Detection System (Applied Biosystem).|on day 180||||per cent of SP cells||Standard Deviation|Mean
1399632|NCT01265615|Secondary|Serum Creatinine|After an overnight fast, plasma concentrations of hemoglobin, creatinine, cholesterol, glucose, total calcium, and phosphate were measured using an autoanalyzer as described by Adorini L. (2005)|on day 180 after Tx||||mg/dL||Standard Deviation|Mean
1399633|NCT01265615|Secondary|CAD (Chronic Allograft Dysfunction) Degree|"CAD degree measured by Banff score after routine renal biopsy (revised 2005/2007 criteria). We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|on day 90||||Scores on a Banff scale||Standard Deviation|Mean
1399634|NCT01265615|Secondary|GFR (Glomerular Filtration Rate)|Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated form of the Modification of Diet in Renal Disease (MDRD) study equation: eGFR = exp (5.228 − 1.154 × ln (serum creatinine) − 0.203 × ln (age). Concerning of GFR with Tc99m DTPA renography was used for the complex analysis of renal function. Camera based GFR estimated from Tc99m DTPA renography was named Gates GFR.|on day 180||||ml/min/1.73 m^2||Standard Deviation|Mean
1399635|NCT01265615|Secondary|Heart Failure (HF)|"NYHA (New York Heart Association) functional class verified with veloergometry probe and by NYHA clinical classification NYHA Class Symptoms I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.~II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m).~Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|on day 180 after Tx (transplantation)|A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 40 nmol/l) were assigned. Analysis was per protocol.|||NYHA functional class of HF||Standard Deviation|Mean
1399636|NCT01265615|Primary|CAD (Chronic Allograft Dysfunction) Degree|"Beyond 180 days, chronic allograft dysfunction (CAD) was characterized by mean Banff degree (revised 2005/2007 criteria) with the data of renal biopsy material. Renal tissue was recovered during routined biopsy. We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:~Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)"|day 180 after Tx (transplantation)||||Scores on a Banff scale||Standard Deviation|Mean
1399637|NCT01265563|Secondary|Urinary Alpha-1 Microglobulin, Inflammatory Cytokines and C-C Chemokines|Urinary alpha-1 microglobulin, inflammatory cytokines and C-C chemokines were never measured and analysed.|Baseline and 3 months|||||||
1399638|NCT01265563|Secondary|Change From Baseline in Hemoglobin-A1c|Hemoglobin A1C was assessed at the end of the run in period and after 3 months of administration of study interventions. Here is delta HgA1C is reported between the two periods|Baseline and 3 months||||percentage||Standard Deviation|Mean
1399639|NCT01265563|Primary|Change From Baseline in Urinary Albumin Excretion|Urine albumin to creatinine ratio was assessed at the end of run in period and after 3 months administration of study intervention.|Baseline and 3 months||||mg/g||Standard Deviation|Mean
1399640|NCT01265550|Secondary|Number of Successful Participants With Functional Gallbladder Disorder|Presence of functional gallbladder disorder as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes|||Participants|||Count of Participants
1399641|NCT01265550|Secondary|Number of Successful Participants With Unspecified Functional Bowel Disorder|Presence of unspecified functional bowel disorder as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1399642|NCT01265550|Secondary|Number of Successful Participants With Functional Diarrhea|Presence of functional diarrhea as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes|||Participants|||Count of Participants
1399643|NCT01265550|Secondary|Number of Successful Participants With Functional Bloating|Presence of functional bloating as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1399651|NCT01265550|Secondary|Number of Successful Participants With Functional Chest Pain of Presumed Esophageal Origin|Presence of functional chest pain of presumed esophageal origin as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1399652|NCT01265550|Secondary|Number of Successful Participants With Functional Heartburn|Presence of functional heartburn as assessed by the ROME III functional GI disorders questionnaire.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1399653|NCT01265550|Secondary|Number of Successful Participants With Anxiety and/or Depression.|Association between anxiety and/or depression (GAD-7 and PHQ-9) and the outcome of medical and surgical treatments (success or failure) will be evaluated.|12 months|Number of treatment successes.|||Participants|||Count of Participants
1399654|NCT01265550|Primary|Number of Participants Achieving at Least a 50% Improvement in the Gastroesophageal Reflux Disease Health-related Quality of Life Index (GERD-HRQL) From Baseline to 12 Months|"Success; ≥50% improvement in the baseline GERD-HRQL score at 12 months.~Failure; <50% improvement in the baseline GERD-HRQL score at 12 months or:~For patients randomized to Surgical Treatment: a.<50% improvement in the baseline GERD-HRQL score and/or persistent heartburn of sufficient severity to warrant treatment with any antisecretory medication, antireflux medication or neurotropic medication at any quarterly clinic visit.~For patients randomized to Active Medical or Placebo Medical Treatment:~a.inability to tolerate both study medications or b.For patients treated with desipramine, i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with the second drug at any quarterly clinic visit. c.For patients in whom desipramine is contraindicated,i.<50% improvement in baseline GERD-HRQL score symptom after at least 10 weeks of treatment with baclofen or its corresponding placebo at any quarterly clinic visit."|12 months||||Participants|||Count of Participants
1399655|NCT01265524|Secondary|6MWT Distance at Week 8|Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||m||Standard Deviation|Mean
1399656|NCT01265524|Secondary|Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8||Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||participants|||Number
1399657|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.|8 weeks||||participants|||Number
1399658|NCT01265524|Secondary|Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4|The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.|4 weeks||||participants|||Number
1399659|NCT01265524|Secondary|Weight Loss at Week 2||Baseline and 2 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||kg||Standard Deviation|Mean
1399660|NCT01265524|Secondary|Weight Loss at Week 1||Baseline and 1 week|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||kg||Standard Deviation|Mean
1399661|NCT01265524|Primary|Change in Serum Potassium|Change in serum potassium from baseline to Week 8.|Baseline and 8 weeks|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.|||mg/dl||Standard Deviation|Mean
1399662|NCT01265511|Secondary|Undetectable HCV RNA||Week 24|Week 24 analysis does not include the 2 placebo subjects because they were discontinued for lack of efficacy before week 24.|||participants|||Number
1399663|NCT01265511|Secondary|Partial Early Virologic Response|Proportion of subjects with detectable HCV RNA that achieve a > or = 2 log reduction in HCV RNA from baseline to Week 12|Week 12||||participants|||Number
1399664|NCT01265511|Secondary|Undetectable HCV RNA||Week 12||||participants|||Number
1399665|NCT01265511|Primary|Undetectable HCV RNA||Week 4||||participants|||Number
1399666|NCT01265498|Secondary|Change in SF-36 Quality of Life Mental Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||units on a scale||Standard Deviation|Mean
1399667|NCT01265498|Secondary|Change in SF-36 Quality of Life Physical Component Summary|Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome.|baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||units on a scale||Standard Deviation|Mean
1399668|NCT01265498|Secondary|Change in Diastolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mm Hg||Standard Deviation|Mean
1399669|NCT01265498|Secondary|Change in Systolic Blood Pressure||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mm Hg||Standard Deviation|Mean
1399670|NCT01265498|Secondary|Change in Waist-to-hip Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||ratio||Standard Deviation|Mean
1399671|NCT01265498|Secondary|Change in Waist Circumference||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||cm||Standard Deviation|Mean
1399672|NCT01265498|Secondary|Change in Body-mass Index||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||kg/m²||Standard Deviation|Mean
1399673|NCT01265498|Secondary|Change in Weight||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||kg||Standard Deviation|Mean
1399674|NCT01265498|Secondary|Change in Glycated Haemoglobin A1c||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/mol||Standard Deviation|Mean
1399675|NCT01265498|Secondary|Change in HOMA-IR||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||glucose[mmol/L]× insulin[pmol/L] / 22.5||Standard Deviation|Mean
1399676|NCT01265498|Secondary|Change in Insulin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||pmol/L||Standard Deviation|Mean
1399677|NCT01265498|Secondary|Change in Fasting Serum Glucose||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399678|NCT01265498|Secondary|Change in International Normalised Ratio||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||ratio||Standard Deviation|Mean
1399679|NCT01265498|Secondary|Change in Prothrombin Time||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||s||Standard Deviation|Mean
1399680|NCT01265498|Secondary|Change in Total Protein||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||gl/L||Standard Deviation|Mean
1399681|NCT01265498|Secondary|Change in Albumin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||gl/L||Standard Deviation|Mean
1399682|NCT01265498|Secondary|Change in Uric Acid||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||μmol/L||Standard Deviation|Mean
1399683|NCT01265498|Secondary|Change in Creatinine||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||μmol/L||Standard Deviation|Mean
1399684|NCT01265498|Secondary|Change in Phosphate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399685|NCT01265498|Secondary|Change in Calcium||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399686|NCT01265498|Secondary|Change in Bicarbonate||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399687|NCT01265498|Secondary|Change in Platelet Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||platelets *10^9 per L||Standard Deviation|Mean
1399688|NCT01265498|Secondary|Change in White Blood Cell Count||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||white blood cells *10^9 per L||Standard Deviation|Mean
1399689|NCT01265498|Secondary|Change in Mean Corpuscular Volume||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||fL||Standard Deviation|Mean
1399690|NCT01265498|Secondary|Change in Haematocrit||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||proportion of 1.0||Standard Deviation|Mean
1399691|NCT01265498|Secondary|Change in Haemoglobin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||g/L||Standard Deviation|Mean
1399692|NCT01265498|Secondary|Change in Triglycerides||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399693|NCT01265498|Secondary|Change in LDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399694|NCT01265498|Secondary|Change in HDL Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399695|NCT01265498|Secondary|Change in Total Cholesterol||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||mmol/L||Standard Deviation|Mean
1399696|NCT01265498|Secondary|Change in Total Bilirubin||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||μmol/L||Standard Deviation|Mean
1399697|NCT01265498|Secondary|Change in γ-glutamyl Transpeptidase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
1399698|NCT01265498|Secondary|Change in Alkaline Phosphatase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
1399699|NCT01265498|Secondary|Change in Asparate Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
1399700|NCT01265498|Secondary|Change in Alanine Aminotransferase||baseline to 72 weeks|All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes.|||U/L||Standard Deviation|Mean
1399701|NCT01265498|Secondary|Portal Inflammation: Change in Score|Change in portal inflammation score. Portal inflammation was assessed on a scale of 0-3, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
1399702|NCT01265498|Secondary|Portal Inflammation: Patients With Improvement|Patients with improvement in portal inflammation score. Portal inflammation was assessed on a scale of 0–2, with higher scores showing more severe portal inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
1399703|NCT01265498|Secondary|Lobular Inflammation: Change in Score|Change in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
1399704|NCT01265498|Secondary|Lobular Inflammation: Patients With Improvement|Patients with improvement in lobular inflammation score. Lobular inflammation was assessed on a scale of 0–3, with higher scores showing more severe lobular inflammation.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
1399705|NCT01265498|Secondary|Steatosis: Change in Score|Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
1399706|NCT01265498|Secondary|Steatosis: Patients With Improvement|Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0–3, with higher scores showing more severe steatosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
1399707|NCT01265498|Secondary|Hepatocellular Ballooning: Change in Score|Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
1399708|NCT01265498|Secondary|Hepatocellular Ballooning: Patients With Improvement|Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0–2, with higher scores showing more severe ballooning.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
1399709|NCT01265498|Secondary|Total NAFLD Activity Score: Change in Score|NAFLD activity score was assessed on a scale of 0–8, with higher scores showing more severe disease (the components of this measure are steatosis [assessed on a scale of 0–3], lobular inflammation [assessed on a scale of 0–3], and hepatocellular ballooning [assessed on a scale of 0–2]).|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||units on a scale||Standard Deviation|Mean
1399710|NCT01265498|Secondary|Fibrosis: Change in Score|Change in fibrosis score. Fibrosis was assessed on a scale of 0–4, with higher scores showing more severe fibrosis.|baseline to 72 weeks||||units on a scale||Standard Deviation|Mean
1399711|NCT01265498|Secondary|Fibrosis: Patient With Improvement|Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0–4, with higher scores showing more severe fibrosis.|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
1399712|NCT01265498|Secondary|Resolution of NASH Diagnosis|Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy|baseline to 72 weeks|Number of patients with biopsy specimens at baseline and 72 weeks|||participants|||Number
1399713|NCT01265498|Primary|Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|"Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as:~No worsening in fibrosis; and~A decrease in NAFLD Activity Score (NAS) of at least 2 points"|baseline to 72 weeks|Number of randomly assigned patients with observed or expected week 72 visit before protocol modified on Jan 6, 2014, to eliminate week 72 biopsy. 11 patients in the placebo group and eight in the obeticholic acid group had missing histological data at week 72, and the results for these patients were imputed as a lack of improvement.|||participants|||Number
1399714|NCT01265459|Secondary|Subject´s Global Assessment of the Status of the Study Knee (Change From Baseline)|"The subject will assess his/her global status how the study knee affects them by using a 11-point numerical rating scale, Subject global assessment scale, from very poor=0 to excellent=10."|26 weeks after treatment compared to baseline||||units on a scale||Standard Deviation|Mean
1399715|NCT01265459|Secondary|WOMAC Physical Function Score (Change From Baseline)|"The study aims to compare the physical function for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) physical function score that consists of 17 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to performing daily physical activities the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline||||units on a scale||Standard Deviation|Mean
1399716|NCT01265459|Secondary|WOMAC Stiffness Score (Change From Baseline)|"The study aims to compare the change of stiffness for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) stiffness score that consists of 2 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much stiffness the subject has experienced in the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline||||units on a scale||Standard Deviation|Mean
1399717|NCT01265459|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability From Baseline to 26 Weeks After Treatment.|"Safety and tolerability will be assessed at each clinic visit (Baseline, 2, 6, 12, 18 and 26 weeks). Standard questions was used, Since your last clinical visit have you had any health problems?”."|From baseline to 26 weeks after treatment||||participants|||Number
1399718|NCT01265459|Primary|Change of Pain Over 26 Weeks (Change From Baseline)|"The study aims to compare the change of pain for different volumes of study product over 26 weeks using WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score that consists of 5 questions.~It is a 5-graded Likert scale: None, Mild, Moderate, Severe or Extreme relating to how much pain the subject has experienced during the last 48 hours. The score of each dimension is calculated by simply adding the score (from 0 to 4) for each question."|26 weeks after treatment compared to baseline|"The primary population for all efficacy evaluations was the ITT population (all subjects randomized and treated with study product).~No imputation of missing data was done. Analyses presented were based on observed cases."|||units on a scale||Standard Deviation|Mean
1399719|NCT01265446|Secondary|Change From Baseline Sore Throat Pain Intensity up to 240 mn Post-dose|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm). It measures the highest pain level felt by the patient.|Baseline and 240 mn post-dose|intent to treat|||mm||95% Confidence Interval|Mean
1399720|NCT01265446|Primary|Change From Baseline Sore Throat Pain Intensity|100 milimeter (mm) visual acuity score (left=no pain=0mm, right=worst possible pain=100mm)|Baseline and 2 hours post-dose|Intent to treat|||mm||95% Confidence Interval|Mean
1399721|NCT01265420|Primary|Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)||30 days after last injection||||participants|||Number
1399722|NCT01265394|Secondary|Measurement of Amyloid Content in Different Parts of the Brain|"Is the computerized measurement of amyloid content in different parts of the brain.~The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.~The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.~The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements."|PET scans performed on patients 90 minutes post Flutemetmol Administration|The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.|||Standard Uptake Value Ratio ( SUVR)||Standard Deviation|Mean
1403103|NCT01236521|Secondary|SF-36 Vitality Scale|The SF-36 vital score is a subscale that assesses participants' vitality/energy. It is scored on a 0 to 100 scale with higher scores representing greater vitality/energy.|baseline||||scores on a scale||Standard Deviation|Mean
1399723|NCT01265394|Primary|Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid|"The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.~The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading)."|PET scans performed on patients 90 minutes post Flutemetmol Administration|Healthy young adult subjects aged 18 to 40 are presumed to be amyloid negative|||Brain Scans Read|||Number
1399724|NCT01265056|Secondary|Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)|The sickness inventory profile (SIP) is a behaviorally based measure of health status. Scores range from 0-68 with higher numbers indicating worse outcomes. The study report total SIP score. The higher the score the worse the function.|First Clinic Follow Up After Discharge||||units on a scale||Standard Deviation|Mean
1399725|NCT01265056|Secondary|Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups|The Brief Symptom Inventory 18 (BSI 18) is designed with reliability in mind. The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders in medical and community populations. As the latest in an integrated series of test instruments that include the SCL-90-R®, BSI® (53 questions), and DPRS® instruments, the BSI 18 test offers a more effective, easy-to-administer tool to help support clinical decision-making and monitor progress throughout treatment. BSI-18 measures three dimensions with 6 questions a piece (somatization , depression , anxiety) and overall psychological distress scores (Global severity index, GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. The GSI score is calculated as the mean of the three subscales. The study reported the GSI score. Higher score is worse.|First Clinic Follow Up After Discharge||||units on a scale||Standard Deviation|Mean
1399726|NCT01265056|Primary|Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)||From time of enrollment to 2 weeks after being discharged|This was an intention to treate analysis. We measured the oral morphine equivalents both groups were administered.|||morphine equivalents||Standard Deviation|Mean
1399727|NCT01264952|Primary|Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)||After operation on day 7||||Toxicity, symptoms|||Number
1399728|NCT01264952|Secondary|Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology||After operation or 1st day after operation, 7th day, 30th day, monthly||||complete response (CR)|Participants||Number
1399729|NCT01264952|Secondary|Clinical Evaluation of the Patient (Pain Scale, Adverse Events, Concomitant Treatment)||After operation on tha days 2, 7, 30, monthly||||patients with non-severe adverse events|||Number
1399730|NCT01264939|Primary|Percentage of Participants With Adverse Events|The percentage of participants with serious adverse events and other adverse events is summarized by MedDRA preferred terms and organ classes in the Reported Adverse Events section below.|Baseline to the end of study (up to 40 weeks)|Safety population: All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1399731|NCT01264939|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|A complete responder was defined as a participant with a UAS7 score = 0 at Week 12. The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
1399732|NCT01264939|Secondary|Percentage of Angioedema-free Days From Week 4 to Week 12|The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days for which a patient responded “No” to the angioedema question in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit.|Week 4 to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis.|||Percentage of days||Standard Deviation|Mean
1399733|NCT01264939|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug and who had a DLQI score at Week 12.|||Units on a scale||Standard Deviation|Mean
1399734|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Size of the Largest Hive Score|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1399780|NCT01264380|Primary|Maximal Observed Plasma Concentration (Cmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.|||µg/mL||Standard Deviation|Mean
1399735|NCT01264939|Secondary|Percentage of Weekly Itch Severity Score MID Responders at Week 12|The percentage of participants with an itch severity score at 12 Weeks at least 5 points lower than at Baseline. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
1399736|NCT01264939|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity.|Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Percentage of participants|||Number
1399737|NCT01264939|Secondary|Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12|The time to the MID response is the number of weeks from the start of treatment (Baseline) until the time point at which the first MID response occurs. The MID response is defined as a reduction ≥ 5 points from Baseline in the weekly itch severity score. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug. Only patients with a MID response were included in the analysis.|||Weeks||95% Confidence Interval|Median
1399738|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Number of Hives Score|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1399739|NCT01264939|Secondary|Change From Baseline to Week 12 in the Urticaria Activity Score Over 7 Days (UAS7)|The UAS7 is the sum of the daily urticarial activity scores over 7 days and ranges from 0 to 42. The daily urticarial activity score is the average of the morning and evening urticarial activity scores and ranges from 0 to 6. The urticarial activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticarial activity scores over the 7 days prior to the first treatment. A higher urticarial activity score indicates more urticaria activity. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1399740|NCT01264939|Secondary|Change From Baseline to Week 12 in the Weekly Itch Severity Score|The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement.|Baseline to Week 12|Modified intent-to-treat population: All randomized patients who received at least 1 dose of study drug.|||Units on a scale||Standard Deviation|Mean
1399741|NCT01264887|Primary|Time Dependence of Adverse Events|The onset and duration of TEAEs was not evaluated for this trial.|Day 1; 144 weeks|||||||
1399742|NCT01264887|Secondary|Tapentadol Prolonged Release Exposure|The number of days that participants took tapentadol prolonged release. The extent of exposure was categorized into 2 periods, less than 90 days and more than 90 days (up to 144 weeks).|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
1399743|NCT01264887|Other Pre-specified|Average Daily Total Tapentadol Prolonged Release Dose|The Total Daily Dose (TDD) on any given day is the sum of the morning and evening intake amounts. The average TDD is an individuals average over the trial period.|Day 1; up to 144 weeks|Safety Set.|||mg per day||Standard Deviation|Mean
1399744|NCT01264887|Other Pre-specified|Average Pain Intensity (Over a Twelve-week Period)|"The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine.~Average pain intensity score is the average of pain experienced for previous 24 hours as rated on an 11-point NRS at each visit. Calculations are based on 3 consecutive planned (at 4-weekly intervals) visits.~All available data of a participant was used; if a participant dropped-out or had incomplete data during a 12-week period no imputations were performed for the missing values."|Day 1; up to Week 144|Safety Set.|||units on a scale||Standard Deviation|Mean
1399745|NCT01264887|Primary|Countermeasures Taken Due to Treatment Emergent Adverse Events|Participant-based analysis of treatment emergent adverse events (TEAEs) regarding countermeasure to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The countermeasure taken by the investigator were reported.|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
1399816|NCT01263717|Primary|Liver Fat|Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.|||Change in hepatic lipid-to-water %||Inter-Quartile Range|Median
1399746|NCT01264887|Primary|Relatedness Assessment of Treatment Emergent Adverse Events|Participant-based analysis of treatment emergent adverse events (TEAEs) regarding the relationship to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The relationship was rated by the investigator. The categorization of relatedness into one of the two categories was based on the following: Related included “possible”, “probable/likely”, and “certain”; whilst unrelated treatment emergent adverse events include those rated by the investigator as “unlikely”, “conditional/unclassified”, “un-assessable/unclassifiable”, and “not related”.|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
1399747|NCT01264887|Secondary|Assess Consumption of Tapentadol During Long Term Use|Summary of the modal total daily dose during the treatment period. The modal dose was based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.|Day 1; up to 144 weeks|"The modal dose is based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.~No participant received more than 500 mg per day."|||participants|||Number
1399748|NCT01264887|Primary|Severity of Adverse Events|"The severity of treatment emergent adverse events was any untoward medical occurrence in a patient administered tapentadol. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the (investigational) medicinal product whether or not related to the use of tapentadol.~The clinical “intensity” of adverse event were classified as:~Mild: signs and symptoms which can be easily tolerated. Symptoms could be ignored and disappeared when the participant is distracted.~Moderate: symptoms caused discomfort but were tolerable, they could not be ignored and affect concentration.~Severe: symptoms affected the usual daily activity."|Day 1; up to 144 weeks|Safety Set.|||participants|||Number
1399749|NCT01264835|Primary|Procedure Duration (Surgery Time)|Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.|Time of surgery|No analyses are being reported for this outcome measure as this trial was terminated early. The procedure was only performed with the slotted anoscope in 1 subject. No assessment or analysis of primary or secondary objectives was performed.|||minutes||Standard Deviation|Mean
1399750|NCT01264770|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
1399751|NCT01264770|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Non-responder imputation applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
1399752|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
1399759|NCT01264770|Secondary|DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
1399753|NCT01264770|Secondary|HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Units on a scale||Standard Deviation|Mean
1399754|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 24. Treatment difference: difference between fostamatinib and adalimumab groups.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Percentage improvement from baseline||Standard Deviation|Mean
1399755|NCT01264770|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 6|ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous. Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Percentage improvement from baseline||Standard Deviation|Mean
1399756|NCT01264770|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
1399757|NCT01264770|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
1399758|NCT01264770|Secondary|Proportion of Patients Achieving ACR20 up to Week 24|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.|6 and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6 and with adalimumab (not placebo) at Week 24.|||Percentage of responders|||Number
1399768|NCT01264614|Primary|Fuld Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Fuld Semantic Recall possible score range is 0-20 points; Fuld Immediate and Delayed Recall possible score range is 0-10).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Points||Standard Deviation|Mean
1399760|NCT01264770|Secondary|DAS28 EULAR Response at Week 6|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.|6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Percentage of responders|||Number
1399761|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. Non-responder imputation has been applied by carrying the baseline observation forward. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with adalimumab (not placebo) at Week 24.|||Units on a scale||Standard Deviation|Mean
1399762|NCT01264770|Primary|DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.|Baseline and 6 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. In line with the study objectives, fostamatinib was compared with placebo (not adalimumab) at Week 6.|||Units on a scale||Standard Deviation|Mean
1399763|NCT01264679|Secondary|Mean Change In TSAT From Baseline To Week 5 And To Week 7|Mean changes in TSAT following the first course of ferumoxytol from Baseline to Week 5 and to Week 7 were to be presented. However, despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5 and Week 7|ITT Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
1399764|NCT01264679|Secondary|Proportion Of Participants With An Increase In Hemoglobin From Baseline To Week 5 And To Week 7|The proportion of participants with an increase hemoglobin to ≥1.0 g/dL or to ≥12.0 g/dL during the period from Baseline to Week 5 and to Week 7 following each course of ferumoxytol was to be presented. However, despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5 and Week 7|ITT Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
1399765|NCT01264679|Primary|Mean Change In Hemoglobin From Baseline To Week 5|Mean changes in hemoglobin following the first course of ferumoxytol from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5|ITT Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
1399766|NCT01264614|Primary|Neurophysiological Function Pre- & Post- Intervention|Resting EEG and ERP recordings before (T1) and after (T2) strengthening exercise intervention|Baseline and 3 months|||||||
1399767|NCT01264614|Primary|Figure Copy & Delayed Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Figure Copy & Delayed possible score range is 0-36 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Points||Standard Deviation|Mean
1399779|NCT01264380|Primary|Minimum Observed (Trough) Plasma Concentration (Cmin) in the Fasted and Fed States|Single dose Pre-dose concentration is referred as Cmin here. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Pre-dose on Periods A and B|PK analysis population.|||µg/mL||Standard Deviation|Mean
1399769|NCT01264614|Primary|Color Trails Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Color Trails possible score range is 0-300 seconds).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Time to complete (seconds)||Standard Deviation|Mean
1399770|NCT01264614|Primary|Digits Backwards Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Higher scores represent better performance (Digits backwards possible score range is 0-14 points).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Points||Standard Deviation|Mean
1399771|NCT01264614|Primary|Stroop Test Performance From Pre- to Post-intervention|Average raw cognitive scores before (T1) and after (T2) strengthening exercise intervention. Lower scores on Stroop C (possible range 0-240 sec) represents better performance).|Baseline and 3 months|Two of 9 normative participants, had to be dropped from analyses due to limited participation in the exercise program (less than once per week on average; health problems and snowy weather were the main limiting factors) and one dementia exerciser was dropped because he did not complete any of the outcome measures.|||Time to complete (seconds)||Standard Deviation|Mean
1399772|NCT01264601|Secondary|Influence of Atopic Co-morbidities on Severe Reactivity to Vaccine as it Was Administered|"Rates of co-morbid allergic disease, size and magnitude of egg skin and ImmunoCAP tests, presence of other food allergy, and tolerance of baked egg will be assessed through a screening questionnaire and chart review, and compared between the groups to assess for any significant differences that may predict TIV tolerance."|6 months|Because no participants had systemic/severe reactivity, there were no participants who were TIV intolerant, and therefore no meaningful analysis of correlation of baseline characteristics to intolerance could be performed. All Baseline Characteristics collected for the original purpose of such correlation are reported in Baseline Characteristics.||||||
1399773|NCT01264601|Primary|Categorical Reactivity to Vaccine as it Was Administered|"After randomization, group 1 will receive a 10%/90% (or 20%/80% for 0.25ml) graded challenge of the age appropriate TIV dose, separated by 30 minutes for observation. Group 2 will receive a first dose consisting of normal saline at a volume equal to 10% of their age appropriate dose, and the second dose will consist of their full age appropriate dose as the 90% equivalent, also separated by 30 minutes of observation. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose. All parties will report any adverse reactions occurring in the next 48 hours after vaccination that were not observed at the time of in office observation."|48 hours||||Participants|||Count of Participants
1399774|NCT01264380|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until death (Up to Week 124)|Data for OS was not collected as there was a change in planned analysis, not to collect the data.||||||
1399775|NCT01264380|Secondary|Percentage of Participants With Best Objective Response (BOR) as Complete Response (CR) or Partial Response (PR)|BOR was defined as the best objective response assessed by investigator during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR was the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation. It is defined as the number of participants whose best objective response was complete response (CR) or partial response (PR) divided by the total number of efficacy evaluable participants. CR: disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes (whether target or non-target) were non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From Baseline then Day 1 of Cycle 3 and 5 (21-day cycle) at Period C thereafter every 2 cycles until Cycle 12 followed by every 4 cycles from Cycle 13 until disease progression or death (Up to Week 124)|Intent-to-treat (ITT) population included participants with measurable disease who received at least 1 dose of vemurafenib. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1399776|NCT01264380|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel) in the Fasted and Fed States|Apparent first-order terminal elimination rate constant (kel), was calculated as the negative slope of the linear regression of the terminal phase in plasma vemurafenib concentration-time profile using specific appropriate time points. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|"PK analysis population. Here number of participants analyzed=participants who were evaluable for this outcome measure."|||1/h||Standard Deviation|Mean
1399777|NCT01264380|Primary|Terminal Elimination Half-Life (t1/2) in the Fasted and Fed States|T1/2 is the time required for the concentration of the drug to reach half of its original value. PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
1399778|NCT01264380|Primary|Time to Reach Maximal Plasma Concentration (Tmax) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population.|||hour||Full Range|Median
1399781|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Sample With Last Measurable Concentration (AUC[0-last]) in the Fasted and Fed States|PK analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||µg*h/mL||Standard Deviation|Mean
1399782|NCT01264380|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0-inf]) in the Fasted and Fed States|Pharmacokinetic (PK) analyses was performed after the completion of Period A and Period B of this study for all participants.|Period A: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 hours (h) post-dose (pd) on Day 1; 24, 36, 48, 72, 96, 144, 192, and 240 h pd and Period B: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16 h pd on Day 11; 24, 36, 48, 72, 96, 144, 192, and 240 h pd|PK analysis population included participants who received both single doses of vemurafenib in Periods A and B without protocol violation and provided adequate PK assessments to calculate important PK parameters. Here “number of participants analyzed”=participants who were evaluable for this outcome measure.|||micrograms*hour per milliliter (µg*h/mL)||Standard Deviation|Mean
1399783|NCT01264081|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|3 years|Three study participants were affected by the adverse events: 2 - who completed the study and 1 who did not complete cycle 1 due to death of progressive disease. The participant who withdrew from study didn't take Lapatinib and experience any adverse events.|||Participants|||Count of Participants
1399784|NCT01264081|Primary|Count of Participants With a Partial Response (PR) and Complete Response (CR) to Lapatinib Who Have Metastatic Melanoma Harboring ERBB4 Mutations.|The count of participants with a partial response and complete response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.|3 years|Only two participants could be evaluated for response and they had SD (none with a PR or CR). Other participants did not reach the evaluation point (i.e. discontinued Lapatinib)as per study protocol, therefore not evaluable.|||Participants|||Count of Participants
1399785|NCT01264016|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)|Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing five tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.|2 hours|Per protocol|||participants|||Number
1399786|NCT01264016|Primary|Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5% to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject's hematocrit measurement was missing, so this subject's blood test data was not evaluable. Since study staff tested each subject's venous blood using 2 lots of test strips, 2x93(or 186) test results were possible.|||percentage of venous bg results|Participants||Number
1399787|NCT01264016|Primary|Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results <75mg/dL) or +/- 5 to 20% (for reference BG results >=75mg/dL) of the reference method results.|2 hours|One subject did not complete capillary blood testing (low blood sugar) and one subject hematocrit measurement was missing. These subjects' blood test data was not evaluable. Since the remaining 92 subjects tested 2 test strip lots on the BGM system, 2x92(184) tests results were possible.|||percentage of BG Results|Participants||Number
1399788|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).~Negative changes show a decrease from Baseline."|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1399814|NCT01263717|Secondary|Intramyocellular Lipid|Intramyocellular lipid (IMCL) as measured by magnetic resonance (MR) spectroscopy of the calf. Soleus IMCL normalized to creatinine (IMCL/Cr based on areas determined by spectroscopy) was measured. The change over 6 months is reported.|6 months|All available data were used; data were not available for some subjects. Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.|||Change in ratio of IMCL/Cr||Inter-Quartile Range|Median
1399789|NCT01263925|Secondary|Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1|"Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor).~Negative changes show a decrease from Baseline."|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS). For each subscale of the questionnaire, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1399790|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399791|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399792|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399793|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399794|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399795|NCT01263925|Secondary|Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399796|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399797|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399815|NCT01263717|Primary|Visceral Adipose Tissue|Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.|6 months|Data from 1 patient who was discontinued between the 3 and 6mo visits for adverse event are included. These data were obtained at a termination visit.|||change in cm^2 after 6 months||95% Confidence Interval|Mean
1399798|NCT01263925|Secondary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399799|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Daily Treatment (Period 1)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399800|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 6-months Follow-up (Period 3)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399801|NCT01263925|Primary|Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline|The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.|From Baseline to the end of 4 weeks of Interval Treatment (Period 2)|Full Analysis Set (FAS).|||meter/meter||Standard Deviation|Mean
1399802|NCT01263873|Primary|Ease of Intubation, as Measured by an Ease of ETT Insertion Score.|To measure the ease of intubation, an ease of ETT insertion score was obtained by using a 100 millimeter visual analog scale done by the anesthesia provider doing the intubation. The score of 0 millimeters was the easiest intubation and a score of 100 millimeters was the hardest intubation done by that anesthesia provider.|Participants were followed for the duration of intubation, an average of 10 minutes||||Visual Analog Score in millimeters||Standard Deviation|Mean
1399803|NCT01263873|Primary|Ease of Intubation, as Measured by Number of ETT Redirections|To measure the ease of intubation, once the airway structure was visualized with the GlideScope, the number of ETT redirections at the glottis to intubate the trachea was counted by video recordings by the PI.|Participants were followed for the duration of intubation, an average of 10 minutes||||Number of redirections to place ETT||Standard Deviation|Mean
1399804|NCT01263873|Primary|Ease of Intubation, as Measured by Time in Seconds for ETT Insertion|To measure the ease of intubation by time in seconds for ETT insertion. Time was measured in seconds and started when the anesthesia provider asked for the ETT and stopped once the ETT was placed through the glottis. The time was obtained from video recordings during the intubation by the principal investigator (PI).|Participants were followed for the duration of intubation, an average of 10 minutes||||Seconds||Standard Deviation|Mean
1399805|NCT01263717|Secondary|Hemostatic Markers|Tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) measured in serum.|6 months|Please note that we do not have data for these markers (neither PAI1 or tPA) because we did not have adequate funds to assess these.||||||
1399806|NCT01263717|Secondary|Adiponectin|adiponectin.|6 months|All available data were used. Data were not available for 1 subject.|||Change in ng/mL||Inter-Quartile Range|Median
1399807|NCT01263717|Secondary|Glucose Tolerance|Glucose tolerance as measured by standard oral glucose tolerance test. 2-hour glucose is given.|6 months|All available data were used; data were not available for some subjects.|||Change in 2-hour glucose, mg/dL||95% Confidence Interval|Mean
1399808|NCT01263717|Secondary|Carotid Intimal Medial Thickness (cIMT)|Carotid Intimal Medial Thickness (cIMT).|6 months|All available data were used.|||Change in mm||95% Confidence Interval|Mean
1399809|NCT01263717|Secondary|Lipid Panel|Fasting lipids. Triglyceride value is given.|6 months|All available data were used; data were not available for one subject.|||Change in triglyceride, mg/dL||Inter-Quartile Range|Median
1399810|NCT01263717|Secondary|Insulin Like Growth Factor 1 (IGF-I)|Insulin Like Growth Factor 1 (IGF-I).|6 months|All available data were used; data were not available for one subject.|||Change in ng/mL||Standard Deviation|Mean
1399811|NCT01263717|Secondary|HbA1c|Hemoglobin A1c.|6 months|All available data were used; data were not available for one subject.|||Change in %||95% Confidence Interval|Mean
1399812|NCT01263717|Secondary|Insulin Sensitivity|In a subgroup of 1/2 of the subjects, euglycemic hyperinsulinemic clamp will be performed to assess insulin-stimulated glucose uptake. Insulin stimulated glucose uptake (M) calculated using the method of DeFronzo is shown.|6 months|All available data were used; data were not available for some subjects.|||Change in mg/kg/min||95% Confidence Interval|Mean
1399813|NCT01263717|Secondary|Endogenous Growth Hormone Secretion|Endogenous growth hormone (GH) concentrations measured by overnight frequent blood sampling every 20 minutes. Mean overnight GH concentration is given.|6 months|All available data were used; data were not available for some subjects.|||Change in ng/mL||Inter-Quartile Range|Median
1399843|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
1399817|NCT01263704|Secondary|Quality of Life (QoL): Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire|The FACIT-F questionnaire consists of 13 questions with a total score range of 0 to 52 with 0 indicating a better outcome and 52 indicating a worse outcome.|[Visit 1 (Screening, Week 0), at Visits 11 (Week 45) and 14 (Week 80) and at the end of the study (Month 42)]|Efficacy analysis population included all participants who received rituximab during the study. Participants from the efficacy analysis population, who completed the FACIT-F questionnaire at any time point during the study, were analyzed as indicated at each time point.|||score on a scale||Standard Deviation|Mean
1399818|NCT01263704|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval from the first study drug treatment day to the first sign of disease progression according to NCI-WG guidelines. Progressive disease (PD): Any new lesion, any disease symptoms, >/=50% increase in lymphadenopathy, splenomegaly, hepatomegaly, >/= 50% increase in the number of circulating clonal B lymphocytes, decrease of hemoglobin levels by > 2.0 g/dL, >/= 50% decrease of platelet counts, increase of lymphocytes in bone marrow to more than 30% from normal.|Up to 53 months|Efficacy analysis population included all participants who received rituximab during the study.|||months||95% Confidence Interval|Median
1399819|NCT01263704|Secondary|Hospitalization Days||Up to 53 months|The safety population included all enrolled participants.|||days||Full Range|Median
1399820|NCT01263704|Secondary|Percentage of Participants With Neutropenic Fever, Infection, >/= Grade 3 Drug-Related Neutropenia, >/= Grade 3 Drug-Related Thrombocytopenia, Hospitalizations||Up to 53 months|The safety population included all enrolled participants.|||percentage of participants|||Number
1399821|NCT01263704|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. Preexisting conditions which worsen during a study are also considered as adverse events. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution, and fulfills any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|Up to 53 months|The safety population included all enrolled participants.|||percentage of participants|||Number
1399822|NCT01263704|Primary|Overall Response Rate|Overall response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to National Cancer Institute - Working Group [NCI-WG] guidelines. CR: no clonal B lymphocytes in peripheral blood, no significant lymphadenopathy, liver and spleen normal size, no disease symptoms, blood counts: absolute neutrophil count (ANC) >1,500/microliter (mcL), platelets > 100,000/mcL, hemoglobin > 11.0 grams/deciliter (g/dL), normocellular bone marrow. PR: >/= 50% decrease in clonal B lymphocyte count, >/= 50% reduction in lymphadenopathy, >/= 50% reduction of liver or spleen enlargement and ANC >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 11.0 g/dL OR >/= 50% increase in ANC, platelets or hemoglobin.|Up to 42 months|Efficacy analysis population included all participants who received rituximab during the study.|||percentage of participants||95% Confidence Interval|Number
1399823|NCT01263691|Secondary|TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).|||geometric mean titer||95% Confidence Interval|Geometric Mean
1399824|NCT01263691|Secondary|Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).|||days||Full Range|Median
1399825|NCT01263691|Primary|Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.~Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56||||percentage of participants|||Number
1399844|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
1399826|NCT01263691|Primary|Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events|"Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood.~Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56."|Days 0-56||||participants|||Number
1399827|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||percentage of participants|||Number
1399828|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||participants|||Number
1399829|NCT01263691|Primary|Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 - 101.5°F~Grade 2: 101.6 - 102.9°F ;~Grade 3: 103.0 - 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||percentage of participants|||Number
1399830|NCT01263691|Primary|Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)|"Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events.~Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.”~Toxicity grades for fever were derived from body temperature using the following scale:~Grade 0: <100°F~Grade 1: 100.0 – 101.5°F~Grade 2: 101.6 – 102.9°F ;~Grade 3: 103.0 – 105.0°F~For all other systemic reactions, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||Participants|||Number
1399831|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||Percentage of Participants|||Number
1399845|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
1399846|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
1399832|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 14-20||||Participants|||Number
1399833|NCT01263691|Primary|Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||Percentage of Participants|||Number
1399834|NCT01263691|Secondary|Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.|Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.|Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.|Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).|||geometric mean titer||95% Confidence Interval|Geometric Mean
1399835|NCT01263691|Primary|Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)|"Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0).~All local reactions collected by subjects on diary cards were recorded as adverse events.~Severity of ISR was assessed using a grading scale based on FDA Guidance “Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.”~Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows:~Grade 0: none~Grade 1: <3 cm~Grade 2: 3 to 10 cm~Grade 3: >10 cm~For all other ISRs, the following scale was used:~Grade 0: not present~Grade 1: present with no limitation of activity~Grade 2: interfering with daily activities or requiring non-narcotic treatment~Grade 3: preventing normal daily activities or requiring narcotic analgesia"|Days 0-6||||Participants|||Number
1399836|NCT01263665|Primary|Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure||30 Days post-procedure||||participants|||Number
1399837|NCT01263665|Primary|Successful Completion of the Assigned Treatment|Successful completion of the assigned treatment and postdeployment > stent length (of the first deployed 25 cm GORE > VIABAHN Endoprosthesis with PROPATEN Bioactive Surface) > being within 10% of pre-deployment stent length.|Evaluated immediately after the index procedure||||percentage of subjects|||Number
1399838|NCT01263639|Primary|"Patient Satisfaction as Measured by Giving an Excellent Score on a 5-point Rating"|Within 2 weeks of discharge from the hospital, but before the patient’s first clinic visit, each group will be called by the Professional Resource Group as part of regular quality improvement by the Vanderbilt Medical Center Department of Strategic Development. The patients will be asked a series of questions aimed at determining overall patient satisfaction based on interactions with the attending orthopaedic trauma surgeon.|within 2 weeks of discharge and before first clinic appointment||||participants|||Number
1399839|NCT01263561|Secondary|Complications|Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.|1 year post surgery||||participants|||Number
1399840|NCT01263561|Primary|Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication||1 year post surgery||||percentage of participants|||Number
1399841|NCT01263561|Primary|Intraocular Pressure||1 year post surgery||||mmHg||Standard Deviation|Mean
1399842|NCT01263509|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||pg•hr/mL||Standard Deviation|Mean
1399886|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399847|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
1399848|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
1399849|NCT01263509|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||ng•hr/mL||Standard Deviation|Mean
1399850|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
1399851|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
1399852|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
1399853|NCT01263509|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||μU•hr/mL||Standard Deviation|Mean
1399854|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
1399855|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
1399856|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
1399857|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg•hr/dL||Standard Deviation|Mean
1399858|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399859|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399860|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399861|NCT01263509|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399862|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399863|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399864|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399865|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399866|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399867|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399868|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399869|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399870|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399871|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399872|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399873|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399874|NCT01263509|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399875|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399876|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399877|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399878|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399879|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399880|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399881|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399882|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399883|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399884|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399885|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399887|NCT01263509|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399888|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399889|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399890|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399891|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399892|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399893|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399894|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399895|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399896|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399897|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399898|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399899|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399900|NCT01263509|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399901|NCT01263509|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set|||participants|||Number
1399902|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
1399903|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
1399904|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
1399905|NCT01263496|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.|||pg·hr/mL||Standard Deviation|Mean
1399906|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
1399907|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
1399908|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
1399909|NCT01263496|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Values are Summary Statistics.|||μU·hr/mL||Standard Deviation|Mean
1399910|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).|The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
1399911|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).|The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
1399912|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).|The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
1399913|NCT01263496|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).|The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||ng·hr/mL||Standard Deviation|Mean
1399914|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
1399915|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
1399916|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
1399917|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg·hr/dL||Standard Deviation|Mean
1399918|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).|The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399919|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).|The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399920|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).|The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399921|NCT01263496|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).|The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399922|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Final Visit).|The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399923|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 52).|The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399924|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 48).|The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399925|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 44).|The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399926|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 40).|The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399927|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 36).|The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399928|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 32).|The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399929|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 28).|The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399930|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 24).|The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399931|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 20).|The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399932|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 16).|The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399933|NCT01263496|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||ng/mL||Standard Deviation|Mean
1399934|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Final Visit).|The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399935|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 52).|The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399936|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 48).|The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399937|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 44).|The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399938|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 40).|The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399939|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 36).|The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399940|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 32).|The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399941|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 28).|The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399942|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 24).|The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399943|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 20).|The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399944|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 16).|The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399945|NCT01263496|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.|Baseline and Week 12|Values are Summary Statistics.|||mg/dL||Standard Deviation|Mean
1399946|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Final Visit).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Final Visit (up to Week 52).|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399947|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 52).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399948|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 48).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.|Baseline and Week 48.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399949|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 44).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.|Baseline and Week 44.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399950|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 40).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.|Baseline and Week 40.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399951|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 36).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.|Baseline and Week 36.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399952|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 32).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.|Baseline and Week 32.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399953|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 28).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.|Baseline and Week 28.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399954|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 24).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.|Baseline and Week 24.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399955|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 20).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.|Baseline and Week 20.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399956|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 16).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.|Baseline and Week 16.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399957|NCT01263496|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Values are Summary Statistics.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1400343|NCT01260896|Primary|AUC0-inf of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1399958|NCT01263496|Primary|Number of Participants With Adverse Events.|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date – last dose date >30) will be listed, but not included in the summary tables below.|52 Weeks.|Adverse Event Profile in the Safety Analysis Set|||participants|||Number
1399959|NCT01263483|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.|||pg·hr/mL||Standard Deviation|Mean
1399960|NCT01263483|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||ng·hr/mL||Standard Deviation|Mean
1399961|NCT01263483|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12|Values are from the Full Analysis Set.|||μU·hr/mL||Standard Deviation|Mean
1399962|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg·hr/dL||Standard Deviation|Mean
1399963|NCT01263483|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399964|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1399965|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1399966|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1399967|NCT01263483|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1399968|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399969|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399970|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399971|NCT01263483|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399972|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399973|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399974|NCT01263483|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399975|NCT01263483|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399976|NCT01263470|Secondary|Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).|The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||pg·hr/mL||Standard Deviation|Mean
1399977|NCT01263470|Secondary|Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).|The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng·hr/mL||Standard Deviation|Mean
1399978|NCT01263470|Secondary|Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).|The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.|Baseline and Week 12|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||μU·hr/mL||Standard Deviation|Mean
1399979|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg·hr/dL||Standard Deviation|Mean
1399980|NCT01263470|Secondary|Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).|The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399981|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 12).|The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1399982|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 8).|The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1400037|NCT01262898|Secondary|Apparent Terminal Elimination Half-life (t1/2) at Specified Time Points|This outcome measure was not analyzed in results.|The parameter was planned to be analyzed using samples collected at Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however, the data for this outcome measure was not collected.|PK Population. The data for this outcome measure was not collected.||||||
1399983|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 4).|The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1399984|NCT01263470|Secondary|Change From Baseline in Fasting C-peptide (Week 2).|The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||ng/mL||Standard Deviation|Mean
1399985|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 12).|The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399986|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 8).|The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399987|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 4).|The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399988|NCT01263470|Secondary|Change From Baseline in Fasting Plasma Glucose (Week 2).|The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.|Baseline and Week 2|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1399989|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 8).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.|Baseline and Week 8.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399990|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 4).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.|Baseline and Week 4.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399991|NCT01263470|Secondary|Change From Baseline in Glycosylated Hemoglobin (Week 2).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.|Baseline and Week 2.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399992|NCT01263470|Primary|Change From Baseline in Glycosylated Hemoglobin (Week 12).|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 12.|Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
1399993|NCT01263444|Secondary|Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.|Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||percentage of participants|||Number
1399994|NCT01263444|Secondary|Mean Change From Baseline in IOP at Week 4|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 4|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||mmHg||Standard Deviation|Mean
1399995|NCT01263444|Secondary|Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||mmHg||Standard Deviation|Mean
1399996|NCT01263444|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.|Baseline, Week 12|This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.|||mmHg||Standard Deviation|Mean
1399997|NCT01263301|Primary|no Change of Vertebral Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|2 years|as above explained|||participants|||Number
1399998|NCT01263301|Primary|Change of Vertebral Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of vertebral arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the vertebral arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of vertebral flow pattern when the flow is stopped in the arm by cuff test.|two year|determined as above explained|||participants|||Number
1399999|NCT01263301|Primary|no Change of Subclavian Arterial Flow During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|one year|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.|||participants|||Number
1400000|NCT01263301|Primary|Change of Subclavian Flow to Normal Flow Pattern During Cuff Test|we used carotid duplex duplex to study the change of subclavian arterial flow during cuff test to see if there is any difference between normal participants and patients under hemodialysis. There are two patterns seen. One is that the subclavian arterial flow reversed to normal flow pattern during cuff test. The other is that there is no change of subclavian flow pattern when the flow is stopped in the arm by cuff test.|two years|for there are not too many patients who have subclavian steal found by carotid duplex, we just collected all patients during the study period that have subclavian steal and all patients with vascular access that signed written consent for the examination.|||participants|||Number
1400001|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 6 (Week 4)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
1400002|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 5 (Week 3)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 5 (Week 3)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
1400003|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 4 (Week 2)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 4 (Week 2)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
1400004|NCT01263132|Secondary|Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire|SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.|Visit 2 (Baseline) to Visit 6 (Week 4)|PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same. Two participants in the MF0434 + Gabapentin group had missing values and hence are not included.|||Units on a Scale||Standard Deviation|Mean
1400005|NCT01263132|Primary|Mean Neuropathic Pain Score at Visit 3 (Week 1)|Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.|Visit 3 (Week 1)|Per Protocol (PP) population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study Intention to treat (ITT) and PP populations were the same.|||Units on a Scale||Standard Deviation|Mean
1400006|NCT01263054|Secondary|Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit|"ODI - score range = 0 - 100. 0 corresponds to no disability and 100 indicates the maximum disability possible. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 Months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
1400007|NCT01263054|Secondary|Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit|"PGIC - score range = 1 - 7. 1 corresponds to very much improved and 7 indicates very much worse pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Six subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Error|Mean
1400008|NCT01263054|Secondary|Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit|"BDI - score range = 0 - 63. 0 corresponds to minimal depression and 63 indicates severe depression. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and eight subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
1400009|NCT01263054|Secondary|Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit|"EQ-5d VAS - score range = 0 - 100. 0 corresponds to the worst imaginable health state and 100 indicates the best imaginable health state. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
1400010|NCT01263054|Secondary|Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit|"Short Form 36-PF - score range = 0 - 100. 0 corresponds to greatest disability and 100 indicates no disability. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and seven subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
1400011|NCT01263054|Secondary|Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months||||percentage of study group|||Number
1400012|NCT01263054|Primary|Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.|"Visual Analog Scale (NRS) - score range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|Baseline and 6 months|Five subjects in the TransDiscal System study arm, and six subjects in the Medical Management study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
1400013|NCT01263028|Secondary|Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders||24 Weeks|||||||
1400014|NCT01263028|Secondary|Change in Iron Supplementation||24 Weeks|||||||
1400015|NCT01263028|Secondary|Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels||24 Weeks|||||||
1400016|NCT01263028|Secondary|Change in Inflammatory Markers||24 Weeks|||||||
1400017|NCT01263028|Primary|Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements||24 Weeks|||||||
1400018|NCT01263015|Secondary|Change From Baseline in the Symptom Bother Score (SBS) at Week 4 Through Week 48|"The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, “I do not have this symptom”; 1, It doesn’t bother me”; 2, “It bothers me a little”; 3, “It bothers me”; 4, It bothers me a lot. Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS."|Baseline and Week 4 through 48|ITT-E Population. Participants with missing bother item scores at Week 4 had their last observation carried forward (LOCF). Only those participants contributing to the model (i.e., without missing response variables after LOCF or covariates) were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1400019|NCT01263015|Secondary|Number of Participants With the Indicated Genotypic Resistance With Virological Failure (VF) Through 144|Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG.|Through Week 144|PDVF Genotypic Population: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF|||Participants|||Number
1400027|NCT01263015|Secondary|Time to Viral Suppression (<50 c/mL)|Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population|||Days||95% Confidence Interval|Median
1400344|NCT01260896|Primary|AUC0-t of Venlafaxine.|Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1400020|NCT01263015|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical and Hematology Toxicities at Week144|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death.|From Baseline until Week 144|Safety Population: all participants who received at least one dose of investigational product|||Participants|||Number
1400021|NCT01263015|Secondary|Number of Participants With the Indicated Post-baseline HIV-associated Conditions and Progression, Excluding Recurrences at Week 144|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline until Week 144|ITT-E Population|||Participants|||Number
1400022|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population|||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
1400023|NCT01263015|Secondary|Change From Baseline in CD4+ Cell Counts at Week 144|Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured.|Baseline and Week 144|ITT-E Population|||cells per millimeters cubed (cells/mm^3)||Standard Deviation|Least Squares Mean
1400024|NCT01263015|Secondary|Change From Baseline in Plasma HIV-1 RNA at Weeks 2, 4, 8, 12, 16, 24, 32, 40,48, 60, 72, 84, 96, 108, 120, 132 and 144|Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles).|Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144|ITT-E Population|||log10 copies/mL||Standard Deviation|Mean
1400025|NCT01263015|Secondary|Number of Participants With a Confirmed Plasma HIV-1 RNA Level >=1000 c/mL at or After Week 16 and Before Week 24, or a Confirmed Plasma HIV-1 RNA Level >=200 c/mL at or After Week 24|Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits.|From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)|ITT-E Population|||Participants|||Number
1400026|NCT01263015|Secondary|Percentage of Participants With Plasma Human Immunodeficiency Virus -1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 96 and Week 144|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 96 and Week 144|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
1400028|NCT01263015|Primary|Proportion of Subjects Responding Based on Plasma HIV-1 RNA <50 c/mL at Week 48|The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window.|Week 48|Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
1400029|NCT01262989|Primary|Cmax|Cmax is defined as the maximum or “peak” concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
1400030|NCT01262989|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study|||ng/h/ml||Standard Deviation|Mean
1400031|NCT01262989|Primary|AUC0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)|Participants who completed the study|||ng per hour per ml (ng/h/ml)||Standard Deviation|Mean
1400032|NCT01262898|Secondary|Change From Baseline in Whole Bowel Transit Time, 100 % Gastric Emptying Time (Truncated at 240 Minutes), Small Bowel Transit Time, Colonic Transit Time as Determined by Wireless Motility Capsule (WMC)|WMC is an ingestible telemetric capsule which measures pH, pressure and temperature to assess total gastric emptying time, small and large bowel transit time, colonic transit time, and whole gut transit time. The WMC was ingested immediately following the standard test meal for the oral breath test. Data was collected on a data logger, which was worn on a belt clip. The WMC passed naturally in the participant’s stools between 2 and 5 days after ingestion. The parameters Whole bowel transit time, 100 % gastric emptying time (truncated at 240 minutes), small bowel transit time, colonic transit time were analyzed. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline(Screening i.e., Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||minutes||Standard Deviation|Mean
1400033|NCT01262898|Secondary|Change From Baseline in Upper Gastrointestinal (GI) Symptoms as Assessed by Total Gastrointestinal Cardinal Symptom Index – Daily Diary (GCSI–DD)|GCSI–DD was measured on a 6-point scale. The Total GCSI-DD score was the mean of the following three subscales: Nausea/Vomiting Subscale = mean (nausea, retching, vomiting), Fullness/Early Satiety Subscale = mean (feeling excessively full after meals, not able to finish a normal-sized meal, stomach fullness, loss of appetite), Bloating Subscale = mean (bloating, stomach or belly visibly larger). Each subscale was scored on a severity scale of 0 (none) to 5 (very severe), with lower scores representing less symptom severity. The change from Baseline to each study week in average score was derived and if it improved by 1 point or more, that participant was defined as “responder” for that symptom and on that particular week. Baseline was Screening2/Baseline values (Day -30 to -1). Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Up to 14 days post last dose (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1400034|NCT01262898|Secondary|Daily Average Stool Consistency|Stool consistency was determined on a scale of 1 to 5 (1 = Very hard, 2 = Hard, 3 = Formed, 4 = Loose, 5 = Watery). Following dosing with study medication, stool monitoring was performed up to Day 28. Participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.|Up to Week 4 (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.|||Bowel Movements/ 24 hours||Standard Deviation|Mean
1400035|NCT01262898|Secondary|Daily Bowel Movement Frequency|Daily bowel movement frequency analyzed number of times passed stools in 24 hours of duration. Following dosing with study medication, stool monitoring was performed up to Day 28. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.|Up to Week 4 (Day 28)|All Subjects Population. Only those participants available at specified time points were analyzed.|||Bowel movements/24 hours||Standard Deviation|Mean
1400036|NCT01262898|Secondary|Time to First Bowel Movement After First Dose|The time to first bowel movement was calculated as the time of the first bowel movement after the first dose in hours (floored) for each participant. If a participant had fewer than 5 days worth of data then the daily mean for that week was set to missing for the following two parameters: Bowel Movement Count and Stool Consistency. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics of time to first bowel movement.|Up to Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||hours||Standard Deviation|Mean
1400235|NCT01262339|Primary|Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.||26 weeks|Study was closed prematurely as principal investigator left the University of Wisconsin. Insufficient data for outcome measures analysis. Data was not entered into tabular format. Study closed and records archived.||||||
1400038|NCT01262898|Secondary|Apparent Volume of Distribution (V/F) at Specified Time Points|The apparent volume of distribution V/F = CL/F × MRT, where MRT is the mean residence time. The parameter was planned to be analyzed using samples collected at Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however, the data for this outcome measure was not collected.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK Population. The data for this outcome measure was not collected.||||||
1400039|NCT01262898|Secondary|Apparent Clearance Following Oral Dosing (CL/F) at Specified Time Points|CL/F was calculated as dose/AUC. The parameter was planned to be analyzed from samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however the data for this outcome measure was not collected.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK Population. The data for this outcome measure was not collected.||||||
1400040|NCT01262898|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ct) at Specified Time Points|Analysis of pre-dose (trough) concentration at the end of the dosing interval (Ct) was planned to be performed from the samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population.|||Liters||Standard Deviation|Mean
1400041|NCT01262898|Secondary|Time of Occurrence of Cmax (Tmax) at Specified Time Points|Tmax is defined as the time to reach the observed maximum concentration. Samples were collected at the following times: Tmax was determined directly from the raw concentration-time data. Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population. Only those participants available at specified time points were analyzed.|||Hour||Standard Deviation|Mean
1400042|NCT01262898|Secondary|Maximum Observed Concentration (Cmax) at Specified Time Points|Cmax is defined as the maximum observed drug concentration after administration. Cmax was determined directly from the raw concentration-time data. Samples were collected at the following times: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|PK population. Only those participants available at specified time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1400043|NCT01262898|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration AUC(0-t) at Specified Time Points|AUC(0-t) was derived from GSK962040 plasma concentration-time data. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.Only participants who received GSK962040 drug were analyzed.|Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28|The ‘Pharmacokinetic (PK) Population' was defined as participants in the ‘All subjects’ population for whom a PK sample was obtained and analyzed. Only those participants available at specified time points were analyzed.|||Nanograms.hour/milliliter (ng.h/mL)||Geometric Coefficient of Variation|Geometric Mean
1400044|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Red Blood Cell Count, Reticulocytes|Red Blood Cell count, Reticulocytes measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Tera (10^12) cells per liter (TI/L)||Standard Deviation|Mean
1400045|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Volume|Mean Corpuscle Volume measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
1400046|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Hemoglobin, Mean Corpuscle Hemoglobin Concentration|Hemoglobin, Mean Corpuscle Hemoglobin concentration measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||g/L||Standard Deviation|Mean
1400047|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Hemoglobin|Mean Corpuscle Hemoglobin measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Picograms (Pg)||Standard Deviation|Mean
1400048|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Hematocrit|Hematocrit measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1400049|NCT01262898|Secondary|Mean Change From Baseline in Hematology Parameters : Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet Count, White Blood Cell Count|Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet count, White Blood cell count measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Giga (10^9) cells per liter (GI/L)||Standard Deviation|Mean
1400069|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400050|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry : Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon Dioxide Content/Bicarbonate|Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon dioxide content/Bicarbonate measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
1400051|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry : Albumin, Total Protein|Albumin, Total Protein measurements were taken at Baseline (Day 1 pre-dose), and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose) and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1400052|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid|Direct Bilirubin, Total Bilirubin, Creatinine, Uric acid measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Unit moles per litre (UMOL/L)||Standard Deviation|Mean
1400053|NCT01262898|Secondary|Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase|Alkaline phosphatase, alanine amino transferase, aspartate amino transferase, gamma glutamyl transferase, creatine kinase, lactate dehydrogenase measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
1400054|NCT01262898|Secondary|Number of Participants Outside the Normal Range for 12-lead ECG|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The CCR for ECG parameters were: PR interval (<110 and >220), QRS interval (<75 and >110), Absolute QTc interval (>450 to =< 480) respectively. Baseline was the pre-dose reading for Day 1. Data for abnormal- clinically significant (ACS) and abnormal- not clinically significant (ANCS) has been presented.|Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Participants|||Number
1400055|NCT01262898|Secondary|Number of Participants Outside the Normal Range for Heart Rate|Heart rate measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The CCR for heart rate was Increase or decrease by less than or equal to (>=) 15 and >= 30. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.|Screening2/Baseline (Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Participants|||Number
1400056|NCT01262898|Secondary|Number of Participants Outside the Normal Range for SBP and DBP|Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The clinical concern range (CCR) for SBP was greater than (<) 85 and less than (>) 160 and for DBP the range was <45 and >100. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.|Screening2/Baseline (Day -30 to -1), Day 1 and 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Participants|||Number
1400057|NCT01262898|Secondary|Change From Baseline in Electrocardiography Parameters (12-lead ECG)|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The Baseline value was the Day 1 pre-dose value. ECG parameters included PR interval, QRS duration, QT interval, QTcB, QTcF and RR interval.|Baseline, Day 1 and Day 28|All Subjects Population. Only those participants available at specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
1400058|NCT01262898|Secondary|Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position|Heart rate measurements were taken at pre-dose and 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values . Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population. Only those participants available at specified time points were analyzed.|||Beats per minute (BPM)||Standard Deviation|Mean
1400059|NCT01262898|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position|Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population. Only those participants available at specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1400060|NCT01262898|Secondary|Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Data for on-treatment adverse events is reported.|Up to follow-up (5-10 days post last dose)|All Subjects population.|||Participants|||Number
1400068|NCT01262872|Secondary|Number of Subjects With Acquisition of Haemophilus Influenzae Strains Identified With Polymerase Chain Reaction Differentiation in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400061|NCT01262898|Primary|Gastric Half Emptying Time (GEt1/2)|Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 28, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes(min) later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.|Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28|The ‘All Subjects Population’ compromised of all participants who received at least one dose of study medication. Only those participants available at specified time points were analyzed.|||Minutes||Standard Deviation|Mean
1400062|NCT01262872|Other Pre-specified|Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of PhtD Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Percentage of protein identity|||Number
1400063|NCT01262872|Other Pre-specified|Number of Samples With PhtD Protein Variants in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|"Because of high variants heterogeneity in each group (no major variant), the impact of vaccination on variant prevalence was not analysed.~PhtD sequences were detected in some samples but no consensus sequence could be obtained they were defined as mixed sequences (Mix).~The samples without gene detected were considered as negative for PhtD (PhtD negative)."|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
1400064|NCT01262872|Other Pre-specified|Percentage (Median and Mean) of Protein Identity Relative to Amino Acid Sequence of Ply Protein in the Vaccine for a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|Protein sequence identity was compared to vaccine sequence. Mean and median was calculated and expressed as percentage.|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Percentage of protein identity|||Number
1400065|NCT01262872|Other Pre-specified|Number of Samples With Ply Protein Variants Classified by Number of Amino Acids (AA) Mutation Versus Vaccine Sequence in a Subset of Non-Vaccine-Type S.Pneumoniae Isolates From Nasopharyngeal Swabs – Cohort 2|"Overall, 18 different Ply protein sequences were identified: 5 protein variants previously described (e.g. variants 1, 2, 7, 11 and 15), plus 13 new protein variants which are referred to as variants GSK21 to GSK33. The number of Amino Acids (AA) mutation versus vaccine sequence has been specified for each Ply variant.~The samples without gene detected were considered as negative for Ply (Ply negative)."|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) and Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
1400066|NCT01262872|Other Pre-specified|Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the PhtD Gene – Cohort 2|Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
1400067|NCT01262872|Other Pre-specified|Description of Non-Vaccine-Type S.Pneumoniae Samples Isolated From Nasopharyngeal Swabs Before and After Vaccination for the Ply Gene – Cohort 2|Isolates from the Prev13_3D group were not selected. Samples were distributed evenly in the 5 groups and across time points: 10 isolates from pre-vaccination, 20 at Month 3, 20 at Month 7 and 20 at Month 10. Only samples displaying non-vaccine and non-vaccine related serotypes (all serotypes except serotypes 1, 4, 5 and 14 and serotypes belonging to the serogroups 6, 7, 9, 18, 19 and 23) were selected in systematic (equal number across groups) but non-random manner. Samples were described as follows: samples with gene detected (Positive isolates) with sequenced protein, number of protein Variants, number of isolates with Variant 1 (100% identity with vaccine sequence).|At Month 0 (Pre-vaccination), Month 3 (1 month [m] post-dose [P] III-3+0 schedule or PII–2+1 schedule), Month 7 (5 m PIII - 3+0 schedule or PII–2+1 schedule) or at Month 10 (8 m PIII - 3+0 schedule or 3 m post-booster–2+1 schedule)|The analysis was performed on vaccinated subjects with at least one vaccine administration documented for which S. pneumoniae isolates samples were selected for ply and phtD gene sequencing.|||Samples|||Number
1400070|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400071|NCT01262872|Secondary|Number of Subjects With Acquisition of Any New Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400072|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400073|NCT01262872|Secondary|Number of Subjects With Acquisition of Non-vaccine Serotypes/Serogroups of Streptococcus Pneumoniae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400074|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400075|NCT01262872|Secondary|Number of Subjects With Staphylococcus Aureus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400076|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400077|NCT01262872|Secondary|Number of Subjects With Group A Streptococcus in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed.This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400078|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400079|NCT01262872|Secondary|Number of Subjects With Moraxella Catarrhalis in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Positive cultures of other bacterial pathogens [such as S. aureus, Streptococcus pyogenes (Group A streptococci) and Moraxella catarrhalis] identified in the nasopharynx were analyzed. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400080|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400081|NCT01262872|Secondary|Number of Subjects With Haemophilus Influenzae in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400082|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400083|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Synflorix Related Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Related serotype = any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for the analyses of carriage of S. pneumoniae cross-related serotypes. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400084|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400085|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (10Pn-PD-DiT Vaccine Serotypes) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. A Streptococcus. Pneumoniae (S. pn). vaccine pneumococcal serotype was defined as any of the pneumococcal S. pn. vaccine serotypes, e. a. serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400086|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400087|NCT01262872|Secondary|Number of Subjects With Streptococcus Pneumoniae (Any) in the Nasopharynx – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Numbers of subjects with positive nasopharyngeal sample were calculated per group, at each swab time point. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400088|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400089|NCT01262872|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|From Day 0 to Month 10|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400345|NCT01260896|Primary|Cmax of Venlafaxine.|Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1400090|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400091|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with the first 2 doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400092|NCT01262872|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 31-day (Days 0-30) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400093|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400094|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 2+1 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400095|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination – For Step 2/Cohort 2 Subjects Receiving the 3+0 Schedule|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. This outcome concerns Step 2/Cohort 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400710|NCT01258049|Secondary|Parasite Clearance Time (PCT) [MITT Population]|Parasite clearance time (PCT). Time in hours from the initiation of therapy until the first of two successive parasite negative smears (zero parasite counts) are obtained|28 days after start of treatment||||hours||Standard Deviation|Mean
1400096|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) period post vaccination with Dose 3 of pneumococcal vaccine (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400097|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 2+1 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 2+1 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with the 2 first doses of pneumococcal vaccine (10PP vaccine or Synflorix™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400098|NCT01262872|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – For Cohort2/Step 2 Subjects Receiving the 3+0 Schedule.|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). This outcome concerns Cohort2/Step 2 subjects receiving the 3+0 Schedule.|Within the 4-day (Days 0-3) periods post vaccination with 3 doses of pneumococcal vaccine (10PP vaccine, Synflorix™ or Prevnar 13™), across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400099|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400100|NCT01262872|Secondary|Titers of Antibodies Against Yellow Fever (Anti-YF) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-yellow fever antibody titers ≥ 10.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400101|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1400102|NCT01262872|Secondary|Concentrations of Antibodies Against Measles (Anti-Measles) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Measles antibody concentrations ≥ 150 mIU/mL.|At 3 months (Mth) post-vaccination with Stamaril™/M-Vac™|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1400103|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400104|NCT01262872|Secondary|Antibody Titers Against Poliovirus 1, 2 and 3 (Anti-Polio, Anti-Polio 2 and Anti-Polio 3) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-Polio titers ≥ 8.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400105|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1400106|NCT01262872|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigens (Anti-HBs) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-HB antibody concentrations ≥ 10 mIU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1400107|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400108|NCT01262872|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400109|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1400110|NCT01262872|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (Anti-BPT) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seropositivity rate = Anti-BPT concentrations ≥ 15 EL.U/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1400111|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 2 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1400112|NCT01262872|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule. Seroprotection rate = Anti-D or anti-T antibody concentrations ≥ 0.1 IU/mL.|At 1 month post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1400113|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400114|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The results of analysis of the anti-Ply haemolysis activity inhibition for Cohort 2 are not presented as assay was no longer available. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400115|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|No analysis was performed on opsonophagocytic activity for Antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400116|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400117|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||2017-12-31|12/2017||||
1400118|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 19A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||2017-12-31|12/2017||||
1400119|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400120|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3 and 6A – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400121|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400122|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 2/Step 2 receiving the 3+0 Schedule.|At 1, 5 and 8 months post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400123|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400124|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. This outcome concerns subjects enrolled in Cohort 2/Step 2.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400125|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)||2017-12-31|12/2017||||
1400346|NCT01260883|Secondary|Oximetry Saturation Under 90% After Ketorolac or Placebo Infusion in 6-18 Month Old Infants|continuous oximetry monitoring for 12 hours after ketorolac or placebo intravenous infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo|||per cent time of 12 hours||Standard Deviation|Mean
1400126|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)||2017-12-31|12/2017||||
1400127|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400128|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3 and 19A – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400129|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 2+1 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400130|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 2/Step 2 Subjects Who Received the 3+0 Schedule|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400131|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1400132|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|Anti-PD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay, expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1400133|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 2+1 Schedule|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).~Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 2+1 Schedule."|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1400134|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 2/Step 2 Subjects Receiving the 3+0 Schedule|"Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).~Cut-off of the assay were concentrations higher than or equal to (≥) 12 EL.U/mL for anti-Ply antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 2/Step 2 who received the 3+0 Schedule."|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1400135|NCT01262872|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies – For Cohort 1/Step 1 Subjects|Concentrations of Hem-Ply antibodies were expressed as geometric mean titers . The cut-off of the assay was an Hem-Ply antibody titer ≥ 140. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400136|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400137|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400138|NCT01262872|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects|The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1400139|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotype 6C – For Cohort 1/Step 1 Subjects|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay were available. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.||||||
1400140|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 3, 6A and 19A – For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400141|NCT01262872|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F – For Cohort 1/Step 1 Subjects|Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1400142|NCT01262872|Secondary|Antibody Concentrations Against Protein D (PD) – For Cohort 1/Step 1 Subjects|Anti-PD antibody concentrations were measured by Multiplex immunoassay, expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 112 LU/mL. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||LU/mL||95% Confidence Interval|Geometric Mean
1400729|NCT01257750|Primary|Central Corneal Thickness|Pachymetry was used to measure the central corneal thickness of each study subject. Central corneal thickness was measured throughout the study to assess subjects for ocular adverse events.|12 Weeks|All enrolled patients were analyzed.|||Microns||Standard Deviation|Mean
1400143|NCT01262872|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – For Cohort 1/Step 1 Subjects|"Anti-Ply and anti-PhtD antibody concentrations were measured by Multiplex immunoassay and expressed as geometric mean concentrations (GMCs), in Luminex Units per milliliter (LU/mL).~Cut-off of the assay were concentrations higher than or equal to (≥) 599 LU/mL for anti-Ply antibodies and ≥ 391 LU/mL for anti-PhtD antibodies. This outcome concerns subjects enrolled in Cohort 1/Step 1."|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||LU/mL||95% Confidence Interval|Geometric Mean
1400144|NCT01262872|Secondary|Number of Subjects With Serious Adverse Events (SAEs) – For Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400145|NCT01262872|Secondary|Number of Subjects With Haematological or Biochemical Abnormalities With Respect to Normal Laboratory Ranges – For Cohort 1/Step 1 Subjects|Assessed biochemical and haematological parameters were: Haemoglobin (Hgb), White cell count (WBC), Platelet counts, Alanine aminotransferase (ALT) and Creatinine (CREA). Per parameter, it was assessed whether subjects had laboratory values below normal, normal, or above normal range. Below = value below the laboratory reference range defined for the specified time point and laboratory parameter. Within = value within the laboratory reference range defined for the specified time point and laboratory parameter. Above = value above the laboratory reference range defined for the specified time point and laboratory parameter. Unknown = value unknown for the specified time point and laboratory parameter. This outcome concerns subjects enrolled in Cohort 1/Step 1.|At Month 1, or 1 month post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400146|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 2+1 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of isolates.|At 1 and 5 months (Mth) post-Dose 2, and at 3 months post-Dose 3 of the pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400147|NCT01262872|Primary|Number of Subjects With Non-vaccine Serotypes of Streptococcus Pneumoniae (S. pn.) in the Nasopharynx – For Cohort 2/Step 2, Subjects Receiving the 3+0 Schedule|Any serotype belonging to the same serogroup as the serotypes of the pneumococcal vaccine administered (10PP vaccine or Synflorix™), but different from 10 vaccine pneumococcal serotypes, was considered for this analysis of carriage. Serotypes were identified through cultures and serotyping of the isolates.|At 1, 5 and 8 months (Mth) post-Dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400148|NCT01262872|Primary|Number of Subjects With Any Serious Adverse Events (SAEs) and With SAE(s) With Relationship to Vaccination - In Step 1/Cohort 1 Subjects|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity. These should also be considered serious: invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation. Any = Occurrence of an SAE, regardless of relationship to vaccination. Related = Occurrence of an SAE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of SAE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|From Day 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400149|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs) With and Without Relationship to Vaccination - In Step 1/Cohort 1 Subjects|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any = Occurrence of AE, regardless of intensity or relationship to vaccination. Grade 3 = Occurrence of AE which prevented normal activities. Related = Occurrence of AE assessed by the investigator as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 unsolicited AE(s) assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 31-day (Days 0-30) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400236|NCT01262287|Secondary|Change in Standard Drinks Per Week - Moderation by Genetic Variation|Moderation of primary outcome measure [change in standard drinks per week from baseline to end point (average weeks 7 and 8 of treatment)] by genetic variation rs12529 in neuroactive steroid biosynthetic enzyme gene AKR1C (AKR1C3*2 C-allele associated with alcohol use disorder)|Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)||||standard drinks per week||Standard Error|Mean
1400150|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms With and Without Relationship to Vaccination – For Step 1/Cohort 1 Subjects|Assessed solicited general symptoms were Drowsiness, Fever (axillary temperature higher than [≥] 37.5 degrees Celsius [°C]), Irritability/Fussiness and Loss of appetite. Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Fever = Axillary temperature higher than (>) 39.5°C. Grade 3 Irritability/fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Primary results correspond to results for occurrences of Grade 3 symptoms assessed as related to vaccination. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400151|NCT01262872|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms and Grade 3 Solicited Local Symptoms With Relationship to Vaccination – For Step 1/Cohort 1 Subjects|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). All solicited local symptoms were systematically considered by the investigators as causally related to vaccination. Primary results correspond to results for occurrences of Grade 3 symptoms. This outcome concerns subjects enrolled in Cohort 1/Step 1.|Within the 4-day (Days 0-3) period post vaccination with pneumococcal vaccine (10PP vaccine or Prevnar 13™)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1400152|NCT01262846|Primary|Immunogenicity|To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.|Baseline to 21 days|All participants except 5 participants with missing data at day 21|||Geometric Mean antibody titer||95% Confidence Interval|Geometric Mean
1400153|NCT01262820|Secondary|Overall Survival|Overall survival is defined as the time of enrollment until death|Eight (8) months w additional time for response date to mature (up to 2 years per participant)||||weeks||95% Confidence Interval|Median
1400154|NCT01262820|Secondary|Progression Free Survival|Progression free survival is defined as time of enrollment until disease progression or death Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Progression is defined as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Target lesions are representative of all involved organs and measurable by radiographic imaging.|Eight (8) months w additional time for response data to mature (up to 2 years per participant)||||weeks||95% Confidence Interval|Median
1400155|NCT01262820|Secondary|Combined Response Rate (CR + PR) of Pazopanib According to RECIST v1.1|Estimate of combined response rate (Complete Response (CR) + Partial Response (PR) per RECIST v1.1 Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions.Target lesions are representative of all involved organs and measurable by radiographic imaging.|8 months with additional time for response to mature (up to 2 years per participant)||||participants|||Number
1400156|NCT01262820|Primary|Disease Control Rate|Response (CR + PR + SD) as defined by RECIST v1.1 lasting equal to or greater than 12 weeks in patients treated with pazopanib alone for stage IIIB/IV non-squamous NSCLC after progression on first line therapy containing bevacizumab Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR) is defined as Disappearance of all target lesions; Partial Response (PR), as a >=30% decrease in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions; Progression, as a 20% increase in the sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) of all target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Target lesions are representative of all involved organs and measurable by radiographic imaging.|Eight (8) months w additional time for response date to mature (up to 2 years per participant)||||% of participants with disease control||95% Confidence Interval|Number
1400157|NCT01262755|Primary|Epidemiologic Factors Associated With Prevalent Reflux Disease.|Patients will complete a series of standardized questionnaires to determine the prevalence of reflux disease and risk factors for its development. We will query diet, depression, drug, tobacco, and alcohol use as well as a variety of other factors. We will study 450 African Americans living in North Philadelphia.|Two years|Patients successfully identified from targeted area.|||percentage of participants with GERD||95% Confidence Interval|Number
1400158|NCT01262677|Secondary|Percentage of Participants With Laboratory Test Abnormalities During the Study|Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
1400159|NCT01262677|Secondary|Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase|The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR.|Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
1400160|NCT01262677|Secondary|Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms|The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated.|Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
1400161|NCT01262677|Secondary|Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase|Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema).|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
1400162|NCT01262677|Secondary|Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)|C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events.|Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
1400163|NCT01262677|Secondary|Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase|Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait.|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
1400164|NCT01262677|Secondary|Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase|Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.|Day 1 to Week 15|The safety population included all randomized participants who took at least one dose of the study medication. The safety population consisted of: Pregabalin 165 mg: 100, Pregabalin 330 mg: 113, Placebo: 110.|||percentage of participants|||Number
1400165|NCT01262677|Secondary|BSW: Willingness to Continue Question|The BSW consisted of 3 single-item measures designed to capture the participant`s perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
1400166|NCT01262677|Secondary|BSW: Satisfaction From Treatment Question|The BSW consisted of 3 single-item measures designed to capture the participant’s perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
1400167|NCT01262677|Secondary|Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question|The BSW consisted of 3 single-item measures designed to capture the participant’s perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
1400168|NCT01262677|Secondary|Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale|Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal.|Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
1400169|NCT01262677|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400170|NCT01262677|Secondary|Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400171|NCT01262677|Secondary|Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400172|NCT01262677|Secondary|Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400173|NCT01262677|Secondary|Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||hours||Standard Deviation|Mean
1400174|NCT01262677|Secondary|Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400175|NCT01262677|Secondary|Change From Baseline in MOS-SS - Snoring Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400730|NCT01257750|Primary|Mean Arterial Pressure|Mean arterial pressure was measured throughout the study to assess subjects for systemic adverse events..|12 Weeks||||mmHG||Standard Deviation|Mean
1400176|NCT01262677|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14|Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400177|NCT01262677|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400178|NCT01262677|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline, Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||units on a scale||Standard Deviation|Mean
1400179|NCT01262677|Secondary|Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 2 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln(28-day seizure rate)||Standard Error|Least Squares Mean
1400180|NCT01262677|Secondary|Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
1400181|NCT01262677|Secondary|Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 2 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln (seizures per 28 days)||Standard Error|Least Squares Mean
1400182|NCT01262677|Secondary|Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||seizures per 28 days||Standard Deviation|Mean
1400183|NCT01262677|Secondary|Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln (seizures per 28 days)||Standard Error|Least Squares Mean
1400184|NCT01262677|Secondary|Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder.|Week 0 to Week 14|The ITT population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||percentage of participants|||Number
1400185|NCT01262677|Primary|Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase|Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.|Week 0 to Week 14|The intent-to treat (ITT) population consisted of all randomized participants who received at least one dose of double-blind treatment, and had a baseline and at least one follow-up double-blind treatment phase assessment visit. The ITT population was the primary sample and included: Pregabalin 165 mg: 100, Pregabalin 330 mg: 112, Placebo: 109.|||ln (seizures per 28 days)||Standard Deviation|Mean
1400186|NCT01262651|Secondary|Change From Baseline In NRS Constipation At Last Visit (Up To Day 36)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was “no constipation”, and 10 was “constipation as bad as you can imagine.” Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.~A negative value indicates improvement in condition from Baseline."|Baseline, Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1400187|NCT01262651|Secondary|Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment|"Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalents dose usages for each break-through opioid was calculated for the summary.~Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Baseline daily break-through opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1400188|NCT01262651|Secondary|Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of Treatment|"The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: “Have you used your maintenance dose painkiller today as prescribed?” If the participant answered “No” to the question, the daily opioid maintenance dose usage on that day was set to 0.~Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Baseline daily maintenance opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1400189|NCT01262651|Secondary|Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment|"The total daily opioid use (in morphine equivalence) was the sum of morphine equivalents of daily maintenance dose and break-through dose.~Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Baseline daily total opioid use.~A negative value indicates a decrease in use from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
1400190|NCT01262651|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 36)|The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers “Extremely satisfied, Very satisfied, Slightly satisfied, Neutral, Slightly dissatisfied, Very dissatisfied, Extremely dissatisfied”. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1400191|NCT01262651|Secondary|Physician Global Impression Of Change At Last Visit (Up To Day 36)|The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: “Very much worse, Much worse, Slightly worse, No change, Slightly improved, Much improved, Very much improved”. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1400237|NCT01262287|Primary|Change Number of Standard Drinks Per Week.|Change in Average Standard Drinks (14 gr ethanol) per week: last 2 weeks of treatment (wk 7-8) minus baseline average drinking average from baseline 90 day drinking history|Baseline (average weekly drinking for 90 day period prior to screening) vs. End Point (average weekly drinking weeks 7 and 8 of treatment)||||standard drinks per week||Standard Error|Mean
1400192|NCT01262651|Secondary|Subject Global Impression Of Change At Last Visit (Up To Day 36)|The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse”. The SGIC was assessed at Day 36 or at which a participant’s last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
1400193|NCT01262651|Secondary|Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment|"Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated “did not disrupt sleep” and a score of 10 indicated “completely disrupted (unable to sleep at all).” Change in mean sleep disruption NRS was calculated as: End of Treatment sleep disruption NRS score - Baseline sleep disruption NRS score.~A negative value indicates an improvement in sleep disruption score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1400194|NCT01262651|Secondary|Change From Baseline In Mean NRS Worst Pain At End Of Treatment|"Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated “no pain” and a score of 10 indicated “pain as bad as you can imagine.” Change in mean NRS worst pain was calculated as: End of Treatment NRS worst pain score - Baseline NRS worst pain score.~A negative value indicates an improvement in worst pain score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1400195|NCT01262651|Secondary|Change From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated “no pain” and a score of 10 indicated “pain as bad as you can imagine.” Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Baseline NRS average pain score.~A negative value indicates an improvement in average pain score from Baseline."|Baseline, End Of Treatment (Day 36)|ITT Population included all participants who receive at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
1400196|NCT01262651|Primary|Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was “no pain” and 10 was “pain as bad as you can imagine”. Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated).~Percentage improvement from baseline (Imp%) was calculated as:~Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean * 100.~For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew unrelated to disease progression before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||percent improvement||Inter-Quartile Range|Median
1400197|NCT01262599|Secondary|Levels of Cytokines|Concentration of the cytokines IL1-beta in the wound bed. Exudates will be collected from standard Jackson-Pratt #10 drains until the patient is discharged. IL1-beta is an early central proinflammatory cytokine that induces cyclooxygenase, an enzyme responsible for prostaglandin synthesis. A decrease in IL1-beta correlates with a decrease in pain. Cytokines and growth factors may contribute to more rapid post-op pain reduction and healing.|4 days|||||||
1400198|NCT01262599|Secondary|Amount of Narcotic Pain Medications|We will record the amount of pain medication used at twelve hour intervals for the duration of the hospital stay. Pain medications will be converted to oxycodone/acetaminophen equivalents for statistical analysis|4 days|||||||
1400199|NCT01262599|Primary|Pain Score Measured by Visual Analog Scale|We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.|12 hours||||units on a scale||Standard Deviation|Mean
1400200|NCT01262573|Secondary|Dyspareunia|Assessed preoperatively and up to 3 months postop|Postoperative||||participants|||Number
1400201|NCT01262573|Primary|Vaginal Cuff Closure Time|Average time (measured in minutes)|During the surgical procedure||||minutes||Standard Deviation|Mean
1400214|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) during open-label treatment period|||participants|||Number
1400238|NCT01262131|Primary|Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.|"Minimum scale value is '0' which represents 'no pain at all' and is the best outcome.~Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome."|2 weeks (baseline to end of treatment)|Analysis was by intention to treat which included all enrolled subjects in this case to study completion.|||Scores on a scale||Standard Deviation|Mean
1400202|NCT01262560|Secondary|Patient Reported Difficulty in Swallowing Associated With Manuka Honey Using the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)|Change from baseline to four weeks in patient-reported difficulty in swallowing via the PRO-CTCAE. PRO-CTCAE is an item bank consisting of individual items to assess adverse symptom events from the patient perspective. There are 78 symptoms included in the survey but the primary item of interest assesses difficulty swallowing. For each AE in the PRO-CTCAE, between 1 and 3 items are included to assess the frequency, severity, and/or interference with activities related to that AE. Frequency questions have responses ranging from never, which is scored as a 0, to almost constantly, which is scored as a 4. Severity questions have responses ranging from none, which is scored as a 0, to very severe, which is scored as a 4. Interference questions have responses ranging from not at all, which is scored as a 0, to very much, which is scored as a 4. Difficulty in swallowing only has a severity question.|Baseline and 4 weeks from the start of treatment|Randomized eligible patients who started treatment with measure at both baseline and 4 weeks.|||units on a scale||Inter-Quartile Range|Median
1400203|NCT01262560|Secondary|Adverse Events Associated With Manuka Honey Using CTCAE v4.0|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Until 12 weeks from the start of treatment|Randomized eligible patients who started protocol treatment.|||percentage of patients|||Number
1400204|NCT01262560|Secondary|Percentage of Patients Using Opioids|The percentage of patients using opioid analgesics is reported. Use of opioid analgesics was assessed for a 24-hour period before completing the assessment. Patients with at least one reported administration of opioid analgesic were considered to have received opioid analgesics.|Baseline, 4 weeks, end of radiation treatment, and 12 weeks from the start of treatment|Randomized eligible patients with opioid use information at at least one time point.|||percentage of participants|||Number
1400205|NCT01262560|Secondary|Nutritional Status (Change in Serum Prealbumin Levels From Baseline to 4 Weeks)||Baseline and 4 weeks from the start of treatment|Randomized eligible patients with serum prealbumin at baseline and 4 weeks.|||mg/dl||95% Confidence Interval|Mean
1400206|NCT01262560|Secondary|Percent Change in Weight From Baseline to 4 Weeks||Baseline and 4 weeks from the start of treatment|Randomized eligible patients with weight at both baseline and 4 weeks.|||percentage of baseline value||95% Confidence Interval|Mean
1400207|NCT01262560|Secondary|Percentage of Participants With Radiation Esophagitis Grade 3-4 (CTCAE v. 4)|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For esophagitis specifically, Grade 3 criteria includes severely altered eating/swallowing, tube feeding, total parenteral nutrition (TPN) or hospitalization indicated. Grade 4 criteria include life-threatening consequences, urgent operative intervention indicated.|Up to 12 weeks from the start of treatment|Randomized eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
1400208|NCT01262560|Secondary|Quality of Life and Pain, as Measured by the EORTC QLQ-30 Global QOL Score and Pain Symptom Subscale at 4 and 12 Weeks|The pain symptom subscale (2 items) evaluated pain and the global score (30 items) evaluated quality of life. Each ranges from 0-100 with lower scores indicating lesser burden and improved symptoms or quality of life.|Baseline, 4 and 12 weeks from the start of treatment|Randomized eligible patients who received protocol treatment with at least 1 EORTC score completed across all time points.|||units on a scale||Inter-Quartile Range|Median
1400209|NCT01262560|Secondary|Dysphagia Via Daily Patient Log|"Dysphagia, as reported by the patient, was measured by the patient swallowing diary. Swallowing score has increasing severity 1-5, where 1 = none and 5 = cannot swallow liquids."|Weekly during treatment and 12 weeks from the start of treatment|Randomized eligible patients who received protocol treatment with at least one dysphagia score completed across all time points.|||units on a scale||Inter-Quartile Range|Median
1400210|NCT01262560|Secondary|Radiation Esophagitis-related Pain During Treatment as Measured During Treatment and 12 Weeks by the Numerical Rating Pain Scale (NRPS)|Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from values at the later time points. The experimental arms (honey) were compared to the standard arm (supportive care).|Baseline, weekly during treatment, and 12 weeks from the start of treatment|Eligible patients who started protocol treatment with at least 1 NRPS score completed across all time points|||units on a scale||Inter-Quartile Range|Median
1400211|NCT01262560|Primary|Change in Radiation Esophagitis-related Pain at 4 Weeks as Measured by the Numerical Rating Pain Scale for Pain on Swallowing (NRPS)|Esophagitis-related pain was measured using patient-reported pain on swallowing as assessed by the Numerical Rating Pain Scale (NRPS), an 11-point scale (0-10) in which 0 indicates no pain and 10 indicates the worst pain imaginable. Generally, scores of 1-4 indicate mild pain, scores of 5-6 indicate moderate pain, and scores of 7-10 indicate severe pain. Change was calculated by subtracting the baseline value from the 4-week value. The experimental arms (honey) were compared to the standard arm (supportive care).|Baseline and 4 weeks from the start of treatment|Randomized eligible patients with NRPS score at both baseline and 4 weeks.|||units on a scale||Inter-Quartile Range|Median
1400212|NCT01262547|Secondary|Incidence of Adverse Effects, Including Increased Activity of Vitiligo||24 weeks||||participants reporting redness|||Number
1400213|NCT01262547|Primary|Change in Target VASI Score From Baseline to Week 24.|Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).|24 weeks||||units on a scale||Full Range|Mean
1400233|NCT01262352|Secondary|Absolute Change From Baseline in Percent Predicted FEV1|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||percent||Standard Error|Least Squares Mean
1400215|NCT01262456|Secondary|Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period|Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)|||participants|||Number
1400216|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|Month 1 of open-label period (Month 4 of treatment)|Safety analysis set (SAS) for open label-treatment period|||participants|||Number
1400217|NCT01262456|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period|A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.|From Day 1 through Month 3 (double-blind period)|Safety analysis set (SAS)|||participants|||Number
1400218|NCT01262456|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
1400219|NCT01262456|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
1400220|NCT01262456|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||minutes||Standard Deviation|Mean
1400221|NCT01262456|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|FAS, including participants with complete data supporting this outcome in the participant diary.|||probability|||Number
1400222|NCT01262456|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||nocturnal voids||Standard Deviation|Mean
1400223|NCT01262456|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).|||probability|||Number
1400234|NCT01262352|Primary|Absolute Change From Baseline in Lung Clearance Index (LCI)|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal SF6 concentration to 1/40th of the starting value.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||ratio||Standard Error|Least Squares Mean
1400224|NCT01262456|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level."|Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)|Full analysis set (FAS).|||nocturnal voids||Standard Deviation|Mean
1400225|NCT01262365|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 48|Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
1400226|NCT01262365|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 24|Subjects with a missing corticosteroid dose at any visit for any reason are counted in the Dose Increased or Missing Data category for that visit.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
1400227|NCT01262365|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 36|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
1400228|NCT01262365|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 12|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
1400229|NCT01262365|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
1400230|NCT01262365|Primary|The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set. The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of study drug, with the exception of 45 subjects who were randomized at Site 071, located in the USA, who were excluded from the FAS.|||percentage of participants|||Number
1400231|NCT01262352|Secondary|Change From Baseline in CF Questionnaire-Revised (CFQ-R) Score (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID). The primary analytical focus was the respiratory health domain, which was analyzed by combining all self-response questionnaire versions from different age groups (e.g., Adult/Adolescent and Child versions).|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||score on a scale||Standard Error|Least Squares Mean
1400232|NCT01262352|Secondary|Change From Baseline in Sweat Chloride|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Baseline through Day 29|All randomized subjects who received at least 1 dose of study drug (placebo or ivacaftor) and had available assessments during the time frame.|||millimoles per liter||Standard Error|Least Squares Mean
1400239|NCT01262118|Secondary|Cholesterol Efflux Rate|Cholesterol efflux rate was measured using isotope dilution method in which rate of appearance of isotope 13C-free cholesterol in plasma representing whole body efflux from tissues was assessed. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg/kg)/hr||Standard Deviation|Mean
1400240|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate|Fractional catabolic rate for HDL-apoA1 were calculated using the 13C isotopic enrichment of VLDL as the limiting value. Isotope 13C in plasma was measured using GC-C-IRMS.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||%/hr||Standard Deviation|Mean
1400241|NCT01262118|Secondary|High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate|HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/kg/hr||Standard Deviation|Mean
1400242|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate|Fractional catabolic rate for LDL ApoB were calculated using the 13 carbon (13C) isotopic enrichment of very low density lipoprotein (VLDL) as the limiting value. Isotope 13C in plasma was measured using Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS).|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||%/hr||Standard Deviation|Mean
1400243|NCT01262118|Secondary|Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate|LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg/kg)/hr||Standard Deviation|Mean
1400244|NCT01262118|Secondary|Cholesterol Ester Fractional Catabolic Rate|Cholesterol ester fractional catabolic rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. Fractional catabolic rate was the percentage of cholesterol ester which was replaced, transferred or lost per unit of time.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage ester per hour (%/hr)||Standard Deviation|Mean
1400245|NCT01262118|Secondary|Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration|Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.|Baseline, Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.|||mg/dL||Standard Deviation|Mean
1400246|NCT01262118|Primary|Cholesterol Ester Production Rate at Week 6|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg/kg)/hr||Standard Deviation|Mean
1400247|NCT01262118|Primary|Cholesterol Ester Production Rate at Baseline|Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.|Baseline|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||(mg per kilogram) per hour ([mg/kg]/hr)||Standard Deviation|Mean
1400248|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6|Blood level of HDL-C was measured following a 12-hours fasting.|Week 6|FAS included all enrolled participants who had any measurement of cholesterol ester production rate available.|||mg/dL||Standard Deviation|Mean
1400249|NCT01262118|Primary|High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline|Blood level of HDL-C was measured following a 12-hours fasting.|Baseline|Full analysis set (FAS) included all enrolled participants who had any measurement of cholesterol ester production rate available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1400250|NCT01262105|Primary|Surgery Site CFU Density|CFU culture counts for samples taken in surgery.|Ten-minute intervals throughout procedure||||CFU/m3||95% Confidence Interval|Mean
1400251|NCT01262092|Primary|Illicit Opioid Use as Determine by Urine Dipsticks|urine data are from those obtained during the buprenorphine taper|3x weekly during wks 3 and 4|Those who started the bup detox (N=24) excluding 1 subjects' data in the gabapentin group due to evidence of noncompliance with medication procedures and diversion (N=1).|||% of urines positive for opioids|Participants|Standard Error|Mean
1400252|NCT01262027|Secondary|Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)|Safety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section.|6 months|Evaluation included all participants.|||percentage of participants|||Number
1400266|NCT01261793|Primary|The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
1400253|NCT01262027|Primary|Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants|Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram & ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response [MR]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. <50%. SD: Between MR & PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid|6 months|Three participants were not evaluable for response due to early departure from study.|||participants|||Number
1400254|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism presented in dioptres at each visit.|Visits 4-8|Surgically Induced Astigmatism—FAS Population|||Dioptres|Participants|Standard Deviation|Mean
1400255|NCT01261975|Secondary|Surgically Induced Astigmatism (SIA)|Surgically induced astigmatism was presented in dioptres at each visit.|Visits 1-3|Surgically Induced Astigmatism, FAS Population|||Dioptres|Participants|Standard Deviation|Mean
1400256|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|visit 5, visit 6, visit 7, visit 8|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
1400257|NCT01261975|Secondary|Uncorrected Visual Acuity|Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.|Visit 1, visit 2, visit 3, visit 4|Uncorrected Visual Acuity (logMAR), change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
1400258|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.|visit 5, visit 6, visit 7, visit 8|Best Corrected Distance Visual Acuity (logMAR), change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
1400259|NCT01261975|Secondary|Best Corrected Visual Acuity|Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity|Visit 1, visit 2, visit 3, visit 4|Best Corrected Distance Visual Acuity (logMAR), Change from baseline, FAS Population|||logMAR|Participants|Standard Deviation|Mean
1400260|NCT01261975|Primary|Refractive Stability|Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.|12 weeks|Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)— Full analysis Set (FAS) Population|||Eyes|Participants||Number
1400261|NCT01261793|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 48|Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.|At Week 48|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of participants|||Number
1400262|NCT01261793|Secondary|Change From Baseline in Daily Corticosteroid Dose at Week 24|Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of subjects|||Number
1400263|NCT01261793|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 36|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
1400264|NCT01261793|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 12|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
1400265|NCT01261793|Secondary|The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index|Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician’s global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.|At Week 24|The Full Analysis Set (FAS) consisted of all subjects in the Randomized Set (RS) who had received at least 1 partial dose of the study drug.|||Percentage of responders|||Number
1400267|NCT01261780|Secondary|Adverse Events|The number of participants experiencing adverse events, as defined by CTCAE|Up to 3 months||||participants|||Number
1400731|NCT01257750|Primary|Heart Rate|Heart rate through was measured throughout the study to assess subjects for systemic adverse events.|12 Weeks|All enrolled patients were analyzed.|||Beats per Minutes||Standard Deviation|Mean
1400268|NCT01261780|Primary|Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)|"Pain levels will be compared as measured by changes in mVAS, and quantified and tested for normal distribution. If normally distributed, parametric test (i.e., two-sample t-test) will be used; p-values <0.05 will be considered statistically significant. If changes in mVAS are not normally distributed, non-parametric testing such as Wilcoxon rank-sum will be performed. VAS is measured at 3 time points.~mVAS and deficits scale are used to obtain continuous quantitative information about positive and negative sensory phenomena during application of QSPT stimulation.~Patients provide rating of positive sensory phenomena using mVAS if the stimulus at the pain test site is increased or painful when compared to normal control site. Rating on mVAS is obtained by instructing the patient to pull out the mechanical scale with millimeters (looks like a slide ruler) to reflect intensity of any painful sensation on a scale of 0 - 10, with 10 being the worst. Score = Visit - Baseline."|Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks)|The number analyzed differs per row as some participants dropped out or did not receive all 10 treatments. For example, on the Sham Device arm, only 4 participants were treated on day 10 but 5 returned for the final visit. Because this was a pilot study, all participant data was analyzed and is included here.|||Millimeters||Standard Deviation|Mean
1400269|NCT01261624|Secondary|ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12|ACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0- 100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 50, 70, 90 and 100 of response, defined as a 50%, 70%, 90% and 100% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|at week12||||participants|||Number
1400270|NCT01261624|Primary|ACR Pediatric Response Level (ACRPRL) 30 After 12 Weeks of Treatment|ACR Pediatric variables include: Physician’s Global Assessment of disease activity on a 0-100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent’s or patient’s Global Assessment of Patient’s overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 30 of response, defined as a 30% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by > than 30%|12 weeks of treatment||||participants|||Number
1400271|NCT01261559|Secondary|Number of Participants With Presence of Artifacts Based on CT Image Quality|"CT images acquired will be reviewed for the presence of artifacts that might be attributed to the displacement device or to the presence of the breast tissue.~To evaluate for artifacts, the exam will be qualitatively reviewed by a board certified radiologist for imaging artifacts, such as streak artifact. It will be noted on a per participant basis whether any imaging artifacts are identified."|two months||||Participants|||Count of Participants
1400272|NCT01261559|Secondary|CT Image Noise|"To evaluate image noise, mean of the Standard deviation (SD) of the pixel values, measured in Hounsfield units (HU), will be measured in Picture Archiving and Communication System (PACS) using a region of interest (ROI) measuring 90-110 mm^2 in size drawn over each of these body regions: hepatic dome, spleen, renal cortex, retroperitoneal fat, subcutaneous fat, paraspinal muscles, and if present, breast tissue, avoiding vascular structures in each case. SD for ROI measuring 90-110 mm^2 in size will also be drawn over the aorta and inferior vena cava (IVC), remote from contrast mixing artifact, and over medullary bone of the spine.~HU is the linear scale by which digital image data are displayed in PACS and reflect relative attenuation compared to distilled water at a standard temperature and pressure (STP) (defined as 0 HU) and of pure air at STP (defined as -1000HU). Within a drawn ROI, the PACS will give the mean attenuation (in HU) and the standard deviation of HU (reflecting"|two months|In some cases, a reliable measurement of noise could not be measured on the location. For example, if the breast was not included on the CT, breast noise could not be measured (12 controls and 21 Chrysalis). Too little retroperitoneal or subcutaneous fat was present to draw the relevant ROI in 1 control and 1 Chrysalis subject, respectively.|||Hounsfield units||Standard Deviation|Mean
1400273|NCT01261559|Primary|Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)|Relative skin entrance dose at the breast (group mean of patient's average skin entrance dose at TLDs 2-4) divided by skin entrance dose at the inframammary TLD (TLD 1) in %. For each patient, doses at TLDs 2-4 were averaged, and then the group mean of this was divided by the group mean at the inframammary TLD, then multiplied by 100 to get % dose. A relative dose of 20% means that the skin entrance dose at the breast was 20% of the skin entrance dose at the inframammary fold.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour||||percentage of dose||Standard Deviation|Mean
1400274|NCT01261559|Primary|Skin Entrance Radiation Dose During Computed Tomography (CT)|Skin entrance radiation doses will be measured with Thermoluminescent dosimeters (TLDs) affixed to the subject's chest and breast during CT of the abdomen. TLD #1 is at the inframammary fold, serving as internal control for each subject. Three additional TLDs (#2-4) are affixed to the subject's breast at 3 pre-ascribed locations. The same is done for the right and left breasts (8 TLDs total). TLDs will then be submitted to Landaeur for measurement.|from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour||||mrad||Standard Deviation|Mean
1400287|NCT01261390|Secondary|Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline|Baseline Peak Tricuspid Regurgitation Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
1400275|NCT01261507|Secondary|False Positive Decisions of Radiologists|This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level.|1 day||||percentage of marks not on cancers||Standard Error|Mean
1400276|NCT01261507|Secondary|Sensitivity and Specificity|Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected.|1 day||||Percentage of cases||Standard Error|Mean
1400277|NCT01261507|Primary|Localized Receiver Operating Characteristic (LROC) Comparison|"The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as noise cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement."|1 day|All participants were included for calculation of A-LROC and Sensitivity-Specificity. All radiographs were interpreted both without and with software assistance|||unitless|Participants|Standard Error|Mean
1400278|NCT01261390|Secondary|Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month|12 Month Peak Tricuspid Regurgitation Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
1400279|NCT01261390|Secondary|E/Em Lateral Ratio (4 Arm) - 12 Month|Endpoint E/Em Lateral Ratio measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mitral velocity ratio (absolute units)||Standard Deviation|Mean
1400280|NCT01261390|Secondary|Pulmonary Vascular Resistance (4 Arm) - 12 Month|Endpoint Pulmonary Vascular Resistance measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||Wood units||Standard Deviation|Mean
1400281|NCT01261390|Secondary|Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month|Endpoint Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
1400282|NCT01261390|Secondary|Right Ventricular Fractional Area Change (4 Arm) - 12 Month|Endpoint Right Ventricular Fractional Area Change measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage change in RV area||Standard Deviation|Mean
1400283|NCT01261390|Secondary|Ejection Fraction (4 Arm) - 12 Month|Endpoint Ejection Fraction measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage ejection fraction||Standard Deviation|Mean
1400284|NCT01261390|Secondary|End-Diastolic Volume (4 Arm) - 12 Month|Endpoint End-Diastolic Volume measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm||Standard Deviation|Mean
1400285|NCT01261390|Secondary|Left Atrial Volume Index (4 Arm) - 12 Month|Endpoint Left Atrial Volume Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||m/m2||Standard Deviation|Mean
1400286|NCT01261390|Secondary|Left Ventricular Mass Index (4 Arm) - 12 Month|Endpoint Left Ventricular Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||g/m2||Standard Deviation|Mean
1400341|NCT01260896|Secondary|AUC0-t of O-Desmethylvenlafaxine.|Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1400288|NCT01261390|Secondary|E/Em Lateral Ratio (4 Arm) - Baseline|Baseline E/Em Lateral Ratio measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mitral velocity ratio (absolute units)||Standard Deviation|Mean
1400289|NCT01261390|Secondary|Pulmonary Vascular Resistance (4 Arm) - Baseline|Baseline Pulmonary Vascular Resistance measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||Wood units||Standard Deviation|Mean
1400290|NCT01261390|Secondary|Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline|Baseline Tricuspid Annular Peak Systolic Myocardial Velocity measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm/sec||Standard Deviation|Mean
1400291|NCT01261390|Secondary|Right Ventricular Fractional Area Change (4 Arm) - Baseline|Baseline RV Fractional Area Change measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage change in RV area||Standard Deviation|Mean
1400292|NCT01261390|Secondary|Ejection Fraction (4 Arm) - Baseline|Baseline Ejection Fraction measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percent ejection fraction||Standard Deviation|Mean
1400293|NCT01261390|Secondary|End-Diastolic Volume (4 Arm) - Baseline|Baseline End-Diastolic Volume measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||cm||Standard Deviation|Mean
1400294|NCT01261390|Secondary|Left Atrial (LA) Volume Index (4 Arm) - Baseline|Baseline Left Atrial Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||m/m2||Standard Deviation|Mean
1400295|NCT01261390|Secondary|Left Ventricular (LV) Mass Index (4 Arm) - Baseline|Baseline Left Ventricular Mass Index measured via echocardiography.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Echocardiography measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||g/m2||Standard Deviation|Mean
1400296|NCT01261390|Secondary|Change in Augmentation Index at Months 6 and 12 (4 Arms)|Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percent of central pulse pressure||Standard Deviation|Mean
1400297|NCT01261390|Secondary|Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms)|Tonometry measurements of arterial stiffness were collected using a Sphygmacor. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Tonometry measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||m/s||Standard Deviation|Mean
1400298|NCT01261390|Secondary|Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm)|Plasminogen Activator Inhibitor-1 (PAI-1) was calculated from blood samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||AU/mL||Standard Deviation|Mean
1400299|NCT01261390|Secondary|Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm)|Urinary Albumin Creatinine Ratio was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||ug/mg||Standard Deviation|Mean
1400300|NCT01261390|Secondary|Change in Urine Microalbumin at Months 6 and 12 (4 Arm)|Urine Microalbumin was calculated from urine samples. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||ug/mL||Standard Deviation|Mean
1400301|NCT01261390|Secondary|Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm)|Glomerular Filtration Rate was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mL/min/1.73m^2||Standard Deviation|Mean
1400302|NCT01261390|Secondary|Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm)|Interleukin 6 (IL-6) was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||pg/dL||Standard Deviation|Mean
1400303|NCT01261390|Secondary|Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm)|Fasting Insulin was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||uIU/mL||Standard Deviation|Mean
1400304|NCT01261390|Secondary|Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm)|Hemoglobin A1c percentage was calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||percentage glycosylated hemoglobin||Standard Deviation|Mean
1400305|NCT01261390|Secondary|Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm)|Glucose, Fibrinogen, Creatinine and BNP measurements were calculated from blood and urine samples collected through fasting phlebotomy and urine collection. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mg/dL||Standard Deviation|Mean
1400306|NCT01261390|Secondary|Change in Lipid Panel at 6 and 12 Months (4 Arm)|Lipid panel measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Lipid measures were not able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mg/dL||Standard Deviation|Mean
1400307|NCT01261390|Secondary|Change in C-Reactive Protein at Months 6 and 12 (4 Arm)|C-Reactive Protein laboratory measurements were calculated from blood samples collected through fasting phlebotomy. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||mg/L||Standard Deviation|Mean
1400308|NCT01261390|Secondary|Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm)|The Calgary Sleep Apnea Quality of Life Index (SAQLI) is a scale intended to measure disease-specific quality of life. The SAQLI score ranges from 1 - 7, with higher scores indicating a higher quality of life. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
1400309|NCT01261390|Secondary|Change in Patient Health Questionnaire (PHQ8) (4 Arm)|The Patient Health Questionnaire (PHQ-8) is a scale intended to measure depression. The PHQ-8 score ranges from 0 24, with higher scores indicating increasing severity of depression. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
1400310|NCT01261390|Secondary|Change in Epworth Sleepiness Scale (ESS) (4 Arm)|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness. The ESS score ranges from 0 - 24, with higher scores indicating increasing possibility of specific sleep disorders. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
1400342|NCT01260896|Secondary|Cmax of O-Desmethylvenlafaxine.|Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1400311|NCT01261390|Secondary|Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm)|The 36-Item Short Form Survey (SF-36) is a patient-reported survey of patient health. The SF-36 scores range from 0-100, with lower scores indicating greater disability. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) with valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Not all measures were able to be collected from all participants. Not all participants completed 12 month visits (due to randomization date).|||units on a scale||Standard Deviation|Mean
1400312|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months.|6-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
1400313|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
1400314|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis.|6-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 6 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
1400315|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.|12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and 12 Month follow-up. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
1400316|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms)|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint. Number analyzed differs between rows due to individuals having insufficient readings during wake and/or sleep.|||mmHg||Standard Deviation|Mean
1400317|NCT01261390|Primary|Difference in CPAP Adherence by Active Treatment Arm|Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization.|6-months|Intent to treat population for those assigned to Active PAP (all individuals who were randomized to one of the two PAP arms).|||hours/night||Standard Deviation|Mean
1400318|NCT01261390|Primary|Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms|Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.|Mean of 6- and 12-months|Intent to treat population (all individuals who were randomized to a treatment arm) who had valid measurements of ambulatory blood pressure for baseline and at least one follow-up timepoint.|||mmHg||Standard Deviation|Mean
1400319|NCT01261325|Secondary|Time to the Tenth Type I Seizure During the Treatment Period||12 week Treatment Period||||days||95% Confidence Interval|Median
1400320|NCT01261325|Secondary|Time to the Fifth Type I Seizure During the Treatment Period||12 week Treatment Period||||days||95% Confidence Interval|Median
1400321|NCT01261325|Secondary|Time to the First Type I Seizure During the Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||days||95% Confidence Interval|Median
1400322|NCT01261325|Secondary|All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||number of seizures/ 28-day||Inter-Quartile Range|Median
1400323|NCT01261325|Secondary|Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period||12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||percentage of subjects|||Number
1400324|NCT01261325|Secondary|Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||percentage of subjects|||Number
1400325|NCT01261325|Secondary|Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period||Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||percentage of change||Inter-Quartile Range|Median
1400326|NCT01261325|Primary|50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration.|Baseline to 12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||Percentage of subjects|||Number
1400327|NCT01261325|Primary|Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration|Primary endpoint: United States of America (FDA)|12 week Treatment Period|Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary.|||Percentage of reduction|||Number
1400328|NCT01261247|Other Pre-specified|Pharmacokinetic/Pharmacodynamic of LBH589 and Correlation With Clinical Effects as Assessed by Immunoblotting, SNPs Analysis, Serum Cytokine Assays, and Flow Cytometry for Suppressive Monocytes (Correlative Studies)||At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years|||||||
1400329|NCT01261247|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient’s objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).|Every 6 months for up to 2 years|Patients who achieved a confirmed response were included in this analysis.|||months||95% Confidence Interval|Median
1400330|NCT01261247|Secondary|Median Progression-free Survival Time|The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) > 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, > 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.|Every 6 months for up to 2 years||||months||95% Confidence Interval|Median
1400331|NCT01261247|Secondary|Median Overall Survival Time|The median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Every 6 months for up to 2 years||||months||95% Confidence Interval|Median
1400332|NCT01261247|Primary|Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status|"The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with success for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients."|Every 28 days for up to 2 years|Patients who completed the study were evaluable for the primary outcome. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|||proportion of CR or PR patients||95% Confidence Interval|Number
1400333|NCT01261052|Secondary|Measurement of APD and FMPD/APD Interventions in Controlling Post-prandial Blood Glucose With Reduced Insulin Sensitivity.|Assessment of control of post prandial hyperglycemia with APD and FMPD/APD interventions using mean post-prandial glucose (3 hours after meals).|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment|||mg/dl||Standard Deviation|Mean
1400334|NCT01261052|Primary|Measurement of the Effectiveness of APD and FMPD/APD Intervention in Adapting to Reduced Insulin Sensitivity|The effectiveness of the APD and FMPD/APD intervention in adapting to reduced insulin sensitivity was analyzed using mean glucose.|all 33 hour studies|The number of participants for analysis was determined by an intention to treat (ITT) analysis based on the initial treatment assignment|||mg/dl||Standard Deviation|Mean
1400335|NCT01261000|Primary|Effect of Pegvisomant on Colon Tissue p53 Expression|Induction of colon tissue expression of p53, a tumor suppressor, using Western blot analysis, after GH receptor blockade with pegvisomant|8 weeks||||ng/mL||Standard Deviation|Mean
1400336|NCT01260948|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1400337|NCT01260948|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1400338|NCT01260922|Primary|AUC0-t of Donepezil.|Bioequivalence based on Donepezil AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1400339|NCT01260922|Primary|Cmax of Donepezil.|Bioequivalence based on Donepezil Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1400340|NCT01260896|Secondary|AUC0-inf of O-Desmethylvenlafaxine.|Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1400347|NCT01260883|Secondary|Total Morphine Use in 6-18 Month Old Infants After Ketorolac or Placebo Intravenous Infusion After Surgery|total amount of morphine given for 12 hours after ketorolac or placebo infusion in 6-18 month old infants after surgery|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac and 12 received placebo infusion after surgery|||mg/kg||Standard Deviation|Mean
1400348|NCT01260883|Primary|Half-life of Ketorolac Stereo-isomers in 6-18 Month Old Infants After Surgery|noncompartmental pharmacokinetic analysis of ketorolac stereo-isomers after intravenous infusion in postoperative infants|24 hours after surgery|52 infants of the 77 total were aged 6-18 months. 15 were excluded for abnormal laboratory values at screening or for lack of access to draw blood samples. 25 received drug, 12 placebo.Doses 0.5 or 1 mg/kg reported together since no difference in analysis.|||min||Standard Deviation|Mean
1400349|NCT01260883|Primary|Ketorolac Stereo-isomer Volume of Distribution Peripheral in 6-18 Month Old Infants|population-based analysis of ketorolac stereo-isomers|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded. 25 received ketorolac, 12 received placebo. Drug handling not different at doses of 0.5 or 1 mg/kg so reported together.|||ml||Standard Error|Mean
1400350|NCT01260883|Primary|Volume of Distribution for Ketorolac Isomers in 6-18 Month Old Infants|population-based kinetic analysis of ketorolac isomers following intravenous infusion in infants after surgery|24 hours after surgery|of 52 enrolled infants aged 6-18 months, 37 completed the study. Of these, 25 received drug, 12 placebo.Doses of 0.5 or 1 mg/kg showed no difference in handling so reported together.|||ml||Standard Error|Mean
1400351|NCT01260883|Primary|Clearance of S- and R+ Ketorolac in 6-18 Month Old Infants|stereo-specific ketorolac clearance by population-based analysis (NONMEM)|24 hours after surgery|52 infants aged 6-18 months enrolled; 15 excluded for abnormal laboratory results or intravenous sampling catheters that did not allow sampling. 25 infants aged 6-18 months received ketorolac, 12 received placebo. Doses of 0.5 or 1 mg/kg reported together since no difference found in handling.|||ml/min||Standard Error|Mean
1400352|NCT01260883|Secondary|Percent Time With Room Air Oximetry Saturations Under 90% in 2-6 Month Infants|continuous oximetry monitoring of room air saturation was collected for 12 hours after intravenous infusion of ketorolac or placebo|12 hours after ketorolac or placebo infusion|25 infants aged 2-6 months enrolled; 11 excluded. 8 received ketorolac, 6 placebo|||percentage of time in 12 h after drug||Full Range|Median
1400353|NCT01260883|Secondary|Morphine Use in 2-6 Month Old Infants Given Ketorolac or Placebo Following Surgery|total morphine given intravenously in the 12 hours following receiving intravenous ketorolac or placebo|first day after surgery|25 infants enrolled but 11 excluded. 8 received ketorolac, 6 placebo. total morphine given over 12 hours following infusion collected|||mg/kg||Standard Deviation|Mean
1400354|NCT01260883|Primary|Half-life of S- and R+ Ketorolac in 2-6 Month Old Infants|half-life calculated from non-compartmental analysis of ketorolac isomers in 2-6 month old infants given intravenous ketorolac following surgery|24 hours after surgery|total infants enrolled was 77; 26 were excluded before study procedures began. Of 51 infants completing the study, 8 infants aged 2-6 months received drug.No difference in analysis at doses of 0.5 or 1 mg/kg so reported together.|||min||Standard Error|Mean
1400355|NCT01260883|Primary|Peripheral Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|peripheral volume of distribution for ketorolac stereo-isomers determined by population kinetic analysis (NONMEM)|24 hours post surgery|25 infants aged 2-6 months enrolled; 11 excluded for no sampling intravenous access. 8 infants received drug, 6 received placebo. No difference in analysis of doses of 0.5 or 1 mg/kg so reported together.|||ml||Standard Deviation|Mean
1400356|NCT01260883|Primary|Central Volume of Distribution for S- and R+ Ketorolac in 2-6 Month Old Infants|stereo-specific ketorolac analysis using population-based analysis (NONMEM)for ketorolac given intravenously 24 hours after surgery in 2-6 month old infants|24 hours after surgery|infants enrolled but did not complete protocol if abnormal laboratory studies or intravenous catheters were not functioning prior to study drug infusion. Of 77 enrolled, 51 completed study; of the 33 given ketorolac,8 were aged 2-6 months. Doses of 0.5 or 1 mg/kg were handled similarly so reported together.|||ml||Standard Error|Mean
1400357|NCT01260883|Primary|Clearance of S-ketorolac and R+ Ketorolac in 2-6 Month Old Infants Following Surgery|stereo-isomer specific clearance determined by population-based pharmacokinetic analysis (NONMEM)|24 hours following surgery|of 25 infants aged 2-6 months enrolled, 11 were excluded. 8 received drug, 6 received placebo; this is a subset of the 77 enrolled infants (aged 2-18 months) of whom 51 completed the study. Infants receiving drug at 0.5 or 1 mg/kg were reported together, since no difference in drug handling was seen.|||ml/min||Standard Error|Mean
1400358|NCT01260701|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.|Up to 2 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
1400359|NCT01260701|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to < 1.0 cm. Partial response (PR) is >= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 2 years|Eligible patients who began protocol therapy and were assessed for response.|||percentage of participants||95% Confidence Interval|Number
1400360|NCT01260701|Primary|Overall Survival (OS)|Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who began protocol therapy.|||months||95% Confidence Interval|Median
1400361|NCT01260701|Secondary|Progression Free Survival (PFS)|PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Up to 2 years|Eligible patients who began protocol therapy|||months||95% Confidence Interval|Median
1400362|NCT01260688|Secondary|Quality of Life Assessment Using Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire|Scale is measured on a range from 0 (worst quality of life) to 156 (best quality of life).|Up to 16 weeks|Some participants (overall and post-baseline) did not complete the questionnaire or failed to answer more than 7 questions and could not be included in the analysis (a summary score could not be calculated).|||units on a scale||Full Range|Median
1400363|NCT01260688|Secondary|Overall Response Rate|Response Rate of Stable Disease and Progressive Disease|Duration of Study (median duration on study = 4 cycles)|Analysis of number of participants who experienced response rates of SD and PD.|||percentage of participants|||Number
1400364|NCT01260688|Secondary|Dose Reductions|The number of participants with dose reductions in each arm|Duration of Study (median duration on study = 4 cycles)|Analysis conducted on the number of participants with dose reductions in each arm of the study.|||Participants|||Count of Participants
1400365|NCT01260688|Secondary|Dose Interruption Due to AEs|The number of participants with dose-interruptions in each arm due to adverse events|Through study completion (median duration on study = 4 cycles)|Analysis was performed on study participants assessing the number of participants with dose-interruptions due to adverse events.|||Participants|||Count of Participants
1400366|NCT01260688|Secondary|Number of Participants With Increased Alkaline Phosphatase BAP|Number of participants with increased alkaline phosphatase BAP|Through study completion (median duration on study = 4 cycles)||||participants|||Number
1400367|NCT01260688|Secondary|Participants for Which Bone Biomarkers for Beta-C Telopeptide Was Reduced|Participants for which beta-C telopeptide was reduced|Through study completion (median duration on study = 4 cycles)|Analysis was done on study participatns for which beta-C telopeptide was reduced.|||Participants|||Count of Participants
1400368|NCT01260688|Secondary|Treatment Related Deaths|Number of treatment related deaths|Through study completion (median duration on study = 4 cycles)|In Arm II (Cediranib alone), 1 patient presented retroperitoneal hemorrhage (Grade 5).|||participants|||Number
1400369|NCT01260688|Secondary|Overall Response Rate|Best overall response rate of each evaluable patient|Duration of Study (median duration on study = 4 cycles)||||months||95% Confidence Interval|Median
1400370|NCT01260688|Secondary|Non-AE Related Treatment Discontinuation|Non-Adverse Event related Treatment Discontinuation|Through study completion (median duration on study = 4 cycles)||||participants|||Number
1400371|NCT01260688|Secondary|Treatment Discontinuation Due to Adverse Events (AEs)|Treatment discontinuation due to Adverse Events|Through study completion (median duration on study = 4 cycles)||||participants|||Number
1400372|NCT01260688|Secondary|Treatment Discontinuation|Discontinuation of treatment in cycle 1 (average of 28 days)|Cycle 1 (average of 28 days)|Analysis was performed on study participants enrolled on the trial assessing number of patients who discontinued treatment in cycle 1.|||Participants|||Count of Participants
1400373|NCT01260688|Secondary|Number Who Experienced Study Medication Dose Intensity|Number of patients who experienced study medication dose of over 80% during Cycle 1 was assessed.|Cycle 1 (an average of 28 days)||||participant|||Number
1400374|NCT01260688|Secondary|Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale|Present Pain Intensity (PPI) scale. Scale is measured 0-5, where 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain and 5=excruciating pain Participants who were up to completing the assessment (did not decline) and who reported a score >=2 at the end of any cycle are reported.|After every cycle (median duration on study = 4 cycles)|Analysis was performed patients receiving single agent cediranib or combination of cediranib plus dasatinib.|||Participants|||Count of Participants
1400375|NCT01260688|Secondary|Number of Participants With Toxicities|Incidence of toxicities graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0|Up to 30 days after last dose of study drugs||||participants|||Number
1400376|NCT01260688|Primary|12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2)|Progression is defined using the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, which includes a compilation of prostate-specific antigen (PSA), bone scan, and CT-scan assessments (Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 months|All patients were included in the analysis for 12-week PFS.|||participants|||Number
1400377|NCT01260662|Secondary|Procedural Recall|After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.|Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||percentage report recall of procedure|||Number
1400378|NCT01260662|Secondary|Respiratory Depression|Continuous capnographic monitoring|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||number of respiratory depression events|||Number
1400379|NCT01260662|Primary|Hypoxia|Pulse oximetry|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||Patients which experienced hypoxia|||Number
1400380|NCT01260662|Primary|Clinical Interventions During Sedation|Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation|From start of sedation procedure to end of sedation procedure, up to 24 hours|100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm|||Clinical interventions performed|||Number
1400381|NCT01260649|Secondary|Number of Participants With Cognitive Side Effects|will compare the incidence of participants with memory deficits between groups, as determined by incidents of clinician reported cognitive adverse events|3 months||||Participants|||Count of Participants
1400382|NCT01260649|Primary|Change in Hamilton Depression Rating Scale - 28|"HAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms.~The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms."|baseline, one month||||units on a scale||Standard Deviation|Mean
1400383|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Cmax of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers||After dose on Day 10 of Active Treatment Periods 1 and 2|1 clopidogrel smoker was not evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1400384|NCT01260584|Secondary|Characterization of the Pharmacokinetics (PK) Area Under Curve (AUC)(0-Last) of the Active Metabolite of Prasugrel and the Active Metabolite of Clopidogrel in Smokers and Non-smokers|Blood samples for determination of plasma concentrations of the prasugrel active metabolite, clopidogrel active metabolite, and clopidogrel inactive metabolite will be collected following the administration of the 10th (last) maintenance dose of each of the 2 Active Treatment Periods at 0.5, 1, 2, 4, and 6 hours post-dose.|After dose on Day 10 of Active Treatment Periods 1 and 2|1 Clopidogrel smoker participant was not evaluable for this measure.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1400385|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on Platelet Reactivity Index (PRI) <= 50%|Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.|||% participants with PRI <=50%|||Number
1400386|NCT01260584|Secondary|Responder Rate by Treatment and Smoking Status Based on P2Y12 Reaction Units (PRU) <= 235||Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker participant was not evaluable for this measure.|||% participants with PRU <=235|||Number
1400387|NCT01260584|Secondary|Assessment of Vasodilator Stimulated Phosphoprotein (VASP) by Treatment and Smoking Status|Day 10 occurs in each treatment period at which time data collections are made. Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose.|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.|||% vasodilator stimulated phosphoprotein||Standard Error|Least Squares Mean
1400388|NCT01260584|Secondary|Assessment of P2Y12 Reaction Units (PRU) by Treatment and Smoking Status|"Day 10 occurs in each treatment period at which time data collections are made. 12.1.4. Responders and Poor Responders~Numerous studies have established an association between high on-treatment platelet reactivity with clopidogrel and an increased risk for post-PCI ischemic events. In this study, the percentages of “responders” and “poor responders” following treatment with prasugrel and clopidogrel were compared. Poor responders were defined based on an Accumetrics VerifyNow PRU >235 and a VASP PRI >50%, as assessed 24 hours after the 9th maintenance dose."|Day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.|||P2Y12 reaction unit||Standard Error|Least Squares Mean
1400389|NCT01260584|Primary|Inhibition of Platelet Aggregation (IPA) in Prasugrel-treated and Clopidogrel-treated Smokers and Non-smokers Following 9 Days of Maintenance Therapy.|IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).|Baseline to day 10 for Active Treatment Periods 1 and 2|1 prasugrel smoker was unevaluable for this measure.|||percentage of device derived inhibition||Standard Error|Least Squares Mean
1400390|NCT01260493|Primary|Satisfaction With Health and Social Care||1 year|||||||
1400391|NCT01260493|Primary|Dependence in Activities of Daily Living|Changes in number of person dependent in one or more daily activity from baseline to follow-up.|1 year||||participants|||Number
1400392|NCT01260493|Primary|Health Care Consumption|Number of hospital days and admission will be analysed|1 year|||||||
1400393|NCT01260467|Secondary|Number of Participants With Adverse Events|This study will look at the number of participants who develop adverse events or side effects thought to be related to the memantine.|24 months||||participants|||Number
1400394|NCT01260467|Primary|6 Month Progression-free Survival||24 months|not evaluated due to poor patient accrual||||||
1400395|NCT01260467|Primary|Overall Survival||30 months|not evaluated due to poor patient accrual||||||
1400396|NCT01260454|Secondary|Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change|We counted the number of participants who used any amount of narcotic during the 14 day diary period.|14 days|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.|||participants|||Number
1400545|NCT01259102|Secondary|Period 1: Cmax0-7|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
1400397|NCT01260454|Secondary|Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score|Qutenza has not previously been used in patients with normal, healthy skin. We will assess the reaction to capsaicin in these patients as compared to the patients with unhealthy skin (post-herpetic neuralgia) who were studied in the registration trials for Qutenza. Pain immediately following Qutenza application was measured on a 10 point visual analog score with the word 'none' above 0 and 'agonizing' above 10.|60 minute period of patch application and subsequent 3 days||||participants|||Number
1400398|NCT01260454|Primary|Pain Score on a Visual Analogue Scale|"Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded 0 for two consecutive days.~The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10)."|14 days after a new infusion site|One subject did not meet the inclusion criteria and was excluded from the efficacy analysis.|||Visual Analogue Scale||Standard Deviation|Mean
1400399|NCT01260350|Secondary|Percentage of Participants With Virologic Failure|"The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.~On-treatment virologic failure was defined as:~Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),~Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or~Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)~Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit."|Up to Posttreatment Week 24|Safety Analysis Set|||percentage of participants|||Number
1400400|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.|Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1400401|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Baseline to Week 8|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1400402|NCT01260350|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline to Week 6|Safety Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1400403|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 12|Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.|Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
1400404|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 8|Data are not presented for Group 21 which ended treatment after Week 6.|Week 8|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
1400405|NCT01260350|Secondary|Percentage of Participants With HCV RNA < LOD at Week 6||Week 6|Safety Analysis Set|||percentage of participants|||Number
1400406|NCT01260350|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.|Posttreatment Week 12|Safety Analysis Set|||percentage of participants|||Number
1400407|NCT01260350|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Up to 12 weeks plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study medication.|||Percentage of participants|||Number
1400408|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].|||incidence rate ratio||95% Confidence Interval|Number
1400409|NCT01260324|Primary|Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)|Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.|01-January-2003 up to 31-December-2007|Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].|||incidence rate ratio||95% Confidence Interval|Number
1400410|NCT01260324|Primary|Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)||01-January-2003 up to 31-December-2007|Participants from the NAION cases population adjudicated by medical record review.|||participants|||Number
1400411|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use|Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
1400412|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
1400413|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors|Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.|01-January-2003 up to 31-December-2007|Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years]. Only the covariates selected by the step wise regression procedure were summarized.|||incidence rate per 1000 person-years||95% Confidence Interval|Number
1400414|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
1400415|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
1400416|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.|01-January-2003 up to 31-December-2007|Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
1400417|NCT01260324|Primary|Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age|Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.|01-January-2003 up to 31-December-2007|Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years [(NAION cases n, Controls n) / person-years].|||incidence rate per 1000 person-years||95% Confidence Interval|Number
1400418|NCT01260311|Other Pre-specified|Patient Perception of Bladder Condition (PPBC) at Week 4 and Week 8|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
1400419|NCT01260311|Other Pre-specified|Number of UUI Episodes Per 24 Hours at Week 4 and Week 8|UUI episodes were defined as those with USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
1400420|NCT01260311|Other Pre-specified|Number of Urgency Episodes Per 24 Hours at Week 4 and Week 8|Urgency episodes were defined as micturitions with USS rating of greater than or equal to (>=) 3. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
1400421|NCT01260311|Other Pre-specified|Number of Micturitions Per 24 Hours at Week 4 and Week 8|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with Urinary Sensation Scale (USS) rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Week 4 and Week 8|This efficacy outcome measure was removed in Protocol Amendment 1 and thus data was not collected.||||||
1400434|NCT01260194|Secondary|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population included all participants who had received at least 1 dose of study drug.|||participants|||Number
1400422|NCT01260311|Primary|Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment|Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).|Baseline up to 28 days after last dose|Safety population defined as all participants who received at least one dose of study medication.|||participants|||Number
1400423|NCT01260272|Secondary|Change in High Density Lipoprotein Cholesterol Levels|Raisin versus snacks: percent change in high density lipoprotein cholesterol levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
1400424|NCT01260272|Secondary|Change in Waist Circumference|Raisin versus snacks: change in waist circumference from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||cm||Standard Error|Mean
1400425|NCT01260272|Primary|Percent Change in Body Weight|Raisin versus snacks: percent change in body weight from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
1400426|NCT01260272|Primary|Percent Change in Fasting Glucose Levels|Raisins versus snacks: percent change in fasting glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||95% Confidence Interval|Median
1400427|NCT01260272|Secondary|Change in Hemoglobin A1c|Raisin versus snacks: change in hemoglobin A1c from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
1400428|NCT01260272|Secondary|Change in Diastolic Blood Pressure|Raisin versus snacks: change in diastolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||mmHg||Standard Error|Mean
1400429|NCT01260272|Secondary|Change in Systolic Blood Pressure|Raisin versus snacks: change in systolic blood pressure from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||mmHg||Standard Error|Mean
1400430|NCT01260272|Primary|Percent Change in Postprandial Glucose Levels|Raisins compared with snacks: percent change in postprandial glucose levels from baseline to week 12|12 weeks|Total # for analysis may not equal the randomized #. A last observation carried forward approach was utilized for those who did not complete the study, and who had at least 1 post treatment value. Subjects without at least 1 post treatment values were not included in the analysis. The analysis # was also adjusted by excluding defined outliers.|||Percent change from baseline||Standard Error|Mean
1400431|NCT01260194|Secondary|Number of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Gastric Cancer|The HER2 status was determination by using immunohistochemistry (IHC) and confirmatory Fluorescent In Situ Hybridization (FISH) techniques. Only participants with HER2 positivity were allowed to receive study medication.|Baseline|Safety population.|||participants|||Number
1400432|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|The LVEF was measured using Multi Gated Acquisition (MUGA) or echocardiography (echocardiography was preferred), using the same technique throughout for consistency in an individual participant. Baseline LVEF assessments were done within 21 days prior to the start of treatment. Participants with clinically significant change from baseline (that is, absolute drop in LVEF of >=15%, and drop to a value <50%) have been reported.|Baseline, thereafter every 12 weeks (maximum up to 22 months)|Safety population.|||participants|||Number
1400433|NCT01260194|Secondary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Lab parameters assessed during the study were serum chemistry, biochemistry - serum electrolytes, hematology, 12 lead electrocardiogram, and urinalysis – protein, glucose, blood and other lab tests. Laboratory tests were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 3.|Baseline up to 6 month after last dose of study drug (maximum up to 22 months)|Safety population.|||participants|||Number
1400466|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the IDRB.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
1400467|NCT01259713|Secondary|Percentage of Participants Requiring Antifungal Treatment During Remission-Induction Chemotherapy||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
1400435|NCT01260194|Secondary|Duration of Response (DR)|DR was based on RECIST criteria v1.1 and was defined as time from date the CR or PR was first recorded to the date on which PD was first noted. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions and/or appearance of 1 or more new lesions. For the participants with no documented progression after CR or PR, the censored date (the date of “death,” the “last tumor measurement,” “last date in drug log,” or “last follow-up”) was taken into consideration. The median duration of response with 95% CI was estimated using Kaplan Meier method.|Baseline up to PD or death (maximum up to 22 months)|ITT population. The number of participants analyzed signifies the number of participants analyzed for this outcome measure.|||days||95% Confidence Interval|Median
1400436|NCT01260194|Secondary|Percentage of Participants With Clinical Benefit Response (CBR)|CBR was defined as any response among stable disease (SD) for 6 weeks or longer, CR, or PR as determined by the RECIST v 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to PD or death (maximum up to 22 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1400437|NCT01260194|Secondary|Percentage of Participants With Overall Tumor Response|Overall tumor response was defined as the occurrence of either a confirmed complete response (CR) or a partial response (PR) as best overall response as determined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version (v) 1.1 from confirmed radio-graphic evaluations of target and non-target lesions. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease; all nodes, both target and non-target, must decrease to normal (short axis less than [<]10 mm); no new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions (the short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions); no unequivocal progression of non-target disease; no new lesions.|Baseline up to PD or death (maximum up to 22 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1400438|NCT01260194|Secondary|Overall Survival (OS)|OS was defined as the time from the date of enrollment to the date of the death (from any cause). If no death was observed, censored observations were taken into account in the analysis. The censoring date was the last date of “last tumor measurement,” “last date in drug log,” or “last follow-up.” The median overall survival time with 95% CI was estimated using Kaplan Meier method.|Baseline up to death (maximum up to 22 months)|ITT population.|||days||95% Confidence Interval|Median
1400439|NCT01260194|Primary|Median Progression Free Survival (PFS)|The PFS was defined as the median time between the day of enrollment and the first documentation of progressive disease (PD) or date of death, whichever occurred first. PD was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeters [mm]) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The censoring date was the last date of “last tumor measurement,” “last date of study drug treatment,” or “last follow-up.” The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method.|Baseline up to PD or death (maximum up to 22 months)|ITT population.|||days||95% Confidence Interval|Median
1400440|NCT01260142|Secondary|Relative Bioavailability of Fospropofol and Propofol|The PK parameters for propofol from propofol injectable emulsion were used as the reference formulation. Because propofol is a metabolite of fospropofol, all calculations were conducted after correcting for the different molecular weights of these formulations. Molecular weights of 332.24 (288.24 for free base) and 178.27 were used for fospropofol disodium and propofol injectable emulsion, respectively. The propofol parameters were adjusted as appropriate as discussed above and natural log transformed prior to comparison. Relative bioavailability of propofol from fospropofol disodium (E2083) to propofol from propofol injectable emulsion is calculated as (AUC(FP) x Total Dose of Propofol/AUC(P) x Total Dose of E2083) x Molecular fraction, where AUC(FP) is AUC(0-t) or AUC(0-inf) of propofol from E2083, AUC(P) is AUC(0-t) or AUC(0-inf) of propofol from propofol injectable emulsion and molecular fraction is molecular weight of propofol (178.27)/E2083 (332.24).|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ng x hr/mL||Standard Deviation|Mean
1400441|NCT01260142|Secondary|Maximal Sedative Effect Using the Modified Observer's Assessment of Alertness/Sedation Scale|PD effects were determined from continuous BIS score recordings and from clinical assessment of sedation using the MOAA/S scale. The MOAA/S scale was used to rate the level of alertness/sedation from a score of 0 (does not respond to painful stimulus) to 5 (alert) in the category of responsiveness, with 5 being the MOAA/S value for a fully awake adult. Time to sedation was defined as the time from the first dose of study medication to the first two consecutive MOAA/S scores less than or equal to 4. Fully awake status was reached at the first of 3 consecutive MOAA/S scores of 5 measured every 2 minutes after study drug administration. The MOAA/S scale was described by the Emax model.|Days 1, and 7-14 (2 minutes prior to study drug administration and every 2 minutes thereafter for 20 minutes or until the subject reached Fully Alert status, whichever was later).|PD Analysis Set|||Scores on a scale||Standard Deviation|Mean
1400502|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy|End of 4-week intervention|Two SIP subjects had missing data for this variable.|||percentage of time in bed spent asleep||95% Confidence Interval|Mean
1400442|NCT01260142|Secondary|Maximal Sedative Effect Using the Bispectral Index (BIS) Score|Pharmacodynamic (PD) effects were obtained from continuous BIS score recordings obtained throughout the study and from clinical assessment of sedation using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale. The BIS measurements continued until the participant was fully recovered in the opinion of the investigator or until the PD effect measure returned to baseline. The BIS score varied between 100 (associated with being fully awake) and 0 (associated with a flat line on the electroencephalogram (EEG)). The BIS Index was described by the maximal effect (Emax) model.|Days 1, and 7-14 (BIS measurements were to continue until the subject was fully recovered in the opinion of the investigator or until the PD effect measures returned to baseline measures)|PD analysis set included all participants who had sufficient PD data to derive at least one PD assessment.|||Scores on a scale||Standard Deviation|Mean
1400443|NCT01260142|Primary|Maximum Drug Plasma Concentration of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug/mL||Standard Deviation|Mean
1400444|NCT01260142|Primary|Maximum Drug Plasma Concentration (Cmax) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. Cmax was the highest plasma drug concentration observed over the entire sampling period, and was obtained directly from the experimental plasma concentration time data without interpolation. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug/mL||Standard Deviation|Mean
1400445|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t of Propofol|Arterial and venous blood samples were collected and analyzed for propofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to Cmax, log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug.h/L||Standard Deviation|Mean
1400446|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC(0-t)) of Fospropofol|Arterial and venous blood samples were collected and analyzed for fospropofol concentrations as described previously. AUC(0-t) was calculated using the log-linear trapezoidal rule (linear trapezoidal rule up to maximum observed plasma concentration (Cmax), log trapezoidal rule following Cmax) from time of dosing to the last quantifiable concentration. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug.h/L||Standard Deviation|Mean
1400447|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Propofol|An A-line and V-line were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of propofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC(0-t) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling. In addition, the arterial plasma concentrations of fospropofol, propofol liberated from fospropofol, and propofol delivered from propofol injectable emulsion were used to refine the population PK model developed previously.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|PK Analysis Set|||ug.h/L||Standard Deviation|Mean
1400448|NCT01260142|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Fospropofol (AUC(0-inf))|AUC(0-inf) is a measure of drug concentration equal to the area under the plasma concentration-time profile from time 0 to infinity. An arterial line (A-line) and venous line (V-line) were placed prior to dosing during each treatment period and used to collect blood samples for plasma concentration measurements at specific time points. Plasma arterial and venous concentrations of fospropofol were quantified by high-performance liquid chromatography with mass spectrometric detection (LC-MS/MS). The AUC(0-inf) was calculated from the sum of AUC from time 0 to time t (AUC(0-t)) and the residual area calculated as Ct/λz, where Ct was the observed concentration at last quantifiable concentration and λz was the terminal elimination rate constant. The plasma concentrations from the venous sampling were descriptively compared head-to-head with the arterial sampling.|Days 1, and 7-14 (Arterial Sample: Pre-dose, and 0.5, 1, 1.5, 2, 4, 8, 16, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose. Venous Sample: Pre-dose, and 1, 4, and 30 minutes post-dose).|Pharmacokinetic (PK) Analysis Set is the group of participants who have sufficient pharmacokinetic data to derive at least one PK parameter.|||ug.h/L||Standard Deviation|Mean
1400449|NCT01259856|Secondary|Number of Participants With Major Cardiovascular Events After Therapy||4 years||||Participants|||Count of Participants
1400450|NCT01259856|Secondary|Number of Participants With Progression of Disease|"survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy~To estimate survival and incidence of development of myelodysplastic syndrome, myelofibrosis, or leukemic transformation after therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea).~We plan to capture the rate of progression to a more advanced myeloid malignancy."|4 years||||Participants|||Count of Participants
1400451|NCT01259856|Secondary|Allele Burden|The impact of PEGASYS on JAK2 will be measured by the allele burden; hematopoietic cell clonality will be measured by whether patients with clonal disease return to polyclonal; bone marrow histopathology will be measured by going from abnormal to normal; cytogenetic abnormalities will be measured by seeing if the cytogenetics go from abnormal to normal.To compare the impact of therapy on JAK2-V617F (JAK2), CALR, hematopoietic cell clonality in platelets and granulocytes in females, bone marrow histopathology, and cytogenetic abnormalities.|4 years|data not collected||||||
1400452|NCT01259856|Secondary|JAK2 Allele Burden|To compare the impact of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea) on key biomarkers of the disease(s) by measuring the JAK2 allele burden.|4 years|data not collected||||||
1400453|NCT01259856|Secondary|Change in the Total Symptom Score (TSS)|Change in the Total Symptom Score which assessed improvement in disease symptoms measured by the change in TSS from the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) instrument being used in this study from baseline to 12 months. This 19 item instrument includes the previously validated 9 item brief fatigue inventory (BFI), symptoms related to splenomegaly, inactivity, cough, night sweats, pruritus, bone pains, fevers, weight loss, and an overall quality of life assessment. Each item is scored from 0-10 with full scale from 0-1900, with higher scores mean worse symptoms.|baseline and 12 months||||score on a scale||Full Range|Mean
1400454|NCT01259856|Secondary|Number of Participants With Grade 3 and Grade 4 Hematological and Non-hematological Events|Number of Participants with Grade 3 and Grade 4 Hematological and Non-hematological Events using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0 to assess the toxicity, safety and tolerability of therapy (Pegylated Interferon Alfa-2a vs. Hydroxyurea).|4 years||||Participants|||Count of Participants
1400455|NCT01259856|Primary|Number of Participants With Partial Remission (PR)|Number of participants with Partial Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET).|12 months||||Participants|||Count of Participants
1400456|NCT01259856|Primary|Number of Participants With Complete Remission (CR)|Number of participants with Complete Remission after 12 months of therapy assessed by hematologic response rates two strata of patients with high risk polycythemia vera (PV) or high risk essential thrombocythemia (ET).|12 months||||Participants|||Count of Participants
1400457|NCT01259726|Secondary|Time to First CDI Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (<50%) with CDI recurrence, median time to event was not evaluable.|Baseline (Day 1) up to Week 6|ITT-S population|||days||Full Range|Median
1400458|NCT01259726|Secondary|Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools|Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.|Baseline (Day 1) up to Week 6|ITT-S population.|||Participants|||Number
1400459|NCT01259726|Secondary|Number of Participants With Use of Antibacterial Treatment for CDI|Any antibacterial medication used after Day 1 for which the investigator selected the indication “antibacterial for C. difficile infection”.|Baseline (Day 1) up to Week 6|ITT-S population.|||Participants|||Number
1400460|NCT01259726|Secondary|Number of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence was defined as at least 1 event characterized by ALL of the following: >=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.|Baseline (Day 1) up to Week 6|ITT-S population.|||Participants|||Number
1400461|NCT01259726|Primary|Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3||After study drug administration period (14 days) through Week 6|ITT-S population.|||Participants|||Number
1400462|NCT01259726|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.|Baseline up to 7 days after the last dose of study drug (up to Week 3)|Intent-to-Treat-Safety (ITT-S) population was defined as all randomized participants who received at least 1 dose of study drug.|||Participants|||Number
1400463|NCT01259713|Secondary|Percentage of Participants With Complete Remission at the End of Remission Induction|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
1400464|NCT01259713|Secondary|Time From Beginning of Remission-induction Chemotherapy Until the Beginning of Consolidation Therapy|This endpoint was to evaluate the potential impact of IFI prevention on the efficacy of remission-induction chemotherapy for ALL.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||days||Inter-Quartile Range|Median
1400465|NCT01259713|Secondary|Percentage of Participants Who Died Due to Fungal Infection; Causality as Assessed by the Investigator.||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
1400468|NCT01259713|Secondary|Time to Diagnosis of Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the IDRB.|Time to diagnosis of proven or probable IFIs is presented as the median (Q1,Q3) days to diagnosis of those participants who experienced a proven or probable IFI. Median was not reached if < 50% of participants had an event; Q1 was not reached if < 25% of participants had an event; Q3 was not reached if < 75% of participants had an event.|During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||days||Inter-Quartile Range|Median
1400469|NCT01259713|Secondary|Percentage of Participants Diagnosed With Proven or Probable IFIs According to the EORTC/MSG Criteria, as Assessed by the Investigator||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
1400470|NCT01259713|Secondary|Percentage of Participants With Pulmonary Infiltrates According to the Central Image Reader||During remission-induction chemotherapy (average 7 weeks)|ITT Analysis Set|||percentage of participants|||Number
1400471|NCT01259713|Primary|Percentage of Participants With Proven or Probable IFIs During Remission-induction Chemotherapy for Acute Lymphoblastic Leukemia (ALL)|"Diagnoses of proven or probable invasive fungal infections (IFI) were assessed according to European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria by the independent data review board (IDRB) who were blinded to treatment assignment.~The duration of remission-induction chemotherapy was defined as the period from the initiation of remission-induction chemotherapy administration to the start of consolidation or salvage therapy."|During remission-induction chemotherapy (average 7 weeks)|Intent-to-Treat (ITT) Analysis Set: participants in the safety analysis set who had no major violations of entrance criteria.|||percentage of participants|||Number
1400472|NCT01259596|Secondary|Changes From Baseline in Generalized Anxiety Disorder-7 (GAD-7) to Week 13|Diagnostic and Statistical Manual of Mental Disorders, IV edition (DSM-IV0) symptoms of Generalized Anxiety Disorder; scores range from 0 to 24 with higher scores indicating greater symptoms of GAD; higher score represents worse outcome|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
1400473|NCT01259596|Secondary|Insomnia Severity Index (ISI)|self-report symptoms of insomnia; scores range from 0 to 28 with higher scores indicating greater symptoms of sleep disturbance; higher score represents worse outcomes|week 13||||units on a scale||95% Confidence Interval|Mean
1400474|NCT01259596|Secondary|Short Form (36) Health Survey (SF-36) to Week 13|physical and emotional health related quality of life; The SF-36 is a self-report measure of health-related quality of life (HRQL) consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy, emotional well-being, and general health perceptions. These 8 subscales are also combined into two domains: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). All of these scales range from 0 (maximum impairment) to 100 (no impairment). A lower score represents worse outcome.|week 13||||units on a scale||95% Confidence Interval|Mean
1400475|NCT01259596|Secondary|Pepper Center Tool for Disability (PCT-D)|self report measure of perceived difficulties with mobility and performing basic and advanced activities of daily living; the scale consists of 19 items; scores range from 19 to 114, with higher scores indicating more disability. Higher scores represent worse outcome.|week 13||||units on a scale||95% Confidence Interval|Mean
1400476|NCT01259596|Secondary|Changes From Baseline in Beck Depression Inventory (BDI) at 13 Weeks|self report measure of depressive symptoms; scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms Higher scores represent worse outcome.|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
1400477|NCT01259596|Primary|Changes From Baseline in Hamilton Anxiety Rating Scale (HAM-A) at Week 13|interviewer-rated severity of anxiety symptoms; the scores range from 0 to 56, with higher scores representing higher severity of anxiety. Higher scores represent worse outcome.|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
1400478|NCT01259596|Primary|Changes From Baseline in Penn State Worry Questionnaire (PSWQ-A) at Week 13|self-reported severity and frequency of worry the scores range from 8 to 40, with higher scores representing higher severity of worry. Higher scores represent worse outcome.|baseline to week 13||||units on a scale||95% Confidence Interval|Mean
1400479|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment|"The ASRS is a self-rating scale designed to assess ADHD symptoms in adults and is now part of the World Health Organization Composite International Diagnostic Interview. It consists of 18 items written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often). The total score ranges from 0 to 72."|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a scale||Standard Deviation|Mean
1400480|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment|CAARS is an instrument to assess ADHD symptoms and behaviors in adults. This study utilizes the Observer Short Version (CAARS-O: S), consisting of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index (to distinguish ADHD adults from non-clinical adults), and Inconsistency Index (to identify random or careless responding) and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The observer is asked to notice the patient carefully and decide how much or how frequently each of the 26 items of the scale describes the patient recently. The response to every question in increasing order of severity is “not at all, never = 0; Just a little, once in a while = 1; Pretty much, often = 2; Very much, very frequently = 3”. The total score combined from all the 26 items ranges from 0 to 88.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a scale||Standard Deviation|Mean
1400503|NCT01259375|Secondary|Differential Response to Amurbicin Among Certain Histologic Subtypes of Sarcoma.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|48 months||||participants|||Number
1400481|NCT01259492|Secondary|Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|CGI-S assesses the patient’s current illness state. CGI-S consists of 7 ratings that range from 1 = “normal, not at all ill” , 2 = “borderline mentally ill”, 3 =” mildly ill”, 4 = “moderately ill”, 5 = “markedly ill”, 6 = “severely ill”, 7 = “among the most extremely ill patients”|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.|||Participants|||Number
1400482|NCT01259492|Secondary|Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment|On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is “no change”, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = “Very much improved” to 7 =“Very much worse”. Improvement on the CGI-I scale is defined as a visit rating of 1 “very much improved” or 2 “much improved” on the CGI-I scale.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included.|||participants|||Number
1400483|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment|The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient’s work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more “impaired” a patient’s work, social life, family life is.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a Scale||Standard Deviation|Mean
1400484|NCT01259492|Secondary|Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment|The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54.|Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks)|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo.|||Units on a Scale||Standard Deviation|Mean
1400485|NCT01259492|Secondary|Number of Participants With Clinical Global Impression – Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14)|CGI-S assesses the patient’s current illness state. CGI-S consists of 7 ratings that range from 1 = “normal, not at all ill” , 2 = “borderline mentally ill”, 3 =” mildly ill”, 4 = “moderately ill”, 5 = “markedly ill”, 6 = “severely ill”, 7 = “among the most extremely ill patients”|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2; Patients with CGI-S assessment both at Baseline 1 and Period 2 was included.|||number of participants|||Number
1400486|NCT01259492|Secondary|Number of Participants With Clinical Global Impression – Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14)|CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = “very much improved”, 2 = “much improved”, 3 = “minimally improved”, 4 = “no change from baseline”, 5 = “minimally worse”, 6 = “much worse” 7 = “very much worse”|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2 Patients with CGI-I assessment both at Baseline 1 and Period 2 was included.|||number of participants|||Number
1400487|NCT01259492|Secondary|Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners’ Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14)|"DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 (Never) to 4 (Very often)."|Baseline 1 to End of Period 2 (Week 14)|Full Analysis Set for Period 2 (FAS P2) – all randomized patients who took one dose of study medication in Period 2|||Score on Scale||Standard Deviation|Mean
1400488|NCT01259492|Secondary|Percentage of Patients With Improvement on Clinical Global Impression – Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1|On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is “no change”, scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = “Very much improved” to 7 =“Very much worse”. Improvement on the CGI-I scale is defined as a visit rating of 1 “very much improved” or 2 “much improved” on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N * 100.|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Evaluable patients with both baseline and post-baseline (end of week 9) assessments were included.|||Percentage of Patients|||Number
1400489|NCT01259492|Primary|Percentage of Participants With Treatment Failures During Period 3|Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 – DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) >= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 – DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) > - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54|Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40|Full Analysis Set for Period 3 (FAS P3) – all re-randomized patients who take one dose of study medication in period 3. One patient in Ritalin LA 80mg did not have post baseline 2 measurements and was not included in the categories under without imputation.|||Percentage of participants|||Number
1400490|NCT01259492|Primary|Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment|SDS, a 5-self-rated questionnaire to measure the extent a pt’s disability due to an illness/health problem interferes with work/school, social life/leisure, family life/home. First 3 items, pts are asked how their symptoms disrupted their reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. subscale(work disability, social life disability, family life disability) can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairmt. Subscale scores >5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.|||Units on a Scale||Standard Deviation|Mean
1400491|NCT01259492|Primary|Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (Never) to 4 (Very often). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 – DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) <= - 30%."|Baseline 1 to End of Period 1 (Week 9)|Full Analysis Set for Period 1 (FAS P1) – all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included.|||Units on a Scale||Standard Deviation|Mean
1400492|NCT01259466|Secondary|Percent Weight Change|% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100|Post-treatment (12 weeks)||||Percent weight change||Standard Deviation|Mean
1400493|NCT01259466|Primary|Number of Participants With Verified Smoking Cessation (Abstinence)|Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)|Post-treatment (12-weeks)||||participants|||Number
1400494|NCT01259440|Primary|Treatment Adherence|Nightly CPAP adherence measured over the two-month period .|2 months||||hours/night||Standard Deviation|Mean
1400495|NCT01259427|Secondary|Social Engagement/Withdrawal|The total score of the Social Engagement/Withdrawal subscale of the Social Functioning Scale was used to measure social engagement. The total score ranges from 0 to 15 with higher scores indicating greater social engagement.|~3 1/2 months (post-treatment)||||unit on a scale||Standard Deviation|Mean
1400496|NCT01259427|Secondary|Quality of Life|The Satisfaction with Life in General item from the Brief Quality of Life Scale was used to assess self-reported life satisfaction. The item is rated on a 7-point scale that ranges from terrible to delighted (range=1 to 7), with greater scores indicating more satisfaction.|~3 1/2 months (post-treatment)||||units on a scale||Standard Deviation|Mean
1400497|NCT01259427|Primary|Sense of Belonging Instrument (Belonging)|The Sense of Belonging Instrument was used to measure perceived belongingness. The measure includes two subscales: the psychological experience of belonging (SOBI-P) and antecedents that foster belonging (SOBI-A). An average of the sum of the items in each subscale were used to calculate the total score for that subscale. The total score of the SOBI-P ranges from 18 to 72, with higher scores indicating less experienced belonging. The total score of the SOBI-A ranges from 14-56 with higher score indicating greater antecedents that foster belonging.|~3 1/2 months (post-treatment)||||units on a scale||Standard Deviation|Mean
1400498|NCT01259427|Primary|General Self-Efficacy Scale|The General Self-efficacy measure was used to measure of self-efficacy. A total score was calculated by averaging the responses on the items (range=1 to 5), with higher scores indicating greater self-efficacy.|~3 1/2 months (post-treatment)||||unit on a scale||Standard Deviation|Mean
1400499|NCT01259427|Primary|Maryland Assessment of Recovery for Serious Mental Illness Scale (Recovery)|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~3 1/2 months (post-treatment)||||units on a scale||Standard Deviation|Mean
1400500|NCT01259427|Primary|Internalized Stigma of Mental Illness Inventory (Internalized Stigma)|The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.|~3 months (post-treatment)||||units on a scale||Standard Deviation|Mean
1400501|NCT01259401|Primary|Sleep Efficiency|Percentage of time asleep while in bed estimated by actigraphy.|4-month follow-up|Two SIP subjects had missing data for this variable.|||percentage of time in bed asleep||95% Confidence Interval|Mean
1400504|NCT01259375|Secondary|Quality of Response With Radiographic Evaluation Using Both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi Criteria.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Exploratory CT evaluations according to Choi response criteria will be also performed and correlated with RECIST response.|48 months|This exploratory objective was not assessed.||||||
1400505|NCT01259375|Secondary|Overall Survival|This variable reviews the percentage of Overall Survival at 24 months and presents the percentage of participants who survived at 2 years.|two years||||percentage of participants||95% Confidence Interval|Number
1400506|NCT01259375|Secondary|Number of Participants With Serious Adverse Events||4 months|One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response, but was evaluable for safety and toxicity.|||participants who experienced an SAE|||Number
1400507|NCT01259375|Primary|Progression Free Survival|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1) for target lesions and assessed by CT; time elapsed between treatment initiation and tumor progression or death. In target lesions, progression is defined per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In non-target lesions, progression is defined via RECIST v 1.1 as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|six months||||percentage of pt with 6 mnth PFS||95% Confidence Interval|Number
1400508|NCT01259375|Primary|Response Rate for Amrubicin in Patients With Metastatic or Advanced Sarcoma as First Line Therapy.|Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|48 months|One patient discontinued study treatment after the first cycle due to side effects and was not evaluable for response.|||percentage of pt with a partial response||95% Confidence Interval|Number
1400509|NCT01259297|Secondary|Number of Participants With Total Mortality in Aliskiren Based Regimen Versus Non-aliskiren Based Regimen|The total mortality endpoint was defined as time to death from any cause. Total mortality analysis used the date of last follow-up including the washout period as the censoring date.|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||Participants|||Number
1400510|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Mean sitting diastolic blood pressure (msDBP) is the average of 2 sitting DBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.|||mmHg||Standard Error|Least Squares Mean
1400511|NCT01259297|Secondary|Number of Participants With Renal Dysfunction in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|"The renal dysfunction (composite endpoint) was defined as the first occurrence of either of the following:~End-stage renal disease [ESRD] requiring dialysis or transplantation~Doubling of serum creatinine and reaching an eGFR < 45 ml/min/1.73 m^2."|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. The duration of study follow-up was 209 days (median) as against the planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||participants|||Number
1400512|NCT01259297|Secondary|Percentage of Participants With Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part II)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE was comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in the last month. Each question’s score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)).~Part II of SAGE included 2 dimensions:~Normal if the scores of all SAGE questions is 0 (i.e., No difficulty)~Mobility Only if scores of both SAGE questions 11 and 12 are 0"|End of study (209 days [median])|Full Analysis Set. Number of patients with all SAGE questions non-missing for the specific visit are included in this population. Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn.|||percentage of participants|||Number
1400513|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||participants|||Number
1400514|NCT01259297|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Mean sitting systolic blood pressure (msSBP) is the average of 2 sitting SBP measurements (2 minutes apart). Since each patient had their final follow-up visit at a different time in the trial, these measurements were classified as falling into the 6 week, 6 month, or 12 month measurement period. All available blood pressures were sorted within these periods and the last value within each time range used for analysis. At each timepoint, a patient must have both baseline and postbaseline values to be included in the analysis.|Baseline (BL), 6 week, 6 month and 12 month|Full analysis Set : All randomized patients, regardless of receiving study medication. n=number of patients with non-missing assessments at baseline and each post-baseline visit.|||mmHg||Standard Error|Least Squares Mean
1400515|NCT01259297|Secondary|Change From Baseline to End of Study in Standard Assessment of Global Activities in the Elderly (SAGE) Dimensions (Part I)|"Decline in ability to perform everyday activities independently was measured primarily by using the Standard Assessment of Global Activities in the Elderly (SAGE) scale. The SAGE comprised of 15 questions, each describing an activity. Patient had to indicate how much difficulty he/she had encountered in performing the activity in last month. Each question’s score ranges from 0 (No difficulty) to 3 (difficulty levels were mild (score = 1), moderate (score =2) and severe (score=3)). Part I of SAGE included 4 dimensions:~Community Cognition (maximum of scores of questions 1 to 6);~Instrumental Activities of daily Living (IADL) (maximum of scores of questions 7 to 10);~Mobility (maximum of scores of questions 11 and 12);.~Basic Activities of daily Living (ADL) (maximum of scores of questions 13 to 15) Each dimension’s total score ranged from 0 to 3. 0=best, 3=worst A negative change in value from baseline means improvement in the ability to perform everyday activities."|Baseline, End of study (209 days [median])|Full Analysis Set: Due to the sparse post-baseline data following early termination of the study, this analysis was not performed as planned in protocol.Hence, no meaningful conclusion could be drawn. Patients who completed both baseline and post-baseline SAGE questionnaires (Part II) were included in this analysis.|||units on a scale||Standard Deviation|Mean
1400516|NCT01259297|Primary|Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen|The composite CV endpoint is based on the following first adjudicated events: CV death, non-fatal MI,non-fatal stroke, significant heart failure|End of study (209 days (median))|Full Analysis set. 1759 patients were randomized as against the originally planned 11,000. A total of 25 primary CV composite endpoints had accrued during median follow-up of 209 days versus planned 2000 primary endpoints during planned follow-up of average 5 years. These low numbers significantly limit interpretation of the results.|||participants|||Number
1400517|NCT01259284|Primary|Incidences of Atrial Fibrillation During First 4 Days After Lung Resection|New onset of sustained (15 min or >) or clinically significant (requiring intervention) atrial fibrillation (AF) during first 4 days post surgery as defined by on American College of Cardiology and American Heart Association Physician Consortium.|Baseline to 4 days post surgery|Analysis was to be per protocol. There is no analysis due to an inadequate number of enrolled participants in study which resulted in early termination.||||||
1400518|NCT01259245|Secondary|FEV1% Pred|Pred FEV1 percent predicted normal values;measured using spirometry|6 months post-intervention|Intention to treat|||percentage of FEV1 predicted||Standard Deviation|Mean
1400519|NCT01259245|Secondary|FEV1|Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry|6 months post-intervention|Intention to treat analysis|||liters||Standard Deviation|Mean
1400520|NCT01259245|Secondary|FVC|Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry|6 months post intervention|Intention to treat analysis|||liters||Standard Deviation|Mean
1400521|NCT01259245|Secondary|6 MWT in Meters|The 6 minute walking test ( 6MWT) was conducted according to protocol recommended by American Thoracic Society (ATS) guidelines to measure functional exercise capacity.This test measured the self paced distance in meters that a patient could quickly walk on a flat, hard surface in a period of 6 minutes.|6 months post-intervention|Intention to treat analysis|||meters||Standard Deviation|Mean
1400522|NCT01259245|Primary|SGRQ HKC Total|SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
1400523|NCT01259245|Primary|SGRQ HKC-Impact|SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|intention to treat|||units on a scale||Standard Deviation|Mean
1400524|NCT01259245|Primary|SGRQ HKC-Activity|SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
1400525|NCT01259245|Primary|SGRQ HKC-Symptoms|SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.|6 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
1400526|NCT01259245|Primary|Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)|The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients’ overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.|Change in SEMSOB at 6 months post-intervention|Intention to treat|||units on a scale||Standard Deviation|Mean
1400527|NCT01259245|Primary|Self Efficacy :COPD Self Efficacy Scale (CSES)|"34 item questionnaire consisting of likert scale with 5 responses ranging from 1 indicating  not at all confident to 5 indicating  very confident with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as not at all confident and 1 as very confident. The validated Chinese version of CSES was also used"|Change in CSES at 6 months post-intervention|Intention to treat was used in the analysis|||rating score of 0.2 to 1||Standard Deviation|Mean
1400528|NCT01259115|Secondary|The Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety assessments consisted of monitoring and recording medical history, physical examinations, vital signs (including temperature, heart rate, blood pressure and respiratory rate), reports of adverse experiences, and laboratory abnormalities (including electrocardiogram [ECG]).|The first day of study drug administration to 30 days after the last dose of study drug.|Safety Population: Safety analyses were performed on all subjects who received at least 1 dose of study drug and for whom at least 1 postdose safety observation was recorded.|||participants|||Number
1400529|NCT01259115|Primary|Cmax of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
1400530|NCT01259115|Primary|AUCinf of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.||||||
1400531|NCT01259115|Primary|AUCt of Buprenorphine-3-glucuronide With and Without Ketoconazole|"For buprenorphine-3-glucuronide pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
1400532|NCT01259115|Primary|Cmax of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
1400533|NCT01259115|Primary|AUCinf of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
1400534|NCT01259115|Primary|AUCt of Nor-buprenorphine Glucuronide With and Without Ketoconazole|"For nor-buprenorphine glucuronide pharmacokinetic metrics, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
1400535|NCT01259115|Primary|Cmax of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, Cmax (maximum observed plasma concentration), log transformed data were analyzed.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
1400544|NCT01259102|Secondary|Period 2: Cmax0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d.~Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
1400536|NCT01259115|Primary|AUCinf of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
1400537|NCT01259115|Secondary|CYP3A4 Inhibition by Observation of Plasma Nor-buprenorphine Production Assessed by the Erythromycin Breath Test.|As part of subject screening, Erythromycin Breath Tests (EBT) were done on all potential subjects (enrolled population). CYP 3A4 inhibition was calculated by taking the difference of the baseline 14C erythromycin metabolism, subtracting the 14C erythromycin metabolism during ketoconazole treatment, dividing this difference by the baseline 14C erythromycin metabolism, and multiplying by 100 to express results in the form of percent inhibition. CYP3A4 inhibition was only done when subjects were on ketoconazole.|One time at screening and one time during ketoconazole treatment|Enrolled Population: All subjects who participated in the study. CYP3A4 Inhibition was only done when subjects were on Ketoconazole.|||Percentage of participants||Standard Deviation|Mean
1400538|NCT01259115|Primary|AUCt of Nor-buprenorphine With and Without Ketoconazole|"For nor-buprenorphine pharmacokinetic metric, AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration).~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL*h||Standard Deviation|Mean
1400539|NCT01259115|Primary|Cmax of Buprenorphine With and Without Ketoconazole.|"Cmax (maximum observed plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral tablets twice daily,~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid PK metric.|||pg/mL||Standard Deviation|Mean
1400540|NCT01259115|Primary|AUCinf of Buprenorphine With and Without Ketoconazole.|"AUCinf (the area under the plasma-concentration time course profile from time 0 [dosing] to infinity) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.|||pg /mL•h||Standard Deviation|Mean
1400541|NCT01259115|Primary|AUCt of Buprenorphine With and Without Ketoconazole.|"AUCt (area under the plasma concentration-time curve from hour 0 to the last measurable plasma concentration) of buprenorphine transdermal patch 10 with and without ketoconazole 200 mg oral twice daily.~Period 1, subjects wore BTDS 10 patch between days 3 and 10 and took ketoconazole (200 mg orally twice daily) or ketoconazole placebo (orally twice daily) between days 1 and 11. Washout period of 4 to 18 days. Period 2, subjects wore BTDS 10 patch between days 19 and 26 and took ketoconazole (200 mg orally twice daily) or Ketoconazole placebo (orally twice daily) between days 17 and 27."|BTDS Days 3, 10, 19, and 26; ketoconazole or placebo Days 9 and 25|The full analysis population for pharmacokinetics was defined as those subjects who received at least 1 dose of study drug and did not have any incidents of emesis for at least 12 hours from dosing during at least 1 period and had at least 1 valid pharmacokinetic metric.|||pg/mL*h||Standard Deviation|Mean
1400542|NCT01259102|Secondary|Period 2: Tmax0-7d.|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||hour||Standard Error|Mean
1400543|NCT01259102|Secondary|Period 1: Tmax0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.~Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax."|0 to 7days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||hour||Standard Error|Mean
1400945|NCT01256008|Secondary|Visual Analogue Scale (VAS)|"The scale is used to assess the pain intensity of patients.~The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain.~The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline,4 w,8 w,12 w,24 w||||units on a scale||Standard Deviation|Mean
1400546|NCT01259102|Secondary|Period 2: AUC0-7d|"Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
1400547|NCT01259102|Secondary|Period 1: AUC0-7d.|"Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.~AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal."|0 to 7 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
1400548|NCT01259102|Primary|Period 2: Cmax0-3d|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
1400549|NCT01259102|Primary|Period 1: Cmax0-3d|"Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.~Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL||Standard Error|Mean
1400550|NCT01259102|Primary|Period 2: AUC0-3d.|"Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d.~AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)."|0 to 3 days|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
1400551|NCT01259102|Primary|Period 1: AUC0-3d|Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)].|0 to 3 days (72 hours)|Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.|||pg/mL*h||Standard Error|Mean
1400552|NCT01259063|Secondary|Activated mTOR (Mammalian Target of Rapamycin) Pathway Markers as Well as Phosphatase and Tensin Homolog (PTEN) Status and Serine/Threonine Kinase (AKT) Activation Evaluation|In all pre-treatment specimens and analysis of post treatment specimens when available.|1 year|Inability for sequencing due to inadequate amount of tissue||||||
1400553|NCT01259063|Secondary|Survival of Patients Treated|With Everolimus in combination with intravesical gemcitabine. Overall survival following start of therapy will be estimated using Kaplan-Meier methods.|1 year||||% of pts with CR who relapsed in a year||95% Confidence Interval|Number
1400554|NCT01259063|Secondary|Complete Response (CR) Rate|Complete Response (CR) is defined as no evidence of disease (by cytology and cystoscopy). Partial Response is defined as negative cystoscopy and positive cytology. Progression is defined as the development of invasion or metastasis. If the participant develops a recurrence, they will be considered having failed treatment. Participants will also be considered having failed treatment if there is no response to treatment after two cycles.|1 year||||Participants|||Count of Participants
1400555|NCT01259063|Primary|Phase I - Maximum Tolerated Dose (MTD)|of Everolimus given in conjunction with intravesical gemcitabine|8 weeks|14 participants enrolled in Phase I|||mg daily of everolimus|||Number
1400556|NCT01259063|Primary|Phase II - Patients Who Are Free of Disease at 1 Year|following start of therapy.|1 year|19 participants were evaluable for Phase II.|||percentage of pts disease free at 1 year||95% Confidence Interval|Number
1400557|NCT01259063|Primary|Phase I - Dose-limiting Toxicity (DLT)|Everolimus (mg) given in conjunction with intravesical gemcitabine|8 weeks|14 of the 33 participants were enrolled in the Phase I portion of the protocol|||DLT|||Number
1400558|NCT01259024|Secondary|To Track Survival Following Treatment With DEB to Confirm That Any Gains in Response Are Associated With an Increase in Survival.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|1 participant was enrolled, analyzed was 0.||||||
1400559|NCT01259024|Primary|Monitor Safety After Treatment of DEB by Measuring Liver Function Tests and Assessing Performance Status.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|||||||
1400560|NCT01259024|Primary|Determine Efficacy (Based on Whether the Study is Positive or Negative) of the Embolization With the LC Bead in Treatment of HCC With Imaging Outcomes Using Modified RECIST and EASL Criteria.|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|1 patient was enrolled in the study, but was withdrawn by the PI due to inability to obtain CMS reimbursement. The patient was treated off protocol and therefore there are no study results to be analyzed.||||||
1400561|NCT01259024|Primary|To Collect Data on Patients With Hepatocellular Carcinoma (HCC) Being Treated With Chemoembolization With Doxorubicin Eluting Beads (DEB).|4-6 weeks after initial treatment, follow-up imaging will be obtained. With positive response to treatment, follow-up imaging will be obtained every 12 weeks. If a new tumor develops or if local progression of the treated malignancy occurs, the patient may be retreated with LC Beads 4-6 weeks after the first treatment with re-imaging 4-6 weeks following each subsequent treatment.|Patients will participate in protocol until date of death, liver transplantation, or withdrawal from study.|One participant was enrolled on this IDE and was treated on protocol for 14 weeks. After being made aware that CMS would not provide reimbursement, the PI decided to withdraw the patient and continued to treat off protocol.||||||
1400562|NCT01259011|Secondary|Change Over Time: Post-traumatic Distress Symptom Score|The Post-Traumatic Symptoms Scale-10 (PTSS-10) was used to assess the presence and intensity of PTSD symptoms during the preceding 7 days. This self-report scale consists of 10 statements that specifically mention symptoms related to PTSD criteria (e.g., sleep problems, nightmares, tension in the body, irritation, startle, etc.) rated on a 7-point Likert scale from 1 (Never/Rare) to 7 (Very often/Always). A total score (range 10 - 70) of > 35 is associated with a high probability that the person meets the diagnostic criteria for PTSD.|2 weeks and 3 and 6 months after patient death||||units on a scale||Standard Deviation|Mean
1400563|NCT01259011|Secondary|Change Over Time: Hospital Anxiety and Depression Scale Scores|Hospital anxiety and depression (HADS) scores range from 0 to 21 with higher scores indicating greater symptom severity.|2 Weeks, and at 3 and 6 months post death||||units on a scale||Standard Deviation|Mean
1400564|NCT01259011|Primary|Dyad Congruence|patient and surrogate congruence on the goals of care|2, 6, 12 months|patients on dialysis and their surrogates|||percentage of congruent dyads|||Number
1400565|NCT01258998|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity data will be summarized by frequency tables. The association between both type and severity of toxicity and the treatment groups will be evaluated.|Up to 30 days|||||||
1400566|NCT01258998|Secondary|Change in Biomarker Levels of Interest (Akt, pAKT, and Apoptosis [Annexin-V])|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment|||||||
1400567|NCT01258998|Secondary|Change in Chemokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment|||||||
1400568|NCT01258998|Secondary|Change in Cytokine Levels|Association between markers and OR using logistic regression models, and the association between markers and time-to-event outcomes using Cox proportional hazards models.|Baseline to up to 30 days post-treatment|||||||
1400569|NCT01258998|Secondary|Overall Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 30 days|||||||
1400570|NCT01258998|Secondary|Duration of Response|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days|||||||
1400571|NCT01258998|Secondary|Progression-free Survival|Will be estimated using the Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days|||||||
1400572|NCT01258998|Primary|Objective Response Rate (ORR)|Objective response rate. Logistic regression utilized to assess the effect of patient demographic factors on OR.|4 months|Based on intent-to-treat analysis.|||participants|||Number
1400573|NCT01258985|Secondary|Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.|From Week 0, to week 24 or to week 52||||units on a scale||95% Confidence Interval|Mean
1400574|NCT01258985|Secondary|Outcome Expectation Scale|The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.|Week 0||||units on a scale||Standard Deviation|Mean
1400575|NCT01258985|Secondary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function|The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
1403104|NCT01236521|Secondary|SF-36 General Health Perception|The SF-36 is a subscale that assesses the self-reported general health. It is scored on a 0 to 100 scale with higher scores representing greater perceived general health|baseline||||scores on a scale||Standard Deviation|Mean
1400576|NCT01258985|Secondary|Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
1400577|NCT01258985|Secondary|Change in Arthritis Self-Efficacy Scale|The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
1400578|NCT01258985|Secondary|Change in Beck II Depression Inventory|Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
1400579|NCT01258985|Secondary|Change in Patient Global VAS|Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
1400580|NCT01258985|Secondary|Change in 20 Meter Walk Test|the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability|From Week 0, to Week 12, or to week 24, or to week 52||||seconds||95% Confidence Interval|Mean
1400581|NCT01258985|Secondary|Change in 6 Minute Walk|The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.|From Week 0, to Week 12, or to week 24, or to week 52||||meters||95% Confidence Interval|Mean
1400582|NCT01258985|Secondary|Change in Medical Outcomes Short Form-36 PCS|The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)|From Week 0, to Week 12, or to week 24, or to week 52||||units on a scale||95% Confidence Interval|Mean
1400583|NCT01258985|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks|The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0–500), stiffness (0–200), and function (0–1700), with higher scores indicating more severe disease.|From Week 0 to Week 12||||units on a scale||95% Confidence Interval|Mean
1400584|NCT01258803|Secondary|Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose FVC measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1400585|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1400586|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1400587|NCT01258803|Secondary|AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1403135|NCT01236339|Secondary|Frequency of Paracentesis|Number of paracentesis post randomization|Through 24 months||||Number of episodes|||Number
1400588|NCT01258803|Secondary|Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose|Baseline was defined as the average of 2 predose measurements (taken 30 minutes and immediately before dosing).|Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1400589|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1400590|NCT01258803|Secondary|AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1400591|NCT01258803|Primary|Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer|The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.|Up to 12 hours postdose|Participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment|||Liters||Standard Error|Least Squares Mean
1400592|NCT01258790|Primary|Yale Global Tic Severity Scale|The tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.|1 week||||units on a scale (0 - 50)||Standard Deviation|Mean
1400593|NCT01258738|Secondary|Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points|PASS is defined as a symptom state that the participants consider acceptable.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400594|NCT01258738|Secondary|Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points|The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are “Improved - less pain”, “No change”, and “Worse – more pain.” If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from “Not at all important” to “Very important’.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400595|NCT01258738|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104|The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400646|NCT01258738|Secondary|Mean Change From Baseline in BASFI Full Day Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400596|NCT01258738|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points|"The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, I tire easily) are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, I feel fit) a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by “Yes, that is true” (scored 1) to “No, that is not true” (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400597|NCT01258738|Secondary|Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent overall work impairment due to health problem:~Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400598|NCT01258738|Secondary|Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400599|NCT01258738|Secondary|Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400600|NCT01258738|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points|"The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated:~Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity."|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400601|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points|The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual’s ability levels given their AS and their job. Each question is assigned a score of 1 for a response of “True” and 0 for a response of “Not True”. All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400628|NCT01258738|Secondary|Percentage of Participants With BASDAI 20 at Time Points|Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400602|NCT01258738|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400603|NCT01258738|Secondary|Change From Baseline in HADS Anxiety Score at Time Points|This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400604|NCT01258738|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points|This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400605|NCT01258738|Secondary|Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400606|NCT01258738|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400607|NCT01258738|Secondary|Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||Units on a scale||Standard Error|Mean
1400608|NCT01258738|Secondary|Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||mm||Standard Error|Mean
1400609|NCT01258738|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||mm/hr||Standard Error|Mean
1400610|NCT01258738|Secondary|Change From Baseline in C-reactive Protein (CRP) Concentration Time Points|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||mg/L||Standard Error|Mean
1400675|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Systolic Volume (ESV)|"ESV is the volume of blood remaining in each ventricle at the end of systole.¹~¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population|||Milliliter(s)||Standard Deviation|Mean
1400611|NCT01258738|Secondary|Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400612|NCT01258738|Secondary|Mean Change From Baseline in Dactylitis Score at Time Points|Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400613|NCT01258738|Secondary|Mean Change From Baseline in Number of Tender Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Number of joints||Standard Error|Mean
1400614|NCT01258738|Secondary|Mean Change From Baseline in Number of Swollen Joints at Time Points|Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Number of joints||Standard Error|Mean
1400615|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score|ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases|||Units on a scale||Standard Error|Mean
1400616|NCT01258738|Secondary|Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.|||units on a scale||Standard Error|Mean
1400617|NCT01258738|Secondary|Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points|The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.|Weeks 12 and 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.|||units on a scale||Standard Error|Mean
1400645|NCT01258738|Secondary|Mean Change From Baseline in BASFI Bending Forward at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400618|NCT01258738|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks|The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through observed cases.|||units on a scale||Standard Error|Mean
1400619|NCT01258738|Secondary|Mean Change From Baseline in Occiput-to-wall Test at Time Points|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||cm||Standard Error|Mean
1400620|NCT01258738|Secondary|Change From Baseline in Chest Expansion at Time Points|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||cm||Standard Error|Mean
1400621|NCT01258738|Secondary|Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400622|NCT01258738|Secondary|Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400623|NCT01258738|Secondary|Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400624|NCT01258738|Secondary|Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400625|NCT01258738|Secondary|Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400626|NCT01258738|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400627|NCT01258738|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points|The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400629|NCT01258738|Secondary|Percentage of Participants With BASDAI 50 at Time Points|Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400630|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400631|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400632|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400633|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Discomfort at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400634|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400635|NCT01258738|Secondary|Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400676|NCT01258387|Secondary|Change From Baseline of 2D-ECHO Measured by End-Diastolic Volume (EDV)|"EDV is the amount of blood in the ventricle immediately before a cardiac contraction begins; used as a measurement of diastolic function.¹~¹http://medical-dictionary.thefreedictionary.com/end-diastolic+volume"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population|||Milliliter(s)||Standard Deviation|Mean
1400636|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400637|NCT01258738|Secondary|Mean Change From Baseline in BASFI Putting on Socks at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400638|NCT01258738|Secondary|Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400639|NCT01258738|Secondary|Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400640|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400641|NCT01258738|Secondary|Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400642|NCT01258738|Secondary|Mean Change From Baseline in BASFI Reaching up High at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400643|NCT01258738|Secondary|Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400644|NCT01258738|Secondary|Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400689|NCT01258101|Secondary|Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48|Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Where Baseline (BS) is Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
1400647|NCT01258738|Secondary|Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400648|NCT01258738|Secondary|Changes From Baseline in VAS Score for Total Back Pain at Time Points|The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
1400649|NCT01258738|Secondary|Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points|The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for “No pain ” to 100 mm for “Most Severe Pain.”|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
1400650|NCT01258738|Secondary|Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points|Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
1400651|NCT01258738|Secondary|Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points|The Investigator estimated the participant’s overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach. The values were converted to cm for analysis purposes.|||cm||Standard Error|Mean
1400652|NCT01258738|Secondary|Time to ASAS Partial Remission|The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.|Week 12|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA.|||percentage of participants||95% Confidence Interval|Number
1400653|NCT01258738|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Time Points|Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400654|NCT01258738|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points|ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Units on a scale||Standard Error|Mean
1400655|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 5/6 Response at Time Points|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400656|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 20 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400657|NCT01258738|Secondary|Percentage of Participants Achieving ASAS 40 Response at Time Points|ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Baseline to Week 104|mITT population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for AxSpA. Missing data were imputed through LOCF approach.|||Percentage of participants|||Number
1400658|NCT01258738|Primary|Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 12|Modified intent-to-treat (mITT) population defined as all randomized participants who took at least one dose of study drug, had at least one on-therapy evaluation and met the ASAS classification criteria for axial spondyloarthritis (AxSpA). Missing data were imputed through last observation carried forward (LOCF) approach.|||Percentage of participants|||Number
1400659|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Folic Acid|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with folic acid|baseline, and up to 24 weeks of treatment||||µmol/L||Standard Deviation|Mean
1400660|NCT01258660|Secondary|Homocysteine Concentrations in Plasma at Baseline and at the End of Treatment (Week 24) With Metafolin|Homocysteine concentrations in plasma at baseline (median of baseline concentrations) and at the end of treatment (week 24) with Metafolin|baseline and week 24||||µmol/L||Standard Deviation|Mean
1400661|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 6|Folate metabolite pattern in plasma at cycle 6|week 24||||nmol/L||Standard Deviation|Mean
1400662|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Cycle 3|Folate metabolite pattern in plasma at cycle 3|week 12||||nmol/L||Standard Deviation|Mean
1400663|NCT01258660|Secondary|Folate Metabolite Pattern in Plasma at Baseline|Folate metabolite pattern in plasma at baseline|pre-treatment|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||Standard Deviation|Mean
1400664|NCT01258660|Primary|Proportion of Participants With RBC Folate Below 906 Nmol/L in the Yasmin + Metafolin Group in the Folate Elimination Phase (Week 24 to 44)|Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)|from week 24 to week 44||||proportion of participants|||Number
1400665|NCT01258660|Primary|Area Under the Curve From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Corrected)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment||||nmol·week/L||95% Confidence Interval|Geometric Mean
1400666|NCT01258660|Primary|Area Under the Curve (AUC) From Time 0 to 24 Weeks [AUC(0-24weeks)] for Plasma Folate and RBC (Red Blood Cell) Folate (Baseline Uncorrected)|The Area under the curve (AUC) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 24 weeks of treatment||||nmol·week/L||95% Confidence Interval|Geometric Mean
1400667|NCT01258595|Secondary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Solicited Injection Site Reactions: Pain, Erythema, Swelling, Ecchymosis, and Induration. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, safety analysis set population.|||Participants|||Number
1400668|NCT01258595|Primary|Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Seroprotection was defined as a titer ≥ 40 (1/dilution [1/dil]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post vaccination|Seroprotection was assessed in the full analysis set population.|||Percentage of Participants|||Number
1400669|NCT01258595|Primary|Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|"Seroconversion: For participants with a Day 0 (pre-vaccination) titer < 10 (1/dilution [1/dil]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28.~Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method."|Day 0 and Day 28 post-vaccination|Seroconversion to the vaccine antigens was assessed in the full analysis set population.|||Percentage of Participants|||Number
1400670|NCT01258595|Primary|Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 Post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
1400671|NCT01258595|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.|Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.|Day 0 and Day 28 post-vaccination|Serum antibody titers to vaccine antigens were assessed in the full analysis set population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
1400672|NCT01258582|Primary|Acceptability of the HIV Test|The primary outcome measure was HIV test acceptance rate defined by the proportion of participants whom accepted HIV testing among those randomized within each trial arm (fingerstick or oral fluid).|Assess on day subject enrolled into the study|Intent to treat analysis|||proportion of participants||95% Confidence Interval|Number
1400673|NCT01258504|Primary|Cmax of Bosentan||after first dose, at steady-state and during SJW||||ng/ml||95% Confidence Interval|Geometric Mean
1400674|NCT01258504|Primary|AUC of Bosentan||0-infinity; during dosing interval||||h*ng/ml||95% Confidence Interval|Geometric Mean
1400677|NCT01258387|Secondary|Change From Baseline of Two-Dimensional Echocardiogram (2D-ECHO) Measured by Ejection Fraction (EF)|"An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.¹~Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts.²~¹http://wakeinternalmedicine.com/services-and-procedures/services/radiology/2d-echo/~²http://www.mayoclinic.org/ejection-fraction/expert-answers/faq-20058286"|Screening, day 8, day 14, day 28, and 3 months post-dose|Safety Population|||percent change||Standard Deviation|Mean
1400678|NCT01258387|Primary|Safety of Single Ascending Doses of GGF2 Via an Assessment of the Toxicology Profile as Measured by Treatment Emergent Adverse Events (TEAEs)|"Safety/ tolerability of single dose; cumulative safety over 6 months~TEAEs are defined as adverse events with date of onset (or worsening) on or after the start date of double-blind treatment and no more than 28 days from the start date of double-blind treatment."|6 months|Safety population|||participants|||Number
1400679|NCT01258153|Secondary|Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test.|Safety and tolerability will be assessed for the Safety Population (all patients who received the study drug) in terms of frequency and severity of AEs as well as frequency of clinically significant changes in physical examination and lab test.|up to four weeks|All patients receiving the study drug (114)|||Adverse events|||Number
1400680|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|10 days|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment|||Score range 0-5|Participants|Standard Deviation|Mean
1400681|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|1 week|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment|||Score range 0-5|Participants|Standard Deviation|Mean
1400682|NCT01258153|Secondary|Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline|"On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for Not at all and 5 is Extremely.~The question was How frustrating to you was your baby's crying today?)"|1 day|ITT - defined as the safety population randomised with at least 24h diary recording post 1st dose of study treatment|||Score range 0-5|Participants|Standard Deviation|Mean
1400683|NCT01258153|Secondary|Percentage of 'Responder' Babies at the End of Treatment Period.|Response is defined as a decrease of at least 50% of crying and fussing time during the last 3 days on treatment vs baseline.|baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured|||Responders Rate (% of responders babies)|||Number
1400684|NCT01258153|Primary|Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.|Efficacy assessment to be measured through “baby’s day” diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration).|Baseline and one week|112 instead of 113, because 1 subject had no records at baseline and therefore the outcome could not be measured|||Minutes||Standard Deviation|Mean
1400685|NCT01258101|Secondary|Time to Viral Response|Time to viral response was calculated as Date of first negative PCR result after screening – date of PCR screening sample + 1 [in days]. Mean of number of days to viral response for overall population were reported.|Up to Week 48|Standard analysis population includes all randomized participants.|||Days||Standard Deviation|Mean
1400686|NCT01258101|Secondary|Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48|For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated. BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression. Mean scores are presented by visit. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
1400687|NCT01258101|Secondary|Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48|Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires. BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status. The BL questionnaire items were scored by calculating the average response to all answered items. Items were graded 1=”stark” (affliction is strong) to 4=”gar nicht” (not present). The higher the BL score, the less afflictions were present for a participant. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
1400688|NCT01258101|Secondary|Mean FSS Scores at Baseline and Weeks 16, 24 and 48|The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The participants were asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue. Baseline is defined as Week 0.|At Baseline (Week 0) and Weeks 16, 24 and 48|Standard analysis population includes all randomized participants.|||Score on a scale||Standard Deviation|Mean
1400706|NCT01258049|Secondary|PRR 12 [MITT Population]|The percentage reduction in parasite counts 12 hours after first dose|28 days after start of treatment||||percentage of baseline||Standard Deviation|Mean
1400690|NCT01258101|Secondary|Median Hemoglobin Levels at End of Treatment|Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported. The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L). The far most frequent hemoglobin class was >=100 g/L. The purpose of assessing the Hb levels is associated with ribavirin dose. The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy. Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.|At Week 16 and Week 24|The Safety analysis population was defined to include only participant who received at least one dose of (either) study medication and had at least one post-baseline safety assessment.|||g/L||Inter-Quartile Range|Median
1400691|NCT01258101|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|The Safety analysis population was defined to include only participants who received at least one dose of (either) study medication and had at least one post-baseline assessment.|||Number of Participants|||Number
1400692|NCT01258101|Secondary|Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment|Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24. Virologic response rates based on genotype (G2 and G3) were reported. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1400693|NCT01258101|Secondary|Percentage of Participants With Virological Response at the End of the Treatment|Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment. ETR is defined as Week 16 and Week 24.|At Week 16 and Week 24|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1400694|NCT01258101|Primary|Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48|Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.|At Week 24 and Week 48|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1400695|NCT01258101|Primary|Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment|Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.|Up to Week 48 (24 weeks post completion of the treatment)|Standard analysis population includes all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1400696|NCT01258049|Secondary|Number of Deaths or Neurological Sequelae at Day 28||28 days after start of treatment||||participants|||Number
1400697|NCT01258049|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities||28 days after start of treatment||||participants|||Number
1400698|NCT01258049|Secondary|Time to Return to Normal Per os Status|Time in hours to return to normal per os status. Normal per os was when the investigator considered the patient to be able to eat and drink normally.|28 days after start of treatment||||hours||Standard Deviation|Mean
1400699|NCT01258049|Secondary|Time to Return to Full Consciousness|"Time in hours to return to full consciousness (Blantyre Coma Scale = 5), if level of consciousness is reduced (Blantyre Coma Scale <5) prior to dosing or within 24hours of first dosing.~For the Blantyre Coma Scale~Total - maximum 5, eye movement - maximum 1, best motor response - maximum 2, best verbal response - maximum 2"|28 days after start of treatment||||hours||Standard Deviation|Mean
1400700|NCT01258049|Secondary|Late Parasitological Failure|o Parasitaemia on any day from Day 7 to Day 28 and tympanic temperature ≤ 38.0°C|28 days after the start of treatment||||participants|||Number
1400701|NCT01258049|Primary|Parasitological Success (PP)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|The Per Protocol (PP) population included the subjects in the MITT population who had received at least 80% of doses up to the time of discharge from the hospital, had evaluable data up to and including Day 28 and had no major protocol violations.|||participants|||Number
1400702|NCT01258049|Secondary|Late Clinical Failure|"Signs of severe malaria on any day between Day 4 and Day 28 in the presence of parasitaemia, without previously meeting any of the criteria of early treatment failure~Presence of parasitaemia and tympanic temperature ≥ 38.0°C (or history of fever), on any day between Day 4 and Day 28, without previously meeting any of the criteria of early treatment failure"|28 days after the start of treatment||||participants|||Number
1400703|NCT01258049|Secondary|Early Treatment Failure|"Early treatment failure is indicated by one or more of the following:~Parasite count on Day 2 > Day 0, irrespective of temperature~Parasite count on Day 3 > 0 with tympanic temperature ≥ 38.0°C~Parasite count on Day 3 ≥ 25% of baseline~Administration of rescue antimalarial treatment"|Three days after the start of treatment||||participants|||Number
1400704|NCT01258049|Secondary|Complete Cure Rate|The complete resolution of clinical signs and symptoms, malaria-related laboratory abnormalities, and elimination of asexual parasites by Day 7, with no recurrence up to Day 28 (+/- 2 days), and the 48h parasite count to be < 25% of baseline with no clinical deterioration|28 days after the start of treatment|For some subjects, this endpoint was not evaluable and/or not all data was received.|||participants|||Number
1400705|NCT01258049|Secondary|Fever Clearance Time (FCT)|Time in hours from the initiation of therapy until the disappearance of fever (tympanic temperature < 38.0) that lasted at least 24 hours.|28 days after start of treatment||||hours||Standard Deviation|Mean
1400711|NCT01258049|Primary|Parasitological Success (MITT)|Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose|24 hours after start of treatment|"The Modified Intention to Treat (MITT) population included all randomised subjects who received at least one dose of study medication and had evaluable parasite counts at 24 hours after first dosing.~7 subjects for ArTiMist and 3 subjects for quinine were excluded due to no baseline or 24 h parasite count"|||participants|||Number
1400712|NCT01257880|Secondary|White Matter Lesions|Presence and severity of white matter lesions on magnetic resonance imaging, taken within 5 years prior to study enrollment. Subjects will not have magnetic resonance imaging performed as part of this study. Films will be requested and an independent neuroradiologist will assess presence of white matter lesions.|Within 5 years prior to enrollment|||||||
1400713|NCT01257880|Secondary|Oxygen Desaturation Index|Measurement of number of times per hour blood oxygen saturation decreases by at least 4% during home sleep study.|Baseline|||||||
1400714|NCT01257880|Primary|Cognitive Function|Cognitive function will be assessed by a battery of performance-based neuropsychological tests.|Baseline|||||||
1400715|NCT01257880|Primary|Sleep Apnea, Number of Participants|An apnea-hypopnea index (AHI) >10 per hour during a home sleep study, defined as at least 5 hours of recorded data on the portable sleep monitor instrument for either the apnea-hypopnea index (AHI) or oxygen desaturation index (ODI) and at least 3 hours for the other index. The scale adopted for assessment of sleep apnea is as follows: AHI < 5, optimal; AHI 5-10, equivocal, participant may have sleep apnea; AHI >10, sleep apnea highly likely.|Following one night of a home sleep study|The analysis was based on per protocol.|||participants|||Number
1400716|NCT01257880|Primary|Platelet Activation|Platelet-poor plasma levels of sCD40L and P-selectin, and serum concentration of TXB2.|Baseline|||||||
1400717|NCT01257880|Primary|Cerebral Vasomotor Reactivity (VMR)|"The percentage change in basilar artery blood flow velocity from baseline between hypercapnia (increased blood CO2) and hypocapnia (decreased blood CO2), as measured by transcranial Doppler during a single testing period. This is calculated using the following equation:~VMR = 100 x (VelocityHYPERCAPNIA - VelocityHYPOCAPNIA) / VelocityBASELINE"|Baseline||||Percentage change||Standard Deviation|Mean
1400718|NCT01257880|Primary|Embolic Tracks|Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver|Baseline|||||||
1400719|NCT01257802|Secondary|Mean Ovarian Volume.|Mean ovarian volume reflects the preservation of ovarian tissue despite exposure to cyclophosphamide; reduced ovarian size is documented in cyclophosphamide treated patients|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone|||cubic centimeters||Standard Deviation|Mean
1400720|NCT01257802|Secondary|Mean Antral Follicle Count (AFC)|Mean antral follicle count (AFC) is the average number of follicles counted in each of 2 ovaries|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study before reaching the 24 week (6 month) milestone, and 2 subjects of the 6 subjects receiving active drug did not have ultrasound performed at the 24 week (6 month) milestone|||# of ovarian follicles||Standard Deviation|Mean
1400721|NCT01257802|Secondary|Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.|An AMH level of >1 ng/ml and/or an antral follicle count of >4 in either ovary is a strong predictor of residual ovarian function|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone|||Participants|||Count of Participants
1400722|NCT01257802|Secondary|Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,|AMH level ≤1.0 predicts onset of menopause within 5 years in normal women|baseline and 6 months|4 of the 7 subjects in the placebo arm dropped out of the study and 2 of the remaining subjects failed to have blood drawn at the 24 week (6 month) milestone, and 1 subject of the 6 subjects receiving active drug dropped out of the study before reaching the 24 week (6 month) milestone|||Participants|||Count of Participants
1400723|NCT01257802|Primary|Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit|AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.|Day 0 to 6-month post-intervention visit|8 subjects are listed in the breakdown of baseline characteristics. Samples were missing from one subject enrolled in the Placebo arm - therefore analysis throughout the majority of the reporting will include only 7 samples instead of 8 in the Placebo arm|||ng/ml||Standard Deviation|Mean
1400724|NCT01257750|Secondary|Corneal Vessel Caliber|Corneal vessel caliber is the measurement of the diameter of the corneal blood vessels. The mean change in the corneal vessel caliber from baseline to 12 week time point is reported below.|12 Weeks||||millimeters||Standard Deviation|Mean
1400725|NCT01257750|Secondary|Corneal Vessel Length|Corneal vessel length is the measurement of the length of the extent of vessels from end to end. The mean change in corneal vessel length from Baseline to 12 Week Time Point is reported below.|12 Weeks||||millimeters||Standard Deviation|Mean
1400726|NCT01257750|Secondary|Corneal Invasion Area|Corneal Invasion area is the measurement of the fraction of the total corneal area that is invaded by blood vessels. The mean Change in Corneal invasion area from baseline to 12 Week Time Point is reported below.|12 Weeks||||millimeters squared||Standard Deviation|Mean
1400727|NCT01257750|Secondary|Corneal Neovascular Area|Corneal neovascular area is the measurement of the area of the cornea where new blood vessels are forming. The mean Change in Corneal Neovascular Area from Baseline to 12 Week Time Point is reported below.|Through 12 weeks of Follow-Up|Mean Change in Corneal Neovascular Area (measuring the area of the corneal vessels) from Baseline to 12 Week Time Point.|||millimeters squared||Standard Deviation|Mean
1400728|NCT01257750|Primary|Intaocular Pressure|Intaocular pressure is the measurement of pressure within the eye. Intaocular pressure was measured throughout the study to assess subjects for ocular adverse events.|12 Weeks||||mmHg||Standard Deviation|Mean
1403386|NCT01235338|Secondary|Systolic Blood Pressure||Baseline and up to 39 days|Safety Analysis Set (SAS) defined as all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1400732|NCT01257737|Secondary|Mean California Verbal Learning Test Scores: Short and Long Delay Free Recall, Short and Long Delay Cued Recall, CVLT-II-Learning Slope, and Total Word Recognition Discrimination|The California Verbal Learning Test – Second Edition (CVLT-II) assesses recall and recognition of word lists over several immediate- and delayed-memory trials. In the learning phase, adult participants were presented a list of 16 words (List A; 4 words each in 4 categories [e.g., fruit, toys, etc.]) for 5 trials, but words from the same category were never presented consecutively. An interference list (List B) of 16 different words was then presented for 1 trial. Short-and long-delay recalls for List A, yes/no recognition trials of List A, and a forced-choice recognition trial of List A was also administered. The scores for the learning slope, the short- and long-delay scores and total word recognition discrimination scores were converted to Z-scores by computer software. The CVLT-II Z-score has a mean of 0 and a standard deviation of 1. Negative scores indicate below-average performance.|Baseline, Month 12, Month 24, Month 36, Month 48, and study exit visit (up to 66 months)|Adult participants (age 19-61) with available data; data were not analyzed for the 4 ongoing adult participants in Canada after the cutoff for the clinical study report (29 Oct 2015).|||Z-Score||Standard Deviation|Mean
1400733|NCT01257737|Secondary|Mean California Verbal Learning Test Scores: List A Total 1-5 T-Scores|The California Verbal Learning Test – Second Edition (CVLT-II) assesses recall and recognition of word lists over several immediate- and delayed-memory trials. In the learning phase, adult participants were presented a list of 16 words (List A; 4 words each in 4 categories [e.g., fruit, toys, etc.]) for 5 trials, but words from the same category were never presented consecutively. An interference list (List B) of 16 different words was then presented for 1 trial. Short-and long-delay recalls for List A, yes/no recognition trials of List A, and a forced-choice recognition trial of List A was also administered. The total score for the 5 immediate-recall trials was converted to a T-score. Lower T-scores reflect worse performance.|Baseline, Month 12, Month 24, Month 36, Month 48, and study exit visit (up to 66 months)|Adult participants (age 19-61) with available data; data were not analyzed for the 4 ongoing adult participants in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-Score||Standard Deviation|Mean
1400734|NCT01257737|Secondary|Mean Behavior Rating Inventory of Executive Function (BRIEF) Scores|The Behavior Rating Inventory of Executive Function (BRIEF) is designed to assess executive functioning in children and adolescents ages 5 to 18 years of age. Parents/caregivers answered 86 questions on a 3-point scale (never, sometimes, often). Similar questions were grouped together into 8 scales; these scales were summed to produce 2 index measures and a global executive composite score. Raw scores for the indices/scales and composite score were converted to T-scores with corresponding 90% confidence intervals using computer software. Higher T-scores indicate a higher level of dysfunction.|Baseline, Month 12, Month 24, and study exit visit (up to 66 months)|Participants 5-18 years of age with available data; data were not analyzed for the 1 ongoing pediatric participant in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-Score||Standard Deviation|Mean
1400735|NCT01257737|Secondary|Mean Child Behavior Checklist (CBCL) Problems Scores|The Child Behavior Checklist (CBCL) is a widely-used method of identifying problem behavior. Two versions of the CBCL were used in this study; the assessment for children 6-18 years of age was used for participants ≥6 years of age, and the assessment for children 1.5-5 years of age was used for those who were at least 5 years old but <6 years of age. Parents/caregivers answered questions (120 and 100 questions, respectively, for the older and younger populations) using a 3-point Likert scale (0= not true; 1= somewhat or sometimes true; 2 =very true or often true). Using a computer program, responses to similar questions were grouped together into 20 domains (e.g., activities, social, school, etc.), and domain response scores were converted to T-scores and percentiles. A mean score of 50 is average, with a standard deviation of 10 points. Higher scores indicate greater problems. The total problems score is the sum of all of the problem items.|Baseline, Month 12, Month 24, and study exit visit (up to 66 months)|Participants 5-18 years of age with available data; data were not analyzed for the 1 ongoing pediatric participant in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-Score||Standard Deviation|Mean
1400736|NCT01257737|Secondary|Mean Wechsler Abbreviated Scale of Intelligence (WASI) Scores|The Wechsler Abbreviated Scale of Intelligence (WASI) was administered to adults and pediatric participants who were at least 6 years of age. It was used to estimate general intellectual ability (IQ) based on the vocabulary and matrix reasoning subtests. The vocabulary subtest included 4 images and 38 verbal items. In the matrix reasoning subtest, the participant viewed 35 incomplete grid patterns and was asked to complete the pattern using responses from 5 possible choices. The number of correct responses for each of the subtests was converted to a T-score using the WASI assessment manual; T-scores are standard scores with a mean of 50 and a standard deviation (SD) of 10. Raw scores for the 2 subtests were summed, and converted to a standard score (mean of 100 with SD of 15) for the general IQ score for adults and to a T-score for children in accordance with the WASI manual. Higher scores indicate a higher level of intelligence.|Baseline, Month 12, Month 24, Month 36, Month 48, and study exit visit (up to 66 months)|Participants ≥ 6 years of age with available data; data were not analyzed for the 5 ongoing participants in Canada after the cutoff for the clinical study report (29 Oct 2015).|||T-score||Standard Deviation|Mean
1400737|NCT01257737|Secondary|Causes of Hyperammonemic Crises|An hyperammonemic crisis (HAC) was defined as clinical symptoms associated with a venous ammonia concentration of ≥100 μmol/L. Peak observed ammonia concentrations during an HAC, precipitating factors, and symptoms recorded as suggestive to hyperammonemia were documented. There can be multiple contributing factors to an hyperammonemic crisis; in some cases several causes were identified.|From the time of informed consent until 7 days after the last dose of study drug, up to 66 months|Participants who experienced hyperammonemic crises|||Number of crises|Hyperammonemic crises||Number
1400738|NCT01257737|Secondary|Number of Hyperammonemic Crises|An hyperammonemic crisis (HAC) was defined as clinical symptoms associated with a venous ammonia concentration of ≥100 μmol/L.|From the time of informed consent until 7 days after the last dose of study drug, up to 66 months|Safety Population: All participants who received any amount of study medication|||Number of crises|||Number
1400946|NCT01256008|Primary|Hamilton Depression Rating Scale (HAMD-17)|"The scale(HAMD-17) is used to assessed the depression symptoms of patients.~The scale range is 0-53.Higher value represents a worse outcome.~The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week"|baseline,2 w,4 w,8 w,12 w,16 w,24 w||||units on a scale||Standard Deviation|Mean
1400739|NCT01257737|Secondary|Mean Normalized Blood Ammonia Levels|Blood samples were collected for the assessment of plasma ammonia concentrations at baseline, at least every 6 months, at all unscheduled visits, and at the end of study participation. Ammonia level data were obtained from different local laboratories and each laboratory may have used a slightly different normal reference range. Therefore, the ammonia level data were normalized to a standard laboratory reference range before performing any analysis of ammonia data.|From baseline through the end of the study, up to 66 months|Participants with available data|||μmol/L||Standard Deviation|Mean
1400740|NCT01257737|Primary|Number of Participants With at Least One Adverse Event|Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). An AE/adverse experience was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. For additional information regarding adverse events, please see the safety section of the record.|From the time of informed consent until 7 days after the last dose of study drug, up to 66 months|Safety Population: All participants who received any amount of study medication|||Participants|||Count of Participants
1400741|NCT01257581|Secondary|ATLIS Upper Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percentages of predicted normal strength||95% Confidence Interval|Mean
1400742|NCT01257581|Secondary|Accurate Test of Limb Isometric Strength (ATLIS) Lower Percentage of Predicted Normal (PPN)|The ATLIS PPN measures are percentages of predicted normal strength based on age, gender, height, and weight using normative data.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percentages of predicted normal strength||95% Confidence Interval|Mean
1400743|NCT01257581|Secondary|HHD Upper % Baseline|The HHD % baseline measures are mean percent change for shoulder flexion, elbow extension, elbow flexion, wrist extension, and first dorsal interosseous muscles from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percent change||95% Confidence Interval|Mean
1400744|NCT01257581|Secondary|HHD Upper Z-score|The HHD upper z-scores are means of z-scores for right and left shoulder flexion, elbow extension, elbow flexion, write extension and first dorsal interosseous muscles with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Z-score||95% Confidence Interval|Mean
1400745|NCT01257581|Secondary|HHD Lower % Baseline|HHD % baseline measures are mean percent change for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion from each participant's baseline.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||percent change||95% Confidence Interval|Mean
1400746|NCT01257581|Secondary|Hand Held Dynamometry (HHD) Lower Z-score|The HHD lower z-scores are means of z-scores for right and left knee extension, knee flexion, hip flexion, and ankle dorsiflexion with z-scores calculated relative to the baseline mean and standard deviation strength of each muscle group across all participants.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Z-score||95% Confidence Interval|Mean
1400747|NCT01257581|Secondary|Lab Abnormal Reports by Treatment Assignment|The safety data is summarized according to treatment arm. Total number of Adverse Events (AEs), AEs that cause study drug withdrawal and abnormal laboratory tests are compared among treatment arms. A lab abnormality was a result that was out of range and considered clinically significant by the site investigator.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Events|||Number
1400748|NCT01257581|Secondary|Dose Adjustments|These events were due to a double-blinded study design.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Number of Events due to Adverse Events|||Number
1400749|NCT01257581|Secondary|Tracheostomy-free Survival|Secondary efficacy will be assessed by analyzing rate of tracheostomy-free survival at nine months.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||proportion of participants||95% Confidence Interval|Number
1400750|NCT01257581|Secondary|Vital Capacity/Pulmonary Function Testing|Secondary efficacy will be assessed by analyzing the change in the Slow Vital Capacity score over nine months. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percentage of predicted normal.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||Percentage of predicted max value||95% Confidence Interval|Mean
1400751|NCT01257581|Primary|Change in ALS Functional Rating Scale - Revised (ALSFRS-R)|Primary efficacy will be assessed by analyzing the mean rate of decline in the ALS Functional Rating Scale-Revised (ALSFRS-R) score over nine months. The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|38 weeks of treatment followed by a telephone interview at 42 weeks.||||scores on a scale||95% Confidence Interval|Mean
1400752|NCT01257542|Secondary|Participants' Global Assessment of Cough: Relief From Cough|Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question “From when you woke up this morning until now, how much better is your cough?” where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
1400753|NCT01257542|Secondary|Participants' Global Assessment of Cough: Cough Severity|"Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question  How much have you coughed in the past 6 hours?” where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot."|Within 5 minutes after Hour 6|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
1400947|NCT01255904|Primary|Time to Complete Study|Time from medication administration to study completion.|60-180 minutes||||Minutes||95% Confidence Interval|Median
1400754|NCT01257542|Secondary|Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
1400755|NCT01257542|Secondary|Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period|Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hour post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
1400756|NCT01257542|Secondary|Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6|Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
1400757|NCT01257542|Secondary|Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period|Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question “How much have you coughed in the last hour?”, where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.|Baseline, 1, 2, 3, 4, 5, 6 hours post-dose|ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Units on a scale||Standard Deviation|Mean
1400758|NCT01257542|Primary|Total Cough Count|Total cough count was done by trained assessors using continuous digital video and audio recordings.|Up to 6 hours post-dose|Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.|||Cough counts||Standard Deviation|Mean
1400759|NCT01257503|Secondary|Overall Symptom Severity|Change in cold symptoms of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents assessed severity of runny nose, cough, sneeze and congestion in their child using a 0-3 scale for each symptom, 0=none to 3= severe. Cold score is sum of scores for each symptom. Parents assessed cold score twice daily on study days 1-3 and at the 7-10 day follow-up|10 days|Data analyzed on participant who completed 7-10 day follow-up and had valid cold scores. Data also analyzed twice daily on those participants who returned symptom diaries including: day 1 (153, 148), day 2 (146,138), and day 3 (136, 126). For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale||Standard Deviation|Mean
1400760|NCT01257503|Secondary|Health Status|Change in health status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated health status on 1-10 scale with 1 indicating perfect health and 10 indicating very sick. Health status rated on first 3 days of study and again at the 7-10 day follow-up|10 days|Health status on those with follow-up data and a valid score for health status. Health status also assessed in participants who returned symptom diaries including 152 on day 1, 142 on day 2 and 132 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale||Standard Deviation|Mean
1400761|NCT01257503|Secondary|Functional Status|Change in functional status of child during the 7-10 days after the index visit for an upper respiratory tract infection. Parents rated 5 activities (vigorous activity, activities that require concentration, activities with family or friends, appetite and sleep) daily for 3 days in their child and again at the 7-10 day follow-up. Functional status scores range from 0 to 15, with higher scores indicative of better functional status.|10 days|Participants who completed follow-up and had valid data for functional outcome. Data on functional status analyzed on days 1-3 for participants who returned symptom diaries including 145 on day 1, 142 on day 2 and 130 on day 3. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale||Standard Deviation|Mean
1400762|NCT01257503|Secondary|Change in Non-specific Symptoms|Parents measured change in severity of irritability, lethargy, fussiness, and appetite one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in irritability assessed after 510 doses, lethargy 414, fussiness 501, appetite 618. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale|Participants|Standard Deviation|Mean
1400787|NCT01257230|Secondary|FEF25-75 Change From Baseline|"Change from baseline in mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75%), also known as maximum mid-expiratory flow, at individual time points after 24 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres per second||Standard Error|Mean
1400763|NCT01257503|Primary|Change in Severity of Cold Symptoms|Parents measured change in runny nose, cough, nasal congestion and sneezing severity one hour after administering a dose of study medication up to the first 10 doses of study medication. Change in symptom rated from 0 to 6, with 0 indicative of the symptom being much worse and 6 indicative of the symptom being much improved. The unit of analysis for each outcome was doses of medication. Each participant could contribute data on 0 - 10 doses.|Parents assessed change in symptom 1 hour after a dose of study medication|Data are from logbooks returned by participants. For each participant, data on response to up to 10 doses were collected. Not every symptom was present at each dose. Change in runny nose assessed after 819 doses, sneeze 456 doses, cough 772 doses, congestion 845. For category title, first n= homeopathic cold remedy, second n= placebo.|||units on a scale|Participants|Standard Deviation|Mean
1400764|NCT01257438|Secondary|Percentage of Participants With Primary Lesion Patency (PLP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through Six Months in the Treatment of In-stent Restenotic Lesions.|Primary Lesion Patency (PLP) is defined as the interval after the index intervention until the next re-intervention at the original treatment site or until the extremity is abandoned for permanent access. Freedom from re-intervention is the criteria for success.|6 months||||% of subjects with successful PLP||95% Confidence Interval|Number
1400765|NCT01257438|Primary|Non-inferiority of FLUENCY® PLUS Endovascular Stent Graft (Following PTA) Over PTA Alone Through 30 Days in the Treatment of In-stent Restenotic Lesions.|Safety rates measured for the randomized subjects population (both Arteriovenous (AV) Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.|30 days|Safety rates measured for the randomized subjects population (both AV Graft and Fistula subjects combined), the percentage of subjects free from safety events through 30 days.|||% of subjects free from safety events||95% Confidence Interval|Number
1400766|NCT01257438|Primary|Percentage of Participants With Access Circuit Primary Patency (ACPP) That is Superior for FLUENCY® PLUS Endovascular Stent Graft (Following Percutaneous Transluminal Angioplasty (PTA)) Over PTA Alone Through Six Months.|Access Circuit Primary Patency (ACPP) is defined as the interval following the index intervention until the next access thrombosis or repeated intervention. ACPP ends with a reintervention anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction. Venous rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis. Freedom from access thrombosis or repeated intervention is the criteria for success.|6 months|Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).|||% of subjects with successful ACPP||95% Confidence Interval|Number
1400767|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||days||95% Confidence Interval|Median
1400768|NCT01257425|Secondary|Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL|tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.|12 weeks|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||days||95% Confidence Interval|Median
1400769|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||log(ng/mL)||Standard Deviation|Mean
1400770|NCT01257425|Secondary|Maximum Concentration of Serum Testosterone [Cmax] - Raw Data|Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose|Analysed for intent-to-treat (ITT) population comprised of 103 patients (IM: 51 and SC: 52 patients).|||ng/mL||Standard Deviation|Mean
1400771|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|85, 87, 113, 141 and 169 days post-dose|95 patients (IM: 47 patients, SC: 48 patients) received a second injection of the study drug.|||log(ng*day/mL)||Standard Deviation|Mean
1400772|NCT01257425|Secondary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)|Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose||||log(ng*day/mL)||Standard Deviation|Mean
1400773|NCT01257425|Primary|Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).|Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.|1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose|Analysed from ITT population.|||log(ng*day/mL)||Standard Deviation|Mean
1400920|NCT01256177|Secondary|Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation|MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114)|||Scores on a scale||Standard Error|Least Squares Mean
1400774|NCT01257347|Secondary|Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period|This will be determined by abstracting data from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider simplified the regimen by switching from a short-acting, multi-day dosing medication to a long-acting, once per day medication or switched two medication to a single combination pill. All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.|1 month clinic visit|patient-provider visits|||percentage of patient-clinician visits|||Number
1400775|NCT01257347|Secondary|Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period|This will be determined based on interviewing patients immediately after the 1-month visit using a standardized questionnaire. A research assistant who is blinded to group assignment will ask patients questions that assess whether clinicians counseled them about taking their blood pressure medications during that most recent visit. These questions are adapted from a validated questionnaire that assesses provider communication about blood pressure medications.|1 month clinic visit||||percentage of patient-clinician visits|||Number
1400776|NCT01257347|Secondary|Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only|This will be determined based on abstracting information from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider intensified the blood pressure regimen (added or increased dose of medications). All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.|1 month clinic visit||||percentage of patient-clinician visits|||Number
1400777|NCT01257347|Primary|Percentage of Visits With Appropriate Hypertension Management|This is assessed using an algorithm in which patients are categorized as adherent or non-adherent based on electronic monitoring. If patients are adherent (summary measure of adherence to blood pressure medications in the week prior to visit is ≥ 80%), then hypertension management is appropriate if clinicians intensify the hypertension regimen or order testing for secondary hypertension. If patients are non-adherent (summary measure of adherence < 80%), then hypertension management is appropriate if clinicians take action to increase adherence through counseling or regimen simplification.|1 month clinic visit||||percentage of patient-clinician visits|||Number
1400778|NCT01257230|Secondary|Time to First Asthma Exacerbation During the 48 Week Treatment Period|The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.|Week 48|FAS|||Participants|||Number
1400779|NCT01257230|Secondary|Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period|The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values. A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required treatment with systemic corticosteroid for at least 3 days.|48 weeks|FAS|||Participants|||Number
1400780|NCT01257230|Secondary|ACQ6 Responders|"Responder rates based on the ACQ6 after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)~The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS|||percentage of participants|||Number
1400781|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ6|"Change from baseline in AQC6 score at week 24.~The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||units on a scale||Standard Error|Mean
1400782|NCT01257230|Secondary|ACQ Total Score Responders|"Responder rates based on the ACQ total score after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Week 24|FAS|||percentage of participants|||Number
1400783|NCT01257230|Secondary|Control of Asthma as Assessed by ACQ Total Score|"Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 24.~The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score was calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||Units on a scale||Standard Error|Mean
1400784|NCT01257230|Secondary|Use of PRN Rescue Medication During the Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||Number of puffs of rescue medication||Standard Error|Mean
1400785|NCT01257230|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and week 24|FAS|||Number of puffs of rescue medication||Standard Error|Mean
1400786|NCT01257230|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 24.~The measured values presented are actually adjusted means."|Baseline and Week 24|FAS|||Number of puffs of rescue medication||Standard Error|Mean
1401988|NCT01247428|Secondary|Percentage of Participants Experiencing Major Adverse Cardiac Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q-wave and non-Q-wave) and target vessel revascularization (TVR)|240 days||||percentage of participants||95% Confidence Interval|Number
1400788|NCT01257230|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0–3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
1400789|NCT01257230|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0–3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
1400790|NCT01257230|Secondary|Trough FVC Change From Baseline|"Change from baseline of Trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 24 weeks of treatment.~The measured values presented are actually adjusted means.."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
1400791|NCT01257230|Secondary|FVC peak0-3 Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 h after administration of trial medication (FVC peak0–3h) after 24 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
1400792|NCT01257230|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 24.~The measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
1400793|NCT01257230|Primary|FEV1 peak0-3 Change From Baseline|"Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24.~Note, the measured values presented are actually adjusted means."|Baseline and 24 weeks|Full analysis set (FAS) was the same as the treated set which included all randomised patients who were dispensed trial medication and received at least one documents dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit, completely missing visits were handled by the statistical model.|||Litres||Standard Error|Mean
1400794|NCT01257217|Secondary|Patient Reported Outcomes at Month 3|The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||units on a scale||Standard Deviation|Mean
1400795|NCT01257217|Secondary|Mean Radner Reading Speed|Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||wpm||Standard Deviation|Mean
1400796|NCT01257217|Secondary|Mean Refractive Spherical Equivalent at Month 3|A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||diopter||Standard Deviation|Mean
1400797|NCT01257217|Secondary|Uncorrected Visual Acuity Across a Range of Distances at Month 3|VA was tested binocularly unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||logMAR||Standard Deviation|Mean
1400798|NCT01257217|Secondary|Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3|Visual acuity (VA) was tested binocularly (both eyes together) with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||logMAR||Standard Deviation|Mean
1400799|NCT01257217|Primary|Mean Binocular Defocus VA at Month 3|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 3 from second eye implantation|This analysis population includes all subjects who received IOLs without major deviations and/or surgical complications.|||logMAR||Standard Deviation|Mean
1400800|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From end of treatment period up to Week 48 (follow-up period)|All follow-up participants.|||participants|||Number
1400801|NCT01257204|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.|Baseline (Day 1) up to 24 weeks (treatment period)|All treated participants.|||participants|||Number
1400802|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
1400803|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 3. Here, n signifies the number of participants evaluable for the respective category."|||participants|||Number
1400804|NCT01257204|Secondary|Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA <LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory."|Baseline up to Week 48|"All treated participants with HCV genotype 2. Here, n signifies the number of participants evaluable for the respective category."|||participants|||Number
1400805|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
1400806|NCT01257204|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2|SVR12 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants with HCV genotype 2.|||percentage of participants||80% Confidence Interval|Number
1400807|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
1400808|NCT01257204|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2|cEVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants with HCV genotype 2.|||percentage of participants||80% Confidence Interval|Number
1400809|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 3.|||percentage of participants||80% Confidence Interval|Number
1400810|NCT01257204|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2|RVR was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants with HCV genotype 2.|||percentage of participants||80% Confidence Interval|Number
1400811|NCT01257204|Primary|Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2|SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants with hepatitis C virus genotype 2.|||percentage of participants||80% Confidence Interval|Number
1400812|NCT01256983|Primary|Bedtime|"The mean bedtime assessed by actimetry of each 3 week period (day 21, 42, 63 ) was used as outcome to be compared with the control group.~Bedtime is expressed in time (hours and minutes)"|Mean Bedtimes over 21 days for each period||||Hours||Standard Deviation|Mean
1400813|NCT01256944|Primary|Impaired Glucose Tolerance|Impaired glucose tolerance was defined as two hour glucose levels of 7.8–11.1 mmol/L in the 75 g oral glucose tolerance test. In women with impaired glucose tolerance, the fasting plasma glucose level should be <7 mmol/L.|1 years||||percentage of participants|||Number
1400814|NCT01256944|Primary|LDL|"Lipid profiles, including total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and sex hormone binding globulin (SHBG).~Abnormal LDL was ≧4.14mmol/L."|1 year||||mmol/L||Standard Deviation|Mean
1400815|NCT01256944|Primary|HDL|"Metabolic syndrome was defined (2005 National Cholesterol Education Program, Adult Treatment Panel III) as the presence of at least three of the following criteria:~abdominal obesity (waist circumference >80 cm in women); serumtriglycerides≥1.7 mmol/L; serumHDL<1.3 mmol/L; systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg; and fasting plasma glucose ≥7.0 mmol/L."|1 year||||mmol/L||Standard Deviation|Mean
1400816|NCT01256944|Primary|Triglycerides|Abnormal serum triglycerides defined as ≥ 1.7 mmol/L|1 year||||mmol/L||Standard Deviation|Mean
1400817|NCT01256944|Primary|Cholesterol|Hypercholesterolemia was defined as >6 mmol / L.|1 year||||mmol/L||Standard Deviation|Mean
1400818|NCT01256944|Primary|Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR)|HOMA-IR = [fasting insulin (in μIU/mL) × fasting glucose (in mg/dL)]/405.|1 year||||unitless||Standard Deviation|Mean
1400819|NCT01256944|Primary|Two Hour Glucose|"2-hour postprandial blood sugar measures blood glucose exactly 2 hours after you start eating a meal. This is not a test used to diagnose diabetes.~World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year||||mmol/L||Standard Deviation|Mean
1400820|NCT01256944|Primary|Fasting Glucose|"Fasting blood sugar (FBS) measures blood glucose after you have not eaten for at least 8 hours. It is often the first test done to check for prediabetes and diabetes.~World Health Organization 2006 diagnostic criteria for diabetes were employed (fasting plasma glucose ≥7.0 mmol/L or two hour plasma glucose ≥11.1 mmol/L)."|1 year||||mmol/L||Standard Deviation|Mean
1400821|NCT01256944|Primary|Fasting Insulin|A fasting serum insulin level of greater than the upper limit of normal for the assay used (approximately 60 pmol/L) is considered evidence of insulin resistance.|1 year||||μIU/ml||Standard Deviation|Mean
1400822|NCT01256944|Primary|BMI|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).|1 year||||kg/m2||Standard Deviation|Mean
1400823|NCT01256944|Primary|Total Testosterone|Using serum total testosterone to represent the severity of hyperandrogenism.|1 year||||nmol/L||Standard Deviation|Mean
1400824|NCT01256918|Primary|Correlation Between Lens Thickness and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between~length thickness measurement using A scan biometer for each cataract and~penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery||||units on a scale||Standard Deviation|Mean
1400825|NCT01256918|Primary|Correlation Between Nuclear Opalescence and Phacodepth|"Pearson correlation coefficient would be calculated to look for any correlation between~nuclear opalescence as per LOCS III grading system for each cataract and~penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens"|day 0 of surgery||||units on a scale||Standard Deviation|Mean
1400826|NCT01256918|Primary|Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification|the nuclear colour grading as per LOCS III criteria for each case and the depth of penetration of phacotip required during a vertical chop was analysed to look for any correlation between the two.|day 0 of surgery||||units on a scale||Standard Deviation|Mean
1400827|NCT01256918|Secondary|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .|day 0 of surgery.|". In this observational study sample size was achieved by consecutive sampling of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria from Nov.2010 till March 2011 ,after a written informed consent.~Occurence of any posterior capsular rupture during vertical chop was noted as per protocol."|||participants|||Number
1400828|NCT01256918|Primary|Phacodepth Required to Achieve Full Thickness Nuclear Crack|phacodepth is the term used to describe the depth penetrated by the phacotip into the substance of lens.A note of depth penetrated by the tip to achieve full thickness nuclear crack shall be made.|day 0 of surgery|A consecutive sample of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria, were enrolled in the study starting Nov.2010 till Jan 2011 ,after a written informed consent.|||mm||Standard Deviation|Mean
1400921|NCT01256177|Secondary|The Proportion of Patients at Week 8 With a Clinical Global Impression – Bipolar - Change (CGI-BP-C) of “Much” or “Very Much” Improved|Clinical Global Impression - Bipolar - Change (CGI-BP-C) of “much” or “Very much” improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved.|After 8 weeks of start of treatment|Full Analysis Set|||Participants|||Number
1400829|NCT01256840|Primary|Telomere Length|This study is not a clinical trial, but the UCSF Committee on Human Research requires registration with clinicaltrials.gov. It is a ONE TIME POINT study, where we get a simple blood draw from people from three groups - calorie restricting, normal eating, and obese. Therefore, there IS NO FOLLOW UP/time frame. The outcome measure is assessed on the day of the study. Telomere length is a marker of cellular aging and is used to understand how the cells are aging. We will investigate whether long-term caloric restriction is associated cross-sectionally with longer telomere length (less aging).|One day||||ratio||Standard Deviation|Mean
1400830|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1400831|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1400832|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1400833|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to DHEA suppositories, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were then analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1400834|NCT01256684|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who have self-identified moderate to severe vaginal dryness at Baseline.|||units on a scale||Standard Error|Mean
1400835|NCT01256684|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1400836|NCT01256684|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
1400837|NCT01256684|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent-to-Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of superficial cells||Standard Error|Mean
1400922|NCT01256177|Secondary|Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar – Severity (CGI-BP-S)|CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease|Baseline to Week 8|Full Anlaysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=112)|||Scores on a scale||Standard Error|Least Squares Mean
1400838|NCT01256684|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cell was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including the basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of parabasal cells||Standard Error|Mean
1400839|NCT01256671|Primary|Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels|The long-term safety of intravaginal prasterone has been evaluated on different parameters including the serum levels of DHEA and its metabolites. For this purpose, blood samples were collected at Baseline and different post-Baseline timepoints for the determination of serum steroid levels by a central laboratory using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The serum levels of dehydroepiandrosterone (DHEA), estradiol (E2) and testosterone (TESTO) obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|Data are presented for subjects in the Safety Population who have steroid data at both baseline and Week 52.|||pg/mL||Standard Error|Mean
1400840|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching|The severity of irritation/itching was evaluated by a questionnaire. The severity of irritation/itching recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS irritation/itching (being or not most bothersome (MBS)) (n=86); the analysis MBS/MS only includes subjects with MS irritation/itching being MBS (n=23)."|||units on a scale||Standard Error|Mean
1400841|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS only includes subjects having MS dryness (being or not most bothersome (MBS)) (n=251); the analysis MBS/MS only includes subjects with MS dryness being MBS (n=81)."|||units on a scale||Standard Error|Mean
1400842|NCT01256671|Secondary|Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Overall, 476 subjects met vulvovaginal atrophy (VVA) criteria by having moderate/severe (MS) dyspareunia, dryness and/or irritation/itching. The analysis MS dyspareunia only includes subjects having MS dyspareunia (being or not most bothersome (MBS)) (n=240); the analysis MBS/MS only includes subjects with MS dyspareunia being MBS (n=183)."|||units on a scale||Standard Error|Mean
1400843|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal pH.|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."|||pH||Standard Error|Mean
1400844|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells).|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."|||percentage of superficial cells||Standard Error|Mean
1400845|NCT01256671|Secondary|Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells).|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 52 as well as the change from Baseline to Week 52 are presented.|Baseline and Week 52|"Subgroups of the Safety Population were used for analysis. The subgroup identified ALL includes subjects meeting or not the vulvovaginal atrophy (VVA) criteria at Baseline while the subgroup VVA only includes subjects meeting VVA criteria (pH ˃5, superficial cells ≤ 5% and moderate/severe VVA symptom being most bothersome (MBS))."|||percentage of parabasal cells||Standard Error|Mean
1400846|NCT01256671|Primary|Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium|The long-term safety of intravaginal prasterone has been evaluated on different parameters including the endometrium. For this purpose, endometrial biopsies were performed at screening and at the end of the study (52 weeks) or at discontinuation visit for women who were exposed to intravaginal DHEA (prasterone) for at least 12 weeks. At screening, the endometrium had to be atrophic/inactive for women to be enrolled in the study. Only the end-of-study data are presented.|Baseline and Week 52 (or discontinuation)|Only subjects in the Safety Population who had an end-of-study endometrial biopsy are included in the analysis.|||Participants|||Count of Participants
1402029|NCT01247220|Secondary|Retinal Thickness|central foveal thickness on optical coherence tomography|6 and 12 months||||microns||Standard Deviation|Mean
1400847|NCT01256658|Secondary|Cumulative Number of Subjects With Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL From Week 1 to Week 50|"Cumulative number of asymptomatic carriers having Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) from Week 1 to Week 50, was measured from group of participants diagnosed as asymptomatic carriers at Community Screening Campaign (CSC1)/Day1. Number of participants affected before and after diagnosed with ≥1 symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) (complicated and uncomplicated episodes combined). Number of SMRC5000s was detected by Rapid Diagnostic Test (RDT) using a blood sample from each participant and later confirmed to have a parasite density > or = 5000/uL by microscopy.~Week (1-2) indicates day1 to day14, week (3-4) indicates day 15 to day 28, week (5-6) indicates day 29 to day 42, etc. After first diagnosis of asymptomatic carriers at CSC1/Day1."|Week 1 to Week 50|Individual subject data from eligible randomized participants from Community Screening Campaign 1 (CSC1) for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and available form analysis and census data was obtained as per protocol.|||participants|||Number
1400848|NCT01256658|Secondary|Number of Asymptomatic Carriers With Complicated and Uncomplicated Episodes Combined|Number of asymptomatic carriers diagnosed with 1 Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000), 2 SMRC5000, 3 SMRC5000 and >3 SMRC5000 (complicated and uncomplicated episodes combined). Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy.|12 months - period 1|Individual subject data from eligible clusters set defined as all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) was collected and census data was obtained as per protocol.|||participants|||Number
1400849|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000) in Asymptomatic Carriers at Any Time of Diagnosis (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000) in asymptomatic carriers by study arm from all inhabitants diagnosed at any time for asymptomatic carriers. Number of SMRC5000s is measured by Rapid diagnostic test (RDT) and later confirmed to have a parasite density ≥ 5000/uL by microscopy."|12 months - period 1|The number of units represents the number of clusters that include all participants randomized for which data on Symptomatic malaria episode, RDT-confirmed (SMRCs) were collected and census data were obtained as per protocol.|||percentage of participants|Participants|Standard Deviation|Mean
1400850|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in Infants and Children (>6 Months and <5 Years)- Cluster Data|"Data is presented per cluster. Cluster data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 of Community Screening Campaign 1 (CSC1) in infants and children (>6 months and <5 years) was measured by Hemoglobin levels based on microscopy reading.~Mean and Standard Deviation (SD) percent were measured indicating the mean and SD of percentages of cluster frequencies under the study arm for that particular category."|Day 1 to day 28 - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Deviation|Mean
1400851|NCT01256658|Secondary|Number of Asymptomatic Carriers With Increase in Hemoglobin Levels by at Least 0.5 g/dL From Community Screening Campaign 1 (CSC1) Infants and Children (>6 Months and <5 Years)- Individual Data|Individual data of number of asymptomatic carriers with increase in hemoglobin levels by at least 0.5 g/dL from Day 1 to Day 28 from Community Screening Campaign 1 (CSC1) infants and children (>6 months and <5 years). Hemoglobin levels were measured using the HemoCue® rapid test. This test was performed with a drop of blood collected from the fingertip at Day 1 and at Day 28.|Day 1 to Day 28- period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data was obtained as per protocol.|||participants|||Number
1400852|NCT01256658|Secondary|Percentage of Microscopy-confirmed Gametocyte Carriers Treated With COA566 for Asymptomatic Carriers|Percentage of microscopy-confirmed gametocyte asymptomatic carriers treated with COA566 for asymptomatic carriers in Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3).|Day 1, day 7 and day 28 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.|||percentage of participants|||Number
1400853|NCT01256658|Secondary|Percentage of COA566-treated Microscopy-confirmed Asymptomatic Carriers at Community Screening Campaign 1, 2 and 3 (CSC1, CSC2 and CSC3) With Parasitological Cure Rate at Day 7|Percentage of participants with parasitological cure confirmed via microscopy at day 7 after treatment with COA566. This assessment was done on asymptomatic carriers from Community Screening Campaigns 1, 2 and 3 (CSC1, CSC2 and CSC3) from the intervention group only.|Day 7 of CSC1, CSC2 and CSC3 - period 1|Treated asymptomatic carriers from CSC1, CSC2 and CSC3 confirmed by microscopy and treated with study medication. Subjects are counted multiple times if diagnosed and treated more than once during the study. Subjects missing day 7 parasitemia data are excluded. Percentages are based on the number of subjects treated with any formulation.|||percentage of participants|||Number
1400854|NCT01256658|Secondary|Hemoglobin Level (g/dL) in Community Screening Campaign 1 (CSC1)/Day 1 and CSC4/Day 1 by Study Arm and Age Group (Per Cluster)|"Data is presented per cluster. Hemoglobin levels at Community Screening Campaign 1 and 4 (CSC1 and CSC4) on day 1 per age group (5-9 years, 10-14 years, and ≥15 years) in the intervention versus the control arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all randomized participants (ages 5-9 years, 10-14 years, and ≥15 years) clusters for which CSC1 and CSC4 was conducted, data was available, and census data were obtained as per protocol.|||g/dL|Participants|Standard Deviation|Mean
1400923|NCT01256177|Secondary|Change From Baseline to Week 8 in HAM-D Total Scores|HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114).|||Scores on a scale||Standard Error|Least Squares Mean
1400855|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 4 (CSC4)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 4 (CSC4/Day 1) in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC4 was conducted, data was available, and census data was obtained as per protocol.|||participants|||Number
1400856|NCT01256658|Secondary|Anemia Status Based on Community Screening Campaign 1 (CSC1)/Day 1 in Infants and Children (>6 Months and <5 Years)|Anemia status based on Community Screening Campaign 1 (CSC1)/Day 1 in infants and children (>6 months and <5 years) was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 (CSC1/day 1) - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.|||participants|||Number
1400857|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in Infants and Children (>6 Months and <5 Years) for Asymptomatic Carriers at CSC1|Change in hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to CSC1/Day 28 in infants and children (>6 Months and <5 Years) for asymptomatic carriers at CSC1 was measured via hemoglobin levels using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant. The anemic status is defined as follows: hemoglobin (Hb) <5 g/dL = severe anemia, Hb 5 to <8 g/dL = moderate anemia, Hb 8 to <11 g/dL = mild anemia, Hb ≥11 g/dL = no anemia).|Day 1 and day 28 - period 1|Individual subject data from eligible clusters set defined as all infants and children (>6 months and <5 years) randomized for which CSC1 was conducted, data was available, and census data were obtained as per protocol.|||g/dL||Standard Deviation|Mean
1400858|NCT01256658|Secondary|Number of Microscopy and qRT-PCR-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4)|Number of gametocyte carriers at Community Screening Campaign 4 (CSC4) was measured via microscopy and confirmed using Quantitative Reverse Transcription PCR (qRT-PCR) at day 1 of CSC4.|Month 12 (CSC4/day 1) - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.|||participants|||Number
1400859|NCT01256658|Secondary|Mean Number of Microscopy-confirmed Gametocyte Carriers at Day 1 of Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of gametocyte carriers at Day 1 for Community Screening Campaign 1,2,3,4 (CSC1, CSC2, CSC3 and CSC4) was measured using gametocyte assessments (prevalence and density) via microscopy.~Mean measured in this analysis is the mean percent indicating the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|Eligible clusters set consisted of all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Deviation|Mean
1400860|NCT01256658|Secondary|Mean of Microscopy-confirmed Asymptomatic Carriers From Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) (Per Cluster)|"Data is presented per cluster. Mean number of asymptomatic carriers from Community Screening Campaigns 1, 2, 3 and 4 (CSC1, CSC2, CSC3 and CSC4) was measured by confirmed positive microscopy for P. falciparum asexual forms in participants with absence of clinical signs and symptoms of malaria.~Mean measured in this analysis is the mean percent indicting the mean of percentages of cluster frequencies under the study arm for that particular category."|12 months - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC 1, 2 3 and 4 was conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Deviation|Mean
1400861|NCT01256658|Secondary|Number of Participants (Infants and Children (> 6 Months and < 5 Years)) With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (infants and children (> 6 months and < 5 years)) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable carriers set consisted of all infants and children (> 6 months and < 5 years)) from intervention clusters confirmed positive for P. falciparum asexual forms at any CSC or when migrating into the cluster, who in the absence of clinical signs and symptoms received at least one dose of COA566 for the diagnosed asymptomatic infection.|||participants|||Number
1400862|NCT01256658|Secondary|Number of Participants With Hospitalizations, Severe Malaria Episodes or Death Post Community Screening Campaign (CSC)|Total number of participants (all ages) with hospitalizations, severe malaria episodes or death after Community Screening Campaign (CSC) was assessed.|12 months - period 1|Safety analyzable asymptomatic carriers set consisted of all consenting inhabitants from intervention clusters confirmed positive by RDT for P. falciparum asexual forms at any CSC or when migrating into the cluster, in the absence of clinical signs and symptoms who received at least one dose of COA566 to treat the diagnosed asymptomatic infection.|||participants|||Number
1400863|NCT01256658|Secondary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Post Community Screening Campaign (CSC)|"Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in post Community Screening Campaign (CSC), by study arm (individual level data) was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all subjects in post CSC. Person-year observed: sum of duration (in days) in post CSC for all subjects present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|12 months - period 1|Individual subject data from eligible clusters set defined as all randomized participants for which CSCs 1, 2, 3 and 4 were conducted, data was available, and census data were obtained as per protocol.|||SMRC5000 per person-year|||Number
1400864|NCT01256658|Secondary|Change in Hemoglobin Level (g/dL) From Community Screening Campaign 1(CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 (Per Cluster)|"Data is presented per cluster. Comparison of hemoglobin level (g/dL) from Community Screening Campaign 1 (CSC1)/Day 1 to Community Screening Campaign 4 (CSC4)/Day 1 in infants and children (>6 months and <5 years) by study arm was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each participant."|Day 1 (CSC1/day 1) and month 12 (CSC4/day 1) - period 1|The number of units represents the number of clusters that include all infants and children (>6 months and <5 years) randomized participants for which CSCs 1 and 4 were conducted, data was available, and census data were obtained as per protocol.|||g/dL|Participants|Standard Deviation|Mean
1400865|NCT01256658|Secondary|Microscopy Confirmed Asymptomatic Carriers of P. Falciparum at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmation of asymptomatic carriers of P. falciparum at Community Screening Campaign 4 (CSC4) was conducted at month 12. Blood films were histologically treated and examined microscopically. When it was ascertained that P. falciparum was present, a count of the asexual forms against leukocytes was made using a tally counter."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data was obtained as per protocol.|||participants|Participants|Standard Error|Mean
1400866|NCT01256658|Secondary|Microscopy-confirmed Gametocyte Carriers at Community Screening Campaign 4 (CSC4) (Per Cluster)|"Data is presented per cluster. Microscopy confirmed gametocyte carriers at Community Screening Campaign 4(CSC4) were assessed via microscopy at month 12 of period 1. Blood films were histologically treated and examined microscopically."|Month 12 - period 1|The number of units represents the number of clusters that include all randomized participants for which CSC4 was conducted, data was available, and census data were obtained as per protocol.|||participants|Participants|Standard Error|Mean
1400867|NCT01256658|Primary|Change in Hemoglobin Level (g/dL) in Asymptomatic Carriers >6 Months of Age (Per Cluster)|"Data is presented per cluster. Change in hemoglobin levels from day 1 to day 28 was measured using the HemoCue® rapid test. This test was performed using a drop of blood collected from the fingertip of each asymptomatic carrier from Community Screening Campaign 1 (CSC1), > 6 months of age, at day 1 and at day 28."|Day 1 and day 28 of period 1|The number of units represents the number of clusters that include all randomized, > 6 months of age participants for which CSC1 was conducted, data was available and census data were obtained as per protocol.|||g/dL|Participants|Standard Deviation|Mean
1400868|NCT01256658|Primary|Number of Symptomatic Malaria Episode, RDT-confirmed, With Parasitemia ≥5000/μL (SMRC5000s) Per Person-year in Infants and Children (<5 Years) in Post Community Screening Campaign (CSC) at Month 12 (Per Cluster)|"Data is presented per cluster. Number of Symptomatic malaria episode, RDT-confirmed, with parasitemia ≥5000/μL (SMRC5000s) per person-year in infants and children (<5 years) in post Community Screening Campaign (CSC) at month 12 was detected by Rapid Diagnostic Test (RDT) (using a blood sample from each participant) and later confirmed to have a parasite density ≥5000/uL by microscopy.~Number of SMRC5000: sum of all SMRC5000 for all infants and children (<5 years) in post CSC.~Person-year observed: sum of duration (in days) for all infants and children (<5 years) in post CSC present in study /365.25.~Number of SMRC5000 per person-year = number of SMRC5000/person-year observed."|Month 12 of period 1|The number of units represents the number of clusters that include all randomized infants and children (<5 years) for which CSCs 1, 2, and 3 were conducted, data was available, and census data were obtained as per protocol.|||SMRC5000 per person-year|Participants|Standard Deviation|Mean
1400869|NCT01256567|Secondary|Steady State Volume of Distribution (Vss) of Ramucirumab||Day 1 of Cycle 1 and 4 (cycle=21 days)|All participants with evaluable Vss data at the specified time points.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1400870|NCT01256567|Secondary|Clearance (Cl) of Ramucirumab|Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable clearance data at the specified time points.|||milliliters per hour (mL/hr)||Geometric Coefficient of Variation|Geometric Mean
1400871|NCT01256567|Secondary|Half Life (t 1/2) of Ramucirumab||Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable t1/2 data at the specified time points.|||days||Geometric Coefficient of Variation|Geometric Mean
1400872|NCT01256567|Secondary|Area Under the Curve (AUC) of Ramucirumab|AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided.|Day 1 of Cycles 1 and 4 (cycle=21 days)|All participants with evaluable AUC data at the specified time points.|||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
1400873|NCT01256567|Secondary|Maximum Concentration (Cmax) of Ramucirumab|Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided.|Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)|All participants with evaluable Cmax data at the specified time points.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1400874|NCT01256567|Secondary|Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)|The number of participants with a positive anti-IMC-1121B titer at any point during the study.|Baseline up to data cut off (approximately 48.3 weeks)|All participants with evaluable antibody assessment data.|||participants|||Number
1400875|NCT01256567|Primary|Number of Participants With Adverse Events|Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.|Baseline up to data cut off (approximately 48.3 weeks)|All participants who received at least 1 dose of study drug.|||participants|||Number
1402030|NCT01247220|Secondary|Number of Ranibizumab Injections|Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in second six months of observation period|12 months||||injections||Full Range|Mean
1400876|NCT01256502|Secondary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at Other Time Points|Investigator satisfaction with SERI® Surgical Scaffold was evaluated at Stage II surgery and Months 12, 18 and 24 after surgery/implantation using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|Stage 2 Surgery, Months 12, 18 and 24|Participants from the Full Analysis population (139 participants, 214 breasts), all enrolled participants who had SERI® Surgical Scaffold surgery/implant, with data at the given time-point.|||units on a scale||Standard Deviation|Mean
1400877|NCT01256502|Secondary|Investigator Ease of Use Assessment at the Time of SERI® Placement During Stage I Surgery|Ease of Use assessments of SERI® Surgical Scaffold by the investigator were collected on Case Report Forms (CRFs) following stage I surgery. Ease of Use was assessed separately using a 5-point scale, where 0=very difficult to 5=very easy to use for the following criteria: • SERI® preparation before implantation (excluding cutting or shaping) • SERI® cutting and shaping before implantation • SERI® positioning/drapability during implantation • SERI® cutting and shaping after implantation • SERI® suturing during implantation (including tension and stretch). The number of participants who were implanted with SERI® Surgical Scaffold (n=139) by Investigator Ease of Use response for each category is reported.|Immediately following Stage I surgery|Full analysis population included all enrolled participants who had SERI® Placement during Stage I Surgery.|||participants|||Number
1400878|NCT01256502|Primary|Investigator Satisfaction Following Use of SERI® Surgical Scaffold at 6 Months|The primary outcome measure was investigator satisfaction at 6 months after stage I surgery/implantation of SERI® Surgical Scaffold. Satisfaction was evaluated using an 11-point scale, where 0=very dissatisfied to 10=very satisfied.|6 months|Of the 139 participants, 214 breasts, implanted with SERI® during Stage I breast reconstruction, 4 discontinued the study and 1 missed the 6-month visit, leaving 134 subjects, 205 breasts in the primary analysis population.|||units on a scale||Standard Deviation|Mean
1400879|NCT01256476|Primary|Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12||Baseline and 12 weeks|All randomized subjects who took at least 1 dose of double-blind study drug, had a baseline efficacy measurement, and had at least 1 valid post-baseline efficacy measurement.|||percent||Standard Error|Mean
1400880|NCT01256450|Secondary|Use of Rescue Medication|Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.|Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication|||Tablets per day||Standard Deviation|Mean
1400881|NCT01256450|Secondary|Change From Baseline to Week 12 in Investigator’s Overall Satisfaction With Study Drug|Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
1400882|NCT01256450|Secondary|Change From Baseline to Week 12 in Subject’s Overall Satisfaction With Study Drug|Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
1400883|NCT01256450|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication|||units on a scale||Standard Deviation|Mean
1400884|NCT01256450|Secondary|Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM|The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject’s satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction. Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
1400885|NCT01256450|Secondary|Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale|Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
1400886|NCT01256450|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1400887|NCT01256450|Secondary|Number of Participants With Response to Treatment as Assessed by an NRS Scale|Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||participants|||Number
1400888|NCT01256450|Secondary|Change From Baseline in Pain Intensity Over Time Using NRS Scale|Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
1400889|NCT01256450|Primary|Change in Pain Intensity From Baseline to Week 12|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit – average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on Intent-to-Treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication.|||units on a scale||Standard Deviation|Mean
1400890|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 9 Months After First Treatment|Response was defined as absence of HSIL, and absence of oncogenic HPF if LSIL|9 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.|||percentage of participants|||Number
1400891|NCT01256424|Post-Hoc|Comparison of Response Rates of Three Different Doses of HAL PDT and Placebo at 6 Months After First Treatment.|Response was defined as absence of HSIL, and absence of oncogenic HPV if LSIL.|6 months after first treatment|Patients diagnosed with HSIL histology by a panel of pathologists were included in the analysis.|||percentage of participants|||Number
1400892|NCT01256424|Secondary|Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|HPV response was defined as clearance of baseline HPV infection, asssessed by genotype|3 months after treatment|Patients with CIN2 at baseline, based on central histology read, and HPV positive at baseline|||percentage of patients|||Number
1400893|NCT01256424|Primary|Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.|Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.|3 months after last treatment|Patients with CIN2 at baseline, based on central histology review|||percentage of patients|||Number
1400894|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||Participants|||Number
1400895|NCT01256411|Secondary|Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)|Blood pressure (BP) control is defined as BP <140/90 mmHg.|Baseline to 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||Participants|||Number
1400896|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 combination group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||mmHg||Standard Deviation|Mean
1400897|NCT01256411|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)|Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.|Baseline, 12 months|Treated set: The treated set included all participants who received at least one dose of extension study medication. One participant in the LCZ696 400 mg/Amlodopine group discontinued after 1 day in the extension study without having any BP measurements taken during the extension. Therefore, this participant was excluded from the analysis.|||mmHg||Standard Deviation|Mean
1400898|NCT01256411|Primary|Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)|Participants were monitored throughout the study for adverse events, serious adverse events and deaths.|Baseline to 12 months|Actual extension treatment received: The participants are included in each treatment group for which they received treatment. For example, if a participant started on LCZ696 200 mg but was then down-titrated to LCZ696 100 mg, the participant was counted once in the LCZ696 100 mg group and once in the LCZ696 200 mg group.|||Participants|||Number
1400899|NCT01256385|Secondary|Percentage of Responses/Disease Stabilization for Patients Crossing Over to the Combination Therapy After Progressing on Arm B.|Assessed according to RECIST. This is includes complete and partial responses as well as stable disease, and is different from Outcome Measure 6 above, which includes only complete and partial responses.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1400900|NCT01256385|Secondary|PFS of Myofibroblast (+) Cohort||From start of treatment to time of progression or death of any cause, assessed up to 5 years|Myofibroblast status was not determined. Concerns about the validity/technical feasibility as well as availability of the assay led us to decide to not perform the assay. We do not intend to perform this assay anymore.||||||
1400901|NCT01256385|Secondary|Percentage of Responses After Crossover From Control Arm to the Combination Arm, Assessed According to RECIST|Percentage of responses (if any) after crossover from the control arm to the combination arm will be evaluated qualitatively. This is includes complete and partial responses, and is different from Outcome Measure 8 below, which includes complete and partial responses as well as stable disease.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1400902|NCT01256385|Secondary|Grade 3 or Higher Hematological Toxicity|Incidence of hematological toxicities at least possibly related to study drug, graded based on Common Terminology Criteria for Adverse Events version 4|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1400944|NCT01256008|Primary|Hamilton Anxiety Scale (HAMA-14)|"The scale(HAMA-14) is used to assessed the anxiety symptoms of patients.~The scale range is 0-56.Higher value represents a worse outcome.~The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week."|baseline,2 w,4 w,8 w,12 w,16 w,24 w||||units on a scale||Standard Deviation|Mean
1400903|NCT01256385|Secondary|PFS vs. Historical Control Cohort|PFS at 4 months in Arm A and Arm B will each be compared with a 4-month historical control rate of 21.4%. The historical data appears in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568 and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343.|From start of treatment to time of progression or death of any cause, assessed at 4 months|Note: Each arm is separately compared to an historical rate of 21.4%, based on a one-sided test at the 0.05 significant level. Since the 90% CIs each exclude 21.4%, the 4-month PFS rate in both arms exceeds the fixed historical control rate.|||percentage of participants||90% Confidence Interval|Number
1400904|NCT01256385|Secondary|Overall Response Rates (OR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Statistics reported are for Overall Response (OR) = CR + PR.|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
1400905|NCT01256385|Secondary|Overall Survival (OS)|Time from randomization until death from any cause|Up to 5 years||||days||95% Confidence Interval|Median
1400906|NCT01256385|Primary|Progression-free Survival (PFS)|Progression determined using RECIST criteria: >=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.|From start of treatment to time of progression or death from any cause, assessed up to 5 years||||days||95% Confidence Interval|Median
1400907|NCT01256294|Primary|Dose-normalized Maximum Plasma Drug Concentration (Cmax) at Steady State|Maximum (peak) plasma drug concentration after drug administration at steady state (after 14 days of treatment with each study drug). Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor.|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
1400908|NCT01256294|Secondary|Number of Participants With Reported Biopsy Proven Acute Rejection Episodes||28 Days|Full analysis set.|||participants|||Number
1400909|NCT01256294|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. An SAE was an event which: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; required or prolonged inpatient hospitalization; was medically significant, i.e., an event that jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|28 Days|Safety set|||participants|||Number
1400910|NCT01256294|Secondary|Trough Plasma Drug Concentration (C0) at Steady State|Trough plasma drug concentration measured prior to drug administration at steady state (after 14 days of treatment with each study drug).|Days 14 and 28: predose|PK analysis set, where data were available.|||ng/mL||Standard Deviation|Mean
1400911|NCT01256294|Secondary|Intra-patient Variability of Tacrolimus Pharmacokinetic Parameters|The intra-patient variability of tacrolimus pharmacokinetics of each formulation was evaluated by comparing AUC0-12h, maximum drug concentration (Cmax) and trough drug concentration (C0) at Days 7 and 14, and Days 21 and 28. Intra-patient variability was assessed by a calculation of the coefficient of variation, by patient, using the repeated measurements within each Period, where the coefficient of variation (%) = standard deviation/mean*100.|Days 7 and 14, and Days 21 and 28.|PK Analysis set.|||percent coefficient of variation||Standard Error|Mean
1400912|NCT01256294|Primary|Dose-Normalized Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) at Steady State|"Dose-normalized area under the concentration-time curve from time 0 to 12 hours (AUC0-12h) at steady state after 14 days of treatment with each study drug.~Geometric mean and 95% confidence intervals were determined from an analysis of variance (ANOVA) model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and patients nested within sequences as a random factor."|Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing.|Pharmacokinetic (PK) analysis set included the subset of patients from the Full Analysis Set (all patients to whom study medication had been assigned) with evaluable PK data.|||ng*hr/mL/mg||95% Confidence Interval|Geometric Mean
1400913|NCT01256281|Primary|Pain Score in Legs (0-10)|"Pain score in legs at 2-4 hours after intervention will be the primary outcome.~Data analysis not done."|2-4 hours after intervention|||||||
1400914|NCT01256190|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes||||participants|||Number
1400915|NCT01256190|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes||||participants|||Number
1400916|NCT01256190|Secondary|Incidence of Hemostasis at 5 Minutes|Number of subjects in each group that achieved hemostasis at pre-specified times after treatment|5 minutes||||participants|||Number
1400917|NCT01256190|Secondary|Safety|Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS)|28 days|All subjects treated were analyzed for safety. There were 39 subjects treated with Fibrocaps and 16 treated with gelatin sponge only, since 1 gel sponge subject was randomized but not treated.|||participants|||Number
1400918|NCT01256190|Primary|Time to Hemostasis|Time from application of treatment to cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis|||minutes||Standard Deviation|Mean
1400919|NCT01256177|Secondary|Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)|The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease.|After 8 weeks of start of treatment|Full Analysis Set|||Participants|||Number
1402031|NCT01247220|Primary|Visual Acuity|ETDRS visual acuity|6 and 12 months||||letters on ETDRS Visual Acuity Chart||Standard Deviation|Mean
1400924|NCT01256177|Secondary|Change From Baseline to Each Assessment in MADRS Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe.|Baseline to Week 8|Full Analysis Set (Number of participants at each assessment : Baseline (Placebo=140, Quetiapine XR= 139), Week 1 (Placebo=140, Quetiapine XR= 139), Week 2 (Placebo=127, Quetiapine XR= 128), Week 4 (Placebo=114, Quetiapine XR= 120), Week 6 (Placebo=102, Quetiapine XR= 114), Week 8 (Placebo=100, Quetiapine XR= 114)).|||Scores on a scale||Standard Error|Least Squares Mean
1400925|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12|After 8 week of start of treatment|Full Analysis Set|||Participants|||Number
1400926|NCT01256177|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)|Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline|8 weeks from baseline|Full Analysis set|||Participants|||Number
1400927|NCT01256177|Primary|Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline|Baseline to Week 8|Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114)|||Scores on a scale||Standard Error|Least Squares Mean
1400928|NCT01256164|Secondary|Number of Patients Achieving Hemostasis at 10 Minutes||10 minutes||||participants|||Number
1400929|NCT01256164|Secondary|Number of Participants Achieving Hemostasis at 5 Minutes||5 minutes||||participants|||Number
1400930|NCT01256164|Secondary|Number of Subjects Achieving Hemostasis at 3 Minutes||3 minutes||||participants|||Number
1400931|NCT01256164|Secondary|Safety|Number of participants with Adverse events and clinically-significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the TBS|28 Days|All subjects treated were analyzed for safety.|||participants|||Number
1400932|NCT01256164|Primary|Mean Time to Hemostasis (TTH)|Time to hemostasis recorded from the first application of study treatment until cessation of bleeding|0-10 minutes|All subjects treated with a time to hemostasis were included in the analysis|||minutes||Standard Deviation|Mean
1400933|NCT01256086|Primary|PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)|The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.|60 min after application of study medication|Per Protocol Population|||mg/ml||Geometric Coefficient of Variation|Geometric Mean
1400934|NCT01256060|Other Pre-specified|Measures of Social Function - The Clinical Global Impressions - Social Scale (Baseline to Week 12)|"Social Function~a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale)."|12 Weeks||||participants|||Number
1400935|NCT01256060|Other Pre-specified|Changes in Measures of Social Cognition, Social Function, Repetitive Behaviors, and Anxiety (Baseline to Week 12)|"Social Cognition (higher score=positive response)~Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100)~Eyes Test (0-28)~Strange Stories (0-16)~Irony and Empathy (0-24)~Social Function~Aberrant Behavior Checklist (0-48) (lower score=positive response)~Behavioral Assessment System for Children (higher score=positive response); i. Social: age 8 to 11 & 15 to 18 (18-69); age 12 to 14 (21-70); ii. Functional: age 8 to 14 (10-66); age 15 to 18 (10-64)~Social Responsiveness Scale (higher score=positive response); male (34-127); female (35-142)~Anxiety (lower score=positive response)~a. Child Symptom Inventory; i. Separation: male (44-106); female (44-101); ii. Generalized: male (40-101); female (41-96)~Repetitive Behaviors (lower score=positive response)~Child Yale-Brown Obsessive-Compulsive Scale (0-20)~Repetitive Behavior Scale (0-129)~Measures insensitive to change will be omitted from results."|12 Weeks||||units on a scale||95% Confidence Interval|Mean
1400936|NCT01256060|Secondary|Blood Levels of Oxytocin During the Trial in Relation to Safety or Treatment Response|Children and adolescents with minimal changes in plasma level of oxytocin after treatment will be less responsive to treatment. Children and adolescents with atypical patterns of increase in oxytocin may be more sensitive to dose-related tolerability.|12 Weeks||2016-12-31|12/2016||||
1400937|NCT01256060|Secondary|Baseline Levels of Oxytocin in Relation to Either Safety or Treatment Response|Children and adolescents with lower plasma oxytocin levels at baseline will show treatment related changes in social cognition. Children and adolescents with higher oxytocin plasma levels will show diminished or less dramatic treatment responses and may have more difficulty tolerating the treatment.|12 Weeks||2016-12-31|12/2016||||
1400938|NCT01256060|Primary|Number of Participants With Serious Adverse Events|This will be reported as the number of participants who experienced a serious advert event throughout the study.|24 Weeks||||participants|||Number
1400939|NCT01256060|Primary|Maximum Tolerated Dose (MTD)|The hypothesis is that the maximum tolerated dose in a range of 0.2-0.4 IU/kg / dose will be 0.4 IU/kg / dose, as was the case in the adult study, given that oxytocin is not stored in body fat and does not depend on liver or renal clearance.|12 Weeks||||IU / kg|||Number
1400940|NCT01256034|Secondary|Plasma IL-6, CRP, Th1/Th2 Balance||14 days|||||||
1400941|NCT01256034|Primary|Postoperative Infectious Complication||30 days||||participants|||Number
1400942|NCT01256008|Secondary|Functional Assessment of Cancer Treatment (FACT-B)|"The scale is used to assess the life quality of patients.~The scale includes 5 subscales. The scores of each scale are summed to compute a total score.~The scale range is 0-144. Higher score indicates better life quality.~The scale was assessed at baseline,4 week,12 week,24 week."|baseline, 4w,12w,24w||||units on a scale||Standard Deviation|Mean
1400943|NCT01256008|Secondary|Athens Insomnia Scale(AIS)|"The scale is used to assess the sleep quality of patients.~The scale range of AIS is 0-21. Higher score indicates worse sleep quality.~The scale was assessed at baseline,4 week,8 week,12 week,24 week"|baseline, 4w,8w,12w,24w||||units on a scale||Standard Deviation|Mean
1400948|NCT01255787|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1400949|NCT01255787|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1400950|NCT01255787|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||percentage of participants|||Number
1400951|NCT01255787|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, only participants with Baseline and at least 1 post-baseline value are included. LOCF was used.|||percentage of participants|||Number
1400952|NCT01255787|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set included all randomized participants who received at least 1 dose of study drug. One patient in the placebo arm was excluded from all datasets due to enrollment in another clinical study. Only participants with Baseline and at least 1 post-baseline value are included. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
1400953|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1400954|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with hired outside help||Standard Deviation|Mean
1400955|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Activity days missed||Standard Deviation|Mean
1400956|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with reduced household work||Standard Deviation|Mean
1400957|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with no household work||Standard Deviation|Mean
1400958|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|"The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1402032|NCT01247090|Primary|Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period||Baseline and Two Weeks||||mm Hg||Standard Deviation|Mean
1400959|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Work days with reduced work productivity||Standard Deviation|Mean
1400960|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Number of work days missed in last month||Standard Deviation|Mean
1400961|NCT01255761|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|"The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).~The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity."|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1400962|NCT01255761|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with hired outside help||Standard Deviation|Mean
1400963|NCT01255761|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Activity days missed||Standard Deviation|Mean
1400964|NCT01255761|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with reduced household work||Standard Deviation|Mean
1400965|NCT01255761|Secondary|Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Days with no household work||Standard Deviation|Mean
1400966|NCT01255761|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
1400967|NCT01255761|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Work days with reduced work productivity||Standard Deviation|Mean
1400968|NCT01255761|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12|Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient’s work productivity.|Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement.|||Number of work days missed in last month||Standard Deviation|Mean
1400969|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400970|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1402033|NCT01247064|Secondary|Parental Perception of Improvement of Breathing After Study Medication||1 hour||||percentage of participants|||Number
1400971|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400972|NCT01255761|Secondary|Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400973|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400974|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400975|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400976|NCT01255761|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400977|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1401003|NCT01255631|Primary|Pain Level on Visual Analog Scale|Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).|2 weeks|Only 7 patients completed the study by quantifying the level of their pain post-operatively on a visual analog scale from 0-10. The medication logs and two week post-op analogs could not be utilized for the analysis since all 7 patients did not complete these logs.|||units on a scale||Standard Deviation|Mean
1400978|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400979|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400980|NCT01255761|Secondary|Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12|DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.|Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of subjects|||Number
1400981|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
1400982|NCT01255761|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12|"RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient’s global status.~The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
1400983|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
1400984|NCT01255761|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
1400985|NCT01255761|Secondary|Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52|"The DAS28(ESR) score is a measure of the subject's disease activity.~DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 52|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
1401117|NCT01254409|Secondary|Terminal Elimination Half Life||Day 15||||hour||Full Range|Mean
1401118|NCT01254409|Secondary|AUC48|Area under the curve from 0 to 48 hrs post dose, with samples collected at 0.5, 0.75, 1, 1.5, 2, 3,4,6,8,12,16, 24 and 48 hours post Day 15 dose.|Day 15||||µg*hr/mL||Standard Deviation|Mean
1400986|NCT01255761|Secondary|Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12|"The DAS28(ESR) score is a measure of the subject's disease activity.~DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity."|Baseline (Week 0) to Week 12|The Full Analysis Set (FAS) consisted of all randomized subjects who had a valid Baseline and valid Post-Baseline efficacy measurement. The Last Observation Carried Forward (LOCF) was used for this analysis.|||units on a scale||Standard Deviation|Mean
1400987|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
1400988|NCT01255761|Secondary|Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|"The measurement only includes subjects that were responders at Week 12, and this is the denominator for the percentages.~The Full Analysis Set (FAS)-Nonresponse imputation (NRI) population set was used for this analysis."|||percentage of participants|||Number
1400989|NCT01255761|Secondary|Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
1400990|NCT01255761|Primary|Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined."|Baseline (Week 0) to Week 52|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
1400991|NCT01255761|Primary|Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]|"For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline.~CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined.~RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient’s global status."|Baseline (Week 0) to Week 12|Full Analysis Set (FAS) consists of all randomized subjects who had a valid Baseline & valid Post-Baseline efficacy measurement. For all binary efficacy endpoints assessing response, subjects who withdrew early or had a missing assessment at the given visit were considered nonresponders at that visit. This is known as nonresponse imputation (NRI).|||percentage of participants|||Number
1400992|NCT01255722|Secondary|Average Contrast-to-noise Ratio (Average CNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments in the ascending aorta and the in left ventricle and expressed in Hounsfield Unit (HU).~A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.~In territories where pre and post signal attenuation measures were both available, the contrast-to-noise ratio was computed according to the following formula: CNR = (Post Att – Baseline Att) / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.|||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
1400993|NCT01255722|Secondary|Average Signal-to-Noise Ratio (Average SNR)|"Signal attenuation was measured by off-site radiologists in the lumen of 4 coronary segments, in the ascending aorta and in the left ventricle and was expressed in Hounsfield Unit (HU). Measurements were set in post-injection images for the 6 territories.~A measure of noise in CT scans was collected at least in the aorta and if possible in the muscle and/or air.~Signal-to-Noise Ratios (SNR) of post-injection images were derived in all territories from attenuation measurements according to the following formula:~SNR Territory = Post Attenuation / Image Noise"|<1h|Full Analysis Set: included all patients who underwent the examination and had available assessments of the primary endpoint.|||Hounsfield Units:Hounsfield Units||Standard Deviation|Mean
1400994|NCT01255722|Secondary|Average Signal Attenuation After IV Injection of Contrast|Attenuation of signal was measured off-site on post-injection images of four coronary segments, in the ascending aorta and in the left ventricle, then it was averaged at the patient level.|<1h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Hounsfield Units||Standard Deviation|Geometric Mean
1400995|NCT01255722|Secondary|Coronary Track Rate|A post processing software automatically tracked the number of distal segments of the left anterior descending coronary artery, the left circumflex coronary artery and the right coronary artery . The number of segments tracked per patient were assessed by an independent off-site radiologist.|<24h|Full Analysis Set population: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Number of tracked segments per patient||Standard Deviation|Mean
1400996|NCT01255722|Secondary|Average Image Quality According to Off-site Reading|For each patient, all 18 coronary segments were graded for image quality using a 5-point evaluation scale (from 0=non-diagnostic to 4=excellent). The average image quality was evaluated using the off-site readings, by averaging the scores obtained for the 18 segments used to determine the CT evaluability (primary criteria).|<24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Image quality Score on a scale||Standard Deviation|Mean
1400997|NCT01255722|Primary|Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment|"Evaluability was based upon the off-site assessment of 18-coronary segments graded for image quality with a 5-point scale.4= Excellent quality, fully confidence without any doubts concerning the presence/absence of luminal stenosis; 3= Good quality, confidence concerning the presence/absence of luminal stenosis; 2= Moderate quality, relative confidence, with minor doubts concerning the presence/absence of luminal stenosis; 1= Poor quality, some doubts concerning the presence/absence of stenosis; 0= Non diagnostic.~A patient’s CT scan was considered as evaluable for identification of coronary artery stenosis if none of the 18 coronary segments had a score of 0."|< 24h|Full Analysis Set: all patients who underwent the coronary CT scan examination and had available assessments of the primary endpoint.|||Percentage of patients||Standard Error|Geometric Mean
1400998|NCT01255631|Secondary|Narcotic Pain Medications|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed.|Post-Operative Period|No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs.||||||
1400999|NCT01255631|Secondary|Lymphedema|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.||||||
1401000|NCT01255631|Secondary|Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables due to lack of post-clinical assessment data and poor patient compliance with the 14 day mark follow up.||||||
1401001|NCT01255631|Secondary|Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points.|Pre- and Post-Operative Period|No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms.||||||
1401002|NCT01255631|Secondary|Jackson Pratt (JP) Drain Output|Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study.|Post-Operative Day 1 & 2 (2 Days)|For the 7 patients who completed the study, the mean and standard deviations for the total JP drain output (in milliliters - mL) from post-operative days 1 & 2 (2 days total) were analyzed as a secondary outcome.|||milliliters (mL)||Standard Deviation|Mean
1401119|NCT01254409|Secondary|Tmax|Time of Maximum observed concentration|Day 15||||hours||Standard Deviation|Mean
1401004|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401005|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401006|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401007|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401008|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401009|NCT01255592|Secondary|Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401010|NCT01255592|Secondary|Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401011|NCT01255592|Secondary|Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401012|NCT01255592|Secondary|Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401013|NCT01255592|Secondary|Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401014|NCT01255592|Secondary|Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401120|NCT01254409|Secondary|Cmax|Maximum concentration|Day 15|Subjects who received all doses of study treatment|||µg/mL||Standard Deviation|Mean
1401015|NCT01255592|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401016|NCT01255592|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401017|NCT01255592|Secondary|Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401018|NCT01255592|Secondary|Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401019|NCT01255592|Secondary|Change From Baseline Total and Domain Scores in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)|"SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:~Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status)."|Baseline and end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
1401020|NCT01255592|Secondary|Change From Baseline for the Symptom Scores of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
1401021|NCT01255592|Secondary|Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card|The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.|Baseline and Last 7 days on treatment|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||L/min||Standard Error|Least Squares Mean
1401022|NCT01255592|Secondary|Transition Dyspnea Index (TDI) at End of Treatment (Day 28)|TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
1401023|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters/second||Standard Error|Least Squares Mean
1401024|NCT01255592|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1401025|NCT01255592|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1401026|NCT01255592|Secondary|Change From Baseline in Slow Vital Capacity (SVC)|Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.|Baseline to end of treatment (Day 28)|The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1401027|NCT01255592|Secondary|Change From Baseline in Weight of 24-hour Sputum Collection|Patients collected all sputum produced during a 24-hour period at baseline and Day 28.|Baseline and end of treatment (Day 28)|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||grams||Standard Error|Least Squares Mean
1401028|NCT01255592|Secondary|Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401029|NCT01255592|Primary|Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).|||ratio||90% Confidence Interval|Least Squares Mean
1401030|NCT01255449|Secondary|Post-HSCT Changes in Lung Tissue Density|Changes in lung tissue density were measured by quantitative computed tomography(CT) scan 2 weeks before and 2 months after HSCT|Before and 2 months after HSCT|CT scans, in a format suitable for software analysis, were available in 8 patients only|||g/mL||Standard Deviation|Mean
1401031|NCT01255449|Primary|Airway Distensibility With Lung Inflation After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)|We studied 26 subjects, 2 weeks before and 2 months after HSCT. Within-breath respiratory system conductance (Grs) at 5, 11 and 19 Hz was measured by forced oscillation technique (FOT) at functional residual capacity (FRC) and total lung capacity (TLC)|2 weeks before and 2 months after HSCT||||1/cmH2O*s||Standard Deviation|Mean
1401032|NCT01255436|Secondary|Percentage of Patients With Controlled Blood Pressure at the End of 12 Weeks|The percentage of patients with systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg at the end of 12 weeks|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.|||percentage of participants|||Number
1401033|NCT01255436|Secondary|Medication Adherence Rate|The percentage of patients with an improvement of at least one point in adherence score as measured by the Adherence Self-Report Questionnaire at the end of 12 weeks Scale Range: 1 to 6, with 1 being the highest (most adherent) and 6 being the lowest (least adherent)|12 weeks|Only patients who completed follow up and had evaluable data were analyzed.|||percentage of participants|||Number
1401034|NCT01255436|Primary|Mean Absolute Change in Diastolic Blood Pressure After 12 Weeks|Absolute change in diastolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only patients who completed follow up and had evaluable data were analyzed.|||mmHg||Standard Deviation|Mean
1401035|NCT01255436|Primary|Mean Absolute Change in Systolic Blood Pressure After 12 Weeks|Absolute change in systolic blood pressure from baseline to 12 weeks|baseline and 12 weeks|Only participants who completed follow up and had evaluable data were analyzed.|||mmHg||Standard Deviation|Mean
1401036|NCT01255423|Secondary|Ankle Joint Function|"Ankle joint function score (Karlsson Scoring scale which ranges from 0 worst possible score to 90 best possible score)at 24 and 72 hours and 7 days."|24 and 72 hours, 7 days||||Total score||Standard Deviation|Mean
1401037|NCT01255423|Secondary|Tenderness|Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.|Change from baseline at 24 and 72 hours, 7 days||||N/cm^2||Standard Deviation|Mean
1401038|NCT01255423|Secondary|Onset of Pain Relief|Onset of perceptible pain relief|Day 1||||Hour||Inter-Quartile Range|Median
1401039|NCT01255423|Secondary|Pain on Movement|"Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|24 hours and 7 days||||mm||Standard Deviation|Mean
1401040|NCT01255423|Primary|Pain on Movement|"Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain"|72 hours||||mm||Standard Deviation|Mean
1401041|NCT01255306|Secondary|Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade|To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.|6 months|We included all patients who completed follow up visits and who had valid OCT measurements as defined per protocol.|||micrometer|Participants|Standard Deviation|Mean
1401042|NCT01255306|Primary|Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography|Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade.|6 months|We included all patients that have completed necessary follow up visits and have had optical coherence tomography measurements at all visits in the final analysis.|||micrometer|Participants|Standard Deviation|Mean
1401043|NCT01255163|Secondary|Body Mass Index (BMI)|Body Mass Index defined as a person's weight in kilograms (kg) divided by his or her height in meters squared.|18 months||||kg/m^2||Standard Deviation|Mean
1401044|NCT01255163|Secondary|Cerebrospinal Fluid Amyloid-beta 42 (CSF Abeta42)|Abeta42 peptide measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio|18 months||||pg/dl||Standard Deviation|Mean
1401045|NCT01255163|Secondary|Cerebrospinal Fluid phospho181-tau (CSF p181-tau)|p-181-Tau measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio|18 months||||pg/dl||Standard Deviation|Mean
1401046|NCT01255163|Secondary|Cerebrospinal Fluid (CSF) Total Tau|Total Tau measured in CSF using Luminex xMAP technology and INNO-BIA Alz Bio3 kits (Research Use Only) provided by Fujirebio|18 months||||pg/dl||Standard Deviation|Mean
1401047|NCT01255163|Secondary|Clinical Dementia Rating (CDR) Sum of Boxes|"Sum of the Clinical Dementia Rating boxes (memory, orientation, judgment and problem solving, community affairs, home and hobbies, personal care). Each box is rated as 0, 0.5, 1, 2 or 3. Range for the sum of boxes is 0 - 18. Higher scores reflect a greater severity of dementia."|18 months||||units on a scale||Standard Deviation|Mean
1401048|NCT01255163|Secondary|Clinical Dementia Rating (CDR) Global Score|Clinical Dementia Rating global score range: 0 (no dementia); 0.5 (Mild Cognitive Impairment); 1 (mild dementia); 2 (moderate dementia); 3 (severe dementia). Higher is worse.|18 months||||units on a scale||Standard Deviation|Mean
1401049|NCT01255163|Secondary|Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog70)|Alzheimer's dementia scale cognitive sub-scale range: 0 - 70 points (higher is worse)|18 months||||units on a scale||Standard Deviation|Mean
1401050|NCT01255163|Secondary|Mini Mental State Examination (MMSE)|Scale range: 0 - 30 points (higher is better)|18 months||||units on a scale||Standard Deviation|Mean
1401051|NCT01255163|Primary|Number of Participants With Incidence of Nausea|Tolerability of exenatide (nausea is the most common expected adverse event of exenatide)|18 months||||Participants|||Count of Participants
1401052|NCT01255137|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse events module.|3/2/11 - 8/2/12||||Participants|||Number
1401053|NCT01255137|Primary|Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameter. Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: the appearance of one or more new lesions is also considered progression). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum diameters while on study.|2 years||||Participants|||Number
1401054|NCT01254890|Secondary|Phase II: Number of Participants With Response|Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of <5% blasts in the bone marrow (BM), with >1 X 10^9/L neutrophils and >100 x 10^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of >/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.|90 days|Nine participants were not evaluable for response.|||participants|||Number
1401055|NCT01254890|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine|MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine|28 day cycle||||mg/twice daily|||Number
1401056|NCT01254877|Secondary|HIV Medication Adherence|The investigators will obtain patient self reports of the number of HIV medication doses taken as a function of the total number of doses prescribed. The adherence measure is expressed as the % of prescribed doses.|16 weeks||||percentage of prescribed doses||Standard Deviation|Mean
1401057|NCT01254877|Secondary|Alcohol-related Problems|Alcohol-related problems were measured using the Short Inventory of Problems - revised (SIP-R), a self-report inventory of adverse consequences associated with alcohol and drug use. The SIP instructs participants to indicate how often each of 15 consequences has occurred during the past three months (“never,” “once or a few times,” “once or twice a week,” “daily or almost daily”; scored 0-3). Item responses are summed to produce a total score and five subscale scores. Total scores range from 0 - 45.|16 weeks||||units on a scale||Standard Deviation|Mean
1401058|NCT01254877|Secondary|Number of Subjects Who Discontinue Due to Side Effects|The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects.|16 weeks||||Participants|||Count of Participants
1401059|NCT01254877|Secondary|Medication Safety|Medication side-effects and adverse events were measured using the Systematic Assessment for Treatment of Emergent Events (SAFTEE). The SAFTEE contains 25 detailed questions that systematically address 29 body systems. A trained interviewer elicits information about onset, duration, pattern, and judgment of attribution. For the present trial outcome, we report number of events.|16 weeks||||number of events||Standard Deviation|Mean
1401060|NCT01254877|Primary|Number of Days/Week Abstinent From Alcohol|The Time-line Follow-back (Sobell, Sobell, Leo & Cancilla, 1988) is used to obtain this secondary dependent measure. Alcohol use will be assessed biweekly and quantified over the 16-week medication period. Number of days/week abstinent from alcohol is calculated as the number of abstinent days divided by the number of study medication days (adjusted for days in confinement (e.g., hospitalization; jail)) and multiplied by 7.|16 weeks||||days/week abstinent from alcohol||Standard Deviation|Mean
1401061|NCT01254877|Primary|Number of Alcoholic Containing Drinks Per Drinking Day|The Time-line Follow-back (TLFB; Sobell, Sobell, Leo & Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual’s drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period|16 weeks||||Standard alcohol drinks per drinking day||Standard Deviation|Mean
1401062|NCT01254851|Primary|Number of Steps Taken in 24 Hours.|The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.|1 day|The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized.|||Steps||Full Range|Median
1401063|NCT01254760|Secondary|Overall Fit|Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|Day 5, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale|Participants|Standard Deviation|Mean
1401064|NCT01254760|Primary|Overall Vision|Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1401065|NCT01254760|Primary|Handling at Removal|Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1401066|NCT01254760|Primary|End of Day Dryness|End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1401067|NCT01254760|Primary|End of Day Comfort|End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|5 days of wear, lenses replaced daily|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1401068|NCT01254747|Secondary|Overall Satisfaction|Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1401069|NCT01254747|Secondary|Corrected Visual Acuity|Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||logMAR|Participants|Standard Deviation|Mean
1401070|NCT01254747|Secondary|Lens Fit|Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale|Participants|Standard Deviation|Mean
1401071|NCT01254747|Primary|Average Daily Wear Time|Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Hours||Standard Deviation|Mean
1401121|NCT01254409|Primary|Safety and Tolerability|Number of subjects with Dose Limiting Toxicities, Number of Treatment Emergent Serious Adverse Events and Adverse Events|From first dose on Day 1 through Day 57|All subjects who received at least one dose of study treatment|||participants|||Number
1402034|NCT01247064|Secondary|Oxygen Saturation Change||Baseline and 1 hour||||percent||95% Confidence Interval|Mean
1401072|NCT01254747|Primary|Dryness Throughout the Day|Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1401073|NCT01254747|Primary|Overall Handling|Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1401074|NCT01254747|Primary|Vision Quality During the Day|Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1401075|NCT01254747|Primary|Overall Comfort|Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.|4 weeks|Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a scale||Standard Deviation|Mean
1401076|NCT01254721|Primary|The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29|The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.|From Baseline to Day 29||||scores on the scale||Standard Deviation|Mean
1401077|NCT01254721|Secondary|The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)|The Severity of Illness scale (CGI-S) is scored to rate the patient’s current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is “Normal, not at all ill” and a score of 7 indicates that a patient is “Among the most extremely ill patients”.|From Baseline to Day 29||||scores on the scale||Standard Deviation|Mean
1401078|NCT01254669|Secondary|The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.|post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)|1 hour after intervention|The number of participants for analysis was determined based on the total enrolled and who responded to knowledge questions|||units on a scale||Standard Deviation|Mean
1401079|NCT01254669|Primary|The Receipt of the First HPV Vaccination|Receipt of the first HPV vaccination among adolescent daughters of the participants|within 1 month of randomization|The number of participants for analysis was determined based on number of participants enrolled and who answered questions of interest.|||percentage of participants|||Number
1401080|NCT01254656|Secondary|Virology Analysis Participant Accountability From Week 96 Through Study Termination|Virology analysis included virus susceptibility (phenotype and genotype)to a standard panel of approved antiretrovirals as determined by the Monogram Biosciences PhenoSense GT assay. Below analysis table included the following parameters: 1. “protocol-defined treatment failure” was defined as an increase in HIV-1 RNA to detectable levels (≥50 copies/mL) on 2 consecutive measurements, the second measurement taken no more than 14 days after the first measurement); 2. “Treatment failure”: treatment failure (both virologic and non-virologic) was defined as a subject who met the protocol-defined treatment failure criterion or discontinued from the study; 3. “NRTI or NNRTI resistance mutations”: nucleoside reverse transcriptase inhibitor or lersivirine-associated resistance-associated mutations (RAM) based on the International AIDS Society–USA (IAS-USA) RAM guidelines; 4. ‘with result’ meant an analyzed sample returned genotypic result or phenotypic result or both.|Week 96 through study termination|The virology analysis set included only evaluable participants i.e. those having samples with valid genotypic or phenotypic susceptibility testing results and HIV-1 RNA >500 copies/mL. However, samples with observed emergence of resistance-associated mutations and HIV-1 RNA level ≤500 copies/mL or missing HIV-1 RNA level, were also noted.|||Participants|||Number
1401081|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.|||Percentage||Standard Deviation|Mean
1401082|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 192 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 192 weeks from Day 1 of the parent protocol.|192 Weeks from Day 1 of the parent protocol|Analyses included all enrolled participants. Week 192 data are presented, as Week 208 had few participants. For participants who discontinued prematurely, LOCF was used to impute values for post discontinuation visits. Participants who discontinued due to termination of the program were not included in the analysis for the post termination visits.|||cells/uL||Standard Deviation|Mean
1401083|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Percentage) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. LOCF was used to impute missing values.|||Percentage||Standard Deviation|Mean
1401084|NCT01254656|Secondary|Change From Baseline in CD4+ Lymphocyte Counts (Absolute) at 144 Weeks From Day 1 of the Parent Protocol|Participant's immunological status assessed by CD4+ lymphocyte count (absolute and percentage) at 48 weeks (ie, 144 weeks from Day 1 of the parent protocol)|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses. Last observation carried forward (LOCF) was used to impute missing values.|||cells/uL||Standard Deviation|Mean
1401085|NCT01254656|Secondary|Number of Participants With Plasma HIV‑1 RNA Level <50 Copies/mL up to Week 208|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at last visit. Abbott RealTime HIV-1 assay was used to measure the HIV-1 RNA level.|Up to Week 208|Analyses included all enrolled participants. Last visit used the last available visit of each participant. Discontinued from study, lost to follow-up, or missing HIV-1 RNA level data at last visit were considered to have HIV-1 RNA levels >=50 copies/mL. Participants discontinued due to program termination were not considered as discontinuations.|||Participants|||Number
1401086|NCT01254656|Primary|Number of Participants With Plasma Human Immunodeficiency Virus - 1 (HIV‑1) Ribonucleic Acid (RNA) Level <50 Copies/mL at 144 Weeks From Day 1 of the Parent Protocol|Number of participants with HIV-1 RNA level <50 copies/mL plasma was summarized at 48 weeks i.e. 144 weeks from Day 1 of the parent protocol. Roche Amplicor HIV-1 Monitor assay was used to measure the HIV-1 RNA level.|144 Weeks from Day 1 of the parent protocol|All participants enrolled in this protocol constituted the analysis population associated with each of the parent protocols and all available data were used for efficacy analyses.|||Participants|||Number
1401087|NCT01254643|Secondary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.|||milli Merck units/mL||95% Confidence Interval|Geometric Mean
1401088|NCT01254643|Primary|Percentage of Participants With a Vaccine-related AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” to the study drug is defined as a vaccine-related AE.|up to 15 days after any vaccination|Safety Population, which consists of all participants who received at least one vaccination and had available follow-up data.|||Percentage of Participants|||Number
1401089|NCT01254643|Primary|Percentage of Participants With a Non-Injection Site (Systemic) AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.|||Percentage of Participants|||Number
1401090|NCT01254643|Primary|Percentage of Participants With an Injection-site Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.|||Percentage of Participants|||Number
1401091|NCT01254643|Primary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.|||Percentage of Participants||95% Confidence Interval|Number
1401092|NCT01254630|Other Pre-specified|Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to approximately 118 days)|The analysis population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis|||percentage of participants|||Number
1401122|NCT01254396|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||hrs||Standard Deviation|Mean
1401093|NCT01254630|Secondary|Incidence of Postherpetic Neuralgia|Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.|Up to 6 months after onset of HZ (up to approximately 5 years)|This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1401094|NCT01254630|Secondary|Incidence of Herpes-Zoster Complications|The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.|Up to 6 months after onset of HZ (up to approximately 5 years)|This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1401095|NCT01254630|Secondary|Incidence of Moderate to Severe Herpes-Zoster-Associated Pain|Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score of 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.|Up to 6 months after onset of HZ (up to approximately 5 years)|This analysis was based on the MITT population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1401096|NCT01254630|Primary|Percentage of Participants With One or More Serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to approximately 118 days)|The analysis population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. Three participants in the STM population were cross-treated, these participants were excluded from the safety analyses. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis|||percentage of participants||95% Confidence Interval|Number
1401097|NCT01254630|Primary|Incidence of Confirmed Herpes-Zoster|Clinical criteria for suspected HZ cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.|Up to approximately 5 years|This analysis was based on the Modified Intent-to-Treat (MITT) population. The MITT population for this outcome measure included all randomized participants in the STM population who received at least one dose of vaccination. This endpoint was exploratory for the HM population, therefore that group was not included in this analysis.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1401098|NCT01254604|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE are counted once in this summary.|Up to Week 4|APaT population|||participants|||Number
1401099|NCT01254604|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with one or more AEs during the study are counted once in this summary.|Up to 14 days after Week 4 visit|APaT population|||participants|||Number
1401100|NCT01254604|Secondary|Number of Participants With ≥25% Reduction in IOP From Baseline to Week 4 - Study Eye|IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one “study eye” was identified for data summarization and analysis. The “study eye” was the eye with the higher (i.e., “worse”) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the “study eye.” Percent reduction in IOP at Week 4 = ([baseline IOP value − Week 4 IOP value]/Baseline IOP value)*100.|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint|||participants|||Number
1401123|NCT01254396|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours (hrs) post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1401101|NCT01254604|Primary|Mean Diurnal IOP Change From Baseline at Week 4 - Study Eye|IOP was measured at baseline, Week 2 and Week 4 using a Goldmann applanation tonometer. At each of these visits, IOP measurement was performed at 0800, 1000 and 1600 hours. At each IOP assessment time point during a visit, 2 consecutive IOP measurements were made. If these 2 measurements differed by ≤2 mmHg, then the average of the 2 IOP values was recorded. If the 2 measurements differed by >2 mmHg, then a third measurement was obtained and the median of these 3 measurements was recorded. The IOP value for a visit (e.g., Week 4) was the mean of the values recorded at the 3 time points during the visit. For each participant, one “study eye” was identified for data summarization and analysis for this primary efficacy outcome measure. The “study eye” was the eye with the higher (i.e., “worse”) IOP at baseline, or if both eyes had the same baseline IOP value, the right eye was designated the “study eye.” Change from baseline in IOP at Week 4 = Week 4 IOP value − baseline IOP value.|Baseline and Week 4|Per Protocol population: Participants who received at least one dose of study drug, had at least one efficacy measurement available for an analysis endpoint and did not have any protocol violations that may substantially affect the results of the primary efficacy endpoint|||mmHg||95% Confidence Interval|Least Squares Mean
1401102|NCT01254565|Secondary|Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase||Efficacy assessment phase|Modified intent to treat population|||percentage of participants|||Number
1401103|NCT01254565|Secondary|Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.|||percent change||Standard Deviation|Mean
1401104|NCT01254565|Secondary|Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.|||percent change||Standard Deviation|Mean
1401105|NCT01254565|Secondary|Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population with available data|||percent change||Standard Deviation|Mean
1401106|NCT01254565|Secondary|Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population|||percentage of participants|||Number
1401107|NCT01254565|Secondary|Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population|||percentage of participants|||Number
1401108|NCT01254565|Primary|Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase|Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.|Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
1401109|NCT01254409|Secondary|SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline|St. George's Respiratory Questionnaire Total Score. Scores range from 0 (no impairment) to 100 (maximum impairment). A decrease in score represents a decrease in disease related symptoms. The SGRQ is not validated for IPF.|Day 1 (Baseline) and Day 57||||units on a scale||Standard Deviation|Mean
1401110|NCT01254409|Secondary|6MWT (6 Minute Walk Test) Distance Walked Change From Baseline|Change from baseline (measured during screening period) in distance walked during a 6 minute walk test|Screening (between Day -35 and Day 1) and Day 57||||meters||Standard Deviation|Mean
1401111|NCT01254409|Secondary|FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline||Day 1 (Baseline) and Day 57||||Absolute change in FEV1 % predicted||Standard Deviation|Mean
1401112|NCT01254409|Secondary|DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline||Day 1 (Baseline) and Day 57||||Absolute change in % predicted DLCO||Standard Deviation|Mean
1401113|NCT01254409|Secondary|FVC (Forced Vital Capacity) % Predicted Change From Baseline||Day 1 (Baseline) and Day 57||||absolute change in % predicted FVC||Standard Deviation|Mean
1401114|NCT01254409|Secondary|FVC (Forced Vital Capacity) Change From Baseline to Day 57||Change from Day 1 (Baseline) to Day 57||||liters||Standard Deviation|Mean
1401115|NCT01254409|Secondary|Vss|Volume of Distribution at Steady State|Day 15||||mL/kg||Full Range|Mean
1401116|NCT01254409|Secondary|Total Body Clearance||Day 15||||ml/hr/kg||Full Range|Mean
1401124|NCT01254396|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
1401125|NCT01254396|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.|||hrs||Full Range|Median
1401126|NCT01254396|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hrs post-dose|Pharmacokinetic parameter analysis population included all randomized and treated participants who had at least 1 of the pharmacokinetic parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1401127|NCT01254344|Secondary|Percentage of Participants With Favorable Clinical Response|Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection|4 weeks posttreatment|Population analyzed was participants who had no signs or symptoms of infection at the surgical site and did not require surgical intervention for infection.|||percentage of participants||95% Confidence Interval|Number
1401128|NCT01254344|Primary|Percentage of Participants With Success of Prophylaxis|Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy|From study drug dose (day of surgery) up to 4 weeks post therapy|"Primary analysis results are for evaluable-patients-only, defined as patients who received a complete dose of prophylaxis, underwent elective colorectal surgery with completion of bowel preparation procedure, had primary skin closure of the wound, and did not receive any prohibited systemic antibiotics or other prohibited anti-infective agents."|||percentage of participants||95% Confidence Interval|Number
1401129|NCT01254331|Secondary|Number of Participants Who Discontinued Tocilizumab||Week 52|Safety population|||participants|||Number
1401130|NCT01254331|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death||Baseline, every 4 weeks through Week 52|Safety population|||percentage of participants|||Number
1401131|NCT01254331|Secondary|Percentage of Participants Experiencing Fatigue||Baseline and Weeks 4, 8, 12, 16, 20, and 24|Safety population; n=number of participants analyzed for the given parameter at the specified visit|||percentage of participants|||Number
1401132|NCT01254331|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Levels|ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm/hour||95% Confidence Interval|Mean
1401133|NCT01254331|Secondary|Mean C-Reactive Protein (CRP) Levels|CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L).|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mg/L||95% Confidence Interval|Mean
1401134|NCT01254331|Secondary|Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)|Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||units on a scale||95% Confidence Interval|Mean
1401135|NCT01254331|Secondary|Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm||95% Confidence Interval|Mean
1401136|NCT01254331|Secondary|Assessment of Global Disease by the Participant Using VAS|"The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm||95% Confidence Interval|Mean
1401137|NCT01254331|Secondary|Assessment of Pain by the Participant Using Visual Analog Scale (VAS)|"The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to their level of pain and the distance from the left edge was measured."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||mm||95% Confidence Interval|Mean
1401138|NCT01254331|Secondary|SJC and TJC|28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants assessed for the given parameter at the specified timepoint.|||joints||95% Confidence Interval|Mean
1401139|NCT01254331|Secondary|Time To Achieve ACR20/ACR50/ACR70|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population|||weeks||Inter-Quartile Range|Median
1401140|NCT01254331|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)|The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population|||percentage of participants|||Number
1401141|NCT01254331|Secondary|Percentage of Participants Achieving Remission Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit|||percentage of participants|||Number
1401142|NCT01254331|Secondary|Percentage of Participants Achieving LDA Assessed Using DAS28|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; n=number of participants analyzed at a specific visit|||percentage of participants|||Number
1401143|NCT01254331|Secondary|Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)|DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤) 3.2 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement.|Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52|Safety population; number (n)= number of participants analyzed at a specific visit|||percentage of participants|||Number
1401144|NCT01254318|Secondary|Percentage of Participants With Invasive Fungal Infections in Canada|Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.||||||
1401145|NCT01254318|Secondary|Percentage of Participants With a Specific Fungal Pathogen at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.|365 days|All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.|||Percentage of participants|||Number
1401146|NCT01254318|Primary|Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution|Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.|365 days|All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.|||Percentage of participants||95% Confidence Interval|Number
1401147|NCT01254305|Primary|Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score|The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient’s current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.~The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."|||units on a scale||Standard Deviation|Mean
1401148|NCT01254305|Secondary|Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward|The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems—with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).|From Baseline to Week 8|The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.|||units on a scale||Standard Deviation|Mean
1401206|NCT01253811|Secondary|Vital Signs: Diastolic BP (Blood Pressure)|Values collected for diastolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set one dose of the trial product.|||mmHg||Standard Deviation|Mean
1402035|NCT01247064|Secondary|Respiratory Rate Change||Baseline and 1 hour||||breaths per minute||95% Confidence Interval|Mean
1401149|NCT01254305|Primary|Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score|The CGI-S is a clinician-rated scale that rates the severity of the patient’s current state of fatigue based on the Investigator’s clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued|From Baseline to Week 8|"The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.~The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score."|||units on a scale||Standard Deviation|Mean
1401150|NCT01254292|Secondary|User Satisfaction – Acceptability of the Administration of Study Treatment|The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.|At 12 months|Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 12 months)|||Participants|||Number
1401151|NCT01254292|Secondary|User Satisfaction – Acceptability of the Administration of Study Treatment|The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.|At 6 months|Full analysis set (only subjects with an assessment of these questions of the user satisfaction questionnaire at 6 months)|||Participants|||Number
1401152|NCT01254292|Other Pre-specified|Participants’ Evaluation of Pain During IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)|||Participants|||Number
1401153|NCT01254292|Other Pre-specified|Investigator's Evaluation of IUS Removal Procedure||Up to 36 months|Full analysis set (only subjects in the LCS12 arm with documented removal of the IUS)|||Participants|||Number
1401154|NCT01254292|Other Pre-specified|Participants’ Evaluation of Pain During Successful IUS Insertion Procedure||Up to 18 months|Full analysis set|||Participants|||Number
1401155|NCT01254292|Other Pre-specified|Investigator's Evaluation of Successful IUS Insertion Procedure||Up to 18 months|Full analysis set|||Participants|||Number
1401156|NCT01254292|Other Pre-specified|Cumulative Number of Participants With Partial or Total Expulsion|Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.|Up to 18, 24, 36 months|Full analysis set|||Participants|||Number
1401157|NCT01254292|Secondary|Compliance Rate for Yasmin Pill Intake||Up to 18 months|Full analysis set|||Percentage of participants|||Number
1401158|NCT01254292|Secondary|Pearl Index (PI)|The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.|Up to 18, 24, 36 months|Full analysis set|||Pregnancies per 100 women years||95% Confidence Interval|Mean
1401159|NCT01254292|Secondary|Cumulative Drop-out Rate|The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.|Up to 6, 12, 18, 24 and 36 months|Full analysis set|||Percentage of participants|||Number
1401160|NCT01254292|Secondary|EVAPIL-R Scores at 18 Months/EOS|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 18 months/end of study where the scores could be calculated)|||Scores on a scale||Standard Deviation|Mean
1401161|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the composite score could be calculated)|||Scores on a scale||Standard Deviation|Mean
1401162|NCT01254292|Secondary|EVAPIL-R Scores at 12 Months - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 12 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 12 months where the bother score could be calculated)|||Scores on a scale||Standard Deviation|Mean
1401207|NCT01253811|Secondary|Vital Signs: Systolic BP (Blood Pressure)|Values collected for systolic BP from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmHg||Standard Deviation|Mean
1401163|NCT01254292|Secondary|EVAPIL-R Scores at 6 Months|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At 6 months|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at 6 months where the scores could be calculated)|||Scores on a scale||Standard Deviation|Mean
1401164|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Bother Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the bother score could be calculated)|||Scores on a scale||Standard Deviation|Mean
1401165|NCT01254292|Secondary|EVAPIL-R Scores at Screening - Composite Score|The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.|At screening|Full analysis set (only subjects with an assessment of the EVAPIL questionnaire at screening where the composite score could be calculated)|||Scores on a scale||Standard Deviation|Mean
1401166|NCT01254292|Secondary|User Satisfaction – Rating of Usual Menstrual Pain Intensity|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401167|NCT01254292|Secondary|User Satisfaction – Comparison of Menstrual Pain Intensity Between Now and Before Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401168|NCT01254292|Secondary|User Satisfaction – Satisfaction With Menstrual Bleeding Absence|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401169|NCT01254292|Secondary|User Satisfaction – Frequency of Experiencing Unexpected Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401170|NCT01254292|Secondary|User Satisfaction – Satisfaction With Menstrual Bleeding Pattern|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401171|NCT01254292|Secondary|User Satisfaction – Amount of Menstrual Bleeding|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401172|NCT01254292|Secondary|User Satisfaction – Choices Upon Completion of the Study|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401173|NCT01254292|Secondary|User Satisfaction – Acceptability of the Administration of Study Treatment|The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.|At 18 months/EOS|Full analysis set (only subjects with an assessment of this questions of the user satisfaction questionnaire at 18 months/end of study)|||Participants|||Number
1401174|NCT01254292|Secondary|Overall Satisfaction Rate at 12 Months (LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)|||Percentage of participants|||Number
1401175|NCT01254292|Secondary|Overall Satisfaction Rate at 6 Months (LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months or before)|||Percentage of participants|||Number
1402036|NCT01247064|Secondary|Rate of Hospitalization||1 day||||percentage of participants|||Number
1403387|NCT01235338|Primary|Cmax of Venlafaxine Hydrochloride|Venlafaxine Hydrochloride is the active ingredient of Effexor XR|Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
1401176|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)|"Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.~The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase."|At 18 months/EOS|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months/end of study)|||Percentage of participants|||Number
1401177|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 18 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 18 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 18 months)|||Percentage of participants|||Number
1401178|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 12 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 12 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 12 months)|||Percentage of participants|||Number
1401179|NCT01254292|Secondary|Overall Satisfaction Rating by the 5-point Likert Item at 6 Months|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 6 months|Full analysis set (only subjects with an assessment of overall satisfaction rating at 6 months)|||Percentage of participants|||Number
1401180|NCT01254292|Primary|Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)|Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting “1. Very satisfied” or “2. Satisfied” for the above question.|At 18 months|Full analysis set (only subjects with at least one assessment of the overall satisfaction rating)|||Percentage of participants|||Number
1401181|NCT01254214|Secondary|Center for Epidemiologic Studies Depression Scale (CESD)|The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.|baseline, 8 weeks, 26 weeks||||units on a scale||Standard Deviation|Mean
1401182|NCT01254214|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.|baseline, 8 weeks, 26 weeks||||units on a scale||Standard Deviation|Mean
1401183|NCT01254214|Secondary|SF-12 PCS|Physical component summary score (PCS) of the SF-12 is a self-reported measure of physical health-related quality of life.Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired physical health quality or function.|baseline, 8 weeks, 26 weeks||||T scores||Standard Deviation|Mean
1401184|NCT01254214|Secondary|Short Form -12 MCS|Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.|baseline, 8 and 26 weeks||||T-Scores||Standard Deviation|Mean
1401185|NCT01254214|Primary|State-Trait Anxiety Inventory|The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.|Baseline, 8 weeks, 26 weeks||||units on a scale||Standard Deviation|Mean
1401186|NCT01254188|Secondary|Kaplan-Meier Estimates of Failure-free Survival|Time to event (months) = (date of event or censoring – date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.|3,6,9,12,15,18,21,and 24 months|FAS|||percentage probability||95% Confidence Interval|Number
1401187|NCT01254188|Secondary|Kaplan-Meier Estimates of Progression-free Survival|PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.|3,6,9,12,15,18,21,and 24 months|FAS|||percentage probability||95% Confidence Interval|Number
1401188|NCT01254188|Secondary|Overall Survival|OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|3, 6, 9, 12, 15, 18, 21, 24 Months||||percentage probability||95% Confidence Interval|Number
1401189|NCT01254188|Secondary|Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.|"* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics.~Duration of first CCyR (months) = (date of CCyR loss or censoring – date of first CCyR +1) / 30.4375"|6,12,18 and 24 months||||percentage of participants||95% Confidence Interval|Number
1401190|NCT01254188|Secondary|Complete Cytogenetic Response|Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.|6 months||||percentage of participants||95% Confidence Interval|Number
1401191|NCT01254188|Secondary|Duration of Major Molecular Response|Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) – date of first MMR + 1) / 30.4375|3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected|Full Analysis set, Number of events / censored 29/312.|||percentage of participants||95% Confidence Interval|Number
1401192|NCT01254188|Secondary|Time to Molecular Response at 24 Months|Estimated median time to first MMR by Kaplan-Meier method|24 months|Full analysis set|||Months||95% Confidence Interval|Median
1401193|NCT01254188|Primary|The Percentage of Patients Achieving MMR by 12 Months|MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method|12 months||||percentage of participants||95% Confidence Interval|Number
1401194|NCT01254045|Secondary|Salivary Cortisol|salivary cortisol level measured immediately before social challenge task and 20 minutes following social challenge task at each time point (i.e., baseline, week 2, and week 3)|baseline, week 2, and week 3||||nmol/L||Standard Error|Mean
1401195|NCT01254045|Primary|Eye Contact/Gaze During 10 Minute Social Challenge Task|Number of times that eye gaze occurred (i.e., participant looked at female experimenter in the eyes) during 10 minute social challenge task (first 5 minutes social proximity, second 5 minutes social interaction). The social challenge task occurred 50 minutes after internasal dose (of placebo, placebo + oxytocin, or oxytocin) at baseline, week 2, and week 3 visits.|baseline, week 2, and week 3||||eye contact/gaze events per 10 minutes||Standard Error|Mean
1401196|NCT01253980|Primary|Treatment Failure|A treatment failure was a patient who at any time deteriorated necessitating a change to the treatment regimen. This was determined by assessing reported symptoms (cough, shortness of breath, wheeze and fever) and comparing clinical signs (respiratory rate, oxygen saturation, wheeze, flaring, grunting, recessions, crepitations, temperature, mental status) to signs at presentation.|At routine follow-up 3 and 5 days post-ingestion or earlier if necessary|per protocol|||participants||95% Confidence Interval|Number
1401197|NCT01253902|Secondary|Mean Tear Break Up Time (TBUT) at Week 12|Tear Break Up Time was analyzed using the average of the readings of both eyes. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.|||Seconds||Standard Deviation|Mean
1401198|NCT01253902|Secondary|Mean Corneal Staining With Fluorescein at Week 12|Corneal staining was analyzed using the average of the scores of both eyes. The cornea is the transparent front part of the eye which covers the iris and pupil. To detect the presence or absence of corneal puncta (tiny disruptions in the surface of the eye), fluorescein dye is administered into the eye and the eye is graded using a 5-point scale where 0=None (no puncta), 0.5=Trace (1-5 puncta), 1=Mild (6-20 puncta), 2=Moderate (>20 puncta) and 3=Severe (too many puncta to count).|Week 12|Intent-to-treat (ITT) population included all participants who were randomized and received study medication.|||Score on a scale||Standard Deviation|Mean
1401199|NCT01253902|Primary|Mean Conjunctival Hyperemia at Week 12|Conjunctival hyperemia was analyzed using the average of the scores of both eyes. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).|Week 12|Intent-to-treat population (ITT) included all participants who were randomized to study medication.|||Score on a scale||Standard Deviation|Mean
1401200|NCT01253824|Secondary|Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||mIU･day/mL||Standard Deviation|Mean
1401201|NCT01253824|Primary|Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||ng･day/mL||Standard Deviation|Mean
1401202|NCT01253824|Secondary|Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||mIU･day/mL||Standard Deviation|Mean
1401203|NCT01253824|Primary|Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA))|Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data|Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles||||pg･day/mL,||Standard Deviation|Mean
1401204|NCT01253811|Secondary|Rate (Number Per Subject Year) of All Bleeding Episodes Requiring Treatment With a FXIII Containing Product Other Than Recombinant Factor XIII.|The rate (number per subject year) of all spontaneous, traumatic and intracranial bleeding episodes requiring treatment with FXIII-containing products during the rFXIII treatment period was assessed for treatment period.|Weeks 0 to end of trial visit (week 173).|There were no bleeding episodes requiring treatment with a haemostatic agent (rFXIII) during the trial, which included subjects from full analysis set who received at least one dose of the trial product.||||||
1401205|NCT01253811|Secondary|Vital Signs: Pulse|Values collected for pulse from week 0 to end of trial visit.|Week 0 to end of trial visit (week 173).|The safety analysis included all subjects who received at least one dose of the trial product.|||beats/minute||Standard Deviation|Mean
1401208|NCT01253811|Secondary|Physical Examinations|Number of subjects in percentage with changes in values of physical examinations from week 0 to end of trial visit were collected.|Week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product. Two abnormal physical examination findings related to skin and musculo-skeletal system were assessed as clinically significant by the investigator during the trial.|||percentage of subjects|||Number
1401209|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haematocrit|Clinical laboratory values for haematocrit collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||percentage of red blood cells||Standard Deviation|Mean
1401210|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Erythrocytes|Clinical laboratory values for erythrocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||10^12 cells/L||Standard Deviation|Mean
1401211|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Thrombocytes|Clinical laboratory values for thrombocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||10^9 cells/L||Standard Deviation|Mean
1401212|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Leucocytes|Clinical laboratory values for leucocytes collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||10^9 cells/L||Standard Deviation|Mean
1401213|NCT01253811|Secondary|Clinical Laboratory Assessments: Haematology: Haemoglobin|Clinical values for haemoglobin collected from week 0 to end of trial visit.|Every 6th month, from week 0 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmol/L||Standard Deviation|Mean
1401214|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Aspartate Aminotransferase (ASAT)|Clinical laboratory assessments for ASAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||IU/L||Standard Deviation|Mean
1401215|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Alanine Aminotransferase (ALAT)|Clinical laboratory assessments for ALAT at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||IU/L||Standard Deviation|Mean
1401216|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Urea|Clinical laboratory assessments for urea at week 24 to end ot trial visit.|Every 6th month, week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmol/L||Standard Deviation|Mean
1401217|NCT01253811|Secondary|Clinical Laboratory Assessments: Biochemistry: Creatinine|Clinical laboratory assessments for creatinine at week 24 to end of trial visit.|Every 6th month, from week 24 to end of trial visit (week 173).|The safety analysis set included all subjects who received at least one dose of the trial product.|||mmol/L||Standard Deviation|Mean
1401218|NCT01253811|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors.|All subjects who received rFXIII were monitored for the frequency of development of anti-rFXIII antibodies. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors.|Week 0 to end of trial visit (week 173).|The SAS included all subjects who received at least one dose of the trial product. There were no antibodies against rFXIII detected in any patient during the trial.|||percentage of subjects|||Number
1401219|NCT01253811|Primary|Number of Treatment Emergent (Serious and Non-serious) Adverse Events|An adverse event was described as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (serious and non-serious), defined as adverse events occurring from first trial product administration to the end of the subject’s participation in the trial.|Week 0 to end of trial visit (week 173) for a minimum period of 52 weeks.|The safety analysis set included all subjects who received at least one dose of the trial product.|||number of events|||Number
1401220|NCT01253642|Other Pre-specified|Frequency of LSD-1 (Lysine-specific Histone Demethylase 1) Expression|Outcome measure will be reported using descriptive statistics, after overall study completion (March 2019).|Up to 6 years||2019-03-31|03/2019||||
1401221|NCT01253642|Other Pre-specified|Frequency of Gene Expression|Outcome measure will be reported using descriptive statistics, after overall study completion (March 2019).|Up to 6 years||2019-03-31|03/2019||||
1401222|NCT01253642|Secondary|Toxicity of the Regimen|Number of participants who experienced an Adverse Event. Detail of Adverse Events is reported in the Adverse Event Section|Up to 6 years||||Participants|||Count of Participants
1401223|NCT01253642|Secondary|Time to Death From All Causes|Time to death is calculated from Day 1 of Combination therapy to death from any cause.|Up to 6 years||||days||Full Range|Median
1401224|NCT01253642|Secondary|Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria|Response in measurable disease is defined as a 30% decrease in the sum of diameters of target lesions (as described by RECIST 1.1).|Up to 6 years|3 subjects were excluded from this response rate calculation as they did not have additional scans beyond baseline.|||Participants|||Count of Participants
1401225|NCT01253642|Secondary|Maximum Change in PSA|Measured from Day 1 of Combination therapy to PSA at 12 Weeks on therapy (or earlier if subject not on therapy for 12 weeks).|12 weeks (or earlier in patients who discontinued early)|1 subject withdrew from the study before reaching 12 weeks and is not included in this progression free survival analysis.|||percentage of PSA change||Full Range|Median
1402839|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 12 weeks|||||||
1401226|NCT01253642|Secondary|MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression|A Pearson's correlation will be used to correlate tumor biopsy MAOA expression and circulating tumor cells MAOA expression.|Up to 6 years|Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.||||||
1401227|NCT01253642|Secondary|HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity||Up to 6 years|Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.||||||
1401228|NCT01253642|Secondary|Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel|Reported as Number of participants with MAOA expression greater than 5%.|Baseline|Subjects who had evaluable samples collected immediately prior to initiation of Combination Therapy. 3 subjects did not have evaluable samples and were not included in this analysis.|||Participants|||Count of Participants
1401229|NCT01253642|Secondary|Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy|Progression free survival is calculated as the time from Day 1 of Combination therapy to first evidence of progression (by PSA, Measureable Disease, or Clinical Progression). For subjects who did not meet progression criteria, date of new therapy or date of death was used. Outcome is reported as mean.|Up to 6 years|1 subject withdrew from the study before the first evidence of progression and is not included in this progression free survival analysis.|||days||Full Range|Mean
1401230|NCT01253642|Primary|Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%|PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).|Within 12 weeks||||Participants|||Count of Participants
1401231|NCT01253577|Secondary|Percentage of Sinuses That Developed Frank Polyposis|Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30 days|All 105 subjects were present for this endpoint exam. However n=85 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.|||percentage of sinuses||95% Confidence Interval|Mean
1401232|NCT01253577|Primary|Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure|clinically significant IOP elevation is a change from baseline of >10 mm Hg on sinus side with drug-coated implant but not on side with control implant|90 days|Two patients did not have their ocular exam performed at day 90 (LTFU) but had ocular exams at earlier time points.|||percentage of patients||95% Confidence Interval|Mean
1401233|NCT01253577|Primary|Percentage of Sinuses Requiring Post-operative Intervention|Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.|30-days|All 105 subjects were present for the primary endpoint exam. However n=96 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.|||percentage of sinuses||95% Confidence Interval|Mean
1401234|NCT01253564|Secondary|Percentage of Participants With Improvement in Physician's Assessment of Global Performance Status|Physician’s Assessment of Global Performance Status was assessed on 7 point scale (1- Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, 7- Very much worse). An improvement was classed as a difference from baseline of at least -1 point. Percentage of participants with 95% Clopper-Pearson CI were reported for participants with improvement in Physician's Assessment of Global Performance Status at any visit.|Baseline, Day 1 of every 28-day cycle, at end of study and at the 28-day follow-up visit (up to 16 months)|Safety population.|||percentage of participants||95% Confidence Interval|Number
1401235|NCT01253564|Secondary|Percentage of Participants With Improvement in Visual Analog Scale (VAS) Assessment of Pain|VAS is a measure of pain intensity. The participant was asked to mark on a 100 mm line where their pain level was on the day they completed the scale. The beginning of the line represented no pain and the end of the line represented maximum pain. Total score ranged from 0 - 100. Reported values are decrease in VAS of greater than (>) 20 mm or >30 mm from baseline.|Baseline; Day 1 of Cycles 2-8 (28-day cycle) and at the end of study visit (up to 16 months)|Safety population. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
1401236|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Narcotic Pain Analgesic|An improvement in narcotic pain analgesics was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population|||percentage of participants|||Number
1401237|NCT01253564|Secondary|Percentage of Participants With Improvement in Total Daily Dose of Corticosteroids|An improvement in corticosteroid dose was defined as a dose reduction of at least 33% of baseline dose for at least 28 days or stopping use completely. Percentage of participants and 95% Clopper-Pearson CI are reported.|Baseline, every week during the first 8 weeks and every second week thereafter up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.|||percentage of participants||95% Confidence Interval|Number
1401238|NCT01253564|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. Participants who discontinued the study treatment for any reason other than withdrawal of consent were continued to be followed for survival. The end of study occurred when all participants had been followed for a period of 6 months, had died, withdrawn consent or were lost to follow-up, whichever occurred first. OS was calculated by Kaplan-Meier estimates.|From start of treatment up to end of the study and every 3 months during follow up (up to 16 months)|Safety population.|||months||95% Confidence Interval|Median
1401239|NCT01253564|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason are reported.|Baseline up to end of the study and every 3 months during follow-up (up to 16 months)|Safety Population.|||percentage of participants|||Number
1401266|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 1|AUC from time 0 to infinity (0-∞) after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC0-∞ values.|||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
1401240|NCT01253564|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.|||months||95% Confidence Interval|Median
1401241|NCT01253564|Secondary|Percentage of Participants With Disease Progression or Death by Disease Site|Disease progression (according to RECIST version 1.1) was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Percentage of participants with disease progression by brain, other sites (extracranial) and whole body are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population.|||percentage of participants|||Number
1401242|NCT01253564|Secondary|Time to New Lesion by Disease Site|Time to new lesions was defined as the interval between the date of first treatment and the date of first documentation of new lesions. Time to new lesion was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every eighth week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, ‘n’ signifies number of participants with measurable disease at baseline for specified category.|||months||95% Confidence Interval|Median
1401243|NCT01253564|Secondary|Duration of Stable Disease (SD) by Disease Site|Duration of SD was defined as the time between the first documented date of SD and date of PD or death from any cause. SD was defined (according to RECIST version 1.1) as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Duration of SD was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety Population. Here, 'n' signifies number of participants with measurable disease at baseline for specified category.|||months||95% Confidence Interval|Median
1401244|NCT01253564|Secondary|Time to Response by Disease Site|Time to response was defined as the interval between the date of first treatment and the date of first documentation of CR or PR (whichever occurred first). CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Time of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies number of participants with measurable disease for specified category.|||months||95% Confidence Interval|Median
1401245|NCT01253564|Secondary|Duration of Response by Disease Site|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death, only for those participants whose best overall response was CR or PR. CR and PR were assessed by investigator according to RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions. Duration of response was calculated by Kaplan-Meier estimates separately for brain, other sites (extracranial) and whole body.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease or death (up to 16 months)|Safety population. Here, 'n' signifies number of participants with best overall response of CR or PR for specified category.|||months||95% Confidence Interval|Median
1401246|NCT01253564|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) by Disease Site|Objective response was assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) (Version 1.1). CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Best overall response was calculated separately for brain, other sites (extracranial) and whole body. Percentage of participants with 95 percent (%) Clopper-Pearson confidence interval (CI) are reported.|Baseline, Week 4, Week 8 and thereafter every 8th week until progressive disease, unacceptable toxicity, consent withdrawal, death or other reasons deemed by the investigator (up to 16 months)|Safety population. Here, 'n' signifies the number of participants with measurable disease at baseline for specified category.|||percentage of participants||95% Confidence Interval|Number
1401267|NCT01253525|Secondary|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The percentage of participants who were treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies.|Cycle 1 through Cycle 5 (28-day cycles)|All enrolled participants who received at least 1 dose of study drug and were analyzed for anti-ramucirumab (IMC-1121B) antibodies.|||percentage of participants|||Number
1401247|NCT01253564|Primary|Percentage of Participants With Adverse Events (AEs)|AE:any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Grade-1:discomfort but no disruption of normal daily activity. Grade-2:discomfort sufficient to reduce or affect daily activity,no intervention indicated.Grade-3:inability to perform normal daily activity,intervention indicated.Grade-4:immediate threat to life or leading to permanent mental or physical condition that prevented performing normal daily activities.Grade 5: death. Any AE included participants with serious and non-serious AE.|From baseline up to last dose (0.1 to 11.3 months) plus 28 days|Safety Population.|||percentage of participants|||Number
1401248|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 4|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401249|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 4|Due to sparse pharmacokinetic sampling CL for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401250|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 4|Due to sparse pharmacokinetic sampling t1/2 for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401251|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 4|Due to sparse pharmacokinetic sampling AUC within the dosing interval (0-τ) for ramucirumab (IMC-1121B) could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401252|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 4|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 4.|Cycle 4: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401253|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 3|Due to sparse pharmacokinetic sampling Vss for ramucirumab (IMC-1121B) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401254|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 3|Due to sparse pharmacokinetic sampling CL could not be calculated for ramucirumab (IMC-1121B) in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401255|NCT01253525|Secondary|Ramucirumab Half-Life (t 1/2) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) t1/2 could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401256|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 3|Due to the sparse pharmacokinetic sampling ramucirumab (IMC-1121B) AUC within the dosing interval (0-τ) could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401257|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 3|Due to sparse pharmacokinetic sampling ramucirumab (IMC-1121B) Cmax could not be calculated in Cycle 3.|Cycle 3: Pre-infusion, Day 1 of 28-day cycle|Zero participants were analyzed.||||||
1401258|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 2|Vss [distribution of ramucirumab (IMC-1121B) in in the body at steady state] is not calculated for multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|Zero participants were analyzed.||||||
1401259|NCT01253525|Secondary|Ramucirumab Clearance (CL) for Cycle 2|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] at steady state after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.|||liters/hour (L/h)||Standard Deviation|Mean
1401260|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 2|Terminal t1/2 [the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%] after multiple doses of ramucirumab(IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.|||hours (h)||Full Range|Median
1401261|NCT01253525|Secondary|Ramucirumab Area Under the Concentration Time Curve (AUC) for Cycle 2|AUC within the dosing interval (0-τ) after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable AUC 0-τ values.|||micrograms*hour/milliliter (µg*h/mL)||Standard Deviation|Mean
1401262|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 2|Cmax after multiple doses of ramucirumab (IMC-1121B).|Cycle 2: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.|||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
1401263|NCT01253525|Secondary|Ramucirumab Steady State Volume of Distribution (Vss) for Cycle 1|Vss [distribution of ramucirumab (IMC-1121B) in the body at steady state] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Vss values.|||liters (L)||Standard Error|Mean
1401264|NCT01253525|Secondary|Ramucirumab Clearance (CL) or Cycle 1|CL [the volume of plasma or serum cleared of ramucirumab (IMC-1121B) per unit time] after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable CL values.|||liters/hour (L/h)||Standard Deviation|Mean
1401265|NCT01253525|Secondary|Ramucirumab Half-Life (t1/2) for Cycle 1|Terminal t1/2 (the time it takes for the concentration of ramucirumab (IMC-1121B) in plasma or serum to decline by 50%) after a single dose of ramucirumab (IMC-1121B).|Cycle 1: Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable t1/2 values.|||hours (h)||Full Range|Median
1401268|NCT01253525|Secondary|Ramucirumab Maximum Serum Concentration (Cmax) for Cycle 1|Cmax after a single dose of ramucirumab (IMC-1121B).|Cycle 1 Pre-infusion, Days 1, 2, 3, 5, 8, 12, and 15 of 28-day cycle|All enrolled participants who received any quantity of study drug and had evaluable Cmax values.|||micrograms/milliliter (µg/mL)||Standard Deviation|Mean
1401269|NCT01253525|Primary|Number of Participants With Serious Adverse Events (SAEs)|The number of participants who experienced SAEs that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of SAEs and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.|||participants|||Number
1401270|NCT01253525|Primary|Number of Participants With Adverse Events (AEs)|The number of participants who experienced AEs of any grade, AEs of Grade ≥3 or AEs resulting in death that were considered to be related to ramucirumab [RAM (IMC-1121B)] or paclitaxel (PAC). A summary of serious adverse events (SAEs) and all other non-SAEs, regardless of causality, is located in the Reported Adverse Events module.|Up to 47 weeks post baseline|All enrolled participants who received any quantity of study drug.|||participants|||Number
1401271|NCT01253525|Primary|Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1|DLT based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE v4.02) in Cycle (Cy) 1 due to study drug (SD) with (w/): Grade (Gr) ≥3 neutropenia w/fever ≥38.5°C or w/bacteremia or sepsis, thrombocytopenia w/bleeding and platelet substitution, prothrombin and/or partial thromboplastin time w/no anticoagulation, hyperbilirubinemia; Gr 4: neutropenia >5 days, thrombocytopenia, Gr 4 or uncontrollable hypertension QTc>500 milliseconds (ms) or increase ≥100 ms increase in 24 hours after SD or significant arrhythmia in this period; Gr ≥3 nonhematologic toxicity (tox), excluding Gr 3 hypersensitivity, hypertension, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea w/out loperamide/nausea/vomiting w/out antiemetic and transient aminotransferase elevation. SD tox=delay >1 week in ramucirumab (RAM) dose or omission of 1 dose of RAM or 2 paclitaxel doses due to tox in Cy 1 or delay >2 weeks between Cy 1 and Cy 2 due to persistent tox.|Cycle 1 of 28-day cycle|All enrolled participants who complete the first cycle of study drug or discontinued study drug due to a DLT during Cycle 1.|||participants|||Number
1401272|NCT01253447|Secondary|Maximum Percentage Change in Apoptosis|Peripheral blood Acute Myeloid Leukemia (AML) cells (total 2 x 10^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response.|Baseline to 12 courses|The Assay did not work so no comparison can be made.||||||
1401273|NCT01253447|Primary|Number of Participants With Treatment-related Non-hematological Toxicity|Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)|Up to 30 days post-treatment||||Participants|||Count of Participants
1401274|NCT01253447|Primary|Number of Participants With a Response of CR, CRp, or PR|Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count >/= 1.0 x10^9/L, Platelet count >/= 100 x10^9/L; Bone marrow aspirate and biopsy: </= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count >/=1.0 x10^9/L, Platelet count >/= 100 x10^9/L, >/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts </= 5% if Auer rods are present. Morphologic CR with incomplete count recovery (CRp): All criteria for CR except for residual neutropenia (<1x10^9/L) or thrombocytopenia (<100 x10^9/L).|12 weeks of treatment|No participant was not evaluable for response.|||participants|||Number
1401275|NCT01253421|Secondary|Effect on NAcc-MCC Connectivity After Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between nucleus accumbens (NAcc) and mid-cingulate cortex (MCC) in response to reward outcomes.|During scan session|Data missing for 8 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
1401276|NCT01253421|Secondary|Effect on Caudate-dACC Connectivity After Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on functional connectivity between caudate and dorsal anterior cingulate cortex (dACC) in response to reward outcomes|During scan session|Data missing for 8 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
1401277|NCT01253421|Primary|Effect on Putamen Response to Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation (beta) after reward outcomes. Positive values indicate an increase in activation relative to baseline.|During scan session|Data are missing for 9 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
1401278|NCT01253421|Primary|Effect on NAcc Response to Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after reward outcomes. Positive values indicate an increase in activation relative to baseline.|During scan session|Data are missing for 10 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
1401279|NCT01253421|Primary|Effect on Caudate Response to Reward|This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after Reward outcomes. Positive values indicate an increase in activation relative to baseline.|During scan session|Data are missing for 9 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
1401280|NCT01253421|Primary|Putamen Response to Cues|This statistic shows the effect (beta) that the combination of diagnosis and drug has on putamen activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.|Scan session|Data are missing for 9 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
1401281|NCT01253421|Primary|Effect on NAcc Response to Cues|This statistic shows the effect (beta) that the combination of diagnosis and drug has on nucleus accumbens (NAcc) activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.|Scan session|Data are missing for 8 subjects due to poor MRI quality|||Effect size (Beta)||Standard Deviation|Mean
1401282|NCT01253421|Primary|Effect on Caudate Response to Cues|This statistic shows the effect (beta) that the combination of diagnosis and drug has on caudate activation after presentation of a cue. Positive values indicate an increase in activation relative to baseline.|Scan session|Data are missing for 8 subjects due to poor MRI quality.|||Effect size (Beta)||Standard Deviation|Mean
1401283|NCT01253421|Primary|Effect on PST Penalty Learning|This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from penalties during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from penalty trials.|administered after scan|Penalty-learning results are missing for 7 subjects|||Effect size (Beta)||Standard Deviation|Mean
1401284|NCT01253421|Primary|Effect on PST Reward Learning|This statistic shows the effect (beta) that the combination of diagnosis and drug has on the ability to learn from rewards during a Probabilistic Selection Task (PST). A higher effect size indicates greater ability to learn from reward trials.|administered after scan|Reward-learning results are missing for 7 subjects|||Effect size (Beta)||Standard Deviation|Mean
1401285|NCT01253408|Primary|Colonic Transit Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours||||units on a scale||Standard Deviation|Mean
1401286|NCT01253408|Secondary|Gastric Emptying at 2 and 4 Hours|Proportion of stomach contents emptied at a 2 and 4 hours.|2, 4 hours||||proportion of stomach contents||Standard Deviation|Mean
1401287|NCT01253408|Secondary|Ascending Colon Emptying T 1/2|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours after radiolabeled meal was ingested||||hours||Standard Deviation|Mean
1401288|NCT01253408|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours after radiolabeled meal was ingested||||percentage of meal||Standard Deviation|Mean
1401289|NCT01253408|Secondary|Gastric Emptying Half-Time (t1/2)|The time for half of the ingested solids or liquids to leave the stomach.|Approximately 2 hours after radiolabel meal is ingested||||minutes||Standard Deviation|Mean
1401290|NCT01253408|Secondary|Colonic Transit Geometric Center|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|28, 32, and 48 hours||||units on a scale||Standard Deviation|Mean
1401291|NCT01253369|Secondary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better objective response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.|||proportion of patients||80% Confidence Interval|Number
1401292|NCT01253369|Primary|8-Week Progression-Free Rate|The 8-week progression free rate (PFR) was defined as achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions.|For this endpoint, disease was evaluated radiologically at baseline and week 8 on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-20).|The analysis dataset is comprised of evaluable patients. Patients who had measurable disease at baseline, received at least 1 cycle of therapy and had their disease re-evaluated were considered evaluable for response.|||proportion of patients||80% Confidence Interval|Number
1401293|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score.|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.|||pg/mL||Standard Deviation|Mean
1401294|NCT01253343|Primary|Salivary Hormone Correlation With Brief Rating of Aggression by Children and Adolescent (BRACHA) Score|We collected three saliva samples from each participant over a 24-hour period on one of the initial three hospital days to determine the peripheral concentrations of cortisol, dehydroepiandrosterone (DHEA), and testosterone. We then compared these levels with the participants BRACHA score. We wanted to determine if hormone concentrations could improve the BRACHA's accuracy of predicting pediatric aggression during psychiatric hospitalization.|Collected on one or two days|The number of participants for analysis was supposed to be 24 based on Kelsey's sample size calculation (Kelsey et al., Methods in Observational Epidemiology, 2nd Edition, Table 12-15). However, due to funding constraints we only collected samples from 17 participants.|||ul/dL||Standard Deviation|Mean
1401295|NCT01253317|Secondary|Change in Social Avoidance Subscale Scores on the ADAMS From Pre-OLE to Post-OLE|The Anxiety Depression and Mood Scale (ADAMS) is completed by the parent/caregiver and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The Social Avoidance subscale [0 = best; 20 = worst] of the ADAMS is reported as a secondary outcome measure. A negative value indicates a decrease in the Social Avoidance subscale; which represents an improved outcome.|Pre-OLE (visit 1) and post-OLE (after 20 weeks of IGF-1 therapy)|The ADAMS was not completed during the MAD.|||units on a scale||Standard Error|Mean
1401296|NCT01253317|Secondary|Change From Pre-MAD Apnea Index at Post-OLE|Apnea indices were compared from pre-MAD (prior to initiating treatment) to post-OLE (after 20 weeks of IGF-1 therapy). A negative value indicates a reduction in apnea index; representing an improved outcome. Apnea Index is defined as the number of apneas (≥ 10 seconds in length) occuring within one hour. The Apnea Index is calculated by dividing the number of qualifying apneic events by the number of hours in which they occurred. An apnea index greater than or equal to 5 is considered clinically significant by the American Academy of Sleep Medicine (AASM).|pre-MAD (baseline) to post-OLE (after 20 weeks of IGF-1 treatment)|Two subjects enrolled in the MAD did not continue participation in the OLE and one subject was excluded from the analysis because, upon further medical record review, she did not meet diagnostic criteria for Rett syndrome.|||apneas per hour||Standard Error|Mean
1401297|NCT01253317|Primary|Pharmacokinetic (PK) Profile - Areas Under the Curve (AUCt)||60 minutes pre-dose and 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 8.0, and 12.0 hours post-dose on days 1, 8, 15 and 29.||||ng.h/mL||Standard Error|Mean
1401298|NCT01253317|Primary|Adverse Events||biweekly during the MAD and every five weeks during the OLE|Subjects that had the same adverse event more than once are counted only one time using the closest relationship to study medication.|||Adverse events|||Number
1401299|NCT01253304|Primary|Pharmacokinetics: Apparent Volume of Distribution (Vz/F)|The apparent volume of distribution during the terminal phase after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1401300|NCT01253304|Primary|Pharmacokinetics: Apparent Total Plasma Clearance (CL/F)|The apparent total body clearance of drug calculated after extra vascular administration is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1401301|NCT01253304|Primary|Pharmacokinetics: Apparent Terminal Elimination Half-life (t1/2)|The half life associated with the terminal rate constant is summarized. This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||hours||Full Range|Geometric Mean
1401302|NCT01253304|Primary|Pharmacokinetics: AUC From Time Zero to Infinity (AUC[0-infinity])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.|||nanograms times hr/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1401303|NCT01253304|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-tlast])|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||nanograms times hour/milliliter(ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1401304|NCT01253304|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable LY2189265 concentration data.|||hours||Full Range|Median
1401305|NCT01253304|Primary|Pharmacokinetics: Maximum Observed Concentration (Cmax)|This measure was calculated using non-compartmental analysis techniques.|Predose to 336 hours postdose|Participants who received at least one dose of study drug (LY2189265) with evaluable concentration data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1401306|NCT01253265|Secondary|Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss)|tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.|||days||Full Range|Median
1401307|NCT01253265|Secondary|Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss)|Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1401308|NCT01253265|Secondary|Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss)|AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss)|Week 10 pre-dose up to 2 weeks post-dose (Week 12)|All randomized participants with analyzable pharmacokinetic data.|||micrograms•day per milliliter(μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
1401309|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Lymphocyte Counts||Baseline, 26 weeks|All randomized participants.|||10^9 cells per liter (GI/L)||Full Range|Median
1401310|NCT01253265|Secondary|Change From Baseline to 26 Week Endpoint in Neutrophil Counts||Baseline, 26 weeks|All randomized participants.|||10^9 cells per liter (GI/L)||Full Range|Median
1401311|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h).|Baseline, 16 weeks|All randomized participants.|||percentage change in ESR||Full Range|Median
1401312|NCT01253265|Secondary|Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein|C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter.|Baseline, 16 weeks|All randomized participants.|||percentage change in C-Reactive Protein||Full Range|Median
1401313|NCT01253265|Primary|Number of Participants With Clinically Significant Effects|Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline up to 26 weeks|All randomized participants.|||participants|||Number
1401314|NCT01253200|Secondary|Chronic Success Rate: Acute Success Patients|Chronic success is defined as demonstration of acute success and freedom from recurrence of type 1 atrial flutter at 3-months post-procedure. Only randomized patients with acute procedural success will be included in this endpoint.|3-months post-procedure|The secondary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation and classified as acute success; 194 of the total 302 subjects. All consistent with approved statistical analysis plan and information publicly available in the FDA SSED and BSC the Directions for Use.|||percentage of chronic success|||Number
1401315|NCT01253200|Secondary|Chronic Success Rate: All Treated Patients|Chronic success is defined as freedom from recurrence of type 1 atrial flutter at 3-months post-procedure for all treated patients.|3 months post-procedure|The secondary outcome analysis is for a subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.|||percentage of subjects|||Number
1401316|NCT01253200|Primary|Acute Success Rate|Acute success is defined as demonstration of bidirectional cavo-tricuspid isthmus block (ie, lack of electrophysiological conduction through the isthmus) 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus with the investigational or control catheter only.|30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus|The primary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.|||percentage of success|||Number
1401317|NCT01253200|Primary|Procedure-related Complication-free Rate|A procedure-related complication is defined as an adverse event that results in death, a life-threatening complication, or a persistent or significant disability/incapacity or required intervention to prevent a permanent impairment of a body function or damage to a body structure. All adverse events related to the investigational or control devices or ablation procedure will be considered procedure-related events.|7 days post-procedure|The primary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.|||percentage of subjects|||Number
1401318|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hours||Full Range|Median
1401319|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hours||Full Range|Median
1401320|NCT01253187|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng·h/mL||95% Confidence Interval|Geometric Mean
1401321|NCT01253187|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hours||Full Range|Median
1401322|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol·h/L||95% Confidence Interval|Geometric Mean
1401323|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
1401324|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol·h/L||95% Confidence Interval|Geometric Mean
1401325|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
1401326|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng·h/mL||95% Confidence Interval|Geometric Mean
1401327|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng/mL||95% Confidence Interval|Geometric Mean
1401328|NCT01253187|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg·h/mL||95% Confidence Interval|Geometric Mean
1401329|NCT01253187|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg/mL||95% Confidence Interval|Geometric Mean
1401330|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of L-5-methyl-THF|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hour||Full Range|Median
1401331|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of DRSP|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hour||95% Confidence Interval|Median
1401332|NCT01253174|Secondary|Mean Area Under the Concentration-time Curve From Administration up to 72h AUC(0-72h) of DRSP|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 72 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng∙h/mL||95% Confidence Interval|Geometric Mean
1401333|NCT01253174|Secondary|Time to Reach Maximum Concentration (Tmax) of EE|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||hour||Full Range|Median
1401334|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected AUC is a measure of the systemic drug exposure provided by the treatment including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol∙h/L||95% Confidence Interval|Geometric Mean
1401335|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Uncorrected) Incl. Bioequivalence (BE) Evaluation|The baseline uncorrected Cmax is a measure of the highest measured drug concentration including the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples and measuring the concentrations of L-5-methyl-THF in each sample.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
1401336|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected AUC is a measure of the systemic drug exposure provided by the treatment excluding the endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol∙h/L||95% Confidence Interval|Geometric Mean
1402840|NCT01240200|Secondary|Blood Glucose Control|Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia|at 12 weeks|||||||
1401337|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of L-5-methyl-THF (Baseline Corrected) Incl. Bioequivalence (BE) Evaluation|The baseline corrected Cmax is a measure of the highest measured drug concentration provided solely by the treatment after subtracting endogenous L-5-methyl-THF level. It is obtained by collecting a series of blood samples, measuring the concentrations of L-5-methyl-THF in each sample and by subtracting the pre-treatment concentration.|up to 12 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||nmol/L||95% Confidence Interval|Geometric Mean
1401338|NCT01253174|Primary|Mean Area Under the Concentration-time Curve (AUC) of DRSP Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng∙h/mL||95% Confidence Interval|Geometric Mean
1401339|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of DRSP Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 168 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||ng/mL||95% Confidence Interval|Geometric Mean
1401340|NCT01253174|Primary|Mean Area Under the Concentration-time Curve From Administration to the Last Measurement [AUC(0-tlast)] of EE Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg∙h/mL||95% Confidence Interval|Geometric Mean
1401341|NCT01253174|Primary|Mean Maximum Concentration (Cmax) of EE Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|up to 96 hours after administration|Note that not all samples were evaluable for each outcome measure. Therefore the number of participants analyzed not necessarily matches the number of completers.|||pg/mL||95% Confidence Interval|Geometric Mean
1401342|NCT01253148|Secondary|Overall Response Rate (ORR)|Tumor Response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all target and non-target lesions; no new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions.|End of post treatment follow-up period of up to 20 months|All participants|||percentage of participants|||Number
1401343|NCT01253148|Secondary|Median Overall Survival (OS)|OS is defined as the duration of time from enrollment to time of death from any cause.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
1401344|NCT01253148|Primary|Median Progression Free Survival (PFS)|PFS is defined as the duration of time from enrollment to time of progression or death from any cause. Progression will be defined as progressive disease in the treated lobe. If progression is seen in a treated lobe, this will be considered a treatment failure. Progressive Disease (PD) according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.1.: At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|End of post treatment follow-up period of 20 months|All participants|||months||95% Confidence Interval|Median
1401345|NCT01253135|Primary|Median Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed)|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. The primary efficacy endpoint was analyzed, using Kaplan-Meier survival analysis, to estimate the median time to wound closure over the 21-day treatment period. Any wound which did not heal by Day 21 was censored in the analysis.|||days to closure||95% Confidence Interval|Median
1401346|NCT01253135|Primary|Time (in Days) to Wound Closure (Healing) Defined as Skin Re-epithelialization, Without Drainage or Dressing Requirements.|The target wounds were evaluated wound status (open/closed).|All thermal wound injury was done on Day 1. Application of test articles started on Day 2. Target wound assessment was performed on Day 3 and Day 5; subsequent assessments were done Monday through Friday for 2 weeks and subjects exited study on Day 22|ITT Populations: Subjects who participated in version 2 of the protocol. Inter-group comparison was done using a paired Prentice-Wilcoxon method, which is applicable to censored data.|||days to wound closure||Standard Deviation|Mean
1401347|NCT01253070|Secondary|Event-free Survival|Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.|Time from registration to death or relapse (up to 10 years)||||months||95% Confidence Interval|Median
1401348|NCT01253070|Secondary|OS|OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Time from registration to death (up to 10 years)||||months||95% Confidence Interval|Median
1401349|NCT01253070|Primary|Overall Survival (OS) Rate|Percentage of patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.|1 year|Three participants withdrew consent to protocol treatment and follow-up prior to 1 year post registration (2 ITD; 1 TKD). These participants have been excluded from the primary endpoint analysis.|||percentage of participants||95% Confidence Interval|Number
1401350|NCT01253044|Secondary|Sheehan Disability Inventory|To determine if receiving ACT, as compared to PCT, is associated with reduced functional impairment at the end of treatment. The score used is an average (range 0-10) of completed items, with higher scores indicating greater disability.|Baseline and week 12||||units on a scale||Standard Deviation|Mean
1401351|NCT01253044|Primary|Brief Symptom Inventory 18 (BSI-18)|To determine if receiving ACT, as compared to PCT, is associated with reduced distress as measured by the BSI-18 General Symptom Index (GSI) at the end of treatment. The BSI-18 GSI summarizes a respondent's overall level of distress. The score used in a normatively based T-score (range 1-100) calculated from the sum of responses. Higher scores are indicative of greater distress.|Baseline and week 12||||T-score||Standard Deviation|Mean
1401352|NCT01253018|Secondary|Stroke Impact Scale: Hand Subscale|The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.|Baseline, 12 week and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 12 and the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.|||units on a scale||Standard Deviation|Mean
1401353|NCT01253018|Secondary|Wolf Motor Function Test (WMFT)|The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. The change score from baseline to the final (12 week) evaluation was examined. 1 participant in each group did not return for retention and were not included in the retention analysis.|||seconds||Standard Deviation|Mean
1401354|NCT01253018|Secondary|Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)||week 12|The severity of the patients enrolled in the study were such that TMS did not evoke the number of motor action potentials needed for analysis.||||||
1401355|NCT01253018|Primary|Fugl-Meyer Motor Upper Extremity Assessment|This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.|Baseline, 12 week, and 24 week retention|All participants completing the 12 week intervention including evaluations at baseline, weeks 4, 8, 12 and at the 24 week retention evaluation. 1 participant in each group did not return for retention and were not included in the retention analysis.|||units on a scale||Standard Deviation|Mean
1401356|NCT01252966|Secondary|Cognitive Performance (Attention)|Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row. The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline). There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at Baseline were excluded as outliers.|||Change in number of commission errors||Standard Deviation|Mean
1401357|NCT01252966|Secondary|Cognitive Performance (Response Inhibition)|"Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of stimuli (the word PRESS in either green or red). Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red. The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline. The potential range for the change score is -42 to 42. Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change."|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.|||Change in number of commission errors||Standard Deviation|Mean
1401358|NCT01252966|Secondary|Cognitive Performance (Working Memory)|Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12). In this task, participants are presented with a series of digits on the computer screen at one second intervals. Participants are then required to enter the digits in order. The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly. The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score). Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.|Baseline and Week 12 (EOT)|Participants with performance >3SD from the mean at baseline were excluded as outliers.|||Change in maximum recall span||Standard Deviation|Mean
1401402|NCT01252277|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value||||change in units on a scale||Inter-Quartile Range|Median
1401359|NCT01252966|Secondary|Point-prevalence Abstinence at 6-month Follow-up|Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|6 month follow-up||||Percentage of participants|||Number
1401360|NCT01252966|Primary|Point-prevalence Abstinence at End of Treatment|Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure. Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm). Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.|End of treatment (Week 12)||||Percentage of participants|||Number
1401361|NCT01252953|Secondary|Number of Participants With Major Vascular Event|"Major vascular events (defined as coronary death, myocardial infarction, coronary revascularization or presumed ischaemic stroke).~Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period"|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
1401362|NCT01252953|Secondary|Number of Participants With Presumed Ischaemic Stroke|"Presumed ischaemic stroke (i.e. not known to be haemorrhagic).~Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period."|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
1401363|NCT01252953|Secondary|Number of Participants With Major Atherosclerotic Event|"Major atherosclerotic events (defined as coronary death, myocardial infarction or presumed ischaemic stroke; the key secondary outcome).~Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period."|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
1401364|NCT01252953|Primary|Number of Participants With Major Coronary Event|"Primary assessment involves an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib versus placebo on major coronary events (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period.~Data reported is for the first major coronary event."|Randomized treatment phase during median follow-up period of 4.1years||||Participants|||Count of Participants
1401365|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 48|"The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
1401366|NCT01252940|Secondary|Change From Baseline in Fasting Triglycerides Through Week 24|The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for triglycerides at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
1401367|NCT01252940|Secondary|Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
1401368|NCT01252940|Secondary|Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for direct LDL cholesterol at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
1401369|NCT01252940|Secondary|Change From Baseline in Fasting HDL Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
1401370|NCT01252940|Secondary|Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24|The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for HDL cholesterol at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
1401371|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 48|"The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 48 were analyzed.|||mg/dL||Standard Deviation|Mean
1401372|NCT01252940|Secondary|Change From Baseline in Fasting Total Cholesterol Through Week 24|The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.|Baseline to Week 24|Participants in the Safety Analysis Set who had measurements for total cholesterol at both baseline and Week 24 were analyzed.|||mg/dL||Standard Deviation|Mean
1401403|NCT01252277|Primary|The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day|The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.|6 month visit||||proportion of enrolled participants|||Number
1401373|NCT01252940|Secondary|Change From Baseline in CD4 Count Through Week 48|"The mean (SD) change in CD4 count was analyzed from baseline through Week 48.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Baseline to Week 48|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 48 were analyzed.|||cells/mm^3||Standard Deviation|Mean
1401374|NCT01252940|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24|The mean (SD) change in CD4 count was analyzed from baseline through Week 24.|Baseline to Week 24|Participants in the Full Analysis Set who had CD4 measurements at both baseline and Week 24 were analyzed.|||cells/mm^3||Standard Deviation|Mean
1401375|NCT01252940|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)|"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.~By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF."|Week 48|Participants in the Full Analysis Set in the FTC/RPV/TDF and the Delayed Switch to FTC/RPV/TDF groups were analyzed.|||percentage of participants|||Number
1401376|NCT01252940|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.|Week 24|Full Analysis Set: participants who were randomized into the study and received at least one dose of study drug.|||percentage of participants|||Number
1401377|NCT01252810|Secondary|Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections|Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).|2, 6 and 24 hours post Ioforminol and Iopamidol adminstration|Summary of subjects with renal biomarker-based CI-AKI by time point (Per Protocol Population).|||Subjects|||Number
1401378|NCT01252810|Secondary|To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration|"To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.~To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.~Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects."|Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.|Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.|||Number of events|||Number
1401379|NCT01252810|Primary|Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.|Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.|After the imaging date for either Ioforminol or Iopamidol.|The measured values are looking at 1) Overall Image Quality and, 2) Diagnostic Usefulness.|||Number of subjects|||Number
1401380|NCT01252745|Primary|AUC0-t of Serum Testosterone||24 hours||||ng.h/dL||Standard Deviation|Mean
1401381|NCT01252745|Primary|Cavg of Serum Testosterone||24 hours||||ng/dL||Standard Deviation|Mean
1401382|NCT01252745|Primary|Cmax of Serum Testosterone||24 hours||||ng/dL||Standard Deviation|Mean
1401383|NCT01252355|Other Pre-specified|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Hepatic parameters thresholds were defined as follows: Alanine Aminotransferase (ALT) >3, 5 or 10 Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) >3, 5 or 10 ULN; Alkaline Phosphatase >1.5 ULN; Total Bilirubin (TB) >1.5 ULN; and ALT >3 ULN and TB >2 ULN.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population as previously defined but including only participants who had post-baseline values.|||participants|||Number
1401384|NCT01252355|Secondary|Overview of Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|First study drug intake up to 28 days after last study drug intake, for up to 112 weeks|Safety population: all randomized and treated participants. Participants were included in the treatment group according to the drug actually received.The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group.|||participants|||Number
1401385|NCT01252355|Secondary|Resource Utilization When Relapse|Resource utilization each time a participant experiences an MS relapse, specifically the number of hospitalizations, the number of over night spent in the hospital and number of intensive care admissions if hospitalized were to be reported.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
1401386|NCT01252355|Secondary|Change From Baseline in Short Form Generic Health Survey - 36 Items, Version 2 (SF-36v2) Summary Scores at Week 24|SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
1401387|NCT01252355|Secondary|Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 24|FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS.|Baseline, Week 24|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
1401388|NCT01252355|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of no Relapse at Week 24, 48, and 72|Probability of no relapse at 24, 48 and 72 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse. Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time <=t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined.|||percent probability of no relapse||95% Confidence Interval|Number
1401389|NCT01252355|Secondary|Brain MRI Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease) at Week 24|The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, region, IFN-beta dose stratum, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.|Baseline, Week 24|ITT population as previously defined but including only participants who had post-baseline data.|||milliliter||Standard Error|Least Squares Mean
1401390|NCT01252355|Secondary|Brain MRI Assessment: Volume of Gd-enhancing T1-lesions Per MRI Scan|Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period.|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.|||milliliters per scan|||Number
1401391|NCT01252355|Secondary|Time to 12-Week Sustained Disability Progression|The 12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks. Probability of disability progression was to be estimated using Kaplan-Meier method.|Up to a maximum of 108 weeks depending on time of enrollment|Data for this outcome was not analyzed because of insufficient data after early study termination.||||||
1401392|NCT01252355|Secondary|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per Scan (Poisson Regression Estimates)|Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different number of scans among participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable; log-transformed number of scans as offset variable; treatment group, region of enrollment, IFN-beta dose stratum and baseline number of Gd-enhancing T1-lesions as covariates).|Up to a maximum of 108 weeks depending on time of enrollment|ITT population as previously defined but including only participants who had post-baseline data.|||lesions per scan||95% Confidence Interval|Number
1401393|NCT01252355|Primary|Annualized Relapse Rate (ARR) (Poisson Regression Estimates)|"ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and IFN-beta dose stratum, and number of relapses in the year prior to randomization as covariates)."|Up to a maximum of 108 weeks depending on time of enrollment|Intent-to-treat (ITT) population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||relapses per patient-year||95% Confidence Interval|Number
1401394|NCT01252290|Secondary|Change in Ki-67 Expression|Immunocytochemical staining for Ki-67 antibody. Percent of 500 benign breast epithelial cells scored that are classified as positively staining.|6 month value compared to baseline value||||change in percent Ki-67 expression||Inter-Quartile Range|Median
1401395|NCT01252290|Secondary|Change in Quality of Life|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. Summation score of degree of difficulty (scored 0 to 4 each) with 43 individual activities. Thus total score ranges from 0 to 172. Increasing score represents increasing problems with side effects.|Change from Baseline to Month 6||||units on a scale||Full Range|Median
1401396|NCT01252290|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and AA (measured as percent of total fatty acid content) in the phospholipid compartment of plasma.|Change from Baseline to Month 6||||ratio||Inter-Quartile Range|Median
1401397|NCT01252290|Secondary|Modulation of the Risk Biomarker Masood Score|Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.|6 month value compared to baseline value||||units on a scale||Inter-Quartile Range|Median
1401398|NCT01252290|Primary|The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day|To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.|6 month visit||||proportion of enrolled participants|||Number
1401399|NCT01252277|Secondary|Change in Quality of Life.|Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.|duration of intervention, baseline to ~ 6 months|Subjects completing intervention|||units on a scale||Inter-Quartile Range|Median
1401400|NCT01252277|Secondary|Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma.|Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (AA); measured as percent of total fatty acid content in the phospholipid compartment of plasma.|baseline to end of intervention (~6 months)|Subjects completing intervention|||ratio||Inter-Quartile Range|Median
1401401|NCT01252277|Secondary|Modulation of Ki-67 Expression|Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67|6 month value compared to baseline value||||Change in percent Ki-67 expression||Inter-Quartile Range|Median
1401404|NCT01252251|Secondary|Median Overall Survival (OS)||Up to 3 years||||months||Full Range|Median
1401405|NCT01252251|Secondary|Safety and Toxicity in This Patient Population.|Safety assessments will consist of monitoring and recording all adverse events, including serious adverse events, the regular monitoring of hematology (including glycosylated hemoglobin and coagulation parameters), blood chemistry (including fasting glucose, thyroid function tests, GH, IGF-1 and prolactin), urinalysis, regular monitoring of vital signs, echocardiography, ECGs, and body weight. Toxicity will be assessed using the NCI-CTC for Adverse Events, version 4.0 (CTCAEv4.0,|16 weeks||||Participants|||Count of Participants
1401406|NCT01252251|Secondary|Median Progression Free Survival(PFS)||Up to 3 years||||weeks||Full Range|Median
1401407|NCT01252251|Primary|Number of Participants With Stable Disease (SD)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks||||Participants|||Count of Participants
1401408|NCT01252251|Primary|Number of Participants With Partial Response (PR)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks||||Participants|||Count of Participants
1401409|NCT01252251|Primary|Number of Participants With Complete Response (CR)|For patients with metastatic uveal melanoma treated with RAD001 and pasireotide LAR.|at 16 weeks||||Participants|||Count of Participants
1401410|NCT01252238|Other Pre-specified|Pulse Wave Velocity|Measure of pulsewave velocity cm/s|12 weeks|Comparison of baseline vs at 12 weeks on study drug|||cm/s||Standard Error|Mean
1401411|NCT01252238|Secondary|Aortic Compliance|Characteristic aortic imedeance, dynes x s/cm5|12 weeks|Comparison of Baseline vs. study drug at 12 week2|||dyne x sec/cm5||Standard Error|Mean
1401412|NCT01252238|Primary|Change in Insulin Sensitivity by HOMA at 12 Weeks|The difference (change) in HOMA calculated as Baseline HOMA minus 12-week HOMA value|12 weeks||||HOMA Scale||Standard Deviation|Mean
1401413|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)||Baseline to Month 6|Per-protocol population with available data|||mIU/L||Standard Error|Least Squares Mean
1401414|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin||Baseline to Month 6|Per-protocol population with available data|||nmol/L||Standard Error|Least Squares Mean
1401415|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Cortisol||Baseline to Month 6|Per-protocol population|||nmol/L||Standard Error|Least Squares Mean
1401416|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)||Baseline top Month 6|Per-protocol population with available data|||mIU/L||Standard Error|Least Squares Mean
1401417|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)|Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.|Baseline to Month 6|Per-protocol population|||ng/mL||Standard Error|Least Squares Mean
1401418|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Total Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with activated protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1401419|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Free Protein S|"Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with Protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1401420|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Antigen|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% in adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1401421|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Protein C Activity|"Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1401422|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Antithrombin|"Antithrombin is a protein in the blood that naturally blocks blood clots from forming.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 80% to 130%.for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1401423|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VIII|"Clotting factor VIII, also known as anti-hemophilic factor (AHF), functions in blood coagulation by stabilizing fibrin clots.~Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%.for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1401424|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor VII|"Clotting factor VII, also called proconvertin or autoprothrombin I, functions in blood coagulation.~Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults."|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1403388|NCT01235338|Primary|Cmax of d-Amphetamine|d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|PAS|||ng/ml||Standard Deviation|Mean
1401425|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Factor II|Clotting factor II, also called prothrombin, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.|Baseline to Month 6|Per-protocol population|||percentage of normal||Standard Error|Least Squares Mean
1401426|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)|Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.|Baseline to Month 6|Per-protocol population|||µg/L||Standard Error|Least Squares Mean
1401427|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasminogen|Plasminogen is the precursor of plasmin, which lyses fibrin clots.|Baseline to Month 6|Per-protocol population|||g/L||Standard Error|Least Squares Mean
1401428|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Fibrinogen|Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.|Baseline to Month 6|Per-protocol population|||g/L||Standard Error|Least Squares Mean
1401429|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)|"This assay is based on measurement of the effect of activated protein C on the endogenous thrombin potential, the time integral of thrombin generation initiated in plasma through the extrinsic coagulation pathway.~The APC resistance assay measures the ratio of endogenous thrombin potential in the presence and absence of a standard amount of exogenous APC.~APC resistance is calculated as the ratio of EPT after APC addition over the EPT with no APC addition.~APC resistance is defined as a poor anticoagulant response of plasma to APC (less inhibition of thrombin formation) and a correspondingly higher ratio."|Baseline to Month 6|Per-protocol population|||ratio||Standard Error|Least Squares Mean
1401430|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)|"The APC resistance assay is a clotting test that measures the ratio of APTT clotting times in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of the clotting time after APC addition over the clotting time with no APC addition.~APC resistance is defined as a poor anticoagulant response of plasma to APC (minimal prolongation of the APTT) and a correspondingly low ratio."|Baseline to Month 6|Per-protocol population with available data|||ratio||Standard Error|Least Squares Mean
1401431|NCT01252186|Secondary|Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex|The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population|||ng/mL||Standard Error|Least Squares Mean
1401432|NCT01252186|Secondary|Change From Baseline to End of Month 6 in D-dimer|D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.|Baseline to Month 6|Per-protocol population|||ng/mL||Standard Error|Least Squares Mean
1401433|NCT01252186|Primary|Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels|Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.|Baseline to Month 6|Per-Protocol (PP) Population included all data from ITT participants obtained prior to experiencing major protocol violations.|||pmol/L||Standard Error|Least Squares Mean
1401434|NCT01252147|Primary|Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Intra-rater (within raters) agreement of the GEA-J scores (1=minimum, 2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 rater who evaluated 68 subjects using GEA-J scale with photonumeric guide, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.|||Kappa statistics||95% Confidence Interval|Number
1401435|NCT01252147|Primary|Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1|Inter-rater agreement (among raters) of the GEA-J scores (1=minimum,2=moderate, 3=marked, 4=very marked) to assess eyelash prominence was evaluated using Kendall’s coefficient of concordance (Kendall’s W). Each of 7 raters who scored 68 subjects’ eyelashes using GEA-J Scale with photonumeric guide at 2 different time points at day 1. The overall inter-rater agreement for Kendall’s W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall’s W was interpreted according to the reference range scale that was pre-defined as: <=0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial, 0.81-1:00: almost perfect. The 95% confidence interval for Kendall’s W is provided.|Day 1|Enrolled population, defined as all patients who were enrolled in (started) the study.|||Kendall's W||95% Confidence Interval|Number
1401436|NCT01252134|Secondary|Corneal Staining Extent|Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.|||percentage of cornea||Standard Deviation|Mean
1401437|NCT01252134|Secondary|Corneal Staining Type|Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.|8 hours|This reporting group includes all participants who completed the study.|||Units on a scale||Standard Deviation|Mean
1402841|NCT01240200|Secondary|Blood Glucose Control|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 0 weeks|||||||
1401438|NCT01252134|Secondary|Subjective Comfort|Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.|8 hours|This reporting group includes all participants who completed the study.|||Units on a scale||Standard Deviation|Mean
1401439|NCT01252134|Primary|Ex Vivo Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.|8 hours|This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error.|||degrees||Standard Deviation|Mean
1401440|NCT01252095|Primary|Maximum Tolerated Dose (MTD) Based on DLT|The primary objective of this study is the determination of the MTD. Due to the premature termination of the study the MTD could not be determined. The outcome measure presented is the number of DLTs per cohort.|Following first 1 month cycle|Patients had to complete cycle 1 per protocol.|||DLTs|||Number
1401441|NCT01251978|Secondary|Visual Acuity (LogMar)||12 months||||LogMar|||Number
1401442|NCT01251978|Secondary|Tumor Thickness||baseline and 1 year||||millimeters (mm)||Full Range|Mean
1401443|NCT01251978|Primary|To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.||1 year|complications were only assessed in the high dose group|||participant|||Number
1401444|NCT01251952|Secondary|To Evaluate the Effect of Ontak on Engraftment of Neutrophils and Platelets Post Transplant at Each Dose.|During hospitalization stay (approximately 2 weeks), participants will receive injections of G-CSF on a daily basis starting on Day 6 and ending when white blood cells have engrafted. Participants usually remain hospitalized until engraftment.|days 0 and 21 post autologous stem cell transplantation|||||||
1401445|NCT01251952|Secondary|To Evaluate the Effect of Ontak on T Cell CD4/CD8 Reconstitution Post Transplant at Each Dose.||days 0 and 21 post autologous stem cell transplantation|||||||
1401446|NCT01251952|Secondary|To Evaluate the Effect of Ontak on the Number and Percentage of Regulatory T Cells in the Peripheral Blood Post Transplant at Each Dose Level.||days 0 and 21 post autologous stem cell transplantation|||||||
1401447|NCT01251952|Primary|Assess Toxicities of Giving Two Doses of Ontak at Days 0 and 21 Post Autologous Stem Cell Transplantation in a Dose Escalation Fashion.|After drug infusion, participants will be closely monitored for at least 4 hours for side effects|Up to 21 days post transplant|||||||
1401448|NCT01251770|Secondary|IV Fluid Intake||12 hours from baseline||||ml||Standard Deviation|Mean
1401449|NCT01251770|Primary|Change in Sodium Levels||Change from baseline in sodium level after 12 hours||||mEq/L||Standard Deviation|Mean
1401450|NCT01251757|Secondary|Percentage With Good (<=100mg/dL) Low Density Lipoprotein (LDL) Control|Using the last LDL measurement (fasting or nonfasting) available in the EMR post randomization, we defined good control as an LDL level <= 100 mg/dL.|12 months post randomization|All randomized participants who were taking a statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.|||percentage with controlled LDL|||Number
1401451|NCT01251757|Secondary|Post Intervention Low Density Lipoprotein (LDL) Level|We used the latest LDL (fasting or nonfasting) available during 12 months post randomization. no missing data were imputed.|12 months post randomization|All randomized participants who were taking statin at the time of randomization and who had at least one post randomization LDL measurement recorded in the EMR. Missing data were not imputed.|||mg/dL||Standard Deviation|Mean
1401452|NCT01251757|Secondary|Percentage With Good (<140/90 mmHg) Blood Pressure Control|Using the mean of last 5 available blood pressure measurements post randomization, we defined BP control as a means systolic BP <140 mmHg and a mean diastolic BP < 90 mmHg.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization and who had at least one post randomization BP recorded in the EMR. Missing data were not imputed.|||percentage of subjects with good control|||Number
1401453|NCT01251757|Secondary|Systolic Blood Pressure (SBP)|Mean of last 5 SBP measurements captured in the electronic medical record for the 12 months post randomization.|12-months post randomization|The analysis sample was restricted to ACEI/ARB users with at least one post intervention SBP measurement recorded in the EMR. We did not impute any missing data.|||mm Hg||Standard Deviation|Mean
1401454|NCT01251757|Secondary|Percentage With Good (>80%) ACEI/ARB Adherence|Binary indicator of good ACEI/ARB adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization|||Percent with good adherence|||Number
1401455|NCT01251757|Secondary|Percentage With Good (>80%) Statin Adherence|Binary indicator of good statin adherence, defined as an mMPR>0.80. 1=yes, 0=no.|12 months post randomization|All randomized participants who were taking statins at the time of randomization.|||percent with good adherence|||Number
1401456|NCT01251757|Primary|Adherence to Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs)|We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for the subset of randomized participants who were using ACEIs or ARBs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications.|12 months post randomization|All randomized participants who were taking an ACEI or an ARB at the time of randomization|||mMPR expressed as a fraction||Standard Deviation|Mean
1401471|NCT01251653|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was the time from the first documented complete response or partial response to disease progression or death.|From the first documented complete response or partial response to the time of disease progression or death|TS for patients who experienced objective response.|||Days||Standard Deviation|Mean
1401610|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401457|NCT01251757|Primary|Adherence to Statins|"We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days’ supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days’ supply that would extend beyond the end of the window.~We used medication dispensing data from the Kaiser outpatient pharmacies to calculate a modified medication possession ratio (mMPR) for statins among the subset of randomized participants who were using these drugs. Nominally mMPR provides an estimate of the proportion of days during the follow-up period during which the participant was adherent to their prescribed medications."|12 months post randomization|All randomized participants who were taking statins at the time of randomization|||mMPR as a fraction||Standard Deviation|Mean
1401458|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Docetaxel|Apparent volume of distribution at steady state (Vss) of Docetaxel.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||L||Geometric Coefficient of Variation|Geometric Mean
1401459|NCT01251653|Secondary|Total Clearance (CL) of Docetaxel|Total Clearance (CL) of Docetaxel from plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1401460|NCT01251653|Secondary|Cmax of Docetaxel|Maximum concentration of docetaxel in plasma.|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1401461|NCT01251653|Secondary|AUC 0-24 of Docetaxel|Area under the concentration-time curve of docetaxel in plasma over the time interval from 0 up to 24 hours|PK samples were taken on day 1 at hours; -0:05, 1, 2, 3, 5, 7, 23:55 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1401462|NCT01251653|Secondary|Volume of Distribution at Steady State (Vss) of Gemcitabine|Apparent volume of distribution at steady state (Vss) of Gemcitabine.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||L||Geometric Coefficient of Variation|Geometric Mean
1401463|NCT01251653|Secondary|Total Clearance (CL) of Gemcitabine|Total Clearance (CL) of Gemcitabine from plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1401464|NCT01251653|Secondary|Cmax of Gemcitabine|Maximum concentration of Gemcitabine in plasma.|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1401465|NCT01251653|Secondary|AUC 0-tz of Gemcitabine|Area under the concentration-time curve of Gemcitabine in plasma over the time interval from 0 up to the last quantifiable data point|PK samples were taken on day 1 at hours; -0:05, 0:30, 1, 1:30, 2, 3 and on day 22 at hours; -0:10, 0:30, 1, 1:30, 2, 3|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1401466|NCT01251653|Secondary|Cmax,ss of Afatinib|Maximum concentration of Afatinib in plasma at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1401467|NCT01251653|Secondary|Area Under the Concentration-time Curve (AUC) Tau,ss of Afatinib|Area under the concentration-time curve of Afatinib in plasma over a uniform dosing interval t at steady state.|PK samples were taken at hours; 167:55, 479:55, 481:05, 482:05, 483:05, 485:05, 487:05 and on day 22 at hours; -0:10, 1, 2, 3, 5, 7, 23:55|The Pharmacokinetic Set (PKS) was a subset of the Treated Set that included all patients who had taken at least 1 dose of study medication and for whom at least 1 valid plasma concentration was available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1401468|NCT01251653|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first administration of study medication to the time of death from any cause.|From the first administration of study medication to the time of death|TS, MTD cohort|||Weeks||Inter-Quartile Range|Median
1401469|NCT01251653|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the first administration of study medication to the time of disease progression or death, whichever occurred first.|From the first administration of study medication to the time of disease progression or death|TS, MTD cohort|||Weeks||Inter-Quartile Range|Median
1401470|NCT01251653|Secondary|Duration of Disease Control According to RECIST v1.1|Duration of disease control according to RECIST v1.1.|From the first administration of study medication to the time of disease progression or death|TS for patients who experienced disease control.|||Days||Standard Deviation|Mean
1402877|NCT01239511|Secondary|Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits||6 weeks|||||||
1401472|NCT01251653|Secondary|Time to Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Time to objective response is the time from the start of treatment to the date of first documented complete response or partial response. Descriptive analyses has been performed for the time to objective response (N(%) of patients with first occurrence of objective response at 6, 12 and 24 weeks). Onset of objective response is derived for patient with measurable disease.|6 weeks, 12 weeks and 24 weeks|TS|||Participants|||Number
1401473|NCT01251653|Secondary|Objective Response According to RECIST v1.1|Objective response according to RECIST v1.1. Objective response is complete response or partial response for patients with measurable disease. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
1401474|NCT01251653|Secondary|Disease Control According to RECIST v1.1|Disease control according to RECIST v1.1 Disease control is complete response, partial response or stable disease for measurable patients and complete response or non−CR/non−PD for non−measurable patients. Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
1401475|NCT01251653|Secondary|Best Overall Response According to RECIST v1.1 Criteria|Best overall response (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) was the best response recorded at any time from the date of the first administration of afatinib or gemcitabine/docetaxel to the end of treatment (EOT). Partial response is for patients with measurable disease. Missing categories signifies that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed.|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
1401476|NCT01251653|Secondary|The Incidence and Intensity of AEs With Grading According to CTCAE.|The incidence and intensity of adverse events with grading according to CTCAE. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first drug administration until 28 days after last drug administration, up to 717 days.|TS|||Participants|||Number
1401477|NCT01251653|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).|DLT was based on following criterions: 1. Grade 4 uncomplicated (not associated with fever >38.5° C (Celsius)) neutropenia for ≥7 days. 2. Grade 3 or 4 neutropenia concomitant with fever >38.5º C or Grade ≥3 infection. 3. Platelet count of <25x 10^9/L or <50x 10^9/L with bleeding requiring whole blood transfusion. 4. Grade ≥3 non-haematological toxicity (except untreated nausea, untreated vomiting, or untreated diarrhoea). 5. Grade ≥2 decrease in cardiac left ventricular function. 6. Grade ≥2 worsening of renal function as measured by serum creatinine, newly developed proteinuria, or a newly developed decrease in glomerular filtration rate. Toxicity grading was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0|3 weeks|Treated Set (TS)|||Participants|||Number
1401478|NCT01251614|Secondary|Change From Baseline in the Children's Depression Inventory: Short (CDI:S)|The CDI:S is a short 10-item self-rated symptom-oriented scale used to screen for depressive symptoms. CDI:S scores range from 0 to 100, with a lower score indicating fewer depressive symptoms.|Baseline, Period A, Weeks 4, 8, and 16|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.|||units on a scale||Standard Deviation|Mean
1401479|NCT01251614|Secondary|Change From Baseline in PedsQL Over Time|The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).|Baseline, Period A, Weeks 4 and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.|||units on a scale||Standard Deviation|Mean
1401480|NCT01251614|Secondary|Time to PASI 50/75/90/100 Response in Period A|Participants who did not have a response during Period A were censored.|Period A, 16 weeks|Analysis was conducted in the intent to-treat (ITT) population.|||days||Inter-Quartile Range|Median
1401481|NCT01251614|Secondary|Percentage of Participants With CDLQI = 0 Over Time|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired and a score of 0 indicates no impairment in quality of life.|Period A, Weeks 4, 8 and 16, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|Non-responder imputation was used, the analysis was conducted in the intent to-treat (ITT) population.|||percentage of participants|||Number
1401482|NCT01251614|Secondary|Change From Baseline in CDLQI Over Time|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline, Period A, Weeks 4, and 8, Period C, Weeks 0 and 4, Period D, Weeks 0, 11, 28, and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population with available data at baseline.|||units on a scale||Standard Deviation|Mean
1401483|NCT01251614|Secondary|Percent Change From Baseline in PASI Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percent change||Standard Deviation|Mean
1402878|NCT01239511|Secondary|Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits||6 weeks|||||||
1401484|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 100 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
1401485|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 90 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
1401486|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 75 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 75 response is at least a 75% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
1401487|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 50 Response Over Time|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 50 response is at least a 50% reduction (improvement) from Baseline in PASI score."|Baseline, Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
1401488|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) Over Time"|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.~The percentage of participants achieving a score of clear (0) is reported."|Period A, Weeks 4, 8, 11 and 16, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
1401489|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) or Minimal (1) Over Time"|The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.|Period A, Weeks 4, 8 and 11, Period C, Weeks 0 and 16, Period D, Weeks 0, 16, 28, 40 and 52|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
1401490|NCT01251614|Secondary|Time to Loss of Disease Control for Participants Who Entered Period B|"Loss of disease control was defined as a worsening of PGA scores in comparison to Week 16 of Period A by at least 2 grades after treatment withdrawal. The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. Scores range from 0 (no evidence of scaling, erythema, or plaque elevation) to 5 (very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation).~Participants who did not lose disease control in period B continued off drug into period D and were observed off-drug until they finally lost disease control or until the end of the 52 weeks of period D."|Period B (36 weeks) and Period D (52 weeks)|This analysis was conducted in the ITT population who entered period B, no imputation was used.|||days||Inter-Quartile Range|Median
1401491|NCT01251614|Secondary|"Percentage of Participants Achieving a PGA of Cleared (0) or Minimal (1) Upon Re-Treatment in Period C"|The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; 1 (Minimal): Occasional fine scale over < 5% of lesions, faint erythema, minimal plaque elevation; 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.|Period C, Week 16|Non-responder imputation was used, the analysis was conducted in the ITT population who entered Period C.|||percentage of participants|||Number
1401554|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH)|Blood samples for MCH were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||picograms (pg)||Full Range|Mean
1401492|NCT01251614|Secondary|Change From Baseline in the Pediatric Quality of Life Inventory (PedsQL) Score at Week 16|The PedsQL Measurement Model measures health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL Generic Core Scale includes Physical, Emotional, Social, School Functioning dimensions. Each item is scored from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL; the total score therefore ranges from 0 (worst) to 100 (best).|Baseline and Week 16|LOCF imputation was used, the analysis was conducted in the intent-to-treat (ITT) population; only participants with Baseline and at least one post-baseline value are included.|||units on a scale||Standard Deviation|Mean
1401493|NCT01251614|Secondary|Change From Baseline in the Children's Dermatology Life Quality Index (CDLQI) Score at Week 16|The Children's Dermatology Life Quality Index (CDLQI) is a 10-item questionnaire to measure the quality of life in children aged from 4 to 16 years. Each question is scored from 0 (not at all) to 3 (very much). The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline and Week 16|Last observation carried forward (LOCF) imputation was used, the analysis was conducted in the intent-to-treat (ITT) population; only participants with Baseline and at least one post-baseline value are included.|||units on a scale||Standard Deviation|Mean
1401494|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 100 Response at Week 16|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 100 response is a 100% reduction (improvement) from Baseline in PASI score at Week 16."|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percentage of participants|||Number
1401495|NCT01251614|Secondary|Percentage of Participants Who Achieved a PASI 90 Response at Week 16|"PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).~A PASI 90 response is at least a 90% reduction (improvement) from Baseline in PASI score at Week 16."|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percentage of participants|||Number
1401496|NCT01251614|Primary|"Percentage of Participants Achieving a Physician’s Global Assessment of Disease Activity (PGA) of Cleared (0) or Minimal (1) at Week 16"|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:~0 (Cleared): No evidence of scaling, erythema, or plaque elevation;~1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;~2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;~3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;~4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;~5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.~The percentage of participants achieving a score of clear (0) or minimal (1) is reported."|Week 16|Non-responder imputation was used, the analysis was conducted in the ITT population.|||percentage of participants|||Number
1401497|NCT01251614|Primary|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 75 Response at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in PASI score at Week 16.|Baseline and Week 16|Non-responder imputation was used, the analysis was conducted in the intent-to-treat (ITT) population.|||percentage of participants|||Number
1401498|NCT01251588|Secondary|Number of Participants Having Subsequent Surgical Procedures (SSPs) in Target Knee||Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
1401499|NCT01251588|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs)||Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
1401500|NCT01251588|Secondary|Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)||Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
1401501|NCT01251588|Secondary|Change From MACI00206 Baseline in the European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Score|The EQ-5D is a standardized instrument for use as a measure of health outcome (see the EuroQOL Website for details: www.euroqol.org). Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ Visual Analogue Scale (VAS) was used to record the respondents’ self-rated health status on a vertical graduated (0-100) VAS where 0 is ‘the worst health you can imagine’ and 100 is ‘the best health you can imagine’.|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 58 of the 63 microfracture-treated patients enrolled in MACI00809 completed the EQ-5D VAS Score at Week 260.|||units on a scale||Full Range|Mean
1401502|NCT01251588|Secondary|Change From MACI00206 Baseline in the 12-Item Short-Form Health Survey (SF-12) Physical and Mental Component Scores|"The SF-12 is a subset of the 36-Item Short–Form Health Survey (SF-36) and includes 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are used to calculate the physical (PCS) and mental (MCS) summary component scores.~MCS and PCS are summarized as Z-scores using standard SF-12 scoring and a US population means. The Z-score indicates how many standard deviations a score is from the population mean. Higher values reflect better health. Changes from Baseline are reported."|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 55 of the 63 microfracture-treated patients enrolled in MACI00809 completed the 12-Item Short-Form Health Survey at Week 260.|||Z-score||Full Range|Mean
1401628|NCT01250769|Secondary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||ug/mL||95% Confidence Interval|Least Squares Mean
1401503|NCT01251588|Secondary|Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the Modified Cincinnati Knee Rating System|The Modified Cincinnati Knee Rating System is a self-assessment of the intensity of sports participation, functional limitations, and the ability to participate in different types of sports. The Modified Cincinnati Knee Rating System overall knee condition score ranges from 1 (poor) to 10 (excellent).|MACI00206 Baseline and Week 260|65 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the Modified Cincinnati Knee Rating System at Week 260.|||units on a scale||Full Range|Mean
1401504|NCT01251588|Secondary|Change From MACI00206 Baseline in the Patient's Evaluation of Overall Knee Condition Using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form|"The IKDC Subjective Knee Evaluation Form is a validated knee-specific measure of symptoms, function, and sports activity that is appropriate for patients with a wide variety of knee problems. The form consists of 18 items covering the domains of symptoms, functioning during activities of daily living and sports, and current function of the knee.~The IKDC Subjective Knee Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100. The transformed score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms."|MACI00206 Baseline and Week 260|64 of the 65 MACI-treated patients and 59 of the 63 microfracture-treated patients enrolled in MACI00809 completed the IKDC form at Week 260.|||units on a scale||Full Range|Mean
1401505|NCT01251588|Secondary|Change From MACI00206 Baseline in the Remaining 3 Subscales (Activities of Daily Living, Quality of Life, and Other Symptoms) of KOOS|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline and Week 260|Analysis population includes all participants who completed each KOOS subscale at Week 260.|||units on a scale||Full Range|Mean
1401506|NCT01251588|Secondary|Average Time to Treatment Failure|"ANALYSIS NOT DONE: The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. The number of per protocol treatment failures in each treatment group are reported here.~Patients were considered as a treatment failure if all of the following 5 criteria were met:~Patient’s global assessment of their knee joint compared to Baseline was the same or worse~Physician’s global assessment of the patient’s knee joint compared to Baseline was the same, worse, or significantly worse.~Percent improvement from Baseline in KOOS Pain score was less than 10%.~Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.~The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or ACI."|Up to 260 weeks||||Participants|||Count of Participants
1401507|NCT01251588|Secondary|The Proportion of Patients in Each Treatment Group Assessed as Treatment Failures|"Patients were considered as a treatment failure if all of the following 5 criteria were met:~Patient's global assessment of their knee joint compared to Baseline was the same or worse~Physician's global assessment of the patient's knee joint compared to Baseline was the same, worse, or significantly worse.~Percent improvement from Baseline in KOOS Pain score was less than 10%.~Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.~The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or ACI."|Years 2 through 5 post treatment (MACI or microfracture)||||Participants|||Count of Participants
1401508|NCT01251588|Secondary|Proportion of Patients Who Achieve at Least a 10-point Improvement From MACI00206 Baseline in KOOS Pain and Function (Sports and Recreational Activities) Scores|A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from MACI00206 Baseline scores.|Up to week 260||||Participants|||Count of Participants
1401509|NCT01251588|Secondary|Magnetic Resonance Imaging (MRI) Assessments of Degree of Defect Fill|MRI was assessed by the independent blinded evaluators by means of consensus. The number of participants with a degree of defect fill of >50% is reported.|Week 260|all participants with an MRI at Week 260|||Participants|||Count of Participants
1401510|NCT01251588|Secondary|Change From MACI00206 Baseline for the Participant's KOOS Pain and Function (Sports and Recreational Activities) Scores|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline and Week 260|Analysis population includes all participants who completed each KOOS subscale at Week 260.|||units on a scale||Full Range|Mean
1401511|NCT01251588|Primary|Change From MACI00206 Baseline for the Participant's Knee Injury and Osteoarthritis Outcome (KOOS) Pain and Function (Sports and Recreational Activities) Scores.|The KOOS is a validated knee-specific instrument developed to assess the patients' opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|MACI00206 Baseline to Week 156|The analysis population (n=128) consists of a subpopulation of participants enrolled in the SUMMIT study (n=144). 65 of 65 MACI treated patients and 57 of 63 microfracture-treated patients completed the KOOS at Week 156.|||units on a scale||Full Range|Mean
1401512|NCT01251380|Secondary|Mean Change From DB Baseline in the PedsQL Score (Generic Core Scores) at Each Study Visit Except Week 4|"The PedsQL is a validated quality of life questionnaire, designed for children from 2 to 18 years of age. The Generic Core Scale covers four multidimensional scales including physical, emotional, social and school aspects, with three summary scales of total scale score, physical health summary score and psychosocial health summary score.~Each generic core scale was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems).~A scale score was only calculated if at least 50% of the associated items were non-missing."|Baseline and Week 12|ITT population where n represents number of subjects with data. For Treatment Cycle 4, Week 12 was not included in the study design. Subjects who completed the study or withdrew were counted as missing at subsequent visits. PHS = pyschosocial health summary; W12 = Week 12.|||units on a scale||Standard Deviation|Mean
1401513|NCT01251380|Secondary|Mean Change From DB Baseline in the PedsQL Score (CP Module Scores) at Each Study Visit Except Week 4|"The PedsQL has a disease specific CP module that is relevant to the study population and complements the core modules.~The 35-item questionnaire encompassed 7 scales including (1) daily activities (2) school activities (3) movement and balance (4) pain and hurt (5) fatigue (6) eating activities and (7) speech and communication. A 5-point scale was utilised for parent proxy-report: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem.~Each CP score was calculated as follows: (1) Individual item scores were reversed and transformed from a 0-4 scale to a 0-100 scale by assigning 0=100, 1=75, 2=50, 3=25 and 4=0; (2) Each scale score was calculated as the sum of the transformed individual item scores, divided by the number of non-missing items. Higher scores indicated better quality of life (fewer symptoms or problems).~A scale score was only calculated if at least 50% of the associated items were non-missing."|Baseline and Week 12|ITT population where n represents number of subjects with data. For Treatment Cycle 4, Week 12 was not included in the study design. Subjects who completed the study or withdrew were counted as missing at subsequent visits.|||units on a scale||Standard Deviation|Mean
1401514|NCT01251380|Secondary|Mean Change From DB Baseline in the Observational Gait Scale (OGS) Total Score of the (Most) Affected Leg|"The OGS is a measurement tool used to objectively quantify positive and negative features (impairments) of the upper motor neurone syndrome. The OGS is useful when children are too young or insufficiently cooperative for instrumented gait analysis. It is based on the Physicians Rating Scale but has some modifications to improve its sensitivity to detect changes following administration of Botulinum Toxin Type A (BTX-A).~The OGS total score was calculated as the sum of the individual question scores for Questions 1 to 7, with the highest possible score being 20. The parameters collected were: knee position in midstance, initial foot contact, foot contact at midstance, timing of heel raise, hindfoot at midstance, base of support and gait assistive devices. Higher scores indicate better gait.~The mean change from baseline (in the DB study) in the OGS total score of the (most) affected leg was derived."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
1401515|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in Y Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The mean change from baseline (prior to the first injection cycle in the hamstrings) in Y was derived from the TS.~Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome).~Catch without release was graded 0 if XV1=XV3, ‘unratable’ spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1.~Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
1401516|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in X Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from baseline (prior to the first injection cycle in the hamstrings) was calculated."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
1401555|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Haematocrit|Blood samples for haematocrit were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of RBC in blood||Full Range|Mean
1402879|NCT01239511|Secondary|Change in Consumption of Short-acting Nitrates From Baseline to All Visits||6 weeks|||||||
1401517|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV3 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from baseline (prior to the first injection cycle in the hamstrings) in XV3 at fast speed was derived."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
1401518|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in XV1 Derived From the TS, in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the knee flexors at the knee joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from baseline (prior to the first injection cycle in the hamstrings) in XV1 at slow speed was derived."|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||degrees||Standard Deviation|Mean
1401519|NCT01251380|Secondary|Mean Change From DB Baseline in Spasticity Grade (Y) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The mean change from baseline (in the DB study) in Y was derived from the TS.~Y was graded according to the following scale: Grade 0 - no resistance throughout passive movement (best outcome); Grade 1 - slight resistance throughout passive movement; Grade 2 - clear catch at precise angle, interrupting passive movement, followed by release; Grade 3 - fatigable clonus (less than 10 sec when maintaining pressure) occurring at a precise angle, followed by release; Grade 4 - unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at a precise angle; Grade 5 - joint immovable (worst outcome).~Catch without release was graded 0 if XV1=XV3, ‘unratable’ spasticity otherwise; catch with 'minimal' release was graded 2 if XV3 was consistent and consistently less than XV1.~Angle 0 = position of minimal stretch of the tested muscle. For Grades 0 and 1, spasticity angle X = 0 by definition."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
1401520|NCT01251380|Secondary|Mean Change From DB Baseline in Spasticity Angle (X) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~X (threshold) was derived as XV1 at slow speed minus XV3 at fast speed and the mean change from DB baseline was calculated."|DB Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
1401521|NCT01251380|Secondary|Mean Change From DB Baseline in Angle of Catch (XV3) Derived From the TS, in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from DB baseline in XV3 at fast speed was derived."|DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
1401522|NCT01251380|Secondary|Mean Change From DB Baseline in Angle of Arrest (XV1) Derived From the Tardieu Scale (TS), in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|"The TS was used to measure spasticity in the GSC at the ankle joint of the (most) affected lower limb.~The Investigator assessed muscle reactions of the tested muscle to passive stretch at two velocities: SLOW = V1: as slow as possible (slower than the rate of natural drop of the limb segment under gravity); FAST = V2 (speed of the limb segment falling under gravity) or V3 (as fast as possible - faster than the rate of natural drop of the limb segment under gravity).~The mean change from DB baseline in XV1 at slow speed was derived."|DB baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||degrees||Standard Deviation|Mean
1402880|NCT01239511|Secondary|Changes in Angina Frequency in Subject's Diary From Baseline to All Visits||6 weeks|||||||
1401523|NCT01251380|Secondary|Mean Goal Attainment Scale (GAS) Score|Individual goals were defined prior to treatment in each treatment period. The GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals were defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. After treatment in each treatment cycle, the GAS for each goal was rated using a defined scale (-2: Much less than expected outcome, -1: Somewhat less than expected outcome, 0: Expected outcome, 1: Somewhat more than expected outcome, and 2: Much more than expected outcome).|Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
1401524|NCT01251380|Secondary|Mean Physician’s Global Assessment (PGA) Score|Global assessment of treatment response based on changes since the first injection in the DB study. PGA Scale of the Treatment Response: Global assessment of treatment response was assessed by asking the Investigator the following question: “how would you rate the response to treatment in the subject’s lower limb(s) since the first injection in the DB study?” Answers were made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).|Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4.|ITT population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
1401525|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in Upper Limb Muscle Groups) in the Mean MAS Score for All Injected Upper Limb Muscle Groups From Treatment Cycle 2 Onwards|Baseline was defined as the value obtained prior to the first injection in the upper limb(s). The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension). No subjects were treated in the upper limb in Treatment Cycle 4.|Baseline and Weeks 4 and 12 of Treatment Cycles 2 and 3.|ITT population where n represents number of subjects with data. Only data from subjects injected in the upper limb muscle groups are presented. TC = Treatment Cycle.|||units on a scale||Standard Deviation|Mean
1401526|NCT01251380|Secondary|Mean Change From Baseline (Prior to the First Injection Cycle in the Hamstrings) in the MAS Score in the Knee Flexors Assessed at the Knee Joint of the (Most) Affected Lower Limb|Baseline was defined as the value obtained prior to the first injection in the hamstrings. The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|Baseline and Weeks 4 and 12 of Treatment Cycles 1 to 3; Baseline and Week 4 of Treatment Cycle 4.|ITT population where n represents number of subjects with data. For Dysport 5 U/kg and 10 U/kg, the actual administered doses in the hamstring of the (most) affected leg were >3 to ≤7.5 U/kg and >7.5 to ≤12.5 U/kg, respectively. Analysis excluded subjects with doses ≤3 or >12.5 U/kg. Only data from subjects injected in the hamstring are presented.|||units on a scale||Standard Deviation|Mean
1401527|NCT01251380|Secondary|Mean Change From Baseline (in the DB Study) in the MAS Score in the GSC Assessed at the Ankle Joint of the (Most) Affected Lower Limb|Baseline for the 'change from DB baseline' was defined as the baseline of Study 141 for all treatment cycles. The Modified Ashworth Scale (MAS) is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. The investigator graded muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|DB baseline; Weeks 4 and 12 of Treatment Cycles 1 to 3; Week 4 of Treatment Cycle 4|Intent-to-treat (ITT) population where n represents number of subjects with data. For Dysport 10 U/kg and 15 U/kg, the actual administered doses in the GSC of the (most) affected leg were >7.5 to ≤12.5 U/kg and >12.5 to ≤17.5 U/kg, respectively, in the OL study. The analysis excluded subjects with doses ≤7.5 or >17.5 U/kg.|||units on a scale||Standard Deviation|Mean
1401528|NCT01251380|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Reported in the Double Blind (DB) + Open Label (OL) Period.|Adverse events (AEs) were monitored from the time of informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports.|From baseline (Day 1) until end of study (Week 40) of Cycle 1 and up to Week 28 of Cycles 2 to 4.|Safety Population - all enrolled subjects. One subject received placebo in the DB study and two treatment cycles of Dysport in the OL study. However, as both Dysport treatments were outside of the ranges specified (≤7.5 U/kg in Treatment Cycle 1 and Treatment Cycle 2), the subject was excluded from the analysis (no TEAEs reported for this subject).|||participants|||Number
1401529|NCT01251367|Secondary|Use of Walking Aids/Orthoses at Baseline and Week 4|Subjects were assessed on their use of walking aids and orthoses at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW visit. Outcome measure is reported per cycle at baseline and Week 4. Number of subjects with no walking aid/orthoses were included in the ‘No Walking Aid’ category and number of subjects with any kind of walking aid/orthosis (including single point cane, tripod cane, ankle foot orthosis or other type of walking aid/orthosis) were combined into the ‘Walking Aid’ category.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Participants|||Count of Participants
1401551|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)|Blood samples were taken at baseline, at Week 4, and at the EOS/EW for analysis of the following clinical chemistry parameters: ALP, GGT, SGOT and SGPT. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||IU/L||Full Range|Mean
1401530|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed)|Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401531|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the Soleus Muscle (Knee Flexed)|Spasticity in the treated limb was assessed using the TS for the soleus muscle (knee flexed). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Degrees||Standard Deviation|Mean
1401532|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended)|Spasticity in the treated limb was assessed using the TS for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 =No resistance throughout passive movement, 1=slight resistance throughout passive movement, 2=clear catch at precise angle, interrupting passive movement, followed by release, 3=fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release. 4=unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. Spasticity grade (Y) was recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Mean changes in spasticity grade (Y) from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401533|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the GSC (Knee Extended)|Spasticity in the treated limb was assessed using the Tardieu Scale (TS) for the GSC (knee extended). The TS is administered by applying passive stretch to a muscle group at two velocities. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest, either due to subject discomfort or a mechanical resistance. The same movement is repeated at high velocity (as fast as possible) to determine the angle of catch and release. The angle of movement arrest at slow velocity (XV1) and the angle of catch at fast speed (XV3) were recorded at baseline, at Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The spasticity angle (X) was calculated as the difference between XV1 and XV3. Mean changes in Angles XV1, XV3 and X from baseline to Week 4 are reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Degrees||Standard Deviation|Mean
1401534|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Cadence|All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of cadence were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||steps/s||Standard Deviation|Mean
1401535|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Step Length|All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of step length were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||m/step||Standard Deviation|Mean
1401536|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Walking Speed (WS)|All WS tests were conducted without walking aids over a distance of 10 metres at both a comfortable WS and at maximal WS. Evaluations of WS were made barefoot and with shoes on, at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||metres/second (m/s)||Standard Deviation|Mean
1402881|NCT01239511|Secondary|Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit||6 weeks|||||||
1401537|NCT01251367|Secondary|Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL|Subjects were asked to complete the EQ-5D-5L QoL questionnaire prior to the study treatment at baseline, at Week 4 and at EOS/EW visit. The EQ-5D-5L index is a generic preference based measure of health related QoL producing utility scores that represent subject preferences for particular health states. This instrument rated subject health state looking at 5 specific dimensions such as mobility, self-care, usual activity, pain/discomfort and anxiety/ depression and scored their general health state. Each dimension has 5 levels of severity: no problems, slight problems, moderate problems, severe problems and extreme problems, rated from 1 to 5 (best to worst). In addition, a visual analogue scale (VAS) ranging from 0 to 100 was also included for the patients to summarize their overall health status, where 0 is the worst and 100 the best possible health state. The mean change in pain and discomfort and VAS scores from baseline to Week 4 are reported.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401538|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL)|Subjects were asked to complete the SF-36 health surveys prior to the study treatment at baseline, at Week 4 and at the EOS/EW visit. The SF-36 is a generic non preference based health status measure. This instrument assessed subject health across 8 variable dimensions, which are specific health domains such as physical functioning, social functioning and vitality. Each variable item score is coded and turned into a 0–100 scale where 0 indicates the worst and 100 indicates the best possible health state for both the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the questionnaire. The mean change in the PCS and MCS from baseline to Week 4 are reported.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401539|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in Lower Limb Pain|The intensity of lower limb pain in the treated limb was evaluated by the subject using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: ‘no pain’ (circle with no red shading and scored as 0) and ‘pain as bad as it could be’ (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained at baseline, Weeks 4 and 12 after each Dysport® injection, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at the EOS/EW. The mean changes from baseline in subjects with a baseline SPIN Score >0 at Week 4 was reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401540|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended|Range of active dorsiflexion of the ankle joint of the treated limb, measured using a goniometre, both with the knee flexed (90°) and extended, was used to assess treatment response. The measurements were obtained at the end of baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Degrees||Standard Deviation|Mean
1401541|NCT01251367|Secondary|Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4|An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The investigator rated the response to treatment in the subject’s lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a nine point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The percentage of responders with a PGA score of +1 or greater are reported at Week 4.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of participants|||Number
1401542|NCT01251367|Secondary|Physician's Global Assessment (PGA) of Treatment Response at Week 4|An assessment of overall treatment response was conducted by the investigator at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle and at EOS/EW. The investigator rated the response to treatment in the subject’s lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a nine-point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores per cycle at Week 4 were reported.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401552|NCT01251367|Primary|Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets|Blood samples for WBC count with differentials (neutrophils, lymphocytes) and platelet count were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Giga cells/L||Full Range|Mean
1401553|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV)|Blood samples for MCV were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Femtolitres (fL)||Full Range|Mean
1401543|NCT01251367|Secondary|Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the Soleus Muscle (Knee Flexed) at Week 4|Muscle tone in the treated limb was assessed by MAS in the soleus muscle (with the knee flexed) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of participants|||Number
1401544|NCT01251367|Secondary|Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as the percentage of subjects with at least a 1 grade reduction or 2 grades reduction in MAS score at Week 4.|Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||percentage of participants|||Number
1401545|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed)|Muscle tone in the treated limb was assessed by MAS in the soleus muscle (with the knee flexed) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401546|NCT01251367|Secondary|Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 4 and 12, at discretionary visits at Weeks 16, 20 and 24 of each cycle, and at EOS/EW. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. Outcome measure is reported per cycle as mean change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||units on a scale||Standard Deviation|Mean
1401547|NCT01251367|Primary|Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG)|12-lead ECG tracing was performed at baseline, at Week 4 of each cycle and at EOS/EW. The 12-lead ECG recordings were performed at a paper speed of 25 millimetres/second (mm/s), recorded with the subject in a supine position after 5 minutes rest. The ECG parameters; QT Duration, QT interval corrected with Fridericia’s method (QTcF), QT interval corrected with Bazett’s method (QTcB), QRS duration and PR duration were recorded and outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population.|||Milliseconds (ms)||Standard Deviation|Mean
1401548|NCT01251367|Primary|Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport®|Blood samples were collected at baseline, Week 4 and at EOS/EW to test for the presence of BTX-A antibodies. The number of subjects who were either NAb positive at baseline or negative at baseline but then positive following injection of Dysport® were reported.|At Week 4|Subjects who received at least one open label injection of Dysport® were included in this analysis population. In addition, the antibody analysis included subjects who had an antibody assessment at baseline and at a post baseline visit (n=343).|||Participants|||Count of Participants
1401549|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose|Blood samples for analysis of BUN and fasting blood glucose levels were taken at baseline, at Week 4 and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||millimole/L (mmol/L)||Full Range|Mean
1401550|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine|Blood samples for clinical chemistry analysis of total bilirubin and creatinine were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Micromole/L (μmol/L)||Full Range|Mean
1401556|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC)|Blood samples for haemoglobin and MCHC were taken at baseline, at Week 4, and at the EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||grams (g)/L||Full Range|Mean
1401557|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count|Blood samples for RBC count were taken at baseline, at Week 4, and at EOS/EW. Outcome measure is reported per cycle as change from baseline at Week 4.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Tera cells/Litre (L)||Full Range|Mean
1401558|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Heart Rate (HR)|HR was recorded at baseline and at each subsequent study visit. HR was measured with the subject in a sitting position after resting for 3 minutes. Mean change in HR from baseline at Week 4 is reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Beats per minute (bpm)||Full Range|Mean
1401559|NCT01251367|Primary|Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP)|Systolic and diastolic BP were recorded at baseline and at each subsequent study visit. BP was measured with the subject in a sitting position after resting for 3 minutes. Mean change in BP from baseline at Week 4 is reported per cycle.|Baseline and Week 4 of each cycle|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||Millimetres Mercury (mmHg)||Full Range|Mean
1401560|NCT01251367|Primary|Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs)|Adverse events (AEs) were monitored from the time that the subject gave informed consent to the end of the study/early withdrawal (EOS/EW). An AE was reported as a TEAE if it was not present prior to study treatment administration in Study 140, or if it was present prior to study treatment in Study 140 but the intensity increased during the treatment phase of this study. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any AE that was assessed as a hypersensitivity reaction. TEAEs, treatment related TEAEs, severe TEAEs, TEAEs leading to death, TEAEs leading to withdrawal, treatment emergent AESIs, and serious adverse events (SAEs) are summarised by treatment cycle.|Up to EOS (maximum duration of 52 weeks).|Subjects who received at least one open label injection of Dysport® were included in this analysis population. The number of subjects with data available for analysis at each treatment cycle are reported.|||participants|||Number
1401561|NCT01251354|Secondary|Determination of Overall Survival in This Patient Population|Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.|2 years after the last patient enrolled|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
1401562|NCT01251354|Secondary|Determination of Duration of Response in This Patient Population|Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
1401563|NCT01251354|Secondary|Determination of Overall Response Rate (ORR) in This Patient Population|Overall Response Rate (ORR): Defined as the sum of CR and PR.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
1401564|NCT01251354|Secondary|Determination of Progression Free Survival (PFS) in This Patient Population|Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
1401565|NCT01251354|Secondary|Determination of Time to Progression (TTP) in This Patient Population|Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.|After the last enrolled patient has been followed for at least 6 months or has progressed or died|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
1401566|NCT01251354|Secondary|Number of Participants With Adverse Events||Up to 28 days after last dose|All Screened Population|||participants|||Number
1401567|NCT01251354|Primary|Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)|"CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.~PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|12 weeks|The study was terminated early and due to the low number of patients enrolled, data was not collected/analysed for this endpoint||||||
1401568|NCT01251315|Primary|Intracellular Glutathione Level|Mean intracellular glutathione level every 2 hour|6 hours|Intention-to-treat|||µmol/L||Standard Deviation|Mean
1402882|NCT01239511|Secondary|Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit||6 weeks|||||||
1402883|NCT01239511|Secondary|Change in Time to Onset of Angina From Baseline to the Final Visit||6 weeks|||||||
1401569|NCT01251315|Secondary|Augmentation Index|"Augmentation index (%) is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection if appropriate augmentation index has been shown to be a predictor of adverse cardiovascular events in a high risk patient populations,higher augmentation index is associated with target organ damage. Absolute change of augmentation index from baseline to 6 hours will be estimated for the analysis."|Baseline and 6 hours||||percentage of the central pulse pressure||Standard Deviation|Mean
1401570|NCT01251276|Secondary|Percentage of Participants With One or More Serious Adverse Experiences|A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.|Up to Month 1 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
1401571|NCT01251276|Secondary|Percentage of Participants With One or More Systemic Adverse Experiences|The percentage of participants with one or more systemic adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
1401572|NCT01251276|Secondary|Percentage of Participants With One or More Injection-site Adverse Experiences|The percentage of participants with one or more injection-site adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
1401573|NCT01251276|Secondary|Percentage of Participants Who Discontinued the Study Due to an Adverse Experience|The percentage of participants who discontinued the study due to an adverse experience was assessed.|Up to Month 7|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
1401574|NCT01251276|Secondary|Percentage of Participants With One or More Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.|Up to Day 15 after challenge dose|Participants who received a challenge dose and had safety follow-up|||Percentage of participants|||Number
1401575|NCT01251276|Primary|Percentage of Seroresponders Before and After the Challenge Vaccination|A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.|Predose (Day 1) and 1 month after challenge dose (Month 1)|Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation|||Percentage of participants||95% Confidence Interval|Number
1401576|NCT01251146|Secondary|Number of Participants Compliant With Study Treatment|Participants compliant with study treatment were the participants who have completed the study treatment regimen.|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|ITT population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1401577|NCT01251146|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition|Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)|Safety population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1401578|NCT01251146|Secondary|Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6|Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1401579|NCT01251146|Secondary|Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment|Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)|ITT population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1401580|NCT01251146|Secondary|Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."|||ratio||Standard Deviation|Mean
1401581|NCT01251146|Secondary|Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up|Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."|||millisecond square (ms^2)||Standard Deviation|Mean
1401582|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.|Baseline and end of follow-up (Week 4 or Week 6 or Week 8)|"ITT population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure."|||millisecond per millimeter of mercury||Standard Deviation|Mean
1401583|NCT01251146|Primary|Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal|Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).|Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)|"Intention to treat (ITT) population included all randomized participants who received at least 1 dose of study medication. N signifies those participants who were evaluated for this measure. n signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively."|||millisecond per millimeter of mercury||Standard Deviation|Mean
1401584|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401585|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in European Quality of Life-5D (EQ-5D) Score|EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401586|NCT01251120|Secondary|Change From Baseline to Months 6 and 12 in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline and Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401587|NCT01251120|Secondary|Percentage of Participants Achieving Remission at Months 6 and 12 Assessed Using Clinical Activity Disease Index (CDAI)|The CDAI is a purely clinical index to measure disease activity. The index includes swollen and tender joint counts, participant global assessment of disease activity, and evaluator global assessment of disease activity (EGA).|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401588|NCT01251120|Secondary|Percentage of Participants Achieving Responses According to American College of Rheumatology (ACR) Criteria|The ACR definition of response includes tender and swollen joint counts, VAS scales for pain, participant and investigator global assessment of disease activity, participant-assessed disability using Health Assessment Questionnaire (HAQ) and acute phase response.|Months 6 and 12|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401589|NCT01251120|Secondary|Percentage of Participants Achieving Disease Remission at Month 6 Assessed Using DAS28|"The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. For this study ESR was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:~DAS28 = 0.56 × √(TJC) + 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant’s global assessment of disease activity (100-mm VAS). DAS28 ≤ 2.6 defined remission."|Month 6|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401590|NCT01251120|Secondary|Number of Hours Absent From Work|Work productivity measures include absence from work (participant reported and registries), permanent work disability (pension, participant reported and registries), presenteeism (Quantity and Quality instrument, QQ).|Baseline and 6 and 12 months|Because of the limited number of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401609|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401591|NCT01251120|Primary|Percentage of Participants Achieving Disease Remission at Month 12 Assessed Using the Disease Activity Score Based on 28-Joint Count (DAS28)|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts (SJC and TJC), acute phase response, and general health status. For this study Erythrocyte sedimentation Rate (ESR) was to be used to calculate DAS28 score. The DAS28, which uses a 28 joint count, is derived from the original DAS which includes a 44 swollen joint count. The DAS28 has been validated in RA. The index is calculated using the following formula:~DAS28 equals (=) 0.56 times (×) square root of √(TJC) plus (+) 0.28 × √(SJC) + 0.70 × ln(ESR) + 0.014 × GH Where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, ESR measured as millimeters per hour (mm/hr), and GH = general health, which is participant’s global assessment of disease activity (100-mm Visual Analog Scale [VAS]). DAS28 less than/equal to (≤) 2.6 defined remission."|Month 12|Because of the limited number (n) of participants (n=2), the study was terminated prematurely. No statistical analysis could be performed.||||||
1401592|NCT01251042|Secondary|Frequency of Allogenic Blood Transfusion||Up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||percentage of participants|||Number
1401593|NCT01251042|Secondary|Mean Blood Loss Volume|Estimated blood loss during and after surgery.|After surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||ml||Full Range|Mean
1401594|NCT01251042|Secondary|Interferon Gamma (IFN-γ) Concentration|Systemic IFN-γ concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
1401595|NCT01251042|Secondary|Tumor Necrosis Factor Alpha (TNF-α) Concentration|Systemic TNF-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
1401596|NCT01251042|Secondary|Interleukin-10 (IL-10) Concentration|Systemic IL-10 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
1401597|NCT01251042|Secondary|Interleukin-8 (IL-8) Concentration|Systemic IL-8 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
1401598|NCT01251042|Secondary|Interleukin-6 (IL-6) Concentration|Systemic IL-6 concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
1401599|NCT01251042|Secondary|Interleukin-1-alpha (IL-1-α) Concentration|Systemic IL-1-α concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||pg/ml||Standard Deviation|Mean
1401600|NCT01251042|Primary|Difference in Plasma Free Hemoglobin (p-Hb) Concentration|Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery|At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||g/l||Standard Deviation|Mean
1401601|NCT01251042|Secondary|Creatinine Concentration|Systemic creatinine concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||μmol/l||Standard Deviation|Mean
1401602|NCT01251042|Secondary|Potassium Concentration|Systemic potassium concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||mmol/l||Standard Deviation|Mean
1401603|NCT01251042|Secondary|Hemoglobin Concentration|Systemic hemoglobin concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||g/dl||Standard Deviation|Mean
1401604|NCT01251042|Secondary|Plasma Free Hemoglobin (p-Hb) Concentration|Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.|At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)|All subjects randomized.|||g/l||Standard Deviation|Mean
1401605|NCT01250990|Primary|Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin|Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.|Baseline and 12 weeks|Of the 22 subjects enrolled, only subjects who completed the baseline and 12 week reverse cholesterol transport studies were included in the final outcome analysis.|||%/mol/h||95% Confidence Interval|Mean
1401606|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401607|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401608|NCT01250925|Primary|Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401611|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401612|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401613|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401614|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed the study visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401615|NCT01250925|Secondary|Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events|The safety analysis will be based on slit-lamp findings, corrected visual acuity (Snellen) and adverse events (if any). No inferential statistical analyses are planned for any safety variable.|Six weeks|Participants who completed the study visits were analyzed.|||participants|eyes||Number
1401616|NCT01250925|Primary|Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)|The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.|Six weeks|Participants who completed all visits were analyzed.|||cells/mm2|eyes|Standard Error|Mean
1401617|NCT01250899|Primary|Success Rate in Achieving a 25(OH)D Level ≥30ng/mL After 12 Weeks of Oral Vitamin D Supplementation.|Percentage of participants successfully repleted to 25(OH)D ≥30ng/mL after 12 weeks of oral vitamin D supplementation.|12 weeks|After 12 weeks of oral vitamin D supplementation, serum 25(OH)D levels were measured in the Vitamin D Insufficient arm. 81% (n=66) of insufficient persons achieved 25(OH)D ≥30ng/mL (p=0.32 vs. historical controls).|||percentage of participants||95% Confidence Interval|Number
1401618|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the ortho-hydroxyatorvastatin concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1401619|NCT01250834|Secondary|Pharmacokinetics of Ortho-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1401620|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the para-hydroxyatorvastatin concentration-time curve from time 0 to infinity. The outcome is not available for this metabolite since the terminal elimination phase was not determinable.|Pre-dose to 56 hours post-dose|No participants were analyzed for this outcome measure since the terminal elimination phase was not determinable.||||||
1401621|NCT01250834|Secondary|Pharmacokinetics of Para-Hydroxyatorvastatin: Maximum Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1401622|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Area Under the Curve (AUC)|This measure is based on the pharmacokinetic area under the atorvastatin plasma concentration-time curve from time 0 to infinity.|Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1401623|NCT01250834|Primary|Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax)||Pre-dose to 56 hours post-dose|All randomized participants who received at least 1 dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1401624|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401625|NCT01250769|Secondary|Gingival Bleeding Index|Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401626|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|28 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401627|NCT01250769|Secondary|Modified Gingival Index|Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401629|NCT01250769|Primary|Residual Protein Concentration|Residual protein concentration of interproximal plaque samples|14 days|Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.|||ug/mL||95% Confidence Interval|Least Squares Mean
1401630|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.|||Percentage of participants|||Number
1401631|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.|||Percentage of participants|||Number
1401632|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction.|||Percentage of participants|||Number
1401633|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
1401634|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
1401635|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
1401636|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic event. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||Percentage of participants|||Number
1401637|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 3|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.|||Percentage of participants|||Number
1401735|NCT01250119|Primary|Percentage of Participants With EGFR Mutations by Subgroup|Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.|14 Days|Only participants with a valid EGFR mutations test result were included in the analysis.|||percentage of participants|||Number
1401638|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 2|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.|||Percentage of participants|||Number
1401639|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Catch-up Dose 1|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction.|||Percentage of participants|||Number
1401640|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
1401641|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
1401642|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
1401643|NCT01250756|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||Percentage of participants|||Number
1401644|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1402884|NCT01239511|Primary|Change in Total Exercise Time (Seconds)|the time difference of total exercise time from V2 to V5 compare to placebo|6 weeks after the first exercise tolerance testing is conducted|ITT (intend-to-treat) population will be used for analysis|||second||Standard Deviation|Least Squares Mean
1401645|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the catch-up dose 3|Catch-up immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1401646|NCT01250756|Secondary|Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose|Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|Pre-toddler dose, 1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||Fold Rise||95% Confidence Interval|Geometric Mean
1401647|NCT01250756|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1401648|NCT01250756|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1401649|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
1401650|NCT01250756|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1401651|NCT01250756|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity set: eligible participants who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1401652|NCT01250756|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1401653|NCT01250756|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1401654|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series|GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
1401655|NCT01250756|Primary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series|Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1401656|NCT01250756|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1401657|NCT01250730|Primary|Metabolite to Parent Ratio Cmax|The metabolic ratio (MR) is calculated by first converting the Cmax for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ratio||Standard Deviation|Geometric Mean
1401658|NCT01250730|Primary|Metabolite to Parent Ratio AUClast|The metabolic ratio (MR) is calculated by first converting the AUClast for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ratio||Standard Deviation|Geometric Mean
1401659|NCT01250730|Primary|Metabolite to Parent Ratio AUC(0-inf)|The metabolic ratio (MR) is calculated by first converting the AUC(0-inf) for both crizotinib and metabolite (PF-06260182) from mass units to molar units.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ratio||Standard Deviation|Geometric Mean
1401660|NCT01250730|Primary|Time to Cmax (Tmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Full Range|Median
1401661|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Plasma Active Metabolite (PF-06260182)||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Standard Deviation|Geometric Mean
1401662|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Plasma Active Metabolite (PF-06260182)|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
1401663|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUC0-inf) of Plasma Active Metabolite (PF-06260182)|"AUC(0-inf) of PF-06260182 is estimated from the PF-06260182 concentration. It is obtained from AUClast plus (Clast/kel).~AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.~Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
1401664|NCT01250730|Primary|Dose Normalized Cmax of Crizotinib|Dose normalized (to 150 mg dose) Cmax is obtained from Cmax / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Standard Deviation|Geometric Mean
1401665|NCT01250730|Primary|Dose Normalized AUClast of Crizotinib|Dose normalized (to 150 mg dose) AUClast is obtained from AUClast / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
1401666|NCT01250730|Primary|Dose Normalized AUC(0-inf) of Crizotinib|Dose normalized (to 150 mg dose) AUC(0-inf) is obtained from AUC(0-inf) / (Dose/150).|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
1401667|NCT01250730|Primary|Apparent Volume of Distribution (Vz/F) of Crizotinib|"Vz/F of crizotinib is obtained from a Dose / (AUCinf *kel).~Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||Liter||Standard Deviation|Geometric Mean
1401668|NCT01250730|Primary|Apparent Oral Clearance (CL/F) of Crizotinib|CL/F of crizotinib is obtained from a Dose per AUCinf.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||liter per hour||Standard Deviation|Geometric Mean
1401669|NCT01250730|Primary|Terminal Elimination Half-life (t1/2) of Crizotinib|"t1/2 of crizotinib is the time measured for the plasma concentration to decrease by one half. It is obtained from a Loge(2)/kel.~Kel = terminal phase elimination rate constant"|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||hours||Standard Deviation|Mean
1401670|NCT01250730|Primary|Time to Cmax (Tmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Full Range|Median
1401671|NCT01250730|Primary|Maximum Plasma Concentration (Cmax) of Crizotinib||0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng/mL||Standard Deviation|Geometric Mean
1401672|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Crizotinib|AUClast of crizotinib is estimated from the crizotinib concentration. It is obtained from Linear/Log trapezoidal method.|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
1401673|NCT01250730|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib|"AUC(0-inf) of crizotinib is estimated from the crizotinib concentration. It is obtained from AUClast plus (Clast/kel).~AUClast = area under the plasma concentration-time curve from zero time until the last measurable concentration.~Clast = the last quantifiable concentration. Kel = terminal phase elimination rate constant."|0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 144 hours post-dose||||ng*hr/mL||Standard Deviation|Geometric Mean
1401674|NCT01250717|Primary|Pathologic Complete Response Was Assessed by Rigorous Pathological Examination by One of Two Pathologists|One of two pathologists (SR, EG), assigned the Gleason scores for each patient from pre-treatment prostate biopsies and assessed pathological staging on post- prostatectomy specimens. Staging including a description of all tumor foci within the gland, presence or absence of perineural invasion and/or lymphovascular invasion, presence of extraprostatic extension of tumor (including seminal vesicle invasion), and margin status. The pathologists reviewed the presence or absence of cancer in each prostate gland removed on the study patients. RECIST has to my knowledge not been used for pathological examination in neoadjuvant studies. 0 out of 28 participants acheived complete response. RECIST is not appropriate as cancer within the gland at the time of treatment is not measurable by RECIST. The primary outcome is a pathological complete response.|status post prostectomy||||participants|||Number
1401675|NCT01250509|Secondary|Change in Psychological Stress (Baseline and 4 Months)|The 10-item Perceived Stress Scale was used to evaluate perception of stressful events over the past month by using a 5-point Likert scale (0 = never to 4 = very often) (Cohen et al., 1983). The mean of the ten items was used in analysis. Higher scores indicate greater perceived stress.|Change from Baseline in Psychological Stress|An intention-to-treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.|||units on a scale||Standard Deviation|Mean
1401676|NCT01250509|Secondary|Telomerase Activity|Cryopreserved peripheral blood nuclear cells (PBMCs) were thawed and live cells counted using a hemocytometer by the Trypan blue exclusion method. For each sample, an extract of 5000 cells per microliter was made and two concentrations, corresponding to 5000 and 10,000 cells, were assayed for each sample to ensure the assay was in the linear range. Telomerase activity was assayed by the Telomerase Repeat Amplification Protocol (TRAP) using a commercial kit (TRAPeze, Telomerase Detection kit, Upstate/ CHEMICON, Temecula, CA). Baseline and post-intervention samples for the same participant were assayed in the same batch and run on the same gel to eliminate any differences caused by reaction or procedural batch-to-batch variations. Technicians were blind to group assignment. Telomerase activity is defined as 1 unit = the amount of product from one 293T cell/10,000 PBMCs, and was quantified using the software ImageQuant 5.2 (GE Healthcare, Piscataway, NJ).|Change from Baseline in Telomerase Activity at 4 months|Intention-to-treat analysis was conducted.|||Standard arbitrary units, see above||Standard Deviation|Mean
1401677|NCT01250509|Secondary|Weight||Change in Weight (baseline and 4 months)|Intention to treat analysis was conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.|||kg||Standard Deviation|Mean
1401678|NCT01250509|Primary|Change in Abdominal Fat|Whole-body dual energy X-ray absorptiometry (DEXA) scans were performed to assess body fat distribution. The DEXA densitometry (GE Healthcare Lunar Prodigy, Madison, Wis, USA) was adjusted to the fan beam mode and EnCore software version 9.15 was used. The primary region of interest was fat tissue from a rectangular region in the abdominal area defined by the upper boundary of the second lumbar vertebra to the lower edge of the fourth lumbar vertebra. The vertical sides were defined as the continuation of the lateral sides of the rib cage.|Change from Baseline in Abdominal Fat (baseline and 4 months)|Intent-to-treat analyses were conducted. Assuming participants lost to followup did not change over time, missing data at postintervention were imputed using preintervention values.|||grams||Standard Deviation|Mean
1401679|NCT01250418|Primary|TcCO2 Above 50|% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.|Intraoperative, an average of about 1 and 1/2 hours.||||Percent time intraoperatrive||Standard Deviation|Mean
1401680|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their second­line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second­line PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1401681|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second­line PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 18|ITT population|||percentage of participants||95% Confidence Interval|Number
1401682|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12|Second­line PFS was defined as the time from randomization to PD or death due to any cause during their second­line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non­progression was documented.|Month 12|ITT population|||percentage of participants||95% Confidence Interval|Number
1402038|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Mean
1401683|NCT01250379|Secondary|Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)|"The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.|||score on a scale||95% Confidence Interval|Mean
1401684|NCT01250379|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)|"The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life."|Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints.|||score on a scale||95% Confidence Interval|Mean
1401685|NCT01250379|Secondary|Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.|||mm||95% Confidence Interval|Mean
1401686|NCT01250379|Secondary|Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)|The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population; n=number of participants who completed the assessment at the specified timepoint.|||mm||95% Confidence Interval|Mean
1401687|NCT01250379|Secondary|Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)|"The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life."|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.|||score on a scale||95% Confidence Interval|Mean
1401688|NCT01250379|Secondary|Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)|The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either “no problems”, “some problems”, or “extreme problems” in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint|||score on a scale||95% Confidence Interval|Mean
1401705|NCT01250379|Primary|Second-Line PFS|The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population|||months||95% Confidence Interval|Median
1404213|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.|LV pacing impedance results were reported for pre-discharge visit|pre-discharge|75 CRT-D patients had data available at pre-discharge|||Ohms||Standard Deviation|Mean
1401689|NCT01250379|Secondary|Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)|The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either “no problems”, “some problems”, or “extreme problems” in the following categories: mobility (M) (“no problems”=“I have no problems in walking about” to “extreme problems”=“I am confined to bed”), self-care (SC) (“no problems”=“I have no problems with self-care” to “extreme problems”=”I am unable to wash or dress myself”), usual activities (UA) (“no problems”=“I have no problems performing my usual activities” to “extreme problems”=“I am unable to perform my usual activities”), pain/discomfort (P/D) (“no problems”=“I have no pain or discomfort” to “extreme problems”=“I have extreme pain or discomfort”), and anxiety/depression (A/D) (“no problems”=“I am not anxious or depressed” to “extreme problems”=‘I am extremely anxious or depressed”).|Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)|ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint.|||percentage of participants|||Number
1401690|NCT01250379|Secondary|Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.|Months 6, 12, 18, and 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1401691|NCT01250379|Secondary|Overall Survival (OS)|OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.|Baseline until death (up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
1401692|NCT01250379|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any reason were reported.|Baseline until death (up to approximately 4 years)|ITT population|||percentage of participants|||Number
1401693|NCT01250379|Primary|Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6|Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Month 6|ITT population|||percentage of participants||95% Confidence Interval|Number
1401694|NCT01250379|Secondary|Time to Second- and Third-Line Tumor Progression|The median time, in months, from randomization to second- and third-line tumor progression. Second­ and third­line tumor progression was defined as third­line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||months||95% Confidence Interval|Median
1401695|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line Tumor Progression|Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||percentage of participants|||Number
1401696|NCT01250379|Secondary|Second- and Third-Line PFS|The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||months||95% Confidence Interval|Median
1401697|NCT01250379|Secondary|Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1|Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years|ITT population|||percentage of participants|||Number
1401698|NCT01250379|Secondary|Third-Line PFS|The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)|Third line ITT population|||months||95% Confidence Interval|Median
1401699|NCT01250379|Secondary|Percentage of Participants With Third-Line PFS According to RECIST v1.1|Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)|Third line ITT population: all randomized participants who received third-line treatment.|||percentage of participants|||Number
1401700|NCT01250379|Secondary|Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)|Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Months 3, 6, and 9|ITT population; only randomized participants with a CR or PR were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1401701|NCT01250379|Secondary|Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)|The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with a CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1401702|NCT01250379|Secondary|Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)|For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1401703|NCT01250379|Secondary|Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)|BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population; only randomized participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1401704|NCT01250379|Secondary|Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)|The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (>) 1.5 ULN, < 65 years of age, ≥ 65 years of age, < 70 years of age, ≥ 70 years of age, < 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free > 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free > 24 months, D-free ≤ 12 months, and D-free > 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.|Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor.|||months||95% Confidence Interval|Median
1402885|NCT01239394|Secondary|Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia|Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)|2 years||||Participants|||Count of Participants
1401706|NCT01250379|Primary|Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)|Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years|Intent-to-Treat (ITT) population - all randomized participants.|||percentage of participants|||Number
1401707|NCT01250210|Primary|Cycle Control|The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.|3 months|ITT population|||number of episodes||Standard Deviation|Mean
1401708|NCT01250210|Primary|Ovulation Suppression in Three Treatment Groups Over 3 Cycles|"Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are:~Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points.~Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points.~Perfect compliance: If no patch has been off >1 day and no more than 1 day has elapsed between patch changes.~Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit."|3 months|ITT, perfect compliance, complete progesterone, verifiable compliance|||%of cycles with possible ovulation|Total number of cycles||Number
1401709|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|12 weeks||||units on a scale||Standard Deviation|Mean
1401710|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|12 weeks||||units on a scale||Standard Deviation|Mean
1401711|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|12 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"|||units on a scale||Standard Deviation|Mean
1401712|NCT01250184|Secondary|Quality of Life SF-36|The SF-36 consists of 36 items addressing the patient's perception of their quality of life (QoL) in the following eight domains: physical function (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH), and one item change in health. Sub-scale scores range from 0 to 100, with 100 as the best, most positive QoL in that area and 0 is the worst. There is a total scale score, all subscales range from 0 to 100. This scale was validated in Colombia.|4 weeks||||units on a scale||Standard Deviation|Mean
1401713|NCT01250184|Secondary|PHQ 9 Function Measured With the Hand Back and Hand Mouth Maneuvers. Complications and Adverse Reactions Need for Rescue Medication|The PHQ-9 was developed from the Primary Care Evaluation of Mental Disorders. The self-report instrument asks individuals how much they had been bothered by any of the nine problems over the prior two weeks. Items are scored from 0 (not at all) to 3 (nearly every day). Items are summed and the total score (from 0 to 27) represents the severity of depressive symptoms. 0 - 4 None-minimal None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe, 20 - 27 Severe|4 weeks||||units on a scale||Standard Deviation|Mean
1401714|NCT01250184|Primary|Visual Analogue Scale|VAS with a score of 0-100, where 100 is the value representing the highest degree of pain and 0 the lowest. Successful treatment was defined as a reduction in pain of at least 20% of the previous score on the VAS after 4 weeks of the initial evaluation, or 14 mm on the VAS; this scale is a reliable pain assessment measure that has been validated previously|4 weeks|"Was calculated with the software Sample Size from Javeriana University, was taken into account an error type I of 0.05 and error type II of 0.2, number of measurements before randomization = 1, after performing scrambling = 2, correlation between measurements of 0.6, clinically important difference of 0.35, for a total number of = 45 each"|||units on a scale||Standard Deviation|Mean
1401723|NCT01250145|Secondary|Part B - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Days 1 - 19 and 34 - 37|All randomized participants who received a patch.|||patches with adhesive score|Participants||Number
1401715|NCT01250171|Secondary|Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were taken in a standing position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance specific to the test charts. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Standard Deviation|Mean
1401716|NCT01250171|Secondary|Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8|Patients were instructed to record each occurrence of a desire for topical lubricant use in a patient diary. The percentage of patients in each of 6 categories (0-5, 6-10, 11-15, 16-20, 21-25, > 25 times) indicating the number of times a patient records a desire for artificial tear use per day was calculated at each time point. The percentage was calculated using the number of patients with any reported data on that day in the respective treatment group as the denominator.|Day 1 and Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Percentage of patients|||Number
1401717|NCT01250171|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8|The OSDI is an instrument for measuring dry eye disease severity and effect on vision-related functions. Patients were asked a series of 12 questions; patients responded to the questions in regard to both eyes. Responses ranged from 0=None of the time to 4=All of the time. OSDI was calculated as the sum of the 12 question scores x 25/number of questions answered. The total score ranged from 0-100. A higher score indicates drier eyes. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Full Range|Mean
1401718|NCT01250171|Secondary|Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8|Conjunctival redness was measured in the study eye at each visit by a masked evaluator. The evaluator compared the patient’s study eye with a set of 5 reference photos showing a normal eye and eyes with various degrees of redness. Redness was scored on a scale of 0-5 with a white normal eye = 0 and an eye with the most redness = 5. A higher score indicates more redness. A negative change score indicates improvement in redness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Full Range|Mean
1401719|NCT01250171|Secondary|Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8|Tear film breakup time was defined as the time of last blink to the appearance of the first growing micelle after instilling 5 μl of non-preserved 2% sodium fluorescein into the lower palpebral conjunctiva of the study eye. Measurement was repeated 3 times and a mean tear film breakup time calculated. A lower score indicates a drier eye. A positive change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Seconds||Full Range|Mean
1401720|NCT01250171|Secondary|Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8|The Schirmer test measures the production of tears. A small strip of filter paper is placed inside the lower eyelid (conjunctival sac) of each eye and the eyes are kept closed for 5 minutes. The paper is removed and the length of paper that is wet is measured as an index of tear production. The amount of tear production in the study eye was ranked on a 4 point scale: 0=Normal (≥ 15 mm wetting of the paper), 1=Mild (14-9 mm wetting of the paper), 2=Moderate (8-4 mm wetting of the paper), and 3=Severe (< 4 mm wetting of the paper). A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Full Range|Mean
1401721|NCT01250171|Secondary|Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of the study eye. Staining was assessed in 3 regions (inferior, superior, and central) of the cornea and rated on a scale of 0 (no staining) to 4 (confluent staining). A mean of the 3 zones was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Weeks 1, 4, and 8|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Standard Deviation|Mean
1401722|NCT01250171|Primary|Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4|Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye. Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining). A mean of the 5 zones for the study eye was calculated. A higher score indicates a drier eye. A negative change score indicates improvement in dryness.|Baseline to Week 4|All patient population: All randomized patients that received 1 full dose of a study drug per protocol. Two patients were not included in the all patient population (1 in each drug group) as they were not dosed per protocol or they did not receive the full dose of the assigned treatment.|||Units on a scale||Standard Deviation|Mean
1401919|NCT01248715|Primary|Number of Participants to Transfer to ICU After 24 h|Number of subjects that were transfered to an intensive care unit (ICU) after 24 hours of hospitalization. A patient transferred to ICU within 24 hours of admission was considered as a direct admission to ICU and not meeting criteria for clinical failure.|24 h||||Participants|||Count of Participants
1401724|NCT01250145|Primary|Part B - Skin Irritation and Sensitization by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).|Days 1 - 19 and 34 - 37|All participants who entered the study and received patches are included in the analysis.|||patches with Draize scores|Participants||Number
1401725|NCT01250145|Secondary|Part A - Patch Adhesion Score|Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to <90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to <75% adhered (less than half of the patch lifting off the skin); Score 3 = >0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).|Day 1 through Day 22|All randomized participants who received a patch.|||patches with adhesive score|Participants||Number
1401726|NCT01250145|Primary|Part A - Cumulative Skin Irritation by Draize Score|Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter [mm]).|Day 1 through Day 22|All participants who entered the study and received patches are included in the analysis.|||patches with Draize scores|Participants||Number
1401727|NCT01250119|Secondary|Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
1401728|NCT01250119|Secondary|Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
1401729|NCT01250119|Secondary|Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
1401730|NCT01250119|Secondary|Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
1401731|NCT01250119|Secondary|Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.|Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population; n = number of participants analyzed at for the given parameter at the specified visit.|||percentage of participants|||Number
1401732|NCT01250119|Secondary|Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument|The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.|Screening, Baseline and Final or Withdrawal Visit up to 34 months|ITT population; number (n) = number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
1401733|NCT01250119|Secondary|Survival Time in Months|Duration of time in months from Screening until Death due to any cause.|Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months|ITT population|||months||95% Confidence Interval|Median
1401734|NCT01250119|Secondary|Probability of Being Alive and Free of Progression by Timepoint|Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.|Months 0, 3, 6, 9, 12, 15, and 18|ITT population|||probability of being alive||95% Confidence Interval|Number
1401736|NCT01250119|Secondary|Percentage of Participants With a Response by Best Objective Tumor Response|Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1”. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months|Intention-to-treat (ITT) population: All participants in the target population who were eligible for treatment and who actually received one dose of treatment.|||percentage of participants|||Number
1401737|NCT01250119|Primary|Percentage of Participants Who Tested Positive for EGFR Mutations|All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.|14 days|Diagnostic population; Only participants who were tested for EGFR mutations were included in the analysis.|||percentage of participants|||Number
1401738|NCT01250054|Primary|Overall Vision|Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week’s wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.|One week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
1401739|NCT01250002|Secondary|Opioid Consumption (Morphine Equivalents)|opioid consumption (morphine equivalents)post operatively|24 hours||||mg||Full Range|Median
1401740|NCT01250002|Primary|Quality of Recovery 40 Score|Quality of recovery 40 score on the day after surgery. Scale ranges from a low of 40 (poor recovery) to a high of 200 (good recovery).|24 hours post surgery|Intent to treat.|||units on a scale||Full Range|Median
1401741|NCT01249872|Secondary|Change From Baseline of Spirometric Values|Preoperatively, after a detailed demonstration, baseline spirometry measurements of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) were measured, using a bedside spirometer (PowerCubeΤΜ, Ganshorn Medizin Electronic, Germany), on-line connected to a PC. Spirometry was standardized with each patient in a 30o head-up position and it was performed at least three times and the best measurement was recorded, according to the criteria of the European Respiratory Society .Postoperatively, spirometric values (FVC= Forced Vital Capacity, FEV1=Forced Expiratory Volume at 1 sec , PEFR= Peak Expiratory Flow Rate)were recorded at 12, 24, 36, 48, 72, 144 hours . Data are expressed as percentage of preoperative values, which are 100%.|up to 6th day postoperatively||||percentage of preoperative values||Standard Deviation|Mean
1401742|NCT01249872|Secondary|Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively|Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 1mg(groups B and E)or 2mg (groups C and F) and as continuous infusion of 0,2mg/h ( all groups) at 24h and 48h postoperatively.All participants in each Group received the same dose of epidural morphine, as no participant missed a scheduled dose.|up to 48 hours postoperatively||||mg||Standard Deviation|Mean
1401743|NCT01249872|Secondary|Consumption of Levobupivacaine at 24h and 48 h Postoperatively|Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively|up to 48 hours postoperatively||||mg||Standard Deviation|Mean
1401744|NCT01249872|Secondary|Time to First Postoperative Ambulation|Time to being able to walk without assistance within the room or outside the room|up to 6 days||||hours||Standard Deviation|Mean
1401745|NCT01249872|Secondary|Time to Postoperative Bowel Recovery|Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient|up to 6 days||||hours||Standard Deviation|Mean
1401746|NCT01249872|Primary|Change From Baseline in Pain Scores (Visual Analogue Scale)|Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.|up to 48 h postoperatively|The sample size was chosen in order to detect a difference in the epidural levobupivacaine PCEA consumption at 48 hrs. We calculated that 14 patients per group would be adequate to detect statistical significance (α = 0.05, power = 90%), using data from a previous pilot study Then, we increased the sample size by 15%.|||units on a scale||Standard Deviation|Mean
1401747|NCT01249833|Other Pre-specified|Change in Mood Assessment|"Mood was assessed using the Bond-Lader 10 cm (100 mm) visual analogue scales for mood (16 scales in total); factored for alertness (mean of 9 scales), calmness (mean of 2 scales) and contentment (mean of 5 scales).~The range in score for each scale and for each factor (alertness, calmness and contentment) was 0 - 100 mm.~Each scale was anchored such that the lower the value, the better the mood."|Change from baseline at Day 4|All randomised subjects with data collected at both Baseline and Day 4. Baseline data was available for all randomized subjects in both groups; Day 4 data was available for 54 of 59 randomized subjects in the Oseltamivir Group (54 analysed) and for 58 of 63 randomized subjects in the Standard of Care Alone Group (58 analysed).|||millimeter||Standard Error|Least Squares Mean
1401748|NCT01249833|Secondary|Change in Processing Speed Assessment|"Processing speed assessed with the animal number decoding subtest~The lower the value, the better the processing speed"|Change from baseline at Day 4|All randomized subjects for whom data was collected at both Baseline and Day 4. Oseltamivr Group: Baseline data available for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline data available for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed).|||Millliseconds||Standard Error|Least Squares Mean
1401749|NCT01249833|Secondary|Change in Working Memory Assessment|"Working memory assessed with the Dot Memory Test.~The higher the value, the better the working memory."|Change from baseline at Day 4|All randomised subjects with data collected at both Baseline and Day 4. Oseltamivir Group: Baseline values collected for all randomized subjects (59); Day 4 data available for 54 subjects (54 analysed). Standard of Care Alone Group: Baseline values collected for all randomized subjects (63); Day 4 data available for 58 subjects (58 analysed)|||Number of correct answers||Standard Error|Least Squares Mean
1401750|NCT01249833|Primary|Change in Attention Assessment|"Attention assessed using simple reaction time measured in milliseconds. Simple reaction time calculated as the mean of the following 2 sub-tests:~Reaction Time Subtest~Cued Reaction Time Subtest~The lower the value, the better the attention."|Change from baseline at Day 4|All randomised subjects for whom data was collected at both baseline and Day 4. Oseltamivir group: baseline data available for 58 of 59 randomised subjects and Day 4 data for 53 subjects (53 subjects analysed). Standard of Care Alone group: baseline data available for 61 of 63 subjects and Day 4 data for 55 subjects (55 subjects analysed).|||milliseconds||Standard Error|Least Squares Mean
1401751|NCT01249664|Secondary|Mean Change in Area of Leakage From Baseline at Week 24 - LOCF|A negative change from baseline indicates improvement, ie, less leakage.|Baseline, Week 24||||Disc areas||Standard Deviation|Mean
1401752|NCT01249664|Secondary|Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks||Baseline, Week 24||||Percentage of participants|||Number
1401753|NCT01249664|Secondary|Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline, Week 24||||Scores on a scale||Standard Deviation|Mean
1401754|NCT01249664|Secondary|Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline, Week 24||||Scores on a scale||Standard Deviation|Mean
1401755|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 48||||Disc areas||Standard Deviation|Mean
1401756|NCT01249664|Secondary|Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF|CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes|Baseline, Week 24||||Disc areas||Standard Deviation|Mean
1401757|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 48||||microns||Standard Deviation|Mean
1401758|NCT01249664|Secondary|Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF|A negative number indicates improvement (reduced thickness).|Baseline, Week 24||||microns||Standard Deviation|Mean
1401759|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
1401760|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
1401761|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
1401762|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
1401763|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
1401764|NCT01249664|Secondary|Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
1401765|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
1401807|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period or 3 Months Post Treatment|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 3 months post 12-week trial period|intent-to-treat|||participants who relapsed to cocaine use|||Number
1401766|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
1401767|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 48||||Percentage of participants|||Number
1401768|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
1401769|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
1401770|NCT01249664|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases|Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24||||Letters correctly read||Standard Deviation|Mean
1401771|NCT01249664|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline, Week 24||||Percentage of participants|||Number
1401772|NCT01249664|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.|Baseline, Week 24||||Letters correctly read||Standard Deviation|Mean
1401773|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline to 8 weeks|Full analysis set (96 participants)|||Participants|||Number
1401774|NCT01249651|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn at week 4.|||Participants|||Number
1401775|NCT01249651|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|92 Participants in the Full analysis set (96 participants) had data of heartburn.|||Number of days||Standard Deviation|Mean
1401776|NCT01249651|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1)|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline to 8 weeks|Full analysis set (96 participants)|||Number of days||Standard Deviation|Mean
1401777|NCT01249417|Secondary|Goal Attainment Scale (GAS) Score|GAS is a functional scale used to measure progress towards individual therapy goals. Individual goals defined for each subject by the physician, and the child's parents (caregiver) where applicable, prior to treatment. Post-baseline, the GAS for each goal rated using a defined scale (-2: Much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, 1: somewhat more than expected outcome, and 2: Much more than expected outcome).|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401808|NCT01249274|Post-Hoc|Relapse to Cocaine Use During Treatment Period|Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.|baseline to 12 weeks|intent-to-treat|||participants who relapsed to cocaine use|||Number
1401778|NCT01249417|Secondary|Physician’s Global Assessment (PGA) of the Treatment Response.|PGA Scale of the Treatment Response: Global assessment of treatment response assessed by asking the Investigator the following question: “how would you rate the response to treatment in the subject’s lower limb(s) since the last injection?” Answers will be made on a 9 point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved, +4: markedly improved).|Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401779|NCT01249417|Primary|Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb|The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).|Change from baseline to Week 4|ITT population, defined as all randomised subjects who received at least one injection of study treatment and who had a MAS score in the GSC assessed both at baseline and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401780|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12|The intensity of lower limb pain was evaluated using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: ‘no pain’ (circle with no red shading and scored as 0) and ‘pain as bad as it could be’ (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401781|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)|Range of active dorsiflexion of the ankle joint, both with the knee flexed (90°) and extended (measured by goniometry) was used to assess treatment response. The measurements were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||Degrees||95% Confidence Interval|Least Squares Mean
1401782|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)|The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401783|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)|The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||Degrees||95% Confidence Interval|Least Squares Mean
1401791|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
1401784|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)|The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401785|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)|The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||Degrees||95% Confidence Interval|Least Squares Mean
1401786|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
1401787|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
1401788|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
1401789|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
1401790|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
1401792|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/step||95% Confidence Interval|Least Squares Mean
1401793|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||steps/s||95% Confidence Interval|Least Squares Mean
1401794|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12|Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
1401795|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12|Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
1401796|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
1401797|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1 and 12 are reported.|Baseline and Weeks 1 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
1401798|NCT01249404|Other Pre-specified|PGA of Treatment Response at Week 12|An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores at Week 12 are reported.|At Week 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 12 are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401799|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12|Muscle tone in the treated limb was assessed by MAS in the soleus (with the knee flexed) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.|Baseline and Weeks 1, 4 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401800|NCT01249404|Other Pre-specified|Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1 and 12 are reported.|Baseline and Weeks 1 and 12|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401801|NCT01249404|Secondary|Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed|Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.|Baseline and Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at baseline and Week 4 are included in the analysis.|||m/s||95% Confidence Interval|Least Squares Mean
1401802|NCT01249404|Secondary|Physician's Global Assesment (PGA) of Treatment Response at Week 4|An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.|At Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 4 are included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401803|NCT01249404|Primary|Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)|Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.|Baseline and Week 4|The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4.|||units on a scale||95% Confidence Interval|Least Squares Mean
1401804|NCT01249365|Primary|Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies|Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.|Throughout the study (from Month 0 to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
1401805|NCT01249365|Primary|Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)|"Medically significant conditions (MSCs) are defined as:~AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.~Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.~Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination."|Throughout the study (from Month 0 to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.|||Participants|||Count of Participants
1401806|NCT01249365|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.|Throughout the study (from Month 0 to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.|||Participants|||Count of Participants
1401809|NCT01249274|Secondary|Salivary Progesterone Concentrations|A comparison of salivary progesterone concentrations across all samples for all timepoints|week 2, week 6, week 10, week 12|intent-to-treat|||pg/ml of salivary progesterone||Standard Error|Mean
1401810|NCT01249274|Secondary|Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))|EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.|baseline to 12 weeks|intent-to-treat|||units on a scale||Standard Error|Mean
1401811|NCT01249274|Secondary|Cocaine Craving (Measured Weekly Using CCQ-Brief)|CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.|baseline to 12 weeks|intent-to-treat|||units on a scale||95% Confidence Interval|Mean
1401812|NCT01249274|Secondary|Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group|To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.|12 weeks postpartum|intent-to-treat|||adverse events|||Number
1401813|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|baseline, end of trial (week 12) and 3-month post-trial follow-up|intent-to-treat|||proportion of positive urines per week||95% Confidence Interval|Mean
1401814|NCT01249274|Primary|Proportion of Positive Urine Samples Per Week|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.|weekly measurements, baseline to 12 weeks|intent-to-treat|||proportion of positive urines per week||95% Confidence Interval|Mean
1401815|NCT01249274|Primary|Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar|baseline, end of trial (week 12), 3-month post-trial follow-up|intent-to-treat|||days of cocaine use between visits||95% Confidence Interval|Mean
1401816|NCT01249274|Primary|Mean Number of Days Per Week of Cocaine Use|Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.|Weekly measurements, Baseline to 12 weeks|intent-to-treat|||number of days per week of cocaine use||Standard Deviation|Mean
1401817|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Baseline, Year 1 compared with Endpoint (last measurement during the treatment period through Month 12), Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401818|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 12, ITT Population|Baseline, Year 1 compared with Month 12, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401819|NCT01249261|Primary|Mean Percent Change in Total Proximal Femur BMD From Core Study Baseline, Month 6, ITT Population|Baseline, Year 1 compared with Month 6, Year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401820|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (through Month 12, Year 8) compared with baseline Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401821|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 12, ITT Population|Baseline, year 1 compared with Month 12, year 8. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401822|NCT01249261|Primary|Mean Percent Change in Femoral Trochanter BMD From Core Study Baseline, Month 6, ITT Population|Month 6, Year 8 compared to Baseline, Year 1. Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401823|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the treatment period (thru Month 12, Year 8). Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401824|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 12, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1404214|NCT01227785|Primary|Clinical Performance at Implant LV Pacing Impedance for CRT-D.|LV pacing impedance results at implant were measured in CRT-D.|implant|78 CRT-D patients had data available at implant|||Ohms||Standard Deviation|Mean
1401825|NCT01249261|Primary|Mean Percent Change in Femoral Neck BMD From Core Study Baseline, Month 6, ITT Population|Allowed equipment Hologic or Lunar. Same equipment used in prior study should be used for all patient visits. Normalized baseline femoral neck BMD lunar equipment only 0.836*BMD - 0.008; Hologic reference. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401826|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12/Endpoint, ITT Population|Endpoint is the last measurement during the 12 month treatment period during Year 8. Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12/Endpoint (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401827|NCT01249261|Primary|Mean Percent Change in Lumbar Spine BMD From Core Study Baseline, Month 12, ITT Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 12 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401828|NCT01249261|Primary|Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Core Study Baseline, Month 6, Intention to Treat (ITT) Population|Hologic or Lunar Machines: same equipment used in prior study should be used for all patient visits. sBMD (standardized BMD): Lunar sBMD = 952.2*BMD, Hologic sBMD = 1075.5*BMD. All scans analyzed centrally by Synarc (Portland, OR).|Baseline Core Study (Year 1) to Month 6 (Year 8)|ITT Population|||Percent Change||Standard Error|Mean
1401829|NCT01249157|Primary|To Evaluate the Accuracy of Preoperative 18FDG PEM|using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.|2 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
1401830|NCT01249131|Primary|Apparent Volume of Distribution (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1401831|NCT01249131|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1401832|NCT01249131|Primary|Minimum Observed Plasma Concentration (Cmin)||Day 1 at 0 hour (predose)|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1401833|NCT01249131|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1401834|NCT01249131|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose|Pharmacokinetic parameters populations included all enrolled participants. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1401835|NCT01249118|Primary|Percent of GDC-0973 Excreted in the Urine (% Excreted) for IV and Oral GDC-0973|% Excreted is the mean percentage of dose recovery in urine and calculated as: (Aeu divided by dose) multiplied by 100, where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose|Full analysis population.|||Percent dose excreted||Geometric Coefficient of Variation|Geometric Mean
1401836|NCT01249118|Primary|Renal Clearance (CLR) of IV and Oral GDC-0973|CLR was calculated as Aeu divided by AUC (0 - ∞), where Aeu was amount of drug excreted in urine from time 0 to 96 hrs post-dose and AUC(0 - ∞) was area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity hrs post-dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1 for plasma; 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose for urine|Full analysis population.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1401837|NCT01249118|Primary|Amount of Drug Excreted in the Urine (Aeu) of IV and Oral GDC-0973|The cumulative amount of drug excreted in urine over the entire collection interval of 96 hrs was calculated by adding the Aeu of the intervals 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 hrs where Aeu was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|Part 2: 0 to 12, 12 to 24, 24 to 48, 48 to 72, and 72 to 96 Hrs post-dose on Day 1|Full analysis population.|||mg||Geometric Coefficient of Variation|Geometric Mean
1401854|NCT01249092|Secondary|Change in Serum Concentration of Tissue Inhibitor Metalloproteinase 1 (TIMP-1) After PTX Therapy.|Serum concentration of tissue inhibitor metalloproteinase 1 (TIMP-1), a fibrosis biomarker of interest, will be measured and the change in serum levels between entry and end of study will be calculated.|6 months|Serum samples from both timepoints (entry and end of study) were available in only 16 of the 18 subjects who completed the study.|||ng/mL||Standard Error|Mean
1401838|NCT01249118|Primary|Mean Absorption Time (MAT)|MAT is mean time required for the drug to reach the central compartment. MAT was estimated from the mean resident time (MRT) from oral and IV administration. MAT was calculated as MRT last of oral dose minus MRT last of IV dose. MAT is analyzed when drug is administered orally (only for non-IV routes of administration).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|"Full analysis population who received oral dose of GDC-0973. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||hr||Geometric Coefficient of Variation|Geometric Mean
1401839|NCT01249118|Primary|Absolute Oral Bioavailability (F) of GDC-0973|Absolute oral bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose. F = [AUC (0-∞), oral multiplied by Dose IV] divided by [AUC (0-∞), IV multiplied by Dose oral]. Absolute oral bioavailability is determined for drugs which are administered orally. IV dose is 100% in systemic circulation (dosed directly) and hence no estimation is required.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1401840|NCT01249118|Primary|Apparent Volume of Distribution (Vz/F) of Oral GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1401841|NCT01249118|Primary|Volume of Distribution at Steady State (Vss) of IV GDC-0973|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose of Day 1|Full analysis population who received IV dose of GDC-0973.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1401842|NCT01249118|Primary|Apparent Oral Clearance (CL/F) of Oral GDC-0973|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modelling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received oral dose of GDC-0973.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1401843|NCT01249118|Primary|Systemic Clearance (CL) of IV GDC-0973|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population who received IV dose of GDC-0973.|||Liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
1401844|NCT01249118|Primary|Plasma Decay Half-Life (t1/2) of IV and Oral GDC-0973|t1/2 is the time measured for the plasma concentration of GDC-0973 to decrease by one half.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||hr||Geometric Coefficient of Variation|Geometric Mean
1401845|NCT01249118|Primary|Dose Normalized AUC (0 - ∞) [AUC (0 - ∞)dn] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞)dn is AUC(0 - ∞) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1401846|NCT01249118|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of IV and Oral GDC-0973|AUC (0 - ∞)= Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1401847|NCT01249118|Primary|Dose Normalized AUC (0-t) [AUC (0-t)dn] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). AUC (0-t)dn is AUC (0-t) divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1401848|NCT01249118|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of IV and Oral GDC-0973|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1401849|NCT01249118|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||hr||Full Range|Median
1401850|NCT01249118|Primary|Minimum Observed Plasma Trough Concentration (Cmin) of IV and Oral GDC-0973||Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1401851|NCT01249118|Primary|Dose Normalized Cmax [Cmax(dn)] of IV and Oral GDC-0973|Cmax(dn) is Cmax divided by dose.|Part 2: 0 Hrs (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1401852|NCT01249118|Primary|Maximum Observed Plasma Concentration (Cmax) of IV and Oral GDC-0973||Part 2: 0 hours (Hrs) (pre-dose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 Hrs post-dose on Day 1|Full analysis population included participants who were randomized, received study drug, and had at least 1 valid PK parameter.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1401853|NCT01249092|Secondary|Safety of Therapy in the Pilot Study of PTX Therapy in Patients With PBC Will be Assessed|The number of participants that experienced any severe adverse events will be monitored and recorded.|6 months||||participants|||Number
1401856|NCT01248949|Primary|Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline|KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead.|From start of study drug administration up to 30 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617|||Participants|||Number
1401857|NCT01248949|Secondary|Circulating Levels of Angiopoietin 2 (Ang2)|Profile of Ang2 post MEDI3617 administration in relation to time course of antibody concentrations.|Prior to infusion on Cycle 4 and Cycle 5|All participants who received treatment with MEDI3617 and for whom PD blood samples were collected and evaluated.|||nanogram per millileter (ng/mL)||Standard Deviation|Mean
1401858|NCT01248949|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until death due to any cause|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
1401859|NCT01248949|Secondary|Progression-Free Survival (PFS)|PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
1401860|NCT01248949|Secondary|Time to Progression (TTP)|Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
1401861|NCT01248949|Secondary|Duration of Response (DOR)|Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
1401862|NCT01248949|Secondary|Time to Response (TTR)|Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be “0” if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||months||Full Range|Median
1401863|NCT01248949|Secondary|Objective Response Rate (ORR)|Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (the sum may not be “0” if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Time from the first dose of investigational product until end of study|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
1401864|NCT01248949|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.|Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617|All participants who received treatment with MEDI3617.|||participants|||Number
1401865|NCT01248949|Secondary|Terminal Elimination Half Life (t1/2) of MEDI3617|"The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||day||Standard Deviation|Mean
1401866|NCT01248949|Secondary|Systemic Clearance (CL) of MEDI3617|"Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||milliliter per day (mL/day)||Standard Deviation|Mean
1401867|NCT01248949|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617|"The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||day*mcg/mL||Standard Deviation|Mean
1401868|NCT01248949|Secondary|Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617|"AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||day*mcg/mL||Standard Deviation|Mean
1401869|NCT01248949|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI3617|"Cmax is the maximum observed serum concentration of MEDI3617. Here, n is number of participants analyzed for this endpoint at a specific dose."|Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose|All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
1401870|NCT01248949|Primary|Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617|||Participants|||Number
1401871|NCT01248949|Primary|Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
1401872|NCT01248949|Primary|Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)|Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
1401873|NCT01248949|Primary|Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)|Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
1401874|NCT01248949|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events occurring after administration of investigational product.|From start of study drug administration up to 90 days after the last dose of MEDI3617|Safety population included all participants who received treatment with MEDI3617.|||Participants|||Number
1401884|NCT01248884|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
1401920|NCT01248715|Primary|Number of Participants With Clinical Failure (Failure to Reach Clinical Stability)|Number of subject that showed lack of clinical improvement within 7 days. Criteria for clinical improvement include no fever; white blood cell count decreases, or increases in the case of leukopenia, to more than 10% from the prior day; the evaluation of signs and symptoms of CAP to define when the patient is subjectively better, and the patient is able to tolerate food by mouth.|7 days||||Participants|||Count of Participants
1401875|NCT01248949|Primary|Maximum Tolerated Dose (MTD)|The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.|From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)|DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.|||milligram (mg)|||Number
1401876|NCT01248949|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.|From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)|DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.|||Participants|||Number
1401877|NCT01248936|Primary|Number of Participants With Any Serious Adverse Event, Death and Cause of Death|Serious Adverse Event (SAEs) is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Number of participants who died and the cause of death are also recorded.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.|||participants|||Number
1401878|NCT01248936|Primary|Number of Participants With Any Adverse Event, Adverse Events With Severity, Adverse Events Leading to Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded according to the ‘National Cancer Institute Common Terminology Criteria for Adverse Events’ (NCI CTCAE, v4.0). However Laboratory data will be summarized by grade using the NCI CTCAE, v4.0 toxicity grade.|Up to 1 year|The safety population was defined as participants who received at least one dose, or a partial dose, of vemurafenib.|||participants|||Number
1401879|NCT01248936|Secondary|Mean Time to Complete Response/Partial Response|Mean time to Complete Response (CR)/Partial Response(PR) (confirmed or unconfirmed was assessed). Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Months||Standard Deviation|Mean
1401880|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was confirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants were assessed for best overall response by investigator as per RECIST v1.1. The ‘n’ is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Participants|||Number
1401881|NCT01248936|Secondary|Number of Participants With Best Overall Response (Confirmed)|The best overall response (confirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was confirmed. Participants were assessed for best overall response by investigator as per RECIST v1.1.|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Participants|||Number
1401882|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed) by ECOG Performance|The best overall response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed in patients with Eastern Cooperative Oncology Group (ECOG) performance status 2 or 3/0 or 1. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. This endpoint was tumor response category according to investigator assessment per RECIST v1.1 for efficacy assessment. The ‘n’ is number of participants with ECOG performance status in each criteria.|Up to 1 year|The efficacy population was defined as treated patients who had measurable disease at baseline and at least one post-baseline tumor assessment.|||Participants|||Number
1401883|NCT01248936|Secondary|Number of Participants With Best Overall Response (Unconfirmed)|The best overall response (unconfirmed) is the best response recorded from the start of the treatment until disease progression/recurrence which was unconfirmed. Participants were assessed for best overall response by investigator as per 'Response Evaluation Criteria in Solid Tumors' (RECIST v1.1).|Up to 1 year|The efficacy population was defined as treated participants who had measurable disease at baseline and at least one post-baseline tumor assessment.|||participants|||Number
1401885|NCT01248884|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
1401886|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
1401887|NCT01248884|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Participants|||Count of Participants
1401888|NCT01248884|Secondary|Number of Subjects With a Vaccine Response to PT and PRN.|Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
1401889|NCT01248884|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||µg /mL||95% Confidence Interval|Geometric Mean
1401890|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
1401891|NCT01248884|Secondary|Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1401892|NCT01248884|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
1401893|NCT01248884|Secondary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Months 0 and 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1401894|NCT01248884|Primary|Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1401906|NCT01248780|Secondary|American College of Rheumatology 20 Response, Using CRP, at Week 24|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Number of participants|||Number
1401967|NCT01247571|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|Time from start of treatment to time of death or the date of last contact, assessed up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1401895|NCT01248884|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
1401896|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
1401897|NCT01248884|Primary|Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1401898|NCT01248884|Primary|Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1401899|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
1401900|NCT01248884|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 0|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.|||Participants|||Count of Participants
1401901|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14|BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Score on a scale||Standard Deviation|Mean
1401902|NCT01248793|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14|BASFI is a participant’s self-assessment, represented as a mean (Visual Analogue Scale [Score]; 0 cm [easy] to 10 cm [impossible]) of 10 questions, 8 of which relate to the participant’s functional anatomy and 2 of which relate to a participant’s ability to cope with everyday life. A negative change from baseline indicates improvement.|Baseline and Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Score on a scale||Standard Deviation|Mean
1401903|NCT01248793|Secondary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 24|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Participants|||Number
1401904|NCT01248793|Primary|Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14|Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation|Week 14|Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment|||Participants|||Number
1401905|NCT01248780|Secondary|HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline|The HAQ assesses the degree of difficulty a person has in accomplishing tasks in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). The full range of the HAQ scale is 0-24 with 0 being the best possible outcome. The HAQ score is calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3 with 0 being the best possible outcome (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, or 3=unable to do). The mean change from baseline at Week 24 in HAQ score is provided below for each treatment group. A negative change from baseline is indicative of a lesser degree of difficulty in accomplishing tasks assessed in the HAQ.|Baseline to Week 24|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Scores on a scale||Standard Deviation|Mean
1401907|NCT01248780|Secondary|Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein)|"DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient’s assessments of disease activity. A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A DAS28 (using CRP) responder is defined as a participant with a DAS28 response of “Good” or “Moderate” at Week 14. A Good response is defined as a patient with a DAS28 score of <= 3.2 at Week 14 with improvement from Baseline in DAS28 score of > 1.2. A “Moderate” response was defined as a patient with DAS28 score of >3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of >0.6 to >1.2 The table below shows the number of participants in each treatment group who were DAS28 responders at Week 14."|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Number of participants|||Number
1401908|NCT01248780|Primary|American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14|ACR 20 response is defined as >= 20% improvement in rheumatoid arthritis (RA) symptoms and disease activity.|Week 14|Participants randomized (ie, intent-to-treat population) according to their assigned treatment group regardless of whether or not they received the assigned treatment.|||Number of participants|||Number
1401909|NCT01248728|Secondary|Change From Baseline in the Preschool Language Scale (PLS-4) - Total Language|"The PLS-4 is a language measure that provides a global assessment of a child's language functioning abilities, receptive and expressive language.~Secondary outcome measure domain: Total language standard score~Total Language Standard Score Range:~Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities)~The total language standard score is computed from a sum of the auditory comprehension and expressive communication standard scores, then converted into the total language standard score.~Change of total language standard scores from baseline to week 24 is reported. Positive change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
1401910|NCT01248728|Secondary|Change From Baseline in the Vineland Adaptive Behavioral Scales (VABS) - Adaptive Functioning Composite|"The VABS is a measure of adaptive behavior in daily settings. Secondary measure domain: The adaptive functioning composite describes an individuals overall functioning~Adaptive Behaviour Composite Standard Score Range:~Minimum range: 20 (low adaptive functioning) Maximum range: 160 (high adaptive functioning)~The adaptive behaviour composite standard score is computed from the sum of standard scores from the communication, daily living skills, socialization and motor skills domains and converted into the adaptive behavior composite standard score.~Change in the adaptive behaviour composite standard score from baseline to week 24 is reported. Positive change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
1401911|NCT01248728|Secondary|Number of Participants Classified as Responders by the Clinical Global Impression - Improvement (CGI-I)|"The CGI-I is a seven-point scale that provides a clinician rating of global improvement and as such is already inherently a measure of change. It requires the clinician to assess the degree to which the participant's illness has improved or worsened relative to a baseline state before the intervention.~Change is rated as:~0- Not assessed~Very Much Improved~Much Improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse~Participants are classified as responders if their CGI-I score was 1 or 2 and non-responders for CGI-I scores of 3 to 7."|24 weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||participants classified as responders|||Number
1401912|NCT01248728|Primary|Change From Baseline in the Behaviour Assessment System for Children (BASC-2) - Externalizing Problems Composite|"The BASC-2 externalizing problems composite measures hyperactivity and aggressive behaviours.~Primary Outcome domain: Externalizing Problems composite~Externalizing Problems Composite T-Score Range:~Minimum Range: 10 (lower externalizing problems) Maximum Range: 120 (higher externalizing problems)~The Externalizing Problems composite is computed from the sum of t-scores from the hyperactivity and aggression subscales then converted into the externalizing problems composite t-score.~Mean change between baseline and week 24 is reported. A negative change indicates improvement."|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
1401913|NCT01248728|Primary|Change From Baseline in the Pervasive Developmental Disorder-Behavioral Inventory (PDDBI) - Autism Composite Score|"The PDDBI measures autism symptomology. The autism composite score was used as the primary outcome measure for autism symptom severity.~PDDBI Autism Composite Scale Range:~Minimum Range = 10 (lower autism symptom severity) Maximum Range = 100 (higher autism symptom severity)~The Autism Composite is calculated from the sum of T-scores of the Sensory/Perceptual Approach Behaviours, Ritualisms/Resistance to Change, Social Pragmatic Problems, and Semantic/Pragmatic Problems domains subtracted by the sum of T-scores of the Social Approach Behaviours, and Expressive Language domain then converted into the Autism Composite as a T-score.~Mean change between baseline and week 24 is reported. A negative change indicates improvement"|Baseline and 24 Weeks|1 participant was dropped from the analysis in the Omega-3 group as there was insufficient data due to early termination.|||units on a scale||95% Confidence Interval|Mean
1401914|NCT01248715|Secondary|Number of Participants With Hospital Mortality.|Number of subjects who died while hospitalized|through study completion, up to 30 days||||Participants|||Count of Participants
1401915|NCT01248715|Secondary|Length of Hospital Stay|Duration of hospitalization calculated as the day of discharge minus the day of admission.|through study completion, up to 30 days||||days||Inter-Quartile Range|Median
1401916|NCT01248715|Secondary|Days to Reach Clinical Stability|Time to clinical improvement. The criteria for clinical improvement were followed during the first week from the day of admission and defined as follows: a) improvement of signs and symptoms of LRTI reported by patient b) afebrile for at least 8 hours, c) decrease in white blood cell count to more than 10% from the prior day, and d) able to tolerate oral feeding. A patient was considered clinically improved on the day that these four criteria were all met.|30 days||||days||Inter-Quartile Range|Median
1401917|NCT01248715|Primary|Number of Participants That Had Short-term Mortality|Number of subjects who died within 30 days of enrollment|30 days||||Participants|||Count of Participants
1401921|NCT01248468|Secondary|Percent of Subjects Who Are Free of Photophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours||||Percent of participants|||Number
1401922|NCT01248468|Secondary|Percent of Subjects Who Are Free of Phonophobia at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.|||Percent of participants|||Number
1401923|NCT01248468|Secondary|Percent of Subjects Who Are Free of Nausea at 2 Hours.|Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.|||percent of participants|||Number
1401924|NCT01248468|Primary|Percent of Subjects Who Are Pain Free at 2 Hours.|Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours|2 hours|The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.|||Percent of participants|||Number
1401925|NCT01248455|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|3 years, 5 months||||Participants|||Count of Participants
1401926|NCT01248455|Primary|Response Rate|Response rate is defined as the percentage of participants with a 50% decline in monoclonal protein (M-protein) assessed by the International Multiple Myeloma Working Group (IMWG) for multiple myeloma (MM) criteria. Minimal response (MR) is MR >25% and <50% decrease in M-protein. Biochemical progression (BP) is asymptomatic, ≥ 25% M-protein increase from baseline and an absolute increase of M-protein of 0.75 g/dL demonstrated on two separate occasions. Progressive disease (PD), (clinical progression to symptomatic MM) is development of CRAB (hyperCalcemia (corrected calcium >2.75 mmol/L), Renal insufficiency (attributed to MM), Anemia (hemoglobin <10g/dL), and Bone lesions (lytic lesions or osteoporosis with compression fractures) criteria end organ damage. Stable disease (SD) is not meeting the criteria for minimal response, biochemical progression and progressive disease.|1 year|Study stopped after the first stage due to the lack of patients meeting the defined primary objective (50% decline in M-protein).|||percentage of participants|||Number
1401927|NCT01248416|Secondary|Change in Estrone||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 1 Subject, did not have Estrone results available for the 24 month visit (N=64).|||pg/mL||Standard Error|Mean
1401928|NCT01248416|Secondary|Change in Estradiol|Those taking AI alone or AI/GH combined were grouped by type, either anastrozole or letrozole.|0 to 24 months|Of the 51 AI alone or AI/GH combined Subjects, 41 completed all procedures at 24 months, however, 1 Subject did not have Estrone results available for the 24 month visit (N=40).|||pg/mL||Standard Error|Mean
1401929|NCT01248416|Secondary|Change in Testosterone||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months.|||ng/dL||Standard Error|Mean
1401930|NCT01248416|Secondary|Change in IGF-I Concentrations||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 1 Subject, did not have IGF-1 results available for the 24 month visit (N=64).|||ng/mL||Standard Error|Mean
1401931|NCT01248416|Secondary|Change in Body Mass Index||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months.|||kg/m^2||Standard Error|Mean
1401932|NCT01248416|Secondary|Change in Lean Body Mass||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 2 Subjects had a screw/pin in their leg/hip at the 24 month visit, and therefore, could not have a DEXA scan performed (N=63).|||kg||Standard Error|Mean
1401933|NCT01248416|Secondary|Change in Bone Density z Score Adjusted for Height||0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months, however, 2 Subjects had a screw/pin in their leg/hip at the 24 month visit, and therefore, could not have a DEXA scan performed (N=63).|||z-score||Standard Error|Least Squares Mean
1401934|NCT01248416|Primary|Change in Predicted Height|Primary efficacy end point: change in predicted height (cm) from baseline at 24 months based on change in bone age (years)|0 to 24 months|Of the 76 Subjects, 65 completed all procedures at 24 months.|||centimeters||Standard Error|Least Squares Mean
1401935|NCT01248416|Primary|Change in Height|Differences in height gains|0 to 24 months|Differences in height gains from 0 to 24 months; Of the 76 Subjects, 65 completed all procedures at 24 months.|||Centimeters||Standard Error|Mean
1401936|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||g||Standard Error|Least Squares Mean
1401968|NCT01247571|Secondary|Progression-free Survival|Progression-free survival is the period from study entry until disease progression, death or date of last contact|From start of treatment to time of progression or death, assessed up to 5 years|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1401937|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1|Treated set (OR)|||g||Standard Error|Least Squares Mean
1401938|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28|"Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||g||Standard Error|Least Squares Mean
1401939|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28|"Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||g/dL/h||Standard Error|Least Squares Mean
1401940|NCT01248364|Primary|Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1|Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)|||g/dL/h||Standard Error|Least Squares Mean
1401941|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1|Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.|0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1|Treated set (OR)|||g||Standard Error|Least Squares Mean
1401942|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28|"Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable."|Baseline and day 28|Treated set (OR) for patients who completed the day 28 visit|||umol/kgFFM/min||Standard Error|Least Squares Mean
1401943|NCT01248364|Secondary|Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1|Change from baseline in rate of endogenous glucose production (EGP) fast after one dose|Baseline and day 1|Treated set (OR)|||umol/kgFFM/min||Standard Error|Least Squares Mean
1401944|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 28|"Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28.~Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable"|Baseline and day 28|Treated set, which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)), for patients who completed the day 28 visit|||mmol/L||Standard Error|Least Squares Mean
1401945|NCT01248364|Primary|Change From Baseline in Fasting Plasma Glucose at Day 1|Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1|Baseline and day 1|Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR))|||mmol/L||Standard Error|Least Squares Mean
1401946|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|A multiple linear regression model approach was used to estimate gastric emptying based on the breath test samples at each time point. Gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal||||proportion of tracer||Standard Deviation|Mean
1401947|NCT01248221|Secondary|Gastric Emptying at 60, 120, and 240 Minutes Measured by Scintigraphy|The scintigraphic gastric emptying (GE) metric is the proportion of tracer emptied from the stomach at time, t.|60, 120, and 240 minutes after ingestion of standard meal||||proportion of tracer||Standard Deviation|Mean
1401948|NCT01248221|Primary|Gastric Emptying Half Time Measured by 13C Spirulina Gastric Emptying Breath Test (GEBT)|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.|4 hours after ingestion of standard meal||||minutes||Standard Deviation|Mean
1401949|NCT01248221|Primary|Gastric Emptying Half Time Measured by Scintigraphy|Gastric emptying half time is the time for half of the ingested solids to leave the stomach. This value was measured by standard 99m Tc scintigraphy.|4 hours after ingestion of standard meal||||minutes||Standard Deviation|Mean
1401950|NCT01248130|Primary|Change in NIMH Clinical Global Impression Scale for Pervasive Developmental Disorders (CGI-PDD) Improvement Scores|The CGI-PDD is a well-established, 3-item, clinician-rated measure of global symptom severity and treatment response, specifically for PDD. This scale allows the clinician to rate the severity of the participant’s PDD relative to baseline.|weekly|||||||
1401951|NCT01248130|Primary|Change in Social Responsiveness Scale (SRS) Total Raw Score|Change in SRS Total Raw Score|pre-treatment, 6 weeks, post-treatment (12 weeks)|||||||
1401952|NCT01248065|Secondary|Exacerbations|Outcome defined as number of exacerbations per person-year.|Overall exacerbation rate during 28-week trial||||Exacerbations/person-year||95% Confidence Interval|Number
1401953|NCT01248065|Secondary|Lung Function Change From Baseline|FEV1 (liters) and methacholine PC20 will be evaluated. Changes are measured as 28 weeks minus baseline.|Change is measured as value at 28 weeks minus baseline value.||||Liters||95% Confidence Interval|Least Squares Mean
1401969|NCT01247571|Primary|Number of Patients With Grade 3 or Higher Adverse Events|Grade 3 or higher adverse events were graded by CTCAE v4.|Every cycle while on treatment|Eligible and Treated Patients|||participants|||Number
1401954|NCT01248065|Primary|Treatment Failure|Treatment failure is a well-defined asthma outcome reflecting overall asthma control that has been used previously in multiple clinical trials. Treatment failure as defined in the current proposal and prior trials is consistent with the American Thoracic Society (ATS)/European Respiratory Society(ERS) definition of a moderate exacerbation - a deterioration in symptoms and/or lung function with increased rescue bronchodilator use that lasts 2 days or more. The percentages of participants experiencing a treatment failure are Kaplan-Meier estimates of failure rate.|Twenty-eight week intervention period from randomization until end of trial.||||Percentage of participants||95% Confidence Interval|Number
1401955|NCT01248013|Primary|Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy.|The IBS Symptom Severity Scale has four components, severity of abdominal pain, number of days with pain in past 10 days, abdominal distension, bowel habit and interference with life in general. Maximum score is 500, minimum score is 0. The lower the score, the lower the symptom severity. Participants are considered clinically improved if they have a reduction in score of 50 points or greater.|One year after termination of treatment||||percentage of participants|||Number
1401956|NCT01248013|Secondary|Outcome Predictors|to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result|one year|||||||
1401957|NCT01248013|Primary|Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome|assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months|one year|||||||
1401958|NCT01247974|Primary|Primary Effectiveness Endpoint|Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.|7 days postoperatively or hospital discharge, whichever is sooner|Primary analysis was based upon the ITT population using multiple imputation to impute missing values. The ITT population was defined as all subjects who provided informed consent and were randomized in the trial.|||percentage of participants|||Number
1401959|NCT01247974|Primary|Primary Safety Endpoint|"A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure:~Death~Myocardial Infarction (MI)~Stroke~Mediastinal Reoperation~Percutaneous Coronary Intervention (PCI)"|30 days postprocedure|Performed with the FAS population using multiple imputation methods to impute values for missing or incomplete data. FAS population was defined as subjects in the ITT population who had CABG surgery and received their assigned treatment.|||percentage of participants|||Number
1401960|NCT01247922|Secondary|Median Treatment Duration||From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)|SAF|||days||Full Range|Median
1401961|NCT01247922|Secondary|Best Overall Response|Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing.|End of treatment (The mean treatment duration was 170.5 days.)|SAF|||participants|||Number
1401962|NCT01247922|Primary|Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)|Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.|From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)|The analysis population is the Safety Analysis Set (SAF) consisted of all enrolled patients who received at least 1 dose of study drug.|||participants|||Number
1401963|NCT01247675|Secondary|Emax of IGF-I|"As part of the following endpoint:~Pharmacodynamic (PD) response of serum Insulin-like Growth Factor-I (IGF-I) from ACP-001 treated dose groups compared to the PD response of IGF-I from the daily Omnitrope treated group.~Emax (maximum observed response) values at Week 4"|Days 22 to 29|Pharmacokinetic and pharmacodynamic analysis was performed on all patients who had at least one measurement of the primary variable and who had attended the Day 28 study visit. Two patients in Cohort 2 (ACP-001, 0.04 mg hGH/kg/wk) were withdrawn from the study before Day 28 and were therefore excluded from the analysis.|||ng/mL||Standard Deviation|Mean
1401964|NCT01247675|Secondary|Cmax of hGH|"As part of the following endpoint:~Pharmacokinetic (PK) profile of serum human Growth Hormone (hGH) from ACP-001 treated dose groups compared to the PK profile of hGH from the daily Omnitrope treated group.~Cmax (maximum value of concentration) values at Week 4"|Days 22 to 29|Pharmacokinetic and pharmacodynamic analysis was performed on all patients who had at least one measurement of the primary variable and who had attended the Day 28 study visit. Two patients in Cohort 2 (ACP-001, 0.04 mg hGH/kg/wk) were withdrawn from the study before Day 28 and were therefore excluded from the analysis.|||ng/mL||Standard Deviation|Mean
1401965|NCT01247675|Primary|Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation|Number of subjects with treatment emergent anti-hGH binding antibodies|Start of study treatment through Day 42|All patients who were randomized and received at least one dose of test product were included in the Safety analysis.|||Participants|||Number
1401966|NCT01247675|Primary|Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)|Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.|Start of study treatment through Week 4|All patients who were randomized and received at least one dose of test product were included in the Safety analysis.|||Number of subjects with any symptom|||Number
1401970|NCT01247571|Primary|Percentage of Participants With Progression-free Survival (PFS) at 6 Months|Progression-free survival is the period from study entry until disease progression, death or date of last contact. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20 % increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1401971|NCT01247571|Primary|Objective Tumor Response (Complete or Partial)|Complete and Partial Tumor Response by RECIST 1.0. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|CT scan or MRI if used to follow lesion(s) for measurable disease every other cycle for the first 6 mnths; then every 3 mnths thereafter until dx progression is confirmed; also repeat any other time clinically indicated, assessed up to 6 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1401972|NCT01247428|Secondary|OCT Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|18 M|27 out of 30 patients analyzed|||percentage of struts uncovered||Full Range|Median
1401973|NCT01247428|Secondary|Optical Coherence Tomography (OCT) Evaluation: % Stent Strut Uncovered|% stent strut uncovered is defined as the ratio of uncovered struts to total struts in all cross-sections.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 9/30 patients had evaluable OCT at the 8 month timeframe.|||percentage of struts uncovered||Full Range|Median
1401974|NCT01247428|Secondary|IVUS Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|18 months|20 out of 30 participants analyzed|||percentage of volume obstruction||Standard Deviation|Mean
1401975|NCT01247428|Secondary|Intravascular Ultrasound (IVUS) Evaluation: % Neointimal Volume Obstruction|% neointimal volume obstruction is defined as the neointimal volume divided by stent volume.|8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months. Only 25/30 patients had evaluable IVUS data.|||percentage of volume obstruction||Standard Deviation|Mean
1401976|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|18 months|Population includes participants from whom data was collected.|||participants|||Number
1401977|NCT01247428|Secondary|Angiographic Evaluation: In-stent Binary Restenosis|Binary Restenosis is defined as ≥50% luminal narrowing at follow-up angiography.|4 months, 6 months, 8 months|Patients evaluated at 4(n=10), 6(n=10) and 8(n=10) months.|||participants|||Number
1401978|NCT01247428|Secondary|Stent Thrombosis|The presence of an intracoronary thrombus that originates in the stent or in the segments 5 mm proximal or distal to the stent post-procedure|240 days||||percentage of participants||95% Confidence Interval|Number
1401979|NCT01247428|Secondary|Target Lesion Failure (TLF)|"Target lesion failure (TLF) is defined as the composite endpoint of:~cardiac death,~target-lesion myocardial infarction (Q wave or non-Q wave), and~clinically indicated target lesion revascularization"|240 days||||percentage of participants||95% Confidence Interval|Number
1401980|NCT01247428|Secondary|Target Vessel Failure (TVF)|"Target vessel failure (TVF) is defined as the composite endpoint of:~cardiac death,~target-vessel myocardial infarction (Q wave or non-Q wave), and~clinically indicated target vessel revascularization"|240 days||||percentage of participants||95% Confidence Interval|Number
1401981|NCT01247428|Secondary|Clinically-driven Target Vessel Revascularization (TVR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:~A positive history of recurrent angina pectoris, presumably related to the target vessel;~Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;~Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);~A target vessel revascularization (TVR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days||||percentage of participants||95% Confidence Interval|Number
1401982|NCT01247428|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rates|"A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 50% (Angiographic Core Laboratory QCA assessment) and if one of the following occurs:~A positive history of recurrent angina pectoris, presumably related to the target vessel;~Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;~Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve);~A target lesion revascularization (TLR) with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms."|240 days||||percentage of participants||95% Confidence Interval|Number
1401983|NCT01247428|Secondary|Total Myocardial Infarction (MI)|"Q-wave MI (QWMI): requires one of the following criteria: the development of new abnormal Q waves in ≥2 contiguous ECG leads not present on the patient's baseline (i.e., before intervention) in association with a >2x upper limit normal elevation of creatine kinase (CK) levels. In the absence of ECG data, the clinical events committee may adjudicate a Q-wave MI based on the clinical scenario and appropriate cardiac enzyme data; chest pain or other acute symptoms consistent with myocardial ischemia and new pathological Q waves in ≥2 contiguous ECG leads in the absence of timely cardiac enzyme data.~Non-Q-wave MI (NQWMI): the elevation of CK levels (≥2 times ULN) with elevated CK-MB enzyme levels in the absence of new pathologic Q waves."|240 days||||percentage of participants||95% Confidence Interval|Number
1401984|NCT01247428|Secondary|Total Mortality|Total mortality (cardiac and non-cardiac)|240 days||||percentage of participants||95% Confidence Interval|Number
1401985|NCT01247428|Secondary|Procedural Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using the assigned device (including any adjunctive devices) without cardiac death, Myocardial infarction (MI) or repeat revascularization of the target lesion pre-hospital discharge|8 hours||||percentage of participants||95% Confidence Interval|Number
1401986|NCT01247428|Secondary|Lesion Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA) using any percutaneous method|8 hours||||percentage of participants||95% Confidence Interval|Number
1401989|NCT01247428|Primary|Angiographic In-Stent Late Lumen Loss|In-stent late lumen loss as measured by the angiographic core laboratory as the difference between the post-procedure minimal lumen diameters (MLD) in the treated segment (stented region) minus the MLD in the same region at follow-up.|8 months|Last observation used, such that patients (n=10) in the 8 month analysis is reported.|||mm||Standard Deviation|Mean
1401990|NCT01247350|Secondary|Pharmacokinetics: Renal Excretion of LY3009104|Percentage of LY3009104 excreted in urine from zero to 24 hours.|Day 1: continuous for 24 hours|Participants who were administered study drug (10 mg and 14 mg LY3009104 per protocol) and had pharmacokinetics (PK) samples for the analyses.|||percentage of drug||Geometric Coefficient of Variation|Geometric Mean
1401991|NCT01247350|Secondary|Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)|Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||hour (h)||Full Range|Median
1401992|NCT01247350|Secondary|Pharmacokinetics: Apparent Total Body Clearance of LY3009104|Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1401993|NCT01247350|Secondary|Pharmacokinetics: Apparent Volume of Distribution of LY3009104|Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
1401994|NCT01247350|Secondary|Pharmacokinetics: Half-Life(t1/2) of LY3009104|Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||hour (h)||Full Range|Geometric Mean
1401995|NCT01247350|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104|AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||nanomoles*hour/Liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1401996|NCT01247350|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104|Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.|Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose|Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.|||nanomoles/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1401997|NCT01247350|Primary|Number of Participants With Clinically Significant Effects|Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.|Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses|Participants who were administered study drug.|||Participants|||Count of Participants
1401998|NCT01247324|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab|Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.|Baseline up to week 96|Baseline evaluable participants with an ADA assay result from a baseline sample(s). The safety population included all participants who received any study drug. Here, n signifies the number of participants evaluable at the specified time points.|||Participants|||Number
1401999|NCT01247324|Secondary|Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)|AUC represents total drug exposure for one dosing interval after the 4th dose.|Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96|The pharmacokinetics (PK) population included all participants in the ocrelizumab group who had at least 1 measurable concentration value.|||micrograms per milliliter*day||Standard Deviation|Mean
1402000|NCT01247324|Secondary|Number of Participants With Adverse Events (AEs)|AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.|Baseline up to Week 96|The safety population included all participants who received any study drug.|||Participants|||Number
1402001|NCT01247324|Secondary|Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96|NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1402039|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Mean
1402002|NCT01247324|Secondary|Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Baseline, Week 96|Descriptive statistics at baseline include participants with assessment at baseline and at least one post- baseline value. ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||t-score||Standard Error|Mean
1402003|NCT01247324|Secondary|Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96|"Brain volume was recorded as an absolute normalized value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week."|From Week 24 up to Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percent change||Standard Error|Mean
1402004|NCT01247324|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96|MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.|Baseline, Week 96|ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||Z-score||Standard Error|Mean
1402005|NCT01247324|Secondary|Number of T1 Hypointense Lesions During the Double-Blind Treatment|The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.|||lesions|||Number
1402006|NCT01247324|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 108|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
1402007|NCT01247324|Secondary|Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks|Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1402008|NCT01247324|Secondary|Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment|The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.|||lesions|||Number
1402009|NCT01247324|Secondary|Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment|The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to Week 96|ITT population included all randomized participants in the study.|||lesions|||Number
1402037|NCT01247064|Primary|Respiratory Assessment Change Score (RACS)|The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.|Baseline and 1 hour||||units on a scale||95% Confidence Interval|Mean
1402010|NCT01247324|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 108|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
1402011|NCT01247324|Primary|Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks|ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.|Week 96|Intent-to-treat (ITT) population included all randomized participants in the study.|||relapses/participant year of treatment||95% Confidence Interval|Number
1402012|NCT01247298|Secondary|Percentage of Participants With Local Failure Patterns|Assess local failure patterns of patients treated with TACE & SBRT. This is assessed by the percentage of patients where recurrence occurred|Baseline up to 2 years after treatment completed||||percentage of participants|||Number
1402013|NCT01247298|Secondary|Percentage of Participants With Overall Survival|Assess overall survival (OS) of patients treated with TACE & SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.|up to 2 years after treatment completed|Survival analysis was performed for all patients.|||percentage of participants|||Number
1402014|NCT01247298|Primary|Local Recurrence Rate|Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.|Baseline to up to 2 years after treatment completed||||participants|||Number
1402015|NCT01247298|Primary|Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.|Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.|Baseline to up to 2 years after treatment completed||||months||95% Confidence Interval|Median
1402016|NCT01247298|Primary|Safety of a Combination Therapy|Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.|Baseline to 45 day after completing combination treatment.|All enrolled patients were analyzed.|||participants|||Number
1402017|NCT01247285|Secondary|AUC0-inf of Norfluoxetine.|Informational comparison of AUC0-inf values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402018|NCT01247285|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402019|NCT01247285|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1402020|NCT01247285|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402021|NCT01247285|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402022|NCT01247285|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1402023|NCT01247272|Secondary|AUC0-inf of Norfluoxetine.|Bioequivalence based on Norfluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402024|NCT01247272|Secondary|AUC0-t of Norfluoxetine.|Informational comparison of AUC0-t values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402025|NCT01247272|Secondary|Cmax of Norfluoxetine.|Informational comparison of Cmax values for the metabolite Norfluoxetine.|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1402026|NCT01247272|Primary|AUC0-inf of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402027|NCT01247272|Primary|AUC0-t of Fluoxetine.|Bioequivalence based on Fluoxetine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1402028|NCT01247272|Primary|Cmax of Fluoxetine.|Bioequivalence based on Fluoxetine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 25 day period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1402040|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 2|After the second dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Mean
1402041|NCT01246999|Secondary|Mean Peak Influenza B Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Log Mean
1402042|NCT01246999|Secondary|Mean Peak H3N2 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Log Mean
1402043|NCT01246999|Secondary|Mean Peak H1N1 Virus Titer, Dose 1|After the first dose of vaccine, the virus titer from nasal secretions was measured in tissue culture on days 2, 4 and 7 and the highest titer from one of those three time points was reported.|days 2, 4 and 7||||log10 TCID(50)/ml||Standard Deviation|Log Mean
1402044|NCT01246999|Primary|Number of Subjects Shedding Vaccine Virus of Each Subtype by PCR|Nasal washes were collected on days 2, 4 and 7 after vaccination. Nasal swab specimens were tested for the presence of vaccine viruses by quantitative viral culture in MDCK cells at 33º C and by real-time quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) amplification. The limit of detection of vaccine viruses was 10^0.6 tissue culture infectious doses (50%)/ml for virus culture and 10^0.4 tissue culture infectious doses (50%)/ml for qRT-PCR.|baseline to day 7|Outcome for shedding of live vaccine in all participants who received a live vaccine|||participants|||Number
1402045|NCT01246973|Secondary|Percentage of Subjects With Moist Desquamation|Moist desquamation was measured by the presence of wet, patchy crusting, oozing, or ulcerated skin in areas where skin was peeling in sheets.|6 weeks||||percentage of participants|||Number
1402046|NCT01246973|Primary|Mean Radiation Dermatitis Severity Score|The outcome measures will be the severity of radiation dermatitis, using the Radiation Dermatitis Score (RDS), at the end of treatment in each treatment arm. (Objective: To examine the efficacy of curcumin in preventing and/or reducing the severity of dermatitis in radiation treatment site in breast cancer patients). The RDS score ranges from 0-4 with higher scores indicating worse outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
1402047|NCT01246960|Other Pre-specified|Number of Participants With Adverse Events (AEs)|Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion (up to Month 28.3)|Safety population: randomized participants who received any quantity of study drug (Ramucirumab, mFOLFOX6, or placebo).|||participants|||Number
1402048|NCT01246960|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Months 1, 2, 4, 6, and 8|Randomized participants who received any quantity of ramucirumab or placebo, and were evaluated for the presence of anti-ramucirumab antibodies.|||participants|||Number
1402049|NCT01246960|Secondary|Time to Disease Progression (TTP)|TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD.|Randomization to measured PD (up to Month 25.0)|ITT population: all randomized participants. Thirty-five participants in the Ramucirumab and mFOLFOX6 treatment arm and 31 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||Full Range|Median
1402050|NCT01246960|Secondary|Duration of Response|Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time of first response to measured PD (up to Month 23.0)|Randomized participants who achieved an objective response of CR or PR. Eight participants in the Ramucirumab and mFOLFOX6 treatment arm and 8 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||95% Confidence Interval|Median
1402051|NCT01246960|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to <10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)*100.|Randomization to measured PD (up to Month 23.0)|ITT population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1402052|NCT01246960|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up.|Randomization to date of death from any cause (up to Month 28.3)|ITT population: all randomized participants. Twenty-seven participants in the Ramucirumab and mFOLFOX6 treatment arm and 32 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||95% Confidence Interval|Median
1402096|NCT01246206|Secondary|Overall Survival at Two Year,||Followed for up to two years post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1402053|NCT01246960|Primary|Progression-Free Survival (PFS)|PFS was defined using Response Evaluation Criteria in Solid Tumors [RECIST version (v.) 1.1] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date.|Randomization to measured PD or date of death from any cause (up to Month 25.0)|ITT population: all randomized participants. Fourteen participants in the Ramucirumab and mFOLFOX6 treatment arm and 15 participants in the Placebo and mFOLFOX6 treatment arm were censored.|||months||95% Confidence Interval|Median
1402054|NCT01246895|Other Pre-specified|Percentage Change in Quality of Life Assessed Using the SF-36 Questionnaire.|SF-36 v2 includes 2 aggregate measures—Physical and Mental components—derived from 8 subscales. Least squares means are adjusted for baseline. Higher positive scores indicate better results. Scoring ranges from 0 to 100%.|1 and 5 years||||Percent change from baseline||Standard Deviation|Least Squares Mean
1402055|NCT01246895|Secondary|The Number of Participants With Adverse Events Until 5 Years|Safety was assessed by recording the number of participants with Adverse Events (AEs) and their severity from the time of ICF signing up to 5 years post-treatment.|5 years|Participants who experienced adverse events|||participants|||Number
1402056|NCT01246895|Secondary|Percentage Change From Baseline for Knee-related Pain, Stiffness and Function at 5 Years (WOMAC Parts A, B, C)|The three sub-scales: 1) Pain, 2.) stiffness and 3.) function scores ranged from 0-10. Pain had 5 items and stiffness had 2 items, and function had 17 items. The total score for pain ranged from 0 no pain to 50 worst pain. The total score for stiffness ranged from 0 no stiffness to 20 worst stiffness. The total score for function raged from 0 no function to 170 worst function. A higher score indicates a better health state improvement.|5 years|1 datapoint not made available from 1 patient out of 34 patients in the Experimental group|||Percentage change||Standard Deviation|Least Squares Mean
1402057|NCT01246895|Primary|Repair Tissue Quality (T2 MRI)|Tissue quality of the repair tissue as measured by T2 MRI as an index for collagen-based structure.|5 years|5 aberrant imaging datapoint from 5 patients out of 34 patients were removed from the Experimental group and 4 aberrant imaging datapoint from 4 patients out of 34 patients were removed from the Control group|||T2 relaxation time (ms)||Standard Deviation|Least Squares Mean
1402058|NCT01246895|Primary|Degree of Lesion Filling (%Fill) by Repair Tissue at Degree of Lesion Filling (%Fill) by Repair Tissue at 5 Years Through MRI.|Degree of lesion filling (repair tissue volume) as measured by quantitative MRI at 5 Years post-treatment compared to the debrided lesion 1-month post-treatment (baseline).|5 years|33 out of 34 BST-CarGel with percentage lesion filled measurement. 1 aberrant imaging datapoint from 1 patient out of 34 patients was removed from the Experimental group|||Percentage of lesion filled (%)||Standard Deviation|Least Squares Mean
1402059|NCT01246791|Primary|Elimination Rate Constant (Kel) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hr^-1||Standard Deviation|Mean
1402060|NCT01246791|Primary|Elimination Rate Constant (Kel) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of elimination rate constant (kel) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hr^-1||Standard Deviation|Mean
1402061|NCT01246791|Primary|Mean Residence Time (MRT) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
1402062|NCT01246791|Primary|Mean Residence Time (MRT) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of mean residence time (MRT) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
1402063|NCT01246791|Primary|Plasma Half Life (t1/2) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
1402064|NCT01246791|Primary|Plasma Half Life (t1/2) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of plasma Half life (t1/2) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
1402065|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
1402097|NCT01246206|Secondary|Estimate Incidence of Chronic GVHD at Two Years|Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks|Followed for up to two years post transplant|All participants|||percentage of participants||95% Confidence Interval|Number
1402066|NCT01246791|Primary|Time to Peak Plasma Concentration (Tmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of time to peak plasma concentration (Tmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||hours||Standard Deviation|Mean
1402067|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||pg/mL||Standard Deviation|Mean
1402068|NCT01246791|Primary|Peak Plasma Concentration (Cmax) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of peak plasma concentration (Cmax) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||ng/mL||Standard Deviation|Mean
1402069|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Ethinyl Estradiol of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of ethinyl estradiol that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||pg･hr/mL||Standard Deviation|Mean
1402070|NCT01246791|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) on Norethisterone of NPC-01|Multiple blood samples will obtains at pretreatment(0 hour), 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0 and 24.0 hours after dosing of NPC-01(1mg norethisterone and 0.02mg ethinyl estradiol) and determination of area under the plasma concentration versus time curve (AUC) of norethisterone that are active substances of NPC-01.|0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 9.0, 12.0, 24.0 hours after single dosing of NPC-01||||ng･hr/mL||Standard Deviation|Mean
1402071|NCT01246713|Primary|Acetaminophen Metabolites|Area-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose.|8 hours||||mcg.hr/ml||Standard Error|Mean
1402072|NCT01246479|Secondary|Rate of Subjects With AEs and Medically Attended AEs up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322). Severity, Duration and Relationship to Vaccinations.|Rate of subjects with AEs and medically attended AEs up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322). Severity, duration and relationship to vaccinations.|Months 12, 24 and 36|||||||
1402073|NCT01246479|Secondary|Rate of Subjects With SAEs Following Immunization up to Months 12, 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with SAEs following immunization up to Months 12, 24 and 36 after the first IC51 vaccination (in study IC51-322)|Months 12, 24 and 36|||||||
1402074|NCT01246479|Secondary|GMTs and Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Months 24 and 36 After the First IC51 Vaccination (in Study IC51-322)|GMTs and rate of subjects with PRNT50 titers of ≥ 1:10 at Months 24 and 36 after the first IC51 vaccination (in study IC51-322)|Month 24, 36|||||||
1402075|NCT01246479|Secondary|GMT for JEV Neutralizing Antibodies Measured Using the PRNT at Month 12 After the First IC51 Vaccination (in Study IC51-322)|GMT for JEV neutralizing antibodies measured using the PRNT at Month 12 after the first IC51 vaccination (in study IC51-322)|Month 12|||||||
1402076|NCT01246479|Primary|Rate of Subjects With PRNT50 Titers of ≥ 1:10 at Month 12 After the First IC51 Vaccination (in Study IC51-322)|Rate of subjects with PRNT50 titers of ≥ 1:10 at Month 12 after the first IC51 vaccination (in study IC51-322)|Month 12|intention to treat population; assessment of seroprotection ~1 year post primary vaccination series in parent study IC51-322|||percentage of participants||95% Confidence Interval|Number
1402077|NCT01246401|Secondary|ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX|The arm/group number of the participants vary from the primary outcome because this is a treatment effect analysis. All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.|6 months|All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.|||Participants|||Count of Participants
1402078|NCT01246401|Secondary|Opioid Abstinence at 6 Months for Those With More Than 4 Injections|Based on self reported opioids (heroin) use. All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections were compared to those who receive 4 or more XR-NTX injection.|6 months|Collected via Time Line Fall Back (TLFB). Total N analyzed is 74. 12 of the clients had initial or some TLFB data indicating relapse but were counted as lost at 6 months for outcome 4. 19 Clients did not have TLFB data or if they did within 6 month it did not indicate any relapse. These were treated as missing and not included in analysis.|||Participants|||Count of Participants
1402079|NCT01246401|Secondary|Participants With Opiate Abstinence Via By Doing Urine Toxicology Test|Percent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive).|6 month||||Participants|||Count of Participants
1402080|NCT01246401|Secondary|Antiretroviral Therapy (ART) Adherence 100%|Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100%|6 months|56 participants with missing data were considered as failure - meaning - with adherence less than 100%, and included into the analysis.|||Participants|||Count of Participants
1402081|NCT01246401|Secondary|Craving for Opioids|Craving at baseline compared to 6 month. This is assessed through a self report scale rated 0 to 10; 0 meaning not craving and 10 meaning highest craving. Change in craving score was categorized as 1)no change between baseline and 6 month; 2)increased craving - baseline craving was reported lower than at 6 month; 3)decreased craving - baseline craving was reported higher than 6 month craving.|6 months|Data available at 6 month determined who was included into the analysis. In this case a total of 47 data points (those with both baseline and 6 month data points) were included into the analysis (32 Extended-Release Naltrexone and 15 Placebo).|||Participants|||Count of Participants
1402082|NCT01246401|Secondary|Addiction Severity|"The Addiction Severity Index (ASI) questionnaire will be used to assess addiction severity. The ASI composite scoreprovides reliable and valid measure of patient status in a particular module of interest which can then be usecompared at the beginning of treatment to the evaluation endpoint to note the improvement or lack thereof. In this assessment the drug composite score was calculated using algorithm by Treatment Research Institute. If the score increases then it shows increase in severity where as if it decreases then it shows decrease in severity for that measured module. The scale ranges from 0 to 1.~The mean composite scores for drug use from baseline to 6 months were compared using Nonparametric test."|baseline, and 6 months|An additional subject's data from the experimental group was not collected at baseline. For the 6 months data, the total number of participants with completed assessment used for the analysis was 46 (31 in XR-NTX group and 15 in Placebo group).|||units on a scale||Standard Deviation|Mean
1402083|NCT01246401|Secondary|Time to Opioid Relapse or End of Intervention|Measuring days to first relapse based on self reported opioids (heroin) use within the 6 month (180 days) intervention period. If participants had no follow-up visits, and thus no self reported opiate use, they were treated as missing. Those who did not relapse within the 6 month intervention period were treated as having 180 days until relapse.|6 months|Data collected via Time Line Fall Back (TLFB). 15 in XR-NTX group and 4 in Placebo did not have data because of attrition - treated as missing. An additional 19 people in the treatment arm and 9 in placebo filled out the TLFB at 9 or 12 months, and this data was used to fill in missing information.|||days||Full Range|Median
1402084|NCT01246401|Secondary|CD4 Cell Count (Cells/mL)|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additional labs will be drawn every 3 months for 1 year to monitor changes in CD4 levels.|Baseline and 6 months|Data was collected via labs. At month 6, due to attrition, data was only available for a total of 46 subjects. These include, 14 in Placebo and 32 in Extended-Release Naltrexone. The mean and STD are presented below.|||cells/ml||Standard Deviation|Mean
1402085|NCT01246401|Secondary|Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.|6 months|A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.|||Participants|||Count of Participants
1402086|NCT01246401|Primary|Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month|Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.|6 months|A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.|||Participants|||Count of Participants
1402087|NCT01246349|Primary|Child Dietary Self-Efficacy Scale|"A second self-efficacy scale, the Child Dietary Self-Efficacy Scale (CDSS; Parcel et al., 1995) was used to measure participants' confidence in their ability to choose lower fat, lower sodium foods.~The questionnaire is made up of 20 likert items with 3 response options, including not sure, a little sure, and very sure. Each item asks the participant to indicate how sure he/she is that they would make a healthy choice, for example, How sure are you that you could eat cereal instead of a donut? Individual items are scored -1, 0, or 1 and subsequently summed for a total score, with the lowest possible score a -20 and the highest a 20, whereby higher scores signify higher dietary self efficacy."|Baseline, 6 month follow-up||||scores on a scale||Standard Deviation|Mean
1402088|NCT01246349|Secondary|Psychological Well-being|Rosenberg Self-Esteem scale, Pediatric Quality of Life Inventory (PEDS QL), Child depression inventory, Adolescent coping (A-COPE)|Change over time from Baseline to 6 months (measured monthly) with a 12 months reassessment|||||||
1402089|NCT01246349|Secondary|Physiological Outcomes: Waist Circumference|Measurements of waist circumference, an indirect measure of central adiposity (or fatness), were also obtained.|Baseline, 6 month follow-up||||cm||Standard Deviation|Mean
1402090|NCT01246349|Secondary|Physiological Outcomes: BMI|The study used a Body Mass Index (BMI) percentile for age as the main indicator of weight-loss. Height and weight was measured by the pediatrician at the treatment site and BMI as well as BMI percentile for age was determined with the use of an age appropriate growth curve chart.|Baseline, 6 month follow-up||||z-score||Standard Deviation|Mean
1402091|NCT01246349|Primary|Weight Efficacy Life-style Questionnaire|"A self-efficacy instrument, the Weight Efficacy Life-style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991) was used to measure participants' beliefs about and confidence in their own ability to make a behavior change, specifically their ability to lose weight.~The questionnaire yields a total score, with higher scores indicating higher levels of health-related self-efficacy, as well as 5 situational sub-scores (negative emotions, availability, social pressure, physical discomfort, and positive activities). Individuals rate statements on a 10-point scale ranging from 0 (not confident) to 9 (very confident).~The WEL is made up of 20 items (4 items per sub-scale) which are summed to obtain a total score, with the lowest total score possible being 0 and the highest 180. Only the total WEL score was used in the study's analyses.~The difference in self-efficacy (WEL) change between treatment and control groups from baseline to a 6 month follow-up was examined."|Baseline, 6 month follow-up||||scores on a scale||Standard Deviation|Mean
1402092|NCT01246258|Other Pre-specified|Utricular Centrifugation Test (UCF)|balance assessment|one day||||participants|||Number
1402093|NCT01246258|Primary|Vestibular Evoked Myogenic Potentials (VEMPs)|These are the balance tests that specifically assess the otolith organ.|one day||||participants|||Number
1402094|NCT01246206|Secondary|Determine Time to Engraftment (“PLT20”)|The number of days until engraftment (“PLT20”)|Followed for up to two years post transplant|All paarticipants|||days||Full Range|Median
1402095|NCT01246206|Secondary|Determine Time to Engraftment (“G500”)|The number of days until engraftment (“G500”)|Followed for up to two years post transplant|All paarticipants|||days||Full Range|Median
1402102|NCT01246076|Secondary|Time to Progression|The time to progression is defined as the time from registration to the date of progression or last follow-up. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred.|Up to 6 months after completion of treatment (up to 82 weeks from start of treatment)|Time to progression was not analyzed. This was a prespecified secondary outcome but due to the early termination of the study time to progression was not followed.||||||
1402103|NCT01246076|Secondary|Toxicity as Measured by Number of Participants Who Experienced Related Grade 3-5 Adverse Events Based on CTCAE Version 4||30 days after end of treatment (up to 60 weeks)||||participants|||Number
1402104|NCT01246076|Secondary|Time to Discontinuation of Treatment||Up to 56 weeks (14 cycles)|16 out of 24 participants were evaluable for this outcome measure as these 16 participants completed at least the first cycle of treatment.|||cycles||Full Range|Median
1402105|NCT01246076|Secondary|Duration of Response||Until 6 months after end of treatment|8 participants had a response -- all had MCR.|||days||Full Range|Median
1402106|NCT01246076|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who were alive 6 months after end of treatment.|6 months after end of treatment (up to 82 weeks from start of treatment)||||percentage of participants|||Number
1402107|NCT01246076|Primary|Number of Participants With Confirmed Responses (Complete Remission, Partial Remission, or Hematologic Improvement) as Defined by the International Working Group Criteria|"Complete remission (CR): ≤5% myeloblasts bone marrow blasts, normal maturation in all cell lines (dysplasia will be noted), ≥11 g/dl peripheral blood hemoglobin, ≥100x10^9cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood absolute neutrophil count (ANC), and 0% peripheral blood blasts.~Marrow complete remission (MCR): ≤5% myeloblasts and decreased by ≥50% compared to pre-treatment bone marrow blasts, bone marrow morphology not relevant, and peripheral blood (if hematological improvement they will be noted in addition to marrow CR).~Partial remission (PR): previously had ≥5% myeloblasts and now have ≥5% myeloblasts but decreased by ≥50% compared to pre-treatment, bone marrow morphology not relevant, ≥11 g/dl peripheral blood hemoglobin, ≥100x109cells/μL peripheral blood platelets, ≥1000 cells/ μL peripheral blood ANC, and 0% peripheral blood blasts"|Up to 56 weeks (14 cycles of treatment)|8 participants were not evaluable for this outcome measure because they did not complete at least one cycle of therapy.|||participants|||Number
1402108|NCT01246011|Secondary|Major Bleeding Events.|Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL.|At 2weeks post CABG|No analysis will be done due to early study termination.||||||
1402109|NCT01246011|Primary|Coronary Artery Bypass Vein Graft Patency|Vein graft patency as measured by computed tomography|Approximately 30 Days post CABG|No analysis will be done due to early study termination||||||
1402110|NCT01245764|Secondary|GMT of Anti-HPV Type 18 Antibody|Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1402111|NCT01245764|Secondary|GMT of Anti-HPV Type 16 Antibody|Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1402112|NCT01245764|Secondary|GMT of Anti-HPV Type 11 Antibody|Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1402113|NCT01245764|Secondary|Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody|Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
1402114|NCT01245764|Primary|Number of Participants With Serious Adverse Experiences|A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention|From the time of informed consent is signed through the last study visit (up to 19 months)|The analysis included all participants receiving at least 1 vaccination in study Phase A or B and who had postvaccination follow-up|||Participants|||Number
1402115|NCT01245764|Primary|Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)||Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had temperature data|||Participants|||Number
1402116|NCT01245764|Primary|Number of Participants With Injection-site Adverse Experiences|Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences|Up to Day 5 after any vaccination in study Phase A|The analysis included all participants receiving at least 1 vaccination in study Phase A and who had postvaccination follow-up|||Participants|||Number
1402203|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 72|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 72|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402117|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 18|Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of >=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
1402118|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 16|Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
1402119|NCT01245764|Primary|Number of Participants Who Seroconvert to HPV Type 11|Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of >=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
1402120|NCT01245764|Primary|Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6|Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of >=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.|Month 7 (1 month postdose 3 in study Phase A)|Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.|||Participants|||Number
1402121|NCT01245751|Secondary|Number of Participants Reporting One or More Adverse Experiences|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.|Up to 42 days postvaccination|Analysis included all vaccinated participants who had any safety follow-up|||Participants|||Number
1402122|NCT01245751|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 only.|||Fold Rise||95% Confidence Interval|Geometric Mean
1402123|NCT01245751|Primary|Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 (Baseline) and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only.|||gpELISA Units/mL||95% Confidence Interval|Geometric Mean
1402124|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C But Did Not Achieve Target Lipid Levels for TG and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
1402125|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG But Did Not Achieve Target Lipid Levels for HDL-C and LDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
1402126|NCT01245738|Primary|Percentage of Participants Who Did Not Achieve Target Lipid Levels for LDL-C, HDL-C, and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
1402127|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels of HDL-C and LDL-C But Did Not Achieve Target Lipid Levels for TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
1402886|NCT01239394|Secondary|Progression-free Survival (PFS)|Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse|12 months||||percentage of patients||95% Confidence Interval|Number
1402128|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for TG and LDL-C But Did Not Achieve Target Lipid Levels for HDL-C After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements and Week 12.|||Percentage of Participants|||Number
1402129|NCT01245738|Primary|Percentage of Participants Who Achieved Target Lipid Levels for LDL-C But Did Not Achieve Target Lipid Levels for HDL-C and TG After 12 Weeks of Treatment With Statins|The percentage of participants who achieved predefined lipid target levels after 12 weeks of treatment with statins. Predefined lipid target levels were: LDL-C less than 70 mg/dL, HDL-C greater than 40 mg/dL, and TG less than 150 mg/dL.|Week 12|Participants of the FAS Population who had HDL-C, TG, and LDL-C measurements at Week 12.|||Percentage of Participants|||Number
1402130|NCT01245738|Primary|Change From Baseline in TG Levels After 12 Weeks of Treatment With Statins|TG levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between Baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had TG measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
1402131|NCT01245738|Primary|Change From Baseline in HDL-C Levels After 12 Weeks of Treatment With Statins|HDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had HDL-C measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
1402132|NCT01245738|Primary|Change From Baseline in LDL-C Levels After 12 Weeks of Treatment With Statins|LDL-C levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the FAS Population who had LDL-C measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
1402133|NCT01245738|Primary|Change From Baseline in TC Levels After Treatment|TC levels were measured after 12 weeks of treatment with a statin. The change from baseline was calculated as the difference between baseline and Week 12 values.|Baseline and at Week 12|Participants of the Full Analysis Set (FAS) Population who had a TC measurements at baseline and Week 12.|||mg/dL||Standard Deviation|Mean
1402134|NCT01245738|Primary|Triglycerides (TG) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TG levels of eligible participants were taken. This level was considered the baseline value. A TG level of >150 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a TG measurement at baseline.|||mg/dL||Standard Deviation|Mean
1402135|NCT01245738|Primary|High-Density Lipoprotein Cholesterol (HDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the HDL-C levels of eligible participants were taken. This level was considered the baseline value. A HDL-C level of <40 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a HDL-C measurement at baseline.|||mg/dL||Standard Deviation|Mean
1402136|NCT01245738|Primary|Low-Density Lipoprotein Cholesterol (LDL-C) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the LDL-C levels of eligible participants were taken. This level was considered the baseline value. A LDL-C level of >70 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a LDL-C measurement at baseline.|||mg/dL||Standard Deviation|Mean
1402137|NCT01245738|Primary|Total Cholesterol (TC) Levels at First Acute Coronary Event|At the time of hospital admission for a first acute coronary event, the TC levels of eligible participants were taken. This level was considered the baseline value. A TC level of >240 mg/dL is considered an abnormal lipid value (dyslipidemia).|At hospital presentation (Day 1)|Participants who had a total cholesterol measurement at baseline.|||mg/dL||Standard Deviation|Mean
1402138|NCT01245647|Secondary|CD4 Count (Mean)|Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.|4 months||||CD4 count (cells/ml)||Standard Deviation|Mean
1402139|NCT01245647|Secondary|HIV Viral Load Suppressed|Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)|4 months||||percentage of persons with suppressed VL|||Number
1402140|NCT01245647|Secondary|Risky Sexual Behaviors|Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.|4 months||||percentage of persons with risky sex|||Number
1402141|NCT01245647|Secondary|HIV Medication Adherence (95% or Better)|Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.|Month 4|Only persons who reported current HIV medication use (n=13) were considered for this outcome, and we included data from the 12 persons who completed the 4-month assessment.|||percentage of participants|||Number
1402142|NCT01245647|Primary|Number of Drinks Per Week|Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.|Month 4|All participants who provided data at the 4-month follow-up were included (n=15), which is 79% of persons who were randomized.|||standard alcohol drinks per week||Standard Deviation|Mean
1402143|NCT01245595|Primary|Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria|Acute Kidney Injury measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine criteria; KDIGO Stage is a measure of acute kidney injury.|5 days||||participants|||Number
1402245|NCT01245270|Secondary|Bioavailability in Urine|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Urine will also be collected (if possible) 0, 1, 3 and 5 hours, with all urine collected within the 24 hour time period post intervention||2018-08-31|08/2018||||
1402144|NCT01245439|Secondary|Health Assessment Questionnaire Score (General Score)|The Stanford HAQ disability index is a participant completed questionnaire specific for RA. It consists of 20 questions referring to 8 component sections: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in validated translation into the local languages at the participating sites and was scored. Every question in each section was scored at a scale from 0 to 3 by the participant where 0 = able to perform the activity without any difficulty and 3 = unable to perform the activity. General score was calculated as an average of the 8 sections.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||units on a scale||Standard Deviation|Mean
1402145|NCT01245439|Secondary|Participant's Assessment of Pain|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||mm||Standard Deviation|Mean
1402146|NCT01245439|Secondary|Participant's (PT) and Investigator's (IN) Assessment of Disease Activity|VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||mm||Standard Deviation|Mean
1402147|NCT01245439|Secondary|Mean Number of Tender and Swollen Joints|Participants were asked to classify 28 joints as tender or not tender and swollen or not swollen to count the total number of tender and swollen joints by visit.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population|||joints||Standard Deviation|Mean
1402148|NCT01245439|Secondary|Erythrocyte Sedimentation Rate|ESR is an inflammatory marker used to measure inflammation in RA and is measured as millimeters per hour (mm/hr).|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category|||mm/hr||Standard Deviation|Mean
1402149|NCT01245439|Secondary|C-Reactive Protein Levels|CRP is an inflammatory marker used to measure inflammation in RA and is measured as mg/dL.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.|||mg/dL||Standard Deviation|Mean
1402150|NCT01245439|Secondary|Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: ≥ 20/50/70/90 % improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. .|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.|||Percentage of participants|||Number
1402151|NCT01245439|Secondary|Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response|ACR20/50/70/90 response: greater than or equal to (≥) 20/50/70/90 percent (%) improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit.|Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population; number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
1402152|NCT01245439|Secondary|Disease Activity Score as Measured By DAS28 at Each Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. n = participants who were evaluable for specified category|||units on a scale||Standard Deviation|Mean
1402153|NCT01245439|Secondary|Percentage of Participants Achieving Their First Remission Status By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Percentage of participants|||Number
1402154|NCT01245439|Secondary|Percentage of Participants Who Achieved Remission (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.|||percentage of participants|||Number
1402155|NCT01245439|Secondary|Number of Participants Who Achieved Remission (DAS28) By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category|||participants|||Number
1402156|NCT01245439|Secondary|Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome|||Percentage of participants|||Number
1402157|NCT01245439|Secondary|Percentage of Participants Who Achieved LDA By Visit|"TThe DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.|||percentage of participants|||Number
1402158|NCT01245439|Secondary|Number of Participants Who Achieved LDA By Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: <3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.|||participants|||Number
1402184|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 30|Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 30|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402185|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 24|Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 24|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402159|NCT01245439|Secondary|Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit|"The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of: < 3.2 represents LDA, and a score of > 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.|||percentage of participants|||Number
1402160|NCT01245439|Secondary|Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit|"The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula:~DAS28 = 0.56 x (TJC28)^0.5 + 0.28 x (SJC28)^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of less than (<) 2.6 represents clinical remission, a score of: <3.2 represents low disease activity (LDA), and a score of > 5.1 represents severe disease. A reduction from previous visit of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement."|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Intent- to- Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category|||participants|||Number
1402161|NCT01245439|Secondary|Percentage of Participants With Elevations in Lipids According to ATP III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL , Total cholesterol >240 mg/dL, HDL >60 mg/dL and TG >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; n = number of participants analyzed at the specified visit for the given parameter.|||percentage of participants|||Number
1402162|NCT01245439|Secondary|Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines|ATP III guidelines classify LDL cholesterol >160 mg/dL, Total cholesterol >240 mg/dL, High Density Lipoprotein (HDL) >60 mg/dL and Triglycerides (TG) >199 as elevated.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population; Number (n) equals (=) number of participants analyzed at the specified visit for the given parameter.|||participants|||Number
1402163|NCT01245439|Secondary|Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)|ANC is a measure of number of neutrophil granulocytes. An ANC less than 500 cells per microliter (cells/µL) is defined as neutropenia and significantly increases risk of infection. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline. ANC was measured in cells/µL.|Baseline to Week 24|Safety population|||cells/µL||Standard Deviation|Mean
1402164|NCT01245439|Secondary|Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol|Elevations in LDL and total cholesterol could lead to heart disease. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline and was measured as milligrams per deciliter (mg/dL).|Baseline to Week 24|Safety population; number of participants analyzed signifies participants who were evaluable for this outcome.|||mg/dL||Standard Deviation|Mean
1402165|NCT01245439|Secondary|Change From Baseline to Highest Values for ALT and AST|Elevations in ALT and AST could indicate hepatotoxicity. These enzymes were measured as International Units per Liter (IU/L). The change from baseline was calculated as: baseline value minus the highest value observed post-baseline for each enzyme.|Baseline to Week 24|Safety population|||IU/L||Standard Deviation|Mean
1402166|NCT01245439|Secondary|Number of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population|||participants|||Number
1402167|NCT01245439|Secondary|Percentage of Participants With Serious Infections|A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly|Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)|Safety population|||percentage of participants|||Number
1402168|NCT01245439|Secondary|Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population|||percentage of participants|||Number
1402169|NCT01245439|Secondary|Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN|Elevations in ALT and AST could indicate hepatotoxicity.|Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)|Safety population|||participants|||Number
1402170|NCT01245439|Secondary|Percentage of Participants With All-Cause Discontinuation|Participants who discontinued treatment due to any reason were included in this measure.|24 weeks|Safety population|||percentage of participants|||Number
1402171|NCT01245439|Primary|Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.|24 weeks|The safety population consisted of all participants included in the study who received at least one dose of study medication and who had at least one post-baseline assessment of safety (that is post-baseline laboratory data, vital signs or adverse events).|||percentage of participants|||Number
1402172|NCT01245413|Primary|Visual Inspection of Baseplate Loosening|The area of the adhesive that was detached from the skin based on visual evaluation of the Athena and Sensura adhesives on the stomach after 1 hour of cycling at moderate intensity. The evaluation was done by marking the detached areas at the baseplate on a transparent wound tracing sheet with a permanent marker. Subsequently the areas were measured by scanning the tracing sheet and calculating the area with the use of Imagepro image macro which calculates the result in cm^2|1 hour|ITT|||cm^2||Standard Deviation|Mean
1402173|NCT01245387|Other Pre-specified|IOP Mean Difference (Within a Participant)|Average predose minus postdose mean difference in IOP within a participant|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.|||mmHg||Standard Deviation|Mean
1402174|NCT01245387|Other Pre-specified|Change in IOP Between Predose and Postdose Assessment|IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||mmHg||Standard Deviation|Mean
1402175|NCT01245387|Other Pre-specified|Intraocular Pressure (IOP)|IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.|Baseline, every 6 weeks up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||mmHg||Standard Deviation|Mean
1402176|NCT01245387|Other Pre-specified|Treatment Tolerability|Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.|Month 24 or early termination|Safety Set; N=number of participants with evaluable data.|||Participants|||Number
1402177|NCT01245387|Other Pre-specified|Number of Participants With Complications Associated With Injection|Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.|Baseline up to Month 24 or early termination|Safety Set; N=number of participants with evaluable data.|||Participants|||Number
1402178|NCT01245387|Other Pre-specified|Time to First Adverse Event (AE)|Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.|Baseline up to Month 24 or early termination|Safety Set: all participants who received at least 1 Macugen (pegaptanib) injection and provided data post baseline. Data not analyzed due to low number of AEs.|||Days||95% Confidence Interval|Median
1402179|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Last Visit|Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402180|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 54|Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 54|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402181|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 48|Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 48|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402182|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 42|Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 42|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402183|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 36|Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 36|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402186|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 18|Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 18|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402187|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 12|Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 12|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402188|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Week 6|Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Week 6|FAS;N=number of participants with evaluable data.|||Participants|||Number
1402189|NCT01245387|Primary|Number of Participants With Angiographic Subtype Reported at Baseline|Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).|Baseline|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402190|NCT01245387|Primary|Central Retinal Thickness|Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||Micrometers (Mcm)||Standard Deviation|Mean
1402191|NCT01245387|Primary|Number of Participants With PED at Last Visit|PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402192|NCT01245387|Primary|Number of Participants With PED at Week 54|PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 54|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402193|NCT01245387|Primary|Number of Participants With PED at Week 48|PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 48|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402194|NCT01245387|Primary|Number of Participants With PED at Week 42|PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 42|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402195|NCT01245387|Primary|Number of Participants With PED at Week 36|PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 36|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402196|NCT01245387|Primary|Number of Participants With PED at Week 30|PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 30|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402197|NCT01245387|Primary|Number of Participants With PED at Week 24|PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 24|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402198|NCT01245387|Primary|Number of Participants With PED at Week 18|PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 18|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402199|NCT01245387|Primary|Number of Participants With PED at Week 12|PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 12|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402200|NCT01245387|Primary|Number of Participants With PED at Week 6|PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Week 6|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402201|NCT01245387|Primary|Number of Participants With Pigment Epithelial Detachment (PED) at Baseline|PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.|Baseline|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402202|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit|Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.|Month 24 or early termination|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402204|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 66|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 66|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402205|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 60|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 60|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402206|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 54|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 54|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402207|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 48|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 48|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402208|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 42|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 42|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402209|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 36|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 36|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402210|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 30|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 30|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402211|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 24|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 24|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402212|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 18|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 18|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402213|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 12|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 12|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402214|NCT01245387|Primary|Number of Participants With a Change in Activity of Neovascular Membrane at Week 6|Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.|Week 6|FAS; N=number of participants with evaluable data.|||Participants|||Number
1402215|NCT01245387|Primary|Lesion Size (Number of Optic Disc Areas)|Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||number of optic disc areas||Standard Deviation|Mean
1402216|NCT01245387|Primary|Number of Participants With Investigator Assessments of Efficacy|Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.|Month 24 or early termination|FAS; N = number of participants with evaluable data.|||Participants|||Number
1402217|NCT01245387|Primary|Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score|Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.|Baseline, every 6 months up to Month 24 or early termination|FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.|||Scores on a scale||Standard Deviation|Mean
1404215|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Threshold|RA pacing threshold results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month visit|||volts (V)||Standard Deviation|Mean
1402218|NCT01245387|Primary|Visual Acuity (VA)|VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).|Baseline, every 6 weeks up to Month 24 or early termination|Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.|||lines of VA||Standard Deviation|Mean
1402219|NCT01245374|Secondary|Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial||Weeks 0 - 6|The safety set consisted of all participants included in the trial and having taken at least one dose of trial treatment. The adverse events and technical complaints were collected during the treatment period (6 weeks after inclusion).|||participants|||Number
1402220|NCT01245374|Secondary|Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment|The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For two patients, no data available.|||percentage of participants|||Number
1402221|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
1402222|NCT01245374|Secondary|Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection|The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
1402223|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
1402224|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Time Learning|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.|||percentage of participants|||Number
1402225|NCT01245374|Secondary|Ease of Learning Assessed by the Physician or the Nurse: Ease of Training|The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
1402226|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.|||percentage of participants|||Number
1402227|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.|||percentage of participants|||Number
1402228|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.|||percentage of participants|||Number
1402229|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 6|"Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.~For one patient, no data available."|||percentage of participants|||Number
1402230|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
1402231|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Injection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.|||percentage of participants|||Number
1402232|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Modification|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For seven patients, no data available.|||percentage of participants|||Number
1402233|NCT01245374|Secondary|Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness|The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).|Week 0|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||percentage of participants|||Number
1402234|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Per protocol set (PP): All subjects in the ITT set using NordiFlex® and had completed the trial without any significant violation of the inclusion/exclusion criteria or any other aspect of the protocol considered to potentially affect the efficacy results.|||units on a scale||Standard Deviation|Mean
1402235|NCT01245374|Primary|The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used|Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.|Week 6|Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.|||units on a scale||Standard Deviation|Mean
1402236|NCT01245283|Secondary|Seated Row Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
1402237|NCT01245283|Secondary|Shoulder Press Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
1402238|NCT01245283|Secondary|Chest Press; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
1402239|NCT01245283|Secondary|Leg Curl Test; Change From Baseline at 4 Months|Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
1402240|NCT01245283|Secondary|Leg Extensions Test; Change From Baseline at 4 Months|Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
1402241|NCT01245283|Secondary|Leg Press Test; Change From Baseline at 4 Months|Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.|Baseline, 4 Months||||foot x pounds||Standard Deviation|Mean
1402242|NCT01245283|Secondary|Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months|Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.|Baseline, 4 Months||||Seconds||Standard Deviation|Mean
1402243|NCT01245283|Secondary|Six Minute Walk Test; Change From Baseline at 4 Months|Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.|Baseline, 4 Months||||feet||Standard Deviation|Mean
1402244|NCT01245283|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months|"The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status.~Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible).~0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)"|Baseline, 4 Months||||units on a scale||Standard Deviation|Mean
1402246|NCT01245270|Secondary|Bioavailability in Plasma|To measure the amount of anthocyanins and phenolic-derived metabolites by liquid chromatography mass spectrometry (LC-MS) being absorbed from the gut and excreted following the single intervention.|Plasma will also be collected -15,-10, -5, 15, 30, 45, 60, 90, 120, 150, and 300 minutes and 24 hours post intervention||2018-09-30|09/2018||||
1402247|NCT01245270|Primary|Plasma Insulin iAUC (Incremental Area Under the Curve; ng/ml*Min)|"Volunteers were fasted (10–12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at –15, –10 and –5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61•9%; polysaccharide, 49•2~%; sugars, 12•2%; glucose, 0•6%; maltose, 11•6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.~For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after the capsule||||insulin iAUC (ng/ml*min)||Standard Error|Mean
1402248|NCT01245270|Primary|Plasma Glucose iAUC (Incremental Area Under the Curve; mM*Min)|"Volunteers were fasted (10–12 h) overnight before the OGTT. Venous blood samples were taken through an indwelling cannula inserted into a forearm vein at –15, –10 and –5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min after consuming 75 g of Polycal liquid (carbohydrate, 61·9%; polysaccharide, 49·2~%; sugars, 12·2%; glucose, 0·6%; maltose, 11·6%; http://www. nutricia.co.uk). Polycal was selected as the main carbohydrate as it is in the form of polysaccharides and this is closer to normal dietary consumption than glucose only.The volunteers consumed the appropriate capsule (0 min), glucose load and a further sample of water (70 ml) within 3 min.~For those volunteers taking the control capsule, additional sugar (fructose and dextrose/glucose) was added double-blinded to the water to match the free sugar content of the Mirtoselect® capsules. Movement during the 300 min OGTT was kept to a minimum."|Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post capsule||||glucose iAUC (mM*min)||Standard Error|Mean
1402249|NCT01245140|Secondary|Number of Participants With a Negative Serum Pregnancy Test at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|Serum pregnancy tests were performed at each visit for females of childbearing potential.|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); safety follow-up (Week 29)|Safety population. Only female participants were analysed for serum pregnancy test.|||Participants|||Number
1402250|NCT01245140|Secondary|Number of Participants With Normal/Abnormal Physical Status at Baseline With a Worst Post-Baseline Finding of Normal/Abnormal|A physical examination for each participant was performed at Baseline and at EOT (Week 24). The primary investigator classified physical status as either normal or abnormal.|Baseline and EOT (Week 24)|Safety Population|||Participants|||Number
1402251|NCT01245140|Secondary|Change From Baseline in Weight at EOT (Week 24)|Change from Baseline is defined as the value at EOT minus the value at Baseline.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.|||kg||Standard Deviation|Mean
1402252|NCT01245140|Secondary|Change From Baseline in Heart Rate at EOT (Week 24)|HR is defined as the rate at which the heart beats. Change from Baseline is defined as the value at EOT minus the Baseline value.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.|||bpm||Standard Deviation|Mean
1402253|NCT01245140|Secondary|Change From Baseline in SBP and DBP at EOT (Week 24)|Change from Baseline is defined as the value at EOT minus the Baseline value.|Baseline and EOT (Week 24)|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1402254|NCT01245140|Secondary|Mean Body Weight at Screening, Baseline ,and EOT (Week 24)|Body weight was measured at Screening, Baseline, and EOT.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Kilograms (kg)||Standard Deviation|Mean
1402255|NCT01245140|Secondary|Mean Heart Rate (HR) at Baseline, Screening, and EOT (Week 24)|HR is defined as the rate at which the heart beats.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Beats per minute (bpm)||Standard Deviation|Mean
1402256|NCT01245140|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Screening, Baseline, and EOT (Week 24)|SBP and DBP were assessed at Screening, Baseline, and EOT.|Screening, Baseline, and EOT (Week 24)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1402257|NCT01245140|Secondary|Absolute Change From Baseline in the CSSRS Score at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24); and safety follow-up (Week 29). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
1402303|NCT01245049|Secondary|Anti-measles Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1403152|NCT01236196|Primary|Level of Functioning|Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1402258|NCT01245140|Secondary|Mean Columbia Suicide Severity Rating Scale (CSSRS) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The assessment of suicidality was conducted using the CSSRS, a brief questionnaire designed to assess severity and change in suicidality using a semi-structured interview to probe participant responses. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation. CSSRS scores were reported at Screening; Baseline; Week 4, 8, 12, 16, 20; EOT (Week 24);and safety follow-up (Week 29).|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24), and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
1402259|NCT01245140|Secondary|Absolute Change From Baseline (BL) in CES-D Scores at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of >=20 were re-evaluated within 2 weeks. If a CES-D score of >=20 was confirmed on the second occasion, and if the score represents an increase over BL of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation. Change from BL is defined as the post-BL value minus the BL value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
1402260|NCT01245140|Secondary|Mean Center for Epidemiological Studies Depression Scale (CES-D) Scores at Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and Safety Follow-up (Week 29)|The CES-D scale is a short, self-report scale designed to measure depressive symptomatology in the general population. The CES-D consists of 20 questions. Participants were instructed to circle the number for each statement that best described how often they felt or behaved a particular way during the past week. The score was the sum of the weights of the 20 items. Responses range from 0 to 3 for each item (0=rarely or none of the time, 1=some or little of the time, 2=moderately or much of the time, 3=most or almost all the time). The CES-D score ranges from 0 to 60, with higher scores indicating greater depression. Participants with a CES-D score of 20 or higher were re-evaluated within 2 weeks. If a CES-D score of 20 or higher was confirmed on the second occasion, and if the score represents an increase over Baseline of 4 points or more, study treatment was interrupted and the participants were referred for psychiatric evaluation.|Screening; Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
1402261|NCT01245140|Secondary|Number of Participants With the Indicated Shift in the Indicated Laboratory Values From Baseline (BL) to EOT (Week 24)|Laboratory parameters included triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, LDL/HDL ratio, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and amylase and lipase. The central laboratory classified a finding as either abnormal or normal.|From Baseline until EOT (Week 24)|Safety Population|||Participants|||Number
1402262|NCT01245140|Secondary|Absolute Change From Baseline in Fasted LDL/HDL Ratio at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)|Change from Baseline is defined as the value at the safety follow up visit minus baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24) and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Ratio||Standard Deviation|Mean
1402263|NCT01245140|Secondary|Absolute Change From Baseline in Fasted Lipid Laboratory Test Values at Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and at Safety Follow-up (Week 29)|Fasted lipid laboratory parameters included triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; EOT (Week 24); and safety follow-up (Week 29)|Safety Population. Only participants available at the specified time points were analyzed (n=X, X).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1402264|NCT01245140|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) and an AE/SAE Related to Study Treatment|An AE was any adverse change from the participant’s Baseline (pre-treatment) clinical condition, including intercurrent illness, which occurred during the course of a clinical study after written informed consent had been given, whether considered related to treatment or not. The relationship of AEs to the study treatment was assessed as unrelated, remotely related, possibly related, and probably related. For an AE to be considered serious, it fell into one or more of the following categories: results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, and is a congenital abnormality or birth defect.|From Baseline until safety follow up (Week 29)|Safety Population: all randomized participants who received at least one dose of study medication|||Participants|||Number
1402272|NCT01245140|Primary|Number of Participants With PPPASI 50 Response and PPPASI 75 Response|The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value. PPPASI 50 response and PPPASI 75 response are defined as a 50% and 75% decrease, respectively, in the PPPASI score from Baseline.|From Baseline until EOT (Week 24) or the last assessment|Full Analysis Set|||Participants|||Number
1403153|NCT01236170|Secondary|Wheelchair Activity||over a two week period following baseline|||||||
1402265|NCT01245140|Secondary|Absolute Change From Baseline in NAPSI Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Week 12, and EOT (Week 24)|The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24). Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline, Week 12, and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
1402266|NCT01245140|Secondary|Mean Nail Psoriasis Severity Index (NAPSI) Score for Nail Bed Psoriasis and Nail Matrix Psoriasis at Baseline, Week 12, and EOT (Week 24)|The severity of nail lesions was assessed for all participants with psoriatic nail involvement by obtaining the NAPSI score. Scores were taken for fingernails only. No scores were taken for participants with traumatic or fungal changes in nails. The nail was divided into four quadrants, each of which was rated with a 0 or 1, based on the absence (0) or presence (1) of pathological signs resulting from involvement of both the nail matrix and the nail bed. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of nail psoriasis in that quadrant. Possible scores for matrix and nail bed psoriasis: 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. NAPSI score for nail matrix (0-4) and nail bed (0-4) were reported at Baseline, Week 12, and at the EOT visit (Week 24).|Baseline, Week 12, and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
1402267|NCT01245140|Secondary|Number of Participants With mPASI 50 Response and mPASI 75 Response|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). The fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated. mPASI 50 response and mPASI 75 response is defined as a 50% and 75% decrease, respectively, in the mPASI score from Baseline.|From Baseline until EOT (Week 24)|Full analysis set. Participants with lesions in areas of the body other than the hands and feet were assessed.|||Participants|||Number
1402268|NCT01245140|Secondary|Change From Baseline in the mPASI Score at EOT (Week 24) or at the Last Assessment|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on redness, thickness, and scaliness scores of plaques (0-4 each) for head, upper extremities, trunk, lower extremities and area of psoriatic involvement score (0-6). Lowest possible mPASI score was 0 and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values. Change from Baseline is defined as the value at EOT minus baseline value.|Baseline and EOT (Week 24) or the last assessment|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
1402269|NCT01245140|Secondary|Mean Modified Psoriasis Area Severity Index (mPASI) Score at Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Psoriatic plaques were graded based on three criteria: redness (R), thickness (T), and scaliness (S). Severity was rated for each criterion on a 5-point scale (0=no involvement, up to 4=severe involvement). Fraction of the total surface area affected on the head, upper extremities, trunk, and lower extremities was graded on a 7-point scale (0=no involvement, up to 6=greater than 90% involvement). The four body regions were weighted to reflect their respective proportion of body surface area, and the composite mPASI score for all body regions was calculated based on the redness, thickness, and scaliness scores of plaques (0-4 each) for the head, upper extremities, trunk, and lower extremities and the area of psoriatic involvement score (0-6). The lowest possible mPASI score was zero and highest up to 72; Higher score values represents greater severity of psoriasis. mPASI scores were continuous, with 0.1 increments within these values.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Scores on a scale||Standard Deviation|Mean
1402270|NCT01245140|Secondary|Absolute Change From Baseline (BL) in Total Pustule Count at Weeks 4, 8, 12, 16, and 20 and at EOT (Week 24)|The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the End of Treatment visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole. Change from Baseline is defined as the value at the post-Baseline visit minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Pustule count||Standard Deviation|Mean
1402271|NCT01245140|Secondary|Total Pustule Count at Baseline; Weeks 4, 8, 12, 16, and 20; and at EOT (Week 24)|The overall number of fresh and older pustules on the left and right palms and soles was assessed at Baseline, at each visit during the treatment period (Weeks 4, 8, 12, 16, and 20), and at the EOT visit. The total pustule count was calculated as the sum of the pustule count for the left/right palm and left/right sole.|Baseline; Weeks 4, 8, 12, 16, and 20; and EOT (Week 24)|Full Analysis Set. Only participants available at the specified time points were analyzed (n=X, X).|||Pustule count||Standard Deviation|Mean
1402301|NCT01245049|Secondary|Anti-Polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 0, before the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1402273|NCT01245140|Primary|Change From Baseline in the Palmo-plantar Pustulosis Psoriasis Area and Severity Index (PPPASI) Score at the End of Treatment (EOT) (Week 24) or at the Last Assessment|The investigator evaluated the PPPASI score on a 5-point scale. The parameters of erythema, total number of pustules, and desquamation were scored for the right/left palm and the right/left sole. After correcting the scores for area (based on a 7-point scale) and the site involved (palm or sole), the PPPASI score per palm/sole was produced. The final PPPASI score was calculated as the sum of the PPPASI score for the right sole + the PPPASI score for the left sole + the PPPASI score for the right palm + the PPPASI score for the left palm and ranges from 0 (no palmo-plantar pustulosis psoriasis [PPP]) to 72 (most severe PPP). Change from Baseline is defined as value at the EOT minus the Baseline value.|Baseline and EOT (Week 24) or the last assessment|Full Analysis Set : treated participants with >=1 efficacy result after receiving study medication.|||Scores on a scale||Standard Deviation|Mean
1402274|NCT01245101|Secondary|Markers of Immune Activation|Flow cytometry will be performed in whole blood for analysis of markers of immune activation by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD8+CD38+ cells will be determined as the main outcome measure.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.|||Percentage of activated CD8+CD38+ cells||Standard Deviation|Mean
1402275|NCT01245101|Primary|Episomal HIV cDNA Formation|These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication.|16 weeks|11 of 12 subjects meeting the per protocol definition were analyzed for the Raltegravir then Observation arm. Poor enrollment led to early termination of study before second arm was activated.|||copies/million||Standard Deviation|Mean
1402276|NCT01245062|Secondary|PFS Following Cross-over to Trametinib as Assessed by the Investigator|PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death. PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)|Cross-over Population|||Months||95% Confidence Interval|Median
1402277|NCT01245062|Secondary|DoR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator|DoR is defined as the time from the first documented evidence of CR (disappearance of all extra nodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR data were summarized per RECIST, Version 1.1Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)|Cross-over Population|||Months||95% Confidence Interval|Median
1402278|NCT01245062|Secondary|DoR for All Confirmed Responders (CR or PR) as Assessed by the Independent Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INDA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
1402279|NCT01245062|Secondary|DoR for All Confirmed Responders (CR or PR) as Assessed by the Investigator Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. DoR for the INVA response data was summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
1402280|NCT01245062|Secondary|DoR for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Independent Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the independently-assessed (INDA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
1402281|NCT01245062|Secondary|Duration of Response (DoR) for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Investigator Review|DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause. DoR for the investigator-assessed (INVA) response data were summarized per RECIST, Version 1.1. Only those participants with confirmed response (CR and PR) were analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
1402282|NCT01245062|Secondary|Number of Participants With OR Following Cross-over to Trametinib|OR is defined as the number of participants with evidence of CR (disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib. The evaluation was carried out by the Investigator per RECIST, Version 1.1. Cross-over Population included the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT. Only participants who received at least one dose of Trametinib were included in this population.|Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)|Cross-over Population|||Participants|||Number
1402283|NCT01245062|Secondary|Number of BRAF V600K Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Participants|||Number
1402284|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator|OR is defined as the number of participants with evidence of complete response (disappearance of all extranodal lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Participants|||Number
1402285|NCT01245062|Secondary|Number of Participants With OR as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Participants|||Number
1402286|NCT01245062|Secondary|Number of BRAF V600E Mutation-positive Participants Without a History of Brain Metastases With Overall Response (OR) as Assessed by the Investigator and Independent Review|OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Participants|||Number
1402287|NCT01245062|Secondary|Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases|Overall survival was defined as the time from the date of randomization to the date of death due to any cause. NA indicates data was not available.|Day 1 until death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
1402288|NCT01245062|Secondary|Overall Survival in All Participants|Overall survival was defined as the time from the date of randomization to the date of death due to any cause.|Day 1 until death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
1402289|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
1402290|NCT01245062|Secondary|PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed PFS was summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
1402302|NCT01245049|Secondary|Anti-rubella Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1402291|NCT01245062|Secondary|Progression-free Survival in All Participants|PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death. Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Intend-To-Treat (ITT) Population included all randomized participants regardless of whether or not treatment was administered.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|ITT Population|||Months||95% Confidence Interval|Median
1402292|NCT01245062|Primary|Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.|Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)|Primary Efficacy Population|||Months||95% Confidence Interval|Median
1402293|NCT01245049|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 to Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.|||Participants|||Count of Participants
1402294|NCT01245049|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.|||Participants|||Count of Participants
1402295|NCT01245049|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.|||Participants|||Count of Participants
1402296|NCT01245049|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0–3) follow-up period after booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.|||Participants|||Count of Participants
1402297|NCT01245049|Secondary|Number of Seroconverted Subjects for Anti-mumps|Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 231 units per millilitre (U/mL)].|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402298|NCT01245049|Secondary|Number of Seroconverted Subjects for Anti-measles|Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)].|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402299|NCT01245049|Secondary|Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens|Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402300|NCT01245049|Secondary|Number of Subjects With a Booster Response to PT, FHA and PRN Antigens|Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402304|NCT01245049|Secondary|Anti-mumps Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||U/mL||95% Confidence Interval|Geometric Mean
1402305|NCT01245049|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|At Month 0, before the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1402306|NCT01245049|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1402307|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-rubella Antibody|A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402308|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-mumps Antibody|A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402309|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-measles Antibody|A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402310|NCT01245049|Secondary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402311|NCT01245049|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402312|NCT01245049|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).|Before (Month 0) and one month after (Month 1) the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402313|NCT01245049|Primary|Anti-Polio Virus Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1402314|NCT01245049|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 1, one month after the booster vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1402315|NCT01245049|Primary|Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens|Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)] antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (≥) 0.4 IU/ml]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.|At Month 1, one month after the booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1402316|NCT01244984|Secondary|Number of Rescue Medication Inhalations|Salbutamol inhaler was used as the rescue medication. Participants entered the number of rescue medication inhalations in the patient diary twice daily (morning and evening).|Baseline up to Week 52|ITT Population. The number of participants analyzed depends on the number of participants remaining in the indaicated time period.|||Number of inhalations||Standard Deviation|Mean
1402317|NCT01244984|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods|The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population|||Percentage of rescue free 24-hour period||Standard Deviation|Mean
1403273|NCT01235715|Primary|Change in Hemoglobin on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
1402318|NCT01244984|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the Study Treatment|Participants who were symptom free for 24-hours were assessed. Change from Baseline is calculated as the value at Week 52 minus the value at Baseline.|Baseline up to Week 52|ITT Population|||Percentage of symptom-free days||Standard Deviation|Mean
1402319|NCT01244984|Secondary|Change From Baseline in Asthma Symptom Score During the Study Treatment|The Baseline value was calculated as the mean of all available data recorded during the 7 days immediately prior to Visit 2 (treatment assignment visit). Participants entered their asthma symptom score in the patient diary twice daily (morning and evening). Daytime asthma symptom scores: 0-no asthma symptoms, 1-one episode of short-time asthma symptoms, 2-two or more episodes of short-time asthma symptoms, 3-asthma symptoms occurring during most part of daytime without interference with daily life activities, 4-asthma symptoms occurring during most part of daytime with interference with daily life activities, 5-severe asthma symptoms that disable working or daily life activities. Nighttime asthma symptom scores: 0-no asthma symptoms, 1-one awakening due to asthma symptoms, 2-two or more awakenings due to asthma symptoms, 3-asthma symptoms almost prevented the participant from sleeping, 4-severe asthma symptoms completely prevented from sleeping.|Baseline up to Week 52|ITT Population|||Scores on a scale||Standard Deviation|Mean
1402320|NCT01244984|Secondary|Change From Baseline in Diary Data - Morning (AM) Peak Expiratory Flow (PEF) and Evening (PM) PEF During the Study Treatment|Change from Baseline in AM and PM PEF at 52 weeks of evaluation period during study treatment was recorded in the dairy record card. The Baseline value was calculated as the mean of all available data recorded during the7 days immediately prior to the treatment start date (including Day 1: Day 1 is treatment start date). The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated.|Baseline up to Week 52|ITT Population|||Litres per Minute (L/min)||Standard Deviation|Mean
1402321|NCT01244984|Secondary|Number of Participants With Severe Asthma Exacerbation During the Study Treatment|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|Baseline up to Week 52|ITT Population|||Participants|||Number
1402322|NCT01244984|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Baseline[Week -2], Week 12, 24 and Week 52/WD) in the treatment period. Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal (Abn) findings. Any abnormal ECG, including those that worsen from Baseline, and determined clinically significant by the assessment of the investigator were recorded as CS.|Week 12, Week 24, and Week 52/WD|"ITT Population. . Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1402323|NCT01244984|Secondary|Change From Baseline in Heart Rate (HR)|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Beats/Minute||Standard Deviation|Mean
1402324|NCT01244984|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline (Week 0), Weeks 12, 24 and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 12, Week 24, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1402325|NCT01244984|Secondary|Change From Baseline in the 24-hour Urinary Cortisol Excretion|Urine samples were collected for measurement of urinary cortisol excretion at the following scheduled time points: Baseline (Week 0), Week 24, and Week 52/WD. The 24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline (Week 0), Week 24, and Week 52/WD|Urine cortisol (UC) Population: all participants in the ITT Population from whom urine specimens were collected and who were considered not to have any confounding factors that might affect the analysis of the results of the specimens. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
1402326|NCT01244984|Secondary|Number of Participants for the Indicated Uninalysis Parameters Tested by Dipstick at Baseline (BL), Week 12, Week 24, and Week 52/WD|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace (TRA), 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1402352|NCT01244828|Primary|Change From Baseline in Insulin at Week 52|Blood samples for determination of insulin level were obtained at baseline and during the study. For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||µIU/mL||Standard Deviation|Mean
1402327|NCT01244984|Secondary|Laboratory Parameter of Urine Specific Gravity (USG) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||ratio of urine density to water density||Standard Deviation|Mean
1402328|NCT01244984|Secondary|Laboratory Parameter of Urine Potential of Hydrogen (pH) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Urine samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||pH||Standard Deviation|Mean
1402329|NCT01244984|Secondary|Laboratory Parameter of Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
1402330|NCT01244984|Secondary|Laboratory Parameter of Bilirubin (Direct [BD], Indirect [BI], Total [BT], Creatinine, and Uric Acid at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Micromoles per Liter (µmol/L)||Standard Deviation|Mean
1402331|NCT01244984|Secondary|Laboratory Parameter of Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at BL (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (BL) (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||International unit per liter (IU/L)||Standard Deviation|Mean
1402332|NCT01244984|Secondary|Laboratory Parameter of Albumin and Total Protein (TP) at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||g/L||Standard Deviation|Mean
1402333|NCT01244984|Secondary|Laboratory Parameter of Red Blood Cell Count at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||10^12 per liter (Ti/L)||Standard Deviation|Mean
1402334|NCT01244984|Secondary|Laboratory Parameter of Hematocrit at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Proportions of I||Standard Deviation|Mean
1402335|NCT01244984|Secondary|Laboratory Parameter of Hemoglobin at Baseline (Week -2), Week 12,Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Grams per liter (g/L)||Standard Deviation|Mean
1402336|NCT01244984|Secondary|Laboratory Parameters of Eosinophils, Platelet Count, White Blood Cell (WBC), and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||10^9 per liter (Gi/L)||Standard Deviation|Mean
1402353|NCT01244828|Primary|Change From Baseline in Fasting Glucose at Week 52|Blood samples for determination of fasting glucose level were obtained at baseline and during the study. For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||mmol/L||Standard Deviation|Mean
1402337|NCT01244984|Secondary|Laboratory Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils at Baseline (Week -2), Week 12, Week 24, and Week 52/WD|Blood samples were collected for measurement at the following scheduled time points: Baseline (Week -2), Week 12, Week 24 and Week 52/WD.|Baseline (Week -2), Week 12, Week 24, and Week 52/WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Percentage||Standard Deviation|Mean
1402338|NCT01244984|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAE.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period|||Participants|||Number
1402339|NCT01244906|Secondary|Number of Patients With Overall Survival at 2 Years.||2 years||||participants|||Number
1402340|NCT01244906|Secondary|Number of Patients to Achieve Full Donor Chimerism|Characterize rate of achievement of full donor chimerism|1 year||||participants|||Number
1402341|NCT01244906|Secondary|Number of Patients With Disease Free Survival at 2 Years||2 years||||participants|||Number
1402342|NCT01244906|Secondary|Number of Participants With Non-Relapse Mortality||1 year||||participants|||Number
1402343|NCT01244906|Secondary|Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment|To estimate the incidence of neutrophil and platelet engraftment|Approximately Day 30||||participants|||Number
1402344|NCT01244906|Primary|Incidence of GVHD|To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.|1 year||||participants|||Number
1402345|NCT01244893|Secondary|Bulbar Redness|Scale of 0 increasing to 4. 0=None, 4=Severe Redness|6-8 days after lens wear|Population analyzed consisted of those who were enrolled, randomized, and completed the study.|||units on a scale||Standard Deviation|Mean
1402346|NCT01244893|Secondary|Limbal Redness|Limbal redness was assessed by using a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.|||units on a scale||Standard Deviation|Mean
1402347|NCT01244893|Secondary|Corneal Staining|Corneal staining type was assessed by Investigator using a slit lamp and graded on a 5-point scale; 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.|||units on a scale|eyes|Standard Deviation|Mean
1402348|NCT01244893|Primary|Visual Acuity (VA)|Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values < 0 imply a clinically positive result; while values > 0 infer a clinically negative result.|6-8 days after lens wear|Population analyzed are those who were enrolled, randomized, and completed the study.|||logMAR scale||Standard Deviation|Mean
1402349|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Final Assessment|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.|Baseline up to Week 52|Participants who received at least one dose of study drug and had a baseline and at least one post-baseline PANSS measurement.|||score on a scale||Standard Error|Mean
1402350|NCT01244828|Primary|Change From Baseline in PANSS Total Score at Week 52|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 PANSS measurement.|||score on a scale||Standard Error|Mean
1402351|NCT01244828|Primary|Change From Baseline in Prolactin at Week 52|Blood samples for determination of prolactin level were obtained at baseline and during the study. For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||µg/L||Standard Deviation|Mean
1402382|NCT01244633|Secondary|Hamilton Depression Scale|This is a measure of feelings of depression that the patient might have.|Every 7 days|||||||
1402354|NCT01244828|Primary|Change From Baseline in HbA1c at Week 52|Blood samples for determination of HbA1c were obtained at baseline and during the study. For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||percent||Standard Deviation|Mean
1402355|NCT01244828|Primary|Number of Participants With Extrapyramidal Symptoms|This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for “extrapyramidal syndrome” were treated as extrapyramidal symptoms.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|Participants who received at least one dose of study drug.|||participants|||Number
1402356|NCT01244828|Primary|Change From Baseline in BMI at Week 52|For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||kg/m^2||Standard Deviation|Mean
1402357|NCT01244828|Primary|Change From Baseline in Weight at Week 52|For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.|Baseline and Week 52|Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure.|||kg||Standard Deviation|Mean
1402358|NCT01244815|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q overall score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402359|NCT01244815|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 21|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 21; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of PQ-LES-Q total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402360|NCT01244815|Secondary|Change From Baseline in Children’s Global Assessment Scale (CGAS) Score at Day 21|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 21; improvement in functioning is represented by positive values. This analysis used an LOCF approach; if no Day 21 value was available for a participant, the last available post-baseline on-treatment assessment prior to the Day 21 assessment was used.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of CGAS score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402361|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 21|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CDRS-R total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402383|NCT01244633|Secondary|Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)|This is a standard measure of ADHD severity that is typically used in these types of clinical trials.|Every 7 days|||||||
1402384|NCT01244633|Primary|Yale Global Tic Severity Score|The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.|8 weeks|Subjects completing the study|||units on a scale||Standard Deviation|Mean
1402362|NCT01244815|Secondary|Change From Baseline in CDRS-R Total Score at Day 14|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CDRS-R total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402363|NCT01244815|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score at Day 7|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7 and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CDRS-R total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402364|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402365|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402366|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402367|NCT01244815|Secondary|Change From Baseline in CGI-BP Depression Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the depression component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP depression score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402368|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 21|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402369|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 14|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 14; improvement in symptoms is represented by negative values.|Baseline and Day 14|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 14 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402370|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 7|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 7; improvement in symptoms is represented by negative values.|Baseline and Day 7|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 7 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402371|NCT01244815|Secondary|Change From Baseline in CGI-BP Mania Score at Day 4|The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the mania component of the participant’s bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 4; improvement in symptoms is represented by negative values.|Baseline and Day 4|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 4 value of CGI-BP mania score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402372|NCT01244815|Secondary|Total Y-MRS 50% Responders at Days 4, 7, 14 and 21|A total Y-MRS 50% responder was defined as a participant who had a reduction from baseline to the identified study visit of at least 50% in the Y-MRS total score. The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items, based on the participant’s subjective report of his or her condition over the previous 48 hours and the clinician’s observations during the interview, with the emphasis on the latter. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60 with higher scores indicating greater severity of symptoms. This analysis used a Last-Observation-Carried-Forward (LOCF) approach; if at a given visit no Y-MRS total score was available for determining whether a participant was a responder, the last available post-baseline on-treatment assessment prior to that visit was used.|Baseline and Days 4, 7, 14 and 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included for a visit, a Y-MRS total score must be available for that visit or a prior post-baseline on-treatment visit|||participants|||Number
1402373|NCT01244815|Secondary|Change From Baseline in Clinical Global Impression Scale for Use in Bipolar Disorder (CGI-BP) Overall Score at Day 21|Change from baseline in CGI-BP overall score at Day 21 is the Key Secondary Outcome Measure. The CGI-BP is a clinician-rated instrument for assessing bipolar illness that includes subscales assessing mania and depression. This measure reports one item within the CGI-BP, which is a 7-point scale assessing the severity of the participant’s overall bipolar illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 21 value of CGI-BP overall score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402374|NCT01244815|Primary|Change From Baseline in Y-MRS Total Score at Day 21|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. A severity rating is assigned to each of the 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight), based on the participant’s subjective report of his or her condition over the previous 48 hours and the clinician’s observations during the interview, with the emphasis on the latter. Seven of the 11 items are rated on a scale of 0-4 and 4 of the items are rated on a scale of 0-8, with higher scores indicating greater severity of symptoms. The Y-MRS total score for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. The reported measure is the change from baseline at Day 21; improvement in symptoms is represented by negative values.|Baseline and Day 21|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment Y-MRS total score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 21 value of Y-MRS total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1402375|NCT01244724|Secondary|National Hospital Seizure Severity Scale|Seizure severity score for each seizure type.|12 Weeks|Due to early termination of this study, data were not collected.||||||
1402376|NCT01244724|Primary|Hamilton Depression Scale|Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)|12 weeks||||units on a scale||Standard Deviation|Mean
1402377|NCT01244711|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).|12 weeks|Change in total score on the MADRS from baseline to final visit|||units on a scale|||Number
1402378|NCT01244633|Secondary|Columbia Scale for Suicide Risk|This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.|Every 7 days|||||||
1402379|NCT01244633|Secondary|Safety Assessments|Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.|Every 7 days|||||||
1402380|NCT01244633|Secondary|Clinician Global Impression – Improvement and Severity Scales (CGI)|This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.|End of trial|||||||
1402381|NCT01244633|Secondary|Premonitory Urge for Tics Scale (PUTS-1)|This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.|Every 7 days|||||||
1402385|NCT01244620|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||Liter (L)||Standard Deviation|Geometric Mean
1402386|NCT01244620|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||hours||Standard Deviation|Mean
1402387|NCT01244620|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||mL/minute||Standard Deviation|Geometric Mean
1402388|NCT01244620|Primary|Area Under the Curve of the 24 Hour Dosing Interval (AUC24)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1402389|NCT01244620|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
1402390|NCT01244620|Primary|Trough Plasma Concentrations (Ctrough)|Minimum or “trough”concentrations|Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Geometric Mean
1402391|NCT01244620|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)|Not analyzed due to early study termination.|||hours||Full Range|Median
1402392|NCT01244529|Secondary|New Lens Power Fit Match to Control Lenses|The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||percentage of eyes|eyes||Number
1402393|NCT01244529|Primary|Fit Acceptability|Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||percentage of eyes|eyes||Number
1402394|NCT01244529|Primary|Primary Gaze Lens Movement|Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||percentage of eyes|eyes||Number
1402395|NCT01244529|Primary|Lens Centration Acceptance|Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.|after 15 minutes of contact lens wear|Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.|||eyes|eyes||Number
1402396|NCT01244516|Secondary|Overall Subjective Lens Handling|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=331) and where assigned to these two arms. Analysis is restricted to these two arms for this outcome as specified per protocol.|||CLUE score||Standard Error|Least Squares Mean
1402397|NCT01244516|Primary|Corneal Staining|Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).|||percentage of eyes|Eyes||Number
1402398|NCT01244516|Primary|Overall Subjective Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 2 weeks of contact lens wear|Analysis is on those subjects who completed the study (n=501).|||CLUE score||Standard Error|Least Squares Mean
1402399|NCT01244503|Secondary|Histology -NAS Scoring of Liver Biopsy|"OBT will be compared to histology (including NAS score as described above)and other parameters to develop severity score. Only subjects with biopsy from routine clinical practice will be enrolled.~NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system includes the following components: steatosis, which is scaled from 0-3, lobular inflammation, which is scaled from 0-3 and hepatocellular ballooning, which is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The range of the NAS score is from 0-8."|Up to 6 months||||units on a scale||Standard Deviation|Mean
1402411|NCT01244490|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.|||units on a scale||Standard Deviation|Mean
1402400|NCT01244503|Primary|The Peak Value of the PDR (Percentage Dose Recovery of 13C) of OBT (Octanoate Breath Test)|To assess the ability of the OBT to assess disease severity in patients with suspected NAFLD (non alcoholic fatty liver disease) compared to NAS (Non-alcoholic-steatohepatitis (NASH) Activity Score) scoring system, where steatosis is scaled from 0-3, lobular inflammation is scaled from 0-3 and hepatocellular ballooning is scaled from 0-2. NAS score greater or equal to 5 indicates NASH. The higher the PDR peak, the better the liver health and function.PDR units are percent per hour of 13C dose recovery and describes rate of metabolism. The PDR peak is the highest rate of metabolism the liver reaches.The total range of NAS is 0-8.|1 hour||||PDR peak value (%/hour)||Standard Deviation|Mean
1402401|NCT01244490|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|SP|||participants|||Number
1402402|NCT01244490|Secondary|Structure Side-Effect Questionnaire|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking ‘yes’ on the checklist for each of the events listed. Outcome measure is at 12 weeks for ages 6-12 years and at 15 weeks for ages 13-17 years.|Up to 12 weeks for children aged 6-12 years and up to 15 weeks for adolescents aged 13-17 years|Safety Population|||participants|||Number
1402403|NCT01244490|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Weeks 10/13 - LOCF|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Safety Population defined as of randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
1402404|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 10/13 - LOCF|The WFIRS-P Risk Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402405|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 10/13 - LOCF|The WFIRS-P Social Domain is the mean of 7 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402406|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 10/13 - LOCF|The WFIRS-P Child Self-Concept Domain is the mean of 3 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402407|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 10/13 - LOCF|The WFIRS-P Life Skills Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402408|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 10/13 - LOCF|The WFIRS-P Behavior in School Domain is the mean of 6 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402409|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 10/13 - LOCF|The WFIRS-P Academic Performance Domain is the mean of 4 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402410|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Global Score at Week 10/13 - LOCF|The WFIRS-P Global Score is the mean of 50 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402412|NCT01244490|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.|||percentage of participants|||Number
1402413|NCT01244490|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 10/13 - LOCF|The WFIRS-P Family Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402414|NCT01244490|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 10/13 - LOCF|The WFIRS-P Learning in School Domain is the mean of 10 items, ranging from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. If more than 30% of items used to derive the score were missing, the corresponding score was considered as missing.|||units on a scale||Standard Error|Least Squares Mean
1402415|NCT01244490|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set. Not all subjects in the FAS population had data for this outcome.|||percentage of participants|||Number
1402416|NCT01244490|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 10/13 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.|Baseline and Up to 10 weeks for children aged 6-12 years and up to 13 weeks for adolescents aged 13-17 years|Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of investigational product. If more than 20% of the items used for summing a score were missing, the score was set to missing.|||units on a scale||Standard Error|Least Squares Mean
1402417|NCT01244477|Secondary|PTSD Checklist (PCL)|An instrument measuring a participants self-reported level of PTSD symptoms. PCL scores are the sum of 17 questions. Each is question is scored from 1 (best possible outcome) to 5 (worst possible outcome). The lowest possible PCL score is a 17, indicating no troublesome PTSD symptoms reported. The highest possible PCL score is a 85, indicating the worst degree of PTSD symptoms reported.|Administered each week at weekly group sessions or pre-post treatment as usual|Veterans under 50 years of age diagnosed with PTSD|||PCL Scores||Standard Deviation|Mean
1402418|NCT01244477|Secondary|Behavioral Expression of Trust on the Trust Game|The Investment Ratio (IR) is the amount subjects were willing to invest in a social partner. It is considered a measure of interpersonal trust, and co-operation. It is a ratio ranging from 0 (indicating no willingness to trust a social partner) to 1.0 (willing to totally trust a social partner). It consists of the percentage of total points the subject was willing to invest in a social partner divided by the total points they received for all ten rounds of the trust game. Higher ratio's indicate more trust.|Pre & post a 12 week treatment group|Veterans with PTSD under 50 years of age|||Ratio||Standard Deviation|Mean
1402419|NCT01244477|Primary|The Clinician Administered PTSD Scale (CAPS)|The CAPS is considered the gold standard measure of PTSD symptoms. CAPS scores are the sum of 17 questions. Each is question is scored from 0 (best possible outcome) to 8 (worst possible outcome). The lowest possible CAPS score is a 0, indicating no PTSD symptoms reported. The highest possible CAPS score is a 136, indicating the most PTSD symptoms reported.|Pre & post a 12 week treatment group|We limited this arm to 18 subjects who completed 9+ out of 12 treatment sessions.|||CAPS Scores||Standard Deviation|Mean
1402420|NCT01244477|Primary|Continuous Whole Brain Imaging With Standard Imaging Parameters for Each Functional Magnetic Resonance Imaging (fMRI) Scan||Pre & post a 12 week treatment group|||||||
1402421|NCT01244425|Secondary|Median Total Volume of Postoperative Drainage Fluid Within 48 Hours After Surgery||Within 48 hours after surgery|"Full analysis (data) set~Participants who received a drain and for whom the volume for the first 48 hours after surgery is available"|||mL||Full Range|Median
1402422|NCT01244425|Secondary|Percentage of Participants With Transfusion Requirements Until Discharged From Surgical Ward|Transfusions administered included whole blood, packed red blood cells, fresh frozen plasma, and thrombocyte concentrate.|Intra- and postoperative until discharged from surgical ward|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
1402423|NCT01244425|Secondary|Percentage of Participants With Postoperative Rebleeding|Rebleeding until discharged from the surgical ward, defined as any rebleeding from the treated liver resection surface requiring surgical reexploration|Postoperative until discharged from surgical ward|Full analysis (data) set|||Percentage of participants||95% Confidence Interval|Number
1402424|NCT01244425|Secondary|Percentage of Participants With Intraoperative Rebleeding After Occurrence of Hemostasis|Intraoperative rebleeding from the treated liver resection surface after occurrence of hemostasis.|Intraoperative day 0|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
1402447|NCT01243944|Primary|The Percentage of Subjects Achieving a Primary Response at Week 32|Primary response was defined as having achieved hematocrit control (the absence of phlebotomy eligibility beginning at the Week 8 visit and continuing through Week 32) and Spleen Volume Reduction (a greater than or equal to 35% reduction from baseline in spleen volume at Week 32).|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
1402425|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 10 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|10 minutes after start of treatment application|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
1402426|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 8 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|8 minutes after start of treatment application|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
1402427|NCT01244425|Secondary|Percentage of Participants With Intraoperative Hemostasis at 6 Minutes After Application of the Randomized Treatment|Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.|6 minutes after start of treatment application|Full analysis (data) set|||percentage of participants||95% Confidence Interval|Number
1402428|NCT01244425|Primary|Percentage of Participants With Intraoperative Hemostasis at 4 Minutes After Treatment Application|"Hemostasis defined as no visible bleeding on the liver resection surface (liver surgical site) after treatment application. Hemostasis had to be maintained until surgical closure. Time recording started with treatment application, ie, with the start of spraying Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) or with the application of manual compression.~The following were regarded as treatment failures:~No hemostasis achieved at 4 minutes post treatment application (for the FS VH S/D 500 s-apr arm, the “time to hemostasis” was used; a time window of +5 seconds was acceptable for showing a success)~Additional hemostatic treatment (ie, hemostatics in addition to the randomized treatment) was required~Reapplication of FS VH S/D 500 s-apr after 4 minutes~Intraoperative rebleeding after the first 4 minutes of the observation period"|4 minutes post start of treatment application|full analysis (data) set (FAS)|||percentage of participants||95% Confidence Interval|Number
1402429|NCT01244412|Primary|Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera|"Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher.~Scale Image scored as follows~Unacceptable: cannot see fundus detail~Unacceptable: fundus detail visualized, but inadequate for meaningful analysis~Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use~Good: fundus detail visualized, meaningful analysis possible, std photo superior~Excellent: fundus detail visualized as well as std photo~Superior: fundus detail of higher quality than std photo"|estimated 3 months||||participants|||Number
1402430|NCT01244243|Primary|Arm Motor Fugl-Meyer Test|The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.|change from baseline to 1 month post-end treatment, Intention To Treat||||units on a scale||95% Confidence Interval|Mean
1402431|NCT01244243|Primary|Action Research Arm Test|The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.|change from baseline to 1 month post-end treatment, Intention To Treat||||units on a scale||95% Confidence Interval|Mean
1402432|NCT01244126|Secondary|Maximum PAED Score|"Maximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium.~1. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20."|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|The sample size was based on the assumption that the pain scores in the intranasal fentanyl group would be similar to those in previously published data|||units on a scale||Standard Deviation|Mean
1402433|NCT01244126|Primary|Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.|FLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65)|Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge|Analysis was performed on per protocol basis excluding patients with protocol violations|||units on a scale||Standard Deviation|Mean
1402434|NCT01244061|Secondary|7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52|The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the “last 7 days” questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit.|Weeks 12, 24 and 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
1402435|NCT01244061|Secondary|CAR From Week 9 Through Week 24|The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 24|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
1402436|NCT01244061|Secondary|CAR From Week 9 Through Week 52|The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.|Week 9 through Week 52|The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
1402437|NCT01244061|Primary|Continuous Abstinence Rate (CAR) From Week 9 Through Week 12|The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.|Week 9 through Week 12|The Full Analysis Set (FAS) included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug.|||Percentage of participants|||Number
1402438|NCT01243944|Secondary|Estimated Duration of the Complete Hematological Remission|"Duration of the complete hematological remission is defined as the time from the first occurrence of complete hematological remission until the date of the first documented progression (end of response).~Kaplan-Meier estimates are provided for duration of complete hematological remission."|Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.|||probability||95% Confidence Interval|Number
1402439|NCT01243944|Secondary|The Percentage of Subjects Achieving a Durable Complete or Partial Clinicohematologic Response at Week 48|Durable Complete or Partial Clinicohematologic Response was defined as any subject who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants|||Number
1402440|NCT01243944|Secondary|The Percentage of Subjects Who Achieved Overall Clinicohematologic Response at Week 32|Overall Clinicohematologic Response is defined as any subject who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria.|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants|||Number
1402441|NCT01243944|Secondary|Estimated Duration of the Primary Response|"Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response).~Kaplan-Meier estimates are provided for duration of primary response."|Through study completion, analysis was conducted when all patients had completed the Week 80 visit or discontinued the study|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.|||probability||95% Confidence Interval|Number
1402442|NCT01243944|Secondary|The Percentage of Subjects Who Achieved Durable Spleen Volume Reduction at Week 48|Durable Spleen Volume Reduction was defined as a subject who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
1402443|NCT01243944|Secondary|The Percentage of Subjects Who Achieved a Durable Hematocrit Control at Week 48|Durable Hematocrit Control was defined as any subject who achieved phlebotomy eligibility independence from Week 8 to Week 32 and maintained hematocrit control up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
1402444|NCT01243944|Secondary|The Percentage of Subjects Who Achieved a Durable Complete Hematological Remission at Week 48|Durable Complete Hematological Remission was defined as any subject who achieved Complete Hematological Remission at Week 32 and maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
1402445|NCT01243944|Secondary|The Percentage of Subjects Achieving Complete Hematological Remission at Week 32|Complete Hematological Remission at Week 32 was defined as any subject who achieved hematocrit control with a platelet count less than or equal to 400 X 10^9/L and a white blood cell count less than or equal to 10 X 10^9/L.|32 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
1402446|NCT01243944|Secondary|The Percentage of Subjects Achieving a Durable Primary Response at Week 48|Durable Primary Response was defined as any subject who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization.|48 Weeks|Full Analysis Set (FAS) comprises all patients to whom study treatment had been assigned by randomization.|||percentage of participants||95% Confidence Interval|Number
1402448|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy|The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 – height in cm at t12) divided by (date at t24 – date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.|Month 12 to Month 24 (Year 1 to Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.||||||
1402449|NCT01243892|Secondary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment|The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 – height in cm at t0) divided by (date at t12 – date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.|Baseline up to Month 12 (Year 1)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.||||||
1402450|NCT01243892|Primary|Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment|The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (–) height in cm at t0) divided by (date at t24 – date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.|Baseline up to Month 24 (Year 2)|Data for this outcome measure was not collected as the study was terminated prematurely due to slow enrollment.||||||
1402451|NCT01243775|Secondary|Neutropenia Grade 3-4|Toxicity (CECAE ver 4.0) and Safety|2 years||||participants|||Number
1402452|NCT01243775|Secondary|Overall Survival||2 years||||months||95% Confidence Interval|Median
1402453|NCT01243775|Secondary|Progression Free Survival||2 years||||months||95% Confidence Interval|Median
1402454|NCT01243775|Primary|Response Rate|RECIST version 1.1|6th week|Intention to treat population|||participants|||Number
1402455|NCT01243762|Secondary|Number of Participants Whose Best Response is a Partial Response (PR) or Complete Response (CR)|Best response was determined for the maximum tolerated dose from the start of treatment until disease progression, recurrence, or completion of 6 months of treatment. Lesions were measured by computed tomography (CT) scan or magnetic resonance imaging (MRI). Partial response (PR), defined as a tumor burden decrease of 30%, or complete response (CR) was determined using Response Criteria in Solid Tumors (RECIST) 1.1 for participants with at least one measurable target lesion at baseline.|Up to 7 months|All participants who received at least one dose of study therapy and had baseline data for those analyses that required baseline data. The analysis was planned to be performed on the 3 arms in Part 2 only. The study was terminated prior to completion of this analysis.|||Participants|||Number
1402456|NCT01243762|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs were defined as follows: 1) non-hematological toxicity ≥Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 except for Grade 3 nausea, vomiting, diarrhea, and/or dehydration; Grade 3 or 4 hyperglycemia; alopecia; inadequately treated hypersensitivity reactions; dalotuzumab infusion-related reactions; Grade 3 transaminases ≤1 week in duration; or clinically non-significant, treatable or reversible lab abnormalities; 2) Grade 4-5 hematologic toxicity, with the exception of Grade 4 neutropenia <6 days in duration; 3) Grade 3 or Grade 4 neutropenia with fever >38.5 degrees C; 4) Grade 4 thrombocytopenia ≤25.0 x 10^9/Liter; 5) drug-related adverse experience leading to a dose modification during Cycle 1; 6) unresolved drug-related toxicity that causes ≥3 week delay of the next scheduled dose of study medication; 7) persistent increases in QTc interval >60 milliseconds from baseline, or clinically significant bradycardia.|Cycle 1-28 Days|All participants who completed the first cycle of study therapy or discontinued from the study due to a DLT attributable to study therapy.|||Participants|||Number
1402457|NCT01243671|Secondary|Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52|C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.|||mg/dL||Standard Deviation|Mean
1402458|NCT01243671|Secondary|Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52|The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.|||units on a scale||Standard Deviation|Mean
1402459|NCT01243671|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52|Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline, 24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.|||units on a scale||Standard Deviation|Mean
1402466|NCT01243671|Primary|Number of Participants With Marked Improvement at Week 24|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
1402460|NCT01243671|Secondary|Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52|Investigators assessed oral aphthous (mouth ulcers), skin symptoms, eye symptoms and vulval (genital) ulcers during 4 weeks before study visit via participant interview, using the following grades. Oral aphthous: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Skin (Erythema nodosum rash): 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Eye (Uveitis): 0=None; 1=one eye crisis in recent 4 weeks; 2=two eye crises in recent 4 weeks; 3=three eye crises in recent 4 weeks. Vulval (genital) ulcer: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Resolution was defined as: Behçet's disease symptoms other than gastrointestinal symptoms were graded 0 (disappeared).|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.|||participants|||Number
1402461|NCT01243671|Secondary|Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Participants assessed their abdominal pain, diarrhea and other gastrointestinal symptoms (abdominal discomfort, abdominal fullness, etc) during 2 weeks before assessment visit in 5 grades. Investigator confirmed the assessment through interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Improvement of ≥1 grade from baseline is also presented.|24 weeks, 52 weeks|Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.|||participants|||Number
1402462|NCT01243671|Secondary|Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52|Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
1402463|NCT01243671|Secondary|Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52|Study participants completed a global assessment of their gastrointestinal symptoms (Behçet’s disease symptoms other than gastrointestinal symptoms were excluded) during 2 weeks before assessment visit on a 5-grade scale. The investigator confirmed this assessment via interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Global assessment of grade 0 or ≤1 and improvement of ≥1 (from baseline) is presented.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
1402464|NCT01243671|Secondary|Number of Participants With Complete Remission at Week 24 and Week 52|Complete remission was defined as both endoscopic improvement and global assessment of gastrointestinal symptoms grades of 0. Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life.|24 weeks, 52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
1402465|NCT01243671|Secondary|Number of Participants With Marked Improvement at Week 52|Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant’s daily life; 2=symptoms existed in past 2 weeks and slightly affected participant’s daily life; 3=symptoms existed in past 2 weeks and affected participant’s daily life; 4=symptoms existed in past 2 weeks and critically affected participant’s daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).|52 weeks|Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.|||participants|||Number
1402467|NCT01243619|Other Pre-specified|Analyze Correlation Between FDG and FLT PET Scans, and the Correlation Between Both Types of PET Scan and the Response to Treatment.|We will compare the findings of FDG and FLT PET scans at pre-treatment, mid-treatment and post-treatment time points to determine how closely they correlate with each other, and if there is a specific time point at which any observed differences between FDG and FLT PET scans are most pronounced. We will also determine which of the six PET scans may correlate most closely with the response to treatment as determined by pathologic findings at esophagectomy.|1 year|||||||
1402484|NCT01243567|Secondary|Percentage of Patients Reaching a Predefined Target Pressure Threshold|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.|Baseline, Month 3|Intent to Treat: all randomized patients.|||Percentage of Patients|||Number
1402468|NCT01243619|Primary|Feasibility: Determined by the Number of Participants Who Had All Three Sets of Completed Serial PET Scans That Were Imported for Analysis|Determine the possibility of aquiring three sets of serial Positron emission tomography (PET) scans from 5 patients at designated time points and to develop a mechanism to import and analyze images from F-fluoro-3'-deoxy-3'-L-fluorothymidine (FLT)-PET, Fluorodeoxyglucose(FDG)-PET and Computed Tomography (CT) on a single advanced software platform with deformable image registration capability. We will report patient acceptance of and compliance with this regimen, as well as the utility of the software platform for conducting the proposed analysis.|1 year||||participants|||Number
1402469|NCT01243580|Primary|Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3|Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402470|NCT01243580|Primary|Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3|Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3.|3 months|Primary PK population|||ng.h/ml||Standard Deviation|Mean
1402471|NCT01243580|Primary|Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3|Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402472|NCT01243580|Primary|Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402473|NCT01243580|Primary|Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402474|NCT01243580|Primary|Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402475|NCT01243580|Primary|Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402476|NCT01243580|Primary|Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402477|NCT01243580|Primary|Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402478|NCT01243580|Primary|Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.|3 months|Primary PK population|||ng.h/ml||Standard Deviation|Mean
1402479|NCT01243580|Primary|Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3.|3 months|Primary PK population|||ng.h/ml||Standard Deviation|Mean
1402480|NCT01243580|Primary|Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3|Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402481|NCT01243580|Primary|Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1|Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3.|3 months|Primary PK population|||pg/ml||Standard Deviation|Mean
1402482|NCT01243567|Secondary|Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1402483|NCT01243567|Secondary|Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading|IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1402485|NCT01243567|Secondary|Change From Baseline IOP|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1402486|NCT01243567|Primary|Change From Baseline in Average Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).|Baseline, Month 3|Intent to Treat: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1402487|NCT01243450|Primary|Acne Lesion Percent Reduction|Reduction in number of Acne lesions by counting over 12 weeks|12 week||||percent reduction of number of lesions||Standard Deviation|Mean
1402488|NCT01243411|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.|||centimeters||Standard Deviation|Mean
1402489|NCT01243411|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.|||participants|||Number
1402490|NCT01243411|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1402491|NCT01243411|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1402492|NCT01243411|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.|||participants|||Number
1402493|NCT01243411|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
1402494|NCT01243411|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1402495|NCT01243411|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1402496|NCT01243411|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on the modified intent-to-treat (mITT) population.|||percentage of curvature change||Standard Deviation|Mean
1402497|NCT01243320|Primary|Change in Quinone Oxidoreductase 1 Gene|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
1402498|NCT01243320|Primary|Change in Monocyte Chemotactic Protein 1|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
1402499|NCT01243320|Primary|Change to Interleukin-1 Beta Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
1402500|NCT01243320|Primary|Change to Interleukin-1 Alpha Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
1402501|NCT01243320|Primary|Change to Interleukin-8 Receptor|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||ng/mL||95% Confidence Interval|Mean
1402502|NCT01243320|Primary|Sputum Reactive Oxygen Species Change|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||uM||95% Confidence Interval|Mean
1402503|NCT01243320|Primary|Change in Eosinophil Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
1402504|NCT01243320|Primary|Change in Basophils Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
1402505|NCT01243320|Primary|Change In Monocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
1402506|NCT01243320|Primary|Change In Lymphocytes Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||percent||95% Confidence Interval|Mean
1402533|NCT01243294|Secondary|Wear Time (Registered by Subject When Applying and Removing a Product)|Wear time was calculated from the time the subjects applied their product (date, year, time) to the time they detached the product (date, year, time). Wear time was estimated in hours per subject per base plate and mean value was calculated.|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Hours|Participants|Standard Deviation|Mean
1402534|NCT01243294|Secondary|Comfort (Subjects Own Assessment)|"Comfort where evaluated by subjects own assessment on a 5 point scale from very uncomfortable to very comfortable.~Results of participants who answered on own assessment of comfort of wearing the product on a 5 point scale (very uncomfortable, uncomfortable, acceptable, comfortable, very comfortable). Comfortable and very comfortable are the preferred end points and it is these results that are presented here.~Unit of measure is: Percentage of participants answering 'very comfortable' and 'comfortable'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Percent of participants|||Number
1402535|NCT01243294|Secondary|Handling at Appliance (Subjects Own Assessment)|"Handling at appliance where evaluated by subjects own assessment on a 5 point scale from very difficult to very easy.~Results of participants who answered on own feeling of handling at appliance on a 5 point scale (very difficult, difficult, acceptable, easy, very easy). Easy and very easy are the preferred end points and it is the these results that are presented here.~Unit of measure is: Percentage of participants answering 'very easy' and 'easy'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Percent of participants|||Number
1402536|NCT01243294|Secondary|Security (Subjects Own Assessment)|"Results of participants who answered on own assessment of security on a 5 point scale ('very poor', 'poor', 'acceptable', 'good' and 'very good'). 'Good' and 'very good' are the preferred end points The 'very good' result are presented here.~Unit of measure is: Percentage of participants answering 'very good'"|After each test period, i.e. after 10 (±2) days with one test product and after 10 (±2) days with the other test product|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Percent of participants|||Number
1402537|NCT01243294|Secondary|Adverse Events|Safety is evaluated by adverse events occuring continues while the subjects are testing the devices|During the investigation ~ 24 days per subject|"As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device.~Population is ITT"|||Adverse events|||Number
1402538|NCT01243294|Primary|Leakage (Percent of All Base Plates With Leakage)|Leakage is evaluated after each change of base plate on a 4-point scale from no leakage, leakage on the base plate, leakage soiling clothe and sudden leakage - the 3 last mentioned are all defined as leakage. No leakage is the preferred end point|After each base plate change measured over a period of 10 +/- 2 days. Base plates are changed 1-6 times a day|Intention to treat. As this is a cross-over investigation 26 started at SS and crossed over to SenSura, and 28 started at SenSura and crossed to SS leading to a total population of 54 evaluating each medical device|||Percent of Base plates|Participants||Number
1402539|NCT01243242|Secondary|Clinical Global Impression Scale (CGI-I)Score|"The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-I scores range from 1 (‘very much improved’) through to 7 (‘very much worse’).~During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."|6 weeks from visit 1 baseline to visit 6|"The ITT population included all randomized subjects who completed at least one post-randomization visit.~During the conduct of the study, CGI-I evaluations were not done correctly and thus data interpretation is limited."|||units on a scale||Standard Deviation|Mean
1402540|NCT01243242|Secondary|Adult ADHD Quality of Life (AAQoL)- Measuring Change in Total Score of AAQoL From Visit 1 to Visit 6|The AAQoL scale provides a validated disease-specific measure of the impact of ADHD on quality of life.It is scored as an overall score (29 items) and four subscale scores: life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Individual items are scored on a five-point Likert-like scale from ‘Not at all/Never’ (1) to ‘Extremely/Very Often’ (5).|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit|||units on a scale||Standard Deviation|Mean
1402541|NCT01243242|Secondary|Test of Variables of Attention (TOVA) (Change in ADHD Score From Screening to Visit 6)|The TOVA is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning. ADHD score is a comparison of the subject's response to the CPT test to those of an ADHD group, and is reported as a Z-score. An ADHD score of -1.80 and less fits the profile of the ADHD sample. A score of more than -1.80 (more positive) does not fit the ADHD profile. When comparing ADHD scores the higher the ADHD score the better the performance.|6 weeks( visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.|||Z score||Standard Deviation|Mean
1402542|NCT01243242|Primary|Conners’ Adult ADHD Rating Scales (CAARS™)|The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 (‘Not at all’, ‘never’) to 3 (‘Very much’, ‘very frequently’). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90|6 weeks (from visit 1 baseline to visit 6)|The ITT population included all randomized subjects who completed at least one post-randomization visit.|||units on a scale||Standard Deviation|Mean
1402543|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)|"An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose."|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.|||Participants|||Number
1402544|NCT01243177|Secondary|Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.|12 consecutive months of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.|||percentage of subjects||95% Confidence Interval|Number
1402545|NCT01243177|Primary|Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.|||Participants|||Number
1402546|NCT01243177|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.|Duration of the Treatment Phase (up to 113 weeks)|Safety Analysis Set consisting of all randomized subjects who took at least 1 dose of study medication.|||Participants|||Number
1402547|NCT01243177|Primary|Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment|The Per Protocol Set (PPS) was defined as containing all subjects in the Full Analysis Set (FAS) who did not have any important protocol deviations determined to impact the interpretation of primary efficacy.|||percentage of subjects||95% Confidence Interval|Number
1402548|NCT01243177|Primary|Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject|The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.|6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject|Full Analysis Set (FAS), consisting of all randomized subjects who took at least 1 dose of study medication.|||percentage of subjects||95% Confidence Interval|Number
1402549|NCT01243112|Primary|Onset of Action|Time from infusion of local anesthetic to loss of sensation to sharp.|Up to 5 minutes||||second||Standard Deviation|Mean
1402550|NCT01243112|Primary|Length of Action|The time from onset of local anesthesia until cessation of effect by sensation of sharp measured in 15 minute increments.|Up to 12 hours|A calculation was made to power the study appropriately to determine a difference of 5 minutes based on previous studies which did not include the use of epinephrine.|||minutes||Standard Deviation|Mean
1402551|NCT01242813|Secondary|Number of Participants With Anti-canakinumab Antibodies at Any Visit|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.|||Number of participants|||Number
1402552|NCT01242813|Secondary|Serum Concentration of Total Interleukin-1β Antibody (IL-1β)|Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL).|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||pg/mL||Standard Deviation|Mean
1402553|NCT01242813|Secondary|Serum Concentration of Canakinumab|Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug.|Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||microgram(s)/milliliter||Standard Deviation|Mean
1402554|NCT01242813|Secondary|Percentage of Participants Who Relapsed and Received Rescue Medication|Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication.|Day 85 to Day 953 (End of treatment period to End of study)|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
1402555|NCT01242813|Secondary|Time to Relapse After Last Dose of Canakinumab|Relapse was defined as a Physician’s Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 85 to Day 253 (End of treatment period to Follow-up period)|The analysis was performed on the FAS population.|||Days||95% Confidence Interval|Median
1402556|NCT01242813|Secondary|Percentage of Relapsed Participants|Relapse was defined as a Physician’s Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15.|Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
1402557|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Participant's Global Assessment Score|Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 253 (End of follow-up period)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1402558|NCT01242813|Secondary|Percentage of Participants With Defined Grades in Physician’s Global Assessment Score|Participants were assessed based by physician on Physician’s Global Assessment measured on a 5-point scale for TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 1 up to Day 953 (End of study)|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
1402559|NCT01242813|Secondary|Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain|TRAPS signs and symptoms were assessed in 4 key categories: skin disease (skin rash), eye manifestations, extremity pain (musculoskeletal), and abdominal pain. Participants were assessed for TRAPS associated signs and symptoms a 5-point Physician’s global assessment scale: None/absent (no); 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 113 (end of treatment period) up to Day 925 (End of study)|The analysis was performed on the FAS population.|||Percentage of participants|||Number
1402560|NCT01242813|Secondary|Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. Negative percent change in concentration of inflammatory markers indicated improvement.|Day 1 up to Day 953 (End of study)|The analysis was performed on the FAS population.|||Percent change||Full Range|Median
1402561|NCT01242813|Secondary|Time to Participant's Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a participant's Global Assessment of TRAPS symptoms of scale 1 or less. The participant's Global Assessment was based on a 5-point scale: 0 = None/absent (no) ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.|||Days||95% Confidence Interval|Median
1402562|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8|Participants who had not achieved a complete response at Day 8 were given an additional dose of canakinumab. Complete response was defined as clinical remission (Physician’s Global Assessment of TRAPS activity absent or minimal) and serological remission (CRP and/or SAA < 10 mg/L). Almost complete response was defined as clinical remission and a partial serological remission (≥ 70% reduction of baseline CRP and/or SAA).|Day 15|"The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
1402563|NCT01242813|Secondary|Time to Physician’s Assessed Clinical Remission|Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a Physician’s Global Assessment of TRAPS symptoms of scale 1 or less. The physician's Global Assessment was based on a 5-point scale: 0 = None/absent ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline up to Day 15|The analysis was performed on the FAS population.|||Days||95% Confidence Interval|Median
1402564|NCT01242813|Secondary|Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15|The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L.|Day 8 and Day 15|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
1402565|NCT01242813|Secondary|Percentage of Participants With Complete Clinical Remission at Day 8 and 15|Complete clinical remission was defined as Physician’s Global Assessment of TRAPS activity to be absent or minimal (1). TRAPS associated clinical signs and symptoms were assessed by the investigator at every visit on a 5-point scale: 0 = Absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe.|Day 8 and Day 15|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
1402566|NCT01242813|Secondary|Percentage of Participants With Complete or Almost Complete Response at Day 8|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician’s Global Assessment of TRAPS activity absent or minimal and serological remission was defined as CRP and/or SAA < 10 mg/L. Almost complete response was defined as clinical remission and a partial serological remission (≥70% reduction of baseline CRP and/or SAA).|Day 8|The analysis was performed on the FAS population.|||Percentage of participants||95% Confidence Interval|Number
1402617|NCT01241591|Secondary|Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 12|FAS; OC|||mm||Standard Error|Mean
1402567|NCT01242813|Primary|Percentage of Participants With Complete or Almost Complete Response at Day 15|Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician’s Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than [≥] 70% reduction of baseline CRP and/or SAA).|Day 15|The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy.|||Percentage of participants||95% Confidence Interval|Number
1402568|NCT01242748|Secondary|Serum Levels of Prostate-specific Antigen (PSA) During 3 Years’ Treatment With Degarelix or Goserelin|Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||ng/mL||Full Range|Median
1402569|NCT01242748|Secondary|Serum Levels of Testosterone During 3 Years’ Treatment With Degarelix or Goserelin|Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.|Baseline and after 1, 6, 12, 19, and 22 months|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||ng/mL||Full Range|Median
1402570|NCT01242748|Secondary|Hazard Ratio of Mortality Rates During 3 Years’ Treatment Between Degarelix and Goserelin|The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of deaths||95% Confidence Interval|Number
1402571|NCT01242748|Secondary|Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years’ Treatment Between Degarelix and Goserelin|Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no additional therapy||95% Confidence Interval|Number
1402572|NCT01242748|Secondary|Hazard Ratio of Testosterone Escape Rates During 3 Years’ Treatment Between Degarelix and Goserelin|Testosterone escape is defined as serum levels >0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no testosterone escape||95% Confidence Interval|Number
1402573|NCT01242748|Secondary|Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no PSA failure||95% Confidence Interval|Number
1402574|NCT01242748|Secondary|Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin|PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no PFS failure||95% Confidence Interval|Number
1402575|NCT01242748|Primary|Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years’ Treatment Between Degarelix and Goserelin|PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.|From baseline to 3 years|CS35 (NCT00946920)/CS35A Full Analysis Set (degarelix n=565; goserelin n=282). The analysis population was pre-specified in the study protocol and statistical analysis plan.|||percentage of no PSA-PFS||95% Confidence Interval|Number
1402576|NCT01242527|Primary|Fasting Serum Triglycerides|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in triglycerides between placebo and the 2g/day, 3g/day and 4g/day Epanova groups|12 weeks|The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented.|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
1402577|NCT01242514|Secondary|Mean HAQ-DI Score|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Units on a scale||Standard Deviation|Mean
1402578|NCT01242514|Secondary|Mean mTSS Score|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily|Weeks 0 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Units on a scale||Standard Deviation|Mean
1402579|NCT01242514|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study (variable duration; maximum 109 weeks)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Percentage of patients|||Number
1402580|NCT01242514|Secondary|Mean DAS28-CRP Score|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily|Weeks 0, 12, 24, 36 and 52|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||Units on a scale||Standard Deviation|Mean
1402581|NCT01242371|Secondary|Measurement of Gliadin and Casein Antibody Levels||16 weeks (baseline prior to placebo run in to week 14)|||||||
1402582|NCT01242371|Secondary|Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14|"Self report rating of difficulty moving bowels on a 4 point scale from no difficulty to severe difficulty"|14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)|||||||
1402583|NCT01242371|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.|14 weeks (week 0 to week 14)|Week 0 data is based on the number of participants in the probiotic supplement group (n=33) and the placebo group (n=32) who began the treatment phase. Week 14 data is based on the number of participants in the probiotics supplement group (n=31) and the placebo group (n=27) who completed the treatment phase.|||units on a scale||Standard Deviation|Mean
1402584|NCT01242176|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Standard Deviation|Mean
1402585|NCT01242176|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~Note the standard deviation is actually the CV (%)."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Standard Deviation|Mean
1402586|NCT01242176|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the coefficient of variation (CV (%))."|30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Standard Deviation|Mean
1402587|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test FVC During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Forced Vital Capacity.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage change||Standard Deviation|Mean
1402588|NCT01242111|Secondary|Percent Change From Baseline in Respiratory Function Test MVV During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage change||Standard Deviation|Mean
1402589|NCT01242111|Secondary|Percent Change From Baseline in Urine Keratan Sulfate (uKS) Levels During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 168 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage change||Standard Deviation|Mean
1402590|NCT01242111|Secondary|Change in Baseline in Endurance as Measured by the 3 Minute Stair Climb During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in the 3-minute Stair Climb Test (3MSCT). Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.|||steps/min||Standard Deviation|Mean
1402591|NCT01242111|Secondary|Change From Baseline in Endurance as Measured by the 6-minute Walk Test During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline and every 12 weeks for up to 72 weeks during the MOR-002 pilot trial and every 24 weeks for up to 192 weeks during the MOR-100 extension trial|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.|||meters||Standard Deviation|Mean
1402592|NCT01242111|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).~The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 240 weeks|The primary outcome measure data is presented in more detail under the Adverse Events section.|||participants|||Number
1402593|NCT01242085|Primary|Alignment of Knee - Measured Mechanical Axis From CT Data|the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment|postoperatively - CT done within 1 week of surgery|all participants who completed the study|||degrees||95% Confidence Interval|Mean
1402594|NCT01242085|Secondary|Surgical Time|the difference between the average surgical time will be determined and compared with 95% CI|intraoperative surgical time|particpants who completed study|||delta between means in minutes||95% Confidence Interval|Mean
1402595|NCT01242020|Secondary|Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues||up to 30 days|Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal muscle microvascular flow were not be collected for this outcome measure.||||||
1402596|NCT01242020|Primary|Variability of Repeated Measures for Each Subject|The variability of repeated measures for each subject, expressed as coefficient of variation (CV), in the periadventitial microvascular flow, subcutaneous microvascular flow and skeletal muscle flow.|up to 30 days|Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal microvascular flow were not collected for the Outcome Measure.||||||
1402597|NCT01241916|Secondary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.|12 months||||units on a scale||Full Range|Mean
1402598|NCT01241916|Primary|Change in Arc of Flexion and Extension|Active ulnohumeral motion will be measured using a hand-held goniometer by the co-investigator not involved in the care of the patient at enrollment and 6 months after enrollment.|baseline and 6 months||||Degrees||Full Range|Mean
1402599|NCT01241903|Secondary|Biomarkers of Platelet Function and Myocardial Necrosis||up to 30 days|||||||
1402600|NCT01241903|Primary|Platelet - Leukocyte Aggregates|measured by flow cytometry|within first 24 hours||||% leukocytes with platelets attached||Standard Error|Mean
1402601|NCT01241760|Secondary|Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)|The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.|End of trial, 12 weeks after the last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
1402602|NCT01241760|Secondary|Percentage of Participants Who Relapsed During Follow-up Period|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug)|The analysis was performed on subjects with HCV RNA <25 IU/mL at the planned end of treatment, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.|||percentage of participants|||Number
1402603|NCT01241760|Secondary|Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs|The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.|Week 4, 12, 24, 32, 40|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants|||Number
1402604|NCT01241760|Secondary|Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.|Baseline, Week 4 and Week 4+12.|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
1402687|NCT01241461|Secondary|Number of Participants With Tumor Response|Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is ≥30% decrease in sum of longest diameter of target lesions.|Baseline to study completion up to Day 183|All participants who were enrolled in the study.|||Participants|||Count of Participants
1402605|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)|The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).|End of trial, 72 weeks after the start of study medication|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
1402606|NCT01241760|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)|The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.|End of trial, 24 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
1402607|NCT01241760|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)|The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).|End of trial, 12 weeks after last planned dose|All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.|||percentage of participants with response|||Number
1402608|NCT01241591|Secondary|Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Week 12|FAS; OC|||scores on a scale||Standard Error|Mean
1402609|NCT01241591|Secondary|Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment|The PQOL-12 is a 12-item questionnaire; 8 of the items on the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) focus on emotional issues associated with psoriasis (self conscious, helpless, embarrassed, ability to enjoy life). The last 4 items deal with physical symptoms (pain or soreness, itch, physical irritation) and choice of clothing. The recall period is over the past month. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst. Scores from each question are summed to give a total score (range 0 -120); higher scores indicate greater impairment to quality of life.|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
1402610|NCT01241591|Secondary|Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work.|Week 12|FAS; OC|||percentage of participants|||Number
1402611|NCT01241591|Secondary|Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work|Psoriasis Health Care Resource Utilization Questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The questionnaire assesses employment status of participant (employed: yes or no) and if currently employed it asks the participant if they were absent or on sick leave from work due to psoriasis; if unemployed it asks the participant if the unemployment is due to psoriasis.|Baseline and Week 12|FAS; OC|||percentage of participants|||Number
1402612|NCT01241591|Secondary|Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment||Week 12|FAS; OC|||percentage of participants|||Number
1402613|NCT01241591|Secondary|Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment|The Psoriasis Health Care Resource Utilization (Ps-HCRU) questionnaire is a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. The first section assesses direct costs associated with healthcare resource use (interactions with healthcare providers such as general practitioners [GPs], primary care physicians [PCPs], or family medicine physicians [FMP], emergency room visits, and hospitalizations), and the second section assesses indirect costs associated with absenteeism due to psoriasis and the impact of psoriasis on productivity at work.|Baseline (BL) and Week 12|FAS; OC|||percentage of participants|||Number
1402614|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Week 12|FAS; OC|||scores on a scale||Standard Error|Mean
1402615|NCT01241591|Secondary|Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 12|FAS; OC|||Units on a scale||Standard Error|Mean
1402616|NCT01241591|Secondary|Mean Change From Baseline in EQ-5D VAS at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Week 12|FAS; OC|||mm||Standard Error|Mean
1402618|NCT01241591|Secondary|Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Week 12|FAS; OC|||scores on a scale||Standard Error|Least Squares Mean
1402619|NCT01241591|Secondary|Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
1402620|NCT01241591|Secondary|Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12|The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from “very dissatisfied” to “very satisfied” with the study medication.|Week 12|FAS; OC|||percentage of participants|||Number
1402621|NCT01241591|Secondary|Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment|The PSSM is a single, 7 point item that evaluates overall participant satisfaction with the study treatment. Response options range from “very dissatisfied” to “very satisfied” with the study medication.|Week 12|FAS; OC|||percentage of participants|||Number
1402622|NCT01241591|Secondary|Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe). Response defined as score of 0 or 1.|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
1402623|NCT01241591|Secondary|Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline and Weeks 2, 4, and 8|FAS; OC|||percentage of participants|||Number
1402624|NCT01241591|Secondary|Mean Change From Baseline in SF-36 Domain Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Week 12|FAS; OC|||score on a scale||Standard Error|Mean
1402625|NCT01241591|Secondary|Mean Change From Baseline in SF-36 MCS and PCS Scores|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Week 12|FAS; OC|||score on a scale||Standard Error|Mean
1402626|NCT01241591|Secondary|Mean SF-36 Domain Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
1402627|NCT01241591|Secondary|Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Higher scores indicate a better health related quality of life.|Baseline and Week 12|FAS; OC|||score on a scale||Standard Error|Mean
1402628|NCT01241591|Secondary|Median Time to DLQI Response|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. DLQI Response was defined as a 5-point reduction in the total DLQI score.|Weeks 4 and 12|Data were not analyzed as the endpoint of proportion of participants achieving a 5-point reduction from baseline in DLQI provided similar information.||||||
1402629|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC|||percentage of participants|||Number
1402630|NCT01241591|Secondary|Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Weeks 4 and 12|FAS; OC|||percentage of participants|||Number
1402631|NCT01241591|Secondary|Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC|||scores on a scale||Standard Error|Mean
1402632|NCT01241591|Secondary|Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4 and 12|FAS; OC|||score on a scale||Standard Error|Mean
1402633|NCT01241591|Secondary|Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4 and 12|FAS; OC|||score on a scale||Standard Error|Mean
1402634|NCT01241591|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4 and 12|FAS; OC|||score on a scale||Standard Error|Mean
1402635|NCT01241591|Secondary|Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
1402636|NCT01241591|Secondary|Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
1402637|NCT01241591|Secondary|Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment|ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline, Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
1402638|NCT01241591|Secondary|Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment||Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
1402639|NCT01241591|Secondary|Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC|||weeks||95% Confidence Interval|Median
1402640|NCT01241591|Secondary|Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
1402641|NCT01241591|Secondary|Median Time to PASI50 Response During the 12-Week Double-Blind Treatment||Baseline up to Week 12|FAS; OC|||weeks||95% Confidence Interval|Median
1402642|NCT01241591|Secondary|Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participatns|||Number
1402643|NCT01241591|Secondary|Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant(fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||percent change from baseline||Standard Error|Mean
1402644|NCT01241591|Secondary|Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The % surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||percent psoriatic BSA||Standard Error|Mean
1402645|NCT01241591|Secondary|Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||scores on a scale||Standard Error|Mean
1402646|NCT01241591|Secondary|Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
1402647|NCT01241591|Secondary|Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Weeks 2, 4, 8, and 12|FAS; OC|||scores on a scale||Standard Error|Mean
1402648|NCT01241591|Secondary|Mean PASI Score During the 12-Week Double-Blind Treatment|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||score on a scale||Standard Error|Mean
1402649|NCT01241591|Secondary|Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to baseline/Day 1.|Weeks 2, 4, and 8|FAS; OC|||percentage of participants|||Number
1402650|NCT01241591|Secondary|Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 2, 4, 8, and 12|FAS; OC|||percentage of participants|||Number
1402651|NCT01241591|Secondary|"Percentage of Participants With a PGA Response of Clear or Almost Clear During the 12-Week Double-Blind Treatment"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response is defined as 0 (clear) or 1 (almost clear).|Weeks 2, 4, and 8|FAS; Observed Case (OC): no imputation|||percentage of participants|||Number
1404216|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Threshold|RA pacing threshold results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge|||volts (V)||Standard Deviation|Mean
1402652|NCT01241591|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.|Week 12|FAS; NRI|||percentage of participants|||Number
1402653|NCT01241591|Primary|"Percentage of Participants With a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 12|Full Analysis Set (FAS): all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (CP-690,550, etanercept, or placebo); Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.|||percentage of participants|||Number
1402654|NCT01241565|Secondary|Incidence of Serosal Tearing||Day 30||||participants||95% Confidence Interval|Number
1402655|NCT01241565|Secondary|Duration of Chest Tube Following Surgery|Chest tube duration was calculated as removal date – placement date + 1|Approximately Day 5||||days||Standard Deviation|Mean
1402656|NCT01241565|Secondary|Length of Hospital Stay||Approximately Day 6||||days||Standard Deviation|Mean
1402657|NCT01241565|Secondary|Duration of Air Leak|Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.|Day 30||||days||Standard Deviation|Mean
1402658|NCT01241565|Secondary|Incidence of Air Leaks|As recorded on the air leak log.|Day 30||||number of patients with air leaks|||Number
1402659|NCT01241565|Primary|Incidence of Prolonged Air Leaks|Defined as > 5 days by the Society for Thoracic Surgery|Day 30||||participants|||Number
1402660|NCT01241552|Secondary|Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|Up to 12 weeks|Participants with compromised immunity at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402661|NCT01241552|Secondary|Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with an epidemic strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402662|NCT01241552|Secondary|Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with the B1/NAP1/027 strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402663|NCT01241552|Secondary|Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2)body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|Up to 12 weeks|Participants with clinically severe CDI at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402664|NCT01241552|Secondary|Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants with a history of CDI in the 6 months prior to enrollment who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402665|NCT01241552|Secondary|Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.|Up to 12 weeks|Participants ≥ 65 years of age at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402666|NCT01241552|Primary|Percentage of Participants With Infusion-specific AEs|Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.|Up to 24 hours|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
1402667|NCT01241552|Primary|Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
1402668|NCT01241552|Primary|Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor’s product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
1402669|NCT01241552|Primary|Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion|A SAE is any AE occurring at any dose or during any use of Sponsor’s product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
1402670|NCT01241552|Primary|Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
1402671|NCT01241552|Primary|Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE.|Up to 28 days|All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.|||Percentage of participants|||Number
1402688|NCT01241461|Primary|Number of Participants With Clinically Significant Effects|A clinically significant effect was any event that was a dose-limiting toxicity event (DLT). DLT was defined as an adverse event related to LY2584702 during Cycle 1 (Day 1 to Day 30) that fulfills any one of the following criteria; Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 non-hematological toxicity; platelet count <50.0 x 10^9/Liter (L) with bleeding; CTCAE Grade 4 platelet count decreased; neutrophil count <0.5 x 10^9/L lasting for 5 days or longer; any febrile neutropenia; CTCAE Grade 4 anemia; participant risk due to increasing toxicity.|Baseline through 30 days|All participants who were enrolled in the study.|||Participants|||Count of Participants
1402672|NCT01241552|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; complied with Good Clinical Practice; and achieved clinical cure of the initial CDI episode.|||Percentage of participants|||Number
1402673|NCT01241552|Secondary|Percentage of Participants With Global Cure|Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402674|NCT01241552|Primary|Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode|Up to 12 weeks|Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.|||Percentage of participants|||Number
1402675|NCT01241539|Secondary|Additional Safety Parameters|By study design abnormalities could be due to dialysis or Dabigatran.|2 periods of 5 days each|TS|||Participants|||Number
1402676|NCT01241539|Secondary|Safety and Tolerability|Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.|2 periods of 5 days each|TS|||Participants|||Number
1402677|NCT01241539|Secondary|Coagulation Parameters|Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.|Day 3|TS|||sec||Standard Deviation|Mean
1402678|NCT01241539|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.|Day 3|PKS|||h||Geometric Coefficient of Variation|Geometric Mean
1402679|NCT01241539|Secondary|Maximum Plasma Concentrations of Dabigatran (Cmax)|Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.|Days 2 and 3|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1402680|NCT01241539|Secondary|Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)|Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.|Days 2 and 3|Pharmacokinetic set (PKS) includes all evaluable patients of the TS who received at least 1 dose of dabigatran etexilate, who provided at least 1 observation for at least 1 Pharmacokinetics (PK) endpoint, and who did not have important protocol violations relevant to the evaluation of PK|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1402681|NCT01241539|Primary|Plasma Concentration Extraction Ratio|Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).|4 hours|PKS|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1402682|NCT01241539|Primary|Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis|Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.|4 hours|PKS|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1402683|NCT01241539|Primary|Dialysis Clearance of Dabigatran|Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.|4 hours|Pharmacokinetic set (PKS) includes all evaluable patients of the treated set who received at least one dose of dabigatran etexilate and who provide at least one observation for at least one Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1402684|NCT01241513|Primary|Arterial Oxygen Saturation|Finger Pulse Oximetry to measure arterial oxygen saturation|Day 4 of treatment during acute altitude exposure||||percentage of oxygen saturation||Standard Deviation|Mean
1402685|NCT01241461|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2584702||Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose|All participants who were enrolled in the study.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1402686|NCT01241461|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2584702|AUC of single dose is AUC(0-12hours), and AUC of multiple doses is AUC during one dosing interval at steady state.|Cycle 1 Day 1: Predose, 0.5,1,2,3,5,8,12 hours; Cycle 1 Day 2:24 and 36 hours; Cycle 1 Day 3: Predose sample (before first dose on day 3); Cycle 1 Day 10: Predose,0.5,1,2,3,5,8,12 hours;Cycle 1 Day 17: Predose;Cycle 1 Day24: Predose;Cycle 2 Day 1: Predose|All participants who were enrolled in the study.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1402689|NCT01241448|Secondary|The 30-Day Adjusted Rate of Hypoglycemic Episodes|A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) [3.9 millimoles per liter (mmol/L)]. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Outcome measure was not analyzed due to the limited number of hypoglycemic events observed.|Baseline through 24 weeks|Outcome measure was not analyzed due to the limited number of hypoglycemic events observed; therefore zero participants were analyzed.||||||
1402690|NCT01241448|Secondary|The Percentage of Participants Experiencing a Hypoglycemic Episode|A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) [3.9 millimoles per liter (mmol/L)].|Baseline through 24 weeks|All randomized participants who received at least 1 dose of study drug (excluding participant data from the excluded site).|||percentage of participants|||Number
1402691|NCT01241448|Secondary|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021|Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Baseline up to 26 weeks|All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1402692|NCT01241448|Secondary|Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021|Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Baseline up to 26 weeks|All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1402693|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Weight|Least squares means were adjusted for baseline weight, metformin use, visit, treatment and visit by treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline weight measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
1402694|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B|HOMA-B is a computer model (based on HOMA-2) that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Higher values indicate greater beta cell function. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 week|All randomized patients with at least 1 post-baseline HOMA-B measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||percent of normal reference population||95% Confidence Interval|Least Squares Mean
1402695|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is a computer model (based on HOMA2) which uses fasting plasma insulin and glucose concentrations to estimate insulin resistance (HOMA-IR) as a proportion reference population (normal young adults). The normal reference population with normal function was indexed to 1.0. Higher values indicate increased insulin resistance. Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline HOMA-IR measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||proportion of normal reference populatio||95% Confidence Interval|Least Squares Mean
1402696|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Free Fatty Acids|Least squares mean use an analysis of covariance model. The model included baseline free fatty acid, metformin use and treatment.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline free fatty acid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
1402697|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)|Subfraction included: Very Low Density Lipoprotein (VLDL) Total. Least squares mean use an analysis of covariance model. The model included baseline lipoprotein subfractions, metformin use and treatment.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline lipoprotein subfractions measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized, last observation carried forward (LOCF) principle was applied.|||nanomoles per liter (nmol/L)||Standard Error|Least Squares Mean
1402698|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile|Fasting Lipid Profile included: Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline fasting lipid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1402836|NCT01240330|Primary|Change in Femoral Venous Peak Flow Velocity Compared to Resting Baseline|The femoral vein in the mid-thigh area was located and the femoral venous Peak Flow Velocity (PFV)was measured using duplex ultrasound during the compression phase of treatment. PFV is the maximum velocity of blood flow achieved when the foot and calf compression is applied. The PFV was then compared to the subject's own baseline PFV using a paired t-test.|3 measurements/10 min. therapy||||cm/s||95% Confidence Interval|Mean
1402699|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total|GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. Total GLP-1 is the active GLP-1 and the Dipeptidyl Peptidase IV cleaved GLP-1 form. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline GLP-1 active and total measurements (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||picomoles per liter (pmol/L)||95% Confidence Interval|Least Squares Mean
1402700|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Insulin|Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline fasting insulin measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||picomoles per liter (pmol/L)||95% Confidence Interval|Least Squares Mean
1402701|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Plasma Glucose|Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline plasma glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1402702|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile|SMBG profiles consisted of blood glucose values collected before and 2 hours after the 3 main meals and at 0300 hours (3:00 AM). Values represent mean of values collected same time on 3 separate days within a week prior to visit. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All randomized patients with at least 1 post-baseline self-monitored glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
1402703|NCT01241448|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)|Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All participants randomly assigned to treatment with at least 1 post-baseline laboratory FBG measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomly assigned.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1402704|NCT01241448|Primary|Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)|Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.|Baseline, 24 weeks|All participants randomly assigned to treatment with at least 1 post-baseline HbA1c measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the participants were randomly assigned.|||percentage of Hemoglobin A1c (HbA1c)||90% Confidence Interval|Least Squares Mean
1402705|NCT01241292|Secondary|Number of Participants Positive for Anti-Elotuzumab Anti-drug Antibodies - Treated Participants|The detection of anti-elotuzumab anti-drug antibodies (ADAs) in human serum was performed using a validated bridging electrochemiluminescence immunoassay (ECLA) on the Meso Scale Discovery (MSD) platform. Sample collection was performed prior to administration of elotuzumab at Day 1 of each cycle.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
1402706|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1 - Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
1402707|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
1402717|NCT01241240|Secondary|Change From Baseline in Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each visit. A negative change from Baseline indicated improvement.|Baseline, Weeks 1, 2, 4 and 8|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
1402708|NCT01241292|Primary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes (absolute) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils (absolute): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
1402709|NCT01241292|Secondary|Geometric Mean Minimum Observed Serum Elotuzumab Concentration (Cmin) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmin was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate PK concentration profiles were summarized.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1402710|NCT01241292|Secondary|Geometric Mean Maximum Observed Serum Elotuzumab Concentration (Cmax) During Cycles 1, 2, and 3|The quantification of elotuzumab in human serum was performed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (µg/mL). Samples of serum were obtained at: Cycle 1, Day 1: 0 hour (h), 30 minutes (min) 2 h post dose; Day 8: 0h, 2 h; Day 15: 0h, 30 min; Day 22: 0h, 30min, 2h. Cycle 2, Day 1, 22 0h, 2h. Cycle 3, Day 1: 0h, 30h, 2h; Day 15: 0h.|Days 1, 8, 15 and 22 of cycle 1, Days 1 and 22 of cycle 2, Days 1 and 15 of cycle 3|All participants who received at least one dose of study medication and had adequate Pharmacokinetic (PK) concentration profiles were summarized.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1402711|NCT01241292|Secondary|Number of Participants With Best Overall Response - Treated Participants|Complete response (CR) and Partial Response (PR) were based on the European Group for Blood and Bone Marrow Transplant (EBMT) Criteria. Very Good Partial response was derived from the International Myeloma Working Group (IMWG) criteria. Participants who had a reduction in M-protein or plasmacytoma but did not meet the EBMT criteria for PR were classified as minimal response (MR). Hematologic, radiologic and/or clinical assessments were done every cycle starting with cycle 2. Each cycle is 4 weeks in length (Day 1, Day 8, Day 15, Day 22). Cycle 2 began on study Day 29. CR=negative immunofixation 6 weeks, <5% plasma cells, no increase in size or number of lytic lesions, complete disappearance of extramedullary plasmacytoma. PR=≥50%reduction in M-protein for 6 weeks, ≥90% reduction of urinary light chain excretion or < 200 mg/24hours for 6 weeks, ≥50% reduction in size of extramedullary plasmacytoma present at baseline, no increase in size or number of lytic lesions.|Cycle 2 (Study Day 29) to last dose (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized (Treated Participants).|||participants|||Number
1402712|NCT01241292|Primary|Number of Participants With Clinically Relevant Vital Sign Findings|Vital signs (body temperature, seated blood pressure, heart rate, and respiration rate) were recorded at screening on Days 1, 8, 15, and 22 of Cycles 1 and 2, on Days 1 and 15 of Cycle 3, and at the end of treatment. Blood pressure (Diastolic and Systolic) and heart rate were recorded after the participant sat quietly for at least 5 minutes. Clinical relevance of vital sign data was determined by the investigator.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized.|||participants|||Number
1402713|NCT01241292|Primary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Data cut-off February 2014.|First dose (Day 1) to last dose plus 60 days (assessed up to January 2017, approximately 71 months)|All participants who received at least one dose of study medication were summarized (Treated Participants).|||participants|||Number
1402714|NCT01241279|Secondary|Visual Acuity|Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.|All visits through visit 4 (day 160-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.||||||
1402715|NCT01241279|Primary|Amplitude of Accommodation|The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.|Visit 4 (postoperative day 120-180)|DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.||||||
1402716|NCT01241240|Secondary|Mean Worse Eye IOP|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at each time-point.|Weeks 1, 2, 4, 8 and 12|Participants from the mITT population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
1402796|NCT01240785|Secondary|Gestational Weeks at Delivery Per Arm||delivery||||weeks||Standard Deviation|Mean
1402797|NCT01240785|Secondary|Mode of Delivery Per Arm||delivery||||no of cesarean section|||Number
1402798|NCT01240785|Secondary|Pre-eclampsia Per Arm||up to on the average 40 weeks of gestation||||participants|||Number
1402718|NCT01241240|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. For each eye, the IOP was either the average of 2 measurements, or, if a third measurement was required, the median of the 3 measurements. The worse eye was determined based on the IOP results at Baseline. The mean worse eye IOP was the average of the IOP measurements of the worse eye at hours 0 and 2 at week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the modified Intent-to-treat (mITT) population, that included all randomized participants who had at least 1 post-baseline IOP measurement, with data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
1402719|NCT01240915|Secondary|Change From Baseline in Patient-Reported Rectal Bleeding up to Week 16|Patient-reported diary data assessed the number of bowel movements (BM) per day when not having a flare and the presence of blood in the stools (rectal bleeding [RB]), if any.|Baseline and Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
1402720|NCT01240915|Secondary|Change From Baseline in Biopsy Histology Scores at Week 8|A 15 to 25 centimeter (cm) biopsy sample of inflamed mucosal tissue was taken from the worst affected area and scored using the Riley Index. The Riley Index is a histologic scoring system for the assessment of the activity and severity of ulcerative colitis, ranging from 0 to 24. It consists of 6 histologic features (acute inflammatory cell infiltrate, crypt abscesses, mucin depletion, surface epithelial integrity, chronic inflammatory cell infiltrate, and crypt architectural irregularities), all scored on a 4-point scale (higher scores indicate more severe disease).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
1402721|NCT01240915|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 4, 8, 12, and 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo Score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Higher scores indicate more severe disease.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
1402722|NCT01240915|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis, with total score ranging from 0 to 12. It consists of 4 subscores (stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and physician global assessment [PGA]), each graded from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
1402723|NCT01240915|Secondary|Percentage of Participants in Clinical Response at Week 8|Clinical response is defined as a decrease in total Mayo score from baseline of at least 3 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
1402724|NCT01240915|Secondary|Percentage of Participants With Endoscopic Response at Week 8|Endoscopic response is defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
1402725|NCT01240915|Secondary|Percentage of Participants With Decrease From Baseline of at Least 1 Point in Rectal Bleeding Mayo Subscore at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes). A decrease from baseline score indicates improvement.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
1402726|NCT01240915|Secondary|Percentage of Participants in Clinical Remission at Week 8|Clinical remission is defined as a total Mayo score of 2 points or lower, with no individual subscores exceeding 1 point.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
1402727|NCT01240915|Secondary|Percentage of Participants in Endoscopic Remission at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding). Endoscopic remission is defined as modified Baron Endoscopic Score equal to 0.|Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
1402728|NCT01240915|Secondary|Percentage of Participants With Rectal Bleeding Mayo Subscore of Zero at Weeks 4, 8, 12, and 16|Mayo subscores for rectal bleeding range from 0 to 3 (0=no blood seen; 1=streaks of blood with stool less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes).|Week 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||percentage of participants|||Number
1402729|NCT01240915|Secondary|Fold Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 8, 12, and 16|CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||fold change||Geometric Coefficient of Variation|Geometric Mean
1402730|NCT01240915|Secondary|Fold Change From Baseline in Fecal Calprotectin at Weeks 4, 8, 12, and 16|Fecal calprotectin, a very stable marker, is a 36kDa calcium and zinc binding protein which is neutrophil-derived. It represents 60% of cytosolic proteins in granulocytes and is a measurement of neutrophil migration to the gastrointestinal tract.|Baseline, Weeks 4, 8, 12 and 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||fold change||Geometric Coefficient of Variation|Geometric Mean
1402731|NCT01240915|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP). Criteria for vital sign values meeting potential clinical concern included: SBP <90 millimeters of mercury (mm Hg) and >=30 mm Hg increase/decrease from baseline, DBP <50 mm Hg and >=20 mm Hg increase/decrease from baseline, pulse rate <40 or >120 beats per minute (bpm),|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
1402732|NCT01240915|Secondary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities with or without regard to baseline abnormality was assessed. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte sedimentation rate); chemistry (blood urea nitrogen and creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase); other (follicle-stimulating hormone, human chorionic gonadotropin, stool microbiology, creatinine kinase, direct bilirubin, indirect bilirubin, gamma-glutamyl transferase, international normalized ratio.|Baseline up to Week 24|The safety analysis population consisted of all participants who received at least 1 dose of study medication; n=the number of participants analyzed at that time point in the respective arms.|||participants|||Number
1402733|NCT01240915|Secondary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 12 and Week 16|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline, Week 12, Week 16|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
1402734|NCT01240915|Primary|Number of Treatment-Emergent AEs by Severity|The intensity grades were defined as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||adverse events|||Number
1402735|NCT01240915|Primary|Number of Participants With Treatment-Emergent AEs by System Organ Class (SOC)||Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
1402736|NCT01240915|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 52|The safety analysis population consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
1402737|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 8|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint.|||scores on a scale||Standard Deviation|Mean
1402799|NCT01240785|Secondary|Maternal Weight Gain Per Arm||up to on the average 40 weeks of gestation||||kg||Standard Deviation|Mean
1402800|NCT01240785|Secondary|Pregnancy Induced Hypertension Per Arm|Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg|up to on the average 40 weeks of gestation||||participants|||Number
1402738|NCT01240915|Primary|Change From Baseline in Rectal Bleeding Mayo Subscore at Week 4|Mayo Score is an instrument designed to measure disease activity of ulcerative colitis. Mayo subscores for rectal bleeding range from 0 to 3, with higher scores indicating more severe disease.|Baseline and Week 4|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint; n=the number of participants analyzed at that time point in the respective arms.|||scores on a scale||Standard Deviation|Mean
1402739|NCT01240915|Primary|Change From Baseline in Endoscopic Score (as Measured by Modified Baron Score) at Week 8|Modified Baron Score is an instrument designed to measure endoscopic activity of ulcerative colitis. It classifies the mucosal inflammation in 4 grades (0=normal, 1=granular mucosa with an abnormal vascular pattern, 2=friable mucosa, 3=microulceration with spontaneous bleeding, 4=gross ulceration with spontaneous bleeding).|Baseline and Week 8|The full analysis set included all available observed data from all randomized participants who completed at least 1 infusion and were either withdrawn as a treatment failure, or had at least 1 valid post-dose measurement on a primary endpoint. Baseline observation carried forward (BOCF) was used for treatment failures.|||scores on a scale||Standard Deviation|Mean
1402740|NCT01240902|Secondary|Prosthetic Valve Dysfunction (PVD)|"PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:~Peak velocity >4 m/s~Mean gradient >35 mmHg~EOA < 0.8 cm2~TVIV1 / TVIV2 < 0.25"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||percentage of participants|||Number
1402741|NCT01240902|Secondary|Procedural Success|"Medtronic CoreValve® System subjects only.~Defined as device success and absence of in-hospital MACCE."|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.|||percentage of participants|||Number
1402742|NCT01240902|Secondary|Device Success|"Medtronic CoreValve® System subjects only.~Defined as:~Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,~Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),~Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)~Only one valve implanted in the proper anatomical location"|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.|||percentage of participants|||Number
1402743|NCT01240902|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge|Participant Population= Consisted of all subjects with an attempted implant procedure.|||days||Standard Deviation|Mean
1402744|NCT01240902|Secondary|Index Procedure Related MAEs||Procedure|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants|||Number
1402745|NCT01240902|Secondary|Strokes and Transient Ischemic Attacks (TIAs)|Strokes (of any severity) and TIAs|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1402746|NCT01240902|Secondary|Cardiovascular Deaths and Valve Related Deaths||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1402747|NCT01240902|Secondary|Aortic Valve Hospitalizations||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure|||percentage of participants, Kaplan-Meier|||Number
1402748|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||percentage of participants|||Number
1402749|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:~- Transvalvular Mean Gradient"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||mmHg||Standard Deviation|Mean
1402750|NCT01240902|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measures:~- Effective Orifice Area (EOA)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with a valve implanted.|||cm^2||Standard Deviation|Mean
1402751|NCT01240902|Secondary|Quality of Life (QoL) Change|"QoL summary score change from baseline using the following measures:~Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||units on a scale||Standard Deviation|Mean
1402752|NCT01240902|Secondary|Ratio of Days Alive Out of Hospital Versus Total Days Alive||1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||ratio of days alive and out of hospital||Standard Deviation|Mean
1402753|NCT01240902|Secondary|Change in Distance Walked During 6-Minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|30 day, 1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||meters||Standard Deviation|Mean
1402801|NCT01240785|Primary|Birth Weight Per Arm|birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies|delivery||||g||Standard Deviation|Mean
1404217|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Threshold|RA pacing threshold results were reported for implant|implant|56 CRT-D and 11 ICD patients had data available at implant|||volts (V)||Standard Deviation|Mean
1402754|NCT01240902|Secondary|Change in NYHA Class|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.~New York Heart Association (NYHA) Classification:~Class I: Subjects with cardiac disease but without resulting limitations of physical activity.~Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||average classification level change||Standard Deviation|Mean
1402755|NCT01240902|Secondary|Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1402756|NCT01240902|Secondary|Major Adverse Events (MAEs)|"MAEs Include:~MACCE~Acute Kidney Injury~Cardiac Tamponade~Prosthetic Valve Dysfunction~Cardiogenic Shock~Valve Endocarditis~Life-Threatening, Disabling or Major Bleeding~Major Vascular Complication~Cardiac Perforation~Device Migration/Valve Embolism"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1402757|NCT01240902|Secondary|The Occurrence of Individual MACCE Components|"Individual MACCE Components Include:~All Cause Mortality~MI~All stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1402758|NCT01240902|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~All Cause Mortality~Myocardial infarction (MI)~All Stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 month, 1 year, 2 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1402759|NCT01240902|Primary|Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality|All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)|1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
1402760|NCT01240863|Secondary|Change From Baseline to Endpoint in the Double-Blind Treatment Phase in Electrocardiogram (ECG) Parameters|A 12-lead ECG was conducted at baseline and the last visit during the double-blind treatment period (week 12, or early termination).|Baseline (end of Open-Label Titration Period), Endpoint (last visit up to Week 12) of the Double-blind treatment period|FAS of participants contributing baseline and endpoint data.|||msec||Standard Deviation|Mean
1402761|NCT01240863|Secondary|Current Opioid Misuse Measures (COMM) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods|"The COMM was a clinician rated scale developed as a brief self report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.~The COMM was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination."|Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402762|NCT01240863|Secondary|Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Double-Blind Treatment Periods|"The ABC was a clinician rated scale that consisted of a brief (20 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as one point, and points were added to calculate the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen).~The ABC was to be performed at visits 2 and 7 (beginning and end of Open-label Titration period) and weeks 1, 4, 8, and 12 (Double-blind Treatment period) or early termination."|Baseline for Open-Label Titration period, Baseline for Double-Blind Treatment period (which is also the end of the Open-Label Titration period), Weeks 1, 4, 8, 12, and Endpoint (last visit up to Week 12) of the Double-blind Treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402763|NCT01240863|Secondary|Clinical Opiate Withdrawal Scales (COWS) Scores During the Double-Blind Treatment Period|"The COWS was a clinician rated scale used to measure a participant’s signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at day 0 and weeks 1, 2, 4, 8, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5.~A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows:~0 to 4=normal~5 to 12=mild~13 to 24=moderate~25 to 36=moderately severe~>36=severe"|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402837|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 24 weeks|||||||
1404218|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Threshold|RV pacing threshold results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit.|||volts (V)||Standard Deviation|Mean
1402764|NCT01240863|Secondary|Subjective Opiate Withdrawal Scales (SOWS) Scores During the Double-Blind Treatment Period|The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at weeks 8 and 12 or early termination. The SOWS was a self administered questionnaire used to measure a participant’s signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (eg, my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.|Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to Week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402765|NCT01240863|Secondary|Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Uric acid: M>=625, F>=506 μmol/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 %~Urinalysis: blood (hemoglobin) and total protein: >=2 unit increase from baseline"|Day 1 up to Day 128 in Double-Blind Treatment period|Full analysis set including participants with laboratory assessments|||Participants|||Count of Participants
1402766|NCT01240863|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 up to Day 128 in Double-Blind Treatment period|FAS|||Participants|||Count of Participants
1402767|NCT01240863|Secondary|Participants With Adverse Events|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Day 52 in Open-Label Titration; Day 1 up to Day 128 in Double-Blind Treatment period|Safety analysis set (Open-Label Titration) and FAS (Double-Blind Treatment)|||Participants|||Count of Participants
1402768|NCT01240863|Secondary|Brief Pain Inventory – Short Form (BPI-SF) Pain Interference Mean Score During the Double-Blind Treatment Period|For pain interference, the BPI-SF used numerical scales to measure how much pain had interfered with 7 daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep in the past 24 hours. The scale used an 11 point Likert scale; range: 0 [does not interfere] to 10 [completely interferes]. BPI pain interference was typically scored as the mean of the 7 interference items. This mean could be used if at least 4 of 7 items had been completed on a given administration.|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402769|NCT01240863|Secondary|Short-Form Health Survey (SF-36) Physical and Mental Component Summary Scores at Baseline, Week 12 and Endpoint|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline (end of Open-Label Titration Period), Week 12 and Endpoint (last visit up to week 12) of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402770|NCT01240863|Secondary|Clinician Global Impression of Severity (CGI-S) of Illness Scores During the Double-blind Treatment Period|"The CGI-S is a clinician-rated scale that assesses the severity of the patient’s pain condition and response to the treatment. Severity of illness, as related to moderate to severe pain, consists of the following 7 categories:~1 normal–shows no sign of illness,~2 borderline ill,~3 mildly (slightly) ill,~4 moderately ill,~5 markedly ill,~6 severely ill, and~7 among the most extremely ill (Guy 1976).~The clinician assesses the severity of the patient’s condition, based on the clinician’s total clinical experience with patients with this condition, in response to treatment.~Endpoint values are the last observed postbaseline data."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402810|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.|||Titers||95% Confidence Interval|Geometric Mean
1402771|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Endpoint|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life~Endpoint values are the last observed postbaseline data."|Endpoint of the Double-blind Treatment Period (up to week 12)|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
1402772|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 12|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life"|Week 12 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
1402773|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 8|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life"|Week 8 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
1402774|NCT01240863|Secondary|Patient Assessment of Function (PAF) at Week 4|"The PAF is a self-administered questionnaire used to measure patients’ assessment of their own ability to function in normal activities. Answers to the 7 questions were rated on a 7 point scale in which 1 was very much worsened and 7 were very much improved since the start of the study.~The seven functional areas are:~ability to go to work~ability to perform at work (includes both work outside the home and housework)~ability to walk~ability to exercise~ability to participate in social events~ability to have sex~ability to enjoy life"|Week 4 of the Double-blind Treatment Period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
1402775|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Endpoint|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study.~Endpoint values are the last observed postbaseline data."|Endpoint of the Double-blind Treatment Period (up to week 12)|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
1402776|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 12|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 12 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
1402777|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 8|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 8 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
1402778|NCT01240863|Secondary|Clinician Assessment of Patient Function (CAPF) at Week 4|"Clinicians assessed participants across 5 dimensions:~Patients general activities~Patients walking ability~Patients ability to work/perform activities of daily living~Patients relationships with others~Patients enjoyment of life~Assessments are rated on a 7-point scale, in which 1 is very much worsened and 7 is very much improved since the start of the study."|Week 4 of the Double-blind Treatment Period|FAS of participants with assessments at the timeframe|||Participants|||Count of Participants
1402779|NCT01240863|Secondary|Weekly Average Worst Pain Intensity (WPI) Scores During the Double-blind Treatment Period|"The WPI was recorded by the patient in the e-diary daily throughout the study, based on the Numeric Rating Scale (NRS-11). Participants were asked to select the number that best described their WPI over the previous 24 hours. Values were averaged for each week.~The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402780|NCT01240863|Secondary|Weekly Average Pain Intensity (wAPI) Scores During the Double-blind Treatment Period|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.~The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||units on a scale||Standard Deviation|Mean
1402781|NCT01240863|Secondary|Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 50%|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.~The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
1402782|NCT01240863|Secondary|Participants With a Weekly Average Pain Intensity (wAPI) Increase From Baseline Exceeding 33%|"The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug.~The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable."|Baseline (end of Open-Label Titration Period), Weeks 1, 2, 4, 8, and 12 of the Double-blind treatment period|Full analysis set. Participants contributing to each time point are included in the number analyzed.|||Participants|||Count of Participants
1402783|NCT01240863|Secondary|Kaplan-Meier Estimates for Time to Discontinuation From the Study|Kaplan-Meier estimates for time to discontinuation from the study (due to any cause) was calculated as the number of days since participants were randomly assigned to study drug treatment, ie, the difference between the date the participants withdrew and the date participants were randomly assigned to study drug treatment. The censoring flag was set to 0 if a participant was withdrawn from study drug treatment early and was set to 1 if the participant completed the 12 week treatment period. Censoring time was calculated as the difference of treatment completion date (ie, date of last study drug administration) and date participant was randomly assigned to study drug treatment.|Day 1 to Week 12 of the double-blind treatment period|Full analysis set|||days||Inter-Quartile Range|Median
1402784|NCT01240863|Secondary|Percentage of Participants Withdrawn From the Study During the Double-Blind Treatment Period By Reason|Percentage of participants who withdrew from the study during the double-blind treatment period. Withdrawal is due to any cause, including lack of efficacy.|Day 1 to Week 12 of the double-blind treatment period|Full analysis set|||percentage of participants|||Number
1402785|NCT01240863|Primary|Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)|"The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration period, before patients were randomly assigned study drug. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.~The Numeric Rating Scale (NRS-11) is an 11–point scale for patient self-reporting of pain on a Likert-type scale in which 0 is no pain and 10 is the worst pain imaginable. Negative change from baseline values indicate lessening in pain intensity."|Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period|Full analysis set (FAS). One placebo patient was withdrawn from the study prior to receiving drug in the Double-blind Treatment period and is not included in the FAS. In the case of missing week-12 data due to early withdrawal from the study, or excessive rescue medication usage, the wAPI for week 12 was imputed.|||units on a scale||Standard Error|Least Squares Mean
1402786|NCT01240811|Secondary|Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis|Changes in vaginal flora as assessed by qPCR quantitation of H2O2 producing Lactobacilli species and Gardnerella vaginalis. Quantitative PCR (qPCR) results are reported as log concentration of gene copies/swab specimen.|2 Months||||log gene copies/swab||Full Range|Median
1402787|NCT01240811|Secondary|Change in Vaginal Flora|Changes in vaginal flora as assessed by Nugent score The Nugent score is calculated by microscopically assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with bacterial vaginosis, 4-6 is consistent with intermediate vaginal flora, and 0-3 is normal vaginal flora.|2 Months||||units on a scale||Full Range|Median
1402788|NCT01240811|Primary|%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium|Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety|2 months|All 40 participants who completed the study were included in the analysis. There were no lost-to-follow up participants. One participant withdrew and one participant was excluded post-enrollment. Both of these participants were replaced to fill our goal enrollment of 40 participants in the study.|||% of T-cells expressing CCR5||Standard Deviation|Mean
1402789|NCT01240785|Secondary|Child Outcome at 2 Years Per Arm|neuropsychological and motor skills testing|2 years after birth|||||||
1402790|NCT01240785|Secondary|Neonate Transfer to Intensive Care Unit Per Arm||0-5 days after delivery||||participants|||Number
1402791|NCT01240785|Secondary|Apgar Score at 5 Min After Delivery Per Arm|Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome|5 minutes after delivery||||units on a scale||Standard Deviation|Mean
1402792|NCT01240785|Secondary|Neonatal Hyperbilirubinemia Per Arm||0-3 days after delivery||||participants|||Number
1402793|NCT01240785|Secondary|Neonatal Hypoglycemia Per Arm||0-24 h after delivery||||participants|||Number
1402794|NCT01240785|Secondary|Shoulder Dystocia Per Arm||delivery||||participants|||Number
1402795|NCT01240785|Secondary|Induction of Delivery Per Arm||delivery||||participants|||Number
1402802|NCT01240746|Other Pre-specified|Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 3 years to <9 years with available data for the relevant endpoint.|||Participants|||Number
1402803|NCT01240746|Other Pre-specified|Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.|"Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.~Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: >103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable.~Solicited Injection site reactions (Age 24 Months to < 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 6 months to <36 months with available data for the relevant endpoint.|||Participants|||Number
1402804|NCT01240746|Primary|Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post-vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 Years with valid serology results for the particular antigen.|||Titers||95% Confidence Interval|Geometric Mean
1402805|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
1402806|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
1402807|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post-vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 years with valid serology results for the particular antigen.|||Participants|||Number
1402808|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)."|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.|||Participants|||Number
1402809|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens.|||Participants|||Number
1402823|NCT01240551|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|date treatment consent signed to date off study, approximately 52.5 months||||Participants|||Count of Participants
1402811|NCT01240746|Other Pre-specified|Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre vaccination HAI titer <1:10 and a post vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and a four-fold increase in post-vaccination."|Day 28 post final vaccination|Seroconversion with respect to vaccine antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
1402812|NCT01240746|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 40 (l/dil)"|Day 28 post final vaccination|Seroprotection against influenza vaccine antigens was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.|||Participants|||Number
1402813|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.|||Titers||95% Confidence Interval|Geometric Mean
1402814|NCT01240746|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.|||Titers||95% Confidence Interval|Geometric Mean
1402815|NCT01240746|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥four-fold increase in post-vaccination"|Day 28 post final vaccination|Seroconversion with respect to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
1402816|NCT01240746|Primary|Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 28 post final vaccination|Geometric mean titers (GMT) to influenza vaccine A antigens were determined in randomized and vaccinated participants, per-protocol population. The GMT data for antigen A/Victoria/210/2009 and A/California/07/2009 were pooled for participants vaccinated with either 2010-2011 TIV or the investigational TIV. Data presented in column for Group 1.|||Titers||95% Confidence Interval|Geometric Mean
1402817|NCT01240590|Secondary|Tumor Growth Rate Constant|Difference in time (days) required for the treated tumors to reach a predetermined target size.|21 days|This outcome measure was not analyzed because few if any re-assessments were done, thus there was not enough data to assess the growth rate constant on the patients.||||||
1402818|NCT01240590|Secondary|Number of Participants Who Underwent Medically-Necessary Interventions|Enrolled participants who had surgical procedures deemed medically necessary for their clinical care.|4.5 years||||Participants|||Count of Participants
1402819|NCT01240590|Primary|Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II)|Here is the number of participants with serious and non-serious adverse events. For a detailed list of adverse events, see the adverse event module.|4 years, 6 months and 26 days||||participants|||Number
1402820|NCT01240590|Primary|Progression Free Survival (Phase II)|Progression free survival (PFS) is defined as the duration of time from start of study treatment to time of progression. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as: Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 weeks|The outcome was not met because the patients died and were not scanned before their death.||||||
1402821|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Crolibulin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks||||mg/m^2|||Number
1402822|NCT01240590|Primary|Maximum Tolerated Dose (MTD) of Cisplatin (Phase I)|MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE).|3 weeks||||mg/m^2|||Number
1402824|NCT01240551|Primary|Number of Participants With Present or Not Present Bone Metastasis|Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.|Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.|Patient with known prostate cancer. One group with known metastatic bone disease, based on prior clinical imaging scan (Tc-99m bone scan or NaF-18 bone scan or CT, and a second group with clinical risk factors for obtaining bony metastatic disease (i.e. pelvic soft tissue mets, high PSA (prostate specific antigen) blood levels).|||Participants|||Count of Participants
1402825|NCT01240382|Primary|Mean Change in Rose Bengal Staining Score From Baseline|"Rose bengal staining were scored according to the protocol by Shimmura et al. The ocular surface was divided into 5 zones: nasal and temporal conjunctival, and upper, middle, and lower corneal areas. A staining score between 0 and 3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 15 points.0 is better.~The degree of staining with Rose bengal dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 2 subjects were excluded from analysis because there was no available efficacy data in rose bengal staining.|||points||Standard Deviation|Mean
1402826|NCT01240382|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.~The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued (LOCF))|Efficacy analysis was performed full analysis set (FAS). In 0.1% sodium hyaluronate ophthalmic solution group, 1 subject was excluded from analysis because there was no available efficacy data in fluorescein staining.|||points||Standard Deviation|Mean
1402827|NCT01240356|Primary|Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination|The neurological examinations comprised assessments of mental status and orientation, cranial nerve examination, muscle strength and tone, deep tendon reflexes, sensory testing, coordination, and gait.|2-3 hours after treatment||||participants|||Number
1402828|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)|A modified Rankin Scale (mRS) score of 0 or 1 indicates an excellent outcome. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS scale ranks patients from 0 to 6 (0 is the best score, 6 is the worst score).|at 3-months from enrollment|ITT with modified Ranking scores (mSR) at 90 days. % displayed is % with excellent outcome (mRS of 0-1).|||percentage of patients||95% Confidence Interval|Number
1402829|NCT01240356|Secondary|Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale|The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. Each item on the NIHSS scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|within 90 days of enrollment||||percentage of patients||95% Confidence Interval|Number
1402830|NCT01240356|Secondary|Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems|Ischemic stroke patients: 2-hour rates of arterial complete and partial recanalization as measured using standard Transcranial Doppler Ultrasound systems.|2-3 hours after treatment|ITT - Percent of patients who had complete recanalization after treatment.|||percentage of patients||95% Confidence Interval|Number
1402831|NCT01240356|Secondary|Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD|Phase I - A group of healthy volunteers will be assessed to determine the feasibility and activity of hands-free (HF) transcranial Doppler (TCD). Adverse events include subject complaints regarding discomfort of the device and dermatological adverse events as evidenced by a detailed physical examination of skin integrity post-insonation.|2-3 hours after treatment|ITT|||participants|||Number
1402832|NCT01240356|Primary|Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage|Phase II: Determine if the Hands-Free TCD will not result in higher than 10% rate of symptomatic intracerebral hemorrhage (ICH) within 24 hours (defined as clinical worsening > 4 NIH Stroke Scale (NIHSS) points and presence of hemorrhage on CT scan that in the opinion of the treating physician is causatively related to ICH on CT) in 0-3 hours acute stroke patients treated with intravenous tissue-type plasminogen activator (IV-t-PA).|within 24 hours|Intention to Treat (ITT)|||percentage of patients||95% Confidence Interval|Number
1402833|NCT01240356|Primary|Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain|Phase I : Imaging of the brain via MRI scans was performed to determine if the Hands-Free transcranial Doppler (TCD) system results in any BBB-disruption or deterioration in permeability.|2-3 hours after treatment||||participants|||Number
1402834|NCT01240330|Secondary|Subject Comfort|Subject comfort was measured on a scale 1 to 5 (1=negative response; 5=positive response) during the sleeve installation, during use, and completion.|10 min therapy||||Units on a Scale||Standard Deviation|Mean
1402835|NCT01240330|Secondary|PFV Percent Augmentation|Peak Flow Velocity (PFV) from the compression phase subtracted from the PFV from the decompression phase divided by the PFV from the decompression phase expressed as the percent augmentation.|3 measurements/10 minute therapy||||percentages||Standard Deviation|Mean
1402838|NCT01240200|Secondary|Blood Glucose (Low Blood Glucose)|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Number of episodes of nocturnal hypoglycemia, any hypoglycemia, severe hypoglycemia~Accuracy of insulin dosing at weeks 0,12 and 24"|at 24 weeks|||||||
1402842|NCT01240200|Secondary|Blood Glucose Control|"Secondary outcomes include differences between treatment regimens in any of the following measures:~Percent of subjects with A1c <7.0% without hypoglycemia, A1c and mean fasting blood glucose at the end of each 12 week treatment period and percent with mean fasting glucose <130 mg/dL without hypoglycemia"|at 0 weeks|||||||
1402843|NCT01240200|Primary|Treatment Satisfaction|The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.|at 24 weeks|||||||
1402844|NCT01240200|Primary|Treatment Satisfaction|The treatment satisfaction scores were obtained from the Diabetes Treatment Satisfaction Questionnaire: Status (DTSQs). The questionnaire contains eight items scored on a seven-point scale (0-6). DTSQs scores range from, e.g, 6 = very satisfied to 0 = very dissatisfied. The total satisfaction score when using the DTSQs ranges from 0 to 36; and the total score is obtained from summed scores from questions 1, 4, 5, 6, 7, and 8. This outcome measure is assessed after the first intervention (at 12 weeks into the study).|12 weeks||||units on a scale||Standard Deviation|Mean
1402845|NCT01240200|Primary|Treatment Satisfaction Based on Patient Survey|The primary outcome of the study is to determine differences in treatment satisfaction scores in elderly patients with diabetes treated with basal insulin delivered via a pen device versus a syringe.|at 0 weeks|||||||
1402846|NCT01240135|Secondary|Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score|The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.|||units on a scale||Standard Deviation|Mean
1402847|NCT01240135|Primary|Lens Fit|As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.|Day 14 of lens wear|Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.|||percentage of acceptable fit|||Number
1402848|NCT01240122|Secondary|Overall Ocular Comfort|All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.|Day 4|All subjects who completed the study were included in the analysis per protocol.|||score on a scale||Standard Deviation|Mean
1402849|NCT01240122|Secondary|Subjective Solution Preference|All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.|Day 4|All subjects who completed the study were included in the analysis per protocol.|||Participants|||Count of Participants
1402850|NCT01240122|Primary|Corneal Staining by Wear Time|All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.|1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4|Corneal Staining Severity at Scheduled Visits (Safety Population)|||participants|||Number
1402851|NCT01239992|Other Pre-specified|LDL-cholesterol|Percent change of LDL-cholesterol at 12 weeks compared to baseline|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
1402852|NCT01239992|Secondary|Fasting Triglycerides|Percent change of fasting triglycerides at 12 weeks compared to baseline|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
1402853|NCT01239992|Secondary|HDL Cholesterol|Percent change of HDL-cholesterol at 12 weeks compared to baseline.|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
1402854|NCT01239992|Primary|Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test|Percent change of incremental AUC at 12 weeks compared to baseline.|baseline and 12 weeks after treatment||||percentage change||Standard Deviation|Mean
1402855|NCT01239797|Secondary|Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores|"Outcome measure reports the change from baseline of the mean score of pain severity and the change from baseline of the mean score of pain interference between the two treatments using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 (No pain, No interference) to 10 (Pain as bad as you can imagine, Highest imaginable interference) numeric rating scale."|Baseline to Study Completion (up to 7 years)||2019-10-31|10/2019||||
1402856|NCT01239797|Secondary|Median Overall Survival (OS)|Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|Randomization to 427 deaths (approximately 7 years)||2019-10-31|10/2019||||
1402857|NCT01239797|Primary|Objective Response Rate (ORR)|Objective response rate (ORR) defined as the proportion of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.|Randomization to end of treatment (approximately 2 years)|All participants randomized to any treatment group|||percentage of participants||95% Confidence Interval|Number
1402858|NCT01239797|Primary|Median Progression Free Survival (PFS)|Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.|Randomization until 326 events (approximately 2 years)|All participants randomized to any treatment group|||months||95% Confidence Interval|Median
1402859|NCT01239745|Secondary|Overall Survival|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (up to Month 36)|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1402860|NCT01239745|Secondary|Recurrence-free Survival|Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.|Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1402861|NCT01239745|Secondary|Time to Discontinuation||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1402862|NCT01239745|Secondary|Number of Participants With Reasons for Discontinuation From Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1402863|NCT01239745|Secondary|Percentage of Participants Who Discontinued the Study Medication||Baseline up to Month 36|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1402864|NCT01239745|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||participants|||Number
1402865|NCT01239745|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||participants|||Number
1402866|NCT01239745|Primary|Number of Participants With Adverse Events (AEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to Month 36|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||participants|||Number
1402867|NCT01239732|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).|3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|Previous studies linking CA-125 levels with bevacizumab exposure as a potential secondary outcome measure for PFS did not produce any reliable information. Therefore, it was decided that data for this outcome measure should not be analyzed, as agreed with the study steering committee.||||||
1402868|NCT01239732|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.|First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years|ITT population|||months||95% Confidence Interval|Median
1402887|NCT01239394|Secondary|Overall Response Rate (ORR)|"Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR).~Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT"|1-month post-treatment||||percentage of patients|||Number
1402996|NCT01238341|Secondary|Successful Cannulation of the Duct of Intent|Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.|During procedure, up to 3 hours||||ERCPs|Participants||Number
1402869|NCT01239732|Secondary|Duration of Objective Response (DOR)|DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population|||months||95% Confidence Interval|Median
1402870|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria|Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.|RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1402871|NCT01239732|Secondary|Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria|CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).|3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1402872|NCT01239732|Secondary|Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1402873|NCT01239732|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.|Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years|Intent to treat population included all participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
1402874|NCT01239732|Primary|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)|Safety population|||percentage of participants|||Number
1402875|NCT01239680|Primary|Biological Response as Characterized by Selected Cytokines, Specifically Tumor Necrosis Factor Alpha (TNFα), Interleukin One (IL-1β), and Interleukin Six (IL-6).|Biological response as characterized by selected cytokines, specifically tumor necrosis factor alpha (TNFα), interleukin one (IL-1β), and interleukin six (IL-6). These are measured using ELISA. Baseline values are expected to be either unobtainable, or in any case less than 50 picograms/ml. If there is a significant inflammatory response, values at 24 hours should be more than 100 picograms/ml for TNFα, IL-1β, and IL-6. Our hypothesis is that there will be a difference between study and control group patients of at least 50 picograms/ml in the levels of these cytokines at 24 hours. Cytokine response is quite variable, and the percentage of outliers (with no cytokine response) in either group may be as high as 50%. .|Change from Baseline in Cytokine Levels at 24 hours|The number of participants who had an intervention and completed the study with all 3 required blood draws.||||||
1402876|NCT01239511|Secondary|Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.||6 weeks|||||||
1402888|NCT01239394|Primary|Efficacy: Complete Response Rate (CRR)|"Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR).~Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5 cm in greatest diameter)"|1-month post-treatment||||percentage of patients|||Number
1402889|NCT01239381|Secondary|Median Survival Among Participants With Colorectal Cancer|The median amount of time participants survived from the start of treatment, among the participants with colorectal cancer.|2 years|The 35 participants with colorectal cancer as the primary cancer.|||Months||95% Confidence Interval|Median
1402890|NCT01239381|Secondary|1 Year Local Control Rate Among Participants With Colorectal Cancer|The percentage of participants with local control at one year among the participants with colorectal cancer as the primary cancer.|1 year|Participants with colorectal cancer|||percentage of participants|||Number
1402891|NCT01239381|Secondary|2-year Local Control Rate|The percentage of participants with local control 2 years after the start of study treatment.|2 years||||percentage of participants||95% Confidence Interval|Number
1402892|NCT01239381|Secondary|Median Progression Free Survival|The median amount of time participants survived without cancer progression following the start of study treatment. Progression was assessed using RECIST v1.0. Progressive Disease (PD) is defined as at least a 20% increase in the Longest Diameter (LD) of the lesion, taken as the reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|1 years||||Months||95% Confidence Interval|Median
1402893|NCT01239381|Secondary|Median Overall Survival|The median overall survival (in months) of participants as measured from the start of treatment.|2 years||||Months||95% Confidence Interval|Median
1402894|NCT01239381|Secondary|Median Follow-up Time|The median follow-up time among the 39 participants still alive at the time of analysis, measured from the start of treatment until the time of analysis.|1 year|the 39 participants still alive at the time of analysis|||Months||95% Confidence Interval|Median
1402895|NCT01239381|Primary|Local Control Rate|"The percentage of participants with local control at primary tumor site at one year. Local is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Local control is defined as achieving either Complete response (CR), Partial Response (PR), or Stable Disease (SD).~(CR): Disappearance of entire lesion, with no additional evidence of disease.~(PR): At least a 30% decrease in the (sum of) the longest diameter (LD) of the primary lesion, taken as reference the baseline sum LD.~(SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1 year|The 90 participants that started study treatment|||percentage of participants|||Number
1402896|NCT01239355|Secondary|Overall Survival|Survival will be estimated by the product-limit (Kaplan-Meier) estimator.|Until death, up to 26 months||||Months||95% Confidence Interval|Median
1402897|NCT01239355|Secondary|Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR|Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months||||participants|||Number
1402898|NCT01239355|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression or death, up to 26 months||||Months||95% Confidence Interval|Median
1402899|NCT01239342|Secondary|Time to Failure (TTF)|TTF defined as Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date.|Time interval between the date of treatment and the date of disease progression, date of death, date of treatment discontinuation due to severe toxicity or last follow-up date, assessed up to 5 years|No participants analyzed. Data not collected.||||||
1402900|NCT01239342|Secondary|Median Overall Survival (OS) in Months|Overall survival reported in months as time interval between the date of treatment and the date of death or last follow-up.|Time interval between the date of treatment and the date of death or last follow-up, assessed up to 5 years||||Months||Full Range|Median
1402901|NCT01239342|Secondary|Overall Response Rate (ORR) Defined as Complete Response (CR) + Partial Response (PR)|Response for CR + PR defined by RECIST version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.|Up to 5 years|One participant in each group left study before restaging therefore are excluded from response outcome analysis.|||percentage of participants|||Number
1402902|NCT01239342|Secondary|Summary of Selected Toxicities Grade 3 or Greater Toxicity Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Adverse Events (AEs) list of reported events with associated intervention agent in a uniform presentation of events. The method of Thall, Simon and Estey (1995, 1996) was used to collect study participants’ safety data summarized by treatment arm, category, severity and relevance. Comprehensive listing of AEs collected on study can be found in Adverse Event section separated by severity, Serious and Other AEs and represented by treatment arm, organ system-category within defined severity.|Up to 5 years||||Toxicities|||Number
1402918|NCT01239056|Secondary|Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS).||6 to 12 weeks after baseline||||participants|||Number
1402997|NCT01238341|Primary|Papilla or Duct-enterostomy Was Reached||During procedure, up to 3 hours||||ERCPs|Participants||Number
1402903|NCT01239342|Secondary|Clinical Benefit Defined as Number of Participants With Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)|Clinical benefit defined as participants' with CR+PR+SD assessed using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Repeat radiologic studies to evaluate disease progression or response (in accordance with restaging of disease) every 8 weeks. Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase >5 mm. (Note: appearance 1/+ new lesions considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters.|Up to 5 years|One participant in each group left study before restaging therefore are excluded from outcome analysis.|||Participants|||Count of Participants
1402904|NCT01239342|Primary|Median Progression Free Survival (PFS) in Months|PFS defined as Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first. Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.|Time interval between date of treatment and date of disease progression, date of death or last follow-up date, whichever occurs first, assessed up to 5 years|One participant in each group left study before restaging therefore are excluded from response outcome analysis.|||Months||95% Confidence Interval|Median
1402905|NCT01239316|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data|||penetration rate||Full Range|Median
1402906|NCT01239316|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patient with sustained objective response|||months|||Number
1402907|NCT01239316|Primary|Pharmacokinetics (Plasma) of GDC-0449|plasma GDC-0449 concentration of day 21 in first course|up to 12 month|Patients who have day 21 plasma GDC-0449 concentration data available|||uM||Full Range|Median
1402908|NCT01239316|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years||||months||95% Confidence Interval|Median
1402909|NCT01239316|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months||||participants|||Number
1402910|NCT01239212|Secondary|Number of Participants With Adverse Events|Participants' medical records will be reviewed for any adverse effects of the medication seen in the 24 hours after the loading dose.|24 hours after dose|||||||
1402911|NCT01239212|Secondary|Change in Vital Sign Baseline|Short term treatment-emergent adverse effects of levetiracetam will be measured by change from vital sign baseline in the 24 hours after the dose.|24 hours after loading dose|||||||
1402912|NCT01239212|Primary|Pharmacokinetic Profile|3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm.|5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)|all participants had adequate levels drawn for analysis|||ml/min/kg||Full Range|Median
1402913|NCT01239121|Secondary|Medication-related Symptoms|Patient's self-report of medication-related symptoms by telephone questionnaire|Up to 1 month after hospital discharge|"For this outcome 66 and 87 participants unable to be reached by telephone in first and second arms, respectively.~Outcome not ascertained in the third arm because those participants were not hospitalized."|||participants|||Number
1402914|NCT01239121|Secondary|Adverse Drug Events|Actual harm to patient from hospital medication discrepancies by record review|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.|||participants|||Number
1402915|NCT01239121|Primary|Transition Drug Risk|Rating of potential for harm to patient from hospital medication discrepancies by record review. Minimum=0 Maximum=no maximum. Higher values represent increased detection of medication discrepancies. Although medication discrepancies are undesirable, increasing their detection might facilitate prevention of adverse drug events.|During hospital stay and up to 1 month after hospital discharge|Outcome not ascertained in the third arm because those participants were not hospitalized.|||units: risk-weighted discrepancies||Standard Deviation|Mean
1402916|NCT01239056|Secondary|Adverse Events||1 year||||participants|||Number
1402917|NCT01239056|Primary|Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen|"Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst .~Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst."|baseline||||participants|||Number
1402919|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
1402920|NCT01239043|Other Pre-specified|Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine|Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine and serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
1402921|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1402922|NCT01239043|Other Pre-specified|Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
1402923|NCT01239043|Other Pre-specified|Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.|Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Participants|||Number
1402924|NCT01239043|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 28 post-vaccination|GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1402925|NCT01239043|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.~Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - > 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF."|Day 0 to Day 7 post-vaccination|Solicited reactions were assessed in all subjects who received at a dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
1402926|NCT01238991|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the MMSE scores were not summarized.||||||
1402927|NCT01238991|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the NTB scores were not summarized.||||||
1402928|NCT01238991|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the DAD scores were not summarized.||||||
1402961|NCT01238640|Primary|AUC(0-∞)|AUC (0-∞) is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. It is obtained from calculating AUC (0-t) plus AUC (t-∞).|10 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
1402929|NCT01238991|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).|Baseline up to 24 Months|The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the ADAS-Cog scores were not summarized.||||||
1402930|NCT01238991|Other Pre-specified|Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the IgM data were not summarized.||||||
1402931|NCT01238991|Other Pre-specified|Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study|Baseline of preceding studies to month 24 of this study (Week 210)|The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection.|||Units/mL||95% Confidence Interval|Geometric Mean
1402932|NCT01238991|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.|Baseline of the preceding studies through 24 months of this study|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.|||Participants|||Number
1402933|NCT01238991|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.||||||
1402934|NCT01238991|Primary|Number of Treatment Emergent Adverse Events (AEs) by Severity|Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.|||Events|||Number
1402935|NCT01238900|Secondary|Frequency and Severity of Adverse Events (Including Stent Migration)|Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria|up to 12 months|Stent migration was seen in 9/23 patients (5 downstream, 4 upstream). It was without clinical complications except in one case. Post-procedure pain experienced by 1 patient was effectively treated by downgrading the stent size to a smaller diameter.|||participants|||Number
1402936|NCT01238900|Secondary|Ease of Stent Removal|The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).|at time of procedure||||participants|||Number
1402937|NCT01238900|Secondary|Number of Endoscopic Treatments Per Patient|The average number of ERCPs performed per patient required for resolution of benign strictures.|At time of procedure||||endoscopic treatments||Full Range|Mean
1402938|NCT01238900|Primary|Long-term Success Rate in Resolution of Biliary Strictures|Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.|at least 12 months after stent removal|Per-protocol analysis, the 18 participants available for long term success follow-up consisted of: 11 with CP, 3 with OLT, and 4 others. Intention to treat analysis of long-term success consisted of 22 overall patients, 12 CP patients, 3 OLT patients, and 7 other patients. This analysis included all patients lost to follow-up as long-term failures.|||participants|||Number
1402939|NCT01238900|Primary|Short Term Success Rate in the Resolution of Biliary Strictures|Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.|6 months|Of the 23 participants that entered the study, 22 saw short-term success. The population consisted of 14 Chronic pancreatitis patients, 4 postorthotopic liver transplant patients, and 5 others.|||participants|||Number
1402940|NCT01238861|Secondary|Change From Baseline in Mean Fraction Exhaled Nitric Oxide (FeNO) at Week 52|Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||parts per billion||Standard Deviation|Mean
1402962|NCT01238640|Primary|Area Under the Curve [AUC(0-t)]|Bioavailability within the Set Period [AUC(0-t)] is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).|During 10 hours post-dose||||hr*ng/mL||Standard Deviation|Mean
1402941|NCT01238861|Secondary|Change From Baseline in Percentage of Nocturnal Awakening-Free Nights at Week 51-52|Percentage of nocturnal awakening-free nights were analyzed on a bi-weekly basis and compared to baseline scores. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percent nocturnal awakening-free nights||Standard Deviation|Mean
1402942|NCT01238861|Secondary|Change From Baseline in EQ-5D Visual Analog Scale (VAS) at Week 52|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1402943|NCT01238861|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D) Health State Evaluation at Week 52|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems). Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1402944|NCT01238861|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Score at Week 52|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). The AQLQ(S) responses were categorized as improvement (defined as change from baseline >=0.5), no change (defined as change from baseline >= -0.5 to less than [<] 0.5), and worse (defined as change from baseline < -0.5). Data was summarized by each treatment group.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."|||units on a scale||Standard Deviation|Mean
1402945|NCT01238861|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) at Week 52|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed while sitting or standing prior to using any medication (if needed) for asthma. Home PEF was determined separately for morning and evening, and were averaged for each participant. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters per minute||Standard Deviation|Mean
1402946|NCT01238861|Secondary|Change From Baseline in Mean Forced Vital Capacity (FVC) at Week 52|Forced Vital Capacity (FVC) was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Deviation|Mean
1402947|NCT01238861|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline and Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Deviation|Mean
1402948|NCT01238861|Secondary|Change From Baseline in Rescue Medication Use at Week 51-52|Participants were provided inhalers of the same dose (medium- or high-dose) inhaled corticosteroid (ICS) plus long-acting beta antagonist (LABA) combination product as baseline prophylactic medication and continued with same dose throughout the study. Rescue medications such as short-term beta2 agonists were used as first-line treatment for worsening asthma symptoms. Investigator prescribed additional short term asthma controller medications included additional ICS, theophylline, inhaled cromones or antimuscarinics; if asthma symptoms remained mild but not resolved. If asthma symptoms worsened, participants received an oral corticosteroid burst. All rescue medications use with prophylactic medication (+ prophylactic) and without prophylactic medication (- prophylactic) was recorded in asthma symptom dairy by participant. Rescue medication use was analyzed on a bi-weekly basis and compared to baseline scores.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively. Data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms."|||rescue medication per 2 weeks||Standard Deviation|Mean
1402949|NCT01238861|Secondary|Change From Baseline in Mean Asthma Symptom Diary Score at Week 51-52|Asthma Symptom Diary included 7 questions about the participant symptom and the overall impact of treatment on the disease during the study period. Mean scores of the 7 questions were calculated to identify asthma symptom-free days. Asthma Symptom Diary Scores were analyzed on a bi-weekly basis and compared to baseline scores. Overall symptom score=(daytime frequency score + daytime severity score + nighttime severity score)/3, where total score ranges from 0 to 9. Higher score represents worsening. Mean asthma symptom diary score were summarized together for all participants. Mean asthma symptom diary score were summarized together for all participants. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 51-52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1402950|NCT01238861|Secondary|Change From Baseline in Mean Total Nasal Symptoms Score (TNSS) at Week 52|Total Nasal Symptoms Score (TNSS) is a 3-item questionnaire, the sum of nasal symptoms, namely, nasal obstruction (rhinorrhea), nasal congestion, and nasal itching/sneezing. Each symptom was rated on a scale from 0-3, with 0 representing no symptoms, 1 mild, 2 moderate, and 3 severe symptoms. TNSS score was a summation of the 3 individual nasal symptom. TNSS score could range from 0 to 9 where higher score indicates worsening. Data was summarized by each treatment group. In addition, data was summarized together for “EOS+ and EOS- Placebo” arms and “EOS+ and EOS- benralizumab 100 mg” arms.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1402951|NCT01238861|Secondary|Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. ACQ-6 score was summarized together for all participants.|Baseline up to Week 52|"The mITT population included all randomized participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1402952|NCT01238861|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants|Immunogenicity assessment included determination of anti-drug (benralizumab) antibodies in serum samples. ADA positive was defined as a titer >=50 at any point in the study. It was observed at baseline and any visit during the study.|Baseline up to Week 92|The mITT population included all randomized participants who received any dose of investigational product.|||percentage of participants|||Number
1402953|NCT01238861|Secondary|Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The PK Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.|||microgram per milliliter||Standard Deviation|Mean
1402954|NCT01238861|Secondary|Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)||Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52|The Pharmacokinetic (PK) Population included all participants who received at least one dose of benralizumab and had at least one quantifiable PK observation. One participant, randomized to the EOS- placebo group received a single dose of 100 mg benralizumab on Week 16 and was analyzed for PK in the 100 mg benralizumab group.|||microgram per milliliter||Standard Deviation|Mean
1402955|NCT01238861|Secondary|Dose Response in EOS+ Participants||Baseline up to Week 66|Due to change in planned analysis after unblinding of study data, dose response was not performed.||||||
1402956|NCT01238861|Primary|Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants|The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.|Week 1 up to Week 52|The modified intent-to-treat (mITT) population included all randomized participants who received any dose of investigational product.|||AER events/person-year|||Number
1402957|NCT01238848|Primary|Hospitalization Days|hospitalization days|Participants will be followed for the duration of hospitalization, an expected average of 4 days||||days||Standard Deviation|Median
1402958|NCT01238848|Secondary|Length of Oxygen Use|Length of oxygen use (days)|Participants will be followed for the duration of hospitalization, an expected average of 4 days||||days||Standard Deviation|Median
1402959|NCT01238822|Primary|Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items|"Parent and teacher Vanderbilt ADHD Rating Scales - Attention Deficit / Hyperactivity Disorder Total sum score of all 18 ADHD symptom items - range equals 0-54~O - No ADHD symptoms 54 - Highest ADHD symptoms"|end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.|Intent to treat with imputation for missing data.|||Score||Standard Deviation|Mean
1402960|NCT01238640|Secondary|Product Dissolution Time|Product Dissolution Time is the time from administration until the investigational products were completely dissolved.|During 10 hours post-dose||||Minutes||Standard Deviation|Mean
1402972|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Baseline||||units on a scale||95% Confidence Interval|Mean
1402973|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline||||units on a scale||95% Confidence Interval|Mean
1402974|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|Baseline||||units on a scale||95% Confidence Interval|Mean
1402975|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|Baseline||||units on a scale||95% Confidence Interval|Mean
1402976|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|Baseline||||units on a scale||95% Confidence Interval|Mean
1402977|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|Baseline||||units on a scale||95% Confidence Interval|Mean
1402978|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45.|Baseline||||units on a scale||95% Confidence Interval|Mean
1402979|NCT01238575|Secondary|Aberrant Behavior Checklist Hyperactivity Subscale|"The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech.~The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48."|Baseline||||units on a scale||95% Confidence Interval|Mean
1402980|NCT01238575|Secondary|ADHD Rating Scale - Hyperactivity Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1402981|NCT01238575|Secondary|ADHD Rating Scale - Inattention Subscale|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1402982|NCT01238575|Secondary|Aberrant Behavior Checklist Inappropriate Speech Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1402983|NCT01238575|Secondary|Aberrant Behavior Checklist Sterotypy Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1402984|NCT01238575|Secondary|Aberrant Behavior Checklist Social Withdrawal Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1402985|NCT01238575|Secondary|Aberrant Behavior Checklist Irritability Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 – 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45.|8 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1402986|NCT01238575|Secondary|ADHD Rating Scale - Total|The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.|Week 8||||units on a scale||95% Confidence Interval|Least Squares Mean
1402987|NCT01238575|Primary|Aberrant Behavior Checklist Hyperactivity Subscale|The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.|Week 8||||units on a scale||95% Confidence Interval|Least Squares Mean
1402988|NCT01238536|Secondary|Leg Pain NRS|Leg Pain NRS 0-10 scale|12 months||||units on a scale||Standard Deviation|Mean
1402989|NCT01238536|Secondary|Roland Morris Disability Questionnaire (RDQ)|The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.|12 months||||units on a scale||Standard Deviation|Mean
1402990|NCT01238536|Secondary|Pain Numeric Rating Scale|Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week.|6 weeks||||units on a scale||Standard Deviation|Mean
1402991|NCT01238536|Primary|Roland Morris|The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.|6 weeks|6 week follow up rate was 97% (n=193/200, n=193/200).|||units on a scale||Standard Deviation|Mean
1402992|NCT01238471|Secondary|Safety of Propranolol Therapy in Premature Infants|Close monitoring for possible side effects of propranolol in premature infants|4 weeks of propranolol therapy in premature infants|||||||
1402993|NCT01238471|Primary|Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy|"If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome.~Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina."|propranolol therapy for up 4 weeks||||cases|||Number
1402994|NCT01238341|Secondary|Total Procedure Time||During procedure, up to 3 hours||||minutes|Participants|Full Range|Mean
1402995|NCT01238341|Secondary|Successful Endoscopic Therapy||During procedure, up to 3 hours||||ERCPs|Participants||Number
1403003|NCT01238211|Secondary|Event-free Survival|"Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The median EFS with 95% CI was estimated using the Kaplan-Meier method,~Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts)."|Up to 10 years|||||||
1403004|NCT01238211|Primary|30 Day Survival Rate|Percentage of participants who were alive 30 days after starting induction treatment.|30 days||||percentage of participants||95% Confidence Interval|Number
1403005|NCT01237678|Secondary|Overall Survival (OS) Rate at 12 Months|OS was analyzed based on a binary definition of the number of patients dead or censored prior to 12 months and the number of patients alive at 12 months. The primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates. The control arm was primarily planned to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed. Further, the trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to OS and no determination of the OS rate at 12 months for the control arm was performed; therefore only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented.|12 months|A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.|||percentage of participants alive||95% Confidence Interval|Number
1403006|NCT01237678|Secondary|Median Overall Survival (OS) in Phase II|A secondary outcome measure for Phase II was to determine the overall survival of patients treated with IMGN901 in combination with carboplatin/etoposide chemotherapy versus carboplatin/etoposide chemotherapy alone as first-line treatment for patients with extensive stage small cell lung cancer.|From the time of enrollment until death on study due to any cause (up to post-treatment follow-up 28 days after last dose, up to 22 months)|A total of 121 patents were included in the analyses (82 in Arm1 and 39 in Arm 2) due to due to the lack of post-baseline evaluations for 20 participants.|||months||95% Confidence Interval|Median
1403007|NCT01237678|Secondary|Progression Free Survival (PFS) Rate at 6 Months|The trial was not empowered to permit a statistically informative comparison of the randomized treatment groups with respect to PFS. The activity of IMGN901 was assessed by comparing the PFS rate at 6 months in the IMGN901 experimental arm against the historical 6-month PFS rate of 0.44 (equivalently a median PFS = 5 months). Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the objective was to compare PFS at 6 months in the experimental arm (triplet combination) against the historical PFS rate of 0.44 (equivalently a median PFS = 5 months) for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.|6 months|A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.|||percentage of participants||95% Confidence Interval|Number
1403008|NCT01237678|Secondary|Overview of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|To assess the type and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). An AE was defined as any noxious, pathologic, or unintended change un anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of the study, whether or not deemed study drug-related. An SAE was any AE resulting in death, life-threatening experience, initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, or congenital defect. All AEs were reported from the time of the first dose of study treatment until 28 days after the final dose of study drug. the severity of AEs were graded by the Investigator using National cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 4.0.|From the first dose of study drug on Cycle 1, Day 1 until 28 days after the last study treatment (up to 22 months)||||participants|||Number
1403009|NCT01237678|Primary|Maximum Tolerated Dose (MTD) of IMGN901|A primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. The MTD was determined based on DLTs that occurred during Cycle 1.|21 days (Cycle 1)|During escalation, carboplatin dosing was reduced from AUC 6 to AUC 5 due to poor tolerability; therefore the MTD for IMGN901 was determined in combination with carboplatin AUC5 and 100 mg/m^2 etoposide|||mg/m^2|||Number
1403010|NCT01237678|Primary|Progression Free Survival (PFS) in Phase II|The primary outcome measure for Phase II was to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy as first-line treatment for patients with extensive stage small cell lung cancer. PFS was defined as the time from enrollment until objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. Only the results from the experimental arm (IMGN901 + carboplatin + etoposide) are presented as the primary objective of this phase of the study was to compare PFS in the experimental arm (triplet combination) against historical PFS rates for carboplatin and etoposide. The control arm was planned primarily to reliably assess the safety of IMGN901 and to demonstrate whether the or not the historical assumptions regarding efficacy were confirmed.|From randomization to objective tumor progression or death (up to post-treatment follow-up 28 days after last dose, up to 22 months)|A total of 82 patients from the IMGN901 + carboplatin + etoposide safety population (N=94) were included in the efficacy analyses, due to the lack of post-baseline evaluations for 12 participants.|||months||95% Confidence Interval|Median
1403035|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)|"Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-parent measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403011|NCT01237678|Primary|Occurrence of Dose Limiting Toxicities (DLT)|The primary outcome measure for Phase I was to determine the maximum tolerated dose (MTD) and characterize the dose limiting toxicities (DLT) of IMGN901 when administered in combination with carboplatin/etoposide chemotherapy followed by IMGN901 alone in patients with solid tumors. For the purposes of dose escalation and determination of MTD, DLTs were defined as AEs or abnormal laboratory values related to study treatment which occurred in Cycle 1 of the Dose Escalation phase, including any AEs that resulted in failure to meet the criteria for re-treatment. The following events were considered DLTs (using the most current version of CTCAE): febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding; ≥ Grade 3 peripheral neuropathy; ≥ Grade 3 vomiting, nausea, or diarrhea that persisted despite the use of optimal therapy; other ≥ grade 3 non-hematologic toxicity (with the exception of brief fatigue i.e. ≤ 72 hours and alopecia)|21 days (Cycle 1)|A total of 33 patients were analyzed as part of the Dose escalation phase.|||participants|||Number
1403012|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403013|NCT01237613|Secondary|Return to Work and Previous Physical Activities||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403014|NCT01237613|Secondary|Subjective Evaluation of Treatment||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403015|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403016|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403017|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403018|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403019|NCT01237613|Secondary|Return to Work and Previous Physical Activities||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403020|NCT01237613|Secondary|Subjective Evaluation of Treatment||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403021|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403022|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403023|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403024|NCT01237613|Secondary|Clinical Evaluation Including Adverse Events||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403025|NCT01237613|Secondary|Return to Work and Previous Physical Activities||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403026|NCT01237613|Secondary|Subjective Evaluation of Treatment||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403027|NCT01237613|Secondary|Range of Motion, Strength and Calf Circumference||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403028|NCT01237613|Secondary|General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403029|NCT01237613|Secondary|The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403030|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||12 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403031|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||6 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403032|NCT01237613|Primary|The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability||3 months|Data not analyzed as study was terminated due to sponsor bankruptcy.||||||
1403033|NCT01237587|Secondary|Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline MASC measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403034|NCT01237587|Secondary|Change From Baseline in Children's Depression Inventory (CDI)|"Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CDI measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403036|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Child Form (FDI-child)|"Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-child measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403037|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score|"Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI mental Illness measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403038|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score|"Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI overall illness measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403039|NCT01237587|Secondary|Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores|"Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for pain now, worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline PPQ measurement.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403040|NCT01237587|Secondary|Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items|"The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value."|Baseline (extension phase), 39 weeks|"All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline BPI severity & interferences items scores.~Baseline for extension phase is defined as the last non-missing value in acute phase."|||units on a scale||Standard Error|Least Squares Mean
1403041|NCT01237587|Secondary|Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.|Baseline, 13 weeks|"All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline MASC score.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|||units on a scale||Standard Error|Least Squares Mean
1403042|NCT01237587|Secondary|Change From Baseline in Children's Depression Inventory (CDI)|"Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CDI score.|||units on a scale||Standard Error|Least Squares Mean
1403043|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)|"Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI-parent scale score.|||units on a scale||Standard Error|Least Squares Mean
1403044|NCT01237587|Secondary|Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)|"Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI child scale score.|||units on a scale||Standard Error|Least Squares Mean
1403045|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score|"Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S mental illness score.|||units on a scale||Standard Error|Least Squares Mean
1403046|NCT01237587|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score|"Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S overall illness score.|||units on a scale||Standard Error|Least Squares Mean
1403047|NCT01237587|Secondary|Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores|"Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for “pain now,” worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline PPQ score.|||mm||Standard Error|Least Squares Mean
1403048|NCT01237587|Secondary|Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF)."|13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.|||Participants|||Count of Participants
1403049|NCT01237587|Secondary|Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF)."|13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.|||Participants|||Count of Participants
1403050|NCT01237587|Secondary|Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase."|Baseline (Extension Phase), 39 weeks|All randomized participants in duloxetine only arm with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.|||units on a scale||Standard Deviation|Mean
1403063|NCT01237327|Secondary|Duration of Response (DR)|Duration of objective response (complete response [CR] or partial response [PR]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response.|Every 12 weeks up to 6 years|ITT.|||months||95% Confidence Interval|Median
1403064|NCT01237327|Secondary|Objective Response Rate (ORR)|Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group|Every 12 weeks up to 6 years|ITT|||percentage of participants|||Number
1403051|NCT01237587|Secondary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items|"The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.~MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI severity & interferences items score.|||units on a scale||Standard Error|Least Squares Mean
1403052|NCT01237587|Primary|Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item|"Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.~Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means."|Baseline, 13 weeks|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.|||units on a scale||Standard Error|Least Squares Mean
1403053|NCT01237353|Secondary|Duration of Gastric pH Status|When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours|2 hours after dose of betaine HCl||||minutes||Standard Deviation|Mean
1403054|NCT01237353|Primary|Change in Gastric pH After Administration of Betaine Hydrochloride (HCl)|Gastric pH levels monitored with a Heidelberg pH capsule (HC) which sends real-time signals to a computer system that visually plots intestinal pH on a minute-by-minute basis. When subject's pH remained above 4.0 for at least 15 minutes, a 1500 mg dose of betaine HCl was given orally with 90 mL of water, and gastric pH was continuously monitored for 2 hours.|30 minutes||||units on a scale||Standard Deviation|Mean
1403055|NCT01237340|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection).|Day 1 up to 28 days after last dose of study treatment|Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment.|||participants|||Number
1403056|NCT01237340|Secondary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||nmol/L||Standard Deviation|Mean
1403057|NCT01237340|Secondary|Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)|Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.|Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."|||standard deviation score||Standard Deviation|Mean
1403058|NCT01237340|Secondary|Insulin-like Growth Factor-I (IGF-1) Levels||Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26|"Safety population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline safety assessment. ‘N’ (number of participants analyzed) = participants who were evaluated for this measure and n= participants who were analyzed at that particular time point for each arm group respectively."|||nanomole per liter (nmol/L)||Standard Deviation|Mean
1403059|NCT01237340|Secondary|Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®|Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.|Baseline up to Week 26|MITT population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.|||participants|||Number
1403060|NCT01237340|Primary|Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®|Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.|Baseline up to Week 26|Modified Intent-to-Treat (MITT) population consisted of all the participants who received at least 1 dose of study medication and had at least one post-baseline BAbs assessment.|||participants|||Number
1403061|NCT01237327|Secondary|Time to Treatment Failure (TTF)|TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event.|Every 12 weeks up to 6 years|ITT|||months||95% Confidence Interval|Median
1403062|NCT01237327|Secondary|Time to Tumor Progression (TTP)|TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions.|Every 12 weeks up to 6 years|ITT|||months||95% Confidence Interval|Median
1403065|NCT01237327|Primary|Overall Survival|Overall survival in months measured from date of starting treatment in core study to date of death for any reason.|Every 12 weeks up to 6 years|Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study.|||months||95% Confidence Interval|Median
1403066|NCT01237301|Secondary|The Secondary Objective is to Determine the Incremental Benefit of CGM for Clinical Decision-making.|"Outcome will be measured by:~i. HbA1c ii. Glucose exposure (area under the diurnal median curve) iii. Glucose variability (inter-quartile range) iv. Glucose stability (hourly change in the median curve) v. Incidence of hypoglycemia (degree, duration, frequency)"|16 weeks|||||||
1403067|NCT01237301|Primary|Percentage Change in Hemoglobin A1c||2 week baseline to 18 week final|Per Protocol|||percentage of HbA1c||Standard Deviation|Mean
1403068|NCT01237223|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.|8 weeks|Safety set: All patients who received at least one dose of double-blind study medication.|||Participants|||Number
1403069|NCT01237223|Secondary|Percentage of Participants Achieving a Successful Response Rate|The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication|||percentage of participants|||Number
1403070|NCT01237223|Secondary|Percentage of Participants Achieving Blood Pressure Control at Endpoint|Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.|8 weeks|Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication|||percentage of participants|||Number
1403071|NCT01237223|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.|||mm Hg||Standard Error|Least Squares Mean
1403072|NCT01237223|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)|Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.|Baseline, Week 8|Full analysis set (FAS): All randomized patients received at least one dose of double-blind study medication.|||mm Hg||Standard Error|Least Squares Mean
1403073|NCT01237197|Primary|Percent Change From Baseline in Body Mass Index at 3-months|As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.|Baseline and 3-months||||percentage of change in BMI||Standard Deviation|Mean
1403074|NCT01237080|Primary|Time to Intubate||From when the anaesthetist picked up the GS / FT until a typical capnogram was seen on the capnograph.|The sample size was calculated to 40 in each group (50 patients were included in each group): minimum relevant difference in intubation time of 20 s and a standard deviation of 28 s. A significance level of 0.05 and an acceptable risk of Type 2 error of 0.1 were used.|||sec||95% Confidence Interval|Mean
1403075|NCT01237080|Secondary|Postoperative Throat Pain.||one hour postoperative|||||||
1403076|NCT01237080|Secondary|Postoperative Hoarseness.||one hour postoperative.|||||||
1403077|NCT01237080|Secondary|Intubation of the Esophagus.||detected immediately|||||||
1403078|NCT01237080|Secondary|Subjectively Intubation Difficulty||measured immediately on a visual analogue scale.|||||||
1403079|NCT01237080|Secondary|Mucosal Lesion||inspection during intubation and one hour postop.|||||||
1403080|NCT01237080|Secondary|Lowest Saturation During Intubation.||measured on the monitor|||||||
1403081|NCT01237080|Primary|Number of Patients Intubated in the First Attempt|The intubation attempt was considered a failure if the GS or the FT was removed from the patient’s mouth and required reinsertion or if the cuff had been inflated and the tube needed to be replaced (e.g., in oesophageal intubation).|please see description||||participants|||Number
1403082|NCT01237054|Secondary|Comparison of Microvessel Density (MVD) Between MGUS and SMM/MM Groups|Microvessel density was estimated by determining the average number of CD34-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification).|60 days|Serum was not available for three patients in the SMM group.|||microvessels/hpf||Standard Error|Mean
1403083|NCT01237054|Secondary|Comparison of Serum Angiogenic Marker Reverse Contrast Transfer Rate (Kep) Between MGUS and SMM/MM Groups|Pharmacokinetic parameter Kep was measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).|60 days|Serum was not available for three patients in the SMM group.|||per min||Standard Error|Mean
1403084|NCT01237054|Secondary|Comparison of Reverse Contrast Transfer Rate (Kep) and Forward Contrast Transfer Rate (Ktrans) Among Patients With MGUS, SMM, and MM|Pharmacokinetic parameters Kep and Ktrans were measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).|60 days|Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.|||per min||Full Range|Median
1403085|NCT01237054|Secondary|Comparison of Microvessel Density (MVD) Among Patients With MGUS, SMM, and MM|Microvessel density was estimated by determining the average number of cluster of differentiation 34 (CD34)-stained microvessels in 10 areas of maximal MVD counted at a high-power field (h.p.f. x 500 magnification). Large vessels and vessels in the periosteum on bone were excluded. Areas of staining with no discrete breaks were counted as a single vessel. The presence of a lumen was not required.|60 days|Three patients with MM did not undergo bone marrow biopsies and were not included in this analysis.|||microvessels/hpf||Full Range|Median
1403086|NCT01237054|Secondary|Comparison of Serum Angiogenic Markers Ang2 (Angiopoietin), G-CSF (Granulocyte-colony Stimulating Factor), Follistatin, HGF (Hepatocyte Growth Factor), FGF-1, Endothelin 1, and VEGF-A (Vascular Endothelial Growth Factor-A) Between MGUS and SMM/MM Groups|The assay was performed according to the manufacture's protocol, and all samples were diluted 1:3. Cytokine values were calculated using a five-parameter standard curve with Bio-Plex Manager 6.1.|60 days|Serum was not available for three patients in the SMM group.|||pg/ml||Standard Error|Mean
1403087|NCT01237054|Primary|Count of Participants With Positive DCE-MRI Imaging Results|DCE-MRI, an FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA). The criteria was presence of early and diffuse hyper-enhancement compared to the surrounding bone marrow. The pattern of marrow involvement on MRI was characterized as: (1) normal when there was no evidence of abnormal signal intensity; (2) focal, which consisted of localized areas of abnormal marrow; the lesions are darker than yellow marrow and slightly darker than or isointense to red marrow on T1-weights images; (3) diffuse, in which normal bone marrow signal intensity is completely absent, the intervertebral disks appear brighter than or isointense to the diseased marrow; and finally (4) heterogeneous that consists of innumerable small foci of disease on a background of intact marrow, with small dark lesions on T1-weighted images, which become bright on T2-weighted image.|60 days|Missing means the imaging test was not done. Unclear means it is indeterminate whether an imaging result is positive or negative.|||Participants|||Count of Participants
1403088|NCT01237054|Primary|Count of Participants With Positive and Negative 18F-FDG PET CT and F18-NaF PET CT Imaging Results in Individuals With MGUS, SMM, and MM.|18F-FDG PET CT and F18-NaF PET CT imaging results were compared in participants with MGUS, SMM, and MM. Lesions were considered positive if focal uptake corresponded to lesions identified on CT for NaF and negative if no uptake seen in lesions. Criteria to define FDG positivity included parameters published by Zamagni et al with focal abnormal uptake more intense than background.|60 days||||Participants|||Count of Participants
1403089|NCT01236768|Other Pre-specified|Adhesion at Application Site|"Measurement of adhesion of application site is defined as follows:~0: >=90% adhered (no lifting)~>=75% adhered but <90% (some edges showing lifting)~>=50% adhered but <75% (half of the patch lifts off)~<50% (> half of patch lifts off, but not detached)~patch completely detached"|6 months|Subjects that have documented adhesion scores.|||Score||Standard Deviation|Mean
1403090|NCT01236768|Other Pre-specified|Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)|Measurement of plasma levels of levonorgestrel and ethinyl estradiol.|3 months and 6 months|Number of subjects with available LNG data for cycle 3 or cycle 6|||pg/mL||95% Confidence Interval|Mean
1403091|NCT01236768|Other Pre-specified|Irritation and Itching at Application Site|"AG200-15 irritation and itching scores are defined as follows:~0=none~mild~moderate~severe"|6 months|Subject self-reported worse irritation score in a cycle.|||Score||Standard Deviation|Mean
1403092|NCT01236768|Other Pre-specified|Cycle Control|The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.|6 months|Subjects with relevant breakthrough bleeding (BTB) and/or spotting (BTS), and drug information for a cycle.|||percent cycles with BTB or BTS|||Number
1403093|NCT01236768|Secondary|Safety|Adverse events|6 months|Any subject who applied a patch.|||Events|||Number
1403094|NCT01236768|Primary|Pregnancy Reported as Pearl Index|Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|6 months|Intent-to-treat population ages 18-35.|||Pearl Index||95% Confidence Interval|Number
1403095|NCT01236742|Secondary|Incidence of Adverse Effects|The observation of serious and non-serious adverse events in the 14 months of study period|14 months||||Participants|||Count of Participants
1403096|NCT01236742|Primary|Change in Axial Length|To determine the changes in axial length in the first 7 months and the last 7 months in the three groups of subjects|Baseline, 7 months, and 14 months after baseline||||mm||Standard Deviation|Mean
1403097|NCT01236573|Primary|Response (Complete Response (CR) + Partial Response (PR)) to Therapy|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline um LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions.|4 years||||participants|||Number
1403098|NCT01236573|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|49 months and 20 days||||participants|||Number
1403099|NCT01236573|Primary|Maximum Tolerated Dose (MTD)|The MTD was determined by evaluating dose limiting toxicities (DLT) of participants that received increasing doses of intravenous infusion of IL-12 gene transduced tumor infiltrating lymphocytes (TIL) (i.e., 1x10^6, 3x10^6, 3x10^7, 1x10^7, 3x10^7, 1x10^8, 3x10^8, 1x10^9, and 3x10^9) in cohorts 1-10. Maximum tolerated cell dose is the highest dose at which </= 1 of 6 patients experienced a DLT (i.e. grade 2 or greater allergic reaction)).|4 years||||Cells|||Number
1403100|NCT01236534|Secondary|Number of Participants With Diarrheic Events.|To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients.|21 days|per protocol|||participants|||Number
1403101|NCT01236534|Primary|Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.|Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.|21 days|per protocol|||spontaneous bowel movements||Standard Deviation|Mean
1403102|NCT01236521|Secondary|SF-36 Social Functioning Scale|The SF-36 social functioning scale is a subscale that assesses the self-reported social functioning. It is scored on a 0 to 100 scale with higher scores representing better social functioning.|Baseline||||scores on a scale||Standard Deviation|Mean
1403105|NCT01236521|Secondary|Current Opioid Misuse Measure (COMM)|The COMM (Current Opioid Misuse Measure) is a 17-item instrument designed to monitor misuse and aberrant behaviors in patients prescribed opioids. The scale is scored from 0 (no evidence of opioid misuse or aberrant behaviors) to 64 (strong evidence for opioid misuse and aberrant behaviors)|baseline||||scores on a scale||Standard Deviation|Mean
1403106|NCT01236521|Secondary|AUDIT-C|The AUDIT-C is validated as an effective screening test and diagnostic tool for alcohol misuse in primary care samples. It is scored on 0 to 10 score with higher scores representing alcohol misuse|Baseline||||scores on a scale||Standard Deviation|Mean
1403107|NCT01236521|Secondary|Generalized Anxiety Disorder 7-item (GAD-7) Scale|The GAD-7 is a measure of anxiety. The GAD-7 consists of 7 items that are scored from 0 (no anxiety) to 21 (severe anxiety)|Baseline||||scores on a scale||Standard Deviation|Mean
1403108|NCT01236521|Secondary|Patient Health Questionnaire-9|The Patient Health Questionnaire-9 is used to assess depression severity. It's 9-items that are scored from 0 (no depression) to 27 (severe depression)|Baseline||||scores on a scale||Standard Deviation|Mean
1403109|NCT01236521|Secondary|Roland Morris Disability Scale|The Roland Morris Disability Scale is a 24-item pain-specific measure of physical disability. It provides a score from 0 (no disability) to 24 (high disability)|Baseline||||scores on a scale||Standard Deviation|Mean
1403110|NCT01236521|Secondary|Pain Catastrophizing Scale|The Pain Catastrophizing Scale a 13-item scale that assesses catastrophizing - a pain belief that have been found to be strong predictor of poor treatment response. It is scored from 0 (no catastrophizing) to 52 (severe catastrophizing)|baseline||||scores on a scale||Standard Deviation|Mean
1403111|NCT01236521|Primary|Brief Pain Inventory Pain Interference Scale Score|The Brief Pain Inventory Pain Interference Scale score assesses if pain interferes with 7 common activities. This scale is score 0 (no interference) to 10 (high interference). The 7-items are averaged to give a score.|Baseline and 3, 6, 9, and 12 months|We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.|||scores on a scale||Standard Deviation|Mean
1403112|NCT01236521|Primary|Brief Pain Inventory Pain Intensity Score at Baseline and Each Follow-up Time Point|The Brief Pain Inventory pain intensity score is scored from 0 (no pain) to 10 (worst pain imaginable). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.|Baseline and 3, 6, 9, and 12 months|We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.|||units on a scale||Standard Deviation|Mean
1403113|NCT01236521|Primary|Brief Pain Inventory Total Score at Baseline and Change Score From Baseline at 3, 6, 9, and 12 Months|The Brief Pain Inventory Total Score combines scores from the BPI Pain Intensity subscale and the BPI Pain Interference subscale. This scale provides a total score from 0 (no pain/no pain interference) to 10 (worst pain imaginable/completely interferes). We report below the baseline score on the 0 to 10 scale. At each follow-up time point (3, 6, 9, and 12 months) we report the change from baseline to follow-up. This value was calculated as the baseline score minus the follow-up score.|Baseline and 3, 6, 9, and 12 months|We analyzed those participants with available data. We had more participants at baseline than the follow-up time points at 3, 6, 9, and 12 months due to attrition and no available data among those who dropped out of the study.|||units on a scale||Standard Deviation|Mean
1403114|NCT01236391|Secondary|Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score|Mean change from baseline to Cycle 5 in the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) Global Health Status Score according to EORTC QLQ-C30 Scoring Manual (3rd Edition, 2001). For global health status, positive changes indicated better health status or functioning, and negative changes indicated worsening of health status or functioning. Scale scores range from 0 to 100. A change in 5 to 10 points in either direction represents a small change; 10 to 20 points represents a moderate change and greater than 20 points represents a large change.|From Baseline to Cycle 5 (Week 20)||||scores on a scale||Standard Deviation|Mean
1403115|NCT01236391|Secondary|PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765|Area under the plasma concentration-time curve using data collected at 0, 1, 2, 4, 6-8, and 24 hours post dose (AUC0-24h)|Performed During the First Month of Receiving PCI-32765|PK samples were collected in a subset of participants (n=48) in this trial (n=111). PK parameters reported here reflects those that were PK evaluable from the 48 participants.|||AUC0-24h (ng*h/mL)||Standard Deviation|Mean
1403116|NCT01236391|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure||||participants|||Number
1403117|NCT01236391|Primary|Percentage of Participants Achieving Response|The primary endpoint of the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR) or partial response (PR), according to the revised International Working Group Criteria for non-Hodgkin’s lymphoma (Cheson et al, 2007), as assessed by the investigator. CR is a complete disappearance of all disease, no new lesions, lymph nodes must have regressed and be PET negative, spleen and liver should not be palpable and without nodules, and bone marrow must be negative. PR is a >/= 50% decrease in the sum of the product of diameters of the target lesions, and >/= 50% decrease of splenic and hepatic nodules from baseline, no new lesions and no increase in the size of liver, spleen or non-target lesions.|The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population|||percentage of participants with response||95% Confidence Interval|Number
1403136|NCT01236339|Secondary|Time to Transplant|"Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant.~*Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination."|Through 24 months||||participants|||Number
1403137|NCT01236339|Secondary|Overall Survival|"Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. >~*Note: Outcome measure entered below is number of subjects alive at time of study termination."|Through 24 months||||participants|||Number
1403118|NCT01236378|Secondary|Number of Participants With Estimated Glomerular Filtration Rate (GFR) Less Than (<) 60 mL/Min/1.73 m^2|GFR, an index of kidney function, describes flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. GFR was calculated using the Simplified Modification of Diet in Renal Dysfunction (MDRD) GFR equation. Normal GFR is >90 mL/min/1.73 m^2; children and older people usually have lower GFR. Often, kidney transplant recipients do not have normal GFRs. Lower values indicate poor kidney function. GFR <15 mL/min/1.73 m^2 is consistent with kidney failure. For this posting, the number of subjects with a GFR <60 mL/min/1.73 m^2 is listed.|From baseline up to Day 4|All participants.|||participants|||Number
1403119|NCT01236378|Secondary|Number of Participants With Serum Creatinine Levels More Than (>) 1.3 Times the Upper Limit of Normal|Serum creatinine, an indicator of kidney function, formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue, is removed from blood by kidneys and excreted in urine. Increased creatinine in blood indicates decreased kidney function. Creatinine levels are age, gender and race dependent as they are related to an individual’s muscle mass. Renal transplant recipients may have elevated serum creatinine. For this study an abnormal serum creatinine level is defined as 1.3 times the upper limit of normal (ULN) for the laboratory where the determination was performed.|From baseline up to Day 4|All participants.|||participants|||Number
1403120|NCT01236378|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||liter per hour (L/h)||Standard Deviation|Mean
1403121|NCT01236378|Primary|Degree of Fluctuation (DF)|DF, also known as peak to trough fluctuation (PTF) (calculated as [Cmax minus Ctrough] divided by Cave), is a unit-less ratio of the Cmax to Ctrough decrease expressed as a fraction of the average concentration during a dosing interval.|Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||ratio||Standard Deviation|Mean
1403122|NCT01236378|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1403123|NCT01236378|Primary|Average Blood Concentration at Steady State (Cave,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||ng/mL||Standard Deviation|Mean
1403124|NCT01236378|Primary|Observed Blood Trough Concentration at Steady State (Ctrough,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||ng/mL||Standard Deviation|Mean
1403125|NCT01236378|Primary|Time to Reach Maximum Observed Blood Concentration at Steady State (Tmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK Parameter Analysis Population|||hours||Full Range|Median
1403126|NCT01236378|Primary|Maximum Observed Blood Concentration at Steady State (Cmax,ss)||Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours post dose|PK parameter analysis population: All treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1403127|NCT01236365|Primary|Hs-CRP Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM decreases the concentration of inflammatory markers.|Randomization and 6 months||||mg/dL||Inter-Quartile Range|Median
1403128|NCT01236365|Secondary|Subclinical Atherosclerosis and Vascular Stiffness With the Use of Abdominal Aortic MRI.|T1DM patients will have an MRI scan of the abdominal aorta using an image acquisition protocol to measure subclinical atherosclerosis and arterial stiffness. Subjects will be rescanned at the conclusion of the 6 month trial. A group of healthy, non diabetic age-matched controls will be scanned as well.|6 months|||||||
1403129|NCT01236365|Secondary|Gene Expression and Concentration of Key Molecules That Participate in the Inflammatory Process and Arterial Plaque Formation.|We will restrict participation in protocol #2 to those with T1DM for >3 years and a HbA1C >8% using a stratified balanced randomization. Blood will be withdrawn for a special genetic test. Age-matched, non-diabetic healthy controls will be recruited for comparison.|6 months|||||||
1403130|NCT01236365|Secondary|Relationship Between Glycemic Variability- Measured by the Mean Amplitude of Glycemic Excursion With Continuous Glucose Monitoring.|At randomization, 3 and 6 months a CGM (IPro®, Medtronic Minimed) will be worn blindly for 6d to assess glucose variability to correlate mean amplitude of glycemic excursions (MAGE) with changes in Lp particles and hsCRP.|Randomization and 6 months|||||||
1403131|NCT01236365|Primary|LDL-C Levels Assessed at Randomization and 6 Months|To assess if the use of statins in children with type 1 DM is safe, improves measures of LDL-C. Subjects will have a physical exam, laboratories, nutritional counseling and moderate aerobic exercise recommended. Diabetes management will be intensified. At 3 months fasting lipoprotein fractions (ion mobility)re-drawn and if LDL-C >100mg/dl patients will be randomized to treatment with statins or placebo for 6 months, randomization stratified by BP and microalbuminuria, duration of diabetes and HgA1C. At 1 month safety labs will be repeated and blood withdrawn again at 3 and 6 months from baseline.|Randomization and 6 months|Adjusted for age, gender and ISS (Insulin sensitivity score)|||mg/dL||Standard Error|Mean
1403132|NCT01236339|Secondary|Liver Disease Complications (Adverse Events)|Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding.|Through 24 months||||participants|||Number
1403133|NCT01236339|Secondary|Procedural Success|"Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein~*Note: Control (LVP) arm includes only subjects who crossed over to TIPS"|Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)||||participants|||Number
1403134|NCT01236339|Secondary|Frequency of Hepatic Encephalopathy|Number of episodes of West Haven grade 2 or greater|Through 24 months||||Number of episodes|||Number
1403138|NCT01236339|Primary|Transplant-free Survival|"Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up.~Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination."|Through 24 months||||participants|||Number
1403139|NCT01236326|Secondary|Recovered by 2 Months After Donation||2 months||||participants|||Number
1403140|NCT01236326|Secondary|Days to Normal Day-to-day Activities||2 months||||days||Standard Deviation|Mean
1403141|NCT01236326|Secondary|Days Before Going Back to Work||2 months||||days||Standard Deviation|Mean
1403142|NCT01236326|Secondary|Days on Oral Pain Medication After Discharge||2 months||||days||Standard Deviation|Mean
1403143|NCT01236326|Primary|The Primary End Point of the Study Was the Mean/Median Number of Days Postsurgery Required for Each Group to Return to 100% Functioning Capacity.|"The Primary Endpoint of the Study Will be Patient Self-reported Return to 100%, as Measured by the Number of Days Post-surgery That the Patient Reports His or Her Return to 100% Functioning Capacity."|1 year||||days||Standard Deviation|Mean
1403144|NCT01236300|Primary|NPV (Negative Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
1403145|NCT01236300|Primary|PPV (Positive Predictive Value)|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
1403146|NCT01236300|Primary|Specificity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
1403147|NCT01236300|Secondary|Overall Complication Rate|Assess the safety of nCLE, by recording any possible adverse event or complications occurring during or shortly after the EUSFNA and nCLE procedure|August 2011||||percentage of participants||95% Confidence Interval|Number
1403148|NCT01236300|Primary|Sensitivity|"Using the descriptive criteria of the nCLE images of mucinous vs. non mucinous cysts determined in stage 1, we assessed diagnostic parameters of needle-based confocal laser endomicroscopy of for the detection of pancreatic cystic neoplasia in stage 2.~For patients who underwent surgery, a gold standard diagnosis was obtained by histopathological diagnosis of the surgical specimen. The local pathologist reviewed the histology slides and selected key areas for high-resolution digital photography. Digital images for all surgical cases were sent to the central pathologist (J.H.) for review.~In patients who did not undergo surgery, the final diagnosis was established by clinical diagnosis after a review by five investigators. These investigators independently reviewed the patients’ clinical factors, cross-sectional image findings, EUS findings and images, and cyst fluid results, and follow-up imaging studies ranging from 10 to 22 months, if available."|October 2011|Among 66 patients, 26 patients who categorized in Stage 1 only used to develop terms for specific findings, 8 patients were excluded due to insufficient information available to make a consensus diagnosis, and 31 patients in Stage 2 were analyzed.|||percentage of participants||95% Confidence Interval|Number
1403149|NCT01236196|Primary|Pain Intensity|Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1403150|NCT01236196|Primary|Pain Behavior|Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior|Baseline, 46 weeks|OEF/OIF/OND military veterans with chronic pain|||units on a scale||Standard Deviation|Mean
1403154|NCT01236170|Secondary|Participation in Society|"We assessed participation in society with a modified version of the Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF). The CHART was designed to provide a simple measure of involvement in life situations (“In a typical week, how many days do you get out of your house and go somewhere?”) with sub-scales measuring physical independence, cognitive independence, mobility, occupation, social integration and economic self-sufficiency. The CHART-SF produces scores ranging from 0 (severe handicap) to 100 (no handicap) for each of the sub-scales and a total score ranging from 0-600. The CHART-SF is the most widely used participation measure in rehabilitation research. It has been used in various ethnic groups, and has well-established psychometric properties (test-retest reliability = .93; inter-rater reliability = .83). We dichotomized into Disabled and Not Disabled where disabled are those with a CHART score <100, and not disabled are those with a CHART score >=100"|Measured at baseline|452/482 participants were included in this analysis because 30 participants had missing data.|||participants|||Number
1403155|NCT01236170|Secondary|Satisfaction With Prescribed Wheelchair|We assessed Satisfaction with patients’ prescribe wheelchair using the Quebec User Evaluation of Satisfaction with assistive Technology ( (QUEST). We used an 8-item subset of the QUEST to assess patients’ satisfaction with their wheelchair. QUEST is the first and only standardized satisfaction assessment tool that was designed specifically for assistive technology devices. Its’ development was based on major theoretical models of assistive technology. The QUEST has been widely cited and used in clinical and research settings, and demonstrates strong psychometric properties (Cronbach’s alpha = .82). The 8 item subset focuses specifically on patients’ satisfaction with different aspects of their wheelchair (e.g., “How satisfied are you with the dimensions (size, height, length, width) of your assistive device?”). Responses range from 1(not satisfied at all) to 5(very satisfied). Cronbach’s alpha = .80 for the 8-item wheelchair subset. We chose to eliminate the other four items|one time use, at baseline||||units on a scale||Standard Deviation|Mean
1403156|NCT01236170|Secondary|Satisfaction With Wheelchair Service Delivery|We assessed Satisfaction with Wheelchair Service Delivery using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily administered and scored measure of client satisfaction with services (e.g., “How would you rate the quality of service you have received?”). For the purpose of this study, we asked patients to focus specifically on satisfaction with service at their SCI or AL wheelchair clinic. The scale is unidimensional, yielding a homogenous estimate of general satisfaction with services. It is scored by summing the individual items and produces a score ranging from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has been extensively used in a variety of healthcare settings, operates similarly across ethnic groups, and demonstrates excellent psychometric properties (Cronbach’s alpha = .83-.93).|one time use, at baseline||||units on a scale||Standard Deviation|Mean
1403157|NCT01236170|Primary|Quality of Life|We will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12)and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach’s alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. We assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).|Measured at baseline|Only 468/482 participants were included in this analysis due to 14 participants having missing data.|||units on a scale||Standard Deviation|Mean
1403158|NCT01236118|Primary|Number of Participants With Adverse Events (AEs) [Clinically Significant Events]|Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.|Baseline through study completion (up to Week 56)|All enrolled participants.|||participants|||Number
1403159|NCT01236105|Secondary|Time to Maximum Plasma Concentration (Tmax) for LY2624803 and the Metabolite, LSN2797276|Tmax, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.|||hours (h)||Full Range|Median
1403160|NCT01236105|Primary|Maximum Concentration (Cmax) for LY2624803 and the Metabolite, LSN2797276,|Cmax estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1403161|NCT01236105|Primary|Area Under the Concentration-Time Curve (AUC) for LY2624803 and the Metabolite LSN2797276|AUC from time 0, extrapolated to infinity, estimated for both LY2624803 and the metabolite LSN2797276.|Predose and up to Day 4|All participants who received at least 1 dose of LY2624803 and have evaluable pharmacokinetic (PK) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1403162|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403455|NCT01233999|Primary|Mean Digital Temperature Difference From Baseline|Each digit temperature was measured and recorded at baseline, and then measured and re-recorded after 3 minute intervals following a 20 second 4 degree Celsius ice bath immersion.|6 weeks||||Celsius||95% Confidence Interval|Mean
1403163|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403164|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403165|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403166|NCT01236053|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403167|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403168|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403246|NCT01235910|Primary|Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC)|The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.|7 days, 14 days, 30 days (End of Study)||||ng*h/ml/mg|||Number
1403169|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403170|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403171|NCT01236053|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403172|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403173|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403174|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1404219|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Threshold|RV pacing threshold results were reported at pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge|||volts (V)||Standard Deviation|Mean
1403175|NCT01236053|Primary|Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was same as for case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403176|NCT01236053|Primary|Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was the same as case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403177|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403178|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403179|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403180|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403181|NCT01236053|Primary|Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403182|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403183|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403184|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403185|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR/95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403186|NCT01236053|Primary|Number of Penile Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403256|NCT01235741|Primary|Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin|In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.|Baseline to Month 6 Follow-Up||||participants|||Number
1403187|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403188|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403189|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403190|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403191|NCT01236053|Primary|Number of Breast Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403192|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403269|NCT01235715|Primary|Units of Homologous Transfusion Over the Course of the Hospital Stay|Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|three days postoperatively|All patients who completed the study were included in analysis.|||units||Standard Deviation|Median
1403193|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403194|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403195|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403196|NCT01236053|Primary|Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level.|The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403197|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403198|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403270|NCT01235715|Primary|Number of Autologous Transfusion Units Over the Course of the Hospital Stay|Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.|perioperatively||||units||Standard Error|Mean
1403199|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403200|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403201|NCT01236053|Primary|Number of Lung Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403202|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403203|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403204|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57 -105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403271|NCT01235715|Primary|Drain Output|A measurement of the amount of blood drained from the knee.|24 hours post-operatively|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||mL||Standard Error|Mean
1403205|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403206|NCT01236053|Primary|Number of Anal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident Anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403207|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403208|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403209|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.3-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 m.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403210|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip]), T 2 (3-7 prescrip), T 3 (8-298 prescrip). Tertiles without 2 yr lag: T 1 (1-2 prescrip), T 2 (3-7 prescrip), and T 3 (8-388 prescrip). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1404220|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Threshold|RV pacing threshold results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant.|||volts (V)||Standard Deviation|Mean
1403211|NCT01236053|Primary|Number of Stomach Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date.|The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403212|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile’s without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403213|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date.|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403214|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403215|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403216|NCT01236053|Primary|Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incidence of all cancers. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases & controls drawn from the GPRD study cohort. Entry into study cohort began January 1, 1993, or at time of GPRD registration if after Jan. 1, 1993. Follow-up ended December 31, 2008, or earlier if respective cancer was diagnosed or if participant left the GPRD for any reason including death. Participants with prior history of cancer excluded.|||participants|||Number
1403217|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason|6 months|Of the 192 subjects in the Safety Set (SS), 168 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.|||percentage of participants|||Number
1403218|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months|Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.|3 months|Of the 192 subjects in the Safety Set (SS), 152 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.|||percentage of participants|||Number
1403219|NCT01236001|Secondary|Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.~Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.|||percentage of participants|||Number
1403220|NCT01236001|Secondary|Treatment Persistence of VIMPAT® After 6 Months|Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (>=6 months).|>=6 months|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.|||percentage of participants|||Number
1403221|NCT01236001|Secondary|Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment|Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.|From baseline to study termination (6 months)|Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.|||percentage of patients|||Number
1403222|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.|||participants|||Number
1403223|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months|VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.|3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.|||participants|||Number
1403224|NCT01236001|Primary|Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline|"This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.~VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation."|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.|||participants|||Number
1403225|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 6 Months||6 months|Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.|||mg/day of Vimpat||Standard Deviation|Mean
1403226|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at 3 Months||3 months|Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.|||mg/day of Vimpat||Standard Deviation|Mean
1403227|NCT01236001|Primary|Mean Total Daily Dose of VIMPAT® (mg) at Baseline|Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.|Baseline|Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.|||mg/day of Vimpat||Standard Deviation|Mean
1403228|NCT01235975|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCI)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
1403229|NCT01235975|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
1403230|NCT01235975|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0 to 30) after vaccination|The primary analysis was performed on the Total Vaccinated cohort (TVC), which cohort included all subjects with vaccine administration documented.|||Participants|||Count of Participants
1403231|NCT01235975|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|Within 4 days (Day 0 to 3) post-vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
1403272|NCT01235715|Primary|Change in Hematocrit on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||percentage of red blood cell||Standard Deviation|Mean
1403232|NCT01235975|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|Within 4 days (Day 0 to 3) post-vaccination|The primary analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
1403233|NCT01235975|Secondary|Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1403234|NCT01235975|Secondary|Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1403235|NCT01235975|Secondary|Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).|At Day 0 and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.|||μg/mL||95% Confidence Interval|Geometric Mean
1403236|NCT01235975|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).|At Day 0 and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.|||Participants|||Count of Participants
1403237|NCT01235975|Secondary|Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value|The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).|At Day 0 and Month 1|The primary analysis was performed on a subset of of the 2 treatment groups and 2 age strata of the According-to-protocol (ATP) cohort for immunogenicity, 50% of subjects were tested for anti-PSA and anti-PSC and the other 50% of subjects were tested for anti-PSW-135 and anti-PSY.|||Participants|||Count of Participants
1403238|NCT01235975|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1403239|NCT01235975|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1403240|NCT01235975|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Day 0 and Month 1|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1403241|NCT01235975|Primary|Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)|Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.|One month after vaccination (Month 1)|The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1403242|NCT01235923|Primary|Reticulocyte Count|reticulocyte count at 4 weeks (end of study)|4 weeks|Power analysis based on difference in mean retic count (baseline versus 4 weeks) of 75 (standard deviation 50), alpha 0.05, 80% power.|||cells x 1000/microliter||Standard Error|Mean
1403243|NCT01235923|Primary|Baseline Retic Count|retic count measured at study entry|baseline|All study subjects had baseline retic count measured.|||x1000 cells/microliter||Standard Error|Mean
1403244|NCT01235910|Secondary|Blood Pressure|The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any blood pressure for this study.|2 weeks||||mmHg|||Number
1403245|NCT01235910|Secondary|Aliskiren Plasma Concentrations|"Maximum plasma concentration; area under the concentration-time curve, half-life, oral clearance~The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any PK (e.g.(AUCs) for this study."|2 weeks||||ng*h/ml/mg|||Number
1403247|NCT01235897|Secondary|Best Disease Response by Response Evaluation Criteria in Solid Tumor (RECIST), Version 1.1|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD): Neither sufﬁcient shrinkage to qualify for PR nor sufﬁcient increase to qualify for PD, taking as reference the smallest sum diameters while on study~Non-PR/Non-PD: clinical response of chest wall disease not evaluable by RECIST"|60 days after dose inititation|Analysis included all patients receiving at least 8 weeks of study therapy|||participants|||Number
1403248|NCT01235897|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of MK-2206 Administered Weekly in Combination With Weekly Paclitaxel 80 mg/m^2 and Trastuzumab 2 mg/m^2|The MTD was defined as the dose level resulting in 3 or fewer DLTs in 11 patients, per the modified toxicity probability interval (TPI) method (Ji Y, Li Y, Nebiyou Bekele B: Dose-ﬁnding in phase I clinical trials based on toxicity probability intervals. Clin Trials 4:235-244, 2007), and confirmed in 4 additional patients. Based on interim toxicity data from other studies, the dose was not escalated beyond 135 mg weekly.|30 days from initiation of dose|Sixteen participants completed at least one cycle of therapy and were evaluable for DLT per protocol. Patients were assessed for DLT during the first 4-week cycle.|||mg|||Number
1403249|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.|||mg/dL||Standard Deviation|Mean
1403250|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.|||mU/L||Standard Deviation|Mean
1403251|NCT01235741|Primary|Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).|Baseline to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement up to Month 6 Follow-Up.|||mg/dL||Standard Deviation|Mean
1403252|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement.|||beats/min||Standard Deviation|Mean
1403253|NCT01235741|Primary|Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).|Baseline to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of drug treatment. The number analyzed in the ITT included those participants who provided a vital sign measurement up to 6 Months follow-up.|||mmHg||Standard Deviation|Mean
1403254|NCT01235741|Primary|Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L; bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.|Screening to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a laboratory measurement.|||participants|||Number
1403255|NCT01235741|Primary|Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population|Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large.|Screening to 6 Month Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. Number analyzed (n) in ITT included participants who provided a laboratory measurement. Hemoglobin, hematocrit n=27, 29 in placebo and pramlintide + metreleptin, respectively; urinalysis n=31, 29, in placebo and pramlintide + metreleptin, respectively.|||participants|||Number
1403257|NCT01235741|Primary|Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population|Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.|Week 1 to Month 6 Follow-Up|All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28.|||participants|||Number
1403258|NCT01235741|Primary|Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population|Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).|Baseline to Month 6 Follow Up|All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively.|||ng/mL||Standard Deviation|Mean
1403259|NCT01235741|Primary|Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population|Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.|Day 1 up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment.|||participants|||Number
1403260|NCT01235741|Secondary|Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population|Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.|Baseline up to Month 6 Follow-Up|The intent to treat (ITT) population received at least one dose of randomized study treatment. The number analyzed in the ITT included those participants who provided a measurement. Number analyzed (n) for Week 1 provided above; 6 Month Follow-Up n=27, 29, in placebo and Pramlintide + Metreleptin, respectively.|||percentage of change in weight||Standard Deviation|Mean
1403261|NCT01235728|Secondary|Mean Maximum Plasma Concentrations at Trough of Day 8, 15, 22, and 29 Following Topical Administration of MK-0873 to Psoriatic Patients|Plasma samples were collected at 12 hours post-dose on Days 8, 15, 22, and 28 to evaluate the mean maximum plasma concentration at trough of MK-0873.|Day 8, 15, 22, 29|The population consisted of all participants that received treatment, had no major protocol violations, and had MK-0873 plasma trough values available for the Day 8, 15, 22, and 28 treatment.|||nM||Standard Deviation|Mean
1403262|NCT01235728|Secondary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of TLS Score for Lesions Treated With MK-0873 and Lesions Treated With Calcitriol|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29|||Percent Change|Lesions|95% Confidence Interval|Least Squares Mean
1403263|NCT01235728|Primary|Least Squares Mean Percent Change From Baseline (Predose Day 1) of Target Lesion Severity (TLS) Score for Lesions Treated With MK-0873 and Lesions Treated With MK-0873 Vehicle|Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using the following scale: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with increasing score reflecting increased lesion severity. The TLS score (range 0 to 12) is calculated as the sum of the 3 components.|Baseline and Day 29|The population consisted of all participants that received treatment, had no major protocol violations, and had TLS scores available at baseline and Day 29.|||Percent Change|Lesions|95% Confidence Interval|Least Squares Mean
1403264|NCT01235715|Secondary|Visual Analog Pain Scale (At Night) At 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.|6 weeks postoperatively||||units on a scale||Standard Deviation|Mean
1403265|NCT01235715|Secondary|Visual Analog Pain Scale (During Therapy) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.|6 weeks postoperatively||||units on a scale||Standard Deviation|Mean
1403266|NCT01235715|Secondary|Visual Analog Pain Scale (During Activity) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.|||units on a scale||Standard Deviation|Mean
1403267|NCT01235715|Secondary|Visual Analog Pain Scale (at Rest) at 6 Weeks|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.|6 weeks postoperatively|Patients whose visual analog pain scale at 6-week followup appointment was taken were included in analysis.|||units on a scale||Standard Deviation|Mean
1403268|NCT01235715|Secondary|Range of Motion at 6 Weeks|A measurement of the degrees of motion of the operated knee six weeks after surgery.|6 weeks postoperatively|Patients whose range of motion at 6-week followup appointment was taken were included in analysis.|||degrees||Standard Deviation|Mean
1403274|NCT01235715|Primary|Change in Hematocrit on Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||percentage of red blood cell||Standard Deviation|Mean
1403275|NCT01235715|Primary|Change in Hemoglobin On Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
1403276|NCT01235715|Primary|Change in Hematocrit on Day 0 Compared to Preoperatively||preoperatively and day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||percentage of red blood cell||Standard Error|Mean
1403277|NCT01235715|Secondary|Visual Analog Pain Scale on Day 3|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.|3 days postoperatively||||points on VAS scale||Standard Error|Mean
1403278|NCT01235715|Secondary|Range of Motion on Day 3|A measurement of the degrees of motion of the operated knee three days after surgery.|3 days postoperatively||||degrees||Standard Error|Mean
1403279|NCT01235715|Secondary|Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively|The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.|preoperatively and two days after surgery|All patients who completed the study were included in analysis.|||ratio||Standard Deviation|Mean
1403280|NCT01235715|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and on the day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
1403281|NCT01235689|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores|"The Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component summary (PCS) score summarizes the subscales physical functioning, role-physical, bodily pain, and general health. The mental component summary (MCS) score summarizes the subscales vitality, social functioning, role-emotional, and mental health. Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement."|Baseline and 48 weeks after Randomization|Randomized participants with Baseline and at least one post-baseline value; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
1403282|NCT01235689|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, from 0 (not at all) to 4 (very much). The FACIT-Fatigue score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from Baseline score indicates an improvement."|Baseline and 48 weeks after Randomization|Randomized participants with Baseline and at least 1 post-baseline value; last observation carried forward imputation was used|||units on a scale||Standard Deviation|Mean
1403283|NCT01235689|Secondary|Change From Baseline in Patient Health Questionnaire - 9 (PHQ9)|The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression. A negative change from Baseline score indicates improvement.|Baseline and 48 weeks after Randomization|Randomized participants with Baseline and at least one post-baseline value; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
1403284|NCT01235689|Secondary|Change From Baseline in Work Productivity Activity Index - Crohn's Disease (WPAI:CD)|"The WPAI:CD questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions.~Work time missed was defined as the percentage of time absent from work due to Crohn’s disease in the past week.~Impairment while working is the participant’s assessment of the degree to which Crohn’s disease affected productivity while working in the past 7 days.~Total work productivity impairment takes into account both hours missed due to Crohn’s disease symptoms and the patient's assessment of the degree to which Crohn’s disease affected their productivity while working.~Total activity impairment is the percent impairment of non-work related activities due to Crohn’s disease.~WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement."|Baseline and 48 weeks after Randomization|Randomized participants with baseline and at least one post-baseline value; last observation carried forward imputation was used. The first 3 scores were only calculated for participants who were employed.|||percent impairment||Standard Deviation|Mean
1403285|NCT01235689|Secondary|Change From Baseline in Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score|The IBDQ measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease, feeling in general, and mood. Each question is answered on a scale from 1 (all of the time) to 7 ( none of the time); the total score ranges from 7 (worst) to 224 (best). A positive change from baseline indicates improvement.|Baseline and 48 weeks after Randomization|Randomized participants with baseline and at least one post-baseline value; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
1403286|NCT01235689|Secondary|Total Dose of Prednisone|The total dose of prednisone each participant received during both the run-in phase and post-randomization treatment phase.|From Baseline through 48 weeks after Randomization|Participants who received prednisone|||mg||Standard Deviation|Mean
1403480|NCT01233817|Primary|Strength|Primary Outcome Measure was muscle strength. Strength was measured using a fixed myometry evaluation, quantitative muscle analysis (QMA). QMA utilizes a relative fixed point for the participant to exert effort. Each muscle of interest was tested using QMA.|12 weeks||||kilograms||95% Confidence Interval|Median
1403287|NCT01235689|Secondary|Change in Fecal Calprotectin From Baseline to 48 Weeks After Randomization|"Stool samples were analyzed by a central laboratory for fecal calprotectin qualitative measurement (< 250 or ≥ 250 μg/g). Results are reported for participants in each category at Baseline and 48 weeks after Randomization.~Participants with missing data 48 weeks after Randomization were counted as having fecal calprotectin ≥ 250µg/g."|Baseline and 48 weeks after Randomization|Randomized participants with Baseline data; non-responder imputation was used.|||Participants|||Count of Participants
1403288|NCT01235689|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Over Time|High sensitivity C-reactive protein was analyzed by a central laboratory.|Baseline and 8 weeks during the prednisone run-in, and 11, 23, 35, and 48 weeks after Randomization.|Randomized participants; last observation carried forward imputation was used.|||mg/L||Standard Deviation|Mean
1403289|NCT01235689|Secondary|Change in Crohn's Disease Behavior According to Montreal Classification|"Participants' Crohn's Disease was classified according to the Montreal Classification which classifies CD according to its predominant phenotypic elements (age at diagnosis, location, and disease behavior) based on the results of clinical examination and endoscopy.~Disease behavior was classified according to the following:~B1 = non-stricturing, non-penetrating; B2 = structuring; B3 = penetrating; P = perianal disease modifier.~The change in Montreal Classification is presented in three categories: no change, deterioration, and improvement. Deterioration was defined as an increase in behavior index between 1 and 3, or development of perianal disease. Participants with missing data at Week 48 were classified as deterioration."|From Baseline to 48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||Participants|||Count of Participants
1403290|NCT01235689|Secondary|Number of Crohn's Disease-related Hospitalizations Due to Emergency|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department.|From Randomization through 48 weeks after Randomization|All randomized participants|||emergency hospitalizations|||Number
1403291|NCT01235689|Secondary|Time to Crohn's Disease-related Hospitalization Due to Emergency|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic. Hospitalization due to emergency was defined as a hospitalization admitted through the emergency department.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
1403292|NCT01235689|Secondary|Number of Crohn's Disease-related Surgical Procedures After Randomization|The total number of CD-related surgical procedures included major CD-related surgery, debridement, perineal related surgery - abscess drainage, seton placement, fistulotomy, and TPN.|From Randomization through 48 weeks after Randomization|All randomized participants|||surgical procedures|||Number
1403293|NCT01235689|Secondary|Total Length of Stay in Hospital for Crohn's Disease-related Hospitalizations||From Randomization through 48 weeks after Randomization|Randomized participants with Crohn's disease-related hospitalizations|||days||Standard Deviation|Mean
1403294|NCT01235689|Secondary|Total Length of Stay in Hospital for All-cause Hospitalizations||From Randomization through 48 weeks after Randomization|Randomized participants with all-cause hospitalizations|||days||Standard Deviation|Mean
1403295|NCT01235689|Secondary|Number of All-cause Hospitalizations After Randomization|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic.|From Randomization through 48 weeks after Randomization|All randomized participants|||hospitalizations|||Number
1403296|NCT01235689|Secondary|Number of Crohn's Disease-related Hospitalizations After Randomization|Any hospitalization with an overnight stay in hospital/clinic related to Crohn's disease.|From Randomization through 48 weeks after Randomization|All randomized participants|||hospitalizations|||Number
1403297|NCT01235689|Secondary|Number of Major Crohn's Disease-related Surgeries After Randomization|"Major Crohn's disease-related intra-abdominal surgery included:~bowel resection~ostomy~by-pass~strictureplasty~drainage of abdominal or pelvic abscess (surgical drainage or percutaneous drainage by interventional radiology).~The following were excluded:~debridement~exploration laparotomy~abdominal surgery for other reason~perineal related surgery~abscess drainage~placement of setons~fistulotomy~Total parental nutrition (TPN) use"|From Randomization through 48 weeks after Randomization|All randomized participants|||surgeries|||Number
1403298|NCT01235689|Secondary|Time to Crohn's Disease-related Hospitalization or Hospitalization Due to Adverse Event Relating to Study Medication|Crohn's disease-related hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic for reasons related to Crohn's disease (CD). Hospitalization for adverse events relating to study medication, i.e., prednisone, azathioprine or adalimumab, were according to Investigator's clinical judgment.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
1403299|NCT01235689|Secondary|Time to All-cause Hospitalization|Hospitalization was defined as a visit to hospital/clinic resulting in admission and overnight stay in hospital/clinic.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
1403300|NCT01235689|Secondary|Percentage of Participants in Steroid-free Remission Over Time|"Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders."|11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.|Randomized participants; non-responder imputation was used. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment.|||percentage of participants|||Number
1403322|NCT01235598|Secondary|C-Reactive Protein (CRP) Ratio to Baseline at Week 16|"The C-Reactive Protein (CRP) is considered a marker of inflammation in subjects with Rheumatoid Arthritis.~A ratio to Baseline < 1 indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1403301|NCT01235689|Secondary|Percentage of Participants in Clinical Remission Over Time|"Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~Participants with missing data at each time point were counted as non-responders."|Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.|Randomized participants; non-responder imputation was used. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment.|||percentage of participants|||Number
1403302|NCT01235689|Secondary|Time to Steroid-free Remission|Steroid-free remission was defined as CDAI < 150 and discontinuation from steroids for at least 8 weeks. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
1403303|NCT01235689|Secondary|Time to Clinical Remission|Clinical remission was defined as CDAI < 150. CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI scores generally range from 0 to 600 where higher scores indicate more severe disease.|From Randomization through 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
1403304|NCT01235689|Secondary|Time to Crohn's Disease Flare|Time to Crohn's disease flare, where flare is defined as an increase in CDAI ≥ 70 points compared to Week 8 or Early Randomization CDAI, and a CDAI > 220.|From Randomization to 48 weeks after Randomization|Randomized participants|||days||Inter-Quartile Range|Median
1403305|NCT01235689|Secondary|Change From Baseline in CDAI Over Time|The Crohn’s Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. A negative change from Baseline indicates improvement.|Baseline and 4 and 8 weeks during the prednisone run-in, and 2, 6, 11, 14, 18, 23, 26, 30, 35, 38, 42, and 48 weeks after Randomization.|Randomized participants with non-missing data at each time point. CDAI was only measured at 14, 18, 26, 30, 38 and 42 weeks after randomization if a participant had initiated a change in treatment.|||units on a scale||Standard Deviation|Mean
1403306|NCT01235689|Secondary|Change From Baseline in CDEIS at 48 Weeks After Randomization|CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. A negative change from Baseline indicates improvement.|Baseline and 48 weeks after Randomization|Randomized participants with non-missing data at Baseline and 48 weeks after Randomization.|||units on a scale||Standard Deviation|Mean
1403307|NCT01235689|Secondary|Percentage of Participants With Endoscopic Response 48 Weeks After Randomization|"Endoscopic response was defined as a decrease CDEIS > 5 points. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
1403308|NCT01235689|Secondary|Percentage of Participants With Complete Mucosal Healing 48 Weeks After Randomization|"Complete mucosal healing was defined as CDEIS = 0. CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
1403309|NCT01235689|Secondary|Percentage of Participants With Mucosal Healing and CDEIS < 4 in Every Segment 48 Weeks After Randomization|"Percentage of participants with mucosal healing (defined as CDEIS < 4) and CDEIS < 4 in every segment on ileocolonoscopy at 48 weeks after randomization. The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
1403356|NCT01235507|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm||Standard Deviation|Mean
1403310|NCT01235689|Secondary|Percentage of Participants With Mucosal Healing 48 Weeks After Randomization|"Percentage of participants with mucosal healing (defined as a CDEIS < 4) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
1403311|NCT01235689|Secondary|Percentage of Participants in Biologic Remission 48 Weeks After Randomization|"Biologic remission was defined as high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, fecal Calprotectin < 250 μg/g, and CDEIS < 4 at 48 weeks after randomization.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing values 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
1403312|NCT01235689|Secondary|Percentage of Participants in Deep Remission 48 Weeks After Randomization|"Deep remission was defined as CDAI < 150, discontinuation from steroids for at least 8 weeks, absence of draining fistula, CDEIS < 4 and no deep ulcerations.~CDAI is a tool used to quantify the symptoms of patients with Crohn's disease. The score includes the frequency of stools, abdominal pain and general well-being as well as the presence of complications, use of antidiarrheals, presence of abdominal mass, hematocrit and weight. CDAI generally ranges from 0 to 600 where higher scores indicate more severe disease.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon. The range of the score is from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; non-responder imputation was used.|||percentage of participants|||Number
1403313|NCT01235689|Primary|Percentage of Participants With Mucosal Healing and No Deep Ulcerations|"Percentage of participants with mucosal healing (defined as Crohn's disease endoscopy Index of severity [CDEIS] < 4) and no deep ulcerations on ileocolonoscopy (defined as the absence of all deep ulcerations in all segments explored in CDEIS) at 48 weeks after randomization (48 weeks after the 1st Key visit). The ileocolonoscopies were evaluated by the site.~CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity.~Participants with missing data 48 weeks after Randomization were counted as non-responders."|48 weeks after Randomization|All randomized participants; Participants with missing CDEIS values from endoscopies performed 48 weeks after randomization were imputed as non-responders.|||percentage of participants|||Number
1403314|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 2 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.~A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1403315|NCT01235598|Secondary|Change From Baseline for the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Synovitis Score at Week 1 Placebo (PBO) Versus Certolizumab Pegol (CZP)|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions (the distal radioulnar; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment.~A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
1403674|NCT01232127|Primary|Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.|||Hours||Full Range|Median
1403316|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Changes in Hand Bone Mineral Density as Measured by Digital XRay (DXR) at Week 16|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with increases in bone mineral density at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
1403317|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With Disease Activity Score-28 (DAS28 (CRP)) Response at Week 16|"The DAS28(CRP) was calculated using the tender joint count (TJC) and swollen joint count (SJC), C-Reactive Protein (CRP in mg/L) and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm).~A positive correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with reductions in DAS28(CRP) at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
1403318|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 70 % Criteria (ACR70) at Week 16|"Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR70 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
1403319|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 50 % Criteria (ACR50) at Week 16|"Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR50 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
1403320|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With American College of Rheumatology 20 % Criteria (ACR20) at Week 16|"Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with an ACR20 response at Week 16."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
1403321|NCT01235598|Secondary|Correlation of Change in Synovitis From Baseline as Measured by Magnetic Resonance Image (MRI) With European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.~Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28(CRP) > 5.1 and decrease from Baseline > 1.2~A negative correlation coefficient indicates that reductions in synovitis from Baseline to Week 16 are associated with better EULAR responses."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication. Correlations between the change from Baseline in total synovitis score at Week 16 and the clinical efficacy variables are restricted to the Certolizumab Pegol (CZP) arm only.|||Spearman rank correlation coefficient|||Number
1403518|NCT01233284|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Mean
1403323|NCT01235598|Secondary|Change From Baseline to Week 16 in Health Assessment Questionnaire - Disability Index (HAQ-DI)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject reported questionnaire that provides an assessment of the impact of the disease and its treatment on physical function. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities, and each domain (activity) consists of 2 or 3 items. For each question the level of difficulty is scored from 0 to 3 where 0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do. A total score is computed from the item scores using the scoring rules provided by the author (Fries, 1980). The total score ranges from 0 to 3 with lower scores meaning lower disability. A negative value in HAQ-DI change from Baseline indicates an improvement.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||scores on a scale||Standard Deviation|Mean
1403324|NCT01235598|Secondary|Change From Baseline to Week 16 in Swollen Joint Count (SJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated None swelling response and Yes indicated that there was a detectable synovial thickening with or without loss of bony contours, or bulging synovial proliferation with or without cystic characteristics. If there were missing observations in the SJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. SJC ranges from 0 to 28 with 0 indicating no swollen joints and 28 indicating swelling in all joints. A negative value in SJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1403325|NCT01235598|Secondary|Change From Baseline to Week 16 in Tender Joint Count (TJC)|"The joint assessment was carried out on 28 joints. Swelling and tenderness were graded on a 2-point scale (answered with Yes/No). No indicated Not tender; Yes indicated a positive tenderness response that was defined as a positive response to questioning (tender), spontaneous response elicited (tender and winced) or withdrawal by subject on examination (tender, winced, and withdrew). If there were missing observations in the TJC, then the remaining observations were assessed and weighted by dividing by the number of non-missing joint counts and multiplying by 28. TJC ranges from 0 to 28 with 0 indicating no tender joints and 28 indicating tenderness in all joints. A negative value in TJC change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1403326|NCT01235598|Secondary|Change From Baseline to Week 16 in Bone Mineral Density as Measured by Digital XRay (DXR)|"Radiographic assessment of bone mineral density in one hand and wrist were conducted by Digital X Ray (DXR) using a standardized imaging methodology. The hand and wrist to be assessed by DXR were the same as for the Magnetic Resonance Images (MRIs). The same hand and wrist were used for all x rays. The evaluation of all DXRs was performed centrally.~A positive value in Bone Mineral Density change from Baseline indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||g/cm^2||Standard Deviation|Mean
1403327|NCT01235598|Secondary|Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 16|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication, and had a valid Baseline efficacy assessment and at least one valid post-Baseline efficacy assessment.|||percentage of subjects|||Number
1403328|NCT01235598|Secondary|Change From Baseline to Week 16 in the Disease Activity Score-28 (C-Reactive Protein) (DAS28 (CRP)) Response|DAS28[CRP] is a composite index and is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) C-reactive protein (CRP in mg/l), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x lognat (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity. A DAS(28) score of higher than 5.1 is indicative of high disease activity whereas a DAS score below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. A negative value in DAS28[CRP] change from Baseline indicates an improvement from Baseline.|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
1403329|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Criteria (ACR70) at Week 16|Subjects who meet the ACR70 criteria are those subjects with at least 70 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
1403538|NCT01233232|Primary|Change From Baseline to End of Treatment for Body Temperature|The change in body temperature (oral) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||degrees C||Standard Deviation|Mean
1403330|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Criteria (ACR50) at Week 16|Subjects who meet the ACR50 criteria are those subjects with at least 50 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
1403331|NCT01235598|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Criteria (ACR20) at Week 16|Subjects who meet the ACR20 criteria are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-Reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
1403332|NCT01235598|Secondary|Percentage of Subjects Achieving a Good European League Against Rheumatism (EULAR) Response at Week 16|"EULAR (European League Against Rheumatism) response: EULAR response is based upon current Disease Activity Score 28 (DAS28) level and corresponding change from Baseline in DAS28.~Good EULAR response is defined as: DAS28 C-Reactive Protein (CRP) ≤ 3.2 and decrease from Baseline by > 1.2; moderate response is defined as achievement of one of the following:~DAS28(CRP) ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28(CRP) > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28(CRP) > 5.1 and decrease from Baseline > 1.2"|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (observed case) which consists of all randomized subjects that received at least one dose of study medication.|||percentage of subjects|||Number
1403333|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Number of Voxels (Nvox) With Plateau and Washout Pattern|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in Nvox change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||voxels||Standard Deviation|Mean
1403334|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Maximal Enhancement (ME)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in ME change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||percent change over pre-contrast||Standard Deviation|Mean
1403335|NCT01235598|Secondary|Change From Baseline to Week 16 in the Dynamic Magnetic Resonance Image (MRI) Parameter, Initiation Rate of Enhancement (IRE)|"Contrast enhancement can be quantified in terms of the dynamic MRI parameters initial rate of enhancement (IRE), maximum enhancement (ME), and number of voxels (Nvox) with Plateau and Washout pattern. These parameters are extracted by examining individual signal intensity versus time curves derived from defined regions of interest.~Nvox indicates the number of voxels showing enhancement patterns. It is representative of the size or volume of enhancement and representative of underlying inflammation. The higher the value, the higher the volume .~ME and IRE values quantify the intensity of signal within the enhancing voxels. The absolute values and changes from Baseline in the MRI parameters of IRE, ME, and Nvox of the selected hand and wrist were estimated at Weeks 1, 2, 4, 8, and 16.~The values presented are for Proximal Interphalangeal (PIP) and Metacarpophalangeal (MCP) joints combined. A negative value in IRE change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||percent per second||Standard Deviation|Mean
1403357|NCT01235507|Secondary|Swollen and Tender Joint Counts|66 and 68 joints were assessed by the physician for tenderness or swelling respectively. The joints were counted as tender/not tender (tender=1; not tender=0) and swollen/not swollen (swollen=1; not swollen=0) and scored. The scores ranged from 0 to 66 for TJC and 0 to 68 for SJC. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point|||Joints||Standard Deviation|Mean
1403336|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 1|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
1403337|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 2|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
1403338|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 4|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
1403339|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 8|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
1403358|NCT01235507|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28|"DAS28 was calculated using the 28 joints count, the CRP and PtGA of disease activity. The following formula was used to determine DAS28.~DAS28 = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100-mm VAS).~The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Participants were considered to have low disease activity when DAS28 was less than or equal to (≤) 3.2 and in clinical remission when DAS28 scores were less than (<) 2.6"|Weeks 8, 16 and 24|ITT Population; n= number of participants analyzed for the given parameter at the specified time point|||percentage of participants|||Number
1403456|NCT01233921|Secondary|Changes in the Number of Naive CD4 T Cells in the Blood|Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin||||cells per microliter of blood||Standard Deviation|Mean
1403340|NCT01235598|Primary|Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm|"Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS):~Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the second through fifth metacarpophalangeal (MCP) joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 21. A negative value in synovitis change from Baseline score indicates an improvement."|From Baseline to Week 16|The Analysis Population refers to the Full Analysis Set (FAS) (last observation carried forward) which consists of all randomized subjects that received at least one dose of study medication. As pre-specified in the protocol, this analysis is restricted to the Certolizumab Pegol (CZP) arm.|||scores on a scale||Standard Deviation|Mean
1403341|NCT01235546|Other Pre-specified|Infant Pyloric Stenosis|Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation|up to 3 months after birth||||Participants|||Count of Participants
1403342|NCT01235546|Other Pre-specified|Neonatal Serious Adverse Events|Composite for all neonatal serious adverse events|Up to 3 months after birth||||Participants|||Count of Participants
1403343|NCT01235546|Other Pre-specified|Maternal Serious Adverse Events|All maternal serious adverse events|Up to 6 weeks after delivery||||Participants|||Count of Participants
1403344|NCT01235546|Other Pre-specified|Maternal Postpartum Antibiotic Use|Maternal postpartum use of antibiotics|Up to 6 weeks after delivery||||Participants|||Count of Participants
1403345|NCT01235546|Other Pre-specified|Maternal Postpartum Readmission or Unscheduled Visit|Maternal postpartum unscheduled visit or readmission to the hospital|Up to 6 weeks after delivery||||Participants|||Count of Participants
1403346|NCT01235546|Other Pre-specified|Maternal Fever||Up to 6 weeks after delivery|Postpartum Fever|||Participants|||Count of Participants
1403347|NCT01235546|Other Pre-specified|Neonatal Readmission||Up to 3 months after birth|Hospitalization after discharge|||Participants|||Count of Participants
1403348|NCT01235546|Other Pre-specified|Neonatal Intensive Care Unit (NICU) Admission|Neonates who are admitted to the NICU due to morbidities diagnosed from birth and up to three months of life. Morbidities as defined in the Neonatal morbidities outcome measure.|Up to 3 months after birth||||Participants|||Count of Participants
1403349|NCT01235546|Other Pre-specified|Neonatal Morbidities (Listed Below)|morbidities include: death, Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Periventricular Leukomalacia (PVL) suspected or proven sepsis, Necrotizing Enterocolitis (NEC) Intraventricular Hemorrhage (IVH) and systemic inflammatory response syndrome|Up to 3 months after birth||||Participants|||Count of Participants
1403350|NCT01235546|Primary|Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)|Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C [100.4°F]), abdominal pain, uterine tenderness, or purulent drainage from the uterus. Wound infection was defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, or breakdown alone in the absence of the preceding signs did not constitute infection.|Up to 6 weeks after delivery|The specific characteristics related to the cesarean delivery, including indications for cesarean delivery, receipt of standard prophylaxis, timing of receipt of study medication, and type of surgical skin preparation, were similar in the two groups.|||Participants|||Count of Participants
1403351|NCT01235507|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24.|Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24|Safety Analysis Population: All participants enrolled in the study who received at least 1 dose of study medication and had at least 1 post-baseline assessment of safety (such as laboratory data, vital signs, or AEs) were included.|||percentage of participants|||Number
1403352|NCT01235507|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a marker of inflammation and is measured in millimeters per hour (mm/hour). A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm/hour||Standard Deviation|Mean
1403353|NCT01235507|Secondary|CRP Levels|CRP is a marker of acute phase inflammation and is measured in mg/L. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mg/L||Standard Deviation|Mean
1403354|NCT01235507|Secondary|Participant's Global Assessment of Pain|Participant's global assessment of pain was performed using a 100 mm VAS ranging from no pain (0) at the left edge to unbearable pain (100) at the right edge. The distance in mm from the left edge of the scale was measured. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm||Standard Deviation|Mean
1403355|NCT01235507|Secondary|Participant's Global Assessment of Disease Activity|Participant's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement.|Baseline, Weeks 8, 16 and 24|ITT Population; n=number of participants analyzed for the given parameter at the specified time point|||mm||Standard Deviation|Mean
1403378|NCT01235338|Primary|AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
1403379|NCT01235338|Primary|AUC of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS|||ng*hr/ml||Standard Deviation|Mean
1403359|NCT01235507|Secondary|Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit|"DAS28 was calculated using the 28 joints count, the C-reactive protein levels (CRP) and participant's global assessment (PtGA) of disease activity. The following formula was used to determine DAS28.~DAS28 (equals) = 0.56 × (square root of) √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100- millimeter [mm] visual analog scale [ VAS]).~The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity."|Baseline, Weeks 8, 16 and 24|ITT Population; number (n) = number of participants analyzed for the given parameter at the specified time point|||units on a scale||Standard Deviation|Mean
1403360|NCT01235442|Secondary|sPGA (0,1) at Week 24|The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1403361|NCT01235442|Secondary|PASI 75 at Week 24|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 24|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1403362|NCT01235442|Secondary|Percent PASI Improvement From Baseline at Week 12|The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of Improvement in PASI score||Standard Deviation|Mean
1403363|NCT01235442|Secondary|Patient Satisfaction at Week 12|Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication’s control of psoriasis, ranging from “very satisfied” to “very dissatisfied.”|Week 12|PRO analysis set, including all subjects randomized and also complete the baseline and at least 1 of the post-baseline PRO assessment with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1403364|NCT01235442|Secondary|PASI 90 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1403365|NCT01235442|Secondary|sPGA (0,1) at Week 12|The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1403366|NCT01235442|Primary|PASI 75 at Week 12|The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.|Week 12|Intention-to-Treat with last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1403367|NCT01235403|Secondary|Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period|"The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.~The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase."|End of Treatment Period (24-week)|Safety Set|||percentage of subjects|||Number
1403368|NCT01235403|Primary|Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study|Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study (up to 24 - 28 weeks)|Safety Set|||subjects|||Number
1403369|NCT01235403|Primary|Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study|Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.|During the study ( up to 24 - 28 weeks)|Safety Set|||subjects|||Number
1403370|NCT01235377|Secondary|Factors Associated With Prescribing Patterns|factors (barriers and facilitators) associated with prescribing according to the Cluster Designation|nine months|||||||
1403371|NCT01235377|Primary|Prescription Rates|rates of provider prescribing of the Cluster Designated drug|nine months|providers prescribing a thiazide at least once in the study period|||% new thiazide prescriptions||Inter-Quartile Range|Median
1403372|NCT01235338|Secondary|Pulse Rate||Baseline and up to 39 days|SAS|||bpm||Standard Deviation|Mean
1403373|NCT01235338|Primary|Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
1403374|NCT01235338|Primary|Tmax of o-Desmethylvenlafaxine||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
1403375|NCT01235338|Primary|Tmax of Venlafaxine Hydrochloride||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
1403376|NCT01235338|Primary|Tmax of d-Amphetamine||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
1403377|NCT01235338|Primary|Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate||Day 15 and Day 30 (24 hour sampling)|PAS|||hours||Standard Deviation|Mean
1403389|NCT01235338|Primary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.|Day 15 and Day 30 (24 hour sampling)|Pharmacokinetic Analysis Set (PAS) defined as all subjects who took a t least 1 dose of investigational product and had at least 1 post-dose safety assessment and who had no major deviations related to investigational product intake (e.g. vomiting) and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/ml||Standard Deviation|Mean
1403390|NCT01235234|Secondary|Ocular Surface Disease Index|Change from Baseline in Ocular Surface Disease Indexat Week 24|24 weeks|||||||
1403391|NCT01235234|Secondary|Increase in Schirmer Test Tearing by >9mm Over Baseline|Proportion of subjects with ST wetting increase over Baseline of ≥10 mm with or without anesthesia in either eye at Week 24|24 weeks|||||||
1403392|NCT01235234|Primary|Nature and Frequency of Adverse Events|The primary efficacy comparison with respect to the rates of complete clearing of corneal staining at Week 24 was performed using a 2-sided test at level 0.025 to adjust for the comparison of 2 doses of CF101 to placebo. All between-treatment comparisons with respect to all secondary efficacy endpoints were performed using 2-sided tests at level 0.025. Between-treatment comparisons with respect to ancillary efficacy endpoints were performed using 2-sided tests at level 0.05. The primary comparison, as well as the comparisons with respect to the proportion of subjects with complete central corneal clearing (i.e., central corneal FS score=0) in the target eye and the proportion of subjects with ST ≥10 mm with or without anesthesia in either eye, was performed using the Cochran-Mantel-Haenszel test, stratified by duration of symptoms at Baseline (≤5 years or>5 years) and disease severity at Baseline (ST1-3or4-6 mm/5 minutes without anesthesia).|24 weeks|||||||
1403393|NCT01235234|Primary|Efficacy by Proportion of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24|Complete clearing of corneal staining by fluorescein staining (FS). The primary efficacy analysis was performed for 1eye (target eye), defined as the eye with the larger corneal FS value at Baseline. If both eyes had the same corneal FS value at baseline, the target eye was considered the eye with the larger central corneal staining value at Baseline. Corneal FS defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale|24 weeks||||participants|||Number
1403394|NCT01235195|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||hours||Standard Deviation|Mean
1403395|NCT01235195|Secondary|Residual Area Under the Concentration Time Curve [AUC(Res%)]|AUC(res%) is the residual AUC defined as (AUCinf minus AUClast) divided by AUCinf. AUCinf is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. AUClast is the area under the plasma concentration-time curve from zero to the last measured concentration.|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|This parameter was not analyzed. It is reported individually for each subject and not analyzed statistically.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1403396|NCT01235195|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||ng*h/mL||Standard Deviation|Mean
1403397|NCT01235195|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||hours||Full Range|Median
1403398|NCT01235195|Primary|Maximum Observed Plasma Concentration (Cmax)||Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1403399|NCT01235195|Primary|Area Under the Curve From Time Zero to 72 Hours [AUC (0-72)]|AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours (0-72).|Predose and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose|All participants: all treated participants with at least one sertraline concentration were evaluated for pharmacokinetics.|||nanogram hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1403400|NCT01234922|Secondary|Change in Ang II, VEGF, PlGF, and ACE Levels||1 week|Data were not analyzed due to insufficient accrual to the study and lack of statistical power.||||||
1403401|NCT01234922|Primary|Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter||7 days post-baseline||||Picogram/milliliter||Standard Deviation|Mean
1403402|NCT01234883|Primary|Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)|The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus.|Day 1 (4 Hours after start of IV)|The mITT population is all subjects with Baseline bicarbonate value ≤ 22 mmol/L. The mITT population was used for efficacy evaluation. The AT analysis set was defined as all subjects who received at least 5 mL of study treatment and were classified according to actual treatment received. AT population was used for AE analysis.|||mmol/L||Standard Deviation|Mean
1403403|NCT01234870|Secondary|Number of Participants With Adverse Events to Demonstrate Feasibility of a Comprehensive Cardiac Magnetic Resonance Imaging Protocol|Adverse events relating to administration of adenosine during a coronary heart disease comprehensive cardiac MRI study.|14 days||||occurances of adverse events|||Number
1403420|NCT01234714|Primary|Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)|"Liver fat content, measured by MRI, uses the in-phase/out-of-phase imaging calculated in terms of fat signal fraction (FSF).~The Clavien-Dindo Classification of Surgical Complications:~Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient"|December 2010|According to the Clavien-Dindo Classification of surgical complications: (please see) http://www.surgicalcomplication.info/|||Percentage of liver fat content||Inter-Quartile Range|Median
1403404|NCT01234870|Primary|Magnetic Resonance Image Quality Rating|The purpose of the study is to assess the incremental value of diagnostic performance using a fully-automated, motion-corrected (MC) first pass myocardial perfusion image acquisition protocol compared to images obtained under a non-corrected, breath-hold, shallow-breathing first pass myocardial perfusion image acquisition protocol in patients with suspected ischemic heart disease. The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality|Cross sectional study; magnetic resonance images were obtained on all patients using two different acquisition methods.||||units on a likert scale||Standard Deviation|Mean
1403405|NCT01234831|Secondary|Rate of Recolonization or Documented Infection With MRSA|Prospective review of microbiological data for patients enrolled in the trial to determine rate of recolonization or documented infection. Subjects in the Intervention Arm of the study who had documented clearance of colonization and met criteria for discontinuation of contract precautions, and had CP discontinued by staff (N=69) were included. Subjects who had a visit at MGH through 12/31/2012 during which a microbiology sample was obtained and MRSA was recovered (clinical or surveillance) were included.|2 years|We reviewed the data on the 69 subjects who were enrolled in the intervention arm of the trial who were cleared of colonization based on the study intervention.|||Participants|||Count of Participants
1403406|NCT01234831|Secondary|Specificity of First PCR Assay.|Specificity of the first PCR assay for subjects enrolled in active arm of trial.|1 year||||percentage of true negatives||95% Confidence Interval|Number
1403407|NCT01234831|Secondary|Sensitivity of First PCR Assay|Sensitivity of the first PCR assay for subjects enrolled in active arm of trial.|1 year||||percentage of true positives||95% Confidence Interval|Number
1403408|NCT01234831|Secondary|Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay|This outcome is the positive predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization who completed the 3 swab protocol.|1 year|Number of participants in the Active Screening arm who had completed the 3-swab protocol.|||participants|||Number
1403409|NCT01234831|Primary|Discontinuation of Contact Precautions in Both Trial Arms|"Patients known to have MRSA require Contact Precautions based on current recommendations from the Center for Disease Control and Prevention (CDC). Contact Precautions mean that hospitalized patients with a history of MRSA infection or colonization are isolated in a private room or together with patients who have the same Contact Precautions status (i.e. both with MRSA). Healthcare workers caring for such patients must wear protective gowns and gloves during interactions and use of equipment dedicated to that patient is recommended. For this study, Contact Precautions are discontinued refers to the practice of discontinuation of Contact Precautions once subjects meet criteria based on institutional infection control policy: history of MRSA but no positive culture in preceding 90 days and three negative nasal surveillance cultures obtained at least 24 hours apart in the absence of concurrent antibiotic use."|1 year|Analysis was performed on patients in both the Active Screening arm and Passive Screening arm who had completed the 3-swab protocol and all 3 swabs were negative.|||percentage of MRSA CP discontinued|||Number
1403410|NCT01234831|Primary|Completion of Screening Protocol in Both Trial Arms|Rate at which subjects in both trial arms complete the 3-swab protocol.|1 year|Participants in both the Active Screening arm and Passive Screening arm who completed the 3-swab protocol.|||percentage of subjects completed 3 swabs|||Number
1403411|NCT01234831|Primary|Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays|This outcome is the negative predictive value of a single PCR assay for subjects with a history of prior MRSA infection or colonization.|1 year|Only patients randomized to the Active Screening arm who had 3 pairs of completed nasal swabs could be analyzed for this outcome measure which is the negative predictive value of the first PCR sample compared to three culture samples for subjects with a history of prior MRSA infection or colonization.|||percentage of participants||95% Confidence Interval|Number
1403412|NCT01234766|Primary|Complete Response Rate|The primary endpoint is complete response (CR) rate. Historical complete response (CR) rate has been 35%. This rate will be considered as the null hypothesis.|3 years||||Participants|||Count of Participants
1403413|NCT01234714|Secondary|Type of Post-operative Complications|There are several different types of post-operative complications associated with liver surgery, such as liver failure, multi-organ failure, bleeding, bile leak, and sepsis.|December 2010|||||||
1403414|NCT01234714|Secondary|Cost|The total in-hospital costs were calculated for each patient in Euros.|December 2010|According to MRI|||Euros||Standard Deviation|Mean
1403415|NCT01234714|Secondary|Hospital Stay|The patient hospital stay was calculated according to the total number of days the patient was hospitalized.|December 2010|According to MRI|||days||Inter-Quartile Range|Median
1403416|NCT01234714|Secondary|Intensive Care Unit (ICU) Stay|The Intensive Care Unit (ICU) stay was calculated according to the total number of days the patients were managed in the ICU. This included also multiple ICU admissions.|December 2010|According to MRI|||days||Inter-Quartile Range|Median
1403417|NCT01234714|Secondary|Operative Time|The operation duration was measured according to the total minutes from the beginning of the operation until the end.|December 2010|According to MRI|||min||Inter-Quartile Range|Median
1403418|NCT01234714|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.|December 2010|According to MRI|||ml||Inter-Quartile Range|Median
1403419|NCT01234714|Secondary|Post-operative Alanine Transaminase (ALT) Levels|Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.|December 2010|According to the MRI liver fat content measurement.|||Units/liter||Inter-Quartile Range|Median
1403421|NCT01234675|Primary|Percentage of Total Sleep Time|Sleep measures at week 5 of the treatment period I; and upto week 12 for treatment period II Percentage of Total Sleep Time that was spent in various stages of sleep|Overnight PSG week 5/ up to week 12; milnacipran treatment||||Percent of total sleep time||Standard Error|Mean
1403422|NCT01234675|Primary|Arousal Index|Number of arousal per hours|Overnight PSG week 5/ upto week 12; milnacipran treatment||||Number of Arousals per hour||Standard Error|Mean
1403425|NCT01234675|Secondary|Subjective Measures With Change in Sleep and Change in Pain Measures|"Subjective assessments will constitute secondary endpoints and will include:~• Clinical Global Impression Improvement of Illness Scale (CGI-I) Clinical Global Impression- Severity of Illness scale (CGI-S); Medical Outcomes study Sleep Scale (MOS-SS); Fibromyalgia impact questionnaire (FIQ); Brief Pain Inventory (BPI) score-short form; Patient Global Impression of change (PGI-C); Beck Depression Inventory (BDI; Fatigue Severity Scale (FSS; Numeric Rating Scale-Sleep (NRS-S), part of subjective sleep questionnaire"|assessments made at week 1, week 6, week 14|||||||
1403426|NCT01234675|Primary|Overnight Polysomnography to Measure Sleep Disturbance With Milnacipran Treatment|Sleep measures at week 5 of the treatment period I; and upto week 12 for treatment period II|Overnight PSG week 5/ up to week 12; milnacipran treatment||||minutes||Standard Error|Mean
1403427|NCT01234467|Secondary|Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab|The major grade 3 or higher adverse events were haematological toxicities. The results below include common haematological and non-haematological toxicities of grade 3 or higher. A complete record of all adverse events are reported in the adverse events section. National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 were used to assess toxicity.|Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of patients|||Number
1403428|NCT01234467|Secondary|Overall Survival|This represents the Kaplan-Meier estimates of median overall survival defined as the time from start of treatment until death as a result of any cause.|2 years with the median follow-up of 29 months|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||Months||95% Confidence Interval|Median
1403429|NCT01234467|Secondary|Estimate of Progression-Free Survival|Progression-free survival (PFS) will be summarized using the Kaplan-Meier method. PFS was defined as the time from the start of treatment until lymphoma progression or death as a result of any cause. Progression was defined by The International Harmonization Project for Response Criteria as any new lesion or increase by ≥50% of previously involved sites from nadir.|2 years with the median follow-up of 29 months|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||Months||95% Confidence Interval|Median
1403430|NCT01234467|Secondary|Partial Response Rate|The percentage of participants achieving a partial response (PR). PR is defined by The International Harmonization Project for Response Criteria as regression of measurable disease and no new sites.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of participants||95% Confidence Interval|Number
1403431|NCT01234467|Secondary|Overall Response Rate (ORR)|The ORR consists of the complete response rate + the partial response rate (percentage of participants achieving a complete or partial response). Complete response is defined by The International Harmonization Project for Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response is defined as regression of measurable disease and no new sites.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of participants|||Number
1403432|NCT01234467|Primary|Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria|Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.|2 years|This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.|||percentage of participants||95% Confidence Interval|Number
1403433|NCT01234337|Other Pre-specified|Number of Participants With Treatment-emergent Grade 3 and 4 Laboratory Abnormalities|Hematological (anemia, hemoglobin, international normalized ratio [INR], lymphocyte, neutrophil, platelet, white blood cell [WBC]), biochemical (ALT [alanine aminotransferase], AST [aspartate aminotransferase], GGT [gamma-glutamyl-transferase], lipase, hypoalbuminemia, hypocalcemia, hyperglycemia, hyperuricemia) evaluations were done. Common terminology criteria for adverse events (CTCAE) version 4-Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization and CTCAE version 4-Grade 4: life-threatening consequences; urgent intervention were indicated.|From the start of study treatment up to 30 days after the last dose|Safety Analysis Set (SAF) was comprised of all randomized participants who received at least one dose of study medication (sorafenib, placebo or capecitabine). Participants were analyzed as treated.|||Paricipants|||Number
1403434|NCT01234337|Other Pre-specified|Area Under Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) of Capecitabine and 5-fluorouracil|AUC(0-tlast) is defined as AUC from time 0 to the last data point, calculated up by linear trapezoidal rule, down by logarithmic trapezoidal rule. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|PKS|||milligram*hour per liter||Geometric Coefficient of Variation|Geometric Mean
1403435|NCT01234337|Other Pre-specified|Maximum Observed Drug Concentration (Cmax) of Capecitabine and 5-fluorouracil|Maximum observed drug concentration, directly taken from analytical data. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. In the listed categories below, 'N' signifies the number of evaluable participants for the drug administered.|Pre-dose and 0.5, 1, 2, and 4 hours after capecitabine dosing at Cycle 2, Day 14|Pharmacokinetic Analysis Set (PKS) included all participants with a valid pharmacokinetic profile of capecitabine.|||milligram per liter||Geometric Coefficient of Variation|Geometric Mean
1403436|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score|The EQ-5D was a generic QoL preference based instrument and has been validated in the cancer populations. VAS was generated from 0 (worst imaginable health state) to 100 (best imaginable health state). This VAS score was referred to as the EQ-5D self-reported health status score. The results on ANCOVA of time-adjusted AUC were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1403437|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score|The EQ-5D was a generic Quality of life (QoL) based instrument validated in cancer populations. EQ-5D questionnaire contained a 5-item descriptive system of health states (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and visual analogue scale (VAS). A single HRQoL score ranging from -0.59 to 1 was generated from standard scoring algorithm developed by the EuroQoL was the EQ-5D index score, higher scores represent better health status. A change of at least 0.10 to 0.12 points was considered clinically meaningful. The results on the ANCOVA of time-adjusted AUC for the EQ-5D - Index Score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, and EOT (21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1403438|NCT01234337|Other Pre-specified|Patient Reported Outcomes: Functional Assessment of Cancer Therapy-Breast Symptom Index (8 Item) (FBSI-8)|The FBSI-8 was an 8-item questionnaire. Participants responded to each item using a 5-point Likert-type scale ranging from 0 (not at all) to 4 (very much). A total scale score was calculated (range from 0 to 32), with higher scores indicating low symptomatology and reflecting a better Health-Related Quality of Life (HRQoL). The results on the analysis of covariance (ANCOVA) of time-adjusted area under curve (AUC) for the FBSI-8 score were reported. The time-adjusted AUC was calculated by dividing the AUC by duration (in days) over the period of interest, and reported as 'scores on a scale'.|Day 1 of Cycles 1, 3, 5, 7, 9, 11, 13, 16, 19, 22, 25, 28, 31, 34, 37, and end of treatment (EOT, 21 days after last dose of study drug)|FAS participants with a baseline assessment and at least one post-baseline assessment during the study.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1403439|NCT01234337|Secondary|Duration of Response (DOR) by Central Reader|DOR was defined as the time from date of first response (CR or PR) to the date when PD is first documented, or to the date of death, whichever occurred first according to RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. DOR defined for confirmed responders only (that is, CR or PR). 'NA' indicates that value could not be estimated due to censored data. Median and 95% CIs were computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|Only responders in FAS were evaluated for this outcome measure.|||days||95% Confidence Interval|Median
1403440|NCT01234337|Secondary|Disease Control Rate (DCR) by Central Review|DCR was defined as the proportion of participants whose best response was CR, PR, stable disease (SD) or Non-CR/Non-PD. Per RECIST version 1.1, CR=all target lesions disappeared, any pathological lymph node, target/non-target, a reduction in short axis to <10 mm. PR=at least 30% decrease in the sum of diameters of target lesions taking as reference baseline sum diameters. PD=at least 20% increase in the sum of diameters of the target lesions, taking as a reference smallest sum on study. Appearance of new lesions and unequivocal progression of existing non-target lesions. SD=neither sufficient shrinkage qualified for PR nor sufficient increase qualified for PD, taking smallest sum of diameters as a reference. Non-CR/Non-PD=persistence of 1/more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. DCR=CR+PR+SD or Non-CR/Non-PD. CR and PR confirmed by another scan at least 4 weeks later. SD and Non-CR/Non-PD documented at least 6 weeks after randomization.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS|||percentage (%) of participants||95% Confidence Interval|Number
1403441|NCT01234337|Secondary|Objective Response Rate (ORR) by Central Review|ORR was defined as the best tumor response (Complete Response [CR] or Partial Response [PR]) observed during treatment or within 30 days after termination of study treatment, assessed according to the RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR=CR+PR. CR and PR were confirmed by another scan at least 4 weeks later.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS|||Percentage (%) of participants||95% Confidence Interval|Number
1403457|NCT01233921|Primary|Changes in the Number of Recent Thymic Emigrants (RTE) Cluster of Differentiation (CD)4 T Cells in the Blood|RTE CD4 T cells will be defined according to co-expression of CD3, CD4, CD31, CD45RA, and CCR7. Cells will be counted by flow cytometry at baseline and at 4 weeks and changes will be measured as cells per microliter of blood. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.|Baseline and 4 weeks after administration of palifermin||||cells per microliter of blood||Standard Deviation|Mean
1403442|NCT01234337|Secondary|Time to Progression (TTP) by Central Review|TTP was defined as the time from date of randomization to disease radiological progression by central review. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later or until disease radiological progression|FAS|||days||95% Confidence Interval|Median
1403443|NCT01234337|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last known alive date. Median and other 95% CIs computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years later|FAS|||days||95% Confidence Interval|Median
1403444|NCT01234337|Primary|Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1|PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.|From randomization of the first participant until approximately 3 years or until disease radiological progression|Full Analysis Set (FAS), also considered as Intent-to-treat (ITT) set, was defined as all randomized participants even if randomized but received no drug or if randomized and initially received incorrect drug prior to switching to correct study drug, these were included in FAS.|||days||95% Confidence Interval|Median
1403445|NCT01234207|Primary|Questionnaire Battery|Forced-choice Likert scale preference questionnaire|At study exit, after both Test and Control spectacles had been worn for 1 week each|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||percentage of participants|||Number
1403446|NCT01234207|Primary|Horizontal Extent of Undistorted Vision at Reading Distance|Novel apparatus designed to immobilize head and allow subject to indicate point of peripheral optical distortion on a modified Amsler-type grid|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||cm||Standard Deviation|Mean
1403447|NCT01234207|Primary|30-degree Off-axis Distance Visual Acuity, Low Contrast Chart|Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
1403448|NCT01234207|Primary|30-degree Off-axis Distance Visual Acuity, High Contrast Chart|Measured with subject immobilized in specially designed apparatus, keeping head pointed straight forward and moving only the eyes to left or right to view the off-axis chart|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
1403449|NCT01234207|Primary|Visual Acuity, Low Contrast, Near Chart|Standard assessment of low contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
1403450|NCT01234207|Primary|Visual Acuity, High Contrast, Near Chart|Standard assessment of high contrast visual acuity at near, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
1403451|NCT01234207|Primary|Visual Acuity, Low Contrast, Distance Chart|Standard assessment of low contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
1403452|NCT01234207|Primary|Visual Acuity, High Contrast, Distance Chart|Standard assessment of high contrast visual acuity at distance, as in normal clinical practice, using Baily-Lovey charts and the M&S Technologies Smart System II visual acuity projection system.|Post-1 week of wear of Test Spectacles and post-1 week of wear of Control Spectacles|95 presbyopic subjects wearing standard, non-free-form, non-customized PAL spectacles for 1 week, and individually customized, free-form surfaced PAL spectacles for 1 week, in randomized order, with a 1-week washout period|||logMAR||Standard Deviation|Mean
1403458|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECGs were centrally evaluated. ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (≥)300 milliseconds (msec) or ≥25% increase when baseline is greater than (>)200 msec and ≥50% increase when baseline is less than or equal to (≤)200 msec; QRS interval ≥200 msec or ≥25%/50% increase from baseline; and QTcF ≥450 msec or ≥30 msec increase.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.|||participants|||Number
1403459|NCT01233869|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug; n=the number of participants analyzed in the respective arms.|||participants|||Number
1403460|NCT01233869|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1403461|NCT01233869|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 30 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1403462|NCT01233869|Secondary|Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Scale Scores at Month 25|The KDQoL-36 is a 36-item questionnaire on kidney disease-specific measure of patient-reported quality of life with 5 subscales: physical and mental functioning (items 1-12); burden of kidney disease subscale (items 13-16); symptoms and problems (items 17-28); effects of kidney disease on daily life subscale (items 29-36). The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better quality of life.|Baseline and end of ITPV (Month 25)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout); n=the number of participants analyzed in the respective arms.|||units on a scale||Standard Deviation|Mean
1403463|NCT01233869|Secondary|Observed Accumulation Ratio (Rac) of Bosutinib|Observed accumulation ratio (Rac) was calculated as AUC from time 0 to 24 hours (Day 15) divided by AUC from time 0 to 24 hours (Day 1).|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1403464|NCT01233869|Secondary|Terminal Elimination Half-Life (t1/2) of Bosutinib|t1/2 is the time measured for the plasma concentration to decrease by one half.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore t1/2 was not reported.||||||
1403465|NCT01233869|Secondary|Apparent Volume of Distribution (Vz/F) of Bosutinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. There was no sufficient data to well-characterize the terminal phase, therefore Vz/F was not reported.||||||
1403466|NCT01233869|Secondary|Apparent Oral Clearance (CL/F) of Bosutinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1403467|NCT01233869|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of Bosutinib||Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1403468|NCT01233869|Secondary|Area Under the Concentration-Time Profile From Time 0 to the Dosing Interval (AUCtau) of Bosutinib|Area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau=24 hours.|Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1403469|NCT01233869|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.|||hours||Full Range|Median
1403470|NCT01233869|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bosutinib||Day 1 (pre-dose and 1, 3, 5 and 24 hours post-dose), Day 15 (pre-dose and 1, 2, 3, 4, 6, 8 and 24 hours post-dose)|The pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest; n=the number of participants analyzed at that time point in the respective arms.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1403471|NCT01233869|Secondary|Number of Participants With High Serum Creatinine (SCr) Levels|A SCr test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high SCr level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1403472|NCT01233869|Secondary|Number of Participants With High Blood Urea Nitrogen (BUN) Levels|A BUN test can reveal how well the kidneys are working by measuring the amount of urea nitrogen in the blood. A high BUN level (>1.3 times the upper limit of normal) may suggest that the kidneys are not working properly. Month 25 is the end of the ITPV.|Day 15, Months 6, 12, 18, 24, and 25 (end of ITPV)|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
1403473|NCT01233869|Secondary|Time to First Occurrence of End-Stage Renal Disease (ESRD) Requiring Dialysis >=56 Days|ESRD is when the kidneys permanently fail to work at a level needed for daily life. No participants developed ESRD during the treatment period, therefore the analysis of the onset of ESRD requiring ≥56 days of dialysis was not performed.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
1403474|NCT01233869|Secondary|Time to First Occurrence of Proteinuria|Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. The numbers presented correspond to the very first occurrence of proteinuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
1403475|NCT01233869|Secondary|Time to First Occurrence of Gross Hematuria|Gross hematuria is the presence of blood in the urine (defined as pink, red, or cola-colored urine due to the presence of red blood cells). The numbers presented correspond to the very first occurrence of gross hematuria in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
1403476|NCT01233869|Secondary|Time to First Occurrence or Worsening of Back and/or Flank Pain|The time to first occurrence or worsening of back and/or flank pain was observed (defined as initial onset of polycystic kidney disease [PKD]-related chronic back and/or flank pain; initiation of pain medication treatment for PKD-related chronic back and/or flank pain; addition of a pain medicine for treatment of PKD-related chronic back and/or flank pain; increase in dose of pain medication for treatment of PKD-related chronic back and/or flank pain). The numbers presented correspond to the very first occurrence or worsening of back and/or flank pain in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
1403477|NCT01233869|Secondary|Time to First Occurrence or Worsening of Hypertension|The time to first occurrence or worsening of hypertension was observed (defined as the need for increased dose of or need for additional anti-hypertensive medication). The numbers presented correspond to the very first occurrence or worsening of hypertension in that treatment group.|Baseline up to Month 25 (end of ITPV)|The mITT-2 population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment (elimination of 1-month washout requirement).|||days|||Number
1403478|NCT01233869|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Months 12, 24, 25 and Early Termination|eGFR was centrally evaluated. Glomerular filtration rate (GFR) is an index of kidney function that describes the flow of filtered fluid through the kidney. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation was used to calculate eGFR. Month 25 is the end of the ITPV.|Baseline, Month 12, Month 24, Month 25 (end of ITPV), and early termination|The mITT population included all participants who were randomized and received at least 2 weeks' worth of treatment and have at least 1 post-randomization follow-up MRI assessment; n=the number of participants analyzed at that time point in the respective arms.|||mL/min/1.73m^2||Standard Deviation|Mean
1403479|NCT01233869|Primary|Change From Baseline (CFB) in Total Kidney Volume (TKV) at Month 25|TKV was measured by centrally evaluated Magnetic Resonance Imaging (MRI).|Baseline and Month 25 (end of Initial Treatment Period Visit [ITPV])|The modified intent-to-treat (mITT) population included all participants who were randomized and received at least 2-weeks' worth of treatment and have at least 1 follow-up MRI assessment that was preceded by a 1-month washout of the study drug; n=the number of participants analyzed at that time point in the respective arms.|||centimeter cube (cm^3)||Standard Deviation|Mean
1403481|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 4|Number of participants with infectious complications is provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||participants|||Number
1403482|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 3|The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||number of new cases per 1000 days|||Number
1403483|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 2|Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||participants|||Number
1403484|NCT01233726|Secondary|Assessment of Critical Ill Patients Progress During Hospital Stay 1|Infectious complication incidence rate per 100 days of treatment are provided in this table.|100 days of treatment|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||percentage of patients with infection|||Number
1403485|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2|"This table shows the rates of:~Controls analysis on 80-150 mg/dL: optimal level of glycemia rate.~Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate.~Hypoglycemia (<50 mg/dL): severe hypoglycemia episodes rate."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||% of capillary glycemia measurements|||Number
1403486|NCT01233726|Primary|Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1|This table shows the number of capillary glycemia measurements|28 days post-admission||||number of capillary glycemia measurement|||Number
1403487|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 5|"The variables recorded related to Glycemic CV (%) are provided in this table:~Glycemic Coeficient of variation (%) after 28 days in ICU~Glycemic Coeficient of variation (%) after 7 days in ICU."|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||percentage of Glycemic CV||Standard Deviation|Mean
1403488|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 4|The variables recorded related to the number of measurements per patient per day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||Measurements per patient/day||Standard Deviation|Mean
1403489|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 3|The variables recorded related to number of capillary glycemia measurements are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||Capillary glycemia measurements|||Number
1403490|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 2|The variables recorded related to administered insulin in IU/day are provided in this table|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||IU/day||Standard Deviation|Mean
1403491|NCT01233726|Primary|Measure of Biochemical Parameters and Evaluation of Infectious Complications 1|The variables recorded related to glycemic control in mg/dL are provided in this table.|28 days post-admission|Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission.|||mg/dL||Standard Deviation|Mean
1403492|NCT01233687|Secondary|Overall Survival (OS)|Overall Survival was computed for all participants and is defined as the time between start of treatment and death. The (median) length of time in months that subjects with previously-treated advanced NSCLC, treated with the combination of AMG 102 and erlotinib, remain alive estimated by the Kaplan-Meier method.|Up to 24 months (after the first evaluable patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||months||90% Confidence Interval|Median
1403493|NCT01233687|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from the start of treatment until first evidence of disease progression, death, or date of last contact. The (median) length of time that subjects with previously-treated advanced NSCLC, who were treated with the combination of AMG 102 and erlotinib, are both alive and free of disease progression as estimated by the Kaplan-Meier method. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).|Up to 24 months (after the first patient is accrued)|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||months||90% Confidence Interval|Median
1403494|NCT01233687|Secondary|Objective Response Rate (ORR/Clinical Response)|Using RECIST v1.1 criteria, ORR was determined by following equation: the number of partial response (PR) participants / the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Up to 6 months|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||percentage of patients||90% Confidence Interval|Number
1403495|NCT01233687|Primary|Disease Control Rate (DCR)|Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.|Six weeks from initiation of treatment with AMG 102 + Erlotinib|All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)|||percentage of patients||90% Confidence Interval|Number
1403496|NCT01233687|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity|Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.|During first cycle of treatment (3 weeks)|In the absence of DLTs among the first 7 pts treated, AMG 102 + Erlotinib (150 mg) daily (3 weeks) was declared the RP2D.|||percentage of participants||90% Confidence Interval|Number
1403497|NCT01233609|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity|Mean change in best corrected visual acuity as assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) method from baseline to week 52|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||letters read correctly||Standard Deviation|Mean
1403498|NCT01233609|Secondary|Static Perimetry Volume--30 Degree Hill of Vision|Mean Change from baseline to week 52 for Static Perimetry Volume --30 Degree Hill of Vision. Full field static perimetry protocol was followed using the Octopus 900 (Haag-Streit) for a single session for each eye.|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||db-steridans|eyes|Standard Deviation|Mean
1403499|NCT01233609|Secondary|Static Perimetry by Treatment Arm--Full Field Hill of Vision|Mean change from baseline at week 52 for Full field Hill of Vision (Static perimetry)|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||db-steridians|eyes|Standard Deviation|Mean
1403500|NCT01233609|Secondary|Mean Change in Visual Field Area From Baseline to 52 Weeks--I4e Isopter|Mean change in visual field area from baseline to 52 weeks. Visual field area is measured with semi-automated kinetic perimetry (SKP) using the Octopus 900 (Haag-Streit) with the I4e target size for each eye and done at least twice to ensure reliable sessions; the visual field area measurements are averaged over the two sessions. Analysis performed with linear mixed model|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||Visual field area (degrees squared)|eyes|Standard Deviation|Mean
1403501|NCT01233609|Primary|Mean Change in Visual Field Area From Baseline to 52 Weeks--III4e Isopter|Mean change in visual field area from baseline to 52 weeks. Visual field area is measured with semi-automated kinetic perimetry (SKP) using the Octopus 900 (Haag-Streit) with the III4e target size for each eye and done at least twice to ensure reliable sessions; the visual field area measurements are averaged over the two sessions. Analysis performed with linear mixed model|baseline to week 52|The analysis followed the intent-to-treat principle in that all randomized participants were included and analyzed according to their treatment assignment regardless of amount or type of treatment received. Only observed data were analyzed.|||Visual field area (degrees squared)|eyes|Standard Deviation|Mean
1403502|NCT01233284|Secondary|FVC Area Under the Curve Within 24 Hours (h) Response (FVC AUC0-12h, FVC AUC12-24h, FVC AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-12, FVC AUC12-24 and FVC AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.|||Litres||Standard Error|Mean
1403517|NCT01233284|Secondary|FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Mean
1403503|NCT01233284|Secondary|FEV1 Area Under the Curve Within 24 Hours (h) Response (FEV1 AUC0-12h, FEV1 AUC12-24h, FEV1 AUC0-24h)|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-12, FEV1 AUC12-24 and FEV1 AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration|FAS24 was defined as all patients in the FAS who gave informed consent for the 24-h PFT and who participated in this optional PFT.|||Litres||Standard Error|Mean
1403504|NCT01233284|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for nighttime awakenings|||Night awakenings||Standard Error|Mean
1403505|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.|||Puffs||Standard Error|Mean
1403506|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.|||Puffs||Standard Error|Mean
1403507|NCT01233284|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing data for rescue medication.|||Puffs||Standard Error|Mean
1403508|NCT01233284|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent . Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and 4 weeks|FAS reduced to patients with non-missing morning and evening PEF data.|||Percentage of the mean daily PEF||Standard Error|Mean
1403509|NCT01233284|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing evening PEF data.|||Litre/min||Standard Error|Mean
1403510|NCT01233284|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).|Baseline and 4 weeks|FAS reduced to patients with non-missing morning PEF data.|||Litre/min||Standard Error|Mean
1403511|NCT01233284|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing PEF data.|||Litre/min||Standard Error|Mean
1403512|NCT01233284|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
1403513|NCT01233284|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Mean
1403514|NCT01233284|Secondary|FVC AUC0-3h Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
1403515|NCT01233284|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FVC was measured just prior to the last administration of randomised treatment.|Baseline and 4 weeks|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
1403516|NCT01233284|Secondary|Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response|MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|FAS reduced to patients with non-missing FVC data.|||Litre||Standard Error|Mean
1403519|NCT01233284|Primary|Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response|Mixed model repeated measurement (MMRM) results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.|10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration|Full analysis set (FAS) reduced to patients with non-missing FEV1 data. The FAS is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.|||Litre||Standard Error|Mean
1403520|NCT01233258|Other Pre-specified|Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of rFVIII (BAY81-8973)|3, 6, 9 and 12 months after baseline|Safety population|||Participants|||Number
1403521|NCT01233258|Other Pre-specified|Number of Bleeds During Treatment|The number of bleeds experienced by each participant|12 months|ITT|||Bleeds||Inter-Quartile Range|Median
1403522|NCT01233258|Secondary|Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973)|The percentage of bleeds per participant on on-demand treatment that stopped after two or fewer injections|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT|||Percentage of bleeds||Full Range|Median
1403523|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/ADJ Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/ADJ|Up to 6 months (6 months on CS/ADJ potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.|||Bleeds per year per participant||Standard Deviation|Mean
1403524|NCT01233258|Secondary|Annualized Number of All Bleeds During CS/EP Period|The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/EP|Up to 6 months (6 months on CS/EP potency assignment)|ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.|||Bleeds per year per participant||Standard Deviation|Mean
1403525|NCT01233258|Primary|Annualized Number of All Bleeds|The annualized number of bleeds experienced by participants|Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)|ITT (Intent to Treat). Low and high dose prophylaxis arms and both potencies combined as planned for the statistical analysis to achieve intended sample size.|||Bleeds per year per participant||Standard Deviation|Mean
1403526|NCT01233232|Secondary|Maximum Reduction of Circulating Neutrophils in Blood, From Baseline|The change in circulating neutrophils in blood is calculated as the visit value minus the Baseline value. Only participants with reduction are considered.|Baseline (last non-missing assessment prior to first dose of study medication), weeks 1, 2 and 3, and End of Treatment (Day 28)||||10^9/L cells/L||Standard Deviation|Mean
1403527|NCT01233232|Secondary|Time to Maximum Plasma Concentration for AZD5069|Time (in relation to dosing) at which the maximum plasma concentration is observed.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing||||hours||Inter-Quartile Range|Median
1403528|NCT01233232|Secondary|Maximum Plasma Concentration for AZD5069|The maximum plasma concentration (Cmax) is the highest level of drug in plasma.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1403529|NCT01233232|Secondary|Area Under the Plasma Concentration Curve of AZD5069|The area under the plasma concentration curve is estimated from time 0 (dosing) to 24 hours after dosing.|End of Treatment (Day 28); pre-dose, 1, 2, 3, and 5 hours after dosing||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1403530|NCT01233232|Secondary|Plasma Concentration of AZD5069 After 1 Hour of Dosing|At this visit, approximately 1 hour after dosing (at the clinic), a blood sample was collected for determination of drug concentration in plasma.|End of Treatment (Day 28), 1 hour after dosing||||nmol/L||Standard Deviation|Mean
1403531|NCT01233232|Primary|Change From Baseline to End of Treatment for Total Protein (Urinalysis)|The change in total protein in urine is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||g/L||Standard Deviation|Mean
1403532|NCT01233232|Primary|Number of Participants Who Developed High Transaminase Values (Clinical Chemistry)|High Transaminase Values are defined as a measurment of ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than or equal to 3 times the upper limit of normal (ALT ULN = 36 IU/L, AST ULN = 33 IU/L).|Up to Follow-up Visit (3 to 18 days after End of Treatment [Day 28])||||Participants|||Number
1403533|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Post-bronchodilator (Lung Function Test)|The change in FEV1 Post-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||L||Standard Deviation|Mean
1403534|NCT01233232|Primary|Change From Baseline to End of Treatment for FEV1 Pre-bronchodilator (Lung Function Test)|The change in FEV1 Pre-bronchodilator is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||L||Standard Deviation|Mean
1403535|NCT01233232|Primary|Change From Baseline to End of Treatment for Pulse Rate (Vital Signs)|The change in pulse rate (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||beats/minute||Standard Deviation|Mean
1403536|NCT01233232|Primary|Change From Baseline to End of Treatment for Diastolic Blood Pressure (Vital Signs)|The change in diastolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||mmHg||Standard Deviation|Mean
1403537|NCT01233232|Primary|Change From Baseline to End of Treatment for Systolic Blood Preassure (Vital Signs)|The change in systolic blood pressure (Vital Sign) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||mmHg||Standard Deviation|Mean
1404221|NCT01227785|Primary|Clinical Performance at1-month for LV Pacing Threshold|LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.|1-month|73 CRT-D patients had data available at 1-month visit.|||volts (V)||Standard Deviation|Mean
1403539|NCT01233232|Primary|Change From Baseline to End of Treatment for Leucocytes Count in Blood (Safety Blood Sample)|The change in circulating leucocyte counts (including neutrophils) is calculated as the End of Treatment value minus the Baseline value.|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||10^9/L cells/L||Standard Deviation|Mean
1403540|NCT01233232|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|ECGs were recorded in the supine position after the patient has rested for 10 minutes. Heart rate, QRS duration, PR, RR and QT intervals were recorded. Overall evaluation of the ECG is classified as normal, abnormal or borderline. Only participants with ECG at baseline classified as normal are reported (ie, only changes from normal to abnormal).|Baseline (last non-missing assessment prior to first dose of study medication) and End of Treatment (Day 28)||||Participants|||Number
1403541|NCT01233232|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination includes assessment of general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, musculo-skeletal (including spine and extremities), cardiovascular, lungs and abdomen. The findings were deemed to be normal/abnormal based on the clinical judgment of the investigator.|Last Observation on Treatment (up to Day 28)||||Participants|||Number
1403542|NCT01233232|Primary|Patients Who Experienced at Least One Adverse Events(s)|Adverse event (AE) data, both serious and non-serious. An AE is the development of an undesirable medical condition (eg, nausea, chest pain, tachycardia, laboratory findings) or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|From start of treatment (Day 0) up to 28 days (End of Treatment)||||Participants|||Number
1403543|NCT01233076|Primary|Overall Vision Quality|Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
1403544|NCT01233050|Secondary|Length of Hospital Stay||within 35 days of randomization to treatment assignment||||days||Standard Deviation|Mean
1403545|NCT01233050|Secondary|Number and Percentage of Participants With Organ Space Infection||within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
1403546|NCT01233050|Secondary|Number and Percentage of Participants With Deep Wound Infection||within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
1403547|NCT01233050|Secondary|Bacterial Pathogens Present in Documented Surgical Site Infection||within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
1403548|NCT01233050|Secondary|Time to Develop Surgical Site Infection|average time from surgery to surgical site infection diagnosis|within 35 days of randomization to treatment assignment||||days||Standard Error|Mean
1403549|NCT01233050|Primary|The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.|The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC.|within 35 days of randomization to treatment assignment||||Participants|||Count of Participants
1403550|NCT01232920|Secondary|Number of Eyes With Resolution of Macular Edema||6 months||||Eyes|Participants||Number
1403551|NCT01232920|Secondary|Change in Best Spectacle-corrected Visual Acuity (BSCVA)|Change in best spectacle-corrected visual acuity (BSCVA) from baseline. Analysis on eye level|6 months||||LogMAR|Participants|Standard Deviation|Mean
1403552|NCT01232920|Secondary|Time to Control of Inflammation||6 months||||days||Inter-Quartile Range|Median
1403553|NCT01232920|Primary|Number of Participants Achieving Treatment Success|"TREATMENT SUCCESS is defined as controlled ocular inflammation in both eyes with less than or equal to 10 mg/day of prednisone and/or 2 topical steroid drops/day sustained for 2 visits separated by at least 28 days (control of inflammation and prednisone dose must be achieved by 5-month visit and sustained until 6-month visit).~Discontinuation of study medication at any time due to efficacy, tolerability, or safety may result in a declaration of TREATMENT FAILURE. Note that all patients will be classified as either a treatment success or failure."|6 months||||participants|||Number
1403554|NCT01232894|Primary|Change From Baseline on Clinical COPD Questionnaire (CCQ) Score|The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same.|Baseline and 12 weeks|Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis.|||units on a scale||Standard Deviation|Mean
1403555|NCT01232868|Secondary|Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures|The secondary outcomes will identify the number of participants with a positive B cell response to the flu shot particulary looking for antibody responses, presence of plasmablasts, antibody repertoire.|2 years||||participants|||Number
1403556|NCT01232868|Primary|Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures|The number of subjects with a change in innate immunity signatures correlating with the level of antibodies was recorded. The innate immune signatures were assessed by Fluorescence Activated Cell Sorting (FACS)/Luminex assays. The levels of antibodies to the influenza virus prior to TIV (trivalent influenza vaccine) administration and on Day 180 after receiving TIV was assessed and the number of subjects who exhibited an increase in the antibodies and, therefore, a change in their innate immune signatures, was recorded.|Day 0 (prior to TIV administration), Day 180 (from the time of of TIV administration)||||participants|||Number
1404222|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Pacing Threshold|LV pacing threshold results were reported at pre-discharge for CRT-D patients.|pre-discharge|75 patients had data available at pre-discharge|||volts (V)||Standard Deviation|Mean
1403557|NCT01232829|Secondary|Time to Disease Progression|Eighteen patients were evaluable for the time to disease progression endpoint.|From registration to documentation of disease progression, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the progression-free survival.|||months||95% Confidence Interval|Median
1403558|NCT01232829|Secondary|Survival|Survival was estimated using the Kaplan-Meier (1958) method.|From registration to death due to any cause, assessed up to 2 years|All patients meeting the eligibility criteria and who received treatment per protocol (n=18) were evaluable for the overall survival endpoint.|||months||95% Confidence Interval|Median
1403559|NCT01232829|Primary|Survival Rate|The primary endpoint of the study was 6-month survival. The proportion of successes was estimated by the number of successes divided by the total number of evaluable patients.|6 months|All patients meeting the eligibility criteria and who received treatment were considered evaluable for the primary endpoint. All patients treated per protocol (n=18) were evaluable for the 6-month survival endpoint.|||participants|||Number
1403560|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Change from PreScreening at End of Trial|Analyses only used matched cases and does not include participants with incomplete data.|||units on a scale||Standard Deviation|Mean
1403561|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|End of Trial|Per protocol|||units on a scale||Standard Deviation|Mean
1403562|NCT01232790|Secondary|Brief Psychiatric Rating Scale (BPRS)Total Score|"Brief Psychiatric Rating Scale (BPRS) utilized before and after treatment. BPRS total score is a total of the 18 item scores with a range of 18-126. It is used to measure schizophrenia symptoms and to assess change in them over time. There are 18 symptom sub scores. Each symptom is rated 1-7 (not present to extremely severe) and then all items are summed for the total score. Higher scores indicate more severe symptoms.~The BPRS is the gold-standard overall measure of schizophrenia symptoms which will be utilized to demonstrate that the intervention does not cause worsening of the illness symptoms apart from the usual fluctuations of the natural course."|Pre Screening|Per protocol|||units on a scale||Standard Deviation|Mean
1403563|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Per protocol|||units on a scale||Standard Deviation|Mean
1403564|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.|||units on a scale||Standard Deviation|Mean
1403565|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Per protocol|||units on a scale||Standard Deviation|Mean
1403566|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those dropped out from the study.|||units on a scale||Standard Deviation|Mean
1403623|NCT01232504|Primary|Incidences of Invasive Fungal Diseases (IFD)|The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation|100 day post transplant|The number of intention-to-treat patients is 206. The incidence of invasive fungal infection analysis within 100 day is based on intention-to-treat (ITT)patients .|||percentage of partipants|||Number
1403567|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
1403568|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline 1st Leg of Crossover|Per protocol|||units on a scale||Standard Deviation|Mean
1403569|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Change from Baseline at Follow Up (Baseline - Follow Up)|Subjects analyzed are those with complete data at all timepoints and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
1403570|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up 1st Leg of Crossover (5 Days)|Per protocol|||units on a scale||Standard Deviation|Mean
1403571|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up in the crossover and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
1403572|NCT01232790|Secondary|Brief Visuospatial Memory Test (BVMT) RAW SCORE.|Brief Visuospatial Memory Test (BVMT) is a measure of visuospatial memory. This task includes three trials of six geometric figures printed in a 2 x 3 array on separate pages. The respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Scoring is based on accuracy of the figure as well as its location on the page. A range of 0-12 per trial is possible(0-36 total). Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).|||units on a scale||Standard Deviation|Mean
1403573|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 2nd Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at 2nd follow up in the crossover and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
1403574|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 2nd Leg of Crossover|Subjects analyzed are those with complete data at 2nd baseline in the crossover and could include those that had dropped from the study if data was collected prior to drop out.|||units on a scale||Standard Deviation|Mean
1403624|NCT01232504|Secondary|Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)|Incidence of Ⅱ- Ⅳacute graft versus host disease (aGVHD) within 100 days after allogeneic stem cell transplantation (Allo-HSCT).The severity of acute GVHD in the three main target organs (skin, liver, gastrointestinal tract) was assigned stage 1 to 4 based on accepted criteria (Consensus Conference on Acute GVHD Grading).|100 days post transplant|The number of intention-to-treat patients is 206. The incidence of aGVHD analysis is based on intention-to-treat (ITT) patients .|||percentage of partipants||95% Confidence Interval|Number
1403575|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up 1st Leg of Crossover (5 Days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
1403576|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
1403577|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Change from Baseline at Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
1403578|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
1403579|NCT01232790|Secondary|Letter/Number Sequencing Task Tests for Attention, Concentration & Mental Control (LNS) RAW SCORE.|Letter Number Sequencing (LNS) is a brief, standardized executive function task used to assess verbal working memory performance. The test involves a 24-item Experimental Condition, in which participants are read a series of letters and numbers and asked to recite both back in ascending order, with the numbers first and then the letters. Participants receive one point for each correct answer for a range of 0-24. Higher scores are better.|Baseline|All participants were analyzed that had baseline data collected (including any that did not complete the time frame).|||units on a scale||Standard Deviation|Mean
1403580|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline 1st Leg of Crossover|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
1403581|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Change from Baseline at Follow Up (5 days)|Subjects analyzed are only those with complete data at baseline and 5 day follow up in the study.|||units on a scale||Standard Deviation|Mean
1403582|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Follow Up (5 days)|Subjects analyzed are those with complete data at follow up and does not include those that had dropped from the study.|||units on a scale||Standard Deviation|Mean
1403625|NCT01232504|Secondary|Transplant Related Mortality|Transplant related mortality within 100 days after Allogeneic Stem Cell Transplantation (Allo-HSCT).|100 days post transplant|The number of intention-to-treat patients is 206. The transplant related mortality analysis within 100 day is based on intention-to-treat (ITT) patients .|||percentage of participants||95% Confidence Interval|Number
1403583|NCT01232790|Primary|BACS Composite RAW Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcome in patients with schizophrenia.~The BACS composite raw score the total of the raw scores for the 6 subtests of the BACS (Verbal memory, token motor, digit sequencing, verbal fluency, symbol coding and executive functioning). The range, so we could be from 0-435. A high score total score is more favorable and indicates a higher level of cognition.~The BACS requires less than 35 min to complete in patients with schizophrenia, yields a high completion rate in these patients, and has high reliability. The BACS was found to be as sensitive to cognitive impairment in patients with schizophrenia as a standard battery of tests that required over 2 h to administer. It is the raw sum of the test items and higher scores are favorable."|Baseline|Subjects analyzed are those with complete data at baseline prior to dropout from the study.|||units on a scale||Standard Deviation|Mean
1403584|NCT01232738|Other Pre-specified|Change in ORAC Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Trolox equivalents||95% Confidence Interval|Mean
1403585|NCT01232738|Other Pre-specified|Change in ORAC Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||umol Trolox equivalents||95% Confidence Interval|Mean
1403586|NCT01232738|Other Pre-specified|Change in ORAC Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Oxygen Radical Antioxidant Capacity. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Trolox equivalents||95% Confidence Interval|Mean
1403587|NCT01232738|Other Pre-specified|Change in BCL2/BAX Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker BCL2/BAX. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 10 subjects that completed the study were able to have this biomarker analyzed.|||Ratio||95% Confidence Interval|Mean
1403588|NCT01232738|Other Pre-specified|Change in Percent Annexin V Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarker Annexin V %. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Annexin V %||95% Confidence Interval|Mean
1403589|NCT01232738|Other Pre-specified|Change in Mitotracker Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarkerMitotracker. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 17 subjects that completed the study were able to have this biomarker analyzed.|||Relative Fluorescent Intensity||95% Confidence Interval|Mean
1403590|NCT01232738|Other Pre-specified|Change in JC-1 Mitochondrial Biomarkers|The 12 month change in mitochondrial biomarkerJC-1 red/green fluorescence ratio. We measured at baseline, 6 months and 12 months.|Baseline, 6 months, 12 months|Only 14 subjects that completed the study were able to have this biomarker analyzed.|||ratio||95% Confidence Interval|Mean
1403591|NCT01232738|Secondary|Difference in Time to Treatment Failure|This group is defined as death, endotracheal intubation, tracheostomy-assisted ventilation or use of noninvasive ventilation >= 23 hours/day for 14 days or more.|up to 12 months|Failure was defined as death, endotracheal intubation, tracheostomy-assisted ventilation, or use of noninvasive ventilation 23 hours/day for 14 days or more. It is defined in years.|||years||95% Confidence Interval|Median
1403592|NCT01232738|Primary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)|The primary outcome measure is the difference in the rate of decline in function, as detected by the ALS Functional Rating Scale - Revised (ALSFRS-R) in patients taking rasagiline compared to a database of patients from randomized clinical trials conducted during 1997-2007. Minimum score is 0 (no function) to Maximum score is 48 (normal function)|up to 12 months|The placebo arm are from the randomized, controlled studies in ALS performed during 2004-2010, corrected for symptom duration.|||units on a scale||Standard Error|Mean
1403593|NCT01232569|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||g/L||Standard Deviation|Mean
1403594|NCT01232569|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1403595|NCT01232569|Secondary|Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1403626|NCT01232504|Secondary|Hematological Engraftment|The median time of neutrophil and platelet recovery .|100 days post transplant|The number of intention-to-treat patients is 206. The hematological engraftment analysis within 100 day is based on intention-to-treat (ITT)patients .|||days||Full Range|Median
1403596|NCT01232569|Secondary|Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients|||Number
1403597|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
1403598|NCT01232569|Secondary|Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
1403599|NCT01232569|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1403600|NCT01232569|Secondary|Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
1403601|NCT01232569|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1403602|NCT01232569|Secondary|Change From Baseline in the Patient’s Pain Visual Analog Score|Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented “no pain” and the extreme right end represented “unbearable pain”. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1403603|NCT01232569|Secondary|Change From Baseline in the Patient’s and the Physician’s Global Assessment of Disease Activity Visual Analog (VAS) Score|Patients and physicians assessed the patient’s disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end represented “maximum disease activity”. Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1403604|NCT01232569|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||mm/hr||Standard Deviation|Mean
1403605|NCT01232569|Secondary|Change From Baseline in C-reactive Protein at Week 24||Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||mg/dL||Standard Deviation|Mean
1403606|NCT01232569|Secondary|Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24|Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Joint count||Standard Deviation|Mean
1403607|NCT01232569|Secondary|Time to Onset of ACR20, ACR50, and ACR70 Responses|Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Days||95% Confidence Interval|Median
1403608|NCT01232569|Secondary|Percentage of Patients With ACR50 and ACR70 Responses at Week 24|A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
1403609|NCT01232569|Primary|Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
1403610|NCT01232556|Primary|Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)|Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..|Up to 20 weeks after the first dose of study drug|Safety Population - included all participants who received at least 1 dose of test article (either inotuzumab ozogamicin administrated in combination with rituximab or investigator’s choice). This population only excluded participants who never received any test article.|||Percentage of Participants|||Number
1403611|NCT01232556|Secondary|Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire|FACT-Lym is a questionnaire that begins with 27 items covering four core Health-Related Quality of Life subscales: Physical Well-being (7 items), Social/Family Well-being (7), Emotional Well-being (6), and Functional Well-being (7). The FACT-Lym also includes an additional concerns subscale (15 items). It also asks participants about their concerns about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. The participants were requested to circle one number on a 0 to 4 points scale per line to indicate how true each statement has been for him/her during the past 7 days. FACT-Lym total score, which was reported, was derived based on FACT-Lym scoring guideline (Version 4). The range of FACT-Lym total score is 0 to 168. Higher scores mean better outcomes. The average post-baseline FACT-Lym total scores were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.|Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported|ITT population|||Unit on a scale||95% Confidence Interval|Mean
1403627|NCT01232491|Secondary|Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.|||rate per year of patient exposure|||Number
1403612|NCT01232556|Secondary|Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire|EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12.|Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported|ITT population|||Unit on a scale||95% Confidence Interval|Mean
1403613|NCT01232556|Secondary|Duration of Response|The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT population; only participants with a CR, unCR, PR, or unPR were included in the analysis|||Months||95% Confidence Interval|Median
1403614|NCT01232556|Secondary|Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL|"CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).~Partial Response (PR) requires the following:~≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.~No increase in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.~With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR).~The 95% CI was determined using the exact method based on binomial distribution."|Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
1403615|NCT01232556|Secondary|Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL|"CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).~Partial Response (PR) requires the following:~≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.~No increase in the size of other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.~With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.~No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution."|Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
1403616|NCT01232556|Secondary|Progression-Free Survival (PFS)|"PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator’s claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.~PD requires the following:~Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.|ITT Population|||Months||95% Confidence Interval|Median
1403617|NCT01232556|Primary|Overall Survival|Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.|From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.|ITT Population.|||Months||95% Confidence Interval|Median
1403618|NCT01232504|Secondary|Infection Related Mortality|Infection related mortality after a median follow-up of 600 days.|3～1099 days)|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
1403619|NCT01232504|Secondary|Hemorrhage Related Mortality|Hemorrhage related mortality after a median follow-up of 600 days|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
1403620|NCT01232504|Secondary|Graft Versus Host Disease (aGVHD) Related Mortality|Graft versus host disease (aGVHD) related mortality after a median follow-up of 600 days .|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
1403621|NCT01232504|Secondary|Relapse Related Mortality|Relapse related mortality after a median follow-up of 600 days.|3～1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants|||Number
1403622|NCT01232504|Secondary|IFD Related Mortality|IFD-related mortalities after a median follow-up of 600 days.|3-1099 days|The number of intention-to-treat patients is 206. The IFD related mortality analysis is based on intention-to-treat (ITT) patients .|||percentage of participants||95% Confidence Interval|Number
1403628|NCT01232491|Secondary|Rate of All Treatment Emergent Hypoglycaemic Episodes|Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.|||rate per year of patient exposure|||Number
1403629|NCT01232491|Secondary|Rate of Treatment Emergent Adverse Events (TEAEs)|Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26|Safety analysis set includes all subjects who received at least one dose of insulin detemir.|||rate per 100 years of patient exposure|||Number
1403630|NCT01232491|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
1403631|NCT01232491|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1403632|NCT01232491|Secondary|Change From Baseline in Body Mass Index (BMI)|Estimated mean change from baseline in BMI after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||kg/m^2||Standard Error|Least Squares Mean
1403633|NCT01232491|Primary|Change From Baseline in Body Weight|Estimated mean change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Error|Least Squares Mean
1403634|NCT01232465|Primary|Pregnancy|detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth|9 months||||participants|||Number
1403635|NCT01232452|Secondary|Immunogenicity of Cixutumumab||Preinfusion, Cycle1(C1): 1, 72, 168, 240, 336 hours(hrs); C2 and C3: 1, 168, 336 hrs; C4: 1, 24,72,120,168, 240, 336, 504 hrs, Postinfusion; 30 Day Follow Up|Zero participants were analyzed due to no immunogenicity analysis was done and the assay was never developed.||||||
1403636|NCT01232452|Secondary|Pharmacodynamics (PD) Markers: Free Insulin-like Growth Factor-I (IGF-I, Total IGF-I, and IGF Binding Proteins (IGFBP-3)|Blood samples for the determination of PD marker concentrations were collected at the specified time points for all participants. Analysis of the following markers include free IGF-I, total IGF-I, and IGFBP-3.|Preinfusion, Cycle 2, Cycle 4, Cycle 8, Postinfusion, 30-Day Follow-Up|Zero participants were analyzed for PD Biomarker IGF-I, total IGF-I, and IGFBP-3 due to blood samples were not collected in order to assess biomarker data.||||||
1403637|NCT01232452|Secondary|PK: Area Under the Concentration Time Curve During 1 Dosing Interval (i.e. 504 hr, AUC(0-tau) of Cixutumumab, Cycle 4 (i.e. Fourth Infusion)||Prior to Infusion (of Cycle 4), 1, 24, 72, 120, 168, 240, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5)|Participants who were randomized to the cixutumumab arm and had evaluable PK data.|||(ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1403638|NCT01232452|Secondary|PK: Area Under the Concentration Time Curve (AUC[0-inf]) of Cixutumumab, Cycle 1 (i.e. First Infusion)||Prior to Infusion (of Cycle 1), 1, 72, 168, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 2)|Participants who were randomized to the cixutumumab arm and had evaluable PK data.|||microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1403639|NCT01232452|Secondary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Cixutumumab, Cycle 1 (First Infusion) and Cycle 4 (Fourth Infusion)||First Infusion: [Prior to Infusion (of Cycle1): 1, 72, 168, 336 hours(hrs) and 504 hrs (i.e. Prior to Infusion of Cycle 2)] and Fourth Infusion; [Prior to Infusion (of Cycle 4),1,24,72,120,168,240,336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5)]|Participants who were randomized to the cixutumumab arm and had evaluable PK data.|||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
1403640|NCT01232452|Secondary|Change in Tumor Size (CTS)|CTS was measured by percentage change of tumor size at the end of Cycle 2 comparing to baseline tumor size.|Change from baseline measurement to the end of Cycle 2, average of 42 days|All randomized participants.|||Percent Change||Standard Deviation|Mean
1403641|NCT01232452|Secondary|Time to Worsening of Symptoms as Measured by Lung Cancer Symptom Scale (LCSS) Score|TTPS was defined as the time from the date of randomization until the date of worsening of symptoms as measured by Lung Cancer Symptom Scale (LCSS) score. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI) that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale – ranging from 0 to 100 where higher score indicates worst outcome). For each participant, the maximum improvement over baseline score was calculated for each of the 9 LCSS items, ASBI and LCSS total score. Participants without event are censored at the date of the last LCSS assessment. TTPS was estimated using the Kaplan-Meier method.|Time to worsening of symptoms as measured by LCSS score Up to 18.3 Months|All randomized participants. Participants censored in Cixutumumab arm = 38 and Pemetrexed + Cisplatin arm = 46.|||Months||95% Confidence Interval|Median
1403670|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|40 weeks|||||||
1403642|NCT01232452|Secondary|Time to Progressive Disease (TTPS)|TTPS was defined as the time from the date of randomization until the date of disease progression. Disease progression was assessed via RECIST version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing non-target lesions.TTPS was estimated using the Kaplan-Meier method.|Randomization Date to Disease Progression Up to 18.3 Months|All randomized participants. Participants censored in Cixutumumab arm = 39 and in the Pemetrexed + Cisplatin arm = 36.|||Months||95% Confidence Interval|Median
1403643|NCT01232452|Secondary|Duration of Response (DOR)|Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for PD is met, or death, is objectively documented. DOR was estimated using the Kaplan-Meier method. Disease progression was assessed via RECIST version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing non-target lesions|Time from Response to Disease Progression or Death from Any Cause Up to 20 Months|All randomized participants who had CR or PR. Participants censored in Cixutumumab arm = 10 and Pemetrexed + Cisplatin arm = 8.|||Months||95% Confidence Interval|Median
1403644|NCT01232452|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. OS was estimated using the Kaplan-Meier method.|Randomization Date to Death From Any Cause Up to 20 Months|All randomized participants. Participants censored cixutumumab arm = 47 and pemetrexed + cisplatin arm = 39.|||Months||95% Confidence Interval|Median
1403645|NCT01232452|Secondary|Percentage of Participants Achieving an Objective Response Rate (ORR)|The ORR is the percentage of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. ORR is confirmed best overall tumor response of CR and PR. CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.|Randomization to Disease Progression Up to 18.3 Months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1403646|NCT01232452|Primary|Progression-free Survival (PFS)|PFS was defined as the time from date of randomization until the date of disease progression, or death from any cause, whichever was first. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation for disease progression or death were censored at the date of last tumor assessment. The PFS was estimated following the Kaplan-Meier method.|Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months|All randomized participants. Participants censored in Cixutumumab arm = 20 and Pemetrexed + Cisplatin arm = 21.|||months||95% Confidence Interval|Median
1403647|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of AUCtau Following a Single Dose of TKI258|The mean AUC from time zero to the last measurable concentration sampling time (t last) (mass x time x volume-1)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile|||(ng.h/mL)||Standard Deviation|Mean
1403648|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Tmax Following a Single Dose of TKI258|Tmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Tmax is the time to to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after a single dose administration (time)|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile|||hours||Full Range|Median
1403649|NCT01232296|Secondary|Pharmacokinetic (PK) Parameter of Cmax Following a Single Dose of TKI258|Cmax will be evaluated after a single dose of TKI258 following a 5 days on/2 days off dosing schedule. Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after a single dose administration (mass x volume - 1).|Week 1 day 1, week 4 day 5|The Full-PK analysis set: all patients who were selected for full PK sampling and provided at least one evaluable PK concentration profile|||(ng/mL)||Standard Deviation|Mean
1403650|NCT01232296|Secondary|Time to Definitive Deterioration in ECOG Performance Status (PS)|Time to definitive deterioration on ECOG PS scale (by at least one point) was defined as the time from the date of randomization to the date of definitive deterioration of the ECOG PS by at least one category of the score from baseline or to the date of death whichever occurred earlier. 0 is Fully active, able to carry on all pre-disease performance without restriction, 1 is Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work and 2 is ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first|The Full Analysis Set (FAS): all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure. Only Total number of definitive deterioration events included in the analysis|||Weeks||95% Confidence Interval|Median
1403675|NCT01232127|Primary|Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1403651|NCT01232296|Secondary|Disease Control Rate (Tumor Assessment)|Disease Control Rate (DCR) is defined as the proportion of patients whose best overall response is either complete response [CR], partial response [PR] or stable disease [SD] according to RECIST 1.1.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.|||Participants|||Number
1403652|NCT01232296|Secondary|Time to Tumor Progression (Tumor Assessment)|Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). For target lesions, disease progression mean at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression refers to unequivocal progression of existing non-target lesions. In addition, the appearance of new lesions is always considered as disease progression.|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.|||Weeks||95% Confidence Interval|Median
1403653|NCT01232296|Primary|Overall Survival - Overall Survival|The overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient was not known to have died at the date of analysis cut-off, OS was censored at the last date of contact. Survival information was collected every 6 wks until at least 130 deaths have been observed|Every 6 weeks from date of randomization until the patient has progressed, or the patient can no longer be followed, or at least 130 deaths have been observed in the study, whichever came first.|The Full Analysis Set (FAS) comprises of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment (and strata) they were assigned to during the randomization procedure.|||Weeks||95% Confidence Interval|Median
1403654|NCT01232283|Secondary|Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 260|The apremilast subjects as treated population, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.|||participants|||Number
1403655|NCT01232283|Secondary|Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260|The Apremilast-exposure Period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. Adverse events that started after 28 days of initiating placebo and before resuming apremilast treatment in the Randomized Treatment Withdrawal Phase (Weeks 32 to 52) were excluded in the Apremilast-exposure phase. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 260; The mean duration of exposure was 100.66 weeks.|Apremilast participants as treated, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.|||participants|||Number
1403656|NCT01232283|Secondary|Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 16|Safety population, included all participants who were randomized and received at least one dose of IP. Participants with a PASI ≥ 125% of Baseline score after last dose who did not have psoriasis rebound captured as a Treatment Emergent Adverse Event.|||participants|||Number
1403671|NCT01232127|Secondary|Number of Participants With Abnormalities in Laboratory Test Results|PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN.|Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
1403657|NCT01232283|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Baseline to Week 16|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)|||participants|||Number
1403658|NCT01232283|Secondary|Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment with loss of 50% PASI improvement (event), or the time between the re-randomization date and the date of the last PASI assessment in the randomized withdrawal phase prior to addition of topical/phototherapy or other effective psoriasis therapies, or resumption of apremilast 30 mg BID, or discontinuation, or Week 52 if no loss (censored), whichever was earlier|Weeks 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or Apremilast 30mg BID at Week 32.|||Weeks||95% Confidence Interval|Median
1403659|NCT01232283|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline|"PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome measure #1 for further description.~sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See Outcome Measure #2 for further description."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
1403660|NCT01232283|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|"The SF-36 was a 36-item general health instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS).~Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value."|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
1403661|NCT01232283|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16|DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant’s skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from “Very Much” (score 3) to “Not at All” or “Not relevant” (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant’s skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if “No,” then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being “A lot,” “A little,” or “Not at all” (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included|||units on a scale||Standard Error|Least Squares Mean
1403662|NCT01232283|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
1403672|NCT01232127|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett’s and Fridericia’s formulae), and Investigator-identified ECG abnormalities.|Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
1403663|NCT01232283|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||Percentage of Participants|||Number
1403664|NCT01232283|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline and Week 16|FAS consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||percent change||Standard Error|Least Squares Mean
1403665|NCT01232283|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA) at Week 16|"BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint” including the fingers), which equates to approximately 1% of total body surface area.~BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA – baseline BSA) / baseline BSA (%)."|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.|||percent change||Standard Error|Least Squares Mean
1403666|NCT01232283|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator must have factored in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
1403667|NCT01232283|Primary|Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at week 16. The improvement in PASI score was used as a measure of efficacy. The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used. .|||percentage of participants|||Number
1403668|NCT01232205|Primary|Preeclampsia|Preeclampsia was defined as gestational hypertension (systolic pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg [Korotkoff V] on ≥ 2 occasions after 20 weeks gestation) with proteinuria (> 0.3 g/day). Severe preeclampsia was defined by the presence of >1 of the following: (a) severe gestational hypertension (systolic pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg on 2 occasions after gestational week 20), or (b) severe proteinuria (≥5g protein in a 24-h urine specimen or ≥3 g in 2 random urine samples collected ≥4 h apart)|9 months||||participants|||Number
1403669|NCT01232205|Secondary|Cell-free mRNA|Secondary outcome were level of mRNA level of angiogenic factors (vascular endothelial growth factor receptor-1 (VEGFR-1), placental growth factor (PlGF) and endoglin(ENG)); antioxidant status (FRAP, heme oksigenase-1 (HO-1) and superoxide-dismutase (SOD))|40 weeks|||||||
1403673|NCT01232127|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir||Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and had adequate PK profiles.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1403676|NCT01232127|Secondary|Number of Participants With Abnormalities in Vital Signs|Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate.|Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
1403677|NCT01232127|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.|Participants who received study drug and were evaluable.|||Participants|||Number
1403678|NCT01231984|Secondary|Number of Serious, Unexplained Hyperglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hyperglycemic events in his/her diary anytime his/her blood glucose (BG) was above 400mg/dL, or s/he required medical attention for treatment for hyperglycemia.~Hyperglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hyperglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject missed an insulin dose). Subjects were asked to record these events in a diary."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hyperglycemic events.|||Adverse Events|||Number
1403679|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 12.7 mm)|"Subjects’ glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.~Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 12.7 primary analysis due to protocol deviations. The total population size evaluated for this analysis is therefore 113.|||HbA1c (%)||Standard Deviation|Mean
1403680|NCT01231984|Secondary|Number of Serious, Unexplained Hypoglycemic Events, Reported as Number of Events by Needle.|"Subjects were asked to record hypoglycemic events in his/her diary anytime his/her blood glucose (BG) was below 50mg/dL, s/he had signs/symptoms of hypoglycemia, or s/he required medical attention for treatment.~Hypoglycemia was defined as serious when the subject required the assistance of another person to be treated, or when the hypoglycemic event met the per-protocol definition of a Serious Adverse Event. An unexplained episode was defined as one with no known cause (for example, the subject skipped a meal or exercised vigorously)."|During Study Period 1 (12 weeks) and Study Period 2 (12 weeks)|Two hundred seventy-four subjects were randomized into the study. Data from all subjects randomized were included in the analysis of subjects with serious, unexplained hypoglycemic events.|||Adverse Events|||Number
1403681|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 12 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a negative pain rating means the period 2 needle was perceived as less painful than the period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 12 mm study arm completed all main study visits. One of the subjects was excluded from all primary and secondary analyses due to protocol deviations.|||mm||Standard Error|Mean
1403682|NCT01231984|Secondary|Injection Pain Scores (4 mm vs. 8 mm)|"At the end of second study period, subjects were asked to rate the level of pain experienced with study period 2 needle compared to the pen needle used in study period 1, using a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used in Period 1. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm); therefore a pain rating < 0 indicates that the Period 2 needle was perceived as less painful than the Period 1 needle."|At the end of Study Period 2|115 subjects in the 4mm vs. 8 mm study arm completed all main study visits. Two of the 115 subjects were excluded from all primary and secondary analyses due to protocol deviations. The total number of subjects analyzed for perceived pain for this study was therefore 113.|||mm||Standard Error|Mean
1403683|NCT01231984|Secondary|Glycemic Control as Measured by HbA1c, in High Dose Insulin (at Least One Dose of ≥ 40 Units) Users|Glycemic control was assessed as by difference between the subjects' HbA1c (%) at baseline (randomization, Visit 3) and at the end of each 12 week study period,in the same manner as for the primary outcome measures. The 95% confidence interval for the mean difference in HbA1c values between the 4mm PN and the longer PN will be estimated based on general linear models adjusting for baseline HbA1c.|Subjects were randomly assigned to use the BD Ultra-Fine™ 4mm pen needle for one - 12 week study period and either the BD Ultra-Fine™ 8mm pen needle or the BD Ultra-Fine™ 12.7mm pen needle for one - 12 week study period.|Of the 226 subjects who were considered for the Primary analysis, 107 subjects had at least one dose of insulin that was at least 40 units. The glycemic control of this sub-group of subjects was analyzed as in the Primary Analysis.The same analysis was performed for the high insulin dose subjects, with the two longer PN study arms pooled together.|||HbA1C (%)||Standard Deviation|Mean
1403701|NCT01231620|Secondary|Median Quantity of Oxygen Delivery Measured at Baseline (Day 1) and During the Study|Oxygen delivery were assessed three times daily at Baseline (Day 1) and during the treatment period/hospitalization (ideally at least 6 hours apart) and once daily during inpatient/hospitalization and once at Post +5 days, +16 days, and +28 days clinic visits. The median quantity of oxygen delivery during the study was not summarized since the data was not collected in a way to accurately calculate values. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and during the study|This end point was not analyzed||||||
1403684|NCT01231984|Primary|Glycemic Control as Measured by HbA1c (4 mm vs. 8 mm)|"Subjects’ glycemic control was assessed by comparing hemoglobin A1c (HbA1c) levels measured at the end of each 12 week Study Period (e.g., at Visit 5 or Visit 7) to the HbA1c measured at the start of that Study Period, i.e. the baseline (Visit 3) for Period 1 and the Period 1/2 crossover (Visit 5) for Period 2.~Analysis included only subjects with HbA1C values at baseline (Visit 3) and at the end of Study Period 1 (Visit 5) and end of Period 2 (Visit 7)."|Over each 12 week study period|115 subjects completed all main study visits. Two subjects were excluded from the 4 vs. 8 primary analysis due to protocol deviations. The total population size evaluated for the primary objective (4 vs. 8) is therefore 113.|||HbA1c (%)||Standard Deviation|Mean
1403685|NCT01231841|Secondary|Reduction of VB Repertoire Associated With r-ATG/CsA Combination|We will perform molecular analysis of the TCR repertoire to identify “marker” immunodominant clone specimens using VB typing.|Every 4 weeks|||||||
1403686|NCT01231841|Secondary|Comparison of the Level of IS as Assessed by Immuknow Assay in Responders and Non-responders||Every 2 weeks for 3 months beginning on day 1 of therapy and then monthly (for a total of 6 months)|||||||
1403687|NCT01231841|Primary|Patients Treated With Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) Achieving at Least a Partial Remission (PR) at 6 Months|Patients will be classified as responders if they have transfusion independence and meet two of the following three criteria: ANC greater than 500/mm3; platelet count greater than 20,000/mm3; and reticulocyte count greater than 40,000/mm3. Transfusion independence is defined as no need for transfusions for one month prior to response assessment.|At 6 months||||participants|||Number
1403688|NCT01231750|Primary|Severity of Angina Was Measured.|Severity of angina was measured using numerical score 1 to 10, where 10 is the worst intensity and 1 is the least.|Application was 45 minutes prior to exercise|||||||
1403689|NCT01231750|Primary|Magnitude of Reversible Perfusion Defect in SPECT With Wall Motion Assessment (Phase 2)|Phase 2 of the study involving nuclear imaging was not done because the study was stopped early for lack of enrollment.|Phase 2 was not done.|||||||
1403690|NCT01231750|Primary|Maximal Estimated Workload (in METS)|Maximal estimated workload (in METS) was measured during exercise tolerance test (ETT).|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
1403691|NCT01231750|Primary|Maximal ST Depression|Exercise ECG data was reviewed by a board certified cardiologist to assess maximal ST depression.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
1403692|NCT01231750|Primary|Time-to-onset of Angina or Angina Equivalent Symptoms|Onset of angina or angina-equivalent symptoms was assessed from beginning of exercise.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
1403693|NCT01231750|Primary|Time-to-onset of 1mm ST Segment Depression|Continuous ECG was recorded during exercise. ECG was reviewed by a board-certified cardiologist.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
1403694|NCT01231750|Primary|Symptom-limited Exercise Duration as an Indicator of Exercise Capacity|Subjects walked on the treadmill as long as they could tolerate, symptom-limited.|Application was 45 minutes prior to exercise|Data collected are no longer accessible.||||||
1403695|NCT01231646|Primary|Levels of Folate Receptor Autoantibodies|ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.|On the same day after informed consent was obtained||||ug/mL||Standard Deviation|Mean
1403696|NCT01231633|Secondary|Change in Central Mean Thickness Based on OCT|Change in Central Mean Thickness based on OCT from baseline to Month 6t|Baseline to 6 Months||||Microns on OCT||Full Range|Mean
1403697|NCT01231633|Primary|The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm|Total Number of addiitonal Avastin injections during study- From baseline to Month 6|Baseline - Month 6||||Injections||Full Range|Mean
1403698|NCT01231633|Primary|The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm|The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm|Baseline - Month 6||||Letters Gain/Loss||Full Range|Mean
1403699|NCT01231620|Secondary|Serum Concentration of IV Zanamivir|Pharmacokinetic samples were collected at four time points to characterize peak concentration (end of infusion; C[EOI]) after the first dose on Day 1 and on Day 4 to characterize the pre-dose concentration (C[0]), the peak concentration C(EOI), and the trough concentration at 11-12 hours post-dose (C[12]) of zanamavir. Data was summarized by Creatinine clearance (CL) Category. The dose on Day 1 is the initial dose (unadjusted) and the dose on Day 4 is the maintenance dose.|Day 1 and Day 4|Pharmacokinetic (PK) Population comprised of all participants who received IV zanamivir and underwent sparse PK sampling during the study from which one or more serum zanamivir concentrations was determined. This outcome was not analyzed for participants receiving oseltamivir 75 mg. Only the participants available at the time point were analyzed.|||microgram/Liter (mcg/L)||Standard Deviation|Mean
1403700|NCT01231620|Secondary|Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) and Day 4|On Baseline/Day 1, a 12-lead ECG was obtained within approximately 24 hours prior to dosing. The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. In the original protocol ECGs were also done on Day 4, however, amendment 2 removed this requirement and therefore not all participants had Day 4 ECGs.|Baseline (Day 1) and Day 4|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1403927|NCT01229722|Primary|Pill Count|During the clinic visits ever 3 weeks over the course of the study, participants will be asked to bring all their pill bottles and count the contents of each bottle with assistance from the study coordinator. This count will be compared with the refill history for that patient from the pharmacy in order to get a sense of how many pills they have taken.|every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012|||||||
1403702|NCT01231620|Secondary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and up to 42 days|Safety Population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1403703|NCT01231620|Secondary|Number of Participants With the Indicated Treatment-emergent (TE) Grade (G) 3/4 Clinical Chemistry Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatine kinase, chloride, CO2/bicarbonate, creatinine, potassium, magnesium and sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and up to 42 days|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1403704|NCT01231620|Secondary|Number of Participants With the Indicated Hematology Values Shifts From Baseline (Day 1) and up to 42 Days|Blood samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), S/R Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and white blood cell (WBC) count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range for the indicated hematology parameters is summarized. Baseline is defined as the pre-dose value collected on Study Day 1.|Baseline (Day 1) and up to 42 days|Safety Population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1403705|NCT01231620|Secondary|Number of Participants With the Indicated Chemistry Laboratory Values Shifts From Baseline (Day 1) and up to 42 Days|Samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), switch/rescue (S/R) Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino tranferase (AST), total bilirubin, calcium, creatine kinase, chloride, carbon dioxide content (CO2), creatinine, potassium, magnesium, sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range are summarized.|Baseline (Day 1) and up to 42 days|Safety Population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1403706|NCT01231620|Secondary|Number of Participants With Any Severe or Grade 3/4 Treatment-related AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assessed by the Investigator as related or not related to the study treatment.|Up to 42 days|Safety Population|||Participants|||Count of Participants
1403707|NCT01231620|Secondary|Number of Participants Who Were Permanently Discontinued From the Study Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.|Up to 42 days|Safety Population|||Participants|||Count of Participants
1403708|NCT01231620|Secondary|Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.|Up to 42 days|Safety Population|||Participants|||Count of Participants
1403709|NCT01231620|Secondary|Number of Participants With Any Severe or Grade 3/4 AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of AEs. Grade 3=severe; Grade 4=potentially life threatening.|Up to 42 days|Safety population|||Participants|||Count of Participants
1403928|NCT01229722|Primary|Self-Report|During the clinic visits ever 3 weeks over the course of the study, participants will be asked to recall what pills they took and what they missed.|every 3 weeks, for the 6 month duration of the third user study, from October 2011 through March 2012|||||||
1403710|NCT01231620|Secondary|Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. All AEs were assessed by the Investigator as related or not related to the study treatment.|Up to 42 days|The Safety Population comprised of all randomized participants who received at least one dose of investigational product and assessed according to their actual treatment received, regardless of the randomization assigned.|||Participants|||Count of Participants
1403711|NCT01231620|Secondary|Number of Participants With Resistance-associated Mutations Detected in the Neuraminidase (NA) and Hemagglutinin (HA) Gene of Influenza A and B Viruses in Nasopharyngeal Swabs and Endotracheal/BAL Samples|Nasopharyngeal swabs and endotracheal /BAL samples were collected for viral susceptibility analysis. Susceptibility analyses consisted of phenotyping and genotyping. Resistance mutations were detected by genotyping. Viral susceptibility to zanamivir and oral oseltamivir at Baseline and throughout treatment determined by NA and HA (gene of influenza A and B viruses) sequence analysis and NA enzyme inhibition. Number of participants with viral mutation events are summarized, this includes all resistance mutations (substitutions) i.e. those present at Baseline and those that emerged during treatment.|Baseline (Day 1) and up to 42 days|IPP Population|||Participants|||Count of Participants
1403712|NCT01231620|Secondary|Median Time to no Detectable Viral RNA and the Absence of Cultivable Virus in Any Obtained Sample (Upper and Lower Respiratory Samples)|Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples, where available) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment). Endotracheal aspirates were collected in participants who were intubated. If treatment was continued beyond Day 5, additional samples were taken on Treatment Day 6, Day 8, Day 10, and/or the day of the last dose of randomized treatment, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R treatment. If the participant was symptomatic and hospitalized, samples were taken on the Post-treatment+2, +5, +9, +16 assessment days, and at the Post-Treatment +28 Day. Assessment of samples was done by quantitative RT-PCR.|Baseline (Day 1) and up to 42 days|IPP Population. Only those participants available at the specified time points were analyzed. Data also presented for participants positive at Baseline.|||Days||Full Range|Median
1403713|NCT01231620|Secondary|Number of Participants With no Detectable Viral RNA and the Absence of Cultivable Virus in Lower Respiratory Samples (Bronchoalveolar Lavage Sample [BAL], Endotracheal Aspirate)|Lower respiratory samples included BAL and endotracheal aspirates. Endotracheal aspirates were requested in participants (par.) who were intubated. Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment [trt]). Endotracheal aspirates were collected in participants who were intubated. If trt was continued beyond Day 5, additional samples were taken on Trt Day 6, Day 8, Day 10, and/or the day of the last dose of randomized trt, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R trt. If the par. was symptomatic and hospitalized, samples were taken on the Post-Trt +2, +5, +9, +16 assessment days, and at the Post-Trt [PT]+28 Day assessment. Assessment of samples was done by quantitative RT-PCR and viral culture.|Baseline (Day 1) and up to 42 days|IPP Population. Data is presented for participants positive at Baseline. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1403714|NCT01231620|Secondary|Change From Baseline Viral Load (Influenza A or B) by qPCR From Nasopharyngeal Swabs Positive at Baseline|Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the post-treatment +2, +5, +9, +16 and +28 day assessment. Viral load as measured by PCR. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable|IPP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles)|||log10 vp/mL||Full Range|Median
1403715|NCT01231620|Secondary|Change From Baseline in Quantitative Virus Culture From Nasopharyngeal Swabs Positive at Baseline|Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day1, S/R Day3, S/R Day5, or S/R Day6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16 and +28Day assessment. Viral load was measured by Quantitative Virus Culture, log10 50% Tissue Culture Infectious Dose (TCID50)/milliliter (mL). Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus Baseline value .|Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable|IPP Population. Only those participants available at the specified time points were analyzed.|||log10 TCID50/mL||Full Range|Median
1403757|NCT01231555|Secondary|Number of Participants Discontinuing the Study Drugs Due to AEs|Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Number of participants quitting/ prematurely discontinuing the use of study drug(s) were recorded.|Up to 20 weeks|Safety population|||Participants|||Count of Participants
1404223|NCT01227785|Primary|Clinical Performance at Implant for LV Pacing Threshold|LV pacing threshold results were reported for CRT-D patients at implant.|implant|78 CRT-D patients had data available at implant.|||volts (V)||Standard Deviation|Mean
1403716|NCT01231620|Secondary|Median Time to Virologic Improvement|Virologic improvement is defined as a 2 log drop in viral load or sustained undetectable viral ribonucleic acid (RNA) (on two successive occasions) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples. Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Days 6, 8, 10 and on the last day of randomized treatment. For participants who utilized the Switch (S)/Rescue (R) option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Nasopharyngeal swabs were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16, and +28 day assessment.|Baseline (Day 1) and up to 42 days|IPP Population. Only those participants available at the specified time points were analyzed. Data presented is for participants positive at Baseline.|||Days||Full Range|Median
1403717|NCT01231620|Secondary|Median Time to the Absence of Fever and Improved Respiratory Status, Oxygen Saturation, Heart Rate, and Systolic Blood Pressure|The absence of fever is defined as a non-axillary temperature recording <=36.6 degrees Celsius axillary, <= 37.2 degrees Celsius oral or <= 37.7 degrees Celsius core. Respiratory Status (RS) response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), or the need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate =<24 breaths/minute (without supplemental oxygen). Oxygen saturation response criteria: >=95% (without supplemental oxygen). Heart rate response criteria: =<100 beats/minute. Systolic blood pressure response criteria: >=90 millimeters of mercury. Vital signs were assessed three times daily during the treatment period/hospitalization. Vital signs were assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit.|Baseline (Day 1) and up to 42 days|IPP Population|||Days||Full Range|Median
1403718|NCT01231620|Secondary|Median Time of Duration of Hospitalization and Intensive Care Unit (ICU) Stay|Hospital duration and ICU duration was assessed from the first day of dosing. Hospital duration was calculated as the discharge date minus the admission date + 1. Hospital duration while on study was the earlier of discharge, completion, or withdrawal minus the later of the admission date or the study start date + 1. ICU duration-Modified was calculated as the original ICU duration minus ICU days prior to Study Day 1.|Day 1 to the end of the study (assessed up to 42 days)|IPP population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
1403719|NCT01231620|Secondary|Median Time of Duration of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation|Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitalization and once at each post-treatment clinic visit.|Baseline (Day 1) and up to 42 days|IPP Population. Only those participants available with the indicated ventilator support or oxygen supplementation were analyzed.|||Days||Full Range|Median
1403720|NCT01231620|Secondary|Number of Participants With the Indicated Ventilation Status: Modality of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation|"Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD), no supplemental oxygen (O2) or ventilation support, Respiratory support at “any time (AT) on study” and at Baseline (Day 1) are summarized. Data for the any time (AT) on study time point was reported."|Up to 42 days|IPP Population|||Participants|||Count of Participants
1403721|NCT01231620|Secondary|Number of Participants With Complications of Influenza and Associated Antibiotic Use|The number of participants with complications of influenza and associated antibiotic use were summarized|Up to 42 days|IPP Population|||Participants|||Count of Participants
1403722|NCT01231620|Secondary|Median Time of Duration of Clinical Symptoms of Influenza|Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient/hospitalization and once at each post-treatment assessment.|Up to 42 days|IPP Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
1403723|NCT01231620|Secondary|Number of Participants With the Indicated Clinical Symptoms of Influenza|Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient hospitalization and once at each post-treatment assessment.|Up to 42 days|IPP Population|||Participants|||Count of Participants
1403724|NCT01231620|Secondary|Median Time to Return to the Pre-morbid Level of Activity as Measured by the 3-point Scale|Median time to return to pre-morbid level of activity was assessed once daily during treatment/hospitalization and once at each post-treatment assessment and was measured using the 3- point scale (bed rest, limited ambulation, or unrestricted).|Up to 42 days|IPP Population. Participants succeeded in pre-morbid functional status were analyzed.|||Days||Full Range|Median
1403725|NCT01231620|Secondary|Number of Participants Who Returned to Their Pre-morbid Functional Status as Assessed Per the Katz ADL Score and Each ADL Activity Score at the End of the Study|Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. The number of participants who returned to their pre-morbid functional status at the end of the study assessed per the Katz ADL score (bathing, dressing, toileting, transferring, continence and feeding activities) is summarized.|Up to 42 days|IPP Population|||Participants|||Count of Participants
1403726|NCT01231620|Secondary|Median Time to Return to Pre-morbid Functional Status as Measured by the Katz ADL Score and Each ADL Activity Score|Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. Median time to return to pre-morbid functional status was assessed via the Katz ADL score (bathing, dressing, toileting, transferring, continence, and feeding activities). For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent.|Up to 42 days|IPP population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
1403727|NCT01231620|Secondary|Change From Baseline in the Katz Activities of Daily Living (ADL) Score and Each ADL Activity Score|The Katz ADL scores were collected for bathing, dressing, toileting, transferring, continence, and feeding activities and were assessed once daily during the treatment period/hospitalization and once at each post-treatment Clinic Visit. For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline is defined as the difference at each time point (Day 5/6, and Day 10/11, and last day S/R if treatment was extended beyond 5 days) and the end of the study (post-treatment [PT] +28 Days) compared to Baseline.|Baseline (Day 1) and up to 42 days|IPP population. Only those participants available at the specified time points were analyzed.|||Scores on the scale||Standard Deviation|Mean
1403728|NCT01231620|Secondary|Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit|The number of participants who died on or before Day 14, Day 28, and the End of Study Visit were summarized.|On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days)|IPP Population|||Participants|||Count of Participants
1403729|NCT01231620|Secondary|Percentage of Participants With Respiratory Improvement|Respiratory Status (RS) is a component of TTCR. Response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), a need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate of =<24 breaths/minute (without supplemental oxygen). Data are presented as the percentage of participants achieving respiratory improvement.|Up to 42 days|IPP Population|||Percentage of participants|||Number
1403730|NCT01231620|Primary|Time to Clinical Response (TTCR) in Participants With Confirmed Influenza|Clinical response is defined as the resolution of at least 4 of the 5 vital signs (temperature, oxygen saturation, respiratory status, heart rate, systolic blood pressure) within the respective resolution criteria, maintained for at least 24 hours, or hospital discharge, whichever occurred first. This analysis was performed for Influenza positive population, for those with symptom onset less than or equal to (<=) 4 days, and for those on mechanical (mech) ventilation or in intensive care unit (ICU).|Up to 42 days|ITT-E population comprised of all randomized participants who received at least one dose of investigational product. The Influenza positive population (IPP) is comprised of all participants in the ITT-E population with proven influenza infection.|||Days to success||95% Confidence Interval|Geometric Mean
1403731|NCT01231607|Secondary|Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24|Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15).|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
1403732|NCT01231607|Secondary|Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24|"Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: Since the start of treatment, when I look at my thinning area, I can see..., Since the start of treatment, my hair now covers…, and Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is… -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9)."|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
1403733|NCT01231607|Secondary|Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
1403734|NCT01231607|Secondary|Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)|Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment).|Week 12, Week 24, and Week 26|ITT Population. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1403735|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 24 (W24). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.|||participants|||Number
1403976|NCT01229410|Primary|Highest Vitreous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.|60 Days|Per Protocol: all subjects with pharmacokinetic data available|||Nanogram/milliliter (ng/mL)|||Number
1403736|NCT01231607|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12)|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 12 (W12). v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex."|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. The number of participants analyzed reflects the sum of the participants with the three BL stages.|||participants|||Number
1403737|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: –3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
1403738|NCT01231607|Secondary|Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately|The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: –3 = greatly decreased, –2 = moderately decreased, –1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
1403739|NCT01231607|Secondary|Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 24 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline with those subsequently obtained at Week 24. This assessment was made separately based on the global photography of the vertex and frontal views.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||scores on a scale||Standard Error|Least Squares Mean
1403740|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
1403741|NCT01231607|Secondary|Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 μm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on the hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
1403742|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||millimeters||Standard Error|Least Squares Mean
1403784|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403743|NCT01231607|Secondary|Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT|The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value.|Baseline, Week 12, and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed.|||millimeters||Standard Error|Least Squares Mean
1403744|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.|||Hair count||Standard Error|Least Squares Mean
1403745|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value.|Baseline and Week 12|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed.|||Hair count||Standard Error|Least Squares Mean
1403746|NCT01231607|Secondary|Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
1403747|NCT01231607|Primary|Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)|The primary target area HC was based on the nonvellus hair (>=30 micrometers [μm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed.|||Hair count||Standard Error|Least Squares Mean
1403748|NCT01231581|Secondary|Number of Participants With Change From Baseline Increase to Grade 3/Grade 4 in Lab Hematology Test Measurements|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The CTCAE version 3.0 displays Grades 1 through 5, with unique clinical descriptions of the severity for each toxicity based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.|||participants|||Number
1403749|NCT01231581|Secondary|Number of Participants (Par.) With a Worst-case Change to Grade 3 or Grade 4 From Baseline Grade in Chemistry Parameters|A grading (severity) scale is provided for each laboratory toxicity. Grade refers to the severity of the toxicity. The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 displays Grades 1 through 5 based on the general guideline: Grade 1, mild toxicity; Grade 2, moderate toxicity; Grade 3, severe toxicity; Grade 4, life-threatening or disabling toxicity; Grade 5, death related to toxicity.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 17-April-2012 (up to 17 months)|Safety Population. Only those par. with laboratory values for worst-case on therapy were analyzed. The same par. were not necessarily analyzed for each laboratory parameter; thus, the number of par. analyzed reflects all par. in the Safety Population. The number of par. analyzed for a particular parameter is included in the parameter title.|||participants|||Number
1404224|NCT01227785|Primary|Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1month|68 CRT-D and 43 ICD patients had data available at 1month visit.|||milli volt (mV)||Standard Deviation|Mean
1403750|NCT01231581|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Per protocol other events were considered SAEs like symptomatic left ventricular ejection fraction (LVEF) decreases or cases of central serous retinopathy (CSR) or retinal vein occlusion (RVO). AE and SAE data were collected from the start of the first dose of study treatment and continued until 28 days following discontinuation of the study treatment or death. Refer to the general AE/SAE module for a complete list of AEs and SAEs.|From the start of the first dose of study treatment until 28 days following discontinuation of the study treatment or until the data cutoff of 15-March-2013 (up to 21 months)|Safety Population: all participants who were randomized and took at least one dose of study medication. This population was based on the actual treatment received, if it differed from that to which the participant was randomized.|||participants|||Number
1403751|NCT01231581|Secondary|Investigator-Assessed Duration of Response|Duration of response is defined, for the subset of participants with a CR or PR, as the time from the first documented evidence of CR or PR until the first documented disease progression or death due to any cause. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start).|From the first documented CR or PR until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 13 months)|MD Population. Duration of response was assessed for only those participants with a CR or PR.|||Weeks||95% Confidence Interval|Median
1403752|NCT01231581|Secondary|Number of Participants With an Investigator-assessed Best Response, With or Without Confirmation, of Complete Response (CR) or Partial Response (PR)|CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g., percent change from baseline). CR and PR were evaluated by the Investigator using standard criteria (RECIST version 1.1). Confirmation of response was not required.|From randomization until disease progression or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|Measurable Disease (MD) Population: all randomized participants regardless of whether or not treatment was administered who had measurable disease at baseline|||participants|||Number
1403753|NCT01231581|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of radiological PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). PD was also based on unequivocal progression of existing non-target lesions. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, or did not have a documented date of progression or death, PFS was censored at the last adequate assessment.|From randomization until disease progression (PD) or death due to any cause or until the data cutoff of 17-April-2012 (up to 15 months)|ITT Population|||weeks||95% Confidence Interval|Median
1403754|NCT01231581|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who were not dead at the time of analysis; such participants were considered censored.|From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered|||months||95% Confidence Interval|Median
1403755|NCT01231555|Secondary|Minimum and Maximum Plasma GSK2248761 Concentration at Week 2|"Maximum observed plasma concentration and minimum observed plasma concentration of GSK2248761 was recorded on Week 2. The PK parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Pro 4.1 or higher. Log transformed values have been presented.~All calculations of non-compartmental parameters were based on actual sampling times."|At Week 2|The PK Concentration Population included all participants who received GSK2248761, underwent intensive and/or limited PK sampling during the study, and provided evaluable GSK2248761 plasma concentration data. Only the participants available at the time of assessment were analyzed.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1403756|NCT01231555|Secondary|Number of Participants With Changes in Electrocardiogram (ECG) From Baseline (Day 1) Over 16 Weeks|The QTc interval was assessed by two methods Bazzette's method (QTc[b]) and Federica's method (QTc[f]). Baseline value was recorded at Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Change from Baseline values were categorized into <30 milliseconds (msec), >=30 but <60 msec, and >=60 msec. The data has been presented for QTcB and QTcF for participants prior to switching the therapy.|Baseline (Day 1) to 16 weeks|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination.|||Participants|||Count of Participants
1404095|NCT01227993|Secondary|Change in Serum DHT Levels at Two Years Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in picograms of DHT per milliliter of serum.|Baseline and 2 years||||pg/mL||Standard Deviation|Mean
1403758|NCT01231555|Secondary|Number of Participants With HIV Disease Progression|Number of participants acquiring clinical disease progression or death during the treatment period were presented. Clinical disease progression was defined as the progression from Baseline (Day 1) HIV disease status in either of these categories; CDC Category A at baseline to CDC Category B event, CDC Category A at baseline to CDC Category C event, CDC Category B at baseline to CDC Category C event, CDC Category C at baseline to new CDC Category C event, CDC Category A, B or C at baseline to death. If no change occurs, it was termed as no disease progression.|Up to 20 Weeks|ITT-E population.|||Participants|||Count of Participants
1403759|NCT01231555|Secondary|Number of Participants With HIV Associated Conditions|HIV associated condition included recurrence of previous conditions. Centre for disease control (CDC) associated conditions and non-CDC associated conditions were planned to be monitored.|Up to 20 Weeks|ITT-E population.|||Participants|||Count of Participants
1403760|NCT01231555|Secondary|Change From Baseline (Day 1) in Plasma HIV-1 RNA Over Period|For summaries and analyses which use HIV-1 RNA level as a continuous measure, the logarithm to base 10 of the value was used. In cases where a sample was retested, the retest value was used. Baseline was defined as the value recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Data for participants prior to switch and after the switch has been presented.|Baseline (Day 1) up to Week 16|ITT-E population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination.|||log10 copies per milliliter||Standard Deviation|Mean
1403761|NCT01231555|Primary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 20 Weeks|Safety population included all randomized participants who were exposed to the study drug(s) with the exception of any participant with documented evidence of not having consumed any amount of the study drug.|||Participants|||Count of Participants
1403762|NCT01231555|Primary|Number of Participants With Plasma HIV-1 RNA Below 50 Copies/mL as a Function of Viral Load|This analysis was based on the Missing, Switch or Discontinuation equals Failure (MSDF) algorithm (as codified by the FDA’s “snapshot” algorithm) and was adjusted for stratification factors and stage of recruitment. Dose selection was based primarily on antiviral activity and tolerability in conjunction with immunologic, safety, virologic resistance and pharmacokinetic (PK) measures. The efficacy decision criteria was based on an observed difference of >=8% between the two GSK2248761 dosage arms.|Up to Week 16|Intent to treat exposed (ITT-E) population included all randomized participants who received at least one dose of study drug. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm due to early termination. Only those participants available at indicated timepoints were analyzed.|||Participants|||Count of Participants
1403763|NCT01231516|Secondary|DTG PK Parameters Including AUC(0-tau)|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48.|Week 4, Week 24, and Week 48|PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed.|||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1403764|NCT01231516|Secondary|DTG PK Parameters Including Cmax, Cmin, C0, and C0_avg|The maximal concentration (Cmax), and the minimal concentration (Cmin) were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 as well as the average C0 (C0_avg) , Cmax and Cmin were estimated and reported here.|Week 4, Week 24, and Week 48|"PK Concentration Population: all participants who received DTG, underwent sparse PK sampling during the study, and provided evaluable DTG plasma concentration data. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X."|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1403765|NCT01231516|Secondary|Number of Participants With the Indicated Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. .|From Baseline until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study|Safety Population: all participants who received at least one dose of IP (i.e., DTG or RAL)|||Participants|||Number
1403766|NCT01231516|Secondary|Number of Participants With Indicated Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.|From Baseline (Day 1) until Week 48|mITT-E Population|||Participants|||Number
1403767|NCT01231516|Other Pre-specified|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value data for CD8+ cell count (cells per millimeters cubed [mm^3]) were only reported on a per-participant basis and were not summarized.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|mITT-E Population||||||
1403768|NCT01231516|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline (BL), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40 and Week 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 32, 40, and 48|"mITT-E Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each visit is indicated by n=X, X."|||cells/mm^3||Inter-Quartile Range|Median
1403769|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment."|Week 24, Week 48|mITT-E Population|||Participants|||Number
1403770|NCT01231516|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24|"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis."|Week 24|mITT-E Population|||Participants|||Number
1403771|NCT01231516|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent INI Resistance at Time of Protocol Defined Virology Failure (PDVF)|For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|Baseline until PDVF up to Week 48|mITT-E Population|||Participants|||Number
1403772|NCT01231516|Primary|Percentage of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) at Week 48|"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study."|Week 48|Modified Intent-To-Treat Exposed (mITT-E) Population: all randomized participants who received at least one dose of IP excluding four participants at one site, which was closed due to Good Clinical Practice (GCP) non-compliance issues in another ViiV sponsored trial.|||Percentage of participants|||Number
1403773|NCT01231503|Other Pre-specified|Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations|Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.|At Month 18 post vaccination|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||mIU/mL||95% Confidence Interval|Geometric Mean
1403774|NCT01231503|Other Pre-specified|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.|At Month 18 post vaccination|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1403775|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403776|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn’t receive any vaccination at this time point|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403777|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403778|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 10 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403779|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403780|NCT01231503|Secondary|Number of Subjects Reported With Solicited General Symptoms|Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403781|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Month 9 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403782|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn’t receive vaccination at this time point.|Within 7 days (Days 0-6) after Week 26 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403783|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 14 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403785|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 6 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403786|NCT01231503|Secondary|Number of Subjects Reported With Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. “Any” about a specific symptom is defined as incidence of this symptom, regardless of its intensity.|Within 7 days (Days 0-6) after Week 0 vaccination|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403787|NCT01231503|Secondary|Concentrations of Antibodies Against Measles Antigens|"Concentrations of anti measles antibodies were determined by ELISA and expressed as GMCs in milli-international units per millilitre (mIU/mL).~The seropositivity cut-off value for the assay was ≥ 150 mIU/mL. Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups."|At Month 10|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||mIU/mL||95% Confidence Interval|Geometric Mean
1403788|NCT01231503|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT)|Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was ≥ 15 EL.U/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1403789|NCT01231503|Secondary|Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations|Anti-Polio 1, 2 and 3 antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in international units per mililiter (IU/mL) and tabulated. The seroprotection cut-off value for the assay was ≥ 8 IU/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals and did not take any immune modifying medication or had blood transfusions.|||IU/mL||95% Confidence Interval|Geometric Mean
1403790|NCT01231503|Secondary|Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations|Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off value for the assay was ≥ 0.15 µg/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||µg/mL||95% Confidence Interval|Geometric Mean
1403791|NCT01231503|Secondary|Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations|Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off value for the assay was ≥ 0.1 IU/mL.|At Month 5|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||IU/mL||95% Confidence Interval|Geometric Mean
1403792|NCT01231503|Secondary|Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-off values for the assay were greater than or equal to (≥) 6.2 and 10 mIU/mL, respectively.|At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||mIU/mL||95% Confidence Interval|Geometric Mean
1403793|NCT01231503|Secondary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was greater than or equal to (≥) 0.5 EL.U/mL.|At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1403801|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M10 for RTS,S 14-26-9M Group|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1403794|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter|This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal WBC level was defined as > 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as < 1.0 Billions WBC/L.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403795|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter|This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects’ levels were assessed as either normal, Grade (G) 1, G2, G3, G4 or Missing. Normal PLA level was defined as > 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as < 25 Billions PLA/L.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403796|NCT01231503|Secondary|Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter|This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects’ levels were assessed as either normal, Grade (G) 1, G 2, G 3, G 4 or Missing. Normal HAE level was defined as HAE > 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE < 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE < 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE < 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE < 7.0 g/dL.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403797|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter|This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403798|NCT01231503|Secondary|Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter|This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects’ levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal ALT level was defined as ALT< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as > 10.0 times the ULN.|At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1403799|NCT01231503|Secondary|Number of Subjects Reported With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity.|From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.|||Participants|||Count of Participants
1403800|NCT01231503|Secondary|Number of Subjects Reported With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group.|During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.|||Participants|||Count of Participants
1404265|NCT01227629|Secondary|11-dehydrothromboxane B2 (TXB2): Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability|||pg/mg Creatinine||Standard Deviation|Mean
1403802|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groups|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1403803|NCT01231503|Primary|Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.|At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups|Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1403804|NCT01231503|Primary|Number of Subjects Reported With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. “Any” is defined an incidence of a SAE regardless of intensity/severity.|From study start at Month 0 up to Month 10.|Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.|||Participants|||Count of Participants
1403805|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living|The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.|||Points on a scale||Standard Error|Least Squares Mean
1403806|NCT01231464|Secondary|Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy|The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.|Baseline through end of study (Day 1 through Day 15/Early Withdrawal)|FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.|||Points on a scale||Standard Error|Least Squares Mean
1403807|NCT01231464|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)|The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.|Baseline through entire treatment period (Day 1 through Day 14)|Full Analysis Set (FAS): all participants who were randomized and received at least one dose of study medication. Only participants for whom both baseline and post-baseline data were available were included in this analysis.|||Points on a scale||Standard Error|Least Squares Mean
1403808|NCT01231412|Secondary|Number of Participants With Relapse/Progression|"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL, MDS >5% blasts by morphologic or flow cytometric evaluation of the BMA or appearance of extramedullary disease CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or numb"|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1403809|NCT01231412|Secondary|Overall Survival|Number of subjects surviving post-transplant.|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1403810|NCT01231412|Secondary|Incidences of Non-relapse Mortality|Number of subjects expired without disease progression/relapse.|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1403811|NCT01231412|Secondary|Incidences of Grade III-IV Acute GVHD|"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Up to 100 days|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1403812|NCT01231412|Secondary|Incidences of Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.|Up to 1 year|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1403813|NCT01231412|Primary|Incidences of Acute Grade II-IV GVHD, Exclusive of GVHD That Occurs as a Result of Alterations to Immunosuppressive Therapy in Response to Relapse or Progression|"Number of patients who developed acute GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|At day 100 post-transplant|One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1403814|NCT01231399|Primary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of death from any cause.|Up to 5 years.||||Months||95% Confidence Interval|Median
1403815|NCT01231399|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 5 years||||Months||95% Confidence Interval|Median
1403816|NCT01231399|Primary|Number of Subject With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years||||participants|||Number
1403817|NCT01231399|Primary|Maximum Tolerated Dose (MTD) of Everolimus|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Course 1 (first 28 days)|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg|||Number
1403818|NCT01231373|Secondary|Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance|The Independent Photography Review--Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians, evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (0-4, where 0=none and 4=very severe visible varicose veins).|8 weeks||||units on a scale||Standard Error|Least Squares Mean
1403819|NCT01231373|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|"The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram fo the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from Not at all noticeable (a score of 0) to Extremely noticeable (a score of 4)."|8 weeks|patients with a baseline and week 8 visit.|||units on a scale||Standard Error|Mean
1403820|NCT01231373|Primary|Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)|The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). At Visit 2/baseline, Week 8, scores were calculated.|8 weeks|Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit.|||units on a scale||Standard Error|Least Squares Mean
1403821|NCT01231334|Primary|Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator at Baseline and Week 12. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules/nodules are round, solid elevations of the skin with no visible fluid. The percentage of participants with at least a one point decrease (improvement) in GAAS was calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percentage of participants|||Number
1403822|NCT01231334|Secondary|Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12|The investigator rated the patient's current symptoms of erythema, dryness, peeling, and oiliness on a 5 point scale from 0 (Absent) to 4 (Severe). The investigator rated the symptoms of pruritus and burning since last visit on a 6 point scale of 0 (Absent) to 5 (Severe)-interfering with daily activities. Percentage of participants demonstrating a ≥1 category increase (improvement) in tolerability from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percentage of participants|||Number
1403823|NCT01231334|Secondary|Percent Change From Baseline in Total Lesion Count at Week 12|Percent change in total lesion counts: inflammatory (papules, pustules and nodules) and non-inflammatory (comedones) lesion counts from baseline. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters ) and nodules are larger (greater than 5 or 10 millimeters). Pustules are small elevations of the skin containing cloudy material. Comedones are small bumps on the skin caused by acne and found at the opening of a skin pore. A negative change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percent change||Full Range|Median
1403824|NCT01231334|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12|"Percent Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percent change||Full Range|Median
1403825|NCT01231334|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts at Week 12|Percent Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percent change||Full Range|Median
1403826|NCT01231334|Secondary|Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity|The overall disease severity was evaluated by the investigator at Baseline and Week 12 using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. The percentage of participants with at least a one point decrease (improvement) from baseline is calculated.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Percentage of participants|||Number
1403827|NCT01231334|Secondary|Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12|GAAS was conducted by the investigator. The patient's facial acne was evaluated on a 5 point scale 0=None (no evidence of acne), 1=Minimal (few lesions), 2=Mild (several to many non-inflammatory lesions; few inflammatory lesions), 3=Moderate (many lesions) to 4=Severe (Significant degree of inflammatory disease; papules/pustules present, few nodulo-cystic lesions; comedones may be present). Papules and nodules are round, solid elevations of the skin with no visible fluid. A negative change from baseline indicates improvement.|Baseline, Week 12|Per-Protocol Population consists of all randomized participants who completed the study to week 12 without any major protocol violation.|||Score on a scale||Standard Deviation|Mean
1403828|NCT01231321|Secondary|Change in Disease Activity Score (DAS28) Compared With Baseline|The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease).|Baseline and 24 weeks|All subjects with data available from both Baseline and Week 24 were included in this intent-to-treat (ITT) analysis.|||units on a scale||Standard Deviation|Mean
1403829|NCT01231321|Primary|Vital Sign Values|"Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory.~Note, in table, BP = blood pressure."|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis.|||participants|||Number
1403830|NCT01231321|Primary|Deviation From Normal Laboratory Ranges|"Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory.~Note abbreviations used in table:~Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate"|24 weeks|All subjects with available data were included in this intent-to-treat (ITT) analysis. The number of subjects with available data is indicated for each laboratory assessment.|||participants|||Number
1403853|NCT01230788|Primary|Toxicities of Rituximab|To describe the toxicities of rituximab in addition to prednisone, etoposide, and ifosfamide.|two months after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
1403831|NCT01231321|Primary|Changes of Physical Examination|Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.|Baseline and 24 weeks|All enrolled subjects with available data were included in this intent-to-treat (ITT) analysis.|||participants|||Number
1403832|NCT01231321|Primary|Frequency of Adverse Events|"Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported.~Note:~Severe events considerably interfered in patients' usual activities and may have been life-threatening.~Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness."|Up to 34 weeks (24 week study treatment plus 70-day follow-up period)|All enrolled subjects were included in this intent-to-treat (ITT) analysis.|||participants|||Number
1403833|NCT01231230|Primary|Maximum Change From Baseline in Airway Blood Flow (Qaw)||maximum change in Qaw within 240 minutes post drug inhalation||||change from baseline ( µl/min/ml)||Standard Error|Mean
1403834|NCT01230892|Primary|Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS|Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)|1 year|4 subjects either withdrew or were lost to follow-up and not included in analysis population. Additionally, one subject in the Atenolol arm was removed from analysis population due to IVUS occurring in the incorrect artery and one subject in the Nebivolol arm was removed due to the IVUS catheter malfunctioning.|||participants|||Number
1403835|NCT01230827|Secondary|Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48|Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
1403836|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48|Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes.|Week 16 through Week 48|ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
1403837|NCT01230827|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48|Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
1403838|NCT01230827|Primary|Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48|Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate.|Week 16 through Week 48|Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16.|||Percentage of Participants|||Number
1403839|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel’s Criteria).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV by clinical criteria (Amsel's criteria).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
1403854|NCT01230788|Primary|4 Month Event Free Survival (EFS)|To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one year after enrollment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
1403840|NCT01230814|Secondary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for any of three vaginal infections (BV, VVC, Trichomonas vaginalis infection).|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
1403841|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for BV as determined by applying standard microscopic scoring criteria (Nugent’s criteria) to vaginal Gram stained slides. BV is diagnosed when the score is greater than or equal to 7.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
1403842|NCT01230814|Primary|Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC).|Percentage of follow-up visits (Months 2, 4, 6, 8, 10, 12) positive for VVC based on the presence of fungal elements (pseudohyphae, blastoconidia, or both) on vaginal saline wet mount plus a positive culture showing yeast on Sabouraud’s agar.|Months 2, 4, 6, 8, 10, and 12.|Intention to treat population which consisted of all women who were randomized and had at least one follow-up visit. Two women in the metronidazole with miconazole arm did not return after enrollment.|||percentage of follow-up visits|Participants|95% Confidence Interval|Number
1403843|NCT01230801|Other Pre-specified|Change From Baseline in Upright Maximum Ventilatory Volume|Change from Baseline in Upright Maximum Ventilatory Volume. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point. No patient had baseline assessment in group of BMN 701 5 mg/kg.|||L/min||Standard Deviation|Mean
1403844|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Upright Maximum Inspiratory Pressure|Change from Baseline in Percent Predicted Upright Maximum Inspiratory Pressure. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point. No patient had baseline assessment in group of BMN 701 5 mg/kg.|||percentage of Predicted MIP||Standard Deviation|Mean
1403845|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Upright Maximum Expiratory Pressure|Change from Baseline in Percent Predicted Upright Maximum Expiratory Pressure. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point. No patient had baseline assessment in group of BMN 701 5 mg/kg.|||percentage of Predicted MEP||Standard Deviation|Mean
1403846|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Supine Forced Vital Capacity|Change from Baseline in Percent Predicted Supine Forced Vital Capacity. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point.|||percentage of Predicted Supine FVC||Standard Deviation|Mean
1403847|NCT01230801|Other Pre-specified|Change From Baseline in Percent Predicted Upright Forced Vital Capacity|Change from Baseline in Percent Predicted Upright Forced Vital Capacity. Changes in respiratory function were assessed by measurement of MEP, MIP and MVV; and percent predicted upright and supine FVC.|Baseline up to 24 week|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point.|||percentage of Predicted Upright FVC||Standard Deviation|Mean
1403848|NCT01230801|Secondary|Change From Baseline in Six Minutes Walk Test|Change from Baseline in Six Minutes Walk Test. The 6MWT measured the maximum distance the subject could walk on a flat, hard surface in a period of 6 minutes|Baseline up to 24 weeks|ITT Population. As some patients did not attend or all tests were not completed at each visit, some time points had different numbers of patients analyzed. The total number of patients analyzed for each arm is listed as the maximum patients analyzed at any given time point.|||meter||Standard Deviation|Mean
1403849|NCT01230801|Primary|Number of Participants With Adverse Events|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|24 weeks|Safety Population|||Participants|||Count of Participants
1403850|NCT01230788|Secondary|Prednisone Effect|To correlate the effect of prednisone on CD20 expression using serial measurements of CD20 expression in leukemic blasts.|one month after treatment|||||||
1403851|NCT01230788|Secondary|Minimal Residual Disease|To perform serial minimal residual disease (MRD) measurements to provide an objective determination of the effectiveness of this therapy.|one month after treatment|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
1403852|NCT01230788|Primary|Remission Induction Rate|To estimate the remission induction rate of the addition of rituximab to cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.|one month|The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.||||||
1403855|NCT01230749|Secondary|Change From Baseline to Day 29 in Body Weight|Difference is calculated as the change in body weight in Least Square Mean (LSM) from baseline to Day 29 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 29|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||Kilograms||Standard Error|Least Squares Mean
1403856|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP)|Difference is calculated as the geometric mean change in CRP from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. CRP was not measured for pioglitazone group.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||mg/dL||Standard Deviation|Geometric Mean
1403857|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18)|Difference is calculated as the geometric mean change in IL-18 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-18 was not measured for pioglitazone group. The unit of IL-18 is picograms per milliliter (pg/mL)|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||pg/mL||Standard Deviation|Geometric Mean
1403858|NCT01230749|Secondary|Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6)|Difference is calculated as the geometric mean change in IL-6 from baseline to Day 28 of each treatment group (JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the geometric mean change. IL-6 is a systemic inflammatory markers and is an independent predictors of insulin resistance and progression to type 2 diabetes mellitus. IL-6 was not measured for pioglitazone guoup. The unit of IL-6 is picograms per milliliter (pg/mL).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||pg/mL||Standard Deviation|Geometric Mean
1403859|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Resistance|Difference is calculated as the change in insulin resistance in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insuline sensitivity is measured by absolute change in Homeostasis Model Assessment of insulin resistance (HOMA-IR). Insulin sensitivity is HOMA-%S and HOMA-IR is the reciprocal of HOMA-%S. HOMA-IR calculated as: (Glucose [mg/dL]) multiplied by Insulin [pmol/L]) divided by (405 multiplied by 6.945). Lower value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-IR was not collected on Day 28.|||HOMA-IR score||Standard Error|Least Squares Mean
1403860|NCT01230749|Secondary|Change From Baseline to Day 28 in Insulin Secretion|Difference is calculated as the change in insulin secretion in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. Insulin secretion is measured by the absolute change in Homeostasis Model Assessment of steady state islet beta cell (HOMA-%B). HOMA-%B calculated as: (360 multiplied by Insulin [pmol/L]) divided by ([Glucose {mg/dL} minus 63] multiplied by 6.945). Higher value is better (signifies improvement relative to baseline).|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for HOMA-%B was not collected on Day 28.|||HOMA-B score||Standard Error|Least Squares Mean
1403861|NCT01230749|Secondary|Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG)|Difference is calculated as the change in FPG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change.|From baseline to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment. Two participants (1 in JNJ-41443532 250-mg group and 1 in Pioglitazone group) were excluded from the analysis because a blood sample for FPG was not collected on Day 28.|||mg/dL||Standard Error|Least Squares Mean
1403862|NCT01230749|Primary|Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG)|Difference is calculated as the change in 24-hour WAG in Least Square Mean (LSM) from baseline to Day 28 of each treatment group (pioglitazone, JNJ-41443532 250 mg, JNJ-41443532 1000 mg, and placebo). The statistical analyses shows the treatment differences (ie, each study medication group minus placebo) in the LSM change. 24-hour WAG is defined as the area under the plasma glucose concentration time curve over 0 to 24 hours, divided by 24.|From baseline (Day -1) to Day 28|Analyses included all participants who received at least 1 dose of JNJ-41443532 or placebo and had at least 1 pharmacodynamic assessment posttreatment.|||mg/dL||Standard Error|Least Squares Mean
1403873|NCT01230424|Secondary|Change in Time to Complete 5 Chair Stands.|Change in time (seconds) to complete 5 chair stands. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||seconds||95% Confidence Interval|Mean
1403874|NCT01230424|Secondary|Change in Time to Complete a Twenty-meter Walk.|Change in time (seconds) to complete a twenty-meter walk. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||seconds||95% Confidence Interval|Mean
1404266|NCT01227629|Secondary|Soluble Fibrin: Difference From Baseline|Difference from baseline to visit 7|baseline and 12 weeks|All randomised patients, only per-protocol data included.|||µg/ml||Standard Deviation|Mean
1403863|NCT01230710|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.|||Percentage of participants|||Number
1403864|NCT01230710|Secondary|Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)|A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants. The analysis only included 47 participants as data for 4 participants was not available.|||Percentage of participants|||Number
1403865|NCT01230710|Secondary|Overall Survival|Overall survival was defined as the time from the date of enrolment to the date of death from any cause.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.|||Days||Inter-Quartile Range|Median
1403866|NCT01230710|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment until the end of the study (up to 2 years, 6 months).|Full analysis set: All enrolled participants.|||Days||95% Confidence Interval|Median
1403867|NCT01230710|Primary|Percentage of Participants With Progression-free Survival at Week 52|A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.|From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).|Full analysis set: All enrolled participants.|||Percentage of participants|||Number
1403868|NCT01230593|Secondary|Chalazion Size Difference Post-Treatment|Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment|baseline and 4-6 weeks|Intention to treat population|||millimeters||Standard Deviation|Mean
1403869|NCT01230593|Primary|Number of Participants With Complete Resolution|Defined as number of patients with chalazion size regression of 100%|4-6 weeks|Intention to treat population|||participants|||Number
1403870|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.~Reference intervals include:~Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|12 months post enrollment/randomization||||mL/min/1.73 sqm||Standard Deviation|Mean
1403871|NCT01230502|Primary|Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)|"This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.~Reference intervals include:~Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm"|6 months post enrollment/randomization||||mL/min/1.73 sqm||Standard Deviation|Mean
1403872|NCT01230489|Primary|Time From Catheter Implantation to First Exit Site Infection.|The outcome measure is the length of time from implantation until the patient has first exit site infection or two years which ever is shortest.|Two years|Data is unavailable as no analysis has occurred. The study was terminated to due loss of communication between the surgical and research departments.||||||
1403875|NCT01230424|Secondary|Change in Patient's Global Assessment (Visual Analogue Scale).|"The response to the question, Considering all the ways your knee affects you, how much pain are you having today?, was measured and the change in the scoring was evaluated. The Patient's Global Assessment (PGA) is measured on a scale of 0 to 100 millimeters. Higher scores represent a higher level of disease activity or a worse global health. Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm||95% Confidence Interval|Mean
1403876|NCT01230424|Secondary|Change in Knee Stiffness During the Past 48 Hours From the WOMAC LK3.1 Stiffness Score Questionnaire.|"Stiffness subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Stiffness subscale score was used for this outcome measure. The Stiffness subscale consists of two items, each ranging from 0 to 4, making the total Stiffness subscore 0 to 8. Higher scores represent higher levels of stiffness, whereas lower scores represent lower levels of stiffness.~Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||units on a scale||95% Confidence Interval|Mean
1403877|NCT01230424|Secondary|Change in Function Severity During the Past 48 Hours From the WOMAC LK3.1 Function Score Questionnaire.|"Physical Function subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Physical Function subscale score was used for this outcome measure. The Physical Function subscale consists of 17 items, each ranging from 0 to 4, making the total Function subscore 0 to 68. Higher scores represent higher levels of difficulty performing daily activities, whereas lower scores represent lower levels of difficulty performing daily activities.~Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||units on a scale||95% Confidence Interval|Mean
1403878|NCT01230424|Secondary|Change in Volumetric Cartilage Damage Index (CDI) Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).|Change in volumetric cartilage damage index (CDI) measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm^3||95% Confidence Interval|Mean
1403879|NCT01230424|Secondary|Change in Area of Denudation Measured on Knee MRI in the Index Compartment (Compartment With the Most Damage).|Change in area of denudation measured on knee MRI in the index compartment (compartment with the most damage). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm^2||95% Confidence Interval|Mean
1403880|NCT01230424|Secondary|Change in Effusion Volume Measured on Knee MRI.|Change in effusion volume measured on knee MRI on the log scale. Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||log mm^3||95% Confidence Interval|Mean
1403881|NCT01230424|Secondary|Change in Volume of Peri-articular Bone Marrow Lesions Measured on Knee MRI.|Change in volume of peri-articular bone marrow lesions measured on knee MRI on the log scale. Missing data were imputed.|Baseline to 2 years.|All individuals were included in analysis, which was performed on multiply imputed data.|||log mm^3||95% Confidence Interval|Mean
1403882|NCT01230424|Primary|Change in Knee Pain Severity During the Past 48 Hours From the WOMAC LK3.1 Pain Score Questionnaire.|"Pain subscale score was calculated from patient's responses on the Western Ontario and McMaster Universities Osteoarthritis Index Likert-type 3.1 Questionnaire. The questionnaire includes 24 items divided into 3 subscales, Pain, Stiffness, Physical Function. Only the Pain subscale score was used for this outcome measure. The Pain subscale consists of five items, each ranging from 0 to 4, making the total Pain subscore 0 to 20. Higher scores represent higher levels of pain, whereas lower scores represent lower levels of pain.~Missing data were imputed."|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||units on a scale||95% Confidence Interval|Mean
1403883|NCT01230424|Primary|Change in Mean Cartilage Thickness in the Index Compartment (Compartment With the Most Damage)|Mean cartilage thickness was measured on knee MRI (Philips Achieva X-Series 3.0 Tesla scanner). Missing data were imputed.|Baseline to 2 years|All individuals were included in analysis, which was performed on multiply imputed data.|||mm||95% Confidence Interval|Mean
1403884|NCT01230307|Secondary|Vitamin D Genomics|Genotyped for the restricted fragment length polymorphism at the BsmI site. In addition CYP2R1, CYP27B1, CYP24 will also be genotyped.|Baseline|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity, in addition there is significant time and costs associated with this measurement which would result in data that would lead to no conclusions, this outcome was not analyzed.||||||
1403885|NCT01230307|Secondary|Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire|Kansas City Cardiomyopathy Questionnaire for quality of life is measured on a scale of 0 - 100, with 100 being best.|6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.||||||
1403886|NCT01230307|Secondary|Exercise Capacity Measured by 6 Minute Walk Test||6 months|Because enrollment was less than 30% of original goal (6 vs 4 patients) and therefore would not have scientific validity and no conclusions could be determined, this outcome was not analyzed.||||||
1403887|NCT01230307|Primary|Biomarkers|Biomarkers - C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a), propeptide procollagen type I, plasma procollagen III, matrix metalloproteinase 2 (MMP-2), MMP-9 and tissue inhibitor of matrix metalloproteinases-1 (TIMP-1).|6 months|Because enrollment was less than 30% of original goal (6 vs 4 subjects) and therefore would not have scientific validity and would be a waste of financial resources, this outcome was not analyzed.||||||
1403903|NCT01230021|Secondary|Percentage of Subjects With One or More Adverse Events (AEs) Recorded||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||percentage (%) of subjects|||Number
1404267|NCT01227629|Secondary|D-dimer: Difference From Baseline|Difference in D-dimer from baseline to last available value|baseline and 12 weeks|All randomised patients, only per-protocol data included.|||ng/ml||Standard Deviation|Mean
1403888|NCT01230177|Primary|Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])|"DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.~DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission."|12 weeks||||percent change||Standard Deviation|Mean
1403889|NCT01230177|Secondary|Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values|"On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation."|12 weeks|The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).|||participants|||Number
1403890|NCT01230177|Secondary|Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values|"On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation."|12 weeks|The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).|||participants|||Number
1403891|NCT01230177|Primary|Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])|"DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.~DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission."|12 weeks||||Score||Standard Deviation|Mean
1403892|NCT01230177|Primary|Number of Participants With Treatment Related Adverse Events|Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.|12 weeks|The safety analysis population consisted of the participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.|||participants|||Number
1403893|NCT01230060|Primary|Visual Acuity|Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.|120-180 days (visit 4)|All non missing implanted eyes, consistent set|||Participants|||Number
1403894|NCT01230021|Secondary|Physical Examination (Evaluated as Normal/Abnormal)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||participants|||Number
1403895|NCT01230021|Secondary|Vital Signs - Blood Pressure (Systolic and Diastolic)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||mmHg||Standard Deviation|Mean
1403896|NCT01230021|Secondary|Vital Signs - Pulse||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||beats/minute||Standard Deviation|Mean
1403897|NCT01230021|Secondary|Clot Solubility Test (Evaluated as Normal/Abnormal)|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||participants|||Number
1403898|NCT01230021|Secondary|Coagulation Related Parameters - Prothrombin Time (PT) (Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||Sec||Standard Deviation|Mean
1403899|NCT01230021|Secondary|Coagulation Related Parameters - Activated Partial Thromboplastin Time (aPTT, Seconds)||Day 0 and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||Sec||Standard Deviation|Mean
1403900|NCT01230021|Secondary|Coagulation Related Parameters - Fibrinogen||Day 0 and at day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||g/L||Standard Deviation|Mean
1403901|NCT01230021|Secondary|Percentage of Subjects With Development of Anti-rFXIII Antibodies, Including Inhibitors (Neutralising Antibodies Against Factor XIII)||At screening and day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||percentage of subjects|||Number
1403902|NCT01230021|Secondary|Percentage of Subjects With One or More Serious Adverse Events (SAEs)||From day 0 to day 30|Safety analysis population including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||percentage of subjects|||Number
1403904|NCT01230021|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state (Vss) is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Steady state is achieved when all variables are constant in spite of ongoing processes.|At steady state|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||mL/kg||Standard Deviation|Mean
1403905|NCT01230021|Secondary|Total Plasma Clearance (CL)|The total plasma clearance is a measure of the elimination of a drug from the body. Drugs are excreted primarily by the kidneys into the urine. Clearance is calculated as ‘CL=Dose / AUC0-30 days’).|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||mL/h/kg||Standard Deviation|Mean
1403906|NCT01230021|Secondary|Mean Residence Time (MRT)|The mean residence time (MRT) of a drug in the body and related functions are derived for drugs which are intravenously administered.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||hours||Standard Deviation|Mean
1403907|NCT01230021|Secondary|Terminal Half-life (t½)|Time point when half of the maximum plasma concentration is reached.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||hours||Full Range|Mean
1403908|NCT01230021|Secondary|Maximum Plasma Concentration (Cmax) for FXIII|Maximum plasma concentration of the drug reached.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||U/mL||Standard Deviation|Mean
1403909|NCT01230021|Secondary|Area Under the Concentration vs. Time Curve (AUC0-∞)|A measure of exposure.|From day 0 to day 30|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||IU*h/mL||Standard Deviation|Mean
1403910|NCT01230021|Primary|Area Under the Concentration vs. Time Curve (AUC)|A measure of the exposure. Blood samples for the PK assessment were drawn pre-dose and up to 30 days after dosing. The PK of FXIII in children was assessed after a single i.v. dose of rFXIII 35 IU/kg.|At pre-dose, 30 minutes, 24 hours, 7, 14, 21 and 30 days after dosing|The full analysis set including all 6 children exposed to FXIII. All 6 children were exposed to one dose of trial product.|||IU*h/mL||Standard Deviation|Mean
1403911|NCT01229943|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|From registration to time of death, assessed up to 3 years||||months||95% Confidence Interval|Median
1403912|NCT01229943|Secondary|Overall Response Rate|The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.|Up to 3 years||||percentage of participants|||Number
1403913|NCT01229943|Primary|Progression Free Survival|Progression Free Survival (PFS) was defined as the time from study entry until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions (and an absolute increase of at least 0.5 cm) or the appearance of new lesions.|From study entry to the date of documented progression or death from any cause, up to 3 years||||months||95% Confidence Interval|Median
1403914|NCT01229891|Secondary|Serum High Density Lipoprotein (HDL)||12-week||||mg/dL||Standard Deviation|Mean
1403915|NCT01229891|Secondary|Serum Low Density Lipoprotein (LDL)||12-week||||mg/dL||Standard Deviation|Mean
1403916|NCT01229891|Secondary|Serum Total Cholesterol (Tchol)||12-week||||mg/dL||Standard Deviation|Mean
1403917|NCT01229891|Secondary|Serum Triglyceride (TG)||12-week||||mg/dL||Standard Deviation|Mean
1403918|NCT01229891|Secondary|Hemoglobin A1c (HbA1c)||12-week||||percent||Standard Deviation|Mean
1403919|NCT01229891|Secondary|Insulin|fasting serum insulin concentration|12-week||||mU/L||Standard Deviation|Mean
1403920|NCT01229891|Secondary|Fasting Serum Glucose (FSG)||12-week||||mg/dL||Standard Deviation|Mean
1403921|NCT01229891|Primary|Serum 25-hydroxyvitamin D||12-week||||nmol/L||Standard Deviation|Mean
1403922|NCT01229735|Secondary|Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52||From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the SS who returned at least 1 postbaseline seizure diary.|||responders|||Number
1403923|NCT01229735|Secondary|Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52|Reduction from baseline was defined as baseline value minus post-baseline value and therefore is the negative of the change from baseline value.|From Baseline to Week 52|The Full Analysis Set (FAS) consists of all subjects in the Safety Set (SS) who returned at least 1 postbaseline seizure diary.|||percent reduction||Inter-Quartile Range|Median
1403924|NCT01229735|Secondary|Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.|||month||Inter-Quartile Range|Median
1403925|NCT01229735|Secondary|Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52||From Baseline to Week 52|The Safety Set (SS) consists of all subjects who were randomized and received at least 1 (partial) dose of study medication.|||Participants|||Number
1403926|NCT01229735|Primary|Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate||From Baseline to Week 52|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who returned at least 1 post-baseline seizure diary.|||percentage of subjects|||Number
1404225|NCT01227785|Primary|Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|73 CRT-D and 44 ICD patients had data available at pre-discharge visit.|||milli volt (mV)||Standard Deviation|Mean
1403929|NCT01229722|Primary|Adherence to Anti-retroviral Therapy|MEMS pill caps or boxes will be used to monitor adherence. Each participant will place the drug containing the protease inhibitor, or, if no such drug is being taken, the drug with the highest dosing frequency, inside of a MEMS device, which automatically records each time the pillbox was opened. Participants will bring this to the clinic during their regularly scheduled visits, and those daily measurements will be downloaded to a clinic machine.|daily, for the 6 month duration of the third user study, from October 2011 through March 2012||||percentage adherence||Standard Deviation|Mean
1403930|NCT01229527|Secondary|Patient's Satisfaction|The degree of satisfaction about the quality of sedation was measured with VAS (Visual Analog Scale) where 0 means no satisfaction and 100 means maximum satisfaction.|After the end of colonoscopy (when patients were completely awake) and 24 h after the procedure via telephone||||units on a scale||Standard Deviation|Mean
1403931|NCT01229527|Primary|Discharge Time, the Time to Reach a Modified Aldrete Score ≥18|Ten key parameters (Activity, Respiration, Circulation, Consciousness, O2 Saturation, Dressing, Pain, Ambulation, Fasting-feeding, Urine Output)are included in the Modified Aldrete Score. The maximum and minimum score for each parameter is respectively 2 and 0. The maximum total score is 20 and patient can be discharged when the total score is ≥18.|> 0 minutes||||minutes||Inter-Quartile Range|Median
1403932|NCT01229462|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4|Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 4|Intent-to-treat population consisted of all randomized participants.|||mm Hg||Standard Deviation|Mean
1403933|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 180 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403934|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 90 After Last Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 90 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403935|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after fourth injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403936|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403937|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403977|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers|||Fold (ratio)||95% Confidence Interval|Number
1403938|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403939|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403940|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after third injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403941|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403942|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403943|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403944|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 30 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 30 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403978|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroconversion rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
1403945|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 7 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 7 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403946|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Day 1 After First Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Day 1 after first injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403947|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for fourth injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403948|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Third Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for third injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403949|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for Second Injection|TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for second injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. ‘N’ (number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403950|NCT01229436|Secondary|Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many days since their last visit they 1) were hospitalized, 2) were in nursing home, 3) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. ‘Number of participants’ analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event.|||days||Full Range|Median
1403951|NCT01229436|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered how many times since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event.|||events||Full Range|Median
1403979|NCT01229397|Secondary|Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability||Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary|Safety population, all vaccinated subjects|||participants|||Number
1404226|NCT01227785|Primary|Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude|RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients|implant|74 CRT-D and 45 ICD patients had data available at implant|||milli volt (mV)||Standard Deviation|Mean
1403952|NCT01229436|Secondary|Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire|Dupuytren's HCRU is a questionnaire used to assess healthcare usage in participants. Participants answered whether or not since their last visit they 1) had seen any doctor, 2) used any services (including physical or hand therapy, occupational therapy, home health care therapy), 3) were treated in emergency room, 4) had outpatient/day-case surgery, 5) were hospitalized, 6) had diagnostic/therapeutic procedures or tests performed, 7) were admitted in nursing home, 8) required aids/devices to assist in their daily functioning.|Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
1403953|NCT01229436|Secondary|Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score|URAM:9-item questionnaire used to assess daily hand functionality.Participants rated their ability to perform following hand functionalities on 0 to 5 scale(0=without difficulty,5=impossible):1)washing themselves with flannel, keeping hand flat,2)washing face,3)holding bottle in one hand,4)shaking someone's hand,5)stroking/caressing someone,6)clapping,7)spreading out fingers, 8)leaning on hand,9)picking up small objects with thumb and index finger.URAM total score=sum of 9 items.Total score range=0 to 45,where higher score= higher difficulty in daily hand functionality.For each cycle, baseline value=pre-injection value reported at that cycle. For follow-up on Day 90,180 after last injection, baseline value (follow-up baseline)=pre-injection value reported at cycle 1. If response was provided to less than or equal to 4 items,URAM total score was considered missing. If response was provided to >=5 items, then average score of answered questions was imputed response to missing questions.|Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||units on a scale||Full Range|Median
1403954|NCT01229436|Secondary|Time to Recovery|Time to recovery of normal activities was defined as median number of days between the initial injection date and the date on which participant recovered to normal activities, assessed after first, second and third injection for joints that received 1 through 3 injections. If a participant did not achieve recovery to normal activities, the participant's time to recovery was defined as the median number of days between the initial injection date and the date of the participant's the last daily diary recording within the cycle.|Up to Day 30 after first, second and third injection|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||days||95% Confidence Interval|Median
1403955|NCT01229436|Secondary|Number of Days Assessed on Dupuytren’s Treatment Assessment Daily Diary Questionnaire|Dupuytren's daily diary questionnaire assessed number of days during a cycle when 1) participant was absent or sick due to treatment, 2) the work hours were reduced, 3) the job duties were modified, 4) participant was unable to participate in hobbies and 5) participant wore a splint (for participants who were fitted for a splint).|C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30|FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||days||Full Range|Median
1403956|NCT01229436|Secondary|Number of Days of Concomitant Pain Medication Usage|Amount of concomitant pain medication was assessed as the number of days participants used pain medication during the study.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure.|||days||Full Range|Median
1403957|NCT01229436|Other Pre-specified|Number of Participants With Anti-Drug Antibody (ADA)|Human serum ADA samples were analyzed for the presence or absence of anti-clostridial type I collagenase (AUX-I) and anti-clostridial type II collagenase (AUX-II) antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).|Screening, Follow-up Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
1403958|NCT01229436|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy[if urine tested positive for blood or protein]).|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.|||participants|||Number
1403959|NCT01229436|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate, radial pulse and body temperature.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.|||participants|||Number
1403960|NCT01229436|Secondary|Number of Participants With Type of Concomitant Pain Medication Used|Number of participants who took different types of analgesic medications, including acetylsalicylic acid, other analgesics (any other analgesic besides those mentioned, as approved by the investigator), aporex, codis, dihydrocodeine, fentanyl, galenic/paracetamol/codeine/, hot coldrex, metamizole, morphine, oxycodone, panadeine CO (combination of paracetamol and codeine phosphate), paracetamol, paramol-118, pregabalin, solpadeine, tramadol, ultracet, to manage pain symptoms were reported. A single participant may be represented in more than 1 category.|Screening up to Day 180 after last injection|Safety set included all participants who received at least 1 injection of Xiapex.|||participants|||Number
1403961|NCT01229436|Secondary|Physician Global Assessment of Treatment Satisfaction and Disease Severity|Physician global assessment questionnaire assessed severity of the contracture at baseline, post-injection and TS, improvement from baseline in the treated contracture at post-injection only. Physician’s rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Physicians rated participant's improvement in disease severity relative to baseline as very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse.|Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
1403962|NCT01229436|Secondary|Participant Global Assessment of Treatment Satisfaction and Disease Severity|Participant global assessment questionnaire assessed severity of the contracture at baseline, post-injection and treatment satisfaction (TS), improvement from baseline in the treated contracture at post-injection only. Participants rated disease severity as normal (no contracture), mild, moderate or severe. Overall satisfaction was rated as very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied or very dissatisfied. Participants rated their improvement in disease severity relative to baseline on a 11-point scale ranging from 0 percent (%) = no improvement to 100% = total recovery, with 10 % increment between each point. Results are reported for number of participants in each category for disease severity, TS and improvement.|Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection|FAS: participants who received >= 1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points.|||participants|||Number
1403963|NCT01229436|Secondary|Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|Finger goniometry was used to measure the angles of extension and flexion of MP and PIP joints. ROM was measured as the difference between the angle of flexion and the angle of extension of the joint. For each injection, baseline value was the ROM value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the ROM value taken closest and prior to administration of first injection in that joint. ROM was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403964|NCT01229436|Secondary|Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. Change in PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403965|NCT01229436|Secondary|Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection|TPED was defined as sum of PED in MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was TPED value taken closest and prior to administration of that particular injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). Change in TPED was reported at Day 1, 7 and 30 after each injection for fingers that received 1 through 4 injections and at Day 90, 180 after last injection, where last injection was a maximum up to fourth injection for a finger. Results are not reported for fifth injection as no finger received 5 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection|FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points.|||degrees|Participants|Full Range|Median
1404053|NCT01228175|Primary|Cigarettes Per Smoking Day|"The number of cigarettes smoked were assessed only on a smoking day, i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks."|up to 36 weeks||||Cigarettes per smoking day||Standard Deviation|Mean
1403966|NCT01229436|Secondary|Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints|PED was measured in MP and PIP joints using finger goniometry. Passive extension=angle of the joint (MP or PIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. For each injection, baseline value was the PED value taken closest and prior to administration of that particular injection. For follow-up on Day 90 and 180 after last injection, baseline value (follow-up baseline) was the PED value taken closest and prior to administration of first injection in that joint. PED was reported at Day 1, 7 and 30 after each injection for joints that received 1 through 3 injections and at Day 90 and 180 after the last injection, where last injection was a maximum up to third injection for a joint. 'Number of joints analyzed' signifies total number of MP and PIP joints analyzed for this outcome measure and 'n' signifies number of joints evaluable for this measure at given time points for the mentioned joint.|Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection|FAS: participants who received >=1 injection of Xiapex, had >=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403967|NCT01229436|Primary|Total Passive Extension Deficit (TPED) at Baseline for First Injection|TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.|Baseline for first injection|Full analysis set(FAS):participants who received at least (>=)1 injection of Xiapex,had >=1 post-injection efficacy assessment(goniometric/participant-reported). 'N’(number of participants analyzed) includes total number of participants in FAS, however actual ‘N’ for this outcome is unknown as these data were not calculated as per planned analysis.|||degrees|Participants|Full Range|Median
1403968|NCT01229423|Secondary|Percentage of Subjects Satisfied With Treatment at Week 20|Percentage of subjects satisfied with treatment at week 20 was assessed using the Treatment Satisfaction Scale response to the question “Which best describes your satisfaction with LATISSE®?” Responses were “very satisfied”, “satisfied”, “neutral”, “unsatisfied”, and “very unsatisfied.” Satisfied is defined as responses of “very satisfied” and “satisfied.”|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Percentage of Subjects|||Number
1403969|NCT01229423|Secondary|Percentage of Subjects With an Improvement in Satisfaction With Overall Eyelash Prominence at Week 20|Percentage of subjects with an improvement in satisfaction with overall eyelash prominence at Week 20. Subject satisfaction with overall eyelash prominence was assessed by response to the question “Overall how satisfied are you with your eyelashes?” Responses were based on a 5-point scale (“very unsatisfied”, “unsatisfied”, “neutral”, “satisfied”, “very satisfied”). Improvement in subject satisfaction is defined as a 1-point increase from baseline.|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Percentage of Subjects|||Number
1403970|NCT01229423|Secondary|Change From Baseline in Eyelash Intensity (Darkness) at Week 20|Change from baseline in eyelash intensity (darkness) at Week 20. Assessments made were based on the mean eyelash intensity of the upper left and right eyelashes. Intensity was measured on a scale ranging from 0 (black) to 255 (white). A negative change from baseline indicates eyelash darkening in color, and a positive change from baseline indicates eyelash lightening in color.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Units on a Scale||Standard Deviation|Mean
1403971|NCT01229423|Secondary|Change From Baseline in Eyelash Thickness at Week 20|Change from baseline in eyelash thickness at Week 20. Assessments made were based on the mean thickness of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash thickness, and a negative change from baseline indicates a decrease in eyelash thickness.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Millimeters Squared (mm^2)||Standard Deviation|Mean
1403972|NCT01229423|Secondary|Percentage of Subjects With an Improvement of at Least 1-Point in Global Eyelash Assessment (GEA) Score at Week 20|Percentage of subjects with an improvement of at least 1-point in GEA score at Week 20 from baseline. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Percentage of Subjects|||Number
1403973|NCT01229423|Primary|Change From Baseline in Eyelash Length at Week 20|Change from baseline in eyelash length at Week 20. Measurements made were based on the mean length of the upper left and right eyelashes. A positive change from baseline indicates an increase in eyelash length, and a negative change from baseline indicates a decrease in eyelash length.|Baseline, Week 20|Intent-to-Treat (ITT) included all patients enrolled in the trial who received at least one application of study drug.|||Millimeter (mm)||Standard Deviation|Mean
1403974|NCT01229410|Secondary|Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)|Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods). Plasma is the fluid portion of the blood.|60 Days|Per Protocol: all subjects with qualified pharmacokinetic samples|||Percentage of Patient Samples|Participants||Number
1403975|NCT01229410|Secondary|Highest Aqueous Humor Level of Brimonidine in the Study Eye|The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm. The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.|60 Days|Per Protocol: all subjects with pharmacokinetic data available|||Nanogram/milliliter (ng/mL)|||Number
1404054|NCT01228149|Secondary|Number of Suture Lyses|Number of suture lyses at visit 5 (week 12 after surgery)|week 12|Intention-to- treat population|||Participants|||Count of Participants
1403980|NCT01229397|Primary|Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference|Seroprotection rate|This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen|Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
1403981|NCT01229371|Primary|Immunogenicity - Seroconversion Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
1403982|NCT01229371|Primary|Immunogenicity - Seroprotection Rate|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage subjects||95% Confidence Interval|Number
1403983|NCT01229371|Secondary|Number of Participants With Local and Systemic Adverse Events|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects|||participants|||Number
1403984|NCT01229371|Primary|Immunogenicity - Geometric Mean Titer Fold Increase From Baseline|"The primary endpoints were the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997 and they were the following: 1. Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40, 2. Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40, 3. GMT of HI antibodies and fold-increase in GMT"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase||95% Confidence Interval|Number
1403985|NCT01229267|Other Pre-specified|Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to 118 days)|The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.|||Percentage of participants|||Number
1403986|NCT01229267|Primary|Percentage of Participants With One or More Serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.|Up to 28 days after vaccination 4 (up to 118 days)|The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.|||Percentage of participants|||Number
1403987|NCT01229267|Secondary|Incidence of Postherpetic Neuralgia|Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.|Up to 6 months after the onset of HZ rash (up to approximately 5 years)|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1403988|NCT01229267|Secondary|Incidence of Herpes-Zoster Complications|The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.|Up to 6 months after onset of HZ (up to approximately 5 years)|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1404092|NCT01227993|Secondary|Change in Subretinal Fluid in the Fellow Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years|||||||
1403989|NCT01229267|Secondary|Incidence of Moderate to Severe Herpes-Zoster-Associated Pain|Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.|Up to 6 months after onset of HZ (up to approximately 5 years)|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1403990|NCT01229267|Primary|Incidence of Confirmed Herpes-Zoster|Clinical criteria for suspected Herpes-Zoster (HZ) cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.|Up to approximately 5 years|The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.|||Number of cases per 1000 person years||95% Confidence Interval|Number
1403991|NCT01229254|Secondary|Steady-state C12 hr on Days 14, 18, and 21 After Weight and Amiodarone-based Dosing|Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in amiodarone, low and high weight groups|Days 14, 18, and 21 of the PK period|Full Analysis Set population, which includes all patients who received at least one dose of study treatment within 24 hours prior to steady-state (SS) blood sampling, were ≥ 90% compliant with treatment, and had at least one post SS sample. The endpoint was to summarize the SS C12 hr concentration across treatments and time points as a single arm.|||ng/mL||90% Confidence Interval|Geometric Least Squares Mean
1403992|NCT01229254|Primary|Steady-state C12 hr on Days 14, 18, and 21 After Weight-based Dosing|Betrixaban PK concentration at 12 hr on Days 14, 18, and 21 in low and high weight groups|Days 14, 18, and 21 of the PK period|Per protocol analysis set, which includes all allocated patients who received at least one dose of study treatment and who were ≥ 90% compliant with study treatment, took study treatment within 24 hours prior to steadystate blood sampling, had at least two post steady-state blood samples collected, and not on amiodarone.|||ng/mL||90% Confidence Interval|Geometric Least Squares Mean
1403993|NCT01229228|Primary|Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0|"Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|Over 0 to 12 Hours||||units on a scale||95% Confidence Interval|Least Squares Mean
1403994|NCT01229176|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|"Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.~Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.~Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants)."|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population.|||participants|||Number
1403995|NCT01229176|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1403996|NCT01229176|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1403997|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set|||percentage of subjects||95% Confidence Interval|Number
1403998|NCT01229176|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.|||percentage of subjects||95% Confidence Interval|Number
1403999|NCT01229150|Other Pre-specified|Number of Participants Who Underwent Mutational Analysis for Estimated Glomerular Filtration Rate (EGFR), Mitogen-activated Protein Kinase 1 (MEK 1), Proto-oncogene B-Raf (BRAF), and LKB1|Number of participants who underwent mutational analysis for EGFR, MEK 1, BRAF, and LKB1 was to be assessed by polymerase chain reaction (PCR).|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.||||||
1404000|NCT01229150|Other Pre-specified|Number of Participants With Overexpression of Estimated Glomerular Filtration Rate (EGFR) and c-MET|Number of participants with over expression of EGFR and c-MET was to be assessed by fluoresense in situ hybridization (FISH).|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.||||||
1404001|NCT01229150|Other Pre-specified|Phospho-ERK (p-ERK), Phospho Protein Kinase B (p-AKt) and Phosphatase and Tensin Homolog (PTEN) Expression Testing|p-ERK, p-AKt and PTEN protein expression testing was to be assessed by immunohistochemistry.|At enrollment|Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.||||||
1404002|NCT01229150|Other Pre-specified|Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells|Fold change from cycle 1 day 1 was determined by programmed cell death-1 (PD-1) expression on CD8+ T cells measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
1404003|NCT01229150|Other Pre-specified|Change in Programmed Cell Death-1 (PD-1) Expression on Tregs|Fold change from cycle 1 day 1 was determined by the PD-1 expression level on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
1404004|NCT01229150|Other Pre-specified|Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs|The fold change from cycle 1 day 1 was determined by the level of CTLA-4 expression on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
1404005|NCT01229150|Other Pre-specified|Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs|Fold change from cycle 1 day 1 was determined by TIM-3 expression level on Tregs measured by the median channel number of fluorescence intensity.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.|||Fold change||Standard Deviation|Mean
1404006|NCT01229150|Other Pre-specified|Number of Participants With Changes in a Tumor's MIB-1 (Ki-67) Rate|Changes in a tumor's MIB-1 (Ki-67) rate was to be assessed by immunohistochemistry.|At enrollment|Tumor MIB-1 (Ki-67) rate testing was not done because it was too costly.||||||
1404007|NCT01229150|Secondary|Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes|Level of p-ERK was measured by the median channel cumber of fluorescence intensity. Data are relative to the level before therapy begins(C1D1).Then we see what the level was after therapy & compare. Every value after therapy is compared to pre-therapy, & every patient is their own control. To do that, we make C1D1 equal to 1 for every patient & then compare the pERK level after therapy by looking at the fold change in pERK level.|Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)|Re: number of participants analyzed: Samples were either not drawn or could not be located. WT KRAS 1/WT KRAS 2 are missing because the effect of treatment on the Ras-Raf-MEK-ERK pathway as measured by a reduction in phosphorylated extracellular signal-regulated kinases (p-ERK) in lymphocytes was evaluated in patients with KRAS-mutated tumors only.|||participants|||Number
1404008|NCT01229150|Secondary|Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response|First the number of T cells that are CD4+ is determined by staining with an antibody to CD4 and measured in a flow cytometer. Then the number of Th17+ cells is determined by staining with an antibody to IL-17 and measured in a flow cytometer. Then the percentage of CD4+ cells that are also Th17 cells is determined as a simple ratio, i.e. Th17cells/CD4 cells. This ratio is reported here for each category of KRAS mutation status for whom we had patients.|Pretreatment - Cycle 1 Day 1|No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. For all other cohorts, the numbers analyzed indicates some samples were either not drawn or could not be located.|||Percentage of Th17 in CD4+T Cells||Standard Deviation|Mean
1404009|NCT01229150|Secondary|Overall Survival|Time between the first day of treatment to the time of death.|Up to 26 months||||Months||95% Confidence Interval|Median
1404010|NCT01229150|Secondary|Percentage of Participants With Disease Control/Stabilization|Disease control/stabilization is the percentage of participants with partial response (PR) + complete response (CR) + stable disease (SD). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions.), taking as reference the smallest sum diameters.|3 cycles or up to 84 days||||percentage of participants||95% Confidence Interval|Number
1404011|NCT01229150|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|42 months|The combination of toxicities allows for a more robust understanding of the combined therapy toxicities. The dosage of the combination of erlotinib plus AZD6244 was the same whether the pt has a KRAS mutation versus KRAS wild type. KRAS is a molecular mutation and does not change whether or not a pt has toxicities to the combination of therapies.|||Participants|||Number
1404012|NCT01229150|Primary|Objective Response|Objective response is complete response + partial response. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 37 months|There were no partial or complete responses in the KRAS mut 1 arm.|||participants|||Number
1404013|NCT01229150|Primary|Progression Free Survival|Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that's the smallest on study). In addition to the relative increase of 20% of at least 5mm. (Note: the appearance of one or more lesions is also considered progression).|2.1 to 4 months||||Months||95% Confidence Interval|Median
1404014|NCT01229111|Secondary|Identification of Factors That Predict Survival|Factors that predict survival will be identified by Cox model or extended Cox model.|Up to three years|Statistically, due to the small sample size, analysis could not be done||||||
1404015|NCT01229111|Secondary|Estimation of Overall Survival|Time of overall response|Up to 3 years|Patients that received treatment.|||Months||95% Confidence Interval|Median
1404016|NCT01229111|Secondary|Progression Free Survival|Time in months that evaluable subjects survived progression free|Up to 3 years|Patients that were evaluable for response|||Months||95% Confidence Interval|Median
1404017|NCT01229111|Secondary|Tabulation of the Toxicity Profile of the Combination Therapy|Number of patients that experienced >/= grade 3 treatment related toxicities (definite, probable, possible).|Up to 3 years|All patients that received treatment drug|||participants|||Number
1404018|NCT01229111|Primary|The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|The number of patients with a Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Up to 3 years|Patients that were evaluable|||participants|||Number
1404019|NCT01228968|Secondary|Subcutaneous Fat Volume With Manual Segmentation|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with the older manual segmentation technique.|five minutes||||cubic centimeters||Standard Deviation|Mean
1404020|NCT01228968|Primary|Visceral Fat Volume With Manual Segmentation|This is the measure of visceral fat found with our older manual segmentation method|five minutes||||cm3||Standard Deviation|Mean
1404021|NCT01228968|Primary|Visceral Fat Volume With Automated Analysis|This is the measurement of Abdominal Visceral Fat in cubic centimeters as determined with a new automated segmentation program.|five minutes||||cubic centimeters||Standard Deviation|Mean
1404022|NCT01228968|Secondary|Subcutaneous Fat Volume With Automated Analysis|This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with new automated anatomical segmentation software.|five minutes||||cubic centimeters||Standard Deviation|Mean
1404023|NCT01228929|Primary|Change in Ocular Surface Temperature (OST)|Objectively evaluate the ocular surface temperature prior to and after 30 minutes of acclimation to three different environmental conditions in a controlled-environmental chamber using thermal imaging. 10 eyes were analyzed for each group.|baseline and 30 minutes||||degree celsius|Participants|Standard Deviation|Mean
1404024|NCT01228903|Other Pre-specified|Change in Serum Uric Acid Levels From Baseline to Week 12|Serum uric acid levels were measured both at baseline and after 12 weeks|Baseline and 12 weeks||||mg/dL||Standard Deviation|Mean
1404025|NCT01228903|Secondary|Change in Oxidized Low Density Lipoprotein From Baseline to Week 12||Baseline and 12 weeks||||u/L||Standard Deviation|Mean
1404026|NCT01228903|Secondary|Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12||Baseline and 12 weeks|-4.7|||pg/mL||Standard Deviation|Mean
1404027|NCT01228903|Secondary|Change in Serum Interleukin-6 From Baseline to Week 12||Baseline and 12 weeks||||pg/mL||Standard Deviation|Mean
1404028|NCT01228903|Secondary|Change in C-reactive Protein From Baseline to Week 12||Baseline and 12 weeks||||mg/L||Standard Deviation|Mean
1404029|NCT01228903|Primary|Change in Endothelial Dependent Dilation From Baseline to Week 12|Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12|Baseline and 12 weeks||||% change||Standard Deviation|Mean
1404030|NCT01228747|Secondary|Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period|A subject with a non-missing weekly generalized tonic-clonic (GTC) baseline seizure frequency and a weekly GTC seizure frequency of zero throughout the Evaluation Period, is considered as a GTC seizure-free subject on the Evaluation Period.|Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.|||participants|||Number
1404031|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Evaluation Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Evaluation Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure.|||participants|||Number
1404032|NCT01228747|Secondary|Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period|"A subject with an at least 50 % reduction in weekly generalized tonic-clonic (GTC) seizure frequency from Combined Baseline Period to the Treatment Period is considered a GTC 50 % responder.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.|||participants|||Number
1404093|NCT01227993|Secondary|Change in Subretinal Fluid in the Study Eye as Assessed by Optical Coherence Tomography (OCT) at Two Years Compared to Baseline||Baseline and 2 years|||||||
1404033|NCT01228747|Secondary|The Percentage Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Over the Evaluation Period|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from combined baseline B over the Evaluation Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline Information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline."|From Baseline to Evaluation Period (Week 12 to Week 28)|Of the 226 subjects in the Full Analysis Set (FAS), 205 are included in the analysis of this Outcome Measure in Evaluation Period.|||Percentage Change||Standard Deviation|Mean
1404034|NCT01228747|Primary|Percentage Change From the Combined Baseline in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 28-week Treatment Period (Dose Adjustment + Evaluation Periods)|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Combined Baseline B over the Treatment Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing / unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the 28-week treatment Period.~Combined Baseline means: a 4-week Retrospective Baseline + 4-week Prospective Baseline or 8-week Prospective Baseline"|From Baseline to Week 28|Full Analysis Set consisted of all subjects in the SS who had an evaluable Baseline and at least 1 post-Baseline GTC seizure count data point for the primary efficacy analysis excluding those who had seriously violated GCP. Evaluable Baseline for the primary efficacy analysis: at least 1 GTC seizure was documented for the Combined Baseline.|||Percentage Change||Standard Deviation|Mean
1404035|NCT01228734|Secondary|Number of Subjects With Curative Surgery of Liver Metastases|The number of subjects who underwent liver metastatic surgery after start of treatment and the outcome of surgery with respect to residual tumor after surgery (R0, R1, R2, not evaluable) were summarized. In case of resection of more than one metastasis, the worst outcome of surgery defined the overall status of a subject. R0 = No residual tumor after resection (all lesions resected completely); R1 = Metastases not resected completely with microscopic residual lesions; and R2 = Metastases not resected completely with macroscopic residual lesions.|Baseline up to 209 weeks|"MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized. Here Number Analyzed signifies those subjects who were evaluable for the specified categories."|||subjects|||Number
1404036|NCT01228734|Secondary|Time to Treatment Failure (TTF)|TTF was defined as time from randomization to date of the first occurrence of radiologically confirmed PD as determined by IRC, Clinical PD according to the Investigator’s assessment (if radiological confirmation of PD by IRC was unavailable), discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death within 90 days of last tumor assessment or randomization. Subjects without event were censored on the date of last tumor assessment.|Baseline up to 277 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||months||95% Confidence Interval|Median
1404037|NCT01228734|Secondary|Best Overall Response Rate (ORR)|The Best ORR was defined as the percentage of subjects having achieved complete response (CR) or partial response (PR) according to RECIST version 1.0 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.|Baseline up to 246 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||percentage of subjects||95% Confidence Interval|Number
1404038|NCT01228734|Secondary|Overall Survival (OS) Time|OS was defined as the time (in months) from randomization to death. For subjects who were still alive at the analysis data cut-off date or who lost to follow-up, survival was censored at the last recorded date that the subject was known to be alive.|Baseline up to 277 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||months||95% Confidence Interval|Median
1404039|NCT01228734|Primary|Progression Free Survival (PFS) Time|PFS was defined as the duration (in months) from randomization until the first progressive disease (PD) observation as assessed by the Independent Review Committee (IRC) according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.0, or death due to any cause when death occurred within 90 days of randomization or the last tumor assessment, whichever was later. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of the target lesions, taking as references the smallest sum LD since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|Baseline up to 246 weeks|MITT population included all subjects with RAS wild-type tumor status who were randomized to study treatment and who received at least 1 dose of study treatment. Subjects were analyzed as randomized.|||months||95% Confidence Interval|Median
1404040|NCT01228591|Secondary|Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)|Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|Baseline|Subjects analyzed included only those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
1404094|NCT01227993|Secondary|Change in 24-hour Urine Cortisol Levels at Two Years Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in micrograms.|Baseline and 2 years||||µg||Standard Deviation|Mean
1404041|NCT01228591|Secondary|Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)|Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.|Baseline|Analysis was on those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
1404042|NCT01228591|Secondary|Subject Reported Vision Using Contact Lens User Experience (CLUE).|Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
1404043|NCT01228591|Secondary|Contact Lens Comfort Using Contact Lens User Experience (CLUE)|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.|1 week|Analysis was on those who were enrolled and completed the study.|||CLUE points||Standard Error|Least Squares Mean
1404044|NCT01228591|Primary|Visual Acuity at Time of Initial Fit|Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.|After 10-15 minutes of lens wear|Analysis is conducted on those were enrolled and completed the trial.|||LogMAR|eyes|Standard Deviation|Mean
1404045|NCT01228591|Primary|Visual Acuity One Week After Lens Wear|Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.|1 week|Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.|||LogMAR|eyes|Standard Error|Least Squares Mean
1404046|NCT01228435|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Further document the safety of this regimen. Treatment-emergent adverse events will be summarized by MedDRA coding terms and separate tabulations will be produced for treatment-emergent adverse events, treatment-emergent serious adverse events, discontinuations due to adverse events, and treatment-emergent events of at least Grade 3 severity. A treatment-emergent adverse event is defined as an adverse event that was deemed to be related to the study intervention.|2 years||||participants|||Number
1404047|NCT01228435|Primary|Response Rate|The response rate was defined as the number of patients achieving a RECIST 1.0 defined response divided by the number of patients treated and was to be calculated separately for each arm. A response by RECIST criteria means that the pre-defined target lesions (sum of the longest diameters) had to decrease by 30% or more and this response needed to be confirmed on a second scan at least 4 weeks later.|2 years||||participants|||Number
1404048|NCT01228318|Post-Hoc|CD4 T Cell Count|Immunologic response measured by CD4 T cell count by treatment arm and weeks on study.|Baseline, Week 144|This analysis includes participants with a CD4 count measurement at the time points indicated.|||cells/uL||Standard Deviation|Mean
1404049|NCT01228318|Post-Hoc|Percentage of Participants With Virological Suppression by Week 144|The percentage of participants achieving viral load suppression by study week 144. Virologic suppression was defined as HIV RNA polymerase chain reaction (PCR) (viral loads) less than 50 copies per mL.|Week 144|All participants are included in this analysis, using all available measurements of viral load.|||percentage of participants|||Number
1404050|NCT01228318|Other Pre-specified|Baseline-Adjusted Means of Dual-energy X-ray Absorptiometry (DXA)|Development of osteoporosis was assessed by examining bone mineral density (BMD) by DXA scan. Baseline-adjusted means of DXA scan Z-scores are presented for the lumbar spine (L1-L4), left hip, and femur neck. The baseline-adjusted BMD mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Bone density Z-scores tell how close to the average that a person is (adjusted for age, race, and gender). A Z-score of 0 means the value matches that of the average person. Z-score values below 0 indicate lower than average bone density while values above 0 indicate higher bone density than the average person.|Baseline, Week 144|This analysis includes participants who had a DXA scan performed at baseline and at least one additional study visit.|||Z score||95% Confidence Interval|Least Squares Mean
1404051|NCT01228318|Secondary|Baseline-Adjusted Means of Osteocalcin|Osteocalcin was evaluated to examine the inhibitory effect of single dose zoledronic acid on HAART associated changes in markers of bone turnover. Osteocalcin is released from bone during resorption and higher levels in the circulatory system indicate increased bone turnover. HIV-infected individuals are expected to have increased bone resorption. The baseline-adjusted osteocalcin mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at the Week 144 clinic visit. Baseline-adjusted means of osteocalcin at week 144 are presented.|Baseline, Week 144|Participants with osteocalcin measurements at Week 144 are included in this analysis.|||ng/ml||95% Confidence Interval|Least Squares Mean
1404052|NCT01228318|Primary|Baseline-Adjusted Means for C-terminal Telopeptide of Collagen (CTx) Levels|Serum C-terminal telopeptide of collagen (CTx) levels through week 144 were examined by evaluating the baseline-adjusted means. The baseline-adjusted CTx mean is defined as the predicted response value obtained by fitting the regression equation for each treatment arm at the mean baseline value for the 2 treatment arms. The adjusted means were estimated using analysis of covariance at each scheduled clinical visit. The expected outcome is that HIV-infected individuals will display increased indices of bone resorption (CTx) as a result of diminished bone mineral density (BMD). Lower CTx values indicate that better maintenance of bone mineral density.|Baseline, Week 12 through Week 144|Participants with CTx measurements at the indicated week are included in this analysis.|||ng/ml||95% Confidence Interval|Least Squares Mean
1404055|NCT01228149|Secondary|Change in Conjunctival Redness|"Conjunctival redness (ORA Scale) evaluated from 16 up to 28 days (time window) prior surgery and 1 day prior surgery. The investigator compares patient's study eye with a set of reference photos showing various degrees of redness. Redness was scored on a scale of none, mild, moderate, severe and very severe. Absolute and relative frequencies of visit 1 and 2 were compared descriptively."|24 weeks|ITT population|||Participants|||Count of Participants
1404056|NCT01228149|Secondary|Change in Quality of Life|"Change in quality of life measure by a certified National Eye Institute Visual Functioning Questionnaire containing 25 questions (NEI VFQ-25).Patients tick a score at every question to present their visual functioning (usually from 1-5 or 1-6 in which 1 is best and 6 worse). Every single item/score is transformed to a scale between 0 and 100 (0 best, 100 worse). For the total score, the mean of all transformed scores/items is calculated.~NEI VFQ 25 Quality of Life Questionnaire composite score at V5 (week 12 after surgery).~Outcome shows mean of differences and 95% confidence intervall."|12 weeks|ITT Population|||scores on a scale||Standard Deviation|Mean
1404057|NCT01228149|Secondary|Filtration Bleb Classification|"Filtration bleb classification (Grehn) in both Groups 1 week, 4 weeks, 12 weeks and 24 week after surgery.~For classification the following criteria were evaluated and scored as described below:~vascularisation (0=None, 1=mild, 2=a few corkscrew vessels)~identifiability (0=no borders to sides; 1=demarcation nasally or temporally; 2= demarcation to both sides; 3= encapsulated)~Thickness (0= a least 3mm; 1=2mm; 2= 1mm; 3=flat)~Microcysts (0=no; 1= yes)~Transparency (0= highly transparent; 2=moderate; 2=not transparent)~Mobility (0= yes; 1= no)~Leakage (0=yes, 1=no)~For the change in the filtration bleb classification (only thickness at visit 5/week 12 mentioned below) descriptive statistics were presented only."|24 weeks|PP Population|||Participants|||Count of Participants
1404058|NCT01228149|Secondary|Change in IOP Between Visit 1 and 2|Change in IOP between Visit 1 (Screening visit 16 to 28 day prior trabeculectomy) and Visit 2 (1 day before trabeculectomy). Outcome shows mean of differences and 95% confidence intervall.|28 days|PP Population|||mmHg||95% Confidence Interval|Mean
1404059|NCT01228149|Secondary|Ocular Hypotension Rate|Ocular hypotension rate (0-5 mmHg of the study eye) indicated by the number of patients with ocular hypertension|24 weeks|PP Population|||Participants|||Count of Participants
1404060|NCT01228149|Secondary|Number of Necessary 5-Fluorouracil (5FU) Injections|Number of post-operative necessary 5-Fluorouracil (5FU) injections at week 12|12 weeks|PP Population (n=58)|||number of injections||Standard Deviation|Mean
1404061|NCT01228149|Secondary|Number of Needling|number of patients requirering needling|12 weeks|Patients of the PP population|||Participants|||Count of Participants
1404062|NCT01228149|Primary|Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP|Change in IOP (ΔIOP) three months after trabeculectomy in comparison to the mean preoperative IOP at one day prior surgery|12 weeks|In total 62 patients were randomized, 30 to COSOPT-S®, 32 to DIAMOX+Dexa edo® (intention-to-treat (ITT) population. Per-protocol (PP) population (treated >8 days and did not take any medication that interfered with the study): n=58 patients: 27 p. in COSOPT-S®, 31 p. in DIAMOX+Dexa edo®. Analysis population: patients who completed the study n=53|||mmHg||95% Confidence Interval|Mean
1404063|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Intact Genotype||Day 1 of study treatment||||hours||Full Range|Median
1404064|NCT01228084|Secondary|Half-life of SFN in Blood Among Patients With Glutathione-S-Transferase Mu 1 (GSTM1) Null Genotype||Day 1 of study treatment||||Hours||Full Range|Median
1404065|NCT01228084|Secondary|Half-life of Sulforaphane (SFN) in Blood||Day 1 of study treatment||||hours||Full Range|Median
1404066|NCT01228084|Secondary|Incidence of Grade 3 or Higher Treatment Related Toxicity|Toxicities will be graded based on the NIH Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria of Adverse Events Version 4.0 (http://ctep.cancer.gov). All adverse events of any grade (for example, abnormal laboratory values, etc.) deemed clinically significant by the investigator will be recorded as a measure of the safety profile of sulforaphane|Continually through study and 14-30 days after last drug dose.||||participants|||Number
1404067|NCT01228084|Secondary|Proportion of Patients Whose PSA Levels Have Not Doubled||While on treatment with sulforaphane (less than or equal to 20 weeks.)||||percentage of participants|||Number
1404068|NCT01228084|Secondary|Minimum Percent Change in PSA (i.e., the Smallest Increase for Those With Increased PSA and the Greatest Decline for Those With Decreased PSA)||PSA measured every 28 days while on study treatment, an average of 5 months||||percent change||Full Range|Median
1404069|NCT01228084|Secondary|Percent Change in PSA From Baseline to Final Measured Value at End of Study|To determine the percentage change in PSA from baseline to the final measured value at the end of study.|Measure at baseline and after stopping study treatment (less than or equal to 20 weeks of treatment with sulforaphane.)||||Percent change||Full Range|Median
1404070|NCT01228084|Primary|Proportion of Patients Who Achieve a 50% Decline in Prostate-Specific Antigen (PSA) Levels|To determine the proportion of patients who achieve a decline in PSA levels while receiving sulforaphane treatment. as a measure of anti-tumor activity in men with recurrent prostate cancer.|Less than or equal to 20 weeks of sulforaphane treatment.||||percentage of participants|||Number
1404071|NCT01228071|Primary|Gel Drying Time|Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3”× 5” postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.|1 day; drying time measured following gel application on Day 14|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.|||minutes||95% Confidence Interval|Median
1404072|NCT01228071|Primary|Time to Steady State (SS)|Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.|14 days|The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.|||days||95% Confidence Interval|Median
1404073|NCT01228071|Primary|Time to Target Eugonadal Range|The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.|24 hours|Of the 31 subjects in the PK population, 7 subjects were not included in the analysis for time to eugonadal range. Five (5) subjects had total testosterone serum concentrations of ≥300 ng/dL at Visit 2 (baseline, time 0) and 2 subjects had total testosterone serum concentrations that never reached 300 ng/dL.|||hours||95% Confidence Interval|Median
1404074|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 24|The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of “Improved”, “Unchanged” or “Worsened” when compared to baseline.|Baseline and Week 24|Participants in safety population whose case report form contained the investigator's overall assessment after 24 weeks of treatment with TREDAPTIVE|||Percentage of Participants|||Number
1404075|NCT01228019|Primary|Investigator's Overall Efficacy Evaluation at Week 12|The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of “Improved”, “Unchanged” or “Worsened” when compared to baseline.|Baseline and Week 12|Participants in safety population whose case report form contained the investigator's overall assessment after 12 weeks of treatment with TREDAPTIVE|||Percentage of Participants|||Number
1404076|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 24|Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for triglyceride levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
1404077|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24|Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for HDL-C levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
1404078|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24|Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for LDL-C levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
1404079|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 24|Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE|Baseline and Week 24|Participants in safety population whose case report form contained baseline and Week 24 data for total cholesterol levels and had received TREDAPTIVE for 24 weeks|||mg/dL||Standard Deviation|Mean
1404080|NCT01228019|Primary|Change From Baseline in Triglycerides at Week 12|Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for triglyceride levels.|||mg/dL||Standard Deviation|Mean
1404081|NCT01228019|Primary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for HDL-C levels.|||mg/dL||Standard Deviation|Mean
1404082|NCT01228019|Primary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels.|||mg/dL||Standard Deviation|Mean
1404083|NCT01228019|Primary|Change From Baseline in Total Cholesterol at Week 12|Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE|Baseline and Week 12|Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels.|||mg/dL||Standard Deviation|Mean
1404084|NCT01228019|Primary|Percentage of Participants With Adverse Drug Reactions|An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data|||Percentage of Participants|||Number
1404085|NCT01228019|Primary|Percentage of Participants With Any Adverse Experience|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event.|From start of treatment through 14 days after the last dose (Up to 26 weeks)|Safety population: all enrolled participants who met entry criteria regarding safety data|||Percentage of participants|||Number
1404086|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Fellow Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
1404087|NCT01227993|Secondary|Change in Autofluorescence Patterns in the Study Eye as Observed on Fundus Autofluorescence (FAF) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
1404088|NCT01227993|Secondary|Change in Plaque Size in the Fellow Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
1404089|NCT01227993|Secondary|Change in Plaque Size in the Study Eye as Observed on Indocyanine Green (ICG) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
1404090|NCT01227993|Secondary|Change in Area of Leakage in the Fellow Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
1404091|NCT01227993|Secondary|Change in Area of Leakage in the Study Eye as Observed on Fluorescein Angiography (FA) Imaging at Two Years Compared to Baseline||Baseline and 2 years|||||||
1404096|NCT01227993|Secondary|Change in Serum Testosterone Levels at Two Years Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at two years. The mean change from baseline to two years is reported here in nanograms of testosterone per decaliter of serum.|Baseline and 2 years||||ng/dL||Standard Deviation|Mean
1404097|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year||||ETDRS letters|Participants|Standard Deviation|Mean
1404098|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at One Year Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 year||||ETDRS letters|Participants|Standard Deviation|Mean
1404099|NCT01227993|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years||||ETDRS letters|Participants|Standard Deviation|Mean
1404100|NCT01227993|Primary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at Two Years Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 years||||ETDRS letters|Participants|Standard Deviation|Mean
1404101|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Mean
1404102|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404103|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404104|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404105|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404106|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404107|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404108|NCT01227980|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404109|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404110|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404111|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404112|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404113|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404114|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Mean
1404115|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1404116|NCT01227980|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Mean
1404117|NCT01227967|Secondary|28-day Mortality|Number of deaths|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||participants|||Number
1404118|NCT01227967|Secondary|Percentage of Participants Who Required Hospitalization.|The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||percentage of participants analyzed||95% Confidence Interval|Number
1404119|NCT01227967|Secondary|Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen|Percentage of participants who required new or increased use of supplemental oxygen|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||percentage of participants analyzed|||Number
1404120|NCT01227967|Secondary|Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.|Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. The categories in the table are not mutually exclusive (because some participants had multiple complications) and the last row of the table summarizes all incidents.|||percentage of participants analyzed|||Number
1404121|NCT01227967|Secondary|Percentage of Participants With Clinical Failure at Day 5|Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||percentage of participants analyzed|||Number
1404122|NCT01227967|Secondary|Time to Return of Physical Function to Pre-illness Leve|Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1404123|NCT01227967|Secondary|Time to Return to Pre-influenza Function|Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1404124|NCT01227967|Secondary|Time to Feeling as Good as Before the Onset of the Influenza Illness|Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1404125|NCT01227967|Secondary|Time to Resolution of All Symptoms AND Fever|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever >=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1404126|NCT01227967|Secondary|Time to Absence of Fever|Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1404127|NCT01227967|Secondary|Time to Alleviation of Influenza Clinical Symptoms.|The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject’s first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.|From treatment initiation to Day 28|The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.|||Days||95% Confidence Interval|Median
1404128|NCT01227967|Secondary|Number of Participants Shedding Virus|Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).|At day 3 and 7.|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Participants|||Count of Participants
1404129|NCT01227967|Secondary|qPCR Viral Shedding|Median, 25% and 75% percentile of the value of viral shedding (Results <LOD were imputed as the LOD value, and Results >= LOD, <LLOQ were imputed as the LLOQ value.)|At Day 0, 3 and 7|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Log10 copies/mL||Inter-Quartile Range|Median
1404227|NCT01227785|Primary|Clinical Performance at1-month for RA Sensing Amplitude|RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients|1-month|53 CRT-D and 11 ICD patients had data available at 1-month visit.|||milli volt (mV)||Standard Deviation|Mean
1404130|NCT01227967|Secondary|Number of Participants by Virus Detection Status|Number of participants who had undetectable values (less than the limit of detection [LOD]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ|At Day 0, 3 and 7.|The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.|||Participants|||Count of Participants
1404131|NCT01227967|Primary|Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs|The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.|At Day 3|The population analyzed was restricted to the 407 participants who had a confirmed positive test for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC003. 13 participants (5 in the Combination Therapy and 8 in the Oseltamivir Monotherapy) had missing endpoint samples so were excluded from the analysis.|||percentage of participants analyzed|||Number
1404132|NCT01227954|Secondary|ApoE4 Genotype and Other Potentially Predictive Biomarkers of Cognitive Function|Per the protocol, the feasibility of the proposed translational studies were to be assessed following completion of accrual and sample collection. The decision was made not to pursue this outcome measure. No assays were performed and no data were collected for this Outcome Measure|Baseline and 4 months from start of treatment|||||||
1404133|NCT01227954|Secondary|The Frequency of Patients With Grade 3 and Higher Adverse Events (AE) Related to Treatment|For each patient the highest grade adverse event related to treatment was calculated. Those with their highest grade of 3 or higher were counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE|From start of treatment to 12 months from start of treatment|Eligible patients who started study treatment|||Participants|||Count of Participants
1404134|NCT01227954|Secondary|Progression-free Survival|Progression (radiographic) is defined as an increase in perpendicular bidimensional tumor area (at lease 50% for lesions < 1cm, at least 25% for lesions >=1cm) for any of the 1-3 tracked brain metastases, or the appearance of any new brain metastasis on a follow-up MRI. Progression-free survival was calculated instead of time to progression. Progression-free survival time was measured from registration to the date of progression, death, or last known follow-up (censored). The Kaplan-Meier method used to determine median time (along with 95% confidence intervals).|Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment|||months||95% Confidence Interval|Median
1404135|NCT01227954|Secondary|Overall Survival|Overall survival was measured from registration to the date of death or last known follow-up (censored). Kaplan-Meier estimator was used to median survival time and 95% confidence interval.|Analysis occurs after all patients have been on study for at least 4 months. (Patients are followed from registration to death or study termination whichever occurs first.)|Eligible patients who started study treatment|||months||95% Confidence Interval|Median
1404136|NCT01227954|Secondary|Quality of Life as Measured by the Barthel Index of Activities of Daily Living (ADL)|The Barthel Index of Activities of Daily Living (ADL) is a 10-item assessment. Patient scores on the ADL range from 0 to 20 with lower scores indicating declining functional status.|Baseline and 4 months from start of treatment|Eligible patients who started treatment and completed at least one ADL assessment|||units on a scale||Full Range|Median
1404137|NCT01227954|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|The FACT-Br is a 19-item self-report instrument designed to measure multidimensional quality of life in patients with brain cancer. It is to be administered with the FACT-General. The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, 0=Not a lot to 4=Very much. All subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range 0-108 for FACT-G total, 0-28 for physical, social, functional subscales, 0-24 for emotional subscale, 0-76 for brain subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale requires >= 50% of items to be completed while the overall response rate must be > 80%. If items are missing, the subscale scores can be prorated.|Baseline and 4 months from start of treatment|Eligible patients who started treatment and completed at least one FACT-Br assessment|||units on a scale||Full Range|Median
1404138|NCT01227954|Secondary|Percent Change at 4 Months in Visual Learning Measured by Cogstate's One Card Learning Test (OCLT)|The score is the arcsine of the square root of the proportion of correct responses. A higher score indicates a better performance. Each patient served as her or his own control, and the percent change in OCLT score from baseline to 4 months was calculated as 100*[(baseline score - 4 month score)/ baseline score].|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data|||percent change||95% Confidence Interval|Mean
1404139|NCT01227954|Secondary|Percent Change at 4 Months in Auditory Learning Measured by Cogstate's International Shopping List Test (ISLT)|The score is the total number of correct responses made in remembering the list on three consecutive trials in a single session. A higher score indicates a better performance. Each patient served as her or his own control, and the percent change in ISLT score from baseline to 4 months was calculated as 100*[(baseline score - 4 month score)/ baseline score].|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data|||percent change||95% Confidence Interval|Mean
1404195|NCT01227824|Secondary|Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.|Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell.|Week 48 and Week 96|ITT-E Population|||Participants|||Number
1404140|NCT01227954|Primary|Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R)|Change in Hopkins Verbal Learning Test-Revised delayed recall (HVLT_R DR) score from baseline to 4 months after the start of treatment calculated as (baseline score - 4 month score)/ baseline score. A positive change indicates a decline in function. The HVLT-R assesses verbal learning and memory. It incorporates 6 different forms, helping to mitigate practice effects of repeated administrations. Each form includes 12 nouns (targets) with 4 words drawn from 3 semantic categories, which differ across the 6 forms. Delayed recall involves recalling a list of 12 targets after a 20-minute delay. The score is the sum of the number of targets correctly recalled. Percent change calculated as 100*[(baseline score - 4 month score)/ baseline score]|Baseline and 4 months from start of treatment|Eligible patients who started treatment and had baseline and 4 month data|||percent change||95% Confidence Interval|Mean
1404141|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. The cut off for these data was October 12, 2012.|||participants|||Number
1404142|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.|||participants|||Number
1404143|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade|Grade shifts from Baseline were assessed as any grade increase (AGI), increase to Grade (G) 3 (ITG3), and increase to Grade 4 (ITG4). Toxicities were graded according to the National Cancer Institute common toxicity criteria (NCI-Common Toxicity Criteria for Adverse Events), version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades (G) 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: G1, mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; G2, moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); G3, severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; G4, Life-threatening consequences; urgent intervention indicated.; G5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Data are presented for only those participants with laboratory values. The cut off for these data was October 12, 2012.|||participants|||Number
1404144|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)|12-lead ECGs were obtained at the scheduled visits. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period. The QTc is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. In general, the faster the heart rate the shorter the QTc. If a QTc >=500 milliseconds (msec) was noted on a scheduled or unscheduled electrocardiogram (ECG), then two additional ECGs should have been obtained within 5 minutes to confirm the abnormality. The average QTc was determined from the three ECG tracings by manual evaluation and was used to determine continued eligibility.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. Only those participants for which a post-Baseline ECG was conducted were analyzed. The cut off for these data was October 12, 2012.|||participants|||Number
1404145|NCT01227928|Secondary|Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline|Systolic blood pressure (SBP) and Diatolic blood pressure (DBP) are measured in millimeters of mercury (mmHg). A participant could have been counted in more than one shift category. Participants who experienced shifts in both SBP and DBP are represented under each individual parameter. A worst-case on-therapy shift is defined as the worst shift that occurred at any time during the treatment period.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population. One participant on placebo did not report any blood pressure measurements post-Baseline. The cut off for these data was January 10, 2014.|||participants|||Number
1404146|NCT01227928|Secondary|Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE|An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
1404147|NCT01227928|Secondary|Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
1404148|NCT01227928|Secondary|Number of Participants With the Indicated On-therapy Grade 3-5 AEs|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. The NCI-CTCAE Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE. ALT=alanine aminotransferase; AST=aspartate aminotransferase.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
1404149|NCT01227928|Secondary|Number of Participants With Any Grade 3 or 4 AE|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0 was used to grade AEs per the following scale to assess severity: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling AE; Grade 5, death related to AE.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
1404150|NCT01227928|Secondary|Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. On-therapy AEs were those reported from the first day that randomized study drug was received to 28 days after the last dose of randomized study drug, and within 28 days of dose interruption. Relatedness was assessed by the Investigator.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
1404151|NCT01227928|Secondary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalizaton or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. See the non-serious AE/SAE module for a list of specific events.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment. The cut off for these data was January 10, 2014.|||participants|||Number
1404152|NCT01227928|Secondary|Number of Participants With Any Dose Reduction or Any Dose Interruption|Dose interruptions or reductions may have been required following potential drug-related toxicities. As a general rule, if dose reduction of investigational product (IP) was necessary, the dose should have been reduced stepwise by 200 mg at each step, and the participant should have been monitored for 10 to 14 days. If toxicity recurred or worsened during this monitoring time, the IP could have been interrupted and/or the dose of IP further decreased, with continued monitoring for an additional 10 to 14 days, and so on. The cut off for these data was October 12, 2012.|From Week 1 until the end of the treatment period (up to Study Week 108)|All Treated Population: all randomized participants who received at least one dose of investigational product. Treatment assignments in the All Treated Population were based on the actual treatment received, if different from the randomized treatment.|||participants|||Number
1404211|NCT01227785|Primary|Clinical Performance at Implant for RV Pacing Impedance|RV pacing impedance results were reported at implant|implant|79 CRT-D and 46 ICD patients had data available at implant|||Ohms||Standard Deviation|Mean
1404153|NCT01227928|Secondary|PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria|"PFS by GCIG criteria is defined as the time from the randomization date to the earliest date of disease progression (PD) per GCIG criteria or death due to any cause. Per GCIG criteria, an objective progression is defined as the earliest event of either tumor progression based on RECIST v1.0 or confirmed CA-125 progression. A participant is counted as Progressed per RECIST if the radiological PD per RECIST occurred prior to or on the same day as CA-125 progression. A participant is counted as Progressed per CA-125 if the radiological PD occurred after CA-125 progression. Per RECIST, PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment."|From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)|ITT Population. The cut off for these data was October 12, 2012.|||months||95% Confidence Interval|Median
1404154|NCT01227928|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of randomization to the date of death due to any cause.|From randomization until death due to any cause (average of 29.4 months)|ITT Population. Participants who were alive as of study completion were censored at the last contact date. The cut off for these data was January 10, 2014.|||months||95% Confidence Interval|Median
1404155|NCT01227928|Primary|Progression-free Survival (PFS)|PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants’ dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.|From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)|Intent-to-Treat (ITT) Population: all randomized participants who were not screen failures. Participants who were screen failures and randomized by mistake, but who did not receive study treatment, were not included. The treatment assignment in the ITT Population was based on the randomized treatment. The data cut off was October 12, 2012.|||months||95% Confidence Interval|Median
1404156|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Want to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1404157|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Want to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you want to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1404158|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Current Ability to do the Things You Need to do|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1404159|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Current Ability to do the Things You Need to do Component of the PGI-C Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current ability to do the things you need to do: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1404160|NCT01227902|Secondary|Change From Baseline in the PGI-C Score: Epilepsy-related Worry|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse? Rating scores are integers from 1 to 7, with 1=Much better and 7=Much worse.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1404161|NCT01227902|Secondary|Number of Participants With the Indicated Response for the Epilepsy-related Worry Component of the Patient Global Impression of Change (PGI-C) Score|The PGI-C questionnaire was to be completed by the participant. Participants were asked the following question: Compared to before you started this study, how would you rate your current epilepsy-related worry: Much better, Moderately better, A little better, Unchanged, A little worse, Moderately worse, Much worse?|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1404169|NCT01227902|Secondary|Percent Change From Baseline in Partial-onset Seizure Frequency|Percent change from Baseline was calculated as the difference in the partial-onset seizure frequency (Treatment Phase minus the Baseline Phase) divided by the Baseline Phase frequency, multiplied by 100. Negative values indicate reductions from Baseline. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population|||percent change||Standard Deviation|Mean
1404162|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Mental Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The mental component summary (MCS) score is a summary score representing overall mental health, which is derived from the 8 domains. As with the domains, MCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1404163|NCT01227902|Secondary|Change From Baseline in the SF-36v2 Physical Component Summary Score at Week 20/Early Withdrawal|The SF-36 v2 Health Survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health).The physical component summary (PCS) score is a summary score representing overall physical health, which is derived from the 8 domains. As with the domains, PCS scores range from 0 to 100; higher scores represent better health. Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1404164|NCT01227902|Secondary|Change From Baseline in the Short Form 36 Health Survey, Version 2 (SF-36v2) Domain Scores at Week 20/Early Withdrawal|The SF-36v2 health survey is a self-administered, generic, 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. Positive changes from Baseline indicate improvement.|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1404165|NCT01227902|Secondary|Percent Change From Baseline in Functional Status: Percentage of Days With no Missed Work or School Time|"Participants were asked the following question daily: Did you miss any time from work or school in the last 24 hours due to epilepsy? Possible responses were Yes, No, and NA=Not Applicable (no planned work or school in the last 24 hours). The variable summarized is the percentage of days with no missed work or school. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A positive percent change from Baseline indicates a reduction from Baseline in missed work or school."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1404166|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Wanted to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you wanted to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I wanted to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1404167|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Limitation of Ability to do What You Needed to|"Participants were asked the following question daily: How would you rate the extent to which epilepsy limited your ability to do what you needed to do over the last 24 hours? The original possible responses were 0-10, with 0=Not at all limited and 10=Unable to do anything I needed to. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1404168|NCT01227902|Secondary|Functional Status Diary (FSD): Percent Change From Baseline in Epilepsy-related Worry|"Participants were asked the following question daily: How would you rate your epilepsy-related worry over the last 24 hours? The original possible responses were 0-10, with 0=No worry and 10=Worst worry imaginable. However, in the summarization, 1 was added to each participant's daily response, changing the possible values to 1-11, so that there would be no possibility of the percent change from Baseline being undefined. Baseline and Treatment Phase averages were calculated for each participant. The denominators for these by-phase averages were the number of non-missing days for each variable and phase. The by-phase averages were used as follows in the calculation of percent change from Baseline for each participant: 100 x Treatment Phase average – Baseline Phase average) / Baseline Phase average. A negative percent change from Baseline indicates a reduction from Baseline."|Baseline through Week 20/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1404170|NCT01227902|Secondary|Number of Participants With a >=25%, >=75%, or 100% Reduction in Partial-onset Seizure Frequency From Baseline|The number of participants experiencing a >=25%, >=75%, and 100% reduction from Baseline in partial-onset seizure frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population|||participants|||Number
1404171|NCT01227902|Secondary|Number of Participants With the Indicated Reduction or Increase From Baseline in Partial-onset Seizure Frequency|Participants were assessed for the percent change from Baseline in seizure frequency; changes were categorized as Any Decrease (>0 to 25%, 25 to <50%, 50 to 75%, >75 to 100%) or No Change or Any Increase (>25%, 0 to 25%). A partial-onset seizure is a seizure that has its onset in a limited area on one side of the brain. Partial-onset seizures may remain limited or may spread to involve both sides of the brain.|From Baseline through Week 20 (Day 140)/Early Withdrawal|ITT Population|||participants|||Number
1404172|NCT01227902|Primary|Number of Participants With a >=50% Reduction in Partial-onset Seizure (POS) Frequency From Baseline|The number of participants experiencing a >=50% reduction from Baseline (BL) in POS frequency during the Treatment Phase (TP) (i.e., Titration Phase and Flexible Dose Evaluation [FDE] Phase) was measured. A POS has its onset in a limited area on one side of the brain. POSs may remain limited or may spread to involve both sides of the brain. For both the Baseline Phase and the TP, seizure frequency was calculated as a 28-day rate using the following formula: 28 x {[(number of countable partial seizures in Phase) + (10 x number of days with innumerable seizures in Phase) + (number of occurrences of status epilepticus in Phase)] / number of applicable days in the Phase}, where all days in the Phase are considered applicable (including days with 0 seizures), except for days on which the participant failed to complete the Seizure Diary. >= 50% reduction from BL is calculated as 100 x (28-day partial seizure rate [PSR] for the TP - 28-day PSR for the BL Phase) / 28-day PSR for the BL Phase.|From Baseline through Week 20 (Day 140)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants in the Safety Population (all participants who took at least one dose of investigational product) who provided at least one post-Baseline efficacy assessment|||participants|||Number
1404173|NCT01227889|Secondary|Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay|Analytical and clinical validation of the companion diagnostic (cDx) assay was performed to determine the extent of agreement between the bioMerieux cDx assay (THxID BRAF Assay) and the Clinical Trial Assay (CTA) to detect BRAF mutations to determine participant eligibility into the study. Skin tissue samples collected at the Screening visit were used for this analysis. Multiple specimen per participant were analyzed.|Screening|V600E positive participants screened for BREAK-3 study|||Percent agreement||95% Confidence Interval|Number
1404174|NCT01227889|Secondary|Number of Participants With Non-melanoma Skin Lesions: Randomized Phase|Dermatological examinations were performed by the investigator, or at the discretion of the investigator, referred to a dermatologist. The number of participants with non-melanoma skin lessions was assessed from the time of Screening until study completion or discontinuation from the study for any reason.|From Screening until study completion or discontinuation from the study (up to 9.9 months)|Safety Population: all randomized participants who received at least one dose of study drug, based on the actual treatment received, if this differed from that to which the participant was randomized|||participants|||Number
1404175|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Crossover Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 6.4 months)|Crossover Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||Months||95% Confidence Interval|Median
1404176|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Crossover Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (up to 6.4 months)|Crossover Treatment Population. At the time data were analyzed for overall response, only 37 participants had crossed over from DTIC treatment to GSK25118436 treatment.|||participants|||Number
1404191|NCT01227824|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||log10 c/mL||Standard Deviation|Mean
1404192|NCT01227824|Secondary|Change From Baseline in Plasma HIV-1 RNA Over Time|Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||log10 c/mL||Standard Deviation|Mean
1404177|NCT01227889|Secondary|Progression-free Survival (PFS2) as Assessed by the Investigator: Crossover Phase|PFS2 is defined as the time from the first dose of GSK2118436, in participants randomized to DTIC who crossed over to GSK2118436 after initial progression, to the earliest date of radiographic or photographic disease progression or death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time from first dose of GSK2118436 in participants who crossover after initial progression to the earliest date of radiographical or photographical PD or death due to any cause (up to 6.4 months)|Crossover Treatment Population: the subset of participants who were randomized to the DTIC arm, and who elected at the point of disease progression to receive GSK2118436. Only participants who received at least one dose of GSK2118436 were included in the Crossover Treatment Population.|||Months||95% Confidence Interval|Median
1404178|NCT01227889|Secondary|Duration of Response as Assessed by an Independent Radiologist: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. NA indicates that data is not available.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 7.4 months)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||Months||95% Confidence Interval|Median
1404179|NCT01227889|Secondary|Duration of Response as Assessed by the Investigator: Randomized Phase|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) was defined as the time from the first documented evidence of a PR or CR until the first documented sign of PD or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|Time from the first documented evidence of PR or CR until the first documented sign of disease progression or death due to any cause (up to 65.6 weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||Months||95% Confidence Interval|Median
1404180|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed CR or PR as Assessed by an Independent Radiologist: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an independent radiologist per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 12.0 weeks)|ITT Population|||participants|||Number
1404181|NCT01227889|Secondary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator: Randomized Phase|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Response was evaluated by an investigator per RECIST, version 1.1. A participant without a post-Baseline assessment of response was considered a non-responder. Confirmation, per RECIST version 1.1, requires a confimatory disease assessment of CR or PR at least 28 days after the initial disease assessment of CR or PR.|From randomization until the first documented evidence of a confirmed complete response or partial response (median of 6.6 weeks)|ITT Population|||participants|||Number
1404182|NCT01227889|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)|ITT Population|||Months||95% Confidence Interval|Median
1404183|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|ITT Population|||Months||95% Confidence Interval|Median
1404184|NCT01227889|Primary|Progression-free Survival (PFS) as Assessed by the Investigator|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 millimeters (mm). For participants who did not progress or die, PFS was censored at the date of last contact. Data are presented as median and 96% confidence interval.|Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered|||Months||95% Confidence Interval|Median
1404185|NCT01227824|Secondary|Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG|The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa.|Week 4, Week 24, and Week 48|PK Concentration Population.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1404186|NCT01227824|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.|Week 4, Week 24, and Week 48|PK Concentration Population|||Micrograms*hour per milliliter(µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1404187|NCT01227824|Secondary|Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)|All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. Safety Population: all participants who received at least one dose of investigational product|From Baseline until Week 96|Safety Population.|||Participants|||Number
1404188|NCT01227824|Secondary|Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death.|From Baseline until Week 96|ITT-E Population|||Participants|||Number
1404189|NCT01227824|Secondary|Absolute Values in CD4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||cells/mm^3||Standard Deviation|Mean
1404190|NCT01227824|Secondary|Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time|CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles).|Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96|ITT-E Population.|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
1404193|NCT01227824|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96.|Week 48 and Week 96|ITT-E Population|||Participants|||Number
1404196|NCT01227824|Primary|Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48|Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication.|Baseline up to Week 48|ITT-E Population.|||Percentage of participants|||Number
1404197|NCT01227785|Primary|Wanded Telemetry Issues at Pre-discharge Follow-up|The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.|Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit|118 was the total number of questionnaires completed and available from the PI for analysis.|||issues|||Number
1404198|NCT01227785|Primary|Spontaneous Episode Conversion Success Rate at 3 Months|Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.|3-month|Of the 13 CRT-D and 8 ICD patients that experienced a spontaneous episode, the successful conversions were reported.|||percentage of successful conversions|Participants||Number
1404199|NCT01227785|Primary|Induced Episode Detection Times at 3 Months|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|3-month|Of the 6 CRT-D and 3 ICD patients with available data that had succesful conversion after induced VT/VF episodes, the mean time was determined at 3 months|||seconds||Standard Deviation|Mean
1404200|NCT01227785|Primary|Induced Episode Detection Times at 1-month|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|1-month|Of the 1 CRT-D and 1 ICD patients that underwent induced VT/VF at 1month, the mean time for successful conversion was reported.|||seconds||Standard Deviation|Mean
1404201|NCT01227785|Primary|Induced Episode Detection Times at Implant|The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.|implant|Of the 30 CRT-D and 22 ICD patients with induced VT/VF episodes, the mean time required for conversion was reported for all available data|||seconds||Standard Deviation|Mean
1404202|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 3-months|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|3-month|Of the 6 CRTD and 3 ICD patients that had induced VT/VF episodes at 3-month follow-up, the number of those that were converted successfully was reported in %|||percentage of successful conversions|||Number
1404203|NCT01227785|Primary|Induced VT/VF Episode Successful Conversion Rates at 1-month|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|1-month|Of all patients that experienced an induced VT/VF episode at 1-month, the number that had successful conversions was reported for both CRT-D and ICD patients.|||percentage of successful conversions|||Number
1404204|NCT01227785|Primary|Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant|The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.|implant|Of the 30 CRT-D and 22 ICD patients with induced episodes, the number with successful conversions was determined. The % of patients that had successful conversion was then reported.|||percentage of successful conversions|||Number
1404205|NCT01227785|Primary|Product Experiences Reported by the Site for All Patients for Study Duration|Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.|Overall study results|All patients from overall study population were considered. Of the total population, the number of product experiences was reported.|||experiences|||Number
1404206|NCT01227785|Primary|Clinical Performance at 1-month for RA Pacing Impedance|RA pacing impedance results were reported at 1-month post-implant|1-month|54 CRT-D and 11 ICD patients had data available at 1-month|||Ohms||Standard Deviation|Mean
1404207|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Pacing Impedance|RA pacing impedance results were reported at pre-discharge|pre-discharge|57 CRT-D and 11 ICD patients had data available at pre-discharge|||Ohms||Standard Deviation|Mean
1404208|NCT01227785|Primary|Clinical Performance at Implant for RA Pacing Impedance|RA pacing impedance results were reported at implant|implant|56 CRT-D and 11 ICD patients had data available at implant|||Ohms||Standard Deviation|Mean
1404209|NCT01227785|Primary|Clinical Performance at 1-month for RV Pacing Impedance|RV pacing impedance results were reported at 1-month post-implant|1-month|75 CRT-D and 43 ICD patients had data available at 1-month visit|||Ohms||Standard Deviation|Mean
1404210|NCT01227785|Primary|Clinical Performance at Pre-discharge for RV Pacing Impedance|RV pacing impedance results were reported for pre-discharge|pre-discharge|78 CRT-D and 45 ICD patients had data available at pre-discharge|||Ohms||Standard Deviation|Mean
1404228|NCT01227785|Primary|Clinical Performance at Pre-discharge for RA Sensing Amplitude|RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients|pre-discharge|55 CRT-D and 11 ICD patients had data available at pre-discharge visit.|||milli volt (mV)||Standard Deviation|Mean
1404229|NCT01227785|Primary|Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude|RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients|implant|55 CRT-D patients and 11 ICD patients had available data at implant.|||milli volt (mV)||Standard Deviation|Mean
1404230|NCT01227785|Primary|Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients|LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.|1-month|68 patients in the CRT-D cohort had available data at 1month visit|||milli volt (mV)||Standard Deviation|Mean
1404231|NCT01227785|Primary|Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.|pre-discharge|69 patients in the CRT-D arm had available data at pre-discharge visit.|||milli volt (mV)||Standard Deviation|Mean
1404232|NCT01227785|Secondary|Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.|A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2).|Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months|HF events were reported and adjudicated to classify patients into group 1 or 2. Group 1=17 HFEs in 13 patients. For patients with multiple HFEs,only the first with sufficient data was used. 8/13 with a HFE had data for the endpoint analysis.Group 2=95 patients with 9 month follow-up. 90/95 had data eligible for inclusion in the endpoint analysis.|||breaths/min||Inter-Quartile Range|Median
1404233|NCT01227785|Primary|Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients|Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.|implant|The number of CRT-D patients with available data at implant|||milli volt (mV)||Standard Deviation|Mean
1404234|NCT01227707|Secondary|TTP - Time to Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer. TTP was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||months||Standard Deviation|Mean
1404235|NCT01227707|Secondary|Time to Disease Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from date of treatment start until first documented progression of disease or death due to underlying cancer.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||percentage of participants|||Number
1404236|NCT01227707|Secondary|OS - Time to Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive. OS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||months||Standard Deviation|Mean
1404237|NCT01227707|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of first day of treatment until death due to any cause or the last date the participant was known to be alive.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months|ITT population|||percentage of participants|||Number
1404238|NCT01227707|Secondary|DFS - Time to Event|The time in months from date of start-of-treatment to the date of event defined as the first documented disease progression or death due to any cause. If a participant did not have an event, the time was censored at the date of last adequate tumor assessment. DFS was estimated using the Kaplan-Meier method.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population|||months||Standard Deviation|Mean
1404239|NCT01227707|Secondary|Disease-Free Survival (DFS) - Percentage of Participants With an Event|DFS was defined as the time from treatment start date to the date of first progression of disease or date of death due to any cause.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population|||percentage of participants|||Number
1404240|NCT01227707|Secondary|Percentage of Participants With Relapse During Follow-Up|The percentage of participants with local and/or regional relapse during follow-up. New lesions located at rectum or at colon or at lymph node detected at the end of NAT were evaluated as local and/or regional relapse.|BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months|ITT population; only participants who underwent radical surgery were included in the analysis|||percentage of participants|||Number
1404241|NCT01227707|Secondary|Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment|The percentage of participants with new lesions located at the primary tumor site were evaluated at the end of NAT.|BL and within 6 weeks after the completion of study treatment|ITT population|||percentage of participants|||Number
1404262|NCT01227629|Secondary|Trough Plasma Concentration of Dabigatran (BIBR 953)|The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.|12 weeks|All treated patients|||ng/ml||Standard Deviation|Mean
1404242|NCT01227707|Secondary|Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment|Percentage of participants with an overall response of CR was evaluated as the proportion of participants with CR for the target and non-target lesions plus absence of new lesions at the end of NAT according to RECIST. CR was defined as disappearance of all target lesions, all non-target lesions, and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population|||percentage of participants|||Number
1404243|NCT01227707|Secondary|Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment|Percentage of participants with CR was evaluated as the proportion of participants with complete response for the target and non-target lesions, separately, at the end of NAT according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions or all non-target lesions and normalization of tumor marker levels.|BL and within 6 weeks after the completion of study treatment|ITT population|||percentage of participants|||Number
1404244|NCT01227707|Secondary|Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure||6 to 8 weeks after completion of study treatment|ITT population; only participants who underwent surgery were included in the analysis. n (number) equals (=) number of participants assessed for the specified parameter (colostomy)|||percentage of participants|||Number
1404245|NCT01227707|Secondary|Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)|The frequencies of clinical tumor stage T (0, 1, 2, 3, 4, or X), regional lymph nodes stage N (0, 1, 2, 3, or 4), and distant metastasis clinical stage M (0, 1, or X) at baseline and at the end of NAT were assessed. The frequencies of pathological tumor stage T and regional lymph nodes stage N at surgery were evaluated. The clinical tumor and lymph node status was assessed by clinical examination, endosonography, and/or rectosigmoidoscopy, and pelvic and abdomen computerized tomography (CT) scan or magnetic resonance imaging (MRI). Response to treatment had to be assessed within 6 weeks after end of treatment by using the same techniques performed at baseline.|Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment)|ITT population|||percentage of participants|||Number
1404246|NCT01227707|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.|6 to 8 weeks following completion of neoadjuvant treatment|ITT population; only participants who underwent surgery and had pathological tumor stage data were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1404247|NCT01227681|Primary|Motor Performance of Unified Parkinson's Disease Rating Scale|To assess Unified Parkinson's Disease Rating Scale part III (motor function) scores from baseline Medication-off status to Medication-off status after G-CSF injection one year. Scores of UPDRS Part III ranges from 0 to 108 and higher values indicate worse outcome.|2 years||||scores on a scale||Full Range|Mean
1404248|NCT01227668|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs During Phase 2|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Weekly from Weeks 1 through 16 (end of treatment) of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2|||Participants|||Number
1404249|NCT01227668|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation During Phase 1|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Weekly from Week 1 to Week 26 and continuously to end of treatment|All participants who took at least 1 dose of single-blind aripiprazole in Phase 1|||Participants|||Number
1404250|NCT01227668|Secondary|Change From Baseline in Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 16 (Last Observation Carried Forward [LOCF])|CG-I rating scale permits global evaluation of patient’s improvement over time. At baseline (BL), CGI Severity of Illness assessment is performed, in which the clinician rates severity of patient’s condition on a 7-point scale ranging from 1=no symptoms to 7=very severe symptoms. Higher total score=worse symptoms. At subsequent visits, clinician assesses patient’s improvement relative to symptoms at baseline on CGI-I 7-point scale ranging from 1=very much improved to 7=very much worse. Since the drug targets irritability symptoms, the CGI focuses on severity of irritability secondary to autistic disorder. Lower score=more improved symptoms. LOCF data set includes data recorded at a given visit or, if nothing recorded, data areccarried forward from the prior visit. For secondary endpoints (endpt), hierarchical testing was used to keep overall experiment-wise type I error rate to <=0.05. diff=difference; IS=irritability scale; PA=primary analysis; signif=significance/significantly.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.|||Units on a scale||Standard Error|Mean
1404263|NCT01227629|Secondary|Activated Partial Thromboplastin Time (aPTT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability|||seconds||Standard Deviation|Mean
1404264|NCT01227629|Secondary|Ecarin Clotting Time (ECT): Difference From Baseline||baseline and 12 weeks|All treated patients. No statistical comparisons due to high variability|||seconds||Standard Deviation|Mean
1404251|NCT01227668|Secondary|Adjusted Mean Change From Baseline to Week 16 on the Aberrant Behavior Checklist Irritability (ABC-I) Subscale Score (Last Observation Carried Forward [LOCF])|ABC is an informant-based checklist used to assess and classify problem behaviors of children and adolescents with mental retardation. The 58 items are rated on a 4-point scale (0=not at all a problem to 3=the problem is severe in degree), and resolve into 5 subscales: 1) irritability, agitation; 2) lethargy, social withdrawal; 3) stereotypic behavior; 4) hyperactivity, noncompliance; and 5) inappropriate speech. The ABC can be completed by parents, special educators, psychologists, direct caregivers, nurses, and others knowing the participant. Psychometric assessment of the ABC indicates that its subscales have high internal consistency, adequate reliability, and established validity. The ABC-I Subscale Score ranges from 0 to 45, with a negative change in score signifying improvement. LOCF data set includes data recorded at a given visit or, if no observation was recorded at that visit, data carried forward from the prior visit. chg=change; BL=baseline; APR=aripiprazole; vs=versus.|From Baseline (end of Phase 1) to Week 16 of Phase 2|All participants who were randomized and took at least 1 dose of double-blind medication in Phase 2 and who had at least 1 efficacy evaluation after the start of Phase 2 study drug.|||Units on a scale||Standard Error|Mean
1404252|NCT01227668|Primary|Percentage of Patients Relapsing by Week 16|"Time of relapse=date when patient meets relapse criteria. There are 4 definitions for relapse: 1. Patient meets the following criteria for 2 consecutive visits: (a) Aberrant Behavior Checklist Irritability score ≥25% than score at end of Phase 1 AND (b) Clinical Global Impression Improvement scale rating of ‘Much Worse’ or ‘Very Much Worse’ relative to rating at end of Phase 1. If relapse criteria met at 1 visit, 2nd visit should occur in about 1 week to reevaluate whether relapse criteria are still met. 2. Patient discontinues for Lost to Follow-up after a visit in which he or she met Definition 1 criteria (a&b). 3. Patient begins a prohibited drug (whether a study investigator or outside source prescribed) to treat worsening symptoms of irritability of autistic disorder after a visit where patient met Definition 1 criteria (a&b). 4. Patient discontinues due to hospitalization for worsening symptoms of irritability or due to lack of efficacy based on investigator’s assessment."|From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment|All participants who were randomized in Phase 2|||Percentage of participants|||Number
1404253|NCT01227655|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3~Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4~The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.~The NMSS total score is calculated by adding all domain scores (0–360), and lower scores mean less disability."|14-15 weeks||||units on a scale||Standard Deviation|Mean
1404254|NCT01227655|Secondary|Parkinson’s Disease Sleep Scale (PDSS)|"The Parkinson’s disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.~Subscale has 0-10 ratings, where 0 = severe and 10 = normal~The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14-15 weeks||||units on a scale||Standard Deviation|Mean
1404255|NCT01227655|Secondary|UPDRS (Unified Parkinson’s Disease Rating Scale) Sections I (ON), II (ON and OFF), and III (ON)|"Total UPDRS SCORE (I, II (ON), and III) Change from Baseline to Endpoint~UPDRS I evaluation of mentation, behavior, and mood~UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food~UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.~Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe~The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14-15 weeks||||units on a scale||Standard Deviation|Mean
1404256|NCT01227655|Primary|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) Compared With Placebo, When Administered With the Existing Treatment of L-DOPA Plus a DDCI (DOPA Decarboxylase Inhibitor)|Efficacy of 2 BIA 9-1067 (25 mg, and 50 mg) compared with placebo, when administered with the existing treatment of L-DOPA plus a DDCI (DOPA decarboxylase inhibitor), in patients with PD and end-of-dose motor fluctuations. The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period.|14-15 weeks||||minutes||Standard Deviation|Mean
1404257|NCT01227629|Secondary|Severity of Adverse Events|Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.|12 weeks|Treated patients(Numbers of patients for adverse events are counted for each treatment and are in their sum greater than the total number of patients randomized as 14 patients on Dabigatran with ASA changed treatment,12 patients down titrated Dabigatran bid to qd of which one did the down titration at the same time as the stop of the ASA treatment)|||participants|||Number
1404258|NCT01227629|Secondary|Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline|Number of Participants with Increase of ALT to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
1404259|NCT01227629|Secondary|Number of Participants With Increase of Bilirubin to >2*Baseline|Increase of Bilirubin to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
1404260|NCT01227629|Secondary|Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline|Increase of AP to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
1404261|NCT01227629|Secondary|Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline|Increase of AST to more than two times the baseline value|12 weeks|All treated patients. No statistical comparisons due to extremely small number of cases|||Participants|||Number
1404268|NCT01227629|Secondary|Thromboembolic Events: Number of Participants Who Died|Occurence of death by all causes|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404269|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Other Major Cardiac Events|Occurence of other major adverse cardiac events|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404270|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Myocardial Infarction|Occurence of a myocardial infarction|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404271|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Systemic Thromboembolism|Occurence of a systemic thromboembolism|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404272|NCT01227629|Secondary|Thromboembolic Events: Number of Participants With Transient Ischemic Attack|Occurence of a transient ischemic attack|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404273|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Ischemic Stroke|Occurence of an ischemic stroke (fatal or non-fatal)|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404274|NCT01227629|Secondary|Number of Participants With Thromboembolic Events: Composite Endpoint|Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality|12 weeks|All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404275|NCT01227629|Primary|Number of Participants With Minor/Nuisance Bleeding Events|All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group|||Participants|||Number
1404276|NCT01227629|Primary|Number of Participants With Minor/Relevant Bleeding Events|Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding|12 weeks|All treated patients. No statistical comparisons were performed, due to the small number of events per group|||Participants|||Number
1404277|NCT01227629|Primary|Number of Participants With Fatal or Life-threatening Major Bleeding Events|Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more|12 weeks|All treated patients. No statistical comparisons were performed, due to the extremely small number of events.|||Participants|||Number
1404278|NCT01227577|Secondary|Event-free Survival, Progression-free Survival and Overall Survival|Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
1404279|NCT01227577|Secondary|Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Of the 128 participants analyzed, 3 participants received an escalated dose of 400 mg b.i.d.|||Participants|||Number
1404280|NCT01227577|Secondary|Number of Participants With Loss of CCyR, MMR and CMR|Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.|4 years|Numbers are based on the total number of participants who achieved and experienced loss of CMR (34 participants), CCyr (93 participants) and MMR (94 participants), respectively.|||Participants|||Number
1404281|NCT01227577|Secondary|Time to Progression of AP/BC|Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.|4 years|Of the 128 participants analyzed, 1 participant experienced progression to AP/BC.|||Months||95% Confidence Interval|Median
1404282|NCT01227577|Secondary|Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)|Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
1404283|NCT01227577|Secondary|Duration of CMR, CCyR and MMR|Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).|||Months||Standard Deviation|Mean
1404284|NCT01227577|Secondary|Time to CMR, CCyR and MMR|Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.|4 years|Of the 128 participants analyzed, 34 participants achieved CMR within 18 months of treatment, 93 participants achieved CCyR and did not experience loss of CCyR during the study, and 94 participants achieved MMR with up to 24 months of treatment (most achieved MMR within 12 months of treatment).|||Months||95% Confidence Interval|Median
1404285|NCT01227577|Secondary|Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)|"CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).~Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses."|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
1404286|NCT01227577|Primary|Number of Participants With Confirmed Complete Molecular Response (CMR)|CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.|4 years|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
1404287|NCT01227564|Other Pre-specified|Alzheimer’s Disease Medication Administration Concerns Questionnaire (AD MACQ)|The AD MACQ was administered to the study partner to address preferences for medication administration by assessing: Question a: I would find it easy to give the study medication to the patient myself. Question b: The number of times the medication was given was convenient. Question c: I would prefer to have the study medication given at home by me instead of at the doctor's office by the doctor or nurse. Question d: I would prefer to have the study medication given at home by a nurse instead of at the doctor's office by the doctor or nurse. Question e: Overall, I am satisfied with the way the medication was given.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||percentage of participants|||Number
1404288|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Total Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 – 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404289|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Planning/Organization Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 – 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404290|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Prospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 – 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404291|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Retrospective Memory Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 – 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404292|NCT01227564|Other Pre-specified|Change From Baseline in PDQ-R – Relative – Attention/Concentration Domain Score|The PDQ-R is a tool consisting of 20 questions, is designed to assess perceived cognitive deficits, and was administered to the study partner. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13, and 17, with a range from 0 – 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404293|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Total Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Total Score is computed by adding raw scores for all of the items (or all 4 domain scores) together. It could range from 0 – 80, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404322|NCT01227551|Secondary|Durable Response Rate|Per Immune-Related Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI or calipers: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Durable Response Rate (DRR) = CR + PR.|6 months or more|ITT Population|||percentage of participants|||Number
1404294|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Planning/Organization Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Planning/Organization Domain Score is the sum of the raw scores on items 4, 8, 12, 16, and 20, with a range from 0 – 4 for each of the 5 items. So the Planning/Organization Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404295|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Prospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Prospective Memory Domain Score is the sum of the raw scores on items 3, 7, 11, 15, and 19, with a range from 0 – 4 for each of the 5 items. So the Prospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404296|NCT01227564|Other Pre-specified|Change From Baseline in PDQ – Subject – Retrospective Memory Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Retrospective Memory Domain Score is the sum of the raw scores on items 2, 6, 10, 14, and 18, with a range from 0 – 4 for each of the 5 items. So the Retrospective Memory Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404297|NCT01227564|Other Pre-specified|Change From Baseline in Perceived Deficits Questionnaire (PDQ) – Subject – Attention/Concentration Domain Score|The PDQ is a tool consisting of 20 questions and is designed to assess perceived cognitive deficits from the participant’s perspective. The instrument assessed a variety of questions in the following areas: attention/concentration, retrospective memory, prospective memory, and planning/organization. The Attention/Concentration Domain Score is the sum of the raw scores on items 1, 5, 9, 13 and 17, with a range from 0 – 4 for each of the 5 items. So the Attention/Concentration Domain Score could range from 0 – 20, with higher scores indicating greater perceived cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404298|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgM ELISA Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The LLOQ determined for this assay was 50 U/mL. For any anti-Aβ IgM antibody level that was below the LLOQ (50 U/mL), the LLOD defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||U/ml||95% Confidence Interval|Geometric Mean
1404299|NCT01227564|Other Pre-specified|Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers|Site personnel collecting the samples for anti-Aβ antibody titers were blinded to the participant treatment group assignment. The lower limit of quantification (LLOQ) determined for this assay was 100 U/mL. For any anti-Aβ IgG antibody level that was below the LLOQ (100 U/mL), the lower limit of detection (LLOD) defined as 0.5*LLOQ was imputed.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||U/ml||95% Confidence Interval|Geometric Mean
1404300|NCT01227564|Other Pre-specified|Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time|CDR is a global clinical staging instrument that was administrated by a trained rater to assess a participant’s level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. CDR global score was derived from the six domains according to a complex algorithm with emphasis on the Memory Domain score. Global CDR score = 0.5 with memory box score of 0.5. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3, with higher score indicating no significant function. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||percentage of participants|||Number
1404301|NCT01227564|Other Pre-specified|Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer’s related-dementia was performed informally by the participant’s friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the other caregivers providing support on ADL, IADL and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL and supervising; and: time per day during the past month on each of ADL, IADL, and supervising. The total Other Caregiver Time per month could range from 0 – 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||hours||95% Confidence Interval|Least Squares Mean
1404321|NCT01227564|Primary|Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)|Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.|104 weeks|The full analysis set (FAS) population included all randomized participants who had at least one dose of investigational product.|||ratio||95% Confidence Interval|Least Squares Mean
1404302|NCT01227564|Other Pre-specified|Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver|An abbreviated administration of the RUD (RUD-Lite) was used. The RUD-Lite is a comprehensive tool for addressing the magnitude and nature of study partner/caregiver effort in cases of dementia. Since a significant portion of care in Alzheimer’s related-dementia was performed informally by the participant’s friends or family, it was desirable to measure the extent of this care for use in economic evaluations of disease. The total time spent by the primary caregiver providing support on activities of daily living (ADL), instrumental activities of daily living (IADL) and supervising, respectively, was calculated in two components. Total number of days spent during the past month on each of ADL, IADL, and supervising; and: time per day during the past month on each of ADL, IADL and supervising. The total Primary Caregiver Time per month could range from 0 – 720. This was calculated by multiplying the number of days per month (30) by the number of hours per day (24).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||hours||95% Confidence Interval|Least Squares Mean
1404303|NCT01227564|Other Pre-specified|Change From Baseline in Dependence Scale (DS) Score|An abbreviated administration (first 6 items) of the DS was used in this study. The DS is a brief study partner-completed measure which assesses the degree of support required by a subject with AD. Since the goal of treatment was to delay or arrest the processes leading to increased dependence, the DS represented a meaningful endpoint for clinical studies in AD. The dependence score was derived by summing the first 6 items of the DS. Item 1 and 2 ranged from 0 – 2 and item 3 – 6 ranged from 0 – 1. The total score was calculated by summing the score from each of the 6 items. So the total score could range from 0 – 8, with higher scores indicating greater dependence.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||Standard Deviation|Mean
1404304|NCT01227564|Other Pre-specified|Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score|The ADAS-Cog is a global cognitive measure. For the following 13 items, the participants were rated: Word Recall, Commands, Construction Praxis, Delayed Word Recall Task, Naming Task, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Instructions, Spoken Language Ability, Word-Finding Difficulty in Spontaneous Speech, Comprehension, and Number Cancellation. The ADAS-cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The total score was the sum of the scores from the 13 individual items. This study used a modified 85 point scale with a scoring range of 0 to 85 (13 items). Higher scores of the 13 individual items indicated greater cognitive impairment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
1404305|NCT01227564|Other Pre-specified|Change From Baseline in Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief, structured examination of cognitive function consisting of the 11 item: Orientation-What, Orientation-Where, Registration-Objects, Attention and Calculation, Recall, Language-Naming, Language-Repetition, Language-Comprehension, Language-Reading, Language-Writing, and Language- Drawing. MMSE total score was the sum of the 11 item scores and it ranges from 0 to 30 with higher score indicating greater cognitive functioning. If any individual item is missing, then the MMSE total score is set to missing. A positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
1404306|NCT01227564|Other Pre-specified|Change From Baseline in NPI Distress Score (NPI-D)|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. For each domain, the study partner also rated his/her own ‘emotional or psychological’ distress caused by the participant’s behavior on a 6-point scale. The study partner NPI-D total score was calculated by summing the scores of the 12 sub-scale distress scores. A negative change indicated an improvement from baseline. The caregiver distress (NPI-D) total score is calculated by summing the scores of the 12 sub-scale distress scores. The NPI-D total scores ranges from 0 to 60 with higher scores indicating greater distress.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
1404307|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|The NPI scale assesses 12 domains (delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, nighttime behavior, and appetite and eating changes). The symptoms were rated on the basis of questions administered to the study partner. If a preliminary question for each domain was answered as ‘Yes’, each domain was rated on a 4-point frequency scale and on a 3-point severity scale. If the preliminary question was answered as ‘No’, the frequency, severity, and distress scales were set to zero. A negative change indicated an improvement from baseline. For each of the 12 domains, a sub-scale score is calculated as frequency*severity and ranges from 0 to 12. The NPI total score is then calculated by summing the scores of the 12 sub-scale scores. The NPI total scores ranges from 0 to 144 with higher scores indicating greater behavioral impairment. The caregiver distress score is not included in the NPI total score.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
1404308|NCT01227564|Other Pre-specified|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)|Clinical Dementia Rating (CDR) is a global clinical staging instrument that was administrated by a trained rater to assess a participant’s level of impairment in six domains including: Memory, Orientation, Judgement and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care, based on the CDR interview. The CDR included discussions with the participant and study partner using a structured format. A CDR-SOB score was derived based on individual scores from the six domains. A negative change indicated an improvement from baseline. The total CDR-SB score is calculated as the sum of the six clinical ratings. The CDR-SOB score range for each domain is 0 to 3. The CDR-SOB total score ranges from 0 to 18, with higher scores indicating greater dementia. If any individual item is missing, then the CDR-SB is set to missing.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
1404309|NCT01227564|Other Pre-specified|Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant’s ability to perform a variety of activities ranging from shopping, doing the laundry, simple financial transactions, comprehension of current events, some recreational or avocational activities, and reading. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||score||95% Confidence Interval|Least Squares Mean
1404310|NCT01227564|Other Pre-specified|Change From Baseline in Neuropsychological Test Battery (NTB)|The NTB evaluated cognitive domains that are known to be affected early in the course of Alzheimer's disease (AD). The cognitive tests included in the NTB were: Rey Auditory Verbal Learning Test – Immediate recall, Detection, Identification, Go-No-Go Task, One Back Task, Controlled Oral Word Association Test, Category Fluency Test, and Rey Auditory Verbal Learning Test – delayed recall and recognition. For each of the eight NTB components, an individual z-score was derived based on the primary raw score of each test. Based on the individual z-scores, a composite z-score was derived using the formula: (z1-z2-z3-z4+z5+z6+z7+z8)/8. Positive change indicating an improvement from baseline.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||z-scores||95% Confidence Interval|Least Squares Mean
1404311|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right|Right HBSI measures the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
1404312|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left|Left HBSI measures the left hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
1404313|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total|Left HBSI and Right HBSI respectively measure the left hippocampal atrophy and the right hippocampal atrophy from registered MRI scan pairs, by subtracting the corresponding area under the intensity profile across a boundary in the repeat scans. HBSI (Total) is defined as the summation of the left HBSI and the right HBSI.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
1404314|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)|VBSI measures ventricular volume change from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
1404315|NCT01227564|Other Pre-specified|Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)|BBSI measures whole brain atrophy from registered MRI scan pairs, by subtracting the area under the intensity profile across a boundary in the repeat scans from the initial scan (baseline).|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||mL||95% Confidence Interval|Least Squares Mean
1404316|NCT01227564|Other Pre-specified|Change From Baseline in Plasma Aβ x-40|Site personnel collecting the samples for plasma Aβ (x-40) concentrations and the results were blinded to the participant treatment group assignment.|104 weeks|FAS population included all randomized participants who had at least one dose of investigational product.|||pg/mL||95% Confidence Interval|Least Squares Mean
1404317|NCT01227564|Other Pre-specified|Change From Baseline in CSF Total Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
1404318|NCT01227564|Other Pre-specified|Change From Baseline in CSF p-Tau|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
1404319|NCT01227564|Other Pre-specified|Change From Baseline in CSF Aβ x-42|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at ET visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
1404320|NCT01227564|Other Pre-specified|Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40|For the majority of the participants, the lumbar puncture for the first CSF sample was collected up to 3 days prior to injection of investigational product. For the participants who had a CSF being already drawn at week 80, no CSF sample was drawn at week 104, nor at the Early termination (ET) visit. For those participants who early terminated the study before week 80, CSF was drawn at ET visit.|Week 80 or Week 104|FAS population included all randomized participants who had at least one dose of investigational product.|||μg/ml||95% Confidence Interval|Least Squares Mean
1405009|NCT01220466|Other Pre-specified|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|Percent of eyes that lost more than 2 lines of BSCVA.|||percentage of eyes|Participants|95% Confidence Interval|Number
1404323|NCT01227551|Primary|Percentage of Participants With Immune-related Progression-Free Survival (irPFS) at 6 Months|To assess the clinical efficacy of Intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months.|6 months|ITT Population|||percentage of participants||95% Confidence Interval|Number
1404324|NCT01227512|Secondary|Percentage of Participants Requiring Rescue Therapy for Hyponatremia|Percentage of participants requiring rescue therapy within first 7 days of treatment for hyponatremia.|7 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 3 participants in the placebo group.|||Percentage of participants|||Number
1404325|NCT01227512|Secondary|Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Score Improved to a Score of 1 or 2.|Percentage of responders (defined as CGI-I score of 1 = very much improved or 2 = much improved) at 48 hours post-first dose, or at discharge/rescue therapy, if earlier. Participants given rescue therapy were given a score of 7.|48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 2 participants in the tolvaptan group and 3 participants in the placebo group.|||Percentage of participants|||Number
1404326|NCT01227512|Secondary|Time to First 2-point Improvement in CGI-S Score.|CGI-S data up to 72 hours were used to identify 2-point improvements. Please refer to outcome measure 2 for details on the scale. For the analysis of time to first 2-point improvement in CGI-S, CGI-S data up to Hour 72 were used to identify 2-point improvements. Data for participants who received rescue therapy were censored at the time of receiving rescue therapy. For participants who were discharged before Hour 72 without reaching 2-point improvement in CGI-S, data were censored at the time of discharge. Other participants who did not reach the 2-point improvement during the 72 hours also had their data censored at their last CGI-S observations within 72 hours.|Up to 72 hours|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were missing for 1 participant in the tolvaptan group and 3 participants in the placebo group.|||Hours||95% Confidence Interval|Median
1404327|NCT01227512|Secondary|Change From Baseline in Serum Sodium Concentration (24 Hour Area Under the Curve [AUC]).|"Average 24 hour AUC of serum sodium concentration change from baseline, from Day 1 Hour 0 up to 72 hours post-first dose was assessed.~A serum sodium sample was drawn at pre-treament and 8, 24, 48, and 72 hours post-first dose. Serum sodium was also assessed between 36 and 72 hours after the last dose.~Analysis of AUC was for daily average AUC, hence the units or AUC are mEq/L/24 hours."|0 to 72 hours|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for 3 participants in the tolvaptan group and 1 participant in the placebo group."|||mEq/L||Full Range|Least Squares Mean
1404328|NCT01227512|Secondary|Change From Baseline to 48 Hours Post Dose in Clinical Global Impression - Improvement (CGI-I) Score of Hyponatremia Symptoms.|"Change in CGI-I score at 48 hours post-first dose or discharge/rescue therapy, if earlier was assessed.~The CGI-I is a one-question rating scale where the participant is asked to rate total improvement whether or not, in their judgment, it is due entirely to trial treatment. Compared to his/her condition at admission to the trial, how much has he/she changed? 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse"|Baseline to 48 hours post dose|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation. Data were not available for 2 participants in the tolvaptan group.|||Units on a scale||Full Range|Median
1404329|NCT01227512|Secondary|Change From Baseline to 24 and 72 Hours Post Dose in CGI-S of Hyponatremia Symptoms.|"Change in CGI-S of hyponatremia symptoms from pretreatment baseline at 24 and 72 hours post-first dose, or at discharge/rescue therapy if earlier was assessed.~The CGI-S is a one-question rating scale which was as follows: “Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?” 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 24 and 72 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group."|||Units on a scale||Full Range|Median
1404330|NCT01227512|Secondary|Change From Baseline to 48 Hour Post Dose in Clinical Global Impression-Severity (CGI-S) of Hyponatremia Symptoms.|"Change from baseline in blinded rater assessed CGI-S at 48 hours post-first dose or at discharge/rescue therapy, if earlier was assessed.~The CGI-S is a one-question rating scale which was as follows: “Considering your total clinical experience with hyponatremia symptoms in this particular population, how symptomatic is the patient at this time?” 0=not assessed; 1=normal, not at all symtpmatic; 2=borderline symptomatic; 3=mildly symptomatic; 4=moderately symptomatic; 5=markedly symptomatic; 6=severely symptomatic; 7=among the most severly symptomatic patients."|Baseline to 48 hours post dose|"Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.~Data were missing for one participant in the Tolvaptan group."|||Units on a scale||Full Range|Median
1404331|NCT01227512|Primary|Length of Hospital Stay (LoS)|LoS was time to clinically ready to be hospital discharged (CRBD) from study treatment initiation, disregarding prolonged hospitalization due solely to social factors.|45 days|Analysis was performed on the modified intent-to-treat population (MITT) which included all randomized participants who received at least one dose of study drug regardless of any protocol violation.|||Days||95% Confidence Interval|Median
1404332|NCT01227434|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants with protocol related toxicity described by CTCAE version 4.0|1-2 years||||participants|||Number
1404587|NCT01225549|Secondary|Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge|Minimum Percentage of FEV1 over 0 to 3 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set|||Percentage||Full Range|Geometric Mean
1404333|NCT01227434|Primary|Progression Free Survival|Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.|up to 142 weeks||||weeks||Full Range|Mean
1404334|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B|||Participants|||Number
1404335|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2|Proportion of patients seroprotected and seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A H3N2|||Participants|||Number
1404336|NCT01227421|Secondary|Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1|Proportion of patients seroprotected or seroconverted at day 28|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1|||Participants|||Number
1404337|NCT01227421|Secondary|Influenza Antibody Response: Influenza B|Change in antibody titer for Influenza B|28 days|Members of intensive virologic follow up group with laboratory confirmed Influenza B|||Fold change in antibody titer||Inter-Quartile Range|Median
1404338|NCT01227421|Secondary|Influenza Antibody Response: Influenza A H3N2|Change in antibody titer for Influenza A H3N2|28 days|Members of the intensive virologic follow up group with laboratory confirmed influenza A H3N2|||Fold change in antibody titer||Inter-Quartile Range|Median
1404339|NCT01227421|Secondary|Influenza Antibody Response Titer Change: Influenza A 2009 H1N1|change in influenza antibody titer for Influenza A 2009 H1N1|28 days|Member of the intensive virologic follow up group with laboratory confirmed Influenza A 2009 H1N1|||Fold change in antibody titer||Inter-Quartile Range|Median
1404340|NCT01227421|Secondary|Complications of Influenza|Proportion of patients with a complication of influenza during the course of the study|28 days|All patients who received at least one dose of study medication|||Participants|||Number
1404341|NCT01227421|Secondary|Time Loss From Work|Time loss from work|28 days|Analysis conducted on 241 patients with laboratory confirmed influenza excluding those who are unemployed|||days||95% Confidence Interval|Mean
1404342|NCT01227421|Secondary|Symptom Severity Score Hours|Sum of the symptom severity score hours from first dose to resolution of symptoms. Patients rated each symptom's severity on a score from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Total symptom severity score hours were calculated by multiplying the sum of the severity scores by duration of symptoms.|28 days|Analysis conducted for 257 patients with laboratory confirmed influenza|||symptom score *hour||Standard Deviation|Mean
1404343|NCT01227421|Secondary|Time to Return to Normal Daily Activities|Time in hours as reported by patient|28 days|Analysis conducted on 257 patients with laboratory confirmed influenza|||Hours||Inter-Quartile Range|Median
1404344|NCT01227421|Secondary|Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50)|Median time in hours|28 days|Analysis performed on 107 patients from the intensive virologic follow up population with laboratory confirmed influenza|||Hours||Inter-Quartile Range|Median
1404345|NCT01227421|Secondary|Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline|Change in viral titer logarithm with base 10 (log10) Ribonucleic Acid (RNA)copies|7 days|Analysis conducted on 113 patients from the intensive virologic follow up group with laboratory confirmed influenza|||LOG10 RNA copies||Standard Deviation|Mean
1404346|NCT01227421|Secondary|Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline|Change in viral titer presented as logarithm with base 10 (log10) 50% Tissue Culture Infective Dose (TCID50)|7 days|Analysis conducted on 113 patients from intensive virologic follow up group with laboratory confirmed influenza|||LOG10 Titer||Standard Deviation|Mean
1404347|NCT01227421|Secondary|Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects|Time in hours (Median and Interquartile range)|at least 28 days|624 patients were enrolled based on inclusion/exclusion criteria. Secondary efficacy analyses were conducted on the 257 patients with laboratory confirmed influenza.|||Hours||Inter-Quartile Range|Median
1404348|NCT01227421|Primary|Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects|The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection|Up to 28 days|624 patients were enrolled based on inclusion/exclusion criteria. The primary efficacy analysis was conducted on the 257 patients with laboratory confirmed influenza.|||Hours||Inter-Quartile Range|Median
1404349|NCT01227395|Secondary|Number of Participants Prevented by Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1404350|NCT01227395|Secondary|Number of Participants That Responded to Azithromycin Treatment.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results.|9 years(MAX)|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1404351|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404352|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404353|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404354|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Treatment).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404355|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Allergies (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without allergies is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404356|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Renal Dysfunction (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether with or without renal dysfunction is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404357|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Concomitant Drugs (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether with or without concomitant drugs is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drugs was confirmed.|||participants|||Number
1404358|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin Tablets to determine whether male or female is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404359|NCT01227395|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events -Age (Prophylaxis).|Number of participants with Treatment Related Adverse Events(TRAEs) of Azithromycin to determine whether <65 years or >=65 years is significant risk factor.|9 years(MAX)|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404360|NCT01227395|Primary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Azithromycin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|9 years(MAX)|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.|||Events|||Number
1404361|NCT01227395|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Azithromycin, irrespective of causal relationship to Azithromycin (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Azithromycin.|9 years(MAX)|No statistical analysis provided for the frequency of treatment related adverse events.|||participants|||Number
1404362|NCT01227382|Secondary|Adverse Events|Adverse events were prospectively evaluated at the end of the procedure, at discharge from the endoscopy unit, and by telephone call 24 hours post procedure. Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria.|24 hours|Percentage of participants with accurate diagnoses of cancer|||participants|||Number
1404363|NCT01227382|Secondary|Sampling Times for Each Device|The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).|15 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
1404364|NCT01227382|Secondary|Cholangioscopy Visualization Time|The portion of the total ERCP time spent on Cholangioscopy visualization.|30 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
1404365|NCT01227382|Secondary|Total Cholangioscopy Time|This is the total time it takes for the dye to be performed during the ERCP.|60 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
1404366|NCT01227382|Secondary|Total Procedure Time|The total time to perform ERCP|120 minutes|Percentage of participants with accurate diagnoses of cancer|||minutes||Standard Deviation|Mean
1404367|NCT01227382|Secondary|Procedure Technical Success|The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.|day 1|Percentage of participants with accurate diagnoses of cancer|||participants|||Number
1404396|NCT01227005|Primary|Units of Blood Products Required During the First 24 Hours After Emergency Department Admission|Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)|first 24 hours after ED admission||||units of blood||Inter-Quartile Range|Median
1404368|NCT01227382|Primary|Percentage of Participants With Accurate Diagnoses of Cancer|The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.|up to 7 days after the procedure|Percentage of participants with accurate diagnoses of cancer|||percentage of accurate diagnoses|||Number
1404369|NCT01227278|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe ). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Deviation|Mean
1404370|NCT01227278|Secondary|Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment). Participants with 0.5 point improvement from baseline in the domain scores were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of participants|||Number
1404371|NCT01227278|Secondary|Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393|The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rated their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items were equally weighted, and domain scores were calculated as the mean of all items within each domain; domain score range: 1 (maximum impairment) to 7 (no impairment).|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Deviation|Mean
1404372|NCT01227278|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total Score|SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score were derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. Percentage of participants with 4-point, 8-point and 12-point change from baseline in SGRQ-C total score were observed.|Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of participants|||Number
1404373|NCT01227278|Secondary|Change From Baseline in COPD-Specific Saint George’s Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question’s response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline, Day 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Deviation|Mean
1404374|NCT01227278|Secondary|Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of hospitalization due to AECOPD was calculated as Rate = total number of hospitalizations/ total person years.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||hospitalizations/person-year||95% Confidence Interval|Number
1404375|NCT01227278|Secondary|Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||percentage of participants|||Number
1404671|NCT01224639|Primary|Number of Participants With Solicited Local and Systemic AEs||Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
1404376|NCT01227278|Secondary|Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.|Day 1 up to 393|The PP population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||participants|||Number
1404377|NCT01227278|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 561 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to 561|The safety population included all participants who received at least one dose of investigational drug.|||participants|||Number
1404378|NCT01227278|Primary|Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Annualized Incidence Rate of Moderate or Severe AECOPD was assessed based on AECOPD data up to Day 393 (Rate = total number of moderate or severe AECOPD in each group/total person-year follow-up in each group). The severity of an exacerbation of COPD is defined as: a) Mild exacerbations, which require treatment with an increase in usual therapy, example (eg), increase use of short acting bronchodilators, b) Moderate exacerbations which require treatment with systemic corticosteroids, and or antibiotics and c) Severe exacerbations which require hospitalization.|Day 1 up to 393|The per protocol (PP) population included all participants who had no major protocol violations, received at least 6 of the 8 total doses of investigational product, and completed the study through Day 393.|||AECOPD events/person-year||95% Confidence Interval|Number
1404379|NCT01227265|Primary|Change From Baseline in Total Epworth Sleepiness Scale (ESS) at Week 12|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness. The mean change from baseline in total EES was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Score on a Scale||Standard Error|Mean
1404380|NCT01227265|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Percentage of participants|||Number
1404381|NCT01227265|Primary|Number of Participants With Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg Increase|The number of participants with Diastolic Blood Pressure (DBP) ≥105 mmHg and 15 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Participants|||Number
1404382|NCT01227265|Primary|Number of Participants With Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg Increase|The number of participants with Systolic Blood Pressure (SBP) ≥180 mmHg and 20 mmHg increase was reported. Participants lie supine at rest for 5 minutes, then have a single BP measurement taken (ie, 1 reading). Participants then stand for 3 minutes at rest, followed by a single BP measurement (1 reading) in the standing position.|Up to Week 14|All Participants as Treated (APaT): All participants who received at least one (1) dose of study drug.|||Participants|||Number
1404383|NCT01227265|Secondary|"Change From Baseline in Average On Time (Hours Per Day) Without Troublesome Dyskinesia at Week 12"|"On time is when a PD participant's symptoms are improved. Mean on time without troublesome dyskinesias is derived from the available diary data collected for 3 days immediately prior to a clinic visit. On time without troublesome dyskinesia is the sum of on time without dyskinesia plus on time with non-troublesome dyskinesia as recorded in the diary. The mean change from baseline in on time was based on a cLDA with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.|||hours per day||Standard Error|Mean
1404397|NCT01226745|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 35 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 35 days after the last dose of study drug administration, assessed up to 5 years|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
1404384|NCT01227265|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"A participant with at least a 30% reduction in mean off time from Baseline to End of Treatment (Week 12) is considered as responder. The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week 12 visit."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least one dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.|||Percentage of participants|||Number
1404385|NCT01227265|Primary|"Change From Baseline in Average Off Time (Hours Per Day) at Week 12"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week 12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis (cLDA) with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|Full Analysis Set (FAS): All randomized participants remaining after participants were excluded for failure to receive at least one dose of study treatment, lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment, or lack of Baseline data for those analyses requiring Baseline data.|||hours per day||Standard Error|Mean
1404386|NCT01227057|Secondary|Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months|The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment.|6 months||||units on a scale||Standard Deviation|Mean
1404387|NCT01227057|Secondary|The Activities of Daily Living in Hoarding (ADL-H)|The Activities of Daily Living in Hoarding (ADL-H) was used to assess functional impairment. Higher scores represent increased impairment. Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.|6 months||||units on a scale||Standard Deviation|Mean
1404388|NCT01227057|Primary|Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months|Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms. Subtests include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. The range of the total score is 0-92, with higher scores indicating worse hoarding severity.|6 months||||units on a scale||Standard Deviation|Mean
1404389|NCT01227018|Other Pre-specified|Biomarker Evaluation|Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.|Pre-treatment and 1 week post-treatment|The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed.||||||
1404390|NCT01227018|Secondary|Number of Patients With Each Worst Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity related to study treatment. One patient withdrew before treatment. One patient did not have a toxicity related to study drug or therapy.|||participants|||Number
1404391|NCT01227018|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|study entry to date of death or last date known alive (assessed over 2.5 yrs)|All patients are included in the analysis on intention‐totreat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1404392|NCT01227018|Secondary|Best Response|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date, to date of disease progression (assessed up to 1 year)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non‐evaluable for best overall response.|||participants|||Number
1404393|NCT01227018|Primary|Disease Control Rate|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.|at 8 weeks from the start of therapy|Patients who received treatment and who were available for determination of response.|||percentage of participants|||Number
1404394|NCT01227005|Secondary|30-day Mortality|Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy|first 30 days after ED admission||||participants|||Number
1404395|NCT01227005|Secondary|24-hour Mortality|Mortality rate at 24 hours after arrival|First 24 hours after ED admission||||participants|||Number
1404398|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormalities in Dermatological Examination|A whole body examination, paying particular attention to identify precancerous or cancerous lesions was done by a dermatologist and based on the clinical judgment of the dermatologist the abnormalities were categorized as clinically significant or clinically not significant. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline up to end of the treatment, assessed up to Week 255|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
1404399|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Ophthalmologic Examination|Subjects underwent comprehensive ophthalmic examination (COE) including best corrected visual acuity (Snellen), manifest refractions, pupil examination, ocular motility, nystagmus, confrontation visual fields, Ishihara color plates, Amsler grid, and tonometry as well as a biomicroscopy slit lamp examination of the conjunctiva, cornea, anterior chamber, iris and lens; and a fundoscopic examination (with dilation) of the vitreous, optic nerve, retinal vessels, macula, and peripheral retina. Optical Coherence Tomography (OCT): Thicknesses of the macular retina and retinal nerve fiber layer at the optic nerve head in each eye was assessed by OCT using the fast macular thickness map scan and the fast retinal nerve fiber layer (RNFL) scan features, respectively. The abnormalities of the ophthalmologic examination was judged to be clinically significant or not as per the investigators discretion. The ophthalmologic examination was performed for both right eye (RE) and left eye (LE).|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.|||Subjects|||Number
1404400|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Electrocardiogram (ECG) Measures|The 12-lead ECG was recorded after the subject was in supine position for 5 minutes. ECGs were acquired on digital cardiographs. Abnormal findings were analyzed as clinically significant or not clinically significant as per the discretion of the study investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
1404401|NCT01226745|Primary|Change From Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO)|DLCO was one of the most clinically valuable tests of lung function. The DLCO measure the ability of the lungs to transfer gas from inhaled air to the red blood cells in pulmonary capillaries. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject was early terminated from the study during the additional 2 year period with delay. The values for the DLCO “% of predicted” was defined as the mean value of 2 test results that were within a 10% variability of each other.|Baseline, Week 40, 52, early termination, Week 152, 200, 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.|||Percentage of predicted value||Standard Deviation|Mean
1404402|NCT01226745|Primary|Change From Baseline in Forced Vital Capacity (FVC)|FVC (% of predicted value) was the volume of air which was forcibly exhaled from the lungs after taking the deepest breath possible. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure|||Percentage of predicted value||Standard Deviation|Mean
1404403|NCT01226745|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Percent (%) Predicted Value)|FEV1 was defined as the maximal volume of air exhaled in the 1st second of a forced expiration from a position of full inspiration. FEV1 was obtained from spirometry, performed before study treatment administration. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay shall be defined.|Baseline, Week 40, 52, 76, 100, 124, 148, early termination, Week 152, 200, early termination 2, Week 255|Safety analysis set consisted of all the enrolled subjects. Here “n” signifies the number of subjects analyzed for the individual time point in the outcome measure.|||Percentage of predicted value||Standard Deviation|Mean
1404404|NCT01226745|Secondary|Percent Brain Volume Change (PBVC) From Baseline at the End of Treatment|Brain volume was obtained by magnetic resonance imaging (MRI). Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. Brain volume changes very little over time. Hence, the PBVC at the end of treatment was calculated by adding up all the PBVC values from the scans performed during the extension treatment period.|Baseline and at end of treatment (Week 255)|FAS included all subjects who provided any post baseline efficacy data. One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.|||Percent brain volume||Standard Deviation|Mean
1404405|NCT01226745|Secondary|Change From Baseline in Lesion Volume at the End of the Treatment (EoT)|Brain lesion volume was obtained by magnetic resonance imaging (MRI). Extension study baseline was defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EOT) was defined as the last visit during the treatment period. Change from extension baseline to EOT = last treatment period value in extension study — extension baseline value.|Baseline, End of treatment (5 years)|FAS included all subjects who provided any post baseline efficacy data.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period.|||Cubic centimeter (cc)||Standard Deviation|Mean
1404423|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.~Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 6 weeks||||summary score||Standard Deviation|Mean
1404406|NCT01226745|Secondary|Number of Gadolinium (Gd)-Enhanced Lesions|Gd-enhanced lesions were obtained by magnetic resonance imaging (MRI) at each scheduled assessment visit over the study period. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study. End of treatment (EoT) lesion count is the average number of lesion counts per scan, calculated by dividing the sum of all lesion counts by number of scans during the extension treatment period. Early termination visit was recorded when the subject was early terminated from the study during the first 2.5 year period, while early termination 2 visit was recorded when the subject early terminated from the study during the additional 2 year period with delay. Extension study baseline is defined as the measurement most immediately prior to or on the day of the first dose day of extension study.Full Analysis Set (FAS) included all subjects who provided any post baseline efficacy data.|Baseline, Week 40, 52, 100, 148, early termination, Week 152, 200, early termination 2, Week 255 and end of treatment (5 years)|"FAS. n” signifies the number of subjects analyzed for individual time point in the outcome measure.One randomized error subject was summarized in the sequence 0.15-0.15 as he received 0.15 in core study period and in the sequence Placebo-0.10 mg as he received 0.10 in the extension study period."|||Lesions||Standard Deviation|Mean
1404407|NCT01226745|Primary|Number of Subjects With Clinically Significant Abnormal Vital Signs|Vital signs included oral temperature, pulse, respiration rate and blood pressure (BP) (taken after 5 minutes in the sitting position). The abnormalities in vital signs were decided as clinically significant or not based on the clinical judgment of the investigator.|Baseline up to Week 255|Safety analysis set consisted of all the enrolled subjects.|||Subjects|||Number
1404408|NCT01226732|Secondary|Preliminary Efficacy Assessment: Response Rate (RR)|Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Includes all patients evaluable for response (4 patients were not evaluable)|||participants|||Number
1404409|NCT01226732|Secondary|Safety|To evaluate the drug related toxicities associated with different doses of the drugs used in this regimen.|18 months||||participants|||Number
1404410|NCT01226732|Primary|Dose Determination|To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors.|18 months||||mg/m^2|||Number
1404411|NCT01226719|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|All patients on study|||months||95% Confidence Interval|Median
1404412|NCT01226719|Secondary|To Determine the Acute Toxicity Produced by This Regimen.|The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.|18 months|All patients on study|||participants|||Number
1404413|NCT01226719|Secondary|Progression-free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|All patients on study|||months||95% Confidence Interval|Median
1404414|NCT01226719|Secondary|R0 Resection Rate|To determine the rate of complete (R0) resection for patients treated with this regimen.|18 months|Includes patients who were surgical candidates and underwent surgery on study|||percentage of patients with surgery|||Number
1404415|NCT01226719|Primary|Overall Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients deemed to be evaluable for response who were evaluated for response|||percentage of evaluable participants|||Number
1404416|NCT01226706|Secondary|Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months|Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up|Baseline to 6 months||||Participants|||Count of Participants
1404417|NCT01226706|Secondary|Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up|Frequency of participants needing self-catheterization from baseline to 6 month follow-up.|Baseline to 6 months||||Participants|||Number
1404418|NCT01226706|Secondary|Frequency of Urinary Tract Infections From Baseline to 6 Months|Frequency of urinary tract infections from baseline to 6 month-follow-up|Baseline to 6 months||||number of occurences|||Number
1404419|NCT01226706|Secondary|24 Hour Pad Weight (gm) at 9 Months|weight of pad (in gm) worn for 24 hours to detect urine loss|9 months||||gm||Standard Deviation|Mean
1404420|NCT01226706|Secondary|24 Hour Pad Weight (gm) at 3 Months|weight of pad (in gm) worn for 24 hours to detect urine loss|3 months||||gm||Standard Deviation|Mean
1404421|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 6 Months|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.~Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 6 months||||summary score||Standard Deviation|Mean
1404422|NCT01226706|Secondary|Change in Indevus Urgency Severity Scale From Baseline to 3 Months|"A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.~Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges."|Baseline to 3 months||||summary score||Standard Deviation|Mean
1404472|NCT01226420|Secondary|Safety of Alefacept Infusions in Patients With Chronic GVHD.|Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.|2 years|All enrolled subjects were included in the Analysis of Safety Events|||Total adverse events|||Number
1404424|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 6 Months|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.~Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems."|Baseline to 6 months||||summary score||Standard Deviation|Mean
1404425|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 3 Months|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.~Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems."|Baseline to 3 months||||summary score||Standard Deviation|Mean
1404426|NCT01226706|Secondary|Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks|"Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.~Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 some very minor problems. 3 some minor problems, 4(some) moderate problems, 5 severe problems, and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems."|Baseline to 6 weeks||||summary score||Standard Deviation|Mean
1404427|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.~The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 months||||summary score||Standard Deviation|Mean
1404428|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.~The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 3 months||||summary score||Standard Deviation|Mean
1404429|NCT01226706|Secondary|Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up|"Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Urogenital Distress Inventory – 6 (UDI-6) The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 weeks||||summary score||Standard Deviation|Mean
1404430|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 months||||summary score||Standard Deviation|Mean
1404431|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 3 months||||summary score||Standard Deviation|Mean
1404432|NCT01226706|Secondary|Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up|"Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.~Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100."|Baseline to 6 weeks||||scores on a scale||Standard Deviation|Mean
1404473|NCT01226420|Primary|Efficacy|Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.|2 years|All enrolled subjects|||participants|||Number
1404433|NCT01226706|Secondary|Subjective Benefit Assessment at 6 Months|"Self assessed description of how well they believed the Botulinum Toxin type A was working.The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:~dry (complete response),~improvement (> 50% reduction in incontinence),~partial response (≤ 50% reduction in incontinence),~no response to treatment."|Baseline to 6 months||||score on a 4-point rating scale||Standard Deviation|Mean
1404434|NCT01226706|Secondary|Subjective Benefit Assessment at 3 Months|"Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:~dry (complete response),~improvement (> 50% reduction in incontinence),~partial response (≤ 50% reduction in incontinence),~no response to treatment."|Baseline to 3 months||||score on a 4-point rating scale||Standard Deviation|Mean
1404435|NCT01226706|Secondary|Subjective Benefit Assessment at 6 Weeks|"Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:~dry (complete response),~improvement (> 50% reduction in incontinence),~partial response (≤ 50% reduction in incontinence),~no response to treatment."|Baseline to 6 weeks||||score on a 4-point rating scale||Standard Deviation|Mean
1404436|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 24 Months Follow-up|Frequency of night voiding|Baseline and 24 months||||number of voids||Standard Deviation|Mean
1404437|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 12 Month Follow-up|Frequency of night voiding|Baseline to 12 months||||number of voids||Standard Deviation|Mean
1404438|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 9 Month Follow-up|Frequency of night voiding|Baseline and 9 months||||Number of voids||Standard Deviation|Mean
1404439|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 6 Month Follow-up|Frequency of night voiding|Baseline to 6 months||||number of voids||Standard Deviation|Mean
1404440|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 3 Month Follow-up|Frequency of night voiding|Baseline to 3 months||||Number of voids||Standard Deviation|Mean
1404441|NCT01226706|Secondary|Change in Number of Night Voids Between Baseline and 6 Week Follow-up|Frequency of night voiding|Baseline to 6 weeks||||number of voids||Standard Deviation|Mean
1404442|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up|Frequency of daily urination|Baseline to 24 months||||number of voids||Standard Deviation|Mean
1404443|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up|Frequency of daily urination|Baseline to 12 months||||number of voids||Standard Deviation|Mean
1404444|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up|Frequency of daily urination|Baseline to 9 months||||number of voids||Standard Deviation|Mean
1404445|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up|Frequency of daily urination|Baseline to 6 months||||number of voids||Standard Deviation|Mean
1404446|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up|Frequency of daily urination|Baseline to 3 month||||number of voids||Standard Deviation|Mean
1404447|NCT01226706|Secondary|Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up|Frequency of daily urination|Baseline to 6 weeks||||number of voids||Standard Deviation|Mean
1404448|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 24 Months Follow-up|Incontinence- involuntary leakage of urine|Baseline and 24 months||||number of occurences||Standard Deviation|Mean
1404449|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 12 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline and 12 months||||number of occurences||Standard Deviation|Mean
1404450|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 9 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 9 months||||number of occurences||Standard Deviation|Mean
1404451|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 6 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 6 month||||number of episodes||Standard Deviation|Mean
1404452|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 3 Month Follow-up|Incontinence- involuntary leakage of urine|Baseline to 3 month||||number of occurences||Standard Deviation|Mean
1404453|NCT01226706|Secondary|Change in Incontinence Episodes Between Baseline and 6 Week Follow-up|Incontinence- involuntary leakage of urine|Baseline to 6 weeks||||number of episodes||Standard Deviation|Mean
1404454|NCT01226706|Primary|Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up|"Cystoscopy is a test performed with a cystoscope, a narrow tube with a tiny camera at its tip, inserted into the urethra and bladder to see the inside of the bladder and urethra.~Maximum bladder capacity--the amount of liquid or gas the bladder can hold under anesthesia. Without anesthesia, capacity is limited by either pain or a severe urge to urinate."|Baseline to 6 months||||mL||Standard Deviation|Mean
1404455|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal behavior score at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal behavior score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
1404474|NCT01226121|Secondary|Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)||90 days||||percentage of patients|||Number
1404475|NCT01226121|Primary|Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)||30 days after injection||||percentage of participants|||Number
1404456|NCT01226511|Secondary|Percentage of Participants During the 18-Week Extension Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|10 weeks up to 28 weeks|Randomized participants with a C-SSRS suicidal ideation score <5 at the last 2 visits in the acute treatment period and at least 1 C-SSRS suicidal ideation score during the extension treatment period. Nine (9) participants from 1 site with major quality issues were excluded.|||percentage of participants|||Number
1404457|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for pooled investigator, baseline, and age category within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGAS score during the acute treatment period and at least 1 CGAS score during the extension treatment period [last observation carried forward (LOCF)], excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404458|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of mental illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a CGI-S score during the acute treatment period and at least 1 CGI-S score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404459|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity total score during the acute treatment period and at least 1 PARS severity total score during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404460|NCT01226511|Secondary|Change From 10-Week to 28-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for pooled investigator, visit, baseline, age category, baseline*visit, and age category*visit within reporting groups.|10 weeks, 28 weeks|Randomized participants with a PARS severity score for GAD during the acute treatment period and at least 1 PARS severity score for GAD during the extension treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404461|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Reported as percentage of participants with treatment-emergent (new or worsening) suicidal behavior from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal behavior score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
1404462|NCT01226511|Secondary|Percentage of Participants During the 10-Week Period With Treatment-Emergent (New or Worsening) Suicidal Ideation as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Results reported as percentage of participants with treatment-emergent (new or worsening) suicidal ideation from baseline=(number of participants with changes compared to baseline/total number of participants at risk)*100."|Baseline up to 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS suicidal ideation score during the acute treatment period, whose baseline maximum C-SSRS suicidal ideation score was <5. Nine (9) participants from 1 site with major quality issues were excluded.|||percentage of participants|||Number
1404476|NCT01226095|Secondary|Number of Participants Who Experienced Adverse Events and Serious Adverse Events|Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 4 weeks|The tolerability population included all enrolled participants.|||participants|||Number
1404463|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)|The CGAS was a clinician-rated assessment of general functioning. CGAS raw scores ranged from 1 (greatest impairment) to 100 (superior functioning). Lower scores indicated a lower level of functioning and greater impairment. Least squares (LS) mean from an analysis of covariance (ANCOVA) was adjusted for treatment, pooled investigator, baseline, and age category.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline [last observation carried forward (LOCF)] CGAS score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404464|NCT01226511|Secondary|Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale|Remission rate was defined as the percentage of participants having a CGI-S score ≤2 at endpoint. The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness.|10 weeks|Randomized participants with at least 1 post-baseline CGI-S score [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
1404465|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|The CGI-S scale evaluated the severity of illness at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicated a greater severity of illness. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline CGI-S score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404466|NCT01226511|Secondary|Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms|PARS severity total score was assessed for all symptoms identified on the PARS symptom checklist. PARS severity total score was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity total scores ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for treatment, pooled investigator, visit, baseline, age category, treatment*visit, baseline*visit, and age category*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity total score during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404467|NCT01226511|Secondary|Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD|Response rate was defined as the percentage of participants having a 50% improvement from baseline to endpoint on the PARS severity score for GAD. PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD [last observation carried forward (LOCF)] during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||percentage of participants|||Number
1404468|NCT01226511|Primary|Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist|PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit, and baseline*visit.|Baseline, 10 weeks|Randomized participants with a baseline and at least 1 post-baseline PARS severity score for GAD during the acute treatment period, excluding 9 participants from 1 site with major quality issues.|||units on a scale||Standard Error|Least Squares Mean
1404469|NCT01226459|Primary|Subject Assessment of Scalp Coverage|Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.|Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Eighteen participants in vehicle foam group and 23 participants in minoxidil foam group had no scalp coverage information.|||scores on a scale||Standard Deviation|Mean
1404470|NCT01226459|Secondary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 12|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in the vehicle foam group and 3 participants in the minoxidil foam group had no hair count information at Baseline.|||hairs per centimeter squared||Standard Error|Mean
1404471|NCT01226459|Primary|Target Area Hair Count|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in minoxidil foam group had no hair information at Baseline.|||hairs per centimeter squared||Standard Deviation|Mean
1404539|NCT01225835|Secondary|Estradiol (E2) Levels on Day of hCG Administration||approximately day 10|Per protocol set. Five participants from each treatment arm were missing blood samples.|||ng/ml||Standard Deviation|Mean
1404477|NCT01226095|Secondary|Number of Participants With the Ability to Carry Out Normal Activities at Each Visit|The number of participants who were able or unable to carry out normal activities was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||participants|||Number
1404478|NCT01226095|Secondary|Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)|The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.|2 and 4 weeks|Data were analyzed for all participants for which data were available.|||participants|||Number
1404479|NCT01226095|Primary|Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).|Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit. The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.|4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||Participants|||Number
1404480|NCT01226095|Secondary|Duration of Morning Stiffness|The duration of morning stiffness in minutes was assessed at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, however, only participants with available morning stiffness data were included in the analysis for each visit.|||minutes||Standard Deviation|Mean
1404481|NCT01226095|Secondary|Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).|Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.|2 and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||Participants|||Number
1404482|NCT01226095|Secondary|Number of Participants With Joint Tenderness/Stiffness at Each Visit|Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.|Baseline, 2 weeks, and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||participants|||Number
1404483|NCT01226095|Secondary|Percent of Participant Compliance|The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit. Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).|2 and 4 weeks|Compliance was calculated for all participants using the dose actually taken and the dose that should have been taken.|||percentage of participant compliance|||Number
1404484|NCT01226095|Primary|Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.|Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline. The overall mean pain score was calculated for participants who completed the study at each visit.|Baseline and 4 weeks|Effectiveness data were analyzed using the intent-to-treat (ITT) and per-protocol (PP) populations, each of which consisted of all 519 enrolled participants.|||units on a scale||Standard Deviation|Mean
1404485|NCT01226043|Other Pre-specified|Number of Patients With Hypoglycemic Events|The hypoglycemic event was to be recorded on the electronic case report form hypoglycemia page and had to fit in one of the following categories: Mild-to-moderate hypoglycemia (36 mg/dL ≤ Self Monitored Blood Glucose (SMBG) <70mg/dL), Severe hypoglycemia (assistance of another person is required, and either a recorded SMBG <36 mg/dL, or treatment with oral carbohydrates, intravenous glucose or glucagon with prompt response) or Hypoglycemia symptoms with or without SMBG values with a documented SMBG >70 mg/dL, or no recorded SMBG value. Only hypoglycemia events associated with coma, loss of consciousness or seizure were considered serious adverse event (SAEs).|each study phase (crossover, re-randomization, observational) up to 40 weeks|The safety population for each phase (crossover, re-randomization, observational) was the total treated population defined as all the patients who were randomized and exposed to at least one dose of Lantus during that phase.|||participants having reported the event|||Number
1404486|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Observational Phase||From week 10 to week 40 (observational phase)|Re-randomized population at week 4 and included in the observational phase at week 10 and exposed to at least one dose of the IP|||percentage of patients|||Number
1404487|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase||From week 4 to week 10 (re-randomization phase)|Re-randomized population at week 4 exposed to at least one dose of the IP|||percentage of patients|||Number
1404488|NCT01226043|Secondary|Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase||From baseline to week 4 (crossover phase)|Randomized population (crossover phase) exposed to at least one dose of the IP|||percentage of patients|||Number
1404489|NCT01226043|Secondary|Time to First Observation of HbA1c <7%||From week 10 to week 40 (observational phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of HbA1c.|||Days since Re-randomization (week 4)||95% Confidence Interval|Median
1404490|NCT01226043|Secondary|Percentage of Patients Achieving HbA1c Goal|Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)|measured at week 40 or at study discontinuation|Patients from the mITT population for Re-randomization and Observational Phases who had at least one post re-randomization assessment of HbA1c.|||percentage of patients|||Number
1404491|NCT01226043|Secondary|Change in Lantus Dose Injected Per Day||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG.|||U (insulin unit)||Standard Error|Least Squares Mean
1404492|NCT01226043|Secondary|Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL||At week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had a re-randomization baseline assessment FPG > or = 110 (week 4) and at least one post re-randomization assessment of FPG.|||percentage of patients|||Number
1404493|NCT01226043|Secondary|Change in Fasting Plasma Glucose (FPG)||From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)|The mITT population for Re-randomization and Observational Phases consisted of all patients who were re-randomized, received at least one dose of Lantus after re-randomization, and had both a re-randomization baseline assessment and at least one post re-randomization assessment of FPG measured during the on-treatment period.|||mg/dL||Standard Error|Least Squares Mean
1404494|NCT01226043|Secondary|Healthcare Professional's (HCP) Recommendation|"The overall recommendation score was obtained from the question 20d of the Healthcare Professional Questionnaire: “Overall, how strongly would you recommend each of the insulin delivery systems for your patients?”~5 points scale: from 1= Not Recommended to 5= Recommended"|At week 4 (end of crossover phase)|"The HCP Questionnaire analysis population consisted of HCPs:~who treated at least 1 randomized patient during the crossover phase and this(these) patient(s) received at least one dose of Lantus via both insulin delivery systems during the crossover phase~who completed the HCP Questionnaire."|||units on a scale||Full Range|Median
1404495|NCT01226043|Secondary|Patient Preference Composite Score|"The patient preference composite score was the sum of the scores of the 3 following individual preference questions from the Patient preference Questionnaire:~Question 14a: How strongly do you prefer each of these insulin delivery systems to control blood sugar?~Question 14b: If using insulin for the first time, how strongly would you prefer using each of these delivery systems to overcome reluctance to use insulin?~Question 14c: How strongly would you prefer each insulin delivery system for long-term use?~Each individual question scored from 1 to 5. The lowest score 1 indicated 'Not Preferred' and the highest score 5 indicated 'Always Preferred'. Therefore the total range of the composite score was 3 to 15."|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered to the 3 questions 14a, 14b and 14c.|||units on a scale||95% Confidence Interval|Least Squares Mean
1404496|NCT01226043|Primary|Patient Overall Preference|"The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d “Overall, what is your level of preference for each of the insulin delivery systems?”~5 points scale: from 1=Not preferred to 5= Always preferred"|At week 4 (end of crossover phase)|The modified intent-to-treat (mITT) population for the Patient Preference Questionnaire analysis consisted of all randomized patients who received at least one dose of Lantus via both insulin delivery systems and completed the questionnaire at Week 4. This analysis included patients who answered question 14d.|||units on a scale||95% Confidence Interval|Least Squares Mean
1404497|NCT01225991|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|Resilience: the Connor-Davidson Resilience scale (CD-RISC) quantifies stress coping ability. The CD-RISC is a 25-item self-administered scale, although where necessary, a staff professional could read out each question to the subject and record the answer. The subject is directed to respond to each question with reference to the previous month, understanding that if a particular situation has not arisen in this time, then the response should be determined by how the person thinks they would have reacted. Scoring of the full 25 item scale is based on summing the total of each item, which is scored from 0-4. The full range is therefore from 0 to 100, with higher scores reflecting greater resilience. The outcome measure is a change score from Week 1 to Week 12.|Change Scores from Week 1 to Week 12||||units on a scale||Standard Deviation|Mean
1404498|NCT01225991|Secondary|Profile of Mood States (POMS)|Depressive symptoms: Repeated assessment of depressive symptoms severity will be made using the Profile of Mood States (POMS). The scale consisted of 65 adjectives rated on 5-point scale 0= not at all; 1=a little; 2=moderately; 3=quite a bit; 4=extremely. Five subscales were included in analysis: tension-anxiety (9 items, score range: 0-36), depression (15 items, range 0-60), friendliness (12 items, range 0-48), vigor-activity (8 items, range 0-32), and fatigue (7 items, range 0-28). Higher vigor-activity and friendliness scores reflect a good mood or emotion (high scores indicating better outcomes), and low scores in the other subscales (tension, depression, and fatigue) reflect a good mood or emotion (low scores indicating better outcomes).|Week 1 and 12||||units on a scale||Standard Deviation|Mean
1404499|NCT01225991|Secondary|(UKU) Side Effects Rating Scale Profile|The UKU assessment will rate the number of participants with emerging adverse events.|Weeks 1-4, 6, 8, 10, 12||||Participants|||Count of Participants
1404500|NCT01225991|Secondary|Visual Analogue Scale to Evaluate Fatigue (VAS-F)|The Visual Analogue Scale to Evaluate Fatigue (VAS-F) is an assessment of fatigue severity. The Visual Analogue Scale (VAS) measures a characteristic or attitude that ranges across a continuum of values from none (0) to an extreme amount of fatigue and energy (10). Scores fall between 0 and 10 anchored by word descriptors at each end and the patient marks on the line the point that they feel represents their perception of their current state. The scale consists of 18 items relating to the subjective experience of fatigue. Two subscales are summed separately and reported as follows: Items 1-5 and 11-18 represent fatigue from none (0) to extreme fatigue (10) and items 6-10 represent energy from none (0) to extreme energy (10). The outcome measures the change scores of energy and fatigue from Week 1 to Week 12. The VAS subscales for Fatigue Scale range: 0-130 and Energy Scale range: 0-50 with higher scores indicating greater energy and fatigue.|Change scores from Week 1 to Week 12 of energy and fatigue||||units on a scale||Standard Deviation|Mean
1404540|NCT01225835|Secondary|Endometrial Thickness on Day of hCG Administration|Endometrial thickness was assessed by pelvic ultrasound on the day of hCG administration.|approximately day 10|Per protocol set of participants. One participant in the Follitrophin Alpha arm was missing a measurement.|||mm||Standard Deviation|Mean
1404501|NCT01225991|Primary|Pain Rating Index|The Pain Rating Index ranked values associated with adjectives depicting the severity of pain from the McGill Pain Questionnaire (MPQ). The assessment is comprised of 15 adjectives, each of which is scored on a scale ranging from 0 (none) to 3 (severe) and summed to arrive at a score ranging from 0 (no pain) to 45 (worst possible pain), to measure the extent of pain/tenderness and swelling. The Pain Rating Index final scores were averaged to indicate an overall report of joint pain and stiffness.|Change score at baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1404502|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404503|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404504|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404505|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404506|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404507|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404508|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404509|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404510|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404511|NCT01225952|Secondary|Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)|In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404541|NCT01225835|Secondary|Number of Frozen Oocytes at Pronuclear Stage|No more than three normally developed embryos were transferred 2-3 days after oocyte retrieval. Other normally developed embryos were frozen.|approximately day 14|Per protocol set of participants who had embryos transferred|||oocytes||Standard Deviation|Mean
1404512|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404513|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404514|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404515|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404516|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404517|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404518|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404519|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404520|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404521|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 4 (day 120-180)||||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404522|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404581|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 6 ([post dose] 7 hours post allergen challenge)||||Percentage||Standard Deviation|Mean
1404523|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404524|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404525|NCT01225952|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)|In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units||Standard Deviation|Mean
1404526|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set, non-missing|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404527|NCT01225952|Primary|Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)|A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity.|Postoperative visit 3 (day 30-60)|Full Analysis Set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1404528|NCT01225926|Primary|Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3|Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.|Month 3|Per protocol: All subjects who received IOLs in both eyes and followed the protocol with no major protocol deviations.|||logMAR||Standard Deviation|Mean
1404529|NCT01225887|Secondary|Progression Free Survival|the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.|The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 years|The time in months that a patient survived progression-free.|||months||90% Confidence Interval|Median
1404530|NCT01225887|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1404531|NCT01225887|Primary|Progression-free Survival > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|for disease that can be evaluated by physical exam, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1404532|NCT01225887|Primary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1|For disease that can be evaluated by physical exam,response was assessed prior to each cycle CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1404533|NCT01225887|Primary|Number of Participants With Adverse Events|The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0|Up to 5 years|Patients on study who experienced adverse events (Grade 3 or higher)|||Participants|||Count of Participants
1404534|NCT01225835|Secondary|Summary of Pregnancy Outcome|Pregnancy outcomes were reported at the optional long-term follow up visit.|up to 10 months|Per protocol set of participants who reported information during the optional long-term follow up visit.|||participants|||Number
1404535|NCT01225835|Secondary|Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test|A pelvic ultrasound scan was performed approximately 6 weeks after the first positive pregnancy test and the presence of an active foetal heart action indicated a clinical pregnancy.|approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test|Per protocol set|||percentage of participants|||Number
1404536|NCT01225835|Secondary|Number of Ampoules of Gonadotrophins Used|Number of ampoules of gonadotrophins used with the goal of reaching hCG criteria. Each ampoule contained 75 IU of either menotrophin or follitrophin alpha.|Day 1 up to Day 12|Per protocol set|||ampoules||Standard Deviation|Mean
1404537|NCT01225835|Secondary|Number of Days Stimulated With Gonadotrophins|Number of days in which gonadotrophins were administered until hCG criteria were met. If hCG criteria were not met by day 13, the participant was withdrawn from the study.|Day 1 up to Day 12|Per protocol set|||days||Standard Deviation|Mean
1404538|NCT01225835|Secondary|Percentage of Participants With Successful Embryo Transfer||approximately day 18|Per protocol set|||percentage of participants|||Number
1404542|NCT01225835|Secondary|Best Quality of an Embryo Transferred|"Embryo quality was measured by the following grades:~Grade 1: Evenly sized cells, regular cleavage, no fragmentation~Grade 2: Regular or slightly irregular cleavage, <=20% fragmentation~Grade 2.5: Regular or slightly irregular cleavage, >20%and <=50% fragmentation~Grade 3: Irregular cleavage, >50% fragmentation, >1 intact cell~Grade 4: Extensive fragmentation, only 1 cell intact~Grade 5: Totally fragmented, no viable cells.~Grade 1 represents the healthiest embryos and Grade 5 embryos are not viable."|approximately day 14|Per protocol set of participants who had embryos transferred|||participants|||Number
1404543|NCT01225835|Secondary|Number of Embryos Transferred|Mean number of embryos transferred 2-3 days following oocyte retrieval.|approximately day 14|The per-protocol (PP) set who had embryos transferred. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||embryos||Standard Deviation|Mean
1404544|NCT01225835|Secondary|Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade|"The count of participants with different quality grades of pronuclear stage oocytes is offered. Pronuclear stage oocytes are categorized into seven grades (0A, 0B, 1-5) representing different patterns of pronuclear morphology, according to the German Pronuclear Morphology Study Group. 0A is the highest quality oocyte and grade 5 is the lowest quality.~Participants can have pronuclear stage oocytes of different grades and therefore are counted more than once."|approximately day 13|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||participants|||Number
1404545|NCT01225835|Secondary|Number of Pronuclear Oocytes|Pronuclear oocytes are fertilized oocytes.|approximately day 13 after study start|The per-protocol (PP) set of participants with non-missing values.|||oocytes||Standard Deviation|Mean
1404546|NCT01225835|Secondary|Number of Cumulus-oocyte Complexes Retrieved|Cumulus-oocyte complexes are oocytes with surrounding cumulus cells.|approximately day 12 after study start|The per-protocol (PP) set of participants with non-missing values.|||oocytes||Standard Deviation|Mean
1404547|NCT01225835|Secondary|Average Follicle Diameter at hCG Administration||approximately day 10|The per-protocol (PP) set of participants with non-missing values.|||mm||Standard Deviation|Mean
1404548|NCT01225835|Secondary|Number of Follicles at hCG Administration|Number of follicles >=17 mm diameter detected by pelvic ultrasound examination at day of hCG administration.|approximately day 10|The per-protocol (PP) set of participants with non-missing values. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||follicles||Standard Deviation|Mean
1404549|NCT01225835|Secondary|Percentage of Participants With Ongoing Pregnancy|Ongoing pregnancy is defined as having a positive foetal heart action nine or more weeks after the first positive pregnancy test.|approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test)|The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint).|||percentage of participants|||Number
1404550|NCT01225835|Secondary|Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration|The influence of the progesterone level on the ongoing pregnancy rate (in relation to all randomized patients) was determined by means of the receiver operating characteristic (ROC) curve. Youden's Index (sensitivity + specificity -1) has a range of 0-1, with 0.5 indicating a random effect.|Day 7, approximately Day 10 (hCG Administration)|Full analysis set|||Youden's index|||Number
1404551|NCT01225835|Primary|Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration|Ovulation induction was performed by administration of hCG once three follicles >=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (<39 years and >=39 years).|approximately day 10|Full analysis set|||ng/ml||Standard Deviation|Mean
1404552|NCT01225822|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval|Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.|up to day 8+/-2 days visit||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1404553|NCT01225822|Secondary|Plasma Concentration (Cmax) of Dabigatran|"Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state.~Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state.~Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state"|Day 1 to end of treatment||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1404554|NCT01225822|Secondary|Laboratory Analyses|"Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range.~Normal ranges are defined as:~Haematocrit [%]: (0.35-0.45) for women and (0.39−0.51) for men Haemoglobin [g/dL]: (11.6−15.4) for women and (13.2−17.3) for men White Blood Cell count [10^9/L]: (4-10.3) for women and (3.9−10.3) for men Platelets [10^9/L]: (145-420) for women and men Sodium [mmol/L]: (135-146) for women and men Potassium [mmol/L]: (3.5-5) for women and men Aspartate aminotransferase (AST) [U/L]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) [U/L]: (8-43) for women and (8-45) for men Alkaline Phosphatase [U/L]: (36-118) for women and (35-123) for men Creatinine [mg/dL]: (0.57-1.06)for women and (0.72−1.3) for men Bilirubin, total [mg/dL]: (0.22-1.28) for women and men Uric acid [mg/dL]: (2.4-6.47) for women and men"|Screening to end of treatment|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||participants|||Number
1404582|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 5 (post dose)|PD Analysis set|||Percentage||Standard Deviation|Mean
1404583|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 7 ([post-dose] 24 hours post allergen challenge)||||mg/mL||Full Range|Geometric Mean
1404555|NCT01225822|Secondary|Number of Participants With Clinically Significant, Minor or Any Bleeding Events|"Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as~Spontaneous skin haematoma larger than >25 cm²~Wound haematoma >100 cm²~Spontaneous nose bleed >5 minutes~Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention~Spontaneous rectal bleeding (more than spot on toilet paper)~Gingival bleeding >5 minutes~Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events."|Treatment period (up to day 8+/-2 days visit)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||participants|||Number
1404556|NCT01225822|Secondary|Rate of Transfusions Due to Bleedings|Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||Percentage of patients|||Number
1404557|NCT01225822|Secondary|Volume of Blood Loss|Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre.|Day 1 (Day of surgery)|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||ml||Standard Deviation|Mean
1404558|NCT01225822|Primary|Number of Participants With Major Bleeding Events (MBE)||From approximately 14 days prior to surgery to 4-6 weeks post surgery|Safety Set (SAFE) population. This included all randomised patients who were treated and who had any available data|||participants|||Number
1404559|NCT01225822|Secondary|Number of Participants With Proximal DVT|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
1404560|NCT01225822|Secondary|Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality|Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period or PE confirmed by objective testing plus VTE related mortality|Treatment period (up to day 10)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
1404561|NCT01225822|Secondary|Number of Participants With VTE Events and All Cause Mortality|Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths.|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
1404562|NCT01225822|Primary|Number of Participants With Venous Thromboembolic (VTE) Events|Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing|Treatment period (up to day 8+/-2 days visit)|Full Analysis Set (FAS) population. This included all randomised patients who had at least one subcutaneous injection and one oral dose of study medication and with confirmed VTE data post surgery|||participants|||Number
1404563|NCT01225731|Primary|Number of Particpants Discontinuing Study Treatment Due to Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.|Up to 52 weeks|All particpants receiving at least one dose of study drug during the treatment period.|||Participants|||Number
1404564|NCT01225731|Primary|Number of Participants Experiencing Adverse Events|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 72 weeks|All participants receiving at least one dose of study drug.|||Participants|||Number
1404565|NCT01225731|Secondary|Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.|||Percentage of participants|||Number
1404566|NCT01225731|Secondary|Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint, excluding all participants on the placebo arm.|||Percentage of participants|||Number
1404584|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 5 ([post-dose] pre allergen challenge)||||mg/mL||Full Range|Geometric Mean
1405010|NCT01220466|Other Pre-specified|Percentage of Eyes With Manifest Refraction Spherical Equivalent Within 1.0 D||6 months|Percent of eyes that achieved manifest refraction spherical equivalent within 1.0 D|||percentage of eyes|Participants|95% Confidence Interval|Number
1404567|NCT01225731|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.|||Score on a scale||95% Confidence Interval|Mean
1404568|NCT01225731|Secondary|Percentage of Participants With PASI 50 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 50 response was defined as >=50 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
1404569|NCT01225731|Secondary|Mean Change From Baseline in PASI Score at Weeks 12 and 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).|Baseline and Weeks 12 and 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for Week 12 and Week 16.|||Score on a scale||95% Confidence Interval|Mean
1404570|NCT01225731|Secondary|PASI 75 Response Rate by Time|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score at Week 2, 4, 6, 8, 12, or 16.|Up to 16 Weeks|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. and data for the specific Week.|||Percentage of participants|||Number
1404571|NCT01225731|Secondary|Percentage of Participants With PASI 100 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data fior this endpoint|||Percentage of participants|||Number
1404572|NCT01225731|Secondary|Percentage of Participants With PASI 90 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 90 response was defined as >=90 % improvement in PASI score when compared to the baseline score.|Week 16|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint.|||Percentage of participants|||Number
1404585|NCT01225549|Secondary|Airway Hyperresponsiveness by Assessment of Methacholine PC20|The methacholine challenge was performed on Day 1 (pre dose), Day 5 ([post dose] pre AC), and Day 7 ([post dose] 24 hours post AC)|Day 1 (pre-dose)|PD Analysis set|||mg/mL||Full Range|Geometric Mean
1404586|NCT01225549|Secondary|Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge|AUC was assessed as average percentage of FEV1 remaining 0 to 3 hours and 3 to 7 hours post allergen challenge compared to pre allergen challenge FEV1|From Randomization to end of treatment|PD Analysis set|||Percentage||Full Range|Geometric Mean
1404573|NCT01225731|Secondary|Percentage of Participants With Physician’s Global Assessment (PGA) of “Cleared” or “Minimal” at Week 16|The PGA is used to determine the overall severity of a subject’s psoriasis lesions at a given time point. Overall lesions will be graded for induration, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PGA value was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
1404574|NCT01225731|Secondary|Percentage of Participants With a PASI 75 Response at Week 12|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 12|The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
1404575|NCT01225731|Primary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16|The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as >=75% improvement in PASI score when compared to the baseline score.|Week 16|The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.|||Percentage of participants|||Number
1404576|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients|A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug|First dosing up to 48 months|The safety analysis set defined as all patients who took at least one dose of study drug|||Percentage of Patients|||Number
1404577|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization|Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment|||Percentage of Patients|||Number
1404578|NCT01225562|Secondary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization|Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment|||Percentage of Patients|||Number
1404579|NCT01225562|Primary|Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization|Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization|Randomization up to 47 months|Intention to treat (ITT) population defined as all participants who were randomized to study treatment|||Percentage of Patients|||Number
1404580|NCT01225549|Secondary|Changes in Sputum Eosinophils Differentials (Percentage)|The change form baseline in percentage of sputum eosinophils was assessed on Day 5 (post dose) ,Day 6 ([post dose] 7 hours post allergen challenge) and Day 7 ([post dose] 24 hours post allergen challenge)|Day 7 ([post dose] 24 hours post allergen challenge)||||Percentage||Standard Deviation|Mean
1405011|NCT01220466|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better.||6 months|UCVA is reported as percentage of eyes not percentage of subjects achieving UCVA of 20/40 or better|||percentage of eyes|Participants|95% Confidence Interval|Number
1404588|NCT01225549|Primary|Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1|LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1|From Randomization to end of treatment|PD Analysis set|||Percentage||Full Range|Geometric Mean
1404589|NCT01225354|Secondary|Aesthetic Improvement|Subject and Investigator will complete GAIS at Visits 2-4 comparing overall appearance of current visit’s photo to baseline photo|Visit 2-4|||||||
1404590|NCT01225354|Secondary|Assessment of Malar Deficiency|Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale.|Visit 1-4|||||||
1404591|NCT01225354|Secondary|Subject First Impression|Each subject will complete the 10-point (1-Not at all to 10-Very Much) evaluating their own first impression at Baseline, Visit 2 (if applicable), Visit 3, and Visit 4.|baseline, Visit 2, Visit3, and Visit 4||2013-12-31|12/2013||||
1404592|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|2 weeks post optimal cosmetic result||||Participants with improved self-esteem|||Number
1404593|NCT01225354|Primary|Self-esteem|Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations.|1 month post-optimal cosmetic result|All subjects completing indicated visit|||Participants with improved self-esteem|||Number
1404594|NCT01225354|Primary|Blinded Evaluations of First Impression|Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of each of the 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria.|After the 1-month post optimal correction visit for subject 20|||||||
1404595|NCT01225289|Secondary|Peripheral Blood Mononucleated Cells (PBMCs) Proliferation Assay (BrdU Colorimetric)|difference of PBMCs proliferation stimulated with myelin oligodendrocyte glycoprotein (MOG), before and after of supplementation|first day and after 6 month||||absorbance units||Standard Error|Mean
1404596|NCT01225289|Secondary|Difference of Retinol Binding Protein (RBP) / Transthyretin (TTR) Ratio, (Difference of RBP/ TTR Ratio), Before and After of Supplementation||first day and after 6 month||||ratio||Standard Error|Mean
1404597|NCT01225289|Secondary|Difference of IL-4 Levels in Supernatant of Peripheral Blood Mononucleated Cells (PBMCs) Stimulated With Phytohemagglutinin (PHA), Before and After of Supplementation||first day and after 6 month||||pg/ml||Standard Error|Mean
1404598|NCT01225289|Primary|Difference Serum Levels of High-sensitive C-reactive Protein (Hs-CRP), Before and After of Supplementation||first day and after 6 month||||mg/L||Standard Error|Mean
1404599|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24||Weeks 13 to 24||||days||Inter-Quartile Range|Median
1404600|NCT01225263|Primary|Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12||Weeks 1 to 12||||days||Inter-Quartile Range|Median
1404601|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Weight at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||kg||Standard Error|Least Squares Mean
1404602|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||kg/m^2||Standard Error|Least Squares Mean
1404603|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56|CFQ-R respiratory domain is defined in Outcome Measure 17.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||units on a scale||Standard Error|Least Squares Mean
1404604|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||units on a scale||95% Confidence Interval|Least Squares Mean
1404605|NCT01225211|Secondary|Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||percent change||Standard Error|Least Squares Mean
1404606|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.|||percent change||95% Confidence Interval|Least Squares Mean
1404607|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Baseline, Day 28 and 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1404608|NCT01225211|Secondary|Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||percent change||95% Confidence Interval|Least Squares Mean
1404609|NCT01225211|Secondary|Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1404610|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21|FEV1 and ppFEV1 are defined in Outcome Measure 6.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1404611|NCT01225211|Secondary|Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||liters||95% Confidence Interval|Least Squares Mean
1404612|NCT01225211|Secondary|Cohort 4: Absolute Change From Baseline in Sweat Chloride at Day 56||Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||Standard Error|Least Squares Mean
1404613|NCT01225211|Secondary|Cohort 2 And 3: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 2: Baseline, Day 14|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||95% Confidence Interval|Least Squares Mean
1404614|NCT01225211|Secondary|Cohort 1: Absolute Change From Baseline in Sweat Chloride at Day 14||Cohort 1: Baseline, Day 14|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||95% Confidence Interval|Least Squares Mean
1404615|NCT01225211|Primary|Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Hankinson method.|Cohort 4: Baseline, Day 56|Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.|||percent predicted of FEV1||Standard Error|Least Squares Mean
1404616|NCT01225211|Primary|Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56||Cohort 2 and 3: Day 28, Day 56|Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||mmol/L||95% Confidence Interval|Least Squares Mean
1404617|NCT01225211|Primary|Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21||Cohort 1: Day 14, Day 21|Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1404618|NCT01225211|Primary|Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs|AEs and SAEs are defined in Outcome Measure 1.|Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 4 Safety Set included all participants who received at least 1 dose of study drug in Cohort 4.|||participants|||Number
1404619|NCT01225211|Primary|Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)|Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56).|Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)|Cohort 2 and 3 Safety Set included all participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.|||participants|||Number
1404620|NCT01225211|Primary|Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).|Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)|Cohort 1 Safety Set included all participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.|||participants|||Number
1404621|NCT01225159|Secondary|Morbidities and All Causes Mortality|morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)|within the first 30 days after surgery||||participants|||Number
1404622|NCT01225159|Primary|Nosocomial Infection|Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.|within the first 30 day after surgery||||participants|||Number
1404623|NCT01225146|Secondary|Goldman Visual Field Changes|Goldman Visual Field changes at 6 and 12 months from baseline|12 months|Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)||||||
1404624|NCT01225146|Secondary|Changes, by Disc Areas, of Capillary Non-perfusion in the Periphery|Changes, by disc areas, of capillary non-perfusion in the periphery (evaluated by wide-field fluorescein angiography) at 3, 6, 9 and 12 months from baseline.|12 months|Data for this outcome measure were not collected. The study was terminated because the collaborator, Genentech, stopped production of the study drug (2.0 mg ranibizumab). Analysis of this outcome was therefore deferred and is being rolled over to the WAVE study program (NCT01710839, IND 12246)||||||
1404625|NCT01225146|Secondary|Mean Change in Central Foveal Volume|Mean change in Central Foveal Volume on High Resolution OCT|12 months|Patients in cohort 2 did not complete the study.|||mm^3||Full Range|Mean
1404626|NCT01225146|Secondary|Neovascularization Development|Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.|12 months|Patients in cohort 2 did not complete the study.|||Percentage of patients|||Number
1404627|NCT01225146|Secondary|Incidence and Severity of Adverse Events (Ocular and Non-ocular).|Incidence and severity of adverse events (ocular and non-ocular) from baseline through 12 months will be evaluated.|12 months||||incidents|||Number
1404628|NCT01225146|Primary|Mean Change in logMAR|Mean change from baseline in ETDRS NCVA.|12 months.|Patients in cohort 2 did not complete the study.|||logMAR||Full Range|Mean
1404629|NCT01225068|Primary|Effect Size of VAS Pain|"Effect size (ES) calculation for VAS pain between milnacipran and placebo groups' ES is dimensionless; Visual analogue scale (VAS) measured pain in integral units from 0 (low end) to 100 (high end); ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (determined at baseline and 6 weeks here) divided by the pooled standard deviation.~This is the primary outcome measure."|6 weeks from baseline|per protocol|||units on a scale||Standard Deviation|Mean
1404630|NCT01225055|Secondary|Amino-terminal Propeptide of Type 1 Collagen|The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.|||ng/ml||Standard Deviation|Mean
1404631|NCT01225055|Secondary|Bone-specific Alkaline Phosphatase|The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy|Baseline to 12 Months|One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.|||ng/ml||Standard Deviation|Mean
1404632|NCT01225055|Secondary|C-terminal Telopeptide|The mean change in C-terminal telopeptide from baseline after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy from the Teriparatide and Vibration group. One sample was lost due to laboratory error. The samples from the Hines location (n=11) were also not included in this analysis. This accounts for the 13 subjects that were not analyzed.|||ng/ml||Standard Deviation|Mean
1404633|NCT01225055|Secondary|Bone Mineral Density (BMD) by DXA at Femoral Neck|The mean change in BMD of the femoral neck after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. One additional subjects was not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 13 subjects that were not analyzed.|||g/cm^2||Standard Deviation|Mean
1404634|NCT01225055|Secondary|Bone Mineral Density (BMD) by DXA at the Lumbar Spine.|The mean change in BMD at the lumbar spine from baseline after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Five additional subjects were not analyzed due to metal artifacts that interfered with analysis. This accounts for the 17 subjects that were not analyzed.|||g/cm^2||Standard Deviation|Mean
1404635|NCT01225055|Primary|Bone Mineral Density BMD of the Total Hip as Assessed by DXA.|The mean change in BMD of the total hip after 12 month of treatment|Baseline to 12 Months|One subject withdrew prior to receiving therapy. The samples from the Hines location (n=11) were also not included. Two additional subjects were not analyzed due to metal artifacts or heterotopic ossification that interfered with analysis. This accounts for the 14 subjects that were not analyzed.|||g/cm^2||Standard Deviation|Mean
1404636|NCT01225029|Secondary|Time to First Enteral Feed||hour until first enteral feed achieved, an average of approximately 40 hours and a maximum of 100 hours||||hours||Inter-Quartile Range|Mean
1404637|NCT01225029|Secondary|Duration of ICU Admission||every day until discharge, an average of approximately 8 days and a maximum of 12 days||||calendar days||Inter-Quartile Range|Mean
1404638|NCT01225029|Primary|Duration of Respiratory Support||every hour until patient stable without respiratory support, an average of approximately 55 hours and a maximum of 205 hours||||hours||Inter-Quartile Range|Median
1404639|NCT01224821|Secondary|Time to Disease Progression or Death for All Participants, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants with disease progression or those who died were analyzed.|||months||95% Confidence Interval|Median
1404640|NCT01224821|Secondary|Time to Disease Progression or Death for Responders, as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only participants classified as responders with disease progression or those who died were analyzed.|||months||95% Confidence Interval|Median
1405012|NCT01220414|Primary|Time for Subject to Reach Pain Threshold||Baseline||||seconds||Standard Deviation|Mean
1404641|NCT01224821|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause. Time to death is the time from the dosimetric dose to the date of death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants who died during the study were analyzed.|||months||95% Confidence Interval|Median
1404642|NCT01224821|Secondary|Median Time to Treatment Failure for All Participants|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population|||months||95% Confidence Interval|Median
1404643|NCT01224821|Secondary|Duration of Response for All Unconfirmed Clinical Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.|||months||95% Confidence Interval|Median
1404644|NCT01224821|Secondary|Duration of Response for All Confirmed Clinical Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CCR were analyzed.|||months||95% Confidence Interval|Median
1404645|NCT01224821|Secondary|Duration of Response for All Unconfirmed Complete Responders, as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.|||months||95% Confidence Interval|Median
1404646|NCT01224821|Secondary|Duration of Response for All Confirmed Complete Responders, as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed CR were analyzed.|||months||95% Confidence Interval|Median
1404647|NCT01224821|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.|||months||95% Confidence Interval|Median
1404648|NCT01224821|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants with a confirmed response were analyzed.|||months||95% Confidence Interval|Median
1404649|NCT01224821|Secondary|Number of Participants With Confirmed CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed CR and CCR were analyzed.|||participants|||Number
1404716|NCT01223378|Secondary|Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)|The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)|baseline and Visit 6 (Day 28)|Intent to treat, data as observed (study eye)|||mm Hg||Standard Deviation|Mean
1404650|NCT01224821|Secondary|Number of Participants With CR and CCR, as Assessed by the Investigator|The total number of participants with CR and CCR was reported. CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Clinical Complete Response: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
1404651|NCT01224821|Secondary|Number of Participants With Confirmed Response (CR, CCR, or PR), as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1404652|NCT01224821|Secondary|Number of Participants (Par.) With Response (CR, CCR, or PR), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
1404653|NCT01224821|Secondary|Number of Participants With the Indicated Therapeutic Doses (TD) (Total Body Dose)|Based on their platelet count and body weight. Participants received different TDs of TST. For obese participants (weighing more than 137% of their calculated lean body weight), the calculation to determine the administered activity (mCi) was performed using the maximum effective mass (i.e., the minimum of the participant’s mass and 137% of their calculated lean body weight). The administered activity (mCi) for participants with a Baseline platelet count of 100001–149999 cells/millimeter cubed (mm^3) was reduced to a 65 cGy total body dose, after any adjustment for obesity.|Participants were evaluated for up to 142 months in Study 104731 or were followed in the long-term follow-up study (Study 104526) for up to 136.3 months|ITT Exposed Population|||participants|||Number
1404654|NCT01224821|Primary|Number of Participants Who Received the Therapeutic Dose at the Seven Clinical Research Sites|The dosimetry methods were validated for seven different clinical research sites.|Day 1 within one hour of infusion (I) and prior to urination (U); Days 2, 3, and 4 after dosimetric dose (DD) I, following U; Days 6 and 7 after DD I, following U|Intent-to-Treat (ITT) Exposed Population: all participants who enrolled in the study and received at least one dose of study drug. One participant did not receive the therapeutic dose.|||participants|||Number
1404655|NCT01224782|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.|Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months)|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .|||participants|||Number
1404656|NCT01224782|Secondary|Mean Weekly Dose of Zemplar (Paricalcitol)|Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).|From Baseline up to 12 months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.|||micrograms||Standard Deviation|Mean
1404657|NCT01224782|Secondary|Percentage of Participants With Hypercalcemia|The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.|From Baseline up to 12 months|The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.|||percentage of participants|||Number
1404658|NCT01224782|Secondary|Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)|The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.|||percentage of participants|||Number
1404659|NCT01224782|Primary|Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2|The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.|||percentage of participants|||Number
1404660|NCT01224782|Primary|Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values|Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).|From Baseline up to 12 Months|The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a > 30% decrease in iPTH compared with the initial values at baseline.|||months||Standard Deviation|Mean
1404661|NCT01224678|Primary|Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms|To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.|12 months|86 of the 300 patients were analyzed for the primary endpoint|||percent change||Standard Deviation|Mean
1404662|NCT01224639|Secondary|Titers of Vaccine Viremia||14 Days after each vaccination|Due to the low prevalence of vaccine viremia, estimates of average titer levels of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.||||||
1404663|NCT01224639|Secondary|Duration of Vaccine Viremia||14 Days after each vaccination|Due to the low prevalence of vaccine viremia, estimates of average titer duration of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.||||||
1404664|NCT01224639|Secondary|Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination|Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported.|Baseline and at multiple time points up to Day 14 after each vaccination|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||participants|||Number
1404665|NCT01224639|Secondary|Percentage of Participants With Durability of Immune Response|Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer >=10 where pre-vaccination PRNT 50 titer <10, or post-vaccination PRNT(50) Titer >=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer >=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution.|Days 180 and 270|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||percentage of participants||95% Confidence Interval|Number
1404666|NCT01224639|Secondary|Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination|Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n).|Days 14 and 30 after second vaccination (Days 104 and 120 respectively)|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||percentage of participants||95% Confidence Interval|Number
1404667|NCT01224639|Secondary|Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination|Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit.|Days 14, 30, 60 and 90 after first vaccination|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.|||percentage of participants||95% Confidence Interval|Number
1404668|NCT01224639|Secondary|GMTs of All Four Dengue Serotypes After Second Vaccination|GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.|Days 14 and 30 after second vaccination (Day 104 and 120 respectively)|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing MN Assay samples.|||titer||95% Confidence Interval|Geometric Mean
1404669|NCT01224639|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination|GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.|Days 14, 30, 60 and 90 after first vaccination|The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing microneutralization (MN) Assay samples.|||titer||95% Confidence Interval|Geometric Mean
1404670|NCT01224639|Primary|Number of Participants With Unsolicited Local and Systemic AEs||Baseline up to 30 days after second vaccination (Day 120)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
1404672|NCT01224639|Primary|Number of Participants With Systemic Adverse Events (AEs) by Severity|Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.|Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
1404673|NCT01224639|Primary|Number of Participants With Local Injection Site Reaction by Severity|Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than [>] 15 millimeter [mm]); Moderate as (15-30 mm); Severe (>30 mm), swelling was categorized as Mild (<15 mm); Moderate (15-30 mm); Severe (>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).|Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.|||participants|||Number
1404674|NCT01224626|Primary|Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.|Baseline to 8 weeks|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.|||participants|||Number
1404675|NCT01224626|Secondary|Adverse Drug Reactions Unlisted in Japanese Package Insert.|The adverse drug reactions that have not been included in Japanese package insert.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404676|NCT01224626|Primary|Number of Participants With Adverse Drug Reactions.|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.|Baseline to 8 weeks|Safety analysis population consisted of the participants that satisfied the inclusion and exclusion conditions and in whom administration of this drug was confirmed.|||participants|||Number
1404677|NCT01224444|Secondary|Incomplete Adenoma Resection of Small and Large Adenomas|Comparison of the proportion of incompletely resected adenomatous polyps by size (5-9mm versus 10-20mm).|1 year|||||||
1404678|NCT01224444|Primary|Percent of Incompletely Resected Adenomatous Polyps|Proportion of incompletely resected adenomatous polyps (5 to 20mm), defined by remaining adenomatous tissue in marginal biopsies after snare resection.|1 year||||percentage of incomplete resection|Participants|95% Confidence Interval|Number
1404679|NCT01224431|Secondary|Heart Rate|patient on Cardiopulmonary monitoring|On average the first hour in the emergency department, at 4 time points during lumbar puncture procedure.|||||||
1404680|NCT01224431|Secondary|Length of Cry|cry video recorded and measured after needle stick until pt stopped crying|On average the first hour in the emergency department; from needle stick to end of lumbar puncture|||||||
1404681|NCT01224431|Primary|Pain, Measured as Units on a Scale|Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible|on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.||||units on scale, 0-5||Standard Deviation|Mean
1404682|NCT01224236|Secondary|Transfusions|# of transfusions infants required after enrollment.|enrollment to 36 weeks postmenstrual age (PMA)||||transfusions||Inter-Quartile Range|Median
1404683|NCT01224236|Primary|Hematocrit (Hct)|For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.|36 weeks postmenstrual age (PMA)||||percentage of red blood cells in blood||Standard Deviation|Mean
1404684|NCT01224171|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).~Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?"|From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.|Overall Safety Population|||participants|||Number
1404685|NCT01224171|Secondary|Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation|"Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percent deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|TNFα Antagonist Failure ITT Subpopulation|||percentage of participants||95% Confidence Interval|Number
1404686|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the Overall Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|Overall ITT population|||percentage of participants||95% Confidence Interval|Number
1404687|NCT01224171|Secondary|Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population|"Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission."|Week 6 and Week 10|TNFα Antagonist Failure ITT Subpopulation|||percentage of participants||95% Confidence Interval|Number
1404688|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|Overall ITT population|||percentage of participants||95% Confidence Interval|Number
1404689|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 10|TNFα Antagonist Failure Intent-to-treat (ITT) Subpopulation|||percentage of participants||95% Confidence Interval|Number
1404690|NCT01224171|Secondary|Percentage of Participants in Clinical Remission at Week 6 in the Overall Population|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Overall ITT population, consisting of all randomized participants who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
1404717|NCT01223378|Secondary|IOP </=18mm Hg|Determine the number of subjects with mean diurnal IOP </=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution|Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)|Intent-to-treat population, observed data (study eye)|||Participants|||Count of Participants
1404691|NCT01224171|Primary|Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation|"Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|TNFα Antagonist Failure Intent-to-treat (ITT) subpopulation which consisted of all randomized participants who received any amount of blinded study drug who met the TNFα antagonist failure criterion.|||percentage of participants||95% Confidence Interval|Number
1404692|NCT01224015|Primary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines|The investigator assessed the severity of the patient's Crow’s Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, consisting of all randomized participants with data available for analysis.|||Percentage of participants|||Number
1404693|NCT01223963|Other Pre-specified|Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure|The alternative outcomes were: still satisfied, never satisfied, 3-5 months, 6-8 months, 9-11 months, 12 months or more, still satisfied when retreated.|up to 12 months post-procedure||||participants|||Number
1404694|NCT01223963|Primary|Number of Adverse Events|Number of Adverse events reported during the study period|01may2008 - 31dec2009||||number of AE|||Number
1404695|NCT01223937|Secondary|Minimum Post-Treatment Serum Sodium Levels|Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 up to 3 months|Safety analysis set|||participants|||Number
1404696|NCT01223937|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug.|Day 1 up to 3 months|Safety analysis set|||participants|||Number
1404697|NCT01223937|Secondary|Change From Baseline in 24-Hour Urine Volume at Month 3|"Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
1404698|NCT01223937|Secondary|Change From Baseline in Nocturnal Urine Volume at Month 3|"The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||mL||Standard Deviation|Mean
1404699|NCT01223937|Secondary|Change From Baseline in Mean Time to First Nocturnal Void at Month 3|"The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||minutes||Standard Deviation|Mean
1404700|NCT01223937|Secondary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3|"Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||probability|||Number
1404701|NCT01223937|Secondary|Change From Baseline in Mean Number of Nocturnal Voids at Month 3|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed."|Day 1 (Baseline), Month 3|Full Analysis Set (FAS), including participants with complete data supporting this outcome in the participant diary.|||nocturnal voids||Standard Deviation|Mean
1404718|NCT01223378|Secondary|Change in Mean Diurnal IOP at Visits 4,5, and 7|Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost|Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)|Intent-to-treat population, observed data (study eye)|||mm Hg||Standard Deviation|Mean
1404702|NCT01223937|Primary|Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3|"Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.~This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).|||probability|||Number
1404703|NCT01223937|Primary|Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period|"The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.~Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints."|Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)|Full analysis set (FAS).|||nocturnal voids||Standard Deviation|Mean
1404704|NCT01223703|Secondary|Change in Mean New York Heart Association (NYHA) Functional Class Between Baseline and 12th Month Follow up.|"NYHA class I: No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs, etc...~NYHA class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.~NYHA class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m). Comfortable only at rest NYHA class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|one year||||units on a scale||Standard Deviation|Mean
1404705|NCT01223703|Secondary|Functional Capacity (Change in Peak Oxygen Uptake, VO2)|Change in functional capacity expressed as a peak oxygen uptake (VO2), that was acquired breath-by-breath by pneumotachograph (with bidirectional differential pressure) during cardiopulmonary exercize testing.|one year||||ml/kg/min||Standard Deviation|Mean
1404706|NCT01223703|Secondary|LV Diastolic Function|Change in LV diastolic function assessed by echocardiography: mitral diastolic inflow velocities (peak velocity of early ventricular filling [E-wave], peak velocity of late ventricular filling [A-wave], E/A ratio, and E-wave deceleration time), diastolic function score (graded on a scale from 1 to 4) were used.|one year||||E/A ratio||Standard Deviation|Mean
1404707|NCT01223703|Primary|Change in Left Ventricular (LV) Systolic Function Expressed as Left Ventricular Ejection Fraction (LVEF) Between Baseline and 12-month Follow-up|The primary end point of the study was the change in LV systolic function expressed as LVEF between baseline and 12-month follow-up. The following parameters were measured according to the professional standards defined by the American Society of Echocardiography and the European Association of Echocardiography|one year|A sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with p<0.05 (2-tailed) at the Student t test for unpaired data.|||ejection fraction (percentage)||Standard Deviation|Mean
1404708|NCT01223469|Primary|Number of Subjects With Operative and Post-operative Serious Adverse Events|"For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer.~For AF patients 3 months (±2 weeks)following the index procedure."|3 months for AF arm; 7 days for the right SVT arm||||participants|||Number
1404709|NCT01223404|Secondary|Diastolic Blood Pressure|Diastolic blood pressure in mmHg.|Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application).|Healthy non-smokers (only study completers).|||mmHG||Standard Deviation|Mean
1404710|NCT01223404|Secondary|Systolic Blood Pressure|Systolic blood pressure (mmHg)|Bi-hourly: prior to patch application, 2 hours, 4 hours, and 6 hours after, and after the MRI scan (~8 hours after patch application)|Healthy non-smokers|||mmHG||Standard Deviation|Mean
1404711|NCT01223404|Secondary|Subjective State|"End-of-session subjective state is measured by the Profile of Mood States (POMS). We utilize Total Mood Disturbance (TMD) as a summary measure, derived by adding the total scores on the five negative mood scales (tension, depression, anger, fatigue, confusion) and subtracting the score on the one positive mood scale (vigor). The theoretical range of the TMD scale is -32 to 228, with negative values indicating less mood disturbance, i.e., a more positive emotional state."|1 day|Healthy non-smokers (only study completers).|||units on a scale||95% Confidence Interval|Mean
1404712|NCT01223404|Primary|Default Network Activity|Cognitive task-induced default network deactivation, measured by functional Magnetic Resonance Imaging. The default network was probed by five pre-defined ROIs per hemisphere. Task-induced deactivation was averaged across all ROIs.|1 day|Healthy non-smokers (only study completers).|||percentage of task-induced signal change||95% Confidence Interval|Mean
1404713|NCT01223404|Primary|Signal Detection Performance|Signal detection on cognitive tasks performed in the MR scanner. For the attention task, this represents the percentage of trials in which the participant responded when a signal was presented. In the working memory task (N-back task), this represents the percentage of all target sequences to which the participant responded.|1 day|Healthy adult non-smokers (only study completers).|||percentage of all targets||95% Confidence Interval|Mean
1404714|NCT01223404|Primary|Reaction Time|average reaction time on cognitive task performed in the MR scanner|1 day|18 healthy male and female adult non-smokers. Only study completers are included, due to the within-subject design.|||ms||95% Confidence Interval|Mean
1404715|NCT01223378|Secondary|Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)|The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (points 8 AM, 12 PM, and 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)|baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)|Intent-to-treat, observed data (study eye)|||mm Hg||Standard Deviation|Mean
1404719|NCT01223378|Primary|Change in Mean Diurnal IOP at Visit 6 (Day 28)|Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost|Baseline and Visit 6 (Day 28)|Intent-to-treat population, observed data (study eye)|||mm Hg||Standard Deviation|Mean
1404720|NCT01223365|Secondary|Current Opioid Misuse Measure (COMM) Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status|The COMM was a clinician-rated scale developed as a brief self-report measure of current aberrant drug-related behavior for patients with chronic pain who were already on long-term opioid therapy. A total score was calculated as the sum of the 17 questions. The total score ranged from 0 to 68. A score of 0 indicates no aberrant drug-related behaviors were seen. Patients with a total score of 9 or greater were classified as exhibiting aberrant drug-related behavior.|Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration Period. Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52|Post titration Safety Analysis set|||units on a scale||Standard Deviation|Mean
1404721|NCT01223365|Secondary|Addiction Behavior Checklist (ABC) Total Scores During Both the Open-Label Titration and Open-Label Treatment Periods by Participant Status|The ABC was a clinician rated scale that consisted of a brief (21 item) questionnaire designed to track behaviors characteristic of addiction related to prescription opioid medications in chronic pain populations. Items were focused on observable behaviors noted both during and between clinic visits. Each affirmative response was counted as 1 point, and points were added to calculate the total score. All but 1 of the 21 items (the provider’s impression) was used in calculating the total score, consequently resulting in scores ranging from 0 to 20 (0=no addiction-related behaviors seen and higher scores indicating an increasing number of addition-related behaviors seen). Participants with a total score of 3 or greater were classified as exhibiting inappropriate opioid use during the study.|Baseline for new participants was Day 1 of open-label titration; rollover participants baseline was in study 3079. End of Open-label Titration: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36 40, 44, 48, 52 and last visit up to week 52|Post-titration Safety Analysis set|||units on a scale||Standard Deviation|Mean
1404722|NCT01223365|Secondary|Participants by Risk Category for Aberrant Drug Misuse Based on the Total Score in the Screener and Opioid Assessment for Patients With Pain – Revised (SOAPP-R)|"SOAPP-R is a clinician-rated scale used to assess each patient’s risk of developing aberrant drug use behaviors while on long term opioid therapy. SOAPP-R consists of 24 questions that address 8 concepts: substance abuse history, medication related behaviors, antisocial behaviors/history, psychosocial problems, psychiatric history, physician patient relationship factors, emotional attachment to pain medications, and personal care and lifestyle issues (Butler et al 2008). Each question is answered using a 5 point Likert-like scale, with 0=never, 1=seldom, 2=sometimes, 3=often, and 4=very often for a total range of 0-96. The higher the overall score, the greater the probability the patient is at risk for displaying aberrant behaviors consistent with drug use.~An overall score of 18 or higher is considered positive for predicting aberrant drug related behavior, therefore the reported risk categories are~<18 and~<=18. Results indicate timeframe followed by risk cat"|End of Open-label Titration Period. Weeks 4 and 24 of the Open-label Treatment Period|Safety analysis set|||Participants|||Count of Participants
1404723|NCT01223365|Secondary|Participant Global Assessment (PGA) of the Method of Pain Control by Participant Status|The PGA of the method of pain control consisted of a asking patients a single question to assess their method of pain control during the previous 24 hours as either poor, fair, good, or excellent (Rothman et al 2009).|Baseline for new participants was Day 1, i.e. the first day of open-label titration. Baseline for rollover participants was the baseline in study 3079. Week 4 (end of titration, start of open-label treatment), Week 52, last visit up to Week 52|Full analysis set included all patients in the safety analysis set who had at least 1 postbaseline efficacy assessment. Participants contributing to each time point are listed in the time point label.|||Participants|||Count of Participants
1404724|NCT01223365|Primary|Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status|Pure tone audiometry was performed by trained personnel. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient’s hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (Konrad-Martin et al 2005). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to “no response” at 3 consecutive test frequencies.|Baseline for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periods|Safety analysis set. The endpoint value is from the post-titration safety set (n=42, 92, 157, 291)|||Participants|||Count of Participants
1404725|NCT01223365|Primary|Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status|"A 12-lead ECG was conducted at screening, week 24, and week 52 or at the last postbaseline observation. For rollover participants, the ECG performed at the final visit of study 3079 served as the 1st ECG in study 3080. A qualified physician was responsible for interpreting the ECG. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared with baseline was considered an adverse event.~For overall results, the worst postbaseline finding for the participant was summarized.~Results below are formatted as Baseline ECG result - Overall ECG result."|Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment period|Post-titration Safety analysis set. Only those participants with both baseline and visit electrocardiogram findings were summarized.|||Participants|||Count of Participants
1404757|NCT01223001|Primary|Hamilton Rating Scale for Depression|To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.|9 months|Analysis was not conducted. Study was terminated before interim analysis. Raw data is stored in a secure location, but not able to be accessed.||||||
1404726|NCT01223365|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 of open-label titration period - Week 52 of the open-label treatment period|Safety analysis set. One rollover participant did not have vital signs values.|||Participants|||Count of Participants
1404727|NCT01223365|Primary|Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status|"Data represents participants with PCS abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~alanine aminotransferase (ALT): >=3 times the upper limit of normal (ULN). Normal range is 6-43 U/L~aspartate aminotransferase (AST): >=3 times ULN. Normal range is 9-36 U/L~blood urea nitrogen (BUN): >=10.71 mmol/L~creatinine: >=177 μmol/L~uric acid: M>=625, F>=506 μmol/L~white blood cell count: <=3.0*10^9/L~hemoglobin: M<=115, F<=95 g/dL~hematocrit: M<0.37, F<0.32 L/L~urine blood (hemoglobin): >=2 unit increase from baseline~urine glucose: >=2 unit increase from baseline"|Day 1 - Week 52 of the open-label treatment period|Posttitration Safety Analysis set. The posttitration safety analysis set included all patients who successfully completed the open label titration period and received 1 or more doses of study drug treatment in the open label treatment period.|||Participants|||Count of Participants
1404728|NCT01223365|Primary|Participants With Adverse Experiences|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of open-label titration period - Week 52 of the open-label treatment period|Safety analysis set|||Participants|||Count of Participants
1404729|NCT01223352|Other Pre-specified|Number of Patients With Treatment-emergent Hemoglobin Abnormalities|"Number of patients with marked hemoglobin decreases (absolute values below 10 g/dL). The worst post-baseline value was considered.~The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date."|Baseline, up to Week 24|All randomized patients who received at least one dose of study drug and with available data.|||Participants|||Number
1404730|NCT01223352|Other Pre-specified|Number of Patients With Treatment-emergent Liver Function Abnormalities|Number of patients with increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN). The worst post-baseline value was considered. The treatment-emergent period was defined as study treatment start date up to 7 calendar days after study treatment end date.|Baseline, up to Week 24|All randomized patients who received at least one dose of study drug and with available data.|||Participants|||Number
1404731|NCT01223352|Other Pre-specified|Change From Baseline in Global Clincial Impression Scale (GCIS) at End of Study|The GCIS is an assessment tool providing a single global assessment of the patient’s current overall clinical condition: Very Good, Good, Neither Good or Bad, Bad and Very Bad. The assessment was performed both by the physician and the parents / legal representatives independently. Global clinical impression (GCI) at end of study was compared to GCI at baseline and the number of patients with clinical condition considered as worsened, improved or unchanged are determined.|Baseline, up to Week 24 on average|All-randomized set. Because all 64 randomized patients were treated with at least one dose of study drug, the All-randomized set was identical to the All-treated set.|||Participants|||Number
1404732|NCT01223352|Other Pre-specified|Change From Baseline in WHO Functional Class at End of Study|"The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension (PH):~Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class IIII (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms.~Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined."|Baseline, up to Week 24 on average|All-randomized set. Because all 64 randomized patients were treated with at least one dose of study drug, the All-randomized set was identical to the All-treated set.|||Participants|||Number
1404733|NCT01223352|Other Pre-specified|Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056)|Concentrations of the metabolites were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. Daily exposure to the metabolites corresponds to the area under the concentration-time curve [AUC(0-24)] of the corresponding metabolite over a period of 24 hours, and was calculated in the same manner as the primary endpoint. AUC(0-24c) was corrected to 2 mg/kg (target dose) [AUC(0-24c)].|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1404734|NCT01223352|Other Pre-specified|Time to Reach Cmax [Tmax] of Bosentan|"Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively.~tmax was obtained directly from the measured plasma concentrations."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||hours||Full Range|Median
1404735|NCT01223352|Other Pre-specified|Dose-corrected Maximum Plasma Concentration [Cmaxc] of Bosentan|"Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively.~The peak plasma concentration (Cmax) of bosentan was directly obtained from the measured plasma concentrations and was dose-corrected to the target dose of 2 mg/kg (Cmaxc)."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per-protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||ng/mL||95% Confidence Interval|Geometric Mean
1404736|NCT01223352|Primary|Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan|"Daily exposure was measured by the area under the plasma concentration-time curve over a period of 24 hours [AUC(0-24)].~Concentrations of bosentan were measured directly in blood samples collected prior to study drug administration and up to 8 hours or up to 12 hours post-dose for the t.i.d and b.i.d. dosing regimen, respectively. AUC(0-24) was calculated as a multiple of AUCtau, which is the AUC over a dosing interval (AUCtau x 2 for the b.i.d. dosing regimen and AUCtau x 3 for the t.i.d. regimen). As the smallest dose unit was 8 mg (1/4 tablet), it was not possible to achieve the exact target dose of 2 mg/kg. Therefore, AUC(0-24) was corrected to 2 mg/kg (target dose) [AUC(0-24c)]."|0, 0.5, 1, 3, 5 (or 7.5), 8 (or 12 hours) post-dose at Week 4, after at least 2 weeks of stable study drug treatment|Per-protocol PK analysis set (PK set): All patients included in the bosentan 2 mg/kg b.i.d. and bosentan 2 mg/kg t.i.d. groups who received at least one dose of bosentan and who were able to provide at least 5 blood samples for PK assessments and who did not violate the protocol in a way that might affect the evaluation of the PK main endpoint.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1404737|NCT01223235|Secondary|Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers|Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5mm.|Up to 24 months||||months (Progression Free Survival)||95% Confidence Interval|Median
1404738|NCT01223235|Secondary|Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine|"when given in the presence of bevacizumab~Patients must have IgM titer >1:80, or a fourfold increase in prevailing antibody titer if present at baseline. Twenty-one patients would be accrued, and if >8 of 21 patients should meet these criteria for three or more antigens based on the immune response criteria, the study would be considered positive."|1 year||||% of participants|||Number
1404739|NCT01223235|Primary|Number of Participants With Adverse Events|Toxicities evaluated by CTCAE version 4.0|1 year||||Participants|||Count of Participants
1404740|NCT01223196|Other Pre-specified|Percentage (%) of Haemoglobin A1C|HbA1c (Haemoglobin A1c) is glycosylated haemoglobin, measured as a % of total Hb in red blood cells by a standard biochemical method (HPLC).|6 months||||Percentage (%) of HbA1c||Standard Error|Mean
1404741|NCT01223196|Secondary|Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle.|The activity of TACE is measured by detecting the release of a fluorogenic synthetic substrate of TACE and measuring in a fluorometer. It is expressed in Fluorescence Units (F.U.)|6 months|These individuals completed both the baseline and all intermediate and the end of study visits.|||Tace Activity in F.U./mg prot||Standard Error|Mean
1404742|NCT01223196|Primary|Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp|"Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment.~The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins)"|6 months|M/I|||Mg. of glucose/kg body w./mUxl ins.||Standard Error|Mean
1404743|NCT01223183|Primary|Mucociliary Clearance Rate After Hypertonic Saline Inhalation|The clearance rate of Tc-SC after the inhalation of hypertonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the hypertonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent cleared / 80 minutes||Standard Deviation|Mean
1404744|NCT01223183|Primary|Mucociliary Clearance Rate After Isotonic Saline Inhalation|The clearance rate of Tc-SC after the inhalation of isotonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the isotonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent cleared / 80 minutes||Standard Deviation|Mean
1404745|NCT01223183|Primary|Absorptive Clearance Rate After Hypertonic Saline Inhalation|The absorption rate of In-DTPA after the inhalation of hypertonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the hypertonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent cleared / 80 minutes||Standard Deviation|Mean
1404746|NCT01223183|Primary|Absorptive Clearance Rate After Isotonic Saline Inhalation|The absorption rate of Indium 111 diethylenetriaminepentaacetic acid (In-DTPA) in the airways after the inhalation of isotonic saline|80 minutes after radiopharmaceutical inhalation|"This group includes data from the isotonic saline inhalation day from both the isotonic then hypertonic and the hypertonic than isotonic groups who had sufficient imaging data to allow for full analysis."|||percent / 80 minutes||Standard Deviation|Mean
1404747|NCT01223027|Secondary|Pre-dose Concentration in Plasma in Dovitinib|Predose concentrations of dovitinib were summarized by visit using PAS. All concentration data was listed by patient and time point using FAS. Mean pre-dose concentrations along with standard deviation (SD) was plotted over time if appropriate.|Week 2 Day 5, Week 4 Day 5, Week 6 Day 5|Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one dose of dovitinib and had at least one evaluable post-Baseline dovitinib concentration measurement.|||ng/ml||Standard Deviation|Mean
1404758|NCT01222884|Secondary|Change in Hemoglobin Concentration||6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
1404748|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Quality of Life (QoL) Scale Scores of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1404749|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Definitive Deterioration of the Physical Functioning (PF) Scale of EORTC QLQ-C30 by at Least 10%|The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). Each of the multiitem scales includes a different set of items - no item occurs in more than one scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome.|from date of randomization|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1404750|NCT01223027|Secondary|Patient-reported Outcomes (PROs): Time to Deterioration of Functional Assessment of Cancer Therapy-Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) by at Least 2 Scores|The Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS) is a validated symptom scale used in studies of patients with kidney cancer. It includes 9-items that assess pain, bone pain, fatigue, lack of energy, shortness of breath, fevers, weight loss, coughing, and blood in urine and responses to each question are answered on a 5-point Likert-type scale ranging from 0 to 4 (e.g., 0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). FKSI-DRS scores range from 0 to 36, where higher scores correspond to better outcomes (eg, fewer symptoms).|from date of randomization, at least 2 score units|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1404751|NCT01223027|Secondary|Time to Definitive Worsening of Karnofsky Performance Status (KPS)|Time to definitive worsening of Karnofsky performance status (KPS) was defined as the time from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier. Definitive worsening was defined as a definitive decrease in performance status by at least one Karnofsky category (i.e. at least 10 points less) compared to Baseline. Worsening was considered definitive if no later increase above the defined threshold was observed within the course of the study. A single measure reporting a decrease in Karnofsky performance status was sufficient to consider it as definitive only if it was the last one available for this patient. Time to definitive worsening of KPS was analyzed at the time of the final analysis for PFS.|from date of randomization to the date of definitive worsening of KPS or to the date of death whichever occurred earlier|Full Analysis Set (FAS) consited of all randomized patients.|||Months||95% Confidence Interval|Median
1404752|NCT01223027|Secondary|Percentage of Participants With Overall Response Rate (ORR) by Central Radiology Review|Overall response rate (ORR) was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR). Best overall esponse (BOR) for each patient was determined from the sequence of overall (lesion) responses according to the following rules: CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. CR = at least two determinations of CR at least 4 weeks apart before progression where confirmation required or one determination of CR prior to progression where confirmation not required. SD = at least one SD assessment (or better) > 6 weeks after randomization (and not qualifying for CR or PR). PD = progression ≤ 17 weeks after randomization (and not qualifying for CR, PR or SD).|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.|||Percentage of Participants|||Number
1404753|NCT01223027|Secondary|Progression Free Survival (PFS) Per Investigator's Radiology Review|PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. The primary analysis for PFS (based on central review) was also to be repeated on FAS considering the Investigator assessments and using the same analytical conventions as the primary analysis.|Until disease progression or discontinuation of treatment due to unacceptable toxicity|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1404754|NCT01223027|Secondary|Overall Survival (OS)|Overall survival (OS) was the key secondary endpoint and was defined as the time from date of randomization to the date of death due to any cause. If a patient was not known to have died, survival was censored on the date of last contact.|until at least 386 deaths are documented in the clinical database.|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1404755|NCT01223027|Primary|Progression Free Survival (PFS) Per Independent Central Radiology Review|Assessed according to RECIST 1.1. PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. If a patient had not progressed or died, on the date of the analysis cut-off or when he/she received any further anti-neoplastic therapy, PFS was censored on the date of last tumor assessment before the cutoff date or the anti-neoplastic therapy date. The distribution of PFS was estimated using the Kaplan-Meier method. The median PFS along with 95% confidence intervals was presented by treatment group.|Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation)|Full Analysis Set (FAS) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
1404756|NCT01223001|Secondary|Hopkins Verbal Learning Test|To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.|9 months|||||||
1405497|NCT01216735|Primary|Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo|Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).|3 weeks treatment period of ICS or placebo||||% change||Standard Error|Mean
1404759|NCT01222884|Primary|Ability to Maintain Hemoglobin Level|The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis.|Baseline to 6 weeks|The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.|||percentage of participants|||Number
1404760|NCT01222871|Primary|Nasal Endoscopic Exam Findings .|nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.|2 weeks, 6 weeks, 12 weeks were not collected from any participant.|No participant started because study was terminated.||||||
1404761|NCT01222832|Primary|Rate of Infection|Number of participants without infections on post-op visits 90 days.|90 days||||Participants|||Count of Participants
1404762|NCT01222715|Other Pre-specified|Progression-free Survival|Progression-free survival data will be explored using Kaplan Meier analysis. Associations between this outcome and each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.|Up to 5 years|||||||
1404763|NCT01222715|Other Pre-specified|Levels of Biomarkers Related to the Effect of Temsirolimus on the Unfolded Protein Response||Up to 36 weeks|||||||
1404764|NCT01222715|Other Pre-specified|Clinical Response|The data reported in 2 groups will be summarized using numbers and percentages of patients in each stratum and at each time point (baseline, after course 2, at the time of best response and end of therapy or progressive disease, whichever comes first). A binomial generalized estimating equation (GEE) model will be fitted to the data. The variables in the model will be time, treatment group and a biomarker. The beta coefficient of the biomarker will quantify the strength of the association between clinical response and the biomarker, beyond the association of the outcome to the other variables.|Up to 5 years|||||||
1404765|NCT01222715|Other Pre-specified|Clinical Predictors, Including Histologic and Molecular Subtype, Age, Stage, and Site|These known risk factors will be compared to genomic features like gene and ribonucleic acid (RNA) expression values, as well as combinations of the two and splice variants of known genes, in order to identify those features most related to treatment resistance and poor outcome (overall survival and failure-free survival) using a Cox proportional hazards model of gene expression with cross validation.|Up to 5 years|||||||
1404766|NCT01222715|Other Pre-specified|Changes in Angiogenesis-associated Plasma Markers Between Patients by Treatment|First, the distributions of these markers will be compared at ‘end of 2 cycles’ between treatments using a 2-independent sample non-parametric test. The mean will also be modeled for each of these markers (or a transformation of the marker to near normality) as a function of time and treatment using GEEs which are designed to take into account the internal correlation of repeated measurements taken on the same subject. Associations between progression-free survival and changes in each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.|Baseline up to day 42|||||||
1404767|NCT01222715|Other Pre-specified|Biomarker Levels|Biomarker data will be summarized for each response category, at each time point using either means and standard deviations or medians and ranges.|Up to 36 weeks|||||||
1404768|NCT01222715|Secondary|Response Rate (CR + PR)|Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.|From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.|Only eligible participants with overall response evaluated were analyzed.|||Proportion of participants||95% Confidence Interval|Number
1404769|NCT01222715|Primary|Rate of Dose-Limiting Toxicities|The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays > 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis > 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP).|From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.|Only eligible participants were analyzed.|||Percentage of participants||95% Confidence Interval|Number
1404770|NCT01222715|Primary|Event Free Survival Probability|Probability of no relapse, secondary malignancy, or death after 1 year in the study.|1 year|Only eligible participants were analyzed.|||Probability||95% Confidence Interval|Number
1404771|NCT01222689|Secondary|Number of Patients With Dose Modifications and Reason for Dose Modification.|Tabulation of the reasons for dose modification with number of patients|Up to final day of study treatment|Numbers in tabulation total to more than 18 because patients often had 2 or more reasons that prompted dose reduction. For example: Nausea/Vomiting + diarrhea (3), fatigue + diarrhea (2), rash + hypertension (1), rash + diarrhea (1), fatigue + Nausea/Vomiting (1)|||participants|||Number
1404772|NCT01222689|Primary|Survival at 24 Weeks|Percent survival at 24 weeks (6 months)|24 weeks||||percentage of participants|||Number
1404773|NCT01222689|Other Pre-specified|Plasma Biomarkers Potentially Predictive of Dual MEK/EGFR Inhibition|"The association between candidate plasma biomarkers of interest, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response.~Specifically, correlation of the relative change in allelic frequency of mutations present in both pre-treatment and on-treatment blood samples versus percent change in CA19-9."|Up to 2 years|Patients who had non-germline mutations (circulating cell-free DNA) represented in both their pre-treatment blood and on-treatment blood samples.|||R^2|||Number
1404774|NCT01222689|Other Pre-specified|Circulating Tumor Cell (CTC) Analysis|The association between baseline CTC numbers, their longitudinal changes, and patient outcomes as measured by OS, PFS, and radiographic and biomarker response will be evaluated. The association between expression level of protein markers in CTC with biopsy samples using Pearson's correlation and by unsupervised hierarchical clustering of samples using Pearson correlation as the distance metric will be assessed. Association of longitudinal protein markers in CTC with patient OS will be evaluated using the joint models of longitudinal observations.|Up to 2 years|Data was not collected.||||||
1404775|NCT01222689|Other Pre-specified|Protein Expression Levels in Pretherapeutic Core Biopsies|Logistic regression models will be used to associate baseline protein markers and best objective response. Cox models will be used to associate baseline protein markers with overall and progression-free survival. Each selected protein markers will be evaluated individually and ranked by the corresponding p-values. Combinations of markers will also be explored.|Up to 2 years|Data was not collected.||||||
1404776|NCT01222689|Secondary|Incidence of Toxicities Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Tabulation of type of adverse events (AE) and the incidence of grade 3 and 4 for each AE|Up to 30 days after completion of study treatment||||events|||Number
1404777|NCT01222689|Secondary|Objective Radiographic Response by RECIST Criteria|"Patient's best overall response will be tabulated by level; proportions of complete response (CR) and of CR+partial response will be calculated along with 95% confidence intervals.~Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR, >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR."|Up to 2 years|There were no complete or patial responses by RECIST (stable disease, partial response, or complete response) amongst the 46 participants|||participants|||Number
1404778|NCT01222689|Secondary|CA19-9 Biomarker Response (Defined as a 50% Decline in Serum CA19-9 Level From Baseline in Patients With > 2 x ULN CA19-9 Measurement)|The proportion of patients with CA19-9 response.|Up to 2 years|Patients with baseline levels > 2 x ULN CA19-9 measurement|||percentage of participants|||Number
1404779|NCT01222689|Secondary|Progression-free Survival (PFS)|"Calculated according to the method of Kaplan and Meier. Actual and estimated probability of being alive and progression-free, along with a 95% confidence interval, will be calculated.~Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(Macdonald et al.):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used. Progressive Disease is defined as a 20% or higher increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions)."|From first dose of study treatment to the date of objective progression, or death due to cancer or unknown cause, or to the date of withdrawal from the trial from unknown reasons, assessed up to 2 years||||months||95% Confidence Interval|Median
1404780|NCT01222689|Primary|Overall Survival (OS)|Survival will be calculated according to the method of Kaplan and Meier. Both actual and estimated probability of being alive (along with a 95% confidence interval) at 24 weeks (6 months) and for any multiple of 6 months will be calculated for which the number of uncensored subjects is not smaller than 10.|Up to 2 years||||months||95% Confidence Interval|Median
1404781|NCT01222585|Primary|Volume of Distribution|Volume of Distribution (L/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.|||L/kg||Full Range|Median
1404782|NCT01222585|Primary|Clearance|Clearance (L/h/kg)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the PK parameter.|||L/h/kg||Full Range|Median
1404783|NCT01222585|Primary|Multiple Dose Minimum Concentration|Multiple Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.|||mg/L||Full Range|Median
1404784|NCT01222585|Primary|Multiple Dose Maximum Concentration|Multiple Dose Maximum Concentration (mg/L)|2-5 days of study drug administration|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate the multiple dose PK parameter.|||mg/L||Full Range|Median
1404785|NCT01222585|Primary|Loading Dose Minimum Concentration|Loading Dose Minimum Concentration (mg/L)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.|||mg/L||Full Range|Median
1404786|NCT01222585|Primary|Loading Dose Maximum Concentration|Loading Dose Maximum concentration (Cmax)|2-5 days of study drug administration|The sample size contains the number of subjects that had the sample of interest collected.|||mg/L||Full Range|Median
1404787|NCT01222585|Primary|Area Under the Curve at Steady State|Area under the curve at steady state (AUCss)|pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose|The PK analysis was conducted using samples from 23 subjects. One subject died soon after the loading dose and was excluded from the analysis. Two subjects had no multiple dose samples. Thus data from 20 subjects were used to estimate this PK parameter.|||mg*hr/L||Full Range|Median
1404798|NCT01222533|Other Pre-specified|Maximum Heart Rate (HR)|"Maximum HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded).|||bpm||Standard Deviation|Mean
1405498|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|26 weeks|||||||
1405499|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|16 weeks|||||||
1404788|NCT01222572|Primary|Maximum Tolerated Dose (MTD)|"The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.~DLTs were defined as follows (CTCAE v4.0):~Grade 2 non-hematologic toxicities: Myelitis; Esophageal fistula, perforation, hemorrhage~Grade 3 non-hematologic toxicities considered to be a direct result of therapy:~Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 4 non-hematologic toxicities: Radiation pneumonitis; Pericarditis, pericardial effusion, pericardial tamponade; Esophagitis (not due to mediastinal irradiation unrelated to the stereotactic boost), esophageal necrosis, stenosis, ulcer; Dyspnea; Myelitis Grade 5 non-hematologic toxicity: Any"|7-week chemoradiotherapy period and the subsequent 8-week recovery period|All treated participants who received at least one dose of the study drug and were evaluable for DLT.|||participants with DLT|||Number
1404789|NCT01222533|Other Pre-specified|VPB Singles|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404790|NCT01222533|Other Pre-specified|VPB Pairs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404791|NCT01222533|Other Pre-specified|VPB Runs|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404792|NCT01222533|Other Pre-specified|VPB Total|"The outcome measure describes the number of patients with a Ventricular Premature Beat (VPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404793|NCT01222533|Other Pre-specified|SVPB Singles|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) single evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404794|NCT01222533|Other Pre-specified|SVPB Pairs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) pair evaluated over the entire 6.5 h Holter monitoring period. Pairs were defined as 2 consecutive premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404795|NCT01222533|Other Pre-specified|SVPB Runs|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) run evaluated over the entire 6.5 h Holter monitoring period. Runs were defined as at least 3 premature beats in a row. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404796|NCT01222533|Other Pre-specified|SVPB Total|"The outcome measure describes the number of patients with a Supraventricular Premature Beat (SVPB) event evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||participants|||Number
1404797|NCT01222533|Other Pre-specified|Mean Heart Rate (HR)|"Mean HR evaluated over the entire 6.5 h Holter monitoring period. The arrhythmia variables were pre-specified for day 29 and analysed post-hoc for day 26. The lines Day 29 1st h and Day 26 1st h are related to the interval 0 h to 1 h, i.e. the first hour after dosing."|6.5 hours (including pre dose)|ECGFAS - including all patients in the treated set for whom continuous 12 lead ECGs (Holter monitoring) were recorded on at least one occasion (pacemaker patients were excluded)|||bpm||Standard Deviation|Mean
1404846|NCT01222104|Secondary|Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).|30 days||||% of procedures with MVCs|Participants||Number
1405500|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|14 weeks|||||||
1404799|NCT01222533|Secondary|Minimum Plasma Concentration at Steady-state (Cmin,ss)|Cmin,ss is the minimum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1404800|NCT01222533|Secondary|Renal Clearance at Steady-state (CL R,0-6h,ss)|Renal clearance of the drug over the time interval 0 to 6 hours at steady-state. CL R,0-6h,ss was calculated as the quotient of Ae0-6h,ss and AUC0-6h,ss.|Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing.|PK Set. All patients with analysable data.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1404801|NCT01222533|Secondary|Pre-dose Plasma Concentration at Steady-state (Cpre,ss)|Cpre,ss is the measured concentration of tiotropium in plasma before dosing at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline)|PK Set. All patients with analysable data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1404802|NCT01222533|Secondary|Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)|Total quantity of the analyte that is excreted in urine over the time interval 0 to 6 hours at steady state.|Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing.|PK Set. All patients with analysable data.|||ng||Geometric Coefficient of Variation|Geometric Mean
1404803|NCT01222533|Secondary|Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)|Tmax,ss is the time from dosing to the maximum concentration of tiotropium in plasma-venous blood at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.|||hours||Full Range|Median
1404804|NCT01222533|Secondary|Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)|AUC0-1h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 1 hour post-dose at steady-state. AUC0-1h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. All patients with analysable data.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1404805|NCT01222533|Secondary|FVC at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
1404806|NCT01222533|Secondary|FEV1 at Each Planned Time at the End of Each Treatment Period|Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.|4 weeks|FAS with imputed data.|||Liter||Standard Error|Mean
1404807|NCT01222533|Secondary|FVC AUC0-3h at the End of Each Treatment Period|FVC AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
1404808|NCT01222533|Secondary|FVC AUC0-6h at the End of Each Treatment Period|FVC AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
1404809|NCT01222533|Secondary|Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period|Defined as the pre-dose FVC measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data. One patient with missing FVC data in Placebo and Tio R2.5 period.|||Liter||Standard Error|Mean
1404810|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period|FEV1 AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.|||Liter||Standard Error|Mean
1404811|NCT01222533|Secondary|FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period|FEV1 AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|FAS with imputed data.|||Liter||Standard Error|Mean
1404812|NCT01222533|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period|Defined as FEV1 measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.|4 weeks|Full analysis set (FAS) with imputed data. FAS includes all patients in the treated set who have analysable data for at least one efficacy endpoint during the relevant crossover period.|||Liter||Standard Error|Mean
1404813|NCT01222533|Primary|Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)|AUC0-6h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours post-dose at steady-state. AUC0-6h,ss was calculated using the linear up/log down algorithm.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|PK Set. No PK data for Placebo. The low number of non-missing AUC0-6h,ss results for the Tio R 1.25 and Tio R 2.5 cohorts is due to the exclusion of results below the limit of quantification.|||pg*h/ml||Geometric Coefficient of Variation|Geometric Mean
1404847|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device|Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.|30 days||||% of procedures achieving hemostasis|Participants||Number
1405501|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|8 weeks|||||||
1404814|NCT01222533|Primary|Maximum Plasma Concentration at Steady-state (Cmax,ss)|Cmax,ss is the maximum measured concentration of tiotropium in plasma at steady-state.|Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.|Pharmacokinetic (PK) Set. This analysis set includes all patients in the treated set who had at least one blood sample drawn or one urine sample collected for PK analysis. Patients with an important protocol violation relevant to the PK population were excluded. No PK data for placebo. All patients with analysable data.|||pg/ml||Geometric Coefficient of Variation|Geometric Mean
1404815|NCT01222520|Secondary|Seated Blood Pressure (BP) Normalisation at Trough|Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Participants|||Number
1404816|NCT01222520|Secondary|Seated SBP Response Rate at Trough|SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Percentage of participants|||Number
1404817|NCT01222520|Secondary|Seated DBP Response Rate at Trough|DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Percentage of participants|||Number
1404818|NCT01222520|Secondary|Seated SBP Control Rate at Trough|SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|Patients included in FAS and with seated SBP ≥140 mmHg at reference baseline|||Percentage of participants|||Number
1404819|NCT01222520|Secondary|Seated DBP Control Rate at Trough|DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing|8 weeks|FAS|||Percentage of participants|||Number
1404820|NCT01222520|Secondary|Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
1404821|NCT01222520|Primary|Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough|Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing|Baseline, 8 weeks|Full analysis set (FAS)|||mmHg||Standard Error|Least Squares Mean
1404822|NCT01222507|Primary|Brain Speed Test|This test involves the presentation of two consecutive high or low-frequency sound sweeps that requires the participant to correctly identify the order of presentation of the sound sweeps. Correct identification of the sound sweeps requires intact brain processing speed and attention. Scores are presented relative to age-matched controls used in validating the test. The normative data for the controls for this test will be provided by Posit Science® to the PI.|Initial study visit|The number of subjects who completed the study according to protocol.|||units on a scale||95% Confidence Interval|Median
1404823|NCT01222416|Secondary|Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.||48 months|There were insufficient number of patients who had both MRI and PET performed to allow for meaningful statistical comparisons.||||||
1404824|NCT01222416|Primary|The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)|The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the|up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)|19 Patients had the scanned data at two time points: prior treatment and at the end of treatment.|||microcuries/g/(millicuries/kg)||95% Confidence Interval|Median
1404825|NCT01222403|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.|The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.|||Number of Subjects|||Number
1404826|NCT01222403|Primary|Number of Subjects Reporting Unsolicited AEs After Vaccination.|The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 28 post vaccination|Analysis was done on safety population.|||Number of Subjects|||Number
1404827|NCT01222403|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.|The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.|Day 1 through Day 4 after vaccination|Analysis was done on safety population ie. all subjects in the exposed set who provided postvaccination safety data.|||Number of Subjects|||Number
1404848|NCT01222104|Secondary|Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device|Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device|30 days||||% of procedures using closure device|Participants||Number
1404849|NCT01222104|Secondary|Rate of Minor Vascular Complications by Guided Access Mode.|The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.|30 days||||% of procedures with minor vasc comp.|Participants||Number
1404828|NCT01222390|Primary|Breast Projection|The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).|1.5 years||||percentage loss of projection|Participants|Standard Deviation|Mean
1404829|NCT01222390|Secondary|Location of Volume Change|3-D photos will be taken to assess the location of volume and contour changes in the breast.|1.5 years|||||||
1404830|NCT01222390|Secondary|Emotional Outcomes|Emotional outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years|||||||
1404831|NCT01222390|Secondary|Complication Rate|Complications may include hematoma, seroma, infection, implant migration, inflammation or explantation.|1.5 years|||||||
1404832|NCT01222390|Secondary|Aesthetic Outcomes|Aesthetic outcomes will be compared between the two groups using respective questionnaires. Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.|1.5 years|||||||
1404833|NCT01222286|Secondary|Secondary Anti-tumor Activity|"any change of M-protein in serum occurring during the study (>25 percentage increase in level of serum M-protein)~progression to active Multiple Myeloma~Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder :~Development of new soft tissue plasmacytomas or bone lesions~Hypercalcemia (> 11mg/100ml)~Decrease in hemoglobin of > 2g/100ml~Rise in serum creatinine by 2 mg/100ml or more"|from start to end of study (14 months)||||Participant|||Number
1404834|NCT01222286|Secondary|Pharmacodynamics of IPH2101|biological activity of IPH2101 on KIR occupancy at End of Treatment|from start to end of study (14 months)|all subjects who received at least 1 dose of IPH2101|||% of occupancy of killer like receptor||Full Range|Mean
1404835|NCT01222286|Secondary|Safety Assessment|adverse events, physical examination and biological changes during the whole clinical trial.|Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months|The safety population included all subjects who received at least 1 dose of IPH2101|||Patients with any AE|||Number
1404836|NCT01222286|Primary|Rate of Patients Achieving an Objective Response|The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.|from start to end of study (14 months)|The ITT population included all randomized subjects.|||participants|||Number
1404837|NCT01222273|Secondary|Change in Patient Aspergillus Specific IgE Levels|To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce aspergillus specific IgE levels by the end of the 24-week period|6 months||||kUA/I||Standard Deviation|Mean
1404838|NCT01222273|Secondary|Change in Patient Total IgE Levels|To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce total IgE levels by the end of the 24-week period|6 months||||IU/mL||Standard Deviation|Mean
1404839|NCT01222273|Primary|Number of Participants With Aspergillus Induced IL-13 Responses in CD4+ T-cells|To test the hypothesis that supplementation with Vitamin D in CF patients with ABPA will reduce Aspergillus induced IL-13 responses in peripheral CD4+ T-cells. Response confirmed for each individual patient and recorded as number of participants with response.|6 months||||Participants|||Count of Participants
1404840|NCT01222234|Primary|Change in 24,25(OH)2D Levels in CKD vs. Non-CKD Subjects Receiving Cholecalciferol||8 weeks of therapy|The primary comparison for this outcome of interest was between subjects taking cholecalciferol, so the calcitriol group (group 2) was excluded from the analysis. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.|||ng/ml||Standard Deviation|Mean
1404841|NCT01222234|Primary|Monocyte Protein Expression|Flow cytometry analysis of monocyte CD14, ACE, VDR, and Mac-1 expression|8 weeks of therapy|The primary comparison for this outcome was between only CKD groups (groups 1 and 2); therefore data from the non-CKD group (group 3) was not analyzed for this outcome. Only 15 patients per group had data analyzed for this outcome of interest; thus, the number analyzed per group differs from the enrolled numbers.|||relative fluorescence units||Standard Deviation|Mean
1404842|NCT01222195|Primary|Number of Patients With a Transfusion Independence Response|Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.|Over six 28-day cycles (approximately 168 days)|Analysis was per protocol.|||participants|||Number
1404843|NCT01222117|Secondary|The Incidence of Major and Minor Bleeding Events, Deaths, Adverse Events, Serious Adverse Events, and Abnormal Laboratory Values as a Measure of Safety and Tolerability.|The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.|30 days|Subjects were excluded from the safety population if they did not receive any dose of Plasmin (groups I and J) or placebo (group F)|||percentage of participants|||Number
1404844|NCT01222117|Primary|The Proportion of Subjects With >50% Thrombolysis|The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography.|5 hours (Treatment Groups A, B, C, G, I, M) or 2 hours (Treatment Groups D, H, J)|In groups A-D, G and H, 8 subjects were excluded (EOT arteriogram missing or not read, did not receive >=90% of dose). In groups I and J, 11 subjects were excluded (BOC not inserted/appropriately inflated, missing an arteriogram). In group F, 1 subject was not dosed and 4 subjects were excluded (did not receive >=90% of dose).|||percentage of participants|||Number
1404845|NCT01222104|Secondary|Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD)|Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.|30 days||||% of procedures with minor vasc comp.|Participants||Number
1404852|NCT01222104|Secondary|Impact of Guided Access on Use of Closure Device.|The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.|30 days|Percentage of procedures with devices deployed|||% of procedures using a closure device|Participants||Number
1404853|NCT01222104|Secondary|Rate of Minor Vascular Complications|"The following are defined as a minor vascular complication:~Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;~Ipsilateral hematoma >10 cm;~Ipsilateral pseudoaneurysm without intervention;~Ipsilateral arteriovenous fistula;~Ipsilateral deep vein thrombosis;~Local access site infection without prolonged hospitalization"|30 days||||% of procedures with minor vasc comp.|Participants||Number
1404854|NCT01222104|Secondary|Time to Hemostasis|Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved >5 minutes and/or with additional hemostasis methods required.|Procedure||||% of procedures|Participants||Number
1404855|NCT01222104|Primary|Rate of Major Vascular Complications|"Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.~The following are defined as a major vascular complication:~Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;~Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;~Access site related bleeding requiring transfusion;~New ipsilateral lower extremity ischemia requiring surgical intervention;~Retroperitoneal bleeding;~Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;~Access related complication that results in extended hospital stay;~Death"|30 days|5 subjects underwent vascular closure with Angio-Seal on right and left sides.|||Percentage of Procedures|Participants||Number
1404856|NCT01222091|Secondary|Objective Opioid Withdrawal Scale (OOWS)|OOWS: Is a 13-item instrument of documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score = 13, minimum score = 0. Lower scores correspond to fewer symptoms.|Pretreatment [90 min prior to 60-min REM infusion]; 30 min prior to 60-min REM infusion; 15 and 40 min after start of 60-min REM infusion; 5, 15, and 75 minutes after finish of 60-min REM infusion)||||units on a scale||Standard Deviation|Mean
1404857|NCT01222091|Primary|Percent Change From Baseline in Size (Area) of Secondary Hyperalgesia After Cessation of Remifentanil Infusion, a Measure of Opioid-induced Hyperalgesia (OIH).|A slightly modified version of a previously described model of secondary hyperalgesia was used. Two copper wires contained in a microdialysis catheter were inserted in parallel over a length of 5 mm into the dermis of the right volar forearm. The wires were connected to a constant current stimulator controlled by a pulse generator to deliver rectangular and monophasic pulses with a duration of 0.5 mg at 2 Hz. Over a period of 15 min, the current was increased by targeting a pain rating of 5 on an 11-point numeric rating scale (0 = no pain and 10 = maximum tolerable pain) until the hyperalgesic area surrounding the stimulation site was fully established. Once the area was established, the current was held constant. Percent change from baseline in size (area) of secondary hyperalgesia after cessation of remifentanil infusion was calculated per group.|Baseline; 15 min post remifentanil (REM) infusion; 60 min post REM infusion||||percentage of change|||Number
1404858|NCT01222078|Secondary|Terminal Phase Half-life (Thalf) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||hours||Full Range|Median
1404859|NCT01222078|Secondary|Time of Last Observed Quantifiable Concentration (Tlast) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||hours||Full Range|Median
1404860|NCT01222078|Secondary|Area Under the Serum Concentration-time Curve [AUC(0-tlast)] of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||Hours times nanograms per milliliter||Standard Deviation|Mean
1404861|NCT01222078|Secondary|Time to Cmax (Tmax) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||hours||Full Range|Median
1404862|NCT01222078|Secondary|Maximum Observed Serum Concentration (Cmax) of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||ng/mL||Standard Deviation|Mean
1404863|NCT01222078|Secondary|Mean Individual Serum Concentrations of Otelixizumab|Because of the early termination of the study the data was not analyzed.|Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course|Safety Population|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1404864|NCT01222078|Secondary|Mean Saturation of CD3 Antigen on Peripheral Blood T Cells|Assessment of CD3 antigen was planned to be done on Day 1, 4 and 8 of first treatment course. The data was planned to be presented with unit Molecules of Equivalent Soluble Fluorochrome (MESF). Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||MESF||Standard Deviation|Mean
1404865|NCT01222078|Secondary|Mean Circulating CD4+ and CD8+ Subset Counts|Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||Percent total lymphocytes||Standard Deviation|Mean
1404866|NCT01222078|Secondary|Mean Circulating Peripheral T Lymphocytes Count|Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Day 1, 4 and 8 of each treatment course|Safety Population|||GI/L||Standard Deviation|Mean
1404867|NCT01222078|Primary|Proportion of Anti-otelixizumab Neutralizing Antibodies|Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.|Up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404868|NCT01222078|Primary|Mean Serum Levels of Anti-otelixizumab Binding Antibodies|Antibodies to otelixizumab were planned to be measured at Baseline and at specified post-Baseline visits using a validated immunoassay. If a positive result was detected, the samples were analyzed further in a neutralizing antibody assay to determine if the antibodies were neutralizing. The 12 and 24 month samples were only be taken if a participant had a positive result for antibodies at the last tested time point (Month 9) or if the Month 9 test results were not available.|Up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404869|NCT01222078|Primary|Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts|Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||Percent total lymphocytes||Standard Deviation|Mean
1404870|NCT01222078|Primary|Mean Change in Circulating Peripheral T Lymphocytes|Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||GI/L||Standard Deviation|Mean
1404871|NCT01222078|Primary|Mean Change in CD4+ and CD8+ T-cell Counts|CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.|Days 1, 4 and 8 of each treatment course|Safety Population|||Percent total lymphocytes||Standard Deviation|Mean
1404872|NCT01222078|Primary|Mean Change in Total Lymphocyte Count|Total lymphocyte count was planned to be analyzed up to Month 24.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study this endpoint was not collected.||||||
1404873|NCT01222078|Primary|Mean Epstein-Barr Virus (EBV) Viral Load|Levels of EBV were assessed periodically using Quantitative Polymerase Chain Reaction. If a participant had an EBV viral load of >=10,000 copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs) at any visit, the test was repeated as soon as possible to confirm this result. If the result was confirmed, the test was repeated weekly for 2 weeks or until the count decreases to < 10,000 copies per 10^6 PBMCs, whichever was longer. The EBV Load remained zero throughout the study. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination. The viral load was to measure using unit copies per 10^6 Peripheral Blood Mononuclear Cells (PBMCs)|Up to Month 24|Safety Population|||Copies per 10^6 PBMCs||Standard Deviation|Mean
1404874|NCT01222078|Primary|Mean Change From Baseline in Red Blood Cell Count|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404875|NCT01222078|Primary|Mean Change From Baseline in Hemoglobin Value|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404876|NCT01222078|Primary|Mean Change From Baseline in Glycosylated Hemoglobin Value|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404877|NCT01222078|Primary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count and White Blood Cell Count|Hematology parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404878|NCT01222078|Primary|Mean Change From Baseline in Value of Estradiol|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404879|NCT01222078|Primary|Mean Change From Baseline in Value of Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404880|NCT01222078|Primary|Mean Change From Baseline in Value of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404881|NCT01222078|Primary|Mean Change From Baseline in Value of Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Follicle Stimulating Hormone, Gamma Glutamyl Tranferase and Lactate Dehydrogenase|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404882|NCT01222078|Primary|Mean Change From Baseline in Value of Albumin and Total Protein|Clinical chemistry parameters were planned to be analyzed from Baseline to Month 24. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404883|NCT01222078|Primary|Number of Participants With Values Outside the Normal Range for Vitals|Vital included assessment of SBP, DBP, respiration rate, heart rate and temperature were assessed at sitting position. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination.|Up to Month 24|Safety Population|||Participants|||Number
1404884|NCT01222078|Primary|Mean Change From Baseline in Heart Rate|Heart rate was recorded at sitting position at Baseline and post-treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404885|NCT01222078|Primary|Mean Change From Baseline in Temperature|Temperature was recorded at sitting position at Baseline and post treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404886|NCT01222078|Primary|Mean Change From Baseline in Respiration Rate|Respiration rate was assessed at sitting position at Baseline and post-treatment. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404887|NCT01222078|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was assessed at sitting position at Baseline and 1 to 7 hours of post-infusion of first treatment period. Day 1 value was considered to be Baseline value. Change from Baseline was planned to be calculated as any post-Baseline value minus Baseline value.|Baseline and up to Month 24|Safety Population. Because of the early termination of the study the data was not collected.||||||
1404888|NCT01222078|Primary|Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Study was early terminated and participant withdrew on study Day 164.|Up to Month 24|Safety Population consisted of participants who had received at least one dose of infusion.|||Participants|||Number
1404889|NCT01221948|Secondary|Percentage of Participants With Improved, No Change or Worsened Global Impression of Change (GIC) as Compared to Baseline, Evaluated by the Neurologist.|Global Impression of Change (GIC) is a comparison to baseline and will be evaluated by rating the global impression of change using a seven-point scale: (“very much improved” to “marked worsening”). This assessment was completed by the neurologist.|52 weeks post first lead implantation||||percentage of participants|||Number
1404890|NCT01221948|Primary|Mean Change in UPDRS III Score From Baseline in the Meds Off Condition (no Medications) to 26 Weeks Post First Lead Implantation in the Stim on/Meds Off Condition (Stimulation on and no Medications).|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.~Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|26 weeks post first lead implantation||||units on a scale||Standard Deviation|Mean
1404891|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Modified Schwab and England (SE) Scores From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on|The purpose of the Schwab and England (SE) (13) single-item scale is to quantify a PD patients’ ability to perform activities of daily living. The single item is based on a percentage rating with scores in 10% increments. Scores range from 0% (completely bed-ridden) to 100% (completely independent).|12, 26 and 52 weeks post first lead implantation||||percentage change||Standard Deviation|Mean
1404892|NCT01221948|Secondary|Mean Percent Change in Quality of Life Scale Scores: Parkinson’s Disease Questionnaire (PDQ-39) From Baseline Meds on to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds on.|"The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. The questions measure the impact on health-related quality of life along 8 dimensions:~mobility~activities of daily living~emotional well-being~stigma~social support~cognitions~communication~bodily discomfort. Dimension scores range from 0 to 100, with 0 representing perfect health for the measure and 100 representing worst health for the measure."|12, 26 and 52 weeks post first lead implantation||||percentage change||Standard Deviation|Mean
1404893|NCT01221948|Secondary|Mean Change in the Number of Waking Hours Per Day With Good Symptom Control and no Troublesome Dyskinesia From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation.|Subjects will complete a 3-day motor diary prior to study visits. At one-hour increments (during waking hours), patients will record “on”, “on with troublesome dyskinesia”, “off”, and “asleep” times for three consecutive days.|12, 26 and 52 weeks post first lead implantation||||hours/day||Standard Deviation|Mean
1404894|NCT01221948|Secondary|Mean Change in Antiparkinsonian Medication Use in Mgs (Levodopa or Equivalents) From Baseline to 12, 26 and 52 Weeks Post First Lead Implantation|All parkinsonian medications will be converted to Levodopa dose equivalents (LED) and baseline dose will be compared with dose taken at 12, 26 and 52 weeks post implantation|12, 26 and 52 weeks post first lead implantation|40 completed Baseline, 35 completed Week12, 39 completed Week 26 and 38 completed Week 52|||mg||Standard Deviation|Mean
1404895|NCT01221948|Secondary|Mean Change in UPDRS II Score From Baseline Meds Off to 12, 26 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part II (UPDRS II) is a sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate Activities of Daily Living. This section contains 13 items.~Each item is scored on a scale from 0 (normal) to 4 (disabled), with the total score for the 13 items ranging from 0 to 52."|12, 26 and 52 weeks post first lead implantation||||units on a scale||Standard Deviation|Mean
1404896|NCT01221948|Secondary|Mean Change in UPDRS III Score From Baseline Meds Off to 12 and 52 Weeks Post First Lead Implantation Stim on/Meds Off.|"Unified Parkinson's Disease Rating Scale Part III (UPDRS III) is the motor sub-section of the Unified Parkinson's Disease Rating scale designed to evaluate overall motor disability, including the classic symptoms of Parkinson's Disease. This section has 14 items.~Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108 with lower scores representing better results."|12 and 52 weeks post first lead implantation||||units on a scale||Standard Deviation|Mean
1404897|NCT01221753|Secondary|4-y Overall Survival Rate|4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.|Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).|The analysis dataset is comprised of all treated patients. Since all patients have not been followed for survival for 5 years the 4-year rate is provided. All data provided was based on chart review and not from case report forms.|||percentage of participants|||Number
1404898|NCT01221753|Primary|2-Year Local-Regional Control Rate|2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.|The study was terminated early due to weak accrual. Clinical outcome data were not accessible for results reporting due to the designation of study completed at the institution.||||||
1404899|NCT01221727|Secondary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
1404900|NCT01221727|Secondary|Summary of Percent Change From Baseline to Day 16 for Serum C-Telopeptide Concentration|This table summarizes percent change from baseline to day 16 for serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.|||percentage|percentage|Inter-Quartile Range|Median
1404901|NCT01221727|Primary|Ratio of PK Cmax Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
1404902|NCT01221727|Secondary|Summary of Serum C-Telopeptide Concentration|This table summarizes serum C-Telopeptide (sCTX) concentration raw values for Midazolam with Denosumab group.|Baseline (day 2 pre-dose) to day 16|Serum CTX will be collected for Midazolam with Denosumab group only. The PD analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum CTX concentrations are determinable on when assessed.|||ng/mL|concentration|Inter-Quartile Range|Median
1404903|NCT01221727|Secondary|Summary of Serum Denosumab Concentration|This table summarizes serum Denosumab for Midazolam with Denosumab group. The Lower Limit Of Quantification (LLOQ) is 20 ng/mL. On Day 2 (pre-dose), the true value is below LLOQ, and is treated as 0 in the analysis.|Baseline (day 2 pre-dose) to day 16|Serum Denosumab will be collected for subjects in Midazolam with Denosumab group only. The analysis set will contain subjects in Midazolam with Denosumab group who received denosumab administration and for whom serum Denosumab concentrations are determinable when assessed.|||ng/mL|concentration|Standard Deviation|Median
1404904|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for PK Cmax Parameter for Midazolam Only Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng/mL|concentration|Standard Deviation|Mean
1404905|NCT01221727|Secondary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam Only Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng*hr/mL|area|Standard Deviation|Mean
1404939|NCT01221441|Primary|Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year|Reduction in pain as measured by a 100 mm visual analog scale (0= no pain; 100 = extreme pain) from Baseline to 1 Year. Linear mixed model used for analysis.|1 Year|Patients with available baseline and 1 year VAS score|||units on a scale||95% Confidence Interval|Least Squares Mean
1404906|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for PK Maximum Observed Plasma Concentration (Cmax) Parameter for Midazolam With Denosumab Group|Cmax Subject denotes the inter-subject variability, while Cmax Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng/mL|concentration|Standard Deviation|Mean
1404907|NCT01221727|Primary|Estimates of Inter- and Intra-subject Variability for the PK AUC Parameters for Midazolam With Denosumab Group|AUC Subject denotes the inter-subject variability, while AUC Residual denotes the intra-subject variability|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||ng*hr/mL|area|Standard Deviation|Mean
1404908|NCT01221727|Secondary|Ratio of PK AUC Parameter Estimates Between Day 16 (Midazolam Only) and Day 1(Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam only group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
1404909|NCT01221727|Primary|Ratio of Pharmcokinetic (PK) Area Under the Concentration Time Curve (AUC) Parameter Estimates Between Day 16 (Midazolam With the Presence of Denosumab) and Day 1 (Midazolam Only)|The ratio and confidence interval are calculated based on natural log scale data and converted back to the original scale.|From day 1 pre-dose to 24 hours post-dose and from day 16 pre-dose to 24 hours post-dose|The analysis set will contain all subjects from Midazolam with Denosumab group for whom the primary endpoint PK parameters (AUC(0-t), AUC(0-inf) and Cmax) can be estimated for both treatment periods.|||unitless|unitless|90% Confidence Interval|Least Squares Mean
1404910|NCT01221623|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 52|Composite responder analysis is based on the ITT population.|||participants|||Number
1404911|NCT01221623|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
1404912|NCT01221623|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy is based on the mITT population.|||centimeters||Standard Deviation|Mean
1404913|NCT01221623|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404914|NCT01221623|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404915|NCT01221623|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404916|NCT01221623|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicated a responder.|Week 52|Efficacy is based on the mITT population.|||participants|||Number
1404917|NCT01221623|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404918|NCT01221623|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat (mITT) population.|||percentage of curvature change||Standard Deviation|Mean
1404919|NCT01221597|Secondary|Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score|A responder was defined as a subject who satisfied the following 2 criteria at that visit: a) percent reduction from baseline in curvature deformity was ≥20% and b) reduction from baseline in PDQ Peyronie’s disease bother score was ≥1, or had a change from reporting no sexual activity at screening to reporting sexual activity.|Week 52|Efficacy analysis is based on the mITT population.|||Number of participants|||Number
1404938|NCT01221441|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years|Symptoms, pain and functionality of the knee joint as determined by Total Score of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (Range 0-100 with higher scores indicating healthier outcomes). Linear mixed model used for analysis.|2 Years||||scores on a scale||95% Confidence Interval|Least Squares Mean
1404920|NCT01221597|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population. This population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
1404921|NCT01221597|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||centimeters||Standard Deviation|Mean
1404922|NCT01221597|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404923|NCT01221597|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404924|NCT01221597|Secondary|Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy analysis is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404925|NCT01221597|Secondary|A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease|A responder was defined as a subject who recorded his Peyronie’s disease had either improved in a small but important way, moderately improved, or much improved in overall global assessment question.|Week 52|Efficacy analysis was based on the mITT population.|||Number of particpants|||Number
1404926|NCT01221597|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 52|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
1404927|NCT01221597|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 52|Efficacy is based on the modified intent-to-treat population (mITT).|||percentage of curvature change||Standard Deviation|Mean
1404928|NCT01221441|Secondary|Change in SF-36 General Health Assessment Questionnaire (Overall Score) From Baseline to 2 Years|Overall assessment of general health as determined by scoring use an SF-36 Questionnaire (Range 0-100 with higher scores better - indicating less disability)|2 Years|Patients with completed SF-36 questionnaire at 104 weeks|||scores on a scale||95% Confidence Interval|Least Squares Mean
1404929|NCT01221441|Secondary|Number of Participants With Adverse Events Due to Clinically Significant Changes in Hematology and Urinalysis Tests|The number of participants with changes in clinical hematology, chemistry, and urinalysis test results through 2 years that were considered Adverse Events|2 Years|All patients|||participants|||Number
1404930|NCT01221441|Secondary|The Incidence and Severity of Adverse Events in Treated Patients|The incidence and severity of adverse events assessed through 104 weeks (2 years) after dose administration|2 Years|All patients receiving treatment with either active or placebo|||participants|||Number
1404931|NCT01221441|Secondary|The Number of Patients Experiencing Injection Site Reactions Related to Treatment|The number of patients with observations of the administration site deemed related to treatment with either active or placebo, including arthralgia, swelling, irritation, pain, stiffness or abnormalities|2 Years|All participants receiving placebo or active treatment|||participants|||Number
1404932|NCT01221441|Secondary|The Incidence of Total Knee Arthroplasty|Quantification of the incidence of total knee arthroplasty of the treated knee subsequent to treatment with TissueGene-C|2 Years|All patients that participated in the study|||participants|||Number
1404933|NCT01221441|Secondary|Change From Baseline in Knee Function as Determined by the Lower Extremity Functional Scale at 2 Years|Assessment of knee function as determined by the Lower Extremity Functional Scale (LEFS); change from baseline to 2 years (Range 0-80 with higher scores signifying lower difficulty in performing knee functions)|2 Years|Patients that completed 2-year follow-up|||scores on a scale||95% Confidence Interval|Least Squares Mean
1404934|NCT01221441|Secondary|Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia|The number of participants that had a change in pain severity as measured by the incidence and dose of analgesic medications|2 Years|Patients taking at least one analgesia medication|||participants|||Number
1404935|NCT01221441|Secondary|Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire|Change in pain severity (on a scale from 1 to 4) from baseline to 2 years as measured by a questionnaire (lower scores better)|2 Years|Patients that completed 2 year follow-up|||scores on a scale||Standard Deviation|Mean
1404936|NCT01221441|Secondary|Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year|Comparison of pre-procedure 3T MRI scans to those obtained at months 12 following dose administration by an independent radiographic reviewer. Evaluations will be scored using Whole Organ Magnetic Resonance imaging Score (WORMS) Cartilage Morphology Subscore (Range 0-6, with higher scores being worse)|1 Year|Patients with available baseline and 1-year MRIs|||scores on a scale||95% Confidence Interval|Least Squares Mean
1404937|NCT01221441|Secondary|Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years|Measurement to assess outcomes of various chondral disorders of the knee determined by the Lysholm Knee Scale (Range 0-100 with higher scores better). Linear mixed model used for analysis.|2 Years||||scores on a scale||95% Confidence Interval|Least Squares Mean
1404940|NCT01221441|Primary|Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year|Symptoms, pain and function of the knee joint determined and scored using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation (Total Score, range 0-100 with higher scores better). Linear mixed model used for analysis.|1 Year|Patients with available baseline IKDC scores|||scores on a scale||95% Confidence Interval|Least Squares Mean
1404941|NCT01221363|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to 6 Months Follow-up.|Blood samples are drawn at inclusion and at 6 months follow-up. Change in measured HDL (mmol/L) from baseline to 6 months follow-up|Change in measured HDL from baseline and 6 months follow-up||||mmol/Liter||Standard Deviation|Mean
1404942|NCT01221363|Primary|Change in Objectively Measured Sitting Time From Baseline to 6 Months Follow-up|"Participants wore an ActivePAL monitor for seven days at inclusion and seven days at follow-up. The ActivePAL measures sitting time.~Change in sitting time from baseline to 6 months follow up was evaluated."|7 days of measurement / change in sitting time from baseline and 6 months follow-up|Within group difference|||Hours per day||Standard Deviation|Mean
1404943|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|60 days||||units on a scale||Standard Deviation|Mean
1404944|NCT01221350|Secondary|Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline|"The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 ‘patient-specific’ questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains (http://www.qoltech.co.uk/aqlq.html)."|Baseline||||units on a scale||Standard Deviation|Mean
1404945|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|60 days||||units on a scale||Standard Deviation|Mean
1404946|NCT01221350|Secondary|Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline|Assessment of Quality of life scores with the ACT (Asthma Control Test). The ACT is a way to determine if the asthma symptoms are well controlled. The Asthma Control Test™ (ACT™) is a five question health survey used to measure asthma control in individuals 12 years of age and older. The survey measures the elements of asthma control as defined by the National Heart, Lung, and Blood Institute (NHLBI). ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. Each item includes 5 response options corresponding to a 5-point Likert-type rating scale. In scoring the ACT survey, responses for each of the 5 items are summed to yield a score ranging from 5 (poor control of asthma) to 25 (complete control of asthma).|Baseline||||units on a scale||Standard Deviation|Mean
1404947|NCT01221350|Secondary|Inflammatory IL-4 Sputum Levels at Endpoint|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of IgE in B cells. IL-4 was measured by ELISA.|60 days||||pg/mL||Standard Deviation|Mean
1404948|NCT01221350|Secondary|Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline|Inflammatory IL-4 sputum levels after 60 days of treatment. Sputum induction is a semi-invasive technique used to detect and monitor airway inflammation. IL-4 is a Th2 cytokine that promote airway inflammation in asthma. IL-4 drives the production of immunoglobulin E (IgE) in B cells. IL-4 was measured by ELISA.|Baseline||||pg/mL||Standard Deviation|Mean
1404949|NCT01221350|Secondary|Induced Sputum Eosinophils at Endpoint|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|60 days||||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
1404950|NCT01221350|Secondary|Induced Sputum Eosinophils at Baseline|Eosinophils, a prominent feature of asthma, are found in increased numbers in the circulation and sputum, usually in relation to the severity of asthma.|Baseline||||Eosinophil percentage in sputum cells|Participants|95% Confidence Interval|Mean
1404951|NCT01221350|Primary|Spirometric FEF Values at Endpoint|Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|60 days||||Liters/sec||Standard Deviation|Mean
1404952|NCT01221350|Primary|Spirometric FEF Values at Baseline|Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.|Baseline||||Liters/sec||Standard Deviation|Mean
1404953|NCT01221350|Primary|Spirometric FEV1 Values at Endpoint|Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|60 days||||Liters||Standard Deviation|Mean
1404954|NCT01221350|Primary|Spirometric FEV1 Values at Baseline|Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.|Baseline||||Liters||Standard Deviation|Mean
1404955|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Endpoint|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products.|60 days||||nmol/mg||Standard Deviation|Mean
1404956|NCT01221350|Primary|Spirometric FVC Values at Endpoint|Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|60 days|Per protocol|||Liters||Standard Deviation|Mean
1404957|NCT01221350|Secondary|Induced Sputum Carbonylated Proteins at Baseline|Proteins can become modified by a large number of reactions involving reactive oxygen species. Among these, carbonylation is an irreversible and unrepairable oxidative reaction. The main protein modifications originated from oxidative stress comprise direct oxidation of aminoacids with a thiol group, such as cysteine, oxidative glycation, and carbonylation. Oxidative protein carbonylation induce protein degradation in a nonspecific manner. Chemically, oxidative carbonylation preferentially occurs at proline, threonine, lysine, and arginine, presumably through a metal-catalyzed activation of hydrogen peroxide to a reactive intermediate. Carbonylation usually refers to a process that forms reactive ketones or aldehydes that can be reacted by 2,4-dinitrophenylhydrazine (DNPH) to form hydrazones. Direct oxidation of side chains of lysine, arginine, proline, and threonine residues, among other aminoacids, produces DNPH detectable protein products|Baseline||||nmol/mg||Standard Deviation|Mean
1404958|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint|Change in the induced sputum of antioxidant parameters GSH and GSSG levels after 60 days of treatment. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|60 days||||ratio||95% Confidence Interval|Mean
1404959|NCT01221350|Secondary|Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline|Induced sputum of GSH and GSSG levels at baseline. The ratio GSH/GSSG is considered an index of antioxidant status and reductive -SH groups. GSH and GSSG were measured by a microplate fluorescent assay.|Baseline||||ratio||95% Confidence Interval|Mean
1404960|NCT01221350|Primary|Spirometric FVC Values at Baseline|Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.|Baseline||||Liters||Standard Deviation|Mean
1404961|NCT01221311|Primary|Early Clinical Success|Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.|Post-stent removal (up to one year after enrollment)|The number of participants analyzed is lower than the number of patients randomized, due to patients who dropped out of the study before all stents were removed.|||Participants|||Count of Participants
1404962|NCT01221298|Secondary|Time to Virologic Relapse Through 24 Weeks Post-treatment|Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.|||Days||95% Confidence Interval|Mean
1404963|NCT01221298|Secondary|Time to Failure to Suppress or Rebound During Treatment|The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA <LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA > lower limit of detection (LLOD) for participants who previously achieved HCV RNA < LLOD.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||Days||Standard Error|Mean
1404964|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1404965|NCT01221298|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1405502|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|6 weeks|||||||
1404966|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1404967|NCT01221298|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT). Participants with missing data were imputed as failures.|||percentage of participants|||Number
1404968|NCT01221298|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL).|Week 4 through Week 12|For the percentage of subjects with HCV RNA suppressed below the LLOQ from Week 4 through Week 12 out of all subjects dosed, it was assumed that if 60% of subjects were successfully suppressed from Week 4 through Week 12 then 20 subjects would give a 95% two-sided confidence interval of (36.1%, 80.9%) using binomial exact methods.|||percentage of participants|||Number
1404969|NCT01221285|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants were analyzed to determine if treatment inhibits the in-vitro cockroach antigen binding to B-cells after 6-months of treatment with cockroach SCIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Percent antibody binding||Standard Error|Mean
1404970|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. Numerator is geometric mean post-baseline IgG4; denominator is baseline IgG4. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Number
1404971|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Number
1404972|NCT01221285|Secondary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. Numerator is geometric mean post-baseline IgE; denominator is baseline IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Number
1404973|NCT01221285|Primary|Number of Reported Treatment-related Serious Adverse Events (SAEs)|Number of SAEs reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat|||Events|||Number
1404974|NCT01221285|Primary|Number of Reported Treatment-related Adverse Events (AEs)|Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.|Baseline through 6-months of treatment|Intent-to-treat|||Events|||Number
1404975|NCT01221272|Secondary|Exercise-induced Reversible Total Perfusion Deficit (TPD) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible TPD was derived as the exercise TPD at baseline and at the end of Periods 1 and 2 minus the resting TPD at baseline. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set|||units on a scale||Standard Error|Mean
1404976|NCT01221272|Secondary|Exercise-induced Reversible Perfusion Defect Size (PDS) at Baseline, End of Period 1, and End of Period 2|Exercise-induced reversible PDS was derived as the exercise PDS at baseline and at the end of Periods 1 and 2 minus the resting PDS at baseline. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by SPECT imaging at baseline both at rest and following exercise and following exercise at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set|||percentage of myocardium||Standard Error|Mean
1404977|NCT01221272|Secondary|Perfusion Defect Severity at Baseline, End of Period 1, and End of Period 2|Perfusion defect severity was assessed for each participant as the percentage of the 17 myocardium segments with a relative perfusion defect score of 3 or 4 on a 0-4 scale. Segment scores are: 0 = normal perfusion; 1 = mild reduction in counts-not definitely abnormal; 2 = moderate reduction in counts-definitely abnormal; 3 = severe reduction in counts; 4 = absent uptake (lower scores correspond to less severity and higher scores correspond to increased severity). A lower percentage means fewer segments have severely reduced blood flow. Measurements were obtained by SPECT imaging following exercise at baseline and at the end of Periods 1 and 2.|Up to 33 days|Efficacy Analysis Set|||percentage of segments||Standard Error|Mean
1404978|NCT01221272|Primary|Exercise-induced Total Perfusion Deficit (TPD) Following Ranolazine and Placebo Treatment|TPD is a score that measures the overall impact of a region of decreased myocardial blood flow, incorporating both the amount and severity of the decreased flow. TPD is measured on a scale of 0-100, with higher scores being worse and lower scores being better. Measurements were obtained by SPECT imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set|||units on a scale||Standard Error|Least Squares Mean
1405013|NCT01220401|Primary|Past Week Nightmare Frequency|This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).|pre, one week, two months||||nightmares/week||Standard Deviation|Mean
1404979|NCT01221272|Primary|Exercise-induced Perfusion Defect Size (PDS) Following Ranolazine and Placebo Treatment|PDS is the amount (percent) of the myocardium with decreased blood flow. A lower percentage means more of the myocardium is receiving blood flow. Measurements were obtained by gated single photon emission computed tomography (SPECT) imaging following exercise at the end of the ranolazine and placebo treatment periods.|Up to 33 days|Efficacy Analysis Set: 61 randomized and treated participants with data for both end-of-period (EOP) scans, completed ≥ 7 consecutive days treatment in each period, took the morning dose before each EOP scan, and had baseline perfusion defect size ≥ 5% as measured by QPS imaging software|||percentage of myocardium||Standard Error|Least Squares Mean
1404980|NCT01221090|Secondary|Quality of Life (QOL)|Participants where asked the number of days in the past 30 days in which their physical (phys) and/or mental was not good, and whether their usual activity was affected by their physical/mental health.|12 months|Participants were included if they completed the 12-mo follow-up questionnaire. They also had to have answered questions pertaining to quality of life. Missing responses were not included.|||Number of days||Standard Deviation|Mean
1404981|NCT01221090|Secondary|Diabetes-related Behaviors|Participants were asked the number of days in the past 7 which they participated in various diabetes self-care activities on diet, exercise, home blood glucose monitoring, and foot care.|12 months|Those who completed a questionnaire at baseline and at their 12-month visit were included. Also, they had to have answered questions regarding self-care activities on both surveys since the calculated mean was the average difference in days within the past 7 that individuals participated in self-care activities between 12-months and baseline.|||Days (e.g., Avg diff 12mo vs baseline)||Standard Deviation|Mean
1404982|NCT01221090|Secondary|Patient Self-reported Perceived Health Status||12 months|Perceived health status was collected using a questionnaire administered during the 12-month follow-up visit. Individuals who did not complete the questionnaire during the follow-up visit or who refused to answer the question were not included in the analysis.|||participants|||Number
1404983|NCT01221090|Secondary|BMI|Body mass index|12 months|BMI was computed from height & weight measurements from the 12-month follow-up (f/u) visit. Those unable to come in had height and weight abstracted from their EHRs. Measures recorded fell within the range of 10 days prior to and 45 days after participants’ f/u visit dates. Those missing this information was not included in the analysis.|||kg/m^2||Standard Deviation|Mean
1404984|NCT01221090|Primary|HbA1c|Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation.|12 months|A participant was included in the analysis if he/she had a HbA1c value collected. A longitudinal analysis was performed, with participants contributing one or more HbA1c values to the model. As such, all participants had at least one HbA1c value and were therefore included in the model.|||percentage of gycosylated HbA1c|Participants|Standard Deviation|Mean
1404985|NCT01220973|Primary|PSA Response|PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.|6 months|A total of 27 patients were enrolled but only 26 were evaluable as one patient withdrew consent prior to starting therapy.|||Participants|||Count of Participants
1404986|NCT01220869|Secondary|Cumulative Probability of no PSA Failure|The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.|Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.|||Percentage of participants||95% Confidence Interval|Mean
1404987|NCT01220869|Other Pre-specified|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis.|From Day 28 to Day 168|The PP analysis set included all participants from the FAS analysis set without major protocol violations.|||Percentage of participants||95% Confidence Interval|Mean
1404988|NCT01220869|Secondary|Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28|Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28|From Day 0 to Day 28|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset|||Percentage change of PSA||Inter-Quartile Range|Median
1404989|NCT01220869|Secondary|Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3|Proportion of participants with testosterone at castrate level (<= 0.5 ng/mL) at Day 3|Day 3|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset|||Percentage of participants||95% Confidence Interval|Mean
1405007|NCT01220466|Other Pre-specified|Percentage of Eyes With Induced Manifest Refractive Astigmatism Greater Than 2.00 D of Absolute Cylinder as Compared to the Preoperative Refraction|Induced Manifest Refractive Astigmatism is an increase of astigmatism (cylinder) postoperatively that could be caused by the refractive treatment. An increase of greater than 2.0 D is considered a safety endpoint per ANSI Z80.11-2007.|6 Months|Percentage of eyes with induced manifest refractive astigmatism greater than 2.00 D of absolute cylinder power|||percentage of eyes|Participants|95% Confidence Interval|Number
1404990|NCT01220869|Primary|Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168|Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood’s formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.|From Day 28 to Day 168|The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.|||Percentage of participants||95% Confidence Interval|Mean
1404991|NCT01220739|Primary|Percentage of Participants With Modified Rankin Scale (0 - 1)|Measures the degree of disability or dependence in the daily activities. Minimum score = 0 (best outcome - No symptoms); Maximum Score = 6 (worse outcome - dead)|90 Days from Stroke Onset||||percentage of participants|||Number
1404992|NCT01220739|Primary|Symptomatic Intracranial Hemorrhages||36 hours from tPA initiation||||participants|||Number
1404993|NCT01220609|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients.|||months||95% Confidence Interval|Median
1404994|NCT01220609|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and treated patients|||months||95% Confidence Interval|Median
1404995|NCT01220609|Primary|Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0||Every cycle until completion of study treatment up to 30 days after stopping study treatment|Eligible and evaluable patients.|||Participants|||Count of Participants
1404996|NCT01220609|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years.|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1404997|NCT01220557|Secondary|Evaluation of the Diabetes Education Course|Patients satisfaction with the diabetes education programs was assessed using a self-constructed 12-item scale on specific questions regarding contents and performance of the training. Response mode was a scale ranging from 4 (apply very strong) to 0 (apply not at all). Additionally, patients were asked to give an overall grade for their course ranging from 1 (very good) to 6 (unsatisfactory).|6 month Follow up|||||||
1404998|NCT01220557|Secondary|Treatment Satisfaction / Problem Areas in Dealing With Diabetes|Satisfaction with current diabetes treatment was assessed by a diabetes satisfaction questionnaire developed by Kulzer et al. This questionnaire uncovers problems in dealing with diabetes, also. A high score indicates dissatisfaction with insulin therapy.|6 Month Follow up|||||||
1404999|NCT01220557|Secondary|Diabetes Self-Efficacy Scale|A German version of the Diabetes Self-efficacy Scale was used to assess diabetes specific self-efficacy.|6 Month Follow up|||||||
1405000|NCT01220557|Secondary|CES-D Score|Depressive symptoms were assessed using the German version of the Centre for Epidemiologic Studies Depression Scale (CES-D), an instrument for measuring number and severity of depressive symptoms.|6 month follow up|||||||
1405001|NCT01220557|Secondary|Diabetes Distress Scale (DDS)|Diabetes related distress was assessed by a German version of the Diabetes Distress Scale (DDS). The DDS is a 17-item self-report scale for the assessment of emotional burdens in diabetes treatment in both type 1 and type 2 diabetes.|6 month follow up|||||||
1405002|NCT01220557|Secondary|Summary of Diabetes Self-Care Activities (SDSCA)|The Summary of Diabetes Self-Care Activities (SDSCA) measure is a self-report measure of diabetes self-management assessing several aspects of the diabetes regimen.|6 month|||||||
1405003|NCT01220557|Secondary|Diabetes Empowerment Score (DES)|Empowerment was measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.|6 month follow up|||||||
1405004|NCT01220557|Secondary|Hypoglycaemia Awareness Score|The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.|6 month|||||||
1405005|NCT01220557|Secondary|Diabetes Knowledge|To assess knowledge among insulin-treated diabetes patients, participants completed a new developed 11-item diabetes knowledge score. Each item had to be answered by selecting the correct answer from multiple choices. The numbers of correct answers are summed up; thus, the range of the diabetes knowledge score is between 0 and 11.|6 month|||||||
1405006|NCT01220557|Primary|Changes in Glycemic Control Measured by A1c|Difference between baseline A1c and A1c at 6 month follow up. Equivalent effect on glycemic control measured by A1c (non-inferiority). In case of-non-inferiority test of superiority.|6 month||||Changes in A1c in percentage points||Standard Deviation|Mean
1405014|NCT01220401|Secondary|Beck Depression Inventory|This 21-item, self-report measure was designed to assess the severity of depression among adults. Responses on a Likert-type scale range from 0 – 3, and scores may be summed to derive a total score (0-63), with higher scores indicating more depressive symptoms. Scores of 18 and above have been suggested to reliably identify depressed patients.|Baseline, 1 week, 2 months||||units on a scale||Standard Deviation|Mean
1405015|NCT01220401|Primary|Clinician Administered PTSD Scale|"This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 – 4). This study utilized the “FI/I2” rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis.~Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD."|pre, one week, two months||||units on a scale||Standard Deviation|Mean
1405016|NCT01220401|Primary|Number of Nights With Nightmares|This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).|pre, one week, two months||||nights/week||Standard Deviation|Mean
1405017|NCT01220297|Secondary|Veno-occlusive Disease (VoD)|Assessed as the incidence of veno-occlusive disease (VoD) at 100 days post-transplant.|100 days post-transplant||||Participants|||Count of Participants
1405018|NCT01220297|Secondary|Overall Survival|Overall survival is defined as time from enrollment to time of death or last follow-up, within 2 years.|2 years||||Days||Full Range|Median
1405019|NCT01220297|Secondary|Disease-free Survival (DFS)|Assessed as survival without recurrence of disease|2 years||||Participants|||Count of Participants
1405020|NCT01220297|Secondary|Acute GvHD (Grade 3 to 4)|"Assessed as the incidence of grade 3 to 4 acute GvHD at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage"|100 days post-transplant||||Participants|||Count of Participants
1405021|NCT01220297|Primary|Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)|"Assessed as the incidence of grade 2 to 4 acute graft-vs-host disease (GvHD) at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage"|100 days post-transplant||||Participants|||Count of Participants
1405022|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Participants|||Number
1405023|NCT01220180|Secondary|Number of Participants With PGIC Scale for Fibromyalgia in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Participants|||Number
1405024|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Participants|||Number
1405025|NCT01220180|Secondary|Number of Participants With CGIC Scale for Fibromyalgia in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Participants|||Number
1405026|NCT01220180|Secondary|Number of Participants With PGIC Scale for NeP in PP Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Participants|||Number
1405503|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks|||||||
1405027|NCT01220180|Secondary|Number of Participants With Patient's Global Impression of Change (PGIC) Scale for NeP in ITT Population|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Participants|||Number
1405028|NCT01220180|Secondary|Number of Participants With CGIC Scale for NeP in PP Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Participants|||Number
1405029|NCT01220180|Secondary|Number of Participants With Clinician's Global Impression of Change (CGIC) Scale for NeP in ITT Population|CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.|Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Participants|||Number
1405030|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
1405031|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for Fibromyalgia in ITT Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
1405032|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in PP Population at Week 6|DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
1405033|NCT01220180|Secondary|Change From Baseline in Sleep Interference Score for NeP in ITT Population at Week 6|Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
1405034|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
1405035|NCT01220180|Primary|Change From Baseline in Daily Pain Score for Fibromyalgia in ITT Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was fibromyalgia.|||Units on a scale||Standard Deviation|Mean
1405036|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in PP Population at Week 6|DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|PP population included participants who received the study medication for at least 6 weeks and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
1405037|NCT01220180|Primary|Change From Baseline in Daily Pain Score for NeP in ITT Population at Week 6|Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Baseline and Week 6|ITT population included participants who received at least 1 dose of the study medication and indication of use was NeP.|||Units on a scale||Standard Deviation|Mean
1405038|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in PP Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.|||Percentage of participants|||Number
1405039|NCT01220180|Primary|Percentage of Participants With Improvement in Seizure Frequency in ITT Population|Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.|||Percentage of participants|||Number
1405060|NCT01220128|Primary|Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405040|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Per Protocol (PP) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|PP population included participants who received the study medication for at least 12 weeks and indication of use was epilepsy.|||Percentage of participants||95% Confidence Interval|Number
1405041|NCT01220180|Primary|Percentage of Participants Achieving 28 Days Seizure Free Period in Intent-to Treat (ITT) Population|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study.|Baseline through Week 12|ITT population included participants who received at least 1 dose of the study medication and indication of use was epilepsy.|||Percentage of participants||95% Confidence Interval|Number
1405042|NCT01220128|Primary|Number of Subjects With Breast Cancer Pathological Response|The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present.|During Phase II of the study period, up to Year 3|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405043|NCT01220128|Primary|Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405044|NCT01220128|Primary|Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405045|NCT01220128|Primary|Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405046|NCT01220128|Primary|Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405047|NCT01220128|Primary|Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405048|NCT01220128|Primary|Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405049|NCT01220128|Primary|Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405050|NCT01220128|Primary|Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405051|NCT01220128|Primary|Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405052|NCT01220128|Primary|Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade||During the treatment period and post 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405053|NCT01220128|Primary|Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405054|NCT01220128|Primary|Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405055|NCT01220128|Primary|Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405056|NCT01220128|Primary|Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405057|NCT01220128|Primary|Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405058|NCT01220128|Primary|Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405059|NCT01220128|Primary|Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405061|NCT01220128|Primary|Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405062|NCT01220128|Primary|Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405063|NCT01220128|Primary|Number of Subjects With Anemia, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405064|NCT01220128|Primary|Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405065|NCT01220128|Primary|Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade||During the treatment period and up to 30 days post last vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405066|NCT01220128|Primary|Number of Subjects With Serious Adverse Events SAE(s)|A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE.|From Week 0 to Week 26/32|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405067|NCT01220128|Primary|Number of Patients With Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|During the 31-day (Days 0-30) following vaccination|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405068|NCT01220128|Primary|Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response|At post-GSK2302024A/placebo Dose 4 (Week 13)|For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration. The main analysis for the Phase|According-to-Protocol (ATP) Population for immunogenicity included all eligible patients who did not report major protocol deviation, who had at least received the first 4 doses of study product and provided a valid result for immunogenicity measurement within the 4 weeks following Dose 4.|||Subjects|||Number
1405069|NCT01220128|Primary|Number of Subjects With Severe Toxicities|"Severe toxicity was defined as follows:~A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo~A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at < 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks.~A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo.~A Grade 2 or higher allergic reaction occurring within 24 hours following the administration.~A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration.~A decrease in renal function at the time of administration that was considered as related or possibly related."|During the whole study period, up to Year 3|The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.|||Subjects|||Number
1405070|NCT01219985|Secondary|Lesions Uptake Measurement (SUVmax)|For each detected uptake (in Ungated or CT-based PET images), observers have to report the corresponding maximum standardized uptake value (SUVmax). The SUVmax was obtained automatically in a volume of interest encompassing the entire lesion.|Day 1|The number of participant has been determined on the basis of the annual possible recruitment in the institution to keep the study feasible.|||g/L||Standard Deviation|Mean
1405071|NCT01219985|Primary|Number of Detected Uptakes on PET Images|Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).|day 1|Patients who underwent liver resection|||number of real metastatic lesions|||Number
1405072|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using DAS28-CRP|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-CRP ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day=LDA; DAS28 <2.6 = remission.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1405112|NCT01219855|Secondary|Change From Baseline in Serum 25-hydroxyvitamin D at Week 6|Mean absolute change from baseline in serum total 25-hydroxyvitamin D to end of treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population|||ng/mL||Standard Deviation|Mean
1405504|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|16 weeks|||||||
1405073|NCT01219933|Secondary|Percentage of Participants With LDA or Remission During the Interventional Phase Assessed Using CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission and >2.8 to 10=LDA.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), 8 (12 months), and 9 (24 weeks after V3) or CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1405074|NCT01219933|Secondary|CDAI Score During the Interventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-100 mm VAS; higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405075|NCT01219933|Secondary|SF-36 Subscale Scores During the Interventional Phase|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|ITT Population; n=number of participants analyzed for the given parameter at the specified time point.|||units on a scale||Standard Deviation|Mean
1405076|NCT01219933|Secondary|Short-Form 36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) During the Interventional Phase|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores reflect higher quality of life. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405077|NCT01219933|Primary|Percentage of Participants in the Interventional Phase Who Achieved LDA and Discontinued Oral GC Within 20 Weeks|The percentage of participants with rheumatoid arthritis (RA) with LDA was defined as DAS28 ≤3.2, able to discontinue oral GC within 20 weeks and at the latest at V8, confirmed at the Consolidation Visit without loss of clinical response defined as DAS28 (CRP) >3.2.|Visits 3 (7 months), 4 (8 months), 5 (9 months), 6 (10 months), 7 (11 months), and 8 (12 months)|Intent-to-Treat (ITT) population: all participants included in the interventional GC reduction phase of the study.|||percentage of participants||95% Confidence Interval|Number
1405078|NCT01219933|Primary|Type of GC Taken at the End of the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint|||percentage of participants|||Number
1405079|NCT01219933|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score During the Interventional Phase|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (with the exception of 2 negatively stated), the greater the participant’s fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405080|NCT01219933|Secondary|SJC and TJC During the Interventional Phase|TJC and SJC were assessed for 28 joints. An assessment of 28 joints for swelling and tenderness was made. Joints were assessed and classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) by pressure and joint manipulation on physical examination for a total score range of 0-28. Higher scores indicated greater disease activity (tenderness/swelling). V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint.|||joints||Standard Deviation|Mean
1405081|NCT01219933|Secondary|VAS for Pain (VAS-Pain) During the Interventional Phase|Participants were asked to mark the line corresponding to the intensity of their pain on a 100-mm VAS, where 0=no pain and 100=worst possible pain. The distance from the left edge was measured. Change = V3 mean minus CV mean.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.|||mm||Standard Deviation|Mean
1405082|NCT01219933|Secondary|VAS-Physician's Global Assessment of Disease Activity (GDA) During the Interventional Phase|Physician's were asked to determine the overall GDA for each participant using a 100-mm VAS, where 0=no disease activity and 100=maximum disease activity. The physician marked the line corresponding to their assessment and the distance from the left edge was measured. V3, CV, and the change from V3 to CV was determined.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; n=number of participants analyzed for the given parameter at the specified timepoint. Only participants with values at both visits were included in the analysis.|||mm||Standard Deviation|Mean
1405083|NCT01219933|Secondary|HAQ-DI During the Interventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. V3, CV, and the change from V3 to CV was determined.|Visit 3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405084|NCT01219933|Secondary|DAS28-CRP During the Interventional Phase|DAS28-CRP was calculated from the SJC and TJC using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP) ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. DAS28-CRP values indicated in the CRF were recalculated by the data manager. The cumulative DAS28 (CRP) value (AUC method) was performed using the calculated DAS28. The recalculated values were used in the statistical analyses.|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405085|NCT01219933|Secondary|Time-Averaged GC Dose Changes During the Interventional Phase|"Area Under the Curve (AUC) of GC dose during the interventional phase was determined using the trapezoidal method and was calculated as:~AUC = sigma(Ti+1 - Ti) x [(Di+1+Di)/2]~With Di=dosage at time Ti~It corresponds to the total GC dose received between Baseline (visit 3) and visit 9 and has been calculated only for the 30 patients achieving visit 9."|V3 (7 months) and CV (4 weeks after GC-free status, maximum of 24 weeks after V3)|Safety Int run-in; only participants who completed the study were included in the analysis.|||mg||Standard Deviation|Mean
1405086|NCT01219933|Secondary|Percentage of Participants Able to Discontinue GCs During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; pnly those participants who completed the study at V9 were included in analysis.|||percentage of participants||95% Confidence Interval|Number
1405087|NCT01219933|Secondary|Percentage of Participants Able to Reduce Oral GCs by ≥50 Percent (%) During the Interventional Phase by V9||V9 (24 weeks after V3)|Safety Int run-in; only those participants who completed the study at V9 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1405088|NCT01219933|Secondary|Percentage of Participants Able to Start the GC Reduction Phase at V3|All participants who maintained LDA (defined as DAS28-CRP ≤3.2) from V2 to V3 were included in the interventional phase for reduction of GC.|V3 (7 months)|Safety Int (intervention) run-in: all participants eligible to enter the interventional phase at V2 and who had taken at least 1 dose of MP.|||percentage of participants||95% Confidence Interval|Number
1405089|NCT01219933|Secondary|Percentage of Participants With Changes in RA Treatment During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population|||percentage of participants|||Number
1405090|NCT01219933|Secondary|Number of Participants With Changes in Tocilizumab Dose During the Noninterventional Phase|The dose of tocilizumab could have been reduced from the recommended 8 mg/kg to 4 mg/kg in participants in the case of adverse events.|V1 and V2 (up to 6 months after V1)|Safety Obs Population|||participants|||Number
1405091|NCT01219933|Secondary|Median Dose of Tocilizumab During the Noninterventional Phase||V1 and V2 (up to 6 months after V1)|Safety Obs Population|||mg/kg||Full Range|Median
1405092|NCT01219933|Secondary|Median Time Interval Between V1 and V2|The noninterventional phase was planned to last for a maximum of 6 months per participant. The time between V1 and V2 was measured in months.|V1 and V2 (up to 6 months after V1)|Safety Obs Population|||months||Full Range|Median
1405093|NCT01219933|Secondary|Clinical Disease Activity Index (CDAI) During the Noninterventional Phase|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician Global Assessment (PGA) of disease assessed on 0-100 mm Visual analog scale (VAS); higher scores=greater affection due to disease activity. CDAI total score=0-76. CDAI ≤2.8=disease remission, >2.8 to 10=LDA, >10 to 22=moderate disease activity, and >22=high disease activity.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405094|NCT01219933|Secondary|DAS28-ESR During the Noninterventional Phase|DAS28-ESR was calculated from the SJC and TJC using the 28 joints count and ESR (millimeters per hour [mm/hr]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-ESR ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-ESR <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-ESR values indicated in the CRF were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405095|NCT01219933|Secondary|DAS28-CRP During the Noninterventional Phase|DAS28-CRP was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28-joint count and CRP (mg/L). Total score range: 0 to 10, higher score indicated more disease activity. DAS28-CRP ≤3.2=LDA and >3.2 to 5.1=moderate to high disease activity, and DAS28-CRP <2.6=remission. Timepoint was V2, or before V2 for participants withdrawn before V2; DAS28-CRP values indicated in the Case Report Form (CRF) were recalculated by the data manager. The recalculated values were used in the statistical analyses.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405113|NCT01219855|Primary|Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)|Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.|6 weeks|Per protocol|||percentage of change from baseline||Standard Deviation|Mean
1405505|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|14 weeks|||||||
1405506|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|8 weeks|||||||
1405096|NCT01219933|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) During the Noninterventional Phase|HAQ-DI is a self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. Timepoint was V2, or before V2 for participants withdrawn before V2.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1405097|NCT01219933|Secondary|Percentage of Participants Positive for Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody During the Noninterventional Phase|Anti-CCP antibodies are important markers of bone erosion in RA. Anti-CCP antibodies were classified as positive if >7 U/mL.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1405098|NCT01219933|Secondary|Percentage of Participants Positive for Rheumatoid Factor (RF) During the Noninterventional Phase|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1405099|NCT01219933|Secondary|Number of Erosions During the NonInterventional Phase|In RA, the presence, number, and size of bone erosions and the number of joints with erosions on CRs are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||erosions||Standard Deviation|Mean
1405100|NCT01219933|Secondary|Percentage of Participants With Erosions During the NonInterventional Phase|In RA, the presence, number and size of bone erosions and the number of joints with erosions on conventional radiographs (CRs) are hallmarks for diagnosis, staging and prediction of damage progression and are used for treatment monitoring in randomized controlled studies.|V1 and V2 (up to 6 months after V1)|Safety Obs Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1405101|NCT01219933|Secondary|Percentage of Participants Acheiving Remission Assessed Using DAS28 While Receiving Oral GC on Background TocilizumabTreatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6 = remission.|V1 and V2 (up to 6 months after V1)|Safety Obs population|||percentage of participants|||Number
1405102|NCT01219933|Secondary|Percentage of Participants Able to Acheive LDA Assessed Using DAS28 While Receiving Oral GC on Background Tocilizumab Treatment During the Noninterventional Phase|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the CRP and Patient's Global Assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 and oral GC intake with MP equivalent dose of ≥1 mg and ≤20 mg/day= LDA.|V1 and V2 (up to 6 months after V1)|Safety Obs Population|||percentage of participants|||Number
1405103|NCT01219933|Primary|Number of Participants With GC Switches During the Noninterventional Phase|During the noninterventional phase of the study, once LDA was achieved, GC was switched to MP tablets.|V1 and V2 (up to 6 months after V1)|Safety obs population; n=number of participants analyzed for a given parameter at a specified timepoint|||participants|||Number
1405104|NCT01219933|Primary|Median GC Dose Taken During the Noninterventional Phase|During the noninterventional phase of the study participants received GC as prescribed by the physician. Doses of all GC administered are expressed as MP equivalents.|V1 and V2 (up to 6 months after V1)|Safety obs population; n (number) equals (=) number of participants analyzed for a given parameter at a specified timepoint|||mg||Full Range|Median
1405105|NCT01219881|Secondary|Severity of Coughing|Effect of desflurane versus sevoflurane on the incidence and severity of coughing using a standardized coughing scale|14 days|Determined if patient passed eligibility and completed study.|||Patients with a coughing episode|||Number
1405106|NCT01219881|Secondary|Time to Extubation|Time from gas discontinuation to eye extubation after eye opening|14 days|Determined if patient passed eligibility and completed study.|||Minutes||Standard Deviation|Mean
1405107|NCT01219881|Secondary|Difference in Time to Orientation|Difference in time to orientation as measured by SOMCT between the desflurane group and the sevoflurane group|14 Days|Determined if patient passed eligibility and completed study.|||Minutes||Inter-Quartile Range|Median
1405108|NCT01219881|Primary|Recovery Time|Recovery Time after exposure to desflurane or sevoflurane using a standardized wake up|14 Days|Determined if patients passed all eligibility and completed study.|||Minutes||Inter-Quartile Range|Median
1405109|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6|Proportion of subjects with at least 20% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol population|||participants|||Number
1405110|NCT01219855|Secondary|Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6|Proportion of subjects with at least 30% reduction in plasma intact parathyroid hormone (iPTH) and/or mean iPTH reduction to 70 pg/mL or less at End of Treatment (EOT)|Baseline to End of Treatment (6 weeks)|Per protocol|||participants|||Number
1405111|NCT01219855|Secondary|Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population|Mean percent change from baseline in serum 25-hydroxyvitamin D at End of Treatment (EOT, week 6) in the per protocol population. Subjects in Cohorts 1 and 2 (dose regimens of 60/90 and 30 mcg, respectively) were compared versus their corresponding placebo groups.|Baseline to End of Treatment (6 weeks)|Per protocol population|||percentage of change from baseline||Standard Deviation|Mean
1405114|NCT01219855|Primary|Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).|The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups.|6 weeks|Per protocol|||percentage of participants|||Number
1405115|NCT01219777|Secondary|Toxicity and Response Rates Based on Imaging and Surgical Outcomes|Determine the safety/toxicity of this regimen in this patient population. Estimate the percent of patients undergoing successful cytoreductive surgery to optimal disease (<1 cm greatest tumor diameter) following neoadjuvant chemotherapy with carboplatin, paclitaxel and bevacizumab in patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Assess the 30 day morbidity and mortality following surgical intervention. To describe the response rate for patients treated with neoadjuvant carboplatin, weekly paclitaxel, and bevacizumab using RECIST and GCIG response criteria prior to surgical intervention. Response was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months||||patients|||Number
1405116|NCT01219777|Primary|Tolerated Dose|To determine the maximum tolerated dose of carboplatin AUC5 administered Day 1 Cycles 1-4, weekly paclitaxel 60-80mg/m2 administered on Day 1, 8,and 15 for 3 weeks cycles 1-4, bevacizumab 15mg/kg administered Day 1 Cycles 1-3 prior to surgical intervention.|Up to 6 months||||mg/m^2|||Number
1405117|NCT01219738|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|FEV1 will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participant will be followed up to 6 hours after budesonide dose||||percentage of change from baseline||Standard Error|Mean
1405118|NCT01219738|Primary|Airway Blood Flow (Qaw)|Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.|participants will be followed for 6 hours after budesonide dose||||percentage of change from baseline||Standard Error|Mean
1405119|NCT01219673|Primary|Treatment Effects on 5 Selected Symptoms (Average MDASI-HNC Scores)|Treatments ability to reduce values of 5 symptoms comprised of MD Anderson Symptom Inventory (MDASI)-Head and Neck Cancer (HNC) scores for fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite collected during the 10 weeks of chemoradiation treatment. symptoms that are caused by their disease or by their treatment. Symptom severity score is comprised of average of the five above MDASI core items (fatigue, difficulty swallowing, sleep disturbance, pain, and lack of appetite). Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Total average score range: 0 to 10. Lower scores indicated better outcome.|10 weeks|No analysis was completed. Study terminated with low enrollment.||||||
1405120|NCT01218997|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study|A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.|up to 1 year|All subjects who received at least 1 dose of study drug are included in the safety population.|||Participants|||Number
1405121|NCT01218984|Primary|Slope Change From Baseline for Pupil Size|Photographs of subjects' pupils were measured horizontally and vertically, 15 minutes before the first hydromorphone dose and every 15 minutes after each hydromorphone/placebo for hydromorphone dose, for up to 1 hour. Size was the product of vertical and horizontal measures. The slope, determined by linear regression, was used as a summary measure of the dose-response relationship between the hydromorphone dose and pupil size. The steeper the slope, the greater the hydromorphone effect. A slope of zero indicated no evidence of a hydromorphone effect.|4 weeks (Baseline to Day 28)|Placebo hydromorphone challenge sessions were excluded from the analysis. Results for subjects who discontinued prior to Day 28 were not imputed.|||cm(2)/hr||Standard Deviation|Mean
1405122|NCT01218971|Primary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|Up to 48 weeks (13 injections), not including base study|All participants who received at least 1 dose of study drug are included in the safety population.|||Participants|||Number
1405123|NCT01218958|Secondary|Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)|A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|24 weeks (Baseline to Week 24)||||Participants|||Number
1405124|NCT01218958|Primary|Percentage of Heavy Drinking Days Over the Treatment Period|Drinking rates were assessed from participants' self-reports using the validated Timeline Follow-Back (TLFB) method. Using a TLFB calendar, participants reported the number of days they had consumed alcohol along with the amount they consumed on each day. A heavy drinking day was defined as ≥5 drinks/day for men and ≥4 drinks/day for women.|Baseline through Week 24 (168 days)|The last post-baseline observation carried forward (LOCF) of each participant in the intent-to-treat population (all randomized participants who received at least 1 injection of study drug) were utilized for the primary efficacy analysis.|||Percentage of days|Days|Inter-Quartile Range|Median
1405125|NCT01218867|Secondary|In Vivo Survival of Chimeric T Cell Receptor (CAR) Gene-engineered Cells|Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.|6 years|This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants.||||||
1405126|NCT01218867|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|33 months and 25 days||||participants|||Number
1405507|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|6 weeks|||||||
1405127|NCT01218867|Primary|Response to Therapy|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|6 years||||participants|||Number
1405128|NCT01218802|Primary|Carotid IMT|changes in carotid IMT is a good measure for cardiovascular disease progression|96 weeks|The number of participants who received a final CIMT is less than the number of participants enrolled, due in part to study drop outs and/or invalid data measures.|||percentage change||Standard Deviation|Mean
1405129|NCT01218802|Primary|Bone Mineral Density (BMD)|Measured by change in bone DEXA from baseline to week 96|96 weeks|The total number of participants who received this outcome who had valid data is less than the total number of enrolled participants, due to drop outs before week 96 and/or invalid testing data from DEXA results.|||percentage of change||Standard Deviation|Mean
1405130|NCT01218646|Other Pre-specified|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines.|"Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm.~Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity."|Day 0 up to day 21 post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.|||Participants|||Number
1405131|NCT01218646|Other Pre-specified|Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.|||Participants|||Number
1405132|NCT01218646|Other Pre-specified|Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)"|Day 21 post-vaccination|Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
1405133|NCT01218646|Primary|Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 0 and Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1405134|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers."|Day 21 post-vaccination|Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
1405135|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1405136|NCT01218646|Other Pre-specified|Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older.|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population|||Participants|||Number
1405144|NCT01218438|Secondary|Life Quality Index - 13 Years and Older|"For the age group 13 years and older the respondent will be the participant.~Each of the four domains has a separate score, each has a different range as follows:~Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
1405137|NCT01218646|Primary|Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.|Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|Day 21 post-vaccination|Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (<LLOQ or >ULOQ).|||Titers||95% Confidence Interval|Geometric Mean
1405138|NCT01218594|Primary|Response Rate (RR)|Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).|4 weeks after CCRT|Response rate (RR)include complete response and partial response.|||percentage of participants|||Number
1405139|NCT01218477|Secondary|Number of Participants With Grade 3-4 Abnormalities on Laboratory Test Results|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria of the National Cancer Institute from 1 (least severe) to 4 (life threatening). ANC (*10^9): Grade 3, <1.0- 0.5; Grade 4, <0.5. Hemoglobin (mmol/L): Grade 3, <4.9-4.0; Grade 4, <4.0. Platelet count (*10^9/L): Grade 3, <50.0-25.0; Grade 4, <25. WBCs (*10^9): Grade 3, <2.0-1.0; Grade 4, <1.0. Hypocalcemia (mmol/L): Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia (mmol/L): Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia (mmol/L): Grade 3, <3.0-2.5; Grade 4, <2.5. Hyponatremia (mmol/L), Grade 3, <130-120; Grade 4, <120. Hypermagnesemia (mg/dL): Grade 3, >1.23-3.30; Grade 4, >3.30. Phosphorus (mmol/L): Grade 3, <0.6-0.3; Grade 4, <0.3. Lipase (*ULN): Grade 3, >2.0-5.0; Grade 4, >5.0.|Day 1 to Week 80|All participants who received at least 1 dose of study drug.|||Participants|||Number
1405140|NCT01218477|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, at Least 1 Drug-related AE, and Dose-limiting Toxicities|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment and may or may not be related to treatment. SAE=an untoward medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug. The following drug-related AEs occurring during the first 28 days of treatment with both agents were considered to be dose-limiting toxicities (DLTs): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite adequate medical intervention; ≥Grade 2 AE not controlled by medical intervention and requiring treatment interruption for >7 days.|Day 1 to Week 80, continuously, with observation for dose-limiting toxicities (DLTs) in Weeks 5-8|All participants who received at least 1 dose of study drug|||Participants|||Number
1405141|NCT01218477|Secondary|Percentage of Participants With a Major Hematologic Response (MHR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|MHR was defined as complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR for CML-Adv criteria: white blood cell count (WBC) ≤upper limit normal; absolute neutrophil count (ANC) ≥1,000/mm^3; platelets ≥100,000/mm^3; no blasts or promyelocytes in peripheral blood (PB); basophils <5% in PB; myelocytes + metamyelocytes < 5% in PB; no extramedullary involvement; blasts must be <5%, if bone marrow assessment (BMA) performed. NEL had same criteria, but with lower thresholds for reconstitution of PB counts, as follows: Platelets ≥ 20,000/mm^3 or ANC >500/mm^3. Confirmed MHR obtained if these criteria met and maintained for ≥28 days. CHR for CML-CP criteria WBC ≤10,000/mm^3; platelets <450,000/mm^3; basophils <5% in PB; no blasts or promyelocytes in PB; myelocytes + metamyelocytes <5% in PB; no extramedullary involvement; blasts must be <5% if BMA performed. Confirmed CHR obtained if these criteria met and maintained for ≥28 days. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|Patients without complete hematologic response at dosing start date who received at least 4 weeks of dasatinib and who had at least 1 on-treatment evaluation of both peripheral blood counts and bone marrow cytogenetic response after at least 4 weeks on treatment.|||Percentage of participants||95% Confidence Interval|Number
1405142|NCT01218477|Secondary|Percentage of Participants With a Major Cytogenetic Response (MCyR) in Chronic Myeloid Leukemia-Advanced Phase (CML-Adv) and Chronic Myeloid Leukemia-Chronic Phase (CML-CP)|Cytogenetic response (CyR) was based on the proportion of Philadelphia chromosome-positive (Ph+) cells in metaphase analysis of bone marrow. Complete cytogenetic response (CCyR)=0 Ph+ cells; Partial CyR (PCyR)=1 to 35 Ph+ cells; Minor CyCR= 36-65 Ph+ cells; Minimal CyCR= 66-95 Ph+ cells; No response= >96 Ph+ cells. MCyR=CCyR + PCyR. Nilo=nilotinib; SOR=suboptimal response.|Day 1 to Week 80|All patients without CCyR at dosing start date who received at least 4 weeks of dasatinib and had at least 1 on-treatment cytogenetic evaluation of the bone marrow data after at least 4 weeks on treatment|||Percentage of participants||95% Confidence Interval|Number
1405143|NCT01218477|Primary|Recommended Phase 2 Dose (RP2D) of BMS-833923 Plus Dasatinib in Chronic Myeloid Leukemia-Chronic Phase|The following drug-related adverse events (AEs) occurring in the first 28 days of treatment were considered dose-limiting toxicities (DLT): Grade 4 hematologic AE lasting >7 days; ≥Grade 3 nonhematologic AE, despite medical intervention; ≥Grade 2 AE uncontrolled by medical intervention and requiring treatment interruption for >7 days. RP2D was that dose at which ≤1 of 6 patients had a DLT in the first 4 weeks of treatment. If <3 patients were DLT-evaluable, up to 6 additional patients entered the same dose level. Accrual to a dose level closed if 6 patients were enrolled and <3 were DLT-evaluable. If ≥3 patients at a dose level had no DLTs when a new patient enrolled, the dose was escalated to next level. If 1 DLT was observed in <6 patients, ≥6 patients were required; if no additional DLT was observed, the dose was escalated to the next highest level. If ≥2 DLTs were observed in <6 patients, that level exceeded the RP2D, and the dose was deescalated to the next lowest level.|Day 1 to Week 80, with observation for DLT in Weeks 5-8|Participants who were dose-limiting toxicity (DLT)-evaluable (DLT-evaluable=received combination therapy on >21 of 28 days in Weeks 5 through 8 or interrupted treatment for drug-related AEs)|||mg|||Number
1405159|NCT01218438|Secondary|Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)||Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of participants|||Number
1405145|NCT01218438|Secondary|Life Quality Index - 2 to 12 Years Old|"For the age group 2 to 12 years the respondent will be a parent.~Each of the four domains has a separate score, each has a different range as follows:~Treatment Interference Score Range: 6-42, Therapy-related Problems Score Range: 4-28, Therapy Setting Score Range: 3-21, Cost Score Range: 2-14. Higher scores represent more satisfaction with various aspects of treatment."|Up to 20 months (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
1405146|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older|"TSQM; for the age group 13 years and older the observer will be the participant.~Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.~The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 13 years and older with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
1405147|NCT01218438|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old|"TSQM; for the age group 2 to 12 years the observer will be a parent.~Treatment Satisfaction Questionnaire for Medication (TSQM) is a global satisfaction scale used to assess the overall level of participant’s satisfaction or dissatisfaction with their medications. The following 3 domain were included: effectiveness, convenience, and global satisfaction.~The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Up to 20 months per subject (throughout entire study)|Safety Analysis Set - participants aged 2-12 years old with data (scores) at relevant time points|||Score on a scale||95% Confidence Interval|Median
1405148|NCT01218438|Secondary|Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 14 years and older with scores at each respective time point.|||Scores on a scale||95% Confidence Interval|Median
1405149|NCT01218438|Secondary|Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set participants aged 8 to 13 with scores at each respective time point.|||Score on a scale||95% Confidence Interval|Median
1405150|NCT01218438|Secondary|Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.|Up to 20 months (throughout entire study)|Safety Analysis Set (subset of participants aged 2 to 7 years)|||Score on a scale||95% Confidence Interval|Median
1405151|NCT01218438|Secondary|Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration|Laboratory tests for confirmation of potential hemolysis include Coomb’s test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.|Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40|Safety Analysis Set|||Participants|||Number
1405152|NCT01218438|Secondary|Short Term Tolerance - Change in Body Temperature||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
1405153|NCT01218438|Secondary|Short Term Tolerance - Change in Respiratory Rate||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
1405154|NCT01218438|Secondary|Short Term Tolerance - Change in Heart Rate (Pulse)||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
1405155|NCT01218438|Secondary|Short Term Tolerance - Change in Blood Pressure||Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion at first 3 infusions in Epoch 1 & 2||2017-08-31|08/2017||||
1405156|NCT01218438|Secondary|Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration|"An infusion will be deemed as tolerated unless one of the following occurs:~Any serious related AE(s)~Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion~Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion"|Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of infusions|Infusions||Number
1405157|NCT01218438|Secondary|Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of participants|||Number
1405158|NCT01218438|Secondary|Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs||Up to 20 months (throughout entire study)|Safety Analysis Set|||Infusions|Infusions||Number
1405508|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks|||||||
1405160|NCT01218438|Secondary|Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)|The number of infusions associated with local non-SAEs divided by the total number of infusions.|Up to 20 months (throughout entire study)|Safety Analysis Set|||Percent of infusions|Infusions||Number
1405161|NCT01218438|Secondary|Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion|"The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion (temporally associated) plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug(related), divided by the total number of infusions"|Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
1405162|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions|Within 1 hour of completion of infusion|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
1405163|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant|Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants|Within 1 hour of completion of infusion|Safety Analysis Set|||Adverse events per participant|||Number
1405164|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions|Within 24 hours of completion of infusion|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
1405165|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants|Within 24 hours of completion of infusion|Safety Analysis Set|||Adverse events per participant|||Number
1405166|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion|Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions|Within 72 hours of completion of infusion|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
1405167|NCT01218438|Secondary|Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant|Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants|Within 72 hours of completion of infusion|Safety Analysis Set|||Adverse events per participant|||Number
1405168|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion|Number of all SAEs and AEs divided by number of infusions|Up to 20 months per subject (throughout entire study)||2017-08-31|08/2017||||
1405169|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant|Number of all SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set|||Adverse events per participant|||Number
1405170|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion|Number of related SAEs and AEs divided by number of subjects and divided by number of infusions|Up to 20 months per subject (throughout entire study)|Safety Analysis Set|||Adverse events per infusion|Infusions||Number
1405171|NCT01218438|Secondary|Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant|Number of related SAEs and AEs divided by number of participants|Up to 20 months per subject (throughout entire study)|Safety Analysis Set|||Adverse events per participant|||Number
1405172|NCT01218438|Secondary|Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)|"There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals.~To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured.~The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4.~This was an interim study analysis."|29 weeks|Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4|||Correction factor|||Number
1405173|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mg/L||95% Confidence Interval|Median
1405174|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||Hours (s)||95% Confidence Interval|Geometric Mean
1405175|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mg/L||95% Confidence Interval|Geometric Mean
1405509|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|16 weeks|||||||
1405176|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mL/kg/days||95% Confidence Interval|Geometric Mean
1405177|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||(mg*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
1405178|NCT01218438|Secondary|Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||mg*days/L||95% Confidence Interval|Geometric Mean
1405179|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)|The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||g/L||95% Confidence Interval|Geometric Mean
1405180|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)|The minimum time (Tmax) to reach the maximum concentration (Cmax)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||hours (h)||95% Confidence Interval|Geometric Mean
1405181|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)|The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||g/L||95% Confidence Interval|Geometric Mean
1405182|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)|Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time point|||mL/kg/days||95% Confidence Interval|Geometric Mean
1405183|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||(g*days/L)/(g/kg)||95% Confidence Interval|Geometric Mean
1405184|NCT01218438|Secondary|Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)|The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)|Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18|Safety Analysis Set - sub-groups with data at relevant time points|||g*days/L||95% Confidence Interval|Geometric Mean
1405185|NCT01218438|Secondary|Trough Levels of Anti-Hepatitis B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||mIU/mL||95% Confidence Interval|Geometric Mean
1405186|NCT01218438|Secondary|Trough Levels of Anti-Haemophilus Influenza B Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||mg/L||95% Confidence Interval|Geometric Mean
1405187|NCT01218438|Secondary|Trough Levels of Anti-Tetanus Antibody||"Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||IU/mL||95% Confidence Interval|Geometric Mean
1405188|NCT01218438|Secondary|Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals||"Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish Adjusted Dose in Epoch 2)"|Safety Analysis Set - sub-groups with data at relevant time points|||g/L||95% Confidence Interval|Geometric Mean
1405189|NCT01218438|Secondary|Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)|"IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution;~AUCSC = area under the concentration-time curve following subcutaneous administration;~AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval"|Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18|Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1|||Ratio||90% Confidence Interval|Geometric Mean
1405190|NCT01218438|Secondary|Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated visits/participant||95% Confidence Interval|Number
1405191|NCT01218438|Secondary|Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated days/participant||95% Confidence Interval|Number
1405192|NCT01218438|Secondary|Annual Rate of Hospitalizations for Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated hospitalizations/participant||95% Confidence Interval|Number
1405193|NCT01218438|Secondary|Annual Rate of Days on Antibiotics Per Participant||1 year|Safety Analysis Set|||Estimated days/particpant||95% Confidence Interval|Number
1405194|NCT01218438|Secondary|Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant||1 year|Safety Analysis Set|||Estimated days off/participant||95% Confidence Interval|Number
1405195|NCT01218438|Secondary|Annual Rate of Fever Episodes Per Participant||1 year|Safety Analysis Set|||Estimated episodes/year||95% Confidence Interval|Number
1405196|NCT01218438|Secondary|Annual Rate of Sinus Infections Per Participant||1 year|Safety Analysis Set|||Estimated infections/year||99% Confidence Interval|Number
1405197|NCT01218438|Secondary|Annual Rate of All Infections Per Participant||1 year|Safety Analysis Set|||Estimated infections/year||95% Confidence Interval|Number
1405198|NCT01218438|Primary|Rate of Acute Serious Bacterial Infections Per Year (ASBI)|"Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant.~The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit."|1 year|Safety Analysis Set|||Estimated infections/ year|||Number
1405199|NCT01218399|Secondary|Adverse Events|Number of adverse events as per MEDRA terms|1 week||||Number adverse events|||Number
1405200|NCT01218399|Primary|Percent Forced Expiratory Volume in One Second (FEV1)|"Asthma symptoms scores reported as measure of FEV1 - Forced Expiratory Volume in one second~FEV1 is given which is a standard outcome in asthma studies and is validated by the NIH (NHLBI)~FEV1 of less than 80 is indicative of severe asthma, 80-90 is moderate asthma, over 90 is mild asthma~http://www.med.umich.edu/1info/FHP/practiceguides/asthma/EPR-3_pocket_guide.pdf"|1 week||||% FEV1||Standard Deviation|Mean
1405201|NCT01218308|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
1405202|NCT01218308|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
1405203|NCT01218308|Secondary|Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
1405204|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||subjects|||Number
1405222|NCT01218243|Secondary|Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week|Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.|||ml/second||Standard Deviation|Mean
1405223|NCT01218243|Secondary|Change of Bladder Residual Urine at the 6th Week|Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean|baseline and the 6th week|The data analysis of the secondary outcome was based on the ITT population.|||ml||Full Range|Median
1405205|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above.|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||subjects|||Number
1405206|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||subjects|||Number
1405207|NCT01218308|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects < 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.|During the 7-day (Days 0-6) follow-up period after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet completed.|||subjects|||Number
1405208|NCT01218308|Secondary|Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1405209|NCT01218308|Secondary|Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1405210|NCT01218308|Secondary|Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1405211|NCT01218308|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|On Day 0 and at least 6 months after first vaccination (Month 6)|The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1405212|NCT01218308|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||fold increase||95% Confidence Interval|Mean
1405224|NCT01218243|Primary|Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population.|baseline and the 6th week|The data analysis of the primary outcome was based on the ITT population(data of all participants who are randomized will be analyzed).|||units on a scale||Standard Deviation|Mean
1405213|NCT01218308|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||subjects|||Number
1405214|NCT01218308|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||subjects|||Number
1405215|NCT01218308|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).|At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.|||titers||95% Confidence Interval|Geometric Mean
1405216|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.|To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
1405217|NCT01218308|Secondary|Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.|To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
1405218|NCT01218308|Secondary|Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.|"To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with:~Fever >39°C, and/or at least one of the following manifestations,~Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,~Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis"|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
1405219|NCT01218308|Primary|Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.|To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.|From Day 14 to Day 180|The analysis was performed on the According-To-Protocol cohort for efficacy – Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.|||subjects|||Number
1405220|NCT01218243|Primary|Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population.|baseline and the 6th week|The data analysis of the primary outcome is also based on per-protocol (PP) population as a supportive analysis.|||units on a scale||Standard Deviation|Mean
1405221|NCT01218243|Secondary|Change of International Prostate Symptom Score (IPSS) at the 18th Week|International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean.|baseline and the 18th week|The data analysis of the secondary outcome was based on the ITT population.|||units on a scale||Standard Deviation|Mean
1405225|NCT01218204|Secondary|Trough Concentration of Atorvastatin Metabolite (2-Hydroxyatorvastatin)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were supposed to collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were supposed to collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were supposed to collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16). However no data was collected.|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|||||||
1405226|NCT01218204|Secondary|AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405227|NCT01218204|Secondary|AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A|Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405228|NCT01218204|Secondary|Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose and on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
1405229|NCT01218204|Secondary|Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A|Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||hours||Full Range|Median
1405230|NCT01218204|Secondary|Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405231|NCT01218204|Secondary|Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A|Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405259|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout)|Blood samples were collected at screening, and on Days 1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (White blood cells [WBC], Total neutrophils, Hematocrit and Lymphocytes) are presented for which findings are of PCI either high or low.|Up to Day 28|All subjects Population.|||Participants|||Count of Participants
1405510|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|14 weeks|||||||
1405232|NCT01218204|Primary|Weighted Mean Area Under Concentration Curve From 0 to 24 Hours (AUC [0-24]) Change From Baseline for Triglycerides at Day 14|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was Day -1 value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||millimoles per liter||Geometric Coefficient of Variation|Geometric Mean
1405233|NCT01218204|Primary|Percent Change From Baseline in Lipid Metabolism: LDL/HDL Ratio at Day 14 (24 Hours)|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1405234|NCT01218204|Primary|Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours)|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1405235|NCT01218204|Primary|Percent Change From Baseline in Lipid Metabolism: Apolipoprotein E at Day 14 (24 Hours)|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Perecent change||Standard Deviation|Mean
1405236|NCT01218204|Primary|Percent Change From Baseline for Lipid Metabolism: Apolipoprotein A1 and Apolipoprotein B100 at Day 14|Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.|Baseline and Day 14|All subjects Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
1405237|NCT01218204|Primary|Trough Concentration of Atorvastatin|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were planned to be collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were planned to be collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were planned to be collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was planned to be collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Data was not collected for this outcome measure.||||||
1405238|NCT01218204|Primary|AUC (0-24) of Atorvastatin- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405339|NCT01218048|Secondary|Objective Response (Rate)|The percentage of participants that experienced a response to study treatment, per RECIST 1.0: Number of participant with (Complete Response (CR) + number of participants with Partial Response (PR) / Total number of participants evaluable for response.|Up to 2 years|Participant that where evaluable for response to treatment with cetuximab (400 mg/m2 then 250mg/m2/week) for 3-4 weeks preoperatively, followed by adjuvant chemoradiation with or without cetuximab.|||percentage of participants|||Number
1405239|NCT01218204|Primary|AUC (0-24) of Atorvastatin- Part A|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405240|NCT01218204|Primary|Tmax of Atorvastatin- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at specified time points were analyzed.|||hours||Full Range|Median
1405241|NCT01218204|Primary|Tmax of Atorvastatin- Part A|Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||hours||Full Range|Median
1405242|NCT01218204|Primary|Cmax of Atorvastatin- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).|On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405243|NCT01218204|Primary|Cmax of Atorvastatin- Part A|Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).|On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.|PK parameter Population.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405244|NCT01218204|Primary|Trough Concentration of GSK1292263|Trough samples for GSK1292263 PK (all treatment arms) were planned to be collected early in the morning on Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48h PK sample was collected on Day 16). (pre-dose for Days 13 and 14; trough Day 15 = 24h post last dose; trough Day 16 = 48h post last dose).|On Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK concentration Population. Data was not collected for this outcome measure.||||||
1405245|NCT01218204|Primary|AUC(0-24) of GSK1292263- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405246|NCT01218204|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours [AUC(0-24)] of GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).|On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405247|NCT01218204|Primary|Tlag of GSK1292263- Part B (Pooled Treatment Arm)|Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.|PK parameter Population. Only those participants with data available at the indicated time points were analyzed.|||hours||Full Range|Median
1405248|NCT01218204|Primary|Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
1405249|NCT01218204|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263 on Days 1 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48h sample on Day 1).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population|||hours||Full Range|Median
1405250|NCT01218204|Primary|Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).|On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
1405251|NCT01218204|Primary|Cmax of GSK1292263- Part B (Pooled Treatment Arm)|For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).|On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|PK parameter Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405252|NCT01218204|Primary|Maximum Observed Concentration (Cmax) of GSK1292263- Part A|Serial blood samples for the determination of the PK for GSK1292263 on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).|On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose|Pharmacokinetic (PK) Parameter Population was defined as participants in the ‘PK Concentration’ population for whom PK parameters were derived. The ‘PK Concentration Population' was defined as participants in the ‘All Subjects’ Population for whom a PK sample was obtained and analyzed.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1405253|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm)|Samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24 hours post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Glucose, Total bilirubin, Albumin, Magnesium, CO2/HCO3, Calcium, ALT, AST, Inorganic phosphorus, Potassium and Sodium) are presented for which findings are of PCI either high or low.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
1405254|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in)|Samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Glucose, Magnesium, ALT, AST, Calcium, Inorganic phosphorus and Total bilirubin) are presented for which findings are of PCI either high or low.|Days 14 and 28|All subjects Population.|||Participants|||Count of Participants
1405255|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout)|Samples were collected at screening, and on Days1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Inorganic phosphorus, Sodium, Alanine aminotransferase [ALT], Potassium, Creatinine, Calcium, magnesium, Glucose, Total Bilirubin, Carbon dioxide/bicarbonate [CO2/HCO3] and Aspartate aminotransferase [AST]) are presented for which findings are of PCI either high or low.|Up to Day 28|All subjects Population.|||Participants|||Count of Participants
1405256|NCT01218204|Primary|Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part A|Samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). No parameter was found to have any value of PCI.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
1405257|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part B (Pooled Treatment Arm)|Blood samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24hrs post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24hrs post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Platelet count, Total neutrophils and Lymphocytes) are presented for which findings are of PCI either high or low.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
1405258|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part B (Run-in)|Blood samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Lymphocytes) are presented for which findings are of PCI either high or low.|Days 14 and 28|All subjects Population.|||Participants|||Count of Participants
1405260|NCT01218204|Primary|Number of Participants With Abnormal Hematology Value of PCI- Part A|Blood samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Data for only those parameters (Hematocrit, Hemoglobin and Total neutrophils) are presented for which findings are of PCI either high or low.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
1405261|NCT01218204|Primary|Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm)|Assessment of vital signs including SBP, DBP and heart rate was performed after admission on Day-2, and pre-breakfast on Days -1, 4, and 10 in a fasting state early in the morning (prior to dosing), and at Follow-up. On Days 1, 7 and 14, they were also be taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
1405262|NCT01218204|Primary|Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Run-in)|Assessment of vital signs including SBP, DBP and heart rate was performed on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to day 28|All subjects Population.|||Participants|||Count of Participants
1405263|NCT01218204|Primary|Number of Participants With Vital Signs of PCI- Part B (Washout)|Assessment of vital signs including SBP, DBP heart rate was performed at Screening, on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to day 28|All subjects Population.|||Participants|||Count of Participants
1405264|NCT01218204|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A|Assessment of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate was performed after admission on Day -1 and at Follow-up. On Days 1, 7 and 14, they were taken at pre-dose, 1, 3, 6, 8, 14 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
1405265|NCT01218204|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm)|Single ECGs were taken after admission on Day -2, and pre-breakfast on Days -1, 4, 10, and at Follow-up. On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. The data was found to be abnormal clinically significant in treatment phase.|Up to Day 26|All subjects Population.|||Participants|||Count of Participants
1405266|NCT01218204|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in)|ECGs were taken on Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No data found to be abnormal clinically significant in run-in phase.|Day 28|All subjects Population. Only those participants present during Run in/Day 28 were evaluated/included.|||Participants|||Count of Participants
1405267|NCT01218204|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout)|ECGs were taken at Screening, and on Day1 and Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings.|Up to Day 28|All subject Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1405268|NCT01218204|Primary|Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A|Single ECGs were taken after admission on Day -1 and at Follow-up (up to Day 26). On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No value found to be abnormal clinically significant in Part A of the study.|Up to Day 26|Safety Population.|||Participants|||Count of Participants
1405269|NCT01218204|Primary|Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 26|All subject Population|||Participants|||Count of Participants
1405270|NCT01218204|Primary|Number of Participants With Any AEs and SAEs- Part B (Run-in)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 28|All subject Population|||Participants|||Count of Participants
1405271|NCT01218204|Primary|Number of Participants With Any AEs and SAEs- Part B (Washout)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 28|All subject Population consisted of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1405272|NCT01218204|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|Up to Day 26|Safety Population consisted of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1405273|NCT01218126|Secondary|Total Number of Exacerbations Over 24 Weeks|An exacerbation of COPD is defined as a worsening of COPD symptoms requiring changes to normal treatment (other than increased use of relief salbutamol/albuterol) including antimicrobial therapy, short courses of oral steroids, other bronchodilator therapy and/or emergency treatment or hospitalization.|Up to 24 weeks|ITT population.|||Number of exacerbations|||Number
1405274|NCT01218126|Secondary|Least Square Mean Ratio to Baseline of High Sensitivity C-reactive Protein (HsCRP) Over 24 Weeks|Least square mean ratio to Baseline of HsCRP was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.|Baseline (Week 0) and Week 4, 8, 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Error|Geometric Mean
1405275|NCT01218126|Secondary|Least Square Mean Ratio to Baseline of Plasma Fibrinogen Over 24 Weeks|Least square mean ratio to Baseline of plasma fibrinogen was assessed at Week 4, 8, 12, 24. Blood samples for biomarker analysis were taken at selected visits.|Baseline (Week 0) and Week 4, 8, 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Error|Geometric Mean
1405276|NCT01218126|Secondary|Change From Baseline in Inspiratory Capacity (IC), Residual Volume(RV), Total Lung Capacity(TLC) , Thoracic Gas Volume (TGV) at Functional Residual Capacity ( FRC), Slow Vital Capacity (SVC) at Week 12 and 24|A plethysmograph is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains). Plethysmography was used to assess IC, RV, TGV at FRC, SLV, and TLC. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).|Baseline(Week 0) and Week 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||mL||Standard Error|Least Squares Mean
1405277|NCT01218126|Secondary|Change From Baseline in St Georges Respiratory Questionnaire for COPD (SGRQ-C) at Week 12 and 24|The SGRQ-C questionnaire had 14 questions of COPD and participant had to rate each question. These 14 questions were separated to evaluate the three components of SGRQ-C. These three components were symptom component (question 1 to 7), activity component (question 9 and 12) and impact component (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Change from Baseline was calculated as the specified time point value minus the Baseline value. Baseline visit was Visit 2 (Week 0).|Baseline (Week 0) and Week 12, 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1405278|NCT01218126|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 4, 8, 12, 16, 20 and 24|FVC is the total amount of air exhaled during the lung function test. and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.. Baseline visit was Visit 2 (Week 0).|Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||mL||Standard Error|Least Squares Mean
1405279|NCT01218126|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Sec (FEV1) at Week 4, 8, 12, 16, 20 and 24|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Pre and post-bronchodilator spirometry was performed by the investigator. For post-bronchodilator measurements, spirometry was performed 10-15 minutes after inhalation of 400/360 microgram (mcg) of salbutamol/albuterol. Participants were asked to withhold all bronchodilator therapy (regularly used ipratropium bromide and salbutamol/albuterol used as required) for at least 4 hours prior to spirometric testing. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values.Baseline visit was Visit 2 (Week 0).|Baseline(Week 0) and Week 4, 8, 12, 16, 20 and 24|ITT population. Only those participants with data available at the specified time points were analyzed.|||Millilitre(mL)||Standard Error|Least Squares Mean
1405340|NCT01218048|Secondary|Overall Survival (OS)|Number of patients remaining alive.|Up to 2 years|All patients enrolled in the study.|||participants|||Number
1405511|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|8 weeks|||||||
1405280|NCT01218126|Primary|Change From Baseline in Six Minute Walk Distance (6MWD) at Week 4, 12 and 24|Exercise tolerance was assessed using the 6MWD. If a participant was recorded as having used supplemental oxygen or a walking aid (including sitting down then continuing walking) or a technical problem during a 6MWD then that walk was considered as invalid; otherwise the 6MWD was considered as valid. The baseline 6MWD value was defined as the longest distance walked, for a valid walk, at Visit 2. Variability between the distances walked during the first six-minute walk test (6MWD1) and the second six-minute walk test (6MWD2) being compared was defined as: Variability = [100 x (6MWD2 – 6MWD1)]/6MWD1. Change from Baseline was calculated as the endpoint value minus the Baseline value. Baseline visit was Visit 2 (Week 0).|Baseline (Week 0) and Week 4, 12, 24|Intent-to-treat (ITT) population consisted of all participants randomized to treatment and who received at least one dose of study drug. Only those participants with data available at the specified time points were analyzed.|||Meter (m)||Standard Error|Least Squares Mean
1405281|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-F4co Antibodies|Seropositivity rates for antibodies against F4co antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 42 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1405282|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-RT Antibodies|Seropositivity rates for antibodies against RT antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 125 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1405283|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-Nef Antibodies|Seropositivity rates for antibodies against Nef antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 494 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1405284|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-P24 Antibodies|Seropositivity rates for antibodies against P24 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 119 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1405285|NCT01218113|Secondary|Number of Seropositive Subjects for Anti-P17 Antibodies|Seropositivity rates for antibodies against P17 antigen were assessed using the Enzyme-Linked Immunosorbent Assay (ELISA), with a reference cut-off value greater than or equal to (≥) 187 milli-ELISA units per milliliter (mEL.U/mL).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1405286|NCT01218113|Secondary|Cytokine Expression Profile of RT Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||RT-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
1405287|NCT01218113|Secondary|Cytokine Expression Profile of P24 Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of P24-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P24-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
1405288|NCT01218113|Secondary|Cytokine Expression Profile of P17 Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of P17-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P17-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
1405512|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|6 weeks|||||||
1405289|NCT01218113|Secondary|Cytokine Expression Profile of Nef Antigen-specific CD8+ T-cells|The cytokine co-expression profile was defined by the frequency of Nef-specific CD8+ T-cells expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Nef-specific CD8+ T-cells/million cells||Inter-Quartile Range|Median
1405290|NCT01218113|Secondary|Cytokine Expression Profile of F4co-Computed CD8+ T Cells|The cytokine co-expression profile was defined by the frequency of F4co-Computed CD8+ T-cells [Frequency of CD8+ T cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or TNF-α and/or IFN-γ.|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||F4co-Computed CD8+ T-cells/million cells||Inter-Quartile Range|Median
1405291|NCT01218113|Secondary|Cytokine Expression Profile of RT Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of reverse transcriptase (RT)-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||RT-specific CD4+ T-cells/million cells||Inter-Quartile Range|Median
1405292|NCT01218113|Secondary|Cytokine Expression Profile of P24 Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of P24-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P24-specific CD4+ T-cells/million cells||Inter-Quartile Range|Median
1405293|NCT01218113|Secondary|Cytokine Expression Profile of P17 Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of P17-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||P17-specific CD4+ T-cells/million T-cell||Inter-Quartile Range|Median
1405294|NCT01218113|Secondary|Cytokine Expression Profile of Nef Antigen-specific CD4+ T-cells|The cytokine co-expression profile was defined by the frequency of Nef-specific CD4+ T-cells expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Nef-specific CD4+ T-cells/million cells||Inter-Quartile Range|Median
1405295|NCT01218113|Secondary|Cytokine Expression Profile of F4co-Computed CD4+ T Cells|The cytokine co-expression profile was defined by the frequency of F4co-Computed CD4+ T-cells [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] expressing CD40L and/or IL-2 and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||F4co-computed CD4+ T-cells/million cells||Inter-Quartile Range|Median
1405296|NCT01218113|Secondary|Number of Subjects With Response to at Least 1, 2, 3 or 4 Antigens|Breadth was assessed only for the CD4+ T-cells and was measured by evaluating response to at least 1, 2, 3 or all 4 antigens: proteins 17, 24, Nef, reverse transcriptase (RT).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1405304|NCT01218113|Secondary|Cluster of Differentiation 4 (CD4) Absolute Cell Count|Result determination, using crude values, was done from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening (SCR) to Week (W) 48 for the Control Group.|At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||CD4 cells/cubic millimeter||Standard Deviation|Mean
1405513|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|16 weeks|||||||
1405297|NCT01218113|Secondary|Magnitude of Antigen Specific CD8+ T-cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) – specific CD8+ T-cells and F4co-Computed [frequency of CD8+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD8+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD8+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
1405298|NCT01218113|Secondary|Magnitude of Antigen Specific CD4+ T-cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) – specific CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
1405299|NCT01218113|Secondary|Magnitude of Antigen Specific CD40L-CD4+ T-cells Expressing at Least One Cytokine.|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) – specific CD40L-CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L-CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD40L-CD4+ T-cells/million T-cells||Inter-Quartile Range|Median
1405300|NCT01218113|Secondary|Magnitude of Antigen Specific CD40L+CD4+ T-cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) – specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2) or another cytokine among interferon-gamma (IFN-γ) and/or tumour necrosis-alpha (TNF-α), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD40L+CD4+ T-cells/million T-cells||Inter-Quartile Range|Median
1405301|NCT01218113|Secondary|Magnitude of Antigen Specific Cluster of Differentiation-40 Ligand (CD40L)+CD4+ T-cells Expressing at Least Interleukin-2 (IL-2)|Magnitude was defined as the frequency of proteins 17, 24, Nef, reverse transcriptase (RT) – specific CD40L+CD4+ T-cells and F4co-Computed [frequency of CD4+ T-cells expressing markers in the response to the F4co fusion protein was estimated by adding individual frequencies of CD4+ T-cells to each of the 4 antigens (Nef, p17, p24, RT)] CD40L+CD4+ T-cells expressing at least interleukin- 2 (IL-2), as assessed by Intracellular Cytokine Staining (ICS).|During the entire study period - up to Week 48 (Pre-vaccination, Weeks 6, 28, 30 and 48 for the 3D_HIV Group, 2D_HIV Group and Control Group and at Pre-vaccination, Weeks 6 and 28 for the HIV Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom CMI assay or humoral results were available against at least one study vaccine antigen component after vaccination.|||CD40L+CD+ T-cells/million cells||Inter-Quartile Range|Median
1405302|NCT01218113|Secondary|Percentage of Subjects With ART (Anti-Retroviral Therapy) Initiation and HIV-related Clinical Events|Only actual ART initiations were reported under the category “ART initiation”. HIV-related clinical events were defined as: clinical disease progression, or confirmed VL > 100.000 copies/mL, or confirmed CD4 cell count < 350 cells/ cubic millimeter (mm3).|During the entire study period (up to Week 48)|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||Percentage of participants|||Number
1405303|NCT01218113|Secondary|Mean Change in CD4 Cell Count From Baseline|Baseline for CD4 cell count analysis was defined as the mean of values measured in blood taken at Screening and at pre vaccination (PRE). Result determination, using crude values, was done from week 1 to 28 for the HIV Group, weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from week 1 to week 48 for the Control Group.|At Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||CD4 cells/cubic millimeter||Standard Deviation|Mean
1405305|NCT01218113|Secondary|Percentage of Subjects With Plasmatic HIV-1 Viral Load Decrease Higher Than (>) 1|The proportion of subjects with >1 decrease of HIV-1 VL, was determined using log10-transformed values.|At Week 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||Percentage of participants|||Number
1405306|NCT01218113|Secondary|Levels of HIV-1 VL|HIV-1 VL, using log10 transformed values, was expressed in log10-RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.|At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||log10 (RNA Copies/mL)||Inter-Quartile Range|Median
1405307|NCT01218113|Secondary|Levels of HIV-1 Viral Load (VL)|HIV-1 VL, using crude values, was expressed in RNA copies/mL and measured from Screening to Week 28 for the HIV Group, Weeks 30, 38 and 48 for the 3D_HIV Group and 2D_HIV Group and from Screening to Week 48 for the Control Group.|At Screening, Pre-vaccination and at Weeks 1, 4, 6, 16, 28, 30, 38 and 48|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||RNA Copies/mL||Inter-Quartile Range|Median
1405308|NCT01218113|Secondary|Geometric Mean Change in HIV-1 VL From Baseline|Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 29 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.|At Weeks 1, 4, 6, 16, 28, 30 and 38|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||log10(RNA copies/mL)||Standard Deviation|Geometric Mean
1405309|NCT01218113|Secondary|Geometric Mean Change in HIV-1 Viral Load (LV) From Baseline|Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/mL. Baseline of HIV-1 viral load was defined as the geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic. Changes from baseline were measured at Week 1 to 28 for the HIV Group, Weeks 30 and 38 for the 3D_HIV Group and 2D_HIV Group and from Week 1 to Week 38 for the Control Group.|At Weeks 1, 4, 6, 16, 28, 30 and 38|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||RNA copies/mL||Standard Deviation|Geometric Mean
1405310|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 48|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1405311|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 38|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1405312|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 30|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1405319|NCT01218113|Primary|Number of Subjects With Potentially Immune-Mediated Diseases (pIMDs)|Potentially Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (up to Week 48)|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1405320|NCT01218113|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (up to Week 48)|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1405313|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 28|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
1405314|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 16|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
1405315|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 6|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
1405316|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Week 4|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and Dose 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
1405317|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|Pre-vaccination, at Week 0|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.|||Participants|||Count of Participants
1405318|NCT01218113|Primary|Number of Subjects With Abnormal Haematological and Biochemical Values|Among the biochemical and haematological parameters with abnormal values were alanine aminotransferase [ALT], albumin [ALB], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin (total) [BIL], creatinine [CRE], eosinophils [EOS], eosinophils/100 leukocytes [EOS/100LEU], bicarbonate [BIC], haemoglobin [HGB], potassium [PTS], lymphocytes [LYM], lymphocytes/100 leukocytes [LYM/100LEU], sodium [SDI], neutrophils [NEU], neutrophils/100 leukocytes [NEU/100LEU], platelet count [PLC], prothrombin time-international normalized ratio [PTT] and white blood cell count [WBC]. Assessed grades (G) for laboratory parameters were 0, 1 (mild), 2 (moderate), 3 (severe) and 4 (potentially life-threatening), according to DAIDS (division of AIDS table for grading the severity of adult and pediatric adverse events -Version 1.0).|At Screening|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since the screening timepoint was identical for both groups.|||Participants|||Count of Participants
1405321|NCT01218113|Primary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 3 and across doses.|During the 28-Day (Days 0-27) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1405322|NCT01218113|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 (G3) AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. Unsolicited AEs were tabulated following Dose 1 and Dose 2 vaccinations.|During the 28-Day (Days 0-27) period following Dose 1 and Dose 2|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 and 2 vaccinations were identical for both groups.|||Participants|||Count of Participants
1405323|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1405324|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) period following Dose 3|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1405325|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) period following Dose 2|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.|||Participants|||Count of Participants
1405336|NCT01218087|Primary|Cranial Abnormalities Were Measured at Hospital Discharge|Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.|up to 120 days||||% participant cranial abnormalities|||Number
1405337|NCT01218048|Secondary|Change in Tumor Size|Largest percent change (decrease) in tumor size before and after neoadjuvant cetuximab.|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)||||percent|||Number
1405338|NCT01218048|Secondary|3-year Progression-free Survival (PFS)|Percentage of participants alive at 3 years that did not experience disease progression per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.|3 years||||percentage of participants||95% Confidence Interval|Number
1405326|NCT01218113|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms(smt.)were abdominalpain,anorexia,diarrhoea,fatigue,headache,myalgia,nausea,sweating,temperature(Temp.)orally=temp.37.7degreesCelsius(°C)&vomiting.Any=occurrene of smt.regardless of intensity.Grade3(G3)Abdominal pain/fatigue/myalgia/sweating/headache=symp.causing inability to perform usual social&functional activities.Medicallyattended(MA)Abdominalpain/fatigue/myalgia/sweating/headache=smt.causing inability to perform basic self-care activities.G3Anorexia=loss of appetite associated with significant weight loss.MAanorexia=aggressive intervention indicated.G3diarrhoea=blood/increased≥7stools per24hours(h)/4fluid replacement.G3nausea=persistent nausea resulting in minimal oral intake for more than48h/with aggressive rehydration indicated.G3vomiting=persistent vomiting resulting in orthostatic hypotension/aggressive.MAdiarrhoea/nausea/vomiting=smt.with life threatening consequences.Related=smt.assessed by the investigator as being related to vaccination|During the 7-day (Days 0-6) period following Dose 1|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.|||Participants|||Count of Participants
1405327|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) post-vaccination period, across doses|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1405328|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) period following Dose 3|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1405329|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) period following Dose 2|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 2 vaccination was identical for both groups.|||Participants|||Count of Participants
1405330|NCT01218113|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of symptom regardless of intensity. Grade 3 Pain = pain that prevented normal every day activities. Grade 3 Redness/Swelling = redness or swelling associated with ulceration or secondary infection/phlebitis/sterile abscess/drainage. Medically attended (MA) Pain = pain causing inability to perform basic self-care function or Hospitalization indicated for management of pain. Medically attended Redness/Swelling = redness or swelling associated with necrosis.|During the 7-day (Days 0-6) period following Dose 1|The analysis was performed on the Total Vaccinated cohort, which included subjects with at least one vaccine administration documented, who had their symptom sheets filled in. For the purpose of the analysis, 3D_HIV Group and 2D_HIV Group were combined into a single group (HIV Group), since Dose 1 vaccination was identical for both groups.|||Participants|||Count of Participants
1405331|NCT01218113|Primary|Geometric Mean Change in HIV-1 VL From Baseline|Changes from baseline in HIV-1 viral load (difference of each value minus baseline value) were obtained using log10-transformed values and expressed in log10-RNA copies/mL. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.|At Week 48, post-Dose 3|The analysis was performed on the Modified Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||log10(RNA copies/mL)||Standard Deviation|Geometric Mean
1405332|NCT01218113|Primary|Geometric Mean Change in Human Immunodeficiency Virus Type 1 (HIV-1) Viral Load (VL) From Baseline|Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter [copies/mL]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.|At Week 48, post-Dose 3|The analysis was performed on the Modified Total vaccinated cohort, which included all subjects with at least one vaccine administration documented who complied with the protocol-defined criteria and with sufficient data to perform the efficacy analysis.|||RNA copies/mL||Standard Deviation|Geometric Mean
1405333|NCT01218100|Secondary|The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)||||mm HG||Standard Deviation|Mean
1405334|NCT01218100|Primary|The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.||Visit 6/(Week 0) and Visit 9/(Week 6)||||mm HG||Standard Deviation|Mean
1405335|NCT01218087|Secondary|Incidence of Cardiorespiratory|daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside|daily up to 120 days||||cardioresp. events/100hrs of device use|||Number
1405341|NCT01218048|Secondary|Progression-free Survival (PFS)|The length of time during and after study treatment that participants lived with disease that did not progress per RECIST 1.0. Progression per RECIST 1.0 is defined as a 20% increase the in longest dimension (LD) lesion from Nadir.|Up to 54 months||||months||Full Range|Median
1405342|NCT01218048|Secondary|Frequency of EGFR-specific T Cells (EGFR853-861 Peptide-specific Tetramer+ CD8+T Cells)|Difference in frequency of circulating EGFR-specific T cells between cetuximab-treated and cetuximab-naive patients|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)||||EGFR+ T cells/10^4 T cells||Full Range|Mean
1405343|NCT01218048|Primary|T Cell Activation|T cell activation measured at pre-/post-cetuximab exposure|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)|Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.|||percentage of T cell activation||Inter-Quartile Range|Median
1405344|NCT01218048|Primary|Serum Cytokines Levels|Serum cytokines levels measured at pre-/post-cetuximab, exposure measured in picogram per milliliter of plasma (pg/ml)|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)|Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.|||pg/ml||Inter-Quartile Range|Median
1405345|NCT01218048|Primary|NK Cell Activation|Cetuximab-mediated NK cell activation (percentage of activity) measures at pre-/post-cetuximab exposure for patients in peripheral blood lymphocytes (PBL) and tumor infiltrating lymphocytes (TIL) and in those patients that did and did not respond to treatment.|Prior to each weekly cetuximab treatment (up to 4 weeks); at the time of surgery (at 3-4 weeks after first cetuximab treatments)|Participants that received preoperative treatment with single-agent cetuximab for a minimum of 3-4 weeks.Patients defined as responders, demonstrated upregulation of CD137 on tumor infiltrating NK cells following cetuximab therapy compared with non-responders.|||percentage of activity||Inter-Quartile Range|Median
1405346|NCT01218009|Post-Hoc|Pulse at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Heart rate was measured by radial pulse.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population|||beats/minute||Standard Deviation|Mean
1405347|NCT01218009|Post-Hoc|Blood Pressure at Screening and End of Study|Vital sign measurements (heart rate and blood pressure) were evaluated as part of the safety profile assessment. The participant was seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer was used.|Days -15 to -8 (Screening), up to Day 49 (End of study)|Safety population|||mmHg||Standard Deviation|Mean
1405348|NCT01218009|Primary|Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator|Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
1405349|NCT01218009|Primary|Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator|A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
1405350|NCT01218009|Primary|Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator|Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
1405351|NCT01218009|Primary|Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator|A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.|Days -15 to -8 (Screening), Week 12, Week 52|Safety population. The study was terminated prior to the during study evaluations.||||||
1405352|NCT01218009|Primary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 49 (study termination)|Safety population|||participants|||Number
1405353|NCT01217957|Secondary|Phase 2: 1 Year Survival Rate|1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.|1 year after first dose of study drug||||percentage of participants||95% Confidence Interval|Number
1405354|NCT01217957|Secondary|Phase 2: Progression Free Survival (PFS)|PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.|Up to 787 days|The mITT population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.|||months||95% Confidence Interval|Median
1405355|NCT01217957|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|Participants from the Response Evaluable Population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with data available for analysis. Patients who did not experience PD were censored at the last response assessment that was SD or better.|||months||95% Confidence Interval|Median
1405356|NCT01217957|Secondary|Phase 2: Time to Best Response|Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.|Up to 787 days|Participants form the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.|||months||Full Range|Median
1405357|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.|Cycles 3, 6, 9 and 12 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1405358|NCT01217957|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)|Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|After Cycles 3, 6 and 9 (Up to 787 days)|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1405359|NCT01217957|Secondary|Phase 2: Overall Response Rate (ORR)|ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to < 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Up to 787 days|The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
1405360|NCT01217957|Secondary|Phase 2: Overall Survival (OS)|OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.|From the first dose of study treatment to the date of death (up to 787 days)|Safety Population included al participants who received 1 of the 3 study drugs. Participants who did not die were censored at the last study visit.|||participants||95% Confidence Interval|Median
1405361|NCT01217957|Secondary|Phase 2: Time to Progression (TTP)|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).|From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)|The modified Intent-to-Treat (mITT) population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.|||months||95% Confidence Interval|Median
1405362|NCT01217957|Secondary|Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome|TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory’s performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose|||||||
1405363|NCT01217957|Secondary|Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome|Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory’s performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.|Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose|||||||
1405374|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period|Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period|Day 1 prior to month 6 and prior to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment|||injections||Standard Deviation|Mean
1405364|NCT01217957|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.|Cycle 1, Day 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.|||Ratio||Standard Deviation|Geometric Mean
1405365|NCT01217957|Secondary|Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.|||hr*ng/mL||Standard Deviation|Geometric Mean
1405366|NCT01217957|Secondary|Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with data available.|||hours||Full Range|Median
1405367|NCT01217957|Secondary|Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib|Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 15|The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.|||ng/mL||Standard Deviation|Geometric Mean
1405368|NCT01217957|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.|||percentage of participants|||Number
1405369|NCT01217957|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone|MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.|||mg/m^2|||Number
1405370|NCT01217957|Primary|Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone|RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|All Phase 1 participants.|||mg/m^2|||Number
1405371|NCT01217957|Primary|Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone|ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or; 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)|Participants from the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.|||percentage of participants||95% Confidence Interval|Number
1405372|NCT01217957|Primary|Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)|The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.|||participants|||Number
1405373|NCT01217944|Secondary|Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period|Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.|Month 3 up to month 12|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment.|||injections||Standard Deviation|Mean
1405375|NCT01217944|Secondary|Number of Ranibizumab Injections Received Prior to Month 3|In order to describe exposure to the study drug the number of ejections was evaluated|Day 1 and prior to month 3|The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment|||injections||Standard Deviation|Mean
1405376|NCT01217944|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye|CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient’s fluorescein angiography and color fundus photography images provided by investigators.|Baseline and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
1405377|NCT01217944|Secondary|Change From Baseline in Central Retinal Thickness of the Study Eye Over Time|Retinal thickness was measured by Central Reading Center using patient’s Optical Coherence Tomography (OCT) images provided by investigators.|Baseline, Month 3, Month 6 and Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Microns||Standard Deviation|Mean
1405378|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
1405379|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
1405380|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.|Months 6 and 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
1405381|NCT01217944|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.|Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Percentage of Patients|||Number
1405382|NCT01217944|Secondary|Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12|Baseline and Month 1 through Month 12|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Letters||Standard Deviation|Mean
1405383|NCT01217944|Secondary|Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.|Baseline and Month 6|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Letters||Standard Deviation|Mean
1405384|NCT01217944|Primary|Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye|The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.|Baseline, Month 1 through Month 3|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward|||Letters||Standard Deviation|Mean
1405385|NCT01217892|Secondary|Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.|To compare the adjusted proportions controlling for baseline HbA1c [acc. to Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu] of participants with HbA1c <7.0% achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment, in patients who had HbA1c ≥7.0% at baseline.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1405421|NCT01217463|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition|Wound closure is defined as 100% reepithelialization of the target DFU, without exudate.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
1405386|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||mg/dL||Standard Error|Least Squares Mean
1405387|NCT01217892|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1|To compare the change from baseline in fasting plasma glucose (FPG) achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 1 week of double-blind treatment.|Baseline to Week 1|Full Analysis Set, participants with non-missing baseline and Week 1 values|||mg/dL||Standard Error|Least Squares Mean
1405388|NCT01217892|Secondary|Adjusted Percent Change in Body Weight|To compare the percent change from baseline in body weight achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID, and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||Percent||Standard Error|Least Squares Mean
1405389|NCT01217892|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) values|||Percent||Standard Error|Least Squares Mean
1405390|NCT01217840|Secondary|Adiponectin at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
1405391|NCT01217840|Secondary|C-reactive Protein (CRP) at Baseline and Week 24|Outcome was assessed using high-sensitivity C-reactive protein (hs-CRP) test.|Baseline; Week 24|Patients who completed the study were analyzed.|||mg/L||Standard Error|Mean
1405392|NCT01217840|Secondary|Tumor Necrosis Factor-alpha (TNF-α) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
1405393|NCT01217840|Secondary|Interleukin-10 (IL-10) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
1405394|NCT01217840|Secondary|Interleukin-6 (IL-6) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||pg/mL||Inter-Quartile Range|Median
1405395|NCT01217840|Secondary|Hemoglobin A1C (HgbA1c) at Baseline and Week 24|HbgA1c is a test to measure of the glucose (blood sugar) level over the past 2-3 months.|Baseline; Week 24|Patients who completed the study were analyzed.|||Percentage of glycosylated hemoglobin||Standard Error|Mean
1405396|NCT01217840|Secondary|High-density Lipoprotein (HDL) at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||mg/dL||Standard Error|Mean
1405397|NCT01217840|Secondary|Triglycerides at Baseline and Week 24||Baseline; Week 24|Patients who completed the study were analyzed.|||mg/dL||Standard Error|Mean
1405398|NCT01217840|Primary|25OH Vitamin D|Primary outcome is serum 25OH vitamin D concentrations|Baseline; Week 24|Patients who completed the study were analyzed.|||ng/mL||Standard Error|Mean
1405399|NCT01217827|Primary|Referral for Implantable Cardioverter Defibrillator||6 months||||participants|||Number
1405400|NCT01217814|Secondary|Pharmacokinetic (PK) Parameter: Serum Concentration of Functional and Bound Sarilumab||Week 12|Analysis was performed in PK population of all participants with at least one non-missing serum concentration data.|||ng/mL||Standard Deviation|Mean
1405401|NCT01217814|Secondary|Percentage of Participants Achieving DAS28 Remission Score < 2.6 at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1405402|NCT01217814|Secondary|European League Against Rheumatism (EULAR) Response at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1405403|NCT01217814|Secondary|Disease Activity Score for 28 Joints (DAS28) at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1405404|NCT01217814|Secondary|Percentage of Participants Who Achieved at Least 70% Improvement in American College of Rheumatology Core (ACR70) Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1405405|NCT01217814|Secondary|Percentage of Participants Who Achieved at Least 50% Improvement in American College of Rheumatology (ACR50) Core Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1405406|NCT01217814|Primary|Percentage of Participants Who Achieved at Least 20% Improvement in American College of Rheumatology (ACR20) Core Set Disease Activity Index at Week 12||Week 12|As the number of participants randomized fell well below target (16 vs. 250), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
1405407|NCT01217801|Primary|Area Under Plasma Concentration|Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.|Day 1 and Day 7|All that completed a period|||ng*hr/ml||Standard Deviation|Mean
1405408|NCT01217749|Primary|Safety During Dose-Limiting Toxicity (DLT) Observation Period|Number of dose-limiting toxicities observed in the first 6 participants enrolled in treatment Groups 1 and 2|56 days for Group 1 and 28 days for Group 2||||participants who experienced DLT|||Number
1405420|NCT01217463|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
1405409|NCT01217749|Secondary|Progression Free Survival (PFS) at 12 Months|"Progressive disease for CLL (Hallek) is characterized by ≥1 of the following:~Appearance of any new lesion, eg lymph nodes (> 1.5 cm), de novo hepatomegaly or splenomegaly, or other organ infiltrates~Increase of ≥50%~in longest diameter of any previous site~in hepatomegaly or splenomegaly~in blood lymphocytes with ≥5x109/L B cells with enlarging lymph node, liver, or spleen~Progressive disease for B cell lymphoma (Cheson) is characterized by any new lesion or increase by ≥ 50% of previously involved sites from nadir:~Appearance of a new lesion(s) >1.5 cm in any axis, ≥ 50% increase in the SPD of >1 node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis~Lesions PET+ if FDG-avid lymphoma or PET+ before therapy~50% increase from nadir in the SPD of any liver or spleen lesions~New or recurrent BM involvement~Increase of ≥50% in blood lymphocytes with ≥5x109/L B cells within enlarging lymph node, liver, or spleen"|From first dose of study treatment until disease progression, death, or until 12 months||||percentage of event free participants||95% Confidence Interval|Mean
1405410|NCT01217749|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of study treatment to within 30 days of last dose or until study closure||||participants|||Number
1405411|NCT01217749|Primary|Percentage of Participants Achieving Response|The primary endpoint for the study was overall response rate (ORR), defined as the proportion of participants who achieved a best overall response of complete response (CR), CR with incomplete blood count recovery (Cri), or partial response (PR), according to the guidelines from the International Workshop on Chronic Lymphocytic Leukemia (IWCLL1) published in 2008 for CLL participants and International Working Group for non-Hodgkin’s lymphoma (IWG NHL) 2007 criteria for SLL participants, with the modification that treatment-related lymphocytosis will not be considered progressive disease, as evaluated by the investigators. Assessment of disease is based on radiological exams, physical exam, hematological evaluations and, when appropriate, bone marrow results.|The median follow-up time on study for all treated participants is 12.5 (range 0.5-19.6) months||||percentage of participants||95% Confidence Interval|Number
1405412|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Analysis of Covariance (ANCOVA)|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by ANCOVA.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1405413|NCT01217606|Secondary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Mixed-Effect Model for Repeated Measure|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed by a mixed-effect model for repeated measure.|Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Month 6, Month 9, Month 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation and who have data at the noted time point (no missing imputation)|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1405414|NCT01217606|Primary|Change From Baseline in Mean Worse Eye Intraocular Pressure (IOP) Analyzed by Two-Sample T-Test|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP is evaluated at Hour 0 and Hour 2 in the worse eye, defined as the eye with the worse (higher) Hour 0 IOP at baseline. The mean of Hours 0 and 2 is calculated at Baseline and Week 12 in the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are analyzed using a two-sample t-test.|Baseline, Week 12|Modified Intent to Treat: all randomized patients with at least one post-baseline efficacy evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1405415|NCT01217515|Secondary|Assessment of Adverse Events, Clinical Laboratory Results, Vital Signs and Sensitivity Reactions|Number of subjects with adverse events, abnormal clinical laboratory results, vital signs and occurrence of any local sensitivity reactions. Data are presented where the incidence is greater than or equal to 5%.|8 weeks||||percentage of participants|||Number
1405416|NCT01217515|Secondary|Patient's Global Impression of Improvement (PGI-I)|Compared to the way you felt prior to starting the study treatment, how would you now describe your problems related to the anal fissure?” Responses will be measured on a 7-point Likert scale where 1 = substantially worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = substantially improved. Percentage of subjects scoring 5,6 or 7 was assessed.|4 weeks||||percentage of participants|||Number
1405417|NCT01217515|Primary|Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation for Week 4 (for the 7 Treatment Days Immediately Preceding the Week 4 Visit).|Change from baseline in average of worst anal pain associated with or following defaecation for Week 4 (for the 7 treatment days immediately preceding the Week 4 visit). Numerical Rating Scale, range 0-10 where 0 = no pain and 10 = worst pain imaginable.|4 weeks||||units on a scale||Standard Error|Mean
1405418|NCT01217476|Secondary|Relative Wound Area Regression of 40% or More at 6 Week|The incidence of wound area regression of at least 40% at week 6 was considered as an important exploratory secondary efficacy variable. The wound area regression was calculated as percentage change from inclusion at week 6 using centralized wound area data.|6 weeks|The analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
1405419|NCT01217476|Primary|Wound Closure Rate of Diabetic Foot Ulcers (DFUs) of Neuropathic Origin After a Maximum of 12 Weeks Topical Daily Application of Trafermin 0.01% Spray Compared With Placebo, in Addition to Best Local Cares|wound closure is defined as 100% reepithelialization of the target DFU, without exudates.|12 weeks|The primary analysis of the efficacy criteria was conducted on the ITT population.|||percentage of participants|||Number
1405514|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|2 weeks|||||||
1405422|NCT01217411|Primary|Response Rate (Complete or Partial Response) (Phase II)|Only participants with measurable disease present at baseline, received at least 6 weeks of therapy, and had disease re-evaluated considered evaluable for response. Complete Response (CR): Disappearance all lesions; Partial Response (PR): =/>50% decrease in sum bidimensional products all lesions reference baseline sum of bidimensional products of all lesions; Progressive Disease (PD): >25% increase in sum bidimensional products of lesions, or progression of any treated lesion not target lesion, or appearance of 1 or > new lesions at least 6 mm in unidimensional size. Stable Disease (SD): Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum of bidimensional products of all lesions.|12 weeks|||||||
1405423|NCT01217411|Primary|MTD of RO4929097 in Combination With Stereotactic Surgery (SRS)|MTD of RO4929097 in combination with SRS, determined according to incidence of DLT graded using the NCI CTCAE version 4.0 (phase I)|4 weeks|Analysis was not available due to small number of patients on the study.||||||
1405424|NCT01217411|Primary|Maximum-tolerated Dose (MTD) of RO4929097 in Combination With Whole-brain Radiotherapy (WBRT)|Maximum-tolerated dose (MTD) of RO4929097 in combination with WBRT, determined according to incidence of dose limiting toxicity (DLT) graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|4 weeks|Analysis was not available due to small number of patients on the study.||||||
1405425|NCT01217307|Secondary|Cardiac MRI After 4 Months, Per Protocol Analysis|A per-protocol analysis, excluding patients diagnosed with new onset diabetes and treated with oral antihyperglycemic agents or insulin prior to cardiac MRI, will be performed as a secondary efficacy parameter|4 months|||||||
1405426|NCT01217307|Secondary|Glycometabolic State|measured by oral glucose tolerance testing and Glycated Hemoglobin according to current criteria|4 months and long-term follow-up|||||||
1405427|NCT01217307|Secondary|Diastolic Function|echocardiographic analysis of diastolic function|4 months|||||||
1405428|NCT01217307|Secondary|Myocardial Infarct Size and Transmural Extent of Infarction as Measured With Cardiac Magnetic Resonance Imaging|myocardial infarct size and transmural extent of infarction will be measured using Late Gadolinium Enhancement cardiac magnetic imaging|4 months after hospitalization|||||||
1405429|NCT01217307|Secondary|Markers of Heart Failure and Glycometabolic State|markers of heart failure: neurohormones (e.g. NT-proBNP), renal function (e.g. MDRD); glycometabolic state: e.g. HbA1c.|4 months and longterm follow-up|||||||
1405430|NCT01217307|Secondary|the Incidence of a Cardiovascular Event|Cardiovascular events include major cardiac adverse events (MACE; death, recurrent MI, target lesion revascularization), stroke, non-elective hospitalizations for chest pain or heart failure, all recurrent coronary interventions, and internal cardiac defibrillator implantations. Mortality will be divided into cardiac and non-cardiac. Cardiac death will be divided into three categories: heart failure, sudden death and other. A cardiologist will confirm deaths from cardiovascular causes by examining medical records obtained from hospitals and attending physicians or from attending general practitioner if the patient died at home.|4 months and longterm follow-up|||||||
1405431|NCT01217307|Primary|Improvement in Left Ventricular Ejection Fraction|The primary efficacy parameter of the GIPS-III trial is LVEF measured by cardiac MRI 4 months after randomization, based on an intention-to-treat analysis. It is hypothesized that metformin therapy will result in a higher ejection fraction after 4 months.|4 months|patients undergoing primary percutaneous coronary intervention (PCI) for STEMI|||% of LVEF||95% Confidence Interval|Mean
1405432|NCT01217229|Secondary|Pharmacodynamic Biomarkers|Blood samples for serum CSF-1, IL-34 and biomarkers of Fms inhibiton and Hodgkin Lymphoma activity will be obtained from subjects and analyzed for changes in activity.|1 year|||||||
1405433|NCT01217229|Secondary|Progression Free Survival|Subjects will be monitored for disease progression with contrast CT/18FDG-PET scans every two cycles. One cycle is 28 days.|1 Year|||||||
1405434|NCT01217229|Primary|Disease Response Using Cheson Criteria|Subjects will be monitored for response and disease progression with contrast CT/18FDG-PET scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria will be reported via descriptive statistics. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.|1 year|By protocol|||Response|||Number
1405435|NCT01217112|Secondary|The Change From Baseline in Mean Beck Depression Inventory-II (BDI-II) Score at the End of 91 Days (13 Weeks) of Treatment|The BDI-II is a 21 question, multiple choice, self-reported inventory, and is one of the most widely used instruments for measuring the severity of depression. The 21 questions or items each had four possible responses. Each response was assigned a score ranging from zero to three, indicating the severity of the symptom, with a total possible score ranging from zero to 63. A score between zero and 13 indicates ‘minimal depression’. A score between 14 and 19 indicates ‘mild depression’. A score between 20 and 28 indicates ‘moderate depression’, and a score between 29 and 63 indicates ‘severe depression’. As such, an increase from baseline to the end of treatment, a positive value, indicates a deterioration.|Baseline (Day 1) and the End of Treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1405436|NCT01217112|Secondary|Adverse Events as a Measure of Patient Safety|The incidence of treatment-emergent adverse events was recorded for the study duration, and the number of patients who experienced an adverse event is presented.|Day 1 - Day 92|All correctly randomised subjects who received at least one dose of study treatment were included and analysed according to the treatment received.|||participants|||Number
1405437|NCT01217112|Secondary|The Change From Baseline in Mean Appetite 0-10 Numerical Rating Scale Score After 91 Days (13 Weeks) of Treatment|Subjects scored their appetite daily using an appetite 0-10 numerical rating scale score where 0 = no appetite (don't feel hungry) and 10 = maximum appetite (completely hungry all the time). The mean change from baseline to the end of treatment in scores were calculated. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1405438|NCT01217112|Secondary|The Change From Baseline in Mean % Liver Fat After 91 Days (13 Weeks) of Treatment|Percentage liver fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent liver fat||Standard Deviation|Mean
1405439|NCT01217112|Secondary|The Change From Baseline in Mean Abdominal Adiposity After 91 Days (13 Weeks) of Treatment|Abdominal Adiposity was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405440|NCT01217112|Secondary|The Change From Baseline in Mean Total Fat After 91 Days (13 Weeks) of Treatment|Total Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405441|NCT01217112|Secondary|The Change From Baseline in Mean Total Subcutaneous Fat After 91 Days (13 Weeks) of Treatment|Total Subcutaneous Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405442|NCT01217112|Secondary|The Change From Baseline in Mean Total Internal Fat After 91 Days (13 Weeks) of Treatment|Total Internal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405443|NCT01217112|Secondary|The Change From Baseline in Mean Total Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405444|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405445|NCT01217112|Secondary|The Change From Baseline in Mean Internal Non-Abdominal Fat After 91 Days (13 Weeks) of Treatment|Internal Non-Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scan were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405446|NCT01217112|Secondary|The Change From Baseline in Mean Total Abdominal Fat After 91 Days (13 Weeks) of Treatment|Total Abdominal Fat was measured by magnetic resonance imaging, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405447|NCT01217112|Secondary|The Change From Baseline in Mean Subcutaneous Abdominal Fat After 91 Days (13 Weeks) of Treatment|Subcutaneous Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405448|NCT01217112|Secondary|The Change From Baseline in Mean Visceral Abdominal Fat After 91 Days (13 Weeks) of Treatment|Visceral Abdominal Fat was measured by magnetic resonance imaging at baseline and the end of treatment, and the results of the scans were analysed blind by a single independent reviewer. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||litres||Standard Deviation|Mean
1405449|NCT01217112|Secondary|The Change From Baseline in Mean Hip Measurement After 91 Days (13 Weeks) of Treatment|Subjects' hip measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||cm||Standard Deviation|Mean
1405515|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|2 weeks|||||||
1405450|NCT01217112|Secondary|The Change From Baseline in Mean Waist Measurement After 91 Days (13 Weeks) of Treatment|Subjects' waist measurements were taken at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||cm||Standard Deviation|Mean
1405451|NCT01217112|Secondary|The Change From Baseline in Mean Body Weight After 91 Days (13 Weeks) of Treatment|Subject's body weights were measured at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||kg||Standard Deviation|Mean
1405452|NCT01217112|Secondary|The Change From Baseline in Mean Waist-to-hip Ratio After 91 Days (13 Weeks) of Treatment|Subject's waist-to-hip ratios were calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
1405453|NCT01217112|Secondary|The Change From Baseline in Mean Body Mass Index After 91 Days (13 Weeks) of Treatment|Body Mass Index was calculated at baseline and the end of treatment. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||kg/m^2||Standard Deviation|Mean
1405454|NCT01217112|Secondary|The Change From Baseline in Mean Insulin B Cell Function Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin B Cell Function were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate beta cell function (%B) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent beta function||Standard Deviation|Mean
1405455|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Sensitivity Measured by Homeostasis Model Assessment 2 (HOMA2) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin sensitivity were calculated by HOMA2. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent sensitivity||Standard Deviation|Mean
1405456|NCT01217112|Secondary|The Change From Baseline in Mean Insulin Resistance Measured by Homeostasis Model Assessment 2 (HOMA2-IR) After 91 Days (13 Weeks) of Treatment|Changes from baseline to the end of treatment in mean insulin resistance were calculated by HOMA2-IR. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance, which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||IR score||Standard Deviation|Mean
1405457|NCT01217112|Secondary|The Change From Baseline in Mean C-peptide Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of C-peptide concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||nmol/l||Standard Deviation|Mean
1405458|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Insulin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting insulin concentrations. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||pmol/l||Standard Deviation|Mean
1405459|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Insulin Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test)|At baseline and the end of treatment, blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum insulin levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. An increase in the elevation of serum insulin levels from baseline to the end of treatment (i.e. a positive value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||pmol/l||Standard Deviation|Mean
1405471|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
1405516|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|2 weeks|||||||
1405517|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|2 weeks|||||||
1405460|NCT01217112|Secondary|The Change From Baseline to the End of 91 Days (13 Weeks) of Treatment in the Mean Serum Glucose Concentration Two Hours Post Glucose Challenge (Oral Glucose Tolerance Test [OGTT])|A two-hour OGTT was performed to investigate the rate of glucose metabolism or clearance from the blood with treatment. Blood samples were taken at -15 and 0 minutes prior to a glucose drink and at 30, 60, 90, 120 and 180 minutes post drink. The OGTT measured the change from baseline in serum glucose levels at two hours (120 minutes) compared to 0 minutes. The extent of the elevation in blood glucose levels following a glucose drink were compared between baseline and the end of treatment. A reduction in the elevation of serum glucose levels at the end of treatment (i.e. a negative value) indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405461|NCT01217112|Secondary|The Change From Baseline in Mean Glycated Haemoglobin Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of glycated haemoglobin concentrations. At both time points, values were calculated as a percentage of total haemoglobin. A decrease from baseline to the end of treatment in base per cent values, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||percent||Standard Deviation|Mean
1405462|NCT01217112|Secondary|The Change From Baseline in Mean Fructosamine Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fructosamine concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||umol/l||Standard Deviation|Mean
1405463|NCT01217112|Secondary|The Change From Baseline in Mean Fasting Glucose Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of fasting glucose concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405464|NCT01217112|Secondary|The Change From Baseline in Mean Serum Non-Esterified Fatty Acid Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Non-Esterified Fatty Acid concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405465|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B : Apolipoprotein A Ratio After 91 Days (13 Weeks) of Treatment|A decrease from baseline to the end of treatment (i.e. a negative value) in the Apolipoprotein B : Apolipoprotein A ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
1405466|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein B Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein B. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||umol/l||Standard Deviation|Mean
1405467|NCT01217112|Secondary|The Change From Baseline in Mean Serum Apolipoprotein A Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Apolipoprotein A. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||umol/l||Standard Deviation|Mean
1405468|NCT01217112|Secondary|The Change From Baseline in Mean Triglyceride Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of triglyceride concentrations by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405469|NCT01217112|Secondary|The Change From Baseline in Mean Serum Triglyceride Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum triglyceride concentrations. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405470|NCT01217112|Secondary|The Change From Baseline in Mean Very Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Very Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405495|NCT01216748|Primary|Changes in Airway Blood Flow After 180μg Albuterol by Inhalation (ΔQaw) vs Baseline|Effect of airway pH on albuterol responsiveness as reflected by the change in airway blood flow after 180μg albuterol by inhalation (ΔQaw) vs baseline.|15 minutes after albuterol inhalation||||changes from baseline in μl.min-1.ml-1||Standard Error|Mean
1405472|NCT01217112|Secondary|The Change From Baseline in Mean Serum High Density Lipoprotein : Low Density Lipoprotein Cholesterol Ratio After 91 Days (13 Weeks) of Treatment|An increase from baseline (i.e. a positive value) to the end of treatment in the High Density Lipoprotein : Low Density Lipoprotein cholesterol ratio indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||ratio||Standard Deviation|Mean
1405473|NCT01217112|Secondary|The Change From Baseline in Mean Low Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of Low Density Lipoprotein cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405474|NCT01217112|Secondary|The Change From Baseline in Mean Serum Low Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum Low Density Lipoprotein cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405475|NCT01217112|Secondary|The Change From Baseline in Mean Total Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol by ultracentrifugation. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405476|NCT01217112|Secondary|The Change From Baseline in Mean Serum Total Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum total cholesterol. A decrease from baseline to the end of treatment, a negative value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405477|NCT01217112|Secondary|The Change From Baseline in Mean High Density Lipoprotein Cholesterol Concentration by Ultracentrifugation After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of High Density Lipoprotein cholesterol by ultracentrifugation. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405478|NCT01217112|Primary|The Change From Baseline in Mean Serum High Density Lipoprotein Cholesterol Concentration After 91 Days (13 Weeks) of Treatment|At baseline and the end of treatment, an approximately 30 mL fasting blood sample was taken for measurement of serum High Density Lipoprotein cholesterol. An increase from baseline to the end of treatment, a positive value, indicates an improvement.|Baseline (Day 1) and End of treatment (Day 92)|The analysis population comprised all randomised subjects who received at least one dose of study medication and had on-treatment efficacy data.|||mmol/l||Standard Deviation|Mean
1405479|NCT01217073|Secondary|Change From Baseline in FPG Levels at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1405480|NCT01217073|Secondary|Mean FPG Level at Baseline of the Extension Period|Plasma FPG levels were measured at baseline (Week 0) for particiapnts who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available FPG baseline data.|||mg/dL||Standard Deviation|Mean
1405481|NCT01217073|Secondary|Change From Baseline in 2h-PMG at Week 78|Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1405482|NCT01217073|Secondary|Mean 2h-PMG Level at Baseline of the Extension Period|Plasma 2h-PMG levels were measured at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available 2h-PMG baseline data.|||mg/dL||Standard Deviation|Mean
1405483|NCT01217073|Secondary|Change From Baseline in Plasma A1C Levels at Week 78|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 78 level.|Baseline (Week 0) and Week 78|Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
1405484|NCT01217073|Secondary|Mean Plasma A1C Level at Baseline of the Extension Period|A1C levels were measured as a percent at baseline (Week 0) for participants who entered the extension period.|Baseline (Week 0)|All participants who entered the extension period of the study with available A1C baseline data.|||Percent||Standard Deviation|Mean
1405496|NCT01216735|Secondary|Flow-mediated Brachial Vasodilation (FMD% Peak Delta)|Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation|3 weeks of treatment||||% change||Standard Error|Mean
1405485|NCT01217073|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1405486|NCT01217073|Secondary|Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12|Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
1405487|NCT01217073|Primary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 66 weeks (Weeks 12 to 78)|Analysis population defined as all randomized participants who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.|||Percentage of participants|||Number
1405488|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period)|Analysis population defined as all randomized participamts who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.|||Percentage of participants|||Number
1405489|NCT01217073|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 12 weeks|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.|||Percentage of participants|||Number
1405490|NCT01217073|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.|Up to 16 weeks (including 28 days following the last dose of study drug)|The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.|||Percentage of participants|||Number
1405491|NCT01217073|Primary|Change From Baseline in Plasma A1C Levels at Week 12|A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.|Baseline (Week 0) and Week 12|Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
1405492|NCT01216943|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1405493|NCT01216761|Primary|Blood Culture Contamination|A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites.|5 days|Intention to treat analyses. Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.|||blood culture sets|Blood culture sets||Number
1405494|NCT01216748|Secondary|Exhaled Breath Condensate (EBC) pH Variation|"EBC samples were collected at each respiratory maneuver by directing the subject's exhaled breath into a pre-cooled (-10C) tube for 10 min.~pH was measured immediately after collection."|10 minutes after each respiratory manouver.||||pH||Standard Error|Mean
1405518|NCT01216631|Primary|Ultrasound Synovitis Score|reduction of ultrasound synovitis score of the affected knee at 8 weeks following intiation of treatment|8 weeks|Only one patient was recruited for this study due to problems with recruitment. Therefore outcome measure data is not analysed as only one patient was recruited.||||||
1405519|NCT01216410|Secondary|Maternal Hemodynamics|The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively|Intraoperatively||||participants with SBP< 20 % baseline|||Number
1405520|NCT01216410|Secondary|Satisfaction|1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted.|24 h||||participants|||Number
1405521|NCT01216410|Secondary|Pruritus||0-24 hrs||||participants|||Number
1405522|NCT01216410|Secondary|Postoperative Nausea and Vomiting (PONV)||0-2h, 2-6h, 6-24h||||participants|||Number
1405523|NCT01216410|Primary|Intraoperative Nausea and Vomiting|Comparison of intraoperative nausea and vomiting between the 3 groups.|Intraoperatively||||participants|||Number
1405524|NCT01216397|Secondary|Assessment of Tolerability by the Investigator|Qualitative variable assessing the tolerability by the investigator|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
1405525|NCT01216397|Secondary|Participants Who Discontinued the Trial Because of an Adverse Event|Number of participants who discontinued the trial because of an adverse event|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
1405526|NCT01216397|Secondary|Participants With Treatment Emergent Adverse Events|Number of patients with treatment emergent AEs|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
1405527|NCT01216397|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|Day 1 to 4 for period 1, and day 36 to 39 for period 2|Treated Set|||Participants|||Number
1405528|NCT01216397|Secondary|Metformin: Vz/F|Geometric mean of Vz/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||Liter||Geometric Coefficient of Variation|Geometric Mean
1405529|NCT01216397|Secondary|Metformin: CL/F|Geometric mean of CL/F of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1405530|NCT01216397|Secondary|Metformin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of MRTpo of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
1405531|NCT01216397|Secondary|Metformin: t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of t1/2 of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
1405532|NCT01216397|Secondary|Metformin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of λz of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1405533|NCT01216397|Secondary|Metformin: Tmax|Median of tmax of metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Full Range|Median
1405534|NCT01216397|Secondary|Metformin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of the percentage of AUCtz-infinity of Metformin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||percentage||Geometric Coefficient of Variation|Geometric Mean
1405535|NCT01216397|Secondary|Metformin: AUC0-infinity|Geometric Mean of AUC0-infinity of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1405536|NCT01216397|Primary|Metformin: AUC0-tz|Geometric Mean of AUC0-tz of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1405537|NCT01216397|Primary|Metformin: Cmax|Geometric Mean of Cmax of Metformin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405538|NCT01216397|Secondary|Linagliptin: Apparent Volume of Distribution During the Terminal Phase Following an Extravascular Dose (Vz/F)|Geometric mean of the Vz/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||Liter||Geometric Coefficient of Variation|Geometric Mean
1405539|NCT01216397|Secondary|Linagliptin: Apparent Clearance of the Analyte in Plasma After Extravascular Administration (CL/F)|Geometric mean of the CL/F of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1405540|NCT01216397|Secondary|Linagliptin: MRTpo (Mean Residence Time of the Analyte in the Body After Peroral Administration)|Geometric mean of the MRTpo of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
1405541|NCT01216397|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma)|Geometric mean of the t1/2 of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Geometric Coefficient of Variation|Geometric Mean
1405542|NCT01216397|Secondary|Linagliptin: λz (Terminal Elimination Rate Constant in Plasma)|Geometric mean of the λ_z of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||1/hr||Geometric Coefficient of Variation|Geometric Mean
1405543|NCT01216397|Secondary|Linagliptin: Time to Maximum Measured Concentration of the Analyte in Plasma (Tmax)|Median of the t_max of linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||hr||Full Range|Median
1405544|NCT01216397|Secondary|Linagliptin: Percentage of AUCtz-∞ Obtained by Extrapolation|Geometric Mean of percentage of AUCtz-∞ of linagliptin, where percentage is the unit of measurement.|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||percentage||Geometric Coefficient of Variation|Geometric Mean
1405545|NCT01216397|Secondary|Linagliptin: AUC0-infinity|Geometric mean of AUC0-infinity of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
1405546|NCT01216397|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)|Geometric mean of AUC0-72 of Linagliptin|Day 1 to 35 for period 1, and Day 36 to 70 for period 2|Treated Set|||nmol*hr/L||Geometric Coefficient of Variation|Geometric Mean
1405549|NCT01216319|Primary|Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)||12 months|There were two patients (three nipples) without plastic surgery matrix in place at 12MO.|||percentage of projection vs baseline|Participants|Standard Deviation|Mean
1405550|NCT01216241|Primary|Percentage of Afebrile Neutropenic Subjects|To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.|5 days||||participants|||Number
1405551|NCT01216163|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405552|NCT01216163|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1405553|NCT01216163|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1405554|NCT01216163|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||hours||95% Confidence Interval|Median
1405555|NCT01216163|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1405556|NCT01216163|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled ‘meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
1405557|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405558|NCT01216163|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405559|NCT01216163|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best).|0 to 2, 0 to 3, 0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405560|NCT01216163|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405561|NCT01216163|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405608|NCT01215942|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores||Baseline, 240 weeks|Zero participants analyzed. SF-36 data was not collected for analysis due to early termination of the study.||||||
1405562|NCT01216163|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405563|NCT01216163|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1405564|NCT01216163|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 6 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
1405565|NCT01216163|Primary|Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
1405566|NCT01216072|Secondary|Physician-reported Clinical Global Impression of Improvement (CGI-I)|The CGI-I is a rating scale allowing a physician-reported global evaluation of the subject's improvement over time. The Investigator assessed the subject's clinical change relative to the symptoms at baseline on the CGI-I, a seven-point scale, with rating as follows: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. The assessments were completed at Month 3 and Month 6. A lower score indicates improvement.|Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with month 3 and month 6 assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1405567|NCT01216072|Secondary|Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory. Each item is scored from 0 to 3. The questions in the BDI-II refer to how the patient has been feeling over the past two weeks specifically. The BDI-II total score was calculated by summing the 21 item scores. Final scores ranged from 0 to 63 where higher scores indicated more severe depression. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
1405568|NCT01216072|Secondary|Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1405569|NCT01216072|Secondary|Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4|The convenience subscale was scored as follows: questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and question 11 scored as 1(extremely inconvenient) to 7 (extremely convenient). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
1405590|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in 1,5-anhydroglucitol (1,5-AG)|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline 1,5-AG value, except participants from the excluded site.|||microgram/milliliter (mcg/mL)||Standard Error|Least Squares Mean
1405570|NCT01216072|Secondary|Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4|The Side Effects subscale was scored as follows: question 4 scored as 0(no) or 1(yes); question 5 scored as 1(extremely bothersome) to 5(not at all bothersome); and questions 6 - 8 scored as 1(a great deal) to 5(not at all). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
1405571|NCT01216072|Secondary|Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4|The effectiveness scale was scored as follows: 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
1405572|NCT01216072|Secondary|Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)|The Fatigue Severity Scale (FSS) is a 9-item assessment scale measuring fatigue and its effects, using a scale from 1 to 7, with higher scores indicating greater fatigue, or greater negative effects of fatigue on daily living. The FSS 9 item total score was calculated by summing the first 9 item scores and dividing by the number of non-missing items. If no more than 20% of the items were missing, the total score was the product of the mean response of the non missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 3, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with baseline to 3 month assessments and/or baseline to 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
1405573|NCT01216072|Secondary|Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6|The PRIMUS activity measure is a 15-item assessment of patient-reported ADL. The PRIMUS-Activities total score was calculated by summing the 15 item scores after recoding the responses from 1 - 3 to 0 - 2. Totals scores range from 0 to 30 with higher scores indicating greater activity limitation. If no more than 20% of the items were missing, the total score was the product of the mean response of the non-missing items and the total number of items. If more than 20% of all items were missing, the total score was set to missing. A negative change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1405574|NCT01216072|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|In this analysis, patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.|9 months (6 month core + 3 month Extension)|Safety Set included all patients who received at least one dose of study drug.|||Participants|||Number
1405575|NCT01216072|Primary|Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6|The TSQM was developed and validated as a general measure for treatment satisfaction. It contains 14 items assessing the following 4 domains: effectiveness (sum of scores for questions 1 - 3), side effects (sum of scores for questions 4 - 8), convenience (sum of scores for questions 9 - 11) and Global Satisfaction (sum of scores for questions 12 - 14). The primary analysis was on Global Satisfaction. Question 12 scored as 1(not at all confident) to 5 (extremely confident); question 13 scored as 1(not at all certain) to 5(extremely certain); and question 14 scored as 1(extremely dissatisfied) to 7(extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction. A positive change from baseline indicates improvement.|Baseline, Month 6|This analysis was conducted using the Full Analysis Set. The Full Analysis Set comprised all randomized patients to whom study medication was assigned. Patients with both baseline and 6 month assessments were included in this analysis.|||units on a scale||Standard Deviation|Mean
1405576|NCT01215981|Secondary|Number of Subjects With H3 Based Immune Response to Vaccine|The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.|||Patients|||Number
1405577|NCT01215981|Primary|Number of Subjects With T-Cell Based Immune Response to Vaccine|The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.|8 Weeks After Vaccination|One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation.|||Patients|||Number
1405578|NCT01215968|Secondary|Number of Participants With Clinically Significant Effects|Adverse events (AEs) were considered clinically significant effects. A summary of serious adverse events (SAEs) and other nonserious AEs are located in the Reported Adverse Event section.|Baseline through 5 weeks|All enrolled participants who received at least one dose of study drug.|||participants|||Number
1405579|NCT01215968|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Tmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.|||hour||Full Range|Median
1405580|NCT01215968|Secondary|Maximum Concentration (Cmax) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Cmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had pharmacokinetic (PK) data. Those who violated protocol were excluded.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1405581|NCT01215968|Secondary|Area Under the Curve (AUC) of Metformin|Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as AUC) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying. AUC of metformin was calculated during one dosing interval.|Days 3, 17 and 31|All randomized participants who received both study drug and immediate release metformin, and had PK data. Those who violated protocol were excluded.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1405582|NCT01215968|Primary|Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy|After at least 8 hours fasting, participants received a radiolabeled breakfast containing technetium-99m-tin colloid (99mTc-tin colloid). After which serial anterior and posterior scintigraphy images were taken. Data presented are the time required for 50% of radioactivity to be emptied from stomach. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for weeks.|Days 3, 10,17, 24 and 31|All randomized participants who received study drug, a radiolabeled breakfast, and had scintigraphy images taken. Those who violated protocol were excluded.|||hours||90% Confidence Interval|Geometric Mean
1405583|NCT01215955|Secondary|Percentage of Participants With Severe Hypoglycemic Episodes|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by low plasma glucose.|Randomization up to 24 weeks|All randomized participants except those from the excluded site.|||percentage of participants|||Number
1405584|NCT01215955|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of hypoglycemic episodes reported divided by the number of days at risk times 30.|Randomization through 24 weeks overall|All randomized participants except those from the excluded site.|||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
1405585|NCT01215955|Secondary|The Number of Participants ≥65 Years of Age With Hypoglycemic Episodes (Incidence)|A hypoglycemic episode in participants ≥ 65 years of age was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants ≥65 years old except those from the excluded site.|||participants|||Number
1405586|NCT01215955|Secondary|The Number of Participants With a Hypoglycemic Episode (Incidence)|A hypoglycemic episode was defined as any time a participant felt they were experiencing a sign or symptom that was associated with hypoglycemia, or had a blood glucose level of ≤70 milligram per deciliter [mg/dL, ≤3.9 millimoles per liter (mmol/L)] even if it was not associated with signs, symptoms or treatment (consistent with current American Diabetes Association 2005 guidelines).|Randomization through 24 weeks overall|All randomized participants except from the excluded site.|||participants|||Number
1405587|NCT01215955|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Total, basal and prandial amounts were then divided by the participant's body weight in kilograms (kg). Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.|||international units/kilogram (IU/kg)||Standard Error|Least Squares Mean
1405588|NCT01215955|Secondary|Daily Dose of Insulin: Total, Basal and Prandial (Bolus)|Total insulin was the sum of basal insulin (glargine) that was required to manage normal daily blood fluctuations and prandial insulin that was taken at meal time. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and with values in the specified category, except participants from the excluded site.|||international units (IU)||Standard Error|Least Squares Mean
1405589|NCT01215955|Secondary|Change From Baseline to 24 Weeks in 7-Point Self-Monitored Blood Glucose (SMBG) Profile|7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 time a day at the morning pre-meal, morning 2-hours (HR) postprandial (PP), midday pre-meal, midday 2-hours post-meal, evening pre-meal, bedtime and 0300 hour (3 am). Each participant took measures over any 3 days and the average was calculated for each of the 7 time points. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and had values at baseline and the specified timepoint, except participants from the excluded site.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1405630|NCT01215695|Secondary|The Number of Intubation Attempts|counted as each approach of the ETT to the glottic entrance.|30 minutes||||Number of intubation attempts||Standard Deviation|Mean
1405591|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose in Participants ≥65 Years of Age|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, who are ≥65 years of age with baseline fasting glucose values, except participants from the excluded site.|||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
1405592|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Fasting Glucose|Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction.|Baseline, 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with baseline fasting glucose values, except participants from the excluded site.|||millimoles/liter (mmoles/L)||Standard Error|Least Squares Mean
1405593|NCT01215955|Secondary|Time to Reach Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants is the number of participants who achieved HbA1c target values of ≤6.5% or ≤7.0% during the specified time period divided by the total number of participants who did not discontinue from the study but had not reached HbA1c target at the beginning of the specified post baseline time period (≤100 days and ≥101 days). Participants who did not experience an outcome before discontinuation or completion of the study were censored using the date of discontinuation. Participants who were lost to follow up the date of discontinuation were considered to be the date of last contact.|Baseline through 24 weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site. Censored participants: Study A: ≤6.5% Q1D=186 and Q3D=197; Study A ≤7.0% Q1D=120 and Q3D=134; Study B: ≤6.5% Q1D=206 and Q3D=212, Study B ≤7.0% Q1D=135 and Q3D=152.|||percentage of participants|||Number
1405594|NCT01215955|Secondary|Change From Baseline to 24 Week Endpoint in Body Weight|Body weight was measured twice at each indicated visit and the average of the 2 measurements was used for analyses. Least Squares (LS) mean calculated using mixed model repeating measure (MMRM) analysis that included baseline, treatment, country, sulfonylurea/meglitinide use, baseline glycated hemoglobin (HbA1c) strata (≤8% and >8%), visit and treatment-by-visit interaction .|Baseline, 24-weeks|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized and received ≥1 dose of study insulin with a baseline body weight, except participants from the excluded site.|||kilograms (kg)||Standard Error|Least Squares Mean
1405595|NCT01215955|Secondary|Percentage of Participants ≥65 Years of Age Achieving Glycated Hemoglobin (HbA1c) Target Concentration|Percentage of participants ≥65 years of age achieving HbA1c target concentration of ≤7.0% or ≤6.5%.|24-week endpoint|A subset of the Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin and were ≥65 years of age, except participants from the excluded site. Last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1405596|NCT01215955|Secondary|Percentage of Participants Achieving Glycated Hemoglobin (HbA1c) Target Values|Percentage of participants who achieved HbA1c levels of ≤7.0% or ≤6.5%.|24-week endpoint|Full Analysis Set: all participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin, except participants from the excluded site; last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1405597|NCT01215955|Primary|Change From Baseline to 24 Week Endpoint in Glycated Hemoglobin (HbA1c)|The change from baseline to 24 weeks in the percentage of HbA1c in plasma. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: fixed effects for treatment, country, sulfonylurea/meglitinide use, visit, treatment by visit interaction with baseline HbA1c as a covariate.|Baseline, 24 weeks|Full Analysis Set: All participants who completed the lead-in period (if applicable), were randomized, received ≥1 dose of study insulin with a baseline value for HbA1C, except participants from the excluded site.|||percentage HbA1c||Standard Error|Least Squares Mean
1405598|NCT01215942|Primary|Change From Baseline in Serum Immunoglobulin (Ig) Levels|Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.|Baseline, Week 48|All participants from Studies BCDO and BCDV with an evaluable serum Ig data. LOCF was used to impute missing post-baseline values.|||grams/liter (g/L)||Standard Deviation|Mean
1405599|NCT01215942|Other Pre-specified|Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period||Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period|All enrolled participants.|||Participants|||Count of Participants
1405600|NCT01215942|Secondary|American College of Rheumatology Percent Improvement (ACR-N)||Baseline through 240 weeks|Zero participants analyzed. ACR-N data was not collected for analysis due to early termination of the study.||||||
1405601|NCT01215942|Secondary|Change From Baseline in CRP||Baseline, 240 weeks|Zero participants analyzed. CRP data was not collected for analysis due to early termination of the study.||||||
1405602|NCT01215942|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)||Baseline, 240 weeks|Zero participants analyzed. HAQ-DI data was not collected for analysis due to early termination of the study.||||||
1405603|NCT01215942|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)||Baseline, 240 weeks|Zero participants analyzed. Physicians global assessment data was not collected for analysis due to early termination of the study.||||||
1405604|NCT01215942|Secondary|Change From Baseline in Participants Global Assessment of Disease Activity (VAS)||Baseline, 240 weeks|Zero participants analyzed. Participants Global assessment data was not collected for analysis due to early termination of the study.||||||
1405609|NCT01215942|Secondary|Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response||Baseline through 240 weeks|Zero participants analyzed. EULAR-28 data was not collected for analysis due to early termination of the study.||||||
1405610|NCT01215942|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)||Baseline, 240 weeks|Zero participants analyzed. DAS28-CRP data was not collected for analysis due to early termination of the study.||||||
1405611|NCT01215942|Secondary|Percentage of Participants With American College of Rheumatology 20% Response (ACR20)|ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.|Baseline through Weeks 12, 24 and 48|All participants from Studies BCDO and BCDV with an evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR20 was missing after carrying forward CRP, last post-baseline ACR20 response was used.|||percentage of participants|||Number
1405612|NCT01215942|Primary|Change From Baseline in Absolute B Cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.|Baseline, Week 48|All participants from Studies BCDO and BCDV with an evaluable CD3-CD20+ B cell counts. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||cells/microliter (cells/µL)||Standard Deviation|Mean
1405613|NCT01215942|Primary|Percentage of Participants Developing Anti-LY2127399 Antibodies|Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.|Baseline through Weeks 4, 24, 48 and 72|All participants from Studies BCDO and BCDV with an evaluable baseline anti-LY2127399 antibodies result and a post-baseline anti-LY2127399 antibodies result. Participants missing an evaluable baseline result with a negative post-baseline results were included.|||percentage of participants|||Number
1405614|NCT01215942|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period|A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|up to 84.4 weeks during treatment period|All enrolled participants.|||Participants|||Count of Participants
1405615|NCT01215929|Primary|Measure of Methamphetamine Withdrawal|Total score on the Methamphetamine Withdrawal Assessment scale (MAWA) based on DSMIV criteria for amphetamine withdrawal. This questionnaire is comprised of 13 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score indicating no methamphetamine withdrawal symptoms is 0 and the maximum score is 4 indicating that a patient has the most severe withdrawal symptom related to that question. The subscales are the 13 questions and the total score is the sum of all the scores for the 13 items on the scale. The range minium and better outcome is a lower score. The range is from 0-52. The worse outcome is reflected in a higher score.|at the end of week 4||||units on a scale||Standard Error|Least Squares Mean
1405616|NCT01215851|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (TTP versus Day).|14 Days|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 81.|||time (h) to positive per day||Standard Deviation|Mean
1405617|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 7-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.|||log10CFU/ml/day||Standard Deviation|Mean
1405618|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 2-14|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this measure was 80.|||log10CFU/ml/day||Standard Deviation|Mean
1405619|NCT01215851|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|Day 0-2|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number patients analyzed for this measure was 84.|||log10CFU/ml/day||Standard Deviation|Mean
1405620|NCT01215851|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).|Log10 CFU rates of change were calculated for each individual patient from the slopes β1 and β2 of the bi-linear regression fitted to the data for each individual patient (log10CFU versus Day). Mean log10 CFU changes from baseline were compared. A higher slope value indicates a greater change in log10 CFU from baseline. Note that to facilitate interpretation the sign of these slopes are reversed for logCFU. A positive slope value therefore indicates a reduction in log10 CFU from baseline.|14 consecutive days of treatment|In the case of patient dropout, their patient data were included in the analyses as long as enough points were recorded to allow curve fitting. The number of patients analyzed for this outcome was 80.|||log10CFU/ml/day||Standard Deviation|Mean
1405621|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 14|Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 14|The analysis population included all patients that started the study and were treated with AGN-207281.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
1405622|NCT01215786|Secondary|Mean Concentration of AGN-207281 in Plasma at Day 7|Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.|Day 7|The analysis population included all patients that started the study and were treated with AGN-207281.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
1405623|NCT01215786|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14|Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Day 14|Safety population, which consisted of all patients who started the study and received treatment.|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
1405624|NCT01215734|Secondary|Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses|Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus|Before TIV and 28-42 days after TIV|Patients who received either the high-dose or the standard dose TIV and who had blood drawn for HAI titers before TIV and at 28-42 days after TIV. Data not available for 5 HD and 1 SD patients.|||participants|||Number
1405625|NCT01215734|Primary|Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients|Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.|Day of TIV to 7 days after TIV|Patients who received either the high-dose TIV or the standard dose TIV|||participants|||Number
1405626|NCT01215721|Primary|Time to Continence|Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.|12 months||||Days to Continence||Standard Deviation|Median
1405627|NCT01215695|Secondary|Ease of Intubation|After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.|2-4 hours after intubation||||units on a scale||Standard Deviation|Mean
1405628|NCT01215695|Secondary|Laryngeal View Grade of 1 or 2|The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).|30 minutes||||Participants|||Count of Participants
1405629|NCT01215695|Secondary|Neck Movement|One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.|30 minutes|Only those participants with available data were analyzed for the assessment. All subjects reported had mild, moderate or severe neck movement.|||Participants|||Count of Participants
1405631|NCT01215695|Primary|Intubation Time|divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.|120 seconds||||time in seconds||Inter-Quartile Range|Median
1405632|NCT01215643|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (< LOD) during treatment.|within 24 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
1405633|NCT01215643|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"Viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOD) during treatment"|within 24 weeks of treatment|Full Analysis Set|||percentage of participants|||Number
1405634|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
1405635|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)||24 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
1405636|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)||24 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
1405637|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
1405638|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)||12 weeks after the end of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
1405639|NCT01215643|Secondary|Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)|SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.|12 weeks after the end of treatment|Full Analysis Set|||percentage of participants|||Number
1405640|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
1405641|NCT01215643|Secondary|Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)||at end of treatment, within 24 weeks|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
1405642|NCT01215643|Secondary|Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)|ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.|at end of treatment, within 24 weeks|Full Analysis Set|||percentage of participants|||Number
1405643|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
1405644|NCT01215643|Secondary|Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)||after 12 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
1405645|NCT01215643|Secondary|Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)|cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.|after 12 weeks of treatment|Full Analysis Set|||percentage of participants|||Number
1405646|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 3 HCV infection|||percentage of participants|||Number
1405647|NCT01215643|Secondary|Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)||after 4 weeks of treatment|Participants in the Full Analysis Set with genotype 2 HCV infection|||percentage of participants|||Number
1405648|NCT01215643|Secondary|Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)|RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set|||percentage of participants|||Number
1405649|NCT01215643|Primary|Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)|RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.|after 4 weeks of treatment|Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.|||percentage of participants|||Number
1405650|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in ECG Variables|This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).|||Participants|||Number
1405651|NCT01215513|Secondary|Serum Levels of Prostate Specific Antigen (PSA) Over Time|PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).|Day 0, day 196, day 280, and day 364|CS42 and CS42A full analysis set (data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing). The figures present the median of the absolute values at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).|||ng/mL||Full Range|Median
1405652|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).|||Participants|||Number
1405653|NCT01215513|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|"The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one participant with abnormal value are presented, more variables were included in the study.~ULN=upper limit of normal"|From baseline (day 0) to end of treatment (up to day 364)|Descriptive statistics provided a view of the 1-year safety of degarelix (CS42 and CS42A safety analysis set).|||Participants|||Number
1405654|NCT01215435|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.|Week 0 to Week 36|Safety analysis set includes all subjects who received at least one dose of the trial product.|||episodes|||Number
1405655|NCT01215435|Secondary|Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 weeks of treatment|Week 0, Week 36|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
1405656|NCT01215435|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11|Estimated mean change from baseline in HbA1c after 11 weeks of treatment|Week 0, Week 11|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using baseline observation carried forward (BOCF)|||percentage of glycosylated haemoglobin||Standard Error|Mean
1405657|NCT01215422|Secondary|"Number of Intubation Attempts to Reach Best Obtainable Time to Intubation"|"For each anesthesiologist, the median time-to-intubation for patients #1-5, #6-10, #11-15, and #16-20 was determined. The anesthesiologist was considered to have reached Best Obtainable Time (BOT) to Intubation once the median time on any group of 5 consecutive patients was less than 3 seconds faster than the median time in the previous group of 5 consecutive patients, provided that there were no failed intubations or subsequent failed intubations using the same device."|less than 5 minutes per intubation||||participants|||Number
1405658|NCT01215422|Secondary|Mean Years Since Completion of Anesthesiology Residency|To investigate whether there was a correlation between the years since completion of anesthesiology residency to the mid-point of study (2008)and median time-to-intubation for all first attempt intubations for the study. Years since completion of anesthesiology residency reported in the data table, correlation reported in the statistical analysis below|Baseline (assessed as of 2008)||||years||Full Range|Mean
1405659|NCT01215422|Secondary|Time to Intubation, Stratified by Weight of Patients|To compare the time-to-intubation for these laryngoscopes in children of different weights.|4 years|Time to Intubation, Stratified by Weight of Patients|||seconds||Standard Deviation|Mean
1405660|NCT01215422|Secondary|Time to Intubation, Analyzed by Order of Laryngoscopes Used|To determine if the learning curve was altered by the order in which the two new laryngoscopes were learned by the anesthesiologist,mean and median times on intubations #16-20 were compared for the two videolaryngoscopes.|4 years|Only anesthesiologists who completed minimum 18 intubations with each scope were included. We report the mean of their mean times and the mean of their median times on intubations #16-20 when they should have attained a reasonable skill level.|||seconds|Participants|Standard Deviation|Mean
1405661|NCT01215422|Secondary|Cormack & Lehane Score|This Outcome was designed to determine if the view of the airway as determined by the Cormack & Lehane grading system is improved by use of the GlideScope (GS) video laryngoscope and/or the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope as this would be a surrogate marker for utility in a difficult airway. Score is reported as a whole number from I to IV with I being an easy intubation and IV being one where the larynx cannot be visualized at all.|reported during intubation (up to 5 minutes)|Patients were excluded if the Cormack-Lehane score was not recorded.|||Percentage of participants|||Number
1405662|NCT01215422|Primary|Success in Learning to Use a Videolaryngoscope(VLS)|"Anesthesiologists were to perform 20 intubations with each videolaryngoscopes. #1-10 were for practice. Rapid Success was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 . Delayed Success was achieving these same parameters on #16-20 if they were not achieved on #11-15. Operators who did not achieve either goal were labeled as having No Success."|Up to 5 minutes per intubation|Only anesthesiologists who completed minimum 18 intubations with either laryngoscope were analyzed for the primary outcome.|||percent of anesthesiologists|Participants||Number
1405663|NCT01215357|Secondary|Effects on the Clinical Global Impression|Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study|6 weeks|||||||
1405664|NCT01215357|Secondary|Statistically Significant Changes in the Gambling Symptom Assessment Scale|It is expected that there will be decreases in this scale|6 weeks|||||||
1405665|NCT01215357|Secondary|Type, Frequency and Severity of Side Effects|All side effects of the drug will be monitored and recorded|6 weeks|||||||
1405666|NCT01215357|Primary|Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling|This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.|Baseline and 6 weeks|Patients completing all visits|||YBOCS score||Standard Deviation|Mean
1405667|NCT01215344|Secondary|Progression Free Survival by MRD Status at Day 100.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 7 years|Patients with MRD status information at the EOI and day 100 (post-AHCT).|||years||95% Confidence Interval|Median
1405668|NCT01215344|Primary|The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).|Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry.|6-months post ASCT|Newly diagnosed, symptomatic multiple myeloma (MM) patients. Patients were treated with induction therapy VRD followed by AHCT. MRD staus was evaluated for patients with at least partial response at the end of induction (EOI) therapy. Ten of these patients had MRD negative at EOI.|||percentage of participants||95% Confidence Interval|Number
1405669|NCT01215292|Primary|Intratesticular Androstenedione (ADD) Level||10 days||||ng/mL||Inter-Quartile Range|Median
1405670|NCT01215292|Primary|Intratesticular Dihydrotestosterone (DHT) Level||10 days||||ng/mL||Inter-Quartile Range|Median
1405671|NCT01215292|Primary|Intratesticular Testosterone (IT-T) Level||10 days||||ng/mL||Inter-Quartile Range|Median
1405672|NCT01215279|Secondary|Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. (Vss/F) was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||L||Full Range|Geometric Mean
1405673|NCT01215279|Secondary|Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||Hours||Full Range|Median
1405674|NCT01215279|Secondary|Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||nmol/L||Full Range|Geometric Mean
1405675|NCT01215279|Secondary|Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State|PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state|2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4||||nmol*h/L||Full Range|Geometric Mean
1405676|NCT01215279|Secondary|SAA Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4||||ng/mL||Full Range|Geometric Mean
1405677|NCT01215279|Secondary|Serum Amyloid-A (SAA) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1||||ng/mL||Full Range|Geometric Mean
1405678|NCT01215279|Secondary|CCL2 Concentration in Plasma at End of Treatment|End of treatment = 4 weeks = Visit 6|week 4||||pg/mL||Full Range|Geometric Mean
1405679|NCT01215279|Secondary|CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline|Baseline = Day 1 = Visit 2|Day 1||||pg/mL||Full Range|Geometric Mean
1405680|NCT01215279|Secondary|SGRQ Total Score at End of Treatment|Decrease in score represents improved Quality of Life; increase represents deteriorated Quality of Life. An increase or decrease of 4 or more percent units is judged as the Minimal Clinically Important Difference.|week 4||||Percent of maximum possible score||Standard Deviation|Mean
1405681|NCT01215279|Secondary|St George’s Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline|The SGRQ-C includes 40 questions in 3 domains: Symptoms (distress due to respiratory symptoms, 7 questions), Activity (disturbance of physical activity, 13 questions), Impacts (overall impact on daily life and well-being, 20 questions). Scores are expressed as a percentage. Baseline is Day 1.|Day 1||||Percent of maximum possible score||Standard Deviation|Mean
1405682|NCT01215279|Secondary|Rescue Medication Use During the Last 7 Days of Treatment|Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day.|Average of the last 7 days of treatment (week 4)||||Inhalations||Full Range|Mean
1405683|NCT01215279|Secondary|BCSS (Evening) Total Score During Last 7 Days of Treatment|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units.|Average of the last 7 days of treatment (week 4)||||Units on scale, 0-12||Standard Deviation|Mean
1405684|NCT01215279|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline|The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. Baseline is mean of 10 days prior to treatment.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||Units on scale, 0-12||Standard Deviation|Mean
1405685|NCT01215279|Secondary|EXACT Total Score During Last 7 Days of Treatment|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation).|Average of the last 7 days of treatment (week 4)||||Units on scale, 0-100||Standard Deviation|Mean
1405686|NCT01215279|Secondary|Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline|The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). Baseline is the mean value over the 7 days prior to randomisation.|Average of 7 days of pre-treatment measurements (day -7 to -1)||||Units on scale, 0-100||Standard Deviation|Mean
1405687|NCT01215279|Secondary|Evening PEF During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)||||L/minute||Standard Deviation|Mean
1405688|NCT01215279|Secondary|Evening PEF at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L/minute||Standard Deviation|Mean
1405689|NCT01215279|Secondary|Morning PEF During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)||||L/minute||Standard Deviation|Mean
1405690|NCT01215279|Secondary|Morning Peak Expiratory Flow (PEF) at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L/minute||Standard Deviation|Mean
1405691|NCT01215279|Secondary|Evening FEV1 During Last 7 Days of Treatment|Measurement conducted by patient in evening.|Average of the last 7 days of treatment (week 4)||||L||Standard Deviation|Mean
1405692|NCT01215279|Secondary|Evening FEV1 at Baseline|Measurement conducted by patient in evening.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L||Standard Deviation|Mean
1405693|NCT01215279|Secondary|Morning FEV1 During Last 7 Days of Treatment|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of the last 7 days of treatment (week 4)||||L||Standard Deviation|Mean
1405694|NCT01215279|Secondary|Morning FEV1 at Baseline|Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.|Average of 10 days of pre-treatment measurements (day -10 to -1)||||L||Standard Deviation|Mean
1405695|NCT01215279|Primary|Monocytes at Follow-up|Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)|week 5 (follow-up)||||10^9/L||Standard Deviation|Mean
1405696|NCT01215279|Primary|Monocytes at End of Treatment|Monocyte count in peripheral blood at end of treatment (4 weeks)|week 4||||10^9/L||Standard Deviation|Mean
1405697|NCT01215279|Primary|Monocytes at Baseline|Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)|Day 1||||10^9/L||Standard Deviation|Mean
1405698|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Physical Examination|Number of participants with clinically significant changes in physical examination assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
1405699|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in ECG Variables|Number of participants with clinically significant changes in ECG variables assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
1405700|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Number of participants with clinically significant changes in vital signs assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
1405701|NCT01215279|Primary|Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes|Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points|Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)||||Participants|||Number
1405702|NCT01215253|Secondary|Number of Recurrent Inappropriate ICD Shocks|Number of recurrent inappropriate ICD shocks in all patients combined.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||events|||Number
1405703|NCT01215253|Other Pre-specified|Number of Patients Whose First VT/VF Required ICD Shock|number of patients whose first VT or VF required ICD shock|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405704|NCT01215253|Other Pre-specified|Number of Patients Whose First VT/VF Required Antitachycardia Pacing (ATP)|Number of patients whose first VT or VF required antitachycardia pacing (ATP)|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405705|NCT01215253|Secondary|Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. The scale ranges from 0-100 with lower scores indicating worse outcomes.|1 year follow-up|Data was not collected in 42 patients in the placebo arm and 61 patients in the Ranolazine arm.|||units on a scale||Standard Deviation|Mean
1405706|NCT01215253|Secondary|Mean Meters Walked in 6 Minutes|Exercise capacity measured by the 6-minute walk test|1 year of follow-up|Data was not collected on 86 patients in the placebo arm and 99 patients in the Ranolazine arm.|||meters||Standard Deviation|Mean
1405707|NCT01215253|Secondary|Death|Death as a safety endpoint of the trial|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405708|NCT01215253|Secondary|Number of Patients With Heart Failure Hospitalization or Death, Whichever Occurred First|Number of patients with a composite endpoint of heart failure hospitalization or death, whichever occurred first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405709|NCT01215253|Secondary|Number of Patients With Hospitalization for Cardiac Causes or Death, Whichever Occurred First.|Number of patients with a composite endpoint of cardiovascular hospitalization or death, whichever occurred first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405710|NCT01215253|Secondary|Number of Patients With First Inappropriate ICD Shock|Number of patients with first inappropriate ICD shock for other reasons than VT or VF|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405711|NCT01215253|Secondary|Number of Recurrent Episodes of VT or VF Requiring Antitachycardia Pacing (ATP) or ICD Shock Therapies|Total number of recurrent ICD therapies requiring antitachycardia pacing (ATP) or shock will be analyzed, not just first event|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||VT/VF events|VT/VF events||Count of Units
1405712|NCT01215253|Secondary|Number of Patients With VT or VF Requiring ICD Shock or Death|Implantable cardioverter-defibrillator (ICD) shock for VT or VF or death, whichever occurs first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405713|NCT01215253|Primary|Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death|Primary endpoint of the study will be defined as a composite endpoint consisting of Ventricular Tachycardia or Ventricular Fibrillation requiring antitachycardia pacing (ATP) therapy, implantable cardioverter-defibrillator (ICD) shock, or death, whichever occurs first.|2 years of follow-up on average|This outcome measure was an intent-to-treat analysis therefore all randomized subjects were included.|||Participants|||Count of Participants
1405714|NCT01215227|Primary|Percentage Change From Baseline in Total Epworth Sleepiness Scale (ESS) Score at Week 40|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24 with a higher score indicating greater sleepiness.|Baseline and Week 40|Participants in the Full Analysis Set (FAS) population (all randomized participants who received at least one dose of study drug) that had a baseline value and data at Week 40 for Total ESS Score|||Percentage change||95% Confidence Interval|Mean
1405715|NCT01215227|Primary|Percentage of Participants With Suicidality|The number of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1405716|NCT01215227|Primary|Percentage of Participants With Aspartate Aminotransferase (AST) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with AST ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1405717|NCT01215227|Primary|Percentage of Participants With Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal and ≥10% Increase From Baseline|The number of participants with ALT ≥3 times the upper limit of normal and a ≥10% increase was reported. Laboratory safety blood work was collected from participants at Week 4, Week 6, and Week 8 visits.|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1405718|NCT01215227|Primary|Percentage of Participants With Diastolic Blood Pressure ≥105 mmHg|The percentage of participants with Diastolic Blood Pressure ≥105 mmHg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|APaT population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1405719|NCT01215227|Primary|Percentage of Participants With Systolic Blood Pressure ≥180 mmHg|The percentage of participants with Systolic Blood Pressure ≥180 mm Hg was reported. On Day 1 and Early Termination, blood pressure was measured as follows: Participant lay supine for 5 minutes, then had blood pressure taken; then stood for 3 minutes and had blood pressure taken; then rested for 10 minutes, at which time the process was repeated twice (ie, three rounds total). For all other blood pressure measurements, the procedure needed only to be done once (ie, one round).|Up to 42 weeks|All Participants as Treated (APaT) population, which consisted of all participants who received at least one dose of study drug.|||Percentage of participants|||Number
1405720|NCT01215123|Secondary|Treatment Duration: Number of Bevacizumab Cycles|Bevacizumab treatment duration in routine clinical practice was measured by the number of bevacizumab treatment cycles.|Up to a maximum of 36.4 months|All enrolled participants|||cycles||Full Range|Median
1405721|NCT01215123|Primary|Time to Disease Progression (TDP)|Time to disease progression was defined as the time interval between first-line treatment onset and investigator-assessed disease progression. Disease progression was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to a maximum of 36.4 months|All enrolled participants|||months||Full Range|Median
1405722|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Area Under the Concentration-time Curve Over the Dose Interval of 0 to 24 h (AUC(0-24)) on Day 1 and Day 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants|||ng*h/mL||Standard Deviation|Mean
1405723|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Time of Maximum Plasma Concentration (T(Max)) on Days 1 and 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants|||hour||Standard Deviation|Mean
1405724|NCT01215110|Secondary|Summary of Statistical Analysis of TMC207 Maximum Plasma Concentration Following Dosing (C(Max)) on Days 1 and 14||Day 1 (0, 1, 3, 5, 6, 8, 12, and 24 hour post-dose) or Day 14 (0, 1, 3, 5, 6, 8, 12, 24, and 30 hour post-dose)|On Day 14, N=13 for TMC207 300 group and N=14 for TMC207 400 group due to early withdrawal of three participants|||ng/mL||Standard Deviation|Mean
1405725|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 7-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Days 7-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
1405726|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Days 2-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
1405727|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Two consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
1405728|NCT01215110|Secondary|Rate of Change in Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14)|The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) (Bactec MGIT960) automated liquid culture system from overnight sputum. TTP rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group.|Fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, nine participants were omitted from TTP calculations.|||hours/day||Standard Deviation|Mean
1405729|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since this range (Days0-2) is before the node day, the rate of change for this outcome is equal to the slope at Day 0. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Two consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
1405730|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Days 2-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
1405731|NCT01215110|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 7-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Since Day 7 is later than the node day, the rate of change for this outcome is equal to the slope at Day 14. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Days 7-14 of fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
1405732|NCT01215110|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Change of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).|The rates of change were calculated from the two slopes of the bi-linear (piece-wise) regression, for each treatment group. The nodes (point of inflection, i.e. where slope changes) used in these bi-linear regressions, as determined by visual inspection, were Day 3.5. node. Throughout the analyses, the established node at Day 2.5 was used in the Rifafour e-275 arm. Note that to facilitate interpretation the sign of these slopes were reversed for log10CFU/ml.|Fourteen consecutive days of treatment|Because of insufficient data for bilinear regression, four patients were omitted from EBA(CFU) calculations.|||log10CFU/ml/day||Standard Deviation|Mean
1405733|NCT01215097|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
1405734|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
1405735|NCT01215097|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
1405736|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
1405737|NCT01215097|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Participants|||Number
1405738|NCT01215097|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405739|NCT01215097|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405740|NCT01215097|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405741|NCT01215097|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405742|NCT01215097|Secondary|HbA1c Change From Baseline at Week 24(Chinese Only)|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at 24 weeks|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (Chinese only). Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1405743|NCT01215097|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1405744|NCT01215097|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1405745|NCT01215097|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1405746|NCT01215097|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1405747|NCT01215032|Secondary|Percent Maintaining Glycemic Control|To describe glycemic control as assessed by hemoglobin A1C. Glycemic control was defined as maintaining fasting plasma glucose levels less than or equal to 130 mg/dL. Plasma glucose levels were measured at baseline (prior to metformin dosing), pre-month 2, pre-month 4, pre-month 7, pre-month 10 and pre-month 13, and/or at off-study visit.|2 years|Participants were stratified based on baseline hemoglobin A1c. HbA1c < 6.0 is considered normal; HbA1c >/= 6.0 is considered abnormal.|||Participants|||Count of Participants
1405748|NCT01215032|Secondary|Relationship Between Baseline Metabolomic Profile and PSA Response|To determine the plasma metabolomic profiles associated with response to metformin using the Metabolon platform. The Metabolon platform is a proprietary technique of metabolic profiling using mass spectrometry coupled with liquid and/or gas chromatography and robust bioinformatics. The aim is to test the hypothesis that insulin level is a biomarker that predicts activity of metformin therapy for the treatment of castrate-resistant prostate cancer.|2 years|Data was not collected for this outcome measure because blood (plasma) samples were never run on the Metabolon platform, as the study was terminated early.||||||
1405749|NCT01215032|Secondary|Number of Participants With PSA Response|PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.|12 weeks||||Participants|||Count of Participants
1405750|NCT01215032|Primary|PSA (Prostate Specific Antigen) Response|Percent change in PSA from baseline to 12 weeks.|Approximately 12 weeks||||percentage of baseline PSA||Full Range|Median
1405751|NCT01214980|Secondary|Donor Site Recidivism Rate|Number of donor sites that healed and then reopened during the study.|6 weeks|Randomized subjects that had a minimum of 4 out of 5 study treatments and fully epithelialized during the study.|||participants that healed and reopened|||Number
1405752|NCT01214980|Secondary|Numeric Itching Score|Average donor site itching score for treatment group, numeric scale 0 (no itch) to 10 (worst possible itch), at 5 weeks post skin graft procedure|5 weeks|Randomized subjects with a minimum of 4 out of 5 study treatments and itching score reported|||units on a scale||Standard Error|Mean
1405753|NCT01214980|Secondary|Numeric Pain Score|Average donor site pain score for each treatment group, numeric scale of 0 (no pain) to 10 (worst possible pain), at five weeks post skin graft procedure|5 weeks|randomized subjects that had a minimum of 4 out of 5 study treatments and with a numeric pain score reported|||units on a scale||Standard Error|Mean
1405754|NCT01214980|Secondary|Time to Full Epithelialization|Time to full epithelialization in days from the date of initial donor site harvest procedure per the blinded adjudication of the donor site image.|Days to full epithelialization|randomized subjects that had a minimum of 4 out of 5 study treatments|||days||Standard Deviation|Mean
1405755|NCT01214980|Primary|Rate of Wound Healing|The primary endpoint is an average of the group for each participant's donor site wound closure time, defined as days to absence of drainage from the date of the initial donor site harvest procedure.|Days to absence of drainage from the initial donor site harvest procedure|randomized participants that had a minimum of 4 out of 5 treatments|||Days||Standard Deviation|Mean
1405756|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was <600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
1405757|NCT01214915|Secondary|Percentage of Subjects Who Responded in Platelet Count Whose Baseline Platelet Count Was ≥600x10^9/L|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
1405758|NCT01214915|Secondary|Percentage of Subjects With Normalization in Platelet Count|Normalization was defined as platelet counts ≤400x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
1405759|NCT01214915|Secondary|Percentage of Subjects With at Least 50% Reduction in Platelet Count|Subjects who achieved at least 50% reduction in platelet count from their baseline level across consecutive visits for at least 4 weeks and following 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
1405760|NCT01214915|Primary|Percentage of Subjects Who Responded in Platelet Count|A response was defined as platelet counts to <600x10^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.|12 months|Full Analysis Set defined as subjects who had taken at least 1 dose of study medication and had at least 1 post-baseline platelet measurement assessment.|||percentage of subjects||95% Confidence Interval|Number
1405761|NCT01214850|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group|The safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group rMenB+OMV) and one dose of MenACWY-CRM vaccine (Group MenACWY) was assessed in terms of number of subjects with solicited local and systemic adverse events and other adverse events, following vaccination and compared to that of the control group.|Day 1 through day 7 after any vaccination|Analysis was done on the Immunogenicity Subset, Safety Population i.e. all subjects in the exposed population who provided postvaccination safety data.|||number of subjects|||Number
1405762|NCT01214850|Secondary|Percentages of Subjects (Who Have Received a Prior Dose of MenC Vaccine) With hSBA Titers ≥1:8 Against N. Meningitidis Serogroups C and Y After Vaccination With MenACWY-CRM in This Study Compared to Control Group.|"The percentages of subjects (who have received a prior dose of MenC vaccine) with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y after receiving MenACWY-CRM vaccination in this study as compared to the control group are reported.~Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Percentages of subjects||95% Confidence Interval|Number
1405763|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroups C and Y in Subjects (Who Have Received a Prior Dose of MenC Vaccine) After Vaccination With MenACWY-CRM in This Study Compared to Control Group|"The hSBA geometric mean titers against the N. meningitidis serogroups C and Y in subjects (who have received a prior dose of MenC vaccine) after MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.~Analysis was not done for serogroups A and W."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Titers||95% Confidence Interval|Geometric Mean
1405764|NCT01214850|Secondary|Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups C and Y After Vaccination With rMenB+OMV NZ or MenACWY-CRM Compared to Control Group.|"The percentages of subjects with hSBA seroresponse against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination as compared to the control group are reported.~Seroresponse to N. meningitidis serogroups Cand Y is defined as :(1)for subjects with a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer ≥ 1:8 or (2) for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.~Analysis was not done for serogroups A and W."|61 days|Analysis was done on the MITT dataset (Immunogenicity subset)|||Percentages of subjects||95% Confidence Interval|Number
1405765|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The hSBA antibody titers against N. meningitidis serogroups C and Y after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group, are reported as GMTs.~Serogroups A and W were not analysed."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Titers||95% Confidence Interval|Geometric Mean
1405766|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N. Meningitidis Serogroup C and Y, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|"The percentages of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups C and Y, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.~As serogroup A and W strains were not detected in substantial proportion of subjects during pharyngeal carriage analysis, these serogroups were not tested."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Percentages of subjects||95% Confidence Interval|Number
1405844|NCT01214616|Secondary|AUCτ,ss for Afatinib|area under the plasma concentration-time curve following dose at steady state over the dosing interval τ|pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as “with Vinorelbine”) and 20th dose (as “without Vinorelbine”)|Treated set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1405767|NCT01214850|Secondary|The hSBA Geometric Mean Titers Against N. Meningitidis Serogroup B, After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group.|The hSBA Geometric Mean Titers (GMTs) against the three strains of N. meningitidis serogroup B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset)|||Titers||95% Confidence Interval|Geometric Mean
1405768|NCT01214850|Secondary|Percentages of Subjects With hSBA Titers ≥1:4 Against N. Meningitidis Serogroup B After rMenB+OMV NZ or MenACWY-CRM Vaccination Compared to Control Group|The percentages of subjects with hSBA titers ≥1:4 against the three strains of N. meningitidis B, after rMenB+OMV NZ or MenACWY-CRM vaccination at different time points of the study as compared to the control group are reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Immunogenicity subset) i.e all enrolled subjects who actually received a study vaccination, provided at least one evaluable serum sample after vaccination and whose assay result was available for at least one serogroup.|||Percentages of subjects||95% Confidence Interval|Number
1405769|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Serogroup Y After MenACWY-CRM Vaccination, Stratified by Pre-vaccination hSBA Titers|The prevalence of carriage of N. meningitidis serogroup Y, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<8 and ≥8) titers, after administration of one dose of MenACWY-CRM vaccine as compared to the control group is reported.|Up to 12 months after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405770|NCT01214850|Secondary|Percentages of Subjects With N. Meningitidis Carriage of Virulent ST of Group B, Stratified by Pre-vaccination hSBA Titer After rMenB+OMV NZ Vaccination|"The percentages of subjects with N. meningitidis Virulent ST of serogroup B, at different time points of the study, in subjects stratified by pre-vaccination hSBA (<4 and ≥4) titers after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.~The serum bactericidal antibodies directed against N.meningitides serogroups, are measured by Serum Bactericidal Assay using human complement (hSBA).~H44/76, 5/99 and NZ98/254 are strains in serogroup B."|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentage||95% Confidence Interval|Number
1405771|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With MenACWY Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving one dose of MenACWY-CRM vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
1405772|NCT01214850|Secondary|The Duration of Carriage After New Acquisition N.Meningitidis Strains Following Vaccination With rMenB+OMV Vaccine|The duration of carriage after new acquisition of N.meningitidis strains after receiving two doses of rMenB+OMV vaccine compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
1405773|NCT01214850|Secondary|The Duration of Carriage of Any N. Meningitidis Strain After Vaccination With MenACWY-CRM|The duration of carriage of any N meningitidis strain after receiving one dose MenACWY-CRM as compared to that in control group is reported.|Any time post vaccination (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
1405774|NCT01214850|Secondary|The Duration of Any Carriage of N.Meningitidis Strains After Vaccination With rMenB+OMV|The duration of carriage of any N.meningitidis strains after receiving two doses of rMenB+OMV compared to that in the control group is reported.|Any post vaccination timepoint (the date of first observation of the carriage and the date of the last observation of the carriage)|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Number of days||95% Confidence Interval|Least Squares Mean
1405775|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroup Y at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroup Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405776|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Serogroups ACWY at Different Time-points After MenACWY-CRM Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N.meningitidis serogroups A,C, W or Y at different time-points in the study after MenACWY-CRM vaccination as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405777|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of N. Meningitidis Genogroups ABCWY at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of N. meningitidis genogroups ABCWY in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405778|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All N. Meningitidis at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all N. meningitidis in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405845|NCT01214616|Primary|Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course|DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined)|during 1st course|Treated set: all patients who received at least 1 dose of investigational medication (afatinib or vinorelbine)|||participants|||Number
1405779|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of Virulent ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of virulent ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405780|NCT01214850|Secondary|Percentages of Subjects With New Acquisition of Pharyngeal Carriage of All ST Types of N. Meningitidis Genogroup B at Different Time Points Following rMenB+OMV NZ Vaccination|The percentages of subjects with newly acquired pharyngeal carriage of all ST types of N. meningitidis genogroup B in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405781|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405782|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Genogroup Y at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis genogroup Y in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405783|NCT01214850|Secondary|Percentages of Subjects With Carriage of N. Meningitidis Serogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subjects with carriage of N. meningitidis serogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405784|NCT01214850|Secondary|Percentages of Subject With Carriage of N. Meningitidis Genogroups ACWY at Different Time Points After MenACWY-CRM Vaccination|Percentages of subject with carriage of N. meningitidis genogroups ACWY in subjects at different time points of the study after administration of a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405785|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405786|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Genogroup Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis genogroup Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MIIT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405787|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis Serogroups A,C,W or Y at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis serogroups A,C,W or Y in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405788|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ACWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ACWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405789|NCT01214850|Secondary|Percentages of Subjects With Carriage of N.Meningitidis ABCWY Genogroups at Different Time Points After rMenB+OMV NZ Vaccination|Percentages of subjects with carriage of N.meningitidis ABCWY genogroups in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405790|NCT01214850|Secondary|Percentages of Subjects With Carriage of All N.Meningitidis Strain at Different Time Points After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of all N.meningitidis strains combined in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405791|NCT01214850|Secondary|Percentages of Subjects With Carriage of Nonvirulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of nonvirulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405792|NCT01214850|Secondary|Percentages of Subjects With Carriage of Virulent ST Types of N. Meningitidis Group B at Any Time Point After rMenB+OMV NZ Vaccination|Percentage of subjects with carriage of virulent ST types of N. meningitidis group B (genogroupable) in subjects at different time points of the study point after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405793|NCT01214850|Secondary|Percentages of Subjects With Carriage of All ST Types of N. Meningitidis B (Genogroupable) at Different Time Points Following rMenB+OMV NZ Vaccination|The percentage of subjects with carriage of all (virulent + non-virulent) ST types of N. meningitidis B (genogroupable) in subjects at different time points of the study after administration of two doses of rMenB+OMV NZ conjugate vaccine as compared to the control group is reported.|Up to 361 days after vaccination|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405794|NCT01214850|Primary|Percentages of Subjects With Combined Carriage of N. Meningitidis Serogroups A, C, W and Y, One Month After MenACWY-CRM Vaccination|The percentage of subjects with combined carriage rate of N. meningitidis serogroups A, C, W and Y in subjects, one month after receiving a single dose of MenACWY-CRM conjugate vaccine as compared to the control group is reported.|31 days after MenACWY-CRM injection|Analysis was done on the MITT dataset (Pharyngeal carriage)|||Percentages of subjects||95% Confidence Interval|Number
1405795|NCT01214850|Primary|Percentages of Subjects With Carriage of Virulent Sequence Types (ST) of Neisseria Meningitidis Group B, One Month After Completion of rMenB+OMV NZ Vaccination|"Percentages of subjects with carriage of virulent sequence types (ST) of Neisseria meningitidis group B, one month after completion of rMenB+OMV NZ vaccination. The carriage rate of virulent sequence types (ST) of N. meningitidis group B (genogroupable) in subjects, one month after receiving two doses of rMenB+OMV NZ, as compared to the control group, was reported.~Virulent ST types are defined as Clonal Complex multi locus sequence typing (MLST) or ST type being the same compared to history data (Clonal Complexes MLST or ST types found to be virulent and causing diseases) from the years 2006 to 2010."|61 days (31 days after receiving the second injection)|Analysis was done on the modified-intention to treat (MITT) dataset (Pharyngeal carriage), i.e subjects who actually received a study vaccination and provided at least one evaluable swab sample at baseline and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
1405796|NCT01214837|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.||13 months of age|Analysis was done on the Unsolicited Safety Set - All subjects in the Exposed Set with unsolicited adverse event data.|||Subjects|||Number
1405797|NCT01214837|Secondary|Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.|Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.|Day 1 through Day 7|Analysis was done on Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data|||Subjects|||Number
1405798|NCT01214837|Secondary|Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.|Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.|Within 7 days|Analysis was done on the Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data|||Percentage of subjects|||Number
1405799|NCT01214837|Secondary|Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.|Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.|13 months of age.|Analysis was done on the Toddler PPS.|||µg/mL||95% Confidence Interval|Geometric Mean
1405800|NCT01214837|Secondary|Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.|Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.|7 months of age.|Analysis was done on the Infant PPS.|||Percentage of subjects||95% Confidence Interval|Number
1405801|NCT01214837|Secondary|Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.|The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.|||Percentage of subjects||95% Confidence Interval|Number
1405802|NCT01214837|Secondary|GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.|Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.|13 months of age|Analysis was done on the Toddler PPS.|||Titers||95% Confidence Interval|Geometric Mean
1405803|NCT01214837|Secondary|Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.|The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age|Analysis was done on the Toddler PPS.|||Titers||95% Confidence Interval|Geometric Mean
1405804|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.|Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.|12 months of age.|Analysis was done on the Toddler PPS.|||Percentage of subjects||95% Confidence Interval|Number
1405805|NCT01214837|Secondary|Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.|Analysis was done on the Infant PPS.|||Titers||95% Confidence Interval|Geometric Mean
1405806|NCT01214837|Secondary|Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.|Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.|Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age|Analysis was done on Infant PPS - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding, through the 7 month timepoint.|||Percentages of subjects||95% Confidence Interval|Number
1405807|NCT01214837|Primary|Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.|13 months of age|Analysis was done on Toddler PPS.|||Percentage of subjects||95% Confidence Interval|Number
1405808|NCT01214837|Primary|Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.|The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.|13 months of age|Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.|||Percentage of subjects||95% Confidence Interval|Number
1405809|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked|Proportion of time (hours per day) in hypoglycaemia (<3.9mmol/L) for the unmasked phase|2 weeks following baseline & 3 months|Analysis per protocol 31 participants analysed in the unmasked phase 1 28 participants analysed in the unmasked phase 2|||Hours per day||Standard Deviation|Mean
1405810|NCT01214824|Secondary|Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked|Proportion of time (hours per day) in hypoglycaemia (<3.9 mmol/L) for the masked phase. There were two masked phases in the study, one 5 day wear at baseline and one 5 day wear at 6 months. During masked wear subject were not able to see continuous glucose data from the device.|Baseline & 6 months|Analysis per protocol|||Hours per day||Standard Deviation|Mean
1405811|NCT01214824|Secondary|Number of Subjects Who Had Reduction in HbA1c of > or = 0.5%|Number of subjects with a HbA1c reduction greater than or equal to 0.5% and 95% confidence interval from visit 1 (baseline) to visit 7 (6 months).|Baseline and 6 months|Intention to treat analysis|||participants|||Number
1405812|NCT01214824|Primary|Change in HbA1C From Baseline to 6 Months|HbA1c at baseline HbA1c at 6 months Change in HbA1c(%)(6 months – baseline)|Baseline and 6 months|Intention to treat analysis|||HbA1c %||Standard Deviation|Mean
1405813|NCT01214811|Primary|Wound Area at Visit 2|At each visit the wound length and width is measured and calculated in cm2.|After one week||||cm2||Standard Deviation|Mean
1405814|NCT01214811|Primary|Wound Are at Baseline||Baseline|||||||
1405815|NCT01214759|Secondary|Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study||28 days|All who were enrolled|||participants|||Number
1405816|NCT01214759|Secondary|Number of Participants Exhibiting Clinical or Laboratory Abnormalities Resulting From the 28-day Exposure to the Antiretroviral Drugs Being Explored in This Study|Participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table for grading the severity of adult and pediatric adverse events were tested for clinical or laboratory abnormalities.|28 days|Only participants who experienced side effects categorized as grade 3 or higher by the Division of AIDS table were tested for clinical or laboratory abnormalities, and since no participants experienced side effects greater than grade 1, no participants were tested for clinical or laboratory abnormalities.||||||
1405817|NCT01214759|Primary|Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months|This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV.|6 months|All who completed all study visits|||participants|||Number
1405818|NCT01214720|Secondary|Bevacizumab Concentration in the Presence of Gemcitabine and Erlotinib|Blood samples were collected from a subgroup of participants, in selected centers for the determination of bevacizumab serum concentration before the first bevacizumab/placebo exposure (Week 1) and at Weeks 3, 5, 7, and 9. Each time blood samples were collected just (preferably within 1 hour) before the start of the study treatment.|Weeks 1, 3, 5, 7, and 9|ITT Population. Number (n) = number of participants assessed at a specific visit.|||micrograms/milliliter||Standard Deviation|Geometric Mean
1405819|NCT01214720|Primary|Duration of Overall Survival - Time to Event|Duration of OS was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median duration of survival was estimated using the Kaplan-Meier method.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT Population.|||months||95% Confidence Interval|Median
1405820|NCT01214720|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at First Postbaseline Tumor Assessment|Percentage of participants with CR, PR, or SD according to modified RECIST evaluation at the first postbaseline tumor assessment. CR equaled (=) complete disappearance of all target lesions and non-target disease, with normalization of tumor marker level. PR is greater than or equal to (≥) a 30% decrease of the sum of the LD of all target lesions as referenced to the baseline sum LD of all target lesions. Persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits. SD=neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD with persistence of one or more non-target lesions(s) and/or maintenance of tumor marker level above normal limits.|Baseline and Week 8|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1405821|NCT01214720|Secondary|Progression-Free Survival (PFS) - Time to Event|PFS was defined as the time between the date of randomization and the date of documented PD (per RECIST), or date of death due to any cause. Data for participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization. Median PFS was estimated using the Kaplan-Meier method.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT Population|||months||95% Confidence Interval|Median
1405822|NCT01214720|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time between the date of randomization and the date of documented progressive disease (PD) defined according to modified Response Evaluation Criteria in Solid Tumors (RECIST) evaluation, or date of death due to any cause. PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum (LD) recorded since the treatment started. Participants without an event were censored at the date of last follow up for progression, or date of last available tumor assessment if no further follow up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Screening, Weeks 8, 16, 24, 32, 40, and every 12 weeks thereafter or until confirmed evidence of disease progression|ITT population.|||percentage of participants|||Number
1405823|NCT01214720|Secondary|Clinical Benefit Response (CBR)||Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|The analysis of the CBR was dependent on the calculation of analgesic therapy (AT); this calculation relies on established conversion factors for different morphine derivatives (MD). Many MD utilized by participants do not have well-established conversion factors, yielding uninterpretable results. Therefore, CBR was not analyzed in this study.||||||
1405824|NCT01214720|Primary|Duration of Overall Survival - Percentage of Participants With an Event|Duration of overall survival (OS) was defined as the time between date of randomization and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants who were randomized but not exposed to study drug and had no further follow up were censored at the date of randomization.|Randomization, Weeks 1-8 of Cycle 1, Weeks 1-3 of consecutive cycles, 28 days and 3 months after lst treatment, and every 3 months for up to 18 months from last participant randomized|ITT population.|||percentage of participants|||Number
1405825|NCT01214642|Secondary|Number of Participants With Tumor Response|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and the Revised International Working Group (IWG) lymphoma response criteria for lymphoma patients. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Tumor response is CR + PR.|Baseline to measured disease progression or discontinuation up to Cycle 38 (21-day cycles)|All participants who received 1 dose of LY2523355.|||participants||90% Confidence Interval|Number
1405826|NCT01214642|Secondary|Pharmacokinetic Areas Under the Concentration Time Curve (AUC), Multiple Dose|Plasma AUC from time zero to infinity (0-∞) and AUC from time zero to 24 hours (0-24) post-dose following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 2 doses of study drug and had pharmacokinetic samples collected on Day 4, 5, 8, or 9 of Cycle 1 (based on schedule of administration) to enable calculation of AUC(0-∞) and AUC(0-24) after multiple dose administration of LY2523355.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1405827|NCT01214642|Secondary|Pharmacokinetics Area Under the Concentration-time Curve (AUC), Single Dose|Plasma AUC from time zero to infinity [AUC(0-∞)] and AUC from time zero to 24 hours post-dose [AUC(0-24)] following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 1 dose of LY2523355 and had pharmacokinetic samples collected on Day 1 of Cycle 1 to enable calculation of AUC(0-∞) and AUC(0-24).|||nanograms*hour/milliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1405828|NCT01214642|Secondary|Pharmacokinetics Maximum Concentration (Cmax), Multiple Dose|Plasma Cmax following multiple doses of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Days 4, 5, 8 or 9 of 21-day cycle:Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 2 doses of study drug and had a Cmax sample collected on Days 4, 5, 8 or 9 of Cycle 1 (based on schedule of administration) after multiple dose administration of LY2523355.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1405829|NCT01214642|Secondary|Pharmacokinetics Maximum Concentration (Cmax), Single Dose|Plasma Cmax following a single dose of LY2523355 at each dose level across all schedules and in the presence or absence of pegfilgrastim (PEG).|Cycle 1 Day 1 of 21-day cycle: Predose, 1 hour (hr), 2,4,6,8,24,48 and 72 hr postdose|All participants who received 1 dose of LY2523355 and had Cmax samples collected on Day 1 of Cycle 1.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1405830|NCT01214642|Secondary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and other non-serious AEs is located in the Reported Adverse Events module.|Baseline to Cycle 38 (21-day cycles): daily for AEs|All participants who had at least 1 dose of LY2523355.|||Participants|||Count of Participants
1405863|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0%|Number of patients with HbA1c < 7.0% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
1405831|NCT01214642|Primary|Recommended Dose and Schedule for Phase 2 Studies|The recommended dose and schedule for Phase 2 studies is defined as the maximum tolerated dose (MTD). MTD is defined as the dose level at which no more than 2 dose limiting toxicities (DLTs), no more than 3 dose reductions (DR) or dose omissions (DO) and no more than 1 DLT plus 2 DR/DO occurred. DLT is defined as an adverse event (AE) occurring in Cycle 1 with the following criteria according to the National Cancer Institute’s (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0: Any ≥Grade 3 nonhematological toxicity (except nausea/vomiting or diarrhea controlled with treatment or fatigue); ≥Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with bleeding; Grade 4 hematological toxicity of >5 days duration, excluding thrombocytopenia; febrile neutropenia.|Cycle 1 (21 days): Day 1, 5 and 9, any AE reported|All participants who received at least 1 dose of LY2523355.|||mg/m^2/day|||Number
1405832|NCT01214629|Secondary|Number of Participants With Tumor Response|Data presented are the number of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions.|Baseline to measured disease progression or discontinuation up to 617 days|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1405833|NCT01214629|Secondary|Pharmacokinetics: AUC(0-∞) of LY2523355 Following Multiple Doses|AUC(0-∞) following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1, Day 3(21-day cycle): End of infusion|All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 3 of Cycle 1.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1405834|NCT01214629|Secondary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2523355 Following A Single Dose|AUC(0-∞) following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1,Day 1(21-day cycle): End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime|All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable calculation of the LY2523355 AUC(0-∞) on Day 1 of Cycle 1.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1405835|NCT01214629|Secondary|Pharmacokinetics: Plasma Cmax of LY2523355 Following Multiple Doses|Cmax following multiple doses of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1, Day 3(21-day cycle): End of infusion|All enrolled participants who received more than 1 dose of LY2523355 and had evaluable pharmacokinetic data to enable determination of the LY2523355 Cmax on Day 3 of Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405836|NCT01214629|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2523355 Following A Single Dose|Cmax following a single dose of LY2523355 at each dose level in the presence or absence of pegfilgrastim.|Cycle 1 Day 1(21-day cycle):End of infusion (EOI), Day 2: Predose, EOI, Day 3: Predose, EOI, between 1-2 hour EOI, Day 4: anytime, Day 8:anytime, Day 9: anytime, Day 10: anytime|All enrolled participants who received 1 dose of LY2523355 on Day 1 of Cycle 1 with evaluable pharmacokinetic data to enable determination of the LY2523355 plasma Cmax on Day 1 of Cycle 1.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1405837|NCT01214629|Secondary|Number of Participants With Clinically Significant Effects|Adverse events (AEs) were considered clinically significant effects. Data presented are the number of participants who experienced serious AEs (SAEs), other non-serious AEs and deaths during the study, including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion including 30-day follow-up up to 647 days,any AE reported|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1405838|NCT01214629|Primary|Recommended Dose for Phase 2 Studies|Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). The MTD was defined as the dose that caused <1/3 of all participants treated with the study drug to experience a dose-limiting toxicity (DLT). A DLT was defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 3.0 Grade ≥3 nonhematological toxicity possibly or likely related to the study drug (except for nausea/vomiting/diarrhea without maximal symptomatic/prophylactic treatment); any CTCAE v 3.0 Grade ≥3 thrombocytopenia with bleeding; any CTCAE v3.0 Grade 4 hematological toxicity of >5 days duration; any febrile neutropenia.|Baseline, daily up to 21 days in Cycle 1|All enrolled participants who received at least 1 dose of study drug.|||mg/m²/day|||Number
1405839|NCT01214616|Primary|Drug-related Adverse Events|Number of patients with drug-related adverse events|during the treatment period or up to 28 days after the completion of drug administration, up to 730 days|Treated set|||participants|||Number
1405840|NCT01214616|Secondary|Objective Tumour Response|"According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Pre-treatment, every 8 weeks after start of study treatment, end of treatment|Treated set|||participants|||Number
1405841|NCT01214616|Secondary|Cmax for Vinorelbine|maximum measured blood concentration|predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as “with afatinib”) and 1st dose (as “without afatinib”)|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405842|NCT01214616|Secondary|AUC0-∞ for Vinorelbine|area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity|predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as “with afatinib”) and 1st dose (as “without afatinib”)|Treated set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1405843|NCT01214616|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration at steady state|pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as “with Vinorelbine”) and 20th dose (as “without Vinorelbine”)|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405880|NCT01214161|Secondary|Adverse Events||During IUD insertion||||participants|||Number
1405846|NCT01214434|Secondary|Percent Reduction From Baseline for Oiliness at End of Treatment.|Oiliness scored on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
1405847|NCT01214434|Secondary|Percent Reduction From Baseline for Erythema at End of Treatment.|Erythema scored on scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
1405848|NCT01214434|Secondary|Percent Reduction From Baseline for Crusting at End of Treatment.|Crusting scored on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
1405849|NCT01214434|Secondary|Precent Reduction From Baseline for Scaling at End of Treatment.|Scaling score on a scale of 0 (none) to 4 (severe).|From Baseline to end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percent reduction from baseline||Standard Deviation|Mean
1405850|NCT01214434|Primary|Number of Participants With Excellent Overall Safety Score at End of Treatment.|The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).|End of treatment|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||participants|||Number
1405851|NCT01214434|Primary|Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).|IGA scored on scale of 0 (clear) to 4 (severe).|end of treatment (Day 7 or 14)|All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.|||percentage of participants|||Number
1405852|NCT01214395|Secondary|The Number of Patients That Did Not Have a Staphylococcus Aureus Infection||6 months|counted|||participants|||Number
1405853|NCT01214395|Primary|Primary Endpoint Will be the Number of Tea Tree Oil Patients That Did Not Have a Catheter-related Infection Within 6 Months After Entry Into the Trial.|"Catheter-related infections will be defined according to standard guidelines~Cases with definite and probable infections will be classified as infections."|6 months||||participants|||Number
1405854|NCT01214330|Secondary|Patient Attitudes|Results from SoloPap Patient Questionairre regarding patient attitudes.|6 months|||||||
1405855|NCT01214330|Primary|Concordance (Similarity Between Samples) of Pap Smears|Is the SoloPap collection device as good at detecting cervical dysplasia as a clinician-collected Pap Smear?|1 year|102 females recruited from an outpatient clinic in a military treatment facility, age >18, without severe hand arthritis|||percentage of participants|||Number
1405856|NCT01214252|Secondary|Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed|Confirmed and Unconfirmed hernia or hernia recurrence by year from Year 2 to last year observed|Year 2 to Year 8||||participants|||Number
1405857|NCT01214252|Secondary|Total Unconfirmed Hernia or Hernia Recurrence|"Total unconfirmed hernia or hernia recurrence at the repair site by year (Number and percentage)~Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms Questionniare but not confirmed by clinical assessment by a surgeon or medical chart review"|12 Months||||participants|||Number
1405858|NCT01214252|Primary|Confirmed Hernia Recurrence|Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review|12 months||||participants|||Number
1405859|NCT01214239|Secondary|Number With HbA1c at Least Lowering 0.5%|Number with HbA1c at least 0.5% lowering from baseline at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
1405860|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%.|Number of patients with HbA1c < 6.5% at week 24 with baseline HbA1c >= 6.5%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
1405861|NCT01214239|Secondary|Number of Patients With HbA1c < 6.5%|Number of patients with HbA1c < 6.5% at week 24|baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
1405862|NCT01214239|Secondary|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%.|Number of patients with HbA1c < 7.0% at week 24 with baseline HbA1c >= 7.0%.|baseline and at week 24|This population includes the FAS with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||Patients|||Number
1405864|NCT01214239|Secondary|FPG Change From Baseline at Week 24|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405865|NCT01214239|Secondary|FPG Change From Baseline at Week 18|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405866|NCT01214239|Secondary|FPG Change From Baseline at Week 12|Means are treatment adjusted for baseline FPG and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405867|NCT01214239|Secondary|FPG Change From Baseline at Week 6|Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1405868|NCT01214239|Secondary|HbA1c Change From Baseline at Week 24 in the Subset of Chinese Patients|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available (in the subset of Chinese patients). Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
1405869|NCT01214239|Secondary|HbA1c Change From Baseline at Week 18|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
1405870|NCT01214239|Secondary|HbA1c Change From Baseline at Week 12|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
1405871|NCT01214239|Secondary|HbA1c Change From Baseline at Week 6|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
1405872|NCT01214239|Primary|HbA1c Change From Baseline at Week 24|Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and at week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||% of HbA1c||Standard Error|Least Squares Mean
1405873|NCT01214187|Secondary|St George's Respiratory Questionnaire|St. George's Respiratory Questionnaire (SGRQ) is a validated self-reported instrument. In this instrument, scores range from 0 to 100, with higher scores reflective of worse quality of life.|Baseline to Week 12||||Total Score||Standard Error|Least Squares Mean
1405874|NCT01214187|Secondary|Six Minute Walk Distance|The six minute walk distance is commonly used both in research studies and in clinical practice as a measure of functional capabilities, and changes in six minute walk distance and oxygen use during testing over time often reflect clinically relevant disease progression. We will measure the distance travelled during six minutes (meters) in accordance with published guidelines|Baseline to Week 12||||meters||Standard Error|Least Squares Mean
1405875|NCT01214187|Secondary|Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values|Interstitial changes associated with IPF can worsen diffusing capabilities across the alveolar-capillary membrane. As a result, diffusing capacity of carbon monoxide is an important outcome to assess architectural distortion and resultant decrements in diffusing capabilities|Baseline to Week 12||||% predicted||Standard Error|Least Squares Mean
1405876|NCT01214187|Secondary|Total Lung Capacity % Predicted Values (TLC)|Total lung capacity % predicted values (TLC) is a major clinical determinant of restrictive lung disease in practice, with TLC measurement below the 5th percentile of the predicted value indicative of a restrictive ventilatory defect|Baseline to Week 12||||% Predicted||Standard Error|Least Squares Mean
1405877|NCT01214187|Primary|Serum MMP7 Level|The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. Serum MMP7 concentrations in peripheral blood are easily measureable and reflect changes in the alveolar microenvironment. Thus, we have chosen to study mean serum MMP7 concentrations after three months of CO treatment as a surrogate biomarker of the effect of inhaled CO administration on disease progression.|Baseline to Week 12|One subject randomized to placebo withdrew consent prior to the MMP7 blood draw at visit 2. This is missing data and the reason why we have n=28 for placebo group.|||ng/ml||Standard Error|Least Squares Mean
1405878|NCT01214174|Primary|Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.|8 days post-treatment||||percentage of patients with ACC clearing||95% Confidence Interval|Number
1405879|NCT01214161|Secondary|Provider's Assessment of Patient's Maximum Pain on a Visual Analogue Scale|This secondary analysis looked at provider perception of patient maximum pain during IUD insertion This was not done per intervention because we were looking at the accuracy of the provider's assesment of the patient's pain, which is not dependent on intervention. The provider was blinded to the intervention so that would not have influenced results.|during IUD insertion||||units on a 100 mm visual analogue scale||Standard Deviation|Mean
1405881|NCT01214161|Primary|Pain During IUD Insertion at Various Time Points (See Description for Time Points)|Patient marked pain on a 100 mm visual analogue scale during the part of the IUD insertion procedure where the tenaculum was placed, the uterus was measured/sounded, the IUD was inserted into the uterus, and the speculum was removed.|During IUD insertion (see above description for which time points)||||units on a 100 mm visual analogue scale||Standard Deviation|Mean
1405882|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (Excluding Subjects Due to Emesis)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Vz/F,ss excluding subjects with reported emesis|||L||Geometric Coefficient of Variation|Geometric Mean
1405883|NCT01214109|Secondary|Apparent Volume of Distribution During the Terminal Phase at Steady State Following Oral Administration (Vz/F,ss) for PK Population (All Subjects)|Vz/F,ss = Apparent volume of distribution during the terminal phase λz at steady state following oral administration|27 days|PK Population - Subjects with values for Vz/F,ss|||L||Geometric Coefficient of Variation|Geometric Mean
1405884|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (Excluding Subjects Due to Emesis)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population excluding subjects with reported emesis - Subjects with values for CL/F,ss excluding subjects with reported emesis|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1405885|NCT01214109|Secondary|The Apparent Clearance of the Analyte in Plasma at Steady State Following Oral Administration (CL/F,ss) for PK Population (All Subjects)|CL/F,ss = Apparent clearance of the analyte in the plasma at steady state following oral administration|27 days|PK Population - Subjects with values for CL/F,ss|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1405886|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cmin,ss excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405887|NCT01214109|Secondary|Minimum Steady State Concentration (Cmin,ss) for PK Population (All Subjects)|Cmin,ss = Minimum observed concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cmin,ss|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405888|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (Excluding Subjects Due to Emesis)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for t1/2,ss excluding subjects with reported emesis|||h||Geometric Coefficient of Variation|Geometric Mean
1405889|NCT01214109|Secondary|Terminal Half-life of the Analyte in Plasma at Steady State (t1/2,ss) for PK Population (All Subjects)|t1/2,ss - Apparent plasma terminal elimination half-life at steady state|27 days|PK Population - Subjects with values for t1/2,ss|||h||Geometric Coefficient of Variation|Geometric Mean
1405890|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (Excluding Subjects Due to Emesis)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population excluding subjects with reported emesis - Subjects with values for Cavg excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405891|NCT01214109|Secondary|Average Concentration in Plasma Under Steady-state Conditions (Cavg) for PK Population (All Subjects)|Cavg = Average concentration of the analyte in plasma at steady state|27 days|PK Population - Subjects with values for Cavg|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405892|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (Excluding Subjects Due to Emesis)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cpre,ss excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405893|NCT01214109|Secondary|Predose Steady State Concentration of the Analyte Immediately Before Administration of the Next Drug Administration (Cpre,ss) for PK Population (All Subjects)|Cpre,ss = pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose|27 days|PK population - Subjects with values for Cpre,ss|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405894|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (Excluding Subjects Due to Emesis)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population excluding subjects with reported emesis - Subjects with values for PTF excluding subjects with reported emesis|||percent||Geometric Coefficient of Variation|Geometric Mean
1405895|NCT01214109|Secondary|Peak-to-trough Fluctuation (PTF) for PK Population (All Subjects)|PTF = Peak-to-trough fluctuation is measured as a percent|27 days|PK population - Subjects with values for PTF|||percent||Geometric Coefficient of Variation|Geometric Mean
1405896|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (Excluding Subjects Due to Emesis)|tmax = time of maximum observed plasma concentration|27 days|PK population excluding subjects with reported emesis - Subjects with values for t_max excluding subjects with reported emesis|||hours||Full Range|Median
1405897|NCT01214109|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte in Plasma (Tmax) for PK Population (All Subjects)|tmax = time of maximum observed plasma concentration|27 days|PK population - Subjects with values for tmax|||hours||Full Range|Median
1405898|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (Excluding Subjects Due to Emesis)|Cmax,ss = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for Cmax,ss excluding subjects with reported emesis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405899|NCT01214109|Primary|Maximum Steady State Concentration (Cmax,ss) for PK Population (All Subjects)|Cmax = maximum observed concentration of the analyte in plasma at steady state|27 days|PK population - Subjects with values for Cmax,ss|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1405900|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for PK Population (Excluding Subjects Due to Emesis)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population excluding subjects with reported emesis - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER, excluding subjects with reported emesis|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1405901|NCT01214109|Primary|Area Under the Concentration-time Curve of Pramipexole in Plasma at Steady State Over 24 Hours (AUC0-24,ss); in Case of ER up to the Time Point of Next Dosing (AUCtau,ss) for Pharmacokinetic (PK) Population (All Subjects)|AUC0-24,ss = area under the plasma concentration-time curve between 0 and 24 hours at steady state. AUCtau,ss = area under the plasma concentration-time curve over a dosing interval at steady state|27 days|PK population - Subjects with values for AUC0-24,ss for IR and values for AUCtau,ss for ER|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1405902|NCT01214083|Secondary|Liver Function Tests (ALT)||week 0 and week 13||||units/liter||Standard Error|Mean
1405903|NCT01214083|Secondary|Drinks Per Drinking Days||week 1 and week 13||||drinks/drinking day||Standard Error|Mean
1405904|NCT01214083|Secondary|Percentage of Drinking Days|"Percentage of drinking days was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days)."|week 1 and week 13||||percentage of drinking days||Standard Error|Mean
1405905|NCT01214083|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life).|week 1 and week 13||||units on a scale||Standard Error|Mean
1405906|NCT01214083|Secondary|Clinical Global Impression (CGI)|The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness).|week 1 and week 13||||units on a scale||Standard Error|Mean
1405907|NCT01214083|Secondary|Obsessive Compulsive Drinking Scale (OCDS)|The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems).|week 1 and week 13||||units on a scale||Standard Error|Mean
1405908|NCT01214083|Secondary|Penn Alcohol Craving Scale (PACS)|The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving).|week 1 and week 13||||units on a scale||Standard Error|Mean
1405909|NCT01214083|Secondary|Liver Function Tests (AST)||week 0 and week 13||||units/liter||Standard Error|Mean
1405910|NCT01214083|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking)."|week 1 and week 13||||percentage of heavy drinking days||Standard Error|Mean
1405911|NCT01213966|Primary|Derived Parasite Reduction Rate at 24 Hours (PPR24)|"PRR24 is the log10 change in parasitemia over 24 hours estimated from a regression model fit separately for each patient. The relationship between parasite counts and time was analyzed by fitting a variable lag phase, then a linear decline to the natural log of parasite count versus time relationship. The slope of this log linear relationship is the primary end-point.~The time points chosen for the regression are those that yield the highest degree of significance when assessing the regression when the number of time points are greater than or equal to 3. No extrapolation was performed."|24 hours after study drug administration||||Log10 parasites/24h||Full Range|Median
1405912|NCT01213836|Secondary|Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2.|The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively.|End of Period 1, end of Period 2|21 patients for the FAS were analysed. This outcome measure was introduced as a protocol amendment after study start and plasma concentration was not measured in all patients. FAS is all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.|||Ratio||Standard Deviation|Mean
1405913|NCT01213836|Secondary|Number of Dropouts.|The number of patients who dropped out was counted.|Period 1 and Period 2|The Safety analysis set was used, that is all patients who received at least one dose of study medication and for whom any post-dose safety data are available were included in the safety set.|||participants|||Number
1405914|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label|"Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie).~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.|||units on a scale||Standard Deviation|Mean
1405956|NCT01213251|Primary|Change in Left Ventricular End Diastolic Volume (LVEDV)|"Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV.~Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|The primary analysis cohort for the main objective of this study (Change in Left Ventricular End Diastolic Volume) required a subject to be randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.|||mL||95% Confidence Interval|Mean
1405915|NCT01213836|Secondary|Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label|"The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres.~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group."|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The full analysis set (FAS) used for analysis of efficacy included all patients who, in both study periods, received at least one dose of investigational product and for whom post-dose efficacy data are available in both periods.|||units on a scale||Standard Deviation|Mean
1405916|NCT01213836|Secondary|Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving|International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|Per Protocol (PPS), subset of the FAS consisting of patients who fulfilled all of inclusion but none of exclusion criteria, complied with study medication dosing, did not violate any of the restrictions and completed the study without protocol violation.|||Units on a scale||Standard Deviation|Mean
1405917|NCT01213836|Secondary|Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)|"TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction.~There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group."|Before taking study drug, end of Period 1 and end of Period 2|Full Analysis Set (FAS)used for efficacy analysis included all patients who in both study periods, received at least 1 dose of investigational product and for whom post-dose efficacy data was available.|||units on a scale||Standard Deviation|Mean
1405918|NCT01213836|Primary|Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)|Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment.|Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.|The per protocol set (PPS) is a subset of the FAS consisting of patients who fulfilled all inclusion criteria but none of the exclusion criteria, complied with study medication dosing scheme, did not violate any of the study restrictions and completed the study without protocol violation.|||standardised units||Standard Deviation|Mean
1405919|NCT01213823|Primary|Number of Any Severe Hepatic Injury Cases and Matched Controls|Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [ULN] and direct bilirubin >2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels >3 times ULN and less than (<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.|01 June 2006 to 30 June 2008 (up to 25 Months)|Acute-care participants, with at least 1 dose of echinocandin antifungal therapy and a primary or secondary International Classification of Diseases 9 (ICD-9).|||Participants|||Number
1405920|NCT01213706|Primary|Airway Blood Flow Response to Albuterol|Airway Blood Flow will be measured before and 15 minutes after the 180 mcg of albuterol inhalation.|Qaw post minus Qaw pre albuterol after WBPA or Sham WBPA|controls n =15, smokers N=15 , asthma N=15|||μl/min/ml||Standard Error|Mean
1405921|NCT01213589|Secondary|Clinical Success|"Clinical success was defined as: (i) successful introduction and deployment of the Valiant Thoracic Stent Graft at the intended location; (ii) successful coverage of the proximal entry tear; (iii) no immediate conversion to open surgery;(iv) absence of surgical open repair or endovascular re-intervention; (v) absence of death related to aortic disease or treatment; (vi) absence of graft thrombosis, obstructions, twists or kinks; (vii) absence of graft migration;(viii) absence of graft integrity failure; (ix) at the level of the ostium of the LSA, the more proximal entry tear of the dissection, the largest section of the thoracic aorta, and at the first image/slice available with upper part of the liver:~Absence of true lumen decrease in diameter (≥ 5 mm is significant) Absence of increase in total aortic diameter (≥ 5 mm is significant)"|through 36 months||||participants|||Number
1405922|NCT01213589|Secondary|Freedom From Disease-, Procedure-, or Device-related Severe Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death.~Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related severe complications"|through 36 months||||Percentage Event Free|||Number
1405957|NCT01213199|Primary|Global Scarring Severity|"Grade Level:~Macular disease~Mild disease~Moderate disease~Severe disease"|Week 24|The analysis population includes 18 subjects whose data were available at this time frame (week 24).|||units on a scale||Standard Deviation|Mean
1405923|NCT01213589|Secondary|Freedom From Disease-, Procedure- or Device-related Major Complications|"Complications were assigned a severity score (according SVS scores) so that degrees of morbidity can be assessed and compared. A moderate complication indicates the need for significant intervention, prolongation of hospitalization more than 24 hours, and at most, minor permanent disability that does not preclude normal daily activity. A severe complication necessitates major surgical or medical intervention, may be associated with prolonged convalescence, is usually accompanied by prolonged or permanent disability, and may result in death. Both moderate and severe complications are considered as major complications.~Kaplan-Meier estimate of freedom from disease-, procedure-, or device-related major complications by clinical group."|through 36 months||||Percentage Event Free|||Number
1405924|NCT01213589|Secondary|Freedom of Re-intervention|Kaplan-Meier estimate of freedom from secondary procedures by clinical group.|30 days or at discharge, 3/6/12/24/36 months||||Percentage Event Free|||Number
1405925|NCT01213589|Secondary|Efficacy/Performance|- Technical Success Technical success, defined as a composite of (i) successful introduction and deployment of at least one Valiant Thoracic Stent Graft at the intended location, (ii) successful coverage of the proximal entry tear, (iii) no immediate conversion to open surgery during the same intervention, (iv) absence of death within 24 hours post-procedure, and (v) the absence of significant graft twist, kink or obstruction by intra-operative measurements|30 days or at discharge, 3/6/12/24/36 months||||participants|||Number
1405926|NCT01213589|Secondary|Safety|"All causes mortality~Disease-, procedure- or device-related mortality"|30 days or at discharge, 3/6/12/24/36 months||||participants|||Number
1405927|NCT01213589|Primary|Disease-, Procedure- or Device-related Mortality at 12 Months Post-procedure|Disease, device or procedure-related mortality at 12 months post-procedure, defined as any death related to the device, to the disease or to the surgical procedure occurring in the period of 365 days following the day of the implant procedure.|12 months post-procedure||||participants|||Number
1405928|NCT01213576|Secondary|Number of Participants With Microfilarial Clearance at 24 Months of Follow up|Microfilaria will be detected using the nucleopore filtration technique and analysed according to the respective treatment arms at the 24 month time point. Microfilarial clearance will be defined by non-detection of microfilaria in the night blood sample|24 months|Intention to treat, with last result carried forward in the case of missing visit|||participants|||Number
1405929|NCT01213576|Primary|Number of Participants Achieving Microfilarial Clearance|Microfilaria clearance will be assessed in regard to dosage as well as frequency of treatment. Microfilarial clearance is defined by non-detection of microfilaria in the night blood sample.|12 months|Number of participants with non detectable microfilaria at follow up|||participants|||Number
1405930|NCT01213329|Secondary|Identify Development of Donor-specific Hyperactivity|Identify, by studying recipients for development of donor specific hyperactivity and through immunopathologic analysis of renal allograft biopsies, immunologically stable renal transplant patients in whom immunosuppression can be safely minimized.|Pre-transplant, 6mo & 12mo post-transplant|||||||
1405931|NCT01213329|Primary|The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.|Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months & 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells & NK cells, naive & memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). To also obtain quantification of donor specific antibody cells for class I & class II donor HLA antigens, and measurement of C-reactive protein cells(marker of inflammation). 50cc of urine also obtained for measurement of urinary cytokines & markers of inflammation.|Pre-transplant, 6months & 12 months post-transplant|samples from 26 recipient/donor pairs were collected = 52 analyzed. Some samples were discarded due to processing inconsistencies.||||||
1405932|NCT01213316|Secondary|Percentage of Aging Participants Taking Concomitant Medications at Baseline|The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Percentage of participants|||Number
1405933|NCT01213316|Secondary|Percentage of Aging Participants With Concomitant Diseases at Baseline|The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Percentage of participants|||Number
1405934|NCT01213316|Secondary|Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.|||Percentage risk||Standard Deviation|Mean
1405958|NCT01213173|Secondary|The Change From Baseline in Triglycerides|Difference of change from baseline in TG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.|||mmol/L||95% Confidence Interval|Least Squares Mean
1405959|NCT01213173|Secondary|The Change From Baseline in Fasting Plasma Glucose|Difference of change from baseline in FPG after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.|||mmol/L||95% Confidence Interval|Least Squares Mean
1405935|NCT01213316|Secondary|Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period and had evaluable results.|||Percentage risk||Standard Deviation|Mean
1405936|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||CD4+ T-cells/µL||Standard Deviation|Mean
1405937|NCT01213316|Secondary|HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Log10 Copies/mL||Standard Deviation|Mean
1405938|NCT01213316|Secondary|Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment|Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.|||CD4+ T-cells/µL||Standard Deviation|Mean
1405939|NCT01213316|Secondary|HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment|The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.|||Log10 Copies/mL||Standard Deviation|Mean
1405940|NCT01213316|Secondary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined.|Baseline and 96 weeks|The analysis set included participants in the Initial Cohort who received at least one dose of raltegravir during the observation period.|||Percentage of participants||95% Confidence Interval|Number
1405941|NCT01213316|Primary|Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included aging participants (Prolonged Participants and Newly Enrolled Participants) who received at least one dose of raltegravir during the observation period.|||Percentage of participants||95% Confidence Interval|Number
1405942|NCT01213316|Primary|Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment|The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.|Baseline and 48 weeks|The analysis set included all participants who received at least one dose of raltegravir during the observation period.|||Percentage of participants||95% Confidence Interval|Number
1405943|NCT01213264|Primary|Type of NMB-reversal Agent Administered to Study Participants|For all participants who received an NMB-reversal agent, the specific agent administered was recorded.|At administration of NMB-reversal agent (up to approximately 395 minutes after start of surgery)|All study participants who received an NMBA or NMB-reversal agent|||participants|||Number
1405944|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Recovery Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Recovery Room. The time of dismissal from the Recovery Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical and recovery period (up to approximately 170 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.|||minutes||Standard Deviation|Mean
1405945|NCT01213264|Secondary|Time From NMB-reversal Agent Administration to Operating Room Dismissal|This measure is the duration from NMB-reversal agent administration to dismissal of the participant from the Operating Room. The time of dismissal from the Operating Room was to be recorded for each participant, irrespective of the criteria used to make the decision to dismiss the participant.|Post-surgical period (up to approximately 24 hours post-surgery)|Evaluable participants who received an NMB-reversal agent and had available procedure duration data. Participants in the Spontaneous Reversal group did not receive any NMB-reversal agents and therefore were not included in this analysis.|||minutes||Standard Deviation|Mean
1405946|NCT01213264|Primary|Type of Surgical Procedure Performed in Study Participants|The type of surgical procedure performed in each study participant was recorded.|Day of surgery (Day 1)|All study participants who received a neuromuscular blocking agent (NMBA) or NMB-reversal agent|||participants|||Number
1405960|NCT01213173|Secondary|The Change From Baseline in Total Cholesterol|Difference of change from baseline in TC after 8 weeks treatment between groups.|After 8 weeks treatment|All subjects who received at least one dose of randomized investigational product was included in the safety population.|||mmol/L||95% Confidence Interval|Least Squares Mean
1405947|NCT01213264|Primary|Time From End of Surgery (End of Last Stitch) to Extubation|"This measure is the duration from the last surgical wound stitch to the post-surgical extubation of the participant. The time of extubation was to be recorded for each participant, irrespective of the criteria used to make the decision to extubate the participant. Data are presented by TOF-ratio <0.9 and ≥0.9 at extubation. The TOF-ratio is a measure of neuromuscular function ranging from 0.0 to 1.0. The greater the T4/T1 ratio the greater~the recovery from neuromuscular blockade. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications."|From end of surgery (end of last stitch) to extubation (duration of approximately <1 to 62 minutes)|Evaluable participants with TOF-ratio measurement at time of extubation and available procedure duration data. Three sugammadex participants with duration from end of surgery to extubation >1 hour were excluded from analysis; delay of extubation was considered due to factors unrelated to administration of sugammadex.|||minutes||Standard Deviation|Mean
1405948|NCT01213264|Primary|Number of Participants With a Train-Of-Four (TOF)-Ratio <0.9 at Extubation|Neuromuscular function assessment was performed according to routine anesthesiology practice. This typically involves application of repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve and assessment of twitch response at the adductor pollicis muscle. The TOF-ratio, expressed as a decimal from 0.0 up to 1.0, is the ratio of the magnitude of the fourth twitch (T4) to that of the first twitch (T1). The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade. The TOF-ratio was measured at the time of post-surgical extubation. TOF-ratio at time of extubation was to be recorded for each participant, if available, irrespective of the criteria used to make the decision to extubate the participant. TOF-ratio <0.9 at extubation is considered to indicate a high risk for development of postoperative residual curarization (i.e, residual neuromuscular blockade), which can result in respiratory complications.|At extubation (approximately <1 to 125 minutes after end of surgery)|Evaluable participants with TOF-ratio measurement at time of extubation|||participants|||Number
1405949|NCT01213251|Secondary|Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.|"Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable.~Variables resulting in statistical significant (p<0.05) are reported."|Baseline - 18 Month Follow Up Visit|All subjects randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed LVEDV at baseline and 18-month follow-up visit are included.|||regression coefficient||Standard Error|Mean
1405950|NCT01213251|Secondary|Incidence of Sudden Cardiac Death and Total Mortality|"Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods.~Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control."|18 Months post-randomization|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.|||percentage of subjects at risk||95% Confidence Interval|Number
1405951|NCT01213251|Secondary|Change in Quality of Life|"Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit.~Change is defined as month 18 minus baseline.~Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control."|Baseline - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed MNLWHF questionnaire score at baseline and 18-month follow-up visits are included.|||units on a scale||95% Confidence Interval|Mean
1405952|NCT01213251|Secondary|Change in 6-minute Walk Test Distance|"Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit.~Change is defined as month 18 minus baseline.~Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control."|1 Month - 18 Month Follow Up Visit|Randomized subjects, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed 6-minute hallwalk distance at baseline and 18-month follow-up visits are included.|||meters||95% Confidence Interval|Mean
1405953|NCT01213251|Secondary|Change in New York Heart Association (NYHA) Functional Class|"The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort.~NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as “Improved”. Similarly for “Worsened” (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects’ NYHA Class is not different than baseline, then the subject was classified as No Change.~Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control."|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant. Moreover, only subjects with observed NYHA at baseline and 18-month follow-up visit are included.|||participants|||Number
1405954|NCT01213251|Secondary|Frequency of Hospitalization for Cardiovascular Events|Number of hospitalizations related to cardiovascular events.|Baseline - 18 Month Follow Up Visit|Subject was randomized, and if randomized to Dual Site or Single Site, the subject must have had a successful implant.|||participants|||Number
1405955|NCT01213251|Secondary|Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events|Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.|18 months post-implant|Only subjects with attempt implant are included. Therefore, subjects from the Control Arm are not included.|||survival probability||95% Confidence Interval|Number
1405961|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Attacks per week||95% Confidence Interval|Least Squares Mean
1405962|NCT01213173|Secondary|The Difference of Change From Baseline in Angina Frequency Between Groups|Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Attacks per week||95% Confidence Interval|Least Squares Mean
1405963|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 8 weeks treatment.~Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||mm*min||95% Confidence Interval|Least Squares Mean
1405964|NCT01213173|Secondary|The Difference of Change From Baseline in Total Ischemic Burden Between Groups|"Difference in change from baseline in TIB between two groups after 2 weeks treatment.~Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc)."|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||mm*min||95% Confidence Interval|Least Squares Mean
1405965|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups|After 8 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Participants|||Number
1405966|NCT01213173|Secondary|The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups|Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups|After 2 weeks treatment|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Participants|||Number
1405967|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||95% Confidence Interval|Least Squares Mean
1405968|NCT01213173|Secondary|The Different Impact on 24-hr Average Heart Rate Between Two Groups|Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.|After 2 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||Standard Deviation|Mean
1405969|NCT01213173|Secondary|The Impact on 24-hr Average Heart Rate From Baseline Within Groups|Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||95% Confidence Interval|Least Squares Mean
1405970|NCT01213173|Primary|The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)|Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.|After 8 weeks treatment in the study|ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.|||Bpm||Standard Deviation|Mean
1405971|NCT01213082|Secondary|Number of Anti-VEGF Injections Administered|efficacy measure|Month 24||||number of anti-VEGF injections per eye||Standard Deviation|Mean
1405972|NCT01213082|Primary|Percent of Eyes With Severe Ocular Adverse|vision loss of 3 or more lines associated with radiation retinopathy or papillopathy|Month 24||||percentage of participants|||Number
1405973|NCT01213043|Primary|Number of Treatment-Emergent Pulmonary Exacerbations|Total number of treatment-emergent pulmonary exacerbations.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||Events|||Number
1405974|NCT01213043|Primary|Number of Drug-related TEAEs|Total number of drug-related TEAEs reported|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||Events|||Number
1405975|NCT01213043|Primary|Number of TEAEs|Total number of TEAEs reported.|22 Weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||Events|||Number
1406618|NCT01206465|Secondary|Number of Patients Experiencing Grade 3-4 Toxicity While Receiving the Combination of PDX and 5-FU|patients remained on study as long as they did not progress, and wished to continue on study (no limit on number of cycles)|"., From the time the subject signs the consent form and ending 4 weeks following the final chemotherapy, an average of 3 years"||||participants|||Number
1405976|NCT01213043|Secondary|Mean Trough|The average trough concentration at steady-state, calculated as the mean value using the four Trough measurements obtained at Weeks 6, 7, 8 and at 7 days (168 hours) post infusion at Week 8 for the first treatment period or prior to the start of the infusions at Weeks 16, 17, 18, and at 7 days (168 hours) post infusion at Week 18 for the second treatment period.|Single measurment immediately prior to infusion at Weeks 6, 7, 8, 9 and Weeks 16, 17, 18, 19|PK Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.|||μM||Standard Deviation|Mean
1405977|NCT01213043|Primary|Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s)|Number of subjects who experienced at least one severe TEAE or pulmonary exacerbation.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
1405978|NCT01213043|Primary|Subjects With Treatment-Emergent Pulmonary Exacerbation(s)|Number of subjects with at least one treatment-emergent pulmonary exacerbation|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
1405979|NCT01213043|Primary|Subjects Withdrawn Due to an AE(s)|Number of subjects who were withdrawn from the study due to at least one AE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
1405980|NCT01213043|Primary|Subjects With Treatment-Emergent Serious Adverse Events (SAEs)|Number of subjects who experienced at least one treatment-emergent SAE.|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
1405981|NCT01213043|Primary|Subjects With Drug-Related TEAE(s)|Number of subjects with at least one TEAE that was determined by the Investigator to be either “possibly related” or “related” to the investigational product (i.e., Prolastin-C).|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
1405982|NCT01213043|Secondary|AUC0-7days|Area Under the Alpha-1 PI Concentration-Time Curve from Day 0 to Day 7|Week 8 and Week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose|Pharmacokinetic (PK) Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters.|||h*mg/mL||Standard Deviation|Mean
1405983|NCT01213043|Primary|Subjects With Treatment-Emergent Adverse Events (TEAEs)|Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C).|22 weeks|All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C).|||participants|||Number
1405984|NCT01212991|Secondary|Best Overall Soft Tissue Response|The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.|During study period (up to 3 years)|Intent to treat (ITT) population With Measurable Disease - All participants who were randomly assigned to treatment and had at least one target lesion at screening.|||Percentage of participants|||Number
1405985|NCT01212991|Secondary|Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%|PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.|During study period (up to 3 years)|Evaluable intent to treat (ITT) population - All patients randomly assigned to treatment with PSA values at baseline and at least one postbaseline assessment.|||Percentage of Participants||95% Confidence Interval|Number
1405986|NCT01212991|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomized.|||months||95% Confidence Interval|Median
1405987|NCT01212991|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.|||months||95% Confidence Interval|Median
1405988|NCT01212991|Secondary|Time to First Skeletal-related Event|Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.|||months||95% Confidence Interval|Median
1405989|NCT01212991|Primary|Radiographic Progression-free Survival|Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.|During study period (up to 20 months)|Intent to Treat (ITT) - All patients randomly assigned to treatment excluding 84 patients who were not randomized before the radiographic Progression-free Survival data cutoff date of 06 May 2012.|||months||95% Confidence Interval|Median
1405990|NCT01212991|Primary|Overall Survival|Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.|During study period (up to 3 years)|Intent to Treat (ITT) - All patients randomly assigned to treatment.|||months||95% Confidence Interval|Median
1405991|NCT01212874|Secondary|Title: Systolic Hypertension|Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.|||mmHg*min / prebypass hour||95% Confidence Interval|Median
1405992|NCT01212874|Primary|Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour|Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass|Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours|Data capture failure lost data from 2 treated patients in each group; these were thus excluded from analysis.|||mmHg*min/prebypass hour||95% Confidence Interval|Median
1405993|NCT01212770|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.|Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg BID|Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.|||participants|||Number
1405994|NCT01212770|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.|Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)|Safety population = participants who received at least one dose of IP;1 participant randomized to 30 mg APR who received PBO in error is counted in the PBO group;1 participant randomized to PBO who received 30 mg APR in error is counted in the 30 mg group;1 participant randomized to PBO who received 20 mg APR in error is counted in the 20 mg group|||participants|||Number
1406116|NCT01212185|Secondary|CIWA-Ar Scores|Clinical Institute Withdrawal Assessment for Alcohol (CIWA) scale modified to include vital sign measurements. The CIWA scale measures each of 10 alcohol withdrawal symptoms between 0 and 6 (least to worst). Also in the modified CIWA score are ratings of body temperature (0-3, normal range to increasingly elevated), pulse (0-6), respirations (0-2), and diastolic blood pressure (0-6). So the range of possible total scores on the modified CIWA is 0-77.|days 1||||units on a scale||Standard Deviation|Mean
1405995|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1405996|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1405997|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1405998|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1405999|NCT01212770|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants|||Number
1406000|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406001|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406002|NCT01212770|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406003|NCT01212770|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: •28 tender joint count •28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; •C-reactive protein (CRP) •Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406004|NCT01212770|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: •28 tender joint count (TJC), •28 swollen joint count (SJC), •Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; •Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406005|NCT01212770|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406006|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406007|NCT01212770|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||mm||Standard Deviation|Mean
1406008|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52|The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with Baseline Psoriasis Body Surface Area ≥ 3% and a Week 52 value are included.|||percentage of participants||95% Confidence Interval|Number
1406009|NCT01212770|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406117|NCT01212185|Primary|Total Lorazepam Dosage (in Milligrams)|Total lorazepam (in milligrams) required per subject to complete detoxification|Days 1 to 5||||milligrams of lorazepam||Standard Deviation|Mean
1406010|NCT01212770|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406011|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406012|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406013|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406014|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406015|NCT01212770|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406016|NCT01212770|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406118|NCT01212172|Secondary|Pain Rating Scale|Pain during each treatment was measured subjectively by patients on a 0–10 visual analogue scale (0=no pain, 10=unbearable pain).|12 months||||Units on a Scale||95% Confidence Interval|Median
1406017|NCT01212770|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406018|NCT01212770|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406019|NCT01212770|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406020|NCT01212770|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406021|NCT01212770|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406022|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406023|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406024|NCT01212770|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406025|NCT01212770|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406026|NCT01212770|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406027|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406028|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406029|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406030|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406119|NCT01212172|Primary|Change in Hair Growth|% reduction from baseline hair count at time points 1 month, 6 months and 12 months [following last (5th laser) treatment]|1 month, 6 month, 12 month||||% hair reduction||Standard Deviation|Mean
1406120|NCT01212159|Secondary|LDL Values at Two Week Interval|Participant in the self monitored arm reported LDL every two weeks. LDL goal for treatment was 100 mg/dl and subjects were followed every two weeks to observe mean LDL values.|6 weeks|No self monitoring group had LDL levels only at baseline and 6 months.|||mg/dl||Standard Deviation|Mean
1406031|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406032|NCT01212770|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
1406033|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24|The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 24|Full analysis set; participants with baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406034|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406035|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406036|NCT01212770|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406037|NCT01212770|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406121|NCT01212159|Secondary|Medication Compliance|Self reported comparison of lipid medication compliance between control and intervention subjects, scale 0-4. Highest compliance value indicated by a score of 4.|6 months||||units on a scale||Standard Deviation|Mean
1406122|NCT01212159|Primary|LDL Level Change From Baseline|Comparison of serum LDL level between control and intervention subjects|baseline to 6 months||||mg/dl||Standard Deviation|Mean
1406038|NCT01212770|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406039|NCT01212770|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406040|NCT01212770|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406041|NCT01212770|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
1406042|NCT01212770|Secondary|Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16|The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 16|Full analysis set; participants with a baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406043|NCT01212770|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406044|NCT01212770|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406059|NCT01212757|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406045|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406046|NCT01212770|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406047|NCT01212770|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1406048|NCT01212770|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406049|NCT01212757|Secondary|Number of Participants With TEAEs During the Apremilast-Exposure Period|"A treatment emergent adverse event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). The severity of each adverse event (AE) and serious AE (SAE) was assessed by the investigator and graded based on a scale from Mild - mild symptoms to Severe AEs (non-serious or serious). A serious adverse event (SAE) is any AE which:~Resulted in death~Was life-threatening~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Constituted an important medical event"|Week 0 to week 260; overall median duration of exposure to apremilast 20 mg and 30 mg BID was 198 weeks|Apremilast subjects as treated who received at least 1 dose of apremilast at any time during the study at week 0, week 16 or week 24.|||participants|||Number
1406050|NCT01212757|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Placebo-Controlled Phase|"A treatment emergent adverse event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). The severity of each adverse event (AE) and serious AE (SAE) was assessed by the investigator and graded based on a scale from Mild - mild symptoms to Severe AEs (non-serious or serious). A serious adverse event (SAE) is any AE which:~Resulted in death~Was life-threatening~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Constituted an important medical event"|Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)|Safety population included all participants who were randomized and received at least one dose of IP.|||Participants|||Number
1406051|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406052|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406053|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406054|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406055|NCT01212757|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants|||Number
1406056|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406057|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406058|NCT01212757|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406154|NCT01211665|Primary|Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent||Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
1406060|NCT01212757|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406061|NCT01212757|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406062|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406063|NCT01212757|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||mm||Standard Deviation|Mean
1406064|NCT01212757|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406065|NCT01212757|Secondary|Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406066|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1406074|NCT01212757|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406067|NCT01212757|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1406068|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406069|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406070|NCT01212757|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406071|NCT01212757|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406072|NCT01212757|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406073|NCT01212757|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406075|NCT01212757|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406076|NCT01212757|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406077|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406078|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406079|NCT01212757|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406080|NCT01212757|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406081|NCT01212757|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406347|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 24|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 24|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
1406082|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406083|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406084|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406085|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406086|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406087|NCT01212757|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
1406088|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406107|NCT01212445|Secondary|Mean Participant Global Assessment of Treatment|At the End of Study Visit, the study staff asked the participant to rate their global assessment of the study treatment according to the following categories: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective.|From time of study drug administration up to 2 Days|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.|||units on a scale||Standard Deviation|Mean
1406619|NCT01206465|Secondary|Number of Participants With Response to Therapy in Subjects With Measurable Disease||restaging imaging done after each two 4-week course until time of progression (the maximum duration of PFS = 588 days)||||Participants|||Count of Participants
1406089|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406090|NCT01212757|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means “not at all,” and 4 means “very much.” The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406091|NCT01212757|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: - 28 tender joint count - 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; - C-reactive protein (CRP) - Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406092|NCT01212757|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: - 28 tender joint count (TJC), - 28 swollen joint count (SJC), - Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; - Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406093|NCT01212757|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406094|NCT01212757|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406095|NCT01212757|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents “no pain,” and the right-hand boundary (score = 100 mm) represents “pain as severe as can be imagined.” The distance from the mark to the left-hand boundary was recorded in millimeters.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
1406096|NCT01212757|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: - 78 tender joint count, - 76 swollen joint count, - Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; - Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406097|NCT01212757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1406098|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1406099|NCT01212757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1406100|NCT01212757|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1406101|NCT01212757|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an ACR20 response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦Patient’s self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦C-Reactive Protein.|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol; participants who were randomized in error and did not receive any dose of study drug were excluded. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1406102|NCT01212627|Secondary|Check the Tolerability, and Maximum Tolerated Dose (MTD) of Several Dosing Schedules of Oral Ridaforolimus.|the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin|1 year|||||||
1406103|NCT01212627|Primary|Determine Maximum Tolerated Dose (MTD) of Ridaforolimus With Given With Cetuximab|"the first testing will occur once the first 3 patients are enrolled and have received 1 cycle DLT's will be evaluated- if everything is ok then the next level of medication will begin~Weekly Ridaforolimus Dose Level 1 20 mg/day Dose Level 2 30 mg/day Dose Level 3 40 mg/day"|1 year||||mg/day|||Number
1406104|NCT01212484|Primary|24 Hour Dopamine Levels|Assay of 24 hour dopamine level excretion in urine|4 weeks||||ug/gCR||Standard Deviation|Mean
1406105|NCT01212484|Secondary|Number of Episodes of Daily Nausea||4 weeks||||episodes of nausea||Standard Deviation|Mean
1406106|NCT01212484|Primary|Composite Daily Score|Daily scores were reported on a modified version of the Rhodes Index of Nausea, Vomiting and Retching, which included all 5 items relating to nausea and retching. Items addressing vomiting/throwing up were omitted, as all participants had antireflux surgery that prevented vomiting (Nissen fundoplication). Retching distress, nausea distress, number of nausea episodes per day, number of retching episodes per day, and the amount of time spent feeling nauseous were graded on a 5-point scale. Scores range from 0 (no nausea/distress) to 20 (most nausea/distress).|4 weeks||||units on a scale||Standard Deviation|Mean
1406108|NCT01212445|Secondary|Mean VAS Rating for Abdominal Discomfort/Cramping|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Abdominal Discomfort/Cramping VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related abdominal discomfort/cramping. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Abdominal discomfort/cramping ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Painful.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
1406109|NCT01212445|Secondary|Mean VAS Rating for Bloating|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Bloating VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related bloating. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Bloating ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
1406110|NCT01212445|Secondary|Mean VAS Rating for Gas|"The VAS is a psychometric response scale which measures responses along a continuum of values. The Gas VAS uses a 100 mm horizontal line with the two ends representing opposite, extreme limits of the participant's experience with BM-related gas. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. Gas ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=None and 100 mm= Severe.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group."|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
1406111|NCT01212445|Secondary|Mean Visual Analog Scale (VAS) Rating for BM Control|"The VAS is a psychometric response scale which measures responses along a continuum of values. The BM control VAS uses a 100 mm horizontal line with the two ends representing the opposite, extreme limits of the participant's experience of BM control. Participants marked where they felt they resided between the two ends with a vertical line. The distance from the left end of the VAS (0 mm) to the participant's mark was measured and recorded in mm. BM Control ratings ranged on a continuous scale from 0 to 100 mm, where 0 mm=Calm, not urgent and 100 mm= Not able to hold BM, very urgent.~Participants completed a VAS after every BM or attempted BM. The VAS ratings recorded in the diaries for each BM were averaged (with range) to yield a single score for each participant. Participant scores were then averaged by treatment group"|From time of study drug treatment up to 24 hours|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had data available.|||mm||Standard Deviation|Mean
1406112|NCT01212445|Secondary|Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 12 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.|||percentage of participants|||Number
1406113|NCT01212445|Secondary|Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration|Time to first successful bowel movement was defined as the duration (in days) from the time of first study dose of study treatment until first successful BM (defined as BM without straining and without hard and/or lumpy stool).|From time of study drug administration up to 3 Days|Participants in the ITT Population (defined as all participants who were randomized regardless of whether they had taken study treatment) who had a successful bowel movement (no straining or hard/lumpy stools). Participants who reported no successful BMs were censored.|||participants|||Number
1406114|NCT01212445|Primary|Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration|A successful BM was defined as a BM with no straining or hard/lumpy stools.|From time of study drug treatment up to 24 hours|Intent-to-Treat (ITT) Population: defined as all participants randomized regardless of whether they had taken study treatment.|||percentage of participants|||Number
1406115|NCT01212302|Primary|Number of Participants Who Were Responders or Low-Responders of Antiplatelet Therapy as a Result of Whole Blood Aggregometry Testing (See Outcome Measure Description)|"In patients treated with aspirin and clopidogrel aggregometry was performed and depending on the results the patients were either responder or low-responder of antiplatelet therapy.~The following definitions were used for clopidogrel low response (CLR: >5 ohm when stimulated with adenosine diphosphate (ADP) 5 μM) and ASA low response (ALR: >0 ohm;stimulated with arachidonic acid 10 μM) with the ChronoLog 590 aggregometer. In the case of low-response alternative antiplatelet therapy was modified according to the study plan (see protocol section)."|2 years|Sample size calculation: With the assumption that the incidence of clopidogrel low response was at least 20% and ASA low response 10%. Choosing a power of 97.5% and a two-sided value of 0.05, an overall sample size was required of at least 400 patients. To compensate for a possible loss of follow-up, we aimed for inclusion of approx. 500 patients.|||participants||95% Confidence Interval|Number
1406155|NCT01211665|Primary|Time Course Change in Clinical Laboratory Values|Clinical laboratory values included chemokines, cytokines, C-reactive protein (CRP), John Cunningham (JC) virus load, and cell count in cerebrospinal fluid.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
1406123|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||Z score||Inter-Quartile Range|Median
1406124|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
1406125|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
1406126|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.~trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|0 Months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||units on a scale||Inter-Quartile Range|Median
1406127|NCT01212094|Secondary|EDSS|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|0 months||||units on a scale||Inter-Quartile Range|Mean
1406128|NCT01212094|Secondary|Multiple Sclerosis Functional Composite (MSFC)|The MSFC is a three-part standardized assessment tool that measures arm, leg, and cognitive function. The scoring is based on the average Z-score for all three parts of the the assessment.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||Z score||Inter-Quartile Range|Median
1406129|NCT01212094|Secondary|9-Hole Peg Test|"Measure of upper extremity (arm and hand) function where patients are asked to pick up one peg at a time, using one hand only, and putting them into the holes as quickly as possible until all the holes are filled and then removing them one at a time as quickly as possible. The dominant and non-dominant hands are tested twice. The time limit per trial is 5 minutes.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
1406130|NCT01212094|Secondary|Timed 25 Foot Walk|"Measure of mobility and leg function based on a timed 25 foot walk. Patient is directed to walk as quickly as possible, with or without an assitive device, to one end of a 25foot course and this is repeated for a total of 2 times. The score is the average of the two completed trials.~Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||seconds||Inter-Quartile Range|Median
1406131|NCT01212094|Secondary|Scripps Neurological Rating Scale (NRS)|"NRS is a quantitative assessment based on 22 parameters of the neurological exam with scores ranging from maximum of 100 (normal neurological exam) to a minimum of -10 (death due to MS). The higher the score, the better the patient's level of function.~trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes makes no sense"|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility.|||units on a scale||Inter-Quartile Range|Median
1406132|NCT01212094|Secondary|Expanded Disability Status Scale (EDSS)|Trial was closed prematurely and therefore formal statistical analysis of the acquired clinical outcomes was not performed. EDSS is a clinical rating scale for disability ranging from 0 (normal neurological exam) to 10 (death due to MS) in half point increments.|24 months|Only 5 patients per group finished Month 24 following 2 years in study drug phase of trial (2 IV doses and 3 IT doses) at the time the study was terminated for futility|||units on a scale||Inter-Quartile Range|Median
1406133|NCT01212094|Primary|Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of B-cell activating factor (BAFF) before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. BAFF is consumed by B cells, therefore effective B cell depletion increases levels of BAFF. The protocol-stipulated threshold for trial continuation was at least 50% increase in CSF BAFF induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug.|||percentage of BAFF change||Inter-Quartile Range|Median
1406156|NCT01211665|Primary|Time Course Change in Magnetoencephalography (MEG) Results|MEG was used to map brain activity.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; no data on this endpoint was collected.||||||
1406134|NCT01212094|Primary|Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of chemokine CXCL13 before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. CXCL13 is released by activated B cells, T cells and by follicular dendritic cells and has been linked previously with MS inflammation in the brain and spinal cord. The protocol-stipulated threshold for trial continuation was at least 25% decrease in CSF CXCL13 induced by active treatment with significance level p=0.025.|3 months|For the decision to continue trial, only change from baseline to 3 months post-treatment was analyzed in patients who received active drug|||percentage of b cell depletion||Inter-Quartile Range|Median
1406135|NCT01212094|Secondary|Analysis of Changes in CSF B Cell Numbers Between Rituximab and Placebo|This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares absolute numbers of CSF B cells calculated as proportion of B cells (identified from flow cytometry data) in all immune cells measured in 50-fold concentrated CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing.|3 months|These patients were analyzed for the interim analysis for the efficacy of B cell depletion. Trial stipulated stopping criteria for futility.|||percentage of b cell depletion||Inter-Quartile Range|Median
1406136|NCT01211873|Secondary|Measure Blood Sample.||up to 24 hours|||||||
1406137|NCT01211873|Secondary|Injection-site Tolerance on the Visual Analog Scale From 0 (no Pain) to 10 (Maximal Pain).||up to 24 hours|||||||
1406138|NCT01211873|Secondary|Measure ECG||up to 24 hours|||||||
1406139|NCT01211873|Secondary|Measure Vital Signs (Supine Systolic and Diastolic Blood Pressures, Pulse).||up to 24 hours|||||||
1406140|NCT01211873|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability.||up to 29 days|||||||
1406141|NCT01211873|Secondary|Number of Lesions With MRI Signal Intensity Changes After Contrast Agent Injection.||up to 24 hours as the safety is assessed till 24 hours after injection|||||||
1406142|NCT01211873|Secondary|Level of Diagnostic Confidence on 5-point Scale Ranging From Nil to Excellent With Poor, Moderate and High as Intermediate Grades.||up to 24 hours as the safety is assessed till 24 hours after injection|||||||
1406143|NCT01211873|Secondary|The Quality of Images on 3-point Scale: Poor, Fair or Good.||up to 24 hours as the safety is assessed till 24 hours after injection|||||||
1406144|NCT01211873|Primary|"MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both Pre and Paired Evaluation, Each Lesion is Scored With 3-point Scales."|"To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.~Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. Pre refers to unenhanced MRI. PAIRED refer to combined unenhanced and enhanced MRI.~The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0."|up to 24 hours as the safety is assessed till 24 hours after injection|The primary analysis was performed at the patient level using off-site readings by 3 readers. The number of participants for analysis depended on the number of evaluable cases (pre and paired)determinted by each reader. Only adult participants included in this data set.|||units on a scale||Standard Deviation|Mean
1406145|NCT01211769|Secondary|Obsessive Compulsive Drinking Scale (OCDS)|The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 – 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.|3 months||||Units on a Scale||Standard Deviation|Mean
1406146|NCT01211769|Secondary|Short Alcohol Dependence Data Questionnaire (SADD)|The Short Alcohol Dependence Data is a self-completion questionnaire designed to evaluate the presence and the degree of severity of alcohol dependence and consists of 15 questions. The minimum and maximum scores possible are 0 and 45 points respectively. The range of 1-9 is considered as low dependence, 10-19 medium dependence and 20 or more high dependence.|3 months||||Units on a Scale||Standard Deviation|Mean
1406147|NCT01211769|Primary|"Drinking Days in the Previous Month"|The Alcohol Timeline Followback (TLFB) is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time period that can vary up to 12 months from the interview date.|3 months||||Days||Standard Deviation|Mean
1406148|NCT01211730|Secondary|Death Within 1 Year|Death following liver transplant between 1 day and 1 year|1 year||||participants|||Number
1406149|NCT01211730|Secondary|Overall Graft Survival at 1 Year||1 year following transplantation||||participants|||Number
1406150|NCT01211730|Secondary|Rehospitalization Rates||Within 1 year following transplantation|patients undergoing liver transplant|||participants|||Number
1406151|NCT01211730|Secondary|Infection Rates||Within 1 year following transplantation|patients having had liver transplants|||participants|||Number
1406152|NCT01211730|Secondary|Hypoglycemia|Participants experiencing hypoglycemia (glucose < 70 mg/dL) within the first 3- days following transplantation|Within first 3 days following transplantation|Patients having liver transplant|||participants|||Number
1406153|NCT01211730|Primary|Rejection of Liver Transplant|Liver transplant rejection determined by either biopsy or clinical criteria (>2x transaminases, clinical decision, treatment with high dose steroids and other anti-rejection medications|within 1 year of transplantation|Patients undergoing liver transplant|||participants|||Number
1406157|NCT01211665|Primary|Time Course Changes in Brain Magnetic Resonance Imaging (MRI)|The brain MRI data collected included: progressive multifocal leukoencephalopathy (PML) lesion localization, T2 hyperintense lesion volume, and signs of cerebral edema.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
1406158|NCT01211665|Primary|Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT)|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
1406159|NCT01211665|Primary|Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale|The GCI-I scale is a 7-point scale that assesses how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rates it as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Screening to 6 months following completion of PLEX (participants began treatment with intravenous methylprednisolone (IVMP) within 2 weeks after PLEX [or equivalent]).|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
1406160|NCT01211665|Primary|Severity of AEs and SAEs|AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant’s daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period||||events|||Number
1406161|NCT01211665|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period||||participants|||Number
1406162|NCT01211665|Primary|Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)|Following the completion of rapid removal of natalizumab using PLEX or equivalent.|6 months||||participants|||Number
1406163|NCT01211665|Primary|Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)|The Karnofsky Performance Status Index (KPSI) is an assessment tool intended to assist clinicians and caretakers in gauging a patient's functional status and ability to carry out activities of daily living. A KPSI of 100=normal, no complaints, no evidence of disease; 90=able to carry on normal activity, minor signs or symptoms of disease; 80=normal activity with effort, some signs or symptoms of disease; 70=cares for self, unable to carry on normal activity or do active work; 60=requires occasional assistance but is able to care for most personal needs; 50=requires considerable assistance and frequent medical care; 40=disabled, requires special care and assistance; 30=severely disabled, hospitalization is indicated, although death is not imminent; 20=very sick, hospitalization is necessary, active support treatment is necessary; 10=moribund, fatal processes progressing rapidly; 0=dead.|Baseline up to 6 months|This study was stopped prematurely due to lack of enrollment; this analysis was not performed.||||||
1406164|NCT01211613|Secondary|Numeric Pain Rating Score.|Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating “no pain” and 10 indicating “unbearable pain”. Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment).|4 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
1406165|NCT01211613|Primary|Oswestry Low Back Pain Disability Index|The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).|4 weeks (post treatment)||||units on a scale||Standard Deviation|Mean
1406166|NCT01211535|Primary|Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, how your eyes feel right now. A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort."|Baseline (Day 0), Day 14|All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)|||Units on a scale||95% Confidence Interval|Least Squares Mean
1406167|NCT01211340|Secondary|Anxiety|This measure determines the level of anxiety experienced by a hospice caregiver. Total scores range from 0-21 with higher scores representing more anxiety. Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure||||units on a scale||Standard Deviation|Mean
1406168|NCT01211340|Secondary|Caregiver Quality of Life-Revised Subscale Emotional|This is one domain of a four domain instrument. It involves one question with a range of 0-10.Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure||||units on a scale||Standard Deviation|Mean
1406169|NCT01211340|Primary|Caregiver Perceptions of Pain Medicine Questionaire|This 16 question instrument measures the perceptions hospice caregivers have toward the administration of pain medications. Scores on items vary from 1-5 with the lower scores indicating more problematic perceptions of pain management. A Total score is computed between 16-80 Only the last available measure will be used to reflect the measure closest to time of death.|Every 14 days until the death of the patient for an average of 45 days-Only measure used in analysis is the last completed measure||||units on a scale||Standard Deviation|Mean
1406170|NCT01211197|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events.|Drug administration up to 7 days after last drug administration, up to 8 days|Treated set (TS) includes all subjects who took at least 1 dose of investigational medication and was used for safety analysis.|||participants|||Number
1406171|NCT01211197|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||Litres||Standard Deviation|Mean
1406172|NCT01211197|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of the analyte in the plasma after extravascular administration.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||mL/min||Standard Deviation|Mean
1406173|NCT01211197|Secondary|Mean Residence Time in the Body After Oral Administration (MRTpo)|"Mean residence time of the analyte in the body after oral administration.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||hours||Standard Deviation|Mean
1406174|NCT01211197|Secondary|Terminal Half-life in Plasma (T1/2)|"Terminal half-life of the analyte in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||hours||Standard Deviation|Mean
1406175|NCT01211197|Secondary|Terminal Elimination Rate Constant in Plasma (λz)|"Terminal elimination rate constant in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||1/h||Standard Deviation|Mean
1406176|NCT01211197|Secondary|Time to Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum concentration of the analyte in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||hours||Full Range|Median
1406177|NCT01211197|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of metformin in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||ng/mL||Standard Deviation|Mean
1406178|NCT01211197|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||ng*h/mL||Standard Deviation|Mean
1406179|NCT01211197|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||ng*h/mL||Standard Deviation|Mean
1406180|NCT01211197|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||nmol*h/L||Standard Deviation|Mean
1406181|NCT01211197|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~Note the standard deviation is actually the CV."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||nmol/L||Standard Deviation|Mean
1406182|NCT01211197|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~Note the standard deviation is actually the coefficient of variation (CV)."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1 h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set included all evaluable subjects who took at least 1 dose of investigational medication, provided at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of pharmacokinetics.|||nmol*h/L||Standard Deviation|Mean
1406183|NCT01211184|Secondary|Muscle Catabolism|Assessed by the ratio of 3-methylhistidine/creatinine in excreted urine (unit: mmol/mmol).This is an amino acid unique to muscle that does not undergo intermediary metabolism, meaning that its urinary excretion is an index of the degree of muscle catabolism.|From the morning after surgery (07.30) up to the morning two days after sthe surgery (07.30)|Per protocol|||mmol/mmol||Standard Deviation|Mean
1406184|NCT01211184|Primary|Change in Insulin Sensitivity (Percent)|Insulin sensitivity (micro-mol per kg per minute glucose uptake) was calculated based on an intravenous glucose tolerance test (Theor Biol Med Model 2011, 8: 12) on the day before surgery. The percent change was taken as (day after - day before) / day before|Day before surgery (approximately 3 PM) and in the morning after surgery (approx. 7.30 AM).|Per protocol analysis. The study was powered to detect a difference in glucose clearance.|||percent change of insulin sensitivity||Inter-Quartile Range|Median
1406185|NCT01211145|Secondary|Use of Rescue Medication During the First 24 Hours After Treatment||24 hours post-treatment.|Full analysis set (observed cases)|||Participants|||Number
1406186|NCT01211145|Secondary|Sustained Headache Response at 2 Hours|Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.|Up to 2 hours post-treatment|Full analysis set (observed case)|||Participants|||Number
1406187|NCT01211145|Secondary|Headache Response at 24 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|24 hours post-treatment|Full analysis set (observed case)|||Participants|||Number
1406188|NCT01211145|Secondary|Headache Response at 2 Hours Post-treatment|Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.|2 hours post-treatment|Full analysis set (last observation carried forward)|||Participants|||Number
1406189|NCT01211145|Secondary|Pain-free Status at 24 Hours Post-treatment||24 hours post-treatment|Full analysis set (observed case)|||Participants|||Number
1406190|NCT01211145|Primary|Pain-free Status at 2 Hours Post-treatment||2 hours post-treatment.|Full analysis set (last observation carried forward)|||Participants|||Number
1406191|NCT01211106|Primary|Drinking Outcome|Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.|16 weeks|The number of subjects available for this measure are greater than the PTSD outcome as drinking outcomes can be obtained at anytime and thus some participants provided data at the post study evaluation.|||percent days ofheavy drinking||Standard Deviation|Mean
1406192|NCT01211106|Primary|PTSD Symptoms|PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1–5) scale, circling their responses. Responses range from 1 Not at All – 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.|16 weeks||||units on a scale||Standard Deviation|Mean
1406193|NCT01210820|Primary|Change in Keratometric Cylinder|Change in mean keratometric cylinder (as measured by keratometry) compared to baseline.|6 Months||||Diopters of astigmatism change||Standard Deviation|Mean
1406194|NCT01210820|Primary|Change in Refractive Astigmatism|Change in mean cylinder (assessed by manifest refraction) compared to baseline.|6 months||||Diopter of cylinder change||Standard Deviation|Mean
1406195|NCT01210807|Primary|Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm|Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.|4-6 Months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.|||logMAR visual acuity||Standard Deviation|Mean
1406196|NCT01210807|Secondary|Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity||4-6 months|Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.|||participants|||Number
1406197|NCT01210716|Secondary|Safety Measured by Adverse Events During the TPE Procedure||Adverse events were collected during each TPE procedure.|Adverse events were summarized for enrolled subjects per protocol. 7 out of 37 enrolled subjects experienced adverse events during the study with a total of 12 adverse events reported.|||participants|||Number
1406198|NCT01210716|Primary|Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure|"The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure.~Plasma Efficiency = (plasma removed/plasma processed)*100"|After completion of the TPE procedure.|A total of 37 patients who consented and enrolled started the 1st procedure. Of these 37 patients, 33 patients completed the 1st procedure and started a 2nd procedure. Three patients did not complete the second procedure resulting in 30 patients with completed paired Test and Control procedures.|||percentage of plasma removal efficiency||Full Range|Mean
1406199|NCT01210690|Secondary|Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period|Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment.|||participants|||Number
1406200|NCT01210690|Secondary|Global Evaluation Scale of Epilepsy Severity (GES)|"Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options:~7=Marked improvement~6=Moderate improvement~5=Slight improvement~4=No Change~3=Slight worsening~2=Moderate worsening~1=Marked worsening~As a variant of this variable, a 3-class variable was derived as follows~“Marked improvement,” “Moderate improvement,” and “Slight improvement” were defined as “Improved.”~“No change” was defined as “Stable.”~“Slight worsening,” “Moderate worsening,” and “Marked worsening” were defined as “Worsened.”"|From Baseline to the last Treatment Visit (maximum time frame is 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.|||participants|||Number
1406201|NCT01210690|Secondary|Global Evaluation Scale of the Psychomotor Development (GES)|"Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options:~7=Marked improvement~6=Moderate improvement~5=Slight improvement~4=No Change~3=Slight worsening~2=Moderate worsening~1=Marked worsening~As a variant of this variable, a 3-class variable was derived as follows~“Marked improvement,” “Moderate improvement,” and “Slight improvement” were defined as “Improved.”~“No change” was defined as “Stable.”~“Slight worsening,” “Moderate worsening,” and “Marked worsening” were defined as “Worsened.”"|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.|||participants|||Number
1406202|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit|The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.|From Baseline to the last Treatment Visit (maximum 12 months)|||||||
1406203|NCT01210690|Secondary|Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit|"Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs).~The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs."|From Baseline to the last Treatment Visit (maximum 12 months)|||||||
1406204|NCT01210690|Secondary|Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit|For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||z-scores||Standard Deviation|Mean
1406295|NCT01210001|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|"Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mg/dL||Standard Error|Mean
1406205|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit|For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.|From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||z-scores||Standard Deviation|Mean
1406206|NCT01210690|Secondary|Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit|For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.|From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||z-scores||Standard Deviation|Mean
1406207|NCT01210690|Secondary|Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit|Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months). The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient. The evaluation of the patient’s psychomotor development was categorized by the motor development, the social development and the language development.|From Baseline to the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication. Presented is the number of subjects with non-missing data on psychomotor development at the corresponding visit.|||participants|||Number
1406208|NCT01210690|Secondary|Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).|From Baseline through the last Treatment Visit (maximum 12 months)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||participants|||Number
1406209|NCT01210690|Secondary|Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up|Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||participants|||Number
1406210|NCT01210690|Primary|Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit|Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).|From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)|The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.|||participants|||Number
1406211|NCT01210664|Secondary|Hemoglobin A1c|Secondary diabetes-related outcome measure will include hemoglobin A1c|Up to 104 weeks|Population includes 14 participants treated|||% of HbA1c||Standard Deviation|Mean
1406212|NCT01210664|Secondary|Insulin Use|Secondary diabetes-related outcome measure will include insulin use|up to 104 weeks|Population includes 14 participants treated.|||U/day/kg||Standard Deviation|Mean
1406213|NCT01210664|Secondary|Percent Change From Baseline in C-peptide Area Under the Curve|Secondary diabetes-related outcome measure: C-peptide response during mixed meal tolerance test at 26 and 52 weeks, reported as the change from baseline in the area under the curve.|26 and 52 weeks from baseline|Population includes 14 participants treated.|||percentage change from baseline||Standard Deviation|Mean
1406214|NCT01210664|Primary|Number of Participants Experiencing Severe or Life Threatening Laboratory Abnormalities|"Laboratory measures tested include: hematology, blood chemistry, endocrine values, autoantibodies, and ophthalmologic exam results~Total number of participants experiencing severe or life-threatening laboratory abnormalities is reported for each cohort. Events reported include hyperglycemia and hypoglycemia."|Mean follow-up of 31 months|Safety analysis includes 14 treated participants who received one dose of PolyTregs at Day 0, two participants who underwent blood draw but did not receive PolyTregs were also included in the safety analysis.|||Participants|||Count of Participants
1406215|NCT01210664|Primary|Adverse Events (AEs) as a Measure of Safety and Tolerability|The number of AEs are reported by cohort and severity.|Mean follow-up of 31 months|Safety analysis includes 14 treated participants who received one dose of PolyTregs at Day 0, two participants who underwent blood draw but did not receive PolyTregs were also included in the safety analysis.|||adverse events|||Number
1406216|NCT01210651|Secondary|Total Change Scores on Rosenberg Self-Esteem Scale (RSES) Among Study Completers|The Rosenberg Self-Esteem Scale (RSES) is a 10-item, self-administered, validated psychometric instrument to measure self-esteem, defined as having an overall feeling of self-worth and self-acceptance. Each item is scored from 0 to 3, and individual item scores are summed to yield a total possible RSES ranging from 0-30. RSES scores from 0-14 suggest low self-esteem, from 15-25 normal self-esteem, and from 26-30 high self-esteem. RSES scores of study completers were examined, and the total change score on RSES was calculated for each intervention group as the mean RSES score at 0 wks subtracted from the mean RSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.|||points on a scale||Standard Deviation|Mean
1406217|NCT01210651|Secondary|Total Change Scores on General Self-Efficacy Scale (GSES) Among Study Completers|The General Self-Efficacy Scale (GSES) is a 10-item, self-administered, validated psychometric instrument to measure self-efficacy, defined as the belief that one’s actions are responsible for successful outcomes in coping with difficult life demands. Each item is scored from 1 to 4, with a total GSES score derived by summing the individual item scores. Possible GSES scores range from 10 (no belief in one's self-efficacy) to 40 (strongest belief in one’s self-efficacy). GSES scores of study completers were examined, and the total change score on GSES was calculated for each intervention group as the mean GSES score at 0 wks subtracted from the mean GSES score at 8 wks.|0 wks, 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention finish at 8 wks.|||points on a scale||Standard Deviation|Mean
1406218|NCT01210651|Primary|Number of Study Completers With Remitted Depression, Per Completers Analysis of BDI Scores at 8 Weeks|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Analysis examined BDI scores of study completers and identified in each intervention group the number of participants with an 8-wk BDI score ≤ 9, defined as remitted depression.|8 Weeks|Population of study completers with remitted depression was comprised of participants in both intervention groups who provided study measures at 0 wks and 8 wks, and achieved an 8-wk BDI score ≤ 9.|||participants|||Number
1406219|NCT01210651|Primary|Total Change Scores on Beck Depression Inventory-II Among Study Completers|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. BDI scores of study completers were examined, and the total change score on BDI was calculated for each intervention group as the mean BDI score at 0 wks subtracted from the mean BDI score at 8 wks.|0 wks and 8 wks|Population of study completers was comprised of participants in both intervention groups who provided study measures at intervention start at 0 wks and at intervention end at 8 wks.|||points on a scale||Standard Deviation|Mean
1406220|NCT01210651|Primary|Intent-to-Treat Analysis of Adjusted Mean Beck Depression Inventory-II Scores Over Intervention Period|The Beck Depression Inventory-II (BDI) is a 21-item validated instrument for the self-report of depressive symptoms, with individual item scores summed to yield a total possible BDI score that ranges from 0-63. BDI scores from 0-13 suggest absent to minimal depressive symptoms, from 14-19 mild symptoms, from 20-28 moderate symptoms, and from 29-63 severe symptoms. Regression analysis software examined the BDI scores measured in study participants every 2 wks from intervention start at 0 wks until intervention end at 8 wks, using maximum likelihood estimations to derive an adjusted mean BDI score for each intervention group at each measurement point.|0 wks, 2 wks, 4 wks, 6 wks, 8 wks|Intent-to-Treat population was comprised of all randomized participants in both intervention groups, regardless of adherence to protocol or premature dropout. BDI scores of any participants missing at 0 wks were imputed by carrying forward their BDI scores from screening.|||points on a scale||95% Confidence Interval|Least Squares Mean
1406221|NCT01210560|Secondary|Ranking of Treatment Tolerability.|Ranking of treatment tolerability was evaluated based on a questionnaire. At Day 22, participants were asked the following questions and their responses recorded on the eCRF: “Which treatment period did you find most tolerable?” and “Which treatment period did you find the least tolerable?”.|Day 22/Early Termination|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Participants|||Number
1406222|NCT01210560|Secondary|Change From Baseline in Urinary Frequency Questionnaire (Question 2 and Questions 3 to 10) at Day 6.|"Question 2 asked, “During the last 5 days, how much has urinary frequency bothered you?” In order to score the response, the written answers were assigned values from 0 to 4 as follows: 0) Not at all, 1) Somewhat, 2) Moderately, 3) Quite a bit, and 4) Constantly.~Question 3 to Question 10 were assigned scores of 0 to 4 with higher scores indicating worse cases in impact of urinary frequency on life; scores for these questions were pooled, with a maximum possible score of 32.~Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3."|Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Units on a scale||Standard Deviation|Mean
1406223|NCT01210560|Secondary|Number of Participants Experiencing Urinary Frequency Based on Urinary Frequency Questionnaire (Question 1) at Baseline and Day 6.|"The ADPKD Urinary Frequency Questionnaire: Question 1 (currently experiencing frequency) was assigned ‘Yes’ or ‘No’ to measure current urine frequency status.~Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3."|Baseline and Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Participants|||Number
1406224|NCT01210560|Secondary|Change From Baseline in Urinary Urgency Questionnaire (Questions 2 to 5 and Questions 7 to 14) at Day 6.|"Question 2 to Question 6 were assigned scores of 0 to 4 with higher scores indicating worse cases in experience of urinary urgency. Scores for Question 2 to Question 5 were pooled, with a maximum possible score of 16.~Question 6 was excluded from the analysis since it was only asked at screening. Question 7 to Question 14 were also assigned scores of 0 to 4 with higher scores indicating worse cases in impact of urinary urgency on life; scores for these questions were pooled, with a maximum possible score of 32.~Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3."|Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Units on a scale||Standard Deviation|Mean
1406225|NCT01210560|Secondary|Number of Participants Experiencing Urinary Urgency Based on Urinary Urgency Questionnaire (Question 1) at Baseline and Day 6.|For the ADPKD Urinary Urgency Questionnaire, Question 1 (currently experiencing urgency?) was assigned ‘Yes’ or ‘No’ to measure current urine urgency status. Baseline was defined as last pre-dose evaluation; Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3.|Baseline and Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Participants|||Number
1406226|NCT01210560|Secondary|Change From Baseline in Symptom Burden by Autosomal Dominant Polycystic Kidney Disease (ADPKD) Nocturia Quality of Life Questionnaire at Day 6.|In ADPKD Nocturia Quality of Life Questionnaire, questions 1 to 11 (with possible scores ranging from 0 to 4 and higher scores indicating better quality of life) were pooled to provide a total score (maximum of 44 points). Response scores of Question 12 (with possible scores ranging from 1 to 10, with higher scores indicating more interference (worse quality of life) with everyday life due to urination at night) were pooled separately. Day 6 was defined as Day 6 of Period 1, Day 13 of Period 2 and Day 20 of Period 3.|Day 6|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Units on a scale||Standard Deviation|Mean
1406227|NCT01210560|Secondary|Change From Baseline in Number of Urine Voids During Sleep Periods.|Average number of daily urine voids during sleep periods for each dose group. Day 1 was defined as Day 1 of Period 1, Day 8 of Period 2, Day 15 of Period 3; Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3; Same rule applied to Day 2 to 6.|Days 1, 2, 3, 4, 5, 6 and 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||Number of urine voids||Standard Deviation|Mean
1406228|NCT01210560|Secondary|Change From Baseline in Number of Urine Voids During Awake Periods.|Average number of daily urine voids during awake periods for each dose group. Day 1 was defined as Day1 of Period 1, Day 8 of Period 2 adn Day 15 of Period 3; Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3; Same rule applied to Day 2 and Day 6.|Days 1, 2, 3, 4, 5, 6 and 7|All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included.|||Number of urine voids||Standard Deviation|Mean
1406229|NCT01210560|Secondary|Duration of Urine Osmolality Less Than 300 mOsm/kg at Baseline and Day 7.|Duration of urine osmolality remains below 300 mOsm/kg was the sum of the durations (nominal times) of all intervals where the urine concentration was < 300 mOsm/kg. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2, and Day 21 of Period 3.|Baseline and Day 7|The duration that urine osmolality remained < 300 mOsm/kg was not calculated. Instead was calculated as the sum where urine osmolality was < 300 mOsm/kg in the 24-hour postdose period. The change was made because low doses of the MR formulation frequently do not produce suppression of urine osmolality in the 0- to 4-hour period.|||Hours||Full Range|Median
1406230|NCT01210560|Secondary|Change From Baseline in Urine Volume by Interval at Day 7.|Urine volume collected was by interval (0-4, 4-8, 8-12, 12-16, 16-24 hours). Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3.|0-4, 4-8, 8-12, 12-16, 16-24 Hours at Day 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||mL||Standard Deviation|Mean
1406231|NCT01210560|Secondary|Change From Baseline in Urine Volume at 24 Hours at Day 7.|Urine volume was collected by 0 to 24-hour interval at Day 7. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3.|Day 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||mL||Standard Deviation|Mean
1406232|NCT01210560|Secondary|Change From Baseline in Urine Osmolality at Day 7.|To determine the tolerability and nighttime urinary suppression of osmolality. The urine osmolality was summarized by collection interval (0 to 4, 4 to 8, 8 to 12, 12 to 16, and 16 to 24 hours)|0-4, 4-8, 8-12, 12-16, 16-24 Hours at Day 7|All participants who had taken study drug and have measurements of the pharmacodynamic endpoint were included.|||mOsm/kg||Standard Deviation|Mean
1406233|NCT01210560|Secondary|Change From Baseline in Urine Osmolality Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24h) at Day 7.|The AUC0-24h for urine osmolality was determined by multiplying the concentration by the collection interval duration for each collection interval and summing all the intervals in the 24-hour period. If the urine volume for an interval is zero, the duration of that interval will be added to the next collection interval. Day 7 was defined as Day 7 of Period 1, Day 14 of Period 2 and Day 21 of Period 3.|Day 7|All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included.|||mOsm/kg*Hour||Standard Deviation|Mean
1406234|NCT01210560|Secondary|Number of Participants With Urine Osmolality < 300 mOsm/kg at 23.5 Hours Postdose.|For determination of duration of urine osmolality <300 mOsm/kg, the value was the end time of the last collection interval in which urine osmolality was <300 mOsm/kg. Day 8 in the table below was defined as Day 8 of Period 1, Day 15 of Period 2, and Day 22 of period 3.|23.5 hours post-dose|All participants who had taken study drug and had measurements of the pharmacodynamic endpoint were included.|||Participants|||Count of Participants
1406235|NCT01210560|Primary|Area Under the Concentration-time Curve During the Dosing Interval at Steady State and Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUCT & AUC0-24h) After Tolvaptan Treatment on Day 7.|Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Hence, both AUCT and AUC0-24h values were calculated.|Day 7|Participants having valid measurements (per clinical pharmacology) were included.|||ng·h/mL||Standard Deviation|Mean
1406236|NCT01210560|Primary|Time to Maximum (Peak) Plasma Concentration (Tmax) After Tolvaptan Treatment on Day 7.|Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Time to maximum plasma concentration was calculated.|Day 7|Participants having valid measurements (per clinical pharmacology) were included.|||Hours||Full Range|Median
1406237|NCT01210560|Primary|Maximum (Peak) Plasma Concentration of the Drug [Cmax] and Minimum (Trough) Plasma Concentration of the Drug [Cmin] After Tolvaptan Treatment on Day 7.|Blood samples (6 mL) for determination of tolvaptan PK parameters were collected on Day 1 predose, and on Days 7, 14 and 21 at predose, and 1, 2, 4, 6, 8, 9, 10, 12, 16, and 24 hours postdose. If a sample was not drawn at the designated time, a window of ± 3 minutes for each blood draw was acceptable. Maximum and minimum plasma concentration of the drug was calculated.|Day 7|Participants having valid measurements (per clinical pharmacology) were included.|||ng/mL||Standard Deviation|Mean
1406238|NCT01210495|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) in Randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
1406239|NCT01210495|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) in Randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included all randomized participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
1406240|NCT01210495|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) in Non-Randomized Portion|Treatment-related AE was any untoward medical occurrence in a participant with causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The grade of an AE was determined according to CTCAE Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
1406241|NCT01210495|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) in Non-Randomized Portion|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. The grade of an AE was determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|Up to 28 days after last dose of study drug (up to 6 years)|The safety analysis population included participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||participants|||Number
1406242|NCT01210495|Secondary|Number of Participants With Dose-Limiting Toxicities (DLTs) in Non-Randomized Portion|Number of Child-Pugh Class B (score 7) participants with DLT was evaluated during Cycle 1 of treatment in the non-randomized portion of the study.|Cycle 1 (4 weeks)|Participants with Child-Pugh Class B, score 7 are only included in this analysis.|||participants|||Number
1406243|NCT01210495|Secondary|EuroQoL Visual Analogue Scale (EQ-VAS) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D VAS in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable). The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406244|NCT01210495|Secondary|EuroQoL (EQ-5D)- Health State Profile Utility Score in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406245|NCT01210495|Secondary|Time to Deterioration (TTD) Based on the Composite Endpoint in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|TTD analysis was performed for FHSI-8. Time to deterioration was defined as the time between date of randomization and date of the event.|From randomization to death or tumor progression or FHSI-8 mean score decrease >=3 points, whichever comes first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1406259|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic (PK) Parameter - Maximum Observed Plasma Concentration (Cmax), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1406246|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Trial Outcome Index (FACT Hep-TOI) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|The trial outcome index is defined to be the sum (PWB+FWB+HepCS), making it 32 items altogether. Each ranges from '0' – not at all to '4' - very much regarding how much each item was present in the last 7 days. FACT Hep –TOI total score ranges from 0 to 128, where the highest score represents a maximum achievable quality of life. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406247|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - Hepatobiliary Cancer Subscale (FACT Hep-CS18) Questionnaire in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|This subscale consists of 18 items rated on a scale from ‘0’ - not at all to ‘4’ - very much regarding how much each item was present in the last 7 days. FACT-Hep-CS18 total score ranges from 0 to 72. The higher score reflects better QoL or fewer symptoms. The 18 items of this scale are associated with hepatocellular carcinoma. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406248|NCT01210495|Secondary|Functional Assessment of Cancer Therapy-G (FACT-G) Subscales in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general HRQoL: PWB, SWB, EWB and FWB. Each of the individual subscale, except EWB has 7 items and each integer scored 0 to 4 making a maximum possible score of 28 (range 0 to 28). EWB has 6 items and each integer scored 0 to 4 making a maximum possible score of 24 (range 0 to 24). For all the 4 scales, higher values correspond to better health. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406249|NCT01210495|Secondary|Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary Symptom Index-8 (FHSI-8) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|The FACT-Hep includes the FACT-G and a hepatobiliary module. The hepatobiliary disease specific items include: swelling or cramps, losing weight, GI related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss, and jaundice) make up the FHSI-8, and are considered to be symptoms specific to hepatobiliary cancer. FHSI-8 total score ranges from 0 to 32 where “0” is a severely symptomatic participant and the highest score indicates an asymptomatic participant. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406250|NCT01210495|Secondary|Functional Assessment of Cancer Therapy - General (FACT-G) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate QoL in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): PWB, SWB, EWB and FWB; each ranging from 0 (not at all) to 4 (very much). FACT-G ranged between 0 and 108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. The below table included the model estimated average based on all the observed values/time points. The mixed effect model was used.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406260|NCT01210495|Secondary|Percentage of Participants With Overall Clinical Benefit Response (CBR) - Stratified Analysis, Randomized Portion|CBR was defined as the percentage of participants with confirmed CR or confirmed PR or a best response of stable disease >=8 weeks according to RECIST 1.1 criteria, relative to all randomized participants who had baseline measurable disease. Confirmed responses were defined as those that persisted on repeat imaging study >=4 weeks after the initial documentation of response. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed, or dropped out for any reason prior to reaching a CR, PR, or stable disease were counted as non-responders in the assessment of CBR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR was to be assigned a best response of CR.|From Baseline up to end of treatment|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||percentage of participants||95% Confidence Interval|Number
1406251|NCT01210495|Secondary|Functional Assessment of Cancer Therapy – Hepatobiliary Questionnaire (FACT-Hep) in Randomized Portion: Overall Between-Treatment Comparison Based on the Repeated Measures Mixed Effects Model|FACT-Hep consists of 27-item FACT-G, and 18-item Hepatobiliary Subscale. FACT-Hep questionnaire uses 5-point Likert rating scale, range '0'-not at all to '4'. FACT-Hep total score ranges from 0 to 180, where highest score represents maximum achievable quality of life. Domains of FACT-G include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Hepatobiliary disease specific items include: swelling or cramps, losing weight, gastrointestinal (GI)-related questions, lack of energy, side effects, pain, fatigue, usual activities, jaundice, fevers, itching, taste of food and chills. Eight of the items (pain, back pain, stomach pain/discomfort, lack of energy, fatigue, nausea, weight loss and jaundice) make up FACT-Hepatobiliary Symptom Index (FHSI-8), and are considered to be symptoms specific to hepatobiliary cancer. Table below included mixed effect model estimated average based on all observed values/time points.|Cycle 1 Day 1 pre-dose and before any other clinical assessments, every 4 weeks thereafter while on study, at end of study treatment/withdrawal, and follow-up and at Day 28 after last dose date|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||units on a scale||95% Confidence Interval|Least Squares Mean
1406252|NCT01210495|Secondary|Percentage of Participants With Specific Micro-Ribonucleic Acid (miRNA) Transcript Present in Circulation in Randomized Portion|A 5 millilitres (mL) whole blood sample was collected from all randomized participants to evaluate the miRNA transcripts.|Baseline|The miRNA analysis set included all participants in the safety analysis set who had a baseline miRNA assessment. Safety analysis population included all randomized participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.|||percentage of participants|||Number
1406253|NCT01210495|Secondary|Concentration of Soluble Proteins at Baseline in Randomized Portion|Plasma soluble proteins interleukin-6 (IL-6), E-Selectin, interleukin-8 (IL-8), hepatocyte growth factor (HGF), matrix metalloproteinase-2 (MMP-2), stem cell factor (SCF), angiopoietin-2 (Ang-2), vascular endothelial growth factor-A (VEGF-A), vascular endothelial growth factor-C (VEGF-C), soluble vascular endothelial growth factor receptor 2 (sVEGFR2), soluble vascular endothelial growth factor receptor 3 (sVEGFR3), stromal cell-derived factor-1 (SDF1), neutrophil gelatinase-associated lipocalin (NGAL), migration inhibitory factor (MIF), c-MET, regulated upon activation normal T cell expressed and presumably secreted (RANTES), and monocyte chemotactic protein-3 (MCP-3) were only measured in randomized participants.|Baseline|The soluble protein analysis set included all participants in the safety analysis set who had a Baseline soluble protein assessment. Safety analysis population included all randomized participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1406254|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Volume of Distribution of the Drug During the Elimination Phase (Vz/F), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. The PK parameter, Vz/F has been presented in this outcome measure. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||liters||95% Confidence Interval|Geometric Mean
1406255|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Terminal Plasma Elimination Half-Life (t1/2), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hours||Standard Deviation|Mean
1406256|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Apparent Oral Clearance (CL/F), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
1406257|NCT01210495|Secondary|Axitinib Steady-State Pharmacokinetic Parameter - Time to First Occurrence of Cmax (Tmax), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hours||Full Range|Median
1406258|NCT01210495|Secondary|Axitinib Steady-State PK Parameter - Area Under the Plasma Concentration Versus Time Curve From 0 to 24 Hour (AUC0-24), Non-Randomized Portion|Axitinib samples were to be collected from all participants on Cycle 1 Day 15 at the following time points: pre-dose, 1, 2, 3, 4, 6 and 8 hours after axitinib dosing. In the below table, 4 participants in Child-Pugh A and 1 participant in Child-Pugh B were not reported due to nonestimable half-life.|Cycle 1 Day 15|The PK concentration set included all participants who were treated and had at least 1 measured concentration on at least 1 day of PK assessment. The PK parameter analysis set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||nanograms*hour per milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
1406261|NCT01210495|Secondary|Duration of Response (DR) by Unstratified Analysis, Randomized Portion|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was to be used. DR (in months) was to be calculated as (the end date for DR − first CR or PR that was subsequently confirmed +1)/30.4.|From objective response to date of progression or death|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received. DR was calculated for the subgroup of FAS participants with objective response.|||months||95% Confidence Interval|Median
1406262|NCT01210495|Secondary|Time to Tumor Progression (TTP) - Stratified Analysis, Randomized Portion|TTP was defined as the time from randomization to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − first randomization date +1)/30.4.|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1406263|NCT01210495|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response by Stratified Analysis, Randomized Portion|ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the RECIST 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 millimetres [mm]). PR was defined as a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Every 8 weeks until at least two years after the last participant has been randomized|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||percentage of participants||95% Confidence Interval|Number
1406264|NCT01210495|Secondary|Progression-Free Survival (PFS) - Stratified Analysis, Randomized Portion|PFS was defined as time from randomization to first documented objective tumor progression or to death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date − first randomization date +1)/30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was death). As per response evaluation criteria in solid tumors (RECIST) 1.1, progression was defined as greater than or equal to (>=) 20% increase in sum of longest dimensions of target lesions or appearance of one or more new target lesions and unequivocal progression of existing non-target lesions, or appearance of 1 new non-target lesions. Participants discontinuing study treatment without documented evidence of PD were to be followed up at least every 8 weeks after discontinuing study treatment until disease progression, or initiation of another anticancer treatment.|Every 8 weeks until disease progression/death or start of new treatment or until at least two years after the last participant has been randomized, whatever occurs first|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1406265|NCT01210495|Primary|Overall Survival (OS) - Stratified Analysis, Randomized Portion|OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.|From randomization until at least two years after the last participant has been randomized (up to 6 years)|FAS included all randomized participants, and participants were classified according to the randomized treatment arm regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
1406266|NCT01210443|Secondary|Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in Blood Concentration of NT-pro BNP is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||pg/mL||Standard Deviation|Mean
1406267|NCT01210443|Secondary|Percentage of Participants With Change From Baseline in WHO Functional Class|The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. The change from baseline in WHO functional class is summarised with percentage of participants at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48).|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||Parcentage of participants|||Number
1406268|NCT01210443|Secondary|Change From Baseline in 6-Minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at each time point (every 12 weeks until Week 48 and every 24 weeks after Week 48) minus value at baseline.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||Meters||Standard Deviation|Mean
1406296|NCT01210001|Primary|HbA1c Change From Baseline|"Change From Baseline in HbA1c after 24 weeks.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
1406269|NCT01210443|Secondary|Percentage of Participants With Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|Up to 22 days (last participant discontinuation)|"The efficacy analysis set was defined as all subjects who receive at least one dose of study drug during this extension study and have efficacy observations at baseline of the preceding study (B1321052) in any efficacy assessments.~Descriptive statistics for any efficacy endpoints were not calculated due to a small number of participants."|||Percentage of participants|||Number
1406270|NCT01210443|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|Up to 22 days (last participant discontinuation)|The safety analysis set is defined as all subjects who receive at least one dose of study drug during this extension study.|||Participants|||Number
1406271|NCT01210222|Secondary|Progression-free Survival|The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Patients whose disease can be evaluated by physical exam, progression was assessed prior to each cycle. CT or MRI if used to follow leasion for measurable disease, up to 5 years|Eligible and treated patients|||Months||90% Confidence Interval|Median
1406272|NCT01210222|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years|Eligible and treated patients|||Months||90% Confidence Interval|Median
1406273|NCT01210222|Primary|Adverse Events as Assessed by NCI CTCAE v 4.0||Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
1406274|NCT01210222|Primary|Objective Tumor Response (Complete or Partial Response)|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1406275|NCT01210222|Primary|Progression-free Survival > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|At 6 months|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1406276|NCT01210170|Secondary|Albuterol Induced Percent Change in Qaw|Qaw will be measured before and 15 min after albuterol inhalation|change in Qaw 15 minutes after albuterol inhalation|As specified by the protocol, -60 minutes values were not to be analyzed if 200 mcg and 400 mcg of mometasone given 30 minutes before albuterol were determined to have no effect|||percent change in Qaw||Standard Error|Mean
1406277|NCT01210170|Primary|Albuterol-induced Change in FEV1|FEV1 will be measured before and after inhalation of 180 mcg albuterol.|15 minutes after albuterol inhalation|As specified by the protocol, -60 minutes values were not to be analyzed if 200 mcg and 400 mcg of mometasone given 30 minutes before albuterol were determined to have no effect|||liters||Standard Error|Mean
1406278|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants With Good or Poor Response to Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase). Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data for histological pattern of the endometrium in participants with good or poor response to Gonal-f were not summarized because the number of participants in each group with respect to ovarian response were too low.||||||
1406279|NCT01210144|Secondary|Gene Expression in Participants With Good or Poor Response to Gonal-f®|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent. Participants with poor response: 5 mature oocytes or less; participants with good response: more than 8 mature oocytes.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
1406280|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium in Participants Without Blastocyst Transfer|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day 5 or 6 (window of implantation) after Oocyte Retrieval|"ITT population: participants who received at least one dose of study medication. N (number of participants analyzed) signifies participants who were evaluable for this measure. Data were not analyzed for Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol) group because there were no participants without blastocyst transfer in this group."|||participants|||Number
1406281|NCT01210144|Secondary|Gene Expression in Participants Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day 5 or 6 (window of implantation) after Oocyte Retrieval|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
1406282|NCT01210144|Secondary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f® and Having Undergone Agonist or Antagonist Protocol|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle), Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"ITT population included those participants who received at least one dose of study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||participants|||Number
1406283|NCT01210144|Secondary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f® in Participants Having Undergone Agonist or Antagonist Protocol|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
1406284|NCT01210144|Secondary|Gene Expression of the Endometrium in Participants With or Without Blastocyst Transfer|A list of genes based on gene expression profiling carried out on RNA extracted from endometrial tissue. The expression of mRNA in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed because gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
1406285|NCT01210144|Primary|Number of Participants With a Specific Histological Pattern of the Endometrium Following 1 Cycle With Gonal-f®|Participants with each histological pattern of endometrium were analyzed. Histological patterns included: Proliferative phase (described as the endometrial on the first two weeks after the menstruation [or before ovulation]), Early secretory phase (first step of the secretory phase, located at the Day 16-18 of the cycle) and Intermediate secretory phase (secretory phase located at the Day 20-22 of the cycle and describes endometrial closer to the implantation phase).|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|"Intention-to-Treat (ITT) population: participants who received at least 1 dose of study drug. N (number of participants analyzed) signifies participants evaluable for this measure. Results for both agonist and antagonist protocol are presented as total since assessment of histological pattern for whole study population was the primary objective."|||participants|||Number
1406286|NCT01210144|Primary|Gene Expression of the Endometrium Following 1 Cycle With Gonal-f®|A list of genes based on gene expression profiling carried out on ribonucleic acid (RNA) extracted from endometrial tissue. The expression of messenger ribonucleic acid (mRNA) in endometrial tissue was measured by using microarrays such as the Affymetrix® GeneChip HG-U133 plus 2.0 array or equivalent.|Day of Oocyte Retrieval (36 +/- 2 hours post r-hCG administration) after COS by Gonal-f®|Data were not analyzed for both agonist and antagonist protocol as total, which was the primary objective, since gene expression of the endometrium could not be performed due to poor quality of biopsy samples and poor recruitment in the study.||||||
1406287|NCT01210118|Secondary|Days of Prematurity of Birth|Days of prematurity of birth were recorded|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.|||number of days||Standard Deviation|Mean
1406288|NCT01210118|Primary|The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.|The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.|At the baseline and at the 32nd week of gestation||||percentage of participants who quit|||Number
1406289|NCT01210118|Secondary|Birth Weight|Infants' birth weight was recorded.|After child birth|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.|||birth weight in grams||Standard Deviation|Mean
1406290|NCT01210118|Primary|Participants' Smoking Status|participants' smoking status was validated by urine cotinine and urine nicotine|around the 32nd week of gestation.|Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis|||ng/ml||Standard Deviation|Mean
1406291|NCT01210079|Primary|Change in Pain Threshold Time From Baseline to Week 5|Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.|baseline, 5 weeks||||seconds||Standard Error|Mean
1406292|NCT01210001|Other Pre-specified|Hypoglycaemic Events|Number of patients with hypoglycaemic events, as reported as adverse events.|From first drug administration until 7 days after last intake of study drug, up to 256 days|Treated set which included all patients treated with at least one dose of randomised study medication|||percentage of participants|||Number
1406293|NCT01210001|Primary|HbA1c Change From Baseline for Pio and Met Background Medication Patients|"Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value for patients on pioglitazone and metformin background medication. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
1406294|NCT01210001|Secondary|Body Weight Change From Baseline|"Change from baseline in body weight after 24 weeks.~Note that adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||kg||Standard Error|Mean
1406297|NCT01209949|Secondary|Number of Participants With Tolerability Assessments Resulting in an Adverse Event|Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst.|12 weeks|Safety|||participants|||Number
1406298|NCT01209949|Secondary|Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12.|Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12.|Week 12|Modified ITT (subjects with a baseline and week 12 visit)|||percent change from baseline||Standard Deviation|Mean
1406299|NCT01209949|Primary|Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12|Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst.|12 weeks|Modified ITT (subjects with a baseline and week 12 visit)|||participants|||Number
1406300|NCT01209780|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.|Day 1 to 180 (non-naive )/Day 1 to 209 (naive)|Analysis was done on the safety set population.|||Subjects|||Number
1406301|NCT01209780|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine|The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.|Day 1 to 7 after vaccination|Analysis was done on the safety set population i.e all subjects who received at least one study vaccine and provided post vaccination safety data.|||Subjects|||Number
1406302|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).~This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain."|Day 29 and Day 50|Analysis was done on the per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1406303|NCT01209780|Secondary|Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.|"The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).~This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain."|Day 1, Day 29, and Day 50|Analysis was done on the per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1406304|NCT01209780|Secondary|Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine|"The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.~This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40."|Day 22 for non-naive/Day 50 for naive|Analysis was performed on the per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1406305|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)|The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on the per protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1406306|NCT01209780|Secondary|Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.|"The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.~This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%."|Day 22 for non-naive/Day 50 for naive subjects|Analysis was performed on per protocol population.|||Percentages of subjects||95% Confidence Interval|Number
1406307|NCT01209780|Primary|Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion|"The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.~Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer"|Day 22 for non-naive/Day 50 for naive subjects|Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.|||Percentages||95% Confidence Interval|Number
1406319|NCT01209702|Secondary|Part 2: Peak Plasma Concentration of Tocilizumab|The peak plasma concentration (Cmax) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
1406308|NCT01209767|Primary|Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.|"Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom Cryolipolysis or Subcision resulted in the best cosmetic appearance. It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better."|12 weeks||||Percentage of participants||90% Confidence Interval|Number
1406309|NCT01209702|Secondary|Part 1: The Number of Participants With Adverse Events|A serious adverse event (AE) is any event that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one or other of the outcomes listed above. The intensity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.02. A severe AE was any event of Grade 4 (life-threatening consequences; urgent intervention indicated) or 5 (death related to AE).|Up to 40 weeks|The safety analysis population included all patients who received at least one tocilizumab/placebo infusion and had at least one postdose safety assessment. Patients were assigned to treatment groups as treated for analysis.|||participants|||Number
1406310|NCT01209702|Secondary|Part 2: Percentage of Participants With a Reduction of Magnetic Resonance Imaging (MRI) Proven Spinal Inflammation|Magentic resonance imaging of the axial skeleton was to be performed at Baseline and Week 24. MRI scans will be evaluated using the ankylosing spondylitis spinal MRI activity (ASspiMRI-a) score, grading activity (0-6) per vertebral unit in 23 units.|Baseline and Week 24|Due to premature study termination this outcome measure was not analyzed.||||||
1406311|NCT01209702|Secondary|Part 2: Radiographic Change According to the Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)|"Radiographs were to be assessed using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where:~0 = No abnormality;~1 = Erosion, sclerosis, or squaring;~2 = Syndesmophyte;~3 = Total bony bridging at each site."|Baseline and Week 104|This outcome measure was not analyzed due to premature study termination.||||||
1406312|NCT01209702|Primary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.|||percentage of participants|||Number
1406313|NCT01209702|Secondary|Number of Participants With Anti-tocilizumab Antibodies|A positive anti-tocilizumab antibody result was defined as a negative assay result at Baseline and a positive post-baseline screening assay with positive confirmation or neutralizing assay at the same visit.|From Baseline until end of study (a maximum treatment duration of 40 weeks).|All patients treated with tocilizumab and screened for anti-tocilizumab antibodies at any timepoint.|||participants|||Number
1406314|NCT01209702|Secondary|Change From Baseline in Level of Soluble Interleukin-6 Receptor|"Soluble Interleukin-6 receptor levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.~The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic Population: All patients who received at least one tocilizumab infusion and had at least one pharmacokinetic and pharmacodynamic sample. Only those patients with available data at each time point are included in the analysis (indicated by N). Patients who did not receive their week 8 dose were excluded.|||ng/mL||Standard Deviation|Mean
1406315|NCT01209702|Secondary|Change From Baseline in the Level of Interleukin-6|"Interleukin-6 levels were measured from blood samples taken pre-dose at Baseline and after 12 weeks of treatment.~The analysis was not performed for participants in Part 2 due to premature study termination."|Baseline and Week 12|Pharmacokinetic (PK) Population: All patients who received at least one tocilizumab infusion and had at least one PK and pharmacodynamic sample. Only patients with available data at each time point are included (indicated by N). Patients who did not receive their Week 8 dose were excluded.|||pg/mL||Standard Deviation|Mean
1406316|NCT01209702|Secondary|Part 2: Volume of Distribution of Tocilizumab|Volume of distribution of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
1406317|NCT01209702|Secondary|Part 2: Clearance of Tocilizumab|Clearance of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
1406318|NCT01209702|Secondary|Part 2: Elimination Half-life of Tocilizumab|Elimination half-life of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
1406320|NCT01209702|Secondary|Part 2: Area Under the Plasma Concentration Versus Time Curve of Tocilizumab|Area under the plasma concentration versus time curve (AUC) of tocilizumab at steady state after 12 weeks of treatment.|Week 12, pre-dose and at the end of infusion, on the 2nd and 7th day of Week 12, 14 days post-dose (Week 14) and 28 days post-dose (pre-dose of Week 16 infusion).|Due to premature study termination pharmacokinetic parameters were not analyzed.||||||
1406321|NCT01209702|Secondary|Change From Baseline in C-Reactive Protein|Levels of C-reactive protein (CRP) were measured from blood samples taken at Baseline and at Week 12.|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.|||mg/dL||Standard Deviation|Mean
1406322|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|"The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are:~Tragus-to-wall;~Modified Schober (lumbar flexion);~Cervical rotation;~Lateral spinal flexion;~Intermalleolar distance.~The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient’s limitation of movement due to their AS."|Baseline and Week 12|Intent-to-treat population where data were available. The analysis was not performed for participants in Part 2 due to premature study termination.|||scores on a scale||Standard Deviation|Mean
1406323|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|The Bath Ankylosing Spondylitis Functional Index (BASFI) is an assessment of function in AS patients. The participant provides their assessment of their ability to perform 10 activities on a 100 mm horizontal visual analog scale (VAS) ranging from 0 (easy) to 100 (impossible). The BASFI score is the mean of these values and is tabulated on a 0 (best) to 10 (worst) cm scale.|Baseline and Week 12|Intent-to-treat population for whom data were available. The analysis was not performed for participants in Part 2.|||cm||Standard Deviation|Mean
1406324|NCT01209702|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|"The BASDAI is a patient-administered assessment of 6 parameters specific to AS. The following parameters were assessed on a 100-mm horizontal visual analogue: fatigue, spinal pain, peripheral arthritis, enthesitis, intensity of morning stiffness, and duration of morning stiffness. For questions 1 to 5, the left-hand extreme of the line (0) represents none (symptom-free) and the right-hand extreme (100) represents very severe (maximum severity). For question 6, a time axis was used, with the left-hand extreme of the line representing 0 hours and the right-hand extreme representing 2 or more hours. The BASDAI score was calculated as follows:~BASDAI = [Q1 + Q2 + Q3 + Q4 + (Q5 + Q6)/2]/5. The total score is tabulated on a scale from 0 (best) to 10 cm (worst)."|Baseline and Week 12|Intent-to-treat population where data were available.|||cm||Standard Deviation|Mean
1406325|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 24|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT), Part 2 study population. This analysis was not performed due to premature study termination.||||||
1406326|NCT01209702|Secondary|Percentage of Participants Achieving a 40% Improvement in Assessment in Ankylosing Spondylitis (ASAS40) at Week 12|"ASAS is composed of four domains. To achieve an ASAS40 response required improvement of ≥40% and ≥ 2 units (20 mm) in at least 3 domains and no worsening at all in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|Intent-to-treat (ITT) population. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.|||percentage of participants|||Number
1406327|NCT01209702|Secondary|Percentage of Participants Who Achieved a Value <2 in Each of the 4 ASAS Parameters at Week 12|"Assessment in Ankylosing Spondylitis (ASAS) is composed of four domains.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI), the mean of 10 self-assessment questions on a 100 mm VAS.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).~Each of the above 4 domains are measured on a scale from 0-100 mm, but reported on a 0-10 cm scale. A score of less than 2 units (20 mm) in each domain is defined as partial remission."|Week 12|Intent-to-treat. If the response at the Week 12 visit could not be determined due to early withdrawal or missing data then the patient is considered a non-responder. The analysis was not performed for participants in Part 2 due to premature study termination.|||percentage of participants|||Number
1406328|NCT01209702|Secondary|Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 24|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient's overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 24|Intent-to-treat (ITT) population. The analysis only includes assessments while the patient was receiving double blind medication, and occurred prior to both withdrawal and the 15 July 2011 (date at which all patients were unblinded). Patients who withdrew or escaped are considered as non-responders until week 24.|||percentage of participants|||Number
1406329|NCT01209702|Primary|Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12|"ASAS is composed of four domains. To achieve an ASAS20 response required improvement of ≥20% and ≥ 1 unit (10 mm) in at least 3 domains and no worsening of ≥ 20 % and ≥ 1 unit (10 mm) in the remaining domain.~The patient's global assessment of current disease status, measured on a 100 mm visual analog scale (VAS), from symptom-free / no AS symptoms (0) to maximum AS disease severity (100).~The patient’s overall assessment of the severity of spinal pain based on responses to 2 questions assessed on a 100 mm VAS, from no pain (0) to most severe pain (100). The spinal pain score is the mean of these 2 questions.~The function component was measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The patient provides self-assessment of 10 questions on a 100 mm VAS. The BASFI score is the mean of these values.~The inflammation component of the ASAS was determined by the mean of questions 5 and 6 of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)."|Baseline and Week 12|"Intent-to-treat (ITT) population included all patients who were randomized into the study and received at least one tocilizumab/placebo infusion.~If the response at the 12-week visit could not be determined due to early withdrawal or missing data then the patient was considered a non-responder."|||percentage of participants|||Number
1406330|NCT01209689|Primary|Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12|ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index [BASFI] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index [BASDAI] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.|Baseline to Week 12|Intent-to-treat population: All randomized patients who received at least 1 dose of treatment. The analysis only included assessments while patients were receiving double-blind treatment and that occurred prior to withdrawal or the date when all patients were unblinded (15 Jul 2011). Patients who withdrew or escaped were considered non-responders.|||Percentage of patients|||Number
1406331|NCT01209624|Primary|Percentage of Participants With Progression of Visual Field|Progression defined as visual field deterioration rated progressive by physician on at least 1 post-baseline visit, and increase in Aulhorn stage (by at least 1 stage) and/or decrease in mean defect by at least 2.5 dB (Last Visit minus Baseline).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have had Visual Field Deterioration rated as progressive by the physician on at least 1 post-baseline visit, and at least one measure of increase in Aulhorn Stage by at least 1 stage, and decrease in Mean Defect by at least 2 dB (last visit minus baseline).|||Percentage of Participants|||Number
1406332|NCT01209624|Primary|Percentage of Participants With Progression of Optic Disc Excavation|Progression (Last Visit minus Baseline) defined as increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2, and/or decrease in at least 1 of Heidelberg Retina Tomograph (HRT) parameters (deterioration of rim area 0.2 mm2; deterioration of rim volume 0.1 mm3 deterioration or mean retinal nerve fiber layer (RNFL) thickness 0.1 mm).|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of following events: increase in horizontal or vertical cup to disc ratio, or decrease in rim area, rim volume, or mean RNFL thickness. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Percentage of Participants|||Number
1406333|NCT01209624|Primary|Percentage of Participants With Overall Progression of Glaucoma Damage|Overall progression defined as at least 1 of the 6 individual progression of glaucoma damage measures met: increase in horizontal cup to disc ratio and/or vertical cup to disc ratio by at least 0.2; at least 1 post Baseline (BL) optic-disc hemorrhage; decreased rim area (0.2 mm2), rim volume (0.1 mm3), mean retinal nerve fiber layer (RNFL)(0.1 mm), progressive visual field deterioration, increase in Aulhorn stage (by at least 1 stage), and/or decrease in mean defect by at least 2.5 decibels [dB])|Month 24 (or last visit)|PP; to be included in the percentage, participants must have provided a response for at least one of the six individual progression of glaucoma damage measures. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Percentage of Participants|||Number
1406334|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Mean Defect|Decrease in mean defect by at least 2.5 decibels (dB) (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value for mean defect at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
1406335|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Aulhorn Stage|Increase in Aulhorn Stage by at least one stage (last visit minus baseline). Three different visual field defect categories defined using Aulhorn stage values 1-5: Aulhorn stage 1 = mild damage, Aulhorn stages 2, 3 = moderate damage, Aulhorn stages 4, 5 =severe damage.|Month 24 (or last visit)|PP; results based on participants with a value for Aulhorn Stage at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
1406336|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Visual Field Defect-Deterioration|Visual Field Deterioration rated as progressive by physician on at least one post-baseline visit; range: 1= improved 2= stable 3= progressive. If both eyes were treated with Xalatan® the value for the right eye was used; otherwise, only the assessment for the eye treated with study medication was used.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of change in visual field defect. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
1406337|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Rim Area, Rim Volume, or Mean Retinal Nerve Fiber Layer (RNFL) Thickness|Decrease in at least one Heidelberg Retina Tomograph (HRT) parameter by: Rim Area 0.2 millimeter (mm)2, Rim Volume 0.1 mm3, or mean retinal nerve fiber layer (RNFL) Thickness 0.1 mm, (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with a value of the variable in question at both Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
1406338|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Optic Disc Hemorrhage|Participants with at least one post-baseline optic disc hemorrhage.|Month 24 (or last visit)|PP; results based on participants with at least one post-baseline assessment of optic disc hemorrhage. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Particpants|||Number
1406339|NCT01209624|Primary|Number of Participants With Individual Progression of Glaucoma Damage: Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio|Increase in Horizontal Cup to Disc Ratio and/or Vertical Cup to Disc Ratio by at least 0.2 (Last Visit minus Baseline).|Month 24 (or last visit)|PP; results based on participants with both a Baseline and at least one post-baseline visit. Last Visit = last post-baseline visit at which participant provides a value for the relevant outcome measure.|||Participants|||Number
1406340|NCT01209624|Primary|Number of Participants With Investigator Assessments of Efficacy at Month 24|Number of participants with Investigator assessments of the efficacy of Xalatan® treatment rated as: 1=very good, 2=good, 3=moderate, 4=insufficient. If study medication was stopped before 24 months, assessment was performed at the time of early termination.|Month 24|PP; N = number of participants with a non-missing response at Month 24 visit.|||Participants|||Number
1406341|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Visual Field Defect|Change in mean defect right and left eye; valid range: -30 - + 30 decibels (dB). Visual field defect categories: preperimetric glaucoma: ≥ -2 dB; mild damage: < -2 dB and ≥ -3.3 dB; moderate damage: < -3.3 dB and ≥ -4.6 dB; and severe damage: < -4.6 dB. If both eyes were treated with Xalatan® , the value for the right eye was used; otherwise, only the mean defect value for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided a Mean Defect value at both Baseline and Month 24 visits.|||Participants|||Number
1406342|NCT01209624|Primary|Number of Participants With Change From Baseline to Month 24 in Aulhorn Stages|Values of change in Aulhorn Stage measured by Humphrey Visual Field Analyzer. Aulhorn stages: no scotoma, Stage I (relative scotomas only), Stage II (absolute scotomas without connection to blind spot), Stage III (absolute scotomas with connection to blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If both eyes were treated with Xalantan® the value of right eye was analyzed; otherwise, only the assessment for the eye treated with study medication was used.|Baseline, Month 24|PP; N = number of participants who provided Aulhorn stage values of 1 to 5 at both baseline and month 24 visits.|||Participants|||Number
1406343|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Mean RNFL Thickness|Mean retinal nerve fiber layer (RNFL) thickness in millimeters (mm) right and left eye assessed by HRT imaging. Valid range: 0.100 to 0.400 mm. Only the RNFL for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for RNFL thickness.|||mm||Standard Deviation|Mean
1406344|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph Parameters: Cup Shape Measure|Cup shape measure right and left eye assessed by HRT imaging . Valid range: -0.400 to -0.010. Only the cup shape measure for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for cup shape measure.|||Cup shape measure||Standard Deviation|Mean
1406345|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Volume|Rim volume (mm3) right and left eye assessed by HRT imaging. Valid range: 0.080 to 0.700 mm3. Only the rim volume for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim volume.|||mm3||Standard Deviation|Mean
1406346|NCT01209624|Primary|Change From Baseline in Heidelberg Retina Tomograph (HRT) Parameters: Rim Area|Rim area (millimeter [mm]2) right and left eye assessed by HRT imaging. Valid range: 0.500 to 1.900 mm2. Only the rim area for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; n = number of participants with a non-missing response at both visits (baseline and observation). Last Visit = last post-baseline visit at which participant provides a value for rim area.|||mm2||Standard Deviation|Mean
1406348|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 18|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 18|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
1406349|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 12|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 12|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
1406350|NCT01209624|Primary|Number of Participants With Optic Disc Hemorrhage by Visit: Month 6|Presence of optic disc hemorrhages assessed by slip lamp examination. Only data for eye were treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Month 6|PP; N = number of participants who indicated whether or not they had an optic disc hemorrhage at the given visit.|||Participants|||Number
1406351|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0; a high cup/disc ratio may imply glaucoma. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP. N = number of participants with vertical cup to disc ratio at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in vertical cup to disc ratio in participants with a non-missing response at both baseline and at least one post-baseline visit.|||Ratio||Standard Deviation|Mean
1406352|NCT01209624|Primary|Change From Baseline by Visit in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio measured by slit lamp examination to assess progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). Valid range: 0.1-1.0. Only data for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|PP; N = number of participants with horizontal cup to disc ratio data at baseline and at least 1 post-baseline visit; change analyzed for participants with a non-missing response at baseline and observation. Last Visit: change in participants with a non-missing response at both baseline and at least one post-baseline visit.|||Ratio||Standard Deviation|Mean
1406353|NCT01209624|Primary|Percentage of Participants Who Achieved Intraocular Pressure (IOP) Target at Last Visit|Percentage of participants who achieved their IOP target set at baseline. Response: Yes = achieved IOP target at last vist; No = did not achieve IOP target at last visit.|Month 24, (or last visit)|PP; n = number of subjects in the Per Protocol Analysis Set with a non-missing response at Last Visit. Last visit = last post-baseline visit at which participant provides a value of IOP.|||Percentage of Participants|||Number
1406354|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 24|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 24|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.|||Participants|||Number
1406355|NCT01209624|Primary|Number of Participants Per Visit With Intraocular Pressure (IOP) 24-Hour Pressure Peaks: Month 12|Response: Yes = had IOP 24-hour pressure peak; No = did not have IOP 24-hour pressure peak.|Month 12|PP; N = number of participants with analyzable data at observation. The total number of participants by visit with an IOP peak response of ‘Yes’ differs from those with numerical values of IOP peaks since 1 of the 2 fields was populated for certain participants.|||Participants|||Number
1406356|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 24|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 24|PP; N = number of participants with analyzable data at observation.|||Participants|||Number
1406357|NCT01209624|Primary|Number of Participants With a 24-Hour Intraocular Pressure (IOP) Profile: Month 12|Response: Yes = had an IOP 24-hour profile; No = did not have an IOP 24-hour profile.|Month 12|PP; N = number of participants with analyzable data at observation.|||Participants|||Number
1406358|NCT01209624|Primary|Change From Baseline in Raw Intraocular Pressure (IOP) by Visit|Mean IOP values measured by applanation tonometry or noncontact method; valid range: 8-40 millimeters of mercury (mmHg). Only the IOP reading for the eye treated with Xalatan® was used; if both eyes were treated, the value of the right eye was analyzed. Last visit = last post-baseline visit at which participant provides a value of IOP.|Baseline, Month 6, Month 12, Month 18, Month 24, Last Visit|Per protocol (PP) analysis set: all participants in the Full Analysis Set (at least 1 dose of Xalatan® and 1 post-baseline IOP measurement) who were treated for ≥18 months; had at least BL and 1 post-BL non-missing efficacy assessments for IOP at least 18 months apart; without ametropy at BL; and without additional glaucoma medication during study.|||mmHg||Standard Deviation|Mean
1406359|NCT01209598|Secondary|Best Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years||||Participants|||Count of Participants
1406360|NCT01209598|Primary|Progression Free Survival at 12 Weeks|PFS, defined as RECIST 1.1 (CR + PR + SD) when treated with Palbociclib|12 weeks||||percentage of particpants||95% Confidence Interval|Median
1406361|NCT01209520|Primary|Degree of Demethylation in Patient Tumor Tissue and/or Serum Induced by 5-azacitidine on Specific Tumor Specific Genes (TSGs)|To measure the grade of demethylation induced by 5-azaciditine on specific TSGs by analyzing plasma DNA, and global demethylation by analyzing WBC DNA, and determine the duration of this effect.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.||||||
1406362|NCT01209520|Primary|Percentage of Patients Showing a Presence of Methylated Tumor Suppressor Genes in Their Tumor Tissue and/or Serum Achieving Partial or Complete Response to Protocol Therapy.|To determine the feasibility and efficacy of incorporating a demethylating agent (5-azacitidine; Vidaza®, Celgene, Summit, NJ, USA) as part of adjuvant therapy in patients diagnosed with NSCLC who harbor methylated tumor supressor genes (TSGs) in their tumor tissue and/or serum. Response to be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.0.|Up to 2 years|Study data were not analyzed due to insufficient number of evaluable patients.||||||
1406363|NCT01209286|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) is 125 pg/mL and the limit of detection (LOD) is 20 pg/mL.|Samples were collected prior to treatment start (baseline), and at 2, 6, 24, and 48 hours after drug infusion start, and at these same time points when dose is escalated in each treatment cycle.|Participants who received blinatumomab and who had evaluable pharmacodynamic data.|||pg/mL||Standard Deviation|Mean
1406364|NCT01209286|Secondary|Clearance of Blinatumomab|Clearance was calculated as R0/Css; where R0 is the infusion rate (μg/m^2/hr) and Css is the steady state concentration.|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.|||L/m^2/hr||Standard Deviation|Mean
1406365|NCT01209286|Secondary|Steady State Blinatumomab Concentration|"The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the intravenous infusion was started for cycle 1 and cycle 2, respectively. Actual doses administered were used in the analysis.~Concentrations below the limit of detection (3 pg/mL) were set to zero before data analysis and concentrations below the lower limit of quantitation (50 pg/mL) were excluded from analysis."|Samples were collected at predose and at 48 hours following start of infusion, when dose is escalated and on Days 8, 15, 22, and 29 of the first 2 cycles.|Participants who received blinatumomab and who had available pharmacokinetic data.|||pg/mL||Standard Deviation|Mean
1406366|NCT01209286|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 and according to the following:~Grade I (mild); Grade 2 (moderate); Grade 3 (severe - significantly limits the patient's ability to perform routine activities despite symptomatic therapy; Grade 4 (life-threatening); Grade 5 (death).~The investigator used medical judgment to determine if there was a causal relationship (ie, certain, probable, possible, unlikely, not related) between an adverse event and blinatumomab.~A serious adverse event is any untoward medical occurrence or effect, that at any dose:~resulted in death, was life-threatening, required or prolonged hospitalization, resulted in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically important condition."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle; median treatment duration was 55.7 days.|Safety analysis set, defined as all participants who received any infusion of blinatumomab.|||participants|||Number
1406367|NCT01209286|Secondary|Overall Survival|Overall survival was measured for all participants from the date of first infusion of blinatumomab until the date of death due to any cause. Participants who did not die were censored on the last documented visit date. Overall survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 667 days.|Full analysis set|||days||95% Confidence Interval|Median
1406368|NCT01209286|Secondary|Relapse-free Survival|Relapse-free survival was measured only for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Relapse-free survival was estimated using Kaplan-Meier methods.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.|||days||95% Confidence Interval|Median
1406369|NCT01209286|Secondary|Time to Hematological Relapse|"Time to hematological relapse was measured for participants who achieved a CR or CRh* during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their day of death.~Hematological Relapse was defined as:~Proportion of blasts in bone marrow > 5%~Extramedullary relapse.~Time to hematological relapse was analyzed by Kaplan-Meier methods."|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.|||days||95% Confidence Interval|Median
1406370|NCT01209286|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) After Treatment With Blinatumomab|The percentage of participants who underwent immediate allogeneic HSCT (defined as those in remission who undergo HSCT without receiving any other treatments) after having discontinued or completed the core study.|Up to the data cut-off date of 15 October 2012; maximum follow up time was 459 days|Full analysis set|||percentage of participants|||Number
1406371|NCT01209286|Secondary|Percentage of Participants With a Minimal Residual Disease (MRD) Response During the Core Study|A minimal residual disease (MRD) response is defined as MRD < 10^-4 blasts/nucleated cells based on polymerase chain reaction (PCR) evaluation of individual rearrangements of immunoglobulin or T cell receptor genes.|During the core study treatment period (up to 30 weeks).|Full analysis set (FAS)|||percentage of participants||95% Confidence Interval|Number
1406372|NCT01209286|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Partial remission was defined by the following criteria:~• Bone marrow blasts ≤ 25%"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1406373|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete remission with only partial hematological recovery (CRh*) was defined by the following criteria:~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Partial recovery of peripheral blood counts:~Platelets > 50,000/μL~Hemoglobin ≥ 7 g/dL~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1406374|NCT01209286|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Complete Response/Remission (CR) was defined by the following criteria:~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Full recovery of peripheral blood counts:~Platelets > 100,000/μL~Hemoglobin ≥ 11 g/dL~Absolute neutrophil count (ANC) > 1,500/μL"|Within the first 2 cycles of treatment, 12 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1406375|NCT01209286|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"At the end of each infusion period, a bone marrow aspiration/biopsy was performed to evaluate the efficacy of blinatumomab. All hematological assessments of bone marrow were reviewed in a central reference laboratory. Hematological remissions were defined by the following criteria:~Complete Response/Remission (CR):~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Full recovery of peripheral blood counts:~Platelets > 100,000/μL~Hemoglobin ≥ 11 g/dL~Absolute neutrophil count (ANC) > 1,500/μL~Complete Remission with only Partial Hematological Recovery (CRh*):~Less than or equal to 5% blasts in the bone marrow~No evidence of circulating blasts or extramedullar disease~Partial recovery of peripheral blood counts:~Platelets > 50,000/μL~Hemoglobin ≥ 7 g/dL~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Full analysis set (FAS), defined as participants who received any infusion of the assigned study medication, who completed at least the first treatment cycle and for whom at least one response assessment was available after the start of treatment.|||percentage of participants||95% Confidence Interval|Number
1406376|NCT01209260|Secondary|Plastic Dilator Shavings|In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.|immediately prior to procedure|The assigned needle for each participant was analyzed prior to the procedure|||Needles|Participants||Number
1406377|NCT01209260|Secondary|Performance of the Assigned Needle Type|Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.|at time of procedure||||participants|||Number
1406378|NCT01209260|Secondary|Number of Participants With Adverse Events as a Measure of Safety||During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.||||participants|||Number
1406379|NCT01209260|Primary|Transseptal Access Procedure Time|Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.|Day of procedure||||minutes||Inter-Quartile Range|Median
1406380|NCT01209195|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 163 weeks, and a collection was made post-infusion in any case of infusion reaction|||||||Number
1406381|NCT01209195|Secondary|Pharmacokinetic Parameters (AUClast)|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).~Immunogenicity data is not available."|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
1406396|NCT01209078|Secondary|Mean Exudate or Pus Sub-score of SIS at Indicated Time Points|The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The exudate or pus sub-score of SIS was rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.|Up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1406382|NCT01209195|Secondary|To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week).|Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1|"All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples."|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1406383|NCT01209195|Secondary|To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 163 weeks||||participants with objective response|||Number
1406384|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.~Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|note: MTD of MM-121 when administered in combination with paclitaxel provided in separate endpoint entry|||mg/m2|||Number
1406385|NCT01209195|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort.~Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"|From date of first dose to 30 days after termination, the longest 163 weeks|NOTE: MTD of paclitaxel when administered with MM-121 provided in separate endpoint entry|||mg/kg|||Number
1406386|NCT01209195|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT)|To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 163 weeks||||participants reporting DLTs|||Number
1406387|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of Cmax of ethinyl estradiol and norethindrone were defined as the ratios of Cmax of ethinyl estradiol and norethindrone on Day 8 divided by Cmax of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL||90% Confidence Interval|Number
1406388|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Ethinyl Estradiol and Norethindrone|On Days 1 and 8, blood samples were taken prior to the administration of the contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of ethinyl estradiol and norethindrone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma ethinyl estradiol and norethindrone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratios of AUC(0-inf) of ethinyl estradiol and norethindrone were defined as the ratios of AUC(0-inf) of ethinyl estradiol and norethindrone on Day 8 divided by AUC(0-inf) of ethinyl estradiol and norethindrone on Day 1, respectively.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL*hr||90% Confidence Interval|Number
1406620|NCT01206465|Primary|Recommended Dose of PDX Given in Combination With a Fixed Dose of 5-FU Administered as a 48-hour Infusion Given Every Other Week|Maximum tolerated dose will have been exceeded when 2 patients entered at a given dose level experience specified dose-limiting toxicities in the initial cycle|During the initial course (day 1 & 15 of a 4 week schedule)||||mg per meter square|||Number
1406389|NCT01209143|Primary|Geometric Mean Ratio of the Maximum Plasma Concentration (Cmax) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of Cmax of rosiglitazone was defined as the Cmax of rosiglitazone on Day 8/ Cmax of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL||90% Confidence Interval|Number
1406390|NCT01209143|Primary|Geometric Mean Ratio of the Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-inf]) of Rosiglitazone|On Days 1 and 8, blood samples were taken prior to the administration of rosiglitazone and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose. Plasma concentrations of rosiglitazone were determined using a validated liquid chromatography mass spectrometry/mass spectrometry (LC MS/MS) assay. Individual and mean plasma rosiglitazone concentration versus time data were tabulated and plotted by analyte. The pharmacokinetic parameters of each analyte were calculated using standard non-compartmental methods (WinNonlin version 5.2.1, Pharsight Corp., Mountain View, CA). The geometric mean ratio of AUC(0-inf) of rosiglitazone was defined as the AUC(0-inf) of rosiglitazone on Day 8/AUC(0-inf) of rosiglitazone on Day 1.|Pre-dose and 30 minutes, and 1, 2, 3, 4, and 6 hours, between 8 and 12 hours, and 24 hours post-dose|Pharmacokinetic population: All participants with pharmacokinetic data on Day 1 and Day 8.|||ng/mL*hr||90% Confidence Interval|Number
1406391|NCT01209078|Secondary|Population Pharmacokinetic Parameters of Apparent Total Clearance of GSK1322322 From Plasma After Oral Administration (CL/F)|Blood samples were planned to be collected on Day 1, 0.25-1.5 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and 1.5-3 hours post-initial dose (corresponding to the safety laboratory and ECG timepoint), and Day 4, 4-12 hours post-morning dose (corresponding to the safety laboratory and ECG timepoint), and Day 8, pre-morning dose (corresponding to safety laboratory and ECG timepoint) during the outpatient visit. The data for this outcome measure was not collected and assessed.|Day 1 (0.25-1.5 hours post-initial dose, 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose) and Day 8 (pre-morning dose)|Pharmacokinetic (PK) Concentration Population defined all Participants in the “Safety Population” who underwent plasma PK sampling during the study and from whom a measurable plasma concentration above the assay’s limit of quantification were obtained for one of the treatment regimens. No participants were analyzed for this outcome measure.||||||
1406392|NCT01209078|Secondary|Percentage of Participants With Clinical Success at End of Therapy by Pathogen Isolated at Baseline|Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0. The pathogens isolated at Baseline included staphylococcus aureus (methicillin-resistant staphylococcus aureus [MRSA] and methicillin-susceptible staphylococcus aureus [MSSA] as defined by susceptibility to cefoxitin or oxacilin), streptococcus pyogenes, other streptococcus species, other Gram-positive pathogens and Gram-negative pathogens. Data is categorized for the percentage of participants with clinical success for each of the pathogens, all pathogens and no pathogens.|Up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1406393|NCT01209078|Secondary|Mean Change From Baseline in Wound Area at Indicated Time Points|The area of the infected lesion size was calculated as the product between the length (L) and width (W) of the lesion size. The wound was measured by the investigator in centimeters (cm), using a standard metric ruler. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||cm^2||Standard Deviation|Mean
1406394|NCT01209078|Secondary|Mean Change From Baseline in Total SIS at Indicated Time Points|The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Baseline was defined as the assessment value done on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline ) up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1406395|NCT01209078|Secondary|Mean Total SIS at Indicated Time Points|The investigator evaluated the infection by grading the infected lesion according to SIS. The SIS consist of 7 items of exudate or pus, crusting, erythema or inflammation, tissue warmth, tissue edema, itching and pain. The items were rated on a 7-point scale ranging from 0 to 6, where 0 indicated absence of symptom and 6 indicated severe symptom. The total score ranged from 0 to 42, where 0 indicated absence of symptoms and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up.|Up to Follow-up (28 Day Follow-up, Day 40)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1406423|NCT01209078|Primary|Mean Clinical Chemistry Parameters of Creatinine, Uric Acid, Direct Bilirubin and Total Bilirubin at Indicated Time Points|Blood samples were obtained for analysis of creatinine, uric acid, direct bilirubin and total bilirubin at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Micromoles (µmol)/liter||Standard Deviation|Mean
1406397|NCT01209078|Secondary|Mean Short Form McGill Pain Questionnaire-2 (SF-MPQ-2) Sub-score of Continuous Pain, Intermittent Pain, Neuropathic Pain and Affective Descriptors at Indicated Time Points|SF-MPQ-2 is composed of 22 items that describes different quantities of pain and related symptoms. Sub-score of continuous pain represents mean of throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain and tender (mean of items 1, 5, 6, 8, 9 and 10). Sub-score of intermittent pain represents mean of shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain and piercing (mean of items 2, 3, 4, 11, 16 and 18). Sub-score of neuropathic pain represents mean of hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles, numbness (mean of items 7, 17, 19, 20, 21 and 22). Sub-score of affective descriptors represents mean of tiring-exhaustive, sickening, fearful, punishing-cruel (mean of items 12, 13, 14 and 15). Scores ranged from 0 to 10, where 0 indicated absence of symptom and higher score indicated more severe symptoms. Assessments were done at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up.|Up to Follow-up (7 Day Follow up, Day 19)|ITTC Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1406398|NCT01209078|Secondary|Percentage of Participants With Therapeutic Success of Therapeutic Outcome|Therapeutic outcome was combined clinical and microbiological outcome. Therapeutic outcome was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic outcome. Therapeutic outcome was determined programmatically, obtained at 7 day Follow-up.|Follow-up (7 day Follow-up, Day 19)|Per Protocol Bacteriology (PPB) Population was defined as ITTB participants who adhered to protocol-specific criteria (i.e., no protocol violation ): taking 80% of medications and/or not missing more than 48 h in a row of study drug, and have both end of therapy and 7 day Follow-up to be evaluable and a documented pathogen cultured at Baseline.|||Percentage of participants||95% Confidence Interval|Number
1406399|NCT01209078|Secondary|Percentage of Participants With Microbiological Success of Microbiological Outcome at Follow-up|The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to culture results at Follow-up (Day 16-19), and corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: Baseline pathogen was eradicated or presumed eradicated at end of therapy, or Baseline pathogens were present at end of therapy and is absent at Follow-up (microbiological eradication in microbiological response); Baseline pathogen was eradicated or presumed eradicated at end of therapy, or the Baseline pathogens were present at end of therapy and, participant was a ‘clinical success’, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the eCRF (microbiological eradication); a new pathogen, not previously identified at Baseline, was identified at Follow-up in a participant who was a ‘clinical success’ (colonization)|Follow-up (7 Day Follow-up, Day 19)|ITTB Population.|||Percentage of participants|||Number
1406400|NCT01209078|Secondary|Percentage of Participants With Microbiological Success of Microbiological Outcome at End of Therapy|The 'by pathogen' microbiological response was determined by comparing the Baseline (Day 1) culture results to the culture results at the end of therapy (visit window of Day 12-14), and the corresponding microbiological outcome (success or failure) by participant was then assigned. Microbiological success was defined as: elimination of Baseline pathogens (defined as microbiological eradication in microbiological response); clinical outcome was success such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and was documented in the electronic case report form (eCRF) (defined as presumed microbiological eradication in microbiological response); new pathogen not previously identified, was identified at end of therapy in a participant who was a ‘clinical success’ (defined as colonization in microbiological response).|Day 11 (end of therapy)|Intent-to-Treat Bacteriology (ITTB) Population was defined as all randomized participants who received at least one dose of study medication and who had a pathogen isolated at Baseline.|||Percentage of participants|||Number
1406401|NCT01209078|Secondary|Percentage of Participants With Clinical Success of Clinical Outcome|The clinical response was determined by the investigator after clinical evaluation of reviewing clinical signs and symptoms at end of therapy (within 3 days post therapy; visit window of Day 12-14) and 7 day Follow-up ( visit window of Day 16 to 19), and the resulting clinical outcome was assigned, for each participant. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudates SIS of 0.|Day 11 (end of therapy) and Follow-up (7 Day Follow-up, Day 19)|ITTC Population.|||Percentage of participants|||Number
1406402|NCT01209078|Secondary|Number of Participants With Clinical Success of Clinical Response|The clinical response was evaluated by the investigator at end of therapy (within 3 days post therapy; Day 12-14) and Follow-up (7 day Follow-up; Day 16 to 19 and 28 day Follow-up; Day 37 to 40). Clinical response was determined after clinical evaluation of reviewing clinical signs and symptoms. Clinical success was defined as total resolution of all signs and symptoms of infection recorded at Baseline, or improvement to such an extent that no further antimicrobial therapy was necessary, including a pus/exudate skin infection score (SIS) of 0.|Up to Follow-up (28 Day Follow-up, Day 40)|Intent-to-Treat Clinical (ITTC) Population was defined as all randomized participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1406403|NCT01209078|Primary|Number of Participants With Abnormal Transition From Baseline in Hematology Values Relative to Normal Range|The parameters of clinical chemistry included basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC count, platelet count, MCV, hemoglobin, MCHC, MCH, RBC count and reticulocyte count. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline ‘to high’ or ‘to low’ relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.|Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1406404|NCT01209078|Primary|Number of Participants With Abnormal Transition From Baseline in Clinical Chemistry Values Relative to Normal Range|The parameters of clinical chemistry included albumin, total protein, ALT, ALP, AST, GGT, LDH and creatine kinase, creatinine, uric acid, direct bilirubin, total bilirubin, glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN and high sensitivity C-Reactive protein. The assessments were done at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline was defined as the assessment done on Day 1 (pre-dose). Data is reported for number of participants with abnormal transition from Baseline ‘to high’ or ‘to low’ relative to normal range. Only those parameters for which at least one value of abnormal transition was reported are summarized.|Day 1 (pre-dose, Baseline) up Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1406405|NCT01209078|Primary|Mean Change From Baseline in ECG Rhythms at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The value recorded pre-dose on Day 1 was the Baseline. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.|Day 1 (pre-dose, Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1406406|NCT01209078|Primary|Mean ECG Rhythms at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rhythm and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart and the mean of the three measurements was calculated. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour).|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1406407|NCT01209078|Primary|Mean Change From Baseline in ECG Values at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett’s formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). Mean value recorded pre-dose on Day 1 was classified as Baseline. Change from Baseline was calculated by subtracting the Baseline value from individual post-Baseline (Day 1 post-dose, Day 4, Day 8 and Day 11) values.|Day 1 (pre-dose, Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
1406408|NCT01209078|Primary|Mean Electrocardiogram (ECG) Values at Indicated Time Points|12-lead ECGs were obtained during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, RR, QT, and QTc intervals. It was performed with the participant in a semi-supine position having rested in that position for at least 10 minutes beforehand. Three measurements were taken at pre-dose on Day 1 at least 5 minutes apart. The mean PR interval, RR interval, QRS duration, uncorrected QT interval (UncQT) and QTcB (QT corrected by Bazett’s formula) and QTcF (corrected by Friedericia's formula) was calculated from automated ECG readings. The assessments were done at Day 1 (pre-dose, 0.25-1.5 hours post-initial dose and 1.5-3 hours post-initial dose), Day 4 (4-12 hours post-morning dose), Day 8 (pre-morning dose) and Day 11 (0 hour). The mean value recorded pre-dose on Day 1 was classified as Baseline.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
1406409|NCT01209078|Primary|Mean Change From Baseline in RR at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
1406410|NCT01209078|Primary|Mean Change From Baseline in HR at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1406514|NCT01207687|Secondary|Percent Change in Median Vascular Permeability (Ktrans)|Correlation assessment were planned for imaging parameters and hearing response based on the estimated changes in Ktrans: a MRI measure of vascular permeability. Only 1/14 participants had complete Ktrans data that was amenable to analysis at baseline and week 72. Hence, these statistical analyses were not possible.|Baseline to week 72||||percent change in median Ktrans|||Number
1406411|NCT01209078|Primary|Mean Change From Baseline in SBP and DBP at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study. The change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 2, Day 3, Day 4, Day 8 and Day 11) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to missing as well.|Day 1 (Baseline) up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1406412|NCT01209078|Primary|Mean Vital Sign Value of Respiratory Rate (RR) at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three RR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single RR was obtained at all other time points during the study.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
1406413|NCT01209078|Primary|Mean Vital Sign Value of Heart Rate (HR) at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three HR measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single HR was obtained at all other time points during the study.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1406414|NCT01209078|Primary|Mean Vital Sign Value of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|Vital sign assessments were conducted at Day 1 (pre-dose), Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (4-12 hours post-dose), Day 8 (pre-dose) and Day 11. The assessments were made with the participant in a semi-supine position, having rested in that position for at least 10 minutes beforehand. Three BP measurements were taken at pre-dose on Day 1. The mean value recorded at pre-dose was classified as Baseline. Single BP was obtained at all other time points during the study.|Up to Day 11|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1406415|NCT01209078|Primary|Mean Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count at Indicated Time Points|Blood samples were obtained for analysis of RBC count and reticulocyte at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Trillion cells (TI)/Liter||Standard Deviation|Mean
1406416|NCT01209078|Primary|Mean Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points|Blood samples were obtained for analysis of MCH at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Picogram||Standard Deviation|Mean
1406417|NCT01209078|Primary|Mean Hematology Parameter of Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points|Blood samples were obtained for analysis of MCHC at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram/Liter||Standard Deviation|Mean
1406418|NCT01209078|Primary|Mean Hematology Parameter of Mean Corpuscle Volume (MCV) at Indicated Time Points|Blood samples were obtained for analysis of MCV at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
1406419|NCT01209078|Primary|Mean Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC) and Platelet Count at Indicated Time Points|Blood samples were obtained for analysis of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC and platelet count at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Giga cells/Liter||Standard Deviation|Mean
1406420|NCT01209078|Primary|Mean Clinical Chemistry Parameter of High Sensitivity C-Reactive Protein at Indicated Time Points|Blood samples were obtained for analysis of high sensitivity C-Reactive protein at Day 1, Day 2, Day 3, Day 4, Day 8, Day 11 and 7 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (7 Day Follow-up, Day 19)|Safety Population. Only those participants available at the specified time points were analyzed.|||mg/Liter||Standard Deviation|Mean
1406421|NCT01209078|Primary|Mean Clinical Chemistry Parameter of Estradiol at Indicated Time Point|Blood samples were obtained for analysis of estradiol at Day 1.|Day 1|Safety Population. Only those participants available at the specified time points were analyzed.|||Picomole (pmol)/Liter||Standard Deviation|Mean
1406422|NCT01209078|Primary|Mean Clinical Chemistry Parameters of Glucose, Sodium, Calcium, Potassium, Chloride, Carbon Dioxide (CO2) Content /Bicarbonate and Urea/ Blood Urea Nitrogen (BUN) at Indicated Time Points|Blood samples were obtained for analysis of glucose, sodium, calcium, potassium, chloride, CO2 content /bicarbonate and urea/BUN at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole (mmol)/Liter||Standard Deviation|Mean
1406424|NCT01209078|Primary|Mean Clinical Chemistry Parameters of ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH), Gamma Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase at Indicated Time Points|Blood samples were obtained for analysis of ALT, ALP, AST, FSH, GGT, LDH and creatine kinase at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||International units (IU)/Liter||Standard Deviation|Mean
1406425|NCT01209078|Primary|Mean Clinical Chemistry Parameters of Albumin and Total Protein at Indicated Time Points|Blood samples were obtained for analysis of albumin and total protein at Day 1, Day 4, Day 8, Day 11, 7 Day Follow-up and 28 Day Follow-up. Baseline value was defined as the assessment done on Day 1.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram/Liter||Standard Deviation|Mean
1406426|NCT01209078|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5.|Up to Follow-up (28 Day Follow-up, Day 40)|Safety Population was defined as all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1406427|NCT01208961|Primary|C(Max): Maximum Plasma Concentration|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.||||nmol/mL||Full Range|Geometric Mean
1406428|NCT01208961|Primary|AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.||||nmol.h/mL||Full Range|Geometric Mean
1406429|NCT01208961|Primary|AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)|Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.|Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.||||nmol.h/mL||Full Range|Geometric Mean
1406430|NCT01208870|Secondary|Changes in Variety Measures|Variety of high energy density foods (RED) and low energy density foods (GREEN) were calculated from the Food Frequency Questionnaire (FFQ) for pilot 1 and 24 hour recalls (24-HR) for pilot 2. High energy dense food or Red foods are low in nutrient density. Most Red foods come from the Fats, Oils and Sweets groups and are to be used sparingly. Modified foods from the Fats, Oils, and Sweets group are still considered to be Red foods, even if their energy level is low. These foods contribute little nutrients to the diet and compete for consumption of healthier foods. Green foods are high in nutrient density and low in energy density. Most Green foods come from the fruit and vegetable groups. Serving sizes were based off the serving sizes used in United States Department of Agriculture (USDA) common serving sizes. Coding was based on the serving sizes of the specified food items and used to calculate the changes from baseline to six months.|Baseline to 6 months|Parents and children were measured, three families did not complete the dietary measures.|||food items||Standard Deviation|Mean
1406431|NCT01208870|Secondary|Change in Child Delay Discounting|Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure impulsivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant’s discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in higher K-values (0.25 vs 0.00016).|Baseline to 6 months|Children that completed this measure at pre and post time points. Eleven children did not complete the post measure.|||k value||Standard Deviation|Mean
1406432|NCT01208870|Secondary|Change in Parent Delay Discounting|Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure implusivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant’s discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in K-values. (0.25 impulsive to 0.00016 not impulsive)|Baseline to 6 months|Parents that completed this measure pre and post. Ten parents did not complete this post measure.|||k value||Standard Deviation|Mean
1406433|NCT01208870|Primary|Change Parent Body Composition|Parent Body Mass Index (kg/m^2) difference from baseline to 6 months|Baseline to 6 months|Parents|||kg/m^2||Standard Deviation|Mean
1406434|NCT01208870|Secondary|Change in Dietary Intake of Calories|Energy intake was calculated for parents and children as the different from baseline to six months of calories consumed. The first pilot used the calories generated from the Food Frequency Questionnaire (FFQ) report however the second pilot used calories from 24 hour recalls based on the Center of Disease Control data base or food labels.|Baseline to 6 months|Parents and children, three families did not complete the dietary measures.|||calories||Standard Deviation|Mean
1406435|NCT01208870|Primary|Change of Child Body Composition|Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.|Baseline to 6 months|Children that completed the reported measures. Two children did not complete the body composition measures from the experimental groups and four children from the control group did not complete this measure.|||percentage of weight||Standard Error|Mean
1406436|NCT01208415|Primary|Patients That Are Free From Patency-related Intervention|Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms.|6 Months|Of the 37 patients available for analysis at 6 months, data was available for 34 patients.|||participants|||Number
1406437|NCT01208402|Secondary|Percentage of Postoperative Hours 4 to 12 With Systolic Blood Pressure <95 mmHg|Duration of postoperative hours 4 to 12 patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 9 hours. SBP was measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting BB group and in 16 cases in the Esmolol group.|||percentage of 8 hour interval||Inter-Quartile Range|Median
1406438|NCT01208402|Primary|Percentage of Postoperative Hours 4 to 12 With Heart Rate (HR) <60 or >80 Bpm.|Duration of postoperative hours 4 to 12 spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 9 hours. Vital signs are measured during hours four and five at 30 minute intervals and once every hour for the next 7 hours, through 12 hours postoperatively.|Postoperative hours 4-12|Specific vital sign measurements were available for calculation of outcomes during the final 9 hours postoperatively in 18 cases in the Long-Acting beta blocker group and in 16 cases in the Esmolol group.|||percentage of 8 hour interval||Inter-Quartile Range|Median
1406439|NCT01208402|Secondary|Percentage of Postoperative First Three Hours With Systolic Blood Pressure <95 mmHg|Duration of postoperative first three hours patient was not in the target window of SBP > 95 mmHg, expressed as percent of the total 3 hours. SBP is measured from end of surgery to 3 hours postoperatively at 5 minute intervals for first hour and every 15 minutes thereafter.|end of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.|||percentage of 3 hour interval||Inter-Quartile Range|Median
1406440|NCT01208402|Primary|Percentage of Postoperative First Three Hours With Heart Rate (HR) <60 or >80 Bpm|Duration of postoperative first three hours spent outside Target HR range defined as 60 to 80 bpm, expressed as percent of the total 3 hours. Vital signs are measured from end of surgery to 3 hours postoperatively at 5 minute intervals for the first hour and every 15 minutes thereafter.|End of surgery to 3 hours|Ten cases (7 in the oral long acting beta blocker group and 3 in the Esmolol infusion group) were missing some of the postoperative vital sign measurements, resulting in gaps too long for valid calculation of the postoperative outcomes only.|||percentage of 3 hour interval||Inter-Quartile Range|Median
1406441|NCT01208402|Secondary|Percentage of Intraoperative Case Time With Systolic Blood Pressure <95 mmHg|Duration of intraoperative case time patient was not in the target window of SBP > 95 mmHg, expressed as percent of total case minutes. SBP is measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.|||percentage of surgery minutes||Inter-Quartile Range|Median
1406442|NCT01208402|Primary|Percentage of Intraoperative Case Time With Heart Rate (HR) <60 or >80 Bpm|Duration of intraoperative excursion (ie, time spent) outside Target HR range defined as 60 to 80 bpm during surgery, expressed as percent of case minutes. Vital signs are measured from start of surgery to end of surgery at 5 minute intervals or less.|Start of surgery to end of surgery, an average duration of 245 minutes|Three enrolled cases (1 in the oral long acting beta blocker group and 2 in the Esmolol infusion group) were excluded from calculations a priori because they received diltiazem, a calcium channel blocker which lowers heart rate, before the operation.|||percentage of case minutes||Inter-Quartile Range|Median
1406443|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|5 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.|||participants|||Number
1406444|NCT01208337|Secondary|Incidence of Patients in Whom Tacrolimus Whole Blood Concentration Less Than 10 ng/ml Are Being Used at 1-year Follow-up.|Tacrolimus whole blood concentrations less than 10 ng/ml|1 year|It is believed that patients whom received Alemtuzumab at the time of transplant and continue post-transplant with functioning grafts will have Tacrolimus whole blood concentrations less than 10ng/ml.|||participants|||Number
1406445|NCT01208337|Secondary|Incidence of Patients in Whom Steroids Are Not Used|As part of analysis for assessing effectiveness and safety of Alemtuzumab Induction at the time of transplant, it is important to assess the incidence in which patients enrolled were able to wean off of steroids post-transplant compared to historical controls.|1 year|Induction of Alemtuzumab at time of transplant may increase the likelihood of weaning off steroids sooner after transplant than patients who did not receive Alemtuzumab as induction immunosuppression medication.|||participants|||Number
1406446|NCT01208337|Secondary|Incidence of Biopsy-proven Acute Cellular Rejection|Biopsy-proven incidence of acute cellular rejection|1 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).|||participants|||Number
1406447|NCT01208337|Primary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)|Asses safety of Alemtuzumab in combination with Tacrolimus and steroids in twenty-three pediatric intestine allograft recipients by calculating the rate in which PTLD occurred amongst the study population.|5 Year|Alemtuzumab induction at the time of transplant may reduce the rate of early acute cellular rejection compared with historical controls, but may increase rate of alternate post-transplant complications, such as Post Transplant Lymphoproliferative Disorder (PTLD).|||participants|||Number
1406448|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.|||blocks moved per minute||Standard Error|Least Squares Mean
1406449|NCT01208233|Other Pre-specified|Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
1406450|NCT01208233|Other Pre-specified|Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2)||Day 1 (Baseline) up to Day 14|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
1406451|NCT01208233|Other Pre-specified|Number of Participants With Neuro-worsening (Part 2)|NIHSS change of 4 points or greater.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
1406452|NCT01208233|Other Pre-specified|Mortality Directly Related to Stroke (Part 2)|Deaths caused by stroke were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
1406453|NCT01208233|Other Pre-specified|All-cause Mortality (Part 2)|Deaths regardless causality were reported.|The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.|The FAS consisted of all randomized participants who took any study medication (active or placebo).|||Number of participants|||Number
1406454|NCT01208233|Secondary|Plasma Concentrations of PF-03049423 (Part 1 and 2)||Days 1, 2, 7, 14, 30, 60 and 90|PK concentration population included all participants who were treated with PF-03049423 who had at least 1 measurable concentration. n=participants with concentration above lower limit of quantification at the corresponding sampling time.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1406455|NCT01208233|Secondary|Gait Velocity Test at Day 90 (Part 2)|The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk “at a comfortable pace” at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant’s limb crossed the first marker and stopping the stopwatch as soon as the participant’s limb crossed the second marker.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||meters/second (m/s)||Standard Error|Least Squares Mean
1406456|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)|This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||pictures correctly identified||Standard Error|Least Squares Mean
1406465|NCT01208233|Secondary|Percentage of Participants With mRS (0-1) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).|||percentage of participants|||Number
1406621|NCT01206452|Secondary|Inflammatory Cytokine Response to Ablation Procedure|Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration.|24 Hours after Ablation Procedure||||pg/ml||Standard Deviation|Mean
1406457|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated participants included for comparison between active drug and placebo for this outcome measure.|||change in ratio||Standard Error|Least Squares Mean
1406458|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Line Cancellation Test [(L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%)] at Day 90 (Part 2)|The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo for this outcome measure.|||change in percentage of lines crossed||Standard Error|Least Squares Mean
1406459|NCT01208233|Secondary|Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)|This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||objects named correctly||Standard Error|Least Squares Mean
1406460|NCT01208233|Secondary|Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)|The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||correct responses||Standard Error|Least Squares Mean
1406461|NCT01208233|Secondary|BI at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant’s ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||unit on a scale||Standard Error|Least Squares Mean
1406462|NCT01208233|Secondary|Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)|The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant’s ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).|||percentage of participants|||Number
1406463|NCT01208233|Secondary|Change From Baseline in NIHSS at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.|||unit on a scale||Standard Error|Least Squares Mean
1406464|NCT01208233|Secondary|Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)|The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.|Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).|||percentage of participants|||Number
1406466|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated those participants included for comparison between active drug and placebo.|||percentage change||Standard Error|Least Squares Mean
1406467|NCT01208233|Secondary|Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)|The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.|||pounds||Standard Error|Least Squares Mean
1406468|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.|||percentage change||Standard Error|Least Squares Mean
1406469|NCT01208233|Secondary|Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)|The B&B test is a measure of manual dexterity. The B&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.|Day 1 (Baseline), Day 90|The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.|||blocks moved per minute||Standard Error|Least Squares Mean
1406470|NCT01208233|Primary|Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)|The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).|Day 90|The Inferential Full Analysis Set (I-FAS) consisted of participants within the FAS who were randomized to PF-03049423 maximum tolerated dose (MTD) or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.|||percentage of participants|||Number
1406471|NCT01208233|Primary|Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)|"Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Code 3) (“Yes” on “aborted attempt”, interrupted attempt”, preparatory acts or behavior”), suicidal ideation (Code 4) (“Yes” on “wish to be dead”, non-specific active suicidal thoughts”, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for any of above mentioned categories was assessed. *This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together."|Day 7 (Baseline) up to follow up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of participants who had C-SSRS assessed at that visit.|||participants|||Number
1406513|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|Baseline||||units on a scale||Full Range|Median
1406472|NCT01208233|Primary|Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)|The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had neurological examinations done at both baseline and last visit.|||participants|||Number
1406473|NCT01208233|Primary|Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)|The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had physical examinations done at both baseline and last visit.|||participants|||Number
1406474|NCT01208233|Primary|Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QT interval: >=500 msec, QTc interval using Fridericia’s formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; absolute change 30 - <60, >=60 msec. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.|||participants|||Number
1406475|NCT01208233|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from grand baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine, sitting and standing): <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to follow-up (28 days after Day 90)|The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.|||participants|||Number
1406476|NCT01208233|Primary|Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. *This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.|Day 1 (Baseline) up to Day 90|The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated number of participants evaluated.|||participants|||Number
1406477|NCT01208220|Primary|Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)||2 weeks into study||||Percentage of red granulation tissue|||Number
1406478|NCT01208220|Secondary|Removal of Harmful Fluids in the Wound Tissue||2 weeks into study||||percentage of cytotoxins removed|||Number
1406479|NCT01208207|Primary|Number of Participants Discontinuing Study Treatment Due to an Adverse Event||Up to 26 weeks|All Patients as Treated Population (APaT) - Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.|||Participants|||Number
1406480|NCT01208207|Secondary|Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.|Week 6 to Week 10 and Week 12|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.|||mm VAS||95% Confidence Interval|Least Squares Mean
1406481|NCT01208207|Secondary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data.|||mm VAS||95% Confidence Interval|Least Squares Mean
1406622|NCT01206452|Secondary|Inflammatory Cytokine Response to Ablation Procedure|Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery.|Immediately Post-Ablation Procedure||||pg/ml||Standard Deviation|Mean
1406482|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.|||mm VAS||95% Confidence Interval|Least Squares Mean
1406483|NCT01208207|Primary|Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen|Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline and up to Week 6|Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.|||mm VAS||95% Confidence Interval|Least Squares Mean
1406484|NCT01208181|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 12|ASaT population defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of participants|||Number
1406485|NCT01208181|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 112 days|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of participants|||Number
1406486|NCT01208181|Secondary|Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with <50% improvement from baseline in PGAP [VAS] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed."|Week 6 and Week 10 to Week 12|This population (a subpopulation of the mITT population) was composed of pain inadequate responder (PIRs) in Part 1. PIRs were defined as participants with <50% improvement from baseline in Patient Global Assessment of Pain (VAS) at Week 6 and received at least one dose of study medication in Part 2.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1406487|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1406488|NCT01208181|Secondary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1406489|NCT01208181|Primary|Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)|"A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed."|Baseline and Week 6|The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1406490|NCT01208181|Primary|Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)|Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.|Baseline and Week 6|The modified intention-to-treat (mITT) population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1406491|NCT01207934|Secondary|Post-treatment Plasma Leptin Levels|plasma leptin levels after fourteen days ingestion of either leptin or placebo.|fourteen days||||Micrograms/Liter||Standard Error|Mean
1406492|NCT01207934|Primary|Post-treatment Glucose Disposal. I.e. Glucose Disposal After Treatment With Leptin or Placebo.|This is a measure of the body's ability to metabolize sugar after treatment with either leptin or a placebo. We compare the effect of leptin therapy on insulin-mediated stimulation of glucose disposal with that of placebo. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|fourteen days||||mmol/kg body weight/minute||Standard Error|Mean
1406493|NCT01207934|Secondary|Baseline Plasma Leptin Concentrations|Leptin is an endogenous hormone. Here we measure the pre-treatment concentration of naturally-occurring leptin in the blood.|baseline||||Micrograms/Liter||Standard Error|Mean
1406494|NCT01207934|Primary|Baseline Glucose Disposal - a Measure of the Body's Ability to Process Sugars.|pre-treatment glucose disposal. In general, a high glucose disposal rate is a marker of healthy metabolic function. Glucose disposal is measured by tracking the amount of tagged glucose in the bloodstream over time. It is adjusted to subject body weight.|baseline||||mmol/kg body weight/minute||Standard Error|Mean
1406495|NCT01207765|Secondary|Degree of CD20 Expression on Plasma Cells and/or Targeting of Post-germinal Center B Cells Correlation With Toxicity, Response and Biodistribution|CD20 immunohistochemical staining of plasma cells on baseline bone marrow biopsy specimen, graded on qualitative scale (0 to +++)|2 weeks prior - 2 weeks post transplant|Immunohistochemical analysis showed inconsistent / insufficient CD20 staining on surface of plasma cells; comparisons could not be made||||||
1406496|NCT01207765|Secondary|Time to Engraftment in Patients Who Proceed to Myeloablative Chemotherapy After Receiving 90Y Zevalin® (Ibritumomab Tiuxetan).|Number of days from stem cell infusion (day +0) to day of neutrophil engraftment (first of three consecutive days with absolute neutrophil count > 500)|Transplant through day 42|Analyzed on intent-to-treat basis|||Days||Full Range|Median
1406497|NCT01207765|Primary|Safety and Efficacy|Efficacy: objective response rate (CR + PR) at 12 and 104 days following radioimmunotherapy. Safety: the rate of occurrence of defined toxic events including non-engraftment and unacceptable biodistribution of 90Y Zevalin occurring by day +42 following transplant. Response determined according to Blade' Criteria (Bladé J, Br J Haematol.1998 Sep;102(5):1115-23) for multiple myeloma; Response based on reduction of monoclonal protein (M-protein) from initial presentation.|Through day +104 following immunotherapy|6 subjects had objectively measurable disease and were evaluable for response, 8 subjects received study intervention and are evaluable for safety|||participants|||Number
1406498|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 – 104 with higher scores indicating more distress related to tinnitus.|18 months|At this time point, one participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406499|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 – 104 with higher scores indicating more distress related to tinnitus.|12 months|At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406500|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 – 104 with higher scores indicating more distress related to tinnitus.|6 months|At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. One participant did not complete this questionnaire at this time point. Hence, data from 12 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406501|NCT01207687|Secondary|Quality of Life Assessed by the Tinnitus Reaction Questionnaire (TRQ)|The TRQ is a 26 item patient reported outcome. It is scored using a 5 point Likert scale (0-4). The responses are summed, resulting in a range of 0 – 104 with higher scores indicating more distress related to tinnitus.|baseline||||units on a scale||Full Range|Median
1406502|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|18 months|One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406503|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|12 months|At this time point, one participant was off study due to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406504|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Responses are recorded on a scale from 0 - 10, with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score for each subscale is reported. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|6 months|At this time point, one participant was off study due to adverse events and did not complete the questionnaire. Three participants did not complete the questionnaire at this time point. Hence, data from 10 participants were available for analysis.|||units on a scale||Full Range|Median
1406505|NCT01207687|Secondary|Quality of Life as Assessed by the Speech and Spatial Qualities Questionnaire (SSQ)|"The SSQ is a 49 item patient-reported outcome with three subscales: speech understanding (14 questions), spatial location of sounds (17 questions), and the qualities of sounds (18 questions) as they appear to the patient with hearing impairment. Each response is recorded on an 11 point scale (0 - 10), with the anchor points not at all (= 0) and perfectly (=10). A higher score indicates better hearing. The median score is reported for each subscale. The minimum and maximum scores for the median of each subscale would be 0 and 10, respectively."|baseline||||units on a scale||Full Range|Median
1406506|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|18 months|One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||T-score||Full Range|Median
1406507|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|18 months|One participant had withdrawn consent from the study and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406508|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|12 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||T-score||Full Range|Median
1406509|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|12 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406510|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|6 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||T-score||Full Range|Median
1406511|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 1 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items.|6 months|One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point.|||units on a scale||Full Range|Median
1406512|NCT01207687|Secondary|Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores|The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population.|Baseline||||T-score||Full Range|Median
1406515|NCT01207687|Secondary|Number of Participants With Changes in Function of the Auditory System|The primary distortion product optoacoustic emissions (DPOAE) measurement will be treated non-parametrically (present or absent across time) DPOAE’s will be considered present at the frequency of F2 when the distortion product is 6dB above the noise floor. Variables will be analyzed for differences using t-tests if the effects and sample sizes warrant, but this may not be advisable given the small numbers to be accrued.|Baseline to 6 months post-treatment|Distortion product optoacoustic emissions (DPOEs) were only obtained for participants at the NCI site; thus, data from 5 participants were analyzed.|||Participants|||Count of Participants
1406516|NCT01207687|Secondary|Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI|The median percent change in the volume of the target vestibular schwannoma using volumetric MRI|Baseline to 12 months||||percentage of change in tumor volume||Full Range|Median
1406517|NCT01207687|Secondary|Radiographic Response|The proportion of participants with radiographic response as measured by a >/= 20% reduction in tumor volume from baseline on MRI imaging will be estimated using a binomial distribution.|Baseline to 6 months post-treatment||||participants||95% Confidence Interval|Number
1406518|NCT01207687|Secondary|Incidence of Serious or Life Threatening Toxicities|The number of patients with serious or life threatening toxicities (CTCAE grade 3 or above)|Up to 6 months post-treatment|Participants evaluated for serious or life threatening toxicities|||Participants|||Count of Participants
1406519|NCT01207687|Primary|Proportion of Patients With Hearing Response|A hearing response was defined as increased word recognition score above the 95% critical threshold that is maintained across two sequential evaluation time points. The word recognition score (WRS) is the percentage of phonetically-balanced, monosyllabic words that a patient can accurately repeat presented at either most comfortable level or most intelligible level.The proportion of patients with hearing response in the target ear was estimated using a binomial distribution along with 95% confidence intervals.|Baseline to 12 months|All people who underwent treatment were analyzed. Two patients stopped treatment early. One due to toxicity at week 25 and one due to need for medical care not permitted while on treatment at week 49.|||Proportion with hearing response||95% Confidence Interval|Number
1406520|NCT01207648|Secondary|Time to First Medically Confirmed Clinical Relapse Post-Rebif® Initiation|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Months||95% Confidence Interval|Median
1406521|NCT01207648|Secondary|Annualized Medically Confirmed Clinical Relapses Rate Prior to Rebif® Initiation and During Rebif® Treatment|Medically confirmed clinical relapses were defined as the emergence of new neurological symptoms that occurred more than 30 days after a previous attack and persisted for more than or equal to 24 hours in the absence of known inter-current illness. Annualized relapse rate was defined as number of attacks per year.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Multiple sclerosis (MS) analysis set is a subset of the “Retrospective Cohort” set included all participants with a final diagnosis of MS. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Attacks per year|||Number
1406522|NCT01207648|Primary|Number of Participants With Abnormal Laboratory Parameters|Laboratory parameters assessed for abnormality were: total white blood cell count (Neutrophils, Lymphocytes, Leukocytes, Monocytes, Eosinophils and Basophils), differential hematogram (Hematocrit, Erythrocytes, Hemoglobin, and Platelet), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and thyroid tests (including Triiodothyronine, Thyroxine, Thyroperoxidase Antibody and Thyroid-Stimulating Hormone). Due to the retrospective nature of the study, laboratory data should be interpreted with caution as data were not collected according to a specific time schedule and the time on study per participant was not standardized.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study. 'n' signifies number of participants who were evaluable for the specified categories.|||Participants|||Number
1406523|NCT01207648|Primary|Number of Participants With Serious Medical Events, and Non-serious Medical Events (Reported by the Investigator as Related to Rebif®)|Medical events in the retrospective study are equivalent to adverse events in a prospective clinical study. A medical event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious medical event: A medical event that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants may be represented in more than one category as participant who had experienced serious medical event may also had experienced non-serious medical event reported by the Investigator as related to Rebif®, so in that case it will be counted in both the categories.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.|||Participants|||Number
1406548|NCT01207492|Secondary|Clinical Benefit Rate|To determine the clinical benefit rate [% CR + % PR + % stable disease by RECIST 1.1] at 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|6 months||||percentage of participants||95% Confidence Interval|Number
1406524|NCT01207648|Primary|Number of Participants With Pre-specified Medical Events|These pre-specified medical events categories were evaluated: injections site reactions, flu-like symptoms, hepatic disorders, blood cell disorders, allergic reactions, epilepsy and convulsive disorders, thyroid dysfunction, autoimmune diseases, bone/epiphyseal and cartilage disorders, serious infections, malignancies. Each category defined by group of events which best fit the medical concept either using a standard medical dictionary for regulatory activities (MedDRA) Query (SMQ) e.g., Malignancies was defined by the SMQ Malignancies (narrow scope) containing more than 1800 different preferred terms (PTs) (including procedures and lab tests) or using a customized query, e.g., Serious infections was defined by all PTs assessed as serious in System Organ Class (SOC) Infections and Infestation. Participants may be represented in more than once in a category (Participants could have reported several medicals events pertaining to a specific category) as well as in more than one category.|Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.|Total analysis set included all the participants who were exposed to Rebif® for treatment of demyelinating event and were evaluated in this retrospective study.|||Participants|||Number
1406525|NCT01207596|Secondary|Global Assessment of Treatment Satisfaction|Patients were asked to rate their global assessment of treatment satisfaction, ranging from “very dissatisfied” to “very satisfied”. Adverse events were monitored throughout the study|Baseline visit to Week 12 or last visit|LOCF|||percentage of patients|||Number
1406526|NCT01207596|Secondary|Pain Quality Assessment Scale (PQAS)|The PQAS is a 20-item scale that quantifies the quality and intensity of neuropathic and non-neuropathic pain; scores range from 1 to 200, with higher scores indicating more severe pain|Baseline visit to 12 weeks visit|LOCF|||units on a scale||Standard Error|Mean
1406527|NCT01207596|Secondary|Sleep Quality Assessment (SQA)|Sleep Quality Assessment (SQA) scale, asking patients to assess the degree that pain has interfered with their sleep in the last 24 hours (where 0 = does not interfere and 10 = completely interferes)|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Deviation|Mean
1406528|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now|"Change from baseline to end of study on question #4 (current pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that tells how much pain you have right now, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Error|Mean
1406529|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours|"Change from baseline to end of study on question #4 (least pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Deviation|Mean
1406530|NCT01207596|Secondary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours|"Change from baseline to end of study on question #3 (worst pain) of the Brief Pain Inventory (BPI): Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Deviation|Mean
1406531|NCT01207596|Primary|Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale|The primary efficacy measure was the change from baseline to end of study on question #5 (“average pain”) of the Brief Pain Inventory (BPI): “Please rate your pain by marking the box beside the number that best describes your pain on the average,” where 0 = no pain and 10 = pain as bad as you can imagine.|Baseline visit to Week 12 or last visit|LOCF|||units on a scale||Standard Error|Mean
1406532|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 4|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.|||Percentage of participants|||Number
1406533|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 3|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.|||Percentage of participants|||Number
1406534|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 2|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.|||Percentage of participants|||Number
1406535|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Systemic Events Post-dose 1|Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.|||Percentage of participants|||Number
1406549|NCT01207492|Secondary|Overall Tumor Response Rate (OR)|To determine overall tumor response rate [% complete response (CR) + % partial response (PR) by RECIST 1.1]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR) is a disappearance of all target lesions. Partial Response (PR) is a >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.|2 years||||percentage of participants||95% Confidence Interval|Number
1406536|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 4|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.|||Percentage of participants|||Number
1406537|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 3|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.|||Percentage of participants|||Number
1406538|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.|||Percentage of participants|||Number
1406539|NCT01207583|Secondary|Percentage of Participants With Pre-Specified Local Reactions Post-dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.|||Percentage of participants|||Number
1406540|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 4|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.|Day 1 to Day 3 post-dose 4|Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4.|||Percentage of participants||95% Confidence Interval|Number
1406541|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 3|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 3|Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3.|||Percentage of participants||95% Confidence Interval|Number
1406542|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 2|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.|Day 1 to Day 3 post-dose 2|Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2.|||Percentage of participants||95% Confidence Interval|Number
1406543|NCT01207583|Primary|Percentage of Participants With Febrile Reactions Post-dose 1|Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.|Day 1 to Day 3 post-dose 1|Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1.|||Percentage of participants||95% Confidence Interval|Number
1406544|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion on day 4 after the crossover treatment|Day 4 after treatment||||degree||Standard Deviation|Mean
1406545|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle dorsiflexion passive range of motion|Day 1 after treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.|||degree||Standard Deviation|Mean
1406546|NCT01207570|Primary|Ankle Passive Range of Motion|Ankle passive range of motion at day 4 before the crossover treatment|day 4 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.|||degree||Standard Deviation|Mean
1406547|NCT01207570|Primary|Ankle Passive Range of Motion|The ankle passive range of motion will be measured by a Myrin goniometer.|day 1 before treatment|All subjects received the intended treatment protocol and were included in the analysis. ITT was used to analyze the data.|||degree||Standard Deviation|Mean
1406550|NCT01207492|Primary|Percentage of Participants With Progression Free Survival|To estimate progression free survival at 6 months in participants with recurrent PVNS treated with nilotinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months||||percentage of participants with PFS||95% Confidence Interval|Number
1406551|NCT01207466|Primary|Quality of Vision (Crisp and Clear)|Quality of vision (crisp and clear), as interpreted and reported by the participant by eye on a questionnaire as a single, retrospective evaluation of one week’s wear time. Quality of vision was assessed on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale|Participants|Standard Deviation|Mean
1406552|NCT01207453|Secondary|Knee Pain Threshold|A measure of the change in knee pain threshold from baseline to 6 weeks. Knee pain threshold was determined by applying pressure to a subject's knee until the subject felt pain. The difference between the average knee pain threshold (an average for the right and left knees) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
1406553|NCT01207453|Secondary|Wrist Pain Threshold|A measure of the change in wrist pain threshold from baseline to 6 weeks. Wrist pain threshold was determined by applying pressure to a subject's wrist until the subject felt pain. The difference between the average wrist pain threshold (an average for the right and left wrists) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
1406554|NCT01207453|Secondary|Trapezius Pain Threshold|A measure of the change in trapezius pain threshold from baseline to 6 weeks. Trapezius pain threshold was determined by applying pressure to a subject's trapezius muscle until the subject felt pain. The difference between the average trapezius pain threshold (an average for the right and left trapezii) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
1406555|NCT01207453|Secondary|Thumbnail Pain Threshold|A measure of the change in thumbnail pain threshold from baseline to 6 weeks. Thumbnail pain threshold was determined by applying pressure to a subjectt's thumbnail until the subject felt pain. The difference between the average thumbnail pain threshold (an average for the right and left thumbs) at baseline was compared to that at 6 months. Pain threshold was measured in kg/cm^2. The difference in threshold could range from 0-11 kg/cm^2. A higher difference between thresholds indicates improved pain sensitivity.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
1406556|NCT01207453|Secondary|Symptom Intensity Scale (SIS)|A measure of the change in SIS score from baseline to 6 weeks. The SIS score ranges from 0-9.75, with high scores being worse indicating more widespread pain and fatigue.|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
1406557|NCT01207453|Secondary|Change in Conditioned Pain Modulation (CPM)|CPM is defined as the difference between pain threshold A (measured after a conditioning stimulus activates pathways that inhibit pain) and pain threshold B (measured before the conditioning stimulus is applied). The conditioning stimulus was immersion of the hand in a cold water bath. Pressure pain threshold was assessed at the trapezius muscle initially. Subjects were then instructed to immerse their hand in a water bath for 30 seconds. At 20 seconds, pressure pain threshold at the trapezius was assessed again. We defined the magnitude of subjects’ CPM as the difference in pressure pain threshold between baseline and 20 seconds after cold water immersion. This difference was compared to that measured at 6 weeks. The scale for the difference in CPM ranged from 0-11 kg/cm^2, with 0 indicating no change in CPM between 6 weeks and baseline and 11 indicating the maximum possible change. A greater change in CPM between baseline and 6 weeks is indicative of improvements in CPM.|Baseline to 6 weeks||||kg/cm^2||Standard Deviation|Mean
1406558|NCT01207453|Primary|Brief Pain Inventory (BPI) Change|"A measure of change in scores on the BPI short form, a 24-hr average pain item, from baseline to 6 weeks, The BPI short form scores ranges from 0-10, with 10 being the worst pain."|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
1406559|NCT01207427|Primary|Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment|An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.|Baseline, Weeks 1 through 4 of treatment|All participants who were randomized to study treatment and had at least 1 evaluable SBM post-dose measurement during the Double-blind Period. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.|||Number of SBMs/week||Standard Error|Mean
1406560|NCT01207414|Secondary|Change From Baseline in Integrated Clinical Global Impression of Severity (I-CGI-S) at Week 12|I-CGI-S incorporated the overall, combined impression of illness severity based upon the E-CGI-S and ST-CGI-S. Medically qualified raters evaluated the patient's illness in the previous 7 days at Baseline and Week 12 on a scale of 1 to 7 (1=normal not at all ill, 2=borderline mental illness or impairment, 3=mildly ill or impaired, 4=moderately ill or impaired, 5=marked ill or impaired, 6= severely ill or impaired or 7=among the most extremely ill patients. A negative change from baseline indicates improvement.|Baseline, Week 12||||Score on a scale||Standard Deviation|Mean
1406561|NCT01207414|Secondary|Change From Baseline in the Safety and Tolerability Clinical Global Impression of Severity (ST-CGI-S) at Week 12|Medically qualified raters used the ST-CGI-S at Baseline and Week 12 to evaluate safety and tolerability in the previous 7 days on a scale of 1 to 7 (1=Normal-no symptoms, 2=borderline severity, 3=mild impairment, 4=moderate, 5=marked, 6=severe, 7=among the most severe.) A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1406597|NCT01206582|Secondary|Leukocyte and Platelet Counts|Measured by complete blood count|baseline, Day 4, Day 7, Day 56||||number x 10^9 cells/L||Standard Error|Mean
1406598|NCT01206582|Secondary|Erythrocyte Count|Measured by complete blood count|baseline, Day 4, Day 7, Day 56||||number x 10^12 erythrocytes/L||Standard Error|Mean
1406599|NCT01206582|Secondary|Hemoglobin|Measured by complete blood count|baseline, Day 4, Day 7, Day 56||||g/dL||Standard Error|Mean
1406600|NCT01206582|Secondary|Activated Partial Thromboplastin Time (APTT)||baseline, Day 4, Day 7, Day 56||||Seconds||Standard Error|Mean
1406562|NCT01207414|Secondary|Change From Baseline in the Efficacy Clinical Global Impression of Severity (E-CGI-S) at Week 12|Medically qualified raters use the E-CGI-S scale at Baseline and Week 12 to assess the effectiveness of treatment by examining changes in positive symptoms [hallucinations (false perceptions), delusions (false beliefs), paranoia (unfounded distrust), conceptual disorganization (loosening of associations), or hostility], negative symptoms [apathy (lack of interest), avolition (lack of motivation), alogia (poverty of speech), and anhedonia (absence of pleasure)] and cognitive symptoms [concentration difficulties, difficulties with executive function (integrative reasoning), and illogical thinking] in the previous 7 days on a scale of 1 to 7 (1=normal, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill or 7=among the most extremely ill). A negative change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1406563|NCT01207414|Secondary|Number of Participants With Adverse Events, Serious Adverse Events or Death|"Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen.~Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.~Additional information about adverse events can be found in the Adverse Event section."|12 Weeks|Participants from the Safety Analysis Set- all randomized participants who received study drug (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.|||Participants|||Number
1406564|NCT01207414|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 12|The TSQM consisted of 14 questions about the patient's satisfaction with the drug in 4 domains: Effectiveness [3 questions scored as 1(extremely dissatisfied) to 7(extremely satisfied)], Side Effects [question 4 scored as 0(no) or 1(yes);question 5 scored as 1(extremely bothersome) to 5(not at all bothersome);questions 6 - 8 scored as 1(a great deal) to 5(not at all)], Convenience [questions 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy);question 11 scored as 1(extremely inconvenient) to 5 (extremely convenient)] and Global Satisfaction [question 12 scored as 1(not at all confident) to 7(extremely confident);question 13 scored as 1(not at all certain) to 5(extremely certain);question 14 scored as 1(extremely dissatisfied) to 5(extremely satisfied)]. The scores of each of the domains were added together and an algorithm used to create a score of 0 to 100. Higher scores for each domain indicate a better outcome. A positive change from baseline indicates improvement.|Baseline, Week 12|Participants from the Full Analysis Set with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1406565|NCT01207414|Primary|Integrated Clinical Global Impression of Change (I-CGI-C) at Week 12|The I-CGI-C at Week 12 was the overall impression of medically qualified raters using three separate Clinical Global Impression of Change scales: efficacy (E-CGI-C); safety and tolerability (ST-CGI-S); and overall severity (I-CGI-S) combined for a total score. The I-CGI-C scale ranged from 1 to 7 with lower scores indicating improvement (1=very much improved, 2=much improved, 3=minimally improved), higher scores indicating worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicating no change.|Week 12|Participants from the Full Analysis Set (three cohorts combined: risperidone, olanzapine or aripiprazole) with data available for analyses.|||Score on a scale||Standard Deviation|Mean
1406566|NCT01207401|Primary|Median Visual Analogue Score Measuring Pain|"We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points:~Speculum placement~Tenaculum placement~Paracervical block administration(if subject is in this arm)~IUD insertion~Five minutes post procedure"|1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure||||units on a scale||Full Range|Median
1406567|NCT01207388|Secondary|Resource Utilization||5 years||2020-01-31|01/2020||||
1406568|NCT01207388|Secondary|Change From Baseline in EuroQoL 5-Dimension (EQ-5D) Scales|The EQ-5D is a self-administered questionnaire which captures 3 basic types of information: a descriptive profile (health state index) and the overall health rating using a visual analog scale. The health state index measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression on scales from no problems (score = 1), some problems (score = 2), to extreme problems (score = 3). For each dimension the mean change from baseline was calculated at the end of each treatment cycle and at the end of study. The maximum observed change from baseline during cycles 1 to 4 and the change from baseline at the end of study are reported for each dimension.|Subjects are assessed at Screening Visit (Baseline), at day 29 of each treatment cycle, at Day 30 Safety Follow-Up Visit and during mandated Efficacy Follow-Up Visits occurring at month 3, 6, 9, 12, 18 and 24 after treatment start.|Full analysis set|||units on a scale||Standard Error|Mean
1406569|NCT01207388|Secondary|Change From Baseline in EORTC-QLQ-C30 Scales|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact).~For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.~The maximum changes from baseline to cycles 1 through 4 and to the end of the core study are reported."|Subjects are assessed at Screening Visit (Baseline), at day 29 of each treatment cycle, at Day 30 Safety Follow-Up Visit and during mandated Efficacy Follow-Up Visits occurring at month 3, 6, 9, 12, 18 and 24 after treatment start.|Full analysis set|||units on a scale||Standard Error|Mean
1406601|NCT01206582|Secondary|Prothrombin Time||baseline, Day 4, Day 7, Day 56||||International Normalized Ratio (INR)||Standard Error|Mean
1406602|NCT01206582|Secondary|Serum Creatinine||baseline, Day 4, Day 7, Day 56||||mg/dL||Standard Error|Mean
1406655|NCT01205828|Primary|Clinical Benefit Rate|complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria|8 weeks||||participants|||Number
1406570|NCT01207388|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows:~Grade 1 – Mild AE; Grade 2 – Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~An AE was considered “serious” if it resulted in death, was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions, was a congenital anomaly or birth defect or was a medically important condition."|From the first dose of blinatumomab until 30 days after last dose. Adverse events are reported up to the data cut-off date of 05 August 2015; the median treatment duration was 55 days.|All participants who received any infusion of blinatumomab.|||participants|||Number
1406571|NCT01207388|Secondary|Change in MRD Level From Baseline to End of Cycle 1 in Non-MRD Responders|MRD level was measured by polymerase chain reaction (PCR) performed on bone marrow and assessed by the central laboratory. An MRD level of 10^-n corresponds to residual leukemia cells at a frequency of 1 per 10ⁿ bone marrow cells.|Baseline and end of cycle 1 (6 weeks)|Full analysis set participants who were in hematological complete remission at treatment start, with no MRD Response in the first treatment cycle, excluding Philadelphia-positive participants.|||participants|||Number
1406572|NCT01207388|Secondary|Duration of Complete MRD Response|"The duration of MRD response was analyzed as the time from onset of MRD negativity until MRD or hematological relapse or date of last confirmation of negative MRD status. Participants who received chemotherapy or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse were censored at the start of chemotherapy or HSCT, respectively.~MRD relapse is defined as the reappearance of individual rearrangements of Ig- or TCR-genes ≥ lower limit of quantification (LLOQ) for at least 1 individual marker measured by an assay with a sensitivity of minimum 10^-4. Hematological relapse is defined as the unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological or microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia."|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants, who had an MRD complete response at cycle 1|||months||95% Confidence Interval|Median
1406573|NCT01207388|Secondary|Time to Hematological Relapse|Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.|||months||95% Confidence Interval|Median
1406574|NCT01207388|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.|100 days after HSCT, as of the data cut-off date of 05 August 2015|Full analysis set participants who underwent HSCT prior to relapse (hematological or extramedullary) excluding Philadelphia-positive participants|||percentage of participants||95% Confidence Interval|Number
1406575|NCT01207388|Secondary|Overall Survival|Overall survival was measured from the first treatment with blinatumomab until death due to any cause. Participants who did not die were censored at their last contact date.|Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.|Full analysis set|||months||95% Confidence Interval|Median
1406576|NCT01207388|Secondary|Hematological Relapse-free Survival (RFS)|"Hematological RFS was measured from first dose of blinatumomab until the first assessment of documented relapse (either hematological or extramedullary), secondary leukemia, or death due to any cause. Participants without a documented relapse, or death due to any cause were censored at the time of their last hematological assessment. Participants who received chemotherapy for relapsed or persistent MRD or for any other reason after treatment with blinatumomab, or HSCT after treatment with blinatumomab, before hematological or extramedullary relapse, or death occurred were censored at the start of chemotherapy or HSCT, respectively.~Hematological relapse was defined as unequivocal detection of > 5% leukemia cells in bone marrow as measured by cytological, microscopic assessment, presence of circulating leukemia blasts, or extramedullary leukemia (whichever occurred first).~The 18-month Kaplan-Meier estimate of hematological RFS is reported."|18 months|Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.|||percentage of participants||95% Confidence Interval|Number
1406577|NCT01207388|Primary|Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle|"At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.~Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle."|During the first cycle (6 weeks)|Primary endpoint full analysis set (Prim EP FAS) included all participants with an Ig TCR PCR MRD assay with the minimum required sensitivity of 1 x 10^-4 at central lab established at Baseline.|||percentage of participants||95% Confidence Interval|Number
1406578|NCT01207219|Secondary|Severity of Symptoms|PANSS total score is computed by summing the scores of positive, negative and general symptom subscores. The range of PANSS total score is from 30 to 210, range of PANSS positive and negative subscores is from 7 to 49, range of PANSS general symptoms subscore is from 16 to 112, with higher values representing worse outcome. CDS total score is computed by summing the scores of nine items of the scale. The range of CDS total score is from 0 to 27, with higher values representing worse outcome.|Baseline and 12 weeks|One subject in the waitlist control group has not completed all measures both at the baseline and 12 weeks. Measure of clinical severity has been missing in the data set. So that there are 37 subjects' data of clinical severity has been included for analysis.|||units on a scale||Standard Deviation|Mean
1406614|NCT01206465|Secondary|Time to Disease Progression in All Participants||restaging imaging done after each two 4-week course until time of progression (longest time to progression = 588 days)||||days||Full Range|Median
1406579|NCT01207219|Primary|Attention and Concentration|measured by Letter Cancellation test Q score. The basic version of the task consists of six 52-character rows in which the target character is randomly interspersed approximately 18 times in each row. Subjects were asked to cancel the letter “C” and “E” as quickly as possible. The time to completion, number of error and omission items were recorded. A “quality of search” index (Q), developed by Geldmacher et al., was applied for the analysis. Q is the ratio of correct number to total number of targets multiplied by the ratio of correct number per second. Higher Q scores represent more efficient performance and better attention and concentration. Q scores could range from 0 (worst possible outcome) to 1 (best possible outcome).|baseline and 12 weeks||||Correct number per second||Standard Deviation|Mean
1406580|NCT01207219|Primary|Working Memory|measured by Digit Span backwards test. In this test, the subject was asked to recall a series of numbers in reverse order. The correctly recalled series were scored as 1, and the test contains 14 sequences of numbers. The range of working memory score is from 0 to 14, with higher values representing better outcome.|baseline and 12 weeks||||Scores on a scale||Standard Deviation|Mean
1406581|NCT01207219|Primary|Verbal Retention|The total number of correctly recalled words after short-term (10 minutes) and long-term (30 minutes) delay in the random condition of Hong Kong List Learning test.|baseline and 12 weeks||||correctly recorded words||Standard Deviation|Mean
1406582|NCT01207219|Primary|Verbal Acquisition|Total number of corrected encoded words in the first three trials in the random condition of Hong Kong List Learning test.|baseline and 12 weeks||||correctly encoded words||Standard Deviation|Mean
1406583|NCT01207102|Secondary|"To Assess the Safety and Tolerability of a Combination Regimen of Weekly Abraxane® and Carboplatin to Treat Women With Triple Negative Stage IV Metastatic Breast Cancer"|The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals.|2 years|Due to insufficient accrual, data analysis was not performed.||||||
1406584|NCT01207102|Primary|PFS|The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.|PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first|Due to insufficient accrual, data analysis was not performed.||||||
1406585|NCT01206777|Secondary|Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice|Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice.|6 months, as a before and after infusion survey|Post infusion surveys were collected and de-identified by assignment of an individual nurse identification number|||percentage of nurses satisfied|||Number
1406586|NCT01206777|Secondary|Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule||Determined from difference in expected time by package insert administration and actual time on day of treatment||||minutes for rapid R infusion||95% Confidence Interval|Mean
1406587|NCT01206777|Primary|Incidence of Grade III and IV Hypersensitivity Reactions||Every 15 minutes from start of infusion until completion, for up to 1 hour||||percentage of patients|||Number
1406588|NCT01206738|Primary|Email vs Postal Recruitment: Number of GPs Completing the First Questionnaire|GPs were randomly allocated to receive their invitation to take part by email or by post. Outcome measure was proportion of GPs responding by completing the first questionnaire|27/1/20111 - 15/5/2011|880 physicians received email and 880 received postal invitations. 138 and 132 responded respectively.|||participants|||Number
1406589|NCT01206738|Primary|Number of Simulated Scenarios Where an Antibiotic Was Not Prescribed|Eight simulated clinical scenarios where presented to the GP and he/she was asked whether an antibiotic should be prescribed. The outcome measures was the number of scenarios where an antibiotic was not prescribed.|Immediately after completion of questionnaire||||scenarios||Standard Deviation|Mean
1406590|NCT01206660|Secondary|Physician’s Global Assessment (PGA) of Psoriasis Score at Day 28.|Physician Global Assessment (PGA) of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.|Day 28|ITT Population. Participants who returned for at least one post baseline visit and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||units on a scale||Standard Deviation|Mean
1406591|NCT01206660|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS) for each the three signs and symptoms (erythema, scaling and plaque elevation).|Day 28||||participants|||Number
1406592|NCT01206660|Primary|Clinical Success ITT|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Analysis was conducted using Intent-to-Treat (ITT)|||participants|||Number
1406593|NCT01206608|Secondary|Number of Participants With Adverse Events|Adverse events were monitored through Day 8 and serious adverse events through Day 30.|Through 30 days postdose|||||||
1406594|NCT01206608|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores|Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.|Through 96 hours postdose||||Units on a scale*hours||Standard Deviation|Mean
1406595|NCT01206595|Secondary|Number of Patients With Adverse Events|All adverse events were to be recorded from the time of dosing through Day 8. Serious adverse events (SAEs) were to be recorded through Day 30.|Through 30 days postdose|||||||
1406596|NCT01206595|Primary|Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical pain.|Through 96 hours postdose||||hours||Inter-Quartile Range|Median
1406603|NCT01206582|Secondary|Autonomic Functions|Subjects completed a standardized autonomic symptom questionnaire, the Composite Autonomic Severity Score (CASS) which consists of 2 subscores: cardiovagal (CASS-vag; 0-3) and adrenergic (CASS-adr;0-3), where 0, 1, 2, 3 represent non, mild, moderate, and severe dysfunction, respectively.|baseline, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||units on a scale||Standard Error|Mean
1406604|NCT01206582|Secondary|Gastrointestinal Symptoms|Subjects recorded their GI symptoms every day in the validated Gastroparesis Cardinal Symptom Index (GCSI) - Daily Diary. For each subject, the daily GCSI data were averaged per week. Components coded 0 (no symptoms) to 5 (very severe). GCSI total score is the average of 9 components from the nausea/vomiting, fullness/early satiety, and bloating subscores. These individual subscores are averages of 3,4, and 2 components, respectively. Subscores for upper and lower abdominal pain, heartburn/regurgitation and FDA nausea, vomiting, fullness, and pain (NVFP) composite are averages of 2, 2, 7, and 4 components, respectively.|baseline, 8 weeks|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||units on a scale||Standard Error|Mean
1406605|NCT01206582|Primary|Gastric Emptying Half-time|The time for half of the ingested solids or liquids to leave the stomach. Gastric emptying was assessed with ^13C Spirulina Breath Test. After an overnight fast, subjects consumed the test meal containing ^13C Spirulina. Breath samples were collected in duplicate glass tube using a straw to blow into the bottom of the tube to displace contained air. The ^13CO_2 content of the breath was determined by AB Diagnostics. The provide of ^13CO_2 excretion is used to estimate the half-time of gastric emptying.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||minutes||Standard Error|Mean
1406606|NCT01206582|Primary|Venous Monocyte HO1 Activity|HO1 activity in white blood cells was measured by an assay that measures bilirubin production as a marker of HO1 activity.|baseline, Day 3, Day 7, Day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||pmol bilirubin/mg/h||Standard Error|Mean
1406607|NCT01206582|Primary|Venous Plasma Heme-oxygenase 1 (HO1) Protein Concentration|HO1 protein concentration levels in plasma were assessed with a HO1 (human) enzyme-linked immunosorbent assay (ELISA) kit.|baseline, day 3, day 7, day 56|Total number of subjects analyzed varied per time period due to discontinuations, subject and data availability. Subjects analyzed are presented per category as (n=hemin, albumin arms).|||ng/mL||Standard Error|Mean
1406608|NCT01206517|Primary|Terminal Phase (Elimination) Half-life (t1/2) of Asenapine|Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||hr||Standard Deviation|Mean
1406609|NCT01206517|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post Dose (AUC0-12) of Asenapine|AUC0-12 is the area under the plasma drug-concentration time curve calculated for the 12 hour interval after dosing.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6 and 12 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||hr*ng/mL||Standard Deviation|Mean
1406610|NCT01206517|Primary|Time to Maximum Plasma Concentration (Tmax) of Asenapine|tmax is the time from dosing to maximum plasma drug concentration levels.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||hr||Full Range|Median
1406611|NCT01206517|Primary|Maximum Plasma Concentration (Cmax) of Asenapine|Cmax is the peak plasma concentration following a dose of the study drug.|Predose (0 hours) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36 and 48 hours after the final asenapine dose (administered on Day 7 for Cohorts 1 and 2; on Day 8 for Cohorts 3b, 3c and 3d; and on Day 12 for Cohort 3a)|All participants administered asenapine with evaluable pharmacokinetic data. Two participants in Cohort 3a and one participant in Cohort 3c did not complete the study and are excluded from pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1406612|NCT01206478|Secondary|Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores|Non-communicating Children’s Pain Checklist - Revised (NCCPC-R) used to measure outcome. The NCCPC-R is a 30 item measure intended to assess pain in children who are unable to speak because of cognitive or physical impairments. There are 7 sub-scales including vocal, social, facial, activity, body/limbs, physiological, and eating/sleeping. Each question has a potential score of 0 to 3. Scores are totaled for each sub-scale. Sub-scale scores are then added together for the Total Score. Total Scores can range from 0 to 90. The higher the score, the higher level of pain indicated by the child. This measure was completed by parents at week 0, week 10, and week 24.|baseline, 24 weeks||||units on a scale||Standard Deviation|Mean
1406613|NCT01206478|Primary|% Calories Taken Orally|Percent Kilocalories (kcal) Obtained Orally. This measure was obtained using the 24 hour food recall, a standardized five-pass method developed by the US Department of Agriculture for use in national dietary surveillance. This measure has been widely used in several large trials and data suggest it is the most valid and reliable method of dietary assessment for children (20). The data were collected at week 0, week 10, and week 24 using standardized probes by highly trained research staff, and parents were presented with paper food models and measuring devices prior to interviews to reference during the recall. Recalls were analyzed with the Nutritional Data System for Research, version 2005; University of Minnesota, Minneapolis, MN.|baseline, 24 weeks||||change in percent kcal obtained orally||Standard Deviation|Mean
1406623|NCT01206452|Secondary|Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months|Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 3 months up to 6 months post-procedure||||Participants with AF recurrence|||Number
1406624|NCT01206452|Secondary|Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months|Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 0 months up to 3 months post procedure||||Participants with AF recurrence|||Number
1406625|NCT01206452|Primary|Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months|Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.|From 6 months up to 12 months post-procedure||||Participants with AF recurrence|||Number
1406626|NCT01206439|Secondary|Exercise Tolerance|Changes in exercise tolerance and time from baseline to 180 days.|Baseline to day 180.|||||||
1406627|NCT01206439|Primary|Change in Systolic and Diastolic Myocardial Function|Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.|Baseline to day 180|Insufficient data to analyze.||||||
1406628|NCT01206387|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28|"Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis~The Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~For the %Body Surface Area Affected the Rule of Nine was be used.~Change From Baseline in Percent Body Surface Area i.e., difference of base percent values [Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline]."|Baseline and day 28|Base on intention to treat. All participant with Mean Change from Baseline in %BSA affected at Day 28|||percentage of body surface area affected||Standard Deviation|Mean
1406629|NCT01206387|Secondary|Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)|"Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT)~TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation~The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance."|Baseline and day 28|Base on intention to treat. All participant with mean change from baseline in TLSS at Day 28|||units on a scale||Standard Deviation|Mean
1406630|NCT01206387|Secondary|Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.|"In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges).~The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p<0.05), then PGA change from baseline values was examined."|Baseline and day 28|All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed|||units on a scale||Standard Deviation|Mean
1406631|NCT01206387|Primary|Treatment Success|A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).|28 days||||participants|||Number
1406632|NCT01206387|Primary|Clinical Success|A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).|28 days|Primary Efficacy Analysis at Day 28 Clinical Success (ITT)|||participants|||Number
1406633|NCT01206322|Primary|Perfusion Outcome: Right Insular Cortex Perfusion (ml/100g/Min/mmHg)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg)."|Acute changes within 2 hours||||ml/100g/min/mmHg||Standard Deviation|Mean
1406634|NCT01206322|Primary|Cognitive Outcome: Brief Visuospatial Spatial Memory Test -Total Recall (Unit T Score)|"To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on cognition and regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups.~Cognitive outcome: Brief Visuospatial Spatial Memory test -Total Recall (unit T Score).~Perfusion outcome: Regional vasoreactivity (ml/100g/min/mmHg).~Each participant received a single dose of intranasal insulin (INI) or placebo on day 2 and a single dose dose of insulin or placebo on day 3 in a random order.~Acute effects on baseline perfusion, regional vasoreactivity and cognition were determined within 2 hours after administration of insulin or placebo."|Acute changes within 2 hours||||T-score||Standard Deviation|Mean
1406635|NCT01206140|Secondary|4 -Month Progression-free Survival Rate.|Progression-free survival rate was calculated using the survival distribution function, and 95% confidence limits were calculated using the log-log transformation. Progression was defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Four months||||percent of participants||95% Confidence Interval|Number
1406636|NCT01206140|Secondary|Number of Participants With Objective Response|Response evaluated using the Choi criteria. CR - disappearance of all lesions and no new lesions; PR - a decrease in size (the sum of longest diameters of target lesions as defined in RECIST) of 10% or more or a decrease in tumor density (HU) of 15% or more on CT and no new lesions and no obvious progression of nonmeasurable disease; SD - does not meet the criteria for CR, PR, or PD and no symptomatic deterioration attributed to tumor progression; PD - an increase in tumor size of 10% or more and does not meet criteria of PR by tumor density (HU) on CT or new lesions or new intratumoral nodules or increase in the size of the existing intratumoral nodules. Objective response = CR+PR.|Evaluated for response after every two cycles, up to 4.5 years.||||participants|||Number
1406637|NCT01206140|Primary|Progression-free Survival|Progression-free survival was estimated using the product-limit method of Kaplan and Meier. Progression wasl evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death.|Until disease progression or death, up to 4.5 years||||months||95% Confidence Interval|Median
1406638|NCT01206101|Secondary|Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)|Change from baseline in glucose level variability and hypoglycaemia at baseline, weekly during liraglutide dose escalation, at 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
1406639|NCT01206101|Secondary|Change in Islet Cell Yield During Culture|Change in islet cell yield from pre-culture to post-culture|From 0 hours pre-culture to 24 hours to 72 hours|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
1406640|NCT01206101|Secondary|Proportion of Insulin-Independent Subjects|Proportion of insulin-independent subjects among all randomised subjects who had one or more transplantations after randomisation|At 52 weeks after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
1406641|NCT01206101|Secondary|Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events|Proportion of subjects with HbA1c below or equal to 6.5% at week 52 that were free from severe hypoglycaemic events|From week 0 to week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
1406642|NCT01206101|Secondary|Number of Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episodes were categorised either as minor (PG<3.1 mmol/L [56 mg/dL]) or severe (subject unable to treat himself/herself).|During week 0 to week 52|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
1406643|NCT01206101|Primary|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant|Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant.|At week 52 after initial transplantation|Full analysis set (FAS) – all randomised subjects who underwent one or more transplantations after randomisation. Due to the premature termination of the trial prior to islet cell transplantation in any randomised subject, no formal statistical analyses were performed.||||||
1406644|NCT01206062|Secondary|Small Vessel Cerebral Ischemic Disease|Additional data are being collected over the next year.|6 years||2018-05-31|05/2018||||
1406645|NCT01206062|Secondary|Decline in Cognitive Function|Additional data are being collected over the next year.|6 years||2018-05-31|05/2018||||
1406646|NCT01206062|Secondary|Dementia|Additional data are being collected over the next year.|6 years||2018-05-31|05/2018||||
1406647|NCT01206062|Secondary|Participants Who Developed End Stage Renal Disease||6 years||||Participants|||Count of Participants
1406648|NCT01206062|Secondary|Number of CKD Participants Who Experienced a 50% Decline From Baseline eGFR||6 years|Participants with CKD at baseline|||Participants|||Count of Participants
1406649|NCT01206062|Secondary|Number of Participants With All-cause Mortality||6 years||||Participants|||Count of Participants
1406650|NCT01206062|Primary|Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death||6 years||||Participants|||Count of Participants
1406651|NCT01205828|Secondary|Biomarker Analysis|To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.|6 months|Since the treatment showed no significant efficacy against HCC, therefore study of biomarker that predict responsiveness of the treatment was not carried out.||||||
1406652|NCT01205828|Secondary|Number of Participants Who Had Grade 3 or 4 Adverse Events|Record of all toxicities graded according to the NCI CTCAE version 3.0|6 months|grade 3 or 4 adverse events|||participants|||Number
1406653|NCT01205828|Secondary|Progression Free Survival|The number of months between a patient's enrollment and his/her disease progression|2 years||||months||95% Confidence Interval|Median
1406654|NCT01205828|Secondary|Overall Survival|the number of months between a patient's enrollment and his/her date of death|2 years||||months||95% Confidence Interval|Median
1406656|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|3 years||||Participants|||Count of Participants
1406657|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|2 years||||Participants|||Count of Participants
1406658|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|1 year||||Participants|||Count of Participants
1406659|NCT01205776|Secondary|Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion|"- Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~-Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft."|In-hospital (≤ 7 days of post index procedure)||||Participants|||Count of Participants
1406660|NCT01205776|Secondary|Number of Participants With Complete Revascularization (Residual = 0)|"Complete anatomic revascularization requires revascularization of all vessels ≥2.0 mm reference vessel diameter with a DS ≥60% (both as measured by core angiographic laboratory analysis).~-While this will be the pre-specified criteria for anatomically significant lesions, sensitivity analysis will be performed using different criteria (e.g. ≥2.5 mm vessels, DS ≥70%, etc.)~From the baseline angiogram, the angiographic core lab will identify and designate those lesions and vessels requiring revascularization in all subjects according to this definition, prior to knowledge of the extent of actual revascularization.~Following PCI, the angiographic core lab will determine the extent of revascularization (vessels with TIMI 2or3 flow post procedure with a core laboratory DS <50% considered successfully revascularized).~Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization."|At Baseline|Not all PCI patients have Baseline and Post-PCI Syntax score assessment.|||Participants|||Count of Participants
1406661|NCT01205776|Secondary|Number of Participants With Major Adverse Events (MAE)|"death~myocardial infarction~stroke~Transfusion of ≥2 units of blood~TIMI major or minor bleeding~major arrhythmia~unplanned coronary revascularization for ischemia~any unplanned surgery or therapeutic radiologic procedure~renal failure~sternal wound dehiscence~infection requiring antibiotics for treatment~intubation for > 48 hours~post-pericardiotomy syndrome"|30 days|ITT Population.|||Participants|||Count of Participants
1406662|NCT01205776|Secondary|Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding|"Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation.~Type 3 Type 3a~Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL~Any transfusion with overt bleeding Type 3b~Overt bleeding plus hemoglobin drop ≥5 g/dL*~Cardiac tamponade~Bleeding requiring surgical intervention for control~Bleeding requiring intravenous vasoactive agents Type 3c~Intracranial hemorrhage~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding"|3 years|ITT Population.|||Participants|||Count of Participants
1406663|NCT01205776|Secondary|Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding|"Type 0: No bleeding Type 1: Bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: Any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation.~Type 3 Type 3a~Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL~Any transfusion with overt bleeding Type 3b~Overt bleeding plus hemoglobin drop ≥5 g/dL*~Cardiac tamponade~Bleeding requiring surgical intervention for control~Bleeding requiring intravenous vasoactive agents Type 3c~Intracranial hemorrhage~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: Fatal bleeding"|30 days|ITT Population.|||Participants|||Count of Participants
1406664|NCT01205776|Secondary|Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding|"Bleeding will be classified by the TIMI hemorrhage classification~Severity:~Major:~Intracranial hemorrhage~A ≥5 g/dL decrease in the hemoglobin concentration~A ≥15% absolute decrease in the hematocrit~Minor:~Observed blood loss:~A ≥ 3 g/dL decrease in the hemoglobin concentration~A ≥ 10% absolute decrease in the hematocrit~No observed blood loss:~A ≥ 4 g/dL decrease in the hemoglobin concentration~A ≥ 12% absolute decrease in the hematocrit~Minimal:~• Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit."|3 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
1406665|NCT01205776|Secondary|Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding|"Bleeding will be classified by the TIMI hemorrhage classification~Severity:~Major:~Intracranial hemorrhage~A ≥5 g/dL decrease in the hemoglobin concentration~A ≥15% absolute decrease in the hematocrit~Minor:~Observed blood loss:~A ≥ 3 g/dL decrease in the hemoglobin concentration~A ≥ 10% absolute decrease in the hematocrit~No observed blood loss:~A ≥ 4 g/dL decrease in the hemoglobin concentration~A ≥ 12% absolute decrease in the hematocrit~Minimal:~• Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit."|30 days|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
1406666|NCT01205776|Secondary|Number of Participants With Requirement for Blood Product Transfusion|"All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows:~Δ Hemoglobin = [baseline Hgb – post-transfusion Hgb] + [number of transfused units];~Δ Hematocrit = [baseline Hct – post-transfusion Hct] + [number of transfused units X 3]."|3 years|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
1406667|NCT01205776|Secondary|Number of Participants With Requirement for Blood Product Transfusion|"All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows:~Δ Hemoglobin = [baseline Hgb – post-transfusion Hgb] + [number of transfused units];~Δ Hematocrit = [baseline Hct – post-transfusion Hct] + [number of transfused units X 3]."|30 days|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
1406668|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 3 years|ITT population.|||Participants|||Count of Participants
1406669|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406670|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406671|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406672|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|0-30 days|ITT population.|||Participants|||Count of Participants
1406673|NCT01205776|Secondary|Number of Participants With Graft Stenosis or Occlusion|Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.|in-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406674|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Very late (>1 year)|ITT population.|||Participants|||Count of Participants
1406675|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Late (>30 days - 1 year)|ITT population.|||Participants|||Count of Participants
1406676|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Early (0-30 days)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406677|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Subacute (1-30 days)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406678|NCT01205776|Secondary|Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable|"Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive thrombus~Occlusive thrombus.~Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|Acute (<= 24 hours)|ITT population.|||Participants|||Count of Participants
1406679|NCT01205776|Secondary|Percentage of Participants With Major Adverse Events (MAE)|Composite of death, myocardial infarction, stroke, transfusion of ≥ 2 units of blood, major arrhythmia, unplanned coronary revascularization for ischemia, any unplanned surgery or radiologic procedure, renal failure, sternal wound dehiscence, infection requiring antibiotics for treatment, intubation for > 48 hours, or post-pericardiotomy syndrome.|in-hospital|ITT Population.|||Percentage of participants|||Number
1406680|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 3 years|ITT population.|||Participants|||Count of Participants
1406681|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406682|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406683|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406684|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|0-30 days|ITT population.|||Participants|||Count of Participants
1406685|NCT01205776|Secondary|Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion;~Ischemic ECG changes at rest in a distribution consistent with the target vessel;~Typical ischemic symptoms referable to the target lesion;~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%;~FFR of the target lesion ≤ 0.80~A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met."|in-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406686|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 3 years|ITT population.|||Participants|||Count of Participants
1406687|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406688|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406689|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406690|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|0-30 days|ITT population.|||Participants|||Count of Participants
1406691|NCT01205776|Secondary|Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)|"A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:~A positive functional study corresponding to the area served by the target lesion; or~Ischemic ECG changes at rest in a distribution consistent with the target vessel; or~Typical ischemic symptoms referable to the target lesion; or~IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the~plaque burden must also be ≥ 60%; or~Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80"|in-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406692|NCT01205776|Secondary|Number of Participants With Disability Following Stroke Event|"In case of an event of stroke disability at 90-days±2 weeks will be an overall measurement of severity of stroke as assessed by modified Rankin Scale (mRS) scale.~Stroke disability will be classified using an adaptation of the modified Rankin Scale as follows, the assessment of which will be based on the Modified Rankin Disability Questionnaire.~Scale 0; No stroke symptoms at all. (May have other complaints) Scale 1; No significant disability; symptoms present but no physical or other limitations.~Scale 2; Slight disability; limitations in participation in usual social roles, but independent for activities of daily living (ADL) Scale 3; Some need for assistance but able to walk without assistance Scale 4; Moderately severe disability; need for assistance with some basic ADL, but not requiring constant care Scale 5; Severe disability; requiring constant nursing care and attention."|90 days ± 2 weeks|ITT population. Analysis population includes subjects who had follow-up data at that time period.|||Participants|||Count of Participants
1406693|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 3 years|ITT population.|||Participants|||Count of Participants
1406694|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406695|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406696|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406697|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|0-30 days|ITT population.|||Participants|||Count of Participants
1406698|NCT01205776|Secondary|Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)|"Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).~Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology.~Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage.~All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic."|in-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406699|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 3 years|ITT population.|||Participants|||Count of Participants
1406700|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406701|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406702|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406703|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0-30 days|ITT population.|||Participants|||Count of Participants
1406704|NCT01205776|Secondary|Number of Participants With Protocol Defined MI|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|In-hospital (≤ 7 days of post index procedure)|ITT population.|||Participants|||Count of Participants
1406705|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 3 years|ITT population.|||Participants|||Count of Participants
1406706|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406725|NCT01205685|Secondary|Number of Participants With Tumor Response Per RECIST|Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|Every 12 weeks to tumor progression|Patients who were available for measurement of tumor response.|||participants|||Number
1406707|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406708|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406709|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0-30 days|ITT population.|||Participants|||Count of Participants
1406710|NCT01205776|Secondary|Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|in-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406711|NCT01205776|Secondary|Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406712|NCT01205776|Secondary|Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406713|NCT01205776|Secondary|Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406714|NCT01205776|Secondary|Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0-30 days|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406715|NCT01205776|Secondary|Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|in-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406716|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 3 years|ITT population.|||Participants|||Count of Participants
1406717|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 2 years|ITT population.|||Participants|||Count of Participants
1406718|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 1 year|ITT population.|||Participants|||Count of Participants
1406719|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|0 to 6 months|ITT population.|||Participants|||Count of Participants
1406720|NCT01205776|Secondary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|in-hospital (≤ 7 days of index-procedure)|ITT population. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1406721|NCT01205776|Secondary|Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia|"Death:~Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~Non-cardiac death is defined as a death not due to cardiac causes (as defined above).~Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met."|3 years|ITT population.|||Participants|||Count of Participants
1406722|NCT01205776|Secondary|Numberof Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|30 days||||Participants|||Count of Participants
1406723|NCT01205776|Primary|Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke|"All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection)."|3 years||||Participants|||Count of Participants
1406724|NCT01205685|Secondary|Correlative Studies|Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin|< or = to 2 weeks before initiation of Phase II study treatment period|No correlative studies were performed because the study did not move to the Phase II portion||||||
1406726|NCT01205685|Secondary|Safety Profile Based on Number of Patients With Each Worst-grade Toxicity|According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.|Every 4 weeks up to 24 weeks|Patients who received treatment and experienced an adverse event.|||participants|||Number
1406727|NCT01205685|Primary|Anti-tumor Activity of OSI-906|Time to progression measured in months from study entry to date of disease progression|From study entry to 6 months|Patients who received treatment and who were available for determination of disease progression. One patient withdrew after beginning of treatment and was not available for determination of the duration of disease progression.|||months||Full Range|Median
1406728|NCT01205646|Secondary|Changes in Bone Turnover Markers|Changes in bone turnover markers using per cent change of BSAP and NTx|Four weeks after initiating zoledronte therapy|Patients who had both pre-treatment and post-treatment measures of BSAP and NTx.|||percentage of change in bio-marker||Full Range|Median
1406729|NCT01205646|Secondary|Evaluate Changes in Bone Scans|Evaluate changes in bone scans using per cent change in SUVmax.|Four weeks after initiating zoledronate therapy|Sample population|||percentage of change of SUVmax||Full Range|Median
1406730|NCT01205646|Secondary|Evaluate the Change in PSA After Zoledronate Therapy|Evaluate the change in PSA after zoledronate therapy using per cent change.|Four weeks after initiating Zoledronate therapy|All patients who had their PSA measured both before and after therapy.|||percentage of change in PSA||Full Range|Median
1406731|NCT01205646|Primary|PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.|PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a “PET response”. Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.|Within 3 weeks||||Proportion of participants with response||90% Confidence Interval|Number
1406732|NCT01205581|Secondary|Comparison of Geometric Mean Ratios (GMR) by HAI|"GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later.~GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later."|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||Ratio|||Number
1406733|NCT01205581|Secondary|Comparison of Geometric Mean Titer (GMT) by HAI|Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.|Pre-vaccination, post-vaccination and 9 months after vaccination|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||Titers||Full Range|Geometric Mean
1406734|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After Second Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination||||Events|||Number
1406735|NCT01205581|Secondary|Number of Systemic Reactogenicity Events After First Dose|Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.|First 14 days after vaccination||||Events|||Number
1406736|NCT01205581|Secondary|Number of Local Reactogenicity Events After Second Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination||||Events|||Number
1406737|NCT01205581|Secondary|Number of Local Reactogenicity Events After First Dose|Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.|First 14 days after vaccination||||Events|||Number
1406738|NCT01205581|Secondary|Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.|||percentage of participants|||Number
1406739|NCT01205581|Primary|Number of Participants Achieving Seroprotection After Second Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|21 to 42 days after second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||number of participants|||Number
1406740|NCT01205581|Primary|Rate of Seroprotection After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||Percentage of participants|||Number
1406741|NCT01205581|Secondary|Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)|The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.|ALC at baseline and vaccine response at least 21 days after last dose of vaccine|30 participants did not have ALC data collected at baseline evaluation because they had complete blood count (CBC) ordered without differential count.|||percentagae of participants|||Number
1406742|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.~The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine||||percentrage of participants|||Number
1406743|NCT01205581|Secondary|Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD|"The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease.~The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10."|at least 21 days after each dose of vaccine|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||percentage of participants|||Number
1406744|NCT01205581|Secondary|Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD|Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.|From initial vaccine administration through up to 8 months|Adverse events of Fluzone HD and Fluzone are provided as combined data from cancer and HIV patients, since there is no reason to believe one group is more susceptible to adverse events than the other.|||participants|||Number
1406745|NCT01205581|Primary|Rate of Seroconversion After 1 Dose of Vaccine|The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was <10, or a 4-fold rise in HAI titer if the baseline ≥10.|at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose|Two patients in the HIV-HD group were excluded because data was only available at baseline. These 2 patients were lost for follow-up before evaluation for post-vaccine immune response.|||percentage of participants|||Number
1406746|NCT01205568|Secondary|Percent Change in Minimum Lumen Diameter at 3 Months Post-intervention|Late percent change in minimum lumen diameter from pre-intervention to follow-up angiography.|3 months post-intervention|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation.|||percent change|vessels|Standard Deviation|Mean
1406747|NCT01205568|Primary|Acute Change in Minimum Lumen Diameter Immediately Post-intervention|The primary efficacy outcome is the percent change in minimum lumen diameter from pre-intervention to immediately post-intervention as measured by angiography.|Pre-intervention to immediate post-intervention (approximately 10 minutes)|Vessels with resistant Pulmonary Artery Stenosis were identified during catheterization and eligible vessels were randomized to Cutting Balloon or High Pressure Balloon Dilation. Patients had variable number of eligible vessels. Each eligible vessel was randomized at the time of procedure.|||percentage change|vessels|Standard Deviation|Mean
1406748|NCT01205529|Primary|ST Segment Elevation ≥ 1.5 mm in the Right Precordial Leads (V1-V3), Either at Baseline or Manifested After Sodium Channel Block With Intravenous Procainamide|Number of participants who demonstrated ST-segment elevation >1.5mm in the right precordial leads (V1-V3) either at baseline or after sodium channel block with intravenous procainamide infusion.|During (5, 10, 15, 20, 25, 30 minutes after initiating) or up to 15 minutes after completion of intravenous procainamide infusion|Number of subject who had >/= 1.5mm right precordial ST-segment elevation at baseline or with procainamide administration|||Participants|||Count of Participants
1406749|NCT01205503|Secondary|B-type Natriuretic Peptide (BNP) Blood Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of BNP at the 4 time points outlined in protocol for each of the groups. This is a 32-amino acid polypeptide secreted by heart ventricles in response to excessive stretching of cardiomyocytes.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||pg/ml||95% Confidence Interval|Geometric Mean
1406750|NCT01205503|Secondary|Troponin Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of troponin at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||ng/ml||95% Confidence Interval|Geometric Mean
1406751|NCT01205503|Secondary|Plasma HNE Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of the percent change from baseline of Plasma HNE at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
1406752|NCT01205503|Secondary|Protein Carbonyl Percent Changes From Baseline in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of percent changes from baseline of Protein Carbonyl at the 4 time points outlined in the protocol for each group. All measurements after naive baseline were adjusted as percent change from each individual's baseline measure.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||Percent Change from Baseline||95% Confidence Interval|Geometric Mean
1406753|NCT01205503|Primary|TNF-alpha Levels in Patients Receiving Doxorubicin Containing Chemotherapy|Continuous Measure of TNF-alpha at the 4 time points outlined in the protocol for each group.|prior to and 3 hours post doxorubicin and between cycles 1 and 2||||log(pg/ml)||95% Confidence Interval|Geometric Mean
1406754|NCT01205451|Secondary|Mean Change From Baseline in Pulse Rate at the Exit Visit|The pulse rate of participants was recorded. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Screening) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||beats per minute||Standard Deviation|Mean
1406755|NCT01205451|Secondary|Mean Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at the Exit Visit|Systolic blood pressure (SBP) and diastolic BP of participants were measured in the sitting position. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1406756|NCT01205451|Secondary|Number of Participants With Clinically Significant Abnormalities of Urinalysis at the Screening and Exit Visits|Urine samples of participants were collected for urinalysis, including measuring protein, blood, leukocyte, glucose, and urobilinogen. All values out of the normal range were evaluated by the investigator. Classification of clinically significant and not clinically significant was based on the investigator’s clinical judgment; no specific criteria were used.|Screening visit (-Week 1) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Screening and exit visits were analyzed.|||participants|||Number
1406757|NCT01205451|Secondary|Mean Change From Baseline in Serum Blood Urea Nitrogen (BUN), Fasting Blood Glucose (FBG), Sodium, Potassium, Chloride, Total Cholesterol, and Triglyceride Values at the Exit Visit|Blood samples of participants were collected for biochemical tests of BUN, FBG, electrolytes, cholesterol, and triglycerides. The BUN test is primarily used to evaluate kidney function. Electrolytes include sodium, potassium, and chloride. Change from Baseline was calculated as the value at the exit visit minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
1406758|NCT01205451|Secondary|Mean Change From Baseline in Serum Creatinine, Uric Acid, and Total Bilirubin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of creatine, uric acid, and total bilirubin. Creatine and uric acid are evaluated for kidney function. The liver function test includes total bilirubin. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Micromoles per Liter (μmol/L)||Standard Deviation|Mean
1406759|NCT01205451|Secondary|Mean Change From Baseline in Serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (y-GT), and Alkaline Phosphatase (ALP) Values at the Exit Visit|Blood samples of participants were collected and evaluated for liver function, including measuring ALT, AST, y-GT, and ALP. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||International Units per Liter (IU/L)||Standard Deviation|Mean
1406760|NCT01205451|Secondary|Mean Change From Baseline in Total Protein and Albumin Values at the Exit Visit|Blood samples of participants were collected for a biochemical test of total protein and albumin, at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||grams/L||Standard Deviation|Mean
1406761|NCT01205451|Secondary|Mean Change From Baseline in Hematocrit Value at the Exit Visit|The hematocrit, also called packed cell volume or erythrocyte volume fraction, is the volume percentage of red blood cells in the blood. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||percentage||Standard Deviation|Mean
1406762|NCT01205451|Secondary|Mean Change From Baseline in Hemoglobin Content at the Exit Visit|Blood samples of participants were collected and evaluated for hemoglobin at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Grams per Liter (grams/L)||Standard Deviation|Mean
1406763|NCT01205451|Secondary|Mean Change From Baseline in the Percentage of Neutrophils, the Percentage of Lymphocytes, the Percentage of Monocytes, the Percentage of Eosinophils, and the Percentage of Basophils at the Exit Visit|Blood samples of participants were collected and evaluated for the percentage of neutrophils, lymphocytes, monocytes, eosinophils, and basophils comprising the total WBC count in the blood at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||Percentage of the total WBC||Standard Deviation|Mean
1406764|NCT01205451|Secondary|Mean Change From Baseline in White Blood Cell (WBC) and Platelet Count at the Exit Visit|Blood samples of participants were collected and evaluated for WBC count and platelet count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and the exit visit (Week 12 or earlier)|Safety Set Population. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||10^9 cells per Liter||Standard Deviation|Mean
1406765|NCT01205451|Secondary|Mean Change From Baseline in Red Blood Cell (RBC) Count at the Exit Visit|Blood samples of participants were collected and evaluated for RBC count at Baseline and at the exit visit. Change from Baseline was calculated as the value at the exit visit (Week 12 or earlier) minus the value at Baseline.|Baseline (Day 0) and exit visit (Week 12 or earlier)|Safety Set Population: all enrolled and treated participants. Only those participants for whom data were available for both the Baseline and exit visits were analyzed.|||10^12 cells per Liter||Standard Deviation|Mean
1406766|NCT01205451|Secondary|GAS Score as Evaluated by the Care Giver or the Participant at Week 6 and Week 12|The care giver or participant used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, 0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1406767|NCT01205451|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at Week 6 and Week 12|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at Week 6 and Week 12.|Week 6 and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1406768|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for the Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1406769|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. Only those participants who had thumb spasticity were analyzed. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1406770|NCT01205451|Secondary|Change From Baseline at Week 6 and Week 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator or assessor extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1406771|NCT01205451|Secondary|Number of Participants Classified as Wrist Treatment Responders at Week 6 and Week 12|Wrist treatment responders are defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS from Baseline. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||participants|||Number
1406772|NCT01205451|Primary|Change From Baseline at Week 6 and Week 12 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator or assessor extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 or Week 12 was calculated as the value at Week 6 or Week 12 minus the value at Baseline.|Baseline (Day 0), Week 6, and Week 12|Full Analysis Set (FAS) Population: all randomized and treated participants with at least one post-treatment MAS wrist score. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.|||scores on a scale||Standard Deviation|Mean
1406773|NCT01205438|Secondary|Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score)~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug. Non-responder imputation (NRI) included.|||percentage of participants|||Number
1406774|NCT01205438|Secondary|Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline|The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.|Baseline through 52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1406775|NCT01205438|Secondary|Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score|Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
1406776|NCT01205438|Secondary|Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks|An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.|52 weeks|Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 2.5 mg/day at baseline are included.|||percentage of participants|||Number
1406777|NCT01205438|Secondary|Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares|"The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.~Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit."|Baseline through 52 weeks|Zero participants analyzed. Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE flare data was not collected for analysis.||||||
1406778|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores|A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
1406779|NCT01205438|Secondary|Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks|Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100.No worsening defined as increase of ≤ 0.30 points from Baseline.|52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.|||percentage of participants|||Number
1406780|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores|The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.|Baseline, 52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.|||units on a scale||Standard Deviation|Mean
1406781|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)|PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening defined as increase of ≤ 0.30 points from Baseline.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
1406782|NCT01205438|Secondary|Time to First Severe SLE Flare (SFI)|"The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity.~Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1)."|Baseline through 52 weeks|Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis.||||||
1406783|NCT01205438|Secondary|Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score|SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
1406784|NCT01205438|Secondary|Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.|Baseline, 52 weeks|Intention to treat (ITT), Last observation carried (LOCF). LOCF endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||International Units (IU)||Standard Deviation|Mean
1406785|NCT01205438|Secondary|Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52|A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit.|52 weeks|Intention to treat (ITT), only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.|||percentage of participants|||Number
1406819|NCT01205165|Secondary|Number of Participants Achieving Alanine Aminotransferase (ALT) Normalization at Week 52|ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Only those set of participants with a baseline ALT value above the upper limit of the normal range was included in this analysis. The normal range for ALT is 7 to 43 Units/Liter.|At week 52|ITT population|||Participants|||Count of Participants
1406786|NCT01205438|Primary|Percentage of Participants Achieving an SLE Responder Index Response at Week 52|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|Intention to treat (ITT), all randomized participants who received at least one dose of study drug.Non-responder imputation (NRI) included.|||percentage of participants|||Number
1406787|NCT01205399|Secondary|Procedural Time for AlloMax Surgical Graft Placement.|Procedure time will be defined as beginning when the Investigator made the initial incision and ending when the skin closure was completed (skin to skin).|0 Days|All enrolled subjects that could be verified through historical medical record review.|||minutes||Standard Deviation|Mean
1406788|NCT01205399|Secondary|Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.|Complications will be assessed by evaluation of the procedural and device related adverse events (AEs) documented in the subject’s medical files from the time surgery was initiated until the day the subject had a postoperative visit.|9+ Months|All enrolled subjects that could be verified through historical medical record review.|||complication events|||Number
1406789|NCT01205399|Primary|Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft|A recurrent hernia is a hernia, confirmed by the Investigator at any point after surgery, in the same location as the hernia repaired in the index procedure.|9 + Months|All enrolled subjects that could be verified through historical medical record review.|||participants|||Number
1406790|NCT01205269|Secondary|Plasma AZD8683 AUC0-24|Area under the AZD8683 plasma concentration curve from 0 to 24 hours|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.|||nmol*h/L||Full Range|Geometric Mean
1406791|NCT01205269|Secondary|Plasma AZD8683 Cmax|Maximum plasma concentration of AZD8683|0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h|Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics.|||nmol/L||Full Range|Geometric Mean
1406792|NCT01205269|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||ms||Standard Deviation|Mean
1406793|NCT01205269|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||bpm||Standard Deviation|Mean
1406794|NCT01205269|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||bpm||Standard Deviation|Mean
1406795|NCT01205269|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||mmHg||Standard Deviation|Mean
1406796|NCT01205269|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||mmHg||Standard Deviation|Mean
1406797|NCT01205269|Secondary|Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose|Maximum FVC value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
1406798|NCT01205269|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose|Average FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
1406799|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
1406800|NCT01205269|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h|Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables|||L||Standard Deviation|Mean
1406820|NCT01205165|Primary|Mean Log 10 Reduction in Serum Hepatitis B Virus (HBV), Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, where the lower limit of detection was 300 copies/milliliter (mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to week 12 was calculated as the week 12 value minus the baseline value. Baseline was the Day 1 for the study, when participant received study drug. Log 10 reduction implied reduced viral load.|Baseline (Day 1) and Week 12|Intent to treat (ITT). All participants regardless of whether or not the participant completed the planned duration of the study were analyzed with no data exclusions.|||Log10 (copies/mL)||Standard Deviation|Mean
1406801|NCT01205230|Secondary|Number of Participants With the Indicated Event of Dose Limiting Toxicity (DLT)|The following were considered DLTs only while participants were receiving pazopanib co-administered with either ketoconazole or esomeprazole: Grade 4 hematologic toxicities, excluding lymphopenia; and Grade 3/4 non-hematologic toxicities, excluding alopecia and nausea/vomiting/diarrhea for which adequate supportive therapy had not been instituted. Toxicities observed once co-administration of pazopanib with ketoconazole or esomeprazole was complete (after Day 5 of Period 2) could also be considered DLTs if judged to be relevant by the investigator and the GlaxoSmithKline Medical Monitor.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population. Per protocol, a DLT could not occur during single-agent pazopanib administration in Period 1; thus, data were only collected and analyzed for those participants receiving pazopanib co-administered with either ketoconazole or esomeprazole in Period 2.|||participants|||Number
1406802|NCT01205230|Secondary|Number of Participants With the Indicated Grade 3 or 4 Adverse Events (AEs)|AEs were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. Grades range from 0 (no toxicity) to 4 (life-threatening or disabling). A Grade 3 AE is severe; defined as considerable interference with the participant’s daily activities, medical intervention/therapy required, and hospitalization possible. A Grade 4 AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, and hospitalization probable.|From Baseline (Day 1) to a maximum of 4 weeks after the last dose of study drug was administered (on Study Day 12)|All Treated Population: all participants who were enrolled into the study and received at least one dose of study drug|||participants|||Number
1406803|NCT01205230|Secondary|Plasma Ketoconazole Concentration at the Indicated Time Points|Blood samples for the determination of plasma ketoconazole concentrations were collected before (pre-dose [within 60 minutes prior to pazopanib administration]) and after the final pazopanib and ketoconazole dose (fifth dose) during Period 2 at the indicated time points, relative to pazopanib administration (at 1 and 2 hours after pazopanib administration). Blood samples were obtained via peripheral intravenous cannula or central line. Concentrations of ketoconazole were determined in plasma samples using the currently approved analytical methodology.|Day 5 of Period 2 (combination therapy). Blood samples were collected within 60 minutes prior to pazopanib administration and 1 and 2 hours after pazopanib administration.|PK Population|||mcg/mL||Full Range|Mean
1406804|NCT01205230|Secondary|Tmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||hr||Full Range|Median
1406805|NCT01205230|Secondary|Plasma Cmax for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||mcg/mL||95% Confidence Interval|Geometric Mean
1406806|NCT01205230|Secondary|Plasma AUC(0-24) for the Indicated Metabolites of Pazopanib When Administered Alone or in Combination With Ketoconazole and Ezomeprazole|Blood samples for PK analysis of the metabolites of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population. One participant from the Pazopanib + Ketoconazole treatment arm was not analyzed for GSK1071306 due to mishandling of PK samples during shipping. Only those participants providing samples were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
1406807|NCT01205230|Secondary|Plasma Concentration at 24 Hours After Administration (C24) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Pazopanib plasma concentration-time data were analyzed by non-compartmental methods with WinNonlin. Calculations were based on the actual sampling times. From the plasma concentration-time data, the PK parameter C24 was determined.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained 24 hours after administration of pazopanib.|PK Population|||mcg/mL||95% Confidence Interval|Geometric Mean
1406808|NCT01205230|Primary|Time of Occurrence of Cmax (Tmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Nominal data collection time points (TPs) were defined in the protocol; however, the actual data collection TP often differed slightly from the nominal TP for various reasons. This leads to medians and ranges that don't coincide with planned nominal data collection TPs.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||hours (hr)||Full Range|Median
1406809|NCT01205230|Primary|Plasma Maximum Observed Concentration (Cmax) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for PK analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. The concentration-time curve is the result of time points of blood sampling and its measured concentration of pazopanib in the plasma.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|PK Population|||mcg/mL||95% Confidence Interval|Geometric Mean
1406810|NCT01205230|Primary|Plasma Pazopanib Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC[0-24]) of Pazopanib Alone and of Pazopanib in Combination With Ketoconazole and Esomeprazole|Blood samples for pharmacokinetic (PK) analysis of pazopanib were obtained at pre-dose (within 60 minutes prior to pazopanib administration) and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration. From the plasma concentration-time curve, the PK parameter AUC(0-24) was determined by standard non-compartmental analysis using WinNonlin. Plasma AUC(0-24) is a measure of the amount of drug a participant has been exposed to in 24 hours.|Day 7 of Period 1 (monotherapy) and Day 5 (Study Day 12) of Period 2 (combination therapy). Blood samples were obtained within 60 minutes prior to pazopanib administration and at 1, 2, 3, 4, 6, 8, and 24 hours after pazopanib administration.|Pharmacokinetic (PK) Population: all participants who underwent plasma PK sampling and had evaluable PK assay results from at least one analyte|||Hour*micrograms/milliliters (hr*mcg/mL)||95% Confidence Interval|Geometric Mean
1406811|NCT01205165|Secondary|Mean Log 10 Reduction in Serum HBV DNA Level From Baseline to Week 52|HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to Week 52 was calculated as the Week 52 value minus the baseline value. Baseline was the Day 1 for the study when participant received study drug. Log 10 reduction implied reduced viral load|Baseline (Day 1) and Week 52|ITT population|||Log10 (copies/mL)||Standard Deviation|Mean
1406812|NCT01205165|Secondary|Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52|The data for clinical chemical parameters namely sodium, potassium, calcium, phosphorus, total protein, albumin, amylase, creatinine phospho kinase, creatinine, blood urea nitrogen, total bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase, and prothrombin time as per the scheduled assessments and also according to maximum CTC toxicity grade was reported. The data for number of participants with shift in grade for clinical chemistry parameters at Week 12 and Week 52 were reported.|Baseline (Day 1), Week 12 and Week 52|ITT population. Only those participants available at the specified time points were analyzed|||Participants|||Count of Participants
1406813|NCT01205165|Secondary|Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52|The data for hematology parameters was summarized for Hemoglobin, Red blood cells (RBC), Platelets, Neutrophils, Lymphocytes, Monocytes, and Eosinophil as per the scheduled assessments and also according to maximum grade common terminology criteria (CTC) toxicity grade. The data for number of participants with shift in grade for hematology parameters at Week 12 and Week 52 were reported.|Baseline (Day 1), Week 12 and Week 52|ITT population.|||Participants|||Count of Participants
1406814|NCT01205165|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs)|AE is defined as, any untoward medical occurrence in a participant or clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose, results in death; is life threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity, is a congenital anomaly/birth defect or requires medical intervention.|From treatment initiation (Week 0) to follow-up (up to 52 weeks)|ITT population.|||Participants|||Count of Participants
1406815|NCT01205165|Secondary|Number of Participants Achieving ALT Normalization at Week 12|ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. The normal range for ALT is 7-43 Units/Liter. Only those set of participants with a baseline ALT value above the upper limit of the normal range were included in this analysis, done at week 12.|at Week 12|ITT population|||Participants|||Count of Participants
1406816|NCT01205165|Secondary|Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52|The HBeAg loss, defined as the number of participants with an undetectable level of serum HBeAg. The percentage of participants with a HBeAg seroconversion, defined as an undetectable level of serum HBeAg and a detectable level of serum hepatitis B e antibody (HBeAb) at Week 52. The number of participants with HBsAg loss was defined as an undetectable level of serum HBsAg; and those participants with HBsAg seroconversion were defined as an undetectable level of serum HBsAg and a detectable level of serum HBsAb. All these participant were reported at week 52. Only the subset of participants, with above parameters detectable at baseline were included and for participants with post-baseline values missing were considered as non-responders.|Week 52|ITT population. Only the subset of participants with HBeAg and HBsAg positive at baseline (Day 1) was included in the analysis.|||Participants|||Count of Participants
1406817|NCT01205165|Secondary|HBV DNA Levels at Each Collection Timepoint Through Week 52|Serum HBV DNA at different timepoints namely Baseline, Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52 were reported. The HBV DNA copies in the serum were reported in multiples of log 10 copies per mL, detected using Roche COBAS AMPLICOR HBV monitor.|Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52|ITT population. Only those participants available at the specified timepoints were analyzed|||log 10 copies/mL||Standard Deviation|Mean
1406818|NCT01205165|Secondary|Number of Participants Achieving Virological Response at Week 52|Virological response was defined as HBV DNA level < 300 copies/ml in serum. The number of participants achieving these DNA levels were reported.|At Week 52|ITT population.|||Participants|||Count of Participants
1406821|NCT01205152|Secondary|Effect of SC Asfotase Alfa on Respiratory Function|Outcome measure is the shift in the proportion of patients requiring respiratory support at their last assessment in Study ENB-003-08 compared with Baseline. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Participants|||Count of Participants
1406822|NCT01205152|Secondary|Effect of SC Asfotase Alfa on Growth: Height/Length Z-scores|Outcome measure is the change from Baseline in Z-scores for height/length. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Z-score||Full Range|Median
1406823|NCT01205152|Secondary|Effect of SC Asfotase Alfa on Growth: Weight Z-scores|Outcome measure is the change from Baseline in Z-scores for weight. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Z-score||Full Range|Median
1406824|NCT01205152|Secondary|Long-term Pharmacodynamics (PD) of SC Asfotase Alfa: Pyridoxal-5-phosphate (PLP) Levels|Outcome measure is the change from Baseline in pyridoxal-5-phosphate (PLP) levels. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08). Change from Baseline could not be calculated for 2 patients because of non-evaluable samples at Baseline.|||ng/mL||Full Range|Median
1406825|NCT01205152|Secondary|Long-term Pharmacodynamics (PD) of SC Asfotase Alfa: Plasma Inorganic Pyrophosphate (PPi) Levels|Outcome measure is the change from Baseline in plasma inorganic pyrophosphate (PPi) levels. The time period is pre-dose (Baseline from the ENB-002-08 study [NCT00744042]) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies.|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08). Change from Baseline could not be calculated for 3 patients due to non-evaluable samples at Baseline.|||uM||Full Range|Median
1406826|NCT01205152|Primary|Long-term Efficacy of Asfotase Alfa in Treating Rickets in Infants and Young Children With Hypophosphatasia (HPP).|"Outcome measure is the evaluation of radiographic change in rickets severity using a qualitative Radiographic Global Impression of Change (RGI-C) Scale. Skeletal radiographs obtained at the patient's last assessment were compared with skeletal radiographs obtained before initiation of treatment (Baseline in Study ENB-002-08 [NCT00744042]). The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP-associated rickets) to +3 (indicative of complete or near complete healing of HPP-associated rickets).~The time period is pre-dose (Baseline from ENB-002-08 study) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies."|Up to 90 Months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||scores on a scale||Full Range|Median
1406827|NCT01205152|Primary|Long-term Tolerability of Subcutaneous (SC) Asfotase Alfa|Outcome measure is the number of patients with 1 or more treatment-emergent adverse event. The time period is from Baseline in the ENB-003-08 study to the end of the ENB-003-08 study.|84 months|Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)|||Participants|||Count of Participants
1406828|NCT01205126|Secondary|Breakthrough Pain Medication (Rescue Medication) Doses Taken|Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain.|Baseline up to Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy. Redefined LOCF was applied. Here 'N' =number of participants who were evaluated for this outcome measure.|||Doses||Standard Deviation|Mean
1406829|NCT01205126|Secondary|Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
1406830|NCT01205126|Secondary|Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
1406831|NCT01205126|Secondary|Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
1406856|NCT01204697|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the interval (in days) between the date of randomization and death from any cause. Participants alive at the time of the analysis were censored at the date they were last known to be alive. OS was assessed using the Kaplan‐Meier method.|From randomization until death, assessed up to 18 months|FAS population|||months||95% Confidence Interval|Median
1406832|NCT01205126|Secondary|Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|The PPS included all randomly assigned participants who had completed all efficacy evaluations, have good compliance to the protocol without major protocol violations specified and who prematurely discontinued the study due to lack of efficacy were also included. Redefined LOCF was applied.|||Units on a scale||Standard Deviation|Mean
1406833|NCT01205126|Primary|Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29|The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.|Baseline and Day 29|Per protocol set (PPS) included all randomly assigned participants who had completed all efficacy evaluations, and participants who prematurely discontinued the study due to lack of efficacy were also included. Redefined last observation carried forward (LOCF) was applied. Redefined LOCF is LOCF prior to over dose rescue medication.|||Units on a scale||Standard Deviation|Mean
1406834|NCT01205035|Secondary|Angiographic Leakage From Baseline to Month 6 and 12|"Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 6. Also any decreases of angiographic leakage was counted between baseline and 6 month. The same was done between baseline and 12 month.~Any increase of angiographic leakage was counted as a +1. Likewise, any decrease of angiographic leakage was counted as a -1. The sum was calculated based on the number of participants in each arm and the total shown in the outcome. For example: if across the three injected participants for their 6 month visit, two of them showed an increase of angiographic leakage and one showed a decrease, then the outcome would be, (+1) + (+1) + (-1)= +1. Likewise, if the same three participant's 12 month visit showed two with a decrease in leakage and one with no changes in leakage, the outcome would be, (-1) + (-1) + (0)= -2"|Baseline to 6 and baseline to 12 months||||Sum of increases (+1) and decreases (-1)|||Number
1406835|NCT01205035|Secondary|Number of Adverse Events Associated to the Administration of Ranibizumab 2.0mg||Baseline to 6 month, baseline to 9 month and baseline to 12 months||||Number of Adverse Events|||Number
1406836|NCT01205035|Secondary|Change in Standard Central Subfield Thickness (CST) as Measured by OCT From Baseline to 6, 9, and 12 Months|A large decrease in CST thickness may be indicative of a worse clinical outcome. These measurements are done to ensure safety of the participants.|Baseline to 6, 9, and 12 months||||Micrometer||Full Range|Mean
1406837|NCT01205035|Secondary|Change in Visual Acuity From Baseline to Month 6 and From Baseline to 9 Months||Baseline to 6 months and baseline to 9 months||||LogMAR Unit||Full Range|Mean
1406838|NCT01205035|Primary|Visual Acuity Change From Baseline to Month 12 of the Study||Baseline to 12 months||||LogMAR Unit||Full Range|Mean
1406839|NCT01204918|Secondary|Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)|A commonly used instrument originally developed by NIMH and adapted into a self-report instrument. The version of the scale that we plan to use examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. Presented below are counts of people that had experienced the event by 8 weeks.|8 weeks|All subjects are included in the analysis- with the exception of sex specific conditions.|||participants|||Number
1406840|NCT01204918|Secondary|Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline|Responders having at least a 50% improvement in MADRS compared to the baseline in the sequential parallel design|8 weeks therapy||||Participants|||Count of Participants
1406841|NCT01204918|Primary|Change in Montgomery and Asberg Depression Rating Scale (MADRS)|"This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~Usual cutoff points are:~0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|4 weeks of therapy (week 4 to week 8)||||units on a scale||Standard Deviation|Mean
1406842|NCT01204918|Primary|Change in Montgomery and Asberg Depression Rating Scale (MADRS)|"This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~Usual cutoff points are:~0 to 6 – normal/symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression"|4 weeks of therapy (baseline to week 4)||||units on a scale||Standard Deviation|Mean
1406843|NCT01204853|Secondary|Number of Participants With Pharmacokinetic (PK) Parameters at Steady State|The following PK parameters at the steady state were evaluated: maximum observed concentration during the dosing interval (Cmax), time for maximum observed concentration during the dosing interval (Tmax), area under the plasma concentration-time curve over dosing interval tau for multiple dose (AUCtau), terminal elimination half-life (t1/2), apparent clearance (CL/F) and apparent volume of distribution during the terminal elimination phase (Vz/F) at Week 12/Termination (as data permit), and concentration predose during multiple dosing (Ctrough) at Week 2, 4, 8 and 12/Termination.|pre-dose at Week 2, 4, 8, and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24 hours post-dose at Week 12 or study termination|"The PK concentration set was defined as all participants who have at least 1 concentration.~The PK parameter analysis set was defined as all participants who have at least 1 of PK parameters of interest.~Descriptive statistics for PK parameters were not calculated due to a small number of participants."|||Participants|||Number
1406844|NCT01204853|Secondary|Clinical Worsening|Clinical worsening is defined as 1) Hospitalization for worsening pulmonary arterial hypertension, 2) On-study death, 3) Heart-lung or lung transplantation, 4) Atrial septostomy, 5) Addition of the chronic medications for the treatment of worsening pulmonary arterial hypertension, and 6) Initiation of oxygen.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for clinical worsening were not calculated due to a small number of participants."|||Participants|||Number
1406845|NCT01204853|Secondary|Change From Baseline in N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)|Change from baseline in NT-pro BNP is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in NT-pro BNP were not calculated due to a small number of participants."|||pg/mL||Standard Deviation|Mean
1406846|NCT01204853|Secondary|Number of Participants With Haemodynamics Parameters|"The following haemodynamic measurements were assessed: right arterial pressure, pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, left ventricular-end diastolic pressure, cardiac output, systemic arterial blood pressure (systolic, diastolic and mean), and heart rate.~Change from baseline in haemodynamics parameters is calculated as the value at Week 12 minus value at baseline."|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in haemodynamics parameters were not calculated due to a small number of participants."|||Participants|||Number
1406847|NCT01204853|Secondary|Change From Baseline in WHO Functional Class|The change from baseline in WHO functional class was classified into “Improved”, “No change” and “Worsened”. The change from baseline in WHO functional class at Week 12 was to be summarized with frequency count and percentage in each category based on imputed data for missing values at Week 12.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in WHO functional class were not calculated due to a small number of participants."|||Percentage of participants|||Number
1406848|NCT01204853|Primary|Change From Baseline in 6-minute Walk Distance|Change from baseline in 6-minute walk distance is calculated as the value at Week 12 minus value at baseline.|12 weeks|"Efficacy analysis set is defined as all participants who receive at least one dose of the study drug and had efficacy observations at baseline in any efficacy assessments.~Descriptive statistics for change from baseline in 6-minute walk distance were not calculated due to a small number of participants."|||Meters||Standard Deviation|Mean
1406849|NCT01204853|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, severe adverse events, serious adverse events|12 weeks|"Safety analysis set is defined as all participants who receive at least one dose of the study drug.~Descriptive statistics for adverse events were not calculated due to a small number of subjects."|||Participant|||Number
1406850|NCT01204788|Primary|Number of Participants With Infection|Primary outcome is infection (yes/no) where participant without infection found by day 42 patient are counted as 'No' to infection.|Blood draw 2-3 times a week while hospitalized, weekly thereafter. Participant to remain on study 42 days after transfusion.|Outcomes inevaluable due to low recruitment.||||||
1406851|NCT01204775|Primary|Mean Change in HbA1c From Baseline to Week 16||16 week short term treatment period||||percentage||Standard Deviation|Mean
1406852|NCT01204736|Primary|Elbow Extension Strength|Elbow extension strength was measured as the maximum elbow extension moment that subject's could generate. We used an elbow moment transducer to measure elbow moments under isometric (no change in arm posture) conditions. Subjects performed three trials at maximum effort, holding maximum elbow extension for 5 to 7 seconds. The maximum moment was computed as the maximum average moment sustained over a 0.5 second window.|At least one year post surgery||||Newton-Meters|Participants|Standard Deviation|Mean
1406853|NCT01204697|Secondary|Duration of Response (DoR)|Duration of response (DoR) was defined as the interval (in days) from first documentation of a response (CR/PR depending on which occurred first) to the date of the first documentation of disease progression or death from any cause. Participants presenting a response were considered as censored at the date of the last assessment with a documentation of non-progression. DoR (days) = (Date of PD/death ‐ Date of CR/PR) + 1. Assessments were performed according to RECIST Version 1.1. DoR was assessed using the Kaplan‐Meier method. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population. Here, number of participants analyzed signifies those participants who had a best overall response of CR or PR.|||months||95% Confidence Interval|Median
1406854|NCT01204697|Secondary|Percentage of Participants With Disease Control|Disease control was defined as PR, CR, or SD. Participants who did not achieve a CR or PR or SD were counted as non‐responders in the analysis of disease control. According to RECIST Version 1.1, SD was defined as not qualifying for CR, PR, and PD. Detailed definitions of CR and PR are provided in Outcome Measure 4.|From randomization until progressive disease or death, assessed up to 18 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1406855|NCT01204697|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Best overall response (complete response [CR]/partial response [PR]) was defined as the best response recorded from the start of the treatment until disease progression (PD). Best response in this trial was defined as the best response observed at any post-treatment visits. According to RECIST Version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [>=] 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization until progressive disease or death, assessed up to 18 months|FAS population|||percentage of participants||95% Confidence Interval|Number
1406857|NCT01204697|Secondary|Progression-free Survival (PFS)|Progression-free Survival (PFS) was defined as the interval (in days) between the date of randomization and the first documentation of progressive disease or death from any cause. Participants alive and progression-free were considered as censored at the date of the last tumor assessment when the participant was known to be progression‐free. Participants without post‐baseline tumor assessment, but known to be alive, were censored at the time of randomization. PFS (days) = (Date of Event ‐ Date of Randomization) + 1. PFS was assessed using the Kaplan‐Meier method. Detailed definition of PD is provided in Outcome Measure 1.|From randomization until progressive disease or death, assessed up to 18 months|FAS population|||months||95% Confidence Interval|Median
1406858|NCT01204697|Primary|Percentage of Participants Free From Disease Progression or Death at 6 Months|According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).|Month 6|FAS population|||percentage of participants||95% Confidence Interval|Number
1406859|NCT01204671|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1406860|NCT01204671|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1406861|NCT01204671|Secondary|Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs)|Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|From the beginning of the study (Day 0) to study end (Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1406862|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1406863|NCT01204671|Secondary|Number of Days With Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (> =) 37.5 degrees Celsius (°C)].|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Day||Inter-Quartile Range|Median
1406864|NCT01204671|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Subject|||Number
1406865|NCT01204671|Secondary|Number of Days With Solicited Local Symptoms|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Day||Inter-Quartile Range|Median
1406866|NCT01204671|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results.|||Subject|||Number
1406867|NCT01204671|Secondary|Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease|Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using “fold increase” as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1406868|NCT01204671|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subject|||Number
1406869|NCT01204671|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease|A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subject|||Number
1406870|NCT01204671|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subject|||Number
1406871|NCT01204671|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.|At Day 0 (D0), and at Day 21 (D21)|The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1406872|NCT01204658|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|During the entire study period (Months 0-11)|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.|||Subjects|||Number
1406873|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) – Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases.|||Subjects|||Number
1406881|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
1406874|NCT01204658|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) – Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.|||Subjects|||Number
1406875|NCT01204658|Secondary|Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination – Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C.|Within the 7-day (Days 0-6) period post vaccination after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Subjects|||Number
1406876|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Subjects|||Number
1406877|NCT01204658|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Primary Phase of the Study|Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Subjects|||Number
1406878|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Booster Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
1406879|NCT01204658|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Primary Phase of the Study|Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
1406880|NCT01204658|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
1406882|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Booster Phase of the Study|"Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study.~* A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™."|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||mIU/mL||95% Confidence Interval|Geometric Mean
1406883|NCT01204658|Secondary|Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||mIU/mL||95% Confidence Interval|Geometric Mean
1406884|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Booster Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
1406885|NCT01204658|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Primary Phase of the Study|Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
1406886|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Booster Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||IU/mL||95% Confidence Interval|Geometric Mean
1406887|NCT01204658|Secondary|Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Primary Phase of the Study|Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||IU/mL||95% Confidence Interval|Geometric Mean
1406888|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Booster Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)||2050-12-31|12/2050||||
1406889|NCT01204658|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Primary Phase of the Study|Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)||2050-12-31|12/2050||||
1406890|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study. Results for humoral immune response to the opsonophagocytic activity testing for OPA-19A will be updated when validated results become available.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
1406891|NCT01204658|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study. Results for humoral immune response to the opsonophagocytic activity testing for OPA-19A will be updated when validated results become available.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||Titers||95% Confidence Interval|Geometric Mean
1406892|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes – Booster Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
1406893|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Serotypes – Primary Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||µg/mL||95% Confidence Interval|Geometric Mean
1406894|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) – Booster Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
1406895|NCT01204658|Secondary|Antibody Concentrations Against Protein D (Anti-PD) – Primary Phase of the Study|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
1406907|NCT01204398|Primary|DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean|ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.|8 weeks|Full analysis set (FAS) defined as all patients with at least one dose of T80/A5, and for whom baseline and post-baseline ABPM are available.|||mmHg||Standard Deviation|Mean
1406908|NCT01204294|Secondary|Glycosylated Haemoglobin A1c (HbA1c)|The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.|Baseline and 52 weeks|The full analysis set (FAS) comprised all treated patients who had baseline HbA1c measurement and at least one on-treatment HbA1c measurement available|||Percentage||Standard Deviation|Mean
1406896|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Booster Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.|At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
1406897|NCT01204658|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Primary Phase of the Study|Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.|At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)|The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).|||EL.U/mL||95% Confidence Interval|Geometric Mean
1406898|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Percentage of participants|||Number
1406899|NCT01204658|Primary|Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group|Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.|During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Percentage of participants|||Number
1406900|NCT01204658|Primary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination – Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).|Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.|||Subjects|||Number
1406901|NCT01204398|Secondary|Change From Baseline to End of Study in In-clinic Pulse Rate||8 weeks|TS with non-missing data|||beats per minute (bpm)||Standard Deviation|Mean
1406902|NCT01204398|Secondary|Treatment Emergent Adverse Events|Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events|8 weeks|Treated Set (TS) defined as all patients who entered the run-in phase and were treated with T80/A5.|||Participants|||Number
1406903|NCT01204398|Secondary|ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing|DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment|0 and 8 weeks|FAS|||mmHg||Standard Deviation|Mean
1406904|NCT01204398|Secondary|Change From Baseline to End of Study in DBP and SBP|Manually measured in-clinic DBP and SBP|8 weeks|FAS|||mmHg||Standard Deviation|Mean
1406905|NCT01204398|Secondary|Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment|Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.|8 weeks|FAS|||Ratio||Full Range|Median
1406906|NCT01204398|Secondary|Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing|Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5|8 weeks|FAS|||mmHg||Standard Deviation|Mean
1407798|NCT01196104|Secondary|Comparison of Post-prandial Glucose (PPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1406909|NCT01204294|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events|The first drug administration through 7 days after the last drug administration, up to 382 days|The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period|||Patients|||Number
1406910|NCT01204255|Secondary|Side Effects||3 months||||Total number of side effects|||Number
1406911|NCT01204255|Primary|Lorazepam, Diphenyhydramine, Haloperidol Absorption|Level of lorazepam absorption measured by the serum concentration of the drug|4 hours||||ng/ml||Standard Deviation|Mean
1406912|NCT01204203|Secondary|Overall Survival (OS)|Overall Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced death or lost to follow-up.|Baseline up to 28 months|Participants with advanced malignant pleural mesothelioma.|||months||Full Range|Median
1406913|NCT01204203|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the number of days from the day the subject started treatment to the day the subject experienced evidence of disease progression, as determined by radiological or clinical progression.|Baseline up to 28 months|Participants with advanced malignant pleural mesothelioma.|||Months||Full Range|Median
1406914|NCT01204203|Primary|Tumor Response Rate Following Zoledronic Acid (Zometa)|The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.|Baseline up to 28 months or until progressive disease or death|Participants with advanced malignant pleural mesothelioma.|||percentage of responders|||Number
1406915|NCT01203956|Secondary|Key Measures That Will be Used to Evaluate the Intervention(s)|The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device|2 weeks|||||||
1406916|NCT01203956|Primary|Apnea-hypopnea Index (AHI)|Number of apnea/hypopnea events per hour, measured by SmartLink component of device.|4 weeks||||events / hour||Standard Deviation|Mean
1406917|NCT01203930|Secondary|Overall Survival|Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause.|Up to 28 Months|Overall survival analysis was not performed because the follow-up period was insufficient to capture enough events.||||||
1406918|NCT01203930|Secondary|Changes in Potential Pharmacodynamic Markers of Drug Activity in Plasma and Whole Blood|"Changes in potential pharmacodynamic markers of drug activity will include assessments of chemokine and cytokine concentrations, effects on the activity of PI3K and related pathways, and effect on cell migration and other functional outcomes. This endpoint will be assessed at the following time points:~Idelalisib+Rituximab (Cohort 1): Predose and 1.5 hour postdose on Day 1 and predose on Days 15, 29, 57, 113, and 169~Idelalisib (Cohort 2): Predose on Days 1, 29, 57, 141"|Up to 169 days|The collection of plasma samples for pharmacodynamic (PD) analysis in this study was planned prior to the availability of results from an identical PD analysis in another idelalisib study with a larger sample size (n = 176 unique subjects with 2085 longitudinal plasma samples). Therefore, PD analysis was not performed in this study (n = 41).||||||
1406919|NCT01203930|Secondary|Idelalisib Plasma Concentrations (Cohort 2)||Predose and 1.5 hours postdose at Weeks 0 and 4 and predose at Weeks 8 and 20|PK Analysis Set: participants in the ITT Analysis Set from Cohort 2 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.|||ng/mL||Inter-Quartile Range|Median
1406920|NCT01203930|Secondary|Idelalisib Plasma Concentrations (Cohort 1)||Predose and 1.5 hours postdose at Weeks 0, 4, and 24|Pharmacokinetic (PK) Analysis Set: participants in the ITT Analysis Set from Cohort 1 who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.|||ng/mL||Inter-Quartile Range|Median
1406921|NCT01203930|Secondary|Progression-Free Survival|"Progression-free survival (PFS) was defined as the interval from the first dose date of drug to the earlier of the first documentation of definitive disease progression or death from any cause.~Progression was defined using the Standardized IWCLL criteria as specifically modified for this study to consider the mechanism of action of idelalisib and similar drugs. The occurrence of any of the following events indicated progression:~Evidence of any new disease~Evidence of worsening of index lesions, spleen or liver, or non-index disease~Decrease in platelet count or hemoglobin that is attributable to CLL and is confirmed by bone marrow biopsy"|Up to 28 Months|ITT Analysis Set|||months||95% Confidence Interval|Median
1406922|NCT01203930|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.|Up to 28 Months|Participants in the ITT Analysis Set who achieved complete or partial response.|||months||95% Confidence Interval|Median
1406923|NCT01203930|Secondary|Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of All Measurable Lesions||Baseline; Weeks 8, 16, 24, 36, 48, 60, 72, 84, 96, 108, and 120|Participants in the ITT Analysis Set with available data were analyzed.|||percent change||Full Range|Median
1406924|NCT01203930|Secondary|Lymphadenopathy Response Rate|Lymphadenopathy response rate was defined as the percentage of participants with a ≥ 50% reduction from baseline in the sum of the perpendicular diameters of all measurable lesions while receiving study therapy.|Baseline and up to 28 Months|Participants in the ITT Analysis Set with baseline measurable lymph nodes were analyzed.|||percentage of participants||95% Confidence Interval|Number
1406925|NCT01203930|Secondary|Overall Safety of Idelalisib|The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).|Up to 28 Months|ITT Analysis Set|||percentage of participants|||Number
1406954|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination|one month after the second vaccination|Accroding to Protocol set|||participants|||Number
1414534|NCT01144052|Secondary|Number of Infections||12 months||||events|||Number
1406926|NCT01203930|Primary|Overall Response Rate (ORR)|"ORR was assessed based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria as specifically modified for this study to reflect current recommendations which consider the mechanism of action of idelalisib and similar drugs, and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. Based on the CLL response definition in the protocol (modified Hallek 2008), the parameters of lymphadenopathy, liver and/or spleen size, constitutional symptoms, polymorphonuclear leukocytes, circulating clonal B-lymphocytes, platelet count, hemoglobin, and marrow were assessed.~CR: meeting all defined criteria~PR: meeting at least 2 of the criteria of circulating lymphocytes, lymphadenopathy, liver, spleen, or bone marrow (or only lymphadenopathy if liver and spleen normal at baseline) and at least 1 of the criteria for polymorphonuclear leukocytes, platelet count, or hemoglobin."|Up to 28 Months|Intent-to-treat (ITT) Analysis Set: participants who received at least 1 dose of idelalisib.|||percentage of participants||95% Confidence Interval|Number
1406927|NCT01203917|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Months||95% Confidence Interval|Median
1406928|NCT01203917|Other Pre-specified|Progression - Free Survival (PFS) (Independent Central Review)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Months||95% Confidence Interval|Median
1406929|NCT01203917|Secondary|Progression - Free Survival (PFS) (Investigator)|PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Months||95% Confidence Interval|Median
1406930|NCT01203917|Other Pre-specified|Objective Response Rate (ORR) (Independent Central Review))|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
1406931|NCT01203917|Other Pre-specified|Disease Control Rate (DCR) (Independent Central Review)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements of scans by central review.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
1406932|NCT01203917|Secondary|Disease Control Rate (DCR) (Investigator)|DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
1406933|NCT01203917|Primary|Objective Response Rate (ORR) (Investigator)|% of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator.|Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months|Full analysis set, EGFR M+ patients who had taken at least 1 dose of gefitinib|||Percentage of Participants|||Number
1406955|NCT01203189|Secondary|Number of Participants Who Are Very Satisfied|"Patient satisfaction will be measured using a five point satisfaction scale.~very dissatisfied~dissatisfied~Neutral~satisfied~very satisfied."|data were collected at end of each treatment period (4 weeks and 8 weeks)|Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group.|||Participants|||Count of Participants
1406934|NCT01203878|Secondary|Cosmetic Appearance|"Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments:~INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation~1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity"|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 investigator cosmetic appearance score. One imiquimod/observation patient did not have an end of study investigator cosmetic appearance score.|||units on a scale||Standard Deviation|Mean
1406935|NCT01203878|Secondary|Complete Clearance|The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).|Week 18 (4 weeks after randomization visit)|Randomized patients with a week 18 actinic keratosis count.|||participants|||Number
1406936|NCT01203878|Primary|Actinic Keratosis Count|The percent change in actinic keratosis count as compared to the baseline lesion count|Week 18 (4 weeks after randomization visit)|Randomized patients with both a baseline and a week 18 actinic keratosis count. One patient in imiquimod/observation group did not have a baseline count and therefore was not included in the analysis.|||percent reduction in baseline count||Standard Deviation|Mean
1406937|NCT01203852|Secondary|Adverse Metabolic Effects|Change in glucose after treatment with study medication|after 6-8 weeks treatment|All patients with change in glucose data|||mg/dL||Standard Deviation|Mean
1406938|NCT01203852|Primary|Change in Blood Pressure From Baseline to Treatment|Response to blood pressure medication will be assessed by measuring blood pressure before and after treatment|after 6-8 weeks of treatment|All patients with antihypertensive response data. 282 patients completed all 3 study periods. 369 patients completed only period 1. 328 patients completed only period 3.|||mmHg||Standard Deviation|Mean
1406939|NCT01203826|Primary|Skeletal Radiograph Evaluation Using a Qualitative Radiographic Global Impression of Change (RGI-C) Scale Compared to Baseline (Pre-treatment) in Study ENB-006-09.|"Evaluation of radiographic change in rickets severity (as assessed by skeletal radiographs of the hands/wrists and knees) from the Baseline of Study ENB-006-09 (NCT00952484) to the End of Study (EOS) visit in Study ENB-008-10 using an ordinal RGI-C scale score. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP associated rickets) to +3 (indicative of complete or near complete healing of HPP associated rickets).~The time points will be pre-treatment (Baseline from Study ENB-006-09) to the last radiographic assessment in Study ENB-008-10, which represents at least 72 months of treatment."|At least 72 months of treatment with asfotase alfa|Each visit in Study ENB-008-10 was calculated relative to the start of exposure to asfotase alfa in Study ENB-006-09 (NCT00952484); 24 weeks are added to each visit in Study ENB-008-10. Results shown are for the last assessment in Study ENB-008-10 and represent at least 72 months of treatment with asfotase alfa.|||units on a scale||Full Range|Median
1406940|NCT01203787|Secondary|Number of Subjects With Dose Reductions||11/22/2010-3/10/2014||||participants|||Number
1406941|NCT01203787|Secondary|Number of Subjects With Dose Interruptions||Baseline-End of Treatment (11/22/2010-3/10/2014)||||participants|||Number
1406942|NCT01203787|Primary|Cumulative Dose of Sorafenib|Table below shows mean cumulative dose of sorafenib for each of the dosing regimens.|11/22/2010-1/27/14||||mg||Standard Deviation|Mean
1406943|NCT01203787|Secondary|Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 5 adverse events was collected for each dosing regimen beginning at baseline through 6 months of treatment.|11/22/2010-3/10/2014||||Grade 5 Adverse Events|||Number
1406944|NCT01203787|Secondary|Safety of Dosing Regimens as Assessed by the Frequency and Severity of Adverse Events According to National Cancer Institute- CTCAE|The total number of CTCAE (Common Terminology Criteria) grade 4 adverse events was collected for each dosing regimen beginning at baseline until Week 24/Early Termination Visit.|11/22/2010-3/10/2014||||Grade 4 adverse events|||Number
1406945|NCT01203787|Secondary|Safety and Efficacy of Sorafenib Dosing Regimens|Safety of Sorafenib was assessed by the frequency and severity of adverse events according to NCI-CTCAE grading|Baseline-End of Treatment (11/22/2010-3/10/2014)|The total number of CTCAE (Common Terminology Criteria) grade 3 adverse events was collected for each dosing regimen|||Grade 3 adverse events|||Number
1406946|NCT01203787|Primary|Total (Cumulative) Dose Delivery of Sorafenib|This outcome measure table shows the median cumulative dose delivered to the subjects randomized to the standard dosing regimen (N=63) and ramp-up regimen (N=57) at 4 months of treatment.|4 months-1/12/2010-1/27/14||||mg||Full Range|Median
1406947|NCT01203644|Secondary|Adverse Events|Safety assessments included monitoring of treatment-emergent adverse events|Through 30 days postdose|||||||
1406948|NCT01203644|Primary|Time to First Use of Supplemental Pain Medication|The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical wound pain|Through 96 hours postdose||||hours||Inter-Quartile Range|Median
1406949|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after third vaccination|within the first 30 days after third vaccination|||||||
1406950|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after second vaccination|within the first 30 days after second vaccination|||||||
1406951|NCT01203319|Secondary|the Safety of Recombinant Hepatitis B Vaccines in Nonresponders|assessment of the local and systemic adverse reaction within the first 30 days after first vaccination|within the first 30 days after first vaccination|||||||
1406952|NCT01203319|Secondary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after first vaccination|one month after the first vaccination||||participants|||Number
1406953|NCT01203319|Primary|Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders|Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination|one month after the third vaccination||||participants|||Number
1407799|NCT01196104|Secondary|Comparison of Fasting Plasma Glucose (FPG) Levels at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1406956|NCT01203189|Secondary|Number of Participants Who Are Always Compliant.|"Patient compliance will be evaluated by having patients keep a diary documenting the use of study drug. They will also be questioned about their medication usage at every visit. In addition, we will weigh the study drug at every visit.~a patient is classified as always indicates that they use their medicine as directed on their diary on every visit."|at end of each treatment period (4 weeks and 8 weeks)|Data were not collected for the Shampoo Only Group and Foam Only Group at end of 8 weeks. Only 3 participants finished the study in the Cross Over Group.|||Participants|||Count of Participants
1406957|NCT01203189|Primary|Total Dandruff Severity Score (TDSS)|"The scalp will be divided into quadrants and for each quadrant the percent of involvement and degree of severity will be assessed. The percent of involvement will be measured on a scale of 0 to 4 in which a score of 0 means less than 10% involvement, and a score of 4, more than 76% involvement. Severity will be measured on a scale of 0 to 3 in which a score of 0 indicates normal skin, and a score of 3, marked erythema with thick confluent plates of yellowish white scales. The whole scalp score will then calculated by multiplying the total percent involvement score by the total severity score.~Quadrant scalp score = percent involvement score x severity score Total scalp score = summation of all the quadrant scores TDSS value ranges from 0-48, with 0 equal to no scale, which is the best outcome, compared to 48, which is the most severe and worse outcome"|up to 8 weeks|Data were not collected for the Shampoo only group and Foam Only group at 8 weeks. Only 3 participants completed the 8 weeks of cross over treatment.|||units on a scale||Standard Deviation|Mean
1406958|NCT01203098|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment|||percentage of subjects with bleeds||95% Confidence Interval|Number
1406959|NCT01203098|Primary|Percentage of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.|||percent of participants with VTE event||95% Confidence Interval|Number
1406960|NCT01203072|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug|2 weeks|Safety Analysis Set is defined as subjects secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any doses of study drug, or had no safety data after start of study treatment. Subjects with significant GCP violations, but received at least one dose of study drug, safety data were assessed individually|||percentage of subjects with bleeds||95% Confidence Interval|Number
1406961|NCT01203072|Primary|Proportion of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.|||percentage of participants||95% Confidence Interval|Number
1406962|NCT01203046|Primary|Other Complications|Patients with complications different to surgical site infection.|10 days|Patients who presented any complication different of surgical site infection after surgery|||participants|||Number
1406963|NCT01203046|Primary|Surgical Site Infection|The patients were evaluated up to 10 days with close observation of surgical site. We concluded as surgical site infection when inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption was observed.|10 days|All patients with inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption observed at surgical site were included.|||participants|||Number
1406964|NCT01202994|Secondary|Change in Participant Z-score|This z-scores is based on a test of visual learning and memory, which was administered to subjects twice across one week. The amount of change that individuals show across one week is the baseline measure assessed with this variable. We focused on the amount of change observed on the Delayed Recall trial of this test between baseline and one week (i.e., practice effect). The practice effect score on this test is represented as a z-score (M = 0, SD = 1), with higher scores indicating more improvement across one week, which is better result than lower scores.|baseline, one week||||z-score||Standard Deviation|Mean
1406965|NCT01202994|Primary|Amyloid Deposition Obtained on a 18F-flutemetamol Brain Scan.|Standardized Uptake Value Ratio on flutemetamol scan will be the imaging marker of Alzheimer's disease pathology.|Imaging occurred during a single session with each subject.||||ratio of flutemetamol absorbed||Standard Deviation|Mean
1406966|NCT01202955|Secondary|Correct Reaction Time During Attention Task Performance After Overnight Abstinence.|We wanted to examine the effects of Tolcapone on the Continuous Performance Task (attention task) after overnight abstinence as compared to placebo.|30 days|Only participants who completed both study phases were analyzed.|||Milliseconds||Standard Deviation|Mean
1406967|NCT01202955|Secondary|N-back (Working Memory) Correct Reaction Time After Overnight Abstinence.|To obtain preliminary data on the effects of Tolcapone on abstinence-induced neurocognitive deficits in abstinent smokers with differing COMT genotypes. We examined reaction time differences on the n-back task between tolcapone and placebo treatment.|30 days|Only participants who completed both sessions were analysed|||Milliseconds||Standard Deviation|Mean
1406968|NCT01202955|Primary|Number of Eligible Participants Enrolled Who Completed the Study.|Number of enrolled participants who complete the final study visit|30 days|Number of Participants who completed the study.|||Participants|||Number
1406969|NCT01202903|Secondary|Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment|Analysis of rescue medication use followed a similar method to that employed for total asthma symptom score. The mean number of puffs across the 28 days prior to the Week 24 assessment visit was used to calculate a change from baseline. LS Mean of change from baseline in mean number of puffs of asthma rescue medication is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean number of puffs of asthma rescue medication as covariates.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Number of puffs||Standard Error|Least Squares Mean
1406970|NCT01202903|Secondary|Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24|The global evaluation of treatment effectiveness (GETE) is an assessment of asthma symptom control and overall response to asthma treatment. The evaluation was performed by both investigator and patient, each using the same 5 point scale. The GETE scale ranges were as follows: excellent, good, moderate, poor and worsening. A good or excellent response on the 5 point scale indicated that a patient had responded to treatment. 1=excellent 2=good 3=moderate 4=poor 5= worsening. Responder is defined as the patient who achieved an excellent or good response. Non-responder isdefined as the patient who achieved a moderate or poor or worsening response.|16 and 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Percent|||Number
1406971|NCT01202903|Secondary|Change From Baseline in Asthma Symptom Scores Following 24-week Treatment|Total asthma symptom score was derived for each day as the total of the morning (scale 0-1), daytime (scale 0-4) and nocturnal (scale 0-4) scores with a max score of 9. The mean score across the 28 days prior to the week 24 assessment visit was used to calculate a change from baseline. Analysis of total asthma symptom score was performed using ANCOVA model and Van-Elteren test. LS Mean of change from baseline in mean asthma symptom score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean asthma symptom scores as covariates. Decrease of score on change from baseline means improvement of asthma symptom control.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Units on a scale||Standard Error|Least Squares Mean
1406972|NCT01202903|Secondary|Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator’s site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. Only patients with no more than 1 item missing are included, and the missing item was imputed by interpolation|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Percent|||Number
1406973|NCT01202903|Secondary|Change From Baseline in ACQ Score Following 24-week Treatment|The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator’s site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. LS Mean of change from baseline in ACQ score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, center grouping, smoking status, and baseline ACQ score as covariates. Score 0= totally controlled, 6= extremely poorly controlled|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Units on a scale||Standard Error|Least Squares Mean
1406974|NCT01202903|Secondary|Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients’ asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Percent|||Number
1406975|NCT01202903|Secondary|Change From Baseline in AQLQ Score Following 24-week Treatment|The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients’ asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement.|24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||Units on a scale||Standard Error|Least Squares Mean
1410546|NCT01177709|Secondary|Glucose Levels|Fasting glucose|baseline, 4 weeks, 8 weeks, 12 weeks||||mg/dL||Standard Error|Mean
1406976|NCT01202903|Secondary|Change From Baseline in % Predicted FEV1 Following 24-week Treatment|Spirometry was used at defined time points throughout the study to assess the clinical status of patients and to capture the following variables: forced expiratory volume in one second (FEV1), FEV1 percent predicted, forced vital capacity (FVC) and the FEV1/FVC ratio. During the Screening assessment, spirometry was performed pre- and post-bronchodilator administration to assess reversibility. During the treatment period (including prerandomization assessments on Day 1), spirometry was performed after withholding bronchodilators. The results of spirometry were required to meet the ATS/ERS criteria for acceptability and repeatability. Acceptability criteria were applied before repeatability was determined. LS Mean of change from baseline in % predicted FEV1 is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline % predicted FEV1 as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||L/min||Standard Error|Least Squares Mean
1406977|NCT01202903|Secondary|Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||L/min||Standard Error|Least Squares Mean
1406978|NCT01202903|Primary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.|Baseline, 24 weeks|The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days|||L/min||Standard Error|Least Squares Mean
1406979|NCT01202877|Primary|Overall Response (OR) Within 6 Months|Overall response defined as percentage of participants with response as follows: (OR = CR [complete response (CR) rate] + CRi [complete remission with incomplete count recovery] + PR [partial remission] + HI [hematologic improvement]) within 6 months of treatment initiation|6 Months||||percentage of participants|||Number
1406980|NCT01202877|Primary|Participant Best Response Assessed Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|Criteria for response per international working group for Myelodysplastic Syndrome (MDS) & acute myeloid leukemia (AML) where responders obtained a complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: <5% bone marrow blasts, neutrophil count>1.0 X10⁹/L, & platelet count>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (<1.0 X10⁹/L) or thrombocytopenia (<100 X10⁹/L). MLFS: <5% blasts in bone marrow regardless of neutrophil & platelet count in peripheral blood. PR: all CR criteria, except reduction> 50% in bone marrow blasts, but still >5%. Clinical responses evaluated using RECIST version 1.1 criteria after every two cycles, with confirmation of clinical response at 4 weeks after achieving response.|6 months||||participants|||Number
1406981|NCT01202773|Secondary|Change From Baseline to Week 24 in CRP|CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||milligrams/liter (mg/L)||Standard Error|Least Squares Mean
1406982|NCT01202773|Secondary|Percentage of Participants Developing Anti-LY2127399 Antibodies|Participants with treatment-emergent anti-drug antibody (ADA) were participants who had any sample from baseline up to and through Week 52 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA = (number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.|Baseline through Week 24|All randomized participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result. Participants missing an evaluable baseline result with all negative post-baseline results were included. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1406983|NCT01202773|Secondary|Population Pharmacokinetics (PK): Constant Clearance|Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.|Baseline through Week 24|All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliters/hour (mL/h)||Standard Error|Mean
1407064|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Colonization Index||Baseline|Data for prior colonization by colonization index was not analyzed as the study was retrospective and colonization index was not recorded for the participants.||||||
1407800|NCT01196104|Secondary|To Evaluate the Effect of Each Treatment on HbA1c|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1406984|NCT01202773|Secondary|Change From Baseline to Week 24 in Serum Immunoglobulin (Ig) Levels|Immunoglobulin (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable serum Ig data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||grams/liter (g/L)||Standard Error|Least Squares Mean
1406985|NCT01202773|Secondary|Change From Baseline to Week 24 in Absolute B Cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable CD3-CD20+ B cell counts. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||cells/microliter (cells/µL)||Standard Error|Least Squares Mean
1406986|NCT01202773|Secondary|Time to ACR20 Response||Baseline through Week 24|Zero participants analyzed. Time to ACR20 data not collected for analysis.||||||
1406987|NCT01202773|Secondary|Change From Baseline to Week 24 in Duration of Morning Stiffness (Minutes)|The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable morning stiffness data; mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||minutes||Standard Error|Least Squares Mean
1406988|NCT01202773|Secondary|Change From Baseline to Week 24 in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores|The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24 hours and pain based on the pain right now, with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in the past 24 hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable BPI-SF scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1406989|NCT01202773|Secondary|Change From Baseline to Week 24 in Brief Fatigue Inventory (BFI) Individual Items and Impact Scores|The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, the first item is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable BFI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1406990|NCT01202773|Secondary|Change From Baseline to Week 24 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain and Summary Scores|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. If < 50% of the questions within a domain were answered, the raw score were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher score indicating better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable SF-36 domain and summary scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1407006|NCT01202760|Secondary|Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint|CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||milligrams per liter (mg/L)||Standard Error|Least Squares Mean
1408784|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity at 18 Weeks||18 weeks after enrollment||||participants|||Number
1406991|NCT01202773|Secondary|Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response|EULAR Responder index categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP=0.56*sqrt(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response = ( number of participants with specific response) / (number of participants analyzed in the group) * 100.|Baseline through Week 24|All randomized participants with evaluable EULAR response data. Modified Last Observation Carried Forward (mLOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1406992|NCT01202773|Secondary|Change From Baseline to Week 24 in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter), and participant's global assessment of disease activity using VAS (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable DAS28-CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1406993|NCT01202773|Secondary|Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable HAQ-DI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1406994|NCT01202773|Secondary|Change From Baseline to Week 24 in Physician’s Global Assessment of Disease Activity (VAS)|Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable physician's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
1406995|NCT01202773|Secondary|Change From Baseline to Week 24 in Participant’s Global Assessment of Disease Activity (VAS)|Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable participant's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
1406996|NCT01202773|Secondary|Change From Baseline to Week 24 in Participant's Assessment of Pain [Visual Analog Scale (VAS)]|Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable participant's assessment of pain data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
1406997|NCT01202773|Secondary|Change From Baseline to Week 24 in Swollen Joint Count (66 Joint Count)|Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable swollen joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
1406998|NCT01202773|Secondary|Change From Baseline to Week 24 in Tender Joint Count (68 Joint Count)|Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, Week 24|All randomized participants with evaluable tender joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
1407029|NCT01202578|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.|0 days|Device Success is evaluated on a per device basis.|||percentage of devices|Participants|95% Confidence Interval|Number
1415145|NCT01137370|Primary|Median 25-OHD Level||August 2010 to March 2011||2011-10-31|10/2011||||
1406999|NCT01202773|Secondary|American College of Rheumatology Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJC, b) % change in SJC, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline Disease Activity Score based on 28 joint counts -CRP (DAS28-CRP) as a covariate.|Baseline through Week 24|All randomized participants with evaluable ACR-N data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of improvement||Standard Error|Least Squares Mean
1407000|NCT01202773|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response|ACR Responder Index: composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had a ≥50% improvement from baseline in both 68 TJC and 66 SJC and a ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response = [number (No.) of ACR50 responders / No. of Pts treated]*100. ACR70 Responder: had a ≥70% improvement from baseline in both TJC and SJC and a ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response = (No. of ACR70 responders / No. of Pts treated)*100. All NR at Week 16, as well as all Pts who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.|Baseline through Week 24|All randomized participants with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1407001|NCT01202773|Primary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|ACR Responder Index: composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: a ≥20% improvement from baseline in both 68 tender joint counts (TJC) and 66 swollen joint counts (SJC) and a ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response = (number of ACR20 responders / number of participants treated) * 100. All NR at Week 16, as well as all participants who discontinued study treatment at any time for any reason, were defined as NR starting at that time-point and going forward, including Week 24 endpoint.|Baseline through Week 24|All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1407002|NCT01202760|Secondary|Percentage of Participants Developing Anti-LY2127399 Antibodies|LY2127399 anti-drug antibodies (ADA) were assessed at baseline, 1, 4, 16, and 24 weeks. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)*100. Pts with treatment-emergent ADA were Pts who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or Pts who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Baseline through 24 weeks|All randomized participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
1407003|NCT01202760|Secondary|Population Pharmacokinetics (PK)|Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.|Baseline through 24 weeks|Participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliter per hour (mL/h)||95% Confidence Interval|Mean
1407004|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in immunoglobulin levels. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants who received at least 1 dose of study treatment with evaluable serum immunoglobulin (Ig) data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values.|||grams per liter (g/L)||Standard Error|Least Squares Mean
1407005|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B-cell count is determined by calculating the average of the 2 pretreatment B-cell counts obtained once during Days -28 through -7 and on Day 0. A positive or negative change indicated an increase or decrease, respectively in B-cell count. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants who received at least 1 dose of study treatment with evaluable absolute B-cell data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||cells per microliter||Standard Error|Least Squares Mean
1407030|NCT01202578|Primary|Safety of Tympanostomy Tube (TT) Delivery System|Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.|7 days|Subjects in whom TTDS was attempted.|||percentage of ears|Participants|95% Confidence Interval|Number
1407007|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical health [PCS]). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable SF-36 domain and summary scores. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
1407008|NCT01202760|Secondary|Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response|EULAR Responder index based on 28 joint count categorizes clinical response based on improvement since baseline in DAS28-CRP. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR28 responder is defined as either DAS28-CRP <=5.1 and DAS28-CRP change <-0.6; or DAS28-CRP >5.1 and DAS28-CRP change <-1.2. EULAR28 responder index is defined as good response: DAS28-CRP <=3.2 and DAS28-CRP change <-1.2; moderate response: DAS28-CRP change <-1.2 except cases defined in good response; or DAS28-CRP <=5.1 and DAS28-CRP change <-0.6 and >-1.2. EULAR Remission is defined as a DAS28-CRP score of <2.6.|Up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable EULAR response data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||percentage of participants|||Number
1407009|NCT01202760|Secondary|Probability of an ACR20 Response by 24 Weeks|"ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:~(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7."|Baseline through 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.|||probability of response|||Number
1407010|NCT01202760|Secondary|Time to American College of Rheumatology 20% (ACR20) Response|"ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >= 20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:~(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria – Date of first injection of study treatment + 1) / 7."|Baseline through 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR20 response data. Week 16 non-responders were counted as responders if they responded prior to Week 16. Otherwise, they were censored at the date of the Week 16 injection.|||weeks||95% Confidence Interval|Median
1407011|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable HAQ-DI data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
1407031|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Quality of Life|Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Full Analysis Set; participants with both PASI and DLQI data available. LOCF was used.|||correlation coefficient|||Number
1407065|NCT01202253|Secondary|Percentage of Participants With Prior Colonization With Candida by Species|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1411733|NCT01167829|Secondary|Mean SHGB Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1407012|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and participant global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants, even if participant did not take assigned treatment, did not receive correct treatment, or otherwise did not follow protocol, with evaluable DAS28-CRP data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
1407013|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Physician’s Global Assessment of Disease Activity (Visual Analog Scale)|Physician's assessment of the participant's current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable physician’s global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||millimeters||Standard Error|Least Squares Mean
1407014|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)|Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant’s global assessment of disease activity data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||millimeters||Standard Error|Least Squares Mean
1407015|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)|Participant's assessment of their current arthritis pain using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable participant’s assessment of pain data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||millimeters||Standard Error|Least Squares Mean
1407016|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)|Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable swollen joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||joint count||Standard Error|Least Squares Mean
1407017|NCT01202760|Secondary|Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)|Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.|Baseline, up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable tender joint count data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||joint count||Standard Error|Least Squares Mean
1407032|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and DLQI data available. LOCF was used.|||correlation coefficient|||Number
1407066|NCT01202253|Secondary|Infecting Organisms by Species||Baseline up to Day 14 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
1408018|NCT01195090|Secondary|Body Weight Change|body weight change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||kg||Standard Error|Least Squares Mean
1407018|NCT01202760|Secondary|Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in rheumatoid arthritis that characterizes percentage of improvement in disease activity from baseline based on ACR core set. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater percent improvement). This index was calculated as minimum of a) percentage of improvement in TJ count, b) percentage of improvement in SJ count, or c) third highest percentage of improvement of remaining 5 ACR core criteria: If >=3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment, region, tumor necrosis factor-inadequate responder treatment history, and disease-modifying anti-rheumatic drug (DMARD) background as fixed factors and baseline as a covariate.|Up to 24 weeks|All randomized participants with at least 5/68 tender joints and at least 5/66 swollen joints at baseline and with evaluable ACR-N data. Modified last observation carried forward (mLOCF) was used to impute missing postbaseline values. Data after Week 16 for Week 16 non-responders was not included.|||units on a scale||Standard Error|Least Squares Mean
1407019|NCT01202760|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had >=50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and >=50% improvement in at least 3/5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No) of ACR50 responders/No of Pts treated)*100. ACR70 Responder: had >=70% improvement from baseline in both TJ and SJ counts and >=70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response=(No of ACR70 responders/No of Pts treated)*100. All non-responders at Week 16 as well as all Pts who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.|Up to 24 weeks|All randomized participants with at least 5/68 TJ and 5/66 SJ at baseline and with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included.|||percentage of participants|||Number
1407020|NCT01202760|Primary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had >=20% improvement from baseline in both 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.|Up to 24 weeks|All randomized participants with at least 5/68 tender joints and 5/66 swollen joints at baseline and with evaluable ACR20 data. If participant's CRP was missing, last postbaseline value was used. If ACR was missing after carrying forward CRP, last postbaseline ACR response was used. Data after Week 16 for Week 16 non-responders was not included.|||percentage of participants|||Number
1407021|NCT01202747|Primary|Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)|"Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p<0.05) association between the screening method and outcome.~Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction."|Baseline and 4 Weeks|Results presented are for the Intent to Treat population.|||Correlation coefficient|||Number
1407022|NCT01202656|Secondary|Live Birth Rates|Live birth rates among normal infertile couples undergoing IVF|Within nine months of embryo transfer||||Live Birth|||Number
1407023|NCT01202656|Primary|Embryo Implantation and Clinical Pregnancy Rates|"Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred~Clinical pregnancy:~Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer"|26 to 30 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.|||Gestational sacs|Participants||Number
1407024|NCT01202643|Secondary|Implantation Rate|Number of gestational sacs per number of embryos transferred in each treatment group|28 days after embryo transfer|Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, about 200 embryos transferred in each study arm would be needed for 80% power and alpha of 0.05.|||Gestational sacs|Participants||Number
1407025|NCT01202643|Primary|Endometrial Thickness|Thickness of the endometrium on the day of embryo transfer|Day of embryo transfer||||mm||Standard Deviation|Mean
1407026|NCT01202591|Primary|Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)||3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).|All patients who receive at least one dose of study treatment (AZD4547 or exemestane)|||Participants|||Number
1407027|NCT01202578|Secondary|Tube Retention|Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.|7 days|Tube retention was assessed for all TT successfully placed by the TTDS|||percentage of tubes retained|Participants|95% Confidence Interval|Number
1407028|NCT01202578|Secondary|Proportion of Subjects With Procedure Success|Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.|0 days||||percentage of participants||95% Confidence Interval|Number
1407033|NCT01202565|Secondary|Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis|Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and DLQI data available. LOCF was used.|||correlation coefficient|||Number
1407034|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Scalp Psoriasis Set; participants with both PSSI and PASI data available. LOCF was used.|||correlation coefficient|||Number
1407035|NCT01202565|Secondary|Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis|Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman’s rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.|Baseline and Month 12|Nail Psoriasis Set; participants with both NAPSI and PASI data available. LOCF was used.|||correlation coefficient|||Number
1407036|NCT01202565|Secondary|Change From Baseline in DLQI Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline DLQI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
1407037|NCT01202565|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.|||percent change||Standard Deviation|Mean
1407038|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 50 Response|"The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
1407039|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 75 Response|"The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
1407040|NCT01202565|Secondary|Percentage of Participants Achieving a PASI 90 Response|"The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.~PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease."|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
1409782|NCT01183533|Secondary|Mortality||90 days|Note: although 2 patients were not available for complete day 90 assessments, family/patient communication provided necessary mortality information.|||participants|||Number
1407041|NCT01202565|Secondary|Change From Baseline in PASI Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Full Analysis Set with Baseline PASI score; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
1407042|NCT01202565|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Month 12|Full analysis Set. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) was used.|||percent change||Standard Deviation|Mean
1407043|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Scalp|Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.|Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
1407044|NCT01202565|Secondary|Percentage of Participants Achieving Good Clinical Response on Scalp|"Good clinical response on scalp is defined as a ≥ 50% improvement from Baseline in PSSI score.~The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area."|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
1407045|NCT01202565|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.|Baseline and Months 3, 6, 9, and 12|"Scalp Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
1407046|NCT01202565|Secondary|Percentage of Participants Achieving Complete Clearing of Nails|"Complete clearing of nails is defined as a total NAPSI score of zero.~The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
1407047|NCT01202565|Secondary|Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis|"Good clinical response on nails is defined as ≥ 50% improvement from Baseline in total NAPSI score.~The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants)."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||percentage of participants|||Number
1407063|NCT01202253|Secondary|Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants|||Number
1407048|NCT01202565|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).~A negative change from Baseline indicates improvement."|Baseline and Months 3, 6, 9, and 12|"Nail Psoriasis Set; the analysis was based on all available data. Last observation carried forward (LOCF) was also used for the Month 12 time point. The number of participants included in the analysis at each time point is indicated by N."|||units on a scale||Standard Deviation|Mean
1407049|NCT01202565|Primary|Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12|"The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.~Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Scalp Psoriasis Set (SPS), which includes participants with a Baseline PSSI ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1407050|NCT01202565|Primary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).~Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Month 12|Nail Psoriasis set, which includes participants with a Baseline NAPSI score ≥ 10. Only participants with a Baseline and at least one post-baseline value are included. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1407051|NCT01202279|Primary|Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).|WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.|Baseline and 7 Days||||units on a scale||Standard Deviation|Mean
1407052|NCT01202279|Primary|Antibiotic Sparing|Number of patients who received an antibiotic|Day 7|Per Protocol Population using Fishers Exact Test.|||Participants|||Number
1407053|NCT01202253|Secondary|Number of Participants With Different Types of Drug-related Serious Adverse Events||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
1407054|NCT01202253|Secondary|Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants|||Number
1407055|NCT01202253|Secondary|Number of Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an adverse event (AE) without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||events|||Number
1407056|NCT01202253|Secondary|Duration of Anidulafungin Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||days||Standard Deviation|Mean
1407057|NCT01202253|Secondary|Number of Participants With Other Dosing Patterns|The other dosing patterns for anidulafungin included any dosing pattern different from 200 mg loading dose on Day 1 followed by 100 mg doses subsequently starting from Day 2.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
1407058|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407059|NCT01202253|Secondary|Percentage of Participants Who Received 100 mg Dose on Day 2||Day 2|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407060|NCT01202253|Secondary|Percentage of Participants Who Received 200 mg Loading Dose||Day 1|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407061|NCT01202253|Secondary|Percentage of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407062|NCT01202253|Secondary|Number of Participants Who Received Water-based and Ethanol-based Formulation||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
1409822|NCT01183143|Secondary|Total and Average Daily Dose of GONAL-f®||Up to 26 days|The ITT population included all the subjects who received at least 1 dose of the IMP.|||International Units (IU)||Standard Deviation|Mean
1407067|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan||Baseline|Data was not analyzed as the study was retrospective and data for infection site as per ultrasound and CT scan was not available.||||||
1407068|NCT01202253|Secondary|Number of Participants With Infection Sites as Per Microbiological Analysis|Infection sites included blood, chest, urinary tract, intra-abdominal, bile duct, liver, kidney, mouth and esophagus.|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||participants|||Number
1407069|NCT01202253|Secondary|Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407070|NCT01202253|Secondary|Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407071|NCT01202253|Secondary|Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407072|NCT01202253|Secondary|Dose Changes for Immunosuppressant Drugs||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for dose change for immunosuppressant drugs was not available.||||||
1407073|NCT01202253|Secondary|Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407074|NCT01202253|Secondary|Percentage of Participants With Concomitant Bacterial or Viral Infection|Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407075|NCT01202253|Secondary|Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 and upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100, by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407076|NCT01202253|Secondary|Duration of Stay at Liver Intensive Therapy Unit (LITU)||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Inter-Quartile Range|Mean
1407077|NCT01202253|Secondary|Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)||Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407078|NCT01202253|Secondary|Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy||Baseline up to Day 28 post-treatment|Data was not analyzed as the study was retrospective and data for creatinine clearance was not available for the participants.||||||
1407079|NCT01202253|Secondary|Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy|Percentage of participants with liver function test results at least twice the baseline value during period of drug therapy was calculated for the liver function variables, bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407080|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 IU/L for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407081|NCT01202253|Secondary|Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy|Percentage of participants with abnormal liver function results were based on 4 liver function variables- bilirubin, aspartate transaminase, alkaline phosphatase and gamma glutamyl transferase. Normal reference ranges of these variables are: plasma bilirubin: 3-17 micromoles/L or 2.5-10 mg/L for adults; aspartate transaminase: 6-34 International Units/Liter (IU/L) for females and 8-40 IU/L for males; alkaline phosphatase: 5-38 IU/L for females and 10-50 IU/L for males; gamma glutamyl transferase: 7-32 IU/L for females and 11-50 IU/L for males. Upper limit of confidence interval was reported as 100 if the same was calculated as greater than 100 by standard calculations (outside the valid range of 0 to 100).|Baseline|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407679|NCT01197417|Primary|Hospital Length of Stay (Hours)||From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to outcome|||hours||Inter-Quartile Range|Median
1407082|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results|A CT scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator’s discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407083|NCT01202253|Secondary|Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results|An ultrasound scan was performed and the resultant scan was reviewed for the presence of the infection as per investigator’s discretion.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407084|NCT01202253|Secondary|Percentage of Participants With Documented Eradication of Infecting Species|Documented microbial eradication was defined as 2 negative follow-up blood cultures for bloodstream infections.|Baseline|Data was not analyzed as the study was retrospective and data for eradication of candida infection was not documented in the participants’ medical notes.||||||
1407085|NCT01202253|Secondary|Percentage of Participants With Oral Antifungal Started to Complete Therapy||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407086|NCT01202253|Secondary|Percentage of Participants Requiring Change or Additional Antifungal Therapy|Lower limit of confidence interval was reported as 0 if the same was calculated as less than 0 by standard calculations (outside the valid range of 0 to 100).|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407087|NCT01202253|Secondary|Percentage of Participants With Lack of Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1407088|NCT01202253|Secondary|Percentage of Participants With Favorable Clinical Response|Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1407089|NCT01202253|Secondary|Percentage of Participants With Death Unrelated to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407090|NCT01202253|Secondary|Percentage of Participants With Death Attributable to Fungal Infection||Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants|||Number
1407091|NCT01202253|Secondary|Percentage of Participants Who Died Due to All Causes|Death due to all causes included death attributable to fungal infection, death unrelated to fungal infection and death due to multiple causes.|Baseline up to Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
1407092|NCT01202253|Secondary|Percentage of Participants With Unfavorable Outcome|Unfavorable outcome was defined as the need to change to another antifungal agent because of lack of clinical response or death due to the antifungal infection or microbiologic persistence of the fungus or superinfection with a new Candida, Aspergillus or other fungal strain occurring at least 3 days and up to 14 days of anidulafungin therapy, or a lack of follow up data about clinical and microbiologic responses at the end of anidulafungin therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1407093|NCT01202253|Primary|Percentage of Participants With Favorable Outcome|Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.|Day 28 post-treatment|Full analysis set included all participants who met the defined eligibility criteria. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1407094|NCT01202227|Secondary|Change From Baseline in the Modified Brief Pain Inventory (10 Item) (mBPI-10)Total Scores at Last Evaluation Score|"The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from “does not interfere” (0) to “completely interferes” (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale.~Change = observation mean at Week 52 minus baseline mean."|Baseline, Week 52|"The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available.~The number of participants who had mBPI at Week 52/ Early Termination was 101 participants (n=101)."|||Score on a scale||95% Confidence Interval|Mean
1407095|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Affective Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).|||Score on a scale||95% Confidence Interval|Mean
1407096|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Sensory Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).|||Score on a scale||95% Confidence Interval|Mean
1407097|NCT01202227|Secondary|Change From Baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) at Each Time Point: Total Scores|"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement."|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The full analysis set consists of all participants who received at least one dose of study medication in this long-term study and for whom post-treatment data were available. For study endpoint of efficacy (Week 52), missing values was imputed with the last observation carried forward (LOCF).|||Score on a scale||95% Confidence Interval|Mean
1407098|NCT01202227|Primary|Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)|The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment.|Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407099|NCT01202227|Primary|Number of Participants With Deterioration in Neurological Examination Findings|Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function.|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407100|NCT01202227|Primary|Number of Participants With Visual Field Deteriorated|Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination).|53 weeks|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407101|NCT01202227|Primary|Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407102|NCT01202227|Primary|Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407103|NCT01202227|Primary|Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407104|NCT01202227|Primary|Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407105|NCT01202227|Primary|Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407334|NCT01200069|Primary|Myalgia Reported on Treatment Day 2|Subject self reported numerical rating of incidence and severity of post ECT Myalgia after treatment day 2 0=no pain, 1-3=mild pain (annoying, little interference with ADL), 4-6= moderate,( interferes significantly with ADL) 7-10 severe pain (unable to perform everyday activities)|1 hour, 6 hours, 24 hours & 48 hours following procedure||||units on a scale||Full Range|Median
1407106|NCT01202227|Primary|Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407107|NCT01202227|Primary|Number of Participants With Generalized or Abdominal Edema|Number of participants who had generalized or abdominal edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407108|NCT01202227|Primary|Number of Participants With Facial/Periorbital Edema|Number of participants who had facial or periorbital edema.|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407109|NCT01202227|Primary|Number of Participants With Peripheral Edema|Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema).|Baseline, Weeks 4, 20, 36, 52, and 53|The safety analysis set consists of all participants who received at least one dose of study medication in this long-term study.|||Participants|||Number
1407110|NCT01202188|Secondary|Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization||26 Weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1407111|NCT01202188|Secondary|Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period||26 Weeks|Full Analysis Set includes all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1407112|NCT01202188|Secondary|Rate of Moderate or Severe COPD Exacerbation|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26 Weeks||||Exacerbations per year|||Number
1407113|NCT01202188|Secondary|24 Hour Holter Monitoring in a Subset of Patients|"24-hourly mean heart rate was performed using a Holter Monitor at Weeks 12 and 26 in a subgroup of patients. Mixed model: heart rate = treatment + baseline heart rate + baseline smoking status + baseline ICS use + region + center (region) + error. Center was included as a random effect nested within region.~The 24-hourly mean heart rate is the mean heart rate over the 24 hour period, derived using hourly mean heart rate beats per minute."|Week 12, Week 26|Safety Set Holter Group-a subset of the Safety participants that included all randomized participants who received at least one dose of study drug and participated in the 24 hour Holter monitoring with evaluable data available for analysis. No participants in the Titotropium arm participated in the Holter Monitoring.|||beats per minute||Standard Error|Least Squares Mean
1407114|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12, 23 hours 15 minutes and 23 hours 45 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 23 hours 45 minutes post-dose Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
1407115|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 8, 12 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 12 hours post-dose Day 1 and Week 26|Participants from the 24 hour serial spirometry subset of the full analysis set (all randomized participants who received study drug) with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
1407116|NCT01202188|Secondary|Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|From 5 minutes to 4 hours post-dose Day 1 and Week 26|Participants from full analysis set, all randomized participants who received study drug, with data available for analysis. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from analysis.|||Liters||Standard Error|Least Squares Mean
1407354|NCT01199926|Primary|Muscle Function|The primary endpoint is the change in lean mass (kilograms) after the three month resistance exercise intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.|||kilograms||Standard Deviation|Mean
1407117|NCT01202188|Secondary|"Percentage of Days With no Rescue Medication Use Over 26 Weeks"|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the full analysis set (all randomized participants who received at least one dose of study drug) with evaluable data (at least 40 days of diary data) available for analysis.|||Percentage of days||Standard Error|Least Squares Mean
1407118|NCT01202188|Secondary|Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs in the morning and evening were calculated and divided by the number of days with data to determine the mean daily number of daytime and nighttime puffs. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline (BL) ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.|||Puffs||Standard Error|Least Squares Mean
1407119|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 12, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis at Week 12 and Week 26.|||Puffs per day||Standard Error|Least Squares Mean
1407120|NCT01202188|Secondary|"Percentage of Days Able to Perform Usual Daily Activities Over 26 Weeks"|"Patients answered the question Did your respiratory symptoms stop you performing your usual activities today?-Not at all in their daily diary. The percentage of days is calculated by the number of days patient is able to perform daily activities/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of Days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect."|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.|||Percentage of days||Standard Error|Least Squares Mean
1407121|NCT01202188|Secondary|"Percentage of Days With No Daytime Symptoms Over 26 Weeks"|A day with no day time symptoms is defined from the diary data as any day where the patient recorded no coughing, no wheezing, no sputum production and no breathlessness during the previous 12 hours (approximately 8AM to 8PM). The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent of days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.|||Percentage of days||Standard Error|Least Squares Mean
1407122|NCT01202188|Secondary|"Percentage of Nights With No Night Time Awakenings Over 26 Weeks"|A day with no night time awakenings is defined from the diary data as any day where the patient did not wake up due to COPD symptoms. The percentage of nights is calculated by the number of days with no nighttime awakenings/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline Percent days and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 Weeks|Participants from the Full Analysis Set, all randomized participants who received study drug, with evaluable diary data (at least 40 days) for analysis.|||Percentage of nights||Standard Error|Least Squares Mean
1407123|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status.|Baseline, Week 26|Participants from the Full Analysis Set, that included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Percentage of participants|||Number
1407788|NCT01196104|Secondary|Number of Subjects Reporting Intermittent Coughing Episodes|Number of subjects reporting Intermittent Coughing Episodes|Baseline to Week 16|Safety Population|||Number of participants|||Number
1407124|NCT01202188|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Score on a scale||Standard Error|Least Squares Mean
1407125|NCT01202188|Secondary|Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing) at Week 12 and Week 26. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. The BDI (baseline) was measured at Day 1. The TDI captures changes from baseline. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9.|Baseline, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.|||Percentage of participants|||Number
1407126|NCT01202188|Secondary|Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26|"A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.~A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators as covariates and included baseline smoking status, baseline inhaled corticosteroids and region as fixed effects with center nested within region as a random effect."|Baseline, Week 12, Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Score on a scale||Standard Error|Least Squares Mean
1407127|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Per-protocol Set, randomized participants who received at least one dose of study drug without major protocol deviations. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
1407128|NCT01202188|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
1407129|NCT01202188|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks|The number of puffs of rescue medication taken in the previous 12 hours was record in patient diary in the morning and in the evening for 26 weeks. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient. Rescue medication data recorded during the 14 day run-in was used to calculate the baseline. A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline, Week 26|Participants from the full analysis, consisting of all randomized participant who received study drug, with data available for analysis.|||Puffs per day||Standard Error|Least Squares Mean
1407329|NCT01200160|Primary|Effectiveness of Niaspan|"Increasing serum HDL-C (high-density lipoprotein - cholesterol) levels.~Calculated change in different variables (Difference percent for HDL, LDL, Non-HDL and Triglycerides) was obtained using the expression:~percent.change=((final.visit.variable-baseline.variable.))/(baseline.variable))*100 Then percent change is calculated at 24 weeks regarding baseline for different variables."|24 weeks regarding baseline visit (visit1)||||mg/dL||Standard Deviation|Mean
1413164|NCT01155141|Primary|24 Hour Proteinuria||Baseline - Month 6||||g/day||Standard Deviation|Median
1407130|NCT01202188|Secondary|St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 26|SGRQ is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. A mixed model was used with treatment as a fixed effect with Baseline SGRQ and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|26 weeks|Participants from the Full Analysis Set,included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward but not more than 14 weeks and data within 4 weeks of day 1 were not carried forward.|||Score on a scale||Standard Error|Least Squares Mean
1407131|NCT01202188|Secondary|Transitional Dyspnea Index (TDI) Focal Score at Week 26|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. A mixed model was used with treatment as a fixed effect with Baseline Dyspnea Index Score and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Week 26|Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward.|||Score on a scale||Standard Error|Least Squares Mean
1407132|NCT01202188|Primary|Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values. A mixed model was used with treatment as a fixed effect with baseline FEV1 and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|23 hours 15 minutes and 23 hour 45 minute post-dose Week 26|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis. Data was imputed with last observation carried forward. Data within 6 hours of rescue medication use or 7 days of systemic corticosteroid use is excluded from the analysis.|||Liters||Standard Error|Least Squares Mean
1407133|NCT01202162|Secondary|Quality of Recovery 40|Survey completion at 24 hours post surgery of the Quality of Recovery 40 questionnaire.This questionnaire asks 40 questions in 5 categories of recovery. The scores are combined from each group and are used as a composite score. The scores range from a low of 40 to a high of 200. A score of 40 would indicate a poor quality of recovery where as a score of 200 would be a good quality of recovery at 24 hours postoperative.|1 day|In the Desflurane group 35 completed the survey 24 hours postoperative where as 33 in the Sevoflurane completed the survey during the postoperative period.|||score (between 40 low-200 high)||Inter-Quartile Range|Median
1407134|NCT01202162|Secondary|Number of Participants Who Coughed||Perioperative||||participants|||Number
1407135|NCT01202162|Primary|Time to Awakening||Time inhalational agent is turned off to time of patient awakening||||Elapsed time in minutes||Inter-Quartile Range|Median
1407136|NCT01202110|Primary|Determine in Patients With Traumatic Brain Injury (TBI) the Safe Dosing of Early Propranolol.|The primary outcome is to determine the safety of early propranolol treatment after TBI by recording the number of episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) refractive to treatment.|24 months|Terminated prior to enrolling||||||
1407137|NCT01202071|Secondary|Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])|"Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).~Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)||||ng*h/mL||Standard Deviation|Mean
1407138|NCT01202071|Secondary|Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)|"Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).~Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity."|Day 1 and Day 5 of administration during Period I-IV||||ng/mL||Standard Deviation|Mean
1407139|NCT01202071|Primary|Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration|The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.|Day 5 of administration during Period I-IV||||Percentage of Time in a 24 Hour Period||Standard Deviation|Mean
1407330|NCT01200069|Secondary|Incidence of Headache & Severity Headache After ECT Treatment #3|Subject self reported numerical rating of incidence and severity of post ECT headache after treatment #3, 0=no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9 very serious pain, 10=unbearable pain.|1 hour after treatment, 6 hours, 24 hours and 48 hours||||units on a scale||Full Range|Mean
1415146|NCT01137370|Primary|Prevalence of Vitamin D Deficiency||At enrollment||||participants, %|||Number
1407140|NCT01201967|Secondary|Change in Physical Health-related Quality of Life From Baseline to 24 Weeks|Physical health-related quality of life is measured with the Short Form-12 Physical Component Score (SF-12 PCS). The SF-12 PCS a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.|Baseline, 24 weeks||||units on a scale||95% Confidence Interval|Mean
1407141|NCT01201967|Secondary|Change in Physical Function From Baseline to 24 Weeks|Physical function is measured with the Duke Activity Status Index (DASI). The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
1407142|NCT01201967|Secondary|Change in Health Status From Baseline to 24 Weeks|Health status measured by the Euro Quality of Life-5 Domain (EQ5D). The EQ5D is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
1407143|NCT01201967|Secondary|Number of Rehospitalizations From Baseline to 24 Weeks|The number of rehospitalizations from baseline to 24 weeks was measured by contacting subjects' medical providers at 24 weeks and by asking subjects about rehospitalizations during each follow-up phone call.|24 weeks||||readmissions|||Number
1407144|NCT01201967|Secondary|Change in Adherence to Health Behaviors From Baseline to 24 Weeks|Adherence to health behaviors is measured with the Medical Outcome Study Specific Adherence Scale (MOS-SAS). The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
1407145|NCT01201967|Secondary|Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment|"Adequate treatment was defined as:~(1) Prescription of a standard dose of an established first-line treatment for depression, generalized anxiety disorder, or panic disorder, and/or (2) referral to evidence-based psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborative Care arm of the study).~Patients already engaged in #1 and/or #2 at the time of enrollment had a different process. Subjects must have been engaged in at least 4 weeks of treatment prior to enrollment while still meeting criteria for the disorder. For this population, adequate treatment was defined as:~(1) Prescription dose increase/augmentation/switch, and/or (2) referral to psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborate Care arm).~Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects."|5 days after enrollment|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||participants|||Number
1407146|NCT01201967|Secondary|Change in Anxiety Symptoms From Baseline to 24 Weeks|Anxiety symptoms measured with the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
1407147|NCT01201967|Secondary|Change in Depression Symptoms From Baseline to 24 Weeks|Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
1407148|NCT01201967|Primary|Change in Mental Health-related Quality of Life From Baseline to 24 Weeks|Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.|Baseline, 24 weeks|92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.|||units on a scale||95% Confidence Interval|Mean
1407149|NCT01201915|Secondary|Time to Complete Clinical Clearance|Time to complete clinical clearance was defined as the time from the first treatment with vismodegib until complete clinical clearance as determined by the investigator.|Baseline to the end of the study (up to 12 weeks for Cohort 1; up to 36 weeks for Cohort 2, up to 20 weeks for Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug. Only participants who achieved complete clinical clearance were included in the analysis.|||Days||95% Confidence Interval|Median
1407150|NCT01201915|Primary|Percentage of Participants With Complete Histologic Clearance|Complete histologic clearance was defined as the absence of histological evidence of basal cell carcinoma at the target tumor site. Histological examination was performed by an independent pathologist on specimens collected within 2 weeks of the end of treatment period, ie, at 12 weeks after Baseline in Cohort 1, at 36 weeks after Baseline in Cohort 2, and at 20 weeks after Baseline in Cohort 3.|Baseline to Week 12 (Cohort 1), Baseline to Week 36 (Cohort 2), Baseline to Week 20 (Cohort 3)|Efficacy evaluable population: All participants who were treated with at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1407151|NCT01201811|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1407152|NCT01201811|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|Timeframe: Days 5 and 6 at predose and Day 7 (pre-dose) at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1407153|NCT01201811|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|Timeframe: Day 7 pre-dose at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
1407154|NCT01201811|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
1407155|NCT01201811|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407156|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1407157|NCT01201811|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ was not reported.|Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose|The PK population includes all participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1407158|NCT01201811|Secondary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. Treatment Emergent AEs (TEAE) were defined as AEs with an onset date on or after the first dose of study drug and within 28 days after the date of the last dose. In addition, any AE that occurred beyond this timeframe and that was assessed by the investigator as possibly related to study drug was considered a TEAE."|From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study drug 244 days)|Safety Population included enrolled participants who received at least one dose of investigational product and had at least one postdose assessment|||participants|||Number
1407159|NCT01201811|Secondary|Number of Infections (Post-baseline Average) Requiring Intravenous Antibiotics, Anti-fungals, or Antivirals Per 28 Days|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle. For each participant the overall post-baseline average was calculated as the average of # of infections requiring IV antibiotics or IV antiviral per 28 days per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.|||Infections per cycle||Standard Deviation|Mean
1407160|NCT01201811|Secondary|Number of Platelet Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of platelet transfusions per cycle.|Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population was defined as all enrolled participants.|||Transfusions||Standard Deviation|Mean
1407331|NCT01200069|Secondary|Incidence and Severity of Headache After ECT Treatment 2|Subject self reported numerical rating of incidence and severity of post ECT headache 0=no pain, 2-4=moderate pain, 5-7= distressing severe pain, 8-9= very severe pain, 10=unbearable pain.|1 hour, 6 hour, 24 hour and 48 hours||||units on a scale||Full Range|Mean
1407161|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered platelet transfusion independent at baseline if the participant had no platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) participants who were transfusion independent|||percentage of particpants||95% Confidence Interval|Number
1407162|NCT01201811|Other Pre-specified|Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered platelet transfusion dependent at baseline if the participant had one or more platelet transfusions during the 56 days prior to first dose. During the study, a participant was considered platelet transfusion independent during the on-treatment period if the participant had no platelet transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered platelet transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: platelet dependent at BL=18, platelet independent at BL=26)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The intent-to-treat (ITT) population who were transfusion dependent|||percentage of participants||95% Confidence Interval|Number
1407163|NCT01201811|Secondary|Number of Red Blood Cell (RBC) Transfusions by Cycle|The number of transfusions received 56 days prior to treatment and during study were standardized per 28 days and summarized by cycle for RBCs. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length. For each participant the overall post-baseline average was calculated as the average of # of RBC transfusions per cycle.|Up to week 24;The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|ITT Population- The intent-to-treat (ITT) population was defined as all enrolled participants.|||Transfusions||Standard Deviation|Mean
1407164|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|"A participant was considered RBC transfusion-independent at baseline if the participant had no RBC transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no RBC transfusions during any 56 consecutive days or more (eg, Days 1 through 56, Days 2 through 57, etc.). Otherwise, they were considered transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.|The Intent to Treat (ITT) participants who were transfusion independent|||percentage of participants||95% Confidence Interval|Number
1407165|NCT01201811|Other Pre-specified|Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|"A participant was considered transfusion dependent at baseline if the participant had one or more Red Blood Cell transfusions during the 56 days prior to first dose. During the study, a participant was considered transfusion independent during the on-treatment period if the participant had no transfusions during any 56 consecutive days or more (e.g., Day 1 through 56, Day 2 through 57, etc). Otherwise, they were considered transfusion dependent.~The total N=44, but 1 participant can only be dependent or independent at baseline for each type of transfusion (ie, total = 44: RBC dependent at BL=32, RBC independent at BL=12)"|Baseline to Cycle 6; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit|The intent-to-treat (ITT) participants who were transfusion dependent|||percentage of participants||95% Confidence Interval|Number
1407166|NCT01201811|Primary|Percentage of Participants Showing Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Sponsor|"Hematologic improvements (HI) have 4 categories:~Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor- 10-20g/L increase or ≥50% decrease in transfusion requirements.~Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor-≥50% increase.~Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor-≥100% increase and absolute increase of <0.5x10^9/L~Progression or relapse after HI~Overall hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor’s determination was derived using clinically relevant data.~Denominator for progression/relapse after HI included participants who had achieved HI."|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants|||percentage of participants||95% Confidence Interval|Number
1407175|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Flare Grade at All Time Points|Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
1407332|NCT01200069|Secondary|Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1|Subject self reported numerical rating of incidence and severity of Post ECT pain score for headache at 1, 6, 24 and 48 hours post procedure. Pain Rating 0= no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9=intense very severe pain, 10=unbearable pain|1 hour, 6 hours, 24 hours & 48 hours following procedure||||units on a scale||Full Range|Mean
1407167|NCT01201811|Primary|Percentage of Participants With a Hematologic Response Using International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Investigator|"Hematologic Response according to the 2000 International Working Group (IWG) response criteria for MDS was based on the Investigators determination and defined as:~Complete Response (CR): repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia~Partial Response (PR): same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment~Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months.~Failure: death during treatment or disease progression~Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence~Disease Progression: change in blast levels~Disease Transformation to AML"|Response assessed at end of cycle 6; through week 24; End of study|The intention-to-treat (ITT) population was defined as all enrolled participants|||percentage of participants||95% Confidence Interval|Number
1407168|NCT01201798|Secondary|Change From Baseline (Day 0) in Slit-Lamp Total Sign Score at All Visits|The following signs were each graded on a 0 – 3 scale (0 = absent; 1 = mild; 2 = moderate; 3 = severe): posterior synechia, hypopyon, limbal injection, and keratic precipitates. Peripheral synechia was graded by the combined number of clock hours affected (0 = absent; 1 = < 3 hrs; 2 = 3-6 hours; 3 = > 6 hours). The total sign score was calculated as the sum of the 5 individual sign scores, the anterior chamber cell grade and the anterior chamber flare grade. The minimum/best total sign score was 0, and the maximum/worst total sign score was 23.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
1407169|NCT01201798|Secondary|Change From Baseline (Day 0) in Visual Analog Scale (VAS) Total Symptom Score at All Time Points|The following symptoms were each graded by the subject according to a 0-100 visual analog scale (VAS) using a mark on a 100 mm line (0 = absent, 100 = maximal): eye pain, photophobia, blurred vision, and lacrimation. The total symptom score was calculated as the sum of the 4 individual symptom scores.|Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
1407170|NCT01201798|Secondary|Proportion of Subjects Who Discontinued Due to Lack of Efficacy|Lack of efficacy was defined as those subjects who discontinued study participation either due to treatment failure or an adverse event with a preferred term of iridocyclitis, iritis, uveitis, or vitritis. Proportion is reported as percentage of subjects.|Time to Event|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications.|||Percentage of subjects|||Number
1407171|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade ≤1|As assessed by the investigator during slit lamp examination. Anterior chamber cell grade was graded on a 5-point scale, with 0 = no cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = more than 50 cells. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
1407172|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count ≤5 and Flare Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Anterior chamber flare (protein escaping from dialated vessels) was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
1407173|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Count of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and recorded based on actual cell count. Proportion is reported as a percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
1407174|NCT01201798|Secondary|Proportion of Subjects With Anterior Chamber Cell Grade of 0|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count. Proportion is reported as percentage of subjects.|Day 3, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Percentage of subjects|||Number
1407257|NCT01200589|Secondary|Pharmacokinetics||70 weeks|The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.||||||
1407258|NCT01200589|Secondary|Time to Next Treatment||200 weeks|The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.||||||
1407176|NCT01201798|Secondary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at All Time Points Other Than Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 3, Day 7, Day 21, Day 28, Day 35, Day 42|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
1407177|NCT01201798|Primary|Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14|Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = > 50 cell count.|Baseline (Day 0), Day 14|Per Protocol: All randomized patients who received at least one dose of the allocated study medication and had no major protocol deviations, including violation of entry criteria, poor compliance, and use of prohibited medications. Last observation carried forward (LOCF) was performed for missing data.|||Units on a scale||Standard Deviation|Mean
1407178|NCT01201785|Primary|Collagen Induced Aggregation|Collagen induced aggregation using light transmittance aggregometry|after 1 -week of treatment|A 20% SD for the difference between collagen-induced platelet aggregation in patients on aspirin 81 mg od versus 81 mg bid was assumed, and based on a power of 80% and a significance level of 0.05. Based on these values, we determined that a sample population of 20 patients would be needed.|||percentage of platelet aggregation||Standard Deviation|Mean
1407179|NCT01201772|Primary|PRI Levels at 4 Hours||4 hours after treatment|A total of 65 patients were randomized. One patient assigned to the 10mg prasugrel group was withdrawn after randomization due to anemia identified after baseline blood sampling. Finally, 64 patients [10 mg (n=22), 30 mg (n=21) and 60 mg (n=21)] completed all time periods of the study.|||percentage of platelet reactivity||Standard Error|Mean
1407180|NCT01201759|Secondary|Change in Fasting Values for Vascular Inflammation IL-6 at Visits 2-3 or 4-5|"The pro-atherogenic inflammatory mediators are assessed by the change in fasting values of Interleukin-6 in plasma concentration Pre and Post intervention at -30 min ( fasting).~For fasting values treatments (placebo and salsalate) and visits (pre and post) were defined as within subject’s factors."|Study visit at min -30 (fasting)|All enrolled participants who completed the study.|||mg/dL||Standard Deviation|Mean
1407181|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Lipemia (Free Fatty Acids ) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma Free fatty acids (FFA)sampled before and after intervention at time points of 0min immediately post feeding to 480 min.~For peak FFA area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Each visit sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.|||mg*min/dL||Standard Deviation|Mean
1407182|NCT01201759|Secondary|Change in Area Under the Curve (AUC) for Glycemia (Glucose) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial glycemia is assessed by the change in the AUC for plasma glucose sampled before and after intervention at time points of 0 (immediately post-feeding) to 480 min.~For peak Glucose, and Glucose area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Blood samples for each visit were sampled at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All participants who completed treatment.|||mg*min/dL||Standard Deviation|Mean
1407183|NCT01201759|Primary|Change in Area Under the Curve (AUC) for Lipemia (Triglycerides) at Visits 2-3 or 4-5 Depending on Order of Treatment Assignment.|"The postprandial lipemia is assessed by the change in the AUC for plasma triglycerides sampled before and after intervention at time points 0 (immediately post-feeding)to 480 min.~For peak TG, and TG area under the curve (AUC), treatments (placebo and salsalate) and visits (pre and post treatment) were defined as within-subject’s factors."|Each visit samples at 0 (immediately post-feeding), and 30,60,90,120,240,360,480 min post-feeding..|All enrolled participants who completed the study.|||mg*min/dL||Standard Deviation|Mean
1407184|NCT01201629|Secondary|Discharge Disposition|Patient discharged home or to sub-acute facility|after 4 weeks of intervention||||Participants|||Count of Participants
1407185|NCT01201629|Secondary|Action Research Arm Test (ARAT) Change Scores|The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal|baseline to after 4-weeks of therapy||||units on a scale||Standard Deviation|Mean
1407186|NCT01201629|Primary|Total Functional Independence Measure (TFIM) Change Scores|"The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as complete independence, while a score of one is total assist (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence."|from baseline to 4-weeks of therapy||||units on a scale||Standard Deviation|Mean
1407187|NCT01201486|Primary|Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy|The number of *fetuses with* heart defects detected by color Doppler in the second trimester was compared to the number of *fetuses with* major heart defects detected at birth.|2nd trimester||||fetuses|||Number
1407259|NCT01200589|Secondary|Duration of Response (DOR)||200 weeks|The analysis of this outcome was not performed due to the early termination of the study. Please see the brief summary of the protocol section for additional details.||||||
1407260|NCT01200589|Secondary|Number of Participants With Myelosuppression Adverse Events|The number of participants with myelosuppression adverse events was assessed.|200 weeks|The safety set, comprised of all participants who received one dose of study drug, was analyzed.|||Participants|||Number
1407188|NCT01201343|Secondary|Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24|Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)|Baseline, Months 1, 2, 3, 6, 12, and 24|ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
1407189|NCT01201343|Secondary|Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
1407190|NCT01201343|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
1407191|NCT01201343|Secondary|Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
1407192|NCT01201343|Secondary|Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)|Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
1407193|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 24|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.|||units on a scale||Standard Deviation|Mean
1407194|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 18|ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.|||units on a scale||Standard Deviation|Mean
1407261|NCT01200589|Secondary|Number of Participants With Infusion Related Adverse Events Due to Study Drug|The number of participants with infusion related adverse events due to study drug was assessed.|36 weeks + 60 days|The safety set, comprised of all participants who received one dose of study drug, was analyzed.|||Participants|||Number
1407262|NCT01200589|Secondary|Number of Participants With Infection Related Adverse Events|The number of participants with infection related adverse events was assessed.|200 weeks|The safety set, comprised of all participants who received one dose of study drug, was analyzed.|||Participants|||Number
1407195|NCT01201343|Primary|Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12|EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)|Baseline and Month 12|Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.|||units on a scale||Standard Deviation|Mean
1407196|NCT01201317|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scale (NPSI) Total Score.|Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.|Baseline (Day 1) to Day 29 (Visit 7)|Modified Intention- to- treat set (ITT) including only patients with adequate baseline and Day 29 data|||Scores on a scale||Standard Deviation|Mean
1407197|NCT01201317|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)|||Participants|||Number
1407198|NCT01201317|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥30% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|Intention-to-treat set (ITT)|||Participants|||Number
1407199|NCT01201317|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10, 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)|||Scores on a scale||Standard Deviation|Mean
1407200|NCT01201317|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|Intention-to-treat set (ITT)|||Scores on a scale||Standard Deviation|Mean
1407201|NCT01201265|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.|||mmHg||Standard Deviation|Mean
1407202|NCT01201265|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD).|Baseline, Cycle 6, 12 of treatment|Safety population included all participants who received at least one dose of study treatment. Here, n signifies the number of participants evaluable at specified time points.|||millimetre of mercury (mmHg)||Standard Deviation|Mean
1407203|NCT01201265|Secondary|Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)|The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea & vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms.|Baseline, cycle 6|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment. Here, n signifies the number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1407204|NCT01201265|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 28 days after termination of study treatment (approximately 1569 days)|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
1407205|NCT01201265|Secondary|Overall Survival (OS)|Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||days||95% Confidence Interval|Median
1407206|NCT01201265|Secondary|Time to Progression (TTP)|Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression.|From the date of registration until the disease progression (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||days||95% Confidence Interval|Median
1407263|NCT01200589|Secondary|Number of Deaths|The number of deaths were assessed.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
1407789|NCT01196104|Secondary|Number of Subjects Reporting Cough Episodes|Number of Subjects Reporting Cough Episodes|Baseline to Week 16|Safety Population|||Number of participants|||Number
1418259|NCT01114646|Primary|Mortality|Assessment of post-operative mortality at one-year.|1 year||||pecent|||Number
1407207|NCT01201265|Secondary|Percentage of Participants Achieving a Clinical Benefit Response (CBR)|Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1407208|NCT01201265|Secondary|Percentage of Participants Achieving an Overall Response|The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters.|From the date of registration until the disease progression or death (up to 1541 days)|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1407209|NCT01201265|Primary|Progression-free Survival (PFS)|Progression free survival (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From the date of registration until the disease progression or death (up to 1541 days).|Efficacy analysis population included all participants who received at least one dose of study treatment and with at least one efficacy assessment|||days||95% Confidence Interval|Median
1407210|NCT01200992|Secondary|Comparison of Safety of EN3348 With Mitomycin C [Adverse Events (Other Than Serious Adverse Events) With Frequency Threshold of 5% or Greater].|Safety endpoint displayed includes adverse events (other than serious adverse events) with a frequency threshold of 5% or greater, for each treatment arm. No statistical comparisons have been performed between the 2 treatment arms.|Through study early termination, approximately 23 months from first subject enrolled.|Relevant safety data are presented in the Adverse Events and Serious Adverse Events Modules. Any clinically significant findings pertaining to other secondary outcomes such as vital signs, physical exams and laboratory test results would appear in these Modules as well. No statistical comparisons have been performed between the 2 treatment arms.|||participants|||Number
1407211|NCT01200992|Primary|Comparison of Event-free Survival of Intravesical EN3348 With Mitomycin C.|Primary efficacy endpoint will be event-free survival - the interval from randomization to an event. An event is defined as tumor recurrence, tumor progression to muscle invasive bladder cancer or death, whichever occurs first. Tumor recurrence or progression must be documented by bladder biopsy.|1 year|The study was discontinued early. The number of subjects randomized at time of closure represented 18.7% of the planned enrollment of 450 subjects. Thus, the planned analysis as stated in the protocol was not performed. Only 2 subjects (5.1%) in the EN3348 arm and 4 subjects (8.9%) in the mitomycin C arm completed all planned doses.||||||
1407212|NCT01200875|Primary|Blood Growth Factor Concentrations||5 days following PRP injection||||IGF-1 fold-change from baseline @ 24h||95% Confidence Interval|Mean
1407213|NCT01200810|Secondary|Safety and Tolerability Assessed Using NCI CTCAE Version 4.0|Number of participants randomized to RO4929097 arm who experienced serious adverse events .|Up to 12 months||||participants|||Number
1407214|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Observation Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.||||||
1407215|NCT01200810|Secondary|Time to PSA Progression During the Observation Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.||||||
1407216|NCT01200810|Secondary|Time to PSA Progression During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug.||||||
1407217|NCT01200810|Secondary|Time to PSA Nadir During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug.||||||
1407218|NCT01200810|Secondary|Proportion of Patients With PSA Progression During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.||||||
1407219|NCT01200810|Secondary|Proportion of Patients Who Achieve Complete Response (by PSA) During the Combination Phase||Up to 12 months|Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.||||||
1407220|NCT01200810|Primary|Time to PSA Progression|Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.|Up to 12 months|Data were not collected as the protocol was terminated early due to lack of study drug. Only three patients progressed during randomization phase.||||||
1407790|NCT01196104|Secondary|Mild or Moderate Hypoglycemic Event Rate|"Mild or moderate hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Nonsevere hypoglycemia is defined as a subject:~SMBG levels < 70 mg/dL AND/OR~Symptoms that are relieved by the self-administration of carbohydrates"|Baseline to Week 16|Safety Population|||Events / subject-month|||Number
1407221|NCT01200797|Primary|Time to Progression (TTP)|Estimated probable duration from on‐study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to date of progression (assessed up to 12 months)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.|||days||95% Confidence Interval|Median
1407222|NCT01200797|Primary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details).|On‐study date to date of death from any cause (assessed up to 12 months)|All patients are included in the analysis on intention‐to treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||daya||95% Confidence Interval|Median
1407223|NCT01200797|Primary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of (assessed up to 12 months)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1407224|NCT01200797|Primary|Number of Patients With Each Worst-grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death.|On‐study date to 30 days following final dose of study|Total number of patients reported with any toxicity. Not all participants may have an adverse event, thus not every patient on-treatment may be accounted for in worst-grade toxicities.|||participants|||Number
1407225|NCT01200797|Primary|Overall Response (OR)|Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. Confirmation of CR or PR is required to deem either one the best overall response.|On‐treatment date to date of disease progression (assessed up to 12 months)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is nonevaluable for best overall response|||participants|||Number
1407226|NCT01200758|Secondary|Percentage of Responses Who Showed Rituximab SC Formulation Convenient as Compared to Rituximab IV Formulation as Assessed by Physician/Nurse Opinion|"All investigator physicians and nurses involved in this study were asked to complete question i.e. Which formulation of rituximab (SC or IV) do you think is more convenient? based on their experience with the rituximab SC and IV formulations across all participants and presented as rituximab SC is much more convenient; rituximab SC is a little more convenient; both formulations are equally convenient; rituximab IV is a little more convenient; and rituximab IV is much more convenient."|After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of responses|||Number
1407227|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Responses Showing Time Saved of Staff as Per Physician/Nurse Opinions With Each Administration of Rituximab SC as Compared to Rituximab IV at the End of Cy 8, 15 and 20|All investigator physicians and nurses involved in this study were asked to provide the staff time that could be saved with each administration of rituximab SC as compared with rituximab IV to participants in routine practice afetr Cy 8, 15, 20 and categorized as less than (<) 1 hr, at least 1 hr but <2 hrs, at least 2 hrs but <3 hrs, at least 3 hrs but <4 hrs, >/=4 hrs. Staff were asked not to consider the time needed for the first IV administration. Analysis was done in all participants to show a comparison on the time saved by staffs when administered via SC and IV.|After Cycle 8 of induction treatment (24 weeks) and during the maintenance part of the study after 12 months (i.e., Cycle 15), and after the end of the maintenance treatment, (i.e., Cycle 20) (1 Cycle=4 weeks for Cycle 8 and 8 weeks for Cycles 15 and 20)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of responses|||Number
1407228|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Human Antibodies (HAHAs) to Rituximab|Levels of HAHA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)|"Safety Analysis Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
1407801|NCT01196104|Primary|Change in HbA1c (%) From Baseline to Week 16|Change from Baseline in glycated hemoglobin at Week 16|Baseline to Week 16|Safety Population, participants with data available at Baseline and Week 16|||Percentage of total hemoglobin||Standard Deviation|Least Squares Mean
1407229|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants Positive for Human Anti-Chimeric Antibodies (HACAs) to Rituximab|Levels of HACA in serum were detected at Day 1 of each cycle up to Cycle 8 and at follow-up visit. Stage I and II: Baseline: pre-dose (72 hours prior) D1 of Cy1, Cy 3-20, D0 of Cy2 (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), post-baseline: every 12 weeks after last rituximab administration until 96 weeks (a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II: Baseline, post-baseline (See detailed timeframe in Outcome Measure description)|"Safety Analysis Population: included 6 participants who were randomized under Rituximab SC arm but withdrew after Cy1 and then analyzed under Rituximab IV arm. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
1407230|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase|Depletion is defined as a CD19 value <80 cells/mm^3.|Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
1407231|NCT01200758|Secondary|Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase|Depletion is defined as a cluster of differentiation (CD) 19 value <80 cells per cubic millimeter (cells/mm^3).|Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||percentage of participants|||Number
1407232|NCT01200758|Secondary|Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration||12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])|"Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Participants were analyzed as treated. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||mcg/mL||Full Range|Median
1407233|NCT01200758|Secondary|Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle|Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 [1 Cy=8 weeks]; up to data cutoff of 11 Jan 2016 [up to 6 years])|Stage I and II (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1407234|NCT01200758|Secondary|Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle|Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks & 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 & Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 [up to 32 months])|Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)|"ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here n = number of participants evaluable for this outcome measure at specified timepoint."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1407235|NCT01200758|Secondary|Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab|Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])|Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)|Stage 1 PK Evaluable Population. Here, number of participants analyzed = participants evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1407236|NCT01200758|Secondary|Stage 1: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 [up to 26 months])|Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)|Stage I PK evaluable population. Here, number of participants analyzed = participants evaluable for this outcome measure.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
1407237|NCT01200758|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.|Baseline up to death (up to data cutoff of 11 Jan 2016 [up to 6 years])|ITT population.|||days||95% Confidence Interval|Median
1407238|NCT01200758|Secondary|Percentage of Participants Who Died||Baseline up to death (up to data cutoff of 11 Jan 2016 [up to 6 years])|ITT population.|||percentage of participants|||Number
1407239|NCT01200758|Secondary|Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL|Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT population.|||days||95% Confidence Interval|Median
1410547|NCT01177709|Primary|Weight (wt) in Pounds (Lbs)..|Patients weight in pounds|baseline, 4 weeks, 8 weeks, 12 weeks||||weight(wt) in pounds(lbs)||Standard Error|Mean
1407240|NCT01200758|Secondary|Stage 1 and II (Pooled): Percentage of Participants With Disease Progression/Relapse, New Anti-Lymphoma Treatment or Death Assessed Using International Working Group Response Criteria for NHL|Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT population.|||percentage of participants|||Number
1407241|NCT01200758|Secondary|Stage 1 and II (Pooled): Progression-Free Survival (PFS) Assessed Using International Working Group Response Criteria for NHL|PFS was defined as the time from randomization to disease progression/relapse or death due to any cause. If the specified event (disease progression/relapse, death) did not occur, PFS was censored at the last tumor assessment date showing no disease progression, either during treatment or follow-up. Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. PFS analysis was performed using Kaplan – Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT Population.|||days||95% Confidence Interval|Median
1407242|NCT01200758|Secondary|Stage 1 and II (Pooled): Percentage of Participants With Disease Progression/Relapse or Death|Disease progression: ≥50% increase from nadir in the SPD of any previously identified abnormal node or appearance of any new lesion during or at the end of therapy or ≥50% increase in the greatest diameter of any previously identified node >1 cm in its short axis or in the SPD of more than one node. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 & 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to median of 27 months; up to data cutoff of 11 Jan 2016 [up to 6 years])|Baseline up to disease progression or death up to data cutoff of 11 Jan 2016 (up to 6 years) (See detailed timeframe in Outcome Measure description)|ITT Population.|||percentage of participants|||Number
1407243|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 11 Jan 2016 [up to 6 years]) (1 Cy=8 weeks)|ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1407244|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 11 Jan 2016 [up to 6 years]) (1 Cy=8 weeks)|ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1407245|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1407264|NCT01200589|Secondary|Number of Participants With Overall Response (OR)|The overall response rate (ORR) was defined as the number of participants achieving a CR or partial response (PR). from start of randomization until disease progression, or the start of a new anti-cancer therapy. Disease response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML). Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation. Bone marrow examination to confirm a suspected complete response (CR) was performed within 8 weeks following the onset of a CT scan confirmed CR.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
1407246|NCT01200758|Secondary|Stage II: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage II ITT Population.|||percentage of participants||95% Confidence Interval|Number
1407247|NCT01200758|Secondary|Stage I: Percentage of Participants With Complete Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Complete Response was comprised CR and CRu. A participant was defined as a responder if they sustained a CR or CRu at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage I ITT Population.|||percentage of participants||95% Confidence Interval|Number
1407248|NCT01200758|Secondary|Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised of CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumour response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.|Stage I and II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1407249|NCT01200758|Secondary|Stage I: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for NHL|Overall Response comprised CR, CRu, or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by >75% in the SPD; PR: ≥50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage I: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage I ITT Population included all participants who were randomized in Stage I irrespective whether they received study drug or not.|||percentage of participants||95% Confidence Interval|Number
1407250|NCT01200758|Primary|Stage II: Percentage of Participants With Overall Response at the End of Induction Treatment Assessed Using International Working Group Response Criteria for Non-Hodgkin Lymphoma (NHL)|Overall Response comprised complete response (CR), CR unconfirmed (CRu), or PR. A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and computed tomography (CT) scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by more than (>) 75% in the sum of the products of greatest diameters (SPD); PR: Greater than or equal to (≥) 50% decrease in SPD of 6 largest dominant nodes or nodal masses. The 95% CI was estimated for one sample binomial using Pearson-Clopper.|Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)|Stage II ITT Population included all participants who were randomized in Stage II irrespective whether they received study drug or not.|||percentage of participants||95% Confidence Interval|Number
1407251|NCT01200758|Primary|Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab||Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)|Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1407252|NCT01200602|Secondary|Toxicity Profile|Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1407253|NCT01200602|Secondary|Weight Maintenance Over Time||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1407254|NCT01200602|Secondary|Caloric Intake||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1407255|NCT01200602|Secondary|BMI Trends||4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1407256|NCT01200602|Primary|Proportion of Patients Who Maintain Weight or Experience Weight Gain|A patient will be defined as “success” if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.|4 weeks|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1411734|NCT01167829|Secondary|Maximum Sex Hormone-Binding Globulin (SHGB)Concentration||baseline & day 9||||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1407265|NCT01200589|Secondary|Number of Participants With Complete Response (CR)|Complete response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML) and defined as follows: 1) complete disappearance of all detectable clinical evidence of disease (all target nodes regressing to <=1.5cm in the long axis and all non-target lesions being normal in size by imaging) and disease-related symptoms if present before therapy; 2) the spleen/liver, if considered enlarged due to lymphoma based on CT scan prior to therapy, would be normal and nodules should disappear; and 3) if bone marrow was involved before treatment, the infiltrate must clear on repeat bone marrow biopsy. Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
1407266|NCT01200589|Primary|Progression-free Survival (PFS) - Number of Participants With PFS Events|Disease response assessed by modified 2007 Revised Response Criteria for Malignant Lymphoma. Nodal disease, PD: 1)prev. normal node (<=1.5cm x <=1.0cm) that incr. to >2.0 x ≥1.5cm; 2)≥50% incr. from nadir product of perpendicular diameter (PPD) of any prev. involved node with long axis >1.5cm at baseline (BL) (must incr. by ≥0.5mm & to >2.0cm) OR ≥50% incr. from nadir in long axis of any prev. inv. node with long axis of >1.5cm at BL (long axis must incr. by ≥0.5mm & to >2.0cm); or 3)≥50% incr. from nadir in the sums of prod. of diameters (SPD) of target nodes & ≥1 node with long axis >1.5cm. Extranodal, PD 1)any new lesion >2.0 x ≥1.5cm not attributed to non-lymphoma causes; 2)≥50% incr. from nadir PPD of any targ. les. & >5mm incr. in either axis & les. must measure >1.5cm x ≥1.5cm OR ≥50% incr. from nadir in long axis of any targ. les. & >5mm incr. in either axis & les. must measure >1.5cm x ≥1.5cm; or 3)≥50% incr. from nadir in SPD of targ. nodes & ≥1 node with long axis >1.5cm.|200 weeks|The Intent-to-treat (ITT) analysis set, comprised of all randomized participants, was analyzed.|||Participants|||Number
1407267|NCT01200524|Secondary|Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.|LOCF- Last Observation Carried Forward. At baseline and at end of treatment the participants filled in their Neuropathic Pain Symptom Inventory Scal (NPSI) pain symptom descriptors, recall period 24 hours. Each descriptor was rated on a NUmerical Rating Scale 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Higher total score is considered worse outcome.|Baseline (Day 1) to Day 29 (Visit 7)|mITT analysis set including only those that had adequate NPSI data at baseline and Day 29|||Scores on a scale||Standard Deviation|Mean
1407268|NCT01200524|Secondary|Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.|"Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.~Responder= NRS Average Pain score reduction ≥50% (yes/no)"|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set|||Participants|||Number
1407269|NCT01200524|Secondary|Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.|LOCF- Last Observation Carried Forward. Numerical Rating Scale (NRS) Average Pain score reduction= (change from baseline at Day 28/baseline)*100. Responder=NRS Average Pain score reduction ≥30% (yes/no)|Baseline (mean of Day -5 to Day -1) to Day 28|mITT analysis set|||Participants|||Number
1407270|NCT01200524|Secondary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Worst Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) 0-10; 0=No pain, 10=Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28|||Scores on a scale||Standard Deviation|Mean
1407271|NCT01200524|Primary|Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.|Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.|Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28|mITT analysis set including only those that had adequate NRS data at baseline and Days 24-28|||Scores on a scale||Standard Deviation|Mean
1407272|NCT01200511|Secondary|Patient Reported Outcomes at Month 6|The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit. A subject may have responded with and without.|||units on a scale||Standard Deviation|Mean
1407273|NCT01200511|Primary|Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6|Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.|||percentage of participants|||Number
1407274|NCT01200511|Primary|Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6|VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.|||logMAR||Standard Deviation|Mean
1408019|NCT01195090|Secondary|Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||HOMA-IR score||Standard Error|Least Squares Mean
1433676|NCT00983645|Secondary|Renal Function||6 months post-transplant|Data cannot be located for analysis.||||||
1407275|NCT01200511|Primary|Uncorrected Visual Acuity Across a Range of Distances at Month 6|Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Month 6 from second eye implantation|This analysis population includes all subjects receiving IOL implantation in both eyes with data at visit.|||logMAR||Standard Deviation|Mean
1407276|NCT01200498|Primary|Participants With an Objective Response|Objective response defined as Complete, Partial response, and Clinical Improvement based on International Working Group (IWG) Criteria: Complete remission (CR): Absence transfusion & growth factor support AND Complete resolution disease-related symptoms/signs; Peripheral blood count remission; Normal leukocyte differential; Bone marrow histological remission. Partial remission (PR): All CR except bone marrow histological remission. Clinical improvement (CI): No CR/PR, disease progression with one: ≥2 g/dL increase hemoglobin level or transfusion independent; Either ≥50% reduction in palpable splenomegaly of spleen ≥10 cm baseline or spleen palpable at >5 cm baseline becomes not palpable; ≥100% increase in platelet count & absolute platelet count ≥50,000 x 10^9/L; or ≥100% increase in absolute neutrophil count (ANC) & ANC ≥0.5 x 10^9/L. Progressive disease: Progressive splenomegaly or Leukemic transformation confirmed by bone marrow blast of ≥20%; or Increase peripheral blood blast|Baseline to 3 Cycles (84 days)||||Participants|||Number
1407277|NCT01200433|Secondary|Number of Apneic Episodes.|The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.|during DBS surgery||||number of episodes||Inter-Quartile Range|Median
1407278|NCT01200433|Secondary|Number of Hypertensive Episodes|The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.|During DBS surgery||||number of episodes||Standard Deviation|Mean
1407279|NCT01200433|Secondary|Cerebral Perfusion Pressure||at the first peak during DBS surgery||||mmHg||Inter-Quartile Range|Median
1407280|NCT01200433|Secondary|Pulsatility Index|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.|at the first peak during DBS surgery||||units on a scale||Inter-Quartile Range|Median
1407281|NCT01200433|Secondary|Alertness/Sedation|Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)|at the first peak during DBS surgery||||units on a scale||Inter-Quartile Range|Median
1407282|NCT01200433|Secondary|Cerebral Blood Flow|The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.|after procedure, in post anesthesia care unit (PACU)|The cerebral flow at PACU was not planned as a primary outcome. The primary outcome was cerebral flow at the first peak of study drug. The data was collect for information purpose only. No test was done for cerebral blood flow at PACU.|||cm/sec||Standard Deviation|Mean
1407283|NCT01200433|Primary|Brain Oxygen|Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.|during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods||||% oxygenation||Inter-Quartile Range|Median
1407284|NCT01200433|Primary|Cerebral Blood Flow|Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.|For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.||||cm/sec||Inter-Quartile Range|Median
1407285|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
1407286|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
1407287|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)|Systemic events (any fever >= 37.5 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
1407308|NCT01200355|Primary|Time to Failure|Clinical failure is defined as: 1) need for systemic antifungal therapy (AmBisome) for > 3 consecutive days for presumptive fungal infection, toxicity or intolerance of study medication or 2) death.|2 years|Analysis based on a modified intention-to-treat (mITT) approach, with the use of data from patients who underwent randomization and received 2 or more doses of prophylaxis. Trial designed w/ power to detect absolute differences of ~25% of prophylaxis failure in the two groups with ~ 80% power and a significance level of 5% using a two-tail test.|||Days||Inter-Quartile Range|Median
1407288|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)|Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any systemic reaction. 'n'=participants reporting yes for at least 1 day or no for all days for specified systemic reaction for each group, respectively.|||percentage of participants|||Number
1407289|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1407290|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1407291|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1407292|NCT01200368|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction. 'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1407293|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.|||EU/mL||95% Confidence Interval|Geometric Mean
1407294|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.|||IU/mL||95% Confidence Interval|Geometric Mean
1407295|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series|GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all expected doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.|||EU/mL||95% Confidence Interval|Geometric Mean
1407296|NCT01200368|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series|GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result for the proposed analysis, and had no major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
1407297|NCT01200368|Secondary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose|Predefined antibody level was 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.|1 month after the toddler dose|Evaluable toddler immunogenicity population. N (number of participants analyzed) = number of participants with determinate DTaP antibody level to serotype.|||percentage of participants||95% Confidence Interval|Number
1407326|NCT01200160|Secondary|Overall Safety and Tolerability of Niaspan|Evaluate overall safety of Niaspan through evaluation of adverse events|every 4 weeks for 24 weeks|||||||
1407298|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1407299|NCT01200368|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the toddler dose|Evaluable toddler immunogenicity set:eligible participants who received vaccine to which they were randomized at all 4 doses,had blood drawn within specified time,had >=1 valid assay result after toddler dose for analysis,had no major protocol violation.N(number of participants analyzed)=participants with determinate IgG antibody level to serotype.|||percentage of participants||95% Confidence Interval|Number
1407300|NCT01200368|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series|Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1407301|NCT01200368|Primary|Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series|Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1407302|NCT01200368|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1407303|NCT01200368|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.|1 month after the infant series|Evaluable infant immunogenicity population: eligible participants who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid and determinate assay result after Dose 3 for the proposed analysis, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1407304|NCT01200355|Secondary|To Compare Overall Survival Rates at 6 Weeks||6 weeks from randomization between the two treatment arms.||||Participants|||Count of Participants
1407305|NCT01200355|Secondary|Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.||2 years||||Participants|||Count of Participants
1407306|NCT01200355|Secondary|To Compare the Incidence of Possible, Probable or Proven Invasive Fungal Infections Between Patients Who Receive Posaconazole and Those Who Receive Micafungin During Treatment Phase||2 years||||Participants|||Count of Participants
1407307|NCT01200355|Secondary|To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin.||2 years|Results reflect patients who discontinued prophylaxis for suspected IFI (invasive fungal infection)|||days||Inter-Quartile Range|Median
1407327|NCT01200160|Secondary|Frequency of Flushing Events|evaluate occurrence of such events over time|every 4 weeks for 24 weeks|||||||
1411735|NCT01167829|Secondary|Mean Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1407309|NCT01200342|Primary|Number of Participants With Response|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions.|||Participants|||Number
1407310|NCT01200342|Primary|Overall Response Rate (Percentage Subjects With Confirmed Complete or Partial Response)|Tumor response by Response Evaluation Criteria in Solid Tumors for participants with measurable disease defined by presence of at least 1 measurable lesion at baseline: Complete Response (CR): disappearance all target lesions determined by 2 consecutive observations not less than 4 weeks apart. Partial Response (PR): >30% decrease in sum of LD of target lesions (LD) of target lesions taking as reference baseline sum LD determined by two consecutive observations not less than four weeks apart. Progression (PD): >20% increase in sum of LD of target lesions references smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking references smallest sum LD since treatment started. Measurable: lesions accurately measured in at least 1 dimension (longest diameter to be recorded) as 20 mm with conventional techniques or as 10 mm with spiral CT s|Following two 3-week cycles|The efficacy-evaluable population defined as all subjects who completed at least two cycles of therapy and had at least one post-screening assessment of target and non-target lesions. Due to inadequate enrollment of study participants, no statistical analyses were able to be performed.|||Percentage of Participants|||Number
1407311|NCT01200290|Primary|Number of Participants With a Change From Baseline Positive to Post-Baseline Negative in the Summation of Top 10 Highest Antibody Levels (Class I and Class II Single Antigen Reactivity Reported Separately) During Treatment and Follow-Up||Baseline through Weeks 24, 52 and 76|All enrolled participants who received at least 1 dose of study drug and had single antigen reactivity assessed at baseline, during treatment and during follow-up.|||Participants|||Count of Participants
1407312|NCT01200290|Secondary|Population Pharmacokinetics (PK): Constant Clearance|Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.|Baseline through Week 24|All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliters/hour (mL/h)||Standard Error|Mean
1407313|NCT01200290|Secondary|Percent Change From Baseline in Absolute Counts of B Cell Populations in Peripheral Blood|B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).|Baseline, Weeks1, 4, 8, 16, 24, 36 and 52|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.|||percent change in absolute counts||Standard Deviation|Mean
1407314|NCT01200290|Secondary|Percent Change From Baseline in Relative Percent of Lymphocytes for B Cell Populations in Peripheral Blood|B cell population counts are: Total B cells (CD19+), mature naïve B cells (CD19+CD27-IgD+CD10-), switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), Tr B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).|Baseline, Weeks1, 4, 8, 16, 24, 36, 52, 64 and 76|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline peripheral blood B cell populations value and at least 1 non-missing post-baseline B cell populations value.|||relative percent of Lymphocytes||Standard Deviation|Mean
1407315|NCT01200290|Secondary|Percent Change From Baseline at Week 1 and Week 24 in Relative Percent of Lymphocytes for B Cell Populations in the Tonsil|B cell population counts are: Total B cells [cluster designation (CD)19+], mature naïve B cells [CD19+CD27-immunoglobulin D (IgD)+CD10-], switched memory B cells (CD19+CD27+IgD-), unswitched memory B cells (CD19+CD27+IgD+), germinal center B cells Bm2&apos (CD19+CD38+IgD+), germinal center B cells Bm3, Bm4 (CD19+CD38+IgD-), germinal center B cells (CD19+CD38+CD10+CD71+), transitional (Tr) B cells (CD19+CD38++/+++CD24+++/+CD10+) and Tr B cells (CD19+CD27-IgD+CD10+).|Baseline, Weeks 1 and 24|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline tonsil B cell populations value and at least 1 non-missing post-baseline B cell populations value.|||relative percent of Lymphocytes||Standard Deviation|Mean
1407316|NCT01200290|Secondary|Change From Baseline in Serum Immunoglobulin Levels|Immunoglobulins (Ig), or antibodies, are large molecular weight proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline in serum immunoglobulin A (IgA), immunoglobulin G (IgG), IgG1-4, and immunoglobulin M (IgM) levels are reported. A negative change indicates a decrease in Ig levels.|Baseline, Weeks 8, 16, 24, 36 and 52|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline Ig value and at least 1 non-missing post-baseline Ig value.|||grams/liter (g/L)||Standard Deviation|Mean
1407328|NCT01200160|Secondary|Evaluate Changes Induced by Niaspan at the Completion of the Study Against Base Line Values|Evaluation of changes in non-HDL-C (non-high-density lipoproteins-cholesterol) lipids, LDL- C (low-density lipoproteins-cholesterol), total cholesterol and triglycerides (including in subjects with high triglycerides ≥ 200 mg/dL), and the impact on the Framingham score|every 4 to 8 weeks for 24 weeks|||||||
1407333|NCT01200069|Primary|Myalgia Reported After Treatment #3|Subject self reported severity of myalgia based on a self reported assessment utilizing numeric rating scale 0=no myalgia, 1-3=mild myalgia (annoying, little interference with ADL);4-6=moderate (interferes significantly with ADL); 7-10 severe myalgia(unable to perform every day activities)|1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment||||units on a scale||Full Range|Median
1407317|NCT01200290|Primary|Change From Baseline in Arcsine Transformed PRA Scores|The PRA value is calculated and expressed as a percentage, which can range from 0% to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population. PRA scores were transformed using the arcsine function, which enables a skewed distribution of data typically expressed as proportions to achieve properties closer to a normal distribution. The range of possible arcsine transformed PRA scores is 0 (when PRA = 0) to approximately 1.57 (when PRA =100). Higher scores indicate the participant has antibodies against HLA antigens that appear frequently in the organ donor population.|Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.|||units on a scale||Standard Deviation|Mean
1407318|NCT01200290|Primary|Change From Baseline in PRA|The PRA value is calculated and expressed as a percentage, which can range from 0 % to 100%. The value represents a summation of the total HLA antibody burden that the participant has and how frequently those HLA antigens appear in organ donor population. A calculated PRA of 20% means the participant has antibodies that represent an antigen frequency that exists in approximately 20% of the population.|Baseline, Weeks 8, 16, 24, 36, 52, 64 and 76|All enrolled participants who received at least 1 dose of study drug, had a non-missing baseline PRA score and at least 1 non-missing post-baseline PRA score.|||percentage of population||Standard Deviation|Mean
1407319|NCT01200238|Secondary|Grade 3-4 Treatment-Related Toxicity Rate|All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.|AE assessment was ongoing from the start of study drug and up to day 30 post-treatment. Mean treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)). Thus, AEs on treatment were followed up to 31.7 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
1407320|NCT01200238|Secondary|Overall Survival (OS)|OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive.|Survival follow-up occurred every 4 weeks long-term; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months).Thus, follow-up was up to 36.4m.|The analysis dataset is comprised of all enrolled participants.|||months||90% Confidence Interval|Median
1407321|NCT01200238|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not experience progression were censored at date of last disease evaluation.|Dz was evaluated every 8 weeks on treatment; Imaging was obtained as clinically indicated until off-study; Median (range) on-study duration (months) was cohort A: 8.7 (3.7 to 28.7) and cohort B: 4.5 (1.2 to 36.4 months). Thus, follow-up was up to 36.4m.|The analysis dataset is comprised of all enrolled participants.|||months||90% Confidence Interval|Median
1407322|NCT01200238|Secondary|Disease Control Rate (DCR)|DCR is defined as achieving stable disease (SD), partial response (P R) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. PR or better response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)].Thus, response on treatment was evaluated up to 31.7 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
1407323|NCT01200238|Secondary|Objective Response Rate (ORR)|ORR is defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status required confirmation no earlier than 4 weeks following first documentation. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Median treatment duration was 1.8 months for each cohort [range: cohort A (0.9-12.5), cohort B (0.8-31.7)]. Thus, response on treatment was evaluated up to 31.7 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
1407324|NCT01200238|Primary|Expression of cMET|To estimate the proportion of patients with greater than 50% decrease in expression of HSP90 client protein c-MET 18-24 hours after administration of STA-9090|Estimated up to 24 hours after administration of STA-9090|There was a problem with the assay and therefore this endpoint was not measured.||||||
1407325|NCT01200238|Primary|4-month Progression Free Survival (PFS) Rate|4-month PFS rate was defined as the proportion of participants alive, absent progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) and on treatment at 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Relevant for this endpoint was status at 4 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||90% Confidence Interval|Number
1407335|NCT01200069|Primary|Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1|subject self reporting rating scale for severity of myalgias utilizing numeric rating scale 0= no pain, 1-3= mild pain, annoyance with little interference with Activities of Daily Living (ADL), 4-6= moderate (interferes significantly with ADL, 7-10 = severe pain unable to perform ADL|Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours|subjects report at one hour following treatment|||units on a scale||Full Range|Median
1407336|NCT01199965|Primary|AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg*h/ml||Standard Deviation|Geometric Mean
1407337|NCT01199965|Primary|Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Geometric Mean
1407338|NCT01199939|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) and Cluster of Differentiation 8 (CD8+) Cell Counts at Week 48||Baseline (Day 1) and Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications|||cells/uL||Standard Deviation|Mean
1407339|NCT01199939|Secondary|Number of Participants With Virologic Failure|Virologic Failure is defined as participant who is a rebounder or a non-responder. Rebounder participant is defined as a participant who is still in the study at Week 12 and first achieves 2 consecutive virologic responses (<50 copies/mL) followed by 2 consecutive non-responses or a discontinued participant (any reason) for which the last observed time point shows a non-response. Non responder participant is defined as a participant who is still in the study at Week 12 and never achieves 2 consecutive responses.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications|||Participants|||Number
1407340|NCT01199939|Secondary|Time to Reach First Confirmed Virologic Response|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus – type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Baseline (Day 1) to Week 48|Intent-To-Treat participants enrolled in the study who took at least one dose of any of the study medications|||Days||Standard Error|Mean
1407341|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 48||Baseline (Day 1) and Week 48|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 48|||log10 Copies/mL||Full Range|Median
1407342|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 42||Baseline (Day 1) and Week 42|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 42|||log10 Copies/mL||Full Range|Median
1407343|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 36||Baseline (Day 1) and Week 36|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 36|||log10 Copies/mL||Full Range|Median
1407344|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 30||Baseline (Day 1) and Week 30|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 30|||log10 Copies/mL||Full Range|Median
1407345|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 24||Baseline (Day 1) and Week 24|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 24|||log10 Copies/mL||Full Range|Median
1407346|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 20||Baseline (Day 1) and Week 20|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 20|||log10 Copies/mL||Full Range|Median
1407347|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 16||Baseline (Day 1) and Week 16|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 16|||log10 Copies/mL||Full Range|Median
1407348|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 12||Baseline (Day 1) and Week 12|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 12|||log10 Copies/mL||Full Range|Median
1407349|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 8||Baseline (Day 1) and Week 8|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 8|||log10 Copies/mL||Full Range|Median
1407350|NCT01199939|Secondary|Change From Baseline in Log10 Plasma Human Immunodeficiency Virus – Type 1 (HIV-1) Viral Load at Week 4||Baseline (Day 1) and Week 4|Intent-to-treat participants who received at least one dose of any of the study medication with evaluable data at Week 4|||log10 Copies/mL||Full Range|Median
1407351|NCT01199939|Primary|Number of Participants With Confirmed Virologic Response (CVR) at Week 48|CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus – type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.|Week 48|Intent-To-Treat Non-Virologic failure (VF) censored: Participants who took at least one dose of any of the study medications and did not withdraw for reasons other than VF or experienced VF prior to discontinuation. Participants with evaluable data at Week 48|||Participants|||Number
1407352|NCT01199926|Primary|Inflammation|The primary endpoint is the change in C reactive protein after the three month intervention|three months||||mg/L||Standard Deviation|Mean
1407353|NCT01199926|Primary|Glucose Tolerance|The primary endpoint is the change in the area under the glucose curve following an oral glucose tolerance test prior to and after the three month intervention.|three months|Power statistical calculation was completed based on 80% power and error on lean mass measurement.|||mmol/L/120 min||Standard Deviation|Mean
1407355|NCT01199861|Secondary|Number of Participants With Adverse Events (AEs)|"Relationship to study drug was determined by the investigator (suspected/not suspected).~A serious AE is defined as an event which fulfills one of the following criteria:~is fatal or life-threatening;~results in persistent or significant disability/incapacity;~constitutes a congenital anomaly/birth defect;~requires inpatient hospitalization or prolongation of existing hospitalization;~is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above."|From first dose of study drug until 45 days after the last dose of study drug (130 days).|Safety set - all patients who received at least 1 dose of study drug.|||participants|||Number
1407356|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).|Full analysis set for whom data were available.|||ratio|||Number
1407357|NCT01199861|Secondary|Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination|Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.|Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).|Full analysis set for whom data were available.|||ratio|||Number
1407358|NCT01199861|Secondary|Immune Response 6 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:~Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.~Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)|Full analysis set for whom data were available.|||percentage of participants|||Number
1407359|NCT01199861|Secondary|Immune Response 3 Weeks After Tetanus Toxoid Booster|"Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:~Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.~Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)|Full analysis set for whom data were available.|||percentage of participants|||Number
1407360|NCT01199861|Secondary|Immune Response 6 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:~Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.~Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).|Full analysis set for whom data were available.|||percentage of participants|||Number
1407361|NCT01199861|Primary|Immune Response 3 Weeks After Seasonal Influenza Vaccination|"Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:~Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.~Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold."|Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)|The full analysis set which includes all patients who were randomized and received at least 1 dose of study drug, and for whom data were available.|||percentage of participants|||Number
1407362|NCT01199822|Secondary|Number of Participants With Treatment Related AEs|Data presented are the number of participants who experienced a treatment related AE of any grade.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1407363|NCT01199822|Secondary|Number of Participants With Serum Anti-Olaratumab Antibody Assessment (Immunogenicity)|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|First dose to study completion up to 5.6 months|All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.|||participants|||Number
1407364|NCT01199822|Secondary|Volume of Distribution at Steady State (Vss)||Cycle 2: Pre-dose and up to 336 hours post-dose|Zero participants were analyzed because of insufficient amount of samples collected.||||||
1407365|NCT01199822|Secondary|Clearance of Olaratumab at Steady State (CLss)|CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.|Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate CLss. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to limited data, CLss is not representative of the study population.|||milliliters/hour/kilogram (mL/h/kg)||Geometric Coefficient of Variation|Geometric Mean
1408020|NCT01195090|Secondary|Changes in High Sensitive C-reactive Protein|fasting high sensitive serum C-reactive protein change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||mg/dl||Standard Error|Least Squares Mean
1407366|NCT01199822|Secondary|Terminal Elimination Half-Life (t1/2) of Olaratumab|t1/2 is the time it takes for the drug concentration in serum to decrease to half the value observed at the beginning of the time period.|Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate t1/2. Due to limited data and the relatively short duration of sample collection, t1/2 is not representative of the study population.|||days||Full Range|Geometric Mean
1407367|NCT01199822|Secondary|Area Under the Concentration of Olaratumab Versus Time Curve During One Dosing Interval (AUCτ) Following Multiple Doses||Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had PK data available to calculate AUCτ. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to the limited data, AUCτ is not representative of the study population.|||micrograms*hours/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1407368|NCT01199822|Primary|Maximum Concentration (Cmax) of Olaratumab Following Multiple Doses||Cycle 2: Pre-dose and up to 336 hours post-dose|All participants who received study drug and had pharmacokinetic (PK) data available to calculate Cmax. Due to the limited data, Cmax is not representative of the study population.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1407369|NCT01199822|Primary|Number of Participants With a Dose- Limiting Toxicity (DLT) in Cycle 1|A DLT is defined as 1 of the following events, if considered by the investigator to be definitely, probably, or possibly related to olaratumab: NCI-CTCAE v4.02 Grade 4 neutropenia lasting >7 days; NCI-CTCAE v4.02 Grade ≥3 thrombocytopenia with signs of bleeding or requiring platelet transfusions; NCI-CTCAE v4.02 Grade ≥3 neutropenia associated with fever; NCI-CTCAE v4.02 Grade 3 or 4 nonhematologic toxicity, excluding electrolyte abnormality; NCI-CTCAE v4.02 Grade ≥3 skin toxicity despite best preemptive and supportive care; and/or NCI-CTCAE v4.02 Grade ≥3 diarrhea, nausea, or vomiting despite best preemptive and supportive care.|First dose through Cycle 1 (6 weeks/cycle)|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1407370|NCT01199822|Primary|Number of Participants With SAEs|A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1407371|NCT01199822|Primary|Number of Participants With Adverse Events (AEs)|Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 as determined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.02. A summary of serious adverse events (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to study completion up to 5.6 months|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
1407372|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications|Concomitant medications are defined as drugs used during the administration of Relenza.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407373|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407374|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories|Participants with only hypertension were excluded from the cardiocirculatory disease category. Participants in high-risk categories are at risk for the aggravation of both infection and symptoms.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407375|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Risk Factors for Influenza or Having no Risk Factors|Risk factors are defined as pregnancy; infancy; being elderly; and having chronic respiratory disease, cardiocirculatory disease, and/or diabetes.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407376|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications|A complication is defined as asthma.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407377|NCT01199744|Secondary|Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza|The dose given for treatment of influenza is 10 mg twice daily for 5days. Prophylaxis is defined as a measure taken for the prevention of a disease or condition. The prophylactic dose of Relenza is 10 mg once daily for 10 days.|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407378|NCT01199744|Secondary|Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407379|NCT01199744|Secondary|Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction||5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1410444|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1407380|NCT01199744|Secondary|Number of Participants With Any Serious Adverse Drug Reaction (ADR)|"A serious ADR is defined as a serious adverse drug event (ADE) that a physician has determined to be related to the use of Relenza. Serious ADE: death caused by an ADR; an event that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in severe symptoms requiring treatment so that symptoms do not lead to previously mentioned outcomes, and a congenital anomaly/birth defect. For a complete list of all serious ADRs recorded during the study, see Serious Adverse Events section."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407381|NCT01199744|Primary|Number of Participants With Any Adverse Drug Reaction|"An adverse drug reaction is defined as a drug adverse event that a physician has determined to be related to the use of Relenza. A drug adverse event is defined as any unfavorable or unintended sign (including laboratory test abnormalities), symptom, or disease that occurs when a drug is administered, regardless of the relationship to the drug. For a complete list of all adverse drug reactions recorded during the study, see the section entitled Other (Non-serious) Adverse Events."|5 months (November 2009 to March 2010)|All participants who visited the sentinel 26 centers from the date of the contract to 31st March 2010 and were prescribed Relenza for the purpose of either treatment or prophylaxis of influenza|||participants|||Number
1407382|NCT01199731|Secondary|Number of Participants With Electrocardiograph (ECG) With Values of Potential Critical Concern (PCI)|Number of participants with ECG of PCI above 480 has been presented. ECG was be performed twice on Day 1 at least 5 minutes apart and following 5 minutes of rest in a semi supine position at ∼1 hour prior to first dose. ECG evaluations at other visits was obtained after dosing, preferably at 2 hours post dosing. An ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals was used.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
1407383|NCT01199731|Secondary|Number of Participants Who Discontinued Treatment Due to AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
1407384|NCT01199731|Secondary|Change From Baseline in CD4+ Cell Counts After Switch of GSK2248761|CD4 is a receptor for the HIV virus. Most of the damage to an AIDS patient's immune system is done by the virus' destruction of CD4+ lymphocytes. Change from Baseline was calculated as (observed value - Baseline value). Baseline was Day 1 value.|Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and Follow-up Week 4, 8, 12|ITT-E. Only those participants available at the specified time points were analyzed.|||Cells/mm^3||Standard Deviation|Mean
1407385|NCT01199731|Secondary|Change From Baseline in CD4+ Cell Counts Prior to Switch of GSK2248761|CD4 is a receptor for the HIV virus. Most of the damage to an AIDS patient's immune system is done by the virus' destruction of CD4+ lymphocytes. Change from Baseline was calculated as (observed value - Baseline value). Baseline was Day 1 value.|Baseline (Day 1) and Week 2, 4, 8, 12 and 16|ITT-E. Only those participants available at the specified time points were analyzed.|||Cells/mm^3||Standard Deviation|Mean
1407386|NCT01199731|Secondary|Absolute Values of CD4+ Cell Counts After Switch of GSK2248761|CD4 is a receptor for the HIV virus. Most of the damage to an AIDS participant's immune system was done by the virus' destruction of CD4+ lymphocytes. Absolute values of CD4+ cell counts after Switch of GSK2248761 has been presented.|Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and Follow-up Week 4, 8, 12|ITT-E. Only those participants with data available at the specified time points were analyzed.|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
1407387|NCT01199731|Secondary|Number of Participants Who Experienced Disease Progression (HIV-associated Conditions, AIDS and Death)|Clinical DP was defined as progression from Baseline HIV disease status:Category A at Baseline to Centers for Disease Control and Prevention(CDC) category B event, category A at Baseline to CDC category C event, category B at Baseline to CDC category C event, category C at Baseline to new CDC category C event or category A, B or C at Baseline to death. Category A consisted of one or more of the conditions like asymptomatic HIV infection, persistent generalized lymphadenopathy and acute (primary) HIV infection with accompanying illness in an adolescent or adult(>13 years) with documented HIV infection. Category B consisted like Bacillary angiomatosis, Candidiasis, oropharyngeal (thrush), Candidiasis, vulvovaginal; persistent, frequent, oral, Herpes zoster etc. Category C included clinical conditions listed like Candidiasis of bronchi, trachea, or lungs, Candidiasis, esophageal, Cervical cancer, Coccidioidomycosis, disseminated or extrapulmonary etc in AIDS surveillance case definition.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|ITT-E population.|||Participants|||Count of Participants
1407388|NCT01199731|Secondary|Change From Baseline in Plasma HIV-1 RNA After Switch of GSK2248761|A switch was defined as any ART substitution or addition in the participant's ART regimen. Any ART switch permitted per protocol that was determined necessary and documented prior to the first on-treatment visit where HIV-1 RNA was assessed could occur without penalty. However, any participants with an ART switch not permitted per protocol or ART switch permitted per protocol with a viral load >=50 copies/mL at the time of the decision to switch was made was counted as a non-responder from that point onward for all assessment windows without a viral load measurement collected prior to the switch. Change from Baseline was calculated as (observed value - Baseline value ). Baseline was Day 1.|Baseline (Day 1) and post switch Week 1, 2, 4, withdrawal and follow-up Week 4, 8, 12|ITT-E. Only those participants available at the specified time points were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1407409|NCT01199471|Secondary|Time to Eye Opening of Patients|Time to eye opening of patients was measured by the time from cessation of anesthesia administration to opening of the patients' eyes. After cessation of anesthesia, the investigators lightly tapped on the patients forehead or shoulder and asked the patients to open their eyes. This process was repeated about every minute until the patients opened their eyes.|Every minute after cessation of anesthesia until the patient opened his/her eyes|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
1407389|NCT01199731|Secondary|Change From Baseline in Plasma HIV-1 RNA Prior to Switch of GSK2248761|A switch was defined as any ART substitution or addition in the participant's ART regimen. Any ART switch permitted per protocol that was determined necessary and documented prior to the first on-treatment visit where HIV-1 RNA was assessed could occur without penalty. However, any participants with an ART switch not permitted per protocol or ART switch permitted per protocol with a viral load >=50 copies/mL at the time of the decision to switch was made was counted as a non-responder from that point onward for all assessment windows without a viral load measurement collected prior to the switch. Change from Baseline was calculated as (observed value - Baseline value). Baseline was Day 1. The unit is log10 copies per milliliter (log10 copies/mL).|Baseline (Day 1) and Week 2, 4, 8, 12 and 16|ITT-E population. Only those participants available at the specified time points were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
1407390|NCT01199731|Secondary|Number of Participants With Abnormal Hematology Laboratory Data With Grade 3 or 4 TE Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of IP). The hematology parameters included hemoglobin, total neutrophils, and white blood cells (WBC) count. Categories with values has been presented. Grade 3=severe and Grade 4=potentially life threatening. No toxicity-related dose reductions of IP was allowed. IP and background ART was restarted as soon as medically appropriate; in general, this was no longer than 14] days after discontinuation (unless Grade 3 or 4 toxicities persisted).|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
1407391|NCT01199731|Secondary|Number of Participants With Abnormal Clinical Chemistry Laboratory Data With Grade 3 or 4 Treatment-Emergent (TE) Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of IP). Division of acquired immunodeficiency syndrome (AIDS) toxicity scale for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0 was used for grading i.e. Grade 3=severe and Grade 4=potentially life threatening. Categories with values have been presented. No toxicity-related dose reductions of IP was allowed. IP and background antiretroviral therapy (ART) was restarted as soon as medically appropriate; in general, this was no longer than 14] days after discontinuation (unless Grade 3 or 4 toxicities persisted).|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population.|||Participants|||Count of Participants
1407392|NCT01199731|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up i.e. 2-4 weeks after the last study visit (due to early termination the last visit was on 19 July 2011)|Safety population consisted of all randomized participants who were exposed to IPs with the exception of any participant with documented evidence of not having consumed any amount of IP.|||Participants|||Count of Participants
1407393|NCT01199731|Primary|Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies Per Milliliter (/mL) at Week 16|Plasma for quantitative HIV-1 RNA was collected. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 16 has been presented. A 2 ml plasma was assayed with the real-time NucliSens EasyQ HIV-1 assay (bioMerieux) capable of quantifying as low as 2.5 c/mL by using three modifications to the standard assay: 15 microliters (µl) of extracted eluate, 20 µl of primer, and 5 µl of 2X enzyme in place of standard kit volumes. The validated assay incorporated molecular beacons for detection.|At Week 16|Intent-to-Treat-Exposed (ITT-E) consisted of all randomized participants who received at least one dose of investigational product (IP). Only those participants with data available at the indicated time point were analyzed.|||Percentage of participants|||Number
1407394|NCT01199705|Secondary|Rate of Mild, Moderate, or Severe Local Reactions|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.~Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 36 weeks|The SDS comprised all subjects treated with the study drug.|||AEs per infusion|Participants||Number
1407395|NCT01199705|Secondary|Rate of All Adverse Events by Relatedness and Seriousness|The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|For the duration of the study, up to 36 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.|||AEs per infusion|Participants||Number
1407396|NCT01199705|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks||||Days||Full Range|Median
1407397|NCT01199705|Secondary|Number of Days of Hospitalization Due to Infections by Study Period|Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks||||Days||Full Range|Median
1407410|NCT01199471|Secondary|Time to Intubation of Patients|The time to intubation of the patients was measured from the commencement of administration of anesthesia to intubation of each patient.|Up to 10 minutes|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
1407398|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)~SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.|||SBIs per subject year|Participants||Number
1407399|NCT01199705|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).|Up to 36 weeks||||Days||Full Range|Median
1407400|NCT01199705|Other Pre-specified|Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)~SCIG IgPro20 treatment (efficacy; 12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.|||SBIs per subject year|Participants||Number
1407401|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)~SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.|||Infections per subject year|Participants||Number
1407402|NCT01199705|Secondary|Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population|"The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.~Study periods:~IVIG treatment (up to 12 weeks)~SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)~SCIG IgPro20 treatment (efficacy) (12 weeks)"|Up to 36 weeks|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.|||Infections per subject year|Participants||Number
1407403|NCT01199705|Secondary|Number of Infection Episodes (Serious and Non-serious) by Study Period|"Number of infection episodes (serious and non-serious) presented by study period:~IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).~SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.~SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy."|Up to 36 weeks||||Number of infection episodes|||Number
1407404|NCT01199705|Primary|IgG Trough Level|Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.|During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.|||Ratio of Geometric Means||90% Confidence Interval|Number
1407405|NCT01199601|Secondary|Completion of 9 Month Measles-mumps-rubella Vaccination on Time.|Assess whether patients randomized to the intervention were more likely to have children receiving the measles-mumps-rubella vaccination at 9 months of age after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months||||participants|||Number
1407406|NCT01199601|Secondary|Correct Breastfeeding Practices to 1 Year|Assess whether patients randomized to the intervention exhibit correct breastfeeding practices (a composite variable in which exclusive breastfeeding occurs to 6 months and continued complementary breastfeeding continues to 12 months) after receiving concentrated postpartum counseling compared to women receiving standard of care.|12 months||||participants|||Number
1407407|NCT01199601|Primary|Utilization of Postpartum Contraception|Determine whether the re-training and assignment of healthcare providers dedicated to intrapartum rapid testing and intensive post-partum counseling will positively impact postpartum contraceptive use as compared to any counseling provided by existing health providers for these services among women delivering in public health maternity hospitals in Kabul, Afghanistan.|12 months|Participants included in analysis were those completing the 6 and 12 month follow-up visits.|||participants|||Number
1407408|NCT01199471|Secondary|Time to Extubation of Patients|The time to extubation of patients was measured from cessation of anesthesia administration to tracheal extubation of the patient.|Every minute after cessation of anesthesia until the patient was extubated|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
1407411|NCT01199471|Secondary|Time to Loss of Consciousness of Patients Administered Anesthesia|The time to loss of consciousness was measured from commencement of administration of anesthesia to the patient's loss of consciousness (no response to command).|Up to 10 minutes|All available data were included in the analysis.|||minutes||Standard Deviation|Mean
1415796|NCT01132547|Primary|Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline||8 weeks|LOCF|||participants|||Number
1407412|NCT01199471|Primary|Patient Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Patient satisfaction with the anesthesia recorded at the end of the operation within 24 hours using a numeric analog scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1407413|NCT01199471|Primary|Anesthesiologist Satisfaction With the Anesthesia Recorded at the End of the Operation Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia administered to each patient during surgery was recorded at the end of the operation using a Numeric Analog Scale (NAS) from 0 (not satisfied at all) to 10 (completely satisfied) are summarized.|Within 24 hours|400 participating anesthesiologists evaluated their satisfaction with anesthesia (sevoflurane) administered to patients during surgery. All available data for 3,993 patients are included and summarized.|||units on a scale||Standard Deviation|Mean
1407414|NCT01199237|Secondary|Time From Anesthetic Discontinuation to First Ability to Swallow|At 2 minutes after first response to command (T1), the patient was asked to swallow 20 mL of water from a paper cup, and an observer blinded to anesthetic assignment assessed the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag (indicating misdirection of the water bolus into the laryngeal inlet). This test was repeated at 6, 14, 22, 30 and 60 minutes after the time of first response to command.|up to 60 minutes after T1||||Seconds||Full Range|Mean
1407415|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|60 minutes after T1|Only patients able to respond at time of assessment|||units on a scale||Full Range|Mean
1407416|NCT01199237|Secondary|Nausea and Vomiting|Patients were asked to rate their experience of nausea and vomiting on a 0-10 verbal analog scale, with 0 being absence and 10 being the worst imaginable|30 minutes after T1|Only participants able to respond at time of assessment|||units on a scale||Full Range|Mean
1407417|NCT01199237|Secondary|Time From Potent Inhaled Anesthetic Discontinuation to First Response to Command (T1)|"At the conclusion of surgery, after the patient's potent inhaled anesthetic was discontinued, the commands open your eyes and squeeze my hand were given at 30-second intervals. The time at which patient first appropriately response to both commands was noted as T1."|Up to 1 hour post-operative||||seconds||Full Range|Mean
1407418|NCT01199237|Primary|Recovery of Ability to Swallow After Neostigmine/Glycopyrrolate Antagonism of Rocuronium Paralysis.|The patient is judged by the primary anesthetist to be awake at time T1. At 2 minutes after T1, the patient was asked to swallow 20mL of water from a paper cup, and a blinded observer judged the ability to swallow based on transit of water to the posterior pharynx (absence of pooling or drooling) and absence of cough or gag.|At 2 minutes after response to command (T1).|Only participants judged by the clinician as able to take the test (n=57)|||participants|||Number
1407419|NCT01199146|Secondary|Proportion of Patients With PSA Decline of > 50%||12 weeks from beginning of therapy||||Participants|||Count of Participants
1407420|NCT01199146|Secondary|Time To Progression (TTP)||beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria||||weeks||Full Range|Median
1407421|NCT01199146|Primary|Preliminary Evidence of Efficacy of Abiraterone Acetate|number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment|12 weeks from beginning of abiraterone treatment||||Participants|||Count of Participants
1407422|NCT01199042|Secondary|Average Therapy Pressure Values|"To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time.~This analysis compares the average pressure support of the first week compared to the average pressure support to the final week."|3 months|26 participants completed the 3-month home follow-up.|||cm/H2O||Standard Deviation|Mean
1407423|NCT01199042|Secondary|Breathing Event Indexes|"To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy.~Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment."|from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment|26 participants completed the 3-month home follow-up.|||Apnea-Hypopnea events per hour||Standard Deviation|Mean
1407424|NCT01199042|Secondary|Epworth Sleepiness Scale|"To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24.~Interpretation:~Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention.~Score 16-24: Excessive sleepiness and patient should consider seeking medical attention~A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness."|3 months|26 participants completed the 3-month home follow-up.|||units on a scale||Standard Deviation|Mean
1407425|NCT01199042|Primary|Apnea/Hypopnea Index (AHI)|To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.|During a single night of polysomnography lasting up to 8 hours.||||Apnea-Hypopnea events per hour||Standard Deviation|Mean
1407426|NCT01199016|Other Pre-specified|Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Healthy Participants|Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.|Baseline up to Month 36|NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.|||percentage of NP/OP samples|NP/OP Samples||Number
1408021|NCT01195090|Secondary|Changes in Fasting Plasma Glucose|fasting serum sugar change from baseline to 24 weeks|24 weeks|An intent-to-treat (ITT) analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
1407427|NCT01199016|Other Pre-specified|Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)|MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.|Baseline up to Month 36|MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.|||percentage of MEF samples|MEF Samples||Number
1407428|NCT01199016|Other Pre-specified|Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants|Total percentage of NP/OP samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.|Baseline up to Month 36|NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.|||percentage of NP/OP samples|NP/OP Samples||Number
1407429|NCT01199016|Primary|Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)|MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.|Baseline up to Month 36|MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.|||percentage of MEF samples|MEF Samples||Number
1407430|NCT01198977|Other Pre-specified|Physical Activity (Behavioral Target)|First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.|||units on a scale||Standard Error|Mean
1407431|NCT01198977|Secondary|Depression|"Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).~Total Score for 9 items = 27."|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.|||units on a scale||Standard Error|Mean
1407432|NCT01198977|Primary|Fatigue|Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.|baseline, 3 months, 6 months|Veterans with MS from Veterans Affairs (VA) Puget Sound Health Care System and civilians with MS from the greater Puget Sound area. Note: Telephone Counseling Group: 1=lost to follow-up, so analyzed 30 participants instead of 31.|||units on a scale||Standard Error|Mean
1407433|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Function|"left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)||||centimeters/second||Standard Deviation|Mean
1407434|NCT01198873|Secondary|Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)|"Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined|||percentage of blood pumped out||Standard Deviation|Mean
1407435|NCT01198873|Secondary|Changes From Baseline in Left Atrial Dimension|"Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined|||centimeters||Standard Deviation|Mean
1407436|NCT01198873|Secondary|Changes From Baseline in Left Atrial Function|"left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|Modified intent-to-treat population as previously defined|||mililiters||Standard Deviation|Mean
1407477|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407437|NCT01198873|Primary|Change From Baseline in Left Atrial Volume Index (LAVi)|"Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.~Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis."|baseline (before randomization) and post-baseline (after 3-12 months of treatment)|"The analysis included all randomized and treated participants with at least one post-baseline echocardiographic assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).~The quality of the post-baseline echocardiography was inadequate for determining LAVi in one participant."|||mililiters/m2||Standard Deviation|Mean
1407438|NCT01198795|Primary|Patients With Any Treatment Emergent Adverse Events (TEAEs)|The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,|From Baseline (Week 0) to Week 26||||participants|||Number
1407439|NCT01198769|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (from Dose 1 at Day 0 up to Month 4)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1407440|NCT01198769|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) follow-up period after vaccination|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1407441|NCT01198769|Secondary|Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.|"RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.~GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA)."|From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1407442|NCT01198769|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.|During the 8-day (Days 0-7) post-vaccination period|The Total vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1407443|NCT01198769|Secondary|Serum Anti-rotavirus IgA Antibody Concentrations.|Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.|||U/mL||95% Confidence Interval|Geometric Mean
1407444|NCT01198769|Primary|Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.|Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL.|2 months post-Dose 2 (at study Month 4)|The According-To-Protocol cohort for immunogenicity included subjects who received Hepatitis B immunoglobulin after birth, who were seronegative for serum anti-RV IgA antibody at Day 0, who complied with vaccination schedule for the Rotarix vaccine, who had no RV other than the vaccine strain in gastroenteritis stool sample up to Month 4.|||Subjects|||Number
1407445|NCT01198756|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1407446|NCT01198756|Secondary|Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1407447|NCT01198756|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination|"Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination."|During the entire study period (from Day 0 to Day 180)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1407448|NCT01198756|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.|During the 28-day follow-up period (Day 0-27) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1407449|NCT01198756|Secondary|Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination|Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Days||Inter-Quartile Range|Median
1407450|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Days||Inter-Quartile Range|Median
1407451|NCT01198756|Secondary|Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||Days||Inter-Quartile Range|Median
1407452|NCT01198756|Secondary|Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||subjects|||Number
1407453|NCT01198756|Secondary|Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms|Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||subjects|||Number
1407454|NCT01198756|Secondary|Number of Days With Solicited Local Symptoms After Vaccination|Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Inter-Quartile Range|Median
1407455|NCT01198756|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.|||subjects|||Number
1407456|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||fold increase||95% Confidence Interval|Geometric Mean
1407457|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407458|NCT01198756|Secondary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||subjects|||Number
1407459|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1407460|NCT01198756|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||fold increase||95% Confidence Interval|Geometric Mean
1407461|NCT01198756|Secondary|Number of Subjects Seroprotected Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407462|NCT01198756|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1407463|NCT01198756|Primary|Number of Subjects Seroconverted Against 4 Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.|||subjects|||Number
1407513|NCT01198132|Secondary|Changes From Baseline in Measured Lesion Load (T2)|Baseline defined as last value recorded prior to first intake of study drug.|Baseline, Week 96|ITT set included all randomized subjects. Here “n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||cubic millimeter (mm^3)||Standard Deviation|Mean
1417717|NCT01118845|Secondary|Number of Subjects With Grade ≥3 Physical Examination Finding||up to 30 weeks||||Participants|||Number
1407464|NCT01198756|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.|At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable and eligible subjects for whom data concerning immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1407465|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|Patient satisfaction will be assessed 6 weeks later at their post-op visit||||participants|||Number
1407466|NCT01198691|Secondary|Patient Satisfaction|"Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients strongly agree, agree, disagree, or strongly disagree with the statement, I am satisfied with the overall appearance of my incision. Those who responsed agree or strongly agree were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied."|This will be assessed 3 day after the patient's C-section before they are discharged from the hospital||||participants|||Number
1407467|NCT01198691|Primary|Post Operative Pain (3 Days Post-op)|Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year||||units on a scale||Standard Deviation|Mean
1407468|NCT01198691|Primary|Post Operative Pain|Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.|1 Year||||units on a scale||Standard Error|Mean
1407469|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407470|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407471|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 27 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 43|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407472|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407473|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407474|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 14 days. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 15|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407475|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1407476|NCT01198600|Primary|Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10|Ocular comfort was rated bilaterally by the participant after wearing the same pair of lenses for 1 day. Ocular comfort was recorded on a continuum and converted to a 100-point scale where 1=EXTREMELY UNCOMFORTABLE (“I CANNOT tolerate the comfort of my eyes! I am in pain!”)and 100=VERY COMFORTABLE & FRESH (“Wow! My eyes feel incredible! I love this feeling.”)|Day 1|All enrolled and dispensed participants, Phase 3.|||Units on a scale||Standard Deviation|Mean
1408022|NCT01195090|Primary|Mean Change in Glycosylated Hemoglobin (A1C)|A1C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||percentage of Hb||Standard Error|Least Squares Mean
1407478|NCT01198587|Secondary|Assess Parent Reporting Reliability Comparing Survey Responses to Phone Interview.|Kappa inter-rater reliability measurement was done to analyze the agreement between the phone call data with parents reporting the number of episodes of diarrhea per day were compared to the written symptom charts where parents recorded the number of episodes of diarrhea per day. The inter-rater reliability ranges from 0 to 1 with scores of 0-0.2 = poor agreement, 0.2-0.4 = fair agreement, 0.4-0.6 = moderate agreement, 0.6-0.8 = good agreement and 0.8-1 = very good agreement|agreement over the 14 day follow up period|All patients enrolled in the study|||kappa statistic|||Number
1407479|NCT01198587|Secondary|Examine the Potential Cost Benefits of Supplementation With Zinc in Reducing Number of Daycare Days Not Attended and Work Days Lost by Parents||over the 14 day symptom monitoring period||||Hours||Standard Deviation|Mean
1407480|NCT01198587|Primary|Duration of Diarrhea in Acute Diarrheal Illnesses in a Developed Nation While Taking Zinc or Placebo.|Patients symptoms will be assessed to identify the duration of diarrhea between zinc and placebo groups before it becomes chronic diarrhea which by definition lasts longer than 14 days. Outcome of all patients in study will be assessed at study conclusion.|14 days|The study failed to enroll sufficient inpatients due to the low hospitalization rate in the US for children who are otherwise healthy with diarrhea All patients were analyzed separately by arm and then again together for overall severity of diarrhea|||Hours||Standard Deviation|Mean
1407481|NCT01198574|Primary|Status of Cellular Iron Deficiency|Cellular Iron deficiency status is also measured by serum transferrin receptor|at week 0, week 6 and week12|Per Protocol analysis|||mg/L||Standard Deviation|Geometric Mean
1407482|NCT01198574|Primary|Status of Tissue Iron Store|Tissue iron store was measured by serum ferritin|at week 0, week 6 and week12|Per Protocol analysis|||µg/L||Standard Deviation|Geometric Mean
1407483|NCT01198574|Primary|Haemoglobin Level|Haemoglobin level (g/L) measured by cyanmethaemoglobin method|at week 0, week 6 and week12|Per Protocol|||g/L||Standard Deviation|Mean
1407484|NCT01198548|Secondary|PFS of Patients Receiving Study Treatment|"The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method.~3 Year Survival Rate"|Defined as the time from the start of the study treatment until the date of progression or death from any cause, whichever comes first, assessed up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1407485|NCT01198548|Secondary|OS of Patients Receiving Study Treatment|The estimated distribution of OS will be obtained using the product-limit based Kaplan-Meier method.|Up to 3 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1407486|NCT01198548|Secondary|Toxicity Rates as Assessed by NCI CTCAE Version 4||Up to 30 days post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1407487|NCT01198548|Secondary|RR of Patients Receiving Study Treatment||Up to 3 years|Trial terminated early. Too few patients to analyze.||||||
1407488|NCT01198548|Primary|Rate of Sufficient Cholecalciferol||By week 16|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1407489|NCT01198548|Primary|Median PFS|The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.|Up to 12 months|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1407490|NCT01198509|Secondary|Mean Units Change in DAS28 From Baseline to 6 Months|"DAS28 (disease activity score with 28 joint count). Possible score range: 0 to 10. This is a composite index calculated from 4 measures: two from a physician (28 tender joint count, 28 swollen joint count), one from the patient (patient global estimate of disease activity), and one laboratory biomarker (erythrocyte sedimentation rate or ESR). A score of 0 represents best possible health status (no apparent disease activity) and 10 represents worst possible.~The outcome is reported as mean change in DAS28 score from baseline to 6 months. The mean changes reported are negative values for downward change in score (i.e., improvement in health status)."|6 months|Please note that only the first 3 groups (RA doxycycline, RA vancomycin, and RA randomized to no treatment) were analyzed for change from baseline to six months (outcomes). Groups 4, 5 and 6 (RA cross-sectional, Psoriatic Arthritis, and Healthy Volunteers) were analyzed for baseline measures only in a cross-sectional comparison.|||units on a scale||Full Range|Mean
1407491|NCT01198509|Primary|Alteration of Microbiota, Alteration of T Cell Function/Activation|"Oral and intestinal microbiota, and T cell function and activation, will be assessed at baseline, and at 1, 2, 3, 4 and 5 months after baseline, to determine whether changes are associated with vancomycin treatment versus doxycycline treatment versus no treatment.~Results are reported as number of participants who experienced changes in oral/intestinal microbiota, T cell function/activation.~Methods/criteria to assess change in microbiota: change in relative abundance of microorganisms at genus and species level (as assessed high-throughput 16S rDNA sequencing).~Methods/criteria to assess change in T cell function/activation: change in percentage of inhibition of regulatory T cells as measured by interferon gamma levels in in-vitro assays."|6 months|Primary outcome only evaluated in first three groups of RA patients: 4 randomized to treatment with doxycycline; 10 randomized to treatment with vancomycin; 19 randomized to no treatment.|||participants|||Number
1407492|NCT01198366|Secondary|Percentage of Subjects Converting From a Negative QuantiFERON Test (QFT) to Positive QFT After Vaccination|To evaluate the proportion of on-study QuantiFERON conversions from negative to positive in infants that received AERAS-402 compared to controls. A QFT value of on >= 0.35IU/mL was considered positive for this study.|up to 24 months post vaccination|Subjects who received at least one vaccination and had results at baseline and end of study.|||% converting from QFT neg to pos|||Number
1407493|NCT01198366|Secondary|Antigen-specific Antibody Response - Mean Optical Density (Mean OD)|To evaluate the immunogenicity of AERAS-402 compared to controls by ELISA Assay for Antigen-specific Antibody Response. Median responses of individual Mean OD (absorbance at 450nm) by study group is presented. Higher OD values suggests the presence of antibody to each of the Mtb antigens (Ag85A, Ag85B and TB10.4).|28 day post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Ag85A and TB10.4).~Assays were not done for groups 2 and 3 for any antigen. Group 5: Subjects who received all three study vaccinations as randomized."|||Optical Density||95% Confidence Interval|Median
1433677|NCT00983645|Primary|Rejection||6 months post-transplant|Data cannot be located for analysis.||||||
1407494|NCT01198366|Secondary|Interferon-gamma (IFN-gamma) Enzyme-linked Immunospot (ELISpot) Response: Spot Forming Units/10^6 PBMC According to ELISpot Assay|To evaluate the immunogenicity of AERAS-402 compared to controls. ELISpot assay of specific T cell responses after stimulation with a peptide pool of mycobacterial peptides. Values presented have been corrected for background readings.|28 days post last vaccination|"Groups 1 and 4: Subjects who received both vaccinations as randomized (assays were not done for Groups 2 and 3).~Group 5: Subjects who received all three study vaccinations as randomized."|||SFU/10^6 PBMC||95% Confidence Interval|Median
1407495|NCT01198366|Secondary|Percentage of Cells Expressing Various Cytokines Will be Measured by Intracellular Cytokine Staining (ICS) in All Subjects|To evaluate the immunogenicity of AERAS-402 compared to controls, flow cytometric ICS of CD4 and CD8 T cells producing any of three cytokines (IFN-γ, TNF-α, and/or IL-2) alone or in combination after stimulation with a peptide pool of mycobacterial peptides. Dimethylsulfoxide (DMSO) subtracted responses are presented.|28 days post last vaccination|Groups 1–4: Subjects who received both vaccinations as randomized. Group 5: Subjects who received all three study vaccinations as randomized.|||percentage of Tcell response||95% Confidence Interval|Median
1407496|NCT01198366|Primary|Adverse Events Collected Per Subject|Adverse Events (AEs) are recorded for 28 days post vaccination Serious Adverse Events (SAEs) are recorded for the entire study period to assess the safety profile|Up to 24 months post vaccination|Subjects who received at least one vaccination.|||percentage of subjects with an AE|||Number
1407497|NCT01198327|Secondary|Mean Change in Retinal Thickness|Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).|24 mos from study baseline||||microns||Standard Deviation|Mean
1407498|NCT01198327|Secondary|Mean Changes in Visual Acuity|Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.|24 mos from study baseline||||ETDRS letters||Standard Deviation|Mean
1407499|NCT01198327|Primary|Incidence of Serious Adverse Events.|Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.|24 mos||||number of serious adverse events|||Number
1407500|NCT01198275|Primary|Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)|Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.|one year||||partecipants|||Number
1407501|NCT01198275|Secondary|The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence|The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.|1, 3 and 6 months||2011-07-31|07/2011||||
1407502|NCT01198145|Secondary|Percentage of Patients in Each Arm That Experience Clinically Significant Deficits in Overall Quality of Life and Fatigue|For each arm, the percentage of patients experience clinically significant deficits in overall QOL and fatigue as indicated by a score of 5 or lower on the 0-10 scale. The analysis was done using the questionnaire that was completed during the first week of radiotherapy (RT) and 6 weeks after RT.|Up to 6 weeks post radiotherapy|All completed QOL questionnaires were included in the analysis. Questionnaires used were completed during the first week during RT and 6 weeks after RT. From Arm I, 41 patients completed questionnaires, 39 during and 26 after RT. For Arm II, 42 patients completed the questions, 40 during and 29 after RT.|||percentage of participants|||Number
1407503|NCT01198145|Secondary|Percentage of Patients in Each Arm That Require Any Type of Antidiarrheal Medications.|The number of patients reporting the use of anti-diarrheal medications divided by the number of patients evaluated for this endpoint.|Up to 24 months post radiotherapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations.|||percentage of participants|||Number
1407504|NCT01198145|Secondary|"Percent of Patients in Each Arm That Recorded Yes to Each of Questions 2-10 on the Bowel Function Questionnaire"|"Questions that were used in this analysis:~2. Have you had a problem causing you to get up at night to have a bowel movement? 3. Have you had a problem causing you to lose control of your bowel movements? 4. Have you had a problem causing you to have a bowel movement within 30 minutes of a prior bowel movement? 5. Have you had to wear protective clothing or a pad in case you lost control of a bowel movement? 6. Have you had a problem causing you to be unable to tell the difference between stool and gas? 7. Have you had a problem causing you to have stools that are liquid? 1=yes 2=no q08 8. Have you found that once you feel the urge to have a bowel movement, you must do so within 15 minutes to avoid an accident? 9. Have you had cramping with a bowel movement? 10. Have you had blood in your bowel movement?"|Up to 6 weeks post radiation therapy|All patients that completed the questionnaire were included in the analysis. Questionnaires used were completed during the last week during RT and 6 weeks after RT.|||percentage of participants|||Number
1407505|NCT01198145|Secondary|Percentage of Patients in Each Arm That Experience Tenesmus, Abdominal Pain, Constipation, Diarrhea and Rectal Bleeding During and After RT|The number of patients that reported any grade 1 or higher adverse event was divided by the total number of patients evaluated. The analysis was done separately for each of the 5 outcomes and separately during RT and after RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||percentage of participants|||Number
1407514|NCT01198132|Secondary|Number of New or Extended Lesions by T1- and T2-Weighted Magnetic Resonance Imaging (MRI)||2 years post treatment (IMP) administration|"ITT set included all randomized subjects. Here Number of participant analyzed signifies those subjects who were evaluable for this outcome measure."|||lesions||Standard Deviation|Mean
1408210|NCT01193608|Other Pre-specified|CSF Tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
1407506|NCT01198145|Secondary|Average Graded Severity for Tenesmus, Abdominal Pain, Constipation, Diarrhea and Hemorrhage During and After RT as Graded by CTCAE v4.0|Tenesmus, Abdominal pain, constipation, diarrhea and hemorrhaging were assessed during RT and up to 6 weeks after RT. Severity of these events were graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. For each patient, an average score for each outcome variable during and after RT calculated as follows: The sum of all severity scores for that variable divided by the number of severity scores for that variable recorded for the patient during the course of RT and for 6 weeks following RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||Average Grade of Event||Standard Deviation|Mean
1407507|NCT01198145|Secondary|Area Under the Curve That Combines the Individual Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After RT|For each patient, an Area Under the Curve (AUC) summary statistic will be calculated taking into account the individual severity of diarrhea toxicity over time. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. The curve was constructed using weekly assessments during and after RT. A separate analysis was done during the course of RT and every week for 6 weeks following RT.|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used in that portion of the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||grade*week||Standard Deviation|Mean
1407508|NCT01198145|Secondary|Maximum Severity of Each Outcome Variable (Rectal Bleeding, Abdominal Cramping, Tenesmus, Constipation, and Diarrhea) Measured During and After RT|"The maximal severity of each of 5 different adverse even types (Tenesmus, Abdominal Pain, Constipation, Diarrhea, and Rectal Bleeding) were collected as a secondary endpoint. Severity of the events was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening. Adverse events were assessed during the course of RT and for 6 weeks following RT. The table below represents the worst grade for each patient for each type.~Two-sided chi-square tests will be used to compare each percentage variable between treatment arms for each event type."|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the endpoint analyses due to cancellations and protocol violations. 42 patients from each arm started RT and were used for the analysis. 25 patients from Arm I and 29 patients from Arm II were evaluated after RT. Two patients from Arm 1 provided incomplete data.|||Participants|||Count of Participants
1407509|NCT01198145|Primary|Maximum Severity of Diarrhea Toxicity as Measured by the CTCAE v4.0 During and After Radiotherapy (RT)|"The primary endpoint for this study is the maximal severity of diarrhea toxicity. Severity of diarrhea was graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Grade 0 = None; 1=Mild; Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening as measured by the CTCAE version 4.0. Assessments were recorded during the course of RT and for 6 weeks following RT. The table below represents the worst graded diarrhea for each patient.~A two-sided Wilcoxon rank-sum test will be used to test the equality of the distributions of maximum diarrhea severity grades between the two treatment arms."|During radiation therapy and up to 6 weeks post radiation therapy|Two patients in Arm I and one patient from Arm II were not included in the baseline analysis nor the endpoint analyses due to cancellations and protocol violations.|||Participants|||Count of Participants
1407510|NCT01198132|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Abnormal Clinical Laboratory|A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and TEAE was defined as newly occurring or worsening after first dose. Clinical laboratory abnormalities are expected to be reported as adverse events if they met any criterion for seriousness, led to treatment discontinuation, required a medical intervention or were considered clinically significant by the investigator.|Baseline up to end of treatment (week 96)|Safety set included all subjects who receive at least one administration of trial medication.|||subjects|||Number
1407511|NCT01198132|Secondary|Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L)|The EQ-5D health questionnaire is a generic self-reported health-related quality of life instrument that includes a 100 mm Visual Analog Scale (VAS) to measure the general health state, as well as 5 items corresponding to one dimension each: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the VAS scale is not collected and the version 3L of the scale was used: Each dimension had 3 possible levels: 1 = no problem, 2 = some problems and 3 = extreme problems. EQ-5D-3L weighted health state index exists that combines the score of the 5 dimensions and ranges from 0 to 1 (full health). The variables for the 5 dimensions of the EQ-5D descriptive system was named 'mobility','selfcare', 'activity', 'pain', and 'anxiety'. The 5 variables contained the values for the different dimensions in the EQ-5D health profile (i.e. 1, 2, or 3).|2 years post treatment (IMP) administration|ITT set included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1407512|NCT01198132|Secondary|Change From Baseline in Measurement and Evaluation of Cognitive Ability by Paced Auditory Serial Addition Task (PASAT) Total Score At Week 96|The Adapted Paced Auditory Serial Addition Task (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The total score for PASAT is the total number of correct answers (out of 60, for a total possible score ranging from 0-60 with higher score indicates higher auditory processing speed) for each trial. Change from baseline in PASAT total score at Week 96 was summarized.|Baseline, Week 96|ITT set included all randomized subjects.|||units on a scale||Standard Deviation|Mean
1409153|NCT01188460|Secondary|Pain Disability Index (PDI)|Measures pain disability impact on various life domains, scores range from 0-70, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
1407515|NCT01198132|Secondary|Cumulative Probability of Progression of Disability (Kaplan-Meier Curves)|Disability progression was assessed using Expanded disability status scale (EDSS). EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A one-point increase on the EDSS scale was considered as a progression in disability. The time to disability progression was summarized using Kaplan-Meier survival methods. The cumulative probability of confirmed disease progression at each visit was obtained by applying a Kaplan-Meier method to the time to confirmed disease progression.|Baseline up to week 96|"ITT set included all randomized subjects. Here Number of participant analyzed signifies those subjects who were evaluable for this outcome measure."|||percentage of subjects|||Number
1407516|NCT01198132|Secondary|Number of Relapse-Free (Documented) Subjects|The relapse-free patients after 2 years of treatment was calculated using Cochran-Mantel-Haenszel test using the site as control variable.|2 years post treatment (IMP) administration|"ITT set included all randomized subjects. Here Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||subjects|||Number
1407517|NCT01198132|Secondary|Mean Number of Relapses Per Subject|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Mean and standard deviation were reported.|2 years post treatment (IMP) administration|ITT set included all randomized subjects.|||relapses||Standard Deviation|Mean
1407518|NCT01198132|Secondary|Time to First Documented Relapse|Time to First Documented Relapse was calculated using Kaplan-Meier survival methods.|2 years post treatment (IMP) administration|"ITT set included all randomized subjects. Here Number of participant analyzed signifies those subjects who were evaluable for this outcome measure."|||weeks||95% Confidence Interval|Median
1407519|NCT01198132|Primary|Annualized Relapse Rate|The annualized relapse rate was calculated for each treatment group as follows: the number of relapses observed during the study period divided by the time spent in the study (in years).|2 years post treatment (IMP) administration|ITT set included all randomized subjects.|||Relapse per year||95% Confidence Interval|Mean
1407520|NCT01198002|Other Pre-specified|Number of Participants Who Died During Post-Treatment Follow-Up Period||Discontinuation from study treatment up to 48 weeks during follow-up period|All randomized participants who received at least 1 dose of study drug and entered post-treatment follow-up period.|||Participants|||Count of Participants
1407521|NCT01198002|Secondary|Change From Baseline in CRP|CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||milligrams/liter (mg/L)||Standard Error|Least Squares Mean
1407522|NCT01198002|Secondary|Time to ACR20 Response|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.|Baseline through 52 weeks|All randomized participants with evaluable ACR20 responder data. The number of participants censored are 128 (120 mg LY2127399), 123 (90 mg LY2127399) and 162 (placebo).|||weeks||95% Confidence Interval|Median
1407523|NCT01198002|Secondary|Percentage of Participants With ACR20 at Week 52|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders) /( number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 52 endpoint.|Baseline through 52 weeks|All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1407524|NCT01198002|Secondary|Change From Baseline to Week 52 in Absolute B Cell Counts|Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable CD3-CD20+ B cell counts. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||cells/microliter (cells/µL)||Standard Error|Least Squares Mean
1407525|NCT01198002|Secondary|Change From Baseline to Week 52 in HAQ-DI|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable HAQ-DI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1407526|NCT01198002|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity (VAS)|Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable physician's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
1407527|NCT01198002|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity (VAS)|Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable participant's global assessment of disease activity data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||mm||Standard Error|Least Squares Mean
1407528|NCT01198002|Secondary|Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]|Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable participant's assessment of pain data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1407529|NCT01198002|Secondary|Change From Baseline in Swollen Joint Count (66 Joint Count)|Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable swollen joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
1407530|NCT01198002|Secondary|Change From Baseline in Tender Joint Count (68 Joint Count)|Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable tender joint count data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||joint counts||Standard Error|Least Squares Mean
1407531|NCT01198002|Secondary|American College of Rheumatology Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.|Baseline through 24 weeks and 52 weeks|All randomized participants with evaluable ACR-N data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of improvement||Standard Error|Least Squares Mean
1407532|NCT01198002|Secondary|Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||units on a scale||Standard Error|Least Squares Mean
1407533|NCT01198002|Secondary|Change From Baseline in Serum Immunoglobulin (Ig) Levels|Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable serum Ig data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||grams/liter (g/L)||Standard Error|Least Squares Mean
1407534|NCT01198002|Secondary|Change From Baseline to Week 24 in mTSS|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||units on a scale||Standard Error|Least Squares Mean
1407535|NCT01198002|Secondary|Percentage of Participants With No Structural Progression at Week 52|No structural progression is defined as the change in mTSS from baseline ≤0. The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) * 100.|Baseline through 52 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||percentage of participants|||Number
1407536|NCT01198002|Secondary|Percentage of Participants Developing Anti-LY2127399 Antibodies|Participants with treatment-emergent anti-drug antibodies (ADA) were participants who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.|Baseline through 52 weeks|All randomized participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result. Participants missing an evaluable baseline result with all negative post-baseline results were included. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1407537|NCT01198002|Secondary|Population Pharmacokinetics (PK): Constant Clearance|Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.|Baseline through 52 weeks|All randomized participants who received at least 1 dose of LY2127399 with evaluable LY2127399 PK data.|||milliliter per hour (mL/h)||95% Confidence Interval|Mean
1407538|NCT01198002|Secondary|Change From Baseline to Week 52 in B Cell Subset Counts|B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional [CD19+immunoglobulin D (IgD)-CD27-], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 weeks|All randomized participants with evaluable B cell subset counts data. mLOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||cells/microliter (cells/µL)||Standard Error|Least Squares Mean
1407539|NCT01198002|Secondary|Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) * 100.|Baseline through 24 weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||percentage of participants|||Number
1407540|NCT01198002|Secondary|Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks||Baseline through 52 weeks|Zero participants analyzed. Per protocol and statistical analysis plan (SAP) amendments, the major clinical response classification was not collected for analysis.||||||
1407541|NCT01198002|Secondary|Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores|The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable BPI-SF scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1407542|NCT01198002|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes)|The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable morning stiffness data; mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||minutes||Standard Error|Least Squares Mean
1407549|NCT01198002|Primary|Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)|The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.|Baseline, 52 Weeks|All randomized participants with evaluable mTSS data. A linear extrapolation method was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were included.|||units on a scale||Standard Error|Least Squares Mean
1445815|NCT00886340|Primary|Number of Participants Who Met Weight Loss Goal of 5% Weight Loss||6 months||||participants|||Number
1407543|NCT01198002|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score|The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable BFI data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1407544|NCT01198002|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores|SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If < 50% of the questions within a domain were answered, raw scores were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100. Higher score indicated better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable SF-36 domain and summary scores. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1407545|NCT01198002|Secondary|Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response|EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.|Baseline through 24 weeks and 52 weeks|All randomized participants with evaluable EULAR response data. Modified last observation carried forward (mLOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1407546|NCT01198002|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks and 52 weeks|All randomized participants with evaluable DAS28-CRP data. mBOCF was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1407547|NCT01198002|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response|ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No.) of ACR50 responders) / (No. of Pts treated) * 100. ACR70 Responder: had ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100. All NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints.|Baseline through 24 weeks and 52 weeks|All randomized participants with evaluable ACR50 or ACR70 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1407548|NCT01198002|Primary|Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.|Baseline, 24 weeks|All randomized participants with evaluable HAQ-DI data. Modified Baseline Observation Carried Forward (mBOCF) was used to impute missing post-baseline values. Data after Week 16 for Week 16 NR were not included.|||units on a scale||Standard Error|Least Squares Mean
1419030|NCT01107197|Secondary|Incidence of Infections|defined as local (ulcer)|8 weeks of nutritional support (baseline and week 8)||||participants|||Number
1407550|NCT01198002|Primary|Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24|ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint.|Baseline through 24 weeks|All randomized participants with evaluable ACR20 responder data. If participant's CRP was missing, last post-baseline value was used. If ACR was missing after carrying forward CRP, last post-baseline ACR response was used. Data after Week 16 for Week 16 NR were not included.|||percentage of participants|||Number
1407551|NCT01197911|Secondary|Number of Participants With Marked Abnormalities in Clinical Laboratory Parameters|Laboratory parameters included hematology, coagulation, biochemistry, and urinalysis. A marked abnormality was defined as a test result which was outside of the marked abnormality range. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
1407552|NCT01197911|Secondary|Number of Participants With Low and High Vital Signs Values|Vital signs were assessed after participants had rested in a supine position for no less than 5 minutes. Vital signs included systolic blood pressure, diastolic blood pressure, pulse rate, and oral body temperature. The normal ranges of vital signs were: systolic blood pressure as 90-140 millimeter of Hg (mm Hg), diastolic blood pressure as 50-90 mm Hg, pulse rate as 45-100 beats per minute, and oral body temperature as 36.3-37.5 degree Celsius. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Days -28 to -2, Day -1, Days 1 to 5, and Day 10 for blood pressure and pulse rate; and Days -28 to -2, Day -1, and Day 10 for oral body temperature|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
1407553|NCT01197911|Secondary|Number of Participants With Low and High Electrocardiograms (ECGs) Parameter Values|The ECG evaluations were performed after participants were at rest and in supine position for at least 5 minutes before recording and remain resting and supine during the recordings. ECGs parameters included heart rate (HR), RR interval, PR interval, QRS duration, QT interval, QTcB, and QTcF intervals. The normal ranges of ECG parameter values were: HR as 40-100 beats per minute, RR as 600-1500 milliseconds (msec), PR as 120-200 msec, QRS as 80-120 msec, QT as 200-500 msec, QTcB as 350-450 msec, and QTcF as 350-450 msec. Data was reported as the number of participants who had low level values (values less than the normal range) and high level values (values more than the normal range).|Screening (Days -28 to -2), baseline (Day -1), Days 1 to 5, and follow-up visit (Day 10)|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
1407554|NCT01197911|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), Death, and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 6 weeks|The safety analysis consisted of all participants who had received the single dose of the study drug (aleglitazar), whether prematurely withdrawn from the study or not.|||participants|||Number
1407555|NCT01197911|Secondary|Apparent Unbound Total Body Clearance (CL/Fu) of Aleglitazar|CL/F is an apparent total clearance of the drug from plasma after oral administration. It was calculated as dose/AUCinf. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific study drug/metabolite were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1407556|NCT01197911|Secondary|Apparent Unbound Volume of Distribution (Vz/Fu) of Aleglitazar|VzF/u is an apparent volume of Unbound distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||L||Geometric Coefficient of Variation|Geometric Mean
1407557|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to 48 Hours Post-dose (AUCu,0-48)|AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1411736|NCT01167829|Secondary|Maximum Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1407558|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From 0 to the Last Quantifiable Time-point Post-dose (AUCu,Last)|Plasma samples were collected for this PK parameter. AUClast represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero 0 to the last quantifiable time-point post-dose. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. AUClast was extrapolated to AUCinf by adding the ratio of Clast/kel to the AUClast, where Clast was the last observed concentration and kel was elimination rate constant.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407559|NCT01197911|Secondary|Maximum Unbound Plasma Concentration (Cmax,u) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407560|NCT01197911|Secondary|Area Under the Unbound Plasma Concentration-time Curve of Aleglitazar From Time 0 to Infinity (AUCu,Inf)|AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. It was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values. It was assessed using an analysis of variance model on the log-transformed values of AUCinf of aleglitazar with hepatic impairment group as factor.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407561|NCT01197911|Secondary|Mean of Fraction of Unbound Aleglitazar (fu)|fu was calculated using the mean of the 2-hour (reflecting Cmax) and 24-hour (reflecting Ctrough) values for each participant or, if the result of only one time-point was available, fu was the result of the available time-point. Ctrough) is a measured concentration at the end of a dosing interval at steady state.|2 and 24 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1407562|NCT01197911|Secondary|Fraction of Drug Excreted in Urine From Time 0 to 48 Hours Post-dose (fe0-48) of Aleglitazar|fe0-48 was calculated as Ae0-48/dose. The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours. Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed. Only participants with data available for specific study drug/metabolite were analyzed.|||mcg||Geometric Coefficient of Variation|Geometric Mean
1407563|NCT01197911|Secondary|Amount Excreted in Urine From Time 0 to 48 Hours Post-dose (Ae0-48) of Aleglitazar, M1, and M6|The cumulative amount excreted in urine Ae0-48 over the entire collection interval of 48 hours was calculated by adding the Ae of the intervals 0-4, 4-8, 8-12, 12-24, and 24-48 hours, where Ae was calculated by multiplying the urine volume within the collection interval by the associated drug concentration.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||mcg||Geometric Coefficient of Variation|Geometric Mean
1407564|NCT01197911|Secondary|Apparent Volume of Distribution (Vz/F) of Aleglitazar|Vz/F is the apparent volume of distribution during terminal phase after non-intravenous administration. It was calculated as CL/F/kel, where CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity and kel as constant elimination rate of aleglitazar.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||L||Geometric Coefficient of Variation|Geometric Mean
1407565|NCT01197911|Secondary|Elimination Rate Constant (Kel) of Aleglitazar|The kel is fraction of a substance that is removed per unit time measured at any particular instant. It was calculated using at least 3 concentration-time points and ideally covered more than 2 half-lives.|0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1407566|NCT01197911|Secondary|Apparent Terminal Half-life (t½) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h||Geometric Coefficient of Variation|Geometric Mean
1407567|NCT01197911|Secondary|Time of Maximum Plasma Concentration (Tmax) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Tmax was measured as time to reach the maximum concentration in the plasma after post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||h||Full Range|Mean
1409015|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug~severe nausea: repeated administration of antiemetic drugs~vomiting:...........at least one vomiting event"|8 hours after surgery|intention to treat|||participants|||Number
1407568|NCT01197911|Secondary|Apparent Non-renal Clearance (CLNR/F) of Aleglitazar|Plasma and urine samples were collected for this PK parameter. CLNR/F was estimated as CL/F, based on the approximated formula of CLNR/F = (CL-CLR)/F with CLR of aleglitazar being equal to zero. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time zero to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1407569|NCT01197911|Secondary|Renal Clearance (CLR) of Aleglitazar, M1, and M6|CLR was calculated as Ae0-48/AUC0-48, where Ae0-48 as amount excreted in urine from time 0 to 48 hours post-dose and AUC0-48 represents area under the concentration-time curve of the analyte in plasma over the time interval from zero to the 48 hours post-dose.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72, and 96 hours post-dose for plasma; 0-4, 4-8, 8-12, 12-24, and 24-48 hours post-dose for urine|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1407570|NCT01197911|Secondary|Apparent Total Body Clearance (CL/F) of Aleglitazar|CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol.|||L/h||Geometric Coefficient of Variation|Geometric Mean
1407571|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Quantifiable Time-point Post-dose (AUClast) of Aleglitazar, M1, and M6|AUClast was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407572|NCT01197911|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Post-dose (AUC0-48) of Aleglitazar, M1, and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUC0-48 was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407573|NCT01197911|Secondary|Cmax of M1 and M6|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407574|NCT01197911|Primary|Maximum Plasma Concentration (Cmax) of Aleglitazar|Cmax was obtained directly from the concentration-time data.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407575|NCT01197911|Secondary|AUCinf of M1 (RO4408754) and M6 (RO4583746)|M1 and M6 are pharmacologically inactive metabolites of aleglitazar. AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity. AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis population consisted of all participants who received the study drug and adhered to the protocol. Only participants with data available for specific metabolite were analyzed.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1407576|NCT01197911|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar|AUCinf was calculated by non-compartmental analysis using the linear trapezoidal rule, using relative actual time values.|Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 15, 24, 36, 48, 72 and 96 hours post-dose|The pharmacokinetics (PK) analysis population consisted of all participants who received the study drug and adhered to the protocol.|||hours (h)*nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1407577|NCT01197898|Primary|Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.|The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.|28 Days|Goal was to complete 10 subjects in an allocation ratio of 1:1 for Santyl vs. placebo. Since this was an exploratory study, the sample size was arbitrary.|||participants|||Number
1407578|NCT01197833|Primary|Absolute Change From Baseline in PA-V3 Score|The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from “Not at all noticeable” (a score of 0) to “Extremely noticeable” (a score of 4)|PA-V3 measured at baseline and then at 8 weeks||||score||Standard Error|Least Squares Mean
1409154|NCT01188460|Secondary|Pain Severity Rating|Measures pain severity, rated on scale from 0-10, total scores range from 0-40, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
1407579|NCT01197833|Primary|Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)|The Independent Photography Review – Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient’s visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient’s varicose veins in the medial section of each leg (a ‘live’ assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient’s varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient’s visible varicose veins.|IPR-V3 measured at baseline and then at 8 weeks||||score||Standard Error|Least Squares Mean
1407580|NCT01197794|Secondary|Total Reliever Medication Use|Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Number of inhalations||95% Confidence Interval|Least Squares Mean
1407581|NCT01197794|Secondary|Asthma Symptom Score|Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Score on scale||95% Confidence Interval|Least Squares Mean
1407582|NCT01197794|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S))|The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Score on scale||95% Confidence Interval|Least Squares Mean
1407583|NCT01197794|Secondary|Number of Participants With Well-controlled Asthma (ACQ5<=0.75)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5<=0.75 at the end of the 12-week treatment period.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Participants|||Number
1407584|NCT01197794|Secondary|Number of Participants With at Least One Treatment Failure|Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Participants|||Number
1407585|NCT01197794|Secondary|Number of Participants With at Least One Severe Asthma Exacerbation|Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Participants|||Number
1407586|NCT01197794|Secondary|Adverse Events|Number of participants who had at least one adverse event during the randomized treatment period|Twelve week treatment period|All randomized participants who received at least one dose of study medication and from whom any data after randomization was available|||Participants|||Number
1407587|NCT01197794|Secondary|Asthma Control Questionnaire 5-item (ACQ5)|The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Scores on scale||95% Confidence Interval|Least Squares Mean
1407588|NCT01197794|Secondary|Morning and Evening PEF|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Liters/minute||95% Confidence Interval|Least Squares Mean
1407589|NCT01197794|Primary|Pre-bronchodilator FEV1 at the Clinic|Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.|Twelve week treatment period|The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint|||Liters||95% Confidence Interval|Least Squares Mean
1407619|NCT01197547|Secondary|Serious Adverse Device Effect (SADE)|A secondary endpoint of the Genesys HTA Post Approval Study is to assess Serious Adverse Device Effects. Per the approved protocol, an SADE is an adverse device effect resulting in any of the consequences characteristic of a serious adverse event, or that might have led to any of these consequences if suitable action had not been taken or intervention had not been made, or if circumstances had been less opportune.|Day 1|992 - Intent-To-Treat (ITT) population|||number of participants|participants||Number
1407590|NCT01197755|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. The SF-36 scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in score at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1407591|NCT01197755|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item short form health survey, as a measure of health-related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with a mean of 50, standard deviation of 10. A higher score represents a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 24. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once daily|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1407592|NCT01197755|Secondary|Change From Baseline to Week 24 in mTSS Score, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for eroisions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = Analysis of covariance, BID = twice daily, IP = investigational product, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.|||Units on a scale||Standard Deviation|Mean
1407593|NCT01197755|Secondary|Proportion of Patients With a HAQ-DI Response at Week 24 - Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407594|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 24 was categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407595|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407596|NCT01197755|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients' own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407620|NCT01197547|Secondary|Technical Malfunctions|A secondary endpoint of the Genesys HTA Post Approval Study is to assess technical complaints (i.e. disposable and hardware issues). Technical complaints are issues related to system components encountered during the procedure such as error messages, problems with the connection, power, early incomplete procedure terminations, or display/user interface, or damage to the unit.|Day 1|992 patients = ITT population|||percent of participants||95% Confidence Interval|Number
1407597|NCT01197755|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 24. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
1407598|NCT01197755|Secondary|Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407599|NCT01197755|Secondary|Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407600|NCT01197755|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407601|NCT01197755|Primary|Proportion of Patients Achieving ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once daily.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407602|NCT01197612|Secondary|Sinonasal Health|Assessed with Perioperative Sinus Endoscopy (POSE) score|24 weeks post operation|Of six participants at 24 weeks, one's data was unable to be unblinded accurately, leaving an analysis population of 5 participants|||units on a scale||Full Range|Mean
1407603|NCT01197612|Secondary|Olfaction|Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification|24 weeks post operation|Of six participants remaining at 24 weeks, one participant's data could not be accurately unblinded leaving analysis of 5|||units on a scale||Full Range|Mean
1407604|NCT01197612|Secondary|Sinonasal Health|will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.|3 weeks post operation|unblinding could not be done on one person accurately, so only 15 rather than 16 people's data could be analyzed|||units on a scale||Full Range|Mean
1407605|NCT01197612|Primary|Olfaction|will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification|3 weeks post-operation|Of sixteen participants at the three week mark, one participant's data was unable to be unblinded accurately, and one participant had no UPSIT scores taken, leaving an analysis population of 14,|||units on a scale||Full Range|Mean
1407606|NCT01197573|Secondary|Number of Participants With Liver Ischemic-Type Biliary Strictures||1 year||||Participants|||Count of Participants
1407607|NCT01197573|Primary|Number of Participants With Primary Liver Graft Nonfunction||1 month||||Participants|||Count of Participants
1407608|NCT01197573|Primary|Delayed Kidney Graft Function||3 months||||Participants|||Count of Participants
1407609|NCT01197560|Secondary|Stage 2: Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) Patients|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) is a 30-item oncology-specific questionnaire developed to assess the quality of life of cancer patients. The descriptive system EQ-5D is a generic questionnaire consisting of 3 levels within each of the 5 domains. It’s is a standardized instrument for use as a measure of health outcome and provides a simple descriptive profile and a single index value for health status||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407610|NCT01197560|Secondary|Stage 2: Time to Progression for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Time to progression is defined as the time from the start of study drug therapy to the first documentation of disease progression||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407621|NCT01197547|Primary|Burn Rate||Day 1||||participants|||Number
1407611|NCT01197560|Secondary|Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Patients With a Duration of Response Lasting ≥ 16 Weeks|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).~Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.~CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.~Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407612|NCT01197560|Secondary|Stage 2: Duration of Complete Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Duration of Complete Response was to be calculated for complete responders as the time of from documented initial complete response (either CR or CRu) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407613|NCT01197560|Secondary|Stage 2: Overall Survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Overall Survival (OS) is defined as the time from randomization until death due to any cause.||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407614|NCT01197560|Secondary|Stage 2: Duration of Overall Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) was to be calculated for responders as the time from documented initial response (either CR, CRu, or PR) until documented disease progression determined by CT or MRI scan, or death, whichever occurs earlier.|Approximately 3.5 years|According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407615|NCT01197560|Secondary|Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL (Cheson1999) as evaluated by the Independent Response Assessment Committee (IRAC).~Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.~CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.~Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407616|NCT01197560|Secondary|Stage 2: Complete Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|"Complete Response Rate (CR + CRu rate) was to be calculated as the proportion of participants achieving a CR or CRu using 1999 IWG Response Criteria, (Cheson, 1999).~CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.~Cru: Criteria for CR above but with 1 or more of the following:~A residual lymph node mass > 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia)."||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407617|NCT01197560|Primary|Stage 2: Progression-free Survival for Diffuse Large B-Cell Lymphoma (DLBCL) Participants|Number of participants who survive without progressing based on the International Working Group Response Criteria [IWG].||According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre-specified requirement to be further studied in Stage 2. Study terminated after Stage 1 completed and before Stage 2 started.||||||
1407618|NCT01197560|Primary|Stage 1: Percentage of Participants With an Overall Response Rate (ORR) According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999.|"Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on IWG 1999 Response Criteria for NHL as evaluated by the Independent Response Adjudication Committee (IRAC).~Complete Response (CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers.~CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM.~Partial Response (PR) is a 50% decrease in the sum of the products of diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes"|From Sept 2010 to the data cut-off of 4 July 2013; when all participants had reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment). Median follow-up time was 6.7 and 4.7 months in each arm respectively|The Modified Intent to Treat (mITT ) population was defined as all participants randomized who had a DLBCL diagnosis and either Germinal Center B-cell subtype (GCB) or non-GCB subtype confirmed by Central Pathology, and who received at least one dose of study drug (lenalidomide or Investigator’s choice).|||percentage of participants||95% Confidence Interval|Number
1407622|NCT01197534|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1407623|NCT01197534|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease modifying antirheumatic drugs, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1407624|NCT01197534|Secondary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo|mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.|Baseline and 24 weeks|The full analysis set includes patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. Measurements at 2 timepoints are required for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.|||Units on a scale||Standard Deviation|Mean
1407625|NCT01197534|Secondary|HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. The HAQ-DI response is a reduction from baseline in HAQ-DI score greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407626|NCT01197534|Secondary|Proportion of Patients Achieving DAS28 EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407627|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR=odds ratio, PO = orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407628|NCT01197534|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407676|NCT01197417|Secondary|Warm Sensation Associated With Study Drug Infusion|Patient spontaneously reported feelings of warmth during any study drug infusion.|Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug.|||Participant|||Number
1410445|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1407629|NCT01197534|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient’s own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID = twice daily, CI = confidence interval, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day. Mean refers to change at Week 24.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
1407630|NCT01197534|Secondary|Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407631|NCT01197534|Secondary|Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407632|NCT01197534|Secondary|Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407633|NCT01197534|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient’s own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407634|NCT01197521|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle|||Units on a scale||Standard Deviation|Mean
1407635|NCT01197521|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24|SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle|||Units on a scale||Standard Deviation|Mean
1407636|NCT01197521|Secondary|HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24|HAQ-DI: Health Assessment Questionnaire – Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1448796|NCT00859469|Secondary|Overall Survival||50 months|ITT|||months||95% Confidence Interval|Median
1407637|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24|Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407638|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407639|NCT01197521|Secondary|Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407640|NCT01197521|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 24|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
1407641|NCT01197521|Secondary|Proportion of Patients Achieving ACR70 up to Week 24|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407642|NCT01197521|Secondary|Proportion of Patients Achieving ACR50 up to Week 24|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407643|NCT01197521|Secondary|ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407644|NCT01197521|Primary|Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.|mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.|Baseline and 24 weeks|The full analysis set includes those patients who received at least 1 dose of IP. Patients were analysed by randomised treatment. Measurements at 2 timepoints are required in order for a patient to be included in the analysis; therefore patients with only 1 result have been excluded from the analysis population.|||Units on a scale||Standard Deviation|Mean
1407677|NCT01197417|Secondary|Hypotension Associated With Infusion|For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.|Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment|All participants who received at least one dose of study drug|||Participant|||Number
1407645|NCT01197521|Primary|Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.|24 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
1407646|NCT01197508|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407647|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407648|NCT01197508|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking. Higher scores are indicative of greater enjoyment or satisfaction in each domain.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407649|NCT01197508|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407650|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407651|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407652|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407678|NCT01197417|Secondary|Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization||Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment|All participants who received at least one dose of study drug and who did not withdraw from data collection prior to either hospital discharge or 12 hours after last intravenous opioid.|||mg Morphine/kg||Inter-Quartile Range|Median
1407653|NCT01197508|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407654|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407655|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407656|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407657|NCT01197508|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407658|NCT01197508|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)||||units on a scale||Standard Error|Least Squares Mean
1407659|NCT01197508|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1407660|NCT01197508|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407661|NCT01197508|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407662|NCT01197508|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1419031|NCT01107197|Secondary|Rate of Healing|complete healing|8 weeks of nutritional support (baseline and week 8)||||participants|||Number
1407663|NCT01197508|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
1407664|NCT01197508|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1407665|NCT01197508|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1407666|NCT01197508|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1407667|NCT01197508|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1407668|NCT01197495|Secondary|Duration Effect of Treatment on Lip Fullness|Duration of treatment effect on lip fullness is assessed by the blinded Evaluating Investigator as ≥1-point Improvement from baseline in overall lip fullness of the eligible lip at each visit.|Month 1, Month 3, Month 6, Month 7.5, Month 9, Month 10.5, Month 12|Modified Intent-to-Treat: all treated subjects with data at the designated time point|||% of Pts Retaining ≥1-point Improvement||95% Confidence Interval|Number
1407669|NCT01197495|Secondary|Percentage of Subjects Achieving Their Personal Treatment Goal of Overall Lip Fullness|Subjects assessed their personal treatment goal of overall lip fullness as 'achieved' or 'not achieved.'|Baseline, Month 3|Treated subjects in the Treatment group|||Percentage of Subjects|||Number
1407670|NCT01197495|Secondary|Percentage of Oral Commissures With ≥1-Point Improvement on the Oral Commissures Severity (OCS) Scale|Subject's right and left oral commissures are assessed compared to baseline using the validated OCS Scale. Scores range from 0=none (best) to 3=severe (worst).|Baseline, Month 3|Subjects treated for OCS at the designated time points|||Percentage of Oral Commissures|Participants||Number
1407671|NCT01197495|Secondary|Percentage of Subjects With ≥1-Point Improvement on the Perioral Line (POL) Severity Scale|Subject's upper lip perioral lines are assessed compared to baseline using the 4-point validated POL Severity Scale. Scores range from 0=None (best) to 3=Severe (worst).|Baseline, Month 3|Subjects treated for POL at the designated time points|||Percentage of Subjects|||Number
1407672|NCT01197495|Primary|Percentage of Subjects With ≥1-Point Improvement on the Investigator Assessed 5-point Lip Fullness Scale 2 (LFS2)|Overall lip fullness is assessed by the blinded Evaluating Investigator compared to baseline using the 5-point LFS2. Scores range from 1=minimal improvement to 5=very marked improvement.|Baseline, Month 3|Modified Intent-to-Treat: all treated subjects with data at the designated time point|||Percentage of Subjects||95% Confidence Interval|Number
1407673|NCT01197417|Secondary|Hospital Length of Stay||Start of first study drug infusion to actual hospital discharge||||Hours||Inter-Quartile Range|Median
1407674|NCT01197417|Secondary|Development of Acute Chest Syndrome (ACS)||Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment||||Paricipants|||Number
1407675|NCT01197417|Secondary|Rehospitalization||Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)|All participants who received at least one dose of study drug who had known rehospitalization status within 7 days|||Participant|||Number
1407680|NCT01197378|Secondary|White Blood Cell Cystine Concentration|White blood cell (WBC) cystine concentration was determined using high performance liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS).|Day 1 (predose) and Month 6, Years 1, 1.5, 2, 3, 4 and 5 at 0.5 hours post-dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Population includes all participants who had at least one PK/PD measurement. Day 1 results only include participants who did not complete Study RP103-03.|||nmol 1/2 Cystine/mg protein||Standard Deviation|Mean
1407681|NCT01197378|Secondary|Trough Plasma Cysteamine Concentration|Plasma cysteamine concentration was determined using methods employing Hydrophilic Interaction Liquid Chromatography (HILC) high pressure liquid chromatography (HPLC) tandem mass spectrometry (HPLC-MS/MS).|Day 1 (predose) and Month 6, Years 1, 1.5, 2, 3, 4 and 5 at 0.5 hours post-dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Population includes all participants who had at least one PK/PD measurement. Day 1 results only include participants who did not complete Study RP103-03.|||mg/L||Standard Deviation|Mean
1407682|NCT01197378|Primary|Number of Participants With Treatment-emergent Adverse Events|"Drug-related adverse events (AEs) are AEs the investigator assessed as having relation to drug of 'possibly', 'probably' or 'definitely'.~The severity of AEs was categorized according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 as follows:~Mild (Grade 1): experience is minor and does not cause significant discomfort to subject or change in activities of daily living (ADL); subject is aware of symptoms but symptoms are easily tolerated;~Moderate (Grade 2): experience is an inconvenience or concern to the subject and causes interference with ADL, but the subject is able to continue with ADL.~Severe (Grade 3): experience significantly interferes with ADL and the subject is incapacitated and/or unable to continue with ADL~Life-threatening (Grade 4): experience that, in the view of the Investigator, places the subject at immediate risk of death from the event as it occurred."|From first dose of study drug to 7 days after the last dose; median duration of treatment was 1461 days.|All participants who received at least 1 dose of cysteamine bitartrate.|||Participants|||Count of Participants
1407683|NCT01197326|Secondary|Respiration Rate Impact on RRT Calls|Proportion of calls secondary to abnormal respiratory vital signs. Respiration Rate is considered to be one of the main early indicators of deterioration.|6 months||||percentage of calls|||Number
1407684|NCT01197326|Primary|Survival|Survival at the end of the RRT call (time when the RRT team left the patient, average duration of calls around 25 min)|6 months||||percentage of participants|||Number
1407685|NCT01196988|Secondary|Number of Days With Solicited General Symptoms|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)].|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||days||Inter-Quartile Range|Median
1407686|NCT01196988|Secondary|Number of Days With Solicited Local Symptoms.|The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.|During the 7-day (Days 0-6) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||days||Inter-Quartile Range|Median
1407687|NCT01196988|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.|||subjects|||Number
1407688|NCT01196988|Secondary|Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results|||subjects|||Number
1407689|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.|||subjects|||Number
1407690|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.|During the 28-day (Days 0-27) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.|||subjects|||Number
1407691|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||subjects|||Number
1407692|NCT01196988|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.|||subjects|||Number
1407693|NCT01196988|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child <6 years) or pain that prevented normal activity (Child >6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.|During the 7-day (Days 0-6) follow-up period after any vaccination.|The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom completed.|||subjects|||Number
1407694|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1407695|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1407696|NCT01196988|Secondary|Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1407697|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407698|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407699|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1408211|NCT01193608|Other Pre-specified|Change From Baseline in CSF Tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
1407700|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407701|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407702|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407703|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407704|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407705|NCT01196988|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407706|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407707|NCT01196988|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1408212|NCT01193608|Other Pre-specified|CSF Amyloid-beta x-42 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
1407708|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).~Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1407709|NCT01196988|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.|"Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).~Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years."|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1407710|NCT01196988|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1407711|NCT01196988|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1407712|NCT01196975|Secondary|Number of Days With Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity. Analyses of duration for unsolicited AEs were not performed.|Within the 21-day (Days 0-20) follow-up period post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.||||||
1407713|NCT01196975|Secondary|Number of Days With Solicited General Symptoms After Vaccination|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr.), headache, muscle ache, shivering, temperature (defined as oral temperature equal to or above 38.0 degrees Celsius) and joint pain at location other than the injection site (Joint Pain). Joint pain data were collected for subjects in Canada and Mexico only. Analyses of duration for solicited general symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||||||
1407714|NCT01196975|Secondary|Number of Days With Solicited Local Symptoms After Vaccination.|Solicited local symptoms were pain, redness and swelling at the injection site. Analyses of duration for solicited local symptoms were not performed.|Within the 7-day follow-up period after vaccination (Days 0-6)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.||||||
1407715|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination.|Within the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1407716|NCT01196975|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastr. Symptoms), headache, muscle ache, shivering, temperature – oral temperature equal to or above (≥) 38.0 degrees Celsius (°C) - and joint pain at location other than the injection site (Joint Pain). Grade 3 temperature = temperature ≥ 39.0 °C. Grade 3 symptom = symptom that prevented normal everyday activity. Related symptom = symptom assessed by the investigator as causally related to study vaccination. Joint pain data were collected for subjects in Canada and Mexico only.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||Subject|||Number
1407791|NCT01196104|Secondary|Severe Hypoglycemic Event Rate|"Severe hypoglycemic event rate, ie, total number of events divided by subject-months of observation~Severe hypoglycemia is defined as a subject who requires the assistance of another individual (not merely requested) and either:~SMBG levels ≤ 36 mg/dL OR~There is a prompt response to the administration of carbohydrate, glucagon, or other resuscitative measures"|Baseline to Week 16|Safety Population|||Events / subject-month|||Number
1407717|NCT01196975|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Grade 3 pain = significant pain at rest/pain that prevented normal everyday activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) follow-up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, on subjects for whom results were available.|||Subject|||Number
1407718|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1407719|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1407720|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subject|||Number
1407721|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subject|||Number
1407722|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.|||Titer||95% Confidence Interval|Geometric Mean
1407723|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1407724|NCT01196975|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Results for Day 21 for the subjects in the GSK2282512A Group are the results specific to this primary outcome measure.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1407792|NCT01196104|Secondary|Total Number of Cough Episodes|Total number of times patients coughed once, intermittently or continuously (inclusive)|Baseline to Week 16|Safety Population|||Cough episodes|||Number
1407793|NCT01196104|Secondary|Treatment Satisfaction as Assessed by Subject Treatment and Health Outcomes Questionnaires|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1407725|NCT01196975|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the Day 21 reciprocal HI titer to the Day 0 reciprocal HI titer). The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1407726|NCT01196975|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subject|||Number
1407727|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subject|||Number
1407728|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subject|||Number
1407729|NCT01196975|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N1), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 (FLO) flu strains|At Day 0 (D0) and at Day 21 (D21) after vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||Subject|||Number
1407730|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol, and with available assay results at Day 180 for assessed antibodies.|||Titer||95% Confidence Interval|Geometric Mean
1407731|NCT01196975|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subject|||Number
1407732|NCT01196975|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator to be causally related to vaccination.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.|||Subject|||Number
1407733|NCT01196975|Secondary|Number of Subjects With Related Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE. Related MAE = MAE assessed by the investigator to be causally related to vaccination. Relationship to vaccination was not computed for MAEs.|From the beginning of the study until study end (from Day 0 to Day 180) .|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.||||||
1407794|NCT01196104|Secondary|Changes in Body Weight at 16 Weeks|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1407734|NCT01196975|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other serious adverse event [SAE] criterion), it was reported as SAE.|From the beginning of the study until study end (from Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, on subjects with available results.|||Subject|||Number
1407735|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-60Y and ≥ 61Y.|At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all vaccinated subjects who had not received a vaccine forbidden in the protocol with available assay results for assessed antibodies in Day 180 blood samples.|||titer||95% Confidence Interval|Geometric Mean
1407736|NCT01196975|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. Antibodies assessed were antibodies against the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (BRI) and FLU B/Florida/4/06 flu strains. Subjects were assessed according to 2 age categories, 18-64Y and ≥ 65Y.|At Day 0 (D0) and at Day 21 (D21) post vaccination.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1407737|NCT01196923|Primary|Acute Isolation of Pulmonary Veins.|99% of pulmonary veins were isolated (72/73)|Acute PVI measured on the day of treatment|All treated participants with reported data.|||percent isolated pulmonary veins|||Number
1407738|NCT01196819|Secondary|the Incidence of Stent Thrombsis (ARC Defined)||5 years after index PCI||||Participants|||Count of Participants
1407739|NCT01196819|Secondary|the Incidence of Stent Thrombsis (ARC Defined)||3 years after index PCI||||Participants|||Count of Participants
1407740|NCT01196819|Secondary|the Incidence of Stent Thrombsis (ARC Defined)||1 years after index PCI||||Participants|||Count of Participants
1407741|NCT01196819|Secondary|TLF(Target Lumen Failure)|TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.|5 years after index PCI||||participants|||Number
1407742|NCT01196819|Secondary|TLF(Target Lumen Failure)|TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.|3 years after index PCI||||participants|||Number
1407743|NCT01196819|Secondary|TLF(Target Lumen Failure)|TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.|1 years after index PCI||||participants|||Number
1407744|NCT01196819|Secondary|9 Months In-stent Percent Diameter Stenosis|the in-stent percent diameter stenosis 9 months after the surgery|9 months||||percentage of diameter stenosis||Standard Deviation|Mean
1407745|NCT01196819|Primary|9 Months In-stent Late Lumen Loss|To observe in-stent late lumen loss after 9 months of stent implantation It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure|9 months||||mm||Standard Deviation|Mean
1407746|NCT01196741|Secondary|Median PFS||From first saracatinib/placebo dose to first documented progression and/or death, assessed up to 36 months||||months||95% Confidence Interval|Median
1407747|NCT01196741|Secondary|Median Time To Progression Based on RECIST v1.1 and GCIG CA125 Criteria|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~Time To Progression will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||||||
1407748|NCT01196741|Secondary|Quality of Life: Trial Outcome Index (TOI) Based on FACT-O|"The TOI value for each patient is derived at each timepoint by calculating the sum of 3 subscales: Physical Well-Being (PWB), Functional Well-Being (FWB), Additional Concerns. Each subscale score is derived from questions with 4 answers (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). In each subscale reversals are performed and the individual question scores added together. This value is then multiplied by the number of questions within the subscale, and divided by the number of questions answered to derive a subscale score. The higher each subscale score, the better the QoL.~PWB 7 questions, lower values=better QoL.~FWB 7 questions, higher values=better QoL.~Additional concerns 11 questions (higher values in 6 questions=better QoL; higher values in 5 questions=worse QoL)~The TOI is reported for each arm based on the average TOI score of each patient calculated across the outcome measure time frame. The higher the TOI, the better the QoL."|Patients will fill in FACT-O questionnaires at the following timepoints: baseline; Weeks 1, 3 and 6 of every chemotherapy cycle; at every follow up visit||||units on a scale||Standard Error|Mean
1407749|NCT01196741|Secondary|Median Duration of Response|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~Duration of Response will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.|||||||
1407750|NCT01196741|Secondary|Objective Response Rate Based on Investigator Assessment Based on RECIST v1.1 +/- GCIG CA125 Criteria|Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||percentage of participants|||Number
1407751|NCT01196741|Secondary|Overall Survival||First saracatinib/placebo dose until death, assessed up to 36 months||||months||Full Range|Median
1407752|NCT01196741|Primary|6 Month Progression-free Survival Rate (PFS) (Based on Combined Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 +/- Gynecologic Cancer Intergroup (GCIG) CA125 Criteria)|"Where a patient's disease is not measurable by RECIST v1.1, response may be based on GCIG CA125 criteria plus symptoms.~The 6 month progression-free survival rate will be calculated by the trial statistician during the final analysis."|Using RECIST v1.1 at baseline; at Week 7 or 8 of each chemotherapy cycle; and 3 monthly during follow up. CA125 response will be assessed at baseline, weeks 1, 3 and 6 of each chemotherapy cycle, and at every follow up visit.||||percentage of participants||90% Confidence Interval|Number
1407753|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 3|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Month 3||||units on a scale||Standard Error|Least Squares Mean
1407754|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy n Other Non-pain Symptoms at Month 2|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 2||||units on a scale||Standard Error|Least Squares Mean
1407755|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Month 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|month 1||||units on a scale||Standard Error|Least Squares Mean
1407756|NCT01196442|Secondary|Effect of Electric Stimulation Pain Therapy on Other Non-pain Symptoms at Day 10|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 10||||units on a scale||Standard Error|Least Squares Mean
1407757|NCT01196442|Secondary|Use of Medications Including Morphine Oral Dose Equivalents, Anti-depressants, and Neuroleptics|Record daily pain medication usage and convert all opioids to MOEDs (American Pain Society 2003). Compare the average daily use prior to day 1 to the average daily use day 30. Range is 0-none to 240-most|From day 1 to day 30||||doses||Standard Deviation|Mean
1407758|NCT01196442|Secondary|Effect of Electrical Stimulation Pain Therapy on Other Non-pain Symptoms at Day 1|Chemotherapy-induced peripheral neuropathy (CIPN)-20. The CIPN-20 has 3 subscales: a sensory, motor, and autonomic subscale. There are 17 questions that are rated 0-not at all to 3-very much. Scales are summed. Final score ranges from 0-51, 0 as the best possible outcome and 51 as the worst.|Day 1|Participants at Day 1|||units on a scale||Standard Error|Least Squares Mean
1407759|NCT01196442|Primary|Change in Pain Score From Day 1 to Day 10|"Change in Brief Pain Inventory (Now)Scale~1 (none) to 5 (complete interference)"|From day 1 to day 10||||units on a scale||Standard Deviation|Mean
1407760|NCT01196429|Secondary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. RECIST1.1 is a multi-page paper, and response is defined in the protocol across multiple pages, so it is not practical to define response here.|Every other cycle for first 6 months; then every 3 months for two years; then every six months for the next three years; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tu|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1407761|NCT01196429|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and Treated Patients|||months||90% Confidence Interval|Median
1407762|NCT01196429|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1|Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 mths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising tumor mark|Eligible and Treated Patients|||months||90% Confidence Interval|Median
1407763|NCT01196429|Primary|Frequency and Severity of Toxicity|Grade 3 or higher adverse events were graded by CTC AE v4|Each cycle while on treatment|Eligible and Treated Patients|||participants|||Number
1407764|NCT01196429|Primary|Compare Progression-free Survival in Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer Patients in Patients in the U.S. and Worldwide (Outside of Japan) Versus Patients in Japan.|"Progression-free survival (PFS) was defined s the period from study entry until disease progression, death, or the last date of contact. Progression was based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Outcome measure data not reported because protocol stated If the combination is declared active (i.e. HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status. The combination was not declared active in either population."|Tumor scans were done every other cycle for the first 6 months;then every 3 mnths x2;then every 6 mnths thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggesting progressive dx or rising serum tumor marker le|"The protocol stated if the combination is declared active (i.e., HO is rejected) in one or both of the populations, the two populations will be compared with respect to PFS using a logrank test stratified by optimal/suboptimal disease status. The combination was not declared active in either population."||||||
1407795|NCT01196104|Secondary|Glycemic Excursions and Variability as Assessed Through Continuous Glucose Monitoring (CGM)|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1407796|NCT01196104|Secondary|Seven-point Glucose at Randomization and Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1407797|NCT01196104|Secondary|Glycomark and Fructosamine Levels Measured Throughout the Study|Not analyzed due to early termination of the trial.|Change from baseline to 16 weeks|||||||
1407765|NCT01196429|Primary|Proportion of Patients Who Are Alive and Progression-free for at Least 12 Months After Study Entry in Patients With Newly Diagnosed Stage III or IV Clear Cell Ovarian Cancer in the Following Populations: Patients in the U.S./Worldwide and Japan|Progression of target lesions (TL) was a >=20% increase in the sum of the diameters of TL, taking as reference the smallest sum on study (including the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must demonstrate an absolute increase >=5 mm. Progression of non-target lesions (NTL) as defined as appearance of >=1 new lesions or unequivocal progression of existing NTL. Unequivocal progression should not normally trump target lesion status; it must be representative of overall disease status change, not a single lesion increase. Clear progression of only NTL is exceptional, but the opinion of the treating physician should prevail in such circumstances, and the progression status should be later confirmed by a review panel (or Principal Investigator). Progression of TL, unequivocal progression of NTL, or new lesions constitutes progression. This description is abbreviated; see the RECIST 1.1 manuscript for further details.|Tumor scans were done every other cycle for the first 6 months; then every 3 months x2; then every 6 months thereafter; and at any other time if clinically indicated or signs suggestive of progressive disease or rising levels; for up to 5 years.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1407766|NCT01196416|Secondary|Toxicity as Assessed by NCI CTCAE v. 4.0|Reported by type, frequency and severity.- Please see adverse events section.|Up to 30 days post-treatment|||||||
1407767|NCT01196416|Secondary|Progression-free Survival (Phase II)|Progression-free survival curves will be generated using Kaplan-Meier methodology.|Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years|||||||
1407768|NCT01196416|Secondary|Presence or Absence of Markers of Pathway Inhibition in Patient Tumors (Phase Ib)|The association of response or clinical benefit with the presence or absence of markers of pathway inhibition in patient tumors will be tested using Fisher's exact test.|2 weeks|||||||
1407769|NCT01196416|Secondary|Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB)||At baseline, and at days 1, 2, and 3 of courses 1 and 2|||||||
1407770|NCT01196416|Secondary|Change in Protein Levels by Immunohistochemistry (Phase Ib)|"Pre and post-treatment protein levels will be compared by Wilcoxon signed-rank test (for paired samples).~Data is not yet available, as it's currently being analyzed."|Baseline up to 2 weeks|||||||
1407771|NCT01196416|Primary|Maximum Tolerated Dose for RO4929097|based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB)|21 days||||mg/day|||Number
1407772|NCT01196416|Primary|Overall Survival (Phase II)|Overall response rate (complete [CR] or partial response [PR]) according to RECIST version 1.1|Up to 2 years||||participants|||Number
1407773|NCT01196416|Primary|Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ|"based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB)~Data is not yet available, as it's currently being analyzed."|21 days||||mg/m2|||Number
1407774|NCT01196416|Primary|Overall Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years||||Participants|||Count of Participants
1407775|NCT01196377|Primary|%FEV1|% predicted forced expiratory volume in 1-second as a measure of airway obstruction|2 hours||||%-predicted||Full Range|Mean
1407776|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FVC|Baseline to Week 20|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
1407777|NCT01196104|Secondary|Week 20 (Follow-up) Forced Vital Capacity|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) FVC|Week 20|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
1407778|NCT01196104|Secondary|Week 16 Change From Baseline Forced Vital Capacity|Week 16 Change from Baseline FVC|Baseline to Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
1407779|NCT01196104|Secondary|Week 16 Forced Vital Capacity|Week 16 FVC|Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
1407780|NCT01196104|Secondary|Baseline Forced Vital Capacity (FVC)|Baseline FVC|Baseline|Safety Population|||L||Standard Deviation|Mean
1407781|NCT01196104|Secondary|Week 20 (Follow-up) Change From Baseline in Forced Expiratory Volume in 1 Second|Week 20 (Follow-up, 4 weeks after discontinuation of study treatment) Change from Baseline in FEV1|Baseline to Week 20|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
1407782|NCT01196104|Secondary|Week 20 (Follow-up) Forced Expiratory Volume in 1 Second|Week 20 (Follow-up) FEV1, 4 weeks after discontinuation of study treatment|Week 20 (Follow-up)|Safety Population, with data available at Week 20|||L||Standard Deviation|Mean
1407783|NCT01196104|Secondary|Week 16 Change From Baseline in Forced Expiratory Volume in 1 Second|Week 16 Change from Baseline in FEV1|Baseline to Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
1407784|NCT01196104|Secondary|Week 16 Forced Expiratory Volume in 1 Second|Week 16 FEV1|Week 16|Safety Population, with data available at Week 16|||L||Standard Deviation|Mean
1407785|NCT01196104|Secondary|Baseline Forced Expiratory Volume in 1 Second (FEV1)|Baseline FEV1|Baseline|Safety Population|||L||Standard Deviation|Mean
1407786|NCT01196104|Secondary|Number of Cough Episodes Occuring Within 10 Minutes of Drug Inhalation||Baseline to Week 16|Safety Population|||Cough episodes|||Number
1407787|NCT01196104|Secondary|Number of Single Coughing Episodes|Total number of times patients coughed only once|Baseline to Week 16|Safety Population|||Cough episodes|||Number
1419032|NCT01107197|Secondary|Rate of Healing|reduction in ulcer area >=40%|8 weeks of nutritional support (baseline and week 8)||||participants|||Number
1407802|NCT01196091|Secondary|Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline|"The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks.~The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology."|Baseline through 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.|||Participants|||Count of Participants
1407803|NCT01196091|Secondary|Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score)~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of participants|||Number
1407804|NCT01196091|Secondary|Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score|Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
1407805|NCT01196091|Secondary|Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks|An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.|52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of participants|||Number
1407806|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint in PGA|Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||millimeters||Standard Deviation|Mean
1407807|NCT01196091|Secondary|Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares|"The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare.~Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit."|Baseline through 52 weeks|Zero participants analyzed. Time first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares data was not collected for analysis.||||||
1407808|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores|The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and a non-missing result.|||units on a scale||Standard Deviation|Mean
1407809|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores|A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
1407810|NCT01196091|Secondary|Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks|Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening is defined as increase of ≥0.3 points.|52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues|||percentage of participants|||Number
1408213|NCT01193608|Other Pre-specified|Change From Baseline in CSF Amyloid-beta x-42 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
1407811|NCT01196091|Secondary|Time to First Severe SLE Flare (SFI)|"The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity.~Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1)."|Baseline through 52 weeks|Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis.||||||
1407812|NCT01196091|Secondary|Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score|SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period.|||units on a scale||Standard Deviation|Mean
1407813|NCT01196091|Secondary|Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.|Baseline, 52 weeks|All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues and a non-missing result at Week 52.|||international units||Standard Deviation|Mean
1407814|NCT01196091|Secondary|Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52|A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.|52 weeks|All randomized participants who received at least 1 dose of study drug, a baseline use of prednisone or equivalent >7.5 mg/day, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of partipants|||Number
1407815|NCT01196091|Primary|Percentage of Participants Achieving an SLE Responder Index Response at Week 52|"Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.~SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data."|52 weeks|Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug and evaluable SLE scores, excluding two sites' participants due to good clinical practice (GCP) issues.|||percentage of participants|||Number
1407816|NCT01196078|Secondary|Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1407817|NCT01196078|Secondary|Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire|The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1407818|NCT01196078|Secondary|Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change|The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.|Baseline and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1407840|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.|||days||Inter-Quartile Range|Median
1407819|NCT01196078|Secondary|Changes in Quality of Life as Measured by the FACT Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1407820|NCT01196078|Secondary|Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire|The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.|Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1407821|NCT01196078|Secondary|Overall Survival: Time to Event|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population|||months||95% Confidence Interval|Median
1407822|NCT01196078|Secondary|Overall Survival: Percentage of Participants With an Progressive Disease or Death|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment|ITT population|||percentage of participants|||Number
1407823|NCT01196078|Secondary|Time to Disease Progression|Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population|||months||95% Confidence Interval|Median
1407824|NCT01196078|Secondary|Percentage of Participants With Disease Progression|Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death|ITT population|||percentage of participants|||Number
1407825|NCT01196078|Secondary|Duration of Response Among Participants Who Achieved Either a CR or PR|Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.|Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up|ITT population; only participants with a response (CR or PR) were included in the analysis.|||months||95% Confidence Interval|Median
1407826|NCT01196078|Secondary|Percentage of Participants Achieving Disease Control|Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT Population|||percentage of participants|||Number
1407827|NCT01196078|Primary|Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)|CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.|Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year|ITT population|||percentage of participants|||Number
1407828|NCT01196052|Secondary|Disease-free Survival at Month 12|Disease-free survival was defined as the time from date of first protocol treatment for adjuvant patients or date of surgery for neoadjuvant patients to disease recurrence, occurrence of invasive contralateral breast cancer, other second primary cancer (excluding non-breast second primary), or death, whichever occurred first.|From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later|"Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.~Due to too few events, the analysis of disease-free survival was not performed."||||||
1408535|NCT01192282|Primary|Number of HPV Genotypes Isolated by HIV Status|Number of HPV Genotypes isolated according to HIV Status|Up to 18 months|119 out of 126 uncontaminated samples were HPV DNA Positive. Out of these 119 HPV DNA Positive Samples, 12 were B-Globin Positive but no specific HPV Genotype could be identifiable.|||participants|||Number
1407829|NCT01196052|Secondary|Percentage of Participants With a Pathological Complete Response|Pathological complete response was defined as the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes after surgery following primary systemic therapy. Pathological complete response was evaluated in participants treated with neoadjuvant therapy doxorubicin/cyclophosphamide-5-fluorouracil/epirubicin/cyclophosphamide followed by 1 or more doses of trastuzumab emtansine and who underwent surgery.|Day of surgery|Efficacy analysis population: All participants who enrolled in the neoadjuvant setting and received surgery, after completing 4 cycles of trastuzumab emtansine treatment.|||Percentage of participants||95% Confidence Interval|Number
1407830|NCT01196052|Secondary|Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay||From the start to the end of radiotherapy treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy and who had radiotherapy dose information reported were included in the analysis.|||Percentage of participants|||Number
1407831|NCT01196052|Secondary|Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment|Participants were to receive up to a total of 17 cycles of trastuzumab emtansine. If trastuzumab was given concurrently with either the optional docetaxel or optional radiation, then the number of 3-week cycles of trastuzumab therapy was subtracted from the planned 17 cycles of trastuzumab emtansine therapy.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.|||Percentage of participants|||Number
1407832|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent hormonal therapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent hormonal therapy were included in the analysis.|||Percentage of participants|||Number
1407833|NCT01196052|Secondary|Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment||From the start to the end of concurrent radiotherapy (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine. Only participants who received concurrent radiotherapy were included in the analysis.|||Percentage of participants|||Number
1407834|NCT01196052|Primary|Adverse Events, LVEF Function, and Deaths|The following percentages of participants are reported: At least 1 adverse event while receiving T-DM1; at least 1 serious adverse event while receiving T-DM1; an adverse event leading to discontinuation, dose delay, or dose reduction of trastuzumab emtansine treatment; symptomatic cardiac dysfunction; and asymptomatic decline in left ventricular ejection fraction (LVEF). An asymptomatic LVEF decline was defined as a LVEF < 50% and a maximum decrease ≥ 10% from Baseline. The percentage of participants who died is reported.|From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab emtansine.|||Percentage of participants|||Number
1407835|NCT01196052|Primary|Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment|A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association [NYHA] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of < 50%.|Baseline to 12 weeks after the start of trastuzumab emtansine treatment|Cardiac-safety evaluable population: All participants who received at least 1 dose of T-DM1 and met either of the following 2 criteria: (1) Had an echocardiogram/multiple-gated acquisition assessment by 12 weeks after the first dose of T-DM1 or (2) discontinued study treatment because of cardiac toxicity prior to completion of 4 cycles of T-DM1.|||Percentage of participants||95% Confidence Interval|Number
1407836|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Month 6|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||subjects|||Number
1407837|NCT01196026|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Up to Day 28|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||subjects|||Number
1407838|NCT01196026|Secondary|Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest|"MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.~AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis."|During the entire study period (up to Month 6)|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||subjects|||Number
1407839|NCT01196026|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any was defined as any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Day 0-27) after vaccination|The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.|||subjects|||Number
1407978|NCT01195415|Primary|Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS|The median percentage of CD44+CD24+ESA+ cells from needle biopsy were calculated at baseline and at 3 weeks using FACS. The difference between the two time points was calculated.|3 weeks|Of the 25 patients enrolled, only 22 were evaluable for the primary endpoint.|||percentage of CD44+/ CD24+/ ESA+ cells||Full Range|Median
1407841|NCT01196026|Secondary|Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.|||subjects|||Number
1407842|NCT01196026|Secondary|Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old|Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.|During a 7-day follow-up period (Day 0-6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.|||days||Inter-Quartile Range|Median
1407843|NCT01196026|Secondary|Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0–6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.|||subjects|||Number
1407844|NCT01196026|Secondary|Duration of Any Solicited Local Symptom|Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.|During the 7 days (Days 0 – 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.|||days||Inter-Quartile Range|Median
1407845|NCT01196026|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.|During the 7 days (Day 0 – 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.|||subjects|||Number
1407846|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||subjects|||Number
1407847|NCT01196026|Secondary|Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix|Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||subjects|||Number
1407848|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||subjects|||Number
1407849|NCT01196026|Secondary|Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:28.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||subjects|||Number
1407850|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs.] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||titer||95% Confidence Interval|Geometric Mean
1407851|NCT01196026|Secondary|Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as Geometric Mean Titers (GMTs).|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||titer||90% Confidence Interval|Geometric Mean
1407852|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||ratio||95% Confidence Interval|Geometric Mean
1407853|NCT01196026|Secondary|Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||ratio||95% Confidence Interval|Geometric Mean
1407854|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||subjects|||Number
1407855|NCT01196026|Secondary|Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.|||subjects|||Number
1407856|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine."|Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||subjects|||Number
1407857|NCT01196026|Secondary|Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine|"A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains."|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.|||subjects|||Number
1407858|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||subjects|||Number
1407859|NCT01196026|Secondary|Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains|Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.|||subjects|||Number
1407860|NCT01196026|Secondary|HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.|Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.|||titer||95% Confidence Interval|Geometric Mean
1407861|NCT01196026|Secondary|HI Antibody Titers Against All Fluarix Vaccine Strains|Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.|Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.|||titer||95% Confidence Interval|Mean
1407862|NCT01196026|Primary|Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||ratio||95% Confidence Interval|Geometric Mean
1407863|NCT01196026|Primary|Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||subjects|||Number
1407864|NCT01196026|Primary|Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||subjects|||Number
1407865|NCT01196026|Primary|Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine|Seropositivity was defined as antibody titers greater than or equal to 1:10.|Day 0-28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||subjects|||Number
1407866|NCT01196026|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs).|Day 0 and 28|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.|||titer||95% Confidence Interval|Geometric Mean
1407867|NCT01195948|Secondary|Changes in High-speed Indocyanine Green Angiography (HS-ICG)||Week 24|||||||
1407868|NCT01195948|Secondary|Reduction in Exposure to Corticosteroid as Measured by the Area Under the Dose-time Curve.||Week 24|||||||
1407869|NCT01195948|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||participants|||Number
1407870|NCT01195948|Secondary|Number of Participants Presenting No Change in Retinal Vessel Leakage Observed by Fluorescein Angiography (FA) at Week 24 Compared to Baseline||Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||participants|||Number
1407871|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Left Eye (OS) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||ETDRS letters||Full Range|Mean
1407872|NCT01195948|Secondary|Mean Change in Best-Corrected Visual Acuity (BCVA) in Right Eye (OD) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||ETDRS letters||Full Range|Mean
1407873|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 52|Twenty-five (25) participants completed Week 52. Three completed prior to Week 52 as a result of early study closure (1/group), two placebo participants and one 4 mg participant were lost to follow-up at Weeks 10, 44 and 28, respectively.|||participants|||Number
1407874|NCT01195948|Secondary|Proportion of Participants Determined to be a Treatment Failure, Defined as Recurrent (or Flare) of Uveitis or a Drop in Visual Acuity of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Recurrent (or flare) of uveitis is defined as at least a 2-step increase in anterior chamber cells and/or vitreous haze using the Standardization of Uveitis Nomenclature (SUN) grading system|Week 24|Thirty (30) participants completed Week 24. One placebo participant was lost to follow-up at Week 10.|||participants|||Number
1407875|NCT01195948|Primary|The Primary Outcome is the Time to Recurrence of Uveitis in Participants of Each Treatment Group, During or After Tapering of Oral Prednisone to a Dose of 7.5 mg/Day, or Equipotent Dose of Alternative Corticosteroid Medication.|"Recurrence (or flare) is defined as an anterior chamber cells and/or vitreous haze grading of ≥ 2+ using the Standardization of Uveitis Nomenclature (SUN) grading system.~The time to this event is defined as the time from randomization to recurrence, loss to follow-up or end of study, whichever comes first. Participants that do not present with disease recurrence will be censored at the time of the last disease evaluation."|Time from randomization to recurrence, loss to follow-up, or end of study, up to 52 weeks||||weeks||Inter-Quartile Range|Median
1407876|NCT01195922|Primary|Percent (%) Change in Clinical and Laboratory Evaluations for Safety||Percent (%) change from Pre to Post treatement (~21 days)|Same sample loss during processing for phosphor and magnesium|||percentage change from baseline||Standard Deviation|Mean
1407877|NCT01195922|Primary|Percent (%) Changes in Tumor Size, Blood Flow, and Standardized Uptake Value||21 days post treatment with rapamycin|It was not possible to obtain appropriate CT scans or SUV measurement from all participants|||percentage change from baseline||Standard Deviation|Mean
1407878|NCT01195922|Primary|Percent (%) Change in Levels of pS6, pAKt473, and Ki-67||21 days post treatment with rapamycin|paraffin embedded formalin fixed tissues including head and neck cancer lesion were not available for 2 participants|||percentage of change from baseline||Standard Deviation|Mean
1407879|NCT01195883|Secondary|Acute Kidney Injury|Preoperative-to-postoperative change in AKIN stage|Hospitalization||||Participants|||Count of Participants
1407880|NCT01195883|Secondary|Major Complications, Readmission, and Death|A composite of the primary outcome, and readmission and death.|Postoperative 30 days||||Participants|||Count of Participants
1408536|NCT01192282|Primary|HPV DNA and Pap Smear Results|Relationship between HPV DNA Positivity and Pap Smear Results|18 Months|Only 118 out of 119 patients with HPV DNA Positive had a Pap Smear done. One patient was a Virgin and hence no Pap Smear was done.|||Participants|||Number
1407881|NCT01195883|Secondary|Postoperative Morbidity (Minor Complications)|Any of the following minor complications: (1) unplanned ICU admission; (2) unplanned operation; (3) cardiac (ischemia/non-ventricular arrhythmia/hemodynamic disturbances); (4) pulmonary effusion; (5) deep venous thrombosis; (6) gastrointestinal (effusion/gut paralysis); (7) progressive renal insufficiency; (8) infection (superficial/fever/cystitis or urinary tract infection); and (9) transient neurological injury.|Postoperative 30-days||||Participants|||Count of Participants
1407882|NCT01195883|Primary|Umber of Participants With Postoperative Morbidity (Major Complications)|Any of the following major complications: (1) Cardiac (Acute heart failure/Myocardial infarction/Ventricular arrhythmia); (2) pulmonary (embolism/edema/respiratory failure/pneumonia/pleural effusion); (3) gastrointestinal (bowel and surgical anastomosis stricture or anastomotic leak/internal or external fistulas/peritoneal effusions); (4) Renal (requiring dialysis); (5) Infectious (deep or organ space surgical site infection / sepsis); and (6) Coagulation (bleeding).|Postoperative 30-days||||Participants|||Count of Participants
1407883|NCT01195844|Primary|The Number of Deaths in Hospitalized Participants Enrolled in the Study|The number of deaths among children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|Participants were not followed-up in the study; thus the number of deaths was not known.||||||
1407884|NCT01195844|Primary|The Duration of Hospitalization for Participants Enrolled in the Study|The mean duration (days) of hospital stay for children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|From hospital admission to discharge|The population analyzed was all enrolled participants whether or not a fecal sample was obtained.|||days||Standard Deviation|Mean
1407885|NCT01195844|Primary|The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained|||Participants|||Number
1407886|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was reported for each age group.|1 year|The population analyzed was the 27 of 190 participants who had a fecal sample positive for rotavirus.|||participants|||Number
1407887|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers.|1 year|Children hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers|||percentage of participants||95% Confidence Interval|Number
1407888|NCT01195844|Primary|The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus|Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. For each geographic location, the number of hospitalizations for diarrhea that was caused by rotavirus was reported.|1 year|The population analyzed was children up to 5 years of age hospitalized for diarrhea. A total of 190 of the 230 participants had fecal samples analyzed; 27 of these had stool samples positive for rotavirus.|||Participants|||Number
1407889|NCT01195844|Primary|The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The percentage of total hospitalizations for children up to 5 years of age in the 4 Brazilian hospital research centers that were for diarrhea. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|"The population to be analyzed was all hospitalizations for any reason for children up to 5 years of age in the 4 hospital research centers~The number of total hospitalizations for children up to 5 years of age was not known; thus this outcome measure was not evaluated"||||||
1407890|NCT01195844|Primary|The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age|The total number of hospitalizations for diarrhea in children up to 5 years of age in the 4 Brazilian hospital research centers was reported. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.|1 year|The population analyzed was all enrolled participants whether or not a fecal sample was obtained|||participants|||Number
1407891|NCT01195831|Secondary|Evaluation of the Quality of Life||Baseline to weeks 2 and 4|||||||
1407892|NCT01195831|Secondary|Patients With Success (Patient's Itching Score=None) at Week 4||4 weeks|||||||
1407893|NCT01195831|Secondary|For Each Clinical Sign (Redness, Thickness, Scaliness), the Percentage of Patients With Success (Clinical Score=0) at Week 4||4 weeks|||||||
1407894|NCT01195831|Secondary|Patients With Success (Total Sign Score ≤1) at Week 4|"Investigators assessed scalp psoriasis lesions in terms of three clinical signs: redness, thickness and scaliness. For each clinical sign a single score, reflecting the average severity of all lesions on the scalp, was derived according to a 5-point scale ranging from 0 to 4 (0= best;4= worst). The sum of the three individual scores (redness, thickness and scaliness) constituted a Total Sign Score of the scalp ranging from 0 to 12 (0= best;12= worst). Patients with a Total sign score of 0 or 1 at week 4 achieved Success."|4 weeks||||percentage of participants|||Number
1407895|NCT01195831|Secondary|"Patients With Controlled Disease in Term of Clear or Very Mild According to Patient's Global Assessment of Disease Severity at Week 4."|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 4 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|4 weeks||||percentage of participants|||Number
1408537|NCT01192282|Primary|HPV DNA and HIV Status|HPV DNA Positivity and HIV Status|18 Months|Only 126 out of 156 samples collected from each patients were analysed as 30 of the samples were contaminated, of which 22 were from HIV Positive patients and 8 were from HIV Negative patients.|||participants|||Number
1407896|NCT01195831|Secondary|Patients With “Controlled Disease” in Terms of “Clear” or “Very Mild” According to Patient’s Global Assessment of Disease Severity at Week 2.|Patients made a global assessment of the disease severity by use of a 5-point scale (Clear, Very Mild, Mild, Moderate, Severe). Patients classifying their disease as Clear or Very Mild at week 2 were rated as having Controlled disease. This assessment was made prior to the investigator's assessments.|2 weeks||||percentage of participants|||Number
1407897|NCT01195831|Secondary|Patients With “Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 2|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease at week 2 were rated as having Controlled disease.|2 weeks||||percentage of participants|||Number
1407898|NCT01195831|Primary|Patients With ”Controlled Disease” in Terms of “Clear” or “Minimal” According to Investigator’s Global Assessment of Disease Severity at Week 4.|Investigators made a global assessment of the disease severity by use of a 6-point scale (Clear, Minimal, Mild, Moderate, Severe and Very Severe). Patients with disease severity classified as Clear or Minimal disease after the treatment period (week 4) were rated as having Controlled disease.|4 weeks||||percentage of parcipitants|||Number
1407899|NCT01195779|Secondary|Number of Subjects Reporting Serious Adverse Events|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 179||||Subjects|||Number
1407900|NCT01195779|Secondary|Number of Subjects Reporting Potential Immune-mediated Diseases|Potential Immune-Mediated Diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407901|NCT01195779|Secondary|Number of Subjects Reporting Adverse Events With Medically Attended Visits|A mediaclly attended visit is defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|From Day 0 to 179|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407902|NCT01195779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|within 28 days (Day 0 to Day 27) after any vaccination||||Subjects|||Number
1407903|NCT01195779|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Solicited general symptoms included drowsiness, fever, irritability and loss of appetite.|during a 7 day follow-up period (Day 0 to 6) after any vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407904|NCT01195779|Secondary|Serum Neutralising Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407905|NCT01195779|Secondary|Serum HI Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|on Days 0, 28/56 and 180|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407906|NCT01195779|Primary|Number of Subjects Reporting Fever of at Least Grade 2 or Higher|Grade 2 fever was defined as axillary temperature above 38 degrees Celcius.|Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407907|NCT01195779|Primary|Geometric Mean Number of All-CD4 Cytokine Positive Cells|Geometric mean of the number of CD4 cytokine positive T cells per million T cells.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407908|NCT01195779|Primary|Serum Neutralizing Antibody Titers||at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407909|NCT01195779|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers|Titers were planned to be expressed as Geometric Mean Titers (GMTs). Analysis was planned to be done for antibodies against all 4 vaccine strains.|at Day 28/ Day 56|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1407910|NCT01195701|Secondary|FSFI Pain|The pain domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of discomfort or pain during and following vaginal penetration (almost never to almost always), and the level of discomfort or pain (very low to very high). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the pain score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
1407911|NCT01195701|Secondary|FSFI Satisfaction|The satisfaction domain of the Female Sexual Function Index (FSFI) consists of three questions and measures satisfaction (very dissatisfied to very satisfied) with emotional closeness with partner, sexual relationship with partner, and overall sexual relationship with partner. Item scores range from 0 (or 1) to 5, with higher scores indicating better sexual function, and the satisfaction score is weighted by a factor of 0.4, such that the domain score can range from 0.8 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
1407912|NCT01195701|Secondary|FSFI Orgasm|The orgasm domain of the Female Sexual Function Index (FSFI) consists of three questions and measures the frequency of orgasm (almost never to almost always), difficulty in achieving orgasm (extremely difficult to not difficult), and satisfaction with the ability to reach orgasm (very dissatisfied to very satisfied). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the orgasm score is weighted by a factor of 0.4, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
1419593|NCT01102374|Secondary|Number of Influenza-like Illnesses||12 months|collected together with lower respiratory infections (not as a separate category)||||||
1407913|NCT01195701|Secondary|FSFI Lubrication|The lubrication domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency of lubrication (almost never to almost always), the difficulty in becoming lubricated (extremely difficult to not difficult), frequency of maintaining lubrication (almost never to almost always), and difficulty in maintaining lubrication (extremely difficult to not difficult). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the lubrication score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
1407914|NCT01195701|Secondary|FSFI Arousal|The arousal domain of the Female Sexual Function Index (FSFI) consists of four questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual arousal; and confidence in becoming aroused (very low to very high confidence) and frequency of satisfaction with arousal (almost never to almost always). Item scores range from 0 to 5, with higher scores indicating better sexual function, and the arousal score is weighted by a factor of 0.3, such that the domain score can range from 0 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
1407915|NCT01195701|Secondary|FSFI Desire|The desire domain of the Female Sexual Function Index (FSFI) consists of two questions and measures the frequency (almost never to almost always) and level (very low to very high) of sexual desire. Item scores range from 1 to 5, with higher scores indicating better sexual function, and the domain score is weighted by a factor of 0.6, such that the domain score can range from 1.2 to 6.0.|baseline visit||||units on a scale||Standard Deviation|Mean
1407916|NCT01195701|Secondary|Female Sexual Function Index (FSFI) Total Score|The FSFI is a validated index of sexual function, consisting of a total score and six subscales or domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI total is the sum of the six domain scores, each of which is weighted as noted. The FSFI total score can range from 2 to 36, with higher scores indicating better sexual function. A total score of 26.55 has been identified as the ideal cut point for differentiating between normal sexual function and sexual dysfunction.|baseline visit||||units on a scale||Standard Deviation|Mean
1407917|NCT01195701|Secondary|Free Androgen Index|Free androgen index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG)|Between day 1-14 (follicular phase) of menstrual cycle||||ratio||95% Confidence Interval|Number
1407918|NCT01195701|Secondary|Total Testosterone|Free & total testosterone, and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle||||ng/dL||Inter-Quartile Range|Median
1407919|NCT01195701|Secondary|Free Testosterone|Free testosterone and the calculated free androgen index will be compared; additionally, these levels will be correlated with the questionnaire data and clitoral measurements|Between day 1-14 (follicular phase) of menstrual cycle||||pg/mL||Inter-Quartile Range|Median
1407920|NCT01195701|Primary|Clitoral Measurements Using Pelvic MRI|All cases and controls will undergo a pelvic MRI without contrast to assess the clitoral complex.|Between day 1-14 (follicular phase) of menstrual cycle||||millimeters (mm)||Standard Deviation|Mean
1407921|NCT01195675|Other Pre-specified|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Drug administration until beginning of next sequence/end of trial, up to 48 days|Treated set (TS): All subjects who were dispensed trial medication and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
1407922|NCT01195675|Other Pre-specified|Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings.|"The placebo corrected change from mean baseline is defined per time point as the difference of the change from baseline for empa or moxifloxacin minus the average change from baseline obtained for the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.~Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms||Standard Deviation|Mean
1407923|NCT01195675|Other Pre-specified|Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing.|"The time-matched change from placebo is defined per time point as the difference of the ECG measurement following administration of empa or moxifloxacin minus the average of the measurements obtained following the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.~Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms||Standard Deviation|Mean
1407924|NCT01195675|Primary|Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg.~Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Deviation|Mean
1409155|NCT01188460|Primary|Sleep Diary- Sleep Quality|"Measures:~Sleep Quality (units on a scale from 0-10), higher scores indicate better outcomes"|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
1407925|NCT01195675|Secondary|Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.~For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen.~Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
1407926|NCT01195675|Secondary|Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings|"Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time.~For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen.~Note, the presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
1407927|NCT01195675|Secondary|Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings~Note, the means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
1407928|NCT01195675|Secondary|Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg.~Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Deviation|Mean
1407929|NCT01195675|Secondary|Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing|"Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg.~Note, presented means are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
1407930|NCT01195675|Primary|Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing|"Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg.~Note, the treatment means presented are actually adjusted means."|60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose|Full analysis set (FAS): all treated subjects who had at least one baseline assessment and at least one post-baseline assessment for at least one ECG endpoint.|||ms|Participants|Standard Error|Mean
1407931|NCT01195662|Secondary|Proportion of Participants With Orthostatic Hypotension at Baseline and Week 12, Including Data After Rescue|Orthostatic hypotension was defined as a decrease from supine to standing of > 20 mmHg in systolic BP or >10 mmHg in diastolic BP. Proportion was calculated from number of participants with orthostatic hypotension (n) divided by the number of treated participants (N). n/N presented as a percent (%). Baseline was Day 1 of the double blind Period. Measurements for orthostatic hypotension were taken on Day 1 and at Week 12 visit and does not reflect AEs reported by the investigator.|Baseline (Day 1), Week 12|N= All randomized participants who received double-blind medication and had non-missing Week (t) values. Week 12 includes participants with orthostatic hypotension during Week 12 visit window. Data after rescue included.|||Percent of Participants|||Number
1407932|NCT01195662|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 12 (LOCF), Including Data After Rescue|12-Lead electrocardiograms (ECGs) were performed at Enrollment, Day 1 of Double Blind Period and Week 12/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator as normal or abnormal. Baseline (BL) was Day 1 prior to dosing or last observation prior to dosing.|Baseline, Week 12|N= All randomized participants who received double-blind medication. Data after rescue included.|||participants|||Number
1407933|NCT01195662|Secondary|Number of Participants With Elevated Liver Laboratory Tests in Participants Treated With Double Blind 10 mg Dapagliflozin or Placebo , Including Data After Rescue|Laboratories were obtained at Day 1, Weeks 4, 8 and 12 in the Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Includes laboratory values measured after the first date of double-blind treatment and up to and including the last day of double blind treatment plus 30 days. Upper limit of normal (ULN);, alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality (High): AST and ALT (>3*ULN); ALP (>1.5*ULN); bilirubin (>1.5*ULN). Participants with abnormally elevated liver laboratory tests were followed 30 days after the last dose of study drug.|Baseline (Day 1) to last dose double blind medication (Week 12) Plus 30 days|N=All randomized participants who received at least 1 dose of study medication. n=number of participants treated with double blind study medication with at least one non-missing post-baseline value. Data after rescue included.|||participants|||Number
1407979|NCT01195363|Primary|Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.|The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.|Baseline visit to week 24|Per Protocol|||participants|||Number
1407934|NCT01195662|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities in 12 Week Double Blind Treatment Period, Including Data After Rescue|Samples obtained: Day 1, Weeks 4, 8,12 in Double Blind Period. Baseline: last assessment prior to start of first dose of double-blind treatment. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), Marked abnormality Low (High): hemoglobin <6 (>18 females or >20 males) g/dL; creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose < 54 or (> 350) mg/dL; albumin <= 2 or (> 6) g/dL; creatine kinase >5*ULN; albumin/creatinine ratio (>1800 mg/G); calcium <7.5 (>1 and >0.5 from PreRX) mg/dL; bicarbonate <=13 meq/dL; potassium <=2.5 (>6) meq/L; magnesium <1 (>4) mEq/L; sodium < 130 mEq/L (>150 mEq/L; phosphorus (>=5.6 mg/dL age 17-65, >=5.1 is >=66 years); Albumin/creatinine ratio (>1800 mg/g). Note: Hepatic tests are presented separately in next outcome measure.|Baseline (Day 1) to last dose double blind medication (Week 12) plus 4 days|N=All randomized participants who received at least one dose of double-blind medication. n=all treated participants who had non-missing Baseline and on-study measurement. Data after rescue included.|||participants|||Number
1407935|NCT01195662|Secondary|Number of Participants With Deaths,Serious Adverse Events (SAEs), Adverse Events (AEs), Hypoglycemia Events, Discontinuation Due to AEs, SAEs and Hypoglycemia, During the 12 Week Double Blind Period, Including Data After Rescue|Medical Dictionary for Regulatory Activities (MedDRA), version 15.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last double blind dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Only hypoglycemia reported as an SAE is included in AE/SAE categories . All reported hypoglycemia events within 4 days of last day of treatment are included as hypoglycemic events.|Baseline to last dose of 12 weeks of double blind medication plus 30 days if SAE or plus 4 days if AE/hypoglycemic event|Randomized participants who received double-blind study medication in the double-blind period.|||participants|||Number
1407936|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid at Week 12 in Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in serum uric acid from baseline at Week 12 was calculated. Serum uric acid was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Serum uric acid measurements were obtained at qualification and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period but only the change from baseline at Week 12 was considered a secondary endpoint and is presented.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue was included.|||mg/dL||Standard Error|Mean
1407937|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hr Ambulatory Diastolic Blood Pressure at Week 12 (LOCF)|Ambulatory 24 hour (hr) BP monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF). Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained. The ABPM units were calibrated, and used per the manufacturer’s and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement (Week 12 LOCF). Data after rescue excluded from analyses.|||mmHg||Standard Error|Mean
1407938|NCT01195662|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure (DBP) for 12 Week Double-Blind Treatment Period - Randomized Participants|Diastolic BP was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Diastolic BP values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the pressure was higher in one arm than the other, then this arm was used; if no difference, the participant’s dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses|||mmHg||Standard Error|Mean
1407939|NCT01195662|Secondary|Adjusted Mean Change From Baseline in 24-hour Ambulatory Systolic Blood Pressure at Week 12 Last Observation Carried Forward (LOCF)|Ambulatory 24 hour (hr) blood pressure monitoring (ABPM) was performed at baseline, which was during the lead-in period (between Day -7 and Day -1 prior to randomization) and 1 week prior to the Week 12 visit/end of treatment visit. If no Week 12 measurement was available, the last available earlier post-baseline measurement was used (LOCF) for analysis. Initiation of the 24-hr ABPM began between 6am and 11am to ensure trough BP measurements were obtained.The ABPM units were calibrated, and used per the manufacturer’s and central ABPM vendor instructions. BP was measured in mmHg. Participants had to have a mean 24-hour ABPM ≥ 130/80 mmHg prior to randomization. All medication was withheld on the morning of the study visit and brought to the visit site by the participant. Once the ABPM cuff was in place, all morning medication was taken while at the site.|Baseline, Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and Week 12 (LOCF) values. Data after rescue excluded from analyses.|||mmHg||Standard Error|Mean
1408538|NCT01192204|Secondary|Treatment Changes in Loss of Heterozygosity Events|Laboratory experiments will be conducted to assess the effects of gel treatment on pre and post loss of heterozygosity (LOH) events at loci associated with tumor suppressor genes.|Before and after the 3 month treatment duration||||LOH events||Standard Error|Mean
1407940|NCT01195662|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) for 12 Week Double-Blind Treatment Period - Randomized Participants|Adjusted mean change in glycosylated hemoglobin ( HbA1c) from baseline at Week 12 was calculated. HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment and lead-in (Day -28) periods, and at Day 1, Weeks 4, 8, and 12, in the double-blind period.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue included.|||Percent of Hemoglobin||Standard Error|Mean
1407941|NCT01195662|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure for 12 Week Double-Blind Treatment Period - Randomized Participants|Systolic blood pressure (SBP) was measured in millimeters of mercury (mmHg) on Day -1, Day 1, Weeks 2, 4, 8, and 12 of the Double Blind Period. Blood pressure (BP) values were obtained after the participant was seated for quietly for 10 minutes; a mean of 3 replicate measurements was taken at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were obtained (total = 5) and incorporated into the calculated mean. BP was measured in both arms. If the BP was higher in one arm than the other, then this arm was used; if no difference, the participant’s dominant arm was used for all future BP measurements. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. Participants refrained from ingestion of caffeine, alcohol, or nicotine at least 10 hours prior to their visit and having their BP measured.|Baseline to Week 12|All randomized participants who received double-blind medication and had non-missing Baseline and on-study measurement. Data after rescue excluded from analyses|||mmHg||Standard Error|Mean
1407942|NCT01195636|Secondary|Change in Daily Sleep Interference Scale (DSIS) From Baseline to Week 3 of XPF-002 Treatment Compared to Week 3 of Placebo Treatment (With LOCF)|"Subjects recorded their sleep interference scores each morning for the previous night's sleep (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no interference with sleep and 10 = pain completely interfered with sleep). A daily sleep interference score was calculated.~This measurement is the 'Change in DSIS score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing scores were imputed using last observation carried forward (LOCF).~The reduction in DSIS on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in sleep interference due to pain. (A positive number would indicate sleep interference due to pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."|||units on a scale||95% Confidence Interval|Least Squares Mean
1407943|NCT01195636|Secondary|Change in Overall Neuropathic Pain Symptom Inventory (NPSI) From Baseline to Week 3 (With LOCF)|"Subjects completed the NPSI questionaire at various timepoints during the study. An overall NPSI score (the sum of 10 quantitative responses, each scored 0-10, max score = 100) was calculated each time the NPSI questionaire was completed.~This measurement is the 'Change in Neuropathic Pain Symptom Inventory (NPSI) score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject. If the NPSI score for Week 3 was missing, the last value from within the same treatment period was used (ie last observation carried forward (LOCF)).~The reduction in NPSI on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in neuropathic pain symptoms. (A positive number would indicate neuropathic pain symptoms were increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."|||units on a scale||Standard Deviation|Mean
1407944|NCT01195636|Secondary|Proportion of Subjects Using Rescue Analgesic Medications During XPF-002 Treatment Compared to Placebo Treatment||3 Weeks||||participants|||Number
1407945|NCT01195636|Secondary|Proportion of Subjects Achieving 30% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||participants|||Number
1407946|NCT01195636|Secondary|Proportion of Subjects Achieving 50% Improvement in Mean Daily Pain Score From Baseline to Week 3 on XPF-002 Treatment Compared to Placebo Treatment||3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||participants|||Number
1407947|NCT01195636|Secondary|Proportion of Subjects Achieving at Least a 1 Point Improvement in Mean Daily Pain Score (Measured Using the 11-point Likert NRS) From Baseline to Week 3 on XPF-002 Compared to Placebo|Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||participants|||Number
1407980|NCT01195272|Secondary|Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments|Benefit:Risk was defined at the participant level. It was considered acceptable if the DAS28 improvement represented at least a moderate European League Against Rheumatism (EULAR) response. The risks were based on the known adverse event (AE) profile of tocilizumab rather than on the actual AEs experienced by each participant|Weeks 12, 24, and 36|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of participants|||Number
1419594|NCT01102374|Secondary|Number of Lower Respiratory Infections||12 months||||events|||Number
1407948|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 3|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 Weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||units on a scale||95% Confidence Interval|Least Squares Mean
1407949|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 2|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 2nd week of XPF-002 treatment and the 2nd week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|2 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||units on a scale||95% Confidence Interval|Least Squares Mean
1407950|NCT01195636|Secondary|Change in Mean Daily Pain Score From Baseline to Week 1|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 1st week of XPF-002 treatment and the 1st week of placebo treatment for each subject'. Missing data were not imputed.~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|1 week|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods.~Missing data were not imputed. Only subjects who recorded sufficient pain scores in each treatment period were included in this analysis."|||units on a scale||95% Confidence Interval|Least Squares Mean
1407951|NCT01195636|Primary|Change in Mean Daily Pain Score From Baseline to Week 3 (With LOCF)|"Subjects recorded their pain scores 4 times each day (using an 11-point Likert numerical rating scale (NRS); 0-10, where 0 = no pain and 10 = worst pain imaginable). An average (mean) daily pain score was calculated.~This measurement is the 'Change in mean daily pain score from baseline between the 3rd week of XPF-002 treatment and the 3rd week of placebo treatment for each subject'. Any missing mean daily pain scores were imputed using last observation carried forward (LOCF).~The reduction in pain on each treatment compared to baseline is reported as a negative number. A larger negative number, indicates a greater reduction in pain. (A positive number would indicate pain was increased compared to baseline.)"|3 weeks|"The Efficacy Evaluable Population was used for this analysis. This population includes randomised subjects who recorded both baseline and post-baseline data in both treatment periods. The maximum number of subjects who could contribute to this population is 57.~Last Observation Carried Forward (LOCF) was used to impute any missing data."|||units on a scale||95% Confidence Interval|Least Squares Mean
1407952|NCT01195623|Secondary|Recurrence Rate|number of recurrences in treatment arms but also nature of recurrences|7 years|The number of legs with recurrence of varicose veins in the saphenofemoral junction (SFJ)or saphenopopliteal junction (SPJ)|||legs|Participants||Number
1407953|NCT01195623|Primary|Rate of Re-do Surgery|number of reoperations (legs) in the two treatment arms|7 years mean|The number of legs has been analyzed, randomized 166 legs in the duplex group and 177 in the no-duplex group|||legs|||Number
1407954|NCT01195597|Secondary|Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)|Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)|||number of participants|||Number
1407955|NCT01195597|Primary|Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)|Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).|number of cigarettes/day as assessed at week 24|Intention to treat (ITT)|||number of participants|||Number
1407956|NCT01195584|Secondary|Days of Hospitalization|Total time of hospitalization.|at hospital discharge|analysis per protocol|||Days||Standard Deviation|Mean
1407957|NCT01195584|Secondary|Drainage|Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured.|at hospital discharge|analysis per protocol|||ml||Standard Deviation|Mean
1407958|NCT01195584|Secondary|Number of Spine Segments|Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs.|peri operative|analysis per protocol|||spine segments||Standard Deviation|Mean
1407959|NCT01195584|Secondary|Blood Loss|Loss of blood during surgical procedure in milliliters.|after surgery|analysis per protocol|||ml||Standard Deviation|Mean
1407960|NCT01195584|Secondary|Operation Duration|Duration of the operation in minutes.|after surgery|analysis per protocol|||Minutes||Standard Deviation|Mean
1407961|NCT01195584|Primary|Postoperative Complications in the BMI Groups During Post Operative Hospitalization.|Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.|at hospital discharge|Analysis per protocol|||Events during hospitalization|||Number
1419595|NCT01102374|Secondary|Number of Upper Respiratory Infections||12 months||||events|||Number
1407962|NCT01195545|Secondary|Pre and Post-operative Symptoms|"Dysphagia frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Dysphagia. The Dysphagia frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Dysphagia.~The Dysphagia VAS score was measured pre-operative and post-operative. The comparison of Dysphagia VAS score pre-operative and post-operative indicated that some participants experienced Improvement and others worsen."|Pre-surgery and 6 month follow up|Pre-surgery and a median of 6 month follow up (3-6months)|||Participants|||Count of Participants
1407963|NCT01195545|Secondary|Pre and Post-operative Symptoms|"Regurgitation frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Regurgitation. The Regurgitation frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Regurgitation.~The Regurgitation VAS score was measured pre-operative and post-operative. The comparison of Regurgitation VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement."|Pre-surgery and 6 month follow up|Pre-surgery an at median follow up of 6 month (3-6 month)|||Participants|||Count of Participants
1407964|NCT01195545|Secondary|Pre and Post-operative Symptoms|"Heartburn frequency Pre and Post-operative was measured using the Paraesophagel Hernia Patient Questionnaire-Visual analog score (VAS). The VAS measures subjective characteristics that specify the respondents level of agreement to a statement. In this questionnaire, the patient indicated how frequent they had Heartburn. The Heartburn frequency measurement scale: 0=Never, 1=once/month,2=once/week,3=once/day,4=several/day. The lower the VAS score the better the outcome meaning less episodes of Heartburn.~The Heartburn VAS score was measured pre-operative and post-operative. The comparison of Heartburn VAS score pre-operative and post-operative indicated that participants experienced Improvement and No Improvement."|Pre-surgery and 6 month follow up|Pre-surgery and at a median follow up 6 months month (range 3 – 10 months)|||Participants|||Count of Participants
1407965|NCT01195545|Primary|Recurrence Rate of Hiatal Hernia Rate Based on Upper Gastrointestinal (UGI) Series|Number of subjects experiencing recurrence greater than 2cm as well as 5cm post surgery.|6 months post procedure|6 months post-op follow up|||Participants|||Count of Participants
1407966|NCT01195467|Secondary|Change From Baseline of CNS Toxicity as Measured by Hospital Anxiety and Depression (HADS) Score (Baseline vs Week 12)|To assess the change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12)|baseline to week 12|||||||
1407967|NCT01195467|Secondary|Change From Baseline in Adherence From Baseline After 12 Weeks of Raltegravir as Measured by the Adherence Questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|To assess the change from baseline in adherence from baseline after 12 weeks of raltegravir as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)|baseline to week 12|||||||
1407968|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Non-CNS Adverse Events After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 non-CNS adverse events after 12 weeks of raltegravir compared with baseline|baseline to week 12|||||||
1407969|NCT01195467|Secondary|Proportion of Patients With Grade 2-4 Laboratory Parameters (Excluding Lipids) After 12 Weeks of Raltegravir Compared With Baseline|To assess the proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 12 weeks of raltegravir compared with baseline|baseline to week 12|||||||
1407970|NCT01195467|Secondary|Change in Fasting Lipids (Total Cholesterol and Subfractions and Triglycerides) After 4 and 12 Weeks of Raltegravir|To assess the change in fasting lipids (total cholesterol and subfractions and triglycerides) after 4 and 12 weeks of raltegravir|week 4 to week 12|||||||
1407971|NCT01195467|Secondary|Proportion of Patients With Viral Load < 50 Copies/mL and <400 Copies/ml at Weeks 4 and 12 After Switching to Raltegravir|To assess the proportion of patients with viral load < 50 copies/mL and <400 copies/ml at weeks 4 and 12 after switching to raltegravir|week 4 to week 12|||||||
1407972|NCT01195467|Secondary|Change From Baseline to Week 12 in CD4+ Count After 12 Weeks of Raltegravir|Change from baseline to week 12 in CD4+ count after 12 weeks of raltegravir having switched from efavirenz-containing therapy|baseline to week 12|||||||
1407973|NCT01195467|Secondary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment|"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)"|baseline to week 12||||percentage of improvement in sleep score|||Number
1407974|NCT01195467|Primary|The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment|To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)|4 weeks||||percentage improvement in CNS score|||Number
1407975|NCT01195415|Secondary|Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0||Up to 4 weeks||||percentage of patients|||Number
1407976|NCT01195415|Secondary|Median Progression Free Survival|Median progression free survival was calculated for all treated patients. Assessed using the Kaplan-Meier method. The 95% confidence interval for this estimate will be computed using the Greenwood’s formula.|Up to 24 months||||months||95% Confidence Interval|Median
1407977|NCT01195415|Secondary|The Number of Participants With an Objective Best Response (CR + PR)|The number of participants with either a complete response (CR) or a partial response (PR) will be calculated. A CR is defined as the disappearance of all target lesions. A PR is defined as at least a 30% decrease in the sum of the diameters of target lesions.|Up to 4 weeks|All treated patients were evaluable.|||participants|||Number
1412486|NCT01161862|Primary|Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)||48 hours|Overall number of participants was 24, 12 in each arm|||mg/dl||Standard Deviation|Mean
1407981|NCT01195272|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index includes swollen and tender joint counts, acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]), and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS, which includes a 44 swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||score on a scale||Standard Deviation|Mean
1407982|NCT01195272|Primary|Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation|Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of positive neutrophils||Standard Deviation|Mean
1407983|NCT01195272|Primary|Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake|S. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis.|Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of positive neutrophils||Standard Deviation|Mean
1407984|NCT01195272|Primary|Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||chemiluminescence units * hours||Standard Deviation|Mean
1407985|NCT01195272|Primary|Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation|Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.|Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||chemiluminescence units*hours||Standard Deviation|Mean
1407986|NCT01195272|Primary|Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
1407987|NCT01195272|Primary|Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
1407988|NCT01195272|Primary|Mean Fluorescence Intensity of CD63 on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
1407989|NCT01195272|Primary|Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface|Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls.|Visits 2, 3 and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
1407990|NCT01195272|Primary|Mean Fluorescence Intensity of CD18 on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed at each visit|||fluorescence intensity unit||Standard Deviation|Mean
1407991|NCT01195272|Primary|Mean Fluorescence Intensity of CD11b on Neutrophil Surface|Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.|Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||fluorescence intensity unit||Standard Deviation|Mean
1408016|NCT01195090|Secondary|Change in Fasting Total-cholesterol|Total-cholesterol change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
1408017|NCT01195090|Secondary|Percentages of Patients With Total Adverse Events (AE)|percentages of total adverse events|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
1413465|NCT01153633|Primary|Percent Change of Wound Size From Baseline to Last Visit||12 Weeks|Per protocol set|||percentage change in wound size (cm2)||Standard Error|Least Squares Mean
1407992|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|ITT Population; n=number of participants analyzed for the specified parameter at a given visit.|||percentage of cells staining positive||Standard Deviation|Mean
1407993|NCT01195272|Primary|Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis|Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis.|Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)|Intent-to-treat (ITT) Population: all participants in the Safety Population who provided follow-up data for neutrophils or at least 1 efficacy variable. n (number) equals (=) number of participants analyzed for the specified parameter at a given visit.|||percentage of cells staining positive||Standard Deviation|Mean
1407994|NCT01195116|Primary|Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU|It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.|Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average||||units on a scale||Standard Deviation|Mean
1407995|NCT01195103|Primary|Percentage of Participants Achieving Sedation Within 4 Minutes|"Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals lethargic response to name spoken in normal tone."|approximately 4 minutes after administration of first bolus of study drug||||percentage of participants|||Number
1407996|NCT01195090|Secondary|Baseline High-density Lipoprotein Cholesterol (HDL-C)|Baseline HDL-C|Baseline|Baseline HDL-C|||mg/dl||Standard Deviation|Mean
1407997|NCT01195090|Secondary|Baseline Low-density Lipoprotein Cholesterol (LDL-C)|Baseline LDL-C|Baseline|Baseline LDL-C|||mg/dl||Standard Deviation|Mean
1407998|NCT01195090|Secondary|Baseline Triglyceride (TG)|Baseline TG|Baseline|Baseline TG|||mg/dl||Standard Deviation|Mean
1407999|NCT01195090|Secondary|Baseline Total Cholesterol|Baseline Total cholesterol|Baseline|Baseline Total cholesterol|||mg/dl||Standard Deviation|Mean
1408000|NCT01195090|Secondary|Baseline Body Weight|Baseline body weight|Baseline|Baseline body weight|||kg||Standard Deviation|Mean
1408001|NCT01195090|Secondary|Baseline Alanine-aminotransferase (ALT)|Baseline alanine-aminotransferase|Baseline|Baseline alanine-aminotransferase|||IU/L||Standard Deviation|Mean
1408002|NCT01195090|Secondary|Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Baseline HOMA-IR|Baseline HOMA-IR|Baseline HOMA-IR|||HOMA-IR score||Standard Deviation|Mean
1408003|NCT01195090|Secondary|Baseline High Sensitive C-reactive Protein|Baseline high sensitive C-reactive Protein|baseline|Baseline high sensitive C-reactive Protein|||mg/dl||Standard Deviation|Mean
1408004|NCT01195090|Secondary|Baseline Fasting Plasma Glucose|Baseline fasting plasma glucose|baseline|Baseline fasting plasma glucose|||mg/dl||Standard Deviation|Mean
1408005|NCT01195090|Secondary|Percentages of Patients With Severe Hypoglycemia|Proportion of severe hypoglycemia after treatment|24 weeks|Proportion of severe ypoglycemia after treatment|||percentage|||Number
1408006|NCT01195090|Primary|The Percentages of Patient Achieving an A1C <7%|The percentages of patient achieving an A1C <7% at endpoint|24 weeks|The percentages of patient achieving an A1C <7% at endpoint|||percentage|||Number
1408007|NCT01195090|Primary|Baseline A1C|baseline A1C|Baseline|baseline Laboratory measurements|||percentage of Hb||Standard Deviation|Mean
1408008|NCT01195090|Secondary|Percentages of Patients With Nasopharyngitis|Proportion of Nasopharyngitis after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
1408009|NCT01195090|Secondary|Percentages of Patients With Gastrointestinal Adverse Events|Proportion of Gastrointestinal adverse events after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentge|||Number
1408010|NCT01195090|Secondary|Percentages of Patients With Edema|proportion of edema after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
1408011|NCT01195090|Secondary|Percentages of Patients With Mild to Moderate Hypoglycemia|Incidence of mild to moderate hypoglycemia after treatment|24 weeks|All patients who had taken at least one dose of study medication were included in the safety analysis|||percentage|||Number
1408012|NCT01195090|Secondary|Change in Fasting Plasma Alanine-aminotransferase (ALT)|ALT change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||IU/L||Standard Error|Least Squares Mean
1408013|NCT01195090|Secondary|Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)|HDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
1408014|NCT01195090|Secondary|Change in Fasting Triglycerides(TG)|TG change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy.|||mg/dl||Standard Error|Least Squares Mean
1408015|NCT01195090|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C change from baseline to 24 weeks|24 weeks|An intent-to-treat analysis with last observation carried forward was used to assess efficacy|||mg/dl||Standard Error|Least Squares Mean
1419596|NCT01102374|Secondary|Fractures||12 months||||events|||Number
1408023|NCT01195025|Primary|Elimination Half Life for Different Fluids Alone or When Combined|Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.|420 minutes|All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers. Each experiment generated one elimination half-life (In experiment C one for acetated Ringer's and one for starch (HES 6%)).|||Minutes|Participants|Inter-Quartile Range|Median
1408024|NCT01195025|Secondary|Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.|The investigators will measure a few markers of coagulation (fibrinogen, thrombocytes, D-Dimer, PK-INR, aPTT, and coagulation factor VII) as well as Cystatin C, serum albumine and hemoglobin and how the concentration of these vary with the different dilutions of blood during and after infusion of a colloid and/or a crystalloid solution.|420 minutes||2015-05-31|05/2015||||
1408025|NCT01195025|Secondary|Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)|"Difference between true hemoglobin B-Hb and measured hemoglobin with pulseoximeter (SpHb)at the end of an infusion in relation to the initial measured values SpHb and B-Hb at the start of the infusion.~Relative difference (%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"|30 min|Only the pure experiments were included in this analysis. The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant.|||percentage of relative difference|Participants|Inter-Quartile Range|Median
1408026|NCT01195025|Secondary|Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids|"Pulse-oximeter based measurements compared with invasive hemoglobin measurements. All paired in the study.~Accuracy depending on which infusion is selected (Ringer's, Hydroxyethyl starch or a combination of both)."|420 min|The study was analysed per protocol and missing values were not replaced. All pairs of all collected data in one series of experiments. The number of analysed data points for each subject was in experiment A: 26, in experiment B: 32 and in experiment C: 42.|||percentage of relative difference|Participants|Inter-Quartile Range|Median
1408027|NCT01195025|Primary|Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.|"volume kinetics: mathematical calculation from hemoglobin variations during and after an infusion.~Degree of plasma dilution depending on which solution(s) and how much solution is/are given."|420 minutes|"All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers.~Each experiment generated one distribution volume. (In experiment C one for acetated Ringer's and one for Starch (HES 6%))."|||Litre||Inter-Quartile Range|Median
1408028|NCT01194999|Primary|Change in OAB Symptoms Post Pubovaginal Sling Operation|Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.|Baseline to final follow-up.|All patients enrolled in the study were analyzed, except for those currently being treated with antimuscarinic therapy.|||participants|||Number
1408029|NCT01194973|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1408030|NCT01194973|Secondary|Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline sustained for at least two consecutive measurements obtained at least four weeks apart|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized for each parameter.|||Percentage of Participants||95% Confidence Interval|Number
1408031|NCT01194973|Secondary|Percentage of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408032|NCT01194973|Secondary|Percentage of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408033|NCT01194973|Secondary|Percentage of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
1408047|NCT01194856|Secondary|Compare Changes in Levels of Hs-CRP Between the Two Arms|To examine the effect of switching from EFV to ATV/r on highly sensitive C-reactive protein (hs-CRP) in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in hs (highly sensitive) - CRP levels between the EFV arm and the ATV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1419597|NCT01102374|Secondary|Falls||12 months||||Events|||Number
1408034|NCT01194973|Secondary|Percentage of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response through end of study was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 52 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
1408035|NCT01194973|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures Analysis of variance (ANOVA) model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1408036|NCT01194973|Secondary|Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m^2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408037|NCT01194973|Secondary|Percentage of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408038|NCT01194973|Secondary|Percentage of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408039|NCT01194973|Primary|Percentage of Patients With Modified Complete TMA Response|Proportion of Patients with Modified Complete TMA response through 26 weeks of treatment was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Modified Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
1408040|NCT01194973|Primary|Percentage of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as < 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
1408041|NCT01194908|Secondary|To Determine the Safety of Tamoxifen in Combination With Decitabine and LBH589||Patients will undergo an evaluation for extent of disease 8 weeks from starting study drugs and every 8 weeks (2 cycles) while on study.|No data were analyzed due to trial termination.||||||
1408042|NCT01194908|Primary|To Determine the Maximum Tolerated Dose of Decitabine and LBH589 Given in Combination in Patients With Metastatic or Locally Advanced Metastatic Breast Cancers||Estrogen receptor status checked 5 days after treatment. Staging is done every 8 weeks.|No data were analyzed due to trial termination.||||||
1408043|NCT01194869|Secondary|Clinical Response Rate (Complete Pathologic Response Rate After Surgery)|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen during follow-up. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|Up to 2 years after definitive surgery||||participants|||Number
1408044|NCT01194869|Secondary|Clinical Response Rate During Follow-up (Disease Recurrence)|Response will be assessed according to World Health Organization criteria with progressive disease (PD) defined as a 25% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.|Up to 2 years after definitive surgery||||participants|||Number
1408045|NCT01194869|Primary|Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment|Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.|At the time of surgery, after 24 weeks of preoperative treatment||||participants|||Number
1408046|NCT01194856|Secondary|Correlate the Changes in DEXA-measured Fat Limb With Fat mtDNA, mtRNA and Fat Apoptosis|A secondary objective of this trial will be to correlate the changes in DEXA-measured limb fat with those of fat mtDNA, mtRNA levels and fat apoptosis|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1408597|NCT01192139|Secondary|Metformin AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
1408048|NCT01194856|Secondary|Comparing Glucose Metabolism (Fasting Insulin, QUIKI and HOMA-IR) Between the Two Arms|To examine the effect of switching from EFV to ATV/r on glucose metabolism in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting insulin, QUIKI and HOMA-IR between the EFV arm and the ATV/r arm|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1408049|NCT01194856|Secondary|Comparing Fasting Lipid Levels Between the Two Arms|To examine the effect of switching from EFV to ATV/r on lipids in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fasting lipid levels between the EFV arm and ATV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1408050|NCT01194856|Secondary|Compare Changes in Fat mtDNA, mtRNA and Fat Apoptosis Between the Two Arms|To examine the effect of switching from EFV to ATV/r on fat mtDNA, mtRNA, and fat apoptosis in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in fat mtDNA, mt RNA levels and fat apoptosis between the EFV arm and ARV/r arm.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1408051|NCT01194856|Secondary|Compare Changes in CD4, HIV-1 RNA Levels and Adverse Events in Two Arms|To examine the effect of switching from EFV to ATV/r on safety in HIV-1 infected patients, a secondary objective of this trial will be to compare changes over 96 weeks in CD4 cell count, HIV-1 RNA levels, and adverse events between the EFV arm and the ATV/r arm|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1408052|NCT01194856|Secondary|Compare Changes for DEXA-measured Limb Fat Between EFV and ATV/r Arms|To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, a secondary objective of this trial will be to compare changes over 96 weeks in DEXA-measured limb fat between the EFV arm and ARV/r.|96 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1408053|NCT01194856|Primary|Change in DEXA-measured Limb Fat Between the EFV and ATV/r Arms|To examine the effect of switching from EFV- to ATV/r on limb fat in HIV-1 infected patients with established lipoatrophy, the primary objective of this trial will be to compare changes over 48 weeks in DEXA-measured limb fat between the EFV arm and ATV/r.|48 weeks|Data not collected for analysis due to low enrollment and participant discontinuation.||||||
1408054|NCT01194830|Secondary|Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks||baseline, 24 weeks|Meal Tolerance Test, observed cases data set (MTT-OC) includes all randomized patients who participated in the MTT sub-study. Patients required to have both baseline and on-treatment results.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
1408055|NCT01194830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks||baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
1408056|NCT01194830|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.|||Participants|||Number
1408057|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.|||Participants|||Number
1408058|NCT01194830|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication.|||Participants|||Number
1408059|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1408060|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1408061|NCT01194830|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1408062|NCT01194830|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1408063|NCT01194674|Secondary|Change in Retino-vascular Leakage, as Seen on Fluorescein Angiography (FA), at 4 Weeks vs. Baseline|"Retino-vascular leakage was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. For cases in which a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data."|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
1408214|NCT01193608|Other Pre-specified|CSF Amyloid-beta x-40 Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1408064|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 12 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 12 Weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
1408065|NCT01194674|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) at 4 Weeks vs. Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
1408066|NCT01194674|Secondary|Number of Participants Achieving Macular or Complete Posterior Vitreous Detachment (PVT) at 4 Weeks|This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
1408067|NCT01194674|Secondary|Change in Central Macular Thickness, as Measured by Optical Coherence Tomography (OCT), at 4 Weeks vs. Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.|Baseline and 4 weeks|This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.||||||
1408068|NCT01194674|Primary|Number of Non-ocular Adverse Events|The number of adverse events that were not eye-related was calculated.|24 weeks||||Adverse Events|||Number
1408069|NCT01194674|Primary|Number of Ocular Adverse Events|The number of eye-related adverse events was calculated.|24 weeks||||Adverse Events|||Number
1408070|NCT01194674|Primary|Number of Severe Adverse Events||24 weeks||||Adverse Events|||Number
1408071|NCT01194674|Primary|Number of Adverse Events||24 weeks||||Adverse Events|||Number
1408072|NCT01194570|Secondary|Percentage of Participants With at Least One Adverse Event (AE)|AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.|From the first infusion up to the study clinical cut-off date 24 July 2015 (up to 229 weeks)|The safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
1408073|NCT01194570|Secondary|Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120|The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0−100 score. The PCS score was computed by (a) multiplying each health domain z score by a scale-specific physical factor score coefficient, (b) summing the resulting products, (c) converting the product total to T score. The total score ranges from 0-100, higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|From Baseline to Week 120|ITT population included all randomized participants in the study. Here, Number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.|||units on a scale||95% Confidence Interval|Least Squares Mean
1408074|NCT01194570|Secondary|Percent Change in Total Brain Volume From Week 24 to Week 120||From Week 24 to Week 120|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint. Here, least square mean is indicating adjusted mean.|||percent change||95% Confidence Interval|Least Squares Mean
1408075|NCT01194570|Secondary|Percent Change From Baseline in Total Volume of T2 Lesions at Week 120||From Baseline to Week 120|ITT population included all randomized participants in the study. Here, Number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.|||percent change||95% Confidence Interval|Least Squares Mean
1408076|NCT01194570|Secondary|Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120||Baseline, Week 120|ITT population included all randomized participants in the study. Here, number of participants analyzed is the total participants who were evaluated for this endpoint. Here, least square mean is indicating adjusted geometric mean.|||percent change||95% Confidence Interval|Least Squares Mean
1408077|NCT01194570|Secondary|Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period|The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.|Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this endpoint.|||weeks||Full Range|Median
1408821|NCT01190306|Primary|Change in Corneal Curvature.||6 Months|The CXL-001 study was completed but data analysis was not done. Prior to data analysis, the sponsor, Topcon, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.||||||
1408078|NCT01194570|Primary|Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period|The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.|Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||weeks||Full Range|Median
1408079|NCT01194531|Primary|Implantation Rate|Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.|Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.|Patients who reached embryo transfer were included in this analysis.|||percentage of implantation per group|||Number
1408080|NCT01194479|Primary|Norepinephrine (pg/mL)|Norepinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.|||pg/mL||Standard Error|Mean
1408081|NCT01194479|Primary|Epinephrine (pg/mL)|Epinephrine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.|||pg/mL||Standard Error|Mean
1408082|NCT01194479|Secondary|Blood Glucose Levels (Average)|Blood glucose levels will be checked every 5 minutes during the 120 minute study session in order to maintain blood glucose levels in the normal and hypoglycemic range. Presented is the average of the collected values.|Up to 120 minutes|Subjects are pooled across randomized conditions in their respective study arms and reported overall.|||mg/dL||Standard Deviation|Mean
1408083|NCT01194479|Primary|Glucagon (pg/mL)|Glucagon levels will be measured throughout the study to assess whether there are changes during hypoglycemia with inhaled formoterol. These levels will be checked every 20 minutes during the 120 minute study session. Results are presented at the Basal, Euglycemia (30 minutes) and Hypoglycemia (105-120 minutes) stages.|up to 120 minutes|Results are pooled at the arm level and split by placebo and control regardless of randomization order.|||pg/mL||Standard Error|Mean
1408084|NCT01194453|Secondary|Response Rate||6 weeks||||percentage|||Number
1408085|NCT01194453|Primary|Progression Free Survival (PFS)||36months||||day||95% Confidence Interval|Median
1408086|NCT01194440|Secondary|Number of Patients Who Discontinue or Change Aromatase Inhibitory (AI) Therapy||12 months|||||||
1408087|NCT01194440|Secondary|Visual Analog Scale||12 months|||||||
1408088|NCT01194440|Secondary|Health Assessment Questionnaire Disability Index||12 months|||||||
1408089|NCT01194440|Primary|Frequency of Women With Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)|The primary hypothesis of the study is that given zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS as compared to patients receiving letrozole alone. The number of women experiencing AIMSS in this study is compared to the results from a prior published study of women receiving letrozole alone.|12 months||||Participants|||Count of Participants
1408090|NCT01194427|Primary|Changes in Markers of Proliferation Prior to and After Study Drug Administration|To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.|Baseline and 14 days|Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report.||||||
1408091|NCT01194414|Secondary|Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97||Week 97|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Here, 'n' indicates number of subjects in the safety population tested by screening assay at any time point.|||percentage of participants|||Number
1408092|NCT01194414|Secondary|Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97||Baseline, Week 97|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1408093|NCT01194414|Secondary|Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25||Baseline, Week 25|The ITT-PK population includes all participants who were eligible for the ITT population and provided at least 1 evaluable PK sample in the double blind or open label periods. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1408094|NCT01194414|Secondary|Time to Maximum Serum Concentration (Tmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||hour (hr)||Full Range|Median
1408822|NCT01190306|Primary|Changes in Corneal Curvature||6MO|||||||
1408095|NCT01194414|Secondary|Maximum Serum Concentration (Cmax) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||mcg/mL||Standard Deviation|Mean
1408096|NCT01194414|Secondary|Minimum Serum Concentration (Cmin) of Tocilizumab||Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the PK analysis. Here, number of participants analyzed who were evaluable for this outcome measure and ‘n’ indicates number of participants who were evaluated at specified time point.|||micrgram/milliliter (mcg/mL)||Standard Deviation|Mean
1408097|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment||Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.|||μg*hr/mL||Standard Deviation|Mean
1408098|NCT01194414|Secondary|Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion||Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose|Pharmacokinetic-Evaluable Population included all participants who provided at least one evaluable PK sample were included in the pharmacokinetic analysis (PK) analysis. Here, number of participants analyzed who were evaluable for this outcome measure.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
1408099|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug.|||percentage of participants|||Number
1408100|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.|Baseline, Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.|||percentage of participants|||Number
1408101|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.|Week 97|ITT Population included all participants who completed double blind period and were re-randomized at Week 24 and received at least one dose of study drug. If ESR=0 then ESR=1 is substituted into the DAS28 calculation to enable a non-missing DAS28 score. Here, number of participants analyzed is the participants for whom parameter was collected.|||percentage of participants|||Number
1408102|NCT01194414|Secondary|Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97|ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.|Week 97|Re-Randomized Intent-to-Treat Population (ITT Population) included all participants who completed double blind period and were re-randomized at Week 24, received at least 1 dose of study drug. Here, number of participants analyzed is the participants for whom parameter was collected.|||percentage of participants|||Number
1408103|NCT01194414|Secondary|Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24|The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.|24 Weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations.|||Percentage of participants|||Number
1408112|NCT01194258|Secondary|Mean Daily PPG Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily PPG excursions during 10-point glucose monitoring for breakfast, lunch, and dinner from Treatment Period 1 or Treatment Period 2 are presented. PPG refers to the change in glucose concentration before to after a meal. Data were collected 1 and 2 hours (hr) after each meal. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (insulin lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Period 1 and Period 2 with evaluable PPG excursion data.|||mg/dL||Standard Deviation|Mean
1409156|NCT01188460|Primary|Sleep Diary- Sleep Efficiency|"Measures:~Sleep Efficiency (percentage)- higher scores indicate better outcomes"|Timepoint 2 (week 7 of study participation).||||Percentage of efficiency||Standard Deviation|Mean
1408104|NCT01194414|Secondary|Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.|Baseline, 24 Weeks|Participants from the Per Protocol Population (all randomized participants who received study drug and had no major protocol violations) with data available for analysis. No imputation of missing scores will be made other than for missing baseline scores, for which last score prior to defined protocol baseline time window will be carried forward.|||Percentage of participants|||Number
1408105|NCT01194414|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24|The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.|Week 24|Participants from the Per Protocol Population (randomized participants who received study drug and had no major protocol violations) with data available for analysis. Missing SJC and TJC will be imputed using the last post-baseline value for the patient (LOCF). No imputation for missing ESR or patient’s global assessment of disease activity.|||Percentage of participants|||Number
1408106|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.|||Percentage of participants|||Number
1408107|NCT01194414|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.|||Percentage of participants|||Number
1408108|NCT01194414|Primary|Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments||Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)|The safety population includes all participants who received at least one dose of study drug, whether re-randomized or not, and who had at least one post-dose safety assessment. Data are included from double blind and open label (OL) periods in the SC and IV arms but only from the OL period in IV-SC and SC-IV switch arms.|||percentage of participants|||Number
1408109|NCT01194414|Primary|Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]).|Baseline, 24 weeks|Per Protocol Population included all randomized participants who received study drug and had no major protocol violations. Last Observation Carried Forward was used for missing joint counts, no imputation for other ACR components. CRP will be used primarily for calculation of the ACR response. If missing, the ESR will be used for that participant.|||Percentage of participants||95% Confidence Interval|Number
1408110|NCT01194297|Secondary|Medically-attended Wheezing|Wheezing that triggers a visit for medical care|42 days|Total N|||participants|||Number
1408111|NCT01194297|Primary|Humoral Immunogenicity|Hemagglutinin specific antibody, as measured by hemagglutination inhibition|28-42 days|||||||
1409157|NCT01188460|Primary|Sleep Diary- Number of Nocturnal Awakenings|"Measures:~Number of Nocturnal Awakenings, higher scores indicate worse outcomes"|Timepoint 2 (week 7 of study participation).||||Number of nocturnal awakenings||Standard Deviation|Mean
1408113|NCT01194258|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Change from baseline in body weight at the end of each treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both cohorts).|Baseline, Week 12 and Week 24|All participants who completed both Period 1 and Period 2 with evaluable body weight data.|||pounds||Standard Deviation|Mean
1408114|NCT01194258|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|The rate of hypoglycemia, defined as blood glucose levels ≤70 mg/dL and <56 mg/dL, was calculated based on 4 weeks of observation prior to the end of treatment period (that is, Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2.|||Events per participant per month|||Number
1408115|NCT01194258|Secondary|Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values was recorded during non-10-point glucose monitoring was recorded. The number of participants was recorded, and the percentage of participants meeting glucose targets was calculated by the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants in Treatment Period 1 or Treatment Period 2 who received at least 1 dose of study drug and had evaluable postprandial blood glucose data.|||Percentage of participants|||Number
1408116|NCT01194258|Secondary|Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring|Mean daily insulin dose as recorded during 10-point glucose monitoring is reported. Blood glucose values were obtained during a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2) at the following timepoints: immediately prior to breakfast (fasting), 1 hour (hr) after breakfast, 2 hr after breakfast, immediately prior to lunch, 1 hr after lunch, 2 hr after lunch, immediately prior to dinner, 1 hr after dinner, 2 hr after dinner, and at 03:00. A minimum of 7 determinations were required for each day during the 3 days of 10-point glucose profiles. Prandial insulin doses were also recorded during the 10-point glucose monitoring and the mean daily insulin dose over the 3 days was calculated. Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable insulin dosing data.|||units of Insulin||Standard Deviation|Mean
1408117|NCT01194258|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period|Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|All participants who completed both Treatment Period 1 and Treatment Period 2 with evaluable HbA1C data.|||percentage of HbA1C||Standard Deviation|Mean
1408118|NCT01194245|Secondary|Mean Daily Postprandial Glucose (PPG) Excursions|Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose (PPG) excursion data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1408119|NCT01194245|Secondary|Change From Baseline in Body Weight at the End of Each Treatment Period|Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable body weight data.|||pounds (lbs)||Standard Deviation|Mean
1408120|NCT01194245|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period|Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.|Baseline, Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable hemoglobin A1C data.|||percentage of hemoglobin A1C||Standard Deviation|Mean
1408121|NCT01194245|Secondary|Rates of Hypoglycemia at the End of Each Treatment Period|Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Week 12 and Week 24|Participants who completed both Treatment Period 1 and Treatment Period 2.|||events per participant per month|||Number
1409016|NCT01189292|Secondary|Degree of Post Operative Nausea and Vomiting|"mild nausea:......single administration of an antiemetic drug~severe nausea: repeated administration of antiemetic drugs~vomiting:...........at least one vomiting event"|4 hours after surgery|intention to treat|||participants|||Number
1408122|NCT01194245|Secondary|Percentage of Participants Meeting Glucose Targets|Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Baseline through Week 24, excluding 10-point glucose monitoring days|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose data.|||percentage of participants|||Number
1408123|NCT01194245|Secondary|Mean Daily Insulin Dose|Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).|Week 10 and Week 22|Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable insulin dose data.|||units (U)||Standard Deviation|Mean
1408124|NCT01194219|Secondary|Number of Participants With a Psoriasis Flare or Rebound During the During the Apremilast-exposure Period Through Week 260|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Week 0 to Week 260|Safety population consisted of all participants who were randomized and received at least one dose of IP; apremilast participants as treated|||participants|||Number
1408125|NCT01194219|Secondary|Number of Participants With a Psoriasis Flare or Rebound During the Placebo-Controlled Phase|Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].|Weeks 0 to Week 16|Included all participants who were randomized and received at least one dose of Investigational Product (IP).|||participants|||Number
1408126|NCT01194219|Secondary|Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260|The Apremilast-exposure Period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. Adverse events that started after 28 days of initiating placebo and before resuming apremilast treatment in the Randomized Treatment Withdrawal Phase (Weeks 32 to 52) were excluded in the Apremilast-exposure Period. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 260; mean exposure to apremilast 30 mg BID during the Apremilast-exposure Period up to Week 260 was 97.83 weeks|The apremilast subjects as treated population, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.|||participants|||Number
1408127|NCT01194219|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16; mean duration of exposure was 14.8 weeks and 15.0 weeks for subjects randomized to placebo and apremilast respectively.|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)|||participants|||Number
1408128|NCT01194219|Secondary|Kaplan Meier Estimate of Time to Loss of PASI-75 Response (Loss of Effect) at Week 32 During the Re-Randomized Treatment Withdrawal Phase|Time to loss was the time between the re-randomization date and the date of the first assessment where loss of PASI-75 was observed (event); or the time between the re-randomization date and the date of the last PASI assessment in the Weeks 32-52 interval prior to addition of protocol-prohibited medication/therapy, or resumption of APR 30 BID, or discontinuation, or Week 52 if no loss (censored).|Week 32 to Week 52|Analysis population consisted of participants who were re-randomized to placebo or apremilast 30mg BID at Week 32.|||Weeks||95% Confidence Interval|Median
1408129|NCT01194219|Secondary|Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline|PASI-75 response was the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. See Outcome Measure #1 for further description. sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See OCM #2 for further description.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
1408130|NCT01194219|Secondary|Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
1408131|NCT01194219|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant’s skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from “Very Much” (score 3) to “Not at All” or “Not relevant” (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant’s skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if “No,” then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being “A lot,” “A little,” or “Not at all” (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included|||units on a scale||Standard Error|Least Squares Mean
1408132|NCT01194219|Secondary|Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16|The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value − baseline value.|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included.|||units on a scale||Standard Error|Least Squares Mean
1408133|NCT01194219|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline|A participant was classified as having at least a 50% improvement in PASI score from baseline, which was equivalent to a percent change from baseline ranging from −100% to −50%. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||Percentage of Participants|||Number
1408134|NCT01194219|Secondary|Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16|Psoriasis Area Severity Index (PASI) scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing. PASI score percent change from baseline was calculated as 100* (visit score – baseline score)/baseline score (%).|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used. Participants with a baseline value and at least 1 postbaseline value are included .|||percent change||Standard Error|Least Squares Mean
1408215|NCT01193608|Other Pre-specified|Change From Baseline in CSF Amyloid-beta x-40 Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1408135|NCT01194219|Secondary|Percent Change From Baseline in Percent of Affected Body Surface Area (BSA) at Week 16|BSA was a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant’s hand (entire palmar surface or “handprint” including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA – baseline BSA) / baseline BSA (%).|Baseline and Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Participants with a baseline value and at least 1 postbaseline value were included. Last observation carried forward imputation was used.|||percent change||Standard Error|Least Squares Mean
1408136|NCT01194219|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With At Least 2 Points Reduction From Baseline|The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator factored in areas that have already been cleared (ie, have scores of 0) and did not just evaluate remaining lesions for severity, ie, the severity of each sign was averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward imputation was used.|||percentage of participants|||Number
1408137|NCT01194219|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|The Full Analysis Set (FAS) consisted of all participants who were randomized per protocol. Participants were included in the treatment group to which they were randomized APR 30 BID or placebo for the FAS. Last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
1408138|NCT01194154|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|24 months|The Safety Analysis Set (SAF) included all participants who received at least one dose of study medication. Analysis for SAF was performed according to the study medication actually received (as treated population). Number of participants analyzed=participants evaluable for this measure.|||percentage of participants|||Number
1408139|NCT01194154|Secondary|Change From Baseline in Serum Cystatin C Concentration at Month 24|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.|||mg/L||Standard Deviation|Mean
1408140|NCT01194154|Secondary|Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24|UACR is defined as the ratio: milligram of albumin per gram of creatinine. The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Number of Participants Analyzed (N) = number of participants evaluable and available with valid data for this outcome measure. Here, n=number of participants evaluable for each category.|||mg/g||Standard Deviation|Mean
1408141|NCT01194154|Secondary|Change From Baseline in Serum Creatinine Concentration at Month 24|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.|||mcmol/L||Standard Deviation|Mean
1408142|NCT01194154|Secondary|Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24|Creatinine clearance was calculated according to the Cockcroft and Gault Formula. It measures rate creatinine (substance formed from metabolism of creatine) is cleared from blood by kidneys. Normal adult creatinine clearance is greater than or equal to (>=) 90 mL/min. Change from baseline=CC at Week X minus CC at baseline where higher scores represented improved renal function.|Baseline, Month 24|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement. Here, n=number of participants evaluable for each category.|||mL/min||Standard Deviation|Mean
1408242|NCT01193608|Primary|Maximum Observed Serum Concentration (Cmax) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Pharmacokinetic (PK) Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1408143|NCT01194154|Secondary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)|The eGFR value calculated using the CKD-EPI equation. The formula used is based on age, sex, ethnicity, and serum creatinine and eGFR values are calculated as follows: GFR in mL/min per 1.73 m^2 = 141 x min (SerumCr/k; 1)^a x max(SerumCr/k; 1)^(-1.209) x 0.993^age x F x B, where k=0.7 for female (else=0.9); a=-0.329 for female (else=-0.411), F=1.018 for female (else=1), B=1.159 for black (else=1), min/max=minimum/maximum of listed values. The Yearly Reduction Rate (mL/min/1.73m^2 / Year) is defined as –365.25 x Beta, where Beta is the slope parameter derived for each participant separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.|||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
1408144|NCT01194154|Primary|Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4)|The yearly reduction in eGFR was calculated using the MDRD-4 formula. This formula is based on age, sex, and serum creatinine and eGFR values are calculated as follows: GFR in milliliter per minute (mL/min) per 1.73 meter square (m^2) = 175 x Serum Cr^-1.154 x age^-0.203 x 0.742 (if female). The yearly reduction rate (mL/min/1.73m^2 / Year) is defined as –365.25 multiplied by Beta, where Beta is the slope parameter derived for each participants separately by simple linear regression of the change from baseline in participant's eGFR measurements (from Baseline to Visit 24) on the actual day of measurement.|24 months|FAS included all randomized participants who received at least one dose of the study medication and provided any successive eGFR measurement.|||mL/min/1.73m^2/year||95% Confidence Interval|Least Squares Mean
1408145|NCT01194089|Secondary|Numeric Pain Score|Upon arrival in the PACU and at least every 30 minutes thereafter while in the PACU, the subject was asked to report pain using a numerical pain score for current pain at rest from 0 (representing no pain) to 10 (representing the worst imaginable pain).|on admission, 30 minutes, 60 minutes, at discharge|Not all participants completed the pain scale at every time point. The participants analyzed per arm (nicotine, normal) at each time point were: on admission (40, 45); 30 minutes (40, 47); 60 minutes (34, 40); at discharge (39, 44),|||units on a scale||Inter-Quartile Range|Median
1408146|NCT01194089|Secondary|Number of Participants Who Needed to Use Antiemetic Medication in the PACU|Rescue antiemetic therapy was 0.625 mg droperidol. Recalcitrant postoperative pain, nausea and vomiting (PONV) was treated per discretion of the supervising anesthesiologist.|24 hours postoperatively.||||participants|||Number
1408147|NCT01194089|Primary|Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively|Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.|During PACU stay (approximately 94 minutes after operation), 24 hours after operation||||mg||Inter-Quartile Range|Median
1408148|NCT01193920|Secondary|Number of Infants Reporting Serious Adverse Events|Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events|one year after birth||||Number of subjects|||Number
1408149|NCT01193920|Secondary|Antibody GMC Per Serotype at Different Time Points in Infants|Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.|Day 4, day 43 and day 91 after birth|Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames|||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
1408150|NCT01193920|Secondary|Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events|Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.|From day 1 to one year after delivery|Safety set, solicited and unsolicited reactogenicity, maternal subjects|||participants|||Number
1408151|NCT01193920|Secondary|Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events|Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.|Day 61|Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects|||participants|||Number
1408152|NCT01193920|Secondary|Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination|Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects|||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
1408153|NCT01193920|Secondary|The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.|The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.|Day 361, one year after the first vaccination|FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361.|||percentage of subjects||95% Confidence Interval|Number
1408154|NCT01193920|Secondary|Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination|Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.|day 31|FAS, secondary, maternal subjects, day 31|||concentration (μg/mL)||95% Confidence Interval|Geometric Mean
1408155|NCT01193920|Primary|Antibody GMC in Maternal Subjects at Day of Delivery|Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.|Day of delivery|FAS primary, maternal subjects|||Concentration (μg/mL)||95% Confidence Interval|Geometric Mean
1409031|NCT01189227|Secondary|Frequencies of Selected Postoperative Surgical Complications and Other Adverse Events Within 30 Days of Surgery||Assessed within 30 days from the time of surgery|||||||
1408156|NCT01193920|Primary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day of delivery|FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery|||percentage of subjects||95% Confidence Interval|Number
1408157|NCT01193920|Secondary|The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.|The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 31, one month after vaccination|FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31|||percentage of subjects||95% Confidence Interval|Number
1408158|NCT01193920|Primary|Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.|Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .|Day 61, one month after the second vaccination|FAS - primary, non-pregnant subjects|||concentrations (μg/mL)||95% Confidence Interval|Geometric Mean
1408159|NCT01193920|Primary|The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.|The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.|Day 61, one month after the second vaccination|Full Analysis Set (FAS) – primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61|||percentage of subjects||95% Confidence Interval|Number
1408160|NCT01193907|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 28 days after vaccination||||percentage of subjects||95% Confidence Interval|Number
1408161|NCT01193907|Primary|Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)||At 28 days after vaccination||||GMC||95% Confidence Interval|Mean
1408162|NCT01193907|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination||||participants|||Number
1408163|NCT01193907|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue|During the 7-day period after vaccination||||participants|||Number
1408164|NCT01193868|Secondary|Progression-free Survival|Time from initiation of study drug until death, progression of tumor, or for worsening of tumor that did not meet RECIST 1.1 criteria but that did require discontinuation of therapy, assessed up to 5 years|Baseline up to 5 years|Study terminated early. Analysis not performed due to small numbers.||||||
1408165|NCT01193868|Secondary|Correlation of Tumor Shrinkage/Response With Biomarker Expression|Correlate percent change in tumor size at 6 weeks (or at time off study, if therapy is stopped earlier due to tumor progression) with tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers; Tumor % shrinkage with RO4929097 will correlate with pre-therapy tumor expression of Notch pathway members, with expression of stem cell markers, and with changes in these over the first cycle of therapy.|6 weeks|Study terminated early. Analysis not performed due to small numbers.||||||
1408166|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Tumor Progression|Tumor Immunohistochemistry (IHC) scores for Notch pathway and stem cell markers used in comparison to tumor progression; and progression evaluated in using international criteria proposed by revised RECIST guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests.|Up to 3 months|Study terminated early with low accrual leading to insufficient data for analysis.||||||
1408167|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Response by RECIST Criteria|Wilcoxon rank sum tests will be used.|Up to day 3|Study terminated early. Analysis not performed due to small numbers.||||||
1408168|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With vs Without Epidermal Growth Factor Receptor (EGFR) Activating Mutations|Wilcoxon rank sum tests will be used. Compared using Fisher Exact Tests. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Sum Test). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.||||||
1408169|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in Participants With Versus Without a Particular Host Genotype Polymorphism|Wilcoxon rank sum tests will be used. For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests).|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.||||||
1408195|NCT01193660|Primary|Changes in Standardized Gross Motor Function|GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408170|NCT01193868|Secondary|Proportion of Tumors Expressing the Expression of Tumor Notch Markers and Stem Cell Markers of Interest in This Population vs Tumor Bank Population|For participants having biopsies both before and after the agent, paired comparisons of post-therapy to pre-therapy results for the Notch IHC scores will be used. Researchers will assess changes from pre-therapy to post-therapy using a Wilcoxon Signed Rank Test (Wilcoxon rank sum tests). Spearman coefficients will be used to correlate tumor expression of Notch pathway markers with expression of stem cell markers.|Up to day 3|Study terminated early with low accrual leading to insufficient data for analysis.||||||
1408171|NCT01193868|Primary|Percentage of Tumor Shrinkage as a Continuous Variable|Response is reported as a continuous variable, as % change in tumor size from baseline. Pearson and Spearman correlation coefficients will be used. Reported with 95% two-sided confidence intervals.|6 weeks|Study terminated early with low accrual leading to insufficient data for analysis.||||||
1408172|NCT01193868|Primary|Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with response per RECIST version 1.1: Complete Response (CR):Disappearance all target lesions. Any pathological lymph nodes with reduction in short axis to <10 mm. Partial Response (PR): At least 30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): At least 20% increase in sum of diameters of target lesions, reference smallest sum on study (includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must demonstrate an absolute increase of at least 5 mm. (Note: appearance of 1 or more new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Best response recorded from treatment start until disease progression/recurrence (reference for progressive disease the smallest measurements recorded since treatment started).|Response evaluation every 6 weeks (in addition to baseline scan, confirmatory scans approximately 6-7 (not less than 4) weeks following initial documentation of objective response). Expected follow up to 5 years, actual study period 9/2010 to 4/2014.|Only those participants who have measurable disease present at baseline and received at least one dose of study medication considered evaluable for response with their response classified according to the RECIST definitions stated. Participants who exhibit objective disease progression prior to the end of cycle 1 also considered evaluable.|||percentage of participants|||Number
1408173|NCT01193842|Secondary|Tumor Response (Phase I)|The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease|Up to 2 years post treatment|Eligible participants who completed at least 1 cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
1408174|NCT01193842|Secondary|Pharmacokinetic Clearance (Phase I)|Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points.|24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion|Phase I participants with evaluable pharmacokinetic data|||Liter/hour||Standard Deviation|Mean
1408175|NCT01193842|Secondary|Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)|Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.|Baseline up to 12 months|Eligible participants who returned for follow-up with evaluable data.|||copies per milliliter||Inter-Quartile Range|Median
1408176|NCT01193842|Secondary|Overall Survival (OS) (Phase II)|The percentage of participants surviving one year after starting treatment.|1 year|Eligible randomized participants.|||percentage of participants||95% Confidence Interval|Number
1408177|NCT01193842|Secondary|Event-free Survival (EFS) (Phase II)|The percentage of participants surviving without events (relapse or death) one year after starting treatment.|1 year|Eligible randomized participants.|||percentage of participants||95% Confidence Interval|Number
1408178|NCT01193842|Secondary|Changes in Human Immunodeficiency Virus (HIV) Viral Load|Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.|Baseline up to 12 months|Phase II participants who returned for follow-up with evaluable data.|||copies per milliliter||Inter-Quartile Range|Median
1408179|NCT01193842|Secondary|Changes in Human Herpes Virus (HHV)-8 Viral Load|Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.|Baseline up to 12 months||2018-06-30|06/2018||||
1408180|NCT01193842|Secondary|Changes in Epstein-Barr Virus (EBV) Viral Load|Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load.|Baseline up to 12 months||2018-06-30|06/2018||||
1408181|NCT01193842|Secondary|Changes in Absolute CD4 Cell Counts (Phase I)|Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts.|Baseline up to 12 months|Eligible participants who completed at least 1 cycle of treatment with evaluable data.|||cell/mm^3||Inter-Quartile Range|Median
1408182|NCT01193842|Secondary|Change in CD8 Cell Counts (Phase I)|Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts.|Baseline up to 12 months|Eligible participants who returned for follow-up with evaluable data.|||cells/mm^3||Inter-Quartile Range|Median
1408208|NCT01193608|Other Pre-specified|CSF P-tau Concentration at Baseline and Week 32 for AAB-003 2 mg/kg and 4 mg/kg Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
1408183|NCT01193842|Primary|Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)|Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.|21 days|Eligible Phase I Arm A (VR-DA-EPOCH) participants who completed at least 1 cycle of treatment. This arm includes participants treated at 300 mg once a day (n=6) or 400 mg once a day (n=6) of Vorinostat for days 1-5.|||Mg per day of Vorinostat|||Number
1408184|NCT01193842|Primary|Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)|The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.|Up to 5 years|Eligible randomized participants|||percentage of participants|||Number
1408185|NCT01193842|Primary|Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)|Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.|Up to 6 months|Reviewed responses from participants who completed at least one cycle of treatment.|||percentage of participants||95% Confidence Interval|Number
1408186|NCT01193686|Secondary|General Anger Level|5-item scale developed for this study. Assesses level of perceived experienced anger in the past month. Possible scores range from 5-35 with higher scores indicating greater levels of anger.|Post- Participation|This measure was only administered to Recipients of Peer Visits.|||units on a scale||Full Range|Mean
1408187|NCT01193686|Secondary|Patient Activation Measure|Measures participante self-efficacy, knowledge of and engagement in health care. Possible scores range from 13-52 with higher scores indicating greater efficacy/knowledge/engagement.|Post- Participation|This measure was only administered to Recipients of Peer Visitation.|||units on a scale||Full Range|Mean
1408188|NCT01193686|Secondary|Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)|Measures PTSD symptoms. Possible scores range from 19-95, with higher scores indicating greater symptom severity.|Upon study completion.||||units on a scale||Full Range|Mean
1408189|NCT01193686|Secondary|Patient Health Questionnaire-9 (Depression Screen)|9-item depression screen with possible response options ranging from 9-36, with higher numbers indicating greater depression symptom severity.|Upon completion of visits.||||units on a scale||Full Range|Mean
1408190|NCT01193686|Primary|Post Traumatic Growth Inventory|Administered only to Peer Visitors, possible range 0-105, with higher scores indicating greater post-traumatic growth. Post-traumatic growth includes emotional changes such as noticing a stronger sense of self, deepened relationships, increased sense of gratitude or appreciation for life, increased spirituality.|Upon completion of study requirements (i.e., visits)|This measure was only administered to Veteran Peer Visitors.|||units on a scale||Full Range|Mean
1408191|NCT01193660|Secondary|Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant|The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.|6 months||||participants|||Number
1408192|NCT01193660|Secondary|Changes in Hand Function|QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408193|NCT01193660|Secondary|Changes in Muscle Strength|Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408194|NCT01193660|Secondary|Changes in Functional Independence in Daily Activities|WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408209|NCT01193608|Other Pre-specified|Change From Baseline in CSF P-tau Concentration at Week 32 for AAB-003 8 mg/kg and Placebo Groups||Baseline and Week 32|The CSF analysis set consisted of participants in the AAB-003 8 mg/kg cohort who had provided sufficient CSF samples at Baseline and Week 32 to allow for assaying of both samples, and who had no occurrence of VE.|||pg/mL||Standard Deviation|Mean
1408196|NCT01193660|Secondary|Changes in Functional Performance in Daily Activities|Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.|Baseline -1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408197|NCT01193660|Secondary|Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism|"18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that 1 refers to INCREASED areas, -1, DECREASED areas and 0, just NO CHANGE."|Baseline - 2 weeks|Intention to treat|||units on a scale|||Number
1408198|NCT01193660|Secondary|Changes in Brain MRI|Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.|Baseline - 6 months||||units on a scale||Standard Error|Mean
1408199|NCT01193660|Secondary|Changes in Motor Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline - 1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408200|NCT01193660|Secondary|Changes in Cognitive Neurodevelopmental Outcome|Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408201|NCT01193660|Primary|Changes in Motor Performance|GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.|Baseline -1 month - 3 months - 6 months|Intention to treat|||units on a scale||Standard Error|Mean
1408202|NCT01193608|Other Pre-specified|Plasma Decay Half-Life (t1/2) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for t1/2. No participants had available data for t1/2 in AAB-003 8 mg/kg and Placebo Groups.|||Day||Standard Deviation|Mean
1408203|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1408204|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUCinf. No participants had available data for AUCinf in AAB-003 8 mg/kg and Placebo Groups.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1408205|NCT01193608|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Amyloid-Beta x-40||Baseline; Day 2 (24 hours post start of infusion); Weeks 1, 6, and 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment, at least one post-dose PD parameter assessment, and who had available data for AUClast.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1408206|NCT01193608|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication, had a Baseline PD parameter assessment and at least one post-dose PD parameter assessment. n = number of evaluable participants at the corresponding timeframe.|||Hours||Full Range|Median
1408207|NCT01193608|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) for Amyloid-Beta x-40||Weeks 1, 3, 6, 10, 13 (pre-dose, 1 hour [end of infusion]), Week 26 (pre-dose, 1 hour [end of infusion], 1.5, 2, 4, 6, and 24 hours post start of infusion), and Weeks 32 and 39.|All randomized participants who received at least one infusion of study medication and have at least one postdose pharmacodynamic (PD) parameter assessment. n = number of evaluable participants at the corresponding timeframe.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1408216|NCT01193608|Other Pre-specified|Cerebrospinal Fluid (CSF) Concentration of AAB-003 at Week 32|Participants enrolled in the 2, 4 and 8 mg/kg cohorts participated in an optional CSF collection. Participants enrolled in the maximum tolerated dose (MTD) cohort were mandatorily collected for CSF.|Week 32 or Early Withdrawal|All randomized and treated participants in the 2, 4 and 8 mg/kg cohorts who consented to the collection of CSF samples.|||nanogram/millliter (ng/mL)||Standard Deviation|Mean
1408217|NCT01193608|Other Pre-specified|Change From Baseline on the Mini Mental State Exam (MMSE) Score at Weeks 13, 26, and 39|The MMSE is a brief 30-point questionnaire test that is used to assess cognition. It is commonly used to screen for dementia. In the time span of about 10 min, it samples various functions, including arithmetic, memory and orientation. Scores range from 0 to 30 (higher scores indicate less impairment) and participants with scores of 16 to 26 were eligible.|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
1408218|NCT01193608|Other Pre-specified|Change From Baseline on the Clinical Dementia Rating (CDR) Sum of Boxes (CDR-SB) and Global CDR Rating at Weeks 26 and 39|The CDR scale is a clinician-rated dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories – memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care based on the CDR interview. The CDR is based on discussions between the clinician with the participant and caregiver using a structured format. A global CDR score is established by clinical scoring rules with values of 0 (no dementia), 0.5 (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). A more quantitative version of the CDR scale is obtained by summing up the ratings in each of the 6 categories to provide the (CDR-SB). The CDR-SB scale ranges from 0 to 18 where higher score indicates severe dementia.|Baseline, Weeks 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
1408219|NCT01193608|Other Pre-specified|Change From Baseline in Behavioral Symtoms as Measured by the Neuropsychiatric Inventory (NPI) at Weeks 13, 26 and 39|The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in participants with Alzheimer's disease (AD) and other dementias. Twelve (12) behavioral areas are assessed in the NPI – delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories as reported by the caregiver. A separate caregiver distress score may also be included. The NPI ranges from 0 to 144 (higher scores indicate greater psychopathology).|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
1408220|NCT01193608|Other Pre-specified|Change From Baseline in Disability Assessment in Dementia (DAD) Score at Weeks 13, 26 and 39|The DAD is a functional assessment based on an interview with the caregiver that takes approximately 20 min to administer and it is comprised of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. The DAD is scored from 0 to 100 (higher scores indicate better functioning).|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
1408221|NCT01193608|Other Pre-specified|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) Score at Weeks 13, 26 and 39|The ADAS-cog 70 Point is a structured scale (approximately 40 min to complete) that evaluates memory, orientation, attention, reasoning, language and constructional praxis. This study used the 11-item cognitive subscale of the ADAS-Cog with scores ranging from 0 to 70 points; higher scores indicated greater cognitive impairment.|Baseline, Weeks 13, 26 and 39|All participants who were randomized to a treatment and received at least one infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Units on a scale||Standard Deviation|Mean
1408222|NCT01193608|Other Pre-specified|Number of Participants With Positive Anti-product Antibody Response to AAB-003 in Serum|Human serum anti-drug antibodies (ADA) samples were analyzed for the presence or absence of anti-AAB-003 antibodies by enzyme-linked immunosorbent assay (ELISA) method|Day 1 (predose), Week 13 (predose), Week 26 (predose) and Week 39 or Early Withdrawal|All participants who received an infusion of study medication. n = number of evaluable participants at the corresponding timeframe.|||Participants|||Number
1408223|NCT01193608|Primary|Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarization Criteria|Criteria for ECG values of potential clinical concern are: interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between onset of atrial depolarization and onset of ventricular depolarization (PR): >= 300 milliseconds (msec), and >=25% increase when baseline >=200 msec/ >=50% increase when baseline less than or equal to (<=) 200 msec; time from ECG Q wave to the end of S wave corresponding to ventricular depolarization (QRS): >=200 msec, and >=25% increase when baseline >100 msec/ >=50% increase when baseline <=100 msec; QTc using Fridericia's formula (QTcF) interval: 450 to <480 msec, >=480 msec; QTcF change from baseline: 30 to <60 msec, and >=60 msec.|Baseline, Weeks 1,13,16,26,39 or Early Withdrawal|Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).|||Participants|||Number
1408224|NCT01193608|Primary|Number of Participants With Vasogenic Edema of All Severity After Each Infusion Visit|VE of the brain, identified via MRI, was identified as an adverse event of special circumstance.|Day 1, Week 13, and Week 26|Safety Analysis Set included all participants who received an infusion of study medication, including partial infusions. n = number of evaluable participants at the corresponding timeframe.|||Participants|||Number
1408225|NCT01193608|Primary|Number of Participants With New Occurrence of Brain Magnetic Resonance Imaging (MRI) Finding|Brain MRIs were collected during the course of study to assess for any potential drug-related changes that might have constituted a safety concern for study participants. Findings suggestive of either vasogenic edema (VE) or intracranial hemorrhage represented adverse events of special circumstance and were to be reported immediately.|Baseline up to Week 32.|Safety Analysis Set included all participants who received an infusion of study medication (including partial infusions).|||Participants|||Number
1408226|NCT01193608|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS assessed whether the participant experienced the following: completed suicide (1), suicide attempt (2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline up to Week 39 or Early Withdrawal|Safety Analysis Set included all participants who received at least one infusion of study medication (including partial infusions).|||Participants|||Number
1408227|NCT01193608|Primary|Serum Decay Half-Life (t1/2) for AAB-003 at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||Days||Standard Deviation|Mean
1408228|NCT01193608|Primary|Serum Decay Half-Life (t1/2) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||Days||Standard Deviation|Mean
1408229|NCT01193608|Primary|Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1408230|NCT01193608|Primary|Volume of Distribution at Steady State (Vss) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1408231|NCT01193608|Primary|Systemic Clearance (CL) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
1408232|NCT01193608|Primary|Systemic Clearance (CL) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||milliliter/hour/kilogram (mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
1408233|NCT01193608|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1408234|NCT01193608|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1408235|NCT01193608|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1408236|NCT01193608|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1408237|NCT01193608|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||Hours (hr)||Full Range|Median
1408238|NCT01193608|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax) for AAB-003 at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|PK Analysis Set consisted of all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment.|||Hours (hr)||Full Range|Median
1408239|NCT01193608|Primary|Average Concentration (Cavg) for AAB-003 in Serum at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1408240|NCT01193608|Primary|Average Concentration (Cavg) for AAB-003 in Serum at Day 1||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4 and 6 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1408241|NCT01193608|Primary|Maximum Observed Serum Concentration (Cmax) for AAB-003 at at Week 26||Pre-dose, 1 hour (end of infusion), 1.5, 2, 4, 6, and 24 hours post start of infusion.|Evaluable participants in the PK analysis set (all randomized participants who received at least one infusion of study medication and have at least one post-dose PK parameter assessment).|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1408243|NCT01193608|Primary|Number of Participants With Abnormal Neurological Examination Findings|The neurological examination was done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator. The minimum items assessed were level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes.|Screening, Day 1 (Baseline) and Weeks 1,6,13,19,26,32, and 39, and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). n = number of evaluable participants at the corresponding time point.|||Participants|||Number
1408244|NCT01193608|Primary|Number of Participants With Abnormal Physical Examination Findings||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A full physical examination consisted of abdomen, genitourinary, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal, general, skin, extremities, head, ears, eyes, nose, throat and thyroid.|||Participants|||Number
1408245|NCT01193608|Primary|Number of Participants With Vital Signs of Potential Clinical Concern|Criteria for potential clinical concern in vital signs included: supine/sitting pulse rate of less than (<) 40 or more than (>) 120 beats per minute (bpm), and standing pulse rate of <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture and <90 mm Hg; diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture and <50 mm Hg. Only supine vital signs were planned for this study. Unplanned sitting vital signs were collected only in the 8/mg and placebo groups and also reported.|Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions).|||Participants|||Number
1408246|NCT01193608|Primary|Number of Participants With Laboratory Abnormalities||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).|||Participants|||Number
1408247|NCT01193608|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)||Baseline up to 39 Weeks and at Early Withdrawal|Safety analysis set consisted of all participants who received at least one infusion of study medication (including partial infusions). A TEAE was defined as an untoward medical occurrence reported by the participant or investigator following administration of at least one dose of AAB-003.|||Participants|||Number
1408248|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
1408249|NCT01193582|Secondary|Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.|Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|12 months after the last dose|Evaluable immunogenicity population consisted subjects who had received all , assigned vaccination(s), had blood drawn within required time frame for 12 month follow-up blood draw visit, had at least 1 valid and determinate assay result, had received no prohibited vaccines, and had no major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1408250|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
1408251|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3|Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after first dose of Prevenar in Group 3|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1408252|NCT01193582|Secondary|GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
1408253|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2|Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after second dose of Prevenar in Group 2|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1408254|NCT01193582|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.|GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||Fold rise||95% Confidence Interval|Geometric Mean
1408255|NCT01193582|Secondary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1|Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|1 month after third dose of Prevenar in Group 1|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1408256|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group|Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.|Baseline|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1408257|NCT01193582|Primary|Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar|Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|1 month after last dose in each group|Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.|||μg/mL||95% Confidence Interval|Geometric Mean
1408258|NCT01193556|Secondary|Operative Time, Estimated Blood Loss (EBL), Diet Volume and Activity Level||1-2 weeks post-operatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1408259|NCT01193556|Primary|Post-operative Pain|The primary outcome measure will be pain in each treatment group, as measured by visual analog scale twice daily in the 10 day period directly following surgery.|10 days immediately following surgery|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1408260|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort ≥40kg) N=5||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.|||micrograms/mL||Standard Deviation|Mean
1408261|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 30 - <40kg) N=1||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data. N=0 in the maintenance phase because the patient changed to ≥40kg body weight category|||micrograms/mL||Standard Deviation|Mean
1408262|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 20 - <30kg)||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort. Maintenance Phase was started either 2 weeks or 3 weeks after induction phase depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mL||Standard Deviation|Mean
1408263|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 10 - <20kg) N=7||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mL||Standard Deviation|Mean
1409032|NCT01189227|Secondary|The Difference in R0 and Combined R0 + R1 Resection Rates Between the Two Arms.||Assessed at the time of surgery|||||||
1408264|NCT01193348|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration (Body Weight Cohort 5 - <10kg) N=3||Induction Phase was between 1 and 4 weeks in length depending on patient weight cohort.Maintenance Phase was started 1 week after induction phase and dosing of eculizumab administration was every 2 weeks or every 3 weeks depending on patient weight cohort|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mL||Standard Deviation|Mean
1408265|NCT01193348|Secondary|Platelet Count Change From Baseline to 52 Weeks||Through 52 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1408266|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with eGFR Improvement through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408267|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through end of study was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Platelet Count Normalization through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408268|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through end of study was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete Hematologic Response through end of study were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408269|NCT01193348|Secondary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through End of Study, Median Exposure 55 Weeks|The tabulations of the proportions of patients with Complete TMA Response through end of study were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
1408270|NCT01193348|Secondary|Platelet Count Change From Baseline to 26 Weeks||Through 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measures ANOVA model. The estimated LS means of change from baseline at each post-baseline visit alongside with 95% CIs and P-values were calculated, as were the parameter estimates for the covariates and their associated P-values.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1408271|NCT01193348|Secondary|Proportion of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement|Proportion of Patients with Estimated Glomerular Filtration Rate (eGFR) Improvement was determined and defined as an increase in eGFR by ≥ 15 mL/min/1.73m2 from baseline, sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Estimated Glomerular Filtration Rate (eGFR) Improvement through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408272|NCT01193348|Secondary|Proportion of Patients With Platelet Count Normalization|Proportion of Patients with Platelet Count Normalization through 26 weeks of treatment was determined and defined as the platelet count observed to be ≥ 150 x 109/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The tabulations of the proportions of patients with Platelet Count Normalization through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408273|NCT01193348|Secondary|Proportion of Patients With Complete Hematologic Response|Proportion of Patients with Complete Hematologic response through 26 weeks of treatment was determined and defined by normalization of platelet count and LDH sustained for at least two consecutive measurements obtained at least four weeks apart.|Through 26 weeks|The tabulations of the proportions of patients with Complete Hematologic Response through 26 weeks were performed for the ITT population. The number of patients with response and responder rate, along with an exact two-sided 95% CI were summarized.|||Percentage of Participants||95% Confidence Interval|Number
1408274|NCT01193348|Primary|Proportion of Patients With Complete TMA Response|Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and ≥ 25% improvement in serum creatinine from baseline which was sustained for at least two consecutive measurements obtained at least four weeks apart).|Through 26 weeks|The tabulations of the proportions of patients with Complete TMA Response through 26 weeks were performed for the ITT population. Exact binomial two-sided 95% CI using the Clopper-Pearson method for the responder rate was presented.|||Percentage of Participants||95% Confidence Interval|Number
1408323|NCT01193244|Secondary|Percentage of Participants With Skeletal Related Events (SRE)|Skeletal related (SRE) event is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.|Baseline up to EOT (approximately up to 4.7 years)|The ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
1408275|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1408276|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1408277|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1408278|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
1408279|NCT01193335|Secondary|Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|Percentage of participants achieving OPA titer >=LLOQ for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) determined in blood samples of all participants was presented. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA antibody titer to the given serotype for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
1408280|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||titer||95% Confidence Interval|Geometric Mean
1408281|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.|||titer||95% Confidence Interval|Geometric Mean
1408282|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
1409033|NCT01189227|Secondary|Overall Survival||From study entry until the time of death or for a maximum of 5 years.|||||||
1408283|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|Before the toddler dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
1408284|NCT01193335|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series|Antibody-mediated serum OPA against the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 Month After Infant Series|Evaluable Infant Immunogenicity Population. Here n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
1408285|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408286|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408287|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408288|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408289|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable Infant Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408324|NCT01193244|Secondary|Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation||Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1408325|NCT01193244|Secondary|Worst Change From Baseline Over Time in Cardiac Ejection Fraction|Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point.|Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.|||percent ejection fraction||Standard Deviation|Mean
1408290|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|2 Years After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408291|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose|The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 Year After Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure during specified follow-up period and 'n' signifies participants with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408292|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Toddler Dose|Evaluable Toddler Immunogenicity Population.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408293|NCT01193335|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose|Geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before Toddler Dose (pre-vaccination)|Evaluable Toddler Immunogenicity Population. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408294|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1408295|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|1 month after the toddler dose|Evaluable Toddler Immunogenicity Population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2, 3 and toddler dose), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1408296|NCT01193335|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 % CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 Month After Infant Series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1408326|NCT01193244|Secondary|Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings||Baseline up to EOT (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1409034|NCT01189227|Secondary|RFS of Patients Event-free||From study entry until the date of recurrence or for a maximum of 6 months.|||||||
1408297|NCT01193335|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose|GMFR for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all participants with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws.|Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose|Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies participants with a determinate IgG antibody concentration to the given serotype for each arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
1408298|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1-year follow-up after toddler dose to 2-year follow-up after toddler dose|Safety population for 2-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.|||percentage of participants|||Number
1408299|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 month after toddler dose up to 1-year follow-up|Safety population for 1-year follow-up after toddler dose included all participants who received 13vPnC toddler dose and had safety data available during specified follow-up period.|||percentage of participants|||Number
1408300|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Toddler dose up to 1 Month after toddler dose|Safety population for toddler dose included all participants who received 13vPnC toddler dose.|||percentage of participants|||Number
1408301|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|1 Month after Dose 3 of the infant series up to toddler dose|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.|||percentage of participants|||Number
1408302|NCT01193335|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Dose 1 up to 1 month after Dose 3 (infant series)|Safety population for infant series included all participants who received at least 1 dose of 13vPnC during infant series.|||percentage of participants|||Number
1408303|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
1408304|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
1408305|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
1408306|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series|Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received 13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any event and 'n'=participants reporting yes for at least 1 day or no for all days for specified event for each group, respectively.|||percentage of participants|||Number
1408307|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after the toddler dose|Safety population for Toddler Dose: all participants who received 13vPnC Toddler Dose. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1408308|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 3 of the infant series|Safety population for Dose 3 infant series: all participants who received 13vPnC Dose 3.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1408309|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 2 of the infant series|Safety population for Dose 2 infant series: all participants who received 13vPnC Dose 2.Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1408310|NCT01193335|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.|Within 7 days after Dose 1 of the infant series|Safety population for Dose 1 infant series: all participants who received13vPnC Dose 1. Here 'N' (number of participants analyzed)=participants reporting yes for at least 1 day or no for all days for any local reaction.'n'=participants reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.|||percentage of participants|||Number
1408311|NCT01193335|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after the infant series|Evaluable infant immunogenicity population. Here ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
1408312|NCT01193335|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Evaluable infant immunogenicity population included eligible participants who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1408313|NCT01193283|Primary|Blood Counts and Adverse Event Profile After 6 Months of Treatment.|The safety endpoint will be toxicity profile after 6 months of treatment. The efficacy endpoint is complete response rate at 6 months, with complete response defined as blood counts no longer meeting the standard criteria for severe pancytopenia in severe aplastic anemia.|6 months||||participants|||Number
1408314|NCT01193244|Secondary|Time to Deterioration in Global Health Status|Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties).|Baseline until EOT (approximately up to 4.7 years)|The ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408315|NCT01193244|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes.|Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)|The Response Evaluation Criteria in Solid Tumors (RECIST) evaluable population included all participants who had measurable disease by RECIST 1.1 at the baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1408316|NCT01193244|Secondary|Time to Subsequent Antineoplastic Therapy|Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier.|Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)|The ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408317|NCT01193244|Secondary|Time to Docetaxel Chemotherapy|Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events.|Baseline until start of docetaxel chemotherapy (up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408318|NCT01193244|Secondary|Time to PSA Progression|Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA.|Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408319|NCT01193244|Secondary|Percentage of Participants Achieving PSA90 Response at Any Time During the Study|The PSA90 is defined as a decline of PSA by 90 percent from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37|ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
1408320|NCT01193244|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12|The PSA90 is defined as a decline of PSA by 90 percent from baseline.|Week 12|ITT population included all participants who were randomized.|||percentage of participants|||Number
1408321|NCT01193244|Secondary|Percentage of Participants Achieving PSA50 Response at Any Time During the Study|The PSA50 is defined as a decline of PSA by 50 percent from baseline.|Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37|ITT population where baseline and post-baseline assessments were available. The ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
1408322|NCT01193244|Secondary|Time to SRE|Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence.|Baseline up to EOT (Cycle 61 Day 58)|The ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408616|NCT01191944|Secondary|Levodopa (L-Dopa) Dose Change During the Study|Although the number of patients who began the study with concomitant L-dopa supplementation and required a change in dosage was not analysed for this study, the change from baseline in L-dopa dose is presented.|18 weeks|FAS. Only patients with concomitant L-Dopa treatment at baseline.|||mg||Standard Deviation|Mean
1408327|NCT01193244|Secondary|Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status|ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50 percent of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50 percent of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period.|Baseline until EOT (approximately up to 4.7 years)|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1408328|NCT01193244|Secondary|Number of Participants With TEAEs Related to Weight||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1408329|NCT01193244|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1408330|NCT01193244|Secondary|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3|Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE.|Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1408331|NCT01193244|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)|Safety population included all participants who received at least 1 dose of any study drug.|||participants|||Number
1408332|NCT01193244|Secondary|Time to Pain Progression|Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >=4 with a >=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference.|Baseline until End of treatment (EOT) (approximately up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408333|NCT01193244|Secondary|Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12|A favorable CTC count was defined as less than <5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (>=) 5 counts/7.5 mL in whole blood.|Week 12|ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
1408334|NCT01193244|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12|The PSA50 is defined as a decline of at least 50 percent (%) from baseline.|Week 12|ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
1408335|NCT01193244|Primary|Overall Survival|Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier.|Baseline until death (up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408336|NCT01193244|Primary|Radiographic Progression-free Survival (rPFS)|rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment.|Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
1408337|NCT01193218|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|between first drug intake of study medication up to a period of 7 days (inclusive) after the last drug intake of study medication, up to 392 days|Treated patients|||participants|||Number
1408338|NCT01193218|Secondary|Change From Baseline in FPG|Change from baseline in FPG after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)|||mg/dL||Standard Error|Least Squares Mean
1408339|NCT01193218|Secondary|Occurrence of Treat to Target Efficacy Response|Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 12 weeks of treatment|baseline and 12 weeks|Full analysis set (FAS)|||percentage of participants||95% Confidence Interval|Number
1408340|NCT01193218|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment.|The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.|baseline and 12 weeks|Full analysis set (FAS)|||percentage of HbA1c||Standard Error|Least Squares Mean
1409035|NCT01189227|Primary|Recurrence-free Survival (RFS)|Time to recurrence or death|From study entry until the date of recurrence or death or for a maximum of 5 years.|||||||
1408341|NCT01193153|Secondary|Double-blind: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
1408342|NCT01193153|Secondary|Open-label: Change From Baseline in Clinical Global Impression - Severity Schizoaffective Scale (CGI-S-SCA) Overall Score at Endpoint|"The CGI-S-SCA is a syndrome-specific 7-point scale (from 1 indicating not ill to 7 indicating very severely ill) that includes an overall severity score as well as scores for the positive, negative, manic, and depressive domains of the illness. The CGI-S-SCA was used to assess the level of overall impairment, as well as that related to each domain, at the time of the visit and for the week prior to the visit."|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
1408343|NCT01193153|Secondary|Double-blind: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
1408344|NCT01193153|Secondary|Open-label: Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Endpoint|The YMRS was designed to measure the severity of manic symptoms, to gauge the effect of treatment on mania severity, and to detect a return of manic symptoms (for example relapse or recurrence). YMRS is a checklist of 11 items that are ranked on a scale of 0 to 4 or 0 to 8. Seven of the items (elevated mood, increased motor activity, sexual interest, sleep, language-thought disorder, appearance, and insight) are ranked 0 to 4 and have descriptors associated with each severity level (that is, 0, 1, 2, 3, 4). Four of the items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 to 8 and have descriptors for every other increment (that is, 0, 2, 4, 6, 8). The item score is based on participant's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. Responses are summed to yield YMRS total score ranging from 0 to 60.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
1408345|NCT01193153|Secondary|Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
1408346|NCT01193153|Secondary|Open-label: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint|The HAM-D-21 is a 21-item, clinician-rated scale to evaluate depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on a 5-point (0 to 4) scale. The 5-point scale items use a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A rating of 4 is usually reserved for extreme symptoms. The responses for all 21 items are summed to yield the HAM-D-21 total score that ranges from 0-63.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
1408389|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
1409158|NCT01188460|Primary|Sleep Diary- Time to Fall Asleep|"Measures:~Time to Fall Asleep in minutes, higher scores indicate worse outcomes"|Timepoint 2 (week 7 of study participation).||||minutes||Standard Deviation|Mean
1408347|NCT01193153|Secondary|Double-blind: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
1408348|NCT01193153|Secondary|Open-label: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Endpoint (Week 13/LOCF) in OL Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a scale||Standard Deviation|Mean
1408349|NCT01193153|Secondary|Double-blind: Number of Participants With Personal and Social Performance (PSP) Categorical Scores|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. Number of participants in each specific category; good functioning (PSP total score >70), variable functioning (PSP total score between 31 and 70), and poor functioning (PSP total score <=30) were assessed.|Baseline and Endpoint (Week 64/LOCF) in DB period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values.'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||participants|||Number
1408350|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 64/LOCF) in double-blind period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. LOCF method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a Scale||Standard Error|Least Squares Mean
1408351|NCT01193153|Secondary|Open-label: Change From Baseline in Personal and Social Performance (PSP) Total Score at Endpoint|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Endpoint (Week 13/LOCF) in Open-label (OL) Lead-in period, Endpoint (Week 25/LOCF) in open-label stabilization period|OL ITT analysis set which included all randomly assigned participants who received at least one injection of open-label study medication. Last Observation Carried Forward (LOCF) method was used to impute missing values. 'n' signifies participants who were evaluable at each specified time point.|||Units on a Scale||Standard Deviation|Mean
1408352|NCT01193153|Secondary|Double-blind: Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 64 (Total Mixed Model Repeated Measures [MMRM] Analysis of Covariance [ANCOVA])|The PSP scale was designed to assess the degree of dysfunction a participant exhibits during a month prior to any visit within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior, each rated on 6-point scale (1=absent to 6=very severe). Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning. A score lying between 71 and 100 indicated a good functioning; one between 31 and 70 indicated varying degrees of difficulty, and a score of <=30 indicated functioning so poor that participant required intensive supervision.|Baseline and Week 64 of double blind relapse prevention period|DB ITT analysis set which included all randomly assigned participants who received at least one injection of double-blind study medication. 'n' signifies participants who were evaluable at each specified time point for each arm, respectively.|||Units on a scale||Standard Error|Least Squares Mean
1408390|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
1408617|NCT01191944|Secondary|Levodopa (L-Dopa) Introduction During the Study|Number of patients without concomitant L-Dopa treatment at baseline which required L-Dopa supplementation during the study.|18 weeks|FAS. Only patients without concomitant L-Dopa treatment at baseline.|||Participants|||Number
1408353|NCT01193153|Primary|Double-blind: Percentage of Participants Who Experienced Relapse|Relapse was defined as first occurrence of any 1 of following:psychiatric hospitalization due to worsening symptoms; any intervention employed to avert imminent hospitalization due to worsening symptoms or need for additional antipsychotic,antidepressants/mood stabilizing medication; deliberate self-injury,suicidal/homicidal ideation that is clinically significant as determined by investigator,or violent behavior resulting in clinically significant injury to another person or property damage; worsening of any 1 or more of 8 selected positive and negative syndrome scale(PANSS) items to a score of greater than or equal to (>= 6) after randomization(if the score for the corresponding item was less than or equal to [<=] 4 at randomization); worsening of certain other measures in specific ways at 2 consecutive visits. Relapse by subgroup of participants on monotherapy,adjunctive therapy to antidepressants/mood stabilizers,participants with psychotic symptoms/mood symptoms was examined.|Day 1 up to Month 15 of double blind relapse prevention period|Double-blind(DB) Intent-to-Treat(ITT) analysis set included all randomly assigned participants who received at least 1 injection of DB study medication.‘n’ signifies participants who were evaluable for each specified category,for each arm.|||percentage of participants|||Number
1408354|NCT01193127|Secondary|Use of Pain Medications After Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects|||participants|||Number
1408355|NCT01193127|Secondary|Use of Pain Medications at Day 1|Ocular pain medications were identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 were presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|All randomized subjects|||participants|||Number
1408356|NCT01193127|Secondary|Postoperative Use of Ophthalmic Anti-inflammatory Medications|Ophthalmic anti-inflammatory medications were identified by reviewing concomitant medications. Subject incidence of ophthalmic anti-inflammatory medication use by post-surgery day was presented. Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|All randomized subjects|||participants|||Number
1408357|NCT01193127|Secondary|Ocular Pain VAS Score After Day 0|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery were summarized.|43 days|Subjects with data at time point.|||mm||Standard Deviation|Mean
1408358|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 30|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|30 days|Subjects with data at time point.|||cells||Standard Deviation|Mean
1408359|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 14|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|14 days|Subjects with data at time point.|||cells||Standard Deviation|Mean
1408360|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 7|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Seven days|Subjects with data at time point.|||cells||Standard Deviation|Mean
1408361|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 2|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two days|Subjects with data at time point.|||cells||Standard Deviation|Mean
1408362|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Day 1|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|One day|Subjects with data at time point.|||cells||Standard Deviation|Mean
1408363|NCT01193127|Secondary|Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery|The mean anterior chamber cell count was calculated as the average of the two anterior chamber cell counts. If a cell count was indicated as > 30, it was imputed as 45 for the purpose of treatment comparisons which was performed using pairwise Wilcoxon tests.|Two hours|Subjects with data at time point.|||cells||Standard Deviation|Mean
1408364|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.|||participants|||Number
1408391|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
1409159|NCT01188460|Primary|Sleep Diary- Total Sleep Time|"Measures:~Total Sleep Time in hours, higher scores indicate better outcomes"|Timepoint 2 (week 7 of study participation).||||hours||Standard Deviation|Mean
1408365|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.|||participants|||Number
1408366|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.|||participants|||Number
1408367|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.|||participants|||Number
1408368|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.|||participants|||Number
1408369|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.|||participants|||Number
1408370|NCT01193127|Secondary|Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline|"Number of subjects with Summed Ocular Inflammation Score (SOIS) = 0, summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.|||participants|||Number
1408392|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
1408487|NCT01192542|Secondary|Bulbar Redness of Grade 3 or Above|Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.|||Subject Eyes|Eyes||Number
1408371|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|30 days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1408372|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|14 days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1408373|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Seven days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1408374|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two days|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1408375|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1408376|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery|"TPostoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Two hours|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1408393|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Seven Days Post-Surgery 7 Days|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
1408377|NCT01193127|Secondary|Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject’s anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|Baseline|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
1408378|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 30|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|30 days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
1408379|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 14|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|14 days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
1408380|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 7|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Seven days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
1408381|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 2|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Two days|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
1408382|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Day 1|Best-Corrected Visual Acuity (BCVA) was summarized by the ETDRS visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|One day|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
1408383|NCT01193127|Secondary|Best Corrected Visual Acuity (BVCA) - Log Score, Baseline|Best-Corrected Visual Acuity (BCVA) was summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis. Treatment comparisons for BCVA were performed by pairwise Wilcoxon tests.|Baseline|Subjects with scores at time point.|||Log score||Standard Deviation|Mean
1408384|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
1408385|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
1408386|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
1408387|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
1408388|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Haziness One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
1408394|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
1408395|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
1408396|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
1408397|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Foreign Body Sensation Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
1408398|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
1408399|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
1408400|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
1408401|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
1408402|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
1408403|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching 6 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
1408404|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Itching Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
1408405|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 30 Days Post-Surgery/Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
1408406|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
1423324|NCT01070784|Primary|ECG Variables - RR Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
1408407|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
1408408|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
1408409|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
1408410|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
1408411|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Eye Discharge 2 Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
1408412|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia 30 Days Post-Surgery /Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Up to 30 days|Subjects with scores at time point.|||participants|||Number
1408413|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
1408414|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
1408415|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
1408416|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
1408417|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
1408418|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Photophobia Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
1408419|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, 30 Days Post-Surgery/ Early Termination|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|up to 30 days|Subjects with scores at time point.|||participants|||Number
1423325|NCT01070784|Primary|ECG Variables - QTcF Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
1408420|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, 14 Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|14 days|Subjects with scores at time point.|||participants|||Number
1408421|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Seven Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Seven days|Subjects with scores at time point.|||participants|||Number
1408422|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Two Days Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two days|Subjects with scores at time point.|||participants|||Number
1408423|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, One Day Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|One day|Subjects with scores at time point.|||participants|||Number
1408424|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Six Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Six hours|Subjects with scores at time point.|||participants|||Number
1408425|NCT01193127|Secondary|Ocular Symptoms Using Numerical Rating System – Tearing, Two Hours Post-Surgery|The ocular symptom outcomes were based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System – NRS) at each time point for each assessment (tearing, photophobia, eye discharge, itching, foreign body sensation, and haziness). Treatment comparisons were performed using a Cochran-Mantel- Haenszel (CMH) test adjusting for the stratification factor LOCS II grade.|Two hours|Subjects with scores at time point.|||participants|||Number
1408426|NCT01193127|Primary|Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively|For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.|through 12 hours post-surgery|Subjects with postoperative VAS scores.|||units on a scale||Standard Deviation|Mean
1408427|NCT01193127|Primary|Pupil Diameter (mm) During Surgery|Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.|During surgery (immediately prior to surgical incision to wound closure)|Subjects with interpretable video recordings obtained during surgery.|||mm||Standard Deviation|Mean
1408428|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||units on a scale||Standard Deviation|Mean
1408429|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||units on a scale||Standard Deviation|Mean
1408430|NCT01193114|Secondary|BDI Depression Score|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||units on a scale||Standard Deviation|Mean
1408431|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||9 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||percent days of substance use||Standard Deviation|Mean
1408432|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||6 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||percent days of substance use||Standard Deviation|Mean
1408433|NCT01193114|Primary|Percent Days of Substance Use in the Prior 3 Months.||3 months post-baseline measure|The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.|||percent days of substance use||Standard Deviation|Mean
1408434|NCT01193101|Secondary|Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8|From week 8 to week 9, participants entered a single-blind placebo withdrawal period to assess the effect of LCZ696 on blood pressure following its discontinuation. Participants, who were randomized to the LCZ696 treatment groups, were discontinued from CLCZ696 at the end of week 8 and all 4 treatment groups received single-blind placebo for 1 week post week 8. A positive change from week 8 to week 9 indicates worsening.|8 weeks, 9 weeks|Only participants from the full analysis, who had values at both week 8 and week 9, were included in the analysis. The FAS included all randomized participants.|||mmHg||Standard Deviation|Mean
1408435|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS) The FAS included all randomized participants.|||ratio|||Number
1408436|NCT01193101|Secondary|Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP|Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]|baseline, 8 weeks|Full Analysis Set (FAS): The FAS included all randomized participants.|||ratio|||Number
1408437|NCT01193101|Secondary|Number of Participants Who Achieved Successful BP Control|BP control is defined as BP < 140/90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.|||Participants|||Number
1408438|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msSBP|Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.|||Participants|||Number
1408439|NCT01193101|Secondary|Number of Participants Who Achieved a Successful Response in msDBP|Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.|8 weeks|Participants from the full analysis set (FAS), who had week 8 values, were analyzed. The FAS included all randomized participants.|||Participants|||Number
1408440|NCT01193101|Secondary|Change From Baseline in Mean Ambulatory Pulse Pressure|Mean ambulatory pulse pressure is the difference in maSBP and maDBP (maSBP - maDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
1408441|NCT01193101|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Mean sitting pulse pressure is the difference in msSBP and msDBP (msSBP - msDBP). A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
1408442|NCT01193101|Secondary|Change From Baseline in Nighttime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
1408443|NCT01193101|Secondary|Change From Baseline in Daytime Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
1408444|NCT01193101|Secondary|Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP|Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
1408445|NCT01193101|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
1408446|NCT01193101|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.|Baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were analyzed. The FAS included all randomized participants.|||mmHg||Standard Error|Least Squares Mean
1408447|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Nasal and Bronchial Eicosanoids and Leukotrienes at 7 Hours Post-allergen Challenge.|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then prostaglandin and leukotriene concentrations were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As this same approach in a parallel study was unfruitful, these data were not pursued, and results are not presented.||||||
1408486|NCT01192542|Primary|Binocular Visual Acuity|Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results|Post lens insertion (baseline)|Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol.|||LogMAR||Standard Error|Least Squares Mean
1408448|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Cytokines From Bronchoalveolar Lavage Fluid (BALf)|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 23 hours had elapsed, BALf were collected, then the concentrations of IL-5, IL-13, and TARC were determined from BALf collected after 23 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 23 hours post-allergen challenge|As concentrations of cytokines were below the lower limit of quantitation this analysis was not performed, and results are not presented.||||||
1408449|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-23 (IL-23) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-23 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was plan to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As IL-23 levels were too low to detect, this analysis was not performed and results are not presented.||||||
1408450|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymic Stromal Lymphopoietin (TSLP) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TSLP were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was planned to be determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|As TSLP levels were too low to detect, this analysis was not performed and results are not presented.||||||
1408451|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Macrophage Inflammatory Protein-1β (MIP-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of MIP-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1408452|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-1β (IL-1β) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-1β were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1408453|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Interleukin-17 (IL-17) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-17 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1408454|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in RNA Expression for Genes Encoding IL-5 and IL-13 From Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, SP were collected, then the RNA expression profiles of IL-5 and IL-13 genes were determined from SP collected after 7 hours and previously at baseline, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1408455|NCT01193049|Secondary|Change in Vibration Response Imaging (VRI) After Metacholine Exposure|One hour before treatment with prednisone/placebo, participants inhaled for 2 minutes a nebulised solution of metacholine (0.13 ml/min); then one hour after prednisone/placebo treatment were challenged with allergens. From 1 to 7 hours after allergen challenge, ventilatory heterogeneity was assessed by Vibration Response Imaging (VRI) by monitoring the following: inspiration/expiration (I/E) amplitude ratio, I/E duration ratio, synchrony duration, and quantitative lung data.|From 1 to 7 hours post-allergen challenge|As all VRI results showed no allergen or treatment-related signals these results are not presented.||||||
1408456|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Eotaxin-3 From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of Eotaxin-3 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1408457|NCT01193049|Secondary|Geometric Mean Fold Change From Baseline in Thymus and Activation Regulated Chemokine (TARC) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of TARC were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1410446|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1408458|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-13 (IL-13) From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, NE and SP were collected, then the concentrations of IL-13 were determined from NE and SP collected after 7 hours and previously at BL, to derive the FC from BL for each participant. The GM was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1408459|NCT01193049|Primary|Geometric Mean Fold Change From Baseline in Interleukin-5 (IL-5) Concentration From Nasal Exudates and Sputum at 7 Hours Post-allergen Challenge|Participants were treated with either prednisone or placebo, followed 1 hour later by nasal allergen challenge and then inhaled allergen challenge. After 7 hours had elapsed, nasal exudates (NE) and sputum (SP) were collected, then the concentrations of IL-5 were determined from NE and SP collected after 7 hours and previously at baseline (BL), to derive the fold change (FC) from BL for each participant. The geometric mean (GM) was determined by averaging FC from BL for all analyzed participants.|Baseline and 7 hours post-allergen challenge|All randomized participants|||Fold Change||90% Confidence Interval|Geometric Mean
1408460|NCT01192828|Other Pre-specified|Difference in Diastolic Blood Pressure in Individuals With CBSDH Receiving Both Low Dose and Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment).||Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who were treated with taurine, this being both low dose and targeted dose of medication.|||mmHg||Standard Deviation|Mean
1408461|NCT01192828|Other Pre-specified|Difference in Systolic Blood Pressure in Individuals With CBSDH Receiving Both Low Dose and Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment).||Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who were treated with taurine, this being both low dose and targeted dose of medication.|||mmHg||Standard Deviation|Mean
1408462|NCT01192828|Other Pre-specified|Difference in Triglycerides in Individuals With CBSDH Receiving Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment)|Triglycerides were measured in a CLIA approved clinical laboratory. Triglycerides are a natural occurring fat, High levels over a long period of time can increase the chances for heart disease. Levels greater that 1000 mg/dl over a short period of time can increase chances of pancreatitis.|Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mg/dL||Standard Error|Mean
1408463|NCT01192828|Other Pre-specified|Difference in Triglycerides in Individuals With CBSDH Receiving Both Low Dose and Target Dose Taurine Pre and Post Taurine Treatment (Safety Assessment)|Triglycerides were measured in a CLIA approved clinical laboratory.Triglycerides are a natural occurring fat. High levels over a long period of time can increase the chances for heart disease. Levels greater that 1000 mg/dl over a short period of time can increase chances of pancreatitis.|Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who were treated with taurine, this being both low dose and targeted dose of medication.|||mg/dL||Standard Error|Mean
1408464|NCT01192828|Other Pre-specified|Determination of Baseline Taurine Level, Peak Taurine Level on Day One, Trough Level on Day One and Trough Level on Day Four of Taurine Treatment.|Taurine was measured in plasma via liquid chromatogram(LC)-MS/MS.|Taurine levels were obtained prior to taurine adminstration and at , t=0.5, t=1, t=2, t=3, t=4, t=6, t=8, t=12 and 96 hours.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||microM||Standard Deviation|Mean
1408465|NCT01192828|Other Pre-specified|Thiobarbituric Acid Reactive Substances (TBARS) in Individuals With CBSDH Compare to Homocysteine Level.|TBARS were measured in plasma via colorimetric absorbance. Homocysteine was measured in serum by gas chromatography/mass spectrometry (GC/MS) in a Clinical Laboratory Improvements Amendments (CLIA) approved clinical laboratory. TBARS are a marker of oxidative stress. TBARS are formed as a by-product of lipid (fat) oxidation. TBARS predominantly reflect the level of malondialdehyde (MDA) a substance that is formed from the breakdown of polyunsaturated fatty acids.|Baseline|Analyzable data from all subjects with CBSDH who completed day one of active study and normal homocysteine values provided by assaying laboratory were used for the calculations.|||micromol/l||Standard Error|Mean
1408466|NCT01192828|Secondary|Percent of Individuals With Decreased Bone Mineral Density.|Bone mineral density was assessed via whole body dual energy X-ray absorptiometry (DEXA) with bone density corrected for age. The absolute DEXA value was not used for analysis, rather values below 2 standard deviations of normal were taken as evidence of osteoporosis.|Baseline|Analysis was on all analyzable data from subjects with CBSDH who participated in the active study and data from control population as provided by DEXA report.|||Participants|||Count of Participants
1408467|NCT01192828|Secondary|Difference in Endothelial Function (Blood Vessel Function) in Individuals With CBSDH and Pre Taurine Exposure FMD Values Less Than 10 mm Pre and Post Taurine Treatment.|Endothelial function was measured by doppler brachial artery flow-mediated dilation (FMD) studies.|Baseline and after 4.5 days of therapy.|Analyzable data from all individuals with CBSDH studied with baseline flow mediated dilation values of less than 10 mm and who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mm||Standard Error|Mean
1408468|NCT01192828|Secondary|Difference in Endothelial Function (Blood Vessel Function) in Individuals With CBSDH and Homocysteine Levels Greater Than 125 Micromole/L Pre and Post Taurine Treatment.|Endothelial function was measured by doppler brachial artery flow-mediated dilation (FMD) studies.|Baseline and after 4.5 days of therapy.|Analyzable data from all individuals with CBSDH having baseline homocysteine levels greater than 125 micromole/L who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mm||Standard Error|Mean
1408469|NCT01192828|Secondary|Difference in Endothelial Function (Blood Vessel Function) in Individuals With CBSDH Pre and Post Taurine Treatment|Endothelial function was measured by doppler brachial artery flow-mediated dilation (FMD) studies.|Baseline and after 4.5 days of taurine treatment|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||mm||Standard Error|Mean
1408470|NCT01192828|Primary|Difference in Tumor Necrosis Factor Alpha (TNF-alpha) in Individuals With CBSDH Pre and Post Taurine Treatment.|TNF-alpha was measured in plasma via Luminex high sensitivity assay. TNF-alpha is a signaling protein, or cytokine that promotes an inflammatory response.|Baseline and after 4 days of treatment.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from the analysis.|||pg/ml||Standard Error|Mean
1408471|NCT01192828|Primary|Difference in Thiobarbituric Acid Reactive Substances (TBARS) in Individuals With Cystathionine Beta Synthase Deficient Homocystinuria (CBSDH) Pre and Post Taurine Treatment.|TBARS were measured in plasma via colorimetric absorbance. TBARS are a marker of oxidative stress. They are formed as a by-product of lipid (fat) oxidation. TBARS predominantly reflect the level of malondialdehyde (MDA) a substance that is formed from the breakdown of polyunsaturated fatty acids.|Baseline and after 4 days of therapy.|Analyzable data from all individuals with CBSDH who received the target dose of taurine were used for the calculations. The two individuals treated with low dose taurine were excluded from he analysis.|||nmol/ml||Standard Error|Mean
1408472|NCT01192776|Other Pre-specified|Severe Neonatal Brain Abnormalities|"The data for this analysis have not yet been collected.~MRIs taken between 7-14 days will be examined."|7-14 days of life||2020-07-31|07/2020||||
1408473|NCT01192776|Secondary|Multiorgan Dysfunction|The data needed for this analysis are not collected directly, and needs to be coded based on the available information. This is a complex undertaking and will take additional time to create. Once created, we will promptly report the results and anticipate reporting by March 2018.|Until death, discharge, or transfer||2018-07-31|07/2018||||
1408474|NCT01192776|Secondary|Multiple Disabilities|Multiple disabilities is defined as two or more of the following 5 components: disabling CP, GMFCS level 3-5, Bayley cognitive score < 70, blindness, or deafness.|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
1408475|NCT01192776|Secondary|Hearing Impairment|Hearing impairment is defined as hearing impairment despite amplification|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
1408476|NCT01192776|Secondary|Visual Impairment|Visual impairment is defined as bilateral blindness with some/no useful vision|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
1408477|NCT01192776|Secondary|Level of Disability Among Survivors, by Level of HIE|Among survivors, number of normal infants and infants with mild, moderate and severe disability Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge.|Follow up at 18-22 months corrected age|Includes all infants followed at 18-22 months, except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths.|||Participants|||Count of Participants
1408478|NCT01192776|Secondary|Cerebral Palsy||Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||Participants|||Count of Participants
1408479|NCT01192776|Secondary|Bayley Cognitive Score|Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.|Follow up at 18-22 months corrected age|Infants who survived and were followed at 18-22 months|||scores on a scale||Inter-Quartile Range|Median
1408480|NCT01192776|Secondary|Clinical Neonatal Seizures|Documented seizures during hospital course|Through death, discharge, or transfer||||Participants|||Count of Participants
1408481|NCT01192776|Secondary|Withdrawal of Care|Number of infants for whom aggressive care is withdrawn|Birth through hospital discharge, average 22 days.||||Participants|||Count of Participants
1408482|NCT01192776|Secondary|Level of Disability Among Survivors|"Among survivors number of normal infants and infants with mild, moderate, and severe disability~Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score ≥ 85 in the absence of any neurosensory deficits or seizures after NICU discharge."|Follow up at 18-22 months corrected age|Includes all infants followed at 18-22 months except for 6 infants who could not be distinguished between normal and mild. Does not include 17 infants lost to follow up or 56 deaths|||Participants|||Count of Participants
1408483|NCT01192776|Secondary|Death|Death includes any mortality prior to follow up at 18-22 months.|Birth to 22 months corrected age|Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.|||Participants|||Count of Participants
1408484|NCT01192776|Primary|Death or Moderate to Severe Disability|Death includes any mortality prior to follow up at 18-22 months. Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands.|Birth to 22 months corrected age|Includes all deaths and all infants followed at 18-22 months. Does not include 17 infants lost to follow up.|||Participants|||Count of Participants
1408485|NCT01192698|Primary|HCV RNA Result|Will measure mean HCV RNA levels 4 weeks after liver transplant|4 weeks after liver transplant||||IU/ml||Standard Deviation|Mean
1410298|NCT01178944|Other Pre-specified|Overall Survival (OS) for SNP ATIC/AICART - s10932606 Genotypes|Kaplan-Meier estimates of median survival time for each genotype|From the date of study enrollment up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1408488|NCT01192542|Secondary|Limbal Redness of Grade 3 or Above|Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.|After 6-8 days of lens wear|Analysis was conducted on subjects who successfully completed the study.|||Subject Eyes|Eyes||Number
1408489|NCT01192542|Primary|Monocular Visual Acuity Assessment|Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.|Post lens insertion (baseline)|Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study.|||logMAR|eyes|Standard Error|Least Squares Mean
1408490|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance people walk in feet over 6 minutes|6 months post baseline|Numbers may differ due to missing data|||feet||Standard Deviation|Mean
1408491|NCT01192516|Secondary|Physical Function- Six Minute Walk|This is the distance in feet that people walk over 6 minutes.|10 weeks post-baseline|Numbers may differ due to missing data|||feet||Standard Deviation|Mean
1408492|NCT01192516|Secondary|Physical Function- Six Minute Walk|Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes|Baseline|Numbers may vary due to missing data|||feet||Standard Deviation|Mean
1408493|NCT01192516|Primary|Pain- WOMAC|This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.|6 months post baseline|Numbers may vary due to missing data|||units on a scale||Standard Deviation|Mean
1408494|NCT01192516|Primary|Pain- WOMAC|This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.|10 weeks post-baseline|Sample numbers may differ due to missing data|||units on a scale||Standard Deviation|Mean
1408495|NCT01192516|Primary|Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.|Baseline||||units on a scale||Standard Deviation|Mean
1408496|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.|6 months post-baseline|Sample numbers may vary due to missing data|||units on a scale||Standard Deviation|Mean
1408497|NCT01192516|Primary|Fatigue-BFI|This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|10 weeks post-baseline|Sample numbers may differ due to missing data|||units on a scale||Standard Deviation|Mean
1408498|NCT01192516|Primary|Fatigue- Brief Fatigue Inventory (BFI)|This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.|Baseline||||units on a scale||Standard Deviation|Mean
1408499|NCT01192412|Secondary|Serious Maternal Complications Measured up to 6 Weeks Postpartum|"Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications:~Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or~End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion)"|6 weeks||||participants|||Number
1408500|NCT01192412|Primary|Pregnancy Loss or NICU Admission for Greater Than 48 Hours|Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records.|6 weeks||||participants|||Number
1408501|NCT01192399|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Score (Global Health Status)|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. For global health status, a high score represents a high quality of life.|Baseline, Week 12||||units on a scale||Standard Error|Least Squares Mean
1408502|NCT01192399|Secondary|Change From Baseline in Plasma Free Hemoglobin||Baseline, Week 12||||mg/dL||Standard Error|Mean
1408503|NCT01192399|Secondary|Change From Baseline in Lactate Dehydrogenase (LDH) Area Under the Curve (AUC)||Baseline to Week 12||||U/L x Day||Standard Error|Mean
1408504|NCT01192399|Secondary|Number of Units of Packed Red Blood Cells (pRBCs) Transfused|Comparison of number of units of pRBCs transfused in the 12 weeks prior to the first dose of eculizumab, and between baseline and 12 weeks after the first dose of eculizumab|12 weeks pre-treatment, baseline, 12 weeks post-treatment||||Units||Standard Error|Mean
1408505|NCT01192399|Secondary|Change From Baseline in Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Count||Baseline, Week 12||||cells x 10^12/L||Standard Error|Mean
1408506|NCT01192399|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Total Score|The FACIT-Fatigue scale, Version 4.0, is a collection of quality of life questionnaires pertaining to the management of fatigue symptoms due to a chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Patients score each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores range from 0 to 52, with higher score indicating better quality of life.|Baseline, Week 12||||units on a scale||Standard Error|Mean
1408507|NCT01192399|Primary|Change From Baseline in Lactate Dehydrogenase||Baseline, Week 12||||Units/Liter||Standard Error|Mean
1408508|NCT01192347|Secondary|Maximum Daily Dose of Anagrelide Hydrochloride||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||mg/day||Standard Deviation|Mean
1408509|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
1408510|NCT01192347|Secondary|Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
1408511|NCT01192347|Secondary|Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
1408512|NCT01192347|Secondary|Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
1408513|NCT01192347|Secondary|Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
1408514|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408515|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408533|NCT01192295|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population.|Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||participants|||Number
1408516|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408517|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408518|NCT01192347|Primary|Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Full response is a platelet count of <400x10^9/L. Partial response is a platelet count between 400-600x10^9/L or a platelet count reduction of 200x10^9.~Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408519|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408520|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when XAGRID treatment was initiated, using the following variables:~Initiation of XAGRID dosing consistent with the Summary of Product Characteristics (SmPC):~Consistent if:~The starting dose was <=1 mg/day, AND~Any increase in dose was no more than 0.5mg/day, AND~Any increase in dose was made at least 7 days after first initiation or at least 7 days after any previous modification (up or down), AND~The maximum dose did not exceed 10 mg/day at any stage.~Inconsistent: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408521|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408522|NCT01192347|Secondary|Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||participants|||Number
1408523|NCT01192347|Secondary|Percentage of Subjects With Anagrelide Hydrochloride Starting Doses||6 months|Safety Set comprised all subjects who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment documented.|||percentage of subjects|||Number
1408534|NCT01192282|Primary|Commonest HPV Genotypes Isolated by HIV Status|10 commonest types of HPV isolated according to HIV status|18 months||||Participants|||Number
1408524|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408525|NCT01192347|Primary|Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation|"Patients who had taken a previous cytoreductive therapy were divided into subgroups based on the treatment regimens used when Anagrelide Hydrochloride treatment was initiated, using the following variables:~•Withdrawal of previous cytoreductive therapy:~Before: if a stop date of previous cytoreductive therapy was prior to the date of Anagrelide Hydrochloride initiation~After: if a stop date of previous cytoreductive therapy was between the first administration and the last administration of Anagrelide Hydrochloride during the follow-up~Not Withdrawn: in all other cases"|6 months|Full Analysis Set (FAS) comprised all enrolled patients for whom Anagrelide Hydrochloride therapy was initiated. Subjects who had not taken any previous cytoreductive therapy other than Anagrelide Hydrochloride were excluded from the FAS.|||percentage of subjects||95% Confidence Interval|Number
1408526|NCT01192295|Secondary|Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets|Plasma concentration data were characterized for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients. Plasma samples were collected after the first dose on day 1 (one sample 2 to 4 hours after the dose and 1 sample 4 to 6 hours after the dose with approximately 2 hours between the samples), and immediately predose (morning or evening dose) and 2 to 4 hours after that dose at visit 2 and/or visit 3; a total of 4 to 6 samples were collected.|Day 1, week 2, and week 4|||||||
1408527|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
1408528|NCT01192295|Secondary|Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years|The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
1408529|NCT01192295|Secondary|Parent/ Caregiver-Assessed Global Impression of Change (PGIC)|The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group.|Baseline to week 4 or early discontinuation|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||participants|||Number
1408530|NCT01192295|Secondary|Use of Supplemental Pain Medication|Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||participants|||Number
1408531|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years|Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked “no pain” and the opposite end marked as “pain as bad as it could be.” The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the “no pain” end to the patient’s mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
1408532|NCT01192295|Secondary|Pain Right Now Assessment by Patients Aged 6 to < 12 Years|Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with “no hurt” at the far left and “hurts worst” at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment.|Baseline to week 4|The safety population was the group of patients who received at least 1 dose of study drug during the study.|||units on a scale||Standard Deviation|Mean
1408539|NCT01192204|Secondary|Changes in Lesional Sizes|The remaining oral dysplasia lesion will be inspected at each follow up appointment (every 10-14 days). Biopsies will be immediately conducted on patients with any indication of malignant transformation including indurated, rolled borders, nonhealing ulcers, etc. Accordingly, these patients will withdraw from the trial. Participants will also be monitored for any changes consistent with contact mucositis e.g. soreness and erythema at application site. Clinical photographs were taken for the patients records. Pre treatment and post treatment photographs, with a ruler in place, were used for accurate pre and post treatment size measurement. NOTE: if treatment is beneficial, lesional size will decrease which will be reflected as a negative number.|pretreatment and posttreatment (3 months treatment duration)||||mm^2||Standard Deviation|Mean
1408540|NCT01192204|Primary|Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment|A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl excisional biopsy of the treatment site including any remaining residual lesional tissue (excision of oral dysplastic lesions is consistent with current standards of care) will be obtained after 3 months of treatment to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME).|Before and after the 3 month treatment.|The population evaluated were as previously described i.e. 22 participants in the BRB gel cohort and 18 participants in the placebo gel cohort.|||unit on histologic grade scale||Standard Error|Mean
1408541|NCT01192191|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.|Baseline (Week -2), Week 12, Week 24, and Week 52|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1408542|NCT01192191|Secondary|Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Beats/Minute||Standard Deviation|Mean
1408543|NCT01192191|Secondary|Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD|ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1408544|NCT01192191|Secondary|Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)|24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)|The Urine Cortisol Population: all participants in the ITT Population for whom a urine sample was obtained and whose urine sample was not considered to have confounding factors that could affect the interpretation of the results. Only those participants with post-Baseline data available at the indicated time points were analyzed.|||Nanomoles (nmol)/24 hours||Geometric Coefficient of Variation|Geometric Mean
1408545|NCT01192191|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)|Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.|Baseline (Week -2), Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1408546|NCT01192191|Secondary|Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1408547|NCT01192191|Secondary|Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)|Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.|Baseline (Week -2), and Week 52/Withdrawal (WD)|"ITT Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.; thus the number of participants analyzed reflects everyone in the ITT Population. The number of participants assessed for each parameter is indicated by n=X, X."|||Participants|||Number
1408548|NCT01192191|Secondary|Number of Participants With Pneumonia During the Treatment Period|Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population|||Participants|||Number
1408549|NCT01192191|Primary|Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|ITT Population|||Participants|||Number
1408550|NCT01192191|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])|Intent-to-Treat (ITT) Population: all participants who had been randomized to and received at least one dose of randomized medication in the treatment period|||Participants|||Number
1408551|NCT01192178|Secondary|Mean Percentage of Rescue-free Days|A rescue-free day was defined as a day during the Peak Viral Period on which no puffs of rescue medication were recorded. Percentage of rescue-free days was defined as the number of days during the Peak Viral Period on which no puffs of rescue medication were recorded, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.|||Percentage of days||Standard Deviation|Mean
1408552|NCT01192178|Secondary|Mean Percentage of Symptom-free Days|A symptom-free day was defined as a day during the Peak Viral Period on which the asthma symptom score was zero. The daily asthma symptom score (measured during the day and the previous night) was reported on a 6-point scale (ranging from 0=no symptoms to 5=severe symptoms). Percentage of symptom-free days was defined as the number of days during the Peak Viral Period on which the asthma symptom score=0, divided by the number of days in that same period on which non-missing values were recorded, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period and had a treatment stop date with a defined Peak Viral Period were analyzed.|||Percentage of days||Standard Deviation|Mean
1408553|NCT01192178|Secondary|Mean Percentage of Episode-free (EF) Days|An EF day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, school absenteeism due to asthma, or morning peak expiratory flow (measure of maximum airflow) <80% of baseline. Percentage of EF days=No. of EF days divided by No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.|||Percentage of days||Standard Error|Mean
1408618|NCT01191944|Secondary|Change From Baseline in UPDRS III Score Separately at Week 18|UPDRS Part III (motor examination) ranges from 0 to 108. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)|||Units on a scale||Standard Error|Least Squares Mean
1408554|NCT01192178|Secondary|Mean Percentage of Asthma-control Days|An asthma-control day was defined as a day without any of the following: rescue albuterol use, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than double-blind study treatment, asthma symptom score >0, nighttime awakenings due to asthma, unscheduled health care visits (defined as home visits, office visits, or urgent care visits), ER visits, hospitalizations for asthma, or school absenteeism due to asthma. The percentage of asthma-control days = the number (No.) of asthma-control days divided by the No. of days of treatment exposure, multiplied by 100.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who recorded data during the Peak Viral Period, had a treatment stop date with a defined Peak Viral Period, and had available data on all days on which data were recorded were analyzed.|||Percentage of days||Standard Error|Mean
1408555|NCT01192178|Secondary|Number of Asthma Exacerbations Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection During the Peak Viral Period|Each participant (with assistance from the parent/legal guardian as needed) was instructed to keep an electronic diary (eDiary) with record of daily URTS symptoms that included: runny nose, sneezing, nasal congestion, and sore throat. Based on the best-described aggregate URTS during the previous 24 hours, participants rated symptoms as: 0 = Not present; 1 = Mild, clearly present; 2 = Moderately severe, uncomfortable; and 3 = Severe, interfering with sleep or activity. Mucus samples were collected and analyzed for RVwhen the eDiary alerted for moderate/severe URTS.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants who reported >=1 exacerbation were analyzed. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.|||Number of asthma exacerbations|||Number
1408556|NCT01192178|Secondary|Mean Duration of Worsening Asthma Symptoms Associated With the Presence of Moderate or Severe URTS or a Confirmed RV Infection|A worsening asthma day is one on which any of the following occurred: rescue albuterol use above baseline, use of oral/parenteral corticosteroids for asthma, use of asthma medication other than study medication, asthma symptom scores >=3, nighttime awakenings, unscheduled health care visits, or missed school due to asthma. The duration of worsening asthma is the number of consecutive worsening asthma days after the date of a URTS score of 2 (moderate) or 3 (severe) or collection of a mucus sample containing RV (whichever occurred first). Each span of consecutive days is a participant interval.|Peak Viral Period (from 30 August 2010 through the end of treatment [up to Week 16])|ITT Population. Only those participants with relevant data defining a worsening asthma day during the peak viral period and with moderate or severe URTS or a confirmed RV infection were analyzed.|||Days per participant interval||Standard Error|Mean
1408557|NCT01192178|Secondary|Mean Asthma Symptom Scores, as an Indicator of Severity, Associated With the Presence of Moderate or Severe Upper Respiratory Tract Symptoms (URTS) or a Confirmed Rhinovirus (RV) Infection at Baseline and During the Peak Viral Period|Participants recorded their asthma symptom score over the previous 24 hours (during the day and the previous night) using the following 6-point scale: 0=No symptoms; 1=Symptoms for 1 short period; 2=Symptoms for >=2 short periods; 3=Symptoms for most of the day/previous night that did not affect normal daily activities; 4=Symptoms for most of the day/previous night that affected normal daily activities; 5=Symptoms so severe that participant could not perform normal daily activities. The Baseline mean asthma symptom score was calculated as the average score over 7 days prior to Week 1, Visit 2.|Baseline (Week 1) and Peak Viral Period ([period during which the greatest number of viral infections is expected] from 30 August 2010 through the end of the treatment period [up to Week 16])|ITT Population. Only those participants with moderate or severe URTS or a confirmed RV infection were analyzed.|||Scores on a scale||Standard Deviation|Mean
1408558|NCT01192178|Primary|Total Number of Asthma Exacerbations Reported During the Treatment Period|An asthma exacerbation was defined as deterioration of asthma that required the use of outpatient oral/parenteral corticosteroids (tablets, suspensions, or injection) or an urgent care, hospitalization, or emergency room (ER) visit due to asthma that required oral/parenteral corticosteroids. Two exacerbations (out of a total of 51) were excluded: (1) one exacerbation occurred within 7 days of the resolution of an earlier one, and, per protocol, was combined with the previous exacerbation; and (2) one exacerbation occurred post treatment.|From Baseline (Week 1) until the end of treatment (up to Week 16)|Intent-to-Treat (ITT) Population: all participants randomized to treatment. Only those participants who reported >=1 exacerbation were analyzed.|||Number of asthma exacerbations|||Number
1408559|NCT01192152|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities considered clinically significant and/or reported as an AE by the investigator.|From Day 1 of Period 1 to Day 3 of Period 2 for participants in Treatment Sequence BA and Day 5 of Period 3 for participants in Treatment Sequence ABC|All subjects who received at least one dose of study medication.|||participants|||Number
1408560|NCT01192152|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on morning of Day 1/Period 1 through study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|All subjects who received at least one dose of study medication.|||participants|||Number
1408561|NCT01192152|Secondary|Metformin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||hour||Standard Deviation|Mean
1408562|NCT01192152|Secondary|Metformin AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C was administered only during Period 3, & this measure was analyzed for Periods 1 and 2.|||ratio||Standard Deviation|Mean
1408563|NCT01192152|Secondary|Metformin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408564|NCT01192152|Secondary|Metformin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||percentage of fluctuation||Standard Deviation|Mean
1408565|NCT01192152|Secondary|Metformin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408566|NCT01192152|Secondary|Metformin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408567|NCT01192152|Primary|Metformin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408568|NCT01192152|Secondary|Metformin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng*hr/mL||Standard Deviation|Mean
1408569|NCT01192152|Secondary|Metformin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408570|NCT01192152|Primary|Metformin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. 2 participants in Treatment A & 1 in Treatment B were excluded due to the inability to estimate with acceptable accuracy a terminal slope for terminal phase concentration data. Treatment C administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408571|NCT01192152|Secondary|5-hydroxy Saxagliptin Tmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||hour||Standard Deviation|Mean
1408572|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)/AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ratio||Standard Deviation|Mean
1408573|NCT01192152|Secondary|5-hydroxy Saxagliptin T1/2||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408574|NCT01192152|Secondary|5-hydroxy Saxagliptin Fluctuation %||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||percentage of fluctuation||Standard Deviation|Mean
1408575|NCT01192152|Secondary|5-hydroxy Saxagliptin Cavg||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408576|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmin||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408577|NCT01192152|Secondary|5-hydroxy Saxagliptin Cmax||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408578|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-tau)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng*hr/mL||Standard Deviation|Mean
1408579|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-t)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408580|NCT01192152|Secondary|5-hydroxy Saxagliptin AUC(0-inf)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408581|NCT01192152|Secondary|Saxagliptin Time to Achieve the Observed Maximum Plasma Concentration (Tmax)||Periods 1 & 2:predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36, 48 hours postdose. Period 3: predose on Days 2 & 3; predose, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hours postdose on Day 4.|All treated participants not discontinuing prior to end of study.|||hour||Standard Deviation|Mean
1408582|NCT01192152|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ratio||Standard Deviation|Mean
1408583|NCT01192152|Secondary|Saxagliptin Terminal Half-life (T1/2)||Periods 1 and 2: predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours postdosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408584|NCT01192152|Secondary|Saxagliptin Degree of Fluctuation Over the Dosing Interval (Fluctuation %)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||percentage of fluctuation||Standard Deviation|Mean
1408585|NCT01192152|Secondary|Saxagliptin Average Plasma Concentration Over the Dosing Period (Cavg)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408586|NCT01192152|Secondary|Saxagliptin Trough (Predose) Plasma Concentration (Cmin)||Period 3: predosing on Days 2 and 3; predosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours postdosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408587|NCT01192152|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1 & 2: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 & 48 hrs post-dosing. Period 3: predosing on Days 2 & 3; predosing, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24 hrs postdosing on Day 4|All treated participants not discontinuing prior to end of study.|||ng/mL||Standard Deviation|Mean
1408588|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the End of the Dosing Interval (AUC[0-tau])|Dosing interval = 24 hours.|Period 3: pre-dosing on Days 2 and 3; pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, and 24 hours post-dosing on Day 4.|All treated participants not discontinuing prior to end of study.|||ng*hr/mL||Standard Deviation|Mean
1408589|NCT01192152|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to end of study. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408590|NCT01192152|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])||Periods 1 and 2: pre-dosing, 15, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 18, 24, 36 and 48 hours post-dosing.|All treated participants not discontinuing prior to the end of study. One participant in Treatment A was excluded as a result of the inability to estimate with acceptable accuracy a terminal slope for the terminal phase concentration data. Treatment C was administered only during Period 3, and this outcome measure was analyzed for Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
1408591|NCT01192139|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and Electrocardiogram (ECG) Abnormalities|Abnormalities considered by the investigator to be clinically significant and/or reported as an AE.|From Day 1 of Period 1 through Day 3 of Period 3 (study discharge)|Safety Population|||Participants|||Number
1408592|NCT01192139|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from initiation of study drug administration on Day 1/Period 1 through study discharge Day 3/Period 3. SAEs: from date of written consent until 30 days after discontinuation of dosing or participation in study if last scheduled visit occurred later.|Safety Population = all participants who received any study drug.|||Participants|||Number
1408593|NCT01192139|Secondary|Metformin Fraction of AUC(0-inf) Contributed by AUC(0-t)(AUC[0-t]/AUC[0-inf])||Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC(0-inf) was due to the inability to estimate Kel for some of the subjects).|||ratio||Standard Deviation|Mean
1408594|NCT01192139|Secondary|Metformin Tmax||Periods 1, 2, and 3 (before dosing, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
1408595|NCT01192139|Secondary|Metformin T1/2|terminal half life; calculated as ln(2)/Kel|Period 1 (before dosing, 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|Treated participants (the smaller sample size for T1/2 was due to the inability to estimate Kel for some of the subjects).|||hours||Standard Deviation|Mean
1408596|NCT01192139|Primary|Metformin Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng/mL||Standard Deviation|Mean
1413502|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables||up to 47 days (visit 1 to visit 6)||||Participants|||Number
1408598|NCT01192139|Primary|Metformin AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|Treated participants (the smaller sample size for AUC[0-inf] was due to the inability to estimate potassium chloride for some participants)|||ng*hr/mL||Standard Deviation|Mean
1408599|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)/AUC(0-inf)||Period 1 (samples taken before dosing, and at 0.167,0.25,0.5,0.75,1,1.5,2,3,4,5,6,7,8,10,12,18,24,36 and 48 hours after dosing)|All treated participants|||ratio||Standard Deviation|Mean
1408600|NCT01192139|Secondary|Active Metabolite BMS-510849 Tmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
1408601|NCT01192139|Secondary|Active Metabolite BMS-510849 T1/2|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
1408602|NCT01192139|Secondary|Active Metabolite BMS-510849 Cmax||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng/mL||Standard Deviation|Mean
1408603|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-t)|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
1408604|NCT01192139|Secondary|Active Metabolite BMS-510849 AUC(0-inf)|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
1408605|NCT01192139|Secondary|Saxagliptin Fraction of AUC(0-inf) Contributed by AUC(0-t) (AUC[0-t]/AUC[0-inf])||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ratio||Standard Deviation|Mean
1408606|NCT01192139|Secondary|Time to Achieve the Observed Maximum Saxagliptin Plasma Concentration (Tmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
1408607|NCT01192139|Primary|Saxagliptin Observed Maximum Plasma Concentration (Cmax)||Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng/mL||Standard Deviation|Mean
1408608|NCT01192139|Secondary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (Ct), calculated using the linear trapezoidal rule.|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
1408609|NCT01192139|Secondary|Saxagliptin Terminal Half-life (T1/2)|terminal half life; calculated as ln(2)/Kel|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||hours||Standard Deviation|Mean
1408610|NCT01192139|Primary|Saxagliptin Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|Area under the plasma concentration versus time curve from time 0 extrapolated to infinity; calculated as AUC0-t [calculated using the linear trapezoidal rule] + Ct/Kel, where Ct was the last measurable concentration and Kel was the terminal rate constant|Periods 1, 2, and 3 (samples taken before dosing, and at 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36 and 48 hours after dosing)|All treated participants|||ng*hr/mL||Standard Deviation|Mean
1408611|NCT01192126|Primary|Slit Lamp Examination > Grade 2|Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp > 2.|All study visits from screening through 2 week follow-up|All Dispensed Eyes|||Eyes|Participants||Number
1408612|NCT01192126|Primary|Visual Acuity|Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.|Dispensing Visit and 1 week follow-up|All Eligible Dispensed Eyes|||LogMAR|Participants|Standard Deviation|Mean
1408613|NCT01192022|Secondary|Time to Intraoperative Hemostasis at Target Bleeding Site|The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.|10 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.|||minutes||Full Range|Median
1408614|NCT01192022|Secondary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes|3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 5 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.|||percentage of participants||95% Confidence Interval|Number
1408615|NCT01192022|Primary|Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes|3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.|within 3 minutes|Full Analysis set included all randomized participants analyzed according to the treatment assigned.|||percentage of participants||95% Confidence Interval|Number
1408619|NCT01191944|Other Pre-specified|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at 18 Weeks|ESS is a patient-report scale with 8 items rating how likely one is to fall asleep during passive and inconsequential situations such as watching television, more active situations such as sitting and talking to someone, or consequential situations such as sitting in a car, while stopped for a few minutes in traffic. The likelihood of dozing off is rated from 0 points (no chance) to 3 points (high chance). The overall rating scale is scored from 0 (no daytime sleep) to 24 (worst daytime sleep).|Baseline and week 18|Observed cases (OC). Only patients with ESS assessment at baseline and at 18 weeks were analyzed.|||Units on a scale||Standard Deviation|Mean
1408620|NCT01191944|Secondary|Change From Baseline in UPDRS II Score Separately at Week 18|UPDRS Part II (activities of daily living) ranges from 0 to 52. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF)|||Units on a scale||Standard Error|Least Squares Mean
1408621|NCT01191944|Secondary|Responder in UPDRS Parts II+III Score at Week 18|Responders were defined as patients with at least a 20 percent improvement of UPDRS II+III score relative to baseline. UPDRS II+III ranges 0-160 scores from best to worst and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108).|Baseline and week 18|FAS (LOCF)|||Participants|||Number
1408622|NCT01191944|Secondary|Patient Global Impressions of Improvement (PGI-I) Responder at Week 18|The PGI-I scale is a patient-rated instrument which was used to measure the improvement of a patients PD symptoms throughout the study. Ranging from 1 point=very much better to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much better) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF)|||Participants|||Number
1408623|NCT01191944|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder at Week 18|CGI-I was used to assess the overall status of Parkinsons disease (PD) after interviewing the patient about the various aspects of the PD and after evaluating adverse events and concomitant treatments. Ranging from 1 point=very much improved to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much improved) when comparing the past week to the assessment at baseline.|18 weeks|FAS (LOCF). Only patients with on-treatment CGI-I evaluation were analyzed.|||Participants|||Number
1408624|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18|Duration of on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
1408625|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18|Duration of on-time without Dyskinesia or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
1408626|NCT01191944|Secondary|Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18|Duration on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
1408627|NCT01191944|Secondary|Change From Baseline in Duration of On-time Without Dyskinesia at Week 18|Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
1408628|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18|Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
1408641|NCT01191827|Primary|Neuronal Response During Sensory Gating|Neuronal response (blood oxygenation level dependent functional magnetic resonance imaging signal, relative to the global mean) during sensory gating. Sensory gating is defined as the process of filtering out unnecessary environmental stimuli.|Immediate||||% BOLD signal||Standard Deviation|Mean
1408642|NCT01191801|Other Pre-specified|Leukemia-Free Survival (LFS)|Durability of remission (CR) assessed by LFS|Up to 5 years or the duration of the study|Subset of Intent to Treat patients that have a Measured CR|||Months||95% Confidence Interval|Median
1408629|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18|Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
1408630|NCT01191944|Secondary|Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18|Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
1408631|NCT01191944|Secondary|Change From Baseline in Percentage On-time Without Dyskinesia at Week 18|Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage of on-time||Standard Error|Least Squares Mean
1408632|NCT01191944|Secondary|Responder in Percentage Off-time During Waking Hours at Week 18|Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Participants|||Number
1408633|NCT01191944|Secondary|Change From Baseline in Duration of Off-time During Waking Hours at Week 18|Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||hours||Standard Error|Least Squares Mean
1408634|NCT01191944|Secondary|Change From Baseline in Percentage Off-time During Waking Hours at Week 18|Percentage off-time during waking hours based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|FAS (LOCF) reduced to patients with advanced Parkinsons Disease (PD). Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary.|||Percentage off-time||Standard Error|Least Squares Mean
1408635|NCT01191944|Primary|Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18|UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.|Baseline and week 18|Full analysis set (FAS) with last observation carried forward (LOCF). FAS is defined as all randomised patients which received at least one dose of study drug and provided any post baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
1408636|NCT01191840|Secondary|Antibiotic Days by Treatment Group|This will be analyzed by evaluating the difference in antibiotic days by treatment group and calculating 95% confidence intervals around the difference in antibiotic days among study patients randomized to algorithm-based treatment vs. among study patients randomized to standard treatment.|Test of cure 2 (up to approximately 42 days)|PP (per protocol) population and PPE Population: Patients from the PP population who did not have complicated staphylococcal infection.|||Days||Standard Deviation|Mean
1408637|NCT01191840|Primary|Number of Participants That Changed From Vancomycin to Another Study Antibiotic Due to an Adverse Event|Patient changes from vancomycin or a protocol-approved study antibiotic to another protocol-approved study antibiotic due to AE associated with study drug|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
1408638|NCT01191840|Primary|Number of Participants With Adverse Events Leading to Study Drug Withdrawal|Number of Participants with an Adverse Event leading to study drug withdrawal|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
1408639|NCT01191840|Primary|Number of Participants With Serious Adverse Events|Number of Participants that reported a Serious Adverse Event|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
1408640|NCT01191840|Primary|Cure Rate|To compare the cure rate at Test of Cure evaluation, between the proposed treatment algorithm and the standard of care therapy.|Test of cure 2 (up to approximately 42 days)|Intent-to-treat population|||Participants|||Count of Participants
1408643|NCT01191801|Other Pre-specified|Event Free Survival (EFS)||Up to 5 years or duration of study|Intent to Treat Population|||months||95% Confidence Interval|Median
1408644|NCT01191801|Other Pre-specified|Overall Remission (OR) Rate Based on the IWG Response Criteria|"Group A patient OR compared to Group B patient OR~Overall Remission includes Complete Remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with incomplete blood count recovery (CRi), and Partial Remission (PR). Complete remission means bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts as typically defined by the IWG. Both CRi and CRp refer complete remission but with incomplete blood count and platelet recovery, respectively. PR, or partial remission, refers to remission in which bone marrow contains blast counts between 5 and 25 percent."|Up to 5 years or the duration of the study|Intent to Treat Population|||percentage of participants||95% Confidence Interval|Number
1408645|NCT01191801|Secondary|All Cause Mortality|Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality|60 Days|Safety Population (705)|||percentage of Participants||95% Confidence Interval|Number
1408646|NCT01191801|Secondary|All Cause Mortality|Vosaroxin + cytarabine mortality versus placebo + cytarabine mortality|30 Days|Safety Population (705)|||percentage of Participants in the Group||95% Confidence Interval|Number
1408647|NCT01191801|Secondary|Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.|Group A (Vosaroxin + cytarabine) patient CR as compared to Group B (placebo + cytarabine) patient CR. Complete remission (CR) is typically defined using IWG criteria as bone marrow blast count of less than 5% with adequate recovery of peripheral blood counts.|Up to 5 years or duration of study|The percentage of patients who achieved CR was adjudicated by the CPARR (Central Pathology and Response Review) panel using modified IWG response criteria. The outcome measure reflects the Intent to Treat Population.|||percentage of particpants||95% Confidence Interval|Number
1408648|NCT01191801|Primary|Overall Survival|Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival|Up to 5 years or duration of study|The intent-to-treat (ITT) population which consists of all patients enrolled (randomly assigned to treatment group).|||Months||95% Confidence Interval|Median
1408649|NCT01191788|Secondary|Mental Health Functioning as Measured by SF-12 MCS.|The SF-12 is a 12 question, self-administered measure of general health functioning. The SF-12 outputs a mental health summary score (MCS), which ranges from 0 to 100, with higher scores indicating better mental health functioning. MCS scores are standardized such that mean = 50 and SD = 10 in the general U.S. population.|3 Months Post Treatment||||SF-12 score||Standard Deviation|Mean
1408650|NCT01191788|Primary|Depressive Symptoms as Measured by the Beck Depression Inventory II|The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.|3 Months Post Treatment||||BDI-II score||Standard Deviation|Mean
1408651|NCT01191762|Primary|Fractional Change in [PTH] in CKD After a 4-week Course of Sevelamer Carbonate|This outcome measure documented the effect of intestinal phosphate-binding on [PTH]. Fractional change was calculated as ([PTH]post - [PTH]pre)/[PTH]pre, where 'pre' and 'post' referred respectively to baseline [PTH] (before treatment) and [PTH] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.|4 weeks||||percentage of baseline [PTH]||Standard Error|Mean
1408652|NCT01191749|Primary|Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria|Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks. Response Criteria are according to the Modified IWG Response Criteria in Myelodysplasia. IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count <100 x 10^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10^9/L.|Up to 6 months following treatment; response assessed every 2 months|One subject’s response was indeterminate due to the absence of end of therapy assessments.|||participants|||Number
1408653|NCT01191736|Secondary|The Proportion of Subjects Who Assessed the Responsiveness of the Victim (Manikin) as Judged by Expert Raters|The proportion of the subjects who assessed the responsiveness of the victim (manikin) as judged by expert raters|60 minutes after intervention and two months after intervention||||Proportion of Participants||95% Confidence Interval|Mean
1408654|NCT01191736|Primary|Median Compression Depth (mm)|Assessment of resuscitation skills using a Laerdal Resusci Annie recording manikin and Laerdal PC Skill Reporting software|60 minutes after intervention or two months after intervention|Per protocol|||millimeters||Inter-Quartile Range|Median
1408655|NCT01191723|Secondary|Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours|The heart rate is a measure of how fast or slow the heart beats (measured in beats per minute). A negative change indicates a decrease in heart rate and a positive change indicates an increase in heart rate.|baseline, 30 minutes, and 2 hours|Patients with data available at required time point were included in the analysis population.|||beats per minute (bpm)||Standard Deviation|Mean
1408656|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
1408657|NCT01191723|Secondary|Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes|The Fridericia corrected QT interval(QTcF) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
1408722|NCT01191190|Secondary|Detectable Minimal Residual Disease (MRD)|The patient who achieved a CR did not have detectable MRD in the bone marrow by four-color flow cytometry (<0.1% of cells).|2 years||||participants|||Number
1413503|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||up to 47 days (visit 1 to visit 6)||||Participants|||Number
1408658|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 2 hours|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
1408659|NCT01191723|Primary|Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline and 30 minutes|Patients with data available at required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
1408660|NCT01191476|Secondary|Time to Orientation|Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth).|Every minute after anesthesia was stopped until orientation occurred||||Minutes||Standard Deviation|Mean
1408661|NCT01191476|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred.|Every minute after anesthesia was stopped until extubation occurred|Measurement|||Minutes||Standard Deviation|Mean
1408662|NCT01191476|Secondary|Time to Eye Opening|Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred.|Every minute after anesthesia was stopped until the subjects' eyes opened||||Minutes||Standard Deviation|Mean
1408663|NCT01191476|Secondary|Time to Loss of Consciousness|Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction.|Up to 10 minutes||||seconds||Standard Deviation|Mean
1408664|NCT01191476|Primary|Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane|"[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane];~[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe];~[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].~The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused."|Anesthetic Duration between 1 to 3 Hours|The full analysis set was used for the determination of cost of anesthesia.|||Yuan||Standard Deviation|Mean
1408665|NCT01191411|Primary|Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.|To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value<0.025 will be considered statistically significant.|1 year|Overall, out of 1593 patients assigned to FIT outreach, 648 were screened; out of 479 assigned to colonoscopy outreach, 118 were screened; and out of 3898 assigned to usual care, 471 were screened.|||percentage of participants|||Number
1408666|NCT01191398|Secondary|Monitoring of Adverse Events During Study Administration|Subjects will be monitored for episodes of apnea, laryngospasm, vomiting, oxygen desaturation(<92%), and changes in heart rate and blood pressure. The time frame will include the time the study medication is administered until at least 30 minutes post Ketamine administration.|1 hour||||adverse events|||Number
1408667|NCT01191398|Primary|Difference in Salivary Flow Rate (ml/Min) Between Study Groups|Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)|30 minutes||||ml/min||Standard Deviation|Mean
1408668|NCT01191333|Secondary|Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS)|As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0–60). A high score represents a worse outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
1408669|NCT01191333|Secondary|Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS)|The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
1410447|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1408670|NCT01191333|Secondary|Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS)|The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
1408671|NCT01191333|Secondary|Mean Depression Score as Assessed by Beck Depression Inventory (BDI)|This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state.|Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
1408672|NCT01191333|Secondary|Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS)|To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.|End of acute treatment 4-6 weeks, then end of F/U 6 months|ITT minus participants with missing values|||units on a scale||Standard Deviation|Mean
1408673|NCT01191333|Primary|The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression|The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.|End of acute treatment 4-6 weeks|ITT|||Participants|||Count of Participants
1408674|NCT01191320|Primary|Change in HbA1C|The change in HbA1c from Baseline to 3 Months for each treatment arm|3 months|ITT population|||Ratio||Standard Deviation|Mean
1408675|NCT01191268|Secondary|Number of Participants With Treatment Emergent Adverse Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks, 52 weeks, and 4 weeks after last dose. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks, 52 weeks, and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
1408676|NCT01191268|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 4 weeks after last dose|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
1408677|NCT01191268|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 52 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
1408678|NCT01191268|Secondary|Rate of Self-reported Hypoglycemic Events up to 52 Weeks|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
1408679|NCT01191268|Secondary|Number of Participants With Self-reported Hypoglycemic Events up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions and had a plasma glucose [PG] of ≤ 70 milligrams per deciliter [mg/dL]), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG of ≤ 70 mg/dL), or asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL). The number of participants with self-reported hypoglycemic events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used.|||participants|||Number
1408723|NCT01191190|Secondary|Safety and Tolerability Measured Via Adverse Events|Please see Adverse Event module for additional details.|2 years|Total number of participants who had at least 1 adverse event|||participants|||Number
1408724|NCT01191190|Secondary|Treatment-Free Survival||2 years||||months||Full Range|Median
1408680|NCT01191268|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||events|||Number
1408681|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1408682|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline value as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
1408683|NCT01191268|Secondary|Pulse Rate at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated pulse rate was measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Deviation|Mean
1408684|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline as a covariate|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1408685|NCT01191268|Secondary|Blood Pressure at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured.|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.|||milliliters of mercury (mmHg)||Standard Deviation|Mean
1408686|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.|||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
1408687|NCT01191268|Secondary|Serum Calcitonin at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data.|||picomole per liter||Standard Deviation|Mean
1408688|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||picogram per milliliter (pcg/mL)||Inter-Quartile Range|Median
1408689|NCT01191268|Secondary|Pancreatic Enzymes at Baseline, 52 Weeks, and 4 Weeks After Last Dose|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured at baseline and at 4 weeks after last dose (ALD).|Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data.|||units per liter (U/L)||Standard Deviation|Mean
1408690|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter (U/L)||Inter-Quartile Range|Median
1408691|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Low Blood Sugar Survey (LBSS)|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1408692|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP)|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1408693|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)|"The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline score as a covariate."|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1408694|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, metformin use, and baseline.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1408695|NCT01191268|Secondary|Change From Baseline to 26 Weeks, 52 Weeks, and 4 Weeks After Last Dose in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
1408696|NCT01191268|Secondary|Body Weight at Baseline, 52 Weeks, and 4 Weeks After Last Dose||Baseline and 52 weeks and 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data.|||kilograms (kg)||Standard Deviation|Mean
1408697|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment, and metformin use as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1408698|NCT01191268|Secondary|Total Daily Insulin Dose Overall and by Components (Insulin Lispro and Insulin Glargine)|Total daily insulin (TDI) dose was reported at baseline, 26 weeks, and 52 weeks. Daily Insulin Lispro and Insulin Glargine doses were reported at 26 and 52 weeks.|Baseline and 26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||units||Standard Deviation|Mean
1408699|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose|Fasting serum glucose was measured by the central laboratory. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, metformin use, and treatment-by-visit interaction as fixed effects and baseline fasting blood glucose as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1408725|NCT01191190|Secondary|Progression-free Survival (PFS)||2 years||||months||Full Range|Median
1408785|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|18 weeks after enrollment|The analysis followed the intent-to-treat principle. For missing primary outcome visits (±1 wk), data from a visit 14-27 wks after randomization were used, if available.Multiple imputation(Monte Carlo Markov Chain method) was used for missing 18-wk VA outcomes based on treatment group, baseline VA, and VA scores from completed follow-up visits|||participants|||Number
1408700|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The self-monitored plasma glucose (SMPG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. The mean of the 8 time points (Daily Mean) was also calculated. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMPG data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)]||Standard Error|Least Squares Mean
1408701|NCT01191268|Secondary|Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia|The percentage of participants achieving HbA1c less than 7.0% without nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking) or severe (episodes requiring the assistance of another person to actively administer resuscitative actions) hypoglycemia was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1408702|NCT01191268|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a repeated logistic regression model (generalized estimating equation model) with baseline HbA1c, baseline metformin, country, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1408703|NCT01191268|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1408704|NCT01191268|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1408705|NCT01191255|Secondary|ESA Analysis|Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)|52 weeks||||Units/Day||Full Range|Median
1408706|NCT01191255|Secondary|IV Iron Analysis|Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)|52 weeks||||mg/day||Full Range|Median
1408707|NCT01191255|Secondary|Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52)||52 weeks|Full Analysis Population (LOCF)|||% Saturation||Standard Deviation|Mean
1408708|NCT01191255|Secondary|Change in Mean Serum Ferritin From Baseline to Week 52||52 weeks|Full Analysis Population (LOCF)|||ng/mL||Standard Deviation|Mean
1408709|NCT01191255|Primary|Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56)|Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.|4 weeks|Full Analysis Population (LOCF)|||mg/dL||Standard Deviation|Mean
1408710|NCT01191242|Primary|(R)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408711|NCT01191242|Primary|(R)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408712|NCT01191242|Primary|(S)-EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408713|NCT01191242|Primary|(S)-EDDP Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408714|NCT01191242|Primary|Total EDDP Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408715|NCT01191242|Primary|Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408716|NCT01191242|Primary|(R)-Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408717|NCT01191242|Primary|(R)-Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408718|NCT01191242|Primary|(S)- Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408719|NCT01191242|Primary|(S)- Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408720|NCT01191242|Primary|Total Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408721|NCT01191242|Primary|Total Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
1408726|NCT01191190|Secondary|IwCLL-WG Defined Progressive Disease (PD)|"Responses were assessed two months after completion of therapy~Progressive Disease is defined as:~Greater than or equal to 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be ≥ 2 cm; or the appearance of a new palpable lymph node; OR~Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margins; or appearance of palpable hepatomegaly or splenomegaly, which was not previously present; OR~Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5,000μl; OR~Transformation to a more aggressive histology (i.e., Richter’s syndrome or prolymphocytic leukemia with ≥ 56% prolymphocytes);"|2 months||||participants|||Number
1408727|NCT01191190|Secondary|IwCLL-WG Defined Stable Disease (SD)|"Responses were assessed two months after completion of therapy.~Subjects who do not fulfill the criteria for complete or partial response as defined above but do not exhibit progressive disease will be considered as having stable disease."|2 months||||participants|||Number
1408728|NCT01191190|Secondary|IwCLL-WG Defined Partial Response (PR)|Responses were assessed two months after completion of therapy|2 months||||participants|||Number
1408729|NCT01191190|Secondary|IwCLL-WG Defined Nodular Partial Response (PR)|"Responses were assessed two months after completion of therapy.~Partial Response is defined as:~Greater than or equal to 50% decrease in blood absolute lymphocyte count from pre-treatment value; AND~Greater than or equal to 50% reduction in lymphadenopathy from pre-treatment value; AND~Greater than or equal to 50% reduction in splenomegaly/hepatomegaly from pre-treatment value.~In addition, patients need to have at least ONE of the following:~Neutrophils ≥ 1,500/μl or ≥ 50% improvement from pre-treatment value; AND / OR~Platelets > 100,000/μl or 50% improvement from pre-treatment value; AND / OR~Hemoglobin > 11.0 gm/dl (non-transfused) or 50% improvement from pre-treatment value."|2 months||||participants|||Number
1408730|NCT01191190|Secondary|IwCLL-WG Defined Overall Response Rate (ORR)|Responses were assessed two months after completion of therapy. Overall Response Rate (ORR) = CR + PR|2 months||||participants|||Number
1408731|NCT01191190|Primary|IwCLL-WG Defined Complete Response (CR)|"Responses were assessed two months after completion of therapy.~Criteria for complete remission is assessed with: a bone marrow biopsy and repeat CT scan (abdominal, chest and pelvis if initial was abnormal) to confirm iwCLL-WG defined CR.~iwCLL-WG Complete Response is defined as:~Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 x 109/L (4000/L).~Absence of lymphadenopathy (>1.5 cm)of physical exam; AND~No hepatomegaly and splenomegaly on physical exam; AND~Absence of constitutional symptoms; AND~Normal complete blood count as exhibited by neutrophils ≥ 1,500/μl, platelets > 100,000/μl, hemoglobin > 11.0g/dL (non-transfused), and lymphocyte count < 5,000/μl; AND~Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent"|2 months||||participants|||Number
1408732|NCT01191086|Primary|Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations||Open label treatment of up to 62 weeks|The intent-to-treat (ITT) population was used for all analyses. The ITT population included all subjects who received at least 1 dose of study drug in this extension study.|||participants|||Number
1408733|NCT01191008|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator.|Max 104 weeks|The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.|||Participants|||Number
1408734|NCT01191008|Primary|Clinical Effectiveness Rate|Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks).|Max 104 weeks|The effectiveness analysis set comprised of participants that were excluded off-label uses or blank evaluation from safety analysis set.|||Percentage of participants||95% Confidence Interval|Number
1408735|NCT01191008|Primary|Number of Participants WithTreatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator.|Max 104 weeks|The safety analysis set comprised of participants who had met the inclusion criteria and had received latanoprost/timolol maleate at least once.|||Participants|||Number
1408736|NCT01190891|Secondary|Global Rating of Change|The GROC questionnaire is an instrument that measures overall changes in the quality of life of the subject. The use of a GROC is a common, feasible, and useful method for assessing outcome, and has been shown to be a valid measurement of change in patient status in other pain populations. A change in score of three rating points has been established as a clinically significant in the patients perception of quality of life. The GROC has 15 possible choices, with 0 being equal to no change and -1 to -7 indicating a negative change and +1 to +7 indicating a positive change.|1 year||||units on a scale||95% Confidence Interval|Mean
1408737|NCT01190891|Primary|Shoulder Pain and Disability Index|The SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability), with higher scores indicating greater pain and disability. It is responsive to change and accurately discriminates between patients who are improving or worsening. It has high test-retest reliability and internal consistency. The minimal detectable change (MDC) is 18 and the minimally clinically important difference (MCID) is between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.|1 year||||units on a scale||95% Confidence Interval|Mean
1408738|NCT01190878|Primary|Ocular Inflammation|"Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells."|15 days|Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.|||participants|||Number
1408739|NCT01190865|Secondary|Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.|"The biopsy area was examined for the presence of the Y chromosome, based on the presence of a full set of Y-STR loci as well as partial sets, assayed by a commercial kit (AmpFISTRTM).~Probit analysis was utilized to determine the time in days to 50% correct identification (ID50) of the implanted male DNA 17 loci in female volunteers, with regard to three DNA profile types, including partial DNA profile, > 50% DNA profile, and full (or complete) DNA profile. The analysis was performed using SAS® PROC PROBIT"|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|The analysis population consisted of the 8 cohorts of 3 subjects biopsied at weekly intervals over the 8-week duration of the study. It should be note that the cohort for Week 8 (Day 57) was composed of 4 subjects|||Days||95% Confidence Interval|Number
1408740|NCT01190865|Primary|Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.|The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.|Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks|3 subjects were withdrawn; 2 for non-compliance and one at the subject's request. One subject, who was available to replace a subject assigned to a weekly cohort if the subject was unavailable, was assayed on Day 57 with the subjects assigned to the Week 8 cohort.|||Participants|||Count of Participants
1408741|NCT01190839|Secondary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD]before or at Week 104 were considered to have clinical recurrence.|Baseline up to Week 104|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.|||percentage of participants|||Number
1408742|NCT01190839|Secondary|Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76|Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned one of the treatment.|||percentage of participants|||Number
1408743|NCT01190839|Primary|Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76|CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD] before or at Week 76 were considered to have clinical recurrence.|Baseline up to Week 76|Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.|||percentage of participants|||Number
1408744|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment||||letters||Standard Deviation|Mean
1408745|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.|||participants|||Number
1408746|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.|||letters||Standard Deviation|Mean
1408780|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|16 weeks after enrollment||||participants|||Number
1408781|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks|Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.|10 weeks after enrollment||||participants|||Number
1408747|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 26 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity.|26 weeks after enrollment|All participants continued in the study regardless of whether they continued with study medication after the 18-week visit; 49 participants in the levodopa group and 24 participants in the placebo group continued study medication at the 18-week visit.|||participants|||Number
1408748|NCT01190813|Secondary|Mean Systemic Adverse Events||Enrollment through 26 weeks||||events||Standard Deviation|Mean
1408749|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408750|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408751|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408752|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408753|NCT01190813|Secondary|Mean Parent Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408754|NCT01190813|Secondary|Mean Parent Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment||||units on a scale||Standard Deviation|Mean
1408755|NCT01190813|Secondary|Mean Child Symptom Survey Score at 26 Weeks|A treatment group comparison of symptom survey scores at the 26 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|26 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408756|NCT01190813|Secondary|Mean Child Symptom Survey Score at 18 Weeks|A treatment group comparison of symptom survey scores at the primary outcome (18 week) visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|18 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408757|NCT01190813|Secondary|Mean Child Symptom Survey Score at 16 Weeks|A treatment group comparison of symptom survey scores at the 16 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|16 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408758|NCT01190813|Secondary|Mean Child Symptom Survey Score at 10 Weeks|A treatment group comparison of symptom survey scores at the 10 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|10 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408759|NCT01190813|Secondary|Mean Child Symptom Survey Score at 4 Weeks|A treatment group comparison of symptom survey scores at the 4 week visit. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|4 weeks after enrollment||||units on a scale||Standard Deviation|Mean
1408760|NCT01190813|Secondary|Mean Child Symptom Survey Score at Enrollment|A treatment group comparison of symptom survey scores at enrollment. The average of the overall item responses will be calculated and compared by treatment group with a t-test for difference in means. A higher number reflects a more negative response (5=always, 4=often, 3=sometimes, 2=rarely, 1=never).|At enrollment||||units on a scale||Standard Deviation|Mean
1408761|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||letters||Standard Deviation|Mean
1408782|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|4 weeks after enrollment||||participants|||Number
1408783|NCT01190813|Secondary|Mean Amblyopic Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||letters||Standard Deviation|Mean
1408762|NCT01190813|Primary|Mean Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.~Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.|||letters||Standard Deviation|Mean
1408763|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity Change From Baseline at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||participants|||Number
1408764|NCT01190813|Secondary|Mean Fellow Eye Visual Acuity at 18 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|18 weeks after enrollment||||letters||Standard Deviation|Mean
1408765|NCT01190813|Secondary|Distribution of Fellow Eye Visual Acuity at 18 Weeks|Similar to the analysis for the amblyopic eye, the fellow eye visual acuity will be evaluated to determine if study treatment had an adverse effect on the occluded eye. The analysis will be a treatment group comparison of the mean fellow eye visual acuity at 18 weeks after enrollment, adjusted for baseline acuity.|18 weeks after enrollment||||participants|||Number
1408766|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 26 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 26 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment||||letters||Standard Deviation|Mean
1408767|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 26 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|26 weeks after enrollment||||participants|||Number
1408768|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 16 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 16 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment||||letters||Standard Deviation|Mean
1408769|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 16 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|16 weeks after enrollment||||participants|||Number
1408770|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 10 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment||||letters||Standard Deviation|Mean
1408771|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 10 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|10 weeks after enrollment||||participants|||Number
1408772|NCT01190813|Secondary|Mean Change in Amblyopic Eye Visual Acuity From Baseline at 4 Weeks|A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity.|4 weeks after enrollment||||letters||Standard Deviation|Mean
1408773|NCT01190813|Secondary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 4 Weeks|Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.|4 weeks after enrollment||||participants|||Number
1408774|NCT01190813|Secondary|Amblyopia Resolution at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|26 weeks after enrollment||||participants|||Number
1408775|NCT01190813|Secondary|Amblyopia Resolution at 18 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|18 weeks after enrollment||||participants|||Number
1408776|NCT01190813|Secondary|Amblyopia Resolution at 16 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|16 weeks after enrollment||||participants|||Number
1408777|NCT01190813|Secondary|Amblyopia Resolution at 10 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|10 weeks after enrollment||||participants|||Number
1408778|NCT01190813|Secondary|Amblyopia Resolutionat 4 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.|4 weeks after enrollment||||participants|||Number
1408779|NCT01190813|Secondary|Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks|Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.|26 weeks after enrollment||||participants|||Number
1408786|NCT01190813|Primary|Distribution of Amblyopic Eye Visual Acuity Change From Baseline|"The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity.~Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line."|18 weeks after enrollment|The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, & VA scores from completed follow-up visits.|||participants|||Number
1408787|NCT01190566|Secondary|Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography||Baseline, post-1st chemotherapy||||unitless||Standard Deviation|Mean
1408788|NCT01190566|Secondary|Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy|Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.|Baseline, post-1st chemotherapy|Of the 48 participants, 13 participants did not undergo magnetic resonance spectroscopy examinations due to workflow problem. We included the available data from 35 participants.|||unitless||Standard Deviation|Mean
1408789|NCT01190566|Secondary|Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)||Baseline, post-1st chemotherapy||||unitless||Standard Deviation|Mean
1408790|NCT01190566|Secondary|Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)||Baseline, post-1st chemotherapy||||min-1||Standard Deviation|Mean
1408791|NCT01190566|Secondary|Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)||Baseline, post-1st chemotherapy||||min-1||Standard Deviation|Mean
1408792|NCT01190566|Secondary|Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)|Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.|Baseline, post-1st chemotherapy||||% of voxels||Standard Deviation|Mean
1408793|NCT01190566|Secondary|Tumor Volume|Tumor volume measured on 3-dimensional magnetic resonance imaging|Baseline, post-1st chemotherapy||||cm3||Standard Deviation|Mean
1408794|NCT01190566|Secondary|Tumor Size|Maximal tumor diameter measured on magnetic resonance imaging|baseline, completion of 1st cycle of chemotherapy||||cm||Standard Deviation|Mean
1408795|NCT01190566|Primary|Patholocial Response to Chemotherapy|Pathological complete response (pCR) or non-pCR|Post-operation||||participants|||Number
1408796|NCT01190527|Secondary|The Number of Participants That Experience Lung Toxicity and Esophagitis|The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.|2 years||||participants|||Number
1408797|NCT01190527|Secondary|Percentage of Patients Alive at 2 Years|Overall survival of all patients will be estimated|2 years||||percentage of patients||95% Confidence Interval|Number
1408798|NCT01190527|Secondary|Number of Patients That Were Able to Receive Dose Escalation|The number of patients for which dose escalation was possible will be reported.|2 Years||||participants|||Number
1408799|NCT01190527|Primary|2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)|Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.|2 years||||percentage of patients||95% Confidence Interval|Number
1408800|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Mean
1408801|NCT01190514|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Mean
1408802|NCT01190514|Secondary|Terminal Elimination Half-life (t 1/2)|Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.|||hours||Standard Deviation|Mean
1408803|NCT01190514|Primary|Maximum Plasma Concentration (Cmax)|Cmax measured as nanograms divided by milliliters (ng/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Mean
1408804|NCT01190514|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|PK population; N=number of participants contributing to the median.|||hours||Full Range|Median
1408820|NCT01190436|Secondary|Percentage of Participants With Increased Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. Percentage of participants with increased HbA1c (greater than 0.5% from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1419598|NCT01102374|Secondary|Change in Parathyroid Hormone Level||Baseline and 12 months|Issue relating to sample collection/processing precluded measurement of PTH level in the trial||||||
1408805|NCT01190514|Primary|Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)|Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose|Pharmacokinetic parameter analysis (PK) population: all participants randomized and treated and had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Mean
1408806|NCT01190475|Secondary|Measure: To Evaluate the Pharmacokinetic Profile of BGS649 Following Multiple Dosing at Two Dose Levels Over 3 Months in Pre-menopausal Women With Moderate to Severe Endometriosis.||8 months (Assess PK profile from first dosing through end of study and compare PK on Day 1 of first dose to that of third month)|||||||
1408807|NCT01190475|Primary|Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger|Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.|8 months|Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger|||Participants|||Count of Participants
1408808|NCT01190449|Secondary|Median Progression-free Survival Time|The median progression-free survival (PFS) time for each arm was estimated using the Kaplan-Meier method. PFS was calculated as the time from study entry until progression or death, whichever occurred first. Patients were censored at the time last known alive and progression free. Lymph nodes should be considered abnormal if the long axis is > 1.5 cm, regardless of the short axis. If a lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is > 1.0. Lymph nodes ≤ 1.0 cm by ≤ 1.0 cm will not be considered as abnormal for relapse or progressive disease. Progression is defined using the 2007 revised response criteria reported by Cheson et al. as follows: Appearance of any new lesion, At least a 50% increase from nadir in the SPD of any previously involved nodes, At least a 50% increase in the longest diameter of any single previously identified node > 1.0 cm in its short axis.|From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 years|Patients who completed the study and were not ineligible were included in this analysis.|||years||95% Confidence Interval|Median
1408809|NCT01190449|Primary|Overall Response Rate (Complete or Partial Response) by Month 12|The primary endpoint of this trial is overall response rate (OR=complete response (CR) or partial response (PR)) to 500 mg or 1000 mg dose of ofatumumab in previously untreated patients with CD20+ follicular NHL. The response outcome is defined as the best response during the 12 months of first-line and extended induction treatment. A CR is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is defined as at least a 50% decrease in the sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, with no increase observed in the size of other nodes, liver, or spleen and no new sites of disease should be observed. The ORR (percentage of patients) reported below by arm is the percentage of patients whose best response during the 12 months of treatment was CR or PR.|From baseline to month 12|Patients who completed the study and were not ineligible were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
1408810|NCT01190436|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.|Baseline up to Week 12|ITT population included all participants who received at least 1 dose of study drug.|||participants|||Number
1408811|NCT01190436|Secondary|Mean Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Week 12|The change in total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at Week 12 minus total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level at baseline, respectively.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||mg/dL||Standard Deviation|Mean
1408812|NCT01190436|Primary|Percentage of Participants With Decrease in Heart Rate by at Least 10 Bpm at Week 12||Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1408813|NCT01190436|Secondary|Mean Change From Baseline in Fasting Blood Sugar (FBS) Level at Week 12|The change in FBS level at Week 12 was calculated as FBS level at Week 12 minus FBS level at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||mg/dL||Standard Deviation|Mean
1408814|NCT01190436|Secondary|Percentage of Participants With Increased Fasting Blood Sugar (FBS) at Week 12|Percentage of participants with increased FBS (greater than 16 milligram per deciliter [mg/dL] from baseline) at Week 12 was reported.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1408815|NCT01190436|Primary|Mean Change From Baseline in Heart Rate at Week 12|The change in heart rate at Week 12 was calculated as the heart rate at Week 12 minus heart rate at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||beats per minute (bpm)||Standard Deviation|Mean
1408816|NCT01190436|Primary|Percentage of Participants With Response to Study Drug|Response to study drug was defined as lowering of systolic BP by at least 10 mmHg from baseline.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1408817|NCT01190436|Primary|Percentage of Participants With Controlled BP|Controlled BP was defined as BP less than 130/80 mmHg.|Week 12|ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1408818|NCT01190436|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 12|The change in diastolic and systolic BP at Week 12 was calculated as diastolic and systolic BP at Week 12 minus diastolic and systolic BP at baseline, respectively.|Baseline, Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.|||mmHg||Standard Deviation|Mean
1408819|NCT01190436|Secondary|Mean Change From Baseline in HbA1c at Week 12|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Week 12 was calculated as HbA1c at Week 12 minus HbA1c at baseline.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug.|||Percent HbA1c||Standard Deviation|Mean
1408823|NCT01190267|Primary|Number of Participants Who Discontinued Study Drug During Extension Study Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 26 weeks|All participants who received at least one dose of extension study medication|||participants|||Number
1408824|NCT01190267|Primary|Number of Participants With a Treatment-Emergent Adverse Event (AE) During Extension Study|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was defined as a “treatment-emergent” AE if it was not present at the extension study baseline, or if it was present at the extension study baseline but worsened in severity compared to baseline during the extension study treatment period.|Up to 30 weeks|All participants who received at least one dose of extension study medication|||participants|||Number
1408825|NCT01190254|Secondary|Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q overall score score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408826|NCT01190254|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used a last-observation-carried-forward (LOCF) approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q total score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408827|NCT01190254|Secondary|Change From Baseline in Children’s Global Assessment Scale (CGAS) Score at Day 56|CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 56; improvement in functioning is represented by positive values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGAS score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408828|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study|CGI-I response was defined as the occurrence of a CGI-I score of 1 (very much improved) or 2 (much improved). CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. The Kaplan-Meier estimate reports the cumulative percentage of participants with CGI-I response from first drug intake up to approximately Day 58.|Baseline up to approximately Day 58|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||cumulative % of participants w/ Response|||Number
1408829|NCT01190254|Secondary|CGI-I Responders|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at the last available assessment of the study for that participant (i.e., endpoint). CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||participants|||Number
1408830|NCT01190254|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Day 56|CGI-I is a 7-point scale for assessing the global improvement of the participant’s illness relative to baseline, with ratings from 1=very much improved to 7=very much worse.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included an on-treatment Day 56 value of the CGI-I score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1410319|NCT01178671|Secondary|PTSD Self-rated Severity|as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe).|up to 24 weeks|completers|||units on a scale||Standard Deviation|Mean
1408831|NCT01190254|Secondary|Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study|A total PANSS 30% response was defined as a reduction from baseline of at least 30% in the PANSS Total score. The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The Kaplan-Meier estimate reports the cumulative percentage of participants with total PANSS 30% response from first drug intake up to approximately Day 59.|Baseline up to approximately Day 59|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||cumulative % of participants w/ Response|||Number
1408832|NCT01190254|Secondary|Total PANSS 30% Responders|A Total PANSS 30% responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS Total score at the last available assessment of the study for that participant (i.e., endpoint). The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline up to Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS).|||participants|||Number
1408833|NCT01190254|Secondary|Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder anxiety/depression factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder anxiety/depression factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408834|NCT01190254|Secondary|Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder hostility/excitement factor score for each participant was calculated as the sum of the rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder hostility/excitement factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408835|NCT01190254|Secondary|Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder disorganized thoughts factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder disorganized thoughts factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408836|NCT01190254|Secondary|Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder negative symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder negative symptoms factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408853|NCT01190215|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Ratio||95% Confidence Interval|Geometric Mean
1408837|NCT01190254|Secondary|Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56|This measure reports results for the 8 items of the Marder positive symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items (Marder et al. J Clin Psychiatry 1997;58(12):538-46). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder positive symptoms factor score for each participant was calculated as the sum of the rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder positive symptoms factor score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408838|NCT01190254|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS general psychopathology subscale score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408839|NCT01190254|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56|This measure reports results for the combined positive subscale (7 items) and negative subscale (7 items) of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each of the total 14 items in the combined positive and negative subscales, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive and negative subscale scores combined for each participant was calculated as the sum of the rating assigned to each of the 14 combined subscale items, and ranged from 14 to 98 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive/negative subscale scores combined must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408840|NCT01190254|Secondary|Change From Baseline in PANSS Negative Subscale Score at Day 56|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS negative subscale score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408841|NCT01190254|Secondary|Change From Baseline in PANSS Positive Subscale Score at Day 56|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive subscale score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408842|NCT01190254|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56|Change from baseline in CGI-S score at Day 56 is the Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant’s illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGI-S score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408887|NCT01190150|Primary|The Ratio of AUC0-t to AUCinf|Comparison of AUC0-t to AUCinf by creating a ratio.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.|||ratio of AUC0-t / AUCinf||Standard Deviation|Mean
1408843|NCT01190254|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.|Baseline and Day 56|Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 56 value of PANSS Total Score must be available for a participant.|||score on a scale||Standard Deviation|Mean
1408844|NCT01190228|Primary|Number of Participants With Solicited Injection-Site Reactions and Systemic Reactions Following a Dose of Live Attenuated JE-CV or Varicella Vaccine|Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection-site reactions: Pain, Incapacitating, unable to perform usual activities. Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, 39.0°C; Headache, Malaise, and Myalgia, Significant; prevents daily activities.|Day 0 up to Day 14 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
1408845|NCT01190228|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Year 1, 2, 3, 4, and 5 post-vaccination|Geometric mean titer ratios of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titer ratios (1/dilution)||95% Confidence Interval|Geometric Mean
1408846|NCT01190228|Primary|Summary of Geometric Mean Titer of JE Virus Antibodies Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Day 0 (pre-vaccination) and Days 7 and 28 and Year 1, 2, 3, 4, and 5 post-vaccination|Geometric mean titers of JE virus antibodies were assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1408847|NCT01190228|Primary|Percentage of Participants With JE Seroprotection Before and Up to 5 Years Following a Booster Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Days 7 and 28 and Years 1, 2, 3, 4, and 5) was defined as neutralizing antibody titer ≥ 10 (1/dilution).|Day 0 (pre-vaccination) and Days 7 and 28, and Year 1, 2, 3, 4, and 5 post-vaccination|Seroprotection was assessed in the Full Analysis Set. Data for JE-CV Vaccine First Dose and Varicella Vaccine Groups were not analyzed for this outcome measure as pre-specified in the study protocol.|||Percentage of participants|||Number
1408848|NCT01190228|Primary|Summary of Serological Flavivirus Status at Baseline of Participants Vaccinated With a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Flavivirus positive was defined as titers against JE virus ≥10 (1/dilution) or titers against at least 1 dengue serotype ≥10 (1/dilution). Flavivirus negative was defined as titers against JE virus <10 (1/dilution) and titers against the 4 dengue serotypes <10 (1/dilution).|Day 0 (pre-vaccination)|Serological flavivirus status at baseline was assessed in the Full Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Number of participants|||Number
1408849|NCT01190228|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titer ratios (1/dilution)||95% Confidence Interval|Geometric Mean
1408850|NCT01190228|Primary|Summary of Geometric Mean Titers of JE Virus Antibodies Following a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay.|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1408851|NCT01190228|Primary|Percentage of Participants With JE Seroconversion Following a Dose of Live Attenuated JE-CV Vaccine|The presence of JE virus neutralizing antibodies was measured using a PRNT50 assay. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or participants with pre vaccination titer ≥10 (1/dilution) and a ≥4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Seroconversion was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Percentage of participants|||Number
1408852|NCT01190228|Primary|Percentage of Participants With JE Seroprotection Before and Following a Dose of Live Attenuated JE-CV|The presence of JE virus neutralizing antibodies was measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before (on Day 0) and after JE-CV vaccination (Day 7 and Day 28) was defined as neutralizing antibody titer ≥ 10 (1/dilution).|Day 0 (pre-vaccination) and Day 7 and Day 28 post-vaccination|Seroprotection against JE-CV vaccine was assessed in the Per Protocol Analysis Set. Data for Varicella Vaccine Group were not analyzed for this outcome measure as pre-specified in the study protocol.|||Percentage of participants|||Number
1408911|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|week 48||||participants|||Number
1419599|NCT01102374|Secondary|Change in 25-hydroxyvitamin D (25OHD) Level||Baseline and 12 months||||ng/mL||Standard Error|Mean
1408854|NCT01190215|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
1408855|NCT01190215|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
1408856|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408857|NCT01190215|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408858|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Special Interest.|Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408859|NCT01190215|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).|Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408860|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Up to Month 6)|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408861|NCT01190215|Secondary|Number of Subjects Reporting Medically-attended Events (MAEs).|For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|Within the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408862|NCT01190215|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination."|Within 28 days (Day 0 – Day 27) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408863|NCT01190215|Secondary|Number of Days With Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.~Grade 3 symptom = general symptom that prevented normal activity.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
1408864|NCT01190215|Secondary|Number of Days With Any Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
1408865|NCT01190215|Secondary|Number of Days With Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain and swelling.~Grade 3 redness/swelling = redness/swelling above 50 millimetres.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
1408866|NCT01190215|Secondary|Number of Days With Any Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling.~Inter-quartile range assessed was the 25th percentile and the 75th percentile."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
1408912|NCT01190124|Primary|HIV-RNA Levels|Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|week 24||||participants|||Number
1408913|NCT01190124|Primary|HIV-RNA Levels|Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline||||participants|||Number
1419600|NCT01102374|Secondary|Time to First ARI||12 months||||Hazard Ratio|||Number
1408867|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).~Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius."|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408868|NCT01190215|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.|Within 7 days (Day 0 – Day 6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1408869|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.~Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
1408870|NCT01190215|Secondary|Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.~Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
1408871|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||titre||95% Confidence Interval|Geometric Mean
1408872|NCT01190215|Secondary|Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||titre||95% Confidence Interval|Geometric Mean
1408873|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Ratio||95% Confidence Interval|Geometric Mean
1408874|NCT01190215|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Ratio||95% Confidence Interval|Geometric Mean
1408875|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
1408876|NCT01190215|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
1408914|NCT01190098|Secondary|Change in Quality of Life in Epilepsy (QOLIE-31) From Baseline to Visit 4|Range 0 -10 where higher scores reflect better quality of life.|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
1408877|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
1408878|NCT01190215|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.~Day 28 data were presented for the Fluarix Group only."|At Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
1408879|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Subjects|||Number
1408880|NCT01190215|Secondary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.~Day 28 data were presented for the Fluarix Group only."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
1408881|NCT01190215|Primary|Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.~Day 28 data was presented only for the Fluarix Group."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Subjects|||Number
1408882|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and at Month 6|Analysis was performed on According-to-Protocol (ATP) cohort for antibody persistence at Month 6 which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at Month 6.|||Titres||95% Confidence Interval|Geometric Mean
1408883|NCT01190215|Primary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.|"Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).~Day 28 data were presented only for the Fluarix Group.~Titres were expressed as geometric mean antibody titre."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Titres||95% Confidence Interval|Geometric Mean
1408884|NCT01190215|Secondary|Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.|"Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.~Day 28 data were presented for the Fluarix Group only.~Titres were expressed as geometric mean antibody titres (GMTs)."|At Day 0 and Day 28|The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.|||Titres||95% Confidence Interval|Geometric Mean
1408885|NCT01190150|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Treatment-emergent AEs are summarized by total participants with TEAEs, participants with serious TEAEs, participants with TEAEs deemed by the investigator to be related to treatment, and participants who experienced TEAEs that caused permanent discontinuation from the study.|Day 1 up to week 4|The Safety Population consisted of all randomized participants who received at least one dose of tranexamic acid.|||participants|||Number
1408886|NCT01190150|Primary|Elimination Half-life (t ½)|Apparent first-order terminal elimination half life|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||hours||Standard Deviation|Mean
1408915|NCT01190098|Secondary|Change in Daily Seizure Frequency From Baseline to Visit 4|Number of seizures per day.|Baseline to visit 4 (approximately 1 - 2 months)|2 subjects did not complete seizure diary at both time points.|||number of seizures per day||Inter-Quartile Range|Median
1408888|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|Dose-normalized AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.|||μg*h/mL||Standard Deviation|Mean
1408889|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to Infinity (AUCinf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUCinf is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population including all participants with three or more non-zero plasma concentrations. One participant withdrew on Day 7 and did not meet the requisite samples required for this PK parameter.|||μg*h/mL||Standard Deviation|Mean
1408890|NCT01190150|Primary|Dose Normalized Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg*h/mL||Standard Deviation|Mean
1408891|NCT01190150|Primary|Area Under the Concentration Versus Time Curve From 0 to the Last Time Point (AUC0-t)|The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear trapezoidal method.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg*h/mL||Standard Deviation|Mean
1408892|NCT01190150|Primary|Time to Maximum Concentration Level (Tmax)|Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||hours||Standard Deviation|Mean
1408893|NCT01190150|Primary|Dose-normalized Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified and normalized to the 1.3 g dose.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg/mL||Standard Deviation|Mean
1408894|NCT01190150|Primary|Maximum Concentrations Level (Cmax)|Cmax is the maximum measured plasma concentration over the time-span specified.|Day 1 or Day 8 (before dosing and at the following times thereafter: 0.5, 0.75, 1, 2, 2.5, 3.0, 3.5, 4, 5, 6, 10, 14, and 24 hours post-dose)|Plasma PK population includes all participants with at least one quantifiable PK concentration.|||μg/mL||Standard Deviation|Mean
1408895|NCT01190124|Secondary|Adverse Drug Reactions|Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.|Week 48||||participants|||Number
1408896|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 48.|week 48||||cells/mm^3||Full Range|Median
1408897|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at week 24.|week 24||||cells/mm^3||Full Range|Median
1408898|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48||||participants|||Number
1408899|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24||||participants|||Number
1408900|NCT01190124|Secondary|HIV-RNA Levels|For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline||||participants|||Number
1408901|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 48.|Week 48||||cells/mm^3||Full Range|Median
1408902|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at week 24.|Week 24||||cells/mm^3||Full Range|Median
1408903|NCT01190124|Secondary|CD4 Cells Count|For the HIV-2 infected patients CD4 cells count will be assessed at baseline.|Baseline||||cells/mm^3||Full Range|Median
1408904|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.|Week 48||||cells/mm^3||Full Range|Median
1408905|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.|Week 24||||cells/mm^3||Full Range|Median
1408906|NCT01190124|Secondary|CD4 Cells Count|For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.|Baseline||||cells/mm^3||Full Range|Median
1408907|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.|Week 48||||participants|||Number
1408908|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.|Week 24||||participants|||Number
1408909|NCT01190124|Secondary|HIV-RNA Levels|For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.|Baseline||||participants|||Number
1408910|NCT01190124|Primary|CD4 Cells Count|CD4 cells count at baseline.|Baseline||||cells/mm^3||Full Range|Median
1408916|NCT01190098|Secondary|Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline to Visit 4.|Range 0-27, where higher scores indicate more impairment (depressive symptoms)|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
1408917|NCT01190098|Secondary|Change in Adverse Event Profile (AEP) From Baseline to Visit 4.|Range 19-76, where higher scores indicate more severe impairment (in terms of 19 common antiepileptic drug side effects.|Baseline to visit 4 (approximately 1 - 2 months)|3 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
1408918|NCT01190098|Secondary|Change in Functional Outcomes of Sleep Questionnaire (FOSQ) From Baseline to Visit 4.|Range 0-20 where lower scores indicate more impairment (sleep related QOL).|Baseline to visit 4 (approximately 1 - 2 months)|5 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
1408919|NCT01190098|Secondary|Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Visit 4|Range 0-21, where higher scores more impairment (in terms of sleep quality).|Baseline to Visit 4 (approximately 1 - 2 months)|7 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
1408920|NCT01190098|Secondary|Change in the Fatigue Severity Scale From Baseline to Visit 4.|Fatigue Severity Scale (FSS): Range 7- 63 where higher scores indicate more severe fatigue.|Baseline to Visit 4 (approximately 1 - 2 months)|6 subjects did not complete enough questions on the tool for the total score to be calculated at both time points.|||units on a scale||95% Confidence Interval|Mean
1408921|NCT01190098|Primary|Change in Epworth Sleepiness Scale Score From Baseline to Visit 4|Scale 0 - 24 Higher scores indicate more severe symptoms|Baseline and Visit 4 (approximately 1 - 2 months)||||Units on a scale||95% Confidence Interval|Mean
1408922|NCT01190085|Primary|Salivation|Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of psychophysiological responses, namely salivation changes.|approximately 30 minutes after drug administration||||gram||Standard Deviation|Mean
1408923|NCT01190085|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability.|Whether ghrelin intravenous (i.v.), as compared to saline i.v., does not significantly increase Adverse Events (AEs).|participants will be followed after the cue-reactivity experiment, an expected average of 7 days||||participants|||Number
1408924|NCT01190085|Primary|Alcohol Visual Analogue Scale (A-VAS)|"Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Visual Analogue Scale (A-VAS)].~The A-VAS was rated on 11-point anchored Likert-type scales, where 0 is the minimum score (no craving) and 11 is the maximum score (highest craving intensity). The change in the A-VAS score (deltaA-VAS) was used to indicate decrease (-d) or increase (+d) in craving intensity."|approximately 30 minutes after drug administration||||units on a scale||Standard Deviation|Mean
1408925|NCT01190007|Secondary|Percent Change From Baseline in Apolipoprotein B at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of Apolipoprotein B||Standard Deviation|Mean
1408926|NCT01190007|Secondary|Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Ratio||Standard Deviation|Mean
1408927|NCT01190007|Secondary|Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|Value at each visits minus value at baseline|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Ratio||Standard Deviation|Mean
1408928|NCT01190007|Secondary|Percent Change From Baseline in Triglyceride (TG) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Week 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of TG||Standard Deviation|Mean
1408929|NCT01190007|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of HDL-C||Standard Deviation|Mean
1408930|NCT01190007|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of TC||Standard Deviation|Mean
1408931|NCT01190007|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit|"Value at each visits minus value at baseline divided by value at baseline multiplied by 100"|Weeks 4, 12, 24, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||Percentage of LDL-C||Standard Deviation|Mean
1408966|NCT01189617|Primary|"Number of Subjects With Irritation Score of 0 at Baseline and One Week"|Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.|Baseline and One Week|Full Analysis Set|||Participants|||Number
1408932|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment.~Participants with both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia."|||mmHg||Standard Deviation|Mean
1408933|NCT01190007|Secondary|Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||mmHg||Standard Deviation|Mean
1408934|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. Participants both angina pectoris and hypercholesterolemia were included the participants with all of angina pectoris, hypertension and hypercholesterolemia.|||mmHg||Standard Deviation|Mean
1408935|NCT01190007|Secondary|Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia|Value at each visits minus value at baseline|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|The efficacy analysis set included all participants who took at least one dose of study drug and contributed data to baseline and at least one post-baseline efficacy assessment. LOCF means Last Observation Carried Forward.|||mmHg||Standard Deviation|Mean
1408936|NCT01190007|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|52 weeks|The safety analysis set included all participants who took at least one dose of study drug.|||Participants|||Number
1408937|NCT01189890|Secondary|LS Mean Change From Baseline in Participant Body Weight at Week 30|Participants were only permitted to wear a drape gown and undergarments (no street clothes, no shoes or socks) for this evaluation. Body weight was measured after voiding (to the nearest 0.1 kg) and measurements were collected until 2 consecutive measurements did not differ by more than 0.2 kg from each other. Body weight measurements were evaluated using a standardized, calibrated digital scale and was reported in kilograms (kg) at baseline and Week 30.|Baseline and Week 30|All randomized participants who received at least one dose of study treatment and had body weight measurements at baseline and at Week 30.|||kg||95% Confidence Interval|Least Squares Mean
1408938|NCT01189890|Secondary|Percentage of Participants With HbA1c <6.5% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <6.5% at Week 30. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||Percentage of Participants|||Number
1408939|NCT01189890|Secondary|Percentage of Participants With HbA1c <7.0% at Week 30|Participant whole blood samples were collected at Week 30 to determine the number of participants achieving HbA1c <7.0% at Week 30. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Week 30|The population included all randomized participants who had HbA1c at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||Percentage of Participants|||Number
1408940|NCT01189890|Secondary|LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG.|Baseline and Week 30|The population included all randomized participants who had a FPG value at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
1408941|NCT01189890|Primary|Number of Participants Discontinuing Study Treatment Due to An AE|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.|||Participants|||Number
1408942|NCT01189890|Primary|Number of Participants Experiencing An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the~study treatment, whether or not considered related to the use of the treatment administered."|Up to Week 30|All randomized participants who received at least one dose of study treatment.|||Participants|||Number
1408943|NCT01189890|Primary|Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30|Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms.|Up to Week 30|All randomized participants who received at least one dose of study treatment.|||Participants|||Number
1410320|NCT01178671|Secondary|Alternative Measure of PTSD Severity|as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe)|up to 24 weeks|completers|||units on a scale||Standard Deviation|Mean
1408944|NCT01189890|Primary|Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30|Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.|Baseline and Week 30|The population included all randomized participants who had a baseline HbA1c, had a HbA1c at Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.|||Percentage of HbA1c||95% Confidence Interval|Least Squares Mean
1408945|NCT01189812|Secondary|Beck Scale for Suicide Ideation (BSS)|"The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny.~Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4"|4 weeks|||||||
1408946|NCT01189812|Secondary|Beck Hopelessness Scale (BHS)|"The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts.~Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4"|4 weeks|||||||
1408947|NCT01189812|Primary|Sheehan-Suicidality Tracking Scale (S-STS)|"The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide.~Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4."|4 weeks; from Baseline to Week 4|The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40).|||Scores on a Scale (S-STSS)|Participants|Standard Deviation|Mean
1408948|NCT01189760|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from Baseline for FLO-11 Question #8: “My facial lines make me look tired.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 3 are included.|||Percentage of participants|||Number
1408949|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: “My facial lines make me look less attractive than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.|||Percentage of participants|||Number
1408950|NCT01189760|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: “When I look in the mirror, my facial lines make me look older than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only participants with a Baseline score ≥ 2 are included.|||Percentage of participants|||Number
1408951|NCT01189760|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|Participants were considered to judge themselves as looking younger if the category change was from “look my current age” at Baseline to “look younger” at Day 30 or from “look older” at Baseline to “look my current age/younger” at Day 30.|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."|||Percentage of participants|||Number
1408952|NCT01189760|Secondary|Subject Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow’s Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
1408953|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Only those participants who were rated at least mild at Baseline are included in the analyses.|||Percentage of participants|||Number
1408954|NCT01189760|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1409096|NCT01188772|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12.|Week 4 to Week 12|Safety Analysis Set|||percentage of participants|||Number
1408955|NCT01189760|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1408956|NCT01189760|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.|||Percentage of participants|||Number
1408957|NCT01189747|Secondary|Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|The percentage of FLO-11 Item #8 responders, defined as participants with a ≥ 3-point improvement in FLO-11 score from baseline for FLO-11 Question #8: “My facial lines make me look tired” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 3 were included.|||Percentage of participants|||Number
1408958|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|The percentage of FLO-11 Item #5 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #5: “My facial lines make me look less attractive than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.|||Percentage of participants|||Number
1408959|NCT01189747|Secondary|Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|The percentage of FLO-11 Item #2 responders, defined as participants with a ≥ 2-point improvement in FLO-11 score from Baseline for FLO-11 Question #2: “When I look in the mirror, my facial lines make me look older than I want to look.” The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much).|Baseline, Day 30|Intent-to-treat population consisted of all randomized participants. Only subjects with Baseline scores ≥ 2 were included.|||Percentage of participants|||Number
1408960|NCT01189747|Secondary|Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline|Participants were considered to judge themselves younger if the category change was from “look my current age” at Baseline to “look younger” at Day 30 or from “look older” at Baseline to “look my current age/younger” at Day 30.|Baseline, Day 30|"Intent-to-treat population included all randomized participants. Only those participants who rated themselves as look my current age or look older at Baseline are included in the analyses."|||Percentage of participants|||Number
1408961|NCT01189747|Secondary|Subject Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) Score|Patients rated the change in their Crow’s Feet Lines using the SGA-CFL 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. Lower scores indicate improvement.|Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
1408962|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Rest|The Investigator assessed the severity of the patient's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat participants included all randomized participants. Only participants who were rated at least mild at Baseline are included in the analyses.|||Percentage of participants|||Number
1408963|NCT01189747|Secondary|Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Maximum Smile|The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥ 1-grade improvement from Baseline at Day 30 is reported.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1408964|NCT01189747|Secondary|Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator’s Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1408965|NCT01189747|Primary|Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile|The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at Day 30. The Investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.|Baseline, Day 30|Intent-to-treat population included all randomized participants. Participants with missing values are considered non-responders.|||Percentage of participants|||Number
1408967|NCT01189604|Secondary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)||||Participants|||Number
1408968|NCT01189604|Secondary|Blood Concentrations of Propofol|Blood concentration of ICI35,868 (propofol)|At the end of the initiation period and every 2 minutes during the maintenance period||||µg/mL||Standard Deviation|Mean
1408969|NCT01189604|Secondary|Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire|The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).|24 - 48 hours after completion of the procedure||||Units on a scale||Standard Deviation|Mean
1408970|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|4 minutes from the beginning of the maintenance period||||Participants|||Number
1408971|NCT01189604|Primary|Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period|The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5.|2 minutes from the beginning of the maintenance period||||Participants|||Number
1408972|NCT01189500|Secondary|Plasma 4-hydroxy-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
1408973|NCT01189500|Secondary|Plasma N-desmethyl-tamoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
1408974|NCT01189500|Secondary|Plasma Endoxifen (Metabolite) Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
1408975|NCT01189500|Secondary|Plasma Tamoxifen Concentration Versus Time Summary: Tamoxifen Alone and When Coadministered With DVS SR|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.250 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing|PK concentration analysis population: all participants randomized and treated who had at least 1 concentration in at least 1 treatment period. N=number of participants contributing to the median. Period 2 / Day 1 = Day 1 of Tamoxifen dosing (Period 2 / Day 7) within the DVS SR, Tamoxifen coadministration dosing period.|||ng/mL||Full Range|Median
1408976|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
1408977|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
1408978|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Error|Mean
1409097|NCT01188772|Secondary|Percentage of Participants With Complete Early Virologic Response at Week 12|Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12|Week 12|Safety Analysis Set|||percentage of participants|||Number
1408979|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
1408980|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1408981|NCT01189500|Secondary|4-hydroxy-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|4-hydroxy-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1408982|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
1408983|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
1408984|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Error|Mean
1408985|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
1408986|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1408987|NCT01189500|Secondary|N-desmethyl-tamoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|N-desmethyl-tamoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1408988|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
1408989|NCT01189500|Secondary|Endoxifen (Metabolite) Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
1408990|NCT01189500|Secondary|Endoxifen (Metabolite) Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Deviation|Mean
1408991|NCT01189500|Secondary|Endoxifen (Metabolite) Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
1408992|NCT01189500|Secondary|Endoxifen (Metabolite) Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1408993|NCT01189500|Secondary|Tamoxifen Apparent Volume of Distribution (Vz/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||liters||Standard Deviation|Geometric Mean
1408994|NCT01189500|Secondary|Tamoxifen Apparent Clearance (CL/F) Following Tamoxifen Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||mL/min||Standard Deviation|Geometric Mean
1408995|NCT01189500|Secondary|Tamoxifen Terminal Half-life (t 1/2) Following Tamoxifen Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Standard Deviation|Mean
1408996|NCT01189500|Secondary|Tamoxifen Time for Cmax (Tmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the median.|||hours||Full Range|Median
1408997|NCT01189500|Secondary|Tamoxifen Maximum Observed Concentration (Cmax) Following Tamoxifen Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1408998|NCT01189500|Primary|Endoxifen (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Endoxifen Alone and When Coadministered With DVS SR|Endoxifen is a metabolite of Tamoxifen. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|PK parameter analysis population. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1408999|NCT01189500|Primary|Tamoxifen Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Tamoxifen Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12,16, 24, 48, 72, 120, 168, 216, 264, 312, 384, 456, and 528 hours after dosing; Period 2 / Day 1 and Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours; 0 hour on Day 8, 9, 10, 12, 14, 16, 18, 20, 23, 26 and 29.|Pharmacokinetic (PK) parameter analysis population: all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1409000|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."|||percentageof participants||95% Confidence Interval|Number
1409014|NCT01189292|Secondary|Postoperative Pain After Physical Stress|"Compare grade of pain between the treatment (dexamethasone) and the control (saline) group~Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1~before obtaining the pain rating, patients were asked to turn their heads (physical stress)"|4 and 8 hours after surgery|intention to treat analysis|||units on a scale||Standard Deviation|Mean
1410321|NCT01178671|Primary|Time to Discontinuation of Study Treatment||up to 24 weeks||||days||Standard Deviation|Mean
1409001|NCT01189487|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment."|Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1409002|NCT01189487|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment.|Day 4|Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.|||percentage of participants|||Number
1409003|NCT01189487|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants EXCLUDING ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1409004|NCT01189487|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)|"Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1409005|NCT01189461|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)|VA indicated sharpness or clarity of vision. BCVA assessed by early treatment diabetic retinopathy study chart using 4 meter (m), 1m distance, or if participant was able to count fingers, perceive hand motion or light. At 4m (>= 20 letters), VA score=number of letters correct plus 30 (credited for 30 letters at 1m); otherwise , VA score=number of letters read correctly at 1m plus number read at 4m (if any). If no letters were read correctly at 4m or 1m, VA score= 0, which were excluded from summary statistics calculation. BVCA score ranged: 0 (poor eyesight) to 78 (best eyesight).|Baseline, Week 48 (End of treatment)|Full analysis set included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies participants who had BVCA score greater than 0 at baseline and 'n' signifies those who were evaluable at each specified time point.|||units on a scale||Standard Deviation|Mean
1409006|NCT01189461|Primary|Mean Total Number of Injections|Mean number of injections per participant was calculated as (number of injection administered per participant – 1)/duration of treatment. Mean number of injections administered for total participants was summarized.|Baseline up to Week 48 (End of treatment)|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||injections||Standard Deviation|Mean
1409007|NCT01189461|Secondary|Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Total number of participants who had ocular and non-ocular SAEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1409008|NCT01189461|Primary|Incidence of Ocular and Non-Ocular Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Total number of participants who had ocular and non-ocular AEs was reported.|Baseline up to 30 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Same participant may be represented in more than 1 category.|||participants|||Number
1409009|NCT01189435|Primary|To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib|in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib|2 years|||||||
1409010|NCT01189370|Secondary|Overall Number of Participants That Had Disease Progression on Study|Disease Progression as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|26 months||||Participants|||Count of Participants
1409011|NCT01189370|Primary|Number of Participants Who Could Tolerate Each Dose Level|Tolerability will be defined as successful completion of the dose level without experiencing Grade 3 or 4 toxicity.|12 weeks||||Participants|||Count of Participants
1409012|NCT01189292|Secondary|Necessary Anesthesiological Medication|Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group|measured from beginning of anaesthesia to end of anaesthesia||||milligram||Standard Deviation|Mean
1409013|NCT01189292|Secondary|Length of Hospital Stay|Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group|Difference between day of admission and day of discharge|intention to treat|||hour||Standard Deviation|Mean
1410705|NCT01175850|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of amputations|||Number
1409017|NCT01189292|Secondary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)~any PONV event within 48 hours after surgery~PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery (PP)|per protocol analysis|||percentage of participants||95% Confidence Interval|Number
1409018|NCT01189292|Primary|Incidence of Postoperative Nausea and Vomiting|"Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)~any PONV event within 48 hours after surgery~PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery"|within 48 hours after surgery|intention to treat analysis|||percentage of participants||95% Confidence Interval|Number
1409019|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment|Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication|||Patients|||Number
1409020|NCT01189279|Secondary|Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment|Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.|Baseline, 20 Days|Safety Population: all subjects who received at least 1 dose of study medication|||Patients|||Number
1409021|NCT01189279|Secondary|Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings|An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm.|17 Days|Safety Population: all subjects who received at least 1 dose of study medication|||Percentage of Patients|||Number
1409022|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost|Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|17 Days|Per Protocol: all subjects with no major protocol deviations|||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
1409023|NCT01189279|Primary|Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost|Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.|Day 1|Per Protocol: all subjects with no major protocol deviations|||Picograms/Milliliter (pg/mL)||Standard Deviation|Mean
1409024|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15. Only 4 pts samples were evaluable for AUC 24 at the10mg dose.|||ng*h/mL||Standard Deviation|Mean
1409025|NCT01189240|Secondary|Measurement of AUC24 to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.|24hrs|Day 1|||ng*h/mL||Standard Deviation|Mean
1409026|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 15|all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the 15th day of treatment during cycle 1.|24hr|Day 15 only. Level 2 10mg only had 5pts with evaluable PKs at day 15|||ng/mL||Standard Deviation|Geometric Mean
1409027|NCT01189240|Secondary|Measurement of Cmax to Determine the Effect of Bevacizumab on the Plasma Pharmacokinetics of RO4929097 Day 1|"all pts at all dose levels (5,10 and 20mg) will have pks collected. 10 samples will be collected at various time points over a 24 hour time point. Samples will be collected on the first day of treatment during cycle 1.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected"|24 hrs|Day One only|||ng/mL||Standard Deviation|Geometric Mean
1409028|NCT01189240|Secondary|Toxicity Description (Dose Limiting Toxicity-DLT) of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort. Pts must receive one dose of treatment to be evaluated for toxicity. Toxcity description associated with combination of RO4929097 and Bevacizumab|28 days - 1 cycle|DLT Defintion, must be related to RO and/or Bev: ANC </= 500/μL or second time ANC <1,000/μL; PLTs </= 25,000/μL or second time platelets <50,000/μL; Febrile neutropenia;Thrombocytopenic bleeding (platelets <50,000/μL and with clinically significant bleeding); Delay of treatment > 14 days ;grade 3 or 4 non-hematological toxicity (some exceptions)|||participants|||Number
1409029|NCT01189240|Primary|Maximum-tolerated Dose and the Recommended Phase II Dose of Gamma-secretase Inhibitor RO4929097 in Combination With Bevacizumab Determined by Dose-limiting Toxicity Rate (Phase I)|Pts were treated at escalating dose levels of RO4929097 (Dose levels: 5, 10 or 20 mg) for an observed evaluation at the end of a 4week period. 3 pts treated at each cohort if less than or equal to 33% dose will be escalated. Pts must receive one dose of treatment to be evaluated for toxicity. A standard 3+3 dose escalation method will be used|28 days|RO4929097 Days 1-3 weekly (doses 5,10, 20 mg) + Bev 10mg/kg IV q2 wks - cycle 28 days. 3+3 dose escalation method will be used. Target DLT is > or equal to 33%|||mg|||Number
1409030|NCT01189227|Secondary|Frequencies of Adverse Events as Assessed by the NCI CTCAE v4.0||From study entry through 3 months after the last treatment dose.|||||||
1409036|NCT01189201|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Time frame for adverse event was until the end-of-study examination.|Drug administration until next treatment period/end-of-study examination, up to 36 days|Treated set (TS) included all subjects who were documented to have taken at least one dose of investigational treatment.|||participants|||Number
1409037|NCT01189201|Primary|Linagliptin Formulation Comparison: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409038|NCT01189201|Primary|Linagliptin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1409039|NCT01189201|Secondary|Linagliptin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409040|NCT01189201|Primary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409041|NCT01189201|Primary|Empagliflozin Formulation Comparison: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1409042|NCT01189201|Secondary|Empagliflozin Formulation Comparison: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409043|NCT01189201|Primary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409044|NCT01189201|Primary|Linagliptin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1419601|NCT01102374|Secondary|Severity of Acute Respiratory Infections|ARIs resulting in emergency department visits or hospitalizations|12 month||||events|||Number
1409045|NCT01189201|Secondary|Linagliptin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409046|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409047|NCT01189201|Primary|Empagliflozin Fed vs Fasted: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma, comparing fed with fasted.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1409048|NCT01189201|Secondary|Empagliflozin Fed vs Fasted: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409049|NCT01189201|Secondary|Linagliptin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409050|NCT01189201|Secondary|Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409051|NCT01189201|Secondary|Linagliptin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of linagliptin in plasma|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Full Range|Median
1409052|NCT01189201|Secondary|Empagliflozin: Time From Last Dosing to Maximum Measured Concentration (Tmax)|Time from last dosing to the maximum measured concentration of empagliflozin (empa) in plasma.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||hours||Full Range|Median
1409053|NCT01189201|Primary|Linagliptin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of linagliptin in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1409098|NCT01188772|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29)|Week 4|Safety Analysis Set|||percentage of participants|||Number
1409054|NCT01189201|Primary|Empagliflozin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1409055|NCT01189201|Primary|Linagliptin: Area Under the Curve 0 to 72 Hours (AUC0-72)|"Area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 hours.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409056|NCT01189201|Primary|Empagliflozin: Area Under the Curve 0 to the Last Quantifiable Drug Plasma Concentration (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.~In this endpoint, the “measured values“ show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration|Pharmacokinetic (PK) set: Included all subjects who were documented to have taken at least one dose of investigational treatment, who provided at least one observation for at least one primary endpoint without important protocol violations relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1409057|NCT01189136|Other Pre-specified|Pain From Treatment|Patient-reported discomfort attributable to the study intervention (0-10 Likert scale, with higher numbers representing greater pain)|30 minutes||||units on a scale||Standard Deviation|Mean
1409058|NCT01189136|Other Pre-specified|Questionnaire Data - Impression of Allocation|"Participants were asked to guess to which treatment arm they had been allocated (PTNS Sham or I Don't Know). Outcome was measured as the number of patients in each arm accurately determining their allocation."|30 minutes|Number|||number of participants|||Number
1409059|NCT01189136|Secondary|Amount of Improvement in Voiding Efficiency|Improvement of voiding efficiency, as measured by dividing the volume voided by the total volume (voided volume + retained volume) per participant. Each participant is evaluated separately, and the mean percentage of improvement was calculated for each arm.|30 minutes||||percentage of voided vol/total volume||Standard Deviation|Mean
1409060|NCT01189136|Primary|Persistent Retention|Number of participants with persistent unsuccessful trial of void after the intervention|30 minutes||||participants|||Number
1409061|NCT01189123|Secondary|Antibody Responses|Hemagglutination inhibition antibody titers measured for standard vs high dose|2 years||||GMT||95% Confidence Interval|Geometric Mean
1409062|NCT01189123|Primary|Cellular Immune Response|comparison of CMI in high vs standard dose|3 years|A subset of samples were chosen for testing since not enough money was available to test samples from all subjects. The samples were divided by randomization group (blinded to study staff -- they were called group A or group B). From each group, samples were randomly pulled.|||percentage of Stimulated cells||Inter-Quartile Range|Median
1409063|NCT01189110|Primary|Percentage of Self-reported Abstinence at 6 Weeks.|Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).|6 weeks|A middle-aged, US military veteran population not free of smoking (at least 10 cigarettes per day) and not currently in reciept of any other form of smoking cessation intervention.|||percentage of participants||95% Confidence Interval|Number
1409064|NCT01189071|Secondary|Decreased Use of Narcotic and Anticholinergic Medication Use Postoperatively.|"Decreased use of narcotic and anticholinergic medication use postoperatively, compared to the standard of care patient"|end of study with 30 patients recruited|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.||||||
1409065|NCT01189071|Primary|Decreased Post Operative Ureteral Stent Pain, Evidenced by Decreased Pain Scores, Less ER Visits/Hospital Admits, or Patient Phone Calls for Stent Pain/Difficulty|"Decreased post operative ureteral stent pain, evidenced by decreased pain scores, less ER visits/hospital admits, or patient phone calls for stent pain/difficulty, as compared to the standard of care patient with no preop Darifenacin"|24 months|Three participants were recruited to the study, but no data were collected or analyzed as the author of the study left the institution and the study was terminated.||||||
1409066|NCT01189032|Primary|Mean Change in Fluorescein Staining Score From Baseline|"Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.~The degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area."|Baseline and 4-week (discontinued(LOCF))|"Efficacy analysis was performed per protocol set (PPS). Excluded cases were 7 subjects (3 subjects in 3% group, 3 subjects in 1% group, and 1 subject in Placebo group).~The reason of exclusion: used the prohibited concomitant drug, dosing period shortage, number of doses non-compliance, or had no available efficacy data."|||points||Standard Deviation|Mean
1409067|NCT01188967|Secondary|Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications|"The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo two weeks after discontinuation of double blind study medications.~7-day, Point-prevalence tobacco abstinence was defined as not smoking for the 7 consecutive days before this visit after discontinuation of double blind study medications"|Week 10 of the study|7 participants completed this visit.|||Participants|||Count of Participants
1409068|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of 6 weeks exposure to GSK598809/placebo.|Week 8 of the study|7 participants completed week 6 weeks exposure to GSK598809/placebo.|||Participants|||Count of Participants
1409069|NCT01188967|Secondary|7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of the first week of exposure to GSK598809/placebo.|Week 3 of the study|13 participants completed week 1 visit|||Participants|||Count of Participants
1409070|NCT01188967|Primary|4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase|The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)|Week 8 of the study|9 participants completed this visit|||Participants|||Count of Participants
1409071|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 8|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 8 weeks||||percentage of change in PASI||Standard Deviation|Mean
1409072|NCT01188928|Secondary|Mean Percentage Change in PASI From Baseline to Week 4|At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.|Baseline and 4 weeks||||percentage of change in PASI||Standard Deviation|Mean
1409073|NCT01188928|Primary|Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 8|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|week 8||||participants|||Number
1409074|NCT01188928|Primary|Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 4|The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.|4 weeks||||participants|||Number
1409075|NCT01188876|Secondary|Area Under the Plasma Drug Concentration-Time Curve (AUC)|Area under the plasma drug concentration-time curve (AUC) for phase 1 participants that were dosed at 105 mg/m2. AUC represents the actual body exposure to drug after administration of a dose of the drug and is expressed in micrograms * hour per milliliter (ug*h/mL).|Day 1 and Day 15|Participants that required a dose reduction due to an adverse event were excluded from the day 15 evaluation|||ug*h/mL||95% Confidence Interval|Mean
1409076|NCT01188876|Secondary|Maximum Concentration of Drug in Plasma (Cmax)|The maximum concentration of Pralatrexate at day 1 and 15 among phase 1 participants dosed at 105 milligrams per square meter of body surface area (mg/m2). The concentration is given in micrograms per milliliter.|Day 1 and Day 15|Participants that required a dose reduction due to an adverse event were excluded from the day 15 evaluation|||ug/ml||95% Confidence Interval|Mean
1409077|NCT01188876|Secondary|Treatment Related Adverse Events|Summary of the treatment related adverse events experienced by participants as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4). Adverse events were assessed from the start of treatment until 30 days after the last dose of study drug.|1 Year||||Participants|||Count of Participants
1409078|NCT01188876|Secondary|Progression Free Survival|The number of participants alive and without disease progression at the given time-points. Time is measured from the start of treatment. Progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|3 months, 6 months||||Participants|||Count of Participants
1409079|NCT01188876|Secondary|Overall Survival|The number of participants still alive at the given time points. The duration of time is measured from the start of treatment until death due to any cause, participants are censored at the date of the last evaluation. The number participants surviving at 6, 12, 18, and 24 months is shown.|6, 12, 18, and 24 months||||Participants|||Count of Participants
1409080|NCT01188876|Primary|Best Overall Response|"Summary of the best overall responses to treatment as assessed by RECIST (Response Evaluation Criteria In Solid Tumors).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|1 Year||||Participants|||Count of Participants
1409095|NCT01188772|Secondary|Percentage of Participants With Virologic Response at the End of Treatment|End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit.|Week 48 (genotype 1) or Week 12 (genotype 2/3)|Participants in the Safety Analysis Set with available data were analyzed. One participant in the Sofosbuvir 400 mg (Genotype 2/3) Group was lost to follow up before the end of treatment and is not included in this analysis.|||percentage of participants|||Number
1409081|NCT01188876|Primary|Maximum Tolerated Dose (MTD)|The maximum tolerated dose of Pralatrexate in combination with Carboplatin in this patient population. The unit is given in milligrams per square meter of body surface area. MTD was determined using a standard 3 + 3 dose escalation cohort, where 3 participants were enrolled on the starting dose of 30 mg/m2 and if no dose limiting toxicities (DLT) were experienced after a full cycle, 3 additional participants were enrolled at the next highest dose level. Each increase in dose level escalated the dose of Pralatrexate by 15 mg/m2. If during any dose level, 1 patient out of 3 develops a DLT, then 3 additional patients will be added to that dose level. If 2 out of the 3 patients placed on any dose level experience a DLT, the preceding dose is considered MTD. If 1/6 has a DLT, the next higher dose level will commence accrual (unless at level +5 and then accrual to the Phase I portion will stop). If ≥ 2 of 6 patients have a DLT, then the preceding dose will be considered MTD.|1 year|The participants that participated in the phase 1 dose escalation portion of the study|||mg/m^2|||Number
1409082|NCT01188811|Secondary|Safety Measure: Adverse Events||adverse events recorded from baseline to year 2|Intention-to-treat analysis was performed on 27 participants in the lipoic acid group and 24 in the placebo group.|||occurences|||Number
1409083|NCT01188811|Secondary|Disability Measures: Mobility||Change in Timed 25 Foot Walk from baseline to year 2|Outliers were removed and intention-to-treat analysis was performed on data from 21 participants in the lipoic acid group and 17 in the placebo group.|||seconds||Standard Deviation|Mean
1409084|NCT01188811|Primary|Brain Atrophy by MRI||% change brain volume from baseline to year 2|22 subjects in the lipoic acid group and 24 in the placebo group completed the MRI outcome. Two outliers in the lipoic acid group were not included in analysis.|||whole brain percent volume change||Standard Deviation|Mean
1409085|NCT01188798|Secondary|Assess Overall Survival, Relapse, Engraftment, and Regimen-related Morbidity and Estimating Cumulative Incidence of Pulmonary Adverse Events and Mucositis.|To characterize the pharmacokinetic-pharmacodynamic relationships of pentostatin in this patient population and to assess the relationship between pre-transplant minimal residual disease (MRD) and transplant outcomes.|42 days post- transplant|Insufficient data was available to answer objectives.||||||
1409086|NCT01188798|Primary|Determining Whether the Hepatic Adverse Event-free (NCI Grades II-IV) Survival at Day 42 After an HLA-matched Transplant for Hematologic Malignancy Can be Improved by Using a GVHD Prophylaxis Regimen That Includes Pentostatin Rather Than MTX.|The hypothesis was that individuals receiving the drug pentostatin as GVHD prophylaxis would experience less severe hepatic toxicity than those receiving methotrexate as GVHD prophylaxis. The study is estimated to have sufficient statistical power to ascertain at least a 20% improvement in day 42 grade 2 or above hepatic toxicity-free survival in pentostatin recipients|42 days post-transplant|Insufficient data was available to answer objectives||||||
1409087|NCT01188772|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir|Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24.|Baseline to Week 12|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.|||percentage of participants|||Number
1409088|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.|||ng•h/mL||Standard Deviation|Mean
1409089|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.|||ng•h/mL||Standard Deviation|Mean
1409090|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.|||ng•h/mL||Standard Deviation|Mean
1409091|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.|||ng/mL||Standard Deviation|Mean
1409092|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.|||ng/mL||Standard Deviation|Mean
1409093|NCT01188772|Secondary|Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)|The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.|1, 2, 4, 8, and 12 hours postdose|Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.|||ng/mL||Standard Deviation|Mean
1409094|NCT01188772|Secondary|Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)|SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively.|Post-treatment Weeks 12 and 24|Safety Analysis Set|||percentage of participants|||Number
1409099|NCT01188772|Secondary|Change in HCV RNA From Baseline to Week 12||Baseline to Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
1409100|NCT01188772|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 12 plus 30 days|Safety Analysis Set: participants were randomized and received at least one dose of study drug|||percentage of participants|||Number
1409101|NCT01188694|Primary|PTSD Symptom Severity-Interview (PSS-I)|PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)|Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)|Intent to Treat|||units on a scale||Standard Deviation|Mean
1409102|NCT01188681|Secondary|Response Per NCI Criteria|Overall response rate per National Cancer Institute (NCI) Working group criteria.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Safety data for all patients who received any study drug and efficacy data for randomized patients who received some study treatment and have some post baseline data are presented here.|||percentage of patients|||Number
1409103|NCT01188681|Primary|Response Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria|Patients had full clinical response assessment monthly during treatment, at the end of treatment (EOT) visit, 30 and 60 days after the EOT visit, and subsequently every 3 months until the earliest of progression of CLL, death, initiation of new therapy, withdrawal from the study, or completion of 18 months of follow-up evaluations. Clinical response assessment included physical examination with measurement of spleen, liver, and lymph nodes, disease-related symptoms, and laboratory measurements, specifically complete blood count (CBC) with differential.|1 and 2 months after end of treatment, then every 3 months until disease progression, death, initiation of new therapy, study withdrawal, or 2 years|Treated patients|||percentage of patients|||Number
1409104|NCT01188668|Secondary|Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.|||ng/mL||Full Range|Median
1409105|NCT01188668|Secondary|Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg|Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Period 1 / Day 1 and Period 2 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing|PK concentration analysis population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period. Period 2 / Day 1 = Day 1 of Aripiprazole dosing (Period 2 / Day 7) within the DVS SR, Aripiprazole coadministration dosing period.|||ng/mL||Full Range|Median
1409106|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||liters||Standard Deviation|Geometric Mean
1409107|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. Data was insufficient for analysis; not analyzable.|||mL/min||Standard Deviation|Geometric Mean
1409108|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||hours||Standard Deviation|Mean
1409109|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=number of participants contributing to the mean.|||hours||Full Range|Median
1409110|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR||Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing|PK parameter analysis population. N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1409124|NCT01188655|Secondary|Mean Duration of Morning Stiffness|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes (24h x 60 minutes) was recorded).|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||minutes||Standard Deviation|Mean
1409111|NCT01188668|Secondary|Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Dehydro-aripiprazole is a metabolite of Aripiprazole. Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1409112|NCT01188668|Secondary|Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Calculated as Dose / (AUCinf * kel); where kel=terminal phase rate constant.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||liters||Standard Deviation|Geometric Mean
1409113|NCT01188668|Secondary|Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood calculated as (Dose/AUCinf); measured as milliliters per minute (mL/min).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||mL/min||Standard Deviation|Geometric Mean
1409114|NCT01188668|Secondary|Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||hours||Standard Deviation|Mean
1409115|NCT01188668|Secondary|Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Time for maximum observed plasma concentration.|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the median.|||hours||Full Range|Median
1409116|NCT01188668|Secondary|Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|PK parameter analysis population. N=Number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1409117|NCT01188668|Primary|Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20|Pharmacokinetic (PK) parameter analysis population: all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=Number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1409118|NCT01188655|Secondary|Spine Agility Function by Ott Test|The Ott index determines the agility of the thoracic spine.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||cm||Standard Deviation|Mean
1409119|NCT01188655|Secondary|Spine Agility Function by Schober Test|Schober test determines agility of lumbar spine. It measures participant’s ability to flex the lower back. Examiner makes a mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch the toes. Examiner measures the increase in distance between 2 fingers.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||cm||Standard Deviation|Mean
1409120|NCT01188655|Secondary|Mean Occiput-to-wall Distance at Week 12 and Week 24||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||cm||Standard Deviation|Mean
1409121|NCT01188655|Secondary|Percentage of Participants Without Peripheral Arthritis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Percentage of Participants|||Number
1409122|NCT01188655|Secondary|Percentage of Participants Without Enthesitis||Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Percentage of Participants|||Number
1409123|NCT01188655|Secondary|Change From Baseline in ASQoL at Week 12 and Week 24|ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Units on a scale||Standard Deviation|Mean
1409125|NCT01188655|Secondary|Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm= no disease activity.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||mm||Standard Deviation|Mean
1409126|NCT01188655|Secondary|Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24|Measured using a 100mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Units on a scale||Standard Deviation|Mean
1409127|NCT01188655|Secondary|Change From Baseline in the BASFI at Weeks 12 and 24|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||Units on a scale||Standard Deviation|Mean
1409128|NCT01188655|Secondary|Change From Baseline in BASDAI at Week 12 and 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.|Baseline, Week 12 and Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point.|||units on a scale||Standard Deviation|Mean
1409129|NCT01188655|Primary|Percentage of Participants Achieving BASDAI 40 Response at Week 24|BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10. Participants who achieved a decrease of 40 percent or more from baseline to the following visits are called as responders.|Week 24|Safety population: all participants who recieved at least one dose of study medication during the study period, n equals number of participants analyzed at the given time point|||Percentage of participants|||Number
1409130|NCT01188603|Primary|Flibanserin: Tmax,ss|Median of the tmax,ss of Flibanserin|8 days|All patients with values for the time from dosing to the maximum measured concentration of flibanserin in plasma after single dose at steady state (tmax,ss)|||h||Full Range|Median
1409131|NCT01188603|Primary|Flibanserin: Cmax,ss|Geometric mean of the Cmax,ss of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1409132|NCT01188603|Primary|Flibanserin: Cmax (Peak Concentration)|Geometric mean of the Cmax of Flibanserin|8 days|All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1409133|NCT01188603|Primary|Flibanserin: AUC τ,ss|Geometric mean of the AUC τ,ss of Flibanserin|8 days|All patients with values for the area under the concentration-time curve of the analyte in plasma over a dosing interval τ at steady state (AUC τ,ss)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1409134|NCT01188603|Primary|Flibanserin: Area Under the Curve; AUC_0-∞|Geometric mean of the AUC_0-∞ of Flibanserin|8 days||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1409135|NCT01188577|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
1409136|NCT01188577|Primary|Half-life (t1/2) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine to decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Full Range|Mean
1409137|NCT01188577|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Standard Deviation|Mean
1409152|NCT01188460|Secondary|Hospital Anxiety and Depression Scale (HADS)|Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
1419602|NCT01102374|Primary|Number of Acute Respiratory Infections (ARIs)|ARIs defined as upper or lower respiratory infections|12 months||||events|||Number
1409138|NCT01188577|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg*min/mL||Standard Deviation|Mean
1409139|NCT01188577|Primary|Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurements btw 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
1409140|NCT01188577|Primary|Baseline Concentration (C0) of Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study drug treatment 3) have at least three of the four post-dose PK measurement btwn 2 and 10 min post-dose available and 4) have a minimum of twelve of the fifteen post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
1409141|NCT01188564|Secondary|Time to Minimal Symptoms|"The key secondary efficacy endpoint was the time to minimal symptoms at all locations. The time to achieving minimal symptoms was defined as an answer of Yes to TEQ question 3."|24 hours||||minutes||Full Range|Median
1409142|NCT01188564|Primary|Time to Beginning of Relief of Symptoms|"Time to beginning of relief is the time lapsed from the beginning of the infusion of study medication to the beginning of a beneficial effect based on patient's responses to the Treatmetn Effect Questionnaire (TEQ) for the primary attack location. The beginning of relief is defined as the first timepoint at which~The patient reports any of the following answers for TEQ question 1: A little better, Better or Much better; and;~The patient reports the following answer for TEQ question 2: Yes; and,~There is persistence in improvement at the next assessment time, i.e.either the same or a better response to Question 1 and Yes to Question 2."|Patients observed for 24 hours||||minutes||95% Confidence Interval|Median
1409143|NCT01188551|Secondary|Recovery From General Anesthesia|Post-anesthesia recovery score: Aldrete The Aldrete scoring system takes into account the patient's ability to move, respiration, circulation, consciousness, and oxygen saturation. A maximum of two points are awarded in each category and a score of 9 or 10 is required for discharge.|30 mins. post-op||||units on a scale||Standard Deviation|Mean
1409144|NCT01188551|Primary|FLACC Behavioral Pain Assessment Scale Scores|"FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10.~0 = Relaxed and comfortable 1–3 = Mild discomfort 4–6 = Moderate pain 7–10 = Severe discomfort or pain or both"|30 mins. post-op||||units on a scale||Standard Deviation|Mean
1409145|NCT01188538|Secondary|Percent Change (%) in Inflammatory Lesion Counts|Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated.|Week 12|ITT (LOCF)|||Percent change (%)||Full Range|Median
1409146|NCT01188538|Primary|Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes|"Quantitative bacterial examinations were performed on the subjects’ face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes.~Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study."|Week 12|Intent To Treat (ITT)/Last Observation Carried Forward (LOCF)|||Log10 cfu/cm²||Standard Deviation|Mean
1409147|NCT01188499|Secondary|Evaluation of Pharmacokinetics and Translational Biomarkers|Measurement of TL32711 pharmacokinetics: Maximum plasma concentration (Cmax), area under the curve (AUC), half-life (t1/2) and assessment of translational biomarkers in plasma, PBMC's and tumor biopsies. Gene expression profiling of tumor tissue.|Cycle 1 and Cycle 2|||||||
1409148|NCT01188499|Secondary|Evaluation of Anti-tumor Efficacy|Tumor burden according to Response Evaluation Criteria in Solid Tumors (RECIST) and time to progression|Every 2 cycles|Intent-to-treat (ITT)|||participants|||Number
1409149|NCT01188499|Primary|Number of Subjects With Adverse Events as a Measure of Safety and Tolerability|Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters|1 Cycle (3-4 weeks)||||participants|||Number
1409150|NCT01188460|Secondary|Fatigue Severity Scale (FSS)|Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
1409151|NCT01188460|Secondary|Pre-Sleep Arousal Scale (PSAS)|Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes|Timepoint 2 (week 7 of study participation).||||units on a scale||Standard Deviation|Mean
1410390|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients With Diabetic Disease|ID-TVF rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1409160|NCT01188460|Primary|Insomnia Severity Index (ISI)|Measures insomnia symptoms, scores range from 0-28 with higher scores (ranging from 15-28) indicating clinical insomnia and therefore worse outcomes|Timepoint 2 (week 7 of study participation)||||units on a scale||Standard Deviation|Mean
1409161|NCT01188447|Secondary|Average Contact Time|Total time spent with patient (Defined as difference between Transfer of Care and Arrival at Patient Side)|immediately following evaluation|In order to be included in this analysis, and to have Contact Time calculated, both the paramedic arrival time and transfer of care time were required. Any case missing this information could not be included in the calculation.|||minutes||Full Range|Mean
1409162|NCT01188447|Secondary|Scene Time|Time spent at scene (difference between Paramedic scene departure and arrival at patient side)|immediately following evaluation|In order to be included in this analysis, a valid time for paramedic arrival and paramedic scene departure were required. Any patient refusing transport or missing time information was not included in the analysis.|||Minutes||Full Range|Mean
1409163|NCT01188447|Secondary|Performance of the Canadian C-Spine Rule|"Measurements of the performance of the rule will include:~rule accuracy~paramedic accuracy of interpretation~paramedic agreement and level of comfort with the decision suggested by the Canadian C-Spine Rule"|Rule accuracy will be within 30 days of enrollment. Paramedic accuracy of interpretation and agreement will be assessed immediately following enrollment.||||percentage of injuries identified||95% Confidence Interval|Number
1409164|NCT01188447|Secondary|Clearance Rate|Proportion of eligible low-risk patients transported without immobilization|Measures of clinical impact will be assessed immediately following the patient's Emergency Department visit||||Participants|||Count of Participants
1409165|NCT01188447|Primary|Adverse Events|"Measures of safety will include:~number of missed cervical spine injuries~number of serious adverse outcomes"|within 30 days of enrollment||||Adverse event|||Number
1409166|NCT01188421|Primary|Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.|Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal.|14 days total|Repeated measures ANOVA|||units on a scale||Standard Error|Mean
1409167|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of MMR Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.|||Participants|||Number
1409168|NCT01188343|Other Pre-specified|Serological Status of Flavivirus at Before (Baseline) Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|Neutralizing antibodies levels against dengue were only evaluated on subjects ELISA positive for Immunoglobulin G (IgG) or Immunoglobulin M (IgM). Flavivirus positive was defined as antibodies against JE-CV virus ≥10 (l/dil) or antibodies against at least one dengue virus serotype ≥10 (l/dil); Flavivirus negative was defined as antibodies against JE CV virus < 10 (l/dil) and antibodies against the 4 dengue virus serotypes < 10 (l/dil).|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Full Analysis Set.|||Participants|||Number
1409169|NCT01188343|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Administration of JE-CV Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling - ≥5 cm. Grade 3 systemic reactions: Fever - >39.5°C; Vomiting - ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - Sleeping most of the time or difficult to wake; Appetite Lost - Refused ≥3 feeds/meals or refused most feeds/meals; Irritability - Inconsolable.|Day 0 up to Day14 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated participants, the Safety Analysis Set.|||Participants|||Number
1409170|NCT01188343|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and After Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA).|Pre-vaccination and Day 42 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set population with evaluable data.|||Titers||95% Confidence Interval|Geometric Mean
1409171|NCT01188343|Secondary|Number of Participants With Seroprotection to JE-CV and MMR Antigens Before, at Month 6 After Last Vaccination and Month 12 After First Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroprotection was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 (1/dil) and post-vaccination titer ≥1/10, (1/dil) or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 units/ml when pre-vaccination titer is <10 units/ml; and for Rubella, post-vaccination titer ≥1/10 IU/ml when pre-vaccination titer is <10 IU/m|Pre-vaccination and up to Month 12 post-vaccination|Seroprotection to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated and who performed all protocol defined activities the Full Analysis Set.|||Participants|||Number
1410391|NCT01178268|Secondary|Acute Gain||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
1409172|NCT01188343|Secondary|Percentage of Participants With Seroconversion to JE-CV and MMR Antigens Before and 42 Days Following Concomitant Administration of JE-CV and MMR or Single Administration of JE-CV and MMR Vaccine|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/m|Pre-vaccination and Day 42 post-vaccination|Seroconversion to JE-CV and to MMR vaccine antigen was assessed in all participants who were randomized, vaccinated, who performed all protocol defined activities and has evaluable data (Per-protocol Analysis Set).|||Percentage of Participants|||Number
1409173|NCT01188343|Primary|Percentage of Participants With Seroconversion to Vaccine Antigens Following Concomitant Administration of Japanese Encephalitis Chimeric Virus Vaccine (JECV) and MMR or Single Administration of JE-CV and MMR Vaccine at 42 Days Following First Vaccination|JE-CV antigens were measured using a 50% plaque reduction neutralization test (PRNT50); MMR antigens were measured using enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as: for JE-CV - participants with a pre-vaccination titer <1/10 and post-vaccination titer ≥1/10, or a pre-vaccination titer ≥1/10 and 4-fold increase from pre- to post; for Measles - post-vaccination titer ≥120 mIU/ml, when pre-vaccination titer is <120 mIU/ml; for Mumps - post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml; and for Rubella, post-vaccination titer ≥1/10 U/ml when pre-vaccination titer is <10 U/ml.|Day 0 (pre-vaccination) and Day 42 post-vaccination|Seroconversion was assessed in the Per Protocol Analysis Set with evaluable data.|||Percentage of Participants|||Number
1409174|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409175|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409176|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409177|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|24 months after denture completion|For study participants who completed the 24-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409178|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|18 months after denture completion|For study participants who completed the 18-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409179|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|12 months after denture completion|For study participants who completed the 12-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409180|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|24 months after denture completion|For study participants who completed the 24-month follow-up.|||participants|||Number
1409181|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|18 months after denture completion|For study participants who completed the 18-month follow-up.|||participants|||Number
1409182|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels, high, little none)|12 months after denture completion|For study participants who completed the 12-month follow-up.|||participants|||Number
1409197|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count).|Baseline and 6 months||||polyps||Inter-Quartile Range|Median
1409183|NCT01188226|Secondary|Denture Teeth Calculus|Clinical evaluation of calculus for anterior teeth and posterior teeth on left and right sides on four-point scale (0= none; 1 = present on ≤ 1/3 of gingival margins; 2 = present on > 1/3 of gingival margins and parts of fissures and/or individual spots around cervical portion of tooth; 3 = covering more than ½ of gingival margins and the complete fissures and/or continuous heavy band of calculus around cervical portion of the tooth)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409184|NCT01188226|Secondary|Amount of Denture Teeth Plaque|Clinical evaluation of plaque for anterior teeth and left posterior teeth and right posterior teeth on four-point scale (0= none; 1 = soft debris covering ≤1/3 of tooth surface; 2 = soft debris covering > 1/3 and ≤ ½ of tooth surface; 3 = soft debris covering more than ½ of tooth surface)|6 months after denture completion|For study participants who completed the 6-month follow-up. Anterior, right-posterior, and left-posterior denture teeth areas of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409185|NCT01188226|Secondary|Denture Teeth Esthetics|Clinical evaluation of color deviation of anterior teeth to shade guide (3 levels: high, little, none)|6 months after denture completion||||participants|||Number
1409186|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|24 months after denture completion|For study participants who completed the 24-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 24-month lower-denture assessment|||participants|||Number
1409187|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|18 months after denture completion|For study participants who completed the 18-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.One participant had the lower denture refabricated after 12 months and was not included in 18-month lower-denture assessment|||participants|||Number
1409188|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal)|12 months after denture completion|For study participants who completed the 12-month follow-up. Upper and lower dentures assessed and reported separately as Arms for this outcome.|||participants|||Number
1409189|NCT01188226|Primary|Location of Posterior Denture Tooth Wear|Clinical evaluation of posterior wear location (right, left, equal).|6 months after denture completion|For study participants who completed the 6-month follow-up. Upper and lower dentures of each participant assessed and reported separately as Arms for this outcome.|||participants|||Number
1409190|NCT01188109|Secondary|Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression|To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1–10%; 2 = 11–50%; 3 = 51–100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: [(1+intensity score)/3]*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and > 2 was high ERCC1 expression.|At the time of resection|Twenty patients had tissue available for ERCC1 analysis.|||patients|||Number
1409191|NCT01188109|Primary|Recurrence-free Survival as Measured by CT Scan|Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.|Every 3 months and then every 6 months for 2 more years after resection||||months||95% Confidence Interval|Median
1409192|NCT01187953|Secondary|For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period (day 1 to day 734): death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|734 days|All 543 randomized patients were included in the analysis population.|||participants|||Number
1409193|NCT01187953|Primary|The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug.|Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.|360 days|All 543 randomized patients were included in the analysis population.|||participants|||Number
1409194|NCT01187914|Primary|Left Atrial (LA) Remodeling Pre-ablation|Utah staging for fibrosis (I - <=5%, II - 5.01%-20.0%, III - 20.01%-35% and IV - >=35.01%)|Once pre-ablation||||participants|||Number
1409195|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.|||polyps||Inter-Quartile Range|Median
1409196|NCT01187901|Secondary|Change in Number of Duodenal Polyps From Baseline to 6 Months in Classic FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in number of polyps in a 10-centimeter segment of the duodenum (6-month polyp count minus baseline polyp count)|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both|||polyps||Inter-Quartile Range|Median
1409198|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Attenuated FAP Participants|A comparison between the Sulindac-erlotinib and Placebo arm Attenuated FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Attenuated FAP participants are defined with the presence of a mutation in a portion of the adenomatous polyposis coli (APC) gene known to correlate with attenuated FAP and presentation of a milder phenotype in terms of polyp density in the participant and the family. All participants with attenuated FAP had a confirmed mutation in the APC gene.|||mm||Inter-Quartile Range|Median
1409199|NCT01187901|Secondary|Change in Duodenal Polyp Burden From Baseline to 6 Months in Classic Familial Adenomatous Polyposis (FAP) Participants|A comparison between the Sulindac-erlotinib and Placebo arm Classic FAP subgroups of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months|Classic FAP participants are defined as those presenting with more than 100 colonic adenomas and either (1) multiple family members with a classic FAP phenotype or (2) an adenomatous polyposis coli (APC) mutation in a region of the gene known to correlate with Classic FAP, or (3) both.|||mm||Inter-Quartile Range|Median
1409200|NCT01187901|Primary|Change in Duodenal Polyp Burden From Baseline to 6 Months|A comparison between the Sulindac-erlotinib and Placebo arms of the change in polyp burden from a 10-centimeter segment of the duodenum, measured as the sum of the diameters of the polyps, in millimeters (mm), from the duodenal segment (6-month polyp burden minus baseline polyp burden).|Baseline and 6 months||||mm||Inter-Quartile Range|Median
1409201|NCT01187771|Secondary|Mean 24-hour Diastolic Blood Pressure||9 months||||mmHg||Standard Deviation|Mean
1409202|NCT01187771|Secondary|Direct Health Care Costs||9 months|Data not collected.||||||
1409203|NCT01187771|Secondary|Depression (Patient Health Questionnaire-9)|The PHQ-9 is scored from 0-27 with higher scores indicating more severe depression.|9 months||||PHQ-9 scale||Standard Deviation|Mean
1409204|NCT01187771|Secondary|Calgary Sleep Apnea Quality of Life Index|The Calgary Sleep Apnea Quality of Life Index results in scores ranging from 1-7, with higher scores indicating a higher quality of life.|9 months||||Units on Quality of Life Index||Standard Deviation|Mean
1409205|NCT01187771|Secondary|Insulin Resistance (HOMA Index)||9 months|Data were not collected.||||||
1409206|NCT01187771|Secondary|Mean 24-hour Systolic Blood Pressure||9 months||||mmHg||Standard Deviation|Mean
1409207|NCT01187771|Primary|Epworth Sleepiness Score|The Epworth Sleepiness Scale results in scores ranging from 0-24, where scores of 0-10 indicate normal levels of sleepiness while 11-24 indicate excessive daytime sleepiness.|9 months||||Units on Epworth Sleepiness scale||Standard Deviation|Mean
1409208|NCT01187771|Primary|Effective Apnea Hypopnea Index|The Effective Apnea Hypopnea Index (AHI) is the actual frequency of apneas and hypopneas per hour that the patient is exposed to. It is calculated as the AHI while on CPAP times the proportion of sleep time that CPAP was used plus the AHI off CPAP times the proportion of sleep time that CPAP is not used.|9 months||||Events per hour||Standard Deviation|Mean
1409209|NCT01187550|Secondary|Change From Baseline in Lipid Profile at Week 4|Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||mmol/L||Standard Deviation|Mean
1409210|NCT01187550|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4|HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.|Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||pmol/L*mmol/L||Standard Deviation|Mean
1409211|NCT01187550|Secondary|Change From Baseline in Fasting Insulin at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||picomole/L (pmol/L)||Standard Deviation|Mean
1409212|NCT01187550|Secondary|Change From Baseline in Fasting Glucose at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure.|||millimole/liter (mmol/L)||Standard Deviation|Mean
1409213|NCT01187550|Secondary|Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4||Baseline and Week 4|ITT population set included all the participants who received at least 1 dose of study medication.|||microgram/mL (mcg/mL)||Standard Deviation|Mean
1409214|NCT01187550|Primary|Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4|Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.|Baseline and Week 4|The intent-to-treat (ITT) population set included all the participants who received at least 1 dose of study medication.|||nanogram/millilter (ng/mL)||Standard Deviation|Mean
1409215|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409270|NCT01187498|Secondary|Patient Satisfaction|"Patient global rating of satisfaction with progress in treatment (completely satisfied to very dissatisfied)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
1409216|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409217|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409218|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409219|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409220|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409221|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409222|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409223|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409224|NCT01187511|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409225|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409226|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409227|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409228|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409229|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409230|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409231|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409232|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409233|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409234|NCT01187511|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409235|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409271|NCT01187498|Secondary|Patient Global Perception of Improvement (GPI)|"Patient global perception of improvement (much better to much worse)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
1419603|NCT01102270|Secondary|Sleep Duration|total sleep duration|8 hour In-Laboratory Polysomnogram (PSG)||||hours of sleep||Standard Error|Mean
1409236|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 4 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409237|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 32 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409238|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409239|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 25 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409240|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409241|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 18 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409242|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409243|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 11 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409244|NCT01187511|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 32 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
1409272|NCT01187498|Secondary|Change on American Urological Association (AUA) Symptom Index|Change in score on American Urological Association (AUA) Symptom Index (baseline to week 8). The index measures lower urinary tract symptoms. Scores range from 0 to 35, with higher scores indicating worse symptoms.|baseline to post-treatment (week 8)|Completers|||Scores on the scale||Standard Deviation|Mean
1409245|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
1409246|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
1409247|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
1409248|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
1409249|NCT01187511|Secondary|Alcohol Craving in Response to the Trier/Cue-reactivity Procedure|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period|The analyses included only those subjects who completed the full Trier/cue-reactivity procedure|||Units on a scale||Standard Error|Least Squares Mean
1409250|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409251|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409252|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409253|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409254|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409255|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409273|NCT01187498|Secondary|Percent Change in Frequency of Urge Incontinence|Percent change in frequency of urge incontinence episodes based on 7-day bladder diary. Percent change was calculated as ([frequency at baseline] - [frequency at 8 weeks]) / (frequency at baseline).|baseline to post-treatment (week 8)|Included participants who experienced incontinence at baseline only|||Percent change in episodes per week||Standard Deviation|Mean
1409256|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409257|NCT01187511|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409258|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409259|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409260|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409261|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409262|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409263|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409264|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409265|NCT01187511|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
1409266|NCT01187498|Secondary|Patient Desire for Alternate Treatment|"Patient response to Do you wish to receive another form of treatment? (yes)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
1409267|NCT01187498|Secondary|Patient Global Rating of Bothersomeness of Side Effects|"Patient global rating of how bothersome their side effects were (no side effects to extremely bothersome)"|post-treatment (week 8)|Completers minus one missing value|||participants|||Number
1409268|NCT01187498|Secondary|Patient Report of Symptom Distress|"Patient report of how disturbed they were by symptoms (not at all to extremely)"|post-treatment (week 8)|Completers minos one missing value|||participants|||Number
1409269|NCT01187498|Secondary|Patient Global Rating of Activity Restriction|"Patient global rating of activity restriction (not at all to all the time)"|post-treatment (week 8)|Com0leters minus one missing value|||participants|||Number
1409274|NCT01187498|Secondary|Change in Urgency Severity|"Indevus Urgency Severity Scale incorporated into the 7-day bladder diary. Scores for urgency severity ranged from 0 to 3:~0: None—no urgency~Mild—awareness of urgency, but is easily tolerated.~Moderate—enough urgency discomfort that it interferes with or shortens usual activity~Severe—extreme urgency discomfort that abruptly stops all activities or tasks."|baseline to post-treatment (week 8)|Participants who completed treatment and returned bladder diary with useable urgency scores|||Score on scale||Standard Deviation|Mean
1409275|NCT01187498|Secondary|Change in Nocturia Frequency|Change in frequency of nocturia episodes based on 7-day bladder diary|baseline to post-treatment (week 8)||||nocturia episodes per night||Standard Deviation|Mean
1409276|NCT01187498|Primary|24-hour Voiding Frequency|Mean voiding frequency per 24 hours derived from 7-day bladder dairy|post-treatment (week 8)|Treatment completers|||voids per 24-hour day||Standard Deviation|Mean
1409277|NCT01187446|Secondary|Duration of Clinical Benefit (Supplemental Follow-up)|Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment or until progressive disease, as measured by the mSWAT skin assessment.|140 weeks|The data are reported for the full period for which participant data are available.|||weeks||Full Range|Median
1409278|NCT01187446|Secondary|Duration of Clinical Benefit (Per Protocol Follow-up)|Duration of clinical benefit represents the period of time that clinical response was maintained. Duration of clinical benefit is reported as the median period of time from the initiation of treatment until progressive disease, as measured by the mSWAT skin assessment, and censored at the final per-protocol assessment (48 weeks)|48 weeks after completion of treatment|The data are reported for the per-protocol period of follow-up (48 weeks).|||Weeks||Full Range|Median
1409279|NCT01187446|Secondary|Clinical Response Rate (CRR)|"Clinical Response Rate (CRR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0, consisting of complete response (CR) rate; partial response (PR) rate; stable disease (SD) rate; or progressive disease (PD) rate.~CR = 100% clearance of skin disease (mSWAT score = 0) PR = 50%to <100% clearance of skin disease as measured by > 50% decrease of mSWAT score compared with baseline SD = Not CR, PR, or PD~PD = Whichever is met first of:~> 25% increase in skin disease from baseline as measured by > 25% increase of mSWAT score compared with baseline~New tumor (T3) lesions in patients without prior T3 lesions (T1, T2, T4) or~In responders (confirmed), increase in skin disease over nadir by 50% of baseline as measured by mSWAT score of > [nadir + > 50% of baseline]~Relapse applies to any new disease after confirmed CR"|Week 8||||Participants|||Count of Participants
1409280|NCT01187446|Secondary|Safety and Tolerability as Measured by Severity and Frequency of Adverse Events|Adverse events occurring at least 10% out of evaluable participants, and it's corresponding rate in the opposing arm.|Adverse events were collected through 30 days after the last day of study therapy, or until the patient received an non-study treatment for lymphoma, whichever occurred first.||||Number of patients|||Number
1409281|NCT01187446|Primary|Complete Clinical Response (CCR)|Complete Clinical Response (CCR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0. mSWAT is an objective, quantitative, severity-weighted method to assess the extent of mycosis fungoides (MF) lesions, and is determined by total body surface area (%TBSA) of the lesion by a severity-weighting factor (1 = patch; 2 = plaque; 4 = tumor). O% TBSA produces a product of 0, indicating complete response.|Week 8||||Participants|||Count of Participants
1409282|NCT01187433|Primary|Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo|Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post each vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1409283|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1409284|NCT01187433|Primary|Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1409285|NCT01187433|Primary|Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titers were assessed in the Full Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1409286|NCT01187433|Primary|Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Geometric mean titer ratios were assessed in the Full Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1409326|NCT01187329|Primary|Myocardial Function: Left Ventricular Global Longitudinal Strain (%)|"Left ventricular global longitudinal strain measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values (%) mean a worse outcome."|end of surgery, closure||||percentage of myocardial shortening||Standard Deviation|Mean
1409287|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
1409288|NCT01187433|Primary|Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
1409289|NCT01187433|Primary|Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
1409290|NCT01187433|Primary|Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.|Before and 28 Days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
1409291|NCT01187433|Primary|Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
1409292|NCT01187433|Primary|Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo|Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).|Before and 28 days after each injection|Seropositivity was assessed in the Full Analysis Set.|||Percentage of participants|||Number
1409293|NCT01187407|Secondary|Pharmacokinetics: Plasma Concentrations of LY2216684|A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.|Pre-randomization, 1 week, 4 weeks, and 8 weeks|Participants exposed to LY2216684 with evaluable plasma concentration values. Samples with concentrations below the lower quantification limit (BQL) of the assay were treated as missing values for the analysis and samples with incomplete dosing information were not included in the pharmacokinetic assessment.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1409294|NCT01187407|Secondary|Change From Randomization to Week 8 in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1409295|NCT01187407|Secondary|Change From Randomization to Week 8 in Blood Pressure|Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1409296|NCT01187407|Secondary|Change From Randomization to Week 8 in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409327|NCT01187043|Primary|Induction Amenorrhea|Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.|10 weeks|Per protocol: subjects who exhibited trough levels of proellex on at least 7 of the 10 weekly visits during the dosing period|||participants|||Number
1409328|NCT01187017|Secondary|Secondary Endpoints Will Evaluated for the Study to Include: (a) Hematologic Response at 3 and 12 Months and Yearly Thereafter; (b) Relapse (c) Clonal Evolution to Paroxysmal Nocturnal Hemoglobinuria (PNH), Myelodysplasia or Acute Leukemia; (e) Survival.||12 months|||||||
1409297|NCT01187407|Secondary|Change From Randomization to Week 8 in the Arizona Sexual Experiences (ASEX) Scale|The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) of the 5 items of the ASEX scale. Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409298|NCT01187407|Secondary|Percentage of Participants With Treatment-emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Event module."|Randomization through 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
1409299|NCT01187407|Secondary|Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409300|NCT01187407|Secondary|Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a self-administered 16 item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of maximum possible score||Standard Error|Least Squares Mean
1409301|NCT01187407|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409302|NCT01187407|Secondary|Change From Randomization to Week 8 in The Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409303|NCT01187407|Secondary|Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)|CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409329|NCT01187017|Primary|Response Rate at 6 Months|The primary objective is to assess the Flu/Cy hematological response in SAA.The primary endpoint will be response at six months.|6 months||||participants|||Number
1409330|NCT01187004|Secondary|Intensive Care Unit (ICU) Length of Stay|If extracardiac complications, especially acute lung injury, prolonged Intensive Care Unit (ICU) length of stay due to longer mechanical ventilation.|at 28 days|The analysis of the Intensive Care Unit (ICU) length of stay was done on all the patients included in the study. We want to evaluate if the development of acute lung injury prolongs the intensive care unit length of stay.ICU length of stay was calculated up to 28 days,and patients who died before were considered as having the maximum value|||days||Inter-Quartile Range|Median
1409304|NCT01187407|Secondary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409305|NCT01187407|Secondary|Change From Randomization to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409306|NCT01187407|Secondary|Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8|A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value. Last observation carried forward (LOCF) methodology was used.|||percentage of participants|||Number
1409307|NCT01187407|Secondary|Change From Randomization to Week 8 in the Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8 to 10 represent 'borderline' and scores of 0 to 7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409308|NCT01187407|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement|A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
1409309|NCT01187407|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 up to Week 8|A MADRS total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value. Last observation carried forward (LOCF) methodology was used.|||percentage of participants|||Number
1409310|NCT01187407|Secondary|Change From Randomization to Week 8 in the Fatigue Associated With Depression (FAsD) Impact Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409311|NCT01187407|Secondary|Change From Randomization to Week 8 in the Sheehan Disability Scale (SDS) Global Functional Impairment Score|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409312|NCT01187407|Primary|Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409313|NCT01187381|Secondary|Percentage of Participants by the Site of First Disease Progression||Baseline up to 5 years|Number of participants analyzed=participants who presented disease progression|||percentage of participants|||Number
1409314|NCT01187381|Secondary|Progression Free Survival|Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician. Due to observational nature of the study, there was no specific method of assessment used to define progressive disease. Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.|Baseline uo tp 5 years|Number of participants analyzed=participants who presented progression of disease|||days||Full Range|Median
1409315|NCT01187381|Secondary|Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer||Baseline up to 5 years|All enrolled participants|||percentage of participants|||Number
1409316|NCT01187381|Secondary|Percentage of Participants Who Had Surgical Procedure for Breast Cancer|Percentage of participants who underwent different types of surgical procedures for breast cancer are reported. Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).|Baseline up to 5 years|Number of participants analyzed=participants who were evaluable for this outcome measure|||percentage of participants|||Number
1409317|NCT01187381|Secondary|Percentage of Participants Who Received Previous Neoadjuvant Therapy|As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies. Percentage of participants who received these therapies is reported.|Baseline up to 5 years|Number of participants analyzed=participant with data available for this outcome|||percentage of participants|||Number
1409318|NCT01187381|Secondary|Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation||Baseline up to 5 years|All enrolled participants|||percentage of participants|||Number
1409319|NCT01187381|Primary|Treatment Duration With Trastuzumab in the Routine Clinical Practice||Baseline up to 5 years|Number of participant analyzed=participants with data available for this outcome measure.|||Days||Standard Deviation|Mean
1409320|NCT01187355|Secondary|Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.|||Units on a scale||Standard Deviation|Mean
1409321|NCT01187355|Secondary|Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.|||Units on a scale||Standard Deviation|Mean
1409322|NCT01187355|Primary|Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.|As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.|Day 30|All enrolled and dispensed subjects with an on-regimen follow-up visit.|||Units on a scale||Standard Deviation|Mean
1409323|NCT01187329|Secondary|Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate|"Right ventricular global longitudinal strain rate measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values mean a worse outcome"|end of surgery, closure||||Percent / sec||Standard Deviation|Mean
1409324|NCT01187329|Secondary|Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain|"Right ventricular global longitudinal strain measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values mean a worse outcome."|end of surgery, closure.||||percentage of myocardial shortening||Standard Deviation|Mean
1409325|NCT01187329|Primary|Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate|"Left ventricular global longitudinal strain rate measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography.~higher values mean a worse outcome"|end of surgery, closure||||Percent / sec||Standard Deviation|Mean
1423326|NCT01070784|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
1409331|NCT01187004|Primary|Acute Lung Injury After Cardiac Surgery|to evaluate the incidence of acute lung injury (ALI) in patients undergoing cardiac surgery with cardiopulmonary by pass and to identify the main predictors.Diagnosis of Acute Lung Injury (ALI) was made according to the American-European Consensus conference criteria, including acute onset, PaO2 /FiO2 <300 regardless of Positive End Expiratory Pressure (PEEP) level, bilateral and diffuse opacities on chest radiograph, absence of left ventricular failure, or history of lung disease.|at seven days after intervention|Patients consecutively admitted to the cardiac Intensive Care Unit (cICU) after cardiac surgery on cardiopulmonary by pass (CPB), during a time frame of two years.The analysis was per protocol, to identify the predictors of acute lung injury after cardiac surgery.|||participants|||Number
1409332|NCT01186939|Primary|Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period|Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption.|43- 68 months|Safety population includes all 40 participants in the extension study.|||participants|||Number
1409333|NCT01186848|Primary|Live-rater by Two Blinded Dermatologists|"The primary outcome was a blinded rating of the treatment area (Fractional Laser vs. Fractional Laser plus Intense Focused Ultrasound) with the best cosmetic appearance. Two dermatologists blindly evaluated the treated and control areas of each side from live subjects on the final follow up visit (week 10). This was reported as percentages of participants for whom 1550-nm Erbium-doped Fractionated Laser or Micro-focused Ultrasound and 1550nm-fractionated Laser resulted in the best cosmetic appearance."|week 10||||Percentage of participants||95% Confidence Interval|Number
1409334|NCT01186796|Secondary|Mean GH Half-Life in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||min||Standard Error|Mean
1409335|NCT01186796|Secondary|Mean Duration of GH Bursts (Mode) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||min||Standard Error|Mean
1409336|NCT01186796|Secondary|Mean Mass of GH Released Per Burst in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated on each 6-hr pool of data by utilizing a previously published deconvolution method and analyzed via two-way ANOVA.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||ug/L||Standard Error|Mean
1409337|NCT01186796|Secondary|Mean GH Concentration (Pulsatile) in Response to Secretagogue|Subjects were administered 4 different secretagogues: (i) L-arginine/Saline, (ii) L-arginine/Ghrelin, (iii) L-arginine/GHRH, and (iv) L-arginine / GHRH + Ghrelin. The result was calculated by averaging values over the 6 hour collection timeframe.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||ug/L/6h||Standard Error|Mean
1409338|NCT01186796|Primary|Mean Baseline GH Concentration|Averaged over 90-min baseline on the saline day.|Withdrawal of blood samples (2.5 mL each) every 10 min for 6 hr. Sampling will begin at 0800 h and conclude at 1400 h.||||ug/L||Standard Error|Mean
1409339|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)||Weeks 4, 8, and 16 (Period C)|Safety-C|||percentage of participants|||Number
1409340|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)||Weeks 4, 8, 12, and 16 (Period B)|Safety-B|||percentage of participants|||Number
1409341|NCT01186744|Secondary|Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)||Weeks 4, 8, 16, and 24 (Period A)|Safety-A|||percentage of participants|||Number
1409342|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
1409343|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation|||scores on a scale||Standard Error|Mean
1409344|NCT01186744|Secondary|Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1413466|NCT01153620|Secondary|Comparison of the Percentage of Patients With Target Wounds <50 CFU|Comparison of the percentage of patients with target wounds <50 CFU after 60 minutes of treatment application|60 minutes|||||||
1409345|NCT01186744|Secondary|Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed)."|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation.|||score on a scale||Standard Error|Mean
1409346|NCT01186744|Secondary|Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-C defined as the last observation up to first dosing date in Period C."|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
1409347|NCT01186744|Secondary|Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-A defined as the last observation up to first dosing date in Period A."|Week 24 (Period A)|FAS-A; n=number of participants with an observation|||scores on a scale||Standard Error|Mean
1409348|NCT01186744|Secondary|Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1409349|NCT01186744|Secondary|Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n=number of participants with an observation.|||score on a scale||Standard Error|Mean
1409350|NCT01186744|Secondary|Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
1409351|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
1409352|NCT01186744|Secondary|Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
1409353|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants|||Number
1409354|NCT01186744|Secondary|Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percentage of participants|||Number
1409355|NCT01186744|Secondary|Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe|Baseline and Weeks 4, 8, 16 and 24 (Period A)|FAS-A|||percentage of participants|||Number
1409356|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-C defined as the last observation up to first dosing date in Period C.|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
1409357|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-A defined as the last observation up to first dosing date in Period A.|Week 24 (Period A)|FAS-A; n=number of participants with an observation|||scores on a scale||Standard Error|Mean
1409358|NCT01186744|Secondary|Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1409359|NCT01186744|Secondary|Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation|||score on a scale||Standard Error|Mean
1409360|NCT01186744|Secondary|Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 56 (Period C)|FAS-C|||scores on a scale||Standard Error|Mean
1409361|NCT01186744|Secondary|Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Week 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
1409362|NCT01186744|Secondary|Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 56 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1409480|NCT01186419|Secondary|Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|92 weeks|PK Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.|||ng*hr/ml||Standard Deviation|Mean
1409363|NCT01186744|Secondary|Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A)|The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and standard deviations (SDs) of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life.|Baseline and Week 24 (Period A)|FAS-A; n=number of participants with an observation|||score on a scale||Standard Error|Mean
1409364|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.|||weeks||95% Confidence Interval|Median
1409365|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
1409366|NCT01186744|Secondary|Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||weeks||95% Confidence Interval|Median
1409367|NCT01186744|Secondary|Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
1409368|NCT01186744|Secondary|Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants|||Number
1409369|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C DLQI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
1409370|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI >1 where Baseline-B defined as last observation up to first dosing date in Period B.|||percentage of participants|||Number
1409371|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≤1, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
1409372|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C DLQI ≥5|||percentage of participants||95% Confidence Interval|Number
1409373|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B participants with Baseline-B DLQI ≥5.|||percentage of participants|||Number
1409374|NCT01186744|Secondary|Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A DLQI ≥5, where Baseline-A is defined as the last observation up to first dosing date in Period A. n=participants with an observation.|||percentage of participants||95% Confidence Interval|Number
1409375|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||scores on a scale||Standard Error|Mean
1409376|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||scores on a scale||Standard Error|Mean
1409377|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
1409378|NCT01186744|Secondary|Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1409389|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||weeks||95% Confidence Interval|Median
1409379|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
1409380|NCT01186744|Secondary|Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3).|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
1409381|NCT01186744|Secondary|Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||scores on a scale||Standard Error|Mean
1409382|NCT01186744|Secondary|Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||scores on a scale||Standard Error|Mean
1409383|NCT01186744|Secondary|Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
1409384|NCT01186744|Secondary|Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
1409385|NCT01186744|Secondary|Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1409386|NCT01186744|Secondary|Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)|The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
1409387|NCT01186744|Secondary|Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.|||weeks||95% Confidence Interval|Median
1409388|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI ≥2, where Baseline-C defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
1409390|NCT01186744|Secondary|ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
1409391|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C.|||weeks||95% Confidence Interval|Median
1409392|NCT01186744|Secondary|ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
1409393|NCT01186744|Secondary|Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||weeks||95% Confidence Interval|Median
1409394|NCT01186744|Secondary|ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
1409395|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI ≥2, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
1409396|NCT01186744|Secondary|Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI ≥2, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
1409397|NCT01186744|Secondary|Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
1409398|NCT01186744|Secondary|Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI >1, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
1409399|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C participants with a Baseline-C ISI greater than (>) 0, where Baseline-C is defined as the last observation up to first dosing date in Period C.|||percentage of participants||95% Confidence Interval|Number
1409450|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
1423327|NCT01070784|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and 52 week after||||ms||Standard Deviation|Mean
1409400|NCT01186744|Secondary|Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A participants with a Baseline-A ISI greater than (>) 0, where Baseline-A is defined as the last observation up to first dosing date in Period A.|||percentage of participants||95% Confidence Interval|Number
1409401|NCT01186744|Secondary|Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-C defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
1409402|NCT01186744|Secondary|Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-B defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
1409403|NCT01186744|Secondary|Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends. Baseline-A defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
1409404|NCT01186744|Secondary|Mean ISI Score During the CP-690,550 Re-Treatment (Period C)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1409405|NCT01186744|Secondary|Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
1409406|NCT01186744|Secondary|Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)|The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate “your worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “No itching” (0) and “Worst possible itching” (10) at the ends.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
1409407|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
1409408|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percentage of participants|||Number
1409409|NCT01186744|Secondary|Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)|PASI quantifies the severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
1409451|NCT01186744|Secondary|Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)||Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||weeks||95% Confidence Interval|Median
1410299|NCT01178944|Secondary|Time to Progression (TTP)|Estimated using the Kaplan-Meier method and proportional hazards models.|From the date of study enrollment to the first observation of progressive disease, assessed up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1409410|NCT01186744|Secondary|Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
1409411|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
1409412|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C)|PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percentage of participants||95% Confidence Interval|Number
1409413|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
1409414|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
1409415|NCT01186744|Secondary|Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A|PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; NRI|||percentage of participants||95% Confidence Interval|Number
1409416|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
1409417|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
1409452|NCT01186744|Secondary|Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)|Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.|Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
1409418|NCT01186744|Secondary|Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
1409419|NCT01186744|Secondary|Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
1409420|NCT01186744|Secondary|Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
1409421|NCT01186744|Secondary|Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||score on a scale||Standard Error|Mean
1409422|NCT01186744|Secondary|Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-C defined as last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||scores on a scale||Standard Error|Mean
1409423|NCT01186744|Secondary|Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-B defined as last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||scores on a scale||Standard Error|Mean
1409424|NCT01186744|Secondary|Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||scores on a scale||Standard Error|Mean
1409479|NCT01186458|Primary|Overall Response Rate|To determine the overall response rate and frequency of complete and partial responses in patients with relapsed or refractory follicular non-Hodgkin lymphoma (NHL) who receive therapy with fludarabine, Velcade, and rituximab administered every 28 days.|6 months|Data for this primary objective was not collected or analyzed due to the termination of the study.||||||
1410392|NCT01178268|Secondary|Percent Diameter Stenosis (%DS)||post procedure on 0 day|The number of participants with angiographic follow up available was analysed.|||Percent Diameter stenosis|Participants|Standard Deviation|Mean
1409425|NCT01186744|Secondary|Mean PASI Score During the CP-690,550 Re-Treatment (Period C)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||score on a scale||Standard Error|Mean
1409426|NCT01186744|Secondary|Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||score on a scale||Standard Error|Mean
1409427|NCT01186744|Secondary|Mean PASI Score During Initial CP-690,550 Treatment (Period A)|Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||score on a scale||Standard Error|Mean
1409428|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Baseline defined as the last observation up to first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
1409429|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent psoriatic BSA||Standard Error|Mean
1409430|NCT01186744|Secondary|Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||percent change in psoriatic BSA||Standard Error|Mean
1409431|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
1409432|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent psoriatic BSA||Standard Error|Mean
1409433|NCT01186744|Secondary|Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
1409434|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Baseline was defined as the last observation until first dosing date in Period C.|Weeks 4, 8, and 16 (Period C)|FAS-C; n equals number of participants with an observation|||percent change in psoriatic BSA||Standard Error|Mean
1409435|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Baseline defined as the last observation up to first dosing date in Period B.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent change in psoriatic BSA||Standard Error|Mean
1409436|NCT01186744|Secondary|Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)|Baseline defined as the last observation up to first dosing date in Period A.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals number of participants with an observation|||percent change in psoriatic BSA||Standard Error|Mean
1409437|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C; n equals the number of participants with an observation|||percent psoriatic BSA||Standard Error|Mean
1409438|NCT01186744|Secondary|Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 12, and 16 (Period B)|FAS-B; n equals the number of participants with observations|||percent psoriatic BSA||Standard Error|Mean
1409439|NCT01186744|Secondary|Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)|Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.|Baseline and Weeks 4, 8, 16, and 24 (Period A)|FAS-A; n equals the number of participants with an observation.|||percent psoriatic BSA||Standard Error|Mean
1409440|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
1409441|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants|||Number
1409442|NCT01186744|Secondary|Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)|PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
1409443|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
1409444|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants|||Number
1409445|NCT01186744|Secondary|Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
1409446|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C||Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||weeks||95% Confidence Interval|Median
1409447|NCT01186744|Secondary|Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||weeks||95% Confidence Interval|Median
1409448|NCT01186744|Secondary|Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
1409449|NCT01186744|Secondary|Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C|PASI75 response defined as at least a 75% reduction in PASI relative to baseline.|Weeks 4, 8, and 16 (Period C)|FAS-C|||weeks||95% Confidence Interval|Median
1409453|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 16 of Period B.|||percentage of participants|||Number
1409454|NCT01186744|Secondary|Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)|The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.|Weeks 4 and 8 (Period B)|FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 8 of Period B.|||percentage of participants||95% Confidence Interval|Number
1409455|NCT01186744|Secondary|Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||weeks||95% Confidence Interval|Median
1409456|NCT01186744|Secondary|Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)|Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
1409457|NCT01186744|Secondary|Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)|PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||percentage of participants||95% Confidence Interval|Number
1409458|NCT01186744|Secondary|Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 16, and 24 (Period A)|FAS-A|||weeks||95% Confidence Interval|Median
1409459|NCT01186744|Secondary|Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.|Weeks 4, 8, 16, and 24 (Period A)|The Period A-Full Analysis Set (FAS-A) included all participants who were randomized at baseline and received at least 1 dose of the randomized investigational drug (CP-690,550 5mg BID or 10 mg BID) during Period A.|||weeks||95% Confidence Interval|Median
1409460|NCT01186744|Primary|Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Baseline and Weeks 4, 8, and 16 (Period C)|The Period C-Full Analysis Set (FAS-C) included all FAS-B participants who were advanced to the re-treatment period (Period C) during the 16 weeks of Period B and had received at least one dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period C.|||percentage of participants||95% Confidence Interval|Number
1409461|NCT01186744|Primary|Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.|Baseline and Weeks 4, 8, and 16 (Period C)|FAS-C|||percentage of participants||95% Confidence Interval|Number
1409462|NCT01186744|Primary|Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).|Weeks 4, 8, 12, and 16 (Period B)|FAS-B|||percentage of participants||95% Confidence Interval|Number
1409463|NCT01186744|Primary|Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.|Weeks 4, 8 12, and 16 (Period B)|The Period B-Full Analysis Set (FAS-B) included all participants who were re-randomized at the end of Period A and received at least 1dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) or placebo at the beginning of Period B.|||percentage of participants||95% Confidence Interval|Number
1409464|NCT01186705|Primary|Overall Objective Response Rate (ORR)|in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)|1 year||||participants|||Number
1409465|NCT01186692|Secondary|Changes in NYHA Functional Classification|Change in NYHA functional class from pre-implant to 6 month post-implant|6 Months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable paired NYHA data were included in the analysis.|||participants|||Number
1409466|NCT01186692|Secondary|Serious Device-related Adverse Events|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|6 months|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.|||percentage of patients|||Number
1409467|NCT01186692|Secondary|Serious Procedural Adverse Events|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|6 Months|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of patients|||Number
1409468|NCT01186692|Secondary|Procedural Success|"Procedural success is defined as a composite of the following:~The TPV is fixated within the desired location, and~The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and~There is no more than trivial pulmonary regurgitation by angiography~The subject is free from explantation of the TPV at 24 hours post-implant"|6 Months|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).|||percentage of patients|||Number
1409469|NCT01186692|Primary|Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation|"Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:~Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and~Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and~Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation.~The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation."|6 months|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable echo data at 6 months post implant were included in the analysis.|||percentage of patients||95% Confidence Interval|Number
1409470|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)|18 months|This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.|||min*ng/dL||Standard Error|Mean
1409471|NCT01186562|Secondary|Acute C-peptide Response (ACR) to Glucose|Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)|12 months|This test required two IVs. In patients for whom 2 IVs could not be placed successfully, this test could not be performed. N's reflect number of patients completing this test.|||min*ng/dL||Standard Error|Mean
1409472|NCT01186562|Secondary|AUC C-peptide|AUC C-peptide (ng/dL*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)|18 months|Patients with vomiting, NPO (Nothing by Mouth) restrictions (due to chronic GI illness) were not able to complete MMTT. (Mixed meal Tolerance Test) The N for each group reflects the number of patients who successfully completed this assessment.|||min*ng/dL||Standard Deviation|Mean
1409473|NCT01186562|Secondary|Area Under the Curve (AUC) C-peptide (ng/dL*Min)|AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)|12 months|Patients with vomiting, NPO restrictions (due to chronic GI illness) were not able to complete MMTT. The N for each group reflects the number of patients who successfully completed this assessment.|||ng*min/dL||Standard Error|Mean
1409474|NCT01186562|Secondary|Insulin Independence|percentage of patients insulin independent|18 months||||percentage of participants|||Number
1409475|NCT01186562|Primary|Insulin Independence|percentage of patients insulin independent|12 months|N's reflect patients that returned for study follow up.|||percentage of participants|||Number
1409476|NCT01186458|Secondary|Biologic Interaction|To explore the biologic interaction between fludarabine and Velcade and determine if Velcade can potentiate the DNA-damaging effect of fludarabine.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.||||||
1409477|NCT01186458|Secondary|Toxicity|To evaluate the toxicity profile of this regimen. Adverse event counts by grade are presented.|6 months||||number of adverse events|||Number
1409478|NCT01186458|Secondary|Survival|To evaluate the progression-free survival and event-free survival in patients who receive therapy with fludarabine, Velcade, and rituximab.|6 months|Data for this secondary objective was not collected or analyzed due to the termination of the study.||||||
1409481|NCT01186419|Secondary|Maximum Plasma Concentration (Cmax) of SPD602|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|92 weeks|Pharmacokinetic (PK) Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product.|||ng/ml||Standard Deviation|Mean
1409482|NCT01186419|Primary|Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks|LIC was determined by R2 Magnetic Resonance Imaging (MRI).|Baseline and 96 weeks|Full Analysis Set, defined as all subjects in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all subjects who received any amount of investigational product.|||mg/g||Standard Deviation|Mean
1409483|NCT01186406|Secondary|Unacceptable Toxicity Related to the Treatment Regimen|The number of patients experiencing unacceptable toxicity defined as the occurrence of ≥ grade 2 CNS hemorrhage or treatment-related grade 4 or 5 non-hematologic toxicity.|27 months||||Participants|||Count of Participants
1409484|NCT01186406|Secondary|Median Progression-free Survival|Progression-free survival was defined as the time in months from the date study treatment started until the date of progression or the date of death if death occurred before progression, or until the date of last follow-up if alive without progression. Kaplan-Meier methods were used to estimate progression-free survival.|21 months|Intent-to-treat|||months||95% Confidence Interval|Median
1409485|NCT01186406|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat|||months||95% Confidence Interval|Median
1409486|NCT01186406|Primary|21-month Overall Survival|The percentage of participants alive at 21 months after the start of study treatment. Overall survival was calculated from the date study treatment started until the date of death or the date of last follow-up if alive. Kaplan-Meier methods were used to estimate overall survival.|21 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1409487|NCT01186250|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year|measure of low levels of C-reactive protein to identify low but persistent levels of inflammation|Baseline and 1 year|participant drop put|||mg/L||Standard Deviation|Mean
1409488|NCT01186250|Secondary|Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.|Competitive ELISA assay in Stanford laboratory.|Baseline and 1 year|One participant in one arm did not have Baseline or one year data.|||umol/L||Standard Deviation|Mean
1409489|NCT01186250|Secondary|Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)|The change in maximal intimal thickness (MIT) from baseline to one year was recorded for several matched sites in the same coronary artery, the cross sections, predominantly in the left anterior descending coronary artery, from baseline to one-year follow-up, were studied. The IVUS cross sections were matched by using identifiable landmarks in the images, such as bifurcations or arterial calcification, or external landmarks, such as coronary veins or pericardium. In addition, the one-year IVUS studies were obtained with an angiographic roadmap of where the initial IVUS study was performed along the length of the vessel. The IVUS system auto pullback was performed at .5 mm/s from the mid-distal portion of the study vessel, where an easily identifiable landmark was visible (i.e., branchpoint). The following items were measured for each patient: maximal intimal thickness (MIT), intimal area (IA), and vessel area.|Baseline and 1 year|number participants analyzed contained drops out due to clinical reasons|||mm||Standard Deviation|Mean
1409490|NCT01186250|Secondary|Change From Baseline in TG/HDL Ratio at One Year|Triglyceride ratio to High Density Lipoprotien|Baseline and 1 year|One drop out|||ratio||Standard Deviation|Mean
1409491|NCT01186250|Secondary|Change in Levels of Fasting Glucose at Baseline and 1 Year|Oral Glucose Tolerance Test : blood was drawn for fasting plasma glucose and insulin levels, followed by ingestion of a solution containing 75grams of glucose. Repeat blood samples were collected for glucose and insulin levels at 30, 90, and 120 minutes after glucose ingestion. All glucose measurements were performed by the Clinical Translational Research Unit (CTRU) Stanford University.|Baseline and 1 year|One participant in each group did not complete the OGTT.|||mg/dL||Standard Deviation|Mean
1409492|NCT01186250|Secondary|Change in Intimal Volume|Intimal volume is defined as external elastic membrane volume minus lumen (luminal) volume measured at the heart Catheterization and intravascular Ultrasound( IVUS)|baseline and 1 year|The number of participants enrolled were not all included in the intimal volume analysis because the Angiographic diagnostic evaluation needed for intimal volume measurement was clinically inappropriate for 3 in the pioglitazone arm and 5 in the Placebo arm at 12 months post transplant.|||mm^3||Standard Deviation|Mean
1409493|NCT01186250|Primary|Insulin Levels Area Under Curve(AUC)|Change from baseline in Insulin Levels During Oral Glucose Tolerance test at 1 year.|Baseline and 1 year||||h*pmol/L||95% Confidence Interval|Mean
1409494|NCT01185964|Secondary|Percentage of Participants With Anti-Olaratumab Antibody Assessment|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline, Up to 30 Months|All participants who had baseline and post baseline anti-olaratumab antibodies.|||percentage of participants|||Number
1409495|NCT01185964|Secondary|PK: Half-Life (T1/2) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab||Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||Days||Full Range|Geometric Mean
1409496|NCT01185964|Secondary|PK: Area Under Concentration Curve Versus Time (AUCτ) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab|AUCτ = area under the concentration versus time curve during one dosing interval with a measurable concentration.|Cycle 1 Day 8:Preinfusion,1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr,24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||microgram•hour/milliliter (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
1410393|NCT01178268|Secondary|Percent Diameter Stenosis||pre procedure|The number of participants with angiographic follow up available was analysed.|||percent Diameter stenosis|Participants|Standard Deviation|Mean
1409497|NCT01185964|Secondary|PK: Minimum Concentration (Cmin) Cycle 1 Day 8, Cycle 3 Day 8 of Olaratumab||Cycle 1 Day 8: Preinfusion, 1hr,72hr,168hr Post Infusion; Cycle 3 Day 8: Preinfusion,1hr, 24hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1409498|NCT01185964|Secondary|Pharmacokinetic (PK) Maximum Concentration (Cmax) Cycle 1 Day 1, Cycle 3 Day 1 of Olaratumab||Cycle 1 Day 1: Preinfusion, End of Infusion,1hr,48hr,72hr,168 hr Post infusion; Cycle 3 Day 1:Preinfusion, End of Infusion,1hr,24hr,48hr,72hr,168hr Post Infusion|All participants who had evaluable PK data in Phase 1b and Phase 2. Per protocol, optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure.|||nanogram/milliliter (μg/mL )||Geometric Coefficient of Variation|Geometric Mean
1409499|NCT01185964|Secondary|Percentage of Participants Who Are Progression-Free (PFS) at 3 Months|(PFS) rate is defined as the percentage of participants that are alive and progression-free 3 months after randomization. PFS is measured from randomization until the first radiographic progressive disease as defined by RECIST (version 1.1) or death from any cause. Participants who died without PD were considered to have progressed on the day of death. Censoring applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization or the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit. If participant started new treatment before PD, participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.|Randomization Until First Radiographic PD or Death from Any Cause (Up to 3 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.|||percentage of participants||95% Confidence Interval|Number
1409500|NCT01185964|Secondary|Percentage of Participants With Objective Response (Objective Response Rate)|Objective Response Rate (ORR) is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.|Randomization Until Progressive Disease (Up to 30 Months)|All randomized participants in Phase 2 and optional Olaratumab monotherapy.|||percentage of participants||95% Confidence Interval|Number
1409501|NCT01185964|Secondary|Overall Survival (OS)|OS was defined as the date of randomization to the date of death from any cause. Reasons for censoring OS were that participant was known to be alive, participant was lost to follow up during the study or participant withdrew consent to follow up.|Randomization to the Date of Death From Any Cause (Up To 47 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored participants = Phase 2 Olaratumab + Doxorubicin = 27 and Doxorubicin = 15.|||Months||95% Confidence Interval|Median
1409502|NCT01185964|Secondary|Number of Participants With AEs and SAEs for Phase 2 Portion|A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline, Up to 30 Months|All randomized participants who received at least 1 dose of study drug in Phase 2 and optional Olaratumab monotherapy.|||participants|||Number
1409503|NCT01185964|Primary|Number of Participants With Treatment Related Adverse Events (TEAE), Adverse Events (AE) or Serious Adverse Events (SAE) for Safety for the Phase 1b Portion of the Study|All Phase 1b participants who experienced at least 1 TEAE in the Phase 1b portion of the study. Adverse Event with missing relationship to study is counted as related. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline Up to 30 Months|All participants in Phase 1b.|||participants|||Number
1409504|NCT01185964|Primary|Progression-free Survival (PFS)|PFS is measured from randomization until the first radiographic documentation of progression of disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) or death from any cause. Participants who died without PD was considered to have progressed on the day of death. The following censoring rules applied: If no radiologic assessment at baseline or post baseline, participant was censored at the date of randomization. Participants were censored at the day of their last tumor assessment if no PD and were lost to follow up; If death or PD occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last adequate radiographic visit. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.|Randomization Until the First Radiographic Documentation of Objective Progression (Up to 29 Months)|All randomized participants in Phase 2. Per protocol, phase 1b and optional Olaratumab monotherapy data was exploratory and not collected for this outcome measure. Censored Participants = Phase 2 Olaratumab + Doxorubicin = 11 and Doxorubicin = 19.|||Month||95% Confidence Interval|Median
1409505|NCT01185834|Secondary|Overall Lens Fit|As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale|Participants|Standard Deviation|Mean
1409506|NCT01185834|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|3 months of wear, replacing lenses monthly|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
1409507|NCT01185821|Secondary|Percentage of Participants Free of Confirmed Disability Progression in Extension Study (Extension Set)|Six-month disability progression was defined relative to extension baseline EDSS score: 1.5 point increase in patients with baseline EDSS score of 0, 1.0 increase in patients with baseline EDSS score of between 0.5 to 5.0, inclusive and 0.5 increase in patients with baseline EDSS score of ≥ 5.5. The criteria for 6-month disability progression included detection of onset of progression and confirmation of progression for a period of at least 6 months.|Baseline Extension up to approximately 5 years||||percentage of participants||95% Confidence Interval|Number
1409508|NCT01185821|Secondary|Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set)|"Free of MRI disease activity is defined as free of Gadolinium enhanced T1 lesions at any scan; free of new or enlarging T2 lesions at any scan: free of both gadolinium enhanced T1 lesions and new or enlarging T2 lesions at any scan. Number of patients analyzed = patients with at least one MRI scan during the specified time period. New lesions at a specific visit are assessed relative to the previous scheduled visit scan.~No imputation of missing scans is performed. As a result missing scans can lead to an overestimation of the proportion of patients free of a specific MRI activity."|Baseline Extension up to approximately 5 years||||percentage of participants|||Number
1409509|NCT01185821|Secondary|Number of Relapses in One Year - Annualized Relapse Rates for Overall Extension Study (ARR) (Extension Set)|"Group level ARR (raw) is calculated as the total number of relapses for all the patients in the treatment group divided by the total number of days on study for all patients in the group and multiplied by 365.25 to obtain the annual rate.~Model estimates are based on a negative binomial regression model, adjusted for treatment group, age, baseline EDSS, baseline number of Gd-enhanced T1 lesions and number of relapses in previous 2 years as covariates, with log(time on study in years) as the offset variable, using the log link."|Baseline extension up to approximately 5 years||||Group level ARR||95% Confidence Interval|Mean
1409510|NCT01185821|Primary|Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set)||Baseline Extension up to approximately 5 years||||participants|||Number
1409511|NCT01185821|Primary|Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set)|"Most infections were clinical diagnoses and were not confirmed by microbiology / virologic investigations. A patient with multiple occurrences of an infection for a preferred term is counted only once in each specific category.~Events identified as infections by the Investigator and defined as an AE with onset on or after the first dose of Extension Study drug up to and including 30 days after the date of the last dose"|Baseline Extension up to approximately 5 years||||participants|||Number
1409512|NCT01185821|Primary|Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set)|Sitting blood pressure was measured in triplicate. The categories of notably low and high values and changes are presented for systolic (SBP) and diastolic (DBP). Multiple occurrences for a patient are counted as one occurrence in this table.|Baseline Extension up to approximately 5 years||||participants|||Number
1409513|NCT01185821|Primary|Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout)|Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for >7 days. Abbreviations: washout = WO, Con=conduction|Baseline Extension up to day 10||||participants|||Number
1409514|NCT01185821|Primary|Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout)|Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for >7 days. Abbreviation: Con=conduction, IVCD=intraventricular conduction defect , WPW=Wolff-Parkinson-White syndrome|Baseline Extension up to day 10||||participants|||Number
1409515|NCT01185821|Primary|Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study.|Refer to adverse events for complete listing of serious adverse events and other adverse events. Adverse events of interest were presented in separate tables. There were no reports of macular edema.|Baseline up to approximately 5 years||||events|||Number
1409516|NCT01185782|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment period to post-treatment assessment period (Day 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.|||participants|||Number
1409517|NCT01185782|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the IMP. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Participants who discontinued from the study due to AE were also recorded.|Pretrial observation period to post-treatment assessment period (Days 35-42)|Safety population included all participants who received at least 1 dose of IMP. This was actually identical to the FAS population.|||participants|||Number
1409518|NCT01185782|Secondary|Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy|For this secondary endpoint, participants were considered to have ovulated if serum P4 level was more than or equal to 10 ng/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 during post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent ovulation|||Number
1410300|NCT01178944|Secondary|Overall Survival (OS)|Estimated using the Kaplan-Meier method and proportional hazards models.|From the date of study enrollment to the time of death from any cause, assessed up to 5 years|All treated and eligible patients.|||months||95% Confidence Interval|Median
1409519|NCT01185782|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was defined as existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Day 35-42 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent clinical pregnancy|||Number
1409520|NCT01185782|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy was defined as a positive pregnancy test (urinary beta-hCG test) on Day 28-31 of the post-treatment assessment period|Day 28-31 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent biochemical pregnancy|||Number
1409521|NCT01185782|Secondary|Single Follicle Maturation Rate|Single follicle maturation was defined as the presence of the dominant follicle with a mean diameter of 18 mm or greater without concurrent presence of other follicles of 14 mm or larger in diameter.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent single follicle maturation|||Number
1409522|NCT01185782|Secondary|Human Chorionic Gonadotropin (hCG) Cancellation Rate|hCG cancellation criterion was defined as the presence of 4 or more ovarian follicles with a mean diameter greater than or equal to 16 mm. If the hCG cancellation criterion was met, the administration of hCG was withheld. Otherwise, a single intramuscular dose of hCG 5000 IU (Japanese Pharmacopoeia- JP) was administered within 24 hours of the last ultrasound examination.|Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||percent hCG cancellation|||Number
1409523|NCT01185782|Secondary|Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter|Total dose of IMP administered was defined as the cumulative dose administered from the start of treatment with IMP until the mean diameter of the dominant follicle reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis of this parameter.|||IU||Standard Deviation|Mean
1409524|NCT01185782|Secondary|Time for Dominant Follicle to Achieve 18 mm in Mean Diameter|Dosing time length was calculated as number of days from the first administration of the IMP until the mean diameter of the dominant follicle was confirmed to have reached 18 mm.|Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc. Only participants in whom the dominant follicle reached 18 mm in mean diameter were considered for the analysis.|||days||Standard Deviation|Mean
1409525|NCT01185782|Secondary|Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter||Start of treatment period until Day 1 of post-treatment assessment period|FAS included all participants who received at least 1 dose of IMP and had no major violation of GCP such as non-compliance with the agreement, serious protocol violations, etc.|||participants|||Number
1409526|NCT01185782|Primary|Percentage of Participants With Ovulation|Participants were considered to have ovulated if serum progesterone (P4) level was greater than or equal to 5 nanogram (ng)/mL on Day 6±1 or 9±1 during the post-treatment assessment period, or if the participant became clinically pregnant.|On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)]|Full analysis set (FAS) included all participants who received at least 1 dose of IMP and had no major violation of Good Clinical Practice (GCP) such as non-compliance with the agreement, serious protocol violations, etc.|||percentage of participants|||Number
1409527|NCT01185704|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. To avoid the participant/event combination double-count AEs and SAEs are reported separately.|Day 1 up to end of study (15 days post last administration of study drug)||||participants|||Number
1409528|NCT01185704|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|10 weeks post r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||percentage of participants|||Number
1409529|NCT01185704|Secondary|Implantation Rate|Implantation rate per reporting group was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|5 weeks post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent sacs per embryo|||Number
1409530|NCT01185704|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus.|Day 2-3 post Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||transferred embryos||Standard Deviation|Mean
1409531|NCT01185704|Secondary|Number of Blastocysts|Blastocyst is an embryo, five or six days after fertilization, with an inner cell mass, outer layer of trophectoderm and a fluid-filled blastocoele cavity.|Day 5-6 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||blastocysts||Standard Deviation|Mean
1409532|NCT01185704|Secondary|Number of Embryos|Embryo is defined as the product of the zygote, two or three days after fertilization of the oocytes.|Day 2-3 post oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||embryos||Standard Deviation|Mean
1409533|NCT01185704|Secondary|Percentage of Fertilized Oocytes Retrieved|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an IVF procedure in which a single sperm is injected directly into an egg under a microscope.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent fertilized oocytes||Standard Deviation|Mean
1409534|NCT01185704|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 up to r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||international unit (IU)||Standard Deviation|Mean
1409535|NCT01185704|Secondary|Number and Quality of Oocytes Retrieved|Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body. Oocytes were classified into 4 different categories based on their quality: mature, fractured, immature and inseminated oocytes.|Oocytes retrieval day (36 +/- 2 hours post r-hCG day [end of stimulation cycle {approximately 15 days}])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||oocytes||Standard Deviation|Mean
1409536|NCT01185704|Secondary|Number of Follicles Greater Than or Equal (>=) to 17 mm (For Day 1 Protocol) or 19 mm (For Day 7 Protocol) on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||follicles||Standard Deviation|Mean
1409537|NCT01185704|Secondary|Anti Mullerian Hormone (AMH) Levels||Day 0|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1409538|NCT01185704|Secondary|Serum Progesterone (P4) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanomolar/liter (nmol/L)||Standard Deviation|Mean
1409539|NCT01185704|Secondary|Serum Estradiol (E2) Levels||Day 1|ITT population included all randomized participants who had received at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1409540|NCT01185704|Secondary|Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) Levels||Day 1|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Here n signifies those participants who were evaluated for specified category."|||International unit/liter (IU/L)||Standard Deviation|Mean
1409541|NCT01185704|Primary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 15 days])|"Intent to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1409542|NCT01185600|Secondary|Each Participant's Number of Non-serious Adverse Events|All clinical non-serious adverse events reported in the clinical chart were recorded in the study's data files. This type of events, defined as Non-Serious Adverse Events or just Adverse Events (AEs) were categorized into 5 groups: (1) Cardiovascular / respiratory; (2) renal; (3) neurologic (CNS); (4) infections; and (5) other. For each participant, the outcome measure was defined as the number of AE's he or she experienced during his/her hospital stay.|Within 30 days after CABG surgery||||Adverse events||Standard Deviation|Mean
1409543|NCT01185600|Primary|Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD235a+ red cell microparticles between at 1 hour post-surgery and at pre-surgery, i.e. levels at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery||||counts / uL||Standard Deviation|Mean
1409544|NCT01185600|Primary|Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD62E+ endothelial microparticles between 1 hour post-surgery and at pre-surgery, i.e. level at 1 hour post-surgery - level at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."|||counts / uL||Standard Deviation|Mean
1409545|NCT01185600|Primary|Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery|Difference in levels of circulating Annexin V+ microparticles between at pre-surgery and 1 hour post-surgery, i.e. level of Annexin V+ microparticles at 1 hour post-surgery - level of Annexin V+ microparticles at pre-surgery|Interval between pre-surgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."|||counts / uL||Standard Deviation|Mean
1409546|NCT01185600|Primary|Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery|Difference in levels of circulating CD41+ platelet microparticles between at pre-surgery and at 1hour post-surgery, i.e. level at 1hour post-surgery - level at pre-surgery|interval between presurgery and 1 hour post-surgery|"There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of Transfusion with unwashed RBC. Therefore, the total number is 57 instead of 59 in that group."|||counts / uL||Standard Deviation|Mean
1410394|NCT01178268|Secondary|Follow-up In-segment Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|Participants||Number
1409547|NCT01185600|Primary|Occurrence of at Least One Serious Adverse Event (SAE)|Comparison of the two groups with respect to occurrence or not of at least one SAE including sepsis, respiratory failure, multi-organ failure, anaphylactic shock, transfusion-related acute lung injury, MI, stroke, cardiac arrest.|within 30 days after CABG surgery||||participants|||Number
1409548|NCT01185600|Primary|One-year Mortality|Number participants who expired within one year after CABG surgery|Within one year after CABG surgery|During the 12 months after hospital discharge, one participant in the group of transfusion with washed RBC and 3 participants in the group of transfusion with unwashed RBC were lost to follow up.|||participants|||Number
1409549|NCT01185600|Primary|In Hospital Mortality|The number of participants who expired during hospital stay after CABG surgery|Within 30 days after CABG surgery||||participants|||Number
1409550|NCT01185561|Secondary|State–Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score|Scores on the The State–Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
1409551|NCT01185561|Secondary|State–Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score|Scores on the The State–Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
1409552|NCT01185561|Secondary|State–Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score|Scores on the The State–Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
1409553|NCT01185561|Primary|Center for Epidemiologic Studies Depression (CES-D) Score|The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.|6 Months|This analysis is restricted to participants who completed the final study visit six months after randomization.|||units on a scale||Standard Deviation|Mean
1409554|NCT01185522|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 4 months|Safety population consisted of all participants included in the study, who respected the inclusion and non-inclusion criteria and who at least one tocilizumab infusion.|||Number of Participants|||Number
1409555|NCT01185522|Secondary|Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4|Participants with tocilizumab treatment were managed according to number of tocilizumab treatment received according to Summary of Product Characteristics recommendations, as 8 mg/kg, dose duration of 1-hour, correct infusion progress; and received DMARD, methotrexate, and corticosteroids concomitantly with tocilizumab during Months 1 to 4.|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Number of Participants|||Number
1409556|NCT01185522|Secondary|Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4|Fatigue was assessed by FACIT-Fatigue scale (ranging from 0 [worse score] to 52 [better score]) and VAS fatigue (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]). Other participant reported outcomes (PROs) were VAS for pain and quality of sleep (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]), SF36 vitality score (ranging from 0 [worst] to 100 [best]) and HAD score (calculated using the 14 items and each item was scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales were summed; each resulting in a total score of 0-21). Correlation between fatigue as assessed by FACIT-Fatigue score or VAS fatigue was evaluated for all participants using a linear regression and were reported for D0 and M4.|Day 0 and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Coefficient of correlation|||Number
1409557|NCT01185522|Secondary|Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4|FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), VAS (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening in arthritis disease activity]) and SF36 vitality score (ranging from 0 [worst] to 100 [best]) were calculated at Baseline and Month 4.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Percentage of participants|||Number
1413467|NCT01153620|Secondary|Reduction in CFU|Comparison of the percentage reduction in CFU after 15, 30 and 60 minutes of treatment application|15 minutes, 30 minutes and 60 minutes|||||||
1409558|NCT01185522|Secondary|Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4|A PASS score at Day 0 and Month 4 calculated on participants with acceptable symptom state. PASS is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0) and Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available at the particular time point.|||Number of participants|||Number
1409559|NCT01185522|Secondary|Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and CRP value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. CRP values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in CRP level up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.|||Percent change||Full Range|Median
1409560|NCT01185522|Secondary|Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4|The correlation between fatigue and ESR value was evaluated for all participants at each evaluation time (on raw data at inclusion; on relative changes at M1 to M4) using a linear regression. ESR values were described as continuous variables for all participants at each evaluation time (Baseline to M4).|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with Changes in ESR values up to Month 4 were analyzed for this outcome measure. n = number of participants available at specified time points.|||Percent change||Full Range|Median
1409561|NCT01185522|Secondary|Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4|"Relative change (RC) from Baseline (BL) in disease activity included TJC and SJC was evaluated as continuous variables for all participants at each evaluation time points.~For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in TJC and SJC up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.|||Percent change||Full Range|Median
1409562|NCT01185522|Secondary|Relative Median Change From Baseline in DAS 28 and VAS Patient’s Global Assessment to Month 1, Month 2, Month 3, and Month 4|Relative change from Baseline (BL) in DAS 28 was evaluated for all participants at each evaluation time (on raw data at inclusion; at Month 1, Month 2, Month 3, and Month 4 using a linear regression. DAS-28 and VAS patient’s global assessment (PGA) were described as continuous variables for all participants at each evaluation time points (Baseline to M4). DAS 28 ranging from 0 (no disease activity) to 10 (worsening in disease activity) and VAS PGA ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening of symptoms and arthritis disease activity),|From Baseline (D0) to M 1, M 2, M 3, and M 4|Patient analysis population was considered. Participants with changes in DAS 28 up to Month 4 were analyzed for this outcome measure. n = number of participants available for particular parameters at specified time points.|||Percent change||Full Range|Median
1409563|NCT01185522|Secondary|Median Time to Onset of an Improvement of the FACIT-Fatigue Score|The time of onset of a clinically significant improvement of fatigue was defined as the time between the date of the first tocilizumab infusion and the date of the first increase of at least 4 points of the FACIT-Fatigue score (date of questionnaire completion) during 4 months of tocilizumab treatment. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score).|Up to Month 4|Patient analysis population was considered. Participants with increase of at least 4 points of the FACIT-Fatigue score were analyzed for this outcome measure.|||Months||95% Confidence Interval|Median
1409564|NCT01185522|Secondary|Correlation Between Relative Changes From Baseline of FACIT-Fatigue Score and VAS Fatigue to 4 Months of Tocilizumab Treatment|Correlation between FACIT-Fatigue score and VAS fatigue was evaluated for all participants at inclusion and after 4 months of tocilizumab treatment (relative change from baseline) using a linear regression. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity)|From Baseline (D0) to Month (M) 4|Patient analysis population was considered. Participants with Changes in FACIT-Fatigue Score and VAS Fatigue at Month 4 were analyzed for this outcome measure.|||Correlation Coefficient|||Number
1409583|NCT01185353|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104||Baseline through 24 weeks|All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.|||nanomoles/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
1410395|NCT01178268|Secondary|Follow-up In-segment Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percent Diameter stenosis|Participants|Standard Deviation|Mean
1409565|NCT01185522|Primary|Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment|"Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen.~For tender joint count (TJC), a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.~For swollen joint count (SJC), a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints."|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.|||Number of joints||Standard Deviation|Mean
1409566|NCT01185522|Primary|Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment|Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. C-reactive protein (CRP) is one of the biomarkers for the diagnosis and assessment of disease activity in RA.|At Month 4|Patient analysis population was considered. Participants who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.|||milligram per liter||Inter-Quartile Range|Median
1409567|NCT01185522|Primary|Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors|Predictive factors of fatigue were taken into account included gender, age, time since initial diagnosis, Erosive RA, disease activity score (DAS, ranging from 0 [no disease activity] to 10 [worsening in disease activity]), erythrocyte sedimentation rate (ESR), anemia, treatment with corticosteroids, doses of corticosteroids, health assessment questionnaire (HAQ, ranging from 0 [without any difficulty] to 60 [worsening or unable to do physical activities]), FACIT-Fatigue score (ranging from 0 [worse score] to 52 [better score]), visual analogue score (VAS) for fatigue, pain, quality of sleep, and global assessment (ranging from 0 [symptom-free and no arthritis symptoms] to 100 [worsening of symptoms and arthritis disease activity]), Short Form 36 (SF36) vitality score (ranging from 0 [worst] to 100 [best]), Hospital Anxiety and Depression Scale (HADS; represented as score </= 7 [no case], 7 to 10 [doubtful case], and > 10 [certain case of HAD]).|At Month 4|Patient analysis population was considered. Participants whom baseline characteristics were available at inclusion and who completed a FACIT-Fatigue score at Month 4 and had clinically significant improvement in fatigue with respect to predictive factors were analyzed for this outcome measure.|||Number of participants|||Number
1409568|NCT01185522|Secondary|Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score|FACIT-fatigue score and VAS fatigue score were fatigue assessment parameters. FACIT-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale, 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses results a total possible score of 0 (worse score) to 52 (better score). VAS fatigue score ranges from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Clinically relevant improvement is defined as >/= 4-point change from Baseline.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular time fatigue scores.|||Scores on a scale||Standard Deviation|Mean
1409569|NCT01185522|Secondary|Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue|High Erythrocyte Sedimentation Rate (ESR) was defined as (1) for participants aged up to 50 years: > 15 mm/h for men and > 20 mm/h for women, and (2) for participants aged over 50 years: > 20 mm/h for men and > 25 mm/h for women. Anemia was defined as plasma hemoglobin level <12 gram per deciliter (g/dL) for women and <13 g/dL for men. The CRP test is evaluated for an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Patient-Acceptable Symptom State (PASS) that is defined as the highest level of symptom beyond which participants consider themselves well. PASS is a 1-question assessment of how rheumatoid arthritis has affected participant in last 48 hours.|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.|||Number of participants|||Number
1409570|NCT01185522|Secondary|Baseline Disease Characteristic: DAS28, Patient’s Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters|DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/h), and patient's global assessment of disease activity (measured on a 100-mm visual analog scale, where 0 is no disease activity and 100 is maximum disease activity). The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening disease activity. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain. HAQ indicates how the disease affected participant’s activities of daily life. It consisted of 20 questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale, 0=without any difficulty to 3=unable to do. Sum of scores was divided by number of domains with a score for a total possible score of 0 (best/no difficulties to perform activities) to 3 (worst/ unable to perform activities at all).|Baseline (D0)|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment. n = number of participants available for particular parameters.|||Scores on a scale||Standard Deviation|Mean
1409571|NCT01185522|Secondary|Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count|"For tender joint count, a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints.~For swollen joint count, a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Tender joint count and swollen joint count were assessed at baseline and were used as baseline disease characteristics for assessment of rheumatoid arthritis."|Baseline (D0)|Patient analysis population was considered. n = number of participants available for particular parameters.|||Number of joints||Standard Deviation|Mean
1409572|NCT01185522|Secondary|Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies|Blood was collected for Rheumatoid Factor (RF) at Baseline and was analyzed. RF level was reported in international units/milliliter (IU/mL). All participants were assessed for anti-cyclic citrullinated protein (anti-CCP) antibodies at baseline. Number of participants with a positive RF and/or anti-CCP antibodies were reported as baseline disease characteristics.|Baseline (D0)|Patient analysis population was considered. Participants with positive RF and/or anti-CCP antibodies at baseline were analyzed for this outcome measure.|||Number of Participants|||Number
1409573|NCT01185522|Secondary|Baseline Disease Characteristics: Mean Disease Duration|Mean disease (rheumatoid arthritis) duration at inclusion was recorded for all participants as baseline disease characteristics.|Baseline (Day [D] 0)|Patient analysis population was considered. Participants for whom data of disease duration was available at baseline were analyzed for this outcome measure.|||years||Standard Deviation|Mean
1409574|NCT01185522|Primary|Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment|"Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale: 0 (not at all) to 4 (very much). The larger the participant’s response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant’s response. The sum of all responses resulted a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant’s health status. Clinically relevant improvement is defined as a >= 4-point change from Baseline.~This was performed using the last observation carried forward (LOCF) method and for participants who completed a FACIT-Fatigue score at Month 4 (completers)."|At Month 4|Patient analysis population consisted of all participants included in the study, who respected inclusion criteria, received at least one tocilizumab infusion, had an evaluable FACIT-Fatigue score at inclusion, and at least one evaluable FACIT fatigue score during treatment.|||Percentage of participants||95% Confidence Interval|Number
1409575|NCT01185509|Secondary|Circulating Tumor Cells (CTCs)|CTCs levels were determined based on established methods.|Assessed when patient comes off-study||2017-09-30|09/2017||||
1409576|NCT01185509|Secondary|Circulating Tumor Cells (CTCs)|CTCs levels were determined based on established methods.|Assessed at 6 weeks||2017-09-30|09/2017||||
1409577|NCT01185509|Secondary|Circulating Tumor Cells (CTCs)|CTCs levels were determined based on established methods.|Assessed at baseline||2017-09-30|09/2017||||
1409578|NCT01185509|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks and within 2 wks off-study; Median follow-up was 2.7 months.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1409579|NCT01185509|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).|The analysis dataset is comprised of all treated patients.|||percentage of patients||95% Confidence Interval|Number
1409580|NCT01185509|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).|The analysis dataset is comprised of all treated patients.|||percentage of patients||95% Confidence Interval|Number
1409581|NCT01185353|Secondary|Mean Change From Baseline Through Week 12 in the ENSEMBLE Minimum Data Set 1.0||Baseline, 12 weeks|Zero participants were analyzed. Assessment of ENSEMBLE Minimum Data Set 1.0 was not collected at Week 12 and therefore results are not reported for outcome measure.||||||
1409582|NCT01185353|Secondary|Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104||Baseline through 24 weeks|All randomized participants who received at least 1 dose of LY3009104 with evaluable LY3009104 PK data.|||nanomoles*hour/Liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1409584|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) Score|The FACIT-F Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (“Not at all”) to 4 (“Very much”) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, Week 12|All randomized participants who received study drug in Part A and had FACIT-F evaluated at Week 12. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409585|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Brief Pain Inventory Modified Short Form (BPI-sf Modified) Worst-Pain-in-the Past-24-hours Item Score|The BPI-sf modified is a self-administered questionnaire developed for the rapid assessment of pain. The BPI-sf modified provides information on the intensity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The questionnaire asks questions about pain relief, pain quality, and the participant's perception of the cause of pain. The BPI-sf modified uses a numeric rating scale from 0 (“No pain”) to 10 (“Pain as bad as you can imagine”). Since pain can be quite variable over a day, the BPI-sf modified asked participants to rate their pain at the time of responding to the questionnaire (right now), and also at its worst, least and average over the last 24 hours.|Baseline, Week 12|All randomized participants who received study drug and had BPI-sf worst-pain-in-the past-24-hours item evaluated at Week 12. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409586|NCT01185353|Secondary|Mean Change From Baseline to Week 12 in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains (physical functioning, bodily pain, role limitations due to physical problems and also emotional problems, general health, mental health, social functioning and vitality) and 2 component scores (PCS and MCS). The PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. The MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.|Baseline, Week 12|All randomized participants who received study drug in Part A and had SF-36 evaluated at analysis time point. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409587|NCT01185353|Secondary|Mean Change From Baseline Through Week 12 in Duration (Minutes) of Morning Stiffness|The Investigator asked participants about the duration of their morning stiffness (in minutes) in and around the joints and recorded the duration. The Investigator asked the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses.|Baseline, Weeks 4, 8, 12|All randomized participants who received study drug in Part A and had morning stiffness evaluated at analysis time points. LOCF was used to impute missing post-baseline values for Week 12 analysis.|||minutes||Standard Deviation|Mean
1409588|NCT01185353|Secondary|Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores <2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points.|||percentage of participants|||Number
1409589|NCT01185353|Secondary|Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 12 and 24|Disease Activity Score (DAS) modified to include 28-joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores <2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.|Baseline through Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had DAS28-CRP evaluated at analysis time points.|||percentage of participants|||Number
1409590|NCT01185353|Secondary|Percentage of Responders According to EULAR28 Baseline Through Weeks 76 and 128|EULAR28 categorizes clinical response based upon improvement since baseline in Disease Activity Score modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score >5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by >0.6 units but ≤1.2 units or post-baseline DAS28 score >3.2 with improvement by >1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by >1.2 units).|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had EULAR28 evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||percentage of participants|||Number
1409601|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had HAQ-DI evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409591|NCT01185353|Secondary|Percentage of Responders According to European League Against Rheumatism Responder Index Based on 28-joint Count (EULAR28) Baseline Through Weeks 12 and 24|EULAR28 categorizes clinical response based upon improvement since baseline in DAS modified to include the 28-joint count (DAS28) and post-baseline DAS28. DAS28 consists of a composite score of the following variables: TJC28, SJC28, CRP, and Patient's Global Assessment of their Disease Activity (patient's global VAS). DAS28 scores range from 1.0-9.4. EULAR28 categories include: No Response (improvement in DAS28 of ≤0.6 units or post-baseline DAS28 score >5.1 with improvement by ≤1.2 units), Moderate Response (post-baseline DAS28 ≤5.1 with improvement by >0.6 units but ≤1.2 units or post-baseline DAS28 score >3.2 with improvement by >1.2 units), and Good Response (post-baseline DAS28 score ≤3.2 with improvement by >1.2 units).|Baseline through Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had EULAR28 evaluated at analysis time points.|||percentage of participants|||Number
1409592|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in DAS28-CRP|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409593|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had DAS28-CRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409594|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain|Physician's and Patient's assessments of DA assessed using a VAS that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had physician's and participant’s assessments of disease activity and pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409595|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain|Physician's and Patient's Assessments of Disease Activity (DA) assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeters (mm), where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis was also assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had physician's and participant’s assessments of disease activity and participant’s pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409596|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in ESR|ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had ESR evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||mm/hr||Standard Deviation|Mean
1409597|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had ESR evaluated at analysis time points.|||mm/hr||Standard Deviation|Mean
1409598|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in hsCRP|hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||mg/L||Standard Deviation|Mean
1409599|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in High-Sensitivity C-Reactive Protein (hsCRP)|hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had hsCRP evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||mg/L||Standard Deviation|Mean
1409600|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in HAQ-DI Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had HAQ-DI evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1410322|NCT01178671|Primary|PTSD Severity|PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).|up to 24 weeks|intention to treat sample|||units on a scale||Standard Deviation|Mean
1409602|NCT01185353|Secondary|Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, Weeks 76 and 128|All participants who received study drug in Parts C and D and had TJC and SJC evaluated at analysis time points. LOCF was used to impute missing post-baseline values.|||units on a scale||Standard Deviation|Mean
1409603|NCT01185353|Secondary|Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, Weeks 12 and 24|All randomized participants who received study drug in Parts A and B and had TJC and SJC evaluated at analysis time points. LOCF was used to impute missing post-baseline values|||number of joints||Standard Deviation|Mean
1409604|NCT01185353|Secondary|ACR Percent Improvement (ACR-N)|ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of a) % of improvement in TJC, b) % of improvement in SJC, and c) third highest percentage of improvement of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to a range of -100 to 100 to minimize impact of outliers (greater scores indicate greater % improvement) and negative scores indicate a decline. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR-N at Week 12 had these components imputed by LOCF.|||percentage of improvement||95% Confidence Interval|Number
1409605|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR50 Response Baseline Through Week 12 - Model Based Dose Response|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR50 index at analysis time point had these components imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
1409606|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR70 Response Baseline Through Weeks 76 and 128|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
1409607|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR70 Responder Index Response Baseline Through Week 24|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR70 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
1409608|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR50 Response Baseline Through Weeks 76 and 128|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR50 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
1409655|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Plasma|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in plasma, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.~Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit15."|Baseline to 1st day of visit 15||||ratio||95% Confidence Interval|Geometric Mean
1409609|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR 50 Responder Index Response Baseline Through Week 24|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR50 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
1409610|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Response Baseline Through Weeks 76 and 128|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.|Baseline through Weeks 76 and 128|All participants who received study drug in Parts C and D. Participants who had missing components of the ACR20 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
1409611|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 24|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time points are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) * 100.|Baseline through Weeks 2, 4, 8, 12, 16, 20, 24|All randomized participants who received study drug in Parts A and B. Participants who had missing components of the ACR20 index at analysis time points had these components imputed by LOCF.|||percentage of participants|||Number
1409612|NCT01185353|Secondary|Percentage of Participants Who Achieved an ACR20 Responder Index Response Baseline Through Week 12 - Model Based Dose Response|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in RA. An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, HAQ-DI (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100. Data presented are model-based Bayesian posterior mean response rates with 95% credible interval.|Baseline through Week 12|All randomized participants who received study drug in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
1409613|NCT01185353|Primary|Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant’s physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.|Baseline through Week 12|All randomized participants who received placebo, 4 mg or 8 mg LY3009104 in Part A. Participants who had missing components of the ACR20 index at Week 12 had these components imputed by last observation carried forward (LOCF).|||percentage of participants|||Number
1409614|NCT01185340|Secondary|Change From Randomization to Week 8 in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1409615|NCT01185340|Secondary|Change From Randomization to Week 8 in Blood Pressure|Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit, and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1409616|NCT01185340|Secondary|Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409617|NCT01185340|Secondary|Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale|The Arizona Sexual Experiences (ASEX) scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) of the 5 items of the ASEX scale. Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409618|NCT01185340|Secondary|Percentage of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants at risk, multiplied by 100%. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
1409619|NCT01185340|Secondary|Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409620|NCT01185340|Secondary|Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a self-administered, 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of the maximum possible score||Standard Error|Least Squares Mean
1409621|NCT01185340|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items|The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409622|NCT01185340|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score|The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409623|NCT01185340|Secondary|Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)|Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409675|NCT01184898|Secondary|Complete Response in the Absence of Platelet Recovery|"Complete response in the absence of platelet recovery is defined as:~- Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)"|Within one week of peripheral count recovery but no later than day 42||||participants|||Number
1413468|NCT01153620|Secondary|Local Tolerability: Pruritis Burning|Local tolerability after 60 minutes of treatment application.|60 minutes|||||||
1409624|NCT01185340|Secondary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409625|NCT01185340|Secondary|Change From Randomization to Week 8 in The Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409626|NCT01185340|Secondary|Probability of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8|A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). A categorical repeated measures analysis modeled the probability of response at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.|8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||probability||Standard Error|Least Squares Mean
1409627|NCT01185340|Secondary|Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409628|NCT01185340|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement|A Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
1409629|NCT01185340|Secondary|Probability of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 at Week 8|A Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). A categorical repeated measures analysis modeled the probability of remission at each visit, and the estimated probabilities were adjusted for treatment, visit, baseline MADRS total score, and treatment-by-visit.|8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||probability||Standard Error|Least Squares Mean
1409630|NCT01185340|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score|The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. The FAsD impact subscale score ranges from 1 to 5. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409676|NCT01184898|Secondary|Complete Response|"Complete response is defined as:~Peripheral Blood Counts -Neutrophil count >1 x 109/L.~Platelet count ≥ 100 x 109/L.~Reduced hemoglobin concentration or hematocrit has no bearing on remission status.~Leukemic blasts must not be present in the peripheral blood.~Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines with < 5% blasts and no Auer rods.~Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present"|Within one week of peripheral count recovery but no later than day 42||||participants|||Number
1409631|NCT01185340|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Score|The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409632|NCT01185340|Primary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1409633|NCT01185301|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26|CDAI is a measure of disease activity derived as follows: CDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]). CDAI total score = 0 to 76. CDAI ≤ 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, > 10 to 22 = moderate disease activity, and > 22 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409634|NCT01185301|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26|SDAI is a measure of disease activity derived as follows: SDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) + CRP (mg/dL), where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]), and CRP is C-reactive protein measured in mg/dL. SDAI total score = 0 to 86. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409635|NCT01185301|Secondary|Percentage of Participants With No Radiographic Progression at Week 26|“No radiographic progression” was defined as a change from Baseline in modified Total Sharp Score (mTSS) at Week 26 of ≤ 0.5. mTSS is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409636|NCT01185301|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26|The modified Total Sharp Score (mTSS) is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 26|Intent-to-Treat population with available data at time point (observed cases).|||score on a scale||Standard Deviation|Mean
1409637|NCT01185301|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ –0.22 at Week 26|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from Baseline of ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409656|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)||||L/min||Standard Deviation|Mean
1409638|NCT01185301|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.|Baseline, Week 26|Intent-to-Treat population with non-missing baseline and at least 1 non-missing post-baseline value (baseline is defined as the last non-missing value prior to the first dose of study drug); last observation carried forward.|||units on a scale||Standard Deviation|Mean
1409639|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26|"Response, as defined by ACR 100 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 100% improvement in tender joint count; ≥ 100% improvement in swollen joint count; and ≥ 100% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409640|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26|"Response, as defined by ACR 90 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409641|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26|"Response, as defined by ACR 70 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409642|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26|"Response, as defined by ACR 50 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409643|NCT01185301|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26|"Response, as defined by ACR 20 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant value (C-reactive protein)."|Baseline, Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409644|NCT01185301|Secondary|Percentage of Participants With DAS28(CRP) Remission at Week 26|Disease remission was defined as a disease activity score, based on CRP, for 28 joints that was < 2.6 (DAS28[CRP] < 2.6). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409645|NCT01185301|Primary|Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26|Percentage of participants achieving low disease activity as defined by a clinical response (DAS28[CRP] < 3.2). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Week 26|Intent-to-Treat population; participants with a missing response were imputed as non-responders.|||percentage of participants|||Number
1409646|NCT01185288|Other Pre-specified|Serum Adalimumab Trough Concentrations at Week 24|Serum trough concentrations of adalimumab assessed at week 24 (24 weeks after the 1st dose).|Week 24|All participants with available pharmacokinetics at week 24: For Adalimumab + Low Dose Methotrexate, n = 134; for Adalimumab + High Dose Methotrexate, n = 140.|||µg/mL||Standard Deviation|Mean
1409674|NCT01184898|Secondary|Partial Response|"Partial response is defined as:~Requires that all of the criteria for complete remission be satisfied except that the bone marrow may contain ≥ 5% blasts but < 25% blasts.~A marrow with <5% blasts that contain Auer rods will also be considered a PR"|Within one week of peripheral count recovery but no later than day 42||||participants|||Number
1423328|NCT01070784|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and 52 week after||||beats/minute||Standard Deviation|Mean
1409647|NCT01185288|Secondary|Percent Change From Baseline in Medical Outcomes Study Version II (MOS) Sleep Problem Index 9 at Week 24|The least squares mean percentage change in MOS Sleep Problem Index 9 from baseline to week 24. The MOS Sleep Problem Index 9 consists of 9 questions to assess sleep, including how long it takes the participant to fall asleep (1=0 to 15 minutes, to 5=more than 60 minutes); and aspects of related to quality of sleep, including how often the participant felt that the sleep was not quiet, felt rested upon waking, awakened short of breath or with a headache, felt drowsy during the day, had trouble falling sleep, how often were awaken, had trouble staying awake during the day, and got needed amount of sleep (1=all the time; 5=none of the time). Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline MOS Sleep Problem Index value, treatment group, and prior methotrexate dose group.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
1409648|NCT01185288|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤ -0.22 at Week 24|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high dependency disability). The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from baseline of ≤ -0.22. Normal physical function is defined by HAQ-DI score of < 0.5. Negative change from baseline in the overall score indicates improvement.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
1409649|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Criteria Response at Week 24|Response, as defined by ACR70 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
1409650|NCT01185288|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Criteria Response at Week 24|Response, as defined by ACR50 criteria at week 24. A participant is a responder if the following 3 criteria for improvement from baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: physician global assessment of disease activity, participant global assessment of disease activity, participant assessment of pain, disability index of the health assessment questionnaire, and acute phase reactant value (C-reactive protein).|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
1409651|NCT01185288|Secondary|Percentage of Participants With Power Doppler Ultrasound (PD U/S) Score for Synovial Vascularity Improvement by 30% at Week 24|PD U/S assessed the severity of synovial inflammation in both hands (bilateral wrists, metacarpophalangeal joints 2, 3, 5, and metatarsophalangeal joint 5). Bilateral images based on dorsal midline imaging of the wrist, dorsal and volar imaging of metacarpophalangeal joints, and dorsal imaging alone of metatarsophalangeal joints are scored using a 4-grade scale: grade 0 or normal = normal joint (no Doppler signal); grade 1 or mild = mild synovitis (≤ 3 isolated signals); grade 2 or moderate = moderate synovitis (> 3 isolated signals or a confluent signal in < 50% of synovial area); grade 3 or marked = marked synovitis (signals in ≥ 50% of the synovial area). Each image is rated 0 to 3, for a total possible score ranging from 0 to 48 (16*0, 16*3) for 2 hands. Higher grade/score=more severe disease. Change = week 24 score - baseline score.|Baseline, 24 weeks|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed by carrying forward the value at early termination visit (LOCF).|||percentage of participants|||Number
1409652|NCT01185288|Primary|Disease Activity Score for 28 Joints Based on C-reactive Protein (DAS28[CRP]) at Week 24|The DAS28(CRP) score includes 28 tender joint counts, 28 swollen joint counts, C-reactive protein, and participant's global assessment of disease activity. Scores on the DAS28(CRP) range from 0 to 10. A DAS28(CRP) score ≥ 5.1 indicates high disease activity, and a DAS28(CRP) score < 2.6 indicates clinical remission. Least squares means and 95% CI were from 2-way ANCOVA model with effects for baseline DAS28(CRP) value, treatment group, and prior methotrexate dose group.|Week 24|All participants who were randomized and received at least one dose of study medication (intent to treat). Missing responses were imputed using last observation carried forward (LOCF).|||scores on a scale||95% Confidence Interval|Least Squares Mean
1409653|NCT01185249|Primary|The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients||Mean differences in the morning (5am) weights compared for three consecutive days. Day 1, Day 2, Day 3. Mean difference in the morning (5am) and evening (8pm) weights for three consecutive days. Day 1, Day 2, Day 3.|Patients with three consecutive days of morning and evening weights.|||kilograms||Standard Deviation|Mean
1409654|NCT01185080|Secondary|Change From Baseline of C-X-C Motif Chemokine 10 (CXCL10) in Nasal Lavage|"Change from baseline to 24 hours after last dose (day1 visit 15) of C-X-C motif chemokine 10 (CXCL10) in nasal lavage, expressed as a ratio. The ratio is calculated as day1 of visit 15 / baseline.~Number of Participants Analyzed is based on all patients with evaluable biomarker data at visit 2 and visit 15."|Baseline to 1st day of visit 15||||ratio||95% Confidence Interval|Least Squares Mean
1409823|NCT01183143|Secondary|Mean Number of Embryos Transferred||End of Stimulation period (up to a maximum 26 days)|"The ITT population included all the subjects who received at least 1 dose of the IMP. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||embryos||Standard Deviation|Mean
1409657|NCT01185080|Secondary|Absolute Mean Value of Peak Nasal Inspiratory Flow (PNIF)|"Absolute mean value of Peak Nasal Inspiratory Flow (PNIF) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)||||L/min||Standard Deviation|Mean
1409658|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit11, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 11."|Pre-dose on visit 11 (end of 3rd week of treatment)||||Scores on a scale||Standard Deviation|Mean
1409659|NCT01185080|Secondary|Absolute Mean Value of Instantaneous Total Nasal Symptom Score (TNSS)|"Absolute mean value of Instantaneous Total Nasal Symptom Score (TNSS) for pre-dose symptoms on visit 2, during treatment period. Treatment period is one month, which starts at visit 2 and ends at visit 14. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicate worse outcome.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data at visit 2."|Pre-dose on visit 2 (baseline)||||Scores on a scale||Standard Deviation|Mean
1409660|NCT01185080|Primary|of Evening Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of evening measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
1409661|NCT01185080|Primary|Mean of Morning Measurements of Peak Nasal Inspiratory Flow (PNIF) (12 Hrs)|"Mean of morning measurements of Peak Nasal Inspiratory Flow (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
1409662|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
1409663|NCT01185080|Primary|Mean of Peak Nasal Inspiratory Flow (PNIF) (10 Min)|"Mean of Peak Nasal Inspiratory Flow (absolute values) recorded immediately after TNSS scoring (recall period 10 min), during Allergen challenge period. The Mean is calculated over the Allergen challenge period, which is a seven day period. The patient will breathe out as much as he can. Then a mask (Portable Inspiratory Flow Meter) will be placed over the nose and mouth and the patient will inspire forcefully through the nose while the lips remain tightly closed. The highest PNIF (L/minute) out of 3 measurements will be recorded.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.||||L/min||Full Range|Least Squares Mean
1409664|NCT01185080|Primary|Mean of Evening Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of evening measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During the evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
1409824|NCT01183143|Secondary|Duration of Ovarian Stimulation With GONAL-f®|Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment.|Up to 1 year|The ITT population included all the subjects who received, at least 1 dose of the IMP.|||days||Full Range|Median
1409665|NCT01185080|Primary|Mean of Morning Measurements of Reflective (12 Hrs) Total Nasal Symptom Score (TNSS)|"Mean of morning measurements of Reflective Total Nasal Symptom Score (absolute values) of symptoms over the last 12 hours during allergen challenge, collected in patient diary. The Mean is calculated over the evening of the 1st day to the morning of 8th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose. Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During evening of the 1st day to the morning of the 8th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
1409666|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over 4th day to 7th day of the Allergen challenge period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome. Allergen challenge period starts 24 hrs post last dose.~Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 4th day to 7th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
1409667|NCT01185080|Primary|Mean of Reflective (10 Min) Total Nasal Symptom Score (TNSS)|"Mean of Reflective Total Nasal Symptom Score (absolute values) for symptoms over the last 10 minutes after allergen challenge, collected during clinic visits. The Mean is calculated over the Allergen challenge period, which is a seven day period. Each individual symptom is scored 0 to 3, which 0 = Absence of symptoms, 1 = Mild symptoms, 2 = Moderate symptoms and 3 = Severe symptoms. The scores of each individual symptom (runny nose, blocked nose and the maximum score of nasal itching or sneezing) will be added together to give a TNSS of 0 to 9. TNSS Score 0 indicates better outcome and TNSS score 9 indicates worse outcome.~Allergen challenge period starts 24 hrs post last dose (visit 15). Number of Participants Analyzed is based on all patients with evaluable efficacy and/or biomarker data from the challenge period (Visit 15)."|During 1st day to 7th day of Allergen challenge period.||||Scores on a scale||Full Range|Least Squares Mean
1409668|NCT01185028|Primary|Number of Participants With Adverse Events|Adverse events determined and evaluated by patient reporting and the DAIDS toxicity table.|2 years||||adverse events|||Number
1409669|NCT01185028|Secondary|Tolerability|Proportion of individuals that discontinued study drug|2 years|||||||
1409670|NCT01185028|Secondary|Sustained Viral Response Rate|Proportion of participants that are HCV negative 6 months after treatment completion|72 weeks||||participants|||Number
1409671|NCT01184989|Primary|Dabigatran Concentration in Plasma, Measured With HPLC-MS/MS|Dabigatran Concentration in Plasma, measured with HPLC-MS/MS - Most relevant timepoints are reported here, ie timepoints of day 6|At day 6 before drug intake (di), at 1h, 2h, 4h, 8h and 24h after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1409672|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Central Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured centrally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting|||measurements estimated as above LLOQ|Participants||Number
1409673|NCT01184989|Primary|Dabigatran Concentration in Plasma, Estimated From Local Hemoclot®|"The Hemoclot® test kit measures the dTT (diluted Thrombin time). In the present trial, as a first step, the dTT in calibration samples that had known Dabigatran concentrations was measured locally with the Hemoclot® test kit, and a linear calibration curve was fitted to the data from the calibration samples. Thereafter, for each patient at each time-point, the dTT was measured with the Hemoclot® kit and the Dabigatran concentration was read off from the calibration curve.~These estimated concentrations are compared with concentrations measured in parallel with HPLC-MS/MS.~As the trial objective is the method comparison and not the detection of the absolute concentrations of either of the methods, the result is reported as a relative bioavailability [%], see Statistical Analysis 1 below. Only concentrations >= LLOQ (Lower Limit of concentration) are included in the quantitative comparison."|Screening, day of surgery 1 hour (h) and 2h after drug intake (di) for late finalization of surgery, 4h and 8h after di for early finalization of surgery, 15 minutes (min) before di at days 2, 3, 4, 5 and 6, at day 6 also 1h, 2h, 4h, 8h and 24 after di|Correct calculation set: all patients of the Per Protocol set (PPS) (patients with at least one pair of observations for both PD and PK parameters without important protocol violations) and additionally all patients of the TS whom the only reason for not being in the PPS was the non-influential forbidden concomitant medication or vomiting|||measurements estimated as above LLOQ|Participants||Number
1409677|NCT01184898|Primary|Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC|"Percent change compared between response groups (responder vs nonresponder).~This outcome measure only includes patients who survived to outcome assessment."|From pre- to post-treatment||||percentage change in leukemic blasts||Full Range|Mean
1409678|NCT01184885|Secondary|Complete Response|"To describe response rates to hyper-CVAD and sirolimus in adults with ALL and other aggressive lymphoid malignancies.~Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)."|Every 21 days or as count recovery allows (at least 14 days apart) up to 24 weeks||||participants|||Number
1409679|NCT01184885|Secondary|Induction Mortality|Induction mortality. Hyper-CVAD/ Rapamycin will be considered acceptable if induction mortality does not exceed 31% in patients older than 60, or 15% in those younger than 60|18 months|||||||
1409680|NCT01184885|Primary|Number of Participants With Count Recovery That Allows for Starting a Phase II Study to Evaluate Response Rates and Survival|"This will be assessed by evaluating the tolerability of this regimen compared to historical controls who received Hyper-CVAD or Hyper-CVAD/ Rituximab regimens. The treatment will be designated feasible for an individual subject if in 80% of chemotherapy cycles the subject has count recovery that allows for starting the subsequent cycle by Day 28. Count recovery is defined as ANC (absolute neutrophil count) of > 0.5 x 10^9/L and platelet count > 50 x 10^9/L.~Hyper-CVAD/Rapamycin will be deemed acceptable if it is feasible to administer in 80% or more of subjects."|18 months||||participants|||Number
1409681|NCT01184872|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||Continuously from baseline up to 28 days after end of antibiotic treatment.|The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.|||participants|||Number
1409682|NCT01184872|Secondary|Duration of Treatment (Intravenous and Oral)|Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis set (FAS) comprised all patients to whom study treatment had been assigned at randomization.|||Days||Standard Deviation|Mean
1409683|NCT01184872|Secondary|Duration of Treatment (Intravenous)|Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.|Up to 28 days|The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned at randomization.|||Days||Standard Deviation|Mean
1409684|NCT01184872|Secondary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.|Baseline and 7 to 14 days after end of therapy|Population analyzed consisted of patients from the clinically evaluable population who had independent microbiological assessments.|||participants|||Number
1409685|NCT01184872|Primary|Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit|Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.|Baseline and 7 to 14 days after end of therapy|The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for complicated skin and soft tissue, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.|||participants|||Number
1409686|NCT01184859|Secondary|Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)|Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.|Days 4- 32|Safety population which included all randomised and exposed participants. Participants were analysed according to the actual treatment received.|||participants|||Number
1409687|NCT01184859|Secondary|Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32|The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||units on a scale||Standard Deviation|Mean
1409709|NCT01184846|Secondary|Severity of AEs Per Infusion|"The severity of each AE was to be graded by the investigator as follows:~Mild: Symptoms were easily tolerated and there was no interference with daily activities.~Moderate: Discomfort enough to cause some interference with daily activities.~Severe: Incapacitating with inability to work or do usual activity."|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.|||AE rate per infusion|Participants||Number
1409710|NCT01184846|Secondary|Frequency of Adverse Events (AEs)|Overall rate of AEs per infusion.|For the duration of the study, up to 34 weeks|The safety data set (SDS) comprised all subjects treated with the study drug.|||AE rate per infusion|Participants||Number
1409688|NCT01184859|Secondary|Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32|N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).|Approximately Day 4 (start of period 2) and Day 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||units on a scale||Standard Deviation|Mean
1409689|NCT01184859|Secondary|Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32|Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||nocturnal urine volume / 24-hour urine||Standard Deviation|Mean
1409690|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||ml/kg||Standard Deviation|Mean
1409691|NCT01184859|Secondary|Change From Baseline in 24-Hour Urine Volume at Approximately Day 32|Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||ml||Standard Deviation|Mean
1409692|NCT01184859|Secondary|Change From Baseline in Nocturnal Urine Volume at Approximately Day 32|Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||ml||Standard Deviation|Mean
1409693|NCT01184859|Secondary|Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32|Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||voids||Standard Deviation|Mean
1409694|NCT01184859|Secondary|Change From Baseline in Number of Daytime Voids at Approximately Day 32|Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||voids||Standard Deviation|Mean
1409695|NCT01184859|Secondary|Change From Baseline in Total Sleep Time at Approximately Day 32|"Total sleep time is defined as the time spent asleep from initial sleep to final awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||minutes||Standard Deviation|Mean
1409711|NCT01184846|Secondary|Immunoglobulin G (IgG) Level||At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement.|||mg/dL||Standard Deviation|Mean
1410396|NCT01178268|Secondary|Follow-up In-segment Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
1409696|NCT01184859|Secondary|Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2|"Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening.~Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings."|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||minutes||Standard Deviation|Mean
1409697|NCT01184859|Secondary|Time When Urine Production <0.12 ml/kg/Min|Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||hours||Standard Deviation|Mean
1409698|NCT01184859|Secondary|Area Under the Urine Production Curve (AUCurine Prod)|Area under the urine production curve, from dose administration to end of action (AUCurine prod)|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||h*mL||Standard Deviation|Mean
1409699|NCT01184859|Secondary|Area Under the Urine Osmolality Curve (AUCosm)|Area under the urine osmolality curve, from dose administration to end of action (AUCosm).|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||h*mOsm/kg||Standard Deviation|Mean
1409700|NCT01184859|Primary|Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2|Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.|3 days between study days -6 to 0 (Baseline), and days 25 to 32|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance. Missing values post baseline were imputed using last observation carried forward (LOCF) where at least one post baseline measurement was available at a visit before the missing observation.|||nocturnal voids||95% Confidence Interval|Least Squares Mean
1409701|NCT01184859|Primary|Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1|Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.|Day 1|Per protocol population, consisting of treated participants without major protocol violations and with >=80% treatment compliance.|||hours||Standard Deviation|Mean
1409702|NCT01184846|Secondary|Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.|Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint.|At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)|The SDS comprised all subjects treated with the study drug.|||participants|||Number
1409703|NCT01184846|Secondary|Mean Change in Body Temperature During Infusion|Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.|||°C||Standard Deviation|Mean
1409704|NCT01184846|Secondary|Mean Change in Pulse Rate During Infusion|Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug|||beats per minute||Standard Deviation|Mean
1409705|NCT01184846|Secondary|Mean Change in Systolic and Diastolic Blood Pressure During Infusion|Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported.|At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.|The SDS comprised all subjects treated with the study drug.|||mm Hg||Standard Deviation|Mean
1409706|NCT01184846|Secondary|Relatedness of AEs Per Subject|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.|||percentage of subjects|||Number
1409707|NCT01184846|Secondary|Relatedness of AEs Per Infusion|The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.|For the duration of the study, up to 34 weeks|The SDS comprised all subjects treated with the study drug.|||AE rate per infusion|Participants||Number
1409708|NCT01184846|Secondary|Severity of AEs Per Subject|"The severity of each AE was to be graded by the investigator as follows:~Mild: Symptoms were easily tolerated and there was no interference with daily activities.~Moderate: Discomfort enough to cause some interference with daily activities.~Severe: Incapacitating with inability to work or do usual activity."|34 weeks|The SDS comprised all subjects treated with the study drug.|||percentage of subjects|||Number
1409712|NCT01184846|Secondary|Change in Medical Research Council Sum Scale (MRC)|"The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.~The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.|||score on a scale||95% Confidence Interval|Mean
1409713|NCT01184846|Secondary|Change in Maximum Grip Strength|Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement.|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.|||kPa||95% Confidence Interval|Mean
1409714|NCT01184846|Secondary|Change in Adjusted INCAT Score|"The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis.~The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates ‘no upper limb problems’ and arm = 5 indicates ‘inability to use either arm for any purposeful movement’, and leg = 0 indicates ‘walking not affected’, and leg = 5 indicates ‘restricted to wheelchair, unable to stand and walk a few steps with help’). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Up to 34 weeks|The FAS includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. Analysed subgroups include all subjects and IVIG-pretreated and IVIG-untreated subjects from baseline to completion, and IVIG-pretreated subjects from last IVIG treatment to completion.|||score on a scale||95% Confidence Interval|Mean
1409715|NCT01184846|Primary|Responder Rate|"Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score.~Responders were defined as those subjects who: 1) demonstrated a “clinically meaningful improvement” between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with “clinically meaningful improvement” at the last study visit.~Clinically meaningful improvement” was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0."|25 weeks|The full analysis set (FAS) includes all subjects who received at least one dose of IgPro10, regardless of whether or not the subject recorded an efficacy variable measurement. The valid cases set (VCS) consists of all FAS subjects without any major protocol deviation (ie, the subjects who participated in the study as intended).|||percentage of responders||95% Confidence Interval|Number
1409716|NCT01184755|Primary|Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages)|The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP.|8 weeks|These were patients who completed both the baseline and 8-week Ambulatory BP measures.|||mm Hg||Standard Deviation|Mean
1409717|NCT01184417|Secondary|Number of Study Patients With Mortality as a Measure of Safety and Tolerability|mortality in study patients|1 year||||participants|||Number
1409718|NCT01184417|Secondary|Number of Study Patients With Seizure as a Measure of Safety and Tolerability|Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).|1 year||||participants|||Number
1409719|NCT01184417|Secondary|Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability|"Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a bedside sitter to observe the patient and provide additional safety supervision during any portion of their hospitalization."|1 year||||percentage of participants|||Number
1409720|NCT01184417|Secondary|Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability|"The outome answeres the question Did the study patient require endotracheal intubation, or not. This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation."|1 year||||participants|||Number
1409721|NCT01184417|Secondary|Length of Stay|hospital LOS, per patient, in hours from admission to discharge|1 year||||hours||Inter-Quartile Range|Median
1409722|NCT01184417|Primary|Total Lorazepam Required Per Patient Per Admission|How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.|1 year||||milligrams||Standard Deviation|Mean
1409723|NCT01184417|Primary|Percentage of Patients Requiring ICU Admission|admission to intensive care unit|1 year||||percentage of participants|||Number
1409724|NCT01184417|Primary|Number of Patients Requiring Continuous Lorazepam Infusion|"All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or lorazepam drip). Thus, continuous lorazepam infusion is a yes or no variable (i.e. continuous infusion, or not)."|1 year||||participants|||Number
1410397|NCT01178268|Secondary|Follow-up In-stent Angiographic Binary Restenosis (ABR)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|Participants||Number
1409725|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Anterior Tongue Strength (KPa) From Baseline With 16-week of High Dose Inhaled FP Treatment.|The Iowa Oral Performance Instrument (IOPI) will be used. This instrument has a standard-sized air-filled polymer balloon, called tongue sensor or bulb, which can be inserted between the tongue blade and the roof of the mouth. Anterior tongue strength (KPa) reported. Subjects were divided into 3 subgroups: improved (lower anterior tongue strength KPa), unchanged, or worsened (higher anterior tongue strength KPa).|16 weeks||||participants|||Number
1409726|NCT01184118|Secondary|Number of Participants With Improved, Unchanged, and Worsened Sleep Disorders Questionnaire (SA-SDQ) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Secondary goals include evaluating effects of this medication on severity of obstructive sleep disordered breathing (SDB) (validated by Sleep Disorders Questionnaire (SA-SDQ)). Subjects were divided into 3 subgroups: improved (less negative SA-SDQ score), unchanged, or worsened (more negative SA-SDQ score).|16 weeks||||participants|||Number
1409727|NCT01184118|Primary|Number of Participants With Improved, Unchanged, and Worsened Critical Closing Pressure (Pcrit) From Baseline With 16-week of High Dose Inhaled FP Treatment.|Upper airway (UAW) collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes. Subjects were divided into 3 subgroups: improved (more negative Pcrit), unchanged, or worsened (less negative Pcrit).|16 weeks||||participants|||Number
1409728|NCT01184079|Secondary|Safety Profile|Total proportion of side effects reported after any dose, compared by arm.|1 week after vaccination|Intention-to-treat|||percentage of doses with side effects|||Number
1409729|NCT01184079|Secondary|Compliance With 3rd Dose|Determine the compliance of the men for the timing of the third dose.|at 3rd dose (i.e., at month 6 or month 12, depending on arm)||||participants|||Number
1409730|NCT01184079|Primary|Immunogenicity After Dose 3|Geometric mean titer (GMT) and 95% confidence intervals around titer 1 month after dose 3 in per protocol population, comparing the two groups.|1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months)|Intention-to-treat|||mM units/ml||95% Confidence Interval|Geometric Mean
1409731|NCT01184053|Secondary|Associations Between Markers of Angiogenesis (e.g. VEGF) With Response|We will request a blood sample to measure vascular endothelial growth factor (VEGF) as well as other angiogenic factors and correlate levels to response to arsenic trioxide. Such effects have been observed in cultured cell lines and animal models, as well as clinical studies.|4 years|No patients achieved a CR or PR response, no angiogenesis was performed.||||||
1409732|NCT01184053|Secondary|Overall Survival||5 years|All patients who received treatment|||days||95% Confidence Interval|Median
1409733|NCT01184053|Secondary|Progression Free Survival in Patients Treated With Trisenox®|Progression-Free survival is the period from start of treatment until disease progression, death, or date of last contact.|28 days||||Participants|||Count of Participants
1409734|NCT01184053|Primary|Objective Response (CR+PR) Rate of Subjects Given Trisenox|To estimate the objective response (CR+PR) rate (as defined by the Gynecologic Oncology Group [GOG] RECIST Criteria)of Trisenox® in women with recurrent or metastatic endometrial cancer when administered at 0.25 mg/kg/day for 5 consecutive days (D1-5) every 4 weeks.|28 days||||Participants|||Count of Participants
1409735|NCT01184014|Primary|Mean Blood Glucose of All Readings|Starting 3 hours after the initial index blood glucose (BG) >180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is > 5 days|starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days||||mg/dL||Standard Deviation|Mean
1409736|NCT01183975|Primary|Mean Excess Weight Change|Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).|3 years follow up||||percent change in excess weight||Standard Deviation|Mean
1409737|NCT01183975|Primary|Mean BMI Change|Mean change in BMI for valid subjects|3 years follow-up|517 valid patients analyzed|||kg/m^2||Standard Deviation|Mean
1409738|NCT01183858|Secondary|Overall Survival (OS) at the End of Study|OS defined as the time from randomization to the date of death due to any cause.|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||months||95% Confidence Interval|Median
1409739|NCT01183858|Primary|Progression-Free Survival (PFS) at the End of Study|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||weeks||95% Confidence Interval|Median
1409740|NCT01183858|Secondary|Number of Participants With Adverse Events (AEs) at the End of the Study|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death."|Randomization to End of Study: 14 October 2010 – 7 February 2014 (Up to 39.8 months)|Safety population included all randomized participants who received at least one dose of study drug.|||participants|||Number
1410398|NCT01178268|Secondary|Follow-up In-stent Percent Diameter Stenosis (DS)||≥13 months|The number of participants with angiographic follow up available was analysed.|||percent Diameter stenosis|Participants|Standard Deviation|Mean
1409741|NCT01183858|Secondary|Time to Progression (TTP)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||weeks||95% Confidence Interval|Median
1409742|NCT01183858|Secondary|Disease Control Rate (DCR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||percentage of participants||95% Confidence Interval|Number
1409743|NCT01183858|Secondary|Overall Response Rate (ORR)|Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||percentage of participants||95% Confidence Interval|Number
1409744|NCT01183858|Secondary|Overall Survival (OS)|OS defined as the time from randomization to the date of death due to any cause.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||months||95% Confidence Interval|Median
1409745|NCT01183858|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)|Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.|||weeks||95% Confidence Interval|Median
1409746|NCT01183780|Secondary|Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab||Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17|All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax.|||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
1409747|NCT01183780|Secondary|Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)*100.|Cycles 1, 3, 5, and 30-Day FU|All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.|||percentage of participants|||Number
1409748|NCT01183780|Secondary|Change From Baseline in EuroQol- 5D (EQ-5D)|The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline and 30-Day Follow-Up (FU) up to 171 Weeks|All randomized participants who had EQ-5D assessed at baseline and 30-day FU.|||units on a scale||Standard Deviation|Mean
1409749|NCT01183780|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status|The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.|Baseline Up to 171 Weeks|All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .|||units on a scale||Standard Deviation|Mean
1409764|NCT01183689|Secondary|Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)|Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance|2 years|Mean changes among all participants with measurements at Year 2|||Mean Change from Baseline in mg/dl||Standard Error|Mean
1410399|NCT01178268|Secondary|Follow-up In-stent Minimum Lumen Diameter (MLD)||≥13 months|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
1409750|NCT01183780|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.|Randomization until Disease Progression Up to 38.01 Months|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1409751|NCT01183780|Secondary|Progression-free Survival (PFS) Time|PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.|Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.|||months||95% Confidence Interval|Median
1409752|NCT01183780|Primary|Overall Survival (OS)|OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.|Randomization to Date of Death from Any Cause Up to 39.36 Months|All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.|||months||95% Confidence Interval|Median
1409753|NCT01183728|Secondary|Indication of Efficacy|"Clinical exploration, questionaires (VAS, WOMAC, Lequesne Index, SF-36 life quality) at all the periods. To evaluate effectiveness through development of criteria for quantitative MRI (Cartigram) denoting regeneration of articular cartilage at 6, 12 and 24 months after the implantation of MSV.~Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.~Mean (SD) are expressed as the percent of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =5 is considered normal (can be attained by chance). Values above 5 are considered pathological. The worst possible is 100."|0, 6, 12, 24 months||||percentage of values||Standard Deviation|Mean
1409754|NCT01183728|Primary|Feasibility and Safety of the Implementation of MSV in the Treatment of Osteoarthritis of the Knee.|"Clinical review, questionaires (VAS - Visual Analogue Scale (a psychometric response scale which can be used for subjective measurements of knee pain), WOMAC - Western Ontario and McMaster Universities Osteoarthritis Index (questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip), Lequesne Index (is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis)), SF36 life quality - Short Form 36 (is a questionnaire for the detection of changes in quality of life)).~In all cases, the scale was from 0 to 100%. Measurements were performed before cell transplantation (0) and 3, 6, 12 and 24 months afterwards depending on the questionnaire. For VAS, WOMAC and Lequesne, lower values represent a better outcome. For SF-36, higher values represent a better outcome.~VAS-DA, VAS for pain associated to daily activities. VAS-SP, VAS for pain associated to sports activities."|0, 3, 6, 12 and 24 months||||units on a scale||Standard Deviation|Mean
1409755|NCT01183689|Other Pre-specified|6 Year Weight Changes|Changes from baseline to year 6 in body weight|6 years||2018-05-31|05/2018||||
1409756|NCT01183689|Secondary|Self-weighing|Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week|2 years||||Participants|||Count of Participants
1409757|NCT01183689|Secondary|Change in Waist Circumference (cm)|Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2.|Change from baseline to 2 years||||centimeters||Standard Error|Mean
1409758|NCT01183689|Secondary|Total Energy Dietary Intake Per Day (Kcals)|"Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy.~REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335."|Changes from baseline to 2 years in kilocalories||||kilocalories||Standard Error|Mean
1409759|NCT01183689|Secondary|Insulin Resistance|We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL).|Change from baseline to 2 years||||HOMA-IR||Standard Error|Mean
1409760|NCT01183689|Secondary|Depression Symptomatology|Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., & Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology.|2 years|All Participants with 2 year data|||units on a scale||Standard Error|Mean
1409761|NCT01183689|Secondary|Mean Change in Fasting Insulin From Baseline to 2 Years|Mean change in fasting insulin (uU/ml) from baseline to 2 years|2 years||||Mean changes at 2 years in uU/ml||Standard Error|Mean
1409762|NCT01183689|Secondary|Mean Change in Fasting Glucose From Baseline to 2 Years|Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures|2 years|All participants with measurements at 2 years|||Mean change from baseline in mg/dl||Standard Error|Mean
1409763|NCT01183689|Secondary|Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)|Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl)|2 years|Mean changes from baseline among all participants with year 2 measures|||Mean change in LDL-C in mg/dl||Standard Error|Mean
1409765|NCT01183689|Secondary|General Health Index|"The General Health Index, a one-item question from the CDC’s Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes.~Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention"|Changes from baseline to 2 years||||2 year changes in units on a scale||Standard Error|Mean
1409766|NCT01183689|Secondary|Rigid Dietary Control|"Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control.~REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation."|Changes from baseline to 2 years||||2 year changes in units on a scale||Standard Error|Mean
1409767|NCT01183689|Secondary|Flexible Dietary Control|"Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control.~REF: Westenhoefer, J., Stunkard, A. J., & Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64."|Changes from baseline to 2 years||||units on a scale||Standard Error|Mean
1409768|NCT01183689|Secondary|Disinhibition|"The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0–16, with higher scores reflecting greater levels of disinhibition).~REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation."|Changes at 2 years||||Units on a scale||Standard Error|Mean
1409769|NCT01183689|Secondary|Dietary Restraint: Mean Change From Baseline to 2 Years|"The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint).~Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation."|2 years||||Units on a scale||Standard Error|Mean
1409770|NCT01183689|Secondary|Obesity|Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations.|3 years||||percentage of participants||Standard Error|Mean
1409771|NCT01183689|Secondary|Mean Changes From Baseline to 2 Years in Total Cholesterol|Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl)|2 years|All participants with Year 2 measures|||mg/dl||Standard Error|Mean
1409772|NCT01183689|Secondary|Mean Changes From Baseline in Diastolic Blood Pressure|Change from baseline to 2 years in diastolic blood pressure|2 years|All participants providing data at 2 years|||mmHg||Standard Error|Mean
1409773|NCT01183689|Secondary|Mean Changes in Systolic Blood Pressure|Compare changes in systolic blood pressure across the three intervention groups|Measured at 2 Years|All participants with measurements at Year 2|||mmHg||Standard Error|Mean
1409774|NCT01183689|Secondary|Mean Weight Changes|Mean differences in weight changes among intervention groups at 24 months post-randomization|2 years||||kilograms||Standard Error|Mean
1409775|NCT01183689|Secondary|Weight Gain 1 Pound or More at Any Time Over Follow-up|Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status.|3 years||||percentage gaining 1 pound or more among||Standard Error|Mean
1409776|NCT01183689|Primary|Weight Changes From Baseline Over Follow-up.|Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.|3 years||||kilograms||Standard Error|Mean
1409777|NCT01183650|Primary|Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants|||hours||Full Range|Median
1409778|NCT01183650|Primary|Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710||1 day and 10 days|All enrolled participants|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1409779|NCT01183650|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710|AUC for Day 1 is reported as AUC(tau [t], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state [ss]), which is AUC during one 24-hour dosing interval at steady-state.|1 day and 10 days|All enrolled participants|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1409780|NCT01183546|Secondary|Shoulder Peak Resultant Moment|Shoulder Peak Resultant Moment during wheelchair transfers was calculated using an inverse dynamics model approach. Inputs into the model included forces recorded at the hands during transfers, three-dimensional motion trajectories of markers placed on the upper limbs and trunk, and subject's anthropometric data.|Baseline Testing and at Followup Testing (4 weeks)||||Newton-meter/kilogram||Standard Deviation|Mean
1409781|NCT01183546|Primary|Transfer Performance (TAI Scores Part 1)|"Part 1 of the TAI is comprised of 15 items which are scored yes (1 point) when the subject performs the specified skill correctly and no (0 points) when the subject performs the skill incorrectly or (N/A) which means the item does not apply. The part 1 summary score is the summation of each item's score multiplied by 10, and then divided by the number of applicable items, ranging from 0 to 10."|Baseline Testing and at Followup Testing (4 weeks)||||units on a scale||Standard Deviation|Mean
1423329|NCT01070784|Primary|Vital Signs- Pulse Rate|Change from baseline|Baseline and 52 week after||||beats/minute||Standard Deviation|Mean
1409783|NCT01183533|Secondary|90-day Modified Rankin Scale (mRS) Score 0 or 1|Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention.|90 days|^ Note: 2 patients were not available for 90-day follow-up assessments.|||participants|||Number
1409784|NCT01183533|Primary|Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients|The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.|24 hours||||cases.|||Number
1409785|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing multiple fraction treatment|||percentage of participants|||Number
1409786|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Multiple Fraction Radiotherapy|"Percentage of participants in the multiple fraction arm experiencing no nausea, vomiting, and retching was assessed.~Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame."|During radiotherapy (5 days) and the 24 hours following radiotherapy|Patients undergoing multiple fraction treatment|||percentage of participants|||Number
1409787|NCT01183481|Secondary|Control Rate of Delayed Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants in the single fraction arm experiencing no nausea, vomiting, and retching was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries."|Days 2-10 following radiotherapy|Patients undergoing single fraction treatment|||percentage of participants|||Number
1409788|NCT01183481|Secondary|Control Rate of Acute Phase Nausea, Vomiting, and Retching in Patients Undergoing Single Fraction Radiotherapy|"Percentage of participants experiencing no nausea, vomiting, and retching during the acute phase was assessed.~Assessments of nausea, vomiting, and antiemetic use will be taken daily following the radiation therapy based on patient self-report nausea/vomiting diaries."|Day of radiotherapy and 24 hours following|Patients undergoing single fraction treatment|||percentage of participants|||Number
1409789|NCT01183481|Secondary|The Complete RINV Prophylaxis Rate (Acute and Delayed Phases), the Partial Emesis Control Rate, the Safety of the Combined Regime, QOL Issues, the Time to the First Emetic Event and Use of Rescue Medication .|Data will be measured by research staff at baseline and patient self-report nausea diaries will be taken on each day within this time frame.|From day of radiotherapy to 10 days following radiotherapy|||||||
1409790|NCT01183481|Primary|The Proportion of Patients Experiencing no Vomiting and no Nausea, Without Use of Any Rescue Antiemetic Medication(s), From Days 2-10 Following the Radiation Therapy (Delayed RINV).|Assessments of nausea, vomiting, and antiemetic use will be taken daily within 2-10 following the radiation therapy based on patient self-report nausea/vomiting diaries.|Days 2-10 following radiotherapy||||participants|||Number
1409791|NCT01183468|Primary|C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52|No results for the primary outcome measure are available since the study was terminated prior to reaching the outcome measure time frame of 52 weeks.|Week 52|Enrolled Sample||||||
1409792|NCT01183390|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1409793|NCT01183390|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1409794|NCT01183312|Secondary|Electroencephalogram (EEG) Power|EEG signals reflect the state of excitability of the cerebral cortex and correlate highly with levels of behavioral arousal. This is quantifiable as ‘power’ of the signal (microvolts squared/signal frequency). The EEG signals will be acquired and stored for off-line power analysis and comparison between treatment conditions.|following drug administration|EEG signal processing analyses have not been performed. This would require an additional set of extensive analyses, very distinct from the statistics performed for the other study outcomes. EEG data were collected for possible future analyses, pending resources and expertise, and as such we have no data to report here.||||||
1409795|NCT01183312|Secondary|Change in Stanford Sleepiness Scale|The Stanford Sleepiness Scale (SSS) is a subjective rating of sleepiness, with score ranging from 1 to 7, where higher values reflect more severe sleepiness. The measure used was change in SSS from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||units on a scale||Standard Deviation|Mean
1409825|NCT01183143|Secondary|Evaluation of the Information Given to the Subjects on the Pen’s Utilization|Subjects were provided with the information on Pen's utilization via training session and in the form of information brochure. Subjects assessed both the methods using the following responses: satisfactory, satisfactory, unsatisfactory and very unsatisfactory.|Up to 1 year|"The ITT population. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome and Number Analyzed signifies those who were evaluable for the specified category."|||subjects|||Number
1409796|NCT01183312|Secondary|PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT|At the end of the 10 minute PVT testing period, subjects were asked to rate their current level of sleepiness along a line, which was transformed into a numeric value from 1-10, such that high levels indicated more severe subjective sleepiness. The measure used was the change in this rating from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||units on a scale||Standard Deviation|Mean
1409797|NCT01183312|Secondary|PVT Additional Measure #4, Change in False Response Frequency|The false response frequency is defined as the number of button presses when no stimulus is presented. The measure used was the change in false response frequency from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||number of false starts||Standard Deviation|Mean
1409798|NCT01183312|Secondary|PVT Additional Measure #3, Change in Optimum Response Times|The optimum response times is defined as the reciprocal of the reaction time averaged across the fastest 10% of responses. The measure used was the change in optimum response time from baseline to following drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||1/msec||Standard Deviation|Mean
1409799|NCT01183312|Secondary|PVT Additional Measure #2, Change in Duration of Lapse Domain|The PVT duration of lapse domain is defined as the reciprocal of the reaction time averaged across the slowest 10% of responses. The measure used was the change in duration of lapse domain from baseline to drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||1/msec||Standard Deviation|Mean
1409800|NCT01183312|Secondary|PVT Additional Measure #1, Change in Lapse Frequency|A PVT lapse is defined as a reaction time exceeding 500 msec following the presentation of a single stimulus, which are then summed for the entire 10 minute PVT testing period. The measure used was the change in the frequency of lapses from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||number of lapses during PVT testing||Standard Deviation|Mean
1409801|NCT01183312|Primary|Change in Psychomotor Vigilance Task (PVT) Median Reaction Time|The PVT measures the reaction time to button press following the presentation of a visual stimulus, reported here as the median reaction time for multiple presentations during the 10 minute task. The measure used was the change in median reaction time from baseline to drug administration, where the median reaction time at each of the time points (below) was averaged to provide a single on-treatment value for median reaction time. The measure was then calculated as baseline value - treatment value, such that higher numbers denote improvement from baseline.|10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)|Intention to treat (all randomized subjects were included)|||msec||Standard Deviation|Mean
1409802|NCT01183260|Secondary|Functional and General Health Outcome Assessments|"Analyze and compare functional and general health outcomes of these patients, based on Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems:~SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health.~SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health.~HOOS Pain assesses pain in the hip~HOOS Symptoms assesses symptoms such as stiffness in the hip~HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.)~HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.)~HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life"|2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative|"By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group:~We were unable to contact 1 patient from each group in order to schedule follow-up"|||units on a scale||Standard Deviation|Mean
1409803|NCT01183260|Primary|Periprosthetic Bone Mineral Density (BMD) of Hip|Quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.|2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative|"By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group:~We were unable to contact 1 patient from each group in order to schedule follow-up The remaining patients were withdrawn because they were feeling fine and declined to return for follow-up at that time"|||g/cm^2||Standard Deviation|Mean
1409804|NCT01183234|Primary|Time of Maximum Plasma Concentration (Tmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set|||hours||Full Range|Median
1409805|NCT01183234|Primary|Maximum Plasma Concentration (Cmax) for MPH Using Two Different Formulations (Equasym XL and Metadate CD)|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|PK set|||ng/ml||90% Confidence Interval|Least Squares Mean
1409806|NCT01183234|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC 0-t) for Methylphenidate Hydrochloride (MPH) Using Two Different Formulations (Equasym XL and Metadate CD)|AUC 0-t is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|predose and 0.5, 1.0, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours post-dose|Pharmacokinetic analysis set (PK) defined as all subjects in the safety analysis set who had evaluable plasma concentration-time profiles for MPH through 24 hours post-dosing in both treatment periods. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded.|||ng*h/ml||90% Confidence Interval|Least Squares Mean
1409807|NCT01183169|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.|within 24 weeks after treatment|FAS For Efficacy|||percentage of participants|||Number
1409808|NCT01183169|Secondary|Percentage of Participants With On-treatment Viral Breakthrough|"On-treatment viral breakthrough was defined as either:~Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or~HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOQ) during treatment"|within 48 weeks|FAS For Efficacy|||percentage of participants|||Number
1409809|NCT01183169|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End||Up to 48 weeks|Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point|||percentage of participants|||Number
1409810|NCT01183169|Secondary|Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD|ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.|within 48 weeks|FAS For Efficacy|||percentage of participants|||Number
1409811|NCT01183169|Secondary|Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD|pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy|||percentage of participants|||Number
1409812|NCT01183169|Secondary|Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD|RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.|after 4 weeks of treatment|FAS For Efficacy|||percentage of participants|||Number
1409813|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD|SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.|24 weeks after treatment|FAS For Efficacy|||percentage of participants|||Number
1409814|NCT01183169|Secondary|Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD|SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.|12 weeks after treatment|FAS For Efficacy|||percentage of participants|||Number
1409815|NCT01183169|Secondary|Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)|cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|FAS For Efficacy|||percentage of participants|||Number
1409816|NCT01183169|Primary|Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)|cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.|after 12 weeks of treatment|Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment|||percentage of participants|||Number
1409817|NCT01183143|Secondary|Number of Subjects Taking at Least 1 Concomitant Treatment||Up to 1 year|The tolerance analysis set included of all the subjects who were presented at the inclusion visit.|||subjects|||Number
1409818|NCT01183143|Secondary|Number of Subjects With at Least 1 Adverse Event|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerged or worsened relative to baseline (i.e. present at the initial study visit) during a clinical study with an investigational product, regardless of causal relationship and even if no investigational product has been administered.|Up to 1 year|The tolerance analysis set included of all the subjects who were presented at the inclusion visit.|||subjects|||Number
1409819|NCT01183143|Secondary|Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator|Local tolerance at the GONAL-f ® injection site was assessed for the presence of pain, swelling/welt, redness, itch and haematoma.|Up to 1 year|ITT population included all the subjects who received at least 1 dose of the investigational medicinal product.|||subjects|||Number
1409820|NCT01183143|Secondary|Number of Subjects With Live Birth|Number of subjects whose stimulation with the IMP resulted in the birth of a baby were reported.|End of Gestation period, assessed up to a maximum of 1 year|Per Protocol (PP) population was defined as the group of subjects who completed the study, having returned their completed questionnaire and who did not present any major protocol deviations.|||subjects|||Number
1409821|NCT01183143|Secondary|Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI)|Pregnancy rate was defined as the percentage of subjects with diagnosis of pregnancy, who underwent OI/IUI. Clinical pregnancy: Evidence of pregnancy by clinical or ultrasound parameters at 12 weeks after fertilization. Biochemical pregnancy: Evidence of conception based only on biochemical data in the serum or urine before ultrasound evidence of a gestational sac. Ongoing pregnancy was defined when the pregnancy had completed 20 weeks of gestation.|Up to 20 Weeks of Gestation|"The ITT population included all the subjects who received, at least 1 dose of the IMP. Number of Participants Analyzed signifies ITT (OI/IUI) subjects who were evaluable for this outcome measure."|||Percentage of subjects||95% Confidence Interval|Number
1423330|NCT01070784|Primary|Vital Signs- Sitting Diastolic Blood Pressure(DBP)|Change from baseline|Baseline and 52 week after||||mmHg||Standard Deviation|Mean
1409826|NCT01183143|Secondary|Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator|Investigator evaluated the use of GONAL-f® prefilled pen in subjects as very satisfactory, satisfactory and average satisfaction.|Up to 1 year|"The ITT population included all the subjects who received at least 1 dose of the IMP. Here Overall Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome."|||subjects|||Number
1409827|NCT01183143|Primary|Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)|Number of subjects who self-administered the IMP were presented in this outcome measure.|Up to 1 year|The ITT population included all the subjects who received at least 1 dose of the IMP.|||subjects|||Number
1409828|NCT01183104|Secondary|Change From Baseline in Body Weight at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.|||kg||Standard Deviation|Mean
1409829|NCT01183104|Secondary|Change From Baseline in Insulin/Proinsulin Ratio at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.|||ratio||Standard Deviation|Mean
1409830|NCT01183104|Secondary|Change From Baseline in HOMA-β at 52 W|β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]|Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.|||percent||Standard Deviation|Mean
1409831|NCT01183104|Secondary|The Number of Participants Achieving HbA1c < 6.9 %||52 W|Analysis set of evaluation for efficacy; Per Protocol Set Some participants were not completed to 52 W.|||Participants|||Count of Participants
1409832|NCT01183104|Primary|Number of Participants With Hypoglycaemia||From baseline to 52 W|Analysis set of evaluation for safety.|||Participants|||Count of Participants
1409833|NCT01183104|Primary|Change From Baseline in HbA1c at 52 W||Baseline and 52 W|Analysis set of evaluation for efficacy; Per Protocol Set.|||percent||95% Confidence Interval|Least Squares Mean
1409834|NCT01183065|Primary|To Determine the Overall Response Rate (CR+PR)|by RECIST version 1.1 criteria|2 years||||participants|||Number
1409835|NCT01183013|Secondary|Incidence of Rescue Therapy During the First 30 Weeks of Treatment|Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.|30 weeks|FAS|||participants|||Number
1409836|NCT01183013|Secondary|Time to First Use of Rescue Therapy|Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.|30 weeks|FAS|||Proportion of participants|||Number
1409837|NCT01183013|Secondary|Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)|The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.|Baseline and 30 weeks|MTT set: This patient set includes those patients in the FAS who had a valid MTT at baseline and at least one valid on-treatment MTT. An MTT is considered valid if both an FPG and a 2-hour PPG value are available.|||mg/dL||Standard Error|Least Squares Mean
1409838|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)|||mg/dL||Standard Error|Mean
1409839|NCT01183013|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment|The change from baseline is the FPG after 30 weeks minus the baseline FPG.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with a value for FPG at baseline and on-treatment. Last observation carried forward (LOCF) used to handle missing values at Week 30.|||mg/dL||Standard Error|Mean
1409840|NCT01183013|Secondary|HbA1c Change From Baseline by Visit Over Time|"HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.~by visit interaction."|Baseline, week 6, week 12, week 18, week 24, week 30|FAS (observed cases)|||percent||Standard Error|Mean
1409841|NCT01183013|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS with non-completers (without a value at Week 30) considered as failure|||participants|||Number
1409842|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c >=6.5%. Non-completers (patients without a value at Week 30) were considered as failures (NCF)|||participants|||Number
1409843|NCT01183013|Secondary|Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.|Baseline and 30 weeks|FAS patients who also had baseline HbA1c>=7%.Non-completers (patients without a value at Week 30) were considered as failures (NCF).|||participants|||Number
1409844|NCT01183013|Primary|Change From Baseline in HbA1c After 30 Weeks of Treatment.|HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.|Baseline and 30 weeks|Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c.|||percent||Standard Error|Mean
1409845|NCT01182805|Primary|Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler|E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.|Assessed from echo obtained at time of enrollment|Only 25 subjects had adequate images for assessment of DCSR-IVR and interpretable tissue Doppler and gold standard assessment of diastolic function, and the analysis was limited to these subjects.|||cm/sec||Standard Deviation|Mean
1409879|NCT01182428|Secondary|In-segment Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||% diameter stenosis|Participants|Standard Deviation|Mean
1409846|NCT01182805|Primary|Diastolic Circumferential Strain Rate During Isovolumic Relaxation|Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.|Assessed from echo obtained at time of enrollment|Only 26 subjects had adequate images for assessment of DCSR-IVR and had gold standard assessment of diastolic function, and the analysis was limited to these subjects.|||1/sec||Standard Deviation|Mean
1409847|NCT01182727|Primary|Side Effects of Salsalate|This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects.|6 weeks|All subjects who completed the study were analyzed.|||participants|||Number
1409848|NCT01182675|Secondary|Number of Patients Who Achieve Engraftment of Donor T-cells in Blood by STR Testing|We will measure whether we are able to detect donor T-cells in the patient's blood after HSCT.|1 Year|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
1409849|NCT01182675|Secondary|Number of Patients With Engraftment of Donor Stem Cells in Bone Marrow by STR Testing|We will measure whether we are able to detect donor stem cells in the patient's bone marrow after HSCT.|1 Year|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
1409850|NCT01182675|Secondary|Percentage of Patients Who Become Independent From Regular IVIG Infusion|Based on B-cell function assays from the patient's blood, we will be able to determine if patients are able to successfully discontinue IVIG infusions.|2 Years|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
1409851|NCT01182675|Secondary|Incidence of Chronic GVHD||2 Years|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||Participants|||Count of Participants
1409852|NCT01182675|Secondary|Incidence of Acute GVHD||100 Days|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||participants|||Number
1409853|NCT01182675|Primary|Engraftment of Donor B-cells in Blood by STR Testing|Number of participants in whom donor B cells were detected in the patient's blood after HSCT.|1 Year|No patients with T-cell Graft Resistant SCID were enrolled during the time the trial was open.|||participants|||Number
1409854|NCT01182610|Secondary|Survival||2-year survival from first dose of panitumumab|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
1409855|NCT01182610|Secondary|Thirty-day Surgical Mortality|All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.|From date of surgery to 30 days after date of surgery|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
1409856|NCT01182610|Secondary|Resection Rate of Surgery|"The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H&E)examination, and the operative report indicates complete resection with no residual disease.~The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H&E) examination, and the operative report indicates complete resection with no residual disease.~The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease."|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
1409857|NCT01182610|Secondary|Pathologic Response Rate|The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H&E) examination.|At time of surgery (between days 50 to 64)|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
1409858|NCT01182610|Primary|Response Rate|The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.|From the start of study treatment until restaging evaluation performed between days 36 to 43|This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.||||||
1409859|NCT01182493|Secondary|Safety - Diabetic Ketoacidosis Incidence|Diabetic Ketoacidosis incidence during the study|6 Months||||Participants|||Count of Participants
1409860|NCT01182493|Secondary|Change in Body Weight|Change in body weight from randomization to the end of study. Change in body weight = weight at 6 month - weight at baseline, among subjects with available body weight|6 months||||kg||Standard Deviation|Mean
1409880|NCT01182428|Secondary|In-stent Percent Diameter Stenosis||at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||% diameter stenosis|Participants|Standard Deviation|Mean
1409861|NCT01182493|Secondary|Quality of Life and Treatment Satisfaction - Results From Diabetes Treatment Satisfaction Questionnaire (DTSQ)|Subjects were asked to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQs). Treatment satisfaction is measured by means of the DTSQs, status version (DTSQs, Bradley, 1990). It consists of a six-item scale assessing treatment satisfaction (TS) and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQs items are scored on a scale from 0 to 6. The scale total is computed by adding the six items 1, 4, 5, 6, 7, and 8, to produce the Treatment Satisfaction scale total, which has a min of 0 and a max of 36. Higher score at 6 month compared to baseline represents a better outcome. Change in treatment satisfaction = score at 6 month - score at baseline, among subjects with available satisfaction scores|6 months||||score||Standard Deviation|Mean
1409862|NCT01182493|Secondary|Change in Glycemic Variability - AUC in Hyper (≥180mg/dL)|Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hyper- (≥180mg/dL), among subjects with available AUC results. Change in hyper AUC = hyper AUC at 6 month - hyper AUC at baseline|6 months||||mg/dL/min||Standard Deviation|Mean
1409863|NCT01182493|Secondary|Safety - Severe Hypoglycemia Incidence|Severe hypoglycemia incidence during the study|6 months||||Participants|||Count of Participants
1409864|NCT01182493|Secondary|Change in Glycemic Variability - AUC in Hypo (≤70mg/dL)|Glycemic parameters calculated from blinded CGM data: change in AUC (Area Under the Curve) in hypo- (≤70mg/dL), among subjects with available AUC results. Change in hypo AUC = hypo AUC at 6 month - hypo AUC at baseline|6 months||||mg/dL/min||Standard Deviation|Mean
1409865|NCT01182493|Primary|Between Group Difference in HbA1c When Comparing CSII to MDI|To evaluate change in glycemic control (HbA1c) after 6 months of insulin pump therapy in patients with type 2 DM, as compared to patients on MDI therapy over the same time period. Change in A1c = A1c at 6 month - A1c at baseline|baseline and 6 months||||Change in % HbA1c||Standard Deviation|Mean
1409866|NCT01182480|Secondary|Glycemic Control|Measured by patients' self-reported fasting blood glucose levels during the intervention period and compared to previous laboratory data in the medical record.|3 months|||||||
1409867|NCT01182480|Secondary|Perceived Self-efficacy|As measured by comparison of patient responses to validated assessment instrument administered at baseline and post-intervention|3 months|||||||
1409868|NCT01182480|Secondary|Appointment Attendance|As measured by no-show rates for appointments at all clinics during the study period, compared between intervention and control groups|3 months|||||||
1409869|NCT01182480|Primary|Patient Engagement|Patient engagement was assessed by patient text message response rates and average response times. Response rates were calculated as a percentage from the number of patient-initiated text messages sent in response to a system-generated request for information (the numerator) divided by the total number of system-generated requests for information (the denominator). Average response times were calculated from system-recorded time stamps for outbound requests sent and inbound patient-initiated responses received.|3 months|Group of study participants who received the text message intervention over a 3-month period.|||text message response rate (percent)|||Number
1409870|NCT01182441|Primary|Composite of Ischemic Stroke or Systemic Embolism|Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization|Day 8 to 18-months||||Probability of events within 18-months|||Number
1409871|NCT01182441|Primary|Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown)|The endpoint was analyzed using a Bayesian piecewise exponential model with the historical priors based on data from the previous pivotal study PROTECT AF. This was a non-inferiority design with comparison of rate ratio of 18-month event rates of the Device and Control groups. The 18-month rate represents the probability of an event occurring within 18 months, and the 18-month rate ratio is a mean of the rate ratios. The primary endpoint was based on a calculation of the probability of events at 18 months but the statistical piecewise hazards model does not require the observation of any subjects out to 18-months.|18 month rate||||Probability of events within 18 months|||Number
1409872|NCT01182441|Primary|Primary Safety Endpoint (Device Group Only)|7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.|7-Day||||Participants|||Count of Participants
1409873|NCT01182428|Secondary|Persisting Dissection|All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
1409874|NCT01182428|Secondary|Thrombus|All subjects with thrombus of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
1409875|NCT01182428|Secondary|Aneurysm|All subjects with aneurysm of the target lesion up to the 270 day follow-up visit|at 270 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||% of target lesions with aneurysm|Participants|95% Confidence Interval|Number
1409876|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409877|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409878|NCT01182428|Secondary|Adjudicated Revascularization (TLR/TVR/All Revascularizations)|Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations|at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409881|NCT01182428|Secondary|In-segment Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||Percentage of target lesions|Participants|95% Confidence Interval|Number
1409882|NCT01182428|Secondary|In-stent Angiographic Binary Restenosis Rates|Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).|at 270 days|The angiographic analysis population is less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||Percentage of Target Lesions|Participants|95% Confidence Interval|Number
1409883|NCT01182428|Secondary|In-segment Late Loss (LL)|LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up|at 270 days|The angiographic analysis population may be less than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||millimeters|Participants|Standard Deviation|Mean
1409884|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409885|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409886|NCT01182428|Secondary|Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409887|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409888|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409889|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409890|NCT01182428|Primary|In-stent Late Loss (LL) (Main Secondary Endpoint)|In-stent Minimal Lumen Diameter (MLD)post-procedure – in-stent MLD at follow-up.|at 270 days|The angiographic analysis population may be than the total population for the following reasons: Refusals, Death, Test Not Analyzable, Scheduling Problems, Medical Decisions, No study stent implanted, Patient Misunderstandings, Patient withdrawn by physician, Consent Withdrawal.|||millimeters|Participants|Standard Deviation|Mean
1409891|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409892|NCT01182428|Secondary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409893|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409894|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.||at 240 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409895|NCT01182428|Secondary|Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).||at 30 days|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409896|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable, Possible)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
1409897|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||30 days to 1 year (Late)|Based on Intent to Treat (ITT) population. Population change based on follow up timeframe.|||Percentage of Participants||95% Confidence Interval|Number
1409898|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||1 to 30 days (Sub-Acute)|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
1409899|NCT01182428|Secondary|Adjudicated Stent Thrombosis (Definite, Probable)||< 1 day (Acute)|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
1409900|NCT01182428|Secondary|Clinical Procedure Success|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.|Intra-operative|Based on Intent to Treat (ITT) population.|||Percentage of Participants||95% Confidence Interval|Number
1409901|NCT01182428|Secondary|Clinical Device Success|Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.|Intra-operative|Based on Intent to Treat (ITT) population.|||Percentage of evaluated lesions|Participants|95% Confidence Interval|Number
1409902|NCT01182428|Primary|Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).|This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.|at 1 year|Based on Intent to Treat (ITT) population. The analysis population at follow-up visits may have changed due to early termination from the study by the patient or physician.|||Percentage of Participants||95% Confidence Interval|Number
1409903|NCT01182415|Secondary|Response Rate|The number of participants that achieved complete remission following high dose chemotherapy and autologous stem cell transplantation (ASCT). Complete remission is defined as the disappearance of all evidence of disease.|3 years|The participant that was lost to follow-up was not available for analysis.|||Participants|||Count of Participants
1409904|NCT01182415|Secondary|2-year Overall Survival (OS)|The percentage of participants alive after two years|2 years|The participant that was lost to follow-up was not available for analysis.|||percentage of participants||95% Confidence Interval|Number
1409905|NCT01182415|Secondary|2-year Progression Free Survival (PFS)|The percentage of participants alive and without disease progression at 2 years.|2 years|The participant that was lost to follow-up was not available for analysis.|||percentage of participants||95% Confidence Interval|Number
1409906|NCT01182415|Primary|Proportion of Patients With CNS Involvement by B-cell NHL, Relapsed PCNSL, or Relapsed PIOL Who Are Alive and Progression-free at One Year|The proportion of patients with central nervous system (CNS) involvement by B-cell Non-Hodgkin's Lymphoma (NHL), relapsed primary central nervous system lymphoma (PCNSL), or relapsed primary intraocular lymphoma (PIOL) who are alive and progression-free at one year|3 years|The participant that was lost to follow-up was not available for analysis.|||Participants|||Count of Participants
1409907|NCT01182376|Primary|LA Fibrosis|The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.|baseline, 1 year|The number of participants analyzed for both groups is less than the number enrolled due to patient attrition or poor MRI scans.|||percentage of fibrosis||Standard Deviation|Mean
1409908|NCT01182337|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|"FAS Population~Only 21 subjects from the rhGDF-5 group (out of 22 subjects total) completed the MCS, SF-36."|||units on a scale||Standard Deviation|Mean
1409909|NCT01182337|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 months|"FAS Population~Only 21 subjects from the rhGDF-5 group (out of 22 total subjects) completed the baseline PCS, SF-36."|||units on a scale||Standard Deviation|Mean
1409910|NCT01182337|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
1409911|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
1409912|NCT01182337|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
1409913|NCT01182337|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 month|FAS Population|||units on a scale||Standard Deviation|Mean
1409914|NCT01182337|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~For the Neurological Assessment at 12 months, only 21 subjects from the rhGDF-5 group completed the assessment (out of 22 total subjects) and 5 subjects from the Control group completed the assessment (out of 9 subjects total)."|||participants|||Number
1409915|NCT01182298|Primary|Median Log Change in HCV RNA Levels on Day 7|The primary end point of this study is the the log change in HCV RNA levels on Day 7|first 7 days||||log IU/mL||Inter-Quartile Range|Median
1409916|NCT01182285|Secondary|NIS (Na/I-symporter) Expression|NIS (Na/I-symporter) Expression is assessed by quantitative reverse transcription (RT) polymerase chain reaction (PCR) and immunohistochemistry (IHC). NIS mRNA expression was measured by quantitative RT PCR from biopsy samples.|Entry to study and after 10 weeks of treatment|There is no standard of error to report. The acronym GAPDH expanded is glyceraldehyde 3-phosphate dehydrogenase. Only 1 participant was analyzed because biopsies were not performed in 12 subjects.|||percent expression||Standard Error|Median
1409917|NCT01182285|Secondary|Best Overall Response|Best overall response was assessed by radioiodine uptake. Complete response (CR) is increased Rai (radioiodine) uptake on post- valproic acid therapy at week 10, AND a decrease in Tg (thyroglobulin ) level to less than 2 ng/ml (or a decrease in Tg-Ab (thyroglobulin antibodies) level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Week 16|Best overall response was not assessed for the phase 1 portion.|||Participants|||Count of Participants
1409918|NCT01182285|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 41 months and 11 days|Adverse events are not reported per Arm. All adverse events were reported to include phases 1 and 2 since it is analyzed throughout the whole study.|||Participants|||Count of Participants
1409919|NCT01182285|Primary|RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment|Complete response (CR) is increased Rai uptake on post- valproic acid therapy at week 10, AND a decrease in Tg level to less than 2 ng/ml (or a decrease in Tg-Ab level to less than 2.0 IU/ml) at 10 weeks AND disappearance of all lesions at 16 weeks. Partial response (PR) is increased Rai uptake on post-valproic scan at week 10, OR a decreased Tg level (or a decrease in Tg Ab (Tg antibody) level by more than 20%) at 10 weeks AND 30% decrease in target lesion at 16 weeks. Stable disease (SD) is no change in RAI uptake AND Tg levels (or TG-Ab level) AND no significant change of lesions at 16 weeks. Progressive disease (PD) is tumor mass increases OR Tg levels (or Tg-Ab levels) increases over 10 weeks OR at least 20% increase in target lesion at 16 weeks.|Entry to study and after 10 weeks of treatment for Phase 1, and 10 weeks of treatment to 16 weeks of treatment for phase 2.|13 participants were enrolled in phase 1 and 8/13 (5 from University of California San Francisco (UCSF) moved on from phase 1 to the phase 2 schedule 2 portion. However, Tg data from UCSF is unavailable for 5 of the participant, thus only 3 were analyzed in the phase 2 portion.|||Participants|||Count of Participants
1409920|NCT01182207|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409921|NCT01182207|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409922|NCT01182207|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1409923|NCT01182207|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1409924|NCT01182207|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1409925|NCT01182207|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1409926|NCT01182194|Primary|AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Ethinyl Estradiol AUC0-inf.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||pg*h/mL||Standard Deviation|Mean
1409927|NCT01182194|Primary|AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Ethinyl Estradiol AUC0-t.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||pg*h/mL||Standard Deviation|Mean
1409928|NCT01182194|Primary|Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Ethinyl Estradiol Cmax.|Blood samples collected over a 72 hour period.|Analysis included 29 of 31 finished subjects. Subject 13 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1 and Period 2. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||pg/mL||Standard Deviation|Mean
1409929|NCT01182194|Primary|AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Drospirenone AUC0-inf.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||ng*h/mL||Standard Deviation|Mean
1409930|NCT01182194|Primary|AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Drospirenone AUC0-t.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||ng*h/mL||Standard Deviation|Mean
1409931|NCT01182194|Primary|Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Drospirenone Cmax.|Blood samples collected over a 120 hour period.|Analysis included 30 of 31 finished subjects. Subject 31 was excluded from the analysis population due to pre-dose levels greater than 5% for Cmax in Period 1.|||ng/mL||Standard Deviation|Mean
1409932|NCT01182181|Primary|AUC0-t of Anastrozole(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Anastrozole AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1409933|NCT01182181|Primary|Cmax of Anastrozole(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Anastrozole Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1409934|NCT01182103|Secondary|BDNF Levels of MDD Patients Before and After Treatment and Healthy Controls|"Serum BDNF levels were measured. MDD patients received antidepressant treatment, a standard biological management. Nothing novel (such as experimental drugs or management) is introduced in the treatment, so the research design is observational (of standard treatment).~The choice of antidepressant drugs depended on the need of patients in natural treatment procedure. They included selective serotonin reuptake inhibitors (SSRI), eg. fluoxetine or paroxetine."|2 years||||ng/ml||Standard Deviation|Mean
1409935|NCT01182103|Primary|Histone Modification of MDD Patients Before and After Treatment and With Healthy Controls|"Chromatin immunoprecipitation (ChIP) was used to measure histone modification. The unit of our given machine is relative quantification, and a higher value indicated increased histone modification. The detailed method could be found in:~Huebert DJ, Kamal M, O’Donovan A, Bernstein BE: Genome-wide analysis of histone modifications by ChIP-on-chip. Methods 2006; 40: 365–369."|2 years||||relative quantification||Standard Deviation|Mean
1409936|NCT01182103|Primary|Brain-derived Neurotrophic Factor (BDNF) DNA Methylation of Major Depressive Disorder (MDD) Patients and Healthy Controls|averaged percentage of methylation at each CpG site listed|2 years|Only 39 out of the 48 MDD patients provided enough blood sample for this analysis.|||percent||Standard Deviation|Mean
1409937|NCT01181986|Secondary|Plasma Glucose|Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6, and 8 hours post-study drug on day 11||||mg/dl||Standard Error|Least Squares Mean
1409938|NCT01181986|Secondary|Plasma Triglycerides|Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.|0, 2, 4, 6 and 8 hours post-study drug on day 11||||mg/dl||Standard Error|Least Squares Mean
1409939|NCT01181986|Primary|Reactive Hyperemia Index (RHI)|Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.|0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)||||ratio||Standard Error|Least Squares Mean
1409940|NCT01181947|Primary|Technical Success at Time of Initial Implant|Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system|intraoperatively|"The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."|||participants||95% Confidence Interval|Number
1409941|NCT01181947|Secondary|ACM and ARM|All-cause (ACM), Aneurysm related (ARM) and dissection related mortality|at 30 days, 12 months, 24 months and 36 months|||||||
1409942|NCT01181947|Secondary|SAE|Serious Adverse Events (SAE)|through 12 months|"The primary and secondary endpoints will be reported descriptively.~By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses."|||participants||95% Confidence Interval|Number
1409943|NCT01181947|Primary|Treatment Success|"technical success and freedom from~TAA diameter increase of stented segment (>5mm compared to 1 mo),~Types I/III endoleak,~Aneurysm rupture,~Conversion to open surgery,~Stent graft occlusion,~Stent graft migration resulting in SAE or secondary intervention."|at 30 days, 12 months, 24 months and 36 months|||||||
1409944|NCT01181921|Primary|Change From Baseline in Sleep/Wake Patterns as Measured by Actigraph at 12 Weeks|Actigraph is a small portable device that is worn on the wrist of the non-dominant arm to measure body movement during long time periods. It creates a pattern based on activity that is useful in assessing sleep-wake cycles across many consecutive days and nights. It is useful for assessing sleep phase disorders.|Baseline and 12 weeks|Only one participant was recruited and did not complete the study; therefore no assessments have been conducted throughout the study.||||||
1409945|NCT01181895|Secondary|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at the End of Week 4 and Week 12|At the end of Week 4 and Week 12, the Global Assessment of Change Questionnaire, which assesses changes in asthma symptoms and rescue medication use, was completed by participants using the following scale: asthma symptom (AS) change: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse; rescue medication use (RMU): much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often.|Week 4 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.|||Participants|||Number
1410352|NCT01178294|Secondary|PK Analysis- Volume of Distribution (Vd) at Steady State|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population|||U/percent activity||Standard Deviation|Mean
1409946|NCT01181895|Secondary|Number of Participants With the Indicated Time to an Increase of >=12% and >=200 Milliliters (mL) Above Baseline in FEV1 on Day 1 and Day 84 (0-2 Hours)|The number of participants with a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated on Day 1 and Week 12 for the time to a >=12% increase from Baseline (at the 5 minutes (min), 15 min, 30 min, 1hour (hr), and 2 hr nominal time points. Participants who did not achieve a >=12% and >=200 mL increase from Baseline in FEV1 over this time period were considered censored.|Day 1 and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.|||Participants|||Number
1409947|NCT01181895|Secondary|Change From Baseline in Daily AM (Morning) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily AM PEF prior to randomization. Change from Baseline in trough AM PEF was calculated as the averaged value of all daily AM PEF for Weeks 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters per minute (L/min)||Standard Error|Least Squares Mean
1409948|NCT01181895|Secondary|Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) PM (Evening) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. The Baseline value is the average value of the last 7 days of daily PM PEF prior to randomization. Change from Baseline in trough PM PEF was calculated as the averaged value of all daily PM PEF for Week 1 to Week 12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters per minute (L/min)||Standard Error|Least Squares Mean
1409949|NCT01181895|Secondary|Change From Baseline in Individual Serial FEV1 Assessments at the End of the 12-week Treatment Period, Including the 12-hour and 24-hour Time Points|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The individual serial FEV1 is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 3, 5, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, relatively, on Treatment Day 84 (Week 12). The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline was calculated as the value of the individual serial FEV1 taken at Week 12 minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment. Analysis was performed separately for each planned time point.|Baseline and Week 12|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
1409950|NCT01181895|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Participants who were symptom free for 24-hour periods during the12-week treatment period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1409951|NCT01181895|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The time span during which the participants did not have to take any rescue bronchodilator (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant (including the day of randomization). Change from Baseline is calculated as the value at Weeks 1-12 minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time points were assessed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1409952|NCT01181895|Primary|Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1409953|NCT01181804|Primary|t1/2 Boceprevir in Fasted State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||hours||Standard Deviation|Mean
1409954|NCT01181804|Primary|Half Life (t1/2) of Boceprevir in Fed State|T1/2 is the time required for a given drug concentration to decrease by 50%.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||hours||Standard Deviation|Mean
1409955|NCT01181804|Primary|AUCinf in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
1410366|NCT01178281|Secondary|Frequency of Adverse Events|An Adverse Event (AE) is any noxious, unintended or untoward medical occurrence that may appear or worsen in a participant during the course of a study.|Up to 2.5 years||2018-08-31|08/2018||||
1409956|NCT01181804|Primary|AUC From Hour 0 to Infinity (AUCinf) in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
1409957|NCT01181804|Primary|Cmax of Boceprevir Tablets Versus Capsules in Fasted State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng/mL||90% Confidence Interval|Geometric Mean
1409958|NCT01181804|Primary|AUCtf for Boceprevir Tablets Versus Capsules in Fasted State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
1409959|NCT01181804|Primary|Maximum Plasma Concentration (Cmax) of Boceprevir Tablets Versus Capsules in Fed State|Cmax is the highest plasma drug concentration observed on the plasma concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
1409960|NCT01181804|Primary|Area Under the Concentration Curve (AUC) From Hour 0 to the Final Quantifiable Sample (AUCtf) for Boceprevir Tablets Versus Capsules in Fed State|AUC is the measure of total plasma exposure of a drug over a given time period. AUC is derived from the area under the plasma drug concentration-time curve.|Predose through 72 hours post-dose|Analysis is per protocol; all available data are included in the model. No imputation is used for missing data.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
1409961|NCT01181778|Secondary|Percentage of Participants With Post-counseling Contacts With Physician Offices, by Hormonal Contraceptive Method|Participant contacts with physician offices were collected, and the number of callbacks by method of contraception recorded. Participants who called back more than once were counted overall and for each method of contraception.|Up to four months after the counseling visit|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.|||percentage of participants|||Number
1409962|NCT01181778|Primary|Number of Participants Choosing Each Hormonal Contraceptive Method Before and After Counseling|Before receiving counseling, participants recorded on a questionnaire the method of contraception they thought they would choose. This was to be compared with the method of contraception the same participants thought they would choose after they received physician counseling, which was also recorded on their questionnaire.|Day of inclusion (Day 0) prior to physician counseling and after physician counseling|The analysis population consisted of all participants who completed questionnaires before and after physician counseling and had no medical reason to prevent them from using a combined hormonal contraception method.|||Participants|||Number
1409963|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409964|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409965|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1409966|NCT01181726|Secondary|AUC0-inf of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409967|NCT01181726|Secondary|AUC0-t of Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409968|NCT01181726|Secondary|Cmax of Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1409969|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409970|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409971|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1409972|NCT01181726|Secondary|AUC0-inf of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409973|NCT01181726|Secondary|AUC0-t of Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409974|NCT01181726|Secondary|Cmax of Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1409975|NCT01181726|Secondary|AUC0-inf of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409976|NCT01181726|Secondary|AUC0-t of Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409977|NCT01181726|Secondary|Cmax of Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1409978|NCT01181726|Primary|AUC0-inf of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409979|NCT01181726|Primary|AUC0-t of Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1409980|NCT01181726|Primary|Cmax of Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1409981|NCT01181726|Primary|AUC0-inf of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1409982|NCT01181726|Primary|AUC0-t of Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1409983|NCT01181726|Primary|Cmax of Norethindrone (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1409984|NCT01181609|Secondary|OS - Time to Event|OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method.|Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)|ITT population|||months||95% Confidence Interval|Median
1409985|NCT01181609|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|Overall survival was defined as the time from start of study treatment to death from any cause.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population|||percentage of participants|||Number
1409986|NCT01181609|Secondary|Duration of Overall Disease Control|ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method.|Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)|ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis.|||months||95% Confidence Interval|Median
1409987|NCT01181609|Secondary|Duration of Response|Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method.|Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)|ITT population; only participants with a response (CR or PR) were included in the analysis.|||months||95% Confidence Interval|Median
1409988|NCT01181609|Secondary|PFS - Time to Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population|||months||95% Confidence Interval|Median
1409989|NCT01181609|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT|||percentage of participants|||Number
1409990|NCT01181609|Secondary|Percentage of Participants Achieving a Best Overall Response of CR or PR|Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)|ITT population|||percentage of participants||95% Confidence Interval|Number
1409991|NCT01181609|Primary|Percentage of Participants Achieving Overall Disease Control (ODC)|ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met.|Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)|ITT population|||percentage of participants||95% Confidence Interval|Number
1409992|NCT01181531|Secondary|Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)|week 40-52||||Participants|||Number
1409993|NCT01181531|Secondary|Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)|Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Baseline to week 40-52||||Participants|||Number
1409994|NCT01181531|Primary|Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)|Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52|Baseline to week 40-52|All subjects randomized by treatment arm.|||Percent change||Standard Error|Least Squares Mean
1409995|NCT01181492|Secondary|PCA Fentanyl Consumption|PCA fentanyl consumption and adverse effects are recorded during the first 24 h after surgery.|24 h after surgery||||μg||Standard Deviation|Mean
1409996|NCT01181492|Secondary|The Visual Analog Scale 24 Hours Postoperative|The visual analog scale (VAS) is used for pain evaluation at rest which from 0 to 10 (higher values represent morepain) during patient-controlled analgesia (PCA) treatment 24 h after operation|24 hours after operation||||units on a scale||Standard Deviation|Mean
1409997|NCT01181492|Primary|CYP3A4*1G Polymorphism|According to CYP3A4*1G polymorphism,patients are devided into three groups: *1/*1,*1/*1G,*1G/*1G|48 hours after operation|the number of participants for analysis was determined according to gene type of CYP3A4*1G polymorphism which was carried by participant.|||participants|||Number
1409998|NCT01181479|Other Pre-specified|Self-reported Itching at Patch Application Site|"Evaluation of itching at patch application site was determined using the following scores:~0: None~Mild~Moderate~Severe"|1 year|Safety Population|||Score on a scale||Standard Deviation|Mean
1409999|NCT01181479|Other Pre-specified|Patch Adhesion by Investigator Evaluation at Each Visit|"Evaluation of patch adhesion was determined using the following scores:~0: >= 90% adhered (no lift)~>= 75% adhered but < 90% (some edges showing lift)~>= 50% adhered but < 75% (half of system lifts off)~< 50% (> half of system lifts off, but undetached)~patch completely detached"|1 year|Safety Population|||Score on a scale||Standard Deviation|Mean
1410000|NCT01181479|Other Pre-specified|Self-reported Irritation at Application Site|"Evaluation of irritation at application site was determined using the following scores:~0: None~Mild~Moderate~Severe"|1 year|Safety Population|||Score on scale||Standard Deviation|Mean
1410001|NCT01181479|Other Pre-specified|Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)|Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.|Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months|Subjects that received contraceptive and were analyzed for LNG and EE.|||pg/ml||95% Confidence Interval|Mean
1410002|NCT01181479|Other Pre-specified|Cycle Control|Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.|6 months|Number of subjects with documented cycle information.|||percentage of cycles with BTB/BTS|||Number
1410003|NCT01181479|Primary|Pregnancy|Pregnancy outcomes was determine by measuring Pearl index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year|Subjects in the Safety population, age 17-35 with a BMI <32, were analyzed.|||Pearl Index||95% Confidence Interval|Number
1410004|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events||From end of surgery through hospital discharge, an expected average of 6 days|FAS population includes all treated participants|||participants|||Number
1410005|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents|Neuromuscular blockade reversal agents administered to participants undergoing surgical procedures were recorded. The number of participants who received such an agent is presented, for participants with and without residual neuromuscular blockade.|From end of surgery through PACU arrival, an expected average of 10 minutes|FAS population includes all treated participants|||participants|||Number
1410006|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane|Anesthetic agents administered to participants undergoing surgical procedures were recorded. The number of participants who received propofol or sevoflurane is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received propofol or sevoflurane are included|||participants|||Number
1410007|NCT01181349|Secondary|Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents|Neuromuscular blocking agents administered to participants undergoing surgical procedures were recorded. The number of participants who received atracurium, cisatracurium, rocuronium or vecuronium is presented, for participants with and without residual neuromuscular blockade.|From start of surgery through PACU arrival|FAS population includes all treated participants; for this outcome measure only participants who received atracurium, cisatracurium, rocuronium or vecuronium are included|||participants|||Number
1410367|NCT01178281|Secondary|FACT-Anemia Quality of Life Questionaire|The FACT-An questionnaire is a cancer-specific questionnaire measuring the four general domains of quality-of-life and an additional anemia questionnaire.|Up to treatment discontinuation||2018-08-31|08/2018||||
1410008|NCT01181349|Primary|Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival|The incidence of incomplete postoperative neuromuscular recovery from general anesthesia was assessed in study participants upon arrival in the PACU, after their respective surgical procedures were completed. Neuromuscular functioning was assessed by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The TOF ratio is the ratio of the magnitude of the fourth twitch to that of the first twitch, and a ratio <0.9 indicates residual neuromuscular blockade (incomplete neuromuscular recovery).|Upon arrival in the PACU|Full analysis set (FAS) population includes all treated participants|||participants|||Number
1410009|NCT01181323|Secondary|ELISA IgA and IgG GMT to Each of the Influenza Strains in the Vaccine Received in Sera of Maternal Subjects|Blood was collected from maternal subjects on Day 0 prior to vaccination, and at Day 28 post vaccination for assessment of IgA and IgG antibodies with a standard ELISA assay. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons' vaccines, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and Day 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.|||units/mL||95% Confidence Interval|Geometric Mean
1410010|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Breast Milk Following Vaccination.|Breast milk was collected from all maternal participants prior at Days 2 and 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 and 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
1410011|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 8 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 8 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.|||participants|||Number
1410012|NCT01181323|Secondary|Number of Maternal and Infant Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 2 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal and infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 2 post vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.|||participants|||Number
1410013|NCT01181323|Secondary|Number of Maternal Participants Positive for the Season-specific LAIV Influenza A Strain in Respiratory Secretions at Day 0 Who Were Positive for H1N1 and/or H3N2 Strains.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. Those who were positive for the Influenza A strain were further tested to identify the H1N1 and H3N2 strain.|Day 0 prior to vaccination|The analysis population is limited to participants who were positive by PCR and/or cell culture for the vaccine strain of Influenza A.|||participants|||Number
1410014|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
1410015|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all infant participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
1410016|NCT01181323|Secondary|Number of Infant Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all infant participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
1410017|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 8 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 8 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 8 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
1423331|NCT01070784|Primary|Vital Signs- Sitting Systolic Blood Pressure(SBP)|Change from baseline|Baseline and 52 week after||||mmHg||Standard Deviation|Mean
1410018|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Quantitative Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
1410019|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Local Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of nasal congestion, runny nose, cough, sore throat, nasal bleeding, pain at injection site, tenderness at injection site, and swelling at injection site for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
1410020|NCT01181323|Primary|Number of Maternal Participants Reporting Solicited Subjective Systemic Symptoms After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, weakness, and chills for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
1410021|NCT01181323|Primary|Number of Maternal Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Day 0-7 post vaccination|All enrolled maternal participants are included in this analysis population.|||participants|||Number
1410022|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions at Day 2 Post Vaccination.|Nasal swab samples were collected from all maternal participants at Day 2 post vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 2 post vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
1410023|NCT01181323|Secondary|Number of Maternal Participants With Season-specific LAIV Influenza A and B Strains Detected in Respiratory Secretions Prior to Vaccination.|Nasal swab samples were collected from all maternal participants prior to vaccination for PCR and cell culture to assess for the presence of the viruses in the LAIV vaccine in respiratory secretions. The data coordinating center selected 25% of participants in the TIV group for testing to serve as an internal control for the assay.|Day 0 prior to vaccination|All participants with samples selected for testing by the data coordinating center, 100% of LAIV recipients and 25% of TIV recipients, are included in the analysis.|||participants|||Number
1410024|NCT01181323|Secondary|Geometric Mean Titers (GMT) in Maternal Sera of Hemagglutination Inhibition (HAI) Antibodies to Each of the Influenza Strains in the Vaccine Received|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection for the assay was a titer of 10, sera samples below detection were given a value of 5 for analysis.|Day 0 and 28 post vaccination|All enrolled maternal participants with results reported are included in this analysis population.|||titer||95% Confidence Interval|Geometric Mean
1410025|NCT01181323|Primary|Number of Infant Participants With Medically Attended Respiratory or Gastrointestinal AEs 28-42 Days After Maternal Vaccination|Maternal participants were contacted by telephone at Day 42 to report all medically attended respiratory or gastrointestinal adverse events occurring in the infant participants between 28 and 42 days after maternal vaccination.|Within 28-42 days after maternal vaccination|All infant participants for whom the maternal participants were contacted are included in the analysis population description. One maternal participant was not contacted.|||participants|||Number
1410026|NCT01181323|Primary|Breast Milk ELISA IgA and IgG Geometric Mean Titers (GMT) to Each of the Vaccine Influenza Strains|Breast milk was collected at Day 0 prior to vaccination and again at 28 days following vaccination for testing in IgA and IgG ELISA Assays. The ELISA assay was conducted with the antigens in the 2011-2012 seasonal influenza vaccine, A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008, those in the 2012-2013 seasonal influenza vaccine, A/Victoria/361/2011 and B/Wisconsin/1/2010, and the antigen in both seasons's vaccine, A/California/7/2009 (H1N1). The lower limit of detection is 5.82 units/mL for IgA and 2.56 units/mL for IgG. Titers below the limit of detection were reported as one-half the limit of detection.|Day 0 and 28 post vaccination|All enrolled maternal participants are included in this analysis population.|||units/mL||95% Confidence Interval|Geometric Mean
1410027|NCT01181323|Primary|Number of Participating Reporting Non-serious Unsolicited Adverse Events Related to Vaccination Within 28 Days of Maternal Vaccination|Adverse events (AE) for this protocol used the International Conference on Harmonization (ICH) guideline E6 definition of AE, any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product regardless of its causal relationship to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product. Related was defined as a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event. Non-serious AEs were those that did not meet the definition of serious (see Outcome Measure 1). Maternal participants were queried at each visit through 28 days after vaccination for the occurrence of any AE for her or the infant separately from the pre-defined solicited symptoms.|Day 0 to Day 28 post vaccination|All enrolled participants are included in the analysis population for this outcome measure|||participants|||Number
1410028|NCT01181323|Primary|Number of Infant Participants Reporting Solicited Systemic Adverse Events Within 11 Days of Maternal Vaccination|Maternal participants maintained a memory aid to record daily the occurrence in their infants of systemic adverse events of fever (defined as rectal temperature 37.8 degrees Celsius or greater), drowsiness, irritability/fussiness, loss of appetite, nasal congestion, difficulty breathing, runny nose, and cough for 11 days (Day 0-10) after maternal vaccination based on protocol-defined grading (none, mild, moderate or severe) for each symptom. Rectal temperature was measured once daily. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 11 days.|Day 0 to Day 10 post vaccination||||participants|||Number
1410029|NCT01181323|Primary|Number of Participants Reporting New Onset Chronic Medical Conditions|New onset chronic medical condition was defined as any new ICD-10 diagnosis for a participant that was expected to continue for at least 6 months and require continued health care intervention. ICD-10 = International Statistical Classification of Diseases and Related Health Problems, 10th revision. Maternal participants were asked at each visit through 180 days after enrollment if they or their infants had any new diagnosis.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.|||participants|||Number
1410030|NCT01181323|Primary|Number of Participants Reporting Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes, regardless of relationship to study product or study participation.|Day 0 to Day 180 post vaccination|All enrolled participants are included in the analysis population for this outcome measure.|||participants|||Number
1410031|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant||two years|Participants who ONLY underwent Autologous transplant, did not proceed to Allogeneic transplant|||percentage of participants||90% Confidence Interval|Number
1410032|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant||Two Years|Participants who ONLY underwent Autologous transplant (did not proceed to Allogeneic)|||percentage of participants||90% Confidence Interval|Number
1410033|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for All Participants||2 years||||percentage of participants||90% Confidence Interval|Number
1410034|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for All Participants||2 years||||percentage of participants||90% Confidence Interval|Number
1410035|NCT01181271|Secondary|Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants||Two-years after Allogeneic Transplant||||percentage of participants||90% Confidence Interval|Number
1410036|NCT01181271|Secondary|Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants||2 years after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
1410037|NCT01181271|Secondary|Cumulative Incidence of Disease Relapse||2-years after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
1410038|NCT01181271|Secondary|Cumulative Incidence of Non-relapse Mortality|Non-relapse mortality is defined as participants who die from causes other than their underlying disease relapse, such as infection or graft versus host disease|2-years after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
1410039|NCT01181271|Secondary|Cumulative Incidence of Extensive Chronic Graft-versus-host-disease|Extensive chronic graft versus-host-disease (GVHD) was defined as GVHD that required systemic immunosuppression.|1-year after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
1410040|NCT01181271|Secondary|Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD)|Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.|within 200 days after allogeneic transplant||||percentage of participants||90% Confidence Interval|Number
1410041|NCT01181271|Secondary|Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL||within 28 days after allogeneic transplant|This was only measured in the 17 participants who experienced a hematological nadir after allo transplant.|||days||Full Range|Median
1410042|NCT01181271|Primary|Peripheral Blood All-cell Donor Chimerism|Successful donor stem cell engraftment is defined as when ≥ 80% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood at day 100 after non-myeloablative allogeneic stem cell transplantation.|100 days post allogeneic transplant|Participants who underwent the full tandem AUTO-ALLO stem cell transplant|||percentage of donor-derived elements||Full Range|Median
1410043|NCT01181258|Secondary|Patients With Expansion of NK Cells|Number of patients who experience in vivo expansion of allogeneic donor natural killer (NK) cells.|Day 14|Two participants were not evaluable. One patient died prior to receiving NK cell infusion and one did not survive by day 14; therefore 14 patients were analyzed for this outcome measure.|||Participants|||Count of Participants
1410044|NCT01181258|Secondary|Time to Disease Progression|Cumulative incidence will be used to determine time to disease progression.|Day 1 through Month 12|10 participants had disease progression|||days||Full Range|Median
1410045|NCT01181258|Secondary|Serious Adverse Events|Number of participants experiencing serious adverse events that occur during study. Adverse event collection for the purposes of this study will focus on targeted adverse events and unexpected adverse events at specific time points in relation to the NK cell infusion and post infusion IL2 injections.|Day 1 through Month 12|One participant developed sepsis prior to receiving the NK cell infusion and was withdrawn from the study.|||Participants|||Count of Participants
1410088|NCT01181128|Primary|Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values From Baseline|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. ULN=upper limit of normal.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc n=the number of participants with at least one post-baseline value.|||participants|||Number
1410368|NCT01178281|Secondary|Euro QOL 5 Dimension Questionaire|The EQ-5D is a standardized instrument that measures health outcomes for a wide range of health conditions.|Up to treatment discontinuation||2018-08-31|08/2018||||
1410046|NCT01181258|Primary|Number of Patients With an Objective Response|The number of patients with a partial response (PR) or complete response (CR). For patients with non-hodgkin's lymphoma: CR - complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR - at least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses. For patients with chronic lymphocytic leukemia: CR - disappearance of all palpable disease, normalization of the blood counts without transfusions, bone marrow aspirate lymphocyte percentage < 30%, and no evidence of disease on bone marrow biopsy. PR - 50% or more reduction in palpable disease as well as one or more of the remaining features: neutrophils >= 1.5 × 109/L or 50% improvement over baseline, platelets more than 100 × 109/L or 50% improvement over baseline, and hemoglobin more than 11.0 g/dL or 50% improvement over baseline without transfusions.|Month 2 Post Infusion|Two participants were not evaluable. One patient died prior to receiving NK cell infusion and one did not survive by day 14; therefore 14 patients were analyzed for this outcome measure.|||Participants|||Count of Participants
1410047|NCT01181167|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding||2 weeks|Safety analyses were performed for the Safety Analysis Set, which was defined as all subjects who were secondarily enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or who had no safety data after the start of study treatment.|||percentage of subjects with bleeds||95% Confidence Interval|Number
1410048|NCT01181167|Primary|Incidence of Subjects With Venous Thromboembolism Events|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity DVT confirmed by bilateral venography at the end of study treatment~Definite diagnosis of symptomatic PE~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE"|2 weeks|The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.|||percentage of subjects with vte events||95% Confidence Interval|Number
1410049|NCT01181141|Secondary|Proportion of Subjects With Venous Thromboembolism Events.||2 weeks|||||||
1410050|NCT01181141|Primary|The Incidence of Major or Clinically Relevant Non-major Bleeding|Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.|2 weeks|Safety Analysis Set defined as all subjects who were secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any study drug, or had no safety data after start of study treatment. However, subjects who had significant GCP violations, but received at least one dose of study drug, safety data were assessed.|||percentage of subjects with bleeds||95% Confidence Interval|Number
1410051|NCT01181128|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||surgeries|Major Surgeries||Number
1410052|NCT01181128|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc, underwent major surgery, and had blood loss during surgery information available.|||mL|Major Surgeries|Full Range|Median
1410053|NCT01181128|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 2 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||IU/kg|Major Surgeries|Full Range|Median
1410054|NCT01181128|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes, including from the loading dose to the end date/time of surgery.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||injections|Major Surgeries|Full Range|Median
1410055|NCT01181128|Secondary|Investigators’/Surgeons’ Assessment of Participants’ Response to rFVIIIFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks|Participants in the Full Analysis Set (FAS) who received at least 1 dose of rFVIIIFc and underwent major surgery.|||responses|Major Surgeries||Number
1410056|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 14 and Week 28 in Haemo-QoL III Total Score|The Haemo-QoL III, a quality of life assessment instrument for adolescents with hemophilia, was administered to participants from 13 to 16 years old. This instrument assesses domains specific to living with hemophilia and consists of 12 domains: physical health, feeling, view of yourself, family, friends, others, sports and school, treatment, perceived support, dealing with hemophilia, future, and relationships. Total HAEMO-QoL score is the sum of all raw scores for all subscales for participants for whom at least the minimum number of required questions have been answered. Total scores are presented as the Transformed Scale Score (TSS) from 0-100%, with lower scores indicating a better quality of life. A negative change indicates improvement.|Baseline, Week 14, Week 28|Full Analysis Set: participants 13 to 16 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
1410105|NCT01181011|Secondary|Apparent Clearance of Telmisartan in Plasma Following Extravascular Administration (CL/F)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Telmisartan|||L/h||Standard Deviation|Mean
1410106|NCT01181011|Secondary|Elimination Half-life (t_½) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Telmisartan|||h||Standard Deviation|Mean
1410107|NCT01181011|Secondary|Mean Residence Time of Telmisartan in the Body After Oral Administration (MRT_po)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Telmisartan|||h||Standard Deviation|Mean
1410057|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 28|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 28|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
1410058|NCT01181128|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 14|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (17 years and older). The 10 domains are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (time frame for all 7 domains, during the last month) and future, family planning, and outlook for the future (time frame for all 3 domains, recently). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100. Participants in Arm 1 were stratified by their prestudy regimen (either prophylaxis or on-demand).|Baseline, Week 14|Full Analysis Set: participants over 17 years of age who received at least 1 dose of rFVIIIFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
1410059|NCT01181128|Secondary|Incremental Recovery (Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1410060|NCT01181128|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
1410061|NCT01181128|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1410062|NCT01181128|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
1410108|NCT01181011|Secondary|Terminal Rate Constant in Plasma (λz) of Telmisartan|reflect the speed of drug elimination in vivo|3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Telmisartan|||1/h||Standard Deviation|Mean
1410109|NCT01181011|Secondary|Time to Attain Cmax (Tmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Telmisartan|||h||Standard Deviation|Mean
1410110|NCT01181011|Primary|Cmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days of wash-outs|All patients with values for Cmax of Amlodipine|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1410063|NCT01181128|Secondary|Area Under the Curve (AUC) Per Dose (Two-stage Chromogenic Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1410064|NCT01181128|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which the maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
1410065|NCT01181128|Secondary|Time at Maximum Activity (Tmax; One-stage Clotting Assay)|Time at which maximum activity (Cmax) is observed. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
1410066|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (Two-stage Chromogenic Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||days||95% Confidence Interval|Geometric Mean
1410067|NCT01181128|Secondary|Time to 1% and 3% FVIII Activity (One-stage Clotting Assay)|Estimated time after dose (in days) when FVIII activity has declined to approximately 1 or 3 IU/dL (1% or 3%) above baseline, respectively. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||days||95% Confidence Interval|Geometric Mean
1410068|NCT01181128|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable two-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/kg||95% Confidence Interval|Geometric Mean
1410111|NCT01181011|Primary|AUC_0-∞ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Amlodipine|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1410112|NCT01181011|Primary|AUC_0-tz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Amlodipine|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1410113|NCT01181011|Primary|The Maximum Observed Plasma Concentration (Cmax) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for Cmax of Telmisartan|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1410069|NCT01181128|Secondary|Volume at Steady State (Vss; One-stage Clotting Assay)|Volume of distribution at steady state. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/kg||95% Confidence Interval|Geometric Mean
1410070|NCT01181128|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.|||IU/kg||Inter-Quartile Range|Median
1410071|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see Outcome Measure 20 for a definition of the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had evaluable efficacy assessments; n=total number of bleeds at given location.|||injections||Inter-Quartile Range|Median
1410072|NCT01181128|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
1410073|NCT01181128|Secondary|Number of Days From Last Treatment Injection to a New Bleeding Episode|Number of days from the last injection to treat a bleeding episode to a new bleeding episode, analyzed for per evaluable bleeding episode and per participant. For “per participant” values, number of days from last injection to treat a bleed to a new bleeding episode is averaged across all evaluable bleeding episodes for each participant first, and then descriptive statistics were calculated across participants. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (not evaluable). The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode. The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time.|||days|Evaluable Bleeding Episodes|Inter-Quartile Range|Median
1410074|NCT01181128|Secondary|Annualized Joint Bleeding Rate (Spontaneous and Traumatic)|Annualized bleeding episodes = (Number of bleeding episodes of the specified type / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
1410114|NCT01181011|Primary|Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUC_0-∞) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-∞ of Telmisartan|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1410440|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||9 Months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410075|NCT01181128|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (Number of bleeding episodes at the specified location / number of days in efficacy period) x 365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation were not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with evaluable data.|||episodes per participant per year||Inter-Quartile Range|Median
1410076|NCT01181128|Secondary|Investigator’s Assessment of Participants’ Bleeding Response to rFVIIIFc Injection|The investigator was given the opportunity to record an assessment of a participant’s response to treatment, if the participant was treated in the hospital for a major bleed, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|This supplemental assessment was not summarized because of insufficient data.||||||
1410077|NCT01181128|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 2 weeks|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had at least 1 evaluable bleeding episode; based on the number of injections with an evaluation.|||percentage of responses|Bleeding Episodes||Number
1410078|NCT01181128|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. Overall units (IU/kg) of annualized rFVIIIFc consumption = [Total rFVIIIFc IU/kg received during the efficacy period / number of days in efficacy period] x 365.25.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and >=6 months on study.|||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
1410079|NCT01181128|Secondary|Comparison of Annualized Bleeding Rates: Arm 2 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.|||episodes per participant per year||95% Confidence Interval|Number
1410080|NCT01181128|Primary|Incremental Recovery (One-stage Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1410115|NCT01181011|Primary|Area Under the Concentration-time Curve of Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC_0-tz)||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for AUC_0-tz of Telmisartan|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1410116|NCT01180998|Primary|Distance Visual Acuity (VA)|Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 4 weeks of toric contact lens wear|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.|||logMAR|eyes|Standard Error|Least Squares Mean
1410081|NCT01181128|Primary|Mean Residence Time (MRT; One-stage Clotting Assay)|The average time that a drug molecule is present in the systemic circulation. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
1410082|NCT01181128|Primary|Clearance (CL; One-stage Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1410083|NCT01181128|Primary|Elimination Half Life (t1/2; One-stage Clotting Assay)|Time required for the activity of the drug to reach half of its original value. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||hours||95% Confidence Interval|Geometric Mean
1410084|NCT01181128|Primary|Area Under the Curve (AUC) Per Dose (One-stage Clotting Assay)|Dose normalized area under the drug concentration-time curve. Sampling for Advate PK profiling was conducted, following at least 96 hours of washout, at these timepoints: preinjection and at either 30 (±3) minutes or 10 (±3) minutes, 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 48 (±2) hours (Day 2), and 72 (±2) hours (Day 3) from the start of the injection. Sampling for rFVIIIFc PK profiling was conducted at Day 0 (directly following at least 96 hours washout from Advate PK profiling or within 4 weeks of the Advate dose or other rFVIII product) and repeated 12 to 24 weeks later at the following timepoints: preinjection and at 30 (±3) minutes (or 10 (±3) minutes), 1 hour (±15 minutes), 6 (±1) hours, 24 (±2) hours (Day 1), 72 (±2) hours (Day 3), 96 (±2) hours (Day 4), and 120 (±2) hours (Day 5) from the start of the injection.|See Measure Description for complete time frame.|Participants who had evaluable one-stage PK profiles for both Advate and baseline rFVIIIFc.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1410085|NCT01181128|Primary|Comparison of Annualized Bleeding Rates: Arm 1 Versus Arm 3|Estimated using the negative binomial model with treatment arm as covariate, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25.The efficacy period in Arm 1 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered part of the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.|||episodes per participant per year||95% Confidence Interval|Number
1410086|NCT01181128|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes during the efficacy period / number of days during the efficacy period)*365.25. The efficacy period in Arms 1 and 2 began with the first prophylactic dose of rFVIIIFc and ended with the last dose (regardless of reason for dosing). The efficacy period in Arm 3 began at the time of last PK rFVIIIFc sampling timepoint and ended at the date of the last study visit. Periods of PK evaluations and surgery/rehabilitation are not included in the efficacy period. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 2 weeks (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc with an efficacy assessment.|||episodes per participant per year||Inter-Quartile Range|Median
1410087|NCT01181128|Primary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFVIIIFc dose. ↑ signifies increase and ↓ signifies decrease.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc and had a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, systolic blood pressure, and diastolic blood pressure.|||participants|||Number
1410089|NCT01181128|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of Advate or rFVIIIFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before the last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or any other medically important event. AEs emergent between the first Advate injection and first on-study rFVIIIFc injection (Sequential PK Subgroup) or during the surgical/rehabilitation period (Surgery Subgroup) are presented separately.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc. For Arm 1, AEs emergent between 1st on-study Advate dose and 1st rFVIIIFc dose are reported as treatment-emergent to Advate (1st column); AEs emergent after 1st rFVIIIFc injection are reported as treatment-emergent to rFVIIIFc (2nd column).|||participants|||Number
1410090|NCT01181128|Primary|Incidence Rate of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% confidence interval (CI) were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFVIIIFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFVIIIFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 2 weeks|Safety Analysis Set: participants who received at least 1 dose of Advate or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
1410091|NCT01181102|Secondary|Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.||2 weeks|The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment|||percentage of subjects with bleeds||95% Confidence Interval|Number
1410092|NCT01181102|Primary|Incidence of Subjects With Venous Thromboembolism Events.|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.~Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment~Definite diagnosis of symptomatic Pulmonary Embolism (PE)~Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE)"|2 weeks|Efficacy Analysis population. 22 (7.4%) - DU-176b 41 (13.9%) - enoxaparin|||percent of participants with VTE events||95% Confidence Interval|Number
1410093|NCT01181050|Secondary|Change in DAS28-CRP After 24 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.|Week 0, Week 24|Change in DAS28-CRP was calculated by using last observation carried forward method.|||scores||Standard Deviation|Mean
1410094|NCT01181050|Secondary|Change in DAS28-CRP After 6 Weeks of Treatment.|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.|Week 0, Week 6|Change in DAS28-CRP was calculated by using last observation carried forward method.|||scores||Standard Deviation|Mean
1410095|NCT01181050|Primary|Change in DAS28-CRP After 12 Weeks of Treatment|DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient’s disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.|Week 0, Week 12|Change in DAS28-CRP was calculated by using last observation carried forward method.|||scores||Standard Deviation|Mean
1410096|NCT01181011|Secondary|Number of Participants With Clinically Relevant Findings in Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities||4 weeks|Treated set|||Participants|||Number
1410097|NCT01181011|Secondary|Number of Participants With at Least One Treatment Emergent Adverse Event||4 weeks|Treated set|||Participants|||Number
1410098|NCT01181011|Secondary|V_z/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Amlodipine|||L||Standard Deviation|Mean
1410099|NCT01181011|Secondary|CL/F of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for CL/F of Amlodipine|||L/h||Standard Deviation|Mean
1410100|NCT01181011|Secondary|t_½ of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for t_½ of Amlodipine|||h||Standard Deviation|Mean
1410101|NCT01181011|Secondary|MRT_po of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for MRT_po of Amlodipine|||h||Standard Deviation|Mean
1410102|NCT01181011|Secondary|λz of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for λz of Amlodipine|||1/h||Standard Deviation|Mean
1410103|NCT01181011|Secondary|Tmax of Amlodipine||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for tmax of Amlodipine|||h||Standard Deviation|Mean
1410104|NCT01181011|Secondary|Apparent Volume of Distribution During the Terminal Phase λz Following an Extravascular Administration (V_z/F) of Telmisartan||3 periods of single-dose treatment (8 days of sampling) separated by 21 days wash-outs|All patients with values for V_z/F of Telmisartan|||L||Standard Deviation|Mean
1410117|NCT01180998|Primary|Distance Visual Acuity|Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction.|after 1 week of toric contact lens wear|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.|||logMAR|eyes|Standard Error|Least Squares Mean
1410118|NCT01180998|Primary|Overall Success in Fitting With a Toric Contact Lens|Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome.|4 weeks|All subjects that were dispensed a study lens except those that discontinued for non-clinical reasons.|||percentage of participants||95% Confidence Interval|Number
1410119|NCT01180985|Secondary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||CLUE score||Standard Deviation|Mean
1410120|NCT01180985|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
1410121|NCT01180985|Primary|Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.|Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||CLUE score||Standard Error|Least Squares Mean
1410122|NCT01180985|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 7 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
1410123|NCT01180985|Primary|Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.|The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 7 +/-1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||CLUE score||Standard Error|Least Squares Mean
1410124|NCT01180985|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||participants|||Number
1410125|NCT01180985|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.|after 7 +/- 1 days of lens wear|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
1410126|NCT01180894|Secondary|The Number of Participants Who Died||28 Days||||participants|||Number
1410127|NCT01180894|Secondary|Infection|"The number of participants with at least one infection.~Specific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI)."|28 Days||||participants|||Number
1410128|NCT01180894|Secondary|Iron-deficient Erythropoeisis (IDE)|An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.|14 Days||||micro mol: mol heme||Full Range|Mean
1410129|NCT01180894|Primary|RBC Transfusion|The number of participants who underwent RBC transfusion.|42 Days||||participants|||Number
1410130|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|Change from baseline in log10 HCV RNA level by visit.|Week 12|Efficacy analysis was performed on the virology population , which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result|||log10 HCV RNA level||Standard Deviation|Mean
1410131|NCT01180790|Secondary|Segment 1 and Segment 2: HCV RNA Change From Baseline|The mean change from baseline in log10 HCV RNA level by visit for the virology population|Week 4|Efficacy analysis was performed on the virology population, which was a subset of the ITT population and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result|||log10 HCV RNA Level||Standard Deviation|Mean
1410132|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response ( Six Months Post Dosing) (SVR24)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, six months post dosing.|6 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR24.|||percentage of participants|||Number
1410133|NCT01180790|Secondary|Segment 1 and Segment 2: Sustained Virologic Response 12 Weeks ( Three Months Post Dosing) (SVR12)|The percentage of the Virology Population subjects that achieved sustained virologic response, defined as HCV RNA < LOQ, at 12 weeks (three months) post dosing.|3 months post dosing|Segment 2 analyzed the Per Protocol Population (PPP=all randomized subjects completing 12 wks of ACH-014625 + an extra 12 wks of Peg/RBV) who returned for SVR12.|||percentage of participants|||Number
1410134|NCT01180790|Secondary|Segment 1 and Segment 2: End of Treatment Response|The percentage of the Virology Population subjects that were reported as undetectable HCV RNA at the completion of treatment.|Week 48 (Segment 1); Week 24 (Segment 2)|Segment 2 analyzed the Per Protocol Population, which includes all randomized subjects who completed 12 weeks of ACH-014625 dosing and an additional 12 weeks of Peg/Ribavirin dosing.|||percentage of participants|||Number
1410135|NCT01180790|Secondary|Segment 2: RVR4 (Rapid Viral Response at 4 Weeks)|For Segment 2, the percentage of subjects in the virology population that achieved RVR4, defined as HCV RNA< or equal to LOQ at the Week 4 visit.|4 weeks|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 4 weeks of ACH-0141625 dosing.|||percentage of participants|||Number
1410136|NCT01180790|Secondary|Segment 1: Complete Early Virologic Response (cEVR)|For Segment 1, the percentage of subjects in the virology population that achieved cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|12 weeks|Analysis for Segment 1 was performed on the virology population (which is the same as the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.|||percentage of participants|||Number
1410137|NCT01180790|Primary|Segment 2: Complete Early Virologic Response (cEVR)|The primary efficacy endpoint for Segment 2 of the study was the percentage of subjects achieving cEVR (complete early virologic response), defined as undetectable HCV RNA at Week 12.|Week 12|Per protocol virology population (a subset of the virology population) and included all randomized subjects who completed 12 weeks of ACH-0141625 dosing.|||percentage of participants|||Number
1410138|NCT01180790|Primary|Segment 2: Safety|Segment 2: Percentage of Subjects with the following: adverse events, abnormal laboratory safety tests and dose reductions, interruptions and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|12 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625. Subjects were analyzed according to the randomized treatment.|||percentage of participants|||Number
1410139|NCT01180790|Primary|Segment 1 : Rapid Viral Response at Week 4 (RVR4)|The primary efficacy endpoint for Segment 1 of the study was the percentage of subjects in each treatment group achieving RVR at Week 4 (HCV RNA< or equal to LOQ at the Week 4 visit).|4 weeks|Efficacy analysis was performed on the virology population (a subset of the ITT population) and included all subjects who had a baseline HCV RNA result and at least 1 post baseline HCV RNA result.|||percentage of participants|||Number
1410140|NCT01180790|Primary|Segment 1: Safety|Segment 1: Percentage of subjects with the following: adverse events, abnormal laboratory safety tests, dose reductions, interruptions, and discontinuations. Criteria for abnormal laboratory safety tests: treatment-emergent worsening DAIDs graded laboratory tests.|4 weeks|The safety population, which was defined as all subjects randomized and treated with at least one dose of ACH-0141625 or Placebo. Subjects were analyzed according to the randomized treatment.|||percentage of participants|||Number
1410141|NCT01180777|Secondary|Corneal Staining|Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.|After 6-9 days of lens wear|All subjects who successfully completed the study.|||eyes|eye||Number
1410142|NCT01180777|Secondary|Binocular Snellen Visual Acuity (VA)|Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.|10-15 minutes post lens fit|All subjects who successfully completed the study.|||participants|||Number
1410143|NCT01180777|Primary|Lens Fit Acceptance|Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.|10-15 minutes post lens fit|All subjects who successfully completed the study.|||eyes|Eyes||Number
1410144|NCT01180660|Secondary|24 Hour Total Opioid Consumption|24 hour total opioid consumption using IV morphine equivalents|24 hours post surgery||||miligrams||Inter-Quartile Range|Median
1410145|NCT01180660|Primary|Quality of Recovery 40 on the Day After Surgery|"Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.~The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery."|24 hours||||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
1410146|NCT01180647|Secondary|Adverse Events and Serious Adverse Events|AEs and SAEs per standard definitions will be measured by self-report.|Eight weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||participants|||Number
1410147|NCT01180647|Secondary|Accidental Drug Overdose|Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||participants|||Number
1410148|NCT01180647|Secondary|Injection Drug Use Post-release|This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.|Four weeks post-release||||percentage of participants by arm|||Number
1410149|NCT01180647|Secondary|Any Opioid Use Post-release|Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||percentage of participants|||Number
1410150|NCT01180647|Secondary|Participation in Community Drug Treatment Post-release|This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.|Four weeks post-release|One XR-NTX participant who was randomized was excluded from final data analysis because he was never released from jail to community.|||percentage of participants|||Number
1410388|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Lesion Treated Subgroup|ID-TVF rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410151|NCT01180647|Primary|Post-Release Opioid Relapse|Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.|Four weeks post-release|One XR-NTX participant randomized was excluded from final data analysis due to the fact he was never released from jail to community, so primary outcome (post-release opioid relapse) could not be measured.|||participants||95% Confidence Interval|Number
1410152|NCT01180478|Secondary|Recurrence Rate Related to Additional Treatment Following TURB.||Until 135 days|Only 61 of the patients in the total population in the NBI group, and 69 of the patients in the total population of the WL group received a Re-TURBT after initial TURBT (within 135 days). These numbers therefore differ and deviate from the Participant Flow module.|||participants|||Number
1410153|NCT01180478|Secondary|Risk Factors for the Development of Peri-operative Morbidity After Instrumental Treatment.|We looked at different perioperative complications in order to discover peri-operative morbidity after instrumental treatment. The following variables were analyzed: Bleeding, Fever, UTI, Bladder cramps, DVT, CVA/TIA, Lung embolism, Sepsis, Acute Abdomen, and Other perioperative complications.|peri-operative|The variables contain missing values, therefore the numbers in the below table differs from the overall numbers reported|||Participants|||Count of Participants
1410154|NCT01180478|Secondary|Peri-operative Morbidity (30 Days) of TURB Between NBI and WL Resection Using the Clavien System.|"Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.~Grade II Requiring pharmacological treatment with drugs other than those allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.~Grade III Requiring surgical, endoscopic or radiological intervention Grade III-a Intervention not under general anaesthesia Grade III-b Intervention under general anaesthesia~Grade IV Life-threatening complication (including CNS complications: brain haemorrhage, ischaemic stroke, subarachnoid bleeding, but excluding transient ischaemic attacks) requiring IC/ICU management Grade IV-a Single organ dysfunction (including dialysis) Grade IV-b Multi-organ dysfunction~Grade V Death of a patient"|30 days|"The Clavien grading of perioperative complications variable contains missings, therefore the valid percentages are presented in the outcome measure data table. The NBI group had 2 missing values, and the WL group had 3 missing values. Therfore, the overall number deviates from 484 and 481.~Below shown is a categorical variable with 8 categories"|||Participants|||Count of Participants
1410155|NCT01180478|Secondary|Number of Participants With Persistence/Recurrence of Tumors at First 3 Month Follow up After NBI Versus WL Cystoscopy and Tumor Resection||3 months after treatment||||Participants|||Count of Participants
1410156|NCT01180478|Primary|Number of Participants With Recurrence and Recurrence Rate at 1 Year Following Narrow Band Imaging and TURB (Arm A) Versus White Light Trans Urethral Resection of Bladder Cancer (TURB) (Arm B) in Patients With Non Muscle Invasive (pTa/T1) Bladder Cancer.|The primary outcome measure was recurrence rate at 1 year. A recurrence was defined as the new occurrence of a bladder cancer at the same site as or at a different site from the index cancer.|1 year after treatment||||Participants|||Count of Participants
1410157|NCT01180400|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410158|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410159|NCT01180400|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410160|NCT01180400|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1423332|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
1410161|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410162|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410163|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410164|NCT01180400|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410165|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410166|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410167|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410168|NCT01180400|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410169|NCT01180400|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1410301|NCT01178944|Secondary|Number of Participants With an Adverse Event|Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. Incidence of toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 30 days after the last dose of study drug(s)|All treated and eligible patients|||participants|||Number
1410170|NCT01180400|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410171|NCT01180400|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410172|NCT01180400|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1410173|NCT01180400|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
1410174|NCT01180400|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1410175|NCT01180400|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1410176|NCT01180400|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1410177|NCT01180400|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1410178|NCT01180296|Secondary|Serum Progesterone Levels||At approximately 28 weeks' gestation|||||||
1410179|NCT01180296|Primary|Rate of Recurrent Preterm Birth|Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.|Prior to 37 weeks' gestation||||participants|||Number
1410180|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a sleep visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater difficulty with sleep. The change in Fibromyalgia Impact Questionnaire sleep visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents sleep improvement (i.e. a better outcome), while a positive value represents sleep worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionnaire|||units on a scale||Standard Deviation|Mean
1410181|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale|The Fibromyalgia Impact Questionnaire includes a pain visual analog scale (VAS) with ranges of 0-10 centimeters. Higher values represent greater pain. The change in Fibromyalgia Impact Questionnaire pain visual analog scale is determined by subtracting baseline VAS values from end of treatment VAS values. Thus, a negative value represents pain improvement (i.e. a better outcome), while a positive value represents pain worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare|||units on a scale||Standard Deviation|Mean
1410182|NCT01180244|Secondary|Change in Fibromyalgia Impact Questionnaire Overall Score|The Fibromyalgia Impact Questionnaire yields a score ranging from 0 to 100, with higher scores representing a greater impact or level of symptoms. The change in Fibromyalgia Impact Questionnaire is determined by subtracting scores at baseline from scores at end of treatment. Thus negative numbers represent symptom improvement (i.e. a better outcome) and positive numbers represent symptom worsening (i.e. a worse outcome).|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment|Participants who correctly completed the outcome questionniare|||units on a scale||Standard Deviation|Mean
1410183|NCT01180244|Secondary|Change in Number of Positive Tender Points|"The number of positive tender points ranges from 0-18, and are defined per criteria set forth by the American College of Rheumatology and based on dolorimetry measurements made on 18 prescribed tender point locations. A tender point is considered positive if less than 4 kilograms per centimeter squared pressure is required to elicit a painful response. The change in number of positive tender points is determined by subtracting the number of positive tender points at baseline from the number of positive tender points at end of treatment. Thus, a negative number represents pain improvement (i.e. better outcome), whereas a positive number represents a worsening of pain (i.e. worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment||||Number of positive tender points||Standard Deviation|Mean
1410184|NCT01180244|Primary|Change in Tender Point Pain Threshold|"Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of less pain sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome)."|Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment||||units on a scale||Standard Deviation|Mean
1410185|NCT01180127|Secondary|VO2max|measured at randomization, i.e., before exposure to the intervention, and then again after completion of the 12-week intervention|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the exercise, food additive lacking flavanol group had unusable data for this outcome and thus are not included in these analyses.|||mL/(kg·min)||Standard Deviation|Mean
1410186|NCT01180127|Secondary|Modified Rey Auditory Verbal Learning Test|Participants are read a list of words over three learning trials and the subject is asked to free recall as many words as possible after each trial. These 3 trials are followed by 1 learning trial of a distracter list and then a short delayed free recall trial of the initial list. After approximately 60-minutes, subjects are asked to freely recall words from the initial list, then to recall words form the distracter list, and then complete a forced-choice recognition trial. A source memory trial is administered in which subjects are read each presented word and then asked to identify whether they were initially presented during the 3 learning trials or during the distracter trial. Measured as a retention score (ratio) for which the number of words recalled after the short delay is divided by the number of words recalled on the third learning trial.|Up to 12 weeks after exercise/dietary intervention exposure|There were 4 subjects (1 in exercise, dietary intervention; 2 in no exercise, dietary intervention, and 1 in exercise, food additive lacking flavanol) who did not have useable data and are thus not included in analyses.|||ratio||Standard Deviation|Mean
1410187|NCT01180127|Primary|ModBent (Modified Benton Visual Retention Test)|This is an object recognition task. Participants view a complex stimulus, then are asked to select which one of two objects was identical to the studied stimulus. After a series of these matching trials, during the subsequent recognition trials participants are shown serially individual complex objects and asked to indicate whether the object was identical to any of the target stimuli viewed during the matching trials. Their reaction time for correct responses, measured in milliseconds, is the unit of measurement.|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, dietary intervention and one subject in the no exercise, dietary intervention group had outlying (larger than 3 standard deviation from mean) ModBent values that were deleted and hence those groups have 7 and 10 subjects analyzed rather than 8 and 11 respectively.|||milliseconds||Standard Deviation|Mean
1410315|NCT01178671|Secondary|Adverse Effects|as assessed by Side Effect Checklist|up to 24 weeks|intent to treat|||percentage of subject dropped due to AEs|||Number
1410316|NCT01178671|Secondary|Remission Status|Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score <20 at endpoint|up to 24 weeks|intent to treat|||percentage of subjects|||Number
1410188|NCT01180127|Primary|CBV-fMRI (Cerebral Blood Volume-functional Magnetic Resonance Imaging)|In steady state conditions, CBV is an indirect measure of basal metabolism in the brain. CBV-fMRI is a technique that generates maps of basal metabolism across different brain regions|Up to 12 weeks after exercise/dietary intervention exposure|One subject in the exercise, food additive lacking flavanol arm, and one subject in the wait list control food additive without flavanol arm had non useable data for this outcome which is why there are only 8 subjects analyzed in those two arms rather than 9.|||percent CBV in a brain region||Standard Deviation|Mean
1410189|NCT01180049|Secondary|Quantify the Potential Effect of TEMSR on AUC and Cmax|"Potential TEMSR effects were investigated by calculating the ratio of AUCs with and without concomitant TEMSR from the model-estimated effect of TEMSR on apparent clearance (CL/F) values and using individual ratios of observed Cmax values with and without concomitant temsirolimus, for both parent and metabolite. The AUC mean ratio was calculated as 1 / mean shift on apparent clearance from TEMSR, and the 90% CI of the AUC ratios was calculated as 1 / 90% CI of the shift on apparent clearance from TEMSR.~AUC: Area under plasma concentration-time curve from time zero to infinity Cmax: Characterization of maximum observed plasma concentration"|From one week predose (Day -7, -4hr, -8hr, -48hr) upto 2 weeks post dose (4hr, 8hr, 48hr and Day 8)|The analysis was done on ITT Population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Ratio||90% Confidence Interval|Mean
1410190|NCT01180049|Secondary|Percentage of Participants With Treatment-emergent Bleeding-related AEs|"To assess the safety through percentage of participants with treatment-emergent bleeding-related AEs (Grade 2 or Higher).~TEAE: Treatment start date ≤ adverse event start date or adverse event worsened with respect to grade after treatment started"|From screening (Day -28 to Day -1) until end of treatment (within 30 days of last TEMSR infusion)|Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety|||Percentage of participants|||Number
1410191|NCT01180049|Secondary|Percentage of Participants With Treatment-emergent Infection- Related AEs|To assess the safety through percentages of participants with treatment-emergent infection- related AEs TEAE: Treatment start date ≤ adverse event start date or adverse event worsened with respect to grade after treatment started|From screening (Day -28 to Day -1) until end of treatment (within 30 days of last TEMSR infusion)|Analysis was done on safety population which included any participant who received at least 1 dose of TEMSR was included in the evaluation for safety|||Percentage of participants|||Number
1410192|NCT01180049|Secondary|Investigator Assessed PFS|"PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.~PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.~PFS assessment was done using EMA guidelines for sensitivity analysis censoring.~Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment."|From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Months||80% Confidence Interval|Median
1410193|NCT01180049|Secondary|Investigator’s Assessment ORR (ORR = CR + PR)|"ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.~Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR."|From randomization date until end of treatment (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Percentage of participants||80% Confidence Interval|Number
1410194|NCT01180049|Secondary|Independent Assessment - Objective Response Rate (ORR = CR + PR)|"ORR is defined as the percentage of participants with confirmed CR or PR according to the Cheson Criteria relative to all randomized Participants. Tumor responses were determined using information from objective measurements from computed tomography information including B-symptom evaluation, physical examination, ECOG performance status, assessment of liver and spleen, laboratory assessments such as bone marrow biopsies and/or aspirates, biochemical markers of disease activity and hematology results.~Participants who did not have on-study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the (CT) scans, as well as clinical assessment of ORR."|From randomization date until end of treatment (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Percentage of participants||80% Confidence Interval|Number
1410195|NCT01180049|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of death due to any cause.|From randomization date until death (average follow up done for 18.6 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Months||80% Confidence Interval|Median
1410196|NCT01180049|Primary|Independently Assessed Progression-free Survival (PFS)|"PFS is defined as the time from randomization to first documentation of disease progression by the independent assessor or to death due to any cause, whichever occurred first.~PFS = (earliest date of progression or death due to any cause- randomization date+1)/30.4.~PFS assessment was done using EMA guidelines for sensitivity analysis censoring.~Participants who were alive and progression-free at the time of analysis were censored on the date of last assessment; participants without adequate baseline assessment or without post-baseline assessments were censored on the randomization date; participants who died or progressed after 2 or more missed visits were censored on the date of last tumor assessment prior to the missing visit; and participants who started new anti-cancer therapy prior to death or progression were censored on the date of last tumor assessment prior to the start of anti-tumor treatment."|From randomization date to the date of first documentation of progression or death (average follow up done for 15 months)|The analysis was done on ITT population which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug dose from that to which they were randomized.|||Months||80% Confidence Interval|Median
1410197|NCT01179984|Secondary|Primary Target Lesion Patency|Percentage of participants with Primary Target Lesion Patency (TLP) at 12 months post-index procedure|12 months post-index procedure|Primary Target Lesion Patency (TLP) at 12 months post-index procedure.|||percentage of participants|||Number
1410198|NCT01179984|Primary|(Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.|"Safety:~Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure."|30 day follow-up|Freedom from occurrence of death, amputation and TVR/TLR at 30-days post-index procedure.|||percentage of freedom from events|||Number
1410199|NCT01179984|Primary|Acute Effectiveness: Percentage of Stents With Successful Delivery|"Effectiveness:~Acute effectiveness defined as the successful delivery of the stent with the post-deployment stent length being within 10% of the pre-deployment length."|At implantation (Day 0)||||percentage of stents|Stents|95% Confidence Interval|Mean
1410200|NCT01179919|Secondary|Steady-State Cmax and Cmin of Oseltamivir Carboxylate|Cmax is the maximum concentration and Cmin in the minimum concentration of oseltamivir carboxylate measured in nanogram of oseltamivir carboxylate per milliliter of plasma (ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir|||ng/mL||Standard Deviation|Mean
1410201|NCT01179919|Primary|Steady-State AUC of Oseltamivir Carboxylate|AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour*ng/mL)|6 days|Subjects who received all 9 doses of oseltamivir|||hour*ng/mL||Standard Deviation|Mean
1410202|NCT01179737|Secondary|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated.|168 days|||||||
1410203|NCT01179737|Primary|Change in Pulmonary Vascular Resistance (PVR)|Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.|168 days|||||||
1410204|NCT01179737|Secondary|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. Study was prematurely terminated and efficacy data were not analyzed or summarized|Baseline, 168 days|||||||
1410205|NCT01179672|Secondary|Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score|SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Scores ≥5 were associated with significant functional impairment. A negative change indicated an improvement in the participant's condition. LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing SDS Total Score at baseline and 12 weeks.|||units on a scale||Standard Error|Least Squares Mean
1410206|NCT01179672|Secondary|Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score|BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes). A negative change indicates an improvement in the participant's condition. LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|All participants with non-missing BPI-Interference score at baseline and 12 weeks.|||units on a scale||Standard Error|Least Squares Mean
1410207|NCT01179672|Secondary|Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score|BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline BPI-Severity average pain scores.|||percentage of participants|||Number
1410224|NCT01179516|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
1410208|NCT01179672|Secondary|Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain|24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain). Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in average daily pain) divided by (number of participants) multiplied by 100.|Baseline, 12 weeks|All participants with a baseline and postbaseline 24-hour average pain score.|||percentage of participants|||Number
1410209|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ|SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain. The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe). Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain). A negative change indicates an improvement. LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12 weeks SF-MPQ score based on the randomized group were analyzed; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1410210|NCT01179672|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint|PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|12 weeks|All participants with a baseline and 12-week PGI-I score.|||units on a scale||Standard Error|Least Squares Mean
1410211|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale|CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week CGI-S score based on the randomized group were analyzed. Data from 9 sites was not included in analysis due to wrong questionnaire used.|||units on a scale||Standard Error|Least Squares Mean
1410212|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale|BPI-Severity Scale was a self-reported scale that measured the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week, 24-hour BPI-Severity score based on the randomized group were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1410213|NCT01179672|Secondary|Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain|24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). A negative change indicated an improvement in the participant's condition. LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|ITT principle was applied: All participants with a baseline and 12-week 24-hour night pain score and worst pain score based on the randomized group were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1410214|NCT01179672|Primary|Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score|24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The weekly mean was calculated. A negative change indicated an improvement in participant's condition. Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, 12 weeks|Intent-to-treat (ITT) principle was applied: All participants with a baseline and 12-week 24-hour average pain score based on the randomized group were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1410215|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk20||Standard Deviation|Mean
1410242|NCT01179490|Secondary|CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]|"The proportion of subjects evaluated as CR [strict CR (sCR) + CR] was calculated.~sCR (IMWG): CR as defined below plus Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~CR (IMWG): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
1410441|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||6 Months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410216|NCT01179568|Secondary|Change From Baseline in Work and Social Adjustment Scale (WSAS)|The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk12||Standard Deviation|Mean
1410217|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.|Baseline and week 20|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk20||Standard Deviation|Mean
1410218|NCT01179568|Secondary|Change From Baseline in Inventory of Complicated Grief (ICG)|The 19-item self-report instrument assesses symptoms of complicated grief. Responses on individual items are added up to a total score, which can range from 0 to 76 with higher scores indicating more intense symptoms. This scale has been utilized previously in treatment studies of CG. Additional times points include weeks 4, 8, 12, 16, 20 and 40. For the pre-specified analyses we compared change in the ICG total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.|Baseline and week 12|Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.|||score change from baseline to wk12||Standard Deviation|Mean
1410219|NCT01179568|Primary|Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale|Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.|Weeks 12 and 20|Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting .|||percentage of responders|||Number
1410220|NCT01179516|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1410221|NCT01179516|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
1410222|NCT01179516|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥ 20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1410223|NCT01179516|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1410317|NCT01178671|Secondary|Response Status|Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint|up to 24 weeks|intent to treat|||percentage of subjects|||Number
1423333|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
1410225|NCT01179516|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1410226|NCT01179490|Secondary|Pharmacokinetic Parameters (t1/2)|Plasma pharmacokinetics (t1/2) of unchanged bendamustine|On Day 1 only||||h||Standard Deviation|Mean
1410227|NCT01179490|Secondary|Pharmacokinetic Parameters (AUC)|Plasma pharmacokinetics (AUC) of unchanged bendamustine|On Day 1 only||||ng・h/mL||Standard Deviation|Mean
1410228|NCT01179490|Secondary|Pharmacokinetic Parameters (Tmax)|Plasma pharmacokinetics (tmax) of unchanged bendamustine|On Day 1 only||||h||Standard Deviation|Mean
1410229|NCT01179490|Secondary|Pharmacokinetic Parameters (Cmax)|Plasma pharmacokinetics (Cmax) of unchanged bendamustine|On Day 1 only||||ng/mL||Standard Deviation|Mean
1410230|NCT01179490|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.|Up to 2 years||||Events|||Number
1410231|NCT01179490|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.~grade 1 : mild~grade 2 : moderate~grade 3 : severe or medically significant but not immediately life-threatening~grade 4 : life threatening or disabling~grade 5 : death related to AE"|Up to 2 years||||Participants|||Number
1410232|NCT01179490|Secondary|Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years||||Events|||Number
1410233|NCT01179490|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).|Up to 2 years||||Participants|||Number
1410234|NCT01179490|Secondary|Overall Survival (OS)|OS is the period from the date of patient registration to the date of death.|Up to 2 years||||Days||Full Range|Median
1410235|NCT01179490|Secondary|Duration of Response (DOR)|DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.|Up to 2 years||||Days||Full Range|Median
1410236|NCT01179490|Secondary|Time to Treatment Failure (TTF)|TTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment.|Up to 2 years||||Days||Full Range|Median
1410237|NCT01179490|Secondary|Progression-Free Survival (PFS)|"PFS is the period from patient registration to either the date of recurrence, exacerbation, progression or death.~Recurrence, exacerbation, progression were assessed from serum M-protein, urine M-protein, serum free light chain (FLC), the percentage of marrow plasma cells, disappearance of clonal plasma cells, plasma cell tumor in soft tissue, and bone lesion."|Up to 2 years||||Days||Full Range|Median
1410238|NCT01179490|Secondary|Response Rate (Based on the Modified SWOG Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (SWOG) requires the followings:~Decline in myeloma protein of ≥25%–<74% in serum myeloma protein~Reduction in 24h urinary myeloma protein of ≥25%–<89%~No increase in skeletal destruction~Serum calcium within normal range"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
1410239|NCT01179490|Secondary|Response Rate (Based on the Bladé Criteria)|"The proportion of subjects evaluated as response (CR + PR) was calculated.~PR (Bladé) requires 1. or all of the others:~Some, but not all, of the criteria for CR are fulfilled~≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks.~Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks.~For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks.~≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination).~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)."|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
1410240|NCT01179490|Secondary|CR Rate Based on the (Bladé) Criteria|"The proportion of subjects evaluated as CR was calculated.~CR (Bladé) requires all of the followings:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR.~No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)~Disappearance of soft tissue plasmacytomas"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
1410241|NCT01179490|Secondary|Response Rate (Based on the IMWG Criteria)|"The proportion of subjects evaluated as response [sCR + CR + very good partial response (VGPR) + Partial Response (PR)] was calculated.~VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 h~PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to <200mg per 24 h"|Up to 36 weeks||||Percentage of participants||95% Confidence Interval|Number
1410243|NCT01179490|Primary|Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]|"The proportion of subjects evaluated as CR was calculated.~CR (modified SWOG) requires all of the followings:~Decline in serum myeloma protein by ≥75% to ≤25 g/L~Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h~No increase in skeletal destruction~Serum calcium within normal range~No blood transfusion required in the previous 3 months"|Up to 36 weeks||||Percentage of Participants||95% Confidence Interval|Number
1410244|NCT01179399|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960|Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)|up to 12 months|Maximum tolerable dose (MTD) and recommended phase 2 dose (RP2D) of TAK-960 were not determined due to sponsor decision to discontinue the study for business reasons.||||||
1410245|NCT01179347|Secondary|Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score|Different format of CFQ-R are used depending of the patients' age. Adolescent and adult format of CFQ-R is used for patients of 14 years and older, for younger children a parent version and a children format is used. In case parent and children questionnaires were filled out, the children questionnaire is taken into account. Scores were calculated for each domain of the CFQ-R which are presented separately. A score of 100 corresponds to the highest quality of life possible, whereas a score of 0 corresponds to the lowest quality of life possible. Increasing score indicates better health.|Baseline and 12 weeks|FAS reduced to patients having CFQ-R information at baseline and at week 12.|||Units on a scale||Standard Deviation|Mean
1410246|NCT01179347|Secondary|Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment|Selected questions from the Respiratory and Systemic Symptoms Questionnaire (RSSQ), the investigator assessment of physical findings and pulmonary function, and the use of intravenous antibiotics as a concomitant therapy were used to determine if a cystic fibrosis-related pulmonary exacerbation had occurred.|12 weeks|FAS reduced to patients having RSSQ information on day 29, 57 or 85.|||Percentage of Participants|||Number
1410247|NCT01179347|Secondary|Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25−75) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. FEF25−75 is also known as maximum mid-expiratory flow and was measured before bronchodilator (salbutamol) use. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
1410248|NCT01179347|Secondary|Trough FVC Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FCV was defined as the pre-dose FVC measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
1410249|NCT01179347|Secondary|Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FVC AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
1410250|NCT01179347|Primary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.|Baseline and 12 weeks|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
1410251|NCT01179347|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response|Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).|30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.|Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients <5 years of age were included in the FAS.|||Percent of predicted||Standard Error|Mean
1410389|NCT01178268|Other Pre-specified|ID-TVF Rate in Patients Without Diabetic Disease|ID-TVF rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410252|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing HR describes an average within-subject increase in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min*h||Standard Deviation|Mean
1410253|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine HR Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine HR describes an average within-subject change in HR from baseline over a time-period of 4 hours post-dose (Note that the area only takes values above the individual baseline for the respective visit into account. The area that would result from a decrease from baseline is not taken into account for the calculation of the area). Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min*h||Standard Deviation|Mean
1410254|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
1410255|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine DBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of supine DBP describes an average within-subject change in DBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
1410256|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Standing SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under effect curve (AUEC) at each visit of standing SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
1410257|NCT01179334|Secondary|Area Under Effect Curve (AUEC) of Supine SBP Within 4 Hours Post-dose at Visit 6 (Week 12)|The area under the effect curve (AUEC) at each visit of supine SBP describes an average within-subject change in SBP from baseline over a time-period of 4 hours post-dose (Note that the area only takes values below the individual baseline for the respective visit into account. The area that would result from an increase from baseline is not taken into account for the calculation of the area). Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg*h||Standard Deviation|Mean
1410258|NCT01179334|Secondary|Maximum Change From Baseline in Standing Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min||Standard Deviation|Mean
1410259|NCT01179334|Secondary|Maximum Change From Baseline in Supine Heart Rate (HR) Within 4 Hours Post-dose at Visit 6 (Week 12)|Heart rate (HR) was measured as standard vital sign parameter. Range allowed in this study: <= 105 beats per minute (bpm) in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum increase from baseline (or zero if baseline was higher than all subsequent HR measurements in that profile) within 4 hours post-dose. Baseline was the last HR recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||Beats/min||Standard Deviation|Mean
1410260|NCT01179334|Secondary|Maximum Change From Baseline in Standing Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg||Standard Deviation|Mean
1410261|NCT01179334|Secondary|Maximum Change From Baseline in Supine Diastolic Blood Pressure (DBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Diastolic blood pressure (DBP) was measured as standard vital sign parameter. Range allowed in this study: <= 110 mmHg. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent DBP measurements in that profile) within 4 hours post-dose. Baseline was the last DBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg||Standard Deviation|Mean
1410318|NCT01178671|Secondary|Depression Severity|as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression).|up to 24 weeks|intent to treat|||units on a scale||Standard Deviation|Mean
1410262|NCT01179334|Secondary|Maximum Change From Baseline in Standing Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|PD analysis set|||mmHg||Standard Deviation|Mean
1410263|NCT01179334|Primary|Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12)|Systolic blood pressure (SBP) was measured as standard vital sign parameter. Range allowed in this study: <= 180 mmHg. In addition, SBP must be >=95 mmHg in the first 2 hours after intake of background treatment with sildenafil. The maximum change from baseline at each visit was defined as the within-subject maximum decrease from baseline (or zero if baseline was lower than all subsequent SBP measurements in that profile) within 4 hours post-dose. Baseline was the last SBP recorded at and within 30 minutes before intake of study drug.|Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12)|pharmacodynamic(s) (PD) analysis set|||mmHg||Standard Deviation|Mean
1410264|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (respiration). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.|||breaths/min||Standard Deviation|Mean
1410265|NCT01179217|Secondary|Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (temperature). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.|||degree C||Standard Deviation|Mean
1410266|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (pulse rate). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, Week 24 and Week 48|Safety Population which includes all patients that took at least one dose of study medication.|||bpm||Standard Deviation|Mean
1410267|NCT01179217|Secondary|The Effect of Oral L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (reticulocyte count), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.|||1000 cells/uL||Standard Deviation|Mean
1410268|NCT01179217|Secondary|The Effect of Oral L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (hematocrit), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.|||% of red blood cells||Standard Deviation|Mean
1410269|NCT01179217|Secondary|The Effect of Oral L-glutamine on Vital Signs|To assess the effect of oral L-glutamine on Vital signs (systolic and diastolic blood pressure). Change from Baseline will be reported at Weeks 4, 24, and 48.|Baseline, Week 4, 24, and 48|Safety Population which includes all patients that took at least one dose of study medication.|||mm Hg||Standard Deviation|Mean
1410270|NCT01179217|Secondary|The Effect of Oral -L-glutamine on Hematological Parameters|To assess the effect of oral L-glutamine on hematological parameters (hemoglobin), Change from Baseline will be reported at Weeks 4, 24 and 48.|Baseline, Week 4, 24 and 48|Safety population - The safety population included all patients who received at least 1 dose of study medication.|||g/dL||Standard Deviation|Mean
1410271|NCT01179217|Secondary|The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain|The number of emergency room visits or medical facility visits that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.|||Number of ER visits||Full Range|Median
1410272|NCT01179217|Secondary|The Number of Hospitalizations for Sickle Cell Pain|The number of hospitalizations that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.|||Number of hospitalizations||Full Range|Median
1410273|NCT01179217|Primary|The Number of Occurrences of Sickle Cell Crises|The number of occurrences of protocol-defined sickle cell crises that occur from Week 0 to Week 48 will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.|48 weeks|Intent-to-Treat Population - Included all patients who were randomized and dispensed study medication.|||Number of crises||Full Range|Median
1410274|NCT01179191|Other Pre-specified|Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
1410284|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.|||Days||Standard Deviation|Mean
1410275|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Illicit Substances|Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
1410276|NCT01179191|Other Pre-specified|Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
1410277|NCT01179191|Other Pre-specified|Number of Participants With Abnormal Urine Drug Test Results|Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy [3, 4-methylenedioxyamphetamine (MDMA)], cocaine, phencyclidine (PCP) and marijuana [tetrahydrocannabinol (THC)]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Participants|||Number
1410278|NCT01179191|Other Pre-specified|Number of Participants With Aberrant Behaviors|Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale [0 = ‘never’ and 4 = ‘very often’]. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.|Day 5|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.|||Participants|||Number
1410279|NCT01179191|Secondary|Investigator's Level of Satisfaction With the EMBEDA Conversion Guide|The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator’s level of satisfaction with the EMBEDA Conversion Guide.|Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a Scale||Standard Deviation|Mean
1410280|NCT01179191|Secondary|Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)|BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), ‘0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference’.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Baseline, Visit 3 (up to Week 6)|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for the respective subscale.|||Units on a scale||Standard Deviation|Mean
1410281|NCT01179191|Secondary|Percentage of Participants With Rescue Medications Usage During Titration|Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1410282|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.|||titration steps||Standard Deviation|Mean
1410283|NCT01179191|Secondary|Number of Titration Steps to Achieve Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||titration steps||Standard Deviation|Mean
1429626|NCT01012414|Secondary|Effect on Carotid Intima-media Thickening (CIMT)||1 year|Data were not collected when study was stopped prematurely.||||||
1410285|NCT01179191|Secondary|Duration to Titrate Participants to Stable Dose|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
1410286|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Participants were stratified based on prior opioid therapy. The 'n' is signifying those participants who were evaluated for this measure for each of the prior medication received.|||Percentage of participants||95% Confidence Interval|Number
1410287|NCT01179191|Primary|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase|A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.|Baseline through Week 6|Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.|||Percentage of participants||95% Confidence Interval|Number
1410288|NCT01179113|Secondary|Postoperative Nausea and Vomiting|Number of participants that experienced Postoperative nausea and vomiting using at PACU|1 day||||participants|||Number
1410289|NCT01179113|Secondary|Opioid Consumption in PACU Obtained From the Recorded Data|Postoperative use of opioid (Hydromorphone) consumption inside hospital at PACU (recorded by study staff and data obtained from patient charts).|1 day||||mg||Standard Deviation|Mean
1410290|NCT01179113|Primary|Post-operative Pain Using Verbal Rating Scale (VRS)|"Verbal Rating Scale goes from 0 to 10, where:~0 indicates= No pain and 10 indicates= The worst possible pain~The information was be recorded by study staff and data obtained from patient and patient charts from post-anesthesia care unit (PACU) stay"|1 day||||Scores on a scale||Standard Deviation|Mean
1410291|NCT01179048|Secondary|Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.|Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects|||Percentage of subjects|||Number
1410292|NCT01179048|Secondary|Time From Randomisation to First Occurrence of a Composite Microvascular Outcome|"Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:~new onset of persistent macroalbuminuria~persistent doubling of serum creatinine~need for continuous renal replacement therapy~death due to renal disease~need for retinal photocoagulation or treatment with intravitreal agents~vitreous haemorrhage~diabetes-related blindness~The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented."|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.|||Percentage of subjects|||Number
1410293|NCT01179048|Secondary|Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome|Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All the randomised subjects.|||percentage of subjects|||Number
1410294|NCT01179048|Secondary|Time From Randomisation to All Cause Death|Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects|||percentage of subjects|||Number
1410295|NCT01179048|Secondary|Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.|Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.|||percentage of subjects|||Number
1410296|NCT01179048|Primary|Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)|Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.|from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)|All randomised subjects.|||percentage of subjects|||Number
1410297|NCT01178944|Other Pre-specified|MicroRNA Expression - miR-215-5p|Mean microRNAs expression of mi-215-5p in tumor tissues of responders and non-responders using a microfabricated device called a gene chip.|Baseline|All treated participants that had enough tissue to perform microdissection to collect epithelial cells for subsequent microRNA profiling.|||Arbitrary fluorescent intensity||95% Confidence Interval|Mean
1410302|NCT01178944|Primary|Overall Response Rate|Overall response rate to combination pralatrexate and oxaliplatin as assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Objective responses will be confirmed 4 weeks after first documentation of response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|All Cohort -1 treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1410303|NCT01178853|Primary|Percent Mean Change From Baseline of International Normalized Ratio (INR)|INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)|22 Days||||percent change||Standard Deviation|Mean
1410304|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10|Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
1410305|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10|Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
1410306|NCT01178827|Secondary|Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10|Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
1410307|NCT01178827|Secondary|Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10|Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.|Baseline, 10 Days|Per Protocol: All subjects who completed the study.|||Scores on a Scale||Standard Deviation|Mean
1410308|NCT01178827|Secondary|Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 2 Post-Dose|All patients who received of Oxybutynin IR|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
1410309|NCT01178827|Secondary|Plasma Levels of Sanctura XR® at Day 10 Post-dose|Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.|Day 10 Post-Dose|All patients who received of Sanctura XR®|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
1410310|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose|Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.|Day 2 Post-Dose|All patients who received Oxybutynin IR|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
1410311|NCT01178827|Primary|Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose|Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.|Day 10 Post-Dose|All patients who received Sanctura XR®|||Nanograms (ng) per milliliter (mL)||Standard Deviation|Mean
1410312|NCT01178762|Primary|Total Number of Participants With Negative Chlamydia Direct Fluorescent Antibody (DFA) Test Results After Oral Azithromycin Treatments|We performed direct fluorescent antibody (DFA) tests for Chlamydia by swabbing across the lower and upper tarsal conjunctiva four times after topical application of 0.5% proparacaine. All of the DFA tests were examined by the same experienced microbiologist who was masked to the identities and clinical conditions of the patients. Each DFA slide was read under a fluorescent microscope and was observed for discrete fluorescent chlamydial elementary bodies (EBs).The DFA test was considered positive if above 10 EBs were counted per high-power field.|4 weeks, 8 weeks and 12 weeks after the first dose of the medication|Only participants with confirmed DFA tests are counted in the results below. Participants with confirmed negative DFA tests subsequently stopped treatment and were not retested. Participants lost to follow-up are counted as not having a confirmed DFA negative test|||participants|||Number
1410313|NCT01178671|Secondary|Sexual Functioning|as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired).|up to 24 weeks|intent to treat|||units on a scale||Standard Deviation|Mean
1410314|NCT01178671|Secondary|Sleep Quality|as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired).|up to 24 weeks|intent to treat|||units on a scale||Standard Deviation|Mean
1410323|NCT01178528|Secondary|New York Heart Association (NYHA) Class|"The 1994 NYHA Classification system is a measure of functional status. It was designed for clinical assessment of patients by physicians as NYHA class I, II, III, or IV, on the basis of patient’s limitations in physical activities caused by cardiac symptoms.~Class I describes patients with cardiovascular disease (CVD) but without resulting limitation of physical activity. There is no objective evidence of CVD.~Class II describes patients with CVD resulting in slight limitation of physical activity. There is objective evidence of minimal CVD.~Class III describes patients with CVD resulting in marked limitation of physical activity. There is objective evidence of moderately severe CVD.~Class IV describes patients with CVD resulting in inability to carry on any physical activity without discomfort. There is objective evidence of severe CVD.~Here we report data on number of patients showing an improvement by at least one NYHA class according to treatment allocation."|3 months||||participants|||Number
1410324|NCT01178528|Primary|Maximal Oxygen Consumption|Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.|3 months||||mL/Kg/min||Standard Deviation|Mean
1410325|NCT01178528|Secondary|Quality of Life|Quality of life (QoL) was evaluated using the Visual Analogue Scale (VAS) which is a global measurement of QoL, allowing a subjective assessment of the impact of the disease and treatment. Patients are asked to indicate their current state in a line from 0 (worst state) to 10 (best state), with higher values therefore representing a better outcome.|3 months||||units on a scale||Standard Deviation|Mean
1410326|NCT01178528|Primary|Exercise Tolerance Assessed by 6 Minute Walking Test|"Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist.~Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible."|3 months||||meters||Standard Deviation|Mean
1410327|NCT01178385|Secondary|Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).|This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
1410328|NCT01178385|Secondary|Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)|This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
1410329|NCT01178385|Primary|Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)|This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
1410330|NCT01178333|Secondary|Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn||From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
1410331|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge||From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
1410332|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.||||days||95% Confidence Interval|Median
1410333|NCT01178333|Primary|Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.||||days||Standard Error|Mean
1410334|NCT01178333|Secondary|Use of Treatment (Non-heparin Anticoagulant) Used in Hospital|Types of treatment (direct thrombin inhibitor, fondaparinux, warfarin, no treatment) provided to subjects in hospital|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
1410335|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint|Heparin PF-4 OD test results were the dichotomous outcome (<1.0 vs. >=1.0). Primary endpoint was the composite endpoint of death, limb amputation/gangrene, or new thrombosis.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
1410336|NCT01178333|Secondary|Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia|Heparin PF-4 optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Nadir Platelet Count (x10^9 / L) was used for the degree of thrombocytopenia. The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||X10^9 / L||Standard Deviation|Mean
1410337|NCT01178333|Secondary|Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis|Heparin PF-4 (platelet factor 4) optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Clinical diagnosis was three groups (HIT-T, Isolated HIT and No HIT). The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first|There was one missing data for optical density test results in Isolated HIT group. Therefore, 283 subjects were used for Isolated HIT group.|||participants|||Number
1410338|NCT01178333|Secondary|Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). LMWHs are derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn||||participants|||Number
1410339|NCT01178333|Secondary|Type of Heparin Exposure - Unfractionated Heparin (UFH)|Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). UFH has been used for the prevention and treatment of thrombosis for several decades.|Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn||||participants|||Number
1410340|NCT01178333|Secondary|Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT|"Proportion of subjects who, at the time the positive heparin PF-4 antibody test was drawn, were in each of the following categories:~Group 1: Those with thrombosis and or without thrombocytopenia (HIT-T): 16% of 442 subjects.~Group 2: Those with thrombocytopenia but not thrombosis (Isolated HIT): 64% of 442 subjects.~Group 3: Those with neither thrombocytopenia nor thrombosis (Neither HIT-T nor Isolated HIT): 20% of 442 subjects."|From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn||||participants|||Number
1410341|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The median survival time is reported by each group for the time to occurrence of major bleeding.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||95% Confidence Interval|Median
1410342|NCT01178333|Secondary|Time to Occurrence of Major Bleeding|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
1410343|NCT01178333|Secondary|Time to Occurrence of Radiographically Confirmed Thromboembolism|"The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. However, the median survival times could not be defined for all three groups, so the mean time was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
1410344|NCT01178333|Secondary|Time to Occurrence of Limb Amputation or Limb Gangrene|"Due to the small number of events, the median or mean survival time could not be defined. Therefore, the number of subjects with limb amputation or limb gangrene was reported in Outcome Measure Data Table."|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||participants|||Number
1410345|NCT01178333|Secondary|Time to Death|The median survival time is reported by each group for the time to death.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||95% Confidence Interval|Median
1410346|NCT01178333|Secondary|Time to Death|The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.|From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first||||days||Standard Error|Mean
1410347|NCT01178294|Secondary|Number of Participants Who Developed an Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|21 subjects in the ITT population (n=29) with available baseline and follow-up test results|||participants|||Number
1410348|NCT01178294|Secondary|Number of Participants Who Developed de Novo Anti-OBI-1 Antibody Titers||Through 90 days ± 7 days following final OBI-1 dose|28 eligible subjects with acquired hemophilia A in the ITT population (n=29), of whom 18 had no detectable anti-porcine FVIII inhibitor titers at baseline (<0.6 BU) and 10 had detectable anti-porcine FVIII antibody titers at baseline (>=0.6 BU)|||participants|||Number
1410349|NCT01178294|Other Pre-specified|Anti-human Factor VIII Antibody Titer||Through 90 days ± 7 days following final OBI-1 dose|Anti-human factor VIII antibody titer data were presented in subject data listings. No statistical test was planned for anti-human factor VIII antibody titer.||||||
1410350|NCT01178294|Secondary|PK Analysis- Terminal Half-life|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. Half-life was calculated as the time it took to reduce percent activity by half.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population|||hours||Standard Deviation|Mean
1410351|NCT01178294|Secondary|PK Analysis- Area Under the Concentration-time Curve (AUC) From Time 0 to the Last Measurable Concentration|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics. AUC was calculated as area under the percent activity-time curve.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population|||percent activity*hours||Standard Deviation|Mean
1410353|NCT01178294|Secondary|Pharmacokinetics (PK) Analysis- Plasma Clearance|Participation in the PK sampling was optional. PK parameters obtained from the non-bleeding state were summarized with descriptive statistics.|Pre-infusion 15-20 minutes, Post-infusion 1, 3, 6, 12, 18, 24 hours|PK population (= all subjects in the ITT population who consent to PK draws and have factor VIII levels measured at the central reference laboratory)|||U/(percent activity*hours)||Standard Deviation|Mean
1410354|NCT01178294|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode||Through 90 days ± 7 days following final OBI-1 dose|Because of expected sparseness of positive anti-OBI-1 antibody titers, formal statistical analyses of correlation were not performed.||||||
1410355|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|29 subjects (ITT population) had responses available at 24 hours after initial infusion of OBI-1.|||participants with bleeds controlled|||Number
1410356|NCT01178294|Secondary|Correlation Between Response to OBI-1 Therapy at 16 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|All 19 subjects in the ITT population (n=29) who had responses available at 16 hours after initial infusion of OBI-1 had a positive response.|||subjects with eventual bleed control|||Number
1410357|NCT01178294|Secondary|Correlation Between Positive Response to OBI-1 Therapy at 8 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours||24 hours|Of 21 subjects in the ITT population (n=29) with responses available at 8 hours after initial infusion of OBI-1, 20 had a positive response.|||subjects with eventual bleed control|||Number
1410358|NCT01178294|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.|||infusions per participant||Standard Deviation|Mean
1410359|NCT01178294|Secondary|Total Dose of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes|'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.|||dose in U/kg||Standard Deviation|Mean
1410360|NCT01178294|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes|'Frequency of infusions' was calculated as the 'average number of infusions per day'. 'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.|Time of successful control of qualifying bleeding episode (varied from participant to participant)|The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.|||average number of infusions per day||Standard Deviation|Mean
1410361|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|16 hours|19 subjects of the ITT population (n=29) had responses available at 16 hours after initial infusion of OBI-1.|||percentage of serious bleeding episodes|Responses Available at 16 hrs|95% Confidence Interval|Number
1410362|NCT01178294|Secondary|Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator|A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.|8 hours|21 subjects of the ITT population (n=29) had responses available at 8 hours after initial infusion of OBI-1.|||percentage of serious bleeding episodes|Responses Available at 8 hrs|95% Confidence Interval|Number
1410363|NCT01178294|Secondary|Overall Percentage of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator|Treatment success was defined as control of qualifying bleeding episode at the time of final treatment dosing. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.|At the time of final treatment dosing (varied from participant to participant depending on bleeding episodes)|ITT population = 29 subjects with initial serious bleeding episodes (BEs)|||percentage of serious bleeding episodes|Initial Serious Bleeding Episodes|95% Confidence Interval|Number
1410364|NCT01178294|Primary|Percentage of Serious Bleeding Episodes Responsive to OBI-1|"The initial serious (qualifying) bleeding episode for each subject was analyzed for the primary efficacy outcome measure. A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'."|24 hours after initiation of treatment|Intent to Treat (ITT) population = 29 subjects with initial serious bleeding episodes|||percentage of serious bleeding episodes|Initial Serious Bleeding Episodes|95% Confidence Interval|Number
1410365|NCT01178281|Secondary|Overall Survival|The time from randomization to the death or to the latest date when participants are known to be alive.|Up to 2.5 years||2018-08-31|08/2018||||
1410369|NCT01178281|Secondary|Healthcare Resource Utilization|"Characterization of medical resource utilization among participants treated with pomalidomide as compared to subjects receiving placebo treatment.~Information on the length of each hospitalization and other major outpatient resource use will be collected at designated study visits, including major diagnostic procedures and other interventions such as those required for transfusions or for treatment-related adverse events. Additionally, information on major categories of concomitant medications (eg., use of G-CSF, intravenous antibiotics, anti-virals, iron chelation) will be obtained."|Every 28 days||2018-08-31|08/2018||||
1410370|NCT01178281|Secondary|Time to Becoming RBC-transfusion-independent|Number of days from randomization to achieving RBC transfusion independence as assessed every 28 days.|Up to 2.5 years||2018-08-31|08/2018||||
1410371|NCT01178281|Secondary|Duration of RBC-transfusion Independence|Number of days from randomization to achieving RBC transfusion independence as assessed every 28 days.|Up to 2.5 years||2018-08-31|08/2018||||
1410372|NCT01178281|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence|"Defined as the absence of intravenous RBC transfusions for any consecutive rolling 84 day interval (i.e. days 1 to 84, days 2 to 85 etc) before Day 169 visit. A responder is: a. One who received at least two RBC transfusions on/after the first dose of study drug, and at least one ≥ 84 days between two consecutive RBC-transfusions; b. One who received at least one RBC transfusion after the first dose of study drug and no RBC transfusion at the first study drug day, and the time interval between the first dose of study drug and the RBC transfusion date is ≥ 84 days; c. One who received at least one RBC transfusion on/after the first dose of study drug and the time interval between the last RBC transfusion and the last transfusion assessment date is ≥ 84 days; d. One who did not receive any RBC transfusions on and after the first dose of study drug, and the time interval between the first dose of study drug and the date of the last transfusion assessment is ≥ 84 days"|168 days|Intent to Treat Population (ITT) includes all participants that were randomized to either of the two study drugs, regardless of whether or not any study drug was actually taken.|||percentage of participants||95% Confidence Interval|Number
1410373|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410374|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Vessel Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410375|NCT01178268|Other Pre-specified|ID-TLR Rate in Dual Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410376|NCT01178268|Other Pre-specified|ID-TLR Rate in Single Lesion Treated Subgroup|Ischemia-driven target lesion revascularization rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410377|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients Without Diabetic Disease|Ischemia-driven target lesion revascularization rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410378|NCT01178268|Other Pre-specified|ID-TLR Rate in Patients With Diabetic Disease.|Ischemia-driven target lesion revascularization rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410379|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410380|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Vessel Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410381|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Dual Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410382|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Single Lesion Treated Subgroup|The composite of ST, all death, and all MI rate in Patients with single lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410383|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients Without Diabetic Disease|The composite of ST, all death, and all MI rate in Non Diabetes|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410384|NCT01178268|Other Pre-specified|The Composite of ST, All Death, and All MI Rate in Patients With Diabetic Disease.|The composite of ST, all death, and all MI rate in All Diabetes patients.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410385|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Vessel Treated Subgroup|ID-TVF rate in Patients with dual vessel treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410386|NCT01178268|Other Pre-specified|ID-TVF Rate in Single Vessel Treated Subgroup|ID-TVF rate in Patients with single vessels treated during the index procedure.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410387|NCT01178268|Other Pre-specified|ID-TVF Rate in Dual Lesion Treated Subgroup|ID-TVF rate in Patients with dual lesion treated during the index procedure|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1439823|NCT00937235|Secondary|Blood Serum Cotinine|Level of cotinine in blood|At end of 3-month follow-up||||ng/mL||Standard Deviation|Mean
1410400|NCT01178268|Secondary|Follow-up Late Loss|This is one of the Secondary Angiographic Endpoint.|≥13 months.|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
1410401|NCT01178268|Secondary|XIENCE V EECSS Excellent Overall Performance and Deliverability Using the XIENCE V EECSS Performance Evaluation Questionnaire|A related secondary performance goal for XIENCE V EECSS is the physician-determined evaluation of acute performance, deliverability, and resource utilization. XIENCE V EECSS acute performance and deliverability were determined using the XIENCE V EECSS Performance Evaluation Questionnaire. Possible responses included strongly agree,moderately agree, agree, moderately disagree, and strongly disagree. Study physicians who enrolled patients into the study were reported for this outcome measure.|During the procedure||||percentage of participants|||Number
1410402|NCT01178268|Secondary|Fluoroscopy Time|This is the procedure related endpoint.|On day 0, during the procedure.||||Minutes||Standard Deviation|Median
1410403|NCT01178268|Secondary|Amount of Contrast Used|Defined as total amount used from insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.||||Milliliter||Standard Deviation|Median
1410404|NCT01178268|Secondary|Procedure Time|This is the procedure related endpoint. Procedure time is defined as time between insertion of the first guiding catheter until removal of the last guiding catheter.|On day 0, during the procedure.||||Minutes||Standard Deviation|Median
1410405|NCT01178268|Secondary|Acute Procedure Success|Per-protocol procedure success is defined as the achievement of a final in-stent DS of < 50% (by online QCA or visual estimation), using the assigned device and with any adjunctive devices, and occurring without cardiac death, MI (including Q-wave or non–Q-wave), or repeat revascularization of the target lesion during the hospital stay.|< or = 1 day||||percentage of participants|||Number
1410406|NCT01178268|Secondary|Acute Device Success|Per-protocol device success is defined as the achievement of a final in-stent residual diameter stenosis (DS) of < 50% by Quantitative Coronary Angiography (QCA), using only the assigned device, and occurring without a device malfunction.|< or = 1 day||||percentage of participants|Participants||Number
1410407|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410408|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410409|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410410|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410411|NCT01178268|Secondary|Patient Compliance With Dual Antiplatelet Therapy (DAPT)||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410412|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Overall (0 - 772 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410413|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Very late (366 – 772 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410414|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Late (31 – 365 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410415|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Early (0 – 30 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410442|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||30 Days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410443|NCT01178268|Secondary|Major Adverse Cardiac Event (Cardiac Death, All MI and TLR)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410416|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Subacute (1 – 30 days)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410417|NCT01178268|Secondary|Definite / Probable Stent Thrombosis|Stent Thrombosis was adjudicated using Academic Research Consortium (ARC) criteria. Definite Stent Thrombosis defined as angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic changes suggestive of acute ischemia, typical rise and fall of cardiac biomarkers; pathological confirmation of ST through either autopsy or tissue examination following thrombectomy. Probable Stent Thrombosis defined as any unexplained death within the first 30 days or, irrespective of the time after the index procedure, any MI related to documented acute ischemia in the territory of the stent without angiographic confirmation.|Acute (<1 day)|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410418|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410419|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410420|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410421|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410422|NCT01178268|Secondary|Major Bleeding Complications|Secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410423|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410424|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410425|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410426|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410427|NCT01178268|Secondary|Target Vessel Protocol MI (TV-MI)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410428|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410429|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410430|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410431|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410432|NCT01178268|Secondary|All Protocol MI (Including Q-wave or Non–Q-wave)|This is one of the secondary safety endpoint.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410433|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410434|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410435|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410436|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410437|NCT01178268|Secondary|All Death|This is one of the secondary safety endpoint. All Death includes cardiac, vascular, non-cardiovascular.|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410438|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)|One of the Secondary Safety Endpoint was all revascularization rates (target lesion, target vessel, non-target lesion, and non-target vessel) (PCI and CABG).|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410439|NCT01178268|Secondary|All Revascularization (TLR, TVR, and Non-TVR)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410448|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410449|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410450|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410451|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410452|NCT01178268|Secondary|Incidence of Composite of All Death (Cardiac, Vascular and Non-cardiovascular) and All MI||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410453|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410454|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410455|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410456|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410457|NCT01178268|Secondary|All Death(Cardiac, Vascular and Non-cardiovascular), All MI, All Revascularization (TLR, TVR, and Non-TVR) (PCI and CABG)|This is one of the Secondary Composite Endpoint. All death(cardiac, vascular and non-cardiovascular), all MI, all revascularization [(target lesion revascularization (TLR), target vessel revascularization (TVR), and non-target lesion revascularization(TVR) [Percutaneous coronary intervention (PCI) and Coronary artery bypass graft(CABG)].|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410458|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410459|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410460|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410461|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410462|NCT01178268|Secondary|Incidence of Composite of Cardiac Death and MI (Including Q-wave and Non–Q-wave) Attributed to the Target Vessel (TV)||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410463|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410464|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410465|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|This is one of the Secondary Composite Endpoints.|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410466|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410467|NCT01178268|Secondary|Ischemia-driven Target Lesion Failure (ID-TLF)|Incidence of composite of cardiac death, MI attributed to the TV and ID-TLR|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410468|NCT01178268|Secondary|Ischemia-driven Target Lesion Revascularization (ID-TLR) (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])|The is the major Secondary Efficacy Endpoint.|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants||95% Confidence Interval|Number
1410469|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)||24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410470|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)||9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410471|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave).||6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410472|NCT01178268|Secondary|Incidence of Composite of Stent Thrombosis (ST)(Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave).||30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410473|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|24 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410474|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|9 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410475|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG]).|6 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410476|NCT01178268|Secondary|Ischemia-driven Target Vessel Failure (ID-TVF)|Incidence of composite of cardiac death, all MI (including Q-wave and non– Q-wave), and ID target vessel revascularization (ID-TVR) (TLR and non-TLR in the TV [PCI and CABG])|30 days|The number of participants with angiographic follow up available was analysed.|||percentage of participants|||Number
1410477|NCT01178268|Primary|Incidence of Composite of ST (Definite and Probable), All Death (Cardiac, Vascular and Non-cardiovascular), and All MI (Including Q-wave and Non–Q-wave)|The primary composite safety endpoint was the incidence of the composite of ST (definite and probable), all death (cardiac, vascular and non-cardiovascular), and all MI (including Q-wave and non–Q-wave).|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants||95% Confidence Interval|Number
1410478|NCT01178268|Primary|Ischemia-driven Target Vessel Failure (ID-TVF)|This is the primary efficacy endpoint. Ischemia-driven target vessel failure is defined as the composite of cardiac death, all myocardial infarction (MI) and ischemia-driven target vessel revascularization (ID-TVR).|12 months|The number of participants with angiographic follow up available was analysed.|||percentage of participants||95% Confidence Interval|Number
1410479|NCT01178268|Primary|In-stent Late Loss (LL)|"This is the primary angiographic endpoint.~In-stent LL: The difference between the minimum lumen diameter (MLD) immediately after stent deployment and the MLD at follow-up (within stent)"|>=13 months|The number of participants with angiographic follow up available was analysed.|||Millimeter|Participants|Standard Deviation|Mean
1410480|NCT01178138|Primary|Blood Pressure Effects of Prazosin on Methamphetamine|"Blood pressure effects of prazosin on methamphetamine;~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The blood pressure was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the blood pressure was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine||||mmHg||Standard Deviation|Mean
1410481|NCT01178138|Primary|Heart Effects of Prazosin on Methamphetamine|"Heart effects of prazosin on methamphetamine;~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The heart rate was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the heart rate was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine||||beats per minute||Standard Deviation|Mean
1410482|NCT01178138|Primary|Self-report Effects of High.|"Visual analog scales measuring effects prazosin on methamphetamine; change in methamphetamine high. Visual analog scales allow the subject to give a rating of methamphetamine effects. For instance, how high the dose makes you . The study tested how much prazosin changed the effects of methamphetamine as measured by these visual analog scales.~Visual analog scale is a 100 mm scale, ranging from 0 (no effect) to 100 (maximum effect).~In each session, each subject received prazosin (1 or 2 mg) or prazosin placebo. The visual analog scale was measured. Then, one hour later, methamphetamine placebo or methamphetamine (20mg) was given and the visual analog scale was measured again."|0 hr time point after prazosin and 1 hr time point after methamphetamine||||units on a scale||Standard Deviation|Mean
1410483|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle and in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in BMI decile group.|||percentage of pregnancies|||Number
1410548|NCT01177670|Secondary|Safety Endpoints|The Adiana System will be evaluated for safety on the basis of the occurrence of adverse events which are related to the study device, unanticipated or serious.|At one and two years|Intent to treat|||participants|||Number
1410484|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in BMI decile group.|||percentage of pregnancies|||Number
1410485|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in BMI decile group.|||percentage of pregnancies|||Number
1410486|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in body weight decile group.|||percentage of pregnancies|||Number
1410487|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in body weight decile group.|||percentage of pregnancies|||Number
1410488|NCT01178125|Secondary|Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule|Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in the body weight decile group.|||percentage of pregnancies|||Number
1410489|NCT01178125|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other BCMs, including condoms, were used, and who were deemed to be compliant, per protocol.|||pregnancies / cumulative exposure||95% Confidence Interval|Number
1410490|NCT01178125|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used, and who were deemed to be compliant, per protocol.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
1410491|NCT01178125|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
1410492|NCT01178125|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.|||pregnancies / cumulative exposure||95% Confidence Interval|Number
1410493|NCT01178125|Other Pre-specified|Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint|A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris.|Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)|Subset of participants with sufficient tissue at both Baseline and Endpoint biopsies.|||participants|||Number
1410494|NCT01178125|Other Pre-specified|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs|AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event.|Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.|Safety population (received at least 1 dose of DR-102)|||participants|||Number
1410495|NCT01178125|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule|Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or > 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)*(total number of pregnancies)*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered “on drug” if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.|thirteen 28-day cycles|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
1410496|NCT01178099|Secondary|P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12|"PRU-derived VN percent inhibition is calculated as a percent decrease of PRU from baseline using the following formula:~([PRU at baseline – PRU at time of post baseline] / PRU at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
1410497|NCT01178099|Secondary|Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12|Percent aggregation was assessed by Plateletworks® ADP assay, a whole blood-based test of platelet aggregation for the assessment of platelet inhibition. The assay determines the change in single platelet count due to activation and aggregation by ADP and inhibition thereof by antiplatelet agents.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
1410586|NCT01177007|Primary|Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria|This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.|Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.|These data were not collected. See outcome measure #2.||||||
1410498|NCT01178099|Secondary|Change From Baseline in the Area Under the Aggregation Curve at Day 12|AUC to 20 micromolar (μM) adenosine diphosphate (ADP), 6.5μM ADP, Collagen, and thrombin receptor activator for peptide 6 (TRAP-6) were calculated by whole blood multi-electrode aggregometry (MEA) assay. Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve, measured in aggregation units*minutes (AU*min).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||aggregation units*minutes (AU*min)||Standard Deviation|Mean
1410499|NCT01178099|Secondary|Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12|PRI was calculated by vasodilator-associated phosphoprotein (VASP) phosphorylation assay using flow cytometry (FC) and a VASP assay using enzyme-linked immunosorbent assay (ELISA). The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percentage PRI||Standard Deviation|Mean
1410500|NCT01178099|Secondary|Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
1410501|NCT01178099|Secondary|Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251|Cmax was observed from the data and used to calculate geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
1410502|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:~([MPA at baseline – MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
1410503|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by light transmission aggregometry (LTA) at 6 minutes after the addition of 20 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
1410504|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
1410505|NCT01178099|Secondary|Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|"IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:~([MPA at baseline – MPA postbaseline] / MPA at baseline) x 100%"|Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent inhibition||Standard Deviation|Mean
1410506|NCT01178099|Secondary|Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|RPA is the percentage aggregation as measured by LTA at 6 minutes after the addition of 5 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
1410507|NCT01178099|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel’s Inactive Metabolites, R-95913, R-106583, and R-119251|AUC was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
1410632|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|preoperative, 4-6 weeks||||degrees||Standard Deviation|Mean
1423334|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total|Change from baseline|Baseline and 52 week after||||g/dL||Standard Deviation|Mean
1410508|NCT01178099|Secondary|Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12|MPA to 5 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.|Baseline, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||percent aggregation||Standard Deviation|Mean
1410509|NCT01178099|Primary|Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727|Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Day 1, Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram per milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
1410510|NCT01178099|Primary|Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel’s Active Metabolite, R-138727|The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.|Time of dosing up to 8 hours post-dose on Day 1 and Day 12|All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.|||nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
1410511|NCT01178073|Secondary|Change From Baseline in Borg Dyspnea Index at Week 24|Borg Dyspnea Index (BDI) indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI was calculated by using the Borg category (C) ratio (R) CR10 scale which starts at 0 (nothing at all) and has no upper limit (extremely strong). Change from BL was calculated as the Week 24 values minus the BL value. The BDI scale was assessed by each participant. The BL BDI score is the average of the two BDI values obtained following the two 6MWD tests used in determining the BL 6MWD. A negative change from BL in the BDI score represented an improvement for the participant. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline (BL) and Week 24|mITT Population. Only participants with Baseline data were analyzed.|||Scores on a scale||Inter-Quartile Range|Median
1410512|NCT01178073|Secondary|Change From Baseline in the World Health Organization Functional Class at Week 24|The WHO Functional Class (FC) indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). Baseline WHO FC is the latest assessment prior to dosing (i.e., at Randomization or Screening). Change from Baseline at Week 24 was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on the last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observations was assigned the worst-rank score relative to those actually observed and was assigned rank reflecting the relative order of the actual event times.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.|||Scores on a scale||Inter-Quartile Range|Median
1410513|NCT01178073|Secondary|Change From Baseline in the 6 Minute Walk Distance Test at Week 24|The 6-minute walk distance (6MWD) test measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. The analysis was performed based on last observation carried forward data, except in the case of an adjudicated clinical failure event of death or hospitalization preceding the missing data observation. In this case, the missing observation was assigned the worst-rank score relative to those actually observed and was assigned a rank reflecting the relative order of the actual event times. Baseline 6MWD comprised of an average of the last two consecutive measurements prior to randomization that varied by no greater than 10%. If only one measurement was available, that measurement was used. If no two consecutive measures vary by no greater than 10% then Baseline was based on the last two consecutive measures for a participant.|Baseline and Week 24|mITT Population. Only participants with Baseline data were analyzed.|||Meters||95% Confidence Interval|Median
1410514|NCT01178073|Secondary|Percentage of Participants With a Satisfactory Clinical Response at Week 24|A satisfactory clinical response at Week 24 is defined as a participant who meets all of the following criteria: 10% improvement in 6MWD compared with Baseline; improvement to or maintenance of World Health Organization (WHO) class I or II symptoms; no events of clinical worsening prior to or at the Week 24 visit. Clinical worsening events included: death, hospitalization for pulmonary arterial hypertension (PAH), and disease progression. Participants without an event of clinical worsening prior to or at the Week 24 visit who did not have a 6MWD value or a WHO functional class value at Week 24 were excluded from the analysis.|Baseline and Week 24|"mITT Population. Only those participants who had a Yes/No response were analyzed."|||Percentage of participants|||Number
1410515|NCT01178073|Secondary|Percent Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Week 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate marker of heart failure. The data were log-transformed. The geometric mean was calculated (based on the log-transformed data). The geometric mean ratio was calculated as the ratio between the Week 24 value and the Baseline value (based on the log-transformed data) and presented as percent change = 100 * (geometric mean ratio – 1). The Baseline value is the last value prior to administration of study drug; this may be prior to or on the day of study drug initiation. No imputation was performed for missing data. The secondary endpoints were analyzed according to a pre-specified hierarchical testing procedure.|Baseline and Week 24|mITT Population. Only participants with data available at the specified time points were analyzed.|||Percent change||Standard Error|Mean
1410516|NCT01178073|Primary|Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV|Time to the first adjudicated CF event (death, hospitalization for worsening pulmonary arterial hypertension [PAH], disease progression, or unsatisfactory long-term clinical response) after initiating either first-line combination therapy with AMB and TAD or first-line monotherapy with either drug (AMB or TAD) in par. with PAH was assessed. If data was not available for some par. following a loss to follow-up, their event times were treated as censored at their last assessment time for the statistical analyses. FAV occurred approximately 4 weeks after the predicted 105th adjudicated first CF event was reached. Par. who had an FAV, and who had no adjudicated events or whose first adjudicated event occurred after their FAV, were censored at their individual FAV. Modified Intent-to-Treat (mITT) Population: all randomized par. who met the PAH diagnosis and inclusion/exclusion criteria defined in protocol amendment 2 and who also received at least one dose of investigational product (IP).|From Baseline up to the Final Assessment Visit (FAV) (average of 609 days)|mITT Population|||Participants|||Number
1410517|NCT01177969|Secondary|Anxiety Disorders Interview Schedule: Child and Parent Versions|The Anxiety Disorders Interview Schedule: Child and Parent Versions are clinician-rated scales assessing anxiety symptoms and the associated severity and impairment in children over the past month. The clinician interviewer interviews the child and parent separately about the nature and severity of the child's anxiety. If a child meets criteria for an anxiety disorder, a single item is rated by the interviewer, which represents anxiety severity. The scale score for this single item ranges from 0 to 8 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which was an average of 16 weeks after Baseline||||units on a scale||Standard Deviation|Mean
1410518|NCT01177969|Primary|Pediatric Anxiety Rating Scale.|The Pediatric Anxiety Rating Scale is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale includes 5 items which are summed to form a total score, which represents anxiety severity. The scale score ranges from 0 to 25 with higher scores indicating more severe anxiety symptoms.|Post-treatment, which is an average of 16 weeks after Baseline||||units on a scale||Standard Deviation|Mean
1410519|NCT01177956|Secondary|Duration of Response Until Cut-off Date 15 November 2012|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|Subgroup of participants from the study population having best confirmed response (CR or PR).|||months||95% Confidence Interval|Median
1410520|NCT01177956|Secondary|Duration of Response Until Cut-off Date 25 January 2011|Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|Subgroup of participants from the study population having best confirmed response (CR or PR).|||months||95% Confidence Interval|Median
1410521|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 15 November 2012|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
1410522|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 15 November 2012|BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or chemotherapy.|||percentage of participants||95% Confidence Interval|Number
1410523|NCT01177956|Secondary|Time to Progression (TTP) Until Cut-off Date 25 January 2011|Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
1410524|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
1410525|NCT01177956|Secondary|Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011|Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
1410526|NCT01177956|Secondary|Overall Survival (OS) Time Until Cut-off Date 15 November 2012|The OS time was defined as the time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||months||95% Confidence Interval|Median
1410527|NCT01177956|Primary|Best Overall Response (BOR) Until Cut-off Date 25 January 2011|BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization [WHO] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.|Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011|ITT population included all participants who received at least one dose of the IMP cetuximab or chemotherapy.|||percentage of participants||95% Confidence Interval|Number
1410528|NCT01177943|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)]|The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had an AUC value were included in the AUC analysis.|||nanogram hour per milliliter (ng*h/mL)||90% Confidence Interval|Least Squares Mean
1410529|NCT01177943|Primary|Maximum Observed Plasma Concentration (Cmax)|The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose|All participants who had a Cmax value were included in the Cmax analysis.|||nanogram per millileter (ng/mL)||90% Confidence Interval|Least Squares Mean
1410530|NCT01177813|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|"Confirmed hypoglycaemic events refer to all hypoglycaemic events, that had a glucose value <= 70 ml/dL or where assistance was required.~Symptomatic hypoglycaemic events were to be reported as adverse events. Patients can be counted in more than one category."|From first drug intake until 7 days after last medication intake, up to 219 days|Treated set (actual) including all patients treated with at least 1 dose of randomised trial medication with some treatment switchers (1 from Empa25 to placebo; 1 patient got Empa 10 at least with one mis-allocated kit) and open-label set|||percentage of participants|||Number
1410531|NCT01177813|Secondary|Change From Baseline to Week 24 in Systolic and Diastolic Blood Pressure (SBP and DBP)|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive.~For blood pressure, data following changes in antihypertensive therapy is censored, in the same way that data following initiation of rescue medication is censored."|Baseline and week 24|FAS and open-label set, last observation carried forward without values following a change in antihypertensive therapy (LOCF- H) was used as the imputation rule|||mmHg||Standard Error|Mean
1410532|NCT01177813|Secondary|Change From Baseline to Week 24 in Body Weight|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS (LOCF) and open-label set (LOCF)|||kg||Standard Error|Mean
1410533|NCT01177813|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 24 Weeks|"The term “baseline” refers to the last observation before the start of randomised trial treatment (or of open-label treatment for the open-label arm).~In this endpoint, the measured values show unadjusted values, whereas the statistical analyses show adjusted values. Statistics for open-label group are descriptive."|Baseline and day 169|FAS and open-label set, last observation carried forward (LOCF) was used as the imputation rule for both sets|||percent of HbA1c||Standard Error|Mean
1410534|NCT01177800|Other Pre-specified|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability|The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent’s genetic input) anomaly.|Baseline up to end of study (Week 26)|Safety Population included all participants randomly assigned to infliximab or placebo group.|||participants|||Number
1410535|NCT01177800|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26|The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 26|ITT population included all participants randomly assigned to Infliximab or placebo group. 'n' included those participants who were evaluable for this measure at specific time points.|||units on a scale||Standard Deviation|Mean
1410544|NCT01177722|Primary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™|Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.|Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1410536|NCT01177800|Secondary|Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10|The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score <= 1 at week 10 were reported.|Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group.|||percentage of participants|||Number
1410537|NCT01177800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 10|ITT population included all participants randomly assigned to Infliximab or placebo group. Here 'n' included those participants who were evaluable for this measure at specific time points.|||units on a scale||Standard Deviation|Mean
1410538|NCT01177800|Primary|Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI)|The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.|Week 10|Intent to treat (ITT) population included all participants randomly assigned to Infliximab or placebo group.|||percentage of participants|||Number
1410539|NCT01177735|Primary|Progression-free Survival (PFS) After Initiation of Pomalidomide Therapy|Progression -free survival (PFS) after initiation of pomalidomide therapy. Progressive disease is defined as increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL); Urine M-component and/or (the absolute increase must be > 200 mg/24 h); Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; the absolute percentage must be > 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|1 year following initiation of pomalidomide therapy||||percentage of participants|||Number
1410540|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 post each vaccination|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).|||Participants|||Number
1410541|NCT01177722|Secondary|Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.|Day 0 up to 7 after each dose|Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set).|||Participants|||Number
1410542|NCT01177722|Secondary|Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).|Day 0 (pre-vaccination) and 30 days post-dose 3|GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1410543|NCT01177722|Primary|Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine|Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).|30 Days post-dose 3|Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).|||Participants|||Number
1410545|NCT01177709|Secondary|Insulin Level|fasting serum insulin uIU/ml.|baseline, 4 weks, 8 weeks, 12 weeks||||uIU/ml||Standard Error|Mean
1410549|NCT01177670|Primary|Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.|The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.|At one and two years|Efficacy results were not tabulated due to the early termination of the study. Only 169 of the planned 1,000 subjects (16.9%) were enrolled therefore the study is defined as incomplete, as fewer than one-third of the intended patients were enrolled.||||||
1410550|NCT01177553|Secondary|Fetal/Neonatal/Infant Survival of the AGA Fetus 6 Months After Birth, Comparing the SLPCV (Selective Laser Photocoagulation of Communicating Vessels) and Expectant Management Groups.||6 months|||||||
1410551|NCT01177553|Primary|Survival|Effects of surgery or expectant management on postnatal neurological morbidity of the AGA baby. The primary comparison will be between SLPCV (selective laser photocoagulation of communicating vessels) and expectant management.|6 months||||percentage of AGA babies who survived|||Number
1410552|NCT01177410|Primary|The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.|||participants|||Number
1410553|NCT01177410|Secondary|Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period|A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.|3 months|Intent to Treat Population included all randomized subjects who ingested at least one dose of study drug. Analysis of study data was based on observed cases, missing data remained missing.|||participants|||Number
1410554|NCT01177384|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 Weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.|||Participants|||Number
1410555|NCT01177384|Primary|Number of Participants Who Experienced at Least One Adverse Event||Up to Week 24 + 14 Day Post-Study Follow-up|All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.|||Participants|||Number
1410556|NCT01177384|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for the FPG. Last observation carried forward (missing data approach).|||mg/dL||95% Confidence Interval|Least Squares Mean
1410557|NCT01177384|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).|||Percent||95% Confidence Interval|Least Squares Mean
1410558|NCT01177293|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1410559|NCT01177293|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1410560|NCT01177293|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Full Range|Geometric Mean
1410561|NCT01177293|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
1410562|NCT01177293|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
1423335|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Albumin|Change from baseline|Baseline and 52 week after||||g/dL||Standard Deviation|Mean
1410563|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the MAdCAM-1-Fc marker. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"|||percent inhibition*days||Standard Deviation|Mean
1410564|NCT01177228|Primary|Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker|AUEC (0-last) is the area under the drug effect-time curve until the last available time point. Mean percent inhibition over time [AUEC(0-last)] was determined for the Act-1 marker. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin.|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"|||percent inhibition*days||Standard Deviation|Mean
1410565|NCT01177228|Primary|Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the MAdCAM-1-Fc binding interference assay. MAdCAM-1-Fc is a fusion of human MAdCAM-1 with parts of a mouse monoclonal antibody. The assay measures the percent inhibition of the MAdCAM-1-Fc binding to α4β7 integrin due to the presence of vedolizumab binding.~Emax was calculated on Day 1, Day 85, and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"PD Analysis Set; participants with available data (indicated by n)"|||percent inhibition||Standard Deviation|Mean
1410566|NCT01177228|Primary|Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker|"The target of vedolizumab is α4β7 integrin, a receptor found on inflammatory immune cells that guides these inflammatory cells to the gut and binds to the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on gut endothelial cells. The extent of the α4β7 receptor saturation by vedolizumab was assessed using the Act-1 binding interference assay. Act-1 is a mouse antibody similar to vedolizumab that also binds α4β7 integrin. The assay measures the percent inhibition of the Act-1 due to the presence of vedolizumab binding.~Emax was calculated on Day 1, Day 85 and based on all available data."|Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253|"Pharmacodynamic (PD) Analysis Set, defined as all participants for whom there were sufficient data to estimate PD. Analyses only include participants with available data (indicated by n)."|||percent inhibition||Standard Deviation|Mean
1410567|NCT01177228|Primary|Terminal Phase Elimination Half-life (t½) of Vedolizumab|Terminal phase elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose through Day 253|PK Analysis Set; participants with available data|||days||Standard Deviation|Mean
1410568|NCT01177228|Primary|Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab|"AUC was calculated for 3 time intervals during the study:~AUC (Day 0-14): from administration on Day 0 to last quantifiable concentration on Day 14, selected to capture the AUC following the first dose of vedolizumab until administration of the second dose~AUC(Day 85-99): from administration on Day 85 to last quantifiable concentration on Day 99, selected to assess the amount of drug accumulation with the planned loading regimen by comparing it to AUC(Day 0-14)~AUC(Day 85-141): from the first quantifiable concentration on Day 85 to the last quantifiable concentration on Day 141, selected to assess the drug exposure over an 8-week period"|Days 0-14, Days 85-99, Days 85-141|PK Analysis Set; participants with available data at each time point (indicated by “n”).|||day*μg/mL||Standard Deviation|Mean
1410569|NCT01177228|Primary|Cmin: Minimum Observed Plasma Concentration of Vedolizumab|Minimum observed plasma concentration (Cmin) is the lowest plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|PK Analysis Set; participants with available data.|||μg/mL||Standard Deviation|Mean
1410570|NCT01177228|Primary|Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.|"Pharmacokinetic (PK) Analysis Set, defined as all vedolizumab participants for whom there were sufficient data to estimate PK. Analyses only include participants with available data at each time point (indicated by n)."|||µg/mL||Standard Deviation|Mean
1410571|NCT01177228|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. The investigator systematically collected information adequate to determine both the outcome and severity of the AE, and whether or not it was drug-related or met the criteria for classification as a serious adverse event (SAE). An SAE was defined as an AE that resulted in (or posed risk for) death, inpatient hospitalization (or prolonging hospitalization), or congenital, persistent or significant disability/incapacity.~The intensity for each AE was defined according to the following criteria:~Mild: Awareness of sign or symptom, but easily tolerated Moderate: Discomfort enough to cause interference with normal daily activities Severe: Inability to perform normal daily activities."|From the first date of study drug administration through Day 253|Safety Analysis Set, defined as all enrolled participants who received at least 1 dose of study treatment. One participant was randomized but not dosed and is not included in this population.|||participants|||Number
1410572|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.|Week 12|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
1410573|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.|Week 6|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
1410574|NCT01177098|Secondary|Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
1410575|NCT01177098|Secondary|Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
1410576|NCT01177098|Primary|Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.|Week 2|Intent-to-treat population included all randomized participants.|||mm Hg||Standard Deviation|Mean
1410577|NCT01177098|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12|Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 12|Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.|||mm Hg||Standard Deviation|Mean
1410578|NCT01177007|Secondary|Mean Radiation Dose Delivered to Total Liver|Therasphere dose calculation was performed using positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography (SPECT) imaging post-procedure to estimate the actual delivered dose of Theraspheres to the liver.|24 hours|Mean radiation doses were calculated for the total cohort of participants and also stratified according to disease type - colorectal cancer, neuroendocrine, and non-CRC/non-NE.|||Gray||Standard Deviation|Mean
1410579|NCT01177007|Secondary|Safety as Graded by CTCAE Version 3.0|Clinical and biochemical toxicity that were assessed as at least possibly related to treatment were recorded from the day of treatment until protocol exit or death. Toxicities were graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.|12 months|50 participants were assessed for adverse events, with a total of 207 adverse events reported. Two patients had grade 5 toxicities (grade 5 cholecystitis and death), which were attributed to disease progression and were not device-related.|||adverse events|Adverse Events||Number
1410580|NCT01177007|Secondary|Overall Survival (OS) Rate at 2 Years|"Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as open-ended. At the time of results reporting, this outcome was presented as Up to 2 years. Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. 2-year OS rates were also stratified based on tumor burden."|Up to 2 years|2-year OS rate for all patients (n=50) were analyzed and also stratified based on tumor burden: Patients with tumor burden of 25% or less (n=34) and patients with tumor burden greater than 25% (n=16).|||percentage of participants|||Number
1410581|NCT01177007|Secondary|Overall Survival (OS)|"Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as open-ended. Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type."|Median follow-up time was 11.41 months (CI: 1.5-33.7)|Median OS for all patients (n=50) were analyzed and also stratified based on disease type: CRC (n=12); NE (n=26); and non-CRC/non-NE (n=12).|||months||95% Confidence Interval|Median
1410582|NCT01177007|Secondary|Tumor Response by the European Association for the Study of the Liver (EASL) Criteria|"Efficacy as assessed by radiographic tumor response using EASL criteria at baseline up to 12 months post treatment.~Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions."|12 months|RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12). 7 out of the 50 patients were not analyzed due to lack of follow-up imaging.|||Participants|||Count of Participants
1410583|NCT01177007|Secondary|Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0|"Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, at 4 weeks post treatment, and subsequent 3 month intervals.~Complete Response (CR): Disappearance of all lesions targeted by Y90 Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by Y90 Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by Y90 Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD."|12 months|RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12).|||Participants|||Count of Participants
1410584|NCT01177007|Secondary|Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria|This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported.|Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter.|Analysis for TTP was not performed. In lieu of TTP, the PFS based on RECIST and EASL criteria was analyzed.||||||
1410585|NCT01177007|Primary|Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria|Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9.|2 years|Median PFS for all subjects and stratified based on disease type.|||months||95% Confidence Interval|Median
1410587|NCT01176968|Secondary|Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.|Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||pg/mL||Inter-Quartile Range|Median
1410588|NCT01176968|Secondary|Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.|Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||μg/L||Inter-Quartile Range|Median
1410589|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.|Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||ng/mL||Inter-Quartile Range|Median
1410590|NCT01176968|Secondary|Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.|Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|6 months|The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (carboxyterminal telopeptide of type I collagen [ICTP], procollagen type I N-terminal peptide [PINP], procollagen type III N-terminal peptide [PIIINP], Interleukin-6, aldosterone, cortisol, and Galactin 3) available.|||nmol/L||Inter-Quartile Range|Median
1410591|NCT01176968|Secondary|Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).|LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Centimeters (cm)||Standard Deviation|Mean
1410592|NCT01176968|Secondary|Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.|Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.|6 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Milliseconds (msec)||Standard Deviation|Mean
1410593|NCT01176968|Secondary|Second or Subsequent Non-fatal Myocardial Infarction (MI).|The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
1410594|NCT01176968|Secondary|Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).|The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Events|||Number
1410595|NCT01176968|Secondary|Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).|The occurrence of first occurrence of BNP >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for ages <50 years, 50 to 75 years and >75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.|||Events|||Number
1410596|NCT01176968|Secondary|First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).|The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.|||Events|||Number
1410633|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|Preoperative, 4-6 weeks||||degrees||Standard Deviation|Mean
1410743|NCT01175707|Secondary|Number of Intervention Types During Home Infusion Therapy|There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention.|Day 1 up to Day 14|All study participants|||participants|||Number
1410597|NCT01176968|Secondary|First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.|The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
1410598|NCT01176968|Secondary|Diagnosis of Heart Failure|The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
1410599|NCT01176968|Secondary|Cardiovascular Mortality|The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.|0-24 months|The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.|||Events|||Number
1410600|NCT01176968|Primary|First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off|Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease [PAD], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP >200 pg/mL or NT-proBNP >450 pg/mL (age <50 years); >900 pg/mL (age 50 to 75 years) or >1800 pg/mL (age >75 years) after 1 month.|0-24 months|The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.|||Events|||Number
1410601|NCT01176955|Secondary|The Measured Adherence by the MEMS Cap in Relation to the Change (Dynamic Assessment) in the Acne Global Assessment.|All study subjects' objective adherence will be compared to clinical improvement as measured by the Acne Global Assessment.|12 weeks||||Spearman's Rank Correlation Coefficient|||Number
1410602|NCT01176955|Secondary|The Change (Dynamic Assessment) From Baseline to End of Treatment in Lesion Counts.|Both inflammatory (papules, pustules and nodules) and non-inflammatory (open and closed comedones) acne lesions will be counted by a study investigator. Percentage change from baseline to the final study visit will be calculated.|Baseline to 12 weeks||||percent change in lesion count||Standard Deviation|Mean
1410603|NCT01176955|Secondary|The Change (Dynamic Assessment) in the Acne Global Assessment From Baseline to End of Study.|Acne Global Assessment is measured by a study investigator and is an overall assessment of the subject's acne severity, on a 0 (clear) to 5 (very severe) scale.|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1410604|NCT01176955|Primary|The Measured Adherence by the MEMS Cap in Relation to the Patient Reported Adherence Via the Internet Survey.|Adherence will be objectively measured with the Medication Event Monitoring System (MEMS) cap and the percentage of prescribed doses taken will be reported. Study subjects' self-reported adherence (in the intervention group, via the weekly internet survey) will be compared to objectively measured adherence via MEMS caps. Adherence was monitored objectively with electronic monitors that recorded the date and time when the medication containers were opened (medication event monitoring system caps). Adherence was rated as a percentage of days the medication container was opened; adherence could be greater than 100% if the container was opened more than once per day.|12 weeks||||percentage of days containers were open||Full Range|Median
1410605|NCT01176877|Secondary|To Assess the Impact of an Educational Lecture on Long-term Knowledge Retention About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and 3 Months After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|before and 3 months after a 5 minute educational lecture|Patients enrolled who were available for phone contact 3 months following intervention.|||score on a scale||Full Range|Mean
1410634|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (AUCt)|The PK properties (AUCt) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters.|||h*ng/mL||Standard Deviation|Mean
1410606|NCT01176877|Primary|To Assess the Impact of an Educational Lecture on Knowledge About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and Immediately After an Educational Lecture|All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.|immediately before and after a 5 minute educational lecture||||score on a scale||Full Range|Mean
1410607|NCT01176773|Secondary|Adverse Events||12 months|Intent-to-treat|||percentage of subjects|||Number
1410608|NCT01176773|Secondary|Number of Subjects Who Attain Their Lip Treatment Goal|"Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding yes as to whether their pre-established lip fullness treatment goal had been attained."|1-12 months|All subjects who provided a lip fullness goal achievement assessment|||percentage of subjects|||Number
1410609|NCT01176773|Secondary|Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale|The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result.|3 months|All subjects with a Look and Feel assessment|||percentage of subjects|||Number
1410610|NCT01176773|Secondary|Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale|Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated in their oral commissures|||units on a scale||Standard Deviation|Mean
1410611|NCT01176773|Secondary|Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale|Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.|12 months|All subjects who were treated for perioral lines|||units on a scale||Standard Deviation|Mean
1410612|NCT01176773|Primary|Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale|The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment|3 months|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
1410613|NCT01176617|Secondary|Detection of Actionable Events Resulting in Change of Clinical Care|Change of clinical care include initiation of previously discontinued and/or new anti-arrhythmic drugs, decision for repeat ablation, hospitalization for arrhythmias, discontinuation or reinitiation of atrio-ventricular nodal blocking agents, discontinuation or reinitiation af anticoagulation after ablation and/or decision to implant a pacemaker and/or defibrillator.|12 months|Participants were monitored for this end point regardless of the randomization strategy to ensure patient safety.|||Participants|||Count of Participants
1410614|NCT01176617|Primary|Arrhythmia Burden|The primary outcome will be arrhythmia recurrences (atrial fibrillation and/or other atrial arrhythmias) after atrial fibrillation ablation over the initial 6 months and one year post-ablation as detected by the implantable loop recorder versus the conventional monitoring strategy. Months 1- 6 patients were being monitored by CM and ILR and in months 6 - 12 they were randomized to either ILR or CM.|6 and 12 months|Some participants withdrew before completing the full 1 year of required follow-up. In the first 6 months all 38 of the remaining patients arrhythmia recurrence was assessed using CM and Reveal XT. Participants were randomized in this phase to either CM or Reveal XT arms.|||Participants|||Count of Participants
1410615|NCT01176565|Other Pre-specified|Any Serious Adverse Event Within the 90-day Study Period|The complete count of all subjects who experienced any serious adverse events throughout their participation in the trial was included in this tabulation. Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients. Potential relatedness to the study treatment was a required reporting element for all adverse events but was not considered in this count. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly. An Independent Oversight Committee (IOC) reviewed and adjudicated adverse event data.|From randomization through the 90 day visit (90 ± 14 days per protocol window; up to ± 30 days data is used) or until known death, withdrawal, or loss to follow-up.|Patients may have experienced more than one adverse event. This measure is designed to show the total count of any patients who experienced any type of serious adverse event, whether it was felt to be related to the study treatment or not, throughout the duration of their participation in the study.|||Participants|||Count of Participants
1410635|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (Cmax)|The PK properties (Cmax) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters|||ng/mL||Standard Deviation|Mean
1410636|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (Tmax)|The PK properties (tmax) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters|||hours||Standard Deviation|Mean
1410744|NCT01175707|Secondary|Mean Number of Interventions Per Participant During Home Infusion Therapy|Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw.|Day 1 up to Day 14|All study participants.|||Interventions||Standard Deviation|Mean
1410616|NCT01176565|Other Pre-specified|Treatment-related Serious Adverse Event Within 72 Hours of Randomization|Adverse events (AEs) and serious adverse events (SAEs) were assessed by the site investigators for all patients, including for their potential relatedness to the study treatment. An Independent Oversight Committee (IOC) reviewed and adjudicated all adverse event data. The 72-hours-from-randomization time window was considered the most likely time frame during which treatment-related adverse events or serious adverse events would be observed. Terminology from the Medical Dictionary for Regulatory Activities (MedDRA) and severity criteria from the Common Terminology Criteria for Adverse Events (CTCAE v. 4.03) were used as a basis for reporting adverse events. Serious adverse events are defined as being fatal, life-threatening, resulting in hospitalization or prolonged hospitalization, resulting in disability or congenital anomaly, or requiring intervention to prevent permanent impairment or damage and were required to be reported promptly.|From randomization through 72 hours (3 days)|Relatedness is defined by the terms unrelated, unlikely, possibly, probably, or definitely related to the study treatment. Results are entered as the count of participants experiencing any serious adverse event within 72 hours of randomization that was determined by the site investigator to possibly or more have relationship to the study treatment.|||Participants|||Count of Participants
1410617|NCT01176565|Other Pre-specified|Hypotension Within 72 Hours|Hypotension (abnormally low blood pressure) was the most likely adverse event that could be associated with the study treatment, and is the primary basis (risk) on which neurological deterioration or other untoward effects of the study treatment could occur. It is therefore examined as a numerically-measured occurrence in addition to monitoring patients closely for neurological deterioration or other symptoms. Hypotension, when named as an adverse event, was defined as the syndrome of low blood pressure with SBP < 85 mmHg. Instances of hypotension were to be avoided through close monitoring, and administration of fluid bolus for SBP < 110 mmHg. If hypotension did occur, it was to be reversed as quickly as possible through discontinuation of intravenous nicardipine and intravenous fluid administration, which can be accomplished readily in a variety of settings where patients with intracerebral hemorrhage are routinely housed during early hospitalization.|From randomization through 72 hours from randomization|Blood pressure including the potential for hypotension was monitored according to intensive care unit standards for ICH patients during early hospitalization. Blood pressure was monitored more closely during the 24-hour study period and at times when nicardipine (or other/secondary IV antihypertensive medications) were being titrated.|||Participants|||Count of Participants
1410618|NCT01176565|Other Pre-specified|Neurological Deterioration Within 24 Hours, Defined by a Decrease of 2 or More Points on the GCS Score or an Increase of 4 or More Points on the NIHSS Score From Baseline, Not Related to Sedation or Hypnotic-agent Use and Sustained for at Least 8 Hours.|Neurologic deterioration was measured using two scales. The Glasgow Coma Scale (GCS) score measures of level of consciousness in eye, motor, and verbal components. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movement, visual fields, facial palsy, movement in each limb, sensation, language & speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42, with 0 indicating normal function and higher scores indicating greater deficit severity. Neurological status was checked per ICU standards through 24 hours, recommended as hourly GCS and full assessment every 2 hours. NIHSS assessment at baseline and 24 +/- 3 hours was pre-specified. Assessments were added for suspected neurological change.|From randomization through the 24-hour treatment period|All subjects were assessed for neurological status regularly. Grid-estimated verbal scoring based on eye and motor scores was used for intubated patients so that GCS scores could be compared over time and was consistent across patients.|||Participants|||Count of Participants
1410619|NCT01176565|Secondary|Hematoma Expansion (Number of Patients With Hematoma Expansion of 33% or Greater Between the Baseline and 24 +/- 6 Hours Head CTs, as Measured by the Central Reader for Patients With Readable Scans for Both Time Points Submitted by Data Lock.)|Hematoma expansion as determined by serial CT scans: Hematoma expansion was defined as an increase in the volume of intraparenchymal hemorrhage of 33% or greater as measured by a central imaging analyst who was was unaware of the treatment assignments, clinical findings, and time points of image acquisition. The area of the hematoma was delineated by image analysis software with the use of density thresholds on each slice, followed by manual correction. To ensure accuracy and consistency of the readings, images were coded randomly and independently of subject numbers and manual correction was also done without awareness of treatment assignments, clinical findings, or time points of image acquisition. This data point is defined as being present (hematoma expansion of 33% or more was calculated between the baseline scan hematoma volume and the 24 +/- 6 hours hematoma volume measures at data analysis), meaning that hematoma expansion as defined must have occurred or it was not counted.|From the baseline head CT to the 24 +/- 6 hours from randomization head CT|Participants with readable head CTs at baseline and 24 +/- 6 hours from randomization (submitted before data lock) were analyzed. Hematoma expansion was only recorded as present if ≥ 33% volume increase was calculated. Scans done outside of time window + margin, submitted after data lock, or not readable in standard DICOM format could not be used.|||Participants|||Count of Participants
1410637|NCT01176266|Secondary|Pharmacokinetic (PK) Properties of Asfotase Alfa (Tlast)|The PK properties (tlast) of asfotase alfa|PK parameters were calculated using Week 6 study visit data. Week 6 study visit blood samples for PK testing were drawn pre-dose and 6, 12, 24, 32, and 48 hours post dose|[14 out of the total 69 subjects had provided sufficient concentration-time data for PK analysis and estimating the PK parameters]|||hours||Standard Deviation|Mean
1410638|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Tooth Loss|Effect of asfotase alfa treatment on tooth loss assessed by the proportion of patients who experienced tooth loss during the study|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Participants|||Count of Participants
1410639|NCT01176266|Secondary|Effect of Asfotase Alfa on Serum Parathyroid Hormone (PTH) - Change From Baseline to Last Obtained Value|Effect of asfotase alfa on serum PTH as measured by change from Baseline to last assessment for each patient|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||pmol/L||Full Range|Median
1410620|NCT01176565|Secondary|Quality of Life at 90 Days Using EuroQol (EQ) Measures: EQ-5D (EuroQol Five Dimension), Consisting of Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire and EQ VAS (EuroQol Visual Analog Scale) Scores|Standardized scales developed by the EuroQol Research Foundation were used as a secondary outcome measure in addition to the mRS scale score. The EQ-5D is a simple, standardized non-disease-specific instrument for describing and valuating health-related quality of life. The EQ-5D-3L questionnaire consists of 5 questions in 5 different domains and allows for responses from 1 (the best outcome) to 3 (the worst outcome) in each of five categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Total scores range from 5 to 15, with lower scores indicating better quality of life and a higher score indicating a worse quality of life. A second component of EuroQol outcome measurements is a printed 20 cm visual analogue scale (EQ VAS) that appears somewhat like a thermometer, on which a score from 0 (worst imaginable health state or death) to 100 (best imaginable health state) is marked by the patient (or, when necessary, their proxy) with the scale in view.|90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization|All available valid data were analyzed. Outcomes collected outside of 90 ± 30 days weren't considered valid. EQ-5D data were missing for 28 patients in the intensive group & for 27 in the standard group. EQ VAS data were missing for 144 patients in the intensive group and for 146 in the standard group.|||units on a scale||Full Range|Median
1410621|NCT01176565|Primary|Death or Disability According to Modified Rankin Scale Score at 90 Days (3 Months) From Randomization|The primary outcome was death or disability, defined by modified Rankin scale (mRS) of 4-6 at 90 days following treatment. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death. A score of 4 indicates moderately severe disability including the inability to walk or attend to one's own bodily needs. A score of 5 indicates severe disability; bedridden, incontinent, and requiring constant nursing care. To score a 3 or lower on the mRS, a person must at least be able to walk without the assistance of another person. We chose the mRS because of its high inter-observer reliability, superiority to other indices, and consistency with previous trials in patients with ICH. Reliability was further increased by use of a structured interview template and by requiring mRS assessors to pass a certification test. Persons conducting the 90-day mRS assessment were to be unaware of the treatment arm or clinical course of the patients they assessed.|90 days (± 14 days per protocol window; up to ± 30 days data is used) from randomization|All subjects were analyzed for known death at any time following randomization. Patients surviving through 90 days (± 14 days per protocol window; data used up to ± 30 days) were assessed for disability using the mRS. Patients not completing the 90-day visit within 30 days of due date aren't included in the death & disability participant counts.|||Participants|||Count of Participants
1410622|NCT01176513|Secondary|To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.|Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.|After GE-148 (18F) Injection administration|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.||||||
1410623|NCT01176513|Primary|To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.|Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.|After GE-148 (18F) Injection administration.|Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.||||||
1410624|NCT01176448|Secondary|Visual Analog Scale for Assessing Scar Improvement.|"Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement~: 1-25% improvement~: 26-50% improvement~: 51-75% improvement~: 76-100% improvement"|3 months|"With 12 pairs of scars gave a 95% probability to detect a treatment difference at a two sided 0.05 significance level if a significant difference between treatments is 1.5 units (based on a 0~–4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units."|||units on a scale|Participants|Standard Deviation|Mean
1410625|NCT01176448|Primary|Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing|Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.|Day 0, Week1, Month 1|Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion.|||units on a scale|Participants|Standard Error|Mean
1410626|NCT01176435|Primary|Improved Vision|Binocular best-corrected visual acuity-The visual acuity test is used to determine the smallest letters you can read on a standardized chart (Snellen chart) or a card held 20 feet (6 meters) away. Special charts are used when testing at distances shorter than 20 feet (6 meters). Ranges are 20/10 vision to 20/200 vision. 20/10 being the best and 20/200 being the worse.|20 weeks||||logMAR||95% Confidence Interval|Mean
1410627|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|1 year||||degrees||Standard Deviation|Mean
1410628|NCT01176292|Primary|Clinical Flexion|Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.|4-6 months||||degrees||Standard Deviation|Mean
1410629|NCT01176292|Secondary|Oxford Knee Score|A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome.|1 year||||score||Standard Deviation|Mean
1410630|NCT01176292|Secondary|Knee Society Score|A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome.|1 year||||score||Standard Deviation|Mean
1410631|NCT01176292|Secondary|Radiographic Flexion|Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.|1 year||||degrees||Standard Deviation|Mean
1410640|NCT01176266|Secondary|Effect of Asfotase Alfa on Biomarkers - Plasma Pyridoxal-5' Phosphate (PLP) Change From Baseline to Last Obtained Value|Effect of asfotase alfa on PLP as measured by change from Baseline to last assessment for each patient|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||ng/mL||Full Range|Median
1410641|NCT01176266|Secondary|Effect of Asfotase Alfa on Biomarkers - Plasma Inorganic Pyrophosphate (PPi) Change From Baseline to Last Obtained Value|Effect of asfotase alfa on PPi as measured by change from Baseline to last assessment for each patient|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||uM||Full Range|Median
1410642|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Physical Growth - Weight Z-scores Change From Baseline to Last Obtained Value|Effect of asfotase alfa treatment on physical growth as measured by change from Baseline to last assessment for each patient in weight Z-scores|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Z-score||Full Range|Median
1410643|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Physical Growth - Length/Height Z-scores Change From Baseline to Last Obtained Value|Effect of asfotase alfa treatment on physical growth as measured by change from Baseline to last assessment for each patient in length/height Z-scores|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Z-score||Full Range|Median
1410644|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Respiratory Function|Effect of asfotase alfa treatment on respiratory function as measured by the shift in proportion of patients requiring respiratory support at their last assessment compared with Baseline.|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Participants|||Count of Participants
1410645|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Ventilator-free Survival (Week 312)|For patients who were not on respiratory support at the time of enrollment, the Kaplan-Meier estimate of ventilator-free survival at the end of the study|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Patients on respiratory support at Baseline were excluded from the analysis.|||Probability|||Number
1410646|NCT01176266|Secondary|Effect of Asfotase Alfa Treatment on Skeletal Manifestations of Hypophosphatasia (HPP)|The effect of asfotase alfa treatment on skeletal manifestations of HPP (i.e., change in rickets severity) was measured by radiographs using a qualitative Radiographic Global Impression of Change (RGI-C) scale. Skeletal radiographs obtained at the patient's last assessment were compared with skeletal radiographs obtained before initiation of treatment. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP-associated rickets) to +3 (indicative of complete or near complete healing of HPP-associated rickets).|Up to 72 Months or regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||scores on a scale||Full Range|Median
1410647|NCT01176266|Primary|Safety and Tolerability of Repeated Subcutaneous (SC) Injections of Asfotase Alfa|Safety and tolerability of repeated subcutaneous (SC) injections of asfotase alfa for all treated patients was assessed by the number of patients with 1 or more treatment-emergent adverse event.|Up to 72 months or until regulatory approval in the country of residence. Patients received study drug for a median duration of 829.0 days, with a range from 6 to 2116 days (ie, from 0.9 week to 5.8 years).|Full Analysis Set|||Participants|||Count of Participants
1410648|NCT01176266|Primary|Effect of Asfotase Alfa Treatment on Skeletal Manifestations of Hypophosphatasia (HPP)|The effect of asfotase alfa treatment on skeletal manifestations of HPP (i.e., change in rickets severity) was measured by radiographs using a qualitative Radiographic Global Impression of Change (RGI-C) scale. Skeletal radiographs obtained at Week 24 were compared with skeletal radiographs obtained before initiation of treatment. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP-associated rickets) to +3 (indicative of complete or near complete healing of HPP-associated rickets).|From Baseline to Week 24|Full Analysis Set|||scores on a scale||Full Range|Median
1410649|NCT01176240|Post-Hoc|Study 306A: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1) From Baseline to Week 1|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|Last observation carried forward was used to impute missing values.|||units on a scale||Standard Deviation|Mean
1410650|NCT01176240|Secondary|306B Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|The primary analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.|||units on a scale||Standard Deviation|Mean
1410769|NCT01175590|Primary|Ocular Treatment Emergent Adverse Events|Ocular Treatment-Emergent Adverse Events on the Study Eye|At each visit - 7 days|Safety Population|||Events|Participants||Number
1410651|NCT01176240|Secondary|306B Efficacy: Rate of Patient Reported Falls|The average number of patient reported falls per week.|up to 10 weeks|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.|||falls per week||Standard Deviation|Mean
1410652|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 8 (Visit 7)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 8 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week 8|The analysis was defined as those patients who completed 8 week of dosing and completed the visit 7 (8 week) efficacy evaluation. Patients who did not have week 8 efficacy data were excluded from the analysis. Of note, 2 patients completed the 8 week double blind study, but did not complete the efficacy evaluations at the final visit.|||units on a scale||Standard Deviation|Mean
1410653|NCT01176240|Secondary|306B Efficacy: Change in Systolic Blood Pressure (SBP) Measurements Post Standing From Baseline to Week 1|Measure: Lowest standing systolic blood pressure reading of immediately post standing and 3 minutes post standing. Change: standing systolic blood pressure at Week 1 (Visit 4) minus standing systolic blood pressure at baseline. A positive score indicates an improvement in standing systolic blood pressure during the double-blind randomized phase relative to value at baseline.|Baseline, Week 1|One droxidopa patient did not complete the standing blood pressure measurements of the orthostatic standing test at visit 4 (one week of stable dosing)|||mmHg||Standard Deviation|Mean
1410654|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 4 (Visit 6)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 4 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week4||||units on a scale||Standard Deviation|Mean
1410655|NCT01176240|Secondary|306B Efficacy: Change in OHSA Item 1 From Baseline to Week 2 (Visit 5)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 2 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week2||||units on a scale||Standard Deviation|Mean
1410656|NCT01176240|Post-Hoc|306A Efficacy: Patient Reported Falls|The total number of patient reported falls during the 8 week treatment period|Baseline, Week 8||||total falls per group|||Number
1410657|NCT01176240|Primary|306B Efficacy: Change in Dizziness/Lightheadedness/Feeling Faint/Feeling Like You Might Black Out (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at Week 1 minus score at baseline. A negative score indicates an improvement in symptoms during the double-blind randomized phase relative to value at baseline.|Baseline, Week1|The primary analysis was defined as those patients who completed 1 week of dosing at the identified optimal dose of study medication and completed the visit 4 (1 week) efficacy evaluation. Patients who did not have week 1 efficacy data were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1410658|NCT01176240|Primary|306A Efficacy: Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The primary efficacy endpoint for 306A is the relative mean change in Orthostatic Hypotension Questionnaire (OHQ) composite score from baseline to end of study. The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from baseline, negative numbers represent improvement from baseline in OHQ score."|Baseline, Week 8|LOCF was used to impute values for patients who did not have an end of study visit.|||units on a scale||Standard Deviation|Mean
1410659|NCT01176058|Secondary|Number of Participants Who Died||Baseline to Day 52|Safety population: All participants who have received at least one dose of study medication.|||participants|||Number
1410660|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at Follow-Up|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.|||percentage of participants||95% Confidence Interval|Number
1410661|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.|||percentage of participants||95% Confidence Interval|Number
1410662|NCT01176058|Secondary|Percentage of Participants With Microbiological Response at EOIT|Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure.|||percentage of participants||95% Confidence Interval|Number
1410663|NCT01176058|Secondary|Percentage of Participants With Clinical Response at Follow-Up|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|Post treatment follow-up visit (Up to Day 52)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.|||percentage of participants||95% Confidence Interval|Number
1410664|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.|||percentage of participants||95% Confidence Interval|Number
1410665|NCT01176058|Secondary|Percentage of Participants With Clinical Response at EOIT|Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.|End of Intravenous Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.|||percentage of participants||95% Confidence Interval|Number
1410666|NCT01176058|Secondary|Percentage of Participants With Global Response at End of Treatment (EOT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).~Failure – Any case that did not meet the criteria for success."|End of Treatment (Up to Day 42)|MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.|||percentage of participants||95% Confidence Interval|Number
1410667|NCT01176058|Primary|Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)|"Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response).~Failure – Any case that did not meet the criteria for success."|End of Intravenous Treatment (Up to Day 42)|Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.|||percentage of participants||95% Confidence Interval|Number
1410668|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Rate of Use of Added Antihypertensive Rescue Drugs|The rate of use of first and second antihypertensive rescue drugs added was also assessed at all visits after week 2. The rescue drug at week 10 and 18 for those patients not achieving the required BP was amlodipine, Patients who did not achieve the required BP at week 26 were treated with hydrochlorothiazide|Baseline, Week 10,18,26|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||Patients|||Number
1410669|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With SBP < 140 mmHg and DBP < 90 mmHg Compared to Baseline|The control rate was defined as the proportion of patients with SBP < 140 mmHg and DBP < 90 mmHg compared to baseline|Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||Patients|||Number
1410670|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Patients With Satisfactory Response Rate|Response rate was defined as the proportion of patients with a satisfactory systolic BP response (SBP < 140 mmHg or reduction of ≥ 10 mmHg compared to baseline) and a satisfactory diastolic BP response (DBP < 90 mmHg or reduction of ≥ 5 mmHg compared to baseline)|Baseline, Week10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||Patients|||Number
1410671|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Diastolic Blood Pressure (DBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||mmHg||Standard Deviation|Mean
1410672|NCT01176032|Secondary|Effectivness of Aliskiren in Controlling Blood Pressure Compare to Losartan in Terms of Reduction in Systolic Blood Pressure (SBP)|The mean systolic BP (SBP) and diastolic BP (DBP) readings for the aliskiren and losartan treatment groups, the difference in these values between the two groups and the comparison of post-baseline vs. baseline values|Baseline, Week 10,18,26,36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||mmHg||Standard Deviation|Mean
1410673|NCT01176032|Secondary|Change From Baseline of LVMI in Combination of Aliskiren With Amlodipine|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||g/m2||Standard Deviation|Mean
1410674|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||cm3/m^2||Standard Deviation|Mean
1410675|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||mm/m^2||Standard Deviation|Mean
1410676|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson) in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||Percent||Standard Deviation|Mean
1410677|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule in Combination of Aliskiren With Amlodipine|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ml||Standard Deviation|Mean
1410678|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease in Combination of Aliskiren With Amlodipine|The plasma level of biomarker parameter plasma aldosterone used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI).|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/dl||Standard Deviation|Mean
1410679|NCT01176032|Secondary|Change From Baseline in Combination of Aliskiren With Amlodipine in Biomarkers of Heart Disease.|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/ml||Standard Deviation|Mean
1410680|NCT01176032|Secondary|Change From Baseline in Reduction of Left Ventricular Mass Index (LVMI)|Echocardiogram was performed at week 1 and at week 36. Reduction in LVMI is defined as the difference between the LVMI at the final visit and the baseline LVMI|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment|||g/m^2||Standard Deviation|Mean
1410681|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, Left Atrial Volume (Biplane Simpson's Method)|Reductions in the following measurements were analysed between the baseline visit and the final visit: left atrial volume (biplane Simpson's method)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||cm3/m^2||Standard Deviation|Mean
1410682|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LA (Left Atrium) Diameter|Reductions in the following measurements were analysed between the baseline visit and the final visit: LA diameter|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||mm/m^2||Standard Deviation|Mean
1410683|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV Ejection Fraction (Teicholz), and LV Ejection Fraction (Simpson)|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV ejection fraction (Teicholz), and LV ejection fraction (Simpson)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||Percent||Standard Deviation|Mean
1410684|NCT01176032|Secondary|Change From Baseline in Left Ventricular (LV) Function, LV End-diastolic Volume by Simpson's Rule, and LV End-systolic Volume by Simpson's Rule|Reductions in the following measurements were analysed between the baseline visit and the final visit: LV end-diastolic volume by Simpson's rule, and LV end-systolic volume by Simpson's rule|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ml||Standard Deviation|Mean
1410703|NCT01175850|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class. Rutherford classification is a clinical staging system that is used to describe peripheral arterial disease.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of particpants|||Number
1410685|NCT01176032|Secondary|Change From Baseline in Biomarker Such as Aldosterone (Aldo) in Heart Disease|The plasma level of biomarker parameter (aldosterone (Aldo)) used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/dl||Standard Deviation|Mean
1410686|NCT01176032|Secondary|Change From Baseline in Biomarkers in Heart Disease|The plasma level of biomarkers parameters used to measure improvement in left ventricular (LV) function or reduction in left ventricular mass index (LVMI). The following biomarkers were analyzed: cardiotrophin-1 (CT-1), matrix metalloproteinase-1 (MMP-1); tissue inhibitor of MMPs (TIMP-1); annexin A5 (AnxA5); N-terminal prohormone of B-type natriuretic peptide (NT-proBNP)|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment. Patients with both baseline and week 36 assessment were included in this analysis.|||ng/ml||Standard Deviation|Mean
1410687|NCT01176032|Primary|Change From Baseline in C-terminal Propeptide of Procollagen Type I (PICP)|PICP is a measure of blood concentration of procollagen I carboxy-terminal propeptide (PICP), a peptide released from the myocardium when procollagen is converted to type I collagen. This biomarker exhibits good specificity and sensitivity for identifying myocardial fibrosis in hypertension.|Baseline, Week 36|Intention-to-treat (ITT) population included all patients included in the safety population who had a baseline assessment of the primary variable and at least one post-baseline assessment.|||ug/l||Standard Deviation|Mean
1410688|NCT01175902|Secondary|OPP, Period 2|"OPP was calculated according to the following formula:~OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP~OPP after treaemt from week 8 to week 12"|12 weeks||||mmHg||Standard Deviation|Mean
1410689|NCT01175902|Secondary|Ocular Perfusion Pressure (OPP), Period 1|"OPP was calculated according to the following formula:~OPP=(1/3 systolic BP + 2/3 diastolic BP) x 2/3 -IOP, diastolic OPP (DOPP)=diastolic BP-IOP"|4 weeks||||mmHg||Standard Deviation|Mean
1410690|NCT01175902|Primary|Blood Pressure (BP), Period 2|systolic and diastolic BP measured after treaemt from week 8 to week 12|12 weeks||||mmHg||Standard Deviation|Mean
1410691|NCT01175902|Primary|Blood Pressure (BP), Period 1|systolic and diastolic BP at 4 weeks after use of eyedrops|4 weeks||||mmHg||Standard Deviation|Mean
1410692|NCT01175902|Primary|Intraocular Pressure (IOP), Period 2|IOP (mean IOP) after treaemt from week 8 to week 12|12 weeks||||mmHg||Standard Deviation|Mean
1410693|NCT01175902|Primary|Intraocular Pressure (IOP), Period 1|IOP (mean IOP) after 4 weeks of treatment|4 weeks||||mmHg||Standard Deviation|Mean
1410694|NCT01175850|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Days||Standard Deviation|Mean
1410695|NCT01175850|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, stroke, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (ITT) (n=331)|||Percentage of participants|||Number
1410696|NCT01175850|Secondary|Procedural Success|Procedural success is defined as obtainment of ≤30% residual stenosis by visual estimate (with or without stenting)|Day 1|Intention-to-Treat (ITT) (n=331)|||Percentage of participants|||Number
1410697|NCT01175850|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).|||Percentage of devices|Devices||Number
1410698|NCT01175850|Secondary|Change From Baseline in Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ) at 12 Months|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.~Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
1410699|NCT01175850|Secondary|Change From Baseline in Quality of Life Assessment by EuroQol Group 5-Dimension Self Report Questionnaire (EQ5D) at Month 12|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.~EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|Baseline to 12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
1410700|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio >3.4).||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of particpants|||Number
1410701|NCT01175850|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4).|Duplex ultrasound measurement that measures the peak systolic velocity of blood (cm/sec) within a lesion divided by the peak velocity of blood (cm/sec) proximal to the lesion.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1410702|NCT01175850|Secondary|Secondary Sustained Clinical Improvement|Freedom from target limb amputation and increase in Rutherford class.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of participants|||Number
1410704|NCT01175850|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1410706|NCT01175850|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.|||Days||Standard Deviation|Mean
1410707|NCT01175850|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1410708|NCT01175850|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1410709|NCT01175850|Secondary|All-cause Death||12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||percentage of participants|||Number
1410710|NCT01175850|Secondary|Major Adverse Events (MAE) Composite|Major Adverse Events (MAE) composite defined as all-cause death, clinically-driven target vessel revascularization (CD-TVR), major target limb amputation, thrombosis at the target lesion site|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1410711|NCT01175850|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of Participants|||Number
1410712|NCT01175850|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4.|12 Month|Intention-to-Treat (ITT) (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
1410713|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
1410714|NCT01175824|Secondary|The Number of Participants With Severe Hypoglycemic Episodes|The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.|||participants|||Number
1410715|NCT01175824|Secondary|The Rate of Hypoglycemic Episodes|The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30.|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.|||hypoglycemic episodes per 30 day period||Standard Deviation|Mean
1410716|NCT01175824|Secondary|Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks|PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had PAM-D21 scores at 24 weeks.|||units on a scale||95% Confidence Interval|Least Squares Mean
1410717|NCT01175824|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks|ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×[(7-raw domain score)/6]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.|24 weeks|Randomized participants who received at least 1 dose of study drug and had ITSQ scores at 24 weeks. Last observation carried forward (LOCF).|||units on a scale||95% Confidence Interval|Least Squares Mean
1410718|NCT01175824|Secondary|The Number of Participants With a Hypoglycemic Episodes (Incidence)|A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of <= 70 milligrams per deciliter [mg/dL, 3.9 millimoles per liter (mmol/L)].|Baseline through 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug.|||participants|||Number
1410728|NCT01175811|Secondary|The Rate of Hypoglycemic Episodes|The rate of hypoglycemic episodes is defined as the mean number of hypoglycemic episodes per 30 days per participant. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.|||hypoglycemic episode/30 days/participant||Standard Error|Mean
1410719|NCT01175824|Secondary|Change in Weight From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, 24 weeks|Safety population: randomized participants who took at least 1 dose of study drug and had evaluable body weight data at the specified time points.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
1410720|NCT01175824|Secondary|Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks||12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had dosing data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||international units (IU)||Standard Deviation|Mean
1410721|NCT01175824|Secondary|Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG glycemic variability data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||millimoles/liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1410722|NCT01175824|Secondary|7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|12 weeks, 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1410723|NCT01175824|Secondary|Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks|The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks, and 24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had fasting plasma glucose concentration data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1410724|NCT01175824|Secondary|Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks||24 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||participants|||Number
1410725|NCT01175824|Secondary|Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint|The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 12 weeks|Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at the 12 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
1410726|NCT01175824|Primary|Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)|The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.|Baseline, 24 weeks|Per protocol population: randomized participants with the exception of participants who did not complete Week 24 visit, received study drug different from their randomized study treatment, violated any of the inclusion, exclusion, or discontinuation criteria, or were significantly noncompliant.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
1410727|NCT01175811|Secondary|Percentage of Participants Experiencing a Severe Hypoglycemic Episode|Severe hypoglycemic episode is defined as any event requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The percentage of participants experiencing a severe hypoglycemic episode is defined as the 100 multiplied by the number of participants experiencing a severe hypoglycemic episode divided by the number of participants exposed to study drug.|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.|||Percentage of participants|||Number
1410780|NCT01175434|Secondary|Feasibility and Acceptability|We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.|one year|||||||
1410729|NCT01175811|Secondary|Percentage of Participants With Hypoglycemic Episodes (Incidence)|Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to study drug. Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).|baseline through 24 weeks|Participants in the safety analyses population: participants who had been randomized and received at least one dose of study drug.|||percentage of participants|||Number
1410730|NCT01175811|Secondary|Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.|||International Units per kilogram (IU/kg)||Standard Deviation|Mean
1410731|NCT01175811|Secondary|Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) using change from baseline in BMI at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline BMI value as a covariate and participants as a random effect.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had baseline and at least 1 post-baseline BMI data.|||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
1410732|NCT01175811|Secondary|Daily Dose of Insulin: Total, Basal, and Prandial||24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug. Last observation carried forward (LOCF) principle was used.|||International Units (IU)||Standard Deviation|Mean
1410733|NCT01175811|Secondary|The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.|7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour [3 am]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24.|Baseline, 12 weeks, and 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1410734|NCT01175811|Secondary|The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks|The Percentage of participants achieving a haemoglobin A1c (HbA1c) less than or equal (<=) to 6.5% or 7% is defined as 100 multiplied by the number of participants with a HbA1c of the cut-off value (6% or 7%) divided by the number of participants exposed to study drug. Participants with missing HbA1c values at endpoint were treated as not achieving the HbA1c goal.|12 weeks, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study.|||Percentage of participants|||Number
1410735|NCT01175811|Secondary|Change in HbA1c From Baseline to 12 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 12 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and who had a baseline and at least 1 post-baseline evaluable HbA1c data.|||percent HbA1c||95% Confidence Interval|Least Squares Mean
1410736|NCT01175811|Primary|Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint|Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.|Baseline, 24 weeks|Participants in the intent-to-treat population: participants who had been randomized and received at least one dose of study drug and had at least 1 post-baseline evaluable HbA1c data.|||percent HbA1c||95% Confidence Interval|Least Squares Mean
1410737|NCT01175798|Secondary|Change in Immune Parameters|Secondary outcomes to be measured include change in peripheral blood mononuclear cell (PBMC) profile by flow cytometry at 6 and 12 months, change in ELISPOT-based panel of reactive T cell (PRT) readout at 6 and 12 months, change in PMBC cytokine production in response to toll-like-receptor stimulation at 6 and 12 months, and response to influenza vaccination.|1 year|||||||
1410738|NCT01175798|Primary|Change in 25OH-Vitamin D Level|Vitamin D deficient study subjects will be randomized to either treatment with 50,000 IU oral 25OH-Vit D weekly or no treatment (standard of care). The primary outcome of change in 25OH-Vit D level will be measured at 6 weeks, 3 months, 6 months, and 12 months.|1 year||||ng/dL||Inter-Quartile Range|Median
1410739|NCT01175707|Secondary|Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant|Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.|Day 1 up to Day 14|All study participants.|||US Dollars||Standard Deviation|Mean
1410740|NCT01175707|Secondary|Number of Laboratory Assessment Types During Home Infusion Therapy|There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough|Day 1 up to Day 14|All study participants.|||Assessments|||Number
1410741|NCT01175707|Secondary|Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.|Day 1 up to Day 14|All study participants.|||Assessments||Standard Deviation|Mean
1410742|NCT01175707|Secondary|Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy|Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.|Day 1 up to Day 14|All study participants.|||Participants|||Number
1410956|NCT01174446|Secondary|Total Weight-adjusted Dose Per Bleeding Episode (BEs) of All BEs Treated With BAX326 by Bleeding Site and Cause||Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set|||IU/kg|Bleeding Episodes|Inter-Quartile Range|Median
1410745|NCT01175707|Secondary|Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy|Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.|Day 1 up to Day 14|All study participants.|||Participants|||Number
1410746|NCT01175707|Primary|Percentage of Treatment Goals Met at End of Therapy|"Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic.~Each participant’s percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants’ percentage of goals met by arm."|Day 1 up to Day 14|All study participants.|||Percentage of Goals Met||Standard Deviation|Mean
1410747|NCT01175707|Primary|Reasons for Pharmacist Consultations During Home Infusion Therapy|The reason for a participant’s pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.|Day 1 up to Day 14|All study participants.|||Reason Cited|||Number
1410748|NCT01175707|Primary|Reasons for Nurse Visits During Home Infusion Therapy|The reason for a participant’s nurse visit is presented. There may be more than one reason for nurse visits per participant.|Day 1 up to Day 14|All study participants.|||Reason Cited|||Number
1410749|NCT01175707|Primary|Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy||Day 1 up to Day 14|All study participants.|||Participants|||Number
1410750|NCT01175707|Primary|Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy||Day 1 up to Day 14|Number of Participants Analyzed based on number of participants with at least one nurse visit/pharmacist consultation within each treatment group results in 39 participants analyzed for the Daptomycin ARM group for this Outcome Measure.|||Participants|||Number
1410751|NCT01175707|Primary|Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy|Each participant is counted once per category.|Day 1 up to Day 14|All study participants.|||Visits or Consultations per Participant||Standard Deviation|Mean
1410752|NCT01175707|Primary|Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy|The mean duration in home-infusion antibiotic therapy per participant is presented.|Day 1 up to Day 14|All study participants.|||Days||Standard Deviation|Mean
1410753|NCT01175707|Primary|Time Spent (Minutes) for Home Infusion Therapy|Each participant is counted once per category. Avg=average; Admin=administer.|Day 1 up to Day 14|All study participants.|||Minutes||Standard Deviation|Mean
1410754|NCT01175668|Secondary|Total Dose of NMS Used||For the duration of treatment, upto 3 months||||mg/kg||95% Confidence Interval|Mean
1410755|NCT01175668|Primary|Length of Treatment With Neonatal Morphine Sulfate||subjects were followed for the duration of treatment, up to 3 months||||days||95% Confidence Interval|Mean
1410756|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
1410757|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
1410758|NCT01175590|Secondary|Individual Clinical Outcomes - Bulbar Injection|Bulbar conjunctival injection measured as normal, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
1410759|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 11 (Vist 3)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
1410760|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 8 (Vist 2)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
1410761|NCT01175590|Secondary|Individual Clinical Outcomes - Ocular Discharge|ocular conjunctival discharge measured as absent, mild, moderate or severe|At day 1 (Vist 1)|Baseline-Designated Study Eye (Modified Intent-to- Treat Population)|||eyes|Participants||Number
1410762|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 11 (Visit 3)|Modified Intent-to-Treat Population|||eyes|Participants||Number
1410763|NCT01175590|Secondary|Microbial Outcome With Clinical Resolution|At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline|Day 8 (Visit 2)|Modified Intent-to-Treat Population|||eyes|||Number
1410764|NCT01175590|Primary|Non-Ocular Treatment-Emergent Adverse Events|Non-Ocular Treatment-Emergent Adverse Events on the Study Eye|7 days|Safety Population|||Events|||Number
1410765|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 11 (Visit 3)|Study Eye, Modified Intent-to-Treat Population|||eyes|Participants||Number
1410766|NCT01175590|Secondary|Microbial Eradication|The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.|Days 8 (Visit 2)|Study Eye, Modified Intent-to-Treat Population|||eyes|Participants||Number
1410767|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.|Day 11 (Visit 3)|Study eye for the mITT population|||eyes|||Number
1410768|NCT01175590|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data|Day 8 (Visit 2)|Study eye for the mITT population|||eyes|Participants||Number
1410770|NCT01175473|Secondary|Percentages of Patients by Ranges of Oxyntomodulin Levels|Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population. Here, 'n' signifies patients with oxyntomodulin assessment at the specified time point.|||percentage of participants|||Number
1410771|NCT01175473|Secondary|Change From Time-matched Baseline in Obestatin Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.|||nmol/L||Standard Deviation|Mean
1410772|NCT01175473|Secondary|Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28|Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment.|0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28|PD population.|||pmol/L||Standard Deviation|Mean
1410773|NCT01175473|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29|Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1).|Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)|PD population. Here, number of patients analyzed = patients with post-baseline HbA1c assessment.|||percentage of hemoglobin||95% Confidence Interval|Least Squares Mean
1410774|NCT01175473|Secondary|Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28|The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||h*pg/mL||95% Confidence Interval|Least Squares Mean
1410775|NCT01175473|Secondary|Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28|The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||h*ng/mL||95% Confidence Interval|Least Squares Mean
1410776|NCT01175473|Secondary|Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28|The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
1410777|NCT01175473|Secondary|Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28|The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||hour*micro international unit/milliliter||95% Confidence Interval|Least Squares Mean
1410778|NCT01175473|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28|PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|PD population.|||mg/dL||95% Confidence Interval|Least Squares Mean
1410779|NCT01175473|Primary|Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28|The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1.|0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28|Pharmacodynamic (PD) population (modified intent-to-treat [mITT] population) included all randomized patients, who received at least 1 dose of lixisenatide or liraglutide, and had both a baseline assessment and at least 1 post-baseline assessment of any pharmacodynamic variable, irrespective of compliance with the study protocol and procedures.|||h*mg/dL||95% Confidence Interval|Least Squares Mean
1410781|NCT01175434|Secondary|Cost Effectiveness|We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.|one year|||||||
1410782|NCT01175434|Primary|Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)|The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver.|Average number of days, over 2 weeks, throughout the school year||||Days||Standard Deviation|Mean
1410783|NCT01175395|Secondary|To Determine the Number of Retreatments With Lucentis in Eyes Initially Treated With 20089 TA and Lucentis|Because of the combination - 20089/Lucentis - treatment, patients may not require monthly Lucentis injections as is the current standard of care practice for AMD.|30 to 360 days||||retreatments||Full Range|Median
1410784|NCT01175395|Primary|To Assess the Safety & Tolerability of 20089 TA (6.9 mg or 13.8 mg) When Used Adjunctively With Lucentis 0.5 mg in Subjects With Sub-foveal Neovascular AMD|"The primary objective is to assess the ocular safety of 20089 TA (6.9 mg or 13.8 mg)treatment in combination with Lucentis.~The ocular safety endpoints to be assessed include the number of participants with ocular Adverse Events such as: evidence of endophthalmitis, uveitis, ocular hemorrhage, retinal tear or detachment to be assessed during ophthalmic examinations. Elevated IOP as measured by an applanation tonometer at every visit."|360 Days||||Number-participants with adverse events|||Number
1410785|NCT01175382|Secondary|Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)|Change from Baseline to 12 weeks on the International Prostate Symptom Score (I-PSS) to measure urinary symptoms related to BPH. The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|From Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1410786|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)|Change from baseline to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|From Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1410787|NCT01175382|Secondary|Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination|From Baseline to 12 weeks||||voids per day||Standard Deviation|Mean
1410788|NCT01175382|Secondary|Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|From Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1410789|NCT01175382|Secondary|Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia|From Baseline to 12 weeks||||voids per night||Standard Deviation|Mean
1410790|NCT01175382|Secondary|How Bothersome Were Side Effects? 12 Week Report|Ordinal Rating regarding how bothersome side effects were|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
1410791|NCT01175382|Secondary|Satisfaction With Progress at 12 Weeks|Patient global ratings of satisfaction using the validated Patient Satisfaction Question.|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
1410792|NCT01175382|Secondary|Patient Perception of Improvement at 12 Weeks|Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement.|12 weeks post randomization|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
1410793|NCT01175382|Secondary|Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)|Change from 6 weeks to 12 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to BPH.The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|Change from 6 weeks to 12 weeks||||units on a scale||Standard Deviation|Mean
1439877|NCT00936663|Other Pre-specified|AUC for Insulin|Area Under the Curve for insulin after OGTT|1 year||||mciu*hr/ml||Standard Deviation|Mean
1410794|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)|Change from 6 weeks to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|Change from 6 week to 12 weeks||||units on a scale||Standard Deviation|Mean
1410795|NCT01175382|Secondary|Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia|Change from 6 weeks to 12 weeks||||Voids per night||Standard Deviation|Mean
1410796|NCT01175382|Secondary|Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.|Change from 6 weeks to 12 weeks||||Episodes per week||Standard Deviation|Mean
1410797|NCT01175382|Secondary|Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|Change from 6 weeks to 12 weeks||||units on a scale||Standard Deviation|Mean
1410798|NCT01175382|Secondary|How Bothersome Were Side Effects? 6 Week Report|Ordinal Rating regarding how bothersome side effects were|From Baseline to 6 weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
1410799|NCT01175382|Secondary|Patient Perceptions of Improvement|Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement|From Baseline to 6 Weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
1410800|NCT01175382|Secondary|Patient Satisfaction|Patient global ratings of satisfaction using the validated Patient Satisfaction Question|From Baseline to 6 Weeks|Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis).|||Participants|||Count of Participants
1410801|NCT01175382|Secondary|Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)|Change from baseline to 6 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to benign prostatic hypertrophy (BPH). The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).|From Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
1410802|NCT01175382|Secondary|Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)|Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.|From Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
1410803|NCT01175382|Secondary|Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia.|From Baseline to 6 Weeks||||voids per night||Standard Deviation|Mean
1410804|NCT01175382|Secondary|Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.|From Baseline to 6 Weeks||||episodes per week||Standard Deviation|Mean
1410805|NCT01175382|Secondary|Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)|Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.|From Baseline to 6 Weeks||||units on a scale||Standard Deviation|Mean
1410806|NCT01175382|Primary|Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination|Baseline to 12 weeks||||Voids per day||Standard Deviation|Mean
1410807|NCT01175382|Primary|Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination.|Change from 6 weeks to 12 weeks||||Voids per day||Standard Deviation|Mean
1410808|NCT01175382|Primary|Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)|Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination.|From Baseline to 6 Weeks||||voids per day||Standard Deviation|Mean
1410809|NCT01175369|Secondary|Additional Asthma Morbidity Outcomes|We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.|1-9 months (Monthly Follow-up assessments)|||||||
1410810|NCT01175369|Secondary|Cost Effectiveness of the Intervention|Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.|approximately 9 months (length of school year)|||||||
1410811|NCT01175369|Secondary|Cotinine Level|To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).|2 month and approximately 9 month (end of school year) follow-up assessments|||||||
1410812|NCT01175369|Primary|Number of Symptom Free Days|The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).|Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)||||Days||Standard Deviation|Mean
1410813|NCT01175356|Secondary|Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG|Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory.|Up to 6 weeks after course 5 of induction|Includes patients who received 131I-MIBG therapy.|||Participants|||Count of Participants
1410814|NCT01175356|Primary|Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy|Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%.|Up to day -6 of conditioning|Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not receive 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving Bu/Mel conditioning is receiving the first dose of planned Busulfan on Day -6 of conditioning.|||Percentage of participants||95% Confidence Interval|Number
1410815|NCT01175356|Primary|Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131|Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.|Up to 6 weeks after course 5 of induction|Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not continue onto 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving MIBG labeled with iodine-131 is receiving 131I-MIBG.|||Percentage of participants||95% Confidence Interval|Number
1410816|NCT01175343|Secondary|Impact of RO49097 on Ascitic Fluid Circulating Tumor Cells|Impact of RO49097 on ascitic fluid circulating tumor cells.|Up to 2 years|Data were not collected.||||||
1410817|NCT01175343|Secondary|Expression of Notch Biomarkers in Advanced Platinum Resistant Ovarian, Fallopian, and Primary Peritoneal Cancers.|An exploratory analysis for potential predictive biomarkers was performed on archival, paraffin-embedded tumor tissue for components of the Notch Pathway: Jagged-1 and NICD. The percentage of positive cells were scored into four categories: 0 (0%), 1 (1-33%), 2 (34-66%), and 3 (67-100%). The product of the intensity and percentage scores was used as the final score and classified as negative (0-4) or positive (5-9).|Up to 2 years|25 patients were assessed for Jagged-1 expression. 17 patients that were evaluable for response were assessed for NICD expression.|||Participants|||Count of Participants
1410818|NCT01175343|Secondary|Frequency and Severity of Adverse Events|Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 2 years|Adverse events analyzed include all serious adverse events (SAEs), and other (non-serious) treatment-related adverse events.There are 21 SAEs and 72 other (non-serious) adverse events.|||Adverse Events|Adverse Events||Count of Units
1410819|NCT01175343|Secondary|Overall Survival|Summary statistics, such as mean, median, counts and proportion, used to summarize the patients. Survival estimates computed using Kaplan-Meier method. Potential association between variables measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher’s exact tests and Wilcoxon rank sum tests may be substituted if necessary. Ninety-five percent confidence intervals will be constructed and selected results illustrated using figures and plots.|Up to 2 years|40 patients are evaluable for response.|||months||95% Confidence Interval|Median
1410820|NCT01175343|Secondary|CA125 Response Rate (GCIG Criteria)|"The CA-125 response rate is defined as the proportion of patients with a Gynecological Cancer Intergroup (GCIG) CA-125 response.~CA-125 response is defined as the moment CA-125 is reduced by 50% from the last pre-treatment level prior to start of therapy. The response must be confirmed and maintained with a consecutive CA-125 for at least 28 days."|Time from start of treatment to time of disease progression or death from any cause, whichever came first, assessed up to 2 years|There are 40 patients evaluable for response.|||Participants|||Count of Participants
1410821|NCT01175343|Secondary|Overall Response Rate|"Response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST 1.1).~Evaluation of Target Lesions:~Complete response (CR) - disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response (PR) - at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Evaluation of Non-Target Lesions:~Complete response (CR) - disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis)."|Time from start of treatment to time of disease progression or death from any cause, whichever came first, assessed up to 2 years||||Participants|||Count of Participants
1410953|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Weight-adjusted Consumption Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||IU/kg||Inter-Quartile Range|Median
1410822|NCT01175343|Primary|Four Cycle Progression-free Survival Rate|"Defined as the proportion of the study population that has not had tumor progression (symptomatic, RECIST progression, CA-125 progression) or died at the completion of the cycle four mark.~RECIST criteria for progressive disease (PD) in target lesions: >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. In non-target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.~CA-125 PD is based on the progressive serial elevation of serum CA-125 according to:~A) elevated CA-125 pretreatment & normalization of CA-125 or C) CA-125 in normal range pretreatment: CA-125 >= 2x ULN on 2 occasions.~B) elevated CA-125 pretreatment that never normalizes: CA-125 >= 2x nadir value on 2 occasions"|84 days (4 courses)||||Participants|||Count of Participants
1410823|NCT01175317|Secondary|Average Intraoperative CO2 Gap|"The CO2 gap (difference arterial pCO2 and pCO2 of the stomach lumen) reflects global intestinal perfusion status and is measured every 15 minutes intraoperatively and every 60 minutes during the first 8 hours postoperatively.~Intraoperative measurements were averaged per individual patient, producing the average intraoperative CO2 gap."|Average intraoperative CO2 gap||||kPa||Standard Deviation|Mean
1410824|NCT01175317|Primary|Peak Value of I-FABP|"Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma.~The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group."|1 hour postoperatively||||pg/mL||Standard Deviation|Mean
1410825|NCT01175226|Primary|Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire|Daily Change in WURSS-21 Severity Score Averaged over Days 2 to 4. The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.|Days 2-4|Intent-to-Treat Infected (ITT-I) Population - all randomized subjects who had a PCR positive result for rhinovirus from nasal swab on Days 1, 3, 5 and 7 with at least 1 post-baseline measurement of efficacy.|||Scores on a scale||Standard Error|Least Squares Mean
1410826|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||Percentage of infusions|Infusions||Number
1410827|NCT01175213|Secondary|Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (non-SAE) and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1410828|NCT01175213|Secondary|Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, Seriousness: Serious AE (SAE), non-serious AE (nsAE) and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
1410829|NCT01175213|Secondary|Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (“Related”)|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1410830|NCT01175213|Secondary|Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study (“Related”)|"Categories presented as adverse event (AE) type : Total, Local, Systemic including infections, Systemic excluding infections, and Severity (Mild, Moderate, Severe, Total).~All of these adverse events are non-serious AEs."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
1410831|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1410832|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1410871|NCT01175031|Secondary|Device-Detected Obstructed Airway Apnea Agreement|Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|762 Device Detected Apneas were detected.|||events|Participants||Number
1439878|NCT00936663|Other Pre-specified|AUC for Glucose|Area Under the Curve for glucose after OGTT|1 year||||mg*hr/dl||Standard Deviation|Mean
1410833|NCT01175213|Secondary|Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious adverse event; SAE- serious adverse event Severity: Mild; Mod (Moderate); Sev (Severe)~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1410834|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
1410835|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M).|"Categories presented as Preferred term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
1410836|NCT01175213|Secondary|Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Severity: Mild; Mod (Moderate); Sev (Severe)~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~Inc. - Increased Dis. - Disease"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs per participant|||Number
1410837|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z).|"Categories presented as Preferred Term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Infection - Inf."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs|||Number
1410838|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs|||Number
1410839|NCT01175213|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F).|"Categories presented as Preferred Term-Seriousness-Relatedness-Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relatedness to study drug: R (related to either study drug); NR (not related to either or both study drugs). Study drugs are Immune Globulin Subcutaneous Solution, 10% (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20) Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD - Attention Deficit/Hyperactivity Disorder COPD - Chronic Obstructive Pulmonary Disease~Other abbreviations:~CPK - Creatinine Phosphokinase Inc. - Increased Dis - Disease Sml- small"|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Data Set|||Number of AEs|||Number
1410840|NCT01175213|Secondary|Percentage of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.|||Percentage of participants|||Number
1410841|NCT01175213|Secondary|Number of Participants With AEs Related to Anti-rHuPH20 Titers||Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.|||Number of participants|||Number
1410842|NCT01175213|Secondary|Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.~This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).~In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20|||Percentage of participants|||Number
1410954|NCT01174446|Secondary|Consumption of BAX326 Per Participant: Median Number of Infusions Per Month||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week (Prophylaxis and On-Demand period), Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Infusions||Inter-Quartile Range|Median
1410843|NCT01175213|Secondary|Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20|"Participants who develop binding antibodies and/or neutralizing antibodies to recombinant human hyaluronidase (rHuPH20) from study 160603 and/ or from this study (160902) are included here.~This study (160902) is an extension of study 160603. Study 160603 was divided into 2 study epochs. In epoch 1 of study 160603 participants were treated with intravenous (IV) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%. In epoch 2 of study 160603 participants were treated with subcutaneous (SC) administration of IGSC, 10% after SC administration of rHuPH20. Only participants who completed study 160603 were eligible to be screened and enrolled in this study (160902).~In this study, participants started on same doses of IGSC, 10% and rHuPH20 that were used for the last infusions in epoch 2 of study 160603."|Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)|Participants from study 160603 and this study (160902) who have received at least one infusion of rHuPH20|||Number of participants|||Number
1410844|NCT01175213|Secondary|Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||Percentage of infusions|Infusions||Number
1410845|NCT01175213|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs||Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||Percentage of infusions|Infusions||Number
1410846|NCT01175213|Secondary|The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs|"Separated into age groups as described below and into related (related to either study drug) and not related (not related to either or both study drugs).~Study drugs are Immune Globulin Subcutaneous Solution (IGSC), 10% and recombinant human hyaluronidase (rHuPH20)."|Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.|Safety Analysis Set|||SAEs/year|||Number
1410847|NCT01175213|Primary|Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency|"Immunoglobulin (IgG) steady state trough levels were measured in relation to dose frequency by measuring in relation to treatment interval (2-, 3- or 4-week intervals).~Initially participants were administered subcutaneous (SC) infusions of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20) [or IV infusions of IGSC, 10% only] at the treatment intervals and dose determined by epoch 2 of study 160603 (3- or 4-week intervals).~After 3 treatment intervals (either 3- or 4- week intervals), participants changed to a 2-week treatment interval, if agreed with participant and investigator, with the dose adjusted to 1/2 of the 4-week dose or 2/3 of the 3-week dose, whichever was applicable. The rHuPH20 dose was adjusted relative to the new IGSC, 10% dose in order to achieve a dose ratio of 75 U/g IgG.~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set|||g/L||95% Confidence Interval|Median
1410848|NCT01175213|Primary|Annual Rate of All Infections|"Annualized rate of infections per participant as defined by MedDRA system organ class (SOC) infections and infestations.~The point estimate of the annual rate of all infections was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20|||Number of infections/year||95% Confidence Interval|Number
1410849|NCT01175213|Primary|Annual Rate of Serious Bacterial Infections|"The point estimate of the annual rate of validated acute serious bacterial infections (VASBIs) per participant per year was provided during subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10%, after SC administration of human recombinant hyaluronidase (rHuPH20).~This efficacy outcome measure was only applicable prior to the safety follow-up i.e. before discontinuation of rHuPH20."|Throughout the efficacy period only (from 60 to 729 days)|Safety Analysis Set excluding the 3 participants who were treated with intravenous (IV) administration of IGSC, 10% without rHuPH20|||Estimated infections/year|||Number
1410850|NCT01175148|Primary|Cummalative Incidence of Grade 2 to 4 Acute Graft vs Host Diesease (GVHD) at Day 100 Post Transplant in HSCT Recipients|Cummalative incidence of grade 2 to 4 acute Graft vs Host Diesease (GVHD) at day 100 post transplant will be will be histologically confirmed and graded in Hematopoietic Stem Cell Transplantation Recipients|100 days post transplant|Only the Recipients were analyzed for the outcome measurements.|||percentage of participants||95% Confidence Interval|Number
1410851|NCT01175135|Secondary|Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|"Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (Event code 3) (“Yes” on “aborted attempt”, “interrupted attempt”, “preparatory acts or behavior”), suicidal ideation (Event code 4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”). Number of participants with Yes response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement."|Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1410872|NCT01175031|Secondary|Device Detected Apneas as Detected by Philips Respironics (PR) System One|All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway.|During a single night of polysomnography lasting an average of 8 hours|1097 Device Detected Apneas were detected.|||events|Participants||Number
1410852|NCT01175135|Secondary|Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4|MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S * D * C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 [mild]; 2 [moderate]; 3 [severe]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.|Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1410853|NCT01175135|Secondary|Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4|ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.|Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
1410854|NCT01175135|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin|Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein [HDL], low-density lipoprotein [LDL], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c [HbA1c] and Prolactin).|Day 1 up to Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1410855|NCT01175135|Secondary|Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)|Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.|Day 1 up to Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure|||participants|||Number
1410856|NCT01175135|Secondary|Number of Participants With Laboratory Test Abnormalities|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: <0.9*LLN,>1.1*upper limit of normal (ULN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN)|Screening up to end of study (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1410857|NCT01175135|Secondary|Number of Participants With Clinically Significant Changes in Physical Examinations|Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed.|Screening, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1410858|NCT01175135|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)|Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett’s correction [QTcB] interval, and QT corrected using Fridericia’s correction [QTcF]).|Baseline up to end of study (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1410859|NCT01175135|Secondary|Change From Baseline in Abdominal Girth at Week 4||Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||centimeter (cm)||Standard Deviation|Mean
1410860|NCT01175135|Secondary|Change From Baseline in Body Weight at Week 4||Baseline, Week 4|Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||kilogram (kg)||Standard Deviation|Mean
1410861|NCT01175135|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Score|TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.|Week 4|FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1410862|NCT01175135|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4|GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.|Baseline, Week 4|FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1410863|NCT01175135|Secondary|Clinical Global Impression - Improvement (CGI-I) Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: “Compared to your subject’s condition at the beginning of treatment, how much has your subject changed?” Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1410864|NCT01175135|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4|PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1410865|NCT01175135|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4|PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1410866|NCT01175135|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. Clinician responded to a question “Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?” on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected.|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1410867|NCT01175135|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4|PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.|Baseline, Week 4|FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1410868|NCT01175135|Primary|Proportion of Participants With Dystonia Adverse Events|Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.|Baseline up to end of study (7 to 10 days after administration of last dose of study medication)|Safety analysis set included all participants who received at least 1 dose of study medication.|||proportion of participants|||Number
1410869|NCT01175135|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Week 4|Full analysis set (FAS) included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1410870|NCT01175031|Secondary|Device-Detected Clear Airway Apnea Agreement|Device Detected Clear Airways were broken down and then reviewed with the manually scored apneas. Of the clear airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored, hypopneas and manually scored RERAs.|During a single night of polysomnography lasting an average of 8 hours|335 Device Detected Clear Airway Apneas were detected.|||events|Participants||Number
1439879|NCT00936663|Secondary|Hypoglycemia|Number of episodes of hypoglycemia (blood glucose less than 70 mg/dl)|1 year||||episodes||Standard Deviation|Mean
1410873|NCT01175031|Primary|Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography|The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared.|During a single night of polysomnography lasting an average of 8 hours||||events/hour||Standard Deviation|Mean
1410874|NCT01175018|Secondary|Number of Adverse Events Requiring Withdrawal in Each Group||10-14 weeks||||adverse events|||Number
1410875|NCT01175018|Secondary|Number of Deaths in Each Group||10-14 weeks||||deaths|||Number
1410876|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%||10-14 weeks||||% of participants|||Number
1410877|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%||10-14 weeks||||% of participants|||Number
1410878|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)||10-14 weeks||||% of participants|||Number
1410879|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.|||% of participants|||Number
1410880|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)||10-14 weeks||||% of participants|||Number
1410881|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks||10-14 weeks||||(no units; ratio of values)||Inter-Quartile Range|Median
1410882|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks||||% (absolute change)||Inter-Quartile Range|Median
1410883|NCT01175018|Secondary|Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)||10-14 weeks||||% (absolute change)||Inter-Quartile Range|Median
1410884|NCT01175018|Secondary|Number of Adverse Events in Each Group||10-14 weeks||||adverse events|||Number
1410885|NCT01175018|Secondary|Incidence of Heart Failure|Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure|10-14 weeks||||participants|||Number
1410886|NCT01175018|Secondary|Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks||10-14 weeks||||ml*kg^-1*min^-1||Inter-Quartile Range|Median
1410887|NCT01175018|Secondary|Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)||10-14 weeks||||% of participants|||Number
1410888|NCT01175018|Secondary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.|||mL/m2||Inter-Quartile Range|Median
1410889|NCT01175018|Primary|Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices|Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.|10-14 weeks minus baseline|Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.|||mL/m2||Inter-Quartile Range|Median
1410890|NCT01175005|Primary|Procalcitonin Level at ED Presentation|Level of procalcitonin will be obtained. At the end of the study we will determine who was septic or bacteremic and compare the procalcitonin levels between those who were septic/bacteremic and those who were not.We will attempt to identify whether a level of procalcitonin exists above which rates of bacteremia or bacterial sepsis in patients with fever and a central line exist. Blood cultures will be followed for up to 5 days until reported as final.There are no further study interventions.|Initial blood draw in ED and if admitted a second level will be obtained at 24 hours.||||ng/dL||95% Confidence Interval|Mean
1410891|NCT01174784|Primary|CTO Crossing Success Using the Wildcat|Successful femoropopliteal CTO crossing using the Wildcat identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.|||participants|||Number
1410892|NCT01174784|Primary|Major Adverse Events|The primary safety endpoint of the CONNECT Study was defined as absence of in-hospital or 30-days Major Adverse Events (MAEs), no evidence of clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Wildcat CTO crossing confirmed by angiography.|Index through 30-Day Follow-Up|Patients treated with Wildcat post guidewire failure.|||participants|||Number
1410893|NCT01174576|Primary|Total Energy Intake|the energy consumed at breakfast, ad libitum meal and rest of the experimental day|1 d||||kcal||Standard Deviation|Mean
1410894|NCT01174576|Primary|Energy ad Libitum Meal|The energy of first meal 3 hr after ingestion|3 hr post ingestion||||kcal||Standard Deviation|Mean
1410895|NCT01174576|Primary|Cortisol Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||ug*h/dL||Standard Deviation|Mean
1410896|NCT01174576|Primary|Insulin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||uU*h/ml||Standard Deviation|Mean
1410924|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haemo-QoL - Participants On-Demand (Ages 12-16)|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410897|NCT01174576|Secondary|Serum Antioxidant Capacity Total Area Under the Curve|"Serum samples, collected 15 min before ingestion, immediately after ingestion, 15 min, 30 min, 60 min, 90 min, 120 min and 150 min after ingestion were analyzed for the ex vivo serum resistance to oxidative stress, that was induced by copper sulfate (CuSO4). The analysis of all collected samples was performed by the measurement of conjugated diene formation, which was monitored for every sample of all time points every 2 min for a 3.5 h period at 234 nm in a microplate spectrophotometer.~Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150 min postconsumption."|15 min before ingestion to 21/2 hr post ingestion||||lag time (min) *h||Standard Deviation|Mean
1410898|NCT01174576|Primary|Glucose Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||mg*h/dl||Standard Deviation|Mean
1410899|NCT01174576|Primary|Interleukin-18 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||pg*h/mL||Standard Deviation|Mean
1410900|NCT01174576|Primary|Inteleukin-6 Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||pg*h/mL||Standard Deviation|Mean
1410901|NCT01174576|Primary|Adiponectin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 h post ingestion||||ug*h/mL||Standard Deviation|Mean
1410902|NCT01174576|Primary|Glucagon-like Peptide-1 (GLP-1) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||ug*h/mL||Standard Deviation|Mean
1410903|NCT01174576|Primary|Peptide Tyrosine Tyrosine (PYY) Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||pg*h/mL||Standard Deviation|Mean
1410904|NCT01174576|Primary|Ghrelin Total Area Under the Curve|Total area under the curve was defined as the sum of the areas under and over the baseline using the trapezoidal rule. The time points for the calculations were 15 min before beverage consumption, immediately after beverage consumption, 15, 30, 60, 90, 120, 150, 180 min postconsumption.|15 min before ingestion to 3 hr post ingestion||||ug*h/mL||Standard Deviation|Mean
1410905|NCT01174550|Secondary|Cumulative Radiation Exposure Within 90 Days|Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.|90 days||||milliSievert (mSv)||Inter-Quartile Range|Median
1410906|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing|Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing|6 month, 12 month 24 month|The number of participants were limited due to budget constraints.|||% of participants|||Number
1410907|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 months, 12 months, 24 months|The number of participants were limited due to budget constraints.|||participant score||Inter-Quartile Range|Median
1410908|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale|Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.|Baseline, 6 month, 12 month, 24 month|The number of participants were limited due to budget constraints.|||participant score||Inter-Quartile Range|Median
1410955|NCT01174446|Secondary|Consumption of BAX326 Per Event Per Participant|Weight-adjusted consumption of BAX326 by event per participant, i.e., for prophylactic treatment and for treatment of bleeds until resolution of bleed.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set|||IU/kg||Inter-Quartile Range|Median
1410909|NCT01174550|Secondary|Quality of Life (QOL) as Measured by Duke Activity Status Index|Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline, 6 months, 12 months 24 months|The number of participants were limited due to budget constraints.|||participant score||Inter-Quartile Range|Median
1410910|NCT01174550|Secondary|Medical Cost|Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.|90 days and 3 years cumulative|Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.|||Per participant cost in US dollars||95% Confidence Interval|Mean
1410911|NCT01174550|Secondary|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization|Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization|Up to 90 days following participant randomization||||Percentage of events||Standard Error|Mean
1410912|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
1410913|NCT01174550|Secondary|Time to Major Complications From Cardiovascular (CV) Procedures|Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
1410914|NCT01174550|Secondary|Time to Death or Myocardial Infarction (MI)|Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
1410915|NCT01174550|Secondary|Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization|Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
1410916|NCT01174550|Primary|Time to Primary Endpoint|Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.|90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months||||Percentage of participants with an event|||Number
1410917|NCT01174459|Secondary|Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)|International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.|after 12 months or at the end of observation|Efficacy set: The patient set included all patients in the safety set with approved indication RLS and had IRLS total score measurement at baseline and at least one post-baseline time point.|||Score on a scale||Standard Error|Mean
1410918|NCT01174459|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 Months|Safety set: all patients who were documented to have taken at least one dose of pramipexole except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.|||participants|||Number
1410919|NCT01174446|Secondary|Health Resource Use - Days Lost From Work or School||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Days||Full Range|Median
1410920|NCT01174446|Secondary|Health Resource Use - Unscheduled Doctor's Office Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Visits||Full Range|Median
1410921|NCT01174446|Secondary|Health Resource Use - Emergency Room Visits||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Visits||Full Range|Median
1410922|NCT01174446|Secondary|Health Resource Use - Total Days of Hospital Stay||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Days||Full Range|Median
1410923|NCT01174446|Secondary|Health Resource Use - Number of Hospitalizations||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||Hospitalizations||Full Range|Median
1410951|NCT01174446|Secondary|Occurrence of Total Binding Antibodies of Indeterminate Specificity (Within Assay Variability)|Occurrence of total binding antibodies of indeterminate specificity (within assay variability) to FIX, antibodies to CHO proteins and rFurin is defined by a dilution of 2 or less increase as compared to levels at screening visit (e.g. negative to 1:20 or 1:40).|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410925|NCT01174446|Secondary|Health-Related Quality of Life (HRQoL) Disease-specific: Haem-A-QoL|The Haem-A-QOL instrument has been developed and used in hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: physical health, sports/leisure, school/work, dealing with hemophilia, and outlook for the future. For the Haem-A-QOL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410926|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Total Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410927|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Psychosocial Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410928|NCT01174446|Secondary|Pediatric Quality of Life Questionnaire (PedsQL) Physical Health Summary Score (Ages 12-16)|The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 12 to 16-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410929|NCT01174446|Secondary|SF-36: HRQoL General Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410930|NCT01174446|Secondary|SF-36: HRQoL Social Functioning|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410931|NCT01174446|Secondary|SF-36: HRQoL Vitality|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410932|NCT01174446|Secondary|SF-36: HRQoL Mental Health|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410933|NCT01174446|Secondary|SF-36: HRQoL Bodily Pain|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410934|NCT01174446|Secondary|SF-36: HRQoL Role-Emotional|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410935|NCT01174446|Secondary|SF-36: HRQoL Role-Physical (RP)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1413504|NCT01153321|Secondary|Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes||up to 47 days (visit 1 to visit 6)||||Participants|||Number
1410936|NCT01174446|Secondary|SF-36: HRQoL Physical Functioning' (PF)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410937|NCT01174446|Secondary|SF-36: HRQoL 'Mental Health' (MH)|Quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410938|NCT01174446|Secondary|Short Form (36) Health Survey (SF-36): HRQoL 'Physical Component Score' (PCS)|The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410939|NCT01174446|Secondary|General Pain Assessment Through a Visual Analog Scale (VAS)|Participant rated assessment of health-related quality of life. The VAS Pain Scale rates current health state on a scale from 0 (no pain) to 100 (worst imaginable pain). For the pain scale, a higher score indicates worse pain.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410940|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions Visual Analogue Scale (EQ-5D VAS) Scores|Participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better quality of life.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410941|NCT01174446|Secondary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Total Index Scores|EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Baseline at either Study Part 1, or Study Part 2, and End of Study (study weeks 29-31)|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
1410942|NCT01174446|Secondary|Number of Participants With Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)||||participants|||Number
1410943|NCT01174446|Secondary|Number of Adverse Events (AEs) After BAX326 Treatment||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, and Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||adverse events|||Number
1410944|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Thrombogenic Markers|Clinically significant changes in thrombogenic markers assessments for thrombin-antithrombin (TAT), prothrombin fragment 1.2, and D-dimer as evaluated by an independent Data Monitoring Committee (DMC)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410945|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Vital Signs|Clinically significant changes in vital signs assessments for pulse rate, systolic/diastolic blood pressure, respiratory rate, body temperature|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410946|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Hematology|Clinically significant changes in hematology assessments for Basophils, Basophils/Leukocytes, Eosinophils, Eosinophils/Leukocytes, Erythrocyte Mean Corpuscular Hemoglobin Concentration, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Lymphocytes/Leukocytes, Monocytes, Monocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes, Platelets,|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410947|NCT01174446|Secondary|Number of Participants With Clinically Significant Changes in Laboratory Parameters: Clinical Chemistry|"Clinically significant changes in chemistry assessments for Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Bicarbonate, Bilirubin, Blood Urea Nitrogen, Chloride, Glucose, Potassium, Protein (Serum), Sodium.~Clinically Significant (CS) defined as:~1. The abnormal value constitutes an adverse event (AE) and,~2. The abnormal value is a symptom of or related to a disease that is already recorded as an AE in Case Report Form (CRF)."|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410948|NCT01174446|Secondary|Number of Participants Who Experienced Thrombotic Events||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410949|NCT01174446|Secondary|Number of Participants Who Experienced Severe Allergic Reactions (e.g. Anaphylaxis)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410950|NCT01174446|Secondary|Occurrence of Treatment Related Total Binding Antibodies|Occurrence of treatment related total binding antibodies to Factor IX (FIX), antibodies to Chinese hamster ovary (CHO) proteins, and recombinant furin (rFurin) is defined by more than 2-dilution increase as compared to levels at screening visit and confirmed specificity (e.g. negative to 1:80)|Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1410952|NCT01174446|Secondary|Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Study Part 1 = 2-4 weeks, Study Part 2 = 26 weeks ± 1 week, Study Part 3 = 1 week (Total = 29-31 weeks)|Full Analysis Set|||participants|||Number
1439880|NCT00936663|Secondary|eGFR|estimated glomerular filtration rate (eGFR) at 1 year|1 year||||mL/min/1.73 m²||Standard Deviation|Mean
1410957|NCT01174446|Secondary|Hemostatic Efficacy at Resolution of All Bleeding Episodes (BEs) Treated With BAX326 by Bleeding Site and Cause|"Rating Scale for Treatment of BEs (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|At bleed resolution throughout the study period of 22 months (Study Parts 1, 2, and 3)|Full Analysis Set|||Bleeding episodes|Bleeding episodes||Number
1410958|NCT01174446|Secondary|Bleeding Episodes Treated With 1, 2 or ≥3 Infusions of BAX326 by Bleeding Site and Cause|The number of bleeding episodes treated with 1, 2, or ≥3 infusions of BAX326 to achieve adequate hemostasis. Only infusions required until resolution of bleed were considered.|Study Part 2 = 26 weeks ± 1 week (Study Part 2 began at week 3-5)|Full Analysis Set|||Bleeding episodes|bleeding episodes||Number
1410959|NCT01174446|Secondary|Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326|ABR during prophylaxis (twice-weekly) in Part 2 was calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25. The treatment period on prophylaxis was defined as time between the first and the last prophylactic infusions and ABR on prophylaxis was calculated for participants who received a minimum of 3 months of prophylactic treatment with BAX326.|Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks)|Full Analysis Set - Prophylactic cohort|||Bleeds per year||Inter-Quartile Range|Median
1410960|NCT01174446|Secondary|Study Parts 1 and 3: Volume of Distribution at Steady State (Vss)|"Vss computed as CL·MRT.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||dL/kg||Inter-Quartile Range|Median
1410961|NCT01174446|Secondary|Study Parts 1 and 3: Half Life (T 1/2)|"Elimination phase half-life will be determined as ln2/ λz.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||Hour||Inter-Quartile Range|Median
1410962|NCT01174446|Secondary|Change in Incremental Recovery (IR) at 30 Minutes Over Time|The median changes in IR at 30 Minutes, calculated as the change in IR value from exposure day 1 (ED1).|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
1410963|NCT01174446|Secondary|Incremental Recovery (IR) at 30 Minutes Over Time|"IR at 30 Minutes was measured at the following time points during the study:~Part 1 or Part 2, Exposure Day (ED) 1. (If participant was present for Study Part 1, then ED 1 from Part 1 was used. If Participant entered study in Study Part 2, then ED 1 from Part 2 was used.)~Part 2: Week 5~Part 2: Week 13~Part 2 or Part 3: Week 26 (Week 26 of study participation)~Study Completion or Termination Visit"|0-30 minutes before infusion and 30 minutes post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
1410964|NCT01174446|Secondary|Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax)|"Defined as (Cmax - Cpre-infusion)/Dose, where maximum concentration (Cmax) will be determined as the highest concentration achieved within one hour after infusion.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 1 hour post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU/dL) / (IU/kg)||Inter-Quartile Range|Median
1410965|NCT01174446|Secondary|Study Parts 1 and 3: Clearance (CL)|"Computed as Dose/ AUC0-∞.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||dL/(kg·hr)||Inter-Quartile Range|Median
1410966|NCT01174446|Secondary|Study Parts 1 and 3: Mean Residence Time (MRT)|"Computed as Area under the moment curve 0-∞ (AUMC0-∞) / AUC0-∞- TI/2, where AUMC0-∞ will be determined in a similar manner as AUC0-∞ and TI represents infusion duration [hr]~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||Hour||Inter-Quartile Range|Median
1411001|NCT01174030|Secondary|CEA Success|"CEA success defined as 2-grade improvement on CEA.~Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.~Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema~/ Amost clear; slight redness~/ Mild erythema; definite redness~/ Moderate erythema; marked redness~/ Severe erythema; fiery redness"|Day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.|||participants|||Number
1410967|NCT01174446|Secondary|Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose)|"Defined as (AUC0-t + Ct)/ λz/ dose, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration. λz will be estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.~The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1."|0-30 minutes before infusion up to 72 hours post-infusion|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU·hr)/ dL/ (IU/kg)||Inter-Quartile Range|Median
1410968|NCT01174446|Primary|Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose|Computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R^2.|72 hours|"Pharmacokinetic Per Protocol Analysis Set (PKPPAS)~-Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations"|||(IU·hr/dL) / (IU/kg)||Inter-Quartile Range|Median
1410969|NCT01174342|Primary|Intraocular Pressure|Intraocular pressure during different stages of child delivery.|During child delivery|We included in the analysis all women completing vaginal delivery that had measurements of their intraocular pressure during most stages of labor.|||mm Hg||Standard Deviation|Mean
1410970|NCT01174264|Primary|Tmax Following Steady State Exposure for 14 Days|Time of maximum drug concentration.|24 hours||||hours||Standard Deviation|Mean
1410971|NCT01174264|Primary|AUC Following Steady State Exposure for 14 Days|Area under the curve from 0 to 24 hours.|24 hours|3 and 2 patients with missing data, respectively|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1410972|NCT01174264|Primary|Cmax Following Steady State Exposure for 14 Days|Maximum drug concentration over 24 hours.|24 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1410973|NCT01174264|Primary|Ctrough Following Steady State Exposure for 14 Days|Minimum blood concentration over 24-hour observation period. Blood sample collected at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 24 hours.|24 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1410974|NCT01174264|Primary|Tlag Following Single Dose of Drug|Time between drug administration and when it is first observed in the systemic circulation.|168 hours||||hours||Standard Deviation|Mean
1410975|NCT01174264|Primary|Tmax`Following Single Dose of Drug|Time of maximum drug concentration|168 hours||||hours||Standard Deviation|Mean
1410976|NCT01174264|Secondary|Objective Responses in Patients With Solid Tumors|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 30 days|2 patients in Arm I and 4 patients in Arm III were non-evaluable for response.|||participants|||Number
1410977|NCT01174264|Primary|AUC Following Single Dose of Drug|Area under the curve from 0-168 hours.|168 hours||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1410978|NCT01174264|Primary|Cmax Following Single Dose of Drug|Highest observed concentration over the 168 hour period. Blood samples were collected at j0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 24, 48, 120, and 168 hours.|168 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1410979|NCT01174238|Secondary|Increase From Nadir in the Sum of Maximum (18)F-FLT Uptake Values After Treatment Holiday|(18)F-FLT uptake values following a 7-day treatment holiday compared to the lower of Baseline or Day 14 value.|Baseline, Day 14, Day 20|Five patients completed both pre- and post-treatment (18)F-FLT PET scans; one patient had minimal (18)F-FLT uptake at baseline|||participants|||Number
1410980|NCT01174238|Secondary|Time to Progression (TTP)||within 7 days of odd cycles after cycle 1 for the duration of treatment, up to 12 cycles||||months||95% Confidence Interval|Median
1410981|NCT01174238|Secondary|Overall Survival (OS)|Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline until death or up to 24 months||||months||95% Confidence Interval|Median
1410982|NCT01174238|Secondary|Optimal Interval Between the End of Axitinib Therapy and Initiation of Chemotherapy|Optimal interval between the end of axitinib therapy and initiation of chemotherapy, as determined using FLT PET as a Radiological Biomarker information of Resumption of DNA Synthesis Following Axitinib Therapy.|Days 1, 14, 17, and 20 of cycle 1||||days|||Number
1410983|NCT01174238|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients with tumor size reduction, i.e. the sum of partial responses plus complete responses. Radiographic response was evaluated using RECIST criteria during every 21-day cycle of treatment.|Monthly during study treatment, up to 12 months|Two patients discontinued treatment due to toxicity within the first 3 weeks, prior to the first infusion of paclitaxel/carboplatin, and were considered to be evaluable for toxicity but not for response.|||percentage of patients|||Number
1410984|NCT01174186|Secondary|Assessment Group in Ankylosing Spondylitis (ASAS) Core Set for Clinical Practice|clinical measurements of inflammation in spondyloarthritis patients as described by the Assessment Group in Ankylosing Spondylitis (ASAS)|one year|||||||
1410985|NCT01174186|Secondary|Spondyloarthritis Consortium of Canada Score|Inflammation on MRI assessed by the Spondyloarthritis Consortium of Canada score and a Danish scoring method|one year|||||||
1410986|NCT01174186|Primary|Change in Intestinal Inflammation Measured by Faecal Calprotectin|"Feacal calprotectin is a protein and a marker of the degree of inflammation in the intestine, but not the site of inflammation.~We measured the level calprotectin continuously in each of the patients. Difference was inferred by repeated measurement ANOVA"|Baseline to 52 weeks|"15 patients in each group was included. 3 in the calprotectin negative group patients did not fulfill the entire study period (1 lost to follow-up, 2 withdrew consent).~Data analysed as last observation carried forward."|||mg/g||Inter-Quartile Range|Median
1413684|NCT01152385|Secondary|Percentage Change in High-density Lipoprotein Cholesterol (HDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
1410987|NCT01174186|Primary|Change Lewis Score Index|"Lewis' score describes the amount of inflammation seen optically by capsular endoscopy.~Gralnek et al. devised and validated the Lewis score index, based on three endoscopic parameters: villous edema, ulcer and stenosis/stricture. Using these parameters, the authors established a score range of 8–4,800 points where: LS < 135 reflects normal mucosal appearances, LS 135–790 mild mucosal inflammatory change and an LS value ≥790 moderate to severe mucosal inflammatory changes.~The patients had endoscopy performed at baseline and again after 20 weeks. The number of patients improving was compared to number of patients deteriorating"|20 weeks|Because endoscopy has a small risk for perforation. The study was designed so only patients with active inflammation at baseline had follow-up endoscopy performed. Because all patients with normal calprotectin levels had normal endoscopy, follow-up was only performed on this group of patients.|||units on a scale||Inter-Quartile Range|Median
1410988|NCT01174173|Secondary|Right Ventricular Hemodynamics|Mean pulmonary artery pressure was assessed invasively by right heart catheterization at the conclusion of the study to estimate right ventricular hemodynamics.|3 months|Analysis was performed on all participants who completed right heart catheterization at the conclusion of the study|||mm Hg||Standard Deviation|Mean
1410989|NCT01174173|Secondary|Absolute RV Longitudinal Strain|Change in absolute right ventricular (RV) longitudinal strain as assessed by exercise stress echocardiography with speckle-tracking echocardiography at baseline and conclusion of the study. An increase in exercise-induced change in RV longitudinal strain between baseline to conclusion of the study is indicative of improved RV function. If absolute RV longitudinal strain increases with exercise, that is a sign that the RV is working well. If absolute RV longitudinal strain decreases with exercise, that is a sign that the RV is not working well. Therefore, between baseline and conclusion of the study, if exercise-induced change in RV strain increases that means that the RV is working better at the conclusion of the study.|3 months|Analysis was performed on all participants who completed exercise stress echocardiography at baseline and conclusion of the study (month 3)|||percentage||Standard Deviation|Mean
1410990|NCT01174173|Secondary|RV Perfusion on Cardiac MRI|The majority of patients did not undergo cardiac MRI because it was difficult for the patients to tolerate the imaging study. Therefore, we were not able to assess change in RV perfusion.|3 months|||||||
1410991|NCT01174173|Primary|Improve Quality of Life|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The scores are averaged and transformed to a range of 0-100, in which higher scores reflect better health status and was performed at the conclusion of the study.|3 Months|Analysis was performed on the 8 participants who completed the KCCQ questionnaire at baseline and at the conclusion of the study (month 3)|||KCCQ Summary Score||Standard Deviation|Mean
1410992|NCT01174173|Primary|6-Minute Walk Test|Improve Exercise Capacity measured by 6-Minute Walk Test|3 Months|Analysis was performed in all participants who completed the study and had a 6-minute walk test at baseline and at the conclusion of the study.|||meters||Standard Deviation|Mean
1410993|NCT01174173|Primary|Improve Angina Symptoms|Assessed as average improvement in WHO Functional Class. The WHO Functional Class score ranges from 1 to 4, with higher scores indicating more impairment|3 months|Analysis was performed on all participants who completed as average change in WHO Functional class score from baseline to 3 months (Baseline, 3 months)|||units on a scale||Standard Deviation|Mean
1410994|NCT01174160|Primary|Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm|The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute|Within 90 minutes after first exposure||||participants|||Number
1410995|NCT01174082|Primary|The Rate of Partial Response(PR) and Complete Response(CR) in Patients Receiving DLI From an ID-specific Vaccinated Donor|PR defined as 50% reduction disease including serum monoclonal paraprotein and CR defined as absence of original monoclonal paraprotein in serum and urine.|DLI up to 5 years post DLI|The donor participant was to supply the cell product to manufacturer the vaccine. The donor has no disease and therefore cannot be analyzed for a response.|||Participants|||Count of Participants
1410996|NCT01174043|Other Pre-specified|Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts||Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12|||||||
1410997|NCT01174043|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater.|up to 15 months||||participants|||Number
1410998|NCT01174043|Secondary|Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission|The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells.|1 year after treatment discontinuation|All patients enrolled and received treatment|||months||Standard Deviation|Mean
1410999|NCT01174043|Primary|Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib|The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated.|3 months of treatment with erlotinib|All patients enrolled and received treatment|||percentage of participants||95% Confidence Interval|Number
1411000|NCT01174030|Secondary|PSA-5 Success|"Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.~PSA-5 success defined as 2-grade improvement on PSA-5.~Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness~/ Very mild redness~/ Mild redness~/ Moderate redness~/ Severe redness"|day 29|ITT population, LOCF when the data are missing at all four timepoints (i.e. Hours 3,6,9,12) LOCF method will be applied from the previous visit.|||participants|||Number
1411002|NCT01174030|Primary|Composite Success|"Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).~Each concentration/regimen was compared to its respective placebo control as part of the primary analysis."|Day 29|Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.|||participants|||Number
1411003|NCT01174004|Secondary|Motor Symptoms Change From Baseline (Negative = Improvement)|"Motor symptoms were measured using the change from baseline to Day 43 in the combined score of the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). The possible total score is 0 to 160 and a negative change in score indicates improvement.~Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5."|Study Days 1 and 43|This is the “Intent to Treat” population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date.|||Score on the UPDRS-II+III||95% Confidence Interval|Least Squares Mean
1411004|NCT01174004|Primary|Antipsychotic Efficacy|"Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson’s Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.~Analysis Method: Mixed Model Repeated Measures (MMRM)"|Each study visit (i.e. Days 1, 15, 29 and 43)|"This is the Intent to Treat population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment collected no later than 3 days after the last dose date."|||Score on the SAPS-PD scale||95% Confidence Interval|Least Squares Mean
1411005|NCT01173874|Secondary|Efficacy as Measured by Positive and Negative Syndrome Scale (PANSS)|"Total PANSS score with 30 items. Each item is rated 1-7 so the minimum Total PANSS score =30 and the maximum is 210. Anchors for each item are as follows, the higher values represent an increase in severity of symptoms:~Absent~Minimal~Mild~Moderate~Moderately severe~Severe~Extremely severe"|4-6 month period|Completed subjects|||units on a scale||Standard Deviation|Mean
1411006|NCT01173874|Secondary|Cognition as Measured by Cognitive Assessment Interview (CAI)|"Cognitive Assessment Interview was used to obtain information about cognitive functioning from both subject and an informant. Composite CAI scores were reported. Scale ranges from 1-7 with the following anchors:~Normal, no cognitive impairment~Borderline impairment~Mildly impaired~Moderately impaired~Markedly impaired~Severely impaired~Among the most extremely impaired"|4-6 month period|completed subjects with available completed CAI data. Numbers above are correct as not all completed subjects (Analysis Population Description) had completed CAI assessment available for analysis.|||units on a scale||Standard Deviation|Mean
1411007|NCT01173874|Primary|Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale|The UPSA-B assesses functional capacity to perform tasks similar to those in daily life. Raw scores are converted into scaled scores ranging from 0–100, with higher scores indicating better functional capacity.|4-6 month period|Completed subjects|||units on a scale||Standard Deviation|Mean
1411008|NCT01173874|Primary|Cognitive Function Measured by MCCB Composite Score|"The MATRICS Consensus Cognitive Battery (MCCB) will be used to assess cognitive function. The MCCB composite score is comprised of sub-scale measures of: a) working memory; b) attention and vigilance; c) verbal learning; d) visual learning; e) speed of processing; f) reason and problem solving; and g) social cognition. The MCCB takes 90 minutes or less to complete.~MCCB assessed 4 times: prestabilization (screening), randomization (after 6-8 weeks of lurasidone stabilization, prior to initial cognitive remediation), midpoint (after 20 cognitive remediation session), and study completion (final visit after 30 cognitive remediation sessions).~MCCB composite scores are reported as t-scores where a t-score = 50 is the population average. Every 10 points is one standard deviation. There is no range as scores are as far from population average."|4-6 month period|Completers|||units on a scale||Standard Deviation|Mean
1411009|NCT01173848|Primary|Subjects Achieving Normal Vitamin D Levels||within 24 weeks||||participants|||Number
1411010|NCT01173718|Secondary|Time to Potential Central Venous Catheter Removal|The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.|Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123|All subjects with unknown time to potential central venous catheter removal at the 6 month window were omitted from calculations|||days||Full Range|Median
1411011|NCT01173718|Secondary|Time to First Cannulation|The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.|Time of access placement to first cannulation, assessed up to one week|All subjects with unknown time to first cannulation at the 6 month window were omitted from calculations|||percentage of grafts|||Number
1411012|NCT01173718|Secondary|Time to Event Analysis (Cumulative Patency)|The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.|6 Months|All subjects with unknown time to event analysis (cumulative patency) status at the 6 month window were omitted from calculations|||percentage of participants||95% Confidence Interval|Number
1411013|NCT01173718|Secondary|Primary Unassisted Patency at 6 Months|The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.|6 Months|All subjects with unknown primary unassisted patency status at the 6 month window were omitted from calculations|||percentage of participants|||Number
1411014|NCT01173718|Primary|Freedom From Bleeding at 6 Months|Percentage of subjects free from both major and minor bleeding events, assessed at 6-months|6 Months|All subjects with unknown bleeding status at the 6 month window were omitted from calculations|||percentage of participants||95% Confidence Interval|Number
1411015|NCT01173718|Primary|Cumulative Patency at 6 Months|Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.|6 Months|All subjects with unknown cumulative patency status at the 6 month window were omitted from calculations|||percentage of participants||95% Confidence Interval|Number
1411016|NCT01173679|Secondary|Toxicities|Dasatinib may enhance the myelosuppression expected from fludarabine. This toxicity will be monitored with frequent CBC's. If after Day 21 of a cycle there is a grade 4 cytopenia, a dose reduction will occur in the next cycle of treatment, and that cycle cannot start until the ANC > 1,000 and the platelets > 25,000. There is also a risk for pleural effusions with dasatinib, but the risk will be low, since there is a break from dasatinib dosing on days 15-28 of each cycle. Nevertheless, if a grade 2 pleural effusion occurs, there will be a dose reduction in the next cycle of treatment.|2 years||||Participants|||Count of Participants
1411017|NCT01173679|Secondary|Progression-Free and Overall Survival|To describe the progression-free and overall surivial|2 years||||months||Inter-Quartile Range|Median
1411018|NCT01173679|Primary|Response Rate|To describe the response rate of complete response (CR) and partial response (PR) to treatment with this drug combination (SD=stable disease, PD=progressive disease)|2 years||||Participants|||Count of Participants
1411019|NCT01173653|Primary|Smoking Status at Follow up|Patients enrolled in this study were contacted via phone to assess smoking status. Smoking status was a self-report from each subject. Primary outcome measure is the smoking status of the enrollee at the time of follow-up contact. We calculated the percentage of participants who had stopped smoking at the 6 week follow-up period in each arm|6 weeks|Of subjects enrolled, 56 of the 109 subjects in the control arm and 49 of 90 subjects in the intervention arm were able to be contacted via phone and were willing to provide follow-up data for analysis of smoking status at the 6 week follow-up.|||percentage of participants|||Number
1411020|NCT01173601|Secondary|Pharmacokinetics: Plasma Concentrations of LY2216684|A validated bioanalytical assay was used to determine plasma LY2216684 concentrations.|1 week, 4 weeks, and 8 weeks|Participants exposed to LY2216684 with evaluable plasma concentration values. Samples with concentrations below the lower quantification limit (BQL) of the assay were treated as missing values for the analysis and samples with incomplete dosing information were not included in the pharmacokinetics assessment.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1411021|NCT01173601|Secondary|Change From Randomization to Week 8 in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1411022|NCT01173601|Secondary|Change From Randomization to Week 8 in Blood Pressure (BP)|Blood pressure (BP) measurements were collected when the participant was in a sitting position. Three measurements of sitting BP collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline value, treatment-by-visit and baseline value-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1411023|NCT01173601|Secondary|The Percentage of Participants Experiencing Treatment-Emergent Adverse Events as a Function of CYP2D6 Phenotype|Treatment-emergent adverse events (TEAEs) were events that first occurred or worsened during the treatment phase. CYP2D6 functional phenotype was classified as poor metabolizer (PM) or non-poor metabolizer (non-PM). The percentage of participants who reported the TEAE is presented for each phenotype classification. Only TEAEs for which there was a statistically significant treatment-by-SSRI therapy interaction were included: tinnitus and influenza. A summary of serious and other non-serious adverse events regardless of causality is located in the Report of Adverse Events module.|Through 8 weeks|All randomized patients who do not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||percentage of participants|||Number
1411024|NCT01173601|Secondary|Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411025|NCT01173601|Secondary|Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale|The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411033|NCT01173601|Secondary|Change From Randomization to Week 8 in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411026|NCT01173601|Secondary|Percentage of Treatment Emergent (TE) Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a 'yes' answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a 'yes' answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation and behavior are defined as TE if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related TE events by the total number of participants at risk, multiplied by 100%. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Randomization through 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
1411027|NCT01173601|Secondary|Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing the worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411028|NCT01173601|Secondary|Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a self-administered 16-item questionnaire that measures degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point, Likert scale (1=very poor and 5=very good). The total raw score is the sum of items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of maximum possible score||Standard Error|Least Squares Mean
1411029|NCT01173601|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items|The Sheehan Disability Scale (SDS) was completed by the participant and used to assess the effect of the participant's symptoms on their work (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit, and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411030|NCT01173601|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The experience subscale score was derived by taking the mean of Items 1 through 6, and the average score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411031|NCT01173601|Secondary|Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)|CGI-S measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411032|NCT01173601|Secondary|Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline item score, treatment-by-visit and baseline item score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411053|NCT01173211|Primary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 28 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 28 after vaccination||||participants|||Number
1411034|NCT01173601|Secondary|Percentage of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization up to Week 8|A greater than or equal to 50 percent improvement (that is, a decrease from baseline) in the MADRS total score was defined as response criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants meeting response criteria at last visit by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
1411035|NCT01173601|Secondary|Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit, and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1411036|NCT01173601|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement|A MADRS total score of less than or equal to 10 for at least 2 consecutive measurements, including the participant's last measurement, was defined as remission criteria at last 2 consecutive visits. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6 for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission at last 2 consecutive visits by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants with a baseline and at least one post-baseline value.|||percentage of participants|||Number
1411037|NCT01173601|Secondary|Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal 10 up to Week 8|A MADRS total score of less than or equal to 10 was defined as remission criteria. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6 for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Percentage of participants was calculated by dividing the number of participants who meet criteria for remission by the total number of participants analyzed, multiplied by 100%.|Randomization up to 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||percentage of participants|||Number
1411038|NCT01173601|Secondary|Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score|The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The impact subscale score was derived by taking the mean of Items 7 through 13 (applicable items only). Item 12 applied only to participants with a spouse or significant other, and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline subscale score, treatment-by-visit and baseline subscale score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411039|NCT01173601|Secondary|Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Scale|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Function Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411040|NCT01173601|Primary|Change From Randomization to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit and baseline score-by-visit.|Randomization, 8 weeks|All randomized participants who have non-missing values at the time of randomization and at least one post-randomization value.|||units on a scale||Standard Error|Least Squares Mean
1411041|NCT01173523|Secondary|Overall Survival|Overall survival estimated using Kaplan-Meier (KM) methods is defined as the time from study entry to death due to any cause or date last known alive.|Long-term follow-up for survival occurred every 4 weeks. As of this analysis, follow-up among survivors was a median (range) of 11.5 months (0.9-47.9).|The analysis dataset is comprised of treated patients.|||months||95% Confidence Interval|Median
1411380|NCT01170754|Secondary|BUN Level in mg/dl|BUN level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
1411042|NCT01173523|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) based on RECIST 1.1 criteria or death. Participants alive without evidence of PD were censored at the date of last adequate disease assessment. Per RECIST 1.1 for target lesions PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression is appearance of one or more new lesions and/or unequivocal progression on existing non-target lesions.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1411043|NCT01173523|Secondary|Overall Response Rate|The objective response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort.|The analysis dataset is comprised of all treated patients.|||percentage of participants||95% Confidence Interval|Number
1411044|NCT01173523|Primary|8-Week Progression-Free Rate|The 8-week progression free rate is defined as the percentage of participants achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria by the time of the first disease assessment (8 weeks). Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; and SD is neither sufficient decrease to qualify as PR nor sufficient increase to qualify as progressive disease (PD). PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. Response needed confirmation within 4 weeks. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment.|The analysis dataset is comprised of all treated patients.|||percentage of participants||95% Confidence Interval|Number
1411045|NCT01173471|Secondary|Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set|||mmHg||95% Confidence Interval|Least Squares Mean
1411046|NCT01173471|Secondary|Clinically Relevant Change in Intra-ocular Pressure After 4 Weeks of Treatment||Baseline to 4 weeks|Efficacy analysis set|||Participants|||Number
1411047|NCT01173471|Primary|Percentage Change in Mean Intra-ocular Pressure Compared With Baseline After 4 Weeks Treatment||Baseline to 4 weeks|Efficacy analysis set|||Percentage change||95% Confidence Interval|Least Squares Mean
1411048|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV in Cord Blood Collected at Time of Delivery.|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.|||participants|||Number
1411049|NCT01173211|Secondary|HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine in Cord Blood Collected at Time of Delivery|Cord blood was collected at delivery for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects from whom cord blood samples were collected at delivery from which valid results were reported are included.|||Titers||95% Confidence Interval|Mean
1411050|NCT01173211|Secondary|Number of Participants With a Maternal Serum HAI Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2010-2011 Inactivated TIV at Time of Delivery.|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.|||participants|||Number
1411051|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Maternal Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Blood was collected from all participants prior to vaccination as well as at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the titer was 40 or greater at delivery, or the Day 0 titer was greater than or equal to 10 and the titer was an increase by 4-fold or more at delivery.|Day 0 prior to vaccination and at time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.|||participants|||Number
1411052|NCT01173211|Primary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected from all participants prior to vaccination as well as 28 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 0 prior to and Day 28 after vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.|||participants|||Number
1411528|NCT01169311|Primary|Uneventful Creation of a Functional Staple Line at First Firing of Device|Successful creation of staple line at first firing of device during hemorrhoidopexy|about 20 minutes for procedure||||participants|||Number
1411054|NCT01173211|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 following vaccination|Subjects who received vaccination and contributed blood samples from which valid results were reported are included. One subject who did not meet eligibility criteria was not included.|||Titers||95% Confidence Interval|Geometric Mean
1411055|NCT01173211|Secondary|Maternal HAI GMT Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at Time of Delivery|Maternal blood was collected for HAI assay at time of delivery. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|At time of delivery|Subjects who contributed blood samples at delivery from which valid results were reported are included.|||Titers||95% Confidence Interval|Geometric Mean
1411056|NCT01173211|Secondary|Number of Participants With HAI Antibody Titer of 40 or Greater Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. Participants are counted if the titer at the timepoint is 40 or greater.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.|||participants|||Number
1411057|NCT01173211|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
1411058|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
1411059|NCT01173211|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
1411060|NCT01173211|Secondary|Number of Participants With 4-fold or Greater Serum HAI Antibody Titer Increases Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected from all participants at 180 days after vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 180 post vaccination titer was 40 or greater, or the Day 0 titer was greater than or equal to 10 and the Day 180 post vaccination titer was an increase by 4-fold or more.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.|||participants|||Number
1411061|NCT01173211|Secondary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2010-2011 Seasonal Influenza Trivalent Influenza Vaccine at 6 Months After Vaccination|Blood was collected for HAI assay at approximately Day 180 following vaccination. The HAI assay was conducted with the three antigens in the 2010-2011 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 180 (approximately 6 months after vaccination)|Subjects who received vaccination and contributed blood samples from which valid results were reported are included.|||Titer||95% Confidence Interval|Geometric Mean
1411062|NCT01173211|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|8 days after vaccination (Days 0-7).|All participants receiving the vaccination are included in the safety cohort.|||participants|||Number
1411063|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving vaccination are included in the safety cohort|||participants|||Number
1411064|NCT01173211|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.|||participants|||Number
1411529|NCT01169103|Primary|Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months|Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk|Baseline and 6 months||||ng/mL||Standard Deviation|Mean
1411065|NCT01173211|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|During the pregnancy and at the time of delivery|Pregnant participants receiving vaccination are included in this outcome measure.|||participants|||Number
1411066|NCT01173211|Primary|Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination|All participants receiving vaccination are included in the safety cohort|||participants|||Number
1411067|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy|An electrochemiluminescence immunoassay screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly immunoglobulin (Ig) category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNCT)category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing. TRT=treatment|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.|||participants|||Number
1411068|NCT01173120|Secondary|Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose|Immunogenicity Population, defined as all participants who received at least 1 dose of abatacept administered with the ACP who had at least one post Substudy Day 1 immunogenicity result available.|||participants|||Number
1411069|NCT01173120|Primary|Mean Temperature Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||degrees Celsius||Standard Deviation|Mean
1411070|NCT01173120|Primary|Mean Heart Rate Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||beats per minute||Standard Deviation|Mean
1411071|NCT01173120|Primary|Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||mm Hg||Standard Deviation|Mean
1411072|NCT01173120|Primary|Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy||ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||mm Hg||Standard Deviation|Mean
1411073|NCT01173120|Primary|Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
1411085|NCT01173055|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|baseline compared with 6 weeks of treatment|Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable. On the placebo, side one additional participant did not have data for this variable.|||units on a scale||Standard Deviation|Mean
1411086|NCT01173055|Secondary|Diffuse Noxious Inhibitory Control (DNIC) Effect at Baseline.|0-100 numerical rating scale. 0 on the numerical scale represents a better outcome. 100 represents a worse outcome.|Baselines measured at week 0 and week 9 after washout from first assignment to treatment|One participant did not complete this outcome measure.|||units on a scale||Standard Deviation|Mean
1411074|NCT01173120|Primary|Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
1411075|NCT01173120|Primary|Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
1411076|NCT01173120|Primary|Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy|BL=baseline; LLN lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: >3 g/dL decrease from BL; Hematocrit: <0.75*BL; Erythrocytes: <0.75*BL; Platelets: <0.67*LLN/>1.5*ULN, or if BL <LLN, use 0.5*BL/<100,000 mm^3; Leukocytes: <0.75*LLN/ >1.25*ULN, or if BL<LLN, use <0.8*BL/>ULN, or if BL>ULN, use >1.2*BL/<LLN; neutrophils+bands: <1.0*10^3 c/uL; eosinophils: >0.750*10^3 c/uL; basophils: >400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750*10^3 c/uL/ >7.50*10^3 c/uL.|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
1411077|NCT01173120|Primary|Number of Participants With AEs of Special Interest in the ACP Device Substudy|AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs including all infections, local injection reactions (prespecified), and systemic injection reactions (within 24 hours of dosing).|ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of subcutaneous abatacept administered via the ACP.|||participants|||Number
1411078|NCT01173120|Secondary|Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy|Trough levels of abatacept were evaluated based upon serum samples. Day 1 pharmacokinetics were based on exposure to the pre-filled syringes and did not reflect abatacept exposure via the ACP device.|Days 1, 29, 57, 85, 169, and 253 of ACP substudy|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP. Trough concentrations in participants who discontinued from the substudy were not summarized descriptively, but were included in the concentration listings.|||ug/mL||Standard Deviation|Geometric Mean
1411079|NCT01173120|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months|As-Treated Population, defined as all participants enrolled in ACP substudy who received at least 1 dose of SC abatacept administered via the ACP.|||participants|||Number
1411080|NCT01173055|Other Pre-specified|Change in fMRI Activation Patterns During N-back Procedure From Baseline to End of Treatment.||Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later|||||||
1411081|NCT01173055|Other Pre-specified|Change in Descending Pain Modulation From Baseline to End of Treatment (as Assessed by Changes in fMRI Brainstem Activation Patterns)||Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later|||||||
1411082|NCT01173055|Other Pre-specified|Change in fMRI Brain Activation Patterns During Pressure Stimulation From Baseline to End of Treatment||Baselines measured at week 0 and week 9 after washout from first assignment to treatment; treatment effect measures collected 6 weeks later|||||||
1411083|NCT01173055|Secondary|Change in Pain Tolerance From Baseline to End of Treatment|The primary outcome parameter is the change in pressure pain tolerance (maximum tolerated pressure) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|baseline compared wtih 6 weeks of treatment|Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.|||kg/cm^2||Standard Deviation|Mean
1411084|NCT01173055|Secondary|Pain Tolerance at Baseline|The primary outcome parameter is the pressure pain tolerance (maximum tolerated pressure) at pre-treatment baseline.|Baselines measured at week 0 and week 9 after washout from first assignment to treatment||||kg/cm^2||Standard Deviation|Mean
1411087|NCT01173055|Primary|Change in Pain Threshold From Baseline to End of Treatment.|The primary outcome parameter is the change in medium pressure pain threshold (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale) from baseline to end of treatment. Measured in kg/cm^2. Lower values represent a worse outcome.|baseline compared with 6 weeks of treatment|Of 17 participants who completed both sequences, data was analyzed for the 15 whose values for all measurement variables were usable.|||kg/cm^2||Standard Deviation|Mean
1411088|NCT01173055|Primary|Pain Threshold at Baseline|The primary outcome parameter is the medium pressure pain threshold at pre-treatment baseline (pressure that evokes a perceived pain intensity of 40-50 out of 100 on a numerical rating scale). Measured in kg/cm^2.|Baselines measured at week 0 and week 9 after washout from first assignment to treatment||||kg/cm^2||Standard Deviation|Mean
1411089|NCT01173029|Post-Hoc|Polygenic Risk Score|"Among all analyzed, four renin-angiotensin-aldosterone polymorphisms had statistical significance relating to composite endpoint.~They were: Angiotensinogen, renin, angiotensin II type 1 receptor and aldosterone synthase. Each polymorphism was arbitrarily weighted according to respective presentation in both alleles as follows: zero (low risk homozygosis), one (heterozygosis) and two (high risk homozygosis). In a following step, they were summed up for each subject, thus, creating a polygenic risk score.~The weights of the polymorphisms were, thus, defined:~Angiotensinogen: MM - zero, MT - one, TT - two~Renin: AA - zero, GA - one, GG - two~Angiotensin II type 1 receptor: CC - zero, AC - one, AA - two~Aldosterone synthase: CC - zero, TC - one, TT - two~The polygenic risk score value ranges from zero (all low risk polymorphisms in homozygosis) to eight (all high risk polymorphisms in homozygosis)."|up to 10 years|Subjects in both resistant systemic arterial hypertension and pseudo-resistant systemic arterial hypertension groups had their respective genetic background scored according to present rule.|||composite enpoint events|||Number
1411090|NCT01173029|Secondary|Composite of Acute Myocardial Infarctions and/or Strokes Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.~Evidence of clinically definite acute myocardial infarction (prolonged > 20min chest pain, not relieved by sublingual nitrate, ST-T segment deviation on 12-lead surface ECG, elevation of plasma troponin >0.2 ng/dL 6h following chest pain episode).~Death was considered to be related to the event if occurring up to 30 days after the acute event.~Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.~A post-hoc sampling procedure (power calculation) validated sample size."|||participants|||Number
1411091|NCT01173029|Primary|Strokes, Either Fatal or Nonfatal|"Evidence of clinically definite stroke (focal neurological deficits persisting for more than 24 hours) confirmed or not by non-investigational computerized tomography.~Death was considered to be related to the event if occurring up to 30 days after the acute event.~Assessment twice an year by active and direct contact to patients or relatives and review of medical records."|up to 10 years|"Number of participants was based on input demand at outpatient clinics. Those who provided provided consent for genetic testing were included.~A post-hoc sampling procedure (power calculation) validated sample size."|||participants|||Number
1411092|NCT01172938|Secondary|Number of Participants With Adverse Events During the Apremilast-Exposure Period|A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP) and no later than 28 days after the last dose of IP. An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Baseline to Week 260; median total exposure to Apremilast was 170 weeks|Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.|||participants|||Number
1411093|NCT01172938|Secondary|Number of Participants With Adverse Events During the Placebo-Controlled Period|A Treatment Emergent Adverse Event (TEAE) is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Week 0 to Week 16 for placebo participants who entered early escape at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)|Safety population included all participants who were randomized and received at least one dose of IP.|||participants|||Number
1411101|NCT01172938|Secondary|Change From Baseline in the FACIT-Fatigue Scale Score at Week 52|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1413685|NCT01152385|Secondary|Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
1411094|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411095|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411096|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 52|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411097|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 52|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411098|NCT01172938|Secondary|Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants|||Number
1411099|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411100|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 52|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411102|NCT01172938|Secondary|Change From Baseline in the DAS28 at Week 52|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1411103|NCT01172938|Secondary|Change From Baseline in the CDAI Score at Week 52|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1411104|NCT01172938|Secondary|Change From Baseline in the Dactylitis Severity Score at Week 52|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1411105|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value > 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1411106|NCT01172938|Secondary|Change From Baseline in the Patient Assessment of Pain at Week 52|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||mm||Standard Deviation|Mean
1411107|NCT01172938|Secondary|Percentage of Participants With a Modified PsARC Response at Week 52|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411108|NCT01172938|Secondary|Change From Baseline in the SF-36 Physical Functioning Domain at Week 52|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1411109|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.|||units on a scale||Standard Deviation|Mean
1413686|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 6.5%||at 4th month|The analysis population was prior to rescue treatment (FAS)|||Participants|||Number
1411110|NCT01172938|Secondary|Percentage of Participants With a ACR 20 Response at Week 52|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 52|The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.|||percentage of participants||95% Confidence Interval|Number
1411111|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411112|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411113|NCT01172938|Secondary|Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411114|NCT01172938|Secondary|Percentage of Participants Achieving a MASES Score of Zero at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411115|NCT01172938|Secondary|Percentage of Participants With a ACR 70 Response at Week 24|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411116|NCT01172938|Secondary|Percentage of Participants With an ACR 50 Response at Week 24|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1439881|NCT00936663|Secondary|HbA1c|HbA1c at 1 year|1 year||||percentage of glycated haemoglobin||Standard Deviation|Mean
1411117|NCT01172938|Secondary|Percentage of Participants With an ACR 70 Response at Week 16|Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411118|NCT01172938|Secondary|Percentage of Participants With a ACR 50 Response at Week 16|Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411119|NCT01172938|Secondary|Percentage of Participants With Good or Moderate EULAR Response at Week 24|EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411120|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set; participants with a baseline dactylitis severity score > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411121|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 24|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411122|NCT01172938|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411123|NCT01172938|Secondary|Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16|Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set; participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411381|NCT01170754|Secondary|Bicarbonate Level in mmol/L|Bicarbonate level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
1411124|NCT01172938|Secondary|Percentage of Participants With MASES Improvement ≥ 20% at Week 16|Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411125|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1411126|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 24|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1411127|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1411128|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 24|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 24|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1411129|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 24|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1411130|NCT01172938|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 24|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||mm||Standard Error|Least Squares Mean
1411146|NCT01172873|Secondary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC): This is a 39-item self-report that measures anxiety symptoms. It provides a total score, as well as 10 subscales, although only total scores will be analyzed. MASC scores range from 0-117, with higher scores representing greater severity of anxiety symptoms. The MASC and will be administered at baseline, session 5, session 10 and the follow-up visit for adolescents.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.|||units on a scale||Standard Deviation|Mean
1411131|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: •78 tender joint count, •76 swollen joint count, •Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; •Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411132|NCT01172938|Secondary|Change From Baseline in SF-36 Physical Function at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1411133|NCT01172938|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16|"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from Baseline score indicates an improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1411134|NCT01172938|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 16|The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1411135|NCT01172938|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16|The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1411136|NCT01172938|Secondary|Change From Baseline in Dactylitis Severity Score at Week 16|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.|Baseline and Week 16|Full analysis set. Participants with a baseline dactylitis severity score > 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1411137|NCT01172938|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.|Baseline and Week 16|Full analysis set; participants with a baseline MASES > 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1411138|NCT01172938|Secondary|Change From Baseline in Patient’s Assessment of Pain at Week 16|"The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents no pain, and the right-hand boundary (score = 100 mm) represents pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded in millimeters."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||mm||Standard Error|Least Squares Mean
1411530|NCT01169103|Primary|Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months|As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy.|Baseline and 6 months||||mg/L||Standard Deviation|Mean
1411139|NCT01172938|Secondary|Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16|Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from Baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from Baseline by ≥ 20 mm VAS.|Baseline and Week 16|Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411140|NCT01172938|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
1411141|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 24|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.|||units on a scale||Standard Error|Least Squares Mean
1411142|NCT01172938|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|Percentage of participants with an American College of Rheumatology 20% (ACR20) response at Week 24. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 24|Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.|||percentage of participants|||Number
1411143|NCT01172938|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1411144|NCT01172938|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.|Baseline and Week 16|Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|||percentage of participants|||Number
1411145|NCT01172873|Secondary|Beck Depression Inventory (BDI)|Beck’s Depression Inventory (BDI): This is a 21-item self report that measures depression symptoms and will be used for both adults and adolescents at baseline, session 5, session 10 and the follow-up visit. BDI-II scores range from 0-63, with higher scores representing greater severity of depression symptoms.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures. Another was excluded because she was unable to provide reliable data on outcome measures.|||units on a scale||Standard Deviation|Mean
1413687|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 7%||at 4th month|The analysis population was prior to rescue treatment (FAS)|||Participants|||Number
1411147|NCT01172873|Primary|Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) for Adolescents|The CYBOCS is a semi-structured measure of Obsessive Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20.The CYBOCS differs from the adult Yale-Brown Obsessive Compulsive Scale (YBOCS) only in its use of simpler language. CYBOCS scores range from 0-40, with higher scores representing greater severity of symptoms. The CYBOCS will be administered by independent evaluators (IEs) at baseline, session 5, session 10 and the follow-up visit. It will be the primary outcome measure. The CYBOCS checklist will be used to determine symptom dimensions.|baseline, visit 5, visit 10, follow-up visit|Data from 14 adolescents were analyzed. One participant was excluded from analyses because he did not receive DCS at every treatment visit. Another was excluded because she was unable to provide reliable data on outcome measures.|||units on a scale||Standard Deviation|Mean
1411148|NCT01172847|Secondary|Number of Participants With Clinically Significant or Treatment Related Changes in Electrocardiogram (ECG)|ECG was recorded when participants were rested in a supine position for at least 5 minutes.|Screening; pre-dose on Day 1 and Day 5 of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
1411149|NCT01172847|Secondary|Number of Participants With Marked Abnormality in Laboratory Parameters|"Laboratory analysis included hematology (hemoglobin, hematocrit, erythrocytes, platelets counts, leukocytes counts, neutrophils, eosinophils, lymphocytes, basophils, and monocytes);, biochemistry (aspartate aminotransferase , alanine aminotransferase, gamma glutamyl trans peptidase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, albumin, creatinine, urea, creatine phosphokinase, total protein, sodium, chloride, calcium, phosphate, potassium, glucose (fasting), amylase, lipase, total cholesterol, and calculated creatinine clearance); and urinalysis.~Marked laboratory test values (high and low) falling outside the marked reference range and which also represents a clinically relevant change from baseline of at least a designated amount were recoded. In this study, marked abnormality ranges for phosphate as 0.75 – 1.60 millimole (mmol)/L and proteinuria (0 to 4+, and 1)."|Screening; Day -1 and Day 5 (pre-dose) of each treatment period; Follow-up visit|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
1411150|NCT01172847|Secondary|Number of Participants With Abnormal Vital Signs|Vital signs included heart rate (HR), blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), and body temperature. Blood pressure and pulse rate were recorded when participants were rested in a supine position for at least 5 minutes and after standing for 2 minutes. Vital signs values that fall outside the investigator’s normal ranges were recorded.|Screening (Days -28 to -2); pre-dose and 2h post-dose on D1 and D5 of each treatment period; at Follow-up visit (10 -14 days after last dose) for blood pressure and HR; Screening; Day -1 of each treatment period; Follow-up visit for temperature|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
1411151|NCT01172847|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 11 weeks|Safety Population included all participants who received at least one dose of the study medication, whether prematurely withdrawn from the study or not.|||participants|||Number
1411152|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Rimantadine|Cmax of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.|||ng/mL||90% Confidence Interval|Least Squares Mean
1411153|NCT01172847|Secondary|Maximum Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. Cmax of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine and was directly observed from the data.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|PK analysis population included all participants who were adhered to the protocol.|||ng/mL||90% Confidence Interval|Least Squares Mean
1411154|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Rimantadine|AUC0-12 of rimantadine was calculated following the administration of rimantadine alone or in combination with oseltamivir, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetic analysis population included all participants who were adhered to the protocol.|||h*ng/mL||90% Confidence Interval|Least Squares Mean
1411155|NCT01172847|Primary|Steady State Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours After Dosing (AUC0-12) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 of oseltamivir and oseltamivir carboxylate were calculated following the administration of oseltamivir alone or in combination with rimantadine, using the linear trapezoidal rule.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose on Day 5|Pharmacokinetics (PK) analysis population included all participants who were adhered to the protocol.|||hours (h)*nanogram (ng)/milliliter (mL)||90% Confidence Interval|Least Squares Mean
1411156|NCT01172821|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|||weeks||95% Confidence Interval|Median
1411382|NCT01170754|Secondary|Chloride Level in mmol/L|Chloride level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
1411157|NCT01172821|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|||weeks||95% Confidence Interval|Median
1411158|NCT01172821|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.|24 weeks|FAS of combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).|||Percentage of participants|||Number
1411159|NCT01172821|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS|||Days||Standard Error|Mean
1411160|NCT01172821|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Number of Puffs||Standard Error|Mean
1411161|NCT01172821|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
1411162|NCT01172821|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
1411163|NCT01172821|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS|||Percentage of Mean PEF||Standard Error|Mean
1411164|NCT01172821|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
1411165|NCT01172821|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
1411166|NCT01172821|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points.The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS|||Percentage of participants|||Number
1411167|NCT01172821|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items and ranges from from 0 (no symptoms) till 6 (highest intensity). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||units on a scale||Standard Error|Mean
1411168|NCT01172821|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|"Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment.~The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items and ranges from from 1 (highest intensity) till 7 (no symptoms). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week."|24 weeks|FAS|||units on a scale||Standard Error|Mean
1411169|NCT01172821|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre/min||Standard Error|Mean
1411170|NCT01172821|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
1411204|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3rd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 3rd block.|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 3rd block.|||absolute percentage||Standard Deviation|Mean
1411171|NCT01172821|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24- week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
1411172|NCT01172821|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
1411173|NCT01172821|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
1411174|NCT01172821|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
1411175|NCT01172821|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement.|||Litre||Standard Error|Mean
1411176|NCT01172808|Secondary|Time to First Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first asthma exacerbation (including severe, non-severe; symptomatic, asymptomatic; i.e. any exacerbation) during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)|||weeks||95% Confidence Interval|Median
1411177|NCT01172808|Secondary|Time to First Severe Asthma Exacerbation From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|Time to first severe asthma exacerbation during the 24-week treatment period on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821).|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)|||weeks||95% Confidence Interval|Median
1411178|NCT01172808|Primary|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.419 (NCT01172821) and the Present 205.418 (NCT01172808)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment)."|24 weeks|FAS of combined data from the two twin trials 205.419 (NCT01172821) and 205.418 (NCT01172808)|||Percentage of participants|||Number
1411179|NCT01172808|Secondary|Asthma Symptom-free Days Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. An asthma symptom-free day was defined as a day with no reported symptoms and no use of rescue medication.|Baseline and last 7 days before week 24 visit|FAS|||Days||Standard Error|Mean
1411180|NCT01172808|Secondary|Mean Number of Puffs of Rescue Medication During the Entire 24-h Day Based on the Weekly Mean Response at Week 24|Daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Number of Puffs||Standard Error|Mean
1411181|NCT01172808|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
1411182|NCT01172808|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre||Standard Error|Mean
1411183|NCT01172808|Secondary|PEF Variability|PEF daily variability was assesed by patients at home using the AM3 device. PEF variability is the absolute difference between morning and evening PEF value divided by their mean, based on the weekly mean response at week 24. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|Last 7 days before week 24 visit|FAS|||Percentage of mean PEF||Standard Error|Mean
1411184|NCT01172808|Secondary|Mean Pre-dose Evening PEF (PEF p.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
1411185|NCT01172808|Secondary|Mean Pre-dose Morning PEF (PEF a.m.) Based on the Weekly Mean Response at Week 24|Weekly means obtained during the last 7 days before week 24 measured by patients at home using the AM3 device. Response was defined as change from baseline. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|Baseline and last 7 days before week 24 visit|FAS|||Litre/min||Standard Error|Mean
1411186|NCT01172808|Secondary|The Responder Rate as Assessed by the ACQ|The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period. A patient was considered to be a responder if he or she was reported with an improvement (decrease) in ACQ total score of at least 0.5 points. The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).|24 weeks|FAS|||Percentage of Participants|||Number
1411187|NCT01172808|Secondary|Total Asthma Control Questionnaire (ACQ) Score at the End of the 24-week Treatment Period|Control of asthma as assessed by the ACQ determined at the end of 24-week treatment. The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||units on a scale||Standard Error|Mean
1411188|NCT01172808|Secondary|Total Asthma Quality of Life Questionnaire (AQLQs)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ(s)) determined at the end of 24-week treatment. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||units on a scale||Standard Error|Mean
1411189|NCT01172808|Secondary|Trough PEF Response|Trough peak expiratory flow (PEF) response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre/min||Standard Error|Mean
1411190|NCT01172808|Secondary|FVC Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
1411191|NCT01172808|Secondary|FEV1 Area Under Curve 0-3 Hours (AUC0-3h) Response|Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2) determined at the end of the 24-week treatment. Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|24 weeks|FAS|||Litre||Standard Error|Mean
1411192|NCT01172808|Secondary|Trough FVC Response|Trough FVC response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, country, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
1411193|NCT01172808|Secondary|Peak FVC Within 3 Hours Post-dose Response|Peak forced vital capacity (FVC) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
1411194|NCT01172808|Primary|Trough FEV1 Response|Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|FAS|||Litre||Standard Error|Mean
1411195|NCT01172808|Primary|Peak FEV1 Within 3 Hours Post-dose Response|Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.|24 weeks|Full Analysis Set (FAS) - all treated patients who had baseline data and at least 1 on-treatment efficacy measurement excluding patients from one centre due to non-compliance with good clinical practice.|||Litre||Standard Error|Mean
1411196|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|No blood sample was planned to be collected.||||||
1411197|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did come for the 3rd block. Among the patients who came for the 3rd block, blood sample was not collected in 5 Entonox patients and 1 Oxygen patient.|||pg/ml||Inter-Quartile Range|Median
1411198|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|before 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not come for 2nd block. Among patients came for the 2nd block, blood sample was not collected in 9 Entonox patients and 6 Oxygen patients.|||pg/ml||Inter-Quartile Range|Median
1411199|NCT01172600|Secondary|Biomarkers|BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α|baseline - before 1st block|Blood sample was not collected for 5 Entonox patients and 1 Oxygen patients.|||pg/ml||Inter-Quartile Range|Median
1411200|NCT01172600|Secondary|Usage of Opioid||3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow up.|||participants|||Number
1411201|NCT01172600|Secondary|Usage of Opioid||3rd block, typically at 2 months from baseline|21 Entonox patients and 26 Oxygen patients did not receive 2nd block.|||participants|||Number
1411202|NCT01172600|Secondary|Usage of Opioids||2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.|||participants|||Number
1411203|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to 3 months follow-up.|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|5 patients in each group were lost follow-up.|||absolute percentage||Standard Deviation|Mean
1411205|NCT01172600|Secondary|Change in Oswestry Score (% of Disability) From Baseline to 2nd Block|Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 2nd block.|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 Entonox patients and 11 Oxygen patients did not receive 2nd block.|||absolute percentage||Standard Deviation|Mean
1411206|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 3rd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 3rd block"|At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline|21 patients in the Entonox group and 26 patients in the Oxygen group did not receive the 2nd block treatment|||units on a scale||Standard Deviation|Mean
1411207|NCT01172600|Primary|Change in VAS Pain Score From Baseline to Before 2nd Block|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 2nd block."|At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline|10 patients in the Entonox group and 11 patients in the Oxygen group did not receive the 2nd block treatment|||units on a scale||Standard Deviation|Mean
1411208|NCT01172600|Primary|Change in VAS Pain Score From Baseline to 3 Month Follow-up|"10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up.~The primary outcome was the change in VAS pain score from baseline (before 1st block) to the 3 month follow-up."|At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)|For 10 patients with missing VAS at 3 month follow up: 5 patients who had 2nd or 3rd epidural block, we assigned the last VAS observation (i.e., from VAS before 2nd or 3rd block to 3 month follow-up); and for 5 patients who only had 1st epidural, we assigned the worst VAS (10) for Entonox patients and the best VAS (0) for Oxygen patients.|||units on a scale||Standard Deviation|Mean
1411209|NCT01172535|Primary|Proportion of Participants Tolerating LPV/r|Participants were considered to have tolerated medication if they did not stop treatment before the 24 week PK visit for any reason other than completing treatment or death not related to treatment.|Measured at study completion (week 24)|All participants|||proportion of participants||95% Confidence Interval|Number
1411210|NCT01172535|Primary|Number of Participants Experiencing Adverse Events of Grade 3 or 4|Adverse events were graded by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December, 2004, Clarification August 2009, which is available on the RSC web site (http://rsc.tech-res.com/safetyandpharmacovigilance/). Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death|Measured at study visits through end of study (weeks 2, 4, 12, 24)|All participants|||participants|||Number
1411211|NCT01172535|Secondary|Treatment Efficacy (CD4%)|Having CD4%≥25 at the week 24 visit.|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit|||proportion of participants||95% Confidence Interval|Number
1411212|NCT01172535|Secondary|Treatment Efficacy (HIV Viral Load)|Having HIV viral load <400 copies/mL at the week 24 visit|Measured at entry and study completion (week 24)|Participants with data from both study entry and the week 24 study visit|||proportion of participants||95% Confidence Interval|Number
1411213|NCT01172535|Secondary|Adherence|Adherence, defined as proportion of doses taken (note: proportion could be greater than 1.0 for reasons such as tablets having to be taken twice due to first one being spit out or imprecise measurement of liquid doses)|Measured at week 4, week 12, and study completion (week 24)|Participants bringing medication to be measured at the study visit|||Proportion of expected doses taken||Inter-Quartile Range|Median
1411214|NCT01172535|Primary|Proportion of Participants With an AUC of Less Than 10% of Adults|Proportion of participants with an AUC less that 10% of adults (AUC0-24 <104 mcg*hr/mL)|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants with complete pharmacokinetics data at week 4|||proportion of participants||90% Confidence Interval|Number
1411215|NCT01172535|Primary|Clearance of Lopinavir/Ritonavir (CL/F)|Clearance of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||L/h/kg||90% Confidence Interval|Geometric Mean
1411216|NCT01172535|Primary|Minimum Concentration of Lopinavir/Ritonavir (Cmin)|Minimum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||mcg/mL||90% Confidence Interval|Geometric Mean
1411217|NCT01172535|Primary|Maximum Concentration of Lopinavir/Ritonavir (Cmax)|Maximum concentration of lopinavir/ritonavir, as determined by analysis of 12-hour pharmacokinetic sampling|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||mcg/mL||90% Confidence Interval|Geometric Mean
1411218|NCT01172535|Primary|Lopinovir/Ritonavir Area Under the Concentration-time Curve (AUC0-24)|Area under the curve over 24 hours (AUC0-24), as determined by a non-compartmental analysis of 12-hour pharmacokinetic sampling for lopinavir/ritonavir|Measured at 4 weeks of treatment prior to the observed dose and at 2, 4, 6, 8, and 12 hours post-dose|Participants having complete pharmacokinetics data at week 4|||mcg*hr/mL||90% Confidence Interval|Geometric Mean
1411237|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|after 8 weeks of treatment||||raw score||Standard Deviation|Mean
1411383|NCT01170754|Secondary|Potassium Level in mmol/L|Potassium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
1411219|NCT01172522|Primary|Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention|Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants.|Baseline, weekly, and end of study +7 days|Thirty participants in total; 15 had fexofenadine left and placebo right; 15 had fexofenadine right and placebo left.|||participants|||Number
1411220|NCT01172418|Secondary|Patient Survival||at 3 years post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
1411221|NCT01172418|Secondary|Patient Survival||at 1 year post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
1411222|NCT01172418|Secondary|Graft Survival||at 3 years post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
1411223|NCT01172418|Secondary|Graft Survival||at 1 year post-transplant||||actuarial percentage of participants||95% Confidence Interval|Number
1411224|NCT01172418|Primary|Incidence of Acute Rejection at One Year Post-transplant||at one year post-transplant||||percentage of patients having BPAR|||Number
1411225|NCT01172353|Secondary|Dialysis During Hospitalization||During hospitalization||||participants|||Number
1411226|NCT01172353|Primary|Contrast-induced Nephropathy|rise in serum creatinine >0,5mg/dl|48 hours||||percentage of contrast nephropaty|||Number
1411227|NCT01172288|Secondary|Number of Participants With Adverse Effects|Number of participants with adverse events according to the Pediatric Adverse Events Rating Scale|12 weeks||||participants|||Number
1411228|NCT01172288|Secondary|Overall Improvement|Clinical Global Impression - Improvement Scale (CGI-I). The CGI is a 7-point scare that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.|12 weeks||||units on a scale||Standard Deviation|Mean
1411229|NCT01172288|Secondary|Improvement in OCD Severity|Childrens' Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). 10-item scale. Each item is rated from 0-4. A sum total is calculated by adding items 1-10. 0-7: Subclinical. 8-15: Mild. 16-23: Moderate. 24-31: Severe. 32-40: Extreme.|12 weeks||||units on a scale||Standard Deviation|Mean
1411230|NCT01172288|Secondary|Improvement of Premonitory Urges|"Premonitory Urge for Tics Scale (PUTS). Items are rated on a scale of 1-4 from least to most. A total score is calculated by summing the scores of all items. Nine is the minimum possible score. A score of 12.5-24.5 indicates medium intensity of premonitory urges for tics. A score of 25-30.5 indicates high intensity which may be associated with marked impairment. Scores 31 and above indicate extremely high intensity with probable severe impairment. A score of 36 is the maximum score possible."|12 weeks||||units on a scale||Standard Deviation|Mean
1411231|NCT01172288|Primary|Improvement in Tic Severity|"Yale Global Tic Severity Scale is a standard psychiatric measure that rates tics from 0 (no tics) to 100 (most severe tics).~It separately rates motor tics and vocal tics in 5 subscales (number, frequency, intensity, complexity and interference) where the maximum severity score for motor tics is 25 and for vocal tics is 25. Giving us the Total Tic Severity Score maximum of 50.~The additional Impairment Scale rates the degree of disability caused by the tics ranging from 0 (none) to 50 (severe). When these two scores are added we get the Yale Global Tic Severity Scale Score."|12 weeks||||units on a scale||Standard Deviation|Mean
1411232|NCT01172197|Primary|Pain|Number achieving pain on movement of knee measured as 0 on a verbal pain rating scale at 30h after start of perineural infusion|30 hours|Knee replacement. All obtained pain relief defined as pain score = 0 on a verbal pain rating scale|||Participants|||Count of Participants
1411233|NCT01172184|Secondary|Number of Participants With Heart Failure Requiring Rehospitalization During Follow-up Period|After discharge from index hospitalization of surgical intervention, heart failure with rehospitalization will be assessed. Heart failure with re-hospitalization was documented by at least one of the following: worse exercise tolerance and respiratory distress with NYHA class III or IV symptoms, presence of pulmonary rales, or chest radiography showing pulmonary congestion, which needed an augmented decongestive regimen during an in-hospital stay. The correlation between left atrial distensibility and heart failure was analyzed. ROC curve was used to estimate the best cut-off point.|1-2 years||||participants|||Number
1411234|NCT01172184|Secondary|Number of Participants With Post-operation Atrial Fibrillation|After operation, patients received continuous EKG monitor during the ICU stay. After transfer to ordinary ward, patients received 2 times of EKG record per day and another EKG would be done if patients felt palpitation and irregular heart beats were found by nursing staffs. The event of atrial fibrillation (Af) was defined as irregular irregular heart beats which was lack of p wave and last for more than 30 seconds. The relationship between left atrial distensibility and post-operative Af was analysed. ROC curve was used to assess the best cutoff value of left atrial distensibility.|baseline and 1 year||||participants|||Number
1411235|NCT01172184|Primary|Left Ventricular Filling Pressure More Than 15 mmHg Measured by Left Ventricular Catheterization|Since left ventricular filling pressure more than 15 mmHg indicated poor ventricular compliance and more cardiovascular event in many prior reports, the current study used it as the threshold. Otherwise, the correlation between left ventricular filling pressure and left atrial distensibility was assessed. ROC curve was used to estimate the best cut-off point of left atrial distensibility for predicting left ventricular filling pressure more than 15 mmHg.|1 year|Severe mitral regurgitation affects the accuracy of left ventricular filling pressure estimated by tissue Doppler imaging. Therefore, we conducted this study using left atrial parameters to assess left ventricular filling pressure in patients with severe mitral regurgitation.|||mmHg||Standard Deviation|Mean
1411236|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|after 8 weeks of treatment||||raw score||Standard Deviation|Mean
1411238|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|after 8 weeks of treatment||||raw score||Standard Deviation|Mean
1411239|NCT01172145|Secondary|Zarit Burden Inventory|Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.|at baseline||||raw score||Standard Deviation|Mean
1411240|NCT01172145|Secondary|The Direct Assessment of Functional Status Scale|A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.|at baseline||||raw score||Standard Deviation|Mean
1411241|NCT01172145|Secondary|Lawton Brody Activities of Daily Living Questionnaire|Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.|at baseline||||raw score||Standard Deviation|Mean
1411242|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|after 8 weeks of treatment||||T-score||Standard Deviation|Mean
1411243|NCT01172145|Primary|Apathy|The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.|at baseline||||T-score||Standard Deviation|Mean
1411244|NCT01171989|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|After the booster dose of the study vaccine up to the study end (from Month 0 to Month 1)|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.|||Participants|||Count of Participants
1411245|NCT01171989|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented.|||Participants|||Count of Participants
1411246|NCT01171989|Secondary|Number of Subjects With Any Solicited General Symptoms|Solicited general symptoms assessed included drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5º C). Any= all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.|During the 8-day (Days 0-7) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.|||Participants|||Count of Participants
1411247|NCT01171989|Secondary|Number of Subjects With Any Solicited Local Symptoms|Solicited local symptoms assessed included pain, redness and swelling. Any= all reports of the speecified symptom irrespective of intensity grade.|During the 8-day (Days 0-7) post-booster period|The analysis was performed on the Booster Total Vaccinated Cohort, which included all subjects with the booster vaccine administration documented and who had the symptoms sheet filled in.|||Participants|||Count of Participants
1411248|NCT01171989|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value ≥ 5 EL.U/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1411249|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411250|NCT01171989|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titres|Titers were expressed as geometric mean titters (GMTs) for the seropositivity cut-off value of ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1411384|NCT01170754|Secondary|Sodium Level in mmol/L|Sodium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mmol/L||Standard Deviation|Mean
1411251|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-poliovirus Types 1, 2 and 3|A seropositive subject was defined as a subject with anti-polio type 1, 2 or 3 ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411252|NCT01171989|Secondary|Anti-HBs Antibody Concentrations|Concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|At Month 0 and Month 1, before and after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1411253|NCT01171989|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Cut-off Values|The cut-off values assessed were 3.3 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411254|NCT01171989|Secondary|Anti-D and Anti-T Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.1 IU/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1411255|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T)|A seropositive subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411256|NCT01171989|Secondary|Anti-PSC Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1411257|NCT01171989|Secondary|Number of Subjects With Polysaccharide N. Meningitidis Serogroup C (PSC) Antibody Concentrations ≥ Cut-off Values|The cut-off values assessed were ≥ 0.3 μg/mL and ≥ 2 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411258|NCT01171989|Secondary|Anti-rSBA-MenC Antibody Titres|Antibody titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1411259|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-rSBA-MenC|A seropositive subject for anti-rSBA-MenC was defined as a subject with antibody titers greater than or equal to (≥) 1:128.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411260|NCT01171989|Secondary|Number of Seroprotected Subjects Against rSBA-MenC|A seroprotected subject was defined as a subject with anti-rSBA-MenC antibody titers ≥ 1:8.|At Month 0, before the booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411261|NCT01171989|Secondary|Anti-PRP Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the cut-off value of ≥ 0.15 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1411262|NCT01171989|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off|The cut-off value of the assay was an anti-PRP antibody concentration ≥ 1 μg/mL.|At Month 0 and Month 1, before and one month after booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1413688|NCT01152385|Secondary|Change in Fasting Plasma Glucose (FPG)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||mg/dL||Standard Deviation|Mean
1411263|NCT01171989|Secondary|Number of Seropositive Subjects for Anti-PRP|A seropositive subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL.|At Month 0, before the booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411264|NCT01171989|Primary|Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Completent (rSBA-MenC)|A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.|At Month 1, post-booster dose|The analysis was performed on the Booster ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411265|NCT01171989|Primary|Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).|At Month 1, post-booster dose|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1411266|NCT01171976|Secondary|EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24|The Euro Quality of Life Questionnaire (EQ-5D) is an indirect utility questionnaire. It is a standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1= “no problems”, 2=“some problems” and 3=“extreme problems” . A composite health index was then defined by combining the levels for each dimension. Overall, 243 health states are possible. For each health state, the EuroQol group has assigned a utility value typically between 0 and 1 with lower scores representing a higher level of dysfunction|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1411267|NCT01171976|Secondary|Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and symptoms on general health. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. Each response was recoded per the scoring rules outlined in the National Eye Institute (NEI) VFQ-25 Scoring Algorithm. Under this scoring algorithm , the recoded values range between 0 and 100 and a high score means a better functioning|Baseline, Month 12 and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1411268|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline and 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percent Change||Standard Deviation|Mean
1411269|NCT01171976|Secondary|Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percent Change||Standard Deviation|Mean
1411270|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline, 24 month|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percentage of pateints|||Number
1411345|NCT01171677|Primary|Stroop Color/Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color-Word test is the third subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility and resistance to interference.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411271|NCT01171976|Secondary|Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline, Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Percentage of patients|||Number
1411272|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline and Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
1411273|NCT01171976|Secondary|Visual Acuity of the Study Eye: Change From Baseline at Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline and Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
1411274|NCT01171976|Secondary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline to Month 24|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
1411275|NCT01171976|Primary|Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12|Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS–like VA testing charts at a starting distance of 4 meters.|Baseline to Month 12|Analyzed set included all randomized patients who received at least one application of study treatment and had at least one post baseline efficacy assessment. If missing values occurred without a subsequent observed value, the last observed value was carried forward to subsequent scheduled visits by means of a last observation carried forward.|||Letters||Standard Deviation|Mean
1411276|NCT01171963|Secondary|Concentrations of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 5 EL.U/mL) for all antibodies assessed (anti-PT, anti-FHA and anti-PRN). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1411277|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.|Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). A subject seropositive for anti-PT/anti-FHA/anti-PRN antibodies was defined as a subject with an anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
1411278|NCT01171963|Secondary|Titers for Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibodies|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seroprotection cut-off (≥ 8 estimated doses 50% [ED50] for anti-poliovirus type 1 [anti-polio 1]/anti-polio 2/anti-polio 3 antibodies. This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||titers||95% Confidence Interval|Geometric Mean
1411288|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.|||Participants|||Count of Participants
1411279|NCT01171963|Secondary|Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3.|A subject seroprotected against poliovirus types 1, 2 and 3 was defined as a subject with anti-poliovirus type 1 (anti-polio 1)/anti-polio 2/anti-polio 3 antibody titer greater than or equal to (≥) 8 estimated doses 50% (ED50). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo (cf. population definition below).|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
1411280|NCT01171963|Secondary|Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off assay (≥ 0.1 IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||IU/mL||95% Confidence Interval|Geometric Mean
1411281|NCT01171963|Secondary|Number of Subjects Seroprotected Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a subject with an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo|At Day 0 and at Month 4|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
1411282|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.|||U/mL||95% Confidence Interval|Geometric Mean
1411283|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age.|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||U/mL||95% Confidence Interval|Geometric Mean
1411284|NCT01171963|Secondary|Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||U/mL||95% Confidence Interval|Geometric Mean
1411285|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.|||Participants|||Count of Participants
1411286|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
1411287|NCT01171963|Secondary|Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).|At Day 0, Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
1411376|NCT01170754|Secondary|Magnesium Level in mg/dl|Magnesium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
1439882|NCT00936663|Primary|Fasting Blood Glucose|Fasting blood glucose levels at 1 year|1 year||||mg/dl||Standard Deviation|Mean
1411289|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
1411290|NCT01171963|Secondary|Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies|A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (<) 20 U/mL.|At Month 2 and at 12 months of age|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.|||Participants|||Count of Participants
1411291|NCT01171963|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or result in disability/incapacity. Any = occurrence of an SAE regardless of the intensity grade or relationship to vaccination.|Throughout the entire study period (from Day 0 to Study End at Month 21)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.|||Participants|||Count of Participants
1411292|NCT01171963|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination.|Within the 31-day (Days 0–30) follow-up periods following any dose of the Rotarix vaccine or placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.|||Participants|||Count of Participants
1411293|NCT01171963|Secondary|Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix Vaccine/Placebo|Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods following Dose 2 of the Rotarix vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.|||Participants|||Count of Participants
1411294|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines|Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix vaccine|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.|||Participants|||Count of Participants
1411295|NCT01171963|Secondary|Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo|Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to [>=] 37.5 degrees Celsius [°C] (if GSK scale) or >= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix vaccine/placebo.|Within the 8-day (Days 0–7) follow-up periods after any dose of Rotarix vaccine/placebo|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.|||Participants|||Count of Participants
1411296|NCT01171963|Secondary|Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause|Severe GE was defined as an episode of GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
1411377|NCT01170754|Secondary|Calcium Level in mg/dl|Calcium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
1413689|NCT01152385|Primary|Change in Haemoglobin A1c (HbA1c)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
1411297|NCT01171963|Secondary|Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
1411298|NCT01171963|Secondary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
1411299|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.|A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
1411300|NCT01171963|Secondary|Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
1411301|NCT01171963|Primary|Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains|A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (>=) 11 on a 20-point Vesikari scoring system.|From Month 1 ½ to Month 21|The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.|||Participants|||Count of Participants
1411302|NCT01171924|Primary|Number of Participants With Adverse Events|Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.|12-15 months||||participants|||Number
1411303|NCT01171898|Secondary|Phase 1 and 2: Objective Response Rate|Objective Response Rate was defined as the percentage of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST). Where, CR defined as disappearance of all target lesions. Any pathological lymph nodes must had reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions. Confirmed responses were those that persisted on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to approximately 7 years|mITT population included all participants who received at least one dose of apalutamide and who were eligible for the cohort that they were enrolled in.|||Percentage of Participants||95% Confidence Interval|Number
1411304|NCT01171898|Secondary|Phase 1 and 2: Progression-free Survival (PFS)|PFS was defined as the time from randomization to the radiographic disease progression or death, whichever occurred first. Radiographic progression defined by at least one of the following: a) Soft tissue progression by modified RECIST confirmed on repeat imaging >= 6 weeks later; b) Progression by bone scans: 1) first bone scan with >= 2 new lesions compared to baseline observed <12 weeks from start date and confirmed on a second bone scan >=6 weeks later that showed >=2 additional lesions (a total of >=4 new lesions compared to baseline); or 2) first bone scan with >=2 new lesions compared to baseline observed >=12 weeks from start date and the new lesions verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline).|Up to approximately 7 years|mITT population included all participants who received at least 1 dose of apalutamide and who were eligible for cohort that they were enrolled in. PFS results are reported for Dose Escalation Cohort (Phase 1) and cohort 2, 3 (Phase 2) as no PFS analysis was performed for Cohort 1 of Phase 2 per planned analysis.|||Months||95% Confidence Interval|Median
1411305|NCT01171898|Secondary|Phase 2: Median Metastasis-Free Survival (MFS)|MFS was defined as the time from the start of treatment until new metastatic lesions were observed on Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) scans or radionuclide bone scans (according to PCWG2 criteria: appearance of >=2 new lesions, and, for the first reassessment only, a confirmatory scan performed 6 or more weeks later that showed at least 2 or more additional new lesions) or death, whichever occurred first.|Up to approximately 7 years|mITT population included all participants who received at least 1 dose of apalutamide and were eligible for cohort that they were enrolled in. MFS results are reported for Cohort 1 (Phase 2) participants only as MFS analysis was not performed for other cohorts that is Dose Escalation Cohort (Phase 1) and Cohort 2, 3 (Phase 2) per planned analysis.|||Months||95% Confidence Interval|Median
1411306|NCT01171898|Secondary|Phase 1 and 2: Median Time to PSA Progression|Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined by the PCWG2 criteria. PCWG2 criteria: For participants who achieved >=50% decrease from the baseline PSA, assessment of time to disease progression was when the PSA increased 25% and at a minimum of 2 ng/mL above the nadir at 3 or more weeks later. For participants without a PSA decrease, the time for progression was calculated at the time when the PSA progression was >=25% and >=2 ng/mL after 12 weeks.|Up to approximately 7 years|mITT population included all participants who received at least one dose of apalutamide and who were eligible for the cohort that they were enrolled in.|||Months||95% Confidence Interval|Median
1411307|NCT01171898|Primary|Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12|Percentage of participants with >=50% decrease in PSA compared to baseline were assessed at Week 12. PSA progression was defined by the protocol-specific Prostate Cancer Working Group 2 (PCWG2) criteria: PSA increase greater than or equal to [>=] 25 percent [%] and >=2 nanogram per milliliter [ng/mL] above the nadir confirmed >=3 weeks later; or >=25% and >=2 ng/mL above baseline PSA after 12 weeks.|Week 12|Modified intent-to-treat (mITT) population included all participants who received at least one dose of apalutamide and who were eligible for the cohort that they were enrolled in.|||Percentage of Participants|||Number
1411308|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411309|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411310|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Any revascularization: TLR or TVR or non-TVR"|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411311|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411312|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411313|NCT01171820|Secondary|Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)|"Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac.~Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium.~Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411378|NCT01170754|Secondary|Glucose Level in mg/dl|Glucose level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
1411314|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411315|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411316|NCT01171820|Secondary|Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)|"Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death.~MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.~Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR >=70% in the absence of the above signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411317|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|393 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411318|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411319|NCT01171820|Secondary|Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent.~TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself.~A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs."|37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411320|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|365 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411321|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|254 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411322|NCT01171820|Secondary|Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)|"The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.)~Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death >30 days after stent placement."|0 to 37 days|Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.|||Percentage of participants||95% Confidence Interval|Number
1411323|NCT01171820|Secondary|In-segment Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.~This value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percent diameter stenosis|Participants|Standard Deviation|Mean
1411324|NCT01171820|Secondary|In-stent Percent Diameter Stenosis (% DS)|"This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed.~This value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA."|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percent diameter stenosis|Participants|Standard Deviation|Mean
1411325|NCT01171820|Secondary|In-segment Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percentage of participants|Participants|95% Confidence Interval|Number
1411326|NCT01171820|Secondary|In-stent Angiographic Binary Restenosis Rate|Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||Percentage of participants|Participants|95% Confidence Interval|Number
1411327|NCT01171820|Secondary|Distal Late Loss|Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||millimeters|Participants|Standard Deviation|Mean
1411328|NCT01171820|Secondary|Proximal Late Loss|Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up|270 day|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||millimeters|Participants|Standard Deviation|Mean
1411329|NCT01171820|Secondary|In-segment Late Loss|In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.|||millimeters|Participants|Standard Deviation|Mean
1411344|NCT01171677|Primary|Trailmaking Test A|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline to end of intervention (week 14)|participants completing trial|||seconds||Standard Deviation|Mean
1411330|NCT01171820|Secondary|Clinical Procedure Success (Per-patient)|Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.|immediately post-procedure|The sample size for clinical procedure success is based on the number of evaluable patients, for whom data is available to define clinical procedure success.|||Percentage of participants||95% Confidence Interval|Number
1411331|NCT01171820|Secondary|Clinical Device Success (Per-lesion)|Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.|immediately post-procedure|Analysis based on intention to treat (ITT) population.|||Percentage of lesions|Participants|95% Confidence Interval|Number
1411332|NCT01171820|Primary|In-stent Late Loss (LL)|In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up|270 days|Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up.|||millimeters|Participants|Standard Deviation|Mean
1411333|NCT01171794|Primary|Acute Mountain Sickness Severity|Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms|2 days|Participants meeting all inclusion criteria were analyzed|||units on a scale||Standard Deviation|Mean
1411334|NCT01171794|Primary|Acute Mountain Sickness|Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness|2 days|Participants meeting all inclusion criteria were analyzed|||Participants|||Count of Participants
1411335|NCT01171690|Secondary|Safety Analysis|Arms were compared for total number of adverse events, including severe and serious adverse events.|Approximately 90 days after surgery||||events|||Number
1411336|NCT01171690|Primary|Hospital Length of Stay|"Hospital length of stay from initiation of therapy with calcium and calcitriol to ready to discharge from a calcium perspective (calcium level > 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for intravenous (IV) calcium in last 24 hours)."|Approximately 7 days after surgery||||days||Standard Deviation|Mean
1411337|NCT01171677|Primary|Roesenberg Self Esteem|The Rosenberg Self-Esteem Scale is a 10-item, 4-point Likert scale used to assess global self-esteem. The scale ranges from 0-30 with higher scores indicating higher the self-esteem.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411338|NCT01171677|Primary|Quality of Life (QoL)|The Quality of Life (QoL) assessment is adapted from Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The 23-item QoL consists of five subscales: physical health/activities, feelings, leisure time activities, social relations, and general activities. The scale ranges from 23-115; the higher score indicates higher quality of life enjoyment and satisfaction.|Baseline to end of intervention (week 14)|participants completing intervention|||units on a scale||Standard Deviation|Mean
1411339|NCT01171677|Primary|Self-Efficacy for Abstinence|The Self-Efficacy for Abstinence assessment is adapted from DiClemente (1994)’s Alcohol Abstinence Self-Efficacy. The modified 10-item, 5-point Likert scale (Not at all to Extremely) assesses confidence in abstaining from alcohol. The scale is comprised of four subscales: negative affect, social/positive, physical and other concerns, and withdrawal and urges. Overall abstinence self-efficacy score is calculated by summing each item. The scale ranges from 10-50, the higher the score the higher the self-efficacy for abstinence.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411340|NCT01171677|Primary|Wechsler Test of Adult Reading (WTAR)|Wechsler Test of Adult Reading (WTAR) measures reading ability. The test involves 50 incorrectly spelled words. The score is computed based on the number of correctly pronounced words. The scale ranges from 0-50, the higher the score the higher the reading ability.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411341|NCT01171677|Primary|Controlled Oral Word Association Test (COWAT)|Controlled Oral Word Association Test (COWAT) measures verbal fluency. The assessment consists of three trials; the total score is a sum of all three trials. The scale ranges from 0-90, the higher the score the higher the verbal fluency.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411342|NCT01171677|Primary|Digit Span|Digit span measures attention efficiency. The Digit-span task is used to measure verbal working memory. Two subscales, Digits Forward and Digits Backward, were combined for a total scale range from 0-30, the higher the score the better the working memory.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411343|NCT01171677|Primary|Trailmaking Test B|Trailmaking Test A and B measures cognitive shifting, visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. The test generally requires ability to sequence (Parts A and B), ability to shift cognitive set (Part B), and processing speed (Parts A and B). Part A and Part B are scored separately and expressed in terms of the number of seconds it takes the participant to complete each section, the higher the score the longer it took the subject to complete the test. Trailmaking Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline to end of intervention (week 14)|participants completing each arm|||seconds||Standard Deviation|Mean
1411379|NCT01170754|Secondary|Creatinine Level in mg/dl|Creatinine level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
1442152|NCT00919633|Primary|Viral Load: Incidence of Sustained Virologic Response (SVR)||24 weeks after treatment is complete||||participants|||Number
1411346|NCT01171677|Primary|Stroop Color|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Color test is the second subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411347|NCT01171677|Primary|Stroop Word|Stroop Color Word Test assesses cognitive flexibility, resistance to interference from outside stimuli, creativity, psychopathology and cognitive complexity. The Stroop consists of three subscales: Word, Color, and Color-Word. The Stroop Word test is the first subscale administered. The raw score is determined by the number of correct responses within a 90-second period. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411348|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recognition|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recognition is administered immediately after the HVLT Delayed Recall subscale and involves 12 forced choice responses. The HVLT Delayed Recognition scale ranges from 0-24, the higher score associated with greater recognition ability.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411349|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Delayed Recall is administered 20-25 minutes after the HVLT Total Recall. The HVLT Delayed Recall scale ranges from 0-12, the higher score associated with greater retention.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411350|NCT01171677|Primary|Hopkins Verbal Learning Test (HVLT) Total Recall|The Hopkins Verbal Learning Test (HVLT) assesses Verbal learning and memory, immediate recall, delayed recall, and delayed recognition. The HVLT is comprised of three subscales: HVLT Total Recall, HVLT Delayed Recall, and HVLT Delayed Recognition. HVLT Total Recall is the sum of 3 trials in which twelve words are read to and repeated back by subject. The HVLT Total Recall scale ranges from 0-36, the higher score associated with greater verbal learning.|Baseline to end of intervention (week 14)|participants completing each arm|||units on a scale||Standard Deviation|Mean
1411351|NCT01171612|Secondary|Number of Patients With Adverse Events Related With Antiplatelet Therapy Management|"Perioperative withdrawal antiplatelet therapy is defined with > or = 5 days without therapy~We create 3 categories:~Not withdrawal~Complete withdrawal (5 or > days without antiplatelet drugs , mono or dual therapy)~Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ > 5 days"|90 days after surgery|MACCEs|||participants|||Number
1411352|NCT01171612|Secondary|Major Haemorrhagic Events|Transfusion > = 2 red blood cells Units, haemoglobin descent >= 20 gr/dL, intracerebral haemorrhage|up to 90 days after surgery||||participants|||Number
1411353|NCT01171612|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCEs)|Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest|up to 90 days after surgery||||participants|||Number
1411354|NCT01171534|Secondary|Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure|Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.|One year|This study was terminated before this information was collected and analyzed.||||||
1411355|NCT01171534|Secondary|Quality of Life|Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year|This study was terminated before any of this information was collected and analyzed.||||||
1411356|NCT01171534|Secondary|Pain|Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months|One Year|too low of an enrollment volume to analyze||||||
1411357|NCT01171534|Primary|Performance of DermaClose System in Treatment of Fasciotomy Wounds|Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation|One year|Too low of an enrollment volume to analyze||||||
1411358|NCT01171521|Secondary|Pain|Visual Analog Pain Scale (VAS) with DermaClose use, and on study wound at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. The scale goes from 0 to 10 with 0 being no pain and 10 being the most severe pain imaginable. It is a visual analog scale so is continuous data.|6 months||||units on a scale||Standard Deviation|Mean
1411359|NCT01171521|Primary|Quality of Life|"The SF-12 contains 12 items from the SF-36 Health Survey - . The SF-12 contains one or two items that measure each of the eight concepts included in the SF-36.~The Quality of Life SF-12 is a scale from 0 - 100, in which 0 = poor functioning and 100 = excellent functioning."|6 months||||units on a scale||Standard Deviation|Mean
1411360|NCT01171183|Secondary|Retention|number of weeks each participant is on study protocol|12 weeks|Those eligible participants who entered the residential facility and received at least one dose of study medication. One person in the carvedilol group is excluded from all analyses due to not meeting inclusion criteria.|||Weeks||Standard Deviation|Mean
1411361|NCT01171183|Primary|Urine Toxicology Screens|Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.|based on thrice weekly urine results during the 10-week outpatient phase|Those who completed the residential facility and attended at least one outpatient clinic visit to complete assessments.|||percentage of cocaine negative urines||Standard Deviation|Mean
1411362|NCT01171118|Primary|AHI - Apnea Hypopnea Index|This is a standard metric used to describe severity of disordered breathing during sleep.Normal healthy subjects would have an AHI value of zero during sleep. Mild disordered breathing would correspond to a value of 5 to 10 events per hours; moderate 10-25; severe would be over 25|2- 2 1/2 hours during study visit|This is a standard size for this type of sleep study and was performed per protocol.|||events per hour||Standard Deviation|Mean
1411363|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From day 8 post last dose of treatment up-to Week 72|Safety population included all treated participants.|||participants|||Number
1411364|NCT01170962|Secondary|Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.|||participants|||Number
1411365|NCT01170962|Secondary|Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures|Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.|Baseline to follow-up Week 48|All treated participants who received at least 1 dose of study therapy.|||participants|||Number
1411366|NCT01170962|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)|SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1411367|NCT01170962|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1411368|NCT01170962|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1411369|NCT01170962|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From first dose to last dose plus 7 days, up to 49 weeks|Safety population included all treated participants.|||participants|||Number
1411370|NCT01170962|Primary|Percentage of Participants With 24-week Sustained Virologic Response (SVR24)|SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1411371|NCT01170962|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4, Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1411372|NCT01170949|Primary|Urticaria Activity Score (% Change From Baseline)|The weekly UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories “number of wheals” and “intensity of pruritus”. “Number of wheals” is scored as 0 = no wheals, 1 = some wheals (<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. “Intensity of pruritus” is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42.|Day 28|ITT = 73|||percentage of UAS baseline||Standard Deviation|Mean
1411373|NCT01170884|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 12|Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-Treat (ITT) included all subjects who were randomized to study medication.|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
1411374|NCT01170754|Other Pre-specified|Boston Prep Scale (Per Protocol Analysis)|"Analysis includes a sub-group of subjects who drank >75% of the preparation and adhered to a clear liquid diet (Per Protocol).~The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:"|photographs were taken throughout colonoscopy and reviewed within 1 month after procedure|Includes subjects who followed instructions (Per Protocol analysis)|||units on a scale||Standard Deviation|Mean
1411375|NCT01170754|Secondary|Phosphorus Level in mg/dl|Phosphorus level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.|Day of procedure||||mg/dl||Standard Deviation|Mean
1411666|NCT01168427|Secondary|Techniques and Procedures Utilized During Reveal In-office Implants|Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.|At implant|||||||
1411385|NCT01170754|Primary|Boston Prep Scale|"The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely.~The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:~0 = Unprepared colon segment with mucosa not seen due to solid stool.~= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen.~= Minor amount of residual staining, small fragments of stool and/or opaque liquid~= clear colon without staining"|photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.|Includes all subjects who were enrolled and underwent procedure (Intention-to-treat analysis)|||units on a scale||Standard Deviation|Mean
1411386|NCT01170663|Other Pre-specified|Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 103 weeks and within 30 days of last dose of study drug|All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received.|||participants|||Number
1411387|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score|The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale [1 (no problem), 2 (some problems), and 3 (major problems)]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.|||units on a scale||Standard Deviation|Mean
1411388|NCT01170663|Secondary|Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status|EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains [physical, role, cognitive, emotional, and social], 9 symptom scales [fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Baseline, end of therapy (up to 103 weeks)|All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.|||units on a scale||Standard Deviation|Mean
1411389|NCT01170663|Secondary|Cmin Prior to 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1 (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1411390|NCT01170663|Secondary|Cmin Prior to 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 (28-day cycle)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmin observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1411391|NCT01170663|Secondary|Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion|This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed.|Cycle 1, Day 1 predose (28-day cycles)|Zero participants were analyzed.||||||
1411392|NCT01170663|Secondary|Cmax After 7th Ramucirumab (IMC-1211B) Infusion||Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1411393|NCT01170663|Secondary|Cmax After 4th Ramucirumab (IMC-1211B) Infusion||Cycle 2, Day 15 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1411394|NCT01170663|Secondary|Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion||Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles)|All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1411395|NCT01170663|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)|Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.|Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks|All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies.|||percentage of participants|||Number
1411396|NCT01170663|Secondary|Percentage of Participants With CR or PR (Objective Response Rate [ORR])|ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)*100.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1411667|NCT01168427|Secondary|Surgical Staff Utilized for Reveal In-office Implants|Observational analysis of surgical staff present at the Reveal Implants|At implant|||||||
1411397|NCT01170663|Secondary|Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD|BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized.|||percentage of participants|||Number
1411398|NCT01170663|Secondary|Time to Progressive Disease (TTP)|TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.|Baseline up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94.|||months||95% Confidence Interval|Median
1411399|NCT01170663|Secondary|Progression-Free Survival (PFS)|PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.|Randomization up to 22.2 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39.|||months||95% Confidence Interval|Median
1411400|NCT01170663|Primary|Overall Survival Time (OS)|OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.|Randomization up to 27.5 months|All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.|||months||95% Confidence Interval|Median
1411401|NCT01170598|Primary|Program Adherence.|Adherence to supervised exercise program assessed as a percentage of exercise sessions completed(number of days of supervised exercise performed/the number of days that patients were approached to participate).|Baseline, Post-induction (weeks 4-6)||||percentage of exercise days completed|||Number
1411402|NCT01170598|Primary|Retention|Percentage of participants who remained in the study (did not withdraw voluntarily).|Baseline, Post-induction (weeks 4-6)||||percentage of participants|||Number
1411403|NCT01170598|Primary|Recruitment Rate|Ratio of patients who consented to participate out of all eligible patients expressed as a percentage (eligible patients who consented to participation/eligible patients who declined participation).|Baseline|For this outcome measure we analyzed 52 participants (rather than 35). Fifty-two participants met the study eligibility criteria. Thirty-five out of 52 consented to participate which is how we derived our recruitment rate of 67% (35/52).|||percentage of patients|||Number
1411404|NCT01170598|Secondary|Development of Sepsis|Development of sepsis (percentage of participants who developed sepsis during induction chemotherapy course).|Post-induction (weeks 4-6)||||percentage of participants|||Number
1411405|NCT01170598|Secondary|Intensive Care Unit (ICU) Admission|Intensive care unit (ICU) admission (percentage of participants admitted to ICU during induction chemotherapy course).|Post-induction (weeks 4-6)||||percentage of participants|||Number
1411406|NCT01170598|Secondary|Length of Stay|Length of stay (date of admission to hospital to date of discharge).|Post-induction (weeks 4-6)||||days||Standard Deviation|Mean
1411407|NCT01170598|Secondary|Fatigue|Fatigue will be assessed using the Functional Assessment of Cancer Therapy fatigue subscale (FACT-Fatigue). The FACT-Fatigue consists of 13 questions and has excellent psychometric characteristics. Fatigue scores derived from this questionnaire range from 0-52 with a higher score reflecting lower fatigue.|Baseline, Post-induction (weeks 4-6)||||units on a scale||Standard Deviation|Mean
1411408|NCT01170598|Secondary|Global Quality of Life|Global quality of life (QOL) will be measured by the European Organization for the Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30). The EORTC QLQ-C30 is a widely used, self-reported, psychometrically sound cancer QOL instrument. QOL scores derived from this questionnaire range from 0-100 with a higher score reflecting a higher QOL.|Baseline, Post-induction (weeks 4-6)||||units on a scale||Standard Deviation|Mean
1411409|NCT01170598|Primary|Grip Strength|Measure of upper-body strength using a Jamar hand dynamometer. Participants were asked to hold and squeeze (the dynamometer) with maximal force. Three trials were completed with each hand, alternating between the right and left to minimize fatigue. The highest recorded value of the dominant hand was used in the analysis.|Baseline, Post-induction (weeks 4-6)||||kilograms||Standard Deviation|Mean
1411410|NCT01170598|Primary|Timed 10-chair Stands|Measure of lower-body strength completed by standing from a seated position 10 times as quickly as possible.|Baseline, Post-induction (weeks 4-6)||||seconds||Standard Deviation|Mean
1413690|NCT01152359|Secondary|Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire||48 weeks|||||||
1411411|NCT01170598|Primary|6-minute Walk Test|Measure of functional endurance assessed by the walking distance covered in a 6-minute period. Participants walk a pre-established course for a total of 6 minutes. The distance covered in that time is recorded as the 6-minute walk test score.|Baseline, Post-induction (4-6 weeks)||||feet||Standard Deviation|Mean
1411412|NCT01170598|Primary|Peak Aerobic Capacity (VO2peak)|The modified Bruce protocol is a walking-based treadmill test used to assess peak aerobic capacity. As the test progresses the intensity of each 3-minute work load increases. The test concludes when the participant reaches his maximal heart rate or volitional fatigue. The value attained on this test is measured in metabolic equivalents (METS). METS are a measure of exercise intensity and reflect the physical demands of an activity. In this context, a higher value achieved on the treadmill test (in METS) indicates work at a higher intensity and therefore a higher aerobic capacity.|Baseline, Post-induction (weeks 4-6)||||metabolic equivalent (METS)||Standard Deviation|Mean
1411413|NCT01170546|Primary|Age||before training||||year||Standard Deviation|Mean
1411414|NCT01170546|Primary|Isokinetic Strength|Cybex NORM (Cybex International, Inc, Ronkonkoma, New York, U.S.A.) was employed to evaluate isokinetic muscle strength before and after training.|one year||2010-12-31|12/2010||||
1411415|NCT01170546|Primary|Agility|shuttle run agility test|one year||2010-12-31|12/2010||||
1411416|NCT01170546|Primary|Static Knee Stability|The KT-2000 knee ligament arthrometer (MED Metric Co., San Diego, USA) is designed to assess the anterior drawer laxity of the knee joint. The discrepancy of anterior displacement between the sound side and the lesion side is applied in evaluating the static stability of the knee.|one year||2010-12-31|12/2010||||
1411417|NCT01170533|Primary|Platelet Function as Assessed by the P2Y12 Reactivity Index|P2Y12 reactivity index which will be assessed by flow cytometry determination of vasodilator-stimulated phosphoprotein (VASP).|1 week|A sample size of 18 patients was required to be able to detect a 10% absolute difference in PRI between both regimens with 80% power and 2-sided significance level of 0.05, assuming a 15% standard deviation for the difference between regimens.|||Percentage of platelet reactivity index||Standard Error|Least Squares Mean
1411418|NCT01170390|Secondary|EE Steady State After Randomization|Steady state levels of ethinyl estradiol (EE) post- randomization|Post-randomiziation 4 months||||ng/mL||Standard Deviation|Mean
1411419|NCT01170390|Secondary|EE Steady State Baseline|Steady state levels of ethinyl estradiol (EE) at baseline (2 months)|Baseline (2 months)|One subject discontinued prior to the completion of the baseline cycle in the Aviane/Aviane arm|||ng/mL||Standard Deviation|Mean
1411420|NCT01170390|Secondary|LNG AUC|Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2.|baseline (2 months)||||hr*ng/mL||Standard Deviation|Mean
1411421|NCT01170390|Secondary|LNG AUC|Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn.|post-randomization (4 months)||||hr*ng/mL||Standard Deviation|Mean
1411422|NCT01170390|Primary|LNG Steady State at Baseline and Then Post-randomization|The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control).|baseline (2 months) and post-randomization (4 months)|One subject discontinued prior to the completion of the baseline studies in the Aviane/Aviane arm|||ng/mL||Standard Deviation|Mean
1411423|NCT01170364|Primary|24 Hour Measured Caloric Intake|The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.|1 week|This is a cross over design study. All participants received sibutramine and placebo. The sibutramine arm listed here includes all participants who received sibutramine (regardless of whether they received it first or second). The placebo arm included all those who received placebo (regardless of whether they received it first or second).|||kcal||Standard Deviation|Mean
1411424|NCT01170273|Primary|Change in Short Physical Performance Battery Test Score|The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.|baseline and 9 months||||units on a scale||Standard Deviation|Mean
1411425|NCT01170247|Primary|Onset of Sedation|Minutes it takes until the patient is cooperative enough for the procedure|Every 60 seconds through study completion||||Participants|||Count of Participants
1411426|NCT01170221|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.|||units on a scale||Standard Deviation|Mean
1411427|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the Day 7 Visit|Clinical improvement was defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
1411428|NCT01170221|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement was defined as improvement in overall clinical status.|48-72 Hour Visit|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
1411447|NCT01170039|Secondary|Efficacy, Measured by the Duration of Colonic Transit Time as Measured by the SmartPill pH Capsule|The duration of colonic transit time in hours was measured by the SmartPill pH Capsule. Colonic transit time is the time interval from the cecal entry of the capsule to anal expulsion and was measured in hours.|Baseline, 4 weeks|Intention to treat population.|||hours||Standard Deviation|Mean
1411737|NCT01167829|Primary|Mean Testosterone Concentration|initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1411429|NCT01170221|Secondary|To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized patients who received the minimal study therapy, completed EOT and PTE assessments, no concomitant systemic antibiotic therapy through PTE, and had no confounding events or factors.|||participants|||Number
1411430|NCT01170221|Secondary|Investigator’s Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set included data from all randomized participants.|||participants|||Number
1411431|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|EOT Day 11|All randomized patients receiving minimal study therapy, completed 48-72 Hour and EOT assessments, no concomitant systemic antibiotic therapy through EOT, and had no confounding events or factors|||participants|||Number
1411432|NCT01170221|Secondary|Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.|Day 11|The ITT analysis set includes data from all randomized participants.|||participants|||Number
1411433|NCT01170221|Primary|Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C|48-72 hours|The ITT analysis set includes data from all randomized participants.|||Responders|||Number
1411434|NCT01170208|Secondary|Incidence of Severe or Serious Hypoglycemia.||January 2011|||||||
1411435|NCT01170208|Secondary|Reduction in Fructosamine.||January 2011|||||||
1411436|NCT01170208|Secondary|Reduction in HbA1c.||January 2011|||||||
1411437|NCT01170208|Secondary|Clinical Evaluation of ―Over-ride‖ to Determine if the Reason for ―Over-ride‖ Will Affect a Change in the Algorithm.||January 2011|||||||
1411438|NCT01170208|Primary|Weekly Mean Blood Glucose||Twelve week period from week 4 to week 16|Per Protocol|||mg/dL||Standard Deviation|Mean
1411439|NCT01170117|Primary|Psychological Change|Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe.|Weekly during 16-week intervention and twice during 8-week follow-up||||YBOCs score units per month||Standard Deviation|Mean
1411440|NCT01170117|Primary|Rate of Weight Change|Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo|Weekly during 16-week trial and twice during 8 weeks follow-up|Patients assigned to receive placebo or olanzapine for 16 weeks.|||kg/m^2 per month||Standard Error|Mean
1411441|NCT01170091|Secondary|Clinical Global Impressions-Global Improvement (CGI-I)|"CGI-I comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose CGI-I were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)|||patients|||Number
1411442|NCT01170091|Secondary|Patient-Global Impressions (PGI-I)|"PGI comprises of 7 categories including very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse."|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose PGI were assessed at the baseline and at 4 weeks after the end of titration. Efficacy Data Set (Intent to Treat)|||patients|||Number
1411443|NCT01170091|Secondary|International Restless Legs Syndrome Rating Scale (IRLS) Change After 4 Weeks of Mirapex Treatment|"a change in 10-item scale rated by the patient on 5 levels with a minimum (none) sum score of 0 to maximum (very severe) sum score of 40"|before and after the treatment with Mirapex (at least 4 weeks after the end of titration)|Patients whose IRLS scores were assessed at the baseline and at 4 weeks after the end of titration. Efficacy data set (Intent to Treat)|||Units on a scale||Standard Deviation|Mean
1411444|NCT01170091|Primary|Number of Reported Adverse Events|If there is a dose titration, another 4 weeks should be followed up|Up to 4 weeks|Patients with RLS who took at least one dose of Mirapex - Safety Analysis Set|||cases|||Number
1411445|NCT01170039|Secondary|Change in Scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire|The difference in the scores on the self-reported Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The quality of life is measured by the by the overall scores on the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, a validated 28-item questionnaire measuring quality of life as it pertains to constipation. The 28 items are grouped into four subscales, 1) worries and concerns, 2) physical discomfort, 3) psychosocial discomfort, and 4) satisfaction. A 5-point Likert response scale, ranging from 0 (Not at all/None of the time) to 4 (Extremely/ All of the time), is used. The subscale scores vary from 0 to 4 and the total (global) score ranges from 0 to 4. A lower score indicates better quality of life (QOL).|Screening, 8 weeks|7 subjects in the Lubiprostone arm and 7 subjects in the placebo arm did not complete the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire and therefore no data was analyzed for these subjects.|||scores on a scale||Standard Deviation|Mean
1411446|NCT01170039|Secondary|Number of Subjects With Daily Abdominal Discomfort|The number of subjects experiencing abdominal discomfort was recorded weekly.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|The number of participants in both arms was analyzed by Intention-to-Treat (ITT).|||participants|||Number
1411448|NCT01170039|Primary|Efficacy, Measured by the Average Number of Spontaneous Bowel Movements (SBMs) Per Week|The average number of spontaneous bowel movements calculated per week from baseline to 8 weeks was recorded. The number of spontaneous bowel movements was recorded by the subjects in a daily stool diary and the weekly average was calculated. Spontaneous bowel movements are bowel movements within a 24 hour period independent of rescue medication use within the previous week.|1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks|Two subjects in the Lubiprostone arm did not complete the daily stool diary at baseline. No data was analyzed for these two subjects.|||spontaneous bowel movements||Standard Deviation|Mean
1411449|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|Activity impairment due to psoriasis (the extent to which psoriasis affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of activity impairment||Standard Deviation|Mean
1411450|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status|The mean percentage of TWPI due to psoriasis (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which psoriasis decreased productivity (%)* [number of hours worked / (number of hours of work missed due to psoriasis + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any data follow-up were available; n=number of participants with an assessment at given time point.|||percentage of TWPI||Standard Deviation|Mean
1411451|NCT01169987|Secondary|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Presenteeism (the extent to which psoriasis decreased productivity) is presented as the mean percentage of impairment while working due to psoriasis, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.|||percentage of impairment while working||Standard Deviation|Mean
1411452|NCT01169987|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status|Absenteeism, presented as the mean percentage of work time missed due to psoriasis (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with assessment at given time point.|||percentage of work time missed||Standard Deviation|Mean
1411477|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)|Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP). A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||ng/ml||Standard Deviation|Mean
1411453|NCT01169987|Secondary|DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI is a participant-reported outcome consisting of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect. Follow-up visits were classified into time windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of participants|||Number
1411454|NCT01169987|Secondary|Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (3), a lot (2), a little (1), or not at all (0). The total DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows, based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
1411455|NCT01169987|Secondary|Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status|"The PGA was an evaluation of a participant's psoriasis on a 6-point scale: clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5), which were then regrouped into the 2 categories Clear/Minimal or Mild/Moderate/Severe/Very Severe (M/Md/S/VS), and presented as the percentage of participants in each. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)."|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (obs.; up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of participants|||Number
1411456|NCT01169987|Secondary|Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status|Clinical psoriasis evaluations by the investigator of percentage of affected BSA. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of affected BSA||Standard Deviation|Mean
1411457|NCT01169987|Secondary|PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Percentage of participants who achieved ≥ 50%, 75%, 90% or 100% reduction (improvement) from Baseline in PASI score (PASI50, PASI75, PASI90, PASI100). Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based on the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at given time point.|||percentage of participants|||Number
1411478|NCT01169701|Secondary|Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)|Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||mL/min/1.73m^2||Standard Deviation|Mean
1411458|NCT01169987|Secondary|Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status|Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed with PASI for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline – score at follow-up visit) / PASI score at Baseline. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730).|Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|ITT set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available; n=number of participants with an assessment at Baseline and given time point.|||percentage improvement||Standard Deviation|Mean
1411459|NCT01169987|Primary|Adalimumab Treatment Retention Status|Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for < 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups.|Month 24/ Early Termination visit|Intention to Treat (ITT) set: all participants enrolled in the study who received at least 1 dose of adalimumab, and for whom any follow-up data were available.|||percentage of participants|||Number
1411460|NCT01169779|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1411461|NCT01169779|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >250 milligram/deciliter (mg/dL) (13.9 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >220 mg/dL (12.2 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1411462|NCT01169779|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1411463|NCT01169779|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with Baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1411464|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1411465|NCT01169779|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1411466|NCT01169779|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1411467|NCT01169779|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1411468|NCT01169779|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting Baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1411469|NCT01169779|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline on-treatment assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1411470|NCT01169753|Primary|"Number of Participants With Fatigue Worst BFI Score"|"Efficacy defined by fatigue worst score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue."|After each 2 week treatment|No analysis completed, study stopped due to slow accrual with only one participant.||||||
1411471|NCT01169701|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up|The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.|Month 24|Intent to Treat (ITT): The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.|||Percentage of participants|||Number
1411472|NCT01169701|Secondary|Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)|Blood samples were collected to analyze CRP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||mg/dl||Standard Deviation|Mean
1411473|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)|Blood samples were collected to analyze PCR. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||ug/l||Standard Deviation|Mean
1411474|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)|Blood samples were collected to analyze NT-proBNP. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||pg/mL||Standard Deviation|Mean
1411475|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)|Blood samples were collected to analyze MPO. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||U/mL||Standard Deviation|Mean
1411476|NCT01169701|Secondary|Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)|Blood samples were collected to analyze HbA1c. A negative change from baseline indicates improvement.|Baseline, month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||Percentage of HbA1c||Standard Deviation|Mean
1411479|NCT01169701|Secondary|Renal Function as Measured by Creatinine Clearance|Creatinine clearance was calculated using the Cockroft-Gault formula.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||mg/min||Standard Deviation|Mean
1411480|NCT01169701|Secondary|Renal Function Measured by Serum Creatinine|Serum samples were collected to analyze serum creatinine.|Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||mg/dl||Standard Deviation|Mean
1411481|NCT01169701|Secondary|Percentage of Participants With Major Cardiovascular Events (MACE)|The percentage of participants who experienced MACE were reported. MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.|Month 24|The Intent to Treat (ITT) analysis set: The ITT included participants who received at least one dose of study medication and had at least one post baseline LVMI value.|||Percentage of participants|||Number
1411482|NCT01169701|Secondary|Pulse Wave Velocity (PWV)|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|Month 6, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.|||m/sec||Standard Deviation|Mean
1411483|NCT01169701|Secondary|Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure|Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.|Baseline, Month 6, month 12, month 24|Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.|||mmHg||Standard Deviation|Mean
1411484|NCT01169701|Primary|Change From Baseline in Left Ventricular Mass Index (LVMI)|Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women. A negative change from baseline indicates improvement.|Baseline, Month 24|Participants from the Intent to Treat (ITT) analysis set, who had both baseline and month 24 values, were analyzed. The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.|||g/m^2.7||Standard Deviation|Mean
1411485|NCT01169675|Secondary|Tumour Shrinkage|Tumour shrinkage is defined as the maximum percentage decrease from baseline in the sum of the longest diameters of target lesions.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set: all patients that received treatment of Afatinib or Pemetrexed and who were evaluated for the longest diameter of the target lesions.|||participants|||Number
1411486|NCT01169675|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first treatment to the occurence of tumour progression or death, whichever came first. It was assessed according to RECIST version 1.1 criteria.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||months||95% Confidence Interval|Median
1411487|NCT01169675|Secondary|Disease Control|Disease Control is defined as complete response, partial response, or stable disease according to the response evaluation criteria in solid tumours (RECIST) version 1.1.|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||participants|||Number
1411488|NCT01169675|Secondary|Objective Response (OR)|"Objective Response is defined as complete response or partial response according to the response evaluation criteria in solid tumours (RECIST) version 1.1.~Complete Response (CR): disappearance of all non-target lesions and normalization of tumor marker level; Partial Response (PR): at least 30% decrease of the sum of longest diameter (LD) of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions together with an absolute increase in the sum of LD of at least 5 millimeters; Stable Disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD."|Every 6 weeks before week 48 and every 12 weeks after week 48 until progression|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||participants|||Number
1411489|NCT01169675|Secondary|Investigator Defined Dose Limiting Toxicity (DLT) During All Courses of Treatment, Treated Set|Occurence of DLT during all courses of treatment with Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during all cycles of treatment|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed|||participants|||Number
1411490|NCT01169675|Primary|Investigator Defined Dose Limiting Toxicity (DLT) During First Course of Treatment, Treated Set|Occurence of DLT during the first course of treatment to determine the maximum tolerated dose (MTD) of Afatinib at two different dose schedules in combination with the standard established dose of pemetrexed (500 mg/m2).|DLT were assessed during the first cycle (days 1-21)|Treated Set includes all patients that received treatment of Afatinib or Pemetrexed that who were evaluable for MTD determination|||participants|||Number
1411491|NCT01169649|Primary|Overall Response.|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|every 12 weeks||||participants|||Number
1411492|NCT01169610|Secondary|Tolerability|Tolerability will be defined by the number of adverse events experienced by patients.|Two years|||||||
1411525|NCT01169311|Secondary|Length of Stay|length of time between time of admission and time of discharge|Day 0, time of discharge minus time of admission||||Minutes||Standard Deviation|Mean
1411493|NCT01169610|Secondary|Prolonged Smoking Abstinence|"Self-reported all tobacco abstinence since two weeks after target quit date (TQD) which will be during their 28-day stay in the IAP on day 8 of varenicline therapy. Negative response to the question, “Have you used any type of tobacco, even a puff, for 7 consecutive days or at least once each week on two consecutive weeks since xx/xx/xxxx?” Note: xx/xx/xxxx corresponds to the date two weeks after the target quit date (TQD).~Biochemically-confirmed abstinence at the visit for which prolonged abstinence is being obtained."|Two years|||||||
1411494|NCT01169610|Secondary|7-day Point Prevalence Smoking Abstinence|Negative response to the question, “Have you used any type of tobacco, even a puff, in the past 7 days.” This will be a self-reported outcome biochemically-confirmed with exhaled-air carbon monoxide (CO) < 8 parts per million (ppm) during the medication phase.|Two years|||||||
1411495|NCT01169610|Primary|Heavy Drinking Days|Number of drinking days > 5 drinks/day for men and > 4 drink/day for women. This will be a self-reported outcome.|Two years|||||||
1411496|NCT01169610|Primary|Continuous Alcohol Abstinence|No consumption of alcohol (not even a single drink) during the specified interval of time. This will be a self-reported outcome.|Two years|||||||
1411497|NCT01169558|Secondary|Efficacy: Progression-free Survival|Progression-free survival (PFS) was measured as the time from start of first bevacizumab administration to investigator-assessed progression or death, whichever occurred first. Progression was defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Reported is the median time of PFS.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.|||months||95% Confidence Interval|Median
1411498|NCT01169558|Secondary|Efficacy: Time to Disease Progression|Time to disease progression was measured as the time from start of first bevacizumab administration to investigator-assessed progression. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. For participants without disease progression at the end of the study, date and time to progression were censored at the last investigator assessment. Reported is the median time to disease progression.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.|||months||95% Confidence Interval|Median
1411499|NCT01169558|Secondary|Efficacy: Overall Survival|Overall survival was measured as the time from start of first bevacizumab administration to death. For participants who were alive at the end of the study, data on survival were censored at the time of the last contact. Reported is the median duration of overall survival.|Up to approximately 3 years|158 participants from the ITT population were included in the analysis. Four participants were excluded from the ITT population due to protocol deviation.|||months||95% Confidence Interval|Median
1411500|NCT01169558|Primary|Safety: Number of Participants With Serious and Specific Adverse Events|A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.|Up to approximately 3 years|The intent to treat (ITT) population included all participants receiving at least one dose of the study drug. This population was primarily used for the reporting of safety information.|||participants|||Number
1411501|NCT01169519|Secondary|Hemodynamic Safety and Efficacy|Assessment of pulmonary vascular resistance|10 minutes after completion of sildenafil infusion||||Wood units * m^2||Inter-Quartile Range|Median
1411502|NCT01169519|Primary|Maximum Sildenafil Plasma Concentration|Assessment of peak sildenafil plasma concentration.|5 minutes after completion of sildenafil infusion|3 patients were enrolled in this group but in 1 participant, an inadequate plasma sample volume prevented accurate determination of sildenafil concentration.|||ng/mL||Standard Deviation|Mean
1411503|NCT01169493|Secondary|Left Ventricular End-diastolic Size||6 months|Data not collected.|||cubic cm||Standard Error|Mean
1411504|NCT01169493|Secondary|Left Ventricular Ejection Fraction (LVEF)||6 months|Data not collected.|||percent||Standard Deviation|Mean
1411505|NCT01169493|Secondary|NYHA Function Class|The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.|6 months||||units on a scale||Standard Deviation|Mean
1411506|NCT01169493|Secondary|6-minute Walk Distance|6-minute walk distance was the distance that a participant could walk in 6 minutes.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||meters||Standard Deviation|Mean
1411507|NCT01169493|Secondary|Minnesota Quality of Life Questionnaire|This is a standardized method for assessing quality of life in patients with heart failure. It asks 21 questions and measures the impact HF has on a subject's life. Each question is rated 0-5. The total score for the 21 items can range from 0 to 105. Higher scores indicate more burden of disease on quality of life.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||units on a scale||Standard Deviation|Mean
1411526|NCT01169311|Secondary|Intra-Operative Bleeding Requiring Intervention|Incidence of intervention for intra-operative staple-line bleeding|Day 0 - time of surgery||||participants|||Number
1411527|NCT01169311|Secondary|OR Time|Duration of procedure|Day 0 - Time of stop minus time of start||||minutes||Standard Deviation|Mean
1423336|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S- Calcium|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
1411508|NCT01169493|Secondary|Arrhythmic Events|To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments. An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.|6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||participants|||Number
1411509|NCT01169493|Secondary|Secondary Echocardiographic Endpoints|Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.|6 months|Data not collected.||||||
1411510|NCT01169493|Primary|The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.||6 months|All participants who completed the six month period for VVI-40, RV DDD-40, Bi-V DDD-40 regardless of which arm they are randomized to. Participants may be counted as completing more than one period.|||percentage of participants|||Number
1411511|NCT01169467|Secondary|Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury|Improved physiologic Response. A lower variability of mean Arterial Blood pressure during treatment would be considered an improved physiologic response. A higher variability of mean Arterial Blood pressure during treatment would be considered a worse physiologic response. Variability was assessed and listed as the standard deviation of all measurements within 24 hours.|Baseline to 24 hours|Everyone who started the trial was included except for seventeen subjects had incomplete data and could not be included in this analysis.|||mmHg||Standard Error|Mean
1411512|NCT01169467|Secondary|Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury|Improved physiologic Response. A higher cerebral perfusion pressure during treatment would be considered an improved physiologic response. A lower cerebral perfusion pressure during treatment would be considered a worse physiologic response.|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.|||mmHg||Standard Error|Mean
1411513|NCT01169467|Secondary|Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury|Improved physiologic Response. A lower use of sedatives or analgesic during treatment would be considered an improved physiologic response. An increase in the use of sedatives or analgesic during treatment would be considered a worse physiologic response.|24 hours|Everyone who started the trial was included except for one subject had incomplete data and could not be included in this analysis.|||mg/ml||Standard Error|Mean
1411514|NCT01169467|Primary|Change in Pressure Reactivity Index (PRx)|"Using computational methods, the PRx was determined by calculating the correlation coefficient between 20 consecutive, time-averaged data points (60-second periods) of ICP and Arterial Blood Pressure (ABP).~A positive PRx correlation suggests impaired cerebrovascular pressure reactivity, that is, passive transmission of changes in ABP to ICP. A negative PRx correlation indicates good pressure reactivity. Any change in ABP produces inverse changes in ICP."|Baseline to 24 hours|Everyone who completed the trial was included except for nineteen subjects had incomplete data and could not be included in this analysis.|||Pressure Reactivity Index||Standard Error|Mean
1411515|NCT01169467|Primary|Variability of Intracranial Pressure (ICP)|Variability of intracranial pressure was assessed and listed as the standard deviation of all measurements within 24 hours. Variability was assessed and listed as the standard deviation of all measurements within 24 hours|Baseline to 24 hours|Everyone who completed the trial was included except for fourteen subjects had incomplete data and could not be included in this analysis.|||mmHg||Standard Error|Mean
1411516|NCT01169350|Secondary|Response to Radiation Therapy (XRT) by RECIST Criteria|Will be approached using multivariate logistic regression.|Up to 2 years|Study ended. No patients were assessed for response to radiation therapy (XRT) by RECIST criteria. No data were collected for this assessment.||||||
1411517|NCT01169350|Secondary|Disease Free Survival|Multivariate Cox regression will be used.|From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years|Study ended. No patients were assessed for disease free survival.No data were collected for this assessment||||||
1411518|NCT01169350|Secondary|Overall Survival|Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.|Up to 2 years|Study ended. No patients were assessed for overall survival.No data were collected for this assessment.||||||
1411519|NCT01169350|Primary|Changes From Baseline Hypoxic Volume (HV)|ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.|Baseline and up to 2 years|Study ended with 8 patients imaged at baseline and only 3 patients had 18F FMISO following therapy.|||Cm^3||Standard Deviation|Mean
1411520|NCT01169311|Secondary|Quality of Life, Mental Component|quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation|Baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.|||units on a scale||Standard Deviation|Mean
1411521|NCT01169311|Secondary|Quality of Life, Physical Component|Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation|baseline, 30 days post op|Only subjects who completed the SF-36 questionnaire were included in the analysis. The number of participants reflects 24/27 subjects completed the questionnaire.|||units on a scale||Standard Deviation|Mean
1411522|NCT01169311|Secondary|Post Operative Pain|Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain|baseline, 30 days post op||||units on a scale||Standard Deviation|Mean
1411523|NCT01169311|Secondary|Incidence of Stapler Malfunction or Misfires||about 20 minutes for procedure||||participants|||Number
1411524|NCT01169311|Secondary|Time to Return to Normal Activity||30 days post op||||Days||Standard Deviation|Mean
1443750|NCT00906204|Secondary|Acute Kidney Rejection|Kaplan-Meier probability estimates of rejection rates|12 months post-transplantation||||participants|||Number
1411531|NCT01169103|Primary|Changes in Lipid Panel|Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy|Baseline and 6 months||||mg/dL||Standard Deviation|Mean
1411532|NCT01169103|Secondary|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score|Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5]|Baseline and 6 months||||HOMA-IR score||Standard Deviation|Mean
1411533|NCT01169103|Primary|Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months|Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)|Baseline and 6 months|Due to scheduling difficulties one no treatment subject did not perform the MRI portion of the study at either the baseline or the 6 month visit.|||mm^2||Standard Deviation|Mean
1411534|NCT01169064|Secondary|Patient Dressing Cost|Total cost of dressings per group based on 1 dressing per patient|Postoperative||||dollars|||Number
1411535|NCT01169064|Secondary|Infection Rate Adjusted for Maternal BMI||6 weeks postpartum||||percentage of participants||95% Confidence Interval|Number
1411536|NCT01169064|Primary|Silver Treatment Efficacy|As measured by number of patients with postop infections at 6 wks|6 weeks postpartum||||participants|||Number
1411537|NCT01169038|Primary|Change in Absolute FVC From Baseline to Post Completion of 8 Weeks of Antibiotic Therapy.|The primary endpoint was improvement in absolute FVC from baseline to completion of therapy. Spirometry testing was performed using a standardized calibrated laptop spirometer, Flowscreen II USA Spirometer (VIASYS Healthcare Inc., Yorba Linda, CA). The volume accuracy of the spirometer was checked daily using a three liter calibration syringe. Each subject was given at least three attempts and the greatest measurement for absolute FVC and Forced Expiratory Volume (FEV1) at baseline, four week, and eight week assessments was recorded.|8 weeks|In the ITT analysis, we included the values from the last measured value for those who did not complete the trial. We analyzed the measured value at 8 weeks among those subjects who completed 8 weeks of therapy in the per protocol analysis.|||liters||Standard Deviation|Mean
1411538|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Left Sidebending Range of Motion|Low back left sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
1411539|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Right Sidebending Range of Motion|Low back right sidebending range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
1411540|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Extension Range of Motion|Low back extension range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
1411541|NCT01168999|Secondary|Change From Baseline at 2 Weeks in Low Back Flexion Range of Motion|Low back flexion range of motion was measured in degrees using a gravity inclinometer|Change from Baseline at 2 weeks||||degrees||Standard Deviation|Mean
1411542|NCT01168999|Primary|Change in Pain Sensitivity From Baseline to Immediately Following the Assigned Intervention as Measured by a Visual Analog Scale|"Participants received a standard thermal stimulus to the bottom of their foot prior to and immediately following their assigned intervention. Participants rated their pain in response to this thermal stimulus using a 101 mm visual analog scale with 0 mm indicating no pain at all and 100 mm indicating the worst pain imaginable."|baseline and immediately following their assigned intervention during the initial session||||units on a scale||Standard Deviation|Mean
1411543|NCT01168999|Primary|Change From Baseline at 2 Weeks in Disability as Measured by the Oswestry Disability Index|The Oswestry Disability Index is a 10 item questionnaire measuring low back pain related disability. Individual item scores range from 0 to 5. Scores on all items are summed and multiplied by 2 to provide a percentage ranging between 0 to 100 with higher scores indicating greater low back pain related disability.|Change from Baseline at 2 weeks||||units on a scale||Standard Deviation|Mean
1411544|NCT01168999|Primary|Change From Baseline at 2 Weeks in Clinical Pain as Measured by a Numeric Rating Scale|A 101 point numeric rating scale with 0= no pain at all to 100= worst pain imaginable of low back pain|Change from Baseline at 2 weeks||||units on a scale||Standard Deviation|Mean
1411545|NCT01168999|Primary|Expectation for Treatment Effectiveness|how helpful participants expect the assigned intervention will be in decreasing their low back pain|baseline||||percent expecting less pain|||Number
1411546|NCT01168999|Primary|Believability of Placebo|Assess whether or not participants receiving the placebo are blinded to the fact they are receiving the placebo as indicated by the percentage of participants in each arm of the study believing they received SMT|baseline||||percentage of participants|||Number
1411547|NCT01168986|Secondary|Change From Baseline in Neck Extension Range of Motion at 2 Weeks|change in neck extension range of motion over a 2 week period|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||degrees||Standard Deviation|Mean
1411548|NCT01168986|Primary|Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale|Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.|Immediate within session change pre to post intervention|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||units on a scale||Standard Deviation|Mean
1411549|NCT01168986|Primary|2 Week Change in Disability on the Neck Disability Index|A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||2 week change in units a scale||Standard Deviation|Mean
1411550|NCT01168986|Primary|2 Week Change in Pain Score on a Numeric Rating Scale|a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable|2 weeks|The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data|||units on a scale||Standard Deviation|Mean
1411551|NCT01168973|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died|Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Safety population: Randomized participants who received any quantity of study drug, grouped by the treatment they actually received.|||participants|||Number
1411552|NCT01168973|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.|Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants who received any quantity of study treatment, grouped by the treatment they actually received, who had a baseline and at least 1 post-baseline ADA assessment.|||participants|||Number
1411553|NCT01168973|Secondary|Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab||Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)|Participants assigned to the ramucirumab and docetaxel arm at randomization, who had evaluable ramucirumab pharmacokinetic (PK) data to calculate Cmax and Cmin.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1411554|NCT01168973|Secondary|Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores|The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had an EQ-5D assessment at a baseline and 30 days post treatment.|||units on a scale||Standard Deviation|Mean
1411555|NCT01168973|Secondary|Maximum Improvement on Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Randomized participants grouped according to their assigned treatment at randomization, who had a baseline and at least 1 post-baseline LCSS score.|||mm||Standard Deviation|Mean
1411556|NCT01168973|Secondary|Percentage of Participants Achieving Disease Control (Disease Control Rate)|Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.|||percentage of participants||95% Confidence Interval|Number
1411557|NCT01168973|Secondary|Percentage of Participants Achieving an Objective Response (Objective Response Rate)|Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to measured PD (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization.|||percentage of participants||95% Confidence Interval|Number
1411558|NCT01168973|Secondary|Progression-Free Survival (PFS) Time|PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Randomization to measured PD or date of death from any cause (up to 29 months)|ITT population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 70 participants; placebo and docetaxel arm = 42 participants.|||months||95% Confidence Interval|Median
1411559|NCT01168973|Primary|Overall Survival|Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Randomization to date of death from any cause (up to 34 months)|Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization. Participants censored: ramucirumab and docetaxel arm = 200 participants; placebo and docetaxel arm = 169 participants.|||months||95% Confidence Interval|Median
1411560|NCT01168934|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1411561|NCT01168934|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time (MRAUC [0-∞])|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) (MRAUC [0-∞]).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||Ratio||Standard Deviation|Geometric Mean
1411562|NCT01168934|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1411563|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1411564|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1411565|NCT01168934|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the ‘N = 13’ is signifying those participants who were evaluable for this measure at the specified time point for this arm group.|||ng*hr/mL||Standard Deviation|Geometric Mean
1411566|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1411567|NCT01168934|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
1423337|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Potassium|Change from baseline|Baseline and 52 week after||||mEq/L||Standard Deviation|Mean
1411568|NCT01168934|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
1411569|NCT01168934|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1411570|NCT01168934|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1411571|NCT01168934|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1411572|NCT01168934|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1411573|NCT01168934|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1411574|NCT01168934|Secondary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn])|AUClast[dn] = Dose normalized area under the plasma concentration time-curve (AUC[dn]) from zero to the last measured concentration.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL/mg||Standard Deviation|Geometric Mean
1411575|NCT01168934|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1411576|NCT01168934|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1411577|NCT01168934|Primary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞][dn])|AUC [0 - ∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - ∞) divided by dose.|0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL/mg||Standard Deviation|Geometric Mean
1411578|NCT01168908|Secondary|Ejection Fraction||6 months|||||||
1411579|NCT01168908|Secondary|Change in Skeletal Muscle Strength|Skeletal muscle strength will be assessed by pincher and grip dynamometry|6 months and 12 months||||pounds||Standard Deviation|Mean
1411580|NCT01168908|Secondary|Change in Forced Vital Capacity (FVC) by Pulmonary Function Testing|Skeletal muscle function of the diaphragm will be measured using FVC by pulmonary function testing.|6 months and 12 months||||liters||Standard Deviation|Mean
1411581|NCT01168908|Secondary|Change in Cardiac Mass|Left ventricular (LV) mass will be measured by CMR .|6 months and 12 months||||grams||Standard Deviation|Mean
1411582|NCT01168908|Secondary|Change in Cardiac Systolic and Diastolic Function by CMR|Cardiac volumes and systolic ejection parameters will be measured.|6 months and 12 months||||ml||Standard Deviation|Mean
1411593|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.|||Beats per minute||Standard Deviation|Mean
1411583|NCT01168908|Primary|Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging.|To determine whether a 6 month trial of oral sildenafil compared to placebo improves cardiac contractile function in DBMD as determined by a > 10% decline in end-systolic volume as detected by CMR.|6 months compared to baseline||||ml||Standard Deviation|Mean
1411584|NCT01168856|Primary|Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688|Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.|Month 18|Resistance monitoring population.|||participants|||Number
1411585|NCT01168856|Primary|Number of Participants With STV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.~Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.~Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.|||participants|||Number
1411586|NCT01168856|Primary|Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.|||participants|||Number
1411587|NCT01168856|Primary|Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688."|Month 3-18|Resistance monitoring population.|||participants|||Number
1411588|NCT01168856|Primary|Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.|||participants|||Number
1411589|NCT01168856|Primary|Number of Participants With DNV Resistance Status-Clonal Sequencing|"Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.~Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.~Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.~Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study."|Month 3-18|Resistance monitoring population.|||participants|||Number
1411590|NCT01168856|Primary|Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing|"Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.~Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.~Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis."|Month 3-18|Resistance monitoring population.|||participants|||Number
1411591|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.|||Beats per minute||Standard Deviation|Mean
1411592|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.|||Beats per minute||Standard Deviation|Mean
1411594|NCT01168856|Primary|Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.|||Beats per minute||Standard Deviation|Mean
1411595|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.|||mmHg||Standard Deviation|Mean
1411596|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.|||mmHg||Standard Deviation|Mean
1411597|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.|||mmHg||Standard Deviation|Mean
1411598|NCT01168856|Primary|Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.|||mmHg||Standard Deviation|Mean
1411599|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.|||mmHg||Standard Deviation|Mean
1411600|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.|||mmHg||Standard Deviation|Mean
1411601|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.|||mmHg||Standard Deviation|Mean
1411602|NCT01168856|Primary|Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.|||mmHg||Standard Deviation|Mean
1411603|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.||||||
1411604|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.||||||
1411605|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.||||||
1411606|NCT01168856|Primary|Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.|||IU/mL||Standard Deviation|Mean
1411607|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 36|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.|||Percentage of participants|||Number
1411608|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 24|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.|||Percentage of participants|||Number
1411609|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.|||Percentage of participants|||Number
1411610|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.|||Percentage of participants|||Number
1411611|NCT01168856|Primary|Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm|Percentage of participants who received any anti-HCV medication during the monitoring period was reported.|Up to 18 months|Resistance monitoring population.|||Percentage of participants|||Number
1411664|NCT01168427|Secondary|R-wave Amplitude Measurement|Average R-wave amplitude at implant and 30-days post procedure|Implant procedure and 30 days post-implant procedure|||||||
1411612|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 18|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.|||Beats per minute||Standard Deviation|Mean
1411613|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 12|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.|||Beats per minute||Standard Deviation|Mean
1411614|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 9|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.|||Beats per minute||Standard Deviation|Mean
1411615|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 6|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.|||Beats per minute||Standard Deviation|Mean
1411616|NCT01168856|Primary|Mean Pulse Rate in Resistance Monitoring Arm at Month 3|Any abnormalities in pulse rate were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.|||Beats per minute||Standard Deviation|Mean
1411617|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.|||mmHg||Standard Deviation|Mean
1411618|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.|||mmHg||Standard Deviation|Mean
1411619|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.|||mmHg||Standard Deviation|Mean
1411620|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.|||mmHg||Standard Deviation|Mean
1411621|NCT01168856|Primary|Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.|||mmHg||Standard Deviation|Mean
1411622|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.|||mmHg||Standard Deviation|Mean
1411623|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.|||mmHg||Standard Deviation|Mean
1411624|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 9|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.|||mmHg||Standard Deviation|Mean
1411625|NCT01168856|Primary|Systolic Blood Pressure in Resistance Monitoring Arm at Month 6|Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.|||mmHg||Standard Deviation|Mean
1411626|NCT01168856|Primary|Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3|Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.|||mmHg||Standard Deviation|Mean
1411627|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.|||IU/mL||Standard Deviation|Mean
1411628|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.|||IU/mL||Standard Deviation|Mean
1411629|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.|||IU/mL||Standard Deviation|Mean
1411630|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.|||IU/mL||Standard Deviation|Mean
1411631|NCT01168856|Primary|HCV RNA Levels in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 3|Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.|||IU/mL||Standard Deviation|Mean
1411632|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 18|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.|||Percentage of participants|||Number
1411633|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 12|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.|||Percentage of participants|||Number
1411634|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 9|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.|||Percentage of participants|||Number
1411635|NCT01168856|Primary|Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).|Month 6|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.|||Percentage of participants|||Number
1411636|NCT01168856|Primary|Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3|Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).|Month 3|Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.|||Percentage of participants|||Number
1411637|NCT01168726|Secondary|Protective Behavioral Strategies Scale.|Use of protective behavioral strategies related to alcohol use. Higher scores indicate more use of the strategies. A total score was calculated by summing the three subscale scores on the measure (range = 3-18).|6 months||||units on a scale||Standard Deviation|Mean
1411638|NCT01168726|Secondary|Drinking Norms Rating Form|Perceived drinking among other students, represented by standardized scores on the Drinking Norms Rating Form. Higher values indicate that the individual perceives higher levels of drinking among other students. Because the scores are standardized their is no hypothetical minimum or maximum, and the scale is standardized with a mean of 0 and standard deviation of 1. So, a mean value of 1.52 means that participants in that condition had an average score that was 1.52 standard deviation above the overall mean of the sample.|6 months||||units on a scale (standardized)||Standard Deviation|Mean
1411639|NCT01168726|Primary|Rutgers Alcohol Problems Index (RAPI)|Total scores on an alcohol problems scale. Possible score range = 0-92. Higher scores are indicative of more alcohol-related problems.|6 months||||units on a scale||Standard Deviation|Mean
1411640|NCT01168726|Primary|Drinks Per Week||6 Months||||drinks per week||Standard Deviation|Mean
1411641|NCT01168687|Primary|Standard Alcoholic Drinks Per Treatment Period|The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period.|This will be assessed during a 42-day period.|All study participants were used for data analysis. If there were no significant differences between the two doses of levetiracetam, data would be collapsed for analysis.|||number of drinks per treatment period||Standard Error|Mean
1411642|NCT01168674|Secondary|Predictors of Bipolarity to Define the Study Population|The specific bipolarity predictors in patients with MDD were assessed.|13 weeks|The most common predictor was antidepressant tolerance, as reported below in 37 subjects.|||percentage of subjects|||Number
1411643|NCT01168674|Primary|MADRS Improvement Over 6 Weeks|"Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods.~Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms.~Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode.~No subscales were used or combined."|13 weeks (Two 6 week periods plus a one week washout)||||units on a scale||Standard Deviation|Mean
1411644|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tense|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411645|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Happy|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411665|NCT01168427|Secondary|Physician Satisfaction With Reveal In-office Implants|Observational survey of physicians satisfaction post implant At implant|At implant|||||||
1411738|NCT01167829|Primary|Maximum Testosterone Concentration|initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1411646|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Tired|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411647|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Energetic|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411648|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Angry|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411649|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Sad|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411650|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Confused|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411651|NCT01168596|Other Pre-specified|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)|Unified Parkinson's Disease Rating Scale - Motor (UPDRS Part III)is a 14-question inventory measuring the motor functions of patients with Parkinson's Disease. Each subject is rated on a scale of 0 to 4 with the total score from 0 to 56. Higher total scores indicate more impairment of motor function.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411652|NCT01168596|Other Pre-specified|Becks Depression Inventory (BDI-II)|The Becks Depression Inventory (BDI-II) is a 21-question inventory measuring the severity of depression. Each subject is instructed to choose an answer on a scale value of 0 to 3 with the total score from 0 to 63. Higher total scores indicate more severe depressive symptoms.|Change from baseline to week 12||||units on a scale||95% Confidence Interval|Mean
1411653|NCT01168596|Other Pre-specified|State-Trait Anxiety Inventory (STAI)|The State-Trait Anxiety Inventory (STAI) is 40-item psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety. The range for this test is 0 to 160.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411654|NCT01168596|Other Pre-specified|Visual Analog Scale - Subset: Afraid|The Visual Analog Scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The severity of attitude at the time of testing is marked with a cross along a 10 cm line (labeled neutral to afraid, confused, sad, angry, energetic, tired, happy or tense). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptoms-free) to 10 (symptom severe).|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411810|NCT01166997|Primary|Reduction of RV/LV Ratio|Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.|24 hours||||Ratio||Standard Deviation|Mean
1411655|NCT01168596|Other Pre-specified|Marin Apathy Inventory (Apathy Evaluation Scale)|The Marin Apathy Inventory (Apathy Evaluation Scale) is a 14-item inventory measuring apathy of the subject over the past 2 to 4 weeks. Subjects are instructed to choose an answer from 0 to 3: 0=not at all, 1 = slightly, 2 = some, 3 = a lot, to questions related to apathy. The range would be 0 to 42, the higher the score the worse the apathy.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411656|NCT01168596|Other Pre-specified|Parkinson's Disease Sleep Scale (PDSS)|The Parkinson's disease sleep scale (PDSS) is a 15-item visual analogue scale that assesses the profile of nocturnal disturbances in Parkinson's disease patients. The severity of symptoms of sleep over the past week is marked with a cross along a 10 cm line (labeled worst to best state). Responses are quantified by measuring the distance along each line to the intersection with the cross in centimetres, to the nearest 0.1 cm. The scores for each item range from 0 (symptom severe and always experienced) to 10 (symptom-free). The maximum score for PDSS is 150.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411657|NCT01168596|Secondary|Hand-grip Strength|The patients use the hand on the side most affected by Parkinson’s disease to grip the dynamometer with as much strength as they can for 3 consecutive tries. The highest score will be their maximal voluntary contraction (MVC). The subject then rests for 60 seconds. The subject is asked to try to maintain 70% of their MVC and the duration the subject is able to maintain above 50% of their MVC is recorded. Immediately after the maintenance test, the subject performs three more MVCs and each one is recorded. These results are the duration the subject is able to maintain above 50% of their MVC.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||seconds||95% Confidence Interval|Mean
1411658|NCT01168596|Secondary|Finger Tapping|The patient is asked to use the index finger on the side most affected by Parkinson’s disease to tap for sixty seconds with the number of taps at 30 seconds and 60 seconds recorded.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||finger taps per sixty seconds||95% Confidence Interval|Mean
1411659|NCT01168596|Secondary|Paced Auditory Serial Addition Test (PASAT)|The Paced Auditory Serial Addition Test (PASAT) is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention. Where subjects are given a number (every 3 seconds for the first series and 2 seconds for the second series) and are asked to add the number they just heard with the number they heard before. This is a challenging task that involves working memory, attention, and arithmetic capabilities.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411660|NCT01168596|Secondary|PD Quality of Life Scale (PDQ39)|PD Quality of Life Scale (PDQ39) is a 39-item questionnaire, which measures eight dimensions of health (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication and bodily discomfort) over the past 30 days. Dimension scores are coded on a scale of 0 (never) to 5 (always). The higher the score, the worse the quality of life affected by PD. The range for this test is 0 to 195. All eight dimensions are added for a total score.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411661|NCT01168596|Secondary|Multidimensional Fatigue Inventory (MFIS)|The Multidimensional Fatigue Inventory (MFIS) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Subjects are instructed to choose a number from 1 to 5 that indicates their degree of agreement with each statement where 1 indicates that it is true and 5 that it is not true. There are positive and negative statements in the questionnaire. The range is 1 to 100, the higher the number the higher the fatigue.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411662|NCT01168596|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Score consists of a nine-item questionnaire to identify common features of fatigue. Patients are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each statement, where 1 = strongly disagree and 7 = strongly agree. Scores can range from a minimum of 9 to a maximum of 63. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411663|NCT01168596|Primary|Modified Fatigue Impact Scale (MFIS)|The MFIS rates how much of a problem fatigue has caused the subjects during the past month, including the day of testing. It consists of 21 questions of fatigue on quality of life. Each subject is asked to circle the appropriate response for each item: 0=never, 1=rarely, 2=sometimes, 3=often, 4=always, 5=almost always. The minimum score is 0 and the maximum is 105. The higher the score, the more fatigue the subject.|Change from baseline to week 12|The number of patients used to calculate the results for this measure are different from the number of patients listed in the Participant Flow Module because of missing data. Any missing values were omitted from the summaries. Summary measures are for complete data only.|||units on a scale||95% Confidence Interval|Mean
1411668|NCT01168427|Secondary|Number of Participants Having Procedure-related Adverse Events|Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).|From Implant to 90 days post-implant procedure||||participants|||Number
1411669|NCT01168427|Primary|Procedure-related Complications Rate Requiring Resolution by Surgical Intervention|This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.|From Implant to 90 days post-implant procedure|Reveal device indicated patients, enrolled in the study and implanted per protocol|||participants|||Number
1411670|NCT01168349|Secondary|Percentage of Participants With Vitamins Prescription||Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
1411671|NCT01168349|Secondary|Percentage of Participants With Adequate Iron Status|Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
1411672|NCT01168349|Secondary|Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411673|NCT01168349|Secondary|Relative Percent Change in Hb Concentration From Baseline Over the Study Period||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
1411674|NCT01168349|Secondary|Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment||Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
1411675|NCT01168349|Secondary|Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment|Percentage of participants with at least 1 temporary discontinuation was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411676|NCT01168349|Secondary|Percentage of Participants With Modifications of NeoRecormon® Regimen|All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411677|NCT01168349|Secondary|Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU||Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411678|NCT01168349|Secondary|Percentage of Participants With Subcutaneous (SC) Route of Administration||Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
1411679|NCT01168349|Secondary|Percentage of Participants With Pre-specified Dose and Frequency of Injections|Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.|Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure and “n” included participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
1411680|NCT01168349|Secondary|Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks||Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411681|NCT01168349|Secondary|Mean Starting Dose of NeoRecormon® Injection|Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||IU/kg/weeks||Standard Deviation|Mean
1411682|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1411728|NCT01167881|Secondary|The Change in Body Weight From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||kilograms||Standard Error|Mean
1411683|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1411684|NCT01168349|Primary|Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline, Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1411685|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411686|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411687|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6|Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411688|NCT01168349|Primary|Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline|Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411689|NCT01168349|Primary|Mean Number of Days of Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who had at least 1 sick leave without any missing data.|||days||Standard Deviation|Mean
1411690|NCT01168349|Primary|Percentage of Participants With At Least 1 Sick Leave|Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).|Week 4 Up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411691|NCT01168349|Primary|Percentage of Participants With Professional Activity: Baseline|Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411692|NCT01168349|Primary|KPS: Week 24 to 28|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 24 to 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1411729|NCT01167829|Secondary|Free Testosterone Mean Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1411730|NCT01167829|Secondary|Free T Maximum Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1411693|NCT01168349|Primary|KPS: Week 12 to 16|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 12 to 16|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1411694|NCT01168349|Primary|KPS: Week 4 to 6|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Week 4 to 6|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1411695|NCT01168349|Primary|Karnofsky Performance Status (KPS): Baseline|KPS was used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.|Baseline|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
1411696|NCT01168349|Primary|Time to First RBC Transfusions|Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||weeks||95% Confidence Interval|Median
1411697|NCT01168349|Primary|Mean Number of RBC Units|Mean number of units was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.|||RBC units||Standard Deviation|Mean
1411698|NCT01168349|Primary|Mean Number of RBC Transfusions|Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure without any missing data.|||RBC transfusions||Standard Deviation|Mean
1411699|NCT01168349|Primary|Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion|Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Baseline up to Week 28|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants|||Number
1411700|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 21 to 42|Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.|Day 21 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
1411701|NCT01168349|Primary|Percentage of Participants With Early Treatment Response: Day 28 to 42|Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.|Day 28 to 42|Efficacy population. Here “number of participants analyzed” included those participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
1411702|NCT01168232|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1411703|NCT01168232|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1411704|NCT01168232|Primary|Adverse Events (Grade 3 or Higher) During Treatment Period.|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0|During treatment and up to 30 days after stopping the study treatment|Eligible and Treated Participants|||participants|||Number
1411705|NCT01168232|Primary|Objective Tumor Response|Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1.|Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days|Eligible and Treated Patients. Measure of dispersion is 95% One-sided confidence Interval|||percentage||95% Confidence Interval|Number
1411706|NCT01168219|Secondary|Treatment Related Mortality (TRM)|TRM is defined as death within the first six months after transplant not secondary to relapse.|Up to 6 months post-treatment||2019-05-31|05/2019||||
1411707|NCT01168219|Secondary|Overall Survival (OS)|Estimated using the Kaplan-Meier product limit estimator.|Up to 5 years||2019-05-31|05/2019||||
1411727|NCT01167881|Primary|The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.||Baseline and 104 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
1411731|NCT01167829|Secondary|Mean Estradiol Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1411732|NCT01167829|Secondary|Maximum Estradiol Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
1411708|NCT01168219|Primary|Progression-free Survival|"Number of patients who were alive and progression-free at 2 years. >~> AML progression is defined as: >~Reappearance of leukemia blast cells in peripheral blood and > 5% blasts in marrow >~If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow >= 1 week later with > 5% blasts >~Development of extramedullary leukemia >~MDS progression is defined as >~For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts >~For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts >~Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate"|At 2 years|Patients who received transplant were evaluable for the primary endpoint; 3 patients did not and were excluded from this analysis.|||Participants|||Count of Participants
1411709|NCT01168024|Secondary|Change in Kidney Function Between the Randomized Groups.||Up to 96 hours post-procedure|Change in eGFR was available for 2 treatment and 1 control subject. 1 out of range eGFR value for a subject (0.1) was not used as this value is not clinically feasible.|||mL/min/1.73m^2||Standard Deviation|Mean
1411710|NCT01168024|Primary|Evaluating Local Events.|"Events evaluated include:~Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death~Pericardial effusions (including pericardial tamponade) requiring treatment"|Through 30 days post-procedure.||||events|||Number
1411711|NCT01168024|Primary|Evaluating Bleeding/Transfusion Events.|"Bleeding/transfusion events evaluated:~Blood loss requiring transfusion of ≥ 2 units~Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding~TIMI Minor Bleeding"|Through 30 days post-procedure||||events|||Number
1411712|NCT01168024|Primary|Incidence of Contrast Induced Nephropathy (CIN) in Subjects.|CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).|Through 72 hours post-procedure||||participants|||Number
1411713|NCT01167907|Secondary|Reduction of Quadriceps Strength|"Secondary endpoints of reduction of quadriceps strength will be evaluated. To determine the effect of saphenous block on quadriceps function, patients will have knee extension muscle strength using a Hoggan Health microFET 2 MT Digital Handheld Dynamometer.~Knee Extension: Measuring knee extension was performed with the digital dynamometer placed on the anterior surface of the lower leg proximal to the ankle."|24 hours post nerve blockade||||pounds||Standard Deviation|Mean
1411714|NCT01167907|Secondary|Sleep Disturbance|Secondary endpoints of reduction of sleep disturbance (as number of awakenings) will be evaluated.|48 hours post nerve blockade||||awakenings||Standard Deviation|Mean
1411715|NCT01167907|Secondary|Vomiting|Secondary endpoints of reduction of vomiting will be evaluated.|48 hour post nerve blockade||||Participants|||Count of Participants
1411716|NCT01167907|Secondary|Nausea|Secondary endpoints of reduction of nausea will be evaluated.|48 hours post nerve blockade||||Participants|||Count of Participants
1411717|NCT01167907|Secondary|Opioid Use|"Secondary endpoints of reduction of opioid use will be evaluated.~Outcome will be measured using 24h mg-equivalent oxycodone consumption. - (Units in mg/24h)"|48 hours post nerve blockade||||mg per 24h||Standard Deviation|Mean
1411718|NCT01167907|Primary|Verbal Pain Scores|"The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved.~“Verbal Pain Score” is the outcome measure applied by asking patients to rate their level of pain. The commonly used 11-point numerical pain rating, with 0-10 range is defined as the following: Zero (0) is used to rate “no pain” and is the best score Ten (10) is used to rate “the worst pain imaginable” and is the worst score"|48 hours post nerve blockade||||units on a scale||Standard Deviation|Mean
1411719|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mmHg||Standard Error|Mean
1411720|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mmHg||Standard Error|Mean
1411721|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.||baseline and 52 weeks|Treated set, all patients treated with at least one dose of randomised study drug.|||participants|||Number
1411722|NCT01167881|Secondary|The Change in Body Weight From Baseline After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||kilograms||Standard Error|Mean
1411723|NCT01167881|Secondary|The Change From Baseline in HbA1c After 52 Weeks of Treatment.||baseline and 52 weeks|FAS (LOCF) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
1411724|NCT01167881|Secondary|The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mmHg||Standard Error|Mean
1411725|NCT01167881|Secondary|The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.||baseline and 104 weeks|FAS (LOCF-H) – Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||mmHg||Standard Error|Mean
1411726|NCT01167881|Secondary|The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.||baseline and 104 weeks|Treated set, all patients treated with at least one dose of randomised study drug.|||participants|||Number
1411739|NCT01167712|Other Pre-specified|Changes in the Tumor Perfusion Parameters as Quantified by Vascularity or Blood Volume; Perfusion or Blood Flow; Mean Transit Time; and Microvascular Permeability or Permeability Surface Area Product||Baseline (T0) up to 10 days after the start of course 2 (T2)|||||||
1411740|NCT01167712|Secondary|Quality of Life Score as Measured by Functional Assessment of Cancer Therapy-Ovary-Total Outcome Index (Fact-O TOI)|Mean quality of life score after 6 cycles of study treatment estimated from a mixed model. The FACT-O-TOI is composed of three subscales: Physical Well Being (PWB) (7 Items), Functional Well Being (FWB) (7 items), and Ovarian Cancer Subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). A subscale score is computed as long as more than 50% of subscale items have been answered. A Total score of the FACT-O TOI is the summation of the three subscale scores; if more than 80% of the FACT-O TOI items provide valid responses and all three subscales have valid scores. A score of the FACT-O TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL)|18 weeks after enrolling on the study, which is the time it takes to complete 6 cycles of treatment plus 3 weeks|All individuals who did not opt for neo-adjuvant treatment and completed a baseline FACT-O TOI assessment and at least one follow-up assessment.|||Units on a Scale||Standard Error|Mean
1411741|NCT01167712|Secondary|Median Duration of First Quartile Survival|First Quartile Overall Survival|The timeframe is from enrollment onto the study up to 3 years after enrollment|Whole sample|||months||95% Confidence Interval|Median
1411742|NCT01167712|Primary|Progression-Free Survival|First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. Progression is defined using response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The timeframe is from enrollment onto the study up to 3 years following enrollment.|Whole sample|||months||95% Confidence Interval|Median
1411743|NCT01167634|Primary|Change in Weight|Change in weight between baseline and 24 weeks|24 Weeks||||pounds||Standard Deviation|Mean
1411744|NCT01167608|Primary|"3rd Most Commonly Reported Future Barrier to Mental Health Services: Services Are Not Available in my Community"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime||||percentage of total respondents|||Number
1411745|NCT01167608|Primary|"2nd Most Commonly Reported Future Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most commonly reported future barrier to mental health services reported by those who responded to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime||||percentage of total respondents|||Number
1411746|NCT01167608|Primary|"Most Commonly Reported Future Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common future barrier to mental health service reported by respondents to the survey described in the Methods section. Outcome is reported as the percentage of all respondents surveyed who endorsed this particular future barrier. This barrier can best be described as limited access.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime||||percentage of total respondents|||Number
1411747|NCT01167608|Primary|"3rd Most Commonly Reported Past Barrier to Mental Health Services: Out of Pocket Cost Was Too High"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 3rd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited access.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime||||percentage of total respondents|||Number
1411748|NCT01167608|Primary|"2nd Most Commonly Reported Past Barrier to Mental Health Services: Doctors Are Not Sensitive Enough to PD-related Issues"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the 2nd most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as limited knowledge of PD amongst treatment providers.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime||||percentage of total respondents|||Number
1411749|NCT01167608|Primary|"Most Commonly Reported Past Barrier to Mental Health Services: Anyone in my Situation Would be Struggling"|"The purpose of this study was to assess the 3 most commonly reported past and future barriers to mental health services. This outcome represents the most common past barrier to mental health services reported by survey respondents. The outcome reported is the percentage of all respondents surveyed who endorsed this particular past barrier. This barrier can best be described as low mental health literacy.~NOTE: This is an anonymous, cross-sectional survey study. Not all participants responded to every item, so sample size varies between outcome measures."|Lifetime||||percentage of total respondents|||Number
1411750|NCT01167582|Primary|Red Blood Cell Transfusion|Differences in mean number of units of red blood cell transfusions between the two study arms.|In-hospital up to 30 days post randomization||||blood units||Standard Deviation|Mean
1413691|NCT01152359|Secondary|Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)||48 weeks|||||||
1411751|NCT01167582|Secondary|Composite Mortality and Morbidity|Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization and pneumonia.|30 days and 6 months|||||||
1411752|NCT01167582|Secondary|Pneumonia or Blood Stream Infection and Each Separately||30 days and 6 months|||||||
1411753|NCT01167582|Secondary|Deep Vein Thrombosis and Pulmonary Embolism||30 days and 6 months|||||||
1411754|NCT01167582|Secondary|Stent Thrombosis||30 days and 6 months|||||||
1411755|NCT01167582|Secondary|Congestive Heart Failure||30 days and 6 months|||||||
1411756|NCT01167582|Secondary|Stroke||30 days and 6 months|||||||
1411757|NCT01167582|Secondary|Unscheduled Hospital Admission|Unscheduled hospital admission at 30 days and 6 months for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection.|30 days and 6 months|||||||
1411758|NCT01167582|Secondary|Mortality From Cardiac Causes||30 days and 6 months|||||||
1411759|NCT01167582|Secondary|Individual Components of Composite Outcome|All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.|30 days and 6 months|||||||
1411760|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months.|6 months||||participants|||Number
1411761|NCT01167582|Secondary|Mortality or Myocardial Ischemia|Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days.|30 days||||participants|||Number
1411762|NCT01167582|Primary|Hemoglobin Concentration|Differences in the mean hemoglobin concentrations between the two study arms.|In-hospital up to 30 days post randomization||||g/dL||Standard Deviation|Mean
1411763|NCT01167582|Primary|Trial Feasibility|"the number of eligible study subjects and enrollment rates, overall and by center;~the adherence rates for the transfusion protocol, overall and by center;~the frequencies of proposed outcomes"|6 months|||||||
1411764|NCT01167504|Secondary|Defined Behaviour of Salivary Film Formation|"A secondary output is a well defined description of the film formation behaviour of normalsaliva in terms of thickness (nm), viscoelastic modulus (mN/m) and temporal behaviour. This will be used to develop model or artificial salivas saliva that forms films in the same way as real saliva ex vivo, that can be used to screen the effects of different compounds and ingredients, without having to collect fresh saliva from human volunteers. The measure is the rate of increase in film thickness (depth, nm) as a function of time, measured by adsorbing whole mouth saliva onto a solid silica surface and measuring the film thickness using Dual Polarisation Interferometry and Quartz Crystal Microbalance."|Within 4 hours of saliva collection.|Literature data and power calculations were used to calculate the number of individuals required to show a statistical significant effect of the presence of ingredients on the thickness of the salivary film.|||nm/cm2/min||Standard Deviation|Mean
1411765|NCT01167504|Primary|Impact of Ingredients on Thickness (Depth, nm) of Salivary Films Adsorbed Onto Solid Surfaces|The principal output is to determine how ingredients in food and oral hygiene products affect the way that saliva forms films on surfaces similar to those found inside the mouth. We will determine the main physical properties of the film such as thickness (nm), adsorbed mass (ng/cm^2), density (ng/cm^3) measured by adsorbing whole mouth saliva onto solid silica surfaces and measuring the above properties of the film using Dual Polarisation Interferometry and a Quartz Crystal Microbalance. The effect of ingredients from food and oral hygiene products on the above measured parameters will be determined.|Within 4 hours of saliva collection.|Based on published results of saliva pellicle thickness, power calculations showed that 12 individuals would provide sufficient statistical significance to determine the effect of added ingredients on salivary film thickness.|||nm||Standard Deviation|Mean
1411766|NCT01167452|Primary|Elimination Rate Constants for Sulfamethoxazole and Trimethoprim||24 hours||||hr-1||Full Range|Median
1411767|NCT01167426|Secondary|Patient Injection Experience Preference|"The Injection Experience Preference Questionnaire utilizes a 5-level preference scale where participants were asked to compare their injection experience during the first 2 weeks (glatiramer acetate 20 mg/1 mL) with the past 2 weeks (glatiramer acetate 20 mg/0.5 mL). Response options were: 1. strongly prefer first experience (first 2 weeks); 2. somewhat prefer first experience (first 2 weeks); 3. no preference; 4. somewhat prefer second experience (past 2 weeks); 5. strongly prefer second experience (past 2 weeks). Responses 1 and 2 were combined into a single category (prefers first experience) and responses 4 and 5 were combined into a single category (prefers second experience)."|Week 4|Analysis Population with available data.|||participants|||Number
1411768|NCT01167426|Primary|Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience|"The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from strongly disagree (score = 1) to strongly agree (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience."|Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).|The Analysis Population consisted of of all patients who received at least one dose of study medication and had satisfaction data at time points 2 and 6 weeks, 2 and 4 weeks, or 2, 4 and 6 weeks.|||units on a scale||Standard Deviation|Mean
1411769|NCT01167257|Secondary|Net Change of the Global Response Assessment (GRA)|Efficacy:(measured the net change of variables from baseline and 1 month) The Global response assessment (GRA) have seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved.|Baseline to 4 weeks after initial treatment||||participants|||Number
1412756|NCT01159054|Primary|Changes in FDG-PET/CT Dual Scan Score||6 months|Analysis of images for this outcome measure was not done given than only 2 subjects had completed the study at the time of the study early termination and closure (per funding source)||||||
1411770|NCT01167257|Secondary|Net Change of the Urgency Severity Score (USS) Within 3 Days|Efficacy:(measured the net change of variables from baseline and 1 month) Urgency severity score (USS) within 3 days. The USS have 1-point scale ranging from 0 to 4. The USS grades urgency per toilet void as none, mild, moderate or severe.|Baseline to 4 weeks after initial treatment||||participants|||Number
1411771|NCT01167257|Secondary|Net Change of the Postvoid Residual Volume (PVR)|Efficacy:(measured the net change of variables from baseline and 1 month) Postvoid residual volume (PVR) Change = Week 4 minus Baseline value|Baseline and 1 month after initial treatment||||mL||Inter-Quartile Range|Median
1411772|NCT01167257|Secondary|Net Change of the Maximum Flow Rate (Qmax)|Efficacy:(measured the net change of variables from baseline and 1 month) Maximum flow rate (Qmax) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||mL/s||Inter-Quartile Range|Median
1411773|NCT01167257|Secondary|Net Change of the Functional Bladder Capacity (FBC)|Efficacy:(measured the net change of variables from baseline and 1 month) Functional bladder capacity (FBC) Change = Week 4 minus Baseline value|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||mL||Inter-Quartile Range|Median
1411774|NCT01167257|Secondary|Net Change of the Overactive Bladder Symptom Score (OABSS)|"Efficacy:(measured the net change of variables from baseline to 1 month) Overactive bladder symptom score (OABSS) The OABSS is a 4-item questionnaire developed to evaluate OAB symptoms. The maximal scores are 2, 3, 5 and 5 for daytime frequency, nighttime frequency, urgency and urgency in continence, respectively.~The OABSS range = 0 to 15 ((asymptomatic to very symptomatic). Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment||||units on a scale||Inter-Quartile Range|Median
1411775|NCT01167257|Secondary|Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days|"Efficacy:~Mean change of the urgency urinary incontinence (UUI) per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||Frequency per 3 days||95% Confidence Interval|Median
1411776|NCT01167257|Secondary|Mean Change of the Urgency Episodes Per 3 Days|"Efficacy:~Mean change of the Urgency episodes per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||Frequency per 3 days||95% Confidence Interval|Median
1411777|NCT01167257|Primary|Mean Change of the Total Frequency Per 3 Days|"Efficacy:~Mean change of the total frequency per 3 days from baseline to 4 weeks after the treatment day based on the 3-day voiding diary.~Change = Week 4 minus Baseline value"|Baseline to 4 weeks after initial treatment|Control arm: subject number S025 was removed from analysis for not meeting the requirement for analysis, thus control arm 27 subjects|||Frequency per 3 days||95% Confidence Interval|Mean
1411778|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and the Correlation to Tumor Response||Up to 15 months from time of registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.||||||
1411779|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancer as Measured by the Genetic Similarity Between the Primary Tumor and the Tumor in Animals||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
1411780|NCT01167192|Secondary|Successful Development of Animal Models in Triple Negative Breast Cancers as Measured by the Ability of the Tumors to Metastasize to Other Organs||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
1411781|NCT01167192|Secondary|Successful Development of Animal Models for Triple Negative Breast Cancers as Measured by the Ability to Passage the Tumors in Mice||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
1411782|NCT01167192|Secondary|Successful Development of Animal Models of Triple Negative Breast Cancers as Measured by the Ability to Grow the Tumors in Mice.||At the time of IVAD placement and at the time of surgery|Participants did not have sufficient tissue for this outcome measure to be analyzed.||||||
1411783|NCT01167192|Secondary|Medical Toxicities as Measured by Number of Grade 3 or Higher Adverse Events||30 days post surgery (approximately 16-20 weeks after start of registration)||||adverse event|||Number
1411784|NCT01167192|Secondary|Overall Survival Rate||Median follow-up was 59.9 months|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These 2 patients are not included in this outcome measure.|||percentage of participants|||Number
1411785|NCT01167192|Secondary|Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow||Up to 15 months from registration|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.||||||
1411786|NCT01167192|Secondary|Number of Participants With Surgical Complications||30 days post surgery (approximately 16-20 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to surgery and 1 patient expired prior to surgery. These two patients are not included in this outcome measure.|||participant|||Number
1411787|NCT01167192|Secondary|Time to Disease Progression|Progression = at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, unequivocal progression of existing non-target lesions.|Up to 5 years from registration|There are 8 participants not included in this outcome measure and the reasons are as follows: (1) removed from study due to treatment related toxicity prior to surgery, (1) expired prior to surgery, and (6) did not have progressive disease.|||months||Full Range|Median
1413692|NCT01152359|Primary|Body Weight||48 weeks||||percentage of weight change||95% Confidence Interval|Mean
1411788|NCT01167192|Primary|Relationship Between Tumor Response and Deficiencies in DNA Repair Mechanisms||Prior to surgery (approximately 12-16 weeks from registration)|The physician who was to perform the correlative laboratory work for the study left the university prior to performing the correlative work for this study.||||||
1411789|NCT01167192|Primary|Response Rate as Measured by Number of Participants Who Achieved Complete Response (CR) or Partial Response (PR)|"Complete response (CR) = disappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor marker level.~Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|Prior to surgery (approximately 12-16 weeks from registration)|1 patient was removed from study due to treatment related toxicity prior to efficacy evaluation and 1 patient expired prior to efficacy evaluation. These two patients are not included in this outcome measure.|||Participants|||Count of Participants
1411790|NCT01167179|Primary|Psychosocial Adjustment to Illness-Scale|The adaptive psychosocial response of an individual to a significant life change was assessed using the Psychosocial Adjustment to Illness Scale –Self Report (PAIS-SR), a 46-item self-report measure that assesses changes in seven domains. A mean PAIS-SR T-score of 50 is the average score for each domain, meaning that patients with this score adjusted neither better nor worse than a mixed cancer reference group, whereas a score lower than 50 indicates better adjustment. The total scale range for the T score is 21-80. The PAIS-SR is well validated and has been used in previous studies of HNC patients.Here, we used the validated Dutch translation.|baseline, 6 mo, 12mo|ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted|||units on a scale||Standard Deviation|Mean
1411791|NCT01167179|Secondary|Quality of Life|Quality of Life(QoL)was measured with the EORTC QLQ-C30 and QLQ-H&N35.The EORTC QLQ-C30 contains five functioning scales, a global health status/QoL scale, and nine symptom scales. The QLQ-H&N35 contains 18 disease-specific symptom scales. All scores in both the EORTC QLQ-C30 and QLQ-H&N35 were transformed to a 0-100 scale following instructions in the scoring manual, with higher scores representing better quality of life and less disease-specific symptoms.|baseline, 6 mo, 12 mo|ITT analyses. Linear mixed model for repeated measurements.Intervention an time (as well as their interaction), and adjustment factors tumor location, size of the tumor,treatment modality, living without a partner, and education (high vs. other) were included in the model as fixed effects. An unstructured covariance matrix was fitted|||units on a scale||Standard Deviation|Mean
1411792|NCT01167153|Secondary|Change From Baseline in Orthostatic Pulse at 12 Weeks|Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic pulse rate after baseline.|||beats/min||Standard Deviation|Mean
1411793|NCT01167153|Secondary|Change From Baseline in Sitting Pulse at 12 Weeks|Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of sitting pulse rate after baseline.|||beats/min||Standard Deviation|Mean
1411794|NCT01167153|Secondary|Change From Baseline in Orthostatic SBP and DBP at 12 Weeks|The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of orthostatic SBP and DBP after baseline.|||mm Hg||Standard Deviation|Mean
1411795|NCT01167153|Secondary|Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks|Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks.|12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of blood pressure control after baseline|||Percentage of participants|||Number
1411796|NCT01167153|Secondary|Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)|"Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.~Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline."|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of effective BP control after baseline.|||Percentage of participants|||Number
1411797|NCT01167153|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline.|||mm Hg||Standard Deviation|Mean
1411798|NCT01167153|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)|The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.|Baseline, 12 weeks|ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline.|||mm Hg||Standard Deviation|Mean
1411799|NCT01167140|Secondary|Participants With an Improvement in Global Appearance|• Subjects’ global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline|Up to 4 months|5 subjects were excluded from effectiveness analysis because they received a lower dose.|||participants|||Number
1411800|NCT01167140|Secondary|Participants With One Point Improvement in Line Severity|• Investigators’ rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline|Baseline and up to 4 months|Of the 41 subjects treated, 5 were treated at a lower dose and excluded from the effectiveness measure.|||participants|||Number
1411801|NCT01167140|Primary|Number of Participants With Effectiveness and Safety Success|"Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale~Safety success: the absence of a device-related serious adverse event (DSAE)"|Up to 4 months|All subjects treated were analyzed to the safety endpoint.|||participants|||Number
1411802|NCT01167023|Secondary|P2Y12 Reaction Units (PRU) as Measured by Accumetrics VerifyNow® P2Y12 (VN P2Y12) at 30 Days|PRU represents the rate and extent of adenosine (ADP)-stimulated platelet aggregation. The VN P2Y12 assay is a point-of-care device that measures platelet aggregation with single-use, disposable cartridges. A low PRU reflects stronger inhibition of P2Y12, whereas a high PRU reflects weaker inhibition of P2Y12. The Least Squares Mean values were calculated from a mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRU measurements and a non-missing genotype.|||P2Y12 Reaction Units (PRU)||Standard Error|Least Squares Mean
1411803|NCT01167023|Secondary|Intensity of Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded intensity of pain due to SCD each day in daily pain diaries using a pain scale. A scale of 0 to 9 was used, with 0=no pain and 9=unbearable pain. A response range of 1 to 9 indicated participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. Pain intensity was the average of a participant's pain ratings. Average pain intensity=(Sum of all nonmissing pain intensity responses/number of daily pain diaries completed). Number of daily pain diaries completed is number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who had recorded the pain intensity in at least 1 daily pain diary.|||units on a scale||Standard Deviation|Mean
1411804|NCT01167023|Secondary|Platelet Reactivity Index (PRI) Measured by Vasodilator-Associated Stimulated Phosphoprotein (VASP) at 30 Days|PRI was calculated by VASP phosphorylation assay using flow cytometry. The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12. The Least Squares (LS) Mean values were calculated from a mixed-effects model repeated measures (MMRM) analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model.|30 days|All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received. The analysis was performed in the safety population who had both baseline and 30-day PRI measurements and a non-missing genotype.|||percentage of PRI||Standard Error|Least Squares Mean
1411805|NCT01167023|Secondary|Percentage of Participants With Pain Events Related to Sickle Cell Disease (SCD) Requiring Medical Attention During the Treatment Duration|Pain requiring medical attention was defined 2 ways: (1) if the participant attended an unplanned doctor’s appointment or clinic visit, visited the emergency room, or was admitted to hospital due to sickle cell pain, or (2) if the participant experienced a vaso-occlusive crisis (VOC), acute chest syndrome, or hepatic sequestration at least once during the treatment period.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who completed at least 1 page of the daily pain diary or with pain endpoint case report form (CRF) data available.|||percentage of participants|||Number
1411806|NCT01167023|Secondary|Percentage of Days With Pain Related to Sickle Cell Disease (SCD) During the Treatment Duration|Participants recorded the intensity of pain due to SCD each day in the daily pain diaries. A scale of 0 to 9 was used, with 0 indicating no pain, and 9 indicating unbearable pain. A response range of 1 to 9 indicated the participant experienced pain due to SCD, whereas a response of 0 indicated participant did not experience pain due to SCD. The percentage of days with pain (pain rate) was calculated as follows: Pain rate = 100*(Total number of days with pain/number of daily pain diaries completed). Number of daily pain diaries completed was number of nonmissing pain intensity responses.|Baseline through 30 days|Intent to treat (ITT) population consisted of all randomized participants. Participants were analyzed according to the treatment they were randomized to. The analysis was performed in the ITT population who recorded pain intensity in at least 1 daily pain diary.|||percentage of days||Standard Deviation|Mean
1411807|NCT01167023|Secondary|Percentage of Participants With Hemorrhagic Treatment-Emergent Adverse Events (TEAEs) During the Treatment Duration|TEAEs were defined as AEs that occurred or worsened after receiving the study drug.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.|||percentage of participants|||Number
1411808|NCT01167023|Primary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention During the Treatment Duration|A hemorrhagic event requiring medical intervention. Medical intervention was defined as any medical attention resulting in therapy or further investigation during the 30-day treatment duration.|Baseline through 30 days|Safety population: All randomized participants who took at least 1 dose of study medication. Participants were analyzed according to the treatment they actually received.|||percentage of participants|||Number
1411809|NCT01166997|Primary|Major Bleeding and Intracranial Bleeding at 30 Days.|Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.|30 days||||participants|||Number
1411811|NCT01166971|Primary|Defocus Curve|A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”.|3 months after surgery|In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure.|||LogMAR||Standard Deviation|Mean
1411812|NCT01166958|Secondary|Average Bone Mineral Density of the One-third Radius at Baseline, 3 Months and 6 Months|One-third radius BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.||||g/cm2||Full Range|Mean
1411813|NCT01166958|Secondary|Average Bone Mineral Density of the Proximal Femur (Hip) at Baseline, 3 Months and 6 Months|Hip BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.||||g/cm2||Full Range|Mean
1411814|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum P1NP)|Serum P1NP was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.||||mcg/L||Full Range|Mean
1411815|NCT01166958|Secondary|Average Bone Mineral Density of the Spine at Baseline, 3 Months and 6 Months|Spine BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.|BMD measured at the baseline, 3 month, and 6 month visits.||||g/cm2||Full Range|Mean
1411816|NCT01166958|Primary|Serum Markers of Skeletal Turnover (Serum CTX)|Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.|These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.||||ng/mL||Full Range|Mean
1411817|NCT01166763|Secondary|OH Vitamin D Levels in Serum|Assessment of 25(OH)D levels as a measure of circulating vitamin D.|baseline and 6 months|All subjects completing trial|||ng/ml||Standard Deviation|Mean
1411818|NCT01166763|Secondary|Change in Proliferation (as Assessed by Ki-67) Examined in Breast Epithelial Cells.|Change in percent of cells expressing staining for Ki-67 antibody in breast epithelial cell specimens acquird by Random Periareolar Fine Needle Aspiration.|baseline and 6 months|All subjects completing trial.|||percentage of cells staining positive||Full Range|Median
1411819|NCT01166763|Primary|Change in Mammographic Breast Density Over Course of Study|Change in the percent of the breast area that is considered to be at higher density on mammogram.|baseline and 6 months|All subjects completing trial|||Change in percent dense breast area||Standard Deviation|Mean
1411820|NCT01166750|Secondary|Quality of Life||weekly for 12 weeks|||||||
1411821|NCT01166750|Secondary|Mood and Stress||weekly for 12 weeks|||||||
1411822|NCT01166750|Primary|Pain|Pain intensity on a 0 to 10 visual analog scale with 0 being no pain and 10 being worst possible pain.|weekly for 12 weeks|They were the ones still remaining at the end of the study.|||units on a scale||Standard Deviation|Mean
1411823|NCT01166724|Secondary|Change in iGFR|We will also compare the change in iGFR (as well as estimated GFR) from time of conversion to 12 and 24 months of follow up by paired t-test between groups.|12 months|Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.||||||
1411824|NCT01166724|Primary|Biopsy-derived Measures of Fibrosis|The primary analyses will compare biopsy-derived measures of fibrosis in the Tac-maintenance and SRL groups using the t-test.|12 months|Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.||||||
1411825|NCT01166659|Secondary|Mean Number of Topical IOP-Lowering Medications Used in Comparison With Baseline|The number of unique glaucoma medications was recorded. The mean number of topical IOP-lowering medications was computed by dividing the total number of medications used (the numerator) by the total number of subjects who reported on medication use at the visit.|Baseline, Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.|||medications|eyes|Standard Deviation|Mean
1411826|NCT01166659|Secondary|Proportion of Eyes With Achievement of Target IOP With and Without Use of Ocular Hypotensive Medication|Target IOP was defined as ≥ 6 mmHg and ≤ 21 mmHg. Proportion of eyes is reported as a percentage.|Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.|||percentage of eyes|eyes||Number
1411827|NCT01166659|Primary|Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20% at 12 Months Postoperatively Who Were on Fewer or the Same Number of Ocular Hypotensive Medications as Compared With Baseline|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. Proportion of eyes is reported as a percentage.|Baseline; Month 12 postoperative|Eyes implanted with the CyPass 2FX device with data available.|||percentage of eyes|eyes||Number
1411828|NCT01166646|Secondary|"Number of Subjects Whose Signs of Psoriasis Was Designated Success"|Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) “success” and “failure” with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared [Day 8 or Day 15] or end of the assigned treatment period).|Day 15|"Analysis shown is based on the number of subjects whose Signs of Psoriasis was designated Success (ITT population) at Day 15."|||participants|||Number
1411829|NCT01166646|Secondary|Changes in Disease Severity (Success)|Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. ODS evaluations will be dichotomized to “success” and “failure” with success defined as a grade of 1 or 0 at the end of treatment (EOT).|Day 15|Analysis shown is based on the ITT population at Day 15.|||participants|||Number
1411830|NCT01166646|Primary|Pharmacokinetic Properties (AUC)|Comparison of PK results (area under the curve [AUC] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetics properties were evaluated in a subgroup of 12 adult subjects per arm.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1411831|NCT01166646|Primary|Pharmacokinetic Properties (Tmax)|Comparison of PK results (time to peak concentration [Tmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.|||Hours||Full Range|Geometric Mean
1411832|NCT01166646|Primary|Pharmacokinetic Properties (Cmax)|Comparison of PK results (peak concentration in plasma [Cmax]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.|Day 8|Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1411833|NCT01166646|Primary|Adrenal Suppression Potential|Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment.|After 1-2 weeks dose|Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||participants|||Number
1411834|NCT01166438|Secondary|Patient Global Impression of Improvement|The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better).|3 and 6 months||||Participants|||Count of Participants
1411835|NCT01166438|Secondary|Change in PFDI-SF and PFIQ-SF Total Scores|Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings.|Baseline through 6 months|Data were available for 111 participants in the Standardized Anticholinergic Regimen group and 102 in the Botox A group.|||Changes in adjusted mean scores||Standard Error|Mean
1411836|NCT01166438|Secondary|Efficacy|Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI).|6 months|Efficacy outcomes were assessed in the modified intention-to-treat population, which included all participants who underwent randomization and received a study medication and who had a baseline measure and at least one follow-up measure for the outcome. Proportions were based on data from participants who returned at least four follow-up diaries.|||Participants|||Count of Participants
1411837|NCT01166438|Secondary|Change From Baseline in Score on OABq-SF|Values for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group.|Baseline through 6 months||||Change from baseline in score on OABq-SF||Standard Error|Mean
1411838|NCT01166438|Primary|Change in Urge Urinary Incontinence (UUI) Episodes|Change from baseline in mean number of UUI episodes over 6 month double-blind period.|Baseline through 6 months||||Mean change in UUI episodes from baselin||Standard Error|Mean
1411839|NCT01166347|Secondary|Cause of Re-hospitalization|"Cause of Re-hospitalization while on device. The reason a participant may have been re-hospitalized was due to an adverse event, the need for an explant, or for various Other reasons."|Implant to two years|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received.|||Participants|||Count of Participants
1411840|NCT01166347|Secondary|Duration of Re-hospitalization|Duration of Re-hospitalization while on device|Implant to two years|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. Subjects who died while in the hospital or have a missing discharge date were not included.|||Days||Standard Deviation|Mean
1411841|NCT01166347|Secondary|Number of Participants Who Had a Re-hospitalization|Number of participants who had a re-hospitalization while on the device|Implant to two years|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received.|||Participants|||Count of Participants
1411842|NCT01166347|Secondary|Length of Initial Hospitalization|Length of Initial Hospitalization post implant|Implant to the end of the initial hospitalization|Only randomized subjects who successfully received an implant are included. Subjects are analyzed based on the device they actually received. Subjects who died while in the hospital or have a missing discharge date were not included.|||Days||Standard Deviation|Mean
1411843|NCT01166347|Secondary|Change in Functional Status as Measured by 6-minute Walk|Change in functional status, as measured by 6-minute walk test.|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete the assessment or indicate Not Completed to be analyzed at both the baseline and Month 24 visits. If the subject did not complete the assessment, a value of 0 was imputed.|||Meters||Standard Deviation|Mean
1411844|NCT01166347|Secondary|Change in Functional Status Measured by New York Heart Association (NYHA) Class|"Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA:~I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.~II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III)."|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.|||Participants|||Count of Participants
1423338|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Sodium|Change from baseline|Baseline and 52 week after||||mEq/L||Standard Deviation|Mean
1411845|NCT01166347|Secondary|Health Status Change Measured by EuroQol EQ-5D (Version 3L)|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). An adjustment was done on the response where the scores were normalized based on this paper: Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66.|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.|||units on a scale||Standard Deviation|Mean
1411846|NCT01166347|Secondary|Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.|Change from baseline to 2 years|Only randomized subjects who successfully received an implant are included. Subjects also had to reach the Month 24 visit and complete both the baseline and Month 24 assessments to be analyzed.|||Units on a scale||Standard Deviation|Mean
1411847|NCT01166347|Secondary|Number of Participants With Device Malfunctions|"Number of Participants with device malfunctions per INTERMACS definition. Device malfunction denotes a failure of one or more of the components of the Mechanical Circulatory Support Device (MCSD) system which either directly causes or could potentially induce a state of inadequate circulatory support (low cardiac output state) or death. The manufacturer must confirm device failure. A failure that was iatrogenic or recipient-induced will be classified as an Iatrogenic/Recipient-Induced Failure.~Device failure should be classified according to which components fails as follows:~Pump failure (blood contacting components of pump and any motor or other pump actuating mechanism that is housed with the blood contacting components).~Non-pump failure (e.g., external pneumatic drive unit, electric power supply unit, batteries, controller, interconnect cable, compliance chamber)"|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Participants|||Count of Participants
1411848|NCT01166347|Secondary|Overall Survival at 2 Years|Overall survival is the probability (expressed as a percent of 100) did not died within 2 years post implant via the Kaplan-Meier method. Participants that did not died were censored at the time of last follow-up or 2 years post implant, whichever occurred first.|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Probability|||Number
1411849|NCT01166347|Secondary|Number of Participants With Major Infections|Number of participants with major infections, per INTERMACS definition. A major infection is defined as: A clinical infection accompanied by pain, fever, drainage and/or leukocytosis that is treated by anti-microbial agents (non-prophylactic). A positive culture from the infected site or organ should be present unless strong clinical evidence indicates the need for treatment despite negative cultures. The general categories of infection include Localized non-device infection Percutaneous site and/or pocket infection Internal pump component, inflow or outflow tract infection Sepsis|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Participants|||Count of Participants
1411850|NCT01166347|Secondary|Number of Participants With Bleeding|"Number of participants with bleeding, per Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definition. The event of bleeding is defined as: An episode of suspected internal or external bleeding that results in one or more of the following:~Death,~Re-operation,~Hospitalization,~Transfusion of red blood cells as follows:~During first 7 days post implant~Adults (≥ 50 kg): ≥ 4U packed red blood cells (PRBC) within any 24 hour period during first 7 days post implant.~After 7 days post implant~Any transfusion of packed red blood cells (PRBC) after 7 days following implant."|Implant to two years|Only randomized subjects who successfully received an implant are included.|||Participants|||Count of Participants
1411851|NCT01166347|Primary|Stroke-Free Survival Probability for 2 Years Post Implant|The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale >=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percent of 100) are used.|Implant to 2 years|Only randomized subjects who successfully received an implant are included.|||Probabillity|||Number
1411852|NCT01166282|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either probably related to study drug, possibly related to study drug, probably not related, or not related to study drug.~For more details on adverse events please see the AE section below."|Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks)|Safety population: All randomized subjects who received at least 1 dose of study drug|||participants|||Number
1411903|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine (Ach) and sodium nitroprusside (NaNP).|12 Weeks post-randomization||||percent change over baseline||Inter-Quartile Range|Median
1411853|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)|The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used.|Baseline and Week 12|ITT population|||percentage of participants|||Number
1411854|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)|The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used.|Baseline and Week 12|ITT population|||percentage of participants|||Number
1411855|NCT01166282|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)|The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data.|Baseline and Week 12|ITT population|||percentage of participants|||Number
1411856|NCT01166282|Secondary|Swollen Joint Count (SJC68): Change From Baseline to Week 12|Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population|||units on a scale||Standard Deviation|Mean
1411857|NCT01166282|Secondary|Tender Joint Count (TJC72): Change From Baseline to Week 12|Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population|||units on a scale||Standard Deviation|Mean
1411858|NCT01166282|Secondary|Number of Sites of Enthesitis: Change From Baseline to Week 12|The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.|Baseline and Week 12|ITT population|||sites of enthesitis||Standard Deviation|Mean
1411859|NCT01166282|Primary|Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12|A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline and Week 12|ITT population|||percent change||Standard Deviation|Mean
1411860|NCT01166230|Secondary|Rate of Progression|"Only patients with Ta/T1 were included in the follow-up study. Progression is defined as presence of T2-T4 tumors, with or without carcinoma in situ (CIS), at worst recurrence."|4.5 years||||percentage of patients|||Number
1411861|NCT01166230|Primary|Recurrence Free Survival||up to 4.5 years|Intention-to-treat (ITT)|||months||95% Confidence Interval|Median
1411862|NCT01166230|Other Pre-specified|Median Time to Recurrence||up to 4.5 years|ITT|||months||95% Confidence Interval|Median
1411863|NCT01166230|Other Pre-specified|Longer-term Recurrence-free Rates After Hexvix (Cysview) and Non-Hexvix (Cysview) Cystoscopy/TURB|To extend the follow-up period of the pivotal trial (B305/04) to up in all available patients, to assess a longer-term estimate of recurrence-free rates after Hexvix and non-Hexvix cystoscopy/TURB, and to assess numbers and types of recurrences, amount and type of treatment given, and numbers of deaths.|up to 5.5 years retrospectively|ITT|||percentage of paticipants|||Number
1411864|NCT01166178|Secondary|Adverse Events and Serious Adverse Events Comparison of Treatment Groups|Adverse Events and Serious Adverse events are reported in the safety section.|24 months|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. The sample size was not powered for comparison between groups; however, all AEs are reported in the safety section.||||||
1411865|NCT01166178|Secondary|Course of Disease in Multiple Sclerosis Patients|The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist.|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1413693|NCT01152307|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs|2 weeks, on average|||||||
1411866|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 24 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411867|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip Region at 24 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411868|NCT01166178|Primary|Change in Bone Mineral Density of the Total Hip Region at 12 Months|"Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411869|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 24 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 24|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411870|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 12 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411871|NCT01166178|Secondary|Change in Bone Mineral Density of the Total Hip at 6 Months|Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone.|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411872|NCT01166178|Secondary|Change in Bone Mineral Density of the Femoral Neck at 6 Months|"Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411873|NCT01166178|Secondary|Change in Bone Mineral Density of the Lumbar Spine at 6 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 6|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411874|NCT01166178|Primary|Change in Bone Mineral Density of the Lumbar Spine at 12 Months|"Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12.~A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone."|Screening (day -21 to -1) and month 12|A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done.||||||
1411875|NCT01166139|Secondary|Efficacy of Nilotinib in Patients With Systemic Sclerosis, as Defined by an Improvement in the Modified Rodnan Skin Score|"Improvement in Modified Rodnan skin score reported as a mean (units equals number of points).~The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. In each of these areas, the skin score is evaluated by manual palpation. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas. The minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease."|12 months treatment||||units on a scale|||Number
1411876|NCT01166139|Secondary|Improvement of Modified Rodnan Skin Score Reported as a Mean (Units Equals Number of Points)|Efficacy of Nilotinib in patients with systemic sclerosis, as defined by an improvement in the Modified Rodnan Skin Score (MRSS) The Modified Rodnan Skin Score (MRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease.|6 Months of treatment||||units on a scale|||Number
1411877|NCT01166139|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||6 Months and 12 months treatment||||Adverse Events|||Number
1411878|NCT01166126|Secondary|Number of Participants With Related Serious Adverse Events (SAEs)|Toxicities assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.|1 year||||participants|||Number
1411879|NCT01166126|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months.|"Patients will be evaluated by physical examination and imaging assessments (brain MRI and CT scans of the chest, abdomen and pelvis). Disease progression will be defined by RECIST criteria on physical exam or diagnostic imaging assessments that are attributed to metastatic melanoma.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|6 months from day 1 of treatment||||participants|||Number
1411880|NCT01166126|Primary|Number of Participants With Overall Survival (OS) at One Year|The one-year overall survival of the combination of temsirolimus and AZD6244 Hydrogen Sulfate.|1 year post last treatment||||participants|||Number
1411881|NCT01166126|Primary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Anti-tumor response (CR+PR) was defined by Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|1 year|All participants|||participants|||Number
1411882|NCT01165996|Secondary|Proportion of Patients With Particular Genetic Abnormalities Detected by Whole Exome Sequencing Correlation With Clinical Response|Proportion of patients with particular genetic abnormalities detected by whole exome sequencing correlation with clinical response|Baseline||2013-03-31|03/2013||||
1411883|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Terminal Differentiation Response to Therapy.|Bone marrow evidence of terminal differentiation will be correlated with response criteria|Day 0,42,84||2013-03-31|03/2013||||
1411884|NCT01165996|Secondary|Proportion of Patients With Bone Marrow Evidence of Cytotoxicity.|Cytotoxicity will be correlated with clinical response criteria|Day 0, 42, 84||2013-03-31|03/2013||||
1411885|NCT01165996|Secondary|Proportion of Patients With Pharmacodynamic Evidence of Drug Effect.|Evidence of pharmacodynamic effect will be correlated with clinical response criteria.|Day 0, 42, 84||2013-03-31|03/2013||||
1411886|NCT01165996|Secondary|Cytogenetic Response as Per IWG Criteria|Described as the number of patients with a major cytogenetic response (refers to disappearance of a cytogenetic abnormality) or a minor cytogenetic response (50% or more reduction of abnormal metaphases).|at 12 months|Patients that had cytogenetic abnormalities at baseline.|||participants|||Number
1411887|NCT01165996|Secondary|Number of Patients That Experience > Grade 2 Non-hematologic Toxicity by National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) v4 Criteria|Incidence of treatment-emergent adverse events (AEs) will be presented in tables that include causality, seriousness, severity/grade, and whether the AE resulted in death or discontinuation of treatment, Laboratory data will be summarized in tables that show changes from pre-treatment values and frequencies of abnormal values. Descriptive statistics will also be provided.|up to 12 months of treatment|All patients that received treatment.|||participants|||Number
1411888|NCT01165996|Primary|Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia|The criteria for complete remission (CR) and partial remission (PR) involve specific improvements in marrow and peripheral blood measurements obtained on 2 or more successive assessments. The response parameters in peripheral blood must be maintained for at least 8 weeks. Responses designated as CR include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L (11 g/dL) or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease classification category than prior to treatment.|Formal assessment at week 12 for study primary end-point (hematologic improvement).|All patients enrolled and that received any treatment.|||participants|||Number
1411889|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, TNFα, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
1411890|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, sCD-40L ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
1411891|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MDC ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
1411892|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, MCP-1 pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
1411893|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, IL-8, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
1411894|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, GM-CSF pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
1411895|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, G-CSF, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
1411896|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteopontin, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
1411897|NCT01165983|Secondary|Absolute Change in Inflammatory Cytokines and Growth Factors, Osteoprotegerin, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
1411898|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, E-Selectin, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
1411899|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, C-reactive Protein, μg/mL||12 Weeks post-randomization||||μg/mL||Inter-Quartile Range|Median
1411900|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, t-PAI, pg/mL||12 Weeks post-randomization||||pg/mL||Inter-Quartile Range|Median
1411901|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sVCAM-1, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
1411902|NCT01165983|Secondary|Absolute Change in Biochemical Markers of Endothelial Function, sICAM-1, ng/mL||12 Weeks post-randomization||||ng/mL||Inter-Quartile Range|Median
1411904|NCT01165983|Primary|Skin Blood Flow Before and After Iontophoresis With Acetylcholine and Sodium Nitroprusside|Laser doppler imaging is used to measure microcirculatory changes pre- and post-iontophoresis of acetylcholine and sodium nitroprusside.|Baseline||||percentage change over baseline||Inter-Quartile Range|Median
1411905|NCT01165983|Primary|Nitroglycerine Induced Vasodilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|12 Weeks post-randomization||||percent change||Inter-Quartile Range|Median
1411906|NCT01165983|Primary|Nitroglycerin Induced Dilation|Using ultrasound, images are taken pre- and post-vasodilation of the brachial artery induced with a 0.4mg tablet of NTG.|Baseline||||percent change||Standard Deviation|Mean
1411907|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|12 Weeks post-randomization|Number of subjects that completed the study|||percent change over baseline||Inter-Quartile Range|Median
1411908|NCT01165983|Primary|Flow Mediated Vasodilation|Using ultrasound, percent change in brachial artery diameter is measured in response to an increase in shear stress from a tightened blood pressure cuff, which causes endothelium-dependent dilatation.|Baseline||||percentage change over baseline||Standard Deviation|Mean
1411909|NCT01165840|Primary|Serum Clearance|Serum clearance of dapsone|72 hours||||L/h||Standard Deviation|Mean
1411910|NCT01165775|Secondary|Neonatal Hypoglycemia||birth to discharge|Neonates from birth to discharge. The maternal patients received betamethasone to minimize the complications of prematurity. Maternal blood glucose levels were monitored using the Dexcom Seven Plus Continuous Glucose Monitoring System.|||participants|||Number
1411911|NCT01165775|Primary|Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment|During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (>110;>144;>180)|24-48 hours post betamethasone treatment|Seventeen women were enrolled at the time of betamethasone administration and data were available for 15 patients.|||percentage time||Standard Deviation|Mean
1411912|NCT01165684|Secondary|Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes)|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment.|Week 0 to Week 32|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. 397 subjects contributed with data.|||Episodes /year of patient exposure|||Number
1411913|NCT01165684|Secondary|Body Mass Index (BMI) at Week 32|Estimated mean BMI after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.|||kg/m^2||Standard Error|Mean
1411914|NCT01165684|Secondary|Body Weight at Week 32|Estimated mean body weight after 32 Weeks of treatment|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 378 subjects contributed to the statistical analysis at Week 32.|||kg||Standard Error|Mean
1411915|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32|Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 352 subjects contributed to the statistical analysis at Week 32.|||mmol/L||Standard Deviation|Mean
1411916|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 343 subjects contributed to the data at Week 21.|||mmol/L||Standard Deviation|Mean
1411917|NCT01165684|Secondary|Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10|Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 326 subjects contributed to the data at Week 10.|||mmol/L||Standard Deviation|Mean
1411918|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 32|Estimated Mean FPG at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.|||mmol/L||Standard Error|Mean
1411919|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 21|Mean FPG at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the data at Week 21.|||mmol/L||Standard Deviation|Mean
1411920|NCT01165684|Secondary|Fasting Plasma Glucose (FPG) at Week 10|Mean FPG at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 368 subjects contributed to data at Week 10.|||mmol/L||Standard Deviation|Mean
1411921|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32|Proportion of subjects reaching HbA1c below 7.0% at Week 32|Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.|||percentage (%) of subjects|||Number
1411922|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21|Proportion of subjects reaching HbA1c below 7.0% at Week 21|Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.|||percentage (%) of subjects|||Number
1411923|NCT01165684|Secondary|Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10|Proportion of subjects reaching HbA1c below 7.0% at Week 10|Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.|||percentage (%) of subjects|||Number
1411924|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21|Estimated mean change from baseline in HbA1c after 21 Weeks of treatment|Week 0, Week 21|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 21.|||percentage of glycosylated haemoglobin||Standard Error|Mean
1411925|NCT01165684|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10|Estimated mean change from baseline in HbA1c after 10 Weeks of treatment|Week 0, Week 10|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 376 subjects contributed to the statistical analysis at Week 10.|||percentage of glycosylated haemoglobin||Standard Error|Mean
1411926|NCT01165684|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32|Estimated mean change from baseline in HbA1c after 32 Weeks of treatment|Week 0, Week 32|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 383 subjects contributed to the statistical analysis at Week 32.|||percentage of glycosylated haemoglobin||Standard Error|Mean
1411927|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.|Post flutemetamol administration.||||Percent of Specificity-Normal Reads||95% Confidence Interval|Number
1411928|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.|Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.|Post flutemetamol administration.||||Percent of Sensitivity-Abnormal Reads||95% Confidence Interval|Number
1411929|NCT01165554|Secondary|Blinded Visual Interpretation of Each Subject’s Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.|"A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader N) divided by the (Total number of normal participants).~Blinded visual interpretation of each subject’s Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images."|Post Flutemetamol administrations|The assessment was done post-mortum based on the estimates of the presence of amyloid plaque in the brain.|||Percentage of Specificity by Reader|||Number
1411930|NCT01165554|Primary|The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.|"A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader N) divided by the (Total number of abnormal participants).~Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β."|Post flutemetamol administration.|The assessments were post-mortum based on the estimates of the presence of amyloid plaque in the brain.|||Percentage of Sensitivity by Reader|||Number
1411931|NCT01165541|Primary|Number of Very Heavy Drinking Days Per Week|The number of “very heavy” drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week|14 Weeks|The Analysis Population only consists of participants that completed both phases of the study.|||days||Standard Deviation|Mean
1411932|NCT01165450|Secondary|Percent Reduction of Corneal Epithelial Defect at Day 28 ± 2 in the Study Eye|To compare, in each of the two patient populations, the percent reduction in epithelial defect size at Day 28 ± 2 compared to baseline, as measured by slit lamp examination with fluorescein staining. Epithelial defect size determined by pseudo-area, defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
1411933|NCT01165450|Secondary|Persistence of Complete Corneal Re-epithelialization in the Study Eye|To determine whether or not complete corneal re-epithelialization was persistent, as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye. The measurement will be made at Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
1411934|NCT01165450|Secondary|Change in the Rate of Re-epithelialization of the Study Eye|"To determine the change in the rate of re-epithelialization of the study eye from the screening run-in period to the treatment period, if applicable.~Time Frame: Screening period is defined as Day -7 to Day 0 ± 1. Treatment period is defined as Day 0 ± 1 through time of complete re-epithelialization. Time of complete re-epithelialization is defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2."|35 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
1411935|NCT01165450|Secondary|Complete Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|To determine binary indicator of whether or not healing has occurred at 14 ± 1 days, defined as the largest diameter of the epithelial defect being smaller than 0.5 mm as determined by slit lamp examination with fluorescein staining.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
1411936|NCT01165450|Secondary|Time to Complete Re-epithelialization of the Study Eye|Resolution of epithelial defect is defined as the largest diameter of the epithelial defect being less than 0.5 mm, as it is difficult to distinguish a smaller defect from the small amount of fluorescing staining seen in a healed defect. Time of complete re-epithelialization will be defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
1411937|NCT01165450|Primary|Incidence of Adverse Events Following Application of the Investigational Product in All Subjects|Primary safety measure: To determine incidence of adverse events by recording their occurrence at each study visit through Day 28 ± 2. Analysis of safety data will be performed prior to each dose-escalation. If greater than 2 serious adverse events are found that are causally related to the investigational product, the study will be halted.|28 ± 2 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
1411938|NCT01165450|Primary|Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye|Primary efficacy measure: To determine whether topical treatment of persistent epithelial defects with Nexagon preparations yields greater healing at Day 14 ± 1, compared to vehicle alone, in individuals having had diabetic vitrectomy. Healing will be determined by comparing pseudo-area (as measured by Investigator, or designated ophthalmologist) at baseline (taken just prior to the first treatment) and Day 14 ± 1. Pseudo-area is defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.|14 ± 1 days|The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.||||||
1411939|NCT01165424|Secondary|Change From Baseline in the Total Nasal Symptom Score|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.|Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)|All treated participants|||units on a scale||Standard Error|Mean
1411940|NCT01165424|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions||Baseline to Week 24|All treated participants|||participants|||Number
1411941|NCT01165320|Primary|Percentage of Participants With One or More Drug-Related Adverse Experiences|An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.|Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days|The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for safety outcomes.|||Percentage of Participants|||Number
1411942|NCT01165320|Primary|Percentage of Participants With an Overall Favorable Response to Therapy|Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.|Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days|"The full analysis set included all enrolled participants who received >=1 dose of study drug. No participants with esophageal candidiasis were identified for inclusion in the study and assessment for response to therapy. Participants whose overall response assessment was unable to judge were counted as having an unfavorable response."|||Percentage of Participants|||Number
1411943|NCT01165307|Secondary|Subject Satisfaction at 12 Months|Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||participants|||Number
1411944|NCT01165307|Secondary|Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)|The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||mm||Inter-Quartile Range|Median
1411945|NCT01165307|Secondary|Bleeding Pattern at 12 Months|"The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea normal pattern (none of the above patterns)."|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||participants|||Number
1411946|NCT01165307|Secondary|Indirect Medical Costs|Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||dollars||Standard Deviation|Mean
1411947|NCT01165307|Secondary|Direct Medical Costs|Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||dollars||Standard Deviation|Mean
1411948|NCT01165307|Secondary|Change in Ferritin From Baseline||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||ug/L||Inter-Quartile Range|Median
1411949|NCT01165307|Secondary|Ferritin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||ug/L||Inter-Quartile Range|Median
1411950|NCT01165307|Secondary|Change in Hemoglobin||baseline, 12 months|Only subjects who completed the 12 month visit were included in the analysis.|||g/dL||Inter-Quartile Range|Median
1411951|NCT01165307|Secondary|Hemoglobin at 12 Months||Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||g/dL||Inter-Quartile Range|Median
1412332|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
1411952|NCT01165307|Secondary|Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )|The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains).|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1411953|NCT01165307|Secondary|Quality of Life Score Using the Short Form-12 (SF-12) Health Survey|Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
1411954|NCT01165307|Primary|Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).|The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.|Measured at 12 months following initial treatment|Only subjects who completed the 12 month visit were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1411955|NCT01165281|Secondary|Number of Patients Who Discontinued Due to Lack of Efficacy|The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy.|4 weeks|Time to discontinuation due to lack of efficacy was not analyzed since there was only 1 patient in the per-protocol set (in the tapentadol group) who discontinued treatment due to lack of efficacy.|||Number of participants|||Number
1411956|NCT01165281|Secondary|Proportion of Patients Entering the Maintenance Period|Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period.|4 weeks|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Percentage of Participants|||Number
1411957|NCT01165281|Secondary|Proportion of Patients With Various Levels of Pain Improvement (Responders)|The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period.|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Percentage of Participants|||Number
1411958|NCT01165281|Secondary|Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.|||Milligrams||Standard Deviation|Mean
1411959|NCT01165281|Secondary|Frequency of Rescue Medication Use for the Double-blind Treatment Period|During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed.|4 weeks|This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations.|||Number of doses per day||Standard Deviation|Mean
1411960|NCT01165281|Secondary|Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories|The PGIC was rated by the patient and was based on the single question “Since the start of this treatment, my cancer-related pain overall is,” where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline, Endpoint of the 4-week Treatment Period|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Percentage of Participants|||Number
1411972|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Medically Attended Events (MAEs)|Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.|From Month 0 to Month 8 post-vaccination|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
1411961|NCT01165281|Primary|Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale|The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: “What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine.” The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration.|Baseline, Last 3 Days of Study Drug Administration (4 weeks)|Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn’t have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation).|||Scores on scale||Standard Deviation|Mean
1411962|NCT01165242|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 through Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1411963|NCT01165242|Secondary|Number of Subjects With New Onset of Chronic Illness(es) (NOCI)|NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.|From Month 0 through Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1411964|NCT01165242|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0-30) post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1411965|NCT01165242|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
1411966|NCT01165242|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
1411967|NCT01165242|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|Vaccine response was defined as: -for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.|One month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1411968|NCT01165242|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs).|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Titers||95% Confidence Interval|Geometric Mean
1411969|NCT01165242|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
1411970|NCT01165242|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value|The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.|Prior to (PRE) and one month after vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
1411971|NCT01165242|Primary|Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies|"Vaccine response was defined as:~for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination;~for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination."|One month after vaccination (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the study vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.|||Participants|||Count of Participants
1411973|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any pIMDs|Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
1411974|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Related and Fatal SAEs|Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA.|From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0)|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
1411975|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Unsolicited AEs in Subjects ≥ 70 YOA|Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after each vaccination|The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered.|||Participants|||Count of Participants
1411976|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Participants|||Count of Participants
1411977|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Participants|||Count of Participants
1411978|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe ‘Worst’ HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.|Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
1411979|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe ‘Worst’ HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.|The duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411980|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ|Occurrence of PHN during the entire study period in all subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411981|NCT01165229|Secondary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA|Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411982|NCT01165229|Secondary|Number of Subjects With Medically Attended Events (MAEs)|Occurrence and relationship to vaccination of medically attended visitsother than routine health care visits, from Month 0 to Month 8 in all subjects. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|From Month 0 to Month 8 post-vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
1411983|NCT01165229|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects|During the entire study period (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
1411984|NCT01165229|Secondary|Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
1411985|NCT01165229|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30 days (Days 0-29) after each vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Participants|||Count of Participants
1411986|NCT01165229|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period|||Participants|||Count of Participants
1411987|NCT01165229|Secondary|Number of Subjects With Solicited Local Symptoms|Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period|||Participants|||Count of Participants
1411988|NCT01165229|Secondary|Number of Days With Pain Medication Associated With HZ||During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
1411989|NCT01165229|Secondary|Number of Subjects Receiving Pain Medication Associated With HZ||During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411990|NCT01165229|Secondary|Number of Subjects With HZ Related Complications|Incidence of HZ complications during the study in subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411991|NCT01165229|Secondary|Number of Subjects With Confirmed HZ Episode Related Hospitalizations|Incidence of overall and HZ-related hospitalizations during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411992|NCT01165229|Secondary|Number of Subjects With Overall Mortality and HZ-related Mortality|Incidence of overall and HZ-related mortality during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1412347|NCT01163162|Secondary|Serum Creatinine|We expect serum creatinine to confirm the results of creatinine clearance.|1 Week||||mg/dl/day||95% Confidence Interval|Mean
1411993|NCT01165229|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations||During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411994|NCT01165229|Secondary|Number of Days With Severe ‘Worst’ HZ-associated Pain|Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
1411995|NCT01165229|Secondary|Number of Subjects With Post-herpetic Neuralgia (PHN)|PHN cases in the mTVc.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411996|NCT01165229|Primary|Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ|Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411997|NCT01165229|Primary|Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)|Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411998|NCT01165229|Primary|Number of Subjects With Any Episodes of Herpes Zoster (HZ)|Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Participants|||Count of Participants
1411999|NCT01165216|Secondary|Serum Half-life (T-HALF) of Ipilimumab|T-HALF was calculated as the ratio of ln(2) to elimination rate constant (K), where K was estimated as negative slope obtained by regression of the terminal log-linear portion of the serum concentration vs time profile following the ipilimumab dose on Day 1 of Cycle 3. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods, using a validated PK analysis program. Actual times were used for the analyses. T-HALF measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||Days||Standard Deviation|Mean
1412000|NCT01165216|Secondary|Time of Maximum Observed Serum Concentration (Tmax)|Tmax was recorded directly from experimental observations. Actual times were used for the analyses. Tmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||Hours||Full Range|Median
1412001|NCT01165216|Secondary|Area Under the Concentration Curve From Time 0 to Day 21 (in 1 Interval Dosing) (AUC[0-21d]) for Ipilimumab|The AUC(0-21d) was calculated using a mixture of log- and linear-trapezoidal summations. Using no weighting factor, the terminal log-liner phase of the concentration-time curve was determined by least-square linear regression of at least 3 data points. Individual patient pharmacokinetic (PK) parameter values were derived by noncompartmental methods using a validated PK analysis program. Actual times were used for the analyses. AUC(0-21d) measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
1412002|NCT01165216|Secondary|Trough Observed Serum Concentration (Cmin) of Ipilimumab|Cmin was recorded directly from experimental observations. Actual times were used for the analyses. Cmin measurements were performed during the 3rd cycle, at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 (Day 8), and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent; or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||ug/mL||Standard Deviation|Mean
1412095|NCT01164891|Secondary|Overall Survival|Overall survival was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until death (maximum 841 days)|The data was not collected, as planned, due to small number of participants enrolled in the study.||||||
1412003|NCT01165216|Secondary|Maximum Serum Concentration (Cmax) of Ipilimumab|Cmax was recorded directly from experimental observations. Actual times were used for the analyses. Cmax measurements were performed during the 3rd cycle; at predose and at 1.5, 4 , 24 (Day 2), 48 (Day 3), 168 hrs (Day 8),and 336 (Day 15) hours postdose; during the 4th and subsequent cycle, predose ipilimumab; and off-treatment until progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure.|During Cycle 3: predose and 1.5, 4, 24, 48, 168, and 336 hours postdose ipilimumab|Participants who received at least 1 dose of ipilimumab|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1412004|NCT01165216|Secondary|Number of Participants With Best Overall Response (BOR) of Partial Response (PR) or Stable Disease|Tumor response was determined for all participants with measurable lesions by radiologic responses as defined by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The BOR was the best response recorded from start of treatment until disease progression/recurrence. RECIST for target lesions: PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started. At minimum, tumor measurements were to be obtained at screening, every 6 weeks (±1 week) during the induction phase and every 12 weeks (±1 week) during the maintenance phase.|Day 1 of Cycle 3, Day 1 of Cycle 5, and Day 22 of Cycle 6|Participants who received at least 1 dose of study drug|||Participants|||Number
1412005|NCT01165216|Secondary|Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. AE incidence was assessed from Day 1 until Week 24 and every 12 weeks thereafter during the maintenance period, until discontinuation of study drug, due to progression of disease, toxicities requiring discontinuation, withdrawal of consent, or study closure, and at least every 4 weeks(±1 week) until all study drug-related toxicities had recovered to resolved, stabilized or returned to baseline or were deemed irreversible during the follow-up period).|Continuously from Day 1 to Week 24 and every12 weeks thereafter during maintenance until discontinuation of drug|Participants who received at least 1 dose of any study drug|||Participants|||Number
1412006|NCT01165216|Primary|Number of Participants Experiencing a Dose-limiting Toxicity (DLT)|A DLT was defined as study drug-related adverse event occurring during the first 2 cycles after ipilimumab administration in the induction phase and was any of the following: Grade 4 absolute neutrophil count (ANC) decreased (<500 cells/ mm^3) for 7 or more consecutive days; febrile Neutropenia (body temperature ≥38.5° C with ANC <1000 /mm^3) lasting >3 days; Grade 4 platelet count decreased (<25,000 cells/mm^3) or Grade 3 platelet count decreased requiring a platelet transfusion; Grade 3 or greater nausea, vomiting, diarrhea, despite the use of adequate/maximal medical intervention; Grade 3 or greater aspartate transaminase/alanine transaminase level and rash that has not resolved to Grade 2 or lower within 2 weeks after onset; or any Grade 3 or greater nonhematologic toxicity (except Grade 3 fatigue, Grade 3 asthenia, Grade 3 transient arthralgia/myalgia, or Grade 3 transient abnormal electrolyte levels).|Day 1 of Cycles 1 and 2 From Day 1 of Cycle 3 to Day 21 of Cycle 4|Participants who received at least 1 dose of ipilimumab|||Participants|||Number
1412007|NCT01165203|Secondary|HIV VL|HIV VL was tabulated by HIV status, for subjects with a number of available results greater than or equal to (≥) 40 copies/mL.|At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18|The analysis was performed on the Total Vaccinated cohort, which included only vaccinated subjects with at least one vaccine administration documented, who had available results of ≥ 40 copies/mL.|||HIV-RNA copies/mL||Standard Deviation|Mean
1412008|NCT01165203|Secondary|CD4 Count|CD4 count was tabulated by HIV status.|At Screening Visit (up to 21 days prior to Month 0), Months 1, 2, 3, 6, 7 and 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||CD4 T-cells/million T-cells||Standard Deviation|Mean
1412009|NCT01165203|Secondary|Number of Subjects With Any Herpes Zoster (HZ) Cases and Complications||From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412010|NCT01165203|Secondary|­Anti-VZV and Anti-gE Antibody Concentrations, by HIV Status|Antibody concentrations were as determined by ELISA and tabulated by HIV status. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||mIU/mL||95% Confidence Interval|Geometric Mean
1412011|NCT01165203|Secondary|­Anti-VZV and Anti-gE Antibody Concentrations|Antibody concentrations were as determined by ELISA and tabulated for the main study groups. Anti-VZV and anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||mIU/mL||95% Confidence Interval|Geometric Mean
1412012|NCT01165203|Secondary|­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells, by HIV Status|The analysis focused on CD4 T-cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated by HIV status.|At Months 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||CD4 T-cells/million T-cells||Standard Deviation|Mean
1412013|NCT01165203|Secondary|­Frequencies of Varicella-Zoster Virus (VZV)- and gE-specific CD4 T-cells|The analysis focused on CD4 T cells expressing at least 2 cytokines (among IFN-g, IL-2, TNF-a and/or CD40L as determined by ICS at Months 0, 1, 2, 3, 6, 7 and 18 and tabulated for the main study groups.|At Month 0, 1, 2, 3, 6, 7 and 18|The analysis was performed on the ATP cohorts for immunogenicity and for persistence, which included all evaluable subjects for whom data concerning immunogenicity measures were available at the considered time points (up to Month 7 for the ATP cohort for immunogenicity and at Month 18 for the ATP cohort for persistence).|||CD4 T-cells/million T-cells||Standard Deviation|Mean
1412014|NCT01165203|Primary|­Anti-gE Antibody (Ab) Concentrations|­Anti-gE antibody (Ab) concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrolment. Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).|At Month 7||||mIU/mL||95% Confidence Interval|Geometric Mean
1412015|NCT01165203|Primary|Frequency of gE-specific CD4 T-cells|The analysis focused on CD4 T-cells expressing at least 2 cytokines (among interferon-gamma (IFN-g) , interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-a) and/or CD40 ligand (CD40L)) as determined by in vitro intracellular cytokine staining (ICS) at Month 7 in ART and non-ART cohorts presenting high CD4 counts at enrollment.|At Month 7|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures were available at Month 7.|||CD4 T-cells/million T-cells||Standard Deviation|Mean
1412016|NCT01165203|Primary|Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count, by HIV Status|In this analysis, results were tabulated by HIV status.|From Month 1 to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412017|NCT01165203|Primary|Number of Subjects With Any AIDS-defining Condition, by HIV Status|In this analysis, results were tabulated by HIV status|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412018|NCT01165203|Primary|Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects, by HIV Status|In this analysis, results were tabulated by HIV status|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412019|NCT01165203|Primary|Number of Subjects With Any Pre-defined Changes in HIV Viral Load (VL) and CD4 T-cell Count|In this analysis, results were tabulated for the main study groups.|From Month 1 to Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412020|NCT01165203|Primary|Number of Subjects With Any AIDS-defining Condition|In this analysis, results were tabulated for the main study groups.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412021|NCT01165203|Primary|Number of Subjects With Any Significant Change in Antiretroviral Therapy (ART), Including Initiation of ART in ART-naïve Subjects|In this analysis, results were tabulated for the main study groups. Significant changes to ART appeared due to failure to control HIV viral load and due to failure to maintain high CD4 cells count.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412022|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.|At Month 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412023|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 6|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412024|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also staus unknown.|At Month 3|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412025|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 2|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412026|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Month 1|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412027|NCT01165203|Primary|Number of Subjects With Any Hematological and Biochemical Parameters Below, Within or Above Normal Laboratory Ranges|The assessed parameters were Alanine Aminotransferase, Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Basophils, Bilirubin Total, Bilirubin Conjugated / Direct, Creatinine, Eosinophils, Glucose, Bicarbonate, Haemoglobin, Potassium, Lymphocytes, Monocytes, Sodium, Neutrophils, Platelets and White Blood Cells. Tabulation was made by relation to the normal laboratory ranges: below, within or above, and also status unknown.|At Screening Visit (up to 21 days prior to Month 0)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412028|NCT01165203|Primary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412029|NCT01165203|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral/axillary temperature above (>) 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412030|NCT01165203|Primary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of their intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1412031|NCT01165203|Primary|Number of Subjects With Any Adverse Events (AEs) of Specific Interest|AEs of specific interest include new onset of autoimmune diseases (NOADs) and other immune mediated inflammatory disorders from administration of the first dose of vaccine/placebo.|From Month 0 until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412032|NCT01165203|Primary|Number of Subjects With Any Fatal SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From screening (up to 21 days prior to Month 0) until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412033|NCT01165203|Primary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From screening (up to 21 days prior to Month 0) until Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412034|NCT01165203|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 18|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1412035|NCT01165177|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Subjects|||Number
1412047|NCT01165177|Secondary|Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ|The analysis focused on subjects taking pain medication due to HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412036|NCT01165177|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after each vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Subjects|||Number
1412037|NCT01165177|Secondary|Number of Subjects With AEs With Any and Related Medically Attended Visit (MAEs)|Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.|From Month 0 to Month 8 post-vaccination|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Subjects|||Number
1412038|NCT01165177|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects|During the entire study period (3 to 5 year period following Day 0)|This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.|||Subjects|||Number
1412039|NCT01165177|Secondary|Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)||Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Subjects|||Number
1412040|NCT01165177|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the TVc – Diary Card, which was a subset of subjects from the TVc, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Subjects|||Number
1412041|NCT01165177|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the total vaccinated cohort – Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.|||Subjects|||Number
1412042|NCT01165177|Secondary|Number of Days of Pain Medication Associated With HZ|The analysis was performed in subjects with a confirmed HZ episode|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
1412043|NCT01165177|Secondary|Distribution of Pain Medication Associated With HZ|The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed participants with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412044|NCT01165177|Secondary|Number of Subjects With HZ Related Complications, by Complication Type|Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412045|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations|The analysis focused on confirmed HZ episode related hospitalizations and deaths.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412046|NCT01165177|Secondary|Number of Days With Severe ‘Worst’ HZ-associated Pain.|Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Days||Standard Deviation|Mean
1413853|NCT01150474|Secondary|Pain at Hour 12|"Pain at 12 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|12 hours after surgery.||||units on a scale||Standard Deviation|Mean
1412048|NCT01165177|Secondary|Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ|The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412049|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Hospitalizations|The analysis focused on confirmed HZ episode related hospitalizations.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412050|NCT01165177|Secondary|Number of Subjects With HZ Related Complications|The analysis focused on the incidence of HZ complications in subjects with confirmed HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412051|NCT01165177|Secondary|Number of Subjects With Confirmed HZ Episode Related Mortality|The analysis focused on the number of subjects who died due to HZ|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412052|NCT01165177|Secondary|Number of Subjects With a Reduction of Duration of Severe ‘Worst’ HZ-associated Pain|Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412053|NCT01165177|Secondary|Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)|The incidence of PHN was calculated using the modified total vaccinated chort.|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412054|NCT01165177|Primary|Number of Subjects With Confirmed Herpes Zoster (HZ) Cases|Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)|During the entire study period (3 to 5 year period following Day 0)|The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.|||Subjects|||Number
1412055|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Reason for Incorrect Inhaler Use and Who Required Additional Instruction the Indicated Number of Times at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed based on 3 steps: open the device, inhale the dose, and close the device. If the participants did not perform the maneuvers correctly, the step of the inhaler use that was performed incorrectly by the participants was recorded. The entire procedure was demonstrated once again. and the number of times that the participants required additional instruction (RAI) was recorded.|Baseline, Week 2, and Week 4|ITT Population. Only those participants who used the inhaler incorrectly at the specified time points were analyzed.|||participants|||Number
1412056|NCT01165138|Other Pre-specified|Number of Participants Who Used the Inhaler Correctly or Incorrectly at Baseline, Week 2, and Week 4|Participants were given a demonstration of correct inhaler use (using placebo inhalers), and the participants' competence to correctly use the demonstration inhaler was then assessed.|Baseline (BL), Week 2 (W2), and Week 4 (W4)|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1412057|NCT01165138|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare were recorded.|From Baseline up to Week 12/Early Withdrawal|ITT Population|||Number of visits||Standard Deviation|Mean
1412058|NCT01165138|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Responses at Week 4, Week 8, and Week 12/Early Withdrawal|At the end of Week 4, Week 8, and Week 12/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptom); much less often , somewhat less often , a little less often , the same , a little more often , somewhat more often , much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 8, and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1412348|NCT01163162|Secondary|Creatinine Clearance|The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.|1 Week||||ml/min||95% Confidence Interval|Mean
1412059|NCT01165138|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Score at Week 12|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12/Early Withdrawal minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|||Scores on a scale||Standard Error|Least Squares Mean
1412060|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1412061|NCT01165138|Other Pre-specified|Mean Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period (at Week 12) minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
1412062|NCT01165138|Other Pre-specified|Number of Participants With Bronchodilator Effect|Bronchodilator effect is defined as an increase of FEV1 (defined as the maximal amount of air that can be forcefully exhaled in one second) from Baseline of both 12% and 200 milliliters (mL) during 24 hours, which was evaluated using the serial FEV1 measurements at Baseline (Visit 3).|Baseline|ITT Population. Only the subset of participants performing serial measurements were analyzed.|||participants|||Number
1412063|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-4 Hours Post-dose at Baseline and Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean serial FEV1 over 0-4 hours was calculated using the serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 12 was performed. Only those participants available at the specified time points were analyzed.|||Liters||Standard Deviation|Mean
1412064|NCT01165138|Other Pre-specified|Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Baseline|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements were recorded. Baseline was the value obtained at Visit 3.|Baseline|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 was performed.|||Liters||Standard Deviation|Mean
1412065|NCT01165138|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1 at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 12 clinic visit. The highest of 3 technically acceptable measurements was recorded. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Week 12|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 12 was performed.|||Liters||Standard Error|Least Squares Mean
1412066|NCT01165138|Secondary|Serial FEV1 Over 0-1 Hour Post-dose at Randomization|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Randomization. Serial FEV1 measurements after 5, 15, and 30 minutes and 1 hour post-dose were assessed. At each time point, the highest of 3 technically acceptable measurements was recorded. The analysis was performed using a repeated measures model adjusted for baseline, region, sex, age, treatment group, and planned time points.|Randomization|ITT Population. Serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed|||Liters||Standard Error|Least Squares Mean
1412067|NCT01165138|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 12-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 12/Early Withdrawal|ITT Population|||participants|||Number
1412068|NCT01165138|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline."|Baseline and Week 12/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|||Score on a scale||Standard Error|Least Squares Mean
1412069|NCT01165138|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1412070|NCT01165138|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1412071|NCT01165138|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 12 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 30 minutes prior to dosing at Baseline and within 5 minutes prior to dosing at Week 12) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 12 FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline FEV1, region, sex, age, and treatment group.|Baseline and Week 12|ITT Population. Weighted mean serial FEV1 was calculated for the subset of participants for whom serial FEV1 was performed at Week 12.|||Liters||Standard Error|Least Squares Mean
1412072|NCT01165138|Primary|Mean Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 12|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1measurement taken at the clinic visit while still on-treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the Week 12 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, region, sex, age, and treatment group. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing m|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
1412073|NCT01165112|Secondary|Ability to Proceed to Peripheral Blood Stem Cell (PBSC) Collection Following Treatment (Impact of This Regimen on Stem Cell Reserve)||Up to 5 weeks after the last course||||Participants|||Count of Participants
1412074|NCT01165112|Secondary|Preliminary Assessment of the Efficacy of This Regimen|Response will be defined by standard NCI criteria (Cheson et al) for lymphoid malignancies.|Up to 5 weeks after the last course||||Participants|||Count of Participants
1412075|NCT01165112|Primary|Safety and Toxicity of This Regimen|Count of participants experiencing a dose limiting toxicity. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 will be used to classify and grade toxicities.|Up to 5 weeks after the last course||||Participants|||Count of Participants
1412085|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Fecal Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over 2 time intervals (0-24 + 24-48 hours, 48-72 + 72-96 hours) for measurement of 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, glucuronide) levels.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.|||percentage of total dose administered||Standard Deviation|Mean
1412076|NCT01165112|Primary|Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies|Defined as dose at which approximately =< 25% of patients experience a DLT. Following completed observation of final patient, two-parameter logistic model fit to data, generating dose-response curve based on observed toxicity rate at dose levels visited. Based on this fitted model, MTD is estimated to be dose that is associated with toxicity rate of 25%. If estimate of slope parameter for fitted curve is not positive and finite, geometric mean of dose level used for last cohort and dose level that would have been assigned to next cohort is taken as MTD.|Up to 5 weeks after the last course||||mg/m2 x 2|||Number
1412077|NCT01165047|Primary|Number of Participants With Side Effects and/or Adverse Events|A phone contact will be made to the subject 5 days after the trial to assess general health status and collect information on any reported side effects or adverse events.|5 days||||participants|||Number
1412078|NCT01165021|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Enrollment until the first date of objectively determined PD or death up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=3.|||months||95% Confidence Interval|Median
1412079|NCT01165021|Secondary|Overall Survival (OS)|OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.|Enrollment until the date of death from any cause up to 64 months|All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=8|||months||95% Confidence Interval|Median
1412080|NCT01165021|Secondary|Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0|Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.|||percentage of participants||95% Confidence Interval|Number
1412081|NCT01165021|Secondary|Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)]|pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100.|At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)|Participants who received at least 1 dose of preoperative chemotherapy and had surgical tumor tissue samples available.|||percentage of participants||95% Confidence Interval|Number
1412082|NCT01165021|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.|From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy|Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.|||percentage of participants||95% Confidence Interval|Number
1412083|NCT01164891|Primary|Percentage of Total Dose in 14C-labeled RO5185426 and 14C-labeled Metabolite in Pooled Urine Samples|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples). Data for parent drug (RO5185426) and metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.|||percentage of total dose administered||Standard Deviation|Mean
1412084|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Urine of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Urine samples were pooled over period of 96 hours (pool of 0-6 + 6-12 + 12-24 + 24-48 + 48-72 + 72-96 hour samples), Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (2 unknown metabolites, glucosylation, mono-hydroxy) are reported.|0 up to 96 hours post dose on Day 15|PK Analysis Population.|||percentage of total radioactivity||Standard Deviation|Mean
1413707|NCT01151852|Secondary|Safety and Tolerability of Imatinib|percentage of patients who experienced toxicity from study treatment to evaluate the safety and tolerability of imatinib re-challenge in this patient population|Up to 3years||||percentage of participants|||Number
1412086|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Feces of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Fecal samples were pooled over two time intervals for this analysis (0-24 + 24-48 hours, 48-72 + 72-96 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolites (glucosylation, mono-hydroxy, and glucuronide) are reported.|0-24 + 24-48 hours, 48-72 + 72-96 hours post dose on Day 15|PK Analysis Population.|||percentage of total radioactivity||Standard Deviation|Mean
1412087|NCT01164891|Primary|Plasma 14C-labeled RO5185426 and 14C-labeled Metabolite Levels|Collection of samples for radioactivity continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48 hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). The concentrations were measured in nanogram equivalent per gram which was calculated based on ratio of dosed radioactivity and the last dose of RO5185426. The concentration values represented the drug portion of the last dose. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.|||nanogram equivalent per gram||Standard Deviation|Mean
1412088|NCT01164891|Primary|Percentage of Total Integrated Radioactivity in Plasma of 14C-labeled RO5185426 and 14C-labeled Metabolite|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). Plasma samples were pooled over three time intervals for this analysis based on available radioactive counts (4 + 6 hours, 12 + 24 hours, and 36 + 48 hours). Radioactivity was measured in terms of region of interest by high performance liquid chromatography. The radiolabelled components in each chromatogram were evaluated to determine retention times and peak area values. Data for 14C-labeled RO5185426 and 14C-labeled metabolite (mono-hydroxy) are reported.|4+6 hours, 12 +24 hours, 36+48 hours post dose on Day 15|PK Analysis Population.|||percentage of total radioactivity||Standard Deviation|Mean
1412089|NCT01164891|Primary|14C-labeled RO5185426 Recovery: Percentage of Dose Excreted in Feces and Urine|Urinary and fecal samples were analyze for the percentage dose recovered as total radioactivity. The radioactivity was determined on a Packard liquid scintillation counter. Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|Urine:0 hour (pre dose),in quantitative fraction(0-6,6-12,12-24 hours) post dose on Day 15,during 24 hour interval thereafter;Feces:From Day 14 upto pre dose on Day 15,during 24 hour interval post dose until recovery criterion;(maximum:432 hours for both)|PK Analysis Population. One participant was excluded in the analysis because of contamination of urine sample with feces.|||percentage of dose recovered||Standard Deviation|Mean
1412090|NCT01164891|Primary|AUC Ratio of Blood:Plasma 14C-labeled RO5185426|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analysed = participants with measurable data for this outcome.|||ratio||Standard Deviation|Mean
1412091|NCT01164891|Primary|Half-life of 14C-labeled RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||hour||Standard Deviation|Mean
1412092|NCT01164891|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Sample (AUClast) of 14C-RO5185426 in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1mSv.|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||(micrograms equivalent/milliliter)*hour||Standard Deviation|Mean
1412093|NCT01164891|Primary|Time to Reach Cmax in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||hours||Full Range|Median
1412094|NCT01164891|Primary|Maximum Plasma Concentration of 14C-labeled RO5185426 (Cmax) in Both Blood and Plasma|Collection of samples continued until the recovery criterion was met (radioactivity recovered from urine and feces ≤ 1 % of the radioactivity in the administered dose between any two successive 48-hour interval assessments). 14C-labeled RO5185426 given was equivalent to ≤1 millisieverts (mSv).|0 hour (prior to evening dose) on Day 14; 0 hour (pre dose), 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 168, 216, 312 hours post dose on Day 15, and then every 96 hour until recovery criteria met (maximum: 432 hours)|PK Analysis Population. Number of participants analyzed = participants with measurable data for this outcome.|||micrograms equivalent per milliliter||Standard Deviation|Mean
1412675|NCT01160237|Secondary|Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years||At Days 0, 7 and 182|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1412096|NCT01164891|Secondary|Number of Participants With a Response by Confirmed Best Overall Response|Best overall response (according to Response Evaluation Criteria In Solid Tumors 1.1 criteria) was defined as best response recorded from start of treatment until disease progression which included complete response (CR) or partial response (PR) that had been confirmed by second tumor assessment no less than (<) 4 weeks after criteria for response were first met. Confirmed CR: disappearance of all target and non-target lesions; no new lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). Confirmed PR: at least 30% decrease in sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression: at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From Baseline then Day 1 of Cycle 3 thereafter, Day 1 of every other cycle (every 2 months) until disease progression, withdrawal from study or death (maximum 841 days)|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
1412097|NCT01164891|Primary|Plasma RO5185426 Trough Concentrations on Days 15,16, and 17||Pre-dose on Days 15, 16 and 17|Pharmacokinetic (PK) Analysis Population: participants from whom the level of radioactivity recovered from excreta (urine and feces) was ≤ 1% of the radioactivity in the administered dose between any two successive 48-hour interval assessments.|||micrograms per milliliter||Standard Deviation|Mean
1412098|NCT01164865|Primary|Likert Questionnaire Scores at 2 Weeks|The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.|2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1412099|NCT01164865|Primary|Change From Baseline in Ocular Comfort Rating at 2 Weeks|"Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described how your eyes feel right now."|Baseline (Day 0), 2 weeks|All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1412100|NCT01164722|Secondary|Incidence of Metachronous Lesions|Number of patients with one or more metachronous lesions|one year on study|Patents with any biopsy from randomization to one year|||Participants|||Count of Participants
1412101|NCT01164722|Secondary|Recurrence Rate at 1 Year||1 year on study|Patients who were treated with IRC, no data were collected on patients on the expectant management arm|||Percentage of lesions that recurred|||Number
1412102|NCT01164722|Secondary|Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year|Number of patients who had high grade anal intraepithelial neoplasia at one year.|1 year on study|Patients who had an evaluable biopsy within one year after randomization.|||Participants|||Count of Participants
1412103|NCT01164722|Secondary|Tolerability and Safety of Infrared Coagulator Ablation|Number of patients who experienced a serious adverse events|All study visits through year 2||||participants|||Number
1412104|NCT01164722|Primary|Complete Response Through 1 Year|No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.|1 year post treatment|All study participants who were randomized and attended the baseline visit.|||participants|||Number
1412105|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number ten. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 10||||a ratio of pixels||Standard Error|Mean
1412106|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising based on a ratio of pixels on post-operative day number seven. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker.|Post-operative day 7||||a ratio of pixels||Standard Error|Mean
1412107|NCT01164644|Primary|Assess Extent of Bruising|Primary outcome measure will be to measure the extent of bruising in based on a ratio of pixels on post-operative day number three. Every subject held a card in front of their face with a specific size marker. The square area of this marker was known and used to measure the number of pixels in this marker with Photoshop and compare it to the known area. Next the area of bruising was measured in number of pixels. Therefore for every photograph a standardized ratio of pixels was known because of the marker. The ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.|Post-operative day 3||||a ratio of pixels||Standard Error|Mean
1412108|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) <2.6|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412109|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) â‰¤3.2|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28-4(ESR) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412110|NCT01164579|Secondary|Percentage of Participants With DAS28-4 (ESR) Response (Good or Moderate Improvement)|DAS28-4(ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (mm/hour) and Participant's Global Assessment of Disease Activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412111|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score <2.6|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) <2.6 implied remission.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412112|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Score â‰¤3.2|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3(CRP) â‰¤3.2 implied low disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412113|NCT01164579|Secondary|Percentage of Participants With DAS28-3 (CRP) Response (Good or Moderate Improvement)|DAS28-3(CRP) was calculated from the swollen joint count and tender joint count using 28-joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412114|NCT01164579|Secondary|Change From Baseline in DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
1412115|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from swollen joint count and tender joint count using 28 joints count, ESR (millimeters per hour [mm/hour]) and Participant Global Assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to 9.4; higher score=more disease activity. DAS28-4 (ESR) â‰¤3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1412116|NCT01164579|Secondary|Change From Baseline in DAS28-3 (CRP)|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.|Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
1412117|NCT01164579|Secondary|Disease Activity Score Based on 28-Joint Count and CRP (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (â‰¤)3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<)2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, and 12|FAS; n=number of participants assess for the specified parameter at a given visit.|||score on a scale||Standard Deviation|Mean
1412118|NCT01164579|Secondary|Percentage of Participants With an ACR 70% Improvement (ACR70) Response|ACR70 response: â‰¥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of Disease Activity, 3) Participant's Assessment of Pain, 4) Participant's Assessment of Functional Disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412119|NCT01164579|Secondary|Percentage of Participants With an ACR 50% Improvement (ACR50) Response|ACR50 response: â‰¥ 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Participant's Assessment of disease activity, 3) Paricipant's Assessment of Pain, 4) Participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Months 1, 2, 3, 6, 9, and 12|FAS NRI; n=number of participants assess for the specified parameter at a given visit.|||percentage of participants|||Number
1412120|NCT01164579|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20) Response|ACR20 response: greater than or equal to (â‰¥)20% improvement in tender joint count; â‰¥20% improvement in swollen joint count; and â‰¥20% improvement in at least 3 of 5 remaining ACR core measures: Participant's Assessment of Pain; Participant's Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Months 1, 2, 3, 6, 9, and 12|FAS Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders. n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1412121|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in Erosion Score|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
1443816|NCT00905515|Primary|Optimal Dose/Blood Level of Prograf in Long-term Maintenance Kidney Transplant Patients||6 months, 1 year, 2 years, 3 years|||||||
1412122|NCT01164579|Secondary|Erosion Scores at Months 6 and 12|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
1412123|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in JSN Scores|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
1412124|NCT01164579|Secondary|Joint Space Narrowing (JSN) Scores at Months 6 and 12|JSN score (a component of the modified TSS) is a measure of change in joint health. JSN score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||score on a scale||Standard Error|Least Squares Mean
1412125|NCT01164579|Secondary|Change From Baseline to Months 6 and 12 in mTSS|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) + erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Error|Least Squares Mean
1412126|NCT01164579|Secondary|Modified Total Sharp Score (mTSS) at Months 6 and 12|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Months 6 and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||score on a scale||Standard Error|Least Squares Mean
1412127|NCT01164579|Secondary|Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions|Bone erosion assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Each site was scored in 1.0 increments from 0 (no damage) to 10 (severe damage), indicating erosion (each unit=10% bone loss) of original articular bone. OMERACT RAMRIS total erosion score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist is 250 (range 0-250). Increasing score=greater severity.|Months 1, 3, 6, and 12|Evaluable Set|||score on a scale||Standard Error|Least Squares Mean
1412128|NCT01164579|Secondary|Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP|Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0â€“3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1â€“33% of bone edematous; 2: 34â€“66% of bone edematous; 3: 67â€“100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.|Months 1, 3, and 12|Evaluable Set; n=number of participants assessed for the specified parameter at a given visit.|||score on a scale||Standard Error|Least Squares Mean
1412129|NCT01164579|Secondary|Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Months 1, 6, and 12|Evaluable Set|||score on a scale||Standard Error|Least Squares Mean
1412130|NCT01164579|Primary|Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema|Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.|Month 6|Evaluable Set|||score on a scale||Standard Error|Least Squares Mean
1412144|NCT01164475|Primary|Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
1412202|NCT01163851|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin|AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Standard Deviation|Geometric Mean
1412131|NCT01164579|Primary|Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.|Month 3|Evaluable Set: all randomized participants who received at least 1 dose of the randomized investigational drug and for whom a variable is nonmissing at both baseline and the specified timepoint.|||score on a scale||Standard Error|Least Squares Mean
1412132|NCT01164501|Other Pre-specified|Hypoglycaemic Events|Percentage of patients who experienced a hypoglycaemic event. A hypoglycaemic event was regarded as confirmed if it was documented as an adverse event with plasma glucose values <= 70 mg/dL (<=3.9mmol/L) measured or with a documentation that the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative action had been required.|From first drug administration until 7 days after last trial medication intake, up to 458 days|Treated set which included all patients treated with at least one dose of randomised trial medication.|||percentage of participants|||Number
1412133|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
1412134|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
1412135|NCT01164501|Primary|HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment|"Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment.~Note adjusted means are provided."|Baseline and 24 weeks|Full analysis set (FAS) which included all randomised patients, treated with at least one dose of trial medication, who had a baseline HbA1c value. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.|||percentage of HbA1c||Standard Error|Mean
1412136|NCT01164475|Secondary|Terminal Elimination Half-life (T1/2)|T1/2 is the time required for the plasma concentration to decrease to one half.|0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||hours||Standard Deviation|Mean
1412137|NCT01164475|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all patients who have signed informed consent and received at least one dose of study drug.|||hours||Full Range|Median
1412138|NCT01164475|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||ng/mL||Standard Deviation|Mean
1412139|NCT01164475|Secondary|Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor|Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.|Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||fold increase||Standard Deviation|Mean
1412140|NCT01164475|Secondary|Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||10^6 cells/kg||Full Range|Median
1412141|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.|||days||Full Range|Median
1412142|NCT01164475|Secondary|Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg||Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.|||days||Full Range|Median
1412143|NCT01164475|Secondary|Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >= 2*10^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||percentage of participants|||Number
1412145|NCT01164475|Primary|Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)|The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.|Day 5 up to Day 8|FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.|||percentage of participants|||Number
1412146|NCT01164137|Primary|Health Services Utilization 18 Months Following Hospital Discharge|Mean health services utilization 18 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|18 months||||Health Services Utilizations||Standard Error|Mean
1412147|NCT01164137|Primary|Health Services Utilization 12 Months Following Hospital Discharge|Mean health services utilization 12 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|12 months||||Health Services Utilizations||Standard Error|Mean
1412148|NCT01164137|Primary|Health Services Utilization 9 Months Following Hospital Discharge|Mean health services utilization 9 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|9 Months||||Health Services Utilizations||Standard Error|Mean
1412149|NCT01164137|Primary|Health Services Utilization 6 Months Following Hospital Discharge|Mean health services utilization 6 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|6 Months||||Health Services Utilizations||Standard Error|Mean
1412150|NCT01164137|Primary|Health Services Utilization 3 Months Following Hospital Discharge|Mean health services utilization 3 months following hospital discharge. The specific health services utilization was re-admission to hospital, admission to home care, admission to long-term care and visits to emergency departments.|3 Months||||Health Services Utilizations||Standard Error|Mean
1412151|NCT01164007|Secondary|Overall Survival (OS)|OS was defined as the time from Baseline visit to the time of death from any cause. OS was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||months||95% Confidence Interval|Median
1412152|NCT01164007|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||percentage of participants|||Number
1412153|NCT01164007|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from start of treatment to the time of treatment discontinuation as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTF was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||months||95% Confidence Interval|Median
1412154|NCT01164007|Secondary|Percentage of Participants Who Discontinued Treatment|The percentage of participants who discontinued treatment as a result of death, adverse event, disease progression, loss to follow-up, non-compliance, or consent withdrawal was reported. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s).|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||percentage of participants|||Number
1412155|NCT01164007|Secondary|Time to Progression (TTP) According to RECIST|Tumor assessments were performed using RECIST. TTP was defined as the time from Baseline visit to time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). TTP was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||months||95% Confidence Interval|Median
1412156|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). The percentage of participants who died or demonstrated disease progression was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|ITT Population|||percentage of participants|||Number
1412157|NCT01164007|Secondary|DOR With CR, PR, or SD According to RECIST|Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR, PR, or SD to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. DOR was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR, PR, or SD."|||months||95% Confidence Interval|Median
1412227|NCT01163617|Primary|Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector|Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied.|Phase A (Week 0 and Week 2)||||cm||Standard Deviation|Mean
1412228|NCT01163604|Secondary|Clinical Endpoints||at one year|||||||
1412158|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR, PR, or Stable Disease (SD) According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression, using smallest sum of LD on study as reference. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR, PR, or SD was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR, PR, or SD."|||percentage of participants|||Number
1412159|NCT01164007|Secondary|Duration of Response (DOR) With CR or PR According to RECIST|Tumor assessments were performed using RECIST. DOR was defined as the time from first assessment of CR or PR to the time of death or disease progression, whichever occurred first. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. DOR was estimated by Kaplan-Meier methodology and expressed in months.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR or PR."|||months||95% Confidence Interval|Median
1412160|NCT01164007|Secondary|Percentage of Participants With Death or Disease Progression Following a Previous Assessment of CR or PR According to RECIST|Tumor assessments were performed using RECIST. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum on study or the appearance of new lesion(s). CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. The percentage of participants who died or demonstrated disease progression among those with a previous assessment of CR or PR was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|"ITT Population. The Number of Participants Analyzed reflects the number of participants with a previous assessment of CR or PR."|||percentage of participants|||Number
1412161|NCT01164007|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor assessments were performed using RECIST. CR was defined as disappearance of all target and non-target lesions with normalization of tumor markers. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to sum of LD at Baseline. Both were to be confirmed at a follow-up visit at least 4 weeks from the initial assessment of CR or PR. The percentage of participants with a best overall response of CR or PR during the study was reported.|Baseline up to approximately 6 years (assessed at Baseline, every 12 weeks on treatment, thereafter every 3 months)|Intent-to-Treat (ITT) Population: All participants who signed the ICF, were assigned a study identifier, and received at least one dose of study medications.|||percentage of participants|||Number
1412162|NCT01163955|Primary|Posture Control of Head Position, Shoulder Position and Back Position|Forward Head Position (FHP), Rounded Shoulder Position (RSP), and Thoracic spine (T/s)-Lumbar spine (L/s) positions were scored. Subscale scores of 0-3 for each FHP, RSP, and T/s L/s position were obtained. Score 0 was a perfect posture score, Score 1 was 0-1 inches out of alignment. Score 2 was 1-2 inches out of alignment. Score 3 was 2-3 inches out of alignment. Subscale scores were combined for a total score with a minimum value of 0 and a maximum value of 9. 0 being a perfect posture score, 9 being the worst postural score.|5 minute||||scores on a scale||95% Confidence Interval|Mean
1412163|NCT01163916|Secondary|Duration of Treatment With Adalimumab|Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.|For the duration of the study (up to a maximum of 18.2 months).|Safety set.|||weeks||Full Range|Median
1412164|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment|Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.|Baseline and at each follow-up visit (up to a maximum of 18.2 months).|Safety set|||participants|||Number
1412165|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Duration of Disease|Duration of disease was defined as the time from diagnosis until study entry.|Baseline|Safety set|||months||Full Range|Median
1412166|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Disease Severity|Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.|Baseline|Safety set.|||participants|||Number
1412167|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Marital Status|Participants were asked to indicate their marital status at the Baseline visit.|Baseline||||participants|||Number
1412168|NCT01163916|Secondary|Percentage of Participants With Missed or Delayed Injections|Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.|For the duration of the study (up to a maximum of 18.2 months).|Safety set; the analysis only includes participants with non-missing data.|||percentage of participants|||Number
1412189|NCT01163851|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
1412169|NCT01163916|Secondary|Patient's Acceptability of Self-injections|"At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were convenient, inconvenient and unable to self-inject.~The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.~Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization."|Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.|The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.|||participants|||Number
1412170|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Residence Status|Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.|Baseline||||participants|||Number
1412171|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Occupation|Participants were asked to indicate their occupation at the Baseline visit.|Baseline||||participants|||Number
1412172|NCT01163916|Primary|Characteristics of Patients Prescribed Adalimumab: Education Level|Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.|Baseline||||participants|||Number
1412173|NCT01163851|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA)|Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies. Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412174|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters|Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade. Categories with at least 1 participant were reported.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412175|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. ECG parameters RR interval, PR interval, QRS complex, QT interval, [Bazett's Correction], QTcF interval [Fridericia's Correction] were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412176|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic adverse events. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412177|NCT01163851|Secondary|Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic AEs.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412178|NCT01163851|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412229|NCT01163604|Secondary|Various Adverse Effects||at one year|||||||
1412676|NCT01160237|Secondary|Potential Immune Mediated Diseases||During the whole study period (Day 0 - Day 182)|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1412179|NCT01163851|Secondary|Number of Participants With Treatment-Emergent Adverse Events by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. AEs were assessed for severity by CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412180|NCT01163851|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and non-serious adverse events.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412181|NCT01163851|Secondary|Number of Participants With Toxicity or Intolerable Dose Criteria|Toxicity criteria included any of the following: serious adverse event; increased liver transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]: increased to greater than [>] 5*upper limit of normal reference range [ULN]); increased bilirubin (in absence of ALT or AST elevations, common terminology criteria for adverse events [CTCAE] greater than or equal to [>=] Grade 2); pancreatitis, increased serum creatinine (CTCAE >= Grade 2); creatine kinase, hyperglycemia or hypoglycemia, diarrhea or enteritis or nausea (CTCAE >= Grade 3); decreased platelet count (less than [<] 100000 per microliter); prolongation of QT interval with Fridericia's Correction (QTcF) (QTcF >500 millisecond [msec] [CTCAE >= Grade 3] or increase from baseline of >=60 msec) and other considered appropriate by investigator. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.|Day 1 up to Day 64|Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.|||Participants|||Count of Participants
1412182|NCT01163851|Secondary|Duration of Low Density Lipoprotein (LDL) Lowering Effects|In this outcome measure duration of the lipid-lowering effects was reported. Lipid lowering was defined as decrease in LDL-C levels by greater than or equal to 15 percent.|Day 4 to Day 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.|||days||Full Range|Median
1412183|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
1412184|NCT01163851|Secondary|Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
1412185|NCT01163851|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
1412186|NCT01163851|Secondary|Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
1412187|NCT01163851|Secondary|Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
1412188|NCT01163851|Secondary|Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||percent change||Standard Deviation|Mean
1412190|NCT01163851|Secondary|Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
1412191|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
1412192|NCT01163851|Secondary|Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
1412193|NCT01163851|Secondary|Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
1412194|NCT01163851|Secondary|Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
1412195|NCT01163851|Secondary|Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
1412196|NCT01163851|Secondary|Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.|Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64|Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.|||milligram per deciliter||Standard Deviation|Mean
1412197|NCT01163851|Primary|Apparent Volume of Distribution (Vz/F) of Atorvastatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' is signifying those participants who were evaluable for this measure for each group respectively.|||liter||Standard Deviation|Geometric Mean
1412198|NCT01163851|Primary|Apparent Oral Clearance (CL/F) of Atorvastatin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||liter per hour||Standard Deviation|Geometric Mean
1412199|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of Atorvastatin|Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||hour||Standard Deviation|Mean
1412200|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram per milliliter||Standard Deviation|Geometric Mean
1412201|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1423339|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
1412203|NCT01163851|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||nanogram*hour per milliliter||Standard Deviation|Geometric Mean
1412204|NCT01163851|Primary|Volume of Distribution at Steady State (Vss) of PF-04950615|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||liter||Standard Deviation|Geometric Mean
1412205|NCT01163851|Primary|Systemic Clearance (CL) of PF-04950615|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||liter per hour||Standard Deviation|Geometric Mean
1412206|NCT01163851|Primary|Plasma Decay Half-Life (t1/2) of PF-04950615|Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.|0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.|||hour||Standard Deviation|Mean
1412207|NCT01163851|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram per milliliter||Standard Deviation|Geometric Mean
1412208|NCT01163851|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1412209|NCT01163851|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615||0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Standard Deviation|Geometric Mean
1412210|NCT01163760|Other Pre-specified|Comfort While Working on Computer|"Comfort throughout the day was evaluated via subjective question: Comfort while working on computer and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week-follow-up||||percentage of participants|||Number
1412211|NCT01163760|Secondary|Comfort Throughout the Whole Day|"Comfort throughout the day was evaluated via subjective question: Comfort throughout the whole day and is reported as an aggregate of Agree Strongly and Agree Somewhat."|1-week follow-up|Subjects analyzed were those enrolled, randomized, and completed the study.|||percentage of participants|||Number
1412212|NCT01163760|Primary|Lens Comfort|"Lens comfort was evaluated via the subjective question: How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided? (excellent/very good=5...very good=3...Poor=0)"|1-week follow-up|Subjects analyzed were those who were enrolled, randomized, and completed the study.|||units on a scale||Standard Deviation|Mean
1412213|NCT01163747|Secondary|Number of Participants With Adverse Events Through Week 8|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any AE that is fatal or is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|8 weeks|All participants who received at least one dose of study treatment were included in the safety evaluation.|||participants|||Number
1412214|NCT01163747|Secondary|Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 7F, 8, 9N, 12F, 14, 18C, 19F and 23F."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine. N indicates the number of participants with available data for each serotype. No imputation was performed.|||percentage of participants|||Number
1412215|NCT01163747|Secondary|Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination|Levels of anti-tetanus antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.|||IU/mL||Standard Deviation|Mean
1412216|NCT01163747|Secondary|Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination|Levels of anti-pneumococcal antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.|||mg/L||Standard Deviation|Mean
1412217|NCT01163747|Secondary|Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination|A positive response to the tetanus toxoid vaccination was defined as antibody levels ≥ 0.2 IU/mL for participants with Baseline tetanus antibody levels < 0.1 IU/mL, or a 4-fold increase in antibody levels compared with Baseline for participants with Baseline tetanus antibody levels ≥ 0.1 IU/mL.|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for tetanus toxoid vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the tetanus toxoid vaccine.|||percentage of participants||95% Confidence Interval|Number
1412218|NCT01163747|Secondary|Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.|||percentage of participants||95% Confidence Interval|Number
1412219|NCT01163747|Primary|Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes|"Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.~The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C."|Baseline (Week 3) and Week 8 (5 weeks post-vaccination)|Evaluable per protocol population for pneumococcal polysaccharide vaccine: participants who received at least one dose of study medication, had no major protocol violations, had both baseline (Week 3) and Week 8 assessments of response with evaluable titers to the pneumococcal vaccine.|||percentage of participants||95% Confidence Interval|Number
1412220|NCT01163721|Primary|Change From Baseline in Fasting Serum Glucose at Week 12|Serum glucose was measured following an overnight fast. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Full Analysis Set|||mg/dL||Standard Error|Least Squares Mean
1412221|NCT01163721|Primary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 12 Following a Standardized Meal|2-hour postprandial serum glucose was defined as the average of serum glucose measurement at 120 minutes and 125 minutes following a standardized meal. The LOCF method was used. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Error|Least Squares Mean
1412222|NCT01163721|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a blood test to measure blood sugar control over the prior 3-month period. The last observation carried forward (LOCF) method was used: the last observed post-baseline measurements prior to Week 12 carried forward for participants with no available Week 12 values. Participants were summarized according to the actual treatment received regardless of the allocated treatment.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percent of HbA1c in blood||Standard Error|Least Squares Mean
1412223|NCT01163656|Primary|Time to Tracheal Intubation|The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.|Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.||||seconds||95% Confidence Interval|Median
1412224|NCT01163617|Secondary|Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)||||seconds||90% Confidence Interval|Mean
1412225|NCT01163617|Secondary|Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)||||seconds||90% Confidence Interval|Mean
1412226|NCT01163617|Primary|Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds|"A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C)."|Phase B (Week 4)||||seconds||90% Confidence Interval|Mean
1412230|NCT01163604|Secondary|NIHSS, mRS|NIHSS and mRS are widely used stroke deficit assessment tools. Most clinical stroke-related trials require a baseline and outcome severity assessment. The baseline of mRS is rank 0, NIHSS 0; the severity of mRS is 6, NIHSS 42. AS many patients have one or more strokes before they perform stenting, this study selected NIHSS and mRS as the supplementary materials to estimate the stroke deficit of patients and to reflect the therapeutic effect and safety of stenting and argatroban therapy. These two scales are performed according to the guidance before and after stenting and argatroban therapy.|at one year|||||||
1412231|NCT01163604|Primary|Number of Participants With Occlusion and Restenosis at One Year|Stenosis detected by DSA(digital subtraction angiography),CTA(CT angiography)or MRA(MR angiography)was measured according to NASCET(North American Symptomatic Carotid Endarterectomy Trial)method.Concretely, NASCET stenosis is calculated from the ratio of the linear luminal diameter of the narrowest segment of the diseased portion of the artery to the diameter of the artery beyond any poststenotic dilatation: NASCET=(1-md/C)×100%|at one year||||participants|||Number
1412232|NCT01163474|Secondary|Feasibility||1 month|||||||
1412233|NCT01163474|Secondary|Acceptability|Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).|1 month||||units on a scale||Standard Deviation|Mean
1412234|NCT01163474|Primary|Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)|Using CVT software and desktop webcams on the VA private network, “Virtual” CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits. Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions. Accuracy was assessed by comparing the 2 reviewers’ CVT decisions to the FTF decision.|1 month||||percentage of agreement|||Number
1412235|NCT01163461|Primary|Speech Production|percent change in the number of untrained words spoken correctly|Baseline to one week post treatment termination and three months post treatment termination||||% change score of untrained real words||Standard Deviation|Mean
1412236|NCT01163318|Secondary|Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit|MHAQ was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatic diseases. Participants assessed their ability to do each task over the past 6 months using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0 represented no disability and 3 very severe, high-dependency disability. MHAQ score ≤ 0.5 was defined as clinical remission, signifying normal physical function. Data are presented as percentage of participants.|Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.|||Percentage of participants|||Number
1412237|NCT01163318|Secondary|Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit|DAS28-4ESR, a combined index that measured activity of rheumatoid arthritis, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); and (4) ESR. DAS28-4ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28-4ESR scores indicate improvement of disease. DAS28-4ESR score < 2.6 was defined as clinical remission of rheumatoid arthritis. Data are presented as percentage of participants.|Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3|Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.|||Percentage of participants|||Number
1412238|NCT01163318|Secondary|Incidence of Infections and Malignant Tumors|Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.|||Percentage of participants|||Number
1412239|NCT01163318|Primary|Incidence of Adverse Drug Reactions (ADRs)|An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.|From the initiation of adalimumab treatment, every 6 months up to 3 years.|Safety analysis set, defined as participants who did not violate protocol criteria.|||Percentage of participants|||Number
1412240|NCT01163292|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.|Week 0 to Week 52|All participants registered|||participants|||Number
1412241|NCT01163292|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Weeks 0, 26, and 52|All participants with post-baseline HAQ-DI data, using LOCF imputation method|||units on a scale||Standard Deviation|Mean
1412242|NCT01163292|Secondary|Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52|Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Week 0 to Week 52|All participants with post-baseline mTSS data, using LOCF imputation method|||units on a scale||Standard Deviation|Mean
1412243|NCT01163292|Secondary|Matrix Metalloprotease-3 (MMP-3)|MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)|Weeks 0, 26, and 52|All participants with post-baseline MMP-3 data, using LOCF imputation method|||units on a scale|||Number
1412244|NCT01163292|Primary|Disease Activity Score (DAS28)|The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Weeks 0, 26, and 52|All participants with post-baseline DAS28 data, using last-observation-carried forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1412245|NCT01163279|Secondary|DKEFS Trail Making- Condition 4: Number-letter Switching|DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Time in seconds||Standard Deviation|Mean
1412246|NCT01163279|Secondary|DKEFS Word Fluency|This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Number of words generated||Standard Deviation|Mean
1412247|NCT01163279|Secondary|DKEFS Tower Test- Achievement Score|This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
1412248|NCT01163279|Secondary|Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time|This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Time in seconds||Standard Deviation|Mean
1412249|NCT01163279|Secondary|Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||number of visits||Standard Deviation|Mean
1412250|NCT01163279|Secondary|Stanford Patient Education Research Center- Communication With Physicians Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
1412251|NCT01163279|Secondary|Stanford Patient Education Research Center- Physical Activity Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||hours of physical activity/week||Standard Deviation|Mean
1412252|NCT01163279|Secondary|Stanford Patient Education Research Center- Health Distress Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
1412253|NCT01163279|Secondary|Stanford Patient Education Research Center- General Health Subscale|Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||units on a scale||Standard Deviation|Mean
1412254|NCT01163279|Secondary|General Self Efficacy Scale (GSE)|GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy|Baseline, Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||Scores on scale||Standard Deviation|Mean
1412255|NCT01163279|Primary|Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)|COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.|Immediately post intervention (2 months) and 3 months later|Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).|||percentage of untrained goals improved|Total number of goals||Number
1412256|NCT01163266|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1412257|NCT01163266|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
1412258|NCT01163266|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~The HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1412259|NCT01163266|Secondary|Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness Scale (CGI-S) score-by-week as fixed effects.|Week 8|Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1412260|NCT01163266|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
1412261|NCT01163266|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1412262|NCT01163253|Secondary|Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU)|Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant’s interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1412263|NCT01163253|Secondary|Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS)|EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412264|NCT01163253|Secondary|Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores|EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412299|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||beats per minute||Standard Deviation|Mean
1412265|NCT01163253|Secondary|Number of Participants With Patient Global Assessment (PtGA) Response of “Clear” or “Almost Clear”|The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as “clear (score of 0)” or “almost clear (score of 1)” in PtGA at each specified visit were reported in this outcome measure.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||participants|||Number
1412266|NCT01163253|Secondary|36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores|The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412267|NCT01163253|Secondary|36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores|The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition.|Baseline, Month 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412268|NCT01163253|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48|The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.|Baseline, Month 1, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412269|NCT01163253|Secondary|Dermatology Life Quality Index (DLQI) Scores|The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life.|Baseline, Month 1, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412270|NCT01163253|Secondary|Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48|ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412271|NCT01163253|Secondary|Itch Severity Item (ISI) Scores|ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412677|NCT01160237|Secondary|Number of Subjects Reporting Serious Adverse Events||During the whole study period (Day 0 - Day 182)|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.|||subjects|||Number
1412272|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1412273|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1412274|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1412275|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412276|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412277|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412278|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Scaling|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412279|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Induration|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412280|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores: Erythema|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412281|NCT01163253|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412282|NCT01163253|Secondary|Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1412283|NCT01163253|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported.|Baseline, Month 1, 3, 6, 12, 24, 36, 48|FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1412300|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
1446874|NCT00877929|Secondary|SBP Control 130 at Eight Weeks|Mean seated SBP < 130 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
1412284|NCT01163253|Secondary|Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear'|The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported.|Month 1, 3, 6, 12, 24, 36, 48|Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, ‘number of participants analyzed’ signifies participants evaluable for this outcome measure and ‘n’ signifies participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
1412285|NCT01163253|Primary|Number of Participants With Malignancy Events|Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1412286|NCT01163253|Primary|Number of Participants With Adjudicated Cardiovascular Events|Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1412287|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
1412288|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
1412289|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
1412290|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
1412291|NCT01163253|Primary|Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||milliseconds (msec)||Standard Deviation|Mean
1412292|NCT01163253|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett’s Correction) and QTcF (Fridericia’s Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1412293|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
1412294|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
1412295|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
1412296|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
1412297|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
1412298|NCT01163253|Primary|Change From Baseline in Heart Rate at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
1412301|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
1412302|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
1412303|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
1412304|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
1412305|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
1412306|NCT01163253|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1412307|NCT01163253|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||participants|||Number
1412308|NCT01163253|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1412309|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
1412310|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||IU/L||Standard Deviation|Mean
1412311|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
1412312|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
1412313|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
1412314|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
1412315|NCT01163253|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||international unit per liter (IU/L)||Standard Deviation|Mean
1412316|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1412317|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1412318|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1412319|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1412320|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1412321|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
1412322|NCT01163253|Primary|Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1412323|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
1412324|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
1412325|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 24||Baseline, Month 24|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
1412326|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
1412327|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
1412328|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||1000 cells/mm^3||Standard Deviation|Mean
1412329|NCT01163253|Primary|Change From Baseline in Lymphocyte and Neutrophil Count at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||1000 cells/mm^3||Standard Deviation|Mean
1412330|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 48||Baseline, Month 48|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
1412331|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 36||Baseline, Month 36|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
1412333|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 12||Baseline, Month 12|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
1412334|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 6||Baseline, Month 6|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
1412335|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 3||Baseline, Month 3|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||g/dL||Standard Deviation|Mean
1412336|NCT01163253|Primary|Change From Baseline in Hemoglobin Level at Month 1||Baseline, Month 1|Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||gram per deciliter (g/dL)||Standard Deviation|Mean
1412337|NCT01163253|Primary|Number of Participants With Laboratory Abnormalities|Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN).|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘number of participants analyzed’ signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1412338|NCT01163253|Primary|Number of Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant’s usual function; b) moderate: AEs interfered to some extent with participant’s usual function; c) severe: AEs interfered significantly with participant’s usual function.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||adverse events|||Number
1412339|NCT01163253|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
1412340|NCT01163214|Secondary|Number of Subjects Who Experienced Neurological Changes Postoperatively|Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.|6 weeks postoperative|The number of participants analyzed in the nerve block arm varied because data were not available for all participants in all neurological categories. The sample size for the periarticular injection arm was 79 because neurological data were not collected on 2 participants.|||participants|||Number
1412341|NCT01163214|Secondary|Length of Stay in Hospital|Length of stay data were calculated from the medical record.|Approximately 2 days after surgery|The number of participants analyzed were different than the baseline values for the arms because data were not available for some participants.|||days||Standard Deviation|Mean
1412342|NCT01163214|Secondary|Straight-leg Raise|Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.|Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon|The number of participants analyzed varied at each category time point because either data points were missing for participants, or as the condition of the participants improved, they were discharged from the hospital. Number of participants per arm for each time point is shown in each category label.|||participants|||Number
1412343|NCT01163214|Secondary|Narcotic Use|Use of additional narcotic medications (as needed), measured in morphine equivalents.|Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2|Intention to treat analysis|||mg||Standard Deviation|Mean
1412344|NCT01163214|Primary|Post-Operative Pain|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
1412345|NCT01163214|Secondary|Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)|Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).|Afternoon on post-operative Day 1, approximately 14:00|In the nerve block arm 5 subjects were excluded (3 subjects were not treated as planned, and 1 subject received a sciatic catheter instead of a single injection, and 1 subject previously had a nerve block procedure.) In the periarticular injection arm 4 patients were excluded (3 subjects were not treated as planned, and 1 subject was too heavy.)|||units on a scale||Standard Deviation|Mean
1412346|NCT01163162|Primary|24-hour Urine Creatinine Excretion Rate|We expect the 24 hour urine creatinine excretion rate to show no differences between groups.|1 Week||||mg/24hour/day||95% Confidence Interval|Mean
1412349|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Mineralization Lag Time|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Mineralization Lag Time (days). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)|||days||Standard Deviation|Mean
1412350|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Thickness|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Thickness (um). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)|||um||Standard Deviation|Mean
1412351|NCT01163149|Secondary|Change From Baseline in HPP-related Osteomalacia as Measured by Trans-iliac Crest Bone Biopsy: Osteoid Volume/Bone Volume|A trans-iliac crest bone biopsy was performed to quantify changes from Baseline in histomorphometric parameters relevant for evaluation of osteomalacia severity, including Osteoid Volume/Bone Volume (%). The difference in time under observation between asfotase alfa groups (Week 48) and control group (Week 24) resulted from study design, ie, control subjects transitioned to active treatment after the Week 24 visit.|Baseline, Week 24 (Control group), and Week 48 (Asfotase alfa groups).|Full analysis set (intent-to-treat, all randomized patients)|||percentage of volume||Standard Deviation|Mean
1412352|NCT01163149|Secondary|Change in Walking Ability as Measured by the Six-Minute Walk Test (6MWT)|The patient was instructed to walk the length of a pre-measured hallway for 6 minutes. The primary measurement was distance walked (in meters).|Baseline, Week 24 (primary treatment period) and up to 288 weeks of asfotase alfa exposure|Full analysis set (intent-to-treat, all randomized patients). Among the 6 control subjects, only 4 had both a Baseline and Week 24 value.|||meters||Standard Deviation|Mean
1412353|NCT01163149|Secondary|Change From Baseline in Bone Mineral Density (BMD) as Measured by Dual-energy X-ray Absorptiometry (DXA)|A DXA scan was performed to evaluate bone bone mineral density (BMD) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks).|Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.|Full analysis set (intent-to-treat, all randomized patients)|||g/cm2||Standard Deviation|Mean
1412354|NCT01163149|Secondary|Change From Baseline in Bone Mineral Content (BMC) as Measured by Dual-energy X-ray Absorptiometry (DXA)|A DXA scan was performed to evaluate bone mineral content (BMC) of the spine, hip, and whole body during the primary (first 24 weeks) and extension treatment periods (up to 288 weeks).|Baseline, every 24 weeks through Week 96, then every 48 weeks until Week 288.|Full analysis set (intent-to-treat, all randomized patients)|||g||Standard Deviation|Mean
1412355|NCT01163149|Primary|Safety and Tolerability of Asfotase Alfa|The safety and tolerability of daily subcutaneous (SC) injections of asfotase alfa was assessed by routine monitoring of patients for treatment-emergent adverse events (TEAEs) and injection-associated reactions (IARs).|Up to 288 weeks exposure to asfotase alfa|Safety Set. Control group and asfotase alfa Cohorts during the primary treatment period (first 24 weeks of study); all patients with asfotase alfa exposure during open-label extension treatment period.|||Number of Treatment-Emergent Events|||Number
1412356|NCT01163149|Primary|Change From Baseline to Week 24 for Plasma Inorganic Pyrophosphate (PPi)|Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma inorganic pyrophosphate (PPi)|Baseline, Week 24|Full analysis set (intent-to-treat, all randomized patients)|||uM||Standard Deviation|Mean
1412357|NCT01163149|Primary|Change From Baseline to Week 24 for Plasma Pyridoxal-5' Phosphate (PLP)|Blood samples were collected to evaluate the effect of asfotase alfa on reduction in plasma pyridoxal-5' phosphate (PLP)|Baseline, Week 24|Full analysis set (intent-to-treat, all randomized patients)|||ng/mL||Standard Deviation|Mean
1412358|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
1412359|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
1412360|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
1412361|NCT01163097|Secondary|Ratio to Baseline of Albumin/Creatinine|"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
1413708|NCT01151852|Secondary|Overall Survival(OS) and Time to Progression(TTP)|To compare the overall survival (OS) and time to progression (TTP) in both arms of the study|Up to 3years||||Months||95% Confidence Interval|Median
1412362|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 3|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
1412363|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 2|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
1412364|NCT01163097|Secondary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 1|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||Standard Deviation|Mean
1412365|NCT01163097|Secondary|Subject Incidence of Proteinuria|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.~Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||participants|||Number
1412366|NCT01163097|Secondary|Subject Incidence of Treatment-emergent Adverse Event|Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C).|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C)|||participants|||Number
1412367|NCT01163097|Secondary|Palifermin PK Parameters: Vss|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||mL/Kg||Geometric Coefficient of Variation|Geometric Mean
1412368|NCT01163097|Secondary|Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1412369|NCT01163097|Secondary|Palifermin PK Parameters: C0|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1412370|NCT01163097|Secondary|Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1412371|NCT01163097|Secondary|Palifermin PK Parameters: AUC (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1412614|NCT01160822|Secondary|Patient’s Global Assessment of Response to Treatment on Day 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412372|NCT01163097|Secondary|Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation."|Day 1|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1412373|NCT01163097|Secondary|Palifermin PK Parameters: CL|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 3|The pharmacokinetics population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
1412374|NCT01163097|Secondary|Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)|"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero."|Day 1|The pharmacokinetics (PK) population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) and at least one post dose PK serum sample|||(mL/hr/kg)||Geometric Coefficient of Variation|Geometric Mean
1412375|NCT01163097|Primary|Ratio to Baseline of Protein/Creatinine|"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio."|Day 4|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment B and C only as per study plan.|||ratio||95% Confidence Interval|Geometric Mean
1412376|NCT01163097|Primary|Ratio to Baseline of Lipase.|Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.|||ratio||95% Confidence Interval|Geometric Mean
1412377|NCT01163097|Primary|Ratio to Baseline of Amylase|Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase.|Day 5|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B) or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.|||ratio||95% Confidence Interval|Geometric Mean
1412378|NCT01163097|Primary|Incidence of Grade 2 or Higher Specific Skin-related Adverse Events.|"Incidence of grade 2 or higher specific skin-related treatment emergent adverse events following palifermin administration was calculated for subjects in treatment groups A and B. Incidence was calculated by treatment as number of subjects with grade 2 or higher specific skin-related AEs divided by the total number of subjects.~The Common Terminology Criteria for Adverse Events (CTCAE v3.0) for Dermatology/Skin was used to determine the toxicity grade for a skin-related adverse event. (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf)"|Day 45|The safety population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C). This outcome was assessed for Treatment A and B only as per study plan.|||proportion of participants|||Number
1412379|NCT01163097|Primary|Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.|This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment.|Day 4|The pharmacodynamic population consist of all randomized subjects who received at least one dose of palifermin (Treatment A or B), or who had a set zero point (Treatment C) and had both baseline and Day 4 buccal biopsy samples collected. This analysis was only performed for Treatment A relative to Treatment B as per study plan.|||ratio||90% Confidence Interval|Geometric Mean
1412380|NCT01163032|Secondary|Number of Patients With a Treatment Emergent Adverse Event (Open Label Extension Phase Only)|Adverse events were recorded in the source documents from the time of the patient’s informed consent signature until the end of the patient’s study participation. An AE was defined as any untoward medical occurrence in a clinical investigation patient who does not necessarily have causal relationship with treatment.|6 months|One subject who rolled into the OLE from the randomized phase (tasimelteon) experienced an unrelated TEAE during the OLE phase.|||participants|||Number
1412381|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 2 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
1412626|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36||||percentage of drop seizures||Full Range|Median
1412382|NCT01163032|Post-Hoc|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 45 Minutes) and UQ-dTSD (≤ 45 Minutes)|Responder analysis with responder defined as an increase of 45 minutes or more in (LQ-nTST) and a decrease of 45 minutes or more in (UQ-dTSD).|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
1412383|NCT01163032|Secondary|Average Midpoint of Sleep (MoST)|Midpoint of Sleep Timing (MoST) is the measurement of the average midpoint of sleep time relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||minutes||Standard Error|Mean
1412384|NCT01163032|Secondary|Average Upper Quartile of Days of Subjective Daytime Sleep Duration (UQ-dTSD)|UQ-dTSD measures the difference in average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) between the randomized phase (6 months) and the screening phase (~ 6 weeks). Lower number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||minutes||Standard Error|Mean
1412385|NCT01163032|Secondary|Average Lower Quartile of Nights of Nighttime Total Sleep Time (LQ-nTST)|LQ-nTST measures the difference in average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) between the randomized phase (6 months)and the screening phase (~ 6 weeks). The higher number indicates improvement.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||minutes||Standard Error|Mean
1412386|NCT01163032|Secondary|Proportion of Responders With a Combined Sleep/Wake Response for LQ-nTST (≥ 90 Minutes) and UQ-dTSD (≤ 90 Minutes)|The sleep/wake response represents measurement of the combined improvement in the nighttime sleep duration and daytime sleep duration. Individuals that have an improvement in nighttime sleep and daytime sleep, defined as an increase of 90 minutes or more in the lower quartile of subjective nighttime total sleep time (LQ-nTST) and a decrease of 90 minutes or more in the upper quartile of daytime total sleep duration (UQ-dTSD) are considered to be a responder.|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
1412387|NCT01163032|Secondary|Average Clinical Global Impression of Change (CGI-C)|CGI-C scores range from 1 (very much improved) to 7 (very much worse). The average post-randomization score was obtained for each patient by averaging the last 2 scheduled assessments (Day D112 and Day D183). Lower number indicates improvement.|Day 112 and 183|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||score||Standard Error|Mean
1412388|NCT01163032|Secondary|Proportion of Patients Entrained as Assessed by Urinary Cortisol|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four 48 hour periods, approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.|||percentage of patients|||Number
1412389|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response (Score of ≥ 3 on N24CRS)|"Non-24 Clinical Response Scale (N24CRS) was a 4-item scale which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline"|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
1412390|NCT01163032|Other Pre-specified|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 2 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 2 on the Non-24 Clinical Response Scale (N24CRS) which includes LQ-nTST, UQ-dTSD, MoST and CGI-C assessments. Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline~For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
1412402|NCT01162499|Primary|Mean Plasma Glucose Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma glucose levels samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||mg*min/dl||Standard Error|Mean
1412627|NCT01160770|Primary|Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment|Number of drop seizures was obtained from seizure diaries|Baseline to month 36||||percentage of drop seizures||Full Range|Median
1412391|NCT01163032|Primary|Proportion of Patients With a Clinical Response: Entrainment of aMT6 and Score of ≥ 3 on N24CRS|"Clinical response is defined as the coincident demonstration of entrainment (aMT6) and a score ≥ 3 on the Non-24 Clinical Response Scale (N24CRS). N24CRS measures improvement in sleep-wake measures and overall functioning (LQ-nTST, UQ-dTSD, MoST and CGI-C). Each assessment is scored as a 1 or 0 depending on the pre-specified threshold (see below).~LQ-nTST: >45 minutes increase in average nighttime sleep duration; UQ-dTSD: >45 minutes decrease in average daytime sleep duration; MoST: >30 minutes increase and a standard deviation <2 hours during double-masked phase (6 months); CGI-C: <2.0 from the average of D112 and Day 183 compared to baseline~For patients randomized to tasimelteon 20 mg and who also participated in the screening phase of Study 3203 (month 7 of treatment), the screening τ from Study 3203 was used if the patient did not become entrained in Study 3201 but did become entrained during the screening phase of Study 3203."|6 months|Analysis Population: all patients in the ITT population that had at least 70% of 1 circadian cycle of nighttime total sleep data reported during each phase (screening and post-randomization)|||percentage of patients|||Number
1412392|NCT01163032|Primary|Proportion of Patients Entrained as Assessed by Urinary aMT6|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four 48 hour periods , collected approximately 1 week apart for 4 separate weeks, during the screening and month 1 of the randomization phase of the trial. Entrainment was defined as having a post-baseline τ value less than 24.1 and a 95% CI that included 24.0.|1 month|Intent-to-Treat (ITT) Population: all subjects randomized into the study that have τ calculated post-randomization.|||percentage of patients|||Number
1412393|NCT01162863|Secondary|Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index|Change in the motility index defined as the natural log [(sum of pressure amplitudes times the number of contractions) + 1] for the small bowel and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days||||units on a scale||Standard Deviation|Mean
1412394|NCT01162863|Secondary|Change in Small Bowel pH and Colon pH From Baseline|Change in the mean pH of the small intestine and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.|21-28 days||||pH||Standard Deviation|Mean
1412395|NCT01162863|Primary|Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline|Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm|21-28 days||||hours||Standard Deviation|Mean
1412396|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 12 Hours|Percentage of patients reaching a therapeutic level defined as greater than 15 mcg/mL|12 hours||||percentage of participants|||Number
1412397|NCT01162733|Primary|Percentage of Participants First Achieving Therapeutic Levels at 36 Hours|The objective is to determine if therapeutic levels were reached more rapidly with the implementation of an initial vancomycin loading dose of 30 mg/kg as compared to 15mg/kg.|36 hours||||percentage of participants|||Number
1412398|NCT01162499|Secondary|Peak Glucagon Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various 3 hours after the start of the infusion. The mean peak glucagon concentration for both Exendin-(9-39) doses were compared with the peak glucagon during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences in peak glucagon concentration were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||pg/ml||Standard Error|Mean
1412399|NCT01162499|Secondary|Peak Plasma Glucagon-like Peptide-1 (GLP-1) Concentration During Infusion|To examine the effect of Exendin-(9-39) on plasma glucagon-like peptide-1 levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion. The mean peak glucagon-like peptide-1 concentration for both Exendin-(9-39) doses were compared with the peak glucagon-like peptide-1 during vehicle infusion.|60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the infusion|Differences were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||pmol/l||Standard Error|Mean
1412400|NCT01162499|Secondary|Mean Acetaminophen Plasma Concentration Area Under the Curve (AUC 0-3h)|The effect of gastric emptying was examined using the acetaminophen method whereby acetaminophen (30mg/kg or maximum of 1500mg) was mixed into the Pediasure/formula during the meal tolerance testing. Blood samples were collected every 30 minutes and the absorption of acetaminophen was determined by the gastric emptying rate, as the serum concentrations correlate with gastric emptying of liquids. Mean acetaminophen levels for each group at each time point were used to calculate the Area Under the Concentration versus Time Curve (AUC expressed in μg*min/l) after the consumption of formula for each of the two Exendin-(9-39) dose levels and normal saline vehicle.|3 hours|AUC were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||μg*min/l||Standard Error|Mean
1412401|NCT01162499|Secondary|Mean Plasma Insulin Area Under the Curve (AUC 0-3h)|To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion [Exendin-(9-39) or vehicle] including: 60 minutes before the start of the infusion, again at the start of the infusion (time 0), and then every 30 minutes until 3 hours after the start of the meal. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (3 hours) was calculated for both doses of Exendin-(9-39) [300pmol/kg/min & 500pmol/kg/min] and compared with the vehicle.|3 hours|Changes were compared between the two dose levels of Exendin-(9-39) of 300pmol/kg/min (3 subjects) and 500pmol/kg/min (3 subjects) were compared to the vehicle infusion (all 6 subjects).|||pmol*min/l||Standard Error|Mean
1412674|NCT01160380|Primary|BFI Score|Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10|Day 1, Day 28 and Day 56||||units on a scale||Standard Deviation|Mean
1412403|NCT01162473|Primary|Number of Subjects Who Completed Desensitization Protocol|"Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be treatment failures. Subjects who completed the desensitization protocol were considered to be treatment successes."|1 year|The analysis population included all subjects who began desensitization per protocol.|||participants|||Number
1412404|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.|||Canadian dollars||Standard Deviation|Mean
1412405|NCT01162421|Secondary|HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.|||Canadian dollars||Standard Deviation|Mean
1412406|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=2, 3 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).|||percentage of participants|||Number
1412407|NCT01162421|Secondary|HCR: Health Care for RA in the Past 4 Weeks at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=11, 10 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).|||percentage of participants|||Number
1412408|NCT01162421|Secondary|HCR: Medical Insurance at Final Visit|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l’assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L’indemnisation des victimes d’actes criminals (IVAC).|Final Visit (up to Month 24)|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=26, 26 is the number of participants who answered that they did have health insurance).|||percentage of participants|||Number
1412409|NCT01162421|Secondary|Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline|The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l’assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L’indemnisation des victimes d’actes criminals (IVAC).|Baseline|Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=25, 28 is the number of participants who answered that they did have health insurance).|||percentage of participants|||Number
1412410|NCT01162421|Secondary|Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24|"Participants measured their satisfaction with care by specifying their in response to the question How satisfied are you with the results of your RA treatment? on a 5-point Likert scale, from the following 5 answers: not satisfied, a little satisfied, moderately satisfied, well satisfied, very well satisfied. Scores range from 1 to 5, with higher scores indicating more satisfaction with their care."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412411|NCT01162421|Secondary|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412412|NCT01162421|Secondary|Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412413|NCT01162421|Secondary|Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24|The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state).|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
1412414|NCT01162421|Secondary|Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24|The WLQ was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
1412415|NCT01162421|Secondary|Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. The MCID was defined as a 3.56-unit decrease in FACIT-Fatigue Scale.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
1412416|NCT01162421|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412417|NCT01162421|Secondary|Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving HAQ < 0.5. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
1412418|NCT01162421|Secondary|Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24|The percentage of participants achieving MCID in HAQ, defined as a 0.22 unit decrease in HAQ. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
1412419|NCT01162421|Secondary|Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24|HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412430|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||tender joints||Standard Error|Least Squares Mean
1412420|NCT01162421|Secondary|Percentage of Participants With Flare-Up After Remission by Month 24|Percentage of participants with a flare-up after remission by Month 24, defined as participants who reached remission (DAS28 < 2.6) but later had two consecutive visits with DAS28 ≥ 2.6 (based on observed cases only). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment.|||percentage of participants|||Number
1412421|NCT01162421|Secondary|Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Moderate EULAR Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and < 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or an improvement (decrease) in the DAS28 of ≥ 1.2 from Baseline and attainment of a DAS28 score of > 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
1412422|NCT01162421|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24|A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of ≥ 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
1412423|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) low disease activity was defined as DAS28(CRP) < 3.2. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
1412424|NCT01162421|Secondary|Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24|DAS28(CRP) remission was defined as DAS28(CRP) < 2.6. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).|||percentage of participants|||Number
1412425|NCT01162421|Secondary|Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
1412426|NCT01162421|Secondary|Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24||Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.|||mg/L||Standard Error|Least Squares Mean
1412427|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how severe their pain had been in the previous week on a VAS from 0 (no pain) to 100 (pain as bad as it could be). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412428|NCT01162421|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Participants were asked to indicate how they were doing with their RA on a VAS from 0 (very well) to 100 (very poorly). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412429|NCT01162421|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24|Physicians were asked to indicate the participant’s disease activity (independent of the participant's self assessment) on a visual analogue scale (VAS) from 0 (very good) to 100 (very bad). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
1412450|NCT01162122|Secondary|Number of Subjects Reporting Solicited Adverse Events Following Vaccination|The number of subjects reporting solicited local and systemic adverse events and other adverse events in aTIV group compared to TIV group.|Day 1 through Day 7 post vaccination|Analysis was done on the safety set i.e all randomized subjects who received a study vaccination and provided postvaccination safety data.|||participants|||Number
1446875|NCT00877929|Secondary|SBP Control 140 at One Week|Mean seated SBP < 140 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
1412431|NCT01162421|Secondary|Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-68, with higher scores indicating more tender joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||tender joints||Standard Error|Least Squares Mean
1412432|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||swollen joints||Standard Error|Least Squares Mean
1412433|NCT01162421|Secondary|Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-66, with higher scores indicating more swollen joints.|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||swollen joints||Standard Error|Least Squares Mean
1412434|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR70 responder if the following 3 criteria for improvement from Baseline are met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters: -~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
1412435|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR50 responder if the following 3 criteria for improvement from Baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/CRP)."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
1412436|NCT01162421|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24|"A participant is an ACR20 responder if the following 3 criteria for improvement from Baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters: -~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein [CRP])."|Baseline, Months 3, 6, 9, 12, 18, 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
1412437|NCT01162421|Secondary|Percentage of Participants With Rapid Radiographic Progression at Month 12|Radiographic progression was defined as a change from Baseline in mTSS that is ≥ 5 units. The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug ith an assessment (nonresponder imputation).|||percentage of participants|||Number
1412438|NCT01162421|Secondary|Change From Baseline in mTSS at Months 6, 12 and 24|The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 12, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug; n=number of participants with an assessment at Baseline and given timepoint (observed cases).|||units on a scale||Standard Error|Least Squares Mean
1412451|NCT01162122|Secondary|All Cause Mortality Rate, Across Vaccine Groups|The all-cause mortality rate (excluding injury)reported in aTIV group compared to TIV group, by country.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).|||participants|||Number
1412452|NCT01162122|Secondary|Number of Subjects Reporting Healthcare Utilization Across Vaccine Groups|The number of subjects with emergency room visits, unscheduled physician visits, and hospitalizations due to community acquired influenza or pneumonia, cardiopulmonary disease, cardiac disease, respiratory or pulmonary disease,in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness).|||participants|||Number
1446876|NCT00877929|Secondary|SBP Control 140 at Two Weeks|Mean seated SBP < 140 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
1412439|NCT01162421|Secondary|Percentage of Participants With No Radiographic Progression at Month 6 and Month 24|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 6, Month 24|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).|||percentage of participants|||Number
1412440|NCT01162421|Primary|Percentage of Participants With No Radiographic Progression at Month 12|Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Month 12|Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF): missing responses were imputed by carrying forward the last non-missing post-baseline observation.|||percentage of participants|||Number
1412441|NCT01162343|Primary|Delirium|Delirium was diagnosed by a consultation-liaison psychiatrist assessment using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The psychiatrists performed a battery of bedside cognitive tests, including (but not limited to) Clock Drawing Test, Luria hand sequencing task, and tests for verbal fluency. A focused neurological examination (i.e., screening for paraphasic errors, tremors, tone, asterixis, frontal release signs etc.,) and evaluation for affective lability, hallucinations, and level of alertness were also conducted routinely. Confrontational naming, proverb interpretation or similarities, and assessments for apraxias were performed at the discretion of the reference psychiatrists, especially if the diagnosis of delirium was inconclusive.|Within 3 hours of the study assessments.||||percent||95% Confidence Interval|Number
1412442|NCT01162317|Secondary|Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency|Wrist actigraphy is a non-invasive method of continuously monitoring gross body activities when a watch-like actimetry sensor is worn at the non-dominant wrist. An algorithm has been developed to assess sleep/wake behavior. Specifically in this study, we used Respironics® actiwatches for data collection. Subjects were asked to wear the actiwatches for a consecutive week at baseline and then at post-intervention, and the actiwatches were taken off only during showers. Wrist actigraphy was examined in association with sleep diary the subjects were to keep for the weeks of monitoring. Threshold-based method algorithm for data interpretation was provided by Respironics® Actiware Software. Medium level threshold was set to detect Wake and Sleep; sleep interval detection algorithm was set for 3 minutes of immobile minutes for Sleep Onset and 5 minutes of immobile minutes for Sleep End. Sleep efficiency is sleep duration divided by total bed time (both in minutes), times 100%.|pre-intervention, post-intervention (1wk of recording each)|All obtained actigraphy data were analyzed. This form doesn't allow specific indication of sample sizes. Therefore, here overall numbers of participants analyzed were the same as the maximal potential.|||percentage||Standard Deviation|Mean
1412443|NCT01162317|Primary|PSQI Change|"change of global PSQI score as compared to baseline The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.~The PSQI global score has a possible range of 0–21 points. Any score above 5 is considered insomnia. The higher the score the worse the condition."|Baseline and post-intervention||||change of points from baseline||Standard Deviation|Mean
1412444|NCT01162304|Secondary|Patient Global Impression of Change|This rating on a 7-point scale measures a patients overall assessment of change since starting a given treatment. This measure provides a subjects global assessment of change, presumably including change in pain, side effects, change in functional status, convenience of therapy, subject preference and values and overall satisfaction with the intervention.|Visits 4 and 6 the end of each of the two treatment periods|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
1412445|NCT01162304|Secondary|Short Form Health Survey (SF-36)|It is a 36-item questionnaire designed to measure general health related quality of life.|Visits 2, 4 and 6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
1412446|NCT01162304|Secondary|Hospital Anxiety and Depression Scale|The HADS will be administered to assess anxiety and depression.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
1412447|NCT01162304|Secondary|Brief Pain Inventory|Will be administered to assess the extent to which chronic pain interferes with sleep and physical and emotional functioning.|Visits 2-6|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
1412448|NCT01162304|Primary|Numerical Pain Rating Scale (NRS)|The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p < 0.05 level using a two-tailed test.|Daily|Due to not reaching enrollment goal of 40 subjects, data collected on the 7 participants enrolled was not analyized because the data is not available the data are locked not able to obtain.||||||
1412449|NCT01162135|Primary|Rate of Positive PSADT Outcome|Proportion of patients at 6 months post-treatment with a PSADT >= 200% from baseline|6 months after treatment with digoxin||||participants|||Number
1412453|NCT01162122|Secondary|Number of High Risk Subjects With Exacerbation of Preexisting Chronic Disease, Across Vaccine Groups|The number of high risk subjects reporting exacerbation of preexisting chronic conditions (i.e.congestive heart failure, Chronic Obstructive Pulmonary disease (COPD), asthma, hepatic disease, renal insufficiency, and neurological/neuromuscular or metabolic disorders including diabetes mellitus) in aTIV group compared to TIV group.|Day 1 through Day 366 post vaccination|Analysis was done on the mFAS (effectiveness) population.|||participants|||Number
1412454|NCT01162122|Secondary|Number of Subjects Reporting Influenza Like Illness (ILI) Across Vaccine Groups|The number of subjects reporting ILI from three weeks after vaccination to up to one year in aTIV group compared to TIV group, by country.|Day 22 through Day 366 post vaccination|Analysis was done on the modified full analysis set (mFAS; effectiveness) population i.e all subjects in the randomized population who received a study vaccination but excluding those who received a non-study vaccine during the follow-up phase.|||participants|||Number
1412455|NCT01162122|Secondary|Percentage of Subjects With Seroconversion Upto One Year After Vaccination, Against Homologous and Heterologous Strains|"The percentage of subjects demonstrating seroconversion in HI titers against homologous and heterologous strains, at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset.|||Percentage of subjects||95% Confidence Interval|Number
1412456|NCT01162122|Secondary|Persistence of GMTs Against Homologous and Heterologous Strains|The GMTs against homologous and heterologous strains, persisting in subjects at six months (day 181) and one year (day 366) after vaccination with either aTIV or TIV.|Day 181, Day 366 post vaccination|The analysis was done on the FAS (persistence) subset population i.e all randomized population only from US sites who received a study vaccination, provided evaluable blood samples at day 1, day 22, day 181, and day 366.|||Titers||95% Confidence Interval|Geometric Mean
1412457|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of percentage of subjects achieving seroconversion, at three weeks after vaccination.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS|||Percentage of subjects||95% Confidence Interval|Number
1412458|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in Terms of Percentage of Subjects Achieving Seroconversion Against Heterologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous strains, in overall group and in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on PPS.|||Percentage of subjects||95% Confidence Interval|Number
1412459|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination.|Day 22 post vaccination|Analysis was done on FAS.|||Titers||95% Confidence Interval|Geometric Mean
1412460|NCT01162122|Secondary|Comparison of aTIV Versus TIV in Terms of GMTs Against Heterologous Strains-PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV against the heterologous vaccine strains, in overall group and in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination .|Day 22 post vaccination|Analysis was done on PPS.|||Titers||95% Confidence Interval|Geometric Mean
1412461|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 postvaccination|Analysis was done on FAS.|||Percentage of subjects||95% Confidence Interval|Number
1412462|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Heterologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
1412463|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers, Against Heterologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
1412464|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Heterologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against heterologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
1412465|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-FAS|The superiority of HI antibody responses of aTIV compared to TIV, in subjects with predefined co-morbidities (high risk group) assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS population.|||Titers||95% Confidence Interval|Geometric Mean
1412466|NCT01162122|Secondary|Comparison of HI Antibody Responses of aTIV Versus TIV, in High Risk Group in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk group), assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the homologous vaccine strains.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.|||Percentage of subjects||95% Confidence Interval|Number
1412467|NCT01162122|Secondary|Comparison of aTIV Versus TIV in High Risk Group in Terms of GMTs Against Homologous Strains-PPS|The non-inferiority of HI antibody responses of ATIV compared to TIV, in subjects with pre-defined co-morbidities (high risk subjects), was assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.|||Titers||95% Confidence Interval|Geometric Mean
1412468|NCT01162122|Primary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers (day 22/day 1) in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS|||Ratio||95% Confidence Interval|Geometric Mean
1412469|NCT01162122|Primary|Percentage of Subjects Achieving Seroconversion in HI Titers, Against Homologous Strains|"The percentage of subjects achieving seroconversion in HI titers from baseline, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.~Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
1412470|NCT01162122|Primary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains|The percentage of subjects demonstrating HI titers ≥40, in overall group and in subjects with pre-defined co-morbidities (high risk group), against homologous strains, three weeks after vaccination with aTIV or TIV.|Day 22 post vaccination|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
1412471|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-FAS|"The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on FAS.|||Percentage of subjects||95% Confidence Interval|Number
1412472|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of GMTs Against Homologous Strains-Full Analysis Set (FAS)|The superiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on FAS i.e all randomized subjects who received a study vaccination and provided evaluable serum samples both at day 1 and at day 22|||Titers||95% Confidence Interval|Geometric Mean
1412473|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Percentage of Subjects Achieving Seroconversion Against Homologous Strains-PPS|"The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of percentage of subjects achieving seroconversion at three weeks after vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 22 post vaccination|Analysis was done on PPS.|||Percentage of subjects||95% Confidence Interval|Number
1412474|NCT01162122|Primary|Comparison of aTIV Versus TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains - PPS|The non-inferiority of HI antibody responses of aTIV compared to TIV assessed in terms of post vaccination GMTs at three weeks after vaccination against the three homologous vaccine strains.|Day 22 post vaccination|Analysis was done on PPS.|||Titers||95% Confidence Interval|Geometric Mean
1412475|NCT01162122|Primary|Geometric Mean Titers in Subjects After Receiving One Dose of Lot 1 or Lot 2 or Lot 3 of aTIV|Immunologic equivalence of 3 consecutive production lots of aTIV (Lot 1, Lot 2 and Lot 3), was assessed in terms of Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) in subjects, at three weeks after vaccination, against each vaccine strain.|Day 22 post vaccination|Analysis was done on the per protocol set population (PPS) i.e all randomised subjects who received the correct vaccine, provided evaluable serum samples, and had no major protocol deviation prior to unblinding.|||Titers||95% Confidence Interval|Geometric Mean
1412476|NCT01162096|Secondary|Immune Reconstitution||Up to 5 years||||cells/ul||Full Range|Median
1412477|NCT01162096|Secondary|Number of Participants With Successful Engraftment||6 months|32 patients are evaluable for engraftment|||Participants|||Count of Participants
1412478|NCT01162096|Primary|Overall Survival at 6 Months Post-transplant in Patients Receiving a Partially-matched Related Donor Allogeneic Transplant After Reduced-intensity Conditioning|Number of patients alive at 6 months post-transplant|6 months||||Participants|||Count of Participants
1412479|NCT01161862|Secondary|Nadir Blood Glucose in Each Arm||48 hours||||mg/dl||Standard Deviation|Mean
1412480|NCT01161862|Secondary|Number of Blood Glucose Events < 70 mg/dl||48 hours||||Number of events|||Number
1412481|NCT01161862|Secondary|Number of Carbohydrate Interventions for Hypoglycemia||48 hours|Overall number of participants=24 (12 in each arm)|||Carbohydrate Interventions|||Number
1412482|NCT01161862|Secondary|Insulin Total Daily Dose||48 hours|Overall number of participants=24 (12 in each arm)|||u/kg/day||Standard Deviation|Mean
1412483|NCT01161862|Secondary|Percentage of Time Spent With Blood Glucose 70-180 mg/dl||48 hours|Overall number of participants=24 (12 in each arm)|||percentage of total time||Standard Deviation|Mean
1412484|NCT01161862|Secondary|Percentage of Time Spent With Blood Glucose <70 mg/dl||48 hours|Overall number of participants=24 (12 in each arm)|||percentage of total time||Standard Deviation|Mean
1412485|NCT01161862|Secondary|Percentage of Time Spent With Blood Glucose < 60 mg/dl||48 hours|Overall number of participants=24 (12 in each arm)|||percentage of total time||Standard Deviation|Mean
1412487|NCT01161771|Secondary|Change From Baseline in Schirmer's Test at Month 3|Change from baseline in Schirmer’s Test result at month 3. The Schirmer’s Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Millimeters of Tears||Standard Deviation|Mean
1412488|NCT01161771|Secondary|Change From Baseline in Tear Break-Up Time at Month 3|Change from baseline in tear break-up time (TBUT) at month 3. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Seconds||Standard Deviation|Mean
1412489|NCT01161771|Secondary|Change From Baseline in Conjunctival Staining at Month 3|Change from baseline in conjunctival staining severity score at month 3. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0= no staining, 5= severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement)|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Scores on a Scale||Standard Deviation|Mean
1412490|NCT01161771|Secondary|Change From Baseline in Corneal Staining at Month 3|Change from baseline in corneal staining at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A positive number change from baseline represents an increase in corneal staining (worsening of dry eye).|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Scores on a Scale||Standard Deviation|Mean
1412491|NCT01161771|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3|Change from baseline in OSDI total score at month 3. The OSDI is a 12-question survey for subjects to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Scores on a Scale||Standard Deviation|Mean
1412492|NCT01161771|Primary|The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured|The percentage of subjects at month 3 with corneal sensitivity < 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.|Month 3|Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.|||Percentage of Subjects|||Number
1412493|NCT01161628|Secondary|Incidence of Non-relapse Mortality||2 years||||percentage of patients|||Number
1412494|NCT01161628|Secondary|Incidence of Disease-free Survival||2 years|Of the surviving patients at 2 years (82% of initial enrolled population)|||percentage of patients|||Number
1412495|NCT01161628|Secondary|Duration of Systemic Corticosteroid Use||2 years|Only 2 patients out of the 22 evaluable patients enrolled received steroids during the course of treatment for cGVHD. A total of 25 patients were enrolled; 3 patients were excluded from this analysis due to treatment failure.|||days||Full Range|Median
1412496|NCT01161628|Primary|Rate of Partial Response of cGVHD to Treatment||2 years||||percentage of patients|||Number
1412497|NCT01161628|Primary|Rate of Overall Response of cGVHD to Treatment||2 years||||percentage of patients|||Number
1412498|NCT01161628|Secondary|Incidence of Overall Survival||2 years||||percentage of patients|||Number
1412499|NCT01161628|Secondary|Time to Immunosuppression Withdrawal||2 years||||days||Full Range|Median
1412500|NCT01161628|Secondary|Requirement for Systemic Corticosteroid Use||2 years|20 out of the 25 patients enrolled received no corticosteroids at all during the course of treatment for cGVHD|||participants|||Number
1412501|NCT01161628|Primary|Rate of Complete Response of cGVHD to Treatment.||2 years||||percentage of patients|||Number
1412502|NCT01161563|Secondary|Discomfort From Injection|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires.|||units on a scale||95% Confidence Interval|Mean
1412503|NCT01161563|Primary|Patient Bother From Injection Site Burning and/or Stinging|Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection|15 minutes|Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.|||units on a scale||95% Confidence Interval|Mean
1412523|NCT01161498|Primary|2-year Event-free Survival|Event-free survival is defined as the time from randomization until the first evidence of relapse, disease progression (local, regional, metastatic, or second primary), or death from any cause. Because this study was terminated with only 5 participants enrolled, and the study was terminated in the first year, this endpoint was not analyzed.|2 years|||||||
1412504|NCT01161537|Secondary|Part B: Absolute Change From Baseline in in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Week 48|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
1412505|NCT01161537|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 48|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||mmol/L||Standard Deviation|Mean
1412506|NCT01161537|Secondary|Part B: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 48|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|"FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure."|||percent predicted of FEV1||Standard Deviation|Mean
1412507|NCT01161537|Secondary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part B: Day 1 up to Week 48|Safety Set for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part B.|||participants|||Number
1412508|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score At Day 43|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||units on a scale||Standard Deviation|Mean
1412509|NCT01161537|Secondary|Part A: Absolute Change From Baseline in Sweat Chloride at Day 43|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||millimole per liter (mmol/L)||Standard Deviation|Mean
1412510|NCT01161537|Secondary|Part A: Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Day 43|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||percent predicted of FEV1||Standard Deviation|Mean
1412511|NCT01161537|Secondary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from subject’s baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug."|Part A: Day 1 up to Day 57|Safety Set for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A. Data was reported as per the intervention received (Placebo [Placebo Run in/Washout] or VX-770 [VX-770 Treatment]).|||participants|||Number
1412524|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT) on Day 6|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Words Recalled||Standard Error|Least Squares Mean
1412512|NCT01161537|Primary|Part B: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Week 48|Subjects were asked to inhale hyperpolarized 3 He gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid MRI was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in Part B (48 weeks).|Part B: Baseline (Day -1), Week 48|FAS for Part B = all enrolled subjects who received at least 1 dose of study drug (VX-770) in Part B.|||percentage of total lung volume||Standard Deviation|Mean
1412513|NCT01161537|Primary|Part A: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Day 43|Subjects inhaled hyperpolarized helium-3 (3He) gas mixed with nitrogen to make a total volume of approximately one-third forced vital capacity (FVC) to a maximum of 1 liter and hold their breath for 20 seconds or less. Rapid magnetic resonance imaging (MRI) was performed during inhalation/exhalation and/or breath-hold. Areas of decreased ventilation were observed as ventilation defects that are visualized as decreased (and/or absent) 3He intensity in 3He-MRI. The total ventilation defect was defined as the ratio of total ventilation defect volume (L) to total lung volume (L), expressed as a percentage. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug in VX-770 treatment phase (Day 15 to 42).|Part A: Baseline (pre-dose Day 15), Day 43|FAS for Part A = all enrolled subjects who received at least 1 dose of study drug (VX-770 or placebo) in Part A.|||percentage of total lung volume||Standard Deviation|Mean
1412514|NCT01161498|Secondary|Participants With N1-2 Disease at Baseline Requiring Neck Dissection|Participants with Baseline Nl or N2 disease (lymph node metastasis not more than 6 cm in greatest dimension) with persistent disease as determined at the post chemoradiotherapy assessment of response were to proceed to neck dissection as permitted by the institution no later than Week 22. Since this study terminated prematurely neck dissection data were not collected or analyzed.|Weeks 19 - 21|||||||
1412515|NCT01161498|Secondary|Disease-specific Survival|"Disease-specific survival is defined as the time from randomization to death of the patient due to the cancer under study.~Because this study was terminated with 5 participants enrolled, disease-specific survival was not analyzed."|Up to 5 years after chemoradiotherapy|||||||
1412516|NCT01161498|Secondary|Overall Survival|"Overall survival is defined as the time from randomization to death from any cause.~Because this study was terminated with 5 participants enrolled, overall survival was not analyzed."|Up to 5 years after chemoradiotherapy|||||||
1412517|NCT01161498|Secondary|Time to Any Failure|"Any failure is defined as disease progression at any site at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 participants enrolled, time to any failure was not analyzed."|Up to 27 months|||||||
1412518|NCT01161498|Secondary|Time to Distant Failure|"Distant failure is defined as disease progression at any site other than the head and neck area at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 participants enrolled, time to distant failure was not analyzed."|Up to 27 months|||||||
1412519|NCT01161498|Secondary|Time to Locoregional Failure|"Locoregional failure is defined as disease progression in the head and neck area at any time following completion of chemoradiotherapy.~Because this study was terminated with 5 subjects enrolled, time to locoregional failure was not analyzed."|Up to 27 months|||||||
1412520|NCT01161498|Secondary|Pathologic Complete Response (mCR)|"Response to therapy was assessed histopathologically from biopsies taken at surgery for those participants who had surgery prior to Week 22.~If no viable tumor cells were identified in surgical specimens (where the patient had surgery) the patient was classified as having a pathological complete response (pCR), and if viable tumor cells were identified, the patient was classified as having an incomplete pathologic response.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the pathologic complete response rate was not calculated. Therefore a summary of participants with a pathologic complete response before the end of study is reported."|Up to Week 20|Randomized participants who had protocol-specified surgery|||participants|||Number
1412521|NCT01161498|Secondary|Metabolic Complete Response (mCR)|"Response to therapy was assessed using [(18)F] fluorodeoxyglucose positron emission tomography (FDG PET) imaging to detect metabolically active tumors.~Metabolic complete response (mCR) is defined as complete disappearance of FDG uptake attributable to tumor compared to baseline scan.~Partial metabolic response (mPR) is defined as a > 40% decrease in specific uptake compared to the initial value in over half of the lesions.~Disease progression (mPD) is defined as a specific uptake increase in any lesion, appearance of new lesions, or presence of extended areas of disease activity.~Stable metabolic response (mSD) is defined as a decrease in uptake < 40% of the initial value of over half the lesions.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the metabolic complete response rate was not calculated. Therefore a summary of metabolic response at end of study is reported."|End of study; the maximum time on study was 20 weeks.|All randomized participants|||participants|||Number
1412522|NCT01161498|Secondary|Clinical Objective Response (cOR)|"Tumor response was assessed by computed tomography (CT) scan according to a modified version of the revised Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1). Objective response is defined as achieving a clinical partial response (cPR) or complete response (cCR). cCR is defined as disappearance of all baseline lesions. Any pathological lymph nodes must have a reduction in short axis to < 10 mm. cPR is defined as at least a 30% decrease in the sum of diameters of baseline lesions. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of baseline lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of any new lesions.~Because this study was terminated with 5 patients enrolled, data for this endpoint were summarized in by-patient listings only and the cOR rate was not calculated. Therefore a summary of response at the end of study is reported."|End of trial; the maximum time on study was 20 weeks.|All randomized participants|||participants|||Number
1414378|NCT01145898|Primary|3-year Change in CRA PSV|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
1412525|NCT01161472|Secondary|Rey Auditory Verbal Learning Test (RAVLT)|RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Words Recalled||Standard Deviation|Mean
1412526|NCT01161472|Secondary|Change From Baseline in CogState Groton Maze Learning Task on Day 6|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Error|Least Squares Mean
1412527|NCT01161472|Secondary|CogState Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Deviation|Mean
1412528|NCT01161472|Secondary|Change From Baseline in CogState CPAL on Day 6|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Error|Least Squares Mean
1412529|NCT01161472|Secondary|CogState Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Errors||Standard Deviation|Mean
1412530|NCT01161472|Secondary|Change From Baseline in CogState One Card Learning on Day 6|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Arcsine [(sqrt) proportion correct]||Standard Error|Least Squares Mean
1412531|NCT01161472|Secondary|CogState One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Arcsine [(sqrt) proportion correct]||Standard Deviation|Mean
1412532|NCT01161472|Secondary|Change From Baseline in CogState Identification Speed on Day 6|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Error|Least Squares Mean
1412568|NCT01161160|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to 21 days after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412533|NCT01161472|Secondary|CogState Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance.|Baseline|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Deviation|Mean
1412534|NCT01161472|Primary|Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline and Day 6|The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Error|Least Squares Mean
1412535|NCT01161472|Primary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|Baseline|The Per Protocol (PP) Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure.|||Log10 MS||Standard Deviation|Mean
1412536|NCT01161446|Secondary|Number of Male Condomless Anal Intercourse Partners in Last 3 Months||From 6 to 9 and 12 to 15 months|"Included Overall Number of Participants Analyzed as number who completed follow-up. However, only participants who responded to the question regarding condomless anal intercourse partners in the last 3 months were included in this analysis for each time point."|||number of partners||Standard Error|Mean
1412537|NCT01161446|Secondary|Bacterial Sexually Transmitted Infections|Includes syphilis, gonorrhea, and chlamydial infection|Assessed at 15 months|Includes only participants who received screening for sexually transmitted infections at the end-of-study visit.|||Participants|||Count of Participants
1412538|NCT01161446|Secondary|Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months||From 6 to 9 months and 12 to 15 months of follow-up|"Included Overall Number of Participants Analyzed as number who completed follow-up. However, only participants who responded to the question regarding non-concordant condomless anal intercourse in the last 3 months were included in this analysis for each time point."|||Participants|||Count of Participants
1412539|NCT01161446|Primary|HIV Testing Frequency|Number of HIV tests during follow-up reported by participants at end-of-study visit|15 months||||HIV tests||95% Confidence Interval|Mean
1412540|NCT01161420|Secondary|Percentage Sleep Time at SaO2 < 90%|"The percentage of time spent with oxygen saturation below 90% has been an increasingly utilized surrogate for morbidity risk in sleep apnea populations.~The SaO2 secondary endpoint in this study was determined by the time below an SaO2 level of 90% during the 12-month PSG study compared to that at baseline (average of screening and 1-month PSG studies). The objective was to demonstrate a decrease in the percentage of sleep time with an SaO2 level below 90% at 12 months."|12 months||||Percentage of Sleep Time SaO2 <90%||95% Confidence Interval|Mean
1412541|NCT01161420|Secondary|Change Epworth Sleepiness Scale (ESS) From Baseline to 12 Months|The Epworth Sleepiness Scale (ESS) is a validated instrument that rates a subject’s daytime sleepiness. Like the FOSQ, it is a quality of life measure that is commonly used in clinical evaluation and management of OSA. Scores range from 0 to 24, with lower scores indicating greater functioning. An ESS score of less than 10 is considered to be the cutpoint for normal subjective sleepiness.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
1412542|NCT01161420|Secondary|Change in FOSQ From Baseline to 12 Months|The Functional Outcomes Sleep Questionnaire (FOSQ) is a validated instrument that assesses the effect of a subject’s daytime sleepiness on activities of ordinary living. It is a quality of life measure that is commonly used in the clinical evaluation and management of OSA. This self-administered instrument consists of 30 questions divided into 5 domains: activity level, vigilance, intimacy, general productivity and social outcome. Scores range from 5 to 20, with higher scores indicating greater functioning. Change in FOSQ was calculated by subtracting the baseline score from the 12-month score.|Baseline and 12 months||||units on a scale||95% Confidence Interval|Mean
1412543|NCT01161420|Secondary|Modified Intent to Treat - AHI Responder Rate for All Implanted Subjects|"The intent-to-treat (ITT) analysis for the primary endpoint included all patients who underwent an implant. A modified ITT analysis was conducted to include the subjects who did not completed the 12-month follow-up sleep study also. The ITT analysis was to calculate the AHI responder rate based on the subjects included in the analysis as described below. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at their last visit.~The following subjects were included:~All implanted subjects who had AHI data collected at both baseline and 12-months follow-up.~All implanted subjects who had baseline data but no 12-month data, and had their last data values carried forward, provide they had a least 6-month AHI data.~Any implanted subject who did not have 12-month data available due to therapy failure (e.g., study withdrawal will be included in the analsys as a treatment failure."|12 months|Implanted subjects|||Number of subjects responding to therapy|||Number
1412559|NCT01161225|Primary|Asthma Control Questions|This measure assesses the frequencies of the limitation of daily activity, asthma symptoms (daytime and nighttime) and use of rescue medication in the past 4 weeks on a 5-point scale (0-4). Total summed scores were computed (range: 4-16). Higher total scores indicate better controlled asthma.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
1412544|NCT01161420|Secondary|AHI for the Randomized Controlled Therapy (RCT) Withdrawal Study|The AHI difference between the 12-month PSG study and the 13-Month PSG study in the therapy maintenance group will be compared to the AHI difference in the therapy withdrawal group. The objective was to demonstrate that AHI increase in the therapy withdrawal group (therapy=OFF) is greater than any AHI change in the active therapy group (therapy=ON). AHI is the number of apneas or hypopneas recorded during a sleep study per hour of sleep; this is calculated by dividing the number of AHI events by the number of hours of sleep.|12 Months|The first 46 responders to the Inspire therapy at 12 months were randomized 1:1 to either the Therapy Maintenance Group (ON) or the Therapy Withdrawal Group (OFF). A subsequent sleep study of the two randomized groups was conducted and results were compared between the two groups.|||events per hour||95% Confidence Interval|Mean
1412545|NCT01161420|Primary|Safety|The primary safety objective of this pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.|12 months||||Events Reported|||Number
1412546|NCT01161420|Primary|Oxygen Desaturation Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy ODI responder was defines as a subject who experienced at least a 25% reduction in ODI from baseline.|12 months||||percentage of subjects responding|||Number
1412547|NCT01161420|Primary|Apnea Hypopnea Index|Demonstrate at least a 50% responder rate at the 12-month follow-up visit. An Inspire therapy AHI responder was defined as a subject who experienced at least a 50% reduction in AHI from baseline and had an AHI of less than 20 at the 12-month follow-up.|12 months||||percentage of subjects responding|||Number
1412548|NCT01161407|Secondary|"Bone Balance From Calcium Kinetics"|Calcium kinetics was determined by a calcium radiotracer. Bone balance is the difference between bone formation and bone resorption estimated by calcium kinetic modeling.|2 weeks||||mg/d calcium||Standard Error|Least Squares Mean
1412549|NCT01161407|Secondary|Phosphorus Balance|Phosphorus balance is measured by dietary phosphorus intake (mg/d) minus phosphorus excretion (mg/d) from both urine and feces.|2 weeks||||mg/d phosphorus||Standard Error|Least Squares Mean
1412550|NCT01161407|Primary|Calcium Balance|Calcium balance is measured by dietary calcium intake (mg/d) minus calcium excretion (mg/d) (from both urine and feces).|2 weeks||||mg/d calcium||Standard Error|Least Squares Mean
1412551|NCT01161329|Primary|Short Physical Performance Battery (SPPB)|Total score on the scale: 0-12 Points. Higher scores indicates better functioning. SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.|Baseline, after 3, 6 months and after 1 year||||units on a scale||Standard Deviation|Mean
1412552|NCT01161329|Primary|The Berg Balance Scale (BBS)|Total score on the scale: 0-56 Points. Higher scores indicates better balance.|baseline, after 3, 6 months and after 1 year||||units on a scale||Standard Deviation|Mean
1412553|NCT01161225|Secondary|Health Care Utilization Events|Participants report the following information for the prior 3-month period; their emergency department visits for asthma; hospitalization for asthma; urgent office visit for worsening asthma; routine office visit; specialist visit. A cumulative number of events were computed by adding # of visits and # of days (for hospitalization) occurred in the past 3 months .|9-months postcamp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||average number of events||Standard Deviation|Mean
1412554|NCT01161225|Secondary|Forced Expiratory Volume in 1 Second (FEV1) % Predicted|Maximal amount of air one can forcefully exhale in one second. It is then converted to a percentage of normal. Range: 55-124 for the current sample.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed spirometry at 9-months assessment.|||percentage of predicted FEV1||Standard Deviation|Mean
1412555|NCT01161225|Secondary|Asthma Knowledge Questionnaire|This 30-item instrument was developed to measure children’s knowledge on triggers and symptom identifications, and asthma management procedures (i.e., what to do and how to do it) in a true/false format. Total scores (range: 14-30) were computed by summing the number of items correctly answered. The higher scores indicate greater knowledge levels.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
1412556|NCT01161225|Secondary|Attitude Toward Illness Scale|This 13-item scale was designed to assess children’s attitude toward their health condition. The scale includes questions such as “how good or bad do you feel it is that you have ___?” and, “how often do you feel that your ___ is your fault?” Respondents answer each question on a 5-point Likert-type scale (1-5). Total summed scores (range: 25-65) was constructed to reflect respondents’ overall attitudes. Higher scores indicated positive attitudes.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
1412557|NCT01161225|Secondary|Illness Management Survey|This 29-item scale was developed to assess perception of barriers and to predict risk for poor self-management in adolescents with chronic illness. This scale categorizes barriers based on internal processes (e.g., cognitive skills, denial, pessimistic thinking) and contextual forces (e.g., illness-related factors, peer/family influences). Total summed scores were computed (range: 28-91). Higher scores indicate the high levels of perceived barriers to self-management.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
1412558|NCT01161225|Secondary|Asthma Self-Efficacy|This 14-item scale was developed to measure the child’s confidence in attack prevention (e.g., learn asthma self-management skills, correct use of medication) and attack management (e.g., control symptoms, decide which medication to use). Total summed scores were computed (range: 21-70). Higher total scores indicate greater degree of self-efficacy.|9 months post camp|the number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
1412609|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Day 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Day 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412560|NCT01161225|Primary|Pediatric Asthma Quality of Life Questionnaire (PAQLQ)|Twenty-three items cover problems identified as being most important and troublesome in children’s everyday lives due to asthma. This scale is effective in evaluating and discriminating because of its high sensitivity to changes in asthma status within and between individuals with varying severity of asthma. Respondents are asked to recall impairments experienced during the previous week. The scale consists of three subdomains including symptoms (10 items), emotional function (8 items) and activity limitation (5 items). Each item was measured on a 7-point scale; 1 indicates maximum impairment, and 7 indicates no impairment. Higher total scores indicate better levels of functioning. Total scores were computed by summing responses from all items (range:24-161)|9 months post camp|The number of participants analyzed includes only those who stayed in the study and completed the 9-months assessment.|||units on a scale||Standard Deviation|Mean
1412561|NCT01161173|Secondary|Percentage of Participants Who Developed Rash|At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.|||Percentage of participants||95% Confidence Interval|Number
1412562|NCT01161173|Secondary|Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores|Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with LCSS scores were included in the analysis.|||Units on a scale||95% Confidence Interval|Mean
1412563|NCT01161173|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until or death from any cause|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.|||Months||95% Confidence Interval|Median
1412564|NCT01161173|Secondary|Progression-free Survival|Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Months||95% Confidence Interval|Median
1412565|NCT01161173|Secondary|Time to Disease Progression|The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Months||95% Confidence Interval|Median
1412566|NCT01161173|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was “confirmed” if a subsequent RECIST evaluation also showed a CR or PR.|Baseline to the end of the study (up to 4 years, 4 months)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1412567|NCT01161160|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412610|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 12|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412569|NCT01161160|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412570|NCT01161160|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 21-day (Days 0-20) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412571|NCT01161160|Secondary|Number of Subjects With pIMDs|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412572|NCT01161160|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Up to Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412573|NCT01161160|Secondary|Number of Subjects With MAEs|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|During the entire study period (Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412574|NCT01161160|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|Up to day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412575|NCT01161160|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom= symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C, but ≤ 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 6 to 10 years.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 6 to 10 years who received the study vaccine.|||Participants|||Count of Participants
1412576|NCT01161160|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C or > 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects aged 3 to 5 years who received the study vaccine.|||Participants|||Count of Participants
1412577|NCT01161160|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to < 10 years= pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
1412578|NCT01161160|Secondary|HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain|Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1412611|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 8|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1413854|NCT01150474|Primary|Pain at Hour 4|"Pain at 4 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|4 hours following surgery||||units on a scale||Standard Deviation|Mean
1412579|NCT01161160|Secondary|Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value|The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Participants|||Count of Participants
1412580|NCT01161160|Secondary|HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain|Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1412581|NCT01161160|Secondary|Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value|The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1412582|NCT01161160|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was > 2.5.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1412583|NCT01161160|Secondary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Participants|||Count of Participants
1412584|NCT01161160|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was > 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was > 40%.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.|||Participants|||Count of Participants
1412585|NCT01161160|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was > 2.5.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1412586|NCT01161160|Primary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjeects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1412587|NCT01161160|Primary|Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1412612|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 4|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412613|NCT01160822|Secondary|Patient's Global Assessment of Response to Treatment at Week 2|Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412588|NCT01161160|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was > 40%.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1412589|NCT01161121|Secondary|Side Effects of Medication Administration|Chest pain, chest discomfort, burning, flushing, headache, nausea, or shortness of breath|During drug infusion and until restoration of baseline hemodynamics||||participants|||Number
1412590|NCT01161121|Secondary|Heart Rate Changes With Drug|Maximal heart rate documented following the administration of each agent|During drug infusion and until restoration of baseline hemodynamics||||beats per minute||Standard Deviation|Mean
1412591|NCT01161121|Primary|Difference in FFR Between IV Adenosine and IV Regadenoson|FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson|At maximal, steady-state hyperemia|Per protocol|||ratio (Pd/Pa)||Standard Deviation|Mean
1412592|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|24 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
1412593|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|12 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
1412594|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|8 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
1412595|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 2, measured by in vivo fluorescence spectroscopy|3 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
1412596|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|3 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
1412597|NCT01160848|Primary|Photoactive Porphyrins Level|Photoactive porphyrins levels on the skin surface of acne patients, part 1, measured by in vivo fluorescence spectroscopy|1.5 hours after cream application||||Fluorescence intensity unit||95% Confidence Interval|Mean
1412598|NCT01160822|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.|||mL||Standard Deviation|Mean
1412599|NCT01160822|Secondary|Apparent Clearance of Canakinumab From Plasma (CL/F)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set, where data were available.|||mL/hr||Standard Deviation|Mean
1412600|NCT01160822|Secondary|Terminal Phase Half-life (t1/2) of Canakinumab|The time it takes for the concentration level of canakinumab to fall to 50% of the original value.|Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||hours||Standard Deviation|Mean
1412601|NCT01160822|Secondary|Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||µg*day/mL||Standard Deviation|Mean
1412602|NCT01160822|Secondary|Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||µg*day/mL||Standard Deviation|Mean
1412603|NCT01160822|Secondary|Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||hours||Full Range|Median
1412604|NCT01160822|Secondary|Maximum Observed Plasma Concentration of Canakinumab (Cmax)||Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.|Pharmacokinetic analysis set where data were available.|||µg/mL||Standard Deviation|Mean
1412605|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 12|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 12|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412606|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 8|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 8|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412607|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 4|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 4|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1412608|NCT01160822|Secondary|Part B: Physician's Global Assessment of Response to Treatment at Week 2|The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.|Week 2|Pharmacodynamic analysis set, where data were available.|||participants|||Number
1413855|NCT01150461|Secondary|Percentage Change From Baseline in Left Ventricular Mass at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year||||Percentage change in LV mass||Inter-Quartile Range|Mean
1412615|NCT01160822|Secondary|Part B: Proportion of Participants Who Used Rescue Analgesic During Study|Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication.|Day 4, Weeks 1, 2, 4, 8 and 12|Safety analysis set (all participants as assigned that received at least one dose of study drug).|||proportion of participants|||Number
1412616|NCT01160822|Secondary|Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales|"The WOMAC consists of 3 subscales:~The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.~The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.~The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.~Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.|||units on a scale||Standard Deviation|Mean
1412617|NCT01160822|Secondary|Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)|A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).|Baseline, Day 4, Weeks 1, 2, 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data. N is the number of participants with available data at each time point.|||percentage of participants|||Number
1412618|NCT01160822|Secondary|Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).~Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Weeks 4, 8 and 12|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.|||units on a scale||Standard Deviation|Mean
1412619|NCT01160822|Primary|Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale|"The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.~Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects."|Baseline and Week 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.|||units on a scale||Standard Deviation|Mean
1412620|NCT01160822|Primary|Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)|"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.~Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects."|Baseline and Day 4|Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.|||units on a scale||Standard Deviation|Mean
1412621|NCT01160822|Primary|Part A: Number of Participants With Intolerance Events|An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection.|Baseline to Day 3|Safety analysis set.|||participants|||Number
1412622|NCT01160770|Secondary|Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms|"The parent/caregiver was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36||||percentage of participants|||Number
1412623|NCT01160770|Secondary|Investigator Global Evaluations of the Patient's Overall Change in Symptoms|"The physician was asked to rate the patient's overall change in symptoms since the beginning of clobazam treatment by checking very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline to month 36||||percentage of participants|||Number
1412624|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36||||percentage of participants|||Number
1412625|NCT01160770|Secondary|Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment|Number of drop seizures obtained from seizure diaries|Baseline to month 36||||percentage of participants|||Number
1446877|NCT00877929|Secondary|SBP Control 140 at Four Weeks|Mean seated SBP < 140 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
1412628|NCT01160744|Other Pre-specified|Change in Tumor Size (CTS)|CTS was defined as the log ratio of tumor size at 6 weeks to tumor size at baseline. CTS at 6 weeks=Log (Sum of Target Lesion Measurements at 6 Weeks)-Log (Sum of Target Lesion Measurements at Baseline).|Baseline, 6 weeks|All randomized participants with results at baseline and 6 weeks.|||log ratio||Standard Deviation|Mean
1412629|NCT01160744|Other Pre-specified|Percentage of Participants With CR, PR, or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.|||percentage of participants||90% Confidence Interval|Number
1412630|NCT01160744|Secondary|Squamous Population OS|OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Randomization to the date of death from any cause [up to end of study]||2018-06-30|06/2018||||
1412631|NCT01160744|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Who Died|Data presented are the number of participants with at least 1 treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (SAE), as well as, the number of participants who died during the study. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). A summary of SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Day 1, Cycle 1 (3-week cycles) up to 89 weeks of treatment and 1 month post-treatment follow-up|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1412632|NCT01160744|Secondary|Duration of Response (DOR)|DOR was measured from the time criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death. Response was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker level of non-target lesions. PR was defined as ≥30% decrease SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who did not relapse were censored at the day of their last objective tumor assessment.|Time of first response (CR or PR) until PD or death (up to 24 months)|All randomized participants with a best overall response of CR or PR. Participants censored: Pem+Carb/Cis=44, Ram+Pem+Carb/Cis=35, Gem+Carb/Cis=50, Ram+Gem+Carb/Cis=37.|||months||90% Confidence Interval|Median
1412633|NCT01160744|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Randomization to the date of death from any cause (up to 31.3 months)|ITT Population: All randomized participants. Participants censored: Pem+Carb/Cis=22, Ram+Pem+Carb/Cis=16, Gem+Carb/Cis=32, Ram+Gem+Carb/Cis=32.|||months||90% Confidence Interval|Median
1412634|NCT01160744|Secondary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in SOD of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Day 1, Cycle 1 (3-week cycles) and every 6 weeks thereafter to PD (up to 24 months)|ITT Population: All randomized participants.|||percentage of participants|||Number
1412635|NCT01160744|Primary|Progression-Free Survival (PFS)|PFS was the time from randomization to the first objective progression as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1) or death from any cause, whichever occurred first. Progressive disease (PD) was defined as ≥20% increase in sum of diameter (SOD) of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 millimeters (mm); appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants alive and without disease progression were censored at the time of the last objective tumor assessment. Participants who did not progress and were lost to follow-up were censored at their last radiographic assessment. If no baseline or post baseline radiologic assessments were available, participants were censored at date of randomization.|Randomization to PD or death (up to 24 months)|Intent-to-Treat (ITT) Population: All randomized participants. Participants censored: Pem+Carb/Cis=14, Ram+Pem+Carb/Cis=13, Gem+Carb/Cis=14, Ram+Gem+Carb/Cis=18.|||months||90% Confidence Interval|Median
1412636|NCT01160640|Secondary|Identification of Endometrial Microorganisms Present Obtained From Women With or Without Evidence of Endometritis.|Identification of endometrial microorganisms present obtained from women with or without evidence of endometritis using a combination of culture methods, rRna sequencing and whole genomic sequencing. The aim is to identify the etiology of endometritis.|enrollment|Women who had an endometrial sample that was sufficient for histologic assessment for endometritis.|||participants|||Number
1412637|NCT01160640|Secondary|Resolution of Clinical Signs and Symptoms of Acute PID - Intention to Treat Analysis|Clinical response to treatment is improvement (reduction) of the McCormack Scale total score from baseline to day 3 follow-up visit. Participants without a 3-day measure were considered treatment failures.|Enrollment to 3 day follow up visit||||participants|||Number
1412638|NCT01160640|Secondary|The Eradication of M. Genitalium From the Lower and Upper Genital Tract Following Antibiotic Therapy for Acute PID.|M. genitalium not detected in the cervical and endometrial cultures by nucleic acid amplification testing at the 30 day visit among women who had M. genitalium detected at either anatomical site at the enrollment visit.|Enrollment to 30 days|There were 34 women who had M. genitalium detected in the cervix or endometrium at enrollment who had test results from the 30-day visit.|||participants|||Number
1412639|NCT01160640|Secondary|The Prevalence of M. Genitalium in the Cervix and Endometrium From Women With Acute PID.|The number of women who had M. genitalium detected in cervical and endometrial biopsy cultures by nucleic acid amplification tests at enrollment.|enrollment||||participants|||Number
1412640|NCT01160640|Primary|Clearance of Anaerobic Organisms From the Endometrium|Clearance of anaerobic microorganisms from the endometrium at the 30 day follow-up visit among women who had anaerobic microorganisms detected in their endometrial tissue sample at enrollment. Clearance is defined as no anaerobic microorganisms detected in the endometrial tissue biopsy sample collected at the 30-day visit.|Enrollment to 30 days|Women who had anaerobic microorganisms detected in their endometrial biopsy sample at enrollment based on standard bacterial culture techniques.|||participants|||Number
1412641|NCT01160614|Primary|The Number of Patients With Adverse Events as a Measure of Safety||Adverse events (AEs) & serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion (AEs) & through 30 days following last study drug dose, or until last study visit, whichever was later (SAEs).|The safety population (N = 30) was defined as the group of patients who received study drug|||participants|||Number
1412642|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Lag Time Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value From Hour 0 to 12 Hours of the First Dose of ORF (Tlag 0-12)|Due to insufficient sampling, tlag 0-12 was not estimated.|Up to 12 hours|||||||
1412643|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Time to Maximum Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Tmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||h||Full Range|Median
1412644|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Maximum Observed Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Cmax 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng/mL||Standard Deviation|Mean
1412645|NCT01160614|Primary|Single- and Multiple-dose PK Metric: Mean Area Under the Plasma Concentration During Each Dosing Interval-time Curve From Hour 0 to 12 Hours of the First Dose of ORF (AUC 0-12)||Up to 12 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng*h/mL||Standard Deviation|Mean
1412646|NCT01160614|Primary|Single-dose PK Metric: Lag Time Was Estimated as the Time Point Immediately Prior to the First Measurable Plasma Concentration Value (Tlag)|Due to insufficient sampling, tlag was not estimated.|Up to 24 hours|||||||
1412647|NCT01160614|Primary|Single-dose PK Metric: Apparent Plasma Terminal Phase Half/Life (t1/2z)|Due to insufficient sampling, t1/2z was not estimated.|Up to 24 hours|||||||
1412648|NCT01160614|Primary|Single-dose PK Metric: Apparent Terminal Phase Rate Constant (Lamda z)|Due to insufficient sampling, Lamda z was not estimated.|Up to 24 hours|||||||
1412649|NCT01160614|Primary|Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||hour (h)||Full Range|Median
1412650|NCT01160614|Primary|Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng/mL||Standard Deviation|Mean
1412651|NCT01160614|Secondary|Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)||Up to 72 hours if all 5 doses were administered|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng/mL||Standard Deviation|Mean
1412652|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf)|Due to insufficient sampling, AUCinf was not estimated.|Up to 24 hours|||||||
1412653|NCT01160614|Primary|Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]||Up to 24 hours|The full analysis population for PK (N = 30) was defined as patients who received at least 1 dose of oral study drug and had at least 1 valid quantifiable PK metric|||ng*h/mL||Standard Deviation|Mean
1412654|NCT01160484|Secondary|Follow-up Time|time that patients were monitored for disease progression and overall survival|Follow-up visits for disease progression and overall survival every 3 months after study discontinuation. After progression, follow-up visits for survival status every 6 months or until alternate therapy needs to be started or death intervenes||||months||Full Range|Median
1412655|NCT01160484|Secondary|Progression-free Survival||Time from the start of treatment to progressive disease or until death||||months||Full Range|Median
1412656|NCT01160484|Secondary|Time to Progression||Time from the start of treatment to progressive disease||||months||Full Range|Median
1412657|NCT01160484|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.||||months||Full Range|Median
1412658|NCT01160484|Secondary|Time to Best Response||Up to 7.5 months (eight 28-day cycles)||||months||Full Range|Median
1412659|NCT01160484|Secondary|Time to First Response||Up to 7.5 months (eight 28-day cycles)||||months||Full Range|Median
1412660|NCT01160484|Primary|International Myeloma Working Group (IMWG) Response Criteria|The investigator will evaluate each patient for response to therapy according to criteria augmented from those developed by Bladé et al., 1998 presented below (Table 7-1). Assessment of disease response will be performed prior to drug administration on Day 1 of Cycles 2 8 and at the End of Study Treatment visit. If a patient is determined to have complete response (CR), very good partial response (VGPR), partial response (PR), or minor response (MR), then assessment of disease response is to be performed 4 weeks later to confirm the response.|Up to 7.5 months (eight 28-day cycles)|Population analysis was carried out as per protocol. Efficacy was evaluated via a modified version of the Bladé response criteria [complete response (CR), very good partial response (VGPR), partial response (PR), and those achieving minimal response (MR)]|||participants|||Number
1412661|NCT01160458|Secondary|Overall Survival (OS)|Overall survival is the time interval from the start of treatment to the date of death.|To study completion, an average of 3 years|One participant withdrew from the study and was excluded from the analysis.|||Months||95% Confidence Interval|Median
1412662|NCT01160458|Secondary|Progression Free Survival (PFS)|Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).|To study completion, an average of 3 years|One participant withdrew from the study and was excluded from the analysis.|||months||95% Confidence Interval|Median
1412663|NCT01160458|Secondary|Duration of Overall Response|Duration of Overall Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).|36 months|No participants had a complete response or partial response.||||||
1412664|NCT01160458|Secondary|Safety of IMC-A12 in Patients With Mesothelioma|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 36 months||||Participants|||Count of Participants
1412665|NCT01160458|Primary|Clinical Response Rate (PR+CR)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|36 months||||Participants|||Count of Participants
1412666|NCT01160445|Secondary|Toxicity of Zanolimumab and IL-2 Treatment Regimen|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10 months||||Participants|||Number
1412667|NCT01160445|Primary|The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.|Tumor regression was assessed by the Response Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% in the sum of the longest diameter (LD) recorded since the treatment started. Stable disease (SD) is neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|2 years||||Participants|||Number
1412668|NCT01160380|Secondary|Epworth Sleepiness Scale (ESS) Score|Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness|Day 1, Day 28 and Day 56||||units on a scale||Standard Deviation|Mean
1412669|NCT01160380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.|Day 1, Day 28 and Day 56||||units on a scale||Standard Error|Mean
1412670|NCT01160380|Secondary|Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score|Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).|Day 1, Day 28 and Day 56||||units on a scale||Standard Deviation|Mean
1412671|NCT01160380|Primary|Digit Span Test Score|Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.|Day 1, Day 28 and Day 56||||Number of correct items||Standard Deviation|Mean
1412672|NCT01160380|Primary|Symbol Digit Modalities Test Score (SDMT)|Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance|Day 1, Day 28 and Day 56||||Number of correct matches||Standard Deviation|Mean
1412673|NCT01160380|Primary|Trail Making Test B Score (TMT-B)|"Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.~The test evaluates the time to correctly order letters and numbers; low times = better performance."|Day 1, Day 28 and Day 56||||seconds||Standard Deviation|Mean
1412678|NCT01160237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events||During 31 days (Day 0 - Day 30) after vaccination|The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.|||subjects|||Number
1412679|NCT01160237|Secondary|Solicited Local and General Symptoms||During 7 days (Day 0 - Day 6) after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1412680|NCT01160237|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years||21 days after vaccination|This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.||||||
1412681|NCT01160198|Secondary|Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate|The comparison in percentage of participants with gastrointestinal side effects during 8 week treatment period is reported. Gastrointestinal side effects during 8 weeks treatment included abdominal discomfort, gastritis, nausea, dyspepsia, change in bowel habit, constipation, faeces discolored, diarrhea and flatulence.|Up to Week 8|Intent to treat (ITT) population which comprised of all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1412682|NCT01160198|Secondary|Mean Change in Hb During 8 Weeks Therapy|At fortnightly visits, blood was collected for Hb. Mean change in Hb at Week 2, Week 4, Week 6 and Week 8 are presented.|Up to Week 8|PP population. Only those participants available at the specified time points were analyzed.|||gm/dL||95% Confidence Interval|Mean
1412683|NCT01160198|Secondary|Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment|At fortnightly visits, blood was collected for Hb. Number of participants who achieved a target Hb of more than or equal to 12 gm/dL is presented.|Up to Week 8|PP population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1412684|NCT01160198|Secondary|Mean Change in Hb From Baseline to 8 Weeks|At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline to Week 8|PP population. Only those participants with data available at the indicated time points were analyzed.|||gm/dL||95% Confidence Interval|Mean
1412685|NCT01160198|Primary|Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily)|At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline and Week 8|Per protocol (PP) population.|||Gram per deciliter (gm/dL)||95% Confidence Interval|Mean
1412686|NCT01159938|Secondary|Change in Postprandial Pulse Wave Velocity (PWV)|The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and post-baseline PWV measurement at specified time point and no major protocol deviation.|||meters per second (m/sec)||Standard Deviation|Mean
1412687|NCT01159938|Secondary|Change in Blood Glucose (BG)|Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline blood glucose measurement at specified time point and no major protocol deviation.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1412688|NCT01159938|Secondary|Change in QT Interval on Electrocardiogram (ECG)|QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline QT interval measurement at specified time point and no major protocol deviation.|||milliseconds (msec)||Standard Deviation|Mean
1412689|NCT01159938|Secondary|Change in Peripheral Artery Tonometry (PAT)|The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)|Enrolled healthy and randomized T2DM participants who had a baseline and a post-baseline PAT measurement at specified time point and no major protocol deviation.|||percentage of pulse amplitude||Standard Deviation|Mean
1412690|NCT01159938|Secondary|Change in Pulse Wave Amplitude (PWA)|The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported.|30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)|Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants with a baseline and a post-baseline PWA measurement at specified time point and no major protocol deviation.|||percentage of systolic peak||Standard Deviation|Mean
1412691|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|240 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
1413226|NCT01154452|Primary|Maximum-tolerated Dose of Gamma-secretase Inhibitor RO4929097, Defined as the Dose Level Where no More Than 1 Out of 6 Patients Experience DLT at the Highest Dose Level Below the MAD, Graded According to NCI-CTCAE Version 4.0 (Phase Ib)||Up to 28 days||||mg|||Number
1412692|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|180 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
1412693|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|120 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
1412694|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|60 mins (post-breakfast)|Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/sec)||95% Confidence Interval|Least Squares Mean
1412695|NCT01159938|Primary|Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast|The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|30 mins (pre-breakfast)|Randomized T2DM participants who were scheduled to receive study drug and had a baseline PWV measurement at the specified time point and no major protocol deviation.|||meters per second (m/s)||95% Confidence Interval|Least Squares Mean
1412696|NCT01159912|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the ages of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
1412697|NCT01159912|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
1412698|NCT01159912|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1412707|NCT01159743|Primary|Total Limb Fat Mass|Total limb fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan. DEXA uses a whole body scanner and two different low-dose x-rays to read bone mass and soft tissue mass.|Study visit|All participants for whom data were available.|||kg||Standard Deviation|Mean
1412708|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3|"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied."|At Visit 3 (after approximately 6 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.|||participants|||Number
1413856|NCT01150461|Primary|Percentage Change From Baseline in Extent of Left Ventricular Fibrosis at 1 Year as Assessed by Magnetic Resonance Imaging.||Baseline and 1 year||||Percentage change in fibrotic myocardium||Standard Deviation|Mean
1412699|NCT01159912|Secondary|Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough evening PEF is the PM PEF measured approximately 24 hours after the last evening administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1412700|NCT01159912|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
1412701|NCT01159912|Primary|Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
1412702|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied were you with olopatadine 0.2%? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 7|All subjects who used the study medication at least once (intent to treat).|||Percentage of Participants|||Number
1412703|NCT01159769|Primary|Overall Patient Satisfaction|"Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, Overall, how satisfied are you with your current eye allergy medication? A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, very satisfied or satisfied."|Day 0|All subjects who used the study medication at least once (intent to treat).|||Percentage of Participants|||Number
1412704|NCT01159743|Secondary|Change Over Time in Body Fat Distribution|"Change over time in total body fat and fat in the limbs and trunk was assessed by dual X-ray absorptiometry (DEXA) in participants for whom a DEXA measurement performed at least 6 months before participation in this study was available.~A negative change score indicates fat loss over time and a positive change score indicates fat gain over time."|DEXA performed at the study visit and more than 6 months prior to the study visit (the period of time between the DEXA recorded at the study visit and the previous DEXA ranged from 6 to 36 months).|Participants for whom a dual X-ray absorptiometry measurement performed at least 6 months before participation in this study was available.|||kg||Standard Deviation|Mean
1412705|NCT01159743|Secondary|Lipodystrophy Severity Grading Scale (LSGS) Scores|"Perception of body fat was assessed by the Lipodystrophy Severity Grading Scale (LSGS), a standardized measurement of subjective lipoatrophy (fat loss) and lipoaccumulation (fat gain) perceived by the participant and by the physician. The degree of lipoatrophy and diffuse fat accumulation at each region was rated by both the participant and the physician as: Score 0=absent; Score 1=mild or noticeable on close inspection; Score 2=moderate or readily noticeable by patient/physician; Score 3=severe or readily noticeable to a casual observer.~Score A reflects the lipoatrophy or fat loss perception at the face, arms, buttocks and legs and ranges from 0-12.~Score B reflects the perception of fat gain at the abdomen, neck, and breasts and ranges from 0-9.~The overall score is the sum of the scores A+B, and ranges from 0-21.~Higher numbers indicate more fat loss (Score A) or gain (Score B). An average overall patient/physician score >7 indicates a clinical diagnosis of lipodystrophy."|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each score for each group of participants is shown as N (EFV and then LPV/r)."|||units on a scale||Standard Deviation|Mean
1412706|NCT01159743|Secondary|Distribution of Body Fat Mass|Body fat mass was assessed by dual energy X-ray absorptiometry (DEXA) scan.|Study visit|"All participants for whom data were available. The number of participants included in the analysis of each category for each group of participants is shown as N (EFV and then LPV/r)."|||kg||Standard Deviation|Mean
1412753|NCT01159054|Secondary|Albumin Level|Pre and Post levels.|6 months|Only 2 subjects completed the study. Further analysis was not done because power was not met.|||g/dL||Full Range|Mean
1412709|NCT01159691|Primary|Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2|"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied."|At Visit 2 (after approximately 2-4 weeks)|All of the 65 subjects in the Full Analysis Set are included in this analysis.|||participants|||Number
1412710|NCT01159691|Primary|Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints|"Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day).~For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 – 12).~Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 – 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement."|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1412711|NCT01159691|Primary|Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)|Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement.|From Baseline to Visit 3 (approximately 6 weeks)|Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis.|||millimeter (mm)||Standard Deviation|Mean
1412712|NCT01159665|Other Pre-specified|Time Necessary to Remove the Vitreous From the Eye|PPV was performed in all subjects. The time necessary to remove the vitreous from the eye, measured from first start of vitrectomy cutter till end of core vitrectomy phase, was calculated.|From first start of vitrectomy cutter till the end of core vitrectomy phase|Safety Set|||Minutes||Standard Deviation|Mean
1412713|NCT01159665|Primary|Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.|Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 [5-30 minutes]; Group 2 [31-60 minutes]; Group 3 [2-4 hours]; Group 4 [24 hours ±2 hours]; Group 5 [7 days ±1 day]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.|5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection|Safety Set. Values for the PPV 7 days (+1 day) after injection and for PPV without injection treatment groups were all < Lower Limit of Quantification (LLOQ)|||ng/mL||Standard Deviation|Mean
1412714|NCT01159600|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic events, as reported as adverse events.|From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days|"Treated set, which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.~Open label set which included all patients entered into the open-label arm."|||percentage of participants|||Number
1412715|NCT01159600|Primary|HbA1c Change From Baseline|"Change from baseline in HbA1c after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||percentage of HbA1c||Standard Error|Mean
1412716|NCT01159600|Secondary|Mean Daily Plasma Glucose (MDG) Change From Baseline|"Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||mg/dL||Standard Error|Mean
1412717|NCT01159600|Secondary|Body Weight Change From Baseline|"Body weight change from baseline after 24 weeks.~For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication."|Baseline and 24 weeks|"Full analysis set. Treatment assignment as randomised.~Open-label analysis: Open-label set which included all patients entered in the empa 25mg open-label treatment arm.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||kg||Standard Error|Mean
1412718|NCT01159574|Secondary|Time to Disease Progression (Progression Free Survival)||From start of treatment, to date of disease progression|18 patients were removed from study for reasons other then disease progression; 2 patients are still receiving treatment.|||days||Full Range|Mean
1412719|NCT01159574|Secondary|Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response||From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days||||cycles||Full Range|Mean
1412720|NCT01159574|Primary|Overall Response Rate|Best response rate was recorded for all patients, using the IMWG criteria.|from baseline to cycle with maximum response, which was achieved on average after 2 cycles||||Participants|||Count of Participants
1412721|NCT01159535|Primary|Mean Number of Alcohol and Drug Use Days Out of Past 30|Self reported use of alcohol and or illicit substances over the previous 30 days|30 days previous, assessed at 12-month follow-up||||number of days out of past 30||Standard Deviation|Mean
1412754|NCT01159054|Primary|Changes in IL-6 Level|Change in IL-6 level before and after treatment in each subject|6 months|Only 2 subjects completed the study. Further analysis not done because power was not met.|||pg/mL||Full Range|Mean
1412722|NCT01159431|Secondary|Mood|Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of > 25 consistent with severe depression.|18-weeks||||units on a scale||Standard Deviation|Mean
1412723|NCT01159431|Primary|Change in Seizure Frequency|Percent change in seizure frequency from baseline|18 weeks||||percentage change in seizures per month||Standard Deviation|Median
1412724|NCT01159431|Secondary|Response Ratio: Mean Percent Change in Seizures|Response Ratio: Mean Percent Change in seizures over the treatment period, where [T-B] / [T+B] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.|18 weeks||||percentage change of RRATIO||Standard Deviation|Mean
1412725|NCT01159431|Primary|Time to the 4th Seizure|Number of Days to the 4th seizure|treatment period (18-weeks)||||days||Standard Deviation|Mean
1412726|NCT01159431|Primary|50% Responder Rate|"Change in responder rate, at end of study (18 weeks)~Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage."|Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks||||percentage of participants|||Number
1412727|NCT01159262|Secondary|Time to Successful Extubation in DEX-exposed Subjects||From start of DEX administration to extubation of each subject up to 7 days post-infusion|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.|||hour||95% Confidence Interval|Median
1412728|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion|||milligram/Kg||Standard Deviation|Mean
1412729|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion|||microgram/Kg||Standard Deviation|Mean
1412730|NCT01159262|Secondary|Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion|||milligrams/Kg||Standard Deviation|Mean
1412731|NCT01159262|Secondary|Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received morphine during Dexmedetomidine infusion|||milligram||Standard Deviation|Mean
1412732|NCT01159262|Secondary|Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During study drug administration (6 to 24 hours)|All subjects who received fentanyl during Dexmedetomidine infusion|||Microgram||Standard Deviation|Mean
1412733|NCT01159262|Secondary|Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)||During Study drug administration (6 to 24 hours)|All subjects who received midazolam during Dexmedetomidine infusion|||Milligram||Standard Deviation|Mean
1412734|NCT01159262|Secondary|Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion||During Study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.|||percentage of subjects|||Number
1412735|NCT01159262|Primary|Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion||During study drug administration (6 to 24 hours)|Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours.|||percentage of subjects|||Number
1412736|NCT01159171|Secondary|Overall Survival|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||months||Standard Deviation|Mean
1412737|NCT01159171|Secondary|Overall Survival (OS) - Percentage of Participants With an Event by 24 Months|OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||percentage of participants|||Number
1412738|NCT01159171|Secondary|Time to Progression|TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||months||Standard Deviation|Mean
1412739|NCT01159171|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months|TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||percentage of participants|||Number
1412740|NCT01159171|Secondary|Time to Treatment Failure|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.|Baseline, monthly to end of study (up to 24 months)|ITT Population|||months||Standard Deviation|Mean
1412755|NCT01159054|Primary|Changes in Hs-CRP Level|Change in hs-CRP level before and after treatment in each subject|6 months|Only 2 subjects completed the study. Power for further analysis was not met.|||mg/L||Full Range|Mean
1414379|NCT01145898|Primary|3-year Change in OA RI|Measurement of change in ocular blood flow - ophthalmic artery resistance index|Baseline and 36 month visits||||unitless||Standard Error|Mean
1412741|NCT01159171|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months|TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).|Baseline, every month to end of treatment (up to 24 months)|ITT Population|||percentage of participants|||Number
1412742|NCT01159171|Secondary|Duration of Stable Disease|Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population: only participants with a best overall response of CR, PR, or SD were included in the analysis.|||months||Standard Deviation|Mean
1412743|NCT01159171|Primary|Percentage of Participants by Best Overall Response|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population. 5 participants were not assessed as they did not reach the 3 month time-point.|||percentage of participants|||Number
1412744|NCT01159171|Secondary|Duration of Stable Disease - Percentage of Participants With an Event by 24 Months|Duration of stable response (CR, PR, or stable disease [SD]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR, PR, or SD were included in the analysis.|||percentage of participants|||Number
1412745|NCT01159171|Secondary|Duration of Response|Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.|||months||Standard Deviation|Mean
1412746|NCT01159171|Secondary|Duration of Response - Percentage of Participants With an Event by 24 Months|Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|ITT population; only participants with a best overall response of CR or PR were included in the analysis.|||percentage of participants|||Number
1412747|NCT01159171|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.|Baseline, every 3 months to progression of disease or end of study (up to 24 months)|Intent to Treat (ITT) Population: all participants who signed the informed consent, were assigned a study patient number, and who were administered at least 1 dose of 1 study medication.|||percentage of participants|||Number
1412748|NCT01159054|Secondary|Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).|The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range)|6 months (checked monthly)||||Participants|||Number
1412749|NCT01159054|Secondary|Hemodialysis Access Stenosis/Thrombosis|Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study.||||||
1412750|NCT01159054|Secondary|Rate of Cardiovascular Events|Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected from the medical record due to early termination of the study.||||||
1412751|NCT01159054|Secondary|Hemoglobin Level|Pre and Post Levels|6 months|Only 2 subjects completed the study. Further analysis was not done because power was not met.|||g/dL||Full Range|Mean
1412752|NCT01159054|Secondary|ESA (Erythorpoietic Stimulating Agent) Dose Requirement|Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.|6 months|Data for this outcome measure was not collected.||||||
1412757|NCT01158976|Secondary|Infant's Gross Motor Skills Scaled Score|"Infants Gross Motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child well your child can move his or her body compared to a group of children within the same age range from across the United States. Subscale consists of 72 items. Child's scaled score is calculated from total raw scores.~Scaled score range: 1 - 6 'Lower scores indicate more developmental delay."|Approximately 3 months of age|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412758|NCT01158976|Secondary|Infant's Fine Motor Skills Scaled Score|"Fine motor skills subscale score from Bayley Scale for Infant Development. Determines how well a child recognizes sounds and how much a child can use his or her hands and fingers to do things compared to a group of children within the same age range from across the United States. Subscale consists of 66 items. Child's scaled score is calculated from total raw scores.~Scaled score range: 1 - 8 Lower scores indicate more developmental delay."|Approximately 3 months of age|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412759|NCT01158976|Secondary|Infant's Expressive Communication Scaled Score|"Scaled Score for Expressive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child communicates using sounds, gestures, or words compared to a group of children within the same age range from across the United States. Subscale consists of 48 items. Child'e scaled score is calculated from total raw scores.~Scaled score range: 2 - 9 Lower scores indicate more developmental delay."|At approximately 3 months of age|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412760|NCT01158976|Secondary|Infant's Receptive Communication Scaled Score|"Scaled Score on Receptive Communication subscale of Bayley Scale for Infant Development that determines how well a child recognizes sounds and how much a child understands spoken words and directions compared to a group of children within the same age range from across the United States. Subscale consists of 49 items. Child'e scaled score is calculated from total raw scores.~Scaled score range: 1 - 12 Lower scores indicate more developmental delay."|3 months old||||units on a scale||Standard Deviation|Mean
1412761|NCT01158976|Secondary|Gestational Age (GA)|Gestational Age at time of birth Total sample range: 27.60 to 41.60 weeks Below 37 considered premature Mothers typically induced after 41 weeks due to increased pregnancy risks after this time|Time of birth, total sample range: 27.60 to 41.60 weeks gestation|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||Weeks||Standard Deviation|Mean
1412762|NCT01158976|Secondary|Percentage of Infants Who Had a 1-minute Apgar Scores of 9|Percentage of infants who had a 1-minute Apgar scores of 9 Sub scores from 5 categories( Breathing effort, Heart rate, Muscle tone, Reflexes, Skin color) are added together Score range: 1-10 A higher score is better where 7,8,9 are normal|Time of birth, total sample range: 27.60 to 41.60 weeks gestation|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||percentage of infants|||Number
1412763|NCT01158976|Secondary|Infant Birth Weight|Weight of infant|Time of birth, total sample range: 27.60 to 41.60 weeks gestation|The analysis population reflects those infants of participants who received treatment and with available data for the assessment|||grams||Standard Deviation|Mean
1412764|NCT01158976|Secondary|Maternal Perceived Stress Scale Score|"Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 30 weeks gestation.~There are 10 questions in this scale and they all refer to typical life stressors.~Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress"|30 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412765|NCT01158976|Secondary|Maternal Perceived Stress Scale Score|"Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at 24 weeks gestation.~There are 10 questions in this scale and they all refer to typical life stressors.~Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress"|24 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412766|NCT01158976|Secondary|Maternal Perceived Stress Scale (PSS) Score|"Perceived stress as measured by the Perceived Stress Scale (Cohen et al, 1983) at baseline. There are 10 questions in this scale and they all refer to typical life stressors.~Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress"|Baseline: 16 - 21 weeks|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412767|NCT01158976|Secondary|Maternal Depression Symptoms|"Maternal depression symptoms at 30 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.~Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity."|30 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412768|NCT01158976|Secondary|Maternal Depression Symptoms|"Maternal depression symptoms at 24 weeks gestation as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.~Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity."|24 weeks|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1414380|NCT01145898|Primary|3-year Change in OA EDV|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
1412769|NCT01158976|Secondary|Maternal Depression Symptoms|"Maternal depression symptoms at 16 to 24 weeks gestation, as measured by the Edinburgh Postnatal Depression Scale, a 10-item measure designed to assess pre- and postnatal depression.~Maximum score: 30 Minimum score: 0 Possible Depression: 10 or greater Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity."|16-21 weeks gestation|The analysis population reflects those participants who received treatment and with available data for the assessment|||units on a scale||Standard Deviation|Mean
1412770|NCT01158976|Primary|Infant Cortisol Levels|Infant cortisol response to the Still-Face paradigm 45 mins post-stressor|4 months post-partum|The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
1412771|NCT01158976|Primary|Infant Cortisol Levels|Infant cortisol response to the Still-Face paradigm 20 minutes post-stressor|4 months post-partum|The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
1412772|NCT01158976|Primary|Infant Cortisol Levels|Infant cortisol response to the Still-Face paradigm before stressor|4 months post-partum|The analysis population reflects those infants whose mothers who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
1412773|NCT01158976|Primary|Maternal Cortisol Levels|Maternal stress regulation at 30 weeks gestation|45 minutes post stressor|The analysis population reflects those participants who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
1412774|NCT01158976|Primary|Maternal Cortisol Levels|Maternal stress regulation at 30 weeks gestation|20 minutes post-stressor|The analysis population reflects those participants who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
1412775|NCT01158976|Primary|Maternal Cortisol Levels|Maternal stress regulation at 30 weeks gestation|Baseline (pre-stressor)|The analysis population reflects those participants who received treatment and with available data for the cortisol assessment|||ug/dL||Standard Deviation|Mean
1412776|NCT01158924|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population|||units on a scale||Standard Deviation|Mean
1412777|NCT01158924|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
1412778|NCT01158924|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population|||participants|||Number
1412779|NCT01158924|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
1412780|NCT01158924|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~The Neurological Assessment at 12 months was only conducted on 13 subjects from the 1.0mg group (out of 14 total subjects) and 25 subjects from the 2.0 mg group (out of 26 total)."|||participants|||Number
1412781|NCT01158716|Secondary|ECG Evidence of Ischemia During Coronary Balloon Occlusion|ST-segment deviation as monitored during coronary balloon occlusion|During coronary balloon occlusion|||||||
1412782|NCT01158716|Secondary|Chest Pain During Coronary Balloon Occlusion|Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)|During coronary balloon occlusion|||||||
1412783|NCT01158716|Primary|Delta Cardiac Troponin I (ΔcTnI)|ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography|24 hours post PCI||||ng/mL||Inter-Quartile Range|Median
1412784|NCT01158703|Secondary|Number of Thrombotic Events|Number of thrombotic events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants|||thrombotic Events over 52Wks|||Number
1412785|NCT01158703|Secondary|Number of Myocardial Infarction Events|Number of myocardial infarction events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants|||MI Events over 52Wks|||Number
1412786|NCT01158703|Secondary|Number of Angina Events|Number of angina events with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of participants|||Angina Events over 52Wks|||Number
1412787|NCT01158703|Secondary|Number of Major Adverse Cardiovascular Events With Combination Therapy|Number of major adverse cardiovascular events(angina, any thrombotic events, and myocardial infarction) with combination therapy with aspirin and clopidogrel vs. aspirin alone|52 weeks|above is the total number of all events reported|||MACE Events over 52Wks|Participants||Number
1412788|NCT01158703|Secondary|Incidence of Bleeding Between the Two Treatment Arms||52 weeks||||BLEEDING EVENTS|||Number
1412789|NCT01158703|Primary|Incidence of More Than 50% Stenosis in Graft With Combination Therapy With Aspirin and Clopidogrel vs. Aspirin Alone|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo|52 weeks|Incidence of more than 50% stenosis in graft with combination therapy with aspirin and clopidogrel vs. aspirin and placebo|||occluded grafts|Participants||Number
1412790|NCT01158573|Primary|Ratio U Cys-LT/FeNO|Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio|sample taken over 5 minutes or less||||ratio||Standard Deviation|Mean
1412791|NCT01158573|Primary|Urine Cysteinyl Leukotriene Per Creatinine|Urine inflammatory mediators measured from a single urine sample|sample taken over 5 minutes or less||||pg/mg creatinine||Standard Deviation|Mean
1412792|NCT01158573|Primary|Exhaled Nitric Oxide (FeNO)|Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)|Observational: Two exhalations within 1 minute||||parts per billion (ppb)||Standard Deviation|Mean
1412793|NCT01158573|Primary|Plasma Leptin|Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw.|Observational: one time point from a blood draw after more than 6 hours fasting||||ng/ml||Standard Deviation|Mean
1412794|NCT01158534|Secondary|Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months|To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.|at two months from start of treatment|Patients that received treatment|||participants|||Number
1412795|NCT01158534|Secondary|Progression-free Survival|Progression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.|to progression||||months||95% Confidence Interval|Median
1412796|NCT01158534|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.|end of study|Patients who achieved at least a partial response|||months||Full Range|Median
1412797|NCT01158534|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method.|death||||months||95% Confidence Interval|Median
1412798|NCT01158534|Primary|Objective Response Rate Assessed by RECIST Criteria.|The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.|at week 4 of cycle 2 and every other cycle thereafter||||participants|||Number
1412799|NCT01158378|Secondary|Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.|Device-related surgical wound infections included all infections classified by the CEC as definitely, probably, possibly or undetermined in relation to the device.|120 days|Includes all subjects with available data that through 120 days follow-up.|||percentage of subjects|||Number
1412800|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 45 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|45 days|All subjects who received treatment with evaluable 45-day follow-up data.|||percentage of subjects||95% Confidence Interval|Number
1412801|NCT01158378|Post-Hoc|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"Post-Hoc analysis of primary composite endpoint of the safety and effectiveness of Adherus for a cranial application at 14 days. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|14 days|All subjects who received treatment with evaluable 14-day follow-up data.|||percentage of subjects||95% Confidence Interval|Number
1412818|NCT01158118|Primary|Number of Donors Requiring a Second Collection to Obtain a Minimum CD34/Kg (2 x 10^6) Necessary for Allogeneic Stem Cell Transplantation|The primary endpoint is to reduce the number of donors treated with GM-CSF who require a second collection to obtain a minimum CD34/Kg (2 x 106) necessary for allogeneic stem cell transplantation when compared to historic controls mobilized with GM-CSF or plerixafor alone. A reduction in failed first leukapheresis from 40% to less than 10% as seen with G-CSF alone would be considered clinically meaningful.|Up to 6 days||||Participants|||Count of Participants
1412819|NCT01157845|Secondary|Liver Transplantation|Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation|1 year||||participants|||Number
1412802|NCT01158378|Primary|Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site|"The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:~Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.~CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure~Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject’s pre-existing condition, during the 120-day follow-up period."|120 days|All subjects who received treatment with evaluable 120-day follow-up data.|||percentage of subjects||95% Confidence Interval|Number
1412803|NCT01158261|Primary|Specific Safety Parameters|"Incidence of graft occlusion~Incidence of adverse events potentially related to non-graft thrombotic events~Incidence of bleeding events"|Up to 4-weeks post-operatively|From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.|||participants|||Number
1412804|NCT01158222|Secondary|Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype||Day 28 of each cycle|Did not complete this analysis. Data not collected.||||||
1412805|NCT01158222|Secondary|Change in Circulating Tumor Cells||Pre-treatment, day 1, and day 28 of every cycle|Did not complete this analysis. Data not collected.||||||
1412806|NCT01158222|Primary|Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it|Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.|after 6 months of treatment (4 cycles)||||Participants|||Count of Participants
1412807|NCT01158118|Secondary|Death of Any Cause (Recipients Only)||Up to 1 year||||Participants|||Count of Participants
1412808|NCT01158118|Secondary|Relapse and Disease Progression Rate|-A patient will be considered relapsed (disease progressed) when there is a recurrence of the original malignant disease after transplantation.|Up to 1 year||||Participants|||Count of Participants
1412809|NCT01158118|Secondary|Transplant Related Mortality (Recipient Only)|Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.|100 days||||Participants|||Count of Participants
1412810|NCT01158118|Secondary|Rate of Chronic Graft vs. Host Disease (GvHD) (Recipient Only)|Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).|Day 100-1 year|6 participants are not evaluable for this outcome measure as they came off study prior to the start of chronic GvHD assessments.|||Participants|||Count of Participants
1412811|NCT01158118|Secondary|Rate of Acute Graft vs. Host Disease (GvHD) (Recipient Only)|-Incidence and severity of acute GVHD will be assessed based on the Seattle criteria. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s).|Up through Day 100|3 of the recipients received cells mobilized by 10 mcg/kg of GM-CSF and the 11 recipients received stem cells from donors mobilized with the decreased dose of 5 mcg/kg of GM-CSF.|||Participants|||Count of Participants
1412812|NCT01158118|Secondary|Kinetics of Immune Reconstitution as Measured by Time to Platelet Engraftment (Recipient Only)|-Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 20,000/ul without platelet transfusion support for 7 days.|Up to Day 180|1 recipient did not have platelet engraftment by Day 180 and is not evaluable for this outcome measure.|||days||Full Range|Median
1412813|NCT01158118|Secondary|Kinetics of Immune Reconstitution as Measured by Time to Neutrophil Engraftment (Recipient Only)|-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.|Up to Day 100||||days||Full Range|Median
1412814|NCT01158118|Secondary|Determine if Peripheral Blood Stem Cell Products Collected After Mobilization With IV Plerixafor Can be Used Safely for Hematopoietic Cell Transplantation in HLA-matched Recipients as Measured by Time to Neutrophil Engraftment (Recipient Only)|-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/ul following conditioning regimen induced nadir.|Up to Day 21||||Participants|||Count of Participants
1412815|NCT01158118|Secondary|Percentage of Donors Who Reach 5x10^6 CD34+ Cells/Kg Recipient Weight in 1 or 2 Aphereses|-The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. The percentage of donors who reach at least 5x10^6 CD34+ cells/Kg recipient weight will be analyzed for this outcome measure.|6 days|-If patients achieved ≥ 2x10^6 CD34+ cells/Kg, they were not required to go on to a second day of collection|||Participants|||Count of Participants
1412816|NCT01158118|Secondary|Number of Donors Who Mobilize ≥ 2x10^6 CD34+ Cells/Kg Recipient Weight Safely Following One or Two Aphereses|-The donor will undergo a leukapheresis procedure to process 20L of blood volume. After the procedure, the collection will be analyzed to look at CD34+ cell content. If it contains at least 2x10^6 CD34+ cells/kg, then the procedure will be considered successful.|Up to 6 days||||Participants|||Count of Participants
1412817|NCT01158118|Secondary|Proportion of Donors Who Experience Grade 3-4 Infusion Toxicity|Infusional toxicity will be evaluated by measuring the patient’s blood pressure, heart rate, respirations and temperature one hour prior to the allograft infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours, and 6 hours post infusion. Donors will have vital signs collected at each time point. EKGs will be performed immediately prior to IV AMD3100 and one hour after infusion.|30 days after completion of therapy (estimated to be 36 days)||||Participants|||Count of Participants
1412820|NCT01157845|Primary|Mortality From Liver Failure|Patient dies of liver-related causes within 1 year of study entry|1 year||||participants|||Number
1414381|NCT01145898|Primary|3-year Change in OA PSV|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
1412821|NCT01157533|Primary|Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose|Peak level (PK blood samples) drawn 4 hours after the completion of loading dose. Sequential trough levels drawn 30 minutes before each standard vancomycin dose for the next 4 doses. PK testing measures the amount of study drug in the body at different time points, with trough testing following 5 doses (1 dose every 8 to 12 hours).|Up to 5 days|Unable to complete analysis planned due to low enrollment.||||||
1412822|NCT01157429|Primary|Child PTSD Symptom Scale (CPSS)|The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).|After 12 therapy sessions, up to 28 weeks.||||units on a scale||Standard Deviation|Mean
1412823|NCT01157416|Primary|Child PTSD Symptom Scale (CPSS)|The CPSS is a 17-item standardized, self-administered questionnaires with versions for both youths and caregivers. Items are scored on 0-3 scale. Minimum possible score is 0 and maximum is 51. Only the total score is used; there are no subscales. A higher score indicates greater symptom severity (worse).|After 12 therapy sessions, up to 28 weeks.||||units on a scale||Standard Deviation|Mean
1412824|NCT01157377|Primary|Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes|The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).|Baseline, Week 12|Modified Intent-to-treat population included all randomized participants who received study medication and had post-baseline data available for micturition episodes.|||Episodes||Standard Deviation|Mean
1412825|NCT01157351|Primary|Percentage of Participants in Each Event Category of First Treatment Failure|First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||percentage of participants|||Number
1412826|NCT01157351|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration|The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
1412827|NCT01157351|Secondary|Time to First Psychiatric Hospitalization|A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the “Assessment of Treatment Failure – Psychiatric Hospitalization.”|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||Days||95% Confidence Interval|Median
1412828|NCT01157351|Secondary|Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration|The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants’ degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision.|Baseline up to Month 15|eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
1412829|NCT01157351|Secondary|Time to First Psychiatric Hospitalization or Arrest/Incarceration|A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant’s clinically significant worsening of symptoms of schizophrenia.|From date of randomization up to Month 15|eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||Days||95% Confidence Interval|Median
1412844|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412845|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412830|NCT01157351|Primary|Time to First Treatment Failure|Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.|From date of randomization up to Month 15|Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days’ supply + 1 day.|||Days||95% Confidence Interval|Median
1412831|NCT01157234|Secondary|Plasma Arginine (ARG) Level Change From Baseline to Month-12 Between Groups|Percent change in plasma Arginine (umol/L)=[month-12 plasma Arginine level minus baseline plasma Arginine level] divided by [baseline plasma Arginine level] multiplied by 100, where all levels are in umol/L|Baseline, Month-12|Technical limitations constrained measurements of plasma Arginine, resulting in no analysis for this outcome.||||||
1412832|NCT01157234|Secondary|Plasma Asymmetric Dimethylarginine (ADMA) Change From Baseline to Month 12 Between the Groups|Percent change in plasma ADMA (umol/L)=[month-12 plasma ADMA level minus baseline plasma ADMA level] divided by [baseline plasma ADMA level] multiplied by 100, where all levels are in umol/L.|Baseline, Month-12|Technical limitations constrained measurements of Asymmetric Dimethylarginine (ADMA), resulting in no analysis for this outcome.||||||
1412833|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Metoprolol in Transplant Recipients Age >/= 50 Years Old.||Change in Baseline, Month-12||||percent change||Standard Error|Least Squares Mean
1412834|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-twelve of Treatment With Nebivolol in Transplant Recipients >/= 50 Years Old Compared With Nebivolol in Transplant Recipients < 50 Years Old.||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.|||percent change||Standard Error|Least Squares Mean
1412835|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients < 50 Years Old Compared With Metoprolol in Transplant Recipients < 50 Years Old||Change in Baseline, Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.|||percent change||Standard Error|Least Squares Mean
1412836|NCT01157234|Post-Hoc|Percent Change in Plasma Nitric Oxide Level From Baseline to Month-12 of Treatment With Nebivolol in Transplant Recipients <50 Years Old Compared With Metoprolol in Transplant Recipients >/= 50 Years Old.||Baseline and Month-12|Nebivolol and metoprolol groups were subdivided into <50 years old and >50 years old subgroups and differences between subgroups were analyzed.|||percent change||Standard Error|Least Squares Mean
1412837|NCT01157234|Other Pre-specified|Plasma Nitric Oxide Level (Nmol/L) at Month-12 Between the Groups.||12 Months|Full analysis set included all participants who signed inform consent and received at least one dose of study drug|||nmol/L||Standard Error|Least Squares Mean
1412838|NCT01157234|Secondary|Number of Antihypertensive Drug Classes Change From Baseline to Month-12 Between the Groups.|Percent change in quantity of Anti-Hypertensive Drug Classes (AHDC)=[Month-12 absolute number of AHDC minus baseline absolute number of AHDC] divided by [baseline absolute number of AHDC] multiplied by 100.|Change in Baseline, Month-12|Percent change|||percent change||Standard Error|Least Squares Mean
1412839|NCT01157234|Secondary|Mean Arterial Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|"Absolute change in Mean Arterial Blood Pressure, (MAP), (millimeter, Mercury= Month-12 sitting trough MAP minus baseline sitting trough MAP.~Mean Arterial Pressure= 2/3 trough diastolic blood pressure + 1/3 trough systolic blood pressure"|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||millimeter, Mercury||Standard Error|Least Squares Mean
1412840|NCT01157234|Secondary|Diastolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups|Absolute Change in Diastolic Blood Pressure (DBP), (millimeter, Mercury)= Month-12 sitting trough Diastolic Blood Pressure (millimeter, Mercury) level minus baseline sitting trough Diastolic Blood Pressure (millimeter, Mercury).|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||millimeter, mercury||Standard Error|Least Squares Mean
1412841|NCT01157234|Secondary|Systolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 of Treatment Between the Groups|Absolute change in Systolic Blood Pressure (SBP), (millimeter, Mercury)=Month-12 sitting trough SBP level minus baseline sitting trough SBP level|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||millimeter, Mercury||Standard Error|Least Squares Mean
1412842|NCT01157234|Secondary|Estimated Glomerular Filtration Rate (ml/Minute) Change From Baseline to Month-12 Between the Groups|The changed percentage in Estimated Glomerular Filtration Rate (eGFR), (based on the Modification of Diet in Renal Disease Equation)=[Month-12 GFR level minus baseline eGFR level] divided by [baseline eGFR level] multiplied by 100, where all levels are in ml/min.|Change in Baseline, Month-12|Full analysis set included all participants who signed inform consent and received at least one dose of study drug.|||percent change||Standard Error|Least Squares Mean
1412843|NCT01157234|Primary|Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups.|Percent change in Nitric Oxide (NO) blood level (nmol/L)=[Month-12 NO blood level minus baseline NO blood level] divided by [baseline NO blood level] multiplied by 100, where all levels are in nmol/L.|Change in Baseline, Month-12|Full analysis set included all participants who signed informed consent and received at least one dose of study drug.|||percent change||Standard Error|Least Squares Mean
1414535|NCT01144052|Secondary|Number of Patients With Adverse Events|Recording and reporting according to regulations. Monthly assessments or if necessary.|12 months|All patients enrolled and randomized were analyzed.|||participants|||Number
1412846|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1412847|NCT01157182|Secondary|AUC0-inf for Corrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412848|NCT01157182|Secondary|AUC0-t for Corrected Unconjugated Estradiol.(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412849|NCT01157182|Secondary|Cmax for Corrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Corrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1412850|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412851|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412852|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1412853|NCT01157182|Secondary|AUC0-inf for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412854|NCT01157182|Secondary|AUC0-t for Uncorrected Unconjugated Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412855|NCT01157182|Secondary|Cmax for Uncorrected Unconjugated Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1412856|NCT01157182|Secondary|AUC0-inf for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412857|NCT01157182|Secondary|AUC0-t for Uncorrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412858|NCT01157182|Secondary|Cmax for Uncorrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for Uncorrected Total Estrone.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1412859|NCT01157182|Primary|AUC0-inf for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Corrected Total Estrone AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412860|NCT01157182|Primary|AUC0-t for Corrected Total Estrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Corrected Total Estrone AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1412861|NCT01157182|Primary|Cmax for Corrected Total Estrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Corrected Total Estrone Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1412862|NCT01157182|Primary|AUC0-inf for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Norethindrone AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1412863|NCT01157182|Primary|AUC0-t for Norethindrone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Norethindrone AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1412864|NCT01157182|Primary|Cmax for Norethindrone(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Norethindrone Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1412865|NCT01157169|Secondary|AUC0-inf for Norbuprenorphine.|Informational comparison of AUC0-inf (area under the concentration-time curve from time zero to infinity) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1412866|NCT01157169|Secondary|AUC0-t for Norbuprenorphine.|Informational comparison of AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1412867|NCT01157169|Secondary|Cmax for Norbuprenorphine.|Informational comparison of Cmax (maximum observed concentration of drug substance in plasma) values for the metabolite Norbuprenorphine.|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1412868|NCT01157169|Primary|AUC0-inf for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1412869|NCT01157169|Primary|AUC0-t for Buprenorphine.|Bioequivalence based on Buprenorphine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1412870|NCT01157169|Primary|Cmax of Buprenorphine.|Bioequivalence based on Buprenorphine Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 144 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1412871|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 38 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 38 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.|||percentage of CD63+ basophils||Full Range|Median
1412872|NCT01157117|Secondary|Change in Percent of Cells Positive for Cluster of Differentiation 63 (CD63) at Month 32 in Basophils Stimulated by Milk|Basophil cells isolated from blood using flow cytometry were stimulated with 5 different levels of milk and the percent of basophil cells that were CD63 positive was measured. The value for each participant obtained at Month 32 was subtracted from the value for that participant at baseline. The 5 different levels of milk stimulant were: 10 µg/mL, 1 µg/mL , 0.1 µg/mL , 0.01 µg/mL , and 0.001 µg/mL. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.|||percentage of CD63+ basophils||Full Range|Median
1412873|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.|||mgA/L||Full Range|Median
1412874|NCT01157117|Secondary|Change From Baseline to Month 38 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 38 was 6 months after treatment ended at Month 32.|Month 38|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 38 visit, and for whom valid results were reported.|||kUA/L||Full Range|Median
1412875|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin G4 (IgG4)|Casein and beta-lactoglobulin milk proteins IgG4 levels were measured in plasma. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.|||mgA/L||Full Range|Median
1412876|NCT01157117|Secondary|Change From Baseline to Month 32 in Antigen-specific Immunoglobulin E (IgE)|The level of milk IgE in plasma as well as the IgE levels of 2 milk proteins, casein and beta-lactoglobulin, were measured. The value for each participant was subtracted from the value for that participant at baseline. Month 32 was the last visit on treatment.|Month 32|All randomized participants and untreated controls who had not withdrawn from the study, came to the clinic for their Month 32 visit, and for whom valid results were reported.|||kUA/L||Full Range|Median
1412877|NCT01157117|Secondary|Change From Baseline to Month 32 in Area Under the Curve for Milk Endpoint Titration Prick Skin Test|A milk endpoint titration is a prick skin test using 5 serial 10-fold dilutions of milk which include 1:20 wt/vol, 1:200 wt/vol, 1:2,000 wt/vol, 1:20,000 wt/vol and 1:200,000 wt/vol. The score for each of these dilutions is calculated by subtracting the diameter of the saline control wheal from the diameter of the milk wheal (in millimeters). The area under the curve is calculated by adding together the scores from all 5 milk dilutions creating a composite score.|Month 32|All randomized participants who had not withdrawn from the study and came to the clinic for their Month 32 visit were assessed.|||units on a scale||Full Range|Median
1412878|NCT01157117|Secondary|Time to Maximum Tolerated Dose|Time to reach the maximum tolerated dose (MTD) of milk oral immunotherapy (OIT); MTD is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Time to maximum tolerated dose could not be calculated because the maximum dose for the protocol was changed part way through the study after some subjects had already reached the maximum dose.||||||
1412879|NCT01157117|Secondary|Percentage of Participants in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Desensitization to Milk|Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were counted as successes.|Month 28|Participants who received any study treatment|||percentage of participants|||Number
1412880|NCT01157117|Secondary|Maximum Tolerated Dose of Milk Oral Immunotherapy (OIT)|Maximum tolerated dose of milk OIT is the highest dose of milk powder the participant was able to consume for at least 14 consecutive days.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing|||mg milk powder||Standard Deviation|Mean
1412881|NCT01157117|Secondary|Incidence of Severe Hypersensitivity Reactions to Milk OIT|Participants who had a change in mental status or hypotension as a milk OIT dosing symptom were counted as having a severe hypersensitivity reaction.|Through completion of milk OIT dosing (at Month 28 if failed desensitization OFC, at Month 30 if passed desensitization OFC)|Participants who received milk OIT dosing.|||percentage of participants|||Number
1412882|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Maintenance Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Maintenance Phase.|After completion of Escalation Phase at 22 to 40 weeks, the Maintenance Phase lasted up to Month 30|Participants who received milk OIT dosing during the Maintenance Phase.|||percentage of participants|||Number
1412883|NCT01157117|Secondary|Incidence of Dosing Reactions to Milk OIT During the Escalation Phase|Any reaction to daily milk OIT dosing recorded by the participant during the Escalation Phase.|Baseline to completion of Escalation Phase at 22 to 40 weeks|Participants who received any milk OIT dosing during the Escalation Phase.|||percentage of participants|||Number
1412884|NCT01157117|Primary|Percentage of Subjects in the Xolair® (Omalizumab) Group vs. Placebo Group Developing Clinical Tolerance to Milk|Tolerance Assessment: Participants who successfully consumed without dose-limiting symptoms 10,000 mg of milk protein during a double-blind placebo-controlled oral food challenge were then given an open feeding of milk and those who successfully consumed the open feeding were counted as successes.|Month 32 which is 8 weeks following the discontinuation of milk OIT for both groups and 4 months after discontinuation of omalizumab for the omalizumab group|The intention to treat (ITT) population was used which included all subjects randomized to double-blind treatment.|||Percent of participants|||Number
1412885|NCT01157078|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412886|NCT01157078|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11-point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412887|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.~The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412888|NCT01157078|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15|"The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life.~The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412889|NCT01157078|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412907|NCT01157065|Primary|Incidence of Events of Special Interest (ESI)|An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.|Up to Day 30|Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit|||events|||Number
1412890|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412891|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412892|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412893|NCT01157078|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412894|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412895|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412896|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412897|NCT01157078|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|"A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412898|NCT01157078|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1414806|NCT01141569|Secondary|Tumor Control Rate (CR + PR + SD)|Tumor control rate is defined as the sum of objective response rate (CR+PR) and stable disease (SD) rate.|Up to 12 months||||Participants|||Count of Participants
1412899|NCT01157078|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412900|NCT01157078|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412901|NCT01157078|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1412902|NCT01157078|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
1412903|NCT01157078|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1412904|NCT01157078|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1412905|NCT01157078|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~MADRS is 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1412906|NCT01157078|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1412946|NCT01156571|Secondary|Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)|CEC-adjudicated results (mITT population)|48 hours after randomization||||participants|||Number
1446878|NCT00877929|Secondary|SBP Control 140 at Six Weeks|Mean seated SBP < 140 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
1412908|NCT01157065|Primary|Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4|The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.|Week 4|All patients who received study medication, completed at least one scheduled post-injection study visit, and did not receive standard therapy prior to Week 4 assessment|||microns||Standard Deviation|Mean
1412909|NCT01156987|Primary|Lesions|Number of lesions detected|at time of read by two radiologiests, compared to biopsy within 7 days.||||lesions|||Number
1412910|NCT01156844|Secondary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 12 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
1412911|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0 to 48 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
1412912|NCT01156844|Primary|Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline, 0-24 hours post dose week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
1412913|NCT01156844|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.|Baseline to week 2|Pharmacodynamic (PD) Analysis Set included all randomized participants who received at least one dose of study drug and who had evaluable PD data.|||Liters||90% Confidence Interval|Least Squares Mean
1412914|NCT01156792|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period|Participants were withdrawn if they met any of the following three criteria for ‘lack of efficacy’: 1) Clinic FEV1 below the FEV1 ‘Stability Limit’ value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF ‘Stability Limit’ for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher’s Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included.|Week 4 to Week 6|ITT Population.|||Number of participants|||Number
1412915|NCT01156792|Secondary|Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period|Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of nights||Standard Error|Least Squares Mean
1412916|NCT01156792|Secondary|Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period|Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used (“rescue-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of nights||Standard Error|Least Squares Mean
1412947|NCT01156571|Primary|The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)|Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)|48 hours after randomization||||participants|||Number
1413857|NCT01150409|Primary|Incidence of Hypotension Between Study Days 8 and 14 (Within 7 Days of the Initiation of Study Drug).|Study screening/enrollment stopped due to lack of eligible subjects. No outcome measures were analyzed due to the low enrollment.|Day 14|||||||
1412917|NCT01156792|Secondary|Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period|Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used (“rescue-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
1412918|NCT01156792|Secondary|Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period|Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from ‘0’ (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced (“symptom-free nights”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of nights||Standard Error|Least Squares Mean
1412919|NCT01156792|Secondary|Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period|Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from ‘0’ (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced (“symptom-free days”) during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
1412920|NCT01156792|Secondary|Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period|A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Number of inhalations||Standard Error|Least Squares Mean
1412921|NCT01156792|Secondary|Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period|Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from ‘0’ (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1412922|NCT01156792|Secondary|Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||L/min||Standard Error|Least Squares Mean
1412923|NCT01156792|Secondary|Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||L/min||Standard Error|Least Squares Mean
1412924|NCT01156792|Secondary|Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period|The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.|Week 4 to Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1413731|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1412925|NCT01156792|Primary|Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant’s last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.|End of Week 6|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
1412926|NCT01156701|Other Pre-specified|Number of Participants Experiencing Hospitalization or Death Due to Influenza|The frequency of hospitalization and death in the study population was analyzed.|Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
1412927|NCT01156701|Other Pre-specified|Number of Patients With Respiratory Outcomes||Baseline|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
1412928|NCT01156701|Secondary|Number of Patients With Any Respiratory Diagnosis|The frequency of any respiratory diagnosis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
1412929|NCT01156701|Secondary|Number of Patients With Bronchitis|The frequency of bronchitis among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
1412930|NCT01156701|Secondary|Number of Patients With Pneumonia|The frequency of pneumonia among the four cohorts was measured..|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
1412931|NCT01156701|Secondary|Number of Patients With Asthma|The frequency of asthma among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
1412932|NCT01156701|Primary|Number of Patients With Influenza|The frequency of influenza among the four cohorts was measured.|2006-2009|The study population consisted of individuals who were at least 5 years old and had been continuously enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009 (October-April).|||patients|||Number
1412933|NCT01156675|Secondary|Change of Quality of Life|Change in mental or physical composite score of the short form SF36|24 months|The short form SF36 was administered to study patients; however, we do not have the proprietary scoring system. Hence the scores could not be calculated.||||||
1412934|NCT01156675|Secondary|Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months|The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with “no pain” on the left border and “as severe as it could be” on the right border. The subject is instructed to make a mark along the line to represent the intensity of left leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||millimeters||Standard Deviation|Mean
1412935|NCT01156675|Secondary|Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months|The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with “no pain” on the left border and “as severe as it could be” on the right border. The subject is instructed to make a mark along the line to represent the intensity of right leg pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to eleven less subjects having VAS data at 24 months in the FLEXUS arm and four less subject with VAS data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||millimeters||Standard Deviation|Mean
1412936|NCT01156675|Secondary|Mean Visual Analog Scale (VAS) - Back Pain at 24 Months|The visual analog scale (VAS) is a questionnaire used to quantify a subjective experience, such as the intensity of pain. The scale is a 100mm line labeled with “no pain” on the left border and “as severe as it could be” on the right border. The subject is instructed to make a mark along the line to represent the intensity of back pain currently being experienced; 0mm is equal to no pain and 100mm is pain as severe as it could be. The clinician records the distance of the mark in millimeters from the left end of the scale.|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||millimeters||Standard Deviation|Mean
1418878|NCT01108003|Secondary|Apoptosis, Cell Proliferation, and Microvessel Density||1 year|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
1412937|NCT01156675|Secondary|Mean Oswestry Disability Index (ODI) at 24 Months|The Oswestry Disability Index (ODI) questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The subject chooses the statement which most closely resembles their situation. Each question is scored on a scale of 0–5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. Scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability.|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to ten less subjects having ODI data at 24 months in the FLEXUS arm and four less subject with ODI data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||score||Standard Deviation|Mean
1412938|NCT01156675|Primary|Number of Participants With an Absence of Implant-related Complications|"Absence of implant-related complications, including device dislodgement, defined as:~Failure of implant material (e.g. fracture);~Implant migration outside of the interspinous space (posteriorly beyond the posterior margin of the spinous processes, anteriorly within the spinal canal, or laterally more than half of the implant width); or~Other complications that can be specifically associated with the implanted device."|24 months|"The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arms. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
1412939|NCT01156675|Primary|Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated|Measures the number of participants who did not have another surgery for treatment of lumbar spinal stenosis at the same spinal level that was originally treated. Data, including adverse events, were monitored, evaluated and assessed for evidence of additional surgical treatment at the spinal level that was originally treated.|24 months|"The Overall Number of Participants Analyzed in the FLEXUS arm and X-STOP arm is the number of subjects who started the Study in the respective arm. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
1412940|NCT01156675|Primary|Number of Participants With a Successful Neurologic Status|"Neurological status is based on four types of measurement parameters: motor, sensory, reflexes, and special assessments. Each parameter will be coded as follows:~Motor 0 Total Paralysis~Palpable or Visible Contraction~Active Movement, Gravity Eliminated~Active Movement, Against Gravity~Active Movement, Against Some Resistance~Active Movement, Against Full Resistance~Sensory 0 Absent~Impaired~Normal~Reflexes 0 Absent or Trace~Hyper-reflexic~Normal or hypo-reflexic~Straight Leg Raise 0 0°-70° (abnormal)~1 >70°-90° (normal)~If all evaluations for the parameter are determined to be normal, then the parameter is given a normal status. If any evaluations for the parameter are abnormal, then the parameter is given an abnormal status. The overall neurological status will be considered a success if and only if all the four parameters are stable or improved."|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers in the Participant Flow module. The discrepancy is due to two less subjects having neurologic status data at 24 months in the FLEXUS arm and one less subject with neurologic status data at 24 months in the X-STOP arm. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
1412941|NCT01156675|Primary|Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score|"Change in the Zurich Claudication Questionnaire (ZCQ) score at 24 months compared with the score at baseline as follows:~Change of >0.5 points in Physical Function on a scale of 1-4 points (lower values are considered a better outcome)~Change of >0.5 points in Symptom Severity on a scale of 1-5 points (lower values are considered a better outcome)~Satisfaction of <2.5 points on a scale of 1-4 points (lower values are considered a better outcome) The Zurich Claudication Questionnaire is a three part form that quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment."|24 months|"The Overall Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow module. The discrepancy in the numbers is due to an additional subject having ZCQ data at 24 months in the FLEXUS arm and one less subject with ZCQ data at 24 months in the X-STOP group. No data was collected for the No Treatment arm."|||Participants|||Count of Participants
1412942|NCT01156597|Secondary|Cholesterol Efflux Capacity of HDL|The ability of serum HDL to remove cholesterol from cultured cells will be assessed as an in vitro method to evaluate a functional changes in HDL mediated by changes due to pioglitazone treatment. Cells were incubated with 2% serum from each study subject diluted in culture medium and incubations were performed for a total of 4 hours. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool as described in detail by de la Llera-Moya et al (de la Llera-Moya M, Drazul-Schrader D, Asztalos BF, Cuchel M, Rader DJ, Rothblat GH. The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages. Arterioscler Thromb Vasc Biol. 2010 Apr;30(4):796-801. doi: 10.1161/ATVBAHA.109.199158. PMID: 20075420).|24 weeks||||Ratio||Standard Deviation|Mean
1412943|NCT01156597|Secondary|HDL Apolipoprotein Levels at Study End-point|Lipoproteins will be isolated and analyzed using the gradient ultracentrifugation-high pressure liquid chromatography technique to isolate very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL, and high density lipoprotein (HDL) subfractions. Protein and lipid compositions of HDL is determined|24 weeks||||mg/dL||Standard Deviation|Mean
1412944|NCT01156597|Primary|Increased HDL-Cholesterol and Decreased Triglycerides|"The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation:~Change=[100%*(Endpoint value – Baseline Value)/Baseline Value]"|24 weeks|All subjects that completed the study were used for the final analysis|||% Change||Standard Deviation|Mean
1412945|NCT01156571|Secondary|Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild|GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial|48 hours after randomization||||participants|||Number
1412948|NCT01156532|Secondary|Mean Dermatology Life Quality Index (DLQI) Score Over Time|DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.|||units on a scale||Standard Deviation|Mean
1412949|NCT01156532|Secondary|Mean Psoriasis Area and Severity Index (PASI) Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model.|Baseline, Week 4, Week 8, Week 16|Participants with available data.|||units on a scale||Standard Deviation|Mean
1412950|NCT01156532|Secondary|Adherence to Adalimumab Treatment|Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.|up to 16 weeks|Participants who received at least one dose of study treatment.|||participants|||Number
1412951|NCT01156532|Secondary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.|From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).|Participants who received at least one dose of study treatment.|||participants|||Number
1412952|NCT01156532|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16|EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.|Baseline, Week 16|Participants with available data.|||units on a scale||Standard Deviation|Mean
1412953|NCT01156532|Primary|Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data.|||percentage of participants||95% Confidence Interval|Number
1412954|NCT01156532|Primary|Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.|Baseline to Week 16|Participants with available data. One participant was excluded from the analysis because only baseline and not follow-up information was available. Furthermore, 3 participants did not have their PASI measurement available either at baseline or at their last follow-up visit.|||percentage of participants||95% Confidence Interval|Number
1412955|NCT01156480|Secondary|Mortality||at 40 weeks corrected gestational age|||||||
1412956|NCT01156480|Secondary|Growth Velocity||at 40 weeks CGA|||||||
1412957|NCT01156480|Secondary|Length of Stay|this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA.|at 40 weeks corrected gestational age|||||||
1412958|NCT01156480|Secondary|Time to Full Enteral Feeds|this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA|at 40 weeks corrected gestational age|||||||
1412959|NCT01156480|Secondary|Time on Parenteral Nutrition||at 40 weeks corrected gestational age|||||||
1412960|NCT01156480|Secondary|Incidence of Sepsis||at 40 weeks corrected gestational age|||||||
1412961|NCT01156480|Secondary|Need for Gastrointestinal Surgery||at 36 weeks corrected gestational age|||||||
1412962|NCT01156480|Secondary|Spontaneous Intestinal Perforation||at 36 weeks corrected gestational age|||||||
1412963|NCT01156480|Secondary|Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)||36 weeks corrected gestational age|||||||
1412964|NCT01156480|Primary|CRP Level|C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC|7 days||||mg/L|||Number
1412965|NCT01156480|Primary|CRP Level|C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.|3 days||||mg/L|||Number
1412966|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412967|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412968|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412969|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412970|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412971|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412972|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412973|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 25|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 25|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412974|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412975|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412976|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412977|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1416380|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 24 Hours||Interval from study drug administration to vaginal delivery within 24 hours|Intention-to-Treat (ITT) Population|||percentage of participants||95% Confidence Interval|Number
1412978|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412979|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412980|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412981|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412982|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412983|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412984|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412985|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412986|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412987|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412988|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412989|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 24 - Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 24 - Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412990|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412991|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412992|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412993|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412994|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412995|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412996|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412997|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 5|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 5|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412998|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1412999|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413206|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|6 months|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
1413000|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413001|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413002|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413003|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413004|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413005|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 3|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 3|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413006|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413007|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413008|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413009|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413010|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1419033|NCT01107197|Primary|Rate of Healing|healing is defined as reduction in ulcer area (the percentage of change)|8 weeks of nutritional support (baseline and week 8)||||percent change||Standard Deviation|Mean
1413011|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413012|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413013|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 – Post-treatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Post-treatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413014|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413015|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413016|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413017|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413018|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413019|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413020|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413033|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 5|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 5|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1419034|NCT01107015|Primary|HBA1c at One Year||one year||||percentage of HbA1c||Standard Deviation|Mean
1413021|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Day 1 – Baseline/Pretreatment|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Day 1 – Baseline/Pretreatment|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413022|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Uvula/Oropharynx at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413023|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Hard/Soft Palate at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413024|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Tongue at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413025|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Gingiva at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413026|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Mucobuccal Fold at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413027|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Sublingual Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413028|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Labial Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413029|NCT01156376|Primary|Percentage of Subjects in Irritation Score Category for Buccal Mucosa at Screening|The dental examiner rated the irritation/inflammation on the soft tissues using a scale where 0=none (normal), 1=erythema plus slight edema (mild), 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate), 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).|Screening|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product. No imputations were made for missing data.|||Percentage of Participants|||Number
1413030|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 25|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 25|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1413031|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 – Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 – Post-treatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1413032|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 24 – Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 24 – Pretreatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1413034|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 3|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 3|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1413035|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 – Post-treatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 – Post-treatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1413036|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Day 1 – Baseline/Pretreatment|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Day 1 – Baseline/Pretreatment|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1413037|NCT01156376|Primary|Percentage of Participants With an Abnormal Condition by Anatomical Site at Screening|Buccal, labial and sublingual mucosae, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations were examined. The dental examiner evaluated any condition as either normal or abnormal.|Screening|Analysis was based on subjects with measurements for this variable.|||Percentage of Participants|||Number
1413038|NCT01156363|Secondary|Percentage of Participants Requiring Dose Adjustments|Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.|Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8|ITT population. Here, number of participants analyzed signifies participants who were evaluable for this outcome and n signifies participants who were evaluable for specified time-point.|||percentage of participants|||Number
1413039|NCT01156363|Secondary|Mean Time Participants Spent Having Hb Concentration Within Target Range|Target Hb concentration was between 10.0 and 12.0 g/dL.|Weeks 1 to 32|ITT Population.|||days||Standard Deviation|Mean
1413040|NCT01156363|Secondary|Change in Hb Concentration Between Reference and Treatment Period|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.|||g/dL||Standard Deviation|Mean
1413041|NCT01156363|Secondary|Mean Monthly Hb Values|The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8|ITT Population. Here, n signifies participants evaluable at specified time-point for each arm, respectively.|||g/dL||Standard Deviation|Mean
1413042|NCT01156363|Primary|Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range|Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.|Weeks 1 to 32|ITT Population.|||percentage of participants|||Number
1413043|NCT01156311|Other Pre-specified|Number of New or Newly Enlarging T2 Lesions|The number of new T2 lesions divided by the number of months since the reference visit during the Monotherapy Period and the Add-On Therapy Period.|Week -8 to Week 24|Number of participants in the Gd cohort with analyzable data in both Monotherapy and Add-on Therapy Periods. Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.|||lesions per month||Standard Deviation|Mean
1413044|NCT01156311|Other Pre-specified|Average Number of New Gd-Enhancing Lesions: Weeks -4, 0 Average Versus Weeks 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing MRI scans).|Week -4 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.|||lesions||Standard Deviation|Mean
1413045|NCT01156311|Other Pre-specified|Average Number of Gadolinium (Gd)-Enhancing Lesions: Week -8, -4, 0 Average Versus Week 16, 20, 24 Average|The average is calculated as (total number of lesions in non-missing scans / number of non-missing magnetic resonance imaging [MRI] scans).|Week -8 through Week 24|Gd cohort: BG00012-dosed participants with at least 1 Gd-enhancing lesion in any 1 of the 3 scans (Weeks -8, -4, or 0) during the Monotherapy Period.|||lesions||Standard Deviation|Mean
1413046|NCT01156311|Primary|Worst Post-Baseline Values for Selected Urinalysis Parameters That Require Further Evaluation for Combination Therapy|Percentage of participants with post-baseline values for selected urinalysis parameters requiring further evaluation. For urine microscopy, results were categorized for male and female participants. For males, normal/negative was considered 0 to 3 red blood cells/high-power field (rbc/hpf), and positive was categorized in the following stages: 4 to 10, 11 to 20, 21 to 149, and ≥ 150 rbc/hpf. For females, normal/negative was considered 0 to 8 rbc/hpf, and positive was categorized in the following stages: 9 to 20, 21 to 30, 31 to 149, and ≥ 150 rbc/hpf.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy; n=participants in the safety population with at least 1 post-baseline value.|||percentage of participants|||Number
1413047|NCT01156311|Primary|Maximum Post-Baseline Values: Liver Enzymes for Combination Therapy|Percentage of participants with post-baseline liver enzyme values above the upper limit of normal (ULN). Liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), and bilirubin. Elevated ALT/AST (ALT/AST ≥ 3*ULN) concurrent with elevated total bilirubin was also evaluated.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.|||percentage of participants|||Number
1423340|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Creatinine|Change from baseline|Baseline and 52 week after||||mg/dL||Standard Deviation|Mean
1413048|NCT01156311|Primary|Potentially Clinically Significant Hematology Laboratory Abnormalities for Combination Therapy|Percentage of participants with potentially clinically significant hematology laboratory abnormalities.|collected from the start of BG00012 administration through to Week 26 +/- 5 days|Participants in the safety population with at least one post-baseline value. Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.|||percentage of participants|||Number
1413049|NCT01156311|Primary|Summary of Treatment-emergent Adverse Events (TEAEs) Occurring Post-BG00012 Dosing (Add-on Therapy Period)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. TEAE was defined as having an onset date that was on or after the start of study treatment (BG00012), or that worsened after the start of study treatment.|AEs were collected from enrollment until the final study visit (Week 26 +/-5 days).|The Safety Population for the Combination Therapy Period was defined as any participant who took at least 1 capsule of BG00012 concurrently with the background therapy.|||percentage of participants|||Number
1413050|NCT01156311|Other Pre-specified|Summary of Adverse Events (AEs) Occurring Before BG00012 Dosing (Monotherapy Period)|Percentage of participants with AEs, serious AEs (SAEs), and discontinuations due to AEs. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; was any other medically important event that, in the opinion of the Investigator, jeopardized the participant or required intervention to prevent one of the other outcomes above. AEs were categorized as mild, moderate, or severe. All AEs occurring from enrollment to the day before BG00012 dosing are included.|from time of enrollment until day before first administration of BG00012 (Week -8 to Week 0)|The Safety Population for the Monotherapy Period was defined as any participant who took at least 1 dose of background therapy.|||percentage of participants|||Number
1413051|NCT01156142|Secondary|Patient Preference for Continuing Therapy With Oral Doxepin Hydrochloride|After each dose was administered, patients were asked if they would like to continue rinses with that particular agent. The percentage of patients who expressed an interest in continuing therapy are reported below.|Up to 9 days||||percentage of patients|||Number
1413052|NCT01156142|Secondary|Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash|The incidence of utilizing additional analgesics between 2 and 4 hours after the initial mouthwash will be compared between the arms by the Chi-square test .|Up to 9 days||||percentage of patients|||Number
1413053|NCT01156142|Secondary|Total Drowsiness Increase|The total drowsiness increase will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your DROWSINESS now?') used 11-point numerical analog scales (0 (no drowsiness) to 10 (extreme drowsiness, leading to sleep) scores) to measure total drowsiness increase. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. The statistical analysis will be the same as the primary analysis.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.|||units on a scale||Standard Deviation|Mean
1413054|NCT01156142|Secondary|Total Stinging or Burning From the Oral Rinse|The total stinging or burning from the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes any STINGING OR BURNING FROM THE ORAL RINSE now?') used 11-point numerical analog scales (0 (no stinging or burning) to 10 (worst stinging or burning possible) scores) to total stinging or burning from the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.The statistical analysis will be the same as the primary analysis.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.|||units on a scale||Standard Deviation|Mean
1413055|NCT01156142|Secondary|Total Taste of the Oral Rinse|The total taste of the oral rinse will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6 , and analyzed in the same way as the primary endpoint. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes the TASTE OF THE ORAL RINSE now?') used 11-point numerical analog scales (0 (acceptable taste) to 10(terrible taste), with higher values representing worse outcome) to evaluate the total taste of the oral rinse. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.|Up to 9 days|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.|||units on a scale||Standard Deviation|Mean
1448797|NCT00859469|Primary|Best Response|Radiologic response by RECIST criteria|Two months|intention to treat principle|||participants|||Number
1413056|NCT01156142|Primary|Total Pain Reduction (Mouth and Throat)|The total pain reduction will be calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your MOUTH PAIN due to your radiation treatment now?') used 11-point numerical analog scales (0 (no pain) to 10 (worst pain imaginable or possible) scores) to measure pain. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs.|Baseline and Day 1|If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis. The primary analysis of the total pain reduction will only use primary data from the first phase.|||units on a scale||Standard Deviation|Mean
1413057|NCT01156116|Secondary|Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2|"The average diastolic blood pressure over a 24-hr period was calculated for each patient.~Change = Week 2 - Baseline"|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.|||mmHg||95% Confidence Interval|Mean
1413058|NCT01156116|Secondary|Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2|"The average systolic blood pressure measured over a 24-hr period was calculated for each patient.~Change = Week 2 - Baseline."|Baseline and Week 2|Patients were excluded from the analysis if they were missing blood pressure data at both Baseline and Week 2.|||mmHg||95% Confidence Interval|Mean
1413059|NCT01156116|Secondary|Change From Baseline in Insulin Sensitivity (SI) at Week 2|"SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).~Change = Week 2 - Baseline."|Baseline and Week 2|One patient from each group was excluded from the analysis since they were missing SI data at both Baseline and Week 2.|||[mU/L]^-1·[min]^-1||95% Confidence Interval|Mean
1413060|NCT01156116|Primary|Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2|"The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule .~Change = Week 2 - Baseline."|Baseline and Week 2|One patient in the Placebo group who withdrew prior to any testing was excluded from the analysis.|||(mg/dL)*min||95% Confidence Interval|Mean
1413061|NCT01156051|Secondary|Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)|Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.|||minutes||Standard Deviation|Mean
1413062|NCT01156051|Secondary|Change in Baseline to Treatment Latency to Persistent Sleep (LPS)|Change in an objective measure of sleep onset, using polysomnography.|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled; two were disqualified: one (treatment) was lost to follow-up,and one (placebo) was noncompliant with the protocol.|||minutes||Standard Deviation|Mean
1413063|NCT01156051|Secondary|Change in Baseline to Treatment ADHD-Rating Scale IV Total Score|Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).|Baseline to last observation carried forward (after at least one week of dose stability)|29 children enrolled, but two were discontinued before termination data was available: one (treatment) was lost to follow up and one (placebo) was noncompliant with the protocol.|||units on a scale||Standard Deviation|Mean
1413064|NCT01156051|Primary|Change in Polysomnographic Total Sleep Time (TST)|Change in objective measures of sleep, using polysomnography|Baseline to last observation carried forward (after at least one week of dose stability)|29 children were enrolled, one (treatment) was lost to follow up an one (placebo) was discontinued due to noncompliance with protocol.|||minutes||Standard Deviation|Mean
1413065|NCT01156012|Primary|Change From Baseline in Intraocular Pressure (IOP)|"The worse eye is defined as:~If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye.~If only one eye is eligible this eye is the worse eye.~If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0.~If both eyes have the same IOP at D0 the worse eye is the right eye."|Day 0 and Day 84|mITT set : All randomised patients, with at least one eligible eye, having received at least one dose of the Investigational Medicinal Product, and for whom any follow-up IOP recording was available for the worse eye.|||mmHg||Standard Deviation|Mean
1413066|NCT01155999|Primary|The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3|Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale).|Day 3|The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye.|||participants|||Number
1413067|NCT01155869|Secondary|Treatment Participation|Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation|16 weeks||||percentage of visits|Participants||Number
1413068|NCT01155869|Primary|Mean Weekly Self-reported Alcohol Consumption|Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.|24 weeks||||standard drink||Standard Deviation|Mean
1413069|NCT01155830|Secondary|TNF-alpha, Maximum|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|up to 2 weeks||||pg/mL||Standard Error|Mean
1423341|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and 52 week after||||U/L||Standard Deviation|Mean
1413070|NCT01155830|Primary|TNF-alpha, Baseline|This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).|Baseline||||pg/mL||Standard Error|Mean
1413071|NCT01155726|Primary|Average Subjective Comfort|"Participants were asked, How would you rate your comfort with your study lenses? and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together."|Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3|Per protocol|||Units on a scale||Standard Deviation|Mean
1413072|NCT01155661|Secondary|Change From Baseline to Week 54 Endpoint in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline pulse rate value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1413073|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Blood Pressure|Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline value, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline blood pressure value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
1413074|NCT01155661|Secondary|The Number of Participants Experiencing Clinically Significant Effects as a Function of CYP2D6 Predicted Phenotype at Week 54 Endpoint|A clinically significant effect was defined as a treatment-emergent adverse event; a reported adverse event that first occurred or worsened during the treatment phase. CYP2D6 predicted phenotype was classified as poor metabolizer (PM) or non-poor metabolizer (non-PM). The number of participants who reported at least one treatment-emergent adverse event is presented for each phenotype classification.|Baseline, Week 54|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||participants|||Number
1413075|NCT01155661|Secondary|Plasma Concentration of LY2216684||Weeks 2, 6, and 8|All enrolled participants with at least one plasma sample.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1413076|NCT01155661|Secondary|Percentage of Participants Who Meet Remission Criteria of Depressive Symptoms by Week 8|Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of <= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first remission was calculated. In the calculation, participants who did not meet remission criteria were considered as right-censored observations. The estimated percentage of participants who meet remission criteria by Week 8 from the Kaplan-Meier method is presented.|Baseline, Week 8|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||percentage of participants|||Number
1413077|NCT01155661|Secondary|Percentage of Participants With Discontinuation-Emergent Adverse Events (DEAEs)|Discontinuation-emergent adverse events (DEAEs) were events that first occurred or worsened within 1-week after abrupt discontinuation of LY2216684 (edivoxetine) treatment.|Up to1 week after discontinuation of treatment|All enrolled participants who abruptly discontinued LY2216684 (edivoxetine) treatment either at the end of the study or after early withdrawal from the study and who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||percentage of participants|||Number
1413078|NCT01155661|Secondary|Percentage of Participants Who Reported Resource Utilization (RU) at Baseline and at the Week 54 Endpoint|The Resource Utilization (RU) form assesses the frequency and type of medical services (a primary care visit and/or a psychiatrist visit) that participants used within the previous year (for the baseline visit) or within approximately the previous 3 months (for post-baseline visits or the Week 54 endpoint). The percentage of participants who reported greater than zero number of primary care doctor visits and greater than zero number of psychiatrist visits is presented.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Resource Utilization value.|||percentage of participants|||Number
1413079|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) is a self-administered 16 item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total raw score is the sum of Items 1 to 14 and ranges from 14 to 70. The raw scores are converted to and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) percent of maximum possible score value.|||units on a scale||Standard Error|Least Squares Mean
1413080|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)|The EQ-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline EuroQol Questionnaire - 5 Dimension (EQ-5D) visual analog scale value.|||units on a scale||Standard Error|Least Squares Mean
1414048|NCT01148836|Primary|Right Ventricle Myocardial Performance|Tei Index=(IRT+ICT)/ET, where IRT is isovolumic|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||ratio||Standard Deviation|Mean
1413081|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores|The Sheehan Disability Scale (SDS) Global Functional Impairment Score (total score) and Subscores were completed by the participant and were used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work life (work/school impairment [imp] score), social life (social life/leisure activities impairment [imp] score), and family life (family life/home responsibilities impairment [imp] score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Sheehan Disability Scale (SDS) subscale score.|||units on a scale||Standard Error|Least Squares Mean
1413082|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscale. Scores of 11 or more on either subscale were considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Hospital Anxiety and Depression Scale (HADS) anxiety subscale value.|||units on a scale||Standard Error|Least Squares Mean
1413083|NCT01155661|Secondary|Percentage of Participants Who Meet Response Criteria of Depressive Symptoms by Week 8|Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Kaplan-Meier product limit method of time to first response was calculated. In the calculation, participants who did not meet response criteria were considered as right-censored observations. The estimated percentage of participants who met response criteria by Week 8 from the Kaplan-Meier method is presented.|Baseline, Week 8|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||percentage of participants|||Number
1413084|NCT01155661|Secondary|Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint|Remission criteria was defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of <= 10. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of remission at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||Probability of remission|||Number
1413085|NCT01155661|Secondary|Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint|Response criteria was defined as at least a 50% decrease from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). This analysis models the probability of response at each visit, and the estimated probabilities were adjusted for visit and the baseline MADRS total score.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Montgomery-Asberg Depression Rating Scale (MADRS) total score value.|||Probability of response|||Number
1413086|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores|The Fatigue Associated with Depression (FAsD) is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant’s lives with responses from 1 (not at all) to 5 (very much). The “Experience Score” was derived by taking the mean of Items 1 through 6, the “Impact Score” was derived by taking the mean of Items 7 through 13 (applicable items only), and the “Average Score” was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Fatigue Associated with Depression (FAsD) average score and subscale score.|||units on a scale||Standard Error|Least Squares Mean
1413087|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S)|Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Clinical Global Impression - Severity (CGI-S) value.|||units on a scale||Standard Error|Least Squares Mean
1413098|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413088|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and depression subscales. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline Hospital Anxiety and Depression Scale (HADS) depression subscale value.|||units on a scale||Standard Error|Least Squares Mean
1413089|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS had a 10-item checklist. Items were rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline MADRS individual item and total score value.|||units on a scale||Standard Error|Least Squares Mean
1413090|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline CPFQ total score value.|||units on a scale||Standard Error|Least Squares Mean
1413091|NCT01155661|Secondary|Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale|The ASEX scale was used to assess sexual functioning in both males and females. The ASEX total score for the male and female version was calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for investigator, visit, baseline score, and baseline-by-visit.|Baseline, Week 54|All enrolled participants with a baseline and at least one post-baseline ASEX total score value.|||units on a scale||Standard Error|Least Squares Mean
1413092|NCT01155661|Secondary|Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Baseline through Week 54|All enrolled participants with a baseline and at least one post-baseline C-SSRS value.|||percentage of participants|||Number
1413093|NCT01155661|Primary|The Number of Participants Experiencing Clinically Significant Effects|"A clinically significant effect was defined as a serious adverse event, regardless of causality.~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Baseline through 54 weeks|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||participants|||Number
1413094|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413095|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413096|NCT01155570|Primary|Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4|DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413097|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413099|NCT01155570|Primary|Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4|DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413100|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 24|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 24|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413101|NCT01155570|Secondary|Physician’s Overall Response Rating At Week 24|"Overall response rating, according to investigator’s subjective clinical opinion. The level of overall improvement rating was categorized as “markedly improved,” “improved,” “not changed,” or not assessable, comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions."|Baseline and Week 24|Participants in the Efficacy Analysis Population with assessment at Week 24.|||participants|||Number
1413102|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 16|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 16|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413103|NCT01155570|Primary|Pain Visual Analog Scale (VAS) at Week 4|Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).|Week 4|Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413104|NCT01155570|Primary|Dermatology Life Quality Index at Week 24|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413105|NCT01155570|Primary|Dermatology Life Quality Index at Week 16|Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413106|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
1413107|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16|PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
1413108|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.|Baseline and Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
1413109|NCT01155570|Primary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.|Baseline and Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||percentage of participants|||Number
1413110|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413151|NCT01155180|Primary|Percent Change From Baseline in Body Weight at 6 Months|Body weight was recorded to the nearest 0.1 kg at baseline and at 6 months after randomization. Then the percentage change was calculated.|baseline and 6 months after randomization||||percentage change||Standard Error|Mean
1413111|NCT01155570|Primary|Psoriasis Area and Severity Index (PASI) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413112|NCT01155570|Primary|Physician's Global Assessment at Week 24|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 24|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413113|NCT01155570|Primary|Physician's Global Assessment at Week 16|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 16|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413114|NCT01155570|Primary|Physician's Global Assessment At Week 8|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 8|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413115|NCT01155570|Primary|Physician's Global Assessment at Week 4|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);~1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);~2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);~3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);~4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);~5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe)."|Week 4|Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.|||units on a scale||Standard Deviation|Mean
1413116|NCT01155570|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs|This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than “not related” (ie, “probable,” “possible,” or “unclear”). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.|From study registration through Week 24|Safety Analysis Population|||participants|||Number
1413117|NCT01155531|Primary|Safety of Sertraline and Telenzepine Combination|safety of the drug combination was measured in terms of number of adverse events during the study period.|7 days||||number of adverse events|||Number
1413118|NCT01155531|Primary|Changes in the Meal Calories Consumed|The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.|The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.||||calorie||Standard Deviation|Mean
1413152|NCT01155167|Secondary|Radial Artery Patency|Prior to discharge, color doppler ultrasound was used at the site where the sheath had been inserted to determine whether the radial artery was patent (open, unobstructed).|24 hours|per protocol|||participants|||Number
1413153|NCT01155167|Secondary|Radial Artery Spasm During Catheterization|The blinded clinical operator recorded whether radial artery spasm occurred, as detected by resistance to advancing the catheter through the radial artery, by difficulty in torquing the catheter, or by difficulty in removing the catheter.|2 hours|All participants except 3 participants in the Topical Dilator arm for whom RAS data were not recorded|||participants|||Number
1413119|NCT01155531|Primary|Changes in the VAS Score From Baseline.|The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject’s room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: “How hungry are you now?” The anchor points of the 100mm scale were “I am not hungry at all” and “Never more hungry” corresponding to 0 mm and 100 mm respectively. The subjects’ VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group.|The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal||||mm||Standard Deviation|Mean
1413120|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 2|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated (APaT): All participants who received at least one dose of study treatment.|||Participants|||Number
1413121|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Week 27 to Week 52|All Participants as Treated: All participants who received at least one dose of study treatment.|||Participants|||Number
1413122|NCT01155479|Primary|Number of Participants Who Discontinued Study Due to an AE in Part 1|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.|||Participants|||Number
1413123|NCT01155479|Primary|Number of Participants With Adverse Events (AEs) in Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Day 1 to Week 26|All Participants as Treated: All participants who received at least one dose of study treatment.|||Participants|||Number
1413124|NCT01155479|Secondary|Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.|||Score on a Scale||Standard Error|Mean
1413125|NCT01155479|Secondary|Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)|UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.|||Percentage of Responders||95% Confidence Interval|Number
1413126|NCT01155479|Primary|Change From Baseline in the Sum of Unified Parkinson’s Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.|Baseline and Week 26|Full Analysis Set (FAS): All randomized and treated participants with at least one post-baseline value.|||Score on a Scale||Standard Error|Mean
1413154|NCT01155167|Primary|Change in Radial Artery Diameter|The cross-sectional radial artery area was measured using a high frequency linear array transducer. All ultrasound measurements were made 2 cm proximal to the radial styloid process. Each measurement was performed 3 times and averaged. At least 30 minutes after the application of topical creams, the radial artery diameter was again measured in the same fashion.|Baseline and after 30 minutes of drug application||||Percent change||Standard Deviation|Mean
1413155|NCT01155154|Primary|Number of Participants With Presence of Wound Infection|Hand lacerations will be examined 10-14 days after initial wound closure and will be assessed for presence of infection.|2 weeks||||participants|||Number
1413127|NCT01155466|Secondary|"Change From Baseline at Week 12 in Mean On Time Without Troublesome Dyskinesia"|"When a participant is on without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as off, on without dyskinesia, on with non-troublesome dyskinesia, on with troublesome dyskinesia, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in on without troublesome dyskinesia time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.|||Hours/day||Standard Error|Mean
1413128|NCT01155466|Secondary|"Percentage of Participants With >30% Change (Reduction) From Baseline at Week 12 in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit."|Baseline and Week 12|The number of randomized and treated participants with a Week 12 value.|||Percentage of participants|||Number
1413129|NCT01155466|Primary|Change From Baseline at Week 12 in Epworth Sleepiness Scale (ESS)|The ESS is a self-administered questionnaire providing a measure of a person’s general level of daytime sleepiness, or their average sleep propensity in daily life. The scale consists of 8 situations in which the participant rates their tendency to become sleepy on a scale of 0=no chance of dozing to 3=high chance of dozing. The overall score is the sum of the scores for the 8 situations for a minimum of 0 and a maximum of 24.|Baseline and Week 12|The number of participants who received at least one dose of study drug and had baseline and Week 12 data|||Scores on a scale||Standard Deviation|Mean
1413130|NCT01155466|Primary|Percentage of Participants With Suicidality|The percentage of participants with suicidality using the Columbia - Suicide Severity Rating Scale (C-SSRS) was reported. The C-SSR was used in this study only for the purpose of safety monitoring by measuring the incidence of different types of suicidality categories during treatment. The assessment was done by the nature of the responses, not by a numbered scale. Participants who reported at least one occurrence of suicidal behavior or suicidal ideation were counted as having experienced suicidality. Suicidal behavior included suicide attempt, aborted attempt, interrupted attempt, or preparatory behavior. Suicidal ideation included a wish to die or active suicidal thought with or without method, intent or plan.|Up to Week 12|The number of participants who received at least one dose of study drug|||Percentage of participants|||Number
1413131|NCT01155466|Primary|Number of Participants With Aspartate Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with aspartate aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
1413132|NCT01155466|Primary|Number of Participants With Alanine Aminotransferase >=3 Times the Upper Limit of Normal|The number of participants with alanine aminotransferase >=3 times the upper limit of normal and a >=10% increase was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
1413133|NCT01155466|Primary|Number of Participants With Diastolic Blood Pressure >=105 mm Hg|The number of participants with Diastolic Blood Pressure >=105 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
1413134|NCT01155466|Primary|Numberof Participants With Systolic Blood Pressure >=180 mm Hg|The number of participants with Systolic Blood Pressure >=180 mm Hg was reported.|Up to Week 14|The number of participants who received at least one dose of study drug|||Participants|||Number
1413135|NCT01155466|Primary|"Change From Baseline in Mean Off Time"|"The on state is defined as the period of time during which a patient's symptoms of PD improve or disappear following treatment with L-dopa or dopamine agonists. The off state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as off, on, or asleep on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in off time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects and subject as random effect."|Baseline and Week 12|The number of randomized and treated participants with at least one post baseline value.|||Hours/day||Standard Error|Mean
1413136|NCT01155388|Secondary|Pharmacokinetics: Area Under The Curve Of Ferumoxytol|Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose|The PK population included all randomized participants who received at least 1 dose of study drug and consented to PK sampling. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
1413156|NCT01155141|Secondary|Total Cholesterol||Baseline - Month 6||||mg/dL||Standard Deviation|Median
1413157|NCT01155141|Secondary|Glucose||Baseline - Month 6||||mg/dL||Standard Deviation|Median
1413158|NCT01155141|Secondary|Diastolic Blood Pressure||Baseline - Month 6||||mm Hg||Standard Deviation|Median
1413159|NCT01155141|Secondary|Systolic Blood Pressure||Baseline - Month 6||||mm Hg||Standard Deviation|Median
1413160|NCT01155141|Secondary|Weight||Baseline - Month 6||||kg||Standard Deviation|Median
1413161|NCT01155141|Primary|Protein/Creatinine Ratio||Baseline - Month 6||||unitless||Standard Deviation|Median
1413162|NCT01155141|Secondary|eGFR||Baseline - Month 6||||mL/min/1.73m^2||Standard Deviation|Median
1413137|NCT01155388|Primary|Mean Change In Hemoglobin From Baseline To Week 5|Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the sponsor to discontinue the combined AMAG FER-CKD-252 and AMAG FER-CKD-251 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5|Intent-to-Treat Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
1413138|NCT01155375|Secondary|Pharmacokinetics: Area Under The Curve Of Ferumoxytol|Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets.|Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose|The PK population included all randomized participants who received at least 1 dose of study drug and consented to PK sampling. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
1413139|NCT01155375|Primary|Mean Change In Hemoglobin From Baseline To Week 5|Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets.|Baseline, Week 5|Intent-to-Treat Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible.||||||
1413140|NCT01155336|Secondary|Cardiac Electrophysiology|A 20-minute supine 12-lead Holter ECG will allow the quantification of a series of standard ECG parameters as well as provide insight into frequency-domain HRV parameters, QRS duration and morphology, using signal-averaged ECG (SAECG), repolarization morphology, and variability utilizing specialized programs.|1 week|Data was not collected for this outcome measure.||||||
1413141|NCT01155336|Primary|Platelet Function|Platelet function will be measured with PFA-100 test which has been shown to correlate with an increased risk for cardiovascular events in several well conducted studies and in a meta-analysis. The PFA-100 measures the number of seconds required for a clot to form in whole blood which is passed through an aperture in a cartridge coated with epinephrine. It is meant to imitate clotting in human arteries.|12 hours|We did not complete the study and no subjects were randomized to corn oil|||seconds||Full Range|Mean
1413142|NCT01155323|Primary|Limbal Hyperemia|This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.|after 1 week of wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
1413143|NCT01155323|Primary|Subjective Rating of Quality Perceptions|This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
1413144|NCT01155323|Primary|Corneal Staining|Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
1413145|NCT01155323|Primary|Subjective Rating of Handling|This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
1413146|NCT01155323|Primary|Vision Quality|This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
1413147|NCT01155323|Primary|Subjective Rating of Comfort|This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.|after 1 week of lens wear|The analysis population represents subjects that completed the study per protocol.|||Units on a scale||Standard Error|Least Squares Mean
1413148|NCT01155284|Secondary|2 Hour C-peptide AUC in Response to MMTT|Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal.|Month 6|Of the 70 subjects randomized, 58 completed treatment and analysis.|||pmol/L||95% Confidence Interval|Median
1413149|NCT01155284|Primary|2 Hour C-peptide AUC in Response to MMTT|Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal.|Month 12|Of the 70 subjects randomized, 58 completed treatment and analysis.|||pmol/L||95% Confidence Interval|Median
1413150|NCT01155219|Primary|Ocular Tolerance|Response defined as a combination of satisfactory or acceptable effect on IOP and a reduction of at least 20% of the total tolerance score in the worse eye.|Day 84|Full Analysis Set|||participants|||Number
1413163|NCT01155141|Primary|Serum Creatinine||Baseline - Month 6||||mg/dL||Standard Deviation|Median
1413165|NCT01155063|Secondary|Percentage of Participants With Recurrent Disease|Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).|Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1413166|NCT01155063|Secondary|Time to Discontinuation of Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1413167|NCT01155063|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1413168|NCT01155063|Secondary|Percentage of Participants Who Discontinued the Study Medication||Month 0 up to Month 36 or early withdrawal|Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.||||||
1413169|NCT01155063|Secondary|Number of Participants With Concomitant Medications|Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||Participants|||Number
1413170|NCT01155063|Secondary|Number of Participants With Concomitant Morbidities|Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||Participants|||Number
1413171|NCT01155063|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.|Month 0 up to Month 36 or early withdrawal|Safety analysis set included participants who received at least one dose of the study medication during the observation period.|||Participants|||Number
1413172|NCT01155024|Secondary|Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket|Number of participants indicating socket preference after 3 months usage of the direct manufactured prosthetic socket. Comparisons made to their previous traditional definitive prosthetic socket|3 months|Total number of participants completing the period (3 months usage of direct manufactured socket) and participants classified as 'Withdrawal by participant'. Analysis does not include participants who prematurely withdrew for reasons unrelated to the direct manufactured socket intervention.|||participants|||Number
1413173|NCT01155024|Secondary|Participant Socket Preference After Initial Fitting|Number of participants indicating socket preference after initial fitting of both socket interventions|Within the first 4-6 hours|Total number of participants completing period for both study interventions.|||participants|||Number
1413174|NCT01155024|Primary|Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting|The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)|Within the first 4-6 hrs|Per protocol analysis including all consented participants|||score on scale||Standard Deviation|Mean
1413175|NCT01155011|Primary|Minutes of Light to Moderate Physical Activity|Measured by 7 day accelerometry in adults, ≥65, using a 760 CPM cutpoint.|12 months||||minutes||Standard Deviation|Mean
1413176|NCT01155011|Primary|Daily Minutes of Physical Activity|Measured by 7 day accelerometry in adults, ≥65, with a 760 CPM cutpoint.|6 months||||minutes||Standard Deviation|Mean
1413177|NCT01155011|Primary|Daily Minutes of Physical Activity|Measured by 7 day accelerometry with a 760 cpm cutpoint.|Baseline||||minutes||Standard Deviation|Mean
1413178|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups"|6 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment|||U/L||Standard Deviation|Mean
1413179|NCT01154985|Primary|Alanine Transaminase (ALT) Levels|"Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups"|3 month endpoint|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment|||U/L||Standard Error|Least Squares Mean
1413180|NCT01154985|Primary|Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies|"Patient is considered a responder if histological examination shows:~Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis~A priori threshold for statistical significance is p<0.05, 1-sided"|12 months|Efficacy Evaluable Analysis Set - All patients in Full Analysis Set who have valid 12-month histological data without major protocol violations, including withdrawn patients with valid 12.5 month histological data after more than 6 months treatment|||participants|||Number
1413181|NCT01154816|Secondary|Serum Concentration of Alisertib on the Seventh Day of Administration Prior to the Administration of the Day 7 Dose.|Serum concentration of alisertib on the seventh day of administration prior to the administration of the day 7 dose in nanograms/milliliter.|day 7 of protocol therapy|Of all eligible patients enrolled, 31 provided a seventh day of administration prior to the administration of the day 7 dose sample for analysis.|||ng/ml||Standard Deviation|Mean
1413182|NCT01154816|Secondary|Serum Concentration of Alisertib on the Fourth Day of Administration Prior to the Administration of the Day 4 Dose|Serum concentration of alisertib on the fourth day of administration prior to the administration of the day 4 dose in nanograms/milliliter.|day 4 of protocol therapy|Of all eligible patients enrolled, 30 provided a fourth day of administration prior to the administration of the day 4 dose sample for analysis.|||ng/ml||Standard Deviation|Mean
1413183|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration Six Hours After Administration|Serum concentration of alisertib on the first day of administration six hours after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration six hours after administration sample for analysis.|||ng/ml||Standard Deviation|Mean
1413184|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration Three Hours After Administration|Serum concentration of alisertib on the first day of administration three hours after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration three hours after administration sample for analysis.|||ng/ml||Standard Deviation|Mean
1413185|NCT01154816|Secondary|Serum Concentration of Alisertib on the First Day of Administration One Hour After Administration|Serum concentration of alisertib on the first day of administration one hour after administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 16 provided a first day of administration one hour after administration infusion sample for analysis.|||ng/ml||Standard Deviation|Mean
1413186|NCT01154816|Secondary|Serum Concentration of Alisertib Prior to the First Day of Administration|Serum concentration of alisertib prior to the first day of administration in nanograms/milliliter.|day 1 of protocol therapy|Of all eligible patients enrolled, 32 provided a prior to the first day of administration sample for analysis.|||ng/ml||Standard Deviation|Mean
1413187|NCT01154816|Secondary|Number of Patients Cycles With Grade 3 or Higher Adverse Event|The number of patient-cycles in which the adverse event considered grade 3 or higher AE according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 considered by the treating physician to be possibly, probably or definitely related to alisertib.|Up to 24 months|116 patients contributed 360 patient-cycles to the analysis.|||Patient-cycle|||Number
1413188|NCT01154816|Primary|Number of Participants With Overall Response|For patients with recurrent solid tumors a patient who experienced a complete or partial response according to RECIST version 1.1 criteria is considered a responder. For patients with recurrent acute lymphoblastic leukemia a patient who experiences a bone marrow evaluation with < 5% blast cells on morphological evaluation of bone marrow will be considered a responder. For patients with recurrent acute myelogenous leukemia a patient who experiences a complete remission or complete remission with partial recovery of platelet count according to the AML International Working Group Criteria will be considered a responder.|From first dose of alisertib through 6 cycles of protocol therapy or until removal from protocol therapy whichever occurred first.|Of the 118 enrolled patients, two were not evaluable for the primary outcome measure. Neither received protocol therapy. One was enrolled in arm 11, one was enrolled in Arm 1.|||Patients|||Number
1413189|NCT01154751|Secondary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|2 Years|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
1413190|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|2 Years|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
1413191|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|1 Year|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
1413192|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|6 months|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
1413207|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|30 days|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
1413208|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|At baseline|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
1414049|NCT01148836|Primary|Right Ventricular Outflow|Velocity time interval|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||cm||Standard Deviation|Mean
1413193|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|30 days|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
1413194|NCT01154751|Secondary|Target Limb Ankle Brachial Index (at Rest)|"Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure~The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease."|At baseline|The number of patients analyzed is based on the data available.|||Ratio||Standard Deviation|Mean
1413195|NCT01154751|Secondary|Stent Fracture|"Stent fracture and Involuntary stent migration are types of device System Failure.~Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct."|1 to 3 Years|The number of patients analyzed is based on the data available.|||participants|||Number
1413196|NCT01154751|Secondary|Stent Fracture|"Stent fracture and Involuntary stent migration are types of device System Failure.~Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct."|1 to 2 years|The number of patients analyzed is based on the data available.|||participants|||Number
1413197|NCT01154751|Secondary|Stent Fracture|Stent fractures determined by fluoroscopy .|1 Year|The number of patients analyzed is based on the data available.|||participants|||Number
1413198|NCT01154751|Secondary|Target Lesion Revascularization|"Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.~Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)"|1 Year|The number of patients analyzed is based on the data available.|||percentage of participants|||Number
1413199|NCT01154751|Secondary|Target Lesion Revascularization|Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|6 months|The number of patients analyzed is based on the data available.|||percentage of participants|||Number
1413200|NCT01154751|Secondary|Restenosis by Duplex Ultrasound|In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.|1 Year|"If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.~The number of patients analyzed is based on the data available."|||percentage of participants|||Number
1413201|NCT01154751|Secondary|Restenosis by Duplex Ultrasound|In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.|6 months|"If no PSVR measurement was available, patient was excluded from restenosis analysis. If patient had TLR prior to duplex ultrasound, PSVR was excluded from restenosis analysis.~The number of patients analyzed is based on the data available."|||percentage of participants|||Number
1413202|NCT01154751|Secondary|Rutherford-Becker Clinical Category|"Rutherford/Becker Categories:~0 - Asymptomatic, no hemodynamically significant occlusive disease.~- Mild claudication.~- Moderate claudication.~- Severe claudication.~- Ischemic rest pain.~- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.~- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|30 days|The number of patients analyzed is based on the data available.|||percentage of participants|||Number
1413203|NCT01154751|Secondary|Number of Peri-procedural and Post-procedural Complications|Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.|30 days||||Number of compilcations|||Number
1413204|NCT01154751|Secondary|Number of Participants Experiencing Peri-procedural and Post-procedural Complications|Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.|30 days||||Participants|||Count of Participants
1413205|NCT01154751|Primary|Six-minute Walking Distance|The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.|1 Year|The number of patients analyzed is based on the data available.|||Meters||Standard Deviation|Mean
1413209|NCT01154699|Secondary|FEV1 %Predicted|Performed as part of spirometry|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.|||percentage of predicted FEV1||Standard Deviation|Mean
1413210|NCT01154699|Secondary|Short Form (SF-36) Health Survey|Well validated quality of life questionnaire that measures eight sub-sections, which are summed to yield a score from 0 (maximal disability) to 100 (no disability). The eight subsections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of the study|||units on a scale||Standard Deviation|Mean
1413211|NCT01154699|Secondary|Pittsburgh Sleep Quality Index (PSQI)|Well validated questionnaire used frequently to measure sleep quality over the prior 1 month. It consists of 19 individual items that combine to form 7 components summed to create one global score. The overall score is between 0 (better sleep) and 21 (worse sleep).|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.|||units on a scale||Standard Deviation|Mean
1413212|NCT01154699|Secondary|Epworth Sleepiness Scale (ESS)|8 item questionnaire to measure daytime sleepiness, with total score reported 0 (less sleepy) to 24 (most sleepy). Scores greater than or equal to 10 are considered excessive daytime sleepiness.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed both arms of this crossover study.|||units on a scale||Standard Deviation|Mean
1413213|NCT01154699|Primary|Airway Reactivity as Measured by Methacholine Challenge (PC20)|This is a physiological measurement derived from repeated breathing maneuvers which measures airway reactivity. Subjects are exposed to higher and higher concentrations of an airway irritant (in this case methacholine), and between each dose perform spirometry. The test is stopped after the forced expiratory volume in 1 second (FEV1) falls 20% below the baseline. The concentration of methacholine at which this occurs is called the PC20. Methacholine challenges are routinely used in the diagnosis of asthma, and in many asthma research studies to measure changes in airway reactivity.|Every 4 weeks during the 12 week study (at the start and end of the usual care period, and at the start and end of the Bilevel PAP intervention period)|All subjects completed the crossover study design|||mg/mL||Standard Error|Geometric Mean
1413214|NCT01154699|Primary|Asthma Control Test|Well validated questionnaire of asthma symptoms which includes 5 written questions. Each question is answered on a scale of 1-5, which are summed to report a range of asthma control from 5 to 25 (higher score indicates better asthma control).|Every 4 weeks during the 12 week study (at the start and end of the Usual Care period, and at the start and end of the Bilevel PAP intervention period)|All 21 patients went through usual care and bilevel PAP therapy|||units on a scale||Standard Deviation|Mean
1413215|NCT01154673|Primary|Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.|The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen.|Baseline to Week 48||||HIV DNA copies/ million CD4 cells||Full Range|Median
1413216|NCT01154634|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.|Pre-entry to follow-up||||Participants|||Number
1413217|NCT01154634|Secondary|Terminal Half-life (T Half)|Terminal half-life (T half)|0 to 12 hours post dose|"Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.~Two samples were not analyzed for T half due to technical reasons."|||hours||95% Confidence Interval|Geometric Mean
1413218|NCT01154634|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to maximum plasma concentration (Tmax)|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||hours||Full Range|Median
1413219|NCT01154634|Secondary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||nmol/L||95% Confidence Interval|Geometric Mean
1413220|NCT01154634|Secondary|Average Plasma Concentration (C Average)|Average plasma concentration|1 to 4 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||nmol/L||95% Confidence Interval|Geometric Mean
1413221|NCT01154634|Secondary|Area Under the Plasma Concentration Curve(AUC)|Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method|0 to 12 hours post dose|Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received.|||nmol*h/L||95% Confidence Interval|Geometric Mean
1413222|NCT01154634|Secondary|Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal|Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.|0 to 3 hours post meal|Data from two subjects were excluded from efficacy analysis due to incorrect medication received Data from five visits from two subject were excluded form analysis due to deviations caused by technical problems.|||relaxations||Full Range|Geometric Mean
1413223|NCT01154634|Primary|Reflux Episodes 0 to 3 Hours Post Meal|Total number of reflux episodes 0 to 3 hours post meal|0 to 3 hours post meal|Data from two subjects (one in arm AZD2516 5 mg, and one in arm Placebo) were excluded from efficacy analysis due to incorrect medication received.|||Episodes||Full Range|Geometric Mean
1413224|NCT01154452|Secondary|Response Rate (CR + PR) as Assessed by RECIST 1.1 (Phase Ib and II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|Up to 4 months||||participants|||Number
1413225|NCT01154452|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) of the combination of RO4929097 with and without GDC-0449 in patients with advanced sarcoma. (Phase II)|6 weeks||||percentage of participants|||Number
1413227|NCT01154335|Secondary|Response Rate|Response rate (RR) will be estimated as the proportion of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|18 months|Only patients who received at least 8 weeks of treatment were considered evaluable for response and were included in the response rate analysis|||participants|||Number
1413228|NCT01154335|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time between Day 1 Cycle 1 to the date of death from any cause. Those remaining alive will be censored at their last known assessment or follow-up.|18 months||||weeks||95% Confidence Interval|Median
1413229|NCT01154335|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time between Day 1 Cycle 1 and date of first documented recurrence or death. Patients who do not exhibit progression while on trial will be censored at their last known assessment. Progression is defined per RECIST criteria as either 1) at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum. OR 2) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|18 Months||||weeks||95% Confidence Interval|Median
1413230|NCT01154335|Primary|To Determine the Maximum Tolerated Dose (MTD) of the Combination of OSI-906 and Everolimus for the Treatment of Patients With Refractory Metastatic Colorectal Cancer.||18 Months||||milligrams|||Number
1413231|NCT01154322|Primary|Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|AHI after min 21 days use with Pixi mask||||AHI (events/hour)||Standard Deviation|Mean
1413232|NCT01154322|Primary|Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask|Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.|Baseline AHI|Subjects who completed all visits and procedures|||AHI (events/hour)||Standard Deviation|Mean
1413233|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts With Substance Use|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts in which the participant reported using substances before the sex act.|6 months post randomization||||sex acts with substance use|||Number
1413234|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Partners|Self-reported continuous variables to determine number of partners with whom the participant had unprotected (vaginal and/or anal) sex.|6 months post randomization||||unprotected partners||Standard Error|Least Squares Mean
1413235|NCT01154296|Secondary|Sexual Risk Behavior -- # of Partners|Self-reported continuous variables to determine number of partners with whom the participant had (vaginal and/or anal) sex.|6 months post randomization||||partners||Standard Error|Least Squares Mean
1413236|NCT01154296|Secondary|Sexual Risk Behavior -- # of Unprotected Sex Acts|Self-reported continuous variables to determine number of unprotected (vaginal and/or anal) sex acts|6 months post randomization||||unprotected sex acts||Standard Error|Least Squares Mean
1413237|NCT01154296|Secondary|Sexual Risk Behavior -- # of Sex Acts|Self-reported continuous variables to determine number of (vaginal and/or anal) sex acts.|6 months post randomization||||sex acts||Standard Error|Least Squares Mean
1413238|NCT01154296|Primary|STI Incidence|Composite STI incidence (Yes/No) at 6-month follow-up in which a person is considered positive for STIs if they are positive on any tested STI.|6 months post randomization||||participants|||Number
1413239|NCT01154283|Secondary|EuroQol Visual Analogue Scale(VAS)|Quality of life assessed with visual analogue scale. Where the patient is asked to place a mark on a piece of paper with a vertical, scale from 100 at the top to 0 at the bottom of the scale. Where the patient is informed that 100 represents his or her best imaginable health state and 0 is his or her worst imaginable health state.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report quality of life at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete quality of life assessments.|||units on a scale||Standard Deviation|Mean
1413240|NCT01154283|Secondary|Transitional Dyspnea Index|Transitional Dyspnea Index scores patient reported changes in difficulty breathing during each intervention period from -3 (major deterioration) to +3 (major improvement) in three categories: functional impairment, magnitude of task, and magnitude of effort. The total TDI score ranges from -9 to +9.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died and unable to report dyspnea at end of 12 weeks. Two additional patients completed 12 weeks study but did not complete dyspnea assessments.|||units on a scale||Standard Deviation|Mean
1413241|NCT01154283|Secondary|"Patient Preference (Likert Scale) Definitely IPAP-only Probably IPAP-only Uncertain Probably Bi-level Definitely Bi-level"|"Patient Preference of NIPPV mode:~definitely IPAP-only probably IPAP-only uncertain probably Bi-level definitely Bi-level Number of patients who chose definitely or probably are reported."|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)|One patient died before completion of 12 weeks (second intervention) and could not have patient preference assessed.|||participants|||Number
1413469|NCT01153620|Primary|Reduction (log10) in Colony Forming Units|Comparison of the log10 reduction in CFU after 60 minutes of treatment application.|60 minutes|ITT population: comprising all wounds having received the study treatment for any duration (n=61).|||log 10 Colony Forming Units|Participants|Standard Deviation|Mean
1413242|NCT01154283|Primary|Hours of NIPPV Usage|Patients experienced the first intervention period during weeks 1-6 and the second intervention period during weeks 7-12. Patients were given one week to learn how to use the NIPPV equipment at the beginning of each intervention period. Therefore, only the total NIPPV hours used during the last 5 weeks of each intervention period were collected and divided by the number of weeks to obtain the average, weekly hours of NIPPV usage assessed at 6 weeks (first intervention) and 12 weeks (second intervention) for each patient.|Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)||||hours||Full Range|Mean
1413243|NCT01154231|Secondary|Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes|Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.|||percentage|evaluations by physicians|95% Confidence Interval|Number
1413244|NCT01154231|Primary|Number of Administrations Required for Hemostasis for Bleeding Events|Mean number of administrations for hemostasis in replacement therapy for bleeding events.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.|||administrations|dosing for hemostasis|Full Range|Mean
1413245|NCT01154231|Primary|Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy|Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing.|2 years for PTPs, 1 year for PUPs|Efficacy analysis set who recieved at least one administration and had at least one efficacy evaluation was used for this analysis.|||Bleeding events/year||Inter-Quartile Range|Median
1413246|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1413247|NCT01154218|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1413248|NCT01154218|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N = 35' is signifying those participants who were evaluable for this measure at the specified time point for crizotinib CIC fed arm group.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413249|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413250|NCT01154218|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
1413251|NCT01154218|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1413252|NCT01154218|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1413253|NCT01154218|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1413254|NCT01154218|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1413255|NCT01154218|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413256|NCT01154218|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413257|NCT01154166|Secondary|Time to Reinstatement of L-dopa Following a Reduction in Dose Using LOCF|The mean number of days after which the dose of L-dopa was readministered after the reduction in dose was recorded.|Baseline to Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.|||days||Standard Deviation|Mean
1413258|NCT01154166|Secondary|Mean Change From Baseline in the Parkinson's Disease Quality of Life Scores (PDQ39) Using LOCF|The PDQ39 is a 39 item self-administered questionnaire. The questionnaire covers eight domains of health that are reported as adversely affected by patients with PD. Participants were asked to rate responses on a scale from 0 to 4 (“never” to “always”). The overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem). Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points for the indicated domain were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
1413259|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Parkinson's Disease Sleep Scale (PDSS) Total Score Using LOCF|The PDSS uses a series of 15 questions to assess sleep disturbance associated with PD. Participants completed the assessments based on their experiences in the past week by marking a cross on each 10 centimeter (cm) scale (labelled from worst to best state). Responses were quantified by measuring the distance along each line where the cross was placed. The scores for each item ranged from 0 (symptom severe and always experienced) to 10 (symptom free). The maximum cumulative score for the PDSS was thus 150 (free of all symptoms). Change from BL=value at Week 24 minus the BL value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
1413260|NCT01154166|Secondary|Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF|The HAMD-17 is a 17-item scale that is completed by the investigator. Each item was evaluated and scored using either a 5-point scale (e.g., absent, mild, moderate, severe, very severe) or a 3-point scale (e.g., absent, mild, marked). The total HAMD-17 score (sum of the scores of all 17 items) may range from 0 (least severe) to 52 (most severe). Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
1413261|NCT01154166|Secondary|Number of Responders to Study Treatment Using LOCF|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Responders are defined as participants who had at least a 20% reduction from Baseline in awake time spent off and at least a 20% reduction from Baseline in the L-dopa dose."|Baseline to Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||participants|||Number
1413262|NCT01154166|Secondary|Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF|In the event of unacceptable side effects relative to Baseline (e.g., dyskinesias, dystonias [neurological movement disorder]) the dosage of L-dopa was reduced. If there was reduction in the side effects and there was loss of symptom control, the dose of study medication was again increased (reinstated) at subsequent visits. If symptoms could still not be controlled, then L-dopa was reinstated; however, the dose could not exceed the baseline dose.|Week 24|ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method.|||participants|||Number
1413263|NCT01154166|Secondary|Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF|The CGI global improvement scale allows the investigator to rate the participant’s total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be responders.|Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||participants|||Number
1413264|NCT01154166|Secondary|Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF|The UPDRS assesses six features of PD impairment, including Activities of Daily Living (ADL). The total ADL score ranges from 0 to 52, where 0= normal/no symptoms and 52= worst possible case. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
1413265|NCT01154166|Secondary|Mean Change From Baseline in Total Awake Time “on” Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF|Dyskinesias are involuntary twisting, turning movements caused by medication during “on” time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Participants were asked to record the number of awake hours spent ”on” without TD in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent“on”without TD per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.|||hours||Standard Deviation|Mean
1413431|NCT01153711|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
1413266|NCT01154166|Secondary|Mean Change From Baseline in Total Awake Time Spent “on” at Week 24 Using LOCF|"The on state is defined as the state in which the PD symptoms (lack of mobility, tremor, or rigidity) are adequately controlled by the drug. Participants were asked to record the duration of their “on” periods in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent “on” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.|||hours||Standard Deviation|Mean
1413267|NCT01154166|Secondary|Mean Change From Baseline in the Percentage of Awake Time Spent “Off” (ATSO) at Week 24 Using LOCF|"The off state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their “off” periods in 24-hour diary cards prior to each visit on the same 2 days of each relevant week. The total number of awake hours spent “off” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. The percentage of ATSO=ATSO divided by (ATSO + awake time spent on) * 100. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline."|Baseline and Week 24|ITT Population. Data were collected using the LOCF method.|||Percentage of time||Standard Deviation|Mean
1413268|NCT01154166|Secondary|Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF|The UPDRS, a clinician-based rating scale, assesses 6 features of PD impairment: (1) mentation, behavior, and mood; (2) activities of daily living; (3) motor examination; (4) complications of therapy; (5) modified Hoehn and Yahr stage; (6) Schwab and England activities of daily living scale. Assessments were conducted when participants had benefit in regard to mobility, tremor, and rigidity. The total motor score (sum of motor examination) ranges from 0 to 108: 0=normal/no symptoms; 108=worst possible case. Change from BL was calculated as the value at Week 24 minus the value at BL.|Baseline and Week 24 (Visit 13)|ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||scores on a scale||Standard Deviation|Mean
1413269|NCT01154166|Primary|"Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF)"|"The off state is defined as the state in which Parkinson’s Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their “off ” periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent “off” per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value."|Baseline and Week 24 (Visit 13)|Intent-to-treat (ITT) Population: all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. In the LOCF dataset, the last available on-therapy observation for a participant is used to estimate missing data points.|||hours||Standard Deviation|Mean
1413270|NCT01154153|Secondary|The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase|The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0.|From randomization to 43-50 days postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Percentage of days||Standard Deviation|Mean
1413271|NCT01154153|Secondary|Number of Participants Using Rescue Medication|The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study).|From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Participants|||Number
1413272|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Participant|Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Participants|||Number
1413273|NCT01154153|Secondary|Number of Participants by Relief Level as Evaluated by the Physician|Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).|At end of study (43-50 days after randomization)|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Participants|||Number
1413371|NCT01153971|Secondary|FFS - Percentage of Participants With an Event|FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or who dropped out due to AEs were censored at their last assessment date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants|||Number
1413274|NCT01154153|Secondary|Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)|"Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms).~Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase)."|From 8-24 days prerandomization up to 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Score on a scale||Standard Deviation|Mean
1413275|NCT01154153|Primary|Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline|"Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times.~Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis."|1-3 days prerandomization and 6 weeks postrandomization|The per protocol (PP) population included all randomized participants who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.|||Ratio||Full Range|Geometric Mean
1413276|NCT01154140|Secondary|Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities|ALT/AST (Grade[g]1:>ULN-3*ULN,g2:>3-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Alkaline Phosphatase (g1:>ULN-2.5*ULN,g2:>2.5-5*ULN,g3:>5-20*ULN,g4:>20*ULN);Creatinine (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-6*ULN,g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160-250,g3:>250-500,g4:>500mg/dL);bilirubin(total) (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-10*ULN,g4:>10*ULN);hypoglycaemia (g1:<LLN-55,g2:<55-40,g3:<40-30,g4:<30mg/dL);hyperkalemia (g1:>ULN-5.5,g2:>5.5-6,g3:>6-7,g4:>7mmol/L);hypokalemia (g1:<LLN-3,g2:<LLN-3,g3:<3-2.5,g4:<2.5mmol/L);hypermagnesemia (g1:>ULN-3,g3:>3-8,g4:>8mg/dL);hypocalcemia (g1:<LLN-8,g2:<8-7,g3:<7-6,g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5,g3:>12.5-13.5,g4:>13.5mg/dL);hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9,g3:<0.9-0.7,g4:<0.7mg/dL);hyponatremia (g1:<LLN-130,g3:<130-120,g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3-2,g3:<2,g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2,g3:<2-1,g4:<1mg/dL). Participant>=1 abnormality given.|Baseline up to follow up period (up to 72 months)|"Safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. Here, N=participants who were evaluable for this outcome measure. Here, n=participants who were evaluable at specified time points."|||percentage of participants|||Number
1413277|NCT01154140|Secondary|Percentage of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities|Anemia(grade[g]1:Less than[<] Lower limit of normal[LLN] to 10gram per[/] deciliter[g/dL],g2:<10 to 8g/dL,g3:<8g/dL,g4:lifethreatening);platelet (g1:<LLN to 75*10^3/millimeter[mm]^3,g2:<75*10^3/mm^3 to 50*10^3/mm^3,g3:<50*10^3/mm^3 to 25*10^3/mm^3,g4:<25*10^3/mm^3);lymphopenia(g1:<LLN to 8*10^2/mm^3,g2:<8*10^2 to 5*10^2/mm^3,g3:<5*10^2 to 2*10^2/mm^3,g4:<2*10^2/mm^3);neutrophil (Absolute)(g1:<LLN to 15*10^2/mm^3,g2:<15*10^2 to 10*10^2/mm^3,g3:<10*10^2 to 5*10^2/mm^3,g4:<5*10^2/mm^3);white blood cell count(g1:<LLN to 3*10^3/mm^3,g2:<3*10^3 to 2*10^3/mm^3,g3:<2*10^3 to 1*10^3/mm^3,g4:<1*10^3/mm^3);hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.|Baseline up to follow up period (up to 72 months)|Safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle. Here, N=participants who were evaluable for this outcome measure.|||percentage of participants|||Number
1413278|NCT01154140|Secondary|Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)|Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization and date of discharge.|Baseline up to follow up period (up to 72 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percentage of participants|||Number
1413279|NCT01154140|Secondary|Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. VAS component: participants rated their current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health.|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|"The patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment. Here, N signifies participants who were evaluable for this outcome measure."|||units on a scale||95% Confidence Interval|Mean
1413286|NCT01154140|Secondary|Plasma Predose Concentration (Ctrough) of Crizotinib and Its Metabolite PF-06260182|Ctrough is the concentration prior to study drug administration on Day 1 of Cycle 2 onwards. PF-06260182 is the metabolite of Crizotinib.|Predose at Day 1 of Cycle 2, 3 and 5|Pharmacokinetic concentration population included all participants in the safety analysis population who had at least 1 plasma concentration of crizotinib or its metabolite.N=participants evaluable for this measure.Number of participants analyzed(n)=participants evaluable at specified time points.This analysis was performed in crizotinib arm only.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1452227|NCT00835510|Secondary|Mycologic Cure|Negative KOH and fungal culture at day 42|42 days|ITT population|||Participants|||Number
1413280|NCT01154140|Secondary|Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)|QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||units on a scale||95% Confidence Interval|Mean
1413281|NCT01154140|Secondary|Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||units on a scale||95% Confidence Interval|Mean
1413282|NCT01154140|Secondary|Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).|Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)|The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||units on a scale||95% Confidence Interval|Mean
1413283|NCT01154140|Secondary|Time to Deterioration (TTD) in Chest Pain, Dyspnea or Cough|TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Core 30 (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant’s scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment (QLQ-LC13) for pain, dyspnea, or cough or at last visit date prior to crossover for participants randomized to chemotherapy who subsequently crossed over to crizotinib. A 10-point or higher change in the score was perceived by participants as clinically significant. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 (European Organization for the Research and Treatment of Cancer) range from 0 to 100, where higher scores indicate greater symptom severity.|From randomization of treatment up to deterioration while on study treatment (up to 35 months)|The patient reported outcome (PRO) evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.|||months||95% Confidence Interval|Median
1413284|NCT01154140|Secondary|Objective Response Rate (ORR) of Anaplastic Lymphoma Kinase (ALK) Variant Groups Based on IRR|The Response Genetics, Inc. EML4 ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants with confirmed CR or PR according to RECIST v1.1 determined by IRR, by type of ALK gene fusion variant were reported in this outcome measure. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7). Here, n signifies participants who were evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
1413285|NCT01154140|Secondary|Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants|The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements [V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.|28 days prior to day 1 of study treatment|The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).|||percentage of participants|||Number
1413732|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413287|NCT01154140|Secondary|Percentage of Participants With Adverse Events (AEs) According to Maximum Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.|Baseline up to follow up period (up to 72 months)|The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||percentage of participants|||Number
1413288|NCT01154140|Secondary|Percentage of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to follow up period (up to 72 months)|The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||percentage of participants|||Number
1413289|NCT01154140|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to follow up period (up to 72 months)|The safety analysis population included all randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||percentage of participants|||Number
1413290|NCT01154140|Secondary|Time to Extracranial Progression (EC-TTP) Based on IRR|EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
1413291|NCT01154140|Secondary|Time to Intracranial Progression (IC-TTP) Based on IRR|IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
1413292|NCT01154140|Secondary|Time to Progression (TTP) Based on IRR|TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression according to RECIST v1.1 determined by IRR. Objective tumor progression was defined as 20% increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44.|Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
1413300|NCT01154127|Secondary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) on Treatment Day 1|"SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise.~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 1|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||Seconds||95% Confidence Interval|Least Squares Mean
1416381|NCT01127581|Secondary|Incidence of Any Delivery Within 12 Hours||Interval from study drug administration to delivery of neonate within 12 hours|Intention-to-Treat (ITT) Population|||percentage of participants||95% Confidence Interval|Number
1413293|NCT01154140|Secondary|Percentage of Participants With Disease Control at Week 12 Based on IRR|Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.|Week 12|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percentage of participants||95% Confidence Interval|Number
1413294|NCT01154140|Secondary|Time to Tumor Response (TTR) Based on IRR|TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) according to RECIST v1.1 determined by IRR. CR: complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.|Randomization to first documentation of objective tumor response (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here N signifies participants with objective tumor response and were evaluable for this outcome measure.|||weeks||Full Range|Median
1413295|NCT01154140|Secondary|Duration of Response (DR) Based on IRR|DR: time from first documentation of objective tumor response (CR or PR) to first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1 determined by IRR. CR: complete disappearance of all target and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions, disappearance of all non-target lesions. PR: >=30% decrease taking as reference the baseline sum of lesion dimensions. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions. c) PD: 20 % increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 mm or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. Here Overall number of participants analyzed (N) signifies participants with objective tumor response and were evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
1413296|NCT01154140|Secondary|Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR|ORR was defined as percentage of participants with complete response (CR) or partial response (PR) according to RECIST v1.1 determined by IRR. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as greater than or equal to (>=) 30% decrease taking as reference the baseline sum of lesion dimensions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No clear progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percentage of participants||95% Confidence Interval|Number
1413297|NCT01154140|Secondary|Overall Survival Probability at Month 12 and 18|Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.|Month 12, 18|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||percent probability||95% Confidence Interval|Number
1413298|NCT01154140|Secondary|Overall Survival (OS)|OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.|From randomization to death or last date known alive for those not known to have died (up to 72 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
1413299|NCT01154140|Primary|Progression-Free Survival (PFS) Based on IRR|PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date − randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||months||95% Confidence Interval|Median
1413432|NCT01153711|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Hours||Full Range|Median
1413301|NCT01154127|Secondary|Leg Discomfort (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The modified Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of leg discomfort before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||units on a scale||95% Confidence Interval|Least Squares Mean
1413302|NCT01154127|Secondary|Exertional Dyspnea (Borg CR10 Scale) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks Treatment|"The Borg CR10 Scale consists of 12-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 12 indicates maximum breathlessness).~A reduction in this score indicates an improvement. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||units on a scale||95% Confidence Interval|Least Squares Mean
1413303|NCT01154127|Secondary|Specific Airways Conductance (SGaw)|"SGaw is a measure of how hard it is to get air into the lungs, measured by (Sec(-1)*kP). Whole body plethysmography (Bodybox) was used to measure SGaw.~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||litres/(Second*kpa); kpa = kilopascal||95% Confidence Interval|Least Squares Mean
1413304|NCT01154127|Secondary|Slow Vital Capacity (SVC) and Total Lung Capacity (TLC)|"Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation. Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs.~Total Lung Capacity (TLC) is the best vital capacity plus residual volume. Whole body plethysmography (Bodybox) was used to measure SVC and TLC. The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period)."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.|||Litres||95% Confidence Interval|Least Squares Mean
1413305|NCT01154127|Secondary|Peak and Trough (24 h Post Dose) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|"FEV1 is the amount of air that can be exhaled in one second. FEV1 was measured with spirometry conducted according to internationally accepted standards.~FVC is the volume of air that can forcibly be blown out after full inspiration and is used in spirometry tests.~The trough effects of Day 1 treatment are derived from values prior to morning dosing on the next treatment day (Day 2 of the corresponding period).~The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||Litres||95% Confidence Interval|Least Squares Mean
1413306|NCT01154127|Secondary|Inspiratory Capacity (IC) at Rest (1 Hour Post Dose) and at Peak (End of Exercise) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|"IC at peak was observed using spirometry. However, two different methodologies (whole body plethysmography (Bodybox) and spirometry) were used to observe IC at rest.~The analysis of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect."|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment. “n” indicates number of participants with observation at each time-point.|||Litres||95% Confidence Interval|Least Squares Mean
1413307|NCT01154127|Secondary|Isotime Inspiratory Capacity (IC) During Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks of Treatment|Isotime is the last matching timepoint in the submaximal exercise tolerance test (SMETT) at which for both periods the patient has a test result. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting primary the PD assessment.|||Liters||95% Confidence Interval|Least Squares Mean
1413308|NCT01154127|Primary|Exercise Endurance Time During a Sub-maximal Constant-load Cycle Ergometry Test (SMETT) After 3 Weeks (Day 21) of Treatment|SMETT is an exercise procedure where the patient cycles at 80% of the maximum workload (Wmax )value achieved at the Incremental exercise test. During this test, the patient will cycle at a constant load. Exercise endurance time was from commencement of loaded pedaling to stopping exercise. The analysis-of covariance model included the sequence, period, and treatment as fixed factors, the baseline value as covariate and the patient as a random effect.|Day 21|Pharmacodynamics (PD) set consisted of participants who completed at least one treatment period, had an evaluable PD assessment on Day 21 of this period and had no major protocol deviation impacting the primary PD assessment.|||seconds||95% Confidence Interval|Least Squares Mean
1413309|NCT01154101|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) as an Indicator of the Pharmacodynamic Effects of SRT2104|The pharmacodynamic effects of SRT2104 was measured by biomarkers of psoriatic disease activity and/or sirtuin pathway activation (hsCRP and FGF21) in blood samples. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Days 28, 56 and 84|EAS population. Only those participants available at the specified time points were analyzed.|||mg per Liter||Standard Deviation|Mean
1413310|NCT01154101|Secondary|Change From Baseline in Fibroblast Growth Factor 21 (FGF21) as an Indicator of the Pharmacodynamic Effects of SRT2104|The pharmacodynamic effects of SRT2104 was measured by biomarkers of psoriatic disease activity and/or sirtuin pathway activation (hsCRP and FGF21) in blood samples. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Days 28, 56 and 84|EAS population. Only those participants available at the specified time points were analyzed.|||Picogram per milliliter||Standard Deviation|Mean
1413311|NCT01154101|Secondary|Maximum Plasma Concentration (Cmax) of 12 Weeks of Dosing With 250 Milligrams (mg), 500 mg and 1000 mg SRT2104 in the Fed State in Participants|A total of five blood samples (6 mL each) were obtained from each participant at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12), for determination of SRT2104 plasma concentrations. No two samples were separated by less than an hour. One pre-dose sample was collected prior to taking study medication (30 minutes or less before dosing) at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12). A single pharmacokinetic (PK) sample was collected in the time interval of 0.5 to 2 hours post-dose and also 3 to 6 hours post-dose at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12). Two PK samples were collected in the time interval of 6 to 22 hours post dose at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12).|One sample: Pre-dose (30 minutes or less before dosing), One sample: 0.5 to 2 hours post-dose and 3 to 6 hours post-dose and 2 samples 6 to 22 hours post dose, at any Visit 4 (Day 28 or Week 4), Visit 6 (Day 56 or Week 8) or Visit 8 (Day 84 or Week 12)|PK population.|||ng/mL||Standard Deviation|Mean
1413312|NCT01154101|Secondary|Area Under Curve (AUC) of 12 Weeks of Dosing With 0.25 g, 0.5 g and 1.0 g SRT2104 in the Fed State in Participants|A total of five blood samples (6 milliliter [mL] each) were obtained from each participant up to Week 12, for determination of SRT2104 plasma concentrations. No two samples were separated by less than an hour. One pre-dose sample was collected prior to taking study medication (30 minutes or less before dosing) at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12). A single pharmacokinetic (PK) sample was collected in the time interval of 0.5 to 2 hours post-dose and also 3 to 6 hours post-dose at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12). Two PK samples were collected in the time interval of 6 to 22 hours post dose at any Visit 4 (Week 4), Visit 6 (Week 8) or Visit 8 (Week 12).|Pre-dose (30 minutes or less before dosing: 1 sample), 0.5 to 2 hours and 3 to 6 hours post-dose (1 sample), 6 to 22 hours post-dose (2 samples) up to Week 12|PK population which comprised of all participants who received at least one dose of SRT2104 for whom a PK sample was obtained and analyzed.|||Nanogram x hour/milliliter (ng*h/mL)||Standard Deviation|Mean
1413313|NCT01154101|Secondary|Summary of Physician’s Global Assessment (PGA) Score After 4, 8 and 12 Weeks of Exposure|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. Participants in the SRT2104 0.25 g dose group inadvertently used an incorrect version of the PGA scale and thus do not have PGA data available. Participants in the SRT2104 0.25 g dose group inadvertently used an incorrect version of the PGA scale and thus do not have PGA data available.|Weeks 4, 8 and 12|EAS Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1413314|NCT01154101|Secondary|Number of Participants With Clinical Activity in Psoriasis Area and Severity Index (PASI) Score After 4, 8, and 12 Weeks of Exposure|PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score).|Weeks 4, 8 and 12|Efficacy Analysis Set (EAS) population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1413315|NCT01154101|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital sign assessments included measurements of resting heart rate and blood pressure. Potential clinical concern range for systolic blood pressure: <85 and >160 millimeter of mercury (mmHg), for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.|Up to Follow-up (Day 114)|SAF Population.|||Participants|||Count of Participants
1413316|NCT01154101|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Values|12-lead ECG was performed in the rested state with the participant in the supine position with ECG leads on for at least 5 minutes prior to ECG recording. ECGs included PR (PQ), QRS, QT and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Identification of any conduction abnormalities were recorded in the eCRF. If a participant’s QTc intervals were prolonged, then the ECG was done in triplicate with results reported as an average of the three ECGs. Number of participants with abnormal electrocardiogram (ECG) values are presented.|Up to Follow-up (Day 114)|SAF Population.|||Participants|||Count of Participants
1413324|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)|Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1423342|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase|Change from baseline|Baseline and 52 week after||||U/L||Standard Deviation|Mean
1413317|NCT01154101|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|The potential clinical concern range for clinical chemistry parameters were: Albumin:(low: <0.86 gram/Liter x LLN), Calcium:(low: <0.91 millimol/Liter [mmol/L] x LLN and high: >1.06 mmol/L x ULN), Creatinine: (high: >1.3 mmol /L x ULN), Glucose: (low: <0.71 mmol/L x LLN, high: >1.41 mmol/L x ULN), Magnesium: (low: <0.63 mmol/L x LLN, high: >1.03 mmol/L x ULN), Phosphorus: (low: <0.8 mmol/L x LLN, high: >1.14 mmol/L x ULN), Sodium: (low: <0.96 mmol/L x LLN, high: >1.03 mmol/L x ULN), Urea: (high: >1.5 mmol/L x ULN), Gamma glutamyl transferase: (high: >2 International units per L x ULN), Total bilirubin (high: 1.5 x ULN), both alanine amino transferase and aspartate amino transferase (high:≥ 2x ULN Units/L) and Bicarbonate: (low: <18 mmol/L and high: >32 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to Follow-up (Day 114)|SAF Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1413318|NCT01154101|Primary|Number of Participants With Hematology and Coagulation Abnormalities of Potential Clinical Concern|Hematology parameters included hemoglobin, hematocrit, red blood cell count, red cell distribution width, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, white blood cell count and complete white blood cell count differential. Coagulation parameters included activated partial thromboplastin time and prothrombin time/international normalized ratio. The potential clinical concern range for hematology parameters were: white blood cell count (low: <0.67x10^9/Liter x lower limit of normal [LLN] and high: >1.82x10^9/L x upper limit of normal [ULN]), neutrophil count: (low: <0.83x10^9/Liter x LLN), hemoglobin (low: <0.85 gram/Liter x LLN and high: >1.03 gram/Liter x ULN for males and >1.13 gram/Liter x ULN for females), hematocrit with units ratio (high: >1.02 x ULN for males and >1.17 x ULN for females), platelet count (low: <0.67x10^9/Liter x LLN and high >1.57x10^9/Liter x ULN) and lymphocytes (low: <0.81x10^9/Liter x LLN).|Up to Follow-up (Day 114)|SAF Population.|||Participants|||Count of Participants
1413319|NCT01154101|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. The AE category in the data table includes participants who experienced serious or non-serious adverse events or both.|Up to Follow-up (Day 114)|Safety Analysis Set (SAF) population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1413320|NCT01154101|Primary|Assessment of Clinical Activity by Improvement Score (Using Krueger Criteria): Number of Participants With Good or Excellent Improvement Score Based on Histological Assessments of Skin Biopsies After 12 Weeks of Exposure|According to the Krueger criteria, improvement score is classified as Good improvement defined as reduction in epidermal thickness by at least 30% normalized keratinocyte differentiation but most keratinocytes still express K16. Excellent improvement defined as reduction in epidermal thickness to normal or almost normal normalized keratinocyte differentiation and absent keratinocyte expression of K16. No improvement defined as no improvement in epidermal thickness keratinocyte differentiation or K16 expression on keratinocytes. A binomial response was defined for each participant according to whether the participant had an improvement score of “good or excellent improvement” (response=1) or not (response=0). Number of participants with good or excellent improvement score are presented.|12 weeks|The Efficacy Analysis Set (EAS) population comprised of all randomized participants who took at least one dose of study medication, had at least one activity measurement at Baseline, at least one post-Baseline study visit. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1413321|NCT01154036|Secondary|Percent Change From Baseline in Hs-CRP (Phase II)|hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage Change||95% Confidence Interval|Least Squares Mean
1413322|NCT01154036|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)|hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1413323|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)|Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413462|NCT01153633|Secondary|Condition of Wound Bed|Sum of granulation and epithelium (% of wound bed), absolute change from baseline to V6/EoS|12 Weeks|per protocol analysis|||percentage of of wound bed||Standard Deviation|Mean
1413325|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)|Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413326|NCT01154036|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)|Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413327|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)|LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413328|NCT01154036|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)|LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413329|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase II)|TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413330|NCT01154036|Secondary|Percent Change From Baseline in TC/HDL-C Ratio (Phase I)|TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413331|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase II)|Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413332|NCT01154036|Secondary|Percent Change From Baseline in Non-HDL-C (Phase I)|Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413333|NCT01154036|Secondary|Percent Change From Baseline in Apo A-I (Phase II)|Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413334|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)|Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413346|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage of Participants|||Number
1413335|NCT01154036|Secondary|Percent Change From Baseline in Apo B (Phase II)|Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413336|NCT01154036|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)|Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413337|NCT01154036|Secondary|Percent Change From Baseline in HDL-C (Phase II)|HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413338|NCT01154036|Secondary|Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)|HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413339|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase II)|TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage Change||95% Confidence Interval|Least Squares Mean
1413340|NCT01154036|Secondary|Percent Change From Baseline in Triglycerides (TG) (Phase I)|TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1413341|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase II)|TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.|Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413342|NCT01154036|Secondary|Percent Change From Baseline in Total Cholesterol (TC) (Phase I)|TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4|Baseline and Week 6 (end of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I or had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage Change||Standard Deviation|Median
1413343|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)||Week 12 (end of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage of Participants|||Number
1413344|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)||Week 6 (End of Phase I)|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participants who received at least 1 dose of study drug during Phase I, had a baseline measurement for Phase I and had at least 1 measurement after the start of study drug provided during Phase I.|||Percentage of Participants|||Number
1413345|NCT01154036|Secondary|Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)||Week 12 (End of Phase II)|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II and had at least 1 measurement after the start of Phase II|||Percentage of Participants|||Number
1452228|NCT00835510|Secondary|Therapeutic Cure|Subject with clinical and mycological cure at day 7|7 days|ITT Population|||Participants|||Number
1413347|NCT01154036|Secondary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II).|LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).|Baseline (Week 6) and Week 12|Full Analysis Set (FAS). For Phase II this population consisted of all randomized participants who completed Phase I and were not adequately controlled at the end of Phase I, received at least 1 dose of study treatment during Phase II, had a baseline measurement for Phase II or had at least 1 measurement after the start of Phase II|||Percentage Change||Standard Deviation|Median
1413348|NCT01154036|Primary|Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I)|LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).|Baseline and Week 6 (end of Phase I )|Efficacy analyses were performed using the Full Analysis Set (FAS). For Phase I this population consisted of all randomized participant who received at least one dose of study drug during Phase I and had a baseline or at least one measurement available during Phase I|||Percentage Change||Standard Deviation|Median
1413349|NCT01154010|Primary|Inflammation Grade at Day 7|Degree and grade of ocular inflammation based on Standard Uveitis Nomenclature will be assessed at initial visit, Day 3, and Day 7 of use of the PEMF device to assess if the PEMF device decreases the duration and severity of ocular inflammation when used as an adjunctive therapy for anterior uveitis. The results posted here are from day 7. The Standard Uveitis Nomenclature scale ranges from 0 to 4, with 0 indicating a minimal level of ocular inflammation and 4 indicating the maximal level of corneal inflammation.|7 days||||units on a scale||Standard Deviation|Mean
1413350|NCT01153984|Secondary|Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples||Baseline up to approximately 4 years|No participants were analyzed for this outcome as no plasma samples were collected during the study.||||||
1413351|NCT01153984|Secondary|Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations|Participants with NSCLC have tumor associated with EGFR mutations. These mutations occur within EGFR Exons 18-21, which encodes a portion of the EGFR kinase domain.|Day 1|All enrolled participants.|||participants|||Number
1413352|NCT01153984|Secondary|Number of EGFR Positive Participants Classified Based on Smoking Status|Participants were asked: “Have you smoked at least 100 cigarettes in your entire life?” and “Do you now smoke cigarettes every day, some days, or not at all?” Responses were grouped into three categories: Current Smoker, Former Smoker, and Non-Smoker. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of survey, smoked either every day or some days were defined as 'Current smoker'. Participants who reported smoking at least 100 cigarettes in their lifetime and who, at the time of the survey, did not smoke at all were defined as 'Former smoker'. Participants who reported never having smoked 100 cigarettes were defined as 'Non-smoker'.|Day 1|All enrolled participants.|||participants|||Number
1413353|NCT01153984|Secondary|Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1|PD was assessed using RECIST v1.1. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Percentage of participants by localization of PD were reported. Localization included: Left lung inferior lobe; Para-aortic; Left lung upper lobe; Right lung inferior lobe; and Infracranial.|Baseline up to approximately 4 years|All enrolled participants with available data for this outcome.|||percentage of participants|||Number
1413354|NCT01153984|Secondary|Percentage of Participants Who Were Alive One Year After Study Treatment Initiation||Year 1|All enrolled participants with available data for this outcome.|||percentage of participants|||Number
1413355|NCT01153984|Secondary|Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1|CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to baseline.|Baseline up to approximately 4 years|All enrolled participants.|||percentage of participants|||Number
1413356|NCT01153984|Secondary|Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1|Time to disease progression was defined as the time from baseline evaluation to the first date PD was recorded. Participants without progression were censored at the date of last tumor assessment where non-progression was documented. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Baseline up to approximately 4 years|All enrolled participants.|||days||95% Confidence Interval|Median
1413357|NCT01153984|Primary|Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. Analysis was performed using Kaplan-Meier method. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Baseline up to approximately 4 years|All enrolled participants.|||days||95% Confidence Interval|Median
1413358|NCT01153971|Secondary|DR - Time to Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population: only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.|||months||Standard Error|Mean
1413359|NCT01153971|Secondary|DR - Percentage of Participants With an Event|DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.|||percentage of participants|||Number
1413360|NCT01153971|Secondary|Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response|DR data were analyzed using Kaplan-Meier survival analysis. DR was defined for all participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of response until the date of progression or relapse. Participants without relapse or progression were censored at their last assessment date. Participants who died due to tumour were considered in progression. Participants who died for any other cause were censored to the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a response (CR, CRu and PR) at month 1 after the completion of treatment of the induction phase of the study were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1413361|NCT01153971|Secondary|PFS - Time to Event|Progression-free survival was defined as the time from treatment start to the date of documented disease progression. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||months||Standard Error|Mean
1413362|NCT01153971|Secondary|PFS - Percentage of Participants With an Event|Progression-free survival was defined as the time from the date of treatment start to the date of documented disease progression.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants|||Number
1413363|NCT01153971|Secondary|Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free|PFS data were analyzed using Kaplan-Meier survival analysis. PFS was defined as the time from treatment start to the date of documented disease progression. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants||95% Confidence Interval|Number
1413364|NCT01153971|Secondary|DFS - Time to Event|DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.|||months||Standard Error|Mean
1413365|NCT01153971|Secondary|DFS - Percentage of Participants With an Event|DFS was defined for all patients who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (month 7 of the study) and was measured from the time of complete response to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored on the death date.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.|||percentage of participants|||Number
1413366|NCT01153971|Secondary|Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free|DFS data were analyzed using Kaplan-Meier survival analysis. DFS was defined for all participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase (Month 7 of the study) and was measured from the time of CR to the date of relapse. Participants without relapse were censored at their last assessment date. Participants who died due to tumour burden were considered in relapse. Participants who died due to any other causes were censored as of the death date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population; only participants who achieved a complete response (CR/CRu) at month 1 after the completion of treatment of the induction phase were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1413367|NCT01153971|Secondary|OS - Time to Event|Overall survival was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population|||months||Standard Error|Mean
1413368|NCT01153971|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time from first dosage of study drug to the date of death from any cause.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40.|ITT population|||percentage of participants|||Number
1413369|NCT01153971|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive|OS data were analyzed using Kaplan-Meier survival analysis. OS was defined as the time from first dosage of study drug to the date of death from any cause. Reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants||95% Confidence Interval|Number
1413370|NCT01153971|Secondary|FFS - Time to Event|FFS was measured from the date of treatment start to the date of documented disease progression, relapse or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent or dropped out due to AEs were censored at their last assessment date. NOTE: The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||months||Standard Error|Mean
1416382|NCT01127581|Secondary|Incidence of Any Delivery Within 24 Hours||Interval from study drug administration to delivery of neonate within 24 hours|Intention-to-Treat (ITT) Population|||percentage of participants||95% Confidence Interval|Number
1413372|NCT01153971|Secondary|Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death|FFS data were analyzed using Kaplan-Meier survival analysis. FFS was measured from the date of treatment start to the date of documented disease progression, relapse, or death from any cause. Responding participants, participants who were lost to follow up, who withdrew consent, or dropped out due to adverse events (AE) were censored at their last assessment date. The reported data refer to values up to 40 months.|Baseline, Months 1-8, 10-12, 14, 16, 22, 28, 34 and 40|ITT population|||percentage of participants||95% Confidence Interval|Number
1413373|NCT01153971|Secondary|Percentage of Participants Achieving a Response by Response Type and Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7, 11, 16, 22, 28, 34, and 40|ITT population|||percentage of participants|||Number
1413374|NCT01153971|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase|CR: complete disappearance of all symptoms/objective signs of disease (enlarged lymph nodes, hepatomegaly, splenomegaly) for at least 3 months following definitive re-evaluation at end of therapy. For initial bone marrow involvement, clearance of bone marrow documented by biopsy, normalization of blood counts with granulocytes greater than (>)1,500 per microliter (/µL), hemoglobin >12 grams per deciliter (g/dL), platelets >100,000/µL. CRu: disappearance of all symptoms and nearly all measurable lesions, but persistence of some radiologic abnormalities with normalization of all biologic abnormalities; normalization of the performance status for at least 3 months after the definite evaluation of therapy. PR: at least 50 percent (%) reduction of measurable and evaluable lymphoma involvement for at least 4 weeks without occurrence of new manifestations, normalization of blood counts. Participants without evaluation at end of induction/maintenance phase were considered nonresponders.|Baseline, Months 4, 7 (Induction Phase), 11, 16 (Maintenance Phase),22, 28, 34, and 40(Follow-Up Phase)|ITT population|||percentage of participants||95% Confidence Interval|Number
1413375|NCT01153971|Primary|Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date|Percentage of participants who at 2 years from the start of treatment remained free from documented disease progression, relapse, or death. Failure status was based on tumor evaluation performed on Month 28. Participants who did not have a tumor evaluation at Month 28 were counted as failures.|Month 28|ITT population|||percentage of participants||95% Confidence Interval|Number
1413376|NCT01153958|Secondary|Percentage of Participants Cured|Cure was defined as Nugent score less than 7, no symptoms of vaginal irritation (for example, pain, burning, odour or abnormal vaginal discharge). Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated bacterial vaginosis.|1 week post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.|||percentage of participants|||Number
1413377|NCT01153958|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 2 months post-treatment|Safety population included all randomized participants who used the investigational product at least once.|||participants|||Number
1413378|NCT01153958|Secondary|Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment|The grades of Lactobacilli in vaginal discharge were Grade 1 (Normal): Lactobacillus morphotypes predominate; Grade 2 (Intermediate): Mixed flora with some Lactobacilli present, but Gardnerella or Mobiluncus morphotypes also present; Grade 3 (Bacterial Vaginosis): Predominantly Gardnerella and/or Mobiluncus morphotypes, few or absent Lactobacilli.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at the time point.|||participants|||Number
1413379|NCT01153958|Secondary|Change From Baseline in Nugent Score at 2 Months Post-treatment|Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicate bacterial vaginosis.|Baseline and Month 2 post-treatment|FAS population included all enrolled participants who used investigational product. 'n' signifies those participants who were evaluated for this measure at the time point.|||units on a scale||Standard Deviation|Mean
1413380|NCT01153958|Secondary|Percentage of Participants With Relapse 1 Month Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|1 month post-treatment|FAS population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.|||percentage of participants|||Number
1452336|NCT00835003|Secondary|Maternal Fever, Wound Infection, Need of Wound Operative Revision and Antibiotics, Duration of Admission||30 days|||||||
1413381|NCT01153958|Primary|Percentage of Participants With Relapse 2 Months Post-treatment|Relapse: recurrence of the symptoms of bacterial vaginosis [BV] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.|2 months post-treatment|Full analysis set (FAS) population included all enrolled participants who used investigational product. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure.|||percentage of participants|||Number
1413382|NCT01153893|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1413383|NCT01153893|Secondary|Number of Subjects Reporting Unsolicited AEs.|Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 31 days (Days 0-30) after vaccination|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1413384|NCT01153893|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).~Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.~Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1413385|NCT01153893|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.~Solicited local symptoms assessed were pain, redness and swelling.~Any = occurrence of any local symptom regardless of intensity grade.~Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)"|Within 4 days (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1413386|NCT01153893|Secondary|Concentration of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EL.U/mL).|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1413387|NCT01153893|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A.~Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||Titres||95% Confidence Interval|Geometric Mean
1413388|NCT01153893|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8."|One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||Titres||95% Confidence Interval|Geometric Mean
1413399|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Principal Measure as Assessed on the Disability Assessment Scale (DAS)|The investigator assessed 4 areas of disability, hygiene, pain, dressing, and limb posture, using the 4-point DAS (0=No functional disability to 3=Severe disability). Prior to the first dose, the investigator, in consultation with the participant, selected 1functional disability item (which had to have a score of 2 or greater as measured on the DAS, indicating moderate to severe disability) from the 4 areas of disability and assessed it as a principal measure. Change from Baseline at the indicated time points was calculated as the value at Weeks 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1413389|NCT01153893|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1413390|NCT01153893|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1413391|NCT01153893|Primary|Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).|"Grade 3 symptom = severe symptom that prevented normal activity.~Solicited local symptoms assessed were pain, redness and swelling.~Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite.~Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event."|Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1413392|NCT01153841|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|After the first vaccination up to study end (From Month 0 to Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subjects|||Number
1413393|NCT01153841|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) follow-up period after each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Subjects|||Number
1413394|NCT01153841|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Subjects|||Number
1413395|NCT01153841|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 4-day (Days 0-3) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Subjects|||Number
1413396|NCT01153841|Primary|Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited)|The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.|Within the 31-day (Days 0-30) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Subjects|||Number
1413397|NCT01153815|Secondary|GAS Score as Evaluated by the Care Giver or the Participants at the Indicated Time Points|The care giver or participants used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsening, -0=unchanged, +4=very marked improvement) at the indicated time point.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1413398|NCT01153815|Secondary|Global Assessment Scale (GAS) Score as Evaluated by the Physician at the Indicated Time Points|The physician used the GAS to assess response to treatment at each visit after injection. The assessor was the same throughout the study period. GAS scores were assessed by using the 9-point GAS (-4, -3, -2, -1, -0, +1, +2, +3, +4; -4=very marked worsenig, -0=unchanged, +4=very marked improvement) at the indicated time points.|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1452337|NCT00835003|Secondary|Maternal Haemorrhage in ml or Organ Laceration During Caesarean Section.||30 days|||||||
1413400|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8 and 12 for Thumb Flexor Muscle Tone as Measured on the MAS|The investigator, physotherapist, or occupational therapist extended the participant's thumb as quickly as possible to grade the flexor muscle tone. The MAS thumb score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. Only participants with thumb spasticity who received injection in the thumb muscles were evaluated. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1413401|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 6, 8, and 12 for Finger Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's finger as quickly as possible to grade the flexor muscle tone. The MAS finger score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at Week 1, 4, 6, 8, and 12 minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1413402|NCT01153815|Secondary|Number of Participants Classified as Wrist Treatment Responders at All Post-injection Visits|Wrist treatment responders were defined as participants with a decrease in wrist flexor muscle tone of at least one point on the MAS. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension).|Weeks 1, 4, 6, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||participants|||Number
1413403|NCT01153815|Secondary|Change From Baseline at Weeks 1, 4, 8, and 12 for Wrist Flexor Muscle Tone as Measured on the MAS|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.|Baseline (Day 0) and Weeks 1, 4, 8, and 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1413404|NCT01153815|Secondary|Area Under the Curve (AUC) for the Change From Baseline at Weeks 6 and 12 for MAS Wrist Score|The MAS wrist score was assessed by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Mean change from Baseline for the MAS wrist score was calculated as the value at Week 6 and Week 12 minus the value at Baseline. In a graph plotting time points on the horizontal axis (HA) and changes from Baseline on the vertical axis, the area surrounded by the MAS wrist score change curve and the HA was calculated and used as a summary index (AUC) for assessment of the MAS wrist score.|Baseline (Day 0), Week 6, and Week 12|FAS Population. The missing data imputation method was used for analysis.|||scores on a scale||Standard Deviation|Mean
1413405|NCT01153815|Primary|Change From Baseline at Week 6 for Wrist Flexor Muscle Tone as Measured on the Modified Ashworth Scale (MAS)|The investigator, physiotherapist, or occupational therapist extended the participant's wrist as quickly as possible to grade flexor muscle tone. The MAS wrist score was calculated by using the 6-point MAS (0, 1, 1+ [regarded as 1.5], 2, 3, and 4; 0=no increase in muscle tone; 4=affected part[s] rigid in flexion/extension). Change from Baseline at Week 6 was calculated as the value at Week 6 minus the value at Baseline.|Baseline (Day 0) and Week 6|Full Analysis Set (FAS) Population: all randomized and treated participants. The missing data imputation method was used for analysis. For each participant, missing data points were replaced by the mean of the non-missing scores from both treatment groups for that variable at the specific visit.|||scores on a scale||Standard Deviation|Mean
1413406|NCT01153763|Secondary|Number of Participants With Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Levels|LVEF was defined as the percentage of blood pumped out of the left ventricle. Change from Baseline in worst-case post Baseline was presented as no change or any increase and any decrease values. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.|Up to 60 months|All treated Population|||Participants|||Number
1413407|NCT01153763|Secondary|Number of Participants With Increase From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Number of participants with increase from Baseline in SBP and DBP were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as any increase to >=80 and increase to >=100 for DBP and as any increase to >=120 and increase to >=160 for SBP. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst-case post Baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. One participant out of the 92 participants (76 BRAF V600E patients + 16 BRAF V600K patients) did not have SBP and DBP collected after baseline.|Up to 60 months|All treated Population|||Participants|||Number
1413408|NCT01153763|Secondary|Number of Participants With Change From Baseline in Temperature and Pulse Rate|Number of participants with change from Baseline in temperature and pulse rate were evaluated from the first dose of study treatment till discontinuation due to any reason. Change from Baseline in worst-case post Baseline value was presented as decrease to <=35, change to normal or no change and increase to >=38. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period.|Up to 60 months|All treated Population|||Participants|||Number
1413463|NCT01153633|Secondary|Pain|Absolute change (mm VAS) from baseline to V6/EoS. Pain intensity assessed by patient. At each study visit the patients assessed their pain intensity using a 100 mm Visual Analogue Scale (VAS). Thereby 0 mm represented ‘no pain’ and 100 mm ‘worst possible pain’.|12 Weeks|per protocol analysis|||mm||Standard Deviation|Mean
1413409|NCT01153763|Secondary|Number of Participants With Change From Baseline in Clinical Chemistry and Hematology Toxicity Grades|Blood samples were collected from participants for evaluation of change from Baseline in toxicity grades in clinical chemistry and hematology parameters. The clinical chemistry parameters included alkaline phosphatase, Alanine amino transferase (ALT), Aspartate amino transferase (AST), total bilirubin, creatinine, glucose, potassium, magnesium, sodium and phosphorus. The hematology parameters included hemoglobin, total neutrophils, platelets and white blood cells (WBC). Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. The change from Baseline was calculated as visit value minus Baseline value and was presented in the form of worst case post-baseline value which was the maximum toxicity grade for a participant after the first dose of study drug over the treatment period. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Up to 60 months|All treated Population|||Participants|||Number
1413410|NCT01153763|Secondary|Number of Participants With AEs and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on All treated Population which comprised of all participants that receive at least one dose of dabrafenib.|Up to 60 months|All treated Population|||Participants|||Number
1413411|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600K Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using Kaplan-Meier model and median and 95 percent CI was presented.|From the first dose to death due to any cause (up to 60 months)|Secondary Efficacy Population|||Weeks||95% Confidence Interval|Median
1413412|NCT01153763|Secondary|Overall Survival for Participants Who Had a BRAF V600E Mutation|Overall survival is defined as the time from the first dose of study medication until death due to any cause. For participants who did not die, overall survival was censored at the date of last contact. Overall survival was estimated using kaplan-Meier model and median and 95 percent CI was presented.|Up to 60 months|Primary Efficacy Population|||Weeks||95% Confidence Interval|Median
1413413|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Secondary efficacy Population and only those participants who had a CR or PR were analyzed.|Up to 60 months|Secondary Efficacy Population|||Weeks||95% Confidence Interval|Median
1413414|NCT01153763|Secondary|Duration of Response as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|Duration of response for participants with either a CR or PR is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. Duration of response was estimated using Kaplan-Meier model and the median and 95 percent CI was presented. The analysis was performed on Primary efficacy Population and only those participants who had a CR or PR were analyzed.|Up to 60 months|Primary Efficacy Population|||Weeks||95% Confidence Interval|Median
1413415|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent CI. For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.|Up to 60 months|Secondary Efficacy Population|||Weeks||95% Confidence Interval|Median
1413416|NCT01153763|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600E Mutation|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or progression minus date of first dose plus 1 day. Kaplan-Meier model was used to estimate the median and 95 percent confidence interval (CI). For participants who received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was censored at the last adequate assessment. For participants who did not have a documented date of progression or death, PFS was censored at the date of last adequate assessment.|Up to 60 months|Primary Efficacy Population|||Weeks||95% Confidence Interval|Median
1413417|NCT01153763|Secondary|Number of Participants With a Best Overall Response of CR or PR as Assessed by the Investigator and an Independent Reviewer for Participants Who Had a BRAF V600K Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment had to have been performed at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later should have been confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Secondary efficacy analysis Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600K mutation.|Up to 60 months|Secondary Efficacy Population|||Participants|||Number
1413464|NCT01153633|Secondary|Number of Different Microganisms at V6/EoS||12 Weeks|per protocol analysis|||Number of microgasism species||Standard Deviation|Mean
1413418|NCT01153763|Primary|Number of Participants With a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator for Participants Who Had a BRAF V600E Mutation|A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment was required at Week 12 if an initial response was seen at the Week 6 scan. Initial responses (CR/PR) that occured at Week 12 or later were required to be confirmed not less than 4 weeks and not more than 6 weeks after the criteria for response were first met. The analysis was performed on Primary efficacy Population which comprised of all participants who received at least one dose of GSK2118436 (All Treated Participants Population) and had a BRAF V600E mutation.|Up to 60 months|Primary efficacy Population|||Participants|||Number
1413419|NCT01153724|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS|||participants|||Number
1413420|NCT01153724|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who had taken at least 1 dose of trial medication.|||participants|||Number
1413421|NCT01153724|Secondary|Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss)|AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1413422|NCT01153724|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||ng||Geometric Coefficient of Variation|Geometric Mean
1413423|NCT01153724|Secondary|Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)|fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||percentage of olodaterol||Geometric Coefficient of Variation|Geometric Mean
1413424|NCT01153724|Secondary|Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||Hours||Full Range|Median
1413425|NCT01153724|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1413426|NCT01153724|Primary|Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1413427|NCT01153711|Secondary|Assessment of Tolerability by the Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|End of period 1 and end of period 2|TS|||participants|||Number
1413428|NCT01153711|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events.|First administration of trial medication until 6 days after last administration of trial medication|Treated set (TS) - Treated set includes all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.|||participants|||Number
1413429|NCT01153711|Secondary|Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)|AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1413430|NCT01153711|Secondary|Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)|Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||ng||Geometric Coefficient of Variation|Geometric Mean
1413433|NCT01153711|Primary|Maximum Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|PK analysis set with evaluable data for this endpoint.|||Picogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1413434|NCT01153711|Primary|Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)|AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.|Day 8 of period 1 and day 14 of period 2|Pharmacokinetic (PK) analysis set includes all evaluable subjects in the treated set providing at least 1 observation for at least 1 PK endpoint without important protocol violations.|||Picogram*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
1413435|NCT01153698|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality Events During Total Treatment Period|Total treatment period is defined from first enoxaparin administration to 24h after last Pradaxa intake or to 35h after last enoxaparin administration if no switch was performed.|From first enoxaparin administration until 24 hours after last Pradaxa intake ( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated Set|||Number of participants|||Number
1413436|NCT01153698|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last Pradaxa intake|Treated Set (All patients with non-missing information for both, the volume drainage until first dose of Pradaxa and the volume drainage from first dose of Pradaxa and onwards).|||ml||Standard Deviation|Mean
1413437|NCT01153698|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings During Total Treatment Period|Major extra-surgical site bleedings include all major bleedings not occurred at surgical site|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS|||Percentage of participants||95% Confidence Interval|Number
1413438|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Switch Treatment Period|"sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.~Symptomatic DVT is defined as clinically symptomatic venous thromboembolic event and symptomatic non-fatal PE is defined as symptomatic pulmonary embolism"|From last enoxaparin administration until first Pradaxa intake|TS reduced to patients with switch period.|||Percentage of participants||95% Confidence Interval|Number
1413439|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Pre-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.|||Percentage of participants||95% Confidence Interval|Number
1413440|NCT01153698|Secondary|Percentage of Patients With sVTE and All-cause Mortality Events During Total Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal DVT and documented symptomatic non-fatal PE.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS|||Percentage of participants||95% Confidence Interval|Number
1413441|NCT01153698|Secondary|Percentage of Patients With MBE During Pre-switch Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until last enoxaparin administration|TS reduced to patients with pre-switch period.|||Percentage of participants||95% Confidence Interval|Number
1413442|NCT01153698|Secondary|Percentage of Patients With MBE During Total Treatment Period|MBEs were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From first enoxaparin administration until 24 hours after last Pradaxa intake if switch to Pradaxa was performed or to 35 hours after last enoxaparin administration if no switch was performed|TS|||Percentage of participants||95% Confidence Interval|Number
1413443|NCT01153698|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All-cause Mortality Events During the Switch-/ Post-switch Treatment Period|sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From last enoxaparin administration until 24 hours after last Pradaxa intake (planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|TS reduced to patients with switch-/ post-switch period.|||Percentage of participants||95% Confidence Interval|Number
1413444|NCT01153698|Primary|Percentage of Patients With Major Bleeding Events (MBE) During the Switch-/ Post-switch Treatment Period|Major bleeding events were defined according to the modified McMaster criteria. The criteria for MBEs were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation.|From last enoxaparin administration until 24 hours after last Pradaxa intake( planned: knee replacement: Day 10 after surgery, hip replacement:Day 28-35 after surgery)|Treated set (TS) reduced to patients with switch-/ post-switch period. TS includes all patients who received at least one dose of enoxaparin or at least one dose of Pradaxa.|||Percentage of participants||95% Confidence Interval|Number
1413445|NCT01153685|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period|The analysis was performed on the Total Vaccinated Cohort.|||Subjects|||Number
1413446|NCT01153685|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort.|||Subjects|||Number
1413447|NCT01153685|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms.~Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination.~Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination."|Within the 21-day post-vaccination period|The analysis was performed on the Tota Vaccinated Cohort.|||Subjects|||Number
1413448|NCT01153685|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral.|Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)|During a 4-days (Day 0-3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated Cohort on subjects with available results.|||Subjects|||Number
1413449|NCT01153685|Primary|Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains.|Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Fold increase||95% Confidence Interval|Mean
1413450|NCT01153685|Primary|Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains.|A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Subjects|||Number
1413451|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Subjects|||Number
1413452|NCT01153685|Primary|Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains.|A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Subjects|||Number
1413453|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 21 after vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Titer||95% Confidence Interval|Geometric Mean
1413454|NCT01153685|Primary|Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains.|The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane|At Day 0 before vaccination|The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.|||Titer||95% Confidence Interval|Geometric Mean
1413455|NCT01153672|Secondary|Percentage of Patients That Experience Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Up to approximately 5 years||||percentage of participants|||Number
1413456|NCT01153672|Secondary|Overall Survival|Kaplan-Meier survival curves will be used to describe overall survival. Overall survival time will be censored on the last date the patient was known to be alive.|Time elapsed from the first day of study treatment until death, assessed up to approximately 5 years||||months||Full Range|Median
1413457|NCT01153672|Secondary|Progression-free Survival|Kaplan-Meier survival curves will be used to describe progression-free survival. For progression-free survival, patients without documented disease progression or death will be treated as censored observations on the date of the last tumor assessment.|Time elapsed from the first day of study treatment, until disease progression or death, assessed up to approximately 5 years||||months||Full Range|Median
1413458|NCT01153672|Primary|Duration of Response|Duration of response will be summarized for responders.|Up to approximately 5 years||||weeks||Full Range|Median
1413459|NCT01153672|Primary|Rate of Clinical Benefit According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the response rate and the rate of clinical benefit. The radiological (by computed tomography [CT]) response rate of vorinostat will be determined by tumor measurements assessed by modified RECIST criteria.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) assessed by CT, Clinical Benefit was defined as an objective response (complete response [CR], partial response [PR]) or stable disease [SD]). CR=the disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of 1 or more new lesions."|Up to approximately 5 years||||percentage of evaluable participants||90% Confidence Interval|Number
1413460|NCT01153633|Primary|Absolute Change of Target Ulcer From Baseline to Last Visit||12 weeks|per protocol analysis|||square centimeters||Standard Error|Least Squares Mean
1413461|NCT01153633|Primary|Healing of Target Ulcer atV6/EOS|Number of ulcers healed at V6/EOS|12 weeks|per protocol analysis|||ulcers|||Number
1413470|NCT01153581|Primary|Skin Microvascular Responses|"Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as “% max. This is measured with a Laser Doppler probes, which measures volts."|2 months|Women with and without orthostatic intolerance|||Percent of max volts||Standard Error|Mean
1413471|NCT01153581|Primary|Baroreceptor Function|"This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.~Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg."|2 months|Women with low and high orthostatic tolerance|||ms/mm Hg||Standard Error|Mean
1413472|NCT01153581|Primary|Orthostatic Tolerance|We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.|2 months||||mmHg*min||Standard Deviation|Mean
1413473|NCT01153503|Primary|Morphine Consumption|Morphine consumption over the first 24 hours|24 hours post surgery||||mg||Standard Deviation|Mean
1413474|NCT01153425|Secondary|Percentage of Change in Bone Volume Fraction (BVF)|Average fractional content of bone expressed in percent|Change between baseline and 12 months||||Percentage of Change||Standard Deviation|Mean
1413475|NCT01153425|Primary|Percentage of Change in Trabecular Surface-to-curve Ratio|Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C|Change between baseline and 12 months|Mean change in structural and mechanical markers of bone turnover between the two groups.|||Percentage of Change||Standard Deviation|Mean
1413476|NCT01153347|Secondary|Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11- point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413477|NCT01153347|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413478|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413479|NCT01153347|Secondary|Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Q LES-Q-SF)Item 15|The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient’s satisfaction with medication and overall quality of life. The 15th item queries respondents’ satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413480|NCT01153347|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413499|NCT01153321|Secondary|CC16 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CC16 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
1423343|NCT01070784|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and 52 week after||||U/L||Standard Deviation|Mean
1413481|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413482|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413483|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score|A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413484|NCT01153347|Secondary|Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413485|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 14|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 14|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413486|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 12|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 12|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413487|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 10|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 10|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413488|NCT01153347|Secondary|Change in MADRS Total Score From Randomization (Week 8) to Week 9|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to Week 9|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413489|NCT01153347|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)|A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale, the total score can range from 0 to 56. Higher HAM-A scores indicate higher levels of anxiety.|Randomization (Week 8) to end of treatment (Week 16)||||units on a scale||Standard Error|Least Squares Mean
1413490|NCT01153347|Secondary|Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of “Very Much Improved” or “Much Improved” From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1413491|NCT01153347|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413492|NCT01153347|Secondary|Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score|A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413493|NCT01153347|Secondary|Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12, Week 14, Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1413494|NCT01153347|Secondary|Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of patients analyzed|||Number
1413495|NCT01153347|Secondary|Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1413496|NCT01153347|Secondary|Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)|"The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 16|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1413497|NCT01153347|Secondary|Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)|"The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||percentage of participants analyzed|||Number
1413498|NCT01153347|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Randomization (Week 8) to end of treatment (Week 16)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1413500|NCT01153321|Secondary|Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)||up to 47 days (visit 1 to visit 6)||||Participants|||Number
1413501|NCT01153321|Secondary|Number of Participants With Clinically Relevant Changes in Physical Examination||up to 47 days (visit 1 to visit 6)||||Participants|||Number
1413505|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||nmol*h/L||Full Range|Geometric Mean
1413506|NCT01153321|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||nmol*h/L||Full Range|Geometric Mean
1413507|NCT01153321|Secondary|Time to Cmax (Tmax) of AZD2423 at Steady State|Steady state PK profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||hours||Full Range|Median
1413508|NCT01153321|Secondary|Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State|Steady state pharmacokinetic (PK) profile measured on Day 10|Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose|All 22 patients who received AZD2423 provided at least one plasma sample and were included in the PK analysis although only 21 patients were included in the evaluation of PK at day 10, one patient had been discontinued due to an AE.|||nmol/L||Full Range|Geometric Mean
1413509|NCT01153321|Secondary|Neutrophils in Blood (Post-LPS Challenge)|Neutrophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413510|NCT01153321|Secondary|Neutrophils in Blood (Pre-LPS Challenge)|Neutrophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413511|NCT01153321|Secondary|Monocytes in Blood (Post-LPS Challenge)|Monocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413512|NCT01153321|Secondary|Monocytes in Blood (Pre-LPS Challenge)|Monocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413513|NCT01153321|Secondary|Lymphocytes in Blood (Post-LPS Challenge)|Lymphocytes in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413514|NCT01153321|Secondary|Lymphocytes in Blood (Pre-LPS Challenge)|Lymphocytes in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413515|NCT01153321|Secondary|Eosinophils in Blood (Post-LPS Challenge)|Eosinophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413516|NCT01153321|Secondary|Eosinophils in Blood (Pre-LPS Challenge)|Eosinophils in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413517|NCT01153321|Secondary|Basophils in Blood (Post-LPS Challenge)|Basophils in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413518|NCT01153321|Secondary|Basophils in Blood (Pre-LPS Challenge)|Basophils in blood pre-LPS challenge (Day 10)|day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413519|NCT01153321|Secondary|CC16 Concentration in Blood (Post-LPS Challenge)|CC16 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.|||ng/mL||Standard Error|Least Squares Mean
1413520|NCT01153321|Secondary|CC16 Concentration in Blood (Pre-LPS Challenge)|CC16 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Three patients had missing observations.|||ng/mL||Standard Error|Least Squares Mean
1413733|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413521|NCT01153321|Secondary|SP-D Concentration in Blood (Post-LPS Challenge)|SP-D concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
1413522|NCT01153321|Secondary|SP-D Concentration in Blood (Pre-LPS Challenge)|SP-D concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
1413523|NCT01153321|Secondary|TNF-α Concentration in Blood (Post-LPS Challenge)|TNF-α concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413524|NCT01153321|Secondary|TNF-α Concentration in Blood (Pre-LPS Challenge)|TNF-α concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413525|NCT01153321|Secondary|IL-8 Concentration in Blood (Post-LPS Challenge)|IL-8 concentration in blood post-LPS challenge (Day 11)|day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413526|NCT01153321|Secondary|IL-8 Concentration in Blood (Pre-LPS Challenge)|IL-8 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413527|NCT01153321|Secondary|IL-6 Concentration in Blood (Post-LPS Challenge)|IL-6 concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413528|NCT01153321|Secondary|IL-6 Concentration in Blood (Pre-LPS Challenge)|IL-6 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413529|NCT01153321|Secondary|IL-1β Concentration in Blood (Post-LPS Challenge)|IL-1β concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413530|NCT01153321|Secondary|IL-1β Concentration in Blood (Pre-LPS Challenge)|IL-1β concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413531|NCT01153321|Secondary|CCL2 Concentration in Blood (Post-LPS Challenge)|CCL2 concentration in blood post-LPS challenge (Day 11).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413532|NCT01153321|Secondary|CCL2 Concentration in Blood (Pre-LPS Challenge)|CCL2 concentration in blood pre-LPS challenge (Day 10)|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||pg/mL||Standard Error|Least Squares Mean
1413533|NCT01153321|Secondary|SAA Concentration in Blood (Post-LPS Challenge)|SAA concentration in blood post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
1413534|NCT01153321|Secondary|SAA Concentration in Blood (Pre-LPS Challenge)|SAA concentration in blood pre-LPS challenge (Day 10).|Day 10|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||ng/mL||Standard Error|Least Squares Mean
1413535|NCT01153321|Secondary|SP-D Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge SP-D concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||ng/mL||Standard Error|Least Squares Mean
1413536|NCT01153321|Secondary|RANTES Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge RANTES concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
1413567|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with HIV-1 RNA results at Week 144.|||log10 copies/mL||Standard Deviation|Mean
1413537|NCT01153321|Secondary|IL-8 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL 8 concentration in BAL. LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
1413538|NCT01153321|Secondary|IL-6 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-6 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
1413539|NCT01153321|Secondary|IL-1β Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge IL-1β concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
1413540|NCT01153321|Secondary|CCL2 Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge CCL2 concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
1413541|NCT01153321|Secondary|TNF α Concentration in BAL (Post-LPS Challenge)|Post-LPS challenge TNF α concentration in BAL (Day 11). LPS challenge and post-LPS challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. One patient had missing observations.|||pg/mL||Standard Error|Least Squares Mean
1413542|NCT01153321|Secondary|Macrophages in BAL (Post-LPS Challenge)|Post-LPS challenge macrophage differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Deviation|Least Squares Mean
1413543|NCT01153321|Secondary|Neutrophils in BAL (Post-LPS Challenge)|Post-LPS challenge neutrophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413544|NCT01153321|Secondary|Lymphocytes in BAL (Post-LPS Challenge)|Post-LPS challenge lymphocyte differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413545|NCT01153321|Secondary|Eosinophils in BAL (Post-LPS Challenge)|Post-LPS challenge eosinophil differential in BAL. LPS challenge and post-challenge BAL conducted at right middle lobe.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Five patients had missing observations.|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413546|NCT01153321|Secondary|Biopsy Epithelium Grade (Post-LPS Challenge)|Biopsies (from right middle lobe) were assessed for routine histopathology. Epithelial morphology was graded on subjective scale from 1 to 5. 1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.|||Units on a scale||Standard Error|Least Squares Mean
1413547|NCT01153321|Secondary|Biopsy PAS Reaction Grade (Post-LPS Challenge)|Biopsies stained using PAS method. Graded on subjective scale (1=normal; 2=PAS positive cell hypertrophy; 3=PAS positive cell hyperplasia; 4=Metaplasia with PAS positive cells throughout mucosa; 5=Metaplasia and/or squamous plates with loss of PAS positive cells).|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Thirteen patients had missing observations.|||Units on a scale||Standard Error|Least Squares Mean
1413548|NCT01153321|Secondary|CD3+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
1413549|NCT01153321|Secondary|CD45+ in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
1413568|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with HIV-1 RNA results at Week 132.|||log10 copies/mL||Standard Deviation|Mean
1413550|NCT01153321|Secondary|Total Macrophages in Biopsy Sample (Post-LPS Challenge)|Post-LPS challenge data (Day 11). Post-LPS challenge biopsies taken from right middle lobe. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
1413551|NCT01153321|Secondary|Total Neutrophils in Biopsy Sample (Post-LPS Challenge)|Pre-challenge = Day 11. Biopsies taken from left lingula. Cells counted in subepithelium.|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge. Six patients had missing observations.|||cells/mm^2||Standard Error|Least Squares Mean
1413552|NCT01153321|Primary|Absolute Monocyte Count in BAL Post-LPS Challenge|Monocyte count in BAL post-LPS challenge (Day 11)|Day 11|Thirty-nine patients were included in the efficacy analysis set. Five patients were excluded because they did not have sufficient data to be included in the primary outcome analysis. Four discontinued and one did not complete LPS challenge|||x10^4 cells/mL||Standard Error|Least Squares Mean
1413553|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.|Week 144|All participants with CD4+ cell count measurements at Week 144 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413554|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.|Week 132|All participants with CD4+ cell count measurements at Week 132 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413555|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.|Week 120|All participants with CD4+ cell count measurements at Week 120 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413556|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.|Week 108|All participants with CD4+ cell count measurements at Week 108 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413557|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.|Week 96|All participants with CD4+ cell count measurements at Week 96 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413558|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.|Week 84|All participants with CD4+ cell count measurements at Week 84 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413559|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.|Week 72|All participants with CD4+ cell count measurements at Week 72 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413560|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.|Week 60|All participants with CD4+ cell count measurements at Baseline are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413561|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.|Week 48|All participants with CD4+ cell count measurements at Week 48 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413562|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.|Week 36|All participants with CD4+ cell count measurements at Week 36 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413563|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.|Week 24|All participants with CD4+ cell count measurements at Week 24 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413564|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.|Week 12|All participants with CD4+ cell count measurements at Week 12 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413565|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.|Week 4|All participants with CD4+ cell count measurements at Week 4 are included.|||CD4+ cells/μL||Standard Deviation|Mean
1413566|NCT01153269|Primary|CD4 Cell Count|The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.|Baseline|All participants with CD4+ cell count measurements at Baseline are included.|||CD4+ cells/μL||Standard Deviation|Mean
1416383|NCT01127581|Secondary|Incidence of Vaginal Delivery Within 12 Hours||Interval from study drug administration to vaginal delivery within 12 hours|Intention-to-Treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
1413569|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with HIV-1 RNA results at Week 120.|||log10 copies/mL||Standard Deviation|Mean
1413570|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with HIV-1 RNA results at Week 108.|||log10 copies/mL||Standard Deviation|Mean
1413571|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with HIV-1 RNA results at Week 96.|||log10 copies/mL||Standard Deviation|Mean
1413572|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with HIV-1 RNA results at Week 84.|||log10 copies/mL||Standard Deviation|Mean
1413573|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with HIV-1 RNA results at Week 72.|||log10 copies/mL||Standard Deviation|Mean
1413574|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with HIV-1 RNA results at Week 60.|||log10 copies/mL||Standard Deviation|Mean
1413575|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with HIV-1 RNA results at Week 48.|||log10 copies/mL||Standard Deviation|Mean
1413576|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with HIV-1 RNA results at Week 36.|||log10 copies/mL||Standard Deviation|Mean
1413577|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with HIV-1 RNA results at Week 24.|||log10 copies/mL||Standard Deviation|Mean
1413578|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with HIV-1 RNA results at Week 12.|||log10 copies/mL||Standard Deviation|Mean
1413579|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with HIV-1 RNA results at Week 4.|||log10 copies/mL||Standard Deviation|Mean
1413580|NCT01153269|Primary|Viral Load|The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with HIV-1 RNA results at Baseline.|||log10 copies/mL||Standard Deviation|Mean
1413581|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.|Week 144|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 144.|||U/liter||Standard Deviation|Mean
1413582|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.|Week 132|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 132.|||U/liter||Standard Deviation|Mean
1413583|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.|Week 120|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 120.|||U/liter||Standard Deviation|Mean
1413584|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.|Week 108|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 108.|||U/liter||Standard Deviation|Mean
1413585|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.|Week 96|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 96.|||U/liter||Standard Deviation|Mean
1414050|NCT01148836|Primary|Left Ventricular End Diastolic Volume|Amount of blood in ventricle at end of diastole|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||ml||Standard Deviation|Mean
1413586|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.|Week 84|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 84.|||U/liter||Standard Deviation|Mean
1413587|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.|Week 72|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 72.|||U/liter||Standard Deviation|Mean
1413588|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.|Week 60|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 60.|||U/liter||Standard Deviation|Mean
1413589|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.|Week 48|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 48.|||U/liter||Standard Deviation|Mean
1413590|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.|Week 36|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 36.|||U/liter||Standard Deviation|Mean
1413591|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.|Week 24|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.|||U/liter||Standard Deviation|Mean
1413592|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.|Week 12|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.|||U/liter||Standard Deviation|Mean
1413593|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.|Week 4|Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.|||U/liter||Standard Deviation|Mean
1413594|NCT01153269|Primary|Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters|The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.|Baseline|Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.|||U/liter||Standard Deviation|Mean
1413595|NCT01153009|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline SDS total score-by-week as fixed effects.|Baseline and Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1413596|NCT01153009|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
1413597|NCT01153009|Secondary|Change From Baseline in MADRS Total Score at Week 8 in Participants With Baseline Hamilton Anxiety Scale (HAM-A) Total Score ≥20|"The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.~HAM-A is a 14 item rating scale to quantify anxiety severity rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56, where lower scores indicate mild severity."|Baseline and Week 8|Full analysis set patients with a HAM-A Baseline score ≥20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1416683|NCT01124643|Secondary|Change From Baseline in Albumin/Creatinine (A/Cr) Ratio||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||Ratio||Standard Deviation|Mean
1413598|NCT01153009|Secondary|Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) ANCOVA with treatment, center, week, treatment-by-week interaction, Baseline Clinical Global Impression Scale-Severity of Illness (CGI-S) score-by-week as fixed effects.|Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1413599|NCT01153009|Secondary|Percentage of Participants With a MADRS Response at Week 8|Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 8|Full analysis set, last observation carried forward was used.|||percentage of participants|||Number
1413600|NCT01153009|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) analysis of covariance (ANCOVA) with treatment, center, week, treatment-by-week interaction, Baseline MADRS total score-by-week as fixed effects.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1413601|NCT01152996|Secondary|Change From Baseline in SDS Family Life/Home Responsibilities Subscale|The change between the Sheehan Disability family life/home responsibilities subscale score at each assessed visit and family life/home responsibilities subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
1413602|NCT01152996|Secondary|Change From Baseline in SDS Social Life Subscale|The change between the Sheehan Disability social life subscale score at each assessed visit and social life subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
1413603|NCT01152996|Secondary|Change From Baseline in SDS Work/School Subscale|The change between the Sheehan Disability work/school subscale score at each assessed visit and work/school subscale score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely). Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
1413604|NCT01152996|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score|The change between the SDS total score at each assessed visit and the total score collected at baseline. The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment.|Baseline and Weeks 12, 24, 36, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
1413605|NCT01152996|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|"The change between CGI-S score at each assessed visit and CGI-S score at baseline. The CGI-S assesses the clinician’s impression of the subject’s current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill). Higher scores indicate greater severity of illness."|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
1413606|NCT01152996|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The change between HAM-A score at each assessed visit and HAM-A score at baseline. HAM-A is a 14 item rating scale to quantify anxiety symptomatology severity (i.e., anxious mood, tension, fear, insomnia, etc.) rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 4, 24, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
1413607|NCT01152996|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The change between MADRS total score at each assessed visit and MADRS score at baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52|Safety set, observed cases (OC)|||units on a scale||Standard Deviation|Mean
1413666|NCT01152450|Secondary|Peak FVC Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
1413608|NCT01152996|Primary|Treatment-Emergent Adverse Events Leading to Study Discontinuation|Treatment-emergent adverse events are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set|||participants|||Number
1413609|NCT01152996|Primary|Number of Participants With Serious Treatment-Emergent Adverse Events|Serious treatment-emergent adverse events (serious-TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A serious-TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered serious adverse events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|Over the 52 week period|Safety set|||participants|||Number
1413610|NCT01152996|Primary|Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.|Over the 52 week period|Safety set|||participants|||Number
1413611|NCT01152814|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using the PP dataset.|||Percentage of participants||95% Confidence Interval|Number
1413612|NCT01152814|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using the PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
1413613|NCT01152814|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis.|||Number of participants|||Number
1413614|NCT01152814|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violation.|||Percentage of participants||95% Confidence Interval|Number
1413615|NCT01152788|Secondary|Safety and Toxicity Profile (Participants With Grade 3 4 5 Adverse Event)|To determine the safety and toxicity profile of rIL-21 and dacarbazine in patients with chemotherapy and immunotherapy-naive metastatic or recurrent malignant melanoma. Adverse events were measured according to the Common Terminology Criteria version 4.0 for Adverse Events. Number of patients with worst adverse event of grade 3 4 or 5 were counted for both rIL-21 and Dacarbazine arms.|Over study period, up to 22 months||||participants|||Number
1413616|NCT01152788|Secondary|Overall Survival|For patients who have died, overall survival is calculated in months from the day of randomization to date of death. Otherwise, survival is censored at the last day the patient is known alive.|From randomization to death of any cause, up to 22 months||||months||95% Confidence Interval|Median
1413617|NCT01152788|Secondary|Response Rate|Tumour response is defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes must have short axis measures < 10 mm (Note: continue to record the measurement even if < 10 mm and considered CR). Residual lesions (other than nodes < 10 mm) thought to be non-malignant should be further investigated (by cytology or PET scans) before CR can be accepted. Confirmation of complete response is not required in this randomized study. Partial Response (PR): At least a 30% decrease in the sum of measures (longest diameter for tumour lesions and short axis measure for nodes) of target lesions, taking as reference the baseline sum of diameters. Confirmation of partial response is not required in this randomized study. Overall Response (OR) = CR + PR.|From the start of study treatment until the end of treatment (before disease progression)||||percentage of participants||95% Confidence Interval|Number
1413662|NCT01152450|Secondary|FVC Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
1413618|NCT01152788|Primary|Progression Free Survival|Progression free survival is defined as the time from randomization to the time of the first documented progression event or death by any cause. A patient who stops treatment with study drug and goes on to receive alternative therapy prior to documentation of disease progression, will be censored at the date alternative therapy began. If a patient has not progressed or received alternative therapy, progression free survival (PFS) will be censored at the date of the last disease assessment.|From randomization to progression or death, up to 22 months|treated population|||years||95% Confidence Interval|Median
1413619|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 12 Months|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|12 months|Seven participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
1413620|NCT01152697|Secondary|Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 12 Months|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate better outcomes.|12 months|Six participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
1413621|NCT01152697|Secondary|Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 12 Months|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|12 months|Six participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
1413622|NCT01152697|Secondary|Treatment Adherence Score as Measured at 12 Months|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|12 months|Seven participants were administered and completed this measure at 12 months.|||Percentage of doses||Standard Deviation|Mean
1413623|NCT01152697|Secondary|Days Homeless Out of the Previous 6 Months as Measured at 12 Months|Subjects will be asked how many days they have been homeless|12 months|Six participants were administered and completed this measure at 12 months.|||days||Standard Deviation|Mean
1413624|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 12 Months|"Satisfaction will be measured by a seven item inventory taken by the participant.~Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|12 months|Six participants were administered and completed this measure at 12 months.|||units on a scale||Standard Deviation|Mean
1413625|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 12 Months|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-12 months|Six participants were administered and completed measurement with the SOFAS at 12 months. Only data for these participants was analyzed for change from baseline to 12 months.|||units on a scale||Standard Deviation|Mean
1413626|NCT01152697|Secondary|Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 12 Months|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.~Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|12 months|12 participants were administered and completed measurement with the CGI at 12 months.|||units on a scale||Standard Deviation|Mean
1413627|NCT01152697|Secondary|Frequency of Health Resource Use in the Past 3 Months as Measured at 25 Weeks|The frequency of health resource use will be measured through interview of the participant.|25 weeks|17 participants were administered and completed this measure at week 25.|||days||Standard Deviation|Mean
1413628|NCT01152697|Secondary|Change in Schizophrenia and Schizoaffective Disorder Symptom Severity Scale as Measured by the Positive and Negative Syndrome Scale (PANSS) at 25 Weeks|"The PANSS (Kay, Fiszbein, & Opler 1987) was created to assess both the positive and negative symptoms of schizophrenia such as hallucinations and emotional withdrawal, respectively. The scale rates 30 symptoms on a scale from 1 (absent) to 7 (extreme) and has been shown to limit bias between the assessment of positive and negative symptoms, providing a broad but balanced spectrum of the illness.~There are three subscales: positive symptoms, negative symptoms, general psychopathology. Potential responses to Items on all subscales range from 1 (absent) to 7 (extreme). Lower scores indicate lower symptoms and, therefore, better outcomes. Higher scores indicate more presence of symptoms and, therefore, worse outcomes.~Subscales are combined to produce a total score, which is summed from all of the subscales. Lower total scores indicate lower symptoms and, therefore, better outcomes. Higher total scores indicate more presence of symptoms and, therefore, worse outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the PANSS at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
1413629|NCT01152697|Secondary|Treatment Satisfaction as Measured by the Participant Acceptability and Satisfaction Questionnaire at 25 Weeks|"Satisfaction will be measured by a seven item inventory taken by the participant.~Scale ranges from 1 (Strongly Agree) to 5 (Strongly Disagree). Lower scores indicate better outcomes, while higher scores indicate worse outcomes. The highest possible score is 35."|25 weeks|17 participants were administered and completed this measure at week 25.|||units on a scale||Standard Deviation|Mean
1413630|NCT01152697|Secondary|Change in Social and Occupational Functioning Scale (SOFAS) as Measured at 25 Weeks|Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning). The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995). The reliability of the GAF ranges from 0.62-0.82. Higher scores indicate improved outcomes.|Baseline-25 weeks|17 participants were administered and completed measurement with the SOFAS at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
1413631|NCT01152697|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impressions (CGI) at 25 Weeks|"Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 (Guy 1976) Lower scores indicate improved outcomes. Higher scores indicate worse outcomes.~Illness scale: 1 - 7 (1 = Normal/not at all ill ; 7 = Among the most extremely ill patients) Global improvement scale: 1 - 7 (1 = Very much improved ; 7 = Very much worse)"|Baseline-25 weeks|17 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change at week 25.|||units on a scale||Standard Deviation|Mean
1413632|NCT01152697|Secondary|Change in Serious Mental Illness Severity Score as Measured by the Brief Psychiatric Rating Scale (BPRS) at 25 Weeks|"The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that measures major psychotic and non-psychotic symptoms in individuals with SMI. The 18-item BPRS is well-validated and is perhaps the most researched instrument in psychiatry. Reliability coefficients are reported to be in the range of 0.56-0.87.~Scale Range: 18-126 Lower scores represent improved outcomes."|Baseline-25 weeks|19 participants were administered and completed measurement with the BPRS at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
1413633|NCT01152697|Secondary|Frequency of Health Resource Use Throughout Months 10, 11, and 12|The frequency of health resource use will be measured through interview of the participant.|Month 1-3, Month 10-12|Three participants were administered and completed this measurement at 12 months. Only data for these participants was analyzed for changes.|||days||Standard Deviation|Mean
1413634|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks|Nineteen item inventory taken by the participant with Scale Range:0-19. Lower scores indicate improved outcomes.|Baseline-25 weeks|19 participants were administered and completed measurement with the AMQ at week 25. Only data for these participants was analyzed for change from baseline to week 25. Lower scores indicate improved outcomes.|||units on a scale||Standard Deviation|Mean
1413635|NCT01152697|Primary|Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks|Four item inventory taken by participant with Scale Range: 0-4. Lower scores indicate improved outcomes.|Baseline-25 weeks|16 participants were administered and completed measurement with the Morisky Medication Rating Scale at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
1413636|NCT01152697|Primary|Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks|Ten item inventory taken by the participant with a Scale Range: 0-10. Higher scores indicate improved outcomes.|Baseline-25 weeks|15 participants were administered and completed measurement with the DAI at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||units on a scale||Standard Deviation|Mean
1413637|NCT01152697|Primary|Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks|A total treatment adherence score will calculated as a proportion of medications taken as reported from the participant, and evidenced by pill counts and documented medication injections.|Baseline-25 weeks|17 participants were administered and completed measurement of their Treatment Adherence scores at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||Percentage of doses||Standard Deviation|Mean
1413638|NCT01152697|Primary|Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks|Subjects will be asked how many days they have been homeless|Baseline-25 weeks|26 participants were asked how many days they were homeless at week 25. Only data for these participants was analyzed for change from baseline to week 25.|||days||Standard Deviation|Mean
1413639|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in the Pittsburgh Sleep Quality Index (PSQI) in Women After 6 Months, as Compared to Baseline.|"Pittsburgh Sleep Quality Index (PSQI) Questionnaire is a validated questionnaire that assesses the quality and quantity of sleep and sleep disorders.This survey is designed to identify “good” and “poor” sleepers and has a score scale that ranges from 0-21 with 0 being good quality of sleep and 21 being poor quality of sleep and/or indicating as having a sleep disorder. A more positive mean change in the PSQI over time indicates a worsening of sleep. A more negative mean change in the PSQI over time indicates an improvement in sleep."|Baseline and 6 months|intention to treat|||units on a scale||Standard Deviation|Mean
1413640|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Sexual Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
1413641|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Bone Density in Women After 6 Months, as Compared to Baseline.|The mean change in bone mineral density (BMD), represented by T-scores, was assessed by calcaneal ultrasound in women taking melatonin (3 mg) or placebo nightly at baseline and after 6 months. A T-score is a comparison of a subject's BMD to that of a healthy 30 year old female of the same ethnicity. The more negative the T-score, the worse the BMD. Osteoporosis or brittle bone disease is defined as a T-score -2.5 or less. A more negative mean change in a T-score would indicate a worsening of BMD. A more positive mean change in a T-score would indicate an improvement of BMD.|Baseline and 6 months|intention to treat|||T-score||Standard Deviation|Mean
1413663|NCT01152450|Secondary|Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS|||L/min||Standard Error|Mean
1413664|NCT01152450|Secondary|Individual FVC Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
1413642|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Psychosocial Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
1413643|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Type-1 Collagen Cross-linked N-telopeptide (NTX) Levels in Women After 6 Months, as Compared to Baseline.|Type-1 collagen cross-linked N-telopeptide (NTX) levels were measured in the serum of women at baseline and after taking placebo or melatonin (3 mg) nightly for 6 months. NTX, reported as bone collagen equivalents (BCE), is released from bone due to the actions of osteoclasts or bone breakdown cells. A more positive mean change in NTX levels (6 months - baseline) could result in a worsening of bone mineral density due to an increase in bone breakdown whereas a more negative mean change in NTX levels could result in an improvement in bone mineral density due to a decrease in bone breakdown.|Baseline and 6 months|intention to treat|||nM BCE||Standard Deviation|Mean
1413644|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Vasomotor Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
1413645|NCT01152580|Secondary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Menopause-Specific Quality of Life (MENQOL) Physical Domain Scores in Women After 6 Months, as Compared to Baseline.|"Menopause-Specific Quality of Life (MENQOL) questionnaires were administered to women at baseline and after 6 months of taking placebo or melatonin nightly. The MENQOL is a validated questionnaire that measures 4 domains of menopause quality of life in women: physical, vasomotor, psychosocial and sexual with each domain having a scale of not bothered (score 0) or bothered ranging from 1(not too bothered) to 6 (really bothered). A more negative mean change for each of the MENQOL domain scores indicates an improvement of these symptoms and a more positive value a worsening of symptoms."|Baseline and 6 mos|intention to treat|||units on a scale||Standard Deviation|Mean
1413646|NCT01152580|Primary|The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline|Osteocalcin is a measure of osteoblast activity because it is secreted from osteoblasts. Osteocalcin levels were measured in the serum of women at baseline and after 6 months of taking placebo or melatonin (3 mg) and the data are reported as ng/mL. Osteoblasts are bone-forming cells so a more positive mean change in osteoblast activity over time (6 months - baseline) could indicate an improvement in bone mineral density. A more negative mean change in osteocalcin levels over time (6 months - baseline) could indicate a worsening of bone mineral density.|Baseline and 6 months|intention to treat|||ng/mL||Standard Deviation|Mean
1413647|NCT01152554|Secondary|Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)|A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
1413648|NCT01152554|Secondary|Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score|The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
1413649|NCT01152554|Secondary|Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score|Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
1413665|NCT01152450|Secondary|Individual FEV1 Over Time (at Each Timepoint at Visits) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
1413682|NCT01152385|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||mg/dL||Standard Deviation|Mean
1413650|NCT01152554|Secondary|Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.|Randomization (Week 0) to end of treatment (Week 52)|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||units on a scale||Standard Deviation|Mean
1413651|NCT01152554|Secondary|Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52|"The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 52|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||percentage of patients analyzed|||Number
1413652|NCT01152554|Secondary|Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24|"The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20.~A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms."|Week 12 to Week 24|Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.|||percentage of participants analyzed|||Number
1413653|NCT01152554|Primary|Frequency of Patients Experiencing Serious Adverse Events (SAEs)|The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.|||percentage of participants analyzed|||Number
1413654|NCT01152554|Primary|Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.|||percentage of participants analyzed|||Number
1413655|NCT01152554|Primary|Frequency of Patients Experiencing at Least One Adverse Event (AE)|The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.|Randomization (Week 0) to end of the follow-up period (Week 54)|Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.|||percentage of participants analyzed|||Number
1413656|NCT01152450|Secondary|Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Assessed by the patient's electronic diary (eDiary incorporated in the AM2+ device), obtained during the last week of each period of randomised treatment.|Baseline and during week 4|FAS|||Night awakenings||Standard Error|Mean
1413657|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS|||Puffs||Standard Error|Mean
1413658|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS|||Puffs||Standard Error|Mean
1413659|NCT01152450|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared.|Baseline and during week 4|FAS|||Puffs||Standard Error|Mean
1413660|NCT01152450|Secondary|PEF Variability Response (Last Week on Treatment)|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent (weekly means obtained during the last week of each period of randomised treatment will be compared).|Baseline and during week 4|FAS|||Percent||Standard Error|Mean
1413661|NCT01152450|Secondary|PEF Area Under the Curve 0-24 Hours (AUC0-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres/min.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L/min||Standard Error|Mean
1413683|NCT01152385|Secondary|Percentage Change in Triglycerides||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
1413667|NCT01152450|Secondary|FVC Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
1413668|NCT01152450|Secondary|FVC Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
1413669|NCT01152450|Secondary|Trough Forced Vital Capacity (FVC) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FVC is defined as FVC value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
1413670|NCT01152450|Secondary|Trough FEV1 Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 is defined as FEV1 value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
1413671|NCT01152450|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the evening trial-drug inhalation at the end of each 4 week period of randomised treatment.|Baseline and 4 weeks|FAS|||L||Standard Error|Mean
1413672|NCT01152450|Secondary|FEV1 Area Under the Curve 12-24 Hours (AUC12-24h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
1413673|NCT01152450|Secondary|FEV1 Area Under the Curve 0-12 Hours (AUC0-12h) Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4|FAS|||L||Standard Error|Mean
1413674|NCT01152450|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEF p.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS|||L/min||Standard Error|Mean
1413675|NCT01152450|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.|Baseline and during week 4 of each treatment period|FAS|||L/min||Standard Error|Mean
1413676|NCT01152450|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response|Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measurements performed in relation to evening dosing. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.|10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4|Full Analysis Set (FAS) defined as all treated patients who had baseline data and at least 1 on-treatment efficacy measurement after 4 weeks on treatment within a period.|||L||Standard Error|Mean
1413677|NCT01152437|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)|Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.|day 8|Randomised set for wild-type group and treated set for mutated group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1413678|NCT01152437|Secondary|Overall Survival (OS) Time|OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till death, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.|||Days||95% Confidence Interval|Median
1413679|NCT01152437|Secondary|Progression Free Survival (PFS)|PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set for wild-type group and treated set for mutated group.|||Days||95% Confidence Interval|Median
1413680|NCT01152437|Primary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Treated Set. Primary endpoint for the population of patients with KRAS mutated tumours.|||Percentage of Participants||90% Confidence Interval|Number
1413681|NCT01152437|Primary|Percentage of Participants With Objective Response|Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.|Baseline till progression or death, whichever came first, assessed up to 23 months|Randomised set. Primary endpoint for the population of patients with KRAS wildtype tumours.|||Percentage of Participants|||Number
1413694|NCT01152307|Primary|Depression Knowledge|Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).|2 weeks, on average|Participants were randomized to receive the DVD and booklet.|||percent of correct responses||Standard Deviation|Mean
1413695|NCT01152294|Secondary|Value Concordance|Measure of how concordant respondents' actual decisions about treatment for their menopause symptoms are with their stated beliefs|2 weeks, on average|||||||
1413696|NCT01152294|Primary|Menopause Knowledge|Total knowledge score from factual questions about menopause and methods for managing menopause symptoms. Score is the percent of knowledge questions answered correctly (0 - 100%)|2 weeks, on average|Participants were randomized to not receive the decision aid (DVD and booklet)or to receive the decision aid and booklet.|||Percentage (0-100%)||Standard Deviation|Mean
1413697|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck|CPI quantified blood flow in a pre-specified region of interest by using color Doppler imaging. CPI was the mean color pixel intensity in the region of interest and scores could range from 0 to 160. An increase in CPI reflected an increase in blood flow. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1413698|NCT01152190|Secondary|Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4 and Week 8|Randomized participants who received at least 1 dose of study medication.|||ratio||Standard Error|Least Squares Mean
1413699|NCT01152190|Secondary|Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 4|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.|||ratio||Standard Error|Least Squares Mean
1413700|NCT01152190|Primary|Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone|Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity – end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix.|Baseline, Week 8|Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit.|||ratio||Standard Error|Least Squares Mean
1413701|NCT01152112|Secondary|Subject Self-reported Pain Score Occurring During the Treatment Procedure|Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)|1 hour post treatment|||||||
1413702|NCT01152112|Secondary|Percent of Subjects That Achieve 100% Removal of Target Pathology|Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.|Three months post treatment|||||||
1413703|NCT01152112|Primary|Percent Reduction in Target Pathology Volume|Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment|Three months post treatment|A total of 108 pathologies were removed in 74 patients. Among the 108 pathologies removed, 53 were removed in the office setting (28 myomas, 25 polyps) and 55 were removed in the ASC setting (14 myomas, 41 polyps).|||percentage of fibriods/polyps|Fibroids and Polyps|95% Confidence Interval|Mean
1413704|NCT01151904|Secondary|Percentage of Responders With an IOP Reduction ≥20% From Baseline|IOP is a measure of the fluid pressure inside the eye. A responder is defined as a patient with a mean IOP reduction of at least 20% in the affected eye(s) from baseline. Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.||||||
1413705|NCT01151904|Secondary|Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 2, Week 6|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.||||||
1413706|NCT01151904|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 12|Planned analysis population: Intent to Treat: All enrolled patients who received at least 1 dose of study medication, had a valid baseline measurement, and at least one valid post-Day 0 IOP measure. Due to lack of enrollment, analysis was not performed for this outcome measure.||||||
1452338|NCT00835003|Secondary|Duration of Neonatal Treatment With Ventilator, CPAP, Oxygen and/or Antibiotics||30 days|||||||
1413709|NCT01151852|Secondary|Response Rate|"Tumour responses were initially determined by the local investigators in accordance with RECIST 1.0.Treatment decisions were based on local onsite radiological review. All imaging data were subsequently collected, anonymised, and reviewed centrally in a double-blind manner by two external academic radiology reviewers.~Response assessment was determined in a masked central review by use of RECIST1.1."|Up to 12weeks||||percentage of participants|||Number
1413710|NCT01151852|Secondary|Progression Free Survival|To compare PFS assessed by investigators|up to 12 weeks||||Months||95% Confidence Interval|Median
1413711|NCT01151852|Secondary|Disease Control Rate|"Inclusion of complete response, partial response or stable disease~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD."|up to 12 weeks||||percentage of participants|||Number
1413712|NCT01151852|Primary|Progression-free Survival|To compare the progression free survival (PFS) assessed by the blinded independent central review following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with unresectable or metastatic GIST following failure of at least prior imatinib and sunitinib therapies|up tp12 weeks||||Months||95% Confidence Interval|Median
1413713|NCT01151761|Secondary|Median Time to Overall Survival|The time to overall survival is defined as the time to death from any cause. The median was determined via Kaplan Meier methodology.|18 months||||months||95% Confidence Interval|Median
1413714|NCT01151761|Secondary|Liver Transplant Conversion Rate|The ability to successfully perform liver transplant among patients who initially have tumor >3 cm|12 months||||participants|||Number
1413715|NCT01151761|Secondary|Freedom From Local Progression at 12 Months|the proportion of patients who experienced a local recurrence at 12 months with death as a competing risk|12 months|Neither of the two patients that participated in the study had a local recurrence prior to dying.|||percentage of patients|||Number
1413716|NCT01151761|Secondary|Liver Transplant Rate|The number of patients receiving liver transplant among patients who initially have tumors ≤3 cm|12 months||||participants|||Number
1413717|NCT01151761|Secondary|Overall Survival at 12 Months|the estimated probability for the percentage of participants with overall survival at 12 months.|12 months|There were only two patients analyzed. Please take that under advisement when looking at the results.|||probability|||Number
1413718|NCT01151761|Secondary|Serum CA 19-9 Levels|Initial level of Cancer antigen 19-9|12 months||||U/ml||Full Range|Mean
1413719|NCT01151761|Secondary|Pathologic Complete Response Rate|Pathologic complete response will be defined as no residual tumor cells seen on the explanted liver specimen.|12 months||||participants|||Number
1413720|NCT01151761|Primary|Progression-free Survival at 12 Months|Progression free survival is defined to be the time to progression of disease or death.|12 months||||participants|||Number
1413721|NCT01151579|Secondary|Total Number of Participants With Arrhythmias|Documented new arrhythmia occurring during study.|Five days|Number of patients for whom arrhythmias occurred within 5 days after treatment initiation.|||participants|||Number
1413722|NCT01151579|Secondary|Arrhythmias|Any new arrhythmia documented in the medical record that occurred between breathing treatments.|15 minutes after each treatment for average of 3 to 5 days|The percentage of arrhythmias among the number of breathing treatments.|||percent|||Number
1413723|NCT01151579|Primary|Heart Rate in Beats Per Minute|Average difference in Heart rate between pre and post breathing treatments|Five days|Average change in heart rate from baseline to final breathing treatment.|||bpm|Participants|Standard Deviation|Mean
1413724|NCT01151553|Primary|Comparison of Markers of Oxidative Stress Pre and Post Cardiac Resynchronization Therapy as Outcome|Patient has a weak heart and scheduled to have CRT placed in the next month. The study is to evaluate blood markers which may predict which patients who receive CRT will improve|One year|Early termination leading to small numbers of subjects; lost funding and staff, no data collected/processed.||||||
1413725|NCT01151449|Secondary|Overall Survival|Computed using the Kaplan-Meier method.|Within the protocol defined follow-up period.|Inadequate data for OS estimates as only 6 patients were accrued in the study.||||||
1413726|NCT01151449|Secondary|Duration of Radiologic Response|The duration of radiologic response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.||||months|||Number
1413727|NCT01151449|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.|Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 3 months|Inadequate data for PFS estimates as only 6 patients were accrued in the study.||||||
1413728|NCT01151449|Primary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Computed using the Kaplan-Meier method.|Time from start of study treatment to the date of first progression or death from any cause, whichever occurs first, assessed at 6 months|Inadequate data for PFS estimates as only 6 patients were accrued in the study.||||||
1413729|NCT01151449|Primary|Overall Response Rate Using RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.|From start of treatment until disease progression or removal from treatment.||||participants|||Number
1413730|NCT01151436|Secondary|LIP ENHANCEMENT ASSESSMENT|"Lip fullness grading scale score:~0: very thin lip~thin lip~moderately thick lip~thick lip~full lip"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413734|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413735|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413736|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413737|NCT01151436|Secondary|CHEEK FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413738|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413739|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413740|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413741|NCT01151436|Secondary|UPPER LIP LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413742|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413743|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|ININTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413744|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 WEEKS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413745|NCT01151436|Secondary|MARIONETTE LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|BASELINE|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413746|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413747|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 MONTHS AFTER LAST INJECTION|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413748|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413749|NCT01151436|Secondary|PERIORBITAL LINES SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413750|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Error|Mean
1413751|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1452339|NCT00835003|Secondary|Neonatal Diagnoses||30 days|||||||
1413752|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413753|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|6 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale||Standard Deviation|Mean
1413754|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|3 months after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale||Standard Error|Mean
1413755|NCT01151436|Secondary|NASOLABIAL FOLDS SEVERITY ASSESSMENT|"Severity scored on Lemperle Rating Scale:~0: no wrinkles~just perceptible wrinkle~shallow wrinkle~moderately deep wrinkle~deep wrinkle, well-defined edges~very deep wrinkle redundant fold"|baseline|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale|Participants|Standard Deviation|Mean
1413756|NCT01151436|Primary|Full Face Global Aesthetic Improvement|"Global aesthetic improvement scale score from baseline:~-1: worse 0: no change~improved~much improved~very much improved"|3 weeks after last injection|INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)|||units on a scale||Standard Deviation|Mean
1413757|NCT01151410|Secondary|Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP-­DBP).|Baseline to end of study (Week 52 or LOCF)|Full analysis set (FAS) included all randomized patients for this trial|||mmHg||Standard Error|Least Squares Mean
1413758|NCT01151410|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial|||mmHg||Standard Error|Least Squares Mean
1413759|NCT01151410|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline - end of study (Week 52 or Last observation carried forward (LOCF)|Full analysis set (FAS) included all randomized patients for this trial|||millimeter(s) of mercury (mmHg)||Standard Error|Least Squares Mean
1413760|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B|Redness scale of 0 to 4, where 0=None, and 4=Severe.|After 4 Weeks||||units on a scale|eyes|Standard Deviation|Mean
1413761|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.|After 4 Weeks||||units on a scale||Standard Error|Mean
1413762|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B|Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort|After 4 Weeks||||units on a scale||Standard Error|Mean
1413763|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks||||units on a scale||Standard Deviation|Mean
1413764|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B|Scale of 0 to 3, where 0=none and 3=severe staining.|After 4 Weeks||||units on a scale||Standard Deviation|Mean
1413765|NCT01151371|Secondary|Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A|Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.|After 1 Week||||units on a scale||Standard Error|Mean
1413766|NCT01151371|Secondary|Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A|Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort|After 1 Week||||units on a scale||Standard Error|Mean
1413767|NCT01151371|Secondary|Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 Week||||units on a scale||Standard Deviation|Mean
1413768|NCT01151371|Secondary|Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A|Standard scale of 0 to 3 where 0=None, 3=Severe staining|After 1 Week||||units on a scale|eyes|Standard Deviation|Mean
1413769|NCT01151371|Primary|Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 4 Weeks||||units on a scale||Standard Deviation|Mean
1413770|NCT01151371|Primary|Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A|Redness scale of 0 to 4, where 0=None, 4=Severe redness|After 1 Week||||Units on a scale|eyes|Standard Deviation|Mean
1423344|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and 52 week after||||percentage of Neutrophils||Standard Deviation|Mean
1413771|NCT01151371|Primary|Overall Comfort Narafilcon B v. Nelfilcon A|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|After 1 week||||units on a scale||Standard Deviation|Mean
1413772|NCT01151345|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1413773|NCT01151345|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1413774|NCT01151345|Primary|Maximum Observed Plasma Concentration (Cmax)||0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Mean
1413775|NCT01151345|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Mean
1413776|NCT01151345|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose|Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Mean
1413777|NCT01151280|Secondary|Time to Stent Occlusion|"Evidence of stent occlusion~stent occlusion was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data."|mean time from stent placement to stent removal for all 10 patients was 91.3 days.|"All participants were included for analysis.~1/10 subjects experienced stent occlusion at 68 days post stent placement. Mean time to event data was not calculated as only 1 stent occlusion occurred in 10 subjects."|||days|||Number
1413778|NCT01151280|Secondary|Re-intervention Occurrence|Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.|6 months post stent removal|All participants were included for analysis.|||participants|||Number
1413779|NCT01151280|Secondary|Effectiveness of Stent at 6 Months|"Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram.~Effectiveness is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent.~Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms."|From stent removal through 6 months post stent removal follow-up.|Effectiveness was assessed in 9 participants that had stricture resolution at the time of stent removal. 1 participant did not have resolution at removal and therefore could not be assessed in the post stent removal follow-up period.|||participants|||Number
1413780|NCT01151280|Secondary|Technical Success of Stent Placement|Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.|At stent placement (Day 1)|All participants were included for analysis.|||participants|||Number
1413781|NCT01151280|Secondary|Stent Removability|Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.|At 3 months (per protocol removal) or early removal|All participants were included for analysis.|||participants|||Number
1413782|NCT01151280|Secondary|Safety|"Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal.~Unit of measure will be the actual number of adverse events that occurred."|From enrollment through end of study.|All participants were included for analysis.|||adverse events|||Number
1413783|NCT01151280|Primary|Stricture Resolution at the Time of Stent Removal.|Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.|At 3 months (per protocol removal) or at early removal.|All participants were included for analysis.|||participants|||Number
1413784|NCT01151215|Secondary|Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone|Time from the date of randomization to the date of death (by any cause)|Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.|||Months|Participants|Inter-Quartile Range|Median
1423345|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Monocytes|Change from baseline|Baseline and 52 week after||||percentage of Monocytes||Standard Deviation|Mean
1413785|NCT01151215|Primary|Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as >=20% increase in the sum of longest diameters of target lesions and an absolute increase of >=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.|Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012|Full Analysis Set (all participants randomized, irrespective of whether treatment was received). Participants are analysed according to the treatment group they were randomized to.|||Months|Participants|Inter-Quartile Range|Median
1413786|NCT01151189|Secondary|QuantiFERON (QFN) Conversion Rate in MVA85A/AERAS-485 Recipients Compared to Control Subjects Without a Diagnosis of Tuberculosis During the Trial.||For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:~All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0 (QFT negative at baseline subgroup)."|||participants who converted|||Number
1413787|NCT01151189|Secondary|Immunogenicity of MVA85A/AERAS-485 Compared to Placebo as Described by Flow Cytometric Intracellular Cytokine Staining (ICS) of CD4+ and CD8+ T Cells After Stimulation With a Peptide Pool of Mycobacterial Antigens.|The antigen-specific negative control-subtracted response for any cytokine (Interferon gamma [INFγ] , Interleukin 2 [IL2], Interleukin 17 [IL17] and tumor necrosis factor [TNF]).|7 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.|||Percent responding TCells||95% Confidence Interval|Median
1413788|NCT01151189|Secondary|Counts of Spot-forming Units After Stimulation With AG85A Peptide Pool.|Immunogenicity of MVA85A/AERAS-485 compared to placebo as described by the ex vivo interferon (IFN)-γ enzyme linked immunospot (ELISpot).|28 days post second vaccination.|First 70 patients enrolled who also had pre-vaccination results available were analyzed.|||SFU - background/10^6 PBMC||95% Confidence Interval|Median
1413789|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Participants.||Up tp 6 months post second vaccination|"Safety:~All randomized ART + subjects who received a dose of study vaccine, based on actual treatment received."|||copies/mL||Standard Deviation|Geometric Mean
1413790|NCT01151189|Secondary|HIV-1 Viral Load Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART - Participants||Up to 6 months post second vaccination.|"Safety:~All randomized ART - subjects who received a dose of study vaccine, based on actual treatment received."|||copies/mL||Standard Deviation|Geometric Mean
1413791|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in ART+ Subjects||Up to 6 months post second vaccination.|"Safety:~All randomized ART positive subjects who received a dose of study vaccine, based on actual treatment received."|||cells/mm^3||Standard Deviation|Geometric Mean
1413792|NCT01151189|Secondary|CD4+ Lymphocyte Counts Before and After Administration of MVA85A/AERAS-485 Compared to Placebo in Anti-retroviral Therapy Negative (ART -)Subjects||Up to 6 months post second vaccination.|"Safety:~All randomized ART negative subjects who received a dose of study vaccine, based on actual treatment received."|||cells/mm^3||Standard Deviation|Geometric Mean
1413793|NCT01151189|Secondary|Number of TB Cases|Efficacy of MVA85A/AERAS-485 in the prevention of TB disease compared to control subjects who received placebo in HIV-infected, African adult subjects without active TB disease.|For at least 6 months post second vaccination up to 33 months total follow-up.|"Per protocol:~All randomized subjects who received a dose of study vaccine and had no major protocol deviations, were still ongoing in the study 28 days after Study Day 0, and did not have TB diagnosed within 28 days after Study Day 0."|||participants with TB|||Number
1413794|NCT01151189|Primary|Percentage of Participants With Adverse Events|The primary objective of this study is to evaluate the safety of MVA85A/AERAS-485 compared to placebo in HIV-infected, African adult subjects without active TB disease.|Adverse Events (AEs) are recorded for 28 days post vaccination, Serious Adverse Events (SAEs) for at least 6 months post second vaccination.|"Safety:~All randomized subjects who received a dose of study vaccine, based on actual treatment received."|||percentage of participants with an AE|||Number
1413795|NCT01151137|Other Pre-specified|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|Safety population: all randomized and treated participants. Participants were considered according to the treatment actually received. Consequently the participant randomized to the placebo group who received Dronedarone was included in the Dronedarone group.|||participants|||Number
1413796|NCT01151137|Other Pre-specified|Overview of Cardiovascular Events||From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||participants|||Number
1413797|NCT01151137|Secondary|Time to Cardiovascular Death (Cumulative Incidence Function)|"Time to cardiovascular death was defined as the time from randomization to the death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood's variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||proportion of participants||95% Confidence Interval|Number
1413798|NCT01151137|Secondary|Deaths|Deaths were classified according to the primary cause of death.|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||participants|||Number
1413799|NCT01151137|Primary|Time to Second Co-primary Outcome (Cumulative Incidence Function)|"Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood’s variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||proportion of participants||95% Confidence Interval|Number
1413800|NCT01151137|Primary|Time to First Co-primary Outcome (Cumulative Incidence Function)|"Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death.~Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate.~95% confidence interval was computed at each time-point using Greenwood’s variance estimation."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population as previously defined|||proportion of participants||95% Confidence Interval|Number
1413801|NCT01151137|Primary|Overview of the Two Co-primary Outcomes|"First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions [MI], or cardiovascular death.~Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause.~Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks [TIA], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause."|From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)|Intent-to-treat population: All randomized participants considered in the treatment group to which they were randomized regardless of the treatment they actually received|||participants|||Number
1413802|NCT01151098|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety.|Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.|28 weeks|The Extension Safety population (N = 189) includes all subjects who were exposed to BTDS during the Open-label Extension Phase and provided at least 1 valid safety assessment after exposure to BTDS during the Open-label Extension Phase.|||participants|||Number
1413803|NCT01151085|Secondary|Number of Participants That Responded to Voriconazole Treatment -Severity of Infections.|Number of participants that responded to voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1413804|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Past History.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether with or without Past History is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1413805|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Severity of Infections.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether severity of infections(mild, moderate or severe) is significant risk factor.|16 weeks||||participants|||Number
1413806|NCT01151085|Secondary|Risk Factors for the Frequency of Treatment Related Adverse Events -Gender.|Number of participants with Treatment Related Adverse Events of Voriconazole to determine whether male or female is significant risk factor.|16 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1413807|NCT01151085|Secondary|Number of Unlisted Treatment Related Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Voriconazole. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|16 weeks|No statistical analysis provided for the number of the unlisted treatment related adverse events in Japanese Package Insert.|||events|||Number
1413808|NCT01151085|Primary|Number of Participants That Responded to Voriconazole Treatment.|The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the subjects for efficacy analysis.|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1413809|NCT01151085|Primary|Number of Participants With the Frequency of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|No statistical analysis provided for the frequency of treatment related adverse events.|||participants|||Number
1413810|NCT01151046|Secondary|Overall Survival|To determine whether MM-121 + exemestane is more effective than placebo + exemestane in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, over approximately 2 years||||weeks||95% Confidence Interval|Median
1413811|NCT01151046|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Exemestane in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RT-PCR for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to exemestane can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 79.1 weeks|Patients with available tissue for RT-PCR analysis|||months PFS||95% Confidence Interval|Median
1413821|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 366 up to Day 457 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.|||Percentage of participants|||Number
1413812|NCT01151046|Primary|Progression Free Survival (PFS)|"To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 79.1 weeks||||weeks||95% Confidence Interval|Median
1413813|NCT01151020|Primary|Patients With Device Failures|Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.|12 months||||participants|||Number
1413814|NCT01151020|Primary|Patients With Major Adverse Events (MAE)|"Major adverse event is defined as:~All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room."|30 days|1 patient had a stroke and required ventilation >72 hours/reintubation.|||participants|||Number
1413815|NCT01150981|Secondary|Serum Adiponectin|Adiponectin concentrations in serum were measured in ng/ml, in both arms at baseline and at 8 weeks, i.e. 2 weeks after stopping drug or placebo treatment|8 weeks||||ng/ml||Standard Error|Mean
1413816|NCT01150981|Primary|Adipose Tissue Capillary Sprout Formation|Adipose tissue collected at 8 weeks was cut into ~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14.|8 weeks|The number of subjects was based on the power of calculations in being able to demonstrate a difference from baseline in fat tissue microvasculature, change in HOMA2 and serum adiponectin after 6 weeks of rosiglitazone intake in all groups.|||number of capillary sprouts||Standard Deviation|Mean
1413817|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period|New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
1413818|NCT01150903|Secondary|Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 2 years (End of study period - July 2006 to June 2008)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
1413819|NCT01150903|Secondary|Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period|New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
1413820|NCT01150903|Primary|Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period|Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Up to 3 years (Early study period - January 1999 to December 2001)|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants|||Number
1423346|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Lymphocytes|Change from baseline|Baseline and 52 week after||||percentage of Lymphocytes||Standard Deviation|Mean
1413822|NCT01150903|Primary|Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription|New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.|||Percentage of participants|||Number
1413823|NCT01150903|Primary|Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91|New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day 0 to Day 91 post index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.|||Percentage of participants|||Number
1413824|NCT01150903|Primary|Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription|Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.|Day -92 up to Day -1 of index prescription|Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.|||Percentage of participants|||Number
1413825|NCT01150760|Primary|Intensive Care Unit Length of Stay||Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Days||Standard Deviation|Mean
1413826|NCT01150760|Primary|Percentage of Patients Discharged to Various Locations|Location of discharge for patients who were admitted to the hospital for their bowel resection from home|Hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of participants|||Number
1413827|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 30 Days of Discharge||Between 0-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of participants|||Number
1413828|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Between 16 and 30 Days After Discharge||Between 16-30 days after hospital discharge after bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of participants|||Number
1413829|NCT01150760|Primary|Percentage of Patients Who Were Readmitted Within 15 Days of Discharge||Within 15 days of discharge from hospitalization for bowel resection|Intent-to-treat population (included patients who met all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during the patient's hospitalization)|||Percent of partcipants|||Number
1413830|NCT01150760|Primary|Percentage of Patients With In-hospital Other Morbidity|Other morbidity was identified using ICD-9-CM diagnosis and procedure codes for disruption of wound, decubitus ulcer, or postoperative complications not elsewhere classified.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413831|NCT01150760|Primary|Percentage of Patients With In-hospital Thromboembolic Morbidity|Thromboembolic morbidity was identified using ICD-9-CM diagnosis and procedure codes for pulmonary embolism and infarction; arterial embolism and thrombosis or thrombosis of the lower extremities; vascular disorders of the kidney; acute vascular insufficiency of the intestine; or venous thromboembolism.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413832|NCT01150760|Primary|Percentage of Patients With In-hospital Infection Morbidity|Infection morbidity was identified using ICD-9-CM diagnosis and procedure codes for infection due to central venous catheter; abscess of intestine; peritoneal abscess; sepsis or severe sepsis; infection due to vascular device, implant and graft; urinary tract infection; disruption of internal or external surgical wound; persistent postoperative fistula; or postoperative infection.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413833|NCT01150760|Secondary|Postoperative Length of Hospital Stay|Calendar day of discharge - calendar day of surgery = postoperative length of stay|Measured from the day after bowel resection to the day of hospital discharge|Modified intent-to-treat (included patients who met all base population, inclusion and exclusion criteria, received ≥ 3 and ≤ 15 doses of alvimopan [for alvimopan cohort] during the patient's hospitalization, and received parenteral opioid on ≥ 1 postoperative day)|||Days||Standard Deviation|Mean
1413852|NCT01150474|Secondary|Pain at Hour 20|"Pain at 20 hours was recorded using a linear analog pain scale, with 0 being no pain, and 10 being worst pain imaginable."|20 hours after surgery.||||units on a scale||Standard Deviation|Mean
1452340|NCT00835003|Primary|Neonatal Admission After Elective Caesarean Section||48 hours||||participants|||Number
1413834|NCT01150760|Primary|Percentage of Patients With In-hospital Pulmonary Morbidity|Pulmonary morbidity was identified using ICD-9-CM diagnosis and procedure codes for pneumonia; infectious pneumonia; respiratory complications, pulmonary collapse; acute respiratory failure or edema; pulmonary congestion and hypostasis; pulmonary/respiratory insufficiency after trauma and/or surgery; dyspnea; or respiratory arrest; transfusion related acute lung injury.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413835|NCT01150760|Primary|Percentage of Patients With In-hospital Cerebrovascular Morbidity|Cerebrovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for ischemic, thrombotic, embolic or hemorrhagic cerebrovascular accidents; acute but ill-defined cerebrovascular disease; transient cerebral ischemia; syncope; or postoperative cerebrovascular accident.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413836|NCT01150760|Primary|Percentage of Patients With In-hospital Cardiovascular Morbidity|Cardiovascular morbidity was identified using ICD-9-CM diagnosis and procedure codes for myocardial infarction; other ischemic events; congestive heart failure and shock; arrhythmias; or other cardiovascular events (cardiac complications, peripheral vascular complications).|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413837|NCT01150760|Primary|Percentage of Patients With Reported In-hospital Postoperative Gastrointestinal (GI) Morbidity|GI morbidity will be identified using International Classification of Disease 9th Edition Clinical Modification (ICD-9-CM) diagnosis and procedure codes for paralytic ileus, flatulence, eructation, gas pain, insertion of a nasogastric tube, total parenteral nutrition, peripheral parenteral nutrition, digestive symptom complications, diarrhea following GI surgery, intestinal obstruction, abdominal pain, peritoneal adhesions, unspecified protein-calorie malnutrition, parenteral infusion of concentrated nutritional substances, or enteral infusion of concentrated nutritional substances.|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413838|NCT01150760|Primary|Percentage of Patients Who Died|All-cause|Participants were followed up until their hospital discharge after bowel resection|Intent-to-treat population (Included patients who meet all base population, inclusion and exclusion criteria, and had at least 1 administration of alvimopan [for the alvimopan cohort] during their hospitalization)|||Percent of participants|||Number
1413839|NCT01150500|Secondary|Clinical Endpoints|Success (device, lesion, procedure), major adverse cardiac events (MACE), target vessel failure (TVF), and stent thrombosis|5 Years|||||||
1413840|NCT01150500|Secondary|Percent Diameter Stenosis|The value calculated as 100 x (Reference Vessel Diameter(RVD) - Minimum luminal diameter(MLD))/ RVD using the mean values from orthogonal views (when possible) by quantitative coronary angiography(QCA).|Baseline and 9 month|67 lesions in 65 patients were analyzed.|||% DS (diameter stenosis)||Standard Deviation|Mean
1413841|NCT01150500|Secondary|Minimum Luminal Diameter|The average of two orthogonal views(when possible) of narrowest point within the area of assessment-in lesion, in stent or in segment. minimal luminal diameter is visually estimated during angiography by the investigator; it is measured during quantitative coronary angiography by the Angiographic Core Laboratory.|9 month|67 lesions in 65 patient were analyzed.|||mm||Standard Deviation|Mean
1413842|NCT01150500|Secondary|Binary Angiographic Restenosis|Defined as => 50% in-stent diameter stenosis at the follow-up angiogram at 9 month. If an in-stent measurement is not available, the in-lesion diameter was used.|Baseline and 9 month|67 lesions in 65 patients were analysed.|||percentage of patient|||Number
1413843|NCT01150500|Secondary|Late Lumen Loss|Defined as the difference between the post-procedure immediate minimal lumen diameter (MLD) and the follow-up angiography MLD at 9 month.|Baseline and 9 months|67 Lesions in 65 patients are analysed.|||mm||Standard Deviation|Mean
1413844|NCT01150500|Secondary|MACE (Major Adverse Cardiac Event)|Death, myocardial infarction (Q-wave and non-Q-wave), emergent coronary bypass, or clinically-driven repeat target lesion revascularization by percutaneous surgical methods.|Baseline and 9 month|65 patients were analyzed as ITT population|||percentage of patient|||Number
1413845|NCT01150500|Primary|Target Lesion Failure(TLF)|Target Lesion Failure (TLF) at 9 months post-procedure defined as a composite measure of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven target lesion revascularization (TLR)|9 month|All 65 patients enrolled were analyzed as intent-to-treat (ITT) population and per protocol(PP) population.|||percentage of TLF|||Number
1413846|NCT01150474|Secondary|Satisfaction With Pain Relief|"Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being very dissatisfied, and 10 being very satisfied."|Approximately 24 hours following surgery||||units on a scale||Standard Deviation|Mean
1413847|NCT01150474|Secondary|Number of Subjects Who Used Antiemetic Rescue Medications||First 24 hours after surgery||||participants|||Number
1413848|NCT01150474|Secondary|Number of Times Antiemetic Rescue Medication Was Used||First 24 hours after surgery||||number of times antiemetics used||Standard Deviation|Mean
1413849|NCT01150474|Secondary|Number of Subjects With Vomiting|This information was taken from the medical record.|Within 20 hours of surgery||||participants|||Number
1413850|NCT01150474|Secondary|Number of Subjects With Nausea|This information was taken from the medical record.|Approximately 12 hours after surgery||||participants|||Number
1413851|NCT01150474|Secondary|Narcotic Rescue Medication|Use of all ancillary narcotic medications was taken from the medical record.|For 24 hours following surgery||||mg IV morphine equivalents||Standard Deviation|Mean
1455515|NCT00811317|Secondary|Glucagon T-max|Time to maximum peak glucagon concentration|24 hours||||minutes||Standard Deviation|Mean
1413858|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non-­Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non­dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."|||mmHg||Standard Deviation|Mean
1413859|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm – 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am –6pm) ABPM.|Baseline to endpoint (Week 4 or LOCF)|"Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."|||mmHg||Standard Deviation|Mean
1413860|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)|ABPM was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.|Baseline to Week 4|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mmHg||Standard Error|Least Squares Mean
1413861|NCT01150357|Secondary|Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)|Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24­hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24­hour monitoring period for removal of device and BP assessments. The ABPM device was pre­set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 – 24 hours.|Baseline to endpoint (Week 4 or LOCF)|Analysis was performed in subset of FAS participants from selected centers who consented to undergo ABPM at baseline and at Week 4 or LOCF. Here 'Number of participants analyzed' signifies those participants evaluable for this measure at specified time points for each arm, respectively.|||mmHg||Standard Deviation|Mean
1413862|NCT01150357|Secondary|Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)|Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for this outcome measure at Week 4 or LOCF for each arm, respectively."|||Percentage of participants|||Number
1413863|NCT01150357|Secondary|Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3*(SBP-DBP).|Week 4 to endpoint (Week 8 or LOCF)|The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mmHg||Standard Error|Mean
1413864|NCT01150357|Secondary|Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)|MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP­DBP).|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for MAP at Week 4 (or LOCF) for each arm, respectively."|||mmHg||Standard Error|Mean
1413865|NCT01150357|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 8 or LOCF for each arm, respectively."|||mmHg||Standard Error|Mean
1413866|NCT01150357|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or LOCF)|"The analysis was performed on the FAS population. Here, Number of participants analyzed signifies participants evaluable for msDBP at Week 4 or LOCF for each arm, respectively."|||mmHg||Standard Error|Mean
1413867|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|From Week 4 to Week 8|The analysis was performed on the SAF which included all participants who received at least one dose of study treatment during phase 2 (week 4 to week 8).|||participants|||Number
1416684|NCT01124643|Secondary|Change From Baseline in eGFR||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||(mL/min/1.73m^2)||Standard Deviation|Mean
1413868|NCT01150357|Secondary|Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)|Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|Baseline up to Week 4|The analysis was performed on the Safety Sets (SAF), SAF is all participants who received at least one dose of study treatment during phase 1 (baseline to week 4)|||participants|||Number
1413869|NCT01150357|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Week 4 to endpoint (Week 8 or LOCF)|The primary analysis was performed on the FAS population.|||mmHg||Standard Error|Mean
1413870|NCT01150357|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1­2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))|"The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post­baseline assessment for primary efficacy. Here, Number of participants analyzed signifies participants evaluable for msSBP at Week 4 or LOCF for each arm, respectively."|||millimeter(s) of mercury (mmHg)||Standard Error|Mean
1413871|NCT01150123|Secondary|Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2|GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.|Day 1 and Day 721|Analysis was done on secondary persistence PPS.|||Ratios||95% Confidence Interval|Geometric Mean
1413872|NCT01150123|Secondary|Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1|GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.|Day 1 and Day 721|Analysis was done on secondary persistence PPS|||Ratios||95% Confidence Interval|Geometric Mean
1413873|NCT01150123|Secondary|Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2|The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.|Day 1 and Day 721|Analysis was done on secondary persistence PPS.|||µg/mL||95% Confidence Interval|Geometric Mean
1413874|NCT01150123|Secondary|Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1|The persistence of Serotype–specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.|Day 1 and Day 721|Analysis was done on secondary persistence PPS - All the subjects who provided all serum sample results from Baseline (prior to vaccination) through Day 721 within protocol required windows.|||µg/mL||95% Confidence Interval|Geometric Mean
1413875|NCT01150123|Secondary|Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2|Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.|Day 1 through Day 721|Analysis was done on Unsolicited Safety Set.|||participants|||Number
1413876|NCT01150123|Secondary|Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1|Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.|Day 1 through Day 721|Analysis was done on unsolicited safety set - All subjects in the Exposed Set who provided information about postvaccination unsolicited AEs.|||participants|||Number
1413877|NCT01150123|Secondary|Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2|Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.|Day 1 to Day 7|Analysis was done on Solicited Safety Set|||participants|||Number
1413878|NCT01150123|Primary|Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361|GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.|Day 1 and day 361|Analysis was done on Co-Primary PPS.|||Ratios||95% Confidence Interval|Geometric Mean
1413879|NCT01150123|Primary|Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361|Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.|Day 1 and Day 361|Analysis was done on Co-Primary PPS|||µg/mL||95% Confidence Interval|Geometric Mean
1413880|NCT01150123|Primary|Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2|The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.|Day 1 and Day 361|Analysis was done on Co-primary PPS - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 361; and had no major protocol violations as defined prior to analysis|||percentage of subjects|||Number
1413881|NCT01150123|Primary|Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype|Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.|Day 61/Day 1|Analysis was done on Primary PPS.|||Ratios||95% Confidence Interval|Geometric Mean
1413882|NCT01150123|Secondary|Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1|Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.|Day 1 to Day 7|Analysis was done on Solicited Safety Set - All subjects in the Exposed Set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.|||participants|||Number
1413883|NCT01150123|Primary|Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61|Serotype–specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.|Day 1 and Day 61|Analysis was done on Primary PPS|||µg/mL||95% Confidence Interval|Geometric Mean
1413884|NCT01150123|Primary|Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1|The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.|Day 1 and Day 61|Analysis was done on primary Per Protocol Set (PPS) - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 61; and had no major protocol violations as defined prior to analysis.|||percentage of subjects|||Number
1413885|NCT01150097|Primary|Change in Renal Function|Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m^2) = 186.3*(C^-1.154)*(A^-0.203)*G*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.|from months 24 to 36|The analysis population included extension participants who had both post-extension baseline and month 36 values only.|||mL/min/1.73m^2||Standard Deviation|Mean
1413886|NCT01150097|Secondary|Incidence Rate of tBPAR|The number of participants who had a tBPAR was analyzed. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection.|from months 24 - 36|All extension participants|||Participants|||Number
1413887|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 - 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group|||Participants|||Number
1413888|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death|The number of participants who experienced graft loss or death was analyzed. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants|||Participants|||Number
1413889|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 36 to 48|Participants from the everolimus + reduced tacrolimus group and the tacrolimus elimination group|||Participants|||Number
1413890|NCT01150097|Primary|Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death|The number of participants who experienced composite efficacy failure was analyzed. Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, and venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, received a graft re-transplant, or died.|from months 24 to 36|All extension participants|||Participants|||Number
1413891|NCT01149876|Secondary|Change in Rhytides|"Secondary outcome measures will be change in rhytides of baseline compared to week 16.~Rhytides will be assessed clinically using a 0-6 scale where 0 is no lines and 6 is very deep lines."|baseline to week 16||||units on a scale||Standard Deviation|Mean
1413892|NCT01149876|Primary|Change in Hyperpigmentation of the Face|"Primary outcome measure will be change in hyperpigmentation of baseline compared to week 16.~Hyperpigmentation will be measured clinically using a 0-6 scale where 0 is no hyperpigmentation and 6 is very severe hyperpigmentation."|baseline to 16 weeks||||units on a scale||Standard Deviation|Mean
1413893|NCT01149863|Secondary|Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs||Within the first 5 days following plerixafor initiation||||Participants|||Number
1413894|NCT01149863|Primary|Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.||Within the first 5 days following plerixafor initiation||||Participants|||Number
1416685|NCT01124643|Secondary|Change From Baseline in Plasma Gb3||Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||(nmol/mL)||Standard Deviation|Mean
1413895|NCT01149785|Secondary|Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (Cmax).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1413896|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC(0-∞)]|Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞) [MRAUC(0-∞)].|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1413897|NCT01149785|Secondary|Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1413898|NCT01149785|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1413899|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1413900|NCT01149785|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413901|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413902|NCT01149785|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
1413903|NCT01149785|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1413904|NCT01149785|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1413905|NCT01149785|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1416753|NCT01124305|Secondary|Number of Instrument Trays Required||1 day|per protocol|||number of trays||Standard Deviation|Mean
1413906|NCT01149785|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1413907|NCT01149785|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413908|NCT01149785|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (Pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1413909|NCT01149772|Primary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ measures the health status of patients with congestive heart failure. The overall score is a mean score scaled from 0 - 100; where 0 represents most severe/limited functioning.|4 month (post treatment), 8 month follow/up, and 12 month follow/up|Only patients randomized for heart failure was required to complete the assessment. There were fewer patients randomized for congestive heart failure (CHF) as compared to COPD.|||units on a scale||Standard Deviation|Mean
1413910|NCT01149772|Primary|Chronic Respiratory Questionnaire_Dyspnea|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Dyspnea looks at how much shortness of breath a patient experiences. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (Chronic Obstructive Pulmonary Disease, emphysema, bronchitis, asthma) completed this assessment.|||units on a scale||Standard Deviation|Mean
1413911|NCT01149772|Primary|Chronic Respiratory Questionnaire_Mastery|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. The subscale Mastery looks at the patient's perceived control over the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.|||units on a scale||Standard Deviation|Mean
1413912|NCT01149772|Primary|Chronic Respiratory Questionnaire_Fatigue|The Chronic Respiratory Questionnaire (CRQ) measures the quality of life of patients with a chronic respiratory disease. This subscale measures the amount of fatigue patients experience with the condition. The CRQ is a mean score and ranges from 1 - 7, where a higher score = better health.|4 month (post treatment), 8 month follow/up, 12 month follow/up|Only patients experiencing chronic lung problems (COPD, emphysema, bronchitis, asthma) completed this assessment.|||units on a scale||Standard Deviation|Mean
1413913|NCT01149772|Primary|Beck Anxiety Inventory (BAI)|The BAI measures an individual's level of anxiety. The measure is summed and ranges from 0 - 63 (individual item score range 0 -3 per 21 items); were higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up||||units on a scale||Standard Deviation|Mean
1413914|NCT01149772|Primary|Patient Health Questionnaire -9 (PHQ-9)|The PHQ-9 measures an individual's level of depression. The measure is summed and ranges from 0 - 27 (individual item score range 0 - 3 per 9 items); where higher scores = worse symptoms.|4 month (post treatment), 8 month follow/up, and 12 month follow/up||||units on a scale||Standard Deviation|Mean
1413915|NCT01149759|Secondary|Change in Epidermal Thickness|Change in lesional skin epidermal thickness at week 12 compared to baseline|12 weeks|9 participants were included in this analysis from Rockefeller University, this is a change in the skin thickness at week 12 compared to baseline|||micrometer||Standard Deviation|Mean
1413916|NCT01149759|Primary|SCORAD Change Score|"SCORAD (SCORing Atopic Dermatitis) is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis (AD) as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe AD. For this outcome the SCORAD change score is computed as an absolute number which is comparing improvement in the SCORAD score of participants at week 12 compared to their SCORAD score at baseline."|12 weeks|9 were included in this analysis from Rockefeller University|||Change Score||Standard Deviation|Mean
1413917|NCT01149733|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf|Blood samples drawn over 60 hour period||||ng*h/mL||Standard Deviation|Mean
1413918|NCT01149733|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t|Blood samples drawn over 60 hour period||||ng*h/mL||Standard Deviation|Mean
1413919|NCT01149733|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax|Blood samples drawn over 60 hour period||||ng/mL||Standard Deviation|Mean
1413929|NCT01149655|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of all participants who were randomized to period 3.|||percentage of participants|||Number
1413920|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).|The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 95 and 45.|||Units on a scale||Standard Deviation|Mean
1413921|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Negative Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.|||Units on a scale||Standard Deviation|Mean
1413922|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Positive Subscale.|The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45.|||Units on a scale||Standard Deviation|Mean
1413923|NCT01149655|Other Pre-specified|Mean CGI-I Score at Endpoint.|Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. Response choices included: 0 = not assessed; 1 = very much improved,;2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.|||Units on a scale||Standard Deviation|Mean
1413924|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in CGI-S Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0= not assessed; 1= normal, not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF method was used to impute missing data. Week 1 participants analyzed were 94 and 45 and Week 2 to Week 52 participants analyzed were 97 and 48.|||Units on a scale||Standard Deviation|Mean
1413925|NCT01149655|Other Pre-specified|Mean Change From Baseline to Endpoint in PANSS Total Score.|The PANSS consisted of 3 subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants randomized to period 3. LOCF (last observation carried forward) method was used to impute missing data. Week 1 had only 95 and 45 participants analyzed.|||Units on a scale||Standard Deviation|Mean
1413926|NCT01149655|Secondary|Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.|Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants who were randomized to period 3.|||percentage of participants|||Number
1413927|NCT01149655|Secondary|Percentage of Participants Who Had Achieved Remission.|Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.|Baseline to Week 52/End of Phase 3 visit.|The ITT data set comprised of participants who were randomized to the double-blind treatment. For evaluation of remission, 48 of 98 aripiprazole participants and 19 of 48 placebo participants met the 6 month threshold for remission analysis. Of those, 21 of 48 aripiprazole participants and 8 of 19 placebo participants met criteria for remission.|||percentage of participants|||Number
1413928|NCT01149655|Secondary|Percentage of Responders in Each Treatment Group.|Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.|Baseline to Week 52/End of Phase 3 visit|The ITT data set comprised of all participants were randomized to period 3.|||percentage of participants|||Number
1413943|NCT01149486|Secondary|Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1414373|NCT01146054|Secondary|Evaluate Acute Gastrointestinal Toxicity up to 3 Months of Treatment.|Acute grade 2 or greater gastritis, fistula, enteritis, or ulcer or any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.|Within 3 months of treatment.|Whole cohort.|||Number of toxicities.|||Number
1413930|NCT01149655|Primary|Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.|The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of “yes” to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.|Baseline to Week 52/End of Phase 3 visit.|For the primary analysis, participants that belonged to the ITT (intent to treat) data set were included in the analysis. Participants who were lost to follow-up or who were still in the study at the end of Week 52 were considered as censored on their date of last efficacy evaluation. The ITT data set comprised participants randomized to period 3.|||relapse rate(percentage of participants)|||Number
1413931|NCT01149616|Secondary|Postop Nausea|NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.|24 hours||||units on a scale||Inter-Quartile Range|Mean
1413932|NCT01149616|Secondary|Amount of Postop Narcotic Usage|Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge|24 hours||||number of tablets||Inter-Quartile Range|Median
1413933|NCT01149616|Primary|Post Operative VAS Pain Scale|Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.|24 hours||||units on a scale||Standard Deviation|Mean
1413934|NCT01149538|Secondary|Evoked Response Potential - Negative Component Latency|Evoked Response Potential - negative component latency data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable data (choline and placebo arms)|||Milliseconds||Standard Deviation|Mean
1413935|NCT01149538|Secondary|Evoked Response Potentials Microvolts|Evoked response potentials were measured for the memory task. Frontal positive slow-wave potential negative component amplitude data are included.|Baseline, 6 months, and 9 months|Children with FASD who were administered Evoked Response Potential test and provided usable date (choline and placebo arms)|||Mircovolts||Standard Deviation|Mean
1413936|NCT01149538|Secondary|Elicited Imitation Task Memory|The Elicited Imitation (EI) paradigm (P.J. Bauer, 1989, Dev. Psychology) was used to measure memory in the participants at baseline, 6 months, and 9 months. The measures were items recalled after a delay (delayed items) and pairs of items recalled after a delay (delayed pairs). The sample was split by age in the analysis (young vs. old) as reflected in the outcome data. Outcome data measures included here are the slopes of the regression lines reflecting change over the three timepoints, controlling for immediate memory performance on the EI task.The slopes are given, as opposed to the raw scores, because these were the values used in the growth curve analyses. Details of these analyses are included in Wozniak et al. (2015) AJCN, doi:10.3945/ajcn.114.099168. NOTE that the means presented below represent the simple slopes that estimate the change in task performance (% of items correct) per 6-month unit of time. To estimate change in task performance over 9 months, multiply by 1.5.|Baseline, 6 months, and 9 months|Young choline group (n=17); Young placebo group (n=13); Old choline group (n=14); Old placebo group (n=16).|||Slope||Standard Error|Mean
1413937|NCT01149538|Primary|Mullen Scales of Early Learning - Early Learning Composite|The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details.|Baseline and 9 months|Including those with partial completion (drop-outs and lost-to-followup).|||units on a scale||Standard Deviation|Mean
1413938|NCT01149538|Primary|Side Effects of Choline Bitartrate|Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.|Baseline, 6 months, & 9 months|Children with fetal alcohol spectrum disorders receiving either choline or placebo for 9 months|||participants|||Number
1413939|NCT01149512|Secondary|% of Excess Body Weight Loss|the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years|baseline to 1 year, baseline to 2 years, baseline to 3 years|3 not included the same reason as above.|||% of excessive weight loss||Standard Deviation|Mean
1413940|NCT01149512|Primary|Mean Percentage Total Body Weight Loss|the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years|baseline to 1 year, baseline to 2 years, baseline to 3 years|Three patients’ weight data were not included in the weight loss analysis owing to early removal of band (n = 1) and complication or pregnancy affecting weight (n = 2) before 1-year follow-up. 79 patients reached 2 year follow up time point and 38 patients reached 3 year follow up time point.|||% of total body weight loss||Standard Deviation|Mean
1413941|NCT01149486|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413942|NCT01149486|Secondary|AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1414382|NCT01145898|Primary|6-month Change in Ocular Perfusion Pressures (OPP)|Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.|Baseline and 6 month visits||||mm Hg||Standard Error|Mean
1413944|NCT01149486|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413945|NCT01149486|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413946|NCT01149486|Primary|Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1413947|NCT01149486|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413948|NCT01149486|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413949|NCT01149486|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1413950|NCT01149473|Primary|AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Hydrochlorothiazide AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413951|NCT01149473|Primary|AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Hydrochlorothiazide AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413952|NCT01149473|Primary|Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Hydrochlorothiazide Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1413953|NCT01149473|Primary|AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413954|NCT01149473|Primary|AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1413955|NCT01149473|Primary|Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1413956|NCT01149460|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1413957|NCT01149460|Secondary|AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1413958|NCT01149460|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir||Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1413959|NCT01149460|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1413960|NCT01149460|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1413961|NCT01149460|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1413962|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years||||Participants|||Number
1413963|NCT01149434|Primary|Tumor Response in the Ovarian Cancer Cohort|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors|2 years|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. The number of patients enrolled on the remaining cohorts were not included in this analysis.|||Participants|||Number
1413964|NCT01149434|Primary|Progression Free-Survival in the Ovarian Cancer Cohort|progression-free survival at 2 months. We define progression as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), to detect a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 months|The intent of this trial was to analyze three different cohorts of patients with different diagnosis. This analysis was conducted with 8 of the enrolled patients that had ovarian disease. Patients enrolled on the remaining cohorts were excluded in this analysis. Results were calculated using Kaplan-Meier product limit methods.|||percentage of participants||95% Confidence Interval|Number
1455516|NCT00811317|Secondary|Total Insulin Dose||24 hours||||u/kg||Standard Deviation|Mean
1413965|NCT01149434|Secondary|Tumor Response|Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years||||participants|||Number
1413966|NCT01149434|Secondary|Safety and Tolerability of JI-101|Number of patients experiencing a grade 2 or higher Adverse Event related to JI101|2 years||||participants|||Number
1413967|NCT01149434|Primary|Effect of RAD001 on Pharmacokinetics AUC(0-inf) of JI-101|Determine the mean percent change that RAD001 has on the peak concentration as determined by calculating the AUC (0-inf) of JI101 in the presence and absence of RAD001|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 8 for RAD001 + JI101 and Cycle 1 Day 15 for JI-101 alone||||percentage change||Full Range|Mean
1413968|NCT01149434|Primary|Effect of JI 101 on Pharmacokinetics Area Under Curve (AUC) (0-inf) of RAD001|Determine the mean percent change that JI-101 has on the peak concentration as determined by calculating the AUC (0-inf) of RAD001 in the presence and absence of JI-101|pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 1 for RAD001 alone and Cycle 1 Day 8 for RAD001 + JI-101||||percentage change||Full Range|Mean
1413969|NCT01149421|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve [AUC] at steady state from time zero to 168 hours after study drug administration). Evaluable pharmacokinetic concentrations from the 4, 8, 12, 16, and 26 weeks timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4, 8, 12, 16, and 26 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.|||nanograms*hour per liter (ng*h/L)||Standard Deviation|Mean
1413970|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Body Weight|Least Squares (LS) means was calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable body weight data.|||kilogram (kg)||Standard Error|Least Squares Mean
1413971|NCT01149421|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic events (HE) were classified as severe (defined as an HE requiring assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as an HE without typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), nocturnal (defined as any HE occurring between bedtime and waking with a measured blood glucose of ≤3.9 mmol/L), or non-nocturnal. Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Logit link. Negative binomial mean was adjusted by treatment, visit, and visit by treatment interaction. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||events per participant per 30 days||Standard Deviation|Mean
1413972|NCT01149421|Secondary|Anti-LY2189265 Antibodies|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 16 and 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (30 weeks). The number of participants with initial postbaseline detection of treatment-emergent (defined as a 4-fold increase in the ADA titer from baseline) anti-drug (LY2189265) ADA at each time point were summarized.|Baseline, 16, 26, and 30 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable anti-drug (LY2189265) antibodies (ADA) data.|||participants|||Number
1413973|NCT01149421|Secondary|Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||participants|||Number
1413974|NCT01149421|Secondary|Number of Events of Adjudicated Pancreatitis up to 26 Weeks|The number of adjudicated (by an independent Clinical Endpoint Committee [CEC]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||events|||Number
1413975|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable Fridericia-corrected QT (QTcF) or PR interval change from baseline data.|||milliseconds (msec)||Standard Error|Least Squares Mean
1413976|NCT01149421|Secondary|Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)||Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable High-Sensitivity C-Reactive Protein (hs-CRP) data.|||milligram per liter (mg/L)||Standard Deviation|Mean
1413977|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Serum Calcitonin||Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable serum calcitonin data.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1413978|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pancreatic enzyme data.|||units per liter||Inter-Quartile Range|Median
1413979|NCT01149421|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who received at least one dose of LY2189265 or Placebo.|||participants|||Number
1413980|NCT01149421|Secondary|Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7% or ≤6.5% were analyzed with Chi-squared test/Fisher’s exact test.|Baseline and 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.|||percentage of participants|||Number
1413981|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)|Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable fasting blood glucose data.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1413982|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)|Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable glycosylated hemoglobin (HbA1c) data.|||percentage of HbA1c||Standard Error|Least Squares Mean
1413983|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)|Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1413984|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure|Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1413985|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)|Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1413986|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)|Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1414051|NCT01148771|Primary|Area Under the Curve From 48 to 72 Hours [AUC(48-72)]|AUC(48-72) is the 24 hour area under the concentration versus time curve after the 3rd dose of ertapenem, which is selected to measure approximate AUC at steady-state.|0-24 hours after 3rd ertapenem dose||||mcg*hr/mL||Standard Deviation|Mean
1423347|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Basophils|Change from baseline|Baseline and 52 week after||||percentage of Basophils||Standard Deviation|Mean
1413987|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)|Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1413988|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)|Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable mean arterial pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1413989|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure|Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable pulse pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1413990|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)|Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1413991|NCT01149421|Secondary|Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)|Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 and 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable diastolic blood pressure data.|||millimeters of mercury (mmHg)]||Standard Error|Least Squares Mean
1413992|NCT01149421|Secondary|Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable systolic blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1413993|NCT01149421|Primary|Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant’s nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.|Baseline, 16 weeks|Participants who received at least one dose of LY2189265 or Placebo with evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1414088|NCT01148056|Primary|Bowel Quality of Life|To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.|2 years|Study was terminated early due to slow accrual. Analysis was not performed.||||||
1413994|NCT01149343|Secondary|Duration of Response for Patients With CR, PR and SD or SD/PR Status (Phase II)|This analysis was not performed following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG/anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.|Up to concluding visit, at Week 199|This analysis was not performed.||||||
1413995|NCT01149343|Secondary|Time to Treatment Failure, Progression Free Survival and Overall Survival (Phase I & II)|Time to treatment failure (TTF) was defined as the time from first administration of study product until the date of the last administration of the product, irrespective of the reason for study treatment discontinuation. Progression-free survival (PFS) was defined as the time from first adminsitration of study product until the date of either disease progression or death (for whatever reason), whichever comes first. Overall survival (OS) was defined as the time from first administration of study product until death.|Up to concluding visit, at Week 199|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Months||95% Confidence Interval|Median
1413996|NCT01149343|Secondary|Anti-Cytosine Phosphate Guanosine Oligodeoxynucleotide (CpG) Humoral Response (Phase I & II)|Analysis of immunogenicity for anti-CpG antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-CpG antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.|At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit|This analysis was not performed.||||||
1413997|NCT01149343|Secondary|Anti-Protein D Humoral Response (Phase I & II)|Analysis of immunogenicity for anti-PD antibodies was not performed, following negative results to the NCT00480025 study which assessed another study product from same technology platform. For this study, the main analysis of the dose-escalation Phase I segment was performed according to protocol when all patients enrolled in the Phase I segment had received the first 4 treatment doses and had completed Week 8. The main analysis of the Phase II segment was performed according to protocol when all patients had either completed the treatment until the end of Cycle 3 or had been withdrawn from the study treatment, with the exception of anti-PD antibody responses and PRAME-specific cellular responses which were not yet performed. All samples that had been collected but not yet tested were not tested by default, except if a scientific rationale remained relevant.|At Week 0, 4, 8, 12, 29, 51, 75, 99, 123, 147, 30 days after the last treatment administration for each patient (Week 199), with follow-up, 3, 6, 9 and 12 months after concluding visit|This analysis was not performed.||||||
1413998|NCT01149343|Secondary|Number of Patients With Best Overall Response, Including Mixed Response (MxR) and Slow Progressive Disease (SPD) Criteria (Phase I & II)|Tumor response was assessed by the RECIST criteria, where SD for target lesions refers to neither enough shrinkage to qualify for CR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more nom-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these. Mixed response is defined as at least 30% decrease in the LD occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise SD or PD status of the LD of target lesions were classified as “SD with target lesion regression” or “PD with target lesion regression”, respectively. New lesion(s) in otherwise PR status of the LD of target lesions were “PR with new lesion”.|At 30 days after the last treatment administration for each patient (Week 199)|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1413999|NCT01149343|Secondary|Number of Patients With Stable Disease (SD), Progressive Disease (PD), Mixed Response (MR) (Phase I & II)|Tumor response was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST), where stable disease for target lesions refers to neither enough shrinkage to qualify for complete response nor sufficient increase to qualify for progressive disease taking as references the smallest sum longest diameter (LD) since the treatment started. For non-targeted lesions it refers to persistence of one or more non-target lesions. Progressive disease is related to a clear increase of diameters of lesions taking as references the smallest diameters recorded since the treatment started OR the appearance of one or more new lesions OR both of these.|At 30 days after the last treatment administration for each patient (Week 199)|The analysis was performed on the Total Vaccinated Cohort, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414000|NCT01149343|Secondary|Number of Patients With Anti-PRAME Humoral Immune Response (Phase I & II)|A seropositive patient was a patient whose anti-PRAME antibody concentration was greater than or equal to (≥) the assay cut-off value of 12 ELISA units per milliliter (EL.U/mL). A seronegative patient was defined as a patient whose pre-treatment antibody concentration was below (<) the cut-off value. An anti-PRAME antibody responder was defined as: For a seronegative patient: a post-treatment antibody concentration ≥ the cut-off value; For a seropositive patient: a post-treatment antibody concentration ≥ twice the pre-treatment antibody concentration.|At Weeks 0, 4, 8, 10, 12, 29, 51, 75, 99, 123, 147 and conclusion visit at 30 days post last treatment administration (Week 199) for each patient|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414001|NCT01149343|Secondary|Percentage of Patients With Anti-PRAME Cellular (T-cell) Response (Phase I)|Cellular response was defined as: Geometric Mean Response (GMR) above the 2.68 cut-off value and at least a four-fold increase of PRAME- specific Cluster of Differentiation (CD) 4/8 T-cells. Considering that 2 studies failed to demonstrate clinical efficacy of recombinant protein based cancer vaccines, GSK decided in 2014 to stop the development and to stop recruitment in all the ongoing clinical studies. The decision was made to end the study (i.e., stopping patient enrollment, follow-ups, sample collection and analysis of samples for research purposes). Patients still on treatment at the time of the protocol amendment were offered to continue the administration of the study treatment until the last dose or until recurrence, whichever came first, or until the patient or the investigator decided to stop the study treatment. No further active protocol visit/contact was performed except for the concluding visit at Week 199, 30 days after the last treatment administration.|Up to Data Lock Point at Week 8|The analysis was performed on the Phase 1 subjects with available results up to Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Percentage of patients||95% Confidence Interval|Number
1414002|NCT01149343|Secondary|Number of Patients With Abnormal Hematological and Biochemical Laboratory Results Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [NEUC/D], [PLA/D] and [WBC/D] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414003|NCT01149343|Secondary|Number of Patients With Abnormal Hematological and Biochemical Results Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [LYMC/D] and [LYMC/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414004|NCT01149343|Secondary|Number of Patients With Lab Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [Hgb/I] and [HYP] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414005|NCT01149343|Secondary|Number of Patients With Laboratory Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [CRE/I] and [GGT/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414031|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96|CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
1414006|NCT01149343|Secondary|Number of Patients With Hematological and Biochemical Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to baseline parameter grades (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [AN], [AST/I] and [CRE/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414007|NCT01149343|Secondary|Number of Patients With Laboratory Abnormal Results Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Uknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [ALT/I] and [APH/I] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414008|NCT01149343|Secondary|Number of Patients With Laboratory Abnormalities Versus Baseline, by Maximum Grading|Laboratory abnormalities belong to hematological and biochemical parameters such as: activated partial thromboplastin time prolonged [APTTP], alanine aminotransferase increased [ALT/I], alkaline phoshatase increased [APH/I], anemia [AN], asparatate aminostransferase increased [AST/I], blood bilirubin increased [BB/I], creatinine increased [CRE/I], gamma glumatymtransferase increased [GGT/I], hemoglobin increased [Hgb/I], hypoalbuminemia [HYP], lymphocyte count decreased [LYMC/D], lymphocyte count increased [LYMC/I], neutrophil count decreased [ NEUC/D], platelet count decreased [PLA/D], white blood cell decreased [WBC/D]. Parameter grades (G0,1,2,3,4,Unknown) were compared to each baseline parameter grade (GUnknown,0,1,2,3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 of May 28, 2009 [http://evs.nci.nih.gov/ftp1/CTCAE]. This endpoint presents values for [APTTP] grading versus baseline parameter grading.|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414009|NCT01149343|Secondary|Number of Patients With Serious Adverse Events (SAEs), by Maximum Grading|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). SAEs were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414010|NCT01149343|Secondary|Number of Patients With Any Unsolicited Adverse Events (AEs), by Maximum Grading|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. The grading to be used by the investigators for the assessment of the severity of adverse events (AEs) was defined as the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE). Adverse Events were coded to the preferred term (PT) level by means of the Medical Dictionary for Regulatory Activities (MedDRA).|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414011|NCT01149343|Primary|Number of Patients With Best Overall Response to Study Treatment (Phase II)|The best overall response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). In general the patient's best response assignment depended on the achievement of both measurement and confirmation criteria. The best overall response includes the complete response (CR) defined as disappearance of all targeted/non-targeted lesions and partial response (PR) defined as at least 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD and persistence of one or more non-targeted lesion(s).|During the entire study period - up to Year 4 + 1 month post last study treatment administration|The analysis was performed on the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414045|NCT01148836|Secondary|Red Blood Cells||before and after three months of CoQ||||10^6 cells/µl||Standard Deviation|Mean
1414012|NCT01149343|Primary|Percentage of Patients With Anti-PReferentially Expressed Antigen of MElanoma (Anti-PRAME) Humoral Immune Response (Phase I)|A seronegative/seropositive patient for anti-PRAME antibodies was a patient with antibody concentration lower (<)/ higher than or equal to (≥) cut-off level. Humoral immune response was defined as a) if baseline concentration < cut-off level: post treatment concentration ≥ cut-off level, or b) if baseline concentration ≥ cut-off level: post treatment concentration at least twice the baseline value. Cut-off values for seropositivity (by enzyme-linked immunosorbent assay [ELISA]) were 12 ELISA Units per milliliter (EL.U/mL).|After the administration of dose 4, at Week 8|The analysis was performed on Phase 1 subjects with available results at Week 8, from the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Percentage of patients||95% Confidence Interval|Number
1414013|NCT01149343|Primary|Number of Patients With Dose-limiting Toxicity (Phase I)|"The dose-limiting toxicities (DLT) were defined as follows:~An Antigen-Specific Cancer Immunotherapeutic (ASCI) related or possibly ASCI related grade 3 or higher toxicity. Grade 3 myalgia, arthralgia, headache, fever, rigors/chills and fatigue (including lethargy, malaise and asthenia) persisting for 48 hours despite therapy.~An ASCI related or possibly ASCI related grade 2 or higher allergic reaction occurring within 24 hours following the ASCI administration.~An ASCI related or possibly ASCI related decrease in renal function, with a creatinine clearance lower than (<) 40 milliliters per minute (mL/min).~An ASCI-related or possibly ASCI-related symptomatic and confirmed adrenal insufficiency. The grading used was defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 3 DLT = severe DLT. Related = DLT considered by investigator as possibly related to product administration."|During the study treatment (up to Year 4), for all patients|The analysis was performed on Phase 1 subjects from the Total treated population, which included all enrolled patients who have received at least one study dose injection.|||Participants|||Count of Participants
1414014|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini–Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.~Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|3 Months|Not all participants completed 3 month follow up neurocognitive testing.|||Scores on a scale||Standard Deviation|Mean
1414015|NCT01149148|Primary|Mini Mental State Examination (MMSE)|"The Mini–Mental State Examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment at a specific time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. MMSE = Mini Mental State Exam - measures general orientation and mental status.~Scores on a scale range from 0 - 30. Scores 23 and below are indicative of problems."|Baseline||||scores on a scale||Standard Deviation|Mean
1414016|NCT01149057|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
1414017|NCT01149057|Secondary|Participant Assessment of Pain (VAS)|"The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated No pain, and the right endpoint (100) indicated Unbearable pain. Higher score indicated higher pain."|Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||mm||Standard Deviation|Mean
1414018|NCT01149057|Secondary|Erythrocyte Sedimentation Rate||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||millimeter per hour||Standard Deviation|Mean
1414019|NCT01149057|Secondary|C-reactive Protein Level||Baseline; Weeks 8, 16, 24, 36 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||milligram per deciliter||Standard Deviation|Mean
1414020|NCT01149057|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96||Baseline; Weeks 20, 44, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||gram per deciliter||Standard Deviation|Mean
1414021|NCT01149057|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96|ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||percentage of partcipants|||Number
1414022|NCT01149057|Secondary|Change From Baseline in SJC At Weeks 24, 48, 72, and 96|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.|||swollen joints||Standard Deviation|Mean
1414023|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
1414024|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
1414025|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
1414026|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|Per Protocol (PP) population: all participants who completed the study. Number of participants analyzed=participants with available data for this outcome. Here 'n' signifies the participants with available data for specified time point.|||units on a scale||Standard Deviation|Mean
1414027|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 96|ITT population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1414028|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 72|ITT population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1414029|NCT01149057|Primary|Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 48|ITT population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1414030|NCT01149057|Secondary|Change From Baseline in TJC At Weeks 24, 48, 72, and 96|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from baseline indicated improvement.|Baseline; Weeks 24, 48, 72 and 96|ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.|||tender joints||Standard Deviation|Mean
1414046|NCT01148836|Primary|Right Atrial Pressure||before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||mmHg||Standard Deviation|Mean
1414047|NCT01148836|Primary|Tricuspid Regurgitation Grade|Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)|before and after three months of CoQ|Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q|||units on a scale||Standard Deviation|Mean
1414032|NCT01149057|Secondary|Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96|SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter [cm]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
1414033|NCT01149057|Secondary|Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96|The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline <-1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline <-0.6 to greater than or equal to (≥) -1.2.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
1414034|NCT01149057|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score <2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
1414035|NCT01149057|Secondary|Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96|Remission was defined as DAS28 score less than (<) 2.6. The DAS28 score was a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity (visual analog scale [VAS]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity.|Weeks 24, 48, 72 and 96|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.|||participants|||Number
1414036|NCT01149057|Secondary|Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study|BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation [SD] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.|Baseline, End of the study (up to Week 100)|ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number of participants with available data for specified category.|||T-score||Standard Deviation|Mean
1414037|NCT01149057|Primary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline, Week 24|ITT population. Number of participants analysed=participants with available data for this endpoint. Here, 'n' signifies participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
1414038|NCT01148979|Primary|Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks.|The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms.|Baseline to 4 weeks of treatment|All participants who completed all 4 weeks on both treatments (i.e., Placebo and Vyvanse) were included in the analysis.|||scores on a scale||Standard Deviation|Mean
1414039|NCT01148862|Primary|The Primary Treatment Comparison is the Evaluation of the Severity (Milligrams Per Deciliter) of Induced Hypoglycemia.|Severity (Milligrams per Deciliter) of induced hypoglycemia (YSI < 70 Milligrams per Deciliter) is defined as 70 Milligrams per Deciliter minus absolute lowest blood sugar level|approximately 8 hours per induction experiment||||Milligrams per Deciliter||Standard Deviation|Mean
1414040|NCT01148862|Primary|The Primary Treatment Comparison is the Evaluation of the Duration (Minutes) of Induced Hypoglycemia.|Duration (minutes) of induced hypoglycemia (YSI < 70 mg/dL)|approximately 8 hours per induction experiment||||minutes||Standard Deviation|Mean
1414041|NCT01148836|Secondary|Red Blood Cell Distribution Width||before and after three months of CoQ||||percentage of sizes of red blood cells||Standard Deviation|Mean
1414042|NCT01148836|Secondary|Mean Corpuscular Hemoglobin||before and after three months of CoQ||||pg||Standard Deviation|Mean
1414043|NCT01148836|Secondary|Hematocrit||before and after three months of CoQ||||% of red blood cell||Standard Deviation|Mean
1414044|NCT01148836|Secondary|Hemoglobin||before and after three months of CoQ||||g/dl||Standard Deviation|Mean
1414052|NCT01148771|Secondary|Probability of Target Attainment (PTA)|After simulating 5000 patients receiving each dosing regimen, the probability of achieving free drug concentrations above an MIC of 0.25 mcg/mL and 0.5mcg/mL for at least 40% of the dosing interval (40% fT>MIC) is calculated at each MIC dilution.|Simulated Steady-State Exposure|The probability of achieving 40% T>MIC is reported at a MIC of 0.25mcg/mL and 0.5mcg/mL respectively.|||% of 5000 simulated patients|Participants||Number
1414053|NCT01148771|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The following laboratory assessments will be make before and after participation in the study to determine if objective changes occurred: blood pressure, pulse rate, temperature, complete blood count with differential, platelet count, blood urea nitrogen, serum creatinine, liver function panel [aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase], total bilirubin, and urinalysis with microscopy. Monitoring of other pathologic or unintended changes in structure (signs),or function (symptoms) of the body associated with participation in the study will occur.|3 days||||participants|||Number
1414054|NCT01148771|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady-State (After 3rd Dose)|Cmax is measured at 5 minutes after the beginning of the infusion for the 5 minute IV bolus dosage regimen and at 30 minutes after the beginning of the infusion for the 30 minute infusion dosage regimen.|5 or 30 minutes post start of infusion on Day 3|Each participant received ertapenem as a 5 minute infusion and as a 30 minute infusion, only in different order due to cross-over design. Data for all participants receiving each dosage regimen are included in each arm for results.|||mcg/mL||Standard Deviation|Mean
1414055|NCT01148745|Secondary|Serum Ferritin|Serum ferritin values were measured at all visits|7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)||||g/mL||Full Range|Median
1414056|NCT01148745|Secondary|Transferrin Saturation (TSAT)|Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100|7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.||||percent||Full Range|Median
1414057|NCT01148745|Primary|Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize|TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.|pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration||||weeks|||Number
1414058|NCT01148693|Primary|Number of Participants With Cholangitis|After Endoscopic Retrograde CholangioPancreatography (ERCP) in 3 following days we check all participants for syptoms of cholangitis (fever, chills, right upper qudrant (RUQ) pain, leukocytosis) and ruling out other diagnoses than cholangitis|72 hours||||participants|||Number
1414059|NCT01148563|Secondary|U.S. Dollars Per Person-year|(emergency department costs + inpatient costs) / person-year|12 months|All heart failure patients included in the study|||U.S. dollars per person-year||Standard Error|Mean
1414060|NCT01148563|Primary|Events Per Person-year|(Number of emergency department visits + number of inpatient stays) / person-year|12 months|Used an Intention to Treat (ITT) Analysis. Missing outcome data were imputed as necessary.|||events/person-year||95% Confidence Interval|Mean
1414061|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo by Fridericia’s Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia’s method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."|||QTcF (msec)||Standard Deviation|Least Squares Mean
1414062|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Fridericia’s Corrected Interval (QTcF) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Fridericia’s method (QTcF) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTcF (msec)||Standard Deviation|Least Squares Mean
1414063|NCT01148537|Secondary|The Average Differences From Baseline Between Moxifloxacin and Placebo of Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett’s method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."|||QTcB (msec)||Standard Deviation|Least Squares Mean
1414239|NCT01147497|Secondary|Need for Additional Pain Medications After Insertion of the IUD||assessed one week after insertion|Data were not collected for this outcome measure. The follow-up questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about medication use) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.||||||
1414064|NCT01148537|Secondary|The Average Differences From Baseline Between BTDS and Placebo by Bazett Corrected QT Interval (QTcB) on Day 6 and Day 13|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc (QT interval corrected for heart rate) data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected by Bazett’s method (QTcB) msec."|Baseline to Day 6 and Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTcB (msec)||Standard Deviation|Least Squares Mean
1414065|NCT01148537|Secondary|The Average Differences Between Moxifloxacin vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation~For the comparison of moxifloxacin to placebo (N = 88), the subjects randomized to BTDS were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
1414066|NCT01148537|Primary|The Comparison of Moxifloxacin to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Interval Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of moxifloxacin to placebo (N=88), the subjects randomized to BTDS were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
1414067|NCT01148537|Secondary|The Average Differences Between BTDS vs Placebo From Baseline by Interval Corrected From Within-subject Data (QTci) on Day 6|"QT and RR data were determined for each of 4 ECGs over an approximate 10-minute interval at each nominal time point. The average QT and QTc data from the replicate ECGs at each nominal time point were calculated. The average QT and QTc data over the 2 pretreatment days were used as the baseline QT and QTc values.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 6|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
1414068|NCT01148537|Primary|The Comparison of BTDS to Placebo Transdermal System (TDS): the Average Difference From Baseline Using QT Corrected From Within-subject Data (QTci) on Day 13|"Observed time from start of the QRS complex to end of the T wave (QT), and the time between the 2 R waves (RR) data for each of 4 electrocardiographs (ECGs) over an approximate 10-minute interval at each nominal time point. The average QT and QTc data over the 2 pretreatment days were used as the baseline.~Observed time from start of the QRS complex to end of the T wave (QT); interval corrected for heart rate (QTc) msec; interval corrected from within-subject data (QTci) msec."|Baseline to Day 13|"The full analysis population for ECGs (N = 131) was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose digital QT/QTc evaluation.~For the comparison of BTDS to placebo (N = 88), the subjects randomized to moxifloxacin were excluded."|||QTci (msec)||Standard Deviation|Least Squares Mean
1414069|NCT01148524|Primary|Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|18 months after last vaccination V72P10 study.|Analysis was performed on the MITT dataset.|||UI/mL||95% Confidence Interval|Geometric Mean
1414070|NCT01148524|Primary|Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.|The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.|month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set. Naive group was not reported for this endpoint since GMR data for this group were not collected (subjects were enrolled in this study and no GMT values at 1m and 18 m after last vaccination in V72P10 are available).|||Geometric mean ratio||95% Confidence Interval|Geometric Mean
1414071|NCT01148524|Primary|Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the MITT data set.Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1423348|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Eosinophils|Change from baseline|Baseline and 52 week after||||percentage of Eosinophils||Standard Deviation|Mean
1414072|NCT01148524|Primary|Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.|The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).|month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.|Analysis was performed on the modified intention-to-treat (MITT) data set, i.e. all subjects who provided evaluable serum samples. Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.|||Percentage of subjects||95% Confidence Interval|Number
1414073|NCT01148511|Secondary|Quality of Life|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient’s subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.|Visits 2, 6, 9, 12, and 15 (up to 12 months)|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Units on a scale||Full Range|Median
1414074|NCT01148511|Secondary|Change in Central Retinal Thickness From Baseline to Month 12|Retinal thickness was measured using Optical Coherence Tomography (OCT).|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||µm||Full Range|Median
1414075|NCT01148511|Secondary|Follow-up Duration|Follow-up duration was defined as the number of days from Baseline to study discontinuation.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Days||Full Range|Mean
1414076|NCT01148511|Secondary|Number of Visits||Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Visits||Full Range|Median
1414077|NCT01148511|Secondary|Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Percentage of patients|||Number
1414078|NCT01148511|Primary|Change in Letter Count From Baseline to Month 12|Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||Letters||Full Range|Median
1414079|NCT01148511|Primary|Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12|Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.|Baseline to Month 12|Per protocol population: All patients who were evaluated at Baseline and at 12±2 months. Patients who discontinued from the study were not included in the per protocol population.|||logMAR||Full Range|Median
1414080|NCT01148420|Primary|Cessation of Bleeding Within 5 Days|Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5|3-5 days||||participants|||Number
1414081|NCT01148420|Secondary|Satisfaction and Willingness to Recommend Treatment|Participants were asked whether they would recommend this treatment to a friend|End of the trial; up to day 5||||participants|||Number
1414082|NCT01148420|Secondary|Patient Perception of the Acceptability of the Treatment|Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent.|End of the trial; up to day 5||||units on a scale||Full Range|Median
1414083|NCT01148056|Secondary|Accuracy|To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
1414084|NCT01148056|Secondary|Quantity of Circulating Tumor Cells|To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
1414085|NCT01148056|Secondary|Tissue Microarray|To determine changes in the tumor induced by radiation as assessed by tissue microarray.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
1414086|NCT01148056|Secondary|Surgical Complication Rate|To determine the surgical complication rate in patients who received preoperative radiation therapy.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
1414087|NCT01148056|Secondary|Pelvic Control Rate|To determine the pelvic control rate of patients after short course radiation therapy and surgery.|2 years|Study was closed early due to poor accrual. Analyses not completed.||||||
1414536|NCT01144052|Secondary|MRI Parameters|Number of new T2-hyperintense lesions, Number of Gd-enhancing lesions on T1-weighted images. Assessments at month 3, 6, 9, 12, 18, 24.|12 months|All enrolled and randomized patients were analyzed.|||Lesions||Full Range|Median
1414089|NCT01148017|Secondary|Number of Subjects Reporting Unsolicited AEs and SAEs|Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.|Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).|Analysis was done on the Post MenACWY at 60 months safety set ie, all subjects who received a vaccination at 60 months and were assessed for postvaccination safety, and on the Post MenACWY at 40 Months Safety Set, ie, the Naive subjects enrolled at 40 months of age who received vaccination at 40 months and were assessed for post vaccination safety.|||Number of subjects|||Number
1414090|NCT01148017|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity|"Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.~Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs."|From day 1 to 7 after vaccination.|Analysis was done on the Solicited Safety Set (from 6 hours to day 7), ie, all subjects who received a vaccination at 60 months and provided postvaccination solicited safety data.|||Subjects|||Number
1414091|NCT01148017|Secondary|Percentage of Subjects With Seroresponse at 1 Month Post-vaccination|"The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.~Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4."|Visit 11, 1 month after vaccination.|Analysis was done on the PPS Post-MenACWY-CRM.|||Percentage of subjects||95% Confidence Interval|Number
1414092|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination|The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.|Visit 11, 1 month after vaccination.|Analysis was done on the PPS-Immunogenicity after one dose of MenACWY-CRM (PPS Post-MenACWY-CRM), ie, all subjects in the enrolled population who correctly received the vaccine, provided at least one evaluable serum sample at the relevant time points and whose assay result was available for at least one serogroup with no major protocol deviation.|||Percentages of subjects||95% Confidence Interval|Number
1414093|NCT01148017|Secondary|hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age|The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.|||Titers||95% Confidence Interval|Geometric Mean
1414094|NCT01148017|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-months of age.|Analysis was done on the PPS 40-month persistence.|||Titers||95% Confidence Interval|Geometric Mean
1414095|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age.|Analysis was done on the PPS 60-Month persistence.|||Percentages of subjects||95% Confidence Interval|Number
1414096|NCT01148017|Secondary|Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age|The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9, 40 months of age.|Analysis was done on the PPS 40-month persistence.|||Percentages of subjects||95% Confidence Interval|Number
1414097|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 10, 60 months of age|Analysis was done on the Per Protocol Set 60-Month persistence (PPS 60-Month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 60-month of age visit and had no major protocol deviation.|||Percentages of subjects||95% Confidence Interval|Number
1414098|NCT01148017|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y|The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.|Visit 9 (continuation from the parent study), 40-month visit.|Analysis was done on the Per Protocol Set 40-month persistence (PPS 40-month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviation.|||Percentages of subjects||95% Confidence Interval|Number
1414099|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment|"The subject was asked to rate his global evaluation of the efficacy of treatment using the following 5-point scale:~0=not at all effective~a little bit effective~moderately effective~quite a bit effective~extremely effective."|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
1414100|NCT01147926|Secondary|Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment|Subject was asked to rate the severity of his constipation using a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
1414101|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
1414102|NCT01147926|Secondary|Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of subjects|||Number
1414103|NCT01147926|Secondary|Days With Rescue Medication Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||Days/week||Standard Deviation|Mean
1414104|NCT01147926|Secondary|Bisacodyl Tablets Taken Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||Tablets/week||Standard Deviation|Mean
1414105|NCT01147926|Secondary|Time to First SCBM After Investigational Product Intake on Day 1||Day 1|mITT.|||hours||95% Confidence Interval|Median
1414106|NCT01147926|Secondary|Percent SBM With Sensation of Complete Evacuation||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
1414107|NCT01147926|Secondary|Percent SCBM With No Straining and Severe/Very Severe Straining|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
1414108|NCT01147926|Secondary|Percent SBM With a Consistency of Normal and Hard/Very Hard|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
1414109|NCT01147926|Secondary|SCBM Per Week||Over 12 week treatment period|mITT. Not all subjects in the mITT population had data for this outcome.|||SCBM/week||Standard Deviation|Mean
1414110|NCT01147926|Secondary|Percentage of Subjects With an Increase of at Least 1 SCBM Per Week||Over 12 week treatment period|mITT|||percentage of subjects|||Number
1414111|NCT01147926|Secondary|Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period||Over 12 week treatment period|mITT|||percentage of subjects|||Number
1414112|NCT01147926|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 12 week treatment period|Modified Intent-to-treat Population (mITT) included all subjects randomized into the study except those excluded due to a major good clinical practice (GCP) breach at one site, who took at least 1 dose of the investigational product.|||percentage of subjects|||Number
1414113|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 8.5 up to study end (one month post Year 10 booster vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
1414114|NCT01147900|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject..|At Year 8.5|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
1414125|NCT01147900|Primary|Concentrations for Anti-PT, Anti-PRN and Anti-FHA Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1414115|NCT01147900|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination.|During the 31-day (Days 0-30) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
1414116|NCT01147900|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and fever [defined as axillary temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||subjects|||Number
1414117|NCT01147900|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of Boostrix™ vaccine, any formulation, for whom data were available.|||Participants|||Count of Participants
1414118|NCT01147900|Primary|Number of Booster Responders to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens.|"A booster responder to PT/PRN antigens was defined as either a vaccinated subject seronegative at analysis baseline (Year 10) with anti-PT/anti-PRN antibody concentration greater than or equal to (≥) 5 EL.U/mL at one month post Year 10 booster vaccination, or as a vaccinated subject seropositive at analysis baseline (Year 10) and with anti-PT/anti-PRN antibody concentration with at least a 2-fold increase at one month post Year 10 booster vaccination.~A seronegative/seropositive subject was defined as a vaccinated subject with anti-PT/anti-PRN antibody concentration ≥/< 5 EL.U/mL."|At 1 month post Year 10 booster vaccination|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1414119|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1414120|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1414121|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1414122|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10 pre booster vaccination (PRE) and at 1 month post Year 10 booster vaccination (POST)|Analysis was done on the According-to-Protocol for immunogenicity at Year 10, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine, any formulation (at least 9.5 years after the dose administered in GSK263855/029 study) and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1414123|NCT01147900|Primary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 5 EL.U/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1414124|NCT01147900|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies.|A seropositive subject for anti-PT/anti-FHA/anti-PRN antibodies was defined as a vaccinated subject who had anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||Participants|||Count of Participants
1455517|NCT00811317|Secondary|Percentage of Time Spent With BG > 180 mg/dl||24 hours||||percentage of time||Standard Deviation|Mean
1414126|NCT01147900|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibodies.|A seropositive subject for anti-PT/anti-PRN/anti-FHA antibodies was defined as a vaccinated subject who had anti-PT/anti-PRN/anti-FHA antibody concentrations greater than or equal to (≥) 5 Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||Participants|||Count of Participants
1414127|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||IU/mL||95% Confidence Interval|Geometric Mean
1414128|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus.|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-D/anti-T antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 10|The analysis was performed on the According To Protocol cohort for persistence at Year 10, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 10.|||Participants|||Count of Participants
1414129|NCT01147900|Primary|Concentrations for Anti-D and Anti-T Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL for all antibodies assessed.|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5 , which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||IU/mL||95% Confidence Interval|Geometric Mean
1414130|NCT01147900|Primary|Number of Seroprotected Subjects Against Diphtheria and Tetanus|A subject seroprotected against diphtheria/tetanus was defined as a vaccinated subject who had an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentration greater than or above (≥) 0.1 international units per milliliter (IU/mL).|At Year 8.5|The analysis was performed on the According To Protocol cohort for persistence at Year 8.5, which included all subjects who had received no additional dose of diphtheria, tetanus or pertussis vaccine other than the Boostrix™ booster dose received in the GSK263855/029 study, and for whom serological results were available at Year 8.5.|||Participants|||Count of Participants
1414131|NCT01147874|Secondary|Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Primary PsA diagnosis made by rheumatologist based on physical examination, medical history and laboratory test results. Secondary PsA diagnosis made by rheumatologist based on physical examination and medical history only. For both, numerator was number of participants with “No” answer to question concerning previous diagnosis of PsA at Visit 1 (dermatology visit) and were subsequently classified as positive by rheumatologist; denominator was total number of participants evaluated for PsA.|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.|||Percentage of participants||95% Confidence Interval|Number
1414132|NCT01147874|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history and physical examination as the basis for the diagnosis.|Week 0 through Week 8|FAS population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.|||Percentage of participants||95% Confidence Interval|Number
1414133|NCT01147874|Primary|Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results|PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history, physical examination and laboratory results as the basis for the diagnosis.|Week 0 through Week 8|Full analysis set (FAS) population included all randomized participants with an answer to the question at Visit 1 (dermatology visit) about previous diagnosis of PsA by a rheumatologist and had an assessment of PsA during the study by a rheumatologist based on medical history, physical examination and laboratory results.|||Percentage of participants||95% Confidence Interval|Number
1414134|NCT01147848|Other Pre-specified|Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at Day 168|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). The second part is a 20 centimeter VAS that has endpoints labelled best imaginable health state and worst imaginable health state anchored at 100 and 0, respectively. Participants were asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS that best represents their own health on that day. Analysis was performed using ANCOVA with covariates of Baseline VAS score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||scores on a scale||Standard Error|Least Squares Mean
1414537|NCT01144052|Secondary|Severity of Relapses|Change of Expanded Disability Status Scale (EDSS 1-10). Higher values represent a worser outcome.|12 months vs baseline||||units on a scale||Full Range|Median
1414135|NCT01147848|Other Pre-specified|"Percentage of Participants With No Problems in the EQ-5D Descriptive System Dimensions at Day 168/Week 24"|"The EQ-5D is a standardized, 2-part, self-assessment instrument, designed for self-completion, used to measure health outcome. The first part consists of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is measured by a three-point Likert scale (1=no problems, 2=some problems and 3=severe problems). Respondents are asked to choose one level that reflects their own health state today for each of the five dimensions."|Day 168/Week 24|ITT Population. Only those participants available at the indicated time point were assessed.|||percentage of participants|||Number
1414136|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score for Participants 12 Years of Age and Older (AQLQ + 12)|"The AQLQ is a disease-specific, self-administered quality of life (QOL) questionnaire developed to evaluate the impact of asthma treatments on the QOL of asthma sufferers. The AQLQ contains 32 items in four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The response format consists of a 7-point scale: a value of 1 indicates total impairment; a value of 7 indicates no impairment. The AQLQ total score is defined as the average of the scores from all 32 questions, provided at least 90% of the questions have been answered; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Change from Baseline was calculated as the Day 168 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline total AQLQ score, country, sex, age, and treatment."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
1414137|NCT01147848|Other Pre-specified|Number of Healthcare Contacts Related to Asthma or the Treatment of Asthma From Baseline to Day 168|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (to the general ward [GW] or the intensive care unit [ICU]) that were associated with asthma exacerbations were recorded.|Baseline to Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||visits per participant||Standard Deviation|Mean
1414138|NCT01147848|Other Pre-specified|Change From Baseline in Asthma Control Test (ACT) Scores at Day 168|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the Day 168 value minus the Baseline value."|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed. Analysis was performed using ANCOVA with covariates of Baseline total ACT score, country, sex, age, and treatment.|||Scores on a scale||Standard Error|Least Squares Mean
1414139|NCT01147848|Other Pre-specified|Baseline FEV1 by Completion Status|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.|Baseline|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Deviation|Mean
1414140|NCT01147848|Secondary|Change From Baseline in Trough FEV1 at Day 168|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . Trough FEV1 is defined as the pre-dose measurement on Day 168/Week 24. Any missing data at Day 168/Week 24 was imputed using the last observation carried forward (LOCF). Baseline was the pre-dose measurement on Day 1. Change from Baseline was calculated as the pre-dose measurement on Day 168/Week 24 minus the Baseline value.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1414141|NCT01147848|Secondary|Number of Participants Obtaining a >=12% and >=200 mL Increase From Baseline in FEV1|The number of participants obtaining a >=12% and >=200 mL increase from Baseline in FEV1 (the maximal amount of air that can be forcefully exhaled in one second) was evaluated at 12-hours post-dose and at 24-hours post-dose on Day 168.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
1414142|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours at Day 168|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline and Day 168 was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Deviation|Mean
1414143|NCT01147848|Secondary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-4 Hours Post First Dose (at Randomization)|The weighted mean serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) over 0-4 hours post-dose at Baseline was derived using actual times and using the pre-dose assessment as the 0 hour measurement. Change from Baseline was calculated as the weighted mean of the 4-hour serial FEV1 measures on Day 1 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Randomization|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1414209|NCT01147653|Secondary|Modified Ashworth Scale at Baseline|The Modified Ashworth Scale uses a 6 point scale (range 0, 1, 1+, 2, 3, or 4) to measure spasticity in 5 body regions (central, right upper extremity, left upper extremity, right lower extremity, and left lower extremity). Scores of 0 indicate no increase in muscle tone whereas a score of 4 indicates rigidity in flexion or extension.|Baseline|Patients are classified by their maximum score, regardless of body region.|||Participants|||Count of Participants
1414144|NCT01147848|Secondary|Number of Participants With the Indicated Time to Onset of Bronchodilator Effect at Day 1|Time to onset of bronchodilator effect at Day 1 is defined as the actual time during the 4-hour serial FEV1 (the maximal amount of air that can be forcefully exhaled in one second) measurements that the participant first meets or exceeds a 12% and 200 mL increase over Baseline and was derived at Day 1 only. Time to onset was calculated over 0 to 4 hours (5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours) post-dose. Participants who never exceeded a 12% and 200 mL increase over Baseline were censored at the actual time of their last FEV1 measurement.|Baseline to Day 1|ITT Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
1414145|NCT01147848|Secondary|Serial FEV1 (0-24 Hours)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second . The pre-dose FEV1 assessment and the individual serial FEV1 assessments at Day 168/Week 24 at the indicated time points (pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 11 hours, 12 hours, 12.5 hours, 13 hours, 14 hours, 16 hours, 20 hours, 23 hours, and 24 hour s) were summarized.|Day 168|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Deviation|Mean
1414146|NCT01147848|Primary|Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, on Day 168/Week 24. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 168/Week 24 minus the Baseline value. Baseline was the pre-dose measurement on Day 1. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Day 168/Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
1414147|NCT01147822|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of confirmed response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of response until the earliest date of disease progression/death (up to 38 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.|||Months||95% Confidence Interval|Median
1414148|NCT01147822|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian). Only those participants who experienced either a confirmed CR or a PR were analyzed.|||Weeks||95% Confidence Interval|Median
1414149|NCT01147822|Secondary|Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC|The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) was evaluated by an independent review per RECIST, Version 1.|From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)|ITT Population (Asian)|||Participants|||Number
1414150|NCT01147822|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization until death (up to 44 months)|ITT Population (Asian)|||Months||95% Confidence Interval|Median
1414151|NCT01147822|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter (LD) recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From randomization to the earliest date of disease progression or death (up to 39 months)|Intent-to-Treat (ITT) Population (Asian): All randomized participants (par) from Study VEG113078 and Study VEG108844 who enrolled in Japan, China, Taiwan, and Korea.|||Months||95% Confidence Interval|Median
1414152|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to >=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population|||Days||Standard Deviation|Mean
1414538|NCT01144052|Secondary|Proportion of Relapse Free Patients||12 months||||participants|||Number
1414539|NCT01144052|Secondary|Number of Relapses||12 months||||number of events|||Number
1414153|NCT01147809|Secondary|Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population|||Days||Standard Deviation|Mean
1414154|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 1 to Cycle 6|ITT Population: Participants with at least one period of thrombocytopenia where duration could be calculated.|||Days||Standard Deviation|Mean
1414155|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II|As per the CTCAE version 4.0, participants with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets <150Gi/L) at least once within cycle are presented in the category title as n=X,X.|Cycle 1 to Cycle 6|ITT Population|||Participants|||Number
1414156|NCT01147809|Secondary|Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 1 Day 1 to last assessment in Cycle 6|ITT Population:Participants with platelet count data in at least one cycle in the study.|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
1414157|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase II|Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).|Cycle 1 to Cycle 6|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
1414158|NCT01147809|Secondary|Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II|Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
1414159|NCT01147809|Secondary|Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.|Day 15 (averaged across cycles 1 to 6)|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
1414160|NCT01147809|Secondary|Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.|Day 8 (averaged across cycles 1 to 6)|ITT Population|||Giga (10^9) cells per liter (G cells/L)||Geometric Coefficient of Variation|Geometric Mean
1414240|NCT01147497|Secondary|Ease of Insertion and Presence of Pain in Nulliparous Women Versus Nulligravid Women||assessed immediately following insertion|Data were not collected for this outcome measure. The participant questionnaire developed for this study was piloted prior to study initiation and some questions (including questions about prior pregnancies) were removed for clarity, to focus on the primary study aims, and to reduce participant burden.||||||
1414161|NCT01147809|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|C1D4|Safety Population|||participants|||Number
1414162|NCT01147809|Secondary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II|ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).|Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1 and C17D1|Safety Population|||participants|||Number
1414163|NCT01147809|Secondary|Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II|Number of participants with at least 1 assessment of change from Baseline in creatinine, with increase >=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population|||participants|||Number
1414164|NCT01147809|Secondary|Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase II|"Clinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as Any grade increase, Increase to Grade 3 or Grade 4. Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles)."|After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up|Safety Population|||participants|||Number
1414165|NCT01147809|Secondary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).|After baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
1414166|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.|Cycle 1 to Cycle 6|ITT Population|||Dose Intensity (%)||Standard Deviation|Mean
1414167|NCT01147809|Secondary|Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.|Cycle 1 to Cycle 6|ITT Population|||Participants|||Number
1414168|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II|Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).|Cycle 1 to Cycle 6|ITT Population|||Participants|||Number
1414169|NCT01147809|Secondary|Number of Participants Requiring a Platelet Transfusion in Phase II|Platelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.|Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation|ITT Population|||Participants|||Number
1414170|NCT01147809|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase II|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.|Screening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-up|ITT Population: Participants with at least one visit within the cycle.|||Participants|||Number
1414171|NCT01147809|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase II|AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)|Safety Population|||Participants|||Number
1414172|NCT01147809|Secondary|Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I|Any delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.|All time on chemotherapy treatment|Safety Population|||Participants|||Number
1414173|NCT01147809|Secondary|Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I|Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m^2) within Cycle *100/ Total Scheduled dose (mg/m^2) in Cycle 1; wherein Actual Dose (mg/m^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).|Cycle 1 to Cycle 6|Safety Population|||Dose Intensity (%)||Standard Deviation|Mean
1414174|NCT01147809|Secondary|Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (>100Gi/L or >150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to >=100Gi/L or >=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population|||Days||Standard Deviation|Mean
1414175|NCT01147809|Secondary|Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population|||Days||Standard Deviation|Mean
1414176|NCT01147809|Secondary|Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts|Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.|Cycle 2 to Cycle 6|Safety Population. Participants experiencing thrombocytopenia with subsequent increase in platelet count to >=150Gi/L are included.|||Days||Standard Deviation|Mean
1414177|NCT01147809|Secondary|Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet Count|As per the CTCAE version 4.0, par. with a platelet count <LLN but >=75 x 10^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count <75Gi/L, but >=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count <50Gi/L, but >=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count <25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets <150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.|Cycle 1 to Cycle 6|Safety Population|||Participants|||Number
1414178|NCT01147809|Secondary|Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I|The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.|All assessments from Cycle 2 Day 1 to last assessment in Cycle 6|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
1414179|NCT01147809|Secondary|Platelet Count Nadir for Each Chemotherapy Cycle in Phase I|Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|Cycle 1 to Cycle 6|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
1414180|NCT01147809|Secondary|Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I|Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
1414181|NCT01147809|Secondary|Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I|Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).|C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1,C4D8, C4D15, C5D1,C5D8, C5D15, C6D1,C6D8 and C6D15|Safety Population|||Giga (10^9) cells per liter (G cells/L)||Standard Deviation|Mean
1414182|NCT01147809|Primary|Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II|Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).|Day 1 (averaged across cycles 1 to 6)|Intent-to Treat (ITT) Population: all randomized participants.|||Giga (10^9) cells per liter (Gi/L)||Geometric Coefficient of Variation|Geometric Mean
1414183|NCT01147809|Primary|Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|C2D4, C2D8, C5D8, C6D15|Safety Population|||Participants|||Number
1414184|NCT01147809|Primary|Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I|ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.|Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15|Safety Population|||Participants|||Number
1414185|NCT01147809|Primary|Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I|The number of participants with at least 1 change from Baseline in creatinine, with an increase >=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
1414540|NCT01144052|Secondary|Number of Participants With Relapses||12 months|All enrolled and randomized patients were analyzed.|||participants|||Number
1414186|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I|Clinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
1414187|NCT01147809|Primary|Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I|Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).|After Baseline (C1D1), on-treatment and 30 day follow-up|Safety Population|||Participants|||Number
1414188|NCT01147809|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I|AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.|From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)|Safety Population|||Participants|||Number
1414189|NCT01147744|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period|The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).|Upto 8 Weeks|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Participants|||Count of Participants
1414190|NCT01147744|Secondary|Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period|The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Night-time number of inhalations||Standard Error|Least Squares Mean
1414191|NCT01147744|Secondary|Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period|The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Day-time number of inhalations||Standard Error|Least Squares Mean
1414192|NCT01147744|Secondary|Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period|Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Night-time symptom scores on a scale||Standard Error|Least Squares Mean
1423349|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Platelet Count|Change from baseline|Baseline and 52 week after||||*10000/μl||Standard Deviation|Mean
1414193|NCT01147744|Secondary|Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period|Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Day-time symptom scores on a scale||Standard Error|Least Squares Mean
1414194|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period|The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of rescue-free nights||Standard Error|Least Squares Mean
1414195|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period|The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of rescue-free days||Standard Error|Least Squares Mean
1414196|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant’s responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of symptom-free nights||Standard Error|Least Squares Mean
1414197|NCT01147744|Secondary|Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period|Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant’s responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants.|Baseline up to Week 8|ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record.|||Percentage of symptom-free days||Standard Error|Least Squares Mean
1414198|NCT01147744|Secondary|Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period|The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).|Baseline up to Week 8|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Liters per minute||Standard Error|Least Squares Mean
1414199|NCT01147744|Secondary|Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period|Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants)|Baseline up to Week 8|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Liters per minute||Standard Error|Least Squares Mean
1414217|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Mobility Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Mobility score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.|||units on a scale||Full Range|Median
1455518|NCT00811317|Secondary|Nadir Blood Glucose Level for Each Hypoglycemic Event||24 hours||||mg/dl|||Number
1414200|NCT01147744|Primary|Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)|Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.|Baseline and Week 8|ITT population. When possible, data from participants who withdrew prematurely from the study were included in the analyses. Any evaluable subject whose FEV1 measurement at Week 8 was missing was included in the analysis by imputation, using the preceding non-missing FEV1 value (last observation carried forward [LOCF]).|||Liters||Standard Error|Least Squares Mean
1414201|NCT01147653|Post-Hoc|Change in Whole Brain Connectivity Measured by Diffusion Tensor Magnetic Resonance Imaging (MRI) of All Subjects 1 Year Post-infusion With Autologous UCB|Change in whole brain connectivity measured by diffusion tensor magnetic resonance imaging (MRI). Changes in connectivity are normalized to white matter volume.|1 year post-infusion with autologous umbilical cord blood|This group combines patients who received Autologous Umbilical Cord Blood whether at baseline or 1 year post-infusion with Placebo and is limited to patients without morphologic brain abnormalities that prevented accurate anatomical image parcellation. Low/High dose is defined as the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.|||Number of connections x10e5||Standard Deviation|Mean
1414202|NCT01147653|Post-Hoc|Peabody Gross Motor Quotient Change Score 1 Year After Receiving Autologous UCB.|The Peabody Developmental Motor Scales - Second Edition (PDMS-2), Gross Motor Quotient change score was calculated for each patient at 1 year after infusion with autologous umbilical cord blood. Analyzed by infused dose, above or below the median. The Gross Motor Quotient score from the PDMS-2 was used in this study to evaluate gross motor function. The Gross Motor Quotient measures the ability to use large muscle systems for locomotion, maintain a stable posture when not moving, and throw/catch objects. The range of possible scores is 41 to 164. High scores indicate better gross motor function. Lower scores indicate less gross motor function ability.|1 year post-infusion with autologous umbilical cord blood|This group combines patients who received Autologous Umbilical Cord Blood at baseline or 1 year post-infusion with Placebo, and who are within the age range specified for the PDMS-2. The threshold defining Low/High dose is the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.|||units on a scale||Full Range|Median
1414203|NCT01147653|Post-Hoc|Observed Minus Expected GMFM-66 Change Score of All Subjects Receiving Autologous UCB and Who Are Greater Than or Equal to 2 Years of Age|Validated functional curves were used to identify the expected 1-year change in GMFM-66 score given each child's age and Gross Motor Function Classification System (GMFCS) Level at baseline. The difference between observed change (in this study) and expected change was then calculated for each participant. The threshold defining Low/High dose is the median dose infused in all 63 enrolled patients, 2x10e7 TNCC/kg.|1 year post-infusion with autologous umbilical cord blood|Patients who received cord blood at baseline and 1 year post-infusion with Placebo, and who are >=2 years old (to allow calculation of expected GMFM-66 change scores from published data). An additional 6 are excluded because change scores were not observable due to subject withdrawal (5) or inability to comply due to a broken leg (1).|||units on a scale||Full Range|Median
1414204|NCT01147653|Post-Hoc|Gross Motor Function Measure 66 (GMFM-66) Change Score at 1 Year by Infused Dose|Gross Motor Function Measure 66 (GMFM-66) Change Score at 1 Year. Analyzed by infused dose, above or below the median. The GMFM-66 is a clinical tool used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator (GMAE) that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. A negative change in GMFM-66 score indicates a reduction in motor function, a positive change indicates improvement in motor function, and zero indicates no change in motor function.|1 Year|Patients randomized to Autologous Umbilical Cord Blood were divided into two groups for this analysis: Low and High dose. The median dose infused in these 32 patients was used as the cut point to define Low and High doses: 1.98x10e7 total nucleated cells per kilogram of patient weight (TNCC/kg).|||units on a scale||Full Range|Median
1414205|NCT01147653|Other Pre-specified|Change in Barry-Albright Dystonia Total Score From Baseline to Year 1|The Barry-Albright Dystonia Scale measures generalized dystonia in eight body regions (eyes, mouth, neck, trunk, and the four extremities) using an ordinal scale (0=no dystonia, 1=slight dystonia, 2=mild dystonia, 3=moderate dystonia, and 4=severe dystonia). Individual scores for each region are summed to obtain a total score. The total score can range from 0 to 32 and higher scores indicate an overall greater degree of dystonia. The change in Barry-Albright Dystonia Total Score was evaluated from Baseline to Year 1. Positive numbers indicate increasing dystonia, negative numbers indicate a decrease in dystonia, and zero indicates no change.|Baseline to Year 1||||units on a scale||Full Range|Median
1414206|NCT01147653|Secondary|Parent Experience of Child Illness|This outcome measure was not used in this study because it had not been validated for children with Cerebral Palsy.|Baseline to Year 1|||||||
1414207|NCT01147653|Secondary|Change in Bruininks-Oseretsky-2 Total Motor Composite From Baseline to Year 1|The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, (BOT-2) evaluates motor function in four areas: stability, mobility, strength, coordination, and object manipulation. A Total Motor Composite is then calculated and expressed on a normal distribution with mean 50 and standard deviation of 10. Higher scores indicate better motor function. The BOT-2 Total Motor Composite was used to measure motor function in children at age 6 in this study. The study intended to evaluate change in the BOT-2 Total Motor Composite from Baseline to Year 1, where positive change indicates improvement in motor function, negative change indicates decrease in motor function, and zero indicates no change.|Baseline to Year 1|The BOT-2 Total Motor Composite was available at Baseline and Year 1 in only 1 subject. The change score for that subject is reported here.|||units on a scale|||Number
1414208|NCT01147653|Secondary|Modified Ashworth Scale at Year 1|The Modified Ashworth Scale uses a 6 point scale (range 0, 1, 1+, 2, 3, or 4) to measure spasticity in 5 body regions (central, right upper extremity, left upper extremity, right lower extremity, and left lower extremity). Scores of 0 indicate no increase in muscle tone whereas a score of 4 indicates rigidity in flexion or extension.|Year 1|Patients are classified by their maximum score, regardless of body region.|||Participants|||Count of Participants
1414210|NCT01147653|Secondary|Change in Difficult Child Score From Baseline to Year 1|Parent stress was evaluated with the Parenting Stress Index - Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range. Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change.|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.|||units on a scale||Standard Error|Mean
1414211|NCT01147653|Secondary|Change in Parent-Child Dysfunctional Interaction From Baseline to Year 1|Parent stress was evaluated with the Parenting Stress Index - Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range. Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change.|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.|||units on a scale||Full Range|Median
1414212|NCT01147653|Secondary|Change in Parental Distress From Baseline to Year 1|"Parent stress was evaluated with the Parenting Stress Index – Short Form for children aged 0-12 years, which measures stress in three domains: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Results in each domain are expressed as percentiles. Scores from the 15th-80th percentile are considered to be within the normal range.~Scores at or above the 85th percentile considered high distress. Scores greater than the 89th percentile indicate clinically significant levels of distress. Analysis focused on changes in percentile scores between Baseline and Year 1. Positive numbers represent an increase in distress, negative numbers represent a decrease in distress, and zero indicates no change."|Baseline to Year 1|No participants were outside the age range for this test but change scores could not be calculated for some participants due either to missing data at the Baseline or Year 1 visit.|||Change in percentile score||Standard Error|Mean
1414213|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Total Problems From Baseline to Year 1|Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change.|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.|||units on a scale||Full Range|Median
1414214|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Externalizing Problems From Baseline to Year 1|Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change.|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.|||units on a scale||Standard Error|Mean
1414215|NCT01147653|Secondary|Change in Child Behavior Checklist (CBCL) Z-score Internalizing Problems From Baseline to Year 1|Two versions of the CBCL exist for children ages 1.5 to 5 years and ages 6-18 years. The CBCL evaluates internalizing and externalizing behaviors and total problems using 99-item assessments that are scored on an ordinal scale as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child” based on behavior in the preceding two months. Scores are expressed on a standard normal distribution with mean 50 and standard deviation 10. Z scores were created for analysis. A Z-score represents the distance from the population mean in terms of the number of standard deviations. The change in Z-score from Baseline to Year 1 was calculated for each patient. A positive number indicates an increase in the behavior, a negative number indicates a decrease in the behavior, and a zero indicates no change.|Baseline to Year 1|Evaluations done outside the age ranges specified for the assessments were excluded, the majority being assessments that were done on patients who were not yet 1.5 years of age.|||units on a scale||Full Range|Median
1414216|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Social Function Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Social Function score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.|||units on a scale||Standard Error|Mean
1423350|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Leucocytes|Change from baseline|Baseline and 52 week after||||/microliter(mcl)||Standard Deviation|Mean
1414218|NCT01147653|Secondary|Change in Pediatric Evaluation of Disability (PEDI) Self Care Score|The Pediatric Evaluation of Disability is used to evaluate functional skills in children aged 6 months to 7 years in three areas: Self Care, Mobility, and Social Function. The score in each area can range from 10-90. Higher scores indicate higher function. The change from Baseline to Year 1 in the Self Care score is presented here. Positive scores indicate increased function, negative scores indicate a decrease, and zero indicates no change.|Baseline to Year 1|Patients were excluded if change scores were not observable due to missing data at Baseline or Year 1.|||units on a scale||Standard Error|Mean
1414219|NCT01147653|Secondary|Change in Assisting Hand Assessment (AHA) Score From Baseline to Year 1|The Assisting Hand Assessment (AHA) measures the use of hemiplegic cerebral palsy patients' involved hand in tasks involving two hands. The test is valid for ages 18 months to 12 years. The score is an interval scale ranging from 22 to 88 with higher numbers indicating more effective use of the affected hand in performance of bimanual tasks. Change in this score was evaluate between Baseline and Year 1. Positive numbers indicate more effective use of the affected hand, negative numbers indicate a reduction in the effective use of the affected hand, and a zero indicates no change.|Baseline to Year 1|Participants who were less than 18 months old, or had diplegia or quadriplegia were excluded. For those with unspecified typography, AHA scores were excluded if scores on either the Modified Ashworth Scale or Barry-Albright Dystonia scale indicated neither or both of the upper extremities were involved.|||units on a scale||Standard Error|Mean
1414220|NCT01147653|Secondary|Change in Cognitive Z-Score From Baseline to Year 1|Because patients in this study were evaluated with different cognitive assessments based on their age at the time of assessment (The Bayley-III Cognitive Composite, the WPSSI-III Full Scale IQ, and the WISC-IV Full Scale IQ Composite), with some patients being assessed using different tools at subsequent visits during the trial, a method for combining the assessments was employed to evaluate change in cognitive function over time in as many patients as possible. A cognitive Z-score was calculated for each participant at Baseline and Year 1 by adjusting each score by the relevant assessments’ population mean and standard deviation. The Z-scores represent the distance from the population mean, as measured by standard deviations. The analysis presented here summarizes the change in Z-score between Baseline and Year 1. A positive number indicates an increase in cognitive function, a negative number indicates a decrease, and zero indicates no change.|Baseline to Year 1|When using all available cognitive assessments, the change in cognitive Z-score was available for 42 of the 63 participants.|||Z scores||Standard Error|Mean
1414221|NCT01147653|Secondary|Change in the Wechsler Intelligence Scale for Children (WISC-IV) From Baseline to Year 1.|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. The WISC-IV is designed for children 6 years 0 months to 16 years 11 months. This study used the Full Scale IQ, which ranges from 45 to 155 with a mean of 100 and standard deviation of 15. Higher scores indicate stronger cognitive function. Scores between 90 and 110 are considered to be within the range of average IQ.|Baseline to Year 1|Only one patient in this trial was evaluated with the WISC-IV and thus change over time could not be evaluated using this outcome measure. The single value for this patient is reported here.|||Full Scale IQ Points|||Number
1414222|NCT01147653|Secondary|Change in Wechsler Preschool and Primary Scale of Intelligence (WPPSI) III Full Scale Intelligence Quotient (IQ) for Younger Children (Ages 2 Years & 6 Months to 3 Years & 11 Months) From Baseline to Year 1.|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. There are two versions of the WPPSI-III for two different age ranges: 2 years & 6 months to 3 years & 11 months, and 4 years to 7 years & 3 months. The Full Scale IQ is calculated for both age ranges and provides a continuous score with an average of 100 and a standard deviation of 15. Change from Baseline to Year 1 was evaluated, with positive numbers indicating an increase in cognitive ability, negative numbers indicating a decrease in cognitive ability, and zero indicating no change.|Baseline to Year 1|Change scores were evaluable in only 2 subjects who were assessed with the WPPSI-III at both Baseline and Year 1. One subject was randomized to Autologous Cord Blood and the other to Placebo.|||units on a scale|||Number
1414223|NCT01147653|Secondary|Change in Bayley Scales of Infant and Toddler Development-III, Cognitive Composite From Baseline to Year 1|Cognitive function was assessed in English-speaking study participants using one of three different tools depending on the age of the patient at the time of assessment: The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Wechsler Intelligence Scale for Children (WISC-IV), and the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III). Some patients were assessed with different tools at subsequent visits as they aged during the conduct of the trial. The Bayley-III is designed to assess developmental functioning of infants and toddlers. Scores for the Cognitive Composite range from 1 to 19 and results in the range of 8 to 12 are considered average. The outcome measure reported here is the change in Cognitive Composite between Baseline to Year 1. Positive numbers indicate increases in cognitive functioning, negative numbers indicate a decrease, and zero indicates no change.|Baseline to Year 1|The Bayley III is an age-specific test and was used for 42 patients at Baseline. A total of 27 of these patients were also scored with the Bayley III at Year 1. The results here represent change from Baseline to Year 1 in the 27 participants assessed with the Bayley III at both time points.|||units on a scale||Standard Error|Mean
1414224|NCT01147653|Secondary|Correlation Between Clinical Response and RNA Expression of Neural, Endothelial and Inflammatory Cytokines Measured by RNA Arrays in Cord Blood Cells Given to These Patients.|Various pre-selected neural, angiogenic, and anti-inflammatory markers expressed by UCB cells and clinical response will be evaluated.|2 years||2022-01-31|01/2022||||
1414225|NCT01147653|Secondary|Change in Loes Score of Functional MRI From Baseline to Year 1 and From Year 1 to Year 2|No data were collected from this procedure because enrolled subjects who were eligible to receive fMRI were unable to comply with the procedure.|Baseline, Year 1, Year 2|No data was available.||||||
1414226|NCT01147653|Secondary|Change in Whole Brain Connectivity Measured by Diffusion Tensor Magnetic Resonance Imaging (MRI)|Change in number of connections in the brain as measured by diffusion tensor magnetic resonance imaging (MRI). Changes in connectivity are normalized to white matter volume of the brain. A positive number indicates an increase in connections, a negative number indicates a decrease, and zero indicates no change. The number of connections is expressed in terms of 10e5. For example, a change of 1 indicates an increase of 1x10e5 or 100,000 connections.|Baseline to Year 1|Patients without substantial morphologic brain abnormalities that prevented accurate anatomical image parcellation.|||Number of connections x10e5||Full Range|Median
1414227|NCT01147653|Secondary|Change in CP-QOL Score|Children age four years or older at study entry were assessed using the disease-specific “CP-QOL Child” assessment tool as completed by a parent. The CP-QOL Child primary-caregiver proxy form is designed for children 4 – 12 with cerebral palsy and contains 66 items which assess physical, emotional, and social well being as well as access to services and acceptance by others. Scores are summarized in seven topic areas. Scores in each area range from 0 (worst health) to 100 (best health). The change score from Baseline to Year 1 is summarized here for each item. Negative scores indicated a decrease in quality of life, positive scores indicate an increase and zero indicates no change.|Baseline, Year 1|The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points.|||units on a scale||Full Range|Median
1414228|NCT01147653|Secondary|Change in IT-QOL Questionnaire Score|The Infant and Toddler Quality of Life Questionnaire (IT-QOL) was utilized for children ages one to three years at study entry.This 97-item questionnaire is completed by the parents and covers 12 concepts related to the physical, mental, and social well being of the child and the impact of their illness on the family. Scores range from 0 (worst health) to 100 (best health). The change from Baseline to Year 1 is summarized here for each of the 12 items on the questionnaire. Negative values indicate a decline in quality of life over time, positive values indicate an improvement, and zero indicates no change.|Baseline to Year 1|The analysis includes patients whose parents reported scores on each item at both Baseline and Year 1 and whose children met the age criteria for the questionnaire at both time points.|||units on a scale||Full Range|Median
1414229|NCT01147653|Secondary|Change in Peabody Gross Motor Quotient From Baseline to Year 1|The Peabody Developmental Motor Scales - Second Edition (PDMS-2) measures gross and fine motor skills in children from birth through five years of age. The Gross Motor Quotient score from the PDMS-2 was used in this study to evaluate gross motor function. The Gross Motor Quotient measures the ability to use large muscle systems for locomotion, maintain a stable posture when not moving, and throw/catch objects. The range of possible scores is 41 to 164. High scores indicate better gross motor function. Lower scores indicate less gross motor function ability. The change in Gross Motor Quotient from Baseline to Year 1 was evaluated in this study. Positive numbers indicate an increase in gross motor ability, negative numbers indicate decreases in gross motor function, and a zero indicates no change.|Baseline to Year 1|Participants outside of the applicable age range for the PDMS-2 at Baseline or Year 1 were excluded from the analysis.|||units on a scale||Full Range|Median
1414230|NCT01147653|Primary|Change in Gross Motor Function Measure 66 (GMFM-66) Score|Change in Gross Motor Function Measure 66 (GMFM-66) Score from Baseline to Year 1. The GMFM-66 is a clinical tool used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator (GMAE) that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. A negative change in GMFM-66 score indicates a reduction in motor function, a positive change indicates improvement in motor function, and zero indicates no change in motor function.|Baseline to Year 1|All enrolled patients were analyzed as randomized from Baseline to Year 1.|||units on a scale||Standard Deviation|Mean
1414231|NCT01147640|Secondary|Microbiological Response of CXA 101/Tazobactam and Metronidazole at the TOC Visit in the Microbiologically Evaluable (ME) Population|Microbiological response is eradication (absence of the baseline pathogen from a suitable intra-abdominal specimen) or presumed eradication (absence of a suitable intra-abdominal specimen to culture at the TOC visit in a subject who is assessed as a clinical cure at TOC)|Test-of-Cure Visit (7-14 days after EOT)|Microbiologically Evaluable: treated subjects, with baseline pathogen susceptible to study drug, complied with protocol|||percentage of subjects||95% Confidence Interval|Number
1414232|NCT01147640|Primary|Clinical Response of CXA 101/Tazobactam and Metronidazole at Test of Cure (TOC) Visit in the Microbiological Modified Intent to Treat (mMITT) Analysis Population|Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|Test-of-Cure Visit (7-14 days after End of Therapy [EOT])|mMITT: Treated subjects, with baseline pathogen|||percentage of subjects||95% Confidence Interval|Number
1414233|NCT01147627|Secondary|Safety and Tolerability in Different Groups||48 weeks|||||||
1414234|NCT01147627|Secondary|β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)||48 weeks|||||||
1414235|NCT01147627|Secondary|Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles||48 weeks|||||||
1414236|NCT01147627|Primary|the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks||48 weeks||||percentage of HbA1c||Standard Deviation|Mean
1414237|NCT01147601|Secondary|Compare Treatment Group to Control Group Improvement Assessments|"The proportion of subjects in the treatment group as compared to the placebo control group with at least 50% improvement in the extent of the hemangioma.~The difference between the extent/size of the hemangioma as an outcome measure versus color changes.~Frequency of adverse events (e.g. hypotension, behavioral changes, etc.), collected by the investigator and reported by the parents."|at 6 months|||||||
1414238|NCT01147601|Primary|Proportion of Subjects in Treatment Group Compared to Placebo Group With at Least 75% Improvement in the Extent of the Hemangioma as Compared to Baseline Photos.|This will be generated by asking each of the assessors to score the improvement using a visual analog scale (VAS) assessing the decrease in size of hemangioma by comparing photographs at different times of treatment. The assessors will score this improvement into one of the following categories: 0-24%, 25-49%, 50-74%, >75%.|at 6 months||||Participants|||Count of Participants
1414241|NCT01147497|Secondary|Acceptability of Discomfort Associated With Insertion||assessed at one week after insertion and at one month after insertion|Data were not collected for this outcome measure. The follow-up participant questionnaires developed for this study were piloted prior to study initiation and this question was removed for clarity, to focus on the primary study aims, and to reduce participant burden.||||||
1414242|NCT01147497|Secondary|Time for Insertion Procedure||assessed immediately after IUD insertion|Data were not collected for this outcome measure. The provider questionnaire developed for this study was piloted prior to study initiation and this question was removed for clarity and to focus on the primary study aims.||||||
1414243|NCT01147497|Secondary|The Use of Adjunctive Measures Including Ultrasound Guidance or Cervical Dilation to Insert the IUD||assessed immediately after IUD insertion||||participants|||Number
1414244|NCT01147497|Secondary|Patient Perceived Pain on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived patient pain ranges from 0 (no pain) to 100 (most pain).|immediately after insertion||||units on a scale||Full Range|Median
1414245|NCT01147497|Primary|Provider Perceived Ease of Insertion on a 100 Point Visual Analogue Scale|The visual analogue scale for perceived ease ranges from 0 (most ease) to 100 (most difficult).|assessed immediately post IUD insertion||||units on a scale||Full Range|Median
1414246|NCT01147471|Other Pre-specified|Still on Narcotics at Post-discharge Follow-up|Number of people still on narcotics at time of routine care post-discharge follow-up|approx 2 weeks post discharge||||participants|||Number
1414247|NCT01147471|Secondary|Pulmonary Function|Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits||||||
1414248|NCT01147471|Secondary|Quality of Life|Rand 36 health survey.|Measured at 3 and 6 months post-discharge|Data not collected - insufficient participants completed follow up visits||||||
1414249|NCT01147471|Primary|Mortality|Number of participants who died during any hospital stay.|Measured any time during hospital stay (approx 30 days)||||participants|||Number
1414250|NCT01147471|Primary|Morbidity|total days on ventilator, ICU length of stay, hospital length of stay|Measured daily during hospitalization (approx 1 month)|analysis is the mean and standard deviation for # days spent on each item measured|||days||Standard Deviation|Mean
1414251|NCT01147458|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 is a terminal metabolic product of arachidonic acid by 5-LO. Its synthesis is dependent upon the activity of 5-LO and it is eliminated through urinary clearance. Hence, the level of urinary LTE4 (uLTE4) excretion may be an indicator of endogenous 5-LO activity.|Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)|Since the study was terminated prematurely for a potential safety signal, and in light of the efficacy analysis, the pharmacodynamic (PD) assessment of uLTE4 was not performed and no data are reportable.||||||
1414252|NCT01147458|Secondary|Plasma Concentration of PF-04191834||Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43|Due to early termination of the study, only a subset of pharmacokinetic (PK) samples, from 10 out of 190 randomized participants, were selected for analysis. These 10 participants were selected based on treatment and treatment sequence.|||ng/mL||Standard Deviation|Mean
1414253|NCT01147458|Secondary|Rescue Medication Use|Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week.|Day -7 (Visit 2) up to 28-day follow-up (Visit 10)|Number of subjects analyzed (N) is the number of participants taking rescue mediation.|||Number of pills||Standard Deviation|Mean
1414254|NCT01147458|Secondary|Daily Diary Pain Score During Week 2 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414255|NCT01147458|Secondary|Daily Diary Pain Score During Week 1 of Each Treatment Period|The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).|4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414256|NCT01147458|Secondary|Importance Weighted Total WOMAC Score|Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414257|NCT01147458|Secondary|WOMAC Total Score|The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414541|NCT01144052|Primary|Number of Days Until First On-study Relapse|Patients were followed-up during 12 months and time to first on-study relapse from randomization was recorded.|12 months|All enrolled and randomized patients fulfilled the criteria for analysis.|||days||Full Range|Median
1414258|NCT01147458|Secondary|WOMAC Physical Function Domain Score|The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414259|NCT01147458|Secondary|WOMAC Stiffness Domain Score|The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness.|Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414260|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414261|NCT01147458|Primary|Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1|The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.|Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)|Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.|||Units on a scale||Standard Deviation|Mean
1414262|NCT01147406|Secondary|Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration|Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).|24 hours|Any subject that received the active IMP or placebo|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1414263|NCT01147406|Primary|Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers|Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.|7 Days|Any subject that received active IMP or placebo|||Adverse Events|||Number
1414264|NCT01147393|Primary|The Primary Objective of the Phase II Portion of the Study is to Determine the Anti-tumor Efficacy, as Measured by Response Rate, of Fractionated 90Y-epratutumab IgG Given in Combination With Veltuzumab Anti-CD20 IgG Therapy|||Data were not collected||||||
1414265|NCT01147393|Primary|Safety|||Data was not evaluated||||||
1414266|NCT01147393|Primary|Dose-limiting Toxicity|"NCI CTC version 3.0 is used to grade all adverse events and to provide management guidelines for infusional toxicity. Dose-limiting toxicity (DLT) is defined as follows:~Hematologic: Grade 4 toxicity >7 days, as specified by hemoglobin levels, platelet counts or absolute neutrophil count (ANC) or failure of hemoglobin levels, platelet counts or ANC to recover to Grade 1 levels within 12 weeks of completing the treatment cycle (with the use of RBC and platelet transfusions or growth factors during the 12 weeks if necessary, but at least one week without any support prior to qualifying Grade 1 levels).~Non-Hematologic: Any Grade 3 or Grade 4. Other: Any Grade 2 autoimmune reactions, or the occurrence of Grade 2 immediate-type allergic/hypersensitivity reactions (e.g., urticaria, wheezing, hypoxia and dyspnea) will be considered DLT and will also require the infusion to be permanently terminated.~Occurrence of DLT requires a patient’s treatment to be permanently discontinued"||Data were not collected||||||
1414267|NCT01147393|Primary|Determine the Maximum Tolerated 90Y Dose|||Data was not collected||||||
1414268|NCT01147380|Secondary|Anti-HCV Effect of This Treatment (If Applicable)||2 year|||||||
1414269|NCT01147380|Secondary|Anti-HCC Effect of This Treatment||2 year|||||||
1414270|NCT01147380|Secondary|NK Cell Infusion-related Toxicity|To assess NK cell infusion -related toxicity at the bedside. We will monitor the patient and check the vital sign. If any side effect are noticed, we will record and report to the data safety monitoring comittee.|1 year|Participants were devided two group( small and large dose) as described based on the dose of infused cell numbers.|||participants|||Number
1414271|NCT01147380|Primary|Side Effect of Cadaveric Donor Liver NK Cell Infusion|Side effect of cadaveric donor liver NK cell infusion We will measure the occurence of the side effect of the liver NK cell infusion. We will monitor the patient condition clinically. If any side effect are noticed, we will record them and report to the data safety monitoring comittee.|1 year||||participants|||Number
1414293|NCT01147302|Secondary|Change From Baseline in Creatinine Clearance|Graft function was assessed by measuring creatinine clearance. Creatinine clearance was calculated by the Cockcroft-Gault formula. Baseline was the last value collected prior to first dose of study drug. A positive change from baseline indicates that the clearance rate has increased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||mL/min||Standard Deviation|Mean
1423351|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and 52 week after||||g/dL||Standard Deviation|Mean
1414272|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
1414273|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.~The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
1414274|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.~Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
1414275|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
1414276|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
1414277|NCT01147341|Other Pre-specified|Proportion of Subjects Achieving a CDAI Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 24|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to Week 24|30 subjects were included in the efficacy assessment as week 24. Subjects completed 24 weeks dosing including a 12 week open-label phase.|||participants|||Number
1414294|NCT01147302|Secondary|Change From Baseline in Serum Creatinine|Graft function was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Baseline was the last value collected prior to first dose of study drug. A negative change from baseline indicates that serum creatinine levels have decreased. Values for Day 90 were collected +/= 14 days.|From Day 1 to Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||mg/dL||Standard Deviation|Mean
1414278|NCT01147341|Secondary|Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement..|Baseline to week 12||||participants|||Number
1414279|NCT01147341|Secondary|Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"The EULAR (European League Against Rheumatism) response criteria is a classified response criteria which classifies the patients individual as non-, moderate or good responders dependent on the change and the level of the Disease Activity Score.~The Disease Activity Score(DAS28) is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from baseline), or no response (absolute: >5.1 or <0.6 change from baseline)."|Baseline to week 12||||participants|||Number
1414280|NCT01147341|Primary|Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group|"ACR20 responders are subjects with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale(VAS).~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|From Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing. 30 subjects who completed the 24 week study were included in the efficacy assessment at week 24.|||participants|||Number
1414281|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP)|"The Disease Activity Score-28-C-reactive Protein (DAS28-CRP)is a composite measure for rheumatoid arthritis (RA) is based on 4 variables: tender and swollen joint counts (28 joints),C-Reactive Protein(CRP), and patient global assessment visual analog scale. A lower score indicated less disease activity.~Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22"|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing.|||participants|||Number
1414282|NCT01147341|Secondary|Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|"ACR50 responders are subjects with at least 50% improvement from baseline for tender joint cout (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale.~HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.~Visual Analog Scale (VAS) - assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad."|Baseline to Week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing|||participants|||Number
1414283|NCT01147341|Primary|Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12|The Clinical Disease Activity (CDAI)is a composite score. Clinical Disease Activity (CDAI) = SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs (including thumb IP)+ PGA: Patient Global disease Activity (patient’s self assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity)+ EGA: Evaluator’s Global disease Activity (evaluator’s assessment of overall RA disease activity on a scale 0-10 where 10 is maximal activity) Remission: CDAI ≤ 2.8; Low Disease Activity: CDAI > 2.8 and ≤ 10 ;Moderate Disease Activity: CDAI > 10 and ≤ 22; High Disease Activity: CDAI > 22. A CDAI reduction of 6.5 represents moderate improvement.|Baseline to week 12|35 subjects were included in the efficacy assessment at week 12. Subjects in the efficacy assessment at week 12 completed at least 4 weeks of dosing|||participants|||Number
1414292|NCT01147302|Secondary|Number of Plasmapheresis Sessions|If necessary, rescue therapy included plasmapheresis. Participating centers used plasmapheresis for desensitization, if necessary, prior to transplant and also for the treatment of acute AMR. Plasmapheresis therapy was performed for the qualifying episode of AMR according to standards at the investigational site and at the discretion of the investigator. Sessions include those prior to first dose. If plasmapheresis therapy occurred on the same day as study drug dosing, study drug was administered after completion of the plasmapheresis session.|From Day 1 through Days 20 and 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||sessions||Standard Deviation|Mean
1414284|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||Units*h/mL||Standard Deviation|Mean
1414285|NCT01147302|Secondary|Area Under The Concentration-Time Curve (AUC) of C1 INH Antigen|Plasma samples were used for the determination of antigenic C1 INH parameters. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), and area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||g*h/L||Standard Deviation|Mean
1414286|NCT01147302|Secondary|Time to Maximum Plasma Concentration (Tmax) of C1 INH|Plasma samples were used for the determination of antigenic and functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||hours||Full Range|Median
1414287|NCT01147302|Secondary|Serum Concentrations of C1 INH Functional Activity|Plasma samples were used for the determination of functional C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||Units/mL||Standard Deviation|Mean
1414288|NCT01147302|Secondary|Serum Concentrations of C1 Inhibitor (C1 INH) Antigen|Plasma samples were used for the determination of antigenic C1 INH concentrations. Primary pharmacokinetic (PK) parameters were calculated using baseline-corrected concentration-versus-time data following the last dose and noncompartmental techniques, as appropriate. The following PK parameters were calculated: baseline concentration (Cbaseline), maximum concentration (Cmax), average concentration at steady-state (Cav,ss), time to maximum concentration (tmax), minimum concentration (Cmin), area under the concentration-time curve from time zero to last quantifiable concentration at time t (AUC0-t). Blood was collected on Day 13 at the indicated timepoints. If plasmapheresis was performed on a dosing day, blood samples were obtained before plasmapheresis, prior to study drug administration (post-plasmapheresis), and at time points relative to the start of infusion.|Day 13 pre-plasmapheresis (if performed) and pre-dose then 0.5, 2, 24, 48, 96, 168 and 288 (optional) hours post start of infusion||||g/L||Standard Deviation|Mean
1414289|NCT01147302|Secondary|Number of Participants With Allograft Failure|Allograft failure was determined by the presence of the following criteria: current renal allograft nephrectomy and/or a clinical determination that the allograft irreversibly and irrevocably ceased functioning.|From the day of enrollment to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
1414290|NCT01147302|Secondary|Number of Deaths||From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
1414291|NCT01147302|Secondary|Number of Participants Who Required Salvage Splenectomy|If necessary, rescue therapy included splenectomy.|From Day 1 to Day 90|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
1414374|NCT01146054|Primary|To Determine the Rate of (Grade 2 or Greater) Gastrointestinal Toxicity Attributable to Gemcitabine and Fractionated SBRT at One Year.|Grade 2 or greater late gastritis, fistula, enteritis, or ulcer or late grade 3-4 gastrointestinal toxicity at one year.|One year.|The whole cohort was analyzed.|||Number of toxicities.|||Number
1414295|NCT01147302|Primary|Change From Baseline in Histopathology Endpoints|The protocol-specified Day 20 (post-treatment) biopsy was compared to the qualifying biopsy to assess changes in histopathology for light and immunofluorescence microscopy. The Central Pathologist provided the following categorical information from the qualifying biopsy in an AMR Scorecard: C4d Score (0-100), Margination Score (0-100) Glomerulitis Score (0-100), Vasculitis Score (0-100), Glomerulosclerosis Score (0-100), Chronic Glomerulopathy Score (0-100), Interstitial Fibrosis Score (0-100), and the Chronic Vasculitis Score (0-100), with 0 being absence of abnormal histopathology. The “qualifying” renal allograft biopsy was performed as standard of care (SOC) within 12 months after transplant and prior to screening for this study. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy. A negative change from baseline indicates that histopathology has improved. Endpoint includes subjects with both Qualifying and Day 20 Biopsies.|Within 72 hours prior to first dose of study drug, Day 20|The ITT-S population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||scores on a scale||Standard Deviation|Mean
1414296|NCT01147302|Secondary|Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR)|The “qualifying” renal allograft biopsy was performed as standard of care within 12 months after transplant and prior to screening. The qualifying biopsy was used to establish the diagnosis of AMR and was evaluated for all of the following to obtain baseline assessments: the presence of C4d, and monocyte or neutrophil infiltration around the peritubular capillaries (PTCs) and/or glomeruli. The Central Pathologist provided the following information from the qualifying biopsy in an AMR Scorecard: C4d Score, Glomerulitis Score, Vasculitis Score, Glomerulosclerosis Score, Chronic Glomerulopathy Score, Interstitial Fibrosis Score, and the Chronic Vasculitis Score. The Banff AMR Scoring System was used to summarize these scores. Resolution determination was made based on clinical criteria (improvement of serum creatinine ± decrease of DSA titer, and/or increase in urine output) and histopathology. The first dose of study drug (Day 1) was administered within 72 hours after qualifying biopsy.|90 days after start of treatment|The Intent-to-Treat Safety (ITT-S) population, defined as participants who received at least 1 dose (or any portion of a dose) of study drug (CINRYZE or placebo).|||participants|||Number
1414297|NCT01147250|Secondary|Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108|Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.|Baseline to Week 108 (LOCF)|ITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline UACR value. Missing data was imputed using last observation carried forward (LOCF) using the last available post-baseline UACR before Week 108 as the value at Week 108, regardless of treatment discontinuation or not.|||percent change||Standard Error|Geometric Mean
1414298|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure|All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.|||participants|||Number
1414299|NCT01147250|Secondary|Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure|All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.|From randomization up to the end of study (median follow-up of 25 months)|ITT population.|||participants|||Number
1414300|NCT01147250|Primary|Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.|From randomization up to the end of study (median follow-up of 25 months)|Intent-to-treat (ITT) population defined as all randomized participants analyzed according to the treatment group allocated at randomization.|||participants|||Number
1414301|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of subjects with pigmentation changes at site of injection at End of Study|24 Weeks|Safety Population|||Percentage (%) of subjects|||Number
1414302|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|12 Weeks|Safety Population|||Percentage (%) of subjects|||Number
1414303|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|6 Weeks|Safety Population|||Percentage (%) of subjects|||Number
1414304|NCT01147172|Primary|Pigmentation Changes at Site of Injection|Percentage of Subjects with pigmentation changes at site of injection|2 Weeks|Safety Population|||Percentage (%) of subjects|||Number
1414305|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of subjects with keloid formation at the site of injection at End of Study|24 Weeks|Safety Population|||Percentage (%) of subjects|||Number
1414306|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|12 Weeks|Safety Population|||Percentage (%) of subjects|||Number
1414307|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|6 Weeks|Safety Population|||Percentage (%) of subjects|||Number
1414308|NCT01147172|Primary|Keloid Formation at Site of Injection|Percentage of Subjects with keloid formation at the site of injection|2 Weeks|Safety Population|||percentage of participants|||Number
1414375|NCT01145898|Primary|3-year Change in OPP|Measurement of change in ocular perfusion pressure|Baseline and 36 month visits||||mm Hg||Standard Error|Mean
1414376|NCT01145898|Primary|3-year Change in CRA RI|Measurement of change in ocular blood flow - central retinal arteries resistance index|Baseline and 36 month visits||||unitless||Standard Error|Mean
1414309|NCT01147068|Secondary|Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age|Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults|21 Days|All randomized subjects with Day 0 and Day 21 data analyzed by Cincinnati Children's Hospital Medical Center using the intent to treat population and CBER antigen.|||percentage of participants||95% Confidence Interval|Number
1414310|NCT01147068|Secondary|Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.|Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.|Day 0, and Day 42|All randomized subjects who received study vaccine and had Day 0 and Day 42 geometric mean titers. Analysis of results were generated by Southern Research Institute on the overall population using whole virus.|||titer||95% Confidence Interval|Geometric Mean
1414311|NCT01147068|Primary|Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.|42 Days|All randomized subjects who received study vaccine and had Day 0 and Day 42 efficacy data. The analysis results are generated by Southern Research Institute on the intention to treat efficacy population using whole virus.|||percentage of participants||95% Confidence Interval|Number
1414312|NCT01147055|Secondary|Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)|Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1414313|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC (0 - ∞)]|Molar ratio of metabolite to parent area under the curve from time zero to extrapolated infinite time [MRAUC (0-∞)].|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose) , 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1414314|NCT01147055|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (MRAUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Ratio||Standard Deviation|Geometric Mean
1414315|NCT01147055|Secondary|Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1414316|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1414317|NCT01147055|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of crizotinib metabolite (PF-06260182). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1414318|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of crizotinib metabolite (PF-06260182).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1414345|NCT01146860|Secondary|SNOT 20 Symptom Scores|"Sino-Nasal Outcome Test (SNOT 20): 20 item questionnaire to assess the symptoms and emotional and social consequences of rhinosinusitis. The symptoms are assessed by the patient using a 6-point rating scale: 0 = not present / no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be.~range: 0 to 100"|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||units on a scale (range: 0 - 100)||Standard Deviation|Mean
1414319|NCT01147055|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
1414320|NCT01147055|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose CL/F is influenced by the fraction of the dose absorbed.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1414321|NCT01147055|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1414322|NCT01147055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1414323|NCT01147055|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1414324|NCT01147055|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1414325|NCT01147055|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2|The pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1414326|NCT01147042|Primary|Basal and PMA-stimulated O2 Production Detected by Ferricytochrome c Reduction in Neutrophils||21 weeks|Data were not collected.||||||
1414327|NCT01146951|Secondary|Clinical Global Impression of Change (CGIC)|"CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward [LOCF]) & at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation [d/c]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period).~The CGIC was assessed according to the following 7-grade scale based on the frequency & severity of seizures, AEs, and overall conditions of daily life.~Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened."|Up to Week 12 of the treatment period|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||participants|||Number
1414328|NCT01146951|Secondary|Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days)|"Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].~Seizures analyzed other than tonic-atonic seizures included:~Partial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, & Uncla. (unclassified) epileptic seizure.~The frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Percent change||Full Range|Median
1414329|NCT01146951|Secondary|Percent Change in Total Seizure Frequency (Per 28 Days)|Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Percent Change||Full Range|Median
1414330|NCT01146951|Secondary|Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency|50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency.|12 weeks|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Participants|||Number
1414331|NCT01146951|Primary|Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)|"The sum of the frequencies of tonic seizures and atonic seizures was defined as the “tonic-atonic seizure frequency” and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline].~The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period."|Baseline (28 day observational period) and End of Treatment (28 day treatment period)|"Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below.~Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment."|||Percent Change||Full Range|Median
1414332|NCT01146912|Primary|Influenza Immunization: Delayed Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2012|March 31, 2012||||%participants vaccinated with influenza|||Number
1414333|NCT01146912|Primary|Influenza Immunization: Pregnant Women|percentage of pregnant participants with influenza immunization by December 31, 2011|by December 31, 2011||||%participants vaccinated with influenza|||Number
1414334|NCT01146912|Secondary|Attendance at Appointment|percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011|September-December 2011||||% participants attending appointment|||Number
1414335|NCT01146912|Secondary|Pediatric: Vaccinated at Influenza Clinic|percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011|March 31, 2011|those unvaccinated by the start date for their cohort|||% participant vaccinated at flu clinic|||Number
1414336|NCT01146912|Primary|Influenza Immunization: Pediatric|percentage of pediatric participants with influenza immunization by March 31 of 2011|March 31, 2011|Individuals unvaccinated by time intervention start for their cohort|||% participant vaccinated with influenza|||Number
1414337|NCT01146873|Secondary|Highest Grade ALT After Randomization|Highest grade ALT after randomization. Grading was determined based on the Division of AIDS (2004) Toxicity Tables to grade adverse reactions. Grading scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (potentially life-threatening).|through 48 weeks post randomization||||number of participants|||Number
1414338|NCT01146873|Secondary|Percentage of Participants With Elevated Total Cholesterol, Elevated LDL, Abnormal HDL, or Abnormal Triglycerides at 40 Weeks After Randomization|Percentage of participants with elevated total cholesterol, elevated LDL, abnormal HDL, or abnormal triglycerides at 40 weeks after randomization|40 weeks||||percentage of participants|||Number
1414339|NCT01146873|Secondary|CD4 Cell Percentage at 48 Weeks After Randomization|CD4 Cell Percentage at 48 Weeks After Randomization|48 weeks||||percentage of cells||95% Confidence Interval|Mean
1414340|NCT01146873|Primary|Viral Failure|Probability of viral failure defined as >= 2 HIV RNA measurements >1000 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks||||probability of viral failure||95% Confidence Interval|Mean
1414341|NCT01146873|Primary|Viral Rebound|Probability of viral rebound defined as >=1 HIV RNA measurements >50 copies/ml using survival analysis by 48 weeks post-randomization.|48 weeks||||probability of viral rebound||95% Confidence Interval|Mean
1414342|NCT01146860|Secondary|Ultrasonography of Paranasal Sinuses|Percentage of patients with signs of acute rhinosinusitis in ultrasonography of paranasal sinuses will be evaluated. Ultrasonography scans will be visually evaluated by the investigator for signs of rhinosinusitis.|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||percentage of patients|||Number
1414343|NCT01146860|Secondary|Percentage of Patients Classified as Responders by the Investigator on a 4-point Rating Scale|"General assessment of efficacy using a 4-point rating scale (symptoms healed, improved, unchanged, deteriorated). Patients whose symptoms are improved or healed will be classified as responders to treatment. Patients whose symptoms are unchanged or deteriorated as classified as non-responders."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||percentage of patients|||Number
1414344|NCT01146860|Secondary|Major Symptom Score Assessed by the Patient|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.~Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.~Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||units on a scale||Standard Error|Mean
1414346|NCT01146860|Primary|Major Symptom Score (MSS) Assessed by the Investigator|"MSS: sum of the 5 main rhinosinusitis symptoms which are: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.~Each symptom is individually evaluated using the following 4-point rating scale (scoring system): 0 = none/not present, 1 = mild, 2 = moderate, 3 = severe.~Thus the MSS ranges from a minimum of 0 to a maximum of 15 score points."|14 days|FAS: randomised patients with at least one documented application of the drug and post-baseline efficacy data|||units on a scale||Standard Error|Mean
1414347|NCT01146808|Secondary|Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal||Six months after hepatitis B vaccination (2 years post transplant)||||Participants|||Count of Participants
1414348|NCT01146808|Secondary|Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination||12-18 months post transplant||||Participants|||Count of Participants
1414349|NCT01146808|Primary|Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver|Determined by hepatitis B serologies and viral load.|Standard of care visits post-transplant for 2 years||||Participants|||Count of Participants
1414350|NCT01146782|Secondary|Percent Reduction in Oxygen Desaturation Index (ODI)|Comparing first treatment night to control/baseline night reported as percent change. Negative numbers represent a reduction/improvement in ODI, whereas positive numbers represent increases/no improvement in ODI.|First treatment night||||ODI reduction (% change)||Inter-Quartile Range|Median
1414351|NCT01146782|Secondary|Last Treatment Night Response (AHI Reduction)|Comparing AHI at the last treatment night to the control/baseline night is reported as the percent change in AHI. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. Negative numbers represent a decrease/improvement in AHI, whereas positive numbers represent an increase/no improvement in AHI.|At completion of 28 day home use.|All subjects in primary endpoint cohort with final evaluable treatment PSG.|||AHI reduction (% change)||Inter-Quartile Range|Median
1414352|NCT01146782|Secondary|Adverse Event Rate|Further categorized as serious and non-serious, device-related and non-device-related, unanticipated and anticipated, and based on level of severity. Adverse events will be evaluated during the trial at the following visits during 28-day take-home period: 7-day, 14-day, 21-day, 28-day follow-up, and any unscheduled visits.|4 weeks|The Safety Cohort consisted of all subjects who participated in at-home use of the device.|||subjects|||Number
1414353|NCT01146782|Primary|Clinical Success Defined as Apnea-hypopnea Index (AHI) Reduction of >50% and Treated AHI<20|Comparing first treatment night AHI to control/baseline night. AHI is calculated by dividing the number of apnea/hypopnea events by the number of hours of sleep. AHI values are typically characterized as 5-15/hr = mild OSA, 15-30/hr = moderate OSA, and >30/hr = severe OSA. For each subject, Clinical success was defined as apnea-hypopnea index (AHI) reduction of >50% and treated AHI<20. The number of subjects with clinical success was determined to calculate the primary endpoint as the ratio of the number of subjects with clinical success to the number of subjects.|first treatment night|All subjects in the primary endpoint cohort were analyzed.|||subjects with clinical success|||Number
1414354|NCT01146613|Primary|Weekly Percentage of Heavy Drinking Days|Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.|Weeks 2-13*||||percentage of heavy drinking days||Standard Error|Mean
1414355|NCT01146600|Secondary|PSQI|"Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
1414356|NCT01146600|Secondary|SF-36, Vitality Subscale|"The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
1414357|NCT01146600|Secondary|FOSQ|"Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
1414358|NCT01146600|Secondary|Epworth Sleepiness Scale|"Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).~ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness."|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||units on a scale||Standard Deviation|Mean
1414359|NCT01146600|Secondary|PVT Number of Lapses|Number of lapses (no response for > 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance.|baseline, then after 1 week and 2 weeks on each study drug|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||Number of lapses||Standard Deviation|Mean
1414360|NCT01146600|Secondary|PVT Median Reaction Time at Week 1|"median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance)~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)"|week 1|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||Msec||Standard Deviation|Mean
1414361|NCT01146600|Primary|Psychomotor Vigilance Task (PVT) Reaction Time|"Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance).~Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)"|week 2 of each intervention|Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)|||Msec||Standard Deviation|Mean
1414362|NCT01146457|Primary|Rate of Breakthrough Pain|Rate of breakthrough pain is the number of episodes of breakthrough pain divided by the number of hours of labor. Time measured from placement of the neuraxial anesthetic, until delivery of the neonate. Because duration of labor is different for all patients, the rate of breakthrough pain per hour is used as the primary outcome.|Participants were followed for the duration of delivery, an average of 7 hours||||episodes of breakthrough pain per hour||Standard Deviation|Mean
1414363|NCT01146418|Secondary|Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)|The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.|From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)|FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.|||Percentage of Participants||95% Confidence Interval|Number
1414364|NCT01146418|Primary|Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)|The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).|Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)|Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.|||Percentage of Participants||95% Confidence Interval|Number
1414365|NCT01146379|Primary|Change in Action Research Arm Test (ARAT) Score Per Week|The Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week.|9 weeks||||change in units on a scale/week||Standard Error|Mean
1414366|NCT01146288|Primary|Renal Vascular Resistance (mm Hg/[ml/Min])||baseline and after diuretics administration||||mm Hg/[ml/min]||Standard Deviation|Mean
1414367|NCT01146288|Primary|Change in GFR (ml/Min)||baseline and after diuretics administration||||ml/min||Standard Deviation|Mean
1414368|NCT01146275|Primary|To Evaluate the Long Term Safety of Macrolane in Breast Enhancement|"To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation.~Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"|7 years +/- 6 months post treatment|Subjects that participated in study 31GB0106 was asked to partícipate in the study 31GB0904. 6 subjects signed Informed consent for this study.|||participants|||Number
1414369|NCT01146275|Primary|To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation|The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment.|7 years +/- 6months post treatment|MRI were performed by 4 women out of 6. One woman was pregnant and therefore not included and one did not want to perform MRI.|||participants with remaining product|||Number
1414370|NCT01146054|Secondary|Proportion of Participants Achieving Freedom From Local Progression (FFLP) in Patients Treated With Gemcitabine Followed by Fractionated Stereotactic Body Radiotherapy (SBRT) for up to 5 Years of Follow up.|"Freedom from local progression is defined as the time from start of SBRT treatment to local progression, with death as a competing risk. If the patient neither died nor experienced local progression, then patient was censored at last follow up.~The data was analyzed in a competing risk model and the outcome reported was the 1 year cumulative incidence rate."|Up to 5 years of follow up.||||Proportion of participants with FFLP||95% Confidence Interval|Number
1414371|NCT01146054|Secondary|To Determine the Overall Survival in Pancreatic Cancer Patients Treated With Gemcitabine and SBRT for up to 5 Years of Follow up.|Time to death was measured from start of treatment to until death. If death was not observed, the patient was censored at last follow up.|Up to 5 years of follow up.|The entire cohort.|||Months||95% Confidence Interval|Median
1414372|NCT01146054|Secondary|To Evaluate Progression Free Survival Following Gemcitabine and SBRT for up to 5 Years of Follow up .|"Time to progression free survival is measured from start of SBRT treatment until first progression event or death, which ever comes first. If the patient did not have an event, then the patient was censored at the last follow up.~The analysis was a Kaplan-Meier curve and the outcome was the median time to progression free survival."|Up to 5 years of follow up.|The whole cohort.|||Months||95% Confidence Interval|Median
1414377|NCT01145898|Primary|3-year Change in CRA EDV|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 36 month visits||||cm/sec||Standard Error|Mean
1414383|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits||||unitless||Standard Error|Mean
1414384|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1414385|NCT01145898|Primary|6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1414386|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)|Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.|Baseline and 6 month visits||||unitless||Standard Error|Mean
1414387|NCT01145898|Primary|6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)|Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1414388|NCT01145898|Primary|6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)|Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity|Baseline and 6 month visits||||cm/sec||Standard Error|Mean
1414389|NCT01145755|Secondary|MADRS Remission|A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6|6 weeks||||Participants|||Number
1414390|NCT01145755|Secondary|MADRS Response|A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.|6 weeks||||Participants|||Number
1414391|NCT01145755|Primary|MADRS Total Score Change From Baseline to Week 6|Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.|6 weeks||||scores on the scale||Standard Deviation|Mean
1414392|NCT01145638|Secondary|Change in Hemoglobin From Baseline to Week 24||24 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
1414393|NCT01145638|Primary|Change in Hb Concentration||Baseline week 4|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
1414394|NCT01145625|Other Pre-specified|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 52|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.|||hairs per centimeter squared||Standard Deviation|Mean
1414395|NCT01145625|Secondary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography|Baseline to Week 12|Intent-to-Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.|||hairs per centimeter squared||Standard Deviation|Mean
1414396|NCT01145625|Primary|Target Area Hair Count (TAHC)|Number of hairs in the area being examined as measured by macrophotography.|Baseline to Week 24|Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product.|||hairs per centimeter squared||Standard Deviation|Mean
1414397|NCT01145560|Secondary|Safety and Tolerability|Number of patients with treatment-emergent adverse events|All study visits (over 90 days following first dose)|Safety Analysis Set|||Participants|||Number
1414398|NCT01145560|Secondary|28-day Mortality|Number of patients who died over 28 days|Over 28 days following first dose|Intention-to-treat analysis set|||Participants|||Number
1414399|NCT01145560|Secondary|7-day Mortality|Number of patients who died over 7 days|Over 7 days following first dose|Intention-to-treat analysis set|||Participants|||Number
1414400|NCT01145560|Primary|Ventilator-free Days (VFDs) Over 28 Days|Number of ventilator-free days (VFDs)|Over 28 days following first dose|Intention-to-treat analysis set|||Days||Full Range|Median
1414401|NCT01145547|Primary|Mean Area Under the Curve for Rise in Breakfast Post-prandial.|Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.|Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast||||min x (mmol/l)||Standard Deviation|Mean
1414402|NCT01145508|Primary|Overall Survival|Overall survival is defined as the time from randomization to death or the date of last known alive.|Assessed every 3 months for 2 years, and then every 6 months for 3 years|All randomized patients are included in the analysis.|||Months||95% Confidence Interval|Median
1414403|NCT01145495|Secondary|Time to Best Response|Kaplan-Meier method will be used.|Up to 10 years|||||||
1414404|NCT01145495|Secondary|Time to Disease Progression|Kaplan-Meier method will be used.|Up to 10 years|||||||
1414405|NCT01145495|Secondary|Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Data will be summarized using frequency tables.|Up to 10 years|||||||
1414406|NCT01145495|Primary|Number of Participants Who Achieved a Complete Response|Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.|At 12 months|At the time of analysis, 54 participants had adequate to evaluate response.|||participants|||Number
1414407|NCT01145482|Secondary|Memory|Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance|15 minutes post insulin or placebo administration||||units on a scale||Standard Deviation|Mean
1414408|NCT01145482|Primary|Cerebral Glutamate Concentration|Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.|15 minutes post insulin or placebo administration|per protocol|||ratio||Standard Deviation|Mean
1414409|NCT01145417|Secondary|Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8)|PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated “Over past 2 weeks, how often bothered by any of following problems?”: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.|Baseline|SAF population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1414410|NCT01145417|Secondary|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Baseline up to Week 25|SAF included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.|||participants|||Number
1414411|NCT01145417|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)|PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1414412|NCT01145417|Secondary|Visual Analogue Scale for Pain (VAS-pain)|Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, 8, 12, 16, 20, 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants who were evaluable at specific time points for each arm group, respectively.|||millimeter (mm)||Standard Deviation|Mean
1414413|NCT01145417|Secondary|36-Item Short-Form Health Survey (SF-36)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Week 24|ITT population included all enrolled participants who took at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific parameter for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
1414414|NCT01145417|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
1414415|NCT01145417|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days.|Baseline, Week 24|ITT population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for specific question for each arm group, respectively.|||hours||Standard Deviation|Mean
1414425|NCT01145053|Secondary|Nocturnal Sleep|Nocturnal Sleep is rating 1 to 5 score based on patient’s diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 308 patients recorded the Nocturnal Sleep.|||Units on a scale||Standard Deviation|Mean
1414542|NCT01144026|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|5 weeks|all participants enrolled were analyzed|||ng/mL||Full Range|Median
1414416|NCT01145417|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded “Yes/No” to Question 1: Are you currently employed (working for pay)? are reported.|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled participants who had at least one dose of open label study drug. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Here ‘n’ signifies participants evaluable at given time point for each arm group, respectively.|||participants|||Number
1414417|NCT01145417|Primary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study treatment|Safety population (SAF) included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment.|||participants|||Number
1414418|NCT01145391|Secondary|Clinical Inertia|"Definition of clinical inertia: failure of a primary care physician to initiate/intensify anti-hypertensive medications AND the failure to provide behavioral counseling to lower blood pressure during a clinic visit where blood pressure is elevated above 140/90 mm Hg. The clinical inertia measure is the percentage of clinic visits with clinical inertia present divided by the total number of clinic visits.~We report a change in group mean levels of clinical inertia from baseline to 9 months post-randomization. Negative values for clinical inertia represent a decrease in the percentage of clinic visits where clinical inertia was present. Pre-randomization clinical inertia was assessed in the last 2 clinic visits prior to randomization, and post-randomization inertia was assessed in the first 2 post-randomization visits.~Hypothesis: clinical inertia will be significantly greater in the usual care compared with intervention group in the post-randomization period."|Baseline, 9 months||||% visits with inertia present||95% Confidence Interval|Number
1414419|NCT01145391|Primary|Blood Pressure|Hypothesis: compared with patients who receive usual care, patients who receive intervention will have an average systolic blood pressure that is at least 5 points lower 9 months after randomization.|Baseline, 9 months|Intention-to-treat analyses using restricted maximum likelihood (REML) for a repeated measures model with incomplete data (SAS Proc Mixed). As this assumes that the occurrence of missing follow-up data depends only on observed data (i.e., pre-randomization values), we also performed a sensitivity analysis using the method proposed by Little.|||mm Hg||95% Confidence Interval|Mean
1414420|NCT01145352|Secondary|Percentage of Participants With Overall Improvement On Physician's Assessment.|Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.|||percent||95% Confidence Interval|Number
1414421|NCT01145352|Primary|Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|24 weeks|The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
1414422|NCT01145352|Primary|Number of Unlisted Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.|||events|||Number
1414423|NCT01145352|Primary|Number of Participants With Serious Treatment-Related Adverse Events of Etanercept|Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.|||participants|||Number
1414424|NCT01145352|Primary|Number of Participants With Treatment-Related Adverse Events of Etanercept|Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.|24 weeks|The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.|||participants|||Number
1414613|NCT01143389|Primary|Change in Maximum Keratometry From Baseline to 6 Months After Treatment|Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.|6 months|Per protocol population|||diopters||Standard Deviation|Mean
1414426|NCT01145053|Secondary|Shortness of Breath|Shortness of Breath is rating 1 to 6 score based on patient’s diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Shortness of Breath.|||Units on a scale||Standard Deviation|Mean
1414427|NCT01145053|Secondary|Amount of Sputum|Amount of Sputum is rating 1 to 4 score based on patient’s diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Amount of Sputum.|||Units on a scale||Standard Deviation|Mean
1414428|NCT01145053|Secondary|Cough Frequency|Cough frequency is rating 1 to 4 score based on patient’s diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Cough Frequency .|||Units on a scale||Standard Deviation|Mean
1414429|NCT01145053|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 105 patients measured FEV1 .|||L||Standard Deviation|Mean
1414430|NCT01145053|Secondary|Effectiveness|Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.|Week 52|The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set.|||Patients|||Number
1414431|NCT01145053|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients|||Patients|||Number
1414432|NCT01145001|Secondary|Continuous Abstinence During Treatment|We will also examine continuous abstinence during the six week treatment period by urine analysis each week.|6 weeks|this is the intent to treat group-all starters (not treatment completers)|||consecutive days of abstinence||Standard Deviation|Mean
1414433|NCT01145001|Primary|Abstinence Rates at the End of Treatment|Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.|6 weeks||||percentage of participants not smoking|||Number
1414434|NCT01144949|Secondary|Time to Spontaneous Stone Passage (All Stones)|Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries.|4 weeks|ITT population|||days||Standard Error|Mean
1414435|NCT01144949|Primary|Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter.|4 weeks|This endpoint analyzed all subjects in the ITT population, defined as randomized and received at least one dose of study drug (115 in the 8 mg silodosin arm, 117 in the placebo arm)|||participants|||Number
1414436|NCT01144949|Secondary|Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones)|At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject’s daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.|||units on a scale||Standard Deviation|Mean
1414437|NCT01144949|Secondary|Outpatient Narcotic Analgesic Use for Pain Relief|Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.|4 weeks|ITT population|||Days||Standard Deviation|Mean
1414438|NCT01144949|Secondary|Time to Spontaneous Stone Passage (Distal Stones)|Time to stone passage for distally-located stones is assessed by entries in subject diaries.|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.|||days||Standard Error|Mean
1414439|NCT01144949|Primary|Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures.|"The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography.~For this outcome measure, analysis includes only those stones located in the distal ureter."|4 weeks|Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm.|||participants|||Number
1414440|NCT01144715|Secondary|Stroke Impact Scale (SIS)|Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.|End of treatment at 8 weeks post enrolment||||units on a scale||Standard Deviation|Mean
1414441|NCT01144715|Secondary|Fugl-Meyer Upper Extremity Test|Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0–2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.|End of Treatment at 8 weeks post enrolment||||units on a scale||Standard Deviation|Mean
1414442|NCT01144715|Secondary|Wolf Motor Function Test|The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.|End of treatment at 8 weeks post enrolment||||Seconds||Standard Deviation|Geometric Mean
1414443|NCT01144715|Primary|Action Research Arm Test (ARAT)|The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.|End of treatment at 8 weeks post enrolment||||units on a scale||Standard Deviation|Mean
1414444|NCT01144624|Secondary|Pharmacodynamic Effects of AZD9773 on TNF-alpha|TNF-alpha levels over approximately 6 days following the first dose|Levels taken at baseline, over the dosing period (up to Day 5/6)|Safety analysis set|||pg/ml||Full Range|Median
1414445|NCT01144624|Primary|Pharmacokinetics of AZD9773|Maximum concentration at steady state (Cmax ss) for serum total and specific fabs|From first dose to last dose (Day 5/6 or at premature treatment discontinuation)|Pharmacokinetic analysis set|||ug/mL||Full Range|Geometric Mean
1414446|NCT01144624|Primary|Safety and Tolerability of AZD9773|Number of patients with treatment-emergent adverse events and number of patients who died over 28 days|28 day study period|Safety analysis set|||Participants|||Number
1414447|NCT01144598|Secondary|Evaluation of Rheumatoid Arthritis Treatments Duration|Time elapsed from onset of symptoms to diagnosis of rheumatoid arthritis (that is, from the first rheumatoid arthritis-related symptoms to diagnosis by a related specialist) and the time elapsed from diagnosis with rheumatoid arthritis to initiation of anti-tumor necrosis factor (anti-TNF) treatment.|Day 1|All participants with available information were included in the analysis.|||Months||Standard Deviation|Mean
1414448|NCT01144598|Secondary|Number of Deformities at Inspection|The number of joint deformities of the study participants.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414449|NCT01144598|Secondary|Sedimentation Rate|The erythrocyte (red blood cell) sedimentation rates of study participants were assessed.|Day 1|All participants with available information were included in the analysis.|||millimeters/hour||Standard Deviation|Mean
1414450|NCT01144598|Secondary|Anti-cyclic Citrullinated Peptide|Anti-cyclic citrullinated peptide (anti-CCP) test results.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414451|NCT01144598|Secondary|Rheumatoid Factor|Rheumatoid factor test results.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414452|NCT01144598|Secondary|Number of Comorbidities|Number of comorbid (coexisting) medical conditions of the study participants.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414453|NCT01144598|Secondary|Stiffness Duration|Participants' duration of morning joint stiffness.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414454|NCT01144598|Secondary|Biologics Usage|Biologic treatments participants were taking for their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414455|NCT01144598|Secondary|Number of Disease Modifying Anti-Rheumatic Drugs|The number of disease-modifying anti-rheumatic drugs (DMARDs) that participants were taking to treat their rheumatoid arthritis.|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414456|NCT01144598|Secondary|Evaluation of Visual Analog Scale (VAS) for Pain and Fatigue|Participants rated their pain and fatigue using a visual analog scale from 0 to 10, where 10 was the worst case.|Day 1|Participants who provided a visual analog scale rating for pain and fatigue were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1414457|NCT01144598|Secondary|Evaluation of Disease Activity Score 28 (DAS28)|"The DAS28 index measures disease activity in rheumatoid arthritis and is derived from the number of swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 100 mm line from very good to very bad). A higher score indicates worse control of disease. A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity."|Day 1|All participants with available information were included in the analysis.|||Participants|||Number
1414458|NCT01144598|Secondary|Evaluation of Global Rheumatoid Arthritis Severity Scale|Global rheumatoid arthritis severity was assessed by asking the participants to consider all the ways their rheumatoid arthritis affected them and to rate how they were doing on a scale of 0 (very well) to 10 (very poor).|Day 1|All participants with available information were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1414459|NCT01144598|Secondary|Work Limitation: Work Productivity and Activity Impairment (WPAI) Questionnaire|The WPAI evaluates the ability to work and perform regular activities. The scale yields 4 types of scores (range 0 to 100): Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1414807|NCT01141569|Secondary|Rate of Disease Stabilizations|Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study|Up to 12 months|Number of patients who had Stable disease|||participants|||Number
1414460|NCT01144598|Secondary|Work Limitation: Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI measures physical function by assessing the ability to perform daily living tasks. Each task is rated from 0 (no difficulty) to 3 (unable to do). The total score ranges from 0 to 3. Higher scores indicate impairment.|Day 1|All participants who completed the rating scales were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1414461|NCT01144598|Primary|Evaluation of Disease Duration: Time From Diagnosis to Disease-Modifying Anti-Rheumatic Drug Treatment in Rheumatoid Arthritis|The time elapsed from diagnosis of rheumatoid arthritis to initiation of treatment with disease-modifying anti-rheumatic drugs (DMARDs).|Day 1|All participants with available information were included in the analysis.|||Months||Standard Deviation|Mean
1414462|NCT01144455|Primary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year||||days||95% Confidence Interval|Median
1414463|NCT01144442|Primary|Feasibility of HIPC in Recurrent Disease Setting|We will determine feasibility based on the proportion of patients who complete 6 prescribed cycles of second line chemotherapy after undergoing the HIPC procedure.|6 months||||participants|||Number
1414464|NCT01144442|Secondary|Overall Survival|Overall survival will be defined as time from date of surgery to date of death or censored at the date of last documented contact for patients still alive.|Up to 5 Years|||||||
1414465|NCT01144442|Secondary|Progression-free Survival|Disease progression will be defined as time from surgery to first of either an increase in CA125 from post-treatment value (to a value greater than 100 or doubling of nadir CA125 levels) or new/increasing measurable disease by CT scan as defined by RECIST criteria, (secondary recurrence) or censored at date of last contact for patients still alive and who have no progressed or recurred (from date of surgery to disease progression).|Up to 5 Years|||||||
1414466|NCT01144442|Secondary|Quality of Life Measurements|The quality of life measurements (version 4 of the FACT-O questionnaire) will be summed over each subscale and overall and comparisons will be made using t-tests at distinct visits.|Baseline, 6 Weeks Post Surgery, Every 3 Weeks Up to Week 27|||||||
1414467|NCT01144442|Primary|Clinical Response|We will summarize clinical response as the proportion of patients with complete response. Complete response will be defined as normalization of CA125. - After 6 cycles of Second Line Adjuvant Chemotherapy.|After 6 cycles of Paclitaxel & Carboplatin (Week 21 up to 27)||||participants|||Number
1414468|NCT01144416|Secondary|Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event|The number of participants who started stimulation but did not undergo embryo transfer due to (S)AEs will be compared between the treatment groups.|Up to time of embryo transfer (maximum of 24 days after start of study drug)|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.|||participants|||Number
1414469|NCT01144416|Secondary|Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)|"Grade II (moderate OHSS) is characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea.~Grade III (severe OHSS) is characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm, may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause hemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena."|Up to approximately 1 month after oocyte pick-up|All-Subjects-Treated (AST) Group, defined as all participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the active treatment they actually received.|||participants|||Number
1414470|NCT01144416|Secondary|Live Birth Rate|The live-birth rate is the percentage of participants with at least 1 live born infant after an ongoing pregnancy in the controlled ovarian stimulation (COS)treatment cycle relative to the number of participants treated.|Approximately nine months after embryo transfer|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to.|||Percentage of participants|||Number
1414471|NCT01144416|Secondary|Number of Oocytes Retrieved Per Attempt|The number of cumulus oocyte-complexes retrieved was summarized per treatment group and per attempt (= per started COS cycle).|Maximally 21 days after the start of study treatment.|Intent-To-Treat (ITT) Group, defined as all randomized participants who received one or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. The number of oocytes retrieved were set to zero for participants who did not have oocyte retrieval.|||Number of oocytes||Standard Deviation|Mean
1414472|NCT01144416|Primary|Percentage of Participants With a Vital Pregnancy|Vital pregnancy was defined as the presence of at least 1 fetus with heart activity at least 35 days (≥5 weeks) after embryo transfer in the controlled ovarian stimulation (COS) treatment cycle|Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days.|Intent-To-Treat Group: all randomized participants who received 1 or more dose(s) of SCH 900962 or recFSH. Participants were grouped according to the treatment they were randomized to. Participants who did not have embryo transfer or who were lost to follow-up before the ultrasound assessment to confirm vital pregnancy were counted as non-pregnant.|||percentage of participants|||Number
1414473|NCT01144403|Secondary|Number of Participant With Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to 50 months (approximately)|Safety population included all the participants who had received at least one dose of study treatment.|||participants|||Number
1414577|NCT01143701|Primary|Parent-rated ADHD Symptoms|Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.|||scores on a scale|Participants|Standard Deviation|Mean
1414474|NCT01144403|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.|||days||95% Confidence Interval|Median
1414475|NCT01144403|Secondary|Overall Survival (OS)|Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.|From the time of enrollment until death due to any cause (up to 50 months [approximately])|Efficacy population included all the participants who had received at least one dose of study treatment.|||days||95% Confidence Interval|Median
1414476|NCT01144403|Primary|Overall Response Rate (ORR)|Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.|Up to 50 months (approximately)|Efficacy population included all the participants who had received at least one dose of study treatment.|||percentage of participants|||Number
1414477|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP)||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline serum N-terminal extension propeptide of type I collagen value.|||nanograms/milliliter||Inter-Quartile Range|Median
1414478|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Osteocalcin||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline osteocalcin value.|||micrograms/liter||Inter-Quartile Range|Median
1414479|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline serum type I collagen fragment value.|||nanograms/milliliter||Inter-Quartile Range|Median
1414480|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)||Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline bone-specific alkaline phosphatase value.|||units/liter||Inter-Quartile Range|Median
1414481|NCT01144377|Secondary|Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)|"Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate."|Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline total radius of the wrist BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
1414482|NCT01144377|Secondary|Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)|"Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.~Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate."|Baseline, 24 weeks and 52 weeks and 64 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline femoral neck or total hip BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
1414483|NCT01144377|Secondary|Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)|"Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.~Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate"|Baseline, 12 weeks and 24 weeks and 64 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
1414484|NCT01144377|Primary|Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)|"Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).~Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.~Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate."|Baseline, 52 weeks|Participants who received at least one dose of study drug with baseline and at least one post-baseline lumbar spine BMD value.|||g/cm^2||95% Confidence Interval|Least Squares Mean
1414485|NCT01144364|Secondary|Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months|DOR was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of FL. Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the competing risk approach, deaths for causes other than FL were considered as competing events. DOR was estimated with the cumulative incidence of progression, relapse, or death as a result of FL.|Months 12, 24, and 34|ITT Population|||percentage of participants||95% Confidence Interval|Number
1414500|NCT01144338|Secondary|Secondary Efficacy Outcome CV Death|Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1423352|NCT01070784|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and 52 week after||||*10000/μl||Standard Deviation|Mean
1414486|NCT01144364|Secondary|Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months|Duration of response (DOR) was defined for all participants who achieved a response (CR, CRu, and PR) at Month 3 or later, after the completion of induction phase and was measured from the date of randomization until the date of progression, relapse, or death as a result of follicular lymphoma (FL). Participants without relapse, progression, or death for causes other than FL were censored at their last assessment date. Analyses on this endpoint were performed with two different approaches. For the traditional approach, duration of response was estimated as the proportion of participants alive without progression or relapse of disease with the Kaplan-Meier method.|Months 12, 24, and 34|ITT Population|||percentage of participants||95% Confidence Interval|Number
1414487|NCT01144364|Secondary|Percentage of Participants With a Molecular Response in the Induction Phase|Molecular responders were defined as the proportion of CR/CRu participants with a positive bcl-2/IgH (non-Hodgkin's Lymphoma [NHL] marker) at baseline, whose laboratory values were undetectable after treatment.|Months 5 and 8|IP population; only participants with a positive bcl-2/IgH (NHL marker) at baseline were included in the analysis.|||percentage of participants|||Number
1414488|NCT01144364|Secondary|Percentage of Participants With a Response During the Induction Phase|Participants without a response assessment (due to any reasons) were considered as non-responders.|Months 1 to 8|ITT population.|||percentage of participants|||Number
1414489|NCT01144364|Primary|PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. PFS was estimated using Kaplan-Meier methods.|12, 24, and 34 months|ITT population|||percentage of participants||95% Confidence Interval|Number
1414490|NCT01144364|Secondary|OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months|OS from enrollment was defined as the date of enrollment to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population|||percentage of participants||95% Confidence Interval|Number
1414491|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants With Death|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.|||percentage of participants|||Number
1414492|NCT01144364|Secondary|Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months|OS from randomization was defined as the date of randomization to the date of death from any cause. Participants still alive at the time of the final analysis were censored at the date of the last contact. Estimates of the OS function were made by the Kaplan-Meier product-limit method.|12, 24, and 34 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
1414493|NCT01144364|Secondary|Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months|DFS was defined for all participants who achieved a complete response (CR) or unconfirmed CR (CRu) at Month 3 or later, after the completion of induction phase and was measured from the time of randomization to the date of relapse or death as a result of lymphoma or acute toxicity of treatment. Participants without relapse were censored at their last assessment date. Estimates of DFS were made using Kaplan-Meier product-limit method.|12, 24, and 36 months|ITT population|||percentage of participants||95% Confidence Interval|Number
1414494|NCT01144364|Secondary|Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months|PFS from enrollment was measured from the date of enrollment to the date of disease progression, relapse, or death from any cause. Responding participants and participants who were lost to follow-up were censored at their last assessment date. Estimates of PFS function were made with the Kaplan-Meier product-limit method.|12, 24, and 36 months|IP population|||percentage of participants||95% Confidence Interval|Number
1414495|NCT01144364|Primary|Percentage of Participants With Disease Progression or Death|PFS from randomization was measured from the date of randomization to the date of documented disease progression, relapse, or death from any cause. PFS function was estimated using Kaplan-Meier product-limit method. Responding participants and participants who were lost to follow up were censored at their last assessment date.|12, 24, and 34 months|ITT population|||percentage of participants|||Number
1414496|NCT01144338|Secondary|Secondary Efficacy Outcome Hospitalization for HF|The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1414497|NCT01144338|Secondary|Secondary Efficacy Outcome Hospitalization for ACS|The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1414498|NCT01144338|Secondary|Secondary Efficacy Outcome Stroke|Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1414499|NCT01144338|Secondary|Secondary Efficacy Outcome MI|Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1414501|NCT01144338|Secondary|Secondary Efficacy Outcome All-Cause Mortality|The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1414502|NCT01144338|Primary|Primary Safety Outcome MACE Events|"The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.~The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo."|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1414503|NCT01144338|Primary|Primary Efficacy Outcome MACE Events|"The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.~The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo."|Time to first event. Information collected during study period (anticipated to be up to 7.5 years).|ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.|||Participants|||Count of Participants
1414504|NCT01144299|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period (From Day 0 up to Day 21)||||subjects|||Number
1414505|NCT01144299|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1414506|NCT01144299|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data|||subjects|||Number
1414507|NCT01144299|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated Cohort, on subjects with available data|||subjects|||Number
1414508|NCT01144299|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||subjects|||Number
1414509|NCT01144299|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||fold increase||95% Confidence Interval|Mean
1414510|NCT01144299|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||subjects|||Number
1414511|NCT01144299|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||subjects|||Number
1414512|NCT01144299|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data|||titer||95% Confidence Interval|Geometric Mean
1414513|NCT01144286|Secondary|Dose-response of Clinical and Mycological (Global)Therapeutic Response|Global therapeutic response at day 8± 2 days. Safety and tolerability.|Day 8 ± 2 days|Dose response tested using logistic regression-linear coefficient for treatment effect.Assuming response rate 80% for 600 mg, 75% for 300 mg, 65% for 150 mg and 50% for the placebo group, sample size of 45 subjects in each group have 90% power to detect linear dose response with 0.05 two-sided test of trend based on the logistic model.|||percentage of cured participants||95% Confidence Interval|Number
1414514|NCT01144286|Primary|Dose-response of Clinical and Mycological (Global) Therapeutic Response|"Global therapeutic response at day 26± 4 days (TOC- Test-of-Cure visit).Global therapeutic response is a composite endpoint using the clinical (signs and symptoms) and the mycological cures (microbiological culture), according to FDA guideline Vulvovaginal Candidiasis —Developing Antimicrobial Drugs for Treatment."|day 26 ± 4 days|The full analysis set (FAS) was the primary population for the analysis of all efficacy endpoints. The FAS was defined as all randomized subjects who received at least 1 dose of a study drug.Subjects in the FAS were analyzed according to randomized treatment group.|||percentage of patients cured||95% Confidence Interval|Number
1414515|NCT01144182|Secondary|Emotional Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-25, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414533|NCT01144143|Primary|Change in Cellular Infiltrates From Day 0 to Day 28|Cellular infiltration scored 0 to 3|Day 0 to Day 28|In the MPA arm, one subject was excluded from the analysis because their biopsy sample was of insufficient quantity to be processed in the lab.|||Participants|||Count of Participants
1414516|NCT01144182|Primary|Heart Failure Specific Quality of Life|Measured by Minnesota Living with Heart Failure Questionnaire. Scores range from 0-105, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the MLHFQ, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414517|NCT01144182|Secondary|Physical Subscale of Heart Failure Specific Quality of Life|Subscale of the Minnesota Living with Heart Failure Questionnaire (HF-specific quality of life measure). Scores range from 0-40, with higher scores indicating poorer QOL.|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the Minnesota Living with Heart Failure Questionnaire, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414518|NCT01144182|Primary|General Quality of Life From the Standardized Physical Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414519|NCT01144182|Secondary|Mental Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414520|NCT01144182|Secondary|Role Emotional|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414521|NCT01144182|Secondary|Social Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414522|NCT01144182|Secondary|Vitality|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414523|NCT01144182|Secondary|General Health|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414524|NCT01144182|Secondary|Pain Index|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414525|NCT01144182|Secondary|Role Physical|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36. Additionally, a second participant in CBP did not complete the role physical subscale items, leaving a total of 49 in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414526|NCT01144182|Secondary|Physical Functioning|Subscale of General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414527|NCT01144182|Secondary|Standardized Mental Component Score|Assesses General Quality of Life from VR-36, with scores ranging from 0 to 100 and higher score indicating better quality of life|3 months after discharge|51 patients in CBP and 47 patients in QIP had a follow-up visit. However, 1 participant in each arm did not complete the VR-36, such that there are only 50 participants analyzed in CBP and 46 in QIP for this outcome.|||units on a scale||Inter-Quartile Range|Median
1414528|NCT01144143|Secondary|Change in Serum SAA Levels Day 0 to Day 56|Serum Amyloid A|Day 0 to Day 56||||ug/ml||Standard Deviation|Mean
1414529|NCT01144143|Secondary|Change in Serum CRP Day 0 to Day 56|Serum measure of systemic inflammation|Day 0 to Day 56||||mg/dl||Standard Deviation|Mean
1414530|NCT01144143|Secondary|Change in Levels of Serum IL-6||Change from Day 0 to Day 56||||pg/ml||Standard Deviation|Mean
1414531|NCT01144143|Secondary|Change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score Target Knee|The WOMAC questionnaire is used to evaluate the condition of patients with osteoarthritis. Patients answer questions based on how they are feeling. The questionnaire has a total of 24 questions which deal with pain, stiffness and physical function. Participants are asked to respond to how difficult it is for them to do/complete an activity. There is a total possible score of 96. A score of 0 equals no difficulty completing any of the 24 activities. A score of 96 would indicate extreme difficulty with all activities.|Change from Day 0 to Day 56||||units on a scale||Standard Deviation|Mean
1414532|NCT01144143|Secondary|Change in Joint Effusions From Day 0 to Day 56 Target Knee|Outcome calculated based on Physician observation of joint swelling from 0-3. A score of 0 = no effusion,1 = positive “bulge,” 2 = moderate effusion, 3 = tense effusion. The outcome represents the change in means between the two time points.|Change from Day 0 to Day 56||||units on a scale||Standard Deviation|Mean
1414543|NCT01143896|Primary|Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months|The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value.|From Baseline to 12 months||||Depression Free Days (DFDs)||Standard Deviation|Mean
1414544|NCT01143896|Primary|Depression Care: Depression Remission|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5.|Baseline and 12 months||||participants|||Number
1414545|NCT01143896|Primary|Depression Care: Treatment Response|Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline.|Baseline and 12 months||||participants|||Number
1414546|NCT01143896|Secondary|Medication Adherence: Medication Possession Ratio|Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day’s supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement.|12 months||||medication posession ratio||Standard Deviation|Mean
1414547|NCT01143896|Secondary|Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received|Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe.|12 months||||proportion of QIs met||Standard Deviation|Mean
1414548|NCT01143896|Primary|Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment|Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise.|12 months|intent to treat|||participants|||Number
1414549|NCT01143883|Primary|Surgical Site Infection|We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.|Day of surgery up to 30 days post operatively|The number of participants analyzed was based on the number who received treatment according to their randomized group and were treated according to study protocol|||percentage of participants with SSI|||Number
1414550|NCT01143870|Secondary|Change in Hemoglobin A1C Over 12 Months From Enrollment||12 months|||||||
1414551|NCT01143870|Secondary|The Number of Hemoglobin A1C Values Checked During 6 Month Study Period||6 months|||||||
1414552|NCT01143870|Secondary|Change in Patient Understanding of Disease State|Change in patient understanding of disease state as assessed by questionnaire administered pre- and post-intervention.|2 weeks on average|||||||
1414553|NCT01143870|Primary|Change in Percent of Glycosylated Hemoglobin 6 Months Following Enrollment||6 months from enrollment||||Percent of glycosylated hemoglobin||Standard Error|Mean
1414554|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in Body Mass Index (BMI)|The BMI was measured in kg/m^2 and was reported at baseline and at the Month 6. BMI = weight (kg)/[(height (m) x height (m)] and was measured to 1 decimal point precision.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had BMI available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
1414555|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the Multidimensional Fatigue Inventory (MFI) Total Score|The MFI is a 20-item self-reported instrument designed to measure fatigue. Five scales measure different modes of fatigue: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), reduced motivation (4 items), and reduced activity items (4 items). The scores for each item range from 1 to 5. Each subscale includes 4 items with 5-point Likert scales and subscale scores range from 4 to 20 with a higher score indicating greater fatigue. The percent change=[(MFI value at Month 6-MFI value at baseline)/MFI baseline value] X 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an MFI score available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
1414556|NCT01143818|Secondary|Percent Change From Baseline to Month 6 in the International Index of Erectile Function (IIEF) Total Score|The International Index of Erectile Function (IIEF) test is a validated 15 question assessment designed to measure changes in erectile function (6 items), orgasmic function (2 items), sexual desire (2 items), intercourse satisfaction (3 items), and overall satisfaction (2 items). The scores ranged from 0 to 5 on each item with a lower score indicating greater dysfunction. A total IIEF score of 0 (minimum) to 75 (maximum) was possible and represented the sum of all the items at baseline and Month 6. The percent change = [(IIEF value at Month 6-IIEF baseline value)/IIEF baseline value]x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an IIEF score available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
1414575|NCT01143714|Primary|Change in Wound Area|The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period|4 Weeks|Sample size originally set at 100 to provide 80% power, a=0.05. Interim analysis when enrollment reached 50 indicated results would not change with additional enrollment. Intent-to-treat used for primary inference; Missing values imputed by method of population mean and last observation carried forward (wound area).|||percentage of average change in wound||Standard Error|Least Squares Mean
1414557|NCT01143818|Primary|Percent Change From Baseline to Month 6 in Aging Male Symptoms (AMS) in Mean Total Score|The Aging Male Symptoms (AMS) test is self-administered and designed to assess symptoms of aging with a rating from none (0) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total scores range from 17 (minimum) to 85 (maximum). The AMS total score was reported at baseline and at Month 6 and represented the sum of all the items. The percent change from baseline was calculated as the [(AMS value at Month 6 - AMS value at baseline)/baseline value] x 100.|Baseline to Month 6|The full analysis set included all participants in the safety analysis set who had an Aging Male Symptoms (AMS) score available at baseline and Month 6.|||Percent Change||Standard Deviation|Mean
1414558|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior six months|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.|||percent days of drug use||Standard Deviation|Mean
1414559|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||percent days of drug use||Standard Deviation|Mean
1414560|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depression)to 63 (severe depression)|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1414561|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1414562|NCT01143792|Secondary|Depressive Symptoms|Beck Depression Inventory - II (BDI-II) total score, range from 0 (no depresion)to 63 (severe depression)|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1414563|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior six months.|Twelve months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||participants who always used condoms|||Number
1414564|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Six months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||participants who always used condoms|||Number
1414565|NCT01143792|Secondary|HIV Risk|Frequency of condoms use in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||participants who always used condom|||Number
1414566|NCT01143792|Primary|Substance Use|Percentage of substance use days in prior three months.|Three months|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.|||percent days of drug use||Standard Deviation|Mean
1414567|NCT01143766|Secondary|Median Nausea Score at Time of Discharge|Assess the effect of a single 900mg dose of gabapentin on nausea at time of discharge, measured by a visual analog scale ranging from 0 (worst nausea) to 100 (no nausea).|At time of discharge post-procedure||||units on a scale||Inter-Quartile Range|Median
1414568|NCT01143766|Secondary|Median Anxiety Score at Time of Discharge|Assess the effect of a single 900mg dose of gabapentin on anxiety at time of discharge, measured by a visual analog scale ranging from 0 (worst anxiety) to 100 (no anxiety).|At time of discharge post-procedure||||units on a scale||Inter-Quartile Range|Median
1414569|NCT01143766|Secondary|Median Pain Score at Time of Discharge|Assess the effect of a single 900mg dose of gabapentin on pain at time of discharge, measured by a visual analog scale ranging from 0 (worst pain) to 100 (no pain).|At time of discharge post-procedure||||units on a scale||Inter-Quartile Range|Median
1414570|NCT01143766|Secondary|Number of Participants With Sedation-Related Adverse Events|Sedation-related adverse events|At time of discharge post-procedure||||participants|||Number
1414571|NCT01143766|Primary|Dosing Requirements|Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements.|At time of discharge post-procedure|TOTAL DOSE OF MEPERIDINE|||TOTAL DOSE OF MEPERIDINE, mg||Inter-Quartile Range|Median
1414572|NCT01143727|Secondary|Percent Change in Wound Area||28 days|Intent-to-Treat|||percentage change from baseline area||Standard Deviation|Mean
1414573|NCT01143727|Primary|Wound Appearance|Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.|28 days|12 subjects initially for this exploratory study. 17 subjects enrolled to ensure 12 evaluable. Intent-to-treat used for primary inference. Missing values imputed by method of population mean (BWAT-m) and last observation carried forward (wound area).|||units on a scale||Standard Deviation|Mean
1414574|NCT01143714|Secondary|Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)||12 weeks|Intent-to-Treat population|||debridements||Standard Error|Least Squares Mean
1414576|NCT01143701|Primary|Teacher-rated ADHD Symptoms|Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.|12 months|Analyses only included patients who had a post-intervention teacher-rated ADHD scale. Hierarchical Modeling accounted for clustering of patients nested within providers and providers nested within practices.|||scores on a scale|Participants|Standard Deviation|Mean
1414578|NCT01143688|Secondary|Asthma Symptoms|Subjective change in asthma symptoms on a visual-analogue scale with scores ranging from 0 (no positive change) to 10 (complete positive change). These subjective responses were then converted to percent change during the 2 hours by multiplying each score by 10. Each of these individual subject scores were then averaged to produce an average percent change in symptoms.|Assesed over 2 hours during each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.||||percent change in symptoms||Standard Error|Mean
1414579|NCT01143688|Primary|Change in FEV1|The baseline FEV1 (before treatment) was subtracted from the maximum FEV1 recorded during the 2 h period following treatment. This difference value was then converted into percent improvement by dividing by baseline FEV1 and multiplying by 100. Each treatment was given 3 times to each patient, so we averaged the 3 values to yield the mean percent change in FEV1 for each condition.|FEV1 was assessed every 20 minutes for 2 hours at each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.|Each patient went through each treatment arm (albuterol, placebo inhaler, placebo acupuncture, and no-intervention) once in block 1, then again in block 2, and again in block 3, for a total of 12 interventions of the course of the study.|||percentage change in FEV1||Standard Error|Mean
1414580|NCT01143649|Primary|Cortical Oscillations - EEG|Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.|15 minutes|The brain oscillations measurements were only performed in the tACS study (Experiment 3).|||microVolt^2||Standard Deviation|Mean
1414581|NCT01143649|Primary|Cortical Excitability|"Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham).~The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison."|1 hour|The cortical excitability measurement (MEP) was performed in healthy participants involved in the tDCS+CIMT study (Experiment 2).|||percent change||Standard Deviation|Mean
1414582|NCT01143649|Primary|Jebsen Taylor Hand Function Test|Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.|2 weeks|The Jebsen Taylor Hand Function Test was only performed in the stroke study (Experiment 1).|||seconds||Standard Error|Mean
1414583|NCT01143636|Secondary|Diffuse Noxious Inhibitory Controls - DNIC.|DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).|baseline and at 2 weeks|patients with pelvic pain (Exp. 1).|||lb||Standard Deviation|Mean
1414584|NCT01143636|Secondary|Pain Pressure Threshold Test - PPT|Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1).|baseline and at 2 weeks|Patients with pelvic pain (Exp. 1).|||lb||Standard Deviation|Mean
1414585|NCT01143636|Secondary|Von Frey|This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus.|baseline and at 2 weeks|Patients with pelvic pain (Exp. 1).|||grams||Standard Deviation|Mean
1414586|NCT01143636|Secondary|Patient Global Assessment - PGA|"This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question how is your health overall on a scale going from 0 to 10 (0 being the worst, 10 being the best)."|2 weeks|Patients with pelvic pain (Exp. 1).|||units on a scale||Standard Deviation|Mean
1414587|NCT01143636|Secondary|Beck Depression Inventory - BDI.|BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression).|2 weeks|Patients with pelvic pain (Exp. 1).|||units on a scale||Standard Deviation|Mean
1414588|NCT01143636|Secondary|Mini Mental Scale - MMS|This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status.|2 weeks|Patients with pelvic pain (Exp. 1).|||units on a scale||Standard Deviation|Mean
1414589|NCT01143636|Secondary|Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain|The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).|2 weeks|This outcome measure was performed in patients with pelvic pain (Exp 1).|||units on a scale||Standard Deviation|Mean
1414590|NCT01143636|Secondary|Clinical Global Impression - CGI|This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement.|2 weeks|Patients with pelvic pain (Exp 1)|||units on a scale||Standard Deviation|Mean
1423968|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 6 hours after breakfast|Plasma samplesPlasma dopamine 6 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1414591|NCT01143636|Secondary|Quality of Life Scale (QOLS)|The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL.|2 weeks|We compared active and sham groups (Exp. 1)|||units on a scale||Standard Deviation|Mean
1414592|NCT01143636|Primary|Pressure Pain Threshold|"Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.~The change in pressure pain threshold (post minus pre intervention) is use for the analysis."|baseline and at 2 weeks|The pain pressure test is performed in healthy participants (exp 2).|||lb||Standard Deviation|Mean
1414593|NCT01143636|Primary|Pain Assessment|We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).|baseline and at 2 weeks|The VAS is performed in patients with pelvic pain (Experiment 1).|||units on a scale||Standard Deviation|Mean
1414594|NCT01143610|Secondary|Gain of Clinical Attachment Level|Investigation of clinical attachment level, probing depth and reduction of recession depth|9 months post-operatively|The unit of analysis was the site, since each participant contributed with more than one site to be treated|||mm|Participants|Standard Deviation|Mean
1414595|NCT01143610|Primary|Percentage of Root Coverage|Percentage of root coverage determined by: [area covered]/[total area to be covered] x 100 (in %)|Baseline, 9 months post-operatively|The unity of analysis was the site, since each participant contributed with more than one site for treatment|||percentage of area covered|Participants|Full Range|Mean
1414596|NCT01143402|Other Pre-specified|FACT-M Total Score|Summarized using descriptive statistics for each assessment time and by treatment group. The scores will be compared between treatment groups using a mixed effect model for repeated measures analysis method. Treatment difference will be estimated from the model for each assessment time.|Up to 5 years|||||||
1414597|NCT01143402|Other Pre-specified|Changes in Maximum Standardized Uptake Value on FLT-PET Scans|A paired student's t-test will be performed. Analysis of variance will also be performed to obtain the significance of FLT-PET uptake on each lesion between patients.|Baseline up to 60 minutes post injection|||||||
1414598|NCT01143402|Other Pre-specified|Change in PTEN|Correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
1414599|NCT01143402|Other Pre-specified|Change in p-ERK|Decrease in p-ERK will be correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
1414600|NCT01143402|Other Pre-specified|Change in p-AKT|Correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
1414601|NCT01143402|Other Pre-specified|Change in Ki67|Correlated with disease status using Fishers exact test.|Baseline up to 4 months|||||||
1414602|NCT01143402|Other Pre-specified|Apoptosis in the Paired Samples, Performed by Caspase 3 Cleavage|Changes will be assessed by a Wilcoxon test|Up to 5 years|||||||
1414603|NCT01143402|Other Pre-specified|PFS (Group 3)|Evaluated using a Simon mini-max design. Curves will be generated using Kaplan-Meier methodology.|4 months|||||||
1414604|NCT01143402|Other Pre-specified|Toxicity According to the National Cancer Institute Common Toxicity Criteria|Toxicity will be reported by type, frequency, and severity. Please see adverse events.|Up to 5 years|||||||
1414605|NCT01143402|Other Pre-specified|Response Rate (Complete and Partial Response)|Calculated along with a 95% confidence interval.|Up to 5 years|||||||
1414606|NCT01143402|Other Pre-specified|Overall Survival|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to death due to any cause, assessed up to 5 years|||||||
1414607|NCT01143402|Other Pre-specified|Objective Disease Progression|per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression|assessed up to 5 years|||||||
1414608|NCT01143402|Secondary|Median Overall Survival (Evaluable Randomized Patients)|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to death due to any cause, assessed up to 5 years||||Months||95% Confidence Interval|Median
1414609|NCT01143402|Primary|Progression-free Survival (PFS) (Evaluable Randomized Patients)|The primary analysis will be performed among the Gnaq/Gna11 mutant patients. A stratified logrank test will be performed stratified by mutation status, M stage, and number of prior systemic therapies for metastatic disease. Due to the potential for a large number of strata and small strata sizes, the standard asymptotic stratified logrank test will be verified for robustness utilizing a permutation reference distribution.|The time from randomization to the earlier date of objective disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) criteria or death due to any cause in the absence of progression, assessed up to 5 years|Analysis of progression-free survival in all evaluable randomized patients|||weeks||95% Confidence Interval|Median
1414610|NCT01143389|Secondary|Uncorrected Distance Visual Acuity (UDVA)|Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units. Lower numbers represent better vision; 0.0 corresponds to 20/20 vision without any type of correction such as glasses. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.|6 months|Per protocol|||logMAR||Standard Deviation|Mean
1414611|NCT01143389|Secondary|Corrected Distance Visual Acuity (CDVA)|Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR). Lower numbers represent better vision; 0.0 corresponds to 20/20 vision. Each increase of 0.1 on the logMAR scale corresponds to one less line read on the eye chart.|6 months|Per protocol|||logMAR||Standard Deviation|Mean
1414612|NCT01143389|Secondary|Pachymetry|Minimum corneal thickness measured by corneal tomography|6 months|Per protocol|||microns||Standard Deviation|Mean
1414614|NCT01143337|Secondary|Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|ACR components are tender joints count (TJC), swollen joints count (SJC), participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ‐DI]); and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).|LOCF (Week 12 or discontinuation time)||||percentage of change from baseline||Standard Deviation|Mean
1414615|NCT01143337|Secondary|Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components|"DAS28 (CRP) is calculated using TJC, SJC C-Reactive Protein ( CRP in mg/dL ), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity.~DAS28 (ESR) is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.~A negative change score indicates improvement. Higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity."|LOCF (Week 12 or discontinuation time)||||units on a scale||Standard Deviation|Mean
1414616|NCT01143337|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response|ACR 70 response is a decrease of at least 70 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)||||percentage of participants||95% Confidence Interval|Number
1414617|NCT01143337|Secondary|Percentage of Participants Achieving ACR 50 Response|ACR 50 response is a decrease of at least 50 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)||||percentage of participants||95% Confidence Interval|Number
1414618|NCT01143337|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response|ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count [TJC and SJC] and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ-DI]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).|Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)||||percentage of participants||95% Confidence Interval|Number
1414619|NCT01143324|Primary|Time to Surgery Recovery Day.|"The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.~Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors."|From date of surgery until date of surgery recovery day assessed up to hospital discharge.||||Days||Standard Deviation|Mean
1414620|NCT01143324|Secondary|Number of Patients That Returned to Work 12months After the Surgery.|Document number of participants that returned to work 12 months after surgery.|12 months after the surgery||||Participants currently working|||Number
1414621|NCT01143324|Secondary|ODI Difference 12 Months After the Surgery as Compared to Baseline.|Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|Baseline, 12 months||||Units on a scale||Standard Deviation|Mean
1414622|NCT01143324|Secondary|Document Adverse Events Occurrence Throughout the Study.|Document the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.|From Baseline until 12 months||||Number of reported adverse events|||Number
1414623|NCT01143324|Secondary|Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.|Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit.|Baseline, 12 months||||Participants|||Number
1414624|NCT01143324|Secondary|Proportion of Patients Needing Intervention at Adjacent Level(s).|Proportion of the patients needing intervention at adjacent level(s).|From Baseline until 12 months||||Participants|||Number
1414625|NCT01143324|Secondary|Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).|Proportion of the patients needing a second intervention at the treated level(s) (reoperation rates).|From baseline until 12 months||||Participants|||Number
1414626|NCT01143324|Secondary|Number of Patients Who Utilized Rehabilitation Programs|The number of patients who utilized rehabilitation programs was documented (when required).|From 6-12 months after the day of surgery||||Pts having rehab between 6-12 months|||Number
1423969|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 4 hours after breakfast|4 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1414627|NCT01143324|Secondary|Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.|Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.|12 months|One hundred and thirty one-level patients (=130 LEVELS) and 24 two-level patients (=48 LEVELS) were assessed for fusion at 12 months per CIP defined criteria.|||Fused levels|Participants||Number
1414628|NCT01143324|Secondary|EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.|EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent’s self-rated health on a vertical 20 cm VAS where the endpoints are labelled ‘Best imaginable health state’ at the top and ‘Worst imaginable health state’ at the bottom, having numeric values of 100 and 0 respectively.|Baseline, 12 months||||Units on a scale / Index||Standard Deviation|Mean
1414629|NCT01143324|Secondary|Leg Pain Intensity VAS Score as Compared to Baseline|"Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).~The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months||||Units on a scale||Standard Deviation|Mean
1414630|NCT01143324|Secondary|Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.|"Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS).~The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain."|Baseline, 12 months||||Units on a scale||Standard Deviation|Mean
1414631|NCT01143324|Primary|Time From Surgery to First Ambulation.|"The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures.~Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital."|From date of Surgery to date of First ambulation, assessed up to hospital discharge.||||Days from surgery to first ambulation||Standard Deviation|Mean
1414632|NCT01143272|Secondary|Total Number of Discontinuation or Change of Initially Prescribed Antibiotic||29 months||||participants|||Number
1414633|NCT01143272|Secondary|Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months||||bowel movements per day||Standard Deviation|Mean
1414634|NCT01143272|Secondary|Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea||29 months||||days||Standard Deviation|Mean
1414635|NCT01143272|Secondary|Incidence Density of Antibiotic-associated Diarrhea||29 months||||cases per year|||Number
1414636|NCT01143272|Secondary|Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins)||29 months||||episodes|||Number
1414637|NCT01143272|Secondary|Total Number of Clostridium Difficile-associated Diarrhea Episodes||29 months||||episodes|||Number
1414638|NCT01143272|Primary|Total Number of Antibiotic-associated Diarrhea Episodes||29 months||||Episodes|||Number
1414639|NCT01143259|Secondary|Hospital Cost|Total Cost of hospital stay inflation adjusted to 2010 dollars.|Upon discharge|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.|||Dollars||Full Range|Mean
1414640|NCT01143259|Primary|Measure of Improvement Over the Standard|Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date.|Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day]|The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population.|||Days in the hospital||Full Range|Mean
1414641|NCT01143207|Primary|MPA Concentration at Day 120 (C120)||day 120 after injection||||ng/mL||Standard Deviation|Mean
1414642|NCT01143207|Primary|MPA Concentration at Day 104 (C104)||day 104 after injection||||ng/mL||Standard Deviation|Mean
1414643|NCT01143207|Primary|MPA Concentration at Day 91 (C91)||day 91 after first injection||||ng/mL||Standard Deviation|Mean
1414644|NCT01143207|Primary|AUC 0-91 (Area Under Curve)||first 91 days following injection||||ng day/mL||Standard Deviation|Mean
1414645|NCT01143207|Primary|Tmax (Time to Cmax)||120 days following injection||||days||Inter-Quartile Range|Median
1414646|NCT01143207|Primary|Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))||120 days following injection||||ng/mL||Standard Deviation|Mean
1418879|NCT01108003|Primary|Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0|Number of participants with an adverse event.|14 days|All treated and eligible patients.|||participants|||Number
1414647|NCT01143142|Secondary|Vaccination of Daughter|With mother’s consent, daughter’s University of Michigan vaccination record will be accessed to determine whether daughter has received any doses of the HPV vaccine. If the University of Michigan vaccination record does not document a visit three months after the intervention, with mother’s consent, research staff will call mother at home to determine whether daughter has received any doses of the HPV vaccine.|Less than or equal to three months from the date of the intervention||||participants|||Number
1414648|NCT01143142|Primary|Mother's Intention to Vaccinate Daughter Against HPV|Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention. The scale ranges from 0-11 with higher numbers representing more positive intentions to vaccinate against HPV, and 5 being neutral intentions (i.e. neither positive nor negative). In this assessment we use this 11-point scale to assess vaccination before and after viewing the educational materials. The difference pre and post intervention in vaccination intention is calculated (min 0, max 11) and the mean of these differences are calculated for the control and intervention groups.|Date of intervention (one day)||||units on a scale||Full Range|Mean
1414649|NCT01143090|Secondary|Efficacy|Long-term efficacy of lurasidone in subjects with schizophrenia or schizoaffective disorder who have completed Study D1050289|6 months|||||||
1414650|NCT01143090|Primary|Adverse Events|Proportions of subjects with AEs, SAEs, and discontinuations due to AEs.|6 months|Safety population - One enrolled subject did not receive any study medication and was excluded from this summary.|||participants|||Number
1414651|NCT01143077|Secondary|Tolerability and Safety|Number of participants with Treatment Emergent Adverse Events and Serious Adverse Events|6 Weeks||||participants|||Number
1414652|NCT01143077|Primary|Time to Relapse of Psychotic Symptoms During 6 Weeks|"Relapse is defined as any occurrence of:~Insufficient clinical response~Exacerbation of underlying disease~Discontinuation due to an adverse event"|6 Weeks|Intend to treat|||days||Standard Deviation|Mean
1414653|NCT01143051|Primary|Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 minutes post-dose available and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
1414654|NCT01143051|Primary|Half-life (t1/2) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 min post-dose available; and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Full Range|Mean
1414655|NCT01143051|Primary|Time to Reach Peak Concentration (Tmax) for Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||min||Standard Deviation|Mean
1414656|NCT01143051|Primary|Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
1414657|NCT01143051|Primary|Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.|Pre-dose to 6 hours post-dose|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg*min/mL||Standard Deviation|Mean
1414658|NCT01143051|Secondary|Laboratory Analysis|Lab tests, including CBC, serum comprehensive metabolic panel, and urinalysis for all subjects, and urinary pregnancy test for women of child-bearing potential.|Screening, after each treatment and end of study, within 7 days of study visit 3|||||||
1414659|NCT01143051|Secondary|General Health Assessment|Physical examinations to assess general health|Screening and at or within 7 days after study visit 3|||||||
1414660|NCT01143051|Secondary|Hand Tremor|Hand tremor scores|at baseline, and at 10, 60, and 360 post-dose|||||||
1414661|NCT01143051|Secondary|Blood Values|Serum glucose and potassium levels;|at baseline, and at 15, 30, 60, 120, and 360 min post-dose|||||||
1414662|NCT01143051|Secondary|Telemetry and 12 Lead ECG Analysis|"Telemetry ECG recording of heart rate pre-dose, and during the initial 5 min post-dose.~A 12-lead ECG (Routine and QT / QTc intervals)at specified intervals"|within 30 min pre-dose, telemetry for 5 min post dose, 12 lead at 30, 90, and 360 min post-dose.|||||||
1414663|NCT01143051|Secondary|Vital Sign Analysis|Vital signs, i.e., blood pressure (SBP/DBP) and heart rate (HR);|at baseline, and at 10, 30, 60, 120, 180, and 360 min post-dose.|||||||
1414664|NCT01143051|Primary|Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine|Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.|0 to 30 minutes prior to dosing|Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.|||pg/mL||Standard Deviation|Mean
1414665|NCT01143038|Secondary|Number of Participants Who Developed Antibodies to Romiplostim|The number of participants who developed antibody formation (defined as negative at baseline and positive at post-baseline, transient or persistent) to romiplostim, endogenous thrombopoietin (eTPO), and thrombopoietin mimetic peptide (TMP, the peptide component of romiplostim) was summarized.|Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)|Safety analysis set participants with available results|||participants|||Number
1414666|NCT01143038|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other significant medical hazard. Whether an adverse event was treatment-related (TRAE) or not was determined by investigator.|From first dose date of romiplostim to end of study (up to 24 months).|Safety analysis set|||participants|||Number
1414667|NCT01143038|Secondary|Percentage of Participants With Splenectomy During the 12-month Treatment Period|If treatment with romiplostim was deemed ineffective or intolerable by the investigator, a splenectomy may have been performed.|12 months|Safety analysis set|||percentage of participants||95% Confidence Interval|Number
1414668|NCT01143038|Secondary|Percentage of Participants With ITP Remission|ITP remission was defined as maintaining every platelet count ≥ 50 x 10^9/L for at least 6 months in the absence of romiplostim and any other therapies to treat ITP.|Up to 24 months|Safety analysis set|||percentage of participants||95% Confidence Interval|Number
1414669|NCT01143038|Primary|Number of Months With Platelet Response During the 12-Month Treatment Period|The primary endpoint was the number of months a participant achieved a platelet response during the 12-month treatment period. A platelet response for any 1 month was defined as the median of platelet counts measured in the month ≥ 50 x 10^9/L. Platelet counts within 4 weeks following a rescue medication use or following splenectomy were considered non-response. Months without any platelet count measurement were considered as months with no platelet response.|12 months|Safety Analysis Set includes all participants who received at least 1 dose of romiplostim.|||months||Standard Error|Mean
1414670|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|12 months|14 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 15 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1414671|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|6 months|12 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 11 out of the 86 participants in the Education Control group with diabetes at baseline had missing HBA1C at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1414672|NCT01142908|Secondary|HBA1C in Diabetic Patients|Lab values collected at interview visit by lab personnel|Baseline|4 out of the 85 participants in the Pharmacist CVD group with diabetes at baseline and 2 out of the 86 participants in the Education Control group with diabetes at baseline had missing data due to not having HBA1C collected at baseline.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1414673|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|12 months|39 out of the 215 participants in the Pharmacist CVD group and 31 out of the 213 in the Education Control group had missing body mass index at 12 months due to missing the 12 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 12 month interview.|||kg/m^2||Standard Deviation|Mean
1414674|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|6 months|30 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing body mass index at 6 months due to missing the 6 month interview entirely or the interview was completed over the phone, or weight was not obtained at the 6 month interview.|||kg/m^2||Standard Deviation|Mean
1414675|NCT01142908|Secondary|Body Mass Index|Calculated from vitals (height & weight) obtained during interview|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 1 out of the 213 participants in the Education Control group had missing data due weight and/or height not collected at baseline.|||kg/m^2||Standard Deviation|Mean
1414676|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|12 months|34 out of the 215 participants in the Pharmacist CVD group and 27 out of the 213 in the Education Control group had missing cholesterol LDL at 12 months due to missing the 12 month interview entirely or not completing the lab assessment.|||mg/dL||Standard Deviation|Mean
1415999|NCT01130597|Secondary|Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline||Baseline and Day 28|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 4|||mg/g||Standard Error|Mean
1414677|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|6 months|29 out of the 215 participants in the Pharmacist CVD group and 22 out of the 213 in the Education Control group had missing cholesterol LDL at 6 months due to missing the 6 month interview entirely or not completing the lab assessment.|||mg/dL||Standard Deviation|Mean
1414678|NCT01142908|Secondary|Cholesterol LDL|Collected during interview visit by lab personnel|Baseline|4 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data due to not having cholesterol LDL collected at baseline.|||mg/dL||Standard Deviation|Mean
1414679|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|12 months|35 out of the 215 participants in the Pharmacist CVD group and 24 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 12 month assessment or non-response of adherence items collected in the 12 month interview.|||participants|||Number
1414680|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|6 months|28 out of the 215 participants in the Pharmacist CVD group and 18 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to missing the 6 month assessment or non-response of adherence items collected in the 6 month interview.|||participants|||Number
1414681|NCT01142908|Secondary|Medication Non-adherence|First 4 items of the 5 item Morisky Self-reported measure of medication adherence was used to determine medication non-adherence.|Baseline|5 out of the 215 participants in the Pharmacist CVD group and 2 out of the 213 participants in the Education Control group had missing data for medication non-adherence due to non-response of adherence items collected in the baseline interview.|||participants|||Number
1414682|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|12 months|43 out of the 215 participants in the Pharmacist CVD group and 33 of the 213 participants in the Education Control group had missing data at 12 months due to entirely missing the 12 month assessment or having missing data on one or more of the Framingham components.|||% 10 yr Risk||Standard Deviation|Mean
1414683|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and CPRS data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|6 months|29 out of the 215 participants in the Pharmacist CVD group and 24 of the 213 participants in the Education Control group had missing data at 6 months due to entirely missing the 6 month assessment or having missing data on one or more of the Framingham components.|||% 10 yr Risk||Standard Deviation|Mean
1414684|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 months due to missing the 12 month interview entirely or blood pressure not collected at the 12 mo. assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
1414685|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
1414686|NCT01142908|Secondary|Mean Diastolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.|||mmHg||Standard Deviation|Mean
1414687|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|12 months|36 out of the 215 participants in the Pharmacist CVD group and 30 out of the 213 in the Education Control group had missing blood pressure measurement at 12 mo. due to missing the 12 month interview entirely or blood pressure not collected at the 12 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
1414688|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|6 months|28 out of the 215 participants in the Pharmacist CVD group and 23 out of the 213 in the Education Control group had missing blood pressure measurement at 6 months due to missing the 6 month interview entirely or blood pressure not collected at the 6 month assessment due to patient arm size exceeding cuff size or interview completed over the phone.|||mmHg||Standard Deviation|Mean
1414689|NCT01142908|Secondary|Mean Systolic Blood Pressure|Mean BP is calculated as the average of 3 bp measurements. Collected during BP outcome measurement conducted at interviews|Baseline|One out of the 215 participants in the Pharmacist CVD group did not have blood pressure collected at baseline.|||mmHg||Standard Deviation|Mean
1414716|NCT01142596|Primary|Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52|The percentage of participants with abnormal ECG findings is reported for three time points: 6-week double-blind study P06124 baseline, extension study P06125 baseline and extension study Week 52.|Study P06124 baseline and P06125 study baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug|||percentage of participants|||Number
1414690|NCT01142908|Primary|Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent)|"Components of the Framingham include gender, age fixed at baseline, systolic blood pressure (presence/absence of blood pressure medications at each time point [combination of administrative med data pull and self-report at assessment]), total cholesterol, HDL cholesterol, smoking status (assessed via self-report at each study survey), and diabetes (diabetes is a combination of self-report and VA Computerized Patient Record System (CPRS) data review). New cases of diabetes are allowed to be updated at 6 and 12 months f/u."|Baseline|Two out of the 215 participants in the Pharmacist CVD group had missing data due to not having the blood pressure component of the Framingham collected at baseline.|||% 10 yr Risk||Standard Deviation|Mean
1414691|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Re-exposure Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Start of re-exposure period to 56 days post last dose, up to Month 30|All treated participants entering the Re-exposure Period and having measurements available were analyzed. n=evaluable. Treatment groups represent Treatment received during Treatment Period.|||participants|||Number
1414692|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality in Withdrawal Period|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Criteria for marked abnormality on laboratory test results: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase (GGT) (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of study drug in the Treatment Period, entered the Withdrawal Period, and had values available. n=number evaluable|||participants|||Number
1414693|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Re-exposure Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.|First dose in Re-exposure period up to last dose of Re-exposure Period + 56 days|Includes data up to 56 days post the last dosing day (active abatacept or active MTX, whichever is the later) in the Re-exposure Period. Treatment groups represent Treatment received during Treatment Period.|||participants|||Number
1414694|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Withdrawal Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AEs of special interest are events potentially associated with the drug or disease under study. Includes events with an onset date on or after 57 days post last dosing day (active abatacept or active MTX whichever is the later) in the Treatment Period and up to end of Withdrawal Period. Treatment groups represent treatment received during the Treatment Period.|Last dose in TP + 57 days, up to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period and entered the Withdrawal Period. Treatment groups represent treatment during the TP.|||participants|||Number
1414695|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) and Discontinuations Due to AEs During the Full Study (All Periods)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Includes data up to last active dose date +56 days if the participant discontinued the Treatment Period or did not enter the Withdrawal Period, up to the day of discontinuation in the Withdrawal Period for participants discontinuing the Withdrawal Period without entering the Re-exposure Period (RP), up to Day 729 visit (Month 24) for participants who complete the Withdrawal Period, and up to 56 days post last active dose in Re-exposure Period for participants entering the Re-exposure Period.|Day 1 to 56 days post last dose in the study, up to Month 30|All randomized participants who received at least 1 dose of study medication were analyzed.|||participants|||Number
1414748|NCT01142336|Primary|Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year|CSF Aβ42 concentration were measured at baseline and after 1-year intervention.|1-year change of CSF Aβ42 from baseline|"In the Placebo group, 1 participant was dropped due to AE and 1 was lost to follow-up.~In the Simvastatin group, 1 participant was dropped due to AE. These 3 participants were not included in the primary analysis per analysis plan.~All these 3 subjects were not included in the primary analysis based on our per protocol analysis plan."|||1-yr change, pg/ml||Standard Deviation|Mean
1414696|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) Over Time in Treatment Period and Withdrawal Period|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity. Percent=number with remission/number evaluated (ITT)|Randomization to Month 24|ITT analysis population: Included all randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Participants were grouped according to the treatment regimen to which they were randomized.N= number evaluated.|||percentage of participants||95% Confidence Interval|Number
1414697|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time During Withdrawal Period- Treated Participants in Remission at Month 12|WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.). Percentage= number of participants with remission divided by number of participants who were analyzed (all treated participants who were in remission at end of treatment period and entered the Withdrawal Period)|End of Treatment Period (Month 12) to End of Withdrawal Period (Month 24)|Treated participants who were in remission at Month 12 (DAS28-CRP<2.6) and entered the Withdrawal Period were analyzed.( N=number of participants analyzed).|||percentage of participants||95% Confidence Interval|Number
1414698|NCT01142726|Secondary|Number of Participants With Results on Hematology and Clinical Laboratory Tests Meeting the Criteria for Marked Abnormality During Treatment Period|Lower limit of normal (LLN); Upper limit of normal (ULN); Pretreatment (preRX). Criteria for marked abnormality: Platelet count (*10^9 c/µL) <0.67*LLN or >1.5*ULN, or if preRX<LLN, use 0.5*preRX and <100,000/mm^3; potassium, serum (mEq) <0.9*LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN; blood urea nitrogen (mg/dL) >2*preRX; creatinine (mg/dL) >1.5*preRX; ALT (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; AST (U/L) >3*ULN, or if preRX>ULN, use >4*preRX; ALP (U/L) >2*ULN, or if preRX>ULN, use >3*preRX; G-glutamyl transferase U/L) >2*ULN, or if preRX>ULN, use >3*preRX; glucose, fasting (mg/dL) <0.8*LLN or >1.5*ULN, or if preRX<LLN use <0.8*preRX or >ULN if preRX >ULN, use >2.0*preRX or OR <LLN; glucose, serum (mg/dL) <65 or >220; uric acid (mg/dL)>1.5*ULN, or if preRX, use >2*preRX; albumin (g/dL) <0.9*LLN, or if preRX<LLN, use <0.75*preRX; hemoglobin (g/dL)>3 decrease from preRX; hematocrit (%) < 0.75*preRX.|Day 1 up to 56 days following the last dosing day in the Treatment Period (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Participants|||Number
1414699|NCT01142726|Secondary|Adverse Events (AEs) of Interest During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. AEs of special interest are events potentially associated with the drug or disease under study.|Day 1 to 56 days following last dosing day (Day 365)|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period|||Participants|||Number
1414700|NCT01142726|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Related Adverse Events (AEs), and Discontinuations Due to AEs During the Treatment Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to up to 56 days following the last dosing day (Day 365); all deaths during study period, including those that occurred >56 days after last dose in Treatment Period|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period|||Participants|||Number
1414701|NCT01142726|Secondary|Adjusted Mean Change From Baseline Over Time in Findings on Magnetic Resonance Imaging (MRI)|TP=treatment period; WP=withdrawal period. Change from Baseline=Postbaseline-baseline value. MRI was used to assess joint damage progression at Months 6, 12, and 18. If >20% of joints with a missing score for a parameter (erosion, osteitis, and synovitis), the MRI score of each parameter was considered missing. If ≤20% of joints had a missing score for a parameter, the MRI score for that parameter from the missing joints was carried forward from the previous MRI assessment, or carried backward from the next MRI assessment, if missing score occurred at baseline. MRI total score ranged from 0 (best outcome) to 4 (worst outcome). A gadolinium-enhanced MRI of the dominant hand-wrist was performed on all randomized patients at 5 points. The hand/wrist assessed to have more synovitis was selected initially and used for all subsequent evaluations. The MRI examination was standardized to ensure sufficient image quality for the evaluation of radiographic progression of rheumatoid arthritis.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=the number of patients with both baseline and postbaseline measurements.|||Units on a scale||Standard Error|Mean
1416000|NCT01130597|Secondary|Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day||56 Days||||percentage of participants|||Number
1414702|NCT01142726|Secondary|Adjusted Mean Change From Baseline at Months 6, 12, and 18 in Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores of Short Form-36 (SF-36)|TP=treatment period; WP=withdrawal period. The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.|Randomization to Months 6, 12, and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Units on a scale||Standard Error|Mean
1414703|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Over Time|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Units on a scale||Standard Error|Mean
1414704|NCT01142726|Secondary|Percentage of Participants Achieving a Health Assessment Questionnaire (HAQ) Response Over Time|HAQ response defined as a reduction of at least 0.3 units from baseline in score on the Health Assessment Questionnaire Disability Index (HAQ-DI), which assesses patients' functional ability by rating their abilities over the previous week. The HAQ-DI includes at least 2 questions from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. When aids, devices, or help is indicated by the patient, the score for the category item is raised from a 0 or a 1 to a 2, but if the patient's highest score for a subcategory is a 3, it stays a 3.|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1414705|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Scores on Simplified Disease Activity Index (SDAI) Over Time|TP=treatment period; WP=withdrawal period. The SDAI is the simple linear sum of 5 outcome parameters: swollen joint count (SJC) and tender joint count (TJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SJC is assessed and recorded at each visit, with no swelling=0, swelling=1 (higher score indicates greater swelling). TJC is assessed at each visit through identification of joints that are painful under pressure or to passive motion, with no tenderness=0, tenderness=1 (higher score indicates greater affection due to disease activity)..|Randomization to Month 18|Intent to Treat (ITT) population. n= number of participants with both post baseline and baseline measurements.|||Units on a scale||Standard Error|Mean
1414706|NCT01142726|Secondary|Percentage of Participants Who Achieved Remission by Criteria of the Simplified Disease Activity Index (SDAI) at Months 12 and 18|TP=treatment period; WP=withdrawal period. SDAI-defined remission= ≤3.3. The SDAI is the simple linear sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) (based on a 28-joint assessment); patient's and physician's global assessments of disease activity (assessed on 0-10 cm visual analog scale, on which higher scores=greater affection due to disease activity); and C-reactive protein level (mg/dL). SDAI total score=0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high disease activity. TJC is assessed and recorded at each visit, with no swelling=0, swelling=1. SJC is assessed through identification of joints that are painful under pressure or to passive motion. TJC is recorded on the joint assessment form at each visit, with no tenderness =0, tenderness = 1. Higher score indicates greater affection due to disease activity.|Randomization to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Months 12 and 18, and b=number of patients in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1414707|NCT01142726|Secondary|Adjusted Mean Change From Baseline in Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) at Months 6, 12, and 18|TP=treatment period; WP=withdrawal period. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Baseline to Month 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. n=number evaluable|||Units on a scale||Standard Error|Mean
1414769|NCT01142115|Secondary|Visible Blood|"Visual blood observed on the catheter or in the urine in connection to catheterization.~The nurse who conducted the catheterization could answer yes or no as follows:~Yes = visible blood observed. No = no visible blood observed."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||participants|||Number
1416001|NCT01130597|Secondary|Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)||56 Days||||percentage of participants|||Number
1414708|NCT01142726|Secondary|Percentage of Participants With Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria Over Time - Intent to Treat Population|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Month 24|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Day x, and b=number of patients in the analysis (intent to treat).|||Percentage of participants||95% Confidence Interval|Number
1414709|NCT01142726|Secondary|Percentage of Participants Who Received Monotherapy and Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|TP=treatment period; WP=withdrawal period. Remission defined as DAS28-CRP<2.6. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). DAS-CRP scores range from 0 to 10, with higher values indicating greater disease activity. Individual measures are fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind monotherapy in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable|||Percentage of participants||95% Confidence Interval|Number
1414710|NCT01142726|Primary|Percentage of Participants Who Achieved Remission by Disease Activity Score 28 Based on C-reactive Protein (DAS28-CRP) Criteria at Month 12 and at Both Months 12 and 18|DAS28-CRP remission defined as <2.6; TP=treatment phase; WP=withdrawal phase. The DAS 28-CRP is a measure of disease activity in rheumatoid arthritis (RA) that assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS (a score greater than 5.1 implies active disease; less than 3.2, well controlled disease; and less than 2.6, remission.)|Randomization to Months 12 and 18|All randomized participants who received at least 1 dose of double-blind study medication in the Treatment Period. Percentage calculated as a/b, where a=number of patients who achieved remission at Month 12 and at both Months 12 and 18, and b=number of patients in the analysis. n=number evaluable|||Percentage of participants|||Number
1414711|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with serious adverse events for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months||||participants|||Number
1414712|NCT01142661|Primary|Safety|General safety will be assessed by monitoring and recording the number of patients with adverse events (serious and nonserious) for duration of treatment which continued until disease progression, unacceptable toxicity or death.|For duration of treatment, an average of 5 months||||participants|||Number
1414713|NCT01142596|Primary|Median Time to Loss of Effect in Non-Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Non-Responders, participants without ≥30% decrease from study P06124 baseline in PANSS Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant’s schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Non-Responders|||days||95% Confidence Interval|Median
1414714|NCT01142596|Primary|Median Time to Loss of Effect in Responders|Median time to loss of effect from P06125 extension study baseline was estimated using Kaplan-Meier product-limit method. Result reported in Responders, participants with ≥30% decrease from study P06124 baseline in Positive and Negative Syndrome Scale (PANSS, schizophrenia symptom scale) Total Score at the end of study P06124. Investigator or subinvestigator was to determine whether the study drug failed to maintain effect based on occurrence of any of the following: 1) Increase in PANSS Total Score ≥30% from P06125 extension study baseline, 2) Determination that participant’s schizophrenic symptomatology had deteriorated requiring one or more of defined interventions (add new antipsychotic drug, increase in level of psychiatric outpatient care, or hospitalization/increase in level of hospitalization for psychiatric need), 3) Clinical Global Impression-Severity (CGI-S) score ≥6, 4) Discontinuation from study because of lack of efficacy, 5) AE/SAE of worsening of schizophrenia.|P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, had PANSS measurement at P06125 baseline and at least one post-baseline PANSS measurement, and were study P06124 Responders|||days||95% Confidence Interval|Median
1414715|NCT01142596|Primary|Number of Participants Who Took Antiparkinsonian Drugs|This measure presents the number of participants who used antiparkinsonian drugs started on or after the start of study treatment in extension study P06125. Antiparkinsonian drugs were defined as those categorized into the N04 code (antiparkinson drugs) of the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification system.|P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
1414717|NCT01142596|Primary|Number of Participants With Non-serious AEs|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. This measure presents the number of participants with at least one AEs that was non-serious (i.e., was not determined to be an SAE).|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
1414718|NCT01142596|Primary|Number of Participants With Serious Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with study drug administration, whether or not considered related to study drug. A serious AE (SAE) is any AE occurring at any dose that results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In addition, an important medical event that may not result in death, be life-threatening, or require hospitalization may be considered an SAE when it may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
1414719|NCT01142596|Primary|Change From Study P06125 Baseline in Prolactin at Week 52|For each participant, change in prolactin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||μg/L||Standard Deviation|Mean
1414720|NCT01142596|Primary|Change From Study P06124 Baseline in Prolactin at Week 52|For each participant, change in prolactin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||μg/L||Standard Deviation|Mean
1414721|NCT01142596|Primary|Change From Study P06125 Baseline in Insulin at Week 52|For each participant, change in insulin from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||μIU/mL||Standard Deviation|Mean
1414722|NCT01142596|Primary|Change From Study P06124 Baseline in Insulin at Week 52|For each participant, change in insulin from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||μIU/mL||Standard Deviation|Mean
1414723|NCT01142596|Primary|Change From Study P06125 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||mmol/L||Standard Deviation|Mean
1414724|NCT01142596|Primary|Change From Study P06124 Baseline in Fasting Glucose at Week 52|For each participant, change in fasting glucose from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||mmol/L||Standard Deviation|Mean
1414725|NCT01142596|Primary|Change From Study P06125 Baseline in HbA1c at Week 52|For each participant, change in HbA1c from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||percentage of HbA1c||Standard Deviation|Mean
1414726|NCT01142596|Primary|Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|For each participant, change in HbA1c from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||percentage of HbA1c||Standard Deviation|Mean
1414727|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment|||score on a scale||Standard Deviation|Mean
1414788|NCT01141712|Secondary|Hematologic Function|Hematologic function will be defined as ANC > 1500 neutrophils/μL, Hemoglobin> 10g/dL without transfusion support, and platelets > 100,000/μL|Days 100 and 365||||participants|||Number
1414728|NCT01142596|Primary|Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint|Change in DIEPSS Item 9 (Global) Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Each item is rated from 0 (none, normal) to 4 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment|||score on a scale||Standard Deviation|Mean
1414729|NCT01142596|Primary|Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint|Change in DIEPSS Total Score from extension study P06125 baseline to the endpoint assessment of extension study was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and endpoint assessment|||score on a scale||Standard Deviation|Mean
1414730|NCT01142596|Primary|Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint|Change in DIEPSS Total Score from preceding 6-week double-blind Study P06124 baseline to endpoint assessment of extension study P06125 was determined (calculated as endpoint value minus baseline value). Endpoint assessment was last evaluation of participant for this measure in study, whether participant completed or did not complete study. DIEPSS is a scale, rated by the investigator or rater appointed by the investigator, used to evaluate the severity of drug induced extrapyramidal symptoms occurring during antipsychotic drug treatment. It consists of 9 items: Items 1 through 8 assess individual symptoms; Item 9 is an assessment of global severity. Items 1 through 8 are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Each item is rated from 0 (none, normal) to 4 (severe). The Total Score is the sum of scores on Items 1 through 8, with a range from 0 (normal) to 32 (severe). Negative values of change from baseline represent improvement in symptoms.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 endpoint assessment|||score on a scale||Standard Deviation|Mean
1414731|NCT01142596|Primary|Number of Participants With Extrapyramidal Symptoms|This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for “extrapyramidal syndrome” were treated as extrapyramidal symptoms.|Up to 30 days after last dose of study drug (Up to approximately 56 weeks)|All participants randomized in study P06125 who received at least one dose of study drug|||participants|||Number
1414732|NCT01142596|Primary|Change From Study P06125 Baseline in BMI at Week 52|For each participant, change in BMI from extension study P06125 baseline to Week 52 of extension study was determined (calculated as Week 52 value minus baseline value).|Study P06125 baseline and Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and Week 52|||kg/m^2||Standard Deviation|Mean
1414733|NCT01142596|Primary|Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52|For each participant, change in BMI from preceding 6-week double-blind Study P06124 baseline to Week 52 of extension study P06125 was determined (calculated as Week 52 value minus baseline value).|Study P06124 baseline and study P06125 Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 Week 52|||kg/m^2||Standard Deviation|Mean
1414734|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment|For each participant, change in weight from extension study P06125 baseline to the final assessment of extension study was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06125 baseline up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06125 baseline and final assessment|||percentage of participants in category|||Number
1414735|NCT01142596|Primary|Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment|For each participant, change in weight from preceding 6-week double-blind Study P06124 baseline to the final assessment of extension study P06125 was determined (calculated as final assessment value minus baseline value). Final assessment was last evaluation of participant in study, whether participant completed or did not complete study. Participants were allocated to categories of percentage change from defined baseline to final assessment.|Study P06124 baseline and P06125 study from Day 1 up to Week 52|All participants randomized in study P06125 who received at least one dose of study drug, and had data for measure at study P06124 baseline and study P06125 final assessment|||percentage of participants in category|||Number
1414789|NCT01141712|Secondary|Cumulative Incidence of Platelet Recovery|Platelet recovery is defined as a platelet count greater than 20,000/μL for the first of two consecutive labs with no platelet transfusions 7 days prior.|Day 100||||percentage of participants||95% Confidence Interval|Number
1414736|NCT01142466|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Baseline to Week 96|Safety population included all participants all randomized participants of the active treatment group who received at least 1 injection and all randomized participants of the ‘No Treatment’ group, provided that any post-baseline data was available.|||participants|||Number
1414737|NCT01142466|Secondary|Mean Changes in Expanded Disability Status Scale (EDSS) Score From Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5.|Baseline to Week 12, 24, 36, 48, 60, 72, 84, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||Units on a Scale||Standard Deviation|Mean
1414738|NCT01142466|Secondary|Absolute Changes in the Number of T2 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T2 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||T2 lesions||Standard Deviation|Mean
1414739|NCT01142466|Secondary|Absolute Changes in the Number of T1-Gadolinium (T1-Gd) Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1-Gadolinium enhancing lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|The data was not evaluated due to the small sample size available for this parameter.||||||
1414740|NCT01142466|Secondary|Absolute Changes in the Number of T1 Lesions From Baseline to Week 24, 48, 72 and 96|Analysis of T1 lesions was done using magnetic resonance imaging (MRI) scans.|Baseline to Week 24, 48, 72, and 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.|||T1 lesions||Standard Deviation|Mean
1414741|NCT01142466|Secondary|Number of Relapse-free Participants|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|ITT population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment.|||participants|||Number
1414742|NCT01142466|Primary|Time From Baseline to First Multiple Sclerosis Relapse (in Weeks)|A qualifying relapse was defined as a new or worsening neurological symptom, in the absence of fever, lasting for >= 48 hours, and accompanied by an objective change in the relevant (i.e. symptomatic) Kurtzke Functional Systems (KFS).|Baseline through Week 96|Intent-to-treat (ITT) population included all participants who received at least 1 treatment dose (only for Rebif group) and had at least 1 post-baseline efficacy endpoint assessment. Time to relapse was documented for participants who had at least 1 relapse during the study period.|||weeks||Standard Deviation|Mean
1414743|NCT01142388|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible patients. Responses are evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|assessed every 8 weeks while on treatment and every 3 months after treatment for 2 years|Eligible patients|||percentage of participants||90% Confidence Interval|Number
1414744|NCT01142388|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization until death (event), or censored at last date known alive. OS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood’s formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients|||months||90% Confidence Interval|Median
1414745|NCT01142388|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. For cases without documentation of progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (4 months) following the date last known progression-free, in which case the death was counted as an event, or in the case of death within 4 months of randomization in the absence of disease evaluation before that time. PFS was estimated using the Kaplan-Meier method, with 90% confidence intervals calculated using Greenwood’s formula, and compared by the log rank test.|assessed every 3 months for 2 years after registration|Eligible patients.|||months||90% Confidence Interval|Median
1414746|NCT01142336|Primary|Change From Baseline in CSF ptau181 at 1 Year|ptau 181 measured in CSF at baseline and after 1-year intervention|1-year change from baseline||||1-yr change (final - baseline), pg/ml||Standard Deviation|Mean
1414747|NCT01142336|Primary|Change From Baseline in CSF Total Tau at 1 Year|CSF total tau was measured at baseline and after 1-year of intervention|1-yr change|"In the Placebo group, 1 participant was dropped due to AE and 1 was lost to follow-up.~In the Simvastatin group, 1 participant was dropped due to AE. These 3 participants were not included in the primary analysis per analysis plan.~All these 3 subjects were not included in the primary analysis based on our per protocol analysis plan."|||pg/ml||Standard Deviation|Mean
1414790|NCT01141712|Secondary|Cumulative Incidence of Neutrophil Recovery|Neutrophil recovery is defined as two consecutive days of absolute neutrophil count (ANC) > 500 neutrophils/μL following the expected nadir.|Day 28||||percentage of participants||95% Confidence Interval|Number
1414749|NCT01142323|Secondary|Mayo Risk Score for Primary Sclerosing Cholangitis|"The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score.~MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values).~Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk.~There is no known range for this score."|6 months|Median baseline MRS was compared to Median MRS after 6 months of study drug|||score||Full Range|Median
1414750|NCT01142323|Primary|Serum Alkaline Phosphatase|Serum alkaline phosphatase will be measured at entry and end of study|6 months||||U/L||Standard Error|Median
1414751|NCT01142310|Primary|The Rey Auditory Verbal Learning Test (RAVLT)|The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. A higher score reflects better performance.|48 weeks||||T Score||Standard Deviation|Mean
1414752|NCT01142297|Secondary|Clinical Success of Implants||1 year|Data were not collected||||||
1414753|NCT01142297|Primary|Implant Stability Quotient (ISQ)|resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.|4 months||||units on a scale||Standard Error|Mean
1414754|NCT01142193|Secondary|Proportion of Subjects ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.|||Percentage of participants|||Number
1414755|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.|||Percent Reduction||Full Range|Median
1414756|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Maintenance Phase Compared to Baseline.||8 weeks (weeks 4-11)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug. Note: Sample size is less than for primary outcome because some subjects discontinued study prior to the maintenance phase.|||Percentage of participants|||Number
1414757|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percentage of participants|||Number
1414758|NCT01142193|Secondary|Proportion of Subjects With ≥25%, ≥75%, and 100% Reduction in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phases Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percentage of participants|||Number
1414759|NCT01142193|Secondary|Percent Reduction From Baseline in Weekly (7 Day) All Seizure Frequency During the Titration Plus Maintenance Phase.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percent Reduction||Full Range|Median
1414760|NCT01142193|Secondary|Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percent Reduction||Full Range|Median
1414761|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.||3 weeks (weeks 1-3)||||Percentage of participants|||Number
1414762|NCT01142193|Secondary|Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percentage of participants|||Number
1414763|NCT01142193|Primary|Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.||11 weeks|Intent-to-treat (ITT): all subjects who were randomized and received at least 1 dose of study drug|||Percent Reduction||Full Range|Median
1414764|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
1414765|NCT01142128|Primary|Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
1414766|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Placebo to Nexium|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
1414767|NCT01142128|Primary|Reduction of Abdominal Pain for Participants Taking Nexium Alone.|To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain|4 months|Analysis was not able to be done due to the small sample size.||||||
1414768|NCT01142115|Secondary|Haematuria|"Negative or positive result on a multistix urin analysis.~Negative haematuria: 10 erythrocytes/microliter or less. Positive haematuria: above 10 erythrocytes/microliter."|2 hours after catheterisation at visits 1 and 2|ITT|||participants|||Number
1414770|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Withdrawal Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter withdrawal had been.~There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||participants|||Number
1414771|NCT01142115|Secondary|Ease of Use Measured on a 5 Point Scale: Insertion Effort|"After each catheterization the nurse who conducted the catheterization answered how the catheter insertion had been.~There were 5 answer categories: very difficult - difficult - neither easy nor difficult - easy - very easy"|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||participants|||Number
1414772|NCT01142115|Secondary|Irritation During Voiding After Catheterization|"After each catheterization subjects were asked if they felt any irritation during voiding with answer option yes or no.~Yes - they experienced irritation. No - they did not experience irritation."|10 minutes after each catheterization at visit 1 and at visit 2, which is 5-25 days after visit 1|ITT|||Participants|||Number
1414773|NCT01142115|Primary|Discomfort Measured on the Visual Analog Scale (VAS)|"Outcome measured on a 10 cm Visual Analog Scale ranging from no discomfort (0cm) to worst thinkable discomfort (10cm)."|10 minutes after each catheterisation at visit 1 and at visit 2 which is 5-25 days after visit 1|Intention to Treat (ITT) population|||cm||Standard Deviation|Mean
1414774|NCT01142089|Secondary|Clinical Cure|"Clinical Cure is defined as either of the following:~Passage of two or fewer soft stools and no watery stools, no fever (>100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24 hour interval in the 120-hr data collection period after the first dose of study drug~Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hr data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection"|24 hours|Intent to treat (ITT)|||Participants|||Count of Participants
1414775|NCT01142089|Primary|Time to Last Unformed Stool (TLUS)|"The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner:~Step 1: Identify when the patient achieves Clinical Cure.~Step 2: Moving backwards from this time, identify the time of the last unformed stool.~Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2."|24 hours|"Intent To Treat (ITT). Please note that the 75th percentile was not observed during the 120-hour study period for placebo patients.~The percentile groups indicate the hour at which the appropriate percentage of the patient group had met the primary endpoint i.e. by 72 hours, 75% of Rifamycin SV MMX patients had met the endpoint."|||TLUS (hours)||95% Confidence Interval|Mean
1414776|NCT01141725|Secondary|Disease-free Survival (DFS)|In a five year following, the disease free survival was obtained.|5 years|Data for this Outcome Measure was not collected per dose level and is unavailable.|||days||95% Confidence Interval|Median
1414777|NCT01141725|Primary|Median Survival|In a five year following, the median survival was obtained.|5 years||||months||Full Range|Median
1414778|NCT01141725|Primary|Maximum Tolerated Dose|A bayesian approach to estimate the MTD of bendamustine associated with a CR rate of at least 40% and with <30% grade 3–4 non-haematological toxicity was used (Wathen et al, 2008).The MTD of bendamustine in combination with idarubicin was determined after two cases of grade 3 toxicity were noted in the three patients entered at the 75 mg/m2 dose. The DLTs were congestive heart failure and mucositis in one patient each. Patients subsequent to this were treated at the 60 mg/m2 bendamustine dose.|6 months||||mg/m2|||Number
1414779|NCT01141725|Primary|Incidence of Greater Than or Equal to Grade 3 Toxicity|Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0.|Up to day +100 after end of therapy or until the patient received an alternative treatment for leukemia, whatever happens earlier||||Participants|||Count of Participants
1414780|NCT01141725|Primary|Response|Assessed by cytogenetics/fluorescence in situ hybridization (FISH) and flow cytometry of blood and bone marrow samples. The response criteria defined by Cheson et al. will be used in this study. These criteria are: morphologic leukemia-free state; morphologic complete remission (CR); cytogenetic CR (CRc); molecular CR (CRm); morphologic CR with incomplete blood count recovery (CRi); partial remission (PR); treatment failure; recurrence (progressive disease).|6 months||||Participants|||Count of Participants
1414781|NCT01141712|Secondary|Ig and Epstein-Barr Virus (EBV) DNA in Blood|The presence of clonal Ig DNA in plasma will be assessed, as will EBV copy number in plasma and in peripheral blood|Day 100, 180, and 365|No data collected to analyze this outcome measure.||||||
1414782|NCT01141712|Secondary|Microbial Translocation Markers|Level of microbial translocation markers will be determined by nonparametric Mann-Whitney tests comparing the distribution of prior microbial translocation markers between patients.|Day 30 and 100|No data collected to analyze this outcome measure.||||||
1414783|NCT01141712|Secondary|HIV Single-Copy Polymerase Chain Reaction (PCR)|HIV RNA assay will be performed at the specified time points and summarize the assessments of the viral copy number using descriptive statistics.|Baseline, Days 100, 180, 365, and 730|Participants with an undetectable (<50 copies/mL) viral load are not included in this analysis (Baseline = 32, Day 100 = 19, Day 180 = 20, Day 365 = 19, and Day 730 = 21)|||copies/mL||Full Range|Median
1414784|NCT01141712|Secondary|Immunologic Reconstitution|Immunologic Reconstitution will be assessed by quantitative immunoglobulin measurement (IgM, IgG and IgA)|Year 1||||mg/dL||Full Range|Median
1414785|NCT01141712|Secondary|Treatment-Related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression. A cumulative incidence curve will be computed along with a 95% confidence interval at 100 days post-transplant.|Day 100||||percentage of participants||95% Confidence Interval|Number
1414786|NCT01141712|Secondary|Number of Participants Experiencing Infections|Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any.|Year 1||||participants|||Number
1414787|NCT01141712|Secondary|Number of Participants Experiencing Toxicity|Toxicities will be defined by using the version 3.0 NCI Common Terminology Criteria for Adverse Events (CTCAE) criteria. Only grade 3 and higher toxicities will be collected.|Year 2||||participants|||Number
1414791|NCT01141712|Secondary|Lymphoma Disease-free Survival|This will be assessed in patients with CR. Patients are considered failure for this end point if they die or if they relapse after complete remission. Patients with no history of relapse or death after complete remission are censored at time of last follow up.|Year 2|No data collected to analyze this outcome measure.||||||
1414792|NCT01141712|Secondary|Time to Progression After CR|This will be assessed in patients with CR. Patients are considered failure for this end point if they relapse after complete remission. Surviving patients with no history of relapse/progression are censored at time of last follow-up.|Year 2|No data collected to analyze this outcome measure||||||
1414793|NCT01141712|Secondary|Complete Remission (CR) and/or Partial Response (PR)|The frequencies and proportions of patients who have a CR or PR. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease and no new sites.|Day 100|One participant died at day 64 and was not included in analysis|||participants|||Number
1414794|NCT01141712|Secondary|Progression-Free Survival (PFS)|The time to this event is the time from enrollment until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first. Progression-free survival (PFS) will be estimated using the Kaplan Meier product limit estimator. The PFS probability and confidence interval will be calculated at two years post-transplant.|Year 2||||percentage of participants||95% Confidence Interval|Number
1414795|NCT01141712|Secondary|Relapse/Progression|Relapse is defined as the appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. Progression is defined as a lymph node with a diameter of the short axis of less than 1.0 cm must increase by >= 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.|Year 2||||percentage of participants||95% Confidence Interval|Number
1414796|NCT01141712|Primary|Overall Survival (OS)|Assess the OS after autologous hematopoietic stem cell transplantation (HCT) for chemotherapy-sensitive aggressive B cell lymphoma or Hodgkin's lymphoma in patients with HIV using BEAM for pre-transplant conditioning. The primary analysis will consist of estimating the 1 year OS probability from the time of transplantation based on the Kaplan-Meier product limit estimator. The 1 year and 2 year OS and confidence interval will be calculated.|Year 1 and 2||||percentage of participants||95% Confidence Interval|Number
1414797|NCT01141660|Secondary|Postanesthesia Recovery Times||After surgery||||minutes||Standard Deviation|Mean
1414798|NCT01141660|Primary|Number of Participants With Laryngospasm||2 years||||Participants|||Number
1414799|NCT01141647|Secondary|Determine Cost-effectiveness.|QALYs are the mean quality adjusted life years per patient for the Supported Employment and Standard Care groups. The QALY is a non-negative number assessing the quality and length of life and not just the crude number of years. The minimum value is 0 representing no improvement in the quality of life or length of life and larger numbers indicate healthier and longer life. Maximum QALYs are limited only by the life span of study participants, but may not exceed 1 (perfect health) in any given year.|24-month phase with face-to-face quarterly interviews|213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.|||years||Standard Deviation|Mean
1414800|NCT01141647|Secondary|Determine Total Cost Per Patient Over 24 Months|Total cost is the mean total cost per patient over 24 months in US dollars. The minimum value is 0 representing no cost in US dollars and larger numbers indicating higher costs in US dollars.|24-month phase with face-to-face quarterly interviews|213 SE participants in the PrOMOTE study were compared to 76 individuals in the control group of the SCI-VIP study.|||US dollars||Standard Deviation|Mean
1414801|NCT01141647|Secondary|Evaluate the Effectiveness of Implementation Strategy and Level of SE Model Implementation Across Sites.|Level of implementation was assessed by interviewing clinical and vocational providers from the seven sites who were involved in or knowledgeable about the program. Values reported represent the numbers of clinical staff who cited having the VRS integrated on the clinical team, a full-time VRS, leadership support, engagement of staff, resources provided immediately, making adjustments to the implementation to fit with the local context, and having audit and feedback as supporting strong implementation|24-month phase with face-to-face quarterly interviews|Each stage comprised of two site visits. Please note that in the early stage fit of IPS model and audit and feedback were not assessed in either of the site visits, hence a value of zero is entered. Also note that in the late stage obtaining resources, fit of IPS model, and audit and feedback were only assessed at 1/2 of the site visits.|||participants|||Number
1414802|NCT01141647|Secondary|Determine Ongoing Effectiveness of SE Over Time.|This measure is used to evaluate the participants who were both in SCI-VIP and PrOMOTE. It assesses the number of people who obtained CE in SCI-VIP and sustained the same CE through their time in the PrOMOTE study. The cohort of SCI-VIP SE participants in PrOMOTE were analyzed separately from the 213 PrOMOTE participants.|48-month phase with face-to-face quarterly interviews|Number of participants in 24-month SE and 24-month SCI-VIP (previous study).|||participants|||Number
1414803|NCT01141647|Secondary|Employment Rate|Competitive Employment (CE) rate for individuals who participated in the Supported Employment arm of the PrOMOTE Study.|24 Months||||percentage of participants with CE|||Number
1414804|NCT01141647|Primary|Identify Factors That Predict Employment After SCI.|To model the probability of obtaining CE, we first dichotomized CE as 'yes' or 'no'. The Competitive Employment Rate is reported in Outcome Measure 2. We then used unconditional logistic regression to model the probability of obtaining CE through a univariate modeling approach to determine statistically significant predictors of CE. Statistically significant predictors at the p<0.10 criterion level were then explored in a final multivariate model. Demographic (age, race, marital status, etc.), clinical (severity of injury, comorbidities, time since injury, etc.), barriers and facilitators, and quality of life (depression, Satisfaction with Life, etc.) were considered for modeling. A final model was obtained by including all parameters meeting the p<0.10 criterion into a final multivariate model.|24-month phase with face-to-face quarterly interviews||||Odds Ratio||90% Confidence Interval|Number
1414805|NCT01141595|Primary|Preschool Language Scales|Change in the raw score from baseline of the Preschool Language Scales over the 16 week period. The raw score was measured at baseline, 8 weeks and 16 weeks after starting treatment and the change over the 16 week period from baseline to the end of the study was calculated. There was no imputed data and the analysis was as treated. The raw score ranged from 0 to 130. Higher scores indicate better performance.|16 weeks|The number of participants with data available that completed at least the 16 week assessment.|||Raw score units / 16 weeks||Standard Deviation|Mean
1414808|NCT01141569|Secondary|Progression-free Survival Rate|Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 12 months||||months||95% Confidence Interval|Median
1414809|NCT01141569|Secondary|Frequency and Severity of Adverse Events|Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.|Up to 12 months|Number analyzed is number of participants who experienced the adverse event.|||Participants|||Count of Participants
1414810|NCT01141569|Secondary|Time to Progression|Time to Progression is duration of time from start of treatment to time of progression|Up to 12 months||||months||95% Confidence Interval|Median
1414811|NCT01141569|Primary|Objective Response Rate (PR + CR) Using RECIST|"Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters"|Up to 12 months|Patients that had PR or CR (Objective response)|||participants|||Number
1414812|NCT01141491|Secondary|Overall Survival|To compare the overall survival over time, to estimate the median and 3-year progression-free survival.|Measured over time||2017-04-30|04/2017||||
1414813|NCT01141491|Primary|Progression Free Survival|"The primary objective is to compare the progression-free survival (PFS) over time.~Progression free survival is defined as the time from randomization until any evidence of tumor growth or appearance anywhere in the body or death from any cause as determined by the principal investigator at each site. The principal investigator will determine Progression-free survival by using CT scans to evaluate disease recurrence. For the purpose of this study, progression of disease is defined as the development of tumor growth or recurrence at any site of the body as determined by the principal investigator at each study site or death from disease"|3-years||||Days||95% Confidence Interval|Median
1414814|NCT01141374|Secondary|Stress Levels(3rd and 4th Evaluation)|Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 and 75 days|75 participants were assessed|||units on a scale||Standard Deviation|Mean
1414815|NCT01141374|Primary|Stress Levels After 4 Sessions (2nd Evaluation)|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 30 days|Of the 109 subjects, four were eliminated for having a low level of stress and 3 for not belonging to nursing staff. Of the 105, 7 didn't appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one did not complete the questionnaire, seven went on vacation or sick leave (2).|||units on a scale||Standard Deviation|Mean
1414816|NCT01141283|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|6 months.|The extension safety population consisted of all subjects who were exposed to BTDS and had at least 1 safety assessment during extension phase.|||participants|||Number
1414817|NCT01141205|Secondary|Increase in Blood CD4 T-cell Counts|Analyzed: Participants (minus drop-outs and withdrawn) with measured blood CD4 T-cell counts (cells/microliter). Reported: Numbers of participants obtaining an increase in measured blood CD4 T-cell counts post vaccination of >100 CD4 Tcell per microliter|up to 6 months post vaccination|Participants minus drop-outs and withdrawn participants|||participants with increased CD4 count|||Number
1414818|NCT01141205|Secondary|Lowering of HIV-1 RNA Viral-load in HIV-1 Immune Responders More Than 1 Log|changes (lowering) in Plasma HIV-1 RNA viral-load (measured by Quantitative RT-PCR kit, ROCHE) of more than 1 log|up to 6 months post immunization|Participants minus drop outs and participants withdrawn by them selves or by the physicians|||participants with lowering of VL|||Number
1414819|NCT01141205|Secondary|Induction of New T-cell Immune Response by the Vaccine|induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay)measuring Spot forming Unis per 1 million periferal blood mononuclear cells (SFU/1 mio PBMCs) above treshold (> 50 sfu/mio PBMC).|up to 6 months after last immunisation|Analyzed: Participants minus drop-outs and withdrawn participants. Reported: numbers of participants with a new induced ELISPOT Y-cell immune response to the vaccine peptide epitopes|||ELISPOT responders|||Number
1414820|NCT01141205|Primary|Tolerability and Safety of the Treatment.|"We report here the numbers of participants with vaccine related adverse events degree 3 or 4.~Our goal for safety and tolerability was: Fewer than or 3 patients of the 15 vaccine treated show treatment related (reaction 3) side-effects of degree 3 or 4."|up to 6 months after end of treatment|Analyzed: number of participants started minus individuals lost to follow up or participants that withdraw. Thus we include the two individuals where the physician stopped his/her participation because of SAE not related to the vaccine or to the placebo. Reported: numbers of participants with vaccina related SAE|||participants|||Number
1414821|NCT01141049|Secondary|Percent Days of Abstinence From Alcohol|During the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients.|assessed for up to 8 weeks, presented at week 8 of trial||||percent of days abstinent||Standard Deviation|Mean
1414822|NCT01141049|Primary|Percent of Heavy Drinking Days Per Week|percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week.|assesed over 8 weeks, presented for week 8 of trial||||percent of heavy drinking days||Standard Deviation|Mean
1414823|NCT01140906|Secondary|Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine|The Discontinuation-Emergent Signs and Symptoms Scale (DESS) was designed to evaluate possible effects of discontinuation of antidepressant therapy. It is a clinician-rated instrument that queries for signs and symptoms on a 43-item checklist (for example, agitation, insomnia, fatigue, and dizziness) to assess whether the item (event) is discontinuation-emergent. A new or worsened event reported after discontinuation of therapy scores 1 point on the checklist, and the DESS total score is the sum of all positive scores on the checklist. A higher score indicates more symptoms.|Change from Week 8 in DESS total score analyzed at Week 10|All Patients Completed Set (APCS), OC, Analysis of Covariance (ANCOVA)|||units on a scale||Standard Error|Mean
1414824|NCT01140906|Secondary|Change From Baseline in ASEX Total Score After 8 Weeks of Treatment|The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient self-rated scale that evaluates a patient’s recent sexual experience. Patients are asked to assess their own experience over the last week (for example, “How strong is your sex drive?”, “Are your orgasms satisfying?”) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. A negative change indicates a lower sexual dysfunction.|Baseline and Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
1414825|NCT01140906|Secondary|Change From Baseline in SDS Total Score After 8 Weeks of Treatment|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.|Baseline and Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
1414826|NCT01140906|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF, Logistic Regression|||percentage of patients|||Number
1414827|NCT01140906|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20||Baseline and Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
1414828|NCT01140906|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS, MMRM|||units on a scale||Standard Error|Mean
1414829|NCT01140906|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 8|FAS, last observation carried forward (LOCF), Logistic Regression|||percentage of patients|||Number
1414830|NCT01140906|Primary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS), mixed model for repeated measurements (MMRM)|||units on a scale||Standard Error|Mean
1414831|NCT01140880|Primary|Course Completion|PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion.|28-days post initiation|40 participants initiated PEP during the study, of which 30 had evaluable course completion data.|||participants|||Number
1414832|NCT01140880|Primary|Medication Adherence|Adherence to Truvada medication (if initiated) as assessed by self-report and pill count.|Daily throughout medication course|40 participants initiated Truvada, of which 30 had evaluable medication adherence and course completion data (the 10 others were involved in the protocol violation).|||proportion|||Number
1414833|NCT01140880|Secondary|Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)|Abstinence will be measured using thrice weekly urine drug screens and self-report|Thrice-weekly for 8 weeks|170 participants enrolled in the study, of which 30 were involved in a protocol violation that rendered their data un-analyzable. The final analytical sample is N = 140.|||Stimulant-free urinalyses||Standard Deviation|Mean
1414834|NCT01140880|Primary|Time From Exposure to Truvada Initiation|Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen.|6-month follow-up|40 participants with evaluable data initiated Truvada during the course of the study.|||hours||Standard Deviation|Mean
1414835|NCT01140867|Secondary|QoL-QOLIE31 (Quality of Life in Epilepsy)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint. Regarding QOLIE-31, among FAS population, the patients who have both of baseline and 16 week evaluation are included.|||Units on a Scale||Standard Deviation|Mean
1414836|NCT01140867|Secondary|Responder Rate|The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.|||Percentage of Participants|||Number
1414837|NCT01140867|Secondary|Seizure Free Rate|The percentage of the participants who experienced no seizure during the trial.|16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.|||Percentage of Participants|||Number
1414838|NCT01140867|Primary|Seizure Reduction Rate|The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.|Baseline and 16 weeks|Efficacy analyses were based on the FAS (Full analysis set) population, which was comprised of all patients who administrated Zonisamide at least once and reached the maintenance period to evaluate the primary endpoint.|||Percentage of Seizure Reduction Rate||Standard Deviation|Mean
1414839|NCT01140815|Secondary|2-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|2 years|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
1416002|NCT01130597|Secondary|Mean Change From Baseline in Serum Potassium to End of Treatment||56 Days||||mEq/L||Standard Deviation|Mean
1414840|NCT01140815|Secondary|1-year Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|1 year|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
1414841|NCT01140815|Secondary|4-month Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|4 months|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
1414842|NCT01140815|Secondary|6-week Functional Testing|A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.|6 weeks|Patients who were not revised and were able to make an appointment and complete the testing did so.|||seconds||Standard Deviation|Mean
1414843|NCT01140815|Secondary|2-year Patient Surveys|Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).|2 years|Patients who were not revised within 2 years and were able to complete a questionnaire did so.|||units on a scale 0-48||Full Range|Mean
1414844|NCT01140815|Secondary|2-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 2 years are reported.|2 years||||participants|||Number
1414845|NCT01140815|Secondary|1-year X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 1 year are reported.|1 year||||participants|||Number
1414846|NCT01140815|Secondary|4-month X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 4 months are reported.|4 months||||participants|||Number
1414847|NCT01140815|Secondary|6-Week X-rays|Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies > 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.|6 weeks||||participants|||Number
1414848|NCT01140815|Primary|1-year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|1 year||||units on a scale 0-100||Standard Deviation|Mean
1414849|NCT01140815|Primary|4-Month Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|4 months||||units on a scale 0-100||Standard Deviation|Mean
1414850|NCT01140815|Primary|6-Week Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|6 weeks||||units on a scale 0-100||Standard Deviation|Mean
1414851|NCT01140815|Primary|2-Year Knee Society Score|Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.|2 years||||units on a scale 0-100||Standard Deviation|Mean
1414852|NCT01140646|Secondary|Adverse Event Grade Incidence||End of study|||||||
1414853|NCT01140646|Secondary|Change From Baseline in Self-assessment Items||End of study|||||||
1414854|NCT01140646|Primary|Percent of Baseline in Average Hot Flash Activity (Score and Frequency)|Hot flash score was defined as the number of mild hot flashes for the week plus two times the number of moderate hot flashes plus three times the number of severe hot flashes plus four times the number of very severe hot flashes. Hot flash frequency was defined as the average number of hot flashes per day for each week. Week 7 percent of baseline was calculated. The reduction in hot flash score and frequency can be calculated by subtracting the week 7 percent of baseline from 100 percent.|From baseline to week 7|Analysis population includes only the subjects who have completed the quality of life self-assessment questionnaire.|||Percent of baseline||95% Confidence Interval|Mean
1414855|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy as Measured by the Mean Change in CDASI-activity at 12 Weeks|The CDASI (Cutaneous Dermatomyositis Activity and Severity Index) is a validated instrument to measure skin disease activity in dermatomyositis. A clinically meaningful change is a decrease of 4 points. All missing data are imputed using last observation carried forward. Calculation is performed as the score at 12 weeks minus the score at baseline.|Data collected at baseline at 12 weeks||||units on a scale||Standard Deviation|Mean
1414856|NCT01140503|Secondary|The Secondary Outcome Measure Will be Efficacy, as Measured by the Number of Participants Experiencing a 30% Decreased in the CDASI-a Score at 12 Weeks.|This was an intent to treat analysis--dropouts are considered treatment failures. Missing data at 12 weeks imputed by last observation carried forward.|Data collected at 12 weeks after baseline visit.||||participants|||Number
1414857|NCT01140503|Primary|The Primary Endpoint Analysis Will be Safety, as Measured by the Number of Adverse Events and Serious Adverse Events Occuring During 12 Weeks of Therapy and 4 Weeks of Followup.||16 weeks||||adverse events|||Number
1414858|NCT01140477|Secondary|Visual Acuity|Best-Corrected Distance Visual Acuity (BCDVA) without Glare (logMAR)|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||logMAR||Standard Deviation|Mean
1414859|NCT01140477|Secondary|Lens Misalignment|This Outcome Measure was evaluated for Crystalens Toric IOL arm only - Toric IOLs require precise alignment to correct astigmatism; control IOLs do not.|120 - 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||degrees||Standard Deviation|Mean
1414860|NCT01140477|Primary|Percent Reduction in Absolute Cylinder|Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.|120 – 180 day postoperative visit|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||percentage of intended cylinder reduct||95% Confidence Interval|Mean
1414861|NCT01140360|Primary|Disease Response|To estimate the disease control rate (SD, PR, CR) with Gleevec/Imatinib Mesylate in patients with neurofibromas (NF1). The sum of the longest diameter (LD) for all target lesions will be calculated and reported as the disease measurement. Complete Response (CR) disappearance of target lesions. Partial Response (PR) at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Progressive Disease (PD) at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment. Stable Disease (SD) neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest disease measurement since the treatment started.|1 year|13 participants reached the 1 year evaluation time-point. 6 participants withdrew prior to the 1 year evaluation time-point.|||Participants|||Count of Participants
1414862|NCT01140347|Secondary|Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]|Participants were considered positive for anti-ramucirumab antibodies [anti-drug antibodies (ADA)] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.|Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)|Participants who received at least 1 dose of study drug and had post-treatment ADA analysis.|||participants|||Number
1414863|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 7||1 hour following completion of Cycle 7 (14-day cycles) infusion|Participants who received Cycle 7 of Ram and had Cmax results.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1414864|NCT01140347|Secondary|Cmax of Ramucirumab, Cycle 4||1 hour following completion of Cycle 4 (14-day cycles) infusion|Participants who received Cycle 4 of Ram and had Cmax results.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1414865|NCT01140347|Secondary|Maximum Concentration (Cmax) of Ramucirumab, Cycle 1||1 hour following the completion of Cycle 1 (14-day cycle) infusion|Participants who received Cycle 1 of Ram and had Cmax results.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1414866|NCT01140347|Secondary|Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died|The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 37 months)|Participants who received at least 1 dose of study drug.|||participants|||Number
1414867|NCT01140347|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score|The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)|Randomized participants who had an EQ-5D score at baseline and the specified time points.|||units on a scale||Standard Deviation|Mean
1414868|NCT01140347|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)|The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).|Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)|Randomized participants who had FHSI-8 at baseline and the specified time points.|||units on a scale||Standard Deviation|Mean
1414869|NCT01140347|Secondary|Time to Radiographic Progression (TTP)|TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=86, Pl=52.|||months||95% Confidence Interval|Median
1414898|NCT01139801|Primary|Rate of Induction To Delivery|To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times|24 hrs|Patients requiring caesarean section excluded from analysis.|||minutes||Standard Deviation|Mean
1415759|NCT01132846|Secondary|Dyspnea Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||units on a scale * hours||Standard Deviation|Mean
1414870|NCT01140347|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to <10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) * 100.|Baseline to the date of first evidence of confirmed CR or PR (up to 37 months)|ITT Population: All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1414871|NCT01140347|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.|Randomization to PD (up to 36 months)|ITT Population: All randomized participants. Participants censored: Ram=43, Pl=19.|||months||95% Confidence Interval|Median
1414872|NCT01140347|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death from any cause (up to 37 months)|Intent-to-treat (ITT) Population: All randomized participants. Participants censored: Ramucirumab+BSC (Ram)=65, Placebo+BSC (Pl)=58.|||months||95% Confidence Interval|Median
1414873|NCT01140295|Secondary|Proportion of Patients With Abnormal Electrolyte Levels|"The outcome measure was comparison of the proportions of patients who had abnormal electrolyte levels between two groups of patients, Miralax and senna.~Sodium, potassium, chloride, and carbon dioxide levels were measured in mmol/L while urea nitrogen, creatinine, glucose, calcium, magnesium, and phosphorus were measured in mg/dL. Each of these values has a reference range which varies with patients' age and sex. Minimal change of one point above or below normal reference range was dismissed as clinically insignificant. Abnormal creatinine levels were rechecked through glomerular filtration rate calculation to determine if there was any compromise in renal function since abnormal creatinine level does not mean there is renal dysfunction nor that the level is clinically significant."|The outcome measure will be assessed once one day after the completion of colonoscopy preparation||||Proportion of patients|||Number
1414874|NCT01140295|Primary|Efficacy of Colon Preparation|Percentage of patients with excellent or good colonoscopy preparation. The efficacy of preparation is measured by using a validated colon cleanliness scale which has 5 different levels (Aronchik scale). Levels 1 and 2, which encompass excellent and good colonoscopy preparation, are routinely recognized as adequate preparation allowing for successful completion of colonoscopy. Levels 3-5 describe incomplete or poor preparation. These levels are associated with significant residual stool encountered at the time of colonoscopy.|The outcome measure will be assessed once one day after the completion of colonoscopy preparation||||percentage of patients|||Number
1414875|NCT01140191|Secondary|Complete Cure of Index Lesion by Day 100|Number of participants with complete cure of index lesion by day 100. Cure rate is defined as 100% re-epithelialization of an ulcerated lesion|100 days|Analysis per protocol|||Participants|||Count of Participants
1414876|NCT01140191|Secondary|Cures of All Other Lesions|Number of participants with 100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions|100 days|Analysis per protocol|||Participants|||Count of Participants
1414877|NCT01140191|Primary|Number of Participants With No Relapse of Index Lesion Between Nominal Day 60 and 100|Number of participants with no relapses of lesion between 60 and 100 days. Relapse is defined as a 10% or greater increase in the area of ulceration of the index lesion or a shift from 100% re-epithelialization to < 100% re-epithelialization of the index lesion at Day 100 for those subjects that had 100% re-epithelialization of the index lesion at nominal Day 60 or before|60-100 days|Analysis per protocol|||Participants|||Count of Participants
1414878|NCT01140191|Primary|Number of Participants Demonstrating Initial Clinical Improvements|Number of participants with > 50% re-epithelialization of index lesion by Day 60 followed by complete re-epithelialization of index lesion on or before nominal Day 100;|60-100 days|Analysis per protocol|||Participants|||Count of Participants
1414879|NCT01140191|Primary|100% Re-epithelialization of Index Lesion by Nominal Day 60|Number of participants with 100% re-epithelialization of index lesion by nominal Day 60|Day 60|Analysis per protocol|||Participants|||Count of Participants
1414880|NCT01140191|Primary|Number of Adverse Events|Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs|3 months|Analysis was per protocol|||Adverse Events|||Number
1414881|NCT01140061|Primary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 28|The population consisted of all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1415034|NCT01138150|Secondary|Leptin|serum leptin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
1415760|NCT01132846|Secondary|Change in Serum Creatinine||randomization to 72 hours||||mg/dL||Standard Deviation|Mean
1414882|NCT01140061|Primary|Number of Participants With an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 14 days after last dose of study drug (up to Day 42)|The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.|||Participants|||Number
1414883|NCT01140061|Primary|Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days|Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis|Day 11|The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.|||nM||Standard Deviation|Mean
1414884|NCT01140061|Primary|Number of Participants With an Adverse Event of Erythema in Part I of the Study|Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to Day 22 in Part 1|The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.|||Participants|||Number
1414885|NCT01140048|Secondary|Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor|"Use of Chronic Asthma Therapy for the period of 12 months prior to the age of 6 years was defined by clinical review of reported concomitant medications.~Prognostic factors for use of chronic asthma therapy at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available.|||percentage of participants|||Number
1414886|NCT01140048|Secondary|Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor|"Atopic disorders include allergic rhinitis (AR) and/or atopic dermatitis (AD). Atopic disorders was defined as a positive response to the Epidemiology Questionnaire item In the past 6/12 months, has your child had a problem with sneezing or runny or blocked nose when he/she did not have a cold or the flu? for AR and/or a positive response to both of the following items for AD: Has your child had an itchy rash which was coming and going at any time in the past 6/12 months? and Has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears, or eyes? for the period of 12 months prior to age 6 years.~Prognostic factors for atopic disorders at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.|||percentage of participants|||Number
1414887|NCT01140048|Primary|Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor|"Asthma was defined as a positive response to the Epidemiology Questionnaire item Has your child had wheezing or whistling in the chest in the past 6/12 months? for the period of 12 months prior to age 6 years.~Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model."|At 6 years of age|All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.|||percentage of participants|||Number
1414888|NCT01139996|Secondary|Mean Incidence and Duration of Delirium|As assessed by daily CAM score currently used. data were not collected|2 or more years|||||||
1414889|NCT01139996|Secondary|Time to Pass First SBT Following Administration of the First Dose of Clonidine or Placebo|Hours. data were not collected|2 or more years|||||||
1414890|NCT01139996|Secondary|Incidence and Duration in Hours of Delirium Currently Used|As assessed by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score Data were not collected|2 or more years|||||||
1414891|NCT01139996|Primary|Duration of Mechanical Ventilation Following Administration of the First Dose of Clonidine or Placebo|data were not collected|2 or more years|data were not collected||||||
1414892|NCT01139879|Secondary|Healing Rate Per Week|The mean change in area per week for all ulcers|12 weeks|Rate of change in area (healing) for all ulcers on all subjects in area (cm^2)/week|||cm^2/week|Participants|Standard Deviation|Mean
1414893|NCT01139879|Secondary|Incidence of New Ulcers|incidence of new ulcers while on the study surface|12 Weeks||||percentage of participants|||Number
1414894|NCT01139879|Primary|Change From Baseline in Ulcer Surface Area at Week 12|The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.|12 Weeks|Ulcers decreased an average of 7.96 cm^2 (+/- 8.1 cm^2) over the 12 week period|||cm^2|Participants|Standard Deviation|Mean
1414895|NCT01139814|Primary|Evaluation of Major Complications|Safety Evaluation of Major Complications definitely or probably related to Amigo-Controlled Mapping through Visit 3 follow-up.|Seven Days (visit 3), except for any subject with an ongoing SAE that is related to the study will be scheduled for additional evaluations at 14 day intervals.||||Participants||95% Confidence Interval|Number
1414896|NCT01139814|Primary|Navigation Performance|Effectiveness Navigation Performance -- The ability to navigate the mapping catheter under Amigo control to at least 80% of 8 pre-specified anatomical locations over all subjects.|During Procedure||||Successful locations|Participants|95% Confidence Interval|Number
1414897|NCT01139801|Secondary|Delivery Route|To assess for differences in delivery routes|24 hrs||||Participants|||Count of Participants
1415035|NCT01138150|Secondary|Low Molecular Weight (LMW):Total (T)-ADP|serum LMW:T-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ratio||95% Confidence Interval|Mean
1414899|NCT01139775|Secondary|Phase 2: Clinical Benefit Rate: Percentage of Participant Who Achieved a Response of Stable Disease (SD), Partial Response (PR), or Complete Response (CR)|Clinical benefit rate is the best response CR, PR, or SD as classified by the investigators according to the RECIST, v1.1 guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Randomization until date of disease progression or death (up to 6 months after the last participant was randomized)|All randomized Phase 2 participants.|||percentage of participants||90% Confidence Interval|Number
1414900|NCT01139775|Secondary|Phase 2: Proportion of Participants Receiving Maintenance Therapy||Cycle 5|Zero participants analyzed. Treatment with LY2603618 was discontinued after 25 October 2012, data was not collected for analysis of the Phase 2: Proportion of Participants Receiving Maintenance Therapy.||||||
1414901|NCT01139775|Other Pre-specified|Deaths|Deaths that occurred during the study are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Randomization through 12 months after the last participant was randomized|All enrolled participants.|||Participants|||Count of Participants
1414902|NCT01139775|Secondary|Phase 1: Document Any Antitumor Activity Per Radiological Scans and/or Tumor Markers|Overall response rate is presented. Overall response rate is defined as the percentage of participants with a best response of CR or PR as classified by the investigators according to RECIST, v1.1 criteria. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline through end of Phase 1|All randomized Phase 1 participants.|||percentage of participants||90% Confidence Interval|Number
1414903|NCT01139775|Secondary|Phase 2: Change From Baseline to Long-term Follow up in Lung Cancer Symptom Scale (LCSS)|"Health-related quality of life and participant symptoms were assessed using the LCSS (patient scale). However, improper implementation of questionnaires at the site level reduced the sponsor’s ability to accurately evaluate the impacted data. Therefore, the LCSS data should be interpreted with caution.~The LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS. The total LCSS score was calculated as the mean of 9 questions from the LCSS."|Randomization to the end of study (approximately 12 months after the last participant entered treatment)|All enrolled Phase 2 participants who had the baseline LCSS assessment and at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1414904|NCT01139775|Secondary|Phase 2: Pharmacokinetic: AUC (LY2603618)|AUC (0-24), AUC(0-tlast), and AUC(0-∞) values are reported for LY2603618. The number of pharmacokinetic observations (n) used in the analysis is presented.|Cycle 1/Day 2 - predose, immediately prior to the end of the LY2603618 infusion, and 2-6, 24-48, and 72-96 hours postdose|Phase 2 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1414905|NCT01139775|Secondary|Phase 2: Pharmacokinetic: Cmax (LY2603618)||Cycle 1/Day 2 - predose, immediately prior to the end of the LY2603618 infusion, and 2-6, 24-48, and 72-96 hours postdose|Phase 2 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1414906|NCT01139775|Secondary|Phase 1: Pharmacokinetic: AUC (Pemetrexed and Cisplatin)|AUC(0-tlast) and AUC(0-∞) values are reported for pemetrexed and t-platinum from cisplatin. The number of pharmacokinetic observations (n) used in the analysis is presented for each drug.|Pemetrexed: Cycle 1/Day 1 - immediately prior to end of pemetrexed infusion and 1, 2, 6 and 24 hours postdose. Cisplatin: Cycle 1/Day 1 - immediately prior to end of cisplatin infusion and 0.5, 1, 2, 6, 24, 72, 96, and 168 hours postdose.|Phase 1 participants who received at least 1 dose of pemetrexed or cisplatin and had samples collected for pharmacokinetic analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1414907|NCT01139775|Secondary|Phase 1: Pharmacokinetic: Area Under the Plasma Concentration Versus Time Curve (AUC) (LY2603618)|AUC from time zero to 24 hours (AUC[0-24]), AUC from time zero to the last time point with a measurable concentration (AUC[0-tlast]), and AUC from time zero to infinity (AUC[0-∞]) values are reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.|Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose|Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1414908|NCT01139775|Secondary|Phase 1: Pharmacokinetic: Cmax (Pemetrexed and Cisplatin)|Cmax for pemetrexed and total platinum (t-platinum) from cisplatin is reported. The number of pharmacokinetic observations (n) used in the analysis is presented for each drug.|Pemetrexed: Cycle 1/Day 1 - immediately prior to end of pemetrexed infusion and 1, 2, 6 and 24 hours postdose. Cisplatin: Cycle 1/Day 1 - immediately prior to end of cisplatin infusion and 0.5, 1, 2, 6, 24, 72, 96, and 168 hours postdose.|Phase 1 participants who received at least 1 dose of pemetrexed or cisplatin and had samples collected for pharmacokinetic analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1414909|NCT01139775|Secondary|Phase 1: Pharmacokinetic: Maximum Plasma Concentration (Cmax) (LY2603618)|Cmax is reported for each LY2603618 dose level on Cycle 1 /Day 2 and Cycle 2 /Day 2. The number of pharmacokinetic observations (n) used in the analysis is presented for each dose level and time point.|Cycle 1/Day 2 - immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose; Cycle 2/Day 2 - predose, immediately prior to end of LY2603618 infusion, and 1, 3, 6, 24, 48, 72, and 144 hours postdose|Phase 1 participants who received at least 1 dose of LY2603618 and had samples collected for pharmacokinetic analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1414910|NCT01139775|Secondary|Phase 2: Change in Tumor Size|Change in tumor size was based on tumor measurements collected according to RECIST, v1.1 guidelines. Tumor size is the sum of the tumor measurements (longest diameters) of target lesions at each tumor evaluation. Change in tumor size was defined as the change in log tumor size from baseline evaluation to the evaluation at the end of Cycle 2.|Baseline, end of Cycle 2|Participants with measureable disease (target lesions) at baseline who received at least 1 dose of study drug.|||centimeters||Standard Deviation|Mean
1414911|NCT01139775|Secondary|Phase 2: Overall Tumor Response Rate: Percentage of Participants Who Achieved a Confirmed Best Response of Completed Response (CR) or Partial Response (PR)|Overall response rate is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Randomization until date of disease progression (up to 6 months after the last participant was randomized)|All randomized Phase 2 participants.|||percentage of participants||90% Confidence Interval|Number
1414912|NCT01139775|Secondary|Phase 2: Overall Survival|Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.|Randomization to the date of death from any cause through the time of study discontinuation (approximately 12 months after last participant was randomized)|All randomized Phase 2 participants.|||months||90% Confidence Interval|Median
1414913|NCT01139775|Primary|Phase 1: Recommended Phase 2 Dose of LY2603618|The recommended Phase 2 dose for LY2603618 when administered approximately 24 hours after pemetrexed and cisplatin was based on the maximum tolerated dose (MTD) and achievement of predefined LY2603618 plasma systemic exposures targets (area under the LY2603618 plasma concentration versus time curve from time zero to infinity [AUC(0-∞)] >21,000 nanogram*hour/milliliter [ng*h/mL] and maximum LY2603618 plasma concentration [Cmax] >2000 nanograms/milliliter [ng/mL]).|Time of first dose to last dose|Phase 1 participants who received at least 1 dose of any of the study drugs.|||mg|||Number
1414914|NCT01139775|Primary|Phase 2: Progression-Free Survival Time|Progression-free survival (PFS) time is defined as the time from the date of randomization to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.|Randomization up to first date of PD or death from any cause (up to 6 months after the last participant entered treatment)|All randomized Phase 2 participants.|||months||90% Confidence Interval|Median
1414915|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF Questions 3 and 4 measurement.|||units on a scale||Standard Error|Least Squares Mean
1414916|NCT01139762|Secondary|Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks|Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.|Baseline, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline PVR measurement.|||milliliters (mL)||Standard Deviation|Mean
1414917|NCT01139762|Secondary|Clinician Global Impression of Improvement (CGI-I) at 26 Weeks|Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had CGI-I measurement at 26 weeks endpoint.|||participants|||Number
1414918|NCT01139762|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.|26 weeks|All randomized participants who received at least 1 dose of the study drug and had TSS-BPH measurement at 26 weeks endpoint.|||units on a scale||Standard Deviation|Mean
1414919|NCT01139762|Secondary|Patient Global Impression of Improvement (PGI-I) at 26 Weeks|Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).|26 weeks|All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.|||participants|||Number
1414920|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks|Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.|||units on a scale||Standard Error|Least Squares Mean
1414921|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.|||units on a scale||Standard Error|Least Squares Mean
1414922|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.|||units on a scale||Standard Error|Least Squares Mean
1414923|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.|||units on a scale||Standard Error|Least Squares Mean
1414924|NCT01139762|Secondary|Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.|||units on a scale||Standard Error|Least Squares Mean
1414925|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks|"IPSS Quality of Life Index assesses participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction."|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.|||units on a scale||Standard Error|Least Squares Mean
1414926|NCT01139762|Secondary|Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 12 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.|||units on a scale||Standard Error|Least Squares Mean
1414927|NCT01139762|Secondary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 4 weeks, 26 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1414928|NCT01139762|Primary|Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks|The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.|Baseline, 12 weeks|All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
1414929|NCT01139658|Secondary|Reasons for Usual Follow-up||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1414930|NCT01139658|Secondary|Reasons for Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.||||||
1414931|NCT01139658|Secondary|Duration of Unplanned Hospitalizations at Visit 3||11 weeks|Outcome measure was not analyzed.||||||
1414932|NCT01139658|Secondary|Frequency of Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||times per week||Standard Deviation|Mean
1414933|NCT01139658|Secondary|Reasons for Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1414934|NCT01139658|Secondary|Prescription for Nursing Care and Nurse Visits on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1414935|NCT01139658|Secondary|Prescription for the Surveillance of the Platelet Count on the Day of Hospital Discharge||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1414936|NCT01139658|Secondary|Number of Patients Who Switched to Another Anticoagulant Therapy|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|11 weeks||||participants|||Number
1414937|NCT01139658|Secondary|Concomitant Treatments|Concomitant treatments prescribed at hospital discharge.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1414938|NCT01139658|Secondary|Adherence to Treatment|The adherence to treatment was measured by patient declaration.|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||percent||Standard Deviation|Mean
1414939|NCT01139658|Secondary|Proportion of Patients With a Preoperative ALT Measurement||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||percentage of participants|||Number
1414940|NCT01139658|Secondary|Duration of Treatment||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||days||Standard Deviation|Mean
1414941|NCT01139658|Secondary|Duration Between Surgery and First Dose of Pradaxa||11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||hours||Standard Deviation|Mean
1414942|NCT01139658|Secondary|Dosage of Pradaxa at Initiation||Baseline|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1414943|NCT01139658|Primary|Occurrence of Major Bleeding Events|"Occurrence of major bleeding events (MBEs) in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either THR or TKR surgery). MBEs were defined as any fatal haemorrhage, any overt bleeding greater than could be expected combined with a loss of haemoglobin ≥ 2 g/dL or requiring transfusion ≥ 2 packed red blood cells units (PRBC), any symptomatic retroperitoneal, intracranial, intraocular or intraspinal haemorrhage or any bleeding requireing treatment cessation or reoperation.~a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary emboliam (PE)."|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1414944|NCT01139658|Primary|Occurrence of Symptomatic Venous Thromboembolic Events|Occurrence of symptomatic venous thromboembolic (VTE) events in patients treated with Pradaxa (dabigatran etexilate) after orthopaedic surgery (either Total Hip Replacement (THR) or Total Knee Replacement surgery (TKR)). Symptomatic VTE events were defined as a confirmed proximal or distal deep vein thrombosis (DVT) or a confirmed pulmonary embolism (PE).|11 weeks|Treated population included patients who took at least one dose of Pradaxa. One additional patient was excluded from the analysis as they were missing their date of first dose.|||participants|||Number
1416003|NCT01130597|Secondary|Mean Patiromer Dose at Week 8||Up to Week 8||||grams||Standard Deviation|Mean
1414945|NCT01139580|Secondary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8|The investigator assessed participants with psoriasis with body involvement using the ISGA, scored as: 0, clear, minor residual discoloration, no erythema, scaling, or plaque thickness; 1, almost clear, occasional fine scale, faint erythema, and barely perceptible plaque thickness; 2, mild, fine scales predominate with light-red coloration and mild plaque thickness; 3, moderate, coarse scales predominate with moderate red coloration and plaque thickness; 4 severe, thick tenacious scale predominates with deep red coloration and severe plaque thickness. Scores are a visual average of lesions.|Week 8|ITT Population. Data were analyzed using the failure and LOCF methods.|||participants|||Number
1414946|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8|Psoriasis is a noncontagious skin disorder, most often appearing as inflamed, thickened skin covered with silvery white scales on the scalp, trunk, and limbs. The investigator assessed participants with plaque thickness at target lesions using the PGSTL scores: 0, no elevation over normal skin; 1, possible but difficult to ascertain whether there is a slight elevation above normal skin; 2, slight but definite elevation, edges are indistinct or sloped; 3, moderate elevation with rough or sloped edges; 4, marked elevation with hard or sharp edges; 5, very marked elevation with hard sharp edges.|Baseline and Week 8|ITT Population|||participants|||Number
1414947|NCT01139580|Primary|Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|ITT Population. Missing values were imputed using LOCF (i.e., the last available observation, including Baseline, for a participant will be used to estimate subsequent missing data points).|||participants|||Number
1414948|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8|Scaling of the skin is the loss of the outer layer of the epidermis in scale-like flakes. The investigator assessed participants with scaling at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of scaling; 1, minimal, occasional fine scale over less than 5% of the lesion; 2, mild, fine scales predominate; 3, moderate, coarse scales predominate; 4 marked, thick non-tenacious scale predominates; 5 severe, very thick tenacious scale predominates.|Baseline and Week 8|ITT Population|||participants|||Number
1414949|NCT01139580|Secondary|Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8|Erythema is redness of the skin, caused by increased blood flow in the capillaries in the lower layers of the skin. The investigator assessed participants with erythema at target lesions using the psoriasis grading scale for target lesions (PGSTL). PGSTL scores: 0, no evidence of erythema, hyperpigmentation may be present; 1, faint erythema; 2, light-red coloration; 3, moderate red coloration; 4, bright-red coloration; 5, dusky to deep red coloration.|Baseline and Week 8|ITT Population|||participants|||Number
1414950|NCT01139580|Primary|Number of Participants With an Investigator’s Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method|The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.|Week 8|Intent-to-Treat (ITT) Population: all participants who were randomized and dispensed study product. Missing values at Week 8 were considered to be failures. Failures were those participants who did not achieve a 2-grade improvement in IGSA score and a score of 0 or 1.|||participants|||Number
1414951|NCT01139515|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Hr||Standard Deviation|Mean
1414952|NCT01139515|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Hr||Full Range|Median
1414953|NCT01139515|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Full Range|Geometric Mean
1414954|NCT01139515|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose (D)|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Full Range|Geometric Mean
1415036|NCT01138150|Secondary|High Molecular Weight (HMW): T-ADP|serum HMW:T-ADP levels after treatment in responders and non responders|30 minutes, 60 minutes, 120 minutes after treatment||||ratio||95% Confidence Interval|Mean
1415037|NCT01138150|Secondary|Low Molecular Weight (LMW)-ADP|serum LMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
1414955|NCT01139515|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|Pre-dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post dose (A,B,C) and additional 2.5,2.75,3.5,5,14,18 and 26 hrs post dose(D)|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng* hr/mL||Full Range|Geometric Mean
1414956|NCT01139450|Secondary|The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)||Baseline, 4 weeks|||||||
1414957|NCT01139450|Secondary|The Mean Change From Baseline in Pruritus||Baseline, 4 weeks|||||||
1414958|NCT01139450|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region||Baseline, 4 weeks|||||||
1414959|NCT01139450|Primary|Incidence of Success Based on the Investigator’s Global Evaluation at the End of Treatment||4 weeks||||participants|||Number
1414960|NCT01139411|Secondary|Communication 2: Observed Parent-adolescent Communication Quality (DOCS)|Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations.|||units on a scale||Standard Deviation|Mean
1414961|NCT01139411|Secondary|Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)|Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only|||units on a scale||Standard Deviation|Mean
1414962|NCT01139411|Secondary|Parent Modeling 4: Weight and Body Concerns (FERF-Q)|Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only|||units on a scale||Standard Deviation|Mean
1414963|NCT01139411|Secondary|Parent Modeling 3: Physical Activity (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only|||units on a scale||Standard Deviation|Mean
1414964|NCT01139411|Secondary|Parent Modeling 2: Self-monitoring (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.|||units on a scale||Standard Deviation|Mean
1414965|NCT01139411|Secondary|Parent Modeling 1: Dietary Choices (WCSS)|Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.|Baseline to post-treatment|Secondary outcomes analyzed for treatment completers only.|||units on a scale||Standard Deviation|Mean
1414966|NCT01139411|Primary|Body Mass Index|Post-treatment BMI (controlling for baseline BMI)|Baseline and at completion of 16 week intervention||||kilograms/meters squared||Standard Deviation|Mean
1414967|NCT01139294|Secondary|Gorelick Assessment|"Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treatment or at discharge from the emergency dept.~volume of fluid infuse over time~time to discharge from ED to home or transfer into the hospital~discharge diagnosis from ED~duration of any supplemental hospitalization for supplemental hydration~time to first urine output observed~requirement for rescue therapy and nature of the rescue therapy~incidence of readmission to hospital/ED~global assessment of overall satisfaction with rehydration therapy by parents and caregiver"|Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study.|No outcome measure data available. Study data was lost.Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.||||||
1414968|NCT01139294|Primary|Cardiac Output Trends|Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration|Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study.|No outcome measure data available. Study data was lost. Data was left behind when PI left institution in 2013. Unable to find anyone with knowledge of data location.||||||
1416004|NCT01130597|Secondary|Mean Patiromer Dose at Week 4||Up to Week 4||||grams||Standard Deviation|Mean
1414969|NCT01139190|Primary|Degree of GI Injury at Day 15|"Degree of mucosal injury was assessed by endoscopy, with the following scoring system:~Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer"|15 days|Per Protocol Population: subset of participants who had an endoscopy performed at Day 15 reviewed by both blinded endoscopists, was at least 85% compliant with taking the study drug (based on pill counts), who took the final dose drug on the day of the second endoscopy, and who had no other protocol violations that would affect assessments.|||participants|||Number
1414970|NCT01139164|Secondary|Morbidity of Allogeneic Stem Cell Transplants|To determine the morbidity, including the pattern and severity of complications, of allogeneic stem cell transplants using reduced-intensity conditioning regimens. The average number of days spent in the hospital until day +100 will be reported as a surrogate for morbidity and complications.|100 days|This study terminated early; funding ran out before the analysis could be completed.||||||
1414971|NCT01139164|Secondary|To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants|To determine the engraftment rate of allogeneic stem cell transplants using reduced-intensity conditioning regimens. It will be measured as the proportion of subjects meeting criteria for engraftment before day +30 and full donor chimerism demonstrated before or at day +100. Engraftment is defined by maintenance of ANC > 500/mm3 for at least 3 consecutive days and platelet count > 20,000/mm3 for 3 consecutive days in absence of platelet transfusion. These criteria must have been met before Day +30. Chimerism is the pressence of donor cells and will be analyzed by FISH for sex-mismatched donor-recipient pairs and VNTR analysis for sex-mathced pairs. Chimerism by Day +100 will be documented for this outcome|Day +100|The outcome measure data below only accounts for the number of subjects who met the engraftment criteria prior at day +30; the chimerism data was not collected. For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.|||participants|||Number
1414972|NCT01139164|Primary|To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.|Number of subject deaths prior to day 100.|8 years|For regimen B, only the subjects who participated in study intervention were analyzed for outcome measures.|||participants|||Number
1414973|NCT01139125|Primary|Safety and Efficacy|We are measuring if this medication is appropriate for use in schizophrenia patients.|4 months|||||||
1414974|NCT01139047|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the subject preference survey at week 3|3 weeks|Safety|||participants|||Number
1414975|NCT01139047|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|day 22||||participants|||Number
1414976|NCT01139047|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety|||participants|||Number
1414977|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.|Up to 7 days after any vaccination|The analysis was done on safety subset.|||Number of Subjects|||Number
1414978|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the safety and tolerability by reporting solicited local and systemic adverse events of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|Up to 7 days after any vaccination.|The analysis was done on safety subset.|||Number of subjects|||Number
1414979|NCT01139021|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving a Booster (3rd) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events in yerms of serious adverse events (SAEs), atleast possibly related SAEs and AEs leading to withdrawl of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.|The analysis was done on safety subset.|||Number of Subjects|||Number
1414980|NCT01139021|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Receiving a Booster (Third) Dose of rMenB+OMV NZ Administered at One Year After Two Catch-up Doses of rMenB+OMV NZ, Previously Administered to Children.|To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1.|Up to 7 days after any vaccination.||||Number of subjects|||Number
1414981|NCT01139021|Secondary|GMCs to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.~Analysis was done on MITT population (Secondary)."|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).|||Concentration IU/mL||95% Confidence Interval|Geometric Mean
1416005|NCT01130597|Secondary|Mean Patiromer Dose at Week 1||Up to Week 1||||grams||Standard Deviation|Mean
1414982|NCT01139021|Secondary|Percentage of Subjects With Four Fold Increase in hSBA to Assess Antibody Response at 1 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|"To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains.~Analysis was done on MITT population (Secondary)."|1 month post two catch-up doses versus prevaccination|Analysis was done on MITT population (Secondary).|||Percentage of subjects||95% Confidence Interval|Number
1414983|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary)|||Percentage of subjects||95% Confidence Interval|Number
1414984|NCT01139021|Secondary|GMTs to Characterize Antibody Response at 1 Month and 6 Month Post Two Catch-up Doses of rMenB+OMV NZ Administered to Naive Children at 24 and 26 Months of Age.|To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.|1 month and 6 months post two catch-up doses.|Analysis was done on MITT population (Secondary).|||Titers||95% Confidence Interval|Geometric Mean
1414985|NCT01139021|Secondary|GMCs to Assess Antibody Persistence at One Year After Two Catch-up Doses and 6 Months After Booster of rMenB+OMV NZ Vaccination Against 287-953 Strain.|"To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).|||Concentration IU/mL||95% Confidence Interval|Geometric Mean
1414986|NCT01139021|Secondary|Percentage of Subjects With at Least Four Fold Increase in hSBA Titers to Evaluate Antibody Response 1 Month Post Booster Dose of rMenB+OMV NZ Vaccination.|To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age.Both the groups received MMRV at 12 months of age.|1 month post booster dose versus prebooster.|Analysis was done on MITT population (Secondary).|||Percentage of Subjects||95% Confidence Interval|Number
1414987|NCT01139021|Secondary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at 12 Months After Two Catch up Doses and 6 Months After a Booster Doses of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|6month post booster dose and 12 months post two catch-up dose vaccination.|Analysis was done on MITT population (Secondary).|||Percentage of subjects||95% Confidence Interval|Number
1414988|NCT01139021|Secondary|GMTs to Assess Antibody Persistence at 12 Months After Two Catch-up Doses and 6 Months After Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.~Both the groups received MMRV at 12 months of age."|12 months post two catch-up dose vaccination and 6 months post booster dose.|Analysis was done on MITT population (Secondary).|||Titers||95% Confidence Interval|Geometric Mean
1414989|NCT01139021|Primary|Geometric Mean Concentrations (GMCs) to Assess Antibody Persistence at One Year After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953.~Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).|||Concentration IU/mL||95% Confidence Interval|Geometric Mean
1414990|NCT01139021|Primary|Percentage of Subjects With hSBA ≥1:5 and hSBA ≥1:8 to Assess Antibody Persistence at on 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).~Analysis was done on MITT population (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on MITT population (Primary).|||Percentage of subjects||95% Confidence Interval|Number
1414991|NCT01139021|Primary|Geometric Mean Titers (GMTs) to Assess Antibody Persistence at 12 Months After a Booster Dose of rMenB+OMV NZ Vaccination.|"To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately).~Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary)."|12 months post booster (fourth) vaccination.|Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).|||Titers||95% Confidence Interval|Geometric Mean
1414992|NCT01139008|Secondary|6 Question Subject Preference Survey at Week 3|Number of participants per response to each question of the Subject Preference Survey at week 3|week 3|Safety|||participants|||Number
1415038|NCT01138150|Secondary|Middle Molecular Weight (MMW)-ADP|serum MMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
1414993|NCT01139008|Secondary|Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22.|Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.|Day 22|Safety|||participants|||Number
1414994|NCT01139008|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.|baseline to week 3|Safety|||participants|||Number
1414995|NCT01138995|Secondary|User Satisfaction|Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,|Week 30|All randomized subjects were analyzed.|||units on a scale||Standard Deviation|Mean
1414996|NCT01138995|Secondary|Berg Balance Scale (BBS) Score|Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.|Week 30|All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.|||units on a scale||Standard Deviation|Mean
1414997|NCT01138995|Primary|Ten Meter Walk Test (10mWT)|"Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard usual ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm."|Week 30|Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.|||meters per second (m/s)||Standard Deviation|Mean
1414998|NCT01138969|Secondary|Peptic Ulcer Bleeding|participants with peptic ulcer bleeding within 6 months|6 months|Intention to treat|||participants|||Number
1414999|NCT01138969|Primary|Recurrent Peptic Ulcer|Number of participants with recurrent peptic ulcer within 6 months|6 months|Intention to treat|||participants|||Number
1415000|NCT01138826|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1415001|NCT01138826|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1415002|NCT01138826|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Full Range|Geometric Mean
1415003|NCT01138826|Primary|AUC From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
1415004|NCT01138826|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr*ng/mL||Full Range|Geometric Mean
1415005|NCT01138735|Secondary|Change in Inflammatory Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF|||lesion count change||Standard Deviation|Mean
1415006|NCT01138735|Secondary|Percent Change in Total Lesion Counts From Baseline||Baseline to Week 12 (LOCF)|ITT Population, LOCF|||percentage of change in lesion count||Standard Deviation|Mean
1415007|NCT01138735|Primary|Change From Baseline in Total Lesion Counts||Baseline to Week 12 (LOCF)|ITT population, LOCF|||lesion count change||Standard Deviation|Mean
1415008|NCT01138735|Primary|Success Rate|Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)|Baseline to Week 12 (Last Observation Carried Forward [LOCF])|Intent to treat (ITT) population, LOCF|||percentage of participant|||Number
1415039|NCT01138150|Secondary|High Molecular Weight (HMW)-Adiponectin (ADP)|serum HMW-ADP levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
1415040|NCT01138150|Primary|Change in the Total Serum Adiponectin (T-ADP)|Change in total serum adiponectin after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
1416006|NCT01130597|Secondary|Mean Number of Patiromer Titrations||56 Days||||patiromer titrations||Standard Deviation|Mean
1416007|NCT01130597|Secondary|Median Time to First Patiromer Dose Titration||56 Days||||days||95% Confidence Interval|Median
1415009|NCT01138657|Secondary|Change in VFQ-25 Ocular Pain Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The ocular pain subscore is calculated from the answers to 2 ocular pain-related questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
1415010|NCT01138657|Secondary|Change in VFQ-25 Near Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
1415011|NCT01138657|Secondary|Change in VFQ-25 Distance Vision Subscore From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question.~The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
1415012|NCT01138657|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Composite Score From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline to Week 6 and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
1415013|NCT01138657|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Central retinal thickness was measured using optical coherence tomography and assessed by a central reader.|Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||percent change||Standard Deviation|Mean
1415014|NCT01138657|Secondary|Time to Optical Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 6|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 6 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline|||months||Inter-Quartile Range|Median
1415015|NCT01138657|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart.|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||logMAR||Standard Deviation|Mean
1415016|NCT01138657|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured."|From Baseline to Week 6 and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points; last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
1415056|NCT01138098|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
1415017|NCT01138657|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Best State Achieved Prior to Week 6 to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell;~Grade 0.5+ = 1-5 cells;~Grade 1+ = 6-15 cells;~Grade 2+ = 16-25 cells;~Grade 3+ = 26-50 cells;~Grade 4+ = > 50 cells."|From Baseline to Week 6 and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with values at both time points (best state achieved prior to Week 6 and at least 1 post-week 6 value); last observation carried forward (LOCF) imputation was used; participants with no values after Week 6 were excluded.|||units on a scale||Standard Deviation|Mean
1415018|NCT01138657|Primary|Time to Treatment Failure on or After Week 6|"Time to treatment failure was analyzed using Kaplan-Meier methods. Treatment failures on or after Week 6 were counted as events. Dropouts for reasons other than treatment failure at any time during the study were censored at the dropout date. To be considered a treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye:~New active, inflammatory chorioretinal or retinal vascular lesions relative to Baseline~Inability to achieve ≤ 0.5+ at Week 6 or a 2-step increase relative to best state achieved at all visits after Week 6 in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to best state achieved.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 6 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.|||months||Inter-Quartile Range|Median
1415019|NCT01138514|Secondary|Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)|Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.|10 weeks|per-protocol population|||participants|||Number
1415020|NCT01138514|Primary|Percent Change From Baseline in Non-inflammatory Lesions||10 weeks|Per protocol population|||percentage of lesion reduction||Standard Deviation|Mean
1415021|NCT01138514|Primary|Percent Change From Baseline in Inflammatory Lesions||10 weeks|Per protocol population|||percentage of lesion reduction||Standard Deviation|Mean
1415022|NCT01138501|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||events|||Number
1415023|NCT01138501|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.|The safety analysis set includes all 63 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 59 subjects had 50 exposure days (EDs).|||N with Inhibitors / N with ≥50 EDs|||Number
1415024|NCT01138475|Secondary|24 Hour Urine Calcium|This secondary outcome measure is change in 24-hour urine calcium from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks|Missing data from paricalcitol and cholecalciferol arms|||mg/dL||Standard Deviation|Mean
1415025|NCT01138475|Secondary|Bone Specific Alkaline Phosphatase|This secondary outcome measure is change in bone specific alkaline phosphatase from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks||||u/L||Standard Deviation|Mean
1415026|NCT01138475|Secondary|N-Telopeptide Cross Linked Urine|This secondary outcome measure is change in N-Telopeptide cross linked urine from baseline to final measure at 6 weeks, differences in the 3 arms were compared|6 weeks|Missing data from cholecalciferol and placebo participant arms|||nmol||Standard Deviation|Mean
1415027|NCT01138475|Secondary|Osteocalcin|This secondary outcome measure is change in osteocalcin from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|Missing data from all 3 participant arms|||ng/mL||Standard Deviation|Mean
1415028|NCT01138475|Secondary|Serum Phosphorus|This secondary outcome measure is change in serum phosphorus from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from all 3 participant arms|||mg/dL||Standard Deviation|Mean
1415029|NCT01138475|Secondary|Serum 25 OH Vitamin D|This secondary outcome measure is change in serum hydroxy-vitaminD from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from participant in paricalcitrol arm|||ng/dL||Standard Deviation|Mean
1415030|NCT01138475|Secondary|Serum Calcium|This secondary outcome measure is change in serum calcium from baseline to final measure at 6 weeks differences in the 3 arms were compared|6 weeks|missing data from participant in paricalcitrol|||mg/dL||Standard Error|Mean
1415031|NCT01138475|Secondary|Alkaline Phosphatase|This secondary outcome measure is change in alkaline phosphatase from baseline to final measure at 6 weeks differences were compared between the 3 arms of the study|6 weeks|missing 1 participant data in the paricalcitol group|||U/L||Standard Deviation|Mean
1415032|NCT01138475|Primary|The Primary Outcome Measure With iPTH|Change in iPTH was compared in each arm from baseline to final measure at 6 weeks the differences were compared in the 3 arms of the study|6 weeks|missing data in paricalcitol and placebo group|||pg/mL||Standard Deviation|Mean
1415033|NCT01138150|Secondary|Resistin|serum resistin levels after treatment in responders and non responders|30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment||||ug/mL||95% Confidence Interval|Mean
1415041|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile’s with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415042|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415043|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415044|NCT01138124|Primary|Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415045|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile’s with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415046|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile’s without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile’s with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415315|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - With pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
1415047|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile’s with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415048|NCT01138124|Primary|Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin|Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer).|The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case|Cases and controls were drawn from the GPRD study cohort. Entry into the study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Follow-up ended Dec 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death.|||participants|||Number
1415049|NCT01138111|Secondary|Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress|"Sensitivity, specificity, NPV and PPV were measured based on subject BAPL scores by time point and imaging window, compared to clinical diagnosis of AD during the study period. A BAPL score of 1 was considered negative for the presence of beta-amyloid, and scores of 2 and 3 were considered positive.~For this study, sensitivity was defined as the percentage of subjects with a clinical diagnosis of AD who also had a positive PET scan (BAPL score of 2 or 3) at the respective time point.~Specificity was defined as the percentage of subjects with a clinical diagnosis of non-AD who also had a negative PET scan (BAPL score of 0 or 1) at the respective time point.~PPV was defined as the probability that a subject with a positive PET scan would have a clinical diagnosis of AD sometime during the 2 year follow up period.~NPV was defined as the probability that a subject with a negative PET scan would not have a clinical diagnosis of AD at any point during the 2 year follow up period."|2 scanning periods post injection to be evaluated at baseline|All subjects with PET data at the referenced study time point|||percentage of subjects|||Number
1415050|NCT01138111|Secondary|Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress|At each study time point (baseline, 12 months and 24 months) PET images were obtained at 45 min and again at 90 post injection. These images were assigned a BAPL score of 1, 2 or 3 based on the reader’s evaluation of the scan. A BAPL scores of 1 was considered normal, and scores of 2 and 3 were considered abnormal. These scores were compared to subjects clinical diagnosis for AD at the end of the study follow up period.|2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months|All subjects with PET data at the referenced study time point|||participants|||Number
1415051|NCT01138111|Secondary|Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4|This outcome measure showed the number of abnormal scans in subjects with MCI progressing to AD and those who did not progress compared to subjects with normal scans that did not progress and those who did progress.|1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months|All subjects receiving study drug|||participants|||Number
1415052|NCT01138111|Primary|Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake|Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)|1 scanning period post injection to be evaluated at baseline, 12 months and 24 months|All subjects receiving study drug with PET scan data at the respective timepoint|||SUVR||Standard Deviation|Mean
1415053|NCT01138098|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|After the challenge dose of Engerix-B vaccine up to the study end|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
1415054|NCT01138098|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
1415055|NCT01138098|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal, headache and temperature (Temperature is defined as axillary temparature equal to or above 37.5 degrees Celsius (°C)).|During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine|The Total Vaccinated cohort included all subjects who received the challenge dose of Engerix-B vaccine.|||Participants|||Count of Participants
1416008|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Downtitration||56 Days||||percentage of participants|||Number
1416009|NCT01130597|Secondary|Percentage of Participants Requiring Patiromer Uptitration||56 Days||||percentage of participants|||Number
1415057|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before the challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
1415058|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL|A seroprotected subject was defined as a subject with anti-HBs antibody concentration ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|Before and one month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
1415059|NCT01138098|Secondary|Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL|A seropositive subject was defined as a subject with anti-HBs antibody concentration ≥ the 6.2 mIU/mLcut-off. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
1415060|NCT01138098|Secondary|Number of Subjects With an Anamnestic Response to a Challenge Dose|The anamnestic response was defined as: at least (≥) a 4-fold rise in post-challenge dose anti-HBs antibody concentrations in subjects seropositive at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations ≥ 10 mIU/mL in seronegative subjects at the pre-challenge dose time point. A seropositive/seronegative subject is a subject with anti-HBs antibody concentration ≥/lower than (<) 6.2 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before and one month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
1415061|NCT01138098|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month after a challenge dose of Engerix-B vaccine|The According-To-Protocol (ATP) cohort for analysis of immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complied with the procedures, with no elimination criteria) who had received a challenge dose Engerix-B vaccine and for whom immunogenicity data were available at the post-Engerix-B challenge time-point.|||Participants|||Count of Participants
1415062|NCT01138046|Secondary|Drug Clearance (CL) of Paclitaxel|CL is defined as the volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. CL was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation.|||mL/hour/m^2||95% Confidence Interval|Geometric Mean
1415063|NCT01138046|Secondary|Half-life (t1/2) of Paclitaxel|Half-life is defined as the time required for the amount of the drug in the plasma to decrease by half. T1/2 was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||Hr||95% Confidence Interval|Geometric Mean
1415064|NCT01138046|Secondary|Distribution Volume at Steady State (Vss) of Paclitaxel|Vss is the volume of distribution at steady state of paclitaxel. Vss was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||milliliter per meters squared (mL/m^2)||95% Confidence Interval|Geometric Mean
1415277|NCT01136408|Secondary|Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)|The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set|||seconds||Geometric Coefficient of Variation|Geometric Mean
1415065|NCT01138046|Secondary|Time to the Maximum Drug Concentration (Tmax) of Lapatinib and Paclitaxel|Tmax is defined as the time to peak concentration from initiation of lapatinib and paclitaxel dosing. Tmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||Hr||Full Range|Median
1415066|NCT01138046|Secondary|AUC From Time Zero to Infinity (0-INF) of Paclitaxel|AUC(0-INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. AUC (0-INF) was calculated from paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||hr*ng/mL||95% Confidence Interval|Geometric Mean
1415067|NCT01138046|Secondary|Area Under the Concentration-time Curve (AUC) (0-24) of Lapatinib and Paclitaxel|AUC is defined as the area under the lapatinib or paclitaxel concentration-time curve from time 0 to 24 hours (hrs). AUC (0-24) was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|PK Population: all participants who provided blood samples for PK evaluation|||hours * nanograms/milliliter (hr*ng/mL)||95% Confidence Interval|Geometric Mean
1415068|NCT01138046|Secondary|Maximum Plasma Concentration (Cmax) of Lapatinib and Paclitaxel|Cmax is defined as the maximum concentration of lapatinib and paclitaxel. Cmax was calculated from lapatinib plasma concentration-time data on Day 8 and Day 14 and paclitaxel plasma concentration-time data on Day 1 and Day 8 with model-independent analyses|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 8 and Day 14 for lapatininb; Day 1 and Day 8 for paclitaxel|Pharmacokinetic (PK) Population: all participants who provided blood samples for PK evaluation|||Nanogram per milliliter ng/mL||95% Confidence Interval|Geometric Mean
1415069|NCT01138046|Secondary|Number of Participants With Clinical Benefit Response (CBR)|CBR is defined using RECIST as the number of participants who received at least one dose of study medication and achieved a best OR classified as CR, PR or SD for at least 6 months (24 weeks), i.e., CR + PR + SD for >=24 weeks. CBR was based on confirmed responses by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. SD is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the the four preceding definitions was considered Not evaluable|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.|||Participants|||Number
1415070|NCT01138046|Secondary|Number of Partcipants With a Best Overall Response (OR) as Determined by the Response Evaluation Criteria in Solid Tumors (RECIST)|Best OR was defined as the best response recorded from the start of treatment until progressive disease (PD)/death as assessed by the investigator. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit. PD is defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of 1 or more new lesions compared to the smallest sum LD recorded since the treatment started. Stable disease (SD) is defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD compared to the smallest sum LD since the treatment started. Any participant who could not be classified by the four preceding definitions was considered Not evaluable.|From the start of treatment until progressive disease/death (up to 1009 Days).|All Subjects Population. All participants who received at least one dose of study medication.|||Participants|||Number
1415071|NCT01138046|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of a CR or a PR until the first documented sign of disease progression or death due to any cause (whichever occured earlier). The analysis was based on responses as evaluated by the investigator and was confirmed at a repeat assessment, with the duration of response taken from the first time the response was observed. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the LD of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the first documented evidence of a CR or a PR until the first documented sign of disease progression or death, whichever occurred earlier (up to 953 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed. For participants who did not progress or die, duration of response was censored on the date of the last assessment.|||Months||95% Confidence Interval|Median
1415072|NCT01138046|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until first documented evidence of partial response (PR) or a complete response (CR) (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as a reference, the Baseline sum LD. Baseline measurements were obtained at the Screening Visit.|From the start of treatment until the first documented evidence of a PR or CR, whichever status is recorded first (up to 66 Days).|All Subjects Population. Only those participants with a CR or a PR were assessed.|||Months||95% Confidence Interval|Median
1415106|NCT01137682|Secondary|Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)|Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm.|CORE and extension baseline up to approximately 268 weeks|Available data for analysis differed from visit to visit|||mcg/L||Standard Deviation|Mean
1415073|NCT01138046|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the start of treatment and the earliest date of radiological disease progression or death due to any cause, whichever occurred first. PFS was based on the investigator's assessment. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until the earliest date of radiological disease progression or death due to any cause, whichever occured first (up to 1009 Days).|All Subjects Population. Participants who met the following criteria were censored: no Baseline assessment, no progression, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment started, and death or progression after more than one missed visit.|||Months||95% Confidence Interval|Median
1415074|NCT01138046|Primary|Overall Survival|Overall survival is defined as the time from the start of treatment until death due to any cause. For participants who survived, time to death was censored at the time of the last confirmation of survival.|From the start of treatment until death due to any cause or study close, whichever occurred first (assessed up to a maximum of 1290 Days)|All Subjects Population: all participants who received at least one dose of study medication|||Months||95% Confidence Interval|Median
1415075|NCT01138046|Primary|Number of Participants With Intolerable Toxicities in Phase I of the Study|Investigational treatment was considered tolerable if one or more of the tolerability criteria were met by none or one of the 6 participants in the first cycle of Phase I. If one or more tolerability criteria were met by two or more participants, the issue was referred to the safety committee. Tolerability criteria for toxicities related to investigational treatment included grade 4 neutropenia persisting for 7 or more days, thrombocytopenia with a platelet count of less than or equal to 25,000/millimeter (mm)^3 , clinically significant Grade 3 or 4 non-haematologic toxicities (excluding nausea) and inability to start cycle 2 within 2 weeks of scheduled dosing due to unresolved toxicity.|28 days|All Subjects Population: all participants who received at least one dose of study medication and participated in Phase I of the study.|||Participants|||Number
1415076|NCT01138007|Secondary|Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). Only five items (item 19: general interest; item 20: energy level; item 21: capacity for pleasure or enjoyment, excluding sex; item 22: interest in sex; item 30: leaden paralysis/physical energy) were evaluated for this endpoint, as a subset of the total score. The lowest possible total score and subset total score of IDS-SR are 0 and 0, and the highest possible total score and subset total score of IDS-SR are 84 and 15, respectively. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR subscore and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1415077|NCT01138007|Secondary|Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8|The IDS-SR is a 30-item scale used to evaluate the severity and changes in depressive symptoms. Each item was scored from 0 (no symptoms) to 3 (greatest symptom severity). The maximum total score is 84 (0: no symptoms; 84: greatest symptom severity), as participants were asked to answer either item 11 (decreased appetite) or item 12 (increased appetite) (not both) and either item 13 (decreased weight) or item 14 (increased weight) (not both). Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline IDS-SR score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1415078|NCT01138007|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8|A CGI-SI assessment was performed in terms of severity in depression, by using scores from 0 to 7: 0, Not assessed; 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill participants. Change from Baseline in the CGI-SI score was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline CGI-SI score and region as covariates.|Baseline; Weeks 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1415079|NCT01138007|Secondary|Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8|A CGI-GI assessment was performed at Week 8 (or withdrawal) in comparison with severity in depression observed at Baseline (Week 0; no actual assessment was performed at Baseline [the comparison was subjective]), by using scores from 0 to 7: 0, Not assessed; 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; 7, Very much worse. A CGI-GI responder is defined as a participant with a CGI-GI score of very much improved or much improved at Week 8.|Week 8|FAS. Missing values were imputed using LOCF. Only those participants who were available at Week 8 were analyzed.|||participants|||Number
1415080|NCT01138007|Secondary|Number of MADRS Remitters at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS remitter is defined as a participant with a MADRS total score <=11 at Week 8.|Week 8|FAS. Missing values were imputed using LOCF.|||participants|||Number
1415107|NCT01137682|Secondary|Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)||CORE baseline up to approximately 24 weeks|Number analyzed is based on available data at specific visits|||mcg/L||Standard Deviation|Mean
1415797|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 78 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415081|NCT01138007|Secondary|Number of MADRS Responders at Week 8|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. A MADRS responder is defined as a participant with a >=50% reduction from Baseline in the MADRS total score at Week 8.|Baseline and Week 8|FAS. Missing values were imputed using LOCF.|||participants|||Number
1415082|NCT01138007|Secondary|Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8|The MADRS scale measures the depression level of a participant using the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). Scores for MADRS items 1, 2, 6, 7, and 8 were evaluated for this endpoint. Change from Baseline was calculated as the value at Week 1, 2, 4, 6, and 8 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score of each item and region as covariates.|Baseline; Week 1, 2, 4, 6, and 8|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1415083|NCT01138007|Secondary|Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 1, 2, 4 and 6 minus the value at Baseline. The least squared means were estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|Baseline; Weeks 1, 2, 4, and 6|FAS. Missing values were imputed using LOCF. Only participants who were available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1415084|NCT01138007|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal|The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. Change from Baseline in the total score was calculated as the value at Week 8/Withdrawal minus the value at Baseline. The least squared means were estimated based on the Analysis of Covariance (ANCOVA) model including Baseline MADRS score and region as covariates.|Baseline and Week 8/Withdrawal|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e. Week 1 or later). Missing values were imputed using Last Observation Carried Forward (LOCF): last observed non-missing value was used to fill missing values at a later point.|||Scores on a scale||Standard Error|Least Squares Mean
1415085|NCT01137890|Secondary|Drug Value Questionnaire|"Street Value of Sampled Dose. After co-administration of cocaine-zonisamide, participants were asked to hypothetically estimate the value of the drug they received, if they were to purchase it on the street. The mean value (dollars) across all drug conditions is reported here.~Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (0, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis. Additionally, all 8 subjects who received zonisamide completed both 300mg and 600mg doses.~Within-subject repeated interval during self-administration sessions. Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times"|Weeks 1-5; mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administration cocaine-zon affects this measure, only zon participants are included (n=8). Each participant receives varying doses of zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5|||dollars||Standard Deviation|Mean
1415086|NCT01137890|Primary|Cocaine Craving|Cocaine craving measured by Cocaine Selectivity Severity Assessment (CSSA). The CSSA is a reliable and valid tool to measure cocaine withdrawal severity within a 24 hr period, and has been shown to predict treatment response in a treatment setting. Participants are asked to rate 18-items on a Likert scale 0-7, with composite scores ranging 0-126 and higher numbers indicative of more severe withdrawal. Mean scores on CSSA across 39-day time period are reported.|Day 1-39|Includes all participants analyzed (n=12; 8 zonisamide, 4 placebo)|||units on a scale||Standard Deviation|Mean
1415087|NCT01137890|Primary|Behavioral Choice Measures|"In each condition of cocaine-zonisamide dose, participants were asked to choose whether they would rather have a repeated cocaine dose (same dose as most recent administration) or cash of varying monetary value. The mean number of cocaine choices across each drug condition are reported. This measure only included participants in the zonisamide (Zon) condition (n=8), with each arm representing variation in co-administration of cocaine-Zon.~Repeated within-subject measures ANOVA performed to observe the main effects of zonisamide dose (0, 300, and 600mg) and cocaine dose (1, 20, and 40mg), and their interaction. Only participants who received the active zonisamide medication (n=8) were included in this portion of the analysis.~During self-administration sessions are every 15 min over 1hr45min period. Assessment on Weeks 1 (0mg Zon), 3 (300mg Zon), 5 (600mg Zon), in which varying cocaine doses co-administered. Cocaine not administered (only Zon) during Weeks 2 & 4"|Weeks 1-5, mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administered of cocaine-Zon affects this measure, only Zon participants are included (n=8). Each participant receives varying doses of Zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each Zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5|||number of cocaine choices||Standard Deviation|Mean
1416010|NCT01130597|Secondary|Mean Dose of Patiromer at End of Treatment||56 Days||||grams||Standard Deviation|Mean
1415088|NCT01137890|Primary|Change in Visual Analog Questionnaire (VAQ) Score|VAQ measures the change in effect after dose administration. Participants rate 6 items (“Any Drug Effect”, “Rush”, “Good Effects”, “Bad Effects”, “Liking”, & “Desire for Cocaine”) by pointing an arrow along a 100-point line anchored at either end with “none” (0) & “extremely” (100). Each participant’s score is equal to the sum of all 6 ratings, & the mean of all participant’s scores is reported across each condition. The VAQ is only administered to subjects in the zonisamide (Zon) condition (n=8). Repeated within-subject measures ANOVA performed to observe the main effects of Zon dose (0, 300, & 600mg) & cocaine dose (1, 20, & 40mg), & their interaction. All 8 subjects who received Zon completed both 300mg & 600mg doses. Assessments obtained on Week 1 (0mg Zon), Week 3 (300mg Zon), & Week 5 (600mg Zon), in which all 3 cocaine were co-administered at these times. Cocaine not administered (only Zon) during Weeks 2 & 4, thus no measures taken at these times|Weeks 1-5; mean of weeks 1, 3 and 5 reported|Because we are interested in how co-administered of cocaine-Zon affects this measure, only Zon participants are included (n=8). Each participant receives varying doses of Zon (0, 300, 600mg) at weeks 1, 2-3, 4-5, respectively. After getting used to each Zon dose, they are co-administered all 3 cocaine doses (1, 20, 40mg) during Weeks 1, 3, and 5|||units on a scale||Standard Deviation|Mean
1415089|NCT01137812|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1415090|NCT01137812|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1415091|NCT01137812|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
1415092|NCT01137812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1415093|NCT01137812|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1415094|NCT01137812|Secondary|Percentage of Patients With HbA1c <7% at Week 52|The table below shows the percentage of patients with HbA1c <7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage.|Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1415095|NCT01137812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1415096|NCT01137786|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48 and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of non-ionic low osmolar contrast media.|Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1415097|NCT01137773|Secondary|Blood Glucose Concentration|average blood glucose concentration while the patients received insulin drip|24 h||||mg/dl blood||Standard Deviation|Mean
1415312|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco)|Change in diffusing capacity for carbon monoxide (DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||mL/min/mmHg||Standard Deviation|Mean
1415098|NCT01137773|Primary|Karnovsky Performance Status Scale of Functional Impairment|"The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Patients are assigned a value from 0 to 100 based on the following definitions:~Normal no complaints; no evidence of disease - 100 Able to carry on normal activity; minor signs or symptoms of disease- 90 Normal activity with effort; some signs or symptoms of disease - 80 Cares for self; unable to carry on normal activity or to do active work - 70 Requires occasional assistance, but is able to care for most of his personal needs - 60 Requires considerable assistance and frequent medical care - 50 Disabled; requires special care and assistance - 40 Severely disabled; hospital admission is indicated although death not imminent - 30 Very sick; hospital admission necessary; active s"|3 months||||units on a scale||Standard Deviation|Mean
1415099|NCT01137682|Secondary|Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set)|"PK samples were collected for those patients treated with pasireotide LAR in the core study and who continued on pasireotide LAR in the extension phase. PK samples were collected before the injection of pasireotide LAR only at weeks 112 and 196. PK samples were also collected at weeks 48 and 132 only for all patients treated with octreotide LAR 30 mg or lanreotide ATG 120 mg in the core study who started treatment with pasireotide LAR in the extension study.~Blood samples (2.5 mL each sample) were collected to yield 1-mL plasma for analysis of pasireotide LAR oncentration."|Extension baseline up to approximately 196 weeks|Available data for analysis varies at visits|||mL||Standard Deviation|Mean
1415100|NCT01137682|Secondary|Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)|Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score ‘appearance’ and ‘personal relations’). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.|CORE Baseline and extension baseline up to approximately 268 weeks|completed and valid questionnaires at visits|||scores on a scale||Standard Deviation|Mean
1415101|NCT01137682|Secondary|Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set)|Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score ‘appearance’ and ‘personal relations’). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.|CORE baseline up to approximately 24 weeks|Available data available for analysis differed from visit to visit|||scores on a scale||Standard Deviation|Mean
1415102|NCT01137682|Secondary|Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly|Time to first response is defined as the time from the date of first dose to the date of first occurrence of a reduction of mean GH < 2.5 µg/L and the normalization of IGF-1. The weeks correspond to time taken to achieve first mean GH < 2.5 µg/L and the normalization of IGF-1.|CORE baseline up to approximately 268 weeks||||weeks||95% Confidence Interval|Median
1415103|NCT01137682|Secondary|Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|n is the number of patients achieving response criteria. The weeks correspond to duration of first response (in weeks) for patients achieving biomedical control. Median and 95% CI are derived from Kaplan-Meier curves. Kaplan-Meier estimates [95% CI] at each time point are estimates of probability of response.|CORE baseline up to approximately 268 weeks||||weeks||95% Confidence Interval|Median
1415104|NCT01137682|Secondary|Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)|Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range|CORE and extension baseline up to approximately 268 weeks|Available data for analysis differed from visit to visit|||mcg/L||Standard Deviation|Mean
1415105|NCT01137682|Secondary|Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)|Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range|CORE baseline up to approximately 24 weeks|Available data for analysis varies from visit to visit|||mcg/L||Standard Deviation|Mean
1415147|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the tolerability of voriconazole at the EOT Visit.|||participants|||Number
1415108|NCT01137682|Secondary|Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 1.0 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)|Extension baseline up to approximately week 268||||percentage of participants||95% Confidence Interval|Number
1415109|NCT01137682|Secondary|Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 1.0 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set|Extension baseline up to approximately week 268||||Participants||95% Confidence Interval|Number
1415110|NCT01137682|Secondary|Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 2.5 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)|Extension baseline up to approximately week 268|Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.|||percentage of participants||95% Confidence Interval|Number
1415111|NCT01137682|Secondary|Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set).|The percentage of patients achieving normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)|Extension baseline up to approximately week 268||||percentage of participants||95% Confidence Interval|Number
1415112|NCT01137682|Secondary|Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)|The percentage of patients achieving mean growth hormone (GH) levels < 2.5 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (extension full analysis set)|Extension baseline up to approximately week 268||||percentage of participants||95% Confidence Interval|Number
1415113|NCT01137682|Primary|Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.|The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels <2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to < 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.|At 24 weeks||||percentage of participants||95% Confidence Interval|Number
1415114|NCT01137604|Primary|Progression Free Survival (PFS) Rate at Month 6|PFS at Month 6 was defined as the percentage of participants who remained alive and progression-free at Month 6, based on investigator's assessment. Progression was defined using Response Assessment in Neuro-Oncology (RANO) criteria, as a greater than 25% increase in enhancing lesions despite stable or increasing steroid dose, an increase (significant) in non-enhancing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) lesions that are not attributable to other non-tumor causes, and any new lesions. PFS rate at Month 6 was estimated from Kaplan-Meier (K-M) product-limit estimate of PFS.|At Month 6 from randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3)|Full Analysis Set included all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1415115|NCT01137604|Secondary|Pharmacokinetic (PK) Profile and Pharmacodynamics (PD) of Lenvatinib|Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.|Blood samples collected at Cycle 1 on Days 1 and 15 and in Cycle 2 on Day 1|||||||
1415124|NCT01137578|Secondary|Number of Deaths Which Occurred During the Study|Death as an endpoint in a participant with an adjudicated venous thromboembolism (DVT or PE) was summarized, regardless of the cause of the death. The VTE was adjudicated by a blinded central independent adjudication committee.|Enrollment up to last US or MRI plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.|||participants|||Number
1415116|NCT01137604|Secondary|Number of Participants With Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; results of physical examinations, regular measurement of vital signs, and electrocardiograms (ECGs), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.|For each participant, from the first patient first dose till 30 days after the last dose or the cut-off date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Participants|||Number
1415117|NCT01137604|Secondary|Clinical Benefit Rate (CBR)|CBR was the percentage of the participants who had BOR of CR, PR, and SD with the minimum duration of SD lasting greater than or equal to 23 weeks. Only participants with measurable disease at baseline were included in evaluation of CBR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1415118|NCT01137604|Secondary|Disease Control Rate (DCR)|DCR was the percentage of the participants who had BOR of CR, PR, and stable disease (SD) with the minimum duration of SD lasting greater than or equal to 7 weeks. Only participants with measurable disease at baseline were included in evaluation of DCR, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1415119|NCT01137604|Secondary|Overall Survival (OS)|OS was measured as the time from the randomization date (Cohort 1) or the first day of treatment (Cohort 2 and 3) to the date of death from any cause.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until death due to any cause or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Months||95% Confidence Interval|Median
1415120|NCT01137604|Secondary|Progression Free Survival|PFS was measured as the time from randomization (Cohort 1) or the first day of treatment (Cohorts 2 and 3) until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, based on investigator's assessment.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (ie, 2.4 years)|Full Analysis Set - all participants who received at least one dose of study drug|||Months||95% Confidence Interval|Median
1415121|NCT01137604|Secondary|Objective Response Rate (ORR)|ORR was the percentage of participants with best overall response (BOR) of complete response (CR) and partial response (PR) based on RANO criteria and investigator's assessment. CR was defined as the disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks, no new lesions, and stable or improved non-enhancing (T2/FLAIR) lesions. PR was defined as greater than or equal to 50% decrease, compared to baseline, in the sum of products of perpendicular diameters of all measureable enhancing lesions sustained for at least 4 weeks. No progression of non-measurable disease, no new lesions, stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared to baseline. For both CR and PR, in the absence of a confirming scan 4 weeks later, this scan was considered only stable disease. Only participants with measureable disease at baseline were included in evaluation of ORR.|From date of randomization (Cohort 1) or first day of treatment (Cohorts 2 and 3) until disease progression, development of unacceptable toxicity, withdrawal of consent or up to data cutoff date of 19 March 2013 (i.e., 2.4 years)|Full Analysis Set included all participants who received at least one dose of study drug|||Percentage of participants||95% Confidence Interval|Number
1415122|NCT01137578|Primary|All Participants With an Adjudicated Deep Vein Thromboembolism (DVT) By Study-Related Radiographic Procedures That Diagnosed the DVT|Adjudication was by an Independent Central Adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. One set of 3 study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|n=participants with an adjudicated DVT identified by a study-related adjudicated radiographic procedure.|||participants|||Number
1415123|NCT01137578|Primary|Number of Participants With an Adjudicated Deep Vein Thrombosis (DVT) Detected By a Study-Related Ultrasound (US) and/or MRI, By Cohort and Age Group|MRI with contrast (c) and without (w/o) contrast (c) enhancement were performed and a US was done within 48 hours of the MRI. Once detected, the DVT was adjudicated and confirmed by an independent central adjudication Committee (ICAC) consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. Participants were considered positive for DVT if at least one of the radiographic procedures was positive. Cohort A: Day 0=day of catheter placement; Day 40 (± 20 days)=day of imaging procedures at Visit 1, or if possible within 72 hours after a CVC is removed or lost. Cohort B Visit 1: within 7 days of initiation of symptoms of a CVC-related DVT (symptoms include but were not limited to: redness, pain/tenderness, swelling, presence of subcutaneous collaterals, catheter occlusion, and the presence of catheter related infection) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure. n=number of adjudicated images|||participants|||Number
1415142|NCT01137435|Primary|Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Participants|||Number
1415125|NCT01137578|Primary|Number of Participants and Reasons for Non-Completion of Each of the Imaging Procedures, Ultrasound (US), MRI With Contrast and MRI Without Contrast|Bilateral US was attempted but if it could not be completed, a unilateral US was accepted for analysis. Participants who did not complete the MRI procedure with contrast could be different participants from those who did not complete the MRI procedure without contrast. Primary reasons for non-completion of imaging included: technical, investigator decision, child refused, parent refused, child missed appointment, difficulties with anesthesia/sedation, child unable to lie still, problems with contrast administration, and other reasons. Other reasons could include: late to appointment and unable to perform MRI due to time constraints; logistical reasons, parent agreed to only ultrasound at time of consent, schedule delay, equipment not available, difficulty putting patient in correct position. Due to the small numbers of participants in some cohorts, these data were more meaningful with all cohorts grouped together for the total imaged population.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|Participants had at least 1 radiographic procedure performed but were unable to complete a either an Ultrasound (neither bilateral or unilateral, or could complete only a unilateral US) and/or unable to complete an MRI with contrast and/or unable to complete an MRI without contrast.|||participants|||Number
1415126|NCT01137578|Primary|Number of Participants Who Required Sedation/Anesthesia With the Study-Related Radiographic Procedures, by Cohort and Age|One set of diagnostic imaging procedures (US and MRI) was to be performed for all cohorts The MRI consisted of MRI venous imaging without contrast enhancement and MRI venous imaging with contrast enhancement.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all participants who had at least 1 study-related diagnostic imaging procedure.|||participants|||Number
1415127|NCT01137578|Secondary|Number of Participants With Adjudicated Pulmonary Embolism (PE) Events (Symptomatic or Asymptomatic) Identified During the Study|Signs and symptoms of PE include shortness of breath, pleuritic pain, cough, orthopnea, wheezing, and may have associated signs and symptoms of DVT. In the event a PE was detected while undergoing the study MRI or other imaging procedure required for care of an underlying condition, and the participant did not manifest any signs and/or symptoms of a PE, the event was considered an asymptomatic PE. The participant was managed and further investigated according to the investigator’s standard of care. All diagnostic imaging procedures performed, such as contrast-enhanced computer tomography (CT) pulmonary angiogram, nuclear ventilation perfusion lung scan (V/Q scan), were submitted for adjudication as a suspected PE.|Enrollment up to Visit 1 plus 30 days (up to approximately 90 days)|The imaged population included all enrolled participants who had at least one study-related diagnostic imaging procedure.|||participants|||Number
1415128|NCT01137578|Secondary|Number of All Participants Identified With Adjudicated DVT Categorized By Presence or Absence of Symptoms at Enrollment|Adjudication was by an ICAC consisting of experienced physicians not involved in the study and blinded to each participant’s identity and clinical course. One set of Study-related diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Participants were considered positive for DVT if at least one of the radiographic procedures was positive.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|All participants who had an adjudicated DVT identified by at lest one study-related radiographic procedure.|||Participants|||Number
1415129|NCT01137578|Primary|Number of Participants Who Completed the Study-Related Ultrasound and Magnetic Resonance Imaging (MRI) With and Without Contrast, by Cohort and Age Group|Imaging was performed on Visit 1 which was defined for Cohort A as: Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 defined for Cohort B: within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI. All 3 imaging procedures, ultrasound, MRI with contrast, MRI without contrast were to be performed on all participants, regardless of the cohort.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C)|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.|||participants|||Number
1415130|NCT01137578|Primary|Total Number of Participants Who Completed the Study-Related Ultrasound (US) and Magnetic Resonance Imaging (MRI) With and Without Contrast|One set of 3 diagnostic imaging procedures (US, MRI with contrast, and MRI without contrast) was performed for all cohorts. Imaging was performed on Visit 1, which in Cohort A was Day 40 ± 20 days from Day 0, the placement of the central venous catheter (CVC), or if possible within 72 hours after a CVC was removed or lost; Visit 1 in Cohort B was within 7 days of initiation of symptoms of a CVC-related deep vein thromboembolism (DVT) or within 7 days of an incidental diagnosis of CVC-related DVT by radiographic imaging. Cohort C participants had an ultrasound done within 48 hours of the performance of the MRI, which was scheduled for a clinical reason. Note: participants completing each MRI procedure (with contrast or without contrast) could be different participants.|Either Day 40±20 days following the placement of CVC (cohort A) or within 7 days of: symptoms of DVT or incidental diagnosis of CVC-related DVT(cohort B) or Day of MRI + 48 hours (cohort C).|The imaged population included all enrolled participants who had at least 1 study-related diagnostic imaging procedure.|||participants|||Number
1415131|NCT01137539|Secondary|Patient Satisfaction|Positive response to a satisfaction question|12 months|49 subjects were analyzed at the 12 month period out of the total 50 subjects enrolled in the study.|||Participants|||Count of Participants
1415132|NCT01137539|Primary|Treatment Success Based on Patient Report on Validated Questionnaire|"Negative response to question #3 on the Urogenital Distress Inventory-6 (UDI-6) questionnaire. Question #3 states, Do you currently experience urine leakage related to physical activity, coughing or sneezing. If a subject answers No, this is considered success. If a subject answers Yes, this is considered failure of treatment."|24 months|46 subjects were analyzed at the 24 month period out of the total 50 subjects enrolled in the study.|||Participants|||Count of Participants
1415143|NCT01137396|Secondary|Change in N3 (Slow-wave) Sleep Time||change from week 1 to week 2 of inpatient treatment||||minutes||Standard Error|Mean
1415133|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Serum Uric Acid Levels at Week 12|Central laboratory serum uric acid levels will be determined at the Enrollment, Day -28, Day 1, and at Week 4, 8, 12, and 13 visits. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mg/dL||Standard Error|Mean
1415134|NCT01137474|Secondary|Adjusted Mean Change in 24-Hour Ambulatory Diastolic Blood Pressure at Week 12 (Last Observation Carried Forward [LOCF])|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24 hours each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hour ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
1415135|NCT01137474|Secondary|Adjusted Mean Change From Baseline in Seated Diastolic Blood Pressure at Week 12|All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
1415136|NCT01137474|Secondary|Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure at Week 12 (Last Observation Carried Forward)|Ambulatory blood pressure monitoring was performed twice during the study, at baseline and at the end of study, for a duration of 24-hrs each time. If the patient met the criteria for rescue due to hypertension, a second monitoring was performed prior to the first dose of rescue medication. Initiation of the 24-hr ambulatory blood pressure monitoring began between 6 and 11 am to ensure trough blood pressure measurements were obtained. Patients were instructed to withhold all medication on the morning of the study visit and to bring their medications to the visit with them.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
1415137|NCT01137474|Primary|Adjusted Mean Change From Baseline in Hemoglobin (HbA1c) at Week 12|HbA1c was measured as percent of hemoglobin by a central laboratory. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||Percent||Standard Error|Mean
1415138|NCT01137474|Primary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (BP) at Week 12|Seated BP was to be measured at every visit. Data after rescue medication was excluded. The patient first rested for at least 10 minutes in the seated position. Seated blood BP was determined from the mean of 3 replicated measurements obtained at least 1 minute apart. However, if the 3 consecutive seated BP readings were not within 8 mm Hg of each other, an additional 2 BP readings were to be obtained (total=5) and incorporated into the calculated mean for systolic BP and diastolic BP. For the initial BP recording, BP was measured in both arms. If the BP was higher in 1 arm, that arm was used for BP measurement. If there was no difference in BP measurements between arms, the dominant arm was used for all future BP measurements. All randomized participants who received at least 1 dose of study drug and who had nonmissing baseline and at least 1 postbaseline value during the double-blind treatment period were used for analysis. SD=standard deviation.|From Baseline to Week 12|This study originally had 2 additional arms-dapagliflozin 2.5 and 5 mg-but randomization to these arms stopped when Protocol Amendment 8 (1-11-11) was implemented. Because endpoints focused only on 10-mg and placebo data, only patients in these arms who received study drug and who had nonmissing baseline and Week 12 values were included.|||mm Hg||Standard Error|Mean
1415139|NCT01137435|Other Pre-specified|Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™|"Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.~All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period."|7 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Number of Events|||Number
1415140|NCT01137435|Other Pre-specified|Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™|All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Participants|||Number
1415141|NCT01137435|Other Pre-specified|Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™|Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.|30 days post-vaccination|Safety events were assessed in the Safety Analysis Set.|||Participants|||Number
1415144|NCT01137396|Primary|%Cocaine Free Urines||3x/week||||percent||Standard Error|Mean
1415148|NCT01137292|Primary|Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit|Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.|up to 2 weeks (EOT visit)|FAS. Number or participants analyzed = Number of participants with Investigator’s satisfaction response for the efficacy of voriconazole at the EOT Visit.|||participants|||Number
1415149|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|more than 2 weeks (Test-of-Cure visit)|FAS.|||participants|||Number
1415150|NCT01137292|Primary|Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit|Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.|up to 2 weeks (EOT visit)|Full Analysis Set (FAS) = all enrolled participants who were administered the study medication and had post baseline documentation of efficacy available.|||participants|||Number
1415151|NCT01137071|Secondary|Two-year Overall Survival: Median Time to Death|Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.|Within the ITT population, 7 patients died and 22 were censored. The median time to death was 25.1 months (95% CI, 16.7 to 32.4 months).|||months||95% Confidence Interval|Median
1415152|NCT01137071|Secondary|Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)|Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.|Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9|PK samples were analyzed from 10 patients. Dose: 30 mg/m2 every two weeks|||(µg/mL)||Standard Deviation|Mean
1415153|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415154|NCT01137071|Secondary|Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders|A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient’s hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415155|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415156|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415157|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415158|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415159|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415160|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415161|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415162|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415163|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415164|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415165|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)|The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415166|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415205|NCT01137071|Secondary|Safety - Vital Signs - Heart Rate|Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.|Baseline, week 2 , week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14|||bpm||Standard Deviation|Median
1416011|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at the End of Treatment||56 Days||||percentage of participants|||Number
1415167|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415168|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415169|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415170|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415171|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415172|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415173|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415174|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415175|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415206|NCT01137071|Secondary|Two-year Overall Survival Rate|Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.|2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.|Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.|||percentage of participants|||Number
1415176|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415177|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415178|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415179|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415180|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415181|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415182|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415183|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415184|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415207|NCT01137071|Secondary|1-year Disease Progression-free Survival Rate||1 year from the beginning of platinum-based rescue chemotherapy start date|In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.|||percentage of participants|||Number
1415185|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415186|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415187|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415188|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415189|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415190|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Vascular Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415191|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415192|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415193|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415264|NCT01136746|Secondary|Mean Plasma Glucose (MPG) by Hospital Day|The intent was to report results up to Day 10; however, due to low enrollment, mean and standard deviations are only reported up to Day 7.|Day 1 up to day 7 of hospital study period|All randomized participants who had at least one post-baseline glucose measurement and a plasma glucose measurement at specified timepoint.|||mg/dL||Standard Deviation|Mean
1416012|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at Week 8||56 Days|Participants with available data at Week 8.|||percentage of participants|||Number
1415194|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415195|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415196|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Investigations|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415197|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Nervous System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415198|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Immune System Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415199|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415200|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415201|NCT01137071|Secondary|Incidence of Adverse Events (AEs) - Gastrointestinal Disorders|The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.|From the first infusion of medication to 30 days after the last one|All patients who received at least one dose of investigational product were included in the safety dataset.|||Incidence|||Number
1415202|NCT01137071|Secondary|Safety - Vital Signs - Temperature|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14|||°C||Standard Deviation|Median
1415203|NCT01137071|Secondary|Safety - Vital Signs - Systolic and Diastolic Blood Pressure|Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14|||mmHg||Standard Deviation|Median
1415204|NCT01137071|Secondary|Safety - Vital Signs - Respiratory Rate|Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.|Baseline, week 2, week 4 and week 27|All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14|||ipm (Incursions per minute)||Standard Deviation|Median
1416013|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 4.0 – 5.1 mEq/L at Week 4||28 Days|Participants with available data at Week 4.|||percentage of participants|||Number
1415208|NCT01137071|Primary|1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy|"PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.~Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented."|1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.|In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).|||Months||95% Confidence Interval|Median
1415209|NCT01137032|Secondary|and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.||22 days|15 subjects represents the subgroup utilized for the analysis of this endpoint.|||participants|||Number
1415210|NCT01137032|Secondary|Pre-injection Serum Cortisol Levels|The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.|||participants|||Number
1415211|NCT01137032|Primary|Post-injection Serum Cortisol Level|The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.|22 Days|15 subjects represents the subgroup utilized for the analysis of this endpoint.|||participants|||Number
1415212|NCT01136967|Secondary|Pharmacokinetics and Pharmacodynamics|Due to the sparse PK sampling in this study, the data were pooled with data from other Phase 1 studies conducted in participants with solid tumors.|Predose and 2 to 12 hours postdose at Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1|||||||
1415213|NCT01136967|Secondary|Number of Participants With Adverse Events (AEs)/ Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, electrocardiograms (ECGs), and multi-gated acquisition (MUGA) scans or echocardiogram.|For each participant, from the first patient first dose till 30 days after the last dose of study drug, up to approximately 2.9 years|Safety Analysis Set included those participants who received at least 1 dose of study drug and had at least 1 post baseline safety evaluation.|||Participants|||Number
1415214|NCT01136967|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who had a BOR of CR or PR or durable SD (SD lasting greater than or equal to 23 weeks) based on IRR and Investigator's assessment. CBR = CR + PR + durable SD rate|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Percentage of participants||95% Confidence Interval|Number
1415215|NCT01136967|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in each cohort who had a best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review (IRR). A BOR of CR required confirmation by a subsequent CR assessment at least 4 weeks later. A BOR of PR required confirmation by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.|From date of first dose of study drug until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to end of Cycle 6 by the date of data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) included all participants who received at least 1 dose study drug.|||Percentage of participants||95% Confidence Interval|Number
1415216|NCT01136967|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had a BOR of CR or PR or stable disease (SD). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD needed to be greater than or equal to seven weeks based on IRR and Investigator's assessment. DCR = CR + PR + SD|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Percentage of participants||95% Confidence Interval|Number
1415217|NCT01136967|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date for each cohort.|From date of first dose of study drug until date of death from any cause or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Months||95% Confidence Interval|Median
1415218|NCT01136967|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death from any cause (whichever occurred first), as determined by IRR and Investigator based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (Jan 2012 and Apr 2013 for Cohort 1 and Cohort 2, respectively), up to approximately 2.9 years|Full Analysis Set (ITT Analysis Set) included all participants who received at least 1 dose study drug.|||Months||95% Confidence Interval|Median
1416014|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 – 5.5 mEq/L at Week 8||56 Days|Participants with available data at Week 8.|||percentage of participants|||Number
1415219|NCT01136954|Secondary|Median Percent Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period. Percentage change = 100% x (seizure frequency at period - seizure frequency at Study 312 baseline)/seizure frequency at Study 312 baseline.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population|||Percentage Change||Full Range|Median
1415220|NCT01136954|Secondary|Median Change From Study 312 Baseline in the 28-day Seizure Frequency During the Open Label Period|Participants' parent or guardian maintained a seizure diary recording the date, number, and type of seizures the subject had. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed from baseline of study 312 through the Open Label Visit Period.|Baseline of study 312 (Week -8 to Week 0) to Week 59 of study 313|Safety Population|||Seizures||Full Range|Median
1415221|NCT01136954|Secondary|Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Open Label Period|A participant with a decrease from baseline in seizure frequency of =50 % was considered a responder. Participants'parent or guardian maintained a seizure diary recording the date,number, and type of seizures the subject had. The primary analysis assessed the percent of responders from baseline in the Open Label Visit Period. Seizure frequency of simple partial, complex partial, and partial seizures with secondary generalization were assessed.|Baseline through Week 59|Safety Population|||Percentage of Participants|||Number
1415222|NCT01136954|Primary|Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency|Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event with a start date on or after Day 1 and within 15 days of last dose. For each event, each participant experiencing an event is only counted once even if they had multiple episodes.|Week 1 through Week 59|Safety Population (all subjects who entered the study and received at least one dose of study drug)|||Participants|||Number
1415223|NCT01136915|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2,4,6,24, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1415224|NCT01136876|Primary|Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media|Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.|Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1415225|NCT01136798|Secondary|Mean 24-h Blood Glucose Levels|Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.|baseline and after 6 weeks of treatment||||mg/dl||Standard Deviation|Mean
1415226|NCT01136798|Secondary|Severity of Obstructive Sleep Apnea|The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales.|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1415227|NCT01136798|Secondary|Minutes of Wake After Sleep Onset During Sleep Recording|total amount of time spent awake after sleep onset and before morning awakening will be calculated|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||minutes||Standard Deviation|Mean
1415228|NCT01136798|Secondary|Sleep Efficiency During Polysomnographic Recording|Sleep efficiency will be calculated as total sleep time over total recording time.|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||percentage of total recording time||Standard Deviation|Mean
1415229|NCT01136798|Primary|Total Amount of Slow Wave Activity|Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured|baseline and after 6 weeks of treatment|The second primary outcome measure, slow-wave activity (SWA) was not collected.||||||
1415230|NCT01136798|Primary|Non-REM Slow Wave Sleep|Total minutes of non-REM sleep was measured|baseline and after 6 weeks of treatment|The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.|||minutes||Standard Deviation|Mean
1415231|NCT01136785|Secondary|Change in 24-h Mean Level of Plasma Norepinephrine|The mean plasma norepinephrine level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean norepinephine level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory||||pg/ml||95% Confidence Interval|Mean
1415313|NCT01136174|Secondary|Change From Baseline in Pulse Rate|Change from baseline in pulse rate at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||bpm||Standard Deviation|Mean
1415232|NCT01136785|Secondary|24-hr Profile of Plasma Growth Hormone|The mean plasma growth hormone level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory||||ng/ml||95% Confidence Interval|Mean
1415233|NCT01136785|Secondary|Change in Mean Plasma Cortisol Level From 24-h Sampling|The mean plasma cortisol level will be calculated for all samples collected at baseline and for all samples collected at the end of the intervention in participants randomized to the active CPAP arm. The goal of the analysis of cortisol, growth hormone and norepinephrine levels was to explore putative mechanisms underlying the effects of active CPAP therapy. Examining putative hormonal mechanisms underlying changes in glucose levels in the sham CPAP arm was not part of our aims. For each participant, the change in mean cortisol level from baseline to end of intervention will be calculated.|after 1 week of active CPAP therapy in the laboratory||||microgram/dL||95% Confidence Interval|Mean
1415234|NCT01136785|Primary|Change in Mean Serum Insulin Derived From 24 Hour Blood Sampling|Serum insulin levels will be measured on each sample collected during 24-h sampling at baseline and at the end of the 7-day intervention. Mean insulin level over 24 hours will be calculated for each participant at baseline and at the end of the intervention. For each participant, we will calculate the change in mean insulin level from baseline.|after 1 week of therapy in the laboratory||||pmol/L||Standard Error|Mean
1415235|NCT01136785|Primary|Change From Baseline in Mean Glucose From Continuous Interstitial Glucose Monitoring Over 36-40 Hours|Continuous Glucose monitoring will provide interstitial glucose levels for 36-40 hours at baseline and after one week of active or sham CPAP therapy. The mean glucose level of all samples collected at baseline will be calculated for each participant. The mean glucose level of all samples collected at the end of the 7-day intervention will be calculated for each participant. For each participant, we will calculate the change in mean glucose level from baseline till end of the intervention.|change in mean interstitial glucose after 1 week of active or sham CPAP therapy in the laboratory|Due to sensor failures, valid profiles of interstitial glucose were available in 10 participants with the active CPAP group and 4 participants in the sham CPAP group.|||mg/dL||Standard Error|Mean
1415236|NCT01136785|Primary|Change From Baseline to End of 7-day Intervention in Mean Plasma Glucose Derived From 24 Hour Blood Sampling|24 hour blood sampling will be performed at baseline and at the end of the 7-day intervention. Glucose levels will be measured on each sample. Mean glucose level for all baseline samples will be calculated for each participant. Mean glucose levels for all samples collected at the end of the intervention will be calculated. Change in mean glucose level from baseline to end of intervention will be calculated for each participant.|after 1 week of CPAP therapy in the laboratory||||mg/dl||Standard Error|Mean
1415237|NCT01136772|Secondary|Changes in Psychiatric Symptoms|The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.|Baseline to 6 months|Participants with PANSS scores at 6 months|||Units on a scale||95% Confidence Interval|Mean
1415238|NCT01136772|Primary|Efficacy Failure|Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.|24 months|All randomized participants who received an injection and attended one follow-up appointment|||participants|||Number
1415239|NCT01136746|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|MACE was defined as the composite of all-cause death, nonfatal myocardial infarction (MI), or nonfatal stroke. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415240|NCT01136746|Secondary|Percentage of Participants With Documented Nosocomial Infections|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415241|NCT01136746|Secondary|Percentage of Participants With Deterioration of Renal Function Throughout the Hospital Study Period|Deterioration of renal function was defined by an increase in serum creatinine by >0.5 milligrams per deciliter (mg/dL). Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415242|NCT01136746|Secondary|Percentage of Participants Requiring Intensive Care Unit Transfer|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415243|NCT01136746|Secondary|Number of Participants With Treatment-emergent Adverse Events Throughout Hospital Study Period|Treatment-emergent adverse event – any untoward medical occurrence that either occurred or worsened at any time after treatment baseline and which did not necessarily have a causal relationship with this treatment. A summary of adverse events is located in the Reported Adverse Event Module.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants|||participants|||Number
1415244|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1416015|NCT01130597|Secondary|Percentage of Participants With Serum Potassium in the Range of 3.5 – 5.5 mEq/L at Week 4||28 Days|Participants with available data at Week 4.|||percentage of participants|||Number
1415245|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, by Hospital Day|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415246|NCT01136746|Secondary|Number of Hypoglycemia and Severe Hypoglycemia Episodes Adjusted for 30 Days (Rate), Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL, even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose. Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415247|NCT01136746|Secondary|Number (Incidence) of Hypoglycemia and Severe Hypoglycemia Episodes, Throughout Hospital Study Period|Hypoglycemia was defined as any time a recorded capillary PG level is ≤70 mg/dL, even if it is not associated with signs or symptoms, or treatment consistent with current guidelines (ADA 2005; ADA 2010). Severe hypoglycemia was defined as an episode associated with a recorded capillary (or venous) PG <40 mg/dL (Umpierrez et al. 2007; Moghissi et al. 2009; Umpierrez et al. 2009), even if it is not associated with need for assistance or neuroglycopenic symptoms (ADA 2005) or prompt recovery after oral carbohydrate, glucagon, or IV glucose.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.|||hypoglycemic episodes|||Number
1415248|NCT01136746|Secondary|Length of Hospital Stay Post-randomization Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415249|NCT01136746|Secondary|TDD of Insulin (Units/kg) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415250|NCT01136746|Secondary|TDD of Insulin (Units) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415251|NCT01136746|Secondary|TDD of Insulin (Units/kg) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415252|NCT01136746|Secondary|Total Daily Dose (TDD) of Insulin (Units) Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415253|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415254|NCT01136746|Secondary|Percentage of Capillary PG Measurements >240 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415255|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415256|NCT01136746|Secondary|Percentage of Participants Achieving Mean FPG Range of 71 to 139 mg/dL and Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415257|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415258|NCT01136746|Secondary|Percentage of Fasting Capillary PG Measurements Within the Range of 71 to 139 mg/dL and Within the Target of 100 to 139 mg/dL Throughout the Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout the hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415259|NCT01136746|Secondary|Mean FPG Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415260|NCT01136746|Secondary|Mean Fasting Plasma Glucose (FPG) by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415261|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1415262|NCT01136746|Secondary|Percentage of Participants Achieving MPG Within Range 71 to 179 mg/dL and Within the Target of 100 to 179 mg/dL Throughout Hospital Study Period|Due to low enrollment, this outcome measure was not analyzed.|Throughout hospital study period (1 to 10 days post-randomization)|Due to low enrollment, zero participants were analyzed.||||||
1415263|NCT01136746|Secondary|Percentage of Plasma Glucose Measurements Within Range 71 to 179 mg/dL by Hospital Day|Due to low enrollment, this outcome measure was not analyzed.|Day 1 up to day 10 of hospital study period|Due to low enrollment, zero participants were analyzed.||||||
1423970|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 2 hours after breakfast|2 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1415265|NCT01136746|Primary|Percentage of Capillary Plasma Glucose Measurements Within the Range of 71 to 179 mg/dL Throughout the Hospital Study Period|Results are reported as the percentage of total number of capillary plasma glucose measurements within the range of 71 to 179 mg/dL for each treatment arm.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.|||percentage of capillary PG measurements|Participants||Number
1415266|NCT01136746|Primary|Mean Plasma Glucose (MPG) Throughout Hospital Study Period|Overall MPG is derived as the mean of plasma glucose (PG) readings from Day/Visit 1 to Day/Visit 10.|Throughout hospital study period (1 to 10 days post-randomization)|All randomized participants who had at least one post-baseline glucose measurement.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1415267|NCT01136655|Secondary|Urinary Excretion of Formoterol During the 12 Hours Following Inhalation of Study Drug|The amount of formoterol excreted unchanged in urine over the 12-hour period after administration [Ae(0-12h)] was calculated from the concentration of formoterol in urine multiplied by the total volume of urine collected. Volume was determined from the weight of the collected urine times an assumed urine density of 1020 g/L. The data for six patients who did not have measurable formoterol in their urine on the Foradil 12 μg treatment day was excluded from the analysis. All other urine concentrations below the lower limit of quantification were set to zero. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|0 to 12 hours|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||pmol||95% Confidence Interval|Least Squares Mean
1415268|NCT01136655|Secondary|Maximal FEV1 During the 12-hour Study Period|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. The maximum FEV1 value was defined as the largest observed FEV1 value recorded during each 12-hour serial spirometry procedure. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1415269|NCT01136655|Secondary|FEV1 at 12 Hours After Study Medication Inhalation|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. The FEV1 value at 12 hours after dosing was taken as the 12-hour measurement (720 minutes) from the serial spirometry. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|12 hours after dosing|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1415270|NCT01136655|Primary|Average 12 Hour Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value is expressed in liters. One subject was incorrectly administered BUD 160/ formoterol (FM) 9.0 rather than BUD 160/ Foradil 12.0 at Period 4. Hence this subject is included in the Efficacy Analysis Set, but not the Safety Analysis Set for BUD 160/ Foradil 12.0.|at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes postdose|Efficacy analysis set including all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1415271|NCT01136486|Primary|Assessment of Pain Severity|Pain was assessed on a scale for 1 (no pain) to 10 (severe) pain. This is observational study so participants were only seen at one time point, when they were referred to the neuropsychology service.|Referral||||units on a scale||Standard Deviation|Mean
1415272|NCT01136408|Primary|Changes in Laboratory Test Values|The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range|12 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||participants|||Number
1415273|NCT01136408|Secondary|Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration||Week 1,4 and 12|Full Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1415274|NCT01136408|Secondary|Anticoagulation Effects Trough 11-dehydrothromboxane B2|Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients.|Week 0 and 12|Per Protocol Analysis Set|||pg/mg creatinine||Geometric Coefficient of Variation|Geometric Mean
1415275|NCT01136408|Secondary|Anticoagulation Effects Trough INR (International Normalised Ratio)|The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set|||ratio||Geometric Coefficient of Variation|Geometric Mean
1415276|NCT01136408|Secondary|Anticoagulation Effects Trough ECT (Ecarin Clotting Time)|The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.|Week 0,1,4 and 12|Full Analysis Set|||seconds||Geometric Coefficient of Variation|Geometric Mean
1415278|NCT01136408|Primary|Discontinuation of the Study Drug Due to Adverse Events|Discontinuation of the study drug due to adverse events.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||participants|||Number
1415279|NCT01136408|Primary|Incidence and Severity of Adverse Events|Intensity of event is categorised as mild, moderate and severe.|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||participants|||Number
1415280|NCT01136408|Secondary|Frequency (Occurrence Rates) of Death|The percentage of patients with death|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415281|NCT01136408|Secondary|Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events|The percentage of patients with other major adverse cardiac events|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415282|NCT01136408|Secondary|Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)|The percentage of patients with myocardial infarction (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415283|NCT01136408|Secondary|Frequency (Occurrence Rates) of Systemic Embolism|The percentage of patients with systemic embolism|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415284|NCT01136408|Secondary|Frequency (Occurrence Rates) of Transient Ischemic Attack|The percentage of patients with transient ischemic attack|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415285|NCT01136408|Secondary|Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)|The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415286|NCT01136408|Secondary|Frequency (Occurrence Rates) of a Composite Clinical Endpoint.|Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death)|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415287|NCT01136408|Primary|Frequency (Occurrence Rates) of Nuisance Bleeding Event|"The percentage of patients with nuisance bleeding event~Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator"|Upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415288|NCT01136408|Primary|Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event|"The percentage of patients with clinically relevant bleeding event.~Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:~A skin haematoma of at least 25 sqcm~Spontaneous nose bleed lasting for more than 5 minutes~Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)~Spontaneous rectal bleeding (more than spotting on toilet paper)~Gingival bleeding lasting for more than 5 minutes~Bleeding leading to hospitalisation~Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)~Any other bleeding considered clinically relevant by the investigator"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1416016|NCT01130597|Primary|Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment||56 days||||percentage of participants|||Number
1415289|NCT01136408|Primary|Frequency (Occurrence Rates) of Major Bleeding Event|"The percentage of patients with major bleeding event.~Major bleeding was defined as any bleed fulfilling one of the following conditions:~Fatal or life-threatening~Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)~Bleeding requiring surgical treatment~Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more~Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL"|upto 15 weeks|Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.|||Percentage of patients|||Number
1415290|NCT01136382|Secondary|Number of Withdrawals Due to Pre-defined Asthma Events|Patients were considered to have experienced a “pre-defined asthma event” if any of the following conditions were met during the study: 1. At each visit or follow-up visit, a decrease in morning pre-dose FEV1 >=20% from the Visit 3 (randomization visit) morning pre-dose FEV1 or a decrease to <65% of predicted normal value; 2. The use of >=8 actuations of albuterol/salbutamol per day on 3 or more days within any period of 7 consecutive days following randomization; 3. A decrease in morning PEF >=20% from baseline on 3 or more days within any period of 7 consecutive days after randomization; 4. Two or more nights with an awakening due to asthma, which required the use of reliever medication within any period of 7 consecutive days after randomization; 5. A clinical exacerbation requiring emergency treatment, hospitalization, or use of an asthma medication not allowed by the study protocol.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||participants|||Number
1415291|NCT01136382|Secondary|Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average|The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||inhalations per day||Standard Error|Least Squares Mean
1415292|NCT01136382|Secondary|Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average|The patient, with the help of their caregiver, recorded the number of inhalations of reliever medication used, for relief of asthma symptoms, twice daily in the eDiary. Patients were asked to respond to a standard question twice daily (morning and evening). The question to be answered was, “How many albuterol/salbutamol inhalations since last diary entry?”|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||inhalations per day||Standard Error|Least Squares Mean
1415293|NCT01136382|Secondary|Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were asked to respond to a standard question each morning as they completed their eDiary. The question to be answered was, “Did your asthma cause you to wake-up last night?” If yes, patients were asked, “Did you need to use your reliever medication (albuterol/salbutamol inhaler) before you went back to sleep?” Baseline is defined as the percentage of days where patient experienced nighttime awakenings out of all available days where data was collected during the last 7 days of the run-in period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||percentage of days with awakenings||Standard Error|Least Squares Mean
1415294|NCT01136382|Secondary|Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
1415295|NCT01136382|Secondary|Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average|Patients, with the help of their caregiver, were required to rate and document their asthma symptoms twice daily as an overall symptom score for the time period since their previous recording. The following rating scales were used: 0 = None; no symptoms of asthma; 1 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated; 2 = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep; 3 = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||units on a scale||Standard Error|Least Squares Mean
1415296|NCT01136382|Secondary|Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average|FEF25-75 is the average rate of airflow during the midportion of the forced vital capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters/second||Standard Error|Least Squares Mean
1415314|NCT01136174|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||mmHg||Standard Deviation|Mean
1415297|NCT01136382|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average|FVC is the total volume of air expired after a full inspiration. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1415298|NCT01136382|Secondary|Change in Evening PEF From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters/minute||Standard Error|Least Squares Mean
1415299|NCT01136382|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average|FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Baseline was defined as the pre-dose assessment value measured at randomization (Visit 3), and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters||Standard Error|Least Squares Mean
1415300|NCT01136382|Primary|Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average|The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.|Baseline to 6 weeks|The efficacy analysis set consisted of all patients who were randomized, received at least 1 dose of study medication, and contributed data for at least 1 efficacy endpoint.|||liters/minute||Standard Error|Least Squares Mean
1415301|NCT01136356|Secondary|Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine.|Average mean peak sleep assessed once a week for up to 8 weeks||||units on a scale||Standard Error|Mean
1415302|NCT01136356|Secondary|Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)|"Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being None to 100 being Extremely. The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine."|Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period||||units on a scale||Full Range|Mean
1415303|NCT01136356|Primary|Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)|Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.|Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days||||units on a scale||Full Range|Mean
1415304|NCT01136291|Secondary|Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)|All pregnant women responded to the quality of life WHOQOL-bref questionnaire, at study inclusion and at the completion of 36 gestational weeks. The domains of these questionnaires were calculated on a scale of zero (the worse quality of life) to 100 points (the better quality of life).|at the 14 and at the 40 gestational weeks||||scores on a scale||Standard Deviation|Mean
1415305|NCT01136291|Primary|Weight Gain During the Program|Weight gain during the program was the difference between the weight measured at study entry and final consultation weight, measured by a mechanical scale, in kilos and grams|at the 14 to 40 gestational weeks||||kg||Standard Deviation|Mean
1415306|NCT01136291|Primary|Gestational Weight Gain|Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy|baseline and at 40 gestational weeks||||kg||Standard Deviation|Mean
1415307|NCT01136226|Primary|Serum Testosterone Recovery|To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer|6 mos||||Months||Full Range|Mean
1415308|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC)|Change in Forced Vital Capacity percent of predicted (%FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||% predicted||Standard Deviation|Mean
1415309|NCT01136174|Secondary|Lung Function Measurement: Forced Vital Capacity (FVC)|Change in forced vital capacity (FVC) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||Liter||Standard Deviation|Mean
1415310|NCT01136174|Secondary|Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1)|Change in forced expiratory volume in 1 second (FEV1) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set|||Liter||Standard Deviation|Mean
1415311|NCT01136174|Secondary|Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco)|Change in Diffusing Capacity for Carbon Monoxide percent of predicted (%DLco) from baseline to day 35. Only the results for placebo and Nintedanib 150mg arm were reported for this endpoint as nintedanib 150mg is the target dose.|baseline and day 35|Treated set- Only patients with valid measurements were analysed.|||% predicted||Standard Deviation|Mean
1415316|NCT01136174|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background|Number of patients with Clinical Relevant Abnormalities in laboratory parameters reported as adverse events - No pirfenidone background|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
1415317|NCT01136174|Secondary|Withdrawal Due to Adverse Event|Number of patients prematurely discontinued from trial medication due to adverse event.|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
1415318|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1415319|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after lunch) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1415320|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg Without BIBF 1120 (after lunch)|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1415321|NCT01136174|Secondary|AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch)|AUC0-8,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 8 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after lunch) in the time frame mentioned.|Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1415322|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast)|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1415323|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg with BIBF 1120 (after breakfast) in the time frame mentioned.|Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1415324|NCT01136174|Secondary|Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast)|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set-Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1415325|NCT01136174|Secondary|AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast)|AUC0-4,ss was calculated as the area under the curve of the concentration-time profile of the analyte in plasma at steady state over the time interval from 0 to 4 hours after multiple doses of Pirfenidone 600 mg without BIBF 1120 (after breakfast) in the time frame mentioned.|Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1415326|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1415346|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||mcg/mL||Standard Deviation|Mean
1423971|NCT01064739|Secondary|Plasma Dopamine|Plasma dopamine 1 hour after breakfast|1 hour after breakfast||||pg/mL||Standard Deviation|Mean
1415327|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 With Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 with pirfenidone in the time frame mentioned.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1415328|NCT01136174|Secondary|Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"Maximum measured concentration of the analyte in plasma at steady state was identified from measurements obtained at multiple time points over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set- Only patients with valid final pharmacokinetic values were analysed|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1415329|NCT01136174|Secondary|AUCτ,ss After Multiple Doses of BIBF 1120 Without Pirfenidone|"AUCτ,ss was calculated as the area under the concentration-time curve of the concentration-time profile of the analyte in plasma at steady state over a uniform dosing interval τ after multiple doses of BIBF 1120 without pirfenidone in the time frame mentioned.~Detailed outcome measure time frame:~In 50 mg and 100 mg dose group:~BIBF 1120:~days 14 (-1, +3) to 17 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose~In 150 mg dose group:~BIBF 1120:~days 28 (-1, +3) to 31 at Visit 5: At pre-dose and 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose"|pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)|Treated set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1415330|NCT01136174|Primary|Drug-related Adverse Events|The number of patients with drug-related adverse events stratified according to pirfenidone use in each group|after the first drug intake until 28 days from the last treatment administration, up to 60 days|Treated set|||participants|||Number
1415331|NCT01135992|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator|||episodes per 100 patient years|||Number
1415332|NCT01135992|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.|||episodes per 100 patient years|||Number
1415333|NCT01135992|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject’s daily activities. Moderate AEs: marked symptoms, moderate interference with subject’s daily activities. Severe AEs: considerable interference with subject’s daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.|||events per 100 patient years|||Number
1415334|NCT01135992|Secondary|Change in Body Weight|Change from baseline in body weight after week 4 and after week 16|Week 0, Week 4, Week 16|Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using LOCF (last observation carried forward)|||kg||Standard Deviation|Mean
1415335|NCT01135992|Secondary|Fasting Plasma Glucose (FPG)|FPG at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment|||mmol/L||Standard Deviation|Mean
1415336|NCT01135992|Primary|HbA1c (Glycosylated Haemoglobin)|HbA1C at week 4 and 16|Week 4 and Week 16|FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1415337|NCT01135914|Secondary|Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12|(TTO) questionnaire was used to help determine the patients’ health utility. Reported health utility represents the patients’ quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision.|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included|||Units on a scale||Standard Deviation|Mean
1415338|NCT01135914|Secondary|EuroQoL (EQ-5D) Utility Score at Month 12|The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1=“no problems”, 2=”some problems” and 3=”extreme problems”. Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health).|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included|||Units on a scale||Standard Deviation|Mean
1415339|NCT01135914|Secondary|National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed|12 month|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included|||Units on a Scale||Standard Deviation|Mean
1415340|NCT01135914|Secondary|Percentage of Patients Achieving Gain of Letters From Baseline in BCVA|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement.|12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with 12 month data were included|||Percentage of Patients|||Number
1415341|NCT01135914|Secondary|Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response.|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT|||Percentage of Patients|||Number
1415342|NCT01135914|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12|OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment|Baseline, 3, 6, 9 and 12 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.|||um||Standard Deviation|Mean
1415343|NCT01135914|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline, 3, 6 and 9 months|The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.|||Letters||Standard Deviation|Mean
1415344|NCT01135914|Primary|Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|Baseline and 12 months|ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. patients with both baseline and 12 month data were included.|||Letters||Standard Deviation|Mean
1415345|NCT01135524|Primary|The Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.|52 weeks|The Extension Safety Population (N = 196) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.|||participants|||Number
1415447|NCT01135329|Secondary|Progression-free Survival|Percentage of participants alive without disease relapse or progression.|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
1456129|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|baseline||||inches||Standard Deviation|Mean
1415347|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||mcg/mL||Standard Deviation|Mean
1415348|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||Relative unit/mL||Standard Deviation|Mean
1415349|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of Intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||Relative unit/mL||Standard Deviation|Mean
1415350|NCT01135511|Other Pre-specified|Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4|"Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 4 and 8|A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.|||Participants|||Number
1415351|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||Relative unit/mL||Standard Deviation|Mean
1415352|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||mcg/mL||Standard Deviation|Mean
1415353|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415354|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
1415355|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415356|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415357|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415358|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415359|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415360|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
1415361|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415362|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
1415363|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
1415364|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
1415365|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415366|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415367|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415368|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1423972|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 6 hours after breakfast|6 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1415369|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415370|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415371|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415372|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||pg/mL||Standard Deviation|Mean
1415373|NCT01135511|Other Pre-specified|Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3|"Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change= value at visit minus value at baseline."|Baseline, Week 4 and 8|"A subset of intent-to-treat population collected tear samples from both eyes at baseline, week 4 and week 8.~n=number of analyzed with sufficient quantity for testing."|||ng/mL||Standard Deviation|Mean
1415374|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye|"Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.|||Percentage of positive cells||Standard Deviation|Mean
1415375|NCT01135511|Other Pre-specified|Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye|"The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC).~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = value at observation minus value at baseline."|Baseline, Week 4 and 8|A subset of intent-to-treat population collected impression cytology samples from both eyes at screening, week 4 and week 8.|||Antibodies bound per cell||Standard Deviation|Mean
1415376|NCT01135511|Secondary|Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale|"Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.|||Participants|||Number
1415377|NCT01135511|Secondary|Number of Participants With Nonocular Adverse Events (AEs) by Severity|Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.|||Participants|||Number
1415378|NCT01135511|Secondary|Number of Participants With Ocular Adverse Events (AEs)by Severity|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.|8 weeks|Safety analysis set: Participants who received at least 1 dose of study treatment.|||Participants|||Number
1415379|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores|The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Participants|||Number
1415380|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Participants|||Number
1415381|NCT01135511|Secondary|Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.~100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Participants|||Number
1415382|NCT01135511|Secondary|Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Percentage of participants|||Number
1415383|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1415384|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].~Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1415385|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1415386|NCT01135511|Secondary|Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline|"The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.~The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1415387|NCT01135511|Secondary|Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Participants|||Number
1415448|NCT01135329|Secondary|Overall Survival|Percentage of participants alive|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
1415388|NCT01135511|Secondary|Changes in the Ocular Comfort Index (OCI) Total Score From Baseline|"The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1415389|NCT01135511|Secondary|Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Participants|||Number
1415390|NCT01135511|Secondary|Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.|||Percentage of participants|||Number
1415391|NCT01135511|Secondary|Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline|"The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Millimeters||Standard Deviation|Mean
1415392|NCT01135511|Secondary|Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline|"TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: value at observation minus value at baseline. Positive change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Seconds||Standard Deviation|Mean
1415393|NCT01135511|Secondary|Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline|"Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1415394|NCT01135511|Secondary|Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye|"Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.~Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline."|Week 1, 2, 4 and 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data at Week 8.|||Percentage of participants|||Number
1415395|NCT01135511|Secondary|Changes in Corneal Staining Scores for Study Eye From Baseline|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 1, 2 and 4|Intent-to-treat population: Participants who received at least 1 dose of study treatment.|||Units on a scale||Standard Deviation|Mean
1415396|NCT01135511|Primary|Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8|"Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.~Change: score at observation minus score at baseline. Negative change from baseline indicated improvement."|Baseline, Week 8|Intent-to-treat population: Participants who received at least 1 dose of study treatment. A last observation carried forward (LOCF) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1415397|NCT01135498|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up.|From study start up to approximately 4 years|ITT population|||months||95% Confidence Interval|Median
1415398|NCT01135498|Primary|Progression-Free Survival|Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).|From study start up to approximately 4 years|ITT population|||months||95% Confidence Interval|Median
1415399|NCT01135498|Secondary|Percentage of Participants Who Died||From study start up to approximately 4 years|ITT population|||percentage of participants|||Number
1415400|NCT01135498|Secondary|Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])|Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.|From study start up to approximately 4 years|Response-Evaluable population|||percentage of participants|||Number
1415401|NCT01135498|Secondary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])|Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]) and no new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From study start up to approximately 4 years|Response-Evaluable population: all enrolled participants who received at least 3 cycles of treatment, had all baseline lesions evaluated at least once after receiving the third cycle (using same technique as at baseline), and were without major violations of the study protocol.|||percentage of participants|||Number
1415402|NCT01135498|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|Start of study to approximately 4 years|ITT population|||percentage of participants|||Number
1415403|NCT01135420|Primary|Readiness to Attend Substance Use Disorder Continuing Care|Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.|3 months post-intervention||||units on a scale||Standard Deviation|Mean
1415404|NCT01135381|Secondary|Community Tenure|The number of days a patient spends in the home versus the hospital at 30 days.|30 days||||days||Standard Deviation|Mean
1415405|NCT01135381|Secondary|Rehospitalizations at 90 Days||90 days||||participants|||Number
1415406|NCT01135381|Primary|Re-hospitalizations||During the 30days after discharge||||participants|||Number
1415407|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye|The macula lutea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415408|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye|The macula lutea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415409|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye|The retinal blood vessels of the left eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415449|NCT01135329|Primary|Chimerism in CD3+ Sorted Peripheral Blood|Percentage of participants achieving full-donor chimerism in CD3+ sorted peripheral blood|Day 60|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
1423973|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 4 hours after breakfast|4 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1415410|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye|The retinal blood vessels of the right eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415411|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye|The optic nerve and papilla of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415412|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye|The optic nerve and papilla of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415413|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye|The retinal aspect of the left eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415414|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye|The retinal aspect of the right eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415415|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye|"The vitreous body of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415416|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye|"The vitreous body of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415417|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye|"The lens of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415418|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye|"The lens of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415419|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye|The cornea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415420|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye|The cornea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415421|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Color Vision|Color vision was assessed by an Ophthalmologist and classified as normal or pathological. Pathological findings include abnormal color vision tests, color blindness and anomalous quotient. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in color vision classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415422|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Accommodation|Accommodation is the adjustment of the focal length of the eye lens to keep an object in focus on the retina as its distance from the eye varies, and is measured in diopters: Diopters = 1/(focal length).|Baseline and Year 5|Safety analysis where data were available. Last observation carried forward was utilized.|||diopters||Standard Deviation|Mean
1415423|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation With Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation with glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation with glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415424|NCT01135368|Secondary|Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare|"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation without glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation without glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)."|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||participants|||Number
1415425|NCT01135368|Secondary|Ophthalmologic Examination - Visual Acuity|Visual Acuity was measured using the Snellen eye chart at a distance of 6 meters. Acuity is expressed as a ratio of the test distance (6 M) / the distance the average eye can see the letters on a certain line of the eye chart. Visual acuity of 1 is normal; an individual with acuity of 0.5 could only recognize an object at half the distance compared to an individual with normal acuity.|Baseline and Year 5|Safety analysis set, where data were available. Last observation carried forward was utilized.|||ratio||Standard Deviation|Mean
1415426|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Follicle Stimulating Hormone|The change between follicle stimulating hormone (FSH) measured at year 5 in males including final visit and follicle stimulating hormone measured at baseline.|Baseline and Year 5.|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.|||IU/L||Standard Deviation|Mean
1415427|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Luteinizing Hormone|The change between luteinizing hormone measured at year 5 in males including final visit and luteinizing hormone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.|||IU/L||Standard Deviation|Mean
1415428|NCT01135368|Secondary|Change From Baseline in Blood Analysis - Testosterone|The change between testosterone measured at year 5 in males including final visit and Testosterone measured at baseline.|Baseline and Year 5|Safety analysis set, including all male participants who received any study medication. Last observation carried forward was utilized.|||µg/L||Standard Deviation|Mean
1415429|NCT01135368|Secondary|Change From Baseline in Corpus Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
1415430|NCT01135368|Secondary|Change From Baseline in Antrum Intestinal Metaplasia|Intestinal metaplasia was assessed by biopsy and histopathological examination of the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
1415431|NCT01135368|Secondary|Change From Baseline in Corpus Chronic Inflammation Score|Chronic inflammation of the corpus was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe.|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||scores on a scale||Standard Deviation|Mean
1415432|NCT01135368|Secondary|Change From Baseline in Average Antrum Chronic Inflammation Score|Chronic inflammation of the antrum was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||scores on a scale||Standard Deviation|Mean
1415450|NCT01135329|Primary|Chimerism in Unsorted Peripheral Blood|Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.|Day 60|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
1415433|NCT01135368|Secondary|Change From Baseline in Corpus Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
1415434|NCT01135368|Secondary|Change From Baseline in Antrum Atrophy|Atrophy was assessed by histopathological examination of cells biopsied from the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows).|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
1415435|NCT01135368|Secondary|Change From Baseline in Enterochromaffin-like Cell Hyperplasia|"Enterochromaffin-like (ECL) cells were evaluated and classified by histopathological examinations as Normal, Simple (diffuse) hyperplasia, or Linear, chain producing hyperplasia.~The shift table below summarizes the individual transitions in ECL-cell classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows) for all patients."|Baseline and Year 5|Safety analysis set, including all participants who received any study medication. Last observation carried forward was utilized.|||participants|||Number
1415436|NCT01135368|Primary|Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy|Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks >5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are <75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
1415437|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat|Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
1415438|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting|Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
1415439|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen|Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
1415440|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing|Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
1415441|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation|Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
1415442|NCT01135368|Primary|Change From Baseline in Reflux Disease Symptom - Heartburn|Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.|Baseline and Week 8|Intent to treat population, including all patients who received at least one dose of study medication and had a subsequent rating of the primary efficacy variable.|||participants|||Number
1415443|NCT01135329|Secondary|Graft Failure|Percentage of participants who failed to engraft.|Day 60||||Participants|||Count of Participants
1415444|NCT01135329|Secondary|Incidence of Graft-versus-host-disease (GVHD)|Percentage of participants experiencing acute and chronic GVHD. Acute GVHD is graded by Przepiorka criteria. Chronic GVHD is graded by NIH consensus criteria and Seattle criteria.|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
1415445|NCT01135329|Secondary|Non-relapse Mortality|Percentage of participants who died due to BMT-related reasons|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
1415446|NCT01135329|Secondary|Incidence of Relapse|Percentage of participants experiencing disease relapse or progression|1 year|The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.||||||
1415451|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Symptom Severity as Measured by the Patient Assessment of Gastrointestinal Disorder-Symptom Severity Index Disorders Symptom Severity Index (PAGI-SYM)|"Symptom severity as measured by the Patient Assessment of Upper Gastrointestinal Disorder- Symptom Severity Index. (PAGI-SYM)~The PAGI-SYM is compose of 20 questions.~Each question can be answered on a scale of 1-5 (below)~0 = none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe~Cumulative scores were calculated by summing all 20 questions.~The minimum cumulative scores would be 0 while the maximum cumulative score would be 100~Once we calculated the cumulative score for each participant, we took the average of all the cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.~Lower score indicates decreased symptom severity. Higher score indicates increased symptom severity."|Baseline, 4 Weeks, 8 Weeks||||units on a scale||Standard Deviation|Mean
1415452|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Quality of Life.|"Quality of life as impacted by patients with upper gastrointestinal disorders (PAGI-QOL)~The PAGI-QOl is composed of 30 questions.~Each question asks about the degree to which a patient’s quality of life is impacted by upper gastrointestinal disorders.~Questions measure quality of life impact on a scale of 1-5 listed below.~0=none of the time, 1=a little of the time, 2=some of the time, 3=a good bit of the time, 4= most of the time, 5= all of time~The 30 items are summed together for a cumulative PAGI-QOL score. The minimum cumulative score is “0” and the maximum score is “150.”~Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.~Lower scores indicate an improved overall quality of life. Higher scores indicate a diminished overall quality of life."|Baseline, 4 Weeks, 8 Weeks||||units on a scale||Standard Deviation|Mean
1415453|NCT01135186|Secondary|Secondary Outcome Measures Will Include Change in Symptom Severity.|"Change in symptom severity over the past 2 weeks as measured by the patient reported Gastroparesis Cardinal Symptom Index (GCSI)~The GCSI is composed of 9 questions.~Each question asks about symptom severity on a scale of 1-5 listed below.~0=None 1= Very mild 2= Mild 3=Moderate 4=Severe 5= Very severe~The 9 scores are summed together for cumulative GCSI score. The minimum cumulative score is ‘”0” and the maximum cumulative score is “45.”~Once we calculated the cumulative score for each participant, we took the average of all participants cumulative scores giving us the sample mean. This was done at baseline, week 4, and week 8.~Higher total scores indicate higher symptom severity. Lower total scores indicate lower symptom severity."|Baseline, 4 Weeks, 8 Weeks||||units on a scale||Standard Deviation|Mean
1415454|NCT01135186|Primary|Gastric Accommodation|"Gastric Accommodation refers to the reflexive relaxation of the upper stomach after swallowing as measured by the Satiety Test at baseline, 4 weeks, and 8 weeks.~Increased gastric accommodation is considered a positive outcome."|Baseline, 4 Weeks, 8 Weeks||||ml||Standard Deviation|Mean
1415455|NCT01135134|Secondary|Change From Baseline in the Total Nasal Symptom Score at 1 Week|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 1 week||||score on a scale||Standard Error|Least Squares Mean
1415456|NCT01135134|Primary|Change From Baseline in the Total Nasal Symptom Score at 2 Weeks|Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.|Baseline and 2 weeks (or discontinuation)||||score on a scale||Standard Error|Least Squares Mean
1415457|NCT01135069|Primary|Improvement in Acne|Counting of acne lesions both inflammatory and non-inflammatory|12 weeks||||Percent change||Standard Deviation|Mean
1415458|NCT01135017|Other Pre-specified|Overview of Adverse Events (AE)|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 10 days after the last study drug intake|All randomized and treated participants. Participants were considered according to the treatment actually received.|||participants|||Number
1415459|NCT01135017|Secondary|Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)|"Electrical cardioversion is a procedure in which an electric shock is used to restore normal heart rhythm. Overdrive pacing is a procedure in which an artificial cardiac pacemaker is used to increase the heart rate in order to suppress certain arrhythmias.~Incidence rate of electrical cardioversion (or overdrive pacing) is expressed as the number of participants that was cardioverted or paced during the study."|12 weeks|Modified intent-to-treat population as previously defined|||participants|||Number
1415460|NCT01135017|Secondary|Atrial Fibrillation Severity Scale (AFSS) Scores|"The University of Toronto Atrial Fibrillation Severity Scale is an instrument to assess the subject-perceived AF burden and AF symptom severity. It consists in a questionnaire plus a scoring algorithm.~AF Burden score ranges from 3 to 30 and higher scores indicate greater AF burden.~AF symptoms severity score ranges from 0 to 35 and higher scores indicate extremely severe AF symptoms."|Baseline (before randomization) and 12 weeks after randomization|Modified intent-to-treat population as previously defined|||units on a scale||Standard Deviation|Mean
1415461|NCT01135017|Secondary|Average Ventricular Rate During AF Episodes|"Ventricular rates of AF episodes were obtained from pacemaker interrogation and EGM review.~The average ventricular rate during AF episodes in the 12-week treatment period was defined as the duration-weighted average of the ventricular rates collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined|||beats/min||Standard Deviation|Mean
1415462|NCT01135017|Secondary|AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment|AF burden at each pacemaker interrogation as evaluated centrally by the Pacemaker Core Lab|4 weeks and 12 weeks after randomization|Modified intent-to-treat population as previously defined|||percent time in AF||95% Confidence Interval|Geometric Mean
1415532|NCT01134549|Secondary|Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||percentage of AUCINFobs||Standard Deviation|Mean
1415463|NCT01135017|Primary|Atrial Fibrillation (AF) Burden During the 12-week Treatment Period|"AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator.~AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing."|Baseline (before randomization), 4 weeks and 12 weeks after randomization|The analysis included all randomized and treated participants with post-baseline AF burden assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).|||percent time in AF||95% Confidence Interval|Geometric Mean
1415464|NCT01134952|Secondary|Delta Triglyceride Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available on 2 patients|||percent change||Standard Deviation|Mean
1415465|NCT01134952|Secondary|Delta Cholesterol Fasting Level|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available for 2 patients|||percent change||Standard Deviation|Mean
1415466|NCT01134952|Secondary|Delta Platelet Count|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available on 2 patients at appropriate time|||percent change||Standard Deviation|Mean
1415467|NCT01134952|Secondary|Delta Hemoglobin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate times not available in 2 patients|||percent change||Standard Deviation|Mean
1415468|NCT01134952|Secondary|Delta Alanine Aminotransferase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels at appropriate time not available in 2 patients|||percent change||Standard Deviation|Mean
1415469|NCT01134952|Secondary|Delta Alkaline Phosphatase|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels not available at appropriate times in 2 patients|||percent change||Standard Deviation|Mean
1415470|NCT01134952|Secondary|Delta Bilirubin|Percent change determined 3 months after switch from MMF to SRL|3 month|Levels available at correct time in only 7 patients|||percent change||Standard Deviation|Mean
1415471|NCT01134952|Secondary|Delta Tacrolimus Trough Level|Percent change determined 3 months after switch from MMF to SRL|3 month|2 patients did not have tacrolimus levels recorded during both time periods and are excluded|||percent change||Standard Deviation|Mean
1415472|NCT01134952|Secondary|Sirolimus Trough Level||3 month||||ng/ml||Standard Deviation|Mean
1415473|NCT01134952|Secondary|Final Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from SRL to MMF|3 month||||percent change||Standard Deviation|Mean
1415474|NCT01134952|Primary|Delta Hepatitis C Viral Load|Percent change in HCV load determined 3 months after switch from MMF to SRL.|3 month||||percent change||Standard Deviation|Mean
1415475|NCT01134939|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for haemoglobin at baseline and at month 36.|||g/dL||Standard Deviation|Mean
1415476|NCT01134939|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for creatinine at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1415477|NCT01134939|Secondary|Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.|||U/L||Standard Deviation|Mean
1415478|NCT01134939|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for the AST at baseline and at month 36.|||U/L||Standard Deviation|Mean
1415479|NCT01134939|Secondary|Changes in the Laboratory Data ( ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.|||U/L||Standard Deviation|Mean
1415480|NCT01134939|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for blood glucose at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1415481|NCT01134939|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for triglycerides at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1415482|NCT01134939|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for LDL cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1415483|NCT01134939|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for HDL cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1415484|NCT01134939|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data. .|Baseline and 36 months|Patients from TS with evaluable data for total cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1415485|NCT01134939|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.|||cells/mm^3||Standard Deviation|Mean
1415486|NCT01134939|Secondary|Changes in the Viral Load After 36 Months From Baseline|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.|||Log10 copies/mL||Standard Deviation|Mean
1415487|NCT01134939|Primary|Number of Patients With Virologic Response (VR) After 36 Months|"VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart.~A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml."|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.|||participants|||Number
1415488|NCT01134900|Secondary|Time to Provider Response|Time from study event to modification or discontinuation of targeted medication|Until patient discharge (~2 week average)||||Hours|Participants|Inter-Quartile Range|Median
1415489|NCT01134900|Primary|Adverse Drug Events or Potential Adverse Drug Events|Our primary outcome measured the rate of AKI-related ADEs and pADEs. We defined pADEs as incidents with the potential for injury related to a drug, such as use of a non-steroidal anti-inflammatory drug for at least 24 hours, and ADEs as injuries resulting from the administration of a drug, such as a toxic vancomycin trough level or a bleed after administration of enoxaparin. We measured outcomes after completion of the inpatient encounter (either by death or discharge); pADEs or ADEs occurring after patient discharge were not included in the analysis.|Until patient discharge (~2 week average)||||Patient-Medication Pairs|Participants||Number
1415490|NCT01134887|Primary|Patient Activation Measure|Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM). Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max). Rasch conversion changed raw scores to the PAM interval measure. Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up. If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score. Higher PAM scores represent higher levels of self-activation. Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence. Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2 (min) to 77 (max). Ranges for Follow-up PAM scores: Intervention = 48.4 (min) to 100 (max); Control = 45.1 (min) to 80.1 (max).|12 months|Veterans participating in CHOICE study randomized to two arms: intervention or attention control. The 13-item Patient Activation Measure was administered at baseline and up to two additional times during the following 12 months. Rasch conversion of the raw PAM scores was performed to ensure the final scores were linear and interval measures.|||units on a scale||Standard Deviation|Mean
1415491|NCT01134783|Secondary|Change in Weight From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||Kg||Standard Error|Mean
1415492|NCT01134783|Secondary|Change in BMI From Baseline to 12 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 12 months|Baseline to 12 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||kg/m2||Standard Error|Mean
1415493|NCT01134783|Secondary|Change in Weight From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in weight from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||Kg||Standard Error|Mean
1415533|NCT01134549|Secondary|Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||hr*μg/L||Standard Deviation|Mean
1415494|NCT01134783|Secondary|Change in BMI From Baseline to 4 Months|Comparison of the effects of the intervention and control groups with regard to change in BMI from baseline to 4 months|Baseline to 4 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||kg/m2||Standard Error|Mean
1415495|NCT01134783|Secondary|Prevalence of Overweight/Obese|The prevalence of overweight/obese between intervention and control students|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||percentage of participants|||Number
1415496|NCT01134783|Primary|Change in Body Mass Index (BMI)|The primary aim of this study is to examine the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students. Our hypothesis is that students randomized to an intervention condition will experience a smaller increase in mean BMI post treatment as compared to students randomized to the control condition.|Baseline to 24 Months|The original study design was 4 arms (1 control & 3 intervention) that varied in the way the 4-month curriculum was delivered. Our formative work showed that students not being able to choose the course delivery method would limit interest in study participation. We changed the study design to 2 arms, which was approved by the EARLY trials DSMB.|||kg/m2||Standard Error|Mean
1415497|NCT01134731|Secondary|Mean Score of Montgomery-Asberg Depression Scale of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Montgomery-Asberg Depression Rating Scale will be used to measure depressive symptoms to determine the efficacy of the study drugs. It has 10 items (subscales) ranging from 0-6. Therefore the total score ranges from 0-60, with lower scores indicating better outcomes. The subscales were summed for a total score.|baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1415498|NCT01134731|Primary|Mean Score of Beck Scale for Suicidal Ideation of Three Treatment Groups (Paliperidone, Lithium and Placebo) After 3 Months of Treatment|The Beck Scale for Suicidal Ideation will be used to measure the efficacy of the study drugs. The primary outcome measure is the Beck Suicide Scale Self Report. The primary outcome measure is the Beck Suicide Scale Self Report. It has 21 questions (subscales) with values ranging from 0-2. Therefore the total score ranges from 0-42, with lower scores indicating better outcomes. The subscales were summed to achieve a total score.|baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
1415499|NCT01134705|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.|Baseline and Week 6|The RQLQ population included adults (18 years and older) with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
1415500|NCT01134705|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
1415501|NCT01134705|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)|Intent-to-Treat (ITT) Population: The ITT population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1415502|NCT01134627|Other Pre-specified|Relapse Severity Based on Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5 and by at least 0.5 points if last EDSS was more than 5.5.|96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized to study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."|||Units on a scale||Standard Deviation|Mean
1415503|NCT01134627|Other Pre-specified|Number of Participants With Total Number of Reported Relapses (Documented and Undocumented Relapses)|Documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.|||participants|||Number
1419178|NCT01106157|Secondary|Change in Insulinoma Associated 2 Autoantibodies (IA-2A) From Baseline to 12 Months|Change in Insulinoma Associated 2 Autoantibodies (IA-2A)|Change from baseline to 12 months||||nmol/L||Standard Deviation|Mean
1415504|NCT01134627|Other Pre-specified|Number of Relapse Free Participants Without Progression|Analysis based on documented relapses (relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition; relapse documented by exacerbation >=1 point increase in 2 functional systems/2 points increase in 1 functional system, or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 [normal] to 10 [death due to MS]) and overall relapses (documented and undocumented relapses); undocumented relapses only fulfilled condition for relapse.|Baseline up to 96 weeks (+/- 1 week) or ET|"ITT population included all the participants who were randomized and received study medication. Number of participants analyzed N included those participants who were evaluated for this particular measure."|||participants|||Number
1415505|NCT01134627|Other Pre-specified|Relapse Count|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, persisting for more than 48 hours and with a previous period for more than 30 days with a stable or an improving condition.|Week 48 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of the measure and the study was prematurely terminated.||||||
1415506|NCT01134627|Other Pre-specified|Burden of Disease|The burden of disease (BOD) is the total area of MS lesions (abnormal plaques) in the brain measured on Time Constant 1 (T1) or T2 weighted MRI.|Baseline up to 96 weeks (+/- 1 week) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.|||square millimeter (mm^2)||Standard Deviation|Mean
1415507|NCT01134627|Other Pre-specified|Percentage of Time Constant 2 (T2) Active Scans Per Participant|Inflammatory disease activity was assessed by MRI measurement of the percentage of T2 active scans.|Baseline up to 96 weeks (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.||||||
1415508|NCT01134627|Other Pre-specified|Number of Time Constant 2 (T2) Active Lesions|Inflammatory disease activity was assessed by MRI measurement of the number of T2 active lesions.|Week 48 up to Week 96 (+/- 1 week) or ET|Data was not analyzed due to insufficient number of participants available for the analysis of this measure and the study was prematurely terminated.||||||
1415509|NCT01134627|Other Pre-specified|Number of Participants With Onset of Disability Progression|Disability progression was defined as an increase, compared to baseline evaluation of >= 1.0 points on EDSS if EDSS was >= 1.0 at baseline or >=1.5 point on EDSS if EDSS was 0.0 at baseline. EDSS assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.|||participants|||Number
1415510|NCT01134627|Secondary|Changes in Brain Volume Measured on Magnetic Resonance Imaging (MRI)|Changes in brain volume were measured as the brain parenchymal fraction using MRI scans.|Screening , final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.|||cubic millimeter (mm^3)||Standard Deviation|Mean
1415511|NCT01134627|Secondary|Number of New or Enlarging Lesions on Time Constant 2 (T2) Weighted Magnetic Resonance Imaging (MRI)|Inflammatory disease activity was assessed by MRI measurement of the number of new or enlarging T2 lesions.|Final visit (96 weeks [+/- 1 week]) or ET|Sub-group of ITT population included limited number of participants at pre-selected sites selected on basis of availability of MRI scanning facilities and the willingness of the site to participate.|||lesions||Standard Deviation|Mean
1415512|NCT01134627|Secondary|Number of Participants With Documented Relapses|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation was >=1 point increase in 2 functional systems /2 points increase in 1 system, either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on EDSS which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline up to 96 weeks (+/- 1 week) or ET|ITT population included all the participants who were randomized and received study medication.|||participants|||Number
1415513|NCT01134627|Primary|Number of Participants Who Experienced First Documented Relapse|Documented relapse: development of new/exacerbation of existing neurological symptoms, persisting for >48 hrs and with previous period for >30 days with stable/improving condition. Exacerbation = at least (>=)1 point increase in 2 functional systems/2 points increase in 1 system,either in pyramidal, cerebral, brain-stem, sensory, bowel and bladder, visual, cerebral or other functional system or >=0.5 point increase on expanded disability status scale (EDSS) which assesses disability in 8 functional systems with overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).|Baseline up to 96 weeks (+/- 1 week) or early termination (ET)|The Intention to Treat (ITT) population included all the participants who were randomized and received study medication.|||participants|||Number
1415514|NCT01134614|Secondary|Proportion of Patients With Objective Response|Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.|||Proportion of patients||95% Confidence Interval|Number
1415534|NCT01134549|Secondary|Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||hr*μg/L||Standard Deviation|Mean
1416289|NCT01128192|Primary|Change in High Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of high dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10||||percentage of EGP inhibition||Standard Deviation|Mean
1415515|NCT01134614|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.|||Months||95% Confidence Interval|Median
1415516|NCT01134614|Primary|Overall Survival|Overall survival is defined as the time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All randomized patients are included in this analysis.|||Months||95% Confidence Interval|Median
1415517|NCT01134562|Secondary|Percent AUC Extrapolated to Infinity (AUCINF) Resulting From Extrapolation From 65 Hours Onward for Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide and with available data.|||percentage of AUCINF||Standard Deviation|Mean
1415518|NCT01134562|Secondary|Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide and with available data; The half-life associated with the terminal (log-linear) elimination phase values for the 40 mg dose level were not calculated due to poor log linear regression of the log concentration versus time profile during the terminal phase (r2 values <0.7).|||hr*μg/L||Standard Deviation|Mean
1415519|NCT01134562|Secondary|Area Under the Concentration-time Curve From Time 0 to 65 Hours Post-dose for Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide with available data.|||hr*μg/L||Standard Deviation|Mean
1415520|NCT01134562|Secondary|Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide||Pre-dose and at 0.17, 0.5, 1, 4, 8, 18, 24, 32, and 48 hours after study drug administration and prior to discharge from the clinical research unit (~65 hours).|Participants who were randomized and received any amount of etelcalcetide.|||μg/L||Standard Deviation|Mean
1415521|NCT01134562|Secondary|Percent Change From Baseline in Calcium Phosphorus Product||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).|Participants who were randomized and received any amount of study medication with available data at each time point.|||percent change||Standard Deviation|Mean
1415522|NCT01134562|Secondary|Percent Change From Baseline in Serum Phosphorus||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).|Participants who were randomized and received any amount of study medication with available data at each time point.|||percent change||Standard Deviation|Mean
1415523|NCT01134562|Secondary|Percent Change From Baseline in Ionized Calcium||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, and day 4 (discharge).|Participants who were randomized and received any amount of study medication with available data at each time point|||percent change||Standard Deviation|Mean
1415524|NCT01134562|Secondary|Percent Change From Baseline in Serum Corrected Calcium||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29|Participants who were randomized and received any amount of study medication and with available data at each time point. Only participants in Cohorts 4 and 5 had serum corrected calcium assessed on days 8, 15 and 29.|||percent change||Standard Deviation|Mean
1415525|NCT01134562|Secondary|Percent Change From Baseline in Serum Parathyroid Hormone (PTH)||Baseline and 30 minutes, 1, 4, 8, 18, 24, 32, 42, 48, and 56 hours post-dose, day 4 (discharge) and for Cohorts 4 and 5 only, days 8, 15 and 29|Participants who were randomized and received any amount of study medication with available data at each time point. Only participants in Cohorts 4 and 5 had PTH assessed on days 8, 15 and 29.|||percent change||Standard Deviation|Mean
1415526|NCT01134562|Primary|Number of Participants With Adverse Events||For Cohorts 1 to 3, from administration of study drug up until 21 days after study drug administration; for Cohorts 4 and 5 from administration of study drug until 28 days after study drug administration.|All participants who were randomized and received any amount of study medication.|||participants|||Number
1415527|NCT01134549|Secondary|Number of Participants With Antibodies to Etelcalcetide|Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).|Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.|Participants who received etelcalcetide|||Participants|||Count of Participants
1415528|NCT01134549|Secondary|Volume of Distribution at Steady State for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||liters||Standard Deviation|Mean
1415529|NCT01134549|Secondary|Total Body Clearance (CL) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||L/hr||Standard Deviation|Mean
1415530|NCT01134549|Secondary|Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||hours||Standard Deviation|Mean
1415531|NCT01134549|Secondary|Terminal Elimination Rate Constant (λz) for Etelcalcetide||Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||1/hr||Standard Deviation|Mean
1415535|NCT01134549|Secondary|Maximum Observed Concentration (Cmax) for Etelcalcetide|Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.|Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration.|Participants who received etelcalcetide|||μg/L||Standard Deviation|Mean
1415536|NCT01134549|Secondary|Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D||Baseline and 12, 24, and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
1415537|NCT01134549|Secondary|Percent Change From Baseline in Serum Calcitonin||Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
1415538|NCT01134549|Secondary|Change From Baseline in Serum Phosphate||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point|||mmol/L||Standard Deviation|Mean
1415539|NCT01134549|Secondary|Change From Baseline in Serum Corrected Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point|||mmol/L||Standard Deviation|Mean
1415540|NCT01134549|Secondary|Change From Baseline in Serum Total Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population with available data at each time point|||mmol/L||Standard Deviation|Mean
1415541|NCT01134549|Secondary|Percent Change From Baseline in Plasma Ionized Calcium||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
1415542|NCT01134549|Secondary|Percent Change From Baseline in Serum Parathyroid Hormone||Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose|Modified intent-to-treat population|||percent change||Standard Deviation|Mean
1415543|NCT01134549|Primary|Number of Participants With Adverse Events||From the first dose of study drug through 7 days.|The modified intent-to-treat (MITT) population consisted of all participants who were randomized and received study medication.|||participants|||Number
1415544|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class II|"Donor Specific Antibodies [DSAs] Class I will be checked 1, 3, and 6 months post transplant to monitor allograft function.~DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Each DSA can have a score of 10 maximum. However, patients may have more than one DSA and points can add up to more than 10. this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant.~However, patients may have more than one DSA and points can add up to more than 10 this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant. Patients can have an infinite number of donor specific antibodies, this score can be higher than 10."|6 months|Mean Donor Specific Antibody (DSA) Class II levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.|||DSA relative intensity score||Standard Deviation|Mean
1415545|NCT01134510|Secondary|Donor Specific Antibodies [DSA] Class I|"Donor Specific Antibodies [DSAs] Class I will be checked 1, 3, and 6 months post transplant to monitor allograft function.~DSA will be measured using a relative intensity score (RIS) ranges from 0 points = No DSA; 2 points = <5000MFI (weak intensity); 5 points = 5000-10,000 MFI (moderate intensty); 10 points = >10,000MFI (strong intensity). Each DSA can have a score of 10 maximum. However, patients may have more than one DSA and points can add up to more than 10. this depends on how many DSAs [Class I and/or Class II] are present at the time of transplant and quarterly after transplant. Patients can have an infinite number of donor specific antibodies, this score can be higher than 10."|6 months|Mean Donor Specific Antibody Class I levels at 1, 3, and 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.|||DSA relative intensity score||Standard Deviation|Mean
1415546|NCT01134510|Secondary|Serum Creatinine|Serum creatinine will be checked 6 months post transplant to monitor allograft function.|6 months|Mean serum creatinine levels at 6 month post-transplant from 10 patients in the C1 Esterase Inhibitor group and 10 patients in the placebo group were calculated.|||mg/dl (serum cr at 6m post transplant)||Standard Deviation|Mean
1415547|NCT01134510|Primary|Post-transplant Biopsy to Identify Rejection Episodes|"Subjects will have a routine kidney biopsy 6 month after transplant to screen for episodes of acute rejection.~For purposes of this investigation, antibody-mediated rejection (AMR) is defined as follows:~Deterioration of allograft function in a high-risk transplant recipient (i.e. sensitized patient with history of Donor Specific Antibodies) measured by serum Creatinine and estimated Glomerular Filtration Rate~Association with the presence of Donor Specific Antibody (usually increasing in strength) measured by luminex techniques.~Biopsy evidence of capillaritis, inflammation and C4d deposition."|6 month|9 patients in each arm completed 6 month protocol biopsy. 1 patient in the placebo arm was withdrawn before 6M biopsy. 1 patient in treatment arm refused protocol biopsy.|||Episode of rejection|||Number
1415548|NCT01134393|Secondary|Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time||weeks 4 and 8|FAS|||Number of participants|||Number
1415549|NCT01134393|Secondary|DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements|DBP control: DBP <85 mmHg, SBP control: SBP <135 mmHg, DBP response: DBP <85 mmHg or a reduction from baseline >=10 mmHg, SBP response: SBP <135 mmHg or a reduction from baseline >= 15 mmHg|weeks 4, 8 and 12|FAS and LOCF and with at least one post baseline HBPM measurement|||Number of participants|||Number
1415550|NCT01134393|Secondary|Percentage of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|weeks 4, 8 and 12|FAS with non-missing data|||Percentage of participants|||Number
1415551|NCT01134393|Secondary|DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|weeks 4, 8 and 12|FAS and LOCF|||Number of participants|||Number
1415552|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure||weeks 4, 8 and 12|There was no information in the Case Report Form (CRF)||||||
1415553|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate|Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12.|weeks 4, 8 and 12|Treated Set (TS) with non-missing data|||bpm||Standard Deviation|Mean
1415554|NCT01134393|Secondary|Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP||weeks 4, 8 and 12|FAS with non-missing data|||mmHg||Standard Deviation|Mean
1415555|NCT01134393|Secondary|BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).|Achieving BP control with HBPM is defined as SBP<135 mmHg and DBP<85 mmHg.|Week 12|FAS and LOCF and with at least one post baseline HBPM measurement|||Number of participants|||Number
1415556|NCT01134393|Secondary|BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|4 and 8 weeks|FAS and LOCF|||Number of participants|||Number
1415557|NCT01134393|Primary|Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.|Achieving BP control is defined as SBP<140 mmHg and DBP<90 mmHg.|12 weeks|Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used.|||Percentage of participants||95% Confidence Interval|Number
1415558|NCT01134328|Secondary|Tolerability of Study Medication at Visit 3|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1415559|NCT01134328|Secondary|Tolerability of Study Medication at Visit 2B|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
1415560|NCT01134328|Secondary|Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415561|NCT01134328|Secondary|Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415562|NCT01134328|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415563|NCT01134328|Secondary|Lid Swelling at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415564|NCT01134328|Secondary|Lid Swelling Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415565|NCT01134328|Secondary|Lid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Lid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of lid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415566|NCT01134328|Secondary|Total Redness at 8 Hours Post-Dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415567|NCT01134328|Secondary|Total Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415568|NCT01134328|Secondary|Total Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Total redness was defined as the sum of the conjunctival, ciliary and episcleral redness scores, and was, thus, on a 0-12 scale, making the threshold for clinical significance a treatment difference of 3.0 units. Higher scores represent greater severity.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415569|NCT01134328|Secondary|Episcleral Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415570|NCT01134328|Secondary|Episcleral Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of Episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415571|NCT01134328|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415572|NCT01134328|Secondary|Ciliary Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415573|NCT01134328|Secondary|Ciliary Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415574|NCT01134328|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Per protocol population|||units on a scale||Standard Deviation|Mean
1415575|NCT01134328|Primary|Conjunctival Redness at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1415576|NCT01134328|Primary|Conjunctival Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1415577|NCT01134328|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1415578|NCT01134328|Primary|Ocular Itching at 8 Hours Post-dose at Visit 4A|A treatment efficacy CAC was performed 8 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1415579|NCT01134328|Primary|Ocular Itching at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT) Population with Last Observation Carried Forward (LOCF)|||units on a scale||Standard Deviation|Mean
1415580|NCT01134328|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1415581|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||g/dL||Standard Deviation|Mean
1415582|NCT01134315|Secondary|Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||pg/mL||Standard Deviation|Mean
1415583|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||pg/mL||Standard Deviation|Mean
1415584|NCT01134315|Secondary|Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]) with measurements at baseline and given time point.|||ng/mL||Standard Deviation|Mean
1423974|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 2 hours after breakfast|2 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1415585|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.|||mg/dL||Standard Deviation|Mean
1415586|NCT01134315|Secondary|Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)|Normal ranges for these chemistry measurements varied according to the age of the participant.|Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]); n=number of participants with measurements at baseline and given time point.|||mEq/L||Standard Deviation|Mean
1415587|NCT01134315|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All participants|||participants|||Number
1415588|NCT01134315|Primary|Percentage of Participants With at Least One Incidence of Hypercalcemia|Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.|Monitored from time of informed consent through end of study + 30 days (total of 745 days).|All Treated Population (all participants who received at least 1 dose of paricalcitol [paricalcitol group] or at least one dose of calcitriol [calcitriol group]).|||percentage of participants|||Number
1415589|NCT01134276|Secondary|Total Hospital Cost During Admission After Biliary Drainage|Total hospital cost during admission after Biliary Drainage in US dollars|during hospital stay for biliary drainage procedure||||thousands in US dollars||Standard Deviation|Mean
1415590|NCT01134276|Secondary|Change in Total Serum Bilirubin After Drainage|Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)|within 14 days after drainage||||mg/dL/day||Standard Deviation|Mean
1415591|NCT01134276|Primary|Incidence of Infectious Complications After Biliary Drainage|at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)|within 120 days after drainage||||participants|||Number
1415592|NCT01134198|Primary|Number of Participants With Relapse by Days 10 and 28|assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed.|assessed during 8 weeks of trial, but reported for days 10 and 28 of trial|participants entering phase 2 of trial|||Participants|||Count of Participants
1415593|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1415594|NCT01134107|Other Pre-specified|Change From Baseline to 12 Week Endpoint for Each Treatment in Weight||Baseline, endpoint for each 12-week treatment period|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.|||kilograms (kg)||Standard Deviation|Mean
1415595|NCT01134107|Other Pre-specified|Hypoglycemic Episode Rate Per 30 Days|"All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||hypoglycemic episodes per 30 days||Standard Deviation|Mean
1415596|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hypoglycemic Episode|"A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L).~All Reported Hypoglycemic Episodes are defined as an event which is associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)"|All days for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||percentage of participants|||Number
1415609|NCT01134055|Secondary|Plasma Concentrations of Pazopanib|All participants in the eye drop containing arms had a single blood sample drawn for assessment of pazopanib plasma concentration at the Week 4, Week 24 and Week 24. The sample was drawn without restriction for the time interval between blood draw and the last dose of IP eye drops.|Week 4, Week 24 and Week 52|Safety Population. Only participants with data available at the indicated time points were analyzed.|||nanogram/milliliter||95% Confidence Interval|Mean
1415680|NCT01133665|Secondary|Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415597|NCT01134107|Other Pre-specified|Pump Complications Rate Per 30 Days|Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||pump complications per 30 days||Standard Deviation|Mean
1415598|NCT01134107|Other Pre-specified|Percentage of Participants With Pump Complications|Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, reservoir change (infusion set change reason only), and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||percentage of participants|||Number
1415599|NCT01134107|Other Pre-specified|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||hyperglycemic episodes per 30 days||Standard Deviation|Mean
1415600|NCT01134107|Other Pre-specified|Percentage of Participants Having a Hyperglycemic Episode|A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating|Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||percentage of participants|||Number
1415601|NCT01134107|Other Pre-specified|Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.|||Units (U) of insulin||Standard Deviation|Mean
1415602|NCT01134107|Secondary|Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%||Endpoint for each 12-week treatment period|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.|||participants|||Number
1415603|NCT01134107|Secondary|Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values||Baseline, endpoint for each 12-week treatment period|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.|||percentage of HbA1c||Standard Deviation|Mean
1415604|NCT01134107|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||Days 1-6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.|||Units (U) of insulin||Standard Deviation|Mean
1415605|NCT01134107|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D.|Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on a Day 6, or Day 2 depending on the analysis, for the respective treatment arm: insulin lispro 6D and insulin aspart 6D.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1415606|NCT01134107|Primary|Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use||Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)|All randomized participants who completed at least one post-randomization visit. Those included in the primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1415607|NCT01134081|Primary|Differences in Angiogenic Biomarkers: PDGF-BB|Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas|5 time-points: pre-surgical, week(s) 1, 2, 3 and 4|44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.|||pg/mL||Standard Error|Mean
1415608|NCT01134081|Primary|Differences in Angiogenic Biomarkers|Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas|5 time-points: pre-surgical, week(s) 1, 2, 3 and 4|44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.|||ng/mL|Surgical sites|Standard Error|Mean
1415610|NCT01134055|Secondary|Number of Participants With Laboratory Data of Clinical Concern for Urine Protein|Urine Samples were collected from Day 1 to Week 28 and Week 52 for analyses. In this dipstick test, the level of protein in urine samples was recorded as negative (Neg), trace (tr), 1+, 2+, and 3+ (the plus sign increases with a higher level of proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Neg indicated no proteinuria and 3+(high positive) indicated worst proteinuria.|Day 1 to Week 28 and Week 52|Safety Population|||Participants|||Count of Participants
1415611|NCT01134055|Secondary|Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern|The Laboratory Parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Bicarbonate, Creatinine, Glucose, Hemoglobin, Lymphocytes, Platelet count, Potassium, Sodium, Thyroid Stimulating Hormone (TSH), Total Bilirubin, Total Neutrophils, Blood Urea Nitrogen (BUN) and White Blood Cell count (WBC). Number of participants with Laboratory outside of clinical concern Range were summarized here. Data of high and low from the clinical concern range has been provided here. Here 'High' denotes above normal range and 'Low' denotes below normal range for all the categories.|Up to Week 52|Safety Population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1415612|NCT01134055|Secondary|Summary of Abnormal Electrocardiogram (ECG) Findings|12-Lead ECGs were performed in triplicate and were obtained on Weeks 4 to Week 28 and Week 52. The on-treatment ECGs were used to ascertain any risk of QTc interval prolongation at extremely low pazopanib exposures compared to what was routinely observed in participants with cancer. The on-treatment ECG data collected from participants assigned to one of the control arms also provided ECG background rate data for participants not exposed to pazopanib. Participants with Clinically significant abnormal ECGs are included here.|Week 4, Week 28, Week 44 and Week 52|Safety population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1415613|NCT01134055|Secondary|Number of Participants With Vital Sign Values Outside of Clinical Concern Range|Vital signs including systolic and diastolic blood pressure and heart rate were measured throughout the study. Number of participants with vital signs outside of clinical concern Range were summarized. 'High' denotes above normal range and 'Low' denotes below normal range for all the categories. The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to Week 52|Safety Population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1415614|NCT01134055|Secondary|Summary of Intraocular Pressure Exam Findings|Intraocular pressure (IOP) measurement was done with Goldmann tonometer. Intraocular pressure was measured prior to dilating the pupil and, to account for diurnal variation, at approximately the same time of day for every visit.|Up to week 52|Safety Population|||Participants|||Count of Participants
1415615|NCT01134055|Secondary|Summary of Potentially Clinically Important Findings for Ophthalmic Examinations|Opthalmicexaminations were done on Ocular alignment and motility, pupillary function, and visual fields by confrontation. Slit-lamp biomicroscopic examination of the anterior segment structure was performed. Fundus slit-lamp biomicroscopic examination, including use of accessory diagnostic lenses, to view the vitreous, retina (including posterior pole and periphery), macula, vasculature, and optic nerve was also performed. These examinations were performed on the study eye (SE) and the Fellow eye (FE). Participants with abnormal findings are listed here.|Up to Week 52|Safety population|||Participants|||Count of Participants
1415616|NCT01134055|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|Up to 52 Weeks|Safety Population|||Participants|||Count of Participants
1415617|NCT01134055|Secondary|Change in Area of Serous Sensory Retinal Detachment (SSRD)|This is an Optical coherence tomography (OCT) parameter used to manually measure thickness along any scan. OCT was performed at week 28 and week 52.|Day 1, Week 28 and Week 52|Intent to Treat Population|||mm^2||Standard Error|Least Squares Mean
1415618|NCT01134055|Secondary|Change From Baseline in the Area of Fluorescein Leakage|Fluorescein angiograms was performed at the Screening, Week 12, Week 28, and Week 52 Visits. All images, including any that were performed at the investigator’s medical discretion, were transferred to the FPRC. Fluorescein was injected intravenously according to usual clinic procedures. Dose response was also examined under different aspects of re-injection, such as time to first injection, the percentage of participants that required an injection by Week 28, as well as the estimation of the probability of reinjection. FA assessments of area of fluorescein leakage, CNV area and area of CNV lesion complex were also examined for dose differentiation.|Day 1, Week 28 and Week 52|Intent to Treat Population|||mm^2||Standard Error|Least Squares Mean
1415619|NCT01134055|Secondary|Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis)|CNV is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.|Day 1, Week 28 and Week 52|Intent to Treat Population|||mm^2||Standard Error|Least Squares Mean
1415620|NCT01134055|Secondary|Change From Baseline in the Area of Choroidal Neovascularisation (CNV)|Choroidal neovascularisation is progressive worsening of vision that can cause hemorrhage and exudation, and finally disciform scarring and retinal atrophy. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.|Day 1, Week 28 and Week 52|Intent to Treat Population|||Millimeter (mm)^2||Standard Error|Least Squares Mean
1415621|NCT01134055|Secondary|Number of Participants That Met Criteria for Re-injection|The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection.|Up to Week 52|Intent to Treat Population|||Participants|||Count of Participants
1415622|NCT01134055|Secondary|Change From Baseline in Center Point Thickness (CPT) Over Time|CPT was the inner limiting membrane to the beginning of the retinal pigment epithelium (RPE) inclusive of SR fluid. The outer boundary included the outer segment of the photoreceptors and not included the RPE. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study. In amendment 3, inclusion criterion number 5 was revised to remove the required quantitative OCT component. OCT examination was used to supplement FA findings and provided qualitative (presence of SR and/or IR fluid) and quantitative (a CPT that is at least 250 microns) evidence of an active subfoveal lesion. Hence data for pre and post amendment have been provided separately.|Baseline and Week 52|Intent to Treat Population|||Microns||Standard Deviation|Mean
1415623|NCT01134055|Secondary|Number of Participants Analyzed for Visual Acuity (VA) Response Over Time|VA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters.The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. This outcome measure contains the number of participants who were analyzed for VA response.|Week 52|Intent to Treat Population|||Participants|||Count of Participants
1415624|NCT01134055|Secondary|Number of Participants With BCVA Over Time|BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters.|Up to Week 52|Intent to Treat Population. Only participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1415625|NCT01134055|Secondary|Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks|The investigator interpreted each Week 4 to Week 52 Optical coherence tomography (OCT) scan, BCVA score, and available Fluorescein angiography (FA)/Fundus photography (FP) and re-injected if one or more criteria were met. The criteria were: Evidence of Intraretinal (IR) (with or without cysts) fluid or Subretinal (SR) fluid, a serous retinal pigment epithelial detachment, a notable decline in Visual Acuity, new SR or IR macular hemorrhage that the investigator judges is associated with Choroidal neovascularization, increased lesion size on FA relative to the last angiogram as judged by the investigator or leakage on FA that the investigator judges would benefit from re-injection. Injection rate over 52 weeks was computed by taking the number of injections received divided by the number of visits for the participant. Likewise for 28 weeks it was estimated as the number of post baseline injections received divided by the number of post baseline visits at or before the week 28 visit.|Up to 52 weeks|Intent to Treat Population|||Percentage of re-injections||Standard Error|Least Squares Mean
1415626|NCT01134055|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52|BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.|Day 1 and 52 weeks|Intent to Treat Population - It consisted of all randomized participants, according to the treatment groups assigned by randomization (i.e., planned rather than the actual treatment regimen), who received at least one dose of study medication. Only participants with data available at the indicated time points were analyzed.|||Letters||Standard Error|Least Squares Mean
1415627|NCT01134042|Other Pre-specified|Number of the Indicated Unscheduled Asthma-related Healthcare Visits During the Treatment Period|All unscheduled asthma-related visits to a physician’s office, visits to urgent care, visits to the emergency department, and hospitalizations (ICU=intensive care unit; GW=general ward) associated with severe asthma exacerbations or other asthma-related healthcare issues were recorded.|From Baseline up to Week 24/Withdrawal Visit|ITT Population|||Number of visits||Standard Deviation|Mean
1415628|NCT01134042|Other Pre-specified|Number of Participants With the Indicated Global Assessment of Change Questionnaire Responses at Weeks 4, 12, and 24|At the end of Week 4, Week 8, and Week 24/Early Withdrawal, the Global Assessment of Change Questionnaire that assesses changes in asthma symptoms (AS) and rescue medication use (RMU) was completed by the participants. The number of participants who chose the following answers to the questionnaire were determined: much better, somewhat better, a little better, the same, a little worse, somewhat worse, much worse (to assess the changes in asthma symptoms); much less often, somewhat less often, a little less often, the same, a little more often, somewhat more often, much more often (to assess the changes in the frequency of rescue medication use).|Week 4, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
1416290|NCT01128192|Primary|Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition|Change from Day 3 and Day 10 of low dose % EGP Inhibition (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10||||percentage of EGP Inhibition||Standard Deviation|Mean
1415629|NCT01134042|Other Pre-specified|Change From Baseline in the Asthma Control Test (ACT) Scores at Week 12 and Week 24|"The ACT is a 5-item questionnaire developed as a measure of the participant's asthma control. Questions are designed to be self-completed by the participant and include the following: In the past 4 weeks, How much of the time did your asthma keep you from getting as much done at work, school or at home?, How often have you had shortness of breath?, How often did your asthma symptoms wake you up at night or earlier than usual in the morning?, How often have you used your rescue inhaler or nebulizer medication (such as albuterol)? and How would you rate your asthma control? The ACT total score is defined as the sum of the scores from all 5 questions, provided all questions have been answered; thus, the total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma). A score of 20 or higher indicates well-controlled asthma. Change from Baseline was calculated as the total score at Week 12 and Week 24/Early Withdrawal minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
1415630|NCT01134042|Other Pre-specified|The Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.|From the first dose of the study medication up to Week 24/Early Withdrawal|ITT Population|||participants|||Number
1415631|NCT01134042|Other Pre-specified|Mean Change From Baseline in Daily Morning Trough (AM) and Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Trough PEF is the PEF measured approximately 24 hours after the last administration of study drug. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough AM/PM PEF over 12 weeks and 24 weeks of the 24-week Treatment Period (at Weeks 12 and 24) minus the Baseline value.|From Baseline up to Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
1415632|NCT01134042|Other Pre-specified|Change From Baseline in Weighted Mean Serial FEV1 Over 0 to 4 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at Baseline. Weighted mean was calculated using the 4-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, and 4 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.|||Liters||Standard Deviation|Mean
1415633|NCT01134042|Other Pre-specified|Clinic Visit 12-hour Post-dose FEV1at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. 12-hour post-dose FEV1 measurements were taken electronically by spirometry at the Week 24 clinic visit. The highest of 3 technically acceptable measurements was recorded.|Week 24|ITT Population. 12-hour post-dose FEV1 was analyzed in the subset of participants for whom serial FEV1 at Week 24 was performed.|||Liters||Standard Deviation|Mean
1415634|NCT01134042|Secondary|Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24/Early Withdrawal|"The AQLQ is a disease-specific, self-administered quality of life questionnaire used to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ for 12 years and older (AQLQ [+12]) is a modified version of the AQLQ for use in asthma patients between the age of 12 and 70. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). For the 32 items on the questionnaire, the response format consists of a seven-point scale, where a value of 1 indicates “total impairment” and a value of 7 indicates “no impairment.” The AQLQ total score is defined as the average of the scores from all 32 questions; thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment). Baseline was the total score obtained at Visit 3. Change from Baseline was calculated as the total score at Weeks 12 and 24 minus the total score at Baseline."|Baseline, Week 12, and Week 24/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
1415635|NCT01134042|Secondary|Change From Baseline in the Percentage of Rescue-free and Symptom-free 24-hour Periods at the End of the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). Similarly, asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant’s responses to both the morning and evening assessments indicated no use of rescue medication/symptoms was considered to be rescue free/symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of periods||Standard Error|Least Squares Mean
1415798|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 52 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415636|NCT01134042|Primary|Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Baseline and Week 24 clinic visits. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the pre-dose assessment (within 5 minutes prior to dosing) and the post-dose assessments after 5, 15, and 30 minutes and 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline was the value obtained at Visit 3. Change from Baseline was calculated as the average Week 24 FEV1 value minus the Baseline value.|Baseline and Week 24|ITT Population. Weighted mean serial FEV1 was calculated in the subset of participants for whom serial FEV1 at Week 24 was performed.|||Liters||Standard Error|Least Squares Mean
1415637|NCT01134042|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit while still on treatment. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline (BL) through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. BL was the pre-dose value obtained at Visit 3. Change from BL was calculated as the Week 24 value minus the Baseline value. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of BL trough FEV1, country, sex, age, and treatment group.The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-BL on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of the study medication. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
1415638|NCT01134016|Secondary|Safety Blood and Urine Test|"Hematology laboratory data~Biochemistry laboratory data~Urinalysis~AE; AE not including the natural progress of the underlying disease~Incidence of toxicity ≥ grade 3 according to NCI CTCAE version 4.03~Physical examination~Vital signs changes~Electrocardiogram examination results (including HR, QRS, QT, QTc, RR intervals)"|pre-screenting and every 14-day period|||||||
1415639|NCT01134016|Secondary|Number of Participants in the PP Population With Better Than SD at Target Lesion, Better Than Non-CR/Non-PD at Non-target Lesion and no New Lesion|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for overall response by CT: Judgement by total siutation of target, non-target and new lesions.~Meaning of Target lesion: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), Sum down 30% or more from target lesion baseline; Progressive Disease(PD), Sum up at least 20% from smallest value (nadir) and Absolute increase ≥ 5 mm; Stable Disease (SD), Neither enough shrinkage for PR nor enough growth for PD.~non-target lesion: CR: All non-target lesions disappeared and All lymph nodes <10 mm; Non-CR/Non-PD: Non-target lesion(s) still present and Lymph nodes ≥10 mm; PD: Unequivocal progression; New lesion :Unequivocal new cancer lesions Overall SD response should be better than SD at target lesion, better than Non-CR/Non-PD t non-target lesion and no new lesion."|pre-screening and end of treatment|Per-protocol (PP) Population: All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST).|||participants|||Number
1415640|NCT01134016|Secondary|AUC0-t on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28||||log(mg*hr/mL)||95% Confidence Interval|Mean
1415641|NCT01134016|Secondary|AUC0-t on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|within 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1||||log(mg*hr/mL)||95% Confidence Interval|Mean
1415642|NCT01134016|Secondary|Maximum Plasma Concentration After Dosing on Day 28|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28||||log(mg/ml)||95% Confidence Interval|Mean
1415643|NCT01134016|Secondary|Maximum Plasma Concentration After on Day 1|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1|Pharmacokinetic (PK) Population: All patients who received at least 1 dose of antroquinonol with sufficient post-dose bio-samples collected for PK profile characterization.|||Log(mg/ml)||95% Confidence Interval|Mean
1415644|NCT01134016|Secondary|Half-life Time From Overall Study|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28||||hours||Standard Deviation|Mean
1415645|NCT01134016|Secondary|Tmax After Dose|Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.|30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28||||hours||Full Range|Median
1415681|NCT01133665|Secondary|Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415646|NCT01134016|Primary|To Determind the Maximum Tolerable Dose for Antroquinonol|"The study design consisted of 2 phases, the accelerated titration phase and the standard titration phase.~During the accelerated titration phase, patients were enrolled in a cohort of 1 new patient for each dose level and treated for 4 weeks at that level. Any DLT or instance of MT during any 4 week treatment at any dose level led to the initiation of standard titration (3+3) phase.~If none of the first 3 patients experienced any DLT, then dose escalation proceeded for the next cohort of patients. If 1 of 3 patients developed DLT, the cohort was expanded to at most 6 patients (another 3 patients added subsequently). If exactly 1 of the 6 patients experienced DLT, then escalation to the next dose level occurred. If more than 1 patient developed DLT in any dose cohort, the dose escalation was withheld and the prior dose level was considered as the MTD unless the present dose level was level 1"|DLT is to be observed during 4 week period|Intent-to-Treat (ITT) Population: All patients who received at least 1 dose of antroquinonol.|||mg|||Number
1415647|NCT01133977|Other Pre-specified|Overall Response Rate (ORR) (for Phase 2)|ORR, defined as percentage of participants with best confirmed response (complete response [CR] or partial response [PR]). A confirmatory scan was required after no less than 4 weeks and no later than 8 weeks, starting on the date that the response was first recorded.|From the date of randomization until disease progression or death or up to approximately 2 years|||||||
1415648|NCT01133977|Other Pre-specified|Overall Survival (OS) (for Phase 2)|OS, defined as the time from the date of randomization until the date of death. Few events of deaths (9 events in the Lenvatinib + Dacarbazine arm and 4 events in the Dacarbazine arm) were reported to calculate the median OS or to draw conclusions regarding the OS.|From the date of randomization until death or up to approximately 2 years|||||||
1415649|NCT01133977|Other Pre-specified|Time to Progression (TTP) (for Phase 2)|TTP, defined as the time from the date of randomization until the date of progressive disease.|From the date of randomization until disease progression or death or up to approximately 2 years|||||||
1415650|NCT01133977|Secondary|Progression Free Survival (PFS) (for Phase 2)|PFS was defined as the time from the date of randomization of a participant until (1) the date of first documented progression of such participant's disease based on Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST v. 1.1) or (2) the date of such participant's death due to any cause. Progression was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions, based on Investigator assessment according to RECIST 1.1. If missing assessments, imputed dates were used in the analysis.|From the date of randomization until the date of disease progression or death (whichever was earlier) or up to approximately 2 years|All randomized participants who received at least one dose of study drug without major protocol eligibility violations were included in the Modified Intent-to-Treat (MITT) Analysis Set.|||Weeks||95% Confidence Interval|Median
1415651|NCT01133977|Primary|Number of Participants With Adverse Events/Serious Adverse Events (AEs/SAEs)|Safety assessments consisted of monitoring and recording all AEs, including all Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0) grades, and SAEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Details of AEs and SAEs are provided in the reported adverse event section.|From signing of informed consent up to 30 days after the last dose, up to approximately 2 years|Safety Analysis Set: All participants enrolled in the Phase 1b and Phase 2 portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.|||Participants|||Number
1415652|NCT01133977|Primary|Dose Limiting Toxicity (DLT) of Lenvatinib Administered in Combination With Dacarbazine (for Phase 1b)|DLTs were defined as clinically significant adverse events (AEs) occurring less than or equal to 21 days after commencing study treatment and considered by the Investigator to be possibly or probably related to study treatment.|From Day 1 through 21 days (one cycle)|Safety Analysis Set: All participants enrolled in the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.|||Participants with DLT|||Number
1415653|NCT01133860|Secondary|in Vitro Function of Platelets Produced During Therapy in Responding Patients|in vitro platelet function will be assessed in patients achieving a platelet count of 100 x10e9/L or more at the end of the therapy|21 days or 42 days of therapy||||participants|||Number
1415654|NCT01133860|Secondary|All Types of Adverse Events|All type of adverse events were registered.Results indicate the number of participants who experience a side effect of the drug.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy||||number of participants|||Number
1415655|NCT01133860|Secondary|Bleeding Tendency Assessed by WHO Bleeding Score|The percentage of patients with bleeding diathesis (grade 1, i.e. cutaneous bleeding, or grade 2, i.e. mild blood loss, according to WHO bleeding score) was calculated at baseline and at the end of therapy. The results are expressed as the mean change in the percentage of patients with bleeding diathesis (95%CI).|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy||||participants||95% Confidence Interval|Mean
1415656|NCT01133860|Primary|Response to Drug Based on Platelet Count at the End of Therapy|The primary endpoints were the achievement of a platelet count over 100 x10e9/L or at least 3 times the baseline value (major response), or at least twice the baseline value but less than major response (minor response). The overall response to therapy is reported. Platelet count was measured at the end of therapy (21 or 42 days, see study design) by phase-contrast microscopy.|21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy||||percentage of participants||95% Confidence Interval|Number
1415665|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Inattention|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
1415657|NCT01133847|Secondary|Test of Silent Reading Fluency and Comprehension (TOSREC)|The TOSREC measures sentence-level comprehension and silent reading fluency. It is a sentence verification task; children are presented with a list of sentences and must tell whether they are true or false. Items are based on common knowledge (e.g., All apples are blue). The raw score is the number of items answered correctly in 3 minutes. Standardized with a mean of 100 and standard deviation of 15 are reported here. Higher scores represent a better outcome.|Week 16, End of Active Treatment Phase|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
1415658|NCT01133847|Secondary|Test of Word Reading Efficiency (TOWRE) - Phonemic Decoding Efficiency|The TOWRE Phonemic Decoding Efficiency measures the student’s fluent decoding of nonsense words that follow the spelling rules of the English language. The raw score is the number of nonwords identified correctly in 45 seconds. Standardized scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
1415659|NCT01133847|Secondary|Test of Word Reading Efficiency (TOWRE) - Sight Word Efficiency|The TOWRE Sight Word Efficiency subtest measures fluency of reading words in lists. The raw score is the number of words or nonwords identified correctly in 45 seconds. Standard scores with a mean of 100 and standard deviaion of 15 are reported here. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
1415660|NCT01133847|Secondary|Dynamic Indicators of Basic Early Literacy Skills Oral Reading Fluency Subtest (DIBELS ORF)|DIBELS ORF measures oral reading fluency in connected text. Students are presented with a passage on their grade level to read orally, and the score is the number of words of the passage read correctly in a one-minute period. Students in this study read two passages at each test administration, and the mean score for the two passages was the dependent variable analyzed. A research synthesis of studies reporting psychometric properties for DIBELS ORF determined that reliability coefficients in these studies exceeded .80 and that the measure demonstrated moderate to high concurrent and predictive validity across studies (Goffreda & DiPerna, 2010).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||words read correctly per minute||Standard Deviation|Mean
1415661|NCT01133847|Secondary|Wechsler Individual Achievement Test-III (WIAT-III) Reading Comprehension Subtest|The WIAT-III is an individually-administered test of academic achievement. This subtest involves reading sentences and longer passages and then answering a set of literal and inferential comprehension questions about the text. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.|Week 16, End of Active Treatment Phase|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error.|||standardized scores||Standard Error|Least Squares Mean
1415662|NCT01133847|Primary|Wechsler Individual Achievement Test-III (WIAT-III) Pseudoword Decoding Subtest|The WIAT-III is an individually-administered test of academic achievement. In the Pseudoword Decoding subtest students read a list of increasingly difficult nonsense words as a test of their ability to use phonics to decode unknown words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15. Higher scores represent a better outcome.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||standardized scores||Standard Error|Least Squares Mean
1415663|NCT01133847|Primary|Wechsler Individual Achievement Test-III (WIAT-III) Word Reading Subtest|The WIAT-III is an individually-administered test of academic achievement. In the Word Reading subtest students read a list of increasingly difficult words. Scores reported here are standardized scores with a mean of 100 and standard deviation of 15.|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other discrepancies in numbers are due to missing data.|||standardized scores, M=100, SD = 15||Standard Error|Least Squares Mean
1415664|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Teacher Rating of Hyperactivity-impulsivity|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|Week 16 (End of Active Treatment Phase) and Follow-Up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
1415679|NCT01133665|Secondary|Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1423975|NCT01064739|Secondary|Plasma Norepinephrine|Plasma norepinephrine 1 hour after breakfast|1 hour after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1415666|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Hyperactivity-impulsivity|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|16 weeks (end of Active Treatment phase), and follow-up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1415667|NCT01133847|Primary|Swanson, Nolan, and Pelham Checklist for DSM-IV (SNAP)- Parent Rating of Inattention|Rating Scale of ADHD symptomology completed by parents and teachers. Raters evaluate how well each DSM-IV (Diagnostic and Statistical Manual) ADHD symptom describes a child on a four-point Likert scale (0=Not at all, 1=Just a little, 2=Quite a bit, 3=Very much). The measure shows adequate internal consistency (.94) and test-retest reliability (Bussing et al., 2008; Gau et al., 2008).|16 weeks (end of Active Treatment phase), and follow-up|Six excluded from analyses (1 from ADHD Treatment , 1 from Intensive Reading Instruction , 4 from Combined ) because upon ex post-facto review of records, they did not meet inclusion criteria and had been included in error. Other reductions in numbers analyzed on this variable were due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
1415668|NCT01133821|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form|Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ-SF; Total Scores) describes difference in Quality of Life Scores from Baseline to Week 20; The QLESQ-SF is a self-report measure of life satisfaction, with 16 items rated from 1 (very poor) to 5 (very good) to produce a score from 0 to 80 with higher scores indicating better quality of life. In this report, we record change in scores from baseline to follow up|20 weeks|Analyzed data from participants for whom values were available both at baseline and at twenty weeks|||units on a scale||Standard Deviation|Mean
1415669|NCT01133821|Primary|Remission|Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8)|20 weeks|Intent to treat; patients were assessed weekly|||Participants|||Count of Participants
1415670|NCT01133756|Secondary|Biomarker-based Proportion of Biomarker-Progression-Free Survival (B-PFS) at Week 12, Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Week 12|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.||||||
1415671|NCT01133756|Secondary|Biomarker CA125-based Overall Response Rate (B-ORR), Within Treatment Group|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.|Day 1 of every cycle, at end of treatment visit and every 2 months during follow-up period for patients who complete study without progressive disease.|Due to the limited enrollment despite significant diligence to boost enrollment and the complex study design required to manage hematologic toxicity, the study was terminated before the initiation of Phase 2. Hence the analysis was not conducted.||||||
1415672|NCT01133756|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLTs were defined as clinically significant adverse events occurring less than or equal to 21 days after commencing study treatment and considered to be possibly or probably related to study treatment by the Investigator. If 1 DLT occurred at any dose level, the cohort was to be expanded to include a maximum of six evaluable subjects. If 2 DLTs occurred at any dose level, the maximum tolerated dose (MTD) was to be either defined as the preceding dose, or an intermediate dose. To evaluate an intermediate dose, an additional dose cohort could be added to more accurately define the MTD.|Cycle 1 (21 days)|Safety analysis was evaluated based on Safety Population, defined as all subjects enrolled into the Phase 1b portion of this study, except for those who (i) dropped out of the study prior to receiving any study drug, or (ii) were without any safety assessments following the first dose of study drug.|||Participants|||Number
1415673|NCT01133704|Secondary|Overall Survival|Subjects were followed for 3 years from the time of randomization or until death.|Time from randomization until 36 months|All randomized participants|||Months||95% Confidence Interval|Median
1415674|NCT01133704|Primary|Overall Time to Disease Progression|Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.|from randomization to 36 months||||Weeks||95% Confidence Interval|Median
1415675|NCT01133665|Secondary|Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415676|NCT01133665|Secondary|Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415677|NCT01133665|Secondary|Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415678|NCT01133665|Secondary|Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415754|NCT01132846|Secondary|Development of Cardio-renal Syndrome||Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||participants|||Number
1415682|NCT01133665|Secondary|Number of Participants With Back Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415683|NCT01133665|Secondary|Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415684|NCT01133665|Secondary|Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415685|NCT01133665|Secondary|Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415686|NCT01133665|Secondary|Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415687|NCT01133665|Secondary|Number of Participants With Fever Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415688|NCT01133665|Secondary|Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 3|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415689|NCT01133665|Secondary|Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415690|NCT01133665|Secondary|Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415691|NCT01133665|Secondary|Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415692|NCT01133665|Secondary|Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415693|NCT01133665|Secondary|Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415694|NCT01133665|Secondary|Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415695|NCT01133665|Secondary|Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415696|NCT01133665|Secondary|Number of Participants With Headache Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415697|NCT01133665|Secondary|Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415698|NCT01133665|Secondary|Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415699|NCT01133665|Secondary|Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415700|NCT01133665|Secondary|Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415701|NCT01133665|Secondary|Number of Participants With Vomiting Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415702|NCT01133665|Secondary|Number of Participants With Pain Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 month|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415703|NCT01133665|Secondary|Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415704|NCT01133665|Secondary|Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415705|NCT01133665|Secondary|Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415706|NCT01133665|Secondary|Number of Participants With Nausea Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415707|NCT01133665|Secondary|Number of Participants With Anorexia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415708|NCT01133665|Secondary|Number of Participants With Anemia Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415709|NCT01133665|Secondary|Number of Participants With Constipation Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415710|NCT01133665|Secondary|Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415711|NCT01133665|Secondary|Number of Participants With Fatigue Related to Cetuximab/Lenalidomide|Toxicity was scored according to NCI/CTC version 4|24 months|The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide|||participants|||Number
1415712|NCT01133665|Primary|Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.|Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|24 months||||months||Full Range|Median
1415713|NCT01133626|Primary|The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment|"Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome."|Day 0 (Baseline), Day 42|Per protocol population|||ratio||Standard Error|Geometric Mean
1415714|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in PCSK9|Serum PCSK9 concentrations were determined by using a qualified enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 15 ng/mL.|Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data|||percent change||Standard Deviation|Mean
1415715|NCT01133522|Secondary|Percent Change From Baseline to End of the Dosing Interval in LDL-C||Baseline and Day 43 for QW and Q2W groups or Day 57 for Q4W group|Participants with non-missing data|||percent change||Standard Deviation|Mean
1415716|NCT01133522|Secondary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Evolocumab|Area under the unbound evolocumab serum concentration-time curve from time of last dose to time of last quantifiable concentration following the last dose of evolocumab.|Day 29 predose (last dose for Cohorts 3-7) and Days 36 (predose for Cohorts 1 and 2), 40, 43, 50, 57, 64, 71, 78, and 85|Pharmacokinetic analysis set with available data|||day*μg/mL||Standard Deviation|Mean
1415717|NCT01133522|Primary|Number of Participants With Anti-Evolocumab Antibodies|Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-evolocumab binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-evolocumab neutralizing antibodies|From the first dose of study drug until Day 85|Safety analysis set|||participants|||Number
1415718|NCT01133522|Secondary|Maximum Observed Plasma Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 800 ng/mL.|Day 1, predose and Days 4, 8, 15, 22, 29, 36, 40, 43, 50, 57, 64, 71, 78, and 85|The Pharmacokinetic analysis set consisted of all participants for whom at least 1 pharmacokinetic parameter or endpoint could be adequately estimated. Serum evolocumab concentrations were not detectable in Cohorts 1 and 2.|||μg/mL||Standard Deviation|Mean
1415755|NCT01132846|Secondary|Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio|"BUN measured in mg/dL Cystatin C measured in mg/L~No units were used in calculated the ratio"|Randomization to 72 hours||||ratio||Standard Deviation|Mean
1415756|NCT01132846|Secondary|Cumulative Urinary Sodium Excretion||Randomization to 72 hours||||mmol||Standard Deviation|Mean
1415719|NCT01133522|Primary|Number of Participants With Adverse Events|"The relationship of each adverse event to the investigational product was assessed by the investigator.~A serious adverse event (SAE) is defined as an adverse event that~is fatal~is life threatening (places the subject at immediate risk of death)~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~other significant medical hazard."|From the first dose of study drug until Day 85|Safety analysis set|||participants|||Number
1415720|NCT01133418|Secondary|Academic Improvement Measurement System - Web-based (AIMSWEB) Reading Score (Proportion Accurate)|Number of words read correctly divided by number of words read (range = 0-1.0) Higher values represent better reading accuracy|2 months||||units on a scale||Standard Deviation|Mean
1415721|NCT01133418|Secondary|Intra-individual Variability on Go/No-Go Task|Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task|2 months||||milliseconds||Standard Deviation|Mean
1415722|NCT01133418|Primary|Clinical Global Impression - Improvement|Blinded ratings of clinical global impression - Improvement. Scale = 1 (Very Much Improved) - 7 (Very Much Worse) Lower scores represent more improvement.|2 months|One child in the Cognitive Training Group and one child in the Non-progressive Cognitive Training group were missing CGI data.|||units on a scale||Standard Deviation|Mean
1415723|NCT01133418|Primary|Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale|"Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0=Never; 1=Occasionally; 2=Often; 3=Very often); higher scores indicate higher severity of ADHD symptoms."|2 months||||units on a scale||Standard Deviation|Mean
1415724|NCT01133392|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.|||grams (g)||Geometric Coefficient of Variation|Geometric Mean
1415725|NCT01133392|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)|Time of maximal glucose infusion rate.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PD data.|||hours||Geometric Coefficient of Variation|Geometric Mean
1415726|NCT01133392|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacodynamic (PD) data.|||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
1415727|NCT01133392|Secondary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]|The maximum observed insulin lispro concentration following dosing.|0 to 8 hours post dose|All participants who had at least one study treatment and had evaluable PK data.|||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1415728|NCT01133392|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]|Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.|0 up to 8 hours post dose|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
1415729|NCT01133379|Secondary|Global Subjective VAS Score at Week 6|"At Week 6, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415730|NCT01133379|Secondary|Global Subjective VAS Score at Week 4|"At Week 4, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415731|NCT01133379|Secondary|Global Subjective VAS Score at Week 2|"At Week 2, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415761|NCT01132846|Secondary|Change in Clinical Stability- RED-ROSE|Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit|Baseline to 60 days|RED-ROSE was a substudy of the main ROSE trial. Only subjects consented and enrolled in RED-ROSE were included in this analysis.|||participants|||Number
1415732|NCT01133379|Secondary|Global Subjective VAS Score at Week 1|"At Week 1, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last week when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415733|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 6|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415734|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415735|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415736|NCT01133379|Secondary|Mean Cold Air Stimulus VAS Score at Week 1|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415737|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 6|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415738|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415757|NCT01132846|Secondary|Change in Treatment Response|"Treatment failure including any of the following:~development of cardio-renal syndrome~worsening/persistent heart failure~significant hypotension requiring discontinuation of study drug~significant tachycardia requiring discontinuation of study drug death"|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||participants|||Number
1415758|NCT01132846|Secondary|Change in Heart Failure Status|Persistent or worsening heart failure defined as need for rescue therapy.|randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||participants|||Number
1415739|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415740|NCT01133379|Secondary|Mean Tactile Sensitivity VAS Score at Week 1|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
1415741|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 1|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|1 Week|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
1415742|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
1415743|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
1415744|NCT01133379|Primary|Mean Tactile Sensitivity Score at Week 6|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|6 Weeks|Analysis was based on the Intent-to-Treat Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams||Standard Error|Least Squares Mean
1415745|NCT01133288|Secondary|Immune Response to Yulex|A secondary study outcome is the development of an immune response to Yulex using a human IgG anti-Guayule immunoassay. The development of a detectable IgG immune response will be considered a positive study.|3 months||||ug/ml|||Number
1415746|NCT01133288|Primary|Sensitization to Yulex|The primary study outcome will be an assessment for sensitization to Yulex as determined by serological assay for Guayule-specific IgE antibodies. The development of a detectable IgE immune response will be considered a positive study.|Approximately 3 months|No participants were exposed to Yulex because the study was terminated.|||ng/ml|||Number
1415747|NCT01133275|Secondary|Number of Participants With Grade 3 or 4 Adverse Events Possibly Related to Treatment|Grade 3 or 4 events Related/Possibly Related/Probably Related to study treatment. Number of participants with events specified in the study protocol: Neutropenia, Thrombocytopenia, Febrile Neutropenia, Infection, Sepsis, Venous Thromboembolic Events. Evaluations according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.0.|Up to 54 months|All participants|||participants|||Number
1415748|NCT01133275|Primary|Number of Participants With Erythroid Response|The rate of erythroid response to treatment with the lenalidomide/prednisone combination in non-del (5q) low and int-1 risk Myelodysplastic Syndrome (MDS) with symptomatic anemia. Hematological improvement erythroid response (HI-E) according to International Working Group (IWG) 2006 criteria.|Up to 7 months|All evaluable participants|||participants|||Number
1415749|NCT01133171|Secondary|Change in Systolic Blood Pressure||From baseline to six months||||mmHg||Standard Deviation|Mean
1415750|NCT01133171|Primary|Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk|Only the intervention patients were analyzed for this outcome.|From baseline to six-months||||percentage of patients|||Number
1415751|NCT01133067|Secondary|Cost Analysis|On average, each patient spent INR 5117.10 on travel and INR 3079.06 on lodging per follow up visit.|2 years|Patients of lung cancer treated with curative intent and on follow up with our institution|||Indian Rupees||Standard Deviation|Mean
1415752|NCT01133067|Primary|Concurrence Between the Telephonic Interview and the Physician Assessment|The Prevalence and bias adjusted Kappa (PABAK) score for concurrence between telephonic and physician assessment of disease status of each patient at each follow up visit was analysed.|2 years||||probability||95% Confidence Interval|Number
1415753|NCT01132846|Secondary|Global Visual Analog Scale Area Under the Curve|Range 0 to 7200 Higher is better/improved|Randomization to 72 hours|Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.|||units on a scale * hours||Standard Deviation|Mean
1415762|NCT01132846|Secondary|Worst Reported Symptom Changes-RED-ROSE|"To determine whether changes in worst reported symptom (WRS) (dyspnea, body swelling or fatigue) VAS (WRS-VAS) are related to the response to decongestive therapy as assessed by change in WRS VAS.~WRS range -100 to + 100 Higher number is better (improved)"|Change from Baseline to 72 hours|RED-ROSE was a substudy of the main ROSE study. Only subjects consented and enrolled in RED-ROSE were included in this analysis.|||units on a scale||Standard Deviation|Mean
1415763|NCT01132846|Secondary|Change in Weight|Change in weight from randomization to 72 hours. Secondary Endpoint|randomization to 72 hours||||lbs||Standard Deviation|Mean
1415764|NCT01132846|Primary|Cumulative Urinary Volume|The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours|Randomization to 72 hours||||mL||Standard Deviation|Mean
1415765|NCT01132846|Primary|Decongestive Changes- RED-ROSE|"To determine whether changes in pDSS or dyspnea VAS are related to the response to decongestive therapy as evidenced by fluid volume loss~Fluid volume loss is defined as cumulative urinary output minus fluid intake during the first 72 hours post randomization."|Baseline to 72 hours|RED-ROSE is a substudy of the overall ROSE study. Only consented and enrolled RED-ROSE subjects participated.|||mL||Standard Deviation|Mean
1415766|NCT01132846|Primary|Change in Dyspnea Assessment (RED-ROSE Substudy)|"To determine whether the pDSS is a more sensitive index of variability in dyspnea status than the dyspnea VAS assessed without standardization of conditions at assessment as assessed by change in Dyspnea VAS.~Dyspnea VAS range -100 to + 100 Larger number is better"|Baseline to 72 hours||||units on a scale||Standard Deviation|Mean
1415767|NCT01132846|Primary|Change in Cystatin C|The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.|Randomization to 72 hours||||mg/L||Standard Deviation|Mean
1415768|NCT01132820|Other Pre-specified|VEGFA Expression on Pre-treatment Tumor Specimens|High vs low expression.|Baseline|||||||
1415769|NCT01132820|Other Pre-specified|Plasma Levels of Endogenous Circulating VEGFA, Levels of Its Endogenous Inhibitor, sFlt-1 (the Truncated, Circulating Portion of VEGFR-1), Circulating TF, and Circulating Par-4||Up to 5 years|||||||
1415770|NCT01132820|Other Pre-specified|Levels of Receptor Targets Such as VEGFR (1, 2, 3) and PDGFR||Baseline|||||||
1415771|NCT01132820|Other Pre-specified|Expression of Phosphorylated ERK1 and 2, c-Jun, Stat3, PKC, and p70S6 Kinase||Baseline|||||||
1415772|NCT01132820|Secondary|Response Without Regard to the Time of Documented Response|Complete and partial tumor response by RECIST 1.1|Tumor responses with time restriction starts at enrollment and goes to 6 months after enrollment or until pt. off study therapy,whichever occurs first. Without time restriction starts at enrollment,lasts until off study therapy, median duration = 2.63 mth|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1415773|NCT01132820|Secondary|Progression Free Survival|Time until disease progression, death, or date of last contact.|Disease that can be assessed by physical exam should be evaluated every cycle. disease assessed by imaging should be evaluated every other cycle. Time frame to determine the date of progression is from the date of enrollment up to 5 years after enrollment|All eligible and evaluable patients|||Months||90% Confidence Interval|Median
1415774|NCT01132820|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and Treated Patients|||months||95% Confidence Interval|Median
1415775|NCT01132820|Primary|Progression-free Survival (PFS) = > 6 Months|Number of participants who survived for at least 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|For disease evaluated by physical examination, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle. Evaluated from time of enrollment until progression or death, up to 5 years|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1415776|NCT01132820|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.|For diesease evaluated by physical examination, response was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle from enrollment until stopping study therapy. The average time on study is 3 mnths|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1415777|NCT01132820|Primary|Incidence of Adverse Effects as Assessed by the National Cancer Institute CTCAE v. 4.0|Adverse Events (Grade 3 or higher)|Up to 5 years|Eligible and treated patients|||Participants|||Count of Participants
1415778|NCT01132690|Secondary|Liver Volume|Liver volume measured by MRI|Baseline and Month 12||||mL||Standard Deviation|Mean
1415779|NCT01132690|Secondary|Chemokine (C-C Motif) Ligand 18 (CCL18)|Percent change from baseline in CCL18|Every 3 months for 12 months||||Percent Change from Baseline||Standard Deviation|Mean
1415780|NCT01132690|Secondary|Platelet Count|Mean and standard deviation of platelet count per cubic mm|Baseline and 12 months||||platelets per cubic mm||Standard Deviation|Mean
1415781|NCT01132690|Secondary|Spleen Volume|Spleen volume measured by MRI|Baseline and Month 12||||mL||Standard Deviation|Mean
1415782|NCT01132690|Secondary|Chitotriosidase|Percent change from baseline in chitotriosidase|Every 3 months for 12 months||||Percent Change from Baseline||Standard Deviation|Mean
1415783|NCT01132690|Primary|Hemoglobin|median and interquartile range for change from baseline in haemoglobin|Every 3 months for 12 months||||g/dL||Inter-Quartile Range|Median
1415784|NCT01132664|Secondary|Progression Free Survival (PFS) - Based on Investigator Review Using Kaplan Meier - Phase l & ll||18 months|FAS consisted of all patients who received at least 1 dose of study drug (buparlisib). PFS analysis was not done for the BM cohort population. MTD/RP2D was not established due to premature termination of the study. In the phase ll portion of the study, PFS was analyzed only in patients with known PIK3 status, thus only 26/50 patients were analyzed.|||Months||90% Confidence Interval|Median
1415795|NCT01132547|Primary|Severity of Weight Loss|Change from Baseline in Weight Z score|Baseline and 8 weeks|Completers =|||Z score||Standard Deviation|Mean
1415785|NCT01132664|Secondary|Clinical Benefit Rate (CBR) - Phase l & ll|"CBR = patients with CR, PR or SD ≥ 24 weeks according to RECIST by the investigator.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = Disappearance of all tumor lesions; PR= >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).~CBR analysis was not done for the BM cohort population."|||Participants|||Number
1415786|NCT01132664|Secondary|Disease Control Rate (DCR) Based on Investigator Assessment- Phase l & ll|"Disease control rate (DCR) = patients with complete response (CR), partial response (PR) or stable disease (SD) as per RECIST criteria.~Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed the disease status by imaging (i.e. CT/MRI): CR = disappearance of all tumor lesions; PR = >=30% shrinkage of lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD); PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline."|18 months|"The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib).~CBR analysis was not done for the BM cohort population. DCR analysis was not done for the BM cohort population."|||Participants|||Number
1415787|NCT01132664|Primary|Overall Response Rate (ORR) - Phase ll|"Objective response rate (ORR) was defined as the rate of patients with best overall response (BOR) equal to complete response (CR) or partial response (PR) according to RECIST 1.0 from the Investigators review.~Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 assessed of the disease status by imaging (i.e. CT/MRI): Complete Response (CR) = Disappearance of all tumor lesions; Partial Response (PR)= >=30% shrinkage of lesions; Overall Response (OR) = patients with CR and PR."|18 months|The full analysis set (FAS) consisted of all patients who received at least one dose of study drug (buparlisib)|||Participants|||Number
1415788|NCT01132664|Primary|Dose Limiting Toxicity (DLT) - Phase l Only|Determination of the maximum tolerated dose (MTD) in the dose escalation part of the study was based upon the estimation of the probability of DLT in Cycle 1 in patients of the dose-determining set.|cycle 1 - 28 days|The Dose–determining set (DDS) for the determination of the MTD consisted of all patients from the safety set in the dose escalation phase who had met the minimum safety evaluation requirements and the minimum exposure criterion or had experienced DLT during Cycle 1 and were discontinued. MTD analysis was done only on the phase lb group.|||Participants|||Number
1415789|NCT01132651|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and at 2 weeks||||units on a scale||Inter-Quartile Range|Median
1415790|NCT01132651|Primary|Change in Sleep Quality as Measured by a Change in Pittsburgh Sleep Quality Index (PSQI) Survey Score|"The PSQI is a clinical survey used to measure sleep quality. Seven components related to sleep quality are scored: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Each component is scored on a scale of 0 to 3. A score of 0 is associated with better sleep quality and a score of 3 is associated with worse sleep quality. The seven component scores are summed to achieve a total PSQI score. The total PSQI score has a range of 0-21. A score of 0 is associated with better sleep quality and a score of 21 is associated with worse sleep quality.~Buysse,D.J., Reynolds,C.F., Monk,T.H., Berman,S.R., & Kupfer,D.J. (1989). The Pittsburgh Sleep Quality Index (PSQI): A new instrument for psychiatric research and practice. Psychiatry Research, 28(2), 193-213."|Baseline and at 2 weeks||||units on a scale||Inter-Quartile Range|Median
1415791|NCT01132612|Secondary|Long-term Immunogenicity Assessed by the Number of Participants Developing Anti Secukinumab Antibodies During the Trial|Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment.|up to week 351|Extension safety set: the extension safety set consisted of all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment during the extension.|||Participants|||Count of Participants
1415792|NCT01132612|Secondary|Number of Participants With at Least 50%, 75% or 90% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) and IGA Mod 2009 0 or 1 Response|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Extension weeks: 1, 25, 73 and 301 (too few data points were available to perform analysis at week 301)|Full analysis set (FAS): The FAS, which included all participants who entered the extension and to whom study drug was assigned, was considered for the analysis. Only those participants, who had evaluable data at a given time point, were analyzed at that time point.|||Number of participants|||Number
1415793|NCT01132612|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Safety was assessed by frequency of adverse events including serious adverse events.|up to week 351|Extension safety set: the extension safety set consisted of all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment during the extension.|||Participants|||Count of Participants
1415794|NCT01132547|Secondary|Pattern of Weight in the Study Population|Change from Baseline in Weight|Baseline and 8 weeks|Completers|||Kilograms||Standard Deviation|Mean
1415799|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 26 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415800|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 12 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415801|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at 6 Weeks|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415802|NCT01132508|Secondary|Knee Function and Stability: Extension Stability at Baseline|Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415803|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 78 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415804|NCT01132508|Primary|Surgeons Overall Satisfaction With Norian Drillable|The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.|Surgery||||Cases|||Number
1415805|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 52 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415806|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 26 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415807|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 12 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415808|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at 6 Weeks|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415809|NCT01132508|Secondary|Knee Function and Stability: Total Range of Motion at Baseline|Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415810|NCT01132508|Secondary|Knee Function and Stability: Extension at 78 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415811|NCT01132508|Secondary|Knee Function and Stability: Extension at 52 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415812|NCT01132508|Secondary|Knee Function and Stability: Extension at 26 Week|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415813|NCT01132508|Secondary|Knee Function and Stability: Extension at 12 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415814|NCT01132508|Secondary|Knee Function and Stability: Extension at 6 Weeks|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415815|NCT01132508|Secondary|Knee Function and Stability: Extension at Baseline|The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415816|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415817|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415856|NCT01132313|Secondary|Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment|Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment|Week 4 and 12|FAS|||Percentage of participants|||Number
1415818|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415819|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415820|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415821|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Surgery|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415822|NCT01132508|Secondary|Radiographic Parameters: Angulation (Valgus/Varus) at Baseline|"The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415823|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 78 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415824|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 52 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415825|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 26 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415826|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 12 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415857|NCT01132313|Secondary|Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment|Part 2: Sustained virological response at 4 and 24 weeks after end of treatment|4 weeks and 24 weeks after the end of treatment, up to 64 weeks|FAS|||Percentage of participants|||Number
1415827|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at 6 Weeks|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415828|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Surgery|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415829|NCT01132508|Secondary|Radiographic Parameters: Condylar Widening at Baseline|"The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415830|NCT01132508|Secondary|Radiographic Parameters: Depression at 78 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|78 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415831|NCT01132508|Secondary|Radiographic Parameters:: Depression at 52 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|52 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415832|NCT01132508|Secondary|Radiographic Parameters: Depression at 26 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|26 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415833|NCT01132508|Secondary|Radiographic Parameters: Depression at 12 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|12 weeks|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415834|NCT01132508|Secondary|Radiographic Parameters: Depression at 6 Weeks|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|6 week|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415835|NCT01132508|Secondary|Radiographic Parameters: Depression at Surgery|"The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Surgery|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415858|NCT01132313|Secondary|Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4|Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4|4 weeks|FAS|||Percentage of participants|||Number
1415859|NCT01132313|Secondary|Part 2: Time to Virological Response|Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 40 weeks|FAS|||Percentage of participants|||Number
1415836|NCT01132508|Secondary|Radiographic Parameters: Depression at Baseline|"The anatomical grading parameter depression was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline."|Baseline|Five major protocol violations were excluded in the efficacy analysis.|||participants|||Number
1415837|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
1415838|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
1415839|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
1415840|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
1415841|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
1415842|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
1415843|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Tap|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.~A tap is an instrument used to create threads in a hole drilled in bone."|Day 0 (Date of surgery)||||Cases|||Number
1415844|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: K-wire|"Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.~Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures."|Day 0 (Date of surgery)||||Cases|||Number
1415845|NCT01132508|Secondary|Pain and Function Assessed With the Lysholm Knee Scale|The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.|6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)|Five major protocol violations were excluded in the efficacy analysis.|||units on a scale||Full Range|Median
1415846|NCT01132508|Primary|Ease of Use Score Measured With a Surgeon Questionnaire: Drill|Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.|Day 0 (Date of surgery)||||Cases|||Number
1415847|NCT01132508|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device||At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative||||participants|||Number
1415848|NCT01132508|Primary|Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)|Day 0 (Day of surgery)||||Cubic Centimeters||Standard Deviation|Mean
1415849|NCT01132508|Primary|Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment|Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)|Day 0 (Day of surgery)||||Minutes||Full Range|Median
1415850|NCT01132495|Secondary|Overall MACE|Non-urgent revascularization procedures, cost and cost effectiveness, functional class, number of anti-anginal medication, rate of non-urgent revascularization, and rate of cerebrovascular event.|5 years||2018-03-31|03/2018||||
1415851|NCT01132495|Primary|Major Adverse Cardiac Event Rate (MACE)|MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.|24 Month|The primary outcome analysis was designed for Cohort A only.|||percentage of subjects with SAEs|||Number
1415852|NCT01132378|Secondary|Quadriceps Strength||2 year|||||||
1415853|NCT01132378|Primary|Knee Society Score|The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain|2 year||||score||Standard Deviation|Mean
1415854|NCT01132326|Primary|Patients With Treatment-emergent Adverse Events|Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study|up to 2 years||||participants|||Number
1415855|NCT01132313|Secondary|Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment|Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment|up to 28 weeks|FAS|||Percentage of participants||95% Confidence Interval|Number
1415860|NCT01132313|Secondary|Part 1: Time to Virological Response|Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.|From drug administration until end of drug administration, up to 4 weeks|FAS|||Percentage of participants|||Number
1415861|NCT01132313|Primary|Part 3 and 4: Sustained Virological Response (SVR)|Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 36 weeks|FAS|||Percentage of participants||95% Confidence Interval|Number
1415862|NCT01132313|Primary|Part 2: Sustained Virological Response (SVR)|Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment|From drug administration until 12 weeks after end of treatment, up to 52 weeks|FAS|||Percentage of participants|||Number
1415863|NCT01132313|Primary|Part 1: Rapid Virological Response (RVR)|Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment|4 weeks|FAS which included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1415864|NCT01132144|Secondary|Procedure Related Pain|"Pain will be assessed using a Visual Analogue Scale (VAS). We will use a 10 cm length horizontal line, anchored by word descriptors at each end: No Pain = 0 cm and Very Severe Pain = 10 cm.~This outcome will be assessed in both groups, just after endometrial injury or sham procedure."|Immediately after procedure|All women enrolled.|||cm||Standard Deviation|Mean
1415865|NCT01132144|Secondary|Three-dimensional Doppler Indices From Endometrium (VFI)|"Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) assessed from endometrium using three-dimensional Power Doppler ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.~Only VFI was reported as it is a combination of VI and FI (VFI = VI*FI/100), and currently there are several concerns about the validity of these indices.~Such indices have no scale."|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.|||index||Standard Deviation|Mean
1415866|NCT01132144|Secondary|Endometrial Volume|The total volume of endometrial tissue assessed by three-dimensional ultrasonography. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.|||cm³||Standard Deviation|Mean
1415867|NCT01132144|Secondary|Endometrial Thickness|The maximum distance perpendicular to the inter-endometrial interface from the endometrium-myometrium interface of the anterior to the posterior wall of the uterus assessed in the sagittal plane. This outcome will be assessed when at least one follicle ≥ 17mm is observed.|1 month|Women that achieved at least one follicle >17mm during ovarian stimulation.|||mm||Standard Deviation|Mean
1415868|NCT01132144|Secondary|Implantation Rate|The number of gestational sacs observed divided by the number of embryos transferred.|3 months|||||||
1415869|NCT01132144|Secondary|Miscarriage|"Loss of a clinical pregnancy before 20 completed weeks of gestational age (18 weeks after fertilization).~Note: All allocated women will be considered when assessing miscarriage rate."|9 months|The number of clinical pregnancies was used as denominator, since miscarriage is a harm that can only happen in pregnant women.|||Clinical pregnancies|||Number
1415870|NCT01132144|Secondary|Ongoing Pregnancy|"At least one fetus with heart beat after 12 weeks of gestational age.~Note: All allocated women will be considered when assessing ongoing pregnancy rate."|6 months||||participants|||Number
1415871|NCT01132144|Secondary|Clinical Pregnancy|"Pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.~Note: All allocated women will be considered when assessing clinical pregnancy rate."|3 months|All women enrolled.|||participants|||Number
1415872|NCT01132144|Primary|Live Birth|"The complete expulsion or extraction from its mother of a product of fertilization, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.~Note: All allocated women will be used as denominator when assessing live birth rate."|1 year|All women enrolled.|||participants|||Number
1415873|NCT01132118|Secondary|Triglycerides|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
1415874|NCT01132118|Secondary|HDL Cholesterol|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
1415875|NCT01132118|Secondary|LDL Cholesterol|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
1415876|NCT01132118|Secondary|Total Cholesterol|mg/dL|Baseline and Week 8||||mg/dL||Standard Deviation|Mean
1415877|NCT01132118|Secondary|HOMA-B|HOMA-B = (360 x Insulin)/(Glucose - 63)|Baseline and Week 8||||(mIU x dL)/(L x mg)||Standard Deviation|Mean
1415878|NCT01132118|Secondary|HOMA-IR|"We will examine the effect of HCQ on HOMA-IR during the active treatment phase compared with placebo phase.~HOMA-IR = (Glucose x insulin)/405"|Baseline and Week 8||||(mg x mIU)/(dL*L)||Standard Deviation|Mean
1415879|NCT01132118|Primary|Insulin Sensitivity Index|"We will examine the effect of HCQ on the Matsuda Insulin Sensitivity Index (ISI) during the active treatment phase compared with placebo phase.~ISI is based on insulin and glucose levels in a fasting state during an oral glucose tolerance test (OGTT) and is calculated as follows:~ISI (Matsuda) = 10000/√ G0 X I0 X Gmean X Imean~G0 - fasting plasma glucose (mg/dL) I0 - fasting plasma insulin (mIU/L) Gmean - mean plasma glucose during OGTT (mg/dL) Imean - mean plasma insulin during OGTT (mIU/L)"|Baseline and Week 8||||(dL x L)/(mg x mIU)||Standard Deviation|Mean
1415880|NCT01131884|Primary|Bone Mineral Density|Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis|1 year after enrollment|No analysis performed as there was only one patient who participated in this study||||||
1415909|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Air Optix Aqua|Lens wettability was assessed at each visit as Grade 4 – 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes|||eyes|Participants||Number
1415881|NCT01131676|Secondary|Percentage of Participants With the Composite Microvascular Outcome|"Composite microvascular outcome defined as:~Initiation of retinal photocoagulation~Vitreous haemorrhage~Diabetes-related blindness, or~New or worsening nephropathy defined as:~New onset of macroalbuminuria; or~Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or~Initiation of continuous renal replacement therapy, or~Death due to renal disease. Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
1415882|NCT01131676|Secondary|Percentage of Participants With New Onset Macroalbuminuria|New onset macroalbuminuria defined as UACR >300 mg/g. Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
1415883|NCT01131676|Secondary|Percentage of Participants With New Onset Albuminuria|"New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
1415884|NCT01131676|Secondary|Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)|Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.|From randomisation to individual end of observation, up to 4.6 years|TS|||percentage of participants|||Number
1415885|NCT01131676|Secondary|Percentage of Participants With Silent MI|"Silent MI; defined as presence in the ECG of:~Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3~Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF)~R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect.~It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS (evaluable cases)|||percentage of participants|||Number
1415886|NCT01131676|Secondary|Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris|"The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS|||percentage of participants|||Number
1415887|NCT01131676|Primary|Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.|"Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke.~Percentage of patients with the event are presented."|From randomisation to individual end of observation, up to 4.6 years|TS|||percentage of participants|||Number
1415888|NCT01131585|Primary|Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12|Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant’s refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.|12 months|Full Analysis Set consisted of all participants who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. No patient completed the 12 months observational period due to study early termination; therefore, the last observation carried forward (LOCF) method was used with data from 11.1 months.|||Letters||Standard Deviation|Mean
1415889|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|12 month post-baseline||||units on a scale||Standard Error|Least Squares Mean
1415890|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|6 month post-baseline||||units on a scale||Standard Error|Least Squares Mean
1415891|NCT01131520|Secondary|Hair Testing|Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.|12 month post-baseline|The sample includes participants who provided usable hair testing data at baseline|||predicted probability of positive test||Standard Error|Least Squares Mean
1415892|NCT01131520|Secondary|Hair Testing|The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.|6 month post-baseline|The sample includes participants who provided usable hair testing data at baseline.|||predicted probability of positive test||Standard Error|Least Squares Mean
1415893|NCT01131520|Secondary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.|12 months post-baseline||||units on a scale||Standard Error|Least Squares Mean
1415894|NCT01131520|Secondary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.|6 month post-baseline||||units on a scale||Standard Error|Least Squares Mean
1415895|NCT01131520|Secondary|Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale|HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|3 months post-baseline||||units on a scale||Standard Error|Least Squares Mean
1415896|NCT01131520|Primary|Hair Testing|The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)|3 month post-baseline|The number of participants of the total sample who agreed to provide an analyzable hair specimen. Hair testing was not available for subjects not interviewed, those who refused testing, or who were unable to provide a sufficient quantity of hair for testing.|||Participants|||Count of Participants
1415897|NCT01131520|Primary|Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score|The ASSIST's Global Continuum of Illicit Drug Risk was used. A higher score is considered more severe risk. The scores range from 0 to 308.|3 months post-baseline||||units on a scale||Standard Error|Least Squares Mean
1415898|NCT01131507|Secondary|Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12|Participant’s ability to thrive was evaluated through growth percentiles for weight-for-age, length-for-age and weight-for-length recorded on Center for Disease Control and Prevention (CDC) growth charts during each treatment visit.|Baseline, Month 3, 6, 9 and 12|Safety population included all participants who received at least 1 dose of study drug. Here, 'n' specifies number of participants who were evaluable for various categories at each time point.|||growth percentile||Full Range|Median
1415899|NCT01131507|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE’s relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild [minimal/no treatment and did not interfere with daily activities], moderate [resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning] and severe [interrupted participant’s usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating]) with a frequency threshold of above 5% were reported.|Up to Month 12 or early termination|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
1415900|NCT01131494|Primary|Oropharyngeal Swallowing Score|Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group.|five weeks||||Scores on a scale||Standard Deviation|Mean
1415901|NCT01131494|Secondary|Quality of Life|Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life.|five weeks||||scores in a scale||Inter-Quartile Range|Median
1415902|NCT01131455|Primary|CT Scan for Fusion Analysis|There will be no outcome analysis for the CT scan performed on the 10 patients due to the death of the primary investigator.|8 weeks post op.|||||||
1415903|NCT01131299|Secondary|Lipoprotein Insulin Resistance Index (LIRI) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|LIRI was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks|The LIRI score is a composite of six lipoprotein parameters (VLDL, HDL and LDL, and concentrations of large VLDL, large HDL and small LDL subclasses) measured by NMR spectroscopy, which may be apparent years before the onset of overt hyperglycemia. LIRI scores range from zero, the most insulin sensitive, to 100, the most insulin resistant.|||percentage||Standard Error|Mean
1415904|NCT01131299|Secondary|Serum Glucose Levels After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Serum glucose levels was measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks||||mg/dL||Standard Error|Mean
1415905|NCT01131299|Secondary|Small LDL Particle Number (by NMR Spectrometry of Lipoproteins) After 12-14 Weeks Intervention, Compared to Baseline for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Small LDL particle numbers were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks||||nmol/L||Standard Error|Mean
1415906|NCT01131299|Primary|Total Serum Cholesterol Levels for Alpha-cyclodextrin (a-CD) and Placebo Groups After 12-14 Weeks, Compared to Baseline|Total cholesterol levels were measured at the end of each study arm (a-CD or placebo). a-CD (2g) was taken orally three times a day for 12-14 weeks. Placebo (2 tablets) was taken orally for 12-14 weeks. There was a one-week washout period between each arm.|24-28 weeks||||mg/dL||Standard Error|Mean
1415907|NCT01131182|Secondary|Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.|||Proportion of participants|||Number
1415908|NCT01131182|Primary|Proportion of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.|30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)|All participants as treated population consisted of all randomized participants who received at least one dose of study treatment and returned at least one completed diary card during the Ramadan period.|||proportion of participants|||Number
1416291|NCT01128192|Primary|Change in Basal Endogenous Glucose Production (EGP)|Change from Day 3 and Day 10 of Basal EGP (Hyperinsulinemic-Euglycemic Clamp)|Day 3 and Day 10||||mg/kg/min||Standard Deviation|Mean
1415910|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Acuvue Oasys|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible, dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
1415911|NCT01131130|Primary|Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens|Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.|7 days|All eligible dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
1415912|NCT01131130|Secondary|Lens Wettability, Test Lens vs. Acuvue Oasys|Lens wettability was assessed at each visit as Grade 4 – 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).|7 days|All eligible, dispensed eyes|||eyes|Participants||Number
1415913|NCT01131104|Primary|30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use|Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.|30 days prior to NAION onset|All participants in the 30 day analysis set.|||Relative risk of exposure|Participant days|95% Confidence Interval|Number
1415914|NCT01131078|Secondary|Duration of Overall Complete Response|Duration of complete response was calculated as the time in months from the date of randomization to the date of first documentation of CR. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years|ITT Population; Only participants with a best overall response were included in the analysis.|||months||95% Confidence Interval|Median
1415915|NCT01131078|Secondary|Duration of Stable Disease (SD)|Duration of SD was calculated as the number of months the participants remained in CR, PR or SD. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a best overall response of CR, PR, or SD were included in the analysis.|||months||95% Confidence Interval|Median
1415916|NCT01131078|Secondary|Duration of Overall Response|Duration of overall response included participants who achieved a CR or PR.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a best overall response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1415917|NCT01131078|Secondary|Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment|Early progression was the proportion of participants with progressive disease within 12 weeks from the start of treatment.|Randomization, Weeks 3, 6 and 9, and 12|ITT Population; All participants with evaluable data were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1415918|NCT01131078|Secondary|Percentage of Participants With Stable Disease|Stable disease rate was the proportion of participants who achieved CR, PR, or SD.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1415919|NCT01131078|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis|||percentage of participants||95% Confidence Interval|Number
1415920|NCT01131078|Secondary|Percentage of Participants by Best Overall Response|Best overall response is defined as the best response recorded from the date of randomization until disease progression or recurrence. Complete response (CR): at least 2 determinations of CR at least 4 weeks apart before progression; Partial response (PR): at least 2 determinations of PR at least 4 weeks apart before progression; Stable disease (SD): at least one SD assessment; Progressive Disease (PD): Disease progression or death due to underlying cancer. CR: Complete disappearance of all target lesions; PR: At least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions; PD: At least 20% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of longest diameter of all target lesions or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for CR or PR or increase in lesions;|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; All participants with evaluable data were included in the analysis|||percentage of participants|||Number
1415921|NCT01131078|Primary|Time to Progression (TTP)|TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only those participants with an event of disease progression or death were included in the analysis|||months||95% Confidence Interval|Median
1415922|NCT01131078|Secondary|Time to Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a time to progression event (excluding deaths not related to underlying cancer) were included in the analysis.|||months||95% Confidence Interval|Median
1415923|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer|The failure event was defined as tumor progression excluding only deaths not related to underlying cancer.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
1415924|NCT01131078|Secondary|Time to Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason. Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with a time to progression event (excluding deaths) were included in the analysis.|||months||95% Confidence Interval|Median
1415925|NCT01131078|Secondary|Percentage of Participants With Progression Excluding Deaths|The failure event was defined as tumor progression excluding deaths due to any reason.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
1415968|NCT01130844|Primary|Time to Maximum Plasma Concentration (Tmax) of MMX Mesalamine (5-ASA) at Steady State|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over a 24-hour period starting on day 7|PKS|||hours||Full Range|Median
1415926|NCT01131078|Secondary|Time to Treatment Failure|Time to treatment failure is defined as a composite endpoint measuring time from date of randomization to discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent. Analysis was performed using Kaplan-Meier estimates.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; only participants with a treatment failure event were included in the analysis.|||months||95% Confidence Interval|Median
1415927|NCT01131078|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, death, treatment toxicity, insufficient therapeutic response, failure to return, refusing treatment, being unwilling to cooperate and withdrawing consent.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
1415928|NCT01131078|Secondary|Overall Survival|Overall survival is defined as the time from date of randomization until death from any cause; Kaplan-Meier estimates were used for analysis.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population; Only participants with an event (death) were included in the analysis.|||months||95% Confidence Interval|Median
1415929|NCT01131078|Secondary|Percentage of Participants Who Died|Overall survival is defined as the time from date of randomization until death from any cause|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population|||percentage of participants|||Number
1415930|NCT01131078|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.|Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death|ITT Population;|||percentage of participants|||Number
1415931|NCT01131065|Secondary|Safety and Tolerance|Safety and tolerance to the product administration will be measured by the detection of adverse events or clinically relevant changes in vital signs.|During and after each product administration (during the 12 month treatment period)||||participants|||Number
1415932|NCT01131065|Primary|HBsAb Pre-infusion Levels (Trough Levels Before Each Niuliva Administration)||Days 3 to 7, Weeks 2 to 4, Months 2 to 6, and Months 7 to 12||||IU/L||Standard Deviation|Mean
1415933|NCT01131065|Primary|HBV Recurrence|HBV recurrence is measured by seroconversion or reappearance of HBsAg and HBV DNA positivity|First six and twelve months after liver transplantation||||participants|||Number
1415934|NCT01131052|Primary|Mean of Weekly Fasting Blood Glucose Concentration|Mean weekly blood glucose concentration at 3 months|3 months||||mg/dL||Standard Deviation|Mean
1415935|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|6 months||||percent of glycosylated hemoglobin||Standard Deviation|Mean
1415936|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|3 months||||percent of glycosylated hemoglobin||Standard Deviation|Mean
1415937|NCT01131052|Secondary|Mean of Daily Blood Glucose Concentration|Mean of daily blood glucose concentration at baseline|Baseline||||mg/dL||Standard Deviation|Mean
1415938|NCT01131052|Secondary|Mean of Glycosylated Hemoglobin (hbA1c)|Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person’s blood glucose levels have been. A normal A1C level is below 5.7 percent.|Baseline||||percent of glycosylated hemoglobin||Standard Deviation|Mean
1415939|NCT01131052|Secondary|Mean Blood Glucose Concentration|Mean blood glucose concentration at baseline|Baseline||||mg/dL||Standard Deviation|Mean
1415940|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL|Mean weekly blood glucose concentration less than 40 mg/dL at 3 months|3 months||||percentage of participants|||Number
1415941|NCT01131052|Primary|Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL|Mean weekly blood glucose concentration less than 70 mg/dL at 3 months|3 months||||percentage of participants|||Number
1415942|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|2 week and 1 month follow-up|All eligible, dispensed eyes|||logMAR|Participants|Standard Deviation|Mean
1415943|NCT01130974|Secondary|Symptoms & Complaints|Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.|Summarized over all follow-up visits through one month|All eligible dispensed eyes, summarized over all follow-up visits through 1 month.|||units on a scale|Participants|Standard Deviation|Mean
1415944|NCT01130974|Secondary|Lens Movement|Lens movement was assessed as adequate, excessive (> 0.6 mm), insufficient (< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
1415945|NCT01130974|Secondary|Lens Centration|"Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift).~Suboptimal lens centration was defined as a rating other than excellent."|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
1415946|NCT01130974|Secondary|Lens Deposits|Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month|Summarized over all follow-up visits through one month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
1419179|NCT01106157|Secondary|Change in Insulin Autoantibodies (IAA) From Baseline to 12 Months|Change in Insulin Autoantibodies (IAA) over 12 months|Change from baseline to 12 months||||Units/mL||Standard Deviation|Mean
1415947|NCT01130974|Secondary|Lens Wettability|Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas > 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|Summarized over all follow-up visits through 1 month|All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.|||eyes|Participants||Number
1415948|NCT01130974|Primary|logMAR Visual Acuity (VA)|Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit|Summarized over all visits, and dispensed visit|All eligible, dispensed eyes|||logMAR|Participants|Standard Deviation|Mean
1415949|NCT01130974|Primary|Slit Lamp Findings|Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) > grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe|Summarized over all follow-up visits through 1 month|All dispensed eyes with any slit lamp findings > grade 2|||eyes|Participants||Number
1415950|NCT01130883|Secondary|Termination of Treatment Due to Noncompliance|Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.|Day 8 - 16|A total of 3128 participants were included in the analysis.|||Participants|||Number
1415951|NCT01130883|Secondary|Compliance|Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.|Day 8 - 16||||Participants|||Number
1415952|NCT01130883|Secondary|Study Drug Given as the First, Second or Third Antimicrobial Treatment|Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.|Day 0||||Participants|||Number
1415953|NCT01130883|Secondary|Chest X-ray in Case of Community-Acquired Pneumonia (CAP)|Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.|Day 0|Chest X-ray was performed in 294 of the participants for whom the physician suspected pneumonia.|||Participants|||Number
1415954|NCT01130883|Secondary|Auscultation|Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, auscultation findings were not reported for 38 participants at the initial visit and 116 participants at the final visit.|||Participants|||Number
1415955|NCT01130883|Secondary|Dyspnea and Its Type|Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).|Day 0, Day 8-16||||Participants|||Number
1415956|NCT01130883|Secondary|Cough and Its Character|Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)|Day 0, Day 8-16||||Participants|||Number
1415957|NCT01130883|Secondary|Bacteriological Investigation (if Available)|The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.|Day 0|Of the 3128 participants included in the analysis, 225 participants had bacteriological investigations conducted at the Initial visit (Day 0). Some participants had more than one finding.|||participants|||Number
1415958|NCT01130883|Secondary|Body Temperature|Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).|Day 0, Day 8-16|Of the 3128 participants included in the analysis, body temperature was not reported for 6 participants at the Initial visit, and 14 participants at the Second visit.|||Participants|||Number
1415959|NCT01130883|Primary|Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)|Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. “Regression of chest X-ray findings” were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).|Day 0, Day 8 - 16||||participants|||Number
1415960|NCT01130883|Primary|Disappearance or Significant Alleviation of Symptoms|"Overall therapeutic response, yes or no was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response."|Day 8 - 16|A total of 3130 participants were enrolled into the study and 3128 were included in the analysis. Two participants were excluded from the analysis as they did not meet entry criteria (2 participants were less than 18 years of age).|||Participants|||Number
1415961|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine Major Metabolite (Ac-5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS|||mg||Standard Deviation|Mean
1415962|NCT01130844|Secondary|Cumulative Amount of MMX Mesalamine (5-ASA) Recovered in Urine at Steady State||Over a 24-hour period starting on day 7|PKS|||mg||Standard Deviation|Mean
1415963|NCT01130844|Primary|CL of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS|||L/h||Standard Deviation|Mean
1415964|NCT01130844|Primary|Tmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS|||hours||Full Range|Median
1415965|NCT01130844|Primary|Cmax of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||Over a 24-hour period starting on day 7|PKS|||ug/L||Standard Deviation|Mean
1415966|NCT01130844|Primary|AUC of MMX Mesalamine Major Metabolite (Ac-5-ASA) at Steady State||2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|PKS|||ug*h/L||Standard Deviation|Mean
1415967|NCT01130844|Primary|Total Body Clearance (CL) of MMX Mesalamine (5-ASA) at Steady State|Clearance of a substance from the blood by the kidneys.|Over a 24-hour period starting on day 7|PKS|||L/h||Standard Deviation|Mean
1415969|NCT01130844|Primary|Maximum Plasma Concentration (Cmax) of MMX Mesalamine (5-ASA) at Steady State|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over a 24-hour period starting on day 7|PKS|||ug/L||Standard Deviation|Mean
1415970|NCT01130844|Secondary|Percentage of Dose Absorbed For MMX Mesalamine (5-ASA) in Urine at Steady State|The percentage of the dose absorbed was calculated as: 100 x (Xu0-24h 5-ASA + [0.7847* Xu0-24h Ac-5-ASA])/dose, where 0.7847 is the ratio of the molecular weight of 5-ASA (153.14) to the molecular weight of Ac-5-ASA (195.15). Xu0-24h is equal to the cumulative amount recovered in urine in the time interval of 0 to 24 hours.|Over a 24-hour period starting on day 7|PKS|||percentage of dose absorbed||Standard Deviation|Mean
1415971|NCT01130844|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|2, 4, 6, 9, 12, 16, and 24 hours post-dose on day 7|The Pharmacokinetic Set (PKS) consisted of all subjects in the Safety Analysis Set who generated sufficient plasma samples to allow reliable determination of Cmax and AUC. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ug*h/L||Standard Deviation|Mean
1415972|NCT01130831|Secondary|Number of Tablets Per Day||12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior|||Number of Tablets||Standard Deviation|Mean
1415973|NCT01130831|Secondary|Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||mg||Standard Deviation|Mean
1415974|NCT01130831|Secondary|Change From Baseline in Vitamin D Dose at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||ng||Standard Deviation|Mean
1415975|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate|Hypercalcemia defined as total serum calcium above 11.22 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415976|NCT01130831|Secondary|Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy|Hypercalcemia is defined as total serum calcium level above 11.22 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415977|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415978|NCT01130831|Secondary|Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy|Hypocalcemia is defined as serum calcium levels below 8.02 mg/dL|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415979|NCT01130831|Secondary|Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=38) for this outcome which does not allow for any meaningful comparison.|||percent change in vitamin D||Standard Deviation|Mean
1415980|NCT01130831|Secondary|Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy. Note that there are a high number of missing values (n=36) for this outcome which does not allow for any meaningful comparison.|||percent change in vitamin D||Standard Deviation|Mean
1415981|NCT01130831|Secondary|Percent Change From Baseline in iPTH Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in iPTH levels||Standard Deviation|Mean
1415982|NCT01130831|Secondary|Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in calcium-phosphorous||Standard Deviation|Mean
1415983|NCT01130831|Secondary|Percent Change From Baseline in Calcium Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in calcium levels||Standard Deviation|Mean
1415984|NCT01130831|Secondary|Percent Change From Baseline in Phosphorous Levels at 12 Months||Baseline and 12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percent change in phosphorous levels||Standard Deviation|Mean
1415985|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy|iPTH levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for iPTH of 150-300 pg/mL|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415986|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
1415987|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415988|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415989|NCT01130831|Secondary|Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects|||Number
1415990|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
1415991|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy|Calcium-phosphorous product levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium-phosphorous product of <55 mg^2/dL^2.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
1415992|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|12 months|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
1415993|NCT01130831|Secondary|Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy|Calcium levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum calcium of 8.4-9.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
1415994|NCT01130831|Primary|Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy|Phosphorous levels are controlled if they meet the Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous of 3.5-5.5 mg/dL.|Baseline|Full Analysis Set included subjects of the Safety Analysis Set who had values for serum phosphorous, serum calcium, and intact parathyroid hormone (iPTH) while on prior calcium-based phosphate binder therapy.|||percentage of subjects||95% Confidence Interval|Number
1415995|NCT01130740|Secondary|PHQ-8|This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.|12-months||||units on a scale||Standard Error|Mean
1415996|NCT01130740|Secondary|Short Physical Performance Test Protocol|"This is a series of 5 tests covering the domains of balance (3 tests), gait speed (8 foot walk) and time to rise from a chair and return to the seated position five times. The total score ranges from 0 (worst performance) to 12 (best performance).~The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months||||units on a scale||Standard Error|Mean
1415997|NCT01130740|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from none (0) to severe / extreme (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section."|12-months|All enrolled participants were analyzed, on an intent to treat basis. One enrolled participants in the Usual Care grouped changed clinical care to an enrolled OA Intervention provider after randomization, so that participant was analyzed with the OA intervention group.|||units on a scale||Standard Error|Mean
1415998|NCT01130597|Secondary|Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline||Baseline and Day 56|Participants with urine ACR ≥ 30 mg/g at baseline and available data at Week 8|||mg/g||Standard Error|Mean
1416017|NCT01130532|Secondary|"Change From Week 12 to Week 16 Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 3"|"Assessed the percentage of Yes responses to the SEP diary Question 3 Did your erection last long enough for you to have successful intercourse? from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment)."|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||"percentage of yes responses"||Standard Deviation|Mean
1416018|NCT01130532|Secondary|Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function.|12 weeks and 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Deviation|Mean
1416019|NCT01130532|Secondary|Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).|12 weeks through 16 weeks|"All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||percentage of participants|||Number
1416020|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) – Partner Satisfaction With Medication Score at Week 12 Endpoint|The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416021|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner|The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416022|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)|Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416023|NCT01130532|Secondary|Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint|The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.|Week 12|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416032|NCT01130493|Secondary|"Total On With No Troublesome Dyskinesia"|"Using a Parkinson's disease diary, subjects recorded a state of “asleep”, ”OFF”, “ON without dyskinesia,” “ON with non-troublesome dyskinesia,” or “ON with troublesome dyskinesia” every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.~Mean Total On with No Troublesome Dyskinesia was calculated. On Time is when medication is providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2|||hours||Standard Deviation|Mean
1424063|NCT01064323|Primary|Brachial Flow Velocity|Measured using ultrasound, units cm/sec.|5 minutes into leg intermittent pneumatic compression||||cm/sec||Standard Deviation|Mean
1416024|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient|The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416025|NCT01130532|Secondary|"Change From Baseline to 12-Week in Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 1-5"|Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||"percentage of yes responses"||Standard Error|Least Squares Mean
1416026|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score|Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416027|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score|Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416028|NCT01130532|Secondary|Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.|Baseline, 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||units on a scale||Standard Error|Least Squares Mean
1416029|NCT01130532|Primary|Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)|Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).|Baseline through 12 weeks|"All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used."|||percentage of participants|||Number
1416030|NCT01130493|Secondary|Subject Preference|Subjects who completed both treatments were asked to indicate a preference for Treatment Period 1 or Treatment Period 2 or no preference. Preferences for a particular treatment period were mapped to the associated treatment and reported.|End of Study (week 11)|Participants who completed both treatment periods|||Participants|||Count of Participants
1416031|NCT01130493|Secondary|UPDRS Part II Plus Part III|"Unified Parkinson’s Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination). Part II consists of 14 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 72. Part III consists of 27 questions, each ranges from 0 (Normal/None) - 4 (Worst) with a total score of 0 - 108.~The UPDRS Part II Plus Part III scores ranged from 0 (no problems with daily living or mobility) to 180 (severe problems with daily living and mobility."|End of each double-blind treatment period.|Participants who completed both treatment periods|||Scores on a scale||Standard Deviation|Mean
1416033|NCT01130493|Secondary|Total “OFF” Time During Waking Hours|"Using a Parkinson's disease diary, subjects recorded a state of “asleep”, ”OFF”, “ON without dyskinesia,” “ON with non-troublesome dyskinesia,” or “ON with troublesome dyskinesia” every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.~Mean Total Off Time During Waking Hours was calculated. Off Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2|||hours||Standard Deviation|Mean
1416034|NCT01130493|Primary|Percentage of “OFF” Time During Waking Hours|"Using a Parkinson's disease diary, subjects recorded a state of “asleep”, ”OFF”, “ON without dyskinesia,” “ON with non-troublesome dyskinesia,” or “ON with troublesome dyskinesia” every 30 minutes over a 24-hour day for the last 3 days of each double-blind crossover treatment period.~Mean percentage of “OFF” Time During Waking Hours was calculated. Off Time is Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness."|3 days of data immediately prior to the end of each 2 week treatment period|Participants who completed both treatment periods and completed PD diary for both Period 1 and Period 2|||Percent||Standard Deviation|Mean
1416035|NCT01130337|Secondary|Percentage of Participants With Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.|||percentage of participants|||Number
1416036|NCT01130337|Secondary|Percentage of Participants With Complete Tumor Resection (R0)|R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|"ITT population. Here number of participants analyzed included those who underwent surgery."|||percentage of participants||95% Confidence Interval|Number
1416037|NCT01130337|Secondary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.|Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25|ITT population.|||percentage of participants||95% Confidence Interval|Number
1416038|NCT01130337|Primary|Percentage of Participants With Disease-free Survival (DFS) at Month 18|DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).|Month 18|ITT population.|||percentage of participants||95% Confidence Interval|Number
1416039|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416040|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment|Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416041|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416042|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment|Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416043|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment|Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose DBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416044|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment|Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose DBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416045|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment|Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the multiple dose SBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416046|NCT01130168|Primary|TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment|Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose SBP analysis."|||mm mercury (Hg)||Standard Deviation|Least Squares Mean
1416047|NCT01130168|Primary|Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 24 hours after the Day 28 dose|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for two participants in the ISM ER treatment group, therefore these participants were excluded from the multiple dose AIx analysis."|||percent||Standard Deviation|Least Squares Mean
1416048|NCT01130168|Primary|Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment|"The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:~HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses."|Baseline (0 hrs), 12 hours post-dose (Day 1)|"33 participants completed all study periods and provided more than 1 period of BP data, and were thus evaluable for the BP analyses.~Unreliable SphygmoCor® data were collected for one participant in the ISM ER treatment group, therefore this participant was excluded from the single dose AIx analysis."|||percent||Standard Deviation|Least Squares Mean
1416049|NCT01130103|Primary|Number of Participants Who Met Remission Criterion|remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1|Weeks 5,10|all participants who were randomized, with people who dropped out counted as non-remitters|||participants|||Number
1416050|NCT01130103|Secondary|Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10|Measures life enjoyment and satisfaction across 16 domains 16 = very poor quality of life to 80 =very good quality of life|weeks 0,5,10|observed data at weeks 0, 5, and 10|||units on a scale||Standard Deviation|Mean
1416051|NCT01130103|Secondary|Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms|total score at weeks 0, 5, 10|weeks 0,5,10|observed data at each time point|||units on a scale||Standard Deviation|Mean
1416052|NCT01130103|Secondary|Treatment Response at Weeks 5 and 10|"responder status: CGI-change score of 1 or 2~1=very much improved, 2= much improved"|weeks 5,10|all subjects randomized with dropouts carried forward as nonresponders|||participants|||Number
1416053|NCT01130103|Primary|Clinician Administered PTSD Scale (CAPS)|PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD|Weeks 0,5,10|all participants who were randomized|||units on a scale||Standard Deviation|Mean
1416054|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.|||ng-hr/mL||Standard Deviation|Mean
1416055|NCT01130051|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.|||ng-hr/mL||Standard Deviation|Mean
1424064|NCT01064323|Primary|Brachial Flow Velocity|Brachial flow velocity measured using ultrasound. Units cm/sec.|Baseline||||cm/sec||Standard Deviation|Mean
1416056|NCT01130051|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 13 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period 2 dosing for personal reasons. Two subjects were discontinued from the study before Period 2 for protocol violations.|||ng/mL||Standard Deviation|Mean
1416057|NCT01129960|Primary|Change From Baseline to Endpoint in Mean Pain|Study was prematurely halted. The efficacy analysis was restricted to the primary efficacy variable in the interim analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (31st October 2011), was the basis for the efficacy analysis; patients with less than 20 days of study medication were excluded from the analysis, except those with early discontinuation. Primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [“0” = no pain; “10” = the most intense pain imaginable]|baseline up to endpoint 15 weeks (3-week titration phase and 12-week treatment maintenance phase)|FAS = Full Analysis Set (comprised all randomized subjects with mean pain score at baseline and mean score after randomization; subjects with less than 20 days of study medication of the cut-off date were excluded from the dataset, except those that prematurely withdrew; this was the primary population used in the efficacy analysis)|||units on a scale||Standard Error|Least Squares Mean
1416058|NCT01129921|Primary|Visual Analog Scale (VAS) Mean Improvement|VAS ten point scale where 0 = no pain and 10 represents worst pain imaginable. Mean improvement of two or more points is considered clinically relevant. The mean improvement from Baseline to Year-1 is presented below for the two treatment groups.|Baseline and Year 1|All patients who reported Year-1 outcomes (Year-1 Cohort) were analyzed. The Sham Year-1 cohort represent those original Sham patients who crossed over from Sham to the mild procedure and were then followed for one year.|||units on a scale||Standard Deviation|Mean
1416059|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|"VAS as measured on a 10-point scale. A score of 4 or less after treatment is considered favorable, as it indicates pain is less than the moderate to severe categories represented by scores of 5 to 10. All patients in each arm who reported a pain score of 4 or less at Week 6-12 and Year 1 are reported below."|Week 6 to 12 & Year One After Sham to mild x-over|Patients who reported Year 1 outcomes are reported at Week 6-12 and at Year 1. All findings reported below for the Sham group are after cross-over to mild.|||participants|||Number
1416060|NCT01129921|Primary|Visual Analog Scale (VAS) <=4|Using VAS, pain is measured on a 0 to 10 point scale where 0 represents no pain and 10 indicates severe pain. A post-treatment score of 4 points is the accepted threshold between a “mild” pain score of 1-3 points and a “moderate to severe” pain score of 5 to 10 points which represents debilitating pain that would qualify the patient for a different or additional treatment option. All patients in each arm who reported a pain score of 4 or less at six to twelve weeks post-treatment are reported below.|Week 6 to 12 prior to cross-over|All 40 participants (20 in each arm) reported VAS at six weeks to twelve weeks post-treatment. All measurements for the sham group occurred prior to cross-over to the mild procedure. Patients with scores of 4 or less in each study group are reported below. This is Intent to Treat (ITT)analysis.|||participants|||Number
1416061|NCT01129778|Secondary|Reflux Disease Questionnaire Score on Day 1 After Therapy Completion|The RDQ is a 12 item survey that asks the patient to rate the frequency and severity of GERD symptoms. Each item is scored from 0 to 5 where a score of 0 is equivalent to an asymptomatic state and 5 indicates the worst severity of GERD symptoms. The total RDQ is a sum of all 12 items, and can range from 0 to 60.|Day 1 after therapy period completion|Participants who completed all protocol-specified assessments were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1416062|NCT01129778|Primary|Percentage of Time Esophageal pH< 4|Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH <4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique.|Days 1 and 2|Participants who completed all protocol-specified assessments were included in the analysis.|||percentage of hours||Standard Deviation|Mean
1416063|NCT01129765|Secondary|Number of Patients Experiencing a Physical Injury During Use|"After the procedure, the patient was directly examined for any of the following:~bleeding from the nostrils~disruption of the skin around the nose~increased work of breathing/respiratory distress (increased respiratory rate, increased respiratory accessory muscle use)"|Day one, immediately|This is the total number of participants, all of whose children were examined after the procedure.|||paricipants|||Number
1416064|NCT01129765|Secondary|Number of Patients Who Were Observed to Have an Adverse Event|"While using the device, the patients were observed by the research coordinator for any of the following adverse events to occur:~bloody nose~being sprayed in the eye with the saline~vomiting after the procedure~choking during or after the procedure~other"|Day one, immediately||||patients with an adverse event|||Number
1416065|NCT01129765|Secondary|Number of Participants Who Identified the Device's User Manual as Easy to Understand|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.~The question and scale are as follows: How easy was the manual to understand?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately||||participants|||Number
1416066|NCT01129765|Primary|Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device|"'Proper use' is defined as successfully completing all of the following five steps:~Attaching wash-head to handle properly~Positioning child correctly for procedure as per the user manual's instructions~Using the device's control button correctly for both irrigation and aspiration~Placing the wash-head tip correctly at the nasal opening~Using the device for up to but not exceeding five seconds"|Day one, immediately||||participants|||Number
1416085|NCT01129557|Primary|Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.|The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.|9 months||||participants|||Number
1416067|NCT01129765|Secondary|Number of Participants Who Found the Device to be Effective|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.~The question and scale are as follows: How well did the device remove nasal secretions?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately||||participants|||Number
1416068|NCT01129765|Secondary|Number of Participants Who Experienced Ease of Use With the Device|"After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. An answer of 3 or greater is considered an affirmative answer. Such responses reported along with the exact 95% confidence intervals.~The question and scale are as follows: How easy was the device to use?~1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy"|Day one, immediately|This was the total number of participants who answered this question.|||participants|||Number
1416069|NCT01129622|Secondary|Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole|The number of participants who developed short term hypoestrogenic side effects or other adverse effects of letrozole during the intake of the medication or in the following week.|Three days plus One Week following medication|All entered subjects|||Number of participants|||Number
1416070|NCT01129622|Primary|Number of Women With Reduced Breast Parenchymal Enhancement|Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc − SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.|One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement|All participants who completed two MRIs were analysed. Percentage reduction in breast enhancement compared to baseline was determined.|||Number of participants|||Number
1416071|NCT01129583|Secondary|Broberg Morrey Composite Elbow Function Score|Composite elbow function store that takes into account range of motion, stability, strength, and pain. Score ranges from 0 (worse possible function) to 100 (best possible function).|6 months post-op||||Score||Standard Error|Mean
1416072|NCT01129583|Secondary|Elbow Range of Motion|Elbow flexion/extension active range of motion was assessed with the use of a standard goniometer with the center placed over the lateral epicondyle and the arms aligned with the long axis of the humerus and ulna, respectively. Full extension (arm completely straight) is defined as 0 degrees, and peak flexion is measured as the angle formed by the arm and forearm compared to a full straight arm.|3 months post-op||||Degrees||Standard Error|Mean
1416073|NCT01129583|Primary|Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire|"The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a questionnaire designed to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb.~The DASH is scored in two components: the disability/symptom questions (30 items, scored 1-5) and the optional high performance sport/music or work section (4 items, scored 1-5). The DASH disability/symptom score (0-100) is calculated by averaging all the scores, subtracting one and multiplying by 25. A score of 0 represents no disability, while 100 represents maximum possible disability."|1 year post-op||||Scores on a Scale (0-100)||Standard Error|Mean
1416074|NCT01129557|Secondary|Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(ng/dL)||Standard Deviation|Mean
1416075|NCT01129557|Secondary|Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine aldosterone for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(ug/day)||Standard Deviation|Mean
1416076|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine sodium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(mmol/day)||Standard Deviation|Mean
1416077|NCT01129557|Secondary|Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) 24-hour urine protein for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(mg/day)||Standard Deviation|Mean
1416078|NCT01129557|Secondary|Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum potassium for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||(mmol/L)||Standard Deviation|Mean
1416079|NCT01129557|Secondary|Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) serum creatinine for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||mg/dL||Standard Deviation|Mean
1416080|NCT01129557|Secondary|Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.|Compares baseline and final (9 month) blood pressure for subjects with and without aldosterone breakthrough|Baseline and Final (9 month)||||mm Hg||Standard Deviation|Mean
1416081|NCT01129557|Secondary|Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean 24-hour urine sodium (mmol/day) at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months||||mmol/day||Standard Deviation|Mean
1416082|NCT01129557|Secondary|Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum potassium at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)|Baseline, 3-, 6-, and 9-months||||mmol/L||Standard Deviation|Mean
1416083|NCT01129557|Secondary|Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean urine aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months||||ug/day||Standard Deviation|Mean
1416084|NCT01129557|Secondary|Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.|Mean serum aldosterone at baseline, 3-, 6-, and 9-months.|Baseline, 3-, 6-, and 9-months||||ng/dL||Standard Deviation|Mean
1416086|NCT01129531|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia|Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||Score on a scale||Standard Deviation|Mean
1416087|NCT01129531|Secondary|Change From Baseline in Area of Allodynia|A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||cm^2||Standard Deviation|Mean
1416088|NCT01129531|Secondary|Change From Baseline in Area of Spontaneous Pain|A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||cm^2||Standard Deviation|Mean
1416089|NCT01129531|Primary|Change From Baseline in the Average Pain Intensity Score at Week 12|Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified intent to treat population included all randomized participants who received treatment and had at least 1 post-baseline pain intensity score.|||Score on a scale||Standard Deviation|Mean
1416090|NCT01129336|Secondary|Change From Baseline in Urine NTX by Month|NTX= N-telopeptide of type 1 collagen (nmol bce/mmol [nanomoles of bone collagen equivalents per millimole of creatinine]). Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or visit 2 value for patients who did not receive study drug.|Baseline, Month 2, Month 4|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.|||nmol bce/mmol||Standard Deviation|Mean
1416091|NCT01129336|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from the date of enrollment to the date of first documented disease progression or death due to metastatic breast cancer.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.|||Days||95% Confidence Interval|Median
1416092|NCT01129336|Secondary|Percentage of Patients With Circulating Tumor Cell Levels of at Least 5 Per 7.5 mL of Peripheral Blood by Month|Circulating tumor cells (CTCs) have been associated with poor patient prognosis and outcomes in patients receiving treatment for MBC. CTCs have been evaluated as a potential biomarker for predicting treatment effects and overall survival. Baseline was defined as the last predose measurement for patients who received any study drug and as the later of the screening visit or Visit 2 value for patients who did not receive the study drug. Percentage was calculated as the number of patients with CTC ≥5/7.5 mL against the number of patients with nonmissing CTC values (represented as 'n' in the categories).|Baseline, Month 1, 2, 4, 6, 9 and 18|"All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug. n in each category represents the number of patients with non-missing CTC values."|||Percentage of Participants||95% Confidence Interval|Number
1416093|NCT01129336|Primary|Number of Participants With Progression Free Survival (PFS)|Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to < 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum diameters. PFS is time from enrollment to date of first documented disease progression or death due to any cause. A participant is considered to be censored when data on time to event is missing due to a subject being lost to follow-up or non-occurrence of the outcome event before the completion of the trial.|up to 18 months|All Enrolled Patients population, which included all enrolled patients regardless of whether they received study drug.|||Participants|||Number
1416094|NCT01129284|Secondary|Sustained Remissions up to 1 Year After Discontinuing Therapy|Complete remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at last follow-up visit (6 to 12 months post treatment). Partial remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at last follow-up visit (6 to 12 months post treatment).|Up to 1 year after treatment||||participants|||Number
1416095|NCT01129284|Primary|Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)|Complete remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at month 6. Partial remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at month 6.|6 months||||participants|||Number
1416096|NCT01129245|Secondary|Change in Luteal Phase Progesterone Levels|progesterone levels during study|completion of study (1 year)|||||||
1416097|NCT01129245|Primary|Menstrual Length When Taken After Ovulation: Extended Luteal Phase|average menstrual cycle length in days during active drug exposure|Completion of study (1 year)||||days||Standard Deviation|Mean
1416098|NCT01129206|Secondary|Correlation of FDG PET Response With Response Rate|Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.|Approximately three years|2 patients not evaluable for response applying the PERCIST criteria per PET|||patients|||Number
1416099|NCT01129206|Secondary|Overall Survival (OS)|OS was determined from the date of start of therapy to death frm any cause.|Approximately five years||||months||95% Confidence Interval|Median
1416100|NCT01129206|Secondary|Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Approximately three years||||months||95% Confidence Interval|Median
1416101|NCT01129206|Primary|Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Approximately three years||||patients|||Number
1416102|NCT01129141|Primary|Tinnitus Functional Index|The TFI served as the primary outcome measure. The TFI is a 25-item self-report questionnaire that has documented validity both for scaling the severity and negative impact of tinnitus, and for measuring treatment-related changes in tinnitus (responsiveness) (Meikle et al., 2012). The total score for the TFI ranges from 0 to 100, with higher scores indicating greater problems with tinnitus. The TFI has excellent internal consistency (Cronbach’s α = .97) and high test-retest reliability (r = .86) (Meikle et al., 2012). The authors of the TFI estimated that a 13-point decrease on the TFI for an individual is likely to reflect a change that feels meaningful to the person.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
1416103|NCT01129128|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events such as nausea or rash in participants receiving an Echinacea formulation or placebo will be compared|1- 30 days after starting study medication|Participants who received at least one dose of study medication|||participants|||Number
1416104|NCT01129128|Secondary|Peak Level IL-2|Highest level of IL-2 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-2 level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
1416105|NCT01129128|Secondary|Peak Level Interferon Gamma|Highest level of Interferon gamma while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who Interferon gamma level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
1416106|NCT01129128|Secondary|Peak Level IL-6|Highest level of IL-6 while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who IL-6 level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
1416107|NCT01129128|Primary|Peak Level of TNF Alpha|Highest level of TNF alpha while taking study medication|1-10 days after starting study medication|Data analyzed on any participant who TNF alpha level was obtained on 1 or more days while on study medication.|||pg/ml||Standard Deviation|Mean
1416108|NCT01129115|Primary|Change in Physical Performance Test|The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.|26 Week||||units on a scale||Standard Deviation|Mean
1416109|NCT01129115|Primary|Change in Maximal Oxygen Consumption|Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness|26 weeks||||ml/kg/min||Standard Deviation|Mean
1416110|NCT01129115|Secondary|Reasoning|"Reasoning is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests:Letter and Word Inductive Reasoning, Matrix Reasoning.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks||||units on a scale||Standard Error|Mean
1416111|NCT01129115|Secondary|Set Maintenance & Shifting|"Set Maintenance and Switching is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: DKEFS Card Sort, Animal and Vegetable Category Fluency.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks||||units on a scale||Standard Error|Mean
1416112|NCT01129115|Secondary|Simple Attention|"Simple Attention is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Digit span Forward and Backward, Letter Numbers Sequencing.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 Weeks||||units on a scale||Standard Error|Mean
1416113|NCT01129115|Primary|Visuospatial Processing|"Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance. Negative numbers indicate worsening performance."|26 weeks||||units on a scale||Standard Error|Mean
1416166|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS2 (LOCF dataset)|||mg||Standard Deviation|Mean
1416114|NCT01129115|Secondary|Verbal Memory|"Verbal Memory is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Logical Memory, Delayed Logical Memory, Selective Reminding Task - Free Recall Total, Boston Naming Test.~Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores. Positive number indicate improved performance.Negative numbers indicate worsening performance."|26 weeks|Healthy older adults without measurable cognitive decline who did not meet recommended daily activity levels.|||units on a standardized scale||Standard Error|Mean
1416115|NCT01129102|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks|This analysis was carried out based on FAS population. IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available in IKH-01 group.|||units on a scale||Standard Deviation|Mean
1416116|NCT01129102|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea.|||units on a scale||Standard Deviation|Mean
1416117|NCT01129011|Secondary|Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales|Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
1416118|NCT01129011|Secondary|Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales|Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35.|baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
1416119|NCT01129011|Secondary|Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales|"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47"|Baseline to 6 Months|Intent to Treat (ITT) Population|||Units on SODA Subscale||Standard Error|Least Squares Mean
1416120|NCT01129011|Secondary|Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire|"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group."|change from baseline at 6 Months|Intent to Treat Population|||Participants|||Number
1416121|NCT01129011|Secondary|Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population|||participants|||Number
1416122|NCT01129011|Secondary|The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment|The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period|6 months|Intent to treat (ITT) population|||Participants|||Number
1416123|NCT01129011|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer|The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period|6 Months|Intent to Treat (ITT) Population|||Participants|||Number
1416124|NCT01129011|Secondary|The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers|The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort|6 months|Intent to Treat (ITT) Population|||Participants|||Number
1419118|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set|||percentage of participants|||Number
1416125|NCT01129011|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||Participants|||Number
1416126|NCT01128972|Other Pre-specified|Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent SMH||Standard Error|Least Squares Mean
1416127|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent NER||Standard Error|Least Squares Mean
1416128|NCT01128972|Other Pre-specified|Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent SMH||Standard Error|Least Squares Mean
1416129|NCT01128972|Other Pre-specified|Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent NER||Standard Error|Least Squares Mean
1416130|NCT01128972|Secondary|Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline, 4 hours post treatment in each treatment period.|PP population: All randomized participants who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent SMH||Standard Error|Least Squares Mean
1416131|NCT01128972|Primary|Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who received at least one dose of the study treatments and had no major protocol deviations were included in analysis.|||Percent NER||Standard Error|Least Squares Mean
1416132|NCT01128959|Primary|Adverse Events||Baseline to after last iv dose on day 4|All Patients Treated Set|||Number of adverse events|||Number
1416384|NCT01127581|Secondary|Incidence of Pre-delivery Oxytocin During the First Hospital Admission|Percentage of participants in receipt of Oxytocin for induction after study drug removal.|At least 30 minutes after study drug removal|Analysis population includes subjects who delivered during the first hospitalization.|||percentage of participants||95% Confidence Interval|Number
1416133|NCT01128946|Secondary|Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.|||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Mean
1416134|NCT01128946|Secondary|%SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|PP population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group|||Percentage||Standard Error|Mean
1416135|NCT01128946|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/(D-B)]*100.|Baseline to 14 days|Per Protocol (PP) population: All randomized participants, who received at least one dose of study treatment and with at least one post-baseline efficacy assessment but did not have any major protocol violations. Missing data was not imputed. Due to drop outs, there were differences in number of participants (N) per treatment group.|||Percentage of SMHR||Standard Error|Mean
1416136|NCT01128894|Secondary|Mean Change From Baseline in Body Weight at Week 32|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline weight as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.|||Kilograms||Standard Deviation|Mean
1416137|NCT01128894|Secondary|Time to Hyperglycemia Rescue at Week 32|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: fasting plasma glucose (FPG) >=280 milligram/decilitre (mg/dL) >= Week 2 and < Week 4, FPG >=250 mg/dL >= Week 4 and <Week 12, HbA1c ≥8.5% and ≤0.5% reduction from Baseline- >= Week 12 and <Week 26, or HbA1c ≥8.5% >= Week 26. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus one day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus one day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. All times extending beyond Week 32 relevant to hyperglycemia rescue were censored at Week 32.|Week 32|ITT Population|||Weeks||95% Confidence Interval|Median
1416138|NCT01128894|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 32|Number of participants who achieved HbA1c response levels of <6.5% and <7.0% at Week 32 were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 32|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
1416139|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 6, 12, 18 and 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 1, 2, 3, 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1416400|NCT01127165|Secondary|Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)|The difference of K-QOLCE between before and after the administration. K-QOLCE is Korean version of the Quality of Life in Childhood Epilepsy Questionnaire. The calculated total score ranges 0-100, with higher scores indicating higher quality of life.|Baseline and 24 weeks||||Scores on a Scale||Standard Deviation|Mean
1416140|NCT01128894|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, Baseline HbA1c category, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline FPG as a continuous covariate. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline and Week 32|ITT Population. Only those participants available at the indicated time point were assessed.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1416141|NCT01128894|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 6, 12, 18 and 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were considered in the treatment week if they had received at least one dose in that treatment week.|Baseline, Weeks 4, 6, 12, 18 and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1416142|NCT01128894|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 32|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 32 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 32|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1416143|NCT01128829|Primary|The Effect of Sucralose on Insulin Concentration (Area Under the Curve; AUC)|we will measure plasma insulin concentrations during a 5-hour modified Oral Glucose Tolerance Test (mOGTT) administered 10 minutes after subjects consume sucralose in water or an equal volume of water without sucralose (control condition).Plasma insulin concentrations were measured at 20, 15, 10, 6, and 2 min before and at 10, 20, 30, 40, 60, 90, 120, 150,180, 240, and 300 min after ingesting 75g of glucose. All these data collected were used to create the AUC curve.|Baseline||||(pmol • min •L-1)||Standard Deviation|Mean
1416144|NCT01128738|Secondary|Duration of Effect|Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of >50% production in gravimetric assessment compared to Baseline.|Up to Week 40|FAS1|||days||95% Confidence Interval|Median
1416145|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase|Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416146|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416201|NCT01128621|Primary|Mean Accumulation Ratio by AUC (0-10), AUC (0-24) and Cmax for GSK1292263 (Part B)|Accumulation ratio (Ro) was derived as: Ro = Day 14 morning AUC(0-10)/Day 1 morning AUC(0-10) (for BID regimens only). Ro = Day 14 AUC(0-24)/Day 1 AUC(0-24) (for both BID and once daily regimens). Accumulation ratio (RCmax)= Day 14 Cmax/Day 1 Cmax. RCmax was not computed for each dosing period (morning and evening).|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||90% Confidence Interval|Mean
1416147|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416148|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416149|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416150|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416151|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416152|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416168|NCT01128738|Secondary|Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase|The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416153|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416154|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416155|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416156|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416157|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416158|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416167|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase|FAS for the Second Treatment Phase (FAS2) (LOCF dataset): all participants who were included in the FAS1, received the second treatment of IP, and had at least one efficacy assessment after the second treatment. One participant who started the Second Treatment Phase was not included in the FAS2 because they had no efficacy assessment in this phase.|||percentage of participants|||Number
1416159|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416160|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416161|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416162|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416163|NCT01128738|Secondary|Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||scores on a scale||Standard Deviation|Mean
1416164|NCT01128738|Secondary|Percentage of Responders Assessed by the HDSS in the Second Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2.|Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase|FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||percentage of participants|||Number
1416165|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) * 100/mean weight at Baseline in the Second Treatment Phase.|Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase||||percent change||Standard Deviation|Mean
1416421|NCT01126671|Primary|Follow-up 25OHD Levels|After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.|12 weeks||||ng/ml||Standard Deviation|Mean
1416169|NCT01128738|Secondary|Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416170|NCT01128738|Secondary|Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416171|NCT01128738|Secondary|Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416172|NCT01128738|Secondary|Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1 The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416173|NCT01128738|Secondary|Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416174|NCT01128738|Secondary|Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416175|NCT01128738|Secondary|Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416422|NCT01126671|Primary|Baseline 25 Hydroxy Vitamin D (25OHD) Levels|25OHD will be drawn at baseline prior to starting vitamin D supplementation.|Baseline||||ng/ml||Standard Deviation|Mean
1416176|NCT01128738|Secondary|Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416177|NCT01128738|Secondary|Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416178|NCT01128738|Secondary|Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416179|NCT01128738|Secondary|Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416180|NCT01128738|Secondary|Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416181|NCT01128738|Secondary|Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416182|NCT01128738|Secondary|Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416202|NCT01128621|Primary|T1/2 Following Repeat Dose of GSK1292263 (Part B)|"Outcome measure was added with caveat as data permits. The data for T1/2 was not collected."|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK population||||||
1416183|NCT01128738|Secondary|Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416184|NCT01128738|Secondary|Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416185|NCT01128738|Secondary|Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416186|NCT01128738|Secondary|Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.|||scores on a scale||Standard Deviation|Mean
1416187|NCT01128738|Secondary|Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase|The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2.|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40|FAS1. The number of participants remaining in the study at the time of the visit, particularly regardless of reinjection after Week 16, was used as the denominator. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.|||percentage of participants|||Number
1416188|NCT01128738|Secondary|Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) * 100/mean weight at Baseline.|Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.|||percent change||Standard Deviation|Mean
1416189|NCT01128738|Secondary|Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.|Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.|||milligrams (mg)||Standard Deviation|Mean
1416190|NCT01128738|Secondary|Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Weeks 1, 8 ,12, 16, 20, and 24|FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.|||percentage of participants|||Number
1419180|NCT01106157|Secondary|Change in Glutamic Acid Decarboxylase Antibodies (GADA) From Baseline to 12 Months|Change in Glutamic Acid Decarboxylase Antibodies (GADA) over 12 months|Change from baseline to 12 months||||nmol/L||Standard Deviation|Mean
1416191|NCT01128738|Primary|Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase|A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.|Week 4|Full Analysis Set for the First Treatment Phase (FAS1): all participants who received the first treatment of investigational product (IP) and had at least 1 post-Baseline efficacy assessment. The analysis was performed using the Last Observation Carried Forward (LOCF) dataset; missing data were imputed by carrying forward the last available data.|||percentage of participants|||Number
1416192|NCT01128621|Primary|Number of Participants With Relationship Between GSK1292263 Drug Exposures and Pharmacodynamic Parameters (Part B)|Data was not collected for this outcome measure.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose|PD Population. No data was collected for this outcome measure.||||||
1416193|NCT01128621|Primary|Change From Baseline in Weighted Mean for Insulin Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline. AUC with respect to that time interval was calculated using the linear trapezoidal rule. The weighted mean was determined by dividing the AUC by the observed length of the collection interval (time of last assessment – time of first assessment in hours). In order for the AUC to be calculated, the first and last time points and at least one additional assessment falling between the two must be non-missing.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population|||pmol/L||95% Confidence Interval|Mean
1416194|NCT01128621|Primary|Change From Baseline in Weighted Mean for Glucose Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline. Weighted mean were assessed for (0-12) and (0-24). AUC with respect to that time interval was calculated using the linear trapezoidal rule. The weighted mean was determined by dividing the AUC by the observed length of the collection interval (time of last assessment – time of first assessment in hours). In order for the AUC to be calculated, the first and last time points and at least one additional assessment falling between the two must be non-missing.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||mmol/L||95% Confidence Interval|Mean
1416195|NCT01128621|Primary|Mean Post Meal Insulin Value (Part B)|Blood samples were collected on Days -1 and 14, post-breakfast at 0.5, 1, 1.5, 2 and 3 hours post dose. For lunch (approximately 4 hours post morning dose) samples were collected at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hours post morning dose), samples were taken at 0.5, 1, 1.5, 2 and 3 hours post dinner.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||pmol/L||95% Confidence Interval|Mean
1416196|NCT01128621|Primary|Mean Post Meal Glucose Value (Part B)|Blood samples were collected on Days -1 and 14, post-breakfast at 0.5, 1, 1.5, 2 and 3 hours post dose. For lunch (approximately 4 hours post morning dose) samples were collected at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hours post morning dose), samples were taken at 0.5, 1, 1.5, 2 and 3 hours post dinner.|At pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||mmol/L||95% Confidence Interval|Mean
1416197|NCT01128621|Primary|Change From Baseline in Mean Fasted Insulin Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||pmol/L||95% Confidence Interval|Mean
1416198|NCT01128621|Primary|Change From Baseline in Mean Fasted Glucose Value (Part B)|Baseline was considered to be Day -1 pre-breakfast value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Days -1 and 14, and then at 0.5, 1, 1.5, 2 and 3 hours post dose.|PD Population.|||mmol/L||95% Confidence Interval|Mean
1416199|NCT01128621|Primary|Change From Baseline in Mean Fasted Insulin Value (Part A)|Baseline was considered to be Day 1 pre-breakfast. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Day 1 and 24 hours post-dose.|PD Population. Only those participants with data available at the indicated time points were analyzed.|||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
1416200|NCT01128621|Primary|Change From Baseline in Mean Fasted Glucose Value (Part A)|Baseline was considered to be Day 1 pre-breakfast. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline is set to missing as well. If measurements were taken in triplicate, then the mean of the triplicate measurements was used as the Baseline.|Baseline and at pre-breakfast on Day 1 and 24 h post-dose.|The Pharmacodynamic (PD) Population included participants from the Safety Population who had any PD parameter estimated. Only those participants with data available at the indicated time points were analyzed.|||millimoles per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
1416788|NCT01124162|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1416203|NCT01128621|Primary|AUC From Time Zero (Pre-dose) to 10 Hours [AUC (0-10)] and AUC (0-24) Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. AUC (0-10) and AUC (0-24) were determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1416204|NCT01128621|Primary|Tmax and Tlag Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. Tmax was determined directly from the raw concentration-time data. Tlag was determined as the time of the sample preceding the first quantifiable concentration, on Day 1 only.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
1416205|NCT01128621|Primary|Cmax Following Repeat Dose of GSK1292263 (Part B)|Serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1, 7 and 14. Blood samples for PK were collected on Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, blood samples for PK were collected at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen). When planned PK sampling resulted in multiple samples at the same time point, only one sample was collected. The PK parameters were calculated by standard non-compartmental analysis. Cmax was determined directly from the raw concentration-time data.|On Days 1 and 14, at immediately pre-morning dose, 1, 2, 4, 6, 8, 10, 11, 12, 14, 16, 18, 24 and 48 hours post-morning dose. On Day 7, at pre-dose (post-breakfast), 1, 2, 4 (pre-lunch), 6 and 10 (immediately post-dinner, pre-dose for BID regimen).|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1416206|NCT01128621|Primary|Terminal Phase Half-life (t1/2) Following a Single Dose of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for t1/2 was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population||||||
1416207|NCT01128621|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) Following a Single Dose of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for AUC (0-inf) was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population||||||
1416208|NCT01128621|Primary|Volume of Distribution (V/F) (Part A)|"Outcome measure was added with caveat as data permits. The data for V/F was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population||||||
1416209|NCT01128621|Primary|Apparent Clearance Following Oral Dosing (CL/F) of GSK1292263 (Part A)|"Outcome measure was added with caveat as data permits. The data for CL/F was not collected."|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|||||||
1416210|NCT01128621|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) and Time of Occurrence of Cmax (Tmax) Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of PK were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for 2 participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. Tmax was determined directly from the raw concentration-time data. Tlag was determined as the time of the sample preceding the first quantifiable concentration, on Day 1 only.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||hour||Full Range|Median
1416211|NCT01128621|Primary|Maximum Observed Concentration (Cmax) Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of PK were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. Cmax was determined directly from the raw concentration-time data.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1416212|NCT01128621|Primary|Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours [AUC (0-24)] and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-last)] Following a Single Dose of GSK1292263 (Part A)|Blood samples for the determination of pharmacokinetics (PK) were collected on Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose. PK samples for 2 participants were not analyzed. The PK parameters were calculated by standard non-compartmental analysis. AUC (0-last) and AUC (0-24) were determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|On Day 1 Immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13, 24 and 48 hours post-dose.|The PK Population included participants from the Safety Population who had any PK parameter estimated. Only those participants with data available at the indicated time points were analyzed.|||nanograms hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1416213|NCT01128621|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Part B)|ECGs were taken at Screening, pre-breakfast on Day -1 and at Follow-up. On Days 1, 7 and 14 ECGs were taken pre-breakfast (fasting) and at 1, 2, 4, 6, 8, 12 and 24hours post-dose. Triplicate ECGs were taken at the pre-breakfast time point, and single assessments were taken at all other times. ECGs were taken in supine position. The data has been presented as abnormal- not clinically significant (NCS) and abnormal-clinically significant (CS).|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1416214|NCT01128621|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Part A)|ECGs were taken at Screening, pre-breakfast on Day -1, on Day 1 (pre-breakfast, 1 hour, 2, 3, 4, 6, 8, 13, 24hours post-dose), and at follow-up. Assessments were made in triplicate on Day 1 at the pre-breakfast time point, and single assessments were made at all other times. ECGs were taken in supine position. The data has been presented as abnormal- not clinically significant (NCS) and abnormal-clinically significant (CS).|Up to 10 days after discharge (Day 2) in Part A|Safety Population.|||Participants|||Count of Participants
1416215|NCT01128621|Primary|Number of Participants With Abnormal Vital Signs of PCI (Part B)|Assessment of vital signs (including systolic and diastolic blood pressure and heart rate) was performed at Screening, pre-breakfast on Days -1 to 14 in a fasting state early in the morning (prior to morning dosing on Days 1-14), and at Follow-up. On Days 1, 7 and 14, they were taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes.|Up to 10 days after discharge (Day 15) in Part B|Safety Population.|||Participants|||Count of Participants
1416216|NCT01128621|Primary|Number of Participants With Abnormal Vital Signs of PCI (Part A)|Assessment of vital signs (including systolic, diastolic blood pressure and heart rate) was performed at one time point at Screening, at follow-up and pre-breakfast on Day -1. On Day 1, they were taken at pre-breakfast, 1 hour, 3, 4, 6, 10, 16 and 24 hours post-dose. Assessments were made in triplicate at the pre-breakfast time point, and single assessments were made at all other times. Assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. PCI value of systolic blood pressure: <85 and >160 millimeter of mercury (mmHg). PCI value of diastolic blood pressure: <45 and >100 mmHg. PCI value of heart rate: <40 and >110 beats per minute.|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
1416217|NCT01128621|Primary|Mean Value of Urine Specific Gravity (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urinalysis parameter include urine specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine . It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine .|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1416218|NCT01128621|Primary|Mean Value of Urine Specific Gravity (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urinalysis parameter include urine specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine . It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine .|Up to 10 days after discharge (Day 2) in Part A|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
1416219|NCT01128621|Primary|Mean Value of Urine pH (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urinalysis parameters included urine pH assessed using dipstick analysis. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||pH||Standard Deviation|Mean
1416220|NCT01128621|Primary|Mean Value of Urine pH (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urinalysis parameters included urine pH assessed using dipstick analysis. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral.|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||pH||Standard Deviation|Mean
1416221|NCT01128621|Primary|Mean Value of Urine Albumin (Part B)|Urine samples were collected at screening, on Day -2, and on Days 1, 7, 15 and at follow-up. Urine albumin was assessed using quantitative analysis.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||mg/L||Standard Deviation|Mean
1416222|NCT01128621|Primary|Mean Value of Urine Albumin at Follow up (Part A)|Urine samples were collected at screening, Day -1, at 24hr post- dose (Day 2), and at follow-up. Urine albumin was assessed using quantitative analysis.|Up to 10 days after discharge (Day 2) in Part A|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||milligrams per liter (mg/L)||Standard Deviation|Mean
1416223|NCT01128621|Primary|Number of Participants With Abnormal Urinalysis Data Values (Part B)|Urinalysis parameters: Urine occult blood, Urine glucose, Urine ketones, Urine protein, White blood cells were assessed for abnormal findings by dipstick analysis. The abnormal findings were presented as trace, 1+, 2+ and 3+. Trace indicates lowest concentration of the mentioned parameters in urine and 3+ indicates highest concentration. Concentration of 3+ indicates worse outcome.|Up to 10 days after discharge (Day 15) in Part B|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1416224|NCT01128621|Primary|Number of Participants With Abnormal Urinalysis Data Values by Dipstick Method (Part A)|Urinalysis parameters: Urine occult blood, Urine Glucose, Urine ketones and Urine protein were assessed for abnormal findings by dipstick analysis. The abnormalities were presented as trace, 1+, 2+ and 3+. Trace indicates lowest concentration of the mentioned parameters in urine and 3+ indicates highest concentration. Concentration of 3+ indicates worse outcome.|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
1416841|NCT01123642|Secondary|Clinician Administered PTSD Scale (CAPS-5)|Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).|one year|Sample sizes differ across time points due to attrition and missing data.|||score on a scale||Standard Deviation|Mean
1416225|NCT01128621|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCI (Part B)|Blood samples for chemistry assessments were collected at screening, on Day -2 (non-fasting), and prior to breakfast (early in the morning, fasting) on Days 1, 7, and on Day 15 prior to checkout, (=24hrs post-dose), and at follow-up. Clinical chemistry parameters: Aspartate amino transferase (unit: international unit per liter [IU/L]) and Total bilirubin (unit: micromoles per liter (µmol/L) were assessed for abnormal values of PCI. For aspartate aminotransferase the PCI range was >=2 x ULN (high). For total bilirubin the PCI range was >=1.5 x ULN (high).|Up to 10 days after discharge (Day 15) in Part B|Safety Population|||Participants|||Count of Participants
1416226|NCT01128621|Primary|Number of Participants With Abnormal Clinical Chemistry Values of PCI (Part A)|"Blood samples for chemistry assessments were collected at screening, fasting (Day -1), at 24hr post- dose (morning of Day 2), and at follow-up.~Clinical chemistry parameter: Glucose (unit: millimoles per liter [mmol/L]) was assessed for abnormal high value of PCI. The normal range was 3.6 to 5.5 mmol/L"|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
1416227|NCT01128621|Primary|Number of Participants With Abnormal Hematology Values of PCI (Part B)|Blood samples for hematology assessments were collected at screening, on Day -2 (non-fasting), and prior to breakfast (early in the morning, fasting) on Days 1, 7, and on Day 15 prior to checkout, (=24hrs post-dose), and at follow-up. Hematology parameters: Hematocrit (unit: ratio) and hemoglobin (unit: grams per liter [g/L]), were assessed for abnormal values of PCI. The PCI range for hematocrit was: >0.075 decrease from Baseline (low), >1.02 x upper limit normal (ULN) (high-male), >1.17 x ULN (high-female). The PCI range for hemoglobin was: >25 decrease from Baseline (low), >1.03 x ULN (high-male), >1.13 x ULN (high-female). Data has been presented for the number of participants with hematology data values high from the PCI range in a consolidated format.|Up to 10 days after discharge (Day 15) in Part B|Safety Population|||Participants|||Count of Participants
1416228|NCT01128621|Primary|Number of Participants With Abnormal Hematology Values of Potential Clinical Importance (PCI) (Part A)|Blood samples for hematology assessments were collected at screening, fasting (Day -1), at 24hr post- dose (morning of Day 2), and at follow-up. Hematology parameter: Total Neutrophil count was assessed for abnormal value of PCI. The range of PCI value was: <0.83 x lower limit normal (LLN) with unit x10^9 per liter|Up to 10 days after discharge (Day 2) in Part A|Safety Population|||Participants|||Count of Participants
1416229|NCT01128621|Primary|Number of Participants With Any AEs and Serious Adverse Events SAEs (Part B)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to 10 days after discharge (Day 15) in Part B|Safety Population|||Participants|||Count of Participants
1416230|NCT01128621|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) (Part A)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to 10 days after discharge (Day 2) in Part A|Safety Population consisted of all participants enrolled in the study and who had received at least one dose of study drug.|||Participants|||Count of Participants
1416231|NCT01128595|Primary|EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1416232|NCT01128595|Primary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1419063|NCT01106833|Secondary|Prednisone Dose|Daily dose of prednisone is described by treatment arm at baseline, 6 months, and 1 year post-randomization.|Up to 1 Year Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/kg/day||Full Range|Median
1416233|NCT01128595|Primary|LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1416234|NCT01128595|Secondary|Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% fall in FEV1 from the saline value was achieved. After inhalation of saline, 3 measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.|Day 22 of each treatment period (up to Study Day 198)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||milligrams per milliliter||Standard Deviation|Mean
1416235|NCT01128595|Secondary|Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Maximum percent change was calculated as the minimum FEV1 minus the saline FEV1 value divided by the saline FEV1 multiplied by 100. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline FEV1 value.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population. Only those participants available at the specified time points were analyzed.|||percent change||Full Range|Median
1416236|NCT01128595|Primary|Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period|Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.|Day 21 of each treatment period (up to Study Day 197)|Efficacy Population: all participants who received at least one dose of study medication, had a post-dose FEV1 assessment, and who were not major protocol violators. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1416237|NCT01128569|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.|From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)|ITT Population|||participants|||Number
1416238|NCT01128569|Secondary|Minimum FEV1 Absolute Change From Baseline Between 0–2 Hour, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0–2 hour, following the 22–23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model ANCOVA with fixed effects of treatment, period, participant-level Baseline, period level Baseline, country, sex, and age.|||Liters||Standard Error|Least Squares Mean
1416251|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1424284|NCT01061606|Primary|Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST||Up to 3 years||||participants|||Number
1416239|NCT01128569|Secondary|Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, participant-level BL, period level BL, country, sex, and age. Change from BL was calculated as the value on Day 29 minus the BL value.|||Percent change||Standard Error|Least Squares Mean
1416240|NCT01128569|Primary|Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0–2 Hours, Following the 22–23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.|Baseline and Day 29 of each treatment period (up to Study Day 197)|Intent-to-Treat (ITT) Population: par. randomized to treatment who received >=1 dose of study drug. Only those par. available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, par.-level Baseline, period level Baseline, country, sex, and age.|||Liters||Standard Error|Least Squares Mean
1416241|NCT01128543|Secondary|Duration of Response|Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a >=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter.|From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)|All participants randomized to receive at least one dose of study drug. Only those participants with a complete or partial response were evaluated.|||months||Inter-Quartile Range|Median
1416242|NCT01128543|Secondary|Progression-free Survival|Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.|||months||Standard Deviation|Mean
1416243|NCT01128543|Primary|Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24|Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for >=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started.|Week 12 and Week 24|All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.|||participants|||Number
1416244|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416270|NCT01128296|Secondary|Overall Survival (OS) by CA 19-9 Response|Median number of months of overall survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or, no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%.|Up to 35 months|Analysis population included participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response|||months||95% Confidence Interval|Median
1416245|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416246|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416247|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416248|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416249|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416250|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1424557|NCT01059760|Primary|Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1416252|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416253|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416254|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416255|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416256|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416257|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department|Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416287|NCT01128192|Primary|Change in High-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in High-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10||||mg/kg/min||Standard Deviation|Mean
1416288|NCT01128192|Primary|Change in Low-Dose Glucose Disposal Rate (GDR)|Change from Day 3 and Day 10 in Low-Dose Glucose Disposal Rate (GDR) during Hyperinsulinemic-Euglycemic Clamp.|Day 3 and Day 10||||mg/kg/min||Standard Deviation|Mean
1416258|NCT01128426|Primary|Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient|Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows.|30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)|Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.|||ratio||90% Confidence Interval|Number
1416259|NCT01128413|Primary|Lactate Clearance|The median lactate clearance from time zero to within 6 hours of the ED stay.|The median lactate clearance within 6 hours of the ED stay.|Only 9 total patients (5 Fluid Optimization; 4 Routine Care) stayed in the Emergency Department for a full 6 hours to allow calculation of a 6 hour lactate clearance. The rest of the patients left were dispositioned out of the ED before the 6 hour mark and therefore unable to calculate a 6 hour lactate clearance.|||percent lactate clearance||Inter-Quartile Range|Median
1416260|NCT01128400|Primary|Triolein Detection|We will measure triolein detection levels as a marker of subjects' ability to detect triglyceride. Triolein taste detection thresholds were separately assessed using a three-alternative forced-choice (i.e. 3-AFC) ascending concentration.|Ranges from 5 days after screening to several weeks, pending availablity of participant.||||log10 (%W/V TRIOLEIN)||Standard Error|Mean
1416261|NCT01128400|Primary|Oleic Acid Detection Level|We will measure oleic acid detection levels as a marker of subjects' ability to detect free fatty acids. Oleic acid taste detection thresholds were separately assessed using a three-alternative forced-choice (i.e. 3-AFC) ascending concentration.|Ranges from 5 days after screening to several weeks, pending availablity of participant.||||log10 (%W/V OLEIC ACID)||Standard Error|Mean
1416262|NCT01128387|Secondary|Pathologic Response|From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post Radiation (XRT)/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information|20 weeks.|Data was not collected or analyzed for the pathologic response outcome measure.||||||
1416263|NCT01128387|Primary|MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT|Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting >7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation >10 treatment days, 2) >2 interruptions of radiation per course, 3) a delay in completion of radiation by >14 days beyond planned treatment schedule, 4) inability to deliver >80% of planned treatment doses, 5) any infield grade 4 toxicity|approximately 18 weeks||||Participants|||Count of Participants
1416264|NCT01128361|Primary|Cornell Scale for Depression in Dementia|The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.|Week 0, 13, and 26|Linear mixed models were used with all available data. Overall numbers analyzed may not reflect numbers at each timepoint|||units on a scale||Standard Deviation|Mean
1416265|NCT01128361|Primary|Disability Assessment for Dementia|This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.|Week 0, 13, and 26|Linear mixed models were used with all available data. Overall number of participants may not match numbers at each timepoint.|||percentage on a scale||Standard Deviation|Mean
1416266|NCT01128361|Primary|Executive Function Composite|"A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged.~Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores."|Week 0, 13, and 26|Linear mixed models were used with all available data included. Overall numbers analyzed do not necessarily match the outcome measure at each timepoint|||standardized units on a scale||Standard Deviation|Mean
1416267|NCT01128361|Primary|Memory Composite|"A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged.~Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores."|week 0, 13, and 26|Linear mixed models with all available data were used. Thus the overall number of participants analyzed does not necessarily match the means reported at each timepoint.|||units on a standardized scale||Standard Deviation|Mean
1416268|NCT01128296|Secondary|Overall Survival (OS) by p53 Mutant Status||Up to 35 months|Participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
1416269|NCT01128296|Secondary|Disease-free Survival by p53 Genetic Status||Up to 35 months|Participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
1419183|NCT01106157|Secondary|Percent Change in Regulatory T Cells (Treg) Baseline to 12 Months|Change in regulatory T cells (Treg) baseline to 12 months|Change in Baseline to 12 months||||percentage change||Standard Deviation|Mean
1416271|NCT01128296|Secondary|Disease-free Survival (DFS) by CA 19-9 Response|Median number of months of disease-free survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from >0 to 225%. Per participant decreases in Ca 19-9 ranged from >0 to 100%.|Up to 30 months|Analysis population included a total of 26 participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response.|||months||95% Confidence Interval|Median
1416272|NCT01128296|Secondary|R0 Resection Rate|Number of participants that underwent a resection with microscopically margin-negative resection in which no gross or microscopic tumor remains in the primary tumor bed (24) / number of that completed treatment (31)|Up to 30 months|Participants that completed more than 80 % of the intended dose of HCQ.|||percentage of participants|||Number
1416273|NCT01128296|Secondary|Overall Survival (OS) by Response to HCQ Treatment|Median number of months of overall survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ.|Up to 35 months|Subset of participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
1416274|NCT01128296|Secondary|Disease-free Survival (DFS) by Response to HCQ Treatment|Median number of months of disease-free survival in participants who did and did not experience response to HCQ treatment. Patients who had >51 % increase in their LC3-II staining were classified as having a response to HCQ.|Up to 30 months|Subset of participants that completed more than 80% of the intended dose of HCQ treatment.|||months||95% Confidence Interval|Median
1416275|NCT01128296|Secondary|Overall Survival (OS)|Median number of months of overall survival for participants receiving study treatment.|Up to 35 months|Participants that completed more than 80% of the intended dose of HCQ.|||months||95% Confidence Interval|Median
1416276|NCT01128296|Secondary|Disease-free Survival (DFS)|Median number of months of disease-free survival for participants receiving study treatment.|Up to 30 months|Participants that completed more than 80 % of the intended dose of HCQ.|||months||95% Confidence Interval|Median
1416277|NCT01128296|Primary|Number of Participants That Experienced a Dose Limiting Toxicity (DLT)|Number of Participants at each dose level of HCQ that experienced a Dose Limiting Toxicity (DLT).|Up to 31 days|Observed for dose-limiting toxicities or treatment delays attributed to HCQ to determine the maximum tolerated dose.|||participants|||Number
1416278|NCT01128270|Secondary|Detectable DCA After Day 1 in Serum (0=No 1=Yes)|All four arms receive Chloral Hydrate on Day 1 (arms 1A and 1B environmental levels) and (arms 2A and 2B therapeutic levels). The question is could Dichloroacetate be detected in serum at the end of day 1. This analysis is purely descriptive, and no comparisons were planned.|1 day|All eligible session completers|||participants|||Number
1416279|NCT01128270|Primary|Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)|The levels were clinically indetectable at baseline and the question was whether or not substantive levels would be noted at after 5 days exposure to Chloral Hydrate. Detectable, but low levels were detected.|5 days|all eligible participants to arm 2B (Period 4)|||micrograms per ml clorohydrate||Standard Deviation|Mean
1416280|NCT01128270|Primary|Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate|Elimination Half-life Difference on Arm 2B for 13C-Labeled trichloroacetate between day 5 (prolonged exposure) and day 1 (de novo exposure) after therapeutic level exposure to Chloral Hydrate. This outcome only applies to Period 4. Trichloroacetate is a marker, not an intervention.|5 days|This applies only to Arm 2B (Therapeutic Chloral Hydrate without DCA.|||minutes||Standard Deviation|Mean
1416281|NCT01128270|Primary|Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.|After 5 days of of therapeutic level Chloral Hydrate, the levels of Dichloroacetate in the plasma were measured.|6 Days||||micrograms/ml||Standard Deviation|Mean
1416282|NCT01128244|Secondary|Plasma 3-hydroxykynurenine Concentration|For all subjects, analysis of blood samples before and after vitamin B6 supplementation will allow evaluation of discriminating biomarkers using targeted metabolite profile analysis of one-carbon metabolism and tryptophan catabolism constituents. Also, we will conduct exploratory evaluation and potential identification of new biomarkers using metabolomics analysis on subjects before and after vitamin B6 supplementation.|April, 2010 - June, 2014|Women using oral contraceptives and exhibiting low vitamin B6 status.|||microl/L||Standard Deviation|Mean
1416283|NCT01128244|Primary|Fasting Plasma Cystathionine Concentration|For all subjects, the concentration of plasma cystathionine in fasting blood samples taken before and after the supplementation period will provide a functional measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.|||micromol/L||Standard Deviation|Mean
1416284|NCT01128244|Primary|Fasting Plasma Pyridoxal Phosphate Concentration|For all subjects, the concentration of plasma pyridoxal phosphate in fasting blood samples taken before and after the supplementation period will provide a direct measure of vitamin B6 nutritional status.|Fasting blood samples will be taken at baseline and after 28 days of vitamin B6 supplementation.|Women using oral contraceptives and exhibiting low vitamin B6 status.|||nmol/L||Standard Deviation|Mean
1416285|NCT01128244|Primary|Flux of Homocysteine Remethylation From Serine-derived Carbon|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of homocysteine remethylation from serine-derived carbon before and after vitamin B6 supplementation. These flux values may be slightly higher than flux of total homocysteine remethylation in Outcome Measure 1 because of the small contribution of methionine salvage to the flux measured in Outcome Measure 2.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives and exhibiting low vitamin B6 status.|||micromol/(kg x hr)||Standard Deviation|Mean
1416286|NCT01128244|Primary|Total Remethylation of Homocysteine|Data from analysis of serine, methionine and leucine in the timed blood samples of all subjects will provide a measurement of the metabolic rate of total remethylation of homocysteine before and after vitamin B6 supplementation.|Blood samples will be taken prior to infusion and at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7.5, and 9h. Infusions will be conducted at baseline and after 28 days|Women using oral contraceptives exhibiting low vitamin B6 status evaluated at baseline and after vitamin B6 supplementation.|||micromol/(kg x hr)||Standard Deviation|Mean
1416292|NCT01128192|Primary|Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp|Blood samples were taken at -30 min, -15 min, 0 min, 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min to assess the plasma insulin levels during Hyperglycemic Clamp (2-step hyperglycemic clamp test with arginine stimulation). The mean change in plasma insulin levels from Day 2 to Day 9 were calculated as Values on Day 9 - Values on Day 2.|0-10 mins, 10-180 mins, 0-180 mins (Day 2 and Day 9)||||h*pmol/L||Standard Deviation|Mean
1416293|NCT01128192|Primary|Change in Insulin Basal Level|Change from Day 2 and Day 9 of insulin basal levels (2-step hyperglycemic clamp test with arginine stimulation)|-30 min and -15 min on Day 2 and Day 9||||pmol/L||Standard Deviation|Mean
1416294|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma insulin level. The mean change in plasma insulin level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)||||h*pmol/L||Standard Deviation|Mean
1416295|NCT01128192|Secondary|Change Fasting Plasma Insulin Level|An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at -30 min to assess the fasting plasma insulin level. The mean change in fasting plasma insulin level from Day 1 to Day 8 was assessed.|-30 minutes on Day 1 and -30 minutes on Day 8||||pmol/L||Standard Deviation|Mean
1416296|NCT01128192|Secondary|Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)|Blood samples were taken at -30 min, 0 min, 30 min, 60 min, 90 min, 120 min, 150 min, 180 min to assess the plasma glucose level. The mean change in plasma glucose level from Day 1 to Day 8 were calculated as Values on Day 8 - Values on Day 1.|0-30 mins, 30-180 mins, 0-180 mins (Day 1 and Day 8)||||h*mmol/L||Standard Deviation|Mean
1416297|NCT01128192|Secondary|Change in Fasting Plasma Glucose Level|"An Oral Glucose Tolerance Test was performed at Day 1 (baseline) and Day 8 (post-treatment). Samples were taken at~-30 min to assess the fasting plasma glucose level. The mean change in fasting plasma glucose level from Day 1 to Day 8 was assessed."|-30 minutes on Day 1 and -30 minutes on Day 8||||mmol/L||Standard Deviation|Mean
1416298|NCT01128179|Secondary|Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)||12 weeks|PP|||mmol^2/L^2||Standard Error|Least Squares Mean
1416299|NCT01128179|Secondary|Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)||12 weeks|PP|||mmol/L||Standard Error|Least Squares Mean
1416300|NCT01128179|Secondary|Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)||12 weeks|PP|||mmol/L||Standard Error|Least Squares Mean
1416301|NCT01128179|Secondary|Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)||12 weeks|PP|||percentage of excretion of phosphate||Standard Error|Least Squares Mean
1416302|NCT01128179|Secondary|Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)||12 weeks|PP|||pg/ml||Standard Error|Least Squares Mean
1416303|NCT01128179|Secondary|Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)||12 Weeks|PP|||pg/ml||Standard Error|Least Squares Mean
1416304|NCT01128179|Primary|Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)|FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.|12 Weeks|Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable.|||pg/ml||Standard Error|Least Squares Mean
1416305|NCT01128153|Secondary|Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)|Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||Participants|||Number
1416306|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mmol/L||95% Confidence Interval|Mean
1416307|NCT01128153|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mg/dL||95% Confidence Interval|Mean
1416308|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mmol/L||95% Confidence Interval|Mean
1416309|NCT01128153|Secondary|Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]|Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||mg/dL||95% Confidence Interval|Mean
1416310|NCT01128153|Primary|Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)|Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model|From Baseline to Week 24 weeks|Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.|||percent||95% Confidence Interval|Mean
1416311|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score|The CGI-S is scored to rate patient’s current clinical state. At enrolment patient’s condition is rated using the CGI-S. At assignment CGI-S is again completed and a score of at least 4 (moderately ill). The score at assignment Day 1 will be regarded as the baseline value. At all following visits CGI-S will be rated. Each CGI item is scored on a scale from 1 to 7. A CGI-S score of 1 indicates that a patient is “Normal, not at all ill” and a score of 7 indicates that a patient is “Among the most extremely ill patients”.|Baseline, week 4|||||||
1416312|NCT01128114|Secondary|The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4|The Global Improvement scale (CGI-I) is scored to rate the patient’s change from baseline CGI. A CGI-I score of 1 indicates that a patient is “very much improved” and a score of 7 indicates that a patient is “very much worse.” CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement. At all following visits CGI-I will also be rated. The following calculations will be made: Proportion of patients with CGI Global Improvement rating ≤ 2 at Day 29|Baseline, week 4|||||||
1416313|NCT01128114|Secondary|The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score|The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure severity of manic episodes. There are 4 items graded on a 0 to 8 scale (irritability, speech, thought content, disruptive/aggressive behavior), and 7 items graded on 0 to 4 scale. These 4 items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Typical YMRS baseline scores can vary a lot. They depend on patients’ clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2.|Baseline, week 4|||||||
1416314|NCT01128114|Primary|The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)|CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.|Baseline, week 4|As the study was terminated prematurely none of the randomized patients have been analysed.|||Participants|||Number
1416315|NCT01128049|Primary|Visual Quality|Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.|5 seconds|The comparison was between normal, non-dry eye participants and dry eye groups.|||microns||Standard Deviation|Mean
1416316|NCT01127763|Primary|Toxicity Profile-Non Hematological|Reported as percentage of patients who experienced grade 3 and higher non-hematological AEs related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.|||percentage of patients|||Number
1416317|NCT01127763|Secondary|Median Progression-free Survival Time|Progression-free survival time is defined as the time from first day of treatment to the first date of disease progression or death as a result of any cause. Progression was assessed every 2 cycles of treatment (6 weeks) by CT, CT/PET, or MRI. Progression is defined using RECIST 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|up to 1 year|Any patient with at least one dose of treatment.|||months||95% Confidence Interval|Median
1416318|NCT01127763|Primary|Toxicity Profile-Hematological|Reported as percentage of patients who experienced grade 3 and higher hematological adverse events (AEs) related to the study drugs.|treatment period (up to 1 year) plus 30 days off treatment|any patient who received at least 1 dose of protocol treatment.|||percentage of patients|||Number
1416319|NCT01127763|Primary|Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease That Lasts More Than 6 Months)|Clinical benefit rate is defined as the number of patients with complete response (CR), partial response (PR), or stable disease (SD) that lasts at least 6 months. Response was assessed every 2 cycles of treatment (6 weeks) by computed tomography (CT), CT/positron emission tomography (PET), or magnetic resonance imaging (MRI). Overall response evaluation is based on Response Evaluation Criteria In Solid Tumors 1.0 (RECIST 1.0). Per RECIST 1.0 for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 1 year|Any patient with at least one dose of treatment.|||percentage of patients||95% Confidence Interval|Number
1416320|NCT01127737|Primary|Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention|The number of control and intervention participants who checked their skin for cancer within the 1 month after the study visit.|1 month|Per protocol|||Participants|||Number
1416321|NCT01127659|Secondary|Inflammation||6 months|||||||
1416322|NCT01127659|Secondary|Body Composition||6 months|||||||
1416323|NCT01127659|Primary|Insulin Sensitivity|measured by HE clamps (baseline and 6 mths)|6 months|Glucose infusion rate in HE clamps was measured|||mg/kg fat free mass/min||Standard Deviation|Mean
1416324|NCT01127646|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
1416325|NCT01127646|Other Pre-specified|Change From Baseline in Heart Rate up to 5 Weeks||Baseline, up to 5 weeks|Safety population: all participants who entered the study and took at least 1 dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
1416479|NCT01126541|Secondary|Cortisone Intake AUC (Time- and Weight-Weighted)|All cortisone intakes (in mg) were taken into account (oral, IV [including the cortisone administration before the rituximab infusion], intramuscular, and intra-articular).|Day 1 (each infusion), Week 24, Week 104|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mg*week||Standard Error|Mean
1416326|NCT01127646|Secondary|Global Impression of Perceived Difficulties Investigator Version (GIPD-Inv) Total Score and Subscores At Weeks 2, 3, and 4|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, and over entire day and night). Difficulties during past week are rated by investigator on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items) and ranges from 5 to 35. Higher scores indicate greater impairment. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416327|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score During the 4-Week Treatment Period|The teacher version of Conners' Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conners’ Global Index-Teacher Rating Scale total score for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416328|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Total Score and Subscores During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 3 common morning behaviors (such as, get out of bed) and 8 common evening behaviors (such as, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. Mean DPREMB-R total score and subscores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416329|NCT01127646|Secondary|Patient Outcomes Questions (On-Days Versus Off-Days) During the 4-Week Treatment Period|"6-item questionnaire from attention-deficit/hyperactivity disorder (ADHD) advocacy group evaluates treatment outcomes ADHD participant's perspective. Parent completed on each day of on/off period. Each item ranged from 1 (I totally agree) to 5 (I totally disagree). Items 1 and 2 pertain to sleeping and eating; high scores=better outcome. Items 3-6 pertain to behavior; high scores=worse outcome. The mean scores for analysis would have been created for each question across the days of each of the on and off phases; however, mean scores were not analyzed due to insufficient sample size."|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416330|NCT01127646|Secondary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Subscores (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Evening behavior total score range is 0 to 24. Morning behavior total score range is 0 to 9. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R subscores between days without missing doses (on-days) and days with missing doses (off-days) not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416331|NCT01127646|Secondary|Emotion Expression Scale for Children (EESC)-Parent Rated Total Score up to Week 5|"29-item parent-reported measure used to monitor effect of attention-deficit/hyperactivity disorder (ADHD) medication; examines 3 aspects of emotion expression: positive emotions, emotional flatness, and emotional lability. Each item rated on 5-point Likert scale (1=not at all true to 5=very much true). Positive emotional subscale items reversed scored (6-raw score). Total score=transformed positive emotion + emotional flatness+ emotional lability subscales. Total scores range: 29 to 145. Higher scores=emotional impairment. This outcome measure not analyzed due to insufficient sample size."|Up to Week 5|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416332|NCT01127646|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) at Weeks 2, 3, and 4|This instrument is a single-item expert rating of the severity of the participant’s attention-deficit/hyperactivity disorder (ADHD) symptoms in relation to the assessor’s total experience of participants with ADHD. Severity is rated on a 7-point scale (1=normal, not ill at all; 7=among the most extremely ill participants). Higher scores represent greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416333|NCT01127646|Secondary|Attention-Deficit/Hyperactivity Disorder Rating Scale-Parent Version: Investigator Administered and Scored (ADHD-RS-IV Parent:Inv) Total Score and Subscores at Weeks 2, 3, and 4|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. This outcome measure was not analyzed due to the insufficient sample size.|Weeks 2, 3, and 4|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416334|NCT01127646|Secondary|Global Impression of Perceived Difficulties Scale-Patient Version (GIPD-Pat) Scale Total Score and Individual Items During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Difficulties during past week are rated by participant on a 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. Mean GIPD-Pat total score and individual item scores for days with missing doses (off-days) between both groups were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416533|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416335|NCT01127646|Secondary|Conners' Global Index-Teacher Rating Scale Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|The teacher version of Conners’ Global Index consists of 10 items with each item being scored on a 4-point scale ranging from 0 (not true at all, or never/seldom) to 3 (very much true, or very often/very frequent). The total score ranges from 0 to 30. Higher scores indicate greater impairment. The Conner’s Global Index-Teacher Rating Scale total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416336|NCT01127646|Secondary|Global Impression of Perceived Difficulties (GIPD) Scale-Patient Version Total Score and Individual Items (On-Days Versus Off-Days) During the 4-Week Treatment Period|Assesses attention-deficit/hyperactivity disorder (ADHD)-related difficulties (overall difficulties perceived in morning, during school, during homework, in evening, over entire day and night). Participant rates difficulties during past week on 7-point scale (1=normal, not difficult at all; 7=extremely difficult) for each of 5 items. Total score=sum of all subscores (items); range: 5 to 35. Higher scores=greater impairment. GIPD-Pat total score and item scores between days without missing doses (on-days) and days with missing doses (off-days) were not analyzed due to insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416337|NCT01127646|Primary|Daily Parent Report of Evening and Morning Behavior-Revised (DPREMB-R) Scale Mean Total Score (On-Days Versus Off-Days) During the 4-Week Treatment Period|Parent-completed 11-item questionnaire; measures difficulty level of and 8 common evening behaviors (such as, sit through dinner) and 3 common morning behaviors (such as, get out of bed). Each item is scored on a 4-point Likert scale ranging from 0 (no difficulty) to 3 (a lot of difficulty). Total score (evening+morning) range is 0 to 33. Higher scores indicate greater difficulty in evening and morning behavior. DPREMB-R total score between days without missing doses (on-days) and days with missing doses (off-days) was not analyzed due to the insufficient sample size.|Baseline through 4 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.||||||
1416338|NCT01127633|Secondary|Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer’s Disease|Florbetapir PET imaging was used to test for change from baseline. The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum and to subject-specific white matter.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants with mild Alzheimer's Disease from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for Amyloid Plaque Burden.|||Standard Uptake Value ratio (SUVr)||Standard Deviation|Mean
1416339|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)|The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADAS-Cog11.|||units on a scale||Standard Error|Least Squares Mean
1416340|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)|The vMRI assessment of right and left hippocampal volume is reported. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for vMRI.|||Cubic millimeter (mm³)||Standard Error|Least Squares Mean
1416341|NCT01127633|Secondary|Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels|Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay. The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 52|All Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for plasma Aβ 1-40 and Aβ 1-42.|||picograms per milliliter (pg/mL)||Standard Error|Least Squares Mean
1416342|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)|The MMSE is an instrument used to assess a participant's cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment). The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment). The range for MMSE Total Score is 0 to 30. Lower scores indicate more impairment. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for MMSE.|||Units on a scale||Standard Error|Least Squares Mean
1416553|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416343|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)|The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant. The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent). QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52. Higher scores denote a better quality of life. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for QoL-AD.|||Units on a scale||Standard Error|Least Squares Mean
1416344|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)|EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state. Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems). These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm. EQ-5D US Population-Based Index Scores range from -0.11 to 1.0. A score of 1.0 indicated perfect health. The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state). LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for EQ-5D Proxy.|||Units on a scale||Standard Error|Least Squares Mean
1416345|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours|The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver. It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision. Scores range from 0 to 24 hours. Higher values indicate greater resource use. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for RUD-Lite.|||hours per day (hr/day)||Standard Error|Least Squares Mean
1416346|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)|The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144. Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for NPI.|||Units on a scale||Standard Error|Least Squares Mean
1416347|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)|CDR-SB is a semi-structured interview of participants and their caregivers. Participant’s cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for CDR-SB.|||Units on a scale||Standard Error|Least Squares Mean
1416348|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)|ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant’s caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADCS-ADL.|||Units on a scale||Standard Error|Least Squares Mean
1416368|NCT01127607|Secondary|Parenting Locus of Control (PLC)|"self completed parenting measure of the degree to which parents feel they can influence their child’s behavior. Measure consists of 25 items each rated using a Likert scales that ranges from 1 (strongly disagree) to 5 (strongly agree). Range is 25 to 125 with higher scores indicating greater parental control over their child's behavior (desired outcome). At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416349|NCT01127633|Secondary|Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.|Baseline, Week 104|Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline & at least one post baseline observation for ADAS-Cog14.|||Units on a scale||Standard Error|Least Squares Mean
1416350|NCT01127633|Primary|Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)|The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 104|All randomized participants who received at least one dose of study drug.|||participants|||Number
1416351|NCT01127607|Secondary|Adult ADHD Rating Scale Completed at the End of the Med Optimization Phase|Measures change in all DSM IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. All information obtained during clinician interview of patient. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items (sum of two subscales) rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms.|baseline and end of med optimization phase/week 4|Uses a within-subjects design; the same 27 participants are in both arms.|||scores on a scale||Standard Deviation|Mean
1416352|NCT01127607|Secondary|Pittsburgh Side Effects Rating Scale - Percent Present for All Reported Adverse Events Occurring at a Rate of 5% or More|Self report of side effects measured during dose titration using the Pittsburgh Side Effects Rating Scale. Consists of 13 items each rated using 0(none) to 3 (severe) scales. Items endorsed as 1 (mild) or above were counted as present. Information on additional adverse events not part of the PSERS was collected by direct interview of the participants. All side effects occurring at a frequency of 5% or more are reported. Initial side effect data is reported for all participants entering pre-randomization med optimization phase who took medication (n=36) vs those formally enrolled (N=27). Also, side effect data for the med titration phase is entered per dose rather than per participant. For example, a person trying the 30, 50 and 70mg dose is entered is entered 4 times (no med as well) vs. just once. This is why baseline N is higher than for other outcomes collected at weeks 4 and 8 where data was only available for those completing the pre-randomization med optimization phase (N=27).|end of medication optimization phase/week 4|Within-subjects analysis; data entered per dose not per subject. For example, if subject 1 took 30mg, 50mg and 70mgdoses during titration, they are recorded as three separate entries. Sample size reduces as dose increases because participants stopped at lowest acceptable dose and only moved to higher dose if they did not meet optimization criteria.|||Percent of participants|||Number
1416353|NCT01127607|Secondary|Resting Pulse|measured at last assessment visit when at rest using an automated blood pressure machine; results reported in beats per minute. At endpoint, the medication group (N=8) was compared to the placebo group (N=9).|study endpoint- end of period II (between subjects trial)||||bpm||Standard Deviation|Mean
1416354|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed.Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.|||Percentage of behaviors||Standard Deviation|Mean
1416355|NCT01127607|Primary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Counts|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors. Average number of behaviors per group were computed. Three subjects dropped prior to completing this assessment and one participant completed the other endpoint measures but not the DPICS, which is why the total N for this outcome is 23 at study endpoint. At end of period II (study endpoint), the medication group (n=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)|Task situation (homework vs. non-academic) was within-subjects; all participants completed both types of interactions. Medication was between subjects.|||behaviors||Standard Deviation|Mean
1416356|NCT01127607|Secondary|Weight|Weight measured on calibrated scale; participant measured without shoes or heavy clothing (jackets, sweaters, etc...). reported in kilograms.At endpoint, the medication group (N=9) was compared to the placebo group (N=11).|study endpoint- end of period II (between subjects trial)||||kg||Standard Deviation|Mean
1416369|NCT01127607|Secondary|Parenting Stress Index (PSI)--Total Stress|measures change in stress of parent child interactions and completed by the participant. The PSI is a measure of the source and degree of parenting stress (Abidin, 1995), which contains 120 items which are rated on a 1 (strongly disagree) to 5 (strongly agree) scale. 101 of these items are used to compute a total stress score (reported below) as the other 19 report on specific life stressors. Range is 101 to 505, for which higher scores indicate higher levels of stress. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416357|NCT01127607|Secondary|Impairment Rating Scale (IRS)|self rated measure of global impairment of adult participants derived from the child IRS. The IRS-A assesses impairment overall and in specific domains, including interpersonal relationships, academic performance, and self-esteem, and includes adult-specific domains of functioning, such as employment and romantic relationships. The IRS-A assesses current problems and need for treatment. Each subscale is rated from 0 (no problem) to 6 (extreme problem).At endpoint, the medication group (N=11) was compared to the placebo group (N=13). Overall Impairment is its own subscale and not a composite score of the others.|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416358|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.~At endpoint, the medication group (N=9) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416359|NCT01127607|Secondary|Resting Blood Pressure|Measured at rest at last assessment visit using an automated blood pressure machine; results reported in mmHG. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)||||mm Hg||Standard Deviation|Mean
1416360|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale Mean Severity Rating.|rates 13 potential adverse events of Central Nervous System (CNS) stimulants on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants. Mean severity rating then averaged across 13 categories.At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416361|NCT01127607|Secondary|Barkley Home Situations Questionnaire (HSQ)|Self completed by adult participants. Measures their child's functioning in the evening by asking them to report whether or not their child had problems in developmentally important areas. Number of problems per child are counted and counts are then averaged for each group with higher numbers representing more problems. At endpoint, the medication group (N=9) was compared to the placebo group (N=10).|study endpoint- end of period II (between subjects trial)||||number of child problems endorsed||Standard Deviation|Mean
1416362|NCT01127607|Secondary|ADHD Severity Clinical Global Impressions Severity Subscale|clinician rated measure of ADHD symptom severity in adult participants. The severity subscale is scored from 1 (normal) to 7 (extremely ill).At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416363|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability. At endpoint, the medication group (N=9) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416364|NCT01127607|Secondary|Impairment Rating Scale (IRS)|measures global functioning of child rated by the parent who was the participant in the study. The IRS is a 7 item measure that uses visual-analogue scales to evaluate the child’s problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance. Each subscale including overall severity is scored from 0 (no problem) to 6 (extreme problem) with higher scores indicating more impairment. At endpoint, the medication group (N=10) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416365|NCT01127607|Secondary|Disruptive Behavior Disorder Rating Scale (DBD)|measures externalizing symptoms in children.measures externalizing symptoms in children completed by their primary caretaker who was a participant in the study. The DBD (Pelham et al., 1992) assessed DSM symptoms of ADHD, ODD, and CD from 0 (not at all) to 3 (very much). The DBD includes symptoms of DSM-III and DSM-IV ADHD, Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD).At endpoint, the medication group (N=10) was compared to the placebo group (N=12).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416366|NCT01127607|Secondary|Social Skills Rating System (SSRS)|"Measures child's interactions with peers and adults. Items rated using Likert scales that range from 0 (never) to 2 (often).At week 8, the medication group (N=10) was compared to the placebo group (N=11). There are two subscales: Problem Behaviors (18 items rated between 0-2 for total score range of 0 to 36) and Social Skills (40 items rated 0-2 with range for total score of 0-80). The total scores for these scales are reported as standard scores, with a population mean of 100 and standard deviation of 15. For problem behavior higher scores indicate worse behavior whereas for social skills, higher scores indicate more social (or better behavior)."|study endpoint- end of period II (between subjects trial)||||standard scores||Standard Deviation|Mean
1416367|NCT01127607|Secondary|Brown Attention Deficit Scale (BAADS)|"Measures executive functioning using 40 items each rated using a Likert Scale that ranges from 0 (never) to 3 (almost daily). Activation, Attention and effort subscales are 9 items each with range of 0-27. Affect scale is 7 items (range 0-21), memory is 6 items (range 0-18) and total score is 40 items (range 0-120). All raw scores are then reported as T scores based on normative data with higher T scores indicating worse executive functioning. At endpoint, the medication group (N=10) was compared to the placebo group (N=13)."|study endpoint- end of period II (between subjects trial)||||t score||Standard Deviation|Mean
1416379|NCT01127581|Secondary|Incidence of Vaginal Delivery||Interval from study drug administration to vaginal delivery (average 24 hours)|The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
1416370|NCT01127607|Secondary|Adult ADHD Rating Scale (ADHD RS)|measures change in all DSM (Diagnostic and Statistics Manual) IV ADHD symptoms on a 0 (least severe) to 3 (most severe) scale. Inattention and hyperactive/impulsive subscales each consist of 9 items with range of 0 to 27. Total Score consists of all 18 items rated 0 to 3 with range of 0 to 54. For all, higher scores indicate more symptoms. All information obtained during clinician interview of patient. At endpoint, the medication group (N=11) was compared to the placebo group (N=13).|study endpoint- end of period II (between subjects trial)||||units on a scale||Standard Deviation|Mean
1416371|NCT01127607|Secondary|Pittsburgh Side Effect Rating Scale|rates 13 potential adverse events of central nervous system stimulant medications on a 0-3 likert scale with 0=none 1=mild severity, 2=moderate severity, 3=severe severity. Form completed by participants at end of med optimization phase. Mean severity rating then averaged across 13 categories. This compares mean side effect severity at unmedicated baseline state vs. on optimal dose at week 3. Analysis includes all participants completing medication optimization.|baseline and end of dose optimization phase/week 4|Within-subjects analysis; same 26 participants are in the unmedicated and optimal dose of medication arms.|||units on a scale||Standard Deviation|Mean
1416372|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS) - Behavior Percentages|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Percentages of behaviors as a function of total verbalizations (for praise, negative talk, demanding) or as a function of commands and questions (for impatient and responsive) were computed. This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design; the same 26 participants completed all arms.|||Percentage of behaviors||Standard Deviation|Mean
1416373|NCT01127607|Secondary|Dyadic Parent-Child Interaction Coding System (DPICS)|Observations of parents and children as they interact with each other during a five minute homework task and during a 10 minute non-academic task. Interactions were recorded and later coded by trained observers. Observers counted number of parent and child behaviors with each parent-child dyad counted as one participant. Average number of behaviors per group were computed.This outcome was part of period I- the within subject comparison of all participating subjects once on placebo (n=26) and once with all subjects on active medication (N=26). (the 27th participant completed this phase but partial data was lost due to mechanical failure with video equipment so their data was not included). All adult participants received both placebo and active medication in this phase that comprised all of period 1.|weeks 4 and weeks 5 (period I within subjects trial)|Used a within-subjects design for this phase; the same 26 participants completed all four arms.|||behaviors||Standard Deviation|Mean
1416374|NCT01127607|Secondary|Sheehan Disability Scale (SDS)|The SDS consists of 3 self rated items assessing the degree to which symptoms affect work/school, social life, and family/home responsibilities. Items are rated on a 0 (not at all) to 10 (extremely) scale. Items were averaged into an overall disability score with range of 0 to 10 with higher scores indicating more severe disability.Within subject comparison of no medication baseline vs. optimal dose medication.|baseline and week 4|Uses a within-subjects design; the same 25 participants are in both arms.|||units on a 0 to 10 scale||Standard Deviation|Mean
1416375|NCT01127607|Secondary|Impairment Rating Scale (IRS)|"Parent ratings of their child's functioning and need for treatment in developmentally important domains. Ratings are completed using visual-analogue scales that are anchored at the low end by no problems / no need for treatment and at the high end by extreme problem / definitely needs treatment. Visual analogue ratings for each subscale were converted to 0 to 6 scales with higher values indicating greater impairment and lower values indicating less impairment for each subscale.Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Uses a within-subjects evaluation; the same 25 participants are in both arms.|||units on a 0 to 6 scale||Standard Deviation|Mean
1416376|NCT01127607|Secondary|Disruptive Behavior Disorders Rating Scale (DBD)|Parent ratings of their child's symptoms of attention-deficit hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), and conduct disorder (CD). Measure consists of 45 items each rated on a Likert scale that ranges from 0 (not at all) to 3 (very much). Items are averaged to form adhd-inattention, adhd-hyperactive/impulsive, ODD, and CD scores.Within subject comparison of no medication baseline vs. optimal dose medication. ADHD subscale consists of 20 items with range of 0 to 60. ODD subscale consists of 9 items with range of 0 to 27. CD subscale consists of 15 items with range of 0 to 45. For all subscales, higher scores indicate more severe symptoms.|baseline and week 4|Used a within-subjects design; the same 24 participants measured in both arms.|||units on a scale||Standard Deviation|Mean
1416377|NCT01127607|Secondary|Alabama Parenting Questionnaire (APQ)|"measures change in parenting practices.The APQ is a 42-item measure (each item ranges from 1/always to 5/never) on which parents are asked to indicate the frequency with which they implement the following parenting practices: involvement (10 items range 10-50- higher scores mean more parental involvement), positive parenting (6 items with range of 6 to 30 and higher scores indicate greater use of praise), poor monitoring/supervision (10 items with range of 10 to 50 and higher scores indicate less supervision/monitoring), inconsistent discipline(6 items with range of 6 to 30 and higher scores indicate greater problems with inconsistent discipline), and corporal punishment (3 items with range of 3-15 and greater scores indicate more use of corporal punishment). Items are rated on a 5-point scale, ranging from 1 (“never”) to 5 (“always”). Items summed into composite scales.~Within subject comparison of no medication baseline vs. optimal dose medication."|baseline and week 4|Used a within-subjects evaluation; the same 24 participants evaluated in both arms.|||units on a scale||Standard Deviation|Mean
1416378|NCT01127581|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.|From study drug administration to hospital discharge (approximately 48-72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.|||percentage of participants|||Number
1416385|NCT01127581|Secondary|Time to Active Labor During the First Hospital Admission|Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.|Interval from study drug administration to active labor (average 12 hours)|Intention-to-Treat (ITT) population|||minutes||95% Confidence Interval|Median
1416386|NCT01127581|Secondary|Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission||Interval from study drug administration to neonate delivery (average 24 hours)|Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge.|||minutes||95% Confidence Interval|Median
1416387|NCT01127581|Primary|Incidence of Cesarean Delivery During the First Hospital Admission||Interval from study drug administration to cesarean delivery (average 24 hours)|Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event.|||percentage of participants||95% Confidence Interval|Number
1416388|NCT01127581|Primary|Time to Vaginal Delivery During the First Hospital Admission||Interval from study drug administration to vaginal delivery (average 24 hours)|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored.|||minutes||95% Confidence Interval|Median
1416389|NCT01127503|Secondary|To Evaluate the Efficacy of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS||13 weeks|||||||
1416390|NCT01127503|Primary|To Evaluate the Safety of Metyrosine (Demser®) for the Treatment of Psychosis in Patients With VCFS||13 weeks|The study was terminated early and no data was collected||||||
1416391|NCT01127438|Secondary|Number of Participants With Modified Sedation Success|Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.|Day 1|Full Analysis Population.|||Participants|||Number
1416392|NCT01127438|Secondary|Number of Participants With Treatment Success|Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.|Day 1|Full Analysis Population.|||Participants|||Number
1416393|NCT01127438|Primary|Number of Participants With Sedation Success|Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject’s level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.|Day 1|Full Analysis Population: All treated subjects who received study drug and had at least one postdose efficacy measurement.|||Participants|||Number
1416394|NCT01127321|Secondary|Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit||Predose on Day 1; Day 85, 113, and 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.|||participants|||Number
1416395|NCT01127321|Secondary|Pharmacokinetic Parameters for MEDI-570|Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169|Due to early termination of the study, the results were reported as individual participant’s listings but not statistically summarized.||||||
1416396|NCT01127321|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 to Day 169|Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.|||participants|||Number
1416397|NCT01127256|Secondary|Quality of Life in Epilepsy (QoL-QOLIE31)|Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.|24 weeks||||Units On a Scale||Standard Deviation|Mean
1416398|NCT01127256|Secondary|The Percentage of Participants With Retention Rate|The percentage of participants who completed the trial.|24 weeks||||percentage of participants|||Number
1416399|NCT01127256|Primary|The Percentage of Participants With Seizure Free Rate|The percentage of participants who had no seizure during the trial.|24 weeks||||percentage of participants|||Number
1416554|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416401|NCT01127165|Secondary|Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)|The difference of K-CBCL between before and after the administration. K-CBCL is the Korean version of CBCL which is a standardized form that parents fill out to describe their children’s behavioral and emotional problems. The total score ranges 0- 234, with higher scores indicating worse behavioral and emotional problems.|Baseline and 24 weeks||||Scores on a Scale||Standard Deviation|Mean
1416402|NCT01127165|Secondary|Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)|Cognitive assessment was performed using K-WISC-III. The total score of K-WISC-III is calculated as Full Scale IQ which ranges from 31 (worst) to 151(best). Higher scores indicate greater intelligence, lower scores indicate less intelligence. Thus a positive change indicated an improvement.|Baseline and 24 weeks||||Scores on a Scale||Standard Deviation|Mean
1416403|NCT01127165|Primary|Percentage of Participants Who Were Assessed As Seizure Free|The percentage of participants who showed no seizure during the maintenance phase.|24 weeks||||percentage of participants|||Number
1416404|NCT01127139|Secondary|Adverse Events Leading to Study Discontinuation|The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.|Baseline to Month 6 Visit|All participants with case report forms were included in this analysis.|||Participants|||Number
1416405|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 6 Visit|This analysis included all participants with complete data for the entire study.|||Participants|||Number
1416406|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed since their previous visit.|Month 6 Visit|All participants with evaluable case report forms were analyzed.|||participants|||Number
1416407|NCT01127139|Secondary|Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal|The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.|Month 3 Visit|This analysis included all participants with complete data for the entire study.|||Participants|||Number
1416408|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.|Month 6 Visit|This analysis included all participants with complete data for the entire study.|||Percentage of participants|||Number
1416409|NCT01127139|Secondary|Percentage of Patients Achieving Blood Pressure < 140/90 mmHg|The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.|Month 3 Visit|This analysis included all participants with complete data for the entire study.|||Percentage of participants|||Number
1416410|NCT01127139|Secondary|Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.|Baseline to Month 6 Visit|This analysis included all participants with complete data for the entire study.|||mmHg||Standard Deviation|Mean
1416411|NCT01127139|Primary|Compliance With Tarka Treatment, All Participants and by Gender.|Participants were asked how many doses of Tarka they had missed after three months of treatment.|Month 3 Visit|All participants with evaluable case report forms were analyzed.|||participants|||Number
1416412|NCT01127087|Secondary|Total Urinary Oxalate Excretion|Oxalate is a salt of oxalic acid produced by the body's metabolism and excreted in the urine, measured in this study in two, 24-hour, urine collections.|Baseline, 4 weeks||||mg/24 hrs||Standard Deviation|Mean
1416413|NCT01127087|Primary|Urinary Oxalate Creatinine Ratio|The urinary oxalate per creatinine ratio is expressed as mg/g. Paired t-test will be used when comparing reduction of urinary oxalate resulting from treatment (versus baseline) for each subject group.|Baseline, Week 4||||mg/g||Standard Deviation|Mean
1416414|NCT01126957|Secondary|Satisfaction With Procedural Sedation|Score of 1 to 5 with 5 being completely satisfied and 1 being not satisfied at all was recorded by both the monitoring nurse and the physician performing the procedural sedation|20 minutes|103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.||||||
1416415|NCT01126957|Primary|Respiratory Depression|"Endotracheal carbon dioxide (ETCO2) rise > 5mm/hg~Arterial oxygen saturation (SaO2) <90%~Respiratory rate (RR) < 8 br/min~Apnea > 15 sec~airway manipulation"|Baseline and throughout procedure|103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.||||||
1416416|NCT01126801|Secondary|Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.||one month|No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.||||||
1416417|NCT01126801|Primary|Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.||one month|No participants were analyzed since the study was terminated due to difficulty recruiting subjects. Because data from only one subject per arm were collected, these data are not reported to preserve subject privacy.||||||
1416418|NCT01126723|Primary|Frailty Index|Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.|post-intervention|per protocol|||participants|||Number
1416419|NCT01126671|Secondary|Assessment of Bone Markers at Follow-up|After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.|12 weeks||||ug/L||Standard Deviation|Mean
1416420|NCT01126671|Secondary|Baseline Assessment of Bone Markers|Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation|Baseline||||ng/ml||Standard Deviation|Mean
1416423|NCT01126619|Secondary|Number of Participants With Adverse Events (AEs)|"The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above.~Please see the Adverse Event module below for additional details."|24 Weeks|All enrolled participants.|||participants|||Number
1416424|NCT01126619|Secondary|Percent Change From Baseline in Work Productivity and Activity Impairment|"The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):~Percent work time missed in the last 7 days due to problems associated with psoriasis;~Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;~Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;~Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.~Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. The first 3 domains (work time missed, work impairment and overall loss of work productivity) were assessed on a sub-group of participants who had full time jobs (n=30).|||percent change||Full Range|Mean
1416425|NCT01126619|Primary|Percentage of Participants With 75% Reduction in PASI Score|The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||percentage of participants|||Number
1416426|NCT01126619|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.~Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100."|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||percent change||Full Range|Mean
1416427|NCT01126619|Secondary|Static Physician Global Assessment (PGA) of Psoriasis|"In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale:~Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis."|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||participants|||Number
1416428|NCT01126619|Secondary|Dynamic Patient Global Assessment (PGA) of Change in Psoriasis|In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||scores on a scale||Standard Deviation|Mean
1416429|NCT01126619|Secondary|Dynamic Physician Global Assessment (PGA) of Change in Psoriasis|In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from –5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement).|Baseline and Week 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||scores on a scale||Standard Deviation|Mean
1416430|NCT01126619|Primary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100.|Baseline and Weeks 4, 8, 16 and 24|Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24.|||Percent change||Standard Deviation|Mean
1416431|NCT01126593|Primary|Pain Scores|Pain was measured via Visual Analong Scale in measurement (0-100mm).|O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.||||mm||Standard Deviation|Mean
1416432|NCT01126580|Secondary|Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 concentration data.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
1416555|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416433|NCT01126580|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin.|||participants|||Number
1416434|NCT01126580|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks plus 30-day follow up|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.|||participants|||Number
1416435|NCT01126580|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
1416436|NCT01126580|Secondary|Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin. Only pre-rescue measurements were used.|||events|||Number
1416437|NCT01126580|Secondary|Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies|A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks.|Baseline through 52 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
1416438|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Serum Calcitonin||Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||picograms per milliliter (pcg/mL)||Inter-Quartile Range|Median
1416439|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes|Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter (U/L)||Inter-Quartile Range|Median
1416440|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides|Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable triglyceride data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||percentage change in triglycerides||Inter-Quartile Range|Median
1416441|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)|Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable LDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||percentage change in LDL-C||Inter-Quartile Range|Median
1416442|NCT01126580|Secondary|Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)|Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HDL-C data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing|||percentage change in HDL-C||Inter-Quartile Range|Median
1416556|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|"Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions Do you have flushing?."|24 weeks|LOCF, Complete Case ITT Population|||participants|||Number
1416443|NCT01126580|Secondary|Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol|Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable cholesterol data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage change in total cholesterol||Inter-Quartile Range|Median
1416444|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable blood pressure data.|||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
1416445|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1416446|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1416447|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable ECG QTcF interval or PR interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
1416448|NCT01126580|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin.|||participants|||Number
1416449|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score|The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5=“extremely” to 1=“not at all.” For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DSC-r data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1416450|NCT01126580|Secondary|Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQc data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1416458|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable fasting blood glucose data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1424558|NCT01059760|Primary|Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1416451|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1416452|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1416453|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score."|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1416454|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
1416455|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)|Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable BMI data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
1416456|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Body Weight|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1416457|NCT01126580|Secondary|Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate.|Baseline, 26 weeks, and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable SMBG data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1416557|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416459|NCT01126580|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) of Less Than 7% and Less Than or Equal to 6.5% at 26 and 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model.|26 weeks and 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1416460|NCT01126580|Secondary|Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1416461|NCT01126580|Primary|Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication [OAM] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who received at least one dose of LY2189265 or Metformin with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1416462|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Pain in Participants With MCII|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416463|NCT01126541|Secondary|Percentage of Participants With MCII in Pain|Participants were asked how their pain had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse pain.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1416464|NCT01126541|Secondary|Patient Global Assessment of Pain in Participants Reporting Acceptable Symptoms Using PASS|Patient Global Assessment of Pain assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. Higher values correspond to worst state of participant (high pain levels).|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416465|NCT01126541|Secondary|Percentage of Participants With Acceptable Symptom State in Pain Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
1416466|NCT01126541|Secondary|Change From Baseline in HAQ-DI in Participants With MCII|HAQ-DI was assessed in participants with MCII. HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1416467|NCT01126541|Secondary|Percentage of Participants With MCII in Functioning|Participants were asked how their functioning had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
1416477|NCT01126541|Secondary|HAQ-DI Scores|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1416468|NCT01126541|Secondary|HAQ-DI Scores in Participants Reporting Acceptable Function Using PASS|HAQ-DI was assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours). HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1416469|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Symptom State in Functioning Assessed Using PASS|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of function they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of function they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
1416470|NCT01126541|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity in Participants With MCII|The Patient's Global Assessment of Disease Activity was assessed in participants reporting MCII on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Baseline, Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416471|NCT01126541|Secondary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) in Disease Activity|Participants were asked how their disease activity had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more disease activity.|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
1416472|NCT01126541|Secondary|Patient Global Assessment of Disease Activity in Participants Reporting Acceptable Symptoms Using PASS|The Patient's Global Assessment of Disease Activity assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Week 24, 12 and 24 weeks after 1st retreatment|ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416473|NCT01126541|Secondary|Percentage of Participants Reporting Acceptable Disease Activity Symptom State Assessed Using Patient Acceptable and Unacceptable Symptom State (PASS)|"Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of disease activity they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered unacceptable."|Week 24, 12 and 24 weeks after 1st retreatment|ITT population|||percentage of participants|||Number
1416474|NCT01126541|Secondary|Medical Outcomes Study Sleep Scale (MOS-Sleep) Composite Sleep Problems 6 (SLP6) Index|The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The SLP6 index is comprised of 6 items: provides a summary of sleep problems and contains questions from the sleep disturbance, sleep adequacy, respiratory impairment, and somnolence domains. The SLP6 index score ranges between 0 and 100, with higher values corresponding to more sleep problems.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population;n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1416475|NCT01126541|Secondary|SF-12 Mental Health Composite Score|Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1416476|NCT01126541|Secondary|Short Form 12 (SF-12) Physical Health Composite Score|Physical and Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1416478|NCT01126541|Secondary|Total Mean Dose of Cortisone Between Week 24 and Week 104|All cortisone intakes were taken into account, including oral, IV (including the cortisone administration before the rituximab infusion), intramuscular and intra-articular.|Week 24 to Week 104|ITT population|||mg||Standard Deviation|Mean
1419472|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy|within 6 months of provider recommendation||||participants|||Number
1416480|NCT01126541|Secondary|Participant Assessment of Fatigue|"Participants were asked to rate their level of fatigue over the last 7 days on a 100-mm VAS. The left-hand extreme of the line equals 0 mm, and is described as “no fatigue” and the right-hand extreme equals 100 mm as “extreme fatigue. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high levels of fatigue)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416481|NCT01126541|Secondary|Patient's Global Assessment of Pain|"The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain. Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels)."|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416482|NCT01126541|Secondary|Patient Global Assessment of Disease Activity|The Patient's Global Assessment of Disease Activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416483|NCT01126541|Secondary|Physician's Global Assessment of Disease Activity|The Physician’s Global Assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity). Physicians were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high disease activity).|Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1416484|NCT01126541|Secondary|Percentage of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at 24 Weeks After Treatment|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1416485|NCT01126541|Secondary|Percentage of Participants With Rheumatoid Factor (RF) at 24 Weeks After Treatment|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 international units per milliliter (IU/mL) is considered positive.|Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1416486|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Retreatment by EULAR Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Week 24, 24 weeks after 1st retreatment, 24 weeks after 2nd retreatment|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1416487|NCT01126541|Secondary|Percentage of Participants Achieving a Response During Initial Treatment by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.|Day 15, Weeks 6, 12, and 24|Overall population|||percentage of participants|||Number
1416488|NCT01126541|Secondary|Percentage of Participants Achieving American College of Rheumatology 20%, 50%, and 70% Improvement (ACR20/ACR50/ACR70)|ACR20/50/70 response defined as ≥20%, 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%, 50%, or 70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: Patient Global Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity (on a visual analog scale [VAS]); Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP.|Week 24 of the initial treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population|||percentage of participants|||Number
1416489|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
1420243|NCT01096446|Secondary|Regain Birthweight|Infants in both groups weights were monitored to determine if giving higher infusions of intravenous fat emulsion helped the infants regain their birthweight sooner.|First 2 weeks of life|||||||
1416490|NCT01126541|Secondary|Duration of DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP ≤3.2) during first course of treatment (at any point) were included in the analysis.|||weeks||95% Confidence Interval|Median
1416491|NCT01126541|Secondary|Duration of DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
1416492|NCT01126541|Secondary|Duration of DAS28-CRP Remission After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; only participants with a response (DAS28-CRP <2.6) during initial treatment (at any point) were included in the analysis.|||weeks||95% Confidence Interval|Median
1416493|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
1416494|NCT01126541|Secondary|Time to Achieve DAS28-CRP ≤3.2 After the First Course of Treatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population|||weeks||95% Confidence Interval|Median
1416495|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After Retreatment|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population; n=number of participants assessed at a given visit.|||weeks||95% Confidence Interval|Median
1416496|NCT01126541|Secondary|Time to Achieve DAS28-CRP Remission After the First Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population|||weeks||95% Confidence Interval|Median
1416497|NCT01126541|Secondary|DAS28-CRP AUC Weighted Time|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104|ITT population|||units on a scale*week||Standard Deviation|Mean
1416498|NCT01126541|Secondary|Percentage of Participants Achieving Clinical Remission (DAS28-CRP <2.6) or Low Disease Activity (DAS28-CRP ≤3.2)|Percentage of participants with clinical remission and low disease activity as measured by DAS28-CRP for Arm A and Arm B at Week 24 of the Initial Treatment, at 24 weeks after first re-treatment, and at 24 weeks after second retreatment. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity and <2.6 = remission.|Week 24 of the Initial Treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1416499|NCT01126541|Primary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) Area Under the Curve (AUC) at Week 104|DAS28-CRP was based on joint counts, overall participant assessment, and serum CRP levels (measured in milligrams per liter [mg/L]) at each visit. Joint counts included swollen joint count (SJC) and tender joint count (TJC). Total score range was 0 to 9.4; a higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and less than (<)2.6 equals (=) remission. The AUC of all DAS28-CRP values between Day 1 and Week 104 (15 values of protocol visits) was calculated using the trapeze method (AUC between t1 and t2=(t2-t1)*((DAS28-CRP at t1 + DAS28-CRP at t2)/2). The true visit dates were used to calculate the time between 2 DAS28-CRP evaluations. All the AUC were censored at Week 104 (linear extrapolation using the 2 last DAS28-CRP values (Weeks 96 and 104) to obtain the “true” DAS28-CRP value at the “true” Week 104).|Week 104|Per Protocol (PP) population: all randomized participants in the Intent-to-Treat (ITT) population (defined as all randomized participants) without major protocol violations. Participants were grouped according to their initially assigned treatment arm irrespective of the treatment actually received.|||score on a scale*week||Standard Error|Mean
1416558|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416500|NCT01126541|Secondary|DAS28-CRP and Changes From Baseline to Week 24 in DAS28-CRP by Retreatment Course|DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Day 1, 24 weeks following each infusion up to 72 Weeks|ITT Population; number (n)=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1416501|NCT01126541|Secondary|DAS28-CRP During the Initial Treatment|Mean DAS28-CRP at Week 24 of the Initial Treatment study. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.|Days 1 and 15, and Weeks 6, 12, and 24|Overall population: all participants with at least one treatment intake.|||units on a scale||Standard Deviation|Mean
1416502|NCT01126437|Secondary|Time to Death From Major Adverse Cardiovascular Event (MACE)|The results presented below are number of patients with death from MACE.|Up to 3 years|TS including vital status follow−up, DAS|||Number of deaths from MACE|||Number
1416503|NCT01126437|Secondary|Time to Onset of First Major Adverse Cardiovascular Event (MACE)|Time to onset of first major adverse cardiovascular event (MACE). MACE was defined as: Fatal event in the system organ classes of cardiac and vascular disorders, Preferred terms: sudden death, cardiac death, sudden cardiac death, Outcome events of myocardial infarction (serious and non-serious), Outcome events of stroke (serious and non-serious) and Outcome events of TIA (serious and non-serious). The results presented below are for the number of patients with MACE.|Up to 3 years|Treated set - on treatment only|||number of patients with MACE|||Number
1416504|NCT01126437|Secondary|Time to First Moderate to Severe COPD Exacerbation|"COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).~Exacerbations classified as follows:~Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.~Results presented below are number of patients with moderate to severe exacerbations."|Up to 3 years|treated set - on treatment only|||number of patients with event|||Number
1416505|NCT01126437|Secondary|Number of Hospitalizations Associated With COPD Exacerbation|Total number of hospitalizations associated with COPD exacerbation.|Up to 3 years|treated set - on treatment only|||number of hospitalizations|||Number
1416506|NCT01126437|Secondary|Time to First Hospitalization Associated With COPD Exacerbation|The results presented below are for the patients with hospitalizations due to COPD exacerbations.|Up to 3 years|treated set - on-treatment only|||Number of patients with event|||Number
1416507|NCT01126437|Secondary|Number of COPD Exacerbations|"The number of COPD exacerbations. COPD exacerbation defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines)."|Up to 3 years|Treated Set - on treatment only|||number of COPD exacerbations|||Number
1416508|NCT01126437|Secondary|Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)|Trough forced expiratory volume in one second (FEV1) over 120 weeks (in a substudy of 1370 patients)|Up to 3 years|SSS - PFT - Sub-study set (pulmonary function testing). This analysis set included all subjects in the TS who signed informed consent to participate in the spirometry sub-study and had at least baseline and one on-treatment trough FEV1.|||Liter||Standard Error|Least Squares Mean
1416509|NCT01126437|Primary|Time to First COPD Exacerbation|"Defined as a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment where a complex of lower respiratory event/symptoms was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where a required change in treatment includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines).~Onset of exacerbation was defined by the onset of first recorded symptom. The end of exacerbation was decided by the investigator based on clinical judgement.~Exacerbations were classified as follows:~Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization."|Up to 3 years|Treated set (TS, on-treatment only)|||days to event||95% Confidence Interval|Median
1416510|NCT01126437|Primary|Time to All-Cause Mortality|Number of patients with all-cause mortality|Up to 3 years|Death analysis set (DAS) including vital status follow-up: This analysis set included all randomized subjects excluding only subjects who were documented as not treated.|||Number of deaths|||Number
1416534|NCT01126268|Secondary|Number of Participants Who Were a Therapeutic Success|Therapeutic response was determined from the clinical response and the microbiological response. Patients who qualified as both a “clinical success” and a “microbiological success” were deemed a “therapeutic success,” and all others were deemed “therapeutic failures.”|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416559|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416511|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Speed of Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Speed of Memory was calculated from the sum of 4 cognitive function speed tests: numeric and spatial working memory and word and picture recognition. A low score reflects that a person is able to recall a name, a face or any other item fast from the episodic secondary memory; a positive change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||msec||Standard Deviation|Mean
1416512|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (i.e. an event or a name) and a negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||Scores on a scale||Standard Deviation|Mean
1416513|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Quality of working memory is calculated from the sum of two cognitive function sensitivity tests: Numeric Working Memory Sensitivity and Spatial Working Memory Sensitivity, and ranges from -2 to 2. A higher score reflects a good working memory and a negative change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||Scores on a scale||Standard Deviation|Mean
1416514|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score – Continuity of Attention|Cognitive effects were assessed using a computerized assessment system at time points close to the predicted time of maximum plasma concentration for solifenacin and oxybutynin. For continuity of attention, the number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||Scores on a scale||Standard Deviation|Mean
1416515|NCT01126424|Secondary|Change From Baseline in Postural Stability Test|"The postural stability test measures the ability to stand upright without moving, and was assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration for solifenacin and oxybutynin. Using apparatus modeled on the Wright Ataxia-meter, a cord from the meter is attached to the patient who is required to stand as still as possible with feet apart and eyes closed for 1 minute.~The amount of sway is expressed as the total angular movement, summed regardless of sign, in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Wright (1971) described a range of 20-30 units as a normal range for adults with eyes wide open, increasing by 50 to 100% with eyes shut."|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||1/3 degree of angle of sway||Standard Deviation|Mean
1416535|NCT01126268|Secondary|Microbiologic Response at Follow up as Assessed by a Rating Scale|Microbiological response was determined by the investigator at the follow-up visit using the following microbiological outcomes: (1) microbological eradication, (2) presumed microbiological eradication, (3) presumed microbiological improvement, (4) microbiological persistence, (5) presumed microbiological persistence, (6) unable to determine, (7) new pathogen, and (8) colonization. Patients who were designated microbiological eradication, presumed microbiological eradication, presumed microbiological improvement, or colonization as defined in numbers 1, 2, 3, and 8 above were considered a “microbiological success” while all others were considered “microbiological failure.”|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416516|NCT01126424|Primary|Change From Baseline in Cognitive Function Composite Score - Power of Attention|Cognitive effects were assessed at the end of each treatment period using a computerized assessment system at time points close to the predicted time to attain maximum plasma concentration (Tmax) for solifenacin (6 hours) and oxybutynin (2 hours). Power of attention is calculated from the sum of three cognitive function speed tests: Simple Reaction Time, Choice Reaction Time and the Speed of Detections in Digit Vigilance task. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment.|Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.|The number of participants analyzed represents the Safety Analysis Subset 1 (SAF1), consisting of all randomized patients who took at least one dose of the study medication and who completed the cognitive function tests for at least two treatment periods. The number of participants per arm is consistent for all categories / rows of the data table.|||msec||Standard Deviation|Mean
1416517|NCT01126359|Secondary|Break-through Narcotic Requirement|Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.|20 minutes||||Narcotic Requirements (mg)||95% Confidence Interval|Mean
1416518|NCT01126359|Primary|Visual Analog Scale Pain Score|Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).|20 minutes||||Visial Analog Pain Score (VAS)||95% Confidence Interval|Mean
1416519|NCT01126268|Secondary|Number of Participants Reporting Any Adverse Event (AE)|AEs included burning at application site, upper respiratory infection, furuncle, cough, and a rash at a site other than the application site. See the Adverse Events section for more detailed information.|baseline to 6 to 8 days after treatment|All participants who received at least 1 dose of Retapamulin (Altabax)|||participants|||Number
1416520|NCT01126268|Secondary|Wound Size at Follow up|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||cm^2||Standard Deviation|Mean
1416521|NCT01126268|Secondary|Wound Size at Baseline|Wound size area was determined by measuring the greatest length of the wound in two perpendicular dimensions with a standard metric ruler. The two measurements were multiplied together to provide an estimate of the overall wound size. Surrounding erythema was not included in the measurement.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||cm^2||Standard Deviation|Mean
1416522|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416523|NCT01126268|Secondary|Pain (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416524|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416525|NCT01126268|Secondary|Tissue Warmth (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416526|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416527|NCT01126268|Secondary|Tissue Edema (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416528|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416529|NCT01126268|Secondary|Crusting (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416530|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416531|NCT01126268|Secondary|Purulence (Sign and Symptom of Infection) at Baseline|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|baseline|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416532|NCT01126268|Secondary|Erythema (Sign and Symptom of Infection) at Follow up|Signs and symptoms of infection were classified as one of the following: absent, minimal, moderate, or severe.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1421615|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Adults|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4 to Day 28|Adults ages >= 17 years|||ng/mL||Standard Deviation|Mean
1416536|NCT01126268|Secondary|Clinical Response at Follow up as Assessed by a Rating Scale|Clinical response was based on clinical evaluation by the investigator at the follow-up visit using a predefined scale with the following categories: (1) clinical success, (2) clinical improvement, (3) no change, (4) clinical failure, and (5) unable to determine. Patients who were designated as clinical success as defined in number 1 above were considered a true “clinical success” while all others were considered a “clinical failure.” Patients were classified with an outcome of “unable to determine” if they missed their follow-up visit or refused clinical examination.|6 to 8 days after treatment|All participants who had a pathogen isolated from the treatment area at baseline upon microbiological testing|||participants|||Number
1416537|NCT01126268|Primary|Number of Participants Whose Wound Cultures Were Positive for MRSA and Who Were Determined to be a Clinical Success at the Follow-up Visit|Clinical success is defined as no further signs or symptoms of infection present, including erythema, purulence, crusting, edema, warmth and pain.|6 to 8 days after treatment|Participants whose wound cultures were positive for MRSA|||participants|||Number
1416538|NCT01126099|Secondary|Days in Study|The number of days participants remained in the study during the Double Blind Phase. Please note that although the length of follow-up designated in the protocol was 12 weeks, a number of participants were in this phase longer (e.g. the dose titration phase took longer than 3 weeks, assessments were delayed due to scheduling conflicts, etc.) Therefore the length of time in the Double Blind Phase can exceed 12 weeks (84 days).|12 weeks after Baseline|7 participants in the prazosin group were in the double-blind phase longer than 12 weeks (84 days). 4 participants in the placebo group were in the double-blind phase longer than 12 weeks (84 days).|||days||Standard Deviation|Mean
1416539|NCT01126099|Primary|Change in Neuropsychiatric Inventory Score|Neuropsychiatric Inventory score change from Baseline to last observation.The Neuropsychiatric Inventory is a scale that quantifies behavioral and psychiatric symptoms in patients with dementia. The scale ranges from 0 to 144, with 0 being no symptoms.|12 weeks|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.|||units on a scale||Standard Deviation|Mean
1416540|NCT01126099|Secondary|Change in Brief Psychiatric Rating Scale Total Score|Brief Psychiatric Rating Scale score change from Baseline to last observation. The Brief Psychiatric Rating Scale measures 18 psychiatric symptom domains. The scale ranges from 18 to 126, where 18 indicates no psychiatric symptoms.|12 Weeks after Baseline|One study participant in the Placebo group dropped out prior to first follow-up, although this subject is included in the statistical analysis to provide information on the outcome at baseline.|||units on a scale||Standard Deviation|Mean
1416541|NCT01126099|Primary|Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change|This scale represents the raters overall impression of improvement or worsening, and is assessed at the last visit. 1 = Marked improvement, 1 = Moderate improvement, 3 = Minimal improvement, 4 = No change, 5 = Minimal worsening, 6 = Moderate worsening, 7 = Marked worsening.|12 Weeks after Baseline|Any participant who had at least one follow-up assessment was included in the analysis. One participant in the Placebo group did not return for follow-up, and therefore was not included in the analysis.|||units on a scale||Standard Deviation|Mean
1416542|NCT01126060|Primary|Postoperative Drainage Amount|method : measurement of drainage fluids from negative suction system every 8 hr until daily total amount reduces under 20mL|serial measurement from 1day to 4day after surgery||||mL||Standard Deviation|Mean
1416543|NCT01125930|Secondary|Skin Irritation Assessed by Facial Burning Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
1416544|NCT01125930|Secondary|Skin Irritation Assessed by Facial Itching Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
1416545|NCT01125930|Secondary|Skin Irritation Assessed by Facial Stinging Upon Product Application||2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
1416546|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.|||participants|||Number
1416547|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416548|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416549|NCT01125930|Secondary|Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing|Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416550|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Dryness/Irritation|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416551|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Facial Edema|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416552|NCT01125930|Secondary|Severity of Erythematotelangiectatic Signs: Telangiectasia|Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.|2, 6, 12, 18 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1419119|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set|||percentage of participants|||Number
1416560|NCT01125930|Secondary|Molecular Evidence of Photodamage|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).|24 weeks|ITT Population that completed baseline and week 24 biopsies|||fold change||Standard Deviation|Mean
1416561|NCT01125930|Secondary|Molecular Markers of Inflammation|These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).|24 weeks|ITT Population that completed baseline and Week 24 biopsies|||fold change||Standard Deviation|Mean
1416562|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Papulopustular|Signs of other rosacea subtypes includes papulopustular, inflammatory papule count|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population|||inflammatory papule||Standard Deviation|Mean
1416563|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416564|NCT01125930|Secondary|Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea|Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea|2, 6, 12, 18 and 24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416565|NCT01125930|Secondary|Photodamage|Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.|24 weeks|LOCF, Complete-Case ITT Population|||participants|||Number
1416566|NCT01125930|Secondary|Quality of Life|The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|2, 6, 12, 18, 24 weeks|LOCF, Complete-Case ITT Population|||units on a scale||Standard Deviation|Mean
1416567|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|LOCF, Complete-Case ITT population|||participants|||Number
1416568|NCT01125930|Primary|Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)|Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin|24 weeks|Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population|||participants|||Number
1416569|NCT01125917|Primary|Number of Participants With Adverse Events (AEs) as a Measure of Safety|The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).|52-week extension phase|The Extension Safety Population (N = 354) consisted of all subjects who received at least 1 dose of the open-label BTDS extension study drug, and had at least 1 safety assessment during the extension phase.|||participants|||Number
1416570|NCT01125813|Primary|Efficacy of Treating Bleeding Episodes|"At the end of a bleeding episode, efficacy was assessed as:~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated"|After each bleeding episode, up to 6 month||||Percentage of treatments|bleeding episodes||Number
1416571|NCT01125813|Primary|Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months|Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.|At least 50 Exposure Days and at least 6 months|All subjects who started prophylactic treatment were evaluated.|||Bleeds per month||Standard Deviation|Mean
1416572|NCT01125800|Primary|Percentage of Participants With Objective Response Rate (ORR) by Treatment|The tumor response to the sonidegib treatment was measured by ORR. The ORR was defined as the percentage of participants with partial response or complete response as their best overall response. Participants with stable disease, progressive disease tumor assessment were considered as non-responders. Response evaluation criteria was gadolinium chelate-enhanced brain tumor magnetic resonance imaging (Gd-MRI) for Medulloblastoma and central nervous system (CNS) tumors and response evaluation criteria in solid tumors (RECIST) version 1.0 for non-CNS tumors assessed by MRI. Complete Response (CR), Progressive Disease (PD) and Incomplete Response/Stable Disease (SD) were defined as disappearance of all non-target lesions, unequivocal progression of existing non-target lesions and Neither CR nor PD, respectively.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.|||Percentage of participants|||Number
1416573|NCT01125800|Secondary|Duration of Response by Treatment|Duration of overall response (complete response (CR) or partial response (PR)) was calculated for those participants whose best overall response was CR or PR. The start date was the date of the first documented tumor response (CR or PR) and the end date was the date of the event defined as the first documented progression or death due to underlying cancer or after the same treatment line. If a participant did not have a progression or death, the duration of response was censored at the date of last adequate tumor assessment in that treatment line.|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|"The analysis was performed in FAS population. Here Number of participants analysed” signifies treatment responders for the specified reporting group."|||months||Full Range|Median
1416574|NCT01125800|Secondary|Percentage of Pediatric Participants With Objective Response Rate (ORR) by Hedgehog (Hh) Signaling Pathway Status|ORR was determined in the participants with mutations on Hh gene (Hh positive) and the participants without mutations on Hh gene (Hh negative).|Baseline, Day 28 of Cycle 2, End of treatment (Within 14 days of last dose)|60 patients with known (Hedgehog) Hh pathway activation status were analyzed, 10 patients, including all 5 patients with an objective response (3 with pediatric) , were Hh-positive (+). No Hh-negative patient had an objective response.|||% pediatric Hh + responders|||Number
1416575|NCT01125800|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sonidegib in Phase I|Maximum observed plasma concentration following drug administration was calculated from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||nanograms/millitres(ng/mL)||Standard Deviation|Mean
1416576|NCT01125800|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sonidegib in Phase I|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration time data.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in PAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||hours||Full Range|Median
1416577|NCT01125800|Secondary|Area Under the Drug Concentration Time Curve From Time Zero to 24 Hours After Dosing (AUC0-24h) of Sonidegib in Phase I|AUC(0-24h) was defined as the area under the drug concentration time curve calculated using linear trapezoidal summation from time zero to 24 hours after dosing.|Pre-dose, 0.5, 1, 2, 4, 7 hours (± 15 min) post-dose at Day 1 and Day 22 of Cycle 1|The analysis was performed in pharmacokinetic analysis set (PAS), defined as all the participants who received at least one (full or partial) dose of sonidegib and provided at least one evaluable pharmacokinetic (PK) blood sample. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||nanograms*hours/millilitres (ng*hr/mL)||Standard Deviation|Mean
1416578|NCT01125800|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs were defined as AEs that were suspected to be related to study treatment as per investigator. On-treatment deaths were deaths which occurred up to 30 days after last date of study treatment.|Baseline (start of study treatment) up to End of treatment (Within 14 days of last dose)|The analysis was performed in safety set (SS), defined as all the participants who received at least 1 dose of sonidegib.|||participants|||Number
1416579|NCT01125800|Primary|Maximum Tolerated Dose (MTD) of Sonidegib for Prolonged Use|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose-limiting toxicity (DLT), based on Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications.k|Baseline, End of dose escalation part (Day 42)|The MTD for the pediatric population was not established in this study. MTD was not achieved since 1 or no DLT was observed. The recommended phase II dose was established based on the safety, pharmacokinetics, and clinical responses observed.|||mg/m^2|||Number
1416580|NCT01125800|Primary|Number of Participants With Dose-limiting Toxicities (DLT) in Phase I|DLT was defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications. DLT included any grade 3 or 4 clinically-evident toxicity, Hematology: ≥ CTCAE grade 3 neutropenia (ANC <1.0x10^9/L); ≥ CTCAE grade 3 thrombocytopenia (platelets <50x10^9/L); ≥ CTCAE grade 3 anemia (Hgb <80 g/L); Febrile neutropenia (ANC <1x10^9/L, fever ‡ 38.5°C), Renal: ≥ CTCAE grade 3 serum creatinine (>3xULN), Hepatic: ≥ CTCAE grade 3 total bilirubin (>3xULN); ≥ 10xULN ALT elevation; grade 2 total bilirubin (>1.5ULN) together with ≥ grade 3 ALT elevation (>5xULN), Cardiac: ≥ CTCAE grade 3, Other AEs: ≥ CTCAE grade 3 vomiting or nausea despite optimal antiemetic therapy, diarrhea despite optimal antidiarrheal treatment.|Baseline, End of dose escalation part (Day 42)|The analysis was performed in full analysis set (FAS), defined as all the participants who received at least one dose of sonidegib.|||participants|||Number
1416581|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With PMM Who Have an Average of 3 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. PMM participant subgroups (based on symptoms over the 3 menstrual cycles prior to study) – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the PMM subgroup and reported average of ≥3 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.|||Days per month||Standard Error|Mean
1416655|NCT01124955|Primary|Pain Assessed on a 10-point Numeric Pain Scale|The primary outcome is a visual analog pain scale (VAS), graded in centimeters from 0 to 10 (0=no pain; 10=worst imaginable pain), measured before (VAS 1) and after (VAS 2) the acupuncture session.|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)|||cm|Participants|Standard Deviation|Mean
1424559|NCT01059760|Primary|Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1416582|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.|||Days per month||Standard Error|Mean
1416583|NCT01125774|Secondary|Mean Monthly On-drug Headache Days During the Entire Study Period Among Participants With MRM or PMM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly on-drug headache days was calculated from diary data. “On-drug” headache day was a day, which had a valid diary entry and which followed a study drug dosing day, in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset into additional qualifying days (i.e., day following dosing day) was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 7 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days.|||Days per month||Standard Error|Mean
1416584|NCT01125774|Secondary|Mean Monthly Headache Days During Entire Study Period Among Participants With MRM Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. MRM participant subgroup (based on symptoms over the 3 menstrual cycles prior to study) - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.|||Days per month||Standard Error|Mean
1416585|NCT01125774|Primary|Mean Monthly Headache Days During Entire Study Period Among Participants With Menstrually-related Migraine (MRM) or Pure Menstrual Migraine (PMM) Who Have an Average of 5 or More Moderate or Severe Migraine Headaches Per Month at Baseline|Participants completed a headache diary each evening at bedtime, including recording headache duration and acute headache medication use. Mean monthly headache days was calculated from diary data. A headache day was defined as a day in which a headache (defined as headache pain ≥30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of additional headache days. Mean monthly rate was adjusted to 28 days. Participant subgroups (based on symptoms over the 3 menstrual cycles prior to study): PMM – In ≥2 out of 3 cycles attacks occur exclusively on Day 1 ± 2 of menstruation and at no other times of the cycle; MRM - In ≥2 out of 3 cycles attacks occur on Day 1 ± 2 of menstruation and additionally at other times of the cycle.|Up to 6 months|All randomized participants who were randomized only once, took at least 1 dose of study drug, had ≥1 post-randomization efficacy measurement, met the definition of the MRM or PMM subgroup and reported average of ≥5 moderate-severe migraine headaches/month at baseline. Participant must have ≥1 month with ≥4 dosing days and ≥7 diary days.|||Days per month||Standard Error|Mean
1416586|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Laboratory AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
1416594|NCT01125722|Secondary|Change in Mean Volume Per Void|Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||mL||Standard Deviation|Mean
1424560|NCT01059760|Primary|Change From Baseline in Participant Creatinine When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1416587|NCT01125774|Primary|Number of Participants With Laboratory AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A laboratory AE is an AE reported as a result of a laboratory assessment or test.|Up to 6 months|APaT population, which is all randomized participants who took at least one dose of study drug. Also to be included participant must have at least one post-baseline lab test. Participants were included in arm corresponding to the treatment actually taken. Participants who took both treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
1416588|NCT01125774|Primary|Number of Participants Who Discontinued Study Due to a Clinical AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 6 months|APaT population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
1416589|NCT01125774|Primary|Number of Participants With Clinical Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. A clinical AE is an AE reported as a result of a clinical examination or reported by the participant.|Up to 14 days after the last dose of study drug (Up to 6.5 months)|All Participants as Treated (APaT) population, which included all randomized participants who took at least one dose of study drug. Participants were included in the treatment arm corresponding to the study treatment actually taken. Participants who took both study treatments were included in the telcagepant 140 mg treatment arm.|||Participants|||Number
1416590|NCT01125748|Secondary|Time to the First Protocol-defined Severe Exacerbation|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.|||Weeks||95% Confidence Interval|Mean
1416591|NCT01125748|Primary|Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study|A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.|Baseline to the end of the study (up to 52 weeks)|Intent-to-treat population: All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1416592|NCT01125722|Secondary|Change in Mean Overactive Bladder Symptom Composite Score|The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||scores on a scale||Standard Deviation|Mean
1416593|NCT01125722|Secondary|Change in Mean Urgency Episodes Per Day|Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From Baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||number of urgency episodes per 24 hours||Standard Deviation|Mean
1416676|NCT01124786|Secondary|Change From Baseline in Pain Severity||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
1416677|NCT01124786|Secondary|Drug Tolerability and Toxicity||Every week, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
1416595|NCT01125722|Secondary|Change in Mean Daily Voiding Frequency|Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||number of voids per 24 hours||Standard Deviation|Mean
1416596|NCT01125722|Primary|Change in Mean Daily Urgency Incontinence Episodes|Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.|From baseline to Week 4 of active treatment|Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.|||number of incontinence episodes/24 hours||Standard Deviation|Mean
1416597|NCT01125605|Primary|Tolerability After Visit 2 and Visit 3|Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects|appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured|||participants|||Number
1416598|NCT01125605|Primary|Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation|The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits|||participants|||Number
1416599|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.~The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories PASCONAL® better, No difference and PASCONAL® worse."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values|||participants|||Number
1416600|NCT01125605|Primary|Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation|The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits|||participants|||Number
1416601|NCT01125605|Secondary|Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)|"Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.~The last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories “PASCONAL® better”, “No difference” and “PASCONAL® worse”."|appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)|exploratively, all participations with values|||participants|||Number
1416602|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
1416603|NCT01125605|Secondary|Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication|"The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
1416604|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment|"The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories improved, unchanged and worsened. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0)."|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
1416605|NCT01125605|Secondary|Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication|The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories “improved”, “unchanged” and “worsened”. For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was > 0).|begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))|exploratively, all participations with values|||participants|||Number
1416678|NCT01124786|Secondary|Cancer Antigen (CA)19-9 Response Rates||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
1424561|NCT01059760|Primary|Change From Baseline in Participant Potassium When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
1416606|NCT01125605|Secondary|Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration|"The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).~Decrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (< 4 weeks and >= 4 weeks)"|begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))|exploratively, all participations with values|||units on a scale||Standard Deviation|Mean
1416607|NCT01125605|Primary|Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3|The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).|begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)|descriptive; for all partcipations with values at the visits|||units on a scale||Standard Deviation|Mean
1416608|NCT01125566|Secondary|Overall Survival (OS)|"OS is defined as time from randomisation to death irrespective of the cause of the death.~For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date."|From randomisation to data cut-off (03Sep2013); Up to 37 months.|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not|||months||Inter-Quartile Range|Median
1416609|NCT01125566|Secondary|Best RECIST Assessment|"Best RECIST assessment is defined as CR, PR, stable disease (SD), PD or not evaluable by investigator (RECIST version 1.1).~CR for target lesions (TL): Disappearance of all target lesions.~CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Data collected until cut-off date 08Jun2013; Up to 34 months)|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not (One centre was excluded from analysis due to serious non-compliance, thus data from 5 patients in AV arm and 1 patient in TV arm were excluded)|||percentage of participants|||Number
1416610|NCT01125566|Secondary|Objective Response (OR)|"OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to RECIST 1.1.~Only data collected until the cut-off date 08Jun2013 were considered. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.~Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis)~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR"|Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Up to 34 months)|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not (One centre was excluded from analysis due to serious non-compliance, thus data from 5 patients in AV arm and 1 patient in TV arm were excluded)|||percentage of participants||95% Confidence Interval|Number
1416611|NCT01125566|Primary|Progression-free Survival (PFS)|"PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).~Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.~Progression of disease was determined if at least 1 of the following criteria applied:~At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm~Appearance of 1 or more new lesions~Unequivocal progression of existing non-target lesions"|From randomization until disease progression, death or data cut-off (08Jun2013); Up to 34 months|Randomised set (RS): The randomised set included all patients who were randomised to receive treatment, whether treated or not|||months||Inter-Quartile Range|Median
1416612|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction and for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.|||mL/mg||Standard Deviation|Mean
1416613|NCT01125514|Primary|Diuretic Efficacy Index 2 for Water Excretion|Efficacy of furosemide for water excretion (efficacy index 2) was defined by dividing urine volume by the urinary excretion of furosemide.Diuretic index 2 for water was calculated for the 0 to 4 hour fraction urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.|||mL/mg||Standard Deviation|Mean
1416679|NCT01124786|Secondary|ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years||Every 8 weeks|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
1416614|NCT01125514|Secondary|Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure was measured three times at 1 to 2-minute intervals. The mean of the three sitting blood pressure measurements was used as the average of the sitting office blood pressure. The msSBP and msDBP data were analyzed using a mixed effect model with fixed effects from treatment and treatment*time; random effect from patients and predose as covariate.|0.5 hour pre-dose, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose.|Safety analysis set include subjects that received study drug.|||mmHg||Standard Error|Least Squares Mean
1416615|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 24 Hours Postdose|Urine was collected 24 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 24 hours.|24 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
1416616|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 12 Hours Postdose|Urine was collected 12 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 12 hours.|12 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
1416617|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 8 Hours Postdose|Urine was collected 8 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 8 hours.|8 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
1416618|NCT01125514|Secondary|Urine Sodium and Potassium Excretion Per Treatment at 4 Hours Postdose|Urine was collected 4 hours postdose in all treatment groups for sodium and potassium analysis. Each patient was required to void their bladder before drug administration and at the end 4 hours.|4 hours postdose|All patients who received at least one dose of study drug and had evaluable pharmacodynamics (PD)data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol||Standard Deviation|Mean
1416619|NCT01125514|Secondary|Creatinine Clearance|Creatinine clearance= (Urine creatinine/Serum creatinine) x (Urine volume/(24*60)).|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PD data with no major protocol deviation in at least one period were included in the PD analysis set.|||mL/min||Standard Deviation|Mean
1416620|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Renal Clearance (CLR)|The renal clearance of drug [volume x time-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.|||L/h||Standard Deviation|Mean
1416621|NCT01125514|Secondary|Urine Pharmacokinetics (PK) of Furosemide: Amount of Drug Excreted Into the Urine From Time Zero to 24 Hours After Administration (Ae0-24)|The area under the plasma (or serum or blood) concentration-time curve from time zero to 24 h [mass × time × volume-1]|0 to 4, 4 to 8, 8 to 12 and 12 to 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set|||mg||Standard Deviation|Mean
1416622|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin, ss)|The minimum observed steady-state drug concentration in the plasma, blood, serum, or other body fluids at the end of the dosing interval during multiple dosing [amount x volume-1]|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set|||ng/mL||Standard Deviation|Mean
1416623|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Average Steady State Plasma Concentration During Multiple Dosing (Cav,ss)|The average steady-state drug concentration in the plasma, blood, serum, or other body fluids during multiple dosing [amount x volume-1]. This was estimated as AUCτ/τ|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All subjects with evaluable pharmacokinetic parameter data with no exclusion flags and no major protocol deviations.|||ng/mL||Standard Deviation|Mean
1416624|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Tmax was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable PK data with no major protocol deviation in at least one period were included in the PK analysis set|||Hours||Full Range|Median
1416625|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)|Cmax,ss was directly determined from the raw plasma concentration-time data.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set|||ng/mL||Standard Deviation|Mean
1416639|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)|SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Follow-up Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
1416680|NCT01124786|Secondary|Overall Survival in All Patients and Patients With hENT1 Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
1424562|NCT01059760|Primary|Change From Baseline in Participant Calcium When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1416626|NCT01125514|Secondary|Plasma Pharmacokinetics (PK) of Furosemide: Area Under the Plasma Concentration-time Curve (AUC)|"Pharmacokinetic (PK) parameters were determined from the plasma concentration time profile of furosemide using a non-compartmental method:~AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval~AUC (0-24): Area under the plasma concentration-time curve from time zero to 24 hours~AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated as the sum of linear trapezoids using non-compartmental analysis.~AUCinf: Area under the plasma concentration-time curve from time zero to infinity. AUCinf was calculated by adding AUClast and the value obtained from dividing the last measurable plasma concentration by λz, where λz was determined from automated linear regression of the last three time points with non-zero concentrations in the terminal phase of the log-transformed concentration-time profile"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post dose|All patients who received at least one dose of study drug and had evaluable Pharmacokinetic (PK) data with no major protocol deviation in at least one period were included in the PK analysis set.|||h*ng/mL||Standard Deviation|Mean
1416627|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 24 hour urine collection.|0 to 24 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol/mg||Standard Deviation|Mean
1416628|NCT01125514|Primary|Diuretic Efficacy Index 1 for Sodium Excretion|Efficacy of furosemide for sodium excretion (efficacy index 1) was defined by dividing urinary sodium excretion by the urinary excretion of furosemide. Diuretic index 1 for sodium was calculated for the for the total 0 to 4 hour urine collection.|0 to 4 hours|All patients who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data with no major protocol deviation in at least one period were included in the PD analysis set.|||mmol/mg||Standard Deviation|Mean
1416629|NCT01125202|Primary|Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|Baseline to 16 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
1416630|NCT01125202|Primary|Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls. The difference between measurement time points was determined.|Baseline to 8 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
1416631|NCT01125202|Primary|Time Specific Dietary Sodium Intake (16 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|16 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
1416632|NCT01125202|Primary|Time Specific Dietary Sodium Intake (8 Weeks)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|8 weeks|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
1416633|NCT01125202|Primary|Time Specific Dietary Sodium Intake (Baseline)|Dietary sodium intake was assessed via three 24-hour dietary recalls, including 1 dialysis weekday, 1 non-dialysis weekday, and 1 non dialysis weekend day. Recalls were entered into Nutrition Data System for Research, with sodium intake averaged across the 3 recalls.|Baseline|Some participants have missing sodium data due to missed dietary recalls.|||mg/day||Standard Deviation|Mean
1416634|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (16 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 16 week measurement time point.|16 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
1416635|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (12 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 12 week measurement time point.|12 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
1416636|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (8 Weeks)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to the 8-week measurement time point.|8 weeks|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
1416637|NCT01125202|Primary|Time Specific Interdialytic Weight Gain (Baseline)|Average interdialytic weight gains (kg/day) were calculated for the 1 week period prior to baseline measurement.|Baseline|Some participants have missing interdialytic weight gains due to missed hemodialysis treatments.|||kg/day||Standard Deviation|Mean
1416638|NCT01125189|Secondary|Percentage of Resistant Variants Associated With Virologic Failure|"Virologic failure was defined as:~Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment~<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment~Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment~HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24~HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)~Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow­up, after HCV RNA < LLOQ, TND at EOT.~The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome."|Follow-up Week 48|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1416640|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 12|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
1416641|NCT01125189|Secondary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.|Week 4|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
1416642|NCT01125189|Primary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (day 1) up to follow-up Week 48|All treated participants.|||participants|||Number
1416643|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)|SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Follow-up Week 24|All treated participants. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
1416644|NCT01125189|Primary|Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.|Weeks 4 and 12|All treated participants. Here, 'number of participants' analyzed (N) signifies number of participants evaluable for this outcome measure.|||percentage of participants||80% Confidence Interval|Number
1416645|NCT01125098|Secondary|To Verify the Duration of Hospitalization for Severe Exacerbation in COPD Patients Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the duration in days in case of hospitalization for severe COPD exacerbation in COPD patients in the study population, both in the PRO-CT-guided antibiotic treatment group and in the standard antibiotic treatment group.|Discharge/10 days-6 months||2014-11-30|11/2014||||
1416646|NCT01125098|Secondary|To Verify Changes in FEV1 Value in COPD Patients Comparing Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|COPD patients of the study population will undergo spirometry on visit 1, 4, 5, 7 in order to evaluate if there is change in FEV1 among COPD patients, both in the PRO-CT Group and in the standard Group.|Discharge/10 days-6 months||2014-11-30|11/2014||||
1416647|NCT01125098|Secondary|To Verify Survival in COPD Patients Comparing to Those Treated According to the PRO-CT Protocol Versus COPD Patients Treated With Standard Antibiotic Therapy.|We evaluate the number of deaths from any cause among COPD patients in the study population, in order to compare survival among patients both in PRO-CT group and in the standard group.|Discharge/10 days-6 months||2014-11-30|11/2014||||
1416648|NCT01125098|Secondary|To Evaluate if the PRO-CT-guided Decision Making to Shorten Antibiotic Therapy is Less Effective Than the Guideline Recommended Standard Antibiotic Treatment in Preventing Hospitalization.|We evaluate the number of hospital re-admissions for severe COPD exacerbation in COPD patients of the study population, both in the PRO-CT group and in the standard group, in order to assess if shortening antibiotic therapy taking into account the values of PRO-CT is less effective compared to a standard antibiotic treatment.|Discharge/10 days-6 months||2014-11-30|11/2014||||
1416649|NCT01125098|Secondary|Cost/Effectiveness of the Use of PRO-CT-guided Decision Making Protocol on Duration of Antibiotic Therapy in COPD Exacerbations.||Discharge /10 days-6 months|||||||
1416650|NCT01125098|Primary|To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy.|We prospectively recruited COPD patients hospitalized for severe exacerbation of COPD and followed them after discharge. The primary end point of the study was the number of patients with at least 1 exacerbation at 6 months after the index exacerbation that was the reason for their hospital admission.|6 months||||participants|||Number
1416651|NCT01124955|Secondary|Number of Anti-inflammatory Tablets Taken|Number of 50 mg sodium diclofenac pills taken per day|Days 3,7,14,21 and 28|Intention to treat (ITT)|||number of pills/day||Standard Deviation|Mean
1416652|NCT01124955|Secondary|Likert Improvement Assessment Scale|Likert improvement assessment scale is based on the patient’s opinion (LIKERT P) and assessor’s opinion (LIKERT A), categorized in 1=MB (much better), 2=SB (slightly better), 3=NC (no change), 4=SW (slightly worse) and 5=MW (much worse). This scale was was applied to each day of assessment. The numbers in the category titles represent the different days.|Days 0, 3, 7, 14 and 21||||scores on a scale||Standard Deviation|Mean
1416653|NCT01124955|Secondary|Quality of Life Assessed on the SF-36|Questionnaire Short-form-36 is a widely used generic health status questionnaire, validated for Portuguese with eight components and each components with scores from 0 to 100: higher scores denote greater quality of life.|Days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)|||scores on a scale|Participants|Standard Deviation|Mean
1416654|NCT01124955|Secondary|Roland-Morris Disability Questionnaire (RM)|"Secondary outcomes includes the Roland-Morris Disability Questionnaire (RM) for the assessment of functional capacity, with 24 items on low-back pain: higher scores denote poorer functional capacity.~0: better functional capacity 24: poorer functional capacity Range of score: the highest is 24 (poorer functional capacity) and lowest scores is 0 (better functional capacity)."|days 0, 3, 7, 14, 21 and 28|Intention to treat analysis (ITT)|||scores on a scale|Participants|Standard Deviation|Mean
1423523|NCT01069341|Secondary|Mean Number of PRP Laser Treatments|Mean number of PRP laser treatments required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded|||PRP Laser treatments||Standard Deviation|Mean
1416656|NCT01124916|Secondary|Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms.|6 Months|The analysis excludes three individuals assigned to the LASC cohort and two individuals assigned to the RASC cohort because they were lost to follow-up six months after intervention.|||units on a scale||Standard Deviation|Mean
1416657|NCT01124916|Primary|Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy|At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.|6 Weeks|The analysis for the primary outcome includes all randomized subjects.|||Dollars||Standard Deviation|Mean
1416658|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: Cmax|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for concentration max. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.|||ng/mL||Standard Deviation|Mean
1416659|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUClast|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve last. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.|||h*ng/mL||Standard Deviation|Mean
1416660|NCT01124864|Secondary|Pharmacokinetics (PK) of Plasma Concentration of AUY922 and Its Metabolite BJP762: AUCinf|Summary of PK parameters for all patients one hour post 70 mg/m2 AUY922 infusion for area under the curve infinity. There are discrepancies between sample numbers and study population because PK samples were not collected from all study subjects and thus were not analyzed.|1 hour after infusion|PK analysis subset - All patients who received at least one dose of AUY922 in Cycle 1 and had at least one measurable post-dose AUY922 concentration.|||h*ng/mL||Standard Deviation|Mean
1416661|NCT01124864|Secondary|Progression Free Survival (PFS) Rate as Per Investigator Using Kaplan Meier Estimates - Per Investigator Radiological Review|Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment. A Novartis modified response evaluation criteria in solid tumors RECIST 1.1 criteria was applied to CT/MRI imaging data when assessing any responses to AUY922 treatment. All images were evaluated locally by the investigator. All complete or partial responses were confirmed by a second assessment at least 4 weeks later.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.|||Percentage of participants|||Number
1416662|NCT01124864|Secondary|Overall Survival Rate Using Kaplan Meier Estimates - Per Investigator Radiological Review|Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.|Week 12, Week 18|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.|||Percentage of participants|||Number
1416663|NCT01124864|Primary|Response Assessment by Study Stratum - Per Investigator Assessment|The primary endpoint of the study was the investigator assessment of efficacy at 18 weeks in terms of response complete response (CR)/partial response (PR), stable disease (SD), or non clinical benefit (NCB) as assessed by response evaluation criteriain solid tumors (RECIST) version 1.0. ORR = patients with confirmed complete or partial response. Stable disease at 18 weeks = patients without response and with no assessment of progressive disease up to 18 weeks, but with an assessment of stable disease or better either within 2 weeks prior to the 18 week time point, or at the next non-missing assessment after the 18 week time point. No clinical benefit = all other patients.|18 weeks|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of AUY922.|||Participants|||Number
1416664|NCT01124838|Secondary|Change in VFQ-25 Subscore Ocular Pain From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The ocular pain subscore is calculated form the answers to 2 eye pain questions and ranges from 0 to 100, where higher scores or increases in score indicate less pain."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1416665|NCT01124838|Secondary|Change in VFQ-25 Subscore Near Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The near vision subscore is calculated from the answers to 3 near vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1416681|NCT01124786|Primary|Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression||Monthly follow up after treatment discontinuation until death, up to 1.5 years.|Analysis was per protocol and included hENT-1 low Intent to Treat (IIT) population.|||months||95% Confidence Interval|Median
1416666|NCT01124838|Secondary|Change in VFQ-25 Subscore Distance Vision From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The distance vision subscore is calculated from the answers to 3 distance vision-related questions and ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1416667|NCT01124838|Secondary|Change in Visual Functioning Questionnaire 25 (VFQ-25) Total Score From Baseline to the Final/Early Termination Visit|"The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.~The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning."|Baseline and Final/Early Termination Visit (up 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1416668|NCT01124838|Secondary|Percent Change in Central Retinal Thickness in Each Eye From Baseline to the Final/Early Termination Visit.|Central retinal thickness was measured using OCT and assessed by a central reader.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
1416669|NCT01124838|Secondary|Time to Optimal Coherence Tomography (OCT) Evidence of Macular Edema in At Least 1 Eye On or After Week 2|"Optical coherence tomography was performed at every visit using 1 of 3 approved machines. Images were evaluated by a central reader. Macular edema was defined as cystoid macular edema.~OCT evidence of macular edema on or after Week 2 was to be counted as an event. Dropouts due to reasons other than OCT evidence of macular edema were to be considered as censored observations at the time of dropping out."|From Baseline until the Final Visit (up to 80 weeks)|Intent to treat population with no macular edema at Baseline|||months||Inter-Quartile Range|Median
1416670|NCT01124838|Secondary|Change In Logarithm of the Minimum Angle of Resolution (LogMAR) Best Corrected Visual Acuity (BCVA) In Each Eye From Baseline to the Final/Early Termination Visit|Using corrective lenses based on that visit's refraction testing, participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||logMAR||Standard Deviation|Mean
1416671|NCT01124838|Secondary|Change in Vitreous Haze (VH) Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI) and SUN criteria:~Grade 0: No evident vitreous haze;~Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;~Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);~Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);~Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;~Grade 4+: Optic nerve head is obscured."|Baseline and Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1416672|NCT01124838|Secondary|Change in Anterior Chamber (AC) Cell Grade in Each Eye From Baseline to the Final/Early Termination Visit|"Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:~Grade 0 = < 1 cell~Grade 0.5+ = 1 - 5 cells~Grade 1+ = 6 - 15 cells~Grade 2+ = 16 - 25 cells~Grade 3+ = 26 - 50 cells~Grade 4+ = > 50 cells."|Baseline and at the Final/Early Termination Visit (up to 80 weeks)|Intent-to-treat population with a Baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1416673|NCT01124838|Primary|Time to Treatment Failure on or After Week 2|"Treatment failure was defined by the occurrence of a uveitis flare (the inability to maintain disease control). To be considered treatment failure, ≥ 1 of these criteria had to be present in at least 1 eye at Week 2 or all other visits:~New active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesions relative to Baseline~2-step increase relative to Baseline in anterior chamber cell grade or vitreous haze grade~Worsening of best corrected visual acuity by ≥ 15 letters relative to baseline.~Time to treatment failure was analyzed using the Kaplan-Meier method. Dropouts for reasons other than treatment failure at any time during the study were censored at the drop out date.~Per protocol, the primary analysis was performed in the Main Study population which included all randomized participants recruited outside Japan; for completeness results are also reported below for the Integrated dataset which includes participants recruited in Japan."|From Baseline until end of study (up to 80 weeks)|The intent-to-treat (ITT) population which included all randomized participants; 3 participants at 2 sites were excluded from the ITT due to incomplete efficacy source data and compliance issues.|||months||Inter-Quartile Range|Median
1416674|NCT01124786|Secondary|Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling||30 days after first dose|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
1416675|NCT01124786|Secondary|Change From Baseline in Health Status||Every 4 weeks, up to 1.5 years|Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.||||||
1416682|NCT01124643|Primary|Safety Evaluations||Baseline to 12 months|ITT population|||participants|||Number
1416686|NCT01124643|Secondary|Change From Baseline in New York Heart Association (NYHA) Functional Class|"Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea.~Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline to 12 months|ITT population.|||participants|||Number
1416687|NCT01124643|Secondary|Change From Baseline in the Minnesota Living With Heart Failure Questionnaire (MLHF- Q)|The MLHF-Q contains 21 questions with answers ranging from 0 (no) to 5 (very much). The final score ( 0 to 105) is the sum of the points for the 21 questions. A higher score indicates a worse quality of life.|Baseline to 12 months|ITT population. Number of participants analyzed signifies participants evaluable for this endpoint.|||units on a scale||Standard Deviation|Mean
1416688|NCT01124643|Secondary|Change From Baseline in Distance Walked in 6- Minute Walk Test (6MWT)||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.|||meters||Standard Deviation|Mean
1416689|NCT01124643|Secondary|Change From Baseline in Maximal Oxygen Consumption (VO2max) at Peak Exercise||Baseline to 12 months|ITT population. Test was not done or test was not valid for all participants.|||(mL/min/kg)||Standard Deviation|Mean
1416690|NCT01124643|Primary|Change From Baseline in Left Ventricular Mass Indexed to Height (LVMI)||Baseline to 12 months|The Intent-to-Treat (ITT) participant population in this study was defined as all participants who provided informed consent and received study drug. Participants who did not have left ventricular hypertrophy were not included in this analysis.|||g/m^2.7||Standard Deviation|Mean
1416691|NCT01124617|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416692|NCT01124617|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|Participants rated the overall quality of sleep last night as excellent, good, fair and poor.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416693|NCT01124617|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was related to How many times did the participant wake up during the night”. Lesser number signifies better sleep."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416694|NCT01124617|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was related to How long did the participant sleep last night. The mean change for the time in hours slept during the last night was reported."|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Hours||Standard Deviation|Mean
1416695|NCT01124617|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was related to “How long after bedtime or lights out did the participant fall asleep last night . Decrease in time indicates an improvement."|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Minutes||Standard Deviation|Mean
1416696|NCT01124617|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416697|NCT01124617|Secondary|Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent [no pain]) to 10 (extreme [pain as bad as you can image]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416785|NCT01124162|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1416698|NCT01124617|Secondary|Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale|The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.|Baseline and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416699|NCT01124617|Secondary|Number of Participants With Categorical Scores on Physician’s Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and ineffective."|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416700|NCT01124617|Secondary|Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8 and Week 12|FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416701|NCT01124617|Secondary|Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)|Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.|||Percentage of participants|||Number
1416702|NCT01124617|Secondary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.|||Units on a scale||Standard Deviation|Mean
1416703|NCT01124617|Primary|Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12|Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.|Baseline and Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
1416704|NCT01124604|Other Pre-specified|Serum Concentration of Tapentadol||Week 2, 4, 8, 12|Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 serum study drug concentration. 'N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||nanogram per milliliter||Standard Deviation|Mean
1416705|NCT01124604|Other Pre-specified|Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)|COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.|Week 12|Safety population included all the participants who received at least 1 dose of the study drug.|||Participants|||Number
1416706|NCT01124604|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12|RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as “Yes”/“No” where “Yes” is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416707|NCT01124604|Secondary|Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12|WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. ‘N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416708|NCT01124604|Secondary|Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12|SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416709|NCT01124604|Secondary|Number of Participants With Response Based on Overall Quality of Sleep Questionnaire|"Overall quality of sleep was addressed by the question: Please rate the overall quality of your sleep last night” and participants could choose one of the following options: excellent, good, fair or poor."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416710|NCT01124604|Secondary|Number of Participants With Awakenings Based on Sleep Questionnaire|"Number of awakenings was addressed by the question: How many times did you wake up during the night?'' and lesser number signified better sleep."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416711|NCT01124604|Secondary|Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12|"Time slept was addressed by the question: How long did you sleep last night? and the change from Baseline in time slept was reported."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Hours||Standard Deviation|Mean
1416712|NCT01124604|Secondary|Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12|"Sleep Latency was addressed by the question: How long after bedtime/lights out did you fall asleep last night? and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement."|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Minutes||Standard Deviation|Mean
1416713|NCT01124604|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12|BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1416714|NCT01124604|Secondary|Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416715|NCT01124604|Secondary|Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale|BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: “Do you have any pain today other than everyday kinds of pain?” on a 2-point scale of “yes” or “no”.|Baseline, Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416716|NCT01124604|Secondary|Number of Participants With Response Based on Physician’s Global Assessment Scale|"Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and not effective."|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416717|NCT01124604|Secondary|Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale|The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 8, Week 12|FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.|||Participants|||Number
1416786|NCT01124162|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1416718|NCT01124604|Secondary|Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)|Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.|Week 12|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.|||Percentage of participants||95% Confidence Interval|Number
1416719|NCT01124604|Secondary|Change From Baseline in 11-point Numerical Rating Scale (NRS)|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11|FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. LOCF method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
1416720|NCT01124604|Primary|Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12|Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.|Baseline, Week 12|Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
1416721|NCT01124448|Secondary|Evidence of Changes in the Immunological Profile of Milk||one year|||||||
1416722|NCT01124448|Secondary|Evidence of Changes in the Macronutrient and Electrolyte Profiles of Milk||One year|||||||
1416723|NCT01124448|Secondary|Evidence of Changes in the Metabolic Profile of Urine||One year|||||||
1416724|NCT01124448|Secondary|Evidence of Changes in Gene Expression of Somatic Cells Obtained From Milk Samples||one year|||||||
1416725|NCT01124448|Primary|Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts|Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk|one week||||log10 CFU/mL||95% Confidence Interval|Mean
1416726|NCT01124422|Secondary|Baseline Dyspnea Index (BDI) at Week 4 and Transition Dyspnea Index (TDI) at Week 8|The BDI-TDI is a multidimensional dyspnea measurement. The BDI, administered at Week 4, consisted of 3 items (functional impairment, magnitude of task in exertional capacity, and magnitude of effort) requiring recall over the previous 4 weeks. BDI scores ranged from 0 (very severe impairment) to 4 (no impairment); the summed total score = 0 to 12. The TDI, administered at Week 8 as a follow-up of the BDI, consisted of the same 3 items requiring recall over the previous 4 weeks. TDI scores ranged from -3 (major deterioration) to +3 (major improvement); the summed total score = -9 to 9.|BDI: Week 4; TDI: Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||Standard Error|Mean
1416727|NCT01124422|Secondary|Mean Change in Scores on the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS) Questionnaire From Week 4 to Week 8|The CRQ-SAS, a self-administered tool used to assess health-related quality-of-life (HRQOL), consists of 20 questions (q.) in 4 domains: Dyspnea (5 q.), Fatigue (4 q.), Emotional Function (7 q.), and Mastery (4 q.). Participants rated their experience on a 7-point scale in response to each q.: 1 (maximum impairment) to 7 (no impairment); higher scores indicate better HRQOL. Individual q. were equally weighted, and domain scores (range=1-7) were calculated as the mean across the non-missing items within each domain (domain scores were calculated although an individual item score was missing).|Week 4 and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||Standard Error|Mean
1416728|NCT01124422|Secondary|Mean Change in EIC at 2 to 3.5 Minutes During the Exercise Period From Baseline (Week 3) to Week 8|The EIC was measured at 2 to 3.5 minutes during the exercise period. Change from Baseline in EIC was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL||Standard Error|Mean
1416729|NCT01124422|Secondary|Mean Change in Ratio of Respiratory Rate (RR) to Tidal Volume (VT) or RR/VT at Isotime During the Course of the ESWT From Baseline to Week 8|The RR and VT of the participants at isotime were measured during the ESWT using the OMS. The ratio of RR per VT (value of RR divided by value of VT) at isotime was calculated. Change from Baseline in RR/VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||breaths/min/L||Standard Error|Mean
1416730|NCT01124422|Secondary|Mean Change in HR Per Time Slope During the Course of the ESWT Using Pulse Oximetry From Baseline to Week 8 (Non-OMS Subgroup)|HR was measured during the course of the ESWT in the non-OMS subgroup using pulse oximetry. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the ESWT. HR per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in HR was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed. A subgroup of participants specified sites provided cardio-respiratory and exercise IC measurements with the Oxycon Mobile System (OMS). Participants not at these sites formed the non-OMS subgroup.|||bpm/min||Standard Error|Mean
1416731|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) at Isotime During the Course of the ESWT From Baseline to Week 8|VT is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied. The normal value is approximately 500 mL or 7 mL/kg body weight. The VT of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in VT at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||L||Standard Error|Mean
1416732|NCT01124422|Secondary|Mean Change in Tidal Volume (VT) Per Time Slope During the Course of the ESWT From Baseline to Week 8|VT is the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 mL or 7 mL/kg body weight). VT was measured during the ESWT using the OMS, consisting of volume transducer O2 and CO2 sensors and allowing breath-by-breath measurement of pulmonary gas exchange parameters. The participant's VT per time slope was calculated by fitting a linear regression line (RL) to their VT during the ESWT. VT per time slope results were compared between treatment groups as means of these RLs.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||L/min||Standard Error|Mean
1416733|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) at Isotime During the Course of the ESWT From Baseline to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in RR at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||breaths/min||Standard Error|Mean
1416734|NCT01124422|Secondary|Mean Change in Respiratory Rate (RR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants was measured during the ESWT using the OMS. The system consisted of volume transducer oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The RR per time slope was calculated for each participant by fitting a linear regression line to the RR recorded for each participant during the ESWT. RR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||breaths/min/min||Standard Error|Mean
1416735|NCT01124422|Secondary|Mean Change in Respiratory Exchange Ratio (RER) Per Time Slope During the Course of the ESWT From Baseline to Week 8|The respiratory exchange ratio was calculated as the ratio of VCO2 and VO2. The ratio of the amount of carbon dioxide and oxygen in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. Change from Baseline in RER was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Ratio of VCO2 and VO2||Standard Error|Mean
1416736|NCT01124422|Secondary|Mean Change in Heart Rate (HR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|HR is defined as the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). It was measured during the ESWT using the OMS. The HR was collected in units of bpm and then regressed over the conduct of the exercise test measured in minutes. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the exercise test. HR per time slope results were compared between treatment groups as means of these regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||bpm/min||Standard Error|Mean
1416737|NCT01124422|Secondary|Mean Change in Minute Ventilation (V'E) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'E was measured in the participants during the ESWT using the OMS. The system consisted of a volume transducer, oxygen sensor, and carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'E was collected in liters and then regressed over the conduct of the exercise test measured in minutes. The V'E per time slope was calculated for each participant by fitting a linear regression line to the V'E recorded for each participant during the ESWT. V'E per time slope results were compared between treatment groups as means of the regression lines.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Liter (L)/min||Standard Error|Mean
1416738|NCT01124422|Secondary|Mean Change in Flow of Carbon Dioxide (V'CO2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The amount of CO2 in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of a carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'CO2 per time slope was calculated for each participant by fitting a linear regression line to the V'CO2 recorded for each participant during the ESWT. V'CO2 per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in V'CO2 per time slope was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL/min||Standard Error|Mean
1416739|NCT01124422|Secondary|Mean Change in Flow of Oxygen (V'O2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8|The V'O2 was measured during the ESWT using the Oxycon Mobile System (OMS), a portable telemetric monitoring system consisting of an oxygen sensor allowing for breath-by-breath measurement of gas exchange parameters in the lungs. The V'O2 was collected in units of mL and then regressed over the conduct of the exercise test measured in minutes. The V'O2 per time slope was calculated for each participant (par.) by fitting a linear regression line to the V'O2 recorded for each par. during the ESWT. V'O2 per time slope results were compared between treatment groups as means of these regression lin|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL/minute (min)||Standard Error|Mean
1416740|NCT01124422|Secondary|Mean Change in Exercise Inspiratory Capacity (EIC) at the End of Exercise From Baseline (Week 3) to Week 8|EIC is the volume of gas that can be taken into the lungs in a full inhalation during exercise. Participants were asked to undergo the IC test every 2 minutes during exercise and at the end of the exercise, to follow changes in operational lung volumes that occured in association with exercise. Change from Baseline in EIC was calculated as the value at the end of exercise at Week 8 minus the value at the end of exercise at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||mL||Standard Error|Mean
1419236|NCT01105754|Primary|Symptom Free Days|The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.|2 month follow-up assessment||||Days||Standard Deviation|Mean
1416741|NCT01124422|Secondary|Mean Change in Pre-dose and Post-dose Resting Inspiratory Capacity (IC) From Baseline (Week 4) to Week 8|Resting IC is the volume of gas that can be taken into the lungs in a full inhalation at the resting position. The resting IC was measured before and after dosing. Change from Baseline in pre-dose resting IC was calculated as the pre-dose value at Week 8 minus the pre-dose value at Week 4. Change from Baseline in post-dose resting IC was calculated as the post-dose value at Week 8 minus the pre-dose value at Week 4.|Baseline (Week 4) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Milliliters (mL)||Standard Error|Mean
1416742|NCT01124422|Secondary|Mean Change in EDS at Isotime From Baseline (Week 3) to Week 8|EDS at isotime (last common time point for an exercise assessment [i.e., last Borg score time point of the shortest exercise test for each participant]) was assessed using a 10-point modified Borg scale. Change from Baseline in EDS at isotime was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||Standard Error|Mean
1416743|NCT01124422|Secondary|Mean Change in Scores on the Exercise Dyspnea Scale (EDS) From Baseline (Week 3) to Week 8|EDS is used to measure the level of breathlessness due to exercise, assessed using a 10-point modified Borg scale at 2-minute intervals during the ESWT: 0=no difficulty in breathing at all, 10=maximal breathing difficulty (BD). The participant pointed to the level on the scale correlating with his BD, and the local study coordinator confirmed that level verbally to him. Change from Baseline was calculated as the value at Week 8 minus the value at Baseline. A dyspnea score/time slope was calculated by fitting a linear regression line to the dyspnea scores reported during the exercise tests.|Baseline (Week 3) and Week 8|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale/minute||Standard Error|Mean
1416744|NCT01124422|Primary|Mean Change in Exercise Endurance Time (EET) From Baseline (Week 3) to Week 8|EET is defined as the time taken by a participant to exert himself during an exercise. EET was calculated based on the Endurance Shuttle Walk test (ESWT). The ESWT is a standardized, externally controlled, constant-paced field test for the assessment of endurance capacity in participants with chronic lung disease. Change from Baseline in EET was calculated as the value at Week 8 minus the value at Baseline.|Baseline (Week 3) and Week 8|Intent-to-Treat (ITT) Population: all participants randomized to study drug. Only those participants contributing data at the indicated time points were analyzed.|||Seconds (sec)||Standard Error|Mean
1416745|NCT01124370|Secondary|NYHA Functional Class Improvement From Baseline to 6 Months|"Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.~NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.~NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases."|Baseline and 6 months on therapy|Heart failure subjects with 6 month data.|||participants|||Number
1416746|NCT01124370|Secondary|Six-minute Hall Walk Test Change From Baseline at 6 Months|Change = Month 6 score - Baseline score|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.|||meters||Standard Deviation|Mean
1416747|NCT01124370|Secondary|Heart Failure Clinical Composite|"The composite is determined according to the following definitions.~Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF.~Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward.~Unchanged: patient was neither improved nor worsened."|6 months on therapy|Evaluable subjects with heart failure at baseline.|||participants|||Number
1416748|NCT01124370|Secondary|Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months|Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life.|Baseline and 6 months on therapy|Heart failure subjects with baseline and 6 month results.|||units on a scale||Standard Deviation|Mean
1416749|NCT01124370|Secondary|Epworth Sleepiness Scale Change From Baseline at 6 Months|Change = Month 6 score - Baseline score The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.|Baseline and 6 months on therapy|Subjects with baseline and 6 month data.|||units on a scale||Standard Deviation|Mean
1416750|NCT01124370|Secondary|Related Adverse Events|The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.|Up to 2 years|Subjects with an implant attempt.|||participants|||Number
1416751|NCT01124370|Primary|AHI Change From Baseline at 3 Months|Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.|Baseline and 3 months on therapy|The evaluable population includes subjects who completed a 3 Month post therapy initiation visit.|||events/hour||Standard Deviation|Mean
1416752|NCT01124305|Secondary|Limb Alignment (Mechanical Axis)|"Alignment is measured on 4 month postoperative radiograph in degrees. The goal is a mechanical axis between and femur and tibia of 0 degrees. Varus alignment (bow-legged) is shown as a negative number in degrees away from 0. Valgus alignment (Knock-kneed) is expressed as a positive number in degrees away from 0."|4 months|All participants were x-rayed postoperatively to measure the mechanical axis of the leg in degrees.|||degrees varus(-) or valgus(+)||Full Range|Mean
1416754|NCT01124305|Secondary|Length of Each Surgical Step (in Seconds)|surgical exposure, tibial alignment and resection, femoral distal cut, extension gap balancing, sizing the femur, 4 finishing femoral cuts, posterior releases, patellar resection, trial components, tibial tray preparation, cleanup/ prep for cement, cementing femur, cementing tibia, cementing patella, and closure|1 day|per protocol|||seconds||Standard Deviation|Mean
1416755|NCT01124305|Primary|Length of Surgery|Time elapsed from skin incision to wound closure (in seconds)|1 day|per protocol|||seconds||Standard Deviation|Mean
1416756|NCT01124292|Primary|Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.|Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective|24 months||||scores on a scale||Standard Deviation|Mean
1416757|NCT01124292|Primary|Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting.~Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
1416758|NCT01124292|Primary|Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)|"Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored “CALL” button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance.~Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
1416759|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.~Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.~Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.~Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.~Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months||||Navigation Errors||Standard Deviation|Mean
1416760|NCT01124292|Primary|Driving a Wheelchair Using TDS vs SnP (Completion Time)|"An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.~Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.~Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.~Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.~Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
1416761|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||pixel^2/1000||Standard Deviation|Mean
1416762|NCT01124292|Primary|On-screen Maze Using TDS, Keypad, and SnP (Completion Time)|"Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
1416787|NCT01124162|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1416763|NCT01124292|Primary|Information Transfer Rate (Percentage of Correctly Completed Commands)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months||||Percentage of correctly completed cmd(%)||Standard Deviation|Mean
1416764|NCT01124292|Primary|Information Transfer Rate (ITR)|Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.|24 months||||bits per minute||Standard Deviation|Mean
1416765|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
1416766|NCT01124292|Primary|Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
1416767|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||seconds||Standard Deviation|Mean
1416768|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
1416769|NCT01124292|Primary|Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
1416770|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
1419237|NCT01105702|Secondary|Number of Patients With Grade 3 or 4 Adverse Events|Adverse events evaluated per CTCAE 3|The whole time while on treatment and 30 days after the treatment|all the patients with treatment|||participants|||Number
1416771|NCT01124292|Primary|Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
1416772|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.~Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||Percentage of Missed Targets (%)||Standard Deviation|Mean
1416773|NCT01124292|Primary|Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)|"Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is bits per second.~The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks."|24 months||||bits per second||Standard Deviation|Mean
1416774|NCT01124188|Secondary|Changes in Short Physical Performance Battery From Ph 2 Baseline Till 14 Weeks|"Change in SPPB scores from randomization to 14 weeks for both arms.~The Short Physical Performance Battery (SPPB) assesses physical performance. The SPPB scores range from 0-12 and assess lower extremity strength, balance, and gait speed, three meaningful predictors of morbidity and mortality in late-life. Lower scores on the SPPB indicates greater limitations. Improvement of 0.5 points indicate clinically meaningful improvement in physical performance"|Baseline and 14 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1416775|NCT01124188|Secondary|Change in Roland Morris Disability Questionnaire (RMDQ) From P2 Baseline to 14 Weeks|"Change in RMDQ from randomization to 14 weeks. The Roland-Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability).~Improvement of 30% is clinically meaningful"|Baseline and 14 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1416776|NCT01124188|Primary|Proportion Responding Initially by Treatment Arm During 14 Weeks Post Randomization|The PHQ-9 depression questionnaire scores range from 0 to 27. The higher the score the more severe the depression. A PHQ-9 score less than or equal to 5 represents absence of depression. The Numeric Rating scale is a self report pain scale ranging from 0 to 20. Higher numbers indicate more pain. Response in this study was defined as two consecutive PHQ-9 scores < or = to 5 AND Numeric Rating Scale for pain (NRS) > or = 30% reduction from study entry.|14 weeks||||Participants|||Count of Participants
1416777|NCT01124175|Secondary|AUC0-inf or Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1416778|NCT01124175|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1416779|NCT01124175|Secondary|Cmax of Losartan Carboxy Acid (Maximum Observed Concentration of Drug Substance in Plasma)|Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1416780|NCT01124175|Primary|AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on Losartan AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.|||ng*h/mL||Standard Deviation|Mean
1416781|NCT01124175|Primary|AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on Losartan AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.|||ng*h/mL||Standard Deviation|Mean
1416782|NCT01124175|Primary|Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Losartan Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed. However, one subject had a baseline concentration greater than 5% of Cmax and therefore was not included in the analysis.|||ng/mL||Standard Deviation|Mean
1416783|NCT01124162|Secondary|AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)|Informational comparison of AUC0-inf values for the metabolite Losaran Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1416784|NCT01124162|Secondary|AUC0-t of Losartan Carboxy Acid (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1416789|NCT01124149|Secondary|Percentage of Subjects in Partial Remission at Week 8 of Acute Phase|"Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
1416790|NCT01124149|Secondary|Percentage of Subjects in Complete Remission at Week 8 of Acute Phase|"Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|8 Weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
1416791|NCT01124149|Secondary|Improvement in Stool Frequency Symptoms During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point.~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
1416792|NCT01124149|Secondary|Improvement in Rectal Bleeding Score During the Acute Phase|"Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point.~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood)."|3 and 8 weeks|Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.|||percentage of subjects|||Number
1416793|NCT01124149|Secondary|Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase|"Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
1416794|NCT01124149|Secondary|Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase|Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
1416795|NCT01124149|Secondary|Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase|"Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency.~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
1416796|NCT01124149|Primary|Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase|"Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline.~The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.~Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).~Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).~Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day)."|12 months|Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.|||percentage of subjects|||Number
1416797|NCT01124097|Primary|Change From Baseline to Endpoint in Mean Pain|"The efficacy analysis was restricted to the primary efficacy variable in the analysis population. The intended treatment period, starting on the day of the randomization and ending at the efficacy cut-off date (October 31, 2011), was the basis for the analysis.~The primary efficacy variable was the difference between the mean values of 7 daily pain scores preceding the efficacy cut-off date (endpoint mean pain score), and before randomization (baseline mean pain score), respectively. The daily pain scores were based on the morning response to the 11-point Numeric Rating Pain Scale (NRPS) question relating to average pain intensity over the last 24 hours. The NPRS is an 11-point scale from 0-10 [“0” = no pain; “10” = the most intense pain imaginable]"|baseline to endpoint|efficacy population|||units on a scale||Standard Error|Least Squares Mean
1416838|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|6 weeks from initial injection of corticosteroid versus platelet rich plasma||||units on a scale||Standard Deviation|Mean
1416798|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Lacrimation|Lacrimation was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Excessive lacrimation (tear production and secretion, 1-3) is a symptom of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416799|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Photophobia|Photophobia was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Photophobia (abnormal intolerance to visual perception of light) is a symptom of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416800|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Wound Integrity|Wound integrity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of wound integrity (healing, 1-3) is a sign of inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416801|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Vitritis|Vitritis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Vitritis (accumulation of inflammatory cells or exudates in the vitreous humor, the fluid that fills the middle chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416802|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Hypopyon|Hypopyon was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Hypopyon (pus in the anterior chamber of the eye) is a sign of ocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416803|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Chemosis|Chemosis was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Chemosis (swelling of the conjunctiva) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416804|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Ciliary/Limbal Injection|Ciliary/limbal injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Ciliary/limbal injection (redness of the white sclera of the eye near the limbal ring) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416805|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Conjunctival Injection|Conjunctival injection was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Conjunctival injection (redness of the white sclera of the eye) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416806|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Corneal Clarity|Corneal clarity was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Lack of corneal clarity (1-3) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416807|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Flare Grade|Anterior chamber flare was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 4-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416808|NCT01124045|Secondary|Global Assessment of Inflammation - Individual Component Scoring by Visit: Anterior Chamber Cell Grade|Anterior chamber cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient had missing anterior cell grade assessment at all visits.|||Percentage of patients|||Number
1416809|NCT01124045|Secondary|Global Assessment Score of Postoperative Inflammation by Visit|A Global Assessment Score (GAS) was assigned by the Investigator based on the clinical evidence of postoperative inflammation: 0=clear, 1=improving satisfactorily; 2=not improving or worsening, withdrawal from study indicated to allow appropriate alternative therapy to be instituted. A score of 0 indicates an absence of inflammation. For this outcome measure, percentage of patients by grade and visit is reported.|Day 1, Day 8 ± 1 day, Day 15 ± 2 days, Day 29 ± 2 days, 1 Week after Last Dose + 2 days, 3 Months + 1 week|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication.|||Percentage of patients|||Number
1416810|NCT01124045|Primary|Percentage of Patients With an Anterior Cell Grade of 0 (no Cells) at Day 15 ± 2 Days|Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.|Day 15 ± 2 days|Intent-to-treat (ITT): All patients who received at least 1 dose of study medication. One patient (DUREZOL) had missing anterior cell grade assessment at all visits.|||Percentage of patients|||Number
1416811|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.|12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
1416812|NCT01124006|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.|Safety Population|||participants|||Number
1416813|NCT01124006|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the MCS, SF-36 at Baseline."|||units on a scale||Standard Deviation|Mean
1416814|NCT01124006|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component- PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health)|12 months|"FAS Population~One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the PCS, SF-36 at Baseline."|||units on a scale||Standard Deviation|Mean
1416815|NCT01124006|Secondary|Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.|The Visual Analogue Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line ( that is approximately 10cm long) with 'No Pain' (score of 0=0cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
1416816|NCT01124006|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12-month|FAS Population|||units on a scale||Standard Deviation|Mean
1416817|NCT01124006|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|"Safety Population~For the Neurological Assessment at 12 months, only 8 subjects from the rhGDF-5 1.0mg group (out of 10 subjects total) completed the assessment, only 3 subjects from the rhGDF-5 2.0mg group (out of 4 subjects total) completed the assessment, and none of the placebo subjects (out of 10 total subjects) completed the assessment."|||participants|||Number
1416818|NCT01123980|Secondary|Number of Hypoglycaemic Episodes|All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).|||episodes|||Number
1416839|NCT01123850|Secondary|Outcome Measure - Pain, Life Quality, Satisfaction||PreOp, Surgery, 6M, 12M|Study was terminated due to slow enrollment, there was no data analysis||||||
1416819|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - Severe and Minor|Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L.|Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).|||episodes|||Number
1416820|NCT01123980|Secondary|Number of Hypoglycaemic Episodes - All||Weeks 0-24|The safety analysis set contains all subjects exposed to at least one dose of investigational product(s).|||episodes|||Number
1416821|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage (%) of subjects|||Number
1416822|NCT01123980|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%|The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||percentage (%) of subjects|||Number
1416823|NCT01123980|Secondary|9-point Plasma Glucose Profiles|Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day.|Week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of the trial product(s).|||mmol/L||Standard Error|Mean
1416824|NCT01123980|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 24|Full analysis set using LOCF (last observation carried forward) consists of all randomised subjects who were exposed to at least one dose of trial product(s)|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1416825|NCT01123941|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 6-month period after vaccination||||participants|||Number
1416826|NCT01123941|Primary|Number of Subjects Reporting Adverse Events||During the 28-day period after vaccination||||participants|||Number
1416827|NCT01123941|Secondary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
1416828|NCT01123941|Primary|Number of Subjects Reporting Any Post Immunization Reactions|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.|During the 7-day period after vaccination||||participants|||Number
1416829|NCT01123928|Secondary|"Belief That Doctors and Nurses at the Hospital Have Very Good Attitudes"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
1416830|NCT01123928|Secondary|"Belief That Surgeons at the Hospital Are Highly Skilled"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
1416831|NCT01123928|Secondary|"Belief That Vision Will Improve a Lot Following Surgery"|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
1416832|NCT01123928|Secondary|Belief That Surgery Will be Painful|Measured as a percentage of subjects who agree with the statement in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
1416833|NCT01123928|Secondary|Knowledge That Cataract Can be Treated|Measured as a percentage of subjects who correctly answer the question in a questionnaire.|Assessed during day of screening examination|Analysis was conducted for all participants who responded to this question in the survey.|||percentage of respondents|||Number
1416834|NCT01123928|Secondary|Attendance at Hospital for Pre-operative Examination|Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.|||percentage of participants|||Number
1416835|NCT01123928|Primary|Decision to Undergo Cataract Surgery (Surgery Acceptance)|Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.|within 6 months after screening examination|All participants who completed the study were analyzed.|||percentage of participants|||Number
1416836|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|15 minutes prior to initial injection of corticosteroid versus platelet rich plasma||||units on a scale||Standard Deviation|Mean
1416837|NCT01123889|Primary|Pain and Disability of the Shoulder Through Validated Questionnaires|Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.|12 weeks from initial injection of corticosteroid versus platelet rich plasma||||units on a scale||Standard Deviation|Mean
1416840|NCT01123850|Primary|Fusion Assessment|Fusion at 12M using radiograph Fusion Mass at 12M using CT|6 M, 12 M|Study was terminated due to slow enrollment, there was no data analysis||||||
1416842|NCT01123642|Secondary|Quality of Life Scale (QLS)|Quality of life measure of functioning scored on a 1 (delighted) to 7 (terrible) scale. Scores are summed with higher scores indicating lower quality of life. Total scores range from 16 - 112.|one year|Sample sizes differ due to attrition and missing data.|||score on a scale||Standard Deviation|Mean
1416843|NCT01123642|Secondary|Inventory of Psychosocial Functioning (IPF)|"80-item self-report measure of psychosocial functioning across multiple domains (e.g., family, social, day-to-day activities). Items are rated on a 7-point scale ranging from 0 (never) to 6 (always). Lower scores indicate more positive outcomes."|one year|Sample sizes differ due to attrition and missing data.|||score on a scale||Standard Deviation|Mean
1416844|NCT01123642|Primary|World Health Organization Disability Assessment Schedule II (WHODAS II)|Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.|one year|A total of 345 participants were enrolled, of which 309 were deemed eligible. Analyses are conducted with the total sample N = 309, followed over time. Sample sizes vary over time due to attrition and missing data.|||units on a scale||Standard Deviation|Mean
1416845|NCT01123512|Primary|Proportion of Participants With Study Success|"Patient success will be defined as:~Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),~Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and~Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation"|12 Month Post-op||||participants|||Number
1416846|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
1416847|NCT01123395|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC (0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
1416848|NCT01123395|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys® reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration|Plasma concentration data for 15 of 16 participants were used in the statistical analysis. One subject dropped from the study before Period II dosing for personal reasons.|||ng/mL||Standard Deviation|Mean
1416849|NCT01123382|Secondary|Delay in Termination of Shoulder Abduction EMG Activity|Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials. Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart. The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction. Delay of termination (DOT) was defined as the duration between cessation of the audible tone and return of the EMG signal to baseline. Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation, and return to steady for delay of termination. The mean DOT of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOT were used as summary metrics.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||ratio of affected to unaffected arm||Standard Error|Least Squares Mean
1416850|NCT01123382|Secondary|Delay in Initiation of Shoulder Abduction EMG Activity|Electromyographic activity from the deltoid was also measured during the isometric abduction moment trials. Surface EMG recording electrodes (2 cm x 2 cm) were placed over the deltoid muscle and spaced approximately 4 cm apart. The EMG amplifier gain was adjusted to record as high-fidelity an EMG signal as possible during shoulder abduction. Delay of initiation (DOI) was defined as the duration between onset of the audibe tone and the onset of EMG signal. Raw EMG signals were analyzed visually to determine the earliest rise in EMG activity relative to steady state for delay of initiation. The mean DOI of the three trials were calculated, and the ratio of the paretic to non-paretic shoulder DOI were used as summary metrics.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||ratio of affected to unaffected arm||Standard Error|Least Squares Mean
1416851|NCT01123382|Secondary|Isometric Shoulder Abduction Moment, Ratio Affected to Unaffected|A measure of isometric strength in response to audio cue. Isometric shoulder abduction moment was measured with a Biodex Biomechanical Measurement System (Biodex Medical Systems, Shirley, NY). The average moment during the last second of the audible tone was calculated for each trial and those values were averaged over the three trials. Subjects underwent testing of both shoulders, non-paretic side first, and the results are presented as the ratio of the paretic shoulder to the non-paretic shoulder to decrease the influence of intra-subject variability between measurements.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||ratio of affected to unaffected arm||Standard Error|Least Squares Mean
1416852|NCT01123382|Secondary|Pain Interference Questionnaire|BPI-9 from Brief Pain Inventory, Short Form. Pain interference is on a 0 - 10 scale, with 0 being no interference, and 10 being complete interference.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
1416853|NCT01123382|Secondary|Fugl-Myer Motor Assessment (FMA) - Upper Extremity|The Fugl-Myer Motor Assessment (FMA) is a motor recovery measure. Volitional movement of the upper limb (shoulder, elbow, forearm, wrist, and hand) is examined in and out of synergies. Each item was graded on a 3-point ordinal scale and summed to provide a maximum score of 66, with higher scores indicating lower impairment.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
1416854|NCT01123382|Secondary|Pain-free External ROM, Degrees|Passive pain-free Externa ROM is a motor recovery measure. The subject was supine with the shoulder adducted with hand resting on the abdomen, elbow flexed, and with the humerus supported by the mat. The axis of a universal goniometer was centered on the olecranon process of the ulna projecting through the humeral shaft toward the humeral head. The subject’s shoulder was externally rotated passively to the pain threshold, defined as the start of any pain. Pain at rest was recorded as 0 degrees.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||degrees||Standard Error|Least Squares Mean
1416855|NCT01123382|Secondary|SF-36 Bodily Pain Component|The SF-36v2 is a population-norm based health related quality of life measure, presented in T-scores where population average equals a score of 50 with a standard deviation of 10. Maximum is 100, with higher score indicating greater health realated quality of life.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
1416856|NCT01123382|Secondary|ShoulderQ VGRS Scale|The ShoulderQ Visual Graphics Rating Scale (VGRS) T is a structured questionnaire designed to assess severity of HSP at rest during the day, on movement, and at night on a 0-30 scale where higher numbers indicate greater pain.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
1416857|NCT01123382|Primary|Brief Pain Inventory Short Form|The BPI is a pain questionnaire, which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.|Baseline (Week 0); Start of Treatment (Week 1); End of Treatment (EOT, Week 4); EOT + 6 wks (Week 10); EOT + 12 wks (Week 16)||||units on a scale||Standard Error|Least Squares Mean
1416858|NCT01123356|Secondary|Dose Reductions Due to Adverse Events.|Number of dose reductions due to toxicity.|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.|||dose reductions|||Number
1416859|NCT01123356|Secondary|Frequency of Adverse Events|Number of adverse events occuring in greater than 20% of subjects|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.|||events|||Number
1416860|NCT01123356|Secondary|Biomarkers Changes During Treatment.|Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.|30 Weeks|The biomarker sub-study was not completed due to poor accrual to this substudy and lack of feasibility.||||||
1416861|NCT01123356|Secondary|Frequency of Adverse and Severe Adverse Events|Frequency of adverse and severe adverse events|30 weeks|Adverse Events were assessed at each treatment visit. All patients who were treated are included in the adverse event analysis.|||participants|||Number
1416862|NCT01123356|Primary|Overall Response Rate|"Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).~Overall response rate was defined as those who experienced a response of CR, CRi or PR."|30 Weeks|Overall response rate is defined as response (CR, CRi or PR) at cycle 3 or cycle 6 evaluation. Only patients who completed at least 3 cycles were eligible for analysis for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1416863|NCT01123200|Secondary|Changes in Accuracy of BCI for Controlling Devices and Text|Changes in Accuracy Percentage (i.e., cumulative correct selections per month divided by the cumulative number of intended sections per month). Looking for trends over each 6 month period.|6 months, 12 months, 18 months|The first six month period was not completed by any participant so accuracy data for six months could not be analyzed.||||||
1416864|NCT01123200|Primary|Duration of BCI Usage by Persons With ALS.|Number of months of BCI usage by each participant.|Monthly measurements for a period of up to 18 months.||||months||Full Range|Mean
1416865|NCT01123161|Secondary|NIHSS Scores at 90 Days|The National Institutes of Health Stroke Scale (NIHSS) is used to quantify neurological deficit. The scale ranges from 0 (best) to 42 points (worst). Between scores of 0 to 42, higher values reflect progressively greater deficit.|90 days|Intention to treat patients with an available 90-day NIHSS values therefore the total numbers available are fewer than the total ITT population.|||units on a scale||Standard Deviation|Mean
1416866|NCT01123161|Secondary|The Barthel Index Measure of Activities of Daily Living;|The Barthel index measures independence in activities of daily living from 0 (worst) to 100 (best) in 5 point increments. Higher scores between 0 and 100 reflect progressively greater levels of independence. Scores were dichotomized at 90 so that a score of 95 or 100 was considered a successful treatment.|90 days|The intention to treat population with a 90-day Barthel index available was used, therefore the numbers are fewer than in the total population.|||participants|||Number
1416867|NCT01123161|Primary|90 Day Mortality|Mortality prior to the 90-day evaluation.|90 days|ITT population|||participants|||Number
1416868|NCT01123161|Primary|Incidence of Pneumonia|Number subjects diagnosed with pneumonia according to CDC criteria will be presented by treatment group and overall, regardless of seriousness|7 days or discharge whichever comes first|ITT population|||participants|||Number
1417405|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 4||||participants|||Number
1416869|NCT01123161|Primary|Incidence of Any Symptomatic Intracranial Hemorrhage (sICH) Within 48 Hours of Stroke Onset|Incidence (number) of Symptomatic ICH (sICH) within 48 hours of stroke onset will be presented by treatment group and overall. Patients with neuroworsening (4 or more point increase in NIHSS , or a decline in the NIHSS consciousness item 1A score of more than 1 point, or a motor deterioration lasting more than 8 hours, all not due to iatrogenic cause) and hemorrhage seen on brain images in whom the investigator attributes the clinical change to the hemorrhage.|48 hours|ITT patients in whom a brain image was obtained 36 yo 48 hours after treatment|||participants|||Number
1416870|NCT01123161|Primary|Incidence of Any Intracranial Hemorrhage (ICH) Within 48 Hours of Stroke Onset|Incidence (number) of any intracranial hemorrhage (ICH) (whether or not symptomatic) within 48 hours of stroke onset will be presented by treatment group and overall.|48 hours|Intention to treat patients with imaging obtained 36 to 48 hours after treatment|||participants|||Number
1416871|NCT01123161|Primary|The Primary Outcome is the Proportion of Patients Achieving a Favorable Outcome Defined as Modified Rankin Scale Score of 0 or 1, Assessed 90 Days After Treatment.|Modified Rankin describes disability: 0 is free of any disability or symptoms, 6 is death, and higher grades between 0 and 6 reflect progressively greater disability|90 days|Intention to Treat Population|||participants|||Number
1416872|NCT01123148|Primary|The Accuracy of BCI Typing While Tilting in a Power Wheelchair and While Sitting Still in a Power Wheelchair.|"Subjects will participate in 3 sessions. During each session each subject will copy a word in each of 3 conditions (no-movement, self-movement, continuous movement) by typing using only brainwaves. For the no-movement condition, the wheelchair seat remains in a fixed position. For the self-movement condition, the angle of the wheelchair seat changes in response to some of the selections made with the brain-computer interface. For the continuous movement condition, the angle of the wheelchair seat moves continuously. Changes in the wheelchair's position may affect spelling accuracy. The accuracy of the subject's copy spelling of the designated word will be measured for each condition in each session. The order of the conditions is balanced across the three days. The accuracy for each subject in each condition is presented as the average of the accuracies for that condition across the three days."|3 1-2 hour sessions over 2-4 weeks||||% Accuracy of selections||Standard Deviation|Mean
1416873|NCT01123083|Secondary|Composite Rank Sum: C-Peptide AUC, HbA1c and Exogenous Insulin Use at 6 and 12 Months|O'Brien analyses was performed on a three-part composite of HbA1c level, C-peptide AUC, and mean daily insulin use in the otelixizumab group compared with the placebo group at Months 6 and 12. The three variables was adjusted for Baseline values. Baseline adjustment was used to reduce the potential impact of imbalances in Baseline levels between treatment groups on the treatment comparisons at later time points. HbA1c and insulin use was ranked from smallest to largest, and C-peptide AUC was ranked from largest to smallest. If otelixizumab treatment was effective on the composite endpoint, then the mean of the ranks sum in the otelixizumab group was smaller than the mean of the ranks sum in the placebo group.|Month 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Rank||Standard Deviation|Mean
1416874|NCT01123083|Secondary|Composite Rank Sum: HbA1c and Exogenous Insulin Use at 6 and 12 Months|O'Brien mean rank analyses was performed on a two-part composite of the Baseline-adjusted HbA1c level and the Baseline-adjusted mean total daily insulin use per kg body weight in the otelixizumab group compared with the placebo group at Months 6 and 12. Baseline adjustment was used to reduce the potential impact of imbalances in Baseline levels between treatment groups on the treatment comparisons at later time points. For the O'Brien mean rank analysis at a particular time point, adjusted HbA1c values (for both treatment groups together) and adjusted mean daily insulin use values was ranked from smallest to largest. For each participant, the HbA1c and insulin use ranks were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks. If otelixizumab treatment was effective on this composite endpoint, then the mean of the ranks sum in the otelixizumab group was smaller than the mean of the ranks sum in the placebo group.|Month 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Rank||Standard Deviation|Mean
1416875|NCT01123083|Secondary|Percentage of Participants With Change From Baseline in Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events at Month 12|Severe hypoglycemia was considered as an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was considered as an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration less than or equal to 70 mg/dL and it was collected in (1) eCRF using two forms – for single event and for mutiple events, and (2) the IVRS system. The percentage of participant with incidence of severe hypoglycemia and documented symptomatic hypoglycemia have been reported.|Baseline (Day 1) and Month 12|ITT population.|||Percentage of participants|||Number
1416876|NCT01123083|Secondary|Average Number of Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events From Baseline to Month 12|Severe hypoglycemia was considered as an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was considered as an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration less than or equal to 70 mg/dL and it was collected in (1) eCRF using two forms – for single event and for mutiple events, and (2) the IVRS system. The numbers of participant-reported hypoglycemic events per participant of severe hypoglycemia and documented symptomatic hypoglycemia have been reported.|Baseline (Day 1) and Month 12|ITT population.|||Events|||Number
1416877|NCT01123083|Secondary|Change From Baseline in HbA1c Levels Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment|HbA1c level was recorded at Baseline, Month 3, 6 and 12. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Month 3, 6, 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Percentage of HbA1c||Standard Error|Least Squares Mean
1416878|NCT01123083|Secondary|Change From Baseline in Mean Daily Insulin Use Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment|Mean daily insulin use over 7 consecutive days during the 2 weeks preceding each key visit was calculated as the mean of the values of amount of insulin used per day on each of the 7 consecutive days. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Month 3, 6, 12|ITT population. Only those participants available at the indicated time points were analyzed.|||International unit per kilogram (IU/kg)||Standard Error|Least Squares Mean
1416879|NCT01123083|Secondary|Number of Participants With Responder Status|A participant was considered a responder when, at the given time point, the participant had: glycosylated hemoglobin (HbA1c) less than or equal to 6.5 percent and mean daily insulin use less than 0.5 international unit per kilogram per day (IU/kg/day) over 7 consecutive days during the 2 weeks preceding the visit.|Month 3, 6 and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1416880|NCT01123083|Secondary|Change From Baseline in Stimulated C-Peptide Mean AUC at Week 12, Month 6, 12 and 18|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg/dL and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Week 12, Month 6, 12, 18|ITT population. Only those participants available at the indicated time points were analyzed.|||nanomoles per liter||Standard Deviation|Mean
1416881|NCT01123083|Secondary|Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide AUC (Normalized for 120-minute Time Interval) at Week 12 and 6 Months|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg/dL and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post Baseline value from the Baseline value.|Baseline (Day 1) and Week 12, Month 6|ITT population. Only those participants available at the indicated time points were analyzed.|||nanomoles per liter||Standard Error|Least Squares Mean
1416882|NCT01123083|Primary|Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide Area Under Curve (AUC) (Normalized for 120-minute Time Interval) at Month 12|C-peptide is a protein that shows how much insulin the body is producing. For 3 days before the mixed meal tolerance test participants were asked to eat a balanced diet. The test was performed only when the finger-stick blood glucose level was above 70 mg per deciliter (mg/dL) and no higher than 200 mg/dL. Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from time 0 to 120-minutes, calculated using the trapezoidal rule. This AUC was normalized for time interval by dividing it by 120-minutes (the number of minutes over which it was determined), and was adjusted by inclusion of Baseline C-peptide AUC as a covariate in the analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the value at Month 12 from the Baseline value.|Baseline (Day 1) and Month 12|ITT population consisted of all participants who were randomized and received any part of at least 1 infusion of study drug. Only those participants available at the indicated time points were analyzed.|||nanomoles per liter||Standard Error|Least Squares Mean
1416883|NCT01122927|Secondary|Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)|The CGAS is a 100-point rating scale measuring psychological, social, and school functioning for children aged 6 to 17. It was adapted from the Adults Global Assessment Scale. The Global Assessment Scale was a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS Score (range 1 to 100) is a single-item score for rating a child’s general level of functioning on a health-illness continuum, with higher scores representing better functioning.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416884|NCT01122927|Secondary|Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score|The ADHD-RS-IV is a reliable and easy-to-administer instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. Containing 18 items, the scale was linked directly to DSM-IV-TR diagnostic criteria for ADHD. There were 3 versions of the scale: a parent questionnaire on home behaviors (English), a parent questionnaire on home behaviors (Spanish), and a teacher questionnaire on classroom behaviors. For this trial, the parent questionnaire on home behaviors (English) was utilized. The ADHD-RS-IV Total Score (range 0 to 54) is the sum of rating scores for 18 items, with higher scores representing greater severity. A missing value for any ADHD-RS-IV assessment items could have resulted in a missing ADHD-RS-IV Total Score. Data were only available for 82 participants with bipolar disorder and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416892|NCT01122927|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416885|NCT01122927|Secondary|Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale|The GBI is a self-report inventory with 73 items focusing on mood-related behaviors, including depressive, hypomanic, and biphasic symptoms. For this trial, two 20-item subscales were utilized: one was completed by the parent/guardian or legal representative, as applicable for local laws, and the other was completed by the participant. Responses were given on a 4-point Likert scale, with 0 being never or hardly ever and 3 being very often or almost constantly. The GBI Total Score for mania (range 0 to 30) is the sum of scores for items 1 to 10 and the GBI Total Score for depression (range 0 to 30) is the sum of scores for items 11 to 20 in the GBI Parent/Guardian or Subject Version panel. Scores from the Parent/Guardian and participant Versions were summarized separately. A missing value for any GBI assessment items could have resulted in a missing GBI Total Score. High scores represent greater psychopathology. Data was only available for 80 de novo participants with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416886|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject’s Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Only 94 participants had data at Baseline to explain the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416887|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score|The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject’s Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Data for 94 de novo participants were available with bipolar disorder.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416888|NCT01122927|Secondary|Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score|The YMRS consists of 11 items assessing the core symptoms of mania and was used to assess participants with bipolar I disorder, manic and mixed episodes with or without psychotic features: elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech (rate and amount), language - thought disorder, content, disruptive - aggressive behavior, appearance, and insight. Each item had 5 or 9 grades of severity, with lower scores indicating milder symptoms. The number of raters within each trial center was to be kept to a minimum. The YMRS Total Score (range 0 to 44) is the sum of the rating scores for 11 items for assessing the core symptoms of mania. A missing value for any YMRS assessment item(s) could have resulted in a missing YMRS Total Score. A higher YMRS Total Score represents greater severity. In this study, 94 participants had bipolar disorder, this explains the N=94 in the table below and these were de novo participants.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416889|NCT01122927|Secondary|Mean Change in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416890|NCT01122927|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416891|NCT01122927|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416912|NCT01122901|Primary|Efficiency of Neurosphere Generation After Pretreatment With RO4929097 (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At time of surgery|This outcome could not be analyzed as the n was too small. Only had 7 samples. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug||||||
1416893|NCT01122927|Secondary|Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416894|NCT01122927|Secondary|Percentage of Participants Who Discontinued Due to All Adverse Events|The percentage of participants who discontinued due to all causes other than sponsor terminating the trial was measured from the date of entering the open-label treatment phase to the date of ET for discontinued participants in the open-label treatment phase (ie, time to discontinuation = date of discontinuation [or date of completion for completed participants] − date of participant entering the open-label treatment phase + 1). If the participants completed the trial or were discontinued due to the sponsor terminating the trial, they were censored at the time of completion or trial termination, respectively.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||percentage of participants|||Number
1416895|NCT01122927|Secondary|Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The below reported N value is the number of participants with specified suicidal ideation/behavior at the given time point.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
1416896|NCT01122927|Secondary|Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score|Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416897|NCT01122927|Secondary|Baseline and Post-Baseline Tanner Staging|Tanner staging was completed together with the physical examination by the same trial-affiliated clinician in the most inconspicuous manner for the participant as possible. Tanner staging assessment consisted of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. A participant who reached Stage 5 (both in pubic hair and genitalia) did not need to continue with Tanner Staging assessment and the Tanner Staging scales of this participant were imputed as 5 for all of the following scheduled time points up to and including the completion visit/ET visit. The clinician arrived at a single score summarizing the domains (not individual domain scores) when evaluating the participant. The total shift data for last visit is presented below.|Baseline to Last Visit|All those participants who had received at least one dose of oral aripiprazole during the open-label treatment phase.|||participants|||Number
1416898|NCT01122927|Secondary|Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)|The NY-AACENT is not a validated scale. It was included in this trial because of concerns that regulatory authorities (the European Committee for Medicinal Products for Human Use [CHMP] and the Paediatric Sub-Committee of the European Medicinal Agency [PDCO]) had regarding drug induced cognitive impairment. No validated scale addressing these issues was available at the time of the trial. The NY-AACENT was used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It was specifically designed to be used in pediatric populations (ages 12 to 17), but could have been utilized with other age groups, as appropriate.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
1416899|NCT01122927|Secondary|Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score|The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416900|NCT01122927|Secondary|Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1416901|NCT01122927|Secondary|Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||Units on a scale||Standard Deviation|Mean
1417425|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 4|Change in albumincorrected serum calcium from Baseline to week 4|Baseline and week 4||||mmol/L||Standard Deviation|Mean
1416902|NCT01122927|Secondary|Incidence of Vital Signs of Potential Clinical Relevance|Vital signs are taken at Baseline, Weeks 1, 2, 3, 4, 6, 8, and Months 3, 4, 6, 9, 12, 15, 18, 21, 24 of Phase 2 (Visits beyond Month 12 only for de novo subjects). Assessments included orthostatic (supine and standing) blood pressure (BP), heart rate and body temperature. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Abnormal vital signs in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
1416903|NCT01122927|Secondary|Incidence of Physical Examination Findings of Potential Clinical Relevance|The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole. Any clinically relevant abnormal changes were recorded as TEAEs.|||participants|||Number
1416904|NCT01122927|Secondary|Incidence of Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Baseline to Month 24|All participants who had received at least one dose of oral aripiprazole.|||participants|||Number
1416905|NCT01122927|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.|All participants who had received at least one dose of oral aripiprazole.|||Participants|||Number
1416906|NCT01122901|Secondary|Progression Free Survival|Time to event endpoints for Group A will be measured from the date of first dose. All patients who receive at least one dose of study drug will be included in the analysis. Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment). Progression defined as: >25% increase sum of products of perpendicular diameters (bi-dimensional measurements) of enhancing lesions (over baseline (BL) if no decrease) on stable or increasing doses of corticosteroids. and/or b) Significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared to BL scan or best response following initiation of therapy c) Any new lesion. d) Clear clinical deterioration not attributable to other causes apart from the tumor e) Failure to return for evaluation due to death or deteriorating condition.|2 years||||months||95% Confidence Interval|Median
1416907|NCT01122901|Secondary|Tumor Propagation (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At the time of surgery|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug.||||||
1416908|NCT01122901|Secondary|Expression Levels of Notch Pathway Components and Downstream (Group B)|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug. All CTEP-sponsored trials using RO4929097 were closed to accrual and all patients had to be off treatment by 7/31/12.|At the time of surgery|This outcome could not be analyzed as the n was too small. The study was terminated prematurely by Hoffman-La Roche Company due to their decision to terminate drug supply for further development of this drug.||||||
1416909|NCT01122901|Secondary|Overall Survival|"time to event endpoints for Group A will be measured from date of first dose. All patients who receive at least one dose will be included in analysis.~Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment)."|2 years||||months||95% Confidence Interval|Median
1416910|NCT01122901|Secondary|Number of Participants With Toxicities Associated With Study Drug (Group A and Group B)|assessed by the National Cancer Institute CTCAE version 4.0 assessed if patient received at least one dose of study drug Grade 3-5 toxicities grade 3 -severe grade 4 - life threatening grade 5 - death|Up to 30 days after completion of study treatment||||Participants|||Count of Participants
1416911|NCT01122901|Secondary|Radiographic Response Rate According to the Radiographic Assessment in Neuro-Oncology Criteria (Group A) and Group (B)|"RANO:~Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined.~Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids.~Partial Response (PR): >/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone.~Stable/No Response: Does not qualify for CR, PR, or progression.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|Up to 6 months after completion of treatment||||Participants|||Count of Participants
1416913|NCT01122901|Primary|Overall Median Progression-free Survival (6-month PFS)|Time to event endpoints for Group A will be measured from the date of first dose. All patients who receive at least one dose of study drug will be included in the analysis. Time to event endpoints for Group B will be measured from the first post-surgical date (this will be considered start date of treatment). Progression defined as: >25% increase sum of products of perpendicular diameters (bi-dimensional measurements) of enhancing lesions (over baseline (BL) if no decrease) on stable or increasing doses of corticosteroids. and/or b) Significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared to BL scan or best response following initiation of therapy c) Any new lesion. d) Clear clinical deterioration not attributable to other causes apart from the tumor e) Failure to return for evaluation due to death or deteriorating condition.|At 6 months||||months||95% Confidence Interval|Median
1416914|NCT01122862|Secondary|Interproximal Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
1416915|NCT01122862|Secondary|Interproximal Plaque Index After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
1416916|NCT01122862|Secondary|Plaque Index After 24 Hours of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 1 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
1416917|NCT01122862|Secondary|Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
1416918|NCT01122862|Primary|Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration|Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.|Day 4 post treatment administration|Intention to Treat (ITT) population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.|||Score on a scale||Standard Error|Mean
1416919|NCT01122849|Secondary|Number of Participants Showing Improvement for VAS Scale Daily Diary Questions|Participants were asked following daily diary VAS scale questions a) How easy it was to breathe through your nose and b) How open their nose feels at this time. Both of these questions were scored using 100 mm VAS scale where, 0=extremely difficult, 100=extremely easy.|on first night (Night 1) of each daily diary question|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
1417426|NCT01120223|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8-weeks||||percent subjects|||Number
1416920|NCT01122849|Secondary|Number of Participants Showing Improvement for Daily Diary Questions (Q2 and Q4)|Participants were asked Q2 (How stuffed does your nose feel at this time?) and Q4 (How Breathing felt after the nasal strip was applied) of daily diary questions. Q2 was scored on 4 point scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms and Q4 on 11 point scale where -5=much worse, 0=same, 5=much better.|on first night (Night 1) of each daily diary question|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
1416921|NCT01122849|Secondary|Number of Participants Showing Improvement for Sleep Problems and Symptoms on Waking in the Morning Domain of the NRQLQ|Participants scored all two domains of NRQLQ using same 7 points scale: 0=Not troubled, 1=Hardly troubled, 3=moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Domains were Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score), and Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up); Lower scores indicate improvement in the rhinitis symptoms.|At Day 7 and Day 14||||Participants|||Count of Participants
1416922|NCT01122849|Secondary|Change From Baseline in Mean Average Score of NRQLQ for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7 and Day 14 in Participants With the Risk of Sleep Apnea.|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Day 7 and at Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1416923|NCT01122849|Secondary|Summary of Daily Diary Questions at Bed Time (After Strip Application) and in Morning (After Strip Removal).|Participants were asked how breathing felt after nasal strip was applied at bed time and removed in morning. The participants scored their responses on the scale of -5 to 5 where -5 = much worse, 0 = same and 5= much better. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1416924|NCT01122849|Secondary|Summary of Daily Dairy Questions Before and After Strip Removal in Morning|Participants were asked how stuffed their nose felt before and after strip removal in morning. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily.|At Day 1, Day 2, day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1416925|NCT01122849|Secondary|Summary of Daily Diary Questions Before and After Strip Application at Bedtime|Participants were asked how stuffed their nose felt before and after strip application at bed time. The participants scored their responses on the scale of 0 to 3 where 0=No symptoms, 1=mild symptoms and 3=severe symptoms. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment|||Score on a scale||Standard Deviation|Mean
1416926|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning.|Participants were asked how open their nose feels before and after strip removal in morning. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
1416927|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime|Participants were asked how open their nose feels before and after strip application at bedtime. The participants scored their responses VAS scale where 0 = nose was extremely blocked and 100 = nose was extremely clear. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
1416928|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Removal in Morning|Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1416975|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416929|NCT01122849|Secondary|Summary of Other Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime|Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|At Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 9, Day 10, Day 11, Day 12, and Day 13|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment|||Score on a scale||Standard Deviation|Mean
1416930|NCT01122849|Secondary|Summary for Other Questions of PIRS Questionnaire|The following questions were asked from Section A (Q1 to Q12; 2 Not getting enough sleep, 4 Poor alertness during the daytime, 5 Difficulty keeping your thoughts focused, 6 Others noticing you appeared tired or fatigued, 7 too many difficulties to overcome, 8 Bad moods because you had poor sleep, 9 Lack of energy because of poor sleep, 10 Poor sleep that interferes with your relationships, 11 Being unable to sleep, 12 Being able to do only enough to get by, Section B (Q13 to Q16; 13 From the time you tried to go to sleep, How long did it take to fall asleep on most nights, 14 If you woke during the night, how long did it take to fall back to sleep on most nights,15 Not counting times when you were awake in bed, how many hours of actual sleep did you get during the worst night, 16 On how many days did you have trouble coping because of poor sleep and Section C (Q17 to Q20;, 19 The regularity of your sleep, 20 The soundness of your sleep)|At Day 7 and Day 14||||Score on a Scale||Standard Deviation|Mean
1416931|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 14|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score ona scale||Standard Deviation|Mean
1416932|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) in Morning on Day 7|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2) and how breathing felt after strip was removed (Q4) in morning. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better. (Q4 was asked after strip removal only therefore no data for before removal is available for question 4.)|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1416933|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 14|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2, the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for question 4.)|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1416934|NCT01122849|Primary|Mean Score in Response to Daily Diary Questions (Q2 and Q4) at Bedtime on Day 7|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip application (Q2) and how breathing felt after strip was applied (Q4) at bedtime. For Q2 the participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms. For Q4, participants scored their responses on a scale of -5 to 5 where -5=much worse, 0=same, and 5=much better (Q4 was asked after strip application only therefore no data for before application is available for Q4.)|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
1416935|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 14.|Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0=extremely difficult to breathe and 100=extremely easy|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1416936|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Removal in Morning on Day 7|Participants were asked how easy it was to breathe through their nose before and after strip removal in morning. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
1416937|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 14|Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1419238|NCT01105702|Secondary|Median Overall Survival (OS)|OS defined as time from diagnosis to most recent follow up or death.|Up to 50 months|intent-to-treat population|||months||95% Confidence Interval|Median
1416938|NCT01122849|Primary|Mean Score in Response to Daily Diary VAS Scale Questions Before and After Strip Application at Bedtime on Day 7|Participants were asked how easy it was to breathe through their nose before and after strip application at bedtime. The participants scored their responses on 100 point VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe. These responses were recorded daily.|Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on scale||Standard Deviation|Mean
1416939|NCT01122849|Primary|Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 14|Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lowe CQ7 scores reflect better nasal patency.|At Baseline and Day 14||||Score on a Scale||95% Confidence Interval|Least Squares Mean
1416940|NCT01122849|Primary|Change From Baseline in Mean Sum of 7 Questions of Congestion Quantifier 7 Questionnaire (CQ7) at Day 7|Participants answered following questions of CQ7 questionnaire: Q1 -How often did you have nasal stuffiness, blockage, or congestion?, Q2- How often did you have sinus pressure or pain in your face?, Q3-How often did you have to breathe through your mouth because you could not breathe through your nose?, Q4-How often did you have difficulty completely clearing your nose even after repeated blowing?, Q5-How often did any of these symptoms affect your ability to work, learn in school, or do the things you need to do?, Q6-How often did you awaken in the morning with nasal stuffiness, blockage, or congestion?, Q7-How often was your sleep affected by your nasal stuffiness, blockage, or congestion?. Their responses were scored using a 5 point scale where 0=none of the time; 1=a little of the time, 2=some of the time, 3=most of the time, 4=all of the time. Lower CQ7 scores reflect better nasal patency.|At Baseline and Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1416941|NCT01122849|Primary|Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 14|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Baseline and Day 14|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1416942|NCT01122849|Primary|Change From Baseline in Mean Average Score of NRQLQ (Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) on the) at Day 7|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0-30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes, need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Baseline and Day 7|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1416943|NCT01122849|Primary|Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 14|Participant were asked questions related to their sleep using PIRS questionnaire. The PIRS questionnaire had 3 sections. Section A (Q1 to Q12), Section B (Q13 to Q16) and Section C (Q17 to Q20). Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B questions 13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn’t sleep; Questions 15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn’t sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.|At Baseline and Day 14|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1416976|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416944|NCT01122849|Primary|Change From Baseline in Mean Average Score Using Pittsburgh Insomnia Rating Scale (PIRS) in Q1, Q3, Q17 and Q18 at Day 7|The PIRS questionnaire had 3 sections (Section A [Q1 to Q12], Section B [Q13 to 16] and Section C [Q17 to Q20]). The following questions were asked from Section A : 1. One or more awakenings after getting to sleep and 3 Sleep that does not fully refresh you, and Section C: 17 Your sleep quality compared to most people and 18 Your satisfaction with your sleep. Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely bothered. Section B, Q13 and 14 were scored as follows 0= Less than ½ hour, 1= between ½ to 1 hour, 2= between 1 to 3 hours and 3=more than 3 hours or I didn’t sleep; Q15 and 16 were scored as 0=more than 7 hours, 1= between 4 to 7 hours, 2= between 2 to 4 hours, and 3=Less than 2 hours or I didn’t sleep. Section C questions were scored as follows: 0=Excellent, 1=Good, 2=Fair, and 3=Poor. Lower PIRS score shows better sleep quality.|At Baseline and Day 7|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized and had at least one post-baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1416945|NCT01122680|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and last week of treatment (week 4)|FAS with non-missing data for nighttime awakenings|||Night awakenings per week||Standard Error|Least Squares Mean
1416946|NCT01122680|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of a seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with non-missing ACQ data|||Units on a scale||Standard Error|Least Squares Mean
1416947|NCT01122680|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Day|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing data for rescue medication|||Puffs/day||Standard Error|Least Squares Mean
1416948|NCT01122680|Secondary|Mean Evening PEF Response|Mean evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing evening PEF data|||Litre/min||Standard Error|Least Squares Mean
1416949|NCT01122680|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing morning PEF data|||Litre/min||Standard Error|Least Squares Mean
1416950|NCT01122680|Secondary|Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point|FEF 25-75% is the mean forced expiratory flow between 25% and 75% of the FVC determined at the end of the 4-week treatment period. This is often referred to as the maximum midexpiratory flow. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEF data|||Litre||Standard Error|Least Squares Mean
1416951|NCT01122680|Secondary|FVC Individual Measurements at Each Time-point|"Individual FVC measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
1416952|NCT01122680|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
1416953|NCT01122680|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
1416954|NCT01122680|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FVC data.|||Litre||Standard Error|Least Squares Mean
1416955|NCT01122680|Secondary|FEV1 Individual Measurements Response at Each Time-point|"Individual FEV1 measurements at each time-point (personal best). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model."|Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)|FAS with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
1416956|NCT01122680|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
1416957|NCT01122680|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
1416977|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416958|NCT01122680|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period. This patient set is therefore FAS reduced to patients with non-missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
1416959|NCT01122576|Secondary|Best-corrected Distance Visual Acuity|High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA)|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set|||logMAR|Participants|Standard Deviation|Mean
1416960|NCT01122576|Secondary|Uncorrected Distance Visual Acuity|High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches|Visit 3 (2-3 months) Visit 4 (4-6 months)|Full Analysis Set|||logMAR|Participants|Standard Deviation|Mean
1416961|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 4 (4-6 Months)|Full Analysis Set|||Diopters|Participants|Standard Deviation|Mean
1416962|NCT01122576|Secondary|Manifest Refraction|Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder.|Visit 3 (2-3 Months)|Full Analysis Set|||Diopters|Participants|Standard Deviation|Mean
1416963|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1416964|NCT01122576|Secondary|Binocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1416965|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 4 (4-6 months)|Full Analysis Set|||units on a scale|Participants|Standard Deviation|Mean
1416966|NCT01122576|Secondary|Monocular Halo and Starburst|Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome.|Visit 3 (2-3 months)|Full Analysis Set|||units on a scale|Participants|Standard Deviation|Mean
1416967|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 4 (4-6 months)||||units on a scale|Participants|Standard Deviation|Mean
1416968|NCT01122576|Secondary|Optical Scatter|Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention.|Visit 3 (2-3 months)|Full Analysis Set|||units on a scale|Participants|Standard Deviation|Mean
1416969|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416970|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416971|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416972|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416973|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416974|NCT01122576|Secondary|Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1417485|NCT01120093|Secondary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1416978|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416979|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416980|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416981|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416982|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416983|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416984|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416985|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416986|NCT01122576|Secondary|Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416987|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416988|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416989|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 4 (4-6 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416990|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416991|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416992|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units||Standard Deviation|Mean
1416993|NCT01122576|Secondary|Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Visit 3 (2-3 months)|Full set analysis|||log contrast sensitivity units||Standard Deviation|Mean
1416994|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416995|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416996|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416997|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416998|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 4 ( 4-6 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1416999|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1417000|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1417001|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1417002|NCT01122576|Primary|Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree|Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity|Postoperative visit 3 (2-3 months)|Full analysis set|||log contrast sensitivity units|Participants|Standard Deviation|Mean
1417003|NCT01122511|Secondary|Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
1417004|NCT01122511|Secondary|Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
1417005|NCT01122511|Secondary|The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
1417006|NCT01122511|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|No participants reached the 12 month time-point. Efficacy analyses were not performed.||||||
1424563|NCT01059760|Primary|Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1417007|NCT01122394|Secondary|Antihypertensive/ Lipid-lowering Medication Adherence|Measured by Morisky Medication taking questionnaire (self-reported). Scores range from 0-4, with 0 being least adherent and 4 being most adherent|6 months|One participant in TI did not answer all of the questions on this assessment, so his score could not be computed and therefore he is not included in this analysis|||units on a scale||Standard Deviation|Mean
1417008|NCT01122394|Secondary|Exercise Adherence|Measured by 7-day Physical Activity Recall|6 months||||hours per week of cardio||Inter-Quartile Range|Median
1417009|NCT01122394|Secondary|Total Cholesterol/High Density Lipoprotein Ratio||6 months|Only participants who provided a blood sample for which cholesterol could be analyzed were included in this analysis|||ratio||Inter-Quartile Range|Median
1417010|NCT01122394|Secondary|Dietary Sodium|self-reported stage of change for adherence to DASH (low-sodium) diet. Pre-action refers to participants reporting that they were in pre-contemplation (no plans to adhere to DASH diet in the next 6 months), contemplation (planning to adhere within the next 6 months) or preparation (planning to adhere within the next month), while action refers to participants reporting that they are in the action stage of change (became adherent to the DASH diet within the past 6 months) and maintenance refers to participants reporting that they are in the maintenance stage of change (became adherent to the DASH diet at least 6 months ago)|6 months||||participants|||Number
1417011|NCT01122394|Primary|Systolic Blood Pressure||6 months|restricted to only patients enrolled because they met criteria for high blood pressure at enrollment. Participants were not included if they were did not have elevated blood pressure at enrollment|||mm Hg||Inter-Quartile Range|Median
1417012|NCT01122381|Primary|Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline.|"Compare number of migraine headache days pre and post treatment between the ESX and placebo group.~Study terminated early-no outcome data available. The single subject assigned to study drug did not actually take it according to subsequent review of ESX drug levels."|4 weeks, end of treatment and pre-treatment baseline|||||||
1417013|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Overall Relationship domain consists of 2 items (items 13-14), each rated on a scale of 1 (Never) to 5 (Always). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Overall Relationship observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1417014|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Self-Esteem domain consists of 4 items (items 9-12), each rated on a scale of 1 (Never) to 5 (Always). Item 11 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Self-Esteem observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1417015|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Confidence domain measures improvement in confidence; 2 subscales (6 items: Self-Esteem [items 9-12]; Overall Relationship [items 13-14]). Each item range: 1 (Never) to 5 (Always); item 11 reverse scored. Domain score=sum of domain's respective items, then transformed into 0 (least favorable) to 100 (most favorable) scale. Transformed score=100x[(actual raw score-lowest possible raw score)/possible raw score range]. Least Squares Mean change adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Confidence observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1417016|NCT01122264|Secondary|Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR assesses psychosocial outcomes in men with erectile dysfunction. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. Transformed score = 100 x [(actual raw score - lowest possible raw score)/possible raw score range]. Least Squares Mean changes adjusted for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Sexual Relationship observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1417017|NCT01122264|Secondary|Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)|The PAIRS is a 23-item scale that assesses broader psychological/interpersonal outcomes associated with erectile dysfunction and its treatment. Each question is rated on a Likert scale from 1 (strongly disagree) to 4 (strongly agree). The scale consists of 3 domains: Sexual Self-Confidence (items 1-6), Spontaneity domain (items 7-15), and Time Concerns (items 16-23). The average domain score for each domain was calculated by adding the nonmissing items for the respective domain, then dividing by the number of nonmissing items for the respective domain. Each average domain score ranged from 1 to 4. Higher scores represent the following: greater sexual self-confidence (better outcome); greater spontaneity (better outcome); higher time concerns (worse outcome). The Least Squares Mean changes were adjusted for treatment group, country, baseline IIEF-EF severity, baseline domain score, and baseline domain score*treatment (if p<0.10).|Baseline, 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline PAIRS observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1417018|NCT01122264|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks|The participant questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score was obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), then multiplying by 25, thus obtaining a score range from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). Least Squares Mean changes were adjusted for treatment group, country, visit, and visit*treatment.|4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline EDITS observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
1417019|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction on the IIEF over past 4 weeks and consists of 2 questions (items 13 and 14), each rated on a scale from 1 (very dissatisfied) to 5 (very satisfied). Total scores range from 2 to 10; lower numerical scores represent lower overall satisfaction. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Overall Satisfaction observation.|||units on a scale||Standard Error|Least Squares Mean
1417020|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction score over past 4 weeks (1 intercourse attempt item, 2 intercourse satisfaction items). Each item range: 0 (no intercourse attempts/no satisfaction) to 5 (more attempts/high satisfaction). Total scores range: 0-15; lower scores=lower intercourse satisfaction. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Intercourse Satisfaction observation.|||units on a scale||Standard Error|Least Squares Mean
1417021|NCT01122264|Secondary|Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments|The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study and not switching to another treatment) are reported by the median (95% confidence interval). Duration was measured as the number of days from Week 8 to the date of the last dose of the study drug. This outcome measure was estimated using the Kaplan-Meier product-limit method.|8 weeks up to 334 days|The analysis included all randomly assigned participants who completed the 8-week randomized treatment.|||days||95% Confidence Interval|Median
1417022|NCT01122264|Secondary|Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment|The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment.|Baseline through 24 weeks|The analysis included all randomly assigned participants.|||participants|||Number
1417023|NCT01122264|Secondary|Patterns of Erectile Dysfunction Treatment Change|Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported.|Baseline through 24 weeks|All randomly assigned participants were included in the analysis.|||participants|||Number
1417024|NCT01122264|Secondary|Number of Treatment Switches|The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand).|Baseline through 24 weeks|The analysis included all randomly assigned participants who switched erectile dysfunction medication and had a baseline and post-baseline observation.|||number of treatment switches||Standard Deviation|Mean
1417025|NCT01122264|Secondary|Global Assessment Questions (GAQ)|The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity?|24 weeks|The analysis included all randomly assigned participants. The last available GAQ assessment for each participant was used in the analysis.|||participants|||Number
1417026|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)|Participant-assessed diary. Has 5 questions (Question[Q]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit*treatment.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline SEP observation.|||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
1417038|NCT01122030|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantitation, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations (Linear Up/ Log Down).|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1417027|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Sexual Desire observation.|||units on a scale||Standard Error|Least Squares Mean
1417028|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Orgasmic Function observation.|||units on a scale||Standard Error|Least Squares Mean
1417029|NCT01122264|Secondary|Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain|Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline*treatment (if p<0.10), visit, and visit*treatment. Correlation matrix for repeated observations assumed to be unstructured.|Baseline, 4, 8, 16, and 24 weeks|The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF-EF observation.|||units on a scale||Standard Error|Least Squares Mean
1417030|NCT01122264|Primary|Time to Discontinuation of Randomized Treatment|Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.|Baseline up to 334 days|The analysis included all randomly assigned participants.|||days||95% Confidence Interval|Median
1417031|NCT01122238|Primary|Percent Change in Cigarettes Smoked Per Day (CPD)|"Percent Change in Cigarettes Smoked Per Day (CPD) is computed as the percent change in self-reported cigarettes smoked per day at the assessment endpoint relative to baseline CPD; this outcome will be analyzed in a linear regression analysis model.~Note: This Percent change in Cigarettes Smoked Per Day (CPD) primary outcome replaces average number of cigarettes per day in the past week (now designated as a secondary outcome) because the percent change metric allows better comparison with prior research in this area and the results for both outcomes are highly similar."|Assessed at week 26 relative to baseline CPD.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.|||Percent Change in cigarettes per day||Standard Deviation|Mean
1417032|NCT01122238|Secondary|Average Number of Cigarettes Per Day in the Past Week.||Assessed at baseline and week 26.|Adult smokers not yet motivated to quit smoking. The project design measured change in the smoking patterns of these individuals.|||Change in cigarettes per day||Standard Deviation|Mean
1417033|NCT01122160|Primary|Gastric pH||1 hour prior to gastric emptying on Day 7 of the given intervention||||pH||Standard Deviation|Mean
1417034|NCT01122108|Other Pre-specified|Weighted vs. Unweighted Composite BASA Scale Scores|Aggregate scores were calculated for both the unweighted and weighted BASA scale scores for both Colesevlam HCL (3.75G) and Cholestyramine (12g). The best possible total BASA score is 20 and the worst possible total BASA score is 4. For the weighted version of the scale, the best possible total score is 60 and the worst possible total score is 4.|1 Day||||Units on a BASA Scale||Standard Deviation|Mean
1417035|NCT01122108|Primary|Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug.|The bile acid sequestrant acceptability (BASA) scale has 4 scoring categories: taste, texture, appearance, and mixability. Participants rank each category separately. The best possible score for each category is 5, and the worst possible score for each category is 1.|1 Day||||Units on BASA Scale||Standard Deviation|Mean
1417036|NCT01122030|Secondary|Apparent Elimination Half-life of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. The apparent elimination half-life was calculated using the formula t1/2,z = (ln2)/λZ|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||hours||Geometric Coefficient of Variation|Geometric Mean
1417037|NCT01122030|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method. Area under the plasma concentration versus time curve from time zero to infinity, calculated using the formula: AUC0-inf = AUC0-t + Ct/λZ where Ct was the last measurable concentration and λZ was the apparent terminal elimination rate constant.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417107|NCT01121666|Secondary|Embryo Quality: Absence of Multinucleation|"Main embryo quality parameter absence of multinucleation observed."|Day 3|Intention to treat population|||Percentage of absent multinucleation|||Number
1417039|NCT01122030|Secondary|Time to Maximum Observed Plasma Concentration of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|PK population|||hours||Full Range|Median
1417040|NCT01122030|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995|The plasma concentration of naldemedine and its metabolite Nor-S-297995 were measured by liquid chromatography/tandem mass spectrometry (LC/MS/MS) method.|Blood samples were collected predose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose.|The pharmacokinetic (PK) analysis population included all randomized participants who received study drug and had at least one post-dose PK assessment completed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417041|NCT01122030|Secondary|Percentage of Participants With Webster Opiate Withdrawal Scale (WOWS) Score > 8 at Any Time During the Study|The Webster Opiate Withdrawal Scale (WOWS) assessment consisted of 7 questions which rate the severity of opiate withdrawal symptoms, including sweating, sleep, bone or joint aches, runny nose or tearing, gastrointestinal upset, anxiety or irritability and gooseflesh skin. Each symptom was rated on a scale from 0 (not present/no issues) to 4 or 5 (severe). The total score was calculated by summing the 7 individual scores and ranged from 0 (no withdrawal symptoms) to 29 (worst symptoms).|The WOWS assessment was performed at Screening, Day 14, Day 15 at pre-dose , and 24 and 48 hours post-dose and at the Follow-up/End of Study visit (Day 24).|Safety population|||percentage of participants||95% Confidence Interval|Number
1417042|NCT01122030|Secondary|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score > 8 at Any Time During the Study|The COWS assessment consisted of 11 questions which rated the severity of opiate withdrawal symptoms, including resting pulse rate, gastrointestinal upset, sweating, restlessness, pupil size, tremor, anxiety or irritability, bone or joint aches, gooseflesh skin, yawning, and runny nose or tearing. Each symptom was rated on a scale from 0 (not present) to 4 or 5 (most severe). The total score was calculated by summing the 11 individual scores and ranged from 0 (no withdrawal symptoms) to 48 (worst symptoms).|The COWS assessments were performed at Screening, on Day 14, Day 15 (pre-dose and 1, 2, 3, 4, 5, 6 and 8 hours post-dose, and at unscheduled times as signs or symptoms indicate), on Days 16 and 17, and on Day 24/End of Study.|Safety population|||percentage of participants||95% Confidence Interval|Number
1417043|NCT01122030|Secondary|Change From Baseline in Number of Rescue Medications Used Per Day|Baseline was defined as the average number of rescue medications used per day prior to receiving study drug (Day 1 to Day 15). The number of rescue medications used per day at 24 hours and 48 hours post-dose was calculated as the average number of rescue medications used per day from 0 to 24 hours and 0 to 48 hours post-dose, respectively.|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||rescue medications / day||Standard Deviation|Mean
1417044|NCT01122030|Secondary|Change From Baseline in the Number of Bowel Movements With No Straining Per Day|"Straining during BMs was graded using the following scale:~0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score = 0.~Baseline was defined as the average number of BMs without straining per day prior to receiving study drug (Day 1 to Day 15). The number of BMs without straining per day at 24 hours and 48 hours post-dose was calculated as the average number of BMs with no straining per day from 0 to 24 hours and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||bowel movements with no straining / day||Standard Deviation|Mean
1417045|NCT01122030|Secondary|Change From Baseline in Number of False Start Bowel Movements Per Day|"A false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted) based on the question “In the past 24 hours, how many times did you try to have a bowel movement but were unsuccessful? Baseline was defined as the average number of false start BMs per day prior to receiving study drug (Day 1 to Day 15).~The number of false start BMs per day at 24 hours and 48 hours post-dose was calculated as is the average number of false start BMs per day from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||false start bowel movements / day||Standard Deviation|Mean
1417046|NCT01122030|Secondary|Change From Baseline in BM Consistency|"Consistency of BMs was measured using the Bristol Stool Scale, as follows:~1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.~Baseline was defined as the average consistency of BMs prior to receiving study drug (Day 1 to Day 15). BM consistency at 24 hours and 48 hours post-dose was calculated as the average scores from all bowel movements from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
1417047|NCT01122030|Secondary|Change From Baseline in Abdominal Discomfort|"Participants were asked to rate their abdominal discomfort for the past 24 hours using the following scale:~0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. Baseline was defined as the average abdominal discomfort score prior to receiving study drug (Day 1 to Day 15). Abdominal discomfort at 24 hours and 48 hours post-dose was calculated as the mean score from 0 to 24 and 0 to 48 hours post-dose respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
1417048|NCT01122030|Secondary|Change From Baseline in Abdominal Bloating|"Participants were asked to rate their abdominal bloating for the past 24 hours using the following scale:~0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe. Baseline was defined as the average abdominal bloating score prior to receiving study drug (Day 1 to Day 15). Abdominal bloating at 24 hours and 48 hours post-dose was calculated as the mean score from 0 to 24 and 0 to 48 hours post-dose respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
1418028|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).|1 month|FAS population|||percentage of participants|||Number
1417049|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Complete Bowel Movements Per Day|A complete bowel movement (CBM) was defined as a bowel movement that resulted in a sensation of complete evacuation based on the question “Did you have a feeling of complete emptying after the bowel movement?” Baseline was defined as the average number of CBMs per day prior to receiving study drug (Day 1 to 15). Forty-eight hours post-dose was calculated as the average number of CBMs per day from 0 to 48 hours post-dose.|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete bowel movements / day||Standard Deviation|Mean
1417050|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Complete Bowel Movements Per Day|A complete bowel movement (CBM) was defined as a bowel movement that resulted in a sensation of complete evacuation based on the question “Did you have a feeling of complete emptying after the bowel movement?” Baseline was defined as the average number of CBMs per day prior to receiving study drug (Day 1 to Day 15).|Baseline and 24 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete bowel movements / day||Standard Deviation|Mean
1417051|NCT01122030|Secondary|Change From Baseline in Straining During Bowel Movements|"Straining during BMs was graded using the following scale: 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.~Baseline was defined as the average straining score of all BMs prior to receiving study drug (Day 1 to Day 15). The straining score at 24 and 48 hours post-dose was calculated as the average straining score from all bowel movements from 0 to 24 and 0 to 48 hours post-dose, respectively."|Baseline, 24 hours post-dose and 48 hours post-dose|Intent-to-treat population with available data at each time point|||units on a scale||Standard Deviation|Mean
1417052|NCT01122030|Secondary|Time to First Complete Spontaneous Bowel Movement|The time to first CSBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant’s first CSBM was counted as an event and the time to first CSBM after dosing was calculated from the date and time of first dosing until the date and time of first CSBM. Participants who dropped out or were lost to follow-up before the first CSBM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population|||hours||95% Confidence Interval|Median
1417053|NCT01122030|Secondary|Time to First Bowel Movement|The time to first BM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant’s first BM was counted as an event and the time to first BM after dosing was calculated from the date and time of first dosing until the date and time of first BM. Participants who dropped out or were lost to follow-up before the first BM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population|||hours||95% Confidence Interval|Median
1417054|NCT01122030|Secondary|Time to First Spontaneous Bowel Movement|The time to first SBM during the Study Drug Administration Period was summarized using Kaplan-Meier estimates. Each participant’s first SBM was counted as an event and the time to first SBM after dosing was calculated from the date and time of first dosing until the date and time of first SBM. Participants who dropped out or were lost to follow-up before the first SBM were censored.|From first dose on Day 15 through Day 17|Intent-to-treat population|||hours||95% Confidence Interval|Median
1417055|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A complete spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used and the bowel movement resulted in a sensation of complete evacuation (based on the question of “having a feeling of complete emptying after the bowel movement”).~Baseline was defined as the average number of CSBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of CSBMs per day from 0 to 48 hours post-dose."|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete spontaneous bowel movements/day||Standard Deviation|Mean
1417056|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A complete spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used and the bowel movement resulted in a sensation of complete evacuation (based on the question of “having a feeling of complete emptying after the bowel movement”).~Baseline was defined as the average number of CSBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15)."|Baseline and 24 hours post-dose|Intent-to-treat population; LOCF imputation was used|||complete spontaneous bowel movements/day||Standard Deviation|Mean
1417057|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in Number of Bowel Movements Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. Baseline was defined as the average number of BMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of BMs per day from 0 to 48 hours post-dose.|Baseline and 48 hours post-dose|Intent-to-treat population; LOCF imputation was used|||bowel movements / day||Standard Deviation|Mean
1417058|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Bowel Movements (BM) Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. Baseline was defined as the average number of BMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15).|Baseline and 24 hours post-dose|Intent-to-treat; LOCF imputation was used|||bowel movements / day||Standard Deviation|Mean
1417059|NCT01122030|Secondary|Change From Baseline to 48 Hours Post-dose in the Number of SBMs Per Day|Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used in the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15). Forty-eight hours post-dose was defined as the average number of SBMs per day from 0 to 48 hours post-dose.|Baseline (Day 1 to Day 15) and Day 15 to Day 17 (0 to 48 hours post-dose)|Intent-to-treat population; LOCF imputation was used|||Spontaneous bowel movements / day||Standard Deviation|Mean
1417486|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1417060|NCT01122030|Secondary|Change From Baseline to 24 Hours Post-dose in Number of Spontaneous Bowel Movements (SBMs) Per Day|"Participants completed a bowel function assessment daily diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement where no laxative or enema was used in the 24 hours preceding the bowel movement.~Baseline was defined as the average number of SBMs per day during the 2 weeks prior to receiving study drug (Day 1 to Day 15)."|Baseline (Day 1 to Day 15) and Day 15 to 16 (0 to 24 hours post-dose)|All randomized participants who received study drug and had at least 1 post-dose efficacy assessment completed (intent-to-treat population). Last observation carried forward (LOCF) imputation was used.|||spontaneous bowel movements / day||Standard Deviation|Mean
1417061|NCT01122030|Primary|Number of Participants With Adverse Events|"Severity of adverse events (AEs) was graded according to the following definitions:~Mild: The subject experiences awareness of symptoms but these are easily tolerated or managed without specific treatment~Moderate: The subject experiences discomfort enough to cause interference with usual activity, and/or the condition requires specific treatment~Severe: The subject is incapacitated with inability to work or do usual activity, and/or the event requires significant treatment measures.~The relationship of the event to the study drug was determined by the investigator.~A serious adverse event (SAE) is defined as any AE occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect."|From the first dose of study drug on Day 15 up to Day 24.|All participants who received any amount of study drug (safety population).|||participants|||Number
1417062|NCT01121991|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation.|AEs: Any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. TEAEs: AEs that occur during treatment with the study drug. It also included incidences of mild, moderate and severe ovarian hyperstimulation syndrome (OHSS). SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|From stimulation Day 1 (S1) to post-hCG days 35-42 (safety visit).|ITT population: all participants who received at least one dose of the study drug.|||Number of participants|||Number
1417063|NCT01121991|Secondary|Pregnancy Loss Per Clinical Pregnancy|Preclinical miscarriage: Spontaneous cessation of a biochemical pregnancy. Early spontaneous abortion: Any spontaneous abortion occurring after confirmation of clinical pregnancy and before completion of 12 weeks of gestation. Late spontaneous abortion: any spontaneous abortion occurring between completion of 12 weeks of gestation and prior to a viable stage. Pregnancy loss per clinical pregnancy was measured as a percentage.|Post-hCG days 35-42.|Participants with confirmed clinical pregnancies.|||Percentage of pregnancy loss|||Number
1417064|NCT01121991|Secondary|Number of Live Births|A live birth occurs when a fetus, whatever its gestational age, exits the maternal body and subsequently shows any sign of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord, for however brief a time and regardless of whether the umbilical cord or placenta are intact.|Post-hCG days 15-20 to pregnancy follow up.|ITT population: all participants who received at least one dose of the study drug.|||Live births|||Number
1417065|NCT01121991|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Post-hCG Day 35-42.|ITT population: all participants who received at least one dose of the study drug.|||participants|||Number
1417066|NCT01121991|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy: A positive pregnancy test defined as hCG level >10 IU/L in a sample taken at least 14 days after Day 3 embryo transfer or 12 days after Day 5/6 embryo transfer with no further ultrasound confirmation of the existence of a gestational sac in the uterus. Clinical pregnancy: Existence of at least one ultrasonography confirmed gestational sac in the uterus, with or without heartbeat.|Post-hCG days 15-20 and post-hCG days 35-42.|ITT population: all participants who received at least one dose of the study drug.|||participants|||Number
1417067|NCT01121991|Secondary|Mean Number of Oocytes Retrieved Per Number of Follicles Aspirated on the Day of Ovum Pick up|Mean number of oocytes retrieved per number of follicles aspirated on the day of ovum pick up was calculated. Oocyte retrieval is a technique used in in vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|On day of ovum pick up (Day 1 or 2 after hCG administration)|ITT population: all participants who received at least one dose of the study drug and underwent vaginal ovum pick up.|||oocytes per aspirated follicle||Standard Deviation|Mean
1417068|NCT01121991|Primary|Mean Number of Mature Oocytes Per Participant Who Underwent Ovum Pick up for In Vitro Fertilization (IVF)|Mean number of oocytes undergoing ovum pick up for IVF were calculated for each participant. IVF is a process by which egg cells are fertilized by sperm outside the body, in-vitro.|On the day of ovum pick up (Day 1 or 2 after hCG administration).|Analysis population includes those participants undergoing IVF whose oocytes were assessed for maturity. Mature oocytes can be considered as Metaphase II oocytes.|||oocytes||Standard Deviation|Mean
1417069|NCT01121991|Primary|Mean Number of Metaphase II Oocytes Per Participant Who Underwent Ovum Pick up for Intra-cytoplasmic Sperm Injection (ICSI)|Mean number of metaphase II oocytes was calculated for each participant undergoing ovum pick up for ICSI. ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|On the day of ovum pick up (Day 1 or 2 after human chorionic gonadotropin [hCG] administration).|Analysis population includes those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope.|||Metaphase II Oocytes||Standard Deviation|Mean
1417490|NCT01119963|Secondary|Duration of Latency Period|"Secondary Outcomes:~- Duration of latency period (time from randomization to birth)"|average number of days measured from day of study entry until day of delivery|Intent to treat population (included all participants who were randomized, whether they received study medication or not).|||days||Standard Deviation|Mean
1417070|NCT01121939|Secondary|Disease Control Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment or Experience Stable Disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither Sufficient Shrinkage to Qualify For PR, Nor Sufficient Increase to Qualify for Progressive Disease; Disease Control Rate = CR + PR + SD.|18 months|Includes all patients|||percentage of participants|||Number
1417071|NCT01121939|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)|||months||95% Confidence Interval|Median
1417072|NCT01121939|Secondary|Progression-Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all patients (patients in both the typical carcinoid and pancreatic islet cell groups received the same treatment)|||months||95% Confidence Interval|Median
1417073|NCT01121939|Secondary|Define Toxicity and Safety|To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer - defined by grade 3/4, treatment-related toxicity|18 months|All patients on study|||participants|||Number
1417074|NCT01121939|Primary|Objective Response Rate (ORR)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all patients|||percentage of participants|||Number
1417075|NCT01121926|Secondary|Percentage Peak-Trough Fluctuation (%PTF)|"Percentage Peak-Trough Fluctuation (%PTF) of trazodone calculated as [100*(Cmax-Cmin)/Cav].~Cmax: Maximum plasma concentration Cmin: Minimum plasma concentration Cav: Average plasma concentration"|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||Percentage Peak-Trough Fluctuation||Standard Deviation|Mean
1417076|NCT01121926|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter calculated as follows:~((Cmax,ss - Cmin,ss)/Cmin,ss)*100.~Where:~Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state.~It was calculated over 24 hours on day 9."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||Percentage swing||Standard Deviation|Mean
1417077|NCT01121926|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure (Tmax) at steady state.|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||hours||Full Range|Median
1417078|NCT01121926|Secondary|Plasma Concentration at 24 Hours Post-evening Dose (C24h)|Plasma concentration at 24 hours post-evening dose (C24h) in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
1417079|NCT01121926|Secondary|Minimum Plasma Concentration (Cmin,ss)|Minimum plasma concentration at steady state (Cmin,ss). Measured in nanograms per milliliter (ng/mL)|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
1417080|NCT01121926|Primary|Bioequivalence Based on AUCss|"AUCss = Area under the plasma concentration curve (AUC) vs. time data pairs at steady state (ss): AUCss.~Measured in nanograms x hours per milliliter (ng*h/mL)."|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng*h/mL||Standard Deviation|Mean
1417081|NCT01121926|Primary|Bioequivalence Based on Cmax,ss|Cmax,ss = Maximum plasma concentration (Cmax) at steady state (ss): (Cmax,ss). Measured in nanograms per milliliter (ng/mL).|9 days|The dataset for pharmacokinetic analysis comprised the 27 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
1417082|NCT01121913|Secondary|Apparent First Order Terminal Rate Constant [λz]|Apparent First order terminal rate constant [λz] of trazodone in plasma expressed in 1/hours.|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||1/hours||Standard Deviation|Mean
1417083|NCT01121913|Secondary|Time to the Maximum Concentration (Tmax)||72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||Hours||Full Range|Median
1417084|NCT01121913|Secondary|Apparent Terminal Half-life (t½.z)|Apparent terminal half-life (t½.z) of trazodone in hours|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||Hours||Standard Deviation|Mean
1417085|NCT01121913|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
1417086|NCT01121913|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).~Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||ng*h/mL||Standard Deviation|Mean
1417087|NCT01121913|Primary|Bioequivalence Based on AUC(0-t)|"AUC(0-t) = Area under the plasma concentration curve vs (versus) time data pairs, where t is the time of the last quantifiable concentration.~Measured in nanogram x hours per milliliter (ng*h/mL)."|72 hours|The dataset for pharmacokinetic analysis comprised the 19 subjects who completed the study as per protocol.|||ng*h/mL||Standard Deviation|Mean
1417088|NCT01121900|Secondary|Apparent Terminal Half-life (t½.z)|The elimination half-life (T½z) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||Hours||Standard Deviation|Mean
1424564|NCT01059760|Primary|Change From Baseline in Participant Chloride When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
1417089|NCT01121900|Secondary|Apparent Terminal Elimination Rate Constant (λz)|The elimination rate constant of trazodone (Lamda z). It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour. This constant is used in half-life calculations.|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||1/hour||Standard Deviation|Mean
1417090|NCT01121900|Secondary|Time to Maximum Plasma Concentration (Tmax)||68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||Hours||Full Range|Median
1417091|NCT01121900|Secondary|Area Under the Plasma Concentration vs. Time Data Pairs, for the First 24 Hours [AUC(0-24)]||24 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||h*ng/mL||Standard Deviation|Mean
1417092|NCT01121900|Primary|Bioequivalence Based on AUC(0-∞)|"AUC(0-∞) = Area under the plasma concentration curve vs time data pairs, with extrapolation to infinity (∞).~Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||h*ng/mL||Standard Deviation|Mean
1417093|NCT01121900|Primary|Bioequivalence Based on AUC(0-tlast)|"AUC(0-tlast) = Area under the plasma concentration curve (AUC) vs (versus) time data pairs, where tlast is the time of the last quantifiable concentration.~Measured in nanogram x hours per milliliter (ng*h/mL)."|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||hr*ng/mL||Standard Deviation|Mean
1417094|NCT01121900|Primary|Bioequivalence Based Cmax|Cmax = Maximum plasma concentration. Measured in nanogram per milliliter (ng/mL).|68 hours|The dataset for pharmacokinetic analysis comprised the 23 subjects who completed the study as per protocol.|||ng/mL||Standard Deviation|Mean
1417095|NCT01121757|Other Pre-specified|Serum Markers Measured on the First Day of Cycle 1 and on the First Day of Cycle 3||Within 4 months of taking single agent and 6 months of taking the combination|||||||
1417096|NCT01121757|Secondary|Number of Participants With Grade 3 and 4 Toxicities|Evaluate the safety of lenalidomide, azacitidine and the combination of azacitidine + lenalidomide in patients with lymphoma; grading the adverse events using Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0|While taking the study drug and 30 days after the last dose||||participants|||Number
1417097|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 6 months on combination drug.|Only subjects that completed combination drug will be included in analysis.||||||
1417098|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on second drug.|Everyone who started the second drug regimen|||participants|||Number
1417099|NCT01121757|Primary|Overall Response|"Number of patients with a complete or partial response using Cheson criteria for lymphoma.~A complete response is defined as a complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy. A partial response is defined as a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Patients who have been on study drug for at least 2 months will be considered evaluable for response as long as they have had repeat imaging to assess response or clear progression based on physical exam."|Response will be assessed after at least 4 months on first study drug.|Everyone who started the first drug regimen|||participants|||Number
1417100|NCT01121757|Primary|Response Predicted by Molecular Signatures Compared to True Response|"The predicted response (response to therapy vs. no response to therapy) using gene sequencing will be compared to the overall true response (reported in Primary Outcome 2)."|approximately one year|The number of participants who were evaluated for a response were analyzed to see if the prediction of response vs. no response through gene expression matched the true response.|||participants|||Number
1417101|NCT01121666|Secondary|Quality of Oocytes Retrieved|The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population|||Percentage of cells|||Number
1417102|NCT01121666|Secondary|Quality of Oocytes Retrieved|The maturity of the cumulus oophorus was assessed.|After oocyte retrieval, 34 to 36 hours after hCG administration|Intention to treat population|||Percentage of cumulus oophori|||Number
1417103|NCT01121666|Secondary|Ongoing Pregnancy (Second Treatment Cycle)|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|10 weeks after embryo transfer|Population with a second treatment cycle|||Ongoing pregnancies|||Number
1417104|NCT01121666|Secondary|Clinical Pregnancy Rate (Second Treatment Cycle)|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Population with a second treatment cycle|||Clinical pregnancies|||Number
1417105|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of embryos per blastocysts transferred|Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval|Intention to treat population|||embryos per blastocysts transferred||Standard Deviation|Mean
1417106|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with transferred blastocysts|At day 4 and 5|Intention to treat population|||Participants|||Number
1417108|NCT01121666|Primary|Number of Oocytes Retrieved (Intention-to-treat Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.~The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Intention-to-treat population|||Number of retrieved oocytes||Standard Deviation|Mean
1417109|NCT01121666|Secondary|Live Birth Rate|Patients with liveborn children|After childbirth with questionnaire|Intention to treat population|||Patients with liveborn children|||Number
1417110|NCT01121666|Secondary|Ongoing Pregnancy|Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.|Ten weeks after embryo transfer|Intention to treat population|||Ongoing pregnancies|||Number
1417111|NCT01121666|Secondary|Clinical Pregnancy Rate|Presence of at least one intrauterine gestational sac.|Five to six weeks after oocyte retrieval|Intention to treat population|||Clinical pregnancies|||Number
1417112|NCT01121666|Secondary|Implantation Rate|Defined as fetal sac per embryo transferred.|Five to six weeks after oocyte retrieval|Intention to treat population.|||Percentage of implantations|||Number
1417113|NCT01121666|Secondary|Number of Patients With Good Response|"Good response was defined as patients with an oocyte retrieval of four or more oocytes"|Until child birth/miscarriage, up to the end of the study|Intention to treat population.|||Participants|||Number
1417114|NCT01121666|Secondary|Number of Patients With Cycle Cancellation|Number of patients with cycle cancellation was assessed.|Until child birth/miscarriage, up to the end of the study|Intention to treat population|||Number of patients|||Number
1417115|NCT01121666|Secondary|Number of Days of r-hFSH Stimulation|Mean duration of stimulation was assessed.|At the day of hCG administration, up to 16 days|All participants were analyzed.|||days||Standard Deviation|Mean
1417116|NCT01121666|Secondary|Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts||Day 1, 2, 3 and 5 of OPU/fertilisation|Intention to treat population|||Patients with cryopreservation|||Number
1417117|NCT01121666|Secondary|Embryo Quality: Mean Number of Blastomeres|"Main embryo quality parameter mean number of blastomeres"|Day 2 of OPU/fertilisation|Intention to treat population|||Number of blastomeres at day 3||Standard Deviation|Mean
1417118|NCT01121666|Secondary|Fertilisation Rate of Oocytes|Fertilisation rate was assessed|1 day after ovum pick-up|Intention to treat population|||percentage of oocytes||Standard Deviation|Mean
1417119|NCT01121666|Secondary|Quality of Oocytes Retrieved|Number of patients with ovum pick-up|34-36 hours after hCG administration|Intention to treat population|||Participants|||Number
1417120|NCT01121666|Secondary|Total Dose of r-hFSH Administered|Total dose of r-hFSH required was assessed.|Day of hCG administration (after maximum 16 days of r-hFSH treatment)|All participants were analyzed.|||IU||Standard Deviation|Mean
1417121|NCT01121666|Secondary|E2 Concentration at Day 8 and at Day of hCG Administration|The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.|Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)|All participants were analyzed.|||pmol/ L||Standard Deviation|Mean
1417122|NCT01121666|Secondary|Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation|The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.|Day 8 of stimulation|All participants were analyzed.|||Number of follicles||Standard Deviation|Mean
1417123|NCT01121666|Primary|Number of Oocytes Retrieved (Per Protocol Population)|"As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped.~The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes"|34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment|Per protocol population|||Number of retrieved oocytes||Standard Deviation|Mean
1417124|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tmax was observed directly from data as time of first occurrence.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1417125|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Tlast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Tlast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Tlast was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1417126|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmax|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmax) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmax was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417127|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - Cmin|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (Cmin) following dacomitinib alone and in combination with crizotinib are summarized in the below table. Cmin was observed directly from data.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417128|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUC24|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUC24) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUC24 was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417129|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Expansion Cohort 2 With or Without Co-administration of Dacomitinib - AUClast|PK samples for full PK evaluation of dacomitinib were drawn on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) and on C2D1. Dacomitinib and PF-05199265 PK parameter (AUClast) following dacomitinib alone and in combination with crizotinib are summarized in the below table. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (dacomitinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417130|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tmax. Tmax was observed directly from data as time of first occurrence.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1417131|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Tlast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Tlast. Tlast was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1417132|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmax|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmax. Cmax was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417133|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - Cmin|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for Cmin. Cmin was observed directly from data.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1424565|NCT01059760|Primary|Change From Baseline in Participant Sodium When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
1417134|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUC10|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUC10. AUC10 was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417135|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Expansion Cohort 1 With or Without Co-administration of Dacomitinib - AUClast|Participants were evaluated for the effect of dacomitinib on steady-state PK of crizotinib. PK of crizotinib alone was evaluated on Day -1 (one day before C1D1 on which the combination treatment of crizotinib and dacomitinib started) after a lead in period of continuous BID dosing of crizotinib for approximately 12 days (±2 days). PK of crizotinib and dacomitinib in combination treatment was evaluated on Day 1 of Cycle 2. Blood samples for crizotinib full PK were to be collected on Day -1 and Day 1 of Cycle 2. The below table included PK data for AUClast. AUClast was calculated using Linear/Log trapezoidal method.|Day -1 (crizotinib alone), C2D1 (crizotinib + dacomitinib)|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417136|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for dacomitinib and PF-05199265. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1417137|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Tlast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for dacomitinib and PF-05199265. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1417138|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - Cmax|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for dacomitinib and PF-05199265. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417139|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUC24|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUC24 for dacomitinib and PF-05199265. AUC24 was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417140|NCT01121575|Secondary|Plasma Dacomitinib and PF-05199265 Pharmacokinetic Parameter in Escalation Phase - AUClast|At each designated time point, blood samples (3 mL) for PK analysis of dacomitinib and its metabolite, PF 05199265 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for dacomitinib and PF-05199265. AUClast was calculated using Linear/Log trapezoidal method.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417141|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase -Time to Maximum Plasma Concentration (Tmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tmax for crizotinib and PF-06260182. Tmax was observed directly from data as time of first occurrence.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1419273|NCT01105130|Secondary|Adherence|Adherence is the percentage of prescribed pills taken by the participants|8 weeks|Participants who returned pill diaries.|||percentage of prescribed pills||Full Range|Mean
1417142|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Time of Last Quantifiable Concentration (Tlast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Tlast for crizotinib and PF-06260182. Tlast was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||Hour||Full Range|Median
1417143|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Maximum Plasma Concentration (Cmax)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included Cmax for crizotinib and PF-06260182. Cmax was observed directly from data.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417144|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Curve 10 (AUC10)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). AUC10 was calculated using Linear/Log trapezoidal method. The below analysis table included geometric Mean and Geometric Coefficient of Variation of AUC10 for crizotinib and PF-06260182. Arithmetic mean was presented if the n=2.|C1D1, C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417145|NCT01121575|Secondary|Plasma Crizotinib and PF-06260182 Pharmacokinetic Parameter in Escalation Phase - Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Concentration (AUClast)|At each designated time point, blood samples (3 mL) for pharmacokinetic (PK) analysis of crizotinib and its metabolite, PF 06260182 were collected in appropriately labeled collection tubes containing dipotassium ethylenediamine tetra-acetic acid (K2EDTA). The below analysis table included AUClast for crizotinib and PF-06260182. AUClast was calculated using Linear/Log trapezoidal method.|Cycle 1 (C1)/Day 1 (D1), C1D15|The PK parameter analysis population was defined as all participants in the safety analysis population who had at least 1 of the PK parameters of interest. N= Number of participants in the treatment group in the indicated population. n= Number of participants contributing to the summary statistics.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
1417146|NCT01121575|Secondary|Number of Participants With ROS1 Gene Translocation at Baseline|Sample analyses were performed in accordance to GLP guidance and included translocation detection (RNA based) for ROS1 gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. However, number of participants analyzed in the below table included the participants evaluated for ROS1 gene translocation.|||Participants|||Number
1417147|NCT01121575|Secondary|Number of Participants With PIK3CA Mutation at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for PIK3CA gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
1417148|NCT01121575|Secondary|Number of Participants With KRAS Mutation (GLY12CYS) at Baseline|Sample analyses were performed in accordance to GLP guidance and included mutation detection for KRAS gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
1417149|NCT01121575|Secondary|Number of Participants With EGFR Mutation at Baseline|Sample analyses were performed in accordance to Good Laboratory Practice (GLP) guidance and included mutation detection for EGFR gene.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
1417150|NCT01121575|Secondary|Plasma Concentration of sMet by Study Visits|This outcome measure presented the plasma concentration of sMet at different study visits. s-Met was analyzed using an enzyme-linked immunosorbent assay (ELISA).|At screening and Cycle 1 Day 1 (C1D1) (6 hours post dose), and C1D15, C2D1, C2D15 (all predose).|The soluble protein analysis population included participants in safety analysis who had a screening or C1D1 soluble protein assessment, and at least one on-treatment soluble protein assessment (C1D14 C2D1 or C2D14).|||pg/mL||Standard Deviation|Mean
1417151|NCT01121575|Secondary|Number of Participants With c-Met, HER2, EGFR Amplification and ALK Rearrangement at Baseline Using FISH Method|Participants showed amplification of c-Met, HER2, and EGFR in the tumor cells and gene rearrangement of ALK are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Participants|||Number
1417152|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (EGFR, and c-Met) at Baseline Using Fluorescent in Situ Hybridization (FISH) Method|Expression of tumor biomarkers EGFR and cMet at Baseline (using FISH method) are presented in this outcome measure.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||Ratio||Full Range|Median
1417336|NCT01120600|Secondary|Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24|Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-BSAP data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1417153|NCT01121575|Secondary|Expression Analysis of Tumor Biomarkers (HGF, EGFR, and c-Met ) at Baseline Using Immunohistochemistry (IHC) Method|Tumor biomarkers such as HGF, EGFR, and c-Met were analyzed in tumor cells (neoplastic compartment) of tumor specimens from both expansion cohorts 1 and 2 by IHC. The H score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+, where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum calculated score of 0 to maximum calculated score of 300, where 0 correspond to no expression and maximum score of 300 indicates the strongest expression. However, the biomarker expression level (higher or lower) was not a predictor of outcome.|Baseline|The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers.|||H-Score||Full Range|Median
1417154|NCT01121575|Secondary|Progression Free Survival (PFS) in Expansion Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. In Expansion Cohort 1, two participants had censored reasons of “no adequate baseline”, of which one participant had a censored reason “no tumor assessment data available.|||Months||95% Confidence Interval|Median
1417155|NCT01121575|Secondary|Progression Free Survival (PFS) in Escalation Phase|PFS was defined as the time from the date of the first dose to the date of the first documentation of objective tumor progression according to RECIST 1.1 or death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used.|From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||Months||95% Confidence Interval|Median
1417156|NCT01121575|Secondary|Duration of Response for the Only Participant Shown Partial Response in Expansion Phase|This outcome measure presented the duration of response for one participant in expansion cohort 1 who showed partial response.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|This Outcome Measure was only assessed for participants with response.|||Weeks|||Number
1417157|NCT01121575|Secondary|Number of Participants With ORR in Expansion Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants||95% Confidence Interval|Number
1417158|NCT01121575|Secondary|Number of Participants With Objective Response Rate (ORR) in Escalation Phase|ORR was defined as the percent of participants with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) determined by study physicians, relative to the response evaluable population. Participants were considered non-responders until proven otherwise. Thus, participants who: 1) Did not have CR or PR while on study, or 2) Did not have a post-baseline tumor evaluation, or 3) Received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or 4) Died, in progress, or drop out for any reason prior to reaching a CR or PR, were counted as non-responders in the assessment of ORR. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors were confirmed by repeated tumor assessment that were performed 4 weeks after the criteria for response were first met.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants||95% Confidence Interval|Number
1417159|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to RECIST (1.1) as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants|||Number
1417160|NCT01121575|Secondary|Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase|If a participant had not achieved an objective response with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) - 1.1 as determined by the investigators, relative to the response evaluable population, but remained stable for at least 6 weeks after first dose, then the best overall response for such a participant was considered as stable disease.|From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment)|The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment.|||Participants|||Number
1418029|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1417161|NCT01121575|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase|DLTs were those AEs which occurred in Cycle 1 of treatment in Dose Escalation Phase which may be attributed to study drug [combined Crizotinib (PF-02341066) plus Dacomitinib (PF-00299804)] without a clear alternative explanation and despite the use of adequate/maximal medical intervention as dictated by local institutional clinical practices or the judgment of the investigator. The following events were considered DLTs (using CTCAE version 4.02);1. Grade ≥4 hematologic events. 2. Grade ≥3 non-hematological events (except Grade 3/4 asymptomatic hypophosphatemia and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting or diarrhea had to have persisted at Grade 3 or 4 despite maximal medical therapy. Grade 3 hypertension will be considered a DLT only if the event is unmanageable by standard approved pharmacologic agents or if the symptomatic sequelae are identified despite appropriate medical intervention.|Cycle 1 (4 weeks)|The DLT evaluable population was defined as safety analysis (SA) participants in the Dose Escalation phase who did not have a major treatment deviation during the first cycle.|||Participants|||Number
1417162|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||Participants|||Number
1417163|NCT01121575|Primary|Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||participants|||Number
1417164|NCT01121575|Primary|Overview of Treatment-emergent All Causalities AEs in Expansion Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. SAE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using NCI CTCAE v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||Participants|||Number
1417165|NCT01121575|Primary|Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase|AE was any untoward medical occurrence with study drug/ device in a trial participant. Serious adverse event (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were reported from signing of informed consent until 28 days after the last dose of study medication. SAEs were reported after this time frame if considered to be treatment related. The severity of AEs were graded by the investigator using National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v.4.02 and was assessed as Grade 0: no change from normal or reference range; Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling; Grade 5: death related to AE. However the below table included Grade 3, 4, and 5 AEs.|Up to Maximum of treatment duration + 28 days for each participant (could be 295 days)|The safety analysis population included all enrolled participants who had received at least 1 dose of study medication.|||participants|||Number
1417166|NCT01121562|Secondary|Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).|"Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, observed concentration multiplied by 37.5 over actual dose.~SU012662 is an active metabolite of sunitinib."|Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1|"The pharmacokinetics analysis set was defined as all participants who had at least one plasma concentration data at trough sampling with steady-state condition. n in the measured values means number of participants analyzed."|||nanogram/mL||Standard Deviation|Mean
1417167|NCT01121562|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.|Up to 3 years from the last subject registration to the study|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.~OS was not analyzed due to short of events."|||Months||95% Confidence Interval|Median
1418030|NCT01115933|Secondary|Composite Endpoint of All Death/All MI/All Revascularization (DMR)|DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
1417168|NCT01121562|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.~Median PFS had not yet been reached due to short of events."|||Months||95% Confidence Interval|Median
1417169|NCT01121562|Secondary|Tumor Shrinkage|Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.|Up to 799 days of treatment|"Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication. n  in the measured values means number of participants analyzed in the cycle."|||percent change||Standard Deviation|Mean
1417170|NCT01121562|Secondary|Objective Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1417171|NCT01121562|Primary|Clinical Benefit Response Rate (CBR)|"CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks.~Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started."|Up to 799 days of treatment|Full Analysis Set was defined as the population of all enrolled participants in whom well-differentiated pancreatic neuroendocrine tumor had been diagnosed and who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1417172|NCT01121549|Secondary|Time to Disease Progression (TTP)|Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.|Baseline up to Year 3|Time to disease progression was considered complementary to RFS and hence, was not analyzed.||||||
1417173|NCT01121549|Secondary|Recurrence-free Survival (RFS)|Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.|Baseline up to Year 3|A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.|||weeks||Full Range|Median
1417174|NCT01121549|Secondary|Percentage of Participants Who Discontinued the Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||percentage of participants|||Number
1417175|NCT01121549|Secondary|Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy||Baseline up to Year 3|FAS included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
1417176|NCT01121549|Secondary|Number of Participants With Reasons for Discontinuing Exemestane Therapy||Baseline up to Year 3|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
1417177|NCT01121549|Secondary|Number of Missed Exemestane Doses||Week 25, 49, 73, 97, 121, 145|Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported.|||missed doses||Standard Deviation|Mean
1417178|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug|An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
1417179|NCT01121549|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).|Baseline up to 28 days after last dose|Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.|||participants|||Number
1418031|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1417180|NCT01121536|Primary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|"HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of participants with both a baseline and post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1417181|NCT01121536|Primary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. Baseline was the assessment before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both a baseline and post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1417182|NCT01121536|Secondary|Change From Baseline to Endpoint in the Global Assessment for Functioning (GAF) Scale|"The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or the last post-baseline assessment)|Full analysis set of participants with both a baseline and post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1417183|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Clinical Global Impression of Severity (CGI-S) for Depression|"The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set|||units on a scale||Standard Deviation|Mean
1417184|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|"The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set|||units on a scale||Standard Deviation|Mean
1417185|NCT01121536|Primary|Participants With Findings During the Open-Label Study on the Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV)|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The number of participants who had findings on any of the C-SSRS-SLV (SLV=since last visit) categories at any of the time frames are indicated.~- C-SSRS=Columbia Suicide Severity Rating Scale"|Day 1, Week 1, Months 1, 2, 4 and 6 or last post-baseline visit|Safety population; only 19 participants were asked the last three questions as the inclusion of these questions depends on physician assessment.|||participants|||Number
1417186|NCT01121536|Primary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|"The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Month 6 or last post-baseline observation|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline (double-blind study) and treatment assessments during the open-label study.|||units on a scale||Standard Deviation|Mean
1417187|NCT01121536|Primary|Change From Baseline to Endpoint in Body Weight|Baseline was the score before the first dose of study drug in the double-blind study.|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with both baseline and post-baseline assessments.|||kg||Standard Deviation|Mean
1417188|NCT01121536|Secondary|Change From Baseline to Week 1 and Months 1, 2, 4, 6 and Endpoint in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.~Baseline was the score before the first dose of study drug in the double-blind study."|Day 0 (baseline), Week 1, Months 1, 2, 4, 6 and the last post-baseline assessment)|Full analysis set|||units on a scale||Standard Deviation|Mean
1417189|NCT01121536|Primary|Physical Examination Shifts From Baseline to Endpoint|"Baseline is the day prior to double-blind treatment. Assessments are summarized as normal or abnormal. The first assessment is the baseline assessment followed by the endpoint assessment. For example 'normal/abnormal' indicates participants who were normal at baseline and abnormal at endpoint.~HEENT = Head, Eye, Ear, Nose and Throat exam"|Day 0 (baseline), Month 6 (or last post-baseline observation)|Safety population of treated participants with baseline and endpoint assessments Participants n=: General appearance 785, HEENT 784, Chest and lungs 785, Heart 785, Abdomen 785, Musculoskeletal 785, Skin 785, Lymph nodes 780, Neurological 784|||participants|||Number
1417190|NCT01121536|Primary|Change From Baseline to Endpoint in Electrocardiogram (ECG) Values|"ECG was conducted at baseline which was before the first dose of study drug in the double-blind study, and at the month-6 visit of the open-label study (or early termination).~RR= inter-beat intervals"|Day 0 (baseline), Month 6 or last post-baseline observation|Safety population of treated participants with both baseline and post-baseline ECG assessments|||msec||Standard Deviation|Mean
1417191|NCT01121536|Primary|Participants With Clinically Significant Abnormal Vital Signs Values|"Summary of vital signs tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal vital signs are based on FDA Neuropharmacological Division criteria:~Pulse high: >=120 beats per minute (bpm) and increase of >=15 bpm from baseline~Pulse low: <=50 bpm and decrease of >=15 bpm from baseline~Sitting systolic blood pressure high: >=180 mm Hg and increase of >=20 mm Hg from baseline~Sitting systolic blood pressure low: <=90 mm Hg and decrease of >=20 mm Hg from baseline~Sitting diastolic blood pressure high: >=105 mm Hg and increase of >=15 mm Hg from baseline~Sitting diastolic blood pressure low: <=50 mm Hg and decrease of >=15 mm Hg from baseline"|Day 1 to Month 6|Safety population with post-baseline vital signs assessments|||participants|||Number
1417192|NCT01121536|Primary|Participants With Clinically Significant Abnormal Urinalysis Values|Summary of urinalysis tests in which at least one participant had a during study value that was clinically significant abnormal. Criterion for clinically significant abnormal urinalysis tests was >=2 unit increase from baseline.|Day 1 to Month 6|Safety population with post-baseline urinalysis assessments|||participants|||Number
1417193|NCT01121536|Primary|Participants With Clinically Significant Abnormal Hematology Values|"Summary of hematology tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~WBC - white blood cell counts with a normal range of 3.8-10.7 10^9/L.~Hemoglobin with a normal range of 115-181 g/L~Hematocrit with a normal range of 0.34-0.54 L/L~Platelet counts with a normal range of 130-400 10^9/L~ANC= absolute neutrophil counts with a normal range of 1.96-7.23 10^9/L"|Day 1 to Month 6|Safety population with post-baseline hematology assessments|||participants|||Number
1417194|NCT01121536|Primary|Participants With Clinically Significant Abnormal Serum Chemistry Values|"Summary of serum chemistry tests in which at least one participant had a during study value that was clinically significant abnormal. The test name and criterion for clinically significant abnormal appear in each row.~ULN=upper limit of normal~BUN=Blood Urea Nitrogen; Uric acid has a normal range of 125-494 μmol/L. Criterion for clinically significant abnormal are different for men and women.~GGT = gamma-glutamyl transpeptidase with a normal range of 4-61 U/L~ALT = alanine aminotransferase with a normal range of 6-43 U/L~BUN = blood urea nitrogen with a normal range of 1.4-8.6 mmol/L~AST = aspartate aminotransferase with a normal range of 9-36 U/L"|Day 1 to Month 6|Safety population with post-baseline serum chemistry assessments|||participants|||Number
1417195|NCT01121536|Primary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 up to Month 6|Safety population|||participants|||Number
1417196|NCT01121484|Secondary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Week 8|10 centimeter (cm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 = no pain to 10 = worst possible pain. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF|||cm||Standard Deviation|Mean
1417197|NCT01121484|Secondary|Change From Baseline in Quick Inventory of Depressive Symptoms, 16 Question Self-report (QIDS-SR)|This is a 16-item self reported questionnaire that measures depressive symptoms. Improvement reported as change in depressive score. Score ranges from 0 to 42, with higher numbers indicating more severe symptom reporting. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF|||Units on a scale||Standard Deviation|Mean
1417198|NCT01121484|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 8|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: score at observation minus score at baseline.|Baseline, Week 8|FAS|||Units on a scale||Standard Deviation|Mean
1417199|NCT01121484|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Week 8|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 8|FAS; LOCF|||Units on a scale||Standard Deviation|Mean
1417200|NCT01121484|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point scale in which the clinician rated how much the participant's condition has changed compared to baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS; LOCF|||participants|||Number
1417694|NCT01118988|Secondary|Child Symptom Inventory (CSI)|"Assement of somatic symptom complaints~24 items, range 0-96, higher score = more somatic symptoms"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417201|NCT01121484|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D17) at Week 8|HAM-D17, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline: score at observation minus score at baseline.|Baseline, Week 8|Full Analysis Set (FAS) Population: randomized participants who had a baseline HAM-D17 score, took at least 1 dose of investigational product, and had at least 1 postbaseline HAM-D17 evaluation. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1417202|NCT01121406|Secondary|Biomarkers and Pharmacogenetics Analysis (Optional)|This endpoint has not been statistically analysed in the study report|6 months|||||||
1417203|NCT01121406|Secondary|Vss;Apparent Volume of Distribution at Steady State Following Intravenous Administration for BI 6727 BS|Vss;apparent volume of distribution at steady state following intravenous administration for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Litres||Geometric Coefficient of Variation|Geometric Mean
1417204|NCT01121406|Secondary|CL; Total Clearance of BI 6727 BS in Plasma After Intravenous Administration|CL; total clearance of BI 6727 BS in plasma after intravenous administration|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1417205|NCT01121406|Secondary|MRT; Mean Residence Time of BI 6727 BS in the Body|MRT; Mean residence time of BI 6727 BS in the body|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Geometric Coefficient of Variation|Geometric Mean
1417206|NCT01121406|Secondary|t1/2; Terminal Half-life of CD 10899 BS in Plasma|t1/2; Terminal half-life of CD 10899 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Geometric Coefficient of Variation|Geometric Mean
1417207|NCT01121406|Secondary|t1/2; Terminal Half-life of BI 6727 BS in Plasma|t1/2; Terminal half-life of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Geometric Coefficient of Variation|Geometric Mean
1417208|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of CD 10899 BS in Plasma|tmax; time from dosing to maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1417209|NCT01121406|Secondary|Tmax; Time From Dosing to Maximum Measured Concentration of BI 6727 BS in Plasma|tmax; time from dosing to maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
1417210|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of CD 10899 BS in Plasma|Cmax; maximum measured concentration of CD 10899 BS (metabolite of Volasertib BI 6727) in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417211|NCT01121406|Secondary|Cmax; Maximum Measured Concentration of BI 6727 BS in Plasma|Cmax; maximum measured concentration of BI 6727 BS in plasma|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417212|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for CD 10899 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1417213|NCT01121406|Secondary|AUC (0-inf); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity for BI 6727 BS|AUC (0-inf); area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1417487|NCT01120093|Secondary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1417214|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for CD 10899 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for CD 10899 BS (metabolite of Volasertib BI 6727)|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1417215|NCT01121406|Secondary|AUC (0-24); Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to 24 Hours for BI 6727 BS|AUC (0-24); area under the concentration-time curve in plasma over the time interval from 0 to 24 hours for BI 6727 BS|-0.083 hours (h), 2h, 4h, 6h, 24h, 168h and 336 h after first drug administration|All evaluable patients were to be included in the pharmacokinetic analysis. A patient was considered not evaluable if they had an important protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1417216|NCT01121406|Secondary|Clinically Relevant Changes in Laboratory and ECG Data|Clinically relevant changes in laboratory and ECG data|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS|||percentage of participants|||Number
1417217|NCT01121406|Secondary|Incidence and Intensity of Adverse Events According to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Incidence and intensity of adverse events according to the United States National Cancer Institute (US NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|From first treatment administration to 21 days after the last drug administration (Up to 1403 days)|TS|||participants|||Number
1417218|NCT01121406|Secondary|Time to Deterioration in the Three Most Troublesome Disease Specific Symptoms/ Quality of Life (QOL)|"Three most troublesome disease specific symptoms, defined by the patient at baseline.~Patients that have defined more than 3 most troublesome symptoms have not been taken into account in the analysis.~Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks)|TS|||weeks||Inter-Quartile Range|Median
1417219|NCT01121406|Secondary|Time to Deterioration in Abdominal Bloating/ Quality of Life (QOL)|"Time to deterioration in abdominal bloating/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
1417220|NCT01121406|Secondary|Time to Deterioration in Pain/ Quality of Life (QOL)|"Time to deterioration in pain/ Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
1417221|NCT01121406|Secondary|Time to Deterioration in Fatigue/Quality of Life (QOL)|"Time to deterioration in fatigue/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
1417222|NCT01121406|Secondary|Time to Deterioration in Global Health Status/Quality of Life (QOL)|"Time to deterioration in global health status/Quality of life (QOL) and symptom control assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, QLQ-OV28, and individual symptom questionnaires.~The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death."|Every 6 weeks (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
1417223|NCT01121406|Secondary|Biological Progression-free Survival Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Biological PFS including assessment of CA-125 levels was defined as the time from randomisation until the first occurrence of progressive disease according to CA-125, progressive disease according to radiological evidence, or death.~Also according to the below criterias,~In patients with radiological measurable disease, disease progression during study treatment could not be declared on the basis of CA-125 alone.~Patients with elevated CA-125 pre-treatment and normalization of CA-125 had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart or~Patients with elevated CA-125 pre-treatment, which never normalized, had to show evidence of CA-125 ≥ to two times the nadir value on two occasions at least one week apart or~Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 ≥ to two times the upper normal limit on two occasions at least one week apart."|At screening and every 6 weeks thereafter (Up to 213 weeks )|TS|||weeks||Inter-Quartile Range|Median
1417366|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417224|NCT01121406|Secondary|Biological Tumour Response Based on Serum Cancer Antigen 125 (CA-125) According to the Gynaecologic Cancer Intergroup (GCIG) Criteria|"Patients were to have a pre-treatment CA-125 of at least twice the upper limit of normal to be considered for CA-125 response. Patients were not evaluable by CA-125 if they had received mouse antibodies or if they had undergone medical and/or surgical interference with their peritoneum or pleura during the previous 28 days. In eligible patients, a CA-125 response was defined as the moment the CA- 25 was reduced by 50%, with this being confirmed with a consecutive CA-125 assessment not earlier than 28 days after the previous one.~Biological response rate based on serum CA-125 levels was assessed according to the guidelines by the Gynaecologic Cancer Intergroup. Monitoring of blood levels of the tumour marker CA-125 was performed at screening and every 6 weeks thereafter."|At screening and every 6 weeks thereafter (Up to 213 weeks)|TS|||participants|||Number
1417225|NCT01121406|Secondary|Best Overall Response|"Best overall response (BOR) is defined as the best response recorded at any time from the date of randomisation until the end of treatment.~Missing categories signify that no tumour imaging has been performed post baseline, and therefore the response status could not be assessed."|time from the date of randomisation until study completion/discontinuation; Up to 213 weeks|TS|||participants|||Number
1417226|NCT01121406|Secondary|Overall Survival (OS)|OS is defined as time from randomisation to death irrespective of the cause of the death.|From randomization until death or study discontinuation; Up to 213 weeks|TS|||weeks||Inter-Quartile Range|Median
1417227|NCT01121406|Secondary|Progression Free Survival (PFS)|"Progression-free survival of a patient was based on the investigator’s assessment; it was defined as the number of days from the date of randomisation until the date of either disease progression or death from any cause, whichever occurred first.~Definition of disease progression according to RECIST version 1.1; Patients with measurable tumour lesions at baseline, Target-lesions: at least a 20% increase in the sum of diameters of target lesions, the sum of diameters must also demonstrate an absolute increase of at least 5 mm,taking as reference the smallest sum on study, or appearance of 1 or more new lesions.~Non-target lesions: unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions Patients with non-measurable tumour lesions at baseline, Non-target lesions: requires unequivocal progression of existing non-target lesions or appearance of 1 or more new lesions"|From randomization until disease progression, death or study discontinuation; Up to 213 weeks|TS|||weeks||Inter-Quartile Range|Median
1417228|NCT01121406|Primary|Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).|Week 24|TS|||percentage of participants||95% Confidence Interval|Number
1417229|NCT01121393|Secondary|Changes in Safety Laboratory Parameters|"Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase.~For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented.~Only data collected up to the analysis cut-off date (27 December 2013) were considered."|From first administration of study medication up to 28 days after the last administration of study medication up to 42.2 months|Treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated according to the treatment actually received. Patients with a baseline and at least one on-treatment assessment of the parameter of interest (Number of patients (N) are specified in the category title).|||percentage of participants|||Number
1417230|NCT01121393|Secondary|Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events|"Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.~Only data collected up to the analysis cut-off date (27 December 2013) were considered."|From first administration of study medication up to 28 days after the last administration of study medication up to 42.2 months|The treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.|||percentage of participants|||Number
1417231|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 43|Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 43 (course 3, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417232|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 29|Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 29 (course 2, visit 2)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1417233|NCT01121393|Secondary|Pharmacokinetics of Afatinib at Day 22|Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).|Day 22 (course 2, visit 1)|All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.|||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1417242|NCT01121393|Secondary|Time to Objective Response (OR)|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.~Outcome data are the percentage of patients with OR by each scheduled tumour assessment.~Only data collected up until the analysis cut-off date (27 December 2013) were considered."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The RS included all patients randomised to receive treatment, whether treated or not.|||percentage of participants|||Number
1417234|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Pain|"HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.|||months||95% Confidence Interval|Median
1417235|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea|"HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.|||months||95% Confidence Interval|Median
1417236|NCT01121393|Secondary|Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing|"HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.~Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~The median is Kaplan-Meier estimates."|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set.|||months||95% Confidence Interval|Median
1417237|NCT01121393|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|"The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status.~Only data collected up to the analysis cut-off date (27 December 2013) were considered.~ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;~Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work;~Ambulatory (>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities;~Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours;~Completely disabled, cannot carry on any selfcare, totally confined to bed or chair;~Dead"|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set. Data only presented for patients with a baseline and at least one post-baseline assessment of ECOG status.|||percentage of participants|||Number
1417238|NCT01121393|Secondary|Change From Baseline in Body Weight|The change from baseline to the lowest and the last body weight recorded or during the the study. Only data collected up until the analysis cut-off date (27 December 2013) were considered.|Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 42 months.|The randomised set. Data only presented for a patient with a baseline and at least on post-baseline assessment of weight.|||kilogram (kg)||Standard Deviation|Mean
1417239|NCT01121393|Secondary|Tumour Shrinkage|"Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline.~The means are adjusted for baseline sum of lesions and EGFR mutation category."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set. There were ony 220 patients in the Afatinib arm and 101 patients in the Gemcitabine / Cisplatin arm with baseline and post-baseline target lesion measurements.|||millimetre (mm)||Standard Error|Mean
1417240|NCT01121393|Secondary|Duration of Disease Control|"For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set with disease control.|||months||95% Confidence Interval|Median
1417241|NCT01121393|Secondary|Duration of Objective Response|"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.~For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered.~A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The Randomised set with an objective response.|||months||95% Confidence Interval|Median
1417243|NCT01121393|Secondary|Overall Survival (OS)|"OS is defined as the time from randomisation to death. For patients who had not died by the cut-off date (27 Dec 2013), the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.~Median time results from unstratified Kaplan-Meier estimates."|From randomisation up to 27 Dec. 2013 cut off date for this analysis|The randomised set.|||months||95% Confidence Interval|Median
1417244|NCT01121393|Secondary|Disease Control (DC)|"DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.~Only data collected up until the analysis cut-off date (27 December 2013) were considered."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set.|||percentage of participants||95% Confidence Interval|Number
1417245|NCT01121393|Secondary|Objective Response (OR)|"OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.~CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.~PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.~Only data collected up until the analysis cut-off date (27 December 2013) were considered.~(Exact 95% Confidence interval by Clopper and Pearson.)"|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set.|||percentage of participants||95% Confidence Interval|Number
1417246|NCT01121393|Primary|Progression-free Survival|"The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.~Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates."|Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168|The randomised set (RS) included all patients randomised to receive treatment, whether treated or not.|||months||95% Confidence Interval|Median
1417247|NCT01121263|Secondary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:~Death~Stroke~Myocardial infarction~Repeat revascularization"|Occurence of MACCE through the end of study up to two years||||participants|||Number
1417248|NCT01121263|Primary|Major Adverse Cardiac and Cerebrovascular Event (MACCE)|"For the purposes of this study MACCE is defined as a non-weighted composite score comprised of the following components:~Death~Stroke~Myocardial Infarction~Repeat Revascularization"|Month 12||||participants|||Number
1417249|NCT01121250|Primary|Spouse Self-report of Resilience|Resilience as measured on the Connor-Davidson Resilience Scale, measured from 0-100; higher scores show greater resilience|Baseline, 6 months, and 12 months|All participants with resilience data at baseline, 6 and 12 months|||units on a scale||Standard Deviation|Mean
1417250|NCT01121250|Primary|Spouse Self-report of Depression|Depression symptoms as measured on the Patient Health Questionnaire (PHQ-9), measured from 0-27, with higher numbers indicating more depression|Baseline, 6 months, and 12 months|All participations with depression data at baseline, six and 12 months|||units on a scale||Standard Deviation|Mean
1417251|NCT01121250|Primary|Spouse Self-report of Anxiety|Anxiety symptoms from the Generalized Anxiety Disorder-7 (GAD-7) scale, measured from 0-21, higher scores indicate greater anxiety|Baseline, 6 months, and 12 months|All participants with anxiety data at baseline, six months, and twelve months|||units on a scale||Standard Deviation|Mean
1417252|NCT01121224|Secondary|Number of Participants With Definite or Probable Stent Thrombosis|"Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.~Probable Stent Thrombosis will clinically be considered to have occurred after index Saphenous Vein aortocoronary bypass Graft (SVG) stenting (the Percutaneous Coronary Intervention (PCI) immediately after randomization) in the following cases: a) any unexplained death within the first 30 days OR b) Irrespective of the time after the index procedure, any MI which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|12 months||||Participants|||Count of Participants
1417253|NCT01121224|Secondary|Number of Participants With Any Revascularization||12 months||||Participants|||Count of Participants
1417254|NCT01121224|Secondary|Number of Participants With Target Vessel Myocardial Infarction||12 months||||Participants|||Count of Participants
1417255|NCT01121224|Secondary|Number of Participants With Target Lesion Revascularization (TLR)||12 months||||Participants|||Count of Participants
1417256|NCT01121224|Secondary|In-stent Neointima Proliferation as Measured by Intravascular Ultrasonography.||12 months||2018-09-30|09/2018||||
1417257|NCT01121224|Secondary|Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided.||12 months||2018-09-30|09/2018||||
1417258|NCT01121224|Secondary|Stroke.||12 months||2018-09-30|09/2018||||
1417259|NCT01121224|Secondary|In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.||12 months||2018-09-30|09/2018||||
1417260|NCT01121224|Secondary|Patient-oriented and Device-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.||12 months||2018-09-30|09/2018||||
1417261|NCT01121224|Secondary|Number of Participants With Target Vessel Revascularization (TVR)||12 months||||Participants|||Count of Participants
1417711|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng/mL||Standard Deviation|Mean
1417262|NCT01121224|Secondary|Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition|"Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.~Angiographic Confirmation of Stent Thrombosis will be defined as the presence of thrombus originating in a study stent, or in the segment 5mm proximal or distal to the stent AND fulfillment of at least one of the following 5 criteria within a 48 hour time window:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes suggestive of acute ischemia~Rise and fall of cardiac biomarkers~Nonocclusive intracoronary thrombus seen in multiple projections, or persistence of contrast material within the lumen, or a visible embolization of intraluminal material downstream~Occlusive intracoronary thrombus Pathological Confirmation of stent thrombosis will be defined as evidence of recent thrombus with the stent determined at autopsy or via examination of tissue retrieved following thrombectomy."|12 months||||Participants|||Count of Participants
1417263|NCT01121224|Secondary|Number of Participants With Myocardial Infarction (MI) After Discharge From the Initial Stenting Procedure.||12 months||||Participants|||Count of Participants
1417264|NCT01121224|Secondary|Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.||12 months||||Participants|||Count of Participants
1417265|NCT01121224|Secondary|Procedural Success and Complications (Post-procedural Myocardial Infarction and Post-procedural Bleeding).||Index hospitalization||2018-09-30|09/2018||||
1417266|NCT01121224|Secondary|Incremental Cost-effectiveness of DES Relative to BMS.||12 months||2018-09-30|09/2018||||
1417267|NCT01121224|Primary|Number of Participants With Target Vessel Failure (TVF), Which Will be Defined as the Composite of Cardiac Death, Target Vessel Myocardial Infarction and Target Vessel Revascularization.||12 months||||Participants|||Count of Participants
1417268|NCT01121211|Primary|Change From Baseline in Depression Symptom Severity|Hamilton Depression Rating Scale (HAM-D) (Higher score = greater depression symptom severity; Score Range 0 - ≥ 23)|Baseline, 24 weeks|All subjects who received at least one dose of study medication|||HAM-D score on a scale||Standard Deviation|Mean
1417269|NCT01121211|Primary|Change From Baseline in Weight|Weight in kilograms|Baseline, 24 Weeks|All subjects who received at least one dose of study medication|||kilograms||Standard Deviation|Mean
1417270|NCT01121185|Post-Hoc|Time To Viral Rebound Post-Transplantation(Serum HCV RNA Increased ≥ 1 log10 From Viral Nadir)|The time of viral rebound was defined as the time of the first measurement of serum HCV RNA increased ≥ 1 log10 from the viral nadir (the lowest serum HCV RNA level post-transplantation). Serum HCV RNA was measured by RT-PCR.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||days||Full Range|Mean
1417271|NCT01121185|Secondary|Time to Onset of Recurrence of Detectable HCV RNA Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||days|||Number
1417272|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Total Bilirubin|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the total bilirubin at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||mg/dL||Full Range|Mean
1417273|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / Alanine Aminotransferase (ALT)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the ALT at each time-point.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||U/L||Full Range|Mean
1417274|NCT01121185|Secondary|Graft Function Assessed by Measurement of Biochemical and Synthetic Function at Multiple Time Points / International Normalized Ratio (INR)|Biochemical function was assessed by measurement of alanine aminotransferase (ALT) and total bilirubin and synthetic function was assessment by measurement of the pro-thrombin time (reported as the international normalized ratio, INR) at multiple time-points during the 56-day study period. The table below displays the INR at each time-point. The INR is the ratio of a patient's prothrombin time to a control sample, raised to the power of the ISI value (International Sensitivity Index) for the batch of tissue factor being used for the assay.|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||unitless||Full Range|Mean
1417275|NCT01121185|Secondary|Histologic Evidence of Hepatitis by Histologic Activity Index (HAI) Score at Baseline and Day 42|Liver biopsies obtained at baseline (day 0) and day 42 post-transplantation were assessed for histologic evidence of hepatitis by a pathologist blinded to treatment assignment using the Ishak modification of the Knodell histologic grading system to assign a histologic activity index (HAI) score. The HAI score consists of a sum of four components: 1) periportal or periseptal interface hepatitis; 2) confluent necrosis; 3) focal lytic necrosis, apoptosis and focal inflammation; 4) portal inflammation. The total HAI score can range from a minimum of 0 to a maximum of 18, with higher scores indicating more severe hepatic inflammation.|Baseline Day 0 and Day 42|The 11 subjects who were randomized, initiated study infusions, and underwent transplantation were included in the analysis population. On day 0, all subjects had pre-transplant biopsy specimens available for analysis. On day 42, 4 subjects in the MBL-HCV1 group and 5 subjects in the placebo group had biopsy specimens available for analysis.|||Histologic activity index (HAI) score||Full Range|Median
1417276|NCT01121185|Secondary|Change in Serum HCV RNA Between Baseline and Day 3, 14, 28 and 42 Post-Transplantation|Serum HCV RNA was measured by quantitative RT-PCR. The change in HCV RNA from baseline was obtained by calculating the difference between the baseline pre-transplantation HCV RNA level and the HCV RNA level measured at each study visit.|Baseline and Day 3, 14, 28 and 42 Post-Transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||log10 IU/mL||Full Range|Median
1417277|NCT01121185|Secondary|The Incidence of Adverse Events and Treatment-Emergent Adverse Events Determined Through Medical History, Physical Examination and Laboratory Evaluation|Adverse events were assessed by targeted medical history, physical examinations and laboratory testing. Subjects were asked at scheduled study visits through day 42 whether they experienced solicited adverse reactions (fever, chills, nausea, rash, joint pain or swelling, shortness of breath, headache, fatigue, and hives). In addition to these solicited adverse events, subjects were asked at all scheduled study visits through day 56 to report any other adverse events, regardless of whether the event was thought to be related to the study infusions. Adverse events were summarized by System Organ Class (SOC) using MedDRA (version 12.0)|Through Day 56|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||events|||Number
1417278|NCT01121185|Primary|Proportion of Subjects With Detectable Serum HCV RNA at Day 42 Post-Transplantation|Serum HCV RNA was measured by Quantitative RT-PCR|At Day 42 post-transplantation|The eleven subjects who were randomized, initiated study infusions, and underwent liver transplantation were included in the analysis population.|||percentage of participants|||Number
1417279|NCT01121172|Secondary|Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents|Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group|First day after enrollment|Data were collected only from the Obese participants. Data regarding the genetic polymorphism were not collected from participants forming the Lean Arm/Group.|||participants|||Number
1417280|NCT01121172|Primary|Serum Apelin Levels|Apelin levels were measured in serum of participants, in fasting state|First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning||||ng/ml||Full Range|Median
1417281|NCT01121146|Secondary|Patient Satisfaction|"Patient satisfaction was quantified by asking participants to respond yes or no to the question, Are you satisfied with the results of your hip operation?"|Minimum 9-year follow-up|Satisfaction rates were evaluated among 84 participants with unrevised hips who had Marathon and 70 participants with unrevised hips who had Enduron polyethylene. These participants had minimum 9-year follow-up and responded to the question about satisfaction.|||percentage of participants|||Number
1417282|NCT01121146|Secondary|Harris Hip Score|The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best).|Minimum 9-year follow-up|Harris Hip Scores were evaluated for 74 unrevised hips with Marathon and 65 unrevised hips with Enduron polyethylene that had minimum 9-year follow-up and complete data to compute a score.|||score on a 100 point scale||Standard Deviation|Mean
1417283|NCT01121146|Secondary|Rate of Reoperation|The rate of reoperation was based on the number of reoperations in each group. Any additional surgery after a participant’s initial hip replacement was considered a reoperation.|10-year follow-up|All 116 hips randomized to Marathon polyethylene and all 114 hips randomized to Enduron polyethylene were included in the analysis population to determine the rate of reoperation.|||THAs|||Number
1417284|NCT01121146|Secondary|Polyethylene Wear|A single reviewer, who was blinded to the type of polyethylene liner, evaluated femoral head penetration among all unrevised hips with minimum 9-year radiographic follow-up using serial anteroposterior pelvic radiographs. Two-dimensional head penetration was determined for each follow-up radiograph relative to the immediate post-operative (nominal 6-week follow-up) reference view using Hip Suite Analysis version 8.0 with elliptical correction, a validated, computer-assisted technique. A linear wear rate was evaluated for each hip that had a minimum of three follow-up radiographs by using a least-squares linear regression to calculate the slope of the best-fit line for the wear vector magnitude versus time in situ data. The slope from this regression represented the steady-state linear wear rate. The steady-state linear wear rate data from all hips in a group was used to compute a mean polyethylene wear value.|Minimum 9-year radiographic follow-up|At least 3 head penetration measurements evaluated with Martell’s Hip Suite Analysis software were available for 76 unrevised hips with Marathon and 66 unrevised hips with Enduron polyethylene.|||millimeters per year||Standard Deviation|Mean
1417285|NCT01121146|Primary|Incidence of Clinically Significant Osteolysis|The incidence of clinically significant osteolysis was based on the number of unrevised THAs (total hip arthroplasties) with at least 1.5 square centimeters of pelvic and/or femoral osteolysis. Osteolysis was defined as an area of localized loss of trabecular bone or cortical erosion that was not apparent on the pre-operative or immediate postoperative radiograph. To obtain lesion sizes, the defects were outlined on the anteroposterior pelvic radiograph and the area of the lesion was measured using Martell's Hip Analysis Suite software. Lesions were considered clinically important if the total area of osteolysis around a hip replacement was at least 1.5 square centimeters.|Minimum 9-year radiographic follow-up|Minimum 9-year radiographs used to assess osteolysis were available for 79 unrevised hips with Marathon and 68 unrevised hips with Enduron polyethylene.|||unrevised THAs|||Number
1417286|NCT01120990|Primary|Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
1417287|NCT01120990|Primary|Diastolic Blood Pressure Measured by Tested Device.|Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
1417288|NCT01120990|Primary|Systolic Blood Pressure Measured With Mercury Sphygmomanometer.|Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
1417289|NCT01120990|Primary|Systolic Blood Pressure Measured by Tested Device.|Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.|3 months|According to the European Society of Hypertension International Protocol 2010, recruitment is continued until 33 subjects that meet the entry criteria complete all the measurements.|||mmHg||Standard Deviation|Mean
1417290|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months||||Eyes|Participants||Number
1417291|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months||||Eyes|Participants||Number
1417292|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months||||Eyes|Participants||Number
1417293|NCT01120899|Secondary|Number of Fellow Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months||||Eyes|Participants||Number
1417294|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|24 Months||||Eyes|Participants||Number
1417295|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|18 Months||||Eyes|Participants||Number
1417296|NCT01120899|Primary|Number of Study Eyes Demonstrating an Increase or Decrease in Best-corrected Visual Acuity (BCVA) of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 months||||Eyes|Participants||Number
1417310|NCT01120717|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
1417297|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|12 Months||||Eyes|Participants||Number
1417298|NCT01120899|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|"Fluorescein angiography (FA) images from both eyes in each participant were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes)in each eye using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|6 Months||||Eyes|Participants||Number
1417299|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 24 Months||||percentage change in retinal thickness|Participants|Standard Deviation|Mean
1417300|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 18 Months||||percentage change in retinal thickness|Participants|Standard Deviation|Mean
1417301|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 12 Months||||percentage change in retinal thickness|Participants|Standard Deviation|Mean
1417302|NCT01120899|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months||||percentage change|Participants|Standard Deviation|Mean
1417303|NCT01120899|Secondary|Change in BCVA in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months||||ETDRS letters|Participants|Standard Deviation|Mean
1417304|NCT01120899|Secondary|Change in BCVA in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months||||ETDRS letters|Participants|Standard Deviation|Mean
1417305|NCT01120899|Secondary|Change in BCVA in the Study Eye at 12 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 12 Months||||ETDRS Letters|Participants|Standard Deviation|Mean
1417306|NCT01120899|Secondary|Change in BCVA in the Study Eye at 6 Months Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 Months||||ETDRS Letters|Participants|Standard Deviation|Mean
1417307|NCT01120834|Primary|Overall Response Rate (ORR)|Overall Response Rate (ORR)|2 cycles||||Participants|||Count of Participants
1417308|NCT01120808|Primary|Count of Participants With Blisters||1 week|Participants with available data were analyzed|||Participants|||Count of Participants
1417309|NCT01120782|Primary|Prescription Equivalence|Number of subjects whose prescription is the same for the two lenses tested.|after 15 minutes of lens wear|All completed subjects.|||participants|||Number
1417311|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
1417312|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: sodium <125mmol/L or >160mmol/L; potassium <3.0mmol/L or >6.0mmol/L; BUN >9.99mmol/L; creatinine >176.8µmol/L; total protein (serum) <40g/L or >95g/L; albumin <25g/L; bilirubin (total) >34.2µmol/L; SGPT >3 x ULN; SGOT > 3 x ULN; gamma glutamyltransferase >3 x ULN; alkaline phosphatase (serum) >3 x ULN; glucose <2.78mmol/L or >9.99mmol/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
1417313|NCT01120717|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <115g/L, female <95 g/L; hematocrit - male <0.37v/v, female <0.32v/v; white cell count - <2.8 10E9/L or >16.0 10E9/L; platelets - <75 10E9/L or >700 10E9/L|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with the required data were included in this analysis.|||participants|||Number
1417314|NCT01120717|Secondary|Pre-dose FEV1|Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.|52 weeks|Full analysis set - all randomized patients who received at least one dose of study drug. Only patients with the required data were included in this analysis.|||Liter||Standard Error|Least Squares Mean
1417315|NCT01120717|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks + Follow-up (Up to Day 394)|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis.|||participants|||Number
1417316|NCT01120704|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (52 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.~Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 52 Self-Reported 7-Day Point-Prevalence Abstinence."|Assessed at 52 weeks after target quit day||||participants|||Number
1417317|NCT01120704|Secondary|Latency to Relapse|Latency to Relapse during the first 12 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored|Assessed during the first 12 months post-quit after target quit day||||participants|||Number
1417318|NCT01120691|Secondary|St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, Forced Expiratory Volume in 1 Second (FEV1) prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates. SGRQ total score is the sum of the scores from the three components; symptoms, activity and impacts.|12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.|||units on a scale||Standard Error|Least Squares Mean
1417319|NCT01120691|Secondary|Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set(mFAS)included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis|||percentage of days||Standard Error|Least Squares Mean
1417320|NCT01120691|Secondary|Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period|The severe or less FEV1 % predicted (post bronchodilator)>=30%; very severe=> FEV1 % predicted(the post bronchodilator)<30%.Number of puffs of rescue medication taken in the previous 12 hours was recorded in patient diary in the morning and in the evening for 26 weeks.The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient.Rescue medication data recorded during the 14 day run-in was used to calculate the baseline.A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates.|Baseline (14 day run-in), 64 weeks|Modified Full Analysis Set mFAS included all patients in the Full analysis set except patients from a site,which had major issues with GCP compliance. The Full Analysis Set includes all randomized patients who received at least one dose of study drug and data was available for analysis. Patients with evaluable data were included in this analysis|||# puffs||Standard Error|Least Squares Mean
1417321|NCT01120691|Secondary|Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.~Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis"|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.|||L (liters)||Standard Error|Least Squares Mean
1417322|NCT01120691|Secondary|Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium|"Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards.~Spirometry measurements taken were FEV1 at -45 minutes and -15 minutes pre-dose. Three acceptable maneuvers had to be performed for each time point. The FEV1 values recorded had to be the highest values measured irrespective of whether or not they occurred on the same curve.~The mixed model for analysis contained treatment as a fixed effect with average of the 45 minutes and 15 minutes pre dose FEV1 measurements at day 1 as the baseline measurement, FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at -14 Day) as covariates."|4, 12, 26, 38, 52 and 64 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis. Each category has patients with assessable data at that particular time.|||L (liters)||Standard Error|Least Squares Mean
1417323|NCT01120691|Secondary|Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points|Cumulative rates were estimated using Anderson and Gill method. Chronic Obstructive Pulmonary Disease (COPD) exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|26, 52, 64, 76 weeks|Modified Full Analysis Set(mFAS) included all patients in the Full Analysis Set (FAS) except patients from a site, which had major issues with GCP compliance. FAS include all randomized patients who received at least one dose of study drug and data was available for analysis.|||exacerbations per year|Participants|95% Confidence Interval|Number
1417324|NCT01120691|Secondary|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period|Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized|||percentage of participants|||Number
1417325|NCT01120691|Secondary|Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.|Time to Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.|64 weeks|Modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues. The Safety set includes all patients who received at least one dose of study drug whether or not being randomized. Analysis population included patients with study withdrawal or premature discontinuation for any reason.|||days||95% Confidence Interval|Median
1417326|NCT01120691|Secondary|Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics|The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site with GCP non-compliance. This is a sub-group analysis with mutually exclusive population in each category for analysis.|||Days||Standard Deviation|Mean
1417488|NCT01120093|Primary|Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment||Day 7|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1417327|NCT01120691|Secondary|Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics|Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and data was available for analysis.|||exacerbations per year|Participants||Number
1417328|NCT01120691|Secondary|Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance. Only patients with a moderate or severe COPD exacerbation were included in this analysis.|||days||95% Confidence Interval|Median
1417329|NCT01120691|Secondary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|76 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site, which had major issues with GCP compliance.|||Exacerbations per year|Participants||Number
1417330|NCT01120691|Primary|Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization.~Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years"|64 weeks|Modified Full Analysis Set (mFAS) included all patients in the Full analysis set except patients from a site , which had major issues with Good Clinical Practice (GCP) compliance.|||Exacerbations per year|Participants||Number
1417331|NCT01120626|Secondary|Aberrant Behavior Checklist (ABC)|The Aberrant Behavior Checklist is a 58-item symptom checklist for assessing problem behaviors. The ABC was rated by each participant's parent. Each item is rated on a four-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). The ABC Total score (range 0-174) is the sum of all individual item scores. Higher score indicates more maladaptive behaviors/worse outcome.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 39 of 42 participants were administered the ABC at week 12.|||units on a scale||Standard Deviation|Mean
1417332|NCT01120626|Primary|Contingency Naming Test (CNT) Performance Score|Week 12 Contingency Naming Test (CNT) performance score on Rule 2 (naming shapes) and on Rule 3 (If the inside shape matches the outside shape, name the color, otherwise, name the outside shape). Performance score is the number of correct responses per minute, calculated by dividing the number of correct responses by the time taken to complete the 27 items, and multiplying by 60. Higher scores indicate faster and more accurate responding.|Week 12|41 of 42 randomized participants completed the 12-week randomized controlled trial. 37 of 42 randomized participants completed CNT Rule 2 at week 12. 34 of 42 randomized participants completed CNT Rule 3 at week 12.|||correct responses per minute||Standard Deviation|Mean
1417333|NCT01120600|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 24 months after first dose of study drug|All randomized participants who took at least one dose of study drug|||Participants|||Number
1417334|NCT01120600|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 24 months (plus 14 days) after first dose of study drug|All randomized participants who took at least one dose of study drug|||Participants|||Number
1417335|NCT01120600|Secondary|Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24|Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-P1NP data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1418032|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI||1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
1417337|NCT01120600|Secondary|Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24|Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available U-NTx/Cr data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1417338|NCT01120600|Secondary|Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24|Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who had no important deviations from the protocol that may have substantially affected the results, and had available s-CTx data for Baseline and Week 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1417339|NCT01120600|Secondary|Percentage Change From Baseline in Trochanter BMD at Month 24|Trochanter BMD was assessed by DXA at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available trochanter BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1417340|NCT01120600|Secondary|Percentage Change From Baseline in Femoral Neck BMD at Month 24|Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available femoral neck BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1417341|NCT01120600|Secondary|Percentage Change From Baseline in Total Hip BMD at Month 24|Total hip BMD was assessed by DXA at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available total hip BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1417342|NCT01120600|Primary|Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24|Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.|Baseline and Month 24|All randomized participants who took at least one dose of blinded study treatment and had available lumbar spine BMD data for Baseline and Month 24|||Percentage change||95% Confidence Interval|Least Squares Mean
1417343|NCT01120405|Secondary|Urine Output|Urine volume in milliliter (mL) during the first postoperative hours|From Day 0 until Postoperative Day 1|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||mL||Standard Deviation|Mean
1417344|NCT01120405|Secondary|Number of Participants With Chest Pain During the 3 Postoperative Days|Patients with Chest Pain reported at least once per day during the 3 Postoperative Days|From Day 0 until Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||participants|||Number
1417345|NCT01120405|Secondary|Vital Signs (Heart Rate Changes)|Changes from baseline for Heart Rate (HR)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||beats per minute||Standard Deviation|Mean
1417346|NCT01120405|Secondary|Vital Signs (SBP and DBP Changes)|Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)|From pre-induction to Postoperative Day 3|Treated set (TS): Randomised patients who received the study medication. Patients were assigned to the treatment groups as treated, i.e. the treatment groups were based on the treatment actually received.|||mm Hg||Standard Deviation|Mean
1417347|NCT01120405|Secondary|Systolic Blood Pressure (SBP)|Repeated Systolic Blood Pressure measurements during the perioperative period|From pre-induction to recovery of anesthesia|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||mm Hg||Standard Deviation|Mean
1417348|NCT01120405|Secondary|Number of Participants With Composite Endpoint|Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
1417349|NCT01120405|Secondary|Number of Participants Who Died From Cardiac Origin|No patient died from a cardiac cause during the 3 postoperative days.|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
1417350|NCT01120405|Secondary|Number of Participants With Life-Threatening Arrhythmia|Patients with Life-Threatening Arrhythmia in the FAS|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
1417351|NCT01120405|Secondary|Number of Participants With Cerebro-Vascular Event|Patients with Cerebro-Vascular Event in the FAS|3 postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
1417352|NCT01120405|Secondary|Number of Participants With Myocardial Infarction (MI)|Patients with Confirmed Myocardial Infarction (MI) by the Investigators|3 Postoperative Days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
1417367|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417353|NCT01120405|Secondary|Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)|At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)|3 Postoperative days|Full analysis set (FAS): Randomised patients who started general anaesthesia induction. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
1417354|NCT01120405|Primary|Number of Participants With Myocardial Necrosis (MN)|Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)|3 Postoperative Days|Per protocol set (PPS): Randomised patients who started general anaesthesia induction and with no major protocol violations. Patients were assigned to the treatment groups as randomised, i.e. the treatment groups were based on the treatment allocated by randomisation.|||participants|||Number
1417355|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 4-year visit is 1502 days.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants|||Number
1417356|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 3-year visit is 1053-1137 days.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants|||Number
1417357|NCT01120379|Secondary|Dual Antiplatelet Medication Usage|Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 2-year visit is 688-772 days.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants|||Number
1417358|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417359|NCT01120379|Secondary|Major Bleeding Complications (Site Reported)|Major bleeding complications consisted of CEC-adjudicated TIMI major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417360|NCT01120379|Secondary|Major Bleeding Complications|Major bleeding complications consisted of Clinical Events Committee (CEC)-adjudicated Thrombolysis In Myocardial Infarction (TIMI) major bleeding through 2-year follow-up and site reported major bleeding after 2 years.|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417361|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417362|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417363|NCT01120379|Secondary|Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417364|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417365|NCT01120379|Secondary|Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417368|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417369|NCT01120379|Secondary|Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417370|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417371|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417372|NCT01120379|Secondary|Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417373|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417374|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417375|NCT01120379|Secondary|Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417376|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417377|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417378|NCT01120379|Secondary|Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417379|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417712|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
1417380|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417381|NCT01120379|Secondary|Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417382|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417383|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).||3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417384|NCT01120379|Primary|Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).||2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417385|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) as Defined by ARC|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|4 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417386|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|3 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417387|NCT01120379|Primary|Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|2 years|Number of participants analyzed excludes patients who are truly lost-to-follow-up, defined as patients who are lost to follow-up through given timepoint without any ARC Defined Patient-Oriented Endpoint (all death, all MI, all revascularization, respectively). Number of participants analyzed includes patients with valid data at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
1417404|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|Week 8||||participants|||Number
1424566|NCT01059760|Primary|Change From Baseline in Participant Bicarbonate When Fasting and Fed||Baseline and 3 days||||mmol/L||Standard Deviation|Mean
1417388|NCT01120275|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated at least every 3 weeks at the beginning of each cycle, up to 3 years|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1417389|NCT01120275|Secondary|Percentage of Participants With Confirmed and Unconfirmed Complete or Partial Response|Complete disappearance of all measurable and non-measurable disease, or greater than or equal to 30% decrease under baseline of the sum of the longest diameters of all target measurable lesions.|Disease assessments for response were performed every 6 weeks, up to 3 years||||portation of participants||95% Confidence Interval|Number
1417390|NCT01120275|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years.||||Months||95% Confidence Interval|Median
1417391|NCT01120275|Primary|Progression-free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.|Disease assessments were performed every 6 weeks, up to 3 years.||||Months||95% Confidence Interval|Median
1417392|NCT01120236|Other Pre-specified|Change in Level of Insulin|Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (insulin) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.|Baseline to 12 weeks||||ulU/mL||Standard Deviation|Mean
1417393|NCT01120236|Other Pre-specified|Change in Level of IGFBP2, IGFBP3 and Growth Hormone|Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited to: IGFBP2, IGFBP3 and Growth Hormone) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.|Baseline to 12 weeks||||pg/mL||Standard Deviation|Mean
1417394|NCT01120236|Other Pre-specified|Change in Level of IGF-I, Free IGF-I and C-peptide|Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited to: IGF-I, free IGF-I and C-peptide) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.|Baseline to 12 weeks||||ng/mL||Standard Deviation|Mean
1417395|NCT01120236|Secondary|Change in Level of CTCs|Will be correlated with 28-week PSA response.|Baseline to 28 weeks|Among the 50 patients in this biomarker substudy, 1 was ineligible for the trial, 6 started LHRH therapy prior to registration, and 4 had CTC blood samples that were not assay evaluable. The remaining 39 patients were included in this analysis.|||Participants|||Count of Participants
1417396|NCT01120236|Secondary|Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts|The Friedman test will be used to evaluate correlations between microRNA measures (CT) and Baseline CTCs.|Baseline|Among the 50 patients in this biomarker substudy, 14 patients were excluded: 1 ineligible for S0925, 6 started LHRH therapy prior to registration, 3 had insufficient miRNA samples and 4 had insufficient CTC samples. The remaining 36 patients were used in this analysis.|||Cycle Threshold (CT)||Full Range|Median
1417397|NCT01120236|Secondary|Correlation of microRNA Measures With 28-week PSA Response|The Friedman test will be used to evaluate correlations between microRNA measures (CT) and 28-week PSA response.|Baseline to 28 weeks|Among the 50 patients in this biomarker substudy, 10 patients were excluded: 1 ineligible for S0925, 6 started LHRH therapy prior to registration, 3 had insufficient miRNA samples. The remaining 40 patienets were included in this analysis.|||Cycle Threshold (CT)||Full Range|Median
1417398|NCT01120236|Secondary|Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)|The logistic regression algorithm for predicting undetectable PSA that was developed for SWOG-9346 using its baseline risk factors (age at registration, performance status, baseline PSA, and bone pain) will be applied to each arm of this trial to evaluate the level of agreement between the observed and predicted undetectable PSA rates.|Up to 5 years|The data from this trial was intended to be used as a validation dataset for the prognostic model built using data from SWOG-9346. However, data for this objective was not collected.||||||
1417399|NCT01120236|Secondary|Proportion of Patients Who do Not Achieve a Partial PSA Response|A partial PSA response is considered <= 4 ng/mL|Up to 5 years|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.|||participants|||Number
1417400|NCT01120236|Secondary|Toxicity|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 28 weeks|All participants receiving at least some protocol treatment were included in toxicity analysis. Four patients on Arm I (androgen deprivation and cixutumumab) and two patients on Arm II (androgen deprivation therapy) did not receive any protocol treatment and were therefore excluded from this analysis.|||Participants|||Number
1417401|NCT01120236|Primary|Undetectable PSA Rate|Undetectable PSA rate (<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment|7 months|One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.|||participants|||Number
1417402|NCT01120223|Secondary|Withdrawal|"How many subjects withdrew from the study. Reasons for withdrawal:~due to exclusion criteria emerging, due to AE(s), or due to other reason"|Week 4 and 8||||participants|||Number
1417403|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment (up to 8 weeks)||||participants|||Number
1424567|NCT01059760|Primary|Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed||Baseline and 3 days||||fL||Standard Deviation|Mean
1417406|NCT01120223|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|Week 2||||participants|||Number
1417407|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and End of treatment (up to 8 weeks)||||percent of change||Standard Deviation|Mean
1417408|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8||||percent change||Standard Deviation|Mean
1417409|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points.|Baseline and week 4||||percent of change||Standard Deviation|Mean
1417410|NCT01120223|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 2||||percentage of change||Standard Deviation|Mean
1417411|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at End of Treatment|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment|End of treatment (up to 8 weeks)||||participants|||Number
1417412|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment|Change in urinary calcium:creatinine ratio from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)||||mmol/g||Standard Deviation|Mean
1417413|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8|Change in urinary calcium:creatinine ratio from Baseline to week 8|Baseline and week 8||||mmol/g||Standard Deviation|Mean
1417414|NCT01120223|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4|Change in urinary calcium:creatinine ratio from Baseline to week 4|Baseline and week 4||||mmol/g||Standard Deviation|Mean
1417415|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment|Change in 24-hour urinary calcium excretion from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)||||mmol/24hr||Standard Deviation|Mean
1417416|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8|Change in 24-hour urinary calcium excretion from Baseline to week 8|Baseline and week 8||||mmol/24hr||Standard Deviation|Mean
1417417|NCT01120223|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4|Change in 24-hour urinary calcium excretion from Baseline to week 4|Baseline and week 4||||mmol/24hr||Standard Deviation|Mean
1417418|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to End of Treatment|Change in albumincorrected serum calcium from Baseline to end of treatment|Baseline and End of treatment (up to 8 weeks)||||mmol/L||Standard Error|Mean
1417419|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 8|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8|Week 8||||participants|||Number
1417420|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 4|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4|Week 4||||participants|||Number
1417421|NCT01120223|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Week 2|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|Week 2||||participants|||Number
1417422|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 8|Change in plasma PTH (parathyroid hormone) from Baseline to week 8|Baseline and week 8||||ng/L||Standard Deviation|Mean
1417423|NCT01120223|Secondary|Change in Plasma PTH From Baseline to Week 4|Change in plasma PTH (parathyroid hormone) from Baseline to week 4|Baseline and week 4||||ng/L||Standard Deviation|Mean
1417424|NCT01120223|Primary|Change in Albumincorrected Serum Calcium From Baseline to Week 8|Change in albumincorrected serum calcium from Baseline to week 8|Baseline and week 8||||mmol/L||Standard Deviation|Mean
1417427|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Calculated Systemic Vascular Resistance (SVR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Calculated Systemic Vascular Resistance (SVR) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||dyn.s.cm-5||Standard Error|Least Squares Mean
1417428|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Diastolic Pressure (PADP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Square (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
1417429|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Arterial Systolic Pressure (PASP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Pulmonary Arterial Systolic Pressure (PASP) at the end of 5, 15 and 30 ng/kg/min Infusions as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
1417430|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Stroke Volume (SV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Stroke Volume (SV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mL/beat||Standard Error|Least Squares Mean
1417431|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Fractional Shortening (FS)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Fractional Shortening (FS) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||percentage||Standard Error|Least Squares Mean
1417432|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular Ejection Fraction (LVEF)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular Ejection Fraction (LVEF) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||percentage||Standard Error|Least Squares Mean
1417433|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of 30 ng/kg/Min Infusion]) in Left Ventricular End Diastolic Volume (LVEDV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in Left Ventricular End Diastolic Volume (LVEDV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mL||Standard Error|Least Squares Mean
1424568|NCT01059760|Primary|Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed||Baseline and 3 days||||% of SD of MCV to mean MCV||Standard Deviation|Mean
1417434|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 3-hours Post Infusion Initiation [ie, at the End of the 30 ng/kg/Min Infusion]) in Left Ventricular End Systolic Volume (LVESV)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min infusion as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mL||Standard Error|Least Squares Mean
1417435|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Diastolic Blood Pressure (DBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of LS mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in Least Square (LS) means (and associated confidence intervals) for change from Baseline in diastolic blood pressure(DBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
1417436|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Systolic Blood Pressure (SBP)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in systolic blood pressure (SBP) at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
1417437|NCT01120210|Secondary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Heart Rate (HR)|The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in heart rate (HR) at each time point as well as treatment group LS means and Standard Errors.|At 1-hour, 2 hours and 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1417438|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Pulmonary Capillary Wedge Pressure (PCWP)|The effect of JNJ-39588146 on pulmonary capillary wedge pressure (PCWP) was evaluated by administering multiple ascending doses of JNJ-39588146 or placebo over a 3-hour intravenous (IV) infusion period to patients with heart failure. The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from baseline in PCWP at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||mmHg||Standard Error|Least Squares Mean
1417439|NCT01120210|Primary|Post-baseline Changes Compared to Placebo (at 1-, 2-, and 3-hours Post Infusion Initiation [ie, at the End of 5, 15 and 30 ng/kg/Min Infusions]) in Cardiac Index (CI)|The effect of JNJ-39588146 on cardiac index (CI), a hemodynamic parameter that relates heart performance to the size of the individual measured in liters per minute per square metre (l/min/m2) was evaluated in patients with heart failure (HF). The primary analysis of this study focused on the differences between the treatment groups in terms of Least Squares (LS) mean change from Baseline at each time point; thus, the results provided below consist of the JNJ-39588146 minus placebo differences in LS means (and associated confidence intervals) for change from Baseline in CI at each time point as well as treatment group LS means and Standard Errors.|Baseline up through 3 hours post infusion initiation|The modified intent-to-treat (MITT) population included all randomized patients who received at least 1 dose of study drug, had baseline measurement and at least 1 post-baseline measurement value of at least 1 of the primary endpoints. The efficacy analysis was to be performed using the MITT analysis set.|||L/min/m2||Standard Error|Least Squares Mean
1417440|NCT01120197|Secondary|Falls-Efficacy Scale-International|A 16- item self report or interview- based questionnaire assessing the fear of falling during basic and more demanding activities of daily living (Yardley et al. 2005). Each item is scored on a four point scale. Minimun score indicating low concern about falling is 16. The maximun score indication high concern about falling is 64.|Baseline, 3 months follow-up, 12 months follow up|||||||
1417441|NCT01120197|Secondary|General Health Questionnaire 20 (GHQ20).|GHQ-20 is a generic instrument and registers distress and psychopathology. GHQ-20 is self-administered and the answers to each item may be treated as a “Likert Scale” and have weights assigned to each position (0-1-2-3) where 0 is no distress, and 3 is severe distress. This gives a possible range for the total GHQ-20 score of 0-60. Higher scores indicating poor qol.|At baseline, 3 and 12 months after baseline||||units on a scale||Standard Deviation|Mean
1417442|NCT01120197|Secondary|QUALEFFO 41|"Quality of Life Questionnaire issued by the European Foundation for Osteoporosis (QUALEFFO-41), is a disease-specific questionnaire to be used by patients with vertebral fractures attributed to osteoporosis. QUALEFFO-41 is self-administered and contains questions in five domains: pain, ability to perform physical functions, social functioning, general health perception and mental performance. These five domains can be evaluated individually or be represented in a total score. All scores in all the domains are expressed in values ranging from 0-100, where 0 represents the best and 100 the worst. The total QALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100.~High scores indicate poor quality of life."|At baseline, 3 and 12 months after the baseline||||units on a scale||Standard Deviation|Mean
1417443|NCT01120197|Secondary|Functional Reach|"The maximum distance in centimetres that can be reached forward in a standing position while maintaining a fixed base of support. Subjects will be instructed to stand sideways against a wall in a natural position and stretch one arm forward level with the shoulder. The position of the third metacarpophalangeal (MCP) joint was taken as the zero point. With the body tilted forward as far as possible, the subjects continued to stretch the arm parallel to the ground.~Amount of cm indicate better balance."|At baseline, 3 and 12 months after the baseline||||Centimetres||Standard Deviation|Mean
1417444|NCT01120197|Secondary|Timed Up & Go Test (TUG)|The subject will be instructed to rise from a chair with a seat height of 43 cm, walk 3 m, turn around, return and sit down again, wearing ordinary footwear and use customary walking aids if necessary.|At baseline, 3 and 12 months after the baseline.||||Seconds||Standard Deviation|Mean
1417445|NCT01120197|Primary|Time Used to Walk 20 m at Maximal Speed.|Times (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded|At baseline, 3 and 12 months after the baseline||||Seconds||Standard Deviation|Mean
1417446|NCT01120184|Secondary|OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels|"OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis. Reported upper bound of confidence interval for Trastuzumab Emtansine + Placebo and confidence interval values for Trastuzumab + Taxane and Trastuzumab Emtansine + Pertuzumab are censored values."|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (Low HER2 mRNA Subpopulation).|||months||Full Range|Median
1417447|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (Low HER2 mRNA Subpopulation).|||percentage of participants|||Number
1417448|NCT01120184|Secondary|OS at Clinical Cutoff Among Those With High HER2 mRNA Levels|OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (High HER2 mRNA Subpopulation).|||months||Full Range|Median
1417449|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population (High HER2 mRNA Subpopulation).|||percentage of participants|||Number
1417450|NCT01120184|Secondary|PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation).|||months||Full Range|Median
1417451|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation).|||percentage of participants|||Number
1417452|NCT01120184|Secondary|PFS According to IRF Assessment Among Those With High HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation).|||months||Full Range|Median
1424569|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed||Baseline and 3 days||||g/dL||Standard Deviation|Mean
1417453|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation).|||percentage of participants|||Number
1417454|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (Low HER2 mRNA Subpopulation): All randomized participants with below-the-median HER2 mRNA expression (value less than or equal to [≤] 59.71). Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants|||Number
1417455|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population (High HER2 mRNA Subpopulation): All randomized participants with above-the-median HER2 mRNA expression (value greater than [>] 59.71). Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants|||Number
1417456|NCT01120184|Secondary|Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score|The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect).|Baseline, Cycle 7 (Week 18)|Number of participants analysed=participants from ITT population who reported conduct of daily activities. Here, 'n' signifies the number of participants with available data at specified category.|||units on a scale||95% Confidence Interval|Mean
1417457|NCT01120184|Secondary|Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score|The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment. The reported changes represent change from baseline at Cycle 7. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect)|Baseline, Cycle 7 (Week 18)|Number of participants analysed=participants from ITT population who were employed at baseline. Here, 'n' signifies the number of participants with available data at specified category.|||percent of work||95% Confidence Interval|Mean
1417458|NCT01120184|Secondary|Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score|The RSCL is a self-reported instrument which consists of 4 domains including physical symptom distress, psychological distress, activity level, and overall global life quality. Only the activity level scale was collected and assessed. Scores may range from 0 to 100, with higher scores indicating increased burden of disease. Mean RSCL activity scale score changes were calculated as [mean score at the assessment visit minus mean score at Baseline]. The higher the score, the higher the level of impairment or burden.|Baseline, Cycle 7 (Week 18)|ITT Population. Here, 'n' signifies the number of participants with available data at baseline and Cycle 7 (Week 18).|||units on a scale||95% Confidence Interval|Mean
1417491|NCT01119963|Primary|Gestational Age at Delivery|Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.|Measured from day of last menstrual cycle to day of birth and measured in weeks.|Intent to treat population (included all participants who were randomized, whether they received study medication or not).|||weeks.||Standard Deviation|Mean
1417459|NCT01120184|Secondary|Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score|The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.|||months||95% Confidence Interval|Median
1417460|NCT01120184|Secondary|Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score|The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. The percentage of participants with deterioration was calculated as [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100.|Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)|ITT Population. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.|||percentage of participants|||Number
1417461|NCT01120184|Secondary|Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module|The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with diarrhea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.|At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2|ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.|||percentage of participants|||Number
1417462|NCT01120184|Secondary|Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module|The FACT-C is a self-reported instrument which measures HRQOL pertaining to colorectal cancer. Response options on each question may range from 0 (not at all) to 4 (very much). The percentage of participants with nausea was calculated using following formula: [number of participants with any level of either symptom divided by the number analyzed] multiplied by 100.|At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2|ITT Population (Protocol Amendment C Subpopulation). Only participants with a FACT-C score at the designated visit (n) were included in the analysis.|||percentage of participants|||Number
1417463|NCT01120184|Secondary|Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score|The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: [number of participants meeting the above threshold divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)|ITT Population (Protocol Amendment C Subpopulation): All randomized participants who entered the study after Protocol Amendment C.|||percentage of participants||95% Confidence Interval|Number
1417464|NCT01120184|Secondary|Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient (20%) increase to qualify for disease progression. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR, PR, or SD was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|Data were not analyzed. Protocol Amendment E removed this outcome measure as a secondary endpoint, because it was redundant to another prespecified secondary endpoint.||||||
1417489|NCT01120067|Primary|McGill Pain Questionnaire|McGill Pain Questionnaire (MPQ; Melzack, 1975): is a self-report questionnaire consisting of 102 words separated into three major classes; the sensory, affective, and evaluative aspects of pain. Respondents are asked to circle the word that best describes their pain. The stability, reliability, and validity of the MPQ have been established (Reading, Everitt, & Sledmere, 1982). The MPQ total score ranges from 0 to 78 with higher values indicating more significant pain.|6 months||||units on a scale||Standard Deviation|Mean
1417465|NCT01120184|Secondary|Duration of Response According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Duration of response was defined as the time from confirmed PR or CR to first documented disease progression or death from any cause. CR was defined as the disappearance of all target lesions and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. Median duration of response was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population. Only participants achieving CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1417466|NCT01120184|Secondary|Percentage of Participants With Objective Response According to Investigator Assessment|Objective response was defined as having CR or PR, assessed according to RECIST version 1.1, by investigator. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the ORR) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
1417467|NCT01120184|Secondary|Percentage of Participants With Objective Response According to IRF Assessment|Objective response was defined as having complete response (CR) or partial response (PR), assessed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to <10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate [ORR]) was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact method.|Up to 46 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population. Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1417468|NCT01120184|Secondary|Percentage of Participants With Hospitalization|Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|Safety population|||percentage of participants||95% Confidence Interval|Number
1417469|NCT01120184|Secondary|Hospitalization Days|Hospitalization was defined as a non-administration-related hospitalization due to serious adverse event, while on study treatment. Reported values represent number of days admitted per participants.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|Safety population. Number of participants analyzed=participants with hospitalization and data available for calculation of the parameter.|||days||Full Range|Median
1417470|NCT01120184|Secondary|Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status is a scale used to quantify cancer participants' general well-being and activities of daily life. The scale ranges from 0 to 5, with 0 denoting perfect health and 5 indicating death. The 6 categories are 0=Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1=Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2=Symptomatic, < 50% in bed during the day (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours), 3=Symptomatic, > 50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours), 4=Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair), 5=Death.|Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months)|Safety population|||percentage of participants|||Number
1417471|NCT01120184|Secondary|Percentage of Participants With Grade 3-4 Laboratory Parameters|Laboratory results were graded according to NCI CTCAE version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.|Day 1, 8, and 15 of Cycle 1–3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014|Safety population. Number of participants analyzed=participants with available data for the outcome.|||percentage of participants|||Number
1417472|NCT01120184|Secondary|Percentage of Participants With Grade 5 Adverse Events|Adverse events were graded according to NCI CTCAE version 4.0. Grade 5 adverse events are those events which led to death.|Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose)|Safety population|||percentage of participants|||Number
1417473|NCT01120184|Secondary|Overall Survival Truncated at 2 Years|Overall Survival truncated at 2 years was defined as the percentage of participants alive at 2 years.|From randomization until 2 years|ITT Population.|||percentage of participants|||Number
1417474|NCT01120184|Secondary|Percentage of Participants Who Died at 2 Years||From randomization until 2 years|ITT Population|||percentage of participants|||Number
1419274|NCT01105130|Secondary|Retention|Retention is the percentage of participants who complete the 8 week visit.|8 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1417475|NCT01120184|Secondary|Percentage of Participants With Grade ≥3 Adverse Events|Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival. Grade 5: Death.|Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose|Safety Population: All treated participants. Additionally, 2 participants randomized to trastuzumab+taxane received 3 cycles of trastuzumab emtansine and were included in trastuzumab emtansine+placebo arm. 6 participants randomized to trastuzumab emtansine+placebo received pertuzumab and were included in trastuzumab emtansine+pertuzumab arm.|||percentage of participants|||Number
1417476|NCT01120184|Secondary|One-Year Survival Rate|The percentage of participants alive at 1 year after randomization was estimated as the one-year survival rate using Kaplan-Meier analysis, and corresponding CIs were computed using Greenwood's estimate of the standard error.|From randomization until 1 year|ITT Population.|||percentage probability of being alive||95% Confidence Interval|Number
1417477|NCT01120184|Secondary|Time to Treatment Failure (TTF)|Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. TTF was defined as the time from randomization to treatment failure. Median TTF was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population.|||months||95% Confidence Interval|Median
1417478|NCT01120184|Secondary|Percentage of Participants Experiencing Treatment Failure|Treatment failure was defined as the discontinuation of all study medications in the treatment arm for any reason including disease progression, treatment toxicity, death, physician decision, or participant withdrawal. The percentage of participants with treatment failure was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014|ITT Population.|||percentage of participants|||Number
1417479|NCT01120184|Secondary|PFS According to Investigator Assessment|Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||months||95% Confidence Interval|Median
1417480|NCT01120184|Secondary|Percentage of Participants With Death or Disease Progression According to Investigator Assessment|Tumor assessments were performed by the investigator according to RECIST version 1.1. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||percentage of participants|||Number
1417481|NCT01120184|Secondary|Overall Survival (OS) at Clinical Cutoff|OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population.|||months||95% Confidence Interval|Median
1417482|NCT01120184|Secondary|Percentage of Participants Who Died Prior to Clinical Cutoff|The percentage of participants who died prior to clinical cutoff was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)|ITT Population.|||percentage of participants|||Number
1417483|NCT01120184|Primary|Progression-Free Survival (PFS) According to IRF Assessment|Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||months||95% Confidence Interval|Median
1417484|NCT01120184|Primary|Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment|Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)|ITT Population.|||percentage of participants|||Number
1424570|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed||Baseline and 3 days||||pg||Standard Deviation|Mean
1417492|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity on Days 1, 7 and 14|"Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. (see Outcome Measure #23).~Trough FVC was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417493|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417494|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417495|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417496|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417497|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time.|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417498|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4 hours (postdose) on days 1, 7 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417499|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14 of treatment. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417500|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Trough FEV1 was measured on Days 1, 7 and 14 of treatment. Trough FEV1 was defined as the mean of the FEV1 values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|23 hours 15 mins and 23 hours 45 mins post-dose on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417656|NCT01119443|Primary|AUCτ,ss (Fed Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng·h/mL||Standard Deviation|Geometric Mean
1417501|NCT01119950|Other Pre-specified|Trough Forced Vital Capacity After 28 Days of Treatment|Forced Vital Capacity (FVC) after 28 days of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. Trough FVC was defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose.|23 hours 15 mins and 23 hours 45 mins post-dose on Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417502|NCT01119950|Other Pre-specified|Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time. Measurements were taken at 25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28."|25 min , 15 min pre-dose, 5 min, 15 min, 1 , 2 ,3 , 4 , 6 , 8 , 10 hours , 11 hour 55 min and 14 hour post-dose on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417503|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second at 12 Hours on Day 28 of Treatment|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417504|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours)|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at: 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose). FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417505|NCT01119950|Other Pre-specified|Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~FEV1 Area Under the Curve (AUC) measurements were taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28. FEV1 AUC was calculated as the sum of trapezoids divided by the length of time."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417506|NCT01119950|Other Pre-specified|Trough Forced Expiratory Volume in One Second by Treatment at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Spirometry was performed according to internationally accepted standards.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||Standard Deviation|Mean
1417507|NCT01119950|Primary|Maximal Response of Incremental Once Daily and Twice Daily Doses of NVA237 That Each Dose Achieves in Relation to the Maximal Effect of NVA237 on Trough Forced Expiratory Volume in One Second at Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. The maximal response of incremental once daily and twice daily doses of NVA237 that each dose achieves in relation to the maximal effect of NVA237 on Trough FEV1 was measured at Day 28. FEV1 was measured in response to all doses administered (see Outcome Measure #19).~All trough FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All trough FEV1 data are reported as a percentage of the theoretical maximal response.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1417508|NCT01119950|Secondary|Mean Daily Use of Rescue Medication by Treatment at Different Time Points|Mean daily use of rescue medication by treatment and time points. Baseline was defined as the average of the total number of puffs of rescue medication during the week prior to treatment start, divided by the total number of days with non-missing rescue data during that week, then puffs were counted during weeks 1, 2, 3 and 4 postdose.|Baseline, Weeks 1, 2, 3 and 4|Only patients with a non-missing value at both period baseline and the respective post-baseline visit were included. The modeling approach is not suitable for these data as the modeling assumptions do not hold.|||Number of Puffs||Standard Deviation|Mean
1417509|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Vital Capacity on Days 1, 7 and 14|"Percentage of the maximal response of NVA237 Doses on Trough Forced Vital Capacity (FVC) on Days 1, 7 and 14. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was assessed via spirometry. (see Outcome Measure #33).~Trough FVC is defined as the mean of the FVC values measured at 23 hours 15 mins and 23 hours 45 mins post-dose."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1424571|NCT01059760|Primary|Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed||Baseline and 3 days||||fL||Standard Deviation|Mean
1417510|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 doses on Peak FEV1 was measured on days 1, 7 and 14 of treatment.~Peak FEV1 was measured in response to all doses administered (see Outcome Measure #32). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1, 7, and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1417511|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 at 12 hours was measured on days 1 and 14.~FEV1 was measured in response to all doses administered (see Outcome Measure #31). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1417512|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 12-24 Hours Over Days 1, and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 on FEV1 Area under the curve (AUC) 12-24 hours was calculated from measurements taken at 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #30). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on Days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
1417513|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-12 Hours at Day 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses was calculated on FEV1 Area Under the Curve (AUC) 0-12 hours from measurements taken at at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14 in response to all doses administered (see Outcome Measure #29).~All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11h 55 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
1417514|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second of Area Under the Curve 0-8 Hours Days 1, 7, and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-8 was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7, and 14.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #28). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|at 5 min,15 min, 1,2,3,4,6,8 hours (postdose) on days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
1417515|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-4 Hours on Days 1, 7 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 hours was calculated from measurements taken at 5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14, in response to all doses administered (see Outcome Measure #27).~All AUC FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4 hours (postdose) on Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
1417530|NCT01119937|Secondary|Change in St. George Respiratory Questionnaire From Baseline|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.|Weeks 12, 24, 36, 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.|||score on a scale||Standard Deviation|Mean
1417516|NCT01119950|Secondary|Percentage of the Maximal Effect of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours on Days 1 and 14 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours, was calculated from measurements taken at 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14.~FEV1 AUC 0-24 hours was measured on days 1 and 14 of treatment in response to all doses administered (see Outcome Measure #26). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on days 1 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
1417517|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Trough Forced Expiratory Volume in One Second at Days 1, 7 and 14|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response of NVA237 doses on Trough FEV1 was measured on Days 1, 7 and 14.~Through FEV1 was measured in response to all doses administered (see Outcome Measure #25). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response.~Trough FEV1 was defined as the mean of the 23 hour 15 minute and 23 hour 45 minute post-dose values."|Days 1, 7 and 14|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1417518|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Vital Capacity at Day 28 of Treatment|"Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Forced Vital Capacity (FVC) was measured at day 28 of treatment. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.~FVC at day 28 of treatment was measured via spirometry (see Outcome Measure #24). All FVC responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FVC data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1417519|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Peak Forced Expiratory Volume in One Second at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Peak FEV1 is the maximum FEV1 recorded in a pre-determined period of time.~Percentage of the maximal response of NVA237 within different doses/regimens of NVA237 on Peak FEV1 was measured at day 28 of treatment.~Peak FEV1 was measured in response to all doses administered (see Outcome Measure #23). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1417520|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second at 12 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Percentage of the maximal response within different doses/regimens of NVA237 was measured using FEV1 at 12 hours on day 28 of treatment.~FEV1 was measured in response to all doses administered (see Outcome Measure #22). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|12 hours on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response||90% Confidence Interval|Mean
1417521|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve at Different Time Points (0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours) on Day 28|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-4 Hours, 0-8 Hours, 0-12 Hours, 12-24 Hours were calculated from measurements taken at: 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #21). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response* hours||90% Confidence Interval|Mean
1417549|NCT01119846|Secondary|Part B: Summary of Plasma Cmax|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours on Day 1 of each treatment period.|PK Population.|||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
1424572|NCT01059760|Primary|Change From Baseline in Participant Platelet Count When Fasting and Fed||Baseline and 3 days||||cells x 10^3/mL||Standard Deviation|Mean
1417522|NCT01119950|Secondary|Forced Expiratory Volume in One Second AUC 0-24 Hours for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237, After 28 Days of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~The Area Under the Curve (AUC) 0-24 hours FEV1 between dosing regimens over the range 20 micrograms to 55 micrograms total daily dose at -25 min,-15 min (predose); 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC 0-24 hours FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 20), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens."|-25 min,-15 min (predose); 5 min,15 min, 1,2,3,4,6,8,10 hours, 11 hours 55min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||90% Confidence Interval|Mean
1417523|NCT01119950|Secondary|Percentage of the Maximal Response of NVA237 Doses on Forced Expiratory Volume in One Second Area Under the Curve 0-24 Hours at Day 28 of Treatment|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~Percentage of the maximal response of NVA237 doses on FEV1 Area Under the Curve (AUC) 0-24 hours at day 28 of treatment was calculated from measurements taken at 5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28.~AUC FEV1 was measured in response to all doses administered (see Outcome Measure #20). All FEV1 responses to active doses were corrected using the placebo response. A modeled dose response curve was fit to the placebo-corrected data, and extrapolated to estimate the maximal response. All FEV1 data are reported as a percentage of the theoretical maximal response."|5 min, 15 min, 1,2,3,4,6,8,10 hours, 11 hours 55 min, 14,20,22 hours; 23 hours 15 min, 23 hours 45 min (postdose) on day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Percentage of maximal response * hours||90% Confidence Interval|Mean
1417524|NCT01119950|Secondary|Trough Forced Expiratory Volume in One Second for Once and Twice Daily Regimens of NVA237 for the Same Total Daily Dose of NVA237|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.~FEV1 was measured between dosing regimens (over the range 20 micrograms to 55 micrograms total daily dose) after 28 days of treatment.~Mean trough FEV1 was measured in response to all doses administered (12.5 µg q.d., 25.0 µg q.d., 12.5 µg b.i.d., 50 µg q.d., 25 µg b.i.d., 100 µg q.d., 50.0 µg b.i.d., and Placebo; see Outcome Measure # 19), and was used to compute modeled dose-response curves for once-daily and twice-daily regimens separately. The difference between those curves was computed at pre-specified theoretical doses (20 µg, 25 µg, 30 µg, 35 µg, 40 µg, 45 µg, 50 µg, and 55 µg) chosen at points likely to show the largest differences between the once-daily and twice-daily regimens. The theoretical responses to each dosing schedule separately and the difference between the once-daily and twice-daily regimens are represented below."|day 28|Full analysis set includes all randomized patients who received at least one dose of study drug and data available for analysis. Only patients with non-missing values were included.|||Liters||90% Confidence Interval|Mean
1417525|NCT01119937|Secondary|Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period|Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
1417526|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period|Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
1417527|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period|Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
1417528|NCT01119937|Secondary|Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period|Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL|52 weeks|Safety population - all patients who received at least one dose of study drug. Only participants with the required measurements were included for each specific value.|||participants|||Number
1417529|NCT01119937|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over the Whole Treatment Period|Patients recorded rescue medication use in a paper patient diary. If a patient required the use of salbutamol as rescue medication due to an increase in COPD symptoms, the number of inhalations (puffs) taken was recorded in the patient diary.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug|||change in puffs||Standard Deviation|Mean
1417594|NCT01119768|Secondary|Symptom Relief Rate in 2 Treatment Regimens.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|8 weeks for arm 1, 2 weeks for arm 2|ITT was defined as all randomized subjects who took at least one dose of treatment.|||percentage of participans|||Number
1417531|NCT01119937|Secondary|Number of Patients With Moderate or Severe COPD Exacerbations|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug|||participants|||Number
1417532|NCT01119937|Secondary|Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation|Moderate COPD exacerbations were defined as: worsening of 2 or more of the following major symptoms for at least 2 consecutive days - dyspnea, sputum volume and sputum purulence; OR a worsening of any 1 major symptom with any 1 of the following minor symptoms for at least 2 consecutive days - sore throat, colds, fever without other cause, increased cough or increased wheeze, requiring treatment with systemic glucocorticosteroids or antibiotics or both. Severe COPD exacerbations were defined as: conditions for Moderate COPD exacerbation and hospitalization was required. Participants who withdraw from the study and do not experience a moderate or severe exacerbation are censored at the date of withdrawal. Participants who complete the study and do not experience a moderate or severe exacerbation are censored at the completion visit date.|52 weeks|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug|||days|||Number
1417533|NCT01119937|Secondary|Change in Pre-dose FVC From Baseline|Pre-dose FVC is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.|||liters||Standard Deviation|Mean
1417534|NCT01119937|Secondary|Change in Pre-dose FEV1 From Baseline|Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 minutes pre-dose.|Weeks 12, 24, 36 and 52|Intent-to-treat (ITT) population - included all randomized patients who received at least one dose of study drug. Only participants with measurements at both baseline and the specified timepoint were included in the analysis for the specific timepoint.|||liters||Standard Deviation|Mean
1417535|NCT01119937|Primary|Number of Participants With Adverse Events, Serious Adverse Events or Death|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug|||participants|||Number
1417536|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
1417537|NCT01119859|Secondary|Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
1417538|NCT01119859|Secondary|Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24|Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
1417539|NCT01119859|Secondary|Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24|The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
1417540|NCT01119859|Secondary|Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24|The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported.|Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Percentage of patients|||Number
1417541|NCT01119859|Primary|Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US).|Baseline to Week 24|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.|||Units on a scale||95% Confidence Interval|Mean
1417542|NCT01119846|Secondary|Part C: Summary of AUC0-24, AUC0-t of GSK1292263 and Sitagliptin When Co-administered|The AUC0-10, AUC0-12 and AUC0-24 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post- breakfast), 1, 2, 4 (= pre lunch), 6, 10 (= immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Nanograms×hour per mL||Geometric Coefficient of Variation|Geometric Mean
1417543|NCT01119846|Secondary|Part C: Summary of T-half and Tmax of GSK1292263 and Sitagliptin When Co-administered|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (= immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
1417544|NCT01119846|Secondary|Part C: Summary of Cmax of GSK1292263 and Sitagliptin When Co-administered|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (= immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
1417545|NCT01119846|Secondary|Part B: Summary of Change From Baseline in Fasted Glucagon, GLP-1, C-peptide, Total GIP, Total PYY and Insulin|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period. For breakfast, lunch and evening meal in Part B, samples were collected just after the meal and at the following times after starting each meal: 0.5, 1 and 2 hours. Samples were also collected in Part B at 24 hours post-dose. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value from post-Baseline value.|Baseline (Day 1 pre-dose) and Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Pico moles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417546|NCT01119846|Secondary|Part B: Summary of Change From Baseline in Fasted Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value from post-Baseline value.|Baseline (Day 1 pre-dose) and Day 1 (24 hours)|The PD Population included participants from the Safety Population who had any PD parameter estimates from any portion of the study.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417547|NCT01119846|Secondary|Part B: Summary of AUC0-t and AUC0-24|The AUC 0-24 and AUC 0-t determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours on Day 1 of each treatment period|PK Population.|||Nanograms×hour per mL||Geometric Coefficient of Variation|Geometric Mean
1417548|NCT01119846|Secondary|Part B: Summary of T-max and T-lag|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 13 and 24 hours on Day 1 of each treatment period|PK Population.|||Hour||Full Range|Median
1417550|NCT01119846|Secondary|Part B: Number of Participants With Abnormal Vital Signs of PCI|SBP, DBP and pulse rate measurements were recorded at each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 min. Participants with abnormal clinically significant vital signs findings is presented. It was assessed on Screening, Day -1, 1, 2 (pre-dose, 1, 3, 4, 6, 10, 16 and 24 hours of each treatment period) and Follow-up (7 -10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417551|NCT01119846|Secondary|Part B: Number of Participants With Significant ECG Abnormalities|Twelve-lead ECGs was obtained in a supine position at each time point during the study using an ECG machine that automatically measured PR, QRS, QT and QTc intervals (QTcB and QTcF). Participants with abnormal clinically significant ECG findings is presented. It was assessed on Screening, Day 1 at pre-dose, 1, 2, 3, 4, 6, 10, 16, 24 hours and Follow-up (7 -10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417552|NCT01119846|Secondary|Part B: Number of Participants With Abnormal Clinical Chemistry Parameters of PCI|Clinical chemistry parameters included BUN, potassium, AST, total and direct bilirubin, creatinine, chloride, ALT, uric acid, glucose fasting, GGT, albumin, sodium, magnesium, phosphorus inorganic, calcium, total CO2, ALP, triglycerides, total cholesterol, LDL cholesterol, free fatty acid (NEFA), HDL cholesterol and total protein. It was assessed on Screening, Day -1, 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters (Glucose, High) for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417553|NCT01119846|Secondary|Part B: Number of Participants With Abnormal Hematology Parameters of PCI|Hematology parameters included platelet count, RBC count, MCV, total neutrophils, WBC absolute, MCH, lymphocytes, MCHC, monocytes, hemoglobin, eosinophils, hematocrit, reticulocytes and basophils. It was assessed on Screening, Day -1, 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417554|NCT01119846|Secondary|Part B: Number of Participants With AEs and SAEs|An AE was defined as any untoward MO in a participant temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417555|NCT01119846|Primary|Part C: Summary of Change From Baseline in Fasted Insulin|Blood samples were collected fasting pre-breakfast and pre-morning dose (PD time 0) on Days -1, 13 and 14 and then at 10, 20, 30, 60, 90, 120, 180 min after eating the standardized breakfast meal tolerance test. For lunch (4 hour post-morning dose) samples were collected just before the meal and after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (10 hour post-morning dose), BID dosing groups followed the sequence of sampling, food and dosing as for breakfast (PD sample immediately before meal, eat and then dose), then 0.5, 1, 1.5, 2 and 3 hours post-dinner. A sample was also collected 24 hours post-dose. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value minus post-Baseline value. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Baseline (Day 1 pre-dose) and Day -1, 13 and 14|The PD Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417556|NCT01119846|Primary|Part C: Summary of Change From Baseline in Fasted Glucose|Blood samples were collected fasting pre-breakfast and pre-morning dose (PD time 0) on Days -1, 13 and 14 and then at 10, 20, 30, 60, 90, 120, 180 min after eating the standardized breakfast meal tolerance test. For lunch (4 hour post-morning dose) samples were collected just before the meal and after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (10 hour post-morning dose), BID dosing groups followed the sequence of sampling, food and dosing as for breakfast (PD sample immediately before meal, eat and then dose), then 0.5, 1, 1.5, 2 and 3 hours post-dinner. A sample was also collected 24 hours post-dose. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value minus post-Baseline value. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Baseline (Day 1 pre-dose) and Day -1, 13 and 14.|PD Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417557|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Insulin Sensitivity Index|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated as 10,000/square root ([mean plasma insulin × mean plasma glucose during OGTT or meal challenge] × [fasting plasma glucose × fasting plasma insulin]). The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||1/(mg/dL)×1/(µIU/mL)||Geometric Coefficient of Variation|Geometric Mean
1417558|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Insulin Glucose Index|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated as insulin (30 min) – insulin (0 min)/glucose (30 min) – glucose (0 min). It was calculated as insulin (30 min) – insulin (0 min)/glucose (30 min) – glucose (0 min). The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||µIU/mL/mg/dL||Geometric Coefficient of Variation|Geometric Mean
1417559|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Glucose/Insulin and Insulin/Glucose Ratio|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated as insulin/glucose ratio was calculated as insulin AUC(0-3]/glucose AUC(0-3) during OGTT, while glucose/insulin ratio was calculated as glucose AUC(0-3)/insulin AUC(0-3) during OGTT. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1417560|NCT01119846|Primary|Part A: Summary of the OGTT Derived Parameters: Disposition Index|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. It was calculated by multiplying insulin glucose index with insulin sensitivity index. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||[(µIU/mL)/(mg/deciliter [dL])]^2||Geometric Coefficient of Variation|Geometric Mean
1417561|NCT01119846|Primary|Part A: Summary of the OGTT AUC (0-2) and iAUC(0-2)- C-peptide, Total GIP, GLP-1 (Active and Total), Glucagon and Total PYY and AUC 0-3 and iAUC 0-3 of Insulin|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Pico moles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417562|NCT01119846|Primary|Part A: Summary of the OGTT AUC (0-3) and iAUC(0-3)-Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417563|NCT01119846|Primary|Part A: Summary of the AUC 0-12 and iAUC 0-12 of Glucagon, Glucagon-like Peptide (GLP; Active and Total)-1, C-peptide, Total Glucose-dependent Insulinotropic Peptide (GIP) and Total Peptide Tyrosine-tyrosine (PYY) and AUC 0-13 and iAUC 0-13 of Insulin|Blood samples for the determination of glucose and other PD markers were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population.|||Pico moles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417564|NCT01119846|Primary|Part A: Summary of the AUC 0-13, AUC 0-24, Incremental AUC (iAUC) 0-13 and iAUC 0-24 of Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Up to Day 1 (24 hours)|PD Population.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417565|NCT01119846|Primary|Part A: Summary of Change From Baseline in Fasted Glucose|Blood samples for the determination of glucose were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. Change from Baseline was calculated by subtracting Baseline value from post-Baseline value. The point estimates and corresponding 95% CI for treatment ratios were calculated for treatment comparisons versus placebo.|Baseline (Day 1 pre-dose) and Day 1 (24 hours)|The PD Population included participants from the Safety Population who had any PD parameter estimates from any portion of the study.|||Millimoles per Liter||Geometric Coefficient of Variation|Geometric Mean
1417566|NCT01119846|Primary|Part C: Relationships Between GSK1292263 Drug Exposures and Insulin Sensitivity|"Blood samples for the determination of insulin were collected fasting pre-breakfast and then pre-morning dose (PD time 0) on Days -1, 13 and 14, and then at 10, 20, 30, 60, 90, 120, 180 min after eating the standardized breakfast meal tolerance test. For lunch (approximately 4 hour post-morning dose) samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5, 2 and 3 hours. For the evening meal (approximately 10 hour post-morning dose), BID dosing groups followed the sequence of sampling, food and dosing as for breakfast (PD sample immediately before meal, eat and then dose), then 0.5, 1, 1.5, 2 and 3 hours post-dinner. A sample was also collected 24 hours post-dose.~When this results in multiple samples at the same time point, only one sample was collected (example: 24 hours post first-dose = pre-dose [time 0] for the second dose)."|Day -1, 13 and 14|PK/PD Population.|||mL/min×1/µIU×10^4||Geometric Coefficient of Variation|Geometric Mean
1417713|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng・h/mL||Standard Deviation|Mean
1417567|NCT01119846|Primary|Part A: Relationships Between GSK1292263 Drug Exposures and Insulin Sensitivity|Blood samples for the determination of insulin were collected at pre-dose on Day 1 of each dosing period and immediately prior to and at 10, 20, 30, 60, 90, 120, 180 min after administration of the 75 grams glucose drink. For lunch and evening meal in Part A, samples were collected just before the meal and at the following times after starting each meal: 0.5, 1, 1.5 (except breakfast in Part B), 2 and 3 hours. When this results in multiple samples at the same time point, only one sample was collected. The unit of measure is mL/min×1/micro international unit×10^4 (mL/min×1/µIU×10^4).|Day 1 of each treatment period|The PK/PD Population included all participants who were in both the PK and PD populations, as well as those in the PD population who received the placebo treatment.|||mL/min×1/µIU×10^4||Geometric Coefficient of Variation|Geometric Mean
1417568|NCT01119846|Primary|Part C: Summary of Time Invariance Ratio (Rs) of Cmax|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post-breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected. Cmax for one participant from 50 BID x 14 day was not analyzed due to positive definite G Matrix.|Days 1, 7, 13 and 14|PK Population.|||Ratio||90% Confidence Interval|Geometric Least Squares Mean
1417569|NCT01119846|Primary|Part C: Summary of Time Invariance Ratio (Rs) of AUC0-24 for Once Daily Dose of GSK1292263|The AUC0-24 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post-breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||90% Confidence Interval|Geometric Mean
1417570|NCT01119846|Primary|Part C: Summary of Time Invariance Ratio (Rs) of AUC0-10 for BID Dose of GSK1292263|The AUC0-10 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post-breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||90% Confidence Interval|Geometric Mean
1417571|NCT01119846|Primary|Part C: Summary of Accumulation Ratio (Ro)|Ro was derived as follows: Ro = Day 13 (AUC0-24)/Day 1 (AUC0-24) for once daily dosing; Ro = Day 13 AM (AUC0-10)/Day 1 AM (AUC0-10) for BID dosing and Ro = Day 13 (AUC0-24)/Day 1 (AUC0-24) for BID dosing. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected. Data presented for Day 13 and Day 14.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1417572|NCT01119846|Primary|Part C: Summary of AUC0-10, AUC0-12 and AUC0-24|The AUC0-10, AUC0-12 and AUC0-24 determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For QD and BID dosing regimens on Day 7, blood samples were collected at pre-dose (=post- breakfast), 1, 2, 4 (=pre lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|PK Population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1417573|NCT01119846|Primary|Part C: Summary of T-max and T-lag|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
1417714|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
1417574|NCT01119846|Primary|Part C: Summary of Plasma Cmax|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. When GSK1292263 was dosed once daily, blood samples were collected on Days 1, 13 and 14 immediately pre-dose (time 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-dose. When GSK1292263 was dosed BID, blood samples were collected on Days 1, 13 and 14, at immediately pre-morning dose, 1,2, 4, 6, 8, 10, 11, 12, 14, 16, 18 and 24 hours post-morning dose. For once daily and BID dosing regimens on Day 7, blood samples were collected at pre-dose (= post-breakfast), 1, 2, 4 (= pre-lunch), 6, 10 (=immediately post-dinner) and 12 hours. When planned PK sampling results in multiple samples at the same time point, only one sample was collected.|Days 1, 7, 13 and 14|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.|||Nanograms per millimeter||Geometric Coefficient of Variation|Geometric Least Squares Mean
1417575|NCT01119846|Primary|Part C: Number of Participants With Abnormal Vital Signs of PCI|SBP, DBP and pulse rate measurements were recorded at each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Participants with abnormal clinically significant vital signs findings is presented. It was assessed on Screening, on Days -1 to 14 in a fasting state early in the morning (prior to morning dosing on days 1-14) and at Follow-up. On Days 1, 7, 13 and 14, it was also taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose each treatment period and Follow-up (7 to 10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417576|NCT01119846|Primary|Part C: Number of Participants With Significant ECG Abnormalities|Twelve-lead ECGs was obtained in a supine position at each time point during the study using an ECG machine that automatically measured PR, QRS, QT and QTc intervals (QTcB and QTcF). Participants with abnormal clinically significant ECG findings is presented. It was assessed on Screening, on Day -1, 1, 7, 13 and 14 pre-breakfast dose (fasting) and at 1, 3, 6, 9, 12 and 24 hours of each treatment period and Follow-up (7 to 10 days after final discharge).|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417577|NCT01119846|Primary|Part C: Number of Participants With Abnormal Clinical Chemistry Parameters of PCI|Clinical chemistry parameters included BUN, potassium, AST, total and direct bilirubin, creatinine, chloride, ALT, uric acid, glucose fasting, GGT, albumin, sodium, magnesium, phosphorus inorganic, calcium, total CO2, ALP, triglycerides, total cholesterol, LDL cholesterol, free fatty acid (NEFA), HDL cholesterol and total protein. It was assessed on Screening, Day -2 (can be non-fasting) and prior to breakfast (early in the morning, fasting) on Days 1, 7 and 14, and on Day 15 prior to checkout, (=24 hours post-dose) of each treatment period and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417578|NCT01119846|Primary|Part C: Number of Participants With Abnormal Hematology Parameters of PCI|Hematology parameters included platelet count, RBC count, MCV, total neutrophils, WBC absolute, MCH, lymphocytes, MCHC, monocytes, hemoglobin, eosinophils, hematocrit, reticulocytes and basophils. It was assessed on Screening, Day -2 (can be non-fasting) and prior to breakfast (early in the morning, fasting) on Days 1, 7 and 14, and on Day 15 prior to checkout, (=24 hours post-dose) of each treatment period and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417579|NCT01119846|Primary|Part C: Number of Participants With AEs and SAEs|An AE was defined as any untoward MO in a participant temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 7|Safety Population.|||Participants|||Count of Participants
1417580|NCT01119846|Primary|Part A: Summary of Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) and Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)|The AUC 0-24 and AUC 0-t determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for the determination of PK was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours on Day 1 of each treatment period|Pharmacokinetic Population.|||Nanograms×hour per milliliters||Geometric Coefficient of Variation|Geometric Mean
1417581|NCT01119846|Primary|Part A: Summary of Time to Maximum Concentration (T-max) and Lag Time Before Observation of Drug Concentration in Sampled Matrix (T-lag)|The time at which Cmax was observed was determined directly from the raw concentration-time data. The lag time before observation of drug concentrations in sample matrix determined as the time of the sample preceding the first quantifiable concentration. Blood samples for the determination of PK was collected on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours on Day 1 of each treatment period|Pharmacokinetic Population.|||Hour||Full Range|Median
1417582|NCT01119846|Primary|Part A: Summary of Maximum Plasma Concentration (Cmax)|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Blood samples for the determination of PKs was collected at on Day 1 of each period: immediately pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours.|Pre-dose (time 0) and at 0.5, 1, 2, 3, 4, 6, 8, 14 and 24 hours on Day 1 of each treatment period|The Pharmacokinetic Population included all participants from the Safety Population who have any pharmacokinetic parameter estimates from any portion of the study.|||Nanograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
1417692|NCT01118988|Secondary|Health Belief Scale (HBS) Short Version - Child Report|Number of treatment modalities rated 1-4 by participants on the HBS questionnaire, which asked participants to rate how much they think each of 16 listed treatment modalities would help with pain (1=Completely, 2=A lot, 3=Some, 4=A little, 5=Not at all).|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||Number of treatments||Standard Deviation|Mean
1417583|NCT01119846|Primary|Part A: Number of Participants With Abnormal Vital Signs of PCI|Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate measurements were recorded at each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Participants with abnormal clinically significant vital signs findings is presented. It was assessed on Screening, Day -1, 1, 2 (pre-dose, 1, 3, 4, 6, 10, 16 and 24 hours of each treatment period) and Follow-up (7 to10 days after final discharge).|Up to Week 10.|Safety Population.|||Participants|||Count of Participants
1417584|NCT01119846|Primary|Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve-lead ECGs was obtained in a supine position at each time point during the study using an ECG machine that automatically measured PR, QRS, QT and QTc intervals (QT duration corrected for heart rate by Bazett’s formula [QTcB] and Fridericia’s formula [QTcF]). Participants with abnormal clinically significant ECG findings is presented. It was assessed on Screening, Day 1 at pre-dose, 1, 2, 3, 4, 6, 10, 16, 24 hours and Follow-up (7 to 10 days after final discharge).|Up to Week 10|Safety Population.|||Participants|||Count of Participants
1417585|NCT01119846|Primary|Part A: Number of Participants With Abnormal Clinical Chemistry Parameters of PCI|Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total and direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, glucose fasting, gamma glutamyltransferase (GGT), albumin, sodium, magnesium, phosphorus inorganic, calcium, total carbon dioxide (CO2), alkaline phosphatase (ALP), triglycerides, total cholesterol, low-density lipoprotein (LDL) cholesterol, free fatty acid (non-esterified fatty acids; [NEFA]), high-density lipoprotein (HDL) cholesterol and total protein. It was assessed on Screening, Day -1, Day 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 10|Safety Population.|||Participants|||Count of Participants
1417586|NCT01119846|Primary|Part A: Number of Participants With Abnormal Hematology Parameters of Potential Clinical Importance (PCI)|Hematology parameters included platelet count, red blood cell (RBC) count, mean corpuscular volume (MCV), total neutrophils, white blood cell count (WBC; absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit, reticulocytes and basophils. It was assessed on Screening, Day -1, Day 2 (of each treatment period) and Follow-up (7 to 10 days after final discharge). Only those parameters (hemoglobin, high) for which at least one value of PCI was reported are summarized. Null data is not presented.|Up to Week 10|Safety Population.|||Participants|||Count of Participants
1417587|NCT01119846|Primary|Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Week 10|Safety Population comprised of all participants enrolled in the study and who had received at least one dose of study drug.|||Participants|||Count of Participants
1417588|NCT01119794|Primary|Overall Response Rate (ORR) of the Combination of Ofatumumab and Bortezomib in Patients Receiving Study Treatment|"Response was assessed based on Bone marrow biopsy and CT scan. Best responses are used for Response Rate and CR and PR only.~Complete Response – CR:~• Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~Partial Response - PR:~• At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses.~Stable Disease – SD:~• A patient is considered to have SD when he or she fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease~Relapsed Disease:~• Lymph nodes should be considered abnormal if the long axis is more than 1.5 cm regardless of the short axis."|Bone Marrow Biopsy: Every 2 months for 1 year then every 4 months until progression for approximately 1 year/Via CT scan: every 4 months until progression, for a total of approximately 2 years|8/10 patients were evaluable as 2 withdrew|||participants|||Number
1417589|NCT01119768|Secondary|Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|16 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.|||percentage of participants|||Number
1417590|NCT01119768|Secondary|Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|8 weeks|Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment|||percentage of participants|||Number
1417591|NCT01119768|Secondary|Percentage of Patients Satisfaction|Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.|24 weeks after end of treatment|MITT|||percentage of participants|||Number
1417592|NCT01119768|Secondary|Number of Patients With Unscheduled Hospital Visit(s)||from baseline to week 24 after end of treatment|MITT|||participants|||Number
1417593|NCT01119768|Secondary|Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.|Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.|2 and 8 weeks|ITT in 8 weeks treatment group|||percentage of participants|||Number
1417595|NCT01119768|Secondary|Time to First Relapse.|"Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.~Time to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint"|From baseline to 24 weeks after end of treatment|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.|||days||Inter-Quartile Range|Median
1417596|NCT01119768|Secondary|The Success Rate in Whole Study Duration.|Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.|24 weeks after end of treatment|Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment.|||percentage of participants|||Number
1417597|NCT01119768|Primary|Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.|GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.|24 weeks|MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment|||percentage of participants|||Number
1417598|NCT01119755|Secondary|Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
1417599|NCT01119755|Secondary|Mean Difference of Systolic Home Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
1417600|NCT01119755|Secondary|Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
1417601|NCT01119755|Primary|Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
1417602|NCT01119755|Primary|Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter|Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period|1 year||||mmHg||Standard Deviation|Mean
1417603|NCT01119755|Primary|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter|Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period|1 year||||mmHg||Standard Deviation|Mean
1417604|NCT01119755|Secondary|Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter||1 year||||mmHg||Standard Deviation|Mean
1417605|NCT01119755|Primary|Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.|Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period|1 year||||mmHg||Standard Deviation|Mean
1417606|NCT01119716|Primary|Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation||up to 60 days from day of treatment (cardioversion)|All enrolled participants with follow-up data available|||Participants|||Number
1417607|NCT01119716|Primary|Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion|Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.|At time of treatment (up to 1 day from admission)|Participants who had artrial fibrillation treated by either electrical or pharmacological cardioversion.|||Percentage of Participants|||Number
1417608|NCT01119716|Primary|Treatments Utilized for Participants for Atrial Fibrillation||At time of Treatment (up to 1 day from admission)|All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation.|||Participants|||Number
1417609|NCT01119716|Primary|Clinical Type of Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with admission (baseline) atrial fibrillation data available.|||Percentage of Participants|||Number
1417610|NCT01119716|Primary|Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with co-morbity data available.|||Percentage of Participants|||Number
1417611|NCT01119716|Primary|Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)||Baseline (time of admission)|All enrolled participants with baseline cardiovascular history data.|||Percentage of Participants|||Number
1417612|NCT01119703|Secondary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417629|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1417613|NCT01119703|Secondary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417614|NCT01119703|Secondary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log(ln)."|Day 7 and 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417615|NCT01119703|Secondary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Early Post-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected at 7 days post-baseline vaccination to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Day 7 and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417616|NCT01119703|Primary|Post-vaccination Antibody Titer Responses to Different Vaccines in Healthy, Elderly, Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to each of these four antigens were then measured 1 month after each final vaccination (3 weeks for cholera toxin), based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln)."|3 weeks or 1 month after each final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417617|NCT01119703|Primary|Antibody Titer Responses to Oral Cholera Vaccine (WC/rBS), Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to cholera were then measured 3 weeks after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 3 weeks after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417618|NCT01119703|Primary|Antibody Titer Responses to Reduced Diphtheria Toxin Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to diphtheria were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417654|NCT01119443|Secondary|Cτ,ss (Fed Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Error|Geometric Mean
1417619|NCT01119703|Primary|Antibody Titer Responses to Tetanus Booster Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to tetanus were then measured 1 month after final vaccination, based on ELISA, and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by mRNA profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417620|NCT01119703|Primary|Antibody Titer Responses to Hepatitis B Virus Surface Antigen (HBV sAg) Vaccine, Measured and Predicted Based on Pre-vaccination Biomarkers in Healthy, Elderly Participants.|"Healthy elderly participants were simultaneously vaccinated at baseline with hepatitis vaccine, tetanus-diphtheria booster vaccine, and cholera vaccine. Antibody titers to HBV sAg were then measured 1 month after final vaccination, based on enzyme linked immunosorbent assay (ELISA), and are defined as standardized international units of reactivity converted from optical densities, transformed to natural log (ln). In order to predict antibody responses blood samples were collected prior to vaccination at baseline, to measure a wide variety of biomarkers by messenger RNA (mRNA) profiling, biochemical and flow cytometric assays. These biomarkers were then used in a machine-learning (random-forest based) model to predict antibody titers, transformed to natural log (ln)."|Baseline and 1 month after final vaccination|Healthy participants 65 years of age and older who were treated with all three vaccines, and had their post-vaccination titers measured. Results from comparing titers and biomarker responses between younger and older cohorts are exploratory, and therefore not reported.|||ln International Units||Standard Deviation|Mean
1417621|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1417622|NCT01119625|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).|Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1417623|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
1417624|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1417625|NCT01119625|Secondary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
1417626|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1417627|NCT01119625|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before and one month after booster vaccination (at Month 0 and Month 1)|The ATP cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1417628|NCT01119625|Secondary|Titers of Antibodies Against Poliovirus Types 1, 2 and 3.|Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||Titers||95% Confidence Interval|Geometric Mean
1417630|NCT01119625|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||EU/mL||95% Confidence Interval|Geometric Mean
1417631|NCT01119625|Secondary|Concentrations of Antibodies Against Diphtheria and Tetanus.|Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||IU/mL||95% Confidence Interval|Geometric Mean
1417632|NCT01119625|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.|"Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1417633|NCT01119625|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||2099-12-31|12/2099||||
1417634|NCT01119625|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.|Opsonophagocytic activity (OPA) testing was not performed.|Before and one month after booster vaccination (at Month 0 and Month 1)||2099-12-31|12/2099||||
1417635|NCT01119625|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.|||Subjects|||Number
1417636|NCT01119625|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 31 days (Days 0-30) after booster vaccination|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented.|||Subjects|||Number
1417637|NCT01119625|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).|"Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).~Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.~Related = solicited symptom assessed by the investigator as causally related to study vaccination."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.|||Subjects|||Number
1417638|NCT01119625|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).|"Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period.~Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)."|Within 4 days (Days 0-3) after booster vaccination.|The analysis of safety was performed on the Total vaccinated cohort which included all subjects with booster dose administration documented. The analysis of the solicited symptoms based on the Total Vaccinated cohort included subjects with documented safety data.|||Subjects|||Number
1417639|NCT01119625|Primary|Concentrations of Antibodies Against Protein D (PD).|Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||EU/mL||95% Confidence Interval|Geometric Mean
1417655|NCT01119443|Primary|Cmax,ss (Fed Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
1424573|NCT01059760|Primary|Change From Baseline in Participant Hematocrit When Fasting and Fed||Baseline and 3 days||||% of red blood cells to whole blood||Standard Deviation|Mean
1417640|NCT01119625|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|"Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).~Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL."|Before booster vaccination at Month 0|The analysis was performed on the According-To-Protocol cohort for analysis of antibody persistence which included subjects primed in the primary study (NCT00808444) and for whom assay results were available for antibodies against at least 1 vaccine antigen component for the blood sampling taken before the administration of the booster dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1417641|NCT01119443|Secondary|MRTpo,ss (Fasted Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
1417642|NCT01119443|Secondary|t1/2,ss (Fasted Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
1417643|NCT01119443|Secondary|λz,ss (Fasted Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||/hour||Standard Deviation|Geometric Mean
1417644|NCT01119443|Secondary|Tmax,ss (Fasted Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Full Range|Mean
1417645|NCT01119443|Secondary|Cmin,ss (Fasted Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
1417646|NCT01119443|Secondary|Cτ,ss (Fasted Conditions)|Concentration of the analyte in plasma at time τ at steady state|pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Error|Geometric Mean
1417647|NCT01119443|Primary|Cmax,ss (Fasted Conditions)|maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
1417648|NCT01119443|Primary|AUCτ,ss (Fasted Conditions)|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
1417649|NCT01119443|Secondary|MRTpo,ss (Fed Conditions)|Mean residence time of the analyte in the body at steady state after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
1417650|NCT01119443|Secondary|t1/2,ss (Fed Conditions)|Terminal half-life of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Standard Deviation|Geometric Mean
1417651|NCT01119443|Secondary|λz,ss (Fed Conditions)|Terminal rate constant of the analyte in plasma at steady state|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||per hour||Standard Deviation|Geometric Mean
1417652|NCT01119443|Secondary|Tmax,ss (Fed Conditions)|Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||hour||Full Range|Mean
1417653|NCT01119443|Secondary|Cmin,ss (Fed Conditions)|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ|Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration|One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set|||ng/mL||Standard Deviation|Geometric Mean
1417715|NCT01118845|Secondary|The Maximum Concentration (Cmax) of Unchanged SyB L-0501 in Japan||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng/mL||Standard Deviation|Mean
1417657|NCT01119287|Primary|Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo|Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison.|Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)|Number of subjects with data available in the specific treatment group|||hours x units on a scale||Standard Deviation|Mean
1417658|NCT01119287|Primary|Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo|Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison.|Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)|Number of subjects with data available in the specific treatment group|||hours x units on a scale||Standard Deviation|Mean
1417659|NCT01119248|Secondary|Relationship Between Body Surface Area (BSA) and Change in Body Temperature After MRI|Bivariate analysis between BSA and change in body temperature after MRI. Reported is the change in body temperature after MRI with 1m2 increase in BSA, after adjusting type of MRI and duration of MRI. A positive change value reflects increase in body temperature with an increase in BSA and vice versa|Prior to start of general anesthesia and immediately after completion of MRI scan an average of two hours|120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient|||celsius degrees||95% Confidence Interval|Number
1417660|NCT01119248|Secondary|Relationship Between Pre MRI Body Temperature and Change in Body Temperature After MRI|Bivariate analysis between pre MRI body temperature and change in body temperature after MRI. Body temperature of the subjects was measured with MRI compatible Tempadot. Reported is the change in body temperature after MRI with 1 degree increase in body temperature between subjects after adjusting for body surface area (BSA), type of MRI and duration of MRI. A positive change value reflects a child who was 1 degree C warmer experienced greater warming. The negative change reflects that a child who was 1 degree C warmer experienced greater cooling.|Prior to start of general anesthesia and immediately after completion of MRI an average of two hours|120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient|||celsius degrees||95% Confidence Interval|Mean
1417661|NCT01119248|Primary|Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI|Axillary temperature was measured with MRI-compatible Tempa dot immediately before general anesthesia was induced. Second axillary temperature reading was taken at the conclusion of the MRI scan before emergence from general anesthesia. Room temperature was measured with a digital thermometer placed in scanner room outside the magnet range.|prior to induction of general anesthesia and at conclusion of MRI an average of two hours|120 children were enrolled for the prospective cohort study. 5 children were excluded from the study: 3 did not fit study criteria after enrollment before start of the procedure, one did not get any intravenous fluids during scan, the MRI scan was cancelled after enrollment in one patient|||celsius degrees||Full Range|Mean
1417662|NCT01119222|Secondary|Number of Participants With Abnormal Pulse Oxymetry Results|Pulse oxymetry to monitor percentage of hemoglobin saturated with oxygen during intervenous (IV) infusion dosing (morphine or placebo).|Predose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although pulse oxymetry was performed throughout IV dosing, results were not captured for inclusion in the study database.|||participants|||Number
1417663|NCT01119222|Secondary|Number of Participants With Abnormal Cardiac Monitoring Results|Continuous cardiac monitoring during intervenous (IV) infusion dosing (morphine or placebo).|Pre-dose through duration of IV infusion dosing|Safety population: all subjects who received at least 1 dose of study medication. Although continuous cardiac monitoring was performed throughout IV dosing, results were not captured for inclusion in the study database.|||participants|||Number
1417664|NCT01119222|Secondary|Number of Participants With Abnormal Haematology, Clinical Chemistry, Urinalysis Results|Standard haematology, clinical chemistry, and urinalysis safety laboratory tests.|Pre-dose, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.|||particpants|||Number
1417665|NCT01119222|Secondary|Number of Participants With Abnormal Findings on Electrocardiogram (ECG)|Standard 12-lead ECG performed after subject had rested quietly for at least 10 minutes in a supine position.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected and monitored, summary statistics were not generated for this outcome measure.|||participants|||Number
1417666|NCT01119222|Secondary|Number of Participants With Clinically Significant Abnormal Findings on Physical Examination|Full physical examination consisting of an examination of the abdomen, cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland.|Pre-dose and follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual subject data were collected, results were not captured for inclusion in the study database.|||participants|||Number
1417693|NCT01118988|Secondary|Child Anxiety Sensitivity Inventory (CASI) - Child Report|"Assessment of child's anxiety sensitivity~18 items, range 18-54, higher scores = more anxiety sensitivity"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417667|NCT01119222|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Supine blood pressure measured to nearest millimeter of mercury (mmHg), pulse rate measured with automated device or manually in the brachial/radial artery for at least 30 seconds.|Predose, Day 1, Day 2 each treatment period, follow-up visit (at least 7 days after last dosing)|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.|||participants|||Number
1417668|NCT01119222|Primary|Interpolated Average Pain (0-8 Hours)|Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8.|Pre-dose to 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.|||hours||Standard Error|Least Squares Mean
1417669|NCT01119222|Primary|Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)|"Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of no pain (0) to maximum pain (100) at the anchor endpoints of the scale and moderate pain at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec."|Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose|Participants for analysis = participants who completed all of the four treatment periods.|||mm||Standard Deviation|Mean
1417670|NCT01119131|Secondary|Change in Parkinsonism as Measured by the UPDRS|This is the motor subsection of the UPDRS and is a commonly used tool to rate the symptoms of Parkinson‘s disease. This scale rates from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. A sum score represents motor function with higher values on this scale represent a more severe stage of the disease. Change is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in Parkinson's motor symptoms.|Baseline, 16 weeks|Missing data (N = 2), invalid sum due to missing rating (N = 1), not completed due to scheduling conflicts (N = 1).|||units on a scale||Standard Deviation|Mean
1417671|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).|||foot pounds||Standard Deviation|Mean
1417672|NCT01119131|Primary|Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In 4-6 the base moves and the subject has eyes open, then closed, then the visual surround moves. SOT 4-6 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=3, test not performed due to participant fatigue (N = 2) or computer/mechanical error (N = 1).|||units on a scale||Standard Deviation|Mean
1417673|NCT01119131|Secondary|Change in Quality of Life as Recorded Using Quality of Life Scales (PDQ39)|"The PDQ39 is a 39 item patient completed survey targeting well-being and functioning in PD. This scale address 8 dimensions (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort). The PDQ39 dimension scores are on a scale of 0 (Never) to 4 (Always/Cannot Do). Scale scores are summed and range from 0 to 100 with 100 being the maximum level of problems. For a single index figure to characterize the impact of Parkinson’s disease upon PD patients (PDSI), all 39 items of the PDQ39 can be summed. The PDQ39 and the use of a PDSI have shown adequate reliability and convergent validity. Change score is measurement at 16 weeks minus baseline measurement, negative scores indicate an improvement in quality of life."|Baseline, 16 weeks|Missing data (N = 3), patient forgot form and did not return mailed form (N = 3).|||units on a scale||Standard Deviation|Mean
1417674|NCT01119131|Secondary|Change in Cognition (Trail Making Test B-A)|The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B is theorized to reduce the influence of the working memory and visuospatial demands and, therefore, provides a relatively pure indicator of executive function. Change score is measurement (Part B - Part A) at 16 weeks minus measurement (Part B - Part A) at baseline, negative scores indicate a improvement in executive functioning.|Baseline, 16 weeks|Missing data (N = 8) due to scheduling difficulties (N = 3), neuropsychological administration errors (N = 2), patient discontinuing (N = 1), maximum time allowance met and discontinued test (N = 2).|||seconds||Standard Deviation|Mean
1417675|NCT01119131|Primary|Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work)|Defined as the total muscular force output for the repetition with the greatest amount of work. The equation for work is: W = F x D. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=4, test not performed due to participant fatigue (N = 2), mechanical/computer issues (N = 1), illness of operator (N = 1).|||foot pounds||Standard Deviation|Mean
1417676|NCT01119131|Primary|Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration|"This is a test that measures ambulatory balance and mobility. The instrumented timed up and go (iTUG) is an average time (seconds) of three trials that involve the participant arising from a chair, walking 25 feet turning around, walking back to the chair, and sitting down. The turn duration is the average time to turn at the end of the 25 foot walk. Longer duration of time (seconds) indicates more rigidity, a proxy measure for ON time in Parkinson’s disease. Change score is measurement at 16 weeks minus measurement at baseline."|Baseline and 16 weeks|Missing data N=14, test not performed due to either participant fatigue (N = 2) or mechanical/computer issues (N = 12).|||seconds||Standard Deviation|Mean
1417716|NCT01118845|Secondary|Concomitant Medication Usage||up to 30 weeks||||Participants|||Number
1417677|NCT01119131|Primary|Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3)|Sensory organization test (SOT) is a form of posturography. which is designed to assess quantitatively an individual`s ability to use visual, proprioceptive and vestibular cues to maintain postural stability in stance. The SOT measures sway during 6 scenarios. In scenarios 1-3 the base is stable and eyes are open, then closed, and then the visual surround moves. SOT 1-3 is an average measurement of equilibrium - the average center of gravity sway for each condition. It generates a score of 0 (fall) up to 100 for each scenario and an overall composite score. Change score is measurement at 16 weeks minus measurement at baseline.|Baseline, 16 weeks|Missing data N=2, test not performed due to participant fatigue.|||units on a scale||Standard Deviation|Mean
1417678|NCT01119118|Secondary|Number of Subjects With PSA Response||6 months||||participants|||Number
1417679|NCT01119118|Secondary|Number of Subjects Whose Tumor Lesion Size Changed Using Iterative Decomposition of Water and Fat With Echo Asymmetry and Least-squares Estimation (IDEAL)-MRI Imaging Alone||Week 6||||participants|||Number
1417680|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Diffusion-weighted Imaging (DWI)-Magnetic Resonant Imaging (MRI) Alone||Week 6||||participants|||Number
1417681|NCT01119118|Secondary|The Number of Subjects Whose Tumor Lesion Size Changed Using Positron Emission Tomography (PET) Imaging Alone.||Week 6||||participants|||Number
1417682|NCT01119118|Primary|The Number of Subjects Whose Tumor Lesion Size Changed After 6 Weeks of Treatment With ZD4054 Using PET and MRI Scans.|Multimodal Positron Emission Tomography (PET) and Magnetic Resonant Imaging (MRI) imaging were used to evaluate changes in the tumor lesion size following 6 weeks of treatment with ZD4054.|Week 6||||participants|||Number
1417683|NCT01119040|Primary|Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.|Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.|30 day follow-up|Only 1 subject due to low accrual|||participants|||Number
1417684|NCT01119001|Primary|Accuracy of Typing With a BCI Keyboard by ALS Patients.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.~Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|3 times over 2-4 weeks||||percentage accuracy||Full Range|Mean
1417685|NCT01118988|Secondary|Positive and Negative Affect Scale (PANAS)|"assesses extent to which children have felt a number of positive and negative affects~Positive Affect subscale, 12 items, range: 12-60, higher score = more positive affect Negative Affect subscale, 15 items, range: 15-75, higher score = more negative affect"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417686|NCT01118988|Secondary|Child Health Questionnaire - Child Report (CHQ)|"detailed questionnaire about health, daily activites, pain, behavior, family health, self-esteem~Subscales (for all subscales, higher scores = better health):~Behavior - 16 items, averaged, range 1-5 Bodily Pain and Discomfort - 2 items, averaged, range 1-6 Change in Health - 1 item, range 1-5 Family Activities - 6 items, averaged, range 1-5 Family Cohesion - 1 item, range 1-5 Global Health - 1 item, range 1-5 Global Behavior - 1 item, range 1-5 General Health - 12 items, averaged, range 1-5 Mental Health - 16 items, averaged, range 1-5 Physical Functioning - 9 items, averaged, range 1-4 Role/Social Limitations Behavioral - 3 items, range 1-4 Role/Social Limitations Emotional - 3 items, range 1-4 Role/Social Limitations Physical - 3 items, range 1-4 Self-Esteem - 14 items, range 1-5"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417687|NCT01118988|Secondary|Beck Depression Inventory 2 (BDI-2) #18|"assesses suicidal ideation and intent~Number reported is number of participants who reported any level of suicidal ideation or intent at any time and who were followed with the study's emergency protocol to ensure that such participants are not a threat to self or others, and that he/she was under the appropriate mental health care."|baseline, weekly weeks 1-8, 2 months, 4 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||participants|||Number
1417688|NCT01118988|Secondary|Revised Child Anxiety and Depression Scale (RCADS) Child Report|"assess levels of symptoms for anxiety disorders and depression~Range: 0-141; Higher scores mean higher symptom level of anxiety and depression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417689|NCT01118988|Secondary|Functional Disability Inventory (FDI)|"assesses functional disability for daily tasks~Range: 0-60; higher scores mean greater functional disability."|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417690|NCT01118988|Secondary|Emotion Expression Scale for Children (EESC)|"assess child emotional expression/emotion regulation~Poor Awareness subscale, 8 items, range: 8-40; higher scores = poorer emotional awareness Expressive Reluctance subscale, 8 items, range: 8-40; higher scores = more expressive reluctance"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417691|NCT01118988|Secondary|Emotion Regulation Questionnaire (ERQ) - Child Answer|"assessment of child emotion regulation~Reappraisal subscale: 6 items, range 6-30, higher scores = higher use of reappraisal Suppression subscale: 4 items, range: 4-20, higher scores = higher use of suppression"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417695|NCT01118988|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"assessment of sleep quality~Range: 0-21; higher scores = lower sleep quality"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||units on a scale||Standard Deviation|Mean
1417696|NCT01118988|Secondary|Body Map and Pain Assessment|"visual depiction of body pain and associated pain ratings over certain periods of time and conditional situations~Range: 0-19 body areas"|2 months|Not all participants who completed the intervention completed this measure, so the numbers reported herein are lower than those reported in Participant Flow.|||Number of painful body areas||Standard Deviation|Mean
1417697|NCT01118988|Primary|Adherence to Physician Recommended CAM Therapies|This measure tracks the attendance of CAM therapies recommended by the subjects' pain specialist physician.|post intervention (week 8)|One participant in the Mentorship group did not do the weekly CAM therapy tracking and is thus not included in the results for this measure.|||Visits to CAM therapists per week||Standard Deviation|Mean
1417698|NCT01118975|Primary|Clinical Benefit Rate|The Clinical Benefit Rate is the number of patients with either Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for ≥ 6 months|Radiological evaluations are performed every 12 weeks to determine disease status||||participants|||Number
1417699|NCT01118975|Primary|Dose Limiting Toxicities|Safety and tolerability were assessed. Adverse events and dose limiting toxicities were recorded during an escalting dose pilot phase.|6 weeks||||Dose limiting toxicities|||Number
1417700|NCT01118962|Primary|Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."|||participants|||Number
1417701|NCT01118962|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)||From Visit 1 to the end of study (Approximately 61 weeks)|"Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.~The SS consists of all subjects that were dosed at least once with Lacosamide (LCM)."|||participants|||Number
1417702|NCT01118949|Secondary|Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.|||participants|||Number
1417703|NCT01118949|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|From Visit 2 (Week 4) to Visit 7 (Week 13)|All 49 subjects in the Safety Set (SS) are included in this analysis.|||participants|||Number
1417704|NCT01118949|Secondary|Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.|||1/hour||Standard Deviation|Mean
1417705|NCT01118949|Secondary|Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)|Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.|From Visit 2 (Week 4) to Visit 6 (Week 8)|Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.|||1/hour||Standard Deviation|Mean
1417706|NCT01118949|Primary|Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:~Seizure type~Seizure frequency~A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.|||number of seizure days||Standard Deviation|Mean
1417707|NCT01118949|Primary|Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase|"During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:~Seizure type~Seizure frequency~A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures."|From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)|Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.|||number of seizure days||Standard Deviation|Mean
1417708|NCT01118845|Secondary|The Half-life Period (t1/2) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
1417709|NCT01118845|Secondary|The Area Under the Curve (AUC) for Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||ng・h/mL||Standard Deviation|Mean
1417710|NCT01118845|Secondary|The Maximum Drug Concentration Time (Tmax) of Unchanged SyB L-0501 in Korea||Prior to and 30 min after start of administration, and 0, 30, 60, 120 min after completion of administration on Day 2 of the 1st cycle||||hour||Standard Deviation|Median
1417718|NCT01118845|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE).~grade 1 : mild grade 2 : moderate grade 3 : severe grade 4 : life threatening or disabling grade 5 : death related to adverse event"|up to 30 weeks||||Participants|||Number
1417719|NCT01118845|Secondary|Number of Adverse Events||up to 30 weeks||||Events|||Number
1417720|NCT01118845|Secondary|Number of Subjects With Adverse Event||up to 30 weeks||||Participants|||Number
1417721|NCT01118845|Secondary|Progression Free Survival (PFS)|"PFS = day of the first PFS event - day of start of study treatment + 1~The definitions of PFS event are as below.~PD according to overall response on the basis of Revised Response Criteria for Malignant Lymphoma~PD: Any new lesion or increase by ≥50% of previously involved sites from nadir. Nodal masses; Appearance of a new lesion(s) >1.5 cm in any axis, ≥50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node >1 cm in short axis. Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Spleen, Liver; ≥50% increase from nadir in the SPD of any previous lesions. Bone marrow; New or recurrent involvement~Disease progression during treatment period~Disease progression during follow up period~Start of treatment of new lesion~Occurrence of other multiple malignant tumors~Death"|up to 30 weeks||||Days||95% Confidence Interval|Median
1417722|NCT01118845|Secondary|The Complete Response (CR) Rate Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"The criteria for CR is as below~Nodal Masses:~fluorodeoxy glucose (FDG)-avid or positron emission tomography (PET) positive prior to therapy; mass of any size permitted if PET negative~Variably FDG-avid or PET negative; regression to normal size on computed tomography (CT)~Spleen, Liver:~Not palpable, nodules disappeared~Bone Marrow:~Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative"|up to 30 weeks||||Percentage of participants||95% Confidence Interval|Number
1417723|NCT01118845|Primary|The Overall Response Rate [Complete Response (CR) + Partial Response (PR)] Determined on the Basis of Revised Response Criteria for Malignant Lymphoma|"CR: Disappearance of all evidence of disease. PR: Regression of measurable disease and no new sites.~For the criteria for CR, See Outcome measure 2 description.~The criteria for PR is as below.~Nodal Masses:~more than 50% decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT~Spleen, Liver:~more than 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen~Bone Marrow:~Irrelevant if positive prior to therapy; cell type should be specified"|up to 30 weeks||||Percentage of Participants||95% Confidence Interval|Number
1417724|NCT01118780|Secondary|Time to First Improvement|The time (days) to first improvement, defined as a Clinical Global Impression of Improvement (CGI-Improvement) Score ≤2. Participants who did not have a CGI-I Score ≤2 were censored at the last treatment period visit. CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). A CGI-Improvement Score of ≤2 was much improved or very much improved.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=37 participants in the duloxetine treatment arm and n=58 participants in the placebo treatment arm.|||days||95% Confidence Interval|Median
1417725|NCT01118780|Secondary|Time to First Functional Remission|Time (days) to first functional remission. Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). Participants, who did not have an SDS Global Score ≤5 or ≤6, were censored at the last treatment period visit. The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Baseline through 10 weeks|All randomized participants (pts). Number of pts censored (n)=50 pts in duloxetine treatment arm and n=73 pts in placebo treatment arm for time to first functional remission (SDS Global Score ≤5) and n=37 pts in duloxetine treatment arm and n=60 pts in placebo treatment arm time to first functional remission (SDS Global Score ≤6).|||days||95% Confidence Interval|Median
1417726|NCT01118780|Secondary|Time to Sustained Improvement Overall|Time (days) to the earliest visit at which the Hamilton Anxiety Rating Scale (HAMA) Total Score was a ≥30% improvement (reduction) from baseline that was sustained through the last treatment period visit. Participants who did not meet sustained improvement criteria were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of participants censored (n)=43 participants in the duloxetine treatment arm and n=63 participants in the placebo treatment arm.|||days||95% Confidence Interval|Median
1417727|NCT01118780|Secondary|Time to First Remission|The time (days) to first remission. Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score, were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). Participants who did not have remission were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants (pts). The number of censored pts (n)=72 pts in the duloxetine treatment arm and n=92 pts in the placebo treatment arm for time to first remission (HAMA Total Score ≤7) and n=49 pts in the duloxetine treatment arm and n=71 pts in the placebo treatment arm for the time to first remission (HAMA Total Score ≤10).|||days||95% Confidence Interval|Median
1417728|NCT01118780|Secondary|Time to First Response|The time (days) to first response, defined as a ≥50% improvement (reduction) from baseline in the Hamilton Anxiety Rating Scale (HAMA) Total Score. Participants who did not have a response were censored at the last treatment period visit. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline through 10 weeks|All randomized participants. The number of censored participants (n)=36 participants in the duloxetine treatment arm and n=60 participants in the placebo treatment arm.|||days||95% Confidence Interval|Median
1417729|NCT01118780|Other Pre-specified|Number of Participants Experiencing a Treatment-Emergent Adverse Event (AE) During the Taper Period|Treatment-emergent AEs were newly occurring AEs or a worsening of AEs during the taper period. A summary of serious AEs and other AEs during the treatment period (baseline through 10 weeks) is located in the Reported Adverse Events module.|2 weeks during the taper period|Randomized participants who entered the taper period.|||participants|||Number
1417730|NCT01118780|Secondary|Percentage of Participants Reporting Falling Down|The percentage of participants who reported 1 or more falls at or before Week 10.|Baseline through 10 weeks|Randomized participants with no falls recorded at Baseline and at least 1 post-baseline assessment for falls.|||percentage of participants|||Number
1417731|NCT01118780|Secondary|Adverse Events (AEs) Leading to Discontinuation From Study|The number of participants who discontinued from the study due to an AE (serious or other AE) during the treatment period. A summary of serious and other AEs is located in the Reported Adverse Events module.|Baseline through 10 weeks|All randomized participants.|||participants|||Number
1417732|NCT01118780|Secondary|Percentage of Participants With Sustained Improvement (Sustained Improvement Rate)|Two definitions, using the Hamilton Anxiety Rating Scale (HAMA) Total Score at endpoint compared with baseline, were used to determine sustained improvement: Definition 1 [sustained improvement overall required a ≥30% improvement (reduction) in the HAMA Total Score at treatment period endpoint, at an earlier visit prior to endpoint, and at all visits in between] and Definition 2 (sustained improvement from Week 2 required a ≥30% reduction at treatment period endpoint, at Week 2, and at all visits in between). Both definitions required at least 2 post-baseline visits. The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|(Baseline through 10 weeks) and (Baseline, Week 2 through Week 10)|Randomized participants who had baseline and the required number of post-baseline HAMA Total Scores.|||percentage of participants|||Number
1417733|NCT01118780|Secondary|Percentage of Participants With Functional Remission at Week 10 (Functional Remission Rate)|Two definitions, using the Sheehan Disability Scale (SDS) Global Functional Impairment Score (SDS Global Score), were used to determine functional remission: Definition 1 (SDS Global Score ≤5 at endpoint) and Definition 2 (SDS Global Score ≤6 at endpoint). The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Score was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life.|Week 10|All randomized participants with at least 1 post-baseline SDS Global Score; Last observation carried forward (LOCF).|||percentage of participants|||Number
1417734|NCT01118780|Secondary|Percentage of Participants With Response or Remission at Week 10 (Response and Remission Rates)|Response was a ≥50% improvement (reduction) in the Hamilton Anxiety Rating Scale (HAMA) Total Score at treatment period endpoint compared with baseline. Two definitions were used to determine remission: Definition 1 (HAMA Total Score ≤7 at endpoint) and Definition 2 (HAMA Total Score ≤10 at endpoint). The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity.|Baseline, Week 10|Randomized participants with a baseline and 1 post-baseline HAMA Total Score; Last observation carried forward (LOCF).|||percentage of participants|||Number
1417735|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Work/School, Social Life, and Family/Home Management Individual Impairment Scores|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Work/School, Social Life/Leisure Activities, or Family/Home Management Individual Impairment Scores.|||units on a scale||Standard Error|Least Squares Mean
1417736|NCT01118780|Secondary|Number of Participants With Treatment-Emergent Suicide-Related Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent was the worsening or new occurrence of suicidal behavior or ideation during treatment compared with baseline (Week 0)."|Baseline through 10 weeks|Randomized participants with a baseline and at least 1 post-baseline C-SSRS Score.|||participants|||Number
1417803|NCT01118273|Secondary|Global Assessment of Study Medication as a Sleep-aid|Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417737|NCT01118780|Secondary|Change From Baseline to Week 10 in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Total Score|The Q-LES-Q-SF was a participant-rated questionnaire designed to assess the degree of enjoyment and satisfaction experienced during the past week. The questionnaire consisted of 16 items rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total raw score was the sum of Items 1 to 14 and could have ranged from 14 to 70. Total raw scores were converted to, and expressed as, the percentage of the maximum possible score. Percent=100*(total raw score – 14)/56. Higher scores indicated higher levels of enjoyment/satisfaction. Least squares (LS) mean were calculated and analyzed using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator, age category, and baseline.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; Last observation carried forward (LOCF).|||percent of maximum possible score||Standard Error|Least Squares Mean
1417738|NCT01118780|Secondary|Change From Baseline to Week 10 in Brief Pain Inventory-Modified Short Form (BPI-SF) Pain Severity and Interference Subscales|The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions assessing worst pain, least pain, and average pain in the past 24 hours, and pain right now. The BPI-SF Interference Subscale measured the interference of pain with the participant's ability to function. Interference scores could have ranged from 0 (does not interfere) to 10 (completely interferes) for questions assessing interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least squares (LS) means were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline BPI-SF Pain Severity or Interference Subscale Score.|||units on a scale||Standard Error|Least Squares Mean
1417739|NCT01118780|Secondary|Patient's Global Impressions of Improvement Scale (PGI-Improvement) at Week 10|PGI-Improvement measured the participant's perception of his or her improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much better) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline PGI-Improvement Score.|||units on a scale||Standard Error|Least Squares Mean
1417740|NCT01118780|Secondary|Clinical Global Impressions of Improvement Scale (CGI-Improvement) at Week 10|CGI-Improvement measured the clinician's perception of the participant's improvement at the time of assessment compared with the start of treatment. Scores could have ranged from 1 (very much improved) to 7 (very much worse). Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit.|Week 10|Randomized participants with at least 1 post-baseline CGI-Improvement Score.|||units on a scale||Standard Error|Least Squares Mean
1417741|NCT01118780|Secondary|Change From Baseline to Week 10 Endpoint in Hospital Anxiety Depression Scale (HADS) Subscale Scores|HADS was a 14-item questionnaire with 2 subscales (anxiety and depression). Each item was rated on a 4-point scale (0 to 3) and higher scores indicated a greater dysfunction. The HADS Anxiety Subscale Score was the sum of the odd numbered items and scores could have ranged from 0 to 21. The HADS Depression Subscale Score was the sum of the even numbered items and scores could have ranged from 0 to 21. Higher scores indicated a greater dysfunction. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HADS Subscale Score.|||units on a scale||Standard Error|Least Squares Mean
1417742|NCT01118780|Secondary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) (Psychic Anxiety Factor Score, Somatic Anxiety Factor Score, and Individual Item Scores: Anxious Mood Item and Tension Item)|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Psychic Anxiety Factor Score was the sum of Items 1 to 6 and Item 14 and could have ranged from 0 to 28. The HAMA Somatic Anxiety Factor Score was the sum of Items 7 to 13 and could have ranged from 0 to 28. The HAMA Anxious Mood Item Score was the score for Item 1 and the HAMA Tension Item Score was the score for Item 2. In each case, higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA factor or item score.|||units on a scale||Standard Error|Least Squares Mean
1417743|NCT01118780|Secondary|Change From Baseline to Week 10 in Sheehan Disability Scale (SDS) Global Functional Impairment Score|The SDS was a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated a higher functional impairment in the participant's work/social/family life. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline SDS Global Functional Impairment Score.|||units on a scale||Standard Error|Least Squares Mean
1417758|NCT01118455|Secondary|Number of Subjects With Any Serious Adverse Events by System Organ Class & Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks||||participants|||Number
1417744|NCT01118780|Primary|Change From Baseline to Week 10 in Hamilton Anxiety Rating Scale (HAMA) Total Score|The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) was used to collect HAMA data. The HAMA consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAMA Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Least squares (LS) mean were calculated and analyzed using mixed-model repeated measures (MMRM) adjusted for treatment, pooled investigator, age category, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|Randomized participants with a baseline and at least 1 post-baseline HAMA Total Score.|||units on a scale||Standard Error|Least Squares Mean
1417745|NCT01118741|Secondary|Clinical Response|"To assess the clinical response measured by prostate specific antigen (PSA) progression at 6 months after treatment with the defined dose of disulfiram in prostate cancer (PCa) patients with evidence of biochemical relapse after local therapy. Reported as number of participants with PSA progression by 6 months.~Criteria used to assess: A rise in PSA noted at 6 months, greater than 50% over PSA value at baseline and > 2 ng/ml, above the nadir. The rise was confirmed by a second PSA value obtained at least 1 week from that reference value."|Up to 6 months||||participants|||Number
1417746|NCT01118741|Primary|Proportion of Subjects With a Demethylation Response at Each Dose Level|For both of the doses explored (i.e. disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed. A demethylation response was defined as a >=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.|24 months||||proportion of participants||95% Confidence Interval|Number
1417747|NCT01118728|Secondary|Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20)|Treatment response for ASAS20 was defined as: Improvement of ≥ 20% and ≥ 1 unit on a 0 (least) to 10 (worst) numerical rating score (NRS) in at least 3 of the 4 ASAS improvement criteria (ASASIC) domains, and no worsening of ≥ 20% and ≥ 1 unit on 0-10 NRS in the remaining domain. The 4 domains included were participant's global disease activity assessment, total back pain, physical function (Bath Ankylosing Spondylitis Functional Index), and Inflammation (mean of last 2 Bath Ankylosing Spondylitis Disease Activity Index questions on morning stiffness).|Baseline up to the end of treatment (60 weeks)|Analysis was performed on safety population. Number of participants analyzed=participants with ASAS20 assessment at specified time-points. Here 'n' signifies number of participants with available data for specified time-point.|||Percentage of participants|||Number
1417748|NCT01118728|Primary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation|An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period).|Baseline up to the end of study (66 weeks)|Analysis was performed on safety population defined as all participants who received at least one dose of the study treatment after signature of the informed consent.|||Percentage of participants|||Number
1417749|NCT01118663|Secondary|To Evaluate the Incidence of Anaphylactoid Reaction.|Data analysis was conducted on the subjects enrolled in the study prior to study termination. Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|1 hour||||participants|||Number
1417750|NCT01118663|Secondary|To Evaluate the Incidence of Treatment Emergent Adverse Events||21-42 hours||||Number of Events|||Number
1417751|NCT01118663|Secondary|To Evaluate the Incidence of Clinical Need for Therapy Beyond the Current 21 Hour FDA Approved Dosing Regimen.|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|42 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.||||||
1417752|NCT01118663|Secondary|To Evaluate the Percentage of Subjects Requiring Continued Therapy|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.||||||
1417753|NCT01118663|Primary|The Incidence of Hepatoxicity as Measured by the Percentage of Subjects With an Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Value > 1000 U/L Versus Those With an ALT and AST < 1000 U/L|Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.|21 hours|Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.||||||
1417754|NCT01118624|Secondary|Incidence of Adverse Events (AEs) and Laboratory Abnormalities||Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal).||||participants|||Number
1417755|NCT01118624|Secondary|Overall Survival (OS)|Number of days from first dose of pralatrexate to death.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate.||||months||95% Confidence Interval|Median
1417756|NCT01118624|Secondary|Duration of Response (DOR)|One patient has a PR as response and duration of response was provided for that patient.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.||||days|||Number
1417757|NCT01118624|Primary|Objective Response Rate (ORR)|Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.||||participants|||Number
1417759|NCT01118455|Secondary|Number of Subjects With Any Non-Serious Adverse Events by System Organ Class and Preferred Term (Safety Population)|"To compare the safety of Vagus Nerve Stimulation (VNS) treatment using the VNS Therapy device to anti-epileptic drug (AED) therapy in treating patients with seizures.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|0-52 weeks|"Number of participants with any definite related Adverse Event by body system and preferred term, Safety Population.~NOTE: Number of participants analyzed in VNS arm includes one explant not from ITT population, but from safety population."|||Participants|||Number
1417760|NCT01118455|Secondary|Mean Percent Change in Seizure Frequency (ITT Population)|"The mean percent change in seizure frequency for the VNS and AED treatment groups at 52 weeks post baseline.~Both AED and VNS treatment groups were stratified according to the patients' number of previous AED treatments (early group had 2 to 5 AEDs tested to tolerance or to blood levels at upper end of target range; non-early group had more than 5 AEDs tested to tolerance or to blood levels at upper end of target range). Seizure frequency was calculated based on number of patient/caregiver reported seizures at 52-week post baseline (percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%). All seizures were counted.~The safety population consists of 66 VNS implanted patients and the AED safety population includes 69 patients who are randomized to the AED arm.~Please note one patient in the VNS safety population who was implanted but never received stimulation was excluded from the ITT population."|52 weeks post baseline||||Percent Change||Standard Deviation|Mean
1417761|NCT01118455|Secondary|Hague Restriction in Childhood Epilepsy Scale (Questionnaire B) (ITT Population)|"Calculate changes in the Hague Restriction in Childhood Epilepsy scale (Carpay et al. 1997) (Questionnaire B) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.~An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.~Total range for this scale is a minimum score of 10 to a maximum score of 40. There are no applicable subscales."|52 weeks post baseline||||Scores on a Scale||Standard Deviation|Mean
1417762|NCT01118455|Secondary|Wellcome Quality of Life Assessment (Questionnaire A) in Epilepsy (ITT Population)|"Calculate changes in the Wellcome Quality of Life Assessment (Parker et al. 1999) (Questionnaire A) for patients in both treatment arms (AED and VNS) at 52 weeks after randomization compared to baseline. The higher the quality of life score the better the quality of life experienced.~An analysis of variance (ANOVA) model will be used to adjust for baseline variables (including QoL score) when comparing the two treatment groups. A two-sample t-test will be used for simple comparison QoL change from baseline.~Total range for this scale is a minimum score of 81 to a maximum score of 336. There are no applicable subscales."|52 weeks post baseline||||Scores on a Scale||Standard Deviation|Mean
1417763|NCT01118455|Secondary|Mean Percent Change in Hague Seizure Severity Scale Score (ITT Population)|The Hague Seizure Severity Assessment (Carpay et al. 1996) is a scale completed by the patient and/or caregiver to assess the severity and post-ictal recovery of seizures. A reduction in the HSSA score reflects less seizure severity experienced.|52 weeks post baseline||||Percent Change||Standard Deviation|Mean
1417764|NCT01118455|Primary|Proportion of Responders After 1 Year of Follow-up (ITT-population)|Responders are subjects who had no new AEDs added or significant dose changes in baseline AEDs within 1 year of follow-up, along with a reduction in the percentage change in seizure frequency from baseline to the 2-month period prior to the 1-year follow-up of at least 50%.|52 weeks post baseline|Subjects were stratified based on AED therapy history (Early: treated with 2 to 5 AEDs versus Non-early: treated with >5 AEDs).|||percentage of responders|||Number
1417765|NCT01118377|Secondary|Percentage of Participants With a Tumor Response|Tumor response was defined as either a complete response or a partial response prior to failure (disease progression, death from any cause, or a second malignancy). A complete response was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. A partial response was defined as a greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.|||Percentage of participants||95% Confidence Interval|Number
1417766|NCT01118377|Secondary|Overall Survival|Overall survival was defined as the time from the initiation of therapy to the date of death from any cause or to the date the patient was last known to be alive for surviving patients.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.|||Months||95% Confidence Interval|Median
1417767|NCT01118377|Primary|Progression-free Survival|Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.|Baseline to the end of the study (up to 20 weeks)|Intent-to-treat population: All enrolled participants who received at least 1 dose of capecitabine.|||Months||95% Confidence Interval|Median
1417768|NCT01118325|Secondary|AR-C124910XX (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||hour||Full Range|Median
1417769|NCT01118325|Secondary|AR-C124910XX (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||ng.h/mL||Standard Deviation|Geometric Mean
1417770|NCT01118325|Secondary|AR-C124910XX (Cmax) at Week 4|Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||ng/mL||Standard Deviation|Geometric Mean
1417771|NCT01118325|Secondary|AZD6140 (Tmax) at Week 4|Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||hour||Full Range|Median
1417772|NCT01118325|Secondary|AZD6140 (AUC0-tau) at Week 4|Area under the plasma concentration curve of AZD6140 from time zero to dosing interval|Week 4|In total 7 Japanese patients (4 patients in 45 mg and 3 patients in 90 mg) were excluded from the PK analysis set since PK samples of these patients were discarded due to a database set-up issue at the central laboratory.|||ng.h/mL||Standard Deviation|Geometric Mean
1417773|NCT01118325|Secondary|AZD6140 (Cmax) at Week 4|Maximum plasma AZD6140 concentration|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis|||ng/mL||Standard Deviation|Geometric Mean
1417774|NCT01118325|Primary|IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
1417775|NCT01118325|Primary|IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
1417776|NCT01118325|Primary|IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
1417777|NCT01118325|Primary|IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
1417778|NCT01118325|Primary|Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients|"Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation:~Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit."|Week 4|Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan|||percentage inhibition||Standard Deviation|Mean
1417779|NCT01118312|Secondary|Childhood Asthma Control Test|Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control|24 weeks|Analysis of Children (less than 18 years old) Childhood Asthma Control Test scores|||units on a scale||Standard Error|Mean
1417780|NCT01118312|Primary|Asthma Control Test (ACT)|Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control|24 weeks|Analysis of adult (18 and above) Asthma Control Scores|||units on a scale||Standard Error|Mean
1417781|NCT01118273|Secondary|Wake Episode Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).|Up to 10 hours||||Wake episodes||95% Confidence Interval|Least Squares Mean
1417782|NCT01118273|Secondary|Activity Mean Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Activity mean - average movement per minute.|Up to 10 hours|ITT (Intent to Treat) Population|||Movement per minute||95% Confidence Interval|Least Squares Mean
1417885|NCT01117623|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose level, which could be given to 6 participants such that no more than 1 participant (less than 33%) experienced a dose-limiting toxicity (DLT).|Within first 4 weeks of treatment|Safety Population; dose escalation cohorts only|||mg|||Number
1417783|NCT01118273|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Percentage of sleep time||95% Confidence Interval|Least Squares Mean
1417784|NCT01118273|Secondary|Total Wake Time Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1417785|NCT01118273|Secondary|Number of Times Participants Took Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
1417786|NCT01118273|Secondary|Global Assessment of Study Medication as a Pain Reliever|Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
1417787|NCT01118273|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
1417788|NCT01118273|Secondary|Time to Rescue Medication|"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment."|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
1417789|NCT01118273|Secondary|Overall Rating of Pain Relief|"Subjects responded to question, Overall, the relief from my starting pain was by checking one of the following choices: no relief (0), a little relief (1), some relief (2), a lot of relief (3), complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
1417790|NCT01118273|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score|Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1417791|NCT01118273|Secondary|Overall Rating of Severity in Visual Analog Scale (VAS) Score|Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.|At 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
1417792|NCT01118273|Secondary|Change From Baseline in Categorical Pain Rating Scale Score|Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1417793|NCT01118273|Secondary|Overall Rating of Severity in Categorical Pain Rating Scale Score|Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).|Up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
1417794|NCT01118273|Secondary|Sleep Quality Index|Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed).|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1417795|NCT01118273|Secondary|Total Sleep Time by Subject Assessment|Subject responded to: Please estimate the number of hours and minutes you think that you slept.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1417796|NCT01118273|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417797|NCT01118273|Secondary|Karolinska Sleep Diary - Well Rested|Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417798|NCT01118273|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417799|NCT01118273|Secondary|Karolinska Sleep Diary - Premature Awakening|Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417800|NCT01118273|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417801|NCT01118273|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417802|NCT01118273|Secondary|Karolinska Sleep Diary - Sleep Quality|Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
1417804|NCT01118273|Secondary|Sleep Latency Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1417805|NCT01118273|Secondary|Wake After Sleep Onset (WASO) Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1417806|NCT01118273|Primary|Total Sleep Time Measured by Actigraphy|Actigraphy is a non-intrusive tool that measures an individual’s movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as “awake” from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
1417807|NCT01118221|Secondary|Maximum Oxygen Uptake|Change in 6 peak O2 uptake from Baseline to 3 Months|Maximum O2 uptake will be measured at 0 and 3 months.||||mL/minute||Standard Error|Mean
1417808|NCT01118221|Secondary|Systemic Markers of Oxidant Stress|Plasma F2-isoprostanes measured in all subjects before and after exercise testing at baseline.|Markers of oxidant stress will be measured in all subjects before randomization after exercise testing at 0 months.||||pg/mL||Standard Deviation|Mean
1417809|NCT01118221|Primary|6 Minute Walk Distance|Change in 6 Minute Walk Distance from Baseline to 3 Months|The 6-MWD will be measured at 0 and 3 months.||||meters||Standard Deviation|Mean
1417810|NCT01118143|Secondary|Plaque Index|"The plaque index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = low accumulation of plaque; 1.1-2.0 = Moderate accumulation of plaque; 2.1-3.0 = high accumulation of plaque.~The Plaque index reference is Silness and Löe, 1964."|6 months after intervention||||units on a scale||Standard Deviation|Mean
1417811|NCT01118143|Primary|Gingival Index|The gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.|6 months after intervention||||units on a scale||Standard Deviation|Mean
1417812|NCT01118117|Secondary|Stent Fracture at 12 Months|Occurrence of stent fracture as determined by core laboratory analysis|12 Months post-procedure|X-rays for 324 stents (234 subjects) were available for analysis by the angiographic core laboratory to evaluate stent fractures at 12 months post-procedure. One stent fracture was caused by a physician during a non-study peripheral intervention.|||percentage of fracture occurrence|stents||Number
1417813|NCT01118117|Secondary|Major Adverse Events (MAEs) Through 12 Months Post-procedure|The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death.|12 Months post-procedure||||percentage of subjects with event|||Number
1417814|NCT01118117|Secondary|Clinical Success|Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline|30 days post-procedure||||percentage of subjects with success|||Number
1417815|NCT01118117|Secondary|Procedural Success|Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel|Intra-procedure||||percentage of subjects with success|||Number
1417816|NCT01118117|Secondary|Technical Success|"Technical Success defined by the following conditions:~Successful delivery of the stent at the lesion site~Stent(s) successfully deployed in lesion with adequate lesion coverage"|Intra-procedure|All subjects enrolled in pivotal trial|||percentage of subjects with success|||Number
1417817|NCT01118117|Secondary|Device Related Peri-Procedural Complications|Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion)|Prior to Hosptial Discharge|All enrolled participants evaluated prior to hospital discharge|||percentage of subjects with event|||Number
1417818|NCT01118117|Secondary|Occurrence of Target Lesion Revascularization|"The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure.~Clinically driven defined as:~More than 50 percent stenosis with worsening symptoms, OR~More than 70 percent stenosis without symptoms"|12 Months post-procedure|Comprised of all subjects enrolled in the pivotal OSPREY trial (N=261)|||percentage of subjects with TLR|||Number
1417819|NCT01118117|Secondary|Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort|The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint)|12 Months post-procedure|Analysis uses a more contemporary approach to evaluate primary stent patency using a peak systolic velocity ratio ≤ 2.4 (modified VIVA criteria). Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success in the analysis.|||percentage of stent patency|||Number
1418319|NCT01114438|Primary|Changes in Diabetic Medications at Treatment Completion Compared to Baseline|number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)|12 months|Analysis was conducted on subjects with a device|||Participants|||Count of Participants
1417820|NCT01118117|Primary|Primary Safety Endpoint|The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death.|30 days post-procedure|Study success was based on the proportion of patients with freedom from MAE at 30 days post-procedure when tested against a performance goal of 88% using the lower bound of the 95% confidence interval. In both cohorts, the lower confidence interval exceeded the prespecified performance goal indicating the study met its primary safety endpoint.|||percentage of subjects without a MAE||95% Confidence Interval|Number
1417821|NCT01118117|Secondary|Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort|Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).|12 Months post-procedure|The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint).|||percentage of stent patency|||Number
1417822|NCT01118117|Primary|Primary Effectiveness Endpoint|The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window.|12 Months post-procedure|Analysis comprised of 261 subjects enrolled in pivotal trial and missing data imputed as loss of patency under the intention-to-treat (ITT) analysis. Study success was based on the proportion of patients with stent patency when tested against a performance goal of 66% using the lower bound of the 95% confidence interval.|||percentage of stent patency||95% Confidence Interval|Number
1417823|NCT01118091|Primary|Progression Free Survival|Measured from the time of randomization to time of progression (or death).|3 years||||Days|||Number
1417824|NCT01118091|Secondary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 years||||Participants|||Number
1417825|NCT01118091|Primary|Response Rate|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 years||||Participants|||Number
1417826|NCT01118052|Secondary|Progression-free Survival|The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.|The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years|Eligible and treated patients|||months||90% Confidence Interval|Median
1417827|NCT01118052|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|The duration of time from start of treatment to time of death or the date of last contact, assessed up to 5 years|Eligible and treated patients|||months||90% Confidence Interval|Median
1417828|NCT01118052|Primary|Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0|Adverse events are listed by adverse event and grade. The number of participants affected is listed.|All Adverse Events (AEs) deemed at least possibly related to study treatmetn occurring during treatment and up to 30 days after stopping the study treatment. for up to 5 years after stopping study treatment|Eligible and evaluable patients|||Participants|||Count of Participants
1417829|NCT01118052|Primary|Patients Who Have Objective Tumor Response (Complete or Partial Response)|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|CT or MRI used to follow lesion for measurable disease every other cycle. Patient's best response while on study treatment was recorded, Up to 5 years|Eligible and Treated patients|||percentage of participants||90% Confidence Interval|Number
1417830|NCT01118052|Primary|Patients Who Survive Progression-free for at Least 6 Months|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression|Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years|Eligible and treated patients|||Participants|||Count of Participants
1417831|NCT01118013|Secondary|Rate of Opportunistic Infections|Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.|1 year post transplant|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
1417832|NCT01118013|Secondary|Overall Survival|Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.|Up to 5.5 years|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
1417833|NCT01118013|Secondary|Complete Response Rate|Complete response (CR) rate is reported as the percentage of participants who achieved a CR.|Up to 5.5 years|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
1417834|NCT01118013|Primary|Comparison of EFS Distribution to That of CALGB-100002|EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.|2 years|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
1423524|NCT01069341|Secondary|Mean Number of Ranibizumab Injections|Mean number of ranibizumab injections required through month 12|first 12 months|All subjects' data was analyzed, no subjects were excluded|||Number injections||Standard Deviation|Mean
1417835|NCT01118013|Primary|Event-free Survival (EFS)|EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.|Duration of study (up to 5.5 years)|Due to study termination, data were not collected and the outcome measure was not analyzed.||||||
1417836|NCT01117987|Secondary|Percentage of Participants With Incidence of Clinical Worsening Events|Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.|204 weeks|Full Analysis Set (FAS): The full analysis set included all participants who received at least one dose of study drug during the extension.|||Percentage of participants|||Number
1417837|NCT01117987|Secondary|Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)|A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).|core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks|Participants from the Full Analysis Set (FAS), who had values at both core study baseline and the given post-baseline time point, were included in the analysis for that post-baseline time point. The FAS included all participants who received at least one dose of study drug during the extension.|||meters||Standard Deviation|Mean
1417838|NCT01117987|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|204 weeks|Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.|||Participants|||Number
1417839|NCT01117948|Secondary|Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI||6 months double-blind, 6 months open label (optional)|||||||
1417840|NCT01117948|Primary|Cognitive Performance - ADAS-cog+|"Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items).~Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind)."|6 months double blind, 6 months open-label (optional)||||units on a scale||Standard Deviation|Mean
1417841|NCT01117870|Secondary|Number of Participants Who Discontinued Analgesics After Intervention|Number of PRF treatment patients with increase or decrease in medication use (either in dose, frequency, or no use), compared with the placebo group.|4 weeks|Number of participants who discontinued analgesics after intervention|||Participants|||Count of Participants
1417842|NCT01117870|Secondary|Change in Oswestry Disability Index (ODI) From Baseline to 4 Week|ODI is an index derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to: care for oneself, walk, sit, sexual function, stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|baseline (at recruitment) and at 4 weeks|Success defined as at least 50% improvement in Oswestry Disability Index (ODI) - measured at 4 weeks compared to placebo group.|||percentage change of ODI||Standard Deviation|Mean
1417843|NCT01117870|Secondary|Assessment of Side Effects|Percentage of patients having side effects after PRF treatment assessed at 1 week compared to placebo group. Assessment of persisting side effects, percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment|1 week and up to 3 months|Assessment of persisting side effects and percentage of patients having side effects after PRF treatment beyond 1 week compared to the placebo group. Side effects could be nausea, headache, momentary increase in pain, fever, tingling, itching, and/or burning skin at point of treatment|||percentage of participants|||Number
1417844|NCT01117870|Secondary|Change in Mean Visual Analogue Scale (VAS) Scores From Baseline to 4 Weeks|"Secondary outcomes were considered as exploratory. Is PRF an effective treatment for patients with CLR pain? It will be measured by a change in VAS scores from baseline measurement at recruitment.~Visual analog scale (VAS) - For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 10) on a 10-cm scale."|baseline (at recruitment) and at 4 Weeks|Intent to treat analysis was used.|||units on a scale||Standard Deviation|Mean
1417845|NCT01117870|Primary|Number of Participants Lost to Follow-up at 3 Months|Patients who were lost to follow-up at 3 months were recorded.|3 months||||Participants|||Count of Participants
1417846|NCT01117870|Primary|Recruitment Rate|Expected recruitment is at least 4 patients per month. At least 80% of eligible patients fulfilling the selection criteria can be recruited. The final assessment was at the end of 15 months, at which time all the subjects were enrolled. Participants withdrawing within 4 weeks after the interventional shall not be included in the study. However participants withdrawing after 4 weeks of the intervention shall be included in the final analysis, on intention to treat principle.|15 month point|Patients with suspected leg pain were initially approached by the research assistant. Further screening for eligibility was done in the presence of the physician. Suitable patients met with the research assistant (blind to intervention), who noted down the baseline parameters of the patient after obtaining an informed consent.|||Participants|||Count of Participants
1417905|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Extension Period|Value at the end of the extension period defined as last available HbA1c value measured during the extension period (i.e. last observation carried forward (LOCF) value)|week 36, week 48|The population analyzed for this outcome measure consisted of the mITT patients who had at least one HbA1c value on treatment during the extension period.|||percentage of participants|||Number
1417847|NCT01117857|Other Pre-specified|Change in Overall Well Being Measured by the Clinical Global Impression Scale (CGI)|The CGI is a scale to measure the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Severity is ranked 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
1417848|NCT01117857|Other Pre-specified|Change in Hot Flash Interference With Daily Activities and Quality of Life as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)|The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
1417849|NCT01117857|Other Pre-specified|Change in Anxiety as Measured by the Generalized Anxiety Disorder Questionnaire (GAD-7)|The GAD-7 is a valid and efficient tool for screening anxiety and assessing its severity in clinical practice and research. Subjects rate the items for severity on a 4-point scale from 0 (not at all) to 3 (nearly every day) for a total range of 0-21. A higher score indicates greater anxiety symptom burden.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
1417850|NCT01117857|Secondary|Change in Menopause Symptoms as Measured by the Greene Climacteric Scale|The Greene Climacteric Scale (GCS) is a 21-item scale used to quantify the severity of perimenopausal somatic symptoms. Each item is scored 0-3 for a total range of 0-63, with a higher score indicating greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
1417851|NCT01117857|Primary|Change in Depression Scores as Measured by the Hamilton Rating Scale for Depression|The HAM-D is a 17-item well-validated and reliable measure of current depressive symptoms and their severity. Eight items are scored on a five-point scale (0-4), and nine are scored on a three-point scale (0-2) for a total score range of 0-50. A higher score indicates greater symptom severity.|Baseline to week 9|Of the 19 participants who received study medication, 16 were considered evaluable for the purpose of analyses as they returned for at least one assessment after starting the study intervention.|||units on a scale||Inter-Quartile Range|Median
1417852|NCT01117766|Secondary|Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7|NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.|Week 4 (Visits 4 and 7) of each period|FAS. n=18, 18; number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
1417853|NCT01117766|Secondary|Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7|Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to “How intense is your pain today?”|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
1417854|NCT01117766|Secondary|Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7|PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
1417855|NCT01117766|Secondary|Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7|Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing weeks within a period were imputed using last observation carried forward (LOCF).|||scores on a scale||Standard Deviation|Mean
1417856|NCT01117766|Primary|Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.|||scores on a scale||Standard Deviation|Mean
1417857|NCT01117766|Primary|Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7|Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.|||scores on a scale||Standard Deviation|Mean
1417858|NCT01117766|Primary|Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||cm2||Standard Deviation|Mean
1417859|NCT01117766|Primary|Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7|Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean. Missing values were imputed using a single imputation regression method.|||scores on a scale||Standard Deviation|Mean
1417860|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7|Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|FAS. n=number of participants contributing to the mean.|||cm2||Standard Deviation|Mean
1417861|NCT01117766|Primary|Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7|Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a “strange” or “tickly” sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.|Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period|Full analysis set (FAS)=participants with present pain intensity score >=4 out of 10 for brush evoked allodynia at screening and randomization, >=4 out of 7 non missing values in week prior to randomization, >4 for weekly average daily pain score, and who did not withdraw/discontinue. n=number of participants contributing to the mean.|||scores on a scale||Standard Deviation|Mean
1417862|NCT01117727|Primary|Accuracy of Using the BCI as a Switch to Select From 4 Targets Using Scanning|Average accuracy for selecting one of 4 targets with a switch operated by a brain-computer interface controlled by power in the sensorimotor rhythms. The 8 sessions were conducted over a 2 month period. Accuracy was calculated as the percentage of trials in which the target was correctly selected. Trials for all sessions were combined to create the overall average. Therefore, there is no standard deviation. .|8 sessions over 2 months||||percent of correct targets selected|||Number
1417863|NCT01117623|Other Pre-specified|Tumor Response in Expansion Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only|||Participants|||Number
1417864|NCT01117623|Other Pre-specified|Tumor Response in Dose Escalation Cohort|Tumor Response (= Best Overall Response) of a participant was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set)|||Participants|||Number
1417865|NCT01117623|Other Pre-specified|Tumor Progression in Expansion Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|ITT efficacy analysis (set), expansion cohorts only|||Participants|||Number
1417963|NCT01116882|Primary|30-day Composite Major Adverse Cardiac Event (MACE)||30 days|The denominator for MACE at 30 days is defined as patients who either had MACE to 30d or had follow up of at least 23 days.|||participants|||Number
1417866|NCT01117623|Other Pre-specified|Tumor Progression in Dose Escalation Cohort|Tumor progression evaluates changes in a tumor or tumors over time due to worsening of disease. Measurements and observations of the tumor status were performed before, during and after treatment. Progression for solid tumors was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) criteria. Tumor dimensions were measured in millimeters and the longest diameter (LD) was recorded for up to 5 lesions per organ and 10 lesions total. A sum of the LD for all target lesions was recorded. The use of a 20% increase in the sum of LD of target lesions from the smallest sum or appearance of a new lesion was assessed as progression of disease.|From the screening visit of the first participant until the last evaluation of the final participant over 6 years later, assessed at the screening visit, end of cycle 2, end of each even cycle and during the final visit (end of treatment)|Intent-to-treat (ITT) efficacy analysis (set)|||Participants|||Number
1417867|NCT01117623|Secondary|Biomarker Soluble Vascular Endothelial Growth Factor Receptor 2 (sCEGFR-2) Plasma Levels|The analysis of Biomarker sCEGFR-2 plasma levels is not done.|No data obtained|ITT||||||
1417868|NCT01117623|Secondary|Biomarker Vascular Endothelial Growth Factor (VEGF) Plasma Levels|The analysis of Biomarker VEGF plasma levels is not done|No data obtained|ITT||||||
1417869|NCT01117623|Secondary|Ratio of AUCt,ss/AUC (RLIN)|RLIN is the ratio of the measure of systemic drug exposure at steady state to the measure of systemic drug exposure after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|PK population; Number of Participants with an evaluable AUCt,ss and AUC in at least one analyte were 0 in 20mg; 3 (regorafenib) and 4 (M2) in 40mg; 3 in 100 mg; 2 (regorafenib) and 0 (M2) in 120 mg; 3 (regorafenib) and 2 (M2) in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 4 in NSCLC; No participants have evaluable data for M5.|||Ratio|||Number
1417870|NCT01117623|Secondary|Ratio of AUCt,ss/AUCt (RAAUC)|RAAUC is the ratio of the measure of systemic drug exposure over a specific dosing interval at steady state to the measure of systemic drug exposure over a specific dosing interval after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUCt,ss and AUCt in at least one analyte were 0 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||Ratio|||Number
1417871|NCT01117623|Secondary|Ratio of Cmin,ss/Cmin (RACmin)|RACmin is the ratio of the lowest drug concentration at steady state to the lowest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmin,ss and Cmin in at least one analyte were 0 (M5) in 20mg; 6 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||Ratio|||Number
1417872|NCT01117623|Secondary|Ratio of Cmax,ss/Cmax (RACmax)|RACmax is the ratio of the highest drug concentration at steady state to the highest drug concentration after single dose administration. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1 and Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss and Cmax in at least one analyte were 1 (M5) in 20mg; 5 (regorafenib and M2) and 4 (M5) in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||Ratio|||Number
1417873|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss)|Tmax,ss refers to the time after multiple dose administration and after a steady state concentration has been reached when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Tmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||h||Full Range|Median
1417874|NCT01117623|Secondary|AUC From Time 0 to 24 Hours at Steady State Divided by Dose (AUC(0-24)ss/D)|AUC(0-24)ss/D is a measure of systemic drug exposure (AUC) over 24 hours after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24)ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||h/L||Geometric Coefficient of Variation|Geometric Mean
1417875|NCT01117623|Secondary|Cmax at Steady State During a Dosing Interval Divided by Dose (Cmax,ss/D)|Cmax,ss/D refers to the highest measured drug concentration after multiple dose administration and after a steady state concentration has been reached, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss/D in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||1/L||Geometric Coefficient of Variation|Geometric Mean
1424574|NCT01059760|Primary|Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed||Baseline and 3 days||||cells x 10^6/mL||Standard Deviation|Mean
1417876|NCT01117623|Secondary|Half-life Associated With the Terminal Slope (T1/2)|T1/2 is the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|PK population; Number of Patients with at least an evaluable T1/2 were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (regorafenib and M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10(M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC|||h||Geometric Coefficient of Variation|Geometric Mean
1417877|NCT01117623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Tmax in at least one analyte were 1 (M-5) in 20 mg; 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M-5) in NSCLC|||h||Full Range|Median
1417878|NCT01117623|Secondary|Maximum Observed Plasma Concentration After Single Dose Administration Divided by Dose (Cmax/D)|Cmax/D refers to the highest measured drug concentration after a single dose administration, which is then divided by the administered dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax/D in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC|||1/L||Geometric Coefficient of Variation|Geometric Mean
1417879|NCT01117623|Secondary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose Divided by Dose (AUC/D)|The AUC/D is a measure of systemic drug exposure (AUC) after the first single dose, which is then divided by that dose. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC/D were 5 (regorafenib) and 6 (M-2) in 40mg; 5 (regorafenib and M-2) in 100 mg; 3 (M-2) in 120 mg; 6 (regorafenib and M-2) in 140 mg; 9 (regorafenib), 10 (M-2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M-2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M-2) in NSCLC|||h/L||Geometric Coefficient of Variation|Geometric Mean
1417880|NCT01117623|Secondary|AUC From Time 0 to the Last Data Point > Lower Limit of Quantification (LLOQ) (AUC(0-tlast))|The AUC(0-tlast) is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-tlast) in at least one analyte were 1(M-5) in 20mg; 7 (regorafenib and M-2) and 5 (M-5) in 40mg; 13 (M-5) in HCC Child Pugh A; 22 (M5) in NSCLC|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1417881|NCT01117623|Primary|AUC From Time 0 to 24 Hours at Steady State(AUC(0-24),ss)|AUC(0-24),ss is a measure of systemic drug exposure over 24 hours, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable AUC(0-24),ss in at least one analyte in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1417882|NCT01117623|Primary|Cmax at Steady State During a Dosing Interval (Cmax,ss)|Cmax,ss refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample, after multiple dose administration and after a steady state concentration has been reached.|Blood samples were collected at on Cycle 2, Day 1 and on Cycle 3, Day 1 for expansion cohort. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10 and 24h post-dose.|Pharmacokinetic population; Number of Participants with an evaluable Cmax,ss in at least one analyte were 6 in 40mg; 6 in 100 mg; 2 in 120 mg; 3 in 140 mg; 0 in HCC Child Pugh A; 1 in HCC Child Pugh B; 5 in NSCLC|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1417883|NCT01117623|Primary|Area Under the Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose (AUC)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|PK population; Number of Participants with at least one evaluable AUC were 5 (regorafenib) and 6 (M2) in 40mg; 5 (regorafenib and M2) in 100 mg; 3 (M2) in 120 mg; 6 (regorafenib and M2) in 140 mg; 9 (regorafenib), 10 (M2) and 1 (M5) in HCC Child Pugh A; 3 (regorafenib) and 2 (M2) in HCC Child Pugh B; 19 (regorafenib) and 16 (M2) in NSCLC|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
1417884|NCT01117623|Primary|Maximum Observed Plasma Concentration After Single Dose Administration (Cmax)|Cmax refers to the highest measured drug concentration, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Blood samples were collected on Cycle 1, Day 1. Samples were drawn at the following time points: 0 h pre-dose, 0.5, 1, 2, 4, 8, 10, 24, and 48 h post-dose|Pharmacokinetic population; Number of Participants with an evaluable Cmax in at least one analyte was 1 (M5) in 20mg; 7 (regorafenib and M2) and 5 (M5) in 40mg; 13 (M5) in HCC Child-Pugh A; 22 (M5) in NSCLC|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1419841|NCT01099761|Secondary|Change in Pulmonary Function Test (MIP)|Maximum Inspiratory Pressure (MIP); 2 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit. approximately 24 weeks||||cm H2O||Standard Deviation|Mean
1417886|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)|The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 3 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI.|||units on a scale||Standard Deviation|Mean
1417887|NCT01117480|Secondary|Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ.|||units on a scale||Standard Deviation|Mean
1417888|NCT01117480|Primary|Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject’s Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Month 0, 6, 12, 18 and 24|Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28.|||percentage of participants|||Number
1417889|NCT01117454|Primary|Number of Patients With Ventricular Ectopy or VT During Exercise Treadmill Testing|Hypothesis: the addition of oral flecainide to standard therapy will reduce ventricular ectopy and/or VT on treadmill exercise treadmill testing in patients with CPVT, compared to placebo plus standard therapy.|3 months|1 participant did not complete treadmill test|||Participants|||Count of Participants
1417890|NCT01117428|Secondary|Terminal Half-Life (T½)|"For Part A, the endpoint was not calculated. For Parts B, C and F, the endpoint was calculated for each patient following the first and fourth Sym004 infusions.~For Parts D and E, the endpoint was calculated for each patient following the first and third Sym004 infusions.~T½ was estimated using non-compartmental methods and actual time points.~Outcome Measure Time Frame:~Parts B, C and F (Weekly dosing): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) until 1 week post-infusion (168-hours) and at Visit 5 (4th dose from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 1 week post-infusion (168-hours).~Parts D, E (Dosing every second week): Sample collection at Visit 2 (1st dose from end of infusion, 1-, 2-, 4-, 8-, 24-, 48-hours) to end of 3rd dose (from end of infusion, 1-, 2-, 4-, 8-, 24-hours) until 2 weeks post-infusion (336 hours)."|See Time Frame in the Outcome Measure Description|For Part A, data could not be reported as the endpoint was not calculated and no pharmacokinetics (PK) analysis set was defined. For Parts B to F, a PK analysis set was used.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1417891|NCT01117428|Secondary|Antitumor Activity Endpoints - Time-to-event Endpoints|"Median Progression Free Survival (PFS) was defined as the time interval without PD from start of first infusion until death or documented PD (i.e. at least a 20% increase in the sum of diameters of target lesions) according to RECIST v1.1. Patients who died without confirmed PD were considered as progressed. Patients who died or showed PD more than 21 days after last treatment were censored (i.e. were considered alive without progression on Day 21 after last treatment). Patients without events were censored at date of last scan or 22 days after last treatment, whichever occurred first.~Median Overall Survival (OS) was defined as the time from start of first infusion until date of death from any cause. Patients alive at the time of the analysis or prematurely withdrawn from the trial (e.g. lost to follow-up or consent withdrawn) were censored for the OS analysis. In any case of censoring, the date of censoring was the last time point documenting survival status."|Up to 62 weeks||||Months||95% Confidence Interval|Median
1417892|NCT01117428|Secondary|Antitumor Activity|Best Overall Response (OR) on the Full Analysis Set (FAS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, based on central evaluation with confirmatory CT scan or MRI [Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR): CR + PR]. Baseline was defined as Visit 2 (pre-infusion). The outcome measure was measured from screening until PD.|Up to 62 weeks|Data for Part A were presented only for the FAS. For Parts B to F, analyses and summaries were performed both for the FAS and for the per protocol population. The FAS was considered the primary analysis population.|||percentage of participants||95% Confidence Interval|Number
1417893|NCT01117428|Primary|Number of Participants With Adverse Events (AEs)|The AEs were used as a primary endpoint. AEs were summarized using descriptive statistics and presented overall by system organ class and preferred term. The frequencies of AEs were presented including number and percentages of participants with events and the total number of events.|Visit 2 until first follow-up visit (up to 66 weeks)||||Participants|||Count of Participants
1417964|NCT01116687|Secondary|Number of Related Serious Adverse Events (SAEs)|Study drug related grade 3-4 toxicities. To measure Adverse Events, investigators used the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Study duration of 12 months|All evaluable participants|||events|||Number
1417894|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Extension Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.~Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:~The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),~Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the extension period (from week 24 to week 48)|The population analyzed was the safety population (extension) i.e. all treated patients during the extension period.|||participants|||Number
1417895|NCT01117350|Secondary|Hypoglycemia Occurence: Number of Patients With at Least One Episode of Symptomatic / Severe Symptomatic Hypoglycemia During the Comparative Period|"Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia.~Severe symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia, requiring the assistance of another person for active administration of carbohydrate, glucagon or other countermeasure because the patient could not treat him/herself due to acute neurological impairment directly resulting from the hypoglycemia (assistance by another person when the patient could have treated him/herself was not considered as requiring assistance)and one of the following criteria:~The event was associated with a measured PG level < 36 mg/dL (2 mmol/L),~Or, in absence of PG value, the event was associated with neurological recovery attributable to the restoration of PG to normal, after oral carbohydrate, intravenous glucose or glucagon administration."|all across the comparative period (from week 0 to week 24)|The population analyzed was the safety population i.e. all randomized and treated patients.|||participants|||Number
1417896|NCT01117350|Secondary|Daily Dose of Insulin Glargine Administered During the Extension Period||week 30, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this mITT population were analyzed at each week.|||Unit (U)||Standard Deviation|Mean
1417897|NCT01117350|Secondary|Daily Dose of Liraglutide||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.|||mg||Standard Deviation|Mean
1417898|NCT01117350|Secondary|Daily Dose of Insulin Glargine||week 1, week 2, week 6, week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed at each week.|||Unit (U)||Standard Deviation|Mean
1417899|NCT01117350|Secondary|Body Weight: Change From Beginning to End of the Extension Period|Change = Last weight value measured during the extension period (LOCF value) - weight value at beginning of the Extension Period (Week 24)|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the mITT population (extension).|||kg||Standard Deviation|Mean
1417900|NCT01117350|Secondary|Body Weight: Change From Baseline to the End of the Comparative Period|Change = Last weight value measured during the comparative period (LOCF value) - weight value at baseline|baseline (week 0), week 2, week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one weight value on treatment during the comparative period.|||kg||Standard Deviation|Mean
1417901|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Beginning to the End of the Extension Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value"|week 24, week 36, week 48|The population considered was the mITT population (extension) but due to missing values, different subsets of this population were analyzed for each time point of the profile.|||mg/dL||Standard Deviation|Mean
1417902|NCT01117350|Secondary|Self-Monitored 7-point Plasma Glucose (PG) Profile: Change From Baseline to the End of the Comparative Period|"Self-monitored 7-point plasma glucose profiles (before and 2 hours after the start of breakfast, lunch and dinner, and at bedtime) recorded on 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value"|baseline (week 0), week 12, week 24|The population considered was the mITT population but due to missing values, different subsets of this mITT population were analyzed for each time point of the profile.|||mg/dL||Standard Deviation|Mean
1417903|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Beginning to the End of the Extension Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the extension period defined as last available value during the extension period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - week 24 value"|week 24, week 30, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT (extension) patients who had SMFPG value both at beginning of the extension and at least one value on treatment during the extension period.|||mg/dL||Standard Deviation|Mean
1417904|NCT01117350|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Measurements: Change From Baseline to the End of the Comparative Period|"SMFPG = mean value of Self-Monitored Fasting Plasma Glucose measurements over 3 consecutive days in the week before each visit~Value at the end of the comparative period defined as last available value during the comparative period (i.e. last-observation-carried-forward [LOCF] value)~Change = LOCF value - baseline value"|baseline (week 0), week 6, week 12, week 18, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one SMFPG value on treatment during the comparative period.|||mg/dL||Standard Deviation|Mean
1418439|NCT01113398|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|2 years|Intent-to-treat|||Months||95% Confidence Interval|Median
1417906|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Beginning to the End of the Extension Period|Change in HbA1C from beginning of the extension period (week 24) to the last observation carried forward (LOCF) measured during the extension period = LOCF value - week 24 value|week 24, week 36, week 48|The population analyzed for this outcome measure consisted of the subset of mITT population (extension) who had HbA1c value both at beginning of the extension and at least one value on treatment during the extension period.|||percent||Standard Deviation|Mean
1417907|NCT01117350|Secondary|Glycosylated Haemoglobin (HbA1c): Change From Baseline to the End of Comparative Period|Change in HbA1C from baseline to the last observation carried forward (LOCF) measured during the comparative period = LOCF value - baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percent||Standard Deviation|Mean
1417908|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Increased at the End of the Comparative Period|Percentage of patients with HbA1c value at end of the comparative period (LOCF) higher than HbA1c baseline value|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percentage of participants|||Number
1417909|NCT01117350|Secondary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) Has Decreased But Remains ≥7% at the End of the Comparative Period|"Percentage of patients with:~* HbA1c value at end of the comparative period (LOCF) lower than HbA1c baseline value~AND~* HbA1c value at end of the comparative period (LOCF) ≥7%"|baseline (week -2), week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percentage of participants|||Number
1417910|NCT01117350|Primary|Percentage of Patients Whose Glycosylated Haemoglobin (HbA1c) <7% at the End of the Comparative Period|The value at the end of the comparative period was defined as the last available HbA1c value measured during the comparative period plus 14 days after the last dose of Investigational Product (i.e. last-observation-carried-forward [LOCF] value).|week 12, week 24|The population analyzed for this outcome measure consisted of the subset of mITT patients who had at least one HbA1c value on treatment during the comparative period.|||percentage of participants|||Number
1417911|NCT01117337|Secondary|Seroma Formation|A seroma was defined as a non tender, irreducible hemispherical swelling with a fluctuant or firm consistency at the hernia site, examined and found during the first year. The diagnosis was based on the clinical finding of a palpable fluid collection without a size limit. One could get above the upper border of the swelling and there was usually absence of a cough impulse. To detect seroma, the clinical examination was carried at the first follow-up visit on the 7th postoperative day.|One year||||Participant|||Number
1417912|NCT01117337|Primary|Proportion of Patients Having Pain in the Post Operative Period|To compare the proportion of patients having pain in the mesh fixation and non fixation group at one month postoperatively.|1 month||||Participant|||Number
1417913|NCT01117337|Primary|Recurrence of Inguinal Hernia on the Operated Side in Mesh Non-fixation and Mesh Fixation Group.|Patients in both the arms will be followed up post operatively at 24 hours, 1 week, 1 month and 1 year to check for recurrence or persistence of inguinal hernia on the operated side. At these follow up visits, the patients would be asked about reoccurence of bulge on the operated side and will be examined clinically. In case, there is a suspicion of recurrence, the patient would be examined by a second surgeon and undergo Ultrasound and/or CT to confirm the recurrence of hernia.|1 year||||Participant|||Number
1417914|NCT01117311|Secondary|Gastric Emptying Half-time|Gastric emptying half time is the time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested||||minutes||Standard Error|Mean
1417915|NCT01117311|Primary|Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|baseline, 2 weeks||||10^-14dl/kg/min^2 per pmol/l||Standard Error|Mean
1417916|NCT01117181|Secondary|Electrocardiogram (ECG)|Abnormal electrocardiogram results at 6 weeks|6 weeks||||participants with abnormal ECG|||Number
1417917|NCT01117181|Secondary|Electrolytes|Percent of participants with abnormal electrolyte values at 6 weeks as assessed by local laboratory|6 weeks|One patient in the active group completed all visit 6 assessments except for the blood collection for the electrolyte sample. This patient refused this procedure.|||percentage of participants|||Number
1417918|NCT01117181|Secondary|Vital Status|vital status as measured by death|vital status at 6 weeks||||participants who died|||Number
1417919|NCT01117181|Secondary|Neuropsychiatric Inventory (NPI): Apathy Subscale|Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance.|baseline to week 6||||units on a scale||Standard Error|Mean
1417920|NCT01117181|Secondary|Mini-Mental State Exam (MMSE)|Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment.|baseline and 6 weeks||||units on a scale||Standard Error|Mean
1417921|NCT01117181|Secondary|Digit Span|Change in Digit Span from baseline to 6 weeks. The Wechsler Adult Intelligence Scale – Revised Digit Span is used to assess auditory attention and working memory. Both forward and backward span is assessed. Both tests consist of six number sequences that the psychometrist reads aloud one at a time. After each sequence is read, the participant must repeat the digits back in the same (forward) or reverse (backward) order. Scores range from 0 to 16, with higher numbers indicate better functioning.|baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
1424575|NCT01059760|Primary|Change From Baseline in Participant Hemoglobin When Fasting and Fed||Baseline and 3 days||||g/dL||Standard Deviation|Mean
1417922|NCT01117181|Primary|Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change|"Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: marked worsening(7), moderate worsening (6), minimal worsening(5), no change(4), minimal improvement(3), moderate improvement(2), marked improvement(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement."|baseline to 6 weeks||||percentage of participants who improve|||Number
1417923|NCT01117181|Primary|Apathy Evaluation Scale (AES)|Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.|baseline to 6 weeks||||units on a scale||Standard Error|Mean
1417924|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a valsalva maneuver|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the subject was unable to perform the valsalva, or if data were missing.|||mmHg||Standard Deviation|Mean
1417925|NCT01117090|Secondary|The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, the mean change in CSF pressure data during the physical task of a cough|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, or if the subject was unable to cough.|||mmHg||Standard Deviation|Mean
1417926|NCT01117090|Secondary|The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis|Characterize the relationship between pressure decay-to-baseline time (in seconds) and the physician's standard trouble-shooting diagnosis|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, if there was an issue with the equipment, if the clamp was not open, or if the resistance check data were missing.|||seconds||Standard Deviation|Mean
1417927|NCT01117090|Primary|Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis|Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, CSF signatures recorded in subjects who have an infusion system who present with signs and/or symptoms of possible catheter-related problems or failure.|1 day|Subjects were excluded if the needle was not in the CAP, if they had a ventricular catheter, if the pressure sensor malfunctioned, or if there was an issue with the equipment|||Subjects whose CSF data agree with MD Dx|||Number
1417928|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 8||Week 8|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)|||ng/ml||Standard Deviation|Mean
1417929|NCT01117051|Secondary|Plasma Concentration of Prucalopride at Week 2||Week 2|ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation)|||ng/ml||Standard Deviation|Mean
1417930|NCT01117051|Primary|Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week|A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.|12 weeks|Intent-to-Treat (ITT) population includes all subjects who were randomized into the study and who had received at least 1 dose of investigational medication.|||percentage of subjects|||Number
1417931|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Weight Through Week 96|Weight is a measurement of nutritional status. Absolute change in weight, measured in kilograms (kg), at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.|||kg||Standard Deviation|Mean
1417932|NCT01117012|Secondary|Annualized Duration of Pulmonary Exacerbation Events||Study 105: Day 1 through Week 96|Full Analysis Set.|||Days per year||Standard Deviation|Mean
1417933|NCT01117012|Secondary|Annualized Pulmonary Exacerbation Event Rate|Annualized event rate was calculated by regression with negative binomial distribution.|Study 105: Day 1 through Week 96|Full Analysis Set.|||events per year|||Number
1417934|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1417935|NCT01117012|Secondary|Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in Study 105. Absolute Change at Week 48 and Week 96 are reported.|Study 105: Baseline through Week 96|Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.|||percent predicted of FEV1||Standard Deviation|Mean
1418023|NCT01115933|Secondary|Acute Stent Thrombosis|Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|<24 hours|FAS population|||percentage of participants|||Number
1417936|NCT01117012|Secondary|Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as Study 105 Day 15.|Study 105: Baseline through Week 96|Full Analysis Set.|||percent predicted of FEV1 per year||95% Confidence Interval|Least Squares Mean
1417937|NCT01117012|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.|Study 105: Day 1 up to Week 168|Safety Set included all participants who received at least 1 dose of study drug during Study 105.|||participants|||Number
1417938|NCT01116986|Primary|Self-Reported 7-Day Point-Prevalence Abstinence|"Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model.~Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal Addiction) advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome."|16 weeks post-quit||||participants|||Number
1417939|NCT01116986|Secondary|Latency to Relapse|Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.|During the first 6 months post-quit||||participants|||Number
1417940|NCT01116934|Primary|Serum Concentrations of Interleukin (IL)-1 Beta|Concentrations of IL-8, IL-6, IP-10, interferon (IFN)-gamma, and IL-1 beta, in plasma/RPMI samples were determined by enzyme linked immunosorbent assay (ELISA) according to the manufacturers’ instructions|2006|Samples were stimulated with 100 ng/ml lipopolysaccharide (LPS)|||pg/ml||Inter-Quartile Range|Median
1417941|NCT01116921|Secondary|Incidence of Chronic Lung Disease||Measured at hospital discharge||||Participants|||Count of Participants
1417942|NCT01116921|Secondary|Incidence of Severe IVH or PVL||During hospitalization||||Participants|||Count of Participants
1417943|NCT01116921|Secondary|Incidence of Pulmonary Airleaks||First 7 days of life||||Participants|||Count of Participants
1417944|NCT01116921|Secondary|Duration of Oxygen Therapy||During first seven days of life||||hours||Standard Deviation|Mean
1417945|NCT01116921|Secondary|Duration of CPAP Therapy||During first seven days of life||||hours||Standard Deviation|Mean
1417946|NCT01116921|Primary|Need for Intubation and Mechanical Ventilation in the First Seven Days of Life.|“Treatment Failure” criteria were the same for both groups. “Treatment Failure” required two of the following: 1) FiO2 >40% for longer than 30 minutes (to maintain SaO2 88-92%), 2) PCO2 >65mmHg on ABG/CBG or >70 on VBG, or 3) pH<7.22 on ABG/CBG/VBG or one of the following: 1) recurrent or severe apnea, 2) hemodynamic instability requiring pressors, 3) repeat surfactant dose at appropriate time with FiO2 >40%, or 4) deemed necessary by medical provider.|Seven days||||Participants|||Count of Participants
1417947|NCT01116882|Secondary|Any Repeat Revascularization||30 days|The denominator for any repeat revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.|||participants|||Number
1417948|NCT01116882|Secondary|Rate of Stent Thrombosis||30 days||||participants|||Number
1417949|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||12 months||||participants|||Number
1417950|NCT01116882|Secondary|Ischemia-driven Target Vessel Revascularization||30 days||||participants|||Number
1417951|NCT01116882|Secondary|All Cause Mortality at 12 Months||12 months||||participants|||Number
1417952|NCT01116882|Secondary|Met Indication Criteria for PCI|Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions.|Post-Procedure||||lesions|Participants||Number
1417953|NCT01116882|Secondary|Complete Revascularization|Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis.|Post-Procedure||||participants|||Number
1417954|NCT01116882|Secondary|Major Vascular Complications||30 days||||participants|||Number
1417955|NCT01116882|Secondary|Procedural Success|Procedural success is defined as residual stenosis of the target lesion of less than 20%|Post-Procedure||||participants|||Number
1417956|NCT01116882|Secondary|Emergency or Urgent Revascularization||30 days|The denominator for emergency or urgent revascularization at 30 days is defined as patients who either had the event to 30d or had follow up of at least 23 days.|||participants|||Number
1417957|NCT01116882|Secondary|Any Repeat Revascularization||12 months||||participants|||Number
1417958|NCT01116882|Secondary|Rate of Stent Thrombosis||12 months||||participants|||Number
1417959|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||12 months||||participants|||Number
1417960|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||30 days||||participants|||Number
1417961|NCT01116882|Secondary|All Cause Mortality at 30 Days||30 days|The denominator for MACE at 30 days is defined as patients who either died to 30d or had follow up of at least 23 days.|||participants|||Number
1417962|NCT01116882|Primary|12-month Composite Major Adverse Cardiac Event (MACE)||12 month||||participants|||Number
1418024|NCT01115933|Secondary|All Coronary Revascularization||9 months|FAS population|||percentage of participants|||Number
1417965|NCT01116687|Secondary|Participant Progression Free Survival (PFS) Rate|Progression-Free Survival defined as the time from start of treatment until disease progression or death as a result of any cause. Patients were re-evaluated for response every 8 weeks. Response and progression were evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.|Study duration of 12 months|All evaluable participants|||months||95% Confidence Interval|Median
1417966|NCT01116687|Secondary|Participant Overall Survival (OS) Rate|Overall Survival defined as the time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive. The Kaplan-Meier method was used to estimate all time-to-event functions. Statistical analysis was performed using Stata SE 9.0 software and SAS 9.2 software.|Study duration of 12 months|All evaluable participants|||months||95% Confidence Interval|Median
1417967|NCT01116687|Primary|Number of Participants With Objective Radiographic Response (ORR)|To determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least 2 prior treatments in the metastatic setting. Radiologic assessment of tumor burden (CT scans of the chest, abdomen and pelvis, or MRI of the abdomen and pelvis and CT of the chest) was scheduled every 8 weeks. Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) were used for evaluation of the primary endpoint.|2 months from enrollment for each participant|All evaluable participants|||participants|||Number
1417968|NCT01116466|Secondary|Change in MRI of Affected Leg and Implant Post-implantation|MRI will be conducted to evaluate the impact of the implant on the common peroneal nerve (e.g. positioning of the nerve cuff along the nerve, path of the lead wire and the common peroneal nerve, estimation of the cross-sectional area of the common peroneal nerve compared to the pre-operative MRI recording, etc.)|Week 3 post-implantation|||||||
1417969|NCT01116466|Secondary|Nerve Conduction Velocity of the Peroneal Nerve|Measured: Nervus peroneus communis (CPN) and Nervus peroneus superficialis (SPN)|Baseline, week 12 post-implantation|Two subjects were unavailable for the test.|||m/s||Standard Deviation|Mean
1417970|NCT01116466|Secondary|Four Square Step Test (FSST)|It is a test of dynamic balance that clinically assesses the person's ability to step over objects forward, sideways, and backwards. The patient's time to perform the test is measured which shorter time representing better performance. At baseline this test was done with subject's conventional walking aid. At 12 weeks post-implantation it was done with and without stimulation.|Baseline, week 12 post-implantation||||s||Standard Deviation|Mean
1417971|NCT01116466|Secondary|Canadian Occupational Performance Measure (COPM) Score|A semi-structured interview is conducted in order to identify subject's limitations with daily occupations of importance in categories self-care, productivtiy or leisure. The subject is then asked to rate the imporance of each of the occupations using a 10-point rating scale. Afterwards the subject chooses up to 5 of the most important occupations (problems) (basis for identifying intervention goals). The subject is asked to use a 10 point scale to rate level of performance and satisfaction with performance for each of the five identified problems. Average COPM performance score and satisfaction score are calculated. The scores range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.|Baseline,12 weeks post-implantation|Two subjects were not available for the test.|||units on a scale||Standard Deviation|Mean
1417972|NCT01116466|Secondary|Walking Speed During 10 Meter Gait Test|The test assesses walking speed in meters per second over a short duration. At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation||||m/s||Standard Deviation|Mean
1417973|NCT01116466|Primary|Distance Walked in 6 Minutes|The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity (endurance). At baseline this test was done with subject's conventional walking aid. At 6 and 12 weeks post-implantation this was done with and without stimulation.|Baseline, 6 and 12 weeks post-implantation||||m||Standard Deviation|Mean
1417974|NCT01116427|Secondary|Mean Change in the MSFC in Extension Phase|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from Week 24 to Week 52 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week 24 to Week 52|Intent-to-treat in Extension Phase who Completed the MSFC at Week 52|||Scores on a scale||Standard Deviation|Mean
1417975|NCT01116427|Secondary|Annualized Relapse in Extension Phase|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the extension and follow-up phases in each treatment group by the total number of days participants participated in the study during the extension and follow-up phases. This number is then multiplied by 365.25 to get an annualized rate.|Week 24 to Week 64|Intent-to-treat in Extension Phase|||Relapse Rate by Year|||Number
1417976|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Extension baseline EDSS score was the most recent non-missing value on or before Week 28. Only participants who scored between a 0 and a 5 at baseline were analyzed for this outcome measure. EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week 24 to Week 64|Intent-to-treat in Extension Phase|||participants|||Number
1418025|NCT01115933|Secondary|All Coronary Revascularization||1 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1417977|NCT01116427|Secondary|Percent Brain Volume Change Between 24 Weeks and 52 Weeks|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week 24 and a MRI scan at Week 25 then the percent change from Week 24 to Week 52 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52 with data to contribute to brain volume measurements|||Percent change||Standard Deviation|Mean
1417978|NCT01116427|Secondary|Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks|Difference in total volume of all T2 lesions detected at Week 52 MRI scan compared to Week 24 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week 24 to Week 52|Intent-to-treat in Extension Phase who had an MRI at Week 52|||cm^3||Standard Deviation|Mean
1417979|NCT01116427|Secondary|Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase|The mean number of new inflammatory MRI lesions obtained on scans at Weeks 36 and 52, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week 24 MRI scan. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 36 and 52|Intent-to-treat in Extension Phase|||New Lesions||Standard Deviation|Mean
1417980|NCT01116427|Secondary|Mean Change in the MSFC Over 24 Weeks of Treatment|The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from baseline to Week 24 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.|Week -1 to Week 24|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
1417981|NCT01116427|Secondary|Annualized Relapse Rate|The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the core phase in each treatment group by the total number of days participants participated in the study during the core phase. This number is then multiplied by 365.25 to get an annualized rate.|Week -1 to Week 24|Intent-to-treat|||Relapse Rate by Year|||Number
1417982|NCT01116427|Secondary|Number of Participants Progressing on the EDSS Scale by at Least 1 Point|The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).|Week -1 to Week 24|Intent-to-treat|||participants|||Number
1417983|NCT01116427|Secondary|Mean Number of New Inflammatory Lesions in 8-week Intervals|The mean number of new inflammatory MRI lesions obtained on scans every 8 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Week 8 to Week 24|Intent-to-treat|||New Lesions||Standard Deviation|Mean
1417984|NCT01116427|Secondary|Percent Brain Volume Change|Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week -1 and a MRI scan at Week 24 then the percent change from Week -1 to Week 24 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24 and had MRI scans at both Week -1 and Week 24|||percent change||Standard Deviation|Mean
1417985|NCT01116427|Secondary|Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks|Difference in total volume of all T2 lesions detected at Week 24 MRI scan compared to Week -1 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.|Week -1 to Week 24|Intent-to-treat population that did not terminate study prior to Week 24|||cm^3||Standard Deviation|Mean
1417986|NCT01116427|Secondary|Absolute Number of New Inflammatory MRI Lesions on Monthly Scans|The absolute number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 4-24|Intent-to-treat|||New Lesions||Standard Deviation|Mean
1417987|NCT01116427|Primary|Mean Number of New Inflammatory MRI Lesions Per Monthly Scans|The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.|Weeks 8-24|Intent-to-treat|||New Lesions||Standard Deviation|Mean
1418026|NCT01115933|Secondary|Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|9 months|FAS population|||percentage of participants|||Number
1417988|NCT01116401|Secondary|Change in Montgomery-Asperg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score.|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1417989|NCT01116401|Primary|Percent Change in Wake After Sleep Onset (WASO)|Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.|baseline and 4 weeks||||percent change||95% Confidence Interval|Number
1417990|NCT01116232|Secondary|Immunocorrelative Studies Pre- and Periodically Post-transplantation||Using flow cytometry at 30, 60, 90, and 180 days post transplant.|||||||
1417991|NCT01116232|Secondary|Overall and Disease-free Survival||At 1 year|||||||
1417992|NCT01116232|Secondary|Incidence of Thrombotic Microangiopathy||Within 100 days of HCT|||||||
1417993|NCT01116232|Secondary|Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder||At one year|||||||
1417994|NCT01116232|Secondary|Incidence of Chronic GVHD||Within two years after transplant|||||||
1417995|NCT01116232|Primary|Safety Assessment||During the first six months post transplant|||||||
1417996|NCT01116232|Primary|Time to Engraftment||During the first six months post transplant|Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.||||||
1417997|NCT01116232|Primary|Incidence and Severity of Acute Graft-vs-host Disease (GVHD)||During the first six months post transplant|Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.||||||
1417998|NCT01116102|Secondary|Technical Challenges Encountered During Fluid Infusion|Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems|at any occurence of a defined challenge or at end of infusion if no challenges occurred|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)|||participants|||Number
1417999|NCT01116102|Secondary|Cumulative Fluid Volume Delivered||each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per Protocol (two subjects excluded due to technical errors in fluid pressure measurement)|||mL||Full Range|Mean
1418000|NCT01116102|Secondary|Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement||end of catheter/needle placement|Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurements)|||Subjects|||Number
1418001|NCT01116102|Primary|Maximum Measured In-line Fluid Pressure|Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion|each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion|Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)|||psi||Full Range|Mean
1418002|NCT01116037|Secondary|Safety Analysis Will be Based on the Occurence of Cardiovascular Complications.|Safety Analysis will be based on the the number of participants with cardiovascular complications.|Six Years||||participants|||Number
1418003|NCT01116037|Primary|Primary Efficacy Goal is to Assess the Freedom From Clinically Significant (Moderate or Greater) Aortic Regurgitation for the Patients Implanted With 3f Aortic Bioprothesis, Model 1000|Freedom from clinically significant (moderate or greater) aortic regurgitation will be determined through echocardiography and compared against the freedom from regurgitation event rates from the previous IDE study, G010284 used for PMA approval.|Six Years||||Participants|||Count of Participants
1418004|NCT01116024|Primary|Hemodynamics - Effective Orifice Area Index|The effective orifice area index is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve.|Five Years|At discharge Effective Orifice Area index data was collected for 61 subjects.|||EOAi (cm2/m2)||Standard Deviation|Mean
1418005|NCT01116024|Primary|Hemodynamics - Effective Orifice Area|"Effective orifice area (EOA) data.~The effective orifice area is a measure of how much the heart valve prosthesis impedes blood flow through the aortic valve."|Five Years|At discharge Effective Orifice Area data was collected for 61 subjects.|||EOA (cm2)||Standard Deviation|Mean
1418006|NCT01116024|Primary|Hemodynamic|Mean and peak pressure gradients from discharge through 5 years follow up. The gradient represents the difference in blood pressure across the valve.|Five Years|At discharge, gradient data was collected of 103 subjects.|||mmHg||Standard Deviation|Mean
1418007|NCT01116024|Primary|Effectiveness Endpoint - NYHA Classification, Hemodynamic Performance|"New York Heart Association (NYHA) classification to asses improvement of the cardiac status, Hemodynamic Performance analysis based on Doppler echocardiographic studies.~Class I: Patients with cardiac disease but without limitations of ordinary activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity results in fatigue, palpitations or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest. If any physical activity is undertaken discomfort is increased."|Five Years||||participants|||Number
1418008|NCT01116024|Primary|Re-operation, Explant, Repair|"Reoperation was defined in the protocol as any operation to repair, alter, or replace the study valve. Included is reoperation for repair of paravalvular leak and explant.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
1418027|NCT01115933|Secondary|Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418009|NCT01116024|Primary|Non-Structural Dysfunction|"Any abnormality resulting in stenosis or regurgitation at the operated valve that is not intrinsic to the valve itself. Non-structural dysfunction refers to non-structural problems that result in dysfunction of an operated valve exclusive of thrombosis and infection diagnosed by reoperation, autopsy, or clinical investigation.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
1418010|NCT01116024|Primary|Structural Valve Deterioration|"Structural deterioration was defined as any change in the study valve function which resulted from an intrinsic abnormality that caused stenosis or regurgitation.~There were no cases of structural deterioration reported for the study.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year|||Number
1418011|NCT01116024|Primary|Hemolysis|Blood data analysis was performed in order to identify whether particular complications and serious adverse events such as hemolysis occurred. Hemolysis in subjects with tissue valves – as evidenced by increased serum lactate dehydrogenase concentrations, decreased serum haptoglobin concentration, erythrocytopenia and reticulocytosis – is usually associated with paravalvular leakage or infection.|Five Years||||participants|||Number
1418012|NCT01116024|Primary|Endocarditis|"Endocarditis was defined in the protocol as any infection involving the study valve. Any structural/non-structural valvular dysfunction, thrombosis, or embolic event associated with study valve endocarditis was captured as endocarditis only.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
1418013|NCT01116024|Primary|Paravalvular Leaks (All and Major)|"Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis (between the sewing ring and native annulus). Major Paravalvular leak was defined as any evidence of leakage of blood around the prosthesis, i.e. between the sewing ring and native annulus that requires surgical intervention.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
1418014|NCT01116024|Primary|Hemorrhage/Bleeding-Anticoagulant/Antiaggregant (All and Major)|"Any episode of internal or external bleeding in subjects receiving anticoagulant and/or antiaggregant therapy.~Hemorrhage/Bleeding (No Anticoagulant/Antiaggregant):~Any episode of internal or external bleeding in subjects not receiving anticoagulant and/or antiaggregant therapy.~The results are reported as linearized rate (percentage of participants per patient-year)."|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
1418015|NCT01116024|Primary|Thromboembolism/Thrombosis|"Valve related thromboembolism and valvular thrombosis.~Thrombosis was defined as any thrombus attached to or near the study valve that interfered with valve function in the absence of infection. The results are reported as linearized rate (percentage of participants per patient-year)"|Five Years||||percentage of participants/patient-year||95% Confidence Interval|Number
1418016|NCT01115998|Primary|Early Coping Inventory|We used the reactive and self-initiated behavior scales. We used change in raw scores for analyses. The worst possible raw score for each scale is 16 and the best possible score is 80.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.|||Units on scale||Inter-Quartile Range|Median
1418017|NCT01115998|Primary|Battelle Developmental Inventory (BDI)|Items measure adaptive, cognitive, communication, motor, and personal-social development using 3-point ordinal scales (0 = does not complete; 1 = partially completes; 2 = completes item). We used change in age equivalent scores for each area and the total scores for analyses. The worst possible scores are 0 months age equivalent and the best possible scores are 95 months age equivalent.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.|||Units on scale||Inter-Quartile Range|Median
1418018|NCT01115998|Primary|Pediatric Evaluation of Disability Inventory|Items measure mobility, self-care, and social function using a 2-point scale (0 = unable or limited ability; 1 = capable in most situations). Items measure caregiver assistance on a 6-point scale (0 = total assistance; 5 = independent). We used the change in scaled scores in each area and total scores for analyses. Worst possible scaled score is 0 and the best possible score is 100.|Baseline and 12 months|We did a per protocol analysis for 22 children who completed the study and an intention to treat (ITT) analysis for the 28 children for whom we had complete data at 12 months. The overall results of the ITT analysis did not differ from the per protocol analysis.|||Units on scale||Inter-Quartile Range|Median
1418019|NCT01115933|Secondary|Overall Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|0 - 298 days|FAS population|||percentage of participants|||Number
1418020|NCT01115933|Secondary|Late Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|31 - 298 days|FAS population|||percentage of participants|||Number
1418021|NCT01115933|Secondary|Acute/Subacute Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|0-30 days|FAS population|||percentage of participants|||Number
1418022|NCT01115933|Secondary|Subacute Stent Thrombosis|Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement.”|1-30 days|FAS population|||percentage of participants|||Number
1424576|NCT01059760|Primary|Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed||Baseline and 3 days||||cells/mL||Standard Deviation|Mean
1418033|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418034|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418035|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418036|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
1418037|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS population|||percentage of participants|||Number
1418038|NCT01115933|Secondary|Target Vessel Revascularization (TVR, Per ARC Definition)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|FAS Population|||percentage of participants|||Number
1418039|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS population|||percentage of participants|||Number
1418040|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
1418041|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418042|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
1418043|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|Any revascularization for in-segment restenosis will be considered TLR. “Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|9 months|FAS Population|||percentage of participants|||Number
1418044|NCT01115933|Secondary|Target Lesion Revascularization (TLR, Per ARC Definition)|Any revascularization for in-segment restenosis will be considered TLR.“Segment” is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.|1 month|Full analysis set (FAS) population|||percentage of participants|||Number
1419473|NCT01103466|Primary|Leakage Under the Base Plate|"Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is no leakage and 24 is complete leakage under the base plate."|At every change of base plate|ITT|||units on a scale||Standard Deviation|Mean
1418045|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418046|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|FAS Population|||percentage of participants|||Number
1418047|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418048|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG~Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves~Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418049|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418050|NCT01115933|Secondary|Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)|"Definitions in SPIRIT III Study:~Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351"|1 month|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418051|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.|9 months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418052|NCT01115933|Secondary|Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)|"DEATH (Per ARC Circulation 2007; 115: 2344-2351)~All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac."|1 month||||percentage of participants|||Number
1418053|NCT01115933|Secondary|Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.~PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)|||percentage of participants||95% Confidence Interval|Number
1418054|NCT01115933|Secondary|Late Loss (LL), In-segment, In-stent, Proximal and Distal|"LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up:~In-segment Late Loss: in-segment MLD post-procedure – in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure – in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure – proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure – distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)"|8 months|Full Analysis Set (FAS population)|||mm||Standard Deviation|Mean
1418055|NCT01115933|Secondary|Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal|"IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.~PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement"|8 months|Full Analysis Set (FAS population)|||percentage of DS||Standard Deviation|Mean
1418056|NCT01115933|Secondary|Procedural Success(Subject Base Analysis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|ITT population|||percentage of participants||95% Confidence Interval|Number
1418320|NCT01114438|Primary|Total Weight Change From Baseline to Week 52|Total weight change at 12 months (kg) compared to baseline|12 months|Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for weight loss analysis at the defined 12 month endpoint.|||kg||Standard Deviation|Mean
1418057|NCT01115933|Secondary|Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)|Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.|The period during an in-hospital stay of less than or equal to 7 days post index procedure.|Intent to Treat Population (ITT)|||percentage of participants||95% Confidence Interval|Number
1418058|NCT01115933|Primary|Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)|Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)|9 Months|Full Analysis Set (FAS population)|||percentage of participants|||Number
1418059|NCT01115855|Secondary|Change From Baseline in Specific Activity Scale (SAS) Score at Week 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|Specific activity scale was estimated by pre-specified questionnaire (for different activities) to assess the exercise capability of the participants. Answers provided by participants were transformed in terms of number of metabolic equivalents (METs).1 MET was defined as the amount of oxygen consumed while sitting at rest and is equal to 3.5 ml oxygen per kg body weight* minute. Scale ranged from 1 (less than (<) 2 METs) = lowest level of exercise tolerance to 6 (>=8METs) = highest level of tolerance and higher score indicated more tolerance.|Baseline, Week 4, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||metabolic equivalents (METs)||Standard Deviation|Mean
1418060|NCT01115855|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17 21, 25, 29, 33, 37, 42, 48 and Final Visit|NYHA: classified as ‘class I’ (participants with cardiac disease but without resulting limitations of physical activity), ‘class II’ (participants with cardiac disease resulting in slight limitation of physical activity), ‘class III’ (participants with cardiac disease resulting in marked limitation of physical activity), ‘class IV’ (participants with cardiac disease resulting in inability to carry on any physical activity without discomfort). Participants with change from baseline were classified as ‘improved' (positive change), ‘no change’ or ‘worsened' (negative change).|Baseline, Weeks 1, 4, Months 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||participants|||Number
1418061|NCT01115855|Secondary|Change From Baseline in Urine Albumin-to-Creatinine Ratio at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||microgram per gram creatinine (mg/gCr)||Standard Deviation|Mean
1418062|NCT01115855|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit|LVEF was calculated based on end-diastolic volume measured by two-dimensional echocardiography.|Baseline, Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of LVEF||Standard Deviation|Mean
1418063|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Serum N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5, 9, 13, 17, 21 ,25, 29, 33, 37, 42, 48 and Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||pg/mL||Standard Deviation|Mean
1418064|NCT01115855|Secondary|Change From Baseline in Plasma Concentration of Brain Natriuretic Peptide at Months 5, 9, 13, 17, 21, 25, 29, 33, 37, 42, 48 and Final Visit||Baseline, Months 5,9,13,17,21,25,29,33,37,42,48, Final Visit (up to Month 48)|Full analysis set included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||picogram/milliliter (pg/ml)||Standard Deviation|Mean
1418065|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization for Hyperkalemia|Hospitalization due to hyperkalemia (as per physician’s decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418066|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalisation Due to Worsening Renal Function|Hospitalization due to worsening renal function (as per physician’s decision) was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418067|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Diabetes Mellitus|New onset diabetes mellitus was defined as the diagnosis of diabetes mellitus in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1423525|NCT01069341|Secondary|Mean Time to Re-treatment|Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months)|first 12 months|All subjects' data was included|||months||Standard Deviation|Mean
1418068|NCT01115855|Secondary|Number of Participants With First Occurrence of New Onset Atrial Fibrillation/Flutter|New onset of atrial fibrillation or flutter was defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418069|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Myocardial Infarction (MI)|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418070|NCT01115855|Secondary|Number of Participants With First Occurrence of Fatal/Non-Fatal Stroke|Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418071|NCT01115855|Secondary|Number of Participants With First Occurrence of Addition/Increase of Heart Failure (HF) Medication Due to Heart Failure (HF) Worsening|Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percent or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418072|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization|CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418073|NCT01115855|Secondary|Number of Participants With First Occurrence of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization|HF mortality was defined as any death due to HF. Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418074|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Mortality or All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418075|NCT01115855|Secondary|Number of Participants With First Occurrence of Hospitalization Due to Heart Failure (HF)|Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418076|NCT01115855|Secondary|Number of Participants With First Occurrence of All-cause Hospitalization|All cause hospitalization included all hospitalizations as CV hospitalization, which was defined as any hospitalization due to CV events including HF, myocardial infarction, arrhythmia, angina pectoris and non-CV hospitalizations which was defined as any hospitalization due to non-CV events including renal dysfunction, hyperkalaemia, malignant tumor and pulmonary disease. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418077|NCT01115855|Secondary|Number of Participants With With First Occurrence of Cardiovascular Mortality|CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418078|NCT01115855|Secondary|Number of Participants With With First Occurrence of All-Cause Mortality|All-cause mortality was defined as any CV mortality, Non-CV mortality, including malignant tumor, pulmonary disease and trauma.CV mortality was defined as death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Mortality during treatment, within 30 days of treatment discontinuation and after 30 days of discontinuation was reported. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1424577|NCT01059760|Primary|Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed||Baseline and 3 days||||pg/mL||Standard Deviation|Mean
1418079|NCT01115855|Secondary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Addition/ increase of HF medications was defined as administration of new HF medication or increase of 50 percentage (%) or more in dose of HF medication for >= 3 days. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418080|NCT01115855|Primary|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)|CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.|Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)|Full analysis set included all randomized participants.|||participants|||Number
1418081|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) at 6 Hours Post-Prasugrel Loading Dose (LD) by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|6 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had PRU measurements 6 hours after prasugrel LD and provided a DNA sample.|||PRU||Standard Error|Least Squares Mean
1418082|NCT01115738|Secondary|P2Y12 Reaction Units (PRU) of Clopidogrel Treated Participants at Baseline by Cytochrome P450 2C19 (CYP2C19)-Predicted Functional Groups - CYP2C19 Extensive Metabolizers (EM) and Reduced Metabolizers (RM)|CYP2C19 is a drug metabolizing enzyme. CYP2C19 Extensive metabolizers (EM) are individuals with two fully active / normal function CYP2C19 alleles (*1/*1, *1/*17). CYP2C19 Reduced metabolizers (RM) are individuals with at least one reduced-function CYP2C19 allele (*2/*2, *1/*2). Least Squares (LS) Mean values were controlled for CYP2C19 genetic group.|Baseline|All randomized participants who were treated with Clopidogrel and had PRU measurement at Baseline and provided a DNA sample.|||PRU||Standard Error|Least Squares Mean
1418083|NCT01115738|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAE is a worsening or new occurrence of adverse event (AE) during treatment compared to baseline. A summary of serious adverse events (SAE) and other nonserious AE are located in the Reported Adverse Events section.|Baseline through 72 hours after prasugrel loading dose|Participants who received any treatment.|||participants|||Number
1418084|NCT01115738|Secondary|Percentage of Poor Responders|Poor responders are those who had P2Y12 Reaction Units (PRU)≥ 240.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.|||percentage of participants|||Number
1418085|NCT01115738|Secondary|Percentage of Inhibition of Platelet Aggregation|Adenosine Diphosphate (ADP)-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. The internal BASE standard is an independent measurement and serves as an estimate of the participant’s baseline platelet aggregation independent of P2Y12 receptor inhibition. Percent Inhibition of Platelet Aggregation=(1-[PRU/BASE) x 100%, high numbers represent increased platelet inhibition. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 and 6 and 24 and 72 hours after loading dose|All randomized participants who received prasugrel loading dose (LD) and had at least one evaluable PRU measurement after prasugrel LD.|||percentage of inhibition||Standard Error|Least Squares Mean
1418086|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hemoglobin||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hemoglobin measurement 72 hours after LD.|||gram per deciliter (g/dL)||Standard Deviation|Mean
1418087|NCT01115738|Secondary|Mean Change From Baseline to 72 Hours in Laboratory Measurements - Hematocrit||Baseline, 72 hours|All randomized participants who received prasugrel loading dose (LD) and had a Hematocrit measurement 72 hours after LD.|||proportion of 1.0||Standard Deviation|Mean
1418088|NCT01115738|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation at Baseline, 2, 24 and 72 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|Baseline and 2 hours and 24 hours and 72 hours after prasugrel loading dose|All randomized participants who received prasugrel LD and had at least one evaluable PRU measurement after prasugrel LD.|||PRU||Standard Error|Least Squares Mean
1418089|NCT01115738|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-Mediated Platelet Aggregation 6 Hours After Prasugrel Loading Dose (LD)|ADP-induced P2Y12 receptor mediated platelet aggregation serves as a biomarker of platelet function. It is measured in P2Y12 Reaction Units (PRU) with lower PRU reflecting stronger inhibition of P2Y12 and reduced platelet aggregation. Least Squares (LS) Mean values were controlled for treatment, visit, treatment and visit interaction, and country.|6 hours after prasugrel loading dose|All randomized participants who received the prasugrel LD and had at least one evaluable PRU measurement after LD.|||PRU||Standard Error|Least Squares Mean
1423526|NCT01069341|Secondary|Macular Volume|Macular volume (millimeters cubed [mm3]) by Stratus OCT|at months-1,3,7, and 12|All subjects' data was analyzed, no subjects were excluded|||Macular volume (millimeters cubed)||Standard Deviation|Mean
1418090|NCT01115699|Secondary|Change in Quick Inventory of Depressive Symptoms - Clinician Rating 16 Item (QIDS-C16)|"The QIDS-C16 measures 16 factors across 9 different criterion domains for major depression. Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following:the highest number from questions 1-4 + the number from question 5 + the highest number from questions 6-9 + the total of each question from 10-14 + the highest number from questions 15-16.~Screening test scoring ranges:~0-5, No Depression Likely~6-10, Possibly Mildly Depressed~11-15, Moderate Depression~16-20, Severe Depression~21 or Over, Very Severe Depression"|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.||||||
1418091|NCT01115699|Primary|Change in Hamilton Rating Scale for Depression (HRS-D17)|The HRS-D17 questionnaire has 17 items. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.|baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, and 6 weeks|This study was stopped early due to funding constraints and recruitment was slower than was expected.||||||
1418092|NCT01115673|Secondary|Patient Global Evaluation|Patient Assessment of the Pain Medication – Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Units on a scale||Standard Error|Least Squares Mean
1418093|NCT01115673|Secondary|Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score|Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Percentage of Participants|||Number
1418094|NCT01115673|Secondary|Rescue Rates Through Six Hours|Percentage of subjects using rescue medication.|through 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Percentage of Participants|||Number
1418095|NCT01115673|Secondary|Rescue Rates Through Four Hours|Percentage of subjects using rescue medication.|through 4 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Percentage of Participants|||Number
1418096|NCT01115673|Secondary|Duration of Analgesia – Time to Rescue|Minutes until rescue medication was given.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Minutes||Full Range|Median
1418097|NCT01115673|Secondary|Time to Confirmed Perceptible Pain Relief|Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Minutes||Full Range|Median
1418098|NCT01115673|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|within 6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||Minutes||Full Range|Median
1418099|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418100|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418101|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1423527|NCT01069341|Secondary|Presence of Proliferative Diabetic Retinopathy (PDR)|Presence of proliferative diabetic retinopathy by fluorescein angiogram|at month-12|All subjects' data was analyzed, no subjects were excluded|||participants|||Number
1418102|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418103|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418104|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418105|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418106|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418107|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418108|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418109|NCT01115673|Secondary|Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes|Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418110|NCT01115673|Secondary|Pain Relief (PAR) Scores at 360 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418111|NCT01115673|Secondary|Pain Relief (PAR) Scores at 300 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418112|NCT01115673|Secondary|Pain Relief (PAR) Scores at 240 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1419634|NCT01101867|Secondary|Postprandial Glucose|Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.|||mg/dl||Standard Deviation|Mean
1418113|NCT01115673|Secondary|Pain Relief (PAR) Scores at 180 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418114|NCT01115673|Secondary|Pain Relief (PAR) Scores at 120 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418115|NCT01115673|Secondary|Pain Relief (PAR) Scores at 90 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418116|NCT01115673|Secondary|Pain Relief (PAR) Scores at 75 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418117|NCT01115673|Secondary|Pain Relief (PAR) Scores at 60 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418118|NCT01115673|Secondary|Pain Relief (PAR) Scores at 45 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418119|NCT01115673|Secondary|Pain Relief (PAR) Scores at 30 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418120|NCT01115673|Secondary|Pain Relief (PAR) Scores at 15 Minutes|Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418121|NCT01115673|Secondary|Pain Intensity Difference (PID) at 360 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|360 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418122|NCT01115673|Secondary|Pain Intensity Difference (PID) at 300 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|300 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418123|NCT01115673|Secondary|Pain Intensity Difference (PID) at 240 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|240 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418152|NCT01115491|Secondary|Overall Survival - Time to Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population|||weeks||95% Confidence Interval|Median
1418124|NCT01115673|Secondary|Pain Intensity Difference (PID) at 180 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|180 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418125|NCT01115673|Secondary|Pain Intensity Difference (PID) at 120 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|120 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418126|NCT01115673|Secondary|Pain Intensity Difference (PID) at 90 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|90 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418127|NCT01115673|Secondary|Pain Intensity Difference (PID) at 75 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|75 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418128|NCT01115673|Secondary|Pain Intensity Difference (PID) at 60 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|60 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418129|NCT01115673|Secondary|Pain Intensity Difference (PID) at 45 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|45 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418130|NCT01115673|Secondary|Pain Intensity Difference (PID) at 30 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|30 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418131|NCT01115673|Secondary|Pain Intensity Difference (PID) at 15 Minutes|Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.|15 Minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418132|NCT01115673|Secondary|Sum of Pain Relief Scores Over Six Hours (TOTPAR6)|Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418153|NCT01115491|Secondary|Overall Survival - Percentage of Participants With an Event|Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.|BL, every 28 days, until death or end-of-study, an average of 32 weeks|ITT population|||percentage of participants|||Number
1418133|NCT01115673|Secondary|Sum of Pain Intensity Difference Over Six Hours (SPID6)|Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418134|NCT01115673|Primary|Overall Analgesic Efficacy – Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)|Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.|6 Hours|Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.|||units on a scale||Standard Error|Least Squares Mean
1418135|NCT01115660|Secondary|Follow up Appointment With MD|Follow up appointment with primary care provider since stroke|3 months|Patients who were contacted at 3 months|||participants|||Number
1418136|NCT01115660|Primary|Feasibility of Intervention (Ability to Reach Patients at 3 Months)|Number of patients contacted at 3 months|3 months|All eligible patients who also were available at 3 months for post-intervention follow-up call.|||number of patients contacted|||Number
1418137|NCT01115582|Secondary|Total Bilirubin|Concentration of total bilirubin in serum|At baseline and after 30 days of treatment|All patients entered and treated|||mg/dL||Standard Deviation|Mean
1418138|NCT01115582|Secondary|Physical Examination|Total number of patients with abnormal findings from general physical examination|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated|||participants|||Number
1418139|NCT01115582|Secondary|Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP)|At baseline and after 30 days of treatment|All patients entered and treated|||mmHg||Standard Deviation|Mean
1418140|NCT01115582|Secondary|Adverse Events|Total number of patients with any adverse events|Total of 30 days, i.e. from the time point the patients entered into the study up to the end of treatment|All patients entered and treated|||participants|||Number
1418141|NCT01115582|Primary|Serum and Urine Bile Acids|Concentration of bile acids in serum (S) and urine (U). (abbreviations: chol.=cholenoic; monohydro=monohydroxy; dihydro=monohydro)|At baseline (BL) and after 30 days of treatment (D30)|All patients entered and treated|||mmol/L||Standard Deviation|Mean
1418142|NCT01115582|Primary|Serum Transaminases|Concentration of serum alanine transaminase (ALT) and aspartate transaminase (AST)|At baseline and after 30 days of treatment|All patients entered and treated|||U/L||Standard Deviation|Mean
1418143|NCT01115569|Secondary|Maintenance of Efficacy|Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication|1 year|||||||
1418144|NCT01115569|Primary|Mean Change in Average Daily Pain|Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.|1 year|The number of participants for analysis was determined by the safety population. Numeric Rating Scale (NRS) for Pain assessment was used. Measure is mean change in average daily pain intensity. Total number of participants providing end of study pain intensity score = 391.|||units on a scale||Standard Deviation|Mean
1418145|NCT01115556|Secondary|Mean Change in Visual Acuity (VA) From Baseline at Month 12|"Mean change in Visual Acuity (VA) from Baseline at Month 12~Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12~Mean change in leakage as determined by FA at Months 6 and 12~Mean number of ranibizumab injections at Months 6 and 12~Mean time to first re-treatment following the initial 3 monthly loading doses~Mean duration of fluid-free interval~Safety and tolerability of 2.0mg using the incidence and severity of adverse events"|one year||||ETDRS Letters||Standard Deviation|Mean
1418146|NCT01115556|Primary|Mean Change in Visual Acuity (VA) From Baseline at Month 6||Baseline and 6 months||||ETDRS Letters||Standard Deviation|Mean
1418147|NCT01115517|Secondary|Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year||1 year||||participants|||Number
1418148|NCT01115517|Secondary|Number of Participants Who Had Complications From the Time of Treatment to Recurrence||1 year||||participants|||Number
1418149|NCT01115517|Primary|Number of Participants Who Had Recurrence of Pterygia up to 1 Year||1 year||||participants|||Number
1418150|NCT01115491|Secondary|Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)|Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population|||percentage of participants|||Number
1418151|NCT01115491|Primary|PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study||BL, 24 weeks (after 6th cycle)|ITT population|||survival probability|||Number
1418154|NCT01115491|Primary|PFS - Time to Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.|BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population|||weeks||95% Confidence Interval|Median
1418155|NCT01115491|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.|Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks|ITT population|||percentage of participants|||Number
1418156|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418157|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 5 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418158|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a VAS in 5% Potassium Nitrate Solution and Water; 2.5% Potassiun Nitrate Solution and Water|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418159|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli 20 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418160|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418161|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 4 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 4|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1424578|NCT01059760|Primary|Change From Baseline in Participant Adiponectin When Fasting and Fed||Baseline and 3 days||||ratio of high molecular to total||Standard Deviation|Mean
1418162|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated.|||units on a scale||95% Confidence Interval|Mean
1418163|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418164|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 3 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 3|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418165|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418166|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418167|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Following Treatment on Day 2 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 2|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418168|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 20 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418254|NCT01114672|Primary|Severity of Pruritis|"Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis.~Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis."|Baseline and end of study (up to 12 weeks)|Number randomized in each arm 25|||units on a scale||Standard Deviation|Mean
1418169|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and 10 mins post treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418170|NCT01115452|Secondary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 1|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418171|NCT01115452|Primary|Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution|"Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline."|Baseline and immediately after treatment on Day 5|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. There was no imputation for missing data. Analysis population was less than the randomized population because 2 participants had one tooth which was not treated|||units on a scale||95% Confidence Interval|Mean
1418172|NCT01115244|Secondary|Evaluation of Clinical Photographs and Scoring of Photographs Based on a Modified Global Acne Assessment Score|Photographs of the treated and control extremity of each patient will be presented to the investigator in a blinded manner. Scores will be assigned according to a modified Global Acne Assessment Score. This scoring system has previously been used to evaluate the efficacy of dapsone gel, 5% in the treatment of acne. The designated score is based on disease severity, number of lesions, and type of lesions.|6 weeks of treatment|||||||
1418173|NCT01115244|Secondary|Number of Papules, Plaques and Vesicles on Treated and Untreated Elbows or Knees of Patients Who Have One Extremity Treated With Dapsone Gel, 5%|Lesion types will be counted at recorded at each visit. The mean lesion counts for papules, plaques and vesicles, as well as mean reduction of disease burden from baseline at week six for each of these categories, will be determined.|6 weeks of treatment|||||||
1418174|NCT01115244|Primary|Number and Size of All Lesions on the Treated and Untreated Elbows or Knees of Patients With Dermatitis Herpetiformis Who Have One Extremity Treated With Dapsone Gel, 5%|The primary objective is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Digital photographs of each elbow or each knee (treatment and control) will be taken. The number and size of lesions will be recorded for the treatment and control elbow or knee. This process will be repeated at each follow up visit.|6 weeks of treatment|||||||
1418175|NCT01115166|Other Pre-specified|Fluid Extravasation|Rate of fluid transfer from the intravascular to the extravascular compartment during two distribution half-times. Graph derived from the hemoglobin change during 20 to 30 minutes after start of cardio pulmonary by-pass.|Two distribution half-times. Approximately 16 minutes.|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.|||mL/kg/min||Standard Deviation|Median
1418176|NCT01115166|Secondary|Intracellular Edema|"Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.~A positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass."|30 minutes after CPB|Mainly observational. 10 patients were regarded to be a sufficient number to se a tendency.|||Litre||Standard Deviation|Mean
1418177|NCT01115166|Primary|Blood Volume|"volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.~The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.~The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.~To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated."|30 minutes after start of CPB|The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.|||Litre||Standard Deviation|Mean
1418178|NCT01115101|Secondary|Costs|Evaluation costs between groups|6 month|||||||
1418179|NCT01115101|Secondary|Mobilisation|Evaluation of time to post surgical mobilization|6 month|||||||
1418180|NCT01115101|Secondary|Side Effects|Evaluation of side effects|6 month|||||||
1418181|NCT01115101|Secondary|Subgroups|Secondary Outcome Measures were to identify subgroups in benefit of either therapy.|6 month|||||||
1418255|NCT01114646|Secondary|Energy/Fatigue Scale|An inquire about fatigue, level of energy and self-efficiency.|1 year|||||||
1418182|NCT01115101|Primary|Difference of Pain Scores on the Visual Analog Scale|"The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline.~For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain.~Single value were calculated (averaged)."|Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.|The sample size (intention to treat) was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.|||VAS score at 24 hours||Standard Deviation|Mean
1418183|NCT01114997|Secondary|Post-anesthesia Care Unit (PACU) Stay||1 day||||Minutes||Standard Deviation|Mean
1418184|NCT01114997|Secondary|Patient Satisfaction|Patient satisfaction using a verbal rating scale from 0 to 10 0= Not satisfied 10= Excellent|1 month||||Score on a scale||Standard Deviation|Mean
1418185|NCT01114997|Secondary|Return to Normal Activities of Daily Living Using Follow up Questionnaires|Description: return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)|1 month||||participants|||Number
1418186|NCT01114997|Secondary|Number of Participants With Postoperative Nausea One Day After Surgery|Postoperative nausea using a Verbal Rating Scale Outcomes measured at the first day after surgery|1day||||participants|||Number
1418187|NCT01114997|Secondary|Opioid Consumption Obtained From the Recorded Data|Postoperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|1 day|Opioid: Hydromorphone|||mg||Standard Deviation|Mean
1418188|NCT01114997|Primary|Number of Participants With Post Operative Pain One Month After Surgery|"Highest Post Operative pain one month after surgery, using a verbal rating score from 0 (no pain) to 10 (highest level of pain).~Patient received a post-operative follow-up call one month after surgery."|1 month|Experience of pain at home|||participants|||Number
1418189|NCT01114997|Primary|Post Operative Pain|Outcome had a duration of one day at post-anesthesia care unit (PACU) Postoperative pain measured using a Verbal Rating Scale (VRS) Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain.|1 day||||Score on a scale||Standard Deviation|Mean
1418190|NCT01114945|Primary|Glottis View Using the Cormack Lehane Score|"Cormack Lehane score classification:~Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible"|Up to 1 minute|Cormack Lehane score (grade:1/2/3/4 [n])|||participants|||Number
1418191|NCT01114945|Primary|Percentage of Glottic Opening (POGO) [%]|"POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%.~View of the glottic opening (0-100%) during the intubation process."|up to 1 minute||||percentage of glottis opening||Standard Deviation|Mean
1418192|NCT01114945|Primary|Time to Obtain Glottis Visualization (Seconds)|"It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view.~Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery"|up to 1 minute||||Seconds||Standard Deviation|Mean
1418193|NCT01114945|Primary|Intubation Time Using a Stop Watch|Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.|up to 3 minutes|"Times following initial insertion of laryngoscope blade:~to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec)"|||Seconds||Standard Deviation|Mean
1418194|NCT01114893|Secondary|IOP Change From Baseline at 8 PM on Day 5|Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment|5 Days||||mm Hg||95% Confidence Interval|Mean
1418195|NCT01114893|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5|Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment|5 days||||mm Hg||95% Confidence Interval|Mean
1418196|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 24|ITT analysis set, observed cases|||units on a scale||Standard Deviation|Mean
1418197|NCT01114880|Secondary|Change From Baseline in 36-item Short Form Questionnaire Version 2 (SF-36v2) Physical Component Summary Score|The SF-36 questionnaire, version 2, consists of 36 general health questions with 2 components, physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline and Week 12|ITT analysis set, observed cases|||units on a scale||Standard Deviation|Mean
1418198|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 24|ITT analysis set, LOCF|||milligrams/liter||Standard Deviation|Mean
1418199|NCT01114880|Secondary|Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)|Elevation of hs-CRP is a nonspecific marker of inflammation. Values above 5 milligrams/liter (mg/L) were considered abnormally high. Decrease in level of hs-CRP indicates reduction in inflammation.|Baseline and Week 12|ITT analysis set, LOCF|||milligrams/liter||Standard Deviation|Mean
1418256|NCT01114646|Secondary|Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale|A modified version of the Older Americans Resources and Services Instrument (OARS) which asks about performance of tasks of daily living during the preceding two weeks.14 These activities include: getting to places, walking distances, shopping for groceries or clothes, preparing meals and doing housecleaning.|1 year|||||||
1418200|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418201|NCT01114880|Secondary|Number of Participants Meeting the Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) BASDAI50 Response Criteria|"A BASDAI50 responder had at least a 50% improvement from Baseline in BASDAI score. In the BASDAI, participants use a 10-centimeter visual analog scale to answer 6 questions pertaining to symptoms experienced in the preceding week (e.g., How would you describe the overall level of fatigue/tiredness you have experienced? How long does your morning stiffness last from the time you wake up?) Responses range from none to very severe or from 0 hours to 2 or more hours for morning stiffness. The score is calculated as 0.2 (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2)."|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418202|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 24|ITT analysis set, LOCF|||centimeters||Standard Deviation|Mean
1418203|NCT01114880|Secondary|Change From Baseline in Inflammation Score|"The Inflammation score is the mean of the 10-cm visual analog scale scores from the 2 morning stiffness-related BASDAI questions: How would you describe the overall level of morning stiffness you have had from the time you wake up?, with response ranging from none to very severe; and How long does your morning stiffness last from the time you wake up?, with response ranging from 0 hours to 2 or more hours."|Baseline and Week 12|ITT analysis set, LOCF|||centimeters||Standard Deviation|Mean
1418204|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 24|ITT analysis set, LOCF|||units on a scale||Standard Deviation|Mean
1418205|NCT01114880|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|Participants assessed their ability to perform 10 selected activities (e.g., putting on socks or tights without help or aids, bending forward from the waist to pick up a pen from the floor without an aid) during the preceding week. Responses ranged from 0 (easy) to 100 (impossible). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 100.|Baseline and Week 12|ITT analysis set, LOCF|||units on a scale||Standard Deviation|Mean
1418206|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 24|ITT analysis set, LOCF|||millimeters||Standard Deviation|Mean
1418207|NCT01114880|Secondary|Change From Baseline in Total Back Pain Score|Participants assessed their total back pain within the preceding week using a total back pain 100 mm visual analog scale, with responses ranging from no pain (0) to most severe pain (100).|Baseline and Week 12|ITT analysis set, LOCF|||millimeters||Standard Deviation|Mean
1418208|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 24|ITT analysis set, missing data imputed by last observation carried forward (LOCF)|||millimeters||Standard Deviation|Mean
1418209|NCT01114880|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|Participants assessed their disease activity during the preceding week using a 100 millimeter (mm) visual analog scale, with responses ranging from no activity (0) to severe activity (100).|Baseline and Week 12|ITT analysis set, missing data imputed by last observation carried forward (LOCF)|||millimeters||Standard Deviation|Mean
1418210|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418211|NCT01114880|Secondary|Number of Participants With ASAS Partial Remission|Participants were classified as having achieved ASAS partial remission if they had a value of less than 20 on a scale from 0 (normal/none) to 100 (most severe) in each of 4 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); and inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418212|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418213|NCT01114880|Secondary|Number of Participants Meeting the ASAS5/6 Response Criteria|An ASAS5/6 responder had an improvement from Baseline of 20% or more in 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; pain as measured by the Total Back Pain visual analog scale (VAS); function as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI); inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); spinal mobility (lateral lumbar flexion from Bath Ankylosing Spondylitis Metrology Index [BASMI]); and acute phase reactant (high-sensitivity C-reactive protein).|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418214|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418215|NCT01114880|Secondary|Number of Participants Meeting the ASAS40 Response Criteria|An ASAS40 responder had improvement of 40% or more and absolute improvement of 20 units or more (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the 4 domains identified above for the ASAS20. In addition, there must have been an absence of deterioration in the potential remaining domain, where deterioration was defined as a net worsening of greater than 0 units (on a scale of 0 to 100).|Week 12|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418216|NCT01114880|Secondary|Number of Participants Meeting the ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 24|ITT analysis set, missing data imputed by NRI|||participants|||Number
1418217|NCT01114880|Primary|Number of Participants Meeting the Assessment of Spondyloarthritis International Society (ASAS) ASAS20 Response Criteria|ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 [least] to 100 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores).|Week 12|Analysis was performed on the Intent-to-Treat (ITT) analysis set, which included all subjects who were randomized and received at least 1 dose of double-blind study drug. A non-responder (NRI) imputation was used in which a missing response was imputed as non-response.|||participants|||Number
1418218|NCT01114828|Secondary|Ascites Volume as Measured by CT|Change from baseline (day-1) for ascites volume as measured by CT at the end of treatment (LOCF) were calculated.|Baseline, Day 7 or at the discontinued of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.|||mL||Standard Deviation|Mean
1418219|NCT01114828|Primary|Body Weight|Changes from baseline (day-1) for body weight at the end of treatment (LOCF) were calculated.|Bseline, Day 7 or at the discontined of treatment|For efficacy analysis set, 3 participants of 3.75 mg arm were excluded by violation of protocol and one participant of 7.5 mg arm was excluded by concomitant edematous disorders other than hepatic.|||kg||Standard Deviation|Mean
1418220|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26||||T score||95% Confidence Interval|Least Squares Mean
1418221|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 26||||T score||95% Confidence Interval|Least Squares Mean
1418222|NCT01114737|Primary|Number of Participants With a Score of 1 or 2 in Global Function Evaluation (CGI-I) From Baseline to Week 13.|"Effects of 6R-BH4 on global function in PKU subjects in subjects that had a blood Phe level reduction after treatment with 6R-BH4 at screening.~The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse."|13 weeks|Missing data for 1 subject in the Responders in 6R-BH4 20 mg/kg/day Arm|||Number of participants with scale 1 or 2|||Number
1418223|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Mean
1418257|NCT01114646|Primary|Post-Operative Myocardial Infarction|Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.|1 week post-operation|||||||
1418224|NCT01114737|Secondary|Change in Hamilton Rating Scale For Depression (HAM-D) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Least Squares Mean
1418225|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Least Squares Mean
1418226|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 26||||units on a scale||95% Confidence Interval|Least Squares Mean
1418227|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is <18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
1418228|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on executive function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Week 13 to Week 26|Phe Responders who is >=18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
1418229|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on global function through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Week 13 to Week 26|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
1418230|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on depression through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Week 13 to Week 26|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
1418231|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on anxiety through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Week 13 to Week 26|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
1418232|NCT01114737|Secondary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Week 13 to Week 26|"Durability of the therapeutic effect of 6R-BH4 on ADHD through 26 weeks in subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Week 13 to Week 26|Phe Responders with ADHD Symptoms|||units on a scale||95% Confidence Interval|Least Squares Mean
1418233|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Parent-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are <18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
1418234|NCT01114737|Secondary|Change in Behavior Rating Inventory of Executive Function (BRIEF) Adult-Global Executive Composite (GEC) T Score From Baseline to Week 13|"Effects of 6R-BH4 on executive function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~The scoring for the GEC T Score is complex and is achieved using proprietary software designed to generate scores based on raw data collected. Higher scores suggest a higher level of dysfunction."|Baseline to Week 13|Phe Responders who are >=18 Years of Age|||T score||95% Confidence Interval|Least Squares Mean
1418235|NCT01114737|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to Week 13|"Effects of 6R-BH4 on global function in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the subject’s mental illness at the time of assessment, relative to clinician’s past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on the severity of mental illness at the time of rating as: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 6, severely ill; or 7, among the most extremely ill."|Baseline to Week 13|Phe Responders|||units on a scale||95% Confidence Interval|Least Squares Mean
1418236|NCT01114737|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of depression in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-D Score is a total score ranging from 0 to 48 with higher scores corresponding to worse severity of depression. The HAM-D is a 17-item depression rating scale. Nine of the items are scored on a 5-point scale as: 0, absence of depressive symptom being measured; 1, doubt concerning the presence of the symptom; 2, mild symptoms; 3, moderate symptoms; or 4, severe symptoms. The remaining 8 items are scored on a 3-point scale as: 0, absence; 1, doubt on the presence of the symptom; or 2, clear presence of symptoms."|Baseline to Week 13||||units on a scale||95% Confidence Interval|Least Squares Mean
1418237|NCT01114737|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of anxiety in PKU subjects who had a blood Phe level reduction after treatment with 6R-BH4.~HAM-A Score is a total score ranging from 0 to 56 with higher scores corresponding to worse severity of anxiety symptoms. The HAM-A has 14 items, each measuring specific anxiety symptom clusters. Each item is given a 5-point-score as: 0, absent; 1, mild; 2, moderate; 3, severe; or 4, incapacitating."|Baseline to Week 13||||units on a scale||95% Confidence Interval|Least Squares Mean
1418238|NCT01114737|Primary|Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 13|"Effects of 6R-BH4 on symptoms of ADHD in PKU subjects who had symptoms of ADHD at screening in the subjects that had a blood Phe level reduction after treatment with 6R-BH4.~The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms."|Baseline to Week 13||||units on a scale||95% Confidence Interval|Least Squares Mean
1418239|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn or were lost to follow-up before the lower limit of the 12 mos follow-up window.One subject was lost to follow-up and one withdrew before 12 mos. One of these subjects experienced an AE before study exit and was included in the analysis,|||participants|||Number
1418240|NCT01114724|Secondary|Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.||at 30 days|Based on number of ITT subjects with available data.|||participants|||Number
1418241|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
1418242|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
1418243|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 12 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
1418244|NCT01114724|Secondary|Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft||at 6 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
1418245|NCT01114724|Secondary|Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment||At 12 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
1418246|NCT01114724|Secondary|Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment||At 6 months|Based on number of ITT subjects with evaluable imaging data.|||participants|||Number
1418247|NCT01114724|Secondary|Subjects With Secondary Endovascular Procedures||Through12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)|||participants|||Number
1418248|NCT01114724|Secondary|Aortic Rupture||Within 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)|||participants|||Number
1418249|NCT01114724|Secondary|Aortic Rupture||Within 30 days|Based on number of ITT subjects with available data.|||participants|||Number
1418250|NCT01114724|Secondary|Subjects With Coverage of Primary Tear||At implant|Based on number of ITT subjects with available data|||participants|||Number
1418251|NCT01114724|Secondary|Subjects With Successful Delivery and Deployment of the Device.||At implant.|Based on number of ITT subjects with available data|||participants|||Number
1418252|NCT01114724|Secondary|All-cause Mortality||at 12 months|Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up)|||participants|||Number
1418253|NCT01114724|Primary|All Cause Mortality.||Up to 30 days after the stent graft implant.|Based on number of ITT subjects with available data|||participants|||Number
1418258|NCT01114646|Primary|Post-Operative Unstable Angina|Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.|1 week post-operation|||||||
1418260|NCT01114620|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 182)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418261|NCT01114620|Secondary|Number of Subjects With Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Subjects|||Number
1418262|NCT01114620|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418263|NCT01114620|Secondary|Number of Subjects With Abnormal Urine Sampling Parameters|Among assessed urine sampling parameters were glucose, protein, red blood cells and urobilinogen.|At Day 0 and Day 7|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418264|NCT01114620|Secondary|Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels|"Among hematological and biochemical parameters assessed were alanine aminotransferase (ALAT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (ASAT), basophils, total bilirubin, bilirubin conjugated/direct, cholesterol, chloride, creatine, creatine kinase (CK), eosinophils, gamma-glutamyl transpeptidase (GGT), hematocrit, hemoglobin, potassium, lactate dyhydrogenase (LDH), lymphocytes, monocytes, sodium, neutrophils, platelets, protein, red blood cells, urate/uric acid, blood urea nitrogen (BUN) and white blood cells.~Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter."|At Day 0 and Day 7|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418265|NCT01114620|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Day 0 up to Day 182)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418266|NCT01114620|Secondary|Number of Subjects With MAEs|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418267|NCT01114620|Secondary|Number of Subjects With Medically Attended AEs (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418268|NCT01114620|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
1418269|NCT01114620|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C to ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418270|NCT01114620|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Days||Inter-Quartile Range|Median
1418271|NCT01114620|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1418272|NCT01114620|Secondary|Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease|VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
1418273|NCT01114620|Secondary|Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease|VRR for microneutralization titers was defined as the proportion of vaccinees with at least a 4-fold increase in post-vaccination reciprocal titer relative to Day 0. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1418274|NCT01114620|Secondary|Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1418275|NCT01114620|Secondary|Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:8. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1418276|NCT01114620|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
1418277|NCT01114620|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:8 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Netherlands/602/2009 (H1N1) (Flu A/Neth/602/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/Netherlands-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1418278|NCT01114620|Secondary|GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Fold change||95% Confidence Interval|Geometric Mean
1418279|NCT01114620|Secondary|Number of Seroprotected Subjects for HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
1418280|NCT01114620|Secondary|Number of Seroconverted Subjects for HI Antibodies|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
1418281|NCT01114620|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1418282|NCT01114620|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1418283|NCT01114620|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 and 182 days after vaccination were available.|||Participants|||Count of Participants
1418284|NCT01114620|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1418285|NCT01114620|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Fold change||95% Confidence Interval|Geometric Mean
1418286|NCT01114620|Primary|Number of Seroprotected Subjects for HI Antibodies|Seroprotection (SPR) was defined as the proportion of subjects with H1N1 reciprocal HI titers equal to or above (≥) 40 against the tested vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1418287|NCT01114620|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies|Seroconversion (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.|||Participants|||Count of Participants
1418288|NCT01114581|Secondary|Assess Sputum Properties (Objective Measures) and Symptoms (Subjective Measures) After Treatment With Mucinex or Placebo.||Within 10 days of developing symptoms associated with a respiratory tract infection|||||||
1418289|NCT01114581|Secondary|Guaifenesin AUC(0-3)||3 hours following dose administration||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1418290|NCT01114581|Primary|Percent of Inhaled Radioactive Tracer Particles Cleared From Lungs|Percentage of inhaled radioactive tracer (Ave180Clear)|3 hours following inhalation of radioactive tracer particles|Intent to treat|||Percentage of inhaled radioactive tracer||Standard Deviation|Mean
1418291|NCT01114529|Secondary|Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis)|(treated BPAR ≥ IB, graft loss or death)A comparison of the incidence rates for the individual components of the composite efficacy endpoint between treatment arms|at 24 months post-transplantation|Full Analysis Set|||Number of incidence|||Number
1418292|NCT01114529|Secondary|Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24|Evolution of left ventricular mass and hypertrophy were evaluated by left ventricular mass index (LVMi) assessed by echocardiography. LVMi is derived using a standard formula from dimensional measurements on the echocardiogram. Analysis of covariance was applied with treatment, center (as a random effect), and donor type as factors and LVMi at Randomization as covariate.|Randomization, Month 12 and Month 24|Full Analysis Set consists of only patients with triple LVMi values available at randomization, Month 12 and month 24 are included|||g/m^2.7||Standard Deviation|Mean
1418293|NCT01114529|Secondary|Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24|Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, or (3) death . *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted.|at 12 months and month 24 post-transplantation|Full Analysis Set|||Number of incidence|||Number
1418294|NCT01114529|Primary|Estimated Glomerular Filtration Rate (eGFR)|Assessment of renal function by comparing change from randomization to Month 12 in eGFR ‎‎(MDRD4) between treatment arms (Full analysis set). Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1‎|Month 12|Full Analysis set - observed eGFR values at month 12 (counted the patients with available values)|||mL/min/1.73m^2||Standard Deviation|Mean
1418295|NCT01114516|Secondary|Birthweight|Median birthweight|24 weeks||||grams||Inter-Quartile Range|Median
1418296|NCT01114516|Secondary|Neonatal Morbidity and Mortality|Days spent in the neonatal intensive care unit|1 year||||days||Inter-Quartile Range|Median
1418297|NCT01114516|Secondary|Gestational Age at Delivery|Median gestational age at delivery|24 weeks||||weeks||Inter-Quartile Range|Median
1418298|NCT01114516|Secondary|Gestational Latency of More Than 28 Days|The frequency of achieving a gestational latency of more than 28 days|28 days postpartum||||percentage of participants|||Number
1418299|NCT01114516|Primary|Gestational Latency Achieved Between Cerclage Placement and Time of Delivery|Median gestational latency achieved Between Cerclage Placement and Time of Delivery|24 weeks||||days||Inter-Quartile Range|Median
1418300|NCT01114503|Secondary|Assessment of Exploratory Biomarkers of Ribonucleic Acid (RNA) Transcription Analysis of Peripheral Blood|The exploratory biomarkers of RNA transcription analysis of peripheral blood was planned to be assessed on Day 1(pre dose), Week 4 and Week 24. The assessment was to be done using microarray and RNA expression using quantitative reverse transcription polymerase chain reaction (RT-PCR). This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418301|NCT01114503|Secondary|Assessment of Exploratory Biomarkers|The exploratory biomarkers were planned to be assessed on Day 1 (pre dose), Week 4, Week 12 and Week 24. It included assessment of peripheral blood mononuclear cells (PBMC) markers, suppression assays for the measure of effector cell proliferation, quantification of effector memory T-cells subsets, autoreactivity assays using cytokine production of supernatants and CFSE dilution, cytokine production by in-vitro stimulated T-cells, circulating serum biomarkers and may include subsequently discovered biomarkers of the biological response associated with GO or medically related conditions and/or the action of otelixizumab. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418302|NCT01114503|Secondary|Assessment of Circulating Cytokines of Interleukin 6 (IL6), IL10, Interferon Gamma (IFNγ) and Tumor Necrosis Factor Alpha (TNFα) up to 2 Weeks|Assessment of circulating cytokines of IL6, IL10, IFNγ and TNFα was planned to be assessed on Day 1-8 (pre dose) and Week 12. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 2|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418303|NCT01114503|Secondary|Assessment of Anti-otelixizumab Antibodies|Anti-otelixizumab antibodies were planned to be assessed on Day 1 (pre dose), Day 8 (pre dose), Week 4-24 and Month 12. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Month 12|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418304|NCT01114503|Secondary|Change From Baseline Measurement of Orbital Volume as Measured by Computed Tomography (CT) Scan|The assessment of orbital volume measured by CT scan was planned to be assessed on Week 12 and Week 24. Baseline was referred to assessment at Screening. Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Screening), Week 12 and Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418305|NCT01114503|Secondary|Change From Baseline for Participant-reported Health Related Quality of Life (QoL) Questionnaires of Short Form 36 ( SF-36) and Graves Ophthalmopathy (GO) QoL|Assessment of health related QoL was planned to be evaluated using the validated, disease specific, GO-QoL questionnaire and the SF-36 health survey questionnaire at Day 1 (pre dose) and Week 2- 24. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflected better outcomes. Baseline was referred to assessment on Day 1 (pre dose). Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Day 1, pre dose) to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418306|NCT01114503|Secondary|Change From Baseline for Individual Scores at Week 12 Incorporated in the European Group on Graves’ Orbitopathy (EUGOGO) Assessment Including, Eyelid Swelling, Clinical Activity Score (CAS) Score, Proptosis, Lid Width and Diplopia|The EUGOGO assessment of change was defined by improvement or deterioration of clinical scores. Improvement in EUGOGO was defined as improvement in two of the following measures in at least one eye, without deterioration in any of the same measures in both eyes: eyelid swelling according to color atlas evaluation, CAS by at least 2 points, proptosis by at least 2 millimeter (mm) by Hertel exophthalmometer, lid width by at least 2 mm, diplopia (disappearance or change in the degree) or improvement of >=8 degrees in motility unexplained by commensurate deterioration of motility of ipsilateral antagonists. Deterioration was defined by worsening by same quantity (as for improvement) of the same measures. Baseline was referred to assessment on Day 1 (pre dose). Change from Baseline was defined as post-Baseline value minus Baseline value. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Baseline (Day 1, pre dose) and Week 12|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418307|NCT01114503|Primary|Assessment of CD3/T-cell Receptor (TCR) Complex Saturation and Modulation|The assessment of CD3/TCR complex saturation and modulation was planned to be assessed on Day (1-8) pre dose, Week 2, Week 4, Week 8, Week 12 and Week 24. The extent of modulation was to be determined by the extent of TCR alpha beta (αβ) expression which was proportional to the combined levels of free CD3 sites and bound otelixizumab to CD4+ and CD8+ T cells. Bound levels of otelixizumab was planned to be determined by using flow cytometry method using an anti Immunoglobulin (Ig) antibody. The molecules of equivalent soluble fluorochrome (MESF) of the anti-Ig antibody was to be used to quantify the levels of bound otelixizumab present on T cells. Free otelixizumab binding sites (i.e., sites not occupied by otelixizumab administered to the participants) was to be detected by staining with fluorescein isothiocyanate (FITC) labelled otelixizumab. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418308|NCT01114503|Primary|Percentage of Circulating Peripheral T-cells, CD4+ and CD8+ Subset Counts|The lymphocyte subsets of T-cells, CD4+ and CD8+ cells were planned to be assessed at Day 1 (pre dose), Day 8 (pre dose), Week 2, Week 4, Week 8, Week 12 and Week 24. The percentages of relevant lymphocyte subsets was to be determined by flow cytometry. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418321|NCT01114438|Primary|HbA1c (%) Measured at Week 52||12 months|Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for analysis of HbA1c at the defined 12 month (week 52) endpoint.|||% glycated hemoglobin||Full Range|Median
1418309|NCT01114503|Primary|Individual Absolute Circulating Peripheral T Lymphocytes (T-cells), CD4+ and CD8+ Subset Counts|The lymphocyte subsets of T-cells, CD4+ and CD8+ cells were planned to be assessed at Day 1 (pre dose), Day 8 (pre dose), Week 2, Week 4, Week 8, Week 12 and Week 24. The absolute counts of the relevant lymphocyte subsets was to be determined by multiplying the percentages of the cell subsets with total lymphocyte counts. The percentages of relevant lymphocyte subsets was to be determined by flow cytometry. This endpoint was not analyzed due to the early termination of the study and since only 2 participants were recruited.|Up to Week 24|All Subjects Population. No participants were available for analysis because of early termination of study.||||||
1418310|NCT01114503|Primary|Number of Participants With an Epstein Barr Virus (EBV) Viral Load Abnormalities Meeting the Criteria for PCC|The PCC range for EBV viral load was > 10,000 copies of deoxyribonucleic acid (DNA) per million lymphocytes. The assessments were done at Week 2, Week 4, Week 8 and Week 12.|Week 2 to Week 12|All Subjects Population|||Participants|||Number
1418311|NCT01114503|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Meeting the Criteria for PCC|ECG parameters included pulse rate (PR) interval, QRS interval, QT interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval <110 and >220 milliseconds (msec); QRS interval <75 and >110 msec; QTc interval >480 to <= 500 msec, increase from baseline QTc >30 to <= 60 msec.|Screening (Day –35 to Day –1)|All Subjects Population|||Participants|||Number
1418312|NCT01114503|Primary|Number of Participants With Vital Signs Abnormalities Meeting the Criteria for PCC|Vital signs assessment included pulse rate, blood pressure, temperature and respiratory rate. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >110 beats per minute (bpm), >= 15 increase from baseline and >= 30 decrease from baseline; systolic blood pressure (SBP) < 85 and > 160 millimeters of mercury (mm Hg), >= 20 mmHg increase from baseline and >= 40 mmHg decrease from baseline; diastolic blood pressure (DBP) < 45 and > 100 mm Hg, >= 10 mmHg increase from baseline and >= 20 mmHg decrease from baseline.|Up to Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
1418313|NCT01114503|Primary|Number of Participants With Thyroid Function Assessment, Hormone and Glucose Assay Abnormalities Meeting the Criteria for PCC|The following laboratory parameters were analyzed: thyroid function assessment (thyroid stimulating hormone [TSH], thyroid peroxidase antibody, thyrotropin receptor antibodies (TSH-R-Abs) or TSH-binding inhibiting immunoglobulin (TBII), free thyroxine [fT4], free triiodothyronine [fT3]; hormone and glucose assays (cortisol, adrenocorticotrophic hormone [ACTH], insulin-like growth factor [IgF-1] and plasma glucose. Thyroid function tests were done at Day 1 (pre-dose) and Week 4-24. Hormone and glucose assays were done at Day 1 (pre-dose) and Week 2-24.|Up to Week 24|All Subjects Population|||Participants|||Number
1418314|NCT01114503|Primary|Number of Participants With Laboratory Urinalysis Abnormalities Meeting the Criteria for PCC|The urinalysis parameters included pH, glucose, protein, blood and ketones by dipstic and microscopy (if urine dipstick was positive for blood or protein). The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24.|Up to Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
1418315|NCT01114503|Primary|Number of Participants With Laboratory Hematology Abnormalities Meeting the Criteria for PCC|The PCC range for hematology parameters included white blood cell count, low- < 3 giga cells (GI)/L, high- > 20 GI/L; neutrophil count, low- < 1.5 GI/L; hemoglobin, low- > 25 g/L change from baseline, high- 180 g/L; hematocrit, low- > 0.075 L change from baseline, high- 0.54 L; platelet count, low- < 100 GI/L, high- >550 GI/L and lymphocytes, low < 0.8 GI/L. The assessments were done at Day 1 (pre dose), Day 8, Week 2-24, Month 12 and 24.|Upto Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
1418316|NCT01114503|Primary|Number of Participants With Laboratory Clinical Chemistry Abnormalities Meeting the Criteria for Potential Clinical Concern (PCC)|The PCC range for clinical chemistry parameters included albumin, <30 gram per liter (g/L); calcium, low- < 2.0 millimole (mmol)/L: high->2.75 mmol/L; creatinine, high- > 1.3x ULN mmol/L or > 159 micromole (μmol)/L or > 44 μmol/L change from Baseline; glucose, low- < 3.0 mmol/L, high- > 9.0 0 mmol/L; magnesium, low- < 0.5 mmol/L, high- > 1.23 mmol/L, phosphorus, low- < 0.8 mmol/L, high- > 1.6 mmol/L; potassium, Low- < 3.0 mmol/L, high- > 5.5 mmol/L; sodium, low- < 130 mmol/L, high- > 150 mmol/L; bicarbonate, low- < 18 mmol/L, high- > 32 mmol/L; alanine aminotransferase, high->= 2x ULN, where the normal range was (NR) 0 – 39 international units (IU)/L; aspartate aminotransferase, high- >= 2x ULN, where NR was 0 – 39 IU/L; alkaline phosphatase, high- >= 1.5x ULN, where NR was 35 – 120 IU/L; total bilirubin- >= 1.5x ULN, where NR was 0 – 18 μmol/L.The assessments were done at Day 1 (pre dose), Day 8, Week 2-24 and Month 12 and 24.|Up to Month 24 (Long term follow-up)|All Subjects Population|||Participants|||Number
1418317|NCT01114503|Primary|Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. The classification as potentially drug-related was done based on the investigator's judgment.|Up to Month 24 (Long term follow-up)|All Subjects Population included all participants who receive at least one dose of study medication.|||Participants|||Number
1418318|NCT01114438|Primary|Change From Baseline in SF 36v2 Quality of Life Assessment|Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.|Baseline, 12 months (explant), 6 months post explant (18 months post baseline)|The number of participants analyzed reflects all participants who received the implant and were assessed for QoL at the respective time points.|||units on a scale||Standard Deviation|Mean
1418322|NCT01114373|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||minutes||Standard Error|Mean
1418323|NCT01114373|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
1418324|NCT01114373|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
1418325|NCT01114373|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
1418326|NCT01114373|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
1418327|NCT01114373|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
1418328|NCT01114373|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
1418329|NCT01114373|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418330|NCT01114373|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418331|NCT01114373|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418332|NCT01114373|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is the number of pulsations of the heart per unit of time. It is measured in beats per minute (bpm). The ambulatory blood pressure monitor was used to calculate the heart rate. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
1418333|NCT01114373|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418334|NCT01114373|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418335|NCT01114373|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements are reported.|4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418336|NCT01114360|Secondary|Percentage of Participants With Melatonin-related Side Effect.||After 4 weeks of treatment|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||percentage of total number of patients|||Number
1418337|NCT01114360|Secondary|Nocturnal Dipping of Blood Pressure|Nocturnal dipping is the mean nighttime to mean daytime systolic and diastolic blood pressure ratios, or the percentage drop in nocturnal SBP compared to day time SBP. Night was defined as 10:00 PM through 5:59 AM. This ratio is calculated by the ambulatory blood pressure readings.|At the end of 4 weeks||||percentage ratio in night/day SBP||Standard Error|Mean
1418338|NCT01114360|Secondary|Total Sleep Time|The total sleep time will be measured by polysomnography (PSG) using an Embla polysomnograph. The nocturnal total sleep time (TST) or the the total number of minutes in any stage of sleep during the major nocturnal sleep period was measured by PSG.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||minutes||Standard Error|Mean
1418339|NCT01114360|Secondary|Plasma P-Selectin|P-Selectin is a marker of endothelial function. Levels of p-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
1418340|NCT01114360|Secondary|Plasma E-Selectin|E-Selectin is a marker of endothelial function. Levels of e-selectin were measured from stored plasma using enzyme-linked immunosorbent assay (ELISA).|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml||Standard Error|Mean
1418341|NCT01114360|Secondary|Urinary Adrenaline Excretion Rate|The rate of urinary adrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|40 patients were enrolled in the study. 4 subjects did not complete the study. 36 patients completed the study and were their own controls.|||ng/ml/min||Standard Error|Mean
1418342|NCT01114360|Secondary|Urinary Noradrenaline Excretion Rate|The rate of urinary noradrenaline excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
1418343|NCT01114360|Secondary|Urinary Dopamine Excretion Rate|The rate of urinary dopamine excretion was measured by the Enzyme-Linked Immunosorbent Assay (ELISA) method from urine samples collected overnight.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||ng/ml/min||Standard Error|Mean
1418344|NCT01114360|Primary|Mean Nighttime Diastolic Blood Pressure (DBP)|The nighttime diastolic blood pressure (DBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418345|NCT01114360|Secondary|Mean Daytime Heart Rate (HR)|Daytime heart rate is the number of the pulsations of the heart per unit of time during the day. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
1418346|NCT01114360|Secondary|Mean Daytime Mean Arterial Pressure (MAP)|Daytime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) during the day. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported.|At the end of 4 weeks|40 subjects enrolled the study. 4 subjects did not complete the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418347|NCT01114360|Secondary|Mean Daytime Diastolic Blood Pressure (DBP)|The daytime diastolic blood pressure was calculated as the average diastolic blood pressure during the daytime period based on 24 hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418348|NCT01114360|Secondary|Mean Daytime Systolic Blood Pressure (SBP)|The daytime systolic blood pressure was calculated as the average systolic blood pressure during daytime period based on 24hour ambulatory blood pressure monitoring. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418349|NCT01114360|Secondary|Mean Nighttime Heart Rate (HR)|Nighttime heart rate is number of pulsations of the heart per unit of time during nighttime sleep. It is measured in beats per minute (bpm). Ambulatory blood pressure monitoring was used to calculate the heart rate. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||beats per minute||Standard Error|Mean
1418350|NCT01114360|Secondary|Mean Nighttime Mean Arterial Pressure (MAP)|Nighttime mean arterial pressure (MAP) is the average blood pressure in the subject's arteries during one cardiac cycle (one complete heartbeat) at night. It is calculated using the formula, MAP = 1/3(SBP-DBP)+DBP; where SBP is the systolic blood pressure and DBP is the diastolic blood pressure. Means of multiple measurements were reported|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418351|NCT01114360|Primary|Mean Nighttime Systolic Blood Pressure (SBP)|The nighttime systolic blood pressure (SBP) was recorded using an ambulatory blood pressure (ABP) monitor. The measurements occurring from the onset of self-reported sleep to the end of self-reported sleep were recorded. Means of multiple measurements were reported.|At the end of 4 weeks|37 subjects enrolled the study. 1 subject did not complete the two arms of the study. 36 subjects completed the study in a crossover design, being their own controls.|||mmHg||Standard Error|Mean
1418401|NCT01113580|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The number of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.|||participants|||Number
1418352|NCT01114334|Secondary|Patient Health Questionnaire-9 Instrument for Assessing Depressive Symptoms|"Depressive symptoms were measured with the Patient Health Questionnaire-9 (PHQ-9) instrument. The PHQ-9 is a nine item survey to assess depressive symptoms over the previous 2 weeks. The patient may answer not at all (scored as a 0) , several days (scored as a 1), more than half the days (scored as a 2), or nearly every day (scored as a 3) for each item. The range in total scores is from 0 (no depressive symptoms or best outcome) to 27 (severe depressive symptoms or worst outcome). For this randomized trial mean total scores are reported."|36 weeks||||units on a scale||95% Confidence Interval|Mean
1418353|NCT01114334|Secondary|Adherence to Treatment With Antidepressant Medication|"Antidepressant Adherence will be measured with Computerized Pharmacy Records. Adherence will be operationalized as non-persistence, or time to discontinuation. Non-persistence will be considered to have occurred if the days of medication supply from the previous prescription plus a 30-day grace period exceed the number of days between the previous prescription date and the current prescription fill date. Filling no prescriptions, 'initiation failure,' will be treated as non-persistence. Minimally adequate persistence was defined as at least three 30-day fills of an antidepressant medication at a usual dose as defined in the American Psychiatric Association guideline without a 30-day gap in refills. The count of participants receiving minimally adequate persistence with antidepressant medication is reported for each study group."|36 weeks||||Participants|||Count of Participants
1418354|NCT01114334|Primary|Depression Remission|The primary outcome is depression remission ascertained with the Patient Health Questionnaire-9. A score of less than 5 is considered to represent remission. The secondary clinical outcome is the continuous measure of depressive symptoms.|36 weeks|We present clinical outcome (remission rate) at 36 weeks for all patient participants entering the study. 58 of 80 subjects assigned to Guideline-Based Medical Management, and 67 of 88 subjects assigned to Motivational Interview with Guideline-Based Medical Management had available data at 36 weeks (end of trial).|||participants|||Number
1418355|NCT01114217|Secondary|Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline|"Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis.~The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered."|TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||days||Inter-Quartile Range|Mean
1418356|NCT01114217|Secondary|Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol|"The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.~Mean change in FACIT-Fatigue questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as:~FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) – FACIT-Fatigue Score (Baseline).~TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course.~If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero."|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable FACIT-Fatigue Questionnaire data at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||units on a scale||Standard Deviation|Mean
1418357|NCT01114217|Secondary|Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol|Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for TSAT at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||percentage of saturation||Standard Deviation|Mean
1418358|NCT01114217|Secondary|Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol|Proportion of participants who achieved a hemoglobin level ≥12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|"ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.~Participants with no post-baseline hemoglobin values were classified as not achieving the increase.~Percentages are based on the number of participants in each course."|||percentage of participants|||Number
1418359|NCT01114217|Secondary|Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5|Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|"ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.~Participants with no post-baseline hemoglobin values were classified as not achieving the increase.~Percentages are based on the number of participants in each course."|||percentage of participants|||Number
1418455|NCT01112735|Secondary|Summary of Pain Assessment by Visit|Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 [no pain] to 10 [worst possible pain]) the patient experienced at the site of surgery at the time of the visit.|Day 3, 7, 14, 28, 60, 90|FAS|||Score on a Scale||Standard Deviation|Mean
1418360|NCT01114217|Secondary|Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course|"Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as:~Hemoglobin Change = Hemoglobin (TP Week 5) – Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered."|TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||g/dL||Standard Deviation|Mean
1418361|NCT01114217|Primary|Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol|"Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) – Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1.~Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit."|TP Baseline (Day 1), TP Week 5|ITT Population: Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.|||g/dL||Standard Deviation|Mean
1418362|NCT01114204|Secondary|Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline|The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.|From Baseline (Day 1) up to Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||days||Inter-Quartile Range|Mean
1418363|NCT01114204|Secondary|Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5|"The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.~Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as:~FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) – FACIT-Fatigue Score (Baseline).~Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||units on a scale||Standard Deviation|Mean
1418364|NCT01114204|Secondary|Mean Change In TSAT From Baseline To Week 5|"Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) – TSAT (Baseline).~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||percentage of saturation||Standard Deviation|Mean
1418365|NCT01114204|Secondary|Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5|"Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) – Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
1418366|NCT01114204|Secondary|Mean Change In Hemoglobin From Baseline To Week 5|"Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) – Hemoglobin (Baseline).~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||g/dL||Standard Deviation|Mean
1418367|NCT01114204|Primary|Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) – Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase.~Statistical analysis was performed for data up to Week 5 only."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
1424579|NCT01059760|Primary|Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed||Baseline and 3 days||||ng/mL||Standard Deviation|Mean
1418368|NCT01114139|Secondary|Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline|The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.|From Baseline (Day 1) up to Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||Days||Inter-Quartile Range|Mean
1418369|NCT01114139|Secondary|Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5|"The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.~Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as:~FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) – FACIT-Fatigue Score (Baseline).~Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||units on a scale||Standard Deviation|Mean
1418370|NCT01114139|Secondary|Mean Change In TSAT From Baseline To Week 5|"Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) – TSAT (Baseline).~TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||percentage of saturation||Standard Deviation|Mean
1418371|NCT01114139|Secondary|Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5|"Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) – Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
1418372|NCT01114139|Secondary|Mean Change In Hemoglobin From Baseline To Week 5|"Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as:~Hemoglobin Change = Hemoglobin (Week X) – Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||g/dL||Standard Deviation|Mean
1418373|NCT01114139|Primary|Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on:~Hemoglobin Change = Hemoglobin (Week X) – Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase.~Statistical analysis was performed for data up to Week 5 only."|Baseline (Day 1) through Week 5|ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or placebo) and was based upon randomized treatment assignment.|||Participants|||Count of Participants
1418374|NCT01113931|Secondary|Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured|Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28|Day 28|N. gonorrhoea Population. Only subjects with an evaluable outcome are included in the analysis.|||Percentage Participants Cured||95% Confidence Interval|Number
1418375|NCT01113931|Secondary|Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured|Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28|End of Study (Day 28)|M. genitalium Coinfected Population|||Percentage Participants Cured|||Number
1426028|NCT01044771|Primary|Patients With Reduced or Resolved Proteinuria|Measurement of Protein in Urine samples at end of study visit|24 weeks||||participants|||Number
1418376|NCT01113931|Secondary|Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured|Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28|End of Study (Day 28)|Clinically Evaluable Population|||Percentage Particpants Cured|||Number
1418377|NCT01113931|Primary|Microbiological Cure Rate|Percentage of Subjects in mITT Population with Microbiological Cure defined as a negative result for C. trachomatis as determined by GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test) at Day 28|Day 28|mITT Population - all randomized subjects who had positive NAAT for C. trachomatis at Baseline and took at least one dose of study drug.|||percentage of participants cured||95% Confidence Interval|Number
1418378|NCT01113801|Secondary|Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months|Analysis of covariance (ANCOVA) model was used with treatment as fixed effects, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) ) log transformed (ln) as covariates.|Baseline through 12 months|All randomized participants who received at least 1 dose of drug.|||mL/min/1.73 m²/month||Standard Error|Least Squares Mean
1418379|NCT01113801|Secondary|Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months|Analysis of covariance (ANCOVA) model was used with treatment as fixed effects and baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.|Baseline through 12 months|All randomized participants who received at least 1 dose of drug.|||ln milligrams per deciliter(mg/dL)/month||Standard Error|Least Squares Mean
1418380|NCT01113801|Secondary|Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration –Time Curve (AUC ) Over a Dosing Interval||Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)|All randomized participants who received at least 1 dose of drug and had evaluable PK data.|||microgram*hour per milliliter(µg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1418381|NCT01113801|Secondary|Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint|Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.|Baseline, 12 months|All randomized participants who received at least 1 dose of drug and had evaluable urine protein and creatinine ratio values.|||ln grams/grams [ln( g/g)]||Standard Error|Least Squares Mean
1418382|NCT01113801|Primary|Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint|Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.|Baseline, 12 months|All randomized participants who received at least 1 dose of drug and had evaluable baseline and post baseline serum creatinine values.|||ln milligrams per deciliter [ln(mg/dL)]||Standard Error|Least Squares Mean
1418383|NCT01113749|Post-Hoc|Percentage of Subjects With Weight Loss|Percentage of subjects with weight loss at 9 months|9 months|intention to treat|||percentage of participants|||Number
1418384|NCT01113749|Secondary|Percent With Treatment Decisions|Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding.|3 months||||percentage of subjects|||Number
1418385|NCT01113749|Primary|Decisional Conflict Scale|Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.|3 months|intention to treat|||units on a scale||95% Confidence Interval|Mean
1418386|NCT01113723|Primary|Time to Confirm the Placement of the Tracheal Tube|It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform|up tp 3 minutes||||Seconds||Standard Deviation|Mean
1418387|NCT01113723|Primary|Intubation Time (Seconds)|Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube|3 minutes||||Seconds||Standard Deviation|Mean
1418388|NCT01113723|Secondary|Time to Obtain Glottis Visualization (Seconds)|Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine.|1 minute|Time to Obtain Glottis Visualization (Seconds) Glottic visualization during the beginning of the intubation procedure.|||Seconds||Standard Deviation|Mean
1418389|NCT01113710|Secondary|Daytime Tiredness|"Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 561 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
1418402|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||Percentage of participants||95% Confidence Interval|Number
1418482|NCT01112579|Primary|Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.||Baseline and 6 months||||mL/m2||Standard Deviation|Mean
1418390|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime in Activity|"Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
1418391|NCT01113710|Secondary|Severity of Restless Legs Syndrome (RLS) at Daytime at Rest|"Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 562 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
1418392|NCT01113710|Secondary|Satisfaction With Sleep|"Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
1418393|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) During the Night|"Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
1418394|NCT01113710|Primary|Severity of Restless Legs Syndrome (RLS) at Bedtime|"Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale).~The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.~The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities)."|From Baseline to end of Observation Period (3 months).|"Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once & for whom valid scores for item 2 & item 3 of the RLS-6 scale at baseline & at least one valid post baseline score for both item 2 & item 3 of the RLS-6 scale is documented."|||units on a scale||Standard Deviation|Mean
1418395|NCT01113632|Secondary|Safety of the Treatment Regimen|Listing of all non-serious Adverse Events ocurring in 5% of patients or more|18 Months||||participants|||Number
1418396|NCT01113632|Secondary|Number of Partial Responses|The Number of Patients Who Experience a Partial Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions|18 Months|All patients who were evaluable for a response assessment|||participants|||Number
1418397|NCT01113632|Secondary|Number of Complete Responses|The Number of Patients Who Experience a Complete Response From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions|18 Months|All patients who were evaluable for a response assessment|||participants|||Number
1418398|NCT01113632|Primary|Overall Response Rate (ORR)|The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|All patients who were evaluable for a response assessment|||participants|||Number
1418399|NCT01113632|Secondary|Progression-free Survival (PFS)|To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.|18 months||||months||95% Confidence Interval|Median
1418400|NCT01113580|Secondary|Frequency and Intensity of Any Unsolicited Adverse Events|"Unsolicited adverse event (UAE) grading:~Mild: Symptoms were easily tolerated and there was no interference with daily activities. Moderate: Enough discomfort to have caused some interference with daily activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine and provided follow-up safety data.|||participants|||Number
1418403|NCT01113580|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||Fold increase||95% Confidence Interval|Number
1418404|NCT01113580|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||Percentage of participants||95% Confidence Interval|Number
1418405|NCT01113541|Secondary|Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline, Week 1 through Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||participants|||Number
1418406|NCT01113541|Secondary|Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale|31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
1418407|NCT01113541|Secondary|Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on scale||95% Confidence Interval|Mean
1418408|NCT01113541|Secondary|Change From Baseline in EuroQoL Index (EQ-I)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on scale||95% Confidence Interval|Mean
1418409|NCT01113541|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)|0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on scale||Standard Deviation|Mean
1418410|NCT01113541|Secondary|Change From Baseline in Drug Attitude Inventory (DAI)|DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.|Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
1418411|NCT01113541|Secondary|Clinical Global Impression - Improvement (CGI-I) Subscale Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
1418412|NCT01113541|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
1418483|NCT01112514|Primary|Number of Neoplastic Lesions Detected||upto 15 mins||||Lesions|||Number
1418413|NCT01113541|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS)|11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale|||Number
1418414|NCT01113541|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
1418415|NCT01113541|Secondary|Change From Baseline in Physical Activity Index|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.|Baseline, Week 28, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||units on a scale|||Number
1418416|NCT01113541|Secondary|Change From Baseline in Leptin||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||nanograms per milliliter||Standard Deviation|Mean
1418417|NCT01113541|Secondary|Change From Baseline in Apolipoprotein B (ApoB) Levels||Baseline, Week 52 or Early Termination|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||milligrams per deciliter||Standard Deviation|Mean
1418418|NCT01113541|Secondary|Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.|Baseline, Week 4, Week 52 or Early Termination|PP and ITT; n = number of participants with analyzable data at observation.|||milliseconds||Standard Deviation|Mean
1418419|NCT01113541|Secondary|Change From Baseline in Insulin Levels||Baseline, Week 52 or Early Termination|PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study.|||international units per milliliter||Full Range|Median
1418420|NCT01113541|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag.|||percent HbA1c||Full Range|Median
1418421|NCT01113541|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index = weight in kilograms (kg) / height in meters (m)^2 .|Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study.|||kg/m^2||Standard Deviation|Mean
1418422|NCT01113541|Secondary|Change From Baseline in Weight||Baseline, Week 4, Week 12, Week 52 or Early Termination|PP and ITT; n = number of participants with evaluable data at observation.|||kilograms||Standard Deviation|Mean
1418423|NCT01113541|Secondary|Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels||Baseline, Week 52 or Early Termination|PP and ITT. Median was reported due to small sample size and risk of skewing.|||milligrams per deciliter||Full Range|Median
1418424|NCT01113541|Secondary|Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).|Baseline, Week 4, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||scores on a scale||Standard Deviation|Mean
1418425|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides|MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimoles per liter||Standard Deviation|Mean
1418426|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)|MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimoles per liter||Standard Deviation|Mean
1418427|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose|MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimoles per liter||Standard Deviation|Mean
1418428|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure|MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||millimeters of mercury||Standard Deviation|Mean
1418429|NCT01113541|Secondary|Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference|MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).|Baseline, Week 4, Week 12, Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||centimeters||Standard Deviation|Mean
1418430|NCT01113541|Secondary|Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors|MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||percentage of participants|||Number
1418431|NCT01113541|Secondary|Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||percentage of participants|||Number
1418432|NCT01113541|Secondary|Metabolic Syndrome (MS) Prevalence|Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline through Week 52|PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||percentage of participants|||Number
1418433|NCT01113541|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.|Baseline, Week 52|PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study.|||risk factors||Standard Deviation|Mean
1418434|NCT01113541|Primary|Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation|MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.|Week 52 or Early Termination|Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation.|||percentage of participants|||Number
1418435|NCT01113463|Secondary|Number of Participants by Response Criteria|Complete Response (CR): Complete disappearance all measurable & evaluable disease. No new lesions or evidence of non-evaluable disease. Partial Response (PR): >/= 50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, nor new lesions. Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 12 weeks duration. Progression: 25% increase in sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Unknown: Progression not been documented & one or more measurable or evaluable sites have not been assessed.|Response obtained between days 15 and 21 of every even cycle and/or when clinically indicated, up to 6 months (approximately 9 completed cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.|||participants|||Number
1418436|NCT01113463|Primary|Progression-Free Survival (PFS) at 6 Months|"PFS defined as number of participants alive without documented evidence of disease progression (progression free) at 6 months. Progression-free survival calculated from the date of Day 1 Cycle 1 to the date that criteria for progression of disease is first seen. Progression is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|6 months (following nine 21-day cycles)|Intent to treat population included all eligible subjects who received at least one dose of study drug.|||participants|||Number
1418437|NCT01113398|Secondary|Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities|The percentage of participants who experience unacceptable toxicity, defined as any treatment-related grade 2 or greater CNS hemorrhage or grade 4 or greater non-hematologic toxicity, will be calculated.|2 years|Intent-to-treat|||percentage of participants|||Number
1418438|NCT01113398|Secondary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1418440|NCT01113398|Primary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.|2 years|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1418441|NCT01113385|Secondary|Number of Participants Achieving Complete or Partial Remission at 16 Weeks|Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16. Complete remission is defined as (Urine Protein:Creatinine ratio [UPC] <0.2 g/g). Partial remission is defined as UPC 0.2-2 g/g.|16 weeks||||participants in remission at 16 weeks|||Number
1418442|NCT01113385|Primary|Focal Segmental Glomerulosclerosis Permeability Factor (FSPF)|FSPF is reported in relation to its induction of glomerular albumin permeability (Palb) of isolated glomeruli on a range from 0 to 1, with 0 indicative of normal glomeruli and 1 indicative of injury to the permeability barrier. Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16: Reduction in FSPF to <0.5 Palb or decrease in FSPF by > 0.3 Palb.|16 weeks||||Palb||Standard Deviation|Mean
1418443|NCT01113008|Secondary|Cardiovascular Mortality||12 month||||participants|||Number
1418444|NCT01113008|Secondary|Readmission Due to Acute Coronary Syndrome||12 month||||participants|||Number
1418445|NCT01113008|Primary|Maximum Increase of Troponin at 24 Hours||24 hours||||ng/ml||95% Confidence Interval|Mean
1418446|NCT01112917|Secondary|Major Device-Related Adverse Events in Converted Subjects||6-months|There was one subject (007-006) excluded as no 6-month images were available although a 6-month assessment was conducted.|||participants|||Number
1418447|NCT01112917|Primary|Technical Success|Technical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs. Further, in the analysis of the data, the sponsor did not count any filters as a ‘technically’ successful conversion when the operator was unable to snare the filter hook during an attempted conversion.|6-months||||participants|||Number
1418448|NCT01112865|Secondary|Ease of Use of Each Injection Pen|Participants were asked the following question from Section I of the IPAQ PRO tool, “Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?” Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1).|Month 2 and Month 4|FAS; Number of participants analyzed (N) = participants with evaluable data|||scores on a scale||Standard Deviation|Mean
1418449|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen|"Investigators were asked the following study treatment continuation question, Which device did the participant choose for continued treatment? Choices included the Genotropin® Pen or the new injection pen."|Month 4|FAS subset of participants located in areas where the new device was available.|||percentage of dyads, adult participants||95% Confidence Interval|Number
1418450|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS|||percentage of dyads, adult participants||95% Confidence Interval|Number
1418451|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|FAS; Number of participants analyzed (N)= participants with evaluable data|||percentage of dyads, adult participants||95% Confidence Interval|Number
1418452|NCT01112865|Secondary|Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the IPAQ PRO tool, Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall. Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference."|Month 4|FAS|||percentage of dyads, adult participants||95% Confidence Interval|Number
1418453|NCT01112865|Primary|Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®|"Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall? Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference."|Month 4|Full Analysis Set (FAS): randomized participants who used a study pen at least once to administer somatropin; Number of participants analyzed (N)= participants with evaluable data. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).|||percentage of dyads, adult participants||95% Confidence Interval|Number
1418454|NCT01112735|Secondary|Summary of Numbness Assessment by Visit|Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 [no numbness] to 10 [complete numbness]) that the patient experienced at the time of the visit.|Day 3, 7, 14, 28, 60, 90|FAS|||Score on a Scale||Standard Deviation|Mean
1418484|NCT01112358|Secondary|Number of Participants in Whom At Least 1 Stimulation Cycle Was Cancelled||Randomization to Day 8|ITT population|||Participants|||Number
1418456|NCT01112735|Secondary|Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus|Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.|Days 0 (Baseline), 3, 7, 14, 28, 60, 90|FAS|||Score on a Scale||Standard Deviation|Mean
1418457|NCT01112735|Secondary|Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus|"Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand & Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO:~ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO."|Days 0 (Baseline), 3, 7, 14, 28, 60, 90|FAS|||Units on a Scale||Standard Deviation|Mean
1418458|NCT01112735|Secondary|Total Volume of Fluid Aspirations for Seromas|Volume of fluid recovered was recorded.|Day 0 (Surgery Day) to Day 90|FAS|||mL||Standard Deviation|Mean
1418459|NCT01112735|Secondary|Number of Fluid Aspiration for Seromas|Number of interventions recorded.|Day 0 (Surgery Day) to Day 90|FAS|||Interventions||Standard Deviation|Mean
1418460|NCT01112735|Secondary|Time to Drain Removal|The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30cc.|Day 0 (Surgery Day) up to Day 90|FAS|||Days||Standard Deviation|Mean
1418461|NCT01112735|Secondary|Occurrence of Hematoma|The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel.|Day 0 (Surgery Day) to Day 90|FAS|||Events|||Number
1418462|NCT01112735|Secondary|Occurrence of Seroma|The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.|Day 0 (Surgery Day) to Day 90|FAS|||Events|||Number
1418463|NCT01112735|Primary|Total Drainage Volume Collected Until Drain Removal|Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was <=30 cc.|Day 0 (Surgery Day) to Day 90|Full Analysis Set (FAS) consists of all subjects who were randomized (ie, the investigator opened the randomization envelope) and treated and who had an available assessment for the primary efficacy endpoint.|||mL||Standard Deviation|Mean
1418464|NCT01112696|Secondary|Device Related Moderate or Device Related Severe Adverse Events|"Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy.~Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment.~Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device."|days one through six of sensor wear||||Participants|||Count of Participants
1418465|NCT01112696|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|98 subjects of 100 enrolled subjects (a total of 5857 paired sensor and YSI readings) completed participation in the inpatient frequent blood sampling procedure.|||paired sensor and YSI glucose readings|paired YSI/sensor glucose values|95% Confidence Interval|Number
1418466|NCT01112683|Secondary|Changes of Safety and Tolerability Assessments at Baseline and End of Study|Clinical history and physical examinations, electrocardiograms (ECGs), comprehensive clinical laboratory tests, and incidence of adverse event recording. The comprehensive clinical laboratory tests will include assessments of liver and kidney function, electrolytes, acid/base balance, and blood glucose and proteins. In addition, pregnancy tests will be performed on all female participants of childbearing potential.|Safety and tolerability assessments will be performed at three time points: 1) 1-7 days before beginning of treatment; 2) after 8 weeks from the beginning of the treatment; and 3) 16-17 weeks from the beginning of the treatment||||participants|||Number
1418485|NCT01112358|Secondary|Plasma Levels of LH||At the time of r-hCG administration (any days between Day 2 to Day 8)|ITT population|||IU per liter (IU/L)||Standard Deviation|Mean
1418486|NCT01112358|Secondary|rFSH Cumulative Dose||Randomization to Day 8|ITT population|||IU||Standard Deviation|Mean
1418487|NCT01112358|Secondary|Duration of Ovarian Stimulation|Duration of ovarian stimulation was defined as the time from start of study treatment to time of r-hCG administration.|Randomization to Day 8|ITT population|||days||Standard Deviation|Mean
1418488|NCT01112358|Secondary|Endometrial Thickness||At the time of r-hCG administration (any days between Day 2 to Day 8)|ITT population|||millimeters (mm)||Standard Deviation|Mean
1418489|NCT01112358|Secondary|Plasma Level of Estradiol||At the time of r-hCG administration (any days between Day 2 to Day 8)|ITT population|||Picograms per milliliters (pg/mL)||Standard Deviation|Mean
1418467|NCT01112683|Secondary|Changes in Benchmark Neuropsychological Measures From Baseline to End of Study|"The neuropsychological benchmark measures assessed in this study are~Peabody Picture Vocabulary Test-III (PPVT-III; range: -27.00 to 23.00)~Test for the Reception of Grammar (TROG; range: -13.00 to 19.00)~Verbal Fluency (from the Developmental Neuropsychological Assessment (NEPSY); range: -13.00 to 10.00)~Recall of Digits (Differential Ability Scales; DAS; -50.00 to 59.00)~Spatial working memory (SWM; part of the Cambridge Neuropsychological Test Automated Battery, or CANTAB; range: -9.00 to 8.00)~Scales of Independent Behavior Revised (SIB-R; -12.00 to 26.00) All listed values represent differences in scores obtained at baseline subtracted from scores at 16-weeks of treatment. With the exception of the spatial working memory, for all measures, higher values represent better outcome. For the spatial working memory, lower values represent better outcome."|Benchmark neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|These measures were not predicted to change due to memantine treatment. Measures of non-verbal reasoning, receptive language and vocabulary, short-term phonological memory, verbal and non-verbal working memory and adaptive/behavioral functioning were included.|||scores on a scale||90% Confidence Interval|Mean
1418468|NCT01112683|Primary|Changes in Neuropsychological Measures From Baseline to End of Study|"The hippocampus-dependent measures assessed in the present study are~Pattern recognition memory* - Measures visual memory for non-namable designs; scale range in dataset 4-24; higher score indicates better performance~Paired associates task* - Measures ability to learn visual associations between a picture and its location, and retention of this information over time; scale range in dataset 0-17; higher score indicates better performance~California Verbal Learning Test (CVLT) — Children's Version** - Measures episodic verbal memory (sum of the items recalled over the 4 learning trials); scale range in dataset 0-35; higher score indicates better performance~Rivermead Behavioral Memory Test-Children's version** - Measures episodic memory for visual information presented in context; scale range in dataset 1-20; higher score indicates better performance * used in power analysis calculation of sample size ** secondary measures associated with the primary hypothesis"|These neuropsychological measures will be assessed one time 24 hours before the beginning of treatment and then a second time 16 weeks from the beginning of the treatment|One participant dropped out of the study due to parent complaints of increased anxiety, and another was excluded from analyses due to side effects (increased and persistent anxiety) reported at study completion.|||units on a scale||90% Confidence Interval|Mean
1418469|NCT01112670|Other Pre-specified|Atorvastatin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng/ml||Standard Deviation|Mean
1418470|NCT01112670|Other Pre-specified|Atorvastatin Area Under the Plasma Concentration Time Curve (AUC) Over the Dosing Interval (0-24 Hours)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng*h/ml||Standard Deviation|Mean
1418471|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Renal Clearance (CLr)|CLr of sitagliptin when administered with atorvastatin divided by CLr of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.|||ratio||95% Confidence Interval|Mean
1418472|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.|||ml/min||Standard Deviation|Mean
1418473|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Renal Clearance (CLr)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study and who had complete urine data.|||ml/min||Standard Deviation|Mean
1418474|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Maximum Plasma Concentration (Cmax)|Cmax of sitagliptin when administered with atorvastatin divided by Cmax of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ratio||95% Confidence Interval|Mean
1418475|NCT01112670|Other Pre-specified|Relative Change in Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity|AUC of sitagliptin when administered with atorvastatin divided by AUC of sitagliptin when administered alone|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ratio||95% Confidence Interval|Mean
1418476|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng/ml||Standard Deviation|Mean
1418477|NCT01112670|Secondary|Sitagliptin + Atorvastatin: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng*h/ml||Standard Deviation|Mean
1418478|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Maximum Plasma Concentration (Cmax)||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng/ml||Standard Deviation|Mean
1418479|NCT01112670|Primary|Sitagliptin Monotherapy: Sitagliptin Area Under the Plasma Concentration-time Curve (AUC) From 0 to Infinity||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 hours post-dose|The population analyzed included participants who completed both periods of the pharmacokinetic crossover study.|||ng*hr/ml||Standard Deviation|Mean
1418480|NCT01112579|Secondary|Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months||||mL/kg/min||Standard Deviation|Mean
1418481|NCT01112579|Secondary|Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months||Baseline and 6 Months||||pg/mL||Standard Deviation|Mean
1426157|NCT01043094|Primary|Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))|Area under the curve from start to elimination for Pitavastatin.|48 hours||||nanogram hour per milliliter (ng•h/mL)||Standard Deviation|Mean
1418490|NCT01112358|Secondary|Implementation Rate|Implementation rate (clinical pregnancy/embryo transferred) was defined as the number of clinical pregnancies divided by number of embryos transferred.|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Clinical pregnancy/embryo transferred||95% Confidence Interval|Number
1418491|NCT01112358|Secondary|Number of Participants With Clinical Pregnancy|A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or heartbeat (fetal sac).|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Participants|||Number
1418492|NCT01112358|Secondary|Number of Participants With Positive Pregnancy Test|The beta Human Chorionic Gonadotropin (beta-hCG) test was used as pregnancy test.|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Participants|||Number
1418493|NCT01112358|Secondary|Number of Embryos Transferred by In Vitro Fertilization (IVF)||Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Embroys||Standard Deviation|Mean
1418494|NCT01112358|Secondary|Number of Embryos by Quality|Embryo quality was graded according to morphological classification of Veeck. Grade 1: even blastomeres with no fragmentation; Grade 2: even blastomeres with slight fragmentation (less than 20%); Grade 3: uneven size blastomeres with no fragmentation; Grade 4: even or uneven size blastomeres with moderate fragmentation (20-25%); and Grade 5: unrecognizable blastomeres with severe fragmentation (>50%).|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||Embroys||Standard Deviation|Mean
1418495|NCT01112358|Secondary|Fertilization Rate|The fertilization rate (2 pronuclei [PN] fertilized oocytes per inseminated oocyte) was defined as number of 2 PN fertilized oocytes divided by number of inseminated oocytes.|Up to 35-45 days after administration of r-hCG (r-hCG administration = Day 2 to Day 8)|ITT population|||2PN fertilized oocyte/inseminated oocyte||Standard Deviation|Mean
1418496|NCT01112358|Secondary|Oocyte Nuclear Maturity Rate|Oocyte nuclear maturity rate (metaphase II oocytes per retrieved oocyte) is defined as number of metaphase II oocytes divided by total number of oocytes retrieved.|At the end of stimulation (Day 2 up to Day 8)|ITT population|||metaphase II oocytes/retrieved oocyte||Standard Deviation|Mean
1418497|NCT01112358|Primary|Oocytes Recovery Rate|Oocytes recovery rate (oocytes per >14 mm follicle) is defined as number of oocytes retrieved divided by number of follicles >14 mm in diameter.|At the end of stimulation (Day 2 up to Day 8)|ITT population|||oocytes per >14 mm follicle||Standard Deviation|Mean
1418498|NCT01112358|Primary|Number of Follicles Greater Than (>) 14 Millimeter (mm) in Diameter||At the end of stimulation (Day 2 up to Day 8)|ITT population|||Follicles||Standard Deviation|Mean
1418499|NCT01112358|Primary|Number of Oocytes Retrieved||At the end of stimulation (Day 2 up to Day 8)|ITT population|||Oocytes||Standard Deviation|Mean
1418500|NCT01112267|Secondary|Percentage of Participants With Participants' Global Assessment on Investigational Product|"Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1418501|NCT01112267|Secondary|Percentage of Participants With Investigator's Global Assessment on Investigational Product|"Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here."|Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint. Here ‘N’ signifies those participants who were evaluated for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1418502|NCT01112267|Secondary|Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29|The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability.|Baseline and Day 29|FAS population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Unit on a scale||Standard Deviation|Mean
1418503|NCT01112267|Secondary|Change From Baseline in Short Form (SF)-36 Score at Day 29|"The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in Reported (Rptd.) Health Transition domain higher score indicates worse quality of life."|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Unit on a scale||Standard Deviation|Mean
1418504|NCT01112267|Secondary|Percentage of Participants With Pain Relief|Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success.|Day 8, Day 15 and Day 29|the FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Percentage of participants||95% Confidence Interval|Number
1418505|NCT01112267|Primary|Change From Baseline in Pain Intensity at Day 29|Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline and Day 29|The FAS population included all the participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Unit on a scale||Standard Deviation|Mean
1418506|NCT01112267|Primary|Percentage of Participants With Reduction in Pain Intensity|The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain.|Baseline up to Day 29|Full analysis set (FAS) population included all participants who had received investigational product and had at least 1 data of measurement of primary efficacy endpoint.|||Percentage of Participants||95% Confidence Interval|Number
1418507|NCT01112241|Primary|Absolute Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC (L), before bronchodilators - FRC (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute negative change (liters)||Standard Deviation|Mean
1418508|NCT01112241|Primary|Per Cent Change of Functional Residual Capacity (FRC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FRC decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [FRC, expressed in liters (L), before bronchodilators - FRC (L) after bronchodilators/FRC (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent negative change||Standard Deviation|Mean
1418509|NCT01112241|Primary|Absolute Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥0.30 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV (L), before bronchodilators - RV (L) after bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute negative change (liters)||Standard Deviation|Mean
1418510|NCT01112241|Primary|Per Cent Change of Residual Volume (RV) After Bronchodilators|Following albuterol plus tiotropium inhalation, RV decrements ≥10 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to O'Donnell et al. [Eur Respir J 2001; 18: 914-920]. They were calculated as follows: [RV, expressed in liters (L), before bronchodilators - RV (L) after bronchodilators/RV (L) after bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent negative change||Standard Deviation|Mean
1418511|NCT01112241|Primary|Per Cent Change of Partial Forced Expiratory Flow (V'Part) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'part increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'part, expressed in liters.second-1 (L.s-1), after bronchodilators - V'part (L.s-1) before bronchodilators/V'part (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
1418512|NCT01112241|Primary|Per Cent Change of Instantaneous Maximal Forced Expiratory Flow (V'Max) After Bronchodilators|Following albuterol plus tiotropium inhalation, V'max increments ≥40 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to Pellegrino et al. [Chest 1998; 114:1607-1612]. They were calculated as follows: [V'max, expressed in liters.second-1 (L.s-1), after bronchodilators - V'max (L.s-1) before bronchodilators/V'max (L.s-1) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following HSCT for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
1418559|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio (INRmax)|Peak international normalised ratio for warfarin, measured as the maximum INR over time.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||Ratio||95% Confidence Interval|Geometric Mean
1426113|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 42||||percentage of donor cells||Standard Deviation|Mean
1418513|NCT01112241|Primary|Absolute Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥0.20 liters (L) compared with baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC (L) after bronchodilators - FVC (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute positive change (liters)||Standard Deviation|Mean
1418514|NCT01112241|Primary|Per Cent Change of Forced Vital Capacity (FVC) After Bronchodilators|Following albuterol plus tiotropium inhalation, FVC increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FVC, expressed in liters (L), after bronchodilators - FVC (L) before bronchodilators/FVC (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
1418515|NCT01112241|Primary|Absolute Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥0.20 liters (L) as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1 (L) after bronchodilators - FEV1 (L) before bronchodilators].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||absolute positive change (liters)||Standard Deviation|Mean
1418516|NCT01112241|Primary|Per Cent Change of Forced Expiratory Volume in 1 Second (FEV1) After Bronchodilators|Following albuterol plus tiotropium inhalation, FEV1 increments ≥12 per cent as compared to baseline, in an individual subject, were considered as evidence of response to bronchodilators, according to the American Thoracic Society-European Respiratory Society standard criteria [Pellegrino et al. Eur Respir J 2005; 26: 948-968]. They were calculated as follows: [FEV1, expressed in liters (L), after bronchodilators - FEV1 (L) before bronchodilators/FEV1 (L) before bronchodilators x 100].|Baseline and 90 min after bronchodilators|Seventeen consecutive, clinically-stable, Caucasian outpatients, presenting with mild-to-very-severe obliterative bronchiolitis following hematopoietic stem cell transplantation (HSCT) for hematological malignancies, were studied. They were diagnosed from 460 patients (253 males, 207 females) undergoing HSCT (sourcing from bone marrow).|||per cent positive change||Standard Deviation|Mean
1418517|NCT01112059|Secondary|Mean Change in Pulmonary Function Over Treatment Duration|Observe change in FEV1% predicted from beginning to end of study|Baseline to end of inpatient clinical exacerbation (average 14 days)||||Percentage of predicted FEV1||Standard Deviation|Mean
1418518|NCT01112059|Secondary|Mean Sputum Matrix Metalloprotease-9 (MMP-9) Activity End of Treatment|Measurement of endogenous active matrix metalloprotease-9 (MMP-9) in the sputum|8 days||||ng/mg total protein||Standard Deviation|Mean
1418519|NCT01112059|Primary|Matrix Metalloprotease-9 (MMP-9) Protein Levels in Sputum|Mean sputum matrix metalloprotease-9 (MMP-9) levels measured at the end of therapy|8 days past baseline||||ng/mg total protein||Standard Deviation|Mean
1418520|NCT01112059|Primary|Number of Adverse Events|Examines tolerability and safety with focus on adverse events (AEs) and serious adverse events (SAEs)|1 month from enrollment||||adverse events|||Number
1418521|NCT01111851|Secondary|Brain NK1-receptor Occupancy at 120 Hours Post Dose||120 hours post dose|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
1418522|NCT01111851|Secondary|Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)||30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
1418523|NCT01111851|Primary|Brain NK1-receptor Occupancy at 48 Hours Post Dose||48 hours post dose|"All participants with at least 1 successful postdose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
1418524|NCT01111851|Primary|Brain NK1-receptor Occupancy at 24 Hours Post Dose||24 hours post dose|"All participants with at least 1 successful post dose PET~scan were included in the analysis population."|||Percent of occupancy||95% Confidence Interval|Geometric Mean
1418525|NCT01111838|Primary|To Determine Overall Objective Response.|Patients with measurable disease will be evaluated using RECIST criteria for determination of response.|every 8 weeks||||participants|||Number
1418526|NCT01111825|Secondary|Overall Survival (OS)|Defined as the time from enrollment to death due to any cause; censored at the date last known alive.|From enrollment to date of death from any cause, or end of long term follow-up, assessed up to three years.|ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||months||95% Confidence Interval|Median
1418527|NCT01111825|Secondary|Progression-free Survival (PFS)|Defined as time from date of enrollment until the first disease recurrence or progression or death due to any cause; censored at the last assessable evaluation or at the initiation of new anti-cancer therapy. Disease assessment is based on investigator tumor assessments. If no post-baseline tumor assessment then censored at enrollment date.|From date of enrollment until the date of first documented progression, or date of death from any cause, whichever came first, assessed up to two years.|ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||months||95% Confidence Interval|Median
1418528|NCT01111825|Secondary|Duration of Response (DOR)|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, Progressive Disease (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and/or the appearance of one or more new lesions.|From first response to first PD or death, assessed up to two years.|"Patients who were enrolled and responded in the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.~Note, no subject in Phase II triple negative cohort had a response. Therefore, no participants were analyzed for DOR."|||Participants|||Count of Participants
1418529|NCT01111825|Secondary|Clinical Benefit Rate (CBR)|"Defined as the proportion of patients who achieved objective response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.~Clinical Benefit (CB) = CR + PR + SD >= 24 weeks."|From enrollment date to first documented response, or last tumor assessment, assessed up to two years|ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||Participants|||Count of Participants
1418530|NCT01111825|Primary|Objective Response Rate (ORR) (Phase II)|"ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met."|From enrollment date to first documented response, or last tumor assessment, assessed up to two years|ITT population (all enrolled subjects) for the Phase II portion of the study. Per protocol, Phase I data was not included in efficacy analysis.|||Participants|||Count of Participants
1418531|NCT01111526|Secondary|Occurrence of Possibly Related Adverse Events|Number of participants with adverse events possibly related to study treatment, per event category.|5 years, 3 months|All participants|||participants|||Number
1418532|NCT01111526|Secondary|Stable or Improved Chronic GVHD Severity Score|Stable or improved Chronic GVHD score: Improved Mild to None; Improved Severe to Moderate; Improved Moderate to None, Remained Stable at Mild.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at 1 year.|||participants|||Number
1418533|NCT01111526|Secondary|Chronic GVHD Severity at MTD|Chronic GVHD maximum severity grade at MTD, in participants without overlap syndrome at initiation of study therapy. Maximum c-GVHD severity: Mild, Moderate, Severe.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks, had overlap syndrome at MTD and were evaluable at time of analysis.|||participants|||Number
1418534|NCT01111526|Secondary|Chronic GVHD Onset|Chronic GVHD onset in participants without overlap syndrome at initiation of study therapy. Number of participants with overlap syndrome at MTD.|Up to 1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.|||participants|||Number
1418535|NCT01111526|Secondary|Occurrence of Discontinuation of All Immune Suppression|Number of participants discontinuing all immune suppression without subsequent flare by 1 year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks and were evaluable at 365 days.|||participants|||Number
1418536|NCT01111526|Secondary|Overall Survival (OS)|Overall Survival (OS) at one year post initiation of therapy.|1 year|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.|||participants|||Number
1418537|NCT01111526|Secondary|Incidence of GVHD Flares Requiring Increasing Immune Suppressive Therapy|Number of participants with GVHD flares requiring increasing immune suppressive therapy within 36 days of study initiation. Cumulative incidence of GVHD flares requiring increasing immune suppressive therapy will be analyzed using the competing risk method by Gray (1988). GVHD flares (progressive disease (PD)) may result in discontinuation from Panobinostat.|Up to 36 days per participant|All participants that received Oral Formulation LBH589 at MTD (5 mg) 3 times per week, for 4 weeks.|||participants|||Number
1418538|NCT01111526|Primary|Phase II: Overall Rate of Response (ORR)|Rate of Complete Response (CR), Partial Response (PR), Progressive Disease (PD) and Stable Disease (SD). Assessment of GVHD will include the skin, liver and gut. Other possible etiologies of organ disease such as C difficile enterocolitis, viral infection, drug reaction, veno-occlusive disease of the liver, etc., will be excluded by appropriate tests. CR is defined as resolution of GVHD in all evaluable organs with no subsequent additional treatment given for acute GVHD. PR is defined as improvement in ≥ one evaluable organ without deterioration in at least one other. PD is defined as deterioration in at least on evaluable organ. SD is defined as the absence of any difference sufficient to meet minimal criteria for improvement or deterioration in any evaluable organs.|1 year, 2 months|All participants treated at maximum tolerated dose (MTD) of Oral Formulation LBH589, and evaluable at planned time of analysis.|||participants|||Number
1418539|NCT01111526|Primary|Phase I: Maximum Tolerated Dose (MTD) in Milligrams|MTD of LBH589 in addition to glucocorticoids as treatment for Graft Versus Host Disease (GVHD) manifestations. MTD in Milligrams (mg), taken by mouth (PO), 3 times per week, for 4 weeks. The oral formulation replaced the IV formulation (which became unavailable) after the first 4 participants were treated. Dose limiting toxicity (DLT) is defined by the occurrence of Common Toxicity Criteria (CTC) grade 3 or greater toxicity that is unexpected with transplantation, except for hematological toxicity, where DLT is defined as absolute neutrophil count (ANC) <750, and for those participants who were platelet transfusion independent is defined as platelets <10 K.|2 years, 8 months|All participants treated with Oral Formulation LBH589, during Phase I Dose Escalation.|||MTD of oral LBH589 in milligrams|||Number
1418540|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Apparent Diffusion Coefficient (ADC) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in ADC for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 2 participants with evaluable data.|||Percentage change||Standard Deviation|Mean
1418541|NCT01111461|Other Pre-specified|Percentage Change From Baseline in the Contrast Volume Transfer Coefficient (Ktrans) Median|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of two DCE-MRI/DWI MRI scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included the percentage change in Ktrans for gadolinium chelate movement from the vasculature into the tissue extracellular space from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at a minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.|||Percentage change||Standard Deviation|Mean
1418542|NCT01111461|Other Pre-specified|Percentage Change From Baseline for the Imaging Biomarker Parameter of the Area Under the Plasma Concentration Curve Blood Normalized (90) (AUCBN (90)) Median for Total Volume|The antiangiogenic and direct antitumor effects of lenvatinib were assessed by analyses of 2 dynamic contrast-enhanced magnetic resonance imaging/diffusion-weighted magnetic resonance imaging (DCE-MRI/DWI MRI) scans obtained on evaluable participants at Baseline and Cycle 1 Day 5. The scans were obtained using standardized acquisition across sites. DWI sequences totaling approximately 30 seconds were acquired during the DCE-MRI scans. Centralized analysis metrics for DCE-MRI included percentage change in initial area under the gadolinium contrast agent time-concentration curve (first 90 seconds, blood normalized) from baseline.|Cycle 1 Day 5|Imaging biomarker analysis set included those participants who received at least 1 dose of lenvatinib and had, at minimum, a baseline and 1 postbaseline evaluable imaging assessment. n = 4 participants with evaluable data.|||Percentage change||Standard Deviation|Mean
1418543|NCT01111461|Other Pre-specified|Summary of Plasma Concentration of Lenvatinib|A total of 6 blood samples for pharmacokinetic (PK) analysis were collected from each participant who received lenvatinib once daily.|Predose and 2 hours postdose on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 2 Day 1|PK analysis set was used and included all participants with an evaluable plasma concentration.|||ng/mL||Standard Deviation|Mean
1418544|NCT01111461|Secondary|Number of Participants With Adverse Events (AEs) /Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib Tolerability of Lenvatinib|Safety was assessed by monitoring and recording all AEs and SAEs, regular monitoring of hematology, clinical chemistry, and urine values, regular measurement of vital signs, electrocardiograms (ECGs), and echocardiograms.|From the administration of first dose up to 30 days after the last dose, or up to data cut-off (21 May 2012), or up to approximately 26 months.|Safety Analysis Set included all participants who received at least 1 dose of lenvatinib and had at least 1 postbaseline safety evaluation. This was the analysis set for all safety evaluations.|||Participants|||Number
1418545|NCT01111461|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) [CR + PR + dSD] based on RECIST 1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 23 weeks), as determined by the IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Percentage of participants||95% Confidence Interval|Number
1418546|NCT01111461|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with BOR of CR or PR or stable disease (SD) based on RECIST 1.1 and SD lasting greater than or equal to 7 weeks, as determined by IRR and Investigator.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression, or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Percentage of participants||95% Confidence Interval|Number
1418547|NCT01111461|Secondary|Overall Survival (OS)|OS was the length time in months from the date of first treatment until the date of death from any cause. If death was not observed, OS was censored at the last known alive date or data cut-off. Additional survival follow-up data was collected for all participants who had not withdrawn consent and were alive at the time of the initial survival follow-up as of 26 Nov 2012 data cut-off. Participants who were lost to follow-up at the time of the initial assessment may have been contacted again at the investigator's discretion. Updated survival (based on 26 Nov 2012 cut-off) was derived for these participants if the contact was made successfully.|From date of first administration of study treatment until the date of death, or up to approximately 32 months (as of 26 Nov 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Months||95% Confidence Interval|Median
1418548|NCT01111461|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the date of first documentation of disease progression or date of death (whichever occurred first), as determined by independent radiologic review (IRR) and Investigator based on RECIST 1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions.|From date of first administration of study treatment until the date of first documentation of disease progression or date of death, if death occurred prior to disease progression or up to approximately 26 months (as of 21 May 2012 data cut-off)|Full Analysis Set (ITT Population) included all participants who received at least 1 dose of lenvatinib.|||Months||95% Confidence Interval|Median
1418549|NCT01111461|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was ≤10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR|From the date of first administration of study treatment until all participants completed a minimum of 6 cycles (28-day cycles) or discontinued treatment prior to the end of Cycle 6 (as of 21 May 2012 data cut-off)|Full Analysis Set (Intent-to-Treat [ITT] Analysis Set) was used and included all participants who received at least 1 dose lenvatinib.|||Percentage of participants||95% Confidence Interval|Number
1418550|NCT01111370|Primary|the Proportion of G4 CGM System in Agreement With the Reference Standard|The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels >80 mg/dL and (±) 20 mg/dL at YSI glucose levels <80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.|Assessment done on either Day 1, 4 or 7 of the sensor wear period|Randomly enrolled|||%20/20||95% Confidence Interval|Mean
1418551|NCT01111331|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry and assessment of tolerability by investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|Drug administration until beginning of next sequence/end of trial, 35 days|Treated set (TS) included all subjects who had taken at least one dose of trial medication.|||participants|||Number
1418552|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (PT AUEC0-tz,Base)|Area under the PT-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the PT-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s*hr||95% Confidence Interval|Geometric Mean
1418553|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time Adjusted to Baseline (PTmax,Base)|Peak prothrombin time adjusted for baseline value (before any trial drug administration) of peak prothrombin|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s||95% Confidence Interval|Geometric Mean
1418554|NCT01111331|Secondary|Warfarin: Area Under the PT-time Curve From 0 to Last Measurable Data Point (PT AUEC0-tz)|Area under the PT-time curve from time of dosing to time of last measurable data point|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s*hr||95% Confidence Interval|Geometric Mean
1418555|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point Adjusted to Baseline (INR AUEC0-tz,Base)|Area under the INR-time curve from time of dosing to time of last measurable data point adjusted for baseline value (before any trial drug administration) of area under the INR-time curve|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||ratio*h||95% Confidence Interval|Geometric Mean
1418556|NCT01111331|Secondary|Warfarin: Peak Prothrombin Time (PTmax)|Peak prothrombin time|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||s||95% Confidence Interval|Geometric Mean
1418557|NCT01111331|Secondary|Warfarin: Peak International Normalised Ratio Adjusted to Baseline (INRmax,Base)|Peak international normalised ratio for warfarin adjusted for baseline value (before any trial drug administration) of peak international normalised ratio|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||Ratio||95% Confidence Interval|Geometric Mean
1418558|NCT01111331|Secondary|Warfarin: Area Under the INR-time Curve From 0 to Last Measurable Data Point (INR AUEC0-tz)|Area under the concentration time curve of the INR measurements over the time interval from 0 to the time of the last quantifiable data point.|0 hours (h), 1h, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacodynamic (PD) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one PD endpoint without an important protocol violation with respect to the PD evaluation.|||ratio*h||95% Confidence Interval|Geometric Mean
1418649|NCT01111149|Primary|Smoking Abstinence - Serum/Urine Measurements|Measured by blood/urine tests for nicotine and its break-down product cotinine.|Week 12||||ng/mL||Standard Deviation|Mean
1418560|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
1418561|NCT01111331|Secondary|Warfarin S-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1418562|NCT01111331|Secondary|Warfarin S-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1418563|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1418564|NCT01111331|Secondary|Warfarin S-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1418565|NCT01111331|Secondary|Warfarin S-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
1418566|NCT01111331|Secondary|Warfarin S-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1418567|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Volume of Distribution Following Extravascular Administration (Vz/F)|Apparent volume of distribution during the terminal phase λz following extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
1418568|NCT01111331|Secondary|Warfarin R-enantiomers: Apparent Clearance After Extravascular Administration (CL/F)|Apparent clearance in plasma after extravascular administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1418569|NCT01111331|Secondary|Warfarin R-enantiomers: Mean Residence Time After Oral Administration (MRTpo)|Mean residence time of the analyte in the body after oral administration|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1418570|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Half-life (t1/2)|Terminal half-life of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1418571|NCT01111331|Secondary|Warfarin R-enantiomers: Terminal Rate Constant (λz)|Terminal rate constant in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1418572|NCT01111331|Secondary|Warfarin R-enantiomers: Time to Maximum Plasma Concentration (Tmax)|Time from dosing until maximum plasma concentration is reached|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
1418573|NCT01111331|Secondary|Warfarin R-enantiomers: Area Under the Curve 0 to Last Measurable Data Point (AUC0-tz)|Area under the plasma concentration-time curve from time of dosing to time of last measurable data point.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1418574|NCT01111331|Secondary|Empagliflozin: Apparent Volume of Distribution Following Extravascular Administration (Vz/F,ss)|"Apparent volume of distribution during the terminal phase at steady state following extravascular administration.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||L||Geometric Coefficient of Variation|Geometric Mean
1418575|NCT01111331|Secondary|Empagliflozin: Apparent Clearance at Steady State (CL/F,ss)|"Apparent clearance in plasma after extravascular administration at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1418576|NCT01111331|Secondary|Empagliflozin: Mean Residence Time at Steady State After Oral Administration (MRTpo,ss)|"Mean residence time of empagliflozin (empa) in the body at steady state after oral administration.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1418577|NCT01111331|Secondary|Empagliflozin: Time to Maximum Plasma Concentration at Steady State (Tmax,ss)|"Time from last dosing to maximum plasma concentration at steady state over a uniform dosing interval τ.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Full Range|Median
1418578|NCT01111331|Secondary|Empagliflozin: Terminal Half-life at Steady State (t1/2,ss)|"Terminal half-life of empagliflozin (empa) in plasma at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
1418579|NCT01111331|Secondary|Empagliflozin: Terminal Rate Constant at Steady State (λz,ss)|"Terminal rate constant of empagliflozin (empa) in plasma at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1419771|NCT01100437|Other Pre-specified|Naltrexone Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1418580|NCT01111331|Secondary|Empagliflozin: Plasma Concentration 24 Hours After Administration of Dose (C24,N)|Plasma concentration of empagliflozin (empa) measured 24 hours after administration of the fourth dose (Cpre,5) and after the sixth dose (Cpre,7).|24 hours after dose 4 or 6 respectively (day 5 and day 7)|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1418581|NCT01111331|Primary|Warfarin S-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1418582|NCT01111331|Primary|Warfarin S-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1418583|NCT01111331|Primary|Warfarin R-enantiomers: Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1418584|NCT01111331|Primary|Warfarin R-enantiomers: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the plasma concentration-time curve from time of dosing extrapolated to infinity.|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h after administration of warfarin for both warfarin alone and warfarin plus empagliflozin|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1418585|NCT01111331|Primary|Empagliflozin: Maximum Measured Concentration at Steady State(Cmax,ss)|"Maximum measured plasma concentration of empagliflozin (empa) for the dosing interval τ at steady state.~In addition to the below time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1418586|NCT01111331|Primary|Empagliflozin: Area Under the Curve for the Dosing Interval at Steady State (AUCτ,ss)|"Area under the plasma concentration-time curve for the dosing interval τ at steady state~In addition to the specified time frame, pre-dose samples were collected on Days 1, 3, and 4 for empa and a post-dose sample on day 1 for empa plus warfarin."|0 hours (h), 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h post-dose on Day 5 for for empa; 0h, 20min, 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 168h for empa plus warfarin.|Pharmacokinetic (PK) set included all subjects who had taken at least one dose of trial medication, provided at least one observation for at least one primary PK endpoint without an important protocol violation with respect to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1418587|NCT01111318|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator|Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).|Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days|Treated Set (TS) included all subjects who had been dispensed study medication and were documented to have taken the investigational treatment.|||participants|||Number
1418588|NCT01111318|Secondary|Urinary Glucose Excretion (UGE)|"Urinary glucose excretion, this endpoint was measured using Ae0-96.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||mg||Standard Deviation|Mean
1418589|NCT01111318|Secondary|Renal Clearance After Extravascular Administration (CL R)|"Renal clearance of empagliflozin (empa) in plasma after extravascular administration.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||mL/min||Standard Deviation|Mean
1418765|NCT01109316|Secondary|Mean Daily Insulin Dose (Total, Basal, and Bolus)||8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.|||Units (U) of insulin||Standard Deviation|Mean
1418590|NCT01111318|Secondary|Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))|"Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||percentage of empagliflozin||Standard Deviation|Mean
1418591|NCT01111318|Secondary|Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)|"Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.~The standard deviation is actually the coefficient of variation."|Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol||Standard Deviation|Mean
1418592|NCT01111318|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)|"Apparent volume of distribution during the terminal phase (λz).~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||L||Standard Deviation|Mean
1418593|NCT01111318|Secondary|Apparent Clearance After Extravascular Administration (CL/F)|"Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||mL/min||Standard Deviation|Mean
1418594|NCT01111318|Secondary|Mean Residence Time (MRTpo)|"Mean residence time of empagliflozin (empa) in the body.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||h||Standard Deviation|Mean
1418595|NCT01111318|Secondary|Terminal Half-Life (t1/2)|"Terminal half-life of empagliflozin (empa) in plasma.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||h||Standard Deviation|Mean
1418596|NCT01111318|Secondary|Terminal Rate Constant (λz)|"Terminal rate constant in plasma.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||1/h||Standard Deviation|Mean
1418597|NCT01111318|Secondary|Time From Dosing to Maximum Concentration (Tmax)|Time from dosing to maximum concentration of empagliflozin (empa) in plasma.|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||h||Full Range|Median
1418598|NCT01111318|Secondary|Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.~The standard deviation is actually the coefficient of variation."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol*h/L||Standard Deviation|Mean
1418599|NCT01111318|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagliflozin (empa) in plasma.~The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol/L||Standard Deviation|Mean
1418797|NCT01108809|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)||6 Months|Patients with data at 3rd visit|||Percentage of participants|||Number
1427916|NCT01027286|Secondary|Daily Narcotic Usage (Morphine-equivalent mg)||daily during hospital stay (an expected average of 4 days)||||morphine-equivalent mg||Standard Deviation|Mean
1418600|NCT01111318|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.~The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.|||nmol*h/L||Standard Deviation|Mean
1418601|NCT01111305|Secondary|Proportion of Subjects Who Clear Blood Microfilariae||3, 7, and 28 days after initiation of treatment with DEC||||Participants|||Count of Participants
1418602|NCT01111305|Secondary|Markers of Eosinophil Activation Including Levels of Eosinophil Surface Marker Expression and Serum Levels of Eosinophil Granule Proteins||two years||2017-12-31|12/2017||||
1418603|NCT01111305|Secondary|Frequency of AE's|Adverse events during the first week of DEC treatment|7 days following initiation of DEC treatment|Subjects who received DEC treatment|||adverse events|||Number
1418604|NCT01111305|Primary|Change in Peak Eosinophil Count Measure as a Percent of Baseline Count.|Peak eosinophil count during the first 7 days of treatment as a percent of the baseline count|during the first 7 days of DEC treatment|Subjects who received diethylcarbamazine treatment|||percent change||Full Range|Geometric Mean
1418605|NCT01111292|Primary|The Effect of Myo-inositol (Inositol) on P-β-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia.|The primary objective of this study will be to evaluate the effect of myo-inositol (inositol), administered for three months, on P-β-catenin staining in areas of low grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline.|Baseline to 90 days|pβ-cat-positive cell counts in pre- and post-study biopsies with dysplasia or adenoma. Counts are broken down as the number of crypts with 3, 4, or 5 pβ-cat positive cells. High frequency (HF) fields of view are those containing at least 2 crypts with three or more pβ-cat positive cells per crypt (at 20X). I|||Colonic Biopsies||Standard Deviation|Mean
1418606|NCT01111240|Secondary|Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication|Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs|Baseline, and Months 6 and 24|FAS|||percentage of participants|||Number
1418607|NCT01111240|Secondary|Percentage of Participants With In-Patient Hospitalization|Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||percentage of particpants|||Number
1418608|NCT01111240|Secondary|Mean Number of Days Missed From Work Due to Psoriatic Arthritis|Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||days||Standard Deviation|Mean
1418609|NCT01111240|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit||Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||percentage of participants|||Number
1418610|NCT01111240|Secondary|Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time|A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
1418611|NCT01111240|Secondary|Participants Assessment of Pain Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
1418612|NCT01111240|Secondary|Participants Assessment of Fatigue Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
1418613|NCT01111240|Secondary|Patients Global Assessment of Disease Activity Over Time|Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant’s status.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||scores on a scale||Standard Deviation|Mean
1418614|NCT01111240|Secondary|Mean C-Reactive Protein (CRP) Levels Over Time|The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||mg/L||Standard Deviation|Mean
1418651|NCT01111123|Primary|Physical Global Assessment|Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the intention-to-treat population (ITT).|||participants|||Number
1418615|NCT01111240|Secondary|Mean Erythrocyte Sedimentation Rate (ESR) Over Time|The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||mm/hour||Standard Deviation|Mean
1418616|NCT01111240|Secondary|Number of Participants by Severity of Nail Psoriasis Levels Over Time|Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||participants|||Number
1418617|NCT01111240|Secondary|Number of Participants by Severity of Dactylitis Over Time|Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to “sausage digit,” involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||participants|||Number
1418618|NCT01111240|Secondary|Number of Participants by Severity of Enthesitis Over Time|Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||participants|||Number
1418619|NCT01111240|Primary|Number of Participants With Adverse Events (AEs)|Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.|Baseline up to 24 months|Safety Set - All enrolled participants|||participants|||Number
1418620|NCT01111240|Primary|Mean Target Lesion Score (TLS) Over Time|The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||score on a scale||Standard Deviation|Mean
1418621|NCT01111240|Primary|Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time|Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient’s hand was equal to 1% BSA.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||percentage of body surface area||Standard Deviation|Mean
1418622|NCT01111240|Primary|Mean Swollen Joint Count (SJC) Over Time|Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||Swollen Joints||Standard Deviation|Mean
1418623|NCT01111240|Primary|Mean Tender Joint Count (TJC) Over Time|Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.|Baseline, and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||Tender joints||Standard Deviation|Mean
1418650|NCT01111123|Secondary|Signs of Psoriasis, Atrophy or Telangiectasis|Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score.|During the maintenance phase, from 2 weeks up to 26 weeks|The primary endpoint was a change in PGA during the 24 weeks of the study in the ITT.|||participants|||Number
1429627|NCT01012414|Secondary|Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.||1 year|Data were not collected when study was stopped prematurely.||||||
1418624|NCT01111240|Primary|Mean Change From Baseline in Disease Activity Score (DAS)28|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.|||score on a scale||Standard Deviation|Mean
1418625|NCT01111162|Primary|Immunogenicity|Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose.|21-28 days|Among the 90 participants without evidence of previous exposure to H1N1, only 61% [95% confidence interval (CI) 51–71] developed protective titers by week 3 of the study (seroconversion rate).|||percentage of seroconversion||95% Confidence Interval|Number
1418626|NCT01111162|Primary|Safety|"To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care).~Safety was assessed via~Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses.~Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination."|21-28 days||||percentage of participants|||Number
1418627|NCT01111149|Secondary|Abnormal Movements - AIMS|Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167.|Week 12||||units on a scale||Standard Deviation|Mean
1418628|NCT01111149|Secondary|Urge to Smoke - MNWS|The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke.|Week 12||||percentage of time||Standard Deviation|Mean
1418629|NCT01111149|Secondary|Abstinence Related Symptoms - WISDM|The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154.|Week 12||||units on a scale||Standard Deviation|Mean
1418630|NCT01111149|Secondary|Response Style Indicator (Beta) for CPT|Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12.|Week 12||||Beta||Standard Deviation|Mean
1418631|NCT01111149|Secondary|Detectibility (d') of Continuous Performance Test|The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12.|Week 12||||unitless||Standard Deviation|Mean
1418632|NCT01111149|Secondary|Variability of Standard Error - CPT|"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures within respondent variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12."|Week 12||||milliseconds||Standard Deviation|Mean
1418633|NCT01111149|Secondary|Hit Reaction Time - CPT|The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12.|Week 12||||milliseconds||Standard Deviation|Mean
1418634|NCT01111149|Secondary|General Psychopathology|Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267.|Week 12||||units on a scale||Standard Deviation|Mean
1418635|NCT01111149|Secondary|Positive Symptoms of Schizophrenia (SAPS)|Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
1418636|NCT01111149|Secondary|Suicidality|The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity.|Week 12||||units on a scale||Standard Deviation|Mean
1418637|NCT01111149|Secondary|Vital Signs - Pulse|Pulse will be measured. The values below were measured at week 12 of the study.|Week 12||||heart beats per minute||Standard Deviation|Mean
1418638|NCT01111149|Primary|Smoking Abstinence - Exhaled Carbon Monoxide|Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.|Week 12||||parts per million||Standard Deviation|Mean
1418639|NCT01111149|Primary|Smoking Abstinence - Number of Cigarettes Smoked|Number of cigarettes smoked at week 12 of the study by self-report.|Week 12||||number of cigarettes smoked||Standard Deviation|Mean
1418640|NCT01111149|Secondary|Vital Signs - Weight|Weight will be measured for each participant. Values listed below are for week 12.|Week 12||||lbs||Standard Deviation|Mean
1418641|NCT01111149|Secondary|Vital Signs|blood pressure will be measured.|Week 12||||mm Hg||Standard Deviation|Mean
1418642|NCT01111149|Secondary|Abnormal Movements - BAS and SAS|"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.~Simpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity."|Week 12||||units on a scale||Standard Deviation|Mean
1418643|NCT01111149|Secondary|Depression|Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression.|Week 12||||units on a scale||Standard Deviation|Mean
1418644|NCT01111149|Secondary|Abstinence-related Symptoms - MNWS and FTND|"Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges.~The Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine."|Week 12||||units on a scale||Standard Deviation|Mean
1418645|NCT01111149|Secondary|Side Effects|Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study.|Week 12||||participants|||Number
1418646|NCT01111149|Secondary|Impulsivity and Inattention|Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity.|Week 12||||Percentage of responses||Standard Deviation|Mean
1418647|NCT01111149|Secondary|Negative Symptoms of Schizophrenia - SANS|Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
1418648|NCT01111149|Secondary|Reduction in Smoking|Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12|Week 12||||participants|||Number
1418652|NCT01111110|Primary|Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber|fifteen minutes after 4 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.|||Diff in % change from 4AM||Standard Deviation|Mean
1418653|NCT01111110|Primary|Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber|15 minutes after 2 puffs of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.|||Diff in % change from 4AM||Standard Deviation|Mean
1418654|NCT01111110|Primary|Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.|(Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber|fifteen minutes after 1 puff of albuterol|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.|||Diff in % change from 4AM||Standard Error|Mean
1418655|NCT01110967|Primary|Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)||Patients were followed up according to the local practice, up to 1 year||||events|||Number
1418656|NCT01110967|Secondary|Changes in Device Placement||Up to 12 months follow up visit||||participant|||Number
1418657|NCT01110967|Secondary|Device Subsidence Measured as Interbody Height Ratio (IBHR)|Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.|Up to 12 months follow up visit||||ratio||Standard Deviation|Mean
1418658|NCT01110967|Secondary|Intervertebral Disc Space (IVD) at Implanted Level|The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as [(A+B)/2]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.|Up to 12 months follow up visit||||mm||Standard Deviation|Mean
1418659|NCT01110967|Secondary|Range of Motion (ROM) at Implanted Level|The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).|Up to 12 months follow up visit||||degrees||Standard Deviation|Mean
1418660|NCT01110967|Primary|Physical Functioning Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.|Up to 12 months follow up visit||||units on a scale||Standard Deviation|Mean
1418661|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit||||units on a scale||Standard Deviation|Mean
1418662|NCT01110967|Primary|Health-related Quality of Life Using the Visual Analogue Scale for Back Pain|The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.|Up to 12 months follow up visit||||units on a scale||Standard Deviation|Mean
1418663|NCT01110915|Secondary|System-related Complications|Subjects with a complication related to the implanted system, which consisted of the pacemaker, leads to the right chambers of the heart (atrium and ventricle), pacemaker software, and programmer. All adverse events in the time frame were recorded at the subject's center and assessed the AEAC. The AEAC determined whether each adverse event was a complication (requiring invasive intervention), and whether the event was related to the system.|Implant to four months post implant||||participants|||Number
1418664|NCT01110915|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the AEAC.|During MRI scans|All subjects successfully implanted with the Advisa MRI system who underwent MRI scans were included in the analysis. All MRI scans, whether done at the 9-12 week visit in the MRI group, or done at other times in either group were included in this analysis.|||participants|||Number
1418665|NCT01110915|Secondary|Ventricular Sensed Amplitude Success|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.|||participants|||Number
1418666|NCT01110915|Secondary|Atrial Sensed Amplitude Success|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.|||participants|||Number
1426114|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 28||||percentage of donor cells||Standard Deviation|Mean
1418667|NCT01110915|Primary|Ventricular Pacing Capture Threshold Success|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI /waiting period to 1-month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.|||participants|||Number
1418668|NCT01110915|Primary|Atrial Pacing Capture Threshold Success|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.|||participants|||Number
1418669|NCT01110915|Primary|Magnetic Resonance Imaging (MRI)-Related Complications|For each subject in this objective, the endpoint was the occurrence of an MRI-related complication within 30 days post-MRI. An independent Adverse Event Advisory Committee (AEAC) determined whether each adverse event was a complication and whether it was MRI-related.|MRI scan to one-month post-MRI scan|Subjects who had an MRI scan and completed their 4-month visit (or a later follow-up), or had an MRI-related complication within one month post-MRI were included in the analysis.|||participants|||Number
1418670|NCT01110707|Secondary|Mean Number of Oocytes Retrieved|Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocyte from the ovary of the female subject, enabling fertilization outside the body.|36 hours post r-hCG administration|The ITT analysis included all the randomized subjects who received at least 1 dose of study medication.|||Oocytes||Standard Deviation|Mean
1418671|NCT01110707|Secondary|Number of Cycles Cancelled Due to Unsatisfactory Response|If the subject was not administered with r-hCG and withdrew prematurely from the trail, it is considered as cycle cancellation|r-hCG day (end of stimulation cycle [approximately 28 days])|The ITT analysis included all the randomized subjects who received at least one dose of study medication.|||cycles|||Number
1418672|NCT01110707|Secondary|Endometrial Thickness||r-hCG day (end of stimulation cycle [approximately 28 days])|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||mm||Standard Deviation|Mean
1418673|NCT01110707|Secondary|Mean Number of Follicles Greater Than or Equal to (>=) 14 Millimeter (mm)|Mean number of follicles as per the following categories were presented: >=14 mm and less than (<) 16 mm; >=16 mm and <18 mm and >=18 mm.|r-hCG day (end of stimulation cycle [approximately 28 days])|The ITT analysis included all the randomized subjects who received at least 1 dose of study medication.|||Follicles||Standard Deviation|Mean
1418674|NCT01110707|Secondary|Clinical Pregnancy Rate|Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.|35-42 days post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||Percentage of subjects|||Number
1418675|NCT01110707|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|35-42 days post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||Percent sacs per embryo|||Number
1418676|NCT01110707|Secondary|Quality of Embryos|Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation. Mean number of embryos for each of the 5 grades were reported.|Day 2-3 post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||embryos||Standard Deviation|Mean
1418677|NCT01110707|Secondary|Number of Fertilized Oocytes (2 Pronuclei [2PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|36 hours post r-hCG administration|The ITT analysis set included all the randomized subjects who received at least 1 dose of study medication.|||2PN oocytes||Standard Deviation|Mean
1418678|NCT01110707|Primary|Mean Number of Metaphase II (M-II) Oocytes Retrieved|Mean number of M-II oocytes were calculated for subjects undergoing ovum pick up for Intra-cytoplasmic Sperm Injection (ICSI). ICSI is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|36 hours post r-hCG administration|The Intention-To-Treat (ITT) analysis set included all the randomized subjects who received at least 1 dose of study medication.|||M-II oocytes||Standard Deviation|Mean
1418679|NCT01110499|Primary|Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.|Baseline, Day 29|Modified Intent to Treat: all randomized and treated patients who provided IOP data for baseline and at least one postbaseline hour 0 assessment|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1418680|NCT01110499|Primary|Part 1: Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.|Baseline, Day 7|Safety Population: all treated patients|||Millimeters of Mercury (mmHg)|Participants|Standard Deviation|Mean
1419772|NCT01100437|Other Pre-specified|Morphine Plasma Concentration at First COWS ≥ 13 in the Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of participants with COWS ≥ 13|||ng/mL||Standard Deviation|Mean
1418681|NCT01110421|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
1418682|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
1418683|NCT01110421|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
1418684|NCT01110421|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response Rate|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens at baseline and were excluded from this set.|||Participants|||Number
1418685|NCT01110421|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms showed no evidence of resurgence after administration of the last dose of study medication and no nonstudy systemic antibacterial therapy was given for the treatment of pneumonia.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract (LRT) culture, pleural fluid or blood culture.|||Participants|||Number
1418686|NCT01110421|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|Participants were considered as clinical improved if they had no fever, clinical improvement in signs and symptoms of pneumonia from baseline, decrease in WBC, improvement or lack of progression of radiographic findings in comparison with the screening chest X-ray, and not received any nonstudy systemic antibacterial therapy for the treatment of pneumonia after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical intent-to-treat: All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.|||Participants|||Number
1418741|NCT01109602|Secondary|Quality of Life - Measured With the Stroke Specific Quality of Life|Quality of Life was measured using the validated 49 items of the Stroke Specific QoL scale (SSQoL). The SSQoL includes assessment of 12 domains: self-care; vision; language; mobility; work; upper extremity; thinking; personality; mood; family; social; and energy. Prior work indicates good psychometric properties. Higher scores indicate increased QoL. Range of scores is 13 to 65 for the total score.|2 months||||units on a scale||Standard Deviation|Mean
1418687|NCT01110421|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-To-Treat (CITT): All randomized participants who met the minimal disease definition of pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.|||Participants|||Number
1418688|NCT01110408|Secondary|Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
1418689|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
1418690|NCT01110408|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
1418691|NCT01110408|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.|||Participants|||Number
1418692|NCT01110408|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.|||Participants|||Number
1418693|NCT01110408|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.|||Participants|||Number
1418694|NCT01110408|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.|||Participants|||Number
1418695|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated at baseline from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
1418696|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|TOC (7 to 14 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
1418697|NCT01110382|Secondary|Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit|A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
1418698|NCT01110382|Secondary|The Number of Participants With Favorable Per-participant Microbiological Response|Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).|EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)|Microbiological intent-to-treat - Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.|||participants|||Number
1418699|NCT01110382|Secondary|The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|LFU (28 to 42 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.|||participants|||Number
1418700|NCT01110382|Secondary|The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit|The participants were considered as clinical improved if they had clinical improvement in signs and symptoms of the intra-abdominal infection, no fever, decrease in WBC, and not received any nonstudy antibiotics for the treatment of intra-abdominal infection after IV study drug therapy had begun.|EIV (within 24 hours after completion of the last dose of IV study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.|||participants|||Number
1418701|NCT01110382|Primary|The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit|The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit.|TOC (7 to 14 days after the last dose of study medication therapy)|Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.|||participants|||Number
1418742|NCT01109602|Primary|Balance - Measured With the Berg Balance Scale|Balance was assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable and valid after stroke. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.|2 months||||units on a scale||Standard Deviation|Mean
1418702|NCT01110330|Secondary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6|Overall Cure (OC) was defined as Mycological Cure (MC) in addition to a global clinical evaluation of either ‘Completely Cleared’ (clearance of all signs and symptoms of Tinea pedis) or ‘Marked Improvement’ (significant improvement of signs and symptoms of Tinea pedis; residual signs and symptoms only), assessed at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Secondary Outcome Measure.|||participants|||Number
1418703|NCT01110330|Primary|The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6|Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.|Week 6|Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary Outcome Measure.|||participants|||Number
1418704|NCT01110252|Primary|Vital Capacity - VC|A pulmonary function test that measures the volume and speed of the inhalated and exhaled air.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure.|||liters||Standard Deviation|Mean
1418705|NCT01110252|Secondary|Arterial Blood Gases Test - Pa CO2|presence of CO2 in the arterial blood.|baseline and 30 days after the procedure|all patients were evaluated prior and after the procedure|||mm Hg||Standard Deviation|Mean
1418706|NCT01110252|Secondary|Arterial Blood Gases Test - Pa O2|presence of oxygen in the blood gases.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure.|||mmHg||Standard Deviation|Mean
1418707|NCT01110252|Primary|Forced Expiratory Volume (FEV1)|A pulmonary function test that measures the volume and speed of the exhaled air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure|||liters||Standard Deviation|Mean
1418708|NCT01110252|Primary|Forced Vital Capacity (FVC)|A pulmonary function test that measures the volume and speed of the inhalated air.|baseline and 30 days after procedure|all patients were evaluated prior and after the procedure|||liters||Standard Deviation|Mean
1418709|NCT01110239|Primary|Visual Analog Scale Score as a Measure of Tolerability|The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.|90 days|We escalated the ischemia times in cohorts of 6. Cohorts of 6 were prespecified at the beginning to the study. All analysis was intention to treat|||units on a scale||Standard Deviation|Mean
1418710|NCT01110239|Primary|Number of Patients With Deep Vein Thrombosis for Safety Assessment.||90 days||||participants|||Number
1418711|NCT01110200|Secondary|Number of EXs of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization (Alone and in Combination)|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population. Only those participants with an EX were assessed for hospitalization, treatment with OCSs, and treatment with ABs.|||exacerbations|||Number
1418712|NCT01110200|Secondary|Number of Participants With an EX of COPD Requiring Treatment With OCSs, Treatment With ABs, and/or Hospitalization|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit).|From Baseline up to Week 29, approximately|ITT Population|||participants|||Number
1418713|NCT01110200|Primary|Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population. Only those participants with an EX requiring hospitalization were assessed.|||Exacerbations|||Number
1418714|NCT01110200|Primary|Number of Participants With the Indicated Number of EXs of COPD Requiring Hospitalization That Occurred More Than 21 Days Post-discharge or Physician's Office Visit for an EX of COPD Requiring Treatment With OCSs or OCSs and ABs|A COPD EX was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur more than 21 days post-discharge or physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|ITT Population|||participants|||Number
1418743|NCT01109602|Secondary|Balance Self-efficacy - Measured With the Activities Balance Confidence Scale|The 16 item Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. The ABC is a self-report of a participant's self-efficacy in maintaining static and dynamic balance control during functional tasks. The validity and reliability of the ABC have been previously demonstrated in individuals with stroke. Scoring is 'no confidence' (0%) to 'completely confident' (100%).|2 months||||units on a scale||Standard Deviation|Mean
1419065|NCT01106833|Secondary|Percentage of Participants With Secondary Immunosuppressive Therapy Initiated|The percentage of participants initiating secondary immunosuppressive therapy for chronic GVHD is described. Death is considered a competing risk for this endpoint.|Up to 2 years post-randomization||||percentage of participants||95% Confidence Interval|Number
1418715|NCT01110200|Primary|Number of Par. With Chronic Obstructive Pulmonary Disease (COPD) EXs Requiring Hospitalization That Occurred >21 Days Post-discharge/Physician's Office Visit for a COPD EX Requiring Treatment With Oral Corticosteroids (OCSs) or OCSs and Antibiotics (ABs)|A COPD exacerbation (EX) was defined as the worsening of >=2 major symptoms (dyspnoea, sputum volume, sputum purulence [containing/discharging pus]) or the worsening of any 1 major symptom together with any 1 minor symptom (sore throat, cold [nasal discharge and/or nasal conjestion], fever without other cause, increased cough or wheeze) for at least 2 consecutive days. COPD EXs were identified by symptom review, and/or were based on investigator judgment (via phone contact or at a clinic visit). Hospitalization had to occur >21 days post-discharge/physician’s office visit for a prior COPD EX.|From 21 days post-discharge (hospital or emergency room) or physician's office visit, up to 29 weeks|Intent-to-Treat (ITT) Population: all participants randomized to study drug|||participants|||Number
1418716|NCT01110187|Secondary|Number of Participants With Seizures|Number of seizures in the first 72 hours based on EEG recording|baseline to 72 hours||||number of participants with seizures|||Number
1418717|NCT01110187|Primary|Number of Adverse Events|The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.|baseline to 7 days|all participants in each arm were available for analyses|||number of events experienced|||Number
1418718|NCT01110135|Primary|Successful Mobilization and Collection of PBSCs|Count of participants with successful mobilization and collection of PBSCs. Defined as collection of > 2 x 10^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%.|Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride||||Participants|||Count of Participants
1418719|NCT01110005|Secondary|Time to Delivery|Compare time to delivery between the D5LR and LR treatment groups|From onset of labor to delivery||||hours||Inter-Quartile Range|Median
1418720|NCT01110005|Secondary|Oxytocin Augmentation|Compare augmentation rates between the D5LR and LR treatment groups|From onset of labor to delivery||||Participants|||Count of Participants
1418721|NCT01110005|Primary|C-Section|Compare c-section rates between the D5LR and LR treatment groups|From onset of labor to delivery||||Participants|||Count of Participants
1418722|NCT01109979|Primary|Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)|This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increase in shear stress causes nitric oxide release and resulting vasodilation of the brachial artery (flow-mediated vasodilation). The flow-mediated changes in brachial artery diameter can be imaged by ultrasound and measured as an index of peripheral vasomotor function. BAR correlates with invasive assessments of coronary endothelial function as well as multiple cardiovascular risk factors.|%FMD after 6 weeks of treatment|The number of participants for analysis includes only the participants that completed a baseline assessment and at least one of the treatment arms.|||% FMD after 6 weeks of treatment||Standard Deviation|Mean
1418723|NCT01109849|Post-Hoc|Change in BMI z Score During Weight Recovery Period (Second Randomization) Based on Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental BMI increase."|between 1 month and 24 months|all participants prescribed an ER stimulant and also assigned to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 15.|||Z score||Standard Deviation|Mean
1418724|NCT01109849|Post-Hoc|Change in Weight z Score During Weight Recovery Phase (Second Randomization) Based on Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Higher values reflect greater incremental weight gain."|between 1 month and 24 months|participants using an ER stimualnt and also randomized to one of the weight recovery treatments. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 14.|||zscore||Standard Deviation|Mean
1418744|NCT01109576|Primary|Change in Profile of Mood States Total Score.|The change in Profile of Mood States total score is defined as the 8 week follow-up total score minus the baseline POMS total score. The scale measures change in mood states before and after treatment. The change score can range from -232 to 232, with negative values indicating greater reduction in emotional distress.|Change in Profile of Mood States Score from Baseline to 8 Weeks||||units on a scale||Standard Deviation|Mean
1418725|NCT01109849|Post-Hoc|Difference in Height z Score During Weight Recovery Phase (Second Randomization) by Actual Usage|"difference in height z score from entry into weight recovery phase to exit from that phase (exact duration varied by participant). Randomization could not occur before month 6 (so max of 24 month duration) but could start as late as month 29 (equaling a 1 month duration) based on the pattern of zBMI change. In this post hoc analysis we grouped participants by what they did (caloric supplementation, drug holiday or monitoring) not what they were randomly assigned to. The most common change was from drug holiday to monitoring for participants who were not using medication on weekends before assignment to drug holiday (family stopped weekend med by own accord prior to 2nd randomization) so assignment to drug holiday did not alter actual frequency of use as was designed to.Therefore they were reclassified as monitoring as frequency of med use did not change.~Z score used to account for differences in age and gender between groups. Larger values reflect greater height change."|between 1 month and 24 months|all participants using an ER stimulant and were also assigned to a weight recovery arm. Arms from first randomization are not included as not all of those participants progressed to the second randomization which was done adaptively based on change in zBMI. Those arms are reported on for outcome 13.|||Z score||Standard Deviation|Mean
1418726|NCT01109849|Post-Hoc|Change in BMI z Score by Actual Medication Usage|measures change in BMI z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a larger BMI|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 3 and 12).|||Z score||Standard Deviation|Mean
1418727|NCT01109849|Post-Hoc|Change in Weight z Score by Actual Medication Usage|measures change in weight z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used med for at least 87.5% of their time in the study with most using the entire time). The inconsistent med group (N=111, 27.5% used medication 45% of the time in the study. The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. Higher values represent a greater incremental weight gain.|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 2 and 11).|||Z score||Standard Deviation|Mean
1418728|NCT01109849|Post-Hoc|Change in Height z Score by Actual Medication Usage|measures change in height z score from baseline to last assessment with participants grouped based on actual medication usage versus randomly assigned group since participants were allowed to cross treatment arms after 6 months and not all participants assigned to medication used it consistently. The rarely med group (n=44) used med <12.5% of the study duration (with most using not at all). The consistent med group (N=38 used) med for at least 87.5% of their time in the study with most using the entire time. The inconsistent med group (N=111), used medication between 12.5 to 87.5 of the time (mean time on med was 45% of the time in the study) The other 37 participants did not have one year of growth data so were excluded from this analysis. Z scores used to account for differences in age and gender between groups. More negative values reflecting a smaller incremental height gain.|baseline to month 30 or last assessment point|Includes all participants with at least one year of growth data as goal was to assess impact of extended treatment on growth. These same outcomes are reported elsewhere for the first randomization arms of Behavior Therapy and Med as well as the second randomization arms of cal supplement, drug holiday and monitoring (see outcomes 1 and 10).|||Z score||Standard Deviation|Mean
1418729|NCT01109849|Secondary|Change in Zscore for BMI During Weight Recovery Phase (Second Randomization)|"difference in BMI z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. Larger values reflecting a greater incremental BMI gain."|between 1 month and 24 months|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.|||Z score||Standard Deviation|Mean
1418730|NCT01109849|Secondary|Change in Weight z Score During Weight Recovery Phase (Second Randomization)|"difference in weight z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. Larger values reflect a greater incremental weight gain."|1 to 24 months duration|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.|||Z score||Standard Deviation|Mean
1418763|NCT01109316|Secondary|Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%||8 weeks for each treatment|All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.|||participants|||Number
1418731|NCT01109849|Secondary|Change in Height z Score During Weight Recovery Phase (Second Randomization)|"difference in height z score from entry into weight recovery phase to exit from weight recovery phase (exact duration varied by participant). Randomization could not occur before month 6 (equaling a 24 month duration) but could start as late as month 29 (equaling a 1 month duration) of treatment based on the pattern of zBMI change by the individual participant.~Z scores used to account for differences in age and gender. More negative values reflecting less incremental height gain."|between 1 month and 24 months|all participants prescribed an ER stimulant who were also went through the second randomization to one of three weight recovery interventions. One monitoring participant never prescribed med was excluded.First randomization arms not included as not all of those participants had a second randomization as it was adaptively based on change in zBMI.|||Z score||Standard Deviation|Mean
1418732|NCT01109849|Secondary|Number of Behavior Therapy Sessions|Raw number of behavior therapy sessions attended; participants could cross over to other treatment arm if moderately impaired after 6 months in initial randomly assigned arm|months 0 through 30|those with at least one follow up assessment. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment.|||sessions attended||Standard Deviation|Mean
1418733|NCT01109849|Secondary|Medication Adherence|% of study days that study ADHD medication was taken when prescribed to be taken; behavior group could be prescribed medication if moderately impaired still after month 6. Once prescribed, all medication was prescribed to be taken 7 days a week except for in the drug holiday weight recovery arm.|denominator is number of days in study for which study med was prescribed|any participants with at least one dose of med prescribed. The second randomization arms are not included as all participants in those arms are derived from these two groups and this assessment period includes the entire duration of the second randomization. Also, the second randomization addressees weight gain, not ADHD treatment.|||% of days dose taken as prescribed|||Number
1418734|NCT01109849|Secondary|ADHD Symptoms- Teacher Rated|sum of items on 10 item IOWA Conners with range from 0-30 and larger values indicating greater symptoms. Collected at endpoint or last assessment point.|month 30 or last assessment point|those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization.|||units on a scale||Standard Deviation|Mean
1418735|NCT01109849|Secondary|Change Score for Zheight Months 0 to 6|"in addition to the primary outcome of height at month 30, change in z-height from baseline to study month 6 post is also reported. Subjects who were still moderately impaired after 6 months in their initial treatment arm were allowed to cross over and receive the treatments in the other arm so prior to month 6 no participants randomized to behavior arm were prescribed study medication.~This outcome includes all participants with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization which did not occur until after this assessment period was over.~Height converted to z score to account for differences in age and gender. More negative values reflecting smaller incremental height gain.~If participant dropped out prior to month 6, then the last assessment point was used."|baseline to month 6|participants with at height measurement at month 6|||Z score||Standard Deviation|Mean
1418736|NCT01109849|Secondary|ADHD Symptoms- Parent Rated|sum of score on 10 item IOWA Conners with range from 0 to 30 and higher values indicating more symptoms. Collected at end point or last assessment point.|at month 30 or last collected assessment point|those assigned to either Behavior therapy or ER stimulant with at least one post baseline assessment of ADHD symptoms. Second randomization arms (drug holiday, cal supplement, monitoring) not included as only relevant outcomes are ht, wt and BMI. All subjects in these arms are either in behavior therapy or er stimulant arm from 1st randomization.|||units on a scale||Standard Deviation|Mean
1418737|NCT01109849|Secondary|Treatment Adherence for Caloric Supplement|percent of days caloric supplement were taken versus prescribed in caloric supplement arm|from entry to exit of caloric supplement arm|those assigned to caloric supplement group|||percentage of days||Standard Deviation|Mean
1418738|NCT01109849|Secondary|Change in zBody Mass Index (BMI)|BMI will be calculated at endpoint (month 30). Difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting less BMI gain. Z units used to account for differences between groups in gender and age with both impact BMI at a fixed time.|baseline to month 30 or last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #12 for change in zBMI from beginning to end of second randomization.|||Z score||Standard Deviation|Mean
1418739|NCT01109849|Secondary|Change Score for z Weight|difference between baseline and endpoint (month 30 or last assessment point if did not finish study). Measured as a zscore with more negative units reflecting lesser weight gain. Z units used to account for differences between groups in gender and age with both impact weight at a fixed time.|baseline to month 30 or to last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, caloric supplement, monitoring) as they did not exist until 2nd randomization. See outcome #11 for change in zwt from beginning to end of second randomization.|||Z score||Standard Deviation|Mean
1418740|NCT01109849|Primary|Change Score for Z-height Baseline to Endpoint|"The primary endpoint will be change in z-height at month 30 which is study endpoint.~Measured as a zscore with more negative units reflecting smaller incremental height gain. Z units used to account for differences between groups in gender and age with both impact height at a fixed time."|month 30 or last assessment point|includes all with 2+ growth assessments from the behavior therapy and ER stimulant arms. Doesn't include adaptive randomization arms (drug holiday, cal supplement, monitoring) as they didn't exist until 2nd randomization. See outcome #10 for change in zht from beginning to end of second randomization.|||Z score||Standard Deviation|Mean
1419066|NCT01106833|Secondary|Percentage of Participants With Relapse|Relapse is defined as recurrence of the primary malignancy. Death is considered a competing risk for this endpoint.|Up to 2 years post-randomization||||percentage of participants||95% Confidence Interval|Number
1418745|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population|Drug-related AEs (investigator assessment): those with relationship to study drug(s)reported as related and those of unknown relationship. Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several MedDRA terms (MedDRA version 14.0). Except for Gr 3 and 4 infusion reactions, AE severity per NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Gr 3 - 4 infusion reactions: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=life-threatening event with same Gr 3 symptomatology, complicated by symptomatic hypotension/oxygen saturation 70% or less. Day 1=start of study drug; to 30 days after last dose of any treatment.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.|||participants|||Number
1418746|NCT01109524|Primary|Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|Drug-related AEs and drug-related SAEs (by investigator assessment) were those with a relationship to study drug(s) reported to Sponsor as related and those of unknown relationship. AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE was defined as a medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.|||participants|||Number
1418747|NCT01109524|Primary|Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 – 155 mmol/L; Gr 3: >155 – 160mmol/L; Gr 4: >160 mmol/L. Sodium low(L) Gr 1:<LLN – 130mmol/L; Gr 3: <130 – 120 mmol/L; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5 mmol/L; Gr 2: >5.5 – 6.0 mmol/L; Gr 3: > 6.0 – 7.0 mmol/L; Gr 4: >7.0 mmol/L. Potassium (L) Gr 1: <LLN – 3.0 mmol/L; Gr 2: <LLN – 3.0 mmol/L; Gr 3: < 3.0 – 2.5 mmol/L; Gr 4: <2.5 mmol/L. Serum creatinine (H) Gr 1: >1 – 1.5*baseline (BL)to >ULN – 1.5*ULN; Gr 2: >1.5 – 3.0*BL to > 1.5 – 3.0*ULN; Gr 3: >3.0*BL to > 3.0 – 6.0*ULN; Gr 4: >6.0*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy.|Day 1 up to 30 days after last dose|Treated population: All participants who received at least one dose of any study drug.|||participants|||Number
1418748|NCT01109524|Primary|Number of Participants With Hematology Laboratory Abnormalities - Treated Population|Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10^9/μL.|Day 2 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug. Participants with at least one on-study laboratory measurement available were analyzed.|||participants|||Number
1418749|NCT01109524|Primary|Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population|ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN. Albumin (low) Grade 1:<LLN - 3 grams per deciliter (g/dL)to <LLN - 3 g/dL; Grade 2: <3 - 2 g/dL to < 3.0 - 2.0 g/dL; Grade 3: < 2 g/dL to <2 g/L. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Number (N) of participants with laboratory data available and who could be analyzed for total bilirubin was 49. All other liver function laboratories N=57. Treated population: all participants who received at least one dose of any study drug.|||participants|||Number
1418750|NCT01109524|Primary|Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population|Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.|||participants|||Number
1418764|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values||Baseline, 8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1419114|NCT01106586|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT analysis set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).|||percentage of participants|||Number
1418751|NCT01109524|Primary|Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy.|Day 1 up to 30 days after last dose|Treated population: all participants who received at least one dose of any study drug.|||participants|||Number
1418752|NCT01109381|Secondary|Assessment of Adverse Events (AE)|Adverse event data will be collected in response to neutral questioning.|AE commencing within 30 days of initiation of treatment, followed until resolution|All participants entering the study are included in the safety analysis|||participants|||Number
1418753|NCT01109381|Primary|Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)|Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).|up to 14 days of treatment|All 21 Initial Phase participants had a pretreatment gastroscopy, and 20 had post-treatment gastroscopy (one participant prematurely discontinued the study prior to receiving GT08, and the participant later lost to follow up had a post-treatment gastroscopy before being lost to follow up)|||participants|||Number
1418754|NCT01109381|Primary|Number of Participants With Eradication of H.Pylori Infection|Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment|4-6 weeks following treatment|Two participants did not complete the study, one discontinuing after experiencing adverse events while receiving only the initial study omeprazole, and the other participant left Singapore before they had their final urea breath test. All other study participants were analysed for efficacy.|||participants|||Number
1418755|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.|||mmHg||Standard Deviation|Mean
1418756|NCT01109316|Secondary|Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight||Baseline, 8 weeks for each treatment|All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.|||kilograms (kg)||Standard Deviation|Mean
1418757|NCT01109316|Secondary|Hypoglycemia Episode Rate Per 30 Days|"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||hypoglycemic episodes per 30 days||Standard Deviation|Mean
1418758|NCT01109316|Secondary|Percentage of Participants With Hypoglycemia|"Hypoglycemia was defined as an event which was associated with~reported signs and symptoms of hypoglycemia, and/or~a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L)."|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.|||percentage of participants|||Number
1418759|NCT01109316|Secondary|Pump Complication Rate Per 30 Days|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||pump complications per 30 days||Standard Deviation|Mean
1418760|NCT01109316|Secondary|Percentage of Participants With Pump Complications|Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.|||percentage of participants|||Number
1418761|NCT01109316|Secondary|Hyperglycemic Episode Rate Per 30 Days|Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||hyperglycemic episodes per 30 days||Standard Deviation|Mean
1418762|NCT01109316|Secondary|Percentage of Participants With Hyperglycemia|Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating.|8 weeks for each treatment|All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.|||percentage of participants|||Number
1418766|NCT01109316|Secondary|Mean SMBG|Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.|8 weeks for each treatment|All randomized participants who completed at least one post-randomization visit and one SMBG measurement on Day 2 for insulin lispro 2 day or Day 6 for the respective treatment arm: insulin lispro 6 day and insulin aspart 6 day.|||mmol/L||Standard Deviation|Mean
1418767|NCT01109316|Primary|Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use||8 weeks of each treatment|All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1418768|NCT01109173|Secondary|Percentage of Patients Pain-Free at Day 14|Ocular pain as assessed by the investigator on a scale ranging from 0 (none) to 5 (severe). Pain-free was defined as a score of 0 on the investigator's assessment of ocular pain.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.|||percentage of participants|||Number
1418769|NCT01109173|Primary|Percentage of Patients Cured at Day 14|Ocular inflammation was assessed by the investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (> 30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe – very dense flare). To be considered cured, the patient must have had a score of 0 for both cells and flare.|Day 14|All randomized patients with at least one postoperative assessment (ITT), last observation carried forward.|||percentage of participants|||Number
1418770|NCT01109147|Primary|Identification of Brain Circuits Involved in a Task of Emotional Congruence (With fMRI)|"During the fMRI session, the activation of each brain circuits is measured by a Bold signal (an arbitrary measure of contrast: numbers of voxels highlighted/activated in the region of interest).~The emotional task is composed by congruent and incongruent images. Three effects were caused by the task: congruence, attention and valence effects. Each of them affect, involve and activate the regions of interests differentially within the differents arms.~The region of interests who were mainly observed are: Anterior Cingulate Cortex (ACC), Prefrontal dorso-lateral Cortex (PFdlC) and the Amygdala (A)."|3 days after the decision of inclusion||||arbitrary units of activation||Standard Error|Mean
1418771|NCT01109147|Secondary|Investigate the Level of Expression of Candidate Genes||one blood sample|||||||
1418772|NCT01109147|Secondary|Assessment of Personality Traits||3 days after the decision of inclusion|||||||
1418773|NCT01109147|Secondary|Assessment of Cognitive and Attentional Abilities||3 days after the decision of inclusion|||||||
1418774|NCT01109147|Secondary|Assessment of Emotional Reactivity||3 days after the decision of inclusion|||||||
1418775|NCT01109108|Primary|Nasopharngeal Colonization With PCV13 S. Pneumoniae|Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae|Study years 1-5|Children colonized with any S. pneumoniae (PCV and non-PCV serotypes)|||Participants|||Count of Participants
1418776|NCT01109056|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16|Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Week 16|Modified Intent to Treat: All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia|||Scores on a Scale||Standard Deviation|Mean
1418777|NCT01109056|Primary|Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16|Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening.|Baseline, Week 16|"Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"|||Scores on a Scale||Standard Deviation|Mean
1418778|NCT01109056|Primary|Number of Pterygium Hyperemia Responders at Week 16|Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.|Week 16|"Modified Intent to Treat:~All randomized patients who received study treatment and had a baseline and at least one post-baseline assessment of pterygium hyperemia"|||Participants|||Number
1418779|NCT01109004|Secondary|MOS SF-36 Mental Component Summary|The Medical Outcome Study (MOS) SF-36 Mental Component Summary is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Deviation|Mean
1418780|NCT01109004|Secondary|MOS SF-36 Physical Component Summary|The Medical Outcome Study (MOS) SF-36 Physical Component Summary is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Deviation|Mean
1418781|NCT01109004|Secondary|FACT-BMT Trial Outcome Index|The Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index is a quality of life instrument that assesses the impact of bone marrow transplantation (BMT) on a patient's physical and functional well-being while taking into consideration BMT-specific concerns. The assessment has 24 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-96, with higher scores indicating higher levels of overall well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Error|Mean
1418782|NCT01109004|Secondary|FACT-BMT Score|The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Error|Mean
1418783|NCT01109004|Secondary|FACT-G Total Score|The Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life instrument that assesses the effects of cancer therapy on a patient's physical, social/family, emotional, and functional well-being. The assessment has 27 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-108, with higher scores indicating higher levels of overall well-being.|Up to 3 years post-randomization|Outcomes are analyzed from participants that were alive, progression-free, and completed assessments.|||score on a scale||Standard Error|Mean
1418784|NCT01109004|Secondary|Number of Participants With Treatment Response|"The number of participants with very good partial response (VGPR) or better [complete response (CR), near CR (nCR), and stringent CR (sCR)] according to the International Uniform Response Criteria will be calculated. The Worse than VGPR group includes PR, stable disease, and progressive disease.~sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: < 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR >=90% reduction in serum PPN plus urine PPN <100 mg/24hrs, >= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either >= 90% or to <200 mg/24 hours in light chain disease, >= 50% reduction in the size of soft tissue plasmacytomas"|1 and 2 years post-randomization|Only participants that were evaluable for disease response were analyzed at each time point. Those who had died or experienced disease progression were excluded.|||Participants|||Count of Participants
1418785|NCT01109004|Secondary|Percentage of Participants With Treatment-related Mortality (TRM)|TRM is defined as death prior to progression of multiple myeloma. To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating disease progression as a competing risk.|Up to 38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
1418786|NCT01109004|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival is defined as survival of death from any cause. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate overall survival at 38 months post-randomization.|38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
1418787|NCT01109004|Secondary|Percentage of Participants With Disease Progression|"Disease Progression is defined as progression of multiple myeloma, including one or more of the following:~A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL~24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours~Abnormal free light chain levels of >10 mg/dl, only in patients without measurable paraprotein in the serum and urine~At least 10% plasma cells in a bone marrow aspirate or on trephine biopsy~Definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of new bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum Ca >11.5 mg/dL or >2.8 mmol/L) not attributable to any other cause~To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk."|38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
1418788|NCT01109004|Primary|Percentage of Participants With Progression-free Survival (PFS)|Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.|38 months post-randomization||||percentage of participants||95% Confidence Interval|Number
1418789|NCT01108835|Secondary|Exercise Capacity|Exercise capacity was measured by change in 6 minutes walk test distance from baseline to 12 month. 6 minute walk test is the distance that the patient can walk over 6 minutes and it can range to 0 meters to few hundred meters. This was calculated by the 12 month 6 minutes walk test distance minus that of the baseline. Positive values indicated improvement in exercise capacity.|12 month||||meters||Standard Deviation|Mean
1418790|NCT01108835|Secondary|Lung Function|Measurement of change of spirometry (FEV1 % predicted) from baseline to 12 month. The range is from 0% to 100%. The change was calculated by 12 month value minus the baseline value. Positive value indicated improvement in lung function.|12 months|Percentage of predicted FEV1|||Percentage of Predicted FEV1||Standard Deviation|Mean
1418791|NCT01108835|Secondary|Mortality|From contacting the patient/their family and hospital record retrieval.|12 months||||participants|||Number
1418792|NCT01108835|Secondary|Quality of Life|Measured by change in St. George Respiratory Questionnaire (SGRQ) total score from baseline to 12 month. SGRQ total score ranged from 0-100. The change was calculated by the 12 month SGRQ total score minus the baseline value. Negative values indicated improvement in quality of life.|12 months||||units on a scale||Standard Deviation|Mean
1418793|NCT01108835|Primary|Hospital Readmission|To investigate the effectiveness of a comprehensive care programme in reducing hospital admission in COPD patients who have been discharged from hospital for an episode of AECOPD.|12 months||||hospital readmissions||Standard Deviation|Mean
1418794|NCT01108809|Secondary|Number of Patients With Adverse Events (AE)||6 months|Treated patients|||Number of participants|||Number
1418795|NCT01108809|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (6 months)|Patients with data at 3rd visit|||Number of participants|||Number
1418796|NCT01108809|Secondary|Change in Heart Rate From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||beats / minute||Standard Deviation|Mean
1418798|NCT01108809|Secondary|Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|Visit 3 (6 months from baseline)|Patients with data at 3rd visit|||Percentage of participants|||Number
1418799|NCT01108809|Primary|Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End|ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||Percentage of participants|||Number
1418800|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||Percentage of participants|||Number
1418801|NCT01108809|Primary|Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)|From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||Percentage of participants|||Number
1418802|NCT01108809|Primary|Change in Diastolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||mmHg||Standard Deviation|Mean
1418803|NCT01108809|Primary|Change in Systolic Blood Pressure From Baseline to Study End||From baseline to visit 3 (6 months)|Patients with data both at baseline and on 3rd visit|||mmHg||Standard Deviation|Mean
1418804|NCT01108796|Secondary|Assessment of Metabolic Effect|Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'|24 weeks (Visit 1 to Visit 3)||||Participants|||Number
1418805|NCT01108796|Secondary|Changes in Laboratory Parameters: Blood Glucose|Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
1418806|NCT01108796|Secondary|Changes in Laboratory Parameters: Triglycerides|Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
1418807|NCT01108796|Secondary|Changes in Laboratory Parameters:High Density Lipoprotein (HDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
1418808|NCT01108796|Secondary|Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)|Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmol/l||Standard Deviation|Mean
1418809|NCT01108796|Primary|Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmHg||Standard Deviation|Mean
1418810|NCT01108796|Primary|Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline|Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool|24 weeks (Visit 1 to Visit 3)||||mmHg||Standard Deviation|Mean
1418811|NCT01108757|Primary|Number of Participants With Urinary Tract Infection|Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as >100,000 colony forming units/mL|7 days following catheter removal|Study terminated early.|||Participants|||Count of Participants
1418812|NCT01108731|Secondary|Change in Widespread Pain|Pain was assessed using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst pain ever). The baseline value recorded was widespread pain at the time of assessment and the 2 months follow value recorded was widespread pain over the week prior to assessment.|2 months|Data from all 26 participants were used for analysis.|||units on a scale||Standard Deviation|Mean
1418813|NCT01108731|Secondary|Change in Cognitive Function Assessed by the no Cue Condition of the Attention Network Test (ANT).|The Attention Network Test (ANT) is a computerized test designed to evaluate the efficiency of the attention network. The ANT consists of a set of cued reaction time tasks to assess vigilance and efficiency to detect novel visual stimuli. The ANT also includes a set of flanker tasks during which a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Scores on the cued reaction time tasks (no cue, centre cue, double cue) reflect latency to respond measured in milliseconds (slower performance equals greater values). The score on the flanker task reflecting executive attention is derived by subtracting obtained latencies on the congruent flanker from the incongruent condition. Based on our prior work, we are hypothesizing that drug treated Ss will show improved performance on the no cue reaction time condition and on the derived executive attention variable compared to placebo treated.|Baseline and 2 months|Data from 4 were excluded due to 2 having error rates greater than 50%, indicating that they did not understand the task and 2 having simple reaction times longer than those for the complex reaction times on the ANT, suggesting their need for additional practice trials on the simple motor reaction time task.|||latency to respond (msecs.)||Standard Deviation|Mean
1418814|NCT01108731|Primary|Change in Ventricular Lactate Levels in the Brain|Ventricular lactate levels will be assessed before and at the end of the trial using a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.|Baseline and 2 months|One drug treated and two placebo treated could not be analyzed due to excessive head motion|||international units (iu)||Standard Deviation|Mean
1418815|NCT01108718|Primary|Mattress Preference of Fibromyalgia Patients|Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.|6 months|Following 2 months use of each test mattress, the study patients' sleep patterns and severity of fibromyalgia symptoms were assessed. At the end of the study, study patients were asked to rate each mattress in order of preference.|||percentage of study participants|||Number
1418816|NCT01108523|Secondary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 4, 8, and 12. Proportion of Subjects With no Denuded Skin Area at Day 4, 8, 12, and 15. Pre- and Post-Treatment Surveys||4, 8, 12, and 15 days|||||||
1418817|NCT01108523|Primary|Rating Scores of Skin Erythema, Skin Pallor, Skin Maceration, Skin Denudation at Day 15.||15 Days|||||||
1418818|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 192||Baseline to Week 192|Participants in the ITT Analysis Set with available change data at Week 192 were analyzed.|||cells/μL||Standard Deviation|Mean
1418819|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 144||Baseline to Week 144|Participants in the ITT Analysis Set with available change data at Week 144 were analyzed.|||cells/μL||Standard Deviation|Mean
1418820|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline to Week 96|Participants in the ITT Analysis Set with available change data at Week 96 were analyzed.|||cells/μL||Standard Deviation|Mean
1418821|NCT01108510|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.|||cells/μL||Standard Deviation|Mean
1418822|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm.|Week 192|Week 192 Modified ITT Analysis Set: includes participants in the ITT analysis set excluding those who either (1) transferred to other Gilead-sponsored studies after completing their Week 144 visit and before the lower limit of the Week 192 analysis window, or (2) prematurely discontinued study drug prior to the Week 144 visit.|||percentage of participants|||Number
1418823|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm.|Week 144|ITT Analysis Set|||percentage of participants|||Number
1418824|NCT01108510|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1418825|NCT01108510|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Intent-to-Treat (ITT) Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1418826|NCT01108458|Secondary|Proportion of Participants With 50% Decrease in Tumor Marker|Change in tumor marker CA19-9, assessed as a 50% decrease from baseline|3 weeks|||||||
1418827|NCT01108458|Secondary|No. of Events of Drug-related Toxicity|Number of incidences of serious and non-serious drug-related adverse events|3 weeks||||Drug-related adverse events|||Number
1418828|NCT01108458|Secondary|Quality of Life (QoL)|Quality of life as assessed by EORTC QLQ-C30 questionnaire|3 weeks|||||||
1418829|NCT01108458|Secondary|Overall Survival (OS)||1 year|||||||
1418830|NCT01108458|Secondary|Progression-free Survival (PFS)|"Disease status evaluated by computed tomography (CT) scan and progression-free survival assessed per RECIST criteria.~Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported."|9 weeks|||||||
1418831|NCT01108458|Primary|Overall Response Rate by RECIST Criteria||CT imaging every 9 weeks while on protocol|||||||
1418832|NCT01108445|Other Pre-specified|Changes in Copy Number, RNA Expression, and Immunohistochemical Profiles|To evaluate in an exploratory fashion changes in copy number, RNA expression, and immunohistochemical profiles by microarray between primary non-clear cell RCC tumors and metastatic samples|36 months|||||||
1418833|NCT01108445|Other Pre-specified|Clinical Measures of Response and PFS With Baseline and Time-dependent Levels of Biomarkers|To correlate clinical measures of response and PFS with baseline and time-dependent levels of biomarkers. These biomarkers include plasma angiokine levels, tissue immunohistochemical and genomic profiles, copy number as assessed by array-based comparative genomic hybridization (CGH), and known mutations in non-clear cell RCC|36 months|||||||
1418834|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and end of treatment per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, up to 40 months|All participants who completed the End of treatment visit.|||units on a scale||Standard Deviation|Mean
1418864|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented.|Day 0|The per-protocol population was analyzed.|||Participants|||Number
1418835|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 6 day1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 6 day 1|All participants who completed the cycle 6 day 1 visit.|||units on a scale||Standard Deviation|Mean
1418836|NCT01108445|Secondary|Change in Quality-of-life|To compare change in quality-of-life, as measured by the FACT-KSI scale at baseline and cycle 3 day 1 per subject in each treatment arm. Functional Assessment of Cancer Therapy Kidney Symptom Index. FKSI is a questionnaire for FACT–Kidney Symptom Index used to assess QoL/participant-reported outcomes for participants diagnosed with renal cell cancer. The FKSI contained 15 questions each ranging from 0 (not at all) to 4 (very much) so that FKSI ranged between 0-60 where higher scores reflects better functioning and fewer symptoms.|baseline, cycle 3 day 1|All participants who completed the cycle 3 day 1 visit.|||units on a scale||Standard Deviation|Mean
1418837|NCT01108445|Secondary|Percentage of Participants With Adverse Events|To assess toxicities associated with everolimus or sunitinib using NCI CTC version 4.0 criteria|24 months||||percentage of participants||95% Confidence Interval|Number
1418838|NCT01108445|Secondary|Time-to-new Metastatic Disease in Each Treatment Arm|To compare the time-to-new metastatic disease in each treatment arm, defined from the date of first study agent administration to the onset of a new evaluable site of disease, excluding the primary site and all sites documented at baseline|36 months||||months||95% Confidence Interval|Median
1418839|NCT01108445|Secondary|Median OS|To compare the median OS in each treatment arm.|Up to 40 months||||months||95% Confidence Interval|Median
1418840|NCT01108445|Secondary|Median Duration of Response (CR, PR, and SD)|To compare the median duration of response (CR, PR, and SD) in each treatment arm. According to RECIST 1.1, Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|24 months||||months||Inter-Quartile Range|Median
1418841|NCT01108445|Secondary|Best Tumor Shrinkage as a Percentile in Each Arm|To compare the best tumor shrinkage as a percentile in each treatment arm. The percentile change at each follow up visit is calculated by measuring the percentage change in the Sum of lesion measurement from baseline. The best tumor shrinkage is lowest percentile change. A decrease is indicated by a negative percentage.|24 months||||percentile decrease||Inter-Quartile Range|Median
1418842|NCT01108445|Secondary|Overall Survival Rates|To compare overall survival (OS) rates at 6, 12, 24, and 36 months and over time in each treatment arm.|6, 12, 24, 36 months||||percentage probability||95% Confidence Interval|Number
1418843|NCT01108445|Secondary|12 Week Clinical Benefit Rate as Percentage|Rate of complete or partial response or stable disease by the RECIST 1.1 criteria lasting ≥ 12 weeks prior to progression. Benefit rate is defined as complete response [CR] and partial response [PR] and stable disease [SD] by RECIST 1.1 criteria in each treatment arm. Benefit rate = CR + PR + SD. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months||||percentage of particpants||95% Confidence Interval|Number
1418844|NCT01108445|Secondary|Percentage of Participants With Stable Disease (SD)|Percentage of participants with stable disease during treatment is defined as stable disease [SD] by RECIST 1.1 criteria as calculated in each treatment arm. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to 36 months||||percentage of participants||95% Confidence Interval|Number
1418845|NCT01108445|Secondary|Overall Response Rate|Defined as complete response [CR] and partial response [PR] by RECIST 1.1 criteria in each treatment arm.Overall Response Rate (ORR) = CR + PR. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|24 months||||percentage of participants||95% Confidence Interval|Number
1418846|NCT01108445|Secondary|PFS Expressed in Months|Progression-free survival (PFS) expressed in months as compared to an historic control (interferon-treated clear cell RCC control arm from the sunitinib phase III study). Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 months||||Months||95% Confidence Interval|Median
1418847|NCT01108445|Secondary|Progression Free Survival Rates|6-, 12-, and 24-month rates of PFS in each arm will be compared for each treatment arm. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|6, 12 and 24 months||||percentage of participants||95% Confidence Interval|Number
1418865|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.|||Percentage|||Number
1430834|NCT01002339|Secondary|Proteinuria||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/day||95% Confidence Interval|Mean
1418848|NCT01108445|Primary|Anti-tumor Activity as Measured by Median Progression Free Survival Time|The primary objective will be to compare the anti-tumor activity of everolimus and sunitinib in subjects with mRCC with non-clear cell pathology, as measured by progression-free survival (PFS) following treatment initiation according to RECIST 1.1 criteria. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|24 Months||||Months||80% Confidence Interval|Median
1418849|NCT01108406|Secondary|Measurement of Device Benefit With the Abbreviated Profile of Hearing Aid Benefit (APHAB)|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) , a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. Software is used to score the APHAB and results are compared from the different timepoints. The APHAB is well characterized and broadly used as a quantifiable measurement. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment).|3 months and 6 months||||Global Benefit Score||Standard Deviation|Mean
1418850|NCT01108406|Primary|Long Term Safety|The safety outcomes were defined as no changes in medical, auditory, or dental status and no device or procedure related adverse events during the study period. Safety was evaluated by conducting a Comprehensive Medical evaluation at Enrollment and at study termination; Comprehensive Dental evaluation at Enrollment and at 3 and 6 months, with interim dental checks in between if necessary and Comprehensive Audiological evaluation at Enrollment and at 6 months.|6 months||||participants|||Number
1418851|NCT01108341|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|up to Week 32|Safety population of participants who were treated|||percentage of participants||95% Confidence Interval|Number
1418852|NCT01108341|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR), as Determined by the International Working Group (IWG) Criteria As Assessed by Investigators|The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|up to Week 32|Safety population of participants who were treated|||percentage of participants||95% Confidence Interval|Number
1418853|NCT01108263|Secondary|Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.||12 weeks||||participants|||Number
1418854|NCT01108263|Primary|Overall Decrease in Wound Size||12 weeks||||participants|||Number
1418855|NCT01108237|Secondary|Sagittal Component Alignment||Pre-Op, 3 months|||||||
1418856|NCT01108237|Secondary|Compare AP Tibial/Femoral Component Alignment||Pre-op, 3 months|||||||
1418857|NCT01108237|Secondary|Compare Intraoperative Time Data (Skin-to-skin, Tourniquet, Tourniquet to Bone)||During the Procedure|||||||
1418858|NCT01108237|Primary|Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films|Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.|12 weeks postoperatively (when subject has reached full knee extension)||||Absolute value in degrees||Standard Deviation|Least Squares Mean
1418859|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized.|Day 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
1418860|NCT01108185|Secondary|Auscultation|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized.|Day 0|The per-protocol population was analyzed.|||Participants|||Number
1418861|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented.|Day 10 - 16||||Participants|||Number
1418862|NCT01108185|Secondary|Dyspnoea|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented.|Day 0|The per-protocol population was analyzed.|||Participants|||Number
1418863|NCT01108185|Secondary|Cough and Its Character|Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented.|Day 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
1418866|NCT01108185|Secondary|Body Temperature|Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized.|Day 0|The per-protocol population was analyzed.|||Percentage|||Number
1418867|NCT01108185|Primary|The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events|The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.|Day 0 through Days 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
1418868|NCT01108185|Primary|Compliance (Was the Dosage Followed - Yes, no)|Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.|Day 10 - 16|The per-protocol population was analyzed.|||Participants|||Number
1418869|NCT01108081|Secondary|Change Over 6 Months in Quality of Life|Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Functional Outcomes of Sleep Questionnaire scores. One participant in Diet arm and one participant in Health education arm.|||units on a scale||Standard Error|Mean
1418870|NCT01108081|Primary|Change Over 6 Months in Epworth Sleepiness Scale Score|Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.|baseline and 6 months|Two participants did not complete the questionnaire and therefore had missing Epworth Sleepiness Scale scores. One participant in Diet arm and one participant in Health education arm.|||units on a scale||Standard Error|Mean
1418871|NCT01108068|Secondary|pQCT Z-score in OPPG Participants at Baseline and 6 Months After Lithium|"The Z-score indicates the number of standard deviations away from the mean of age matched controls. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-score indicates a favorable outcome.Z-score of pQCT variable was noted for the in two OPPG participants who received lithium and were also able to get pQCT scans. The n of 2 was too small to do statistical analyses. Of the 5 OPPG who were on lithium, 2 were too small for the machine (eventhough over age 4) and 1 had rods in his legs and couldn't have pQCT"|baseline, 6 months|Two OPPG participants who took lithium for 6 months and were able to do pQCT at baseline and 6 months. First number is baseline, 2nd number is 6 months for section modulus|||Z-score||Standard Deviation|Mean
1418872|NCT01108068|Primary|pQCT of Lower Leg|pQCT will be done at baseline for all OPPG participants and unaffecteds. The Z-score indicates the number of standard deviations away from the mean of age matched controls. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher. A positive change in Z-score indicates a favorable outcome.|Baseline|in OPPG, 2 were too small for pQCT machine and 2 had hardware in legs. For 2 in unaffecteds there were technical difficulties with the pQCT scanner|||Z-score||95% Confidence Interval|Mean
1418873|NCT01108055|Secondary|Median Overall Survival (OS) by Bellmunt Score|"Comparison between the participant's baseline Bellmunt prognostic risk factor score and survival rates.~The Bellmunt prognostic risk factor score is a tool that is often used to predict treatment outcomes before initiating a secondline treatment regimen.~The risk factors used to calculate the Bellmunt score include:~Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1~Presence of liver metastases~Presence of visceral involvement (defined as liver, lung, bone or any non-lymph node)~Lymph node-only involvement~Hemoglobin concentration < 10 g/dL~The score is calculated based on the presence of 0; 1; 2; or 3 of the above prognostic factors. This outcome reports median overall survival based on whether the participant had 0; 1; 2; or 3 prognostic factors."|4 years|Include all 32 participants, regardless of completing 2 cycles of treatment.|||Months||Full Range|Median
1418874|NCT01108055|Secondary|Overall Survival|Overall survival is reported as the median survival of the evaluable subjects (ie, completed 2 cycles of treatment).|4 years|Does not include participants who did not complete 2 cycles of treatment.|||Months||95% Confidence Interval|Mean
1418875|NCT01108055|Secondary|Overall Response Rate|"The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:~Complete response (CR) = Disappearance of all target lesions~Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions~Stable disease (SD) = Small changes that do not meet above criteria Tumor response rate by each response criteria."|4 years|Does not include participants who did not complete 2 cycles of treatment.|||Participants|||Count of Participants
1418876|NCT01108055|Secondary|Progression-free Survival (PFS)||4 years||||Months||95% Confidence Interval|Median
1418877|NCT01108055|Primary|Objective Tumor Response|"The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:~Complete response (CR) = Disappearance of all target lesions~Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions~Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR)."|Every 8 weeks|The outcome is reported as subjects with CR (complete response) + PR (partial response).|||Participants|||Count of Participants
1418880|NCT01107964|Secondary|Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45|"Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability.~Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value)."|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||time in seconds|eyes|Inter-Quartile Range|Median
1418881|NCT01107964|Secondary|Change From Baseline of Lissamine Green Staining Score at Day 45|Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score)|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||units on a scale|eyes|Inter-Quartile Range|Median
1418882|NCT01107964|Secondary|Change From Baseline of Schirmer-1 Test Value at Day 45|Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value).|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||millimeters|eyes|Inter-Quartile Range|Median
1418883|NCT01107964|Primary|Change From Baseline of the Ocular Surface Disease Index Score at Day 45|The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)|Baseline and Day 45|Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.|||units on a scale|eyes|Inter-Quartile Range|Median
1418884|NCT01107925|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy|MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline , Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percent aggregation||Standard Deviation|Mean
1418885|NCT01107925|Secondary|Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)|A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|baseline (pre-dose) up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.|||nanogram•hour/milliliter (ng•hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
1418886|NCT01107925|Secondary|Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||P2Y12 reaction units (PRU)||Standard Deviation|Mean
1418887|NCT01107925|Secondary|Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy|VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.|Baseline, Day 12|As-treated pharmacodynamic (PD) population: all randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable PD measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percentage PRI||Standard Deviation|Mean
1418888|NCT01107925|Primary|Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)|MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|Primary intent-to-treat (ITT) pharmacodynamic (PD) population: all randomized participants who continued in the study through Day 12, and had at least 1 evaluable PD assessment at Day 12. Participants were analyzed based on the treatment group they were randomized to irrespective to the treatment they received.|||percent aggregation||Inter-Quartile Range|Median
1419842|NCT01099761|Secondary|Change in Pulmonary Function Tests (FVC)|Forced Vital Capacity (FVC); 1 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Study Visit, approximately 24 weeks later.||||Liters||Standard Deviation|Mean
1418889|NCT01107912|Secondary|Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percentage of aggregation||Standard Deviation|Mean
1418890|NCT01107912|Secondary|Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing|A descriptive pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing prasugrel and clopidogrel active metabolite exposures to MPA in response to 20 µM ADP (by LTA) was conducted as originally intended; however, the graphic output from that analysis is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours [AUC (0-4)] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.|Baseline up to 4 hours post-dose|All available PK sample data from all treated participants who contributed complete PK profiles.|||nanogram*hour/milliliter (ng*hr/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
1418891|NCT01107912|Secondary|Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy|The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in P2Y12 reaction units (PRU). PRU report the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of the rate and extent of platelet aggregation in the presence of adenosine phosphate ADP. A lower PRU reflects stronger inhibition of P2Y12, whereas a higher PRU reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||P2Y12 reaction units (PRU)||Standard Deviation|Mean
1418892|NCT01107912|Secondary|Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy|Vasodilator-associated stimulated phosphoprotein (VASP) phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12, whereas a higher PRI reflects weaker inhibition of P2Y12.|Baseline, Day 12|All randomized participants who received at least 1 dose of study drug and provided at least 1 evaluable pharmacodynamic (PD) measure at 1 of the 3 periods. Participants were analyzed based on the treatment they received for each period regardless of their randomized treatment assignment.|||percentage platelet reactive index (PRI)||Standard Deviation|Mean
1418893|NCT01107912|Primary|Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period|Maximum Platelet Aggregation (MPA) to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). Lower MPA values reflect stronger platelet inhibition, whereas higher MPA values reflect weaker inhibition.|Baseline, 12 days|All randomized participants who continued in the study through the Day 12 visit, and who had at least 1 evaluable PD assessment at the Day 12 visit. Participants were analysed based on randomized treatment assignment, regardless of the study drug they took.|||percentage of aggregation||Inter-Quartile Range|Median
1418894|NCT01107899|Secondary|Platelet Function by Multiplate® ADP Test and ADP Test HS|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM PGE1 (ADP test HS), area under the aggregation curve (AUC) were calculated.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.|||aggregation units*minute||Standard Deviation|Mean
1418895|NCT01107899|Secondary|Platelet Function by LTA at 5 and 20 μM ADP|MPA to 5 and 20 μM ADP were assessed by LTA.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.|||percent aggregation||Standard Deviation|Mean
1418896|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by Multiplate® ADP Test and ADP Test High Sensitivity (HS)|The Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. After adding 6.4 µM ADP (ADP test) or 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADP test HS), area under the aggregation curve (AUC) was calculated. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
1418897|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hours Post-LD) by LTA (5 and 20 μM ADP)|Maximum platelet aggregation (MPA) to 5 and 20 μM ADP were assessed by LTA. This outcome measure was not analyzed due to limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
1418909|NCT01107886|Secondary|Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation|Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.|||participants|||Number
1418898|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)|Return of baseline platelet function was assessed by Multiplate® ADP test and ADP test High Sensitivity (HS). Multiplate analyzer was used to assess platelet aggregation based on impedance aggregometry in whole blood. The agonist ADP was added to stirred whole blood after dilution (1:2 with 0.9% NaCl solution) in a final concentration of 6.4 µM (ADP Test) or in final concentration of 6.4 µM ADP plus 9.4 nM Prostaglandin E1 (PGE1) (ADPtest HS). Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve (AUC=AU*min) of aggregation units (AU).|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.|||Aggregation Units * minutes||90% Confidence Interval|Mean
1418899|NCT01107899|Secondary|Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)|Initial inhibition of platelet aggregation was measured by LTA at 5 and 20 μM ADP. Maximum platelet aggregation (MPA) is reported by day.|Up through 11 days|ITT Washout Population: All randomized participants who received the study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD.|||percent platelet aggregation||90% Confidence Interval|Mean
1418900|NCT01107899|Secondary|Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD|Platelet aggregation was assessed by Accumetrics Verify Now™ P2Y12, and poor responders were those with PRU greater than or equal to 230.|24 hours post-loading dose|LD ITT Population: All randomized participants who received an LD with evaluable PD measurements.|||percentage of participants|||Number
1418901|NCT01107899|Secondary|Platelet Function 24 Hours Post Loading Dose|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of ADP-stimulated platelet aggregation.|24 hours post-loading dose|LD ITT population: All randomized participants who received an LD with evaluable PD measurements 24 hours post-LD.|||P2Y12 Reaction Units (PRU)||Standard Deviation|Mean
1418902|NCT01107899|Secondary|Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU|PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
1418903|NCT01107899|Secondary|Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU|To show effect of initial inhibition of platelet aggregation as measured by Accumetrics Verify Now™ P2Y12 on the day to return to baseline platelet function, a regression model was fitted with day to return as outcome variable and initial inhibition as fixed effect. Results are reported as the predicted day to return to baseline platelet function by derived VN-PRU percent (%) inhibition at 24 hours post LD. The derived VN-PRU % inhibition is calculated as a percent decrease of PRU from baseline using the following formula: ([PRU at baseline - PRU at 24 hours post LD]/PRU at baseline) x 100%.|Up through 11 days|ITT Washout Population: All randomized participants who received study drug LD, had an evaluable baseline PD measurement (pre-LD), and had at least 1 evaluable PD measurement post-LD. One participant discontinued on Day 3 without returning to baseline and is not included in analysis.|||days|||Number
1418904|NCT01107899|Secondary|Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)|The return of baseline platelet function following one LD of prasugrel (30 mg or 60 mg) or 600 mg LD of clopidogrel assessed by Verify Now™ P2Y12 Reaction Units (VN-PRU). This outcome measure was not analyzed because it was not appropriate to estimate the days based on the non-inferiority approach due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days||Standard Deviation|Mean
1418905|NCT01107899|Secondary|The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7|The day at which the proportion of participants who return to baseline platelet P2Y12 receptor function in the prasugrel 30 mg and 60 mg LD groups is similar (within 10% absolute difference) to the proportion of subjects who return to baseline platelet P2Y12 receptor function at day 5 and day 7 in the clopidogrel 600 mg LD group, obtained from Kaplan Meier curves for the primary washout population, was to be presented. This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||day|||Number
1418906|NCT01107899|Secondary|The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel|This outcome measure was not analyzed due to the limited sample size.|Up through 11 days|Since this outcome measure was not analyzed due to the limited sample size, zero participants were included in the analysis.|||days|||Number
1418907|NCT01107899|Primary|Percentage of Participants Returning to Baseline Platelet Function|Participants were classified as having platelet function return to baseline after loading dose (LD) on the first day that P2Y12 Reaction Units (PRU) was no more than 60 PRU below baseline and remained in this range. PRU was assessed by Accumetrics Verify Now™ P2Y12. PRU represents the rate and extent of adenosine diphosphate (ADP)-stimulated platelet aggregation.|Days 3, 5, 7, 9, and 11|Primary Washout Population: Included participants who completed the study, had evaluable pharmacodynamic (PD) data through Day 11. Participants with a missed visit were not included in the Primary Washout Population.|||percentage of participants|||Number
1418908|NCT01107886|Secondary|Participants With Event of Death|Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.|||participants|||Number
1418994|NCT01107418|Secondary|Overall Survival (OS)|OS was defined as the time, in months, from the date of the first study drug administration to the date of death, regardless of the cause of death.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
1418910|NCT01107886|Primary|Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke|Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)—whichever was later.|Randomization (day 0) up to 2.9 years|Intention To Treat (ITT) analysis of randomized population. Events were adjudicated by the Clinical Event Adjudication Committee.|||participants|||Number
1418911|NCT01107834|Secondary|Myocardial Wall Velocity During Early Diastole|Myocardial wall velocity during early diastolemeasured by tissue Doppler imaging|Baseline||||cm/s||Standard Error|Mean
1418912|NCT01107834|Secondary|Early to Late Diastolic Filling Ratio|Early to late diastolic filling ratio measured by tissue Doppler echocardiography|Baseline||||ratio, unitless||Standard Deviation|Mean
1418913|NCT01107834|Secondary|Systolic Myocardial Velocity During Systole (S')|Systolic myocardial velocity during systole measured by tissue Doppler echocardiography|Baseline||||cm/s||Standard Deviation|Mean
1418914|NCT01107834|Secondary|Global Strain Rate|Myocardial deformation (a measure of heart contractility) measured by speckel tracking echocardiography|Baseline||||percentage of full deformation||Standard Deviation|Mean
1418915|NCT01107834|Primary|Fractional Shortening|Fractional shortening measured by M-mode cardiography|Baseline||||percentage of full contraction||Standard Deviation|Mean
1418916|NCT01107834|Primary|Left Ventricular Mass Index|left ventricular mass index measured by 2D echocardiography|Baseline||||g/m2||Standard Deviation|Mean
1418917|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418918|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418919|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418920|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418921|NCT01107743|Secondary|Risk Factor for the Proportion of Responders of Amlodipine/Atorvastatin Combination Tablets for Hypercholesterolemia or Familial Hypercholesterolemia - Hypercholesterolemia Expression Type.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418922|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418923|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypercholesterolemia or Familial Hypercholesterolemia -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418924|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1419013|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 3 (initial challenge)|Visit 3 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
1418925|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina Pectoris is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418926|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418927|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418928|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Angina Pectoris Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Angina Pectoris functional classification Severity, Class1, Class2, Class3, or Class4 is significant risk factor for Angina Pectoris. Angina Pectoris functional classification Severity is defined by Canadian Cardiovascular Society functional Classification of Angina."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418929|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418930|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Angina Pectoris -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418931|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Concomitant Drugs.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Concomitant Drugs is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418932|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Complications.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418933|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Renal Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418934|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hepatic Dysfunction.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418935|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Hypertension Severity.|"Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor for Hypertension. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418936|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Age.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418937|NCT01107743|Secondary|Risk Factors for the Proportion of Responders for Hypertension -Gender.|Number of Participants with responders of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1419181|NCT01106157|Secondary|Change in Insulin Requirements, Baseline to 12 Months|Change in Insulin Requirements, baseline to 12 months|Change from baseline to 12 months|Insulin use data was not provided by all subjects resulting in sampling for analysis that was smaller than the cohort for the entire study.|||units/kg/day||Standard Deviation|Mean
1418938|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Concomitant Drugs.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Concomitant Drugs is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418939|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Complications.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Complications is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418940|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Renal Dysfunction.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Renal Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418941|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hepatic Dysfunction.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hepatic Dysfunction is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418942|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Familial Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Familial Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418943|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia Expression Type.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypercholesterolemia expression type, Ⅰ, Ⅱa, Ⅱb, Ⅲ, Ⅳ, or Ⅴ is significant risk factor. Hypercholesterolemia expression types are defined by Japan Atherosclerosis Society Guideline for Prevention of Atherosclerosis Cardiovascular Diseases."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418944|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypercholesterolemia.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypercholesterolemia is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418945|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Angina Pectoris.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Angina pectoris is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418946|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension Severity.|"Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether Hypertension severity, ClassⅠ, ClassⅡ, or ClassⅢ is significant risk factor. Hypertension severity is defined by Guideline for the Management of hypertension (The Japan Society of Hypertension)."|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418947|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Hypertension.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether with or without Hypertension is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418948|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Age.|Number of participants with Treatment Related Adverse Events (TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether <65 years or >=65 years is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418949|NCT01107743|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets -Gender.|Number of participants with Treatment Related Adverse Events(TRAEs) of Amlodipine/Atorvastatin Combination Tablets to determine whether male or female is significant risk factor.|8 weeks|The safety analysis population consists of the cases that satisfy the cases conditions and in whom administration of this drug was confirmed.|||participants|||Number
1419014|NCT01107405|Primary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Conjunctival Hyperemia Scores, ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||Units on a scale||Standard Deviation|Mean
1419182|NCT01106157|Secondary|A1c|Change in A1c baseline to 12 months|Change in baseline to 12 months||||% change||Standard Deviation|Mean
1418950|NCT01107743|Secondary|Number of Treatment Related Unlisted Adverse Events in Japanese Package Insert.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Number of Treatment Related Adverse Events were evaluated in company with the causal relationship to Caduet. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|8 weeks|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418951|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypercholesterolemia or Familial Hypercholesterolemia.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypercholesterolemia or Familial Hypercholesterolemia.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypercholesterolemia or Familial Hypercholesterolemia in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418952|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Angina Pectoris.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and enteterd the results for Angina Pectoris.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Angina Pectoris in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418953|NCT01107743|Primary|Number of Participants That Responded to Amlodipine/Atorvastatin Treatment With Hypertension.|The physician performed efficacy evaluations at the end of the observation period (or the time of discontinuing administration), compared with the data before the start of administration of this drug, and entered the results for Hypertension.|8 weeks|The efficacy analysis population basically consists of the evaluable cases with Hypertension in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1418954|NCT01107743|Primary|Number of Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in patients after administration of Caduet, irrespective of causal relationship to Caduet (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Caduet.|8 weeks|The safety analysis population consist of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1418955|NCT01107730|Primary|Incidence of Postoperative Atrial Fibrillation|The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.|Within the first 30 days (plus or minus 3 days)||||participants|||Number
1418956|NCT01107535|Secondary|Number of Serious Adverse Events|The number participants experiencing a serious adverse event. For additional information see the Reported Adverse Events section.|Enrollment until 100 days after the last Synagis (palivizumab) dose|Analysis included all enrolled participants.|||participants|||Number
1418957|NCT01107535|Secondary|Number of Ventilation Support Days (Supplemental Oxygen and Mechanical Ventilation) During the Hospital Admission|The mean (average) number of days participants required supplemental oxygen during any hospital stay and the mean number of days participants required mechanical ventilation while in the intensive care unit.|Hospital admission to hospital discharge|Analysis of supplemental oxygen included participants with any hospital stay during the study (n=10) and analysis of mechanical ventilation included the subgroup of participants with intensive care unit stays during the study (n=2).|||days||Standard Deviation|Mean
1418958|NCT01107535|Secondary|Number of Intensive Care Unit Days During the Hospital Admissions by Respiratory Syncytial Virus Infection|The number of days spent in a hospital intensive care unit (ICU) are summarized for those participants requiring that type of care. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|Hospital admission to hospital discharge|Two participants with a total of 3 intensive care unit stays were analyzed. One participant was negative for respiratory syncytial virus during their first stay in the intensive care unit and was positive for respiratory syncytial virus at their second stay.|||days|||Number
1418959|NCT01107535|Secondary|Number of Hospital Admission Days (All Causes)|The mean (average) number days participants were hospitalized.|Hospital admission to hospital discharge|Analysis included all participants who were hospitalized during the study. This includes 2 participants hospitalized due to respiratory syncytial virus infection and 8 participants hospitalized for other respiratory diseases.|||days||Standard Deviation|Mean
1418960|NCT01107535|Primary|Number of Hospital Admissions by Respiratory Syncytial Virus Infection|The number of participants hospitalized for respiratory syncytial virus infection from the first dose of study drug up to the visit coinciding with the first birthday of the participant. An indirect immunofluorescence test (a laboratory technique used to detect the presence of viruses) was used to determine if hospitalized participants had respiratory syncytial virus infection.|First year of life (up to 12 months)|Analysis included all enrolled participants.|||participants|||Number
1418961|NCT01107457|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|"The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant.~Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.|||units on a scale||Standard Deviation|Mean
1419015|NCT01107405|Primary|Ocular Itching|Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (8 hr re-challenge)|Visit 4, Re-challenge Ocular Itching Scores – Primary Analysis ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||Units on a Scale||Standard Deviation|Mean
1418962|NCT01107457|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 240|All enrolled participants who had PASI 75 response at Week 20.|||percentage of participants|||Number
1418963|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis|The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.|Baseline Up to 240 Weeks|All enrolled participants with baseline palmoplantar psoriasis.|||units on a scale||Standard Deviation|Mean
1418964|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis|"The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.~Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants with baseline scalp psoriasis.|||units on a scale||Standard Deviation|Mean
1418965|NCT01107457|Secondary|Change From Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis|"The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing.~Baseline is defined as the last available value prior to the first dose in Part A of the study."|Baseline Up to 240 Weeks|All enrolled participants with baseline nail psoriasis.|||units on a scale||Standard Deviation|Mean
1418966|NCT01107457|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used.|Baseline Up to 240 Weeks|All enrolled participants with data available.|||Millimeters (mm)||Standard Error|Mean
1418967|NCT01107457|Secondary|Number of Participants With Patient's Global Assessment of Disease Activity (PatGA)|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been)."|Week 240|All enrolled participants who had PASI 75 response at Week 20.|||Participants|||Count of Participants
1418968|NCT01107457|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS)|The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal.|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.|||units on a scale||Standard Deviation|Mean
1418969|NCT01107457|Secondary|Number of Treatment Emergent Adverse Events up to 344 Weeks|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline Up to 344 Weeks|All enrolled participants.|||Participants|||Count of Participants
1418970|NCT01107457|Secondary|Percentage of Participants With Static Physician's Global Assessment (sPGA) of (0,1)|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Baseline Up to 240 Weeks|All enrolled participants who had PASI 75 response at Week 20.|||percentage of participants|||Number
1418971|NCT01107457|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline through Week 20|All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline antibody assessment.|||percentage of participants|||Number
1418972|NCT01107457|Secondary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Week 32|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. Zero participants in the placebo arm had data.|||percentage of participants|||Number
1418973|NCT01107457|Secondary|Percentage of PASI Improvement From Baseline Through 32 Weeks|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.|Baseline Through 32 Weeks|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Zero participants in the placebo arm had data.|||Percentage PASI improvement||Standard Deviation|Mean
1418974|NCT01107457|Secondary|Percentage of Participants Who Achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 32|All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||percentage of participants|||Number
1418975|NCT01107457|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12|PASI combines the extent of body surface involvement in 4 anatomical regions(head,trunk,arms,and legs).For each region the percent area of skin involved was estimated from 0(0%) to 6(90%-100%) and severity was estimated by clinical signs of erythema,induration and scaling with a scores range from 0(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as:sum of severity parameters for each region*area score*weighing factor (head[0.1],upper limbs[0.2],trunk[0.3],lower limbs [0.4]).Overall scores range from 0(no psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418976|NCT01107457|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16|The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418977|NCT01107457|Secondary|Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab From Baseline Through 32 Weeks)|The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms.|Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||liters per hour (L/hr)||95% Confidence Interval|Mean
1418978|NCT01107457|Secondary|Change From Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants With Scalp Psoriasis at Week 12|The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline scalp involvement were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1418979|NCT01107457|Secondary|Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants With Palmoplantar Psoriasis at Week 12|The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with palmoplantar involvement were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1418980|NCT01107457|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants With Nail Psoriasis at Week 12|The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline nail involvement were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1418981|NCT01107457|Secondary|Change From Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418982|NCT01107457|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16|The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))*100, Presenteeism(impairment at work/reduced on-the-job effectiveness) = (Q5/10) *100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]) * 100 and Activity Impairment = (Q6/10) * 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418983|NCT01107457|Secondary|Number of Participants Who Received Medical Care Measured by Medical Care Resource Utilization (PMRU))|The PMRU is a 3‑item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit.|Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment.|||participants|||Number
1418984|NCT01107457|Secondary|Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16|MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute.The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418985|NCT01107457|Secondary|Change From Baseline in Pain Visual Analog Scale (VAS) at Week 12|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with self-reported psoriatic arthritis at baseline were included in the analysis. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||millimeter (mm)||95% Confidence Interval|Least Squares Mean
1418986|NCT01107457|Secondary|Change From Baseline in Patient Global Assessment (PatGA) at Week 12|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model."|Baseline, 12 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418987|NCT01107457|Secondary|Change From Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418988|NCT01107457|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16|The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate.|Baseline, Week 16|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1418989|NCT01107457|Secondary|Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline Up to 20 Weeks|All randomized participants who received at least 1 dose of study drug.|||Participants|||Number
1418990|NCT01107457|Secondary|"Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement at Week 12"|The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline.|Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||percentage of participants|||Number
1418991|NCT01107457|Primary|Percentage of PASI Improvement From Baseline to 12 Week Endpoint|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Least squares (LS) mean values were calculated using mixed model repeated measures (MMRM) and controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured.|Baseline to Week 12|All randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline PASI assessment.|||Percentage of improvement in PASI score||95% Confidence Interval|Least Squares Mean
1418992|NCT01107457|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||percentage of participants|||Number
1418993|NCT01107418|Primary|Accumulation Ratio of Vemurafenib on Day 15|Accumulation ratio was calculated as, AUC(0-8) on Day 15 divided by AUC(0-8) on Day 1.|Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1 and 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||ratio||Standard Deviation|Mean
1418995|NCT01107418|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response. Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) were required to demonstrate a reduction to normal (short axis less than [<] 10 millimeters [mm]). PR was defined as a 30 percent (%) decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of confirmed CR or PR are reported.|Up to approximately 3 years (assessed at Cycle 1 Day 1, Cycle 3 Day 1, Cycle 5 Day 1, thereafter every 2 cycles and then every 4 cycles after Cycle 13)|Efficacy population: all enrolled participants who received at least one dose of vemurafenib, had measurable target lesions at baseline based on RECIST 1.1 criteria, had no major protocol violations of inclusion/exclusion criteria, and had no other violations affecting efficacy assessments.|||percentage of participants|||Number
1418996|NCT01107418|Primary|Terminal Elimination Half-Life (t1/2) of Vemurafenib on Day 15|Time measured for vemurafenib plasma concentrations to decrease by one-half (t1/2) was calculated as 0.693 divided by apparent first-order terminal elimination rate constant (0.693/kel).|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||hours||Standard Deviation|Mean
1418997|NCT01107418|Primary|Apparent Clearance (CL/F) of Vemurafenib on Day 15|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||liters/hour (L/h)||Standard Deviation|Mean
1418998|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||hours||Full Range|Median
1418999|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg/mL||Standard Deviation|Mean
1419000|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC[0-168h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24, 28, 72, 76, 168 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
1419001|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
1419002|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 15||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 15|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
1419003|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||hours||Full Range|Median
1419004|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg/mL||Standard Deviation|Mean
1419005|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 9||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 9|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
1419006|NCT01107418|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.|||hours||Full Range|Median
1419007|NCT01107418|Primary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|PK population.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
1419008|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8, 24 hours post-dose on Day 1|PK population. Here, number of participants analyzed signifies participants evaluable for this outcome.|||mcg*h/mL||Standard Deviation|Mean
1419009|NCT01107418|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours (AUC[0-8h]) of Vemurafenib on Day 1||Pre-dose, 1, 2, 4, 5, 8 hours post-dose on Day 1|Pharmacokinetic (PK) population included all participants who provided essential PK data up to and including the pre-dose PK sample taken on Cycle 1, Day 22, without major protocol violation.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
1419010|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 4 (initial challenge)|Visit 4 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
1419011|NCT01107405|Secondary|Ocular Itching|Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.|Visit 4 (initial challenge)|Visit 4 Ocular Itching Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
1419012|NCT01107405|Secondary|Conjunctival Redness|Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.|Visit 3 (initial challenge)|Visit 3 Conjunctival Hyperemia Scores – ITT Population with LOCF included data from all randomized subjects who received treatment and had at least 1 post-CAC assessment.|||units on a scale||Standard Deviation|Mean
1419016|NCT01107392|Secondary|Duration of Effect|Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was < 4-points.|24 Weeks|Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis.|||Weeks||95% Confidence Interval|Median
1419017|NCT01107392|Secondary|Change From Baseline in Peak Urine Flow Rate|Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.|Baseline, Weeks 6, 12 and 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure.|||mL/sec||Standard Deviation|Mean
1419018|NCT01107392|Secondary|Change From Baseline in the Total International Prostate Symptom Score (IPSS)|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 6, Week 24|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.|||Score on a scale||Standard Deviation|Mean
1419019|NCT01107392|Primary|Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12|IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.|||Score on a scale||Standard Deviation|Mean
1419020|NCT01107379|Primary|Mean Intra-patient Change in Lund-Mackay CT Scan Score|"Change in Lund-Mackay CT score for paired baseline and 24 week data.~The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.|||Scores on a scale||Standard Deviation|Mean
1419021|NCT01107379|Secondary|Mean Number of Days to Return to Normal Activities|Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living|2 weeks|Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.|||days||Standard Deviation|Mean
1419022|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.|Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.|Day 0 (Day of Procedure)||||number of sinuses|Participants||Number
1419023|NCT01107379|Secondary|Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary|Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary|Day 0 (Day of Procedure)||||number of sinuses|Participants||Number
1419024|NCT01107379|Secondary|Procedure Tolerability|Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.|Day 0 (Day of Procedure)|Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.|||number of participants|||Number
1419025|NCT01107379|Primary|Mean Intra-patient Change in SNOT-20 Score|"Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.~The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5."|Baseline and 24 weeks|The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.|||Scores on a scale||Standard Deviation|Mean
1419026|NCT01107353|Primary|Bioequivalence Determined by Statistical Comparison Cmax|Blood samples were collected pre-dose and at intervals over 120 hours after each dose|33 Days||||ng/mL||Standard Deviation|Mean
1419027|NCT01107197|Secondary|the Percentage of Change in Area|the reduction in ulcer area (%) observed at 4 weeks|4 weeks of nutritional support (baseline and week 4)||||percent change||Inter-Quartile Range|Median
1419028|NCT01107197|Secondary|Dressings|The number of dressings used throughout the intervention period|8 weeks of nutritional support (baseline and week 8)||||dressings||Standard Deviation|Mean
1419029|NCT01107197|Secondary|Cost-effectiveness|Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active – control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy).|8 weeks of nutritional support (baseline and week 8)||||Euros||Standard Deviation|Mean
1419035|NCT01106976|Primary|AChE PET Neuroimaging|AChE PMP PET hydrolysis rate outcome measure. AChE [11C]PMP hydrolysis rates (k3) were estimated using the striatal volume of interest (defined by manual tracing on the MRI scan of the putamen and caudate nucleus) as the tissue reference for the integral of the precursor delivery. This measure is a proxy measure for the count of cholinergic nerve terminals in the basal forebrain innervation the cortical mantle.|4 yr|Parkinson disease.|||1/min||Standard Deviation|Mean
1419036|NCT01106950|Secondary|Percent of Patients With Natural Killer Cell Expansion Versus KIR Genotype Versus Treg Depletion|Association between in vivo natural killer (NK) cell expansion and complete response without platelet recovery (CRp) with donor killer immunoglobulin-like (KIR) genotype and Treg depletion. In vivo donor NK cell expansion was correlated with regulatory T-cell (Treg) depletion as detected on flow cytometry.|Day 14||||Percentage of patients|||Number
1419037|NCT01106950|Secondary|Number of Patients With Treatment-Related Death|Number of patients who died within the first 100 days of treatment due to toxicity.|Day 100||||Percentage of patients|||Number
1419038|NCT01106950|Secondary|Percent of Patients With Incidence of Relapse|Number of patients who have had a relapse(the return of disease after its apparent recovery/cessation) after obtaining a complete remission of their disease.|Month 6||||Percentage of patients|||Number
1419039|NCT01106950|Secondary|Percent of Patients With Disease Free Survival|Number of patients alive and disease free at 6 months. The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.|Month 6||||Percentage of patients|||Number
1419040|NCT01106950|Secondary|Percent of Patients With Complete Remission of Disease|Disease response was defined as complete remission (disease response) by morphologic criteria including <5% blasts in a moderately cellular or cellular marrow. Complete remission was also correlated with NK cell expansion in vivo, IL-15 levels and donor/recipient KIR B genotyping, and Treg depletion.|At least 4 weeks after last dose (28 days)||||Percentage of patients|||Number
1419041|NCT01106950|Primary|Percent of Patients With Successful Expansion of Natural Killer Cells After Infusion|The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/ul in the patient's peripheral blood 14 days after infusion.|Day 14||||Percentage of patients|||Number
1419042|NCT01106911|Primary|Number of Participants Without Cancer Who Were Recalled|Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.|upon recruitment/enrollment phase completion|Includes only participants who were not diagnosed as having a breast malignancy.|||participants|||Number
1419043|NCT01106898|Primary|Recurrence-free Survival|Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.|Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years||||percentage of subjects||95% Confidence Interval|Number
1419044|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 3.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population|||proportion|||Number
1419045|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 3.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 3.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 3.5 cm and <= -3.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 3.5 cm, and an improved performance is when the difference of SDLP < -3.5 cm.|3-9 hours post dose|Intent to treat population|||participants|||Number
1419046|NCT01106859|Secondary|Probability of Differences From Placebo Exceeding The 2.0 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population|||proportion|||Number
1419047|NCT01106859|Secondary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.0 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car's roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.0 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.0 cm and <= -2.0 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.0 cm, and an improved performance is when the difference of SDLP < -2.0 cm.|3-9 hours post dose|Intent to treat population|||participants|||Number
1419064|NCT01106833|Secondary|Percentage of Participants With Discontinuation of Systemic Immunosuppressive Therapy at Two Years|The percentage of participants discontinuing all systemic immunosuppressive therapy by two years post-randomization is described. Death is considered a competing risk for this endpoint.|2 years post-randomization||||percentage of participants||95% Confidence Interval|Number
1426115|NCT01043640|Secondary|Number of Patients Who Died Peri-Transplant|Peri-transplant is defined as within 100 days of transplant.|By Day 100 Post Transplant||||Participants|||Count of Participants
1419048|NCT01106859|Primary|Probability of Differences From Placebo Exceeding The 2.5 cm Threshold in Standard Deviation of Lateral Position (SDLP) Following Administration of Active Therapy|"This table represents the probability of driving performance changes summarized in the previous table. It answers the question: What is the chance that # participants out of the total number of participants had better (or worse) driving performance? Probability values of <.001 are listed in the data table as 0.000.~A symmetry analysis was conducted for the probability of difference in mean SDLP (treatment) - mean SDLP (placebo) exceeding thresholds. Statistically significant asymmetries indicate a decrement in driving performance."|3-9 hours post dose|Intent to treat population|||proportion|||Number
1419049|NCT01106859|Primary|Number of Participants Whose Standard Deviation of Lateral Position (SDLP) Following Active Treatment As Compared to Placebo In Relation To The 2.5 cm SDLP Threshold|SDLP was measured by an infrared camera mounted on the car’s roof during a highway driving test. Lateral position of the car relative to the left lane boundary was recorded. The data summarizes the number of participants whose driving performance was worse, neutral or improved as compared to placebo at the 2.5 cm threshold. A neutral driving performance shows a difference of SDLP >= 2.5 cm and <= -2.5 cm when compared to placebo. A worse performance is when the difference of SDLP > 2.5 cm, and an improved performance is when the difference of SDLP < -2.5 cm.|3-9 hours post dose|Intent to treat population|||participants|||Number
1419050|NCT01106859|Secondary|Summary of Participants With Treatment Emergent Adverse Experiences (TEAEs)|Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness (summarized as 'unrelated' and 'related') to study treatment. Also included are counts of participants with serious AEs, AEs leading to discontinuation of study treatment, and deaths.|Day 1 -6 weeks|Safety population (participants who were randomized and received at least one dose of study drug)|||participants|||Number
1419051|NCT01106859|Secondary|Mean Standard Deviation of Speed (SDS) in the Highway Drive Test|Mean standard deviation of speed (SDS) is a common measure of the driver's ability to maintain a constant driving speed. Variations in driving speed are recorded and analyzed.|3-9 hours post dose|Intent to treat population. In one Zopiclone case, the velocity of the car was not recorded due to technical problems, and therefore SDS could not be calculated in this drive.|||kilometers/hour||Standard Error|Least Squares Mean
1419052|NCT01106859|Secondary|Mean Standard Deviation of Lateral Position (SDLP) in the Highway Driving Test|Standard deviation of lateral position (SDLP) in a highway-driving lane is a surrogate measure for driving performance. It measures the driver's ability to stay in a constant position within the driving lane. Variations in the lateral position are recorded and analyzed.|3-9 hours post dose|Intent to treat population|||centimeters||Standard Error|Least Squares Mean
1419053|NCT01106846|Primary|Quality of Recovery Score Post Operative at 24 Hours|Quality of recovery 40 score at 24 hours after the surgical procedure. 40 being a poor recovery and 200 being a good recovery.|24 hours post operative||||units on scale||Standard Deviation|Mean
1419054|NCT01106833|Secondary|FACT-BMT Score|The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.|Up to 2 Years Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||score on a scale||Standard Error|Mean
1419055|NCT01106833|Secondary|SF-36 Mental Component Summary|The Medical Outcome Study SF-36 Mental Component Summary (MCS) is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Up to 2 Years Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||score on a scale||Standard Error|Mean
1419056|NCT01106833|Secondary|SF-36 Physical Component Summary|The Medical Outcome Study SF-36 Physical Component Summary (PCS) is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.|Up to 2 Years Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||score on a scale||Standard Error|Mean
1419057|NCT01106833|Secondary|NIH Consensus Criteria Chronic GVHD Severity|Chronic GVHD severity was determined at baseline and at 6 months, 1 year, and 2 years post-randomization per the 2005 NIH Consensus Criteria (Filipovich et al. 2005). Severity is categorized as none, mild, moderate, and severe.|Up to 2 Years Post-randomization|Outcomes are analyzed in participants that were alive and whose clinical assessments were completed.|||Participants|||Count of Participants
1419058|NCT01106833|Secondary|Provider-reported Chronic GVHD Severity|Each patient's care provider's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.|Up to 2 Years Post-randomization|Outcomes are analyzed in participants that were alive and whose providers completed assessments.|||Participants|||Count of Participants
1419059|NCT01106833|Secondary|Patient-reported Chronic GVHD Severity|Each patient's perception of the severity of the chronic GVHD was collected at baseline and at 6 months, 1 year, and 2 years post-randomization. Severity is categorized as none, mild, moderate, and severe.|Up to 2 Years Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||Participants|||Count of Participants
1419060|NCT01106833|Secondary|Change in Serum Creatinine Level From Baseline|Change in creatinine level from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.|Up to 1 Year Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/dL||Full Range|Median
1419061|NCT01106833|Secondary|Serum Creatinine Level|Creatinine level is described by treatment arm at baseline, 6 months, and 1 year post-randomization.|Up to 1 Year Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/dL||Full Range|Median
1419062|NCT01106833|Secondary|Change in Prednisone Dose From Baseline|Change in the daily dose of prednisone from baseline, the time of randomization, is described by treatment arm at 6 months and 1 year post-randomization.|Up to 1 Year Post-randomization|Outcomes are analyzed in participants that were alive and completed assessments.|||mg/kg/day||Full Range|Median
1419067|NCT01106833|Secondary|Percentage of Participants With Failure-free Survival|Failure-free Survival is defined as survival without malignancy progression or initiation of secondary therapy for chronic GVHD. Progression, initiation of secondary therapy for chronic GVHD, and death are considered failures for this endpoint.|Up to 2 years post-randomization||||percentage of participants||95% Confidence Interval|Number
1419068|NCT01106833|Secondary|Percentage of Participants With Progression-free Survival|Progression-free Survival is defined as survival without malignancy relapse. Relapse and death are considered failures for this endpoint.|Up to 2 years post-randomization||||percentage of participants||95% Confidence Interval|Number
1419069|NCT01106833|Secondary|Percentage of Participants With Overall Survival|Overall survival is defined as survival of death from any cause.|Up to 2 Years post-randomization||||percentage of participants||95% Confidence Interval|Number
1419070|NCT01106833|Primary|Proportion of Participants With Treatment Success|Treatment success was evaluated at 6 months in Phase II and is defined as a complete or partial response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death. In Phase III, treatment success was evaluated at 24 months and is defined as a complete response without secondary systemic immunosuppressive therapy and no recurrent malignancy or death.|24 months post-randomization|Twelve participants withdrew study consent between 6 and 24 months post-randomization, so are excluded from the analysis of treatment success at 24 months.|||Participants|||Count of Participants
1419071|NCT01106690|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419072|NCT01106690|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419073|NCT01106690|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
1419074|NCT01106690|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419075|NCT01106690|Secondary|Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26|HOMA2-%B is a measure of beta cell function (the cells in the pancreas that produce and store insulin). The table below shows the least-squares (LS) mean change in HOMA2-%B from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||HOMA2-%B||Standard Error|Least Squares Mean
1419076|NCT01106690|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1419077|NCT01106690|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1419115|NCT01106586|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis.|||cells/µL||Standard Deviation|Mean
1419078|NCT01106690|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1419079|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419080|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419081|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
1419082|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419083|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1419084|NCT01106677|Secondary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each active treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus sitagliptin) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1419085|NCT01106677|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419086|NCT01106677|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419116|NCT01106586|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT analysis set|||percentage of participants|||Number
1419121|NCT01106534|Secondary|Major Bleeding for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419087|NCT01106677|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
1419088|NCT01106677|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419089|NCT01106677|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1419090|NCT01106677|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1419091|NCT01106677|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences between each canagliflozin or sitagliptin group and placebo.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1419092|NCT01106677|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin or sitagliptin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1419093|NCT01106651|Secondary|Percent Change in Total Hip Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in total hip BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419094|NCT01106651|Secondary|Percent Change in Femoral Neck Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in femoral neck BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419095|NCT01106651|Secondary|Percent Change in Distal Forearm Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in distal forearm BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419120|NCT01106586|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|ITT analysis set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1419096|NCT01106651|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change from Baseline to Week 26 in lumbar spine BMD for each treatment group as assessed by dual-energy X-ray absorptiometry (DXA). The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419097|NCT01106651|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 or each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419098|NCT01106651|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419099|NCT01106651|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
1419100|NCT01106651|Secondary|Change in Tissue Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Tissue percent total fat = body fat as a percentage of body fat + lean body mass. The table below shows the least-squares (LS) mean change in tissue percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1419101|NCT01106651|Secondary|Change in Region Percent Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|Region percent total fat = body fat as a percentage of (body fat + lean body mass + bone mass content). The table below shows the least-squares (LS) mean change in region percent total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific dual-energy X-ray absorptiometry (DXA) analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1419102|NCT01106651|Secondary|Change in Total Fat From Baseline to Week 26 in a Subset of Patients Undergoing Specific Dual-energy X-ray Absorptiometry (DXA) Analysis for Body Composition|The table below shows the least-squares (LS) mean change in total fat from Baseline to Week 26 for each treatment group in patients randomized to the subset of patients undergoing specific DXA analysis for body composition. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||kg||Standard Error|Least Squares Mean
1419103|NCT01106651|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419117|NCT01106586|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 modified intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.|||percentage of participants|||Number
1419104|NCT01106651|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1419105|NCT01106651|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1419106|NCT01106651|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1419107|NCT01106625|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419108|NCT01106625|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419109|NCT01106625|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mmHg||Standard Error|Least Squares Mean
1419110|NCT01106625|Secondary|Percent Change in Body Weight From Baseline to Week 26|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1419111|NCT01106625|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1419112|NCT01106625|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1419113|NCT01106625|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1435853|NCT00966446|Primary|Recurrent Infection|Confirmed new MRSA infections|Within 6 months|These study participants who self-reported re-infections of MRSA|||participants|||Number
1419122|NCT01106534|Secondary|ST for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419123|NCT01106534|Secondary|MACE for Treatment Population||12 through 30 months and 12 through 33 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419124|NCT01106534|Secondary|Major Bleeding for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419125|NCT01106534|Secondary|ST for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419126|NCT01106534|Secondary|MACE for ITT Population||12 through 30 months|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419127|NCT01106534|Primary|Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419128|NCT01106534|Primary|Incidence of ARC Definite or Probable ST||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419129|NCT01106534|Primary|Incidence of Composite of All Death, MI and Stroke (Defined as MACE)||12-33 months post-stent|Participants enrolled in the study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.||||||
1419130|NCT01106456|Primary|7-Day Point Prevalence Abstinence From Smoking for 6 Months|The primary outcome of the study was salivary cotinine-verified 7-day point prevalence smoking abstinence at 6 months (Have you smoked at least part of a cigarette in the past 7 days?) using responders-only analyses.|6 months|"The difference in the overall number of participants analyzed, from the number analyzed, in the ANBL arm, is due to missing data."|||Participants|||Count of Participants
1419131|NCT01106430|Secondary|Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1|UKU-SERS-Clin is composed of 48 items each of which asks about a single side effect. Each side effect is rated based on a 4-point scale ranging from 0 (no or doubtful presence) to 3 (the least favorable rating). The rating is independent of whether the symptom is regarded as related to the investigational product.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||participants|||Number
1419132|NCT01106430|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||participants|||Number
1419133|NCT01106430|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 9 weeks|Safety Population defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
1419134|NCT01106430|Secondary|Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
1419135|NCT01106430|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1419136|NCT01106430|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and 9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1419137|NCT01106430|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product.|||percentage of participants|||Number
1419138|NCT01106430|Primary|Time to First Response|Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|9 weeks|Full Analysis Set defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. One subject was randomized to receive Strattera, but actually received Lisdexamfetamine Dimesylate. For all efficacy analyses this subject is included in the Strattera arm per the intention to treat principle.|||Days||95% Confidence Interval|Median
1419139|NCT01106404|Secondary|NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant|The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning “No pain” and 10 meaning “Pain as bad as you can imagine,” accompanied by the instructions “Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours.” The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits.|Baseline, 10 weeks and 16 weeks post-implant|69 of the 76 subjects completed pain diary for both baseline and 10 weeks. 69 of the 76 subjects completed pain diary for both baseline and 16 weeks. Since 2 datasets had 2 different pairs of data due to different subjects who completed the pain diary, baseline NPRS in two analyses varied slightly.|||units on a scale||Standard Deviation|Mean
1419140|NCT01106404|Secondary|Manual Adjustments Presented as Button Presses|The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared.|Baseline, 10 weeks and 16 weeks post-implant|Subjects with manual adjustments data from patient programmer were included in the analysis.|||Button presses per day||Standard Deviation|Mean
1419141|NCT01106404|Secondary|Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming|The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded “much worse pain relief with AdaptiveStim” or “somewhat worse pain relief with AdaptiveStim”.|16 weeks post-implant|A total of 71 subjects with completed data were included in this analysis.|||percentage of participants|||Number
1419142|NCT01106404|Primary|Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm|After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.|16 weeks post-implant|"The ITT analysis included 74 subjects; 2 randomized subjects, who discontinued early due to infections, were excluded per protocol. The 3 other subjects who discontinued early were included in ITT analysis and imputed as failures for the primary objective.~No imputation method was used for 71 subjects included in the completed case analysis."|||percentage of participants|||Number
1419143|NCT01106391|Primary|Rate of Primary Safety Endpoint Within 1 Month Post-procedure.|Primary safety is defined by the absence of Types I, III or IV endoleaks and device and/or procedural related major adverse events within 1 month post-procedure. Major adverse events include death, MI, stroke and renal failure.|One month follow-up|The analysis population consists of subjects with complete core laboratory data at 1 month.|||participants|||Number
1419144|NCT01106391|Primary|Rate of Technical Success Through the One Month Follow up.|Technical success is defined as the successful deployment of the stent-graft to the desired location in the absence of Types I, III or IV endoleaks at the conclusion of the procedure and through the one month follow up.|From procedure to one month follow up|All enrolled subjects|||participants|||Number
1419145|NCT01106352|Other Pre-specified|Number of Subjects Who Responded to Interactive Voice Response System (IVRS) Pain|The subject completed the full BPI (short form) paper questionnaire, and clinical staff completed the analgesic log. The test consists of 10 questions addressing severity, location, chronicity, and amount of relief. In question 3, subjects with pain are asked to evaluate the severity of pain at worst in the past 24 hours in a 0 to 10 scale, with 0 indicating no pain, and 10 indicating the worst pain.|From start of study treatment until 12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||Participants|||Number
1419146|NCT01106352|Other Pre-specified|Overall Survival Rate|The overall survival (OS) time in days was calculated as number of days since the day of first dose of study medication until the date of death.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
1419147|NCT01106352|Other Pre-specified|Progression Free Survival (PFS) End Point|PFS defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (radiological or clinical, whichever was earlier) or death (if death occurred before progression was documented). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
1419148|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Clinical or Radiographic Progression|"Time to first radiologic or clinical progression is determined by one of the following:~For soft tissue lesions, the determination is based on Response Evaluation Criteria in Solid Tumors 1.1.~For bone disease, the determination is based on Prostate Cancer Working Cohort 2 (PCWG2) definitions, which require the appearance of at least 2 new lesions with a confirmatory bone scan at least 6 or more weeks later. For clinical progression, the investigators followed the recommendations of the PCWG25 and used their clinical judgment to determine clinical progression."|From start of study treatment to 12 months, at every 12 weeks|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
1419149|NCT01106352|Other Pre-specified|Exploratory Efficacy: Percent Change From Baseline in Circulating Tumor Cells at Day 85|CTCs were measured to follow the evolution of the level of CTCs after treatment.|Baseline, Day 85, expanded safety cohort|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||Percent Change||Standard Deviation|Mean
1419150|NCT01106352|Other Pre-specified|Exploratory Efficacy: Time to Prostate-specific Antigen (PSA) Progression|Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least 1 week apart.|12 months|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||days||95% Confidence Interval|Median
1419151|NCT01106352|Other Pre-specified|Exploratory Efficacy: Weighted Mean Area Under the Curve for Bone Turnover Biomarkers|Weighted mean area under the curve for the below bone turnover biomarkers were evaluated, ICTP = pyridinoline cross-linked carboxyterminal telopeptide P1NP = N-terminal peptide of procollagen type 1 uCTX-1 = urine C-telopeptide 1|From start of study treatment to 6 weeks after study treatment (maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Subjects included in the per protocol: All subjects in the ITT population who received at least 40% of the specified number of administrations of radium-223 dichloride (in the radium-223 dichloride cohort) or of docetaxel (in the docetaxel cohort), and who did not have any major protocol violations.|||mcg/L||Standard Deviation|Mean
1419152|NCT01106352|Primary|Number of Subjects With Signs of Long-Term Radiation Toxicity|Long-term radiation toxicity included incidence of potential late toxicity, such as new primary cancers and bone marrow changes (acute myelogenous leukemia, myelodysplastic syndrome, and aplastic anemia).|From start of study treatment upto 12 months|Only participants who received treatment were assessed|||Participants|||Number
1419153|NCT01106352|Primary|Number of Subjects With Physical Examination During the Treatment Period|Any physical examination finding that was classified by the investigator as a clinically significant change (compared with previous examination) was considered an AE, documented on the eCRF, and followed until the outcome was known. The below physical examination findings were recorded and reported. GDASC = General disorders and administration site conditions MND = Metabolism and nutrition disorders SSTD= Skin and subcutaneous tissue disorders MCTD = Musculoskeletal and connective tissue disorders IPPC = Injury, poisoning and procedural complications RTMD = Respiratory, thoracic and mediastinal disorders NBMU = Neoplasms benign, malignant and unspecified (include cysts and polyps) In the below table.|From start of study treatment to 6 weeks after study treatment (i.e., maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||Participants|||Number
1419154|NCT01106352|Primary|Changes From Baseline in Weight During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||kilogram(s)||Standard Deviation|Mean
1419155|NCT01106352|Primary|Changes From Baseline in Heart Rate During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||beats per min||Standard Deviation|Mean
1419156|NCT01106352|Primary|Changes From Baseline in Respiratory Rate During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||breaths/min||Standard Deviation|Mean
1419157|NCT01106352|Primary|Changes From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|From start of study treatment to 6 weeks after study treatment (that is, maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort)|Only participants who received treatment were assessed|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1419158|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Erythrocytes) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||tetra per liter (TI/L)||Standard Deviation|Mean
1419159|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Platelets, Leukocytes, Lymphocytes, Neutrophils, Monocytes, Eosinophils, Basophils) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||giga per liter (GI/L)||Standard Deviation|Mean
1438505|NCT00946023|Secondary|Engraftment|Percentage of patients who engrafted neutrophils and platelets.|Day 60||||percentage of participants||95% Confidence Interval|Number
1419160|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Calcium, Chloride, Magnesium, Potassium, Phosphate, Sodium, Urea) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||millimole(s)/liter||Standard Deviation|Mean
1419161|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Bilirubin, Creatinine) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||micromole(s)/litre||Standard Deviation|Mean
1419162|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Alkaline Phosphatase [AP], Alanine Aminotransferase [AAT], Lactate Dehydrogenase [LD]) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only participants who received treatment were assessed|||units per liter (U/L)||Standard Deviation|Mean
1419163|NCT01106352|Primary|Change From Baseline in Serum Biochemistry (Albumin, Protein, Hemoglobin) During the Treatment Period|In the below table, ‘n’ signifies those subjects who were evaluable for this measure at given time points for each group.|Baseline, Day 106 (dose escalation period), and Day 190 (expanded safety cohort)|Only randomized participants who have this outcome measure tested were assessed|||gram per liter (G/L)||Standard Deviation|Mean
1419164|NCT01106352|Primary|Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Treatment-Emergent Serious Adverse Events (TESAE) With a CTCAE Grade of 3 or 4|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in patient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study treatment to 6 weeks after study treatment (that is maximum 12 weeks in dose escalation; 30 weeks in the expanded safety cohort) and 8 weeks for serious AEs|Only participants who received treatment were assessed|||Participants|||Number
1419165|NCT01106352|Primary|Number of Subjects With Dose-Limiting Toxicities – Dose Escalation Part|DLT was defined as - Absolute neutrophil count grade greater than or equal to (>=) 4 (Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0: less than [<] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade >= 4 (CTCAE, v4.0: < 25× 109/L) lasting longer than 7 days. Diarrhea Grade >= 3 (CTAE, v4.0: increase of >= 7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care in activities of daily living) in spite of optimal use of antidiarrheal medication. Vomiting or constipation Grade >= 4 (CTCAE, v4.0: life-threatening consequences; urgent intervention indicated). Febrile neutropenia Grade >= 3 (CTCAE, v4.0).|From randomization until 6 weeks post-injection in all dose cohort of dose-escalation part||||Participants|||Number
1419166|NCT01106326|Secondary|Additional Asthma Morbidity Measures|We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments.|2 month, 4 month, final follow-up assessments|||||||
1419167|NCT01106326|Primary|Number of Symptom-free Days Over Two Weeks|We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.|2 and 4 month follow-up assessments|Analysis conducted per protocol.|||Days||Standard Deviation|Mean
1419168|NCT01106287|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Only treatment-emergent adverse events were examined for this outcome measure.|Up to 6 weeks after the first dose of study drug|All participants receiving any dose of MK-0941 of placebo.|||participants|||Number
1419169|NCT01106287|Primary|Number of Participants Who Experienced One or More Adverse Events During the Study||Up to 30 days after the last dose of study drug|All participants receiving any dose of MK-0941 or placebo|||participants|||Number
1419170|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Time to Maximum Observed Plasma Concentration (Tmax).|Pharmacokinetic profile of eribulin mesylate (tmax).|Days 1 and 8|Pharmacokinetic Population|||hours||Full Range|Median
1419171|NCT01106248|Secondary|To Further Explore the Safety and Tolerability of Eribulin Mesylate When Administered on Days 1 and 8 of a 21-day Cycle in Patients With Solid Tumors.||21 day cycle|||||||
1419172|NCT01106248|Secondary|To Assess Best Overall Response Using RECIST Criteria in Patients With Measurable Disease.||21 day cycle|||||||
1419173|NCT01106248|Secondary|Pharmacokinetic Profile of Eribulin Mesylate: Observed Maximal Plasma Concentration (Cmax)|Pharmacokinetic profile of eribulin mesylate (Cmax).|Days 1 and 8|Pharmacokinetic Population|||ng/mL||Standard Deviation|Mean
1419174|NCT01106248|Primary|Mean Time-matched, Baseline Corrected QTcF at Any Time Point Postdosing.|The primary endpoint is mean time-matched, baseline corrected QTcF at any time point postdosing. This was to determine the effect of eribulin on cardiac repolarization as measured by QT/QTc interval.|48 hours postdose after Day 1 and after Day 8|Per Protocol Population|||msec||Standard Deviation|Mean
1419175|NCT01106157|Secondary|Change in White Blood Count (WBC) From Baseline to 12 Months|Change in WBC over 12 months|Change from baseline to 12 months||||Change in percentage of WBC||Standard Deviation|Mean
1419176|NCT01106157|Secondary|Percentage of Neutrophils|Change in Neutrophil Count over 12 months|Change from baseline to 12 months||||Percentage of neutrophils||Standard Deviation|Mean
1419177|NCT01106157|Secondary|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) From Baseline to 12 Months|Change in Zinc Transporter 8 Autoantibodies (ZnT8A) over 12 months|Change from baseline to 12 months||||nmol/L||Standard Deviation|Mean
1419184|NCT01106157|Primary|Change in Metabolic Function Baseline to 12 Months.|Area Under Curve (AUC) C-peptide production. Subjects underwent a 2 hour mixed meal tolerance test (MMTT) using a 6ml/kg load of boost to stimulate insulin production. Samples were collected at baseline, 10 minutes, 20 minutes, 30 minutes, 60 minutes, 90 minutes, and 120 minutes. AUC was then calculated. Subjects repeated the MMTT at baseline, 3, 6, 9, and 12 months following ATG/GCSF or placebo. The primary outcome for the study was the change over 12 months in AUC C-peptide (1 year - baseline) for those who received ATG/GCSF versus the change in AUC C-peptide (1 year - baseline) for those who received placebo|Baseline and 12 months||||nmol/L/min||Standard Deviation|Mean
1419185|NCT01106092|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1419186|NCT01106092|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1419187|NCT01106092|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1419188|NCT01106092|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1419189|NCT01106092|Secondary|Number of Subjects With a Booster Response for Anti-BPT|Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1419190|NCT01106092|Secondary|Anti-BPT Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1419191|NCT01106092|Secondary|Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)|Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1419192|NCT01106092|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1419193|NCT01106092|Secondary|Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)|Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subject for whom immunogenicity data were available.|||Participants|||Count of Participants
1419194|NCT01106092|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1419195|NCT01106092|Secondary|Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)|Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|Prior to (At Month 0) and one month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1419196|NCT01106092|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1439461|NCT00939211|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average systolic blood pressure value|0, 30 min, 2 h, 4 h||||mmHg||Standard Deviation|Mean
1419197|NCT01106092|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)|Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).|Prior to (At Month 0) and one month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1419198|NCT01106092|Secondary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.|Prior to booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1419199|NCT01106092|Secondary|Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3|Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1419200|NCT01106092|Primary|Anti-polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|One month after booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1419201|NCT01106092|Primary|Anti-polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to booster vaccination (At Month 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1419202|NCT01106092|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.|One month after booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1419203|NCT01106040|Secondary|Reverse Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by Lymphoseek that were also detected by blue dye.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node detected by Lymphoseek (at ≥ 3σ count) in vivo, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
1419204|NCT01106040|Primary|Concordance of Blue Dye and Lymphoseek|The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.|Surgery after injections of Lymphoseek and blue dye|All enrolled patients who were injected with both Lymphoseek and blue dye, who underwent surgery and had at least one lymph node stained intraoperatively by blue dye, and for whom the tissue type (lymphatic/non-lymphatic) and pathology status (presence/absence of tumor cells) was confirmed.|||Proportion of Lymph Nodes|Participants|95% Confidence Interval|Number
1419205|NCT01106027|Primary|Number of Subjects With Acute Humoral Rejection (AHR) up to One Year Post Transplant.|Diagnosis of AHR will be based histological findings using Banff ’05 criteria.|1 year posttransplant|The one subject who completed the study did not have acute humoral rejection. The other subject had the transplant but lost the graft early, meeting one of the endpoints of the study.|||Participants|||Count of Participants
1419206|NCT01106014|Secondary|Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC)||Week 26|Full analysis set. Patients with WHO FC IV at baseline were excluded from this analysis as they could not shift to a worse category|||Percentage of patients|||Number
1419207|NCT01106014|Secondary|Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough|The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. If the patient was used to taking bronchodilators before a walk, he/she was given them 5 to 30 min before the test. Also if the patient was on chronic oxygen therapy, oxygen was given at their standard rate during the test. Absolute change from baseline to Week 26 in 6MWD was measured at trough, i.e., either on the next day after the last study drug administration or at least 12 hours after study drug administration if on the same day.|Week 26|Full analysis set|||Meters||Full Range|Median
1419208|NCT01106014|Primary|Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake|"Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points).~Morbidity event was defined as any of the following events confirmed by the Critical Event committee:~Hospitalization for worsening of pulmonary arterial hypertension (PAH),~Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy,~Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH,~Disease progression which was defined by a decrease in 6-minute walk distance from baseline (>=15%, confirmed by a 2nd test on a different day) combined with worsening of WHO FC for patients belonging to WHO FC II/III at baseline, or combined with the need for additional PAH-specific therapy for patients belonging to WHO FC III/IV at baseline.~Note: The number of patients at risk decreased over time but this cannot be captured below"|Up to 7 days after end of double-blind treatment (maximum: 4.3 years)|The primary endpoint was analyzed using the full analysis set, which includes all randomized patients evaluated according to the study drug to which they have been randomized (intention-to treat analysis set).|||Percentage of patients free of events||95% Confidence Interval|Number
1419631|NCT01101867|Secondary|Treatment Satisfaction|treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.|day 3|all participants who completed the survey|||points on a scale||Standard Deviation|Mean
1419209|NCT01105975|Secondary|Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score|EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline up to Week 18|Participants who had both baseline and at least one post-baseline EQ-5D measurements, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1419210|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 bicarbonate measurements.|||milliequivalents/Liter||Standard Error|Least Squares Mean
1419211|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Sodium|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 sodium measurements.|||milliequivalents/Liter||Standard Error|Least Squares Mean
1419212|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Potassium|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 potassium measurements.|||milliequivalents/Liter||Standard Error|Least Squares Mean
1419213|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 renin activity measurements.|||nanograms/milliliter/hour (ng/mL/h)||Standard Error|Least Squares Mean
1419214|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 aldosterone measurements.|||nanogram/deciliter (ng/dL)||Standard Error|Least Squares Mean
1419215|NCT01105975|Secondary|Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 BP measurements.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1419216|NCT01105975|Secondary|The Number of Episodes of Rashes at Any Time From Baseline Through Week 12|All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.|Baseline through Week 12|Participants who took study drug.|||events|||Number
1419217|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 CETP mass measurements.|||percent change of micrograms/mL (mcg/mL)||Standard Error|Least Squares Mean
1419218|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 CETP activity measurements.|||percent change of picomoles/mL/minute||Standard Error|Least Squares Mean
1419219|NCT01105975|Secondary|Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State||Baseline up to 12 weeks|Participants who were administered LY2484595 and had pharmacokinetics (PK) samples.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1419220|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 LDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
1419221|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 HDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
1419222|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 LDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
1419223|NCT01105975|Secondary|Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 HDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
1419224|NCT01105975|Primary|Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 LDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
1419225|NCT01105975|Primary|Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy|Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.|Baseline, Week 12|Participants who had both baseline and Week 12 HDL-C measurements.|||percent change of mg/dL||Standard Error|Least Squares Mean
1419226|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]|Subjective NRS response for each participant for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
1419227|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]|Subjective NRS response for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on tibio-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose post-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
1419228|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]|Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
1419229|NCT01105936|Secondary|Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]|Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on tibio-femoral joint. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose pre-scan after stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
1419230|NCT01105936|Secondary|Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]|Subjective NRS response for each participant was calculated as difference of pre-treatment NRS pain assessment before stimulus and post-treatment NRS pain assessment before stimulus. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to “No Pain” and 10 corresponding to “Extreme Pain or Pain as bad as you can imagine”.|Baseline and post-dose before stimulus|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Score on a Scale||Standard Deviation|Mean
1419231|NCT01105936|Secondary|BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution|Baseline to 2-5 hours post last dose administration|ITT population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Z-score||Standard Deviation|Mean
1419232|NCT01105936|Primary|Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]|BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.|Baseline to 2-5 hours post last dose administration|Intention-to-treat (ITT) population: all participants per period who received at least one treatment and had at least one post-baseline efficacy assessment. Missing data was not imputed.|||Z-score||Standard Deviation|Mean
1419233|NCT01105767|Primary|Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI||At the end of the 20 month study||||participants|||Number
1419234|NCT01105767|Primary|Incidence of Skin and Soft Tissue Infection (SSTI)||At the end of the 20 month study||||participants|||Number
1419235|NCT01105754|Secondary|Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.|The number of children who received guideline-based asthma care (eg: inhaled steroid prescription, counseling for triggers, counseling for adherence) at the intervention visit based on parent interview at the 2-week follow-up and medical record review.|2 week follow-up, and medical record review||||participants|||Number
1419239|NCT01105702|Primary|Median Progression-Free Survival (PFS)|PFS defined as time from date of diagnosis to most recent follow up, disease progression, or death. Disease progress defined as either clinical deterioration or radiographic progressive disease on magnetic resonance imaging (MRI) per updated response assessment in neuro-oncology criteria (Wen, et al).|Up to 50 months|Intent-to-treat population|||months||95% Confidence Interval|Median
1419240|NCT01105650|Secondary|Overall Survival|Number of participants alive at 1 year.|1 Year||||participants|||Number
1419241|NCT01105650|Secondary|Number of Participants With Progressive Disease at One Year||1 Year||||Participants|||Count of Participants
1419242|NCT01105650|Secondary|Time to Disease Progression|Time from study entry until progressive disease or data collection cutoff.|1 Year|"Number of participants with progressive disease at one year:~Arm 1: 2 out of 3; Arm 2: 1 out of 3; Arm 3: 5 out of 7"|||days||Full Range|Median
1419243|NCT01105650|Primary|Response Rate|Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.|Month 3||||participants|||Number
1419244|NCT01105533|Other Pre-specified|Effect of Food on Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 29 (fasted state), Day 30 (fed state) for once daily groups, pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 29 Day 29 (fasted state), Day 30 (fed state) for twice daily groups|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, food effect on AUC (0-24) was not assessed.||||||
1419245|NCT01105533|Secondary|Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25|Biomarkers included soluble plasma proteins associated with angiogenesis (vascular endothelial growth factor [VEGF], soluble vascular endothelial growth factor-2 receptor [sVEGFR2], soluble vascular endothelial growth factor-3 receptor [sVEGFR3], soluble beta type platelet-derived growth factor [sPDGFR beta]) and tumor proliferation (soluble stem-cell factor receptor [sKIT])|Baseline, Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25|Results are not reported as the data were not statistically summarized but available in individual participant listing.||||||
1419246|NCT01105533|Secondary|Number of Participants With Objective Response of Complete Response or Partial Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target and non-target lesions and no appearance of new lesions. Confirmed PR defined as at least 30 percent decrease in sum of the longest dimensions (LD) of the target lesions, taking as a reference the baseline sum LD, without progression of non-target lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Baseline, every 8 weeks up to Cycle 25 (Week 100)|Full Analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1419247|NCT01105533|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, PK analysis was not performed and hence, CL was not calculated.||||||
1419248|NCT01105533|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Vss was not calculated.||||||
1419249|NCT01105533|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0 - ∞) was not calculated.||||||
1419250|NCT01105533|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, AUC (0-24) was not calculated.||||||
1419251|NCT01105533|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hrs post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, t1/2 was not calculated.||||||
1419252|NCT01105533|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose,0.5,1,2,4,6,8,10,16,20,24 hours(hrs) post-dose on Day 1(0.67 mg group);pre-dose,0.5,1,2,4,6,8,18,20,24 hrs post-dose on Day 1,15,29(once daily groups);pre-dose,0.5,1,2,4,6,8 hrs post-dose on Day 1,15,29 (twice daily groups);pre-dose on Day 43, 57|Formal quality-assured, quality-controlled, pharmacokinetic (PK) analysis was not performed and hence, Cmax was not calculated.||||||
1419253|NCT01105533|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings. The twice daily dosing was preferred over once daily dosing for RP2D, as per investigator's discretion, due to more consistent changes in pharmacodynamic markers and greater clinical benefit observed in twice daily dosing.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg twice daily|||Number
1419254|NCT01105533|Primary|Maximum Administered Dose (MAD)|MAD: dose level at which 2 or more out of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg once daily|||Number
1419255|NCT01105533|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which no more than 1 of 6 participants experienced DLT during Cycle 1. DLTs: blood pressure of 180/110 mmHg or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or >160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia >=7 days or >= Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree C or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg once daily|||Number
1419256|NCT01105533|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs included events occurring in Cycle 1: blood pressure of 180/110 millimeters of mercury (mmHg) or higher for 3 readings over 3 hours regardless of use of anti-hypertensive drugs or greater than (>) 160/100 mmHg for 3 readings over 3 days on maximum anti-hypertensive drugs; afebrile Grade 4 neutropenia for greater than or equal to (>=) 7 days or >=Grade 3 neutropenia associated with fever (1 reading of oral temperature >38.5 degree Celsius [degree C] or 3 readings of oral temperature >38.0 degree C in 24-hour period); Grade 4 thrombocytopenia; hemoptysis of >1/2 teaspoon of bright red blood per day; proteinuria of >=2 grams/24 hours; inability to resume PF-00337210 dosing at current dose level within 14 days of stopping due to treatment-related toxicity; >=Grade 3 nonhematological toxicities (except alopecia and blood pressure/hypertension); Grade 3 nonhematological toxicities that could be controlled to Grade 2 or less with appropriate treatment were not considered dose limiting.|Baseline up to Day 28|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1419257|NCT01105377|Secondary|Time to Progression|Time to disease progression (TTP) is defined as the time from the start of treatment to the earliest of the date documenting disease progression or most recent assessment for patients having no progression. The distribution of TTP is estimated using the method of Kaplan-Meier.|From the start of treatment to the earliest of the date documenting disease progression, assessed up to 3 years|Analysis for this endpoint was “per protocol” and two participants were excluded. One participant in Cohort I was ineligible and one participant in Cohort II refused to start their 1st cycle of study treatment (ie, cancelled). Therefore, 23 participants in Cohort I and 22 participants in Cohort II were analyzed for this secondary endpoint.|||months||95% Confidence Interval|Median
1419258|NCT01105377|Primary|Confirmed Tumor Response|Each evaluable patient is classified as having a confirmed tumor response if they have either a complete response (CR) or partial response (PR) lasts at least 4 weeks. Tumor response is measured by using RECIST v1.1 (Response Evaluation Criteria in Solid Tumors). A CR is defined as a disappearance of all target lesions, and each target lymph node must have reduction in short axis to <1.0 cm. A PR is defined as a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation, compared to pre-treatment measurements. The confirmed response rate is calculated as the number of confirmed CR+PR, divided by the total number of evaluable patients, with 95% confidence intervals estimated using the approach of Duffy and Santner.|At 6 month evaluation|Analysis was performed “per protocol” using only Cohort II participants, except those deemed ineligible, cancelled, or in major treatment violation during cycle 1. One of the 23 Cohort II participants was excluded in the analysis due to cancelling before initiating treatment.|||percentage of participants||95% Confidence Interval|Number
1419259|NCT01105312|Secondary|Confirmed Response Rate (Phase I)|A confirmed response is defined to be a CR or PR (as determined by RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The number of confirmed responses will be reported here.|from baseline up to 5 years|All 12 eligible phase I patients were treated and analyzed.|||Participants|||Count of Participants
1419260|NCT01105312|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) is defined as the time from the date of registration to the date at which the patient is removed from treatment due to progression, unacceptable adverse events, or refusal. The distribution of TTF will be estimated using the method of Kaplan-Meier|from baseline up to 5 years post-registration|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
1419403|NCT01104415|Primary|Number of Patients With Any Drug-related Treatment-emergent Adverse Event|An AE is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship.|124 weeks||||Participants|||Count of Participants
1419261|NCT01105312|Secondary|Clinical Benefit Rate|Clinical benefit rate will be estimated by the total number of patients with an objective status of CR, PR, or SD for duration of at least 6 months divided by the total number of evaluable patients. All evaluable patients will be used for this analysis. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated.|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.|||percentage of participants||95% Confidence Interval|Number
1419262|NCT01105312|Secondary|Duration of Response (Phase II)|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient’s objective status is first noted to be a CR or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|from baseline up to 5 years post-registration|13 of the 16 phase II patients were treated and analyzed|||months||95% Confidence Interval|Median
1419263|NCT01105312|Secondary|Progression-free Survival (Phase II)|Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. PFS at 6 months will be estimated. The distribution of PFS will be estimated using the method of Kaplan-Meier.|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
1419264|NCT01105312|Secondary|Time-to-disease Progression (Phase II)|"Time-to-disease progression (TTP) is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of TTP will be estimated using the method of Kaplan-Meier. Progression is defined as at least one of the following:~At least one new malignant lesion or a lymph node whose short axis has increased to >1.5 cm~At least a 20% increase in the sum of diameters of target lesions taking as reference the MSD. In addition, the sum must also demonstrate an absolute increase of at least 0.5 cm"|from baseline up to 6 months|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
1419265|NCT01105312|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|from baseline up to 5 years post-registration|13 of the 16 phase II patients were eligible, treated, and analyzed.|||months||95% Confidence Interval|Median
1419266|NCT01105312|Primary|Response Rate (Phase II)|"A confirmed response is defined to be a CR or PR (as determined by RECIST (version 1.1 criteria) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated using all cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.~A CR is defined as:~All of the following must be true:~Disappearance of all non-nodal target lesions~Each target lymph node must have reduction in short axis to <1.0 cm~A PR is defined as:~At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the BSD (Section 11.41)"|from baseline up to 5 years post-registration|13 of the 16 patients enrolled were eligible, treated, and analyzed for this endpoint.|||percentage of participants||95% Confidence Interval|Number
1419267|NCT01105312|Primary|Maximum-tolerated Dose (Phase I)|MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 > new patients). If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT are seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. The number of DLT's will be reported here.|Up to 2.5 months|All 12 phase I patients were eligible and analyzed for MTD.|||Participants|||Count of Participants
1419268|NCT01105247|Secondary|Percentage of Participants Achieving Response|Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).||||Percentage of Participants||95% Confidence Interval|Number
1419269|NCT01105247|Secondary|Progression Free Survival Rate at 24 Months|Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.|The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).||||Percentage of Participants||95% Confidence Interval|Number
1419270|NCT01105247|Secondary|Food Effect Cohort Assessments|Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose.|Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.|Note: 16 subjects were participated in food effect cohort. However, the PK parameters for 1 subject under Fasted treatment period cannot be reliably estimated. The data for this subject were excluded from Fed/Fasted comparison.|||||90% Confidence Interval|Number
1419271|NCT01105247|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AEs.|From first dose to within 30 days of last dose of PCI-32765||||Participants|||Number
1419272|NCT01105130|Secondary|Quality of Life|Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate (FACT_P) questionnaire. The FACT questionnaire is comprised of four subscales – social, emotional, functional, and physical. Each subscale is obtained by summing over 6-7 items, each of which is coded on a 0 to 4 scale. Negatively worded questions are reverse scored and higher scores for each subscale indicate better HRQOL. The social, functional, and physical subscales range from 0 to 28 while the emotional subscale ranges from 0 to 24. The overall score (FACT-G) is the sum over the four subscales and ranges from 0 to 108. Patients also completed 12 questions related to prostate cancer, and the prostate subscale score is the sum of those responses (with some items reverse scored). Scores range from 0 to 48, and as with the other FACT subscales higher scores indicate better HRQOL. FACT-P is the sum of FACT-G and the prostate subscale. This questionnaire was added half-way through the study.|8 weeks|All participants who completed the FACT_P at any time.|||units on a scale||Standard Error|Least Squares Mean
1439462|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose|15 min FEV1 value|15 min||||L||Standard Deviation|Mean
1419275|NCT01105130|Primary|Erectile Function|The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.|8 weeks|All participants providing data at any time.|||units on a scale||Standard Error|Least Squares Mean
1419276|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With PAH - Number of Deaths||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population|||participants|||Number
1419277|NCT01105117|Primary|Safety and Tolerability of ACT-385781A and Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) - Number of Patients With Adverse Events Leading Discontinuation of Study Treatment||Up to 39 days. Day 1 - until patients transition from study medication to commercially-obtained medication|Study population|||participants|||Number
1419278|NCT01105091|Primary|Body Weight - Baseline and Day 28|Body weight was measured both at baseline and day 28.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||kg||Full Range|Median
1419279|NCT01105091|Primary|Heart Rate - Baseline and Day 28|Heart rate was measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Heart Rate was assessed at Baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||Beats per minute||Full Range|Median
1419280|NCT01105091|Primary|Blood Pressure - Baseline and Day 28|Blood pressure (systolic and diastolic) were measured indirectly using an automatic oscillometric device, on the same arm for each measurement. The Blood Pressure was assessed at baseline and at Day 28 (End of Study Treatment visit).|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||mm Hg||Full Range|Median
1419281|NCT01105091|Primary|Percentage Central Venous Blood Oxygen Saturation (ScVO2) - Baseline and Day 28|Central venous blood oxygen saturation assessment was performed only in specific centers. Measurements for ScVO2 were performed during the inpatient hospitalization period on Day 1 (prior to drug initiation) and on Day 28 (EOT). Samples for ScVO2 were obtained by aspirating blood from the indwelling central venous catheter. After the sample had been drawn, the catheter was primed with study drug in order to refill the lumen to avoid interruption in treatment and sudden decompensation.|Baseline and 28 days|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||percentage oxygen saturation||Full Range|Median
1419282|NCT01105091|Primary|Patients With New York Heart Association (NYHA) Functional Class Change (Improved or Worsened) From Baseline to Day 28|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|From baseline to 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||participants|||Number
1419283|NCT01105091|Primary|Six-minute Walk Distance (6MWD) - Baseline and Day 28|The 6-minute walk test (6MWT) was to be performed prior to initiating study treatment either during the screening visit or on Day 1 prior to drug initiation, and Day 28 (End of treatment (EOT)). This assessment is a non-encouraged test that measures the distance walked for a duration of 6 minutes. The 6MWD was recorded in the Case Report Form (CRF).|Baseline and 28 days (+3 days)|Patients who had both baseline and Day 28 assessments were included in the analysis. The analysis was conducted without replacement of missing values.|||meters||Full Range|Median
1419284|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
1419285|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6-keto-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6-keto-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
1419286|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 4 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 4 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
1419287|NCT01105091|Primary|Dose Normalized Pharmacokinetics of 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha at 2 ng/kg/Min|The plasma concentration for the epoprostenol metabolite 6,15-diketo-13,14-dihydro-Prostacyclin F1alpha was measured at 2 ng/kg/min just prior to the next up-titration. Dose-normalized concentrations are used to summarize the results.|Day 1|A per-protocol analysis set that included all patients in the treated set who did not violate the protocol in a way that might affect the evaluation of the effect of the study drug(s) on the pharmacokinetic endpoints.|||(pg/ml)/(ng/kg/min)||Full Range|Median
1426620|NCT01038752|Secondary|Overall Survival of Participants|Insufficient Data|First treatment date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1419288|NCT01105065|Secondary|Frequency Doubling Perimetry|Frequency doubling perimetry was measured pre- and post treatment with brimonidine for 8 weeks.We used the full-threshold N-30 protocol to determine the visual field mean deviation, pattern standard deviation, and test duration in the eye that had hemodynamic testing. The results that are reported below are the mean deviation values recorded as part of the frequency doubling perimetry as these are the most significant.|8 weeks||||dB||Standard Deviation|Mean
1419289|NCT01105065|Primary|Presence of Retinal Blood Flow Autoregulation|We defined retinal vascular dysregulation based on the percentage change between the retinal blood flow measured while reclining for 30 minutes and the baseline seated measures. In a prior study, we found that healthy subjects exhibited a +6.5%±12% blood flow change induced by 30 minutes of reclining. Thus, we defined the normal range of blood flow autoregulation as within 2 standard deviations of the mean percentage change found in this group, or -17.5% to +30.5%.|8 weeks||||participants|||Number
1419290|NCT01104870|Secondary|Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 12|The N-terminal pro-BNP (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 12.|Baseline and Week 12|All subjects with Baseline and Week 12 NT-proBNP values recorded were included in the analysis.|||pg/mL||Standard Deviation|Mean
1419291|NCT01104870|Secondary|Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 12|The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. Only participants who experienced a change in WHO functional classification from Baseline to Week 12 are described by class change below; all other participants maintained their Baseline WHO functional classification at Week 12.|Change from Baseline at Week 12|All subjects with Baseline and Week 12 WHO functional classifications recorded were included in the analysis.|||participants|||Number
1419292|NCT01104870|Secondary|Change in PH Symptoms From Baseline to Week 12|Symptoms of PH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed and severity grade values (i.e., 0, 1, 2 or 3) for each symptom were assigned for subjects. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Median change in symptom severity from Baseline to Week 12 is described.|Change from Baseline at 12 Weeks|All subjects with Baseline and Week 12 values recorded for symptoms of PH were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
1419293|NCT01104870|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 12|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and Week 12|All subjects with Baseline and Week 12 Borg dyspnea scores recorded were included in the analysis.|||score||Inter-Quartile Range|Median
1419294|NCT01104870|Secondary|Change in 6-minute Walk Distance (6MWD) From Baseline to Week 12|The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 12, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). Subjects were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and Week 12|All subjects with Baseline and Week 12 6MWD values recorded were included in the analysis.|||meters||Standard Deviation|Mean
1419295|NCT01104870|Secondary|Change in Cardiac Index (CI) From Baseline to Week 12|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 CI values recorded were included in the analysis.|||L/min/m^2||Standard Deviation|Mean
1419296|NCT01104870|Secondary|Change in Mean Pulmonary Artery Pressure (PAPm) From Baseline to Week 12|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. The PAPm values and their respective changes from Baseline to Week 12 at peak exercise will be summarized by treatment group and measured by Swan-Ganz right heart catheterization.|Baseline and Week 12|All subjects with Baseline and Week 12 PAPm values recorded were included in the analysis.|||mmHg||Standard Deviation|Mean
1419297|NCT01104870|Primary|Change in Peak Total Pulmonary Resistance Index (TPRI) During Exercise From Baseline to Week 12|"The effects of 12-week treatment with different doses of UT-15C on peak TPRI during exercise will be evaluated by comparing the change from Baseline to Week 12 at peak wattage on a pairwise basis between treatment groups.~The primary measure of efficacy was the change from Baseline to Week 12 in peak TPRI during exercise assessed 3 to 6 hours after the subject’s morning dose of UT-15C to obtain measurements at peak concentrations of treprostinil. The equation used to determine the Total Pulmonary Resistance Index (TPRI) (mmHg/[L/min/m^2]) is Mean Pulmonary Artery Pressure (PAPm)/ Cardiac Index (CI)."|Baseline and Week 12|All subjects with Baseline and Week 12 TPRI values recorded were included in the analysis.|||mmHg/(L/min/m^2)||Standard Deviation|Mean
1419306|NCT01104701|Secondary|Mean Change in Fasting Glucose From Baseline to Week 20 - Evaluable Population|Fasting glucose was measured in milligrams per deciliter (mg/dL) at screening, Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.|||mg/dL||Standard Error|Mean
1419298|NCT01104701|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance (PCI): triacylglycerol lipase high values were > 3* upper limit of normal (ULN); creatinine high values in males >1.6 mg/dL, females >1.4 mg/dL; gamma glutamyl transferase (GGT) high value >3* ULN; bilirubin high value > 2 mg/dL; Urate high values > 10 (males), >8 (females) mg/dL; potassium low value < 3 milliequivalents per liter (mEq/L), high value >5.5 mEq/L; calcium low value < 8 mg/dL and high value > 11 mg/dL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance (values could be either low or high) are presented for Weeks 6 - Week 24 or early termination. Note: those tests with no values meeting the PCI criteria, ie, 0 values observed across all treatment arms, are not presented.|Day 1 to Study Termination (Week24) or early termination|All participants who were randomized and received at least one dose of study drug were analyzed in the intent to treat (ITT) population. n= all participants who received at least one dose of study drug and had available laboratory measurements.|||laboratory values|||Number
1419299|NCT01104701|Secondary|Number of Hematology Laboratory Values of Potential Clinical Importance Observed During Treatment Period - ITT Population|Potential clinical importance are the following: Hematocrit values for males less than (<) 36%, females < 30%; hemoglobin for males <12 grams per deciliter (g/dL), females < 10 g/dL; low platelet values <75,000/micro liter (µL), high values greater than (>) 500,000 µL. Laboratory samples were obtained at baseline (Day 1 or if unavailable, last measurement prior to first study drug dose), Weeks 6, 12, 20, and at study termination (Week 24) or early termination. Number of laboratory values of potential clinical importance presented for Weeks 6 - Week 24 or early termination.|Day 1 to study termination (24 weeks) or early termination|n= all participants who received at least one dose of study drug and had available laboratory measurements.|||laboratory values|||Number
1419300|NCT01104701|Secondary|Participants Negative or Positive for Anti-exenatide Antibodies - ITT Population|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1.|Day 1 to Study Termination (24 weeks) or early termination|n=all participants who received at least one dose of study drug and had available titer.|||participants|||Number
1419301|NCT01104701|Secondary|Number of Participants With Injection Site Reaction Treatment Emergent Adverse Events - ITT Population|"AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Injection site related adverse events were defined as the adverse events with 'injection site' phrase in preferred term excluding 'injection site nodule'. The following events were Injection Site Reaction AEs: erythema, hematoma, hemorrhage, site pain, site papule, site pruritus, site warmth.~Participants receiving study drug monthly received 5 injections with last injection at Week 16; Participants receiving study drug weekly received 20 injections with last injection at Week 19."|Day 1 through study termination (Week 24) or early termination.|All participants who received at least one dose of study drug were analyzed in the ITT population.|||participants|||Number
1419302|NCT01104701|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation - ITT Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. All participants who received at least one dose of study drug were included in the ITT analysis. Treatment-emergent (TE) adverse events were defined as those with onset at or after initiation of study medication on Day 1 through study termination or early termination.|Day 1 to Study Termination (24 Weeks) or early Termination|All participants who received at least one dose of study drug were included in the ITT analysis.|||participants|||Number
1419303|NCT01104701|Secondary|Mean Change From Baseline in Heart Rate at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Heart rate was measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in beats per minute (bpm). The measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the ITT population.|||bpm||Standard Deviation|Mean
1419304|NCT01104701|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure at Week 20 - Intent to Treat (ITT) Population|Baseline was Day 1, or last measurement prior to first dose of study drug. Vital signs were measured after the participant had rested for approximately 5 minutes and with the participant in a sitting position. Measurement was recorded in millimeters of mercury (mmHg). The blood pressure measurement was repeated after at least 30 seconds and the average of the two readings recorded. ITT population was defined as all participants who received at least one dose of the study drug.|Baseline (Day 1), Week 20|Participants who received at least one dose of study drug were analyzed in the Intent to Treat (ITT) population.|||mmHg||Standard Deviation|Mean
1419305|NCT01104701|Secondary|Time Weighted Average Concentration and Peak to Trough of Exenatide From Week 12 Through Week 16 - Pharmacokinetic Evaluable - Steady State Population|All participants received an initial blood draw prior to the first dose and a single blood sample was collected at all other subsequent visits, for plasma exenatide assessments and the characterization of pharmacokinetic (PK) parameters following multiple monthly doses over the study period. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Time weighted average concentration (Cave (2016-2688 h) and Peak to Trough were measured in picograms per milliliter (pg/mL).|Day 1 to Week 20|PK Evaluable- Steady-State: from trough to trough following Week 12 through Week 16, 3 or more values.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1419422|NCT01104207|Primary|Change in Tinnitus Functional Index (TFI) Score|The TFI is a 25-item questionnaire that assesses tinnitus severity. The possible range of scores for the TFI is 0 to 100, with higher scores indicating more severe tinnitus.|26 weeks post-treatment||||units on TFI scale; change from baseline||Standard Deviation|Mean
1419307|NCT01104701|Secondary|Mean Change in Body Weight From Baseline to Week 20 - Evaluable Population|Body weight was measured in kilograms (kg) at Baseline, and during treatment at Weeks 2, 4, 6, 8, 9-11, 12, 13, 14, 15, 16, 17-19, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. Evaluable population was defined as all participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis. n=number of participants with measurement value.|||kg||Standard Error|Mean
1419308|NCT01104701|Secondary|Percentage of Participants Achieving HbA1c Target Values at Week 20 - Evaluable Population|HbA1c was measured as a percent (%) of total hemoglobin. The Target values for HbA1c were <7% and ≤ 6.5% at Week 20. Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Week 20|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value for Week 20 were included in the analysis of the evaluable population. n=number of participants with measurement value.|||percentage of Participants|||Number
1419309|NCT01104701|Primary|Mean Change in HbA1c From Baseline to End of Treatment (Week 20) - Evaluable Population|HbA1c was measured as a percent of total hemoglobin at screening, Baseline, and during treatment on Weeks 4, 8, 12, 16, and 20. Baseline was Day 1, or last measurement prior to first dose of study drug. The Evaluable population was defined as participants who completed study procedures in compliance with the protocol and had adequate exposure to the study drug.|Baseline (Day 1) to 20 weeks|All participants who received at least one dose of study drug, complied with the protocol, had adequate study drug exposure, and had a measurement value on the specified week were included in the analysis of the evaluable population. n=number of participants with measurement value.|||Percent of Hemoglobin||Standard Error|Mean
1419310|NCT01104662|Secondary|Overall Therapeutic Outcome at Test of Cure (TOC)/Safety Visit|"Participants were assigned a Sponsor-assessed clinical outcome based on the following definitions at the TOC/Safety visit:~Failure: Assessed as a failure at any time by the Investigator or received non-study antimicrobial therapy for lack of efficacy or had the primary site of infection removed completely by surgery or underwent surgery to treat the infection >4 days after starting study medication.~Success: Were not assessed as a failure at any time and were assessed as a cure or improvement by the Investigator at the TOC visit.~Non-evaluable: Received potentially effective antimicrobial therapy during the study period for reasons other than lack of efficacy or received <4 days of study medication or were not assessed by the Investigator."|Baseline through TOC/Safety Visit|Participants who received at least 1 dose of study drug and had at least 1 Gram-positive baseline infecting pathogen for cSSSI participants or S. aureus bacteremia for bacteremia participants.|||participants|||Number
1419311|NCT01104662|Primary|Number of Participants With Treatment-emergent Creatine Phosphokinase (CPK) Elevations Through End of Therapy/Early Termination (EOT/ET)|The number of participants with CPK elevations of >500 units per liter (U/L) above baseline at any time from Day 1 through the EOT/ET visit are presented.|Baseline through EOT/ET|Participants who received at least 1 dose of study drug and had a baseline CPK value and at least 1 post-baseline CPK assessment between Day 1 post-dosing and EOT visit.|||participants|||Number
1419312|NCT01104636|Secondary|Level of Nicotine Dependence Measured by the Fagerstrom Test|Fagerstrom Test for Nicotine Dependence (FTND) was designed to provide measure of nicotine dependence related to cigarette smoking. It contains 4 yes-no and 2 multiple choice questions. Items are scored 0-3 for multiple choice items, items are summed to yield total score of 0-10 (0=minimum to 10=maximum nicotine dependence).|Baseline|The all participants’ population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.|||Scores on a scale||Standard Deviation|Median
1419313|NCT01104636|Primary|Percentage of Participants Who Abstained From Smoking at Week 12|The use of nicotine was recorded using Nicotine Use Inventory (NUI) to determine the participants who abstained from smoking for the previous 7 days. A responder for the 7-day point prevalence was defined as those with ‘no’ answers to the following two questions: Did the participant smoke any cigarettes (even a puff) in the last 7 days; and did participant use any other tobacco products (example pipe, cigars, snuff, chewing tobacco) in the last 7 days.|Week 12|The all participants' population included all enrolled participants who had received at least 1 dose (including partial doses) of study medication. Missing observations were not imputed and hence the participants analyzed are the ones without missing values.|||percentage of participants||95% Confidence Interval|Number
1419314|NCT01104584|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow–up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||Participants|||Number
1419315|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||beats/min||Standard Deviation|Mean
1419316|NCT01104584|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, 24 hours post injection|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||mmHg||Standard Deviation|Mean
1419317|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."||||||
1419318|NCT01104584|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level||Immediately before injection and after injection|"The Statistical Analysis Plan (SAP) amendment re-defined study objectives and replaced protocol-defined parameters such as categorical accuracy prior to database closure and breaking the blind. The SAP amendment is based upon review of results of an identical clinical study within the GEMMA program and also includes advice from the FDA."||||||
1419319|NCT01104584|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||Kappa|Participants||Number
1419320|NCT01104584|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
1419321|NCT01104584|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
1419322|NCT01104584|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Sensitivity Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||Kappa|Participants||Number
1419323|NCT01104584|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Clinical Investigator, Participant Level|The disease state “bilateral malignant disease” was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region , the assessment of bilateral malignant disease was categorized as “No”. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as “Yes”. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease were derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on 380 participants in FAS; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.|||difference in accuracy (%)||95% Confidence Interval|Mean
1419324|NCT01104584|Other Pre-specified|Sensitivity of Detection of Multicentric Malignant Disease Verified by SoT, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1419325|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
1419326|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
1419336|NCT01104584|Secondary|Percentage Difference of Participants Whose Additional Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The evaluation was based on the 84 participants in the FAS who had at least one additional cancer region according to SoT.|||difference in percentage of participants||95% Confidence Interval|Number
1419327|NCT01104584|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
1419328|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1419329|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. The difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1419330|NCT01104584|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions. Difference in sensitivity is calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1419331|NCT01104584|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N-FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 395 participants in FAS; evaluable for specificity were breasts with or without malignant disease verified by SoT with available assessments by the imaging modality.|||specificity (%)||95% Confidence Interval|Mean
1419332|NCT01104584|Other Pre-specified|Breast Level Specificity in Malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
1419333|NCT01104584|Other Pre-specified|Breast Level Specificity of in Non-malignant Breasts Using UMRM, XRM, CMRM+XRM and UMRM+XRM by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants; evaluable for specificity were breasts with no malignant disease verified by SoT for which an assessment of the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
1419334|NCT01104584|Other Pre-specified|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using XRM, CMRM+XRM and UMRM+XRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were performed for a total number of 390 participants who had regions with malignant disease verified by SoT with available assessment by the imaging modality.|||sensitivity (%)||95% Confidence Interval|Mean
1419335|NCT01104584|Secondary|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Reader, Participant Level|The investigator and the blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1 = not confident, 2 = somewhat confident, 3 = confident, and 4 = very confident). For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||difference of scores on a scale||95% Confidence Interval|Mean
1440154|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||6 weeks after first treatment|ITT|||percentage change from baseline||Standard Deviation|Mean
1419337|NCT01104584|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.|||difference in percentage of participants||95% Confidence Interval|Number
1419338|NCT01104584|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 390 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
1419339|NCT01104584|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 367 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SoT) for which a CMRM assessment was available.|||specificity (%)||95% Confidence Interval|Mean
1419340|NCT01104584|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).|||sensitivity (%)||95% Confidence Interval|Mean
1419341|NCT01104584|Primary|Difference of Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 390 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SoT).|||difference in sensitivity (%)||95% Confidence Interval|Mean
1419342|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||pg/mL||Standard Deviation|Mean
1419343|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||pg/mL||Standard Deviation|Mean
1419344|NCT01104558|Secondary|Change From Baseline in Pro-BNP Levels According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||pg/mL||Standard Deviation|Mean
1419357|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1440788|NCT00928954|Primary|Percent Change in Median Eye Speed|Median eye speed during attempted visual fixation by each eye|After 2 weeks of therapy, for both drugs||||Percent change|||Number
1419345|NCT01104558|Secondary|Change From Baseline in Pro-B-type Natriuretic Peptide (BNP) Levels According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|BNP is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function.|Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||picograms (pg)/ milliliter (mL)||Standard Deviation|Mean
1419346|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419347|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419348|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419349|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT after walking DBP at Week 26 minus 6-MWT after walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419350|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419351|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419352|NCT01104558|Secondary|Change From Baseline in DBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419353|NCT01104558|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in DBP was calculated as 6-MWT before walking DBP at Week 26 minus 6-MWT before walking DBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419354|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419355|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419356|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT after walking SBP at Week 26 minus 6-MWT after walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419358|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419359|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419360|NCT01104558|Secondary|Change From Baseline in SBP (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||mmHg||Standard Deviation|Mean
1419361|NCT01104558|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in SBP was calculated as 6-MWT before walking SBP at Week 26 minus 6-MWT before walking SBP at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1419362|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
1419363|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
1419364|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
1419365|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- After Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT after walking heart rate at Week 26 minus 6-MWT after walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
1419366|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
1419367|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
1419368|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||bpm||Standard Deviation|Mean
1419369|NCT01104558|Secondary|Change From Baseline in Heart Rate (6 MWT- Before Walking) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|The change in heart rate was calculated as 6-MWT before walking heart rate at Week 26 minus 6-MWT before walking heart rate at baseline.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Beats per minute (bpm)||Standard Deviation|Mean
1440789|NCT00928954|Primary|Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing||After 2 weeks of therapy, for both drugs||||logMAR|||Number
1419370|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of GRK5-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
1419371|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
1419372|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of G Protein-coupled Receptor Kinase 5 (GRK5)-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
1419373|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-CG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
1419374|NCT01104558|Primary|Change From Baseline in Echocardiographic LVEF According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT||Baseline and Week 26 (or EOT)|"Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
1419375|NCT01104558|Secondary|Change From Baseline in 6-MWT Distance According to the Genetic Polymorphism of Beta-2 Adrenergic Receptor-AG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
1419376|NCT01104558|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or EOT|6 MWT distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26 (or EOT)|"Efficacy ITT population. N (number of participants analyzed) signifies those participants who were evaluated for this measure. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Meter||Standard Deviation|Mean
1419377|NCT01104558|Secondary|Duration of Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Participant analyzed included 1 participant from the efficacy ITT population who was hospitalized once due to heart failure.|||Days|||Number
1419378|NCT01104558|Secondary|Number of Participants With Hospitalization Due to Heart Failure||Baseline to Week 26 (or EOT)|Efficacy ITT population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration.|||Participants|||Number
1419379|NCT01104558|Primary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) According to the Genetic Polymorphism of Beta-1 Adrenergic Receptor-CG at Week 26 or End of Treatment (EOT)||Baseline and Week 26 (or EOT)|"Efficacy intention to treat (ITT) population: all enrolled participants; treated with study drug; did not violate inclusion/exclusion criteria; and received primary efficacy assessment at least once after administration. n signifies number of participants with particular genotype and were evaluated for this outcome at particular time point."|||Percent LVEF||Standard Deviation|Mean
1419380|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-181|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
1419381|NCT01104493|Secondary|Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Study Days 1-29|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
1440823|NCT00928720|Secondary|Depression Using the CES-D||Week 8||||units on a scale||Standard Deviation|Mean
1419382|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
1419383|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom.|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-15|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
1419384|NCT01104493|Secondary|Percentage of Participants Reporting Any Adverse Event.|An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
1419385|NCT01104493|Secondary|Percentage of Participants Reporting Any Solicited Symptom|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
1419386|NCT01104493|Primary|Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.|Study Days 1-8|All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)|||Percentage of participants|||Number
1419387|NCT01104415|Secondary|Change in Urinary 5-Hydroxyindoleacetic Acid (HIAA)|The change from baseline value was calculated as the difference between mean change in 5-HIAA of the post-baseline interval and baseline.|Baseline to Week 20-21||||mg/24 hours||Standard Deviation|Mean
1419388|NCT01104415|Secondary|Change in Number of Cutaneous Flushing Episodes||Baseline up to Week 24||||Number of flushing episodes||Standard Deviation|Mean
1419389|NCT01104415|Secondary|Change From Baseline in Weekly Level of Abdominal Pain or Discomfort||Baseline to Week 24||||units on a scale||Standard Deviation|Mean
1419390|NCT01104415|Secondary|Number of Patients Reporting Adequate Relief||Week 24||||Participants|||Count of Participants
1419391|NCT01104415|Secondary|Change From Baseline in Weekly Sensation of Nausea||Baseline to Week 24||||units on a scale||Standard Deviation|Mean
1419392|NCT01104415|Secondary|Change From Baseline in Weekly Sensation of Urgency to Defecate||Baseline to Week 24||||percentage of days||Standard Deviation|Mean
1419393|NCT01104415|Secondary|Change in Weekly Stool Form|Assessed using using a 6-point scale (0-none, 1-hard, 2-firm, 3-soft, 4-loose, 5-watery).|Baseline up to Week 24||||units on a scale||Standard Deviation|Mean
1419394|NCT01104415|Secondary|Change in Weekly Bowel Movements||Baseline up to Week 24||||number of bowel movements||Standard Deviation|Mean
1419395|NCT01104415|Secondary|Change in Urinary 5-Hydroxyindoleacetic Acid (HIAA)||Week 12||||mg/24 hours||Standard Deviation|Mean
1419396|NCT01104415|Secondary|Change in Daily Number of Cutaneous Flushing Episodes|Cutaneous flushing response rate derived for each participant using the daily number of cutaneous flushing episodes and defined as follows: a reduction from Baseline in the daily number of cutaneous flushing episodes of ≥30%, and an absence of octreotide rescue treatment during the interval that cutaneous flushing response criteria were met. The change from baseline value was calculated as the difference between mean numbers of cutaneous flushing episodes of the post-baseline interval and baseline.|Baseline up to Weeks 9-12||||Number of flushing episodes||Standard Deviation|Mean
1419397|NCT01104415|Secondary|Change in Daily Severity of Abdominal Pain or Discomfort|The mean severity of abdominal pain or discomfort based on a 100-mm VAS scale. The VAS component rates on a scale from 0 millimeter (mm) = worst imaginable to 100 mm =best imaginable higher scores indicate a better health state. The change from baseline value was calculated as the difference between mean score of the post-baseline interval and baseline.|Baseline up to Weeks 9-12||||units on a scale||Standard Deviation|Mean
1419398|NCT01104415|Secondary|Number of Patients With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome||Weeks 9-12||||Participants|||Count of Participants
1419399|NCT01104415|Secondary|Change in Sensation/Severity of Nausea|Sensation/severity of nausea was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the sensation/severity of nausea experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The change from baseline value was calculated as the difference between mean score of the post-baseline interval and baseline.|Baseline up to Weeks 9-12||||units on a scale||Standard Deviation|Mean
1419400|NCT01104415|Secondary|Change in Proportion of Days With Sensation of Urgency to Defecate|The change from baseline value was calculated as the difference between mean percentage of days of the post-baseline interval and baseline.|Baseline up to Weeks 9-12||||percentage of days||Standard Deviation|Mean
1419401|NCT01104415|Secondary|Change in Weekly Stool Form|Assessed using a 6-point scale (0-none, 1-hard, 2-firm, 3-soft, 4-loose, 5-watery). The change from baseline value was calculated as the difference between mean score of the post-baseline interval and baseline.|Baseline up to Weeks 9-12||||units on a scale||Standard Deviation|Mean
1419402|NCT01104415|Secondary|Change in Number of Bowel Movements|The change from baseline value was calculated as the difference between mean numbers of BMs of the post-baseline interval and baseline.|Baseline up to Weeks 9-12||||number of bowel movements||Standard Deviation|Mean
1419632|NCT01101867|Secondary|Change in Glucose|Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.|72 hour|intention to treat population|||mg/dl||Standard Deviation|Mean
1419404|NCT01104415|Primary|Number of Patients With Any Drug-related Treatment-emergent Adverse Event|An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant, participating in a clinical study with study drug, regardless of causal relationship.|Baseline, up to 12 weeks||||Participants|||Count of Participants
1419405|NCT01104402|Secondary|Serious Adverse Events (SAE)|Adverse event rates will be coded by body system and MedDRA classification term. Adverse events will be tabulated by treatment group and will include the number of subjects for whom the event occurred, the rate of occurrence, and the severity and relationship to study participation or study procedures.|12 months||||proportion of participants with SAEs|||Number
1419406|NCT01104402|Secondary|Change in Prevalence of Resistant Species of Bacteria|Change in prevalence of resistant species of bacteria (Methicillin Resistant S. aureus, Pseudomonas aeruginosa, Burkolderia cepacia, Stenotrophomona maltophilia, Achromobacterxylosoxidans) in sputum between baseline and final visit (Visit 5 or early withdrawal) will be summarized by treatment group.|12 months||||percentage of subjects with new MRPA|||Number
1419407|NCT01104402|Secondary|Treatment Burden|Change in treatment burden as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. Scores range from 0-100 with higher scores indicating less treatment burden.|Change from baseline to 12 months||||units on a scale||Standard Deviation|Mean
1419408|NCT01104402|Secondary|Change in Health Related Quality of Life Scores as Assessed by the Cystic Fibrosis Questionnaire Revised (CFQ-R) (Respiratory Subscale Only(|Change in health related quality of life as measured by the Cystic Fibrosis Questionnaire revised (CFQ-R)will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The CFQ-R measures functioning in a variety of domains, including Physical Functioning, Vitality, Health Perceptions, Respiratory Symptoms, Treatment Burden, Role Functioning, Emotional Functioning, and Social Functioning. Only the respiratory subscale of the the CFQ-R was evaluated. This ranges from 0 to 100 with higher scores indicating better respiratory quality of life. A negative number indicates a decrease in respiratory quality of life.|Change from baseline to 12 months||||units on a scale||Standard Deviation|Mean
1419409|NCT01104402|Secondary|Pulmonary Exacerbations|Percentage of participants who experienced at least one acute pulmonary exacerbation|12 months||||percentage of participants|||Number
1419410|NCT01104402|Secondary|Cystic Fibrosis Respiratory Symptom Diary (CFRSD)|Change in CF respiratory symptoms as measured by the CFRSD. The CFRSD consists of 8 items which quantify symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recovery from an exacerbation. The CFRSD also includes emotional and activity impacts. Emotional impacts include frustration, sadness/depression, irritability, worry, and difficulty sleeping. Activity impacts include time spent sitting or lying down, reduction of usual activities, and missing school or work. will be analyzed using a linear mixed effects model incorporating baseline randomization factors FEV1 (<50%, 50-75%, and >75% predicted) and age (14-18 & 19+), treatment group, time (in weeks) and the interaction between treatment and time. The range of scores is 8 to 40 with higher scores indicating more severe symptoms.|12 months||||units on a scale||Standard Deviation|Mean
1419411|NCT01104402|Primary|Change in FEV1|The primary outcome variable is FEV1 which will be obtained at quarterly study visits. The primary analysis will use a linear mixed effects model incorporating all FEV1 measurements to estimate the 52-week change in FEV1|12 months||||Liters||95% Confidence Interval|Mean
1419412|NCT01104376|Primary|Measure Efavirenz Clearance|Effect of steady-state voriconazole on efavirenz Clearance in healthy volunteers (n=61) administered a single 100 mg oral dose of efavirenz at baseline (control phase) and after treatment with voriconazole to steady-state.|Baseline, 30 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after efavirenz||||ml/min/kg||Standard Deviation|Mean
1419413|NCT01104311|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events|24 Weeks|The number of participants are analyzed by Safety population.|||participants|||Number
1419414|NCT01104311|Secondary|Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.||24 Weeks|The number of participants are analyzed by ITT population.|||participants|||Number
1419415|NCT01104311|Secondary|Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.||24 Week|The number of participants are analyzed by ITT population.|||events|||Number
1419416|NCT01104311|Secondary|Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.||24 weeks|The number of participants are analyzed by ITT Population.|||participants|||Number
1419417|NCT01104311|Secondary|The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI||24 weeks|The Number of Participants are analyzed by ITT (Intent to treat) Population. ITT Population (Aggressive BP Lowering: 66, Modest BP Lowering: 63)|||participants|||Number
1419418|NCT01104311|Secondary|Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population|the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI|24 weeks|The number of participants are analyzed by FAS population.|||cc||Standard Deviation|Mean
1419419|NCT01104311|Primary|Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)|The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI|Screening to 24 weeks|The Number of Participants Analyzed by FAS(Full analysis)Population. FAS Population (Aggressive BP Lowering: 59, Modest BP Lowering: 52)|||cc||Standard Deviation|Mean
1419420|NCT01104285|Primary|Total Days of Mechanical Ventilatory Support||days||||days||Standard Deviation|Mean
1419421|NCT01104246|Primary|Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours|A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.|Day 28/29|Per-protocol Population was used for the analysis. PP population included subjects who completed the treatment period of the study, who did not have more than two consecutive missing data, and who did not have any major protocol deviations.|||ng/dL||Standard Deviation|Mean
1419423|NCT01104155|Secondary|Overall Survival (OS)|OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS|||Months||95% Confidence Interval|Median
1419424|NCT01104155|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years|FAS|||Percentage of participants||95% Confidence Interval|Number
1419425|NCT01104155|Secondary|Progression-Free Survival (PFS)|PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who had not progressed, and were alive at the date of data cut-off or lost to Follow-up), progression-free survival was censored. Participants who did not progress in their disease were censored on the date of their last tumor assessment preceding the start of any additional anticancer therapy. PFS was analyzed using the Kaplan-Meier method.|From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years|FAS|||Months||95% Confidence Interval|Median
1419426|NCT01104155|Secondary|Duration of Response (DOR)|DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.|From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years|FAS|||Months||95% Confidence Interval|Median
1419427|NCT01104155|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR and the corresponding 95% two-sided confidence intervals (CI) were estimated for each treatment regimen using the Clopper-Pearson method for calculating the exact binomial CI. (CR + PR)|From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)|Full analysis set (FAS) (Intent-to-treat population) included all participants who took at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1419428|NCT01104116|Secondary|Change in Lesion Characteristics to Assess Benefit of PET Scans|The secondary outcome that we are interested in studying is the benefit of PET scan as compared to other imaging modalities, such as CT, MRI, and EUS. Thus, Patients will also have CT, MRI, and EUS imaging. We will look at how size, location, and branch of the IPMN lesion on PET compare to these other imaging modalities. The location, size, and pathology results of the actual surgical specimen will serve as the gold standard.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.||||||
1419429|NCT01104116|Primary|Positive and Negative Predictive Value of PET Imaging for Identifying Malignant IPMN|The primary outcome will be to determine the positive and negative predictive values of [18F]-FDG PET imaging for identifying malignant IPMN lesions in patients who are to undergo surgical resection. We will determine the mean SUV that would provide optimal positive predictive value for malignant IPMN. IPMN lesions will be classified categorically as benign (adenoma or borderline ) or malignant (in situ or invasive carcinoma) and PET imaging will be classified categorically as negative or positive, with focal FDG uptake corresponding to pancreatic lesion.|1 month|The principal investigator has left the institution. Data will not be analyzed. Only the demographic information on 1 enrolled subject is available.||||||
1419430|NCT01104103|Secondary|First Stick Success|This outcome will report the number of IV attempts as defined by the tip of the needle piercing the skin. The results for each IV attempt will be an ordinal number between one and three. We will compare the number and percentage of patients in each group (1, 2, or 3 sticks) between the two therapies.|Five minutes (average)||||participants|||Number
1419431|NCT01104103|Primary|Success|This outcome will measure self-reported success at starting the peripheral intravenous lines in the upper extremity of adults. Success is defined as an IV line through which blood may be aspirated and flushes freely without evidence of fluid extravasation. To be successful, the IV must be placed within a maximum of three attempts. We will report the number and percentage of patients with successful for both therapies.|five minutes (average)||||participants|||Number
1419468|NCT01103492|Primary|Number of Participants With Adverse Events|As this is a feasibility trial, the plan is to evaluate safety and efficacy in relation to adverse events in a small population (20 max) of patients.|1 year|There was no analysis of the data. Feasibility study with only one subject enrolled|||partipants|||Number
1419432|NCT01103973|Secondary|Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)|Psychological status is assessed by the Beck Depression Inventory (BDI). The scores range from 0 to 63; a score of 0 being no depression and 63 being severely depressed. Our cut-off for normal was a score of 12 or less, and those with a score of 13 or greater were considered to have symptoms of depression.|1 year|Subjects were evaluated before IVF cycle 1 and cycle 2 if applicable. The N varies per cycle as some patients withdrew from the study or did not have a second cycle.|||Participants|||Count of Participants
1419433|NCT01103973|Primary|Clinical Pregnancy Rates|Presence of normal fetal heart rate and fetal size at 7 weeks gestation.|1 year||||percentage of participants|||Number
1419434|NCT01103960|Secondary|Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.|Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From drug administration until end of treatment plus one day|Treated set included patients who were randomised and took at least one dose of the trial medication in the double-blind treatment period.|||participants|||Number
1419435|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories at 4 Weeks|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|4 weeks|FAS with LOCF|||Number of participants|||Number
1419436|NCT01103960|Secondary|DBP and SBP Control and Response After 4 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 4 weeks|FAS with LOCF|||Number of participants|||Number
1419437|NCT01103960|Secondary|Change From Baseline in SBP After 4 Weeks of Treatment|Seated trough SBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF|||mmHg||Standard Deviation|Mean
1419438|NCT01103960|Secondary|Change From Baseline in DBP After 4 Weeks of Treatment|Seated trough DBP after 4 weeks.|Baseline and 4 weeks|FAS with LOCF|||mmHg||Standard Deviation|Mean
1419439|NCT01103960|Secondary|Number of Patients in Blood Pressure Categories Over Time|BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg.|8 weeks|FAS with LOCF|||Number of participants|||Number
1419440|NCT01103960|Secondary|DBP and SBP Control and Response After 8 Weeks of Treatment|DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg.|Baseline and 8 weeks|FAS with LOCF|||Number of participants|||Number
1419441|NCT01103960|Secondary|Change From Baseline in SBP After 8 Weeks of Treatment|Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF|||mmHg||Standard Error|Least Squares Mean
1419442|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients|Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.|Baseline and 8 weeks|FAS with LOCF and further restricted to the Chinese subgroup|||mmHg||Standard Error|Least Squares Mean
1419443|NCT01103960|Primary|Change From Baseline in DBP After 8 Weeks of Treatment|Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.|Baseline and 8 weeks|Full analysis set (FAS) defined as patients randomised, treated, with a baseline endpoint measurement and at least one post-dose endpoint measurement during the double blind (DB) phase.|||mmHg||Standard Error|Least Squares Mean
1419444|NCT01103934|Secondary|Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.|Baseline and 2 weeks||||units on a scale||Full Range|Median
1419445|NCT01103934|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period|Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.|Baseline and 2 weeks||||units on a scale||Full Range|Median
1419469|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study||||participants|||Number
1419470|NCT01103479|Secondary|Provider Recommendation of CRC Screening|Provider recommendation of CRC Screening based on chart review|6 months following patient enrollment into study||||participants|||Number
1419446|NCT01103713|Other Pre-specified|Summary of Plasma Desethylchloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.|||ng/ml||Standard Deviation|Mean
1419447|NCT01103713|Other Pre-specified|Summary of Plasma Chloroquine Concentration Versus Time|CQ concentrations in the plasma were determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), 336 (Day 14), 504 (Day 21) and 672 (Day 28) post first dose. Note: Assuming hour not specified as 0 hours on Days 7, 14, 21 and 28 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.|||ng/ml||Standard Deviation|Mean
1419448|NCT01103713|Other Pre-specified|Summary of Serum Azithromycin Concentration Versus Time|AZ concentrations in the serum was determined at specified time points as PK endpoints|"Planned time: 0 (Day 0), 48 (Day 2), 50 (Day 2), 56 (Day 2), 168 (Day 7), and 336 (Day 14) hours post the first dose. Note: Assuming hour not specified as 0 hours on Day 7 and Day 14 for planned time post first dose calculation."|Analyses population included all participants who received at least one dose of study medication and had at least one blood sample collected for PK analysis.|||ng/ml||Standard Deviation|Mean
1419449|NCT01103713|Other Pre-specified|Summary of Hemoglobin Concentration: Abnormal Hemoglobin Level|Abnormal hemoglobin level on Day 42 was measured. The hemoglobin levels were measured with HemoCueTM, via finger stick or peripheral blood collection. The reference range was 10-16g/dL. Any value <0.8 times lower limit of normal was considered clinically significant.|Day 42|The safety analysis set consists of participants who received at least one dose of study medication.|||Participants|||Number
1419450|NCT01103713|Other Pre-specified|Incidence of Fever Based on Oral Temperature|Oral temp was taken by the fieldworker through Day 42.|Baseline, Days 1, 2, 7, 14, 21, 28, 35, and 42|ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Participants|||Number
1419451|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Outcome of Birth|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.|||Participants|||Number
1419452|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Complications During Delivery?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.|||Participants|||Number
1419453|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Labor Induced?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 158 participants only.|||Participants|||Number
1419454|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Delivery Assisted by Trained Obstetric Personnel?|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 159 participants only.|||Participants|||Number
1419455|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Mode of Delivery|All participants were followed up for EIU safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.|||Participants|||Number
1419456|NCT01103713|Other Pre-specified|Summary of Pregnancy Outcome: Location of Delivery|All participants were followed up for exposure-in-utero (EIU) safety assessments following delivery or termination of pregnancy.|Following delivery or pregnancy termination|The safety analysis set consists of participants who received at least one dose of study medication. Data was available for 160 participants only.|||Participants|||Number
1419457|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Parasite count per microliter||Standard Error|Mean
1419458|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Parasite count per microliter||Standard Error|Mean
1419459|NCT01103713|Secondary|Number of Asexual P. Falciparum Per Microliter of Blood at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|Parasite counts (actual counts per microliter of blood) was measured at various time points.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Parasite count per microliter||Standard Error|Mean
1419471|NCT01103479|Primary|Colorectal Cancer (CRC) Screening Completion|CRC screening completion via FOBT, FIT or Colonoscopy|within 6 months of provider recommendation||||participants|||Number
1419460|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419461|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|PP population was used. PP is a subset of MITT population who received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419462|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Uncorrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR uncorrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR uncorrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419463|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 28, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 28, 35, and 42|ITT population was used. ITT is defined as all participants who received at least one dose of study medication and who had a baseline blood smear positive for Plasmodium falciparum monoinfection, asexual parasitemia. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419464|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 , Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419465|NCT01103713|Secondary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Days 7, 14, 21, 35, and 42 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Days 7, 14, 21, 35, and 42|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419466|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (PCR Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|PP population was used. PP is a subset of MITT population who had received all 3 days of study medication. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419467|NCT01103713|Primary|Percentage of Participants With Parasitologic Response (Polymerase Chain Reaction (PCR) Corrected) at Day 28 Post First Dose of Study Medication|The proportion of participants with parasitological response was estimated from the Kaplan Meier curve based on the time to the first occurrence of parasitological failure (PCR corrected). A participant will be a parasitological responder if she has a zero parasite count on the Day 7 visit without subsequent recurrence (PCR corrected) through the day of consideration, otherwise she is a parasitological failure.|Day 28|MITT population was used. MITT is a subset of the ITT population who had Plasmodium falciparum monoinfection (confirmed by microscopy) parasite count in the range of 80-100,000/microlitre on their baseline blood smear. Two participants were excluded because they had protocol deviations regarding the informed consent process.|||Percentage of participants||95% Confidence Interval|Number
1419474|NCT01103440|Secondary|Number of Participants With Major Adverse Cardiac Event (MACE)|Number of participants with MACE which is any event of Death, MI, Stent Thrombosis, Urgent Revascularization, Bleeding. Major adverse cardiac events (MACE), defined as the composite of death, MI (CK-MB > 3 times normal), urgent revascularization and definite or probable stent thrombosis (ST) within 30 days. Stent thrombosis was defined according to the new academic research consortium definitions; 2) bleeding complications within 30 days. Major bleeding was defined as intracranial or intraocular bleeding or a drop in hemoglobin > 5 g/dL. Minor bleeding was defined as hemorrhage at the access site requiring intervention, hematoma with a diameter of at least 5 cm, a reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding or transfusion of a blood product.|30 days||||Participants|||Count of Participants
1419475|NCT01103440|Primary|Number of Participants With Elevation of Cardiac Enzyme|Number of participants with peri-procedural biomarker elevation defined as any elevation above baseline of CK-MB or Tn-I within 24 hours after completion of the procedure.|24 hours||||Participants|||Count of Participants
1419476|NCT01103414|Secondary|Changes in LDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on LDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 week|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.|||nM||Standard Deviation|Mean
1419477|NCT01103414|Secondary|Changes in HDL Particle Size Subfractions From Baseline to Week 12|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on HDL particle size profile as characterized by changes in NMR analysis of subfractions following once-daily dosing for 12 weeks|12 weeks|The Modified Per-Protocol Population included all ITT patients who completed the 12-week, double-blind treatment period with no major deviations from protocol procedures, without any study medication non-compliance issues based on their pharmacokinetic data, and with both baseline and post-baseline NMR analysis of lipoprotein particle subfractions.|||nM||Standard Deviation|Mean
1419478|NCT01103414|Secondary|Presence of Edema Post Baseline During 12 Weeks Active Treatment|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on presence of edema following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both a baseline and post baseline edema assessment|||participants|||Number
1419479|NCT01103414|Secondary|Change From Baseline in Waist Circumference at Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on waist circumference following once-daily dosing for 12 weeks|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and had both baseline and week 12 waist circumference assessments|||cm||Standard Deviation|Mean
1419480|NCT01103414|Secondary|Change in Body Weight From Baseline to Week 12 Endpoint|Effects of 3 different doses of Mitoglitazone and pioglitazone as compared to placebo on body weight following once-daily dosing for 12|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||kg||Standard Deviation|Least Squares Mean
1419481|NCT01103414|Secondary|Change From Baseline in RBC|Change from baseline at week 12 endpoint in red blood cell concentration|12 week|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments|||10e-6 cells per uL||Standard Deviation|Mean
1419482|NCT01103414|Secondary|Change From Baseline in Hemoglobin|Change from baseline at week 12 endpoint in hemoglobin concentration|12 weeks|All randomized patients who received at least 1 dose of randomized study medication and who had both baseline and week 12 assessments.|||g/dL||Standard Deviation|Mean
1419483|NCT01103414|Secondary|Change From Baseline to Week 12 Endpoint in Hematocrit|Change from baseline to week 12 endpoint in hematocrit as an indication of fluid retention|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||percentage of volume||Standard Error|Least Squares Mean
1419484|NCT01103414|Secondary|Percent Change From Baseline to Week 12 Endpoint in HMW Adiponectin|Percent change from baseline to week 12 endpoint in high molecular weight adiponectin|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||percentage of baseline values||Standard Deviation|Least Squares Mean
1419485|NCT01103414|Secondary|Change From Baseline in HbA1c|Change from baseline in plasma glucose measured by hemoglobin A1c in response to three different doses of Mitoglitazone and pioglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|12 weeks|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||percentage of hemoglobin||Standard Deviation|Least Squares Mean
1419486|NCT01103414|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12.|Change from baseline in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to pioglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.|Baseline, Week 12|The Modified Per-Protocol Population included all per-protocol patients (all ITT patients who completed the 12-week, double-blind treatment period without any major deviations from the protocol procedures) without any study medication non-compliance issues based on their pharmacokinetic data.|||mg/dL||Standard Error|Least Squares Mean
1419487|NCT01103362|Primary|The Frequency of Adverse Events||A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD||||percentage of patients-any adverse event|||Number
1419488|NCT01103323|Secondary|Tumor Response|A tumor response (best overall response) was defined for all patients, using the RECIST criteria, version 1.1. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased at least 30% from baseline), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions). Clinical PD considered when radiographic imaging not possible.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Percentage of participants|||Number
1419489|NCT01103323|Secondary|Disease Control|Disease control was defined as the percentage of patients whose best response was not PD [sum of lesion sizes increased at least 20% from smallest sum on study or new lesions] (ie, CR [tumor disappears], PR [sum of lesion sizes decreased at least 30% from baseline] or SD (stable disease)). SD included if at least 6 weeks after randomization.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Percentage of participants|||Number
1419490|NCT01103323|Secondary|Objective Tumor Response|The objective tumor response was defined as the percentage of patients with complete response (CR, tumor disappears) or partial response (PR, sum of lesion sizes decreased at least 30% from baseline) as best overall response. A best overall response was defined for all patients, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. Patients whose best overall response was not CR or PR, and any patients with no post-baseline assessments were considered nonresponders for the analysis.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Percentage of participants|||Number
1419491|NCT01103323|Secondary|Progression-free Survival (Based on Investigator’s Assessment)|Progression-free survival was defined as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.|ITT|||Days||95% Confidence Interval|Median
1419492|NCT01103323|Primary|Overall Survival|Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.|From randomization of the first subject until the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).|Intent to treat (ITT)|||Days||95% Confidence Interval|Median
1419493|NCT01103284|Secondary|Mean Number of Days With at Least One Hypoglycemic Event||Baseline to 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit|||days||Standard Error|Mean
1419494|NCT01103284|Secondary|Frequency of Hypoglycemic Events|Total number of days with at least one hypoglycemic event recorded|Baseline to 25 Months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit|||days|||Number
1419495|NCT01103284|Other Pre-specified|Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study|Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.|||percentage of subjects||95% Confidence Interval|Number
1419496|NCT01103284|Secondary|Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%|The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.|24 and 25 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit.|||percentage of subjects||95% Confidence Interval|Number
1419497|NCT01103284|Primary|Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months|Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.|Baseline and 24 months|Full Analysis Set (FAS) All subjects randomized who had a baseline visit and at least one scheduled post-baseline visit|||nmol*min/L||Standard Error|Mean
1419498|NCT01103271|Secondary|Pre-Post Efficacy|The magnitude of the pre-post effect across 4 weeks of treatment, as measured by the Hamilton Rating Scale for Depression-17 (HAMD-17). The HAMD-17 measures depression severity, and has a minimum value of 0 and a maximum value of 52 units on a scale, where higher scores indicate more severe depression.|Screen and 4 weeks (immediate treatment); Baseline and 4 weeks (waitlist treatment)||||units on a scale||Standard Deviation|Mean
1419499|NCT01103271|Primary|Feasibility|The primary outcome measure is feasibility, which was operationalized as the number of in-person screens for this study.|One year|The number of participants analyzed is the number of participants screened.|||screens|||Number
1419500|NCT01103232|Primary|Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles|Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.|6 weeks (The change calculated as 6 months minus baseline)||||Newton meters||Standard Deviation|Mean
1419511|NCT01103063|Secondary|Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation|Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with lab test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
1419501|NCT01103141|Primary|Major Peripheral Vascular Events|Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral|7 - 14 days||||participants|||Number
1419502|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.|||Percentage of participants|||Number
1419503|NCT01103063|Secondary|Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae|This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.|Visits 6 and 7|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participant with nasopharyngeal swabs isolating Streptococcus pneumoniae at the specified visit.|||Percentage of participants|||Number
1419504|NCT01103063|Secondary|Percentage of Participants With Pre-eclampsia From Week 20 to Delivery|Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.|From Week 20 to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N= Number of participants with available data.|||Percentage of participants||95% Confidence Interval|Number
1419505|NCT01103063|Secondary|Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery|Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.|Up to approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.|||Percentage of participants||95% Confidence Interval|Number
1419506|NCT01103063|Secondary|Percentage of Neonates With Ophthalmia Neonatorum at Birth Period|Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Total live births.|||Percentage of neonates||95% Confidence Interval|Number
1419507|NCT01103063|Secondary|Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.|Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
1419508|NCT01103063|Secondary|Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation|Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
1419509|NCT01103063|Secondary|Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation|Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
1419510|NCT01103063|Secondary|Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation|Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N=Number of participants with laboratory test results at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
1419566|NCT01102777|Secondary|Goal Commitment for Intervention Participants|"Change in goal commitment for intervention participations on a Likert scale from 1-5, with 1 as Strongly Disagree and 5 is Strongly Agree to the question, I am strongly committed to pursuing my step count goal. A negative change value indicates lower goal commitment."|change from four months and twelve months from enrollment|This measure was only assessed on the Intervention group, and only 146 participants answered the question at either time points.|||units on a scale||95% Confidence Interval|Mean
1419512|NCT01103063|Secondary|Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation|Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.|Upto 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.|||Percentage of participants||95% Confidence Interval|Number
1419513|NCT01103063|Secondary|Percentage of Participants With Cord Blood Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with cord blood smear parasite counts at delivery.|||Percentage of participants||95% Confidence Interval|Number
1419514|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at Delivery|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at delivery.|||Percentage of participants||95% Confidence Interval|Number
1419515|NCT01103063|Secondary|Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation|This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was >0.|At 36-38 weeks of gestation|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus. N = Number of participants with peripheral blood smear parasite counts at 36-38 weeks of gestation.|||Percentage of participants||95% Confidence Interval|Number
1419516|NCT01103063|Secondary|Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery|This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.|||Percentage of participants||95% Confidence Interval|Number
1419517|NCT01103063|Secondary|Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery|This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever >37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 is considered the first dose of study medication), and who had a single fetus.|||Number of episodes||95% Confidence Interval|Least Squares Mean
1419518|NCT01103063|Secondary|Birth Weight of Live Borne Neonate|Birth weight of live borne neonates were calculated in grams.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of live births with available data.|||grams||95% Confidence Interval|Least Squares Mean
1419519|NCT01103063|Secondary|Percentage of Perinatal or Neonatal Deaths|Percentage of perinatal or neonatal deaths were noted.|Day 28 after delivery.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.|||Percentage of neonates||95% Confidence Interval|Number
1419520|NCT01103063|Secondary|Percentage of Neonates With Congenital Abnormalities at Birth|Neonates with congenital abnormalities at birth were noted.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of total live births.|||Percentage of neonates||95% Confidence Interval|Number
1419521|NCT01103063|Secondary|Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.|Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.|Baseline, at 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.|||g/dL||95% Confidence Interval|Least Squares Mean
1419522|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation|Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight <2,500g), premature birth (<37 weeks), abortion (≤28 weeks), still birth (>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total Outcomes.|||Percentage of participants||95% Confidence Interval|Number
1419567|NCT01102777|Secondary|Change in Average Daily Step Counts|Change in daily step counts compared to baseline and those captured in the final two weeks of the intervention and the two weeks post intervention.|baseline and final two weeks of the intervention and the two weeks post intervention.|One Intervention participant was dropped from analysis due to being an extreme outlier.|||steps||95% Confidence Interval|Mean
1419523|NCT01103063|Secondary|Sexually Transmitted Infection (STI) Episodes Per Participant|Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).|Approximately 40 weeks of gestational age .|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with available data.|||Number of episodes||95% Confidence Interval|Least Squares Mean
1419524|NCT01103063|Secondary|Percentage of Participants With Placental Malaria at Delivery Based on Histology|Participants positive for placental malaria at delivery were evaluated based on placental histology.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with a histology parasite evaluation at delivery.|||Percentage of participants||95% Confidence Interval|Number
1419525|NCT01103063|Secondary|Percentage of Participants With Placental Parasitemia at Delivery|Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with placental parasite counts at delivery.|||Percentage of participants||95% Confidence Interval|Number
1419526|NCT01103063|Secondary|Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation|Anemia was defined as Hb <11 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.|||Percentage of Participants||95% Confidence Interval|Number
1419527|NCT01103063|Secondary|Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation|Severe maternal anemia was defined as Hb <8 g/dL.|At 36-38 weeks of gestation.|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Number of participants with Hb measurement at 36-38 weeks gestation.|||Percentage of participants||95% Confidence Interval|Number
1419528|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care. N=Total Live Births.|||Percentage of neonates||95% Confidence Interval|Number
1419529|NCT01103063|Secondary|Percentage of Neonates With LBW (<2500 g) in ITT Population|LBW was defined as live birth weight <2500 g (up to and including 2499 g).|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus. N=Total live births.|||Percentage of neonates||95% Confidence Interval|Number
1419530|NCT01103063|Secondary|Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (<2,500g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|Subset of ITT participants: outcome or withdrawal occurred on or before 8/27/2013 (date of study termination), compliant with study medication, birth weight measured on or before 7 days after birth if not already a failure, and did not switch to standard of care.|||Percentage of Participants||95% Confidence Interval|Number
1419531|NCT01103063|Primary|Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population|Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (<2,500 g), premature births (<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.|Approximately 40 weeks of gestational age|ITT set was used which consisted of participants who were randomized, received at least one dose of study medication (Day 0 at Visit 1 was considered the first dose of study medication), and who had a single fetus.|||Percentage of participants||95% Confidence Interval|Number
1419532|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 48|Safety Population|||participants|||Number
1419533|NCT01102972|Secondary|Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE.|From Baseline to Week 24|Safety Population|||participants|||Number
1419568|NCT01102777|Secondary|Days of Hospitalization|Number of days of all-cause hospitalization during study participation.|during study participation, up to 12 months||||days|||Number
1419633|NCT01101867|Secondary|Hypoglycemia|Number of patients with any hypoglycemic event (<70 mg/dl or <40 mg/dl)|72 hour||||participants|||Number
1419534|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 48 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.|||participants|||Number
1419535|NCT01102972|Secondary|Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir|A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria with viral phenotype obtained at the time of virologic failure were assessed.|||participants|||Number
1419536|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 48|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 48|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.|||participants|||Number
1419537|NCT01102972|Secondary|Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24|A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.|From Baseline to Week 24|ITT-E Population. Only those participants who met the confirmed VF criteria and had a viral genotype obtained at the time of VF were assessed.|||participants|||Number
1419538|NCT01102972|Secondary|Number of Participants Who Experienced Death and/or Disease Progression|Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions.|From Baseline to Week 48|ITT-E Population|||participants|||Number
1419539|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 48|The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 48|ITT-E Population|||participants|||Number
1419540|NCT01102972|Secondary|Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24|The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL.|From Baseline to Week 24|ITT-E Population|||participants|||Number
1419541|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 48|A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.|||ratio||Standard Deviation|Mean
1419542|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 48|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter.|Baseline and Week 48|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a measurement taken during that visit period.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1419543|NCT01102972|Secondary|Change From Baseline in Cholesterol/HDL Ratio at Week 24|A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.|||ratio||Standard Deviation|Mean
1419843|NCT01099761|Secondary|Change From Baseline in Time to Travel 10 Meters (Standardized 10-Meter-Walk/Run Test).||Baseline to End-of-Study Visit, approximately 24 weeks later.||||Change (sec) in 10MWT from baseline||Standard Deviation|Mean
1419544|NCT01102972|Secondary|Change From Baseline in Fasting Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24|Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter.|Baseline and Week 24|Safety Population: all randomized participants, with the exception of those with documented evidence of not having consumed any Investigational Product. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a measurement taken during that visit period.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1419545|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 48|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 48 value minus the Baseline value.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a CD4+ cell count obtained during that visit period.|||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
1419546|NCT01102972|Secondary|Change From Baseline in CD4+ Cell Count at Week 24|Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 24 value minus the Baseline value.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a CD4+ cell count obtained during that visit period.|||cells per cubic millimeter (mm^3)||Standard Deviation|Mean
1419547|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 48|Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 48|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 48 visit and had a viral load result obtained during that visit period.|||log10 copies/mL||Standard Deviation|Mean
1419548|NCT01102972|Secondary|Change From Baseline in HIV-1 RNA at Week 24|Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load.|Baseline and Week 24|ITT-E Population. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 24 visit and had a viral load result obtained during that visit period.|||log10 copies/mL||Standard Deviation|Mean
1419549|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.|||Percentage of participants|||Number
1419550|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) MD=F: PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=400 c/mL were failures.|||percentage of participants|||Number
1419551|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 48 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 48|ITT-E Population|||Percentage of participants|||Number
1419552|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit.|Week 24|ITT-E Population. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <400 copies/mL at Week 24.|||percentage of participants|||Number
1419553|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 48 Visit: TLOVR, Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 48|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.|||Percentage of participants|||Number
1419587|NCT01102413|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.||Baseline, 4 weeks|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
1419588|NCT01102374|Secondary|Number of Other Infections||12 months||||events|||Number
1419554|NCT01102972|Secondary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods.|Week 24|ITT-E Population. Analysis methods: (1) Observed: all observed data; (2) missing or discontinuation equals failure (M/D=F): PAR with missing data/data collected after study medication discontinuation (DC) were failures; (3) SNAPSHOT: PAR with missing data at Week 24/data collected after study medication DC/viral load >=50 c/mL were failures.|||percentage of participants|||Number
1419555|NCT01102972|Primary|Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis|The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit.|Week 24|Intent-to-Treat (ITT)-Exposed Population: all participants exposed to at least one dose of study medication. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of participants HIV-1 RNA <50 copies/mL at Week 24.|||percentage of participants|||Number
1419556|NCT01102894|Secondary|Food Intake Diary|Total dietary fiber consumed.|Day 1|Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake|||g||Standard Deviation|Mean
1419557|NCT01102894|Secondary|Gastrointestinal Tolerance|Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.|Day 4|Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.|||units on a scale||Standard Deviation|Mean
1419558|NCT01102894|Primary|Whole Gut Transit Time|The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.|5 days|All participants had their transit time assessed.|||hours||Standard Deviation|Mean
1419559|NCT01102803|Secondary|Behavioral Avoidance Test (BAT)|During the initial screen, at post-treatment, and at follow-up, participants underwent a behavioral avoidance test in the virtual reality height environment. Participants reported on a 0–100 scale (100 being the most intense fear) their SUDS for floors 1, 2, 3, 4, 9, 19 of the virtual glass elevator and balconies. This test has been used successfully as a measure of treatment gains in previous studies of acrophobia research (Ressler et al., 2004). For the outcome analyses, we included the level of fear reported at the highest floor of the virtual elevator environment (19th floor). Higher scores indicate a worse outcome.|2 months||||units on a scale||Standard Deviation|Mean
1419560|NCT01102803|Secondary|Clinical Global Improvement Scale (CGI)|Clinician-rated measure of improvement in acrophobia symptoms and severity. Will be assessed at each visit throughout the 2 month protocol. The CGI-S and CGI-I are widely used measures of global psychopathology severity and improvement initially developed for the study of psychotropic drugs (Guy, 1970). In order to obtain CGI ratings, the therapists (blind to study condition) interviewed the participant and used the SCID (including the specific phobia module) as well as the additional measures of acrophobia symptoms (BAT, AAQ, AAVQ, and ATHQ). In the current study, response was defined as either “very much improved” or “much improved” on CGI-I (score ≤ 2). Remission was defined as either “normal” or “minimally ill” on CGI-S (score ≤ 2). The minimum rating is a 1 and the highest is a 7. Lower scores indicate a better outcome.|2 months||||units on a scale||Standard Deviation|Mean
1419561|NCT01102803|Secondary|Attitudes Towards Heights Questionnaire (ATHQ)|Self-report measures that assesses thoughts and feelings towards heights situations. This questionnaire (Abelson and Curtis, 1989) includes six heights situations and assesses attitudes toward these situations using a 0–10 scale. Higher scores indicate a worse outcome and total scores are summed over subscales. Will be assessed at each visit throughout the 2 month protocol. The minimum score is a 0; the maximum is a 60.|2 months||||units on a scale||Standard Deviation|Mean
1419562|NCT01102803|Primary|Acrophobia Questionnaire With Avoidance (AAVQ)|Self-report measure that assesses fear and avoidance of a variety of heights situations. This questionnaire (Cohen, 1977) describes 20 situations and assesses levels of avoidance (0–3) and anxiety (0–6). These scales widely used measure of acrophobia with adequate retest reliability (r = .82–.86) and validity (Baker et al., 1973). Higher scores indicate higher levels of avoidance/anxiety (i.e., worse outcome). All subscales are summed for a total score. AAVQ will be assessed at each visit throughout the 2 month protocol. The minimum score is 0, the maximum is 90.|2 months||||units on a scale||Standard Deviation|Mean
1419563|NCT01102777|Secondary|Change in Participant Satisfaction|"Change in participation satisfaction with the Intervention group from four to twelve months on a Likert scale of 1-5, where 1 is Definitely True 5 is Definitely False to the question, I would recommend the Taking Healthy Steps walking program to another person with COPD. A negative change value indicates higher satisfaction score."|four to twelve months of study participation|This was only assessed on Intervention group participants who answered the question at either four or twelve months.|||units on a scale||95% Confidence Interval|Mean
1419564|NCT01102777|Secondary|Participant Retention|The last valid day of pedometer data or the last login day to the study website for both arms, whichever day was last, from 1-366.|during study participation, up to twelve months||||day||95% Confidence Interval|Mean
1419565|NCT01102777|Secondary|Study Reach Among Rural Participants|Calculated by dividing the total number of eligible rural responders by the total number of rural responders to create an eligibility rate, then multiplying the eligibility rate with the total number of letters sent to rural individuals to create a possible rural eligible pool. The total number of eligible rural responders was divided by the possible rural eligible pool.|At baseline|number of rural participants.|||percentage of possible eligible rural|||Number
1419589|NCT01102374|Secondary|Number of Urinary Tract Infections||12 months||||events|||Number
1419590|NCT01102374|Secondary|Death||12 months||||Participants|||Count of Participants
1419591|NCT01102374|Secondary|Incident Hypercalcemia||12 months||||Participants|||Count of Participants
1419592|NCT01102374|Secondary|Incident Kidney Stones||12 months||||Participants|||Count of Participants
1419569|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 12 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Nine Control and seventeen Intervention participants were missing data at 12 months.|||units on a scale||Standard Deviation|Mean
1419570|NCT01102777|Secondary|Self Reported Dyspnea|"Change in Self Reported Dyspnea from Baseline to 4 months. (Scores range from 0 to 4, with higher scores indicating more shortness of breath. For example, 0 - I only get breathless with strenuous exercise. and 4 - I am too breathless to leave the house or I am breathless when dressing.)"|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. Three Control and ten Intervention were missing values at 4 months.|||units on a scale||Standard Deviation|Mean
1419571|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George’s Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|twelve months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier.|||units on a scale||95% Confidence Interval|Mean
1419572|NCT01102777|Primary|Self-Reported Respiratory-Specific Quality of Life|Change in St. George’s Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.)|four months from randomization|One Intervention participant was dropped from analysis due to being an extreme outlier. In addition, not all participants had complete SGRQ data at both time points for analysis.|||units on a scale||Standard Deviation|Mean
1419573|NCT01102764|Secondary|Prior Experience With Computer and Audiovisual Technology: Short Measure to Learn More About Participants' Prior Experience and Comfort Level With Computers and Audiovisual Technology||1 year|||||||
1419574|NCT01102764|Secondary|Structured Clinical Interview for DSM-IV: Interview to Diagnosis Depression, Panic Disorder, and Substance Abuse||1 year|||||||
1419575|NCT01102764|Secondary|Service Delivery Perceptions Questionnaire: Assess Subjects' Perceptions About Variables Specifically Related to the Mode of Service Delivery (Quality of Communication, Ease of Use, Willingness to Use Treatment)||1 year|||||||
1419576|NCT01102764|Secondary|Treatment Credibility: to Assess for Differences in Outcome Expectancy, Treatment Credibility Scales||1 year|||||||
1419577|NCT01102764|Secondary|Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA): 16 Item Self Report Scale, General Measure of Patient Satisfaction of Treatment||1 year|||||||
1419578|NCT01102764|Secondary|Health Related Functioning: Medical Outcome Study Short Study Forms-36 Health Survey (SF 36): Self Report Scale Measures Health Status and Functioning Over the Past Four Weeks||1 year|||||||
1419579|NCT01102764|Secondary|Deployment Risk and Resiliency Inventory (DRRI): Self Report Measure Assessing 14 Key Deployment-related Risk and Resilience Factors With Demonstrated Implications for Veterans' Long Term Health||1 year|||||||
1419580|NCT01102764|Secondary|Clinician Administered PTSD Scale (CAPS): PTSD Diagnosis||1 year|||||||
1419581|NCT01102764|Primary|BDI Scores at Pre and Post Treatment|Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||units on a scale||Full Range|Mean
1419582|NCT01102764|Primary|PCL Scores at Pre and Post Treatment|PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. Total scores on the PCL range from 17 to 85 (lower scores indicate less symptom severity). The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). The minimum score possible on this measure is 17, and the highest possible score is 85.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||units on a scale||Full Range|Mean
1419583|NCT01102764|Primary|The Major Objective of This Study is to Determine if PE Delivered Via Telemedicine is as Effective as In Person PE in Terms of (1) Clinical (PTSD and Depression); (2) Process (Treatment Satisfaction and Attrition); and (3) Economic (Cost) Outcomes.|Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions. Per protocol, participants could have as many as 12 treatment sessions.|6 months|There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.|||sessions||Full Range|Mean
1419584|NCT01102491|Secondary|Incidence of Rescue Antiemetic Administration|outcome assessor assessed the incidence of rescue antiemetic administration|within 48 hours after surgery|||||||
1419585|NCT01102491|Primary|Incidence of Nausea and Vomiting|outcomes assessor who is blinded to randomization assessed the incidence of postoperative nausea which was defined as subjectively unpleasant sensation associated with awareness of the urge to vomit and an emetic episode and vomiting|within 48 hours after surgery||||participants|||Number
1419586|NCT01102413|Secondary|Change in Hemoglobin Concentration From Baseline to Week 8||Baseline to week 8|The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.|||g/dL||Full Range|Mean
1419604|NCT01102270|Primary|Apnea Hypopnea Index|number of respiratory events per hour of sleep Respiratory events last for at least 10 seconds and are associated with a decrease in blood oxygenation or a cortical arosual from sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe|8 hour In-Laboratory Polysomnogram (PSG)||||events per hour of sleep||Standard Error|Mean
1419605|NCT01102270|Secondary|Nadir Overnight Oxygen Saturation|Nadir overnight oxygen saturation (%)|8 hour In-Laboratory Polysomnogram (PSG)||||% oxygen saturation||Standard Error|Mean
1419606|NCT01102270|Secondary|Arousal Threshold|quantified using an epiglottic pressure transducer in CmH2O|8 hour In-Laboratory Polysomnogram (PSG)||||cmH2O||Inter-Quartile Range|Median
1419607|NCT01102257|Primary|Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content||Baseline and 3 Months||||Percentage Total Fatty Acids||Inter-Quartile Range|Median
1419608|NCT01102257|Secondary|Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines||90 +/- 14 days following initiation of drug regimen|||||||
1419609|NCT01102257|Secondary|Change in Schirmer’s||90 +/- 14 days following initiation of drug regimen|||||||
1419610|NCT01102257|Secondary|Change in the Ocular Surface||90 +/- 14 days following initiation of drug regimen|||||||
1419611|NCT01102257|Secondary|Change in Quality of Life Associated With Chronic Pain||90 +/- 14 days following initiation of drug regimen|||||||
1419612|NCT01102257|Secondary|Change on Impact of Dry Eye on Everyday Life (IDEEL)||90 +/- 14 days following initiation of drug regimen|||||||
1419613|NCT01102257|Secondary|Change on Brief Ocular Discomfort Inventory (BODI)||90 +/- 14 days following initiation of drug regimen|||||||
1419614|NCT01102257|Primary|Change on Ocular Surface Disease Index (OSDI)||90 +/- 14 days following initiation of drug regimen|||||||
1419615|NCT01102218|Secondary|Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6||6 months|||||||
1419616|NCT01102218|Secondary|Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time||6 months|||||||
1419617|NCT01102218|Primary|Change in Erythropoietin Dose|Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.|Baseline and 6 months|The number of patients for analysis was based on those patient who had completed 6 months of treatment. The analysis was per protocol.|||Units EPO||Standard Deviation|Mean
1419618|NCT01102140|Secondary|Asymmetric Dimethylarginine (ADMA)|ADMA is a serum enzyme involved in metabolism of endothelium derived nitric oxide (NO). NO's has an important role in maintaining endothelial homeostasis. Elevated ADMA levels suggest impaired endothelial function.|baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain ADMA values due to PI departure from study center prior to any batches being sent for analysis||||||
1419619|NCT01102140|Secondary|Procollagen Types I (PINP) and III (PIIINP)|This is a serum marker of collagen turnover (fibrosis/scar formation).|baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain procollagen values due to PI departure from study center prior to any batches being sent for analysis||||||
1419620|NCT01102140|Secondary|F-8 Isoprostanes|This is a serum marker of oxidative stress.|Baseline and 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis||||||
1419621|NCT01102140|Primary|Thiobarbituric Reactive Substances (TBARS)|This is a serum marker of oxidative stress.|baseline and after 12 weeks|Serum samples were obtained and frozen but never analyzed to obtain isoprostane values due to PI departure from study center prior to any batches being sent for analysis.||||||
1419622|NCT01101971|Primary|Score on Pelvic Exam Assessment Tool|A pelvic exam assessment score out of 30 is recorded by a Resident examiner immediately after a student completes their first pelvic examination on a mock patient. Pass = 15/30 (50%).|15 minutes||||points||Standard Deviation|Mean
1419623|NCT01101958|Primary|Lung Volume Change||30 Days|Per protocol population analyzed [16 subjects have been excluded due to the following reasons: lacked HRCT(n=6), Lost to Follow-Up (n=8) or died (n=2) of unrelated causes].|||percent decrease in lung volume||Inter-Quartile Range|Median
1419624|NCT01101880|Primary|Overall Survival|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.|Up to 5 years||||months||95% Confidence Interval|Median
1419625|NCT01101880|Primary|Treatment-related Mortality (TRM)|Treatment-related mortality (TRM) data was not collected.|Up to 5 years|Treatment-related mortality (TRM) data was not collected.||||||
1419626|NCT01101880|Primary|Event Free Survival|Number of patients in remission at a median follow up of 15 months.|Up to 5 years||||Participants|||Count of Participants
1419627|NCT01101880|Primary|Time to Progression|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates.|Up to 5 years||||weeks||Full Range|Median
1419628|NCT01101880|Primary|Duration of Remission|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Remission is defined as less than 5% blasts in the bone marrow, no appearance of blasts in the peripheral blood, and no extramedullary disease (appearance of leukemic cells in other tissues).|Up to 5 years||||weeks||Full Range|Median
1419629|NCT01101880|Primary|Rates of Complete Remission and Complete Remission With Incomplete Recovery of Counts|With 50 patients, the rates of these endpoints will be estimated with a standard error of 5 to 7 percentage points, depending on the observed rates. Complete remission is defined as less than 5% blast cells present in the bone marrow and count recovery (absolute neutrophil count greater than 1000/microL and platelet count greater than 100,000/microL). Complete remission with incomplete recovery of counts is defined as less than 5% blast cells present in the bone marrow without compete count recovery (absolute neutrophil count less than 1000/microL and platelet count less than 100,000/microL).|Up to 5 years|CR achieved with no AHD only applies to those who did not have AHD.|||Participants|||Count of Participants
1419630|NCT01101867|Secondary|1,5-anhydroglucitol Change|change in short-term measure of glycemia|day 1 to day 3|subjects with complete data|||mcg/ml||Standard Deviation|Mean
1420604|NCT01092910|Secondary|QuickSIN|To assess whether the Esteem System is as effective as or better than the pre-implant hearing aid for improving speech discrimination (intelligibility) as shown by the QuickSIN (speech in noise) test results.|4 and 10 Months Post-Activation|||||||
1419635|NCT01101867|Primary|Mean Glucose|Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3|day 3|Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.|||mg/dl||Standard Deviation|Mean
1419636|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity Score per day||Standard Deviation|Mean
1419637|NCT01101841|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||kg/m2||Full Range|Median
1419638|NCT01101841|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject’s total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
1419639|NCT01101841|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).~The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.~Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).~Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).~Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.~The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percentage of participants|||Number
1419640|NCT01101841|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject’s overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)~The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.~Responders: Subjects Achieving a Score of “Very Much Improved” Or “Much Improved” Or “Minimally Improved”.~Non Responders: Subjects with a Score of “No Change” Or “Minimally Worse” Or “Much Worse” Or “Very Much Worse”."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
1419641|NCT01101841|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
1419699|NCT01101022|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 10 weeks post-dose|FAS|||Percent of participants|||Number
1419642|NCT01101841|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score, Median|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.The sum of the scores for all 5 items was calculated at Week 4 and Week 12.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Units on a scale||Full Range|Median
1419643|NCT01101841|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).~Responders: Subjects with NRS Score of 5 Or Less. Non-Responders: Subjects With NRS Score of Greater than Or Equal to 6."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of total number of subjects|||Number
1419644|NCT01101841|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
1419645|NCT01101841|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||units on a scale||Full Range|Median
1419646|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
1419647|NCT01101841|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
1419648|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
1419700|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 10 weeks post-dose|FAS|||Percent of participants|||Number
1419649|NCT01101841|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.~The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Awakenings||Full Range|Median
1419650|NCT01101841|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
1419651|NCT01101841|Secondary|Percent Persistence of Benefit, Statistically Significant Difference in Having 50% or More Reduction Compared to Baseline at Week 24.|"Persistence of treatment benefit to 24 weeks post treatment was assessed by using the following responder analysis. Responders were defined as those subjects who achieved ≥ 50% reduction from baseline in moderate to severe hot-flash frequency at Week 24; the percent change in hot flash frequency is calculated using the formula:~Percent reduction at week 24 = [(number of moderate to severe hot flash frequency at baseline – number of moderate to severe hot flash frequency at week 24) / number of moderate to severe hot flash frequency at baseline ]*100%."|Week 24|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of total number of subjects|||Number
1419652|NCT01101841|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.~The results reported are:~Mean Baseline frequency of moderate to severe VMS~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 12"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per day||Standard Deviation|Mean
1419653|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
1419654|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).||||Subjects|||Number
1419655|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).||||Subjects|||Number
1419656|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).||||Subjects|||Number
1419657|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).||||Subjects|||Number
1419658|NCT01101542|Primary|Number of Subjects With Medically Significant Conditions.|*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance)|*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.||||||
1419659|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.~Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
1419660|NCT01101542|Primary|Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
1419661|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Note: Results for the 5th and 6th year of surveillance will be added when they become available."|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
1419662|NCT01101542|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.|||Subjects|||Number
1419663|NCT01101477|Secondary|The Global Tolerance for Flexible Bronchoscopy|After the recovery, patients will be asked about the tolerance of bronchoscopy performed to them by 10-point Verbal Analogus Scale (0: best tolerance, 10: worst tolerance)|After recovery|||||||
1419664|NCT01101477|Secondary|The Cooperation of Patients From the View of Bronchoscopists|After the bronchoscopy, the bronchoscopist will be asked by 10-point Verbal Analogus Scale (0: the best cooperation, 10: the worst cooperation) to express how they fell about the cooperation of patients undergoing the bronchoscopy.|After bronchoscopy|||||||
1419665|NCT01101477|Secondary|The Total Doses of Propofol During Induction and Overall Procedures|The dosses of propofol used during induction and overall flexible bronchoscopy will be recored from the screen of the TCI pump.|after bronchoscopy|||||||
1419666|NCT01101477|Secondary|The Recovery Time to Orientation|The recovery time to orientation was defined as the time between finishing bronchoscopy to the time when the patients could spontaneously open their eyes, recall their date of birth, and correctly perform finger-nose test.|after bronchosocpy|||||||
1419667|NCT01101477|Primary|The Number of Changes in Target Effect Site Concentration During Flexible Bronchoscopy|The investigator will titrate the target effect site concentration (Cet) during bronchoscopy according to protocol to keep stable vital signs and sedative levels. The numbers of adjustment will be recorded to show which regimen required less adjustment to keep stable sedative levels and vital signs.|During sedative induction and bronchoscopy|||||||
1419668|NCT01101477|Primary|The Number of Patients With Hypoxemia During Flexible Bronchoscopy|"Hypoxemia is defined as:~Oxyhemoglobin saturation (SPO2) is less than 90 % with any duration"|During sedative induction and bronchoscopy|The participants who received intervention completely were analyzed.|||participants|||Number
1419669|NCT01101464|Primary|Pharmacokinetic Parameter of Area Under the Curve (AUC) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of area under the curve (AUC) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).|||ng*h/mL||Standard Deviation|Mean
1419670|NCT01101464|Primary|Pharmacokinetic Parameter of Time of Occurrence of Cmax (Tmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of time of occurrence of Cmax (Tmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222.~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2"|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).|||Hours||Full Range|Mean
1419684|NCT01101165|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in period 2 was excluded from this PK analysis.|||ng*h/mL||Standard Deviation|Mean
1440824|NCT00928720|Secondary|General Sleep Disturbance Scale||Week 8||||units on a scale||Standard Deviation|Mean
1419671|NCT01101464|Primary|Pharmacokinetic Parameter of Maximum Plasma Concentration (Cmax) of Two Differing Tablet Strengths (3 x 5 mg and 1 x 15 mg) of Sublingually Administered Org 5222 (Asenapine)|"The primary objective is to compare the bioavailability using pharmacokinetic parameter of maximum plasma concentration (Cmax) of two differing tablet strengths (3 x 5 mg and 1 x 15 mg) of sublingually administered Org 5222~Measurements were performed after each cross-over period: Day 5 measurement for 3x5mg for participants from Sequence 1 and 1x15mg for participants from Sequence 2; Day 7 measurement for 1x15mg for participants from Sequence 1 and 3x5mg for participants from Sequence 2."|Day 5 & Day 7|All participants were included in both treatment comparisons (as per cross over design).|||ng/mL||Standard Deviation|Mean
1419672|NCT01101321|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1419673|NCT01101321|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1419674|NCT01101321|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1419675|NCT01101308|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419676|NCT01101308|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419677|NCT01101308|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
1419678|NCT01101191|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419679|NCT01101191|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419680|NCT01101191|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over a 72-hour period.|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
1419681|NCT01101178|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics; Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419682|NCT01101178|Primary|AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values.|Blood samples collected over 72-hour period|Full Analysis Population for pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419683|NCT01101178|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for Pharmacokinetic (PK) Metrics: Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
1419685|NCT01101165|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis. Note:One subject in Period 2 was excluded from this PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419686|NCT01101165|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
1419687|NCT01101035|Primary|Percentage of Participants With Primary MACE Composite (Final Analysis)|Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1419688|NCT01101035|Secondary|Percentage of Participants With Unstable Angina With Urgent Coronary Revascularization|Events were adjudicated by an independent cardiovascular endpoints committee as unstable angina with urgent coronary revascularization.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1419689|NCT01101035|Secondary|Percentage of Participants With Non-fatal Stroke|Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal stroke.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1419690|NCT01101035|Secondary|Percentage of Participants With Non-fatal Myocardial Infarction (MI)|Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal MI.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1419691|NCT01101035|Secondary|Percentage of Participants With Cardiovascular (CV) Death|Events were adjudicated by an independent cardiovascular endpoints committee as CV death.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1419692|NCT01101035|Secondary|Percentage of Participants With Antiplatelet Trialists' Collaborative (APTC) Event|APTC events were defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.|Up to last dose of study drug (approximately 83 months)|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1419693|NCT01101035|Primary|Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis)|Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.|Up to last dose of study drug (approximately 83 months)|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
1419694|NCT01101022|Secondary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks|AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1419695|NCT01101022|Secondary|Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
1419696|NCT01101022|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks|The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
1419697|NCT01101022|Secondary|Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks|"Question 1: 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). Higher scores representing a more positive rating.~Question 4: 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). Lower scores represent better quality of life."|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1419698|NCT01101022|Secondary|Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1419701|NCT01101022|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS|||Percent of participants|||Number
1419702|NCT01101022|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Lower scores indicate reduction in symptoms.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1419703|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
1419704|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks|BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
1419705|NCT01101022|Secondary|Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|FAS|||T-scores||Standard Error|Mean
1419706|NCT01101022|Secondary|Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to10 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
1419707|NCT01101022|Secondary|Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks|The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life.|Baseline and up to 10 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1419708|NCT01101022|Primary|Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and up to 10 weeks|Full Analysis Set (FAS) defined as all subjects who took 1 dose of investigational product in the double-blind evaluation phase and had 1 primary efficacy assessment.|||T-scores||Standard Error|Least Squares Mean
1419709|NCT01100944|Secondary|Relative Changes in T Cell Immunoglobulin Domain and Mucin Domain-3 (TIM3)-Expressing Cluster of Differentiation 8 (CD8)+Tcells|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.|||Relative fold change||Full Range|Median
1419710|NCT01100944|Secondary|Relative Changes in the Number of Tregs With Treatment|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Three samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.|||relative fold change||Full Range|Median
1419711|NCT01100944|Secondary|Relative Change Observed in Total Protein Hyperacetylation of Cluster of Differentiation 3 (CD3)+T Cells With Belinostat|Changes in marker levels from baseline. All pre values were set to 1 so that we could measure changes relative to the baseline.|Baseline Cycle 1 Day 1 (C1D1), Cycle 1 Day 2 (C1D2), Cycle 1 Day 3 (C1D3), and Cycle 2 Day 1 (C2D1)|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. Two samples could not be analyzed since they were of poor quality with too few cells for immune cell subset analysis or the samples could not be collected in time for pharmacodynamics analysis.|||Relative fold change||Full Range|Median
1419712|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF)/Dose|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||hr*ng/ml/mg||Standard Deviation|Mean
1419713|NCT01100944|Secondary|Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUC(INF))|AUC is a measure of the serum concentration of Belinostat over time. It is used to characterize drug absorption.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||hr*ng/ml||Standard Deviation|Mean
1419714|NCT01100944|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time to reach peak concentration after drug administration.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||Hour||Standard Deviation|Mean
1440976|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms.||2 years||||percentage of participants|||Number
1419715|NCT01100944|Secondary|Maximum Plasma Concentration (Cmax)/Dose|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||ng/ml/mg||Standard Deviation|Mean
1419716|NCT01100944|Secondary|Maximum Observed Plasma Concentration (Cmax) of Belinostat|Plasma concentrations of Belinostat were measured using a newly designed and validated ultra high-performance liquid chromatography (HPLC) with tandem mass spectrometric (MS/MS) assay, with a lower limit of quantification of 5ng/mL.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose|One patient was excluded from pharmacokinetic analysis due to insufficient sampling in dose level 2. Dose normalized parameters are normalized to absolute total dose (over 48 hours continuous intravenous infusion (CIVI)) for that patient, not dose level.|||ng/ml||Standard Deviation|Mean
1419717|NCT01100944|Secondary|Total Clearance (CL) of Belinostat|Clearance is the amount of time for the drug to be eliminated from the body.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose||||L/hr||Standard Deviation|Mean
1419718|NCT01100944|Secondary|Time to Half Life (t1/2) of Belinostat|Half life is the duration of time for the drug to be reduced to half the original amount.|on day 1: pre-belinostat and 0, 0.5, 1 and 2 hours after belinostat infusion, on day 3: 0, 0.8, 0.25, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-last belinostat dose.||||Hour||Standard Deviation|Mean
1419719|NCT01100944|Secondary|Overall Survival (OS)|Overall survival is defined as the on-study date until the date of death or progression as appropriate.|Start of treatment to time of death, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.|||months||Full Range|Median
1419720|NCT01100944|Secondary|Progression Free Survival (PFS)|Duration of time from start of treatment to time of progression or death whichever occurs first.|Start of treatment to time of disease progression or death whichever occurs first, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response.|||months||Full Range|Median
1419721|NCT01100944|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria (e.g. Response Evaluation Criteria in Solid Tumors (RECIST)) are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|From the time of first response until date of progression, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response|||months||95% Confidence Interval|Median
1419722|NCT01100944|Secondary|Time to Response|Time to response is the time between the first day of treatment until first date of response (complete response (CR) + partial response (PR)) (whichever is first recorded).|From the first day of treatment until the date of first documented response, assessed up to 43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||days||Full Range|Median
1419723|NCT01100944|Secondary|Disease Control Rate (DCR)|DCR is defined as stable disease (SD) + partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST).|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||percentage of participants||95% Confidence Interval|Number
1419724|NCT01100944|Secondary|Clinical Response|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||Participants|||Count of Participants
1419725|NCT01100944|Secondary|Treatment-related Grade 3 and 4 Adverse Events (Highest Grade Per Event Per Patient)|Here are the number of patients with treatment -related grade 3 and 4 adverse events (highest grade per event per patient).|up to 122 months||||Participants|||Count of Participants
1419726|NCT01100944|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of events, see the adverse event module.|up to 122 months||||Participants|||Count of Participants
1419727|NCT01100944|Primary|Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies|Objective response rate is the number of participants with a best objective response of partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST) divided by the number of participants who had treatment.|43 months|One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response.|||percentage of participants||95% Confidence Interval|Number
1419770|NCT01100437|Other Pre-specified|6-β-Naltrexone Plasma Concentration at First COWS ≥ 13 in Treatment Phase||Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|ITT; Subset of all participants with COWS ≥ 13|||pg/mL||Standard Deviation|Mean
1419728|NCT01100944|Primary|Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat|A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|up to 122 months||||Participants|||Count of Participants
1419729|NCT01100944|Primary|Maximum Tolerated Dose (MTD) of Belinostat|The MTD is defined as the highest dose at which less than 2 out of 6 patients experienced a dose limiting toxicity (DLT). A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours.|2 years||||mg/m(2)|||Number
1419730|NCT01100931|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|31.5 months||||Participants|||Number
1419731|NCT01100931|Primary|Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 18 weeks|Phase I is not included here because this outcome measure is for phase II only.|||Participants|||Number
1419732|NCT01100931|Primary|Phase 1 Safe and Tolerable Phase 2 Dose.|"Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).~Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1."|1 year|Phase I dose was variable dosing schedule to determine maximum tolerated dose (MTD) with 22 patients analyzed. Dose was variable with MTD at 10mg/m^2.|||mg/m^2|||Number
1419733|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines) Amphetamine||24 weeks||||Urine Drug Screen|||Number
1419734|NCT01100853|Secondary|Prior Admissions to Vogur Hospital|Number of prior admissions due to substance dependence. The term “prior admissions” refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.|Baseline||||Number of admissions||Standard Deviation|Mean
1419735|NCT01100853|Secondary|Risk Assessment Battery|The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.|24 weeks||||Total Score||Standard Deviation|Mean
1419736|NCT01100853|Secondary|Beck Depression Inventory|The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.|24 weeks||||BDI Score||Standard Deviation|Mean
1419737|NCT01100853|Secondary|Amphetamine Craving Scale|The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.|24 weeks||||VAS Score||Standard Deviation|Mean
1419738|NCT01100853|Primary|Number Negative Urines (Proportion Negative Urines)||24 Weeks|Urine drug screens negative amphetamine|||Urine Drug Screen|||Number
1419739|NCT01100762|Primary|First Step Velocity|First step velocity was measured in meters per second|Data collection occurred before and immediately after each training session||||m/sec||Standard Deviation|Mean
1419740|NCT01100762|Primary|First Step Length|First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.|Data collection occurred before and immediately after each training session||||m||Standard Deviation|Mean
1419741|NCT01100762|Primary|Number of Steps to Regain Balance|Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.|Data collection occurred before and immediately after each training session||||steps||Standard Deviation|Mean
1419742|NCT01100762|Primary|Cadence|Cadence was measured in steps per minute|Data collection occurred before and immediately after each training session||||steps/min||Standard Deviation|Mean
1419743|NCT01100762|Primary|Gait Velocity|Gait Velocity was measured in meters per second|Data collection occurred before and immediately after each training session||||m/s||Standard Deviation|Mean
1419744|NCT01100762|Primary|Stride Length|Stride Length was measured in centimeters|Data collection occurred before and immediately after each training session||||cm||Standard Deviation|Mean
1427917|NCT01027286|Secondary|Preoperative & Postoperative Hemoglobin Values||within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)||||g/dL||Standard Deviation|Mean
1419745|NCT01100723|Secondary|Percent of Patients on Cinacalcet and Vitamin D Analogues|Compare the percent of patients on cinacalcet and vitamin D analogues at baseline and at 6 and 12 months after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|6 months and 1 year|Number of subjects with at least 1 laboratory analysis during the evaluation period.|||percentage of subjects receiving med|||Number
1419746|NCT01100723|Secondary|Percent of Patients Achieving Calcium Target ≤ 10.1|Compare the percent of patients achieving a calcium ≤ 10.1 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects with at least one laboratory value during evaluation period.|||percentage of subjects in target|||Number
1419747|NCT01100723|Secondary|Percent of Patients Achieving Phosphorous Target ≤ 4.5|Compare the percent of patients achieving a phosphorus of ≤ 4.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year||||percent of participants in target|||Number
1419748|NCT01100723|Secondary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 450|Compare the percent of patients achieving an intact PTH target of ≤ 450 pg/ml before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year||||percent of participants in target|||Number
1419749|NCT01100723|Primary|Percent of Patients Achieving Phosphorous Target ≤ 5.5|Compare the percent of patients achieving a phosphorus of ≤ 5.5 mg/dL before and after the application of a computerized dosing protocol for management of CKD-MBD. If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year||||percent of participants in target|||Number
1419750|NCT01100723|Primary|Percent of Patients Achieving Parathyroid Hormone Target ≤ 300|Compare the percent of patients achieving an intact Parathyroid hormone (PTH) target of ≤ 300 pg/ml before and after the application of a computerized dosing protocol for management of chronic kidney disease-mineral and bone disorder (CKD-MBD). If multiple values were obtained within a specified evaluation time frame the values were averaged and the average value was then evaluated as to whether it was within or outside the target range.|1 year|Subjects who had at least one laboratory measurement during the assessment phase.|||percentage of subjects meeting target|||Number
1419751|NCT01100658|Secondary|Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior|Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function [BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form [CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores > or = 60 represent areas of significant behavior concern.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.||||||
1419752|NCT01100658|Primary|Effectiveness of Methylphenidate on Neurocognitive Components|Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.|Week 1 and Week 2|No patients received treatment, therefore analysis was not done.||||||
1419753|NCT01100606|Primary|Question 6 (Previous Pancreatic Enzyme Product [PEP])|"Acceptability questionnaire consists of 9 questions (Q) to assess the ease, time, overall satisfaction of study drug. Q6 included name of previous PEP administered. Q6 was reported as number of participants who used any PEP prior to screening."|Baseline|Safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
1419754|NCT01100606|Primary|Treatment Difference for Acceptability of Treatment|Acceptability questionnaire consists of 9 question (Q) to assess ease, time, overall satisfaction of study drug. Rated on 5-point scale for Q1-Q5 and Q7-Q9; Q6 was not rated and asked for name of previous PEP administered. Q1=overall ease of administration (1=not at all easy,2=somewhat,3=easy,4=very,5=extremely); Q2=time of administration (1=very short[<2 min],2=short[2-5 min],3=moderate[5-15 min],4=long[15-25 min],5=very long[>25 min]);Q3=overall infant acceptance(1=very easily,2=easily,3=same,4=with difficulty,5=with great difficulty);Q4=clear/complete instructions(1=not clear,2=somewhat,3=clear,4=very,5=extremely);Q5=overall satisfaction with dosing method (1=not satisfied,2=somewhat,3=satisfied,4=very,5=extremely);Q7=comparative ease of administration (1=much worse,2=worse,3=same,4=better,5=much better);Q8=comparative infant acceptance (1=much more difficult,2=more,3=same,4=easier,5=much easier);Q9=comparative overall satisfaction (1=much less,2=less,3=same,4=more,5=much more).|Baseline up to end of study (Day 21)|Intention-to-treat (ITT) population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of exocrine pancreatic insufficiency (EPI). Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||units on a scale||Full Range|Median
1419755|NCT01100606|Secondary|Number of Participants With Abnormal Findings With Respect to Oral Mucosa|Safety assessed by the presence of lesions observed during a physical examination at each visit. Severity of lesions measured by investigator's assessment using the following scale: mild = asymptomatic or mild symptoms and treatment not indicated; moderate = moderate pain but not interfering with oral intake, modified diet indicated; severe = severe pain, interfering with oral intake and life threatening or fatal.|Baseline up to end of study (Day 21)|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
1419756|NCT01100606|Secondary|Number of Participants With Abnormal Clinical Laboratory and Vital Signs Findings||Baseline up to end of study (Day 21)|Data was reported in individual participant listings but not statistically summarized for analysis as planned.||||||
1419757|NCT01100606|Secondary|Number of Abdominal Pain Symptoms|Symptoms of pain was classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of pain symptoms per day||Standard Deviation|Mean
1419758|NCT01100606|Secondary|Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of flatulence per day||Standard Deviation|Mean
1419759|NCT01100606|Secondary|Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as 0=none, 1=mild (no impairment of daily activities), 2=moderate (slight impairment of daily activities), and 3=severe (unable to perform daily activities). Average number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Average number of symptoms during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of bloating per day||Standard Deviation|Mean
1419760|NCT01100606|Secondary|Number of Stools With Signs of Blood and Visible Oil or Grease|Average number of stools with signs of blood and visible oil or grease of each participant was calculated from number of stools with signs of blood and visible oil or grease by the participant per day. Average number of stools with signs of blood and visible oil or grease during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of stools per day||Standard Deviation|Mean
1419761|NCT01100606|Secondary|Number of Stools Categorized as Per Consistency|Stool consistency was categorized as hard, formed/normal, soft and diarrhea. Average number of stools categorized as per consistency of each participant was calculated from number of stools of specific consistency by the participant per day. Average number of stools categorized as per consistency during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of stools per day||Standard Deviation|Mean
1419762|NCT01100606|Secondary|Daily Number of Stools|Average daily number of stools of each participant was calculated from frequency of stools by the participant per day. Average daily number of stools during the first treatment period, second treatment period and end of study for total participants was summarized.|Up to Day 10 in first and second treatment periods, end of study (Day 21)|ITT population included all participants who received at least 1 dose of study medication, had data (partial or complete) on acceptability questionnaire on and clinical signs and symptoms of EPI. Here, 'N' (number of participants analyzed) =participants who were evaluable for this measure.|||average number of stools per day||Standard Deviation|Mean
1419763|NCT01100567|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase||baseline to 5 days||||ug/L/day||95% Confidence Interval|Mean
1419764|NCT01100567|Primary|Change From Baseline in C-telopeptides||Baseline to 5 days||||ng/mL/day||95% Confidence Interval|Mean
1419765|NCT01100502|Secondary|Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin||Up to 12 months|ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)|||participants|||Number
1419766|NCT01100502|Secondary|Incidence of Adverse Events or Laboratory Abnormalities||Up to 12 months|Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis|||participants|||Number
1419767|NCT01100502|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause|Up to approximately 10 years||2021-04-30|04/2021||||
1419768|NCT01100502|Primary|Progression-free Survival by Independent Review|Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first|Up to approximately 4 years|Intention-to-Treat analysis set|||months||95% Confidence Interval|Median
1419769|NCT01100437|Other Pre-specified|Maximum Post-dose COWS in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Between 0.5 and 24 hours post-dose|ITT|||units on a scale||Standard Deviation|Mean
1419773|NCT01100437|Other Pre-specified|Time to First Occurrence of a COWS Score ≥ 13 for Each Treatment During the Treatment Phase|Average time to first occurrence of a COWS score ≥ 13|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hr post-dose and UA|ITT; Subset of participants with COWS >= 13|||h||Standard Error|Mean
1419774|NCT01100437|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Average AUC 0-∞ for Morphine, Naltrexone and 6-β-Naltrexol reported.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category|||ng*h/mL||Standard Deviation|Mean
1419775|NCT01100437|Secondary|Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase|Average AUC0-last for Morphine, Naltrexone and 6-β-Naltrexol. Area under the plasma concentration time-curve from time zero to the last measured concentration.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category|||ng*h/mL||Standard Deviation|Mean
1419776|NCT01100437|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase|Average AUC0-τ for Morphine, Naltrexone and 6-β-Naltrexol reported. τ=24 hours|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for the specific category|||ng times h divided by mL (ng*h/mL)||Standard Deviation|Mean
1419777|NCT01100437|Secondary|Plasma Decay Half-Life (t1/2) During the Treatment Phase|Average plasma decay half-life of morphine, naltrexone and 6-β-Naltrexol. Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category|||h||Standard Deviation|Mean
1419778|NCT01100437|Secondary|Volume of Distribution (Vd/F)During the Treatment Phase|Average Vd/F for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable date for the specific category|||liter (L)||Standard Deviation|Mean
1419779|NCT01100437|Secondary|Apparent Oral Clearance (CL/F) During the Treatment Phase|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; N=number of participants with evaluable data; n=number of participants with evaluable data for the specific category|||liters/hour (L/h)||Standard Deviation|Mean
1419780|NCT01100437|Secondary|Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase|Average Cmin for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category|||ng/mL||Standard Deviation|Mean
1419781|NCT01100437|Secondary|Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase|Average Cmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|PK population; n=number of participants with evaluable data for specific category|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1419782|NCT01100437|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase|Average Tmax for Morphine, Naltrexone and 6-β-Naltrexol|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose|Pharmacokinetic (PK) population: all randomized participants who received at least one dose of EMBEDA (whole or crushed) in the Treatment Phase and had at least one PK assessment completed in the Treatment Phase; n=number of participants with evaluable data for the specific category|||hours (h)||Standard Deviation|Mean
1419783|NCT01100437|Secondary|Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases|Average pain scores in the previous 24 hours using an 11 point NPRS ranging from no pain (0) to worst pain (10).|Baseline up to Day 63|ITT; N=number of participants with evaluable data; n=number of participants evaluated at the specific time point|||units on a scale||Standard Deviation|Mean
1419784|NCT01100437|Primary|Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase|COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).|Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA)|Intent-to-treat population (ITT): all randomized participants who received at least one dose of double-blind treatment in the Treatment Phase and had at least one post-dose pharmacodynamic assessment completed in the Treatment Phase.|||participants|||Number
1419785|NCT01100320|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis|||ng*h/mL||Standard Deviation|Mean
1419786|NCT01100320|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1427918|NCT01027286|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)||||participants|||Number
1419787|NCT01100320|Primary|Cmax - Maximum Observed Plasma Concentration|Bioequivalence based on Cmax|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
1419788|NCT01100307|Other Pre-specified|Change From Baseline in The 25-Item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 54: Open Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.~Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.~Positive change indicated improvement."|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Units on a scale||Standard Deviation|Mean
1419789|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 54: Open Phase|Retinal thickness was assessed by spectral-domain optical coherence tomography or OCT3000, a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419790|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419791|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419792|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Open Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.~Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 – 14 letters; Lost 1 - 9 Letters; No change or gained 1 – 9 letters; Gained 10 – 14 letters; Gained 15 letters or more."|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419793|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48, and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
1419794|NCT01100307|Other Pre-specified|Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Composite Score/Sub-scale Score at Week 24: Double Masked Phase|"NEI-VFQ 25, Japanese version v.1.4 for self-administering questionnaires consisted of the base set of 25 questions and 12 subscale scores.~Response categories to each question were converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. A higher score represented better functioning. Questions within each sub-scale were averaged together to create the 12 sub-scale scores. The overall composite score was calculated by averaging the vision-targeted subscale scores excluding the general health-rating question.~Positive change indicated improvement."|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Units on a scale||Standard Deviation|Mean
1419795|NCT01100307|Other Pre-specified|Number of Participants Exhibiting a Decrease From Baseline in Retinal Thickness at the Center Point by ≥25 Percent and ≥50 Percent Using Optical Coherence Tomography (OCT) at Week 24: Double Masked Phase|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo. The anatomic layers within the retina, retinal thickness could be measured.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419821|NCT01100073|Secondary|Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration|Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II and III scores available|||Points on a UPDRS scale||Standard Deviation|Mean
1419796|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥15, ≥5, or ≥0 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419797|NCT01100307|Other Pre-specified|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419798|NCT01100307|Other Pre-specified|Distribution of Change From Baseline of Visual Acuity (VA) at Each Time Point: Double Masked Phase|"Best-corrected VA measurements were performed using retro-illuminated, modified Ferris-Bailey ETDRS charts.~Change from baseline in VA was categorized as follows: Lost 15 letters or more; Lost 10 – 14 letters; Lost 1 - 9 Letters; No change or gained 1 – 9 letters; Gained 10 – 14 letters; Gained 15 letters or more."|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419799|NCT01100307|Other Pre-specified|Mean Visual Acuity Over Time at Each Time Point: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
1419800|NCT01100307|Secondary|Number of Participants Who Underwent Focal/Grid Laser, or Vitrectomy: Open Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Weeks 24 to 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419801|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Open Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline, Weeks 30, 36, 42, 48 and 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
1419802|NCT01100307|Secondary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 54: Open Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 54|Full Analysis Set 2: participants who received at least 1 injection and had VA assessments both at baseline and at least once at post-dose in open phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419803|NCT01100307|Secondary|Number of Participants Underwent Focal/Grid Laser, or Vitrectomy: Double Masked Phase|Included focal laser photocoagulation, grid laser photocoagulation, and vitrectomy.|Up to 24 weeks|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419804|NCT01100307|Secondary|Change From Baseline in Visual Acuity (VA): Double Masked Phase|Changes in VA were monitored through refraction and best-corrected VA measurements using retro-illuminated, modified Ferris-Bailey ETDRS charts|Baseline, Weeks 6, 12, 18, and 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Letters||Standard Deviation|Mean
1419805|NCT01100307|Primary|Number of Participants Who Experience a ≥10 Letter Improvement of Visual Acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) Chart From Baseline at Week 24: Double Masked Phase|Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.|Baseline and Week 24|Full Analysis Set 1: participants who received at least 1 injection after randomized to study treatment and had VA assessments both at baseline and at least once at post-dose in the double-masked phase. Missing values except for baseline value were imputed using a last observation carried forward approach (LOCF).|||Participants|||Number
1419806|NCT01100268|Secondary|Number of Patients Who Met Response Criteria for the Saving Inventory-Revised.|Patients given Saving Inventory-Revised (SI-R), an evidence-based measure of three features of hoarding: excessive acquisition, difficulty discarding, and clutter. For the SI-R the minimum units are 0 and Maximum units on the total scale are 92. The higher the number on the SI-R, the more severe the symptoms. Response was defined as at least a 25% reduction on the SI-R.|4 weeks||||participants|||Number
1419840|NCT01099761|Secondary|Change in Pulmonary Function Test (MEP)|Maximum Expiratory Pressure (MEP); 3 of 3 separate tests employed to assess pulmonary function in this study|Baseline to End-of-Stuidy Visit, approximately 24 weeks||||cm H2O||Standard Deviation|Mean
1419807|NCT01100268|Primary|Number of Patients Who Met and Exceeded Response Criteria of Attention Deficit Hyperactivity Disorder Symptom Scale|Patients given Attention Deficit Hyperactivity Disorder Symptom Scale (ADHDSS), a measure of the features of Attention Deficit Hyperactivity Disorder including inattention, hyperactivity, and impulsivity. This scale has shown excellent reliability in prior studies of individuals with HD. For the ADHDSS the minimum units are 0 and Maximum units on the total scale are 54 (adult). The higher the number on the ADHDSS, the more severe the symptoms. Response was defined as at least a 30% reduction on the ADHDSS.|4 weeks||||participants|||Number
1419808|NCT01100255|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|1 week||||participants|||Number
1419809|NCT01100242|Secondary|Toxicity Profile|Toxicity is assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Toxicity profile is reported as the number of patients who received at least one dose of on-study treatment and experienced a grade 3 or grade 4 adverse event (AE). For a more complete listing of all AEs experienced by patients on study, please see the Adverse Event section.|42 days||||participants|||Number
1419810|NCT01100242|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the percentage of patients who achieve a CR or PR|42 days||||percentage of participants|||Number
1419811|NCT01100242|Primary|Progression Free Survival (PFS)|Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 weeks||||weeks||Full Range|Median
1419812|NCT01100112|Secondary|Endoscopic Improvement|"Greater or equal to a 1 point improvement in the mucosal appearance subscore of the ulcerative colitis disease activity index (UCDAI), from baseline to week 8.~The UCDAI mucosal appearance subscore is graded as follows: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|8 weeks|All patients who received at least one dose of study drug.|||percentage of patients|||Number
1419813|NCT01100112|Secondary|Safety Evaluations: the Numbers of Patients Who Experience Serious Adverse Events (SAEs) or Other Nonserious Adverse Events (AEs) During the Course of the Study.|Safety will be assessed by evaluating SAEs and AEs. The outcome measure data are the numbers of patients who experienced SAEs or other nonserious AEs.|Throughout the 8 week treatment period|All patients who received at least 1 dose of study drug.|||participants|||Number
1419814|NCT01100112|Secondary|The Secondary Efficacy Endpoint is Clinical Improvement|The secondary efficacy endpoint is clinical improvement, defined as a drop in the Ulcerative Colitis Disease Activity Index score of > or = 3 points from baseline.|After 8 weeks treatment period|All patients who received at least 1 dose of study drug.|||percentage of patients|||Number
1419815|NCT01100112|Primary|The Percentage of Patients Achieving Clinical Remission|"The primary efficacy endpoint is clinical remission at 8 weeks, defined as a Ulcerative Colitis Disease Activity Index score of < or = 1 with a score of 0 for both rectal bleeding and stool frequency, and > or = 1 point reduction from baseline in endoscopy score, without any sign of mucosal friability (a score of 0 for mucosal appearance).~The UCDAI has 4 components. Each component is scored on scale of 0 to 3 (total maximum [worst] score = 12). Definitions of component scores are as follows: stool frequency: 0 = normal frequency, 1 = 1 - 2 stools per day greater than normal frequency, 2 = 3 - 4 stools per day greater than normal frequency, and 3 = > 4 stools per day greater than normal frequency; rectal bleeding: 0 = none, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood; physician's rating of disease activity: 0 = normal, 1 = mild, 2 = moderate, 3 = severe; mucosal appearance: 0 = normal, 1 = mild friability, 2 = moderate friability, 3 = exudation, spontaneous bleeding."|At the end of the 8 week treatment period|All patients who received at least 1 dose of study drug.|||percentage of patients|||Number
1419816|NCT01100086|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419817|NCT01100086|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419818|NCT01100086|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
1419819|NCT01100073|Secondary|Number of Premature Discontinuations|Number of patients discontinuing the study prematurely|Week 0 to weeks 9-16 (end of study)|Total patients|||Participants|||Number
1419820|NCT01100073|Secondary|Incidence, Relationship and Seriousness of Adverse Events|Total number of adverse events (AEs), causality and level of seriousness|Week 0 to weeks 9-16 (end of study)|Total patients|||Number of events|||Number
1419822|NCT01100073|Secondary|Change From Baseline in UPDRS Part III Score at the End of Up-titration|Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part III scores available|||Points on a UPDRS scale||Standard Deviation|Mean
1419823|NCT01100073|Secondary|Change From Baseline in UPDRS Part II Score at the End of Up-titration|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Enter Week 0 to weeks 1-8 (Visit 2)|Patients for whom baseline and Visit 2 UPDRS Part II scores available|||Points on a UPDRS scale||Standard Deviation|Mean
1419824|NCT01100073|Secondary|Final Dose Distribution|Final Mirapexin® dose distribution at the end of study|Enter Week 0 to weeks 9-16 (Visit 3)|Total patients. Number of participants analysed differs for each outcome measure because not all evaluations were performed / documented on every patient.|||milligrams of Mirapexin® (salt)||Full Range|Median
1419825|NCT01100073|Primary|Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance|Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study PDQ-39 score available|||unit on a scale||Standard Deviation|Mean
1419826|NCT01100073|Primary|Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)|Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS tremor score (UPDRS items 16, 20, 21) available|||Points on UPDRS scale||Standard Deviation|Mean
1419827|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the left hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available|||millimeters of tremor amplitude||Standard Deviation|Mean
1419828|NCT01100073|Primary|Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)|Change (reduction) in tremor amplitude from baseline to end of study for the right hand|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available|||millimeters of tremor amplitude||Standard Deviation|Mean
1419829|NCT01100073|Primary|Change From Baseline in UPDRS Part III Score at the End of Maintenance|Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)|Week 0 to weeks 9-16|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available|||Points on UPDRS scale||Standard Deviation|Mean
1419830|NCT01100073|Primary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance|Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)|Week 0 to weeks 9-16 (Visit 3)|Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available|||Points on UPDRS scale||Standard Deviation|Mean
1419831|NCT01099969|Secondary|Cormack and Lehane Grade of Laryngeal View|The Comarck Lehane classification is as follows: 1)Full view of glottis; 2a) Partial view of glottis; 2b) Only posterior extremity of glottis seen or only arytenoid cartilages; 3) only epiglottis is seen, none of glottis seen; 4) neither glottis nor epiglottis seen.|at the time of intubation||||Participants|||Count of Participants
1419832|NCT01099969|Primary|Number of Difficult Intubations|"Ease of intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = extremely difficult). A score of 4 or 5 was characterized as difficult."|at the time of placement of the endotracheal tube||||intubations|||Number
1419833|NCT01099969|Primary|Number of Intubation Attempts||at the time of placement of the endotracheal tube||||Participants|||Count of Participants
1419834|NCT01099969|Primary|Intubation Time|Intubation time is the time from insertion of the laryngoscope to detection of CO2 on the capnogram.|time from insertion of the laryngoscope to detection of CO2 on the capnogram||||seconds||Standard Deviation|Mean
1419835|NCT01099917|Primary|Changes in Neutrophil Counts|The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients|baseline and week 12||||cells/mm^3||95% Confidence Interval|Mean
1419836|NCT01099774|Primary|Average Eye IOP at Week 2|Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 2|Intent to Treat Population: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1419837|NCT01099774|Primary|Average Eye IOP at Week 6|Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.|Week 6|Intent to Treat Population: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1419838|NCT01099774|Primary|Average Eye IOP at Week 12|Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.|Baseline, Week 12|Intent to Treat Population: all randomized patients.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1419839|NCT01099774|Primary|Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12|Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.|Baseline, Week 12|Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1419844|NCT01099761|Secondary|Change in Distance Traveled in 6 Minutes (Standardized 6-Minute-Walk Test).|Change in distance traveled in 6 minutes (standardized 6-Minute-Walk Test); stratified by baseline age (<10 years vs. >=10 years)|Baseline to End-of-Study Visit, approximately 24 weeks later.||||change (m) in 6MWT from baseline||Standard Deviation|Mean
1419845|NCT01099761|Secondary|Percent Change in Muscle Strength Score by Hand-held Myometry.|Manual Muscle Testing (MMT) is a procedure to measure the function and strength of individual muscles and muscle groups. Hand-held myometry, using a device known as a dynamometer, is one method used for MMT. The dynamometer is held against the patient's limb by the examiner and the patient is asked to resist the force applied by the examiner. The dynamometer measures the force applied by the patient, providing a quantitative and objective assessment of strength of the particular muscle or muscle group. The effectiveness of a therapeutic intervention on muscle strength, as measured by hand-held myometry, can be assessed by comparing post-treatment to pre-treatment (baseline) measurements.|Baseline to End-of-Study Visit, approximately 24 weeks later.||||percentage change from baseline||Standard Deviation|Mean
1419846|NCT01099761|Secondary|Percent Change in Lumbar Spine Bone Mineral Density by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.||||percentage change from baseline||Standard Error|Mean
1419847|NCT01099761|Secondary|Percent Change in Total Lean Body Mass by DXA Scan.||Baseline to End-of-Study Visit, approximately 24 weeks later.||||percentage change in lean body mass||Standard Error|Mean
1419848|NCT01099761|Primary|Number of Subjects With Clinical Laboratory Adverse Reactions.|Number of subjects in each cohort with treatment-emergent adverse laboratory values judged to be at least possibly related to study drug|Baseline to End-of-Study Visit, approximately 24 weeks later.||||Number of subjects|||Number
1419849|NCT01099761|Primary|Number of Subjects With Adverse Reactions.|Number of subjects in each cohort with a treatment-emergent adverse event considered at least possibly related to study drug|From treatment initiation to End-of-Study Visit, approximately 24 weeks later||||Number of subjects|||Number
1419850|NCT01099709|Primary|AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419851|NCT01099709|Primary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over a 72-hour time period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng*h/mL||Standard Deviation|Mean
1419852|NCT01099709|Primary|Cmax - Maximum Observed Plasma Concentration|Bioeqivalence based on Cmax.|Blood samples collected over 72-hour period|Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis. Subjects who experienced emesis within 12 hours after dosing were excluded from PK analysis.|||ng/mL||Standard Deviation|Mean
1419853|NCT01099618|Primary|Length of Remission|For those patients that are able to discontinue insulin therapy at or <12 weeks, how long were they able to well controlled with an A1c <7% on the agent that they were randomized to.|3 years||||days||Full Range|Median
1419854|NCT01099579|Secondary|Apparent Total Body Clearance Per Body Weight (CLT/F) Per Kilogram of Atazanavir and Ritonavir|Calculated as CLT/F divided by body weight|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||L/h per kilogram||Full Range|Geometric Mean
1419855|NCT01099579|Secondary|Apparent Total Body Clearance (CLT/F) of Atazanavir and Ritonavir|Calculated as dose divided by AUC(TAU). AUC(TAU)=area under the concentration-time curve in 1 dosing interval from time 0 to 24 hours post observed dose.|At Week 2|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||L/h||Full Range|Geometric Mean
1419856|NCT01099579|Secondary|Time to Maximum Observed Concentration (Tmax) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||Hours||Full Range|Median
1419857|NCT01099579|Secondary|Area Under the Concentration Curve (in 1 Dosing Interval From Time 0 to 24 Hours Post Observed Dose) (AUC[TAU])of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||ng*h/mL||Full Range|Geometric Mean
1419858|NCT01099579|Secondary|Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of Atazanavir and Ritonavir||At Week 2 at Hour 0 predose and at Hours 1.5, 2.5, 4, 6, 8, 12, and 24 postdose|All participants who had received study drug and had adequate pharmacokinetic profiles (n=number evaluable)|||ng/mL||Full Range|Geometric Mean
1419859|NCT01099579|Secondary|Number of Participants Who Acquired Phenotypic Resistance to Atazanavir or Atazanovir/Ritonavir|Criteria for resistance testing= meeting at least 1 of the following: <1 log10 drop from baseline in HIV RNA level by Week 16 and confirmed by a second HIV RNA level; an HIV RNA level >200 copies/mL after Week 24, confirmed by a second HIV RNA level; repeated HIV RNA levels ≥50 copies/mL after Week 48; an HIV RNA level ≥400 copies/mL confirmed by a second HIV RNA level of ≥400 copies/mL at any time in a participant who had previously achieved a plasma HIV RNA level <50 copies/mL; or discontinued due to lack of efficacy. Virologic failure was defined as an incomplete virologic response to therapy or as a viral rebound after the achievement of virologic suppression. The phenotypic resistance to a drug is defined as a fold change (ie, ratio of the 50% inhibitory concentration [IC50] of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility.|After Day 1 to Week 48|Participants who met the criteria for virologic failure|||Participants|||Number
1419860|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder|||Percentage of lymphocytes||Standard Error|Mean
1419861|NCT01099579|Secondary|Mean CD4 Percent Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 percent at baseline and Week 48 while taking ATV powder|||Percentage of lymphocytes||Standard Error|Mean
1419862|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder|||Cells/mm^3||Standard Error|Mean
1419863|NCT01099579|Primary|Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events|CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.|From Day 1 to Week 48||||Participants|||Number
1419864|NCT01099579|Primary|Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48|Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.|From Baseline to Week 48|All participants who received at least 1 dose of atazanavir and were evaluable|||Milliseconds||Standard Deviation|Mean
1419865|NCT01099579|Primary|Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4|ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6–5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.|After Day 1 to Week 48|All participants who received at least 1 dose of atazanavir; n=number of evaluable participants.|||Participants|||Number
1419866|NCT01099579|Secondary|CD4 Cell Count Changes From Baseline at Week 48 by Treatment/Weight||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had CD4 at baseline and Week 48 while taking ATV powder|||Cells/mm^3||Standard Error|Mean
1419867|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Prior Antiretroviral (ARV) Treatment Status||From Baseline to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who had an HIV RNA measurement on ATV powder at Week 48|||Log10 c/mL||Standard Error|Mean
1419868|NCT01099579|Secondary|Mean Change From Baseline in HIV RNA Levels at Week 48 by Treatment/Weight|Participants who received at least 1 dose of atazanavir (ATV) and had an HIV RNA measurement on ATV powder at did not switch to the capsule formulation before Week 48|From Baseline to Week 48|Participants who received at least 1 dose of atazanavir and who had HIV RNA while taking atazanavir powder at Week 48|||Log10 c/mL||Standard Error|Mean
1419869|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Prior Antiretroviral (ARV) Treatment Status|The definition of virologic success included HIV RNA levels <50 c/mL or <400 c/mL at the Week 48 analysis.|From Day 1 to Week 48|Participants who received at least 1 dose of atazanavir (ATV) and who did not switch to the ATV capsule formulation on or before Week 48|||Percentage of participants|||Number
1419870|NCT01099579|Secondary|Percentage of Participants With HIV RNA Levels <50 c/mL and <400 c/mL at Week 48 by Treatment/Weight|The definition of virologic success included HIV RNA levels <50 c/mL or 400 c/mL at the Week 48 analysis window. .|At Week 48|Participants who received at least 1 dose of atazanavir and who did not switch to the capsule formulation at or before Week 48|||Percentage of participants|||Number
1419871|NCT01099579|Primary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 to Week 48|All participants who received at least 1 dose of active atazanavir powder.|||Participants|||Number
1419872|NCT01099475|Secondary|Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by ALAT level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3.|ALAT area under curve from start of surgery up until postoperative day 3||||IU*h/L||Standard Error|Mean
1419873|NCT01099475|Secondary|Amount of Blood Loss|amount of blood in the suction container (and, if applicable, in the weighted gauzes)|at the end of liver surgery, an average of 225 minutes||||mL||Full Range|Median
1419886|NCT01099267|Primary|Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up|Count of participants who progressed to AML at the time of the extension study follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.|||participants|||Number
1427919|NCT01027286|Secondary|Total Calculated Hospital Blood Loss||daily during hospital stay (an expected average of 4 days)||||mL||Standard Deviation|Mean
1419874|NCT01099475|Secondary|Post-resectional Complications|morbidity and mortality occuring after liver surgery graded according to Clavien-Dindo's grading system. In short, any deviation from the postoperative course without the need for pharmacological, radiological or surgical intervention was classified as Clavien-Dindo grade 1; complications requiring pharmacological treatment were graded as grade 2; complications requiring surgical or radiological intervention not under general anesthesia as grade 3a and under general anesthesia as grade 3b; grade 4 complications were life-threatening complications requiring intensive care unit care because of single organ dysfunction (grade 4a) or multiple organ dysfunction (grade 4b); mortality was classed as grade 5.|within 90-days after initial liver surgery||||participants|||Number
1419875|NCT01099475|Primary|Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels|At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by L-FABP) level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3. This continuous variable with repeated measurements was summarized as area under the curve (AUC) from baseline to postoperative day 3 (as described in Matthews JN, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. Bmj 1990;300:230-5).|L-FABP area under curve from start of surgery up until postoperative day 3||||ng*h/mL||Standard Error|Mean
1419876|NCT01099397|Primary|Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment|A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.|Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)|Only including participants with data at each time point|||participants|||Number
1419877|NCT01099358|Primary|Cetuximab Pharmacokinetics: Confirmatory Serum Concentration||Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion.|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1419878|NCT01099358|Primary|Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.|||Hours (h)||Full Range|Median
1419879|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.|||Hours (h)||Full Range|Median
1419880|NCT01099358|Primary|Cetuximab Pharmacokinetics: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1419881|NCT01099358|Primary|Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.|||micrograms/milliliters(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1419882|NCT01099358|Primary|Cetuximab Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).|All participants who received at least one dose of study drug who were enrolled in Group B or C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D.|||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1419883|NCT01099358|Primary|Total Cisplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).|All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D.|||micrograms*hour/milliliters (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1419884|NCT01099267|Primary|Cause of Death for Participants Who Died|Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.|up to 7 years|Safety population of participants who died|||participants|||Number
1419885|NCT01099267|Primary|Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)|Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population. One participant was diagnosed by central reviewer as having AML at entry to the MDS-003 study (baseline) so was excluded from this analysis.|||months||95% Confidence Interval|Median
1419902|NCT01099215|Secondary|Incidence of Serious Adverse Events||Up to 48 weeks from study procedure|Intention-to-Treat Population Analysis|||participants|||Number
1419887|NCT01099267|Primary|Kaplan Meier Estimate for Overall Survival|Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up.|up to 7 years|Intent to treat population|||months||95% Confidence Interval|Median
1419888|NCT01099267|Primary|Participants Survival Status as of the Time of the Extension Study Follow-up|Count of participants who were alive or deceased at the time of the extension study follow-up.|up to 7 years|Intent to treat population|||participants|||Number
1419889|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 48 weeks|Intention-to-Treat Population Analysis|||participants|||Number
1419890|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 24 weeks|Intention-to-Treat Population Analysis|||participants|||Number
1419891|NCT01099215|Secondary|The Fontaine Class of Peripheral Artery Disease|CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate –severe claudication III Ischemic rest pain IV Ulceration or gangrene|change from baseline to 4 weeks|Intention-to-Treat Population Analysis|||participants|||Number
1419892|NCT01099215|Secondary|Changes in Physical Exam|Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported|within 4, 24 and 48 weeks from baseline|Safety Population Analysis|||participants|||Number
1419893|NCT01099215|Secondary|Resting Ankle-brachial Index|ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD.|within 4, 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis|||ratio||Standard Deviation|Mean
1419894|NCT01099215|Secondary|Number of Patients Requiring Reintervention of Target Lesion / Target Vessel|Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel|up to 48 Weeks from study procedure|Intention-to-Treat Population Analysis|||participants|||Number
1419895|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
1419896|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
1419897|NCT01099215|Secondary|Rate of Binary In-stent Restenosis|"Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0–49% being No (peak systolic velocity [PSV] ratio ≤2.4) and Yes being 50–99% (PSV ratio >2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis.~Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject."|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
1419898|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 48 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
1419899|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 24 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
1419900|NCT01099215|Secondary|Maintenance of Primary Patency of Superficial Femoral Artery (SFA)|Primary patency was defined as duplex ultrasound peak systolic velocity [PSV] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.|within 4 weeks from study procedure|Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)|||participants|||Number
1419901|NCT01099215|Secondary|Incidence of Adverse Events, Laboratory Abnormalities||Up to 48 weeks from study procedure|Safety Population Analysis|||participants|||Number
1419903|NCT01099215|Secondary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:~Death~Major amputation~Procedural related serious adverse events~Investigational product related serious adverse events"|within 24 and 48 weeks from study procedure|Intention-to-Treat Population Analysis|||participants|||Number
1419904|NCT01099215|Primary|Incidence of Major Adverse Events (MAEs)|"Major Adverse Events are:~Death~Major amputation~Procedural related serious adverse events~Investigational product related serious adverse events"|within 4 weeks after study procedure|Intention-to-Treat Population Analysis|||participants|||Number
1419905|NCT01099202|Primary|Number of PRBC Transfusions During Initial 5 Months of Treatment|Total number of all packed red blood cells (PRBCs) transfusions (events) given to a participant throughout the 6 courses of chemotherapy treatment, collected and reported by participant from fifth week beginning baseline to 5 months.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.|||transfusions||Standard Deviation|Mean
1419906|NCT01099202|Primary|Mean Number of RBC Units Transfused During Initial 5 Months of Treatment|Total number of packed red blood cell (PRBCs) units transfused to participant beginning at fifth week, up until 5-months compared between the evaluable study group subsets.|5 weeks to 5 Months|Transfusion data was available in 79 of the 81 (98%) evaluable patients who completed the treatment/observation period.|||PRBC Units||Standard Deviation|Mean
1419907|NCT01099111|Primary|Colonic-Mucosa Associated Microbial Species Per Compiled Participants in 5 Different Arms|"The entire mucosal microbial community were profiled using high-throughput DNA sequencing and microarray technology. The microarray approach is based on 16S rRNA gene targeted oligonucleotide allowing the rapid detection of thousands of DNA sequences simultaneously and thus constitutes an ideal tool to generate a comprehensive and holistic view of the gut microbial community in all participants of all study arms.~Then they will be analysed between different colonic segments in each participant, pooled results of participants in each of the 5 arms will be compared to the measurable outcomes of other arms in general."|1 - 2 weeks|Each participant colonic mucosal microbiota populations pattern were analysed, and then compared to control to look for specific enrichments. If the DNA extract was not enough for sequencing, then the participant sample was excluded, however analysis calculation was based on all enrolled participants. The number analyzed here represent all enrolled|||microbial species population||95% Confidence Interval|Number
1419908|NCT01098851|Primary|Number of Participants Requiring Airway Support|Drugs during surgery may cause the throat to relax and block breathing. To treat this, the caregiver administers airway support. Airway support is moving the jaw forward, inserting a plastic tube (nasal-oral airway) or applying a mask with positive pressure.|3 hours||||Participants|||Number
1419909|NCT01098851|Primary|Number of Participants With Saturation Pattern Detection (SPD) Indicative of Repetitive Reductions in Air Flow|Saturation Pattern Detection (SPD) is the pattern of oxygen saturation values plotted against time that occurs when patients have cyclical reduced air movement during breathing. Their blood oxygen level decreases and increases as they slow and increase their breathing.|3 hours||||Participants|||Number
1419910|NCT01098812|Secondary|Uncorrected Distance Visual Acuity (UCDVA)|Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant|Available subjects at the final visit with measured uncorrected distance visual acuity.|||LogMAR acuity values||Standard Deviation|Mean
1419911|NCT01098812|Primary|Mean Percent Reduction in Cylinder|Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean.|6 months after second eye implant compared to baseline|Subjects at the final visit with preoperative keratometric cylinder, intended/target cylinder and postoperative refractive cylinder.|||percentage of reduction in cylinder||Standard Deviation|Mean
1419912|NCT01098747|Secondary|Participant Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419913|NCT01098747|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
1419914|NCT01098747|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
1419915|NCT01098747|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Hours||95% Confidence Interval|Median
1419916|NCT01098747|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
1419917|NCT01098747|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
1419918|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419919|NCT01098747|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419920|NCT01098747|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0-2, 0-3, 0-6, 0-8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419921|NCT01098747|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419922|NCT01098747|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419923|NCT01098747|Secondary|Pain Relief Rating (PRR)|PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419924|NCT01098747|Secondary|Time to Confirmed First Perceptible Relief|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
1419925|NCT01098747|Primary|Time to Onset of Meaningful Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
1419926|NCT01098747|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)|SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 8 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1419927|NCT01098578|Other Pre-specified|Total Institutional Cost Savings|Difference between the total institutional cost of successfully treating 20 study patients with Floseal compared to the total institutional cost of treating the same number of patient with endoscopic surgery|End of study. Cost calculated after 20 patients were treated with Floseal||||US Dollars|||Number
1427920|NCT01027273|Secondary|Access to Medical Care|Number of participants who have a primary care doctor|6 months post enrollment into trial|1 missing response from Usual Care group|||participants|||Number
1419928|NCT01098578|Secondary|Cost Savings of Floseal Treatment in Comparison to Posterior Packing, Surgical, and Embolisation Treatments for Posterior Epistaxis.|The institutional cost for the treatment of posterior epistaxis patients with posterior packing, endoscopic surgery, and endovascular embolization, at TOH were calculated and compared with the institutional cost of a patient visit for posterior epistaxis successfully treated with the study protocol using Floseal. All costs were calculated in Canadian dollars (CAD), they were converted to US dollars (USD) using the current monetary exchange rate (total CAD x 1.03= total USD). For all of the patients treated in this study, the total institution cost was $24487.53 (USD). The minimal institutional cost of successfully treating all of the study patients with endoscopic surgery, would have been $53933.89 (USD) or 2.2 times the actual expense. (Total cost 20 participants Floseal/expected total cost 20 endoscopic surgery*100)This represents savings of $29446.39 (USD) or 45.40%|30 days||||percentage of expected cost|||Number
1419929|NCT01098578|Primary|Effectiveness of Floseal for the Treatment of Posterior Epistaxis.|Successful treatment using the gelatin-thrombin matrix protocol (Floseal) was any case of posterior epistaxis that stopped following the immediate application of either one or two syringes of Floseal® and the epistaxis did not resume within fourteen days of the treatment date.|Immediate effect with 1 hour observation and follow-up at 5 and 30 days following treatment.||||participants|||Number
1419930|NCT01098539|Secondary|Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16|Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.|Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)|ITT population. Only participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1419931|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 52: OC|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Kilograms||Standard Deviation|Mean
1419932|NCT01098539|Secondary|Change From Baseline in Body Weight Through Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.|Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Kilograms||Standard Deviation|Mean
1419933|NCT01098539|Secondary|Change From Baseline in Body Weight at Week 26: LOCF|Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
1419934|NCT01098539|Secondary|Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|Week 2 to Week 52|ITT Population|||Weeks||95% Confidence Interval|Median
1419935|NCT01098539|Secondary|Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52|Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.|Week 2 to Week 52|ITT Population|||Participants|||Number
1419936|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
1419937|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC|The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 52|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
1419938|NCT01098539|Secondary|Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF|The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
1419939|NCT01098539|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF|The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
1419940|NCT01098539|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1419941|NCT01098539|Secondary|Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, and 26|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1419942|NCT01098539|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.|Baseline; Week 26|ITT Population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1419943|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1430674|NCT01004393|Primary|Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone||4 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
1419944|NCT01098539|Secondary|Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.|Baseline; Weeks 4, 8, 12, 16, and 20|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1419945|NCT01098539|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 26|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants available at the indicated time point were assessed.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1419946|NCT01098500|Secondary|Median Time to the Maximum BIL Elevation During Follow-up|Median time (in months) between index date and date of maximum BIL elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.|||months||Full Range|Median
1419947|NCT01098500|Secondary|Maximum BIL Elevation Reached During Follow-up|Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident BIL elevation during follow-up.|||participants|||Number
1419948|NCT01098500|Secondary|Median Time to the Maximum ALP Elevation During Follow-up|Median time (in months) between index date and date of maximum ALP elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.|||months||Full Range|Median
1419949|NCT01098500|Secondary|Maximum ALP Elevation Reached During Follow-up|Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALP elevation during follow-up.|||participants|||Number
1419950|NCT01098500|Secondary|Median Time to the Maximum AST Elevation During Follow-up|Median time (in months) between index date and date of maximum AST elevation|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.|||months||Full Range|Median
1419951|NCT01098500|Secondary|Maximum AST Elevation Reached During Follow-up|Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident AST elevation during follow-up.|||participants|||Number
1419952|NCT01098500|Secondary|Median Time to the Maximum ALT Elevation During Follow-up|Median time (in months) between index date and the date of maximum ALT elevation.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.|||months||Full Range|Median
1419953|NCT01098500|Secondary|Maximum ALT Elevation Reached During Follow-up|Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had at least one incident ALT elevation during follow-up.|||participants|||Number
1419954|NCT01098500|Primary|Incidence of Hy’s Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)|Number of patients with Hy’s Law (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT, AST, ALP, and BIL (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug).|||participants|||Number
1419955|NCT01098500|Primary|Number of Hy’s Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)|Prevalence of patients with Hy’s Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug).|||participants|||Number
1420605|NCT01092910|Secondary|PTA Improvement|Comparison of the 3-frequency (500, 1000, and 2000 Hz) pure-tone average (PTA) using the Esteem System to the PTA measured in the baseline unaided condition|4 and 10 Months Post-Activation|10 month data reported|||dB improvement||Standard Error|Mean
1419956|NCT01098500|Primary|Incidence of ALT >=3x ULN|Number of patients with ALT >=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT <1 times ULN at baseline.|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had normal ALT (<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug)|||participants|||Number
1419957|NCT01098500|Primary|Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)|Prevalence of patients with an ALT elevation >=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).|Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.|Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug.|||participants|||Number
1419958|NCT01098487|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy|On-therapy + 1 day is defined as AEs started between the first dose of eltrombopag and up to the day after the last dose of eltrombopag; >1 to 30 days post therapy is defined as AEs that started more than 1 day and up to 30 days after the last dose of eltrombopag; >30 days post therapy is defined as AEs started that started more than 30 days after the last dose of eltrombopag. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population|||Participants|||Number
1419959|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study|Hematology parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: hemoglobin (increased), hemoglobin (anemia), lymphocyte count (increased), lymphocyte count (decreased), total absolute neutrophil count (ANC), platelet count and white blood cell (WBC) count. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population|||Participants|||Number
1419960|NCT01098487|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), sodium (hyponatremia), inorganic phosphorus and creatinine. Baseline values were obtained at Day 1. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during.|From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years)|ATS Population|||Participants|||Number
1419961|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 2 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
1419962|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at 1 Year|The change from Baseline to on-treatment assessments of collagen level was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period.|1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
1419963|NCT01098487|Primary|Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 2 years|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
1419980|NCT01098318|Secondary|The Clinical Global Impression (CGI) Severity and Change|"A clinician-rated measure of global symptom severity (CGI/S) and symptom change (CGI/C) of MDD. Severity was rated as Not ill; Borderline ill; Mild; Moderate; Moderately severe; Severe and Extremely severe. Global change was rates as Very much improved; Much improved; Minimally improved; Unchanged;Minimally worse;Much worse and Very much worse. Here in severity, we reported the N(%) of subjects who were not ill or borderline ill. In change, we reported N(%) of subjects who were Very much improved or Much imp[roved.Subjects started the study with mild to moderate MDD (moderate or above rating in the CGI-S). At WK12, the #/% of subjects in each treatment group who were not ill at WK12 (CGI-S) and who had much improved or very much improved at WK12 (CGI-C) was reported."|12 weeks||||Participants|||Count of Participants
1430675|NCT01004354|Secondary|Leptin at Baseline and Post-treatment||Baseline and 8 weeks||||ng/mL||Standard Deviation|Mean
1419964|NCT01098487|Primary|Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year|The change from baseline to on-treatment assessments of European Consensus (EC) scale was analyzed. On-treatment is defined as during the treatment period (including dose interruptions) and up to 14 days after the end of the treatment period. MF-0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF-1 is loose network of reticulin with many intersections, especially in perivascular areas; MF-2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline and 1 year|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
1419965|NCT01098487|Primary|Number of Participants With a Positive or Negative Collagen Level at Baseline|The number of participants with a positive or negative collagen level was analyzed. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|ATS Population. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
1419966|NCT01098487|Primary|Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline|The evaluation of fibrosis was performed using BM biopsies in which the amount of fibrosis was assessed by the EC Grading Scale. This method distinguishes four degrees of fibrosis (myelofibrosis [MF]-0 to MF-3). MF Grade (G) 0 is scattered linear reticulin with no intersections (cross-overs) corresponding to normal BM; MF Grade 1 is loose network of reticulin with many intersections, especially in perivascular areas; MF Grade 2 is diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF Grade 3 is diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis. Baseline is defined as the most recent centrally-reviewed BM biopsy prior to first dose of eltrombopag in the study.|Baseline|All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877. Participants with bone marrow biopsy data available in the relevant time period were included.|||Participants|||Number
1419967|NCT01098461|Secondary|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG|EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK/PD Analysis Pop: all participants in the PK Analysis Pop with sufficient dosing history for inclusion in the PK/PD analysis. Modeled population PK data (analyzed using a non-linear mixed effect modeling approach) are presented. A one-compartment PK model with first-order absorption/elimination processes was selected to describe GSK716155 PK.|||nanograms per milliliter||95% Confidence Interval|Mean
1419968|NCT01098461|Secondary|Mean Absorption Rate of Albiglutide|Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population (Pop)|||hour^-1||95% Confidence Interval|Mean
1419969|NCT01098461|Secondary|Mean Volume of Distribution of Albiglutide|Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, PK samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population|||Liters||95% Confidence Interval|Mean
1419981|NCT01098318|Primary|Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (17-items) at Week 8 and Week 12.|Hamilton Depression Rating Scale (HAM-D) is a validated, clinician-rated instrument for ascertaining the severity of MDD symptoms. The 28-item Hamilton Depression Rating Scale was used to determine the primary outcome of 17-item HAM-D score. The HAM-D will serves as the primary outcome measure. HAM-D17 score ranges from 0 to 68. Higher score indicates more depressed symptom.|12 weeks||||units on a scale||Standard Deviation|Mean
1419982|NCT01098305|Secondary|Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.|Side Effects|Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)||||participants|||Number
1419983|NCT01098305|Primary|7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.||At the end of treatment (12 weeks)||||participants|||Number
1419970|NCT01098461|Secondary|Mean Clearance of Albiglutide|Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 1, 4, 5, 8, 12, and 13) and on the day of the clinic visit at Weeks 16, 20, and 24. At Weeks 0, 1, 4, 8, and 12, pharmacokinetic (PK) samples were collected immediately prior to dosing if a dose was scheduled for that week. At Weeks 16, 20, and 24, PK samples were collected at any time during the visit. The Week 5 post-dose PK sampling was performed any time between Weeks 4 and 6, within 2 to 5 days after administration of a dose; Week 13 post-dose PK sampling was performed any time between Weeks 12 and 14, within 2 to 5 days after administration of a dose of study medication. Modeled population PK data are presented; data were analyzed using a non-linear mixed effect modeling approach. A one-compartment PK model with first-order absorption and elimination processes was selected to describe GSK716155 PK.|Weeks 0, 1, 4, 5, 8, 12, 13, 16, 20, and 24|PK Analysis Population: all participants for whom a PK sample was obtained and analyzed|||milliliters per hour||95% Confidence Interval|Mean
1419971|NCT01098461|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7% at Weeks 4, 8, 12, and 16|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7%) were assessed.|Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Participants|||Number
1419972|NCT01098461|Secondary|Change From Baseline in Body Weight at Week 4, 8, 12, and 16|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Kilograms||Standard Deviation|Mean
1419973|NCT01098461|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, and 16|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1419974|NCT01098461|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline; Week 4, Week 8, Week 12, and Week 16|ITT Population with LOCF. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1419975|NCT01098461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 16 minus the value at Baseline. Based on Analysis of Covariance (ANCOVA): Change = treatment + Baseline HbA1c + prior therapy. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.|Baseline and Week 16|Intent-to-Treat (ITT) Population: all randomized participants with at least one post-Baseline assessment of the primary endpoint, HbA1c. Only those participants with a value available at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were discontinued from active treatment before Week 16.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1419976|NCT01098318|Secondary|Number of Participants With Treatment Emergent Side Effects||12 weeks|All enrolled subjects were analyzed|||Participants|||Count of Participants
1419977|NCT01098318|Secondary|Number of Participants With Suicide Ideation as Determined by the Columbia Suicide Form|Descriptive analysis of number of subjects in each treatment group who had suicidal ideation at baseline and WK12.|12 weeks|All enrolled subjects were analyzed|||Participants|||Count of Participants
1419978|NCT01098318|Secondary|Change in Sexual Function|This is a patient completed rating of sexual function and satisfaction. It is used to assess current sexual health and changes in sexual health over time measured by the overall sexual satisfaction score. The reported score is the overall degree of sexual satisfaction attained. The score ranges from 0 to 100. Higher score indicates more sexual satisfaction.|12 weeks|All enrolled subjects were analyzed|||scores on a scale||Inter-Quartile Range|Median
1419979|NCT01098318|Secondary|Change in Depressive Symptoms as Measured by the Beck Depression Inventory|All enrolled subjects were analyzed. Mean change in Beck Depression Inventory (BDI) total scores were reported. BDI is a self-reported outcome measuring the severity of depression. A negative # means a reduction in BDI score at the end of treatment compared to baseline which represents an improvement in depression symptoms. BDI total score ranges from 0-63. BDI score of 1-16 represents low level of depression;17-30 represents moderate level of depression; >=31 represents significant level of depression. A reduction in the BDI score represents improvement in the depression symptoms.|12 weeks||||scores on a scale||Standard Deviation|Mean
1420021|NCT01098097|Primary|Incidence of Treatment Discontinuations Due to Adverse Events|All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks||||percentage of participants|||Number
1419984|NCT01098253|Secondary|Nine Item Patient Health Questionnaire (PHQ-9)|Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9). PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).|||Percentage of participants with PHQ-9 <5|||Number
1419985|NCT01098253|Primary|Hemoglobin A1C|HbA1c levels will be obtained in accordance with ADA guidelines (1) employing the in2it A1C Analyzer. The Analyzer offers accurate point of care HbA1c testing. Point of care testing using this device has acceptable precision and agreement in comparison with laboratory services|3 months|Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).|||Percentage of participants with HbA1c <7|||Number
1419986|NCT01098240|Other Pre-specified|The Sheehan Suicidality Tracking Scale (STS)|The Sheehan Suicidality Tracking Scale (STS) measures treatment-emergent suicidal ideation as well as behaviors. It can be administered by a clinician or filled in by a participant. Prior to analysis, the STS was mapped to the Columbia Classification Algorithm of Suicide Assessment(C-CASA) categories, which has 9-item including completed suicide, suicide attempt, preparatory acts, suicidal ideation, self-injurious behavior, self-injurious no intent, unknown fatal,unknown non-fatal or other not deliberate. Participants who were mapped to C-CASA items were reported.|Week 8 (double-blind baseline) and weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Participants|||Number
1419987|NCT01098240|Secondary|Plasma CP-601,927 Concentration|Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.|Week 11, 12 and 14|All randomized participants with at least one dose of study medication in DB (double blind) phase and one valid plasma concentration measurement collected during the DB phase was be included in the analyses of the PK endpoints. n = number of participants with evaluable data at each timeframe.|||ng/mL||Standard Deviation|Mean
1419988|NCT01098240|Secondary|Population Pharmacokinetics|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-601,927 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-601,927 concentrations|Weeks 11,12 and 14|||||||
1419989|NCT01098240|Secondary|Number of Participants With Response at Weeks 9 Through 14|Response was defined as greater than 50 percent reduction from double-blind baseline in MADRS total score.|Weeks 9 through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Participants|||Number
1419990|NCT01098240|Secondary|Number of Participants With Remission at Weeks 9, 10, 12 and 14|Remission was defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI-I score less than 2 (’much’ or ’very much’ improved).|Weeks 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Participants|||Number
1419991|NCT01098240|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14|CGI-I was defined as a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 8 (double-blind baseline) 9, 10, 12 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1419992|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14|SDS subscale is defined as a self-administered tool that measures functional impairment in 3-item including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale, for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1419993|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14|SDS is defined as a self-administered tool that measures functional impairment including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale (0=not at all impaired, 10=extremely impaired), for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1419994|NCT01098240|Secondary|Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14|The SIS is to rate suffering with regard to irritability symptoms. The degree to which irritability interferes with work, social and family function is also queried. The total SIS score is the sum of 7 items. Each item is rated on a scale of 0-10, for a total numeric range of scores from 0 (not at all) to 70 (extremely). The SIS also records the number of days impaired by irritability.|Weeks 8 (double-blind baseline), 11 and 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1420022|NCT01098097|Primary|Incidence of Thrombocytopenia|Thrombocytopenia is a low blood platelet count|Up to 12 Weeks||||percentage of participants|||Number
1430676|NCT01004354|Secondary|Adiponectin at Baseline and Post-treatment||Baseline and 8 weeks||||mcg/mL||Standard Deviation|Mean
1419995|NCT01098240|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14|CGI-S was defined as 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 8 (double-blind baseline) and weeks 9, 10, 12, 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1419996|NCT01098240|Secondary|Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14|The Bech Melancholia is sum of scores on 6 items (items 1, 2, 7, 8, 10 and 13) pertaining to melancholia within HAM-D. The items are rated on a scale of 0-4, higher scores reflecting greater severity. Total possible score is 0-24.|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1419997|NCT01098240|Secondary|Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14|The HAM-D25 is the 25-item version of a scale used to assess the range of depressive symptoms including depressed mood, work and activities, sleep, suicidal thinking, psychomotor agitation/retardation, appetite, sexual interest, anxiety, somatic symptoms, and cognitive symptoms. The items on the HAM-D were rated on a scale of 0-2 or 0-4, for a total numeric range of scores from 0 (depressive symptoms absent) to 72 (numerically highest level of depressive symptoms).|Weeks 8 (double-blind baseline) through 14|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1419998|NCT01098240|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline) and weeks 9 through 13|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1419999|NCT01098240|Primary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)|The full analysis set, which was defined as the set of all participants who consumed at least one dose of randomized study medication, was applied for the analysis. n = number of participants with evaluable data at each timeframe.|||Units on a scale||Standard Deviation|Mean
1420000|NCT01098162|Secondary|Incidence of Adverse Events During the Study|The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.|From Inclusion Visit (Day 0) up to Month 6|"All 571 subjects in the Safety Set are included in the analysis of this outcome measure.~Safety Set comprises all patients included who have been treated with Vimpat® at least once."|||participants|||Number
1420001|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.~Change in number of partial-onset seizures with secondary generalization was derived as follows:~Change in SF per 28 days = (SF at 6 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.~Partial-onset seizures with secondary generalization can be classified into one of the following three groups:~Simple partial seizures evolving to generalized seizures~Complex partial seizures evolving to generalized seizures~Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
1420002|NCT01098162|Secondary|Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.~Change in number of partial-onset seizures with secondary generalization was derived as follows:~Change in SF per 28 days = (SF at 3 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.~Partial-onset seizures with secondary generalization can be classified into one of the following three groups:~Simple partial seizures evolving to generalized seizures~Complex partial seizures evolving to generalized seizures~Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 447 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
1420049|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or CD39 and/or TNFR2.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420003|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval.~Change in number of partial-onset seizures was derived as follows:~Change in SF per 28 days = (SF at 6 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 6.~Partial-onset seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
1420004|NCT01098162|Secondary|Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3|"Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval.~Change in number of partial-onset seizures was derived as follows:~Change in SF per 28 days = (SF at 3 months per 28 days) – (SF at Baseline per 28 days).~A negative value in change from Baseline means that the value has decreased from Baseline to Month 3.~Partial-onset seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline to Month 3|"Of the 520 subjects in the Full Analysis Set (FAS), 449 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||Seizures per 28 days||Standard Deviation|Mean
1420005|NCT01098162|Primary|Clinical Global Impression of Change (CGI-C) at Month 6|"For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Month 6|"Of the 520 subjects in the Full Analysis Set (FAS), 515 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available."|||participants|||Number
1420006|NCT01098110|Secondary|Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders.|The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved).|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1420007|NCT01098110|Secondary|Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score.|The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420008|NCT01098110|Secondary|Percentage of Participants Who Were PANSS Responders.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder.|Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Percentage of participants||95% Confidence Interval|Number
1420009|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score.|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420010|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score.|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420011|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score.|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420012|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score.|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420013|NCT01098110|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score.|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420014|NCT01098110|Secondary|Change From Baseline in PANSS General Psychopathology Score.|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420015|NCT01098110|Secondary|Change From Baseline in PANSS Negative Symptom Score.|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420016|NCT01098110|Secondary|Change From Baseline in PANSS Positive Symptom Score.|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420017|NCT01098110|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.|Baseline and Day 42|All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the last observation carried forward (LOCF) method.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1420018|NCT01098097|Secondary|Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)|Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.|Week 12|The population analyzed was 920 participants who received at least 1 dose of study drug and had data collected at the Week 12 visit|||percentage of participants||95% Confidence Interval|Number
1420019|NCT01098097|Primary|Incidence of Dose Modifications Due to Adverse Events|All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.|Up to 12 Weeks||||percentage of participants|||Number
1420020|NCT01098097|Primary|Incidence of Particular Adverse Events Resulting in Treatment Discontinuation|"All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).~The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)"|Up to 12 Weeks||||percentage of participants|||Number
1420023|NCT01098097|Primary|Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.|Up to 12 Weeks||||percentage of participants|||Number
1420024|NCT01098071|Secondary|Severity of Eye Symptoms at Baseline and Week 12|Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
1420025|NCT01098071|Secondary|Severity of Sneezing at Baseline and Week 12|Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
1420026|NCT01098071|Secondary|Severity of Nasal Itching at Baseline and Week 12|Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
1420027|NCT01098071|Secondary|Severity of Nasal Congestion at Baseline and Week 12|Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
1420028|NCT01098071|Secondary|Severity of Rhinorrhea at Baseline and Week 12|Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).|Baseline and Week 12|Participants suspected to have allergic rhinitis|||Score on a scale||Full Range|Mean
1420029|NCT01098071|Primary|Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy||Baseline to 12 weeks|Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria)|||Participants|||Number
1420030|NCT01098071|Primary|Degree of Posterior Choana Obstruction at Baseline and Week 12|The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.|Baseline and Week 12|Only participants that completed the study are included.|||Percent obstruction||Full Range|Mean
1420031|NCT01098071|Primary|Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score|Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).|Baseline and Week 12||||Score on a scale||Full Range|Mean
1420032|NCT01098032|Secondary|The Cost-effectiveness Ratio.|Assessement of the cost-effectiveness ratio is important when testing a new strategy of both therapy and prophylaxis. The Renalguard system is more expensive than the conventional hydration regimen. The cost of RenalGuard system is approximately 800 $. This cost will be justified only if the system is more effective in preventing CI-AKI and improving the clinical outcome, expecially reducing the lenght of ospedalization and the rate of dialysis.|1 month|||||||
1420033|NCT01098032|Secondary|The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema)|Assessment of the rate of in-hospital major adverse events (i.e. acute myocardial infarction, c) renal failure requiring dialysis, and d) acute pulmonary edema) will give important informantion on the clinical relevance of prophylactic strategies in preventing CI-AKI|1 month|||||||
1420034|NCT01098032|Secondary|the Rate of Acute Renal Failure Requiring Dialysis|occurrence of renal failure requiring dialysis represents the haard endpoint of the study. Actually this represents the worst clinical consequence of CI-AKI.|1 month|||||||
1420035|NCT01098032|Secondary|Changes in the Urine and Serum NGAL Concentration After Contrast Exposure|NGAL is a new biomarker which seems to be very promising in detecting kidney injury. prelimiary data suggest that urine and serum NGAL increase very early (within few horurs) after the occurrence og acute kidney damage. Therefore, NGAL may be a real marker of acute kidney injury.|7 days|||||||
1420036|NCT01098032|Secondary|Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure|Cystatin C is an alternative biomarker of kidney damage. Cystatin C seems to be superior to serum creatinine an identifying kidney function and damage.|7 days|||||||
1420037|NCT01098032|Secondary|Rate of Kidney Injury and Major Adverse Events|an increase in the serum creatinine concentration >=0.25% and >=0.5 mg/dl at 48 hours after contrast exposure|7 days|||||||
1420038|NCT01098032|Primary|Number of Participants With Contrast-induced Acute Kidney Injury|The primary outcome measure will be the rate of development of CI-AKI in the 2 study arms (number of participants). CI-AKI is defined as an increase in the serum creatinine concentration >=0.3 mg/dL from the baseline value at 48 hours after administration of the contrast media or the need for dialysis.|at 48 hours following contrast exposure|all consecutive patients with chronic kidney disease scheduled for coronary and/or peripheral angiography and/or angioplasty with an estimated glomerular filtration rate (eGFR) ≤30 ml/min/1.73 m2 and/or a risk score ≥11 were considered eligible for the study|||participants|||Number
1420089|NCT01097694|Secondary|Bronchoalveolar Lavage (BAL) Fluid Tryptase Level|Change in BAL fluid tryptase levels after 24 weeks of imatinib vs. placebo|6 months after start of treatment||||ng/mL||Standard Deviation|Mean
1420090|NCT01097694|Secondary|Serum Total Tryptase|Change in serum total tryptase after 24 weeks of imatinib vs placebo treatment|6 months after start of treatment||||ng/ml||Standard Deviation|Mean
1420039|NCT01098006|Secondary|Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420040|NCT01098006|Secondary|Frequency of CD4+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Frozen Samples.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420041|NCT01098006|Secondary|Frequency of CD8+ Expressing CD40-L and/or IFNg and/or IL-2 and/or IL-17 in Fresh Samples.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420042|NCT01098006|Secondary|Frequency of CD4+ Expressing CD40-L and/or IFNg and/or Interleukin Receptor 2 (IL-2) and/or IL-17 in Fresh Samples.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420043|NCT01098006|Primary|Frequency of HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Frozen Samples.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420044|NCT01098006|Primary|Frequency of HBs- and HBc-specific CD4+Foxp3- Expressing CD69 and/or LAP in Fresh Samples.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420045|NCT01098006|Primary|Frequency of HBs- and HBc-specific CD4+Foxp3+ Expressing CD69 and/or LAP in Fresh Samples.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420046|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or CTLA4 and/or OX40.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420047|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or CTLA4 and/or OX40.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420048|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or CD39 and/or TNFR2.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420606|NCT01092910|Primary|Word Recognition Score Improvement|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|10 Months Post Activation||||improvement in % correct||Standard Error|Mean
1420050|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or CCR7 and/or CD62L.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420051|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or CCR7 and/or CD62L.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420052|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or GITR and/or Ki67.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420053|NCT01098006|Primary|Frequency of CD4+Foxp3+ Expressing CD45RA and/or GITR and/or Ki67.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420054|NCT01098006|Primary|Frequency of CD4+Foxp3- Expressing CD45RA and/or HLADR and/or ICOS and/or PD1.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420055|NCT01098006|Primary|Frequency of Cluster of Differentiation 4 (CD4) + Foxhead Box p3 (Foxp3) + Expressing CD45RA and/or Human Leucocyte Antigen DR Complex (HLA-DR) and/or Inducible T Cell Co-stimulator (ICOS) and/or PD1.|The frequency was assessed based on the following range of markers: CD4, CD25, CD45RA, CD45RO, ICOS, CD39, tumor necrosis factor receptor 2 (TNFR2), HLA-DR, PD-1, chemokine receptor 7 (CCR7), CD62L, OX40, glucocorticoid-induced tumor necrosis factor receptor-related protein (GITR), anti-Foxp3 and Ki67.|At Day 0|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all subjects who met all eligibility criteria, with a blood sample available and who had satisfied all specific criteria according to their specific group.|||Treg cells/million cells||Inter-Quartile Range|Median
1420056|NCT01097915|Secondary|Taste Perception of Sweet, Sour, Salty, Bitter and Umami and Changes Due to L-Arginine Supplementation, as a Functin of Genetic Ability to Taste PROP.|Taste perception was assessed by testing the ability to recognize, and the responsiveness to, representative solutions of the five taste qualities, also when supplemented with L-Arg, in subjects classified as PROP-tasters.|8 months||2017-12-31|12/2017||||
1420057|NCT01097915|Secondary|Association Between PROP Sensitivity and BMI|Since individual ability to taste PROP may be correlated with BMI, we determined BMI (kg/m^2) in subjects classified as super-taster, medium taster and non-taster.Weight (kg) and height (m) were recorded for each subject.|7 months||||Kg/m^2||Standard Error|Mean
1420058|NCT01097915|Secondary|Electrophysiological Recordings From the Tongue for the Objective Evaluation of Individual Variations of 6-n-propylthiouracil (PROP) Sensitivity|electrophysiological recordings from the tongue of 43 subjects classified for their taste sensitivity to 6-n- propyltiouracil (PROP) and genotyped for the specific receptor gene, TAS2R38. Density of fungiform papillae was also determined in each subject. The biopotentials were recorded by means of differential electrophysiological derivations between two silver electrodes, one in contact with the ventral surface of the tongue and one in perfect adhesion with the dorsal surface.|1 year||2018-06-30|06/2018||||
1420059|NCT01097915|Secondary|Association Between PROP Sensitivity and Saliva Zinc Ion Concentration|Since the enzymatic function of gustin (CA6) depends upon the presence of Zn at its active site we measured the salivary zinc ion concentration in subjects classified as super-taster, medium taster and non-taster.The salivary Zn2+ concentration was measured with a QuantiChromTM zinc Assay kit (Gentaur, Brussels, Belgium) where the color intensity is directly proportional to the Zn2+ concentration in the sample.|7 months||||microg/dl||Standard Error|Mean
1420060|NCT01097915|Primary|Association Between Gustin Gene Polymorphism and PROP Sensitivity|"We examine associations between PROP status and the polymorphism rs2274333 (A/G) of the gene that codify for the salivary protein, gustin/CA6, Which has been suggested as a trophic factor that promotes growth and development of taste buds by acting on taste bud stem cells.~The intensity of taste perception evoked by PROP and NaCl solutions was estimated to evaluate PROP taster status and molecular analysis of the gustin gene polymorphism was performed in individuals classified by PROP status using PCR techniques."|7 months||||percentage of participants|||Number
1420146|NCT01097304|Secondary|Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Ursodeoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention||Baseline and 6 months|analysis was limited to participants with baseline and 6-month gastric fluid|||% of total bile acid||Inter-Quartile Range|Median
1420061|NCT01097863|Primary|Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.|"As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion? The positive yes responses are reported."|1 week|Analysis conducted per protocol, with exclusions due to protocol deviations as determined by masked review (9), and unavailable data due to discontinuations (3).|||participants|||Number
1420062|NCT01097785|Secondary|Change in Measures of Reactive Oxygen Species in the Blood|Reactive Oxygen Species will be assessed after one month of placebo and statin therapy; measured using electron parametric resonance spectroscopy (EPR).|Baseline and 30 days||||EPR Arbitrary Units||Standard Error|Mean
1420063|NCT01097785|Primary|Change in Muscle Sympathetic Nerve Activity in Bursts Per 100 Heartbeats|Muscle sympathetic nerve activity will be assessed after one month of placebo and statin therapy; measured in bursts/100 heartbeats.|Baseline and 30 days||||bursts/100 heartbeats||Standard Error|Mean
1420064|NCT01097694|Secondary|Change in Number of Self-Reported Asthma Symptom Free Days||baseline to week 24|Self-reported asthma symptom free days were not entered into the study database.||||||
1420065|NCT01097694|Secondary|Change in Inflammatory Mediators in Exhaled Breath Condensate|Assessment of change in eicosanoids in the exhaled breath condensate|baseline to week 24|The exhaled breath condensate was not processed for inflammatory mediators.||||||
1420066|NCT01097694|Secondary|Change in Sputum Supernatant Differential, Supernatant Tryptase and IL-13|Change in sputum eosinophil and neutrophil percentage. Change in sputum supernatant tryptase as measured by ELISA. Change in sputum IL-13 level as measured by ELISA.|baseline to 24 weeks|"Sputum sample slide preparation quality was poor and samples meeting quality control were insufficient for analysis of sputum differential.~Insufficient study funds prevented assessment of sputum tryptase. IL-13 was below the detection limit of assay in sputum supernatant."||||||
1420067|NCT01097694|Secondary|Urinary Leukotriene E4|Change in urinary leukotriene E4 levels from baseline|6 months after start of treatment||||ng/mg Creatinine||Standard Deviation|Mean
1420068|NCT01097694|Secondary|Bronchoalveolar Lavage Cysteinyl Leukotrienes|Change in bronchoalveolar lavage cysteinyl leukotrienes levels from baseline|6 months after start of treatment||||pg/mL||Standard Deviation|Mean
1420069|NCT01097694|Secondary|Urinary Prostaglandin D2|Change in urinary Prostaglandin D2 levels from baseline|6 months after start of treatment||||ng/mg Creatinine||Standard Deviation|Mean
1420070|NCT01097694|Secondary|Bronchoalveolar Lavage Histamine|Change in bronchoalveolar lavage histamine levels from baseline|6 months after start of treatment||||nM||Standard Deviation|Mean
1420071|NCT01097694|Secondary|Airway Wall Area|Change in airway wall area as assessed by computerized tomography (CT)|6 months after start of treatment||||% of area||Standard Deviation|Mean
1420072|NCT01097694|Secondary|Airway Wall Thickness|Change in airway wall thickness as assessed by computerized tomography (CT)|6 months after start of treatment||||% of airway||Standard Deviation|Mean
1420073|NCT01097694|Secondary|Blood Eosinophils|Change in blood eosinophil count|6 months after start of treatment||||eosinophils per microliter||Standard Deviation|Mean
1420074|NCT01097694|Secondary|Endobronchial Biopsy Smooth Muscle Tryptase-positive Mast Cells|Change in the biopsy smooth muscle tryptase-positive mast cells from baseline at 6 months|6 months after start of treatment||||mast cells per mm2||Standard Deviation|Mean
1420075|NCT01097694|Secondary|Endobronchial Biopsy Total Tryptase-positive Mast Cells|Change in endobronchial biopsy total tryptase-positive mast cells from baseline at 6 months|6 months after start of treatment||||mast cells per mm2||Standard Deviation|Mean
1420076|NCT01097694|Secondary|Bronchoalveolar Lavage (BAL) PGD2|Change in bronchoalveolar lavage (BAL) PGD2 levels from baseline at 6 months|6 months after start of treatment||||pg/mL||Standard Deviation|Mean
1420077|NCT01097694|Secondary|BAL Eosinophil %|Change in BAL eosinophil percentage|6 months after start of treatment||||% eosinophils||Standard Deviation|Mean
1420078|NCT01097694|Secondary|BAL Neutrophil %|Change in BAL neutrophil percentage from baseline|6 months after start of treatment||||% neutrophils||Standard Deviation|Mean
1420079|NCT01097694|Secondary|Asthma Symptom Utility Index (ASUI)|Change in patient reported ASUI score The asthma symptom utility index (ASUI) is a 10-item weighted scale with a range from 0.2 to 1 with a higher value indicating improvement. The minimal important difference is 0.09.|6 months after start of treatment||||units on a scale||Standard Deviation|Mean
1420080|NCT01097694|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|Change in patient-reported Asthma Quality of Life Questionnaire (AQLQ) score The asthma quality of life questionnaire (AQLQ) is a 32-item scale with a range from 1-7 with a higher value denoting improvement. The minimal important difference is 0.5.|6 months after start of treatment||||units on a scale||Standard Deviation|Mean
1420081|NCT01097694|Secondary|Asthma Control Questionnaire (ACQ)|Change in patient-reported ACQ score The six-item Asthma Control Questionnaire (ACQ-6) is a scale from 0 to 6 with a lower value denoting an improvement in asthma control. The minimal important difference is 0.5.|6 months after start of treatment||||units on a scale||Standard Deviation|Mean
1420082|NCT01097694|Secondary|Fractional Exhaled Nitric Oxide (FeNO)|Change in Fractional Exhaled Nitric Oxide Measurement (ppb)|6 months after start of treatment||||parts per billion||Standard Deviation|Mean
1420083|NCT01097694|Secondary|Evening Peak Flow|Change in patient-reported evening peak flow measurement (L/s)|6 months after start of treatment||||L/second||Standard Deviation|Mean
1420084|NCT01097694|Secondary|Morning Peak Flow Measurement|Change in patient-reported morning peak flow measurement (L/s)|6 months after start of treatment||||L/second||Standard Deviation|Mean
1420085|NCT01097694|Secondary|FEV1%|Change in FEV1% of predicted|6 months after start of treatment||||% of predicted||Standard Deviation|Mean
1420086|NCT01097694|Secondary|FEV1 in Liters|Change in FEV1 in treatment group compared to placebo group|6 months after start of treatment||||L||95% Confidence Interval|Mean
1420087|NCT01097694|Secondary|Number of Asthma Exacerbations|Number of asthma exacerbations experienced from randomization to study completion.|Up to 24 weeks||||events|||Number
1420088|NCT01097694|Secondary|Change in Maximum Post-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) %||6 months after start of treatment||||% of predicted||Standard Deviation|Mean
1420091|NCT01097694|Primary|Change in Mean Methacholine Responsiveness as Assessed by the Provocation Concentration Causing a 20% Fall in Forced Expiratory Volume in One Second (FEV1) (PC20) at Month 3 and 6 Versus Baseline|"Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between the two groups.~PC20 is determined by the provocation concentration of methacholine causing a 20% fall in forced expiratory volume in one second (FEV1)."|Over 6 months from beginning of treatment||||Log2 Ratio||Standard Deviation|Mean
1420092|NCT01097668|Secondary|The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).|Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.|16 and 20 weeks|ITT population at week 16 and 20 n=21 (Intradermal injection) ITT population at week 16 and 20 n=22 (Subcutaneous injection) MRI population at week 16 and 20 n=17 (Intradermal injection) MRI population at week 16 and 20 n=20 (Subcutaneous injection)|||MRI lesions||95% Confidence Interval|Mean
1420093|NCT01097668|Primary|Safety and Tolerability|Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.|48 weeks|The Safety population will be denoted as the ‘ITT population’ for the summarisation of safety endpoints.|||participants|||Number
1420094|NCT01097655|Other Pre-specified|Prevalence of Adverse Events (Weeks 0-144), Per Participant|Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of participants|||Number
1420095|NCT01097655|Other Pre-specified|Prevalence of Adverse Events (Weeks 0-144), Per Event|Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of adverse events|Adverse Events||Number
1420096|NCT01097655|Primary|Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load|Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||log copies/mL||Standard Deviation|Mean
1420097|NCT01097655|Primary|Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count|Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||cells/μL||Standard Deviation|Mean
1420098|NCT01097629|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
1420099|NCT01097629|Primary|Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
1420100|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420115|NCT01097616|Primary|Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
1420239|NCT01096550|Primary|Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)||6 months post-baseline||||percentage of opioid dependent subjects|||Number
1420101|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420102|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420103|NCT01097629|Secondary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420104|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420105|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420106|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420107|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420240|NCT01096446|Secondary|Initiation of Glucose|Infants were monitored to see if insulin was started to control hyperglycemia.|First 7 days of life|||||||
1420108|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420109|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420110|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420111|NCT01097629|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420112|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420113|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420114|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
1420241|NCT01096446|Secondary|Maintain Appropriate for Gestational Age Status at Discharge|Recorded all infant's weights at discharge and plotted the anthropometric values on the Fenton Growth Charts.|Entire hospital stay|||||||
1420116|NCT01097616|Primary|Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.|Up to 3 months|All Patients as Treated (APaT) population, consisting of all randomized participants who received at least one dose of study medication|||participants|||Number
1420117|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420118|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420119|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
1420120|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420121|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420122|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Night 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
1420144|NCT01097304|Secondary|Changes in Cell Proliferation in BE Epithelium From Baseline to Post-intervention as Assessed by Proliferation-related Ki-67 Antigen (Ki67) Immunostaining, Percentage of Positively Stained Nuclei, in BE Tissue Sections|Results will be analyzed using paired t-tests. Results (mean values and changes during intervention) will be reported along with the corresponding confidence intervals.|Baseline and 6 months|tissue slides with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis|||% change||Standard Deviation|Mean
1420123|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420124|NCT01097616|Secondary|Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. Only suvorexant LD-placebo comparison included, as suvorexant HD-placebo comparison is included in Primary hypothesis.|||minutes||95% Confidence Interval|Least Squares Mean
1420125|NCT01097616|Secondary|Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Week 1 range is Days 2-8 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Week 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis.|||minutes||95% Confidence Interval|Least Squares Mean
1420126|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420127|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1|"LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment (Lights-Off) to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420128|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420129|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1|sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1430677|NCT01004354|Secondary|Triglycerides at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
1420130|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 3|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420131|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1|"WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment (Lights-Off) is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording (Lights-On). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center."|Baseline and Month 1|Randomized participants with ≥1 post-randomization PSG observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420132|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 3|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420133|NCT01097616|Primary|Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1|sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography [PSG] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.|Baseline and Month 1|Randomized participants with ≥1 post-randomization e-diary observation after ≥1 dose of study drug, and baseline data were included in this analysis. The Primary hypothesis included only the suvorexant HD-placebo comparison.|||minutes||95% Confidence Interval|Least Squares Mean
1420134|NCT01097460|Secondary|To Determine the Recommended Phase 2 Doses of MM-111 + Herceptin in Combination||2 years|||||||
1420135|NCT01097460|Primary|Incidence of Treatment-emergent AE’s||2 years|Patients that received at least one dose|||participants|||Number
1420136|NCT01097421|Secondary|Patients Global Impressions (PGI)|Assessed by asking the patient at the final visit which alternative described how they had felt during the last 7 days as compared to how they felt at the baseline observation.|8-12 weeks|FAS|||Participants|||Number
1420137|NCT01097421|Secondary|Clinical Global Impressions (CGI)|Clinical Global Impression (CGI) scale at final visit|8-12 weeks|FAS|||Participants|||Number
1420138|NCT01097421|Secondary|Pramipexole (PPX) Dose|mean Pramipexole (PPX) dose|pre-treatment and after 8-12 weeks|FAS|||mg/24 hr||Standard Deviation|Mean
1420139|NCT01097421|Secondary|Adverse Events (AE) Considered Related to Observed Medication|Some patients had not related AEs as well as related AEs.|8-12 weeks|Safety Analysis Set (SAS) defined as all treated patients with a documented baseline observation.|||Patients|||Number
1420140|NCT01097421|Secondary|Patient Preference|Patients were asked about their preference regarding frequency of intake (once daily or three times daily)|8-12 weeks|FAS|||Participants|||Number
1420141|NCT01097421|Primary|Level of Adherence|Points on Morisky scale|8-12 weeks|FAS|||Participants|||Number
1420142|NCT01097421|Primary|Patients With a Score of 4 in Morisky Scale After 8-12 Weeks of Treatment|Morisky scale: 4 Yes/No Questions: Do you ever forget to take your medicine? Are you careless at times about taking your medicine? When you feel better do you sometimes stop taking your medicine? Sometimes if you feel worse when you take the medicine, do you stop taking it? Score one point for every NO: 0-1 points = low adherence, 2-3 points = moderate, 4 points = high adherence Confidence interval computed using the Clopper-Pearson (exact) method.|8-12 weeks|Full Analysis Set (FAS) defined as all patients who had taken at least one dose of the investigational medicinal product (IMP) and had a post-baseline assessment.|||Percent||95% Confidence Interval|Number
1420143|NCT01097343|Primary|Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230|P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.|Approximately 90 days|All patients completed the clinical protocol.|||Number of Patients with PRU>230|||Number
1420145|NCT01097304|Secondary|Changes in Gastric Bile Acid Composition (Change in Percent of Total Bile Acid Present as Deoxycholic Acid and Its Glycine/Taurine Conjugates) Measured by Liquid Chromatography-tandem Mass Spectrometry, From Baseline to Post-intervention||Baseline and 6 months|analysis was limited to participants with baseline and 6-month gastric fluid|||% of total bile acid||Inter-Quartile Range|Median
1420147|NCT01097304|Primary|Reversal of Oxidative DNA Damage as Assessed by Changes in 8-hydroxy-2' -Deoxyguanosine (8OHdG) Immunostaining|8OHdG will be assessed by percentage of positively stained nuclear area. A paired t-test at a one-sided 0.05 significance level will be used to assess change during intervention. The observed results will be reported along with the corresponding confidence intervals.|Baseline to 6 months|participants with fewer than 500 total nuclei in longitudinally sectioned crypts opening to the lumen were excluded from analysis|||% of strongly/moderately stained nuclei||Standard Deviation|Mean
1420148|NCT01097057|Primary|Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days|Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days|Up to Four Apheresis Days|Note: No patients were in this category.|||Participants|||Count of Participants
1420149|NCT01097057|Primary|Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg|Number of participants requiring one or two apheresis collection days to reach collection goal.|Up to Four Apheresis Days||||Participants|||Count of Participants
1420150|NCT01097057|Primary|Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days|Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures.|Up to Four Apheresis Days||||Participants|||Count of Participants
1420151|NCT01097057|Primary|Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)|Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis.|One Month||||Participants|||Count of Participants
1420152|NCT01097005|Secondary|Bacteriological Relapse Related to Duration of Clarithromycin Administration|Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion|36 months|End of study (completers). Analysis of bacteriological relapse.|||participants|||Number
1420153|NCT01097005|Secondary|"Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator"|"Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales (Effective, Ineffective, Deterioration, Impossible)"|When treatment with clarithromycin is discontinued, from 40 days to 1232 days|Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.|||Number of patients|||Number
1420154|NCT01097005|Primary|Bacilli Negative Conversion Rate|Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin|During the treatment with clarithromycin, from 40 days to 1232 days|Analysis of the bacilli negative conversion|||participants|||Number
1420155|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||5 days postoperatively||||mg/L||Standard Error|Mean
1420156|NCT01096875|Secondary|High Sensitive C-reactive Protein (hsCRP mg/L)||Postoperative 6th hours||||mg/L||Standard Error|Mean
1420157|NCT01096875|Secondary|Left Ventricular Ejection Fraction (LVEF %) Measured at 30 Days Postoperatively||Change between statin and placebo groups at 30 days postoperatively||||percentage of LVEF||Standard Deviation|Mean
1420158|NCT01096875|Primary|Endothelial Progenitor Cells (EPCs) Count (Cells/µl)||Postoperative 6th hours||||cells/µl||Standard Error|Mean
1420159|NCT01096849|Secondary|Percentage of Patients With a Superinfection or New Infection in the ME Population|Superinfections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after the first infusion through EOT. New infections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after EOT.|Day 1 to to End of Study (Day 40)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients|||Number
1420160|NCT01096849|Secondary|Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population|Patients who had a clinical relapse (defined as the return of clinical signs and symptoms requiring antibiotic therapy) or microbiological recurrence (defined as eradication of the original pathogen[s] at the TOC visit but regrowth at the level >10^5 CFU/mL by the LTFU [long term follow up] visit).|Day 1 to LTFU (Day 40)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients|||Number
1420161|NCT01096849|Secondary|Time (Days) to Defervescense in the MITT Population|Defervescence is defined as the absence of fever <37.7 degrees Celsius and is assessed in patients who were afebrile at baseline.|Day 1 to End of Study (Day 40)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||days||Standard Error|Mean
1420162|NCT01096849|Secondary|Time (Days) to Clinical Cure Based on Investigator’s and Sponsor’s Assessments in the MITT Population|"Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit.~The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to End of Study (Day 40)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||days||Standard Error|Mean
1420163|NCT01096849|Secondary|Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population|Resolution of clinical signs and symptoms is defined as absence of all signs and symptoms present at baseline.|Day 1 to End of Study (Day 40)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||days||Standard Error|Mean
1420164|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
1420165|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
1420166|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients|||Number
1420167|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to EOT (Day 5)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||percentage of patients||95% Confidence Interval|Number
1420168|NCT01096849|Secondary|Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to EOT (Day 5)|The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
1420169|NCT01096849|Secondary|Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population|"Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the EOT visit.~The Sponsor's assessment criteria was programmatically based on the investigator’s assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to EOT (Day 5)|The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC.|||percentage of patients||95% Confidence Interval|Number
1420170|NCT01096849|Secondary|Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population|"Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit.~The sponsor's assessment criteria was programmatically based on the investigator’s assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to TOC (Day 12)|The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC.|||percentage of patients||95% Confidence Interval|Number
1420171|NCT01096849|Secondary|Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population|"Investigator's assessment criteria defined Clinical Cure as resolution of baseline clinical signs and symptoms of infection through the TOC visit.~The sponsor's assessment criteria was programmatically based on the investigator’s assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered."|Day 1 to TOC (Day 12)|The intent-to-treat (ITT) population was defined as all randomized patients.|||percentage of patients||95% Confidence Interval|Number
1420172|NCT01096849|Primary|Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)|An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.|Day 1 to the end of study (Day 40)|The Safety population was defined as all randomized patients who received any amount of study drug.|||percentage of patients|||Number
1420173|NCT01096849|Primary|Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The ME population was defined as clinically evaluable (CE) patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC.|||percentage of patients||95% Confidence Interval|Number
1420174|NCT01096849|Primary|Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population|MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 colony forming unit(s) per milliliter (CFU/mL) were reduced to <10^4 CFU/mL.|Day 1 to TOC (Day 12)|The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen.|||percentage of patients||95% Confidence Interval|Number
1420242|NCT01096446|Secondary|Infants Will Achieve 90 Calories/Kilogram/Day|Monitored the calorie intake of infants to see which group was able to acheive 90 cal/kg/day from the total parenteral nutrition.|First 14 days of Life|||||||
1420175|NCT01096823|Primary|Disease Activity Scale (DAS)28|"is a combined index that measures disease activity in patients with RA and remains a more thorough, established alternative to standard medical exams. This index includes a 28 tender joint count, 28 swollen joint count, Erythrocyte Sedimentation Rate (ESR), and general health assessment using a visual analogue scale. The ESR indirectly measures inflammation in the body and involves collecting blood samples, which will be performed by a qualified phlebotomist.~The DAS score is a complicated formula based on many factors so there are no set ranges, but the published standards are as follows:~A DAS28 score of higher than 5.1 is indicative of high disease activity, whereas a DAS28 below 3.2 indicates low disease activity. A patient is considered to be in remission if they have a DAS28 lower than 2.6. Source: DAS-Score.nl. Available at http://www.das-score.nl/www.das-score.nl/index.html. Accessed February 5, 2009."|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
1420176|NCT01096823|Primary|Health Assessment Questionnaire (HAQ)|"Items include questions about dressing and grooming, rising, eating, walking, hygiene, reaching, grip and making activities. The HAQ is one of the most widely recognized measures of patient functioning, with acceptable reliability and validity. It has been used successfully with adolescents as young as 13 years of age~Range: 0-100, lower scores indicate better health"|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
1420177|NCT01096823|Primary|Pain Disability Index (PDI)|"The PDI assess the impact of pain on ability to participate in basic life activities, including social activity, sexual behavior, self-care and life-support activity. The PDI has been used with patients as young as 15. Good internal reliability (α = .82) and validity have been reported. It takes less than 5 minutes to complete.~7 items, total measure range: 0-70, higher scores = higher interference/disability"|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
1420178|NCT01096823|Primary|Health Related Quality of Life - Short Form-36 (SF-36)|"The Health Related Quality of Life - Short Form-36 (SF-36) is a generic core HRQOL measure yielding an 8-scale profile of functional health and well being. The SF-36 performs comparatively better than other HRQOL measures in terms of reliability, validity, lightness of respondent/administrative burden. It can be completed in 5-10 minutes and has been used with children as young as 10 years of age.~Subscales - all ranges 0-100 with higher scores indicating increased quality of life Bodily Pain, 2 items General Health, 5 items Vitality, 4 items Mental Health, 5 items"|post intervention (within 2 weeks of completing intervention)||||units on a scale||Standard Deviation|Mean
1420179|NCT01096810|Secondary|Antitumor Effect|To study the possible mechanisms involved in the clinical antitumor effect with determination of inhibition of angiogenesis|Antitumor effect|immunophenotyping was not performed in this study||||||
1420180|NCT01096810|Primary|Response Rate|"The response rate - percentage of participants with overall response.~Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least >50% reduction in SPEP, at least >90% reduction or <200 mg in UPEP, at least >50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate."|from date of start of treatment until the date of best documented response up to date of progression||||percentage of participants|||Number
1420181|NCT01096810|Primary|Time to Progression|"To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles).~Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: >25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), >25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), >25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause)."|From date of treatment until the date of first documented progression||||cycles||Full Range|Median
1420182|NCT01096784|Secondary|Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3||Day 7 and Week 40 Post Menstrual Age|FAS.|||microgram per liter||Standard Deviation|Mean
1420183|NCT01096784|Secondary|Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3||Day 0 and Week 40 Post Menstrual Age|FAS.|||microgram per liter||Standard Deviation|Mean
1420184|NCT01096784|Secondary|Percentage of Serum IGF-1 Concentrations Falling Within Target Range After Infusion of rhIGF-1/rhIGFBP-3|Serum samples were collected from treated and control participants for quantification of IGF-1 using validated immunoassays. Target range of serum IGF-1 was 28-109 mcg/L. The percentage of serum IGF-1 levels across treated participants that fall within the range was reported.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS was analysed.|||percentage of serum concentration|||Number
1420185|NCT01096784|Secondary|Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|Safety Analysis Set (SAF) included all randomized participants who received the study drug and participants in the control group who received standard of care, and for whom at least 1 safety assessment was completed.|||participants|||Number
1420186|NCT01096784|Secondary|Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study|ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome.|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS.|||Percentage of participants|||Number
1430678|NCT01004354|Secondary|Total Cholesterol at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
1420187|NCT01096784|Secondary|Area Under Curve for Maximum Severity of ROP Stage (AUC for ROP)|Integration of the maximum severity of ROP stage and the duration of the time interval with respect to each retinal examination. AUC for the maximum severity of ROP was calculated using the trapezoidal rule. The area between each 2 visits was calculated by multiplying the average of the maximum severities of the 2 visits by the difference in days and analyzed using the van Elteren test. ROP is classified according to the International Classification and is subdivided into 5 stages (1-5) with higher values representing greater severity.|Every 1-2 weeks starting at 31 weeks PMA/ EOS +/- 4 days|Full analysis set with number of participants evaluable for this outcome.|||ROP severity score*days||Standard Deviation|Mean
1420188|NCT01096784|Secondary|Percentage of Participants With Intraventricular Hemorrhage (IVH)|Development of intraventricular hemorrhage was assessed by cerebral ultrasound and coded as a binary endpoint (presence or absence of IVH).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||percentage of participants|||Number
1420189|NCT01096784|Secondary|Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS|Brain volume was measured using cerebral magnetic resonance imaging (MRI). Brain volume included cerebrospinal volume, gray matter volume, white matter volume, and total cerebellar volume|40 Weeks PMA/ (EOS) +/- 4 days|FAS|||cubic centimeter||Standard Deviation|Mean
1420190|NCT01096784|Secondary|Rate of Change in Head Circumference|The rate of change is the head circumference change per day in centimetre (cm).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||cm/day||95% Confidence Interval|Mean
1420191|NCT01096784|Secondary|Rate of Change in Length|The rate of change is the length change per day in centimeter (cm).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||centimeter per day (cm/day)||95% Confidence Interval|Mean
1420192|NCT01096784|Secondary|Rate of Change in Body Weight|The rate of change is the rate of specific body weight change per day in kilogram (kg).|Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS|||kilogram per day (kg/day)||95% Confidence Interval|Mean
1420193|NCT01096784|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)|"Severity of BPD as mild, moderate and severe were based on the National Institute of Child Health and Human Development (NICHD) guidelines for preterm infants born at gestational age (GA) less than (<) 32 weeks.~Mild: oxygen requirement during the first 28 days but in room air at PMA 36 weeks or discharge to home, whichever comes first.~Moderate BPD: oxygen requirement during the first 28 days and oxygen <30 percent (%) at PMA 36 weeks or discharge to home, whichever comes first.~Severe BPD: oxygen requirement during the first 28 days and oxygen greater than equal (≥)30% through head hood or nasal canula, or continuous positive airway pressure, or mechanical ventilation, or high flow nasal cannula ≥2 L/min at PMA 36 weeks or discharge to home, whichever comes first."|At 36 Weeks Post Menstrual Age|FAS with participants evaluable for this outcome.|||participants|||Number
1420194|NCT01096784|Secondary|Time to Discharge From Neonatal Intensive Care (TDNIC)||Day 0 to 40 Weeks Post Menstrual Age (EOS)|FAS with number of participants evaluable for this outcome.|||Days||Full Range|Median
1420195|NCT01096784|Primary|Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population|ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).|End of study|Full Analysis Set (FAS) included all randomized participants who received the study drug and participants in the control group who received Standard of Care.|||participants|||Number
1420196|NCT01096771|Secondary|Hypertriglyceridemia|Defined as triglyceride level >400|96 hours||||participants|||Number
1420197|NCT01096771|Secondary|Allergic Reactions||96 hours||||participants|||Number
1420198|NCT01096771|Secondary|Hospital Length of Stay||30 days||||days||Standard Deviation|Mean
1420199|NCT01096771|Secondary|Biomarkers (C-reactive Protein)||96 hours||||mg/L||Standard Deviation|Mean
1420200|NCT01096771|Secondary|Organ Failures||30 days||||participants|||Number
1420201|NCT01096771|Secondary|New Infection|We will use standard clinical criteria including but not limited to: fever, pyuria, new inflitrate on chest x-ray, positive blood cultures, abscess detected on imaging, leukocytosis, and positive skin or soft-tissue cultures to identify presence of new bacterial infections occurring after enrollment.|30 days||||participants|||Number
1420202|NCT01096771|Secondary|30 Day Mortality||30 days||||participants|||Number
1420203|NCT01096771|Secondary|PaO2:FiO2 Ratio|PaO2:FiO2 ratio at time of 2nd Bronchoalveolar Lavage (BAL) or end of study drug administration.|4 days||||mmHg||Standard Deviation|Mean
1420204|NCT01096771|Secondary|Ventilator Days||30 days||||days||Standard Deviation|Mean
1420205|NCT01096771|Primary|Bronchoalveolar Lavage Fluid Interleukin-8 Concentrations||96 hours|Each arm has one less subject than specified in the participate flow module. One is secondary to the fact that the subject refused the 2nd bronchoscopy and the other is because the primary physician felt the subject was too sick to undergo the 2nd bronchscopy.|||pg/mL||Standard Deviation|Mean
1420206|NCT01096680|Secondary|PVT Scores by Timepoint|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS|||msec||Standard Error|Least Squares Mean
1420207|NCT01096680|Secondary|Psychomotor Vigilance Task (PVT) Scores|PVT assesses behavioral alertness. Subjects were required to respond to a visual stimulus by pressing a button on a mechanical device and the reaction time was measured. Higher scores indicate attention lapses.|Over a period of 12 hours|FAS|||msec||Standard Error|Least Squares Mean
1420208|NCT01096680|Secondary|KSS Scores by Timepoint|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS|||Units on a scale||Standard Error|Least Squares Mean
1420209|NCT01096680|Secondary|Karolinska Sleepiness Scale (KSS) Scores|The KSS is a 9-point scale on which the subject rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep). Lower score is better.|Over a period of 15 hours|FAS|||Units on a scale||Standard Error|Least Squares Mean
1420210|NCT01096680|Primary|Maintenance of Wakefulness Test (MWT)|"The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to stay awake as long as possible during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better."|Over a period of 8 hours|Full Analysis Set (FAS) is defined as all randomized subjects with any primary efficacy assessment.|||Minutes||Standard Error|Least Squares Mean
1420211|NCT01096667|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug. Discontinuation of study drug due to an AE includes temporary and permanent discontinuation of study drug due to an AE.|Up to 28 days (treatment period)|Analysis population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1420212|NCT01096667|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. The table below includes all data collected since first dose of study drug.|Up to 63 days (including run-in, treatment period, and follow-up)|Analysis population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1420213|NCT01096667|Secondary|Change From Baseline in FPG at Week 2|For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).|Baseline and Week 2|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 2 for FPG (observed cases).|||mg/dL||80% Confidence Interval|Least Squares Mean
1420214|NCT01096667|Secondary|Change From Baseline in FPG at Week 4|For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement at Week 4 for FPG (observed cases).|||mg/dL||80% Confidence Interval|Least Squares Mean
1420215|NCT01096667|Secondary|Baseline Fasting Plasma Glucose (FPG)|For FPG, blood was drawn after an overnight fast of at least 8 hours (except water).|Baseline|All randomized participants.|||mg/dL||Standard Deviation|Mean
1420216|NCT01096667|Secondary|Change From Baseline on 24-hour Urinary Glucose Excretion at Week 4|Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as >20 hours and <28 hours). In the case of missing data, LOCF.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for 24-hour urinary glucose excretion.|||grams/day||80% Confidence Interval|Least Squares Mean
1420217|NCT01096667|Secondary|Baseline 24-hour Average Urinary Glucose Excretion|Urinary glucose excetion was corrected for a duration of 24 hours (with appropriate duration of collection defined as >20 hours and <28 hours).|24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average urinary glucose excretion|||grams/day||Standard Deviation|Mean
1420218|NCT01096667|Secondary|Change From Baseline in Seated, Triplicate Trough Heart Rate at Week 4|Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough heart rate.|||beats per minute||80% Confidence Interval|Least Squares Mean
1420219|NCT01096667|Secondary|Baseline Seated, Triplicate Trough Heart Rate|Trough heart rate was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the heart rate measure was obtained. Three measurements of heart rate were taken at least 2-minutes apart. Baseline trough heart rate is calculated as the mean of triplicate (3) trough heart rate measures.|Baseline|All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough heart rate.|||beats per minute||Standard Deviation|Mean
1420220|NCT01096667|Secondary|Change From Baseline on Nighttime Average Heart Rate at Week 4|Change from baseline in 24-hour nighttime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||Beats per minute||80% Confidence Interval|Least Squares Mean
1420221|NCT01096667|Secondary|Change From Baseline on Daytime Average Heart Rate at Week 4|Change from baseline in daytime average heart rate at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||Beats per minute||80% Confidence Interval|Least Squares Mean
1420222|NCT01096667|Secondary|Change From Baseline on 24-hour Average Heart Rate at Week 4|Change from baseline in 24-hour average heart rate at Week 4 using 24 hour ABPM.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||Beats per minute||80% Confidence Interval|Least Squares Mean
1420223|NCT01096667|Secondary|Baseline 24-hour, Daytime and Nightime Average Heart Rate|Baseline 24-hour average heart rate was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|up to 24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime heart rate.|||beats per minute||Standard Deviation|Mean
1430679|NCT01004354|Secondary|LDL-cholesterol at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
1420224|NCT01096667|Secondary|Change From Baseline in Seated, Triplicate Trough DBP at Week 4|Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough DBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420225|NCT01096667|Secondary|Baseline Seated, Triplicate Trough DBP|Trough DBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough DBP is calculated as the mean of triplicate (3) trough DBP measures.|Baseline|All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough DBP.|||mmHg||Standard Deviation|Mean
1420226|NCT01096667|Secondary|Change From Baseline on Nighttime Average DBP at Week 4|Change from baseline on nighttime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420227|NCT01096667|Secondary|Change From Baseline on Daytime Average DBP at Week 4|Change from baseline on daytime average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420228|NCT01096667|Secondary|Change From Baseline on 24-hour Average DBP at Week 4|Change from baseline on 24-hour average DBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420229|NCT01096667|Secondary|Baseline 24-hour, Daytime and Nightime Average Diastolic Blood Pressure (DBP)|Baseline 24-hour average DBP was assessed using 24-hour ABPM. Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|up to 24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour, daytime and nighttime DBP.|||mmHg||Standard Deviation|Mean
1420230|NCT01096667|Secondary|Change From Baseline in Seated, Triplicate Trough SBP at Week 4|Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. The change from baseline at Week 4 is the difference between the baseline and Week 4 assessments.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and post-randomization measurement for sitting, triplicate trough SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420231|NCT01096667|Secondary|Baseline Seated, Triplicate Trough SBP|Trough SBP was measured using an automated blood pressure device with the participant in a seated position for at least 5 minutes before and while the blood pressure measure is obtained. Three measurements of blood pressure were taken at least 2-minutes apart. Baseline trough SBP is calculated as the mean of triplicate (3) trough SBP measures.|Baseline|All randomized participants who received at least one dose of study drug and had a baseline measurement for seated, triplicate, trough SBP.|||mmHg||Standard Deviation|Mean
1420232|NCT01096667|Secondary|Change From Baseline on Nighttime Average SBP at Week 4|Change from baseline on nighttime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420233|NCT01096667|Secondary|Change From Baseline on Daytime Average SBP at Week 4|Change from baseline on daytime average SBP at Week 4 using 24 hour ABPM. In the case of missing data, LOCF. Daytime was defined as 0600 to 2159 hours, inclusive, local time.|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420234|NCT01096667|Secondary|Baseline Average Daytime and Nighttime SBP|Daytime was defined as 0600 to 2159 hours, inclusive, local time. Nighttime was defined as 2200 to 0559 hours, inclusive, local time.|Daytime: 16 hours; Nighttime: 8 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for daytime and nighttime SBP.|||mmHg||Standard Deviation|Mean
1420235|NCT01096667|Primary|Change From Baseline on 24-hour Average SBP at Week 4|Change from baseline on 24-hour average SBP at Week 4 assessed using 24-hour ABPM. In the case of missing data, last observation carried forward (LOCF).|Baseline and Week 4|Analysis population consisted of all randomized participants who received at least 1 dose of blinded treatment and had baseline measurement and a post-randomization measurement for average, 24-hour SBP.|||mmHg||80% Confidence Interval|Least Squares Mean
1420236|NCT01096667|Primary|Baseline 24-hour Average Systolic Blood Pressure (SBP)|Baseline 24-hour average SBP was assessed using 24-hour ambulatory blood pressure monitoring (ABPM).|24 hours|All randomized participants who received at least one dose of study drug and had a baseline measurement for average 24-hour SBP.|||mmHg||Standard Deviation|Mean
1420237|NCT01096589|Secondary|Assessment of Safety by Incidence of Adverse Events.||3 weeks|||||||
1420238|NCT01096589|Primary|Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.||baseline and after 3 weeks of treatment|Patients must have completed the first week.|||% volume change measured in mL.||Standard Deviation|Mean
1420244|NCT01096446|Primary|Number of Infants Serum Triglyceride Level Higher Than 200 mg/dl|Each day the infants have a serum triglyceride level drawn to assess their tolerance of the intravenous fat emulsion being given.|First 7 days of life|This study was ended early due to 100% of the infants in the experimental group developed hypertriglyceridemia of 200 mg/dl or greater|||participants|||Number
1420245|NCT01096342|Secondary|Duration of Response|The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Date at which the patient's objective status is first noted to be either an sCR, CR, PR, or VGPR to the earliest date progression is documented, assessed up to 3 years|Duration of Response was not analyzed due to lack of responses.||||||
1420246|NCT01096342|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 3 years|All 15 evaluable participants were analyzed for Progression-Free Survival.|||months||95% Confidence Interval|Median
1420247|NCT01096342|Primary|Number of Confirmed Responses, Defined to be an sCR, CR, VGPR, or PR Noted as the Objective Status on Two Consecutive Evaluations.|"Complete Response (CR):~Negative immunofixation of serum and urine Normalization of FLC ratio < 5% plasma cells in bone marrow Disappearance of any soft tissue plasmacytomas~Stringent Complete Response (sCR):~CR, as above, with absence of clonal cells in bone marrow~Partial Response (PR):~One of the following:~A ≥ 50% reduction of measurable serum M-protein.~A reduction in 24h measurable urinary M-protein by ≥ 90% or to <200 mg per 24h.~A ≥ 50% decrease in the difference between involved and uninvolved FLC levels.~≥50% reduction in bone marrow plasma cells is required in place of Mprotein, provided baseline percentage was ≥ 30%~A ≥50% reduction in the size of soft tissue plasmacytomas.~Very Good Partial Response (VGPR):~PR as defined above in addition to having serum and urine M-component detectable by immunofixation but not on electrophoresis."|Up to 3 years|Fifteen of the 16 accrued Phase II participants were analyzed (1 participant was a protocol violation).|||participants|||Number
1420248|NCT01096316|Secondary|Potential Facilitators and Barriers to Sustainability|Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.|18 months|||||||
1420249|NCT01096316|Secondary|Quality of Depression Care Indicators|Intervention impact on quality of depression care indicators and satisfaction with depression care. Number of participants receiving 4 or more mental health visits are reported. Receiving 4 or more mental health visits has previously been used in depression randomized control trials as a measure of the quality of depression treatment received by a patient|12 months||||participants|||Number
1420250|NCT01096316|Primary|Functional Outcome|Impact of the intervention on functional outcomes of patients. Functional impairment was measured using the Sheehan Disability Scale. The Sheehan disability scale is the average of 3 items assessing impairment in social, work and family responsibilities. Each item is rated 0 (no impairment) to 10 (totally impaired) and the 3 ratings are averaged for the Sheehan disability scale reported below.|12 months||||units on a scale||Standard Deviation|Mean
1420251|NCT01096316|Primary|Depression Treatment Outcome|Impact of the intervention on depression treatment outcomes, including change in depressive symptoms and treatment response. In particular, the depression scale from the Hopkins Symptom Checklist 20 (SCL-20) was used to assess depression severity at the assessments. The SCL-20 ranges from 0 (no depression) to 4 (severe depression),|12 months||||units on a scale||Standard Deviation|Mean
1420252|NCT01096186|Secondary|Patient Global Impression (PGI)|"Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale.~Patient Global Impression 0-7 – higher value indicates increased improvement from study start"|9 months|All enrolled subjects with available data|||units on a scale||Standard Deviation|Mean
1420253|NCT01096186|Secondary|Total UPDRS Parts I-IV|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient.~Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data|||units on a scale||Standard Deviation|Mean
1420254|NCT01096186|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study.~Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|9 months|All enrolled subjects with available data|||units on a scale||Standard Deviation|Mean
1420255|NCT01096056|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was event assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1420256|NCT01096056|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated-Diseases (pIMDs)|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1430680|NCT01004354|Secondary|HDL-cholesterol at Baseline and Post-treatment||Baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
1420257|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.|Day 0 up to Month 7|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1420258|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1420259|NCT01096056|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1420260|NCT01096056|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1420261|NCT01096056|Secondary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1420262|NCT01096056|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Subjects|||Number
1420263|NCT01096056|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR)|GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||fold increase||95% Confidence Interval|Geometric Mean
1420264|NCT01096056|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Subjects|||Number
1420265|NCT01096056|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Subjects|||Number
1420266|NCT01096056|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Subjects|||Number
1420267|NCT01096056|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.|At Day 0 and Day 42|The immunogenicity analysis was based on the Total Vaccinated cohort which included all vaccinated subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1420607|NCT01092910|Primary|Word Recognition Score Improvement|Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition|4 Months Post Activation||||improvement in % correct||Standard Error|Mean
1420268|NCT01096056|Primary|Number of Subjects Reporting Fever Grade 2 or Higher|Fever grade greater than or equal to 2 i.e. ≥2 was defined as axillary temperature >38 degree centigrade (°C).|Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1420269|NCT01096017|Secondary|Time to Change More Than or Equal to 15% (Time to Onset Response) Within 4 Hours After Drug Inhalation|Time to change more than or equal to 15% (time to onset response) within 4 hours after drug inhalation|At two visits during a maximum of 15 days||||Minutes||Standard Deviation|Mean
1420270|NCT01096017|Secondary|Number of Patients With % Change in FEV1 (Forced Expiratory Volume in 1 Second) >15% Within 4 Hours After Drug Inhalation|Number of patients with % change in FEV1 >15% within 4 hours after drug inhalation.|At two visits during a maximum of 15 days||||Participants|||Number
1420271|NCT01096017|Secondary|Time to Peak FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|Time to peak measurement of FEV1 (min)|At two visits during a maximum of 15 days||||Minutes||Full Range|Median
1420272|NCT01096017|Secondary|Maximum % Change in FEV1 (Forced Expiratory Volume in 1 Second) Within 4 Hours After Drug Inhalation|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percent change||Full Range|Geometric Mean
1420273|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 240 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
1420274|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 180 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
1420275|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 120 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
1420276|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 60 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
1420277|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
1420278|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
1420279|NCT01096017|Secondary|FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose|percent of pre-dose (ratio)|At two visits during a maximum of 15 days||||Percentage of Pre-Dose FEV1||Full Range|Geometric Mean
1420280|NCT01096017|Primary|FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation|FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation|At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.||||milliLiters x minutes||Full Range|Geometric Mean
1420281|NCT01095978|Secondary|Termination of Treatment|The number of participants who discontinued treatment is summarized.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
1420282|NCT01095978|Secondary|Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)|Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.|Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
1420283|NCT01095978|Secondary|Adverse Effects|The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
1420284|NCT01095978|Primary|Therapeutic Response|Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.|Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
1420285|NCT01095978|Primary|Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)|Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.|||Participants|||Number
1420286|NCT01095978|Primary|Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia|Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.|Visit 1 (Initial visit)|The per-protocol population was analyzed.|||Participants|||Number
1420287|NCT01095978|Primary|Auscultation Findings|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
1420608|NCT01092910|Primary|SRT Improvement|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|10 Months Post-Activation||||dB improvement||Standard Error|Mean
1420288|NCT01095978|Primary|Dyspnoea|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
1420289|NCT01095978|Primary|Cough and Its Character|Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed.|||Participants|||Number
1420290|NCT01095978|Primary|Body Temperature|Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.|Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)|The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1.|||Participants|||Number
1420291|NCT01095887|Primary|Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant||3 months after kidney transplant surgery||||participants|||Number
1420292|NCT01095835|Other Pre-specified|Percentage of Participants With Loss of Hepatitis B Surface Antigen (HbsAg) and Hepatitis B Surface Antibodies (Anti-HBs) Seroconversion|This outcome measure presents percentage of participants with a combined response of HBsAg < 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420293|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Below Limit of Quantification|HBV-DNA limit < 6 IU/mL was defined as below quantification.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420294|NCT01095835|Other Pre-specified|Percentage of Participants With HBV-DNA Lowering to <3,400 IU/mL and to < 2,000 IU/mL||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420295|NCT01095835|Other Pre-specified|Percentage of Participants With ALT Normalization||At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420296|NCT01095835|Secondary|Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy|Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.|At the end of the treatment period at Week 96|The ITT population for arm PEG-IFN+LAM96 included all participants randomized to PEG-IFN+LAM96 who received at least one dose of study medication.|||percentage of participants|||Number
1420297|NCT01095835|Secondary|Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment||At the end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication. Baseline values are included for those participants for whom a baseline value was measured. Change from baseline values includes only those participants with both a baseline value and a value for the summarized time period.|||IU/mL||Standard Deviation|Mean
1420298|NCT01095835|Secondary|Percentage of Participants Achieving Histological Response|Histological response was defined as an improvement by >/= 2 in the Necroinflammatory Grading and/or by an improvement by >/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420299|NCT01095835|Secondary|Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL|Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off <2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420300|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.|At the end of 24 weeks of follow-up at Week 120|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420301|NCT01095835|Secondary|Percentage of Participants Achieving the Combined Response at the End of Treatment|Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to <20,000 copies/mL (<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.|At end of treatment at Week 48 or 96 depending on the study arm|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420302|NCT01095835|Primary|Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period|Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to <20,000 copies/mL (<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.|At the end of the 48-week follow-up period at Week 144|The ITT population included all participants randomized who received at least one dose of study medication.|||percentage of participants|||Number
1420303|NCT01095796|Secondary|The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48||Week 48|ITT Analysis Set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).|||percentage of participants|||Number
1420304|NCT01095796|Secondary|The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192|Change = value of the relevant time point minus the baseline value|Baseline; Weeks 48, 96, 144, and 192|ITT Analysis Set. The missing = excluded (M = E) method was used in which all participants with missing data were excluded from analysis.|||cells/µL||Standard Deviation|Mean
1420305|NCT01095796|Secondary|The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm||Week 48|ITT Analysis Set|||percentage of participants|||Number
1420306|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192||Week 192|Week 192 Modified Intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.|||percentage of participants|||Number
1420307|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144||Week 144|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1420308|NCT01095796|Secondary|The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96||Week 96|ITT Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1420309|NCT01095796|Primary|The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48||Week 48|Intent-to-treat (ITT) Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
1420310|NCT01095757|Primary|Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg||Within the first 4 days following the first dose of Plerixafor||||participants|||Number
1420311|NCT01095757|Secondary|Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)||Within the first 4 days following the first dose of Plerixafor||||days||Standard Deviation|Mean
1420312|NCT01095757|Primary|Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis||Within the first 4 days following the first dose of Plerixafor||||participants|||Number
1420313|NCT01095666|Secondary|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Percentage of participants were estimated by modified logistic regression model, adjusted for baseline HbA1c.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1C values at Week 24 (LOCF)|||Percentage of Participants|||Number
1420314|NCT01095666|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
1420609|NCT01092910|Primary|SRT Improvement|Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition|4 Months Post Activation||||dB improvement||Standard Error|Mean
1420315|NCT01095666|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PMG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PMG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1420316|NCT01095666|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1420317|NCT01095666|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
1420318|NCT01095653|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)|||Percentage of participants||Standard Error|Mean
1420319|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)|||kg||Standard Error|Mean
1420320|NCT01095653|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PLMG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1420321|NCT01095653|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])|Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)|||mg/dL||Standard Error|Mean
1420322|NCT01095653|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)|||% of hemoglobin||Standard Error|Mean
1420323|NCT01095510|Secondary|Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations|Data was not reported due to change in planned analysis.|Pre-dose, 2, 4, 8 hours post dose on Day 1; Day 2, 3, 5, 8|No participant agreed to obtain pharmacokinetic (PK) blood sampling for antigenic and functional C1 INH levels. Hence, it was planned not to be analyzed.||||||
1420324|NCT01095510|Secondary|Time to Complete Resolution of the Attack||Within 1 week following treatment|ITT-E population.|||hours||Full Range|Median
1420325|NCT01095510|Secondary|Time to Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|ITT-E population|||hours||Full Range|Median
1420326|NCT01095510|Primary|Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom||Within 4 hours following treatment|Intent-to-treat efficacy (ITT-E) population included all participants with baseline and at least one post-infusion investigator assessment of the hereditary angioedema (HAE) attack.|||participants|||Number
1420327|NCT01095497|Secondary|Number of Subjects With C1INH Antibodies||18 days in each treatment period|||||||
1420328|NCT01095497|Secondary|C1 Inhibitor (C1INH) and C4 Levels||18 days in each treatment period|||||||
1420329|NCT01095497|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.||18 days in each treatment period||||Participants|||Number
1420330|NCT01095250|Secondary|Change in Immunosuppressive Medication Score From Baseline to Week 28|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
1420331|NCT01095250|Secondary|Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
1420332|NCT01095250|Secondary|Change From Baseline in Quality of Life/Patient Reported Outcome Assessments|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
1420333|NCT01095250|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
1420334|NCT01095250|Secondary|Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|||||||
1420335|NCT01095250|Primary|Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.|No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.|baseline to 28 weeks|The results of Study CAIN457C2303 did not meet the primary endpoint in non-infectious uveitis patients with Behçet’s disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.||||||
1420336|NCT01095094|Secondary|Grade 3-5 Toxicity as Assessed by NCI CTC v3.0|Number of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module.|at 6 months from start of treatment||||participants|||Number
1420337|NCT01095094|Primary|Progression-free Survival|Number of patients that remained disease free at 6 months from start of treatment.|At 6 months||||participants|||Number
1420338|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time|Descriptive statistics for AUC on Study Day 1 and Day 3 for prothrombin time, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis|||sec*hour||Standard Deviation|Mean
1420339|NCT01094886|Secondary|Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa|Descriptive statistics for Area Under the Curve (AUC) on Study Day 1 and Day 3 for Anti-Factor Xa, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis|||IU/ml*hour||Standard Deviation|Mean
1420340|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time|Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis|||sec||Standard Deviation|Mean
1420341|NCT01094886|Primary|Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)|Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3|Day 1, Day 3|ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis.|||IU/ml||Standard Deviation|Mean
1420342|NCT01094808|Secondary|Pain Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
1420343|NCT01094808|Secondary|Gas Sensation Rating Averaged Across 4 Distension Pressures (16, 24, 30, and 36 mg Hg)|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas. The values across the 4 distension pressures were averaged for this outcome measure.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
1420344|NCT01094808|Secondary|Sensation Ratings for Gas at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
1420345|NCT01094808|Secondary|Sensation Ratings for Pain at 16, 24, and 36 mm Hg Distension|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
1420346|NCT01094808|Secondary|Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
1420347|NCT01094808|Primary|Postprandial Motility Index Over 30 Minutes|The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1]|30 minutes after the meal||||log mm Hg||Standard Deviation|Mean
1420348|NCT01094808|Primary|Postprandial Colonic Tone [Reported] as the Symmetric Percent [Change]in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)||||Symmetric percentage change||Standard Deviation|Mean
1420349|NCT01094808|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|Approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
1420350|NCT01094808|Primary|Sensation Ratings for Pain and Gas at 30 mm Hg Distension Above Baseline Operating Pressure|The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
1420351|NCT01094808|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
1420352|NCT01094782|Primary|Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants|Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.|End of Week 4|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
1420525|NCT01093651|Secondary|Self-reported Symptoms|Cumulative number of self-reported symptoms based on the Division of AIDS Grading Scale for the Severity of Adult Adverse Events (0-4 scale where 0 is no new symptoms, 4 is serious adverse event or toxicity)|Monthly for 4 months|Cumulative frequency over 16 weeks of any self-reported symptoms on the DAIDS scale|||total number of self reported symptoms|||Number
1420353|NCT01094782|Primary|Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants|Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.|End of Week 2|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
1420354|NCT01094782|Primary|Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants|Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.|Start of Week 1|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
1420355|NCT01094782|Primary|Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants|Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject.|End of Week 4|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
1420356|NCT01094782|Primary|Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants|Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject.|End of Week 2|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
1420357|NCT01094782|Primary|Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants|Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule.|Start of Week 1|Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis.|||Degrees Celcius||Standard Deviation|Mean
1420358|NCT01094743|Secondary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|10 minutes after lens insertion at time of initial lens fitting||||units on a scale||Standard Deviation|Mean
1420359|NCT01094743|Primary|Subjective Assessment of Quality of Vision|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear||||units on a scale||Standard Deviation|Mean
1420360|NCT01094743|Secondary|Bulbar Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear||||eyes|eyes||Number
1420361|NCT01094743|Secondary|Limbal Redness|Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.|after 1 week of lens wear||||eyes|eyes||Number
1420362|NCT01094743|Primary|Subjective Assessment of Lens Comfort|Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|after 1 week of lens wear|Completed subjects|||units on a scale||Standard Deviation|Mean
1420363|NCT01094743|Primary|Visual Acuity Binocular|Snellen binocular visual acuity measurement|after 1 week of lens wear|All completed subjects|||participants|||Number
1420364|NCT01094743|Primary|Visual Acuity Monocular|Snellen monocular visual acuity measurement|after 1 week of lens wear|All completed subjects|||eyes|eyes||Number
1420365|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 14|The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.|||CLUE points||Standard Error|Mean
1420366|NCT01094730|Primary|Lens Front Surface Deposits at Day 14|Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.|Evaluated at Day 14|Analysis was conducted on subjects who successfully completed the study.|||dichtomized grading scale|Contact Lenses|Standard Deviation|Mean
1420526|NCT01093651|Secondary|Oral Glucose Tolerance|Area under the 75-gr oral glucose tolerance curve (AUCg) based on plasma glucose values measured at 0, 30, 60, 90, and 120 mins post-glucose challenge.|Baseline, week 8, week 16||||mg*min/mL||Standard Deviation|Mean
1420367|NCT01094730|Secondary|Subject Reported Overall Lens Comfort at Day 7|The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable /positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.|||CLUE points||Standard Error|Mean
1420368|NCT01094730|Primary|Lens Front Surface Deposits at Day 7|Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.|Evaluated at Day 7|Analysis was conducted on subjects who successfully completed the study.|||dichotomized grading scale|eyes|Standard Deviation|Mean
1420369|NCT01094704|Primary|Change in Average Mucociliary Clearance (0-90 Minutes) at 1 and 4 Hrs Post Dose (MCC4hr - MCCbaseline; MCC1hr - MCCbaseline)|Duration of action of hypertonic saline as determined by measurements of mucociliary clearance/cough clearance 4 hours post dose.|1-4 hours post-dose|ITT|||Absolute % change||Standard Deviation|Mean
1420370|NCT01094574|Secondary|Change in Arbitrary Perfusion Units From Baseline During Drug Infusion|Laser Doppler images were recorded at baseline and at 2 and 3 hours after starting the drug infusion to provide measurements of peripheral blood flow as an objective measure of inflammation. Blood flow was quantified by arbitrary perfusion units. Baseline measurements were subtracted from the average measurements obtained 2 and 3 hours after starting the drug infusion.|Laser doppler images were recorded at baseline and at 2 and 3 hours after starting the drug infusion||||relative flux||Standard Deviation|Mean
1420371|NCT01094574|Secondary|IL-12 (ng/mL) Change From Baseline During Infusion|IL-12 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420372|NCT01094574|Secondary|IL-10 (ng/mL) Change From Baseline During Infusion|IL-10 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420373|NCT01094574|Secondary|IL-8 (ng/mL) Change From Baseline During Infusion|IL-8 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420374|NCT01094574|Secondary|GMCSF (ng/mL) Change From Baseline During Infusion|GMCSF (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420375|NCT01094574|Secondary|IL-6 (ng/mL) Change From Baseline During Infusion|IL-6 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420527|NCT01093651|Secondary|RANTES; Serum Biomarkers of Immune Activation|serum Regulated on Activation, Normal T cell Expressed and Secreted concentration|Baseline, week 8, week 16|RANTES|||ng/mL||Standard Deviation|Mean
1420528|NCT01093651|Secondary|SDF1α; Serum Biomarkers of Immune Activation|serum stromal cell-derived factor-1α concentration|Baseline, week 8, week 16|SDF1α|||pg/mL||Standard Deviation|Mean
1420376|NCT01094574|Secondary|IL-2 (ng/mL) Change From Baseline During Infusion|IL-2 (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420377|NCT01094574|Secondary|IL-1β (ng/mL) Change From Baseline During Infusion|IL-1β (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420378|NCT01094574|Secondary|TNFα (ng/mL) Change From Baseline During Infusion|TNFα (ng/mL) was measured in interstitial fluid after collecting samples as follows: Microdialysis catheters (very small, custom-made, sterile, semi-permeable, micro-dialysis catheters) were placed after the 1st laser Doppler measurement. Two catheters were placed at an experimentally inflamed skin site on the left leg. A continuous infusion of sterile 1% albumin solution was started using a programmable pump set at a rate of 2.5µl/min. Samples were collected hourly throughout the remainder of the study day. Samples for analysis were collected before, and 2 and 3 hours after starting the drug infusion. Difference form baseline was calculated by subtracting the baseline concentration form the average concentration determined in samples collected during drug infusion.|Tissue samples were collected at baseline, and 2 and 3 hours after starting the drug infusion.||||ng/ml||Standard Deviation|Mean
1420379|NCT01094574|Primary|Change From Baseline in Mechanical Pain Threshold During Infusion in Inflamed Skin|A metal rod of 0.24 mm diameter mounted onto 10 different weights (1.0, 2.0, 4.1, 8.2,16.3, 20, 32.7,49.0, 65.3, and 81.3g) will be placed perpendicularly onto the skin. Starting with the lightest probe, consecutively heavier probes will be used until a subject reports pain. Subsequently, the same or the next lighter probe will be used if pain is reported for the preceding stimulus, or the same or the next heavier probe will be used if no pain is reported for the preceding stimulus.The procedure will be repeated until seven perceptional changes (painful/non-painful) are registered. Measurements for anti-hyperalgesia were taken at the sites of tissue injury. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||weight in grams||Standard Deviation|Mean
1420380|NCT01094574|Primary|Change From Baseline in Mechanical Pain Threshold During Infusion in Non-Inflamed Skin|A metal rod of 0.24 mm diameter mounted onto 10 different weights (1.0, 2.0, 4.1, 8.2,16.3, 20, 32.7,49.0, 65.3, and 81.3g) will be placed perpendicularly onto the skin. Starting with the lightest probe, consecutively heavier probes will be used until a subject reports pain. Subsequently, the same or the next lighter probe will be used if pain is reported for the preceding stimulus, or the same or the next heavier probe will be used if no pain is reported for the preceding stimulus.The procedure will be repeated until seven perceptional changes (painful/non-painful) are registered. Measurements for analgesia were taken at the sites of non-injured skin. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||weight in grams||Standard Deviation|Mean
1420381|NCT01094574|Primary|Change From Baseline in Heat Pain Threshold During Infusion in Inflamed Skin|Degrees Centigrade Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin on the upper thigh. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature. Measurements for anti-hyperalgesia were taken at the sites of tissue injury. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||degrees centigrade||Standard Deviation|Mean
1420382|NCT01094574|Primary|Change From Baseline in Heat Pain Threshold During Infusion in Non-Inflamed Skin|Degrees Centigrade Heat pain was induced with a thermal sensory analyzer (TSA-II, Medoc Advanced Medical Systems, Durham, North Carolina). A thermode was placed in contact with skin on the upper thigh. Starting at a comfortable temperature, the thermode temperature was increased at a measured rate. Study participants pushed a button of a hand-held device at the onset of pain at which point the thermode immediately reduced the temperature. Measurements for analgesia were taken at the sites of non-injured skin. Change form baseline was calculated by subtracting baseline values from the average values obtained 1 and 2 hours after starting the drug infusion.|Participants underwent the pain testing measures at baseline and at 1 and 2 hours after startingthe drug infusion.||||degree centigrade||Standard Deviation|Mean
1420383|NCT01094561|Secondary|The Positive Predictive Value of S-MRCP|"The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests.~Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Up to 1 year|||||||
1420529|NCT01093651|Secondary|Soluble TNFR2; Serum Biomarkers of Immune Activation|serum soluble tumor necrosis factor receptor-2 concentration|Baseline, week 8, week 16|sTNFR2|||pg/mL||Standard Deviation|Mean
1420384|NCT01094561|Primary|S-MRCP and S-EUS Concordance|"The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques.~Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report."|Day 1 and up to 30 days after S-MRCP|||||||
1420385|NCT01094548|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)|TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.|From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)|Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.|||participants|||Number
1420386|NCT01094548|Secondary|Time to Anti-tumor Therapy|Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||months||95% Confidence Interval|Median
1420387|NCT01094548|Secondary|Time to Progression (TTP)|Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: >25% increase in the level of serum monoclonal paraprotein (M-protein);>25% increase in the 24 h urinary light chain excretion; >25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death.|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||months||95% Confidence Interval|Median
1420388|NCT01094548|Secondary|Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR]|OCR (CR, or PR, or MR or NC or PD or NE) was defined per Blade Criteria. OCR rate (CR, or PR, or MR) was defined as the number of participants having experienced at least once a CR, PR, or MR, divided by the number of all participants. CR: negative immunofixation on serum and urine monoclonal paraprotein (M-protein), disappearance of any soft tissue plasmacytomas (STP), <=5% plasma cells in bone marrow (BM); PR: >=50% reduction in serum M-protein, plasma cells in BM, size of STP; >=90% reduction of urinary M-protein in 24 hours, no increase in size/number of the lytic bone lesions (LBL). MR: 25%-49% reduction in serum M-protein, plasma cells in BM aspirate in non-secretory myeloma participants, size of STP; 50%-89% reduction in 24 h urinary light chain reaction (LCR), and no increase in size/number of LBL. PD: >25% increase in the serum M-protein level, 24 hour urinary LCR. Increase in size of existing BL or STP, development of new BL or STP, or development of hypercalcemia|From the date of randomization up to Month 48|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||Percentage of participants|||Number
1420389|NCT01094548|Secondary|Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type|Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. “n” signifies number of participants evaluable for the particular HLA type, respectively.|||participants|||Number
1420530|NCT01093651|Primary|Plasma HIV Viremia (Viral Load)|Percentage of participants with plasma HIV RNA copy number less than 48 copies/mL|Monthly for 6 months||||percentage of participants below 48 c/mL|||Number
1420531|NCT01093651|Primary|CD4+ T-cell Count||Monthly for 4 months|CD4+ T-cell count|||cells/µL||Standard Deviation|Mean
1420390|NCT01094548|Secondary|Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response|Baseline immune response towards MUC1 was defined as an immune response towards BP25, MUC-A2 or MUC-A11 peptide stimulation which was present in at least one of the two baseline assessments; the specific immune responses at baseline were based on the averaged baseline values across the two baseline visits. Initial increase of MUC1-specific immune response was defined as an increase of MUC1-specific immune response during the primary treatment period (up to Week 9).|Baseline and Week 9|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||participants|||Number
1420391|NCT01094548|Primary|Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response|The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon [IFN] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell [PBMC]) with ratio to background >=2, and ratio of background-corrected value to baseline >=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t – Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS[t]=1), upon fulfilling the following criteria: Yt =>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t–1SEM vax,t > AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).|From the date of randomization up to Week 104|Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.|||participants|||Number
1420392|NCT01094522|Primary|Maximum Concentration of Methadone Including Its Metabolites (EDDP and EMDP)||0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs||||ng/mL||Full Range|Median
1420393|NCT01094522|Secondary|•Amount of Study Drug Administered During the 24-hour Dosing Period||24 hours||||mg||Full Range|Mean
1420394|NCT01094522|Secondary|•Pain Scores (FLACC) During the 24 Hours Study Period|"Average of hourly FLACC score for each subject over 24 hours was calculated, followed by median and full range for total subjects in each arm.~FLACC (Face, Leg, Activity, Cry, Consolability) score ranges from 0-10 with 0 representing no pain"|24 hours|Hourly FLACC score was calculated for 16 subjects in Methadone group and 19 subjects in morphine group|||units on a scale||Full Range|Median
1420395|NCT01094522|Primary|Maximum Concentration of Morphine Including Its Metabolites (Morphine-3-glucuronide and Morphine-6-glucuronide)||0, 15, 30 minutes, 1, 2, 4, 6 hrs, every 6 hrs up to 24 hrs||||ng/mL||Full Range|Median
1420396|NCT01094184|Secondary|Percentage of Participants By Karnofsky Performance Status Scale Scores|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Number Analyzed' signifies the number of participants who underwent Karnofsky Performance Status Scale Score assessment at specified time points for different arms, respectively. Data is not reported for Cycles 35, 41, 44 as no participant was evaluable at these time points.|||percentage of participants|||Number
1420397|NCT01094184|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.|Baseline up to disease progression (overall approximately 5 years and 9 months)|ITT analysis population|||months||95% Confidence Interval|Median
1420398|NCT01094184|Secondary|Percentage of Participants With Disease Progression|Disease progression was defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.|Baseline up to disease progression (overall approximately 5 years and 9 months)|ITT analysis population|||percentage of participants|||Number
1420399|NCT01094184|Secondary|Overall Survival|Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause. Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive.|Baseline up to death (overall approximately 5 years and 9 months)|ITT analysis population|||months||95% Confidence Interval|Median
1420400|NCT01094184|Secondary|Percentage of Participants Who Died Due to Any Cause||Baseline up to death (overall approximately 5 years and 9 months)|ITT analysis population|||percentage of participants|||Number
1420401|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at End of Study|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.|||mm||Standard Deviation|Mean
1420610|NCT01092832|Secondary|Time to Death||Baseline up to 1 month follow-up|No participants died within the safety reporting period, therefore time to death was not applicable.||||||
1420402|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 46|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 46 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.|||mm||Standard Deviation|Mean
1420403|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 44|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 44 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.|||mm||Standard Deviation|Mean
1420404|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 42|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 42 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.|||mm||Standard Deviation|Mean
1420405|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 40|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 40 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.|||mm||Standard Deviation|Mean
1420406|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 39|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 39 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.|||mm||Standard Deviation|Mean
1420407|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 37|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 37 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.|||mm||Standard Deviation|Mean
1420408|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 36|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 36 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.|||mm||Standard Deviation|Mean
1420409|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 32|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 32 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.|||mm||Standard Deviation|Mean
1420410|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 30|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 30 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.|||mm||Standard Deviation|Mean
1420411|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 29|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 29 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.|||mm||Standard Deviation|Mean
1420412|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 28|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 28 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.|||mm||Standard Deviation|Mean
1420413|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 27|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 27 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.|||mm||Standard Deviation|Mean
1420414|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 26|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 26 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.|||mm||Standard Deviation|Mean
1420415|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 25|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 25 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.|||mm||Standard Deviation|Mean
1420416|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 24|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 24 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.|||mm||Standard Deviation|Mean
1420417|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 23|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 23 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.|||mm||Standard Deviation|Mean
1420418|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 22|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 22 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.|||mm||Standard Deviation|Mean
1420419|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 21|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 21 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.|||mm||Standard Deviation|Mean
1420420|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 20|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 20 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.|||mm||Standard Deviation|Mean
1420421|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 18|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 18 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.|||mm||Standard Deviation|Mean
1420422|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 17|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 17 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.|||mm||Standard Deviation|Mean
1420423|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 16|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 16 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.|||mm||Standard Deviation|Mean
1420424|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 15|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 15 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.|||mm||Standard Deviation|Mean
1420425|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 14|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 14 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.|||mm||Standard Deviation|Mean
1420426|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 13|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 13 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.|||mm||Standard Deviation|Mean
1420427|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 12|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 12 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.|||mm||Standard Deviation|Mean
1420428|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 11|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 11 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.|||mm||Standard Deviation|Mean
1420429|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 10|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 10 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.|||mm||Standard Deviation|Mean
1420430|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 9|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 9 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.|||mm||Standard Deviation|Mean
1420431|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 8|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 8 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.|||mm||Standard Deviation|Mean
1420432|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 7|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 7 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.|||mm||Standard Deviation|Mean
1420433|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 6|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 6 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.|||mm||Standard Deviation|Mean
1420434|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 5|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 5 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.|||mm||Standard Deviation|Mean
1420435|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 4|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 4 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.|||mm||Standard Deviation|Mean
1420436|NCT01094184|Primary|Change From Baseline in EQ-5D-VAS Score at Cycle 3|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 3 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.|||mm||Standard Deviation|Mean
1420437|NCT01094184|Primary|Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Cycle 2 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.|||mm||Standard Deviation|Mean
1420438|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.|||units on a scale||Standard Deviation|Mean
1420439|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 46 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.|||units on a scale||Standard Deviation|Mean
1420440|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 44 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.|||units on a scale||Standard Deviation|Mean
1420441|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 42 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.|||units on a scale||Standard Deviation|Mean
1420442|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 40 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.|||units on a scale||Standard Deviation|Mean
1420443|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 39 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.|||units on a scale||Standard Deviation|Mean
1420444|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 37 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.|||units on a scale||Standard Deviation|Mean
1420445|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 36 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.|||units on a scale||Standard Deviation|Mean
1420611|NCT01092832|Secondary|All-Cause Mortality - Number of Participant Deaths||Day 28 and 1 Month Follow-up|Safety population|||participants|||Number
1420446|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 32 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.|||units on a scale||Standard Deviation|Mean
1420447|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 30 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.|||units on a scale||Standard Deviation|Mean
1420448|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 29 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.|||units on a scale||Standard Deviation|Mean
1420449|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 28 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.|||units on a scale||Standard Deviation|Mean
1420450|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 27 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.|||units on a scale||Standard Deviation|Mean
1420451|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 26 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.|||units on a scale||Standard Deviation|Mean
1420452|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 25 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.|||units on a scale||Standard Deviation|Mean
1420453|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 24 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.|||units on a scale||Standard Deviation|Mean
1420645|NCT01092637|Secondary|Number of Survivors With Cerebral Palsy|Number of participants diagnosed with Cerebral Palsy|7 years 3 months|Number of participants with cerebral palsy|||participants|||Number
1420454|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 23 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.|||units on a scale||Standard Deviation|Mean
1420455|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 22 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.|||units on a scale||Standard Deviation|Mean
1420456|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 21 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.|||units on a scale||Standard Deviation|Mean
1420457|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 20 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.|||units on a scale||Standard Deviation|Mean
1420458|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 18 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.|||units on a scale||Standard Deviation|Mean
1420459|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 17 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.|||units on a scale||Standard Deviation|Mean
1420460|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 16 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.|||units on a scale||Standard Deviation|Mean
1420461|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 15 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.|||units on a scale||Standard Deviation|Mean
1420945|NCT01089556|Other Pre-specified|Number of Participants Who Discontinued From Study Between Baseline and Week 8 Endpoint||Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).|||participants|||Number
1420462|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 14 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.|||units on a scale||Standard Deviation|Mean
1420463|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 13 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.|||units on a scale||Standard Deviation|Mean
1420464|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 12 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.|||units on a scale||Standard Deviation|Mean
1420465|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 11 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.|||units on a scale||Standard Deviation|Mean
1420466|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 10 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.|||units on a scale||Standard Deviation|Mean
1420467|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 9 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.|||units on a scale||Standard Deviation|Mean
1420468|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 8 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.|||units on a scale||Standard Deviation|Mean
1420469|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 7 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.|||units on a scale||Standard Deviation|Mean
1421276|NCT01086228|Secondary|Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1420470|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 6 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.|||units on a scale||Standard Deviation|Mean
1420471|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 5 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.|||units on a scale||Standard Deviation|Mean
1420472|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 4 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.|||units on a scale||Standard Deviation|Mean
1420473|NCT01094184|Primary|Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 3 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.|||units on a scale||Standard Deviation|Mean
1420474|NCT01094184|Primary|Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2|EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Cycle 2 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.|||units on a scale||Standard Deviation|Mean
1420475|NCT01094184|Primary|Change From Baseline in FACT-B Score at End of Study|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.|||units on a scale||Standard Deviation|Mean
1420476|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 46|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 46 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.|||units on a scale||Standard Deviation|Mean
1420477|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 44|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 44 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.|||units on a scale||Standard Deviation|Mean
1430681|NCT01004354|Secondary|Changes in Serum Levels of C-reactive Protein.||Baseline and 8 weeks|Data were not collected for this analyte.||||||
1420478|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 42|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 42 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.|||units on a scale||Standard Deviation|Mean
1420479|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 39|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 39 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.|||units on a scale||Standard Deviation|Mean
1420480|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 37|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 37 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.|||units on a scale||Standard Deviation|Mean
1420481|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 36|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 36 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.|||units on a scale||Standard Deviation|Mean
1420482|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 32|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 32 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.|||units on a scale||Standard Deviation|Mean
1420483|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 30|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 30 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.|||units on a scale||Standard Deviation|Mean
1420484|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 29|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 29 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.|||units on a scale||Standard Deviation|Mean
1420485|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 28|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 28 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.|||units on a scale||Standard Deviation|Mean
1420532|NCT01093625|Secondary|Comfortable Wearing Time|Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.|||Hours||95% Confidence Interval|Least Squares Mean
1430005|NCT01009931|Primary|Response Rate > 20% for 12-O-tetradecanoylphorbol-13- Acetate (TPA)+ Dexamethasone + Choline Magnesium Trisalicylate(Trilisate)||42 months|The study participant died before the study data collection completed.||||||
1420486|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 27|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 27 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.|||units on a scale||Standard Deviation|Mean
1420487|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 26|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 26 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.|||units on a scale||Standard Deviation|Mean
1420488|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 25|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 25 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.|||units on a scale||Standard Deviation|Mean
1420489|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 24|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 24 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.|||units on a scale||Standard Deviation|Mean
1420490|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 23|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 23 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.|||units on a scale||Standard Deviation|Mean
1420491|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 22|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 22 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.|||units on a scale||Standard Deviation|Mean
1420492|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 21|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 21 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.|||units on a scale||Standard Deviation|Mean
1420493|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 20|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 20 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.|||units on a scale||Standard Deviation|Mean
1420646|NCT01092637|Secondary|Number of Survivors Without Disability|IQ =>85, no neurological abnormalities, normal hearing, normal vision|7 years 3 months|Number of participants without disability. Two particpants in the cooled group and three in the non-cooled group could not be classified.|||participants|||Number
1420647|NCT01092637|Primary|Number of Survivors With an IQ > 84|IQ was measured using WPPSI III core tests|7 years 3 months|Children for whom IQ data at age 6-7 yr were available|||participants|||Number
1420494|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 18|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 18 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.|||units on a scale||Standard Deviation|Mean
1420495|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 17|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 17 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.|||units on a scale||Standard Deviation|Mean
1420496|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 16|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 16 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.|||units on a scale||Standard Deviation|Mean
1420497|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 15|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 15 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.|||units on a scale||Standard Deviation|Mean
1420498|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 14|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 14 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.|||units on a scale||Standard Deviation|Mean
1420499|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 13|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 13 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.|||units on a scale||Standard Deviation|Mean
1420500|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 12|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 12 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.|||units on a scale||Standard Deviation|Mean
1420501|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 11|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 11 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.|||units on a scale||Standard Deviation|Mean
1420648|NCT01092559|Primary|Adequacy of Device Design and Suitability of the Instructions for Use by the Clinician Using a Device Performance Evaluation||through Treatment Period||||participants|||Number
1420661|NCT01092442|Primary|Hemodynamic Performance|Peak Pulmonary Gradient Mean Pulmonary Gradient|Most Recent follow-up (average of 3-6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.|||mmHg||Standard Deviation|Mean
1420502|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 10|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 10 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.|||units on a scale||Standard Deviation|Mean
1420503|NCT01094184|Primary|Change From Baseline in FACT-B Score At Cycle 9|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 9 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.|||units on a scale||Standard Deviation|Mean
1420504|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 8|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 8 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.|||units on a scale||Standard Deviation|Mean
1420505|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 7|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 7 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.|||units on a scale||Standard Deviation|Mean
1420506|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 6|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 6 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.|||units on a scale||Standard Deviation|Mean
1420507|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 5|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 5 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.|||units on a scale||Standard Deviation|Mean
1420508|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 4|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 4 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.|||units on a scale||Standard Deviation|Mean
1420509|NCT01094184|Primary|Change From Baseline in FACT-B Score at Cycle 3|FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 3 (Cycle length=2 and 3 weeks)|ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.|||units on a scale||Standard Deviation|Mean
1420650|NCT01092546|Secondary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Pons as the Reference Region."|The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.|Post flutemetamol administration|"The correlation coefficient listed in the table is between SUVR-Pons and the percent area of Amyloid.~Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the Pons as the reference region."|||Correlation Coefficient of the site|||Number
1420510|NCT01094184|Primary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, Cycle 2 (Cycle length=2 and 3 weeks)|Intent-to-treat (ITT) analysis population included all participants who received at least 1 dose of all study medication (taxane and bevacizumab). 'Overall Number of Participants Analyzed'=participants who completed the questionnaire at Baseline; 'Number Analyzed'=participants who completed the questionnaire at Baseline and at specified time point.|||units on a scale||Standard Deviation|Mean
1420511|NCT01094171|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 – Month 4)||||Subjects|||Number
1420512|NCT01094171|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0 - 30) post vaccination period||||Subjects|||Number
1420513|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.|During the 4-day (Days 0 - 3) post vaccination period||||Subjects|||Number
1420514|NCT01094171|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)|During the 4-day (Days 0 - 3) post vaccination period||||Subjects|||Number
1420515|NCT01094119|Secondary|Proportion of Patients With Temperatures Above 36 Degree|Proportion of patients with esophogeal temperatures above 36 degree at the end of surgery|at the end of surgery|Enrolled patients|||Participants|||Count of Participants
1420516|NCT01094119|Primary|Time Weighted Average Core Temperature|Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation|from tracheal intubation to 3 hours after or tracheal extubation|Randomized patients.|||Degrees C||Standard Deviation|Mean
1420517|NCT01093976|Primary|Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score|The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28.|Subjects were followed for their duration of participation in the study (12-weeks)|Mean score reported below is the endpoint MGH-HPS score (at 12-weeks or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
1420518|NCT01093846|Primary|The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet’s Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1.|The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet’s patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .|62 weeks|||||||
1420519|NCT01093794|Primary|Cmax for Sitagliptin and Metformin|Cmax is the peak serum concentration of a therapeutic drug after administration; and is used to determine the rate and extent of drug absorption. Cmax is reported for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.|||ng/mL||Standard Deviation|Mean
1420520|NCT01093794|Primary|Area Under the Curve (AUC(0-t)) for Sitagliptin|AUC (0-t) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for sitagliptin 50 mg, metformin 500 mg and metformin 850 mg.|baseline through 72 hours postdose|Per-Protocol (PP) set: Participants who completed the study according to the protocol. One participant who discontinued after Treatment Period 1 was not included in the analysis.|||hr*ng/mL||Standard Deviation|Mean
1420521|NCT01093755|Primary|Change in Esophageal Inflammation Biomarker COX-2 Gene Expression|Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.|3 months, 6 months||||% of tubulin||Standard Deviation|Mean
1420522|NCT01093755|Primary|Change in Inflammation Biomarker Tissue PGE2 Level|Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay|3 months, 6 months||||nanograms/gram of tissue||Standard Deviation|Mean
1420523|NCT01093690|Secondary|Toxicities and Severity of Nausea and Vomiting||5 days after receiving chemotherapy|||||||
1420524|NCT01093690|Primary|Number of Patients Who Had Complete Response|number of patients who experience no emesis and need no rescue treatment in 5-day period|5 days after receiving chemotherapy|intention to treat|||participants|||Number
1420533|NCT01093625|Primary|Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire|The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.|1 Year|Subjects analyzed were those who were enrolled, randomized to the test group, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420534|NCT01093625|Primary|Corneal Neovascularization|New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420535|NCT01093625|Primary|Conjunctival Staining|Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420536|NCT01093625|Primary|Corneal Staining|Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||Efron Scale (0.1 Unit increments)||95% Confidence Interval|Least Squares Mean
1420537|NCT01093625|Primary|Limbal Hyperemia|Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420538|NCT01093625|Primary|Conjunctival Hyperemia|Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420539|NCT01093625|Primary|Papillary Conjunctivitis|Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.|1 Year|Subjects analyzed were those who were enrolled, randomized to the study groups, and completed the study.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420540|NCT01093599|Secondary|Changes in Self Reported Measures of Depression, Anxiety and Stress in Study Subjects vs Controls||6 months post quit day|||||||
1420541|NCT01093599|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects six months after the quit day.|6 months post quit day|intent to treat analysis|||participants|||Number
1420542|NCT01093534|Secondary|Percentage of Participants With Improvement or Deterioration in Patient Perception of Bladder Condition (PPBC)|"The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'.~Improvement: ≥ 1 point improvement compared to Baseline; Major Improvement: ≥ 2 point improvement compared to Baseline; Deterioration: ≥ 1 point deterioration compared to Baseline."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||percentage of participants|||Number
1420543|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urinary Nerve Growth Factor Normalized by Urine Creatinine|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.|||pg/µmol||Standard Deviation|Mean
1420544|NCT01093534|Secondary|Change From Baseline to Week 12 in Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr)|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline and Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF); LOCF was used.|||pg/µmol||Standard Deviation|Mean
1420563|NCT01093534|Secondary|Brain Derived Neurotrophic Factor Normalized by Urine Creatinine (uBDNF/Cr) at Week 12|Brain derived neurotrophic factor (uBDNF) and creatinine (Cr) were measured from urine samples by the central laboratories. uBDNF/Cr was derived by dividing uBDNF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Brain Derived Neurotrophic Factor (FAS_uBDNF): all randomized participants who received at least 1 dose of randomized study medication, who had given consent for additional analysis and who had an uBDNF/Cr measurement at baseline and on at least 1 visit thereafter. LOCF was used.|||pg/µmol||Standard Deviation|Mean
1420545|NCT01093534|Secondary|Change From Baseline in Health-Related Quality of Life (HRQL)|"Health-related quality of life was assessed by the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising of an 8-item symptom bother scale (see previous outcome measure) and 25 HRQL items comprising 4 subscales (concern, coping, social interaction and sleep) and a total HRQL score. Participants were asked how their overall bladder symptoms had affected their life in the past 4 weeks. Each of the 25 HRQL questions has a 6-point Likert scale response ranging from ‘none of the time’ (1) to ‘all of the time’ (6).~The HRQL subscale scores were calculated by summing the responses of the items within each subscale.The HRQL total score was calculated by adding the 4 HRQL subscale scores,. All scores were transformed to a scale from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline in HRQL score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420546|NCT01093534|Secondary|Change From Baseline in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the Overactive Bladder Symptom and Health-Related Quality of Life Questionnaire (OAB-q). The OAB-q is a patient-administered instrument comprising an 8-item symptom bother scale and 25 health-related quality of life items (see next outcome measure). In the symptom bother scale participants were asked how much they had been bothered by selected bladder symptoms during the past 4 weeks. Each question has a 6-point Likert scale response ranging from 'not at all' (1) to 'a very great deal' (6).~The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420547|NCT01093534|Secondary|Change From Baseline in EuroQoL 5-Dimension Questionnaire Visual Analog Scale|"The participants’ quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D) visual analog scale (VAS).~Health status is completed by the participant indicating their own health state today by drawing a line on a vertical scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420548|NCT01093534|Secondary|Percentage of Participants With Improvement and Worsening on the 5 Dimensions of the EQ-5D|"The participants’ quality of life was assessed using the EuroQoL 5 Dimension Questionnaire (EQ-5D). The EQ-5D is a standardized instrument for use as a measure of health outcome and is based on the following 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension participants were asked to select the statement which best described their health that day, from level 1 (indicating no problems) to 3 (indicating extreme problems/unable to perform).~Improvement was defined as a change from a state of being unable to perform or extreme problems at Baseline to no problems or to some or moderate problems at Week 12, and from some or moderate problems to no problems.~Worsening was defined as a change from no problems at Baseline to some or moderate problems or to a state of being unable to perform or extreme problems at Week 12, and from some or moderate problems to a state of being unable to perform or extreme problems."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data.|||percentage of participants|||Number
1420549|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Treatment Satisfaction|The treatment satisfaction visual analog scale (TS_VAS) asks patients to rate their satisfaction with treatment by placing a vertical mark on a 100 mm line where the endpoints are labeled ‘No, not at all’ on the left (score = 0) to ‘Yes, completely satisfied’ on the right (score = 100). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420550|NCT01093534|Secondary|Change From Baseline in Patient Assessment of Urgency Bother|"The participants’ perception and impression of bother associated with their condition were assessed using the Urgency Bother-Visual Analog Scale (UB-VAS). The participant was asked to place a vertical mark on a 100 mm line to indicate how much bother has urgency been for them in the past week, whereby ‘no bother at all’ is represented on the left end (score = 0) and ‘worst possible bother’ (score = 100) at the right end of the line.~A negative change from Baseline indicates improvement."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420551|NCT01093534|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420552|NCT01093534|Secondary|Change From Baseline to Week 12 in Total Urgency Score|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The total urgency score was calculated by adding all PPIUS scores over a 3-day period prior to the Baseline and Week 12 visits for each participant."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420564|NCT01093534|Secondary|Total Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Total (acidified) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Total uNGF/Cr was derived by dividing total uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data; LOCF was used.|||pg/µmol||Standard Deviation|Mean
1420553|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Level of Urgency|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The mean level of urgency was calculated by adding the PPIUS grade for all events (micturition or incontinence) and dividing by the number of episodes recorded in the diary over 3 days prior to the Baseline and Week 12 visits."|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||units on a scale||Standard Deviation|Mean
1420554|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 4 urgency incontinence events at Baseline and with available data; LOCF was used.|||urgency incontinence episodes||Standard Deviation|Mean
1420555|NCT01093534|Secondary|Change From Baseline in Mean Number of Urgency Incontinence Episodes With PPIUS Grade 3 or 4 Per 24 Hours|"An urgency incontinence episode is defined as any incontinence episode classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of grade 3 or 4 urgency incontinence episodes per 24 hours was calculated from the number of urgency incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full analysis set participants with grade 3 or 4 urgency incontinence events at Baseline and with available data; LOCF was used.|||urgency incontinence episodes||Standard Deviation|Mean
1420556|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was calculated from the number of incontinence episodes recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set participants with incontinence events at Baseline and with available data; LOCF was used.|||incontinence episodes||Standard Deviation|Mean
1420557|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Micturitions Per 24 Hours|"An urgency micturition is defined as any micturition classified by the participant as a grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~The average number of urgency micturitions per 24 hours was derived from the number of urgency micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits."|Baseline and Week 12|Full Analysis Set participants with urgency micturitions at Baseline and with available data; LOCF was used.|||urgency micturitions||Standard Deviation|Mean
1420558|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of micturitions recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||micturitions||Standard Deviation|Mean
1420559|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Urgency Events Per 24 Hours|"The intensity of urgency of each micturition (urination) and incontinence episode (any involuntary leakage of urine) was recorded by the participant in an electronic diary according to the Patient Perception of Intensity of Urgency Scale (PPIUS) as follows: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.~An urgency event is defined as any micturition or incontinence episode classified by the participant as a grade 3 or 4 on the PPIUS scale. The average number of urgency events per day is derived from the diary data completed by participants on the 3 days prior to the Baseline and Week 12 visits."|12 weeks|Full analysis set participants with events at Baseline and with available data; LOCF was used.|||urgency events||Standard Deviation|Mean
1420560|NCT01093534|Secondary|Change From Baseline to Week 12 in Mean Number of Events (Micturitions Plus Incontinence Episodes) Per 24 Hours|The average number of micturitions (urinations) and incontinence episodes (any involuntary leakage of urine) per day was derived from the number of events recorded by the participant in an electronic diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data; LOCF was used.|||events||Standard Deviation|Mean
1420561|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Baseline, Week 6 and Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0) participants with available data at each time point (indicated by n).|||pg/µmol||Standard Deviation|Mean
1420562|NCT01093534|Secondary|Change From Baseline to Week 6 and Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline, Week 6 and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT) participants with available data at each time point (indicated by n).|||mm||Standard Deviation|Mean
1420565|NCT01093534|Primary|Neutralized Urinary Nerve Growth Factor Normalized by Urine Creatinine at Week 12|Free (neutralized) urinary nerve growth factor (uNGF) and creatinine (Cr) were measured from urine samples by the central laboratories. Free (neutralized) uNGF/Cr was derived by dividing free (neutralized) uNGF concentrations [pg/mL] by the urine creatinine concentrations (µmol/mL) from the same participant.|Week 12|Full Analysis Set urinary Nerve Growth Factor subset (FAS_uNGF0): all randomized participants who received at least 1 dose of randomized study medication and who had an uNGF/Cr measurement at Baseline and on at least 1 visit thereafter, excluding participants with Baseline uNGF below or equal to the laboratory quantification limit. LOCF was used.|||pg/µmol||Standard Deviation|Mean
1420566|NCT01093534|Primary|Change From Baseline to Week 12 in Bladder Wall Thickness|Bladder wall thickness (BWT) measurements were obtained using transvaginal ultrasound. The BWT was derived as one mean value per image pooled over measurements of 3 locations (anterior wall, dome and trigone), and performed by 2 central readers and 1 adjudicator.|Baseline and Week 12|Full Analysis Set Bladder Wall Thickness (FAS_BWT): all randomized participants who received at least 1 dose of randomized study medication and who had a mean BWT measurement at Baseline. Analysis includes participants with available data; Last observation carried forward (LOCF) of post-baseline data was used for imputation of missing values.|||mm||Standard Deviation|Mean
1420567|NCT01093521|Primary|Number of Events When Study Drug Infusion Was Stopped Early|Tolerability as measured by adverse events of a 5 day continuous infusion of IV Gallium as assessed by stopping study drug infusion|6 days from starting dose||||Number of times study drug interupted|||Number
1420568|NCT01093521|Primary|Number of Serious Adverse Events|Safety as measured by serous adverse events|56 days from starting dose|ITT|||Serious Adverse Events|||Number
1420569|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 56|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 56|56 days from starting dose|All available specimens|||colony counts in millions per gm sputum||Standard Deviation|Mean
1420570|NCT01093521|Secondary|Change in Sputum P. Aeruginosa Density From Baseline to Day 15|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 15|15 days from starting dose||||colony counts in millions per gm sputum||Standard Deviation|Mean
1420571|NCT01093521|Secondary|Change in P. Aeruginosa Density From Baseline to Day 8|Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8|8 days from starting dose|All available specimens|||colony counts in millions per gm sputum||Standard Deviation|Mean
1420572|NCT01093521|Secondary|Change in Spirometry as Measured by FVC From Baseline to Day 8|Change from baseline in lung function assessed by FVC in liters after treatment with IV Ga at day 8|8 days from starting dose||||liters||Standard Deviation|Mean
1420573|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 56|Change in lung function as measured by FEV1 in liters from baseline to day 56|56 days from starting dose|all those subjects enrolled after the amendment to add a day 56 (ITT)|||liters||Standard Deviation|Mean
1420574|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 28|Change in lung function as measured by FEV1 in liters from baseline to day 28|28 days from starting dose||||liters||Standard Deviation|Mean
1420575|NCT01093521|Secondary|Change in Lung Function From Baseline to Day 15|Change in FEV1 in liters from baseline to day 15|15 days from starting dose||||liters||Standard Deviation|Mean
1420576|NCT01093521|Secondary|Change in Spirometry From Baseline to Day 8|Change in spirometry as measured by FEV1 in liters from baseline to day 8|8 days|ITT|||liters||Standard Deviation|Mean
1420577|NCT01093521|Primary|Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)|"To assess the summed area under the curves of a 5 day infusion of IV Ga from day 1 to day 28 at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~To assess the safety of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~Safety and tolerability of 5 days of treatment with IV administered gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day."|Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28||||ug*hr/mL||Standard Deviation|Mean
1420578|NCT01093482|Primary|All-cause Mortality|Mortality at discharge from intensive care unit|At day 28 after the beginning of mechanical ventilation||||Participants|||Count of Participants
1420579|NCT01093469|Primary|Investigator Global Assessment of Improvement|This measures the overall response to treatment and quantifies disease on a 6 point scale from “completely clear” to “worsening of disease”.0= Completely clear: except for possible residual hyperpigmentation, 1= Almost clear: very significant clearance (about 90%), 2 = Marked improvement: significant improvement (about 75%), 3= Moderate improvement: intermediate between slight and marked; representing about 50% improvements , 4= Slight improvement: some improvement (about 25%); however, significant disease remaining, 5 = No change from baseline, 6 = Worse|Day 21||||units on a scale||Standard Error|Median
1420580|NCT01093417|Secondary|Change in Serum 25-hydroxyvitamin D Concentration in Both Groups||Baseline and 12 weeks||||ng/mL||Inter-Quartile Range|Median
1420581|NCT01093417|Primary|Change in Endothelial Function|Endothelial function measured by flow mediated brachial artery dilation|Baseline and 12 weeks||||percent change in endothelial function||Inter-Quartile Range|Median
1420582|NCT01093222|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1420601|NCT01092910|Primary|SADEs|The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements|10 Months Post-Activation|Includes all events, cumulatively, from enrollment through 10-month followup|||events|||Number
1420602|NCT01092910|Secondary|Esteem Questionnaire|To gain subject feedback and comments on the use of the Esteem System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem Questionnaire.|4 and 10 Months Post Activatio-|||||||
1420603|NCT01092910|Secondary|APHAB|To assess whether the Esteem System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB results|4 and 10 Months Post-Activation|||||||
1420583|NCT01093222|Secondary|Objective Response|Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|Eligible patients who began protocol therapy|||percentage of participants||95% Confidence Interval|Number
1420584|NCT01093222|Primary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy|||months||95% Confidence Interval|Median
1420585|NCT01093222|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible patients who began protocol therapy|||months||95% Confidence Interval|Median
1420586|NCT01093183|Secondary|Overall Survival||Up to 4 years||||months||95% Confidence Interval|Median
1420587|NCT01093183|Secondary|Proportion of Patients Achieving CR||At 4 months||||Participants|||Count of Participants
1420588|NCT01093183|Secondary|Anti-tumor Activity as Assessed by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD)|As measured by Response Evaluation Criteria In Solid Tumors (RECIST version 1.1), in which CR is defined as disappearance of target lesions and a partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter of target lesions. PD is defined as 20% increase over smallest sum on study (including baseline if that is smallest) and at least 5 mm increase or new lesions. SD is defined as not enough response to be PR and not enough progression to be PD.|Up to 4 months|Of the 22 subjects evaluable, three patients did not complete 2 cycles of therapy to reassess or response evaluation.|||Participants|||Count of Participants
1420589|NCT01093183|Secondary|Number of Patients Achieving Objective PSA Response (50% Decrease in PSA Levels Sustained for at Least 4 Weeks) as Defined by PSA Working Group Criteria||4 weeks||||Participants|||Count of Participants
1420590|NCT01093183|Primary|Maximum Tolerated Dose of Lenalidomide Administered in Combination With Oral Cyclophosphamide (Phase I)|Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.|28 days||||mg|||Number
1420591|NCT01093027|Secondary|Tremor Rating Scale|Arm tremor severity was rated on a scale from 0=None to 4=Severe during each of four conditions: arm outstretched, hand close to mouth and arm abducted, performing a finger to nose maneuver, and holding a mug. The Tremor Rating Scale score was the mean of the scores for the four conditions, and ranged from a score of 0=None to 4=Severe.|After 10 minutes of limb cooling treatment.||||units on a scale||Standard Deviation|Mean
1420592|NCT01093027|Primary|Tremor Amplitude|Average tremor amplitude during the Outstretched, Abducted, Nose, and Mug conditions of the Tremor Rating Scale test.|After 10 minutes of limb cooling treatment.||||cm/s^2||Standard Deviation|Mean
1420593|NCT01093014|Primary|Skeletal Muscle Gene Expression: PPARGC1A|Messenger ribonucleic acid (mRNA) expression fold-change for peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PPARGC1A). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.|||fold-change||Standard Deviation|Mean
1420594|NCT01093014|Primary|Skeletal Muscle Gene Regulation: MSTN|Messenger ribonucleic acid (mRNA) expression fold-change for myostatin (MSTN). Fold change: post-intervention expression / pre-intervention expression. Values greater than 1.0 indicate up-regulation. Values less than 1.0 indicate down-regulation.|up to 1 year|Only a subset of Arm 1 and Arm 3 participants underwent biopsy: we achieved statistical power with these subsets and further biopsies were not warranted.|||fold-change||Standard Deviation|Mean
1420595|NCT01093014|Primary|LF Muscle Force|Muscle force evoked during low-force muscle stimulation|up to 1 year||||N (newtons)||Standard Deviation|Mean
1420596|NCT01093014|Primary|HF Muscle Force|Muscle force evoked during high-force muscle stimulation|up to 1 year||||Newtons (N)||Standard Deviation|Mean
1420597|NCT01092923|Primary|PA t/PA0 Sevo (End Tidal Partial Pressure of Sevoflurane), t=Time (Minutes)|Rate of fall in the end-tidal partial pressure of sevoflurane relative to baseline at 2 minutes (PA2/PA0 sevo) and 5 minutes (PA5/PA0 sevo)|Baseline, 2 minutes, and 5 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.|||ratio||Standard Deviation|Mean
1420598|NCT01092923|Secondary|Time to Eye Opening|The time to eye opening to command after cessation of inhalational anaesthetic administration|20 Minutes||||Minutes||Standard Deviation|Mean
1420599|NCT01092923|Primary|Pa t/Pa0 Sevo (Arterial Partial Pressure of Sevoflurane), t=Time(Minutes)|Rate of fall in the arterial partial pressure of sevoflurane relative to baseline at 2 minutes (Pa 2/Pa0 Sevo), 5 minutes (Pa 5/Pa0 Sevo, and 30 minutes (Pa 30/Pa0 Sevo)|Baseline, 2 minutes, 5 minutes, and 30 minutes after emergence|based on data collected during previous pilot study investigating the magnitude of the second gas effect on sevoflurane partial pressures after anaesthesia induction, we expected an effect of roughly similar magnitude would be present during elimination of nitrous oxide.|||ratio||Standard Deviation|Mean
1420600|NCT01092910|Primary|Assessment of Cochlear Function|Comparison of the bone conduction threshold with forehead placement at the 4 month post-activation follow-up compared to the pre-implant bone conduction threshold.|4 and 10 Months Post-Activation|10-month results for difference in BC PTA (pre-implant minus post-Esteem) are shown|||dB difference||Standard Error|Mean
1443751|NCT00906204|Secondary|Graft Survival|Kaplan-Meier estimates of graft survival probability for 12 months after transplantation|12 months post-transplantation||||participants|||Number
1420612|NCT01092832|Secondary|Percentage of Participants With a Global Response of Success at End of Treatment (EOT)|Global response was determined programmatically based on investigator assessment of clinical and microbiological response. Global response of success was defined as clinical cure or improvement AND microbiological eradication or presumed eradication. Exact 95 percent (%) confidence interval for binomial proportions using Clopper-Pearson method.|EOT (from 7 to 42 days of treatment)|Modified Intent-to-Treat (MITT) Population: all participants who received at least 1 dose of study medication and who have confirmed ICC, EC or participants with EC who do not have confirmation of EC by esophagoscopy, but who had at least confirmation of oropharyngeal candidiasis.|||percentage of participants||95% Confidence Interval|Number
1420613|NCT01092832|Primary|Percentage of Participants With Adverse Events - Overall Summary|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, who discontinued due to AEs, or who had dose redued or temporarily discontinued due to AEs.|Baseline up to 1 month follow-up|Safety population|||percentage of participants|||Number
1420614|NCT01092780|Secondary|Mean Score on SDLP Driving Test for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Meters||90% Confidence Interval|Least Squares Mean
1420615|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking Modafinil Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Minutes||95% Confidence Interval|Least Squares Mean
1420616|NCT01092780|Secondary|Mean Sleep Latency Score on the MWT for Participants Taking MK-7288 Versus Modafinil|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Minutes||95% Confidence Interval|Least Squares Mean
1420617|NCT01092780|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.|Up to 36 days|All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1420618|NCT01092780|Primary|Mean Score on Standard Deviation of Lane Position (SDLP) Driving Test for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. Driving performance was measured by the SDLP test which is a 45-minute driving simulation country vigilance test and was performed by participants at 10:00, 12:00 and 14:00. An LS mean of the 2 SDLP driving test results performed at 10:00 and 14:00 was calculated. A lower value is considered a better outcome.|2, 4 and 6 hours post dose|The PP population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Meters||95% Confidence Interval|Least Squares Mean
1420619|NCT01092780|Primary|Mean Sleep Latency Score on the Maintenance of Wakefulness Test (MWT) for Participants Taking MK-7288 Versus Placebo|Study drug was administered at 08:00. MWT, an objective measure of the participant's ability to maintain wakefulness, was administered at 09:00, 11:00, 13:00 and 15:00. A least squares (LS) mean of the 4 MWTs performed at 09:00, 11:00, 13:00 and 15:00 was calculated. Latency for each MWT is defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep has been observed according to these rules, then the latency is defined as 30 minutes. A higher MWT value is considered a better outcome.|1, 3, 5 and 7 hours post dose|The Per-Protocol (PP) population consisted of all participants who were compliant with the protocol and had available data from at least one treatment period.|||Minutes||95% Confidence Interval|Least Squares Mean
1420620|NCT01092767|Primary|All-cause Mortality Within 30-days of the Index Procedure||30 days||||participants|||Number
1420621|NCT01092728|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to date of first evidence of progression or the date of last follow-up for patients who do not progress.|Evaluated every 2 cycles (8 weeks) until disease progression or last follow-up, up to two years|None of the participants in the Resectable arm were evaluable, and one participant in the second Unresectable arm was inevaluable due to early departure from study.|||Weeks||Full Range|Median
1420649|NCT01092559|Primary|Incidence and Severity of Treatment Emergent Adverse Events; Unanticipated Adverse Device Effects and Changes From Baseline to End-of-study in Clinical Lab Parameters and Vital Signs.|"Adverse Event Severity [through Day 30 Follow-Up Period]~Unanticipated Device Effects: any system malfunction, damage or NO2 threshold monitor alarms [through discharge from Treatment Period]~Laboratory Tests: Hematology (CBC with differential), Chemistry (glucose, BUN, creatinine, sodium, potassium, carbon dioxide, creatinine kinase), Activated Clotting Test or Prothrombin Time, arterial blood gas, and methemoglobin.~[through discharge from Treatment Period]~Vital Signs: pulse, blood pressure, respiratory rate [through discharge from Treatment Period]"|through Day 30 Follow-up Period||||participants|||Number
1420622|NCT01092728|Primary|Biologic Response Evaluation of Tumors With and Without Resectable Tumors|"Biologic response defined as either (complete or partial) metabolic tumor response after 7 days dasatinib treatment by positron emission tomography (PET) scan, >/= 25% decrease in Fluorodeoxyglucose (FDG) activity on PET without >15% increase in tumoral Ki-67 expression or >/=25% decrease in tumoral Ki-67 expression without >15% increase in FDG activity on PET scan. Complete Metabolic Response (CMR): FDG-avidity all lesions reduced to background FDG-avidity level. Partial Metabolic Response (PMR): >/=25% decrease in FDG-avidity as represented by change in mean Standardized Uptake Values (SUV) max. SUVmax measured by drawing region of interest slightly outside each lesion corresponding to those on CT image & adjusted for body weight. Measureable disease by PET scan defined as lesions that can be determined to have FDG-avidity of SUVmax of 3 and 2 x background.~PR or CR confirmatory disease assessment performed >4 weeks (28 days) after criteria for response first met."|Assessment at 7 Days with confirmatory disease assessment performed no less than 4 weeks (28 days) afterwards|Of 4 participants in first arm, none were evaluable for response (1 inevaluable, 2 withdrawals, 1 disease progression); and of the second arm, one was inevaluable (withdrawal).|||participants|||Number
1420623|NCT01092702|Primary|Biochemically Confirmed Abstinence From Smoking|The primary endpoint of this trial is biochemically confirmed 7-day point prevalence smoking abstinence at the end of the medication phase (week 12). Self-reported abstinence from smoking (not even a puff) over the last 7-days will be considered biochemically confirmed by an expired air CO of <8 ppm. Subjects who discontinue the study or have a missed visit for any reason will be classified as smoking for that visit.|12 weeks from start of medication||||participants|||Number
1420624|NCT01092663|Secondary|Postprandial Glucagon (AUC)|To evaluate the effects of treatment on postprandial glucagon (AUC)|Baseline and 12 weeks||||picograms (pg)/milliter (ml) x min||Standard Deviation|Mean
1420625|NCT01092663|Secondary|Postprandial Total GIP (AUC)|To evaluate the effects of treatment on postprandial total GIP (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
1420626|NCT01092663|Secondary|Postprandial Active GLP-1 (AUC)|To evaluate the effects of treatments on postprandial active GLP-1 (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
1420627|NCT01092663|Secondary|Postprandial C-peptide (AUC)|To evaluate the effect of treatments on postprandial C-peptide (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
1420628|NCT01092663|Secondary|Postprandial Insulin (AUC)|To evaluate the effect of treatments on postprandial insulin (AUC)|Baseline and 12 weeks||||pmol/l x min||Standard Deviation|Mean
1420629|NCT01092663|Secondary|Fasting Insulin|To evaluate the effect of treatments on fasting insulin concentrations|Baseline and 12 weeks||||pmol/L||Standard Deviation|Mean
1420630|NCT01092663|Primary|Postprandial Glucose (AUC)|Comparison between baseline and 12 weeks values of postrandial glucose (AUC).|Baseline and 12 weeks||||millimoles (mmol)/l x min||Standard Deviation|Mean
1420631|NCT01092663|Primary|Whole-body Glycolytic Disposal of Oral Glucose|Change in baseline in whole-body glycolytic disposal of oral glucose after 12 weeks of colesevelam alone or colesevelam plus glucose treatments|baseline and 12 weeks||||Percent of Load||Standard Deviation|Mean
1420632|NCT01092663|Primary|Postprandial Rate of Total Glucose Disposal Area Under the Curve (AUC)|"Change from baseline in postprandial rate of total glucose disposal (AUC) after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments~AUC was calculated by the trapezoid method using all results measured between 0 and 300 min during the meal tolerance test."|baseline and 12 weeks||||umol per kg per min||Standard Deviation|Mean
1420633|NCT01092663|Primary|Postprandial Endogenous Glucose Production|"Change from baseline in postprandial endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments~Mean value was calculated using all results measured between 10 and 300 min post meal."|baseline and 12 weeks||||umol per kg per min||Standard Deviation|Mean
1420634|NCT01092663|Primary|Appearance Rate of Oral Glucose|Change from baseline in appearance rate of oral glucose after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments|baseline and 12 weeks||||umol per kg per min||Standard Deviation|Mean
1420635|NCT01092663|Primary|Fasting Plasma Glucose Clearance|Change from baseline in fasting plasma glucose clearance after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatments.|baseline and 12 weeks||||ml per kg FFM per minute (min)||Standard Deviation|Mean
1420636|NCT01092663|Primary|Fasting Glycogenolysis|Change from baseline in fasting glycogenolysis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks||||umol per kg Fat-Free Mass (FFM) per min||Standard Deviation|Mean
1420637|NCT01092663|Primary|Fasting Gluconeogenesis|Change from baseline in fasting gluconeogenesis after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks||||umol per kilogram (kg) FFM per min||Standard Deviation|Mean
1420638|NCT01092663|Primary|Fasting Endogenous Glucose Production|Change from baseline in fasting endogenous glucose production after 12 weeks of colesevelam alone or colesevelam plus sitagliptin treatment|baseline and 12 weeks||||micromoles (umol) per kg FFM per min||Standard Deviation|Mean
1420639|NCT01092663|Secondary|Fasting Plasma Total Glucose-dependent Insulinotropic Peptide (GIP)|To evaluate the effect of treatments on plasma Glucose-dependent Insulinotropic Peptide (GIP) concentrations.|Baseline and 12 weeks||||pmol/L||Standard Deviation|Mean
1420640|NCT01092663|Secondary|Fasting Active Plasma Glucagon Like-Peptide 1 (GLP-1)|To evaluate the effect of treatments on plasma GLP-1 concentrations.|Baseline and 12 weeks||||pmol/L||Standard Deviation|Mean
1420641|NCT01092663|Secondary|Fasting Plamsa Glucagon|To evaluate the effect of treatments on plasma glucagon concentrations.|Baseline and 12 weeks||||picograms (pg)/milliliter (ml)||Standard Deviation|Mean
1420642|NCT01092663|Primary|Fasting Plasma Glucose|Change from baseline in fasting plasma glucose concentrations after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments.|Baseline and 12 weeks||||millimoles (mmol)/Liter (L)||Standard Deviation|Mean
1420643|NCT01092663|Secondary|Fasting Plasma C-peptide|To evaluate the effect of treatments on plamsa C-peptide concentrations.|Baseline and 12 weeks||||picomoles (pmol)/Liter (L)||Standard Deviation|Mean
1420644|NCT01092663|Primary|Hemoglobin A1C|Change from baseline in hemoglobin A1C after 12 weeks of colesevelam or colesevelam plus sitagliptin treatments|Baseline and 12 weeks||||percentage||Standard Deviation|Mean
1420651|NCT01092546|Primary|"Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Cerebellum (CER) as the Reference Region."|The level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.|Post flutemetamol Injection|"The correlation coefficient listed in the table is between SUVR-CER and the percent area of Amyloid.~Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the cerebullum (CER) as the reference region."|||Correlation Coefficient of the Site|||Number
1420652|NCT01092507|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®)|"Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.~Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature > 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable."|Day 0 through Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population).|||Participants|||Number
1420653|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set)|||Titers||95% Confidence Interval|Geometric Mean
1420654|NCT01092507|Secondary|Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 up to 12 months post-vaccination|Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set)|||Participants|||Number
1420655|NCT01092507|Secondary|Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®)|Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Titers||95% Confidence Interval|Geometric Mean
1420656|NCT01092507|Secondary|Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination."|Day 28 post-vaccination|Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Participants|||Number
1420657|NCT01092507|Secondary|Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®)|"Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50.~Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12."|Day 28 post-vaccination|Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Participants|||Number
1420658|NCT01092507|Primary|Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®)|"Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50).~Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination."|Day 0 through Day 28 after vaccination|Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population)|||Participants|||Number
1420659|NCT01092442|Primary|Safety Assessment|"Evaluation of the following adverse events~Mortality (all cause and valve-related)~Reoperation/reintervention~Explant~Endocarditis~Structural valve deterioration (defined as >40 mmHg peak pulmonary gradient or >30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency)~Thrombosis~Thromboembolism (pulmonary embolism)~Non-structural dysfunction~Perivalvular leak~Bleeding~Hemolysis~Calcification"|Since Implant of the Valve to a Maximum of 13.0 years||||percentage of patients|||Number
1420660|NCT01092442|Primary|Hemodynamic Performance|Pulmonary Insufficiency Grade|Most Recent Follow-up (average of 4 to 6 years post implant)|The number of participants was limited to those participants with a hemodynamic measurement provided. Therefore, the total number in each group is less than the total participants in each group.|||participants|||Number
1420662|NCT01092416|Primary|Primary Efficacy Endpoint: Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.||||Percentage of procedures||95% Confidence Interval|Number
1420663|NCT01092416|Secondary|12-Month Freedom From Major Adverse Cardiac Events (MACE)|The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.|12 months|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 12 months.|||Percent probability of Freedom from MACE||95% Confidence Interval|Number
1420664|NCT01092416|Secondary|Severe Angiographic Complications|Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.|Baseline procedure, with a mean total procedure time of 52.5 minutes.||||Participants|||Number
1420665|NCT01092416|Secondary|Angiographic Success|Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.|Baseline procedure, with a mean total procedure time of 52.5 minutes.||||Percentage of procedures|||Number
1420666|NCT01092416|Primary|Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)|"OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of:~Cardiac death.~MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave.~TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure."|30 days|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.|||Percent probability of Freedom from MACE||95% Confidence Interval|Number
1420667|NCT01092364|Primary|Change in Body Weight||Baseline and 24 months|Intention to treat|||kg||Standard Deviation|Mean
1420668|NCT01092338|Primary|Efficacy of the Two Doses (4000 and 7000 IU/d)|Daily D3 supplementation will result in 25D >= to 32/ng/ml|12 weeks|Number of subjects with serum 25D concentration levels >= 32 ng/ml after 12 weeks of supplementation.|||participants|||Number
1420669|NCT01092338|Primary|Safety|Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml).|12 weeks|Number of subjects with elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (>160ng/ml)|||participants|||Number
1420670|NCT01091974|Secondary|Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .|The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue “now,” and fatigue at its “worst” and “usual” for the last 24 hours. The 11-point scales are bounded by 0 = “no fatigue” and 10 = “fatigue as bad as you can imagine.” Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = “does not interfere” and 10 = “interferes completely.” A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).|Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.|||units on a scale||Standard Error|Mean
1420671|NCT01091974|Primary|Change in Insomnia Severity Index From Baseline to Post-intervention|The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.|ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).||||units on a scale||Standard Error|Mean
1420672|NCT01091948|Secondary|Number of Intubation Attempts||from start of intubation to successfully intubated||||participants|||Number
1420673|NCT01091948|Secondary|Sore Throat Grade||On the first postoperative day|This outcome was not collected for 1 patient in each group.|||participants|||Number
1420674|NCT01091948|Secondary|Trace Bleeding|Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube|Right after intubation||||participants|||Number
1420675|NCT01091948|Secondary|Occurrence of Hypoxaemia|Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.|at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after||||participants|||Number
1420676|NCT01091948|Secondary|Successful Intubation on 1st Attempt||from start of first intubation to end of first intubation attempt||||participants|||Number
1420677|NCT01091948|Secondary|Intubation Difficulty Score|Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);|from start of intubation to successfully intubated||||units on a scale||Inter-Quartile Range|Median
1420678|NCT01091948|Primary|Time to Intubation (TTI) as Measured in Seconds|Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).|from start of intubation to successfully intubated up to 100 seconds||||seconds||Inter-Quartile Range|Median
1420679|NCT01091675|Primary|the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined|"BASDAI Bath Ankylosing Spondylitis Disease Activity Index, is the gold standard for measuring and evaluating disease activity in Ankylosing Spondylitis consists of a one through 10 scale which is used to answer 6 questions pertaining to the 5 major symptoms of AS.~BASDAI has been used to assess the efficacy of the treatment. Possible Patients were considerate respond to ASABIO criteria when presented a change of 2 in the BASDAI score range."|the ASAS response were evaluated at week 2 and 4 and after 6 months treatment|Patients with physician-diagnosed Ankylosing Spondylitis at 6 months before study start|||percentage of participants||95% Confidence Interval|Number
1420680|NCT01091662|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Double-blind: week to 18; Baseline: weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 54; Baseline: 54; Titration: 54; AED taper/conversion; 54; Monotherapy: 48 (ESL 1600 mg) Double-blind: 100; Baseline: 98; Titration: 100; AED taper/conversion; 100; Monotherapy: 88|||seizures in 28 days||Standard Deviation|Mean
1420681|NCT01091662|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population|||Percent of particiants|||Number
1420682|NCT01091662|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L.|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Week 0 to Week 18|ITT population|||percentage of participants|||Number
1420683|NCT01091662|Secondary|Proportion (%) of Subjects With Increase of Body Weight >= 7% From Baseline||18 Week Double-blind treatment period|ITT population|||percentage of participants|||Number
1420684|NCT01091662|Secondary|Change in Total Score of MADRS From Baseline in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, higher score indicates more severe|Week 0 to Week 18, baseline:day 0;end of AED taper/conversion period; end of week 8; end of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 7; Change from baseline to end of monotherapy period: 7 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 16; Change from baseline to end of monotherapy period: 18|||units on a scale||Standard Deviation|Mean
1420685|NCT01091662|Secondary|Change in Total Score in Montgomery-Asberg Depression Rating Scale (MADRS),From Baseline .|The total score of MADRS is defined as the sum of all individual item scores. From 0-60, high score indicates more severe|Week 0 to Week 18,baseline day 0; end of AED taper/conversion period; end of week 8; end of monotherapy period; end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 48; Change from baseline to end of monotherapy period: 54 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 88; Change from baseline to end of monotherapy period: 98|||units on a scale||Standard Deviation|Mean
1420686|NCT01091662|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, Baseline: Day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|Efficacy Population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period:50 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 85; Change from baseline to end of monotherapy period:96|||units on a scale||Standard Deviation|Mean
1420687|NCT01091662|Secondary|Proportion (%) of Subjects Reaching Each Exit Criteria|"The proportion (%) of subjects reaching each of the 5 exit criteria-1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.~5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|Week 1 to Week 18, (beginning of week 1 to end of week 18)|Efficacy population|||percentage of participants|||Number
1420688|NCT01091662|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double-blind weeks 1-18; baseline: weeks -8 to -1; Titration: weeks 1-2; AED taper/conversion; weeks 3-8; monotherapy weeks 9-18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
1420689|NCT01091662|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|18 weeks, Double-blind:weeks 1-18; Baseline: weeks -8to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy; weeks 9 to 18|Efficacy population (ESL 1200mg) Double-blind: 54; Titration: 54; AED taper/conversion:54; Monotherapy: 48 (ESL1600 mg) Double-blind:98; Titration: 98; AED taper/conversion: 98; Monotherapy: 87|||Percent change||Inter-Quartile Range|Median
1420690|NCT01091662|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|Efficacy population|||days||95% Confidence Interval|Median
1420691|NCT01091662|Secondary|Completion Rate During the 10 Weeks of Monotherapy (% of Subjects Entering the Monotherapy Period Who Complete).|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Week 8 through 18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
1420692|NCT01091662|Secondary|Completion Rate (% of Subjects Completing the 18 Weeks of Double-blind Treatment).|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|18 weeks|Efficacy population|||percentage of participants||95% Confidence Interval|Number
1420979|NCT01089517|Primary|Mean Change in Visual Acuity From Baseline at the Week 24 Visit|The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit|24 Weeks|Intent to Treat Population (last observation carried forward)|||ETDRS Letters||Standard Error|Mean
1420693|NCT01091662|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Percentage of participants that were Seizure-free during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Week 15 through 18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
1420694|NCT01091662|Secondary|Proportion (%) of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Week 9 through 18|Efficacy population|||percentage of participants||95% Confidence Interval|Number
1420695|NCT01091662|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|"Cumulative exit rate was defined as the proportion of subjects meeting at least one of the following five exit criteria over a 16-week study period (from start of AED taper/con. period (Wk 3) to end of double blind monotherapy period (Wk 18)).1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 week baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 week baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 week baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.~5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the investigator"|From beginning of Week 3 to end of Week 18|Efficacy population|||proportion of participants||95% Confidence Interval|Number
1420696|NCT01091519|Secondary|Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4|Participant’s response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5–point scale, participant was asked: “overall how satisfied are you with your over active bladder (OAB) medication?” 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2).|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||participants|||Number
1420697|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4|PPUS: single-item, self-administered validated questionnaire. Rated on a 3–point scale: participant was asked: “Which of the following would typically describe your experience when you have a desire to urinate?” 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change).|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||participants|||Number
1420698|NCT01091519|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4|"PPBC: single-item, self-administered validated questionnaire. Rated on a 6–point scale: participant was asked: “Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2)."|Baseline, Week 4, Month 4|FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||participants|||Number
1420699|NCT01091519|Primary|Percentage of Participants Satisfied With Treatment at Month 4|Participant’s response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: “overall, how satisfied are you with your OAB medication?” and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including “very satisfied” and “somewhat satisfied”) and dissatisfied (including “very dissatisfied”, “somewhat dissatisfied”, and “neither dissatisfied nor satisfied”).|Month 4|Full Analysis Set (FAS) included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1420700|NCT01091454|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 5 years||||months||95% Confidence Interval|Number
1420710|NCT01091428|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time form the date of the randomization to the date of death.|Up to data-cut off: 12 August 2014 (approximately 24 months)|mITT Population was defined as all participants who were randomized and received at least 1 dose of any study drug. For a participant that is alive, OS will be censored at the last known date.|||days||80% Confidence Interval|Median
1420992|NCT01089361|Secondary|Adverse Effects Attributable to Ketamine||7 days||||adverse events|||Number
1420701|NCT01091454|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|up to 5 years||||months||95% Confidence Interval|Median
1420702|NCT01091454|Secondary|6-month Progression-free Survival (6-mo PFS) Rate|6-month progression-free survival. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|At 6 months||||proportion of participants||95% Confidence Interval|Number
1420703|NCT01091454|Secondary|Duration of Response|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||months||95% Confidence Interval|Median
1420704|NCT01091454|Secondary|Confirmed Response Rate|A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years|Out of the total number of participants who completed the study and were evaluable for the primary endpoint and adverse events (as provided in the Participant Flow), only a subset of participants (Overall Number of Participants Analyzed specified above) were evaluable for the Confirmed Response Rate.|||percentage of confirmed responses||95% Confidence Interval|Number
1420705|NCT01091454|Primary|3-month Progression-free Survival (3-mo PFS) Rate|A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|3 months||||proportion of participants||95% Confidence Interval|Number
1420706|NCT01091428|Other Pre-specified|Banked Tumor Specimens for Candidate Markers of Response to Alisertib and Taxanes||Up to 24 Months|This Outcome Measure was originally registered as a Secondary but this Outcome Measure was Exploratory and no data was collected.||||||
1420707|NCT01091428|Secondary|Phase 2: Number of Participants With Clinically Significant Vital Sign Findings|Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.|First dose to 30 days past last dose (Up to 27 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1420708|NCT01091428|Secondary|Phase 2: Number of Participants With Clinically Significant Laboratory Values|Abnormal clinical laboratory values (serum chemistry, hematology and urinalysis) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|First dose to 30 days past last dose (Up to 27 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1420709|NCT01091428|Secondary|Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose to 30 days past last dose (Up to 27 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1420993|NCT01089361|Primary|Serum Levels of IL-6, IL-10 and TNFα||first 7 days of admission, Baseline and Day 7 reported||||pg/mL||Inter-Quartile Range|Median
1420711|NCT01091428|Secondary|Phase 2: Time to Disease Progression (TTP)|TTP was defined as the time from the date of randomization to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease or per CA-125 criteria with elevated (>70 units/mL) levels on 2 occasions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125.|Up to data-cut off: 12 August 2014 (approximately 24 months)|mITT Population was defined as all participants who were randomized and received at least 1 dose of any study drug. For a participant that has not progressed, TTP is censored at the last response assessment that is SD or better|||days||80% Confidence Interval|Median
1420712|NCT01091428|Secondary|Phase 2: Duration of Response (DOR)|DOR was defined as the time from the date of first documentation of a response to the date of first documentation of PD or the last response assessment that is stable disease (SD) or better for a participant who started alternate therapy without progression. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease or per CA-125 criteria with elevated (>70 units/mL) levels on 2 occasions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. A responder that did not experience disease progression is censored at the last response assessment that is SD.|Up to data-cut off: 12 August 2014 (approximately 24 months)|Participants from Response evaluable population, all participants who were randomized and had measurable disease according to RECIST 1.1 or assessable disease by CA-125 criteria, who received at least 1 dose of any study drug, and who had at least 1 available post-Baseline response assessment per RECIST 1.1 or CA-125 criteria, who were responders.|||days||80% Confidence Interval|Median
1420713|NCT01091428|Secondary|Phase 2: Combined Best Overall Response Rate (ORR)|Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).|At the end of Cycle 2 and at the completion of every 2 cycles until PD was documented or up to data cut-off: 12 August 2014 (approximately 24 months)|Response evaluable population was defined as all participants who were randomized and had measurable disease according to RECIST or assessable disease by CA-125 criteria, who received at least 1 dose of any study drug, and who had at least 1 available post-Baseline response assessment as per either RECIST or CA-125 criteria.|||percentage of participants||80% Confidence Interval|Number
1420714|NCT01091428|Secondary|Vz: Volume of Distribution During the Terminal Disposition Phase for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||liter||Standard Deviation|Mean
1420715|NCT01091428|Secondary|Vss: Volume of Distribution at Steady State for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||liter||Standard Deviation|Mean
1420716|NCT01091428|Secondary|CL: Total Clearance After Intravenous Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||liter per hour||Standard Deviation|Mean
1420717|NCT01091428|Secondary|t½: Terminal Half-Life for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||hour||Standard Deviation|Mean
1420718|NCT01091428|Secondary|AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||ng/mL*hr||Standard Deviation|Mean
1420719|NCT01091428|Secondary|AUClast: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||ng/mL*hr||Standard Deviation|Mean
1420790|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 17.|Baseline, Week 17|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 17.|||mmol/mmol creatinine||Standard Deviation|Mean
1420720|NCT01091428|Secondary|Cmax: Maximum Observed Concentration for Paclitaxel in Phase 1||Day 1 in Cycles 1 and 2: pre-infusion and at multiple timepoints (up to 47 hours) post-infusion|PK analysis set for paclitaxel was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and paclitaxel concentration time data to permit noncompartmental PK analysis. Number analyzed is the number of participants with evaluable data at the specified time-point.|||ng/mL||Standard Deviation|Mean
1420721|NCT01091428|Secondary|AUClast: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|PK analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng/mL*hr||Standard Deviation|Mean
1420722|NCT01091428|Secondary|AUC(Tau): Area Under the Concentration-Time Curve During a Dosing Interval for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|PK analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng/mL*hour(hr)||Standard Deviation|Mean
1420723|NCT01091428|Secondary|Tmax: Time to First Occurrence of Cmax for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|PK analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||hour||Full Range|Median
1420724|NCT01091428|Secondary|Cmax: Maximum Observed Concentration for Alisertib in Phase 1||Days 1 and 3 in Cycle 1: pre-dose and at multiple timepoints (up to 12 hours) post morning dose|Pharmacokinetic (PK) analysis set for alisertib was defined as all participants in the phase 1 portion of the study for whom there was sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.|||ng/mL||Standard Deviation|Mean
1420725|NCT01091428|Secondary|Phase 1: Combined Best Overall Response Rate (ORR) in Participants With Recurrent Ovarian Cancer or Breast Cancer|Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).|At the end of Cycle 2 and at the completion of every 2 cycles until PD was documented or up to data cut-off: 12 August 2014 (approximately 24 months)|Response evaluable population was defined as all participants who were randomized and had measurable disease according to RECIST or assessable disease by CA-125 criteria, who received at least 1 dose of any study drug, and who had at least 1 available post-Baseline response assessment as per either RECIST or CA-125 criteria.|||percentage of participants||80% Confidence Interval|Number
1420726|NCT01091428|Primary|Phase 2: Progression-Free Survival (PFS)|PFS is defined as the time from the date randomization for Phase 2 participants to the date of first documented progressive disease (PD) or death as assessed by the investigator using both RECIST 1.1 criteria and CA-125 criteria. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease or CA-125 criteria with elevated (>70 units/mL) levels on 2 occasions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125.|At the end of Cycle 2 and at the completion of every 2 cycles until PD was documented or up to data cut-off: 12 August 2014 (approximately 24 months)|The modified intent-to-treat (mITT) population was defined as all participants who were randomized and received at least 1 dose of any study drug. For a participant that has not progressed and has not died or has started the alternate therapy, PFS is censored at the last response assessment that is stable disease (SD) or better.|||days||80% Confidence Interval|Median
1420727|NCT01091428|Primary|Phase 1: Number of Participants With Hypersensitivity and Neurotoxicity||Baseline up to Month 36|"Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.~Safety population was defined as all participants who received at least 1 dose of any study drug."|||participants|||Number
1420728|NCT01091428|Primary|Phase 1: Number of Participants With Clinically Significant Vital Sign Findings|Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.|First dose to 30 days past last dose (Up to 36 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1420729|NCT01091428|Primary|Phase 1: Number of Participants With Clinically Significant Laboratory Values|Abnormal clinical laboratory values (serum chemistry, hematology and urinalysis) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|First dose to 30 days past last dose (Up to 36 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1420730|NCT01091428|Primary|Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose to 30 days past last dose (Up to 36 Months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
1420731|NCT01091428|Primary|Phase 1: MTD and RP2D for Paclitaxel in Combination With Alisertib|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of cycle 1).|Cycle 1 (Up to 28 days)|DLT-Evaluable Population was defined as all participants in the phase 1 who either experienced DLT during Cycle 1 or completed treatment with at least 15 of the planned 18 doses of alisertib and 2 of the planned 3 doses of paclitaxel in Cycle 1 and had sufficient follow-up data.|||mg/m^2|||Number
1420732|NCT01091428|Primary|Phase 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) for Alisertib in Combination With Paclitaxel|The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT). DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.02 and was defined as any of the following events: 1. Grade 4 neutropenia and thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 2 with appropriate treatment; 6. Other alisertib-related nonhematologic toxicities ≥Grade 2 that, in opinion of investigator, required a dose reduction or discontinuation of therapy with alisertib.|Cycle 1 (Up to 28 days)|DLT-Evaluable Population was defined as all participants in the phase 1 who either experienced DLT during Cycle 1 or completed treatment with at least 15 of the planned 18 doses of alisertib and 2 of the planned 3 doses of paclitaxel in Cycle 1 and had sufficient follow-up data.|||mg|||Number
1420733|NCT01091259|Secondary|Number of Patients Who Experienced Grade 3 and Higher Toxicities||up to 3 years|Any patients who had at least one dose of treatment|||participants|||Number
1420734|NCT01091259|Secondary|Median Overall Survival|Defined as the length of time from the start of treatment that half of the patients are still alive.|up to 3 years|Intent-to-treat|||months||95% Confidence Interval|Median
1420735|NCT01091259|Secondary|Median Progression Free Survival|Defined as the length of time from the start of treatment that half of the patients are still alive and without disease progression. Progression is evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range; progression is defined on the basis of a confirmed doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level)|up to 3 years|Intent-to-treat|||months||95% Confidence Interval|Median
1420736|NCT01091259|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of all patients with confirmed partial response (PR) or complete response (CR). PR and CR are evaluated by RECIST 1.0 or CA125 if no measurable disease (PR: CA125 decreases by > 50%; CR: CA125 decreases to the normal range).|up to 3 years|Intent-to-treat population|||percentage of patients||95% Confidence Interval|Number
1420737|NCT01091259|Primary|Progression Free Survival (PFS) Rate at 6 Months|The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.|6 months from the start of treatment|Intent-to-treat population.|||percentage of patients||95% Confidence Interval|Number
1420738|NCT01091246|Secondary|Percent of All Participants Reporting Any New Onset Chronic Disease (NOCD) From Administration of Investigational Product Through 180 Days Post Last Dose|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of participants|||Number
1420739|NCT01091246|Secondary|Percent of All Participants Reporting Any SAE From Administration of Investigational Product Through 180 Days Post Last Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-180 Post Last Dose|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of participants|||Number
1420740|NCT01091246|Secondary|Percent of Two-dose Participants Reporting Any SAE From Administration of Dose 2 During Days 0-28 Post Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summarized period (Q=1041; All FM=693).|||Percent of participants|||Number
1420750|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=364; All FM=244).|||Percent of participants|||Number
1420801|NCT01090973|Secondary|Number of Participants With Prolonged Corrected QT (QTc) Interval|Investigators intended to monitor the QTc interval in patients receiving oral LBH589|8 weeks (2 cycles) unless treatment continues due to partial or complete response|||||||
1420741|NCT01091246|Secondary|Percent of All Participants Reporting Any Serious Adverse Event (SAE) From Administration of Investigational Product Through Day 28 Post Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgement, may have jeopardized the participant and may have required medical or surgical intervention to prevent on the outcomes listed above.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of participants|||Number
1420742|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Dose 2 Through 28 Days Post Dose 2|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any post Dose 2 safety data were recorded during the summariezed period (Q=1041; All FM=693).|||Percent of participants|||Number
1420743|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any safety data were recorded during the summarized period (Q=1083; All FM=719).|||Percent of Participants|||Number
1420744|NCT01091246|Secondary|Percent of All Participants Experiencing Any Adverse Event From Administration of Investigational Product Through Day 28 Post Dose 1|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Days 0-28 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any safety data were recorded during the summarized period (Q=1382; All FM=923).|||Percent of Participants|||Number
1420745|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Dose 2 During Days 0-14 Post Dose 2|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 2|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1039; All FM=692).|||Percent of Participants|||Number
1420746|NCT01091246|Secondary|Percent of Two-dose Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All two-dose participants who received any investigational product (Q=1083; All FM=719) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1078; All FM=716).|||Percent of Participants|||Number
1420747|NCT01091246|Secondary|Percent of All Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose 1|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14 Post Dose 1|All participants who received any investigational product (Q=1385; All FM=927) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1377; All FM=920).|||Percent of Participants|||Number
1420748|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).|||Percent of Participants|||Number
1420749|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).|||Percent of participants|||Number
1420774|NCT01091155|Primary|To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|Approx. 1 year|||||||
1420751|NCT01091246|Secondary|Percent of Seronegative Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=460; All FM=321).|||Percent of participants|||Number
1420752|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).|||Percent of participants|||Number
1420753|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).|||Percent of participants|||Number
1420754|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H3N2 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).|||Percent of participants|||Number
1420755|NCT01091246|Secondary|Percent of Serosusceptible Participants Who Achieved an A/H1N1 HAI Antibody Titer ≥ 32 Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8.|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).|||Percent of participants|||Number
1420756|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Victoria HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FV=437).|||Percent of participants|||Number
1420757|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved a B/Yamagata HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445).|||Percent of participants|||Number
1420758|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Who Achieved an A/H1N1 or A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Immunogenicity Dose||Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; All FM=883).|||Percent of participants|||Number
1420759|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=487; FV=159).|||Percent of participants|||Number
1420760|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were seronegative to the strain (Q=483; FY=165).|||Percent of participants|||Number
1420761|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=364; All FM=244).|||Percent of participants|||Number
1420762|NCT01091246|Secondary|Percent of Seronegative Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seronegative was defined as a baseline HAI titer ≤ 4. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response and were seronegative to the strain (Q=460; All FM=321).|||Percent of participants|||Number
1435584|NCT00968864|Primary|Number of Participants With Severe Graft vs. Host Disease (GVHD).|Severe GVHD defined as grade III/IV GVHD.|Within 30 days after stem cell transplant||||Participants|||Count of Participants
1420763|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=620; FV=191).|||Percent of participants|||Number
1420764|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=588; FY=192).|||Percent of participants|||Number
1420765|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experience Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=435; All FM=298).|||Percent of participants|||Number
1420766|NCT01091246|Secondary|Percent of Serosusceptible Participants Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Serosusceptible was defined as a baseline HAI titer ≤ 8. Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and were serosusceptible to the strain (Q=569; All FM=392).|||Percent of participants|||Number
1420767|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Victoria Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FV=463), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FV=437).|||Percent of participants|||Number
1420768|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the B/Yamagata Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; FY=441).|||Percent of participants|||Number
1420769|NCT01091246|Secondary|Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H3N2 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1321; All FM=879).|||Percent of participants|||Number
1420770|NCT01091246|Secondary|The Percent of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experienced a Seroresponse to the A/H1N1 Strain Post Immunogenicity Dose|Seroresponse was defined as a ≥ 4-fold rise in HAI antibody titer from baseline.|Day 0 and Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; All FM=927), had post dose HAI antibody measurement at the appropriate time, and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1320; All FM=878).|||percent of participants|||Number
1420771|NCT01091246|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains. .|Day 28 post immunogenicity dose|All participants who received any investigational product (Q=1385; FY=464; FV=463; All FM=927), had post dose HAI antibody measurement at the appropriate time and had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response (Q=1327; FY=445; FV=437; All FM=883).|||Geometric mean titer||Full Range|Geometric Mean
1420772|NCT01091155|Primary|Device Related Leak Rate up to 30 Days Post op|Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device.|30 days post op||||participants|||Number
1420773|NCT01091155|Secondary|Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure.|"The post operative parameters that will be measured during hospitalization period:~Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home~First day to first postoperative flatus~First day to first postoperative bowel movements~First day of first postoperative toleration of liquids and solids (time to keeping them down)"|30 days post op|||||||
1421277|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1420775|NCT01091116|Secondary|Clinically Significant Abnormal Laboratory Tests|"Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators.~The following hematochemical and urinary parameters were analysed:~Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin."|up to 4 months from screening|Percentage of patients with clinically significant abnormal laboratory tests|||participants|||Number
1420776|NCT01091116|Secondary|Adverse Event Reports|Incidence of spontaneously reported adverse events|up to 4 months after screening|The number of patients reflects all patients administered at least one dose of the investigational product.|||participants|||Number
1420777|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]|"Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Over Weight patients (BMI >25)|||mm||Standard Deviation|Mean
1420778|NCT01091116|Secondary|WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]|"Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom."|over the 3 weeks after the first administration|Population of Normal Weight patients (BMI <=25)|||mm||Standard Deviation|Mean
1420779|NCT01091116|Secondary|Patient Global Assessment|"Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm).~Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0).~A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms."|up to 3 months after first dose|intention to treat (ITT) population|||mm||Standard Deviation|Mean
1420780|NCT01091116|Secondary|Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria|"Osteoarthritis Research Society International (OARSI).~Response defined as:~a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale~OR if two of the following three findings are recorded:~a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient’s global assessment by 20% or more and by 10 or more points on the scale."|up to 3 months after first dose|intention to treat (ITT) population|||percentage of patients|||Number
1420781|NCT01091116|Secondary|WOMAC VA 3.1. C Score (Function)|"Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours.~The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty).~A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities.~WOMAC VA 3.1.C scores at baseline and at Week 13 are reported."|up to 3 months after first dose|Intention to Treat (ITT) population|||mm||Standard Deviation|Mean
1420782|NCT01091116|Secondary|WOMAC VA 3.1.B Score (Knee Stiffness)|"WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness).~A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness.~The change at Week 13 from baseline is reported."|up to 3 months after first dose|Intention to Treat (ITT) population|||mm||Standard Deviation|Mean
1420783|NCT01091116|Primary|WOMAC VA 3.1 A Score (Total Pain)|"Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours.~The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain).~A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.~The change from baseline was assessed along 3 weeks after first drug administrations."|over the 3 weeks after the first administration|analysis of the intention to treat (ITT) population|||mm||Standard Deviation|Mean
1420784|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 65.|Baseline, Week 65|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 65.|||mmol/mmol creatinine||Standard Deviation|Mean
1420785|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 57.|Baseline, Week 57|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 57.|||mmol/mmol creatinine||Standard Deviation|Mean
1420786|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 49.|Baseline, Week 49|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 49.|||mmol/mmol creatinine||Standard Deviation|Mean
1420787|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 41.|Baseline, Week 41|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 41.|||mmol/mmol creatinine||Standard Deviation|Mean
1420788|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide||Baseline, Week 33|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 33.|||mmol/mmol creatinine||Standard Deviation|Mean
1420789|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 25.|Baseline, Week 25|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 25.|||mmol/mmol creatinine||Standard Deviation|Mean
1420791|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 9.|Baseline, Week 9|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 9.|||mmol/mmol creatinine||Standard Deviation|Mean
1420792|NCT01091103|Secondary|Change From Baseline in Urinary N-Telopeptide|Samples for measurement of urinary N-telopeptide were collected at baseline prior to initiation of enzalutamide administration and at Week 5.|Baseline, Week 5|Participants who received any amount of enzalutamide and had urinary N-telopeptide measurements at baseline and at Week 5.|||mmol/mmol creatinine||Standard Deviation|Mean
1420793|NCT01091103|Secondary|Median Time to Study Drug Discontinuation|Exposure to study drug through the data cutoff of 26AUG2011 only. Fifteen participants (25.0%) were still on study drug as of the data cut-off date and were censored at this date.|Duration of study treatment through the data cutoff, up to 3 years.|All participants who received any amount of enzalutamide. Fifteen (25.0%) participants were still on study drug as of the data cutoff date and were censored at the data cutoff date.|||months||95% Confidence Interval|Median
1420794|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry.~Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.~The change from baseline in bone marrow dihydrotestosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
1420795|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.~Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.~The change from baseline in bone marrow testosterone levels at Week 9 was correlated with PSA response status at Week 9."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
1420796|NCT01091103|Primary|Change From Baseline in Bone Marrow Dihydrotestosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.~Assessment of intratumoral dihydrotestosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow dihydrotestosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
1420797|NCT01091103|Secondary|Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA)|Serum samples for measurement of PSA levels were obtained at baseline prior to initiation of enzalutamide administration and at the Week 9 visit.|Baseline, Week 9|Participants who received any amount of enzalutamide and had PSA values at baseline and at the Week 9 Visit.|||percentage of participants||95% Confidence Interval|Number
1420798|NCT01091103|Primary|Change From Baseline in Bone Marrow Testosterone|"Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit.~Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry."|Baseline, Week 9|Participants who received any amount of enzalutamide and had bone marrow testosterone measurements at baseline and at least 1 post-baseline assessment. Note that the documentation of bone marrow involvement with cancer was not required.|||ng/mL||Standard Deviation|Mean
1420799|NCT01090973|Secondary|Number of Participants With Adverse Events (AEs)|"Investigators intended to evaluate the safety and tolerability profile of LBH589. Assessments would consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry and urine values, vital signs, ECOG performance status, and the regular physical examinations and ECG assessments.~Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. CTCAE v3.0 can be accessed on the National Institute of Health (NIH)/NCI website at http://ctep.cancer.gov/forms/CTCAEv3.pdf."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."|||participants|||Number
1420800|NCT01090973|Secondary|Number of Participants With Improved Blood and Lymphatic Evaluation Results|Investigators intended to evaluate histone acetylation, cytotoxic mixed lymphocyte reaction (MLR) activity, cytokine profiles, and immunologic synapse alterations through peripheral blood correlative studies|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
1430835|NCT01002339|Secondary|Renal Function|Estimated Glomerular Filtration Rate (ml/min/1.73 m^2)|1 year|Participants analyzed: Participants living with a functioning graft at study end.|||ml/min/1.73 m^2||95% Confidence Interval|Mean
1420802|NCT01090973|Secondary|Progression Free Survival (PFS) Estimate|Investigators intended to estimate the progression free survival time|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
1420803|NCT01090973|Secondary|Response Duration|Investigators intended to determine the duration of responses.|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
1420804|NCT01090973|Secondary|Number of Participants With Complete Response (CR) and Partial Response (PR)|"Investigators intended to determine the complete and partial responses. Chronic Lymphocytic Leukemia (CLL): Using the NCI criteria - - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response.~Mantle Cell Lymphoma (MCL): Based on the International Workshop to Standardize Response Criteria to NHL (Cheson, JCO 1999) - See definitions in the Detailed Description section for a Complete hematologic Remission, and Partial Response."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
1420805|NCT01090973|Primary|Number of Participants With Desired Response|"Investigators intended to assess the rate of overall and complete response by World Health Organization (WHO) classification in patients with relapsed or refractory aggressive mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).~WHO Performance Scale Measures levels of patient capability: 0 Normal activity; 1 Symptoms, but nearly fully ambulatory; 2 Some bed time, but needs to be in bed <50% of normal daytime; 3 Needs to be in bed >50% of normal daytime; 4 Unable to get out of bed."|8 weeks (2 cycles) unless treatment continues due to partial or complete response|"The study was abandoned after only one patient due to low accrual and the sponsor losing interest in the single-agent.~The one patient had disease progression requiring more aggressive treatment and did not complete the study."||||||
1420806|NCT01090765|Secondary|Clinical Response|Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% decrease in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|56 days (one cycle = 28 days, restaging post cycle 2)||||Participants|||Count of Participants
1420807|NCT01090765|Secondary|Prostatic-Specific Antigen (PSA) Decline|PSA decline (i.e., PSA greater than 4.0 ng/mL) is defined as two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting values for PSA). Normal PSA is 4.0 ng/mL or lower.|1- week intervals up to 6 months||||Participants|||Count of Participants
1420808|NCT01090765|Secondary|Dose Limiting Toxicity (DLT)|Dose limiting toxicity is defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possibly related to TRC105.|First 28 days on study||||Participants|||Count of Participants
1420809|NCT01090765|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 43 months, 5 days||||Participants|||Count of Participants
1420810|NCT01090765|Primary|Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.|The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.|6 months||||mg/kg every 2 weeks|||Number
1420811|NCT01090752|Secondary|Effects of Pioglitazone on Salt Sensitivity||2009||2010-06-30|06/2010||||
1420812|NCT01090752|Primary|Effects of Pioglitazone on 24h Blood Pressure Control|24 hour blood pressure measurements were performed after each treatment/diet phase|march 2009||||mmHg||Standard Error|Mean
1420813|NCT01090752|Primary|Effects of Pioglitazone on Sodium and Lithium Clearances|At the end of each treatment and diet phase, 24 urine collections were collected for the determination of sodium and lithium clearances|2007||||ml/min||Standard Error|Mean
1420814|NCT01090752|Primary|Effects of Pioglitazone on Renal Hemodynamics|At the end of each treatment diet phase, renal clearances were performed for the determination of GFR and RBF|2008||||ml/min/1.73m2||Standard Error|Mean
1420815|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Physician Visits Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects|||physician visits||Standard Deviation|Mean
1420816|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI|Change in health resource usage using sponsor-created questionnaire|36 Month Follow-up Visit|All implanted subjects|||days||Standard Deviation|Mean
1420817|NCT01090739|Other Pre-specified|Change in Health Resource Usage: # Pads Per Day Subject Took for FI|Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI|36 Month Follow-up Visit|All implanted subjects|||pads per day||Standard Deviation|Mean
1420818|NCT01090739|Other Pre-specified|Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)|The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better|36 Month Follow-up Visit|All implanted subjects|||units on a scale||Standard Deviation|Mean
1420819|NCT01090739|Secondary|Change in Numeric Pelvic Pain Scale (NPPS)|Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.|12 Month Follow-up Visit|All subjects implanted at the time the NPPS was implemented in the study|||units on a scale||Standard Deviation|Mean
1420820|NCT01090739|Secondary|Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)|Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
1420821|NCT01090739|Secondary|Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores|"Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).~The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score."|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
1420822|NCT01090739|Secondary|Change in Pelvic Floor Distress Inventory (PFDI-20) Scores|"Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13).~The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale."|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
1420823|NCT01090739|Secondary|Change in Fecal Incontinence Quality of Life Score|Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
1420824|NCT01090739|Secondary|Change in Wexner Symptom Severity Score|Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.|36 Month Follow-up Visit|All subjects implanted|||units on a scale||Standard Deviation|Mean
1420825|NCT01090739|Secondary|Change in Urge Fecal Incontinence Episodes|Number of urge fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted|||urge fecal incontinent episodes/14 days||Full Range|Median
1420826|NCT01090739|Secondary|Change in Fecal Incontinence Days|Number of fecal incontinence days in a 14 day period|36 Month Follow-up Visit|All subjects implanted|||fecal incontinent days/14 days||Full Range|Median
1420827|NCT01090739|Secondary|Change in Fecal Incontinence Episodes|Number of fecal incontinence episodes in a 14 day period|36 Month Follow-up Visit|All subjects implanted|||fecal incontinent episodes/14 days||Full Range|Median
1420828|NCT01090739|Primary|Percentage of Responders|The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.|12 Months|All subjects implanted|||percentage of treatment responders||95% Confidence Interval|Number
1420829|NCT01090492|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Values|ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.|Screening up to 28 days after last study dose (up to 98 days)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||participants|||Number
1420830|NCT01090492|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements|Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.|Screening up to 28 days after last study dose (up to 98 days)|Safety analysis set consisted of all participants who took at least 1 dose of study medication.|||participants|||Number
1420831|NCT01090492|Secondary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leukocytes (<0.6 LLN /greater than [>] 1.5*upper LN [ULN]; platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8* LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (>3*ULN); BUN, creatinine (>1.3*ULN); glucose (<0.6 LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN/>1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN/>1.1*ULN); albumin, total protein (<0.8*LLN/>1.2*ULN); creatine kinase (>2.0*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.|Screening up to 28 days after last study dose (up to 98 days)|Analysis population included all randomized participants who took at least 1 dose of study medication along with at least 1 on-treatment laboratory test result.|||participants|||Number
1420832|NCT01090492|Secondary|Plasma Concentration of PF-00489791 and Its Metabolites|Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.|Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)|Analysis population included participants who received 1 dose of study drug and were analyzed for pharmacokinetic parameters. Here, Overall number of participants signifies participants evaluable for either first or second intervention period and number analyzed signifies those participants who were evaluable at specified time points.|||mcg/mL||Standard Deviation|Mean
1420833|NCT01090492|Secondary|Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud’s Phenomenon Cohort|Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.|Baseline, Day 14, 28|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||participants|||Number
1420834|NCT01090492|Secondary|Change From Baseline in the Mean Raynaud’s Pain Score at Week 1, 2, 3 and 4|Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud’s pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud’s pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.|Baseline, Week 1, 2, 3, 4|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
1420835|NCT01090492|Secondary|Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4|Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.|Baseline, Week 4|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||minutes per attack||Standard Deviation|Mean
1420836|NCT01090492|Secondary|Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4|Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.|Baseline, Week 1, Week 2, Week 3, Week 4|PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.|||Raynaud's attacks||Standard Deviation|Mean
1420837|NCT01090492|Primary|Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4|The Raynaud’s Condition score (RCS) is participant’s rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud’s phenomenon every day and impact of Raynaud’s alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud’s pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.|Baseline, Week 4|Per-protocol analysis set (PPAS) included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion.|||units on a scale||Standard Deviation|Mean
1420838|NCT01090479|Secondary|Qualitative and Quantitative Bacterial Cultures of the Operative Shoulder Just Prior to Surgery||7 days|||||||
1420839|NCT01090479|Primary|Number of Patients With a Clinically Diagnosed Infection||2 months post-operatively||||participants|||Number
1420840|NCT01090453|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1420841|NCT01090453|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
1420842|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.|||Participants|||Count of Participants
1420843|NCT01090453|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and the symptom sheet completed.|||Participants|||Count of Participants
1420844|NCT01090453|Secondary|Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.|The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420845|NCT01090453|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||µg/mL||95% Confidence Interval|Geometric Mean
1420846|NCT01090453|Secondary|Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.|The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Month 3 and Month 11|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420847|NCT01090453|Secondary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration|At Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420848|NCT01090453|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1420849|NCT01090453|Secondary|Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.|The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420850|NCT01090453|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||titers||95% Confidence Interval|Geometric Mean
1420851|NCT01090453|Secondary|Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.|The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420852|NCT01090453|Secondary|Concentrations for Anti-HBs.|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||mIU/mL||95% Confidence Interval|Geometric Mean
1420946|NCT01089556|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint|TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).|||participants|||Number
1420853|NCT01090453|Secondary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420854|NCT01090453|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||IU/mL||95% Confidence Interval|Geometric Mean
1420855|NCT01090453|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.|The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420856|NCT01090453|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||titers||95% Confidence Interval|Geometric Mean
1420857|NCT01090453|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||µg/mL||95% Confidence Interval|Geometric Mean
1420858|NCT01090453|Secondary|Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs|The rSBA-MenC antibody titers cut-off for this assay were ≥ 1:8 and ≥ 1:128. Values concerning the cut-off of 1:8 at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420859|NCT01090453|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs|The anti-PRP antibody concentration cut-offs for this assay were ≥ 0.15 µg/mL and 1.0 µg/mL. Values concerning the cut-off of 0.15 µg/mL at Month 3 were listed for a primary outcome, hence they were not reported under this outcome.|At Month 3, Month 10 and Month 11.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420860|NCT01090453|Primary|Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off|The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420861|NCT01090453|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off|The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Participants|||Count of Participants
1420862|NCT01090427|Secondary|The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1||Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.|||Percentage of participants|||Number
1420883|NCT01090076|Primary|% Viable Tissue|"-Percentage viable tissue after 2 weeks~The estimated change in proportion of viable and non-viable tissue was determined using area derived from planimetry via acetate tracings. The description of viable tissue was taken to mean granulating (red) or epithelising (pink) tissue, and non-viable tissue were taken as necrotic (black) or sloughy (green or yellow) tissue."|weeks 1 to 2||||Percentage of viable tissue||Standard Error|Mean
1420910|NCT01090011|Secondary|Concentration of Afatinib in Plasma for the Combination Arm|Minimum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmin,ss). Maximum measured concentration of Afatinib in plasma at steady state over 15 day dosing interval (Cmax,ss).|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1420863|NCT01090427|Secondary|The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12|The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.|||Scores on a scale||Standard Deviation|Mean
1420864|NCT01090427|Secondary|The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.|||Percentage of participants|||Number
1420865|NCT01090427|Secondary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12|The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.|Week 12|Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.|||Percentage of participants|||Number
1420866|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.|Week 12|The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.|||Percentage of Participants|||Number
1420867|NCT01090427|Secondary|Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups|The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child’s quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.|Baseline; Week 12|Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.|||Scores on a scale||Standard Deviation|Mean
1420868|NCT01090427|Secondary|The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.|Week 12|The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.|||Percentage of Participants|||Number
1420869|NCT01090427|Primary|The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12|The PGA documents the physician’s assessment of the participant’s psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.|Week 12|The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.|||Percentage of Participants|||Number
1420870|NCT01090323|Secondary|Change in Serum Ferritin From Start of ICL670 to End of Study|The main efficacy variable was change in serum ferritin in response to therapy with ICL670. Due to variability of serum ferritin, end of study was considered as the mean of at most the last 3 available observations after the start of ICL670.|0 - 60 months|The primary analysis was on Full Analysis Set which comprised all participants who received at least one dose of ICL670 during the core or the extension phase of the study. All participants previously treated with ICL670 or DFO for 52 weeks in the core study were eligible for enrollment.|||µg/L||Full Range|Median
1420871|NCT01090323|Primary|Number of Participants With Adverse Events After Start of ICL670|Safety as assessed by the number of participants with adverse event or death after the start of ICL670.|0 - 60 months|The primary analysis was on Safety Analysis Set which comprised all participants who received at least one dose of ICL670 during the core/extension phase of the study. All participants previously treated with ICL670/DFO for 52weeks in the core study.|||participants|||Number
1420872|NCT01090310|Secondary|Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension|IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Units on a scale||Standard Deviation|Mean
1420873|NCT01090310|Secondary|Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies|Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Number of participants|||Number
1420874|NCT01090310|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Letters||Standard Deviation|Mean
1420875|NCT01090310|Secondary|Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Number of participants|||Number
1420876|NCT01090310|Primary|The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension|Baseline to 52 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Days||95% Confidence Interval|Median
1420877|NCT01090180|Secondary|Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR). Because Depression Can be Comorbid With PTSD (70% Comorbidity Found in Pilot Sample), This Assessment Will be Used to Measure Depressive Symptoms Over a 1 Week Timeframe|The QIDS-SR is a 16-item measure of depression symptom severity with a range from 0-27. Each item is rated from 0-3 with higher scores are indicative of higher symptom severity. Scores of the items are aggregated (with the highest score on overlapping items chosen; e.g., sleep disturbances, changes in eating) to generate the total score..|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.||||units on a scale||Standard Deviation|Mean
1420878|NCT01090180|Primary|PTSD Checklist (PCL). A Self-report, Face Valid Measure of PTSD Symptoms Over a 1 Week Time Period|The PCL is a 17-item measure of PTSD symptom severity with a range from 17-85. Each item is rated from 1-5 with higher scores are indicative of higher symptom severity. Scores of the 17 items are summed in order to generate the total score.|This measure will be administered at all study visits: Baseline, 1 month, 3 months, and 6 months follow up.|Male veterans with combat-related PTSD|||units on a scale||Standard Deviation|Mean
1420879|NCT01090102|Secondary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells After Treatment Crossover|Log(10) change in the percentage of activated T cells during the second 12 weeks of the study|Week 12, Week 24||||Log10(percentage of T cells)||95% Confidence Interval|Mean
1420880|NCT01090102|Primary|Log(10) Change in % Activated (CD38+HLA-DR+)CD8+ T Cells During the First 12 Weeks of Study||Week 0, Week 12|1 participant assigned to first receive Mesalamine was excluded from analysis due to having withdrawn participation without receiving the allocated intervention|||Log10(percentage of T cells)||95% Confidence Interval|Mean
1420881|NCT01090076|Primary|% Wound Area Week 2|Percentage change in wound area after week 2|Weeks 1 to 2||||Percentage change||Standard Error|Mean
1420882|NCT01090076|Primary|% Wound Area Week 1|Percentage change in wound area after week 1|week 0 to 1||||percent change||Standard Error|Mean
1420909|NCT01090011|Secondary|Peak-trough Fluctuation (PTF)|Peak-trough fluctuation (PTF) of plasma afatinib for the combination arm. PTF = 100*(Cmax-Cmin)/Caverage where Caverage = AUC/time, where time equals 24 hours.|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||% of average concentration||Geometric Coefficient of Variation|Geometric Mean
1420884|NCT01090063|Secondary|Safety Outcome Measures|All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends.|24 weeks|All participants who enrolled. Participants terminating prior to week 24 had their data carried forward as lost to follow-up.|||participants|||Number
1420885|NCT01090063|Secondary|Pain Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how much pain are you experiencing from your disease of your hands and feet, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||units on a scale||Standard Deviation|Mean
1420886|NCT01090063|Secondary|Pruritus Visual Analog Scale From Baseline to Week 24|"Patient's score on the questionnaire of how itchy are you, as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome)."|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||units on a scale||Standard Deviation|Mean
1420887|NCT01090063|Secondary|Fissure Count (if Present at Baseline) From Baseline to Week 24|Number of discrete fissures on the hands and feet of each subject.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||fissures||Standard Deviation|Mean
1420888|NCT01090063|Secondary|Pustule Count (if Present at Baseline) From Baseline to Week 24|Number of pustules present in each subject|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||pustules||Standard Deviation|Mean
1420889|NCT01090063|Secondary|PGA Score Over Time From Baseline to Week 24|Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear.|Baseline, 24 weeks|All participants who enrolled. Early terminations were carried as last observation carried forward.|||units on a scale||Full Range|Median
1420890|NCT01090063|Primary|Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.||16 weeks|Number of participants completing enrollment. Lost values carried forward as last observation carried forward|||percentage of participants|||Number
1420891|NCT01090050|Secondary|Compliance With Lifestyle Changes|Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome.|Day 121||||Units on a scale||Standard Deviation|Mean
1420892|NCT01090050|Secondary|Migraine Disability Assessment(MIDAS)Questionnaire Total Score|"Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline MIDAS collected at Day 31, Post final dose study at Day 121.||||scores on a scale||Standard Deviation|Mean
1420893|NCT01090050|Secondary|Percent Change of Doses of Study Medication|"Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%)."|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.||||percent doses of study medication||Standard Deviation|Mean
1420894|NCT01090050|Secondary|Migraine Headache Days With Greater Than 50% Reduction|Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.||||participants|||Number
1420895|NCT01090050|Secondary|Migraine Headache Duration From Time of Treatment to Pain Free|"Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.||||percent hours of migraine duration||Standard Deviation|Mean
1420896|NCT01090050|Secondary|Migraine Headache Duration From Onset to Pain Free|"Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%)"|Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.||||percent hours of migraine duration||Standard Deviation|Mean
1420897|NCT01090050|Secondary|Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline|"Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation.~e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)"|Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.||||percent migraine headache days per month||Standard Deviation|Mean
1420898|NCT01090050|Primary|Percent Change of Migraine Headache Days Compared to Baseline|Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)|Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.||||percent migraine headache days per month||Standard Deviation|Mean
1420899|NCT01090011|Secondary|Progression-Free Survival (PFS) Time|Progression-Free Survival was defined as the duration of time from start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to RECIST 1.1) or death.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||months||95% Confidence Interval|Median
1420900|NCT01090011|Secondary|Duration of Disease Control (According to RECIST v1.1)|Duration of disease control was defined as the time from the start of treatment to the time of progression or death (whichever occurred first), among patients with evidence SD, PR or CR.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||months||Standard Deviation|Mean
1420901|NCT01090011|Secondary|Duration of Objective Response (According to RECIST v1.1)|Duration of objective response was measured from the time measurements criteria were met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded since treatment started).|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||months||Standard Deviation|Mean
1420902|NCT01090011|Secondary|Objective Tumor Response (Complete Response [CR] and Partial Response [PR]) Determined by RECIST v1.1)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Objective tumor response = CR + PR."|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
1420903|NCT01090011|Secondary|Disease Control (CR, PR and Stable Disease (SD) Determined by RECIST v1.1)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesion(s); Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Disease control = CR + PR + SD.|up to 116 weeks|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients||95% Confidence Interval|Number
1420904|NCT01090011|Secondary|Predose Plasma Concentrations of Afatinib for the Combination Arm|Predose plasma concentrations (Cpre,ss) of Afatinib at Course 1, Visit 2, 3, 4 and 5, at Course 2, Visit 1 and 2 and at Course 3, Visit 1.|Up to 57 days|Pharmacokinetic dataset (PKS)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1420905|NCT01090011|Secondary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||L||Geometric Coefficient of Variation|Geometric Mean
1420906|NCT01090011|Secondary|CL/F,ss,15|Apparent clearance of afatinib in plasma at steady state after extravascular multiple dose administration (CL/F,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1420907|NCT01090011|Secondary|MRTpo,ss|mean residence time of Afatinib in the body at steady state after oral administration (MRTpo,ss) for 15 days|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||h||Geometric Coefficient of Variation|Geometric Mean
1420908|NCT01090011|Secondary|t1/2,ss|Terminal half-life of Afatinib in plasma at steady state (t1/2,ss)|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||h||Geometric Coefficient of Variation|Geometric Mean
1420911|NCT01090011|Secondary|Area Under the Concentration-time Curve (AUC) on Day 15 of Plasma Afatinib for the Combination Arm|Area Under the Concentration-time Curve (AUC) of Afatinib in plasma at steady state over a uniform dosing interval tau (15 days) (AUCtau,ss) after oral administration of Afatinib and cetuximab combination therapy|Course 1, Visit 3 and 4, Day 15 and 16, Hours: -0:05,0,1,2,3,4,5,6,8, and 23:55|Pharmacokinetic dataset (PKS)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1420912|NCT01090011|Secondary|Frequency (%) of Patients With Related Serious Adverse Events|Frequency (%) of patients with drug-related serious adverse events|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
1420913|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Death||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
1420914|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Treatment Discontinuation|Frequency (%) of patients with adverse events leading to treatment discontinuation|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
1420915|NCT01090011|Secondary|Frequency (%) of Patients With Adverse Events Leading to Dose Reduction||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
1420916|NCT01090011|Secondary|Frequency of Patients [N(%)] With Possible Clinically Significant Abnormalities for Selected Laboratory Parameters||From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
1420917|NCT01090011|Secondary|Highest CTCAE Grade|Safety of afatinib when administered together with cetuximab as indicated by intensity and incidence of adverse events, graded according to the U.S. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version (v) 3.0|From first drug administration to 28 days after discontinuation of drug intake up to 915 days|Treated set. 32 patients in the Afa40-mono group had disease progression and were transitioned to treatment with Afa40+Ctx500. Thus the total of 203 patients (4+126+37+36) minus the 32 patients counted in both 'Afa-mono' and 'Afa40+Ctx500' treatments arms equals 171, the total number of patients started in participant flow section.|||percentage of patients|||Number
1420918|NCT01090011|Primary|The Primary Endpoint is the Occurrence of Dose Limiting Toxicity (DLT).|"A DLT was defined as an AE or laboratory abnormality that a) related to the study regimen; b) or met any of the following criteria:~CTCAE Grade 2 or higher decrease in cardiac left ventricular function~CTCAE Grade 2 diarrhea lasting for 7 or more days, despite appropriate use of standard anti-diarrheal therapy~CTCAE Grade ≥3 diarrhea despite appropriate use of standard anti-diarrheal therapy for at least 2 days~CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days~CTCAE Grade ≥3 rash despite standard medical management~CTCAE Grade ≥3 fatigue lasting for more than 7 days~CTCAE Grade 4 hypomagnesaemia or Grade 3 hypomagnesaemia with clinical significant sequelae~All other toxicities of CTCAE Grade ≥3 (except alopecia, and allergic reaction) leading to an interruption of afatinib and/or cetuximab for more than 14 days until recovery to baseline or Grade 1, whichever was higher."|from day 1 treatment until progression or undue toxicity, up to 28 days|Treated set for Cohort One. Cohort one was based on the data from the first treatment cycle where four patients received 'Afatinib 40+Cetuximab 250' and six patients received 'Afatinib 40+Cetuximab 500'.|||participants|||Number
1420919|NCT01089751|Secondary|Change From Baseline in Urgency Urinary Incontinence (UUI)|Urgency urinary incontinence is identified if the patient marks “Yes” for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||UUI episodes||Standard Deviation|Mean
1420920|NCT01089751|Secondary|Change From Baseline in Urgency Severity|The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Score on a scale||Standard Deviation|Mean
1420921|NCT01089751|Secondary|Change From Baseline in Voided Volume|Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||cubic centimeters (cc)||Standard Deviation|Mean
1420922|NCT01089751|Secondary|Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)|The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores <= 30 indicate mild OAB, scores > 30 to 39 indicate moderate OAB, and scores >= 40 indicate severe OAB. A negative change from Baseline indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Score on a scale||Standard Deviation|Mean
1420923|NCT01089751|Secondary|Change From Baseline in Urgency-Related Toilet Voids|Urgency-related toilet void (or urinary urgency) is identified if the patient marks “Yes” for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Toilet void||Standard Deviation|Mean
1420924|NCT01089751|Secondary|Change From Baseline in Nocturic Toilet Voids|A nocturic (nighttime) toilet void is identified if the patient marks “Yes” for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Nocturic toilet void||Standard Deviation|Mean
1420925|NCT01089751|Secondary|Change From Baseline in Continent Days Per Week (CDW)|Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.|Baseline, Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Continent days per week||Standard Deviation|Mean
1420926|NCT01089751|Primary|Percentage of Patients Continent (PPC)|PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.|Week 14|Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked “Yes” for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary.|||Percentage of participants|||Number
1420927|NCT01089608|Primary|Visual Analogue Scale (VAS - Ranges 0-100 mm)|The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)|Baseline and D63 (D63 minus baseline)|Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available.|||units on a scale (from 0 to 100 mm)||95% Confidence Interval|Least Squares Mean
1420928|NCT01089595|Secondary|Best Overall Response Using Response Evaluation Criteria in Solid Tumors, Choi Criteria, and Positron Emission Tomography Imaging||Every 8 weeks for up to 5 years|Too few participants to provide meaningful analysis|||Participants|||Count of Participants
1420929|NCT01089595|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. It will be determined for both RECIST (Response Evaluation Criteria in Solid Tumors) and CHOI criteria.|6 months until death or for 5 years||||weeks||Standard Deviation|Mean
1420930|NCT01089582|Secondary|Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12|The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.|Baseline to Week 12.|FAS.|||participants|||Number
1420931|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT||Week 12.|FAS.|||participants|||Number
1420932|NCT01089582|Secondary|Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation|The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.|Baseline to Week 12.|FAS. Starting dose of ARICEPT was not summarized.|||participants|||Number
1430836|NCT01002339|Secondary|Rejection|Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.|1 year||||percentage of participants||95% Confidence Interval|Number
1420933|NCT01089582|Primary|Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.|||scores on a scale||Standard Deviation|Mean
1420934|NCT01089582|Primary|Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12|QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 [poor] to 4 [excellent]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.|Baseline, Week 12.|FAS; (n)=number of participants evaluable at baseline and Week 12.|||scores on a scale||Standard Deviation|Mean
1420935|NCT01089582|Primary|Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12|The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question ‘compared to the severity of your relative’s condition at baseline, how much do you feel it has changed?’.|Baseline, Week 12.|FAS.|||participants|||Number
1420936|NCT01089582|Primary|Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12|CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.|Baseline, Week 12.|Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT.|||participants|||Number
1420937|NCT01089569|Secondary|Change From Baseline in Weight Changes|"Measure the changes in weight attributable to exenatide, insulin glargine and their combinations.~Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.~Change from baseline was calculated as weight in pounds at baseline minus weight in pounds at final visit (32 weeks)."|baseline - final visit (32 weeks)||||lbs (pounds)||Standard Deviation|Mean
1420938|NCT01089569|Secondary|Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) Change from baseline was calculated as area under the diurnal median curve at baseline minus AUC value at final visit (32 weeks).~AUC is calculated using modified rectangle method AUC = sum of superscript 23, subscript i=0 P subscript 50i I = hour of day P subscript 50i = smoother 50th percentile value for ith hour of day"|baseline - final visit (32 weeks)||||mg/dL*24hr||Standard Deviation|Mean
1420939|NCT01089569|Secondary|Change From Baseline in CGM Glucose Variability|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- ii. Glucose variability (inter-quartile range)~IQR is the difference between the 75th and 25th percentiles. Change from baseline was calculated as IQR at baseline minus IQR value at final visit (32 weeks)."|baseline to final visit (32 weeks)||||mg/dL||Standard Deviation|Mean
1420940|NCT01089569|Secondary|Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves iii. Glucose stability (absolute hourly rate of change in median curve)~Change from baseline was calculated as mean absolute hourly rate of change in median curve at baseline minus rate at final visit (32 weeks). Mean absolute hourly rate of change in the smoothed median curve is calculated as delta subscript MC = (|p subscript 50 zero - p subscript 50 23|+Sum superscript 23 subscript i = 1| p subscript 50i - p subscript 50 i-1| over T.~i = hour of day p subscript 50i = smoothed 50th percentile value for ith hour of day T = total # of non-missing hourly smoothed percentiles"|baseline to final visit (32 weeks)||||mg/dL/hr||Standard Deviation|Mean
1420941|NCT01089569|Secondary|Change From Baseline in Incidence of Hypoglycemia (Degree)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (degree) Change from baseline was calculated as mean incidence percentage at baseline minus mean incidence percentage at final visit (32 weeks)"|baseline to final visit (32 weeks)||||percentage of measures under 70 mg/dL||Standard Deviation|Mean
1420942|NCT01089569|Secondary|Change From Baseline in Incidence of Hypoglycemia (Frequency)|"Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes.~Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (frequency)~Change from baseline was calculated as mean incidence rate at baseline minus mean incidence rate at final visit (32 weeks)"|baseline to final visit (32 weeks)||||episodes/day||Standard Deviation|Mean
1420943|NCT01089569|Primary|HbA1c Change|"Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination.~Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin."|baseline to final visit (32 weeks)||||%HbA1c||Standard Deviation|Mean
1420944|NCT01089556|Secondary|Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint||Week 8 through Week 16|All randomized participants who received at least one dose of study drug during Weeks 9-16 (Study Period III).|||participants|||Number
1420947|NCT01089556|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (TEAE) Between Baseline and Week 8 Endpoint|TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0.|Baseline through Week 8|All randomized participants who received at least one dose of study drug during Weeks 1-8 (Study Period II).|||participants|||Number
1420948|NCT01089556|Secondary|Mean Change in Heart Rate From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one heart rate measurement during Weeks 9- 16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
1420949|NCT01089556|Other Pre-specified|Mean Change in Heart Rate From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline heart rate measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||beats per minute (bpm)||95% Confidence Interval|Least Squares Mean
1420950|NCT01089556|Secondary|Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BP measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
1420951|NCT01089556|Other Pre-specified|Mean Change in Blood Pressure (BP) From Baseline to Week 8 Endpoint|Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BP measurement during Week 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||millimeter of mercury (mm Hg)||95% Confidence Interval|Least Squares Mean
1420952|NCT01089556|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and at least one PGI-I measurement during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420953|NCT01089556|Other Pre-specified|Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint|Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and at least one post-baseline PGI-I measurement during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420954|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 9-16 (Study Period III).|||hours||Standard Deviation|Mean
1420955|NCT01089556|Other Pre-specified|Average Number of Hours Worked for Pay Per Week Baseline Through Week 8|Data presented are the average number of hours worked for pay per week during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 1-8 (Study Period II).|||hours||Standard Deviation|Mean
1420956|NCT01089556|Secondary|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Week 8 through Week 16|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 9-16 (Study Period III).|||days||Standard Deviation|Mean
1420957|NCT01089556|Other Pre-specified|Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8|Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 1-8 (Study Period II).|||days||Standard Deviation|Mean
1420958|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one HADS measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420976|NCT01089543|Primary|Rate of Complete Dyspepsia Symptom Relief|The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) population defined as those participants who complied with the study protocol.|||Percentage of Participants|||Number
1420959|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline HADS measurements during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420960|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one SDS measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420961|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline SDS measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
1420962|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one NPSI measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420963|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire|The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline NPSI measurements during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420964|NCT01089556|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 16|All randomized participants who received at least one dose of study drug, and had at least one CGI-I measurement during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420965|NCT01089556|Other Pre-specified|Clinical Global Impression of Improvement (CGI-I) at Week 8 Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit.|Week 8|All randomized participants who received at least one dose of study drug, and had at least one post-baseline CGI-I measurement during Weeks 1-8 (Study Period II).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420966|NCT01089556|Secondary|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
1420977|NCT01089517|Secondary|Proportion of Patients With at Least 1 Adverse Event||24 weeks|Safety Analysis Population|||% of patients with adverse events|||Number
1420978|NCT01089517|Secondary|The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit|The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit|24 weeks|Intent to Treat Population (last observation carried forward)|||% subjects (i.e gaining >/=15 letters)|||Number
1420967|NCT01089556|Other Pre-specified|Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
1420968|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
1420969|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
1420970|NCT01089556|Secondary|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Week 8 through Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
1420971|NCT01089556|Other Pre-specified|Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline through Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.|||percentage of participants|||Number
1420972|NCT01089556|Secondary|Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score|BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420973|NCT01089556|Other Pre-specified|Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit.|Baseline, Week 8|All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II).|||units on a scale||90% Confidence Interval|Least Squares Mean
1420974|NCT01089556|Primary|Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form|BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II.|Week 8, Week 16|All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).|||units on a scale||95% Confidence Interval|Least Squares Mean
1420975|NCT01089543|Secondary|Rate of Satisfactory Symptom Relief|"The rate of satisfactory symptom relief according to the DSQ defined as scores of <= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of <= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered yes or no when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants."|Up to 8 Weeks (including 7 days prior)|Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol.|||Percentage of participants|||Number
1421616|NCT01083576|Secondary|Detectable Paromomycin or Gentamicin Plasma Levels|Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected|20 days|Adults ages >= 17 years|||Participants|||Number
1420980|NCT01089504|Secondary|Number of Participants With One or More Seizures|Any clinical or electrographic seizures occurring between study entry and all follow-up examinations and contacts.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.|||participants|||Number
1420981|NCT01089504|Secondary|Mean Bayley Scales of Infant Development (BSID) Score - Motor|This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
1420982|NCT01089504|Primary|Mean Bayley Scales of Infant Development (BSID) Score - Cognitive|The Bayley Scales of Infant Development (BSID) measure the mental and motor development and test the behavior of infants from one to 42 months of age. The test is intended to measure a child's level of development in three domains: cognitive, motor, and behavioral. The primary outcome is the Bayley assessment of development at 2 years of age. This is a standardized developmental exam that is normalized to the age of the child in months. The mean adjusted score is 100 with a standard deviation of 15 (higher being better) – very similar to the more familiar IQ score.|18-22 months|Due to low enrollment, there was limited data available for analysis and therefore insufficient power to provide meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
1420983|NCT01089413|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG performance status measured on a 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status. For each time-point, only categories with available data are reported.|Baseline up to Cycle 51 (1 cycle = 21 days)|FAS. Here, number of participants analyzed = participants with available data for this outcome and n = participants with available data for specified category, for each arm, respectively. No participants were evaluable for Cycles 48-50; hence, no data reported for these cycles.|||percentage of participants|||Number
1420984|NCT01089413|Secondary|Percentage of Participants With Best Overall Response|Tumor response was assessed using RECIST. Complete Response (CR): disappearance of all target and non-target lesions; Partial Response (PR): at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Results are reported as per age groups (<70 years, 70-80 years, and >80 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS. Here, number of participants analyzed = participants with available data for this outcome.|||percentage of participants|||Number
1420985|NCT01089413|Secondary|Progression-Free Survival (PFS)|PFS (in months) was defined as: (date of progression or censored date - first date of treatment + 1)/30.44. Date of progression was derived from Response Evaluation Criteria in Solid Tumors (RECIST) evaluation or from last available date for participant who withdrew the study for progressive disease without progression according to RECIST evaluation. Progression was defined (as per RECIST) as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and ≥70 years) as well as for overall participants.|Baseline up to disease progression or death (up to approximately 3 years)|FAS.|||months||95% Confidence Interval|Median
1420986|NCT01089413|Primary|Duration of Bevacizumab Treatment|Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus [+] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (<70 years and greater than or equal to [≥] 70 years) as well as for overall participants.|Baseline up to end of treatment (up to approximately 3 years)|FAS.|||months||95% Confidence Interval|Median
1420987|NCT01089361|Other Pre-specified|PCR Substudy|PCR analysis on serum samples for presence of bacterial and mitochondrial DNA; This substudy was not done.|Daily up to 7 days|Not done||||||
1420988|NCT01089361|Secondary|28 Day Mortality||28 days||||deaths|||Number
1420989|NCT01089361|Secondary|Length of Intensive Care Unit (ICU) Stay||28 days||||days||Standard Deviation|Mean
1420990|NCT01089361|Secondary|Acute Physiology and Chronic Health Evaluation (APACHE) Scores|Difference in average APACHE-II score between the intervention and placebo groups. APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity of disease classification system for patients admitted to the Intensive Care Unit. It uses an integer score from 0 to 71 that is computed based on age, 12 routine physiological measurements (i.e. heart rate, temperature, laboratory values), and previous health status obtained during the first 24 hours after ICU admission. Higher scores correspond to more severe disease and a higher risk of death.|First 24 hours after ICU admission||||APACHE score||Standard Deviation|Mean
1420991|NCT01089361|Secondary|Organ Failures|Incidence of new organ failure as detected by Sequential Organ Failure Assessment [SOFA] score. Definitions are as follows. Central nervous system: delirium, coma, uncontrollable seizures, ICP>20cm H2O Cardiac: MAP <60mmHg, blood pressure supported with pressors, 50 > HR > 120 Respiratory: vented, RR>30, PaO2<60, PaCO2 > 55, Sat<92% Kidney: RIFLE criteria Anemia: Hct<27, transfusion of PRBC Thrombocytopenia: platelet < 50k, platelet transfusion Liver: biopsy, ALT>200, AST>200, t.bil>2.0, ALP>300 Coagulation failure: INR>2 if no anticoagulation therapy|7 days||||participants with increase in SOFA score|||Number
1420994|NCT01089231|Secondary|Blood Lipids|Fasting venous blood samples were collected and blood lipid levels were determined by an external contract laboratory (LADR, Hannover; Germany) at baseline (t0), after one week (t1) and after 12 weeks (t12) of supplementation.|baseline and after 12 weeks||||mg/dl||Standard Deviation|Mean
1420995|NCT01089231|Secondary|Fatty Acid Composition of Erythrocyte Membranes (Omega-3 Index)|Fasting venous blood samples were collected and RBC membrane FA composition including the omega-3 index, given as EPA + DHA, was analyzed at baseline and after 12 weeks according to the omega-3 index methodology (Harris & von Schacky, 2004). Results are presented as a percentage of the total identified FAs after response factor correction. The coefficient of variation for EPA + DHA was 5%. Quality was assured according to DIN ISO 15189.|baseline and after 12 weeks||||percentage of total fatty acids||Standard Deviation|Mean
1420996|NCT01089231|Primary|Gene Expression Changes|Gene expression changes were measured by using whole genome microarrays. The expression values of all genes were compared between baseline and 4 hours, 7 days and twelve weeks after supplementation with FO or CO and differentially expressed genes were detected by standard two-state pooled-variance t-test (p<0,05). The number of differentially expressed genes (regulated genes)compared to the baseline values were determined for every study group in total as well as for every time point (4 hours, 7 days, 12 weeks)in total and specifically.|Gene expression changes (number of regulated genes)||||number of regulated genes|||Number
1420997|NCT01089127|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1420998|NCT01089127|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1420999|NCT01089062|Secondary|Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose|The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dose|Patients with available data at the required time point were included in the analysis population.|||milliseconds||Standard Deviation|Mean
1421000|NCT01089062|Secondary|Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods|Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure.|baseline, 10 minutes post 1st dose, 10 minutes post 2nd dose|Patients with available data at the required time point were included in the analysis population.|||mmHg||Standard Deviation|Mean
1421001|NCT01089062|Secondary|AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose|AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|4 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.|||mmHg*min||Standard Deviation|Mean
1421002|NCT01089062|Secondary|Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.|||mmHg||Standard Deviation|Mean
1421003|NCT01089062|Secondary|Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose|Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.|baseline and 2 hours from the time of first dose|Patients with available data at the required time point were included in the analysis population.|||percentage of participants|||Number
1421004|NCT01089062|Primary|AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose|AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.|2 hours from time of first dose|Patients with available data at the required time point were included in the analysis population.|||mmHg*min||Standard Deviation|Mean
1421005|NCT01089023|Secondary|Erythrocyte Sedimentation Rate|ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||mm/hr||Standard Deviation|Mean
1421006|NCT01089023|Secondary|C-Reactive Protein (CRP) Values by Study Visit|CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||mg/L||Standard Deviation|Mean
1421056|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to 336 h Postdose [AUC(0-336)] of Necitumumab After Multiple Doses|Steady state AUC(0-336) values are reported.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had AUC(0-336) values for Day 29 of Cycle 1.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1421007|NCT01089023|Secondary|HAQ-DI Score by Visit|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3..|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||scores on a scale||Standard Deviation|Mean
1421008|NCT01089023|Secondary|Percentage of Participants With Improvement in Physical Function by HAQ-DI Category|Physical function scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI <1), moderate disability (1≤ HAQ-DI <2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
1421009|NCT01089023|Secondary|Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
1421010|NCT01089023|Secondary|Time to DAS28 Response by DAS28 Category|Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 <2.6), or Clinically Meaningful Improvement (change of >1.2 from baseline).|Weeks 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||days||Standard Error|Mean
1421011|NCT01089023|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline.|Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
1421012|NCT01089023|Secondary|Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (>)5.1 indicated high disease activity, a score of >3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than <2.6 indicated disease remission. Week 24 is the Follow-Up visit.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|"All the participants who were administered treatment at each visit were considered during the analysis.~n (number) at Week 24 equals (=) number of participants in that visit; n at Other Visits = number of participants with treatment administered"|||percentage of participants|||Number
1421013|NCT01089023|Primary|Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events|Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.|Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24|All the participants who were administered treatment at each visit were considered during the analysis.|||percentage of participants|||Number
1421014|NCT01088997|Secondary|Change in Myocardial Performance Index (MPI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|An echocardiogram obtained while on milrinone was obtained with the goal of attempting to look for improvements in parameters associated with pulmonary hypertension. The primary parameter measured was the myocardial performance index (MPI). An Echocardiogram was performed at baseline (pre-infusion) and repeated 12-24 hours ater the initiation of the Milrinone infusion. Also known as the Tei index, the MPI is an index that incorporates both systolic and diastolic time intervals in expressing global systolic and diastolic ventricular function. Systolic dysfunction prolongs preejection (isovolumic contraction time, IVCT) and a shortening of the ejection time (ET). Both systolic and diastolic dysfunction result in abnormality in myocardial relaxation which prolongs the relaxation period (isovolumic relaxation time, IVRT). Normal value for MPI is 0.39+/-0.05 with dilated cardiomyopathy value of MPI at 0.59+/-0.10 (both units on a scale)|Up to 24 hours after start of infusion||||units on a scale||Standard Deviation|Mean
1421057|NCT01088464|Secondary|Immunogenicity (IK): Number of Participants With Treatment-Emergent Anti-IMC-11F8 Antibodies|Treatment-emergent samples were defined as samples which showed at least 4-fold difference (2 dilution increase) at post-baseline in IK titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|For Cohorts 1, 2 and 3: Prior to first infusions of Cycles 1, 2, and 4 and at the 30-day follow-up visit (+7 days) after the last dose of study drug|All participants who received any quantity of study drug.|||participants|||Number
1421015|NCT01088997|Primary|Define Plasma Concentration-time Profile of Milrinone in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN) - Clearance (CL, mL/Min)|The schedule of milrinone pharmacokinetic (PK) sampling varied by weight to minimize blood sampling. For babies weighing less than 3kg, samples were drawn at the end of the bolus, 15 minutes prior to the end of infusion (EOI) and 20 minutes, 1, 2, 6 and 12 hours after EOI. For babies weighing 3kg or more, samples were drawn at the end of the bolus, 6 hours after start of infusion, 15 minutes prior to the EOI and 30 minutes, 1, 3, 9 and 15 hours after EOI. Milrinone plasma concentrations were determined using a validated high-performance mass spectrometry assay.|End of bolus dose, 15 minutes prior to end of infusion (EOI), at four time points after EOI with final sample at 12-15 hours after EOI (timing based on infant's weight)|The pharmacokinetic analysis, including the primary outcome parameter, Clearance, was planned a priori to include all the participants pooled together. A PK analysis by arm wouldn't be appropriate. The randomization arms were only created to explore the secondary clinical and pharmacodynamic outcomes.|||mL/min/3.4 kg||Standard Error|Mean
1421016|NCT01088997|Secondary|Change in Oxygenation Index (OI) From Baseline to up to 24 Hours After Start of Milrinone Infusion|Oxygenation Index (mean airway pressure*Fraction of Inspired Oxygen/Partial Pressure of Oxygen in the blood) was calculated at baseline and every 6 hours after start of infusion until 12-24 hours after initiation of milrinone infusion.|for up to 24 hours after start of infusion|OI was calculated every 6 hours after start of infusion for 24 hours.|||units on a scale||Standard Deviation|Mean
1421017|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until 24 Hours After Study Drug Administration (AUC0-24) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1421018|NCT01088984|Secondary|Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until the Last Measurable Plasma Concentration (AUC0-t) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1421019|NCT01088984|Secondary|Time to Maximum Plasma Drug Concentration (Tmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||hours||Geometric Coefficient of Variation|Geometric Mean
1421020|NCT01088984|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Bendamustine and Its Metabolites (M3 and M4)||Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.|The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1421021|NCT01088984|Secondary|Duration of Response (DOR)|DOR was determined for the participants with CR or CRp in the primary analysis set, defined as the time from first achieving remission to the time when progression was diagnosed, the participant died, or the participant started receiving new antineoplastic therapy. Data from participants who do not progress were censored at the last valid assessments. Median DOR and its 95% confidence interval was determined based on the Kaplan-Meier method. Data from participants who received a transplant were censored at the time of the transplant.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|No duration of remission (defined as CR or CRp) analysis was performed for participants in the primary analysis since none achieved remission.||||||
1421022|NCT01088984|Secondary|Best Overall Tumor Response Rate, by Phase|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The safety analysis set included all participants treated at any dose of bendamustine.|||percentage of participants||95% Confidence Interval|Number
1421023|NCT01088984|Secondary|Best Overall Tumor Response Rate|Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.|At each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.|||percentage of participants||95% Confidence Interval|Number
1421024|NCT01088984|Primary|Overall Response Rate (ORR)|ORR was calculated as follows: number of participants in the primary analysis set achieving a best overall response of complete remission without platelet recovery (CRp) or complete remission (CR), divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A CR required no evidence of circulating blasts or extramedullary disease, an M1 marrow (≤ 5% bone marrow blasts), and recovery of peripheral counts (platelets ≥ 100 × 10^9/L and absolute neutrophil count ≥ 1.0 × 10^9/L). A CR without platelet recovery (CRp) required all of the criteria for a CR with the exception of platelet recovery.|Assessed at each treatment cycle (21 to 35 days), for a maximum of 12 cycles|The primary analysis set for efficacy included all participants treated at the RP2D in Phase 2.|||percentage of participants||95% Confidence Interval|Number
1421025|NCT01088984|Primary|Recommended Phase II Dose (RP2D) of Bendamustine|RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m^2 were explored, and escalation to 150 mg/m^2 would only occur if the 120 mg/m^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m^2 dose; de-escalation to the 60 mg/m^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.|Induction Cycle (21- to 35-day cycle)|All participants enrolled in Phase 1 of the study.|||mg/m^2|||Number
1421026|NCT01088711|Secondary|Plasma Glucose Concentration|Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.|||mg/dL||95% Confidence Interval|Least Squares Mean
1421027|NCT01088711|Secondary|WAA Total GLP-1 Concentration|WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.|||pmol/L||95% Confidence Interval|Least Squares Mean
1421028|NCT01088711|Secondary|WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration|Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.|Through 4 hours post dose on Day 21|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 4 hours post dose on Day 21 were pooled according to treatment. All participants who received omarigliptin or placebo are included.|||pmol/L||95% Confidence Interval|Least Squares Mean
1421029|NCT01088711|Secondary|Percent Inhibition of DPP-4 After Day 22|Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post dose on Day 22|No data from obese healthy participants (Panel A) were collected after pre-dose on Day 22. Therefore, data are presented only for obese T2D participants (Panel B) 168 hours post-dose on Day 22.|||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
1421030|NCT01088711|Secondary|Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15|Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.|168 hours post-dose on Day 15|Data from obese healthy participants (Panel A) and obese T2D participants (Panel B) 168 hours post-dose on Day 15 were pooled according to treatment. Predose data from Day 1 were missing from 2 participants.|||Percent DPP-4 inhibition||95% Confidence Interval|Geometric Mean
1421031|NCT01088711|Primary|Number of Participants Withdrawing From Study Therapy Due to an AE||Up to Day 22|AEs were monitored in all obese healthy (Panel A) and T2D (Panel B) participants who received omarigliptin 50 mg or placebo.|||Participants|||Number
1421032|NCT01088711|Primary|Number of Participants Experiencing an Adverse Event (AE)||Up to Day 36|AEs were monitored in all obese healthy (Panel A) and Type 2 diabetes (T2D) (Panel B) participants who received omarigliptin 50 mg or placebo.|||Participants|||Number
1421033|NCT01088672|Secondary|Mortality at 90 Days|All cause mortality through 90 days post procedure.|90-day||||participants|||Number
1421034|NCT01088672|Secondary|Clinical Outcomes at 90 Days|"Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.~mRS 0-2 indicates functional independence 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~https://en.wikipedia.org/wiki/Modified_Rankin_Scale"|90-day||||percentage of subjects with mrs 0-2|||Number
1421085|NCT01087996|Secondary|Change in Minnesota Living With Heart Failure Total Score|The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months||||units on a scale||95% Confidence Interval|Mean
1421035|NCT01088672|Primary|Revascularization Status|"Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure~Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.~Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...~Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]"|Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment||||percentage of subjects TICI 2 or >|||Number
1421036|NCT01088646|Primary|Percentage of Capsule Placement Success Using PillCam® Express Capsule Endoscopy Delivery System||up to 7 days|||||||
1421037|NCT01088646|Primary|Number of Participants With Successful Capsule Placment Into the Duodenum Using Capsule Delivery System|The number of capsules that successfully were in the duodenum as indicated by video images|up to 7 days||||participants|||Number
1421038|NCT01088529|Secondary|Number of Participants With Prostate-Specific Antigen Response|The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.|Cycle 3 Day 1|"Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||participants|||Number
1421039|NCT01088529|Secondary|Number of Participants With a Positive Surgical Margin at Radical Prostatectomy|The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.|||participants|||Number
1421040|NCT01088529|Primary|Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)|The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.|At the end of Cycle 3 (at radical prostatectomy)|Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.|||participants|||Number
1421041|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index|The Duke CAD Index is a validated composite measure of angiographic burden, which assigns prognostic weights 1 through 100. Higher scores indicate greater angiographic burden and are associated with poorer prognosis.|Day 0 (study enrollment)|All enrolled participants who had Duke CAD Index completed.|||units on a scale||Standard Deviation|Mean
1421042|NCT01088503|Primary|Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin||Day 0 (study enrollment)|All enrolled participants who had pre-procedure hemoglobin evaluation.|||grams/deciliter (g/dL)||Standard Deviation|Mean
1421043|NCT01088503|Secondary|Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness||15 months|Zero participants were analyzed. Exploratory analysis of resource use patterns, cumulative total medical costs, and cost effectiveness was dependent on effectiveness in the primary outcome. As there was no effectiveness on the primary outcome demonstrated, no analysis of these outcome measure was conducted.||||||
1421044|NCT01088503|Secondary|Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events|Academic Research Consortium (ARC) criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least 1 of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with ST events are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a definite or probable ST event.|Baseline through 15 months|Participants who were treated with prasugrel or clopidogrel.|||percentage of participants||95% Confidence Interval|Number
1421045|NCT01088503|Secondary|Percentage of Participants With MACE Over 1, 6 and 15 Months|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE are presented. Kaplan-Meier analysis was used to estimate the percentage of participants with a MACE event.|Baseline through 1, 6 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
1421046|NCT01088503|Secondary|Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years|MACE is defined as a composite of all-cause death, MI, stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participant = (number of participants with events / number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
1421086|NCT01087996|Secondary|Change in Distance Walked in 6-minutes From Baseline.||12-months||||meters||95% Confidence Interval|Mean
1421087|NCT01087996|Secondary|CT Measure of Scar Size as % of LV Mass||Baseline Month 13 post-catheterization||||percent||95% Confidence Interval|Mean
1421088|NCT01087996|Secondary|CT Measure of End Systolic Volume||Baseline Month 13 post-catheterization||||ml||95% Confidence Interval|Mean
1421089|NCT01087996|Secondary|CT Measure of End Diastolic Volume||Baseline Month 13 post-catheterization||||ml||95% Confidence Interval|Mean
1421047|NCT01088503|Secondary|Percentage of Participants With Cumulative Severe or Moderate Bleeding Events|Bleeding events were collected utilizing the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition of bleeding. Non-coronary artery bypass grafting (CABG)-related GUSTO severe or life-threatening bleeding is any intracranial hemorrhage (ICH) OR any bleeding event resulting in substantial hemodynamic compromise requiring treatment. Non-CABG-related GUSTO moderate bleeding is any bleeding event resulting in the need for transfusion that is not considered a GUSTO severe or life-threatening bleed. Additional bleeding events are fatal bleeding or ICH, or any non -fatal surgical-related bleeding events leading to ≥4 units of red cell transfusion. Observed (unadjusted) percentages of participants with bleeding events, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events / number of participants treated) * 100.|Baseline, 1, 6, 12 and 15 months|Participants who were treated with prasugrel or clopidogrel. Participants with bleeding events dated prior to index PCI were excluded from the analysis. The analysis was based on the initial treatment assignment, regardless of whether or not the participants switched or discontinued that treatment.|||percentage of participants||95% Confidence Interval|Number
1421048|NCT01088503|Primary|Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment|Factors are drug-eluting stent (DES) vs. bare metal stent (BMS) placement, other (no stent) vs. BMS, STEMI, other race, cardiogenic shock occurred within 24 hours, male, European Quality of Life Questionnaire-5 Dimension Health State Score (EQ-5D) - United States (US) Index =1 vs. <1, married, diabetes, and other vs. BMS placement. The EQ-5D US index is a participant-rated, health-related, quality-of-life instrument based on US population. Scores range from -0.11 to 1.0 with 1.0 = perfect health.|Day 0 (study enrollment)|All enrolled participants|||participants|||Number
1421049|NCT01088503|Primary|Percentage of Participants With Major Adverse Cardiovascular Events (MACE)|MACE is defined as a composite of all-cause death, myocardial infarction (MI), stroke, or unplanned coronary revascularization. Events that occurred more than 7 days after medication was switched or discontinued were excluded from the analysis. Observed (unadjusted) percentages of participants with MACE, as well as the statistical analyses adjusted for baseline cohort differences, are presented. Percentage of participants = (number of participants with events in 12 months/ number of participants treated) * 100.|Baseline through 12 months|Participants who were treated with prasugrel or clopidogrel. Participants with MACE events dated prior to index PCI were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
1421050|NCT01088464|Primary|PK: Vss of Necitumumab After Multiple Doses|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Data did not allow calculation of Vss for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Vss values for Day 29 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.|||mL||Geometric Coefficient of Variation|Geometric Mean
1421051|NCT01088464|Primary|PK: Steady-State Volume of Distribution (Vss) of Necitumumab After Single Dose|Vss is that amount of plasma in which the study drug needs to be dissolved to attain a steady state drug concentration. Vss was not analyzed for participants in Cohorts 1 and 3 as Vss is derived from AUC (0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Vss values for Day 1 of Cycle 1. Vss of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.|||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
1421052|NCT01088464|Primary|PK: CL of Necitumumab After Multiple Doses|CL is defined as the volume of plasma that is cleared of study drug per unit time. Data did not allow calculation of CL for participants in Cohorts 1 and 3.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had CL values for Day 29 of Cycle 1. CL of necitumumab was not assessed for participants in Cohorts 1 and 3, due to the irregular dosing regimen.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
1421053|NCT01088464|Primary|PK: Clearance (CL) of Necitumumab After a Single Dose|CL is defined as the volume of plasma that is cleared of study drug per unit time. CL was not analyzed for participants in Cohorts 1 and 3 as CL is derived from AUC(0-∞). AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received single dose of study drug and had CL values for Day 1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for CL on Day 1 of Cycle 1, due to fraction of data outside tlast >30%|||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1421054|NCT01088464|Primary|PK: t½ of Necitumumab After Multiple Doses|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All the participants who received multiple doses of study drug and had t½ values for Day 29 of Cycle 1.|||h||Geometric Coefficient of Variation|Geometric Mean
1421055|NCT01088464|Primary|PK: Half-Life (t½) of Necitumumab After a Single Dose|The t½ is defined as the time taken for study drug in blood to decrease to half of its concentration.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had t½ values for Day 1 of Cycle 1.|||h||Geometric Coefficient of Variation|Geometric Mean
1421058|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of Necitumumab After a Single Dose|AUC(0-∞) was calculated only for participants in Cohort 2 as the percentage of AUC extrapolated beyond tlast was greater than 30% for all the remaining participants.|Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|"All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day~1 of Cycle 1. No participant of Cohorts 1 and 3 were analyzed for AUC(0-∞) on Day 1 of Cycle 1, due to fraction of data outside tlast >30%"|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1421059|NCT01088464|Primary|PK: Area Under the Concentration-Time Curve From Time 0 to Last Time Point [AUC (0-tlast)] of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 h after end of infusion. Cohort 2: predose, immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had evaluable AUC(0-∞) values for Day 1 of Cycle 1.|||micrograms*hour/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1421060|NCT01088464|Primary|PK: Cmin of Necitumumab After Multiple Doses|Cmin was calculated prior to the last dose of the initial 6-week treatment cycle.|Cycle 1; Cohorts 1and 3: prior to fourth infusion. Cohort 2: prior to third infusion|All participants who received multiple doses of study drug and had Cmin serum concentrations prior to last dose of Cycle 1.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1421061|NCT01088464|Primary|PK: Minimum Concentration (Cmin) of Necitumumab After a Single Dose|Cmin is defined as the minimum concentration the drug achieved after administration of first infusion and prior to the administration of second infusion.|Cycle 1; Cohorts 1, 2 and 3: prior to second infusion|All participants who received single dose of study drug and had Cmin serum concentrations analyzed prior to administration of second dose.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1421062|NCT01088464|Primary|PK: Cmax of Necitumumab After Multiple Doses|Cmax at steady state (after the last dose of the initial 6-week treatment cycle).|Cycle 1, Day 29; For Cohorts 1, 2 and 3: predose (prior to fourth infusion for Cohorts 1 and 3; prior to third infusion for Cohort 2), immediately after end of infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received multiple doses of study drug and had Cmax values for Day 29 of Cycle 1.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1421063|NCT01088464|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of Necitumumab After a Single Dose||Cycle 1, Day 1; Cohorts 1 and 3: predose, immediately after end of infusion, 0.5, 1, 2, 6, 24, 96 and 168 hours (h) after end of infusion. Cohort 2: predose, immediately after infusion, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 h after end of infusion|All participants who received single dose of study drug and had Cmax values for Day 1 of Cycle 1.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1421064|NCT01088464|Primary|Number of Participants With 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Data presented are the number of participants who experienced 1 or more TEAEs or SAEs regardless of causality. An adverse event was considered as TEAE if it occurred any time after the administration of the first dose of study drug or up to 30 days after the last dose of study treatment or if it occurred prior to the first dose and worsened while on treatment. A summary of SAEs and other non-SAEs regardless of causality is located in the Reported Adverse Events module.|Baseline up to 24 weeks plus 30 days post last dose of study drug|All participants who received any quantity of study drug.|||participants|||Number
1421065|NCT01088438|Primary|Probing for Biomedical Issues|Probability that the learner probes biomedical red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a biomedical red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT|||proportion of encounters|Participants|95% Confidence Interval|Number
1421066|NCT01088438|Primary|Probing for Contextual Issues|Probability that the learner probes contextual red flags raised in standardized patient encounters undertaken at assessment at end of subinternship. Each learner undertakes four encounters, each of which presents a contextual red flag that may or may not be probed; in a small number of cases, the standardized patient was ill and the learner undertook fewer than four encounters as a result. Assessment of probing is made by an investigator blinded to learner's assignment to group.|1 month|ITT|||proportion of encounters|Participants|95% Confidence Interval|Number
1421067|NCT01088438|Primary|Developing an Appropriate Treatment Plan (for Contextual Variant of Encounters)|Probability that the learner writes a correct treatment plan for the standardized patient encounters undertaken at assessment at end of subinternship that include contextual red flags. All learners are scheduled to see 4 encounters, based on combinations of four cases and four potential variants (baseline, biomedical, contextual, biocontextual) with counterbalancing by study month; each has a single contextual variant encounter. Treatment plans are assessed by an investigator blinded to the learner's assignment to intervention or control group.|1 month|ITT. In one case, a participant did not receive a contextual variant encounter because the standardized patient was ill, and this encounter is excluded.|||proportion of contextual encounters|Participants|95% Confidence Interval|Number
1421068|NCT01088399|Other Pre-specified|Number of Participants Who Died While in the Study||Study enrollment up to approximately 10 years|All participants with baseline and at least 1 post-baseline visit.|||participants|||Number
1421090|NCT01087996|Secondary|CT Measure of Left Ventricular Ejection Fraction||Baseline Month 13 post-catheterization||||percent||95% Confidence Interval|Mean
1421091|NCT01087996|Secondary|CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month|Percentage change from 13-months post-catheterization to baseline.|Baseline Month 13 post-catheterization||||percent change from baseline||95% Confidence Interval|Mean
1421092|NCT01087996|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||One month post-catheterization||||percentage of participants||95% Confidence Interval|Number
1421069|NCT01088399|Secondary|Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).|QLS-H is a self-administered, weighted, quality of life (QoL) questionnaire consisting of 9 items developed for participants with growth hormone deficiency. Scores were corrected for age, gender, and country differences, and expressed as Z-scores based on country-specific reference ranges. Participants indicate how important a certain dimension of QoL is to them and are then questioned as to their degree of satisfaction with that dimension. Each item is rated on a 5-point Likert scale ranging from not important (1) to extremely important (5) and from dissatisfied (1) to very satisfied (5). The weighted score for the degree of satisfaction (weighted satisfaction) with a particular dimension=(importance - 1)x(2 x satisfaction - 5). Total Z-score is obtained by adding the individual item scores of the 9 dimensions, and range from -108 (representing very low satisfaction) to +180 (representing very high satisfaction).|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and has a Total Z Score.|||Z-score||Standard Deviation|Mean
1421070|NCT01088399|Secondary|Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)||Baseline through 10 years|All participants with baseline and at least 1 post-baseline visit and who provided bone fracture information.|||percentage of participants|||Number
1421071|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Waist Circumference|Change in waist circumference was used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had waste circumference data.|||centimeters (cm)||Standard Deviation|Mean
1421072|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides|Change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides were used as an indicator of cardiovascular risk and are presented.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had cholesterol or triglyceride data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1421073|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)|Change in SBP and DBP were used as an indicator of cardiovascular risk.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and BP data.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1421074|NCT01088399|Secondary|Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)|Change in BMI was used as an indicator of cardiovascular risk. Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.|Baseline, interim time point (5 years), and study completion (10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated) and had BMI data.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
1421075|NCT01088399|Primary|Clinically Significant Adverse Events|A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.|Baseline to study completion (approximately 10 years)|All participants with baseline and at least 1 post-baseline visit whose study therapy was known (treated or untreated).|||percentage of participants|||Number
1421076|NCT01088295|Secondary|Safety and Tolerability of Telmisartan||24 weeks|||||||
1421077|NCT01088295|Primary|Median Change in Visceral Adipose Tissue (VAT) Volume|VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography|Baseline and 24 weeks|as-treated analysis|||cm^2||Inter-Quartile Range|Median
1421078|NCT01088243|Secondary|Lung Function|Secondary outcomes include changes in lung function, which will be assessed with Forced expiratory volume in 1 second percent predicted (FEV1), Forced vital capacity percent predicted (FVC) and Diffusing capacity percent predicted (DLCO).|baseline and week 6|One participant did not complete follow up in Mesalamine group. However, below is a summary of what data was received.|||percentage of predicted value||Standard Deviation|Mean
1421079|NCT01088243|Secondary|Glucocorticoid Receptors|Secondary outcomes include changes in glucocorticoid receptors modification in PBMCs and BAL cells.|baseline and week 6|We were not able to perform due to insufficient samples and data collected from each participant to summarize changes.||||||
1421080|NCT01088243|Secondary|HDAC2 Levels|Secondary outcomes include changes in HDAC2 levels|baseline and week 6|We were not able to perform due to insufficient samples and data collected from each participant to summarize changes in HDAC2 levels.||||||
1421081|NCT01088243|Secondary|Changes in Steady-state Glutathione (GSH) Levels From Baseline to Week 6|Secondary outcomes include changes in steady-state GSH levels in beryllium specific CD4+ T cell in bronchoalveolar lavage fluid (BALF)|baseline and week 6|We did not receive enough cells from participants to be able to run experiments on all. However, below is a summary of what data was received.|||mmol/mg||Standard Deviation|Mean
1421082|NCT01088243|Secondary|Changes in Bronchoalveolar Lavage (BAL) Tumor Necrosis Factor Alpha (TNFa)|Secondary outcomes include changes in bronchoalveolar lavage (BAL) tumor necrosis factor alpha (TNFa)|baseline and week 6|We did not have sufficient cells to run experiments on all participants. However, below is a summary of what data was received.|||pg/ml||Standard Deviation|Mean
1421083|NCT01088243|Primary|Change in Beryllium Lymphocyte Proliferation Responses (BeLPT) From Baseline to Week 6|"Primary endpoints are beryllium proliferation responses (BeLPT) in PBMCs (peripheral blood mononuclear cells) and BAL (bronchoalveolar lavage) cells. The BeLPT is a blood test that measures the immune response to beryllium exposure. If immune cells multiply in response to beryllium, this is considered an abnormal test results. If immune cells do not multiple, this is considered a normal test results. Results are reported as stimulation index, which is a ratio of the number of cells grown with beryllium compared to the number of cells grown without beryllium. A value of 2.5 or less is considered normal, and a value greater than 2.5 is abnormal."|baseline and week 6|Because bronchoscopy was not required for participation, only three placebo and six 5-ASA-treated subjects underwent bronchoscopy and is reported under BAL.|||Stimulation index||Standard Deviation|Mean
1421084|NCT01087996|Secondary|Change in New York Heart Association Class at 12-months||12 months||||participants|||Number
1421093|NCT01087970|Other Pre-specified|Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)|Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.|From enrollment to 30 days post-treatment discontinuation up to 26.4 months|All enrolled participants who received at least 1 dose of any study drug.|||participants|||Number
1421094|NCT01087970|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: normalcy of diet (NOD) subscale measures the ability of the participants to eat a normal diet, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant’s speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant’s response to the questions of whom he/she eats with and in what setting, subscale ranges from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.|||units on a scale||Standard Deviation|Mean
1421095|NCT01087970|Secondary|Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant’s rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)|All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.|||units on a scale||Standard Deviation|Mean
1421096|NCT01087970|Secondary|Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)|PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)|All treated participants excluding those from a noncompliant study site.|||percentage of participants||95% Confidence Interval|Number
1421097|NCT01087970|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.|From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.|||months||95% Confidence Interval|Median
1421098|NCT01087970|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)|All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.|||months||95% Confidence Interval|Median
1421099|NCT01087957|Secondary|Berg Balance Scale|The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|6 months||||units on a scale||Standard Error|Mean
1421100|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Stair Time|The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .|6 months||||seconds||Standard Error|Mean
1421101|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Obstacle Course|The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.|6 months||||seconds||Standard Error|Mean
1421102|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Timed up and Go|The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.|6 months||||seconds||Standard Error|Mean
1421103|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Carpet Time|The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .|6 months||||seconds||Standard Error|Mean
1421104|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Floor Time|The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.|6 months||||seconds||Standard Error|Mean
1421105|NCT01087957|Secondary|Modified Emory Functional Ambulation Profile Total Score|The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up & Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.|6 months||||seconds||Standard Error|Mean
1421106|NCT01087957|Secondary|Six Minute Walk Test||6 months||||meters||Standard Error|Mean
1421107|NCT01087957|Primary|Device Related Serious Adverse Events|The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).|6 months|Intention to treat|||number of device related SAEs|||Number
1421108|NCT01087957|Primary|Stroke Impact Scale (SIS) Composite Score|The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.|6 months|Intention to treat|||points||Standard Error|Mean
1421109|NCT01087957|Primary|Gait Velocity|Improved ambulation status, specific to increase in gait velocity (m/s)|6 months|Intention to treat|||m/sec||Standard Error|Mean
1421110|NCT01087944|Secondary|Number of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Upto Day 36|The ITT population included all participants who received at least one injection|||participants|||Number
1421111|NCT01087944|Secondary|Number of Participants With Abnormalities in Electrocardiograms|A 12-lead ECG was recorded after the participant had been in a semi-supine position for at least 10 minutes. Any clinically significant abnormalities noted on an ECG after the first dose of study drug were captured as AEs|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421112|NCT01087944|Secondary|Number of Participants With Abnormalities in Pulse Rate, Temperature, and Blood Pressure|The pulse rate, temperature and blood pressure was assessed during a physical examination. Pulse rate was assessed in beats per minute (bpm), temperature was assessed in degree Celsius (°С), and blood pressure was assessed in millimeters of mercury (mmHg). Vital signs were taken while the participant was supine.|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421113|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Creatinine|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Creatinine was 0- 154 (micromoles/liter [umol/L]). The clinical relevant change (decrease/ increase) for Creatinine was (n.d, 50%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421114|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Blood Urea Nitrogen (BUN), Chloride, Potassium, Sodium, Calcium, Glucose|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for BUN was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 2.9-5.8 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), and Glucose was 2.80-11.10 (mmol/L). The clinical relevant change (decrease/ increase) for BUN was (n.d, 50%), Chloride was (7%, 7%), Potassium was (20%, 20%), Sodium was (7%, 7%), Calcium was (10%, 10%), and Glucose was (75%, 75%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421115|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic-Pyruvic Transaminase (SGPT), and Alkaline Phosphatase|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for SGOT was 0-80 (Units Per Litre [U/L]), SGPT was 0-110 U/L, and alkaline phosphatase was 0-220 U/L. The clinical relevant change (decrease/ increase) for SGOT was (n.d, 50%), SGPT was (n.d, 50%), and ALP was (n.d, 50%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421278|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421116|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Prothrombin Time (PT) International Normalized Ratio (INR)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for PT-INR was n.d.-2.00. The clinical relevant change (decrease/ increase) for PT-INR was (n.d, 30%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421117|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Right Blood Cell (RBC)|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for RBC was 3.80-6.10 (10*12/L). The clinical relevant change (decrease/ increase) for RBC was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421118|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell (WBC), Basophil, Eosinophil, Lymphocyte, Monocyte and Neutrophil|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for Platelets was 100-550 (10*9/L), for WBC was 3.0-18.0 (10*9/L), for Basophils was 0.00-0.40 (10*9/L), for Eosinophil was 0.00-0.90 (10*9/L), for Lymphocytes was 0.70-7.60 (10*9/L), Monocyte was 0.00-1.70 (10*9/L), and Neutrophil 1.50-9.25 (10*9/L). The clinical relevant change (decrease/increase) for platelet was (30%, 50%), WBC was (30%, 30%), Basophil was (n.d, 100%), Eosinophil was (n.d, 100%), Lymphocyte was (30%, 30%), Monocyte was (n.d, 100%) and Neutrophil was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421119|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hematocrit|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hematocrit was 0.31-0.56 fraction. The clinical relevant change (decrease/ increase) for hematocrit was (15%, 15%).|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421120|NCT01087944|Secondary|Number of Participants With Marked Laboratory Abnormalities in Hemoglobin, Albumin and Total Protein|A marked abnormality was defined as a test result which was outside of the marked abnormality range, and which represented a clinically relevant change from baseline of at least the designated amount. The marked reference range for hemoglobin was 110-200 (gram per liter [g/L]), albumin was 30.0-n.d g/L, and total protein was 55-87 g/L. The clinical relevant change (decrease/ increase) for hemoglobin was (15%, 15%), albumin was (20%, n.d) and total protein was (20%, 20%) respectively.|Week 1, Day 1 (Baseline), Week 4 (Day 22 ± 2 days), and Week 6 (Day 36 ± 2 days)|The ITT population included all participants who received at least one injection|||participants|||Number
1421121|NCT01087944|Primary|Feasibility of Peginterferon Alfa-2a Administration by Autoinjector|The feasibility of PEG-INF administration by AI was assessed by Injection Method Observational Survey questions, based on following pre-defined questions using a “Yes” or “No” response: 1) Did the participant exhibit any nervousness prior to the injection? 2) Did the participant exhibit any difficulty initiating the injection? 3) Did the participant appear confident performing the injection? 4) Did the participant follow the instructions for performing the injection without the need for additional instructions or guidance? 5) Did the participant experience any technical problems with the device or syringe during the injection? 6) Did the participant withdraw the device/syringe before the injection was complete? 7) Did the participant exhibit any visible pain or physical discomfort? 8) Did the participant appear to be satisfied using the device or syringe? 9) Did the participant exhibit any frustration using the syringe or device?|Week 1, Day 1 (Baseline), Week 2 (Day 8 ± 2 days), Week 3 (Day 15 ± 2 days), Week 4 (Day 22 ± 2 days), Week 5 (Day 29 ± 2 days), Week 6 (Day 36 ± 2 days)|The intent-to-treat (ITT) population included all participants who received at least one injection|||participants|||Number
1421122|NCT01087931|Secondary|Narcotic Use, Final Follow up|Number of participants using narcotics for pain|about 18 to 20 weeks after surgery||||Participants|||Count of Participants
1421123|NCT01087931|Secondary|Narcotic Use, 1st Follow up|Number of participants using narcotics for pain|about 4 to 5 weeks after surgery||||Participants|||Count of Participants
1421124|NCT01087931|Primary|Pain, Cumulative Visual Analog Score, Final Follow up|Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.|about 18 to 20 weeks after surgery|Original study data has been lost. Estimated values obtained from a figure describing the results in the study results publication are reported in the data table.|||units on a scale||Standard Deviation|Mean
1421125|NCT01087931|Primary|Pain, Cumulative Visual Analog Score, 1st Follow Up|Cumulative Visual Analog Score pain score scores were calculated using the sum of scores (at rest and with movement, pain on average at rest and with movement, and maximum pain at rest and with movement) Range = 0-60 for cumulative visual analog pain score with 0=no pain and 60=worst pain ever.|about 4 to 5 weeks after surgery||||units on a scale||Standard Deviation|Mean
1421126|NCT01087918|Secondary|Figure of Eight Test|The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||meters per second||Standard Deviation|Mean
1421127|NCT01087918|Primary|10 Meter Walking at Maximal Speed|The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||meters per second||Standard Deviation|Mean
1443817|NCT00905515|Primary|Renal Function in Patients Converted From Cyclosporine to Prograf||6 months, 1 year, 2 years and 3 years||||Change in serum creatinine (mg/dL)||Full Range|Mean
1421128|NCT01087918|Secondary|Falls Efficacy Scale|The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
1421129|NCT01087918|Secondary|Response Time of the Lower Extremities|We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)||||milliseconds||Standard Deviation|Mean
1421130|NCT01087918|Secondary|Pain on a Visual Analogue Scale|Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)|Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.|||units on a scale||Standard Deviation|Mean
1421131|NCT01087918|Secondary|Manual Muscle Test of the Lower Extremity|With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
1421132|NCT01087918|Secondary|Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis|Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.|Baseline, after intervention (4 weeks)||||milliseconds||Standard Deviation|Mean
1421133|NCT01087918|Secondary|Spinal Cord Independence Measure III|The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
1421134|NCT01087918|Secondary|Berg Balance Scale|The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
1421135|NCT01087918|Secondary|Walking Index for Spinal Cord Injury II|The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||units on a scale||Standard Deviation|Mean
1421136|NCT01087918|Primary|10 Meter Walking at Preferred Speed|The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed [m/s]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.|Baseline, after intervention (4 weeks)||||meters per second||Standard Deviation|Mean
1421137|NCT01087905|Secondary|Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group|For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.|26 weeks after the target quit smoking date|"No a priori power analysis was conducted for this secondary outcome."|||U.S. Dollars|||Number
1421138|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.|||Percentage of participants not smoking|||Number
1421139|NCT01087905|Primary|7-Day Point Prevalence Abstinence From Smoking by Intervention|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.|26 weeks after the target quit smoking date|The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.|||Percentage of participants not smoking|||Number
1421140|NCT01087814|Primary|Serum Levels of Efavirenz|Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz.|5th day of taking drug||||ng/mL||Standard Deviation|Mean
1421141|NCT01087801|Primary|Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).|Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.|First 5 minutes after treatment administration||||Participants|||Number
1432357|NCT00993291|Primary|Change in Stride Length From Baseline|Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length|1 hour||||CM||Full Range|Mean
1421142|NCT01087801|Primary|Endoscopic Sample|"Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8).~(Note- The outcome value is boolean (yes or no) as an answer)."|First 5 minutes after treatment administration|||||||
1421143|NCT01087788|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 48|"Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome).~For the analysis of this outcome measure, the change from Baseline to Week 48 was imputed using the median change from Baseline among all subjects for those subjects, which had less than 2 radiographs. The post-hoc analysis presented here is based on the subgroup of subjects which had a Baseline mTSS value greater than 6."|From Baseline to Week 48|Randomized Set (RS) with imputation: for subjects who withdrew for any reason, or subjects with missing Week 48 measurements, and for all placebo subjects after the switch to CZP, Week 48 scores are linearly extrapolated from the last two available radiographs prior to early withdrawal or Week 24 or before receiving CZP.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421144|NCT01087788|Secondary|Psoriasis Area Severity Index (PASI75) Response at Week 24 in the Subgroup of Subjects With Psoriasis (PSO) Involving at Least 3 % Body Surface Area (BSA) at Baseline|The PASI75 response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement.|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
1421145|NCT01087788|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 24|The HAQ-DI is a measure of function in Arthritis. There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance). The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline. The higher the negative value, the higher the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421146|NCT01087788|Secondary|American College of Rheumatology 20 (ACR20) Response at Week 24|ACR20 responders are those subjects with at least 20 % improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
1421147|NCT01087788|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) in Modification for Psoriatic Arthritis at Week 24|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 64 and 52 joints, respectively, with higher scores representing greater damage. mTSS (bone erosions) ranges from 0 (best possible outcome) to 320 (worst possible outcome); mTSS (joint space narrowing) ranges from 0 (best possible outcome) to 208 (worst possible outcome); and total score ranges from 0 (best possible outcome) to 528 (worst possible outcome). For the pre-defined analysis of this outcome measure, 0 was used for Baseline and the maximum observed mTSS value was used for Week 24 for those subjects which had less than 2 radiographs. The re-analysis is restricted to those subjects in the Randomized Set who have at least 2 x-ray values at scheduled visits, which are at least 8 weeks apart.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with imputation: for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, scores are linearly extrapolated from the last two radiographs prior to early withdrawal or Week 24 or before receiving CZP.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421148|NCT01087788|Primary|American College of Rheumatology 20 (ACR20) Response at Week 12|ACR20 responders are those subjects with at least 20 % improvement from Baseline (BL) for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS).|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as nonresponders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
1421279|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421149|NCT01087762|Secondary|Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12|The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 140 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1421150|NCT01087762|Secondary|Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12|The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation.|From Baseline to Week 12|The analysis was performed in the Magnetic Resonance Imaging (MRI) Set, a subgroup of subjects participating in an imaging substudy, where MRI measurements at Baseline and Week 12 were performed. Of the 325 patients randomized, 153 participated in the imaging substudy. Of these 153 subjects in the MRI Set, 148 are included in this analysis.|||units on a scale||Standard Deviation|Mean
1421151|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24|The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421152|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12|The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient’s limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421153|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421154|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421180|NCT01087502|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%|The percentage of patients with an HbA1c reduction of ≥0.5% at week 12 and week 52 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline, week 12 and week 52|FAS with non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.|||percentage of patients|||Number
1421155|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 24 measurements, or placebo subjects who used escape medication, last observation prior to early withdrawal or Week 24 or before receiving CZP is carried forward to Week 24.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421156|NCT01087762|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12|The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 (“Easy”) to 10 (“Impossible”). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|From Baseline to Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with Last Observation Carried Forward (LOCF): for subjects who withdrew for any reason, or subjects with missing Week 12 measurements, last observation prior to the early withdrawal or Week 12 is carried forward to Week 12.|||units on a scale||95% Confidence Interval|Least Squares Mean
1421157|NCT01087762|Secondary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:~Patient's Global Assessment of Disease Activity~Pain assessment (total spinal pain)~Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))~Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)~and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 24|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
1421158|NCT01087762|Primary|Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12|"The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains:~Patient's Global Assessment of Disease Activity~Pain assessment (total spinal pain)~Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI))~Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration)~and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit)."|Week 12|Intention-to-treat dataset was the Randomized Set (RS). RS with non-responder imputation: subjects who withdrew for any reason or placebo subjects who used escape medication are considered as non-responders from drop out timepoint or when escape therapy was initiated. Subjects with missing data at a visit are non-responders for that visit, too.|||percentage of participants||95% Confidence Interval|Number
1421159|NCT01087736|Other Pre-specified|PTSD Symptom Severity|The average PTSD symptom severity score during treatment (weeks 4, 8, 12). The PTSD Checklist (PCL) is a self-report measure of the 17 DSM-IV symptoms of PTSD. Respondents rate on a scale from 1 (not at all) to 5 (extremely) how much they were bothered by each symptom in the past month. A total symptom severity score (range = 17 - 85) can be obtained by summing the scores from the 17 items, with higher scores indicating greater severity of PTSD symptoms. Mean scores may be calculated for subscales of intrusion (range 5-25), avoidance (range 7-35), and arousal (range 5-25).|Weeks 4, 8, 12||||units on a scale||Standard Deviation|Mean
1421160|NCT01087736|Primary|Percent Drinking Days (%DD)|"Alcohol consumption was assessed at baseline and weekly during the treatment phase (12 weeks) using the Time Line Follow Back (TLFB) interview which yields number of days of alcohol use (DD).~DD: day on which alcohol was consumed Standard alcoholic drink defined as containing 13.6 g of pure alcohol."|Weekly, weeks 1-12, average||||percent days in a week||Standard Deviation|Mean
1421161|NCT01087723|Secondary|The Incidence of Stroke|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421162|NCT01087723|Secondary|The Incidence of Thrombocytopenia|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421163|NCT01087723|Secondary|The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421178|NCT01087528|Primary|Sensitivity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category .The false negative rate is equal to 1 - sensitivity and indicated the percentage of polyps missed by capsule endoscopy.|within 7 days||||percentage of participants||95% Confidence Interval|Number
1421164|NCT01087723|Secondary|The Incidence of Minor Bleeding: TIMI and GUSTO|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421165|NCT01087723|Secondary|The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421166|NCT01087723|Secondary|The Incidence of Death at 1 Year|Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time.|Within 1 Year|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421167|NCT01087723|Secondary|The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR)|Incidence=number of participants to experience the event/total number of at risk participants x 100. Death from any cause at any time. Re-infarction was a positive diagnosis of re-infarction not associated with index PCI. Non-CABG major bleeding was any 1 of: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. IDR was any refractory ischemia-driven repeat percutaneous intervention or bypass graft surgery involving any native coronary or pre-existing bypass graft vessel. In the absence of pain, new ST segment changes indicative of ischemia, acute pulmonary edema, ventricular arrhythmias, or hemodynamic instability presumed to be ischemic in origin, will constitute sufficient evidence of ischemia.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421168|NCT01087723|Secondary|The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding|A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421169|NCT01087723|Primary|The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding|A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion.|Within 30 days|Participants who were randomized and signed an ICF; ITT population|||percentage of participants|||Number
1421170|NCT01087541|Secondary|Systolic and Diastolic Blood Pressure||6 months||||mmHg||Standard Deviation|Mean
1421171|NCT01087541|Secondary|Blood Pressure ( Systolic / Diastolic )||Baseline||||mmHg||Standard Deviation|Mean
1421172|NCT01087541|Primary|Glycosylated Haemoglobin A1c at 6 Months|Glycohemoglobin A1c at 6 months.|6 months||||Percentage||Standard Deviation|Mean
1421173|NCT01087541|Secondary|BMI at 6 Months||6 months||||kg/m2||Standard Deviation|Mean
1421174|NCT01087541|Secondary|BMI ( Body Mass Index ) at Start||Baseline||||kg/m2||Standard Deviation|Mean
1421175|NCT01087541|Primary|Glycosylated Haemoglobin A1c at Start||Baseline||||Percentage||Standard Deviation|Mean
1421176|NCT01087528|Secondary|Percent of Participants With Scoring Index 3 or 4|"Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:~poor cleansing level (Large amount of fecal residue.)~fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)~good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)~excellent cleansing level (No more than small bits of adherent feces.)"|within 7 days|||||||
1421177|NCT01087528|Primary|Specificity of Capsule Endoscopy for Indicated Polyps|Readings of videos from the PillCam COLON were performed by trained physicians who identified polyps (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.|within 7 days|||||||
1421179|NCT01087502|Secondary|Plasma Concentration of Linagliptin at Trough|Trough levels of concentration of Linagliptin in plasma.|Week 12, 24 and 52|FAS original results (OR). Original results analysis means that data is analyzed exactly as observed, values after rescue medication are not set to missing and no imputation rule is applied for replacing the missing values.|||Nmol/L||Geometric Coefficient of Variation|Geometric Mean
1421181|NCT01087502|Secondary|Percentage of Patients With HbA1c <6.5%|The percentage of patients with an HbA1c value below 6.5% at week 12 and week 52 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively they were considered a failure, so HbA1c above 6.5%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=6.5% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.|||percentage of patients|||Number
1421182|NCT01087502|Secondary|Percentage of Patients With HbA1c <7.0%|The percentage of patients with an HbA1c value below 7% at week 12 and week 52 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 12 or 52 respectively, they were considered a failure, so HbA1c above 7%.|Baseline, week 12 and week 52|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF). Results after Week 12 include patients from the excluded study site.|||percentage of patients|||Number
1421183|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline Over Time|This change from baseline reflects the FPG over time minus the baseline FPG. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.|||mg/dL||Standard Deviation|Mean
1421184|NCT01087502|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|One patient in the Placebo/Glimepiride arm and one patient in the Linagliptin arm without FPG on-treatment value. Results do not contain data of patients from the excluded study site.|||mg/dL||Standard Error|Mean
1421185|NCT01087502|Secondary|HbA1c Change From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent over time minus the baseline HbA1c percent. This outcome measure only provides descriptive statistics without any modelling.|Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52|FAS. Last observation carried forward (LOCF) was used as the imputation rule. Results do not contain data of patients from the excluded study site.|||Percent||Standard Deviation|Mean
1421186|NCT01087502|Primary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.|Baseline and week 12|"FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.~Results for primary endpoint below are the ones reproduced without patients from the excluded study site."|||Percent||Standard Error|Mean
1421187|NCT01087489|Secondary|Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage|"Presence of corneal staining after the injection:~Quadrants of fluorescein staining: 0 1 2 3 4~Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion~Size of subconjunctival hemorrhage:~in clock hours"|within 10 minutes of the injection|all eyes for which data were available were included|||units on a scale|Participants|Standard Deviation|Mean
1421188|NCT01087489|Secondary|Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg|intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection.|immediately after injection, at 5, 10, 15 minutes|48 participants were included in each arm, i.e. each participant received both methods, one eye twice if unilateral or both eyes if bilateral disease were randomily assigned to alternate prep on consecutive or same visit respectively|||mmHg|Participants|Standard Deviation|Mean
1421189|NCT01087489|Primary|Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection|"Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe~Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied"|immediately after injection, 1- hour later, and next day|all 50 patients who completed the study were included in the analysis, each patient received both anesthetic preparations prior to two consecutive (if unilateral disease) intravitreal injections on consecutive visits or in fellow eyes (if bilaterla disease) on the same day|||units on a scale||Standard Deviation|Mean
1421190|NCT01086969|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination|Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia|Day 0 to 7 post-vaccination|Safety parameters were assessed in the safety analysis set|||Participants|||Number
1421191|NCT01086969|Primary|Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 to 30 post-vaccination|Four-fold antibody increase were determined in the immunogenicity analysis set|||Percentage of Participants|||Number
1421192|NCT01086969|Primary|Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination|Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.|Day 0 and Day 30 post-vaccination|Geometric mean titers were determined in the immunogenicity analysis set|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
1421193|NCT01086969|Primary|Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination|Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.|Baseline and 21 days post-vaccination|Menactra vaccine antibody titers were determined in the immunogenicity analysis set.|||Participants|||Number
1421245|NCT01086410|Secondary|Cmax for FF on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1421194|NCT01086852|Primary|Number of Participants With Degree of Bleeding Control Rated as Excellent.|"Investigators made an overall assessment of FACTOR X in controlling bleeding at the End of Treatment Assessment. The degree of bleeding control was rated as excellent, good, poor or unassessable, in accordance with the following criteria listed below:~Excellent -Parameters were similar to those in subjects without a bleeding disorder.~Good -Parameters were inferior to those in subjects without a bleeding disorder, but no other factor X containing agents were required to restore haemostasis.~Poor - Blood loss was excessive (defined as more than twice the pre defined amount that would be expected in a subject without a bleeding disorder for this type of surgery) and/or Haemostasis was not achieved and/or Additional factor X containing agents were required to restore haemostasis.~Unassessable -Efficacy was not possible to assess, or Additional factor X containing agents (excluding blood transfusions) were required before efficacy of FACTOR X could be assessed."|During and till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||Participants|||Number
1421195|NCT01086852|Secondary|Dose Per Infusion (IU/kg)|weight adjusted dose per infusion until a subject was no longer at risk of bleeding due to surgery|before surgery, during the post operative period|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||IU/kg||Full Range|Median
1421196|NCT01086852|Primary|Change of Haemoglobin From Pre-surgery Till End of Treatment|The subject’s haemoglobin was measured pre operatively, within 2 hours post operatively and at the End of Treatment Assessment. Changes in the subject’s haemoglobin from pre to post operatively and from post operatively to the End of Treatment Assessment were assessed, taking into account the volume of fluid infused into the subject during the intervening periods, any blood transfusions in the intervening periods, the subject’s haematocrit at the same time points and the subject’s pre dose serum ferritin|2 hrs pre-operatively till end of treatment|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||g/L||Standard Deviation|Geometric Mean
1421197|NCT01086852|Primary|Number of Post Operative Bleeding Episodes (See Table Below)|Bleeding was assessed at least once each day by the investigator, more frequently if indicated by the severity of the operation or the subject’s response. This included all bleeding episodes from the end of the surgical procedure until the subject was no longer at risk of bleeding due to surgery|End of surgery till end of study|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||number of bleeds|||Number
1421198|NCT01086852|Primary|Requirement for Blood Transfusion|Number of blood transfusions required (units of packed red blood cells or units of whole blood) or infusion of autologous red cells during and after surgery|during and after surgery|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||number of transfusions|||Number
1421199|NCT01086852|Primary|Clinical Assessment of Blood Loss During Surgery Against the Volume of Blood Loss Expected in Patients Without a Bleeding Disorder.|The investigator's estimation of the volume of blood loss during surgery compared to the volume of blood loss expected in patients without a bleeding disorder undergoing the same surgical procedure and reported as greater than, equal to or less than.|After wound closure|All subjects treated with FACTOR X|||participants|||Number
1421200|NCT01086852|Secondary|Incremental Recovery After Bolus Dose of FACTOR X|"Incremental Recovery of FX:C after the Pre surgery Bolus Infusion The factor X increment is calculated by subtracting the pre-infusion factor X level from the post-dose value.~Incremental recovery is calculated by FX increment (IU/dL)/ FX dose (IU/kg)"|incremental recovery was assessed at approximately 30 minutes after the pre surgery bolus|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||IU/dL per IU/kg||Standard Deviation|Geometric Mean
1421201|NCT01086852|Primary|Clinical Estimation of Volume of Blood Loss During Surgery|"As soon as possible after wound closure, the investigator estimated the volume of blood loss during surgery and made a clinical assessment against the volume of blood loss typically expected in a normal patient (i.e. one without a bleeding disorder and undergoing the same surgical procedure). The assessment may have been supported by a swab and pad count.~The clinical assessment was rated as follows:~Blood loss less than expected~Blood loss as expected~Blood loss more than expected~Blood loss excessive (defined as more than twice the pre defined amount that would be expected in a normal patient for this type of surgery)"|Blood loss is measured during and after surgery, the overall assessment is made after the last dose of FACTOR X.|The ITT population will be defined as all surgical procedures in which subjects were treated with at least one dose of FACTOR X and have undergone surgery.|||ml||Standard Deviation|Geometric Mean
1421202|NCT01086761|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|Safety Population included all treated participants.|||Participants|||Number
1421203|NCT01086761|Secondary|Maximum Serum Concentration (Cmax) of MP0112 at Day 3|Blood samples were collected for MP0112 levels on Day 3. The serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory and were analyzed for MP0112 levels using an enzyme-linked immunosorbent assay. Maximum concentration at Day 3 was calculated.|Day 3|Pharmacokinetic (PK) Population included all treated participants with PK data.|||Nanomolar (nM)|||Number
1421204|NCT01086761|Secondary|Area of Lesion as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye after fluorescein application at Baseline and Week 4. A lower number indicated a smaller lesion area.|Baseline, Week 4|All treated participants with data available for analysis.|||mm^2||Standard Deviation|Mean
1421270|NCT01086228|Secondary|Number of Participants With All Deaths and All MI||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421205|NCT01086761|Secondary|Area of Leakage as Measured by Fluorescein Angiography|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the dilated study eye 10 minutes after fluorescein application at Baseline and Week 4. A lower number indicated a smaller area of leakage.|Baseline, Week 4|All treated participants.|||mm^2||Standard Deviation|Mean
1421206|NCT01086761|Secondary|Change From Baseline in Central Area Retinal Thickness|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Week 4. A negative change from Baseline indicated improvement (less retinal thickness). A positive change from Baseline indicated worsening (definite retinal thickening).|Baseline, Week 4|All treated participants.|||μm||Standard Deviation|Mean
1421207|NCT01086761|Secondary|Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 4. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision. Stable or Improved BCVA was defined as a loss of <15 letters read correctly compared to Baseline.|Baseline, Week 4|All treated participants.|||Percentage of participants|||Number
1421208|NCT01086761|Primary|Maximal Tolerated Dose (MTD) Following a Single Injection|MTD was defined as one dose level below the lower of the dose level in which a severe (sight-threatening) drug-related Adverse Event occurred or the dose level at which more than 2 patients experienced a moderate ocular (eye) drug-related toxicity.|16 weeks|All treated participants.|||mg|||Number
1421209|NCT01086605|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of participants reporting a grade 3 or higher toxicity is reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 1 year after treatment||||Participants|||Count of Participants
1421210|NCT01086605|Secondary|Duration of Response|Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented at each dose level. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier at each dose level.|Up to 5 years||||months||Full Range|Mean
1421211|NCT01086605|Secondary|Overall Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier at each dose level.|Up to 5 years||||months||95% Confidence Interval|Median
1421212|NCT01086605|Secondary|6-month Progression-free Survival Rate|The 6-month progression free survival (6-mo PFS) rate is the proportion of efficacy-evaluable patients progression-free 6 months from registration. The 6-mo PFS rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study. Patients who died without documentation of progression will be considered to have progressed on the date of their death. The true 6-mo PFS rate will be estimated by the proportion of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration at each dose level. Binomial confidence intervals for 6-mo PFS rate will be constructed for each dose level. Progression is defined using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1).|At 6 months||||proportion||95% Confidence Interval|Number
1421213|NCT01086605|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression one day post-registration. The distribution of time to progression will be estimated using the method of Kaplan-Meier at each dose level. Progression is defined using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1).|Up to 5 years||||months||95% Confidence Interval|Median
1421214|NCT01086605|Primary|Proportion of Confirmed Tumor Responses (Complete or Partial Response)|The proportion of confirmed responses will be estimated by the number of women who achieve a CR or PR on two consecutive evaluations at least 6-8 weeks apart depending on the dose level. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients at each dose level. Confidence intervals for the true success proportion at each dose level will be calculated according to the approach of Duffy and Santner. Response will be evaluated in this study using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1); Complete Response (CR): Disappearance of all non-nodal target lesions, each target lymph node must have reduction in short axis to <1.0 cm. and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axis of the target lymph nodes taking as reference the Baseline Sum of Diameters.|Up to 5 years||||proportion||95% Confidence Interval|Number
1421271|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1446636|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).||Baseline up to Month 7||||percentage of participants|||Number
1421215|NCT01086475|Primary|Social Responsiveness Scale (SRS) at Follow-Up|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:~0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Week 22|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.|||units on a scale||Standard Deviation|Mean
1421216|NCT01086475|Secondary|Clinical Global Impressions Improvement Scale Responder Analysis|The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point. The CGI-I was completed at each visit, but only at week 11 were those subjects classified as “much” or “very much improved” defined as responders and all other classifications will be regarded as non-responders.|Week 11|Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.|||percentage of participants|||Number
1421217|NCT01086475|Primary|Social Responsiveness Scale (SRS) Change|"The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:~0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment"|Completed at Baseline and Week 11|Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.|||units on a scale||Standard Deviation|Mean
1421218|NCT01086423|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 4/5)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1421219|NCT01086423|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period after any dose|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1421220|NCT01086423|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1421221|NCT01086423|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1421222|NCT01086423|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1421223|NCT01086423|Secondary|Anti-polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
1421224|NCT01086423|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1421225|NCT01086423|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.|Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1421272|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1432399|NCT00993031|Primary|Prevalence of Malaria Defined as Positive Placental Blood Smear|Number of participants with positive placental blood smear for malaria|Delivery|Placental blood smear|||participants|||Number
1421226|NCT01086423|Primary|Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens|"Vaccine response was defined as:~For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.~For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination."|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1421227|NCT01086423|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens|A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1421228|NCT01086423|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1421229|NCT01086423|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|One month after the third vaccine dose (Month 3 or Month 4)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1421230|NCT01086410|Secondary|Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline|Heart rate was measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Beats per minute||Standard Deviation|Mean
1421231|NCT01086410|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline|SBP and DBP were measured at Baseline and at Days 14, 28, 42, and EW. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value. Scheduled, unscheduled, and early withdrawal visits were used for the maximum post-Baseline assessment.|Days 14, 28, 42, and EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1421232|NCT01086410|Secondary|Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1421233|NCT01086410|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1421234|NCT01086410|Secondary|Change From Baseline in Albumin and Total Protein Values at Day 42/EW|Blood samples were collected for the measurement of albumin and total protein at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter||Standard Deviation|Mean
1421273|NCT01086228|Secondary|Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421274|NCT01086228|Secondary|Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421235|NCT01086410|Secondary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW|Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1421236|NCT01086410|Secondary|Change From Baseline in Hematocrit Values at Day 42/EW|Blood samples were collected for the measurement of hematocrit at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1||Standard Deviation|Mean
1421237|NCT01086410|Secondary|Change From Baseline in Hemoglobin Values at Day 42/EW|Blood samples were collected for the measurement of hemoglobin at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1421238|NCT01086410|Secondary|Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW|Blood samples were collected for the measurement of eosinophils, total neutrophils, platelets, and WBC count at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/EW|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1421239|NCT01086410|Secondary|Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Day 42/EW. For all laboratory assessments, Baseline is the most recent recorded value at Screening or prior to Day -1/1. Change from Baseline was calculated as the Day 42/EW value minus the Baseline value.|Baseline and Day 42/Early Withdrawal (EW)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage||Standard Deviation|Mean
1421240|NCT01086410|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Day 42 (Visit 5)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study drug.|||Participants|||Number
1421241|NCT01086410|Secondary|Tmax and Tlast of VI at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
1421242|NCT01086410|Secondary|Cmax for VI on Day 42|Cmax is defined as the maximum observed concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1421243|NCT01086410|Secondary|AUC(0-t) for VI on Day 42|Area under the concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable VI concentration on Day 42 was measured. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||picograms*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
1421244|NCT01086410|Secondary|Tmax and Tlast of FF at Day 42|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 42. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed.|||hours||Full Range|Median
1446879|NCT00877929|Secondary|Systolic Blood Pressure (SBP) Control 140 at Eight Weeks|Mean seated SBP < 140 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
1421246|NCT01086410|Secondary|AUC(0-t) and AUC(0-24) for FF on Day 42|Area under the plasma drug concentration-time (AUC[0-t]) curve from time zero (pre-dose) to the last time of quantifiable FF concentration and AUC(0-24) is the concentration time curve from zero (pre-dose) to 24 hours of quantifiable FF concentration on Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr post-dose on Day 42.|Day 42|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
1421247|NCT01086410|Secondary|Plasma FF and VI Pharmacokinetic (PK) Concentration|Plasma FF and VI Pharmacokinetic (PK) Concentration were estimates at the following time points:0 (immediately pre-dose inhaled study drug), and post-dose at 5 min, 15 min, 30 min, and 1 hr, 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, 24 hr on Day 42. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 42|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1421248|NCT01086410|Secondary|Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42|A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at Day -1/1 (Baseline) and Day 42. Only those participants available at the specified time points were analyzed. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|Urine Cortisol (UC) Population: all participants in the ITT Population who did not have protocol deviations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that would affect the interpretation of the results.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
1421249|NCT01086410|Secondary|Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42|Serum cortisol trough is defined as the minimum value of serum cortisol measured over the 24-hour period. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
1421250|NCT01086410|Secondary|Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42|Area under the plasma drug concentration-time (AUC[0-24 hour]) curve from time zero (pre-dose) to the last time of quantifiable serum cortisol concentration at 24 hours post-dose on Day -1/1 (Baseline) and Day 42 was measured. AUC reflects the actual body exposure to drug over a specified period of time after administration of a dose. Samples were collected at the following times: 0 (immediately pre-dose inhaled study drug); post-dose at 5 minutes (min), 15 min, 30 min, and 1 hour (hr), 2 hr, 4 hr, 9 hr, 12 hr, 16 hr, 20 hr, and 24 hr. Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.|Day -1/1 (Baseline) and Day 42|SC Population. Only those participants available at the specified time points were analyzed.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
1421251|NCT01086410|Primary|Ratio From Baseline of the Serum Cortisol Weighted Mean (0–24 Hours) on Day -1/1 (Baseline) and Day 42|"Serum cortisol weighted mean was determined for each participant over the time period 0–12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the 0 time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline."|Day -1/1 (Baseline) and Day 42|Serum Cortisol (SC) Population: all participants in the Intent-to-Treat Population who did not have protocol deviations that were considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors affecting results interpretation. Only those participant available at the specified time points were analzyed.|||ratio from Baseline||Geometric Coefficient of Variation|Geometric Mean
1421252|NCT01086384|Secondary|Change From Baseline in Evening Pre-dose Trough FEV1 at Week 36|Evening pre-dose trough (lowest value) forced expiratory volume in one second (FEV1) was measured using spirometry equipment that met or exceeded the minimal performance recommendations of the American Thoracic Society. FEV1 is a measure of the maximum amount of air forcefully exhaled in one second. Change from Baseline in evening pre-dose FEV1 was analyzed using an Analysis of Covariance (ANCOVA) model with effects due to Baseline FEV1, sex, age, region, and treatment. Change from Baseline was calculated as the Week 36 value minus the Baseline value.|Baseline and Week 36|ITT Population. Only those participants available at the indicated time point (Week 36) were analyzed.|||Liters||Standard Deviation|Least Squares Mean
1421253|NCT01086384|Secondary|Number of Severe Asthma Exacerbations|A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. A participant may have had one or more exacerbations.|Baseline to Follow-up (up to 76 weeks of treatment)|ITT Population|||Severe asthma exacerbations|||Number
1421275|NCT01086228|Secondary|Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421254|NCT01086384|Primary|Number of Participants With 1 or More Severe Asthma Exacerbations|Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma exacerbations. The time to the first severe asthma exacerbation was analyzed using a Cox proportional hazards regression model, adjusting for Baseline disease severity (Baseline forced expiratory volume in one second [FEV1, maximum amount of air forcefully exhaled in one second]), sex, age, and region.|Baseline to Follow-up (up to 76 weeks of treatment)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication.|||participants|||Number
1421255|NCT01086358|Secondary|Favorable Response on Migraine-ACT|The Migraine-ACT is a 4-item scale with yes/no responses. A score of 3 or more is considered favorable. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The Migraine-ACT is reported as a binary measure (3 or more positive responses). The outcome presented included the percentage with a score of 3 or more, and the Odds ratio comparing the two treatments.|6 months||||percentage of favorable responses||95% Confidence Interval|Mean
1421256|NCT01086358|Secondary|Lost Activity Time|This outcome measure was lost activity time as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.|6 Months|This includes all patients that completed all study visits are included in this efficacy analysis|||hours||95% Confidence Interval|Mean
1421257|NCT01086358|Secondary|Lost Workplace Productivity|This outcome measure was lost workplace productivity as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.|6 months|This includes all patients that completed all study visits are included in this efficacy analysis|||hours||95% Confidence Interval|Mean
1421258|NCT01086358|Primary|Workplace Productivity and Activity Impairment Scale (WPAI).|The primary outcome measure was lost productivity (workplace productivity + non-workplace activity time) as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.|6 months|This includes all patients that completed all study visits are included in this efficacy analysis|||hours||95% Confidence Interval|Mean
1421259|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and CI-TLR||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421260|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and CI-TLR||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421261|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and CI-TLR||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421262|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and TLR||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421263|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and TLR||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421264|NCT01086228|Secondary|Number of Participants With All Deaths, TVMI and TLR||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421265|NCT01086228|Secondary|Number of Participants With All Deaths, All MI and All Revascularization||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421266|NCT01086228|Secondary|Number of Participants With All Deaths, All MI and All Revascularization||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421267|NCT01086228|Secondary|Number of Participants With All Deaths, All MI and All Revascularization||Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421268|NCT01086228|Secondary|Number of Participants With All Deaths and All MI||From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421269|NCT01086228|Secondary|Number of Participants With All Deaths and All MI||From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421280|NCT01086228|Secondary|Number of Participants With Cardiac Death and All MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421281|NCT01086228|Secondary|Number of Participants With Cardiac Death and All MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421282|NCT01086228|Secondary|Number of Participants With Cardiac Death and All MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421283|NCT01086228|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|From 2 Years to 3 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421284|NCT01086228|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421285|NCT01086228|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421286|NCT01086228|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421287|NCT01086228|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|From 1 year to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421288|NCT01086228|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1422155|NCT01078675|Primary|Percent Change From Baseline in Height|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Safety Population|||Percent change||Standard Deviation|Mean
1421289|NCT01086228|Secondary|Number of Participants With Myocardial Infarctions (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421290|NCT01086228|Secondary|Number of Participants With Myocardial Infarctions (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|From 1 year to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421291|NCT01086228|Secondary|Number of Participants With Myocardial Infarctions (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421292|NCT01086228|Secondary|Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421293|NCT01086228|Secondary|Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|From 1 to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421294|NCT01086228|Secondary|Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|Post Procedure to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421295|NCT01086228|Secondary|Acute Success|"Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met:~Stent was successfully delivered to the intended location~Stent was successfully deployed at the intended location~Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure."|On day 0 (Immediately post-index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of stents|stents||Number
1421296|NCT01086228|Secondary|Net Gain|Net Gain = Acute Gain - Late Loss, paired analysis only.|On day 0 after procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||millimeters|lesions|95% Confidence Interval|Mean
1421297|NCT01086228|Secondary|Late Loss|Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] – [MLD at 8 months].|On day 0 after procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||millimeters|lesions|95% Confidence Interval|Mean
1421298|NCT01086228|Secondary|Acute Gain|The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).|On day 0 after procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||millimeters|lesions|95% Confidence Interval|Mean
1421299|NCT01086228|Secondary|Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|At 8 months|Eight-month follow-up angiograms for 1,309 lesions in 1,085 patients were assessed by the core laboratory.|||Percent Diameter stenosis|lesions|Standard Deviation|Mean
1421300|NCT01086228|Secondary|Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|On day 0 after procedure|Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.|||Percent Diameter stenosis|lesions|Standard Deviation|Mean
1421301|NCT01086228|Secondary|Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Baseline|Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.|||Percent Diameter stenosis|lesions|Standard Deviation|Mean
1421302|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 4 years to 5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421303|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 3 years to 4 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421304|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421305|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From 1 year to 2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421306|NCT01086228|Secondary|Number of Participants With Adverse Events Related to Anti-platelet Medication||From post-procedure to 1 year||||participants|||Number
1421307|NCT01086228|Primary|Number of Participants With Stent Thrombosis (ST) as Per ARC Definition|"Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~Probable ST may occur due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.~Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up"|From 2 years to 3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421308|NCT01086228|Primary|Number of Participants With Stent Thrombosis (ST) as Per ARC Definition|"Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~Probable ST may occur due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.~Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up"|From 1 Year to 2 Years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
1421309|NCT01086228|Primary|Number of Participants With Stent Thrombosis (ST) as Per ARC Definition|"Definite ST occurred by either angiographic/pathologic confirmation of ST.~Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours:~Acute onset of ischemic symptoms at rest~New ischemic ECG changes~Typical rise&fall in cardiac biomarkers~Non-occlusive &occlusive thrombus~Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy.~Probable ST may occur due to:~Unexplained death within first 30 days~Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause.~Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up"|Post Procedure to 1 Year||||participants|||Number
1421310|NCT01086215|Secondary|Concomitant Treatments Used With the AngioJet® System|The # of patients exposed to each treatment option at least once in the given thrombotic condition during the Index Procedure|Day 1||||participants|||Number
1421311|NCT01086215|Primary|Rethrombosis|The number of patients affected by rethrombosis of the treated vessels (first episode) throughout a 12 Month Follow-Up.|3 Month , 6 Month and 12 Month Follow Up||||participants|||Number
1421312|NCT01086215|Primary|Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms/venograms, each vessel was assigned a value by the treating physician.~complete occlusion (>90% occlusion);~substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);~partial occlusion (<50% occlusion AND <3cm in length)~patent (without visable thrombus or occlusion) The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic/venographic value from the final value."|Day 1|Intention to Treat (ITT)|||Units on a Scale||Standard Error|Mean
1421313|NCT01086033|Secondary|Percentage of Participants Who Missed at Least One Dose of Humira|Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.|Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1421398|NCT01085136|Secondary|Progression Free Survival (Part A)|"Progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for Part A.~Median was calculated from the Kaplan−Meier curve."|From first dose administration until disease progression or death; Up to 51 months|Treated set|||Months||95% Confidence Interval|Median
1448003|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT|||parts per billion (ppb)||Standard Deviation|Mean
1421314|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 70 Response|"American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR70 could be calculated at each time point."|||participants|||Number
1421315|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 50 Response|"American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR50 could be calculated at each time point."|||participants|||Number
1421316|NCT01086033|Primary|Number of Participants With an American College of Rheumatology (ACR) 20 Response|"American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~Acute phase reactant value (C-reactive protein [CRP])."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; the analysis was performed on the basis of non-missing information and no imputation methods were used. n indicates the number of patients for whom ACR20 could be calculated at each time point."|||participants|||Number
1421317|NCT01086033|Primary|European League Against Rheumatism (EULAR) Response|"A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.~A Moderate EULAR Response is defined as either:~an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or~an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.~No Response is defined as either:~an improvement (decrease) in the DAS28 of ≤ to 0.6, or~an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1."|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|Safety population;|||participants|||Number
1421318|NCT01086033|Primary|Disease Activity Score (DAS) 28 Over Time|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36|"Safety population; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
1421319|NCT01086033|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant."|3 years|The safety population, including all patients that received at least one dose of the study drug.|||participants|||Number
1421320|NCT01085968|Secondary|Symbol Digit Modality Test (SDMT)|"Symbol Digit Modality Test (SDMT): Participants are given a key of numbers (1-9) corresponding to symbols for reference.~Task: Participants are given a page of symbols and are instructed to say aloud the number corresponding to each symbol on the page.~This task is timed for completion and the score is reported as the number of symbol to number matching correct in 90 seconds."|time of enrollment and 2 months following enrollment (before and after training)||||Number of Correct Matches in 90 seconds||Standard Deviation|Mean
1421321|NCT01085968|Secondary|Functional Dexterity Test (FDT)|"Functional Dexterity test (FDT): a motor dexterity measurement for hands. Task: Pick up and flip wooden pegs on a 4x4 pegboard in a zig-zag pattern; timed. Task is performed 2 times per hand Modified Task: Interchange 2 columns of of pegs (4 pegs each side) simultaneously. No flipping is required.~5 second penalty to time score for 1.) using the pegboard to help with flipping and 2.) supinating of the hand; per occurrence. 10 second penalty to time score for dropping a peg, per occurrence."|time of enrollment and 2 months following enrollment (before and after training)||||Seconds||Standard Deviation|Mean
1421322|NCT01085968|Secondary|Task Errors and Variability|Left, right and bimanual errors in external cue and internally generated tasks for four-digit trials|time of enrollment and 2 months following enrollment (before and after training)||||Number of Errors||Standard Deviation|Mean
1421323|NCT01085968|Secondary|Neuropsychological Measures of Cognitive Function, Including Reaction Time and Time to Completion|"Modified Emory Functional Ambulatory Profile (mEFAP); mobility test Task 1: 5 meter walk on hard surface; timed. Task 2: 5 meter walk on carpeted surface, timed. Task 3: Timed up and go; rise from chair, walk 3 meters, walk back, sit down in chair, timed.~Task 4: Obstacle course, similar to the Timed up and go, with 2 obstacles to be stepped over while walking forward and coming back; timed.~Task 5: Ascend and descend 5 steps of stairs; timed."|time of enrollment and 2 months following enrollment (before and after training)||||Seconds||Standard Deviation|Mean
1421324|NCT01085968|Primary|Reaction Time and Variability for Movement Task|Before and after computer training outcome measures: left, right, bimanual external cue reaction time; left, right, bimanual external cue error; left, right, bimanual internally generated reaction time; left, right, bimanual internally generated error for four-digit trials.|time of enrollment and 2 months following enrollment (before and after training)|PD Subjects: total number of subjects: 29, 8 withdrew from study, 2 had incomplete data. CO Subjects: total number of subjects: 25, 4 withdrew from study|||milliseconds||Standard Deviation|Mean
1421325|NCT01085903|Secondary|Time to Swallow Puree Food|This is a behavioral measure of swallowing - the time it takes for pureed food to transition across a part of the throat. The difference score is calculated as CPS - placebo and as modafinil - placebo (for stroke subjects only).|baseline and after three days of intervention||||seconds||Standard Deviation|Mean
1421326|NCT01085903|Secondary|Power Function Exponent for Oral Bolus Estimation|This is a behavioral measure of sensation in the oral cavity. The power function exponent is equal to the slope of a regression equation relating bolus size to a person's estimate of that size. An exponent below one implies an underestimate of bolus size. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention||||exponent||Standard Deviation|Mean
1421327|NCT01085903|Secondary|PVT Fastest 10 Percent of Reaction Times|This is a behavioral measure of arousal - the fastest 10 percent of all cued reaction time trials. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention||||milliseconds||Standard Deviation|Mean
1421328|NCT01085903|Primary|P50 Percent Habituation Score|This is an electrophysiological measure of arousal - a percent change in the P50 evoked response potential amplitudes with a 250 ms inter stimulus interval. The difference score is calculated as CPS - baseline and as modafinil - placebo (stroke subjects only).|baseline and after three days of intervention||||percentage of change in amplitude||Standard Deviation|Mean
1421329|NCT01085825|Primary|Accurate Confirmation of Completed Abortion|Accurate confirmation of completed abortion, as determined by urine pregnancy test at following, appropriately falling serum hCG levels, or patient report of returned menses|2 weeks - 6 months||||participants|||Number
1421330|NCT01085786|Secondary|Compliance Rate|Good compliance is defined as taking equal or more than 90% of eradication medicines|Dec 2010|||||||
1421331|NCT01085786|Secondary|Adverse Events|by standardized questionnaire|Dec 2010|||||||
1421332|NCT01085786|Primary|Number of Participants in Which H. Pylori Was Eradicated|evaluate eradication outcome by endoscopy with urease test or urea breath test|Dec 2010||||participants||95% Confidence Interval|Number
1421333|NCT01085760|Secondary|Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment||baseline, 12 weeks|Per protocol analysis done|||mg/L||Full Range|Median
1421334|NCT01085760|Secondary|Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment|The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age [years]) + 0.54 Ln (total bilirubin [mg/dL]) + 0.54 Ln (AST [IU/L]) + 1.24 (variceal bleeding) – 0.84 (albumin [g/dL]). There is no range, minimum, or maximum value but greater values indicate worse disease.|baseline, 12 weeks|Per protocol analysis|||units on a scale||Full Range|Median
1421335|NCT01085760|Secondary|Change From Baseline in Total Bilirubin Following 12 Weeks Treatment||baseline, 12 weeks|Per protocol analysis done|||mg/dl||Full Range|Median
1421336|NCT01085760|Primary|Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment||baseline, 12 weeks|The number of participants was based on a per protocol analysis.|||U/L||Full Range|Median
1421337|NCT01085734|Secondary|Change in Macular Thickness and Macular Volume|OCT central subfield thickness measured in microns|6 months||||microns||Standard Deviation|Mean
1421338|NCT01085734|Secondary|Number of Injections Needed|number of Avastin and Ozurdex injections needed|baseline to 6 months||||injections|||Number
1421339|NCT01085734|Primary|Change From Baseline Visual Acuity at 6 Months|Visual Acuity was measured with ETDRS visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|6 months||||ETDRS score||Standard Deviation|Mean
1421340|NCT01085682|Primary|Incidence of Type 2 Diabetes Mellitus|Incidence of type 2 diabetes mellitus|one year follow up||||participants|||Number
1421341|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
1421394|NCT01085136|Secondary|Intensity and Incidence of Adverse Events (AEs) for Part A & Part B.|Safety of Afatinib as indicated by intensity and incidence of adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0 both for Part A and Part B. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 51 Months (Part A) and from randomization until 28 days after last drug administration of Trial medication, up to 32 Months (Part B)|Treated Set|||Percentage of participants|||Number
1421342|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Lubiprostone)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
1421343|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Lubiprostone|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
1421344|NCT01085643|Secondary|A Change in Length of Spread of Retrograde Contractions After Placebo|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
1421345|NCT01085643|Primary|A Change in Length of Spread of Antegrade Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
1421346|NCT01085643|Secondary|A Change in Length of Spread of Long Distance Propagating Contractions After Placebo.|Pressure waves are considered to represent contractions if the rise in intraluminal pressure is >10mmHg above the baseline. They are considered propagating if they are recorded in more than one channel and occur within a time frame that allowed a minimal velocity of 0.7cm/sec and maximum velocity of 4cm/sec. All contractions, their direction (antegrade, stationary or retrograde) and the length of spread will be determined for each sequence at baseline (after taking Placebo)and within the following 3 hours.|baseline and within the following 3 hours|Considering the fact that this is a pilot study, per protocol a total of 20 subjects should have been recruited; however, due to the limited time and complexity of the study, only 4 subjects completed the study. Due to that fact an analysis of the outcome measures was not submitted, since the results will not provide a meaningful data.|||cm||Standard Deviation|Mean
1421347|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Failure or Unable to Evaluate at the End of Study Treatment|The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant’s condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
1421348|NCT01085591|Secondary|Median Time to Resolution of Diarrhea|The median time to resolution of diarrhea is presented for evaluable participants in each treatment group. The time in days from the start of treatment (time of first dose of study drug) to resolution (time of the last UBM on the day before the first of 2 consecutive days of < 4 UBMs and sustained through the second day following the last dose of study drug).|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug, had a confirmed diagnosis of Clostridium difficile infection (CDI), and who achieved resolution of their diarrhea.|||Days||95% Confidence Interval|Median
1421349|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. If diarrheal symptoms returned, participants were asked to indicate the number of UBM they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week FUP. Strain at Baseline=SAB.|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
1421350|NCT01085591|Secondary|Number of Participants With a Clinical Response Outcome at the End of Study Treatment With and Without Infection Caused by C. Difficile BI/NAP1/027 Strain at Baseline|The number of participants with investigator assessed clinical response of cure, failure or unable to evaluate is presented and shown separately for participants with and without infection caused by C. difficile BI/NAP1/027 strain as determined at baseline. Clinical response was determined by the participant’s condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the EOT. The information to assess clinical response for infection caused by C. difficile BI/NAP1/027 strain at Baseline was collected at any time up to and including Day 12. Strain at Baseline=SAB|Baseline (Day 0) through Study Day 12|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
1421351|NCT01085591|Secondary|Number of Participants With a Recurrence of Clostridium Difficile Infection Through the 4-week Follow-up Period|The number of participants with a recurrence of CDI is presented along with the number of participants without a recurrence and who were unable to be evaluated. Participants with a favorable outcome at the EOT (cure) were evaluated for recurrence of CDI. Only subjects deemed a cure at EOT were assessed for recurrence. This is the denominator used for all percentages. If diarrheal symptoms returned, participants were asked to indicate the number of unformed bowel movements (UBM) they had and have an additional C. difficile toxin test. The information to assess recurrence in participants who were deemed a cure at EOT was collected at any time during the 4-week Follow-up Period (FUP).|Study Day 10 up to Study Day 40|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||Participants|||Number
1421352|NCT01085591|Primary|Number of Participants With a Clinical Response Outcome of Clostridium Difficile Infection Cure at the End of Study Treatment|The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.|Baseline (Day 0) through Study Day 19|All participants who received any amount of study drug and had a confirmed diagnosis of Clostridium difficile infection (CDI).|||participants|||Number
1421353|NCT01085539|Primary|Detection of Oxygen Alarms That Resulted in Clinicians Changing the Care of the Infant.|Sat Secs is an oxygen alarm with 5 settings:0,10,25,50,and 100. At each setting,using the units of seconds,it filters nusiance alarms & identifies important alarms that result in the clinicians changing the care of the infant.|4 hours|All patients with complete data|||percentage of interventions|||Number
1421354|NCT01085513|Secondary|CE-EIA Scores for Dysmotility||within 7 days|||||||
1421355|NCT01085513|Secondary|Clinical Symptoms||within 7 days|||||||
1421356|NCT01085513|Secondary|Features Detected by CE-EIA: Contractile Patterns; Non Contractile Patterns - Wall and Tunnel Patterns; Luminal Content - Turbid Pattern; Endoluminal Motion; Capsule Displacement.||within 7 days|||||||
1421357|NCT01085513|Primary|Test Characteristics (i.e., Sensitivity, Specificity, NPV, PPV) of CE-EIA, as Compared to SB Manometry Which Will be Considered as an Imperfect Gold standard14.||within 7 days|The study was terminated without achieving the needed sample size due to very low recruitment rate. therefore, no statistical analysis has been performed. T||||||
1421358|NCT01085500|Secondary|Number of Hernia Repair Subjects With Post-Operative Urinary Retention|Urinary retention is the inability to empty the bladder. This is an educational study for surgeons. The participants in the study are surgeons, and the participant flow, baseline characteristics and first two outcome measures are for the surgeons. During the part of the study reported for the third outcome measure, the first surgical procedure (TEP) after randomization, each surgeon had one subject. Therefore, this outcome measure is for the hernia patients or subjects.|at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night||||Subjects|||Number
1421359|NCT01085500|Secondary|Operative Performance|The trained observer and the staff supervising surgeon graded operative performance independently using a global rating scale, Global Operative Assessment of Laparoscopic Skills (GOALS) immediately after each case, (1 rating per case if bilateral repair). The GOALS tool has been shown to be a valid and reliable tool to measure generic laparoscopic skills in the simulated environment and in the operating room, with good agreement between live and video-review ratings. The scores range from 6 to 30, a higher score indicates greater operative performance.|at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two||||units on a scale||Standard Deviation|Mean
1421360|NCT01085500|Primary|Participation-Corrected Operative Time|Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time_corrected = time_raw + (1-participation) x time_raw.|at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two||||minutes||Standard Deviation|Mean
1421361|NCT01085357|Secondary|Proportion of Eyes With Postoperative IOP ≥ 6 and ≤ 18 mmHg, as Measured by Goldmann Tonometry, at the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Month 24 postoperative|ITT|||percentage of eyes|Eyes||Number
1421395|NCT01085136|Secondary|Objective Response (Part B)|Objective response (CR, PR) of Afatinib/paclitaxel combination therapy and comparator chemotherapy in Part B after progression in Part A according to RECIST 1.1 .|Post baseline tumour-imaging was performed at every 8 weeks thereafter until disease progression; up to 32 Months|Randomized Set|||Percentage of participants||95% Confidence Interval|Number
1421362|NCT01085357|Secondary|Mean Change in IOP Between Baseline and Hypotensive Medication-free 24-month Postoperative Examination Using Baseline Value Imputation for Missing Data|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. A negative value indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Baseline IOP was used for subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|ITT|||mmHg||Standard Deviation|Mean
1421363|NCT01085357|Primary|Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A reduction in IOP from baseline indicates an improvement. One eye (study eye) contributed to the analysis. Proportion of eyes is reported as a percentage. Non-responders include subject eyes for which, prior to the relevant outcome time point: 1) Use of ocular hypotensive medication was not terminated; 2) IOP-affecting secondary surgical procedure was performed; 3) CyPass was explanted; or 4) CyPass was repositioned. IOP-affecting secondary surgical procedures include: Iridotomy, iridectomy, trabeculectomy, glaucoma shunt implantation, argon laser trabeculoplasty, selective laser trabeculoplasty, or other surgery that would affect IOP. Subject eyes for which CyPass implantation was attempted but not completed were treated as non-responders.|Baseline; Month 24 postoperative|Intent-to-treat (ITT)|||percentage of eyes|Eyes||Number
1421364|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAES between first dose of study drug administration and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, safety outcome measure could not be performed.||||||
1421365|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Best Overall Response|BOR was defined based on Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, Best overall response was not evaluated.||||||
1421366|NCT01085331|Secondary|Part 2 or Phase 2 Randomized Part: Circulating Biomarkers||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, circulating biomarkers were not evaluated.||||||
1421367|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Circulating Biomarkers in Serum||Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years|Number of subjects enrolled in the safety run-in part of the trial was less and it would not provide sufficient statistical power to perform any analysis. Hence, the biomarker samples were not analyzed as part of the trial.||||||
1421368|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Best Overall Response (BOR)|BOR was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 2 years|The efficacy analysis set included all subjects who received at least 1 trial drug dose (any of the three FOLFIRI drugs and pimasertib) and had a baseline tumor assessment and at least 1 post-baseline efficacy assessment.|||Subjects|||Number
1421369|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of AUC0-inf of Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)|The AUC(0-inf) was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Ratio||Full Range|Median
1421370|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Ratio of Cmax for Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Ratio of Cmax||Full Range|Median
1421486|NCT01084174|Primary|Number of Participants With Induced Peanut Desensitization at 12 Months|Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.|12 months||||Participants|||Count of Participants
1421371|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Volume of Distribution (Vz f) Pimasertib, (Vz) of Irinotecan and SN-38|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Liter||Full Range|Median
1421372|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Oral Clearance (CL/f) of Pimasertib, (CL) Irinotecan and SN-38|Clearance of a drug was a measure of the rate at which drug was metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||Liter per hour||Full Range|Median
1421373|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Apparent Terminal Half Life (t1/2) of Pimasertib, Irinotecan and SN-38|The t1/2 was defined as the time required for the plasma concentration of pimasertib and irinotecan to decrease 50% in the final stage of elimination.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||hour||Full Range|Median
1421374|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib, Irinotecan and SN-38|The AUC(0-inf) of pimasertib and irinotecan was estimated by determining the total area under the concentration time curve extrapolated to infinity.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The PK analysis population set included all subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). Here, N (total number of subjects analyzed) signifies number of evaluable subjects for this outcome measure. n signifies number of subjects evaluable per each category, respectively."|||ng/mL*hour||Full Range|Median
1421375|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to the Time of Last Observation (AUC0-t) of Pimasertib, Irinotecan and SN-38|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."|||(nanogram/milliliter)*hour([ng/mL]*hour)||Full Range|Median
1421376|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Time to Reach Maximum Observed Concentration (Tmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."|||hour||Full Range|Median
1421377|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Maximum Observed Plasma Concentration (Cmax) of Pimasertib, Irinotecan and SN-38||Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38|"The pharmacokinetic (PK) evaluation set included subjects who had an evaluable plasma concentration-time profile on any of the PK sampling days (Day 1 or 8 or 15). n signifies number of subjects evaluable in each category, respectively."|||nanogram per milliliter (ng/mL)||Full Range|Median
1421378|NCT01085331|Secondary|Part 1 or Safety Run-in Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 28 days after the last dose of study drug administration|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).|||Subjects|||Number
1421379|NCT01085331|Primary|Part 2 or Phase 2 Randomised Part: Progression Free Survival (PFS)|PFS was defined as time (in months) from the date of randomization to the first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0) or death for any cause.|From randomization up to first documented disease progression maximum up to 2 years|Part 2 or Phase 2 Randomized Part of the trial was not conducted. Hence, PFS was not evaluated for this study.||||||
1421396|NCT01085136|Secondary|Objective Response (Part A)|Objective response defined as the best overall response of complete response [CR]: disappearance of all target lesion & partial response [PR]: ≥30% decrease in the sum of the longest diameter of target lesions , taking as reference the baseline sum longest diameter of Afatinib monotherapy according to RECIST 1.1 for Part A.|Post baseline tumour-imaging was performed at every 6 weeks thereafter until disease progression; upto 51 months|Treated set|||Percentage of participants||95% Confidence Interval|Number
1421397|NCT01085136|Secondary|Overall Survival (Part B)|"Overall survival (OS) as determined by the time from randomization to death in part B.~Median was calculated from the Kaplan−Meier curve."|From randomization until death; Up to 32 months|Randomised Set|||Months||95% Confidence Interval|Median
1421501|NCT01084005|Secondary|FPG Change From Baseline to Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin.|Baseline and week 24|FAS (LOCF)|||mg/dL||Standard Error|Mean
1421380|NCT01085331|Primary|Part 1 or Safety Run-in Part: Maximum Tolerated Dose (MTD)|MTD was defined as the dose level, at which the treatment-related dose limiting toxicity (DLT) occurred in >1 of 3 subjects or in >1 of 6 subjects. DLT was defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Any Grade >=3 non-hematological toxicity except for Grade 4 asymptomatic increases in liver function tests (LFTs) reversible within 7 days in subjects with liver involvement, Grade 3 asymptomatic increases in LFTs reversible within 7 days in subjects without liver involvement, Grade 3 vomiting controlled with adequate and optimal therapy and prophylaxis, and Grade 3 diarrhea controlled with adequate and optimal anti-diarrhea therapy; any Grade 4 neutropenia lasing >5 days/ febrile neutropenia lasting >1 day; any Grade 4 thrombocytopenia/Grade 3 with bleeding; any treatment delay >2 weeks due to trial treatment-related adverse effects at any dose level and judged to be possibly or probably related to the trial treatment.|Baseline up to Day 28 (Part 1)|The safety analysis set included all subjects who received at least one (non-zero) administration of the trial medication (any of the 3 FOLFIRI drugs and pimasertib).|||mg|||Number
1421381|NCT01085318|Other Pre-specified|Time to First Clinical Relapse|Time to First Clinical Relapse|Months||||months||Standard Deviation|Mean
1421382|NCT01085318|Other Pre-specified|Clinical Relapses|Clinical Relapses|Over 6 months||||relapses per participant||Standard Deviation|Mean
1421383|NCT01085318|Secondary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months|To characterize the effect of Rebif on demyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6||||mm^3||Full Range|Median
1421384|NCT01085318|Primary|Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months|To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).|Baseline to Month 6|The analysis were run on the Intent-to-Treat (ITT) set defined as all RRMS subjects with at least one injection of Rebif and all HC who signed the informed consent form. Missing data were not imputed.|||mm^3||Full Range|Median
1421385|NCT01085214|Other Pre-specified|Level of Key Regulators|The level of key regulators of the MEK/MAPK and PI3K pathways and HSP90 and cell cycle regulators may determine the anti-tumor response to AZD6244 in vivo in multiple myeloma (MM).|Up to 20-30 hours after receiving the first dose of selumetinib|||||||
1421386|NCT01085214|Other Pre-specified|Changes in Bone Marrow Microenvironment|Effect of AZD6244 on the bone marrow microenvironment in MM.|Baseline to up to 20-30 hours after receiving the first dose of AZD6244|||||||
1421387|NCT01085214|Secondary|Progression Free Survival (PFS)|Median PFS in months. Progressive Disease (PD): Increase of >= 25% from baseline. Estimated using the method of Kaplan-Meier.|From registration to progression or death, assessed up to 2 years|All participants who received study treatment|||months||Full Range|Median
1421388|NCT01085214|Secondary|Incidence of Toxicity That May Be Treatment Emergent|Participants with Grade 3, 4, and 5 toxicities possibly, probably, or definitely related to study treatment. Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).|1 year, 11 months|All participants who received study treatment|||participants|||Number
1421389|NCT01085214|Secondary|Duration of Response|Mean duration of response in months. Estimated using the method of Kaplan-Meier.|From response to disease progression or death, assessed up to 2 years|All participants with response|||months||Full Range|Mean
1421390|NCT01085214|Primary|Overall Response Rate|Overall Response: Stringent Complete Response (sCR) + Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR).|Up to 2 years|All participants who received study treatment|||participants|||Number
1421391|NCT01085201|Secondary|Pain Levels During a Vaso-occlusive Event in Children and Adults With SCD.|Pain was measured using a standardized pain scale. The scale is a 10-cm visual analogue scale (10 cm-long line printed on white paper), where 0 is no pain and 10 is maximum pain. Participants were asked to indicate their pain level by marking on the line prior to each blood draw.|pre-drug to 54 hours|The number of participants was determined per protocol following a 3+3 design. Stages 1, 2 and 2b were excluded because this outcome measure is specific to the experience of a vaso-occlusive event, which was studied in Stages 3 and 4.|||units on a scale||Standard Deviation|Median
1421392|NCT01085201|Secondary|Percentage of Activated iNKT Cells and/or Activation Markers on iNKT Cells in Individuals With SCD.|Percentage of activated iNKT cells after receiving a 24-hour infusion of Lexiscan was compared to pre-drug. iNKT cell activation was evaluated using antibodies targeting the p65 subunit of nuclear factor-kappa B (phospho-NF-kB p65). Measures are given as percentage of change in phospho-NF-kB p65 activation in iNKT cells compared to pre-drug after a 24-hour infusion. iNKT cell activation in Stages 1, 2b, and 4 was not analyzed (see analysis population description).|pre-drug to 54 hours|The number of subjects was determined per protocol. Stage 1 was excluded as the goal was to determine the optimal markers for iNKT cells. Only 4 subjects were analyzed in Stage 2 because 24-hour samples were not obtained for 2 subjects. Stages 2b and 4 were not completely analyzed because these stages were completed early after studying 3 subjects.|||percentage of change in activation||Standard Deviation|Median
1421393|NCT01085201|Primary|Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD.|"Per protocol, Lexiscan was considered safe if well tolerated based on number of DLTs reported. Stage 1 of the study was a 3+3 dose escalation study. Three doses were tested: 0.24 mcg/kg/hr (dose level 0), 0.6 mcg/kg/hr (dose level 1), and 1.44 mcg/kg/hr (dose level 2). Dose escalation continued until 6 participants were treated at the maximum planned dose (dose level 2). We studied a total of 15 patients in Stage 1. In Stages 2 and 3, if at least 2/3 participants tolerated the dose, an additional 3 participants were studied. We studied 6 participants in each of stages 2 and 3. In stage 2b, Lexiscan was studied for a longer (48 hr) duration in 3 participants. In stage 4, Lexiscan was studied in 3 pediatric participants."|30 to 54 hours plus 30-day follow-up|The number of participants was determined per protocol following a 3+3 design. In Stages 2b and 4, we received permission from the FDA, IRB, and DSMB to study only 3 subjects because we did not observe any prior DLT. One patient enrolled in Stage 2b withdrew consent during the infusion due to an unrelated toothache, and was excluded from analysis.|||number of DLT|||Number
1421399|NCT01085136|Primary|Progression Free Survival (Part B)|"Progression free survival (PFS) time as determined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 from day of randomization until disease progression or death for patients randomised to combination therapy with afatinib plus paclitaxel or to investigator's choice of chemotherapy.~Median was calculated from the Kaplan−Meier curve."|From randomization until disease progression or death; Up to 32 months|Randomised Set: This analysis set consist of all randomised patients irrespective of whether treated or not.|||Months||95% Confidence Interval|Median
1421400|NCT01085045|Secondary|Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
1421401|NCT01085045|Secondary|Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
1421402|NCT01085045|Secondary|Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
1421403|NCT01085045|Secondary|Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7|Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters / Minute||95% Confidence Interval|Least Squares Mean
1421404|NCT01085045|Secondary|12 hr Post-dose Trough FEV1 on Day 7|12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
1421405|NCT01085045|Secondary|Change in Morning Pre-dose FEV1 on Day 7|Change from Baseline in morning pre-dose FEV1 on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
1421406|NCT01085045|Secondary|Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1|Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%|Day 1|MITT Population - not including the 4 sentinel patients.|||Percentage of Participants|||Number
1421407|NCT01085045|Secondary|Time to Onset of Action >=10% Improvement in FEV1 on Day 1|Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%|Day 1|MITT Population - not including the 4 sentinel patients.|||Participants|||Number
1421408|NCT01085045|Secondary|Peak Change From BL IC on Day 7|Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
1421409|NCT01085045|Secondary|Peak Change From BL in Inspiratory Capacity on Day 1|Peak change from Baseline in Inspiratory Capacity (IC) on Day 1|Day 1|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
1421410|NCT01085045|Secondary|Peak Change From BL in FEV1 on Day 7|Peak change from Baseline (BL) in FEV1 on Day 7|Day 7|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
1421411|NCT01085045|Secondary|Peak Change From BL in FEV1 on Day 1|Peak change from Baseline in FEV1 on Day 1|Day 1|MITT Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
1421412|NCT01085045|Primary|FEV1 AUC 0-12 on Day 7|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration|"Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7"|Modified Intent to Treat (MITT) Population - not including the 4 sentinel patients.|||Liters||95% Confidence Interval|Least Squares Mean
1421413|NCT01085006|Secondary|Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery||First 24 hours|||||||
1421414|NCT01085006|Primary|The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward||During the procedure and within 2 hours afterwards||||ml||Full Range|Median
1421415|NCT01084759|Secondary|Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||participants|||Number
1421416|NCT01084759|Primary|Time to PSA Progression|Time to a PSA increase above the PSA level obtained after 3 months on testosterone treatment over two successive measurements 2 weeks apart.|2 years||||days||Full Range|Median
1421417|NCT01084759|Primary|Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.||3 months||||Percentage of Participants||95% Confidence Interval|Number
1421418|NCT01084707|Primary|Average Concentration|Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)|During the last dosing interval (hour 11-12 post-dose)|ITT|||(ng/ml)||Standard Deviation|Geometric Mean
1421419|NCT01084707|Secondary|Nicotine Plasma Concentration|The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment|One hour after start of treatment|ITT|||(ng/ml)||Standard Deviation|Geometric Mean
1421420|NCT01084707|Secondary|Peak-Trough Fluctuation|Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)|During the last dosing interval (hour 11-12 post-dose)|ITT|||Percent Fluctuation||Standard Deviation|Mean
1421421|NCT01084707|Secondary|Minimum Plasma Concentration|The minimum nicotine plasma concentration during the last dosing interval (Cmin)|During the last dosing interval (hour 11-12 post-dose)|ITT|||(ng/ml)||Standard Deviation|Mean
1421422|NCT01084707|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During the last dosing interval (hour 11-12 post-dose)|ITT|||(minutes)||Full Range|Median
1421423|NCT01084707|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During the last dosing interval (hour 11-12 post-dose)||||(ng/ml)||Standard Deviation|Geometric Mean
1422187|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 6 Months||6 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).|||participants|||Number
1421424|NCT01084668|Secondary|Tolerability and Safety Assessed by Collection and Classification of Adverse Reactions|Tolerability and safety were assessed by collecting adverse events during the course of the study up to 70 days following the last dose of physician-prescribed adalimumab. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|From the time of participant consent until 70 days after last dose of study drug|Analysis was performed on the All Treated population.|||participants|||Number
1421425|NCT01084668|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nails are graded for nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Per nail, the NAPSI score ranges from 0 (no nail psoriasis) to 4 (most severe nail psoriasis).|Inclusion visit (Week 0), Week 4, Week 36, and Week 52|Analysis was performed using an observed case approach. For the All Treated population, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 34, 30, 24, and 25 participants, respectively. For the Subgroup with nail psoriasis, NAPSI was assessed at Weeks 0, 4, 36, and 52 in 18, 16, 12, and 13 participants, respectively.|||units on a scale||Standard Deviation|Mean
1421426|NCT01084668|Secondary|Dermatology Life Quality Index (DLQI) Score|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. DLQI score was assessed at Weeks 0, 4, 36, and 52 in 36, 34, 26, and 27 participants, respectively.|||units on a scale||Standard Deviation|Mean
1421427|NCT01084668|Primary|Reduction in Psoriasis Area and Severity Index Score of at Least 75% (PASI75)|PASI75 is the number of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52 (final visit). PASI score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0) to Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI response was assessed in 26 participants at Week 52.|||participants|||Number
1421428|NCT01084668|Primary|Psoriasis Area and Severity Index (PASI) Score|Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).|Inclusion visit (Week 0), Week 4, Week 36, Week 52|Analysis was performed on the All Treated population using an observed case approach. PASI score was assessed at Weeks 0, 4, 36, and 52 in 41, 36, 28, and 27 participants, respectively.|||units on a scale||Standard Deviation|Mean
1421429|NCT01084603|Primary|Bioavailability|A measure of how much of the drug reaches a person’s bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug’s blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).|12 hours||||h*ng/ml||Standard Deviation|Geometric Mean
1421430|NCT01084603|Secondary|Released Nicotine|The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing|After 30 minutes' chewing|ITT|||(ng/ml)||Standard Deviation|Mean
1421431|NCT01084603|Secondary|Terminal Elimination Rate Constant|The terminal nicotine elimination rate constant (Lamda z)|During 12 hours after start of administration|ITT|||(1/hr)||Standard Deviation|Mean
1421432|NCT01084603|Secondary|Time of Maximum Concentration|The time at which maximum concentration is reached (Tmax)|During 12 hours after start of administration|ITT|||(hours)||Full Range|Median
1421433|NCT01084603|Secondary|Nicotine Plasma Concentration|Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)|During 10 minutes after start of administration|ITT|||(h*ng/ml)||Standard Deviation|Geometric Mean
1421434|NCT01084603|Primary|Maximum Plasma Concentration|Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)|During 12 hours after start of administration|ITT|||(ng/ml)||Standard Deviation|Geometric Mean
1421435|NCT01084551|Secondary|Average Sleep Time in a Week|Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF|||Hours||Standard Deviation|Mean
1421436|NCT01084551|Secondary|Nocturnal Awakenings Due to RLS Symptoms in a Week|Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of days/week with awakening||Standard Deviation|Mean
1421437|NCT01084551|Secondary|Average Duration of RLS Symptoms in the Evening and Night in a Week|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF|||Hours||Standard Deviation|Mean
1421438|NCT01084551|Secondary|Incidence of RLS Symptoms in the Evening and Night|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation * 100%.|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of days/week with symptoms||Standard Deviation|Mean
1421439|NCT01084551|Secondary|Average Duration of RLS Symptoms|Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.|Baseline, the end of dose-titration/dose-maintenance period (weeks 13)|FAS, LOCF|||Hours||Standard Deviation|Mean
1421440|NCT01084551|Secondary|Incidence of RLS Symptoms|Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week* 100%|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of days with RLS symptom||Standard Deviation|Mean
1422188|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 3 Months||3 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).|||participants|||Number
1421441|NCT01084551|Secondary|Each Item of IRLS (10 Items)|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).~Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||percentage of participants|||Number
1421442|NCT01084551|Secondary|The Pittsburgh Sleep Quality Index (PSQI)|"Change of PSQI from baseline to the end of dose-titration/dose-maintenance period.~PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates “no difficulty” and 21 indicates “severe difficulty”. A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
1421443|NCT01084551|Secondary|Patient Global Impression (PGI) Improvement|"PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||Percentage of Participants|||Number
1421444|NCT01084551|Secondary|Clinical Global Impression (CGI) Improvement|"CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|FAS, LOCF|||Percentage of Participants|||Number
1421445|NCT01084551|Primary|International Restless Legs Syndrome Rating Scale (IRLS) Total Score|"Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually ‘very severe’) to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, the end of dose-titration/dose-maintenance period (week 13)|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
1421446|NCT01084538|Secondary|Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.|Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.|Baseline through 12 months|Analysis was based on the number of subjects included in the full analysis set (N=175).|||participants|||Number
1421447|NCT01084538|Secondary|Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL|The average time (measured in days) to achieve target iPTH levels.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.|||Days||Standard Deviation|Mean
1421448|NCT01084538|Secondary|Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)|Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.|Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.|||percentage of participants|||Number
1421449|NCT01084538|Primary|Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline||Baseline through 12 months|Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.|||percentage of participants|||Number
1421450|NCT01084278|Primary|Percentage of Colchicine Dose Recovered in Dialysate|The cumulative percentage of the colchicine dose recovered in dialysate.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.|||percent dose||Standard Deviation|Mean
1421451|NCT01084278|Primary|Dialysis Clearance of Colchicine (CLD)|The dialysis clearance of colchicine, calculated as amount of colchicine recovered in dialysate / AUCt2-t1 where t1 and t2 are the times of the start and end of hemodialysis.|Day 15, post-dose during dialysis|ESRD participants on dialysis, where data were available.|||L/h||Standard Deviation|Mean
1421452|NCT01084278|Primary|Renal Clearance of Colchicine (CLR)|Renal clearance of colchicine, calculated as Ae(0 t)/AUC 0-t.|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/hr||Standard Deviation|Mean
1421453|NCT01084278|Primary|Percentage of Colchicine Dose Excreted in Urine up to the Final Collection Time|The cumulative percentage of the colchicine dose excreted in urine up to the final collection time, calculated as Ae(0-t) × 100/dose|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||percent of dose||Standard Deviation|Mean
1421454|NCT01084278|Primary|Amount of Colchicine Excreted in Urine (Ae[0-t])|The amount of colchicine excreted in urine during the post-dose collection, calculated as the sum of the amounts in the individual collection intervals (Ae).|Pre-dose on Day 1 and up to 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||mg||Standard Deviation|Mean
1421487|NCT01084148|Secondary|Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B|"At the end of treatment (day 133), patients assessed their overall agreement on the local tolerance of the test product, using a 4-point scale, as follows :~= very satisfactory~= satisfactory~= poorly satisfactory~= not satisfactory at all"|133 days||||participants|||Number
1421455|NCT01084278|Primary|Weight-adjusted Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞) and normalized to body weight (in kilograms).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/hr/kg||Standard Deviation|Mean
1421456|NCT01084278|Primary|Apparent Total Body Clearance of Colchicine|The apparent total body clearance after administration of colchicine, calculated as Dose/AUC(0-∞).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/hr||Standard Deviation|Mean
1421457|NCT01084278|Primary|Weight-adjusted Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel), and normalized to body weight.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L/kg||Standard Deviation|Mean
1421458|NCT01084278|Primary|The Apparent Total Volume of Distribution After Administration (V-area/F)|The apparent total volume of distribution after administration of colchicine, calculated as Dose / (AUC0-∞ × Kel).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||L||Standard Deviation|Mean
1421459|NCT01084278|Primary|Apparent First-order Terminal Elimination Half-life (t½)|The apparent first-order terminal elimination half-life was calculated as 0.693/Kel.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||hr||Standard Deviation|Mean
1421460|NCT01084278|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel)|Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve for colchicine. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero plasma concentrations).|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||1/hr||Standard Deviation|Mean
1421461|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0 - ∞)|The area under the plasma concentration versus time curve extrapolated to infinity. AUC 0 - ∞ is calculated as the sum of total AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose.|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||ng*h/mL||Standard Deviation|Mean
1421462|NCT01084278|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration, calculated by the linear trapezoidal method.|Day 1 and Day 15 (ESRD patients only), predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||ng*h/mL||Standard Deviation|Mean
1421463|NCT01084278|Primary|Time to Maximum Plasma Concentration (Tmax)|The time to reach the maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||hours||Standard Deviation|Mean
1421464|NCT01084278|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration of colchicine in the plasma.|Day 1 and Day 15 (for ESRD patients only) pre-dose and at 0.5, 1, 1.5 , 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 hours post dose|Per Protocol Analysis Population - Participants renal function was characterized by CrCl using the Cockcroft-Gault equation as healthy (≥90 mL/min), and characterized by Modified Diet in Renal Disease (MDRD) equations as mild (60 - 89 mL/min), moderate (30 - 59 mL/min), severe (15 - 29 mL/min), and ESRD patients requiring dialysis.|||ng/mL||Standard Deviation|Mean
1448004|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT|||parts per billion (ppb)||Standard Deviation|Mean
1421465|NCT01084265|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Day 14|Safety analysis set included all participants who received investigational drug for at least one time.|||participants|||Number
1421466|NCT01084265|Secondary|Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Clinical pregnancy was defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
1421467|NCT01084265|Secondary|Average Change of E2 Level in Participants Per Day up to Day 14|The average change was calculated by assessing the E2 levels on 4 timepoints until day 14 (day 1, day 5, day 10, day 14 [hCG administration day]).|up to Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||pg/mL per day||Standard Deviation|Mean
1421468|NCT01084265|Secondary|Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||follicles||Standard Deviation|Mean
1421469|NCT01084265|Secondary|Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||follicles||Standard Deviation|Mean
1421470|NCT01084265|Primary|Number of Participants Who Refused to Take hCG Injection|Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
1421471|NCT01084265|Primary|Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
1421472|NCT01084265|Primary|Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter||Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
1421473|NCT01084265|Primary|Number of Participants Who Met Both Index 1 and Index 2|The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.|Day 14|Per protocol set included all participants who completely met all the requirements of clinical trial protocol.|||participants|||Number
1421474|NCT01084239|Secondary|Rate of ED Discharge|Direct discharge from Emergency Department|Duration of stay in the hospital during the initial visit||||participants|||Number
1421475|NCT01084239|Secondary|Cost-effectiveness|Total cost during index hospitalization|Duration of stay in the hospital during the initial visit||||US Dollars||Standard Deviation|Mean
1421476|NCT01084239|Secondary|MACE|Major Adverse Cardiovascular Events, All though these events are called MACE they do not qualify as adverse or serious adverse events. As these events are expected in some individuals in this population. Only MACE that occured within 72 hours after hospital discharge were considered serious adverse events in this trial. There were no such events.|72 hours after discharge up to 28 days after enrollment.||||events|||Number
1421477|NCT01084239|Secondary|Healthcare Utilization|Number of patients with diagnostic testing (CCTA, ETT, SPECT, stress echocardiography, and invasive coronary angiography)|Duration of stay in the hospital during the initial visit||||participants|||Number
1421478|NCT01084239|Secondary|Time to Diagnosis||Time from ED arrival to first positive test (all tests except Echocardiography Rest and including troponins ) if discharge diagnosis is ACS, otherwise time to performance of last test (all tests except Echocardiography Rest and including troponins ).||||hours||Standard Deviation|Mean
1421479|NCT01084239|Primary|Length of Hospital Stay||Duration of stay in the hospital during the initial visit||||hours||Standard Deviation|Mean
1421480|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to 12 Months|IgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months|Baseline and 12 months||||kUa/L||Full Range|Median
1421481|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to 6 Months|Serum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months|Baseline and 6 months||||kUa/L||Full Range|Median
1421482|NCT01084174|Secondary|Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)||Baseline to end of dose build-up (up to 16 weeks)||||kUa/L||Full Range|Mean
1421483|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to 12 Months|IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months|Baseline and 12 months|One participant in the Active SLIT/Placebo OIT arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 12.|||mga/L||Full Range|Median
1421484|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to 6 Months|IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months|Baseline and 6 months|One participant in the Active sublingual immunotherapy (SLIT)/Placebo oral immunotherapy (OIT) arm and 4 participants in the Active OIT/Placebo SLIT arm discontinued prior to month 6.|||mga/L||Full Range|Median
1421485|NCT01084174|Secondary|Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)|Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)|Baseline and end of dose build-up (up to 16 weeks)||||mga/L||Full Range|Median
1421488|NCT01084148|Primary|Treatment Response of Xerosis|"Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale:~0 = smooth skin~= patches of fine, powdery scales~= diffuse ashy appearance with many fine scales~= moderate scaling with beginning cracks~= intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I)."|28 days|One patient in V0034 CR 01B Vehicle arm randomized but not treated|||participants|||Number
1421489|NCT01084135|Secondary|Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)|The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a parent report measure of executive function behaviors in children in their home setting. It yields an overall score (Global Executive Composite, GEC) that is based on its five clinical scales. Raw scores range from 63 to 189. Higher scores suggest that an individual’s executive function skills are more problematic. In this study, the change between each subject’s raw score at Baseline and the Final Visit was computed for the Global Executive Composite. A decline in raw scores from Baseline to the Final Visit indicates improvement.|Baseline and Final (Week 20) visit|All subjects who completed the 20 week period were included in analysis except for 1 subjects whose form was completed incorrectly.|||units on a scale||Standard Deviation|Mean
1421490|NCT01084135|Primary|Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form)|The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. In this study, the change between each subject’s ABC at Baseline and the Final Visit was computed. A rise in standard scores from Baseline to the Final Visit indicates improvement.|Baseline & Study termination (Week 20)|All subjects who completed the 20 week period were included in analysis except for 2 subjects whose form was completed incorrectly.|||units on a scale||Standard Deviation|Mean
1421491|NCT01084083|Secondary|Primary Clinical Response Rate|Primary clinical response rate is defined as the proportion of patients with complete response or partial response at their primary sites after induction therapy. Response status for the primary site was classified by clinical examination using endoscopy. If, however, the clinical response status of the primary was unclear based on endoscopy, then the CT or MRI (required at the end of induction) was used to determine status of the primary. If clinical and radiological evaluation of the primary was unclear, a biopsy was considered at the discretion of the treating physician.|assessed within 14 days after delivery of the third cycle of induction therapy|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
1421492|NCT01084083|Secondary|24-months Overall Survival|OS was defined as the time from registration to death, or censored at last date known alive. Kaplan-Meier method was used to estimate the overall survival rate at 24 months.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
1421493|NCT01084083|Primary|24-month Progression-free Survival|24-month progression-free survival is defined as the proportion of patients who were alive and progression-free at 24 months post registration. The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.|assessed within 14 days after delivery of the third cycle of induction therapy, and 8 weeks and 6 months after completion of concurrent therapy, then every 6 months until progression or until 3 years from study entry|patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites|||percentage of participants||95% Confidence Interval|Number
1421494|NCT01084005|Secondary|Number of Patients With Rescue Therapy|The use of rescue therapy was planned for patients failing to achieve preset criteria based on glucose levels during the randomised treatment period of the trial|week 24|FAS (OC)|||Number of patients|||Number
1421495|NCT01084005|Secondary|Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24|The percentage of patients with an HbA1c reduction of ≥0.5% at week 24 from baseline was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%|Baseline and week 24|FAS (NCF)|||percentage of patients|||Number
1421496|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 were calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and week 24|FAS (NCF)|||percentage of patients|||Number
1421497|NCT01084005|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%. Only patients with baseline HbA1c >= 7%|Baseline and week 24|FAS with baseline HbA1c >=7% and non-completers considered as failure imputation (NCF)|||percentage of patients|||Number
1421498|NCT01084005|Secondary|FPG Change From Baseline to Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 18|FAS (OC)|||mg/dL||Standard Error|Mean
1421499|NCT01084005|Secondary|FPG Change From Baseline to Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 12|FAS (OC)|||mg/dL||Standard Error|Mean
1421500|NCT01084005|Secondary|FPG Change From Baseline to Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment-adjusted for baseline HbA1c, baseline FPG and prior use of insulin, week repeated within patient and week by treatment interaction.|Baseline and week 6|FAS Observed cases (OC)|||mg/dL||Standard Error|Mean
1448005|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 2 Hours|Using portable gas chromatograph|2hr|ITT|||parts per billion (ppb)||Standard Deviation|Mean
1421502|NCT01084005|Secondary|HbA1c Change From Baseline to Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 18|FAS (LOCF)|||Percent||Standard Error|Mean
1421503|NCT01084005|Secondary|HbA1c Change From Baseline to Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 12|FAS (LOCF)|||Percent||Standard Error|Mean
1421504|NCT01084005|Secondary|HbA1c Change From Baseline to Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 6|FAS (LOCF)|||Percent||Standard Error|Mean
1421505|NCT01084005|Primary|HbA1c Change From Baseline to Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.|Baseline and week 24|FAS consisting of all randomised patients who were treated with at least one dose of study drug, had a baseline, and at least 1 on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1421506|NCT01083979|Secondary|Bladder Appearance|The secondary objective to assess treatment efficacy will compare the number of bladder ulcers pre-treatment to the number of ulcers visualized at 12 weeks, the end of the study.|Baseline to 12 Weeks||||Ulcers|||Number
1421507|NCT01083979|Primary|Change in Symptom and Problem Severity|The primary objective is to determine the impact of 4 weekly bladder instillations of liposomes on symptoms in one patient with ulcerative interstitial cystitis (IC). The primary endpoint will be assessed at the end of the study, 8 weeks after the last bladder instillation, and will be measured by the O'Leary-Sant IC Symptom and Problem Indices (ICSI-PI) questionnaire. The ICSI is composed of 4 questions that address the occurrence of IC symptoms, specifically urinary urgency, frequency, nocturia, and bladder pain. Scores range from 0 (Not at All) to 5 (Almost Always). The IC Problem Indices questionnaire is also composed of 4 questions. Each question asks the patient to indicate how big a problem each of the 4 symptoms are to them. Scores range from 0 (No Problem) to 4 (Big Problem). Responses to all 8 questions are added together to create a total ICSI-PI score. The total ICSI-PI scores ranges from 0 to 36. A lower score indicates less IC symptoms and/or related problem|Baseline to 12 weeks||||units on a scale|||Number
1421508|NCT01083901|Secondary|Change in Lower Body Strength|Strength was measured using the one-repetition maximum method. Lower body strength was a composite of knee flexion, knee extension, and leg press strength.|16 weeks||||lbs||Standard Error|Mean
1421509|NCT01083901|Secondary|Changes in Upper Body Strength.|Strength was measured using the one-repetition maximum method. Upper body strength was a composite of bench press, overhead press, seated row, and lateral pull-down strength.|16 weeks||||lbs||Standard Error|Mean
1421510|NCT01083901|Secondary|Change in Total Body Fat Mass|Change from baseline to 16 weeks in total body fat mass.|16 weeks||||kg||Standard Error|Mean
1421511|NCT01083901|Primary|Change in Total Body Fat-free Mass|change from baseline to 16 weeks in fat-free mass measured by DXA (Hologic Discovery W, version 12.6)|16 weeks|All participants with baseline and 16 week data were included in the analysis (i.e., intention-to-treat).|||kg||Standard Error|Mean
1421512|NCT01083849|Secondary|Mean Calcium-Phosphate Product Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||mmol²/l²||Standard Deviation|Mean
1421513|NCT01083849|Secondary|Mean Intact Parathormone (iPTH) Levels by Visit||Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||pmol/L||Standard Deviation|Mean
1421514|NCT01083849|Primary|Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 months|Participants with a determined chronic kidney disease (CKD) stage|||days||Standard Deviation|Mean
1421515|NCT01083849|Secondary|Mean Duration of Disability by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||days||Standard Deviation|Mean
1421516|NCT01083849|Secondary|Mean Duration of Hospitalization by Visit||Months 0, 3, 6, 9, and 11|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||days||Standard Deviation|Mean
1421517|NCT01083849|Secondary|Number of Participants With Elevated Calcium-Phosphorus Product|Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||participants|||Number
1421518|NCT01083849|Secondary|Number of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||participants|||Number
1421546|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8||||mmol/24h||Standard Deviation|Mean
1421519|NCT01083849|Secondary|Number of Participants With Hypercalcemia|Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit.|Months 0, 3, 6, 9, and 12|The Pre-Dialysis and Dialysis groups were split into subgroups. Secondary endpoint investigations were done for the 733 participants in these Pre-Dialysis or Dialysis subgroups; 26 out of the 759 participants had a missing subgroup allocation.|||participants|||Number
1421520|NCT01083849|Primary|Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months|Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL).|Up to 12 Months|Participants with a determined chronic kidney disease (CKD) stage|||percentage of participants|||Number
1421521|NCT01083810|Secondary|Change in Absolute CD4 Cell Count [CD4+ Cells/µL]|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with CD4+ measurements at Baseline and any subsequent time point are included.|||CD4+ cells/µL||Standard Deviation|Mean
1421522|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA >500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
1421523|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
1421524|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
1421525|NCT01083810|Secondary|Percentage of Patients With HIV-1 RNA <50 Copies/ml|All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.|Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks|All participants with HIV-1 RNA measurements at Baseline and any subsequent time point are presented, including those who discontinued due to virologic failure.|||Percentage of participants|||Number
1421526|NCT01083810|Primary|Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs|Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.|Baseline and at any timepoint where testing is possible|All participants with resistance testing at baseline and follow-up are presented.|||Participants|||Number
1421527|NCT01083771|Secondary|To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet|Post diet waist circumference|8 weeks||||centimeters||Standard Deviation|Mean
1421528|NCT01083771|Primary|Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet|Based on overall percentage change at baseline versus post diet|eight weeks||||percentage of change||Standard Deviation|Mean
1421529|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|End of treatment||||% of participants w/ controlled disease|||Number
1421530|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 8||||% of participants w/ controlled disease|||Number
1434153|NCT00979576|Primary|Dose Limiting Toxicities|Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course|During the first course, 21 days|Treated set|||Participants|||Number
1421531|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation.|week 4||||% of participants w/ controlled disease|||Number
1421532|NCT01083758|Secondary|Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient’s Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient’s Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.|week 2||||% of participants w/ controlled disease|||Number
1421533|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and end of treatment (up to 8 weeks)||||Percentage change||Standard Deviation|Mean
1421534|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 8||||Percentage change||Standard Deviation|Mean
1421535|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|Baseline and week 4||||percentage change||Standard Deviation|Mean
1421536|NCT01083758|Secondary|Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.|Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score(ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome).|week 2||||Percentage change||Standard Deviation|Mean
1421537|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|End of treatment||||percentage of participants|||Number
1421538|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 8||||percentage of participants|||Number
1421539|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation.|week 4||||percentage of participants|||Number
1421540|NCT01083758|Secondary|Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator’s Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.|Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.|week 2||||percentage of participants|||Number
1421541|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 8||||ng/L||Standard Deviation|Mean
1421542|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and end of treatment (up to 8 weeks)||||mmol/g||Standard Deviation|Mean
1421543|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 8||||mmol/g||Standard Deviation|Mean
1421544|NCT01083758|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.|Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.|Baseline and week 4||||mmol/g||Standard Deviation|Mean
1421545|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)||||mmol/24h||Standard Deviation|Mean
1448006|NCT00867035|Secondary|Concentration of Hydrogen Sulfide (H2S) in Mouth Air at 1 Hour|Using portable gas chromatograph|1hr|ITT|||parts per billion (ppb)||Standard Deviation|Mean
1421547|NCT01083758|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4||||mmol/24h||Standard Deviation|Mean
1421548|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and end of treatment (up to 8 weeks)||||mmol/L||Standard Deviation|Mean
1421549|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 8||||mmol/L||Standard Deviation|Mean
1421550|NCT01083758|Primary|Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.|Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.|Baseline and week 4||||mmol/L||Standard Deviation|Mean
1421551|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 8|Per protocol population|||participants|||Number
1421552|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.|week 4|Per Protocol Population|||participants|||Number
1421553|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8|Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|week 8|Per Protocol Population|||participants|||Number
1421554|NCT01083758|Secondary|Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8|Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8|Baseline and week 4||||ng/L||Standard Deviation|Mean
1421555|NCT01083758|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4|Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.|Week 4|Per Protocol Population (based on the Full Analysis Set, but excluding subjects who did not apply any study medication, meet the inclusion criterion concerning adrenal function at baseline, or provide any results for the ACTH-challenge test after receiving study treatment)|||participants|||Number
1421556|NCT01083758|Primary|Percentage of Subjects With Adverse Drug Reactions (ADRs)|Adverse events for which the investigator did not describe the causal relationship to IP as not related|Throughout trial, up to 8 weeks||||percentage of participants|||Number
1421557|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set|||Percentage of participants|||Number
1421558|NCT01083732|Secondary|Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination|"Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.~Clinically Relevant Abnormalities for Laboratory Parameters were reported."|During the treatment period, Up to 6 days|Treated set|||Percentage of participants|||Number
1421559|NCT01083732|Secondary|Global Assessment of Tolerability of Study Medication- Taste Assessment|The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.|Day 1 (immediately after dosing)|Treated set|||Percentage of participants|||Number
1421560|NCT01083732|Secondary|Percentage of Patients With Any Adverse Events During the Treatment Period|Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set|||Percentage of participants|||Number
1421561|NCT01083732|Primary|Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.|Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered & which was not directly attributable to the patient’s underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.|Up to 6 days|Treated set|||Percentage of participants|||Number
1421572|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 951 BS|Plasma concentration of metabolite BIBR 951 BS|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1424304|NCT01061333|Primary|Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes|Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge|Pre-allergen challenge and 5 minutes post allergen challenge||||Fold change over baseline||Standard Deviation|Geometric Mean
1421562|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1421563|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||hours||Full Range|Median
1421564|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)|Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1421565|NCT01083732|Primary|AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)|"AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1421566|NCT01083732|Primary|Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)|"tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).~Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2)."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||hours||Full Range|Median
1421567|NCT01083732|Primary|Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)|Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1421568|NCT01083732|Primary|Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)|||seconds||Standard Deviation|Mean
1421569|NCT01083732|Primary|Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation|at predose and 2 and 10 h after intake of study medication.|PKS (evaluable cases)|||seconds||Standard Deviation|Mean
1421570|NCT01083732|Primary|Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.|Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.|at predose and 2 and 10 h after intake of study medication.|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||seconds||Standard Deviation|Mean
1421571|NCT01083732|Primary|Plasma Concentration of Metabolite BIBR 1087 SE|Plasma concentration of metabolite BIBR 1087 SE|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1421573|NCT01083732|Primary|Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)|"Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).~Some values are NA because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules."|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1421574|NCT01083732|Primary|Plasma Concentration of Free Dabigatran (BIBR 953 ZW).|Plasma concentration of free dabigatran (BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|PKS (evaluable cases)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1421575|NCT01083732|Primary|Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)|Plasma concentration of total dabigatran (SUM BIBR 953 ZW)|At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate|"Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.~PKS (evaluable cases)"|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1421576|NCT01083706|Secondary|Incidence of Grades II-IV Graft-versus-host Disease (GVHD)||6 months||||Participants|||Count of Participants
1421577|NCT01083706|Secondary|Rate of Response by IWG Criteria|Count of participants achieving a complete or partial remission at 6 months.|6 months||||Participants|||Count of Participants
1421578|NCT01083706|Primary|Overall Survival|Count of surviving participants at 6 months.|6 months||||Participants|||Count of Participants
1421579|NCT01083693|Secondary|C-Reactive Protein|The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1421580|NCT01083693|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline, months 3,6,9,12|Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1421581|NCT01083693|Secondary|Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
1421582|NCT01083693|Secondary|Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only|Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
1421583|NCT01083693|Secondary|Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness|Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]).|||Units on a scale||Standard Deviation|Mean
1421584|NCT01083693|Secondary|DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale|The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).|Baseline,months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
1421585|NCT01083693|Primary|EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression|"European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best).~In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status."|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
1421586|NCT01083693|Primary|SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain|Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [participants who discontinued the study early]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.|||Units on a scale||Standard Deviation|Mean
1421587|NCT01083693|Primary|RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).|Baseline, months 3,6,9,12|Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination [for participants who discontinued the study early]) in each disease group.|||Units on a scale||Standard Deviation|Mean
1421588|NCT01083680|Secondary|Compliance With the Self-injection Via the Humira®-PEN|Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Compliance data were not collected.||||||
1421589|NCT01083680|Secondary|4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time|The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores < 5 indicate remission, 5 – 7 indicate mild disease, 8 – 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||units on a scale||Standard Deviation|Mean
1421590|NCT01083680|Primary|Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)|"An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.~For more details on adverse events please see the AE section below."|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Analysis included safety analysis population with incidence of greater than 1% during the study.|||percentage of participants|||Number
1421591|NCT01083680|Primary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants|The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.|Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||units on a scale||Standard Deviation|Mean
1421592|NCT01083680|Primary|Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time|The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and > 450 to define severely active disease.|Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||percentage of participants|||Number
1421593|NCT01083680|Primary|Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit|The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: < 150 to indicate remission, 150 – 219 to define mildly active disease, 220 – 450 to define moderately active disease, and > 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.|Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Effectiveness analyses included all participants with evaluable data.|||units on a scale||Standard Deviation|Mean
1421594|NCT01083667|Secondary|Appel ALS Score|an objective and timed measurement of strength and function of subjects including muscle testing, respiratory function and fine motor function, all summed together for a total value, and is measured at baseline, visit 2, visit 6 and end of study. The scale ranges from 30 in a healthy person to to 164 in a maximally impaired person; an increase in score indicates progression and is expected in disease progression.|Week 0, 6, 18, and end of study|22 subjects completed to visit 9 and had a final score for Appel Score. Reported is the mean change from Baseline to week 36|||units on a scale||95% Confidence Interval|Number
1421595|NCT01083667|Primary|Mean Change in SOD1 CSF|Reported change in mean SOD1 CSf from baseline to visit 6 (week 18) and end of study for all subjects who completed the measure|baseline, Visit 6 week 18, end of study|24 subjects completed up to visit 6 and 21 subjects for final study visit. Reported is the change in SOD1 CSF from baseline to week 36.|||ng/ml||95% Confidence Interval|Mean
1421596|NCT01083654|Primary|7-day Point-prevalence Smoking Abstinence|Self-reported abstinence (versus smoking) during the past 7 days at the 6-month follow-up time-point, verified by exhaled breath carbon monoxide (CO) measurement (< 10 parts per million CO is indicative of no smoking).|6 months||||Number of abstinent participants|||Number
1421597|NCT01083641|Secondary|Median Overall Survival (OS)||Up to 4 years||||months||95% Confidence Interval|Median
1421598|NCT01083641|Secondary|Progression-free Survival (PFS)||Up to 4 years||||months||95% Confidence Interval|Median
1421599|NCT01083641|Secondary|Clinical Benefit (CB)|Defined as complete response, partial response, or stable disease at > 16 weeks|Up to 4 years||||Participants|||Count of Participants
1421600|NCT01083641|Primary|Determine Tumor Objective Response (OR) Rates|OR=complete response (CR) + partial response (PR) as defined by RECIST version 1.1, where CR=disappearance of all target lesions, and PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 4 years||||percentage of participants||95% Confidence Interval|Number
1421601|NCT01083602|Secondary|Over All Survival|Kaplan Meier estimates- median time to event|24 weeks|FAS|||Days||95% Confidence Interval|Median
1421602|NCT01083602|Secondary|Time to Progression|Time from randomization until objective tumor progression; does not include deaths-- Kaplan-Meier estimates|24 weeks|FAS|||Days||95% Confidence Interval|Median
1421603|NCT01083602|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the date of first study treatment to first occurrence of documented progressive disease /relapse or death. Time from randomization until disease progression or death by Kaplan-Meier estimates|24 weeks|Full Analysis Set (FAS)|||days||95% Confidence Interval|Median
1421604|NCT01083602|Secondary|Time to Response (Greater Than or Equal to PR) Based on Investigator Assessment|Time to response is defined as the time from the date of first administration of study treatment to the date of first documented evidence of CR or nCR or PR (whichever status is recorded first). Patients who do not have a response of PR or better by the data cut-off date are censored.|after eight cycyles of treatment (24 weeks)|FAS|||Days||Standard Deviation|Mean
1421605|NCT01083602|Secondary|Responders to Treatment|The primary endpoint for this phase II study of patients with bortezomib-refractory MM is response after a maximum of 8 cycles of therapy as defined by the modified EBMT criteria.|after eight cycyles of treatment (24 weeks)|Full Analysis Set|||participants|||Number
1421606|NCT01083602|Primary|Overall Response Rate (PR+nCR+CR)|Overall response rate=(PR+nCR+CR) CR= < 5% plasma cells in bone marrow. No confirmation on bone marrow plasma cell (additional assessment) is needed to document CR except patients with non-secretory myeloma where the bone marrow examination must be repeated after an interval of at least 6 weeks, Absence of M-protein in serum and urine by immunofixation,nCR same as CR without out Absence of M-protein in serum and urine by immunofixation,PR+ 50% reduction of serum M-protein and sofft tissue Plasmacytomas all for more than 6 weeks.|after eight cycyles of treatment (24 weeks)|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1421607|NCT01083576|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults ages >= 17 years with measurable samples.|||hr/ML||Standard Deviation|Mean
1421608|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.|||1/ML||Standard Deviation|Mean
1421609|NCT01083576|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Paromomycin Alone Treatment had only 5 measureable samples on Day 1, and WR 279,396 had only 4 measureable samples on Day 20.|||hr||Standard Deviation|Mean
1421610|NCT01083576|Other Pre-specified|Serum Creatinine Levels|Blood creatinine was measured to assess possible nephrotoxicity associated with aminoglycosides|Day 1 and Day 20|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.|||mg/dL||Standard Deviation|Mean
1421611|NCT01083576|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples.|||ng*hr/mL||Standard Deviation|Mean
1421612|NCT01083576|Secondary|Pharmacokinetic Parameter: Tmax|Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults ages >= 17 years with measurable samples. Both groups had only 6 measureable samples each on Day 1.|||hr||Standard Deviation|Mean
1421613|NCT01083576|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults with measurable samples.|||ng/mL||Standard Deviation|Mean
1421614|NCT01083576|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|Days 1 and 20|Children ages 7 to 16|||ng/mL||Standard Deviation|Mean
1421617|NCT01083576|Secondary|Number of Participants Who Obtained a Modified Final Clinical Cure of All Lesions|Final cure as defined by the primary outcome measure AND and cure of all other lesions by Day 168. (100% re-epithelialization of all ulcerated lesions and resolution of all other type of lesions)|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.|||Participants|||Number
1421618|NCT01083576|Primary|Number of Participants Who Obtained Final Clinical Cure of Index Lesion|Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion.|168 days|All randomized subjects were included in the mITT Analysis. All subjects met criteria for the evaluable subset.|||Participants|||Number
1421619|NCT01083485|Secondary|Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets|To compare the use of rescue analgesia for the 2 groups (OXN 20/10mg tablets and OXY 20mg tablets) during the double blind treatment phase. Rescue medication was given (OXY Immediate Release, 5mg capsules) if the subjects pain score on the (Numeric Rating Scale (NRS), 0 (no pain) to 10 (worst possible pain)), was greater than or equal to 4. The value presented is the mean dose over the double blind phase.|Mean dose during the whole double blind treatment phase (2.5 days)|This is the per protocol population (PP), which is a subset of the full analysis population. The data presented is only for those subjects taking the higher dose (20/10 mg OXN or 20 mg OXY) in the study.|||mg of rescue analgesia||Standard Deviation|Mean
1421620|NCT01083485|Primary|Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value)|"The primary efficacy variable was the 24hr pain intensity score at rest, on a Numerical Rating Scale (NRS), with 0 = no pain and 10 = worst possible pain. This was assessed 1 hour after dosing on Day 1 (evening only), Day 2(morning and evening) and Day 3 (morning only). The primary efficacy end point (absolute change from baseline) was analysed on the per protocol (PP) data. The mean of these scores is shown as a value that is a mean change (a decrease in pain score) from the baseline value."|Mean of 24 hour pain intensity (absolute change from baseline)|The primary efficacy end point (absolute change from baseline) was analysed on the PP data using a mixed model repeated measures of analysis of covariance (RMANCOVA).|||Units on a scale||95% Confidence Interval|Mean
1421621|NCT01083472|Primary|Hernia Occurrence|Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.|Month 12 after repair|Due to early termination of the study and the low enrollment number (only 37 subjects out of the planned 200 subjects being enrolled), all planned analyses of study endpoints were not performed. The only study results obtained focused on safety. Due to the small sample size these safety results should be interpreted with caution.||||||
1421622|NCT01083316|Secondary|Number of Participants Surviving at 5 Years||5 years||2018-12-31|12/2018||||
1421623|NCT01083316|Primary|Number of Participants Proceeding to Transplant Following Induction||2 months||||Participants|||Count of Participants
1421624|NCT01083316|Primary|Number of Participants Surviving at 100 Days Post Transplant||100 days||||Participants|||Count of Participants
1421625|NCT01083316|Primary|Number of Participants With Disease Response|Complete response: Normal serum free light chain ratio and Negative serum and urine immunofixation electrophoresis Very good partial response: Difference in serum free light chains less than 40 mg/L Partial Response: >50% Reduction in the difference in serum free light chains|One year||||Participants|||Count of Participants
1421626|NCT01083199|Secondary|Bladder Neck Contracture (BNC) Rate||Subjects that develop BNC between the scheduled follow-up visits at 6 weeks, 6 and 12 months post-device removal|||||||
1421627|NCT01083199|Secondary|Incontinence Rate and I-QOL Score||Baseline, 6-week, 6 and 12-month evaluations|||||||
1421628|NCT01083199|Secondary|Percentage of Subjects Demonstrating Functionally Adequate Anastomosis at the 1st and 2nd Device Removal Visits||7 and 14 days post-Device placement|||||||
1421629|NCT01083199|Secondary|Intraoperative/Postoperative Parameters||At Device placement|||||||
1421630|NCT01083199|Primary|Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-procedure in Subjects With Successful Device Placement|"Device removal was first attempted at the 7-day window; if extravasation was noted, the subject returned for a second attempt at the 14-day window. If extravasation was noted at the first and second attempts, the subject could then return for a 3rd and final removal at the 21-day window.~The following defines the timeframe of each removal attempt:~7-day window (7-10 days post-implant)~14-day window (13-15 days post-implant)~21-day window (19-21 days post-implant)"|7-21 days post-Device placement||||participants with device removal by 21d|||Number
1421631|NCT01083199|Primary|Successful Device Placement|Successful Device placement was defined as the establishment of a water-tight anastomosis immediately post-Device placement.|During Radical Prostatectomy||||participants|||Number
1421632|NCT01083186|Secondary|Homocysteine Values Throughout the Study|The homocysteine normal range 3.5-20 μmol/L.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=the number of participants with evaluable data at given time-points.|||μmol/L||Standard Deviation|Mean
1421633|NCT01083186|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12|The CRP normal range was 0-0.6 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
1421634|NCT01083186|Secondary|Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12|The HDL-C normal range was 35-90 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
1421635|NCT01083186|Secondary|Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12|The LDL-C normal range was 0-150 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
1421636|NCT01083186|Secondary|Change From Enrollment in Triglyceride Levels at Months 6 and 12|The normal range for triglycerides was 0-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
1421637|NCT01083186|Secondary|Change From Enrollment in Total Cholesterol Levels at Months 6 and 12|The total cholesterol normal range was 130-200 mg/dL.|Enrollment, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
1421638|NCT01083186|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12|The alkaline phosphatase normal range was 40-129 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||IU/L||Standard Deviation|Mean
1421639|NCT01083186|Secondary|Change From Baseline in Urea Levels at Months 6 and 12|The urea normal range was 10-50 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
1421640|NCT01083186|Secondary|Change From Baseline in Creatinine Levels at Months 6 and 12|The creatinine normal range was 0.6-1.4 mg/dL.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mg/dL||Standard Deviation|Mean
1421641|NCT01083186|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12|The aspartate aminotransferase normal range was 11-38 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||IU/L||Standard Deviation|Mean
1421642|NCT01083186|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12|The alanine aminotransferase normal range was 11-43 IU/L.|Baseline, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||IU/L||Standard Deviation|Mean
1421643|NCT01083186|Secondary|Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study|The eGFR normal range was 90-120 mL/min/1.73m^2.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||mL/min/1.73m^2||Standard Deviation|Mean
1421644|NCT01083186|Secondary|Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study|Change in CKD stage throughout the study period was assessed by the estimated glomerular filtration rate (eGFR) levels recorded by the physicians at each study time point. Classification of eGFR into CKD stages as follows: CKD stage 2: 60-89 mL/min/1.73m^2; CKD stage 3: 30-59 mL/min/1.73m^2; CKD stage 4: 15-29 mL/min/1.73m^2; CKD stage 5: <15 mL/min/1.73/m^2. Table presents the number of participants by stage at each study visit.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||participants|||Number
1421645|NCT01083186|Secondary|Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs)|In order to establish the safety profile of oral paricalcitol in daily clinical practice, non-serious adverse events (nSAEs) and serious adverse events (SAEs) were collected during the course of the study. An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.|From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.|All participants|||participants|||Number
1421646|NCT01083186|Secondary|Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study|The HbA1c normal range was 4.3-6.1%.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-points.|||percent||Standard Deviation|Mean
1421647|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 12|The values “-, Trace, +, ++, and +++” are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.|Baseline, Month 12|Number of participants with evaluable data at both Baseline and Visit 5 (12 Months Post-Enrollment)|||participants|||Number
1421648|NCT01083186|Secondary|Change in Dipstick Albuminuria Grade From Baseline to Month 6|The values “-, Trace, +, ++, and +++” are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.|Baseline, Month 6|Number of participants with evaluable data at both Baseline and Visit 3 (6 Months Post-Enrollment)|||participants|||Number
1421649|NCT01083186|Secondary|Number of Participants With Serum Phosphorus Level Abnormalities|Normal serum phosphorus range was 2.7-4.6 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point|||participants|||Number
1421650|NCT01083186|Secondary|Number of Participants With Serum Calcium Level Abnormalities|Normal serum calcium range was 8.4-10.2 mg/dL.|Baseline, Enrollment Visit, Month 6, Month 12|All participants. n=number of participants with evaluable data at given time-point.|||participants|||Number
1421651|NCT01083186|Secondary|Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range|Number of participants with iPTH levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines at each study measurement after oral paricalcitol treatment onset. K/DOQI treatment guidelines: CKD Stage 3: 35–70 pg/mL; CKD Stage 4: 70–110 pg/mL during a 12-month period of treatment with oral paricalcitol.|Enrollment Visit, Month 3, Month 6, Month 9, Month 12|All participants. n=participants with evaluable data at given time point.|||participants|||Number
1421652|NCT01083186|Secondary|Mean Duration of Effect Sustainability (Months)|The effect was considered sustainable if: the participant’s intact parathormone (iPTH) value remained equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL); or iPTH levels continued to decrease 30% from the previous available measurement.|Measured from start of study, up to a maximum of 12 months|All evaluable participants|||months||Standard Deviation|Mean
1421939|NCT01080794|Secondary|Apathy Evaluation Scale (AES)|To evaluate apathy in Parkinson's Disease. The AES mean scores were reported for each group at each time point. The AES Score Range is 0-42, where higher the score indicates greater severity of the apathy symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421653|NCT01083186|Secondary|Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels|The time to attain the first lower iPTH levels was considered as the time from the date of oral paricalcitol treatment onset until the date when any of the following conditions were initially met: a 30% reduction from iPTH levels prior to treatment onset had been achieved, for patients who were still outside the target range; or iPTH levels equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL; CKD Stage 5: ≤ 300 pg/mL).|Measured from start of study, up to a maximum of 12 months|Subset of participants with baseline CKD stage ≥ 3 as well as with available iPTH values greater than the upper limit of the target range, prior to paricalcitol treatment onset. Target range for this specific analysis was defined based on patient’s CKD stage (per baseline eGFR) prior to paricalcitol treatment onset.|||months||95% Confidence Interval|Median
1421654|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Participants with renal transplantation history. n=number of participants with available data at given time-point.|||pg/mL||Standard Deviation|Mean
1421655|NCT01083186|Primary|Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population|iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.|Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12|Overall study population. n=number of participants with available data at given time-point.|||pg/mL||Standard Deviation|Mean
1421656|NCT01083173|Primary|Percentage of Participants With Viral Load Below 50 Copies/mL|Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 48|Participants with available data|||percentage of participants|||Number
1421657|NCT01083173|Secondary|Mean Time to Treatment Failure|Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48.|From baseline through weeks 24 and 48|Participants with available data|||days||Standard Error|Mean
1421658|NCT01083173|Secondary|Percentage of Participants With Confirmed Viral Resistance|Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.|From baseline through weeks 24 and 48|Participants with available data|||percentage of participants|||Number
1421659|NCT01083173|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts|Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.|From baseline to Weeks 24 and 48|Participants with available data|||cells/mm˄3||Standard Deviation|Mean
1421660|NCT01083173|Secondary|Change From Baseline in Viral Load|This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.|Week 24 & 48|||||||
1421661|NCT01083173|Primary|Percentage of Participants With Viral Load Below 400 Copies/mL|Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.|Week 24|Participants with available data|||percentage of participants|||Number
1421662|NCT01083173|Primary|Number of Participants Who Interrupted or Discontinued Kaletra Treatment|At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).|Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment|Participants with available data|||participants|||Number
1421663|NCT01083173|Primary|Number of Participants With Adverse Events|Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.|From the start of treatment until 30 days after the last dose, up to 52 weeks|Participants with available data|||participants|||Number
1421664|NCT01083160|Secondary|Evaluate the Compliance and Clinical Tolerability With Adalimumab|To assess compliance, participants were asked at the Week 8 and Week 16 visits how many doses they had missed since their previous visit. Adverse events were collected throughout the study, from the time the participant signed the informed consent form until 30 days or 5 half-lives after the last dose of study drug. For additional information see the Reported Adverse Event section.|Baseline to Week 24|Analysis population included all participants enrolled in the study who took at least one dose of adalimumab.|||Participants|||Number
1421665|NCT01083160|Primary|Severity of Pain in a 100mm Visual Analogue Scale (VAS 100mm)|Participants assessed the severity of their pain using a 0 to 100 mm horizontal visual analogue scale (VAS). The far left end indicated no pain (0 mm) and the far right meant the worst possible pain (100 mm). Participants drew a vertical line on the horizontal scale to indicate their current level of pain at each visit.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.|||Units on a scale||Standard Deviation|Mean
1421666|NCT01083160|Primary|Tender Joint Count and Swollen Joint Count|The treating physician was to clinically assess each participant at each study visit and report the number of tender and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented.|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.|||Joints||Standard Deviation|Mean
1421690|NCT01082640|Secondary|Mean Clearance (CL/F) of Febuxostat at Steady State|Mean CL/F at steady state were estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.|||liters/hour||Standard Deviation|Mean
1421667|NCT01083160|Primary|DAS28 (Disease Activity Score in 28 Joints)|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to each visit is presented."|Baseline and Weeks 8,16 and 24|Analysis conducted in participants with results at each time point.|||units on a scale||Standard Deviation|Mean
1421668|NCT01083121|Secondary|Physician's Global Assessment for Effectiveness|The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.|After 3-month treatment|Effectiveness evaluation was performed in 1,471 participants who received adalimumab for at least 3 months and in whom investigator's assessment at 3 months was available. No participants were available in the Psoriasis group for effectiveness evaluation.|||participants|||Number
1421669|NCT01083121|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.|From Baseline until up to 70 days after the 3 month study period (total of 160 days).|Safety analysis population|||participants|||Number
1421670|NCT01082965|Secondary|Change From Baseline in CogState Test Battery at Hour 5 on Day 1 and at Hour 0, 5 on Day 8|Computerized test battery used to assess detection and identification task. CogState detection task: a measure of simple reaction time, provided valid assessment of psychomotor function. Participants were required to press a “YES” response key as soon as they detected an event (a card turning face up presented in center of the computer screen). The software measured the response time to detect each event. CogState identification task: measure of choice reaction time, provided a valid assessment of visual attention. Participants were required to decide “YES” or “NO” as to whether the event met a predefined and unchanging criterion (is the color of the card red?) while the event (a card turning face up) occurred in the center of the computer screen. The software measured the speed and accuracy of each response.|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specific time points for each arm group, respectively.|||log10 milliseconds||Standard Deviation|Mean
1421671|NCT01082965|Secondary|Change From Baseline in Rey Auditory Verbal Learning Test (RAVLT): Immediate and Delayed Recall at Hour 5 on Day 8|RAVLT, in immediate recall (IR) list of 15 words (list A) was read aloud to participant 5 times followed by a test of spontaneous retrieval (A1 to A5). After fifth attempt a list of interference, comprising 15 words (list B) was read to participant followed by its retrieval (B1). After attempt B1 examiner asked individual to recall words from list A, without reading it again (A6). Score range: 0-105, higher scores=less impairment. Delayed recall (DR):after a 20-minute interval examiner asked individual to remember words from list A without reading this list; in recognition performance a list comprising 15 words from list A, 15 words from list B, 20 distracting words (similar to words in list A, B) was read to individual. Upon each word read aloud, individual asked to indicate if it belonged to list A, or not. Score range: 0-30, higher scores=less impairment.|Baseline, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1421672|NCT01082965|Secondary|Change From Baseline in CogState Continuous Paired Associate Learning (CPAL) at Hour 5 on Day 1 and at Hour 1, 5 on Day 8|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. After 4 pictures were placed correctly, second round started. In second round pictures remain in the same locations, but their order of presentation in the center of the screen was different to that of the first round (randomized). The same process was repeated for round 3 and round 4. The outcome was the number of errors made in correctly placing each of the 4 patterns in their location 4 times.|Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants who were evaluable at specified time points for each arm group, respectively.|||errors||Standard Deviation|Mean
1421673|NCT01082965|Secondary|Change From Baseline in Arterial Spin Label (ASL) Perfusion at Hour 4 on Day 1 and at Hour 0, 4 on Day 8|Perfusion in anterior cingulate cortex, medial prefrontal cortex, precuneus, inferior parietal cortex and other regions of interest (whole brain gray, superior, medial and inferior temporal cortex; inferior and superior prefrontal cortex; insula, amygdala, thalamus, basal ganglia, hippocampus, Landau) was measured by ASL technique. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for relative perfusion rate. Relative perfusion rate is defined as the absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1, 1 minute post-dose (Hour 0), 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1421674|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1421675|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 0 on Day 8|Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 1 minute post-dose (Hour 0) on Day 8|FAS included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1421676|NCT01082965|Primary|Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 1|Posterior cingulate cortex perfusion was measured by arterial spin labeling (ASL). ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.|Baseline, 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study drug (donepezil or placebo). Here, 'N' (Number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1421677|NCT01082952|Secondary|Fold Increase in ASM Cells Proliferation Following Treatment With Cysteinyl Leukotrienes|The effect of Eosinophil release of Cysteinyl Leukotrienes on ASM proliferation was determined using blocking agents. This was determined using Ki-67 staining and flowcytometry.|one day|Eosinophils were collected from all the participants and used to trigger ASM proliferation.|||Fold increase in ASM proliferation||Standard Deviation|Mean
1421678|NCT01082952|Primary|Fold Increase in ASM Proliferation Following Incubation With Eosinophils.|Airway Smooth Muscle (ASM) cell proliferation was measured 24 hrs following their co-culture with eosinophil. This was determined using Ki-67 staining and flowcytometry. The fold increase in ASM proliferation was then determined.|one day|The number of participants for each group was determined to insure proper statistical significance when analysing the effect of isolated eosinophils on ASM cells proliferation|||Fold increase in ASM cell proliferation||Standard Deviation|Mean
1421679|NCT01082939|Primary|Number of Participants With an Overall Response|Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is > 50% decrease of clinical symptoms from baseline and recovery from blood counts.|6 cycles of treatment (28 days per cycle)||||Participants|||Number
1421680|NCT01082874|Secondary|Individual Secondary Outcomes at 1 Year|All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.|1 year|||||||
1421681|NCT01082874|Secondary|Composite Outcome at 1 Year|All-cause mortality, nonfatal MI, and nonfatal stroke.|1 year|||||||
1421682|NCT01082874|Secondary|Safety Outcomes in Clonidine Trial|Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.|30 days|||||||
1421683|NCT01082874|Secondary|Safety Outcomes in ASA Trial|Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.|30 days|||||||
1421684|NCT01082874|Secondary|Composite Outcome by ASA Stratum|Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.|30 days|||||||
1421685|NCT01082874|Secondary|Individual Secondary Outcomes|All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.|30 days|||||||
1421686|NCT01082874|Secondary|Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke||30 days|||||||
1421687|NCT01082874|Primary|All-cause Mortality and Nonfatal MI||1 year|||||||
1421688|NCT01082874|Primary|Composite of All-cause Mortality and Nonfatal MI||30 days||||participants|||Number
1421689|NCT01082640|Secondary|Mean Area Under the Concentration-Time Curve During the Dosing Interval (AUC[0-τ]) of Febuxostat at Steady State|Mean AUC during the dosing interval at steady state was estimated using a population pharmacokinetic (PK) approach, based on 2 PK samples collected prior to dosing, and 4 PK samples collected postdose.|The 2 pre-dose PK samples collected were collected at any 2 of the following visits: Months 3, 6, 9, and/or 12, at -0.25 to 0 hours. The 4 postdose PK samples were collected at Months 3, 6, and/or 9, at 0.25; 0.75 to 2.0; 2.5 to 4.0; and 5 to 12 hours.|Participants who received febuxostat and had available data for PK analysis.|||hr*µg/mL||Standard Deviation|Mean
1421731|NCT01082380|Primary|Plasma Decay Half Life (t1/2)|Plasma Decay half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||hr||Standard Deviation|Mean
1421691|NCT01082640|Secondary|Percentage of Participants With Serum Urate (sUA) Less Than 6 mg/dL at Month 12|Serum urate concentrations were determined using the enzymatic method as performed by the Central Laboratory.|Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. A patient was included in the analysis only when there was at least 1 value during the double-blind treatment period. Missing data were imputed as carrying forward the last observed post-baseline value.|||percentage of participants|||Number
1421692|NCT01082640|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Change from baseline to Month 12 in estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula (as calculated by the central laboratory).|Baseline and Month 12|Full analysis set with available data at Baseline. and at least 1 post-baseline value. Missing data was imputed as carrying forward the last post-baseline value.|||mL/min/1.73m²||Standard Error|Least Squares Mean
1421693|NCT01082640|Primary|Change From Baseline to Month 12 in Serum Creatinine|Renal function was assessed by measuring the change from Baseline in serum creatinine. Analyses were conducted by the Central Laboratory.|Baseline and Month 12|Full analysis set, including all patients who were randomized and received at least 1 dose of double-blind study medication. Only patients with both a baseline value and at least 1 value during the double-blind treatment period are included in the analysis. Missing data were imputed as carrying forward the last observed post-baseline value.|||mg/dL||Standard Error|Least Squares Mean
1421694|NCT01082614|Secondary|Quality of Recovery Score on Postoperative Day 4|Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery following surgery.|Postoperative day 4||||units on a scale||Inter-Quartile Range|Median
1421695|NCT01082614|Secondary|Quality of Recovery Score on Postoperative Day 2|Measure of quality of recovery (QOR) using scoring system in 9 domains as assessed by patient and nursing team. Score for each domain is assigned as 0, 1 or 2; the sum of scores is the QOR score with a range of 0 to 18. Higher scores indicate better quality of recovery after surgery.|Postoperative day 2||||units on a scale||Inter-Quartile Range|Median
1421696|NCT01082614|Primary|Length of Postoperative Hospital Stay|time in days from end of surgery to hospital discharge|within one month||||Days||Full Range|Mean
1421697|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
1421698|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
1421699|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12|This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
1421700|NCT01082588|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12|The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers.|Baseline, week 12||||Scores on a scale||Standard Deviation|Mean
1421701|NCT01082588|Primary|Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12|"The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.~The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, week 12|One participant from the placebo group refused to complete the MATRICS assessment at week 12; therefore, we could only analyze 24 placebo participants for the final analysis.|||Scores on a scale||Standard Deviation|Mean
1421702|NCT01082588|Primary|Change in C-Reactive Protein (CRP) From Baseline to Week 12||Baseline, week 12||||mg/L||Standard Deviation|Mean
1421703|NCT01082588|Primary|Change in LDL-cholesterol Between Baseline and Week 12||Baseline, week 12|One participant from the pravastatin group and two from the placebo group had triglyceride levels above 400. Per Massachusetts General Hospital Laboratories policy, LDL is not run as a part of the complete metabolic panel (CMP) when triglycerides are above 400, and therefore could not be included in the final analysis.|||mg/dl||Standard Deviation|Mean
1421704|NCT01082575|Primary|Number of General Care Floor Patients Exhibiting a Saturation Pattern Detection (SPD) Alert.|Number of patients on the General care Floor in which a SPD (Saturation Pattern Detection) Alert occurs. Each patient wore a sensor on their finger continuously after surgery for up to 5 days. The sensor was attached to a Nellcor N600X oximeter which measures blood oxygen level. A SPD alert detects a patient's blood oxygen level that is increasing and decreasing in a pattern that is associated with periods of no breathing.|5 days|93 evaluable patients out of 100 enrolled.|||participants|||Number
1421705|NCT01082575|Secondary|Number of Participants With Adverse Events (AE) Caused by no Breathing|Number of participants with Airway Obstruction that caused the patient to stop breathing Number of participants with Cardiac arrest w/resuscitation caused by the patient not breathing|Five Nights|All enrolled patients|||participants|||Number
1421774|NCT01081951|Secondary|Overall Survival (OS)|OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.|Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)|FAS|||Participants (Number of deaths)|||Number
1421706|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Urine|In urine, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percentage of radioactive dose|||Number
1421707|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Feces|In feces, metabolite abundance (profiling) was calculated by multiplying the fractional contribution of radioactive response for the peak in the Radio-HPLC chromatogram to the total radioactivity detected by the percent of administered dose recovered in the matrix. Only those metabolites that were a component of a chromatographic peak that accounted for an average of >=1% of the administered dose, were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percentage of radioactive dose|||Number
1421708|NCT01082380|Primary|Identification and Profiling of Metabolites of [14C]PF-02341066 in Plasma|Identification was done by Radio-High Performance liquid chromatography (HPLC) chromatogram. Relative abundance (profiling) of metabolites in chromatogram were determined by dividing sum of radioactive content of fractions contributing to particular peak by sum of radioactive content of all fractions constructing the radio chromatogram. Metabolites accounting for an average of greater than or equal to (>=) 10% of total recoverable radioactivity in plasma were summarized. Radioactivity corresponds to 100 μCi [14C] PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percentage of recovered radioactivity|||Number
1421709|NCT01082380|Primary|Overall Cumulative Percent Recovery of Radioactivity|Overall cumulative percent of radioactive dose recovered in urine, feces and toilet tissue at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Pre-dose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose for urine and Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose for feces|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||Percent recovery of radioactivity||Standard Deviation|Mean
1421710|NCT01082380|Primary|Total [14C] Data in Feces|Cumulative amount excreted in feces at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|From Day 0 through pre-dose (Day1) and as passed through until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq||Standard Deviation|Mean
1421711|NCT01082380|Primary|Total [14C] Data in Urine|Cumulative amount excreted in urine at specified intervals after administration of a single 250-mg (100 μCi) oral dose of [14C]PF-02341066.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq||Standard Deviation|Mean
1421712|NCT01082380|Primary|Apparent Volume of Distribution of Radioactivity in Whole Blood (V/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L||Standard Deviation|Geometric Mean
1421713|NCT01082380|Primary|Apparent Oral Clearance of Radioactivity From Whole Blood (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L/hr||Standard Deviation|Geometric Mean
1421714|NCT01082380|Primary|Decay Half-life (t1/2) of Radioactivity in Whole Blood|Decay half life (t1/2) is the time measured for the concentration to decrease by one half in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||hr||Standard Deviation|Mean
1421715|NCT01082380|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Radioactivity in Whole Blood|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
1421716|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Radioactivity in Whole Blood|Area under the concentration time-curve from zero to the last measured concentration (AUClast) in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
1434154|NCT00979550|Primary|Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation)|Lesions will be digitally photographed and its surface area measured by blinded observers using image analysis software|3 months|||||||
1421717|NCT01082380|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in Whole Blood|Time to Reach Maximum Observed Concentration (Tmax) of Radioactivity in whole blood. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||hr||Full Range|Median
1421718|NCT01082380|Primary|Maximum Observed Concentration of Radioactivity in Whole Blood (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq/mL||Standard Deviation|Geometric Mean
1421719|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma Radioactivity|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L||Standard Deviation|Geometric Mean
1421720|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma Radioactivity|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||L/hr||Standard Deviation|Geometric Mean
1421721|NCT01082380|Primary|Decay Half Life (t1/2) of Radioactivity in Plasma|Plasma decay half-life is the time measured for the plasma radioactivity concentration to decrease by one half. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||hr||Standard Deviation|Mean
1421722|NCT01082380|Primary|Area Under the Plasma Radioactivity Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|Area under the concentration curve from time zero to extrapolated infinite time [AUC (0 - ∞)] in plasma. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|Data was insufficient to analyze as only 2 participants were evaluable for the parameter.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
1421723|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Radioactivity Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration. Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||ng-eq*hr/mL||Standard Deviation|Geometric Mean
1421724|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Radioactivity Concentration (Tmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||hr||Full Range|Median
1421725|NCT01082380|Primary|Maximum Observed Concentration in Plasma Radioactivity (Cmax)|Radioactivity corresponds to 100 μCi [14C]PF-02341066.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The radioactivity parameter analysis population included all treated participants who had at least 1 of the radioactivity parameters of primary interest.|||nanogram-equivalent/milliliter(ng-eq/mL)||Standard Deviation|Geometric Mean
1421726|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine Expressed as Percent of Dose From Time Zero to Infinite Time [Ae(%)]||Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||Percent dose of unchanged drug||Standard Deviation|Geometric Mean
1421727|NCT01082380|Primary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to Infinite Time (Ae)|Ae = concentration of unchanged drug excreted in the urine multiplied by volume of unchanged drug excreted in urine.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||mg||Standard Deviation|Geometric Mean
1421728|NCT01082380|Primary|Renal Clearance (CLr) of PF-02341066|CLr is the volume of plasma from which a substance is completely removed by the kidney in a given amount of time.|Predose, 0 to 4, 4 to 8, 8 to 16, 16 to 24 to 36, 36 to 48 hrs and then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||L/hr||Standard Deviation|Geometric Mean
1421729|NCT01082380|Primary|Apparent Volume of Distribution (V/F) in Plasma|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||L||Standard Deviation|Geometric Mean
1421730|NCT01082380|Primary|Apparent Oral Clearance (CL/F) of Plasma PF-02341066|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||L/hr||Standard Deviation|Geometric Mean
1421732|NCT01082380|Primary|Area Under the Plasma Concentration Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Standard Deviation|Geometric Mean
1421733|NCT01082380|Primary|Area Under the Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast)|Area under the concentration time-curve from zero to the last measured plasma concentration (AUClast).|Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Standard Deviation|Geometric Mean
1421734|NCT01082380|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hrs, 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||hr||Full Range|Median
1421735|NCT01082380|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (hrs), 36 hrs, 48 hrs, then after every 24 hrs until up to 480 hrs post-dose|The Pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Standard Deviation|Geometric Mean
1421736|NCT01082367|Secondary|Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period|Sputum/throat swab cultures were assessed.|Day 91|Participants from the ITT population, who were tested for microbiology, were included in the analysis.|||Percentage of participants|||Number
1421737|NCT01082367|Secondary|Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 91|Cross-over participants from the ITT population were analyzed.|||Percentage of participants|||Number
1421738|NCT01082367|Primary|Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle|Sputum/throat swab cultures were assessed.|Day 29|Intent-to-treat (ITT): The ITT included all randomized participants who received at least dose of study treatment.|||Percentage of participants|||Number
1421739|NCT01082328|Secondary|Mean Change From Baseline in Blood Phenylalanine-to-tyrosine Ratio|Phenylalanine-to-tyrosine ratio is the best indicator of dopamine availability in PKU. The change in blood phenylalanine-to-tyrosine ratio at Day 28 was calculated as blood phenylalanine-to-tyrosine ratio at Day 28 minus blood phenylalanine-to-tyrosine ratio at Baseline.|Baseline, Day 28|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.|||Ratio||Standard Deviation|Mean
1421740|NCT01082328|Secondary|Percentage of Early-, Late- and Partial-Responders According to Phenotype|The PKU is categorized as per phenotype into classical PKU: (blood Phe levels > 1200 mcmol/l), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild HPA (blood Phe levels 300 to 600 mcmol/l). Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Percentage of participants|||Number
1421741|NCT01082328|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 30 Percent, 20 to 30 Percent, 10 to 20 Percent and Less Than (<) 10 Percent Reduction in Blood Phe Levels According to Phenylketonuria (PKU) Phenotypes|The Phenylketonuria (PKU) is categorized as per phenotype into classical PKU: (blood Phe levels greater than [>] 1200 micromole per liter [mcmol/l]), mild PKU (blood Phe levels 600 to 1200 mcmol/l), mild Hyperphenylalaninaemia (HPA) (blood Phe levels 300 to 600 mcmol/l).|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies number of participants who were evaluable for specified categories at different time points.|||Percentage of participants|||Number
1421742|NCT01082328|Secondary|Percentage of Early-, Late-, Partial-Responders and Non-responders to Treatment With Kuvan®|Early responders defined as percentage of participants with at least 30 percent reduction in Phe levels within the first seven days of treatment. Late responders defined as percentage of participants with less than 30 percent reduction in Phe levels within first seven days of treatment, but at least 30 percent reduction in Phe levels within 28 +/- 1 days of treatment. Partial responders defined as percentage of participants with Phe levels reduction between 10 and 30 percent at any blood measurement within the 28 +/- 1 days of treatment. Non-responders defined as percentage of participants with a Phe level reduction of less than 10 percent within 28 +/- 1 days.|Baseline up to Day 28 +/- 1|FAS population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.|||Percentage of participants||95% Confidence Interval|Number
1421743|NCT01082328|Secondary|Number of Participants With Adverse Events (AEs), Treatment Emergent Adverse Events, Treatment Related Adverse Events and AEs Leading to Withdrawal|An Adverse Event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Day 42 +/- 3|Safety population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.|||Participants|||Number
1434155|NCT00979459|Secondary|Number of Participants Who Discontinued Study Medication Due to an Adverse Event||up to 8 days|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.|||participants|||Number
1421744|NCT01082328|Primary|Percentage of Participants With at Least 30 Percent Reduction From Baseline in Blood Phenylalanine (Phe) Level|Response to treatment was defined as 30 percent reduction from Baseline in blood phenylalanine (Phe) Level during the 28 +/- 1 days.|Baseline up to Day 28 +/- 1|Full analysis set (FAS) population included all the participants with a valid Baseline blood Phe level measure and who received at least one dose of Kuvan®.|||Percentage of participants||95% Confidence Interval|Number
1421745|NCT01082211|Secondary|Treatment-related Adverse Events Occurring After One Year From Completion of Re-irradiation|AEs were graded with CTCAE version 4. The overall highest grade for each patient is computed from reported adverse events definitely, probably, or possibly related to protocol treatment occurring after one year from completion of re-irradiation.|After 1 year from the end of radiation.|All eligible patients|||percentage of participants|||Number
1421746|NCT01082211|Secondary|Overall Survival|Failure is death due to any cause. Three-year overall survival rate was estimated using the Kaplan-Meier method.|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1421747|NCT01082211|Secondary|Mastectomy-free Survival|Failure is mastectomy of the treated breast or death due to any cause. Mastectomy-free survival rate at three years was estimated using the Kaplan-Meier method.|From registration to date of mastectomy, death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1421748|NCT01082211|Secondary|Distant Metastasis-free Survival|Failures are appearance of ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrences; distant metastases confirmed radiographically and/or pathologically; or death due to any cause. Note that a distant metastases was only considered a treatment failure if accompanied by an in-breast recurrence.|From registration to date of distant metastasis, death or last follow-up. Analysis occurs after all patient have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1421749|NCT01082211|Secondary|Cosmesis||After surgery prior to the start of radiation, 1 year from the end of radiation and 3 years from the end of radiation. Analysis occurs after all patients have been potentially followed for 3 years.||2018-11-30|11/2018||||
1421750|NCT01082211|Secondary|Treatment-related Adverse Events (AEs) Any Time|AEs were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. The overall highest grade for each patient was computed from all reported adverse events definitely, probably, or possibly related to protocol treatment.|From the end of radiation to end of follow-up. Will be evaluated at the time of the primary analysis.|All eligible patients|||percentage of participants|||Number
1421751|NCT01082211|Secondary|Number of Patients With Detectable/Undetectable/Unevaluable Circulating Tumor Cells (CTCs)|"CTCs in peripheral blood were assessed using the CellSearch (trademark) system. A stringent algorithm was used to classify cell images as a CTC. A CTC must express EpCAM [epithelial cell adhesion molecule] and not leukocyte lineage-specific antigens, exhibit cytoplasmic expression of cytokeratin, and contain a nucleus that binds DAPI [4',6-doamidino-2-phenylindole]. A cell image is not a CTC if any of the previous criterion are missing. A subject is categorized as Detectable if the patient had a CTC and Undetectable if the subject had no CTCs. If neither category could be determined, then the subject was categorized as Unevaluable."|Prior to the start of radiation and 3 weeks after last radiation treatment.|Eligible patients who consented to participate in the CTC portion of the trial|||Participants|||Count of Participants
1421752|NCT01082211|Secondary|Freedom From Mastectomy|Failure is mastectomy of the treated breast. Mastectomy rate at 3 years is reported, using the cumulative incidence with death as competing risk. Mastectomy-free survival is reported in outcome measure 10.|From registration to date of mastectomy or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1421753|NCT01082211|Secondary|In-breast Recurrence|The definition of treatment failure is histologic evidence of recurrent carcinoma, either invasive or non-invasive (except LCIS) in the ipsilateral breast. Clinical evidence of carcinoma by physical examination and/or mammograms and/or MRI will not be construed as evidence of treatment failure without biopsy proof but will be considered as suspicious for recurrence. Ipsilateral breast recurrences will be considered local (infield) if they occur within the prescription isodose volume; they will be considered peripheral if they occur between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume. Ipsilateral recurrences will be considered non-contiguous or extra field if they are beyond the peripheral volume described above.|From registration to date of recurrence or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.|All eligible patients.|||percentage of participants||95% Confidence Interval|Number
1421754|NCT01082211|Primary|Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events|Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible & started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable.|From the end of radiation to 1 year.|The first 55 eligible patients who completed treatment and achieved 1 year of follow-up.|||participants|||Number
1421934|NCT01080794|Secondary|Global Impression Scales|To assess symptom severity and treatment response in Parkinson's Disease. The CGI mean scores were reported for each group at each time point. The CGI Score Range is 1 - 8, where higher the score indicates greater severity of illness or worsening of illness.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421755|NCT01082159|Primary|Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).|The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Month 6|All participants at month 6 who completed all questionnaire fields necessary to analyze PCS data according to guidelines.|||units on a scale||95% Confidence Interval|Mean
1421756|NCT01082159|Primary|Function as Measured Subjectively by the Oswestry Disability Index Questionnaire|Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Month 6|All available patients at 6 months are reported below.|||units on a scale||95% Confidence Interval|Mean
1421757|NCT01082159|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|"The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant.~The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value."|Baseline and Month 6|All available participants who reported Month 6 outcomes are included in this analysis.|||units on a scale||95% Confidence Interval|Mean
1421758|NCT01082081|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421759|NCT01082081|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421760|NCT01082081|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421761|NCT01082081|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421762|NCT01082081|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421763|NCT01082081|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421764|NCT01082081|Secondary|Total Pain Relief (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421765|NCT01082081|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421766|NCT01082081|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1421767|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours|Percentage of participants who took rescue medication during 2 to 6 hours|Within 2 to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
1421768|NCT01082081|Secondary|Percentage of Participants Who Took Rescue Medication Within 2 Hours|Percentage of participants who received rescue medication within 2 hours|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
1421769|NCT01082081|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants was calculated.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.|||minutes||Full Range|Median
1421770|NCT01082081|Secondary|Time to Onset of Meaningful Pain Relief|Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
1421771|NCT01082081|Secondary|Time to Confirmed First Perceptible Pain Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
1421772|NCT01082081|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from baseline to 6 hours post dose||||Units on a scale||Standard Deviation|Mean
1421773|NCT01081951|Secondary|Percentage Change in Tumour Size|The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.|Week 9 (+/- 1 week)|FAS, but including only patients with target lesions at baseline|||Percentage change||Standard Error|Least Squares Mean
1424305|NCT01061333|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1)|Maximal percent drop in FEV1 at 20 minutes post allergen challenge|Pre-allergen challenge and 20 minutes after allergen challenge||||Percentage drop in FEV1||Standard Deviation|Least Squares Mean
1421775|NCT01081951|Primary|Progression Free Survival (PFS)|PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).|Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)|Full Analysis Set (FAS)|||months||95% Confidence Interval|Median
1421776|NCT01081912|Secondary|Mean Change of the Clinic NRS Pain Intensity|The change in pain intensity as measured in the clinic by a 0-10 Numeric Rating Scale (NRS)|Baseline to Day 85 visit|||||||
1421777|NCT01081912|Primary|Mean Change in 24-hour Pain Intensity Ratings Scale (NRS).|Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.|Baseline to Day 85 (Treatment Phase)|The primary efficacy analysis used the Intent to treat (ITT) population which included all 302 randomized subjects.|||units on a scale||Standard Deviation|Mean
1421778|NCT01081886|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1421779|NCT01081886|Primary|Post-operative Pain|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1421780|NCT01081873|Secondary|Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline|The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
1421781|NCT01081873|Secondary|Epidemiological Data: Bone Scan at Baseline|The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
1421782|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.|N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
1421783|NCT01081873|Secondary|Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test|In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
1421784|NCT01081873|Secondary|Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.|The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
1421785|NCT01081873|Secondary|Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.|The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
1421786|NCT01081873|Secondary|Epidemiological Data: PSA at Baseline|The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for PSA at baseline was available for 2,532 patients.|||ng/mL||Full Range|Median
1421787|NCT01081873|Secondary|Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy.|Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.|at time 0 (Baseline)|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.|||participants|||Number
1421788|NCT01081873|Secondary|Epidemiological Data: Race|The number of participants by race at baseline is presented.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients.|||participants|||Number
1421789|NCT01081873|Secondary|Epidemiological Data: Mean Age|The mean age of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.|||years||Standard Deviation|Mean
1421790|NCT01081873|Secondary|Epidemiological Data: Mean Weight|The mean weight of all participants at baseline is provided.|at time 0 (Baseline)|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients.|||kg||Standard Deviation|Mean
1421791|NCT01081873|Secondary|Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)|The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details.|Baseline to disease progression or 24 months, whichever came first|Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded.|||participants|||Number
1421792|NCT01081873|Primary|Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy.|Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy).|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
1421793|NCT01081873|Primary|Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months|The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and < 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator.|time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
1421794|NCT01081873|Primary|Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit|Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator.|month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
1421795|NCT01081873|Primary|Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit|The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||ng/mL||Standard Deviation|Mean
1421796|NCT01081873|Primary|Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit|The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized.|time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first|Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit.|||participants|||Number
1421797|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in HDL-C from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
1421798|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares mean percent change in triglycerides from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1421799|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mmHg||Standard Error|Least Squares Mean
1421800|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
1421801|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
1421802|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
1421803|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy)|The table below shows the percentage of patients with HbA1c <7% at Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percentage of patients|||Number
1421804|NCT01081834|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
1421805|NCT01081834|Secondary|Percent Change in Triglycerides From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
1421806|NCT01081834|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mmHg||Standard Error|Least Squares Mean
1421807|NCT01081834|Secondary|Percent Change in Body Weight From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent change||Standard Error|Least Squares Mean
1421808|NCT01081834|Secondary|Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in 2-hour post-prandial glucose from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
1421809|NCT01081834|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||mg/dL||Standard Error|Least Squares Mean
1421810|NCT01081834|Secondary|Percentage of Patients With HbA1c <7% at Week 26 (Main Study)|The table below shows the percentage of patients with HbA1c <7% at Week 26. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percentage of patients|||Number
1421811|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group in patients randomized to the High Glycemic Substudy.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent||Standard Error|Least Squares Mean
1437340|NCT00955487|Secondary|Symptomatic PDA Requiring Medical Treatment|Number of participants with a symptomatic PDA that required medical treatment|From randomization until discharge||||Participants|||Count of Participants
1421812|NCT01081834|Primary|Change in HbA1c From Baseline to Week 26 (Main Study)|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values|||Percent||Standard Error|Least Squares Mean
1421813|NCT01081795|Secondary|Short Form-36 Health Survey (SF-36) Score|The SF-36 is a survey of participant health. It consists of 8 scaled scores, which are weighted sums of the questions in their section. The 8 sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each item is scored on a 0-100 range so that total score ranges from 0-100 with high score indicating more favorable health state. Final evaluation was done at Day 155 or at discontinuation for those participants who discontinued before Day 155.|Baseline (28 days before randomization), Day 29, 85 and final evaluation (FE) (Day 155/early withdrawal [EW])|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here 'n' signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1421814|NCT01081795|Secondary|Percentage of Participants With Response to Study Treatment|Responders were the participants who had at least 50 percent reduction in the average number of monthly migraine attacks.|Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Percentage of participants|||Number
1421815|NCT01081795|Secondary|Change From Baseline in the Average Number of Rescue Drug Treatment Days at Month 6|Rescue medications are medicines that may be administered to the participants when efficacy of study drug is not satisfactory, or the effect of study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, NSAIDs, ergotamines, triptans and anti-emetics. Average at Month 6 was calculated by dividing total number of rescue drug treatment days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Month 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Error|Least Squares Mean
1421816|NCT01081795|Secondary|Average Number of Rescue Drug Treatment Days|Rescue medications are administered to participants when efficacy of study drug is not satisfactory, or effect of study drug is too great and is likely to cause a hazard to participant, or to manage an emergency situation. If an aura of migraine, a migraine attack or a non-migraine headache attack occurred during the study period, use of following rescue drugs was permitted: analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), ergotamines, triptans and anti-emetics (drug used to stop vomiting). Average at baseline was calculated by dividing total number of rescue drug treatment days until baseline by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
1421817|NCT01081795|Secondary|Change From Baseline in Migraine Attacks (According to 24-Hour Rule) Over Week 19 to Week 22 Period|The change from baseline in average number of migraine attacks (as per 24-hour rule) over Week 19 to Week 22 period was calculated by subtracting the baseline value from the average value of the Week 19 to Week 22 period.|Baseline (28 days before randomization), Week 19 to Week 22 Period|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Error|Least Squares Mean
1421818|NCT01081795|Secondary|Change From Baseline in Monthly Migraine Attacks (According to 48-Hour Rule) at Month 1, 2, 3, 4, 5 and 6|As per 48-hour rule, if the symptom of pain due to migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, the 2 migraine attacks should be considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
1421819|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attacks (According to the Diagnostic Criteria of the International Headache Society) at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attacks until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
1421935|NCT01080794|Secondary|Beck Depression Inventory (BDI-II)|To assess mood symptoms in Parkinson's Disease. The BDI-II mean scores were reported for each group at each time point. The BDI-II Score Range is 0 - 63, where higher the score indicates greater severity of the mood symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421820|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Headache Days at Month 1, 2, 3, 4, 5 and 6|Headache days were the days when at least 30-minute migraine and non-migraine headache occurred and were calculated from the headache diaries kept by the participants. Average at given month was calculated by dividing total number of headache days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
1421821|NCT01081795|Secondary|Change From Baseline in Average Number of Monthly Migraine Attack Days at Month 1, 2, 3, 4, 5 and 6|Migraine is a headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 following characteristics: unilateral location, pulsating quality, moderate/severe pain and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes); average at given month was calculated by dividing total number of migraine attack days until that month by the total number of days of assessment, multiplied by 28 (a month was equal to 28 days).|Baseline (28 days before randomization), Month 1, 2, 3, 4, 5 and 6|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
1421822|NCT01081795|Primary|Mean Change From Baseline in Monthly Migraine Attacks (According to 24-Hour Rule) Through Month 6|As per 24-hour rule, if symptom of pain due to migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If the interval between latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks should be considered as 1 migraine attack. If the onset of migraine was prevented by a rescue drug, it should be considered as 1 migraine attack even if aura had started. Mean change was calculated by subtracting baseline value from the mean of 6 months value.|Baseline (28 days before randomization) through Month 6|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
1421823|NCT01081769|Primary|Number of Participants With a Relapse Event|Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator’s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (“much worse”) or 7 (“very much worse”) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.|from baseline (Day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||number of participants|||Number
1421824|NCT01081769|Secondary|Change From Baseline in Physician’s Treatment Satisfaction|Physician’s treatment satisfaction was assessed using the physician’s treatment satisfaction scale which is designed to rate 4 aspects of treatment (efficacy, safety, mode of administration, and overall satisfaction), each on a scale ranging from 1 (extremely satisfied) to 7 (extremely dissatisfied).|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421825|NCT01081769|Secondary|Change From Baseline in Patient’s Treatment Satisfaction|Patient’s satisfaction with medication was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM is divided into 4 subscales (effectiveness, side effects, convenience, and global satisfaction), with the value of each subscale ranging from 0 to 100. Higher scores indicate greater treatment satisfaction.|baseline (day 1 of core phase), month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421826|NCT01081769|Secondary|Change From Baseline in Subjective Well-Being Under Neuroleptics-Short Form (SWN-S) Total Score|The SWN-S is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). The total score ranges from 20 to 120 with higher score indicating greater subjective well-being.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421827|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score|"The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. A higher score indicates an improvement in health in the Health Status Index."|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1425739|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||6 months|||||||
1421828|NCT01081769|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) VAS Score|The EQ-5D VAS records the respondent’s self-rated health on a vertical, visual analog scale, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual respondent.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421829|NCT01081769|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The Short Form-36 Health Survey (SF-36) is a measure of Participant-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary. Each summary scale score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.|baseline (day 1 of core phase), month 6, 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421830|NCT01081769|Secondary|Changes From Baseline in Personal and Social Performance (PSP) Total Score|The Personal and Social Performance (PSP) scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|baseline (day 1 of core phase), month 1, 3, 6, 9, 12, 15, 18, 21 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421831|NCT01081769|Secondary|Clinical Global Impression-Change (CGI-C)|The Clinical Global Impression-Change (CGI-C) rating scale is used to rate the change in severity of the patient's illness compared to baseline (day 1 of core phase) on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Month 24 and endpoint|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||percentage of participants|||Number
1421832|NCT01081769|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global clinical assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate higher impression of illness severity."|Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421833|NCT01081769|Secondary|Change From Baseline in PANSS Marder Factor Scores|Change from baseline in schizophrenia symptoms were assessed through the following PANSS factor scores as described by Marder: (1) positive symptoms (range 8-56): sum of delusions, hallucinatory behavior, grandiosity, suspiciousness, stereotyped thinking, somatic concern, unusual thought content, lack of judgment and insight; (2) negative symptoms (range 7-49): sum of blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance; (3) disorganized thoughts (range 7-49): sum of conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, poor attention, disturbance of volition, and preoccupation; (4) uncontrolled hostility/excitement (range 4-28): sum of excitement, hostility, uncooperativeness and poor impulse control; (5) anxiety/depression (range 4-28): sum of anxiety, guilt feelings, tension, and depression. Higher scores indicate higher severity of symptoms|Baseline (day 1 of core phase), day 8, month 12 and 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421834|NCT01081769|Secondary|Change From Baseline in PANSS Subscale Score|Change from baseline in positive symptom, negative symptom and general psychopathology subscales of the PANSS scale. The PANSS scale is designed to assess symptoms of schizophrenia by means of the 30-items. The PANSS scale provides subscores for 3 subscales, that is, the positive symptoms subscale (7 items, range 7-49), the negative symptoms subscale (7 items, range 7-49), and the general psychopathology subscale (16 items, range 16-112). Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). Higher scores indicate higher severity of schizophrenia symptoms.|Baseline (day 1 of core phase), day 8, month 12, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421835|NCT01081769|Secondary|Change From Baseline in PANSS Total Score|Change from baseline in the PANSS: The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||units on a scale||Standard Deviation|Mean
1421836|NCT01081769|Secondary|Percentage of Treatment Responders|The proportion of patients achieving a treatment response, defined as a ≥30% decrease (i.e., improvement) in Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint. The PANSS is a 30-item scale (Range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate increased severity of schizophrenia symptoms.|from baseline (day 1 of core phase) up to maximally 24 months|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||percentage of participants||95% Confidence Interval|Number
1421837|NCT01081769|Primary|Time to First Relapse Event|Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator’s judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 (“much worse”) or 7 (“very much worse”) on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.|from baseline (Day 1 of core phase) up to maximally 24 months.|all randomized subjects who responded at the end of the 2-week initial acute oral treatment phase, who also received at least one dose of study medication during the 24-month core treatment phase and provided at least one post-baseline efficacy assessment|||days||Standard Error|Mean
1421838|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized|The mean (average) number of days hospitalized per participant for those hospitalized during the study.|Baseline to Month 24 Visit|Based on participant hospitalizations during the study where the length of hospitalization was known (82 participants total).|||days||Standard Deviation|Mean
1421839|NCT01081665|Secondary|To Estimate the Incidence of (S)AEs/(S)ADRs|The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||participants|||Number
1421840|NCT01081665|Secondary|The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product|The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg^2/dL^2) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||Participants|||Number
1421841|NCT01081665|Secondary|The Incidence of Clinically Significant Hyperphosphatemia|The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||Participants|||Number
1421842|NCT01081665|Secondary|The Incidence of Clinically Significant Hypercalcemia|The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||Participants|||Number
1421843|NCT01081665|Secondary|The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)|Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.|Baseline to Month 24 Visit|Analysis based on the evaluable population, defined as participants with baseline and at least 2 post-baseline parathormone measurements at the 24-month post-treatment follow-up visit.|||percentage of participants|||Number
1421844|NCT01081665|Primary|Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations|The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.|Baseline to Month 24 Visit|Analysis included all enrolled participants.|||participants|||Number
1421845|NCT01081626|Secondary|Number of Participants Who Answered Ease of Use of Gonal-f® Pen Questionnaire|Ease of use of Gonal-f® pen was assessed through a questionnaire consisting of 23 questions and the number of participants who responded to the questionnaire was recorded.|On hCG administration day (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
1421846|NCT01081626|Secondary|Total Follicle Stimulating Hormone (FSH) Dose||End of stimulation cycle (less than or equal to [<=] 35 days|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||IU||Standard Deviation|Mean
1421847|NCT01081626|Secondary|Duration of Follicle Stimulating Hormone (FSH)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||Days||Standard Deviation|Mean
1421848|NCT01081626|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||participants|||Number
1421849|NCT01081626|Secondary|Number of Participants With Cancelled Cycles|Participants with cancelled cycles were those who did not achieve adequate follicular formation (at least 17 mm) for hCG administration.|End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
1421850|NCT01081626|Secondary|Number of Participants Who Received Human Chorionic Gonadotropin (hCG)||End of stimulation cycle (less than or equal to [<=] 35 days)|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
1421851|NCT01081626|Secondary|Number of Participants With Injection Tolerability|Participants who did not show any injection site reactions such as pain, redness, bruises, swelling and irritation were considered to have injection tolerability.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||participants|||Number
1421852|NCT01081626|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment. Number of participants analyzed (N) included participants who were evaluated for this particular measure.|||participants|||Number
1421853|NCT01081626|Secondary|Number of Participants With Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The safety population included all the participants who received at least 1 dose of study medication and had 1 follow-up visit.|||participants|||Number
1421854|NCT01081626|Secondary|Number of Participants With Multi-follicular Development|Multi-follicular development was defined as the development of more than 3 follicles >= 15 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post hCG administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The ITT population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||participants|||Number
1421855|NCT01081626|Primary|Percentage of Participants With a Mono-follicular Development|Mono-follicular development was defined as the development of only 1 follicle of greater than or equal to (>=) 17 millimeter (mm) diameter and no more than 2 other follicles larger than 14 mm in diameter at or before Days 35-42 of stimulation period assessed by means of a transvaginal ultrasound scan.|Day 0 (first dose) up to Days 35-42 post human chorionic gonadotropin [hCG] administration (end of stimulation cycle {less than or equal to [<=] 35 days})|The Intention-To-Treat (ITT) population included all the participants who received at least 1 dose of study medication, had 1 efficacy assessment and did not have any protocol criteria violations or did not receive a wrong treatment.|||percentage of participants|||Number
1421856|NCT01081301|Secondary|SF12: Physical Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
1421857|NCT01081301|Secondary|Non-Death Revised Grief Experience Inventory|The Non-Death Revised Grief Experience Inventory measures grief that is not associated with the death of a person. It is a 22-item scale measuring four domains (existential concerns, depression, tension and guilt, and physical distress) of the grief experience. Responses are scored on a 6-point scale, ranging from slight disagreement to strong agreement, with higher total score indicating more grief and loss. The Non-Death Revised Grief Experience Inventory has a minimum score of 22 and a maximum score of 132.|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
1421858|NCT01081301|Secondary|General Self-Efficacy Score (GSES)|The scale consists of 10 items with responses from 1-4. The higher the Scores on the General Self Efficacy Scale (which has a range from 10 - 40), indicate higher participant feelings of self-efficacy. The General Self Efficacy Scale was chosen as a measure for this study because it has been found to be a reliable and valid measure in many populations.|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
1421859|NCT01081301|Secondary|SF12 Mental Health|The SF12 was developed to be a shorter yet valid alternative to the SF 36 as a measure of quality of life. The SF12 measures 7 concepts: Physical functioning, role limitations due to physical health problems, bodily pain, general healthy vitality, social functioning, role limitations due to emotional problems and mental health. It produces a physical component summary score (PCS), and a mental health component summary score (MCS). Scores range from 0 (poor health) to 100 (perfect health).|baseline, 1 and 2 wks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
1421860|NCT01081301|Primary|Herth Hope Index|The Herth Hope Index is a 12 item (1-4 point) Likert scale that delineates three sub-scales of hope: a) temporality and future, b) positive readiness and expectancy, and c) interconnectedness. These three subscales are consistent with descriptions of hope by caregivers in the preliminary work completed by the research team. The subscales also include measures of relationships and spirituality that are considered factors that influence hope. Summative scores range from 12-48, with a higher score denoting greater hope.|Baseline, 1week, 2 weeks, 3, 6 and 12 months||||units on a scale||Standard Deviation|Mean
1421861|NCT01081249|Secondary|Subjective Ratings of Anxiety and Trust of the Therapist|Patient will fill out ratings of subjective anxiety (STAI), mood and energy (PANAS), and trust (Likert scale) in the therapist before and after the session.|measured before drug, immediately before session, and after the session|||||||
1421862|NCT01081249|Secondary|Heart Rate Variability (HRV)|HRV will be measured before, during and after the therapy session.|continuously monitored from time before drug delivery to 20 minutes after session|||||||
1421863|NCT01081249|Secondary|Salivary Cortisol|Salivary cortisol will be measured after the treatment, and before, during and after the therapy session.|before drug, before session, and 20 minutes after session|||||||
1421864|NCT01081249|Primary|Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug|Videotapes of 2 therapy session (PBO/OT) were reviewed by blinded raters to determine differences in two treatments. There were nine aspects analyzed using the Ethological Coding System for Interviews: eye contact, affiliation, submission, prosocial, flight, assertion, displacement, relaxation, and gesture.|videotapes of session were reviewed and scored 1-3 months after the patient completes the study||||Number of behaviors exhibited||Standard Deviation|Mean
1421865|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Open-Label Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|13 weeks|Open-label Safety Population defined as all subjects who took at least 1 dose of any investigational product during the study.|||participants|||Number
1421866|NCT01081145|Secondary|HUI 2/3 Scores During the Open-Label Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|13 weeks|Open-label FAS|||units on a scale||Standard Deviation|Mean
1421867|NCT01081145|Secondary|Change From Open-Label Baseline in WFIRS-P Global Score at Week 13 of the Open-Label Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Open-label FAS|||units on a scale||Standard Deviation|Mean
1421868|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on CGI-S Scale During the Open-Label Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|13 weeks|Open-label FAS|||percentage of participants|||Number
1421869|NCT01081145|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores During Open-Label Phase - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|13 weeks|Open-label FAS|||percentage of participants|||Number
1421870|NCT01081145|Secondary|Percentage of Responders in the Open-Label Phase - LOCF|Response is defined as a percentage decrease (improvement) from Baseline in the ADHD-RS-IV total score of >=30% and a CGI-S score of 1 or 2.|13 weeks|Open-label FAS|||percentage of participants|||Number
1421871|NCT01081145|Secondary|Change From Open-Label Baseline in ADHD-RS-IV Total Score at Week 13 of the Open-Label Phase - LOCF|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 13 weeks|Open-label Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of any investigational product during the study. The Subjects from Site 801 were excluded from the Open-label FAS.|||units on a scale||Standard Deviation|Mean
1421872|NCT01081145|Secondary|Columbia-Suicide Severity Rating Scale During Double-Blind Randomized-Withdrawal Phase|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|26 weeks|Randomized Safety Population defined as all subjects who were randomized and who took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase.|||participants|||Number
1421873|NCT01081145|Secondary|Health Utilities Index-2/3 (HUI 2/3) Scores During the Double-Blind Randomized-Withdrawal Phase - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|26 weeks|Randomized FAS|||units on a scale||Standard Deviation|Mean
1421874|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 26|Randomized FAS|||units on a scale||Standard Error|Least Squares Mean
1421875|NCT01081145|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale During the Double-Blind Randomized-Withdrawal Phase - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|26 weeks|Randomized FAS|||percentage of subjects|||Number
1421876|NCT01081145|Secondary|Change From Double-Blind Randomized-Withdrawal Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 26 of the Double-Blind Randomized-Withdrawal Phase - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and week 26|Randomized FAS|||units on a scale||Standard Error|Least Squares Mean
1421877|NCT01081145|Secondary|Time to Treatment Failure During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized FAS|||Days||95% Confidence Interval|Median
1421878|NCT01081145|Primary|Percentage of Participants With Treatment Failures During the Double-Blind Randomized-Withdrawal Phase|Treatment failure was defined as >= 50% increase (worsening) in ADHD-RS-IV total score and a >= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.|26 weeks|Randomized Full Analysis Set (FAS) defined as all subjects who were randomized and took at least 1 dose of investigational product during the Double-blind Randomized-withdrawal Phase. Subjects from Site 801 were excluded from the Randomized FAS.|||percentage of treatment failures||95% Confidence Interval|Number
1421879|NCT01081132|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||participants|||Number
1421880|NCT01081132|Secondary|Structure Side-Effect Questionnaire (SSEQ)|The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking ‘yes’ or ‘no’ on the checklist for each of the events listed.|Through week 16|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||participants|||Number
1421881|NCT01081132|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment|The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
1421882|NCT01081132|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 item questionnaire scored on a scale from 0 (never) to 4 (always/very often). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline through week 13|Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421883|NCT01081132|Secondary|Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13|Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Lower scores reflect better functioning.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421884|NCT01081132|Secondary|Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|weeks 1 through 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of subjects|||Number
1421885|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421886|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421887|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1425740|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||12 months|||||||
1421888|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Social Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421889|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Risk Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421890|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Global Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421891|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421892|NCT01081132|Secondary|Change From Baseline in the WFIRS-P Family Domain Score at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421893|NCT01081132|Secondary|Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
1421894|NCT01081132|Secondary|Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment|CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)|Baseline through week 13|Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of subjects|||Number
1421895|NCT01081132|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline through week 13|The Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. A mixed model repeated measures (MMRM) was used to analyze the observed change from the Baseline Visit scores at all post-baseline, pre-taper, on-treatment visits.|||units on a scale||Standard Error|Least Squares Mean
1421896|NCT01081041|Secondary|Area Under the Concentration Curve (AUC) of Cetuximab at Steady State|A total of 4 samples were collected during combination therapy, from the first dose of 250 mg/m^2 cetuximab in Cycle 1 (Day 1) through the final dose in Cycle 3 (Week 3) and used to report AUC of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Day 1 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (250 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|||micrograms*hours/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1421897|NCT01081041|Secondary|Cmax of Cetuximab at Steady State|A total of 4 samples were collected at various times during combination therapy, from the third dose of 250 mg/m^2 cetuximab in Cycle 1 (Week 3) through the final dose in Cycle 3 (Week 3) and used to report Cmax of cetuximab at steady state during Part 2 of the study. As specified in the protocol, PK samples were not collected during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|Part 2: Weekly from Cycle 1, Week 3 through Cycle 3, Week 3: 0 h (immediately postdose), 24 h, 96 h, and 168 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m^2) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In, or during Part 2 monotherapy.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1421898|NCT01081041|Secondary|Maximum Serum Concentration (Cmax) of Cetuximab Following 400 mg/m² Cetuximab Dosing|The Cmax of cetuximab following 400 mg/m² cetuximab dosing during Part 2 of the study is reported. As specified in the protocol, pharmacokinetics (PK) samples were not collected during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy.|Part 2: Cycle 1, Day 1: 0 hours [(h); immediately postdose], 1 h, 2 h, and 24 h postdose|Participants who received at least 1 dose of cetuximab (400 mg/m²) and had valid serum cetuximab concentrations during the specified time frame. No participant was analyzed during Part 1 of the study, Safety Lead-In or during Part 2 monotherapy..|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1421936|NCT01080794|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Parts I, II, and IV|"To assess apathy, cognition, depression, activities of daily living (ADL), quality of life (QOL), and motor symptoms in Parkinson's Disease.~The UPDRS I, II, IV total mean scores were reported for each group at each time point. The UPDRS I, II, IV scores were added together for each patient, with a total score range of 0 - 91, where higher the score indicates greater severity of the symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421899|NCT01081041|Secondary|Percentage of Participants Having a Best Response of CR, PR, or Stable Disease (SD) - Disease Control Rate (DCR)|Response was defined using RECIST, v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) was defined as small changes that did not meet the above criteria.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1421900|NCT01081041|Secondary|Number of Participants With Anti-Cetuximab Antibodies||Day 1, Week 1 of Cycles 3 and 5 (postbaseline samples were collected prior to infusion).|Participants who received at least 1 dose of study drug and had evaluable data for antibodies.There was no pre-specified analysis plan for trial to report immunogenicity results separately for each arm,as results were intended to be pooled and combined with other cetuximab trials data.Data was pooled for the three arms for cetuximab in this trial.|||participants|||Number
1421901|NCT01081041|Secondary|Percentage of Participants Having a Confirmed Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version [v]1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants with a confirmed CR or PR=(number of participants whose best overall response was CR or PR)/(number of participants treated)*100.|Parts 1 and 2: Randomization to Progression of Disease (Up to 32.7 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1421902|NCT01081041|Secondary|Progression-Free Survival (PFS)|PFS was defined as duration from the date of randomization to the first date of objective progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had objective PD as of the 23 October 2014 data cutoff date for the analysis, PFS was censored at the date of the participant’s last complete tumor assessment prior to that cutoff date. In addition, any participant in Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Progression of Disease or Death from any Cause (Up to 32.7 Months)|All participants who received at least one dose of study drug. 7 participants were censored in Safety Lead-In ,12 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).|||Months||95% Confidence Interval|Median
1421903|NCT01081041|Secondary|Overall Survival (OS)|OS was defined as duration from the date of randomization to the date of death from any cause. For each participant not known to have died as of the 23 October 2014 data cutoff date for the analysis, OS was censored at the date last known to be alive. In addition, any participants on Arm B who was switched from BI-manufactured cetuximab to ImClone-manufactured cetuximab was censored at the time of the switch.|Parts 1 and 2: Randomization to Date of Death from any Cause (Up to 36.3 Months)|All participants who received at least on dose of study drug. 4 participants were censored in Safety Lead-In, 17 participants were censored in Cetuximab (US Commercial) and 15 in Cetuximab (Manufactured by BI).|||Months||95% Confidence Interval|Median
1421904|NCT01081041|Primary|Number of Participants Who Had TEAEs; Data Analysis Cut-Off: January 23, 2013|January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy or date first participant switched to US commercial cetuximab (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized.|||participants|||Number
1421905|NCT01081041|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs); Data Analysis Cut-Off: September 27, 2013|September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.|Part 2: Baseline to end of combination therapy (up to 18 weeks)|Participants who received at least 1 dose of study drug (cetuximab, cisplatin, carboplatin, or 5-FU) according to the treatment arm to which they were assigned or randomized. Data is confounded for 9 participants in BI-manufactured cetuximab treatment arm who switched to US commercial cetuximab.|||participants|||Number
1421906|NCT01080976|Primary|Search Engine Preference|Based on the results of primary outcome 1 (Website Ranking), preference for search engine was measured qualitatively between Google and Health-on-the-Net.|Immediate||||Participants|||Count of Participants
1421907|NCT01080976|Primary|Website Ranking|Primary care and diabetes clinicians' preference in a set of webpage search results on a visual analog scale (1-100) with 1 being the lowest preference and 100 being the highest. Rankings based on qualitative measures, such as perceived clinical relevance, perceived accuracy of content, and perceived timeliness of content.|Immediate|Participants were asked to rank 10 pages of website search results from Google and HoN search engines based on clinician preference. Clinicians were further asked for feedback and opinions on how they determined their ranking. Rankings of individual websites were done by visual analog scale, from 1-100, with 100 indicated as highly preferred.|||units on a scale|||Number
1421908|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Intimacy subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
1421909|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Social Outcome subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
1421910|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Vigilance subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
1421911|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score|FOSQ-10 consists of 10 questions rated on a scale of 1-4 (1=extreme difficulty, 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the General Productivity subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
1421912|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score|FOSQ-10 consists of 10 questions rated on a scale of 1 to 4 (1=extreme difficulty and 4=no difficulty), and is used to measure the impact of daytime sleepiness on activities of daily living and quality of life. A total score and 5 subscale (vigilance, general productivity, social outcome, intimacy, and activity level) scores are calculated from the responses. Worst subscale score is 1 (maximum difficulty) and the best score is 4 (no difficulty). This score represents the CHANGE from Baseline in the Activity level subscale. Positive change scores represent improvement (possible range -3 to +3).|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
1421913|NCT01080807|Secondary|Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score|FOSQ-10 consists of 10 questions, on a scale of 1-4(1=extreme difficulty 4=no difficulty), measures impact of sleepiness on activities of daily living. Lower score = more difficulty with activity due to lack of sleep. Total score = MEAN of subscale scores (vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. Worst total score is 5 (maximum difficulty) the best is 20 (no difficulty). This data reports CHANGE in total score from baseline to endpoint, with higher (positive) values representing improvement. Worst possible CHANGE value would be -15 best would be +15.|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with FOSQ-10 at baseline and at endpoint|||Units on a scale||Standard Error|Least Squares Mean
1421914|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Global Satisfaction scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
1421915|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Convenience scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
1421937|NCT01080794|Secondary|Montreal Cognitive Assessment (MoCA)|To screen and follow cognitive function in Parkinson's Disease. The MoCA mean scores were reported for each group at each time point. The MoCA Score Range is 0 - 30, where 26-30 indicates normal cognition.|pre-treatment; 0,1,3, and 6 months post-treatment||||units on a scale||Standard Deviation|Mean
1421916|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last post-baseline observation. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Side Effects scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
1421917|NCT01080807|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint|TSQM is a 14 question questionnaire assessing satisfaction with the medication. 4 scales are generated: side effects, effectiveness, convenience, and global satisfaction. Subjects responded to the questionnaire at Week 3, Week 6, and last observation after baseline. Optional responses are: Extremely Dissatisfied, Very Dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Very Satisfied, and Extremely Satisfied. From the responses, a scale score from 0 - 100 is calculated, with a higher score indicating greater satisfaction. Results from the Effectiveness scale are presented here.|Endpoint|Full analysis set defined as subjects who completed the TSQM at Endpoint (Week 6 or last observation after baseline)|||Units on a scale||Standard Error|Least Squares Mean
1421918|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1421919|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1421920|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1421921|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation (or last observation after baseline))|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1421922|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1421923|NCT01080807|Secondary|Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score|"Mental-health related disability was assessed with the Modified Sheehan Disability Scale (MSDS). The MSDS has three 11-point items, and the participant is asked to rate, on a numerical scale, the extent to which emotional problems have disrupted her/his work, social life, and family life/home responsibilities over the last month. Each item is rated from 0, indicating not at all, to 10, indicating extremely. Scores for the items are summed for a possible score of 0 to 30. The MSDS was performed by the patient at the baseline visit, at Week 3, and at Week 6."|Baseline and week 6 (or last observation after baseline)|Full analysis set defined as subjects who were assessed with MSDS at baseline and at Endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1421938|NCT01080794|Secondary|Parkinson's Disease Questionnaire 39 (PDQ-39)|To assess the quality of life (QOL) in Parkinson's Disease. The PDQ-39 mean scores were reported for each group at each time point. The PDQ-39 Score Range is 0 - 156, where higher the score indicates greater impact on quality of life.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421924|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 6|||Percentage of participants|||Number
1421925|NCT01080807|Secondary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 3|Full analysis set defined as subjects who were assessed with CGI-C at baseline and at week 3|||Percentage of participants|||Number
1421926|NCT01080807|Secondary|Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
1421927|NCT01080807|Secondary|Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 3|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
1421928|NCT01080807|Secondary|Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score|"The Karolinska sleepiness scale is a 10-point scale, on which the participant has to mark his sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 10, which indicates extremely sleepy, can't stay awake. The KSS was performed by the participant at the baseline visit, week 3, and week 6 (or early termination visit). The score recorded is the average of 3 assessments within ±15 minutes at 0400, 0600, and 0800. The data presented here represents the mean change from baseline in the KSS scores of each group."|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
1421929|NCT01080807|Secondary|Change From Baseline to Week 6 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 6|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
1421930|NCT01080807|Secondary|Change From Baseline to Week 3 in Global Assessment of Functioning|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline in the GAF scores of each group.|Baseline and Week 3|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
1421931|NCT01080807|Secondary|Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score|The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by the clinician to rate the social, occupational, and psychological functioning of the patient. A higher score indicates superior functioning and fewer symptoms. The data presented here represents the mean change from baseline to endpoint in the GAF scores of each group.|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.|||Units on a scale||Standard Error|Least Squares Mean
1421932|NCT01080807|Primary|Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint|The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).|Baseline and week 6 (or last observation after baseline)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1421933|NCT01080794|Secondary|The Number All Types of Adverse Events.|To establish the safety and tolerability of rTMS in Parkinson's Disease.|Baseline through Month 6||||incidents of an adverse event|||Number
1422090|NCT01079182|Secondary|Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Days||Standard Deviation|Mean
1421940|NCT01080794|Secondary|Clinical Anxiety Scale (CAS)|To evaluate anxiety in Parkinson's Disease. The CAS mean scores were reported for each group at each time point. The CAS Score Range is 0 - 100, where higher the score indicates greater severity of the anxiety symptoms.|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421941|NCT01080794|Primary|Hamilton Depression Scale (HAM-D)|"To evaluate the depressive mood symptoms in PD.~The HAM-D mean scores were reported for each group at each time point. The HAM-D Score Range is 0 - 56, where higher the score indicates greater severity of depressive mood symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421942|NCT01080794|Primary|Motor Subscale of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)|"To evaluate the motor symptoms in Parkinson's Disease.~The UPDRS-III mean scores were reported for each group at each time point. The UPDRS-III Score Range is 0 - 56, where higher the score indicates greater severity of the motor symptoms."|Pre-treatment; Post-treatment 0,1,3, and 6 months.||||units on a scale||Standard Deviation|Mean
1421943|NCT01080768|Primary|Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method|AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.|Baseline, 4 weeks|The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.|||mL||Standard Error|Least Squares Mean
1421944|NCT01080677|Secondary|Percentage of Participants With Treatment Satisfaction|Following up to 24 hours after treatment, participants were asked to report whether they were satisfied with level of pain relief provided by treatment|24 hours||||percentage of participants|||Number
1421945|NCT01080677|Secondary|Percentage of Participants Experiencing at Least One Adverse Event of Interest|Adverse events may have included abdominal pain, flushing, dizziness, insomnia, or anxiety|24 hours||||percentage of participants|||Number
1421946|NCT01080677|Secondary|Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol||2 hours||||percentage of participants|||Number
1421947|NCT01080677|Primary|Percentage of Participants Reporting Pain Relief at 2 Hrs Post First Administration of Caffeine/Propranolol (Defined as a Decrease in Headache Pain Intensity From Severe or Moderate Headache Pain at Baseline to Mild or no Pain at 2 Hrs)||2 hours||||percentage of participants|||Number
1421948|NCT01080625|Primary|Occurrence of Postreperfusion Syndrome (PRS)|the number of patients who showed PRS (hypotension defined as < 30% of baseline mean arterial pressure [MAP] lasting over 1 min immediately after reperfusion of liver graft) was divided by the total number of patients enrolled for each group|immediately after reperfusion|Initial assessment for eligibility: n=128 32 patients who did not meet the criteria were excluded 96 patients were randomized Contorol (32 patients) --> 1 patient was excluded because of portalvein rupture Epinephrine (33 patients) --> data recording error (1 patient) practice error (1 patient) Phenylephrine group (31 patient)|||percentage of participants|||Number
1421949|NCT01080391|Secondary|QLQ-C30 Global Health Status/Quality of Life Scores|European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Module QLQ-C30 (QLQ-C30 GHS/QoL) is a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life. The minimal important difference for between group differences is 5 points.|Day 1 of Cycles 3, 6, 12, 18|ITT analysis set comprised of all randomized participants.|||scores on a scale||Standard Deviation|Mean
1421950|NCT01080391|Secondary|Duration of Disease Control|Duration of disease control (DDC) was calculated for participants who achieved disease control.DDC was defined as the time in months from randomization to the earlier of documented Progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.|The Intent to treat (ITT) population with participantants who achieved disease control.|||months||95% Confidence Interval|Median
1421951|NCT01080391|Secondary|Duration of Response|Duration of response (DOR) was calculated for subjects who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented Progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.|From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.|The Intent to treat (ITT) population with participantant with participants who achieved a best overall response of PR or better.|||months||95% Confidence Interval|Median
1421952|NCT01080391|Secondary|Disease Control|Number of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants|||participants|||Number
1421953|NCT01080391|Secondary|Overall Response|Number of participants who achieved confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).|From randomization through the data cutoff date of 16 June 2014.Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants|||participants|||Number
1421994|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
1421954|NCT01080391|Secondary|Overall Survival|Time elapsed between the randomization date and the date of death. Participants who were still alive were censored at the date when the subject was last known to be alive or the data cutoff date, whichever occurs earlier. The median and all but one of the 95% confidence limits were not estimable. Instead, the number of participants who died or were censored are reported.|From randomization through the data cutoff date of 16 June 2014. Median follow up time was approximiately 32 months.|ITT analysis set comprised of all randomized participants|||participants|||Number
1421955|NCT01080391|Primary|Progression-free Survival (PFS)|Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). 1 or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).|From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.|ITT analysis set comprised of all randomized participants|||months||95% Confidence Interval|Median
1421956|NCT01080326|Primary|Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair|"At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage.~Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated."|2 days post-operation||||participants|||Number
1421957|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|"To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline."|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population|||scores on a scale||95% Confidence Interval|Least Squares Mean
1421958|NCT01080300|Secondary|Evaluate Safety of G-ER|Evaluate safety of G-ER,change from average daily frequency & severity score of HFs from baseline to end point(wk 24),assess sleep interference, depression,suicidal ideation, quality of life, patient and investigator global impression of change|6mt treatment, 1mt f/u|||||||
1421959|NCT01080300|Primary|Evaluate Efficacy of G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.|To assess the efficacy of G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.|Baseline, Week 4, and Week 12|Intent-to-treat (ITT) Population|||hot flashes||95% Confidence Interval|Least Squares Mean
1421960|NCT01080261|Secondary|Clinical Procedural Success (Percentage of Participants)|Expressed as percentage of participants in whom mean lesion diameter stenosis was <30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death.|While participant is in the hospital|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421961|NCT01080261|Secondary|Technical Success (Percentage of Stents)|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|At time of index procedure|Analysis was intention to treat|||percentage of stents|Participants||Number
1421962|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days - 9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421963|NCT01080261|Secondary|Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|0-30 Days (Early)|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421964|NCT01080261|Secondary|Target Lesion Failure (TLF) (Percentage of Participants With an Event)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421965|NCT01080261|Secondary|Target Vessel Failure (TVF) (Percentage of Participants With an Event)|Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421966|NCT01080261|Secondary|Target Lesion Revascularization (Percentage of Participants With an Event)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. Reported as percentage of participants who experienced a TLR.|9 months|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421967|NCT01080261|Secondary|Target Vessel Revascularization (Percentage of Participants With an Event)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421968|NCT01080261|Secondary|Cardiac Death (Percentage of Participants With an Event)|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421969|NCT01080261|Secondary|All-cause Death (Percentage of Participants With an Event)|Participants who died from any cause|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421970|NCT01080261|Secondary|Myocardial Infarction (MI) (Percentage of Participants With an Event)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin <ULN); if no new Q-waves total CK or troponin >3× ULN (baseline troponin <ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× ULN|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421971|NCT01080261|Primary|Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)|A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.|9 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1421972|NCT01080248|Secondary|Overall Survival||1 year||||participants|||Number
1421973|NCT01080248|Secondary|Median Survival||Length of follow-up was 35 weeks||||weeks||Full Range|Median
1421974|NCT01080248|Secondary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time to progression.~Progressive disease - at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment.|||weeks|||Number
1421975|NCT01080248|Primary|Response Rate by RECIST Criteria.|"Response rate = complete response + partial response per RECIST~Complete response - disappearance of all target and non-target lesions.~Partial response - at least a 30% decrease in the sum of the longest diameter of the target lesions, taking as reference the baseline sum longest diameter"|Follow-up was approximately 9 weeks|One participant was removed from study for adverse event prior to first response assessment. The remaining participant had progressive disease per RECIST while on treatment.|||percentage of participants|||Number
1421976|NCT01080209|Secondary|Number of Patients With Vision Loss in the Study Eye|Vision loss is assessed by Best Corrected Visual Acuity (BCVA) in the study eye. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Severe vision loss is a ≥30 letter decrease in BCVA. Moderate vision loss is a ≥15 and <30 letter decrease in BCVA. No or mild vision loss is <15 letter decrease in BCVA. Baseline of the parent study is defined as the point of the first study treatment.|Baseline of Parent Study, Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study|||Patients|||Number
1421977|NCT01080209|Primary|Number of Patients With No Visible Implants in the Study Eye|Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.|Month 36|Safety Population: all enrolled patients, who received a sham or active study treatment of intravitreal Brimonidine Tartrate PS DDS in the parent study|||Patients|||Number
1422011|NCT01080131|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study|The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.|Baseline to Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||percentage of participants|||Number
1421978|NCT01080196|Other Pre-specified|Six Minute Walk Distance (6 MW) (m)|The 6 min walk (6 MW) test, a measure of the distance (m) a subject walks in 6 min, was used to assess overall mobility. Self-selected gait-speed was measured over a 50-ft course. Individuals were instructed to walk at a comfortable pace starting at the word “go.” They were asked to walk out 25-ft and back. Timing took place from the command “go” until the starting line was crossed on the way back. Participants were allowed to use any walking aid they used on a daily basis.|12 months||||Six Minute Walk Distance (m)||95% Confidence Interval|Mean
1421979|NCT01080196|Other Pre-specified|Activities Specific Balance Confidence (ABC) (%)|Self-reported level of balance confidence was assessed with the Activities Specific Balance Confidence (ABC) Scale. This 16-item questionnaire asks participants to score their level of confidence in performing situation-specific activities such as “reaching at eye level,” “reaching on tiptoes,” “picking up slipper from floor,” and “walking in crowded mall” “without losing . . . balance or becoming unsteady.” Each item is scored from 0 to 100%, with 0% being no confidence and 100% being full confidence in the ability to perform the activity without losing balance. The total ABC Scale score is the average sum of the individual item scores.|12 months||||percent||95% Confidence Interval|Mean
1421980|NCT01080196|Other Pre-specified|Leg Extension Power (W)|Leg extension power in watts (W) of each leg individually was measured on a Nottingham power rig. After three warm-up trials at 50%, 75%, and 100% effort, six test trials and the average of the three highest trials per leg were recorded.|12 months||||Leg Extension Power (W)||95% Confidence Interval|Mean
1421981|NCT01080196|Other Pre-specified|Thigh Lean Tissue Cross Sectional Area (CSA) (cm^2)|Magnetic resonance imaging (MRI) was used for determination of the cross-sectional area (CSA) (cm^2) of lean muscle mass. Bilateral MRI scans of the thighs were obtained in a coronal plane and the midpoint of the thigh was determined and defined as halfway between the superior margin of the femoral head and the inferior margin of the femoral condyles. Axial imaging (5 mm thick slices at 1 cm intervals) of the legs was then performed over 1/2 the length of the femur, centered at the midpoint of the thigh. Five images from the middle 1/3 of each thigh were used to determine average CSA of lean tissue.|12 months||||Thigh Lean Tissue CSA (cm^2)||95% Confidence Interval|Mean
1421982|NCT01080196|Primary|The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study||12 months||||The number of days survived without a fa||Standard Error|Mean
1421983|NCT01080131|Secondary|Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab|"Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||mg/L||Standard Deviation|Mean
1421984|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab|"High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||mg/L||Standard Deviation|Mean
1421985|NCT01080131|Secondary|Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
1421986|NCT01080131|Secondary|Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for swelling on the following 4-point scale:~no swelling;~palpable;~visible;~bulging beyond the joint margins.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
1422091|NCT01079182|Secondary|Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1421987|NCT01080131|Secondary|Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab|"The study physician assessed the most affected joint for tenderness on the following 4-point scale:~no pain;~participant states that there is pain;~participant states there is pain and winces;~participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
1421988|NCT01080131|Secondary|Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|"The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.~The physician completed the physician’s global assessment of response to treatment without viewing any of the patient’s assessments.~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
1421989|NCT01080131|Secondary|Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
1421990|NCT01080131|Secondary|Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab|"Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).~Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2."|72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.|Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||percentage of participants|||Number
1421991|NCT01080131|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Participants met the definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.~Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||flares per patient per year||95% Confidence Interval|Mean
1421992|NCT01080131|Secondary|Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~• Increasing/renewed gout pain in an affected joint before flare has resolved completely."|From randomization to the end of the second extension period (72 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||days||95% Confidence Interval|Median
1421993|NCT01080131|Secondary|Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme|For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.|From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.|||Percentage of participants|||Number
1421995|NCT01080131|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|"For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. N indicates the number of participants with available data in each analysis."|||mg/L||95% Confidence Interval|Least Squares Mean
1421996|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.|||participants|||Number
1421997|NCT01080131|Secondary|Physician’s Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
1421998|NCT01080131|Secondary|Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
1421999|NCT01080131|Secondary|Patient’s Global Assessment of Response to Treatment|Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.|72 hours post-dose and 24 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.|||percentage of participants|||Number
1422000|NCT01080131|Primary|Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks|This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During 24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment|||Participants|||Number
1422001|NCT01080131|Secondary|Physician’s Global Assessment of Response to Treatment|The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s own assessments (pain intensity and patient’s global assessment of response to treatment).|72 hours post-dose and 24-weeks post-dose.|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available for this endpoint at the specified time point.|||percentage of participants|||Number
1422002|NCT01080131|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.|||mg||Standard Deviation|Mean
1422024|NCT01079962|Secondary|Change From Baseline in Lipid Levels at Week 12|The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||Milligram/decilitre (mg/dL)||Standard Deviation|Mean
1425741|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||6 months|||||||
1422003|NCT01080131|Secondary|Percentage of Participants Who Took Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.|||percentage of participants|||Number
1422004|NCT01080131|Secondary|Time to First Intake of Rescue Medication|"Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.~Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.~Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks)."|For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.|||hours||95% Confidence Interval|Median
1422005|NCT01080131|Secondary|Mean Number of New Gout Flares Per Patient During 24 Weeks|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint(at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|24 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||new flares per patient||Standard Deviation|Mean
1422006|NCT01080131|Secondary|Time to the First New Gout Flare During 24 Weeks|"Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely."|From randomization to the end of the first extension period (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||days||95% Confidence Interval|Median
1422007|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)|Patient’s assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.|||mm||Standard Error|Least Squares Mean
1422008|NCT01080131|Secondary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||mm||Standard Error|Least Squares Mean
1422009|NCT01080131|Secondary|Pharmacokinetic Concentrations|Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.|12 weeks post-dose|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||µg/mL||Standard Deviation|Mean
1422010|NCT01080131|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose|Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||mm||Standard Error|Least Squares Mean
1425742|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||12 months|||||||
1422012|NCT01080131|Secondary|SF 36 Physical Function Score at Week 12|SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1422013|NCT01080131|Secondary|Time to Complete Resolution of Pain; Survival Analysis|Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS): All patients that received study drug.|||hours||95% Confidence Interval|Number
1422014|NCT01080131|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)|Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|Baseline to 7 days post-dose (randomization)|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||hours||95% Confidence Interval|Median
1422015|NCT01080131|Primary|Time to First New Flare: Survival Analysis During the 12 Weeks of Study|Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.|Baseline to 12 weeks|Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Days||95% Confidence Interval|Median
1422016|NCT01080118|Secondary|Time to Intubation|Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.|||seconds||95% Confidence Interval|Mean
1422017|NCT01080118|Primary|Successful Endotracheal Intubation|A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.|120 seconds|The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.|||% successful|||Number
1422018|NCT01079988|Secondary|Patient's Global Psoriasis Assessment (PGPA)|"The PGPA consisted of a single self-explanatory item:~On a scale from 0 to 10, with 0 being no psoriasis and 10 the worst psoriasis that you can imagine, please rate the state of your psoriasis right now.~Note: Consider only your skin condition and do not consider other aspects that may be related to your psoriasis (such as psoriatic arthritis)."|12 weeks|One patient withdrew|||PGPA score||Standard Deviation|Mean
1422019|NCT01079988|Primary|Physician's Global Assessment (PGA) of Change Over Time (Good or Better)|"The PGA response was classified according to the following categories by changes in all clinical signs and symptoms as compared to baseline:~Cleared: Remission except for residual manifestations such as mild erythema (100% improvement) Excellent: Improvement of 75%-99% except for residual manifestations such as mild erythema Good: Improvement of 50%-74%"|12 weeks||||participants|||Number
1422020|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|Per protocol (PP) population included those participants for whom primary and secondary efficacy endpoints were all measured, and who did not meet the withdrawal criteria and showed 75 percent of medication compliance.|||mmHg||Standard Deviation|Mean
1422021|NCT01079962|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 14 (follow-up visit)|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||Participants|||Number
1422022|NCT01079962|Secondary|Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12|The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||mmHg||Standard Deviation|Mean
1422023|NCT01079962|Secondary|Change From Baseline in Blood Glucose Levels at Week 12|The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline.|Baseline and Week 12|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1422025|NCT01079962|Secondary|Change From Baseline in Aortic Pulse Pressure (APP) at Week 4|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline.|Baseline and Week 4|ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure.|||mmHg||Standard Deviation|Mean
1422026|NCT01079962|Secondary|Change From Baseline in Heart Rate at Week 4 and Week 12|The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Beats per minute (bpm)||Standard Deviation|Mean
1422027|NCT01079962|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12|Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Meters per second (m/s)||Standard Deviation|Mean
1422028|NCT01079962|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12|Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Ratio||Standard Deviation|Mean
1422029|NCT01079962|Secondary|Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12|The change in aortic BP (aortic systolic blood pressure [SBP], aortic diastolic blood pressure [DBP] and aortic mean blood pressure [BP]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline.|Baseline, Week 4 and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||mmHg||Standard Deviation|Mean
1422030|NCT01079962|Primary|Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12|The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.|Baseline and Week 12|"ITT population included all participants who had received at least 1 dose of the study medication or comparator and at least 1 post-dose measurement of aortic pulse pressure. n signifies those participants who were evaluated for this measure at the specified time point."|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1422031|NCT01079949|Secondary|Follicular Levels of Testosterone (T) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1422032|NCT01079949|Secondary|Follicular Levels of Estradiol (E2) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||pg/mL||Standard Deviation|Mean
1422033|NCT01079949|Secondary|Follicular Levels of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and Human Chorionic Gonadotropin (hCG) at Ovum Pick up (OPU)||OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||milli international unit (mIU)/mL||Standard Deviation|Mean
1422034|NCT01079949|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication.N (number of participants analyzed) signifies those participants with plasma E2 levels at r-hCG day."|||picogram/milliter (pg/mL)||Standard Deviation|Mean
1422035|NCT01079949|Secondary|Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)||Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||IU||Standard Deviation|Mean
1422036|NCT01079949|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first r-hFSH injection (S1) until day on which r-hCG was administered (r-hCG day).|Day 1 of stimulation period (S1) up to r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||days||Standard Deviation|Mean
1422037|NCT01079949|Secondary|Number of Participants in Whom Recombinant Human Chorionic Gonadotropin (r-hCG) Was Not Administered Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
1422038|NCT01079949|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
1422039|NCT01079949|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred multiplied by 100.|Day 35-42 post OPU (34-38 hours post r-hCG day {end of stimulation cycle [approximately 9 days]})|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||percent sacs per embryo||Standard Deviation|Mean
1422040|NCT01079949|Secondary|Number and Quality of Embryos|Embryos were classified into 5 different grades (1 to 5) based on their capacity of implantation. Grade 1 embryos were those with best capacity of implantation and Grade 5 embryos were those with worst capacity of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who continued with follicular development."|||embryos|||Number
1422041|NCT01079949|Secondary|Number of Fertilized Oocytes at Stage 2 Pronuclei (2PN) or Higher Than 2PN|Oocytes were fertilized using ICSI technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. Fertilized oocytes at stage higher then 2PN are those oocytes which consist more than 2 pronuclei like oocyte having 3 pronuclei termed as 3PN, oocyte having 4 pronuclei termed as 4PN.|Day 35-42 post r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||oocytes|||Number
1422042|NCT01079949|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||2PN oocytes|||Number
1422043|NCT01079949|Secondary|Endometrial Thickness on Recombinant Human Choriogonadotropin (r-hCG) Day|Endometrial thickness measurement was performed on the day of r-hCG administration.|r-hCG day (end of stimulation cycle [approximately 9 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||mm||Standard Deviation|Mean
1422044|NCT01079949|Secondary|Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 9 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||follicles||Standard Deviation|Mean
1422045|NCT01079949|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
1422046|NCT01079949|Primary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||cycles|||Number
1422047|NCT01079949|Primary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|S1 to 1 month ± 1 week post r-hCG day (end of stimulation cycle [approximately 9 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
1422048|NCT01079949|Primary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity is assessed based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage or atretic.|OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||mature oocytes|||Number
1422049|NCT01079949|Primary|Number of Oocytes Retrieved|Number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.|Ovum pick-up (OPU) day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 9 days}])|"Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication. N (number of participants analyzed) signifies those participants who underwent ovum pick up."|||oocytes||Standard Deviation|Mean
1422050|NCT01079936|Primary|Participants With Grade 3 =/> Adverse Events|Number of participants experiencing adverse events above a Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.|Day 90 after stem cell transplant||||participants|||Number
1422051|NCT01079936|Primary|Number of Participants With Day 30 DLT (Overall Study, Phase I/Phase II)|Dose limiting toxicity (DLT) was defined as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT.|Day 30 following transplant||||participants|||Number
1422052|NCT01079936|Primary|Number of Participants With Response (CR at Day 90)|Response is defined as the event that the participant is alive with complete response (CR) at day 90 (+/-30 days). CR defined as: A) Absence of monoclonal protein in urine and serum when analyzed by immunofixation electrophoresis. B) The bone marrow should be normal by morphological examination with <5% plasma cells. There should be < 1% aneuploid light chain restricted population by flow cytometry for DNA/cIg. C) While healing of bone lesions not required, no new lytic lesion should appear. Further compression fracture of spine will be not considered as progressive disease.|Day 90 after stem cell transplant||||participants|||Number
1422053|NCT01079936|Primary|Maximum Tolerated Dose (MTD) of Lenalidomide|There were 4 doses of lenalidomide in the dose escalation phase: 25 mg, 50 mg, 75 mg, and 100 mg. The first 12 patients were treated at these dose levels (3 patients per level) and safety assessed at each level. The MTD dose level was to be the level at which participants at each lenalidomide dose level had no dose limiting toxicity (DLT). DLT defined as as regimen-related death, graft failure, grade 3 or 4 atrial fibrillation, grade 4 deep venous thrombosis, or pulmonary embolism before day 30 after auto-HCT. Each participant received a fixed dose of Melphalan plus one of the four doses 25, 50, 75 or 100 mg of Lenalidomide orally for each of 7 days, -8 to -2 pre transplant.|Assessed at 21-28 Day Cycle|Of the 16 participants in Phase I, two participants were not eligible for study due to first remission status, and two were eligible but did not receive stem cell transplant due to other issues.|||mg/day|||Number
1422054|NCT01079832|Secondary|Clinical Response Rate|Percentage of patients with a clinical response following RECIST (Response Evaluation Criteria in Solid Tumors) Criteria: Confirmed complete response(CR), Stable disease (SD), partial response (PR), or without progressive disease (PD).|at 6 months from study entry|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1422055|NCT01079832|Secondary|Quality of Life||After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.|Participant surveys were unreliably returned to investigators, making this analysis not meaningful.||||||
1422056|NCT01079832|Secondary|Median Overall Survival|Length of time patients survived at study end.|24 months|Intent to treat|||months||95% Confidence Interval|Median
1422057|NCT01079832|Secondary|Disease-free Survival|Median disease free survival|completion of study at 24 months|Intent to treat|||months||95% Confidence Interval|Median
1422058|NCT01079832|Primary|Acute Toxicity Rate|The incidence of grade 3 or 4 possible SBRT-related non-hematological toxicities observed during a 6 month period.|at 6 months after treatment|Intent to treat|||percentage of participants|||Number
1422059|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4) (Continued)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; ULN=upper limit of normal; LLN=lower limit of normal. ALT, AST (*ULN): Grade 1=1.25-2; Grade 2=2.6-5; Grade 3=5.1-10; Grade 4= >10. Bilirubin (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2.5; Grade 3=2.6-5; Grade 4= >5. Albumin (g/dL): Grade 1=3- <LLN; Grade 2=2-2.9; Grade 3= <2. Lipase (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-3; Grade 3=3.1-5; Grade 4= >5. BUN/urea (*ULN): Grade 1=1.25-<2.6; Grade 2=2.6-<5.1; Grade 3=5.1-10; Grade 4= >10. Chloride, high (mEq/L): Grade 1=113-<117; Grade 2=117-<121; Grade 3=121-125; Grade 4= >125. Potassium, low (mEq/L): Grade 1=3-3.4; Grade 2=2.5-<3; Grade 3=2-<2.5; Grade 4=<2. Potassium, high (mEq/L): : Grade 1= 5.6-<6.1; Grade 2=6.1-<6.6; Grade 3=6.6-7; Grade 4= >7. Sodium, high (mEq/L): Grade 1=146<151; Grade 2=151-<155; Grade 3=155-<160; Grade 4= >=160.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study medication; n=number of participants with laboratory results available|||Participants|||Number
1422060|NCT01079806|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormality (Grades 1-4)|Toxicities graded per Division of AIDS criteria, Version 1.0, and modified World Health Organization criteria. INR=international normalization ratio of prothrombin time; ULN=upper limit of normal. Hemoglobin (g/dL): Grade 1=10-10.9; Grade 2=9-9.9; Grade 3=7-8.9; Grade 4= <7. Platelets (/mm^3): Grade 1=100,000-124,999; Grade 2=50,000-99,999; Grade 3=25,000-49,999; Grade 4= <25,000. INR (*ULN): Grade 1=1.1-1.5; Grade 2=1.6-2; Grade 3=2.1-3; Grade 4= >3. WBC (/mm^3): Grade 1=2000-2500; Grade 2=1500-1999; Grade 3=1000-1499; Grade 4= <1000. Neutrophils (/mm^3): Grade 1=1000-1300; Grade 2=750-999; Grade 3=500-749; Grade 4= <500.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study medication; n=number of participants with laboratory results available|||Participants|||Number
1422061|NCT01079806|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Related AEs, Grade 2-4 Related AEs, Grade 3-4 AEs, Malignancies, ALT Flares, and Hepatic Disease Progression|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death. ALT=alanine aminotransferase.|Day 1 through Week 48 on blinded therapy|All randomized participants who received at least 1 dose of study drug|||Participants|||Number
1422062|NCT01079806|Secondary|Percentage of Participants With Hepatitis B e (HBe) Seroconversion at Week 48|HBe seroconversion=undetectable HBe antigen and detectable anti-HBe antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
1422063|NCT01079806|Secondary|Percentage of Participants With Serum Alanine Aminotransferase ≤1*Upper Limit of Normal at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
1422092|NCT01079182|Secondary|Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Days||Standard Deviation|Mean
1422064|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus DNA <Limit of Quantitation (LOQ) at Week 48|LOQ=29 IU/mL. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
1422065|NCT01079806|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) DNA <50 IU/mL at Week 48|While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
1422066|NCT01079806|Primary|Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48|Suppression=HBV DNA<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.|At Week 48|The first 123 participants who were randomized and received treatment (referred to as the Primary Cohort)|||Percentage of participants|||Number
1422067|NCT01079741|Secondary|NY-ESO-1 Expression by IHC|Analysis of immune cell infiltration at the injection site by IHC. IHC analysis of immune cell infiltration was performed for each arm using a scoring system. 0: No expression of the marker of interest, 1: single cells or small clusters (<5 cells together) expressing marker of interest, 2: medium size clusters of cells expressing marker of interest, and 3: huge and homogeneously positive clusters of cells expressing marker of interest.|up to 52 weeks||||units on a scale||Standard Deviation|Mean
1422068|NCT01079741|Secondary|CD4+ and CD8+ Response|Cellular response evaluated for the induction of cellular T cell (CD4+ and CD8+) immunity to subcutaneous vaccination with NY-ESO-1 protein in combination with Poly-ICLC when given with or without Montanide. Number of participants with increase CD4+ and CD8+ levels.|Up to 52 weeks||||Participants|||Count of Participants
1422069|NCT01079741|Primary|Phase I, Number of Participants With SAE and DLT|Safety measured by number of Serious Adverse Events per the CTEP v4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and Dose Limiting Toxicity (DLT).|52 weeks||||Participants|||Count of Participants
1422070|NCT01079598|Secondary|Cessation of Flow Reflux Through the Perforator Vein|Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
1422071|NCT01079598|Secondary|CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)|CEAP Classification at Month 6 will be reported.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
1422072|NCT01079598|Secondary|Cessation of Flow Through the Perforator Vein|Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
1422073|NCT01079598|Primary|Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.|QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.|6 months|Analysis was not able to be completed due to very low enrollment and limited data available. No results available.||||||
1422074|NCT01079390|Primary|Cortical Thickness Changes at 5-7 Weeks Post-Treatment|All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software.|2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline|We combined low and high dose acupuncture into one group because we found there were not clinical differences between the two group.|||millimeters||Standard Deviation|Mean
1422075|NCT01079390|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment|The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain.|One post-treatment measurement 5-7 weeks after baseline||||units on KOOS scale||Standard Deviation|Mean
1422076|NCT01079299|Primary|Median Time to Wound Closure at 9 Months|Median number of days for complete healing in each treatment group|9 months||||median number of days for complete heali||Standard Error|Median
1422088|NCT01079182|Secondary|Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1422089|NCT01079182|Secondary|Percentage of Participants on Adalimumab Monotherapy||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1425743|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||6 months|||||||
1422077|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||Episodes/100 years of patient exposure|||Number
1422078|NCT01079234|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||Episodes/100 years of patient exposure|||Number
1422079|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). FPG baseline values were missing for 6 subjects. The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||mmol/L||Standard Deviation|Mean
1422080|NCT01079234|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 6 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
1422081|NCT01079234|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 52|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). The subjects randomised to 2 IDeg arms during the main trial were pooled into the IDeg OD F in extension trial.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1422082|NCT01079234|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1422083|NCT01079195|Secondary|Evaluation of Adverse Events (AEs) Leading to Discontinuation of Tarka and a Summary of All AEs Possibly or Probably Related to Tarka by Frequency and Severity|The number of AEs leading to Tarka discontinuation are summarized. AEs that were considered by the investigator to be possibly or probably related to Tarka are summarized by the severity of the AE (classified as mild, moderate, or severe). AEs considered possibly or probably related to Tarka that led to the discontinuation of Tarka are also presented by severity.|6 months|This analysis used the safety analysis population, which included any participant who took at least one dose of Tarka and had at least one follow-up visit.|||Events|||Number
1422084|NCT01079195|Secondary|Percentage of Participants Achieving Target Blood Pressure (Less Than 140/90) at Study End and the Need for Other Antihypertensive Drugs, Clustered by Type(s) of Drugs Added to Tarka.|The percentages of participants achieving and not achieving the target blood pressure of less than 140/90 mmHg at the end of the study are presented. Percentages of participants taking Tarka only or taking Tarka plus another antihypertensive drug are summarized by type of drug: beta blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium antagonists, diuretics, and angiotensin II (AT-II) receptor antagonists. Participants taking drugs that did not fit any of the above groups (Other), unknown drugs (Unknown), or more than one additional antihypertensive agent are also summarized.|6 months|2122 participants were excluded from the analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).|||Percentage of participants|||Number
1422085|NCT01079195|Primary|Reduction in Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to Study End|"Participants were to be followed for 6 months. Changes in systolic and diastolic blood pressure were assessed by comparing the blood pressure measurements obtained at the end of Tarka treatment (approximately 6 months) to baseline values. For this analysis of effectiveness the last available value was considered the analysis time point end of study."|Baseline to 6 months/study end|2122 participants were excluded from this analysis for the following reasons: age less than 18 years (1), no diagnosis of hypertension (18), not at risk for diabetes (1650), no follow-up blood pressure values (48), no baseline blood pressure values (360), and started Tarka at/after first follow-up visit (45).|||mmHg||Standard Deviation|Mean
1422086|NCT01079182|Secondary|Mean Equivalent Dose of Prednisolone|The mean equivalent dose of prednisolone was calculated based on the International Standard for comparison of different glucocorticoid products.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||mg/day||Standard Deviation|Mean
1422087|NCT01079182|Secondary|Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents|Participants with concomitant pain relief/anti-inflammatory agents like analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and systemic glucocorticoids were assessed during the study period.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1425744|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||12 months|||||||
1425745|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||6 months|||||||
1422093|NCT01079182|Secondary|Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months||At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1422094|NCT01079182|Secondary|Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks|The impairment of daily activities was based on participant recall of events that occurred over the 4 weeks before the visit. Percentage of participants with impairment for 0, less than 7, 7 to 14, and greater than 14 days was assessed.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1422095|NCT01079182|Secondary|Percentage of Participants Achieving ASAS Partial Remission Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a partial remission, participants had to have values of 2 or less (on a scale of 10) in each of the 4 domains.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1422096|NCT01079182|Primary|Number of Participants With Drug-Related Adverse Events (AEs)|An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.|From signing of informed consent up to 24 months|Safety analysis set: Participants who received at least one dose of adalimumab.|||Participants|||Number
1422097|NCT01079182|Secondary|Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria|This is a four domain (participant global assessment of disease activity, assessment of spinal pain, assessment of function (BASFI), and assessment of duration/severity of morning stiffness (mean of BASDAI questions 5 and 6)), participant-reported assessment scored on a scale from 0 (best) to 10 (worst). To qualify for a 20% improvement, participants were required to have an improvement of greater than or equal to 20% and greater than or equal to 1 unit in at least 3 domains, and no worsening of greater than or equal to 20% and greater than or equal to 1 unit in the remaining domain. To achieve a 40% improvement, participants were required to have an improvement of greater than or equal to 40% and greater than or equal to 2 units in at least 3 domains, and no worsening at all in the remaining domain.|At 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1422098|NCT01079182|Secondary|Mean Duration of Morning Stiffness|Participants accessed the duration of morning stiffness in 15 minute intervals from 0 to 2 hours. Data are reported as the mean duration of morning stiffness ± standard deviation.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||minutes||Standard Deviation|Mean
1422099|NCT01079182|Secondary|Percentage of Participants With Morning Stiffness|Morning stiffness was a participant-reported assessment. The number of participants with morning stiffness were assessed at each visit.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1422100|NCT01079182|Secondary|Mean Participant Pain Score|Using the BASDAI questionnaire, participants assessed the overall level of AS neck, back or hip pain experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Score on scale||Standard Deviation|Mean
1422101|NCT01079182|Secondary|Mean Participant Fatigue Score|Using the BASDAI questionnaire, participants assessed the overall level of fatigue/tiredness experienced by him/her. It was scored on a numerical rating scale from 0 (no symptoms) to 10 (severe symptoms).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Score on scale||Standard Deviation|Mean
1422102|NCT01079182|Secondary|Mean Global Assessment of Disease Activity Score|Global Assessment of Disease Activity was a participant-reported measure that evaluated disease activity. It was scored on a scale that ranged from 0 to 10; lower scores indicated better patient status.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Score on scale||Standard Deviation|Mean
1422103|NCT01079182|Secondary|Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score|The BAS-G was a participant-reported instrument with two items. In the first item, the participant rated the effect of their disease over the last week, and in the second item, the participant rated the effect of their disease over the previous 6 months. Each item of the BAS-G was scored on a scale ranging from 0 (no effect) to 10 (very severe effect). The mean of the two scores was the total BAS-G score and the MCID was 1.5.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||BAS-G score||Standard Deviation|Mean
1422104|NCT01079182|Secondary|Mean Plasma Concentrations of C-Reactive Protein (CRP)|Plasma concentrations of CRP were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||mg/L||Standard Deviation|Mean
1422105|NCT01079182|Secondary|Mean Erythrocyte Sedimentation Rate (ESR)|Plasma concentrations of ESR were assessed as a marker of systemic inflammation that provided insights into the overall anti-inflammatory effect of rheumatologic therapies.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||mm/hour||Standard Deviation|Mean
1423129|NCT01072357|Primary|Number of Participants With Graft Failure at Week 39 and 52|Time from surgery to overall graft failure (regardless of cause). Graft failure was monitored throughout the entire study, but only the time points at which graft failure occurred are reported below.|12 months||||Participants|||Count of Participants
1422106|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||BASFI score||Standard Deviation|Mean
1422107|NCT01079182|Primary|Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||BASDAI score||Standard Deviation|Mean
1422108|NCT01079182|Secondary|Percentage of Participants With Extraspinal Manifestations|Extraspinal manifestations (enthesitis, dactylitis, uveitis, psoriasis, and Inflammatory Bowel Disease (IBD)) were assessed by investigators and reported on the basis of their clinical evaluation and participant records.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Percentage of participants|||Number
1422109|NCT01079182|Secondary|Mean Number of Involved Peripheral Joints|Peripheral joints were assessed by Tender Joint Counts (TJC) and Swollen Joint Counts (SJC), using pressure and joint manipulation during physical examination. Seventy-eight TJC and 76 SJC were evaluated and a score of 0 (not tender or swollen) or 1 (tender or swollen) was assigned for each joint with a higher total score indicating a greater number of involved joints.|At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months|Full analysis set: Participants with adequate data available for evaluation of effectiveness.|||Joints||Standard Deviation|Mean
1422110|NCT01079143|Secondary|Incidence (Number) of Participants With Graft Losses|If a participant underwent a graft nephrectomy, then the day of nephrectomy was considered as the day of graft loss.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
1422111|NCT01079143|Secondary|Incidence (Number) of BPAR|A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Number of participants|||Number
1422112|NCT01079143|Secondary|Severity of BPAR|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.~Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.~Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
1422113|NCT01079143|Secondary|Type of Biopsy Proven Acute Rejection (BPAR)|"A biopsy proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB or III as per 2005/2007 Banff histological classification system.~Biopsy graded IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising > 25% of the lumenal area.~Biopsy graded III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)."|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
1422114|NCT01079143|Secondary|Treatment Failures|A treatment failure is defined as biopsy proven acute rejection (BPAR), a graft loss, a death or a loss to follow up. It was assessed between randomization and 6 and 12 months post-transplantation.|M6 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Number of Participants|||Number
1422115|NCT01079143|Secondary|Change in Urine Protein/Creatinine Ratio (Without Imputation)|One of the factors associated with EMT progression between M3 and M12 according to univariate analysis (ITT biopsies M3 & M12).|Month 3 (baseline), Month 12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||mg/mmol||Standard Deviation|Mean
1422116|NCT01079143|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR) at M12 From Baseline (M3) - ANCOVA Model|The average patient renal function was evaluated on the basis of eGFR was calculated according to the abbreviated MDRD formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).|Baseline (M3), M12|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||mL/min/1.73m²||Standard Deviation|Mean
1422117|NCT01079143|Secondary|Change From Baseline (M3) in Estimated Glomerular Filtration Rate (eGFR)|"eGFR was calculated according to the abbreviated Modification of Diet in Renal Disease (MDRD) Formula and creatinine clearance according to the Cockcroft-Gault formula (mL/min/1.73m²).~LOCF = Last observation carried forward"|M3 (baseline) to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1422118|NCT01079143|Secondary|Incidence (Number) of Subclinical Rejections and Borderline Lesions|"Incidence of subclinical rejections and borderline lesions with regards to histological evidence of rejection with clinical findings.~Subclinical rejections: rejection without clinical symptoms which is diagnosed by chance when a graft biopsy is performed.~Clinically suspected BPAR: rejection suspected because of the presence of clinical symptoms (fever, pain, increase of creatinine) and then confirmed by the graft biopsy.~Borderline lesions: suspicious for acute T-cell mediated rejection. This category is used when no intimal arteritis is present, but there are foci of tubulitis with minor interstitial infiltration or interstitial infiltration with mild tubulitis."|M3|ITT population: All patients randomized in the study who received at least one dose of the study treatment.|||Participants|||Number
1422119|NCT01079143|Secondary|Change in EMT Score|"Change (M12 - M3) in EMT Score. Progression in EMT score is defined as an increase by >=1 of EMT score from M3 to M12.~EMT score 0 (the best): <1 EMT score 1 (the better) : 1-10% of tubular atrophy EMT score 2 : 10-25% of tubular atrophy EMT score 3 : 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||scores on a scale||Standard Deviation|Mean
1422120|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Score|"Incidence and severity of EMT score. The intensity of EMT markers expression present and detectable in the renal graft at an early stage following transplantation is known as EMT score.~EMT score 0 (the best): <1 EMT score 1 (the better): 1-10% of tubular atrophy EMT score 2: 10-25% of tubular atrophy EMT score 3: 25-50% of tubular atrophy EMT score 4 (the worst): >50% of tubular atrophy"|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||participants|||Number
1422121|NCT01079143|Secondary|Number of Participants With Epithelial-mesenchymal Transition (EMT) Status|Incidence and severity of EMT status. EMT status was determined centrally using the graft biopsy taken at 3 months. The result was quickly obtained (within 7 to 15 days) and sent to the company in charge of randomization in order to allocate each patient to a treatment group and to provide the investigator with this information without confirming EMT status.|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Participants|||Number
1422122|NCT01079143|Secondary|Number of Participants With Progression of Renal Fibrosis Using Numerical Quantification|Comparisons according to epithelial-mesenchymal transition (EMT) profile and immunosuppressive treatment|M3 to M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Participants|||Number
1422123|NCT01079143|Secondary|Change in Percentage of Interstitial Fibrosis (IF) by Numerical Quantification|Percentage of IF measured by numerical quantification. The IF percentage was transposed in grade according to the following rule: grade 0 for an IF % ≤5%, grade I for an IF % ranging from >5% to < 25%, grade II for an IF % ranging from 25 to 50%, grade III for an IF % >50%. Interstitial graft fibrosis has been identified as the primary cause of graft loss following death with a functional graft [3-5].|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Percentage of IF||Standard Deviation|Mean
1422124|NCT01079143|Secondary|Risk Factors of IF/TA Progression|"Composite factors regarding fibrosis progression at 12 months using a logistic regression model; the parameters initially considered concerned the demographic characteristics of both recipient and donor, transplantation characteristics, hypertension, diabetes, study treatments, immunosuppression, EMT, IF/TA, function at M3, the onset of acute rejection, the presence of anti-donor antibodies at M12, infections and BK virus viremia.~Arteriolar hyaline thickening is thickening of the walls of arterioles by the deposition of homogeneous pink hyaline material.~BPAR is biopsy proven acute rejection. TEM progression is the increase ≥ 1 of TEM score between Month 3 and Month 12"|M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Participants|||Number
1422125|NCT01079143|Secondary|Change in Interstitial Fibrosis/Tabular Atrophy (IF/TA) Grade|Difference (M12 - M3) in IF/TA grade. IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Number of Participants|||Number
1422126|NCT01079143|Secondary|Interstitial Fibrosis/Tabular Atrophy (IF/TA)|Incidence and severity of IF/TA according to 2005/2007 Banff classification system grades (grades l to lll). IF/TA grade was assessed during centralized reading according to the Banff 2005/2007 classification comprising grade I (<25%), grade II (25-50%) and grade III (>50% of lesions).|M3 and M12 post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12.|||Number of participants|||Number
1422140|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Content (BMC) at Month 24 Endpoint|BMC is an estimate of the amount of mineral (such as calcium) in the bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.|||percentage (%) change of grams (g)||Standard Error|Mean
1425746|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||Baseline|||||||
1422127|NCT01079143|Primary|Number of Participants With Progression of Renal Graft Fibrosis (Primary Comparison - ITT Population|"Progression of Interstitial Fibrosis/Tabular Atrophy (IF/TA) is the percentage (%) of participants with an increase >= 1 in IF/TA grade according to Banff (2005 - 2007)according to Epithelial-mesenchymal transition (EMT) profile and by treatment groups.~Grade I (the better): mild interstitial fibrosis and tubular atrophy (<25% of cortical area) Grade II : moderate interstitial fibrosis and tubular atrophy (26-50% of cortical area) Grade III (the worse) : severe interstitial fibrosis and tubular atrophy (>50% of cortical area)"|Month 3 (M3) and Month 12 (M12) post transplantation|ITT population: All patients randomized in the study who received at least one dose of the study treatment. Among the 194 participants in the ITT group, 58 patients in the EMT+ group completed the study providing a graft biopsy for analysis at M3 and M12. The primary comparison concerned only the Certican and the Neoral EMT+ groups.|||Participants|||Number
1422128|NCT01079130|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 2 (after 1 day of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure.|||Liters||Standard Error|Least Squares Mean
1422129|NCT01079130|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.|Day 15 (after 2 weeks of treatment)|Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1422130|NCT01078974|Primary|Tolerability of Pomalidomide|Number of participants with dose limiting toxicities which resulted in being removed from pomalidomide therapy|2 years||||participants|||Number
1422131|NCT01078974|Primary|Maximum Tolerated Dose of Pomalidomide|To determine the MTD of pomalidomide administered orally in patients with Waldenstrom's Macroglobulinemia in combination with dexamethasone and rituximab. Because maximum tolerated dose was not determined due to study termination, the highest dose of pomalidomide administered is presented below.|2 years|The maximum tolerated dose was not determined due to study termination. Three participants experienced IgM flare causing them to be removed from the study early.|||mg|||Number
1422132|NCT01078922|Secondary|Overall Clinical Benefit (OCB)|"OCB = # patients with a CR + # of patients with a PR + # patients with Stable Disease (SD) divided by the number of evaluable patients CR and PR is defined in Outcome Measure #1~SD is defined as:~Failure to attain CR/PR or Progressive Disease (PD)~PET remains positive.~PD is defined as:~Any new lesion > 1.5 cm in longest axis~An increase 50% or more of previously involved sites from nadir~50% increase in SPD of more than one node or 50% increase in the longest diameter of a previously identified node that is > 1 cm in shortest axis~PET remains positive if it was positive before therapy."|Evaluated every 2 cycles (every 2 months), up to 80 weeks||||percentage of participants|||Number
1422133|NCT01078922|Primary|Overall Response (OR)|"OR = # of patients with a Complete Response (CR) plus # of patients with a Partial Response (PR) divided by the total # of evaluable patients.~A CR is defined as:~Disappearance of all disease.~If nodal masses that Positron Emission Tomography (PET)- positive prior to therapy; they must be PET negative~If the nodal masses were Variably or PET negative; they must regress to normal.~No palpable liver or spleen~Palpable nodal masses are no longer palpable~Negative bone marrow biopsy~A PR is defined as:~Regression of measurable disease and no new sites of disease.~> 50% decrease in Sum of Product of Diameters (SPD) of up to 6 largest masses with no increase in the size of other nodes. If the nodal masses were PET positive prior to therapy then PET positive at previously involved sites is allowed. If they were Variably or PET negative then regression on CT is required.~No increase in the size of the liver or spleen"|evaluated every 2 months up to 80 weeks|Analysis was per protocol. Patients were evaluated every 2 cycles for Overall Response, up to 80 weeks.|||percentage of participants|||Number
1422134|NCT01078909|Secondary|Change in Lipid Mediators|0 Participants Analyzed; Lipid mediators were unable to be detected therefore there are no data to report.|1, 2, 3 and 5 days post LPS administration|Lipid mediators were unable to be detected; Data were not collected.||||||
1422135|NCT01078909|Primary|Mean Concentrations of CRP Following 5 Months of Treatment||5 months|One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%)|||mg/dL||95% Confidence Interval|Mean
1422136|NCT01078909|Primary|Mean Concentrations of Inflammatory Markers (TNF-alpha and IL-6) Following 5 Months of Treatment||5 months|One individual was removed from the analysis due to having very high RBC EPA+DHA content at study entry (>8%)|||pg/mL||95% Confidence Interval|Mean
1422137|NCT01078844|Primary|Clinical Global Impression-Scale(CGI-S)||12 weeks|This study was terminated prematurely and data was not collected for this outcome measure.||||||
1422138|NCT01078805|Secondary|Physician Criteria for Initiating FORTEO Therapy|Study investigators were provided a questionnaire that was populated with specific criteria they could choose from when they initiated Forteo therapy for their patients. They could have chosen more than one criteria, thus participants could have been counted multiple times. As this was actually a baseline characteristic rather than an outcome measure, data are presented in the baseline characteristic table rather than here.|Baseline|Participants are those who took at least one dose of study drug and had reasons documented to initiate Forteo therapy. This is a baseline characteristic; therefore data are presented in the section of Baseline Characteristics.|||participants|||Number
1422139|NCT01078805|Secondary|Percentage Change From Baseline in Bone Area at Month 24 Endpoint|Bone area is a defined region of interest of bone.|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.|||percent change of centimeter square||Standard Error|Mean
1425747|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale.||Baseline|||||||
1422141|NCT01078805|Secondary|Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint|A BMD test measures the amount of mineral (such as calcium) in a defined area of bone, grams per square centimeter (g/cm²).|Baseline, up to month 24|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase. At least one post-baseline measurement within 24 month, last observation carried forward.|||percentage (%) change of BMD||Standard Error|Mean
1422142|NCT01078805|Secondary|Treatment Adherence|Treatment adherence is the duration of time participants were on Forteo therapy during the 24-month treatment phase of the study.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.|||days||Standard Deviation|Mean
1422143|NCT01078805|Secondary|Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.|||percentage change of pain score||Standard Error|Mean
1422144|NCT01078805|Secondary|Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint|Visual analog pain scale is a measurement instrument to measure the level of pain. Scores range from 0 to 100. Higher score indicates greater pain. Mean percentage change is (Pain score at baseline visit - Pain score at Month 24)/Pain score at baseline visit*100%.|Baseline, Month 24|Participants with at least a VAS score of 40 at baseline and at least one post-baseline measurement.|||percentage change of pain score||Standard Error|Mean
1422145|NCT01078805|Secondary|Percentage of Participants With Clinical Vertebral Fractures|Clinical vertebral fracture was defined as a fracture that caused pain and/or discomfort, came to medical attention, and was confirmed by the investigator. Vertebral fracture sites included thoracic vertebra number 4 (T4) through lumbar spine vertebra number 4 (L4). Vertebral fracture is binary outcome (Yes/No). Percentage of participants= number of participants with new vertebral fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.|||Percentage of participants|||Number
1422146|NCT01078805|Primary|Percentage of Participants With Non-Vertebral Fragility Fractures|Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk * 100.|up to 24 months|Participants who received at least one dose of study drug and had non-missing start/stop date, and did not discontinue study drug more than 3 consecutive months at onetime during treatment phase.|||Percentage of participants|||Number
1422147|NCT01078753|Secondary|Change in Number of Wet Nights Between Treatment Periods I and II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Treatment Period I minus the number of wet nights during the 14-day Treatment Period II.|Treatment Period I (weeks 1-2) and Treatment Period II (weeks 3-4)|The full analysis set.|||wet nights||95% Confidence Interval|Least Squares Mean
1422148|NCT01078753|Secondary|Change in Number of Wet Nights Between Baseline and Treatment Period I|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period I.|Baseline (14-day period prior to starting study treatment) and Treatment Period I (weeks 1-2 after treatment initiation).|The Full analysis set.|||wet nights||95% Confidence Interval|Least Squares Mean
1422149|NCT01078753|Primary|Change in the Number of Wet Nights Between Baseline and Treatment Period II|The number of wet nights was recorded by participants (or their caregivers) in a daily diary. The difference was calculated from the number of wet nights during the 14-day Baseline Period minus the number of wet nights during the 14-day Treatment Period II.|Baseline (14-day period prior to starting study treatment) and Treatment Period II (weeks 3-4 after treatment initiation).|The Full Analysis Set (FAS) included all participants who received at least one dose of study treatment, satisfied all the major eligibility criteria and for whom efficacy data was obtained.|||wet nights||95% Confidence Interval|Least Squares Mean
1422150|NCT01078675|Secondary|Overal Treatment Adherence|Overall adherence rate was calculated as the weighted mean of adherence rates of all consecutive visits after baseline, in which the adherence rate between 2 consecutive visits was a percentage of the number of rosuvastatin taken divided by duration of exposure. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set|||Percent of doses||Standard Deviation|Mean
1422151|NCT01078675|Primary|Single Dose PK - AUC(0-24)|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set|||ng*hr/mL||Standard Deviation|Mean
1422152|NCT01078675|Primary|Single Dose PK - Tmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours|Single dose PK analysis set|||hr||Standard Deviation|Mean
1422153|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 24|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set|||Participants|||Number
1422154|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Month 12|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set|||Participants|||Number
1422156|NCT01078675|Secondary|Total Duration of Exposure|Total duration of exposure was calculated as [last dose date of rosuva - first dose date of rosuva + 1 day]. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set|||Days||Standard Deviation|Mean
1422157|NCT01078675|Secondary|Adverse Events|Number of participants with Various Categories of AE's. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|2-year study period|Safety analysis set|||Participant|||Number
1422158|NCT01078675|Secondary|Change From Baseline in Max and Mean Carotid Intima and Media Wall Thickness (cIMT)|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 12 and Month 24|Intent-to-treat analysis set (LOCF) and healthy siblings|||mm||Standard Deviation|Mean
1422159|NCT01078675|Secondary|Percent Change From Baseline in HDL-C, TC, TG, Non-HDL-C, LDL-C/HDL-C, TC/HDL-C, Non HDL C/HDL-C, ApoB, ApoA-1, and ApoB/ApoA-1|One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set (LOCF)|||Percent change||Standard Deviation|Mean
1422160|NCT01078675|Primary|Single Dose PK - Cmax|Serial plasma samples were taken at baseline (Week 0) at: 0.5 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours and on Day 1 at 24 hours after the single 10 mg dosing|Serial blood samples over 24 hours.|Single dose PK analysis set|||ng/mL||Standard Deviation|Mean
1422161|NCT01078675|Primary|Sexual Maturation by Tanner Staging at Baseline|Tanner stages (I-V) was used to characterize physical development in children and adolescent. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|At Baseline|Safety analysis set|||Participants|||Number
1422162|NCT01078675|Primary|Percent Change From Baseline in LDL-C|Negative values represent a decrease and positive values represent an increase. In total, 198 patients were treated. One patient received 1 dose of study drug but was not included in the efficacy and safety analyses due to a lack of follow-up data.|At Month 3, Month 12 and Month 24|Intent-to-treat analysis set and Per-protocol analysis set|||Percentage change||Standard Deviation|Mean
1422163|NCT01078662|Secondary|Disease Control Rate at Week 16|Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16|Full analysis set - all treated patients|||Percentage of participants||95% Confidence Interval|Number
1422164|NCT01078662|Secondary|Duration of Response|Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.|From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months|Full analysis set - all treated patients who had at least one complete or partial response during the assessment period.|||days||Inter-Quartile Range|Median
1422165|NCT01078662|Secondary|Overall Survival Rate at 12 Months|Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.|||Percentage of participants|||Number
1422166|NCT01078662|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.|||months||Inter-Quartile Range|Median
1422167|NCT01078662|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients. The Other cancer group was not analysed in accordance with the protocol.|||months||Inter-Quartile Range|Median
1422168|NCT01078662|Secondary|Objective Response Rate|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Measurable disease analysis set - all treated patients having at least one measurable lesion at baseline|||Percentage of participants||95% Confidence Interval|Number
1422169|NCT01078662|Primary|Tumour Response Rate|Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months|Full analysis set - all treated patients|||Percentage of participants||95% Confidence Interval|Number
1422170|NCT01078623|Secondary|Change From Baseline in Morning Peak FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1|||Liters||Standard Error|Least Squares Mean
1422171|NCT01078623|Secondary|Change From Baseline in Morning Pre-dose FEV1 at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes|Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1|||Liters||Standard Error|Least Squares Mean
1422172|NCT01078623|Primary|Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14|FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose|0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14|Intent to treat (ITT) population: all randomized patients who took at least 1 dose of study drug and had at least 1 baseline and 1 post-baseline assessment of value of FEV1|||Liters||Standard Error|Least Squares Mean
1422173|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline Versus After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) versus 12 months, using a 5-point Likert scale where participants responded to the question “Are you satisfied with your current hypertension therapy?”. The range of responses varied from “1 = not at all satisfied” to “5 = extremely satisfied.” Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|Subset of participants from the ITT cohort who answered the satisfaction questions at both the Baseline and 12-Month visits.|||percentage of participants|||Number
1422174|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 12 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|12 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).|||percentage of participants|||Number
1422175|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 6 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|6 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with blood pressure measurement at given time point).|||percentage of participants|||Number
1422176|NCT01078584|Other Pre-specified|Percentage of Diabetic and Renal Dysfunction Participants Achieving the Target of Blood Pressure (BP) <140/90 mm Hg at 3 Months|"Participants achieving the target of blood pressure <140/90 mm Hg were considered controlled."|3 Months|Evaluable participants (ITT participants in the Diabetic or Renal Dysfunction cohorts with BP measurement at given time point).|||percentage of participants|||Number
1422177|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication discontinued.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
1422178|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication discontinued.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
1422179|NCT01078584|Other Pre-specified|Number of Participants Discontinuing Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication discontinued.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
1422180|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 12 Months|Presented by type of medication added.|12 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
1422181|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 6 Months|Presented by type of medication added.|6 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
1422182|NCT01078584|Other Pre-specified|Number of Participants Adding Concomitant Cardiovascular Medications at 3 Months|Presented by type of medication added.|3 Months|Evaluable participants (all participants in the ITT cohort with available data at given time point).|||participants|||Number
1422183|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 12 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|12 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).|||percentage of participants|||Number
1422184|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 6 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|6 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).|||percentage of participants|||Number
1422185|NCT01078584|Other Pre-specified|Percentage of Diabetic and Non-diabetic (Blood Pressure [BP]-Controlled and BP-Uncontrolled) Participants With Dose Increases After 3 Months|"The percentage of non-diabetic and diabetic participants whose systolic and diastolic blood pressures were “controlled” versus “uncontrolled” was assessed using 2008 CHEP-specified targets (non-diabetics: BP <140/90 mm Hg; diabetics: BP <130/80 mm Hg). The percentage of these controlled and uncontrolled participants who underwent or did not undergo a dose increase is presented."|3 Months|Evaluable participants (diabetic and non-diabetic ITT participants with available data at given time point).|||percentage of participants|||Number
1422186|NCT01078584|Other Pre-specified|Number of Participants With Dose Changes at 12 Months||12 Months|Evaluable participants (all participants in the ITT cohort with data available at given time point).|||participants|||Number
1422189|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 12 Months|Compliance after 12 months of treatment was derived using responses to the question “How many trandolapril doses have been missed since the subject’s last visit?” at Visit 2, Visit 3 and Visit 4, as follows: if the response was “zero” at all of the Visits 2 through 4 assessments, the participant was classified as “compliant” after 12 months of treatment; if the response was any value greater than zero at any of the Visits 2 through 4 assessments, regardless of the number of missed doses, the participant was classified as “non-compliant” after 12 months of treatment.|12 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).|||participants|||Number
1422190|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 6 Months|Compliance after 6 months of treatment was derived using responses to the question “How many trandolapril (Mavik®) doses have been missed since the subject’s last visit?” at both Visit 2 and Visit 3, as follows: If the response was “zero” at both the Visit 2 and Visit 3 assessments, participant was classified as “compliant” after 6 months of treatment; If the response was any value greater than zero at either of the Visit 2 or Visit 3 assessments, regardless of the number of missed doses, participant was classified as “non-compliant” after 6 months of treatment|6 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).|||participants|||Number
1422191|NCT01078584|Other Pre-specified|Number of Participants Compliant With Therapy After 3 Months|Compliance after 3 months of treatment was derived using responses to the Visit 2 question “How many trandolapril (Mavik®) doses have been missed since the subject’s last visit?” If the response was “zero”, the participant was classified as “compliant.” If the response was any value greater than zero, regardless of the number of missed doses, the participant was classified as “non-compliant.”|3 Months|Evaluable participants (participants in the ITT cohort with compliance data available at given time point).|||participants|||Number
1422192|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 12||Day 0 (Baseline), Month 12|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
1422193|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 6||Day 0 (Baseline), Month 6|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
1422194|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts at Month 3||Day 0 (Baseline), Month 3|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
1422195|NCT01078584|Other Pre-specified|Mean Baseline Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Non-Diabetic, Diabetic, ISH, and Renal Dysfunction Cohorts||Day 0 (Baseline)|Evaluable participants (ITT participants in the non-diabetic, diabetic, ISH, and renal dysfunction cohorts with blood pressure measurement at timepoint).|||mm Hg||95% Confidence Interval|Mean
1422196|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 12 Months||Day 0 (Baseline), 12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given timepoint).|||mm Hg||95% Confidence Interval|Mean
1422197|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 6 Months||Day 0 (Baseline), 6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||mm Hg||95% Confidence Interval|Mean
1422198|NCT01078584|Other Pre-specified|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in ITT Cohort at 3 Months||Day 0 (Baseline), 3 Months|ITT cohort. n = all evaluable participants in the ITT cohort with blood pressure measurement at given timepoint.|||mm Hg||95% Confidence Interval|Mean
1422199|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 12 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|12 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
1422200|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 6 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|6 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
1422201|NCT01078584|Other Pre-specified|Percentage of Participants With Renal Dysfunction Achieving 2008 CHEP Targets After 3 Months of Therapy|"Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <130/80 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as controlled."|3 Months|Evaluable participants (ITT participants with renal dysfunction who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
1422202|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 12 Months of Therapy|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|12 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||percentage of participants|||Number
1423528|NCT01069341|Secondary|Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)|Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12|months 3, 7 and 12|All subjects' data was analyzed, no subjects were excluded|||participants|||Number
1422203|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 6 Months of Therapy|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|6 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||percentage of participants|||Number
1422204|NCT01078584|Other Pre-specified|Percentage of Participants Achieving 2008 CHEP Targets After 3 Months of Therapy|Blood Pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg. Where a participant had both an SBP and DBP less than the target, the participant's BP was defined as “controlled.”|3 Months|Evaluable participants (participants in the ITT cohort with blood pressure measurements at given time point).|||percentage of participants|||Number
1422205|NCT01078584|Secondary|Percentage of Participants Reporting Defined Levels of Satisfaction With Current Therapy at Baseline and After 12 Months of Therapy|"Satisfaction with therapy at baseline (BL) and 12 months, using a 5-point Likert scale where participants responded to the question Are you satisfied with your current hypertension therapy?. The range of responses varied from 1 = not at all satisfied to 5 = extremely satisfied. Responses 2 through 4 were not otherwise defined, but represented increments of more or less satisfaction with current therapy, respectively."|Day 0 (Baseline), 12 months|ITT cohort. n=evaluable participants from the ITT cohort who answered the satisfaction questions at Baseline and 12-Month visits.|||percentage of participants|||Number
1422206|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 12 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|12 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
1422207|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 6 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|6 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
1422208|NCT01078584|Secondary|Percentage of Participants With Isolated Systolic Hypertension (ISH) Reaching 2008 CHEP Systolic Blood Pressure (BP) Target After 3 Months of Therapy|The 2008 CHEP systolic BP (SBP) target is <140 mm Hg. Where a participant had an SBP less than the target, the participant's SBP was defined as “controlled.”|3 Months|Evaluable participants (ITT participants with ISH who had blood pressure measurements at given timepoint).|||percentage of participants|||Number
1422209|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 12 Months||Baseline, 12 months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).|||mg/L||95% Confidence Interval|Mean
1422210|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 6 Months||Baseline, 6 Months|Evaluable Participants (all participants in the ITT cohort with MAU measurement at given time point).|||mg/L||95% Confidence Interval|Mean
1422211|NCT01078584|Secondary|Change From Baseline in Microalbuminuria (MAU) at 3 Months||Baseline, 3 Months|Evaluable participants (all participants in the ITT cohort with MAU measurement at given time point).|||mg/L||95% Confidence Interval|Mean
1422212|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 12 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline,12 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).|||mL/min||95% Confidence Interval|Mean
1422213|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 6 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 6 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).|||mL/min||95% Confidence Interval|Mean
1422214|NCT01078584|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) in Blood Pressure (BP)-Controlled and BP-Uncontrolled Diabetics at 3 Months|"Diabetics were considered to be BP-controlled if BP <130/80 mm Hg. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg."|Baseline, 3 Months|Evaluable participants (diabetic ITT participants with eGFR measurement at given time point).|||mL/min||95% Confidence Interval|Mean
1422215|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 12 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|12 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).|||percentage of participants|||Number
1422216|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 6 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|6 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).|||percentage of participants|||Number
1422217|NCT01078584|Primary|Percentage of Non-Diabetic and Diabetic Participants Meeting Blood Pressure Targets at 3 Months|Blood pressure (BP) targets, as specified in the 2008 CHEP recommendations, were systolic BP (SBP)/diastolic BP (DBP) <140/90 mm Hg for non-diabetic participants, and SBP/DBP <130/80 mm Hg for diabetic participants.|3 months|Evaluable participants (diabetic and non-diabetic ITT participants with blood pressure measurement at given time point).|||percentage of participants|||Number
1422309|NCT01078155|Primary|Bone Mineral Density (BMD) of Spine and Hip by Dual-energy X-ray Absorptiometry (DEXA) at Baseline, Month 12, and Month 24|BMD of spine and hip (L1-L4 and proximal femur) by DEXA, evaluated according to standard clinical guidelines.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||g/cm^2||Standard Deviation|Mean
1422218|NCT01078571|Secondary|Radiological Evaluation of Rheumatoid Arthritis (RA).|Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.|Baseline and 12 months|This analysis was conducted in the intent-to-treat population (591 participants total).|||Participant|||Number
1422219|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.|Baseline and 12 Months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.|||Percentage change||Standard Deviation|Mean
1422220|NCT01078571|Secondary|Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.|Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: <1 = no/mild disability, 1 to 2 = moderate disability, and >2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).|Baseline and 12 months|The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.|||Units on a scale||Standard Deviation|Mean
1422221|NCT01078571|Secondary|Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.|The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.|Baseline, 1, 4, 6, and 12 months|This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.|||Joints||Standard Deviation|Mean
1422222|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The percentage reduction of baseline values is presented."|Baseline and 12 months|Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.|||Percentage reduction||Standard Deviation|Mean
1422223|NCT01078571|Secondary|Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).|"The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (<= 2.6), Low Disease Activity (>2.6 to <=3.2), Moderate Disease Activity (>3.2 to <= 5.1) and High Disease Activity (>5.1). The mean change in DAS 28 score from baseline to final is presented."|Baseline and 12 months|Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.|||Units on a scale||Standard Deviation|Mean
1422224|NCT01078571|Primary|Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment|The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.|Baseline, 1, 4, 6, and 12 months|This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).|||Participants|||Number
1422225|NCT01078545|Secondary|Reported Adverse Events/Serious Adverse Events|Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.|||Participants|||Number
1422226|NCT01078545|Secondary|Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.|Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.|||Units on a scale||Full Range|Median
1437341|NCT00955487|Secondary|Necrotizing Enterocolitis (NEC)|Number of participants diagnosed with necrotizing enterocolitis|After randomization through hospital discharge||||Participants|||Count of Participants
1422227|NCT01078545|Secondary|Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.|Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.|Baseline|Analysis conducted in the intent-to-treat population.|||Percentage of participants|||Number
1422228|NCT01078545|Secondary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 3, 6, 9, and 12 months.|Analysis conducted in the intent-to-treat population.|||units on a scale||Standard Deviation|Mean
1422229|NCT01078545|Primary|The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.|The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|Baseline to 12 months|Analysis conducted in the intent-to-treat population.|||units on a scale||Standard Deviation|Mean
1422230|NCT01078454|Primary|Proportion of Patients With Hematologic Overall Response (Partial Response [PR]+ Very Good PR [VGPR]+ Amyloid Complete Response [ACR]+ Stringent Complete Response [sCR]) After 3 Months (3 Cycles) of Therapy|sCR: ACR and no clonal cells in bone marrow (BM) ACR: Negative serum/urine immunofixation (IF), <5% plasma cells in BM, and normal serum FLC ratio VGPR: 1. PR and any of the following; 2. serum/urine M-protein detectable by IF but not measurable (NM) on electrophoresis (EP); (3) ≥90% reduction in serum M-component and urine M-protein <100 mg/24 hr if baseline serum measurable; (4) urine M-component <100 mg/24 hr and NM serum M-protein on serum protein EP if baseline urine measurable; (5) ≥90% drop in the difference between involved and uninvolved FLC levels if only FLC measurable PR: (1) ≥50% drop of serum M-protein and 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline serum/urine measurable; or (2) ≥50% drop of serum M-protein if only serum measurable at baseline; or (3) 24-hr urinary M-protein drop by ≥90% or to <200 mg/24 hr if baseline urine measurable; or (4) ≥ 50% drop in the difference between involved and uninvolved FLC if only FLC measu|Assessed at 3 months|All enrolled patients are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
1422231|NCT01078441|Primary|One-year Survival in Patients Treated With This Regimen.|Proportion of patients who are still alive at 1 year after registration.|Assessed at 1 year|All eligible and treated patients are included in this analysis.|||Proportion of patients||90% Confidence Interval|Number
1422232|NCT01078402|Secondary|Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.|From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||participants|||Number
1422233|NCT01078402|Secondary|Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy|Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.|From first treatment until study discontinuation, up to 13 months.|Participants in the SES who discontinued therapy and had evaluable records. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||weeks||Standard Deviation|Mean
1422234|NCT01078402|Secondary|Compliance With the Humira Administration Schedule at Month 13 (End of Study)|Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.|Month 13|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||participants|||Number
1422235|NCT01078402|Secondary|Participant Acceptability of Self-injection at Month 13 (End of Study)|Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator’s opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.|13 months|Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.|||percentage of participants|||Number
1422261|NCT01078363|Secondary|Index of Microcirculatory Resistance at One Year Post Heart Transplant|The index of microcirculatory resistance (IMR) is a pressure-temperature sensor guidewire-based measurement, performed during cardiac catheterization, of the minimum microcirculatory resistance in a specific coronary artery. The IMR provides a quantitative measure of coronary microvasculature status.|one year|Only a subset of participants (adult patients enrolled at Stanford University) underwent index of microcirculatory resistance assessment.|||mmHg x seconds||Standard Deviation|Mean
1434156|NCT00979459|Secondary|Number of Participants Who Experienced at Least One Adverse Event||Through 30 days post-dose|All participants received both formulations of MK-1006, FCT and DFC, and appear in both treatment groups.|||participants|||Number
1422236|NCT01078402|Secondary|Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy|HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.|Baseline, 4, 7 and 13 months|SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented. n=number of participants with evaluable records at given time point.|||units on a scale||Standard Deviation|Mean
1422237|NCT01078402|Primary|Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS|BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.|||participants|||Number
1422238|NCT01078402|Primary|Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA|DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.|Baseline, 3 months|Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.|||participants|||Number
1422239|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of the single affected joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) and Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst). The Erosion Score and the JSN Score were summed for the Total Score. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
1422240|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Rheumatoid Arthritis MRI Scoring System (RAMRIS) Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Magnetic Resonance Imaging (MRI) was evaluated using the Rheumatoid Arthritis MRI Score (RAMRIS). Bone erosion in the proximal and distal location were each assessed in the affected joint using an 11-point scale where 0=no erosion (best) to 10=91-100% bone eroded (worst) for a bone erosion score range of 0 to 20. Bone marrow edema in the proximal and distal location were each assessed using a 4-point scale where 0=no edema (best) to 3=67-100% edema (worst) for a bone marrow edema (BME) score range of 0 to 6. Synovitis was assessed in the affected joint using a 4-point scale where 0=normal (best) to 3=severe (worst). Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
1422241|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
1422242|NCT01078389|Secondary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Total Scores From Full Hands and Feet Radiographs|Radiographs (X-rays) of 40 joints in the hands and 12 joints in the feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst) for a total erosion score range of 0 to 320. Joint space narrowing (JSN) was assessed using a 5-point scale where 0=normal (best) to 4=absence of joint space, presumptive evidence of ankyloses, or complete luxation (worst) for a total JSN score range of 0 to 208. The Erosion Score and the JSN Score were combined for a total possible score of 0 to 528. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available at Baseline and Month 24 are included in the analysis.|||score on a scale||Standard Deviation|Mean
1422243|NCT01078389|Primary|Mean Change From Baseline to Month 24 in the Modified Sharp/Van Der Heijde Erosion Score of the Single Affected Joint|The single affected joint was defined as the joint with the history of the first acute gout flare. Radiographs (X-rays) of this single joint in the hands or feet were evaluated using the modified Sharp/van der Heijde method. Each erosion was assessed using a 4-point scale where 0=no erosions (best) to 3=large erosion passing the mid-line (worst). Individual erosion scores were summed to a maximum erosion score of 5 for joints in the hands and 10 for joints in the feet. Higher scores indicated more joint damage. A negative change from Baseline indicated improvement.|Baseline and Month 24|Full Analysis Set included all randomized participants who received at least one dose of study medication. Participants were analyzed according to the treatment group to which they actually received. Participants with data available for analysis and missing values at Month 24 imputed using linear extrapolation are included in the analysis.|||score on a scale||Standard Deviation|Mean
1422244|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||L/hr||Standard Deviation|Mean
1422245|NCT01078376|Primary|Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||L/hr||Standard Deviation|Mean
1422246|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||percent||Standard Deviation|Mean
1422247|NCT01078376|Primary|Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)|Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||percent||Standard Deviation|Mean
1422248|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||mg||Standard Deviation|Mean
1422249|NCT01078376|Primary|Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)||Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||mg||Standard Deviation|Mean
1422250|NCT01078376|Primary|Apparent Oral Clearance (CL/F) for TAK-536|CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||L/hr||Standard Deviation|Mean
1422251|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Standard Deviation|Mean
1422252|NCT01078376|Primary|Terminal Elimination Half-life (T1/2) for TAK-536|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Standard Deviation|Mean
1422253|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Full Range|Median
1422254|NCT01078376|Primary|Time to Reach Cmax (Tmax) for TAK-536|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||hr||Full Range|Median
1422255|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng/mL||Standard Deviation|Mean
1422256|NCT01078376|Primary|Maximum Observed Plasma Concentration (Cmax) for TAK-536|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng/mL||Standard Deviation|Mean
1422257|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
1422258|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536|Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
1422259|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
1422260|NCT01078376|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Pharmacokinetic Set; Results are presented by individual dose for Cohorts 1 and 2.|||ng.hr/mL||Standard Deviation|Mean
1422842|NCT01074658|Primary|Major Adverse Cardiac & Cerebrovascular Events (MACCE)|"MACCE is defined as a composite of:~All cause mortality~Myocardial Infarction (Q-wave and non-Q-wave)~Emergent cardiac surgery or percutaneous re-intervention~Stroke~The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days."|30 days|All attempted population.|||Freedom from MACCE (%) @30days|||Number
1422262|NCT01078363|Secondary|Fractional Flow Reserve (FFR) at One Year Post Transplant|FFR is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia). It is defined as the ratio of the distal coronary pressure to the proximal coronary pressure.|at one year post Transplant|Only a subset of participants (adult patients enrolled at Stanford University) underwent fractional flow reserve assessment.|||Ratio||Standard Deviation|Mean
1422263|NCT01078363|Secondary|The Percentage of Endothelial Progenitor Cells ( EPC) in Peripheral Blood in Patients One Year After Transplant|The determination of the percentage of EPC in peripheral blood involved surface staining peripheral blood mononuclear cells (PBMCs) with appropriate fluorescently-labeled antibodies to delineate EPCs from other blood cells, followed by analysis by conventional flow cytometry.|at one year|Not all blood samples obtained were adequate for EPC determination which explains the discrepancy in number of participants analyzed.|||percentage of EPC||Standard Deviation|Mean
1422264|NCT01078363|Secondary|ADMA Level at One Year Post Transplant|asymmetric dimethylarginine (ADMA), is an inhibitor of endothelial nitric oxide synthase which is a primary regulator of endothelial function.|1 year post Transplant|Blood samples were not acquired in all participants which accounts for the discrepancy in number of participants analyzed.|||micromole||Standard Deviation|Mean
1422265|NCT01078363|Secondary|Percentage of Participants With ≥20% Coronary Artery Diameter Reduction After Acetylcholine|The percent change in diameter of the left anterior descending artery was measured by quantitative angiography after acetylcholine and compared to baseline angiography. The percentage of participants who had ≥20% coronary artery diameter reduction after acetylcholine at one year is presented.|At Baseline and 1 Year|Only a subset of participants (those adult patients enrolled at Stanford University) underwent the acetylcholine measurements.|||percentage of participants|||Number
1422266|NCT01078363|Primary|Cardiac Allograft Vasculopathy(CAV) Defined as Change in IVUS-assessed Plaque Volume From Baseline to One Year|also called transplant coronary artery disease or cardiac transplant vasculopathy defined as coronary artery stenosis(narrowing) ranging from 30 to 70 percent by coronary angiography. Measured in this study as change in IVUS-assessed Plaque Volume from baseline to one year.|Baseline and 1 Year||||mm3/mm||Standard Deviation|Mean
1422267|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior (3)(“Yes” on “preparatory acts or behavior”), suicidal ideation (4)(“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(“Yes” on “Has participant engaged in non-suicidal self-injurious behavior”).|Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.|||participants|||Number
1422268|NCT01078298|Other Pre-specified|Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score|The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||Units on a scale||Standard Deviation|Mean
1422269|NCT01078298|Other Pre-specified|Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||Units on a scale||Standard Deviation|Mean
1422270|NCT01078298|Other Pre-specified|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. 'n' is signifying those participants who were evaluated for this measure at the satisfaction level for each group respectively.|||Units on a scale||Standard Deviation|Mean
1422271|NCT01078298|Other Pre-specified|Number of Participants With Clinical Global Impression - Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected|Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specific categories for each arm group.|||participants|||Number
1422293|NCT01078220|Primary|Incidence Rate of Syncope|Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a “rule out” diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.|On day of each vaccination||||Rate per 1000 person years|||Number
1422272|NCT01078298|Other Pre-specified|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52|Safety analysis population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is signifying those participants who were evaluated for this measure at the time point for each group respectively.|||participants|||Number
1422273|NCT01078298|Other Pre-specified|Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)|Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.|Baseline up to Week 16|Safety analysis population included all participants who took at least 1 dose of randomized study medication, including partial doses, and had a safety measurement.|||participants|||Number
1422274|NCT01078298|Secondary|Number of Participants With 4-Week Point Prevalence (PP) of Abstinence|Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||participants|||Number
1422275|NCT01078298|Secondary|Number of Participants With 7-day Point Prevalence (PP) of Abstinence|Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Weeks 12, 24, 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||participants|||Number
1422276|NCT01078298|Secondary|Percentage of Participants With Continuous Abstinence Rate (CAR)|Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.|Week 9 through Week 24, Week 9 through Week 52|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||Percentage of participants|||Number
1422277|NCT01078298|Primary|Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)|"Percentage of participants who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) questions: ‘Has the participant smoked cigarettes’ and ‘Has the participant used other nicotine-containing products’ in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm)."|Week 9 through Week 12|All participants analysis set included all the participants who were randomized and took at least one dose of randomized study medication.|||Percentage of participants|||Number
1422278|NCT01078246|Secondary|Incidence of All-cause Mortality|All-cause mortality occurring during the risk period was identified through the use of computer-stored records of Emergency Department visits, hospitalizations, and state death certificates. Deaths were identified from administrative Kaiser Permanente databases, including Kaiser Permanente regional research and respective state(s) mortality files as well as the Social Security Administrative files. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
1422279|NCT01078246|Secondary|Incidence of Clinically Important Cardiovascular Events|Significant cardiovascular events occurring during the risk period were identified through the use of computer-stored records and defined as inpatient events based on algorithms that utilize a combination of diagnosis and/or procedure codes. The identification of potential significant cardiovascular events was based on the occurrence of major adverse cardiovascular events (MACE) which include acute myocardial infarction (MI), ischemic stroke, unstable angina, revascularization (e.g. percutaneous coronary intervention (PCI) and coronary bypass graft surgery (CABG)), and cardiovascular death. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
1422280|NCT01078246|Primary|Incidence of Lipodystrophy|Lipodystrophy (e.g. lipoatrophy, facial wasting) occurring during the risk period was identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential lipodystrophy was based on two coded diagnoses codes indicative of lipodystrophy appearing at least 6 months apart over the course of patient care, the identification of interventions to treat such conditions (e.g. sculptra therapy), or procedural codes for Computerized Tomography indicating incident neck or abdominal lipoaccumulation. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
1422281|NCT01078246|Primary|Incidence of Clinically Important Muscle Events|Significant muscle events (e.g. rhabdomyolysis) occurring during the risk period were identified through the use of computer-stored records of laboratory values, outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant muscle events was based on algorithms utilizing a combination of diagnoses, procedures and/or laboratory results for creatinine kinase. The number of muscle events did not meet the threshold for statistical analysis per protocol. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
1422282|NCT01078246|Primary|Incidence of Clinically Important Skin Events|Significant skin events (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis) occurring during the risk period were identified through the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations. The identification of potential significant skin events was based on algorithms utilizing a combination of diagnoses, procedures and/or medications. Surveillance of outpatient visits was limited to rashes coded as drug-related and requiring use of steroid (e.g. prednisone) administration. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
1422283|NCT01078246|Primary|Incidence of Clinically Important Hepatic Events|Hepatic events occurring during the risk period were identified through computer-stored records of laboratory values, outpatient visits, Emergency Department visits, and hospitalizations. Significant hepatic events were identified based on algorithms utilizing a combination of diagnoses, procedures, and laboratory results. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
1422284|NCT01078246|Primary|Incidence of AIDS-defining and Non-AIDS-defining Malignancy|All new malignancies occurring during the risk period, including Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancies, were identified through the Kaiser Permanente cancer registries. The registry data was supplemented by the use of computer-stored records of outpatient visits, Emergency Department visits and hospitalizations to identify cancers that would not be captured through the cancer registries (e.g. cutaneous Kaposi’s sarcoma).The AIDS-defining malignancies reported for any cohort were invasive cervical cancer, Kaposi's sarcoma, and non-Hodgkin lymphoma. Incidence is reported as unadjusted, crude rates.|Historical Cohort: up to 33 months (January 2005 to October 2007); Raltegravir and Concurrent Cohorts: up to 69 months (October 2007 to June 2013)|The analysis includes all eligible participants.|||Events per 1000 person-years of followup||95% Confidence Interval|Number
1422285|NCT01078233|Primary|Incidence of All-Cause Mortality|All participant deaths were recorded|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
1422286|NCT01078233|Primary|Incidence of Lipodystrophy|Lipodystrophy events were defined as the first report for either 1) loss of fat from extremities, buttocks, or face, or 2) accumulation of fat in abdomen, neck, breasts, or other defined location.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
1422287|NCT01078233|Primary|Incidence of Clinically Important Hepatic Events|Clinically important hepatic events were defined as either 1) hepatic encephalopathy (stage III or IV), or 2) discontinuation of raltegravir use where liver toxicity was listed as the reason for discontinuation.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
1422288|NCT01078233|Primary|Incidence of Malignancy|All-type malignancy, including both Acquired Immune Deficiency Syndrome (AIDS)-defining and non-AIDS-defining malignancy, was evaluated. Only the first occurrence of any malignancy type was counted for each participant.|Historical Cohort: up to 24 months (January 2006 to December 2007); Raltegravir and Concurrent Cohorts: up to 68 months (December 2007 to July 2013)|Intention-to-Treat analysis included follow-up until the end of the follow-up period for the cohort, regardless of whether or not raltegravir or other drugs were discontinued.|||Events per 100 person-years of follow-up|Person years of follow-up|95% Confidence Interval|Number
1422289|NCT01078220|Primary|Incidence Rate of Cellulitis|Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a “rule out” diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.|Within 14 days and within 60 days immediately after each vaccination||||Rate per 1000 person years|||Number
1422290|NCT01078220|Secondary|Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil|"Autoimmune cases were defined as newly diagnosed cases within 6 months after any~dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest."|within 6 months immediately after each vaccination|Number of females with at least 12 months' membership at a MCO prior to Gardasil.|||Number of autoimmune cases|||Number
1422291|NCT01078220|Secondary|Number of Miscarriages Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to pregnancy resolution|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.|||Number of miscarriages|||Number
1422292|NCT01078220|Secondary|Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy|Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.|First dose of Gardasil in pregnancy up to 6 months after birth|Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.|||Number of congenital anomalies|||Number
1437722|NCT00951912|Primary|Percentage Change in High Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months||||Percentage of change||Standard Deviation|Mean
1422294|NCT01078207|Secondary|Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure.|The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors.|12 hours after discharge form the recovery room|All patients with a positive repetitive reduction in nasal airflow.|||participants|||Number
1422295|NCT01078207|Primary|Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data.|Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects|12 hour after released from the recovery room|All patients with complete data were analyzed.|||participants|||Number
1422296|NCT01078168|Primary|Difference in Cerebrospinal Fluid (CSF) Soluble Alpha-clevaed Amyloid Precursor Protein (APPsα) Concentration at Visit 3 Compared to Baseline|Values were assessed via Western blotting technique. Normalization was conducted using hSA levels of the individual samples.|baseline and 4 weeks (visit 3)|All patients were included with successful punctation at V1 and V3. For one Acitretin-treated patient not punctation at V3 was obtained (resulting n of 10).|||fold change (Visit 3/background)||Standard Deviation|Mean
1422297|NCT01078155|Secondary|Erythrocyte Sedimentation Rate (ESR) at Baseline, Month 3, Month 12, Month 24|ESR was recorded as per local clinical practice. Normal findings are up to 20 mm/hr for females and up to 15 mm/hr for males.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||mm/1 hour||Standard Deviation|Mean
1422298|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject’s Assessment of Pain at Baseline, Month 3, Month 12, Month 24|Subject’s Assessment of Pain VAS was reported on a 100 mm scale, where 0 = no pain through 100 = severe pain.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||units on a scale||Standard Deviation|Mean
1422299|NCT01078155|Secondary|Visual Analogue Scale (VAS): Subject’s Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Subject’s Global Assessment of Disease Activity VAS was reported on a 100 mm scale, reporting the subject's evaluation of his/her difficulties as 0 = without any difficulty to 100 = significant difficulties.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||units on a scale||Standard Deviation|Mean
1422300|NCT01078155|Primary|Tender Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of tender joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||joints||Standard Deviation|Mean
1422301|NCT01078155|Primary|Mean Duration of Morning Stiffness at Baseline, Month 3, Month 12, and Month 24|"Participant-reported the existence and duration of morning stiffness, defined as morning stiffness in and around the joints, lasting at least 1 hour before maximal improvement."|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||minutes||Standard Deviation|Mean
1422302|NCT01078155|Primary|Change in Bone Turnover Marker C-telopeptide of Type I Collagen (CTX-I) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.|||µg/L||Standard Deviation|Mean
1422303|NCT01078155|Secondary|Visual Analogue Scale (VAS): Physician’s Global Assessment of Disease Activity at Baseline, Month 3, Month 12, Month 24|Physician’s Global Assessment of Disease Activity VAS was reported on a 100 mm scale, where 0 = very good to 100 = very bad.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit, with evaluable data at time points.|||units on a scale||Standard Deviation|Mean
1422304|NCT01078155|Secondary|Disease Activity Score in 28 Joints (DAS28) at Baseline, Month 3, Month 12, Month 24|Scores on the DAS28 range from 0 to 10. DAS 28 ≥ 5.1= high RA disease activity; DAS 28 ≥ 3.2 = middle RA disease activity; DAS 28 ≤ 3.2 = lower disease activity; DAS 28 ≤ 2.6 = remission of disease.|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||units on a scale||Standard Deviation|Mean
1422305|NCT01078155|Secondary|Swollen Joint Count at Baseline, Month 3, Month 12, and Month 24|The investigator counted the number of swollen joints at each study visit (28 joints are routinely examined).|Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||joints||Standard Deviation|Mean
1422306|NCT01078155|Primary|Change in Bone Turnover Marker C-terminal Type I Procollagen Peptide (CICP) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.|||ng/mL||Standard Deviation|Mean
1422307|NCT01078155|Primary|Change in Bone Turnover Marker Osteocalcin (OC) From Baseline Through Month 3, Month 12, and Month 24||Baseline (Day 0), Month 3, Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with bone turnover markers at time point.|||µg/L||Standard Deviation|Mean
1422308|NCT01078155|Primary|Spine and Hip T-score and Z-score by DEXA at Baseline, Month 12, and Month 24|T-score and Z-score of spine and hip (L1-L4 and proximal femur) by DEXA. T-score is the number of standard deviations that bone density is above or below the average. A score of ≥ -1 = normal bone density; < -1 and > -2.5 = a sign of osteopenia (bone density below normal); ≤ -2.5 = a sign of osteoporosis. Z-score is the number of standard deviations above or below what's normally expected for someone of matching age, sex, weight, and ethnic or racial origin. A Z-score ≤ -2 may suggest abnormal bone loss due to conditions other than aging.|Baseline (Day 0), Month 12, Month 24|Per-Protocol Set: all participants who participated in every study visit; n=participants with evaluable data at time point.|||standard deviations||Standard Deviation|Mean
1423529|NCT01069341|Primary|Adverse Event (AE)|Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).|first 12 months|All subjects' data was analyzed, no subjects were excluded|||participants|||Number
1422310|NCT01078116|Primary|Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)|The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years [QALYs]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).|12 months|Cost-utility analysis is based on the 76 participants who completed the study through 12 months.|||Euros|||Number
1422311|NCT01078116|Primary|Health Related Quality of Life (Medical Outcome Study Short Form 36)|Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.|||Units on a scale||Standard Deviation|Mean
1422312|NCT01078116|Primary|Health Related Quality of Life (Health Assessment Questionnaire)|Health Assessment Questionnaire (HAQ) is designed to assess patients’ abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessment at each time point.|||units on a scale||Standard Deviation|Mean
1422313|NCT01078116|Primary|Health Related Quality of Life (European Quality of Life 5 Dimensions)|European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.|||Units on a scale||Standard Deviation|Mean
1422314|NCT01078116|Primary|Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment|Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.|Enrollment visit (Baseline), month 3, month 6, month 12|Analysis is based on the number of participants completing the assessments at each visit.|||Euros||Standard Deviation|Mean
1422315|NCT01078090|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1422316|NCT01078090|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)|||percentage of participants|||Number
1422317|NCT01078090|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months due to rheumatoid arthritis. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set participants who were employed and with available data at each time point (indicated by n)|||days||Standard Deviation|Mean
1422318|NCT01078090|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 6, 18, 24, and 30|Full analysis set (FAS) participants with available data at each time point.|||percentage of participants|||Number
1422319|NCT01078090|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||cm||Standard Deviation|Mean
1422320|NCT01078090|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||cm||Standard Deviation|Mean
1422321|NCT01078090|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||cm||Standard Deviation|Mean
1422322|NCT01078090|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula: FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0% indicates maximal impairment and 100% indicates maximal functional capacity.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
1422323|NCT01078090|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||swollen joints||Standard Deviation|Mean
1422324|NCT01078090|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||tender joints||Standard Deviation|Mean
1422325|NCT01078090|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||mg/L||Standard Deviation|Mean
1422326|NCT01078090|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||mm/hour||Standard Deviation|Mean
1422327|NCT01078090|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1.~The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|Full analysis set (FAS) participants with available data at each time point.|||percentage of participants|||Number
1422328|NCT01078090|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.~The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1422329|NCT01078090|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a DAS28 score of < 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale [VAS] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1422330|NCT01078090|Primary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.~A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
1422331|NCT01077973|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
1422332|NCT01077973|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.|||Percentage of participants|||Number
1422333|NCT01077973|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.|0 to 3 hours|Data was not analyzed as there were no treatment failures observed and no participant received rescue medication in the study.|||Minutes||95% Confidence Interval|Median
1422364|NCT01077921|Primary|SS RBC Adhesion (Epi -1d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 1 dyne/cm2|Week 0 to 6 and week 8 to 14||||Percentage of total RBC||Standard Deviation|Mean
1422334|NCT01077973|Secondary|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
1422335|NCT01077973|Secondary|Cumulative Percentage of Participants With Meaningful Relief|Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Percentage of participants|||Number
1422336|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1422337|NCT01077973|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1422338|NCT01077973|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1422339|NCT01077973|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1422340|NCT01077973|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1422341|NCT01077973|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1422342|NCT01077973|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
1422343|NCT01077973|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
1422344|NCT01077973|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled ‘meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated “meaningful relief” at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
1422345|NCT01077973|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 3 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||Units on a scale||Standard Deviation|Mean
1422346|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||mg/dL||Standard Deviation|Mean
1422347|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in 120 Minute Glucose|Oral glucose testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||mg/dL||Standard Deviation|Mean
1422348|NCT01077960|Secondary|Oral Glucose Tolerance Testing - Change From Baseline to Week 12 in Fasting Insulin|Oral glucose tolerance testing|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||mcIU/mL||Standard Deviation|Mean
1422349|NCT01077960|Secondary|Change From Baseline to Week 12 in Insulin-like Growth Factor I|Circulating levels of IGF-I|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||ng/mL||Standard Deviation|Mean
1422350|NCT01077960|Secondary|Change From Baseline to Week 12 in Waist Circumference|Measured by anthropometry|baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||cm||Standard Deviation|Mean
1422351|NCT01077960|Primary|Change From Baseline to Week 12 in Trunk Fat as Assessed by Dual-Energy X-Ray Absorptiometry (DXA) Scan||baseline to 12 weeks|The analysis population reported here comprised the subjects who received at least one dose of study drug|||kg||Standard Deviation|Mean
1422352|NCT01077921|Secondary|Overall Change of Diastolic Blood Pressure Levels|Overall change of Diastolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||mmHg||Inter-Quartile Range|Median
1422353|NCT01077921|Secondary|Overall Change of Systolic Blood Pressure Levels|Overall change of Systolic Blood Pressure levels from baseline to post intervention (Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||mmHg||Inter-Quartile Range|Median
1422354|NCT01077921|Secondary|Overall Change of Oxygen Saturation (02Sat) Levels|Overall change of Oxygen Saturation (02Sat) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||percentage of oxygen saturation||Inter-Quartile Range|Median
1422355|NCT01077921|Secondary|Overall Change of Lactate Dehydrogenase (LDH) Levels|Overall change of LDH levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||IU/L||Inter-Quartile Range|Median
1422356|NCT01077921|Secondary|Overall Change of Hematocrit (Hct) Levels|Overall change of Hematocrit (Hct) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||percentage of red blood cells||Inter-Quartile Range|Median
1422357|NCT01077921|Secondary|Overall Change of Hemoglobin (Hgb) Levels|Overall change of Hemoglobin (Hgb) levels from baseline to post intervention( Week 0 to 6 and week 8 to 14) Placebo vs. Propranolol treated|Week 0 to 6 and week 8 to 14||||gm/dL||Inter-Quartile Range|Median
1422358|NCT01077921|Secondary|Overall Change of Plasma Levels of sVCAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sVCAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 or week 8 to 14)|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
1422359|NCT01077921|Secondary|Overall Change of Plasma Levels of sICAM-1|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sICAM-1 measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14)|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
1422360|NCT01077921|Secondary|Overall Change of Plasma Levels of sP-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sP-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and weeks 8 to 14).|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
1422361|NCT01077921|Primary|SS RBC Adhesion (Epi -3d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 3 dyne/cm2|Week 0 to 6 and week 8 to 14||||Percentage of total RBC||Standard Deviation|Mean
1422362|NCT01077921|Primary|SS RBC Adhesion (Epi -2d/cm2- vs. Sham) by Treatment|The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 2 dyne/cm2|Week 0 to 6 and week 8 to 14||||Percentage of total RBC||Standard Deviation|Mean
1422363|NCT01077921|Secondary|Overall Change of Plasma Levels of sE-selectin|Biomarkers of Endothelial Activation and Dysfunction: Overall change of Plasma levels of sE-selectin measured in triplicate on plasma samples using commercially available ELISA kits from baseline to post intervention ( Week 0 to 6 and week 8 to 14).|Week 0 to 6 and week 8 to 14||||ng/ml||Standard Deviation|Mean
1423130|NCT01072344|Secondary|Frequency of Early Study Discontinuation in Each Treatment Condition.|This is the # of subjects who discontinued the study during randomization phase due to other reasons.|26 weeks|These are responders at the end of Phase II of the study and were then randomized into Phase III of the study.|||Participants|||Count of Participants
1422365|NCT01077856|Secondary|Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status|The percentage of participants with liquid-based cervical cytology samples positive for HPV 6, 11, 16, and 18 was to be analyzed by Gardasil vaccination status.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
1422366|NCT01077856|Secondary|Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status|The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
1422367|NCT01077856|Secondary|Incidence of Cervical Cancer by Gardasil Vaccination Status|The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
1422368|NCT01077856|Secondary|Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status|The incidence of CIN by Gardasil vaccination status was to be assessed.|Four years to 5 years after Gardasil licensure (2011 to 2012)|The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.||||||
1422369|NCT01077856|Primary|Percentage of Live Born Babies With a Major Congenital Anomaly|The percentage of live born babies with major congenital anomalies (MCA) born to women vaccinated with Gardasil during pregnancy and to women in the general population was assessed. For Denmark and Sweden diagnoses of congenital anomaly within 1 year of birth are included; for Norway diagnoses at birth are included.|Up to 5 years after Gardasil licensure (2007 to 2011)|The analysis population represents the babies born to participating mothers, instead of female participants, because the number of babies represents the denominator for the percentage calculation, not female participants (i.e., mothers)|||Percentage of babies with a MCA|||Number
1422370|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
1422371|NCT01077856|Primary|Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
1422372|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
1422373|NCT01077856|Primary|Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with liquid-based cytology samples analyzed for HPV types|||Percentage of participants||95% Confidence Interval|Number
1422374|NCT01077856|Primary|Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors|The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|Analysis of this endpoint was not planned nor were the data collected. Thus, the number of participants analyzed is zero.||||||
1422375|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422376|NCT01077856|Primary|Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422377|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422378|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422379|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422380|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422381|NCT01077856|Primary|Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422382|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants >26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422383|NCT01077856|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants <=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422384|NCT01077856|Primary|Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.|Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)|The analysis population was participants of all ages with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types|||Cases per 100,000 women|||Number
1422385|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422386|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422387|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422394|NCT01077830|Primary|Crude Rate of Newly Diagnosed Cancer-Follow-up Primary Cohort|Any incidence of cancer reported during follow-up that was assessed by the Expert Review Committee to be a new case of cancer. The crude new cancer rates for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of New Cancers reported was then divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude New Cancer Rate.|up to 21 Months after the end of the SEAS (base) study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.|||per 100 participant-years||95% Confidence Interval|Number
1422388|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women >26 years of age were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of women >26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422389|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422390|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422391|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women >26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women >26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422392|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women <=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women <=26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422393|NCT01077856|Primary|Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark|All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.|Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)|The analysis population was the entire population of qualifying women in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.|||Cases per 100,000 women|cases||Number
1422450|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by the Investigator|Bone marrow (BM) aspiration was performed, and the bone marrow smears were prepared for the assessment of lymphocytes in the BM.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Percentage of lymphocytes in the BM||Standard Deviation|Mean
1422395|NCT01077830|Secondary|Crude Rate of Death Due to Cancer - Follow-up Primary Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain if cancer was cause of death. The crude rates of death due to cancer for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths due to Cancer reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Crude Rate of Death Due to Cancer.|up to 21 Months after the end of the base study|Analysis population was Follow-up Primary Cohort defined as all participants in the follow-up study without a history of cancer before the start of the follow-up period.|||per 100 participant-years||95% Confidence Interval|Number
1422396|NCT01077830|Secondary|Crude Rate of Death (Any Cause) - Follow-up Total Cohort|All deaths reported during follow-up were reviewed by the Expert Review Committee to ascertain cause of death. The crude rates of death for each arm were calculated as follows: Number of participants in the arm was multiplied by the Duration of Follow-up (days) and divided by 365 (days per year) to establish the Total Participant-years for the arm. The Number of Deaths (any cause) reported was divided by the Total Participant-years and the resultant quotient was then multiplied by 100 to determine the Rate of Death.|up to 21 Months after the end of the base study|Primary analysis population was Follow-Up Total Cohort defined as all participants enrolled in the study.|||per 100 participant-years||95% Confidence Interval|Number
1422397|NCT01077817|Primary|Number of Cases of Esophageal Cancer Per 100,000 Woman-Years (Intent-to-Treat Analysis)|To assess the relative risk of esophageal cancer associated with osteoporosis study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene), initiators of osteoporosis drugs and non-initiators (comparators, women sharing match criteria with the initiator) entered an inception cohort for every three-month period, beginning in the first quarter of 1996. Assignment to study drug exposure group remained fixed from the start of follow-up, analogous to an intent-to-treat analysis. The risk of esophageal cancer among initiators of study drug compared to non-initiators of study drug was estimated through calculation of a hazard ratio. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug were used. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug were used.|Up to approximately 7.3 years of follow-up|Inception Cohort came from the Overall Study Population beginning treatment with an osteoporosis study drug (initiators, 78,630 women) and 300,610 matched control women, who did not receive study drug (noninitiators). Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.|||Number of cases per 100,0000 woman-years|||Number
1422398|NCT01077817|Primary|Percentage of Participants With Exposure to Study Drugs (Case-Cohort Analysis)|To determine the use of study drugs (alendronate, etidronate, ibandronate, risedronate, and raloxifene) among female participants with esophageal cancer (cases) and a comparison subcohort, a case-cohort analysis was performed using women meeting criteria from the General Practice Research Database (GPRD, United Kingdom). Exposure to osteoporosis drugs administered 720 days before cancer onset was determined in cases and compared to contemporaneous assessments in a comparison subcohort matched by year of birth and membership in the GPRD on the case's onset date. Cases were confirmed and case onset dates determined by electronic algorithm (based on electronic medical record data) or by medical record review.|Exposure to study drug at least 720 days before disease onset|Case-Cohort analysis population came from the Overall Study Population and comprised 929 women with esophageal cancer (cases) and a Comparison Sample of 338,911 matched control women. Participants may have been exposed to more than one study drug. Also, one comparator may have been used for multiple study drugs.|||Percentage of participants|||Number
1422399|NCT01077804|Secondary|Incidence Rate of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed.|From 6 weeks to 168 months (14 years) post vaccination||||Rate per 1000 person years||95% Confidence Interval|Number
1422400|NCT01077804|Primary|Incidence Rate of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination||||Rate per 1000 person years||95% Confidence Interval|Number
1422401|NCT01077804|Primary|Number of Participants With an Occurrence of Breakthrough Varicella|"Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required."|From 6 weeks to 168 months (14 years) post vaccination||||Participants|||Number
1422402|NCT01077804|Secondary|Number of Participants With an Occurrence of Herpes Zoster Infection|Herpes zoster cases were physician-diagnosed cases.|From 6 weeks to 168 months (14 years) post vaccination||||Participants|||Number
1422403|NCT01077739|Secondary|Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression|Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.|Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months|ITT Population. Number (n) equals (=) number of participants assessed for the given parameter at the specified visit.|||pg/mL||Standard Deviation|Geometric Mean
1422404|NCT01077739|Secondary|Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)|"Percentage of participants with an overall response of CR or PR according to RECIST criteria.~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population; only participants with RECIST evaluations were included in the analysis.|||percentage of participants|||Number
1422405|NCT01077739|Secondary|PFS From the Start of First-Line Therapy|PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population.|||months||95% Confidence Interval|Median
1422406|NCT01077739|Primary|Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression|PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months|ITT population|||months||95% Confidence Interval|Median
1422407|NCT01077713|Secondary|Duration of Response (DoR)|DoR was defined for participants who had achieved an objective response (CR/PR) (whichever status was recorded first) as the time period from first documentation of a response to the date of first occurrence of investigator documented disease progression or death. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters or appearance of one or more new lesions. DoR was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set.|||months||95% Confidence Interval|Median
1422408|NCT01077713|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having CR/PR/SD as per RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set|||percentage of participants||95% Confidence Interval|Number
1422409|NCT01077713|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.|Cycle 3 Day 15, Cycle 6 Day 15 and at Month 6|ITT set|||percentage of participants||95% Confidence Interval|Number
1422410|NCT01077713|Secondary|Percentage of Participants by Best Overall Response|Best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence, assessed according to RECIST criteria v 1.1. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to less than (<) 10 millimeter (mm) in short axis; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesion, and no new lesions; Progressive Disease (PD): at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions; Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death or consent withdrawal (up to 53 months)|ITT set|||percentage of participants||95% Confidence Interval|Number
1422411|NCT01077713|Secondary|Overall Survival (OS)|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization to death or end of the study (up to 53 months)|ITT set|||months||95% Confidence Interval|Median
1422412|NCT01077713|Secondary|Percentage of Participants Who Died||From randomization to death or end of the study (up to 53 months)|ITT set|||percentage of participants|||Number
1422413|NCT01077713|Secondary|Percentage of Participants Alive at 12 Months After Randomization||1 year|ITT set|||percentage of participants||95% Confidence Interval|Number
1422414|NCT01077713|Secondary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Disease progression was assessed according to RECIST criteria v 1.1. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set|||months||95% Confidence Interval|Median
1435854|NCT00966355|Secondary|Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects|at least one of the three criteria|5 days after enrollment||||participants|||Number
1422415|NCT01077713|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST criteria v1.1. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Baseline; Day 15 of Cycles 3 and 6; Month 6 and then every 3 months until disease progression, death, or consent withdrawal (up to 53 months)|ITT set|||percentage of participants|||Number
1422416|NCT01077713|Primary|Percentage of Participants Alive and Without Progressive Disease at Month 6|Disease progression was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (v 1.1). Disease progression was defined at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), progression of existing non-target lesions, or presence of new lesions.|Month 6|Intent-to-treat (ITT) set included all participants in the RND set who received at least one dose of any study medication; participants were classified according to treatment received.|||percentage of participants||95% Confidence Interval|Number
1422417|NCT01077622|Other Pre-specified|Serum Hemolytic Complement Titer at Weeks 36 and 48: CH50|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it's is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation.|Weeks 36 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Kilo units per liter (KU/L)||Standard Deviation|Mean
1422418|NCT01077622|Secondary|Mean Residence Time (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr||95% Confidence Interval|Geometric Mean
1422419|NCT01077622|Secondary|Volume of Distribution at Steady State (Vss) for Ofatumumab|Vss for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body in equilibrium conditions to steady-state plasma concentrations. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||mL||95% Confidence Interval|Geometric Mean
1422420|NCT01077622|Secondary|Volume of Distribution (Vz) During the Terminal Phase for Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||mL||95% Confidence Interval|Geometric Mean
1422421|NCT01077622|Secondary|Clearance (CL) of Ofatumumab From Plasma|CL of ofatumumab from plasma of participants was evaluated. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||mL/hr||95% Confidence Interval|Geometric Mean
1422422|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
1422423|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 672 hr (AUC[0-672]) for Ofatumumab at Week 24|Blood sampling at Week 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 24|PK Parameter Population. Only participants contributing evaluable data at the indicated time points were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
1422424|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 168 hr (AUC[0-168]) for Ofatumumab at Week 7|Blood sampling at Week 7 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Week 7|PK Parameter Population|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
1422425|NCT01077622|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) for Ofatumumab|AUC(0-t) was evaluated from the plasma concentration versus time curve from time zero to the last measurable time point (time t). Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr*mcg/mL||95% Confidence Interval|Geometric Mean
1422426|NCT01077622|Secondary|Half-life (t1/2) of Ofatumumab|t1/2 of ofatumumab is the time required for the plasma concentration of ofatumumab to decrease by half. Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr||95% Confidence Interval|Geometric Mean
1422427|NCT01077622|Secondary|Time to Reach Cmax (Tmax) Following Ofatumumab Administration|Blood sampling on Day 1 and at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||hr||Full Range|Median
1422428|NCT01077622|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Blood sampling at Weeks 7 and 24 for PK evaluation was performed at the following time points: 0.5 hr before infusion; end of infusion; and 10 min, 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), 120 hr (5 days), 168 hr (7 days), and 336 hr (14 days) after infusion of ofatumumab.|Weeks 7 and 24|PK Parameter Population|||mcg/mL||95% Confidence Interval|Geometric Mean
1422429|NCT01077622|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Blood sampling on Day 1 and at Weeks 7 and 24 for pharmacokinetic (PK) evaluation was performed at the following time points: 0.5 hour (hr) before infusion; end of infusion; and 10 minutes (min), 1 hr, 2 hr, 24 hr (1 day), 72 hr (3 days), and 120 hr (5 days) after infusion of ofatumumab. At Weeks 7 and 24, blood sampling was also performed 168 hr (7 days) and 336 hr (14 days) after infusion of ofatumumab.|Day 1; Weeks 7 and 24|PK Parameter Population: all participants who received at least one dose of investigational drug, and in whom PK data were available and allowed parameter estimations. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Micrograms per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1422430|NCT01077622|Secondary|Number of Participants With a Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. The grades for the scale range from 0 (fully active) to 4 (completely disabled), with increasing severity.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
1422431|NCT01077622|Secondary|Number of Participants Who Tested Positive/Negative for Human Anti-human Antibodies (HAHA) at Screening and at Weeks 24 and 48|HAHA are indicators of immunogenicity to ofatumumab.|Screening; Weeks 24 and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
1422432|NCT01077622|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Weeks 8, 24, and 48|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.|Baseline and Weeks 8, 24, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||g/L||Standard Deviation|Mean
1422433|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Extreme Fatigue at the Indicated Weeks|Extreme fatigue is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had extreme fatigue at BL, and still had extreme fatigue at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had extreme fatigue at BL, but did not have extreme fatigue at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
1422434|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Fever at the Indicated Weeks|Fever is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had fever at BL, and still had fever at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had fever at BL, but did not have fever at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
1422435|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Weight Loss at the Indicated Weeks|Weight loss is one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had weight loss at BL, and still had weight loss at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had weight loss at BL, but did not have weight loss at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
1422451|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of lymphocytes.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Giga (10^9) per liter (GI/L)||Standard Deviation|Mean
1435855|NCT00966355|Primary|5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)||5 days after enrollment||||participants|||Number
1422436|NCT01077622|Secondary|Number of Participants With the Indicated Shift From Baseline (BL) in Night Sweats at the Indicated Weeks|Night sweats are one of the clinical characteristics of CLL. B symptoms are systemic symptoms of fever, night sweats, weight loss, and extreme fatigue, which can be associated with CLL. Participants who had night sweats at BL, and still had night sweats at Week 1, for example, are represented in the BL, yes; Week 1, yes category. Participants who had night sweats at BL, but did not have night sweats at Week 1 are represented in the BL, yes; Week 1, no category.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||participants|||Number
1422437|NCT01077622|Secondary|Ratio of Immunoglobulin (Ig) Kappa/Ig Lambda|Peripheral blood Ig kappa and Ig lambda were measured using flow cytometry. Abnormality of a ratio of Ig kappa and Ig lambda indicates clonality of lymphocytes. A normal range of this parameter is between 1.0 and 3.2.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Ratio of Ig kappa/Ig lambda||Standard Deviation|Mean
1422438|NCT01077622|Secondary|Number of Peripheral Blood CD23+ CD5+ Cells|CD23+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422439|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD5+ Cells|CD20+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422440|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD5+ Cells|CD19+ CD5+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422441|NCT01077622|Secondary|Number of Peripheral Blood CD19+ CD23+ Cells|CD19+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422442|NCT01077622|Secondary|Number of Peripheral Blood CD20+ CD23+ Cells|CD20+ CD23+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422443|NCT01077622|Secondary|Number of Peripheral Blood Cluster of Differentiation (CD) CD19+ CD20+ Cells|CD19+ CD20+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus.|Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422444|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total ANC) at the Indicated Weeks as Assessed by a SERC|SERC assessed total neutrophils based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422445|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes as a Percentage in the Bone Marrow at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes in the bone marrow (BM) based on the data with BM smears provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||percentage of lymphocytes in BM||Standard Deviation|Mean
1422446|NCT01077622|Secondary|Mean Laboratory Data for Lymphocytes at the Indicated Weeks as Assessed by a SERC|SERC assessed lymphocytes based on the data provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422447|NCT01077622|Secondary|Percentage of Bone Marrow Infiltration at the Indicated Weeks as Assessed by a SERC|SERC assessed bone marrow infiltration with the bone marrow smears of participants provided by trial sites.|Weeks 8, 16, 24, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Percentage of bone marrow infiltration||Standard Deviation|Mean
1422448|NCT01077622|Secondary|Mean Laboratory Data for Platelet Count at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of platelets.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422449|NCT01077622|Secondary|Mean Laboratory Data for Total Neutrophils (Total Absolute Neutrophil Count [ANC]) at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of total neutrophils.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||GI/L||Standard Deviation|Mean
1422452|NCT01077622|Secondary|Mean Laboratory Data for Hemoglobin at the Indicated Weeks as Assessed by the Investigator|Blood samples of the participants were collected for the assessment of hemoglobin.|Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28, 36, and 48|All Subjects Population. Only participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1422453|NCT01077622|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy as Assessed by a SERC|Time to next CLL therapy is defined as the time from the first infusion of investigational drug to the first administration of the next CLL treatment. CLL therapy includes anti-cancer chemotherapy, anti-cancer radiotherapy, radio-immunotherapy, and antibody therapy.|Up to Week 48|All Subjects Population: only those participants who received CLL therapy were evaluated.|||Weeks||95% Confidence Interval|Median
1422454|NCT01077622|Secondary|Time to Response as Assessed by a SERC|Time to response is defined as the time from the first infusion of investigational drug to the first response (PR or better).|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.|||Weeks||95% Confidence Interval|Median
1422455|NCT01077622|Secondary|Overall Survival|Overall survival is defined as the time from the first infusion of investigational drug to death due to any cause.|Up to Week 48|All Subjects Population|||Weeks||95% Confidence Interval|Median
1422456|NCT01077622|Secondary|Duration of Response as Assessed by a SERC|Duration of response is defined as the time from the first documented evidence of PR or better until the first documented sign of PD or death due to any reason in participants with PR or better.|Up to Week 48|All Subjects Population: only those participants classified as responders for the assessment of objective response were evaluated.|||Weeks||95% Confidence Interval|Median
1422457|NCT01077622|Secondary|Progression-free Survival (PFS) as Assessed by a SERC|PFS is defined as the time from the start of treatment to the first documented sign of progressive disease (PD) or death due to any cause (whichever occurs earlier).|Up to Week 48|All Subjects Population: only those participants who progressed or died during the study were evaluated.|||Weeks||95% Confidence Interval|Median
1422458|NCT01077622|Primary|Percentage of Participants (Par.) With Objective Response (OR), Defined as Complete Remission (CR), CR Incomplete (CRi), Partial Remission (PR), and Nodular PR (nPR) as Assessed by a Safety and Evaluation Review Committee (SERC) and the Investigator|Par. were evaluated in accordance with the National Cancer Institute-sponsored Working Group. CR: no lymphadenopathy (Ly)/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils >=1.5*10^9/liter (L), platelets >100*10^9/L, hemoglobin >11.0 grams/deciliter, lymphocytes (LC) <4.0*10^9/L, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to chronic lymphocytic leukemia but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen, etc. nPR: nodules in BM.|Up to Week 48|All Subjects Population|||Percentage of participants|||Number
1422459|NCT01077622|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as the following toxicological findings, according to the Common Terminology Criteria for Adverse Events (AE) v3.0: any treatment-related Grade (G) >=3 non-hematotoxic AE, occurrence of G3 infusion reaction (treatment-related AE) at the day of infusion in a participant who received pre-medication or appropriate management during infusion (glucocorticoid) (the severity of the AE must have remained as >= G3 until the next day); and any of following: >= G4 hematotoxic treatment-related AEs (neutropenia lasting 7 days or more, febrile neutropenia).|Up to Week 8|All Subjects Population: all participants who received at least one dose of investigational drug. The first 3 participants enrolled in the study were evaluated for DLT according to study design.|||participants|||Number
1422460|NCT01077596|Secondary|Number of Participants Diagnosed With Prostate Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, prostate cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Prostate cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with prostate cancer who were new antidepressant users.|||participants|||Number
1422461|NCT01077596|Secondary|Number of Participants Diagnosed With Breast Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, breast cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Breast cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with breast cancer who were new antidepressant users.|||participants|||Number
1422462|NCT01077596|Secondary|Number of Participants Diagnosed With Uterine Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, uterine cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Uterine cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with uterine cancer who were new antidepressant users.|||participants|||Number
1422463|NCT01077596|Secondary|Number of Participants Diagnosed With Bladder Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, bladder cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Bladder cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with bladder cancer who were new antidepressant users.|||participants|||Number
1422464|NCT01077596|Secondary|Number of Participants Diagnosed With Lung Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, lung cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Lung cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with lung cancer who were new antidepressant users.|||participants|||Number
1422465|NCT01077596|Secondary|Number of Participants Diagnosed With Colorectal Cancer Who Were Regularly Exposed to the Indicated Antidepressant|In this outcome, colorectal cancer is under investigation: Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Colorectal cancer cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with colorectal cancer who were new antidepressant users.|||participants|||Number
1422466|NCT01077596|Primary|Number of Participants Diagnosed With Any of the Cancers Under Investigation Who Were Regularly Exposed to the Indicated Antidepressant|The following are the cancers under investigation: colorectal, lung, bladder, uterus, breast, and prostate. Cancer case were nested within a cohort of new antidepressant users. New antidepressant users were defined as no previous antidepressant prescription in the previous 6 months. Cases were identified and matched with controls from the same new-user cohort. Cal year, calendar year; dx, diagnosis; IBD, Inflammatory Bowel Disease; OC, oral contraceptive; HRT/ERT, hormone replacement therapy/estrogen replacement therapy; NSAID, non-steroidal anti-inflammatory drug.|January 1, 1996 – December 31, 2006|Participants diagnosed with colorectal, lung, bladder, uterus, breast, or prostate cancer who were new antidepressant users|||participants|||Number
1422467|NCT01077544|Secondary|Efficacy Endpoints for Ph+ ALL Patients|Best Response in Ph+ ALL patients was defined as either Complete Remission (CR) with platelet recovery, Complete Remission (CR) with incomplete platelet recovery, Partial Remission (PR) or Stable disease. Stable disease was defined is defined as failure to qualify for either CR, PR, or progressive disease.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.|||Participants|||Number
1422468|NCT01077544|Secondary|Number of Ph+ CML Participants With Major Molecular Response (MMR)|The bcr-abl gene fusion encodes for a BCR-ABL fusion protein. Depending on the precise location of the fusion, the molecular weight of this protein can range from 185 to 210 kDa. Consequently BCR-ABL is referred to as p185 or p210 transcript. For the patients expressing the major BCR-ABL transcript p210, molecular response was defined and reported as the percent ratio of BCR-ABL transcripts/control gene transcripts converted to a reference standard according to the International Scale (IS). A major molecular response (MMR) is defined as a BCR-ABL/control gene ratio ≤ 0.1% (equal to a 3 log reduction in BCR-ABL transcripts) on the IS. In this study, the control gene was abl.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.|||Participants|||Number
1422469|NCT01077544|Secondary|Number of Ph+ CML Participants With Cytogenic Response|Cytogenetic response was initially assessed as the percentage of Ph+ metaphases in the bone marrow (BM) and performed within 21 days prior to study entry. A major cytogenetic response (0% to 35% Ph+ metaphases test positive for the Philadelphia chromosome) combines both complete cytogenetic (CCyR) and partial cytogenetic response (PCyR). CCyR implies 0% Ph+ metaphases in the BM, PCyR is > 0% to 35%, minor cytogenetic response (mCyR) is > 35% to 65%, minimal response is > 65% to 95% and no response is > 95% Ph+ metaphases in the BM.|minimum of 12 cycles (28 days per cycle)|FAS consist of all patients (pts) who passed screening & are enrolled into study. Patients may or may not have taken study drug. One (1) Ph+ CML patient in Group 2 was Ph+ at baseline & discontinued study prior to subsequent cytogenetic assessment. This pt doesn’t appear in any cytogenic response category.|||Participants|||Number
1422470|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: Cmin|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose.|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1422471|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||L/h/m^2)||Geometric Coefficient of Variation|Geometric Mean
1422472|NCT01077544|Primary|Summary of Nilotinib Steady-state PK Parameters: AUCss|The steady-state PK profiles of nilotinib in pediatric patients were estimated using trough sampling following multiple 230 mg/m2 bid doses|Cycle 1 Day 8 - Cycle 1 Day 28|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1422473|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1422496|NCT01077310|Secondary|Alcohol Treatment Outcome: Time to Alcohol Relapse|Self reported time to first heavy drinking day after release from incarceration, up to 6 months|Post release||||days||Standard Deviation|Mean
1454695|NCT00815659|Secondary|Basal LDL-6 Level|LDL-6 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-6 levels of participants|||mg/mL||Standard Deviation|Mean
1422474|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h)|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1422475|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Tmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||h||Full Range|Median
1422476|NCT01077544|Secondary|Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)|A confirmed complete hematological response (CHR) is defined when all of the following criteria are achieved at two consecutive assessments, at least 4 weeks apart: white blood cell (WBC) count < 10 × 109/L; platelet < 450 × 109/L; basophils < 5%; no blasts and promyelocytes in peripheral blood (PB); myelocytes + metamyelocytes < 5% in PB; and no extramedullary involvement. The information used for hematological assessment was to be obtained from the laboratory and extramedullary data, all merged by patient and date.|minimum of 12 cycles (28 days per cycle)|Full analysis set (FAS): consists of all patients who passed the screening and are enrolled into the study. Patients may or may not have taken study drug.|||Participants|||Number
1422477|NCT01077544|Primary|Summary of Nilotinib Non-compartmental PK Parameters: Cmax|The full PK profiles of nilotinib in pediatric patients were assessed using serial sampling following a single 230 mg/m2 dose on Cycle 1 Day 1.|Cycle 1 Day 1|Pharmacokinetic Analysis Set (PAS) consists of all patients who received the nilotinib dose on Day 1, had an evaluable Day 1 PK profile or provided at least one evaluable steady state trough concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1422478|NCT01077401|Secondary|Mean Change in Retinal Thickness at Month 6||baseline to6 Months|Data was not collected for 4 participants in the Ranibizumab 0.5mg group for this outcome measure.|||µm||Standard Deviation|Mean
1422479|NCT01077401|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline to Month 6|Mean change in best corrected visual acuity (BCVA) (ETDRS) at 4 meters in the study eye over time through month 6.|baseline 6 Months||||letters||Standard Deviation|Mean
1422480|NCT01077401|Primary|Deaths Due to Myocardial Infarction||6 Months||||participants|||Number
1422481|NCT01077375|Secondary|Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score|The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).|Change from Baseline (Week 3) to Visit 5 (Week 13)|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.|||Units on a scale||Standard Deviation|Mean
1422482|NCT01077375|Primary|Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)|The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.|Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach.|ITT Population: patients in the Double-blind Safety Population with ≥ 1 PGIC post-baseline assessment. Double-blind Safety Population includes 6 patients who were not included in ITT population. Presented results generated via LOCF approach. No statistical comparisons between groups are presented; study was exploratory, not hypothesis-testing.|||participants|||Number
1422483|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escaped, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
1422484|NCT01077362|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher scores and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, the analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate the impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens and differed only with regards to prior exposure to anti-TNFα therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression would be provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.|||Score on a scale||Standard Deviation|Mean
1422497|NCT01077310|Primary|Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL|Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.|Baseline to month 6 post release|Logistic regression backward stepwise models were used to find predictors of HIV viral suppression.|||percent of participants|||Number
1422485|NCT01077362|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
1422486|NCT01077362|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.|||Percentage of participants|||Number
1422487|NCT01077362|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Score on a scale||Standard Deviation|Mean
1422488|NCT01077362|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
1422489|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Past Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is past use period, described as time following recent use excluding subsequent current or recent use."|43 months|Time on Drug Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
1422490|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (Among Recent Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is the recent use period, described as time following current use plus an additional 31 days excluding subsequent current use."|43 months|Time on Drug Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
1422491|NCT01077323|Secondary|Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis Among Initiators of Exenatide, Diabetics Initiating Other Antidiabetic Drugs, and the Non-diabetes Cohort - Intent to Treat Analysis|Crude intent-to-treat incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort.|43 months|Intent to Treat Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
1422492|NCT01077323|Primary|"Incidence Rates Per 100,000 Person-Years of Likely Acute Pancreatitis (During Current Use Period) - Time on Drug Analysis"|"Crude time-on-drug incidence rate per 100,000 person-years of likely acute pancreatitis in initiators of exenatide, initiators of other antidiabetic drugs and the non-diabetes cohort. Analysis period is current use period, described as time during current day's supply plus 31 days."|43 months|Time on Drug Analysis|||Cases per 100,000 person-years||95% Confidence Interval|Number
1422493|NCT01077310|Other Pre-specified|Mean Change in CD4 Cell Count (Cells/mL)|Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.|Baseline and every 3 months for 1 year|These data were not able to be collected for analysis.||||||
1422494|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days|change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.|change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release||||percent of heavy drinking days||Standard Deviation|Mean
1422495|NCT01077310|Secondary|Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day|The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day|12 weeks prior to release from prison (baseline) to 6 months post release||||standard units of alcohol||Standard Deviation|Mean
1422498|NCT01077284|Secondary|Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance|Creatinine clearance is a measure of how well the kidneys are filtering creatinine, a waste product produced by the muscles. Measured creatinine clearance was calculated according to the following: Urine 24 hour Creatinine/Serum Creatinine x (total Urine volume/elapsed time) x (1.73/body surface area).|Baseline and Month 6|Full analysis set. Missing Month 6 Visit 24-hour mCLcr values are imputed by Month 3 values if the Month 3 value was available otherwise the patient was excluded from the analysis.|||mL/min/1.73m²||Standard Deviation|Mean
1422499|NCT01077284|Secondary|Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones|Multidetector Computed Tomography (MDCT) was used to visualize and count calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader.|Baseline and Month 6|Full analysis set for whom both Baseline and Month 6 MDCT data were available. Measurements more than 1 day after a patient’s last dose of study drug were not included.|||stones||Standard Deviation|Mean
1422500|NCT01077284|Secondary|Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone|Multidetector Computed Tomography (MDCT) was used to visualize and measure calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader. The change from Baseline to month 6 is expressed as a percentage of the Baseline largest in-plane diameter.|Baseline and Month 6|Full analysis set, for whom Baseline and Month 6 MDCT data were available. Measurements more than 1-day after a patient's last dose of study drug were not included.|||percent change||Standard Deviation|Mean
1422501|NCT01077284|Primary|Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion|The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.|Baseline and Month 6|The full analysis set (patients who took at least 1 dose of double-blind study drug and had a baseline 24-hour uUA >700 mg and at least 1 kidney CaOx stone ≥3 mm in its longest inplane diameter). Missing Month 6 values were imputed with baseline values if patient discontinued due to an AE; or otherwise with the last available post-baseline value.|||percent change||Standard Deviation|Mean
1422502|NCT01077271|Secondary|Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale|The therapeutic effect of palivizumab was assessed by the treating physician using a visual analog scale from 0 to 10, where 0 indicated that palivizumab did not match expectations at all and 10 indicated that palivizumab met all expectations. The physician rated palivizumab treatment for each participant at the last study visit (LSV) or, in the case of participants withdrawing from the study, at the early termination (ET) visit.|One RSV season (5 months), end of study|The analysis included participants who were administered palivizumab and had data available for the study visits listed. A total of 100 participants were rated at the last study visit; 2 did not have ratings. A total of 18 participants who discontinued from the study were rated at the early termination visit.|||units on a scale||Standard Deviation|Mean
1422503|NCT01077271|Secondary|Parents Knowledge of Burden of RSV Disease Via Interview by Physician|"An informational brochure was given to parents of participants. Parents were interviewed by the treating physician at the first study visit (V1) and last study visit (LSV) (or early termination visit [ET]) for those participants discontinuing from the study). Parental knowledge of the burden of respiratory syncytial virus (RSV) disease was assessed using a questionnaire. Parents were considered to have “good RSV awareness if all questions were answered and at least 3 of the 4 questions regarding the burden of RSV disease were answered correctly."|One RSV season (5 months)|The analysis included parents of participants who were administered and had data available for the study visits listed.|||Parents of participants|||Number
1422504|NCT01077271|Secondary|Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)|The clinician who administered the palivizumab injection was asked to rate pain during injection using a visual analog scale (VAS) and the Modified Behavior Pain Scale (MBPS) as published by Carbajal et al., 2008. The VAS ranged from 0 (no pain) to 100 (maximum pain). The Modified Behavioral Pain Scale ranged from 0 (no pain) to 10 (maximum pain) through the evaluation of 3 items: Facial expressions, cry, and movements. If more than one injection was given at a visit, then the first injection was rated.|One RSV season (5 months)|The analysis included participants who were administered palivizumab and had data available for the study visits listed.|||units on a scale||Standard Deviation|Mean
1422505|NCT01077271|Primary|Dosage Per Administration|The median dose and range of palivizumab (milligrams) that was administered at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.|||milligrams||Full Range|Median
1422506|NCT01077271|Primary|Interval Between Administrations|The average number of days that elapsed between palivizumab injections administered at the previous study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.|||Days||Standard Deviation|Mean
1422507|NCT01077271|Primary|Body Site of Injections Per Administration|The body site of injection administration for participants at each study visit.|One RSV season (5 months)|The analysis population includes participants who were administered palivizumab and had data available for the study visits listed.|||participants|||Number
1422508|NCT01077271|Primary|Number of Injections Per Patient Per Season|The average number of injections administered per participant within a respiratory syncytial virus season.|One RSV season (5 months)|Participants who were administered palivizumab were included in the analysis.|||Injections administered||Standard Deviation|Mean
1422509|NCT01077258|Secondary|Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication||Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
1422510|NCT01077258|Secondary|Percentage of Participants With In-patient Hospitalization|The percentage of participants with in-patient hospitalization in the prior 6 months. Baseline data includes in-patient hospitalizations that occurred within the prior 12 months.|Month 6, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
1423719|NCT01067105|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population|||percentage of devices|||Number
1422511|NCT01077258|Secondary|Number of Days Missed From Work Due to Rheumatoid Arthritis|Participants reported the number of days they had missed from work in the prior 6 months. The Baseline measurement includes data for the prior 12 months.|Baseline and Months 6, 12, 18, and 24|Full analysis set participants who were employed and with available data at each time point (indicated by n)|||days||Standard Deviation|Mean
1422512|NCT01077258|Secondary|Percentage of Participants With Impairment in Daily Activities|Participants were asked to report how many days of impairment in daily activities they had experienced in the last 4 weeks.|Baseline and Months 3, 6, 9, 18, and 24|Full analysis set with available data at each time point|||percentage of participants|||Number
1422513|NCT01077258|Secondary|Participants Assessment of Pain Over Time|Participants indicated their level of pain over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||cm||Standard Deviation|Mean
1422514|NCT01077258|Secondary|Participants Assessment of Fatigue Over Time|Participants indicated their level of fatigue over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Month 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||cm||Standard Deviation|Mean
1422515|NCT01077258|Secondary|Patients Global Assessment of Disease Activity Over Time|Participants indicated their global assessment of disease activity over the last 7 days on a visual analog scale (VAS) from 0 (best) to 10 (worst) cm; lower scores indicate better patient status.|Baseline and Months 3, 6, 9, 12, 18 and 24|Full analysis set with available data at each time point (indicated by n)|||cm||Standard Deviation|Mean
1422516|NCT01077258|Secondary|Hannover Functional Questionnaire (FFbH) Over Time|"A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score. The FFbH was calculated from this patient score by the following formula:~FFbH = (patient score x 100) ÷ 2 (number of valid responses). The resulting FFbH score reflects the degree of remaining functional capacity where 0 indicates maximal impairment and 100 indicates maximal functional capacity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||units on a scale||Standard Deviation|Mean
1422517|NCT01077258|Secondary|Swollen Joint Count (SJC) Over Time|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||swollen joints||Standard Deviation|Mean
1422518|NCT01077258|Secondary|Tender Joint Count (TJC) Over Time|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||tender joints||Standard Deviation|Mean
1422519|NCT01077258|Secondary|C-Reactive Protein (CRP) Levels Over Time|C-Reactive Protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||mg/L||Standard Deviation|Mean
1422520|NCT01077258|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||mm/hour||Standard Deviation|Mean
1422521|NCT01077258|Secondary|Percentage of Participants With Low, Moderate and High Disease Activity|"The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.~Low disease activity is defined as a DAS28 score ≤ 3.2; Moderate disease activity as a DAS28 >3.2 to ≤5.1; High disease activity as a DAS28 >5.1."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point|||percentage of participants|||Number
1422522|NCT01077258|Secondary|Percentage of Participants With a Significant Therapeutic Response|"Significant therapeutic response was determined by DAS28 critical difference (Dcrit). A Dcrit response is a statistically determined value that exceeds the threshold of random fluctuation and signifies a positive individual response during treatment. A DAS28-Dcrit individual therapeutic response is defined as a decrease (improvement) in DAS28 from Baseline of ≥ 1.8.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity."|Baseline and Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
1422523|NCT01077258|Primary|Percentage of Participants in DAS28 Remission|Clinical remission is defined as a disease activity score (DAS) 28 score of < 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient’s assessment of global disease activity (assessed on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.|Months 3, 6, 9, 12, 18, and 24|Full analysis set with available data at each time point (indicated by n)|||percentage of participants|||Number
1422534|NCT01077050|Secondary|Sensitivity and Specificity|"Secondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis.~Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia)~Negative Reference Diagnosis: All other skin lesions."|Post data lock||2013-08-31|08/2013||||
1422524|NCT01077258|Primary|Change From Baseline in Disease Activity Score (DAS) 28|The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline and Months 3, 6, 9, 12, 18, and 24|"Full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS. n indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
1422525|NCT01077193|Primary|Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward|"Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.~One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL"|3 years||||percentage of baseline excess weight||Standard Deviation|Mean
1422526|NCT01077128|Secondary|Assessment of Long Term Use and Safety of Adalimumab as Prescribed by the Dermatologist in a Normal Clinical Setting and in Accordance With the Terms of the European Marketing Authorization|An adverse event (AE) was defined as any untoward medical occurrence in a participant, which did not necessarily have a causal relationship with their treatment. Any worsening of a pre-existing condition or illness was considered an adverse event.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)||||Participants|||Number
1422527|NCT01077128|Secondary|Mean Change From Baseline of European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Visual Analogue Scale (VAS) Scores|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.~It has two components:~the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and~the EQ-5D VAS. EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either “problem” or “no problem” with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||units on a scale||Standard Deviation|Mean
1422528|NCT01077128|Secondary|"Percentage of Patients Reporting No Problem on the European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D)"|"EQ-5D (European Quality of Life - 5 Dimensions Questionnaire) is a standardized instrument for use as a measure of health outcome.~It has two components:~the EQ-5D descriptive system (i.e., the EQ-5D Index Score, comprised of five items), and~the EQ-5D VAS. The EQ-5D Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients reported either “problem” or “no problem” with each of the five dimensions of health. The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively."|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||Percentage of patients with no problem|||Number
1422529|NCT01077128|Secondary|Mean Change in the Dermatology Life Quality Index (DLQI) Score by Physician’s Global Assessment of Disease Severity (PGA) Response Groups and by Geographical Region|The average change in the Dermatology Life Quality Index (DLQI) score during the 12-month study was analyzed by the Physician’s Global Assessment of disease severity (PGA) response and also by geographical location of study participants. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life. . In this table, a higher number means a greater improvement in the participants’ quality of life.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||units on a scale||Standard Deviation|Mean
1422530|NCT01077128|Secondary|Percentage of Patients Who Experienced an Improvement in Disease Severity as Determined by the Physician’s Global Assessment of Disease Severity (PGA) Scores|The Physician's Global Assessment of disease severity (PGA) was used to measure participants’ disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores was recorded.|12-month period (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||Percentage of patients improving|||Number
1422531|NCT01077128|Primary|Mean Change of Dermatology Life Quality Index (DLQI) Scores|DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.|12-month period, (Month 0, Month 1, Month 4, Month 8, Month 12)|Participants with available data at each time point|||units on a scale||Standard Deviation|Mean
1422532|NCT01077076|Primary|Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment|Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments|4 hours after dose on Day 4|"Pharmacodynamic-Evaluable Population: All participants who presented valid data from all three study periods.~One participant was dropped from the Pharmacodynamic-Evaluable Population in the Prilosec OTC Tablets group because of invalid pH tracings at Day 4. Therefore, the number of participants included at Day 4 in this group was 26."|||Percentage of Time||Standard Deviation|Mean
1422533|NCT01077063|Primary|Safety of Pleurx Catheter or Paracentesis|"Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis~Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure."|3 years||||events|||Number
1423600|NCT01068730|Secondary|Participants With Abnormal Vital Sign Findings Reported as an AE|per investigator|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
1422535|NCT01077050|Primary|SciBase Sensitivity and Specificity|"This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device:~Sensitivity ≥ 0.90 to detect Melanoma~Sensitivity – (1-Specificity) > 0.00~Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma."|Post data lock|Biopsied Skin Lesions|||Percentage of total lesions|Participants|95% Confidence Interval|Mean
1422536|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|6 month visit||||percentage of participants|||Number
1422537|NCT01077024|Secondary|Stimulant-free Results at 6-month Visit|At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|6 - months follow-up visit|This outcome was only compared for participants who attended the 6-month follow-up visit (n=210 and n=218, respectively).|||percentage of participants|||Number
1422538|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|3- month follow-up visits||||percentage of participants|||Number
1422539|NCT01077024|Secondary|Stimulant-free Results at 3-month Visit|At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.|3-month follow-up visit|This outcome was only compared for participants who attended the 3-month follow-up visit (n=226 and n=240, respectively).|||percentage of participants|||Number
1422540|NCT01077024|Secondary|Four Week Continuous Smoking Abstinence|A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 – 42.|Post-quit days 15-42||||percentage of participants|||Number
1422541|NCT01077024|Secondary|Point-prevalence Abstinence (Smoking Outcome)|point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm|Week 10 assessment||||percentage of participants|||Number
1422542|NCT01077024|Primary|Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens|Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free.|Week 16||||percentage of weeks|||Number
1422543|NCT01076985|Primary|Number of Patients With Adverse Drug Reactions (ADRs)|"The number of patients (mothers and infants) with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear). ADRs are reported by preferred term and inclusive of all those reported at any visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During pregnancy and for one year after birth|All available observed data for all participants and their resulting infants/live births are included.|||participants|||Number
1422544|NCT01076972|Primary|Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents|Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).|Baseline (Month 0) and following last treatment dose during the course of the survey period|Available data for all patients were included.|||participants|||Number
1422545|NCT01076972|Primary|Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit|Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.|||copies/mL||Standard Deviation|Mean
1422546|NCT01076972|Primary|Cluster of Differentiation 4 Lymphocyte Count (CD4)|The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.|Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period|Available data at each visit for each subgroup of patients who had not received and received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline or treatment data were missing for a given visit were excluded from the analysis for that visit.|||cells per cubic millimeter||Standard Deviation|Mean
1422639|NCT01075984|Primary|Single Dose Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
1422547|NCT01076972|Primary|Total Number of Patients With Adverse Drug Reactions|"Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than not related by the investigator (i.e., probable, possible, or unclear), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term."|During the course of the survey period up to Year 8|Available data for all patients were included.|||participants|||Number
1422548|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||Percentage of Patients|||Number
1422549|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 12|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||percentage of patients|||Number
1422550|NCT01076959|Primary|Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4|Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).|Week 4|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||Percentage of patients|||Number
1422551|NCT01076959|Secondary|Physicians' Overall Effectiveness Response Rating|"Physicians' rated the level of overall patient improvement as markedly improved, improved, not changed, or not assessable by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions."|Week 24|Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.|||Percentage of Patients|||Number
1422552|NCT01076959|Primary|Total Number of Patients With Adverse Events|Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.|Baseline to Week 24|The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.|||Percentage of Patients|||Number
1422553|NCT01076686|Primary|Number of Subjects With Breast Implant Rupture|Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty|12 to 24 months post surgery||||participants|||Number
1422554|NCT01076647|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
1422555|NCT01076647|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1422556|NCT01076504|Secondary|Toxicity/Safety|Grade 3/4 toxicities|36 months|All enrolled and treated patients|||participants|||Number
1422557|NCT01076504|Secondary|Overall Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|84 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
1422558|NCT01076504|Secondary|Time to Progression|Time to progression will be defined as the time from first treatment until objective tumor progression (PD). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|36 months|Includes all enrolled and treated patients|||weeks||Full Range|Median
1422559|NCT01076504|Secondary|Objective Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|36 months|Includes all patients who were treated and evaluated for response (74 patients - 6 were deemed not evaluable)|||percentage of evaluable participants|||Number
1422560|NCT01076504|Primary|1-year Survival|Percentage of patients still alive one year after their first treatment|12 months|All enrolled and treated patients|||percentage of participants||95% Confidence Interval|Number
1423601|NCT01068730|Secondary|Participants With Abnormal Physical Findings|Physical findings that were considered abnormal by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
1422561|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part IV (Complication of Therapy) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part IV includes four categories (11 items) related to dyskinesias, clinical fluctuations of symptoms, and other complications. A summary score ranging from 0 to 23 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months||||units on a scale||Standard Deviation|Mean
1422562|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part II (Activity of Daily Living) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part II has 13 items focusing on activities of daily living including walking, writing, dressing and speech. A summary score ranging from 0 to 52 is generated by adding the 13 items. The higher score indicates worse condition.|Baseline and 24 months||||units on a scale||Standard Deviation|Mean
1422563|NCT01076452|Primary|The Change From Baseline in the UPDRS-III Score at 24 Months With Deep-brain Stimulation and Without Medication.|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson’s Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The higher score indicates the worse motor function.|Baseline and 24 months||||units on a scale||95% Confidence Interval|Mean
1422564|NCT01076452|Secondary|The Change From Baseline in the UPDRS Scores Part I (Mentation) at 24 Months.|The UPDRS has four parts (Parts I-IV) in which a total of 42 disease characteristics are assessed. Most characteristics are assessed according to their severity on a 0-4 scale (0 = normal, 4 = most substantial impairment), and some are assessed only for absence (score = 0) or presence (score = 1). Part I has four items assessing intellectual impairment, thought disorder, depression and motivation. A summary score ranging from 0 to16 is generated by adding the four items. The higher score indicates worse condition.|Baseline and 24 months||||units on a scale||Standard Deviation|Mean
1422565|NCT01076400|Primary|Part 2: Length of Time for Progression-free Survival (PFS)|PFS is the length of time during and after treatment that a participant lives, but whose tumor progression does not worsen. PFS is defined as the time from randomization to progressive disease or death, whichever occurs earlier. Tumor volume changes of +20% for progressive disease was used to be consistent with RECIST 1.1.|Up to approximately 1 year|Due to the early termination of the study Part 2 was not performed.||||||
1422566|NCT01076400|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)|A DLT is a protocol-defined, (hematologic and non-hematologic), AE that must be definitely, probably, or possibly related to the study therapy. A DLT is any of the following: Grade 4-5 hematological toxicity; Grade 3 or Grade 4 neutropenia with fever >38.°C and/or infection requiring antibiotic or anti-fungal treatment. Non-hematologic dose-limiting toxicities are any Grade 3, 4, or 5 non-hematologic toxicity, with specific exceptions. If occurring within the first cycle of combination therapy: unresolved drug-related toxicity, preventing (re) treatment for 3 weeks or more from the date of the next scheduled treatment or any drug-related toxicity preventing the participant from taking at least 75% of the doses of MK-1775 with each administration of chemotherapy.|Up to approximately 1 year|Participants who completed the first cycle of combination therapy or discontinued from the study due to a DLT attributable to study therapy. One participant who violated the protocol was not assessed for DLTs.|||Number of participants|||Number
1422567|NCT01076400|Primary|Part 1: Percentage of Participants Whose Best Confirmed Response is Partial Response (PR) or Complete Response (CR)|On the basis of Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PR is at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. CR is the disappearance of all extranodal target lesions, where all pathological lymph nodes must have decreased to <10 mm in the short axis.|Up to approximately 1 year|The study was prematurely terminated, and data were not collected, so no analyses were performed.||||||
1422568|NCT01076361|Primary|Survival Probability of the Model 4968 Lead Based on Lead-related Complications|The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.|The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.|22 Model 4968s (in 21 participants) was not available for analysis|||percentage of Model 4968 Leads|Participants|95% Confidence Interval|Number
1422569|NCT01076348|Primary|Model 4965 Complication Free Rate|A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.|1 year|Patients ≥ 19 yrs at implant of MDT 4965 Epicardial Lead.|||Model 4965 complication free rate|4965 leads|95% Confidence Interval|Number
1422570|NCT01076335|Primary|Number of Participants Progression Free at 1 Year|Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml − 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.|1 Year|One participant of 40 enrolled declined presurgical therapy after enrollment and was excluded from analysis.|||participants|||Number
1422571|NCT01076296|Primary|Percentage of Correct Diagnosis|A comparison of the percentages of correct diagnosis by VSCAN and clinical exam using a McNemar test for matched pairs with ECHO used as the gold standard.|2 years||||percentage of correct diagnosis||95% Confidence Interval|Number
1422572|NCT01076283|Primary|Alcohol Drinking|"Whether baclofen, as compared to active placebo, results in lower quantity of alcohol consumed during the Alcohol Self-Administration (ASA).~Consistent with O'Malley et al. 2002, the ASA paradigm allows to use a fixed-dose (the priming drink), followed by a 2-hour “free-choice” phase when subjects may choose to drink or not up to 8 mini-drinks. Participants receive a monetary compensation of $3 dollars per each mini-drink not consumed; therefore the amount of minidrinks consumed during the 2-hour sessions ranges 0-8, and the monetary compensation ranges $0-24. The quantity of alcohol consumed during the free-choice session is expressed as standard drinking unit, where a standard drink unit contains about 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons)."|approximately 8 days after drug administration||||standard drinking units||Standard Deviation|Mean
1422573|NCT01076283|Primary|Alcohol Urge|"Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Urge Questionnaire (AUQ)] during the Cue Reactivity.~The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent’s feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from strongly disagree to strongly agree. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by summing the item scores and ranges from 8 (lowest craving value) to 56 (highest craving value). Higher scores reflect greater craving (i.e. worse outcome)."|approximately 8 days after drug administration||||units on a scale||Standard Deviation|Mean
1422574|NCT01076270|Secondary|CD34-positive Cells Collected|Number of CD34-positive cells collected per kg recipient body weight|At the end of apheresis for cell collection|Trial terminated; only one patient enrolled|||CD34-positive cells collected/kg|||Number
1422575|NCT01076270|Primary|Successful Collection of Stem Cells|Percentage of donors from whom at least 2 x 10^6 CD34+ cells/kg body weight were collected based on actual recipient body weight|At the end of apheresis for cell collection|Study terminated early. Results are for the one donor enrolled.|||Participants|||Count of Participants
1422576|NCT01076244|Secondary|Quality of Life as Measured by Physical Function Scale of the Zurich Claudication Questionnaire (ZCQ).|For this ZCQ domain, a mean score of 1 is the best possible outcome representing 'no limitation' in physical function, whereas a mean score of 4 indicates worst physical function. Zurich Claudication physical function scale from this validated lumbar spine-specific measurement questionnaire are reported below as change from baseline to month 6. A positive value represents the baseline value minus the 6 month value. Treatment is considered clinically relevant when at least a 0.5 improvement is achieved.|Baseline and month 6|All available patients at the month 6 reporting period were analyzed.|||units on a scale||95% Confidence Interval|Mean
1422577|NCT01076244|Primary|Pain as Measured by Visual Analog Scale (VAS).|A validated ten point scale was used where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to six months is presented below, where a positive value represents the baseline value minus the 6 month value.|Baseline and six months|all available patients reporting at Month 6|||units on a scale||95% Confidence Interval|Mean
1422578|NCT01076244|Secondary|Quality of Life as Measured by the Symptom Severity Scale of the Zurich Claudication Questionnaire (ZCQ).|As a validated patient outcome tool specific to lumbar spinal stenosis, Zurich Claudication Questionnaire (ZCQ) captures symptom severity as a quality of life indicator. A mean score of 1 is the best possible outcome representing 'no pain' in symptom severity, whereas higher mean scores up to a maximum of 5 indicate worse patient symptoms. The symptom severity outcomes are presented below as change from baseline to month 6 where a positive value represents the baseline value minus the 6 month value. Treatment is considered 'successful' or 'clinically relevant' if the patient population has at least a 0.5 improvement in symptom severity.|Baseline and month 6|All patients having a month six report report were analyzed.|||units on a scale||95% Confidence Interval|Mean
1422579|NCT01076244|Secondary|Improvement in Functional Mobility|Measured subjectively by the Oswestry Disability Index. Extent of disturbance in activities of daily living is subjectively reported using this validated instrument.Higher score indicate greater limitations in activity. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting walking standing sitting, sleeping social life, traveling, employment/homemaking. Each topic is rated zero (no pain or no limitation) to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100% disability) and the best score is zero (0% disability).Change from baseline to month 6 is reported below, where a positive value represents the baseline value minus the month 6 value.|baseline and month 6|All available patients at six months were analyzed.|||units on a scale||95% Confidence Interval|Mean
1422580|NCT01076192|Secondary|Number of Participants With Serious Adverse Events (SAEs)|"SAEs are adverse event with any of the following severity criteria: Potentially fatal/endangers life, Hospitalisation or prolonging of hospitalisation, a medically important event that requires medical or surgical intervention to prevent a serious outcome, Disability or persistent incapacitation, death, congenital anomalies and/or miscarriage or abortion.~See the Reported Adverse Events Section for more details."|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.|||participants|||Number
1422581|NCT01076192|Primary|Percentage of Participants With Improvement From Baseline in Physician's Global Assessment (PGA)|The PGA was used to measure participants’ disease status at the time of assessment. This tool is a horizontal visual analogue 6-point scale measuring the degree of overall psoriatic lesion severity, and scores range from 0 (clear) to 5 (very severe). The percentage of patients who showed an improvement from baseline in their PGA scores is presented. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
1422640|NCT01075984|Primary|Steady State Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||ng/mL||Standard Deviation|Mean
1422582|NCT01076192|Primary|Mean Change From Baseline in Body Surface Area (BSA) Affected|Body Surface Area (BSA) affected or the psoriasis area is determined by the direct calculation of the affected body surface area. This determination was used to evaluate the effectiveness of the treatment during each of the study visits. The change was calculated by deducting the final score from the baseline score. Increased scores correspond to reduction of severity and reduction of BSA. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of body surface area||Standard Deviation|Mean
1422583|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of 100% (PASI 100)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 100 response is the percentage of participants who achieved a 100% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
1422584|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 90% (PASI 90)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
1422585|NCT01076192|Secondary|Number of Participants With Adverse Events of Special Interest (AESIs)|AESIs are adverse events of special interest, including infection, neoplasm, lupus-like, demyelinating disease, serious hepatic and/or haematological event.|From time of informed consent to the final visit after 2 years of observation|Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.|||participants|||Number
1422586|NCT01076192|Secondary|Mean Change From Baseline in Percentage of Lost Productivity Assessed Using Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|WPAI-SHP is a questionnaire used to evaluate lost productivity. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. Missing data were imputed using LOCF. n=the number of participants with data at each time point.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.|||units on a scale (a derived score)||Standard Deviation|Mean
1422587|NCT01076192|Secondary|Mean Change From Baseline in EuroQol Quality of Life Questionnaire (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Analysis included ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1422588|NCT01076192|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a self-administered Health Related Quality of Life (HRQL) questionnaire specifically for patients with dermatological diseases, adapted and validated in the Spanish population. It consists of 10 items with a Likert response scale for 4 categories and uses a 7 day time reference. It generates a global score that ranges from 0 (better HRQL) to 30 (worse HRQL) points. Change in DLQI was calculated by deducting the final score from the baseline score. Missing data were imputed using LOCF.|Baseline and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
1422589|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 75% (PASI 75)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
1422590|NCT01076192|Primary|Percentage of Participants Achieving a Reduction in PASI Score of at Least 50% (PASI 50)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI 50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. Missing data were imputed using LOCF.|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included ITT population with evaluable data.|||percentage of participants|||Number
1422610|NCT01076179|Primary|Prevalence of Adverse Events (Weeks 0-144), Per Participant|Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of participants|||Number
1422591|NCT01076192|Primary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI)|PASI is a measurement of the severity of psoriasis. It is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A lower (and negative) value of change indicates an increase in the severity of the psoriasis, while a positive value indicates an improvement in the severity of the PS. Missing data were imputed using last observation carried forward (LOCF).|Baseline, month 1 and every 3 months the first year and every 6 months up to month 24|Efficacy analyses included all participants who received at least 1 dose of adalimumab and had at least one follow-up visit (ITT) with evaluable data.|||units on a scale||Standard Deviation|Mean
1422592|NCT01076179|Other Pre-specified|Time to Virologic Failure|"Time to virologic failure was defined by the earliest occurrence of:~HIV-1 RNA > 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA < 50 copies/mL,~HIV-1 RNA > 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA < 50 copies/mL but subsequently did not have HIV-1 RNA > 400 copies/mL on 2 consecutive occasions, or~Day 1 if the participant never achieved HIV-1 RNA < 50 copies/mL during study participation.~A participant who prematurely discontinued study drug with HIV-1 RNA < 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c)."|Baseline (Week 0) to Week 144|Participants with an assessment|||weeks||Standard Error|Mean
1422593|NCT01076179|Other Pre-specified|Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load|Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||log copies/mL||Standard Deviation|Mean
1422594|NCT01076179|Secondary|Number of Participants With HIV-1 Coreceptor Tropism During Follow-up|Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.|up to Week 144|Since this was an observational study, resistance testing was performed at the discretion of the treating physician. No follow-up data on tropism was collected.||||||
1422595|NCT01076179|Secondary|Number of Participants With HIV-1 Coreceptor Tropism at Baseline|Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
1422596|NCT01076179|Secondary|Number of Participants With NRTI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
1422597|NCT01076179|Secondary|Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
1422598|NCT01076179|Secondary|Number of Participants With NNRTI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
1422599|NCT01076179|Secondary|Number of Participants With NNRTI Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
1422622|NCT01076075|Secondary|Change From Baseline in 2-hour Post-Meal Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.|||mg/dL||95% Confidence Interval|Least Squares Mean
1455519|NCT00811317|Secondary|Number of Hypoglycemic Events|This outcome captures the number of hypoglycemic events that occurred throughout the entire study|24 hours||||Number of events|||Number
1422600|NCT01076179|Secondary|Number of Participants With INI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment at follow-up (neither had available Baseline testing); since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
1422601|NCT01076179|Secondary|Number of Participants With INI Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
1422602|NCT01076179|Secondary|Number of Participants With PI Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Up to Week 144|Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
1422603|NCT01076179|Secondary|Number of Participants With Protease Inhibitor (PI) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.~Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
1422604|NCT01076179|Secondary|Number of Participants With LPV Resistance During Follow-Up|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|up to Week 144|Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.|||Participants|||Count of Participants
1422605|NCT01076179|Secondary|Number of Participants With Lopinavir (LPV) Resistance at Baseline|"Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.~Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). Susceptible indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. Partial resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). Resistant indicates that high level drug resistance has to be expected."|Baseline (Week 0)|Participants with an assessment at Baseline|||Participants|||Count of Participants
1422606|NCT01076179|Secondary|Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL||From Week 0 to Week 144|Participants with an assessment|||weeks||Standard Error|Mean
1422607|NCT01076179|Secondary|Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis|Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point.|||percentage of participants|||Number
1422608|NCT01076179|Secondary|Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis|Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method).|||percentage of participants|||Number
1422609|NCT01076179|Secondary|Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count|Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.|Baseline (Week 0) to Week 144|Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.|||cells/μL||Standard Deviation|Mean
1455520|NCT00811317|Secondary|Percentage of Time Spent With BG < 70 mg/dl||24 hours||||percentage of time||Standard Deviation|Mean
1422611|NCT01076179|Primary|Prevalence of Adverse Events (Weeks 0-144), Per Event|Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').|Weeks 0 to 144||||percentage of adverse events|Adverse Events||Number
1422612|NCT01076166|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.|||Participants|||Number
1422613|NCT01076166|Primary|Average Time From Baseline to Recovery From Fever and Other Symptoms|Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients.|||Days||Standard Deviation|Mean
1422614|NCT01076153|Secondary|Number and Type of Adverse Events|Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.|Baseline to 14 days|The safety population included all participants who took at least 1 dose of Klacid.|||Events|||Number
1422615|NCT01076153|Primary|Average Time From Baseline to Recovery From Cough and Other Symptoms|Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.|Baseline to 14 days|The per-protocol population consisted of 694 participants as 66 participants were excluded for protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).|||Days||Standard Deviation|Mean
1422616|NCT01076088|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for FPG. Last observation carried forward (missing data approach).|||mg/dL||95% Confidence Interval|Least Squares Mean
1422617|NCT01076088|Secondary|Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24|Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for 2-h PMG subsequent to at least 1 dose of study treatment, or lacked baseline data for 2-h PMG. Last observation carried forward (missing data approach).|||mg/dL||95% Confidence Interval|Least Squares Mean
1422618|NCT01076088|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1422619|NCT01076075|Primary|Number of Participants Discontinuing Study Drug Due to An Adverse Event||Week 0 to Week 54|The All Patients as Treated Population took at least 1 dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Participants discontinued due to adverse events are reported regardless of rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.|||participants|||Number
1422620|NCT01076075|Primary|Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54||Week 0 to Week 54|The All Patients as Treated Population took at least one dose of study drug. Participants received glycemic rescue medication if they met specific glycemic goals up to Week 24. Adverse events include those that occurred prior to a receiving rescue medication. Five participants were excluded from analyses due to 1 site's non-compliance.|||participants|||Number
1422621|NCT01076075|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24|Change from baseline reflects the Week 24 value minus the baseline value.|Baseline to Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.|||mg/dL||95% Confidence Interval|Least Squares Mean
1422638|NCT01075984|Primary|Steady State Maximum Concentration of IV Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||ng/mL||Standard Deviation|Mean
1422623|NCT01076075|Primary|Change From Baseline in Hemoglobin A1C (%) at Week 24|Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|The Full Analysis Set Population received at least one dose of study treatment and had baseline data and at least one post-baseline treatment endpoint observation for the analysis endpoint. Missing data were imputed using last observation carried forward (LOCF). Five participants were excluded from analyses due to one site's non-compliance.|||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1422624|NCT01076036|Primary|Procedural Technical Success|Successful robotic delivery and retraction of all PCI devices during CorPath PCI procedure.|Intervention|Total number of PCI devices.|||percentage of PCI devices|||Number
1422625|NCT01076036|Primary|Clinical Procedural Success|The percentage of Participants with <30% final diameter stenosis of the target lesion without in-hospital major adverse cardiovascular events (MACE) (defined as the composite of death, recurrent MI, and target vessel revascularization)|48-hrs or hospital discharge, whichever occurs first||||percentage of participants|||Number
1422626|NCT01075984|Primary|Steady State Apparent Total Body Clearance of Oral Posaconazole (CL/F)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|CL/F for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter||||||
1422627|NCT01075984|Primary|Steady State Average Concentration of Oral Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (12 hours).|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
1422628|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of Oral Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
1422629|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of Oral Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||Hours||Full Range|Median
1422630|NCT01075984|Primary|Steady State Maximum Concentration of Oral Posaconazole (Cmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 3, 5, 8 and 12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
1422631|NCT01075984|Primary|Steady State Trough Concentration of Oral Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after dosing on Day 7 (Cohort 0), or Day 28 (Cohorts 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
1422632|NCT01075984|Primary|Steady State Total Body Clearance of IV Posaconazole (CL)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|CL for posaconazole was not calculated in this study because it was collected in other studies more appropriate for evaluation of this parameter.||||||
1422633|NCT01075984|Primary|Steady State Average Concentration of IV Posaconazole (Cavg)|Blood samples were collected from participants for the determination of plasma POS concentration. Cavg was calculated as steady state AUC / dosing interval (24 hours).|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||ng/mL||Standard Deviation|Mean
1422634|NCT01075984|Primary|Steady State Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, 12, and 24 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||hour*ng/mL||Standard Deviation|Mean
1422635|NCT01075984|Primary|Single Dose Area Under the Concentration Versus Time Curve of IV Posaconazole (AUC)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
1422636|NCT01075984|Primary|Steady State Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 14 (Cohorts 1 and 2), or Day 10 (Cohort 3)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens.|||Hours||Full Range|Median
1422637|NCT01075984|Primary|Single Dose Time of Observed Maximum Concentration of IV Posaconazole (Tmax)|Blood samples were collected from participants for the determination of plasma POS concentration.|Predose and 1, 1.5, 1.75, 4, 8, and 12 hours after start of infusion on Day 1 (Cohorts 0 and 1)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||Hours||Full Range|Median
1422641|NCT01075984|Primary|Single Dose Trough Concentration of IV Posaconazole (Cmin)|Blood samples were collected from participants for the determination of plasma POS concentration.|12 hours after start of infusion on Day 1 (Cohorts 0, 1 and 2)|The PK-evaluable population included participants who had no major protocol violations and had documented adherence to the dosing and PK regimens. Cohort 3 was not evaluated for this outcome measure.|||ng/mL||Standard Deviation|Mean
1422642|NCT01075971|Primary|The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy.|"Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from Not at all satisfied (score = 0) to Totally satisfied (score = 10)."|Daily, Day 1 to Day 5||||Score on a scale||Standard Deviation|Mean
1422643|NCT01075958|Primary|Word Recognition (Episodic Memory)|The original 15 words plus 15 distractor words were presented one at a time in a random order. For each word the participant indicated whether or not it was included in the original list of words by pressing appropriate ‘yes’ and ‘no’ keys as quickly as possible. Stimuli remained on screen until an appropriate response had been made.|Single visit||||percent of correct responses||Standard Error|Mean
1422644|NCT01075958|Primary|Delayed Word Recall (Episodic Memory)|The participant was again given 60 seconds to write down as many of the words presented previously as possible.|Single visit||||Number of words recalled||Standard Error|Mean
1422645|NCT01075958|Primary|Immediate Word Recall (Episodic Memory)|A unique set of fifteen words is presented. Words were selected at random from a large bank of words derived from the MRC Psycholinguistic Database matched for word length, frequency, familiarity and concreteness. Stimulus duration was one second, as was the inter-stimulus duration. Following word presentation, the participant was allowed 60 seconds to write down as many of the words as possible.|Single visit||||Number of words recalled||Standard Error|Mean
1422646|NCT01075958|Primary|3-back Task (Working Memory)|A continuous string of letters (upper and lower case; inter-stimulus interval of 2.5 seconds) was presented; 45 letters in total with 15 target pairs. For each stimulus, participants were instructed to indicate whether this was the same letter that appeared three letters before.|Single visit||||percent of correct responses||Standard Error|Mean
1422647|NCT01075958|Primary|Corsi Blocks Span (Spatial Working Memory)|In this task nine identical blue squares appeared on screen in non-overlapping random positions. A set number of blocks changed colour from blue to red in a randomly generated sequence. Participants were instructed to repeat the sequence by clicking on the blocks using the mouse and cursor. The task was repeated five times at each level of difficulty. The sequence span increased from 4, until the participant could no longer correctly recall the sequence, resulting in a span measure of nonverbal working memory, calculated by averaging the level of the last five correctly completed trials.|Single visit||||Blocks remembered in sequence||Standard Error|Mean
1422648|NCT01075958|Primary|Alphabetic Working Memory (Working Memory)|Five random letters (A-Z) were presented sequentially for the participant to hold in memory. This was followed by a series of 30 probe digits (15 targets and 15 distractors) for each of which the participant indicated whether or not it had been in the original series by a simple key press. The task consisted of 3 separate trials.|Single visit||||percent of correct responses||Standard Error|Mean
1422649|NCT01075958|Primary|Numeric Working Memory (Working Memory)||Single visit||||percent of correct responses||Standard Error|Mean
1422650|NCT01075958|Primary|Four Choice Reaction Time (Attention)|A visual representation of the four direction arrow keys of a standard keyboard was presented on screen. The arrows ‘lit up’ at random on screen until the corresponding key press was made. In all, each arrow was the target stimulus 12 times, forming a total of 48 stimuli for this task in all.|Single visit||||ms||Standard Error|Mean
1422651|NCT01075958|Primary|Choice Reaction Time (Attention)|An arrow appeared on the screen pointing to the left or to the right. Participants responded with a left or right key press corresponding to the direction of the arrow. There was a randomly varying inter-stimulus interval of between 1 and 3 seconds for a total of fifty stimuli.|Single visit||||ms||Standard Error|Mean
1422652|NCT01075958|Secondary|Depression, Anxiety and Stress Scale (DASS)|The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Subjects are asked to use 4-point (0-3) severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress (0-42) are calculated by summing the scores for the relevant items, with higher scores indicating higher incidence of negative emotional symptoms. A total score can be derived by adding scores from each of the subscales (0-126).|Single visit-90 minutes||||Scores on a scale||Standard Deviation|Mean
1422653|NCT01075958|Primary|Simple Reaction Time (Attention)|The participant was instructed to press the ‘space bar’ on the laptop keyboard as quickly as possible every time an upwards pointing arrow appeared on screen. Fifty stimuli were presented with an inter-stimulus duration that varied randomly between 1 and 3.5 seconds.|Single visit|Only those participants for whom a venous blood sample was obtained (N=239) were entered into the analysis. A further 20 participants were excluded on the basis that their BMI exceeded 30, and could not be considered 'healthy individuals'.|||ms||Standard Error|Mean
1422654|NCT01075815|Secondary|Number of Cycles Cancelled Due to Risk of Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||cycles|||Number
1422655|NCT01075815|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
1422656|NCT01075815|Secondary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|Safety population included all participants who had received at least 1 dose of the study medication.|||participants|||Number
1422657|NCT01075815|Secondary|Total Number of Births|Total number of births per reporting group was calculated.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents number of participants evaluated for this measure."|||births|||Number
1422658|NCT01075815|Secondary|Number of Recombinant Human Choriogonadotropin (r-hCG) Cycles Cancelled Due to Poor Response|Poor response was defined as 3 or less follicles of greater than or equal to 12 mm developing following at least 7 days of study treatment.|Up to 2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||cycles|||Number
1422659|NCT01075815|Secondary|Number of Ovarian Stimulation Days|Ovarian stimulation included from first rFSH injection (S1) until day on which r-hCG was administered (r-hCG day). This period was divided into 2 parts: the first period in which 300 International Unit (IU) rFSH dose was constant and which covered from S1 to Day 4 of stimulation period (S4); the second period in which the rFSH dose could be adjusted depending on the ovarian response and which began on S4 and finished on the day on which the criteria for administration of r-hCG to induce the final follicular maturation were met.|S1 up to r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||Days||Standard Deviation|Mean
1422660|NCT01075815|Secondary|Estradiol (E2) Levels on r-hCG Day||r-hCG day (end of stimulation cycle [approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants with plasma E2 levels at r-hCG day."|||picogram/milliter (pg/mL)||Standard Deviation|Mean
1422661|NCT01075815|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH)||2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||IU||Standard Deviation|Mean
1422662|NCT01075815|Secondary|Number of Participants With Clinical Pregnancies|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
1422663|NCT01075815|Secondary|Number of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy.|2 months after OPU (34-38 hours post r-hCG day {end of stimulation cycle} [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||participants|||Number
1422664|NCT01075815|Secondary|Number and Quality of Embryos|Embryos were graded according to Spanish Association for the Study of Reproductive Biology (ASEBIR) criteria into different categories: (A) optimal quality with maximum capacity for implantation, (B) good quality with a high capacity for implantation, (C) regular with low possibility of implantation and (D) poor quality with very little possibility of implantation.|Day 2-3 post OPU (34-38 hours post r-hCG day {end of stimulation cycle}[approximately 28 days])|"ITT population included all randomized participants who had received at least 1 dose of the study medication. Here N represents the number of participants who had at least one fertilized oocyte."|||embyros|||Number
1422665|NCT01075815|Secondary|Number of Fertilized Oocytes (2 Pronuclei [PN])|Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of two 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||2PN oocytes|||Number
1422666|NCT01075815|Secondary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The nuclear maturity was evaluated based on the presence of a germinal vesicle (GV) or whether oocytes were in metaphase I (Meta-I) or II (Meta-II) stage.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||mature oocytes|||Number
1422667|NCT01075815|Secondary|Mean Number of Oocytes Retrieved|Mean number of oocytes retrieved per reporting group on the day of OPU (34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days]) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||oocytes||Standard Deviation|Mean
1422668|NCT01075815|Secondary|Mean Number of Follicles Greater Than or Equal to 14 Millimeter (mm) on Recombinant Human Choriogonadotropin (r-hCG) Day||r-hCG day (end of stimulation cycle [approximately 28 days])|ITT population included all randomized participants who had received at least 1 dose of the study medication.|||follicles||Standard Deviation|Mean
1422669|NCT01075815|Primary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred.|Day 35-42 post ovum pick-up (OPU) (34-38 hours post recombinant human choriogonadotropin day {end of stimulation cycle}[approximately 28 days])|Intention to treat (ITT) population included all randomized participants who had received at least 1 dose of the study medication.|||sacs per embryo||Standard Deviation|Mean
1422670|NCT01075763|Secondary|Global Deterioration Scale Score|Global deterioration scale includes seven different diagnostic stages ranging between “no cognitive deterioration” and “very serious cognitive deterioration”. It investigates the cognitive impairment. Scores range between 1 (no cognitive deterioration) and 7 (very severe cognitive decline).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422671|NCT01075763|Secondary|Geriatric Depression Scale (GDS) Score|The GDS consists of 30 'yes' or 'no' items aimed to assess depression. One point is assigned to each answer and the cumulative score is rated on a scoring grid. Scores are grouped as follows: 0-9 'normal', 10-19 'mildly depressed', and 20-30 'severely depressed'.|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422672|NCT01075763|Secondary|Clinician's Interview Based Impression of Change (CIBIC-PLUS) Score|CIBIC-PLUS: structured instrument based on comprehensive evaluation of 3 domains: participant cognition, behavior and functioning, including assessment of daily living activities. It includes 15 items and represents assessment of skilled clinician using validated scales based on the observation at interviews conducted separately with participant and caregiver familiar with behavior of participant. According to comparison between baseline and follow-up assessments, scores can range between 1 (markedly improved) and 7 (markedly worsened), with 4 indicating no change observed between two visits.|Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||participants|||Number
1422673|NCT01075763|Secondary|Physical Self-Maintenance Scale (PSMS) Score|PSMS designed as a disability measure for use in planning and evaluating treatment in elderly participants living in community or in institutions, is Guttman scale containing 6 items of self-care. The scale is based on theory that human behavior can be ordered in a hierarchy of complexity, within each category, a further hierarchy of complexity runs from basic to complex activities. It includes 6 items, testing the following areas: toilet use, eating, dressing, physical appearance, deambulation and bath. Scores range between 0 (excellent performance) and 30 (worst performance).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422674|NCT01075763|Secondary|Instrumental Activities of Daily Living (IADL) Score|IADL is used to evaluate participants with early-stage disease, both to assess level of disease and to determine participant's ability of self-care. IADL scale measures functional impact of emotional, cognitive, and physical impairments. It provides information about participants' compromising rate and care he might need. It includes 8 items: testing ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medication and ability to handle finances. Scores range between 0 (impairment) and 8 (full independence).|Baseline, Week 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422675|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Non-cognitive Subscale (ADAS-NonCog) Score|ADAS-NonCog is a subscale of ADAS aimed to evaluate the non-cognitive features such as mood state and behavioral changes. It takes about 10 minutes to be performed and includes 10 items: testing tearful, depressed mood, concentration/distractibility, uncooperative to testing, delusions, hallucinations, pacing, motor activity increase, tremors and appetite change. Scores range between 0 (excellent performance) and 35 (worst performance).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422676|NCT01075763|Secondary|Mini Mental Status Examination (MMSE) Score|MMSE is a tool for screening cognitive decline associated with dementia. It is a brief examination intended to evaluate an adult participant's level of cognitive functioning. The test is performed in following areas: orientation in time and place, learning and immediate recall, mental control and concentration, short-term recall, naming ability, language expression, verbal comprehension, writing comprehension, writing ability and visual-spatial coordination. Scores range between 0 (maximum cognitive deficit) and 30 (no cognitive deficit).|Baseline, Week 12, 28 and 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422677|NCT01075763|Secondary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Week 12 and 28|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422678|NCT01075763|Primary|Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) Score|ADAS: global rating scale created to evaluate both cognitive and functional aspects linked with disease progression. ADAS-Cog: subscale of ADAS which consists in a series of short tests aimed to evaluate possible cognitive impairment due to disease progression. It includes 11 items, testing word-finding difficulty, following commands, naming: objects and fingers, orientation, word recognition, recall of test instructions, constructions, ideational praxis, spoken language ability, comprehension of spoken language and word recall. Scores range from 0 (no impairment) to 70 (serious deficit).|Baseline and Week 52|Per protocol population included all participants who received treatments as scheduled and were followed up to week 52.|||units on a scale||Standard Deviation|Mean
1422679|NCT01075685|Secondary|Change in the Number of Excessive Drinkers|The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week|baseline and 6 weeks||||participants|||Number
1422757|NCT01075204|Secondary|Sputum Status at End of Study|Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.|10 days|Enrolled patients with sputum data available.|||participants|||Number
1422680|NCT01075685|Secondary|Category of Change in Weekly Alcohol Intake|"Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are:~clinically significant reduction in WAI, defined as a decrease of 10% or over;~clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0);~and no clinically significant change, which includes all other cases."|baseline and 6 weeks||||participants|||Number
1422681|NCT01075685|Secondary|Relative Change in Weekly Alcohol Intake|(6 weeks minus baseline)/baseline|baseline and 6 weeks|Participants with weekly alcohol consumption baseline at 0 were excluded from this analysis|||percent of baseline consumption||Standard Deviation|Mean
1422682|NCT01075685|Primary|Change in Weekly Alcohol Intake|"The unit of standard drink is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks."|baseline and 6 weeks|Only participants who completed the study were included in this analysis|||standard drinks||Standard Deviation|Mean
1422683|NCT01075646|Secondary|Contamination of the Catheter (Microbiologist Analysis)||at 48 hours||||participants|||Number
1422684|NCT01075646|Secondary|Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)||During 8-15 days||||participants|||Number
1422685|NCT01075646|Secondary|Secondary Effects Due to Morphine: Nausea and Vomiting||during 48 hours||||participants|||Number
1422686|NCT01075646|Secondary|Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.||7 Days (from Day 8-15)||||hours||Inter-Quartile Range|Median
1422687|NCT01075646|Secondary|Intensity of Pain Measured by Verbal Pain Scale.|Verbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.|At interval periods during 48 hours||||units on a scale||Inter-Quartile Range|Median
1422688|NCT01075646|Primary|Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System||48 hours||||mg||Inter-Quartile Range|Median
1422689|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.|Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
1422690|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)|Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up.|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
1422691|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.|Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
1422692|NCT01075412|Secondary|Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts|White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
1422693|NCT01075412|Secondary|Chemotherapy Compliance|The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.|post-treatment|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Participants|||Count of Participants
1422694|NCT01075412|Primary|Percent Difference From Baseline IMRT Plan (%)|The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation dose bins evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.|Baseline (pre-treatment)|Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).|||Percent difference (%)||Standard Deviation|Mean
1422695|NCT01075399|Primary|Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors|Primary tumor uptake of [F 18]HX4 was measured on PET images by onsite radiologist or nuclear medicine physician for 1st and 2nd PET scans. Values measured were: SUV (Standard Uptake Value), SUV Max (Maximum standard uptake value), SUV Mean (Mean standard uptake value), and T/B ratio (Tumor to background ratio). Pearson's correlation coefficient was calculated for each of the parameter.|Time between 1st and 2nd scan was 1 to 6 days|Based upon inclusion/exclusion criteria|||participants|||Number
1422696|NCT01075347|Secondary|Patients With Corneal Complications Due to Delayed Surface Re-epithelization (e.g. Infectious Corneal Ulcer, Corneal Melting, Sterile Corneal Ulcer, Corneal Neovascularization)||every day till total re-epithelization up to 14 days||||participants|||Number
1422697|NCT01075347|Primary|Patients With Corneal Epithelial Healing Time Within 14 Days|Patients were hospitalized and examined daily for graft re-epithelialization, which was the main outcome measure.Corneal epithelial healing(the process which the new corneal epithelial cells regenerated to cover the bare cornea lost of its epithelium, the cornea's outer layer) was recorded daily by slit-lamp examination with fluorescein staining.Patients with post-operative chronic persistent epithelial defects for >14 days after the operation were treated with therapeutic contact lens (TCL) application and followed up as outpatients.|every day till total re-epithelization up to 14 days||||participants|||Number
1422698|NCT01075282|Secondary|Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 26, 52, 78, and 83 weeks|Participants who received at least one dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
1422699|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG QTcF or PR Interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
1422700|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate|Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable ECG heart rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1422701|NCT01075282|Secondary|Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable blood pressure data.|||milliliter of mercury (mmHG)||Standard Error|Least Squares Mean
1422702|NCT01075282|Secondary|Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable sitting pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1422703|NCT01075282|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
1422704|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin||Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picogram/milliliter||Standard Deviation|Mean
1422705|NCT01075282|Secondary|Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
1440155|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||12 weeks after the first treatment|ITT|||Percent change from baseline||Standard Deviation|Mean
1422706|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units/liter||Inter-Quartile Range|Median
1422707|NCT01075282|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||participants|||Number
1422708|NCT01075282|Secondary|Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||events per participant per year||Standard Deviation|Mean
1422709|NCT01075282|Secondary|Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine.|||events|||Number
1422710|NCT01075282|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine. The number of participants with at least 1 TEAE is reported.|||participants|||Number
1422711|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey|The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable LBSS data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1422712|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1422758|NCT01075204|Secondary|Cough Status at End of Study|Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.|10 days|Enrolled patients with cough data available.|||participants|||Number
1423720|NCT01067105|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population.|||devices|||Number
1422713|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living|The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = “not at all difficult” and 1 = “unable to do”. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1422714|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1422715|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index|Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable BMI data.|||kilograms per square meter (kg/m^2)||Standard Error|Least Squares Mean
1422716|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Body Weight|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilogram (kg)||Standard Error|Least Squares Mean
1422717|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Glucagon Concentration|Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable glucagon data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
1422718|NCT01075282|Secondary|Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
1422719|NCT01075282|Secondary|Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles|The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable SMBG data. Only pre-rescue measurements were used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1422759|NCT01075204|Secondary|Fever Status at End of Study|Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.|10 days|All enrolled patients|||participants|||Number
1422720|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||participants|||Number
1422721|NCT01075282|Secondary|Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks|Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|26, 52, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||participants|||Number
1422722|NCT01075282|Secondary|Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, and 78 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percent||Standard Error|Least Squares Mean
1422723|NCT01075282|Primary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized and received at least one dose of LY2189265 or Insulin Glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1422724|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422725|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 3|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422726|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422727|NCT01075256|Other Pre-specified|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 10|ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422728|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422790|NCT01075100|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months|24 months|Evaluable population|||percentage of participants||95% Confidence Interval|Number
1422729|NCT01075256|Primary|Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15|Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422730|NCT01075256|Secondary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 7|ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422731|NCT01075256|Primary|Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.|Baseline to Day 15|Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.|||Units on a scale||95% Confidence Interval|Mean
1422732|NCT01075243|Secondary|Participants Global Assessment to Response to Treatment (PGART)|PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.|Baseline to 6 hours post dose|ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1422733|NCT01075243|Secondary|SPID Scores at 6 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422734|NCT01075243|Secondary|SPID Scores at 4 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422735|NCT01075243|Secondary|Sum of Pain Intensity Difference (SPID) Scores at 2 Hours|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422736|NCT01075243|Secondary|TOTPAR at 6 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422737|NCT01075243|Secondary|TOTPAR at 4 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422738|NCT01075243|Secondary|Total Pain Relief Score (TOTPAR) at 2 Hours|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet – timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Every two hours from baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422739|NCT01075243|Secondary|SPRID at 4 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 4 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422740|NCT01075243|Secondary|SPRID at 2 Hours|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief|Every two hours from baseline to 2 hours post dose|All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Score on a scale||Standard Deviation|Mean
1422741|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 6 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Percentage of participants|||Number
1422742|NCT01075243|Secondary|Percentage of Participants Who Took Rescue Medication at 2 Hours|Percentage of participants who received rescue medication at different time points post dose.|Baseline to 2 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||Percentage of participants|||Number
1422743|NCT01075243|Secondary|Time to Start Using Rescue Medication|Median time of use of rescue medication by participants.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.|||minutes||Full Range|Median
1422744|NCT01075243|Secondary|Time to Onset of Meaningful Pain Relief|Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
1422745|NCT01075243|Secondary|Time to Confirmed First Perceptible Relief|Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.|Baseline to 6 hours post dose|ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.|||minutes||Standard Deviation|Mean
1440156|NCT00933543|Primary|Absolute Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT|||lesions||Standard Deviation|Mean
1422746|NCT01075243|Primary|Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)|SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]|Every two hours from Baseline to 6 hours post dose|Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
1422747|NCT01075217|Secondary|The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The Investigator assessed all study images obtained for each patient using a 2-point scale (1 = adequate quality; 2 = inadequate quality); assessment was independent of factors or problems relating to the underlying patient condition or the imaging parameters selected.~Results are provided for patients with adequate quality."|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.|||participants|||Number
1422748|NCT01075217|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.|||participants|||Number
1422749|NCT01075217|Secondary|The Number of Participants With Significant Motion Artifacts (Scores of 3 or 4) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable. Scores of 3 and 4 were counted as significant motion artifacts.|Immediately postdose|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Patients with significant motion artifact were those with a score of 3 or 4 for motion artifacts in vessels distal to the knee|||participants|||Number
1422750|NCT01075217|Secondary|Level of Heat in the Lower Extremities Scored by Group 2 as Assessed on the Heat VAS Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Heat VAS was completed by the Group 2 patients to assess his/her heat level (separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no heat and the right end (10 cm) of the scale indicating the worst heat.~The Heat VAS was completed by the patient before completing the Pain VAS to assess pain."|Immediately after administration of agent using a power injector for the administration|Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Group 2 patients provided an assessment of heat by the Heat VAS prior to assessing pain by the Pain VAS.|||centimeters||Standard Deviation|Mean
1422751|NCT01075217|Primary|Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA|"The 10-centimeter Pain VAS was completed by the Group 1 patients to assess his/her pain level (not scoring heat separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.~The 10-centimeter Pain VAS (excluding Heat assessment, which was separately assessed) was completed by the Group 2 patients to assess his/her pain level in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain.~Group 1 completed the Pain VAS (heat not separate from pain). Group 2 completed the Pain VAS for pain only and, separately, the Heat VAS for heat only."|immediately after administration of agent using a power injector for the administration|Patients who received study agent, had the corresponding endpoint evaluations available and had no deviations from the planned protocol were included in the analysis.|||centimeters||Standard Deviation|Mean
1422752|NCT01075204|Secondary|Percentage of Participants Compliant With Treatment|Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.|10 days|All enrolled patients.|||percentage of participants|||Number
1422753|NCT01075204|Secondary|Post-nasal Discharge Status at End of Study|Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.|10 days|Enrolled patients with post-nasal discharge data available.|||participants|||Number
1422754|NCT01075204|Secondary|Rhinorrhea Status at End of Study|Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.|10 days|All enrolled patients|||participants|||Number
1422755|NCT01075204|Secondary|Abnormal Breathing Sounds Status at End of Study|Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.|10 days|All enrolled patients|||participants|||Number
1422756|NCT01075204|Secondary|Dyspnea Status at End of Study|Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.|10 days|All enrolled patients|||participants|||Number
1422760|NCT01075204|Primary|Classification of Overall Response|"Based on the participant and physician's assessment, overall symptom response was classified as follows:~Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment.~Slow Responders: participants showing clinical recovery between Day 6 & Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms).~Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms)."|10 days|All enrolled patients|||participants|||Number
1422761|NCT01075204|Primary|Percentage of Participants With Clinical Success|Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.|10 days|All enrolled patients.|||percentage of participants||95% Confidence Interval|Number
1422762|NCT01075204|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.~If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE):~Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.~Please see Adverse Events section below for more details."|10 days|All enrolled patients.|||participants|||Number
1422763|NCT01075204|Secondary|Factors Affecting the Speed of Recovery|Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.|10 days|All enrolled patients|||coefficient|||Number
1422764|NCT01075204|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.~Participants with treatment failure were further categorized as:~All symptoms improved but not resolved within the study period;~Some symptoms improved and some resolved;~Some symptoms resolved or improved while other symptoms did not improve (unchanged);~Some symptoms resolved or improved while other symptoms became worse."|10 days|All enrolled patients|||percentage of participants|||Number
1422765|NCT01075204|Primary|Percentage of Participants With a Fast Recovery|"Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment.~Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom."|Day 1 to Day 5|All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data.|||percentage of participants|||Number
1422766|NCT01075191|Secondary|Change From Baseline in CD4/CD8 T-cell Ratio|The CD4/CD8 T-cell ratio, also known as the T-lymphocyte helper/suppressor profile, presents the number of lymphocytes in the blood positive for CD4 cells compared with the number positive for CD8 cells. Changes in participants' CD4/CD8 T-lymphocyte ratio were assessed by measuring the change from Baseline in the ratio at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||ratio||Standard Deviation|Mean
1422767|NCT01075191|Secondary|Change From Baseline in Relative CD8 Cell Count|Decreases in relative CD8 count (the percentage of total lymphocytes that are CD8 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||percentage of cells||Standard Deviation|Mean
1422768|NCT01075191|Secondary|Change From Baseline in Absolute CD8 Cell Count|Decreases in CD8 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD8-positive (CD8+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD8+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||cells/µL||Standard Deviation|Mean
1422769|NCT01075191|Secondary|Change From Baseline in Relative CD4 Cell Count|Increases in relative CD4 count (the percentage of total lymphocytes that are CD4 cells) are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the percentage of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||percentage of cells||Standard Deviation|Mean
1422770|NCT01075191|Secondary|Change From Baseline in Absolute CD4 Cell Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||cells/µL||Standard Deviation|Mean
1422830|NCT01074944|Secondary|PAP: Mean Spleen Volume at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively.|||MN||Standard Deviation|Mean
1422771|NCT01075191|Primary|Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL|Viral load (number of HIV-1 RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments. The percentage of participants with HIV RNA less than 50 copies/mL at each time point is presented.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Evaluable participants. n=number of evaluable participants with given measurement at time point.|||percentage of participants|||Number
1422772|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Death|The number of subjects who died|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
1422773|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Arrhythmia|The number of subjects who experienced at least 1 event of arrhythmia meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
1422774|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection.|The number of subjects who experienced at least 1 event of infection meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
1422775|NCT01075178|Primary|Comparison Between CASES and CONTROLS of the Occurrence of Specific Clinical Outcomes of Serious Infection, Serious Arrhythmia and/or Death|The number of subjects who experienced at least 1 event of infection, arrhythmia, or death meeting any of the criteria for a serious adverse event|8-month chart review period in CASES and CONTROLS|The population analyzed included the full analysis set.|||participants|||Number
1422776|NCT01075152|Other Pre-specified|Percentage of Participants, Per CSF WBC Subgroup, Who Died by Week 26|Percentage of Participants who died by week 26 based on CSF white blood cell (WBC) count at study entry (time of randomization at a median of 8 days of anti-fungal therapy).|26 weeks|among persons with a measured CSF white cell count at randomization (Day 7-11 of amphotericin treatment)|||percentage of participants|||Number
1422777|NCT01075152|Secondary|Microbiologic Clearance|Microbiologic clearance of cryptococcus as measured by serial quantitative cryptococcal cultures collected at diagnosis through 14 days of amphotericin therapy. The early fungicidal activity (EFA) of the rate of clearance is expressed as log10 colony forming units (CFU) of Cryptococcus neoformans per mL of CSF per day.|4 weeks|All participants with >2 quantitative CSF cultures obtained|||log10 CFU/mL/day||95% Confidence Interval|Mean
1422778|NCT01075152|Secondary|Karnofsky Functional Status|"Functional status via Karnofsky performance status score at 4, 26, 46 weeks.~Karnofsky Scale:~100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment necessary.~10 - Moribund; fatal processes progressing rapidly. 0 - Dead"|46 weeks|Analysis is of persons alive at the time point.|||Scores on a scale||Standard Deviation|Mean
1422779|NCT01075152|Secondary|Antiretroviral Therapy Tolerability|Incidence of antiretroviral therapy interruption by >=3 consecutive days|26 weeks|Analysis is of persons who survived to initiate HIV therapy.|||participants|||Number
1422780|NCT01075152|Secondary|HIV-1 Viral Suppression|HIV-1 virologic suppression to <400 copies/mL at 26-weeks after enrollment|26 weeks|Among persons alive at 26 weeks. 1 participant in the early ART arm had consent withdrawn by their family on day 2 after study entry. 3 participants in the deferred ART arm missing their 26 week viral load sampling.|||participants|||Number
1422781|NCT01075152|Secondary|46-week Survival|46-week survival by time-to-event analysis of all subjects enrolled|46 weeks||||participants|||Number
1422782|NCT01075152|Secondary|Safety of ART Initiation|Incidence of Adverse Events (Grade 3,4,5) through 46-weeks, as defined by the National Institute of Allergy and Infectious Diseases, Division of AIDS toxicity classification scale, version 2009.|46 weeks||||participants|||Number
1422783|NCT01075152|Secondary|Incidence of Cryptococcal-relapse|Incidence of culture positive cryptococcal meningitis relapse|46 weeks||||participants|||Number
1422784|NCT01075152|Secondary|Incidence of Immune Reconstitution Inflammatory Syndrome|Incidence of cryptococcal-related immune reconstitution inflammatory syndrome through 46 weeks after enrollment.|46 weeks|analysis is of persons who survived to initiate HIV therapy|||participants|||Number
1422785|NCT01075152|Primary|Mortality|Intention to treat analysis of 26 week survival of all subjects enrolled. Reported below are the numbers of participants who died by Week 26.|26 weeks from study entry||||participants|||Number
1422786|NCT01075100|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.|30 months|Patients who achieved CR or PR.|||months||Full Range|Median
1422787|NCT01075100|Secondary|Time to Response|For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.|24 months|Patients who achieve a major objective response (CR or PR).|||months||Full Range|Median
1422788|NCT01075100|Secondary|Overall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|24 months|ITT population|||months||95% Confidence Interval|Median
1422789|NCT01075100|Secondary|Progression-free Survival (PFS)|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|24 months|ITT population|||months||95% Confidence Interval|Median
1422791|NCT01075100|Primary|Objective Response Rate (ORR)|"Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 months|Evaluable population|||percentage of participants||95% Confidence Interval|Number
1422792|NCT01075087|Secondary|24 Hour Total Opioid Consumption.|24 Hour total opioid consumption translated into IV morphine equivalents.|24 hours||||miligram IV morphine equivalents||Inter-Quartile Range|Median
1422793|NCT01075087|Primary|Quality of Recovery 40 Score|Quality of Recovery 40 Score at 24 hours postoperative.|24 hours post operatively||||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
1422794|NCT01075074|Secondary|Time to Hospital Discharge Readiness|Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge.|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||minutes||Inter-Quartile Range|Median
1422795|NCT01075074|Secondary|Opioid Pain Medications Consumed During the First 24 Hours Post Surgery|Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge|24 hours|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||mEq of PO morphine equivalent||Full Range|Mean
1422796|NCT01075074|Secondary|Pain Burden During Early Recovery From Anesthesia|Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable.|Post Operative|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||score on a scale * minutes||Inter-Quartile Range|Median
1422797|NCT01075074|Primary|The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery|The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.|24 hours after surgery|75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.|||units on a scale||Full Range|Median
1422798|NCT01074944|Secondary|LTTP: Mean Biomarker (MIP1-beta) Value at Baseline, 1 Year, and 2 Years|MIP1-beta biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||pg/mL||Standard Deviation|Mean
1422799|NCT01074944|Secondary|LTTP: Mean Biomarker (GL-1 on DBS) Value at Baseline, 1 Year, and 2 Years|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||mcg/mL||Standard Deviation|Mean
1422800|NCT01074944|Secondary|LTTP: Mean Biomarker (Chitotriosidase) Value at Baseline, 1 Year, and 2 Years|Chitotriosidase biomarker was assayed from plasma.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||nmol/hr/mL||Standard Deviation|Mean
1422801|NCT01074944|Secondary|LTTP: Total Bone Marrow Burden Score (BMB) at Baseline, 1 Year, and 2 Years|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||BMB Score||Standard Deviation|Mean
1422802|NCT01074944|Secondary|LTTP: Total Z-scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||Z-score||Standard Deviation|Mean
1422803|NCT01074944|Secondary|LTTP: Total T-Scores for BMD at Baseline, 1 Year, and 2 Years|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||T-score||Standard Deviation|Mean
1422804|NCT01074944|Secondary|LTTP: Bone Mineral Density (BMD) at Baseline, 1 Year, and 2 Years|BMD measurements of the spine and bilateral femur were acquired by DXA scan.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||g/cm^2||Standard Deviation|Mean
1422805|NCT01074944|Secondary|LTTP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, 1 Year, and 2 Years|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||participants|||Number
1422831|NCT01074944|Secondary|PAP: Mean Platelet Count at Baseline, Weeks 26, 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||platelets*10^9 /L||Standard Deviation|Mean
1422806|NCT01074944|Secondary|LTTP: Number of Participants With Bone Crises Assessment at Baseline, 1 Year and 2 Years|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crises, 1= 1 bone crisis during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, 1 year and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||participants|||Number
1422807|NCT01074944|Secondary|LTTP: Number of Participants With Mobility Status (MS) at Baseline, 1 Year and 2 Years|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, 1 year, and 2 years|All participants who received at least one dose of eliglustat during the LTTP.|||participants|||Number
1422808|NCT01074944|Secondary|LTTP: Percentage of Participants Who Maintained a Stable Bone Criterion ,Hemoglobin Level, Platelet Count, Liver Volume and Spleen Volume at 1 Year and 2 Years|Participant were considered as stable if they met the following criteria: hemoglobin level did not decrease >1.5 g/dL from baseline for PAP, platelet count does not decrease >25% below Baseline for PAP, liver volume does not increase >20% above Baseline for PAP, spleen volume does not increase >25% above Baseline for PAP. Baseline for PAP was defined as last available assessment prior to randomization.|1 Year, 2 Years|Analysis was performed on intent to treat (ITT) population which included all participants who received at least 1 dose of eliglustat after randomization. Here ‘n’ signifies number of participants with available data at specified time points.|||percentage of participants||95% Confidence Interval|Number
1422809|NCT01074944|Secondary|LIP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26, 52 and 78|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain. In this outcome, number of participants with different type of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.|||participants|||Number
1422810|NCT01074944|Secondary|LIP: Number of Participants With Bone Crises Assessment at Baseline, Weeks 26, 52 and 78|Bone crises was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crises, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, 2= 2 bone crises, 6= 6 bone crises, and 24= 24 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.|||participants|||Number
1422811|NCT01074944|Secondary|LIP: Number of Participants With Mobility Status (MS) at Baseline, Weeks 26, 52 and 78|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP.|||participants|||Number
1422812|NCT01074944|Secondary|LIP: Mean Biomarker (MIP1-beta) Value at Baseline, Week 78|MIP1-beta biomarker was assayed from plasma.|Baseline and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||pg/mL||Standard Deviation|Mean
1422813|NCT01074944|Secondary|LIP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26, Week 52, and Week 78|GL-1 on DBS biomarker was assayed from dried blood spot.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||mcg/mL||Standard Deviation|Mean
1422814|NCT01074944|Secondary|LIP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26, 52, and 78|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52 and Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||nmol/hr/mL||Standard Deviation|Mean
1422815|NCT01074944|Secondary|LIP: Mean Spleen Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.|||MN||Standard Deviation|Mean
1422816|NCT01074944|Secondary|LIP: Mean Liver Volume at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT participants which included all participants who received at least 1 dose of eliglustat during lead in period. Here, 'n' signifies number of participants with available data at specified time points.|||MN||Standard Deviation|Mean
1422817|NCT01074944|Secondary|LIP: Mean Platelet Count at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week 52, Week 78|Analysis was performed on AT analysis set which included all participants who received at least 1 dose of eliglustat during LIP. Here ‘n’ signifies number of participants with available data at specified time points.|||platelets*10^9 /L||Standard Deviation|Mean
1422818|NCT01074944|Secondary|LIP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26, 52 and 78||Baseline, Week 26, Week, 52, and Week 78|Analysis was performed on all treated (AT) analysis set which included all participants who received at least 1 dose of eliglustat during lead in period. Here 'n' signifies number of participants with available data at specified time points.|||g/dL||Standard Deviation|Mean
1422819|NCT01074944|Secondary|PAP: Total Bone Marrow Burden Score (BMB) at Baseline and Week 52|BMB Score was measured using magnetic resonance imaging (MRI), range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0 (no abnormalities) -16 (severe disease) points. A higher BMB score signified more severe bone marrow involvement.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.|||BMB Score||Standard Deviation|Mean
1422820|NCT01074944|Secondary|PAP: Number of Participants With Bone Pain Levels During the Past 4 Weeks at Baseline, Weeks 26 and 52|Bone pain was assessed as a part of Gaucher disease assessment in participants. Participants were categorized as none (no bone pain), very mild bone pain, mild bone pain, moderate bone pain, severe bone pain and extreme bone pain during the past 4 weeks. In this outcome, number of participants with different level of bone pain during the past 4 weeks at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||participants|||Number
1422821|NCT01074944|Secondary|PAP: Number of Participants With Bone Crises at Baseline, Weeks 26 and 52|Bone crisis was assessed as a part of Gaucher disease assessment in participants. Acute, excruciating episodic bone pain is characteristic of Gaucher bone crisis, which typically causes debilitation lasting several days or longer and requires treatment with immobilization, hydration, and opioid analgesics. Participants were categorized as 0= no bone crisis, 1= 1 bone crisis, and 2= 2 bone crises during the assessment period. In this outcome, number of participants with different bone crises levels at specified time points were reported.|Baseline, Week 26, and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||participants|||Number
1422822|NCT01074944|Secondary|PAP: Number of Participants With Mobility Status Asessments (MS) at Baseline, Weeks 26, and 52.|Mobility, i.e., ability to walk was assessed as a part of Gaucher disease assessment in participants. In this outcome, number of participants with their different mobility status along with the use of mobility aids (unrestricted mobility, walks with difficulty, walks with orthopaedic aid, requires wheelchair, bedridden) at specified time points were reported.|Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||participants|||Number
1422823|NCT01074944|Secondary|PAP: Total Z-scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data for specified category for each arm respectively|||Z-score||Standard Deviation|Mean
1422824|NCT01074944|Secondary|PAP: Total T-Scores for BMD at Baseline and Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. The T-score bone density categories were: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5).|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||T-score||Standard Deviation|Mean
1422825|NCT01074944|Secondary|PAP: Bone Mineral Density (BMD) at Baseline and Week 52|BMD measurements of the spine and bilateral femur were acquired by dual-energy x-ray absorptiometry (DXA) scan.|Baseline, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data at specified time points for each arm respectively.|||g/cm^2||Standard Deviation|Mean
1422826|NCT01074944|Secondary|PAP: Mean Biomarker Macrophage Inflammatory Protein-1 Beta (MIP1-beta) Value at Baseline, Weeks 26, 52|MIP1-beta biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.|||pg/mL||Standard Deviation|Mean
1422827|NCT01074944|Secondary|PAP: Mean Biomarker (GL-1 on DBS) Value at Baseline, Week 26 and Week 52|GL-1 on DBS biomarker was assayed from dried blood spot (DBS).|Baseline, Week 26 and week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||mcg/mL||Standard Deviation|Mean
1422828|NCT01074944|Secondary|PAP: Mean Biomarker (Chitotriosidase) Value at Baseline, Weeks 26 and Week 52|Chitotriosidase biomarker was assayed from plasma.|Baseline, Week 26, Week 52|PP population which all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here, 'n' signifies number of participants with available data for specified category for each arm respectively.|||nmol/hr/mL||Standard Deviation|Mean
1422829|NCT01074944|Secondary|PAP: Mean Liver Volume at Baseline, Weeks 26, 52||Baseline, Week 26 and Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||MN||Standard Deviation|Mean
1422832|NCT01074944|Secondary|PAP: Mean Hemoglobin (Hb) Level at Baseline, Weeks 26 and 52||Baseline, Week 26, Week 52|PP population included all participants who were at least 80% compliant with IMP dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations. Here 'n' signifies number of participants with available data at specified time points for each arm respectively.|||g/dL||Standard Deviation|Mean
1422833|NCT01074944|Primary|PAP: Percentage of Participants Who Remained Stable for 52 Weeks During the PAP|Participants were considered as stable if they met all of the following criteria: 1) no more than 2 bone crisis during PAP (with no more than 1 bone crisis during either the first 6 months or the later 6 months of the period), and were free of other clinically symptomatic bone disease during the entire 52-week PAP; 2) hemoglobin level not decreased >1.5 g/dL from Baseline for PAP; 3) platelet count not decreased >25% from Baseline for PAP; 4) spleen volume (in multiples of normal [MN]) did not increase >25% from Baseline for PAP; 5) liver volume (in MN) did not increase >20% from Baseline for PAP. Baseline for PAP was defined as the last assessment prior to randomization.|PAP Baseline up to the end of PAP (Week 52)|Analysis was performed on per protocol (PP) population which included all participants who were at least 80% compliant with investigational medicinal product (IMP) dosing during PAP, had all of the necessary Baseline and Week 52 assessments to evaluate the primary endpoint, and did not have major protocol deviations.|||percentage of participants||95% Confidence Interval|Number
1422834|NCT01074931|Secondary|The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment|As so few participants withdrew from lopinavir/ritonavir treatment, durations of lopinavir/ritonavir therapy required for 25 percent, 50 percent and 75 percent of participants could not be established. The numbers of participants in each subgroup who discontinued from treatment due to an adverse event are presented.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.|||Participants|||Number
1422835|NCT01074931|Secondary|Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations|The types of adverse events reported are summarized. The presence of lipodystrophy (abnormal body fat distribution) and its location was to be recorded. However, due to an oversight, there was not a place to record the location of lipodystrophy on the case report form. Doctors used clinical judgment to rate lipodystrophy in treatment-experienced participants. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|The adverse event population includes all participants who took at least one dose of lopinavir/ritonavir (98). Lipodystrophy evaluations were performed in treatment-experienced participants (90), not treatment-naive participants (8).|||Participants|||Number
1422836|NCT01074931|Secondary|Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen|Visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The frequency with which each participant forgot to take their medication since the last visit and discontinuations of treatment and the reasons were documented at each visit and are summarized. The number of participants changing from lopinavir/ritonavir soft gel capsule to tablet are also presented. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month. Note: participants may have had multiple missed doses or therapy changes.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir.|||Participants|||Number
1422837|NCT01074931|Primary|Evolution of the Tolerance Issues|At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants taking at least one dose of lopinavir/ritonavir.|||Participants|||Number
1422838|NCT01074931|Primary|Evolution of CD4 Count|The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|Includes all participants taking at least one dose of lopinavir/ritonavir who had CD4+ count results at each particular time point.|||cells per cmm||Standard Deviation|Mean
1422839|NCT01074931|Primary|Evolution of the HIV Viral Response|The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician’s judgment, so data are reported for Visits 1 through 4 rather than by month.|Month 3, 6, 12, 18|All participants who took at least one dose of lopinavir/ritonavir and had HIV viral load testing.|||participant|||Number
1422840|NCT01074658|Secondary|Percentage of Participants With Procedural Success|Procedural success, defined as device success with absence of in-hospital MACCE|up to 30 days|All attempted population in which the separate variables related to procedural success (see outcome measure description) were analyzable.|||percentage of participants|||Number
1422841|NCT01074658|Secondary|Percentage of Participants With Device Success|"Device Success is defined as a composite of:~Successful device delivery;~Stable device placement;~Intact retrieval of delivery catheter;~Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation"|up to 24 hours|All attempted population in which the separate variables related to device success (see outcome measure description) were analyzable.|||percentage of participants|||Number
1425206|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1422843|NCT01074554|Secondary|Change in Modified Sarcoidosis Activity and Severity Index (SASI) at Completion of Therapy.|Characterization of lesion severity was conducted using Modified Sarcoidosis Activity and Severity Index (SASI), measuring erythema, induration and desquamation. The modification was that the same scale was applied to any part of the body, instead of the face alone. The scale range is 0 (no problem) to 72 (very severe).|Baseline to 8 weeks||||units on a scale||Standard Deviation|Mean
1422844|NCT01074554|Primary|Granuloma Burden|Number of patients with a decrease in Granuloma Burden (only in those patients having granulomas present at baseline biopsy)|Baseline to 8 weeks||||participants|||Number
1422845|NCT01074554|Primary|Change in Lesion Size at the Completion of Antibiotic Therapy, Measured on a Continuous Scale; Change Will be Determined by Change in Diameter of the Lesions||Baseline to 8 weeks||||mm||Standard Deviation|Median
1422846|NCT01074502|Primary|Percentage of Patients Achieving a Clear or Almost Clear PGA at 16 Weeks||Baseline to 16 weeks|||||||
1422847|NCT01074502|Secondary|Safety of Apremilast 20 Mgs BID for 12 Weeks Will be Assessed by Evaluating Adverse Events (AEs), Vital Signs, Laboratory Evaluations and Withdrawals From the Study|Number of participants with adverse events|Baseline to 16 weeks|||||||
1422848|NCT01074502|Secondary|The Absolute Change in Lesion Counts (Total, Inflammatory, Non-inflammatory) From Baseline to Week 12||Baseline to12 weeks|||||||
1422849|NCT01074502|Primary|Mean Percentage Change From Baseline in Individual Lesion Counts (Total, Inflammatory, Non-inflammatory) at Week 12||Baseline to 12 weeks|||||||
1422850|NCT01074502|Primary|Percentage of Patients With a Minimum 2-grade Improvement in the Researcher Global Assessment (RGA) From Baseline to Week 12.|RGA measures the severity of acne. The scale goes from 0 (better)to 4 (worse). Score can only be whole numbers, ordinal.|Baseline to 12 weeks|small number of subjects to be analyzed||||||
1422851|NCT01074502|Primary|Percentage of Patients With a Success Rate (Based on the Researcher's Global Assessment (RGA) Sum of Clear (0) or Almost Clear (1))|RGA measures the severity of acne. The scale goes from 0-4. 0 will be better and 4 will be worse. Scores can only be whole numbers (0,1,2,3,4)ordinal.|Baseline to 16 weeks|small number of subjects to analyze||||||
1422852|NCT01074463|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1422853|NCT01074463|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1422854|NCT01074463|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1422855|NCT01074450|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1422856|NCT01074450|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1422857|NCT01074450|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1422858|NCT01074437|Primary|Lesion Regression|measure of change in lesion area or volume|12 months|Insufficient enrollment for data analysis to be meaningful.||||||
1422859|NCT01074437|Secondary|Demonstrate How Duplex Scanning to Assess Blood Vessel Density and Qualitative Color Ratings of Cutaneous Lesions From Photographs Can be Used to Measure and Quantify Changes in IH Size and Vascularity in a Clinically Relevant Manner.||1, 2 and 6 months after treatment initiation|||||||
1422860|NCT01074437|Secondary|Assess the Safety of Propranolol With Corticosteroids and Corticosteroids Alone in the Treatment of IH.||1, 2 and 6 months after treatment initiation|||||||
1422861|NCT01074437|Secondary|Determine Therapeutic Response of IH to Propranolol Among Patients Who Switch to Corticosteroids Plus Propranolol Therapy After Failing to Respond to Corticosteroids Alone.||1, 2, and 6 months after treatment initiation|||||||
1422862|NCT01074437|Primary|Compare Changes in IH Size and Vascularity for Subjects Randomized to Receive Initial Treatment With Corticosteroid-only Therapy Versus Combination Therapy With Corticosteroids Plus Propranolol||1, 2, and 6 months after treatment initiation|||||||
1422863|NCT01074307|Secondary|Mean Change From Baseline in Global Assessment of Congestive Heart Failure (CHF) Score at Week 26|Global assessment of CHF: The Investigator defined, graded, and recorded the participant’s symptoms and signs by using a 6-point CHF scale ranging from 0 (unassessable), 1 (worsened), 2 (no change), 3 (mildly improved), 4 (moderately improved) and 5 (markedly improved).|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Units on a scale||Standard Deviation|Mean
1422864|NCT01074307|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Baseline up to Week 26|Safety analysis population included all the randomized participants who had at least one dose of the investigational product had post-dose safety data confirmed at least once by the Investigator.|||Participants|||Number
1422865|NCT01074307|Secondary|Number of Participants Who Were Re-hospitalized Due to Heart Failure and Who Died Due to Cardiovascular Disorder||Baseline up to Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.|||Participants|||Number
1422866|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Size at Week 26|Left ventricle size was measured as systolic and diastolic Left Ventricular Internal Dimension (LVID). Diastolic dimension was measured of the left ventricle at the level of the chordae tendineae. The systolic dimension was measured as the smallest dimension between the left septal endocardium and the posterior wall endocardium during systole, whether or not the two walls were exactly apposed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Milliliter LVID||Standard Deviation|Mean
1422867|NCT01074307|Secondary|Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Week 26|LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Percent LVEF||Standard Deviation|Mean
1422868|NCT01074307|Secondary|Change From Baseline in 6-minute Walking Test (6-MWT) Distance at Week 26|6-minute Walking Test (6-MWT) distance was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||Meter||Standard Deviation|Mean
1422869|NCT01074307|Secondary|Percentage of Participants Classified as Class I to IV According to New York Heart Association (NYHA)|New York Heart Association (NYHA) classification of heart failure: Class I: No limitation: ordinary physical exercise does not cause undue fatigue, dyspnea, or palpitations. Class II: Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations, or dyspnea. Class III: Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms. Class IV: Unable to carry out any physical activity without discomfort: symptoms of heart failure are present even at rest with increased discomfort with any physical activity.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product.|||Percentage of participants|||Number
1422870|NCT01074307|Primary|Percent Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26|B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. The percent change of NT-pro BNP was calculated according to the formula: N-terminal pro B-type natriuretic peptide (NT-proBNP) reduction ratio = 100*(Baseline NT-proBNP - Week 26 NT-proBNP)/Baseline NT-proBNP.|Baseline and Week 26|ITT population included all the randomized participants who had at least one dose of the investigational product. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Percent change||Standard Deviation|Mean
1422871|NCT01074268|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect or important medical issues|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Events/100 years of patient exposure|||Number
1422872|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1422873|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L with or without symptoms|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1422887|NCT01074216|Primary|To Achieve Target Vitamin D Level|To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks|Within 6 weeks of beginning vitamin D||||participants|||Number
1440157|NCT00933543|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)||12 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
1422874|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1422875|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1422876|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.|||mmol/L||Standard Deviation|Mean
1422877|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.|||mmol/L||Standard Deviation|Mean
1422878|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 4 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1422879|NCT01074268|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.|Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 5 subjects, all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1422880|NCT01074268|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1422881|NCT01074268|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1422882|NCT01074255|Primary|Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy|The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).|Up to 14 days following the cessation of treatment|The Efficacy Evaluable Population consisted of participants treated with EMEND for 3 days and assessed by an investigator for efficacy. Participants were excluded from efficacy analysis for having a EMEND administration period less than 3 days (143 participants) or unavailability of final efficacy evaluation (1 participant).|||participants|||Number
1422883|NCT01074242|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis|||Percent of participants|||Number
1422884|NCT01074242|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days after any Rotateq vaccination|All enrolled participants who received at least 1 dose of study vaccine were included in the analysis|||Percent of participants|||Number
1422885|NCT01074229|Secondary|24 Total Morphine Consumption|Total 24 total morphine consumption post operative.|1 day||||miligrams of morphine||Standard Deviation|Mean
1422886|NCT01074229|Primary|QoR40 on the Day After Surgery|QoR40 on the day after surgery. Quality of recovery is based on a score of 40-200. 40 being a poor recovery and 200 being a good recovery score.|1 day||||units on a scale||Inter-Quartile Range|Median
1440158|NCT00933543|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count||6 weeks after the first treatment|ITT|||percent change from baseline||Standard Deviation|Mean
1422888|NCT01074177|Secondary|Number of Participants With Biopsy Complications From Repeat Tumor Biopsies|The number of participants with biopsy complications from repeat tumor biopsies taken following disease progression. Biopsy complications are any adverse events considered to be potentially related to the biopsy.|7 days post biopsy and ≥ 30 days post-biopsy||||Participants|||Count of Participants
1422889|NCT01074177|Secondary|Median Progression-free and Overall Survival|The progression-free and overall survival times. Overall survival is measured from the start of treatment until the time of death or until the participant is lost to follow-up. Progression free survival is measured from the start of treatment until the time of progression, death, or until the participant is lost to follow-up (whichever occurs first). Progression is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.|start of treatment, at the time of disease progression, time of death||||Months||95% Confidence Interval|Median
1422890|NCT01074177|Secondary|Response Rate|"The number of participants with either a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)~CR: Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Baseline and then after the end of every two 28 day cycles until treatment is discontinued; median duration of followup of 19.3 months||||participants|||Number
1422891|NCT01074177|Primary|Number of Participants That Have a T790M Mutation on Their Progression Biopsy.||At the time of disease progression (median duration of 11.4 months from start of treatment)|The 14 participants that experienced disease progression and were also eligible to be biopsied.|||Participants|||Count of Participants
1422892|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the lichenification subscale score, lichenification is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
1422893|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the excoriation subscale score, excoriation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
1422894|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the infiltration/papulation subscale score, infiltration/papulation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
1422895|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the erythema subscale score, erythema is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
1422907|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||hospitalizations per patient year|||Number
1422896|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score|"The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining area subscale score, the percent area of skin involvement is determined and assigned a score of 0 to 6, where 0 correlates with no skin involvement, 1 represents < 10% skin involvement, 2 represents 10-29% skin involvement, 3 represents 30-49% skin involvement, 4 represents 50-69% skin involvement, 5 represents 70-89% skin involvement, and 6 represents 90-100% skin involvement. Possible scores range from 0 to 6, where 0 correlates with better disease severity and 6 correlates with worse disease severity.~Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18."|Baseline and 4 weeks||||units on a scale||Full Range|Median
1422897|NCT01074164|Secondary|Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score|The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.|Baseline and 4 weeks||||units on a scale||Full Range|Mean
1422898|NCT01074164|Primary|Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score|The VAS score assesses itch intensity in subject’s with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled “Least Itch,” and the right boundary vertical line is labeled “Worst Itch.” Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity.|Baseline and 4 weeks||||centimeters||Full Range|Mean
1422899|NCT01074125|Secondary|Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment|proportion was calculated separately for each treatment arm|Baseline and day 28|Intent-to-Treat|||% of Participants|||Number
1422900|NCT01074125|Secondary|Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment|Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.|Baseline and day 28|Intent-to-Treat, includes only subjects that had both baseline and end of study actual values|||mg/dL||Standard Deviation|Mean
1422901|NCT01074125|Primary|Change in Serum Phosphorus From Baseline to End of Treatment|Mean change from baseline was calculated separately for each treatment arm (LOCF)|Baseline and day 28|Intent to Treat (ITT) Population|||mg/dL||Standard Deviation|Mean
1422902|NCT01074099|Primary|Safety|as measured by frequency and severity of adverse events|through 1 Year post tx||||participants|||Number
1422903|NCT01074099|Primary|Change in Cardiac Status (Classification)|A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation|Through 12 months post treatment|Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.||||||
1422904|NCT01074047|Secondary|Number of Participants in the Extension Phase With Treatment Emergent Adverse Events (TEAEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild – transient or mild discomfort; no medical intervention required; Grade 2 = Moderate – mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From the date of informed consent for the Extension Phase through to the date of last dose of study drug + 28 days up to last visit completed 24 July 2016; maximum duration of exposure to Azacitidine was 871 days|Safety population includes those enrolled in the extension phase who received at least one dose of study drug.|||participants|participants||Number
1422905|NCT01074047|Secondary|HRU: Rate of Transfusions Per Patient Year|HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective. The rate of transfusions per patient year was calculated as the total number of transfusions divided by the total number of patient-years followed in the study period. Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||transfusions per patient year|||Number
1422906|NCT01074047|Secondary|HRU: Number of Participants Receiving Transfusions|Count of study participants who had transfusions during the treatment phase. HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||participants|||Number
1440898|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >3 to 6 Months After Initiation||>3 to 6 months after initiation|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1422908|NCT01074047|Secondary|Healthcare Resource Utilization (HRU): Number of Inpatient Hospitalizations|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Day 1 (randomization) to 40 months|HRU was analyzed for the HRQoL Evaluable Population, a smaller sample than either the ITT population or safety population. Duration of therapy differed between treatment groups. Rate-per-patient year values adjust for these differences.|||participants|||Number
1422909|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422910|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422911|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422912|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422913|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Global Health Status-/Quality of Life Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422914|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422915|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422916|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422917|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422918|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 PhysicalFunctioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422919|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to end of study, at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422920|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. The analysis included 157 from the azacitidine group and 134 in the CCR group, a smaller number than the ITT population.|||units on a scale||Standard Deviation|Mean
1422933|NCT01074047|Secondary|Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)|Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi were censored at the date of their last response assessment.|Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months|Participants who achieved a CR or CRi|||months||95% Confidence Interval|Median
1422921|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422922|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422923|NCT01074047|Secondary|HRQoL: Change From Baseline in the EORTC QLQ-C30 Dyspnea|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom).|Baseline to Cycle 3, at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422924|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to End of Study; at approximately 11-12 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422925|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 9, at approximately 9 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population. .|||units on a scale||Standard Deviation|Mean
1422926|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 7, at approximately 7 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1425748|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||Baseline|||||||
1422927|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 5, at approximately 5 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422928|NCT01074047|Secondary|Health Related Quality of Life (HRQoL): Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Domain|The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline to Cycle 3; at approximately 3 months|The HRQoL Evaluable population included only participants with a baseline QoL assessment and at least 1 follow-up assessment. Time windows were applied post-hoc to increase the size of the analyzable population.|||units on a scale||Standard Deviation|Mean
1422929|NCT01074047|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild – transient or mild discomfort; no medical intervention required; Grade 2 = Moderate – mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017|Safety population = all randomized participants who received at least 1 dose of study drug and had 1 post-dose safety assessment. Because the BSC only regimen consisted of blood products or antibiotics given as needed, those assigned to BSC only were included in the safety population if they had at least 1 post-randomization safety assessment.|||participants|||Number
1422930|NCT01074047|Secondary|Number of Participants Who Achieved a Cytogenetic Complete Response (CRc-10) as Determined by the IRC.|The CRc is a normal karyotype defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) is when the following criteria are met: 1) CR criteria met and 2) an abnormal karyotype is present at baseline and 3) there is reversion to normal karyotype at the time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||participants|||Number
1422931|NCT01074047|Secondary|Duration of Remission Assessed by the IRC Based on Kaplan-Meier Estimates|The time from the date CR or CRi was first documented until the date of documented relapse from CR/CRi. Duration of remission was defined only for those participants who achieved a CR or CRi, as determined by the IRC. Participants who were lost to follow-up without documented relapse, or were alive at last follow-up without documented relapse were censored at the date of their last response assessment.|Day 1 (randomization) to 40 months; date of the first documented CR or CRi until date of first documented relapse.|Includes those who achieved a CR or CRi and assessed by the IRC; numbers of ITT participants in each treatment group|||months||95% Confidence Interval|Median
1422932|NCT01074047|Secondary|Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)|A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as <5% BM blasts with the ANC count < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||percentage of participants|||Number
1422966|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422934|NCT01074047|Secondary|Event-free Survival (EFS)|Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.|Day 1 (randomization) to date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||months||95% Confidence Interval|Median
1422935|NCT01074047|Secondary|One-year Overall Survival Rate|Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|From Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||percentage of participants||95% Confidence Interval|Number
1422936|NCT01074047|Primary|Kaplan-Meier Estimates for Overall Survival|Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.|Day 1 (randomization) to 40 months|The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored|||months||95% Confidence Interval|Median
1422937|NCT01074034|Secondary|Conversion Success Rate up to Three Months Post-implant|For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.|Three months post-implant||||% of conversion rates|||Number
1422938|NCT01074034|Primary|Inappropriate Shock Free Rate|Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.|Three months post-implant||||% of shock free rates|||Number
1422939|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Mental Component Summary (MCS)|The Mental Component Summary (MCS) of the SF-36 was used to measure the overall mental health status of participants. The aggregated score of the SF-36 MPS was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better mental function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
1422940|NCT01074008|Other Pre-specified|Change From Baseline in SF-36 Physical Component Summary (PCS)|The Physical Component Summary (PCS) of the SF-36 was used to measure the overall physical health status of a participant. The aggregated score of the SF-36 PCS score was standardized using a linear T-score transformation with a mean of 50 and a standard deviation of 10; a higher score indicated better physical function and well-being. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
1422941|NCT01074008|Other Pre-specified|Change From Baseline in EQ-5D (3 Level) Health Index Score|The EQ-5D was a health state questionnaire used to measure five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The combination of responses from all five dimensions were derived into an index score ranging from 0 to 1; a higher score indicated a more preferable health utility value from the societal perspectives. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
1422942|NCT01074008|Other Pre-specified|Change From Baseline in ED-5D Visual Analog Scale (ED-5D VAS) Score|The ED-5D VAS was a self-rating survey used to capture the current health status of a participant and ranged from 0 (the worst imaginable health state) to 100 (best imaginable health state). Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are presented as the group mean change from baseline ± standard deviation.|Baseline and Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
1422967|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422943|NCT01074008|Other Pre-specified|Change From Baseline in Hepatitis C Virus Patient-reported Outcomes (HCV-PRO) Total Score|The Hepatitis C Virus Patient-report Outcomes (HCV-PRO, formerly known as HCV Quality of Life) survey was used to assess disease-specific function and well-being on a scale from 0 to 100; a higher score indicated relatively good function and well-being of treated participants. Data presented are the summaries across all participants, for each treatment arm, regardless of dose. Data are reported as the group mean change from baseline ± standard deviation.|Baseline up to Post-treatment Week 24|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||units on a scale||Standard Deviation|Mean
1422944|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-333 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-333 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-333 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.|||participants|||Number
1422945|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-072 in Non-structural Viral Protein 5B (NS5B)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-072 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for the presence of resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-072 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.|||participants|||Number
1422946|NCT01074008|Other Pre-specified|Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to ABT-450 in Non-structural Viral Protein 3 (NS3)|Baseline samples were analyzed for resistance-associated amino acid variants using population and clonal sequencing and were compared with the appropriate reference sequence (1a-H77 or 1b-Con1). Phenotypic resistance to ABT-450 at baseline was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Available samples at Day 4 with HCV RNA ≥ 1000 IU/mL were analyzed for resistance-associated variants using population and clonal sequencing and were compared with the baseline sequences to assess amino acid changes. Phenotypic resistance to ABT-450 at Day 4 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding baseline sample. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance are presented.|Baseline and Day 4|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the analysis. When the number of participants used to analyze the data at a specific time point differs from the Number of Participants Analyzed, the n (number of participants) is denoted in the Category Title.|||participants|||Number
1422947|NCT01074008|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Complete EVR was defined as HCV RNA levels < LLOQ (< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.|Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and have at least one post-baseline measurement of HCV RNA levels.|||percentage of participants|||Number
1422948|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours) and at 2, 4, 8, and 12 hours after the morning dose on Day 1|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
1422964|NCT01073943|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.|||participants|||Number
1422949|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
1422950|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1422951|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
1422952|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
1422953|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-072|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-072 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-072 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1422954|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
1422955|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
1422965|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1425749|NCT01048606|Primary|Glucose Metabolism: 2h-75g Oral Glucose Tolerance Test (OGTT) + Plasma Insulin and Glucose Concentrations (Blood Sample Analysis).||Baseline|||||||
1422956|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of Ritonavir|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ritonavir using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ritonavir was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1422957|NCT01074008|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng*hr/mL||Standard Deviation|Mean
1422958|NCT01074008|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||Hours||Standard Deviation|Mean
1422959|NCT01074008|Primary|Maximum Plasma Concentration (Cmax) of ABT-450|Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-450 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-450 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Immediately prior to morning dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)|All participants who received at least one dose of study drug (direct-acting antiviral agent) were included in the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1422960|NCT01074008|Secondary|Percentage of Participants With Partial Early Virologic Response (EVR) at Week 12|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. Partial early virologic response (EVR) was defined as HCV RNA levels that decreased > 2 log10 IU/mL at Week 12 as compared to baseline. The baseline value was the last measurement before the first dose on Day 1. Data are reported as the percentage of participants with partial EVR.|Baseline and Week 12|To be included in the efficacy analysis, participants received at least one dose of study drug (direct-acting antiviral agent) and at least one post-baseline measurement of HCV RNA levels.|||percentage of participants|||Number
1422961|NCT01074008|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification (LLOQ) of 25 IU/mL. Rapid virologic response was defined as HCV RNA level < LLOQ (< 25 IU/mL) at Week 4. Data are reported as the percentage of participants with RVR.|Week 4|All participants who received at least one dose of study drug and had at least one post-baseline HCV RNA value were included in this efficacy analysis.|||percentage of participants|||Number
1422962|NCT01074008|Primary|Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-450/r, ABT-333, or ABT-072 Monotherapy Treatment|Plasma HCV RNA levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay that had a lower limit of detection of 10 IU/mL and a lower limit of quantification of 25 IU/mL. The baseline value was the HCV RNA level before the first dose of study drug on Day 1. The maximal change during monotherapy was the difference from baseline to the lowest log10 HCV RNA level anytime after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 4. Data are reported as the mean ± standard deviation.|Prior to dosing on Day 1 to before the morning dose on Day 4|Participants received at least one dose of study drug (direct-acting antiviral agent) and have both baseline and at least one post-baseline measurement of HCV RNA levels during monotherapy treatment.|||log10 IU/mL||Standard Deviation|Mean
1422963|NCT01073943|Other Pre-specified|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. See Outcome #2 for definitions of the scale. Assessment of mid colon, recto-sigmoid, and overall (ascending, mid, and recto-sigmoid) cleansing is summarized here.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
1425750|NCT01048606|Primary|Plasma Lipid Profile: the Apolipoproteins (Apo-AI, Apo-AII, Apo-B), Cholesterol HDL, LDL and Triglycerides Levels Will be Determined by Clinical Analyses of Blood Sample (Obtained After 12 h Fasting State)||Baseline|||||||
1422968|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422969|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422970|NCT01073943|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422971|NCT01073943|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Cleansing of the ascending colon was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
1422972|NCT01073943|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
1422973|NCT01073930|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.|up to one month|Safety population of participants who were treated.|||participants|||Number
1422974|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422975|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422976|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. One participant either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422977|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422978|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Two participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1423131|NCT01072344|Secondary|Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition.|Discontinuation emergent signs and symptoms checklist (DESS) is a patient-rated measure of the presence and severity of discontinuation symptoms occurring after medication discontinuation. %|26 weeks|These are responders at the end of Phase II of the study and then were randomized in Phase III of the study|||Participants|||Count of Participants
1422979|NCT01073930|Secondary|Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?|Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question.|||percentage of participants|||Number
1422980|NCT01073930|Secondary|Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
1422981|NCT01073930|Primary|Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist|Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.|Day 2|Intent-to-treat population of randomized and treated participants with efficacy assessments performed.|||percentage of participants|||Number
1422982|NCT01073865|Secondary|Oestradiol (E2) Serum Concentrations at 24 Weeks|E2 serum concentrations (pg/mL) at 24 weeks|24 weeks after the first dosing|Full Analysis Set|||pg/mL||Standard Deviation|Mean
1422983|NCT01073865|Secondary|Number of Responders at 24 Weeks|Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.|24 weeks after the first dosing|Full Analysis Set|||Patients|||Number
1422984|NCT01073865|Primary|Number of Patients With Progression-free Survival (PFS) at 24 Weeks|A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.|24 weeks after the first dosing|Full Analysis Set|||Participants|||Number
1422985|NCT01073657|Primary|"Supported Education Process Measure"|"Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the Supported Education Process Measure (Corrigan, 2009)."|6 months|Comparison of means|||number of quarter hours||Standard Deviation|Mean
1422986|NCT01073631|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.|Baseline (Day 1) up to 2.1 Years|ITT; N=number of participants evaluated for mycological response.|||Percentage of participants|||Number
1422987|NCT01073631|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2.1 Years|Safety population: participants received at least 1 dose of study drug for approved indication (= Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related paramenters at least once.|||Percentage of participants|||Number
1422988|NCT01073618|Secondary|Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable|In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study medication; Not evaluable=a follow-up mycological cultivation is not performed.|Baseline (Day 1) up to 2 years|ITT; N=number of subjects evaluated for mycological response.|||percentage of participants|||Number
1422989|NCT01073618|Primary|Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable|Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).|Baseline (Day 1) up to 2 years|Safety population: participants received at least 1 dose of study drug for the approved indication (=Intent to treat [ITT] population plus all unevaluable participants); ITT=participants received study drug for the approved indication and had been evaluated for related parameters at least once.|||percentage of participants|||Number
1423132|NCT01072344|Secondary|Frequency, Severity, and Duration of Treatment-emergent Adverse Events.|We will report the frequency, severity, and duration of treatment-emergent adverse events by treatment arm.|26 weeks|During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.|||Participants|||Count of Participants
1422990|NCT01073605|Secondary|Number of Subjects Reaching Puberty|The defined criteria for reaching puberty were: boy=if right or left testes volume ≥4 ml; girl=if breast development ≥2. Tanner Adolescent Pubertal Staging Questionnaire documents the stage of development of secondary sexual characteristics rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Onset of puberty was defined as the visit where the data recorded first met the above criteria for starting puberty.|Baseline, 1 to 6 years|Safety population. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years. Started = started puberty; Not Started = not started puberty yet as per Tanner scale.|||participants|||Number
1422991|NCT01073605|Secondary|Chronological Age at Onset of Puberty|Chronological age (years) at first study visit with onset of puberty = (Date of study visit minus Date of Birth) divided by 365.25.|Onset of puberty|Safety population. Number of participants analyzed = number of subjects who started puberty by the end of the study.|||Years||Standard Deviation|Mean
1422992|NCT01073605|Secondary|Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio|Bone age was determined by the Greulich-Pyle method. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. Chronological Age used was the age at the date that the corresponding Bone Age X-ray was performed. Ratio was calculated by change from Baseline in bone age divided by change from Baseline in chronological age.|1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.|||ratio||Standard Deviation|Mean
1422993|NCT01073605|Secondary|Change From Baseline in Bone Age|Bone age was determined by the Greulich-Pyle method. Calculated by substracting bone age at Baseline from bone age at each year|Baseline, 1 to 3 years|Safety population = all subjects who received at least 1 study dose of GH. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point.|||Years||Standard Deviation|Mean
1422994|NCT01073605|Secondary|Weight||Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||kg||Standard Deviation|Mean
1422995|NCT01073605|Secondary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||kg/m^2||Standard Deviation|Mean
1422996|NCT01073605|Secondary|Change From Baseline in Height (SDS)|Calculated by substracting height SDS at Baseline from height SDS at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||SDS||Standard Deviation|Mean
1422997|NCT01073605|Secondary|Height (SDS)|Calculated using Sempe reference means and standard deviations for height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||SDS||Standard Deviation|Mean
1422998|NCT01073605|Secondary|Change From Baseline in Height (cm)|Calculated by substracting height at Baseline from height at each year. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at Baseline and each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||cm||Standard Deviation|Mean
1422999|NCT01073605|Secondary|Height (cm)|Performed by use of a wallmounted device (eg, Harpenden Stadiometer). Each subject was measured 3 times and the mean of these measurements was recorded as the present height. Final Height: Children are defined as reaching their final height when annual Growth Rate is less than 2 cm in the previous year and bone age is equal to or greater than 17 years in boys and equal to or greater than 15 years in girls.|Baseline, 1 to 6 years, final height|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||cm||Standard Deviation|Mean
1423000|NCT01073605|Secondary|Change From Baseline in Annual Growth Rate SDS|Calculated corresponding to the gender and chronological age by substracting annual growth rate SDS at Baseline from annual growth rate SDS at each year.|Baseline, 1 to 3 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at 1 year. n = number of subjects with evaluable data at each time point.|||SDS||Standard Deviation|Mean
1423001|NCT01073605|Secondary|Annual Growth Rate Standard Deviation Score (SDS)|Calculated using Sempe reference means and standard deviations for growth rate according to age and sex. Standardization was performed for chronological age.|Baseline, 1 to 6 years|FAS. Number of Participants Analyzed = number of subjects with evaluable data at Baseline. n = number of subjects with evaluable data at each time point. Data beyond 6 years are not reported due to the low proportion of subjects followed up beyond 6 years.|||SDS||Standard Deviation|Mean
1423133|NCT01072344|Secondary|The Proportion of Subjects in Each Treatment Condition Who Relapse.|The proportion of subjects in each treatment condition who relapsed after randomization|26 weeks|During phase II consolidation phase, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo.|||Participants|||Count of Participants
1423002|NCT01073605|Primary|Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm|Annual growth rate was expressed as height velocity (centimeter [cm]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx – Height Y{x-1}) / {(Date of Yx – Date of Y{x-1}) /365.25}|Baseline, 2 years|All subjects who received at least 1 study dose of Genotonorm were included in the Full Analysis Set (FAS). Number of Participants Analyzed = number of subjects with change in annual growth rate at 2 years.|||cm/year||Standard Deviation|Mean
1423003|NCT01073566|Secondary|Self-reported Hypoglycemic Episodes|Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be <50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.|6 weeks|Intent to treat|||episodes|||Number
1423004|NCT01073566|Secondary|Insulin Delivery System Rating|Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.|6 weeks|Per Protocol|||units on a scale||Standard Deviation|Mean
1423005|NCT01073566|Secondary|Glucose Profiles Per Day|Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days|6 weeks|Intent to Treat|||mmol/L||Standard Error|Least Squares Mean
1423006|NCT01073566|Primary|Mean Daily Blood Glucose|Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose|6 weeks|Intent to treat|||mmol/L||Standard Error|Least Squares Mean
1423007|NCT01073462|Secondary|Number of Participants With Cardiac Disease Progression|Cardiac disease progression was determined by the Investigator.|Month 3, 6, 12, 18, and 24|Intent-to-treat|||participants|||Number
1423008|NCT01073462|Secondary|Percentage of Participants Experiencing Hospitalization|The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.|24 months|Intent-to-treat|||percentage of participants|||Number
1423009|NCT01073462|Secondary|Percentage of Participants With at Least One Concomitant Medication|"The percentage of participants with at least one concomitant medication during the course of the study, by the following types:~Phosphate binder~Epoetin~Renin-Angiotensin-Aldosterone System (RAAS) inhibitors~Cinacalcet~Other"|24 months|Intent-to-treat|||percentage of participants|||Number
1423010|NCT01073462|Secondary|Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.|Baseline to Month 24|Intent-to-treat|||percentage of participants|||Number
1423011|NCT01073462|Secondary|Percentage of Participants With at Least a 30%-Reduction in iPTH Levels|The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used.|||percentage of participants|||Number
1423012|NCT01073462|Secondary|Percentage of Participants With Hyperphosphatemia|Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|"Intent-to-treat; LOCF was used. n indicates the number of participants with available data at each time point."|||percentage of participants|||Number
1423013|NCT01073462|Secondary|Percentage of Participants With Hypercalcemia|Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit.|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat; LOCF was used|||percentage of participants|||Number
1423014|NCT01073462|Primary|Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range|Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 – 31.8 pmol/L (150 to 300 pg/mL).|Baseline and Months 3, 6, 12, 18, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
1423015|NCT01073449|Secondary|Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|693 represents the number of patients implanted with an ICD within the whole population|||Participants||95% Confidence Interval|Number
1423016|NCT01073449|Primary|Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months||||Participants||95% Confidence Interval|Number
1423017|NCT01073449|Secondary|Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up||4 months|2246 represents the number of patients in the whole population that were implanted with a PM|||Participants||95% Confidence Interval|Number
1423018|NCT01073293|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
1423036|NCT01073163|Secondary|Number of Participants With Treatment-Emergent Cardiac Disorders|Number of participants with cardiac disorders overall, with severity from grades 1 (mild) to grade 4 (severe), according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Participants may have reported more than 1 event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
1423019|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants||95% Confidence Interval|Number
1423020|NCT01073293|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint|||ELU/mL||95% Confidence Interval|Geometric Mean
1423021|NCT01073293|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL.|4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants||95% Confidence Interval|Number
1423022|NCT01073293|Primary|Percentage of Participants With a Systemic Adverse Experience|For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.|Up to 15 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
1423023|NCT01073293|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
1423024|NCT01073293|Primary|Percentage of Participants With a Repevax™ Injection-site Adverse Experience|For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
1423025|NCT01073293|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
1423026|NCT01073293|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||milli Merck Units/mL||Full Range|Geometric Mean
1423027|NCT01073267|Primary|Objective Response Rate|"Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT).~Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score."|Baseline and at least 2 months|Intent to treat population.|||proportion of participants|||Number
1423028|NCT01073163|Secondary|Worst Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grades for Hematology Laboratory Tests Results Overall|Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Overall is defined as the worst postbaseline grade value for each patient and laboratory test across all cycles. Only postbaseline grades are summarized. If absolute neutrophil count (ANC) and neutrophils absolute (ABS) were both measured, the worse grade value from the two was summarized. Otherwise the worst ANC grade value or the worst neutrophils ABS grade value was summarized. WBC=white blood cell; LLN=lower limit of normal|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
1423029|NCT01073163|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at Endpoint|The investigator assessed each patient’s ECOG performance status according to the ECOG scale at screening, on Day 1 of each treatment cycle, and at the end-of-treatment visit. Scale scores were: 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2=ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=dead. Any change in score to a higher value signifies worsening, and any change to a lower value signifies improvement.|End of study. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
1423030|NCT01073163|Secondary|Overview of Adverse Events|Adverse event (AE)=any untoward medical occurrence in a patient administered study drug that develops or worsens in severity during the conduct of a clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. Treatment-related AEs=those that began or worsened after treatment with study drug. AE severity was graded according to the National Cancer Institute's Common Terminology Criteria for AEs (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5= death). Relationship of an AE to study drug was categorized as definite, probable, possible, unlikely, or not related. Serious AE (SAE)=one that occurred at any dose that resulted in any of the following outcomes or actions: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; or an otherwise important medical event.|Adverse events were collected throughout the study and up to 30 days after the last dose of study drug. The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Safety Analysis Set: enrolled participants who received 1 or more doses of study drug.|||participants|||Number
1423031|NCT01073163|Secondary|Percentage of Participants With Overall Response|Overall Response was comprised of those participants who had Complete Response (CR) plus those who had Partial Response (PR), as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.|||percentage of participants||95% Confidence Interval|Number
1423032|NCT01073163|Secondary|Percentage of Participants With Complete Response (CR)|Complete response, as defined by the International Working Group (IWG) Revised Response Criteria For Malignant Lymphoma. Results are presented for participants with non-Hodgkin lymphoma and mantle cell lymphoma as well as all participants.|The median number of 28-day cycles was 6.0. The median duration of the treatment period was 143 days.|Full Analysis Set: all enrolled participants who received at least 1 dose of both bendamustine and rituximab and who had both a baseline and at least 1 postbaseline tumor response evaluation.|||percentage of participants||95% Confidence Interval|Number
1423033|NCT01073163|Secondary|Rituximab Concentrations at 0.5 Hours, 24 Hours, and 7 Days Postinfusion||Day 1 of Cycle 1: prior to start of rituximab infusion, immediately postinfusion. Day 2 of Cycle 1: 15 minutes prior to the start of the bendamustine infusion. Day 7 and Day 14: anytime. Day 1 of Cycle 2: prior to start of rituximab infusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable serum concentration of rituximab.|||mcg/mL||Full Range|Median
1423034|NCT01073163|Secondary|Model-predicted Bayesian Bendamustine Clearance in the Presence of Rituximab|Boxplots of model-predicted Bayesian bendamustine clearance (CL) values in the presence of rituximab were generated based on the administered bendamustine doses, rate of infusion, and sample times.|Day 1 of Cycle 1: prior to start of bendamustine infusion, immediately postinfusion, 15 minutes and 30 minutes postinfusion. Day 2 of Cycle 1: 15 minutes prior to start of bendamustine infusion, 15 minutes, 30 minutes, 1, 3, and 5 hours postinfusion.|Pharmacokinetic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 quantifiable bendamustine plasma concentration.|||L/h||Full Range|Median
1423035|NCT01073163|Secondary|Change From Baseline in QTcF at Maximum Concentration (Cmax) of Bendamustine and Its Metabolites (M3 and M4)|Results from a pharmacokinetic-pharmacodynamic model to show the relationship of the overall predicted change from Baseline in QTcF at the average Cmax of bendamustine and its metabolites M3 and M4.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|Pharmacokinetic-pharmacodynamic Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG and at least 1 ECG with a time-matched plasma concentration pair.|||ms||95% Confidence Interval|Mean
1423125|NCT01072396|Secondary|Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime|Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
1423037|NCT01073163|Secondary|Number of Participants With New Onset ECG Waveform Morphological Changes|The core ECG laboratory cardiologist assessed all leads in the ECGs and defined morphological changes. Changes from baseline (looking at each of the 3 ECGs at Day 2 Cycle 1 individually and the ECGs at all on-treatment time points individually) were noted for the following events: atrial fibrillation or flutter; second degree heart block; third degree heart block; complete right bundle branch block; complete left bundle branch block; ST segment depression; T wave abnormalities (negative T waves only); myocardial infarction pattern; any new abnormal U waves.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.|||participants|||Number
1423038|NCT01073163|Secondary|Number of Participants With QTcF New Outlier Events at End of Infusion and 1 Hour Postinfusion|Participants were considered to have an outlier ECG value based on the most extreme value across each of the time points. “New” means not present at baseline and becomes present on at least 1 on-treatment ECG time point. A participant had a new outlier event (500) if the maximum QTcF was >500 ms while their baseline was <=500 ms, or had an outlier event (480) if the maximum QTcF was >480 ms while their baseline was <= 480 ms. QTcF in the 30-60 ms or >60 ms categories were also considered outliers.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion and 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.|||participants|||Number
1423039|NCT01073163|Secondary|Mean Change From Baseline in QTcF at 1 Hour Postinfusion|On Day 2 of Cycle 1, three ECGs were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine 1 hour postinfusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): 1 hour postinfusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG.|||ms||Standard Deviation|Mean
1423040|NCT01073163|Primary|Mean Change From Baseline in QT Interval as Corrected by the Fridericia Method (QTcF) at End of Infusion|On Day 2 of Cycle 1, three electrocardiograms (ECGs) were collected 15 minutes prior to any study drug administration. The baseline ECG interval value was obtained by averaging these 3 ECGs, and was compared to the average of the 3 ECGs taken on treatment with bendamustine at the end of the infusion.|Baseline ECGs (Day 2 of Cycle 1): 15 minutes prior to bendamustine infusion. Postinfusion ECGs (Day 2 of Cycle 1): at the end of the 30-minute infusion.|ECG Analysis Set: all enrolled participants in study who received at least 1 dose of study drug and with at least 1 available baseline and 1 on-treatment ECG; n=number of participants with measurement at given time point.|||milliseconds (ms)||Standard Deviation|Mean
1423041|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423042|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423043|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423126|NCT01072396|Secondary|Constant Work Rate (CWR) Endurance Time|CWR exercise duration calculated as the length of time of the exercise period|six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.|||seconds||Standard Error|Least Squares Mean
1423044|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423045|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423046|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423047|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423048|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423049|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423050|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423158|NCT01072175|Secondary|Overall Survival (OS) in Part C|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. When calculating overall survival, deaths following crossover were included.|From the date of randomization until date of death due to any cause (up to approximately 17 months)|ITT Population|||Months||95% Confidence Interval|Median
1423051|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423052|NCT01072929|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423053|NCT01072929|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant’s insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1423054|NCT01072929|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1423055|NCT01072929|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1423056|NCT01072929|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug.|||participants|||Number
1423057|NCT01072929|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423203|NCT01072136|Secondary|Examine Adverse Events in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The proportion of participants experiencing one or more adverse events after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.|||percentage of participants|||Number
1423058|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423059|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit are those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423060|NCT01072929|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423061|NCT01072929|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
1423062|NCT01072929|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
1423063|NCT01072929|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1423064|NCT01072877|Secondary|Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance|The Independent Photography Review – Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient’s visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins).|8 weeks post treatment|Population consists of all patients who had a baseline and on-treatment assessment.|||units on a scale||Standard Error|Mean
1423065|NCT01072877|Secondary|Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)|The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from “Not at all noticeable” (a score of 0) to “Extremely noticeable” (a score of 4).|8 weeks||||units on a scale||Standard Error|Mean
1423066|NCT01072877|Primary|Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)|"The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient’s level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching).~The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity).~At Visit 2/baseline, Week 8, scores were calculated"|Week 8||||units on a scale||Standard Error|Mean
1423067|NCT01072773|Secondary|Duration of Response|Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.|Duration of Study (up to 5 years)|Neither participant achieved a response. Therefore, no duration of response calculation was performed.||||||
1423068|NCT01072773|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death|Duration of Study (up to 5 years)||||Months||95% Confidence Interval|Median
1423069|NCT01072773|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause.|Duration of Study (up to 5 years)||||Months||95% Confidence Interval|Median
1423070|NCT01072773|Secondary|Number of Participants With an Organ Response.|The number of patients that acheived a response in an affected organ.|Duration on treatment (up to 12 cycles/months)||||participants|||Number
1423071|NCT01072773|Secondary|Number of Participants With Treatment Related Adverse Events.|"Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.~Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE~Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0."|Duration on treatment (up to 12 cycles/months)||||participants|||Number
1423072|NCT01072773|Primary|Number of Participants With a Confirmed Hematologic Response|"Response that was confirmed on 2 consecutive evaluations during treatment.~Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.~Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels."|Duration of treatment (up to 12 cycles/months)||||participants|||Number
1423073|NCT01072669|Primary|Digital Micro-vascular Flow|Change in digital micro-vascular flow measured by LDPI in patients with Raynaud’s phenomenon (RP) and digital ischemia secondary to SSc at 1 week and 12 weeks|Baseline and 12 weeks|Assuming a standard deviation of 0.40, and use of a two-sample t-test with significance level of 0.05, there will be 80% power to detect differences in the change from baseline of at least 0.65 units if moderate correlation (r=0.50) exists, and 0.45 units if strong correlation (r=0.75) exists between treated|||perfusion unit||95% Confidence Interval|Mean
1423074|NCT01072656|Secondary|Number of Patient Who Had >50% Reduction in VAS.|Patients report reduction in the VAS (Visual Analogue Scale Ranging from 0-10, 0 meaning no pain and 10 meaning worst pain imaginable) at the end of the open label phase (24 months post randomization f/u) compared to the pre-implantation baseline.|Baseline and 24 months||||Participants|||Count of Participants
1423075|NCT01072656|Secondary|Number of Participants Who Would Undergo the Procedure Again.|A positive answer from patients receiving active stimulation at the end of the open label phase of the study to the question: ‘would you undergo this procedure again if you were to get the same benefits you experienced?’|End of Open Label Phase (24 months)||||Participants|||Count of Participants
1423076|NCT01072656|Secondary|Number of Participants Who Had 50% Improvement in PDI|A 50% improvement in pain related disability (as assessed by the pain disability index) at the end of the open label phase compared to the pre-implantation baseline. The PDI ranges from 0-10 with 0 equaling no disability and 10 equaling worst disability.|24 months post randomization follow up||||Participants|||Count of Participants
1423077|NCT01072656|Primary|Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)|Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, & Self-care. This is an average score of the 3 month period for each Active and Sham phase.|Blinded stimulation phase (3 Months)||||participants|||Number
1423078|NCT01072643|Secondary|To Demonstrate That DEX is a Safe Sedative in Pediatric Subjects With PHTN||24 hours|||||||
1423079|NCT01072643|Secondary|To Obtain Pharmacokinetic Data in This Population||6 hours|||||||
1423080|NCT01072643|Secondary|To Quantify the Effect of DEX on PVR in Pediatric Subjects With Pulmonary Hypertension and Its Dependence on Baseline PVR||Every individual patient will be studied over maximum of 4 hours during the dose escalation phase. This part of the study will be completed in 1 year|||||||
1423081|NCT01072643|Secondary|Efficacy of Sedation With DEX||Subjects will participate in a dose escalation study which will define minimal effective dose that results in effective sedation in ≥ 7 out of 8 patients in that dose cohort. Maximum upto 4 hours|||||||
1423082|NCT01072643|Primary|The Primary Endpoint Will be the Change in PVR in Wood Units|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization;|For each subject PVR will be measured by cardiac catheterization at T0 ( baseline measurement) , after DEX bolus (T1) which is given over 10 minutes and after 30 mins after start of the DEX infusion (T2) - Maximum upto 4 hours||||wood units|||Number
1423083|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423084|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423085|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. This question is asked if the answer to the 'Non-Specific Active Suicidal Thoughts' question was YES, or based on the judgment of the assessor. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423086|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423087|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423088|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423089|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423090|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423091|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423092|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423093|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question|"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit."|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423094|NCT01072630|Secondary|Columbia-Suicide Severity Rating Scale ‘Since Last Visit’ Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question|The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.|Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with treatment assessments at the indicated time period.|||participants|||Number
1423095|NCT01072630|Secondary|Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score|The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1423096|NCT01072630|Secondary|Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score|HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug. The number analyzed includes participants with both baseline and during treatment assessments.|||units on a scale||Standard Deviation|Mean
1423127|NCT01072396|Primary|Change From Baseline in Inspiratory Capacity (IC) at Isotime|Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.|baseline, six weeks of treatment|Full Analysis Set (FAS) includes all patients with at least one baseline (at Visit 3 or 5) and two non-missing post-dosing data (at Visits 4 and 6) for the primary endpoint.|||liter||Standard Error|Least Squares Mean
1423097|NCT01072630|Secondary|Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score|The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.|Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)|The safety analysis set includes randomized participants who took 1 or more doses of study drug.|||units on a scale||Standard Deviation|Mean
1423098|NCT01072630|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis."|Day 1 to Week 9|The safety analysis set includes randomized participants who took 1 or more doses of study drug|||participants|||Number
1423099|NCT01072630|Secondary|Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423100|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression|The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423101|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)|The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The number of participants at each visit is those with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423102|NCT01072630|Secondary|Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. Participants are included in the analysis at each timepoint if they have a nonmissing value at that visit. Endpoint for analyses was the last observed postbaseline data.|||units on a scale||Standard Deviation|Mean
1423103|NCT01072630|Secondary|Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
1423128|NCT01072357|Secondary|Endothelial Cell Density|Endothelial Cell Density (Assessed at Weeks 26 & 52). Measure of the number of cells present within the endothelium that are responsible for providing the cornea with nourishment.|52 Weeks||||Number of cells per millimeters squared||Standard Deviation|Mean
1423104|NCT01072630|Secondary|Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression."|Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment. The denominator for calculating the percentages at each visit is the number of participants with a nonmissing value at that visit. Endpoint was the last observed postbaseline data.|||percentage of participants|||Number
1423105|NCT01072630|Primary|Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)|"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression."|Day 0 (baseline), Week 8|Full analysis set which includes participants who took 1 or more doses of study drug and who have at least 1 postbaseline IDS-C30 efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1423106|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - General Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment||||percentage of change||Standard Deviation|Mean
1423107|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - Negative Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment||||percentage of change||Standard Deviation|Mean
1423108|NCT01072617|Secondary|Positive and Negative Syndrome Scale (PANSS) - Positive Subscale|Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology.|Baseline, 5 days (post-treatment), 1 week post treatment||||percentage of change||Standard Deviation|Mean
1423109|NCT01072617|Primary|Adverse Events|Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit.|3 weeks||||event|||Number
1423110|NCT01072539|Secondary|Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)|Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.|At the TOC or EOT assessment|Effectiveness Analysis Set from the prospective study phase; n refers to the total munber of participants who had evaluable data.|||Percentage of Participants|||Number
1423111|NCT01072539|Primary|Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics|Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.|From the time of the participant’s first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Analysis Set.|||Percentage of Participants||95% Confidence Interval|Number
1423112|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site|Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as “effective” to the treatment of Tygacil .|At the TOC or EOT assessment|Effectiveness Analysis Set.|||Percentage of Participants||95% Confidence Interval|Number
1423113|NCT01072539|Secondary|Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment|Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as “effective” to the treatment of Tygacil .|At the TOC or EOT assessment|Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least.|||Percentage of Participants||95% Confidence Interval|Number
1423114|NCT01072539|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs|All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as “unlikely”, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.|From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.|Safety Anaysis Set|||Percentage of Participants|||Number
1423115|NCT01072526|Other Pre-specified|Change in Severity of Ocular Discomfort|This will be calculated using a composite score of the primary and secondary outcome measures.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
1423116|NCT01072526|Secondary|Change in Schirmer Tear Test With Anesthesia Result|Assesses how quickly tears are produced, measured in millimeters (mm) on blotting paper. Greater than 15 mm indicates normal tear production; lower measurement indicates presence of dry eye disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
1423117|NCT01072526|Secondary|Change in Fluorescein Staining Scale|Demonstrates abrasions on cornea and extent of disease. Graded on a scale of 0-5 with 5 being the worst score.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
1423118|NCT01072526|Secondary|Change in Tear Film Breakup Time|Interval between last blink and break-up of tear film, measured in seconds. Less than 10 seconds = dry eye disease; lower score indicates worse disease.|Baseline, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
1423119|NCT01072526|Primary|Change in Ocular Surface Disease Index (OSDI)|Measures dry eye disease and effect on vision-related function. Measured on a scale of 0-100, with higher scores indicating greater disability.|Start of treatment, 6 weeks|Any data collected was not analyzed because the study was terminated after the PI left the institution. No data is available for reporting as all study personnel have left the institution.||||||
1423120|NCT01072500|Secondary|Persistent Mobility Disability (Assessed Every 6 Months)|The assessment of major mobility disability (the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When MMD could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 m walk within 15 minutes.) at two consecutive time points or MMD followed by death.|Median 2.7 years/Average 2.6 years||||participants|||Number
1423121|NCT01072500|Primary|Major Mobility Disability, Defined as Incapacity to Walk 400 Meters|The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant’s home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record–reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes.|Median 2.7 years/Average 2.6 years||||participants|||Number
1423122|NCT01072448|Secondary|Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)|An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|End of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1423123|NCT01072448|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1423124|NCT01072409|Primary|CNC Monosyllabic Word Performance - Treated Ear|CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.|12 months||||percent correct||Standard Error|Mean
1425751|NCT01048606|Primary|Body Composition: Dual-energy X-ray Absorptiometry Method||Baseline||||percent of total fat mass||Standard Deviation|Mean
1423134|NCT01072344|Primary|Time to Relapse in Each Treatment Condition.|The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Relapse is dichotomously defined as an increase in CGI/S (a clinician-rated global measure of anxiety's severity) score from ≤ 3 (at study visit 6) to ≥ 4 (on two consecutive scheduled or unscheduled study visits ≥ 2 weeks apart) plus meeting DSM IV-TR criteria for GAD (minus the 6-month time criterion).|26 weeks|All 93 subjects started randomization phase of the study were included in the analysis|||weeks||Standard Deviation|Mean
1423135|NCT01072331|Primary|Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 to 2h (Breakfast, Lunch and Dinner)||4 weeks||||mg・h / dL||Standard Error|Least Squares Mean
1423136|NCT01072331|Secondary|Change From Baseline in Fasting Plasma Glucose||4 weeks||||mg / dL||Standard Error|Least Squares Mean
1423137|NCT01072331|Secondary|Change From Baseline in 24-h Mean Glucose||4 weeks||||mg / dL||Standard Error|Least Squares Mean
1423138|NCT01072331|Primary|Change From Baseline in 2-h Postprandial Glucose (Breakfast, Lunch and Dinner)||4 weeks||||mg / dL||Standard Error|Least Squares Mean
1423139|NCT01072201|Primary|Mean Percentage of Plaque Scores|Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.|6 Months||||percentage of dental plaque||Standard Deviation|Mean
1423140|NCT01072201|Primary|Mean Pocket Depth|Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.|6 Months||||Millimeters||Standard Deviation|Mean
1423141|NCT01072201|Primary|Bleeding on Probing|Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.|6 months||||Percentage of bleeding sites||Standard Deviation|Mean
1423142|NCT01072188|Primary|Air Blast|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|Immediately after product application||||Units on a scale||Standard Deviation|Mean
1423143|NCT01072188|Primary|Hypersensitivity to Touch (Tactile)|Units on a scale: Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. The higher the score, the higher the hypersensitivity.|Immediately after product application||||Units on a scale||Standard Deviation|Mean
1423144|NCT01072175|Secondary|Overall Survival in Part D|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact. Validation of OS is currently ongoing; thus, data are not available at this time.|From the date of first dose until date of death due to any cause (up to approximately 14 months)||2019-04-30|04/2019||||
1423145|NCT01072175|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator in Part D|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 13 months)|ITT Population|||Months||95% Confidence Interval|Median
1423146|NCT01072175|Secondary|Duration of Response as Assessed by the Investigator in Part D|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 13 months)|ITT Population. Only those participants who had CR or PR were considered.|||Months||95% Confidence Interval|Median
1423147|NCT01072175|Secondary|Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants in Part D|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter [mm] in the short axis.) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). To be assigned a status of PR or CR, a confirmatory disease assessment should be performed no less than 28 days after the criteria for response are first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the date of first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 280 days )|ITT Population|||Participants|||Number
1423204|NCT01072136|Secondary|Determine Pelvic Inflammatory Disease (PID) in Patients Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC) in Comparison to no Treatment.|The number of participants experiencing PID after randomization.|At 2-3 week and 2 month (Day 50-70) follow-up.|Participants who were randomized and received study product.|||participants|||Number
1425752|NCT01048593|Primary|Number of Participants With Clearing of Anterior Chamber Cells (ACC=0)||Day 8||||participants|||Number
1425753|NCT01048593|Primary|Anterior Chamber Cells = 0 at Day 8 Post Treatment||Day 8 post treatment|||||||
1423148|NCT01072175|Secondary|Area Under the Concentration-time Curve Assessment of Trametinib in Part D|AUC(0-tau) after single and repeat dose of trametinib alone and in combination with dabrafenib was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, AUC(0-tau) was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng*h/mL||95% Confidence Interval|Geometric Mean
1423149|NCT01072175|Secondary|The Tmax Assessment of Trametinib in Part D|The tmax of trametinib after single and repeat dose in combination with dabrafenib (DAB) was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, tmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||Hours||Full Range|Median
1423150|NCT01072175|Secondary|The Cmax Assessment of Trametinib in Part D|Cmax of trametinib after single and repeat dose in combination with DAB was observed at Day 1 and Day 21. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.Participants receiving DAB 75 mg to DAB 75 mg + Trametinib 2 mg and those receiving DAB 150 mg to DAB 150 mg + Trametinib 2 mg did not receive Trametinib until Day 29; therefore, Cmax was not analyzed in these participants at Days 1 and 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
1423151|NCT01072175|Secondary|Area Under the Concentration-time Curve (AUC) of Dabrafenib Metabolites in Part D|Area under the concentration-time curve (AUC) from pre-dose to dosing interval (AUC[0-tau]), from pre-dose to the last time of quantifiable concentration (AUC[0-tau]), and from pre-dose extrapolated to infinity (AUC[0-inf]) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1423152|NCT01072175|Secondary|The Tmax of Dabrafenib Metabolites in Part D|The time to Cmax (tmax) of DAB metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||Hours||Full Range|Median
1423153|NCT01072175|Secondary|Cmax of Dabrafenib Metabolites in Part D|The maximum concentration (Cmax) of dabrafenib metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) after single and repeat doses of DAB alone and in combination with trametinib was measured at Day 1 and Day 21.|Day 1: pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose. Day 21: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dose|PK Population. Only participants who were available at the indicated timepoints were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
1423154|NCT01072175|Secondary|Oral Volume of Distribution (V/F) of Dabrafenib and Trametinib|Oral volume of distribution (V/F) of dabrafenib and trametinib were assessed using a population approach. Oral volume of distribution (V/F) is defined as the apparent volume of distribution in the central compartment.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population|||Liters (L)||95% Confidence Interval|Mean
1423155|NCT01072175|Secondary|Oral Clearance (CL/F) of Dabrafenib and Trametinib|Oral clearance (CL/F) of dabrafenib and trametinib were assessed using a population approach. Oral clearance (CL/F) is defined as the apparent volume of plasma in the vascular compartment cleared of drug per unit time by the processes of metabolism and excretion. For dabrafenib, population CL/F is defined as inducible and non-inducible CL/F. As dabrafenib induces its own metabolism, total oral clearance at steady state includes a non-induced (Day 1) component and an induced component, as estimated by a population PK model.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, and Week 48|PK Population|||Liters per hour (L/hr)||95% Confidence Interval|Mean
1423156|NCT01072175|Secondary|Plasma Concentrations of Trametinib in Part C|Plasma concentrations of trametinib was assessed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng/mL||Full Range|Median
1423157|NCT01072175|Secondary|Plasma Concentrations of Dabrafenib and Its Metabolites in Part C|Plasma concentrations of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were assesed following daily dose of dabrafenib and trametinib.|Day 15, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, and Week 56|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng/mL||Full Range|Median
1423632|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18)|Week 26|Full Analysis Set (FAS) includes all randomised subjects. For 29 subjects, values were missing.|||Subjects|||Number
1423159|NCT01072175|Secondary|Pre- and Post-dose H-scores for Individual Participants in Part B|p-ERK and p-AKT, biomarkers in tumor biopsies, were assessed for participants with BRAF mutant colorectal cancer. The H-score, which is a composite score that comprises intensity and percentage of staining, is a method of assessing the amount of protein or phospho-protein present in a biopsy sample. The score is obtained by the formula: (3 * percentage of strongly staining nuclei) + (2 * percentage of moderately staining nuclei) + (percentage of weakly staining nuclei). The H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Screening and at disease progression (up to approximately 8 months)|Biomarker Population: participants with H-score data for pre- and post-biopsy pairs|||scores on a scale|||Number
1423160|NCT01072175|Secondary|Overall Survival (OS) in Part B BRAFi Naïve Melanoma Participants|OS is defined as the interval of time between the date of randomization until the date of death due to any cause. For the participants who did not die, overall survival was censored at the date of last contact.|From the date of first dose until date of death due to any cause (up to approximately 22 months)|All Treated Population.|||Months||95% Confidence Interval|Median
1423161|NCT01072175|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma in Part B|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve were the participants with BRAF-mutation positive melanoma who had not received prior therapy with a BRAF-inhibitor..|From the date of first dose to the earliest date of disease progression (PD) or death due to any cause (up to approximately 22 months)|All Treated Population.|||Months||95% Confidence Interval|Median
1423162|NCT01072175|Secondary|Duration of Response as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma in Part B|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 22 months)|All Treated Population. Only those participants who had a CR or PR were analyzed.|||Months||95% Confidence Interval|Median
1423163|NCT01072175|Secondary|Number of Participants With BRAFi-naïve Mutant Metastatic Melanoma With the Best Overall Response as Assessed by Investigator in Part B|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter [mm] in the short axis.) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to 103 weeks)|All Treated Population|||Participants|||Number
1423164|NCT01072175|Secondary|The Tmax Assessment of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|The tmax is defined as the time of occurrence of Cmax. The PK parameter for tmax was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.|||Hours||Full Range|Median
1423165|NCT01072175|Secondary|The Ctau and Cmax Assessments of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose or Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
1423166|NCT01072175|Secondary|The AUC (0-tau) Assessment of Trametinib in Combination With Dabrafenib in Part B (Analyte=GSK1120212)|AUC (0-tau) is defined as area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration. AUC (0-tau) was assessed for plasma trametinib following repeat dosing of trametinib in combination with dabrafenib. Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1423206|NCT01072032|Secondary|EEG Spectral Coherence Estimates|EEG coherence reflects the degree to which brain regions communicate. It is derived from calculating the degree of association between regions in specified frequency bandwidths; it is like a correlation, except that the values range from 0-1 instead of -1 to 1, so technically there are no units as it is a coefficient. Higher coherence values indicate stronger associations between regions.|3 weeks||||Coherence ratio||Standard Deviation|Mean
1423167|NCT01072175|Secondary|The Tmax of Dabrafenib and Its Metabolite in Combination With Trametinib in Part B|The tmax is defined as the time of occurence of Cmax. Tha tmax was assessed for plasma dabrafenib (DAB) following repeat dosing of dabrafenib 75 and 150 mg BID administered in combination with trametinib. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.|||Hours||Full Range|Median
1423168|NCT01072175|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) and Maximum Plasma Concentration (Cmax) of Dabrafenib and Its Metabolite in Combination With Trametinib in Part B|Pre-dose (trough) concentration at the end of the dosing interval (Ctau) and maximum plasma concentration (Cmax) were assessed for plasma dabrafenib (DAB) following repeat dosing of DAB administered in combination with trametinib (T). The trough concentration is defined as the plasma level of a pharmaceutical product measured just before the next dose. Blood samples for PK analysis of the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) of dabrafenib were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time points were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
1423169|NCT01072175|Secondary|The AUC [0-tau] of Dabrafenib (DAB) and Its Metabolite in Combination With Trametinib (T) in Part B|Area under the concentration-time curve from time zero (predose) until the last time of quantifiable concentration (AUC [0-tau]) was assessed. Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at Day 15 pre-dose and Day 21 pre-dose and at 1, 2, 4, 6, and 8 hours post-dose administration.|Day 15 and Day 21|PK Population. Only those participants who were available at the indicated time point were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1423170|NCT01072175|Secondary|Steady State Concentration of Trametinib With Concomitant Administration of Dabrafenib in Part A|The steady state plasma concentration (Css) of trametinib with concomitant dabrafenib administration was assessed at Day 15 and Day 16. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated.|Day 15 and Day 16|PK Population|||ng/mL||Full Range|Median
1423171|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part D|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, millimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heartbeats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population|||Participants|||Number
1423172|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part D|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included lymphocytes, total neutrophils, hemoglobin, white blood cell count, platelet count, monocytes, mean corpuscle hemoglobin concentration, eosinophils, basophils, mean corpuscle hemoglobin, mean corpuscle volume, red blood cell count, hematocrit, erythrocyte sedimentation, reticulocytes. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population. Only those participants available at indicated timepoints were analyzed.|||Participants|||Number
1423173|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part D|Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Changes above (High) and below (Low) the normal range were evaluated for parameters not graded. Included:hyponatremia,gamma glutamyltransferase (GGT),aspartate aminotransferase (AST),hyperglycemia,alkaline phosphatase,hypokalemia,alanine aminotransferase (ALT),phosphorus inorganic,creatine kinase,total bilirubin,albumin,hyperkalemia, hypomagnesemia,lipase,hypokalemia,hyponatremia,urea/blood urea nitrogen (BUN),bicarbonate,creatine clearance,chloride,C-reactive protein,total protein,uric acid,troponin I,direct bilirubin,creatine kinase MB mass, chloride,total protein,bicarbonate,uric acid,creatine clearance,lactate dehydrogenase. Worst case change from BL was calculated as the post-BL value minus the BL value.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population. Only those participants available at indicated timepoints were analyzed.|||Participants|||Number
1423174|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part D|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event for possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximately 61 weeks)|ATP Population|||Participants|||Number
1423207|NCT01072032|Secondary|Functional Walking Measures|Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).|3 weeks||||cm/s||Standard Deviation|Mean
1423208|NCT01072032|Primary|Motor Control|Normalized jerk is a measure of movement smoothness, derived from jerk [(meters)/(second cubed)] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s^2)|3 weeks||||1/s^2||Standard Deviation|Mean
1423175|NCT01072175|Primary|AUC (0-tau) and AUC (0-inf) of Single and Repeat Doses of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|The PK parameters were determined for area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration AUC (0-tau) and from time zero (pre-dose) extrapolated to infinite time AUC (0-inf). Blood samples for PK analysis of the metabolites of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour only on Day 1) post-dose administration.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1423176|NCT01072175|Primary|The Tmax of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|tmax is defined as the time of occurence of Cmax. Blood samples for PK analysis of dabrafenib were obtained at Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin.|Day 1 and Day 21|PK Population. Only participants available at the indicated timepoints were analyzed.|||Hours||Full Range|Median
1423177|NCT01072175|Primary|Maximum Plasma Concentration (Cmax) of a Single and Repeat Dose of Dabrafenib Alone and in Combination With Trametinib in Part D (Analyte=GSK2118436)|The PK parameter Cmax was assessed. Blood samples for PK analysis of dabrafenib were obtained at pre-dose Day 1 and Day 21 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours (24 hour on Day 1 only) post-dose administration. From the plasma concentration-time curve, the PK parameter tmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 1 and Day 21|PK Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed|||ng/mL||95% Confidence Interval|Geometric Mean
1423178|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part C (Randomized)|Blood pressure were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred.lood pressure measurement included systolic blood pressure (BP, millimeter of mercury [mmHg]) and diastolic BP (DBP). Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value. Heart Rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population|||Participants|||Number
1423179|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part C (Randomized)|Hematology parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included: hemoglobin, lymphocytes, Total absolute neutrophil count (ANC), platelet count, white blood cells (WBC) count. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.|||Participants|||Number
1423180|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part C (Randomized)|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3 or Grade 4 occurred. For clinical chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Clinical chemistry parameters included: albumin, alkaline phosphate (ALKP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total Bilirubin, calcium, creatine kinase, creatinine, gamma glutamyltransferase (GGT), glucose, potassium, magnesium, sodium, inorganic phosphorus. Worst case change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.|||Participants|||Number
1423181|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part C (Randomized)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximately 75 weeks)|ATP Population|||Participants|||Number
1423182|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Investigator in Part C (Crossover)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants received anti-cancer therapy prior to the date of documented events, and censored at the last adequate assessment, prior to the initiation of therapy. If the participant did not have a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 9 months)|Crossover Population|||Months||95% Confidence Interval|Median
1425754|NCT01048541|Secondary|Median Absolute RU Volume||3 catheterisations on 1 day|||||||
1423183|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (BICR) in Part C (Randomized)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the BICR according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 17 months)|ITT Population|||Months||95% Confidence Interval|Median
1423184|NCT01072175|Primary|Progression-free Survival (PFS) as Assessed by the Investigator in Part C (Randomized)|PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment.|From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 17 months)|ITT Population|||Months||Full Range|Median
1423185|NCT01072175|Primary|Duration of Response as Assessed by the Investigator and Blinded Independent Central Review (BICR) in Part C (Randomized)|Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm.|First documented evidence of PR or CR until the date of the first documented sign of disease progression or the date of death due to any cause (up to approximately 17 months)|ITT Population. Only those participants who had a CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
1423186|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator in Part C (Crossover)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 15 weeks)|Crossover Population: participants who were randomized to and received at least one dose of dabrafenib monotherapy, and who elected to crossover to combination therapy following disease progression while on monotherapy|||Participants|||Number
1423187|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response Assessed by Blinded Independent Central Review (BICR) in Part C (Randomized)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis.) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by BICR as per RECIST, version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 36 weeks)|ITT Population|||Participants|||Number
1423188|NCT01072175|Primary|Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator in Part C (Randomized)|Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters [mm] in the short axis.) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.|From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 47 weeks)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered|||Participants|||Number
1423258|NCT01071200|Secondary|Percentage of Participants With Implantation|Implantation is the attachment and subsequent penetration by the zona-free blastocyst (usually in the endometrium) that starts five to seven days after fertilization.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||percentage of participants|||Number
1423189|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Change From Baseline in Heart Rate and Blood Pressure in Part B|Blood pressure and heart rate were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to G3 or G4 occurred. Blood pressure measurement included systolic blood pressure (SBP, millimeters of mercury [mmHg]) and diastolic BP (DBP). Heart rate is the measure of heart beats per minute (bpm). Changes in heart rate, either decrease to <60 bpm, change to normal or no change, or increase to >100 bpm are presented.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population|||Participants|||Number
1423190|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade Change From Baseline in the Indicated Hematology Parameters in Part B|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Hematology parameters included: lymphocytes decreased, total neutrophils, hemoglobin decreased, white blood cell counts, platelet counts, monocytes, mean corpuscular hemoglobin concentration (MCHC), eosinophils, basophils, mean corpuscular hemoglobin, mean corpuscular volume, red blood cell count, hematocrit, and reticulocytes.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.|||Participants|||Number
1423191|NCT01072175|Primary|Number of Participants With the Indicated Worst-case Grade (G) Change From Baseline in the Indicated Clinical Chemistry Parameters in Part B|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. For clinical chemistry parameters that were not graded according to NCI CTCAE criteria, changes above (High) and below (Low) the normal range were evaluated. Clinical chemistry parameters included: hyponatremia, gamma glutamyltransferase (GGT), phosphorous inorganic, alkaline phosphatase, hyperglycemia, aspartate aminotransferase (AST), hypokalemia, albumin, alanine aminotransferase (ALT), total bilirubin, hyperkalemia, hypoglycemia, creatinine, lactate dehydrogenase, urea/blood urea nitrogen (BUN), bicarbonate, chloride, creatine clearance, total protein, uric acid, and troponin T.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks)|ATP Population. Only those participants who were available at the indicated time points were analyzed.|||Participants|||Number
1423192|NCT01072175|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) in Part B|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up visit (up to approximately 103 weeks )|All Treated Participants (ATP) Population: all participants who received at least one dose of either dabrafenib or trametinib|||Participants|||Number
1423193|NCT01072175|Primary|AUC (0-t) and AUC (0-inf) of Dabrafenib and Its Metabolites in Part A|Blood samples for PK analysis of dabrafenib and its metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. AUC is defined as the area under the dabrafenib concentration-time curve as a measure of drug exposure. AUC (0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC (0-t) is defined as area under the concentration-time curve from time zero (pre-dose) to the last time of quantifiable concentration. Date are reported as geometric least square means.|Day 15|PK Population|||ng*hour/mL (ng*hr/mL)||95% Confidence Interval|Geometric Mean
1423194|NCT01072175|Primary|Maximum Plasma Concentration (Cmax) of a Single Dose of Dabrafenib Administered Alone and in Combination With Trametinib in Part A|Blood samples for PK analysis of dabrafenib and its the metabolites hydroxy-dabrafenib (GSK2285403), carboxy-dabrafenib (GSK2298683) and desmethyl-dabrafenib (GSK2167542) were obtained at pre-dose and at 1, 2, 3, 4, 6, 8, 10, and 24 hours after dabrafenib administration. From the plasma concentration-time curve, the PK parameter Cmax was determined by standard non-compartmental analysis using WinNonlin. Cmax data are reported as geometric least squares means.|Day 15|Pharmacokinetic (PK) Population: all participants who received at least one dose of either dabrafenib or trametinib and for whom a PK sample was obtained and analyzed|||Nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1423195|NCT01072149|Secondary|Change From Period Baseline in 25-hour Serial FEV1 at the End of Each 28 Day-treatment Period|Change from period Baseline in 0-25 hour serial FEV1 (0 to 25 hours) over Period Days 28-29 was measured. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Analysis was performed using a mixed effects repeated measures model with covariates of period treatment group, period Baseline, mean Baseline, period and time after dosing (nominal), in addition to time after dosing by period Baseline, time after dosing by mean Baseline, and time after dosing by period treatment interaction terms as fixed effects and participant as a random effect.|Baseline; pre-dose; 5 minutes, 15 minutes, 30 minutes, 60 minutes, and 2, 4, 6, 8, 12, 16, 20, 22, 23, 24, and 25 hours post-dose on Day 28 and Day 29 of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
1423205|NCT01072136|Primary|Evaluate Clinical Cure in Participants Not Treated Versus Participants Empirically Treated With Cefixime and Azithromycin for Mucopurulent Cervicitis (MPC).|The proportion of participants who have cleared MPC by the second follow-up visit. Clinical cure is defined as: absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 white blood cells per oil immersion field on cervical gram stain.|Visit 2 - 2 months (Day 50-70).|Per protocol. Received study product, met eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.|||percentage of participants|||Number
1423196|NCT01072149|Secondary|Change From Period Baseline in Clinic Visit Trough FEV1 at the End of Each 28-day Treatment Period|Trough FEV1 is defined as the mean of the 23- and 24-hour post-dose assessments. For each treatment period, period Baseline is defined as the mean of the -30 and -5 minute measurements taken on Period Day 1. Mean Baseline FEV1 for a given participant is defined as the mean of all available period Baseline FEV1 values. Data are presented as the mean of change from Baseline for all three treatment periods. Change from Baseline was calculated as the value at Period Day 29 minus the value at Baseline. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline, and period as fixed effects and participant as a random effect.|From Baseline to the end of each 28-day treatment period (up to 19 weeks)|ITT Population. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
1423197|NCT01072149|Primary|Time-adjusted Area Under the Curve (AUC) (i.e., Weighted Mean) for 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at the End of Each 28-day Treatment Period|FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with covariates of period treatment group, period Baseline, mean Baseline (defined as the mean of all available period Baseline FEV1 values), and period as fixed effects and participant as a random effect.|Pre-dose and the end of each 28-day treatment period (up to 19 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one dose of trial medication in any treatment period. Only those participants available at the indicated time points were assessed.|||Liters||Standard Error|Least Squares Mean
1423198|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2-3 Weeks for Each Study Arm.|"Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC's per oil immersion field on cervical gram stain."|At 2-3 weeks follow-up.|Received study product, met all eligibility criteria, and had complete outcome data at 2-3 weeks.|||percentage of participants|||Number
1423199|NCT01072136|Secondary|Determine the Clinical Cure, Partial Response and Failure Proportions for Mucopurulent Cervicitis at 2 Months for Each Study Arm.|"Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month ( Day 50-70) follow-up.|Per protocol. Received study product, met all eligibility criteria, had complete primary outcome data, and absence of any major protocol violations.|||percentage of participants|||Number
1423200|NCT01072136|Secondary|Evaluate Microbiological Cure of Mycoplasma Genitalium in Women Treated With Cefixime and Azithromycin Versus Placebo.|The proportion of participants with mycoplasma genitalium at baseline who clear mycoplasma genitalium in either the vagina or cervix at their last follow-up visit.|At 2-3 weeks and 2 month (Day 50-70) follow-up.|Participants who were positive for mycoplasma genitalium in either the cervix or vagina at baseline and who met eligibility criteria and who returned for at least one of the follow-up visits.|||participants|||Number
1423201|NCT01072136|Secondary|Explore the Role of Mycoplasma Genitalium in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 months according to mycoplasma genitalium status(positive cervical or vaginal swabs versus both negative) at 2 months.~Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas at 2-month follow-up.|||percentage of participants|||Number
1423202|NCT01072136|Secondary|Explore the Role of Bacterial Vaginosis (BV) in Persistent Mucopurulent Cervicitis (MPC).|"Proportion of participants with clinical failure, partial response, or clinical cure for mucopurulent cervicitis at 2 month follow-up according to asymptomatic bacterial vaginosis status at 2 month follow-up.~Clinical Failure:~Persistent cervical mucopus and/or easily induced cervical bleeding, and the presence of > 30 WBCs per oil immersion field on cervical gram stain OR~Signs of pelvic inflammatory disease, including cervical motion tenderness, uterine tenderness or adnexal tenderness.~Partial Response:~Persistent cervical mucopus and/or easily induced cervical bleeding and <30 WBCs per oil immersion field on cervical gram stain OR~The presence of ≥ 30 WBCs per oil immersion field on cervical gram stain in the absence of both cervical mucopus and easily induced cervical bleeding.~Clinical Cure:~• Absence of cervical mucopus and absence of easily induced cervical bleeding and < 30 WBC’s per oil immersion field on cervical gram stain."|At 2 month (Day 50-70) follow-up.|Participants who met eligibility criteria and were not positive for chlamydia, gonorrhea, cervical trichomonas or cervical mycoplasma genitalium at 2 month follow-up.|||percentage of participants|||Number
1423209|NCT01072006|Secondary|Neuropsychological Testing (Wechsler Test of Adult Reading)|This test provides an estimate of pre-morbid IQ, which is important to report so that the patient sample can be compared to other similar studies for comparable IQ level and so that pre-morbid IQ can be considered as a potential variable. There are 50 items that are each given a score of 1, so the range of scores is 0-50. The raw score is then converted into an estimated IQ score based on age and education. The scores reported below reflect this estimated IQ score, where normal IQ scores range from 75 as low average to 125 as high average.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.||||units on a scale||Standard Deviation|Mean
1423210|NCT01072006|Secondary|Psychodiagnostic Testing: Post-traumatic Stress Disorder Check List (PCL) Measures the Level of Post-traumatic Stress Disorder (PTSD) Symptoms|The PCL is a 17-item questionnaire that measures PTSD symptoms on a scale that ranges from 17-85 points. The total severity score is reported below. A higher score means a higher level of PTSD symptoms.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.||||units on a scale||Standard Deviation|Mean
1423211|NCT01072006|Primary|Functional Magnetic Resonance Imaging (fMRI) Correlation|Functional magnetic resonance imaging (fMRI) is used to measure neural activity in participants during attentional task, specifically measured as a bold signal change from rest to attention task. We then calculate the correlation between the bold signal (fMRI) and the PTSD CheckList questionnaire score. (The bold signal from fMRI indirectly reflects the brain's use of glucose, the brain's main energy source.) Correlations are reflected in an R-value, and R-values can range from 0-1, where 0 means there is no correlation (or relationship) between the two measures (here, the two measures are the fMRI brain signal and the PTSD score) and 1 means there is a perfect correlation between the two measures. A high correlation in this study would suggest that the more severe a patient's PTSD symptoms are, the harder their brain is having to work to accomplish the attention task. Separate correlations were analyzed for each group, and the overall R-value for each group is reported below.|These are chronic patients and controls who will only be tested at one time point, which corresponds to their entry into the study (after signing consent forms). Data collected at this single time point will be reported.||||r-value|||Number
1423212|NCT01071993|Primary|Primary Endpoint. Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours.|Development of CIN (Contrast-induced Nephropathy) Defined as a Postprocedure Increase in Serum Creatinine of > 0.5 mg/dL or >25% Increase From Baseline at 24 & at 48 Hours|48 hours|Participants signed consent; however, study was terminated prior to randomization||||||
1423213|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|To Day 196|Safety analyis population|||participants|||Number
1423214|NCT01071915|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|To Day 196|Safety analysis population|||participants|||Number
1423215|NCT01071915|Secondary|Cumulative Probability of no PSA Failure From Day 28 to Day 196|PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.|To Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196|||percent probability||95% Confidence Interval|Mean
1423216|NCT01071915|Secondary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196||Day 56 to Day 196|152 participants for this outcome measure is the analysis population from day 56 to day 196|||percent probability||95% Confidence Interval|Mean
1423217|NCT01071915|Secondary|Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28||To Day 28|152 participants for this outcome measure is the analysis population from day 0 to day 28|||percent||Inter-Quartile Range|Median
1423218|NCT01071915|Secondary|Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3||At day 3|Observed cases|||percent||95% Confidence Interval|Number
1423219|NCT01071915|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196||Day 28 to Day 196|152 participants for this outcome measure is the analysis population from day 28 to day 196|||percent probability||95% Confidence Interval|Mean
1423220|NCT01071798|Secondary|Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Subpopulation With Two Cycles, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 2|Subpopulation With Two Cycles with HAQ Score|||participants|||Number
1423221|NCT01071798|Secondary|Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)|In the Main Analysis Set participants with only one treatment cycle, the HAQ score was categorized for 12 subgroups as Clinically relevant improvement of HAQ-Score ≥0.3, Other or no clinical relevant change of HAQ Score, or Clinically relevant worsening of HAQ Score ≥0.3. Subgroups are defined as Anti-Cyclic citrullinated peptide (CCP) and Rheumatoid factor (RF) negative (-), positive (+), or Non-specified (n.sp.) and Seropositive Non-specified (n.sp.), Seronegative, or Seropositive.|24 weeks after starting Cycle 1|Main Analysis Set with HAQ Score|||participants|||Number
1423222|NCT01071798|Secondary|Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)||during Cycle 1, during Cycle 2, during the trial (within 12 months)||||percentage of participants|||Number
1425755|NCT01048541|Secondary|The Difference in Incidence of Adverse Events (AEs) and Adverse Device Events (ADEs)||Study period|||||||
1423223|NCT01071798|Primary|HAQ Disability Index (HAQ-DI)|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score is calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle||||units on a scale||Standard Deviation|Mean
1423224|NCT01071798|Primary|DAS28 Score|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity.|at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle||||units on a scale||Standard Deviation|Mean
1423225|NCT01071538|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|8 weeks||||beats per minute||Standard Deviation|Mean
1423226|NCT01071538|Secondary|Pain Numeric Rating Scale (20 Item)|measure of average physical pain score range 0-20 Higher scores indicate worse outcome|8 weeks||||units on a scale||Standard Deviation|Mean
1423227|NCT01071538|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 – 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 – 50, with lower scores representing lower levels of negative affect."|8 weeks||||units on a scale||Standard Deviation|Mean
1423228|NCT01071538|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|8 weeks||||units on a scale||Standard Deviation|Mean
1423229|NCT01071538|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|8 weeks||||units on a scale||Standard Deviation|Mean
1423230|NCT01071538|Primary|Blood Pressure|Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.|8 weeks||||mm Hg||Standard Deviation|Mean
1423231|NCT01071538|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity theoretical scale range 0-60 Lower values represent better outcome|8 weeks||||units on a scale||Standard Deviation|Mean
1423232|NCT01071512|Secondary|Change Over Time in Normalized Hippocampal Volume|Measured on MRI scan|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing all treatment|||mL||Standard Deviation|Mean
1423233|NCT01071512|Secondary|Change Over Time in Normalized Thalamic Volume|Measured on MRI scan|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing all treatment|||mL||Standard Deviation|Mean
1423234|NCT01071512|Secondary|Change Over Time in Brain Parenchymal Fraction|Measured based on MRI scan on a 3T Phillips scanner. This is a measure of brain atrophy (i.e., brain volume loss) with lower values indicating greater atrophy (possible range 0-1).|Baseline, 48 weeks, 96 weeks|Summary statistics are based on subjects completing treatment|||units on a scale||Standard Deviation|Mean
1423235|NCT01071512|Secondary|Change Over Time in Retinal Nerve Fiber Layer Thickness|Retinal Nerve Fiber Layer (RNFL) thickness was measured using spectral domain OCT scans by a trained technician. Scans were performed without pupil dilation.|Baseline, 24, 48, 72, and 96 weeks|Summary statistics are provided based on subjects completing all treatment|||micrometer||Standard Deviation|Mean
1423236|NCT01071512|Primary|Change in Cognitive Function Over Time|Cognitive function was assessed using the oral version of the Symbol Digit Modalities Test (SDMT). The number of correct responses in 90 seconds was recorded (possible range 0-110). For analysis, SDMT scores were converted to z-scores using published age and education based norms. A negative z-score indicates a SDMT score below the mean based on the age and education based norms, for example a z-score of -2 = 2 standard deviations below the mean; a positive z-score indicating a score above the mean. Higher scores indicate better cognitive function.|Baseline, 48 weeks, 96 weeks|Summary statistics are based on the 15 subjects who completed treatment|||units on a scale||Standard Deviation|Mean
1423237|NCT01071395|Secondary|Safety Monitoring Will be Operative Throughout the Study||18 months|||||||
1423238|NCT01071395|Secondary|Correlations Between Scale Values and Clinical Global Impressions-Severity (CGI-s) and Correlations Between Scale Changes and Clinical Global Impression of Change (CGI-c)||18 months|||||||
1423239|NCT01071395|Secondary|Correlations Among the Scales||18 months|||||||
1423240|NCT01071395|Secondary|If Sufficient Number Are Maintained on 200 mg/Day, Differences in Change Scores Between 200 mg/Day and 300 mg/Day Amantadine. (This Analysis Will be BL vs End of Study)||18 months|||||||
1423241|NCT01071395|Secondary|Change Score Differences Between Week 4 and 8 to Measure Stability of Scales Over Two Visits on Stable Doses of Amantadine or Placebo||18 months|||||||
1423242|NCT01071395|Secondary|Differences in Slope From Baseline (BL) to End of Study (Data Will Include the 4 Week Scores) Between Placebo and Amantadine to Determine Which Scales Demonstrate Sensitivity Across Time.||18 months|||||||
1423243|NCT01071395|Primary|The Investigators Will Assess Effect Size With Each Scale for Detecting Change From Baseline and Change Between Amantadine and Placebo; Allowing Assessment of Sensitivity and Specificity for Each Scale Based on Receiver Operator Characteristics (ROC).|Analyses of primary outcome measures tested sensitivity to change in dyskinesia (time effect) as well as sensitivity to differences in treatment effect (time-by-treatment interaction). These analyses were conducted using repeated-measures ANOVA (RM-ANOVA) or nonparametric analyses (Friedman’s ANOVA with follow-up Wilcoxon tests). The RM-ANOVAs tested for changes in scale scores over baseline, week 4, and week 8 visits across the entire sample (time effect), as well as differences in these changes over time between treatment groups (time-by-treatment interaction). Effect size of time to change was compared using a partial eta-square estimate of effect size. An eta-squared less than or equal to 0.01 is considered small; 0.06 is considered medium; and, 0.14 is considered large.|18 months||||unitless|||Number
1423244|NCT01071356|Secondary|Addiction Severity Index|Addiction Severity Index – Lite (ASI) is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 – 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.|Baseline, 2-,4-, and 6-month follow up||||units on a scale||Standard Error|Mean
1423245|NCT01071356|Primary|Methamphetamine Days of Abstinence : Proportion of Days Abstinent|The proportion of days abstinent from methamphetamine was represented by univariate averages at each interview of the overall adjusted longitudinal treatment effects for each of the Standard (SMI) and Intensive (IMI) conditions. For example, a baseline average of 0.55 at baseline represents that study participants were abstinent, on average 55% of the days measured.|Weekly while in treatment (9 weeks) and 4 and 6 month follow up||||proportion of days abstinent||Standard Error|Mean
1423246|NCT01071317|Secondary|Number of Participants Who Returned to the Emergency Department for Management of Headache|We report the number of patient who returned to the emergency department for management of headache|1 month after study enrollment|Two patients in each arm were lost to followup.|||Participants|||Count of Participants
1423247|NCT01071317|Secondary|Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale|Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable|1 month after study enrollment|Two patients in each arm were lost-to-follow-up. One patient in Typical Care did not answer this question.|||Participants|||Count of Participants
1423248|NCT01071317|Secondary|Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale|Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied.|1 month after study enrollment|2 patients in each group were lost to followup. One patient in the Typical Care group did not answer the question|||Participants|||Count of Participants
1423249|NCT01071317|Primary|Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale|This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment|1 month after study enrollment|2 patients in each group were lost-to-followup|||units on a scale||95% Confidence Interval|Mean
1423250|NCT01071278|Secondary|Number of Participants Who Reported Adverse Events||Up to 22 weeks||||participants|||Number
1423251|NCT01071278|Primary|Number of Participants With Lipid Panel Control|Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).|From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22)|Results are for the Intent-to-Treat (ITT) Population. Information regarding the participation in a disease management program was not reported for 63 participants in the ITT Population.|||participants|||Number
1423252|NCT01071252|Secondary|To Assess the Time to Relapse|Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.|37 weeks|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||days||95% Confidence Interval|Median
1423253|NCT01071252|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||Percentage of Participants|||Number
1423254|NCT01071252|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Response|IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.|Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||percentage of participants|||Number
1423255|NCT01071252|Primary|Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|week 13|The full analysis set (FAS), identical to the randomized set, also consisted of all randomized patients.|||percentage of participants|||Number
1423256|NCT01071200|Secondary|Number of Cycles Cancelled Due to Risk of OHSS|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.|||cycles|||Number
1423257|NCT01071200|Secondary|Number of Participants With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS is an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, haemodynamic and metabolic complications.|Baseline (S8) until 12-18 day post-hCG and/or Week 7|Safety population included all the randomized participants who received at least one dose of the study drug.|||participants|||Number
1423259|NCT01071200|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||percentage of participants|||Number
1423260|NCT01071200|Secondary|Percentage of Participants With Pregnancy||12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||percentage of participants|||Number
1423261|NCT01071200|Secondary|Number of Transferred Embryos|Embryo transfer is the procedure in which one or more embryos are placed in the uterus or Fallopian tube.|Day 3 post-hCG (ET)|mITT population included all randomized participants who entered in the experimental phase at S8.|||embryos|||Number
1423262|NCT01071200|Secondary|Number of Obtained Embryos|Total number of obtained embryos with maximum 3 inseminated oocytes was calculated.|Day 3 post-hCG (Embryo transfer [ET])|mITT population included all randomized participants who entered in the experimental phase at S8.|||embryos|||Number
1423263|NCT01071200|Secondary|Fertilization Rate|Fertilization rate was measured as the ratio between number of fertilized oocytes and number of inseminated oocytes (maximum 3).|12-18 day post-hCG and/or Week 7|mITT population included all randomized participants who entered in the experimental phase at S8.|||ratio||Standard Deviation|Mean
1423264|NCT01071200|Secondary|Mean Number of Mature Oocytes (Metaphase II)|Mean number of metaphase II oocytes was counted for participants undergoing ovum pick up for IntraCytoplasmic Sperm Injection (ICSI). ICSI is a procedure in which a single spermatozoon is injected into the oocyte cytoplasm. Metaphase II stage of the oocyte was classified as the time at which the first polar body was observed microscopically. Metaphase II oocytes are a sub-group of the total number of oocytes.|34-36 hours post-hCG (OPU)|"mITT population included all randomized participants who entered in the experimental phase at S8. Here N represents those participants undergoing ICSI whose oocytes were assessed for maturity (Metaphase II) using a microscope."|||Metaphase II Oocytes||Standard Deviation|Mean
1423265|NCT01071200|Secondary|Mean Total Number of Retrieved Oocytes|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was counted. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-36 hours post-hCG (OPU)|mITT population included all randomized participants who entered in the experimental phase at S8.|||oocytes||Standard Deviation|Mean
1423266|NCT01071200|Secondary|Change From Baseline in Oestradiol (E2) Levels at Human Choriogonadotropin (hCG) Day||Baseline (S8) and hCG day|"mITT population included all randomized participants who entered in the experimental phase at S8. Here “N” represents number of participants analyzed and n represents the number of participants with plasma E2 levels at specified time points for respective treatment groups."|||picogram/milliter (pg/mL)||Standard Deviation|Mean
1423267|NCT01071200|Secondary|Mean Number of Ovarian Stimulation Days||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.|||Days||Full Range|Mean
1423268|NCT01071200|Secondary|Mean Total Follicle Stimulating Hormone (FSH) and Recombinant Human Luteinizing Hormone (r-hLH) Dose||Baseline (S8) until hCG day|mITT population included all randomized participants who entered in the experimental phase at S8.|||IU||Standard Deviation|Mean
1423269|NCT01071200|Primary|Total Dose of Follicular Stimulating Hormone (FSH) for Retrieved Oocytes||Baseline (Stimulation day 8 [S8]) until hCG day|"Modified intention-to-treat (mITT) population included all randomized participants who entered in the experimental phase at S8. Here N represents number of participants analyzed for this measure."|||IU||Standard Deviation|Mean
1423270|NCT01071096|Secondary|Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders|Only cytokines with a mean densimetric value 1.65 times the background grey value in a minimum of 3 patients were considered detectable. These are reported below. Values normalized to positive control array spots after background subtraction: C5/C5a, CD40 Ligand, Granulocyte Colony Stimulating Factor (G-CSF), Growth Regulated Oncogene(GRO)-alpha, Soluble Intercellular Adhesion Molecule (sICAM)-1, Interferon gamma (IFN-y), Interleukin(IL)-1alpha, 1beta, 1ra, 8, 16, 17E, & 23, Interferon Gamma-Induced Protein 10 (IP-10), Interferon-inducible T cell alpha chemoattractant (I-TAC), Macrophage Migration Inhibitory Factor (MIF), Serpin E1, and Regulated Upon Activation Normal T-cell Expressed (RANTES)|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapy|Number of Participants Analyzed is low due to some unusable samples and missing samples making comparison between months impossible. 5 Responders and 5 Non-Responders provided enough samples at all time points for comparisons.|||Florescent Units (FU)||Standard Deviation|Mean
1423271|NCT01071096|Secondary|Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline|Saliva samples collected at Baseline (at no headache or lowest level of headache), at headache attack directly before taking rescue medication and 2 hours after treating with rescue medication.|For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3||||pmol/mg total protein||Standard Deviation|Mean
1423272|NCT01071096|Secondary|Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)|CGRP Level collected each month when subject did not have a headache or was at lowest pain level of headache that month.|Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7||||pmol/mg total protein||Standard Error|Mean
1423273|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7||||days||Standard Deviation|Mean
1423274|NCT01071096|Primary|Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.|Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary.|Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7||||days||Standard Deviation|Mean
1440899|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency During the First 3 Months After Initiation||Initiation to Month 3|Full Analysis Set|||Participants|||Number
1423275|NCT01071083|Secondary|Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria.|MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.|||Percentage of subjects meeting criteria|||Number
1423276|NCT01071083|Primary|Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria.|Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5|28 Weeks|Of the randomized subjects, data from 167 subjects were used in efficacy analyses. Eight subjects were excluded from the analyses: 3 subjects had major protocol deviations and 5 subjects discontinued study participation prior to Week 4 Visit.|||Percentage of subjects meeting criteria|||Number
1423277|NCT01071070|Secondary|The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)|The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)|Baseline to 12 weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
1423278|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||beats per minute||Standard Deviation|Mean
1423279|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mm Hg||Standard Deviation|Mean
1423280|NCT01071070|Secondary|The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mm Hg||Standard Deviation|Mean
1423281|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium-phosphorus Product||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mg^2/dL^2||Standard Error|Mean
1423282|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Calcium||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||mg/dL||Standard Error|Mean
1423283|NCT01071070|Secondary|The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value||Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||pg/mL||Standard Error|Mean
1423284|NCT01071070|Secondary|The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL|The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL|Baseline to 12 Weeks|The analysis was based on the intent-to-treat (ITT) population, which consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
1423285|NCT01071070|Primary|The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels|The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values|Baseline to 12 Weeks|The analysis was based on the per-protocol population, which consisted of all randomized participants who completed at least 6 weeks of treatment and met the conditions that defined the per-protocol population.|||participants|||Number
1423286|NCT01071044|Secondary|Clinical Global Impression (Severity)|The Clinical Global Impression (Severity) is a one-item clinician-rated measure. The item is a likert scale on which the clinician rates the subject based on perceived severity of psychopathology, with higher numbers indicating higher severity. In this study, we compared the mean change in severity from baseline to endpoint.|Every visit|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1423287|NCT01071044|Secondary|Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS)|The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared mean change in ADHD-RS total score from baseline to endpoint of the study.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1423288|NCT01071044|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|"The Fibromyalgia Impact Questionnaire (FIQ) is an assessment that quantifies the impact of fibromyalgia on an individual, including questions on pain level, fatigue, sleep disturbance, and psychological distress, among others. The score range is 0 to 100, with higher number indicating higher Fibromyalgia severity/impact.~Below, we compare the mean change in the Fibromyalgia Impact Questionnaire (FIQ) from baseline to week 6 between LDX and placebo treated patients."|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1423323|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening|There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
1423289|NCT01071044|Secondary|Short Form McGill Pain Questionnaire|The McGill Pain Questionniare (Short Form) consists of 15 pain descriptors (11 sensory; 4 affective) which are rated on an intensity scale. 0 = none, 1 = mild, 2 = moderate or 3 = severe. The sum of the intensity scores of the words chosen for sensory, affective and total descriptors are added for a total score. The score range is 0-45. In this study, we compared the change in the Short Form McGill Pain Questionnaire (SF-MPQ) from baseline to week 6 between LDX and placebo treated patients.|Every 2 weeks|All participants were included in analysis.|||Scores on a scale||Standard Deviation|Mean
1423290|NCT01071044|Secondary|Hamiliton Anxiety Inventory|The Hamilton Anxiety Scale is a 14-items clinician-rated scale designed to measure anxiety severity. Each of the 14 items is scored from 0 (symptom not persent) to 4 (severe symptom). The total range is 0-56. A total score of less than 17 indicates mild severity, 18-24 indicates mild to moderate severity, and a score of 25-30 indicates moderate to severe symptoms. In this study, we compared the mean change in the Hamilton Anxiety scale from baseline to week 6 between LDX and placebo-treated patients.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1423291|NCT01071044|Secondary|Fatigue Severity Scale (FSS)|The Fatigue Severity Scale is designed to measure the impact of fatigue on the life of the subject. It is a nine-question likert scale survey with a raw score range of 0-63. Scores of 36 and above indicate significant fatigue. In this study, we compared the mean change in the Fatigue Severity Scale (FSS) from baseline to endpoint between LDX and placebo treated patients.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1423292|NCT01071044|Primary|BRIEF-A|The BRIEF-A (Behavior Rating Inventory of Executive Function-- Adult Form) is comprised of the following sub-scales: Metacognition Index, Behavioral Regulation Index, Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organziation of Material. These subscales are summed to provide the GEC or Global Executive Composite. Listed below are the mean improvement scores on the GEC index from baseline to endpoint. The Global Executive Composite raw score range is 70-182, with higher scores indicating more compromised executive functioning. The scores listed in the table depict mean improvement on the GEC from the beginning to the end of the study.|Every 2 weeks|All participants were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1423293|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 12, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
1423294|NCT01070979|Secondary|Change From Baseline in Total Urogenital Symptom Score, Week 8, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 8|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
1423295|NCT01070979|Secondary|Mean Change From Baseline in Total Urogenital Symptom Score, Week 4, ITT Population|Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
1423296|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 12, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
1423297|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 12, ITT Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 12|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Hot Flush Count||Standard Error|Least Squares Mean
1423298|NCT01070979|Secondary|Mean Change From Baseline in the Severity of Moderate to Severe Hot Flushes, Week 4, ITT Population|Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes.|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Score||Standard Error|Least Squares Mean
1423299|NCT01070979|Primary|Mean Change From Baseline in the Number of Moderate to Severe Hot Flushes, Week 4, ITT (Intention to Treat) Population|Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep|Baseline to Week 4|Intention to Treat (ITT) with Last Observation Carried Forward (LOCF)|||Change in Hot Flush Count||Standard Error|Least Squares Mean
1423300|NCT01070966|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides[TG]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.|Baseline and up to 5 years||||percentage change||Standard Deviation|Mean
1423301|NCT01070966|Primary|Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation|Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.|Up to 14 days after the treatment discontinuation||||Percentage of Participants|||Number
1423302|NCT01070953|Primary|Overall Efficacy Evaluation of EZETROL®|Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.|Baseline to 4 weeks|3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded|||participants|||Number
1423303|NCT01070953|Primary|Mean Percent Change From Baseline to Treatment in Lipid Parameters|The mean percent change from baseline to treatment in lipid parameters (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides[TG]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.|Baseline to 4 weeks|"3,309 subjects were analyzed for the efficacy~evaluation; 227 of the enrolled subjects did not complete the study and were excluded"|||percentage of change||Standard Deviation|Mean
1423304|NCT01070953|Primary|Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation|Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.|Up to 14 days after treatment discontinuation||||participants|||Number
1423305|NCT01070888|Primary|Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide|"Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows:~(max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))"|8 weeks||||percentage of fall in FEV1||Standard Deviation|Mean
1423306|NCT01070810|Other Pre-specified|Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency|Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L|Hospital stay, average 2 weeks||||Participants|||Count of Participants
1423307|NCT01070810|Other Pre-specified|Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency|Baseline thiamine deficiency was defined as a baseline thiamine level of ≤ 7 nmol/L|24 hours||||nmol/L||Inter-Quartile Range|Median
1423308|NCT01070810|Secondary|APACHE II Score at 24 Hours|"APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system; an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death"|24 hours|APACHE II was not available on 6 patients in each group at 24 hour mostly because of early death.|||units on a scale||Standard Deviation|Mean
1423309|NCT01070810|Secondary|Number of Participants With Shock Reversal|Shock reversal was defined as > 24 hours off all vasopressors|Hospital stay, average 2 weeks||||Participants|||Count of Participants
1423310|NCT01070810|Primary|Lactate Level 24 Hours After the First Study Medication Dose||24 hours||||mmol/L||Inter-Quartile Range|Median
1423311|NCT01070784|Secondary|Evening FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment||||Liter(L)||Standard Deviation|Mean
1423312|NCT01070784|Secondary|Morning FEV1 Measured by the Subjects at Home|The change from run-in period and daily during 52-week randomization treatment|Daily during run-in period and daily 52-week randomization treatment||||Liter(L)||Standard Deviation|Mean
1423313|NCT01070784|Secondary|Evening Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment||||Liter/minute(L/min)||Standard Deviation|Mean
1423314|NCT01070784|Secondary|Morning Peak Expiratory Flow (PEF) Measured at Home|The change from Run-in period average to 52-week randomization Treatment period average for each treatment group|Daily during run-in period and daily 52-week randomization treatment||||Liter/minute(L/min)||Standard Deviation|Mean
1423315|NCT01070784|Secondary|Health Related Quality of Life (HRQL) Based on the St. George’s Respiratory Questionnaire (SGRQ)|The change from run-in period and daily during 52-week randomization treatment average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
1423316|NCT01070784|Secondary|Rescue Medication Use|The change from run-in period and daily during 52-week randomization treatment|Daily during 52-week randomization treatment||||innhalation/day||Standard Deviation|Mean
1423317|NCT01070784|Secondary|Number of COPD Exacerbations Over the Study Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment|Daily during 52-week randomization treatment||||event|||Number
1423318|NCT01070784|Secondary|Time to First COPD Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 52-week randomization treatment||||Percentage of participants|||Number
1423319|NCT01070784|Secondary|Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization||||percentage of Baseline||Full Range|Geometric Mean
1423320|NCT01070784|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization||||percentage of Baseline||Full Range|Geometric Mean
1423321|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough|There are 5 alternatives (scored 0 to 4, 0= unaware of coughing, 4= never free of cough or need to cough). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
1423322|NCT01070784|Secondary|Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness|There are 5 alternatives (scored 0 to 4, 0= unaware of any difficulty and 4 =almost constant, present even when resting). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 52-week randomization treatment||||units on a scale||Standard Deviation|Mean
1423353|NCT01070771|Secondary|To Determine the Level of Agreement in Management Plans Regarding the Significance of Coronary Artery Narrowings When Comparing the MP Acquired by Standard Angiographic Assessment Alone and a MP Acquired Using Angiographic Assessment Plus FFR Data.|"This compared the number of vessels in which there was a discrepant result in relation to angiographically and FFR defined significance. Angiographic significance was visually assessed by operators whereas the pressure wire provided objective data as to a narrowing's significance: an FFR reading of <0.8 indicated a significant restriction in blood flow with a recommendation for revascularisation.~The difference in indication for revascularisation of each major coronary artery was also judged according to angiogram alone compared with angiogram plus FFR dtaa."|Up to hospital discharge. Most were day case procedures but no specific data relating to discharge was collected.||||participants|||Number
1423354|NCT01070771|Primary|Estimation of Number of Cases Where FFR Data Results in a Change in the Management Strategy (Number of Vessel Requiring Treatment and/or PCI vs Medical vs CABG)|This outcome measure was assessing agreement in the management plan (MP) derived from angiographic assessment alone compared to a MP derived from angiographic assessment plus the use of FFR data acquired at the time of angiography. The study assessed the proportion of cases in which the angiogram directed MP changed after FFR data were disclosed.|Up until hospital discharge. Most cases were day cases but no specific data relating to length of stay collected.||||participants|||Number
1423355|NCT01070693|Primary|Long-term Sequelae|Any pain at five years|5 years||||percentage of participants|||Number
1423356|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Wk 2 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1423357|NCT01070550|Secondary|Percentage of Participants With Predictive Values of Virological Response by Week 2 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Wk 2 also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 2 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
1423358|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants|||Number
1423359|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants|||Number
1423360|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of Participants|||Number
1425756|NCT01048541|Primary|Mean Residual Urine Volume|Residual urine was mesured by ultrasound measurement of bladder content after intermittent catherisation|3 catheterisations on 1 day||||mL||Standard Deviation|Mean
1423361|NCT01070550|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The percentage of participants with relapse is reported in treatment naive mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants|||Number
1423362|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Per-Protocol Population at Week 4 and Week 12|RVR defined was as VR by Week 4, mRVR was defined as mVR by Week 4, cEVR was defined as VR by Week 12, but no RVR, mcEVR was defined as mVR by Week 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Week 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|At Week 4 and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.|||Participants|||Number
1423363|NCT01070550|Secondary|Number of Participants With Response by Disjoint Categories by Genotype in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Week 4, Modified rapid virological response (mRVR) was defined as mVR by Week 4, Complete early virological response (cEVR) was defined as VR by Week 12, but no RVR, Modified complete early virological response (mcEVR) was defined as mVR by Week 12, but no mRVR, Partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Week 12, but no RVR and no cEVR, Modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Week 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a.|Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.|||Participants|||Number
1423364|NCT01070550|Secondary|Percentage of Participants With At Least 1 Log Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1423365|NCT01070550|Secondary|Percentage of Participants With At Least 1-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
1423366|NCT01070550|Secondary|Percentage of Participants With At Least a 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a.|Week 2, Week 4, and Week 12|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1423367|NCT01070550|Secondary|Percentage of Participants With At Least 2-logarithm10 Drop in Hepatitis C Virus Deoxyribonucleic Acid by Genotype in Modified All-Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a.|At Week 2, Week 4, and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
1423397|NCT01070329|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result, Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
1423368|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Per-Protocol Population Over Time|Modified virological response is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1423369|NCT01070550|Secondary|Percentage of Participants With Modified Virological Response by Genotype in Modified All-Treated Population Over Time|Modified virological response was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
1423370|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Per-Protocol Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1423371|NCT01070550|Secondary|Percentage of Participants With Virological Response by Genotype in Modified All-Treated Population Over Time|Virological response was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, and Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
1423372|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Per-Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria. n = the number of participants analyzed at a given time point.|||Percentage of participants||95% Confidence Interval|Number
1423373|NCT01070550|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and Week 12 on Modified Sustained Virological Response by Genotype After Treatment Initiation in Modified All-Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population. n = the number of participants analyzed at a given time point.|||Percentage of participants||95% Confidence Interval|Number
1423374|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Per-Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1423375|NCT01070550|Primary|Percentage of Participants With Modified Sustained Virological Response by Genotype in Modified All-Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result of <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
1425757|NCT01048502|Secondary|Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.||baseline and 6-8 weeks||||pg/mL||Standard Deviation|Median
1423376|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Per-Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion/exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1423377|NCT01070550|Primary|Percentage of Participants With Sustained Virological Response by Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive hepatitis C virus (HCV) mono-infected modified all-treated (mTRT) who received PEG-IFN alfa-2a. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of peginterferon alfa-2a and ribavirin, and had at least one post-baseline HCV RNA test result. Participants with a baseline test result <50 IU/mL were excluded from the mTRT population.|||Percentage of participants||95% Confidence Interval|Number
1423378|NCT01070394|Secondary|Psychometric Validation of AMSES|To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.|Weeks 0-12||||Cronbach's alpha coefficients|||Number
1423379|NCT01070394|Secondary|Psychometric Validation of AMRS|To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.|Weeks 0-12||||Cronbach's alpha coefficients|||Number
1423380|NCT01070394|Primary|Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)|"The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19.~Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0–54. A score of 0-16 means Unlikely to have ADHD; a score of 17-23 Likely to Have ADHD ; 24 or greater-Highly Likely to have ADHD"|12 weeks||||units on a scale||Standard Deviation|Mean
1423381|NCT01070394|Secondary|Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist|To correlate symptom rebound through a single day (assessed via the AMRS) with a self assessment of ADHD Symptoms. A Pearson's correlation coefficient will be presented. AMRS and self assessment of ADHD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.|Baseline to Week 12||||Pearson's correlation coefficient|||Number
1423382|NCT01070394|Secondary|Change in Correlation Between AMRS and TASS|To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented. AMRS and TASS scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.|Visits 0 and 12||||Pearson's correlation coefficient|||Number
1423383|NCT01070394|Secondary|Correlation Between AMRS (In Clinic) and ADHD-RS|To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. AMRS and ADHD-RD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.|Visits 0 and 12||||Pearson's correlation coefficient|||Number
1423384|NCT01070394|Secondary|Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)|The Adult ADHD Medication Smoothness of Effect Scale (AMSES) is a 6-item, frequency-based, self-report scale that was recently developed to assess the consistency and duration of effect of ADHD medication throughout the day. The AMSES compares the effectiveness of ADHD medication shortly after dosing with the effectiveness later in the day. Respondents are asked to rate how frequently the effective-ness of their medication was the same 2 hr post-dose as it was 4, 6, 8, 10, and 12 hr post-dose on a 0 to 4 scale (0 = never, 1 = rarel, 2 = sometimes, 3 = often, 4 = very often). In addition, respondents rate how frequently the delivery of their medication was consistent and smooth throughout the day on a visual analog scale ranging from 0 (never) to 100 (very often).|Visits 0 and 12||||units on a scale||Standard Deviation|Mean
1423385|NCT01070394|Secondary|Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).|To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Scoring on the AMRS based on 38 items, each scored 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe). The lowest scored units on a scale for 1 individual is 0, the highest 114. The scores reported below are Mean scores for 33 patients analyzed.|Week 0 to Week 12||||units on a scale||Standard Deviation|Mean
1423386|NCT01070381|Primary|Overall Comfort|Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1423409|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.|||Participants|||Number
1423387|NCT01070329|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline C-SSRS result.|||participants|||Number
1423388|NCT01070329|Secondary|Patient Global Impression of Improvement (PGI-I) Score at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1423389|NCT01070329|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1423390|NCT01070329|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine|Laboratory assessment of creatinine during the double-blind treatment phase. Normal creatinine ranges for males are 40.00 micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high). Normal creatinine ranges for females are 31.00 µmol/L (low) to 101.00 µmol/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.|||participants|||Number
1423391|NCT01070329|Other Pre-specified|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."|||kilograms (kg)||Standard Error|Least Squares Mean
1423392|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1423393|NCT01070329|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."|||mm Hg||Standard Error|Least Squares Mean
1423394|NCT01070329|Other Pre-specified|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intent-to-treat (ITT) population with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."|||beats per minute (bpm)||Standard Error|Least Squares Mean
1423395|NCT01070329|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1423396|NCT01070329|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
1423398|NCT01070329|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1423399|NCT01070329|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1423400|NCT01070329|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1423401|NCT01070316|Primary|Number of Participants Continuing Study Medication Over Time||Individual subjects will be assessed every 6 months for up to 48 months; aggregate analysis will take place at end of study||||participants|||Number
1423402|NCT01070316|Primary|Reduction in Seizure Frequency|The primary efficacy endpoint was the percentage of participants demonstrating a 50% or greater reduction in seizure frequency at the end of the maintenance phase (weeks 13-16) compared to baseline (weeks 1-4)|Baseline (Weeks 1-4), Week 16||||percentage|||Number
1423403|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 260.|||Participants|||Number
1423404|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 212.|||Participants|||Number
1423405|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 152.|||Participants|||Number
1423406|NCT01070303|Secondary|Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)|A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 104.|||Participants|||Number
1423407|NCT01070303|Secondary|Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248|The analysis population is observed cases, that is, all participants who had an IBDQ score at the visit time point.|||Scores on a scale||Standard Deviation|Mean
1423408|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.|||Participants|||Number
1423410|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.|||Participants|||Number
1423411|NCT01070303|Secondary|Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.|||Participants|||Number
1423412|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 260|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.|||Participants|||Number
1423413|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 212|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.|||Participants|||Number
1423414|NCT01070303|Secondary|Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 152|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.|||Participants|||Number
1423415|NCT01070303|Secondary|Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)|Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.|From Baseline of lead-in study to Week 104|The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.|||Participants|||Number
1423416|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.|||Participants|||Number
1423417|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)|CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation Week 212 are included.|||Participants|||Number
1423418|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in Study to Week 152|The analysis population is observed cases, that is, all participants who CDAI evaluation at Week 152 are included.|||Participants|||Number
1423419|NCT01070303|Secondary|Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 .|||Participants|||Number
1423420|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.|||Participants|||Number
1423421|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 212|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 212|||Participants|||Number
1423422|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.|||Participants|||Number
1423423|NCT01070303|Secondary|Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 of Study NCT00055497 are included.|||Participants|||Number
1423424|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 260|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 of Study NCT00055497 are included.|||Participants|||Number
1423425|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 212|Observed cases, that is, all participants who participating at Week 212 and had a CDAI measurement at that time point were included.|||Participants|||Number
1423426|NCT01070303|Secondary|Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 152|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.|||Participants|||Number
1423427|NCT01070303|Primary|Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.|Week 104|The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 are included.|||Participants|||Number
1423428|NCT01070173|Primary|Acylated Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.|||pg/mL||Standard Deviation|Mean
1423429|NCT01070173|Primary|Total Ghrelin Level||Will be measured with baseline screening labs at enrollment.|All participants.|||pg/mL||Standard Deviation|Mean
1423430|NCT01070043|Secondary|Number of Participants With Adverse Events During Double-blind Phase||8 weeks|Safety population included all patients who received at least one study medication during the study period.|||Participants|||Number
1423431|NCT01070043|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1440900|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at end of treatment|Up to Month 12|Full Analysis Set|||Participants|||Number
1423432|NCT01070043|Secondary|Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours|Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1423433|NCT01070043|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1423434|NCT01070043|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement|Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.|Baseline and 8 weeks|The Intent-to-Treat (ITT) Population includes all participants having taken at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1423435|NCT01069939|Secondary|Number of Participants With Adverse Events|Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.|Up to 70 weeks at the longest|All participants who received any study drug were included in this analysis.|||Participants|||Number
1423436|NCT01069939|Secondary|Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48|"The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)||||Participants|||Number
1423437|NCT01069939|Secondary|Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48|"The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of Nausea and/or Vomiting at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
1423438|NCT01069939|Secondary|Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week|"The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of abdomen enlarged feeling at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
1423439|NCT01069939|Secondary|Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48|"The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of anorexia at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
1423440|NCT01069939|Secondary|Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.|"The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of heartburn at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
1423441|NCT01069939|Secondary|Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48|"The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened."|Up to 48 weeks (Baseline to last measurement)|Participants who had the measurements of epigastric pain at baseline and post-dose up to 48 weeks were included in this analysis.|||Participants|||Number
1423442|NCT01069939|Secondary|Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48.|Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not.|12, 24, 36 and 48 weeks|Patients with endoscopy were included in the analyses at 12, 24, 36 and 48 weeks after randomisation.|||Participants|||Number
1423443|NCT01069939|Secondary|Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48|Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion.|Up to 48 weeks (Baseline to last measurement)|Participants who had LANZA scores at both baseline and post-dose were included into this analysis.|||Scores on a scale||Standard Deviation|Mean
1423444|NCT01069939|Primary|Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis.|Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks.|From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)|Participants not taking investigational drug were not included. In total 364 participants were included in the efficacy evaluation at the interim analysis. 24 of the 364 total participants had an occurrence of gastric and/or duodenal ulcers by the 48-week assessment.|||Participants|||Number
1423445|NCT01069900|Secondary|Bacteriological Response at the End of Treatment (EOT) Visit|Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
1423446|NCT01069900|Secondary|Clinical Response at the End-of-Treatment (EOT) Visit|Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported.|Day 5 to Day 14|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
1423447|NCT01069900|Secondary|Bacteriological Response at a ‘During Therapy’ Visit|Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
1423448|NCT01069900|Secondary|Clinical Response at a ‘During Therapy’ Visit|"Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy.~'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported."|Day 3 to Day 5|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
1423449|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported|28 to 42 days|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
1423450|NCT01069900|Secondary|Bacteriological Response at Test-of-Cure (TOC) Visit|"Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate.~'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported."|28 to 42 days|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
1423451|NCT01069900|Secondary|Clinical Response at Test-of-Cure (TOC) Visit|Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported.|28 to 42 days|Safety analysis set with subjects evaluable for this outcome|||Percentage of subjects|||Number
1423452|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Percentage of subjects|||Number
1423453|NCT01069900|Secondary|Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3|"A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Percentage of subjects|||Number
1423454|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
1423455|NCT01069900|Secondary|Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett’s method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
1423456|NCT01069900|Secondary|QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
1423457|NCT01069900|Secondary|QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3|"The QRS interval represents the time it takes for ventricular depolarization to occur. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
1423458|NCT01069900|Secondary|RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The RR interval refers to the respective time interval in the Electrocardiogram. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
1423459|NCT01069900|Secondary|PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||milliseconds||Standard Deviation|Mean
1423460|NCT01069900|Secondary|Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3|"N signifies subjects who were evaluable for the specified parameter for each arm, respectively."|Baseline (Pre-dose), Day 1, Day 3|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Beats per minute (bpm)||Standard Deviation|Mean
1423461|NCT01069900|Secondary|Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term|"Musculoskeletal adverse events were classified as following SOCs (preferred terms): injury, poisoning and procedural complications (forearm fracture, joint injury, ligament sprain, muscle strain) musculoskeletal and connective tissue disorders (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms."|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Percentage of subjects||95% Confidence Interval|Number
1423462|NCT01069900|Primary|Number of Subjects With Musculoskeletal Adverse Events||All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Subjects|||Number
1423463|NCT01069900|Primary|Number of Subjects With Clinical Cardiac Adverse Events||Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Subjects|||Number
1423475|NCT01069861|Primary|Percentage of Participants Requiring Inhaled Nitric Oxide (iNO) or Extracorporeal Membrane Oxygenation (ECMO)|Percentage of participants who required standard therapy (iNO or ECMO) after failure of study treatment.|From start of infusion (baseline) up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423464|NCT01069900|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.|Safety analysis set; All subjects (N= 451) treated with at least one dose of study medication.|||Subjects|||Number
1423465|NCT01069861|Other Pre-specified|Duration of Study Medication|The duration of the infusion was determined as per investigator’s discretion up to Day 7 or Day 14.|Baseline up to Day 14|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423466|NCT01069861|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sildenafil Metabolite (UK-103320)||Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423467|NCT01069861|Secondary|Population Pharmacokinetics of Sildenafil|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 5 and 30 minutes post-loading infusion, within 48 to 72, 96 to 120 hours during infusion, within 4 to 8, 18 to 24 and 44 to 48 hours post-maintenance infusion|||||||
1423468|NCT01069861|Secondary|Time to Receipt of Standard Therapy (Inhaled Nitric Oxide [iNO] or Extracorporeal Membrane Oxygenation [ECMO])|Time from start of treatment up to introduction of standard therapy. If participants did not receive standard therapy within 14 days after initiation of the study treatment, then Day 14 was the censoring time.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423469|NCT01069861|Secondary|Duration of Mechanical Ventilation|The number of days from the start to the stop of mechanical ventilation, if multiple ventilations occurred during the follow-up, the sum of the duration of each ventilation was used for analyses. Mechanical ventilation was defined as use of mechanical assistance or replacement of spontaneous breathing.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423470|NCT01069861|Secondary|Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to the Fraction of Inspired Oxygen (P/F) at Hour 6 and 12|The ratio of partial pressure of arterial oxygen and fraction of inspired oxygen is a comparison between the oxygen level in the arterial blood and the oxygen concentration that is breathed. It helps to determine the degree of any problems with how the lungs transfer oxygen to the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423471|NCT01069861|Secondary|Change From Baseline in Differential Saturation (Pre- And Post-ductal) at Hour 6 and 12|Differential oxygenation saturation between preductal and postductal sites as measured by pulse oximetry. A difference of greater than (>) 5 percent (%) to 10% in saturation indicates right-to-left shunt through the ductus arteriosus. Oxygenation saturation is measured as percentage of hemoglobin binding sites occupied by oxygen in the blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423472|NCT01069861|Secondary|Change From Baseline in Oxygenation Index at Hour 6 and 12|Oxygenation Index (OI) was calculated as the product of fraction of inspired oxygen (FiO2) and Mean Airway Pressure divided by partial pressure of oxygen in arterial blood [(FiO2*Mean Airway Pressure)/PaO2] measured in centimeter of water/millimeter of mercury (cmH2O/mmHg). FiO2 is the measure of oxygen concentration that is breathed. Mean airway pressure is defined as an average of the airway pressure throughout the respiratory cycle. PaO2 is the measure of oxygen level in the arterial blood.|Baseline, Hour 6, 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423473|NCT01069861|Primary|Number of Participants With Abnormal Laboratory Data|Criteria for potentially clinically significant (PCS) laboratory values: hematocrit 29.2 percent (%); white blood cell (WBC) count 5.0*10^3, lymphocyte absolute 0.88*10^3, total neutrophils absolute 12.07*10^3, eosinophils absolute 0.50*10^3 per cubic millimeter (/mm^3); calcium 6.8 milligram/deciliter (mg/dL); venous bicarbonate 47.0 milliequivalent/liter (meq/L).|Screening, once daily for 3 days, every 48 hours thereafter till the end of infusion (up to Day 14)|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423474|NCT01069861|Primary|Number of Participants With Adverse Events (AEs) Based on Severity|AE:any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE:AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience; persistent/significant disability/incapacity; congenital anomaly. Severity criteria: “mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function and severe=interferes significantly with participant's usual function”.|Baseline up to 28 days after last dose|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early study termination.||||||
1423633|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11)|Week 14|Full Analysis Set (FAS) includes all randomised subjects. For 20 subjects, values were missing.|||Subjects|||Number
1423476|NCT01069627|Secondary|Time to Overall Response of CR or PR - Time to Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; only participants with a response of CR or PR were included in the analysis.|||days||Standard Deviation|Mean
1423477|NCT01069627|Secondary|Time to Overall Response of CR or PR - Percentage of Participants With an Event|The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
1423478|NCT01069627|Secondary|Time to CR - Time To Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis.|||days||Standard Deviation|Mean
1423479|NCT01069627|Secondary|Time to CR - Percentage of Participants With an Event|The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
1423480|NCT01069627|Secondary|TTF - Time to Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than ‘Protocol Violation’ or ‘Administrative Problem’. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||days||95% Confidence Interval|Median
1423481|NCT01069627|Secondary|Time to Treatment Failure (TTF) - Percentage of Participants With an Event|The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than ‘Protocol Violation’ or ‘Administrative Problem’. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
1423482|NCT01069627|Secondary|OS - Time to Event|The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population|||days||95% Confidence Interval|Median
1423483|NCT01069627|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive.|Baseline, every 3 weeks to end-of-treatment, every 3 months during follow-up, to death or end-of-study (maximum of 36 months)|ITT population|||percentage of participants|||Number
1423484|NCT01069627|Secondary|Duration of Stable Disease - Time to Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the analysis.|||days||95% Confidence Interval|Median
1423485|NCT01069627|Secondary|Duration of Stable Disease - Percentage of Participants With an Event|Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR, PR, or SD were included in the anlaysis.|||percentage of participants|||Number
1423486|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Time to Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.|||days||95% Confidence Interval|Median
1423500|NCT01069562|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of BIS||Standard Deviation|Mean
1425758|NCT01048502|Primary|The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).||randomization and 8 weeks post||||pg/mL||Inter-Quartile Range|Median
1423487|NCT01069627|Primary|Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)|The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants||95% Confidence Interval|Number
1423488|NCT01069627|Secondary|Duration of Overall Response of CR or PR - Percentage of Participants With an Event|The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR or PR were included in the analysis.|||percentage of participants|||Number
1423489|NCT01069627|Secondary|Duration of CR - Time to Event|The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a CR were included in the analysis|||days||95% Confidence Interval|Median
1423490|NCT01069627|Secondary|Duration of CR - Percentage of Participants With an Event|Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; only participants with a best overall response of CR were included in the analysis.|||percentage of participants|||Number
1423491|NCT01069627|Secondary|TTP - Time to Event|TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||days||95% Confidence Interval|Median
1423492|NCT01069627|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants|||Number
1423493|NCT01069627|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months|Intent-to-Treat (ITT) Population: all participants who signed the informed consent form and were assigned a study patient number; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.|||percentage of participants||95% Confidence Interval|Number
1423494|NCT01069562|Secondary|INTRA OPERATIVE PHENYLEPHRINE USED|The amount of phenylephrine used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||.µg/kg||Standard Deviation|Mean
1423495|NCT01069562|Secondary|Intra Operative Adrenaline Used|The amount of adrenaline used during the procedure|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||µg/kg||Standard Deviation|Mean
1423496|NCT01069562|Secondary|Fentanyl Used|The total amount of fentanyl that was used during the procedure.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||µg/kg||Standard Deviation|Mean
1423497|NCT01069562|Secondary|Intra-operative Awareness|The number of patients who were able to recall the intra-operative events when assessed postoperatively. This was assessed by a structured protocol|3 days (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||participants|||Number
1423498|NCT01069562|Secondary|Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of time||Standard Deviation|Mean
1423499|NCT01069562|Secondary|Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline|The duration of time heart rate remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of time||Standard Deviation|Mean
1423501|NCT01069562|Secondary|Median Absolute Performance Error (MDAPE)|The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage deviation of absolute BIS||Standard Deviation|Mean
1423502|NCT01069562|Secondary|Median Performance Error (MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either ‘+’ or ‘_’ indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during isoflurane anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage deviation of BIS from target||Standard Deviation|Mean
1423503|NCT01069562|Primary|Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50|The duration of time depth of anesthesia was maintained in the recommended range (as measured by BIS) during the period isoflurane (general anesthetic) was administered to the study population. This value expressed as percentage is the primary outcome. BIS is an objective measure of depth of anesthesia derived from statistical(bispectral) analysis of electroencephalographic waves. BIS ranges from 0 to 100. It decreases monotonically from 100 in the awake state to lower values with sedation and anesthesia.|8 hours (approximately)|All the patients who were randomized completed the study protocol and were included for analysis|||percentage of time||Standard Deviation|Mean
1423504|NCT01069523|Secondary|Clinical Global Impression- Improvement|Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse|Week 4 of study||||units on a scale||Standard Deviation|Mean
1423505|NCT01069523|Primary|Dupaul ADHD Rating Scale|54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.|Baseline and Follow up||||units on a scale||Standard Deviation|Mean
1423506|NCT01069484|Secondary|Urinary Incontinence (Positive Pad Test)|"Urinary incontinence assessed by pad test, as described by Mørkved and Bø (1997). The cutoff value for a positive test was 2 gram.~After voiding, the women drank one litre of water. Thirty minutes later they wore a pre-weighted pad and performed a stress test as follows:~Jumping up and down with maximal intensity for 30 seconds.~Jumping with the legs in alternate abduction and adduction (Jumping Jacks) with maximal intensity for another 30 seconds.~Coughing as hard as possible three times. As in the study by Mørkved and Bø (1997), a positive pad-test was set to a cut-off of 2 gram of leakage."|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.|||participants|||Number
1423507|NCT01069484|Primary|Urinary Incontinence (Prevalence)|Urinary incontinence was assessed by The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form questionnaire, www.iciq.net). Women were considered as incontinent if they reported to leak urine (yes/no) at any frequency.|6 months postpartum (end of intervention)|Primiparous women who delivered a singleton baby vaginally after more than 32 weeks of gestation. They had to have Scandinavian language skills, no severe perineal tearing, no prior abortion or stillbirth after 16 weeks of gestation, and no illnesses interfering with the ability to follow-up.|||participants|||Number
1423508|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)|"The CDAI was calculated with the equation:~CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient’s Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician’s Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104)."|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||units on a scale||Standard Deviation|Mean
1423509|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||units on a scale||Standard Deviation|Mean
1423510|NCT01069419|Secondary|Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)|Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||units on a scale||Standard Deviation|Mean
1423511|NCT01069419|Primary|Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6|"The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient’s Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints.~For the analysis, DAS28 values were categorized into the following groups:~DAS28 < 2.6: clinical remission~DAS28 from 2.6 to ≤ 3.2: low disease activity~DAS28 from > 3.2 to 5.1: moderate disease activity~DAS28 > 5.1: high disease activity"|From Baseline to Visit 9 (around Week 104)|Full Analysis Set (FAS) using Non-Responder Imputation (NRI). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.|||percentage of participants||95% Confidence Interval|Number
1423512|NCT01069354|Secondary|Assess Subject Preference to Pain|"2 questions were asked of 101 subjects: 1) Was one treatment less painful than the other? and 2) Was the difference in pain levels significant enough to affect your preference for one treatment over the other?~Only those participants responding yes to these 2 questions about pain and preference for treatment are reported in the table below."|Immediately after injection (Time 0)||||"participants responding yes"|||Number
1423513|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|4 weeks post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
1423514|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|2 weeks post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
1423515|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|1 week post injection|Two subjects missed their Week 1 visit.|||units on a scale||Standard Deviation|Mean
1423516|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|60 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
1423517|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|45 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
1423518|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|30 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
1423519|NCT01069354|Secondary|Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection|A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.|15 minutes post injection|One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses.|||units on a scale||Standard Deviation|Mean
1423520|NCT01069354|Secondary|Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS|"In this split-face study, a clinically meaningful difference in pain was defined as a 2-cm reduction (i.e., subject reports at least 2-cm less pain on a 10-cm VAS) in the Radiesse® Mixed with Lidocaine NLF when compared to the Radiesse® without Lidocaine NLF."|Immediately after injection (Time 0)|In this split-face study, participants received both treatments (i.e., 1 NLF with Radiesse Mixed with Lidocaine and 1 NLF with Radiesse without Lidocaine). Results are presented as the number of participants reporting at least a 2-cm lower pain VAS score in the Radiesse Mixed with Lidocaine NLF when compared to the Radiesse without Lidocaine NLF.|||participants|||Number
1423521|NCT01069354|Primary|Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)|"Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain).~In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero."|Immediately after injection (Time 0)||||units on a scale|Nasolabial folds|Standard Deviation|Mean
1423522|NCT01069341|Secondary|Mean Change in Intraocular Pressure (IOP)|Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12.|at months-3,7, and 12|All subjects' data was analyzed, no subjects were excluded|||mmHg||Standard Deviation|Mean
1440901|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 12|Month 12|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1423530|NCT01069289|Secondary|St George’s Respiratory Questionnaire (SGRQ) Total Score|The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
1423531|NCT01069289|Secondary|Use of Rescue Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||inhalations/day||Standard Deviation|Mean
1423532|NCT01069289|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
1423533|NCT01069289|Secondary|Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
1423534|NCT01069289|Secondary|Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||units on a scale||Standard Deviation|Mean
1423535|NCT01069289|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Nights with symptoms||Standard Deviation|Mean
1423536|NCT01069289|Secondary|Evening Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter (L)||Standard Deviation|Mean
1423537|NCT01069289|Secondary|Morning Forced Expiratory Volume in One Second (FEV1)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter (L)||Standard Deviation|Mean
1423538|NCT01069289|Secondary|Total Number of Day With Exacerbation|Total number of days with COPD exacerbation for each treatment group|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||days|||Number
1423539|NCT01069289|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter/minute (L/min)||Standard Deviation|Mean
1423540|NCT01069289|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period and daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||Liter/minute (L/min)||Standard Deviation|Mean
1423541|NCT01069289|Secondary|Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 12-week randomization treatment|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||event|||Number
1423542|NCT01069289|Secondary|Percentage of Participants With Exacerbations|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.|Daily during 12-week randomization treatment|The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of participants|||Number
1423615|NCT01068717|Primary|Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||Hours||Standard Deviation|Mean
1423543|NCT01069289|Secondary|1 Hour Post-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
1423544|NCT01069289|Secondary|Pre-dose Forced Vital Capacity (FVC)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
1423545|NCT01069289|Secondary|1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
1423546|NCT01069289|Primary|Pre-dose Forced Expiratory Volume in One Second (FEV1)|The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group|Before randomization, 0, 4, 8 and 12 weeks after randomization|The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.|||percentage of Baseline||Full Range|Geometric Mean
1423547|NCT01069185|Secondary|Mechanical Ventilation Length as Days.|Number of days under mechanical ventilation during ICU hospitalization length|Every day while patient really is intubated.||||Days||Inter-Quartile Range|Median
1423548|NCT01069185|Primary|Primary Composite End Point|All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.|Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .||||event|suctioning||Number
1423549|NCT01069172|Secondary|Cumulative Dissipated Energy (CDE)|"CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:~CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)~0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification."|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of CDE was done by eye group.|||CDE||Standard Deviation|Mean
1423550|NCT01069172|Primary|Deviation From Intended Capsulotomy Diameter|Capsulotomy diameter measured during surgery for both the experimental and control groups.|Day of Surgery|29 subjects had FS laser surgery in one eye (29 FS surgery eyes) and CCC with U/S surgery in their fellow eye (29 CCC surgery eyes). Analysis of capsulotomy size was done by eye group.|||μm||Standard Deviation|Mean
1423551|NCT01069120|Primary|To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs)||During two 4 month treatment periods|||||||
1423552|NCT01069003|Primary|Incidence of Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)||||Percentage of participants|||Number
1423553|NCT01069003|Primary|Percentage of Participants of Incidence of ARC Definite or Probable Stent Thrombosis (ST) for Randomized Subjects|"All definite and probable Stent Thrombosis (ST) are adjudicated by an independent committee according to the definition based on Academic Research Consortium (ARC)~Definite is defined as angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region and at least 1 of the following: Acute ischemic symptoms, Ischemic ECG changes, Elevated cardiac biomarkers~Probable defined as any unexplained death within the first 30 days of procedure and any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause"|Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)||||percentage of participants|||Number
1423554|NCT01069003|Primary|Percentage of Participants With Composite of All Death, Target Vessel Myocardial Infarction (MI) and Stroke (Defined as MACCE) for Randomized Subjects||Placebo and Thienopyridine 12 - 30 months; Surveillance Arm (0 - 24 months)||||Percentage of participants|||Number
1423555|NCT01068964|Primary|The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4|The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.|Baseline, Week 4|Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1423585|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||hr||Standard Deviation|Mean
1423556|NCT01068912|Primary|Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza|"Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. Alleviated was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours."|22 weeks|The primary analysis population for efficacy analyses was the ITTI Population (N=333), defined as all patients who received at least 1 dose of study drug with any available efficacy data after randomization and who tested positive for influenza A or B by PCR assay or culture tests on Day 1 using determinations.|||hours||95% Confidence Interval|Median
1423557|NCT01068860|Secondary|Number of Participants Reporting Death, Serious Adverse Events (SAEs) and Adverse Events (AEs) Above 5% Frequency, From Baseline to 4 Weeks|An adverse event is any unwanted event, whether related to study drug or not occuring during the study period. A Serious Adverse Event (SAE) is an event resulting in death, requiring or prolonging hospitalization, a congenital anomaly or other important medical event. AEs and SAEs were recorded at each visit.|Baseline, 4 weeks|Safety Population consisted of all participants who received at least one dose of study medication and had at least one post-baseline safety assessment.|||participants|||Number
1423558|NCT01068860|Secondary|Mean Change in Peak Plasma C-peptide Level, From Baseline to 4 Weeks|"Change in mean peak plasma C-peptide level measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||nmol/L||Standard Error|Least Squares Mean
1423559|NCT01068860|Secondary|Mean Change in Peak Plasma Insulin, From Baseline to 4 Weeks|Change in mean peak plasma Insulin level as measured from Baseline to 4 weeks of treatment. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/L||Standard Error|Least Squares Mean
1423560|NCT01068860|Secondary|Mean Change in Peak Plasma Glucose, From Baseline to 4 Weeks|"Change in peak plasma glucose level as measured from Baseline to 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
1423561|NCT01068860|Secondary|Mean Change in Post-prandial Glucose Area Under the Curve (AUC)0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol*hr/L||Standard Error|Least Squares Mean
1423562|NCT01068860|Secondary|Mean Change in C-peptide Area Under the Curve (AUC), 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||nmol*hour/L||Standard Error|Least Squares Mean
1423563|NCT01068860|Secondary|Mean Change in Insulin Area Under the Curve (AUC) 0-4 Hours, From Baseline to 4 Weeks|Blood samples were drawn after a test meal at 0, 15, 30, 45, 60, 90, 120, 180 and 240 min. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab vs placebo within each T2DM group. The mixed model didn't include the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol*hour/L||Standard Error|Least Squares Mean
1423564|NCT01068860|Secondary|Mean Change in Absolute Glucose Level at 2 Hours, From Baseline to 4 Weeks|"Change in glucose level measured after 2 hours of fasting. Blood sample was drawn at 0 minutes and at 240 minutes.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
1423586|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||hr||Standard Deviation|Mean
1423565|NCT01068860|Secondary|Mean Change in Fasting Glucose Disposition Index(GDI)1 and Index 2, From Baseline to 4 Weeks|GDI 1 is the product of insulin sensitivity index (Si)during the 1st phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR).GDI 2 is the product of (Si)during the 2nd phase of insulin secretion and β-cell function as measured by the acute insulin response (AIR). A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT group.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||number||Standard Error|Least Squares Mean
1423566|NCT01068860|Secondary|Mean Change in Quantitative Insulin Sensitivity Check Index (QUICKI) Score, From Baseline to 4 Weeks|"The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects the mean score ± SE is 0.366 ± 0.029.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population."|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||number||Standard Error|Least Squares Mean
1423567|NCT01068860|Secondary|Mean Change in Fasting Plasma Insulin, From Baseline to 4 Weeks|"Change in Fasting Insulin level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/L||Standard Error|Least Squares Mean
1423568|NCT01068860|Secondary|Mean Change in Fructosamine, From Baseline to 4 Weeks|"Change in Fructosamine Level taken from plasma, measured at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
1423569|NCT01068860|Secondary|Mean Change in Fasting Plasma Glucose, From Baseline to 4 Weeks|"Change in Fasting Glucose Level measured from plasma taken at Baseline and after 4 weeks of treatment.~A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population"|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||mmol/L||Standard Error|Least Squares Mean
1423570|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-4 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose, insulin and C-peptide at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population.|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
1423571|NCT01068860|Secondary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 2-4 Hours, From Baseline to 4 Weeks|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include participants from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
1423572|NCT01068860|Primary|Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks.|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal.A mixed model with treatment fitted as fixed effect, and population and the interaction of population and treatment fitted as random effects were used for the comparison of Canakinumab versus placebo within each T2DM population. The mixed model did not include patients from the IGT population|Baseline, 4 weeks|Participants from the full analysis set who participated in the meal challenge and who had at least 1 post-baseline absolute glucose measurement at 2 hours.|||pmol/min/m^2/mmol/L||Standard Error|Least Squares Mean
1423573|NCT01068821|Secondary|Number of Participants Reporting a Neurologic Deficit in Extremities After Surgery|The neurologic deficit was assessed as follows: Patients' postoperative care was unchanged from routine for this study. Any postoperative complaints regarding limb pain or weakness or numbness were recorded and assessed with neurologic exam to determine sensation or motor components. Absence of resolution was documented.|postoperative day 1 and postoperative week 3-8|Participants were analyzed per protocol if they returned for postoperative followup (59 of 60 were analyzed)|||participants|||Number
1427103|NCT01033942|Primary|Acceptability of Size of Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||Participants|||Number
1423574|NCT01068821|Primary|Amount of Patient Movement on the Operating Room Table|Patients undergoing gynecologic surgery require steep (30 to 45 degree) Trendelenberg's position to allow adequate exposure of the pelvis. This position leads to a small amount of movement toward the head of the bed. The table was marked at the point of the anterior superior iliac spine (ASIS) and at the point where a vertical marker touching the acromioclavicular (AC) joint of the left shoulder drops to the table. At the end of the surgery, when the operating table is leveled, the final positions of ASIS and AC will be measured. Measurements were made in centimeters to the tenth position.|About 150 minutes after start of surgery|Study size calculation was performed for 80% power, and p=0.05|||centimeters||Standard Deviation|Mean
1423575|NCT01068769|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever comes first. Progression is evaluated every 8 weeks using Response Criteria for Solid Tumors (RECIST) 1.1. Objective disease progression is defined as a 20% increase in the sum of the longest diameter of target lesion(s).|From date of enrollment until date of first documented progression or date of death from any cause, whichever came first||||months||95% Confidence Interval|Median
1423576|NCT01068769|Primary|Clinical Benefit as Defined by the Composite of Complete Response, Partial Response and Stable Disease Lasting 16 Weeks or More Per RECIST 1.1 as a Measure of Disease Control|The composite of complete response, partial response, and stable disease lasting 16 weeks or more per RECIST 1.1 as a measure of disease control. This is for target lesions. Complete response is disappearance of all target lesions and partial response is >+30% decrease in the sum of the longest diameter of target lesions. Stable disease is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions. Progressive disease is considered an increase of the sum of the longest diameter of target lesions by greater than or equal to 20%.|2 years||||percentage of participants||95% Confidence Interval|Number
1423577|NCT01068743|Secondary|Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities|Abnormalities that were considered clinically significant and/or reported as an AE by the investigator.|From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.|||participants|||Number
1423578|NCT01068743|Other Pre-specified|Metformin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||hr||Standard Deviation|Mean
1423579|NCT01068743|Other Pre-specified|Metformin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||hr||Standard Deviation|Mean
1423580|NCT01068743|Other Pre-specified|Metformin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423581|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter Tmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||hr||Standard Deviation|Mean
1423582|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter T1/2|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||hr||Standard Deviation|Mean
1423583|NCT01068743|Other Pre-specified|Saxagliptin PK Parameter AUC(0-t)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC(0-t) is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423584|NCT01068743|Secondary|Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs).|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All participants who received at least one dose of study medication.|||participants|||Number
1440902|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 6|Month 6|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1423587|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423588|NCT01068743|Primary|Metformin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1423589|NCT01068743|Primary|Metformin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423590|NCT01068743|Primary|Saxagliptin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1423591|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter Cmax|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1423592|NCT01068743|Secondary|5-hydroxy Saxagliptin PK Parameter AUC(0-inf)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423593|NCT01068743|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants not discontinuing prior to the end of the study. One participant in period 3 (treatment D) was excluded from the pharmacokinetic analysis due to a predose concentration greater than 5% of Cmax.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423594|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC[0-t] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423595|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
1423596|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
1423597|NCT01068730|Secondary|Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology|Clinically significant was determined by the investigator.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
1423598|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Terminal Half-life (T 1/2)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, T 1/2 was not analysed for 1 participant who did not have a clear terminal elimination phase.|||hr||Standard Deviation|Mean
1423599|NCT01068730|Other Pre-specified|Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.|||hr||Standard Deviation|Mean
1440903|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at Month 3|Month 3|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1423602|NCT01068730|Secondary|Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
1423603|NCT01068730|Secondary|Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening).|All treated participants not discontinuing prior to the end of the study.|||Participants|||Number
1423604|NCT01068730|Primary|Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1423605|NCT01068730|Primary|Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])|PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing|All treated participants with evaluable PK analyses. In treatment D, AUC (0-inf) was not analysed for 1 participant who did not have a clear terminal elimination phase.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1423606|NCT01068717|Primary|Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||Hours||Full Range|Median
1423607|NCT01068717|Primary|AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1423608|NCT01068717|Primary|AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1423609|NCT01068717|Primary|AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1423610|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate|Clinically significant was determined by the investigator. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes.|At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.|All enrolled participants who received study medication.|||Participants|||Number
1423611|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results|Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.|At screening visit, Day -1 of Period 1, and at study discharge|All enrolled participants who received study medication.|||Participants|||Number
1423612|NCT01068717|Secondary|Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results|Clinically significant was determined by the investigator. Hematology tests included hemoglobin, hematocrit, red blood cell count, total leukocyte count (including differential), and platelet count. Serum chemistry tests included aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, lactate dehydrogenase, creatinine, blood urea nitrogen, uric acid, fasting glucose, total protein, albumin, sodium, potassium, chloride, calcium, phosphorus, and creatine kinase. Urinalysis included protein, glucose, blood, leukocyte esterase, specific gravity, and pH.|At screening visit, at Day -1 of Periods 1 through 4, and at discharge|All enrolled participants who received study medication.|||Participants|||Number
1423613|NCT01068717|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4|All enrolled participants who received study medication.|||Participants|||Number
1423614|NCT01068717|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1423616|NCT01068717|Primary|Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1423617|NCT01068717|Primary|Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States||Days 1, 2, and 3 of Periods 1, 2, 3, and 4|All participants who received at least 1 of the 4 treatments and had sufficient plasma concentration data to facilitate the calculation of at least 1 primary pharmacokinetic parameter for at least 1 of the treatments.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1423618|NCT01068678|Secondary|Change in Body Weight|Change from baseline in body weight after week 26|Week 26|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.|||kg||Standard Deviation|Mean
1423619|NCT01068678|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after week 26|Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1423620|NCT01068665|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
1423621|NCT01068665|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data was imputed using last observation carried forward (LOCF). 2 subjects were withdrawn prior to exposure to the study drug in the IDeg arm as they were randomised in error and 1 subject in the IGlar arm.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1423622|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment|Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32)|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
1423623|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment|Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25)|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
1423624|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment|Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18)|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
1423625|NCT01068652|Secondary|Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment|Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11)|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||mg/dL||Standard Deviation|Mean
1423626|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment|Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
1423627|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment|Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}.|Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
1423628|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment|Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 19 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
1423629|NCT01068652|Secondary|Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment|Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast – Pre Breakfast), (Post Lunch – Pre Lunch) and (Post Dinner - Pre Dinner)}|Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 28 subjects, PG (mg/dL) increment values were missing at all evaluations.|||mg/dL||Standard Deviation|Mean
1423630|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32)|Week 50|Full Analysis Set (FAS) includes all randomised subjects. For 35 subjects, values were missing.|||Subjects|||Number
1423631|NCT01068652|Secondary|Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment|Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)|Week 38|Full Analysis Set (FAS) includes all randomised subjects. For 31 subjects, values were missing.|||Subjects|||Number
1423634|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) at Week 50|Observed mean change from baseline in HbA1c at Week 50 (visit 32)|Week 0, Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1423635|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 38 (visit 25)|Week 0, Week 38|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1423636|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Observed mean change in from baseline in HbA1c at Week 26 (visit 18)|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1423637|NCT01068652|Secondary|Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment|Observed mean change from baseline in HbA1c at Week 14 (visit 11)|Week 0, Week 14|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, values for change in HbA1c were missing.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1423638|NCT01068652|Primary|Glycosylated Haemoglobin (HbA1c)|Estimated mean difference in HbA1c after 50 weeks of treatment|Week 50|Full analysis set (FAS) includes all randomised subjects and missing data is imputed using last observation carried forward (LOCF). For 20 subjects, HbA1c values were missing.|||percentage of glycosylated haemoglobin||Standard Error|Mean
1423639|NCT01068626|Secondary|Change in LDL||6 months||||mmol/L||Standard Deviation|Mean
1423640|NCT01068626|Secondary|Change in Body Weight||6 months||||kg||Standard Deviation|Mean
1423641|NCT01068626|Secondary|Change in Hepatic Fat Infiltration Measured by CT.||6 months||||Hounsfield units||Standard Deviation|Mean
1423642|NCT01068626|Secondary|Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.||6 months||||ratio||Standard Deviation|Mean
1423643|NCT01068626|Secondary|Change in Subcutaneous Adipose Tissue Area||6 months||||cm2||Standard Deviation|Mean
1423644|NCT01068626|Primary|Change in Visceral Adipose Tissue Area Measured by Computed Tomography.||6 months|Per protocol|||cm2||Standard Deviation|Mean
1423645|NCT01068600|Secondary|Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study medication. If data were missing or insufficient for any one of the domains a focal score was not calculated. Missing focal scores after week 4 were imputed using last observation carried forward.|||Score on a scale||Standard Error|Least Squares Mean
1423646|NCT01068600|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.|after 12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data was imputed using last observation carried forward.|||Liters||Standard Error|Least Squares Mean
1423647|NCT01068548|Secondary|Time to Change to Oral Antibiotics||1 month|||||||
1423648|NCT01068548|Primary|Length of Hospital Stay||1 month||||Days||Standard Deviation|Mean
1423649|NCT01068509|Secondary|Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104|Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Arbitrary units||Standard Deviation|Mean
1423650|NCT01068509|Secondary|Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104|Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.|Baseline to Week 104|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Arbitrary units||Standard Deviation|Mean
1423651|NCT01068509|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 4 years 10 months)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Months||95% Confidence Interval|Median
1423672|NCT01067976|Other Pre-specified|Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
1425759|NCT01048424|Secondary|Change in Incontinence- or Bladder-specific Quality of Life|Incontinence Impact Questionnaire. Scores on the overall IIQ range from 0 to 400, with higher scores indicating greater overall impact on quality of life.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
1423652|NCT01068509|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.|Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)|Intent-to-treat population: All randomized participants. Efficacy data were not collected on the initial cohort of 7 non-randomized participants.|||Months||95% Confidence Interval|Median
1423653|NCT01068418|Secondary|The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II||baseline and 1 month following vitamin D3 therapy||||mL/min/1.72m2||Standard Deviation|Mean
1423654|NCT01068418|Primary|The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II||baseline and 1 month following vitamin D3 therapy||||mmHg||Standard Deviation|Mean
1423655|NCT01068262|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE. The study determined if the number of participants who discontinued treatment with Odanacatib 50 mg Qw for 4 consecutive weeks due to AEs was sufficiently low to permit continued clinical investigation.|Up to Week 4|All randomized participants who received ≥1 dose of study treatment|||Participants|||Number
1423656|NCT01068262|Secondary|Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE. The study determined if the number of AEs experienced by participants receiving Odanacatib 50 mg Qw for 4 consecutive weeks was sufficiently low to permit continued clinical investigation. In addition to AEs during the treatment period and post-treatment follow-up period, AEs may have occurred prior to treatment in screened participants as a result of urine and blood sampling at Baseline.|Up to Day 58|All randomized participants who received ≥1 dose of study treatment|||Participants|||Number
1423657|NCT01068262|Secondary|Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of the apparent t1/2 of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Harmonic mean, jack-knife standard deviation reported for apparent terminal t1/2.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||hr||Standard Deviation|Mean
1423658|NCT01068262|Secondary|Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Tmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||hr||Full Range|Median
1423659|NCT01068262|Secondary|Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained at 168 hours postdose on Day 22 (Week 4) to determine the similarity of steady-state C168hr (trough concentrations) of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Week 4 (168 hours postdose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||nM||95% Confidence Interval|Geometric Mean
1423660|NCT01068262|Secondary|Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Cmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||nM||95% Confidence Interval|Geometric Mean
1423661|NCT01068262|Secondary|Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4|Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state AUC0-168 hr of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Characterization of AUC0-168hr after administration of the final, Qw dose of Odanacatib 50 mg at steady state is reflective of the clinical dosing interval.|Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose)|The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol.|||µM·hr||95% Confidence Interval|Geometric Mean
1423673|NCT01067976|Other Pre-specified|Blinded Readers: Inter-reader Agreement on Categorical Accuracy Based on Assessment for UMRM vs CMRM - Breast Region Level|Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||kappa|Participants||Number
1423662|NCT01068262|Primary|Weighted Average Inhibition (WAI) of Urine Aminoterminal Crosslinked Telopeptide of Type I Collagen (u-NTx/Cr) After Administration of Odanacatib 50 mg or Placebo Qw for 4 Weeks in Healthy Males and Postmenopausal Females|uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp [mean])*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model.|Baseline to Week 4|The population of male and postmenopausal female participants on Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. The population of male participants on placebo are also included. Postmenopausal females on placebo were not analyzed for WAI due to there being too few participants in this group (N=2).|||Percent inhibition||90% Confidence Interval|Least Squares Mean
1423663|NCT01068158|Secondary|Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 2 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-Treat (Safety) population.|||Participants|||Number
1423664|NCT01068158|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Adverse events were defined and classified as follows:~'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 2 up to Day 15 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Participants|||Number
1423665|NCT01068158|Primary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat 2 (All Participants) population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
1423666|NCT01068158|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in a subset of the Intent-to-treat population (Index participants). Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
1423667|NCT01067976|Other Pre-specified|Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow–up 24 Hours Post Injection|Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||participants|||Number
1423668|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Heart Rate|Heart rate was measured in a supine position.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||beats/min||Standard Deviation|Mean
1423669|NCT01067976|Other Pre-specified|Vital Signs Change From Baseline and Follow–up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.|Baseline, Follow–up visit (24 hours post injection)|Safety Analysis Set (SAF): The analysis of safety data was performed using all available data from all participants who administered any amount of gadobutrol.|||mmHg||Standard Deviation|Mean
1423670|NCT01067976|Other Pre-specified|Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure.|||Kappa|Participants||Number
1423671|NCT01067976|Other Pre-specified|Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level|Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|Immediately before injection and after injection|All participants in the FAS with assessments for this outcome measure|||Kappa|Participants||Number
1424202|NCT01062841|Secondary|Number of All (First and Recurrent) Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only an indwelling urinary catheter present and >1 follow-up visit|||Number of CAUTI|Participants||Number
1423674|NCT01067976|Other Pre-specified|Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Majority Reader, Participant Level|The 3 blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1=not confident, 2=somewhat confident, 3=confident, and 4=very confident). The majority read value for the 3 readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers, i.e. multifocal. For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. value respectively. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|All participants in the FAS with assessments by the majority reader for both modalities in the comparison for this assessment. Majority reader results are based on the average of the 3 blinded readers’s assessment.|||difference of scores on a scale|Participants|90% Confidence Interval|Mean
1423675|NCT01067976|Other Pre-specified|Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Majority Reader, Participant Level|The disease state “bilateral malignant disease” was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region, the assessment of bilateral malignant disease was categorized as “No”. If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as “Yes”. The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease was derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on 388 participants; evaluable subjects with at least one region verified by SoT in each breast with available CMRM, UMRM, CMRM+XRM, UMRM+XRM and XRM assessment.|||difference in accuracy (%)||95% Confidence Interval|Mean
1423676|NCT01067976|Other Pre-specified|Sensitivity Difference of Detection of Multicentric Malignant Disease Verified by SoT by Majority Reader, Breast Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were based on a total number of 53 evaluable breasts with multicentric malignant disease.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1423677|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Single examination|For multifocal malignant disease, specificity analyses were based on a total number of 3816 regions, 390 participants in FAS.|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
1423678|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, specificity analyses were based on a total number of 3307 regions (i.e. regions with no disease or multifocal malignant disease), 390 participants in FAS.|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
1423693|NCT01067846|Primary|Drug Abstinence During Treatment and at Follow up Visits|Percentage of the overall number of drug abstinences of participants measured by urine drug testing|Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit|Total possible urine samples = 225 per arm. Not all participants stayed in treatment, therefore the total units analyzed will not match the total possible.|||percentage of drug abstinences|Participants||Number
1423694|NCT01067781|Secondary|Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: (1) Geometric Mean Titers (2) Geometric Mean Fold Ratios (3) Seroconversion Rates||Day 0 to Day 180|||||||
1423679|NCT01067976|Other Pre-specified|Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3240 regions, 390 participants in FAS.|||difference in specificity (%)|Participants|95% Confidence Interval|Mean
1423680|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For multifocal malignant disease, sensitivity analyses were performed for a total number of 67 regions.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1423681|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|For unifocal malignant disease, sensitivity analyses were performed for a total number of 576 regions (i.e. regions with unifocal disease verified by SoT), 390 participants in FAS.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1423682|NCT01067976|Other Pre-specified|Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 643 regions, 390 participants in FAS. Regions with malignant disease verified by SoT comprise unifocal and multifocal regions.|||difference in sensitivity (%)|Participants|95% Confidence Interval|Mean
1423683|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 1120 regions, 390 participants from FAS.|||percent difference|Participants|95% Confidence Interval|Mean
1423695|NCT01067781|Primary|Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs|Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.|Day 0 to Day 180||||participants|||Number
1423696|NCT01067768|Secondary|Catheter Days|The duration of catheterization|withdrawal of the catheter|Analysis by intention to treat|||Days||Inter-Quartile Range|Median
1423697|NCT01067768|Primary|Rate of Catheter-associated Urinary Tract Infection||Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)|Analysis by intention to treat|||infections per 1000 days||95% Confidence Interval|Number
1423684|NCT01067976|Other Pre-specified|Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level|For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.|Immediately before injection and after injection|The analyses were performed for a total number of 3883 regions, 390 participants in FAS.|||percent difference|Participants|95% Confidence Interval|Mean
1423685|NCT01067976|Other Pre-specified|Breast Level Specificity for All Breasts by Imaging Modality and by Reader|A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as (N–FP)/N, where N was total number of breasts.|Immediately before injection and after injection|The analyses were based on 390 participants; evaluable for specificity were breasts with or without malignant disease verified by SoT for which assessment by the imaging modality were available.|||specificity (%)||95% Confidence Interval|Mean
1423686|NCT01067976|Secondary|Percentage Difference of Participants Whose Additional Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Additional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 87 participants in FAS who had at least one additional cancer region according to SoT.|||difference in percentage of participants||95% Confidence Interval|Number
1423687|NCT01067976|Secondary|Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM|Index cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.|Immediately before injection and after injection|The analyses were based on 382 participants in FAS. Index cancer was defined as the cancer confirmed by histology prior to inclusion which made the participant eligible for the study.|||difference in percentage of participants||95% Confidence Interval|Number
1423688|NCT01067976|Secondary|Breast Level Specificity of CMRM Based on Malignant Breasts|A malignant breast was defined as false positive (FP), when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as true negative (TN). Specificity was then defined as TN/(TN+FP).|Immediately before injection and after injection|The analyses were based on 388 participants in FAS; evaluable for specificity were breasts with malignant disease verified by SoT for which an assessment by the imaging modality was available.|||specificity (%)||95% Confidence Interval|Mean
1423689|NCT01067976|Primary|Breast Level Specificity of CMRM for Non-malignant Breasts by Reader|A non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.|Immediately before injection and after injection|The analyses were based on 372 participants in FAS; evaluable for specificity were breasts without malignant disease as verified by Standard of Truth (SOT).|||specificity (%)||95% Confidence Interval|Mean
1423690|NCT01067976|Primary|Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).|||sensitivity %||95% Confidence Interval|Mean
1423691|NCT01067976|Primary|Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader|For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM).|Immediately before injection and after injection|The analyses were based on 388 participants in the Full Analysis Set (FAS) who had regions with malignant disease verified by Standard of Truth (SOT).|||difference in sensitivity (%)||95% Confidence Interval|Mean
1423692|NCT01067846|Primary|Treatment Retention – Number of Visits During Treatment|Number of treatment visits attended prior to discontinuation of treatment|Treatment sessions included 3 visits per week for 4 weeks|Total possible sessions attended = 180 per arm. Some participants did not complete all sessions, therefore the units analyzed will not match the total possible.|||visits|Participants|Standard Deviation|Mean
1423698|NCT01067716|Other Pre-specified|Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power||1 Year||||percentage of eyes|Participants|95% Confidence Interval|Number
1423699|NCT01067716|Other Pre-specified|Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)|After surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).|1 Year||||percentage of eyes|Participants|95% Confidence Interval|Number
1423700|NCT01067716|Other Pre-specified|Percent Manifest Refraction Spherical Equivalent Within 1.0D|Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.|1 Year|As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.|||percentage of eyes|Participants|95% Confidence Interval|Number
1423701|NCT01067716|Primary|Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||1 Year|As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.|||percentage of eyes|Participants|95% Confidence Interval|Number
1423702|NCT01067456|Secondary|Cost of Care|Cost of stay in USD|Index Hospitalization (within 48 hours)||||cost in USD||Inter-Quartile Range|Median
1423703|NCT01067456|Secondary|Direct Hospital Discharge Without Imaging|Number of patients discharged without imaging|Index Hospitalization (within 48 hours)||||Participants|||Count of Participants
1423704|NCT01067456|Primary|Length of Hospital Stay||Index Hospitalization (within 48 hours)||||Hours||Inter-Quartile Range|Median
1423705|NCT01067352|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug , SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued from the study due to AE were also recorded.|Baseline through Week 96|Safety analysis population included all randomized participants with at least 1 post-baseline assessment.|||participants|||Number
1423706|NCT01067352|Secondary|Percentage of Untreated Participants Who Showed a Spontaneous Catch-up Growth|Spontaneous catch up growth was the growth shown by SGA participants having length more than third percentile at Week 96 without any study drug treatment.|Baseline through Week 96|Data was not analyzed due to small number of evaluable participants.||||||
1423707|NCT01067352|Primary|Correlation Between Gene Expression Profiling and Catch-up Growth in Small for Gestational Age (SGA) Children|Gene expression profiling:analysis of ribonucleic acid (RNA) extracted from body tissue or fluids using Clontech Atlas Human Array to study level of activation of genes in tissue analyzed. Analysis was performed to identify possible correlation between catch-up growth (either spontaneous or drug-induced after Week 48) and therapeutic response to rhGH. Spontaneous catch up growth:shown by SGA participants having length more than third percentile at Week 96 without any treatment;drug induced growth was by SGA participants having length more than third percentile at Week 96 with drug treatment.|Baseline and Week 48|Gene expression profiling was not performed due to RNA degradation in nearly all of the blood samples and hence no comparison between gene expression and growth was made.||||||
1423708|NCT01067339|Primary|Percentage Change in Coronary Blood Flow (CBF)|The change in coronary blood flow was measured in response to maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary blood flow provides a measure of endothelium dependent microvascular function.|baseline, six months||||% change coronary blood flow||Inter-Quartile Range|Mean
1423709|NCT01067339|Primary|Percentage Change in Coronary Artery Diameter|The change of coronary artery diameter was measured in response to a maximal dose of acetylcholine administered intracoronary during an invasive coronary endothelial function assessment. Percentage change in coronary artery diameter provides a measure of endothelium dependent epicardial function.|baseline, six months||||% change coronary artery diameter||Inter-Quartile Range|Mean
1423710|NCT01067326|Primary|Reactive Hyperemia Index (RHI)|"RHI was measured by the noninvasive endothelial peripheral arterial tomography (EndoPat) test. EndoPAT results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart."|Baseline, 4 Months||||units on a scale||Inter-Quartile Range|Median
1423711|NCT01067326|Secondary|Diastolic Blood Pressure||Baseline, 4 Months||||mm Hg||Standard Deviation|Mean
1423712|NCT01067326|Secondary|Systolic Blood Pressure||Baseline, 4 Months||||mm Hg||Standard Deviation|Mean
1423713|NCT01067326|Primary|Endothelial Progenitor Cells (EPC)|Peripheral blood mononuclear cells were stained for EPC markers (cell-surface antigens CD34/CD133/KDR) and counted by flow-cytometry.|Baseline, 4 Months||||counts per 100,000 gated events||Inter-Quartile Range|Median
1423714|NCT01067144|Secondary|Time to Opioid Cessation||Up to 2 years|Intention-to-Treat Analysis Set|||days||Inter-Quartile Range|Median
1423715|NCT01067144|Primary|Time to Pain Resolution||Up to 2 years|Intention-to-Treat Analysis Set|||days||Inter-Quartile Range|Median
1423716|NCT01067105|Secondary|Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey|Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.|Weeks 6 and 12|Intent to Treat Population|||participants|||Number
1423717|NCT01067105|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population|||percentage of devices|||Number
1423718|NCT01067105|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration|Weeks 0-6 and 6-12|Intent to Treat Population|||devices|||Number
1440904|NCT00928408|Primary|Cinacalcet Dosing Frequency|Cinacalcet dosing frequency at initiation of treatment|Initiation of treatment|Full Analysis Set|||Participants|||Number
1423721|NCT01067105|Secondary|Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances|Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) * 100% and therefore reported as a percentage.|Weeks 0-12|Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses.|||percentage of correct advances||Standard Deviation|Mean
1423722|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1423723|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Months 1, 2, 3, 4, 5, and 6|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1423724|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1423725|NCT01067105|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline and Weeks 1-26|Intent to Treat Population. Subjects with missing date were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1423726|NCT01067105|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
1423727|NCT01067105|Primary|Percentage of Subjects Who Discontinue Due to AEs.||Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
1423728|NCT01067105|Primary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs)||Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
1423729|NCT01067105|Primary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 1-26|Intent to Treat Population|||percentage of participants|||Number
1423730|NCT01066923|Secondary|Hyperthermia and Hemoconcentration Identified by Retinal Imaging|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise|This measure was not collected. Equipment was not available.||||||
1423731|NCT01066923|Secondary|Activation of Coagulation|This measure was not collected. Equipment was not available.|0, 30, 60, and 90 minutes post exercise|This measure was not collected. Equipment was not available.||||||
1423732|NCT01066923|Primary|Vascular Function Measured by Peripheral Arterial Tonometry|Reactive Hyperemia Index|Baseline, 30, 60, and 90 minutes post exercise||||ratio (Reactive Hyperemia Index)||Standard Deviation|Mean
1423733|NCT01066923|Primary|Platelet Closure Time||0, 30, 60, and 90 minutes post exercise||||seconds||Inter-Quartile Range|Median
1423734|NCT01066897|Secondary|Mesolimibic Reward Activity Baseline Differences in Depression vs Healthy Controls|Because of the small number of depressed patients and noisy/unusable data, analyses were not run.|Baseline|Because of the small number of depressed patients and noisy/unusable data, analyses were not run.||||||
1423735|NCT01066897|Primary|Change in Mesolimbic Reward System Activity From Pre to Post Treatment (8 Weeks)|Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.|baseline and Week 8|Because of the limited number of depressed patients who completed the study (n=5) and noisy/unusable imaging data at various time points, this data was unable to be examined.||||||
1423736|NCT01066897|Primary|% Change in Hamilton Depression Rating Scale From Baseline to week8|"Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores equals more depression. For the change score, where higher equals greater improvement in depressive symptoms.~Healthy controls were not utilized in this analysis, as no week 8 ratings for health controls were obtained."|Baseline and weeks 8|For two drop outs, used LOCF|||percentage reduction in depression score||Standard Deviation|Mean
1423737|NCT01066897|Primary|Number of Participants Who Discontinued Study Due to Side-effects of the Medication||throughout the 8 weeks|# of participants who dropped out due to medication side-effects|||Participants|||Count of Participants
1437342|NCT00955487|Secondary|Total Ventilation Days|Of those participants who required mechanical ventilation, the total number of days receiving ventilation|After randomization up until hospital discharge||||Days||Standard Deviation|Mean
1423738|NCT01066871|Secondary|Number of Participants With Binding Antibodies (BAbs) and Neutralizing Antibodies (NAbs) to Fibroblast Growth Factor 18 (FGF18)|Number of participants with BAbs and NAbs to FGF18 at Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12 were reported.|Week 1 (pre-dose), Week 2 (pre-dose), Week 4, Months 3 and 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.|||participants|||Number
1423739|NCT01066871|Secondary|Number of Participants With Acute Inflammatory Reactions|Acute inflammatory reaction (AIR) is defined as an increase of pain by 30 millimeter (mm) on a 100 mm visual analog scale (VAS) associated with a subject-reported synovial fluid effusion within 3 days following intra-articular injection.|Baseline up to Month 12|"Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."|||participants|||Number
1423740|NCT01066871|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Local TEAEs, Systemic TEAEs, TEAEs Leading to Discontinuation and Serious Adverse Events (SAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An SAE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are those AEs that either started or worsened in severity on or after the date of first dose of study drug and on or before Month 12. Local TEAEs are those only related to the target knee. Systemic TEAEs are those that are related to other parts of the body.|Baseline up to Month 12|Safety analysis set included all participants who received at least 1 dose of trial treatment and who had at least 1 post injection safety assessment.|||participants|||Number
1423741|NCT01066871|Secondary|Number of Participants With Global Evaluation of Treatment Benefit|Participants were asked to evaluate and rate the treatment benefit as poor, fair, good, very good or excellent.|Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||participants|||Number
1423742|NCT01066871|Secondary|Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scale Scores and International Knee Documentation Committee (IKDC) Score at Months 3, 6 and 12|The KOOS is a knee-specific self-administered questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It consists of 42 items grouped into 5 sub-scales: symptoms, pain, function in daily living (FDL), function in sports and recreation activities (FSRA), and quality of life (QoL). Sub-scale scores range from 0-100, with 0 representing extreme knee problems and 100 no knee problems. The IKDC consists of 19 items to summarize symptoms such as highest level of activity without significant pain, frequency and severity of pain scales, stiffness and swelling, highest levels of activity without significant swelling or giving way, knee lock or catch, highest level of activity that can be performed on a regular basis, effect of knee on ability to perform set tasks, knee function prior to injury, and current knee function. The IKDC scores range from 0-100 where high score represents high levels of function.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||units on a scale||Standard Deviation|Mean
1423743|NCT01066871|Secondary|Number of Participants With Change From Baseline in International Cartilage Repair Society (ICRS) Grade at Months 6 and 12|The ICRS grading is used to score the amount of cartilage repair and damage. The grades range from 1 to 4 where higher grades indicate more severity of injury. Number of participants with change value of -3, -2, -1, 0, 1, and 2 from baseline in ICRS grade at Months 6 and 12 were reported. Lower change value indicates less severity of injury.|Baseline, Months 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||participants|||Number
1423744|NCT01066871|Secondary|Number of Participants With Shift From Baseline in BLOKS Sub-Scales (Cartilage 1, Synovitis, Effusion) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Total number of participants with shift from baseline in various BLOKS sub-scales (cartilage 1 [patella medial, patella lateral, femur medial trochlea, femur lateral trochlea, medial weight bearing femur, lateral weight bearing femur, tibia medial, tibia lateral], synovitis, and effusion) scores at Month 12 were reported.|Month 12|The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment.|||participants|||Number
1423745|NCT01066871|Secondary|Change From Baseline in Boston Leeds Osteoarthritis Knee Score (BLOKS) Sub-scale (Bone Marrow Lesion [BML] Size, Osteophyte Size, Meniscal Extrusion Score [MES], and Meniscal Tear Score [MTS]) Scores at Month 12|The BLOKS scoring system assesses intra-articular regions within the knee according to the following features: BML size, cartilage 1, osteophyte size, synovitis, effusion, meniscal extrusion, and meniscal tear. Change from baseline in summary scores for BML size, osteophyte size, MES, and MTS were reported. Summary scores for BML size range from 0 to 27, for osteophyte size range from 0 to 36, for MES range from 0 to 12, and for MTS range from 0 to 32, with lower scores corresponding to favorable outcomes.|Baseline, Month 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||units on a scale||Standard Deviation|Mean
1423856|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12|"Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 12|Participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator.|||Percentage of participants|||Number
1423746|NCT01066871|Secondary|Number of Participants With Response to Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Sub-scales|MOCART scoring system (comprising 9 variables) was used to describe the morphology & signal intensity of the repair tissue following MRI -degree of defect repair [DDR] score 0 (subchondral bone exposed) to 20 (complete repair); integration to the border zone [IBZ] score 0 (> 50% of length of repair tissue) to 15 (complete integration to border zone);surface of repair tissue [SRT] score 0 (>50% surface repair tissue/total degradation) to 10(surface intact);structure of repair tissue [StRT] score 0(inhomogenous/cleft formation) to 5 (homogenous);signal intensity [T2] Mapping Sequence [T2MS] and Hi-Res Sagittal Pharmacodynamic Sequence [Hi-Res SPS] score 0 (marked hyper intense for T2MS and hypo intense for Hi-Res SPS) to 15 (iso intense); subchondral lamina,subchondral bone score 0 (not impact) to 5 (intact);adhesions & effusion score 0 (yes) and 5 (no). Higher values represent more favorable outcome of repair.|Months 3 (M3), 6 (M6) and 12 (M12)|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||participants|||Number
1423747|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Thickness in the Target Knee at Months 3, 6 and 12|The change in cartilage defect thickness at Months 3, 6 and 12 based on central MRI was calculated as thickness at Months 3, 6 and 12 minus thickness at baseline, respectively.|Baseline, Months 3, 6 and 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||millimeter||Standard Deviation|Mean
1423748|NCT01066871|Secondary|Change From Baseline in Cartilage Defect Volume in the Target Knee at Months 3, 6 and 12|The change in cartilage defect volume at Months 3, 6 and 12 based on central MRI was calculated as volume at Months 3, 6 and 12 minus volume at baseline, respectively.|Baseline, Months 3, 6 and 12|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||microliter||Standard Deviation|Mean
1423749|NCT01066871|Secondary|Percent Change From Baseline in Cartilage Defect Volume and Cartilage Defect Thickness in the Target Knee at Months 3 and 6|Percent change in cartilage defect volume and cartilage defect thickness at Months 3 and 6 based on central MRI was calculated as: ([volume or thickness at Months 3 and 6 minus volume or thickness at baseline, respectively]*100)/volume or thickness at baseline.|Baseline, Months 3 and 6|"The mITT analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. n signifies the participants who were evaluable for this outcome measure for each group, respectively."|||Percent change||Standard Deviation|Mean
1423750|NCT01066871|Primary|Percent Change From Baseline in Cartilage Defect Volume at Month 12|Percent change in cartilage defect volume was calculated based on central magnetic resonance imaging (MRI): (volume at Month 12 minus volume at baseline)*100/volume at baseline.|Baseline, Month 12|"The modified intent-to-treat (mITT) analysis set included all participants from the ITT analysis set who had at least 1 post-treatment magnetic resonance imaging assessment. N (number of participants analyzed) signifies the participants who were evaluable for this outcome measure."|||Percent change||Standard Deviation|Mean
1423751|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
1423752|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per-Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected PP population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
1423759|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per-Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1437343|NCT00955487|Secondary|Need for Mechanical Ventilation|Number of participants who required endotracheal intubation and mechanical ventilation|Anytime after randomization up to 36 weeks corrected gestational age||||Participants|||Count of Participants
1423753|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. It was reported in treatment naive HCV mono-infected mTRT population receiving PEG-IFN alfa-2a and PEG-IFN alfa-2b. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. No participants were analysed for arm 'Genotype Unknown'.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
1423754|NCT01066819|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||Percentage of Participants|||Number
1423755|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|During first 12 weeks of treatment|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||participants|||Number
1423756|NCT01066819|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV ribonucleic acid (RNA) result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||participants|||Number
1423757|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423758|NCT01066819|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423795|NCT01066780|Secondary|The AzBio Sentences Will be Administered in Recorded Format in Multi-talker Babble.||2-4 weeks|||||||
1423857|NCT01065766|Primary|Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of 2hr-PPG.|||mg/dL||Standard Deviation|Mean
1423760|NCT01066819|Secondary|Percentage of Participants With at Least a 1-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423761|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|Th PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423762|NCT01066819|Secondary|Percentage of Participants With at Least a 2-log10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423763|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423764|NCT01066819|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423765|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423766|NCT01066819|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological Response (VR) was defined as HCV RNA <15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment.|At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423853|NCT01065766|Primary|Change From Baseline in 2hr-PPG at Week 24|Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of 2hr-PPG.|||mg/dL||Standard Deviation|Mean
1423767|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423768|NCT01066819|Primary|Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423769|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423770|NCT01066819|Primary|Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result <50 international units per millilitre (IU/mL) were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423771|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The per-protocol (PP) population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423772|NCT01066819|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks (Wk) after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423773|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 24 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
1440905|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at end of treatment (last dose received)|Up to Month 12|Full Analysis Set|||mg/day||95% Confidence Interval|Mean
1423774|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 24 Weeks After End of Treatment|Participants whose last test result in the follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
1423775|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Per Protocol Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their mEOT-R. Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
1423776|NCT01066793|Secondary|Percentage of Participants With Relapse After Modified End of Treatment Response by Genotype in Modified All-Treated Population at 12 Weeks After End of Treatment|Participants whose last test result in their respective follow-up time window showed mVR were considered to have maintained their modified end of treatment response (mEOT-R). Participants whose last test result in the respective follow-up time window did not show mVR, or who did not have a test result in the respective follow-up time window but whose last follow-up test result before the time window did not show mVR, were considered to have relapsed. Only participants with mEOT-R who had a HCV RNA measurement in the follow-up time window (without use of backward imputation), or whose last HCV RNA measurement at a follow-up time point before the time window did not show mVR, were included in the calculations. The number of participants with relapse was reported in treatment naive mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants|||Number
1423777|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Per-Protocol Population at Week 4 and Week 12|RVR was defined as as VR by Wk 4, mRVR was defined as mVR by Wk 4, cEVR was defined as VR by Wk 12, but no RVR, mcEVR was defined as mVR by Wk 12, but no mRVR, pEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by Wk 12, but no RVR and no cEVR, mpEVR was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||number of participants|||Number
1423778|NCT01066793|Secondary|Number of Participants With Response by Disjoint Categories in Modified All-Treated Population at Week 4 and Week 12|Rapid virological response (RVR) was defined as VR by Wk 4, Modified rapid virological response (mRVR) was defined as mVR by Wk 4, complete early virological response (cEVR) was defined as VR by Wk 12, but no RVR, modified complete early virological response (mcEVR) was defined as mVR by Wk 12, but no mRVR, partial early virological response (pEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline (including HCV RNA values <50 IU/mL) by, Wk 12, but no RVR and no cEVR, modified partial early virological response (mpEVR) was defined as at least a 2-log10 drop in HCV RNA as compared to baseline by Wk 12, but no mRVR and no mcEVR. The data is reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||number of participants|||Number
1423779|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Wk 2 and achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 2 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 2 for mSVR. Predictive values of VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423854|NCT01065766|Primary|Change From Baseline to Treatment in FPG at Week 24|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG.|Baseline and Week 24|Participants with a pre-treatment and a 24-week post-treatment measurement of FPG.|||mg/dL||Standard Deviation|Mean
1423780|NCT01066793|Secondary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Wk 2 achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive Values of VR was reported in treatment naive HCV mono-infected mTRT population participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423781|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm 10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423782|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423783|NCT01066793|Primary|Percentage of Participants With Predictive Values of Virological Response on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population|The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423784|NCT01066793|Secondary|Percentage of Participants With at Least a 1-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 1-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 1- log drop in HCV RNA was defined as drop of HCV viral load by 90%. The 1- log drop in HCV RNA was reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423785|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Per Protocol Population at Week 2, Week 4 and Week 12|Participants with 2-log drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423786|NCT01066793|Secondary|Percentage of Participants With at Least a 2-logarithm10 Drop in Hepatitis C Virus Ribonucleic Acid in Modified All Treated Population at Week 2, Week 4 and Week 12|Participants with 2-logarithm (log) drop in HCV RNA including HCV RNA values <50 IU/mL in the serum from baseline to Week 2, Week 4 and Week 12, expressed in terms of a logarithmic scale with base 10 were evaluated and reported. A 2 log drop in HCV RNA was defined as drop of HCV viral load by 99%. The 2 log drop in HCV RNA is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b.|At Week 2, Week 4 and Week 12|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423787|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Modified sustained virological response is defined as mVR of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423788|NCT01066793|Primary|Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA <50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423789|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response Over Time by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Modified virological response (mVR) is defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423790|NCT01066793|Secondary|Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Modified virological response (mVR) was defined as HCV RNA <50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423791|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 Weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423792|NCT01066793|Secondary|Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time|Virological response (VR) was defined as HCV RNA <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment|At Week 2, Week 4, Week 12, EOT, and 12 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a BL result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423793|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population|Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of <15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423794|NCT01066793|Primary|Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population|Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of <15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection [LLOD] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment.|At 24 weeks after EOT|The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result <50 IU/mL were excluded. n = the number of participants analyzed at a given time point.|||percentage of participants||95% Confidence Interval|Number
1423796|NCT01066780|Primary|Speech Perception of Standardized Sentences Presented From Recorded Format in Speech-spectrum Noise|This was a within subjects design where scores on the AzBio sentence test in speech spectrum noise were compared against quiet scores at the 2-Week and 4-Week Follow-up Visit. The AzBio corpus of sentences consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that have been equated for intelligibility. Two AzBio sentence lists were scored at each follow-up visit (2-Week and 4-Week) with either ClearVoice MEDIUM or ClearVoice HIGH enabled and averaged together. Two AzBio sentence lists were also administered in quiet at each visit. The ClearVoice score minus the quiet score provided the difference in score for the analysis.|4 Weeks||||percentage of words scored correctly||Standard Deviation|Mean
1423797|NCT01066624|Primary|Incidence of Oral Mucositis|Incidence of grade I-IV oral mucositis|First 30 days post-tranplantation||||percentage of participants|||Number
1423798|NCT01066585|Secondary|Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severe skin/scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Skin/scalp irritation was assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
1423799|NCT01066585|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Severity of the adverse events were defined and classified as follows:~'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention."|Day 1 up to Day 15 post-application.|Adverse events were assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
1423800|NCT01066585|Secondary|Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
1423801|NCT01066585|Primary|Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success defined as absence of live lice, was assessed in index participants, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.|Day 2 up to Day 15 post-application|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
1423802|NCT01066546|Secondary|Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Total possible score is sum of individual items, ranged from 5 to 15; lower score indicated a better health state."|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
1423803|NCT01066546|Secondary|Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver’s job. Overall cost of care was evaluated to quantify the resources utilized.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
1423804|NCT01066546|Secondary|Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer’s Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
1423805|NCT01066546|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
1423806|NCT01066546|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
1423807|NCT01066546|Secondary|Change From Baseline in Alzheimer’s Disease Cooperative Study–Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
1423808|NCT01066546|Secondary|Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis (0-8), visuospatial ability (0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score=greater cognitive impairment.|Baseline, Week 6, 12, 26|Data was not analyzed due to early termination of study and no participants completed the pre-defined visit schedule.||||||
1423809|NCT01066546|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 4 weeks after last dose of study treatment|Safety analysis population included all enrolled participants who received at least 1 dose of study treatment, including partial doses.|||participants|||Number
1423810|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Percentage Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in percentages."|From baseline (day 1) visit to day 7||||Percentage change in scale VAS||Inter-Quartile Range|Median
1423811|NCT01066520|Secondary|Global Judgment of Efficacy||Day 14|||||||
1423812|NCT01066520|Secondary|Time to Normal Function (Training/Sports)||Day 1 to 4, 7, 14, 42|||||||
1423813|NCT01066520|Secondary|Physician's Assessment of Normal Function/Activity (5-point-scale)||Day 1 to 4, 7, 14, 42|||||||
1423814|NCT01066520|Secondary|Swelling ('Figure-of-eight')||Day 1 to 4,7,14|||||||
1423815|NCT01066520|Secondary|FAAM Sports Subscale||Day 1 to 4, 7, 14, 42|||||||
1423816|NCT01066520|Secondary|FAAM ADL Subscale||Day 1 to 4, 14, 42|||||||
1423817|NCT01066520|Primary|Change of the Foot and Ankle Ability Measurement (FAAM), Activity of Daily Living Subscale (ADL) From Baseline to Day 7|"The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments. The Foot and Ankle Ability Measure is a 29-item questionnaire divided into two subscales: the Foot and Ankle Ability Measure, 21-item Activities of Daily Living Subscale and the Foot and Ankle Ability Measure, 8-item Sports Subscale.~Each item is scored on a 5-point Likert scale (4 to 0) from ‘no difficulty at all’ (score 4), ´slight difficulty´, ´moderate difficulty´, éxtreme difficulty´ to ‘unable to do’ (score 0). Responses marked as ´not applicable´were not counted.~Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction."|Day 1 to day 7|Changes to Baseline: absolute values. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the ‘Last Observation Carried Forward’ method.|||Scores on a scale||Inter-Quartile Range|Median
1423818|NCT01066520|Primary|Patient's Assessment of Ankle Pain (VAS)- Absolute Value Decrease on Day 7|"Pain evaluated by a 100 mm visual analogue scale (VAS) where 0 means no pain and 100 means the highest, unbearable pain. The absolute values of VAS have been the basis of analysis.~The highest is the change in negative, the better are the results in absolute values."|From baseline (day 1) visit to day 7|Changes from baseline at day7: absolute values and in percentage. Primary analyses were based on the Intent-To-Treat sample. Only patients with intial VAS<30 mm were excluded from the analysis set. Missing data were handled by the 'Last Observation Carried Forward' method.|||Absolute value units on a scale VAS||Inter-Quartile Range|Median
1423819|NCT01066156|Primary|Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.|"We will compare patients' symptomatology at baseline vs. at 8 week timepoint~Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS)~Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136~For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst~If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed"|8 weeks|It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).|||units on a scale||Standard Deviation|Mean
1423820|NCT01066143|Primary|Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.|Changes in anxiety symptomatolgy|12 week|8 subjects signed the consent but were later found to be ineligible; the study didn't start||||||
1423821|NCT01066104|Secondary|Objective (b) the Effect on Volume of Polypoid Mucosal Tissue in the Nose and Sinuses on Rhinoscopic Examination.|"Improvement is defined as any reduction in the total nasal polyp score. Using rhinoscopic evaluation, Nasal Polyp Score will be assessed on the right and on the left, and added together.~Scoring system:~Score Definition 0 No polyps~Polyp in middle meatus, not reaching below the inferior border of the middle turbinate~Polyp reaching below the inferior border of the middle turbinate but not touching the inferior turbinate~Polyp reaching below the inferior border of the middle turbinate and touching the inferior turbinate~Polyp reaching to or below the lower border of the inferior turbinate~Range: minimum 0 (better outcome), maximum 8 (worse outcome)"|4 months||||Change in Total polyp score||Standard Deviation|Mean
1437344|NCT00955487|Secondary|Severity of Bronchopulmonary Dysplasia (BPD)|Assessment of the severity of BPD as defined by the oxygen reduction test|36 weeks corrected gestational age||||Participants|||Count of Participants
1423822|NCT01066104|Primary|Objective (a) the Effect on Polypoid Mucosal Thickening in the Anterior Ethmoid and Maxillary Sinuses as Measured on Sinus CT Scan.|"Improvement is defined as any decrease in sinus CT scores at end of study.~Quantification of polypoid mucosal thickening in the anterior ethmoid and maxillary sinuses on sinus CT scan (primary outcome variable):~A sinus CT scan will be performed on Day 0 and repeated on Day 112. The CT scans will be performed with consistent orientation of the patient’s head and landmarks to assure that both the pretreatment and posttreatment scans are done with identical orientation and sections. The CT scans will be scored using the established scoring system known as the Zinreich modification of the Lund Mackay scoring system.. As an exploratory measure, a 3-dimensional scoring system developed with the radiology department of Massachusetts General Hospital may also be used."|4 months||||% Change||Standard Deviation|Mean
1423823|NCT01066039|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 6|Safety population included all participants who received at least one dose of investigational product.|||participants|||Number
1423824|NCT01066039|Secondary|Change From Baseline in Microalbumin Level at Month 6|The change in microalbumin level at Month 6 was calculated as microalbumin level at Month 6 minus microalbumin level at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||mg/dL||Standard Deviation|Mean
1423825|NCT01066039|Secondary|Change From Baseline in Albumin/Creatinine Ratio at Month 6|The change in albumin/creatinine ratio at Month 6 was calculated as albumin/creatinine ratio at Month 6 minus albumin/creatinine ratio at baseline.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||ratio||Standard Deviation|Mean
1423826|NCT01066039|Secondary|Change From Baseline in Total Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, High Density Lipoprotein (HDL) Cholesterol and Triglyceride Level at Month 6|The change in total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels at Month 6 was calculated as total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at Month 6 minus total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels at baseline, respectively.|Baseline, Month 6|"FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and n signifies those participants who were evaluable for the specified category."|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1423827|NCT01066039|Secondary|Change From Baseline in C-Peptide Level at Months 3 and 6|The change in C-peptide level at Months 3 and 6 was calculated as C-peptide level at Months 3 and 6 minus C-peptide level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1423828|NCT01066039|Secondary|Change From Baseline in Insulin Level at Months 3 and 6|The change in insulin level at Months 3 and 6 was calculated as insulin level at Months 3 and 6 minus insulin level at baseline.|Baseline, Months 3 and 6|FAS included all participants who took the investigational product at least once and for whom the primary efficacy endpoint (HbA1c) was measured.|||mcIU/mL||Standard Deviation|Mean
1423829|NCT01066039|Secondary|Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Months 3 and 6|HOMA-IR is as an indicator of insulin resistance in participants with Type 2 diabetes mellitus and comorbid hypertension. HOMA-IR was derived from fasting plasma glucose (FPG) and fasting insulin (FI) using the formula: (FI [micro international units per milliliter {mcIU/mL}] * FPG [millimole per liter {mmol/L}]) divided by 22.5. The change in HOMA-IR at Months 3 and 6 was calculated as HOMA-IR at Months 3 and 6 minus HOMA-IR at baseline.|Baseline, Months 3 and 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||mcIU/mL * mmol/L||Standard Deviation|Mean
1423830|NCT01066039|Secondary|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Blood Pressure (BP) at Month 6|The change in SBP, DBP, and mean BP at Month 6 were calculated as SBP, DBP, and mean BP at Month 6 minus SBP, DBP, and mean BP at baseline, respectively. Mean BP was calculated using the formula: (DBP plus [{SBP minus DBP} divided by 3]).|Baseline, Month 6|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||mmHg||Standard Deviation|Mean
1423831|NCT01066039|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 3|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 3 was calculated as HbA1c at Month 3 minus HbA1c at baseline.|Baseline, Month 3|FAS included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||Percent HbA1c||Standard Deviation|Mean
1423832|NCT01066039|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 6|HbA1c represents the percentage of glycosylated hemoglobin. The change in HbA1c at Month 6 was calculated as HbA1c at Month 6 minus HbA1c at baseline.|Baseline, Month 6|Full analysis set (FAS) included all participants who received at least one dose of investigational product and for whom the primary efficacy endpoint (HbA1c) was measured.|||Percent HbA1c||Standard Deviation|Mean
1423855|NCT01065766|Primary|Change From Baseline to Treatment in HbA1c at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C.|Baseline and Week 24|All participants with a pre-treatment and a 24-week post-treatment HbA1c value.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
1423833|NCT01066000|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8– 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.|||Participants|||Number
1423834|NCT01066000|Secondary|Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods|Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.|Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20|ITT population was defined as all participants who entered into study and took at least one dose of study drug. The ITT and safety population were identical. Data of maximum number of participants (24 participants) available at the time of analysis were analysed and 9 participants discontinued the study before this analysis.|||μg/month||Standard Deviation|Mean
1423835|NCT01066000|Secondary|Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods|Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Months||Standard Deviation|Mean
1423836|NCT01066000|Secondary|Mean Time Spent by Participants in the Haemoglobin Range of 10 – 12 g/dL During the Efficacy Evaluation Period|Mean time spent in the haemoglobin range 10 – 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Weeks||Standard Deviation|Mean
1423837|NCT01066000|Secondary|Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period|The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Percentage of participants|||Number
1423838|NCT01066000|Secondary|Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period|The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.|Up to Week 24|ITT population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||g/dL||Standard Deviation|Mean
1423839|NCT01066000|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.|Up to Week 28|Safety population included all participants who entered into the study and took at least one dose of study drug.The ITT and safety population were identical. Data of maximum number of participants (33 participants) available at the time of analysis were analysed and reported.|||Participants|||Number
1423840|NCT01066000|Primary|Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)|The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.|Up to Week 24|Intent to treat (ITT) population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.|||Percentage of participants|||Number
1423841|NCT01065844|Secondary|Quality of Life|Quality of life as measured by the EORTC QLQ-C30 survey|every 1 to 3 months|||||||
1423842|NCT01065844|Primary|Tumor Progression|Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).|Every 1 to 3 months|Those with adverse events necessitating interruption of intervention and removal from study were not assessed for outcome measures|||Participants|||Count of Participants
1423843|NCT01065818|Primary|Optimal Timepoint During the Course of Neoadjuvant Therapy [CRT, CT (Chemotherapy) or RT Radiotherapy)] That FLT-PET Imaging Can Predict Response||2.5 months|Due to poor enrollment, data was not analyzed. Adequate data was not collected and the only type of data that remained available was the total # enrolled, some information of the population demographics, and AE/SAE logs that were submitted to the IRB for review.||||||
1423844|NCT01065779|Primary|Change From Baseline in Alkaline Phosphatase at End of Treatment|For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||mg/dL||Standard Deviation|Mean
1423845|NCT01065779|Primary|Change From Baseline in Urine Deoxypyridinoline at End of Treatment|For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||nmol/mmol||Standard Deviation|Mean
1423846|NCT01065779|Primary|Change From Baseline in Serum Osteocalcin at End of Treatment|For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||ng/mL||Standard Deviation|Mean
1423847|NCT01065779|Primary|Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment|For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.|Baseline and End of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation. Only participants with lab values submitted to Sponsor were included.|||ng/mL||Standard Deviation|Mean
1423848|NCT01065779|Primary|Number of Participants With Improved, Unchanged, or Worsened Disease|"Evaluation of disease improvement was conducted in 3 categories of improved, unchanged, or worsened. Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either improved, unchanged, or worsened."|Baseline and end of Treatment (Up to ~ 16 weeks)|Among 798 participants in safety evaluation, there was a total of 789 participants for efficacy evaluation excluding 8 participants who took study drug for < 4 weeks and 1 participant who did not enter efficacy evaluation.|||Participants|||Number
1423849|NCT01065779|Primary|Number of Participants With Non-Serious AEs|An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.|||Participants|||Number
1423850|NCT01065779|Primary|Number of Participants With Unexpected Adverse Events|Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE.|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.|||Participants|||Number
1423851|NCT01065779|Primary|Number of Participants With Serious Adverse Events|"Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.~SAEs were considered serious if the event resulted in:~death or was life-threatening~prolonged an existing inpatient hospitalization~a persistent or significant disability/ incapacity~a congenital anomaly/ birth defect~a significant medical situation, other important medical event based upon appropriate medical judgment of the investigator"|Up to ~ 16 weeks and 14 days after treatment discontinuation|Safety evaluation was performed in participants who took at least one dose of study medication and completed > 1 follow up visit.|||Participants|||Number
1423852|NCT01065766|Primary|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24|"Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: Improved, Stable and Worse in a Medical History/Physical Examination form."|At Week 24|Participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator.|||Percentage of participants|||Number
1423858|NCT01065766|Primary|Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG.|Baseline and Week 12|Participants with a pre-treatment and a 12-week post-treatment measurement of FPG.|||mg/dL||Standard Deviation|Mean
1423859|NCT01065766|Primary|Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12|HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C.|Baseline and Week 12|All participants with a pre-treatment and a 12-week post-treatment HbA1c value.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
1423860|NCT01065766|Primary|Percentage of Participants With Any Adverse Experience|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 26 weeks|All participants who were included in the safety evaluation|||Percentage of participants|||Number
1423861|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Hydrogel Vehicle on Targeted Area of One Half of Body.|Five timed readings at (0, 15, 30, 45 and 60 minutes) were taken, using the Corneometer 825 meter, on participants using Hydrogel vehicle|Baseline to 14 days|per protocol|||percentage of participants||Standard Deviation|Mean
1423862|NCT01065714|Secondary|Percentage of Participants With an Increase in Skin Hydration Using Eucerin Lotion on Targeted Area on One Half of Body|Five timed readings ( 0, 15, 30, 45 and 60 minutes) were taken using the Corneometer 825 meter on subjects using Eucerin lotion on targeted area on one half of body|Baseline to 14 days|per protocol|||Percentage of participants||Standard Deviation|Mean
1423863|NCT01065714|Primary|Percent Change of Trans Epidural Water Loss (TEWL) With the Use of Hydrogel Vehicle|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on target areas of body half treated with Hydrogel vehicle|Day 1 to Day 14|Per protocol|||percent change||Full Range|Median
1423864|NCT01065714|Primary|Percent Change of Trans Epidermal Water Loss (TEWL) With Use of Eucerin Lotion|The average of three sequential Tewameter 300 meter readings taken at a minimum of one minute intervals on targeted area of body half treated with Eucerin lotion|Day 1 to Day 14|per protocol|||percent change||Full Range|Median
1423865|NCT01065597|Secondary|Change in Brain-derived Neurotrophic Factor (BDNF) Blood Level|Change in plasma level of BDNF in pg/ml pre and post NET treatment course.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 subjects had a seizure during the first treatment and therefore had no seizure-free (nonconvulsive) data, and 2 subjects declined blood draw|||pg/ml||Full Range|Median
1423866|NCT01065597|Secondary|Change in Score on the Autobiographical Memory Inventory Short Form (AMI-S)|The Autobiographical Memory Inventory Short Form (AMI-S ) assesses effects on retrograde memory for autobiographical information including information related to a family member, recent travel, events of last New Year's eve, events of last birthday, employment information, and events of last non-psychiatric illness and its treatment. Subjects responded to specific questions regarding these topics before and after their course of NET treatment. Subjects were scored based on the percent of responses post-NET treatment that correctly matched their responses prior to NET treatment. The score range is 0 to 100%. The higher the percent, the less impaired is the autobiographical memory.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data|||% correct responses||Standard Deviation|Mean
1423867|NCT01065597|Secondary|Change in Score on Mini-mental State Exam|Score range is 0 to 30 points. The higher the score, the better the cognition. So a higher score means less cognitive impairment.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data|||units on a scale||Standard Deviation|Mean
1423868|NCT01065597|Primary|Change in Score on the 17-item Hamilton Depression Rating Scale|Score range is 0 to 54 points. The higher the score, the more depressed symptoms.|Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments|2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data|||units on a scale||Standard Deviation|Mean
1423869|NCT01065558|Secondary|Decrease in Self-injurious Behavior at End of Study (Two Weeks After Screening) Compared to Screening|Change in the self-injurious subscale of the Behavior Problems Inventory (BPI). the BPI is a well-validate test to evaluate the frequency and severity of a patient's self-injurious behavior. Values range from 0 to 50, and a low score means few/less severe behaviors|Screening visit and end of study (two weeks)|All patients who received any dose of ecopipam were in the analysis population|||Change in BPI score||Standard Deviation|Mean
1423870|NCT01065558|Primary|Number of Participants With Clinically Significant Changes in Standard Laboratory Tests|This study’s primary outcome is the safety of ecopipam in Lesch-Nyhan patients as measured by standard clinical laboratory tests. The patients will also be observed and questioned about other side effects, such as whether they feel more or less tired.Standard clinical laboratory tests for liver, kidney and blood function were conducted. The normal ranges for each of these tests were different and are too numerous to be individually listed here. However, if any individual value were to be either three-times greater or lesser than the upper or the lower limit of the test, then that value was considered to have been changed.|Two weeks|All patients were analyzed|||Participants|||Number
1423871|NCT01065506|Primary|Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day|Point Prevalence Abstinence (PPA) was defined as not smoking [even a single puff] at the end of treatment and/or on the day of follow-up|End of treatment (10 weeks post quit day) and 30-week follow-up|Participants who completed the end of treatment assessment|||number of participants|||Number
1423872|NCT01065480|Primary|Number of Participants With MI Skillfulness|MI skillfulness measured by the Motivational Interviewing Treatment Integrity Scale (MITI) on double coded audio recorded sessions and clinical interviews.|1,8,16, 24 and 32 weeks||||Participants|||Count of Participants
1423873|NCT01065454|Secondary|Osteopontin - Change From Baseline to Week 16|Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||µg/mL||Standard Deviation|Mean
1423874|NCT01065454|Secondary|Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16|Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||µmol/L||Standard Deviation|Mean
1423875|NCT01065454|Secondary|Troponin T - Change From Baseline to Week 16|Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||µg/L||Standard Deviation|Mean
1423876|NCT01065454|Secondary|N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-pro BNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||pg/mL||Standard Deviation|Mean
1423877|NCT01065454|Secondary|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||ng/mL||Standard Deviation|Mean
1423878|NCT01065454|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16|The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The MLHF total score can range from 0 (best) to 105 (worst).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
1423879|NCT01065454|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
1423880|NCT01065454|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Scores on a scale||Standard Deviation|Mean
1423881|NCT01065454|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all cause mortality, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function.|At visit 6 (16 weeks)|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis.|||Percentage of participants|||Number
1423882|NCT01065454|Secondary|WHO (World Health Organization) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement, changes to a higher functional class resemble deterioration of PAH.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Percentage of participants|||Number
1423883|NCT01065454|Secondary|6-minute Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||m||Standard Deviation|Mean
1440906|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 12|Month 12|Full Analysis Set - Participants with Observed Data|||mg/day||95% Confidence Interval|Mean
1423884|NCT01065454|Secondary|Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16|E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||E/A ratio||Standard Deviation|Mean
1423885|NCT01065454|Secondary|E-wave Deceleration Time - Change From Baseline to Week 16|E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||msec||Standard Deviation|Mean
1423886|NCT01065454|Secondary|Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16|Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mL||Standard Deviation|Mean
1423887|NCT01065454|Secondary|Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16|Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mL||Standard Deviation|Mean
1423888|NCT01065454|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Percentage||Standard Deviation|Mean
1423889|NCT01065454|Secondary|Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16|Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
1423890|NCT01065454|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mm||Standard Deviation|Mean
1423891|NCT01065454|Secondary|Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16|Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
1423892|NCT01065454|Secondary|Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16|The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
1423893|NCT01065454|Secondary|Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16|The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80*(SAPmean - RAPmean)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
1423894|NCT01065454|Secondary|Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16|The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80*(SAPmean - RAPmean)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5||Standard Deviation|Mean
1424203|NCT01062841|Primary|Total Number of Ciprofloxacin-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of Ciprofloxacin-RGNB|||Number
1423895|NCT01065454|Secondary|Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16|The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80*(PAPmean - PCWP)*BSA/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5*m^2||Standard Deviation|Mean
1423896|NCT01065454|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||dyn*s*cm^-5||Standard Deviation|Mean
1423897|NCT01065454|Secondary|Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16|The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||Percentage||Standard Deviation|Mean
1423898|NCT01065454|Primary|Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and visit 6 (16 weeks)|Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF [safety analysis set]/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.|||mmHg||Standard Deviation|Mean
1423899|NCT01065428|Secondary|Neuromechanical Efficiency (NME)|NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).|at 30 minutes of the spontaneous breathing trials (SBT)||||cmH2O/uV||Standard Deviation|Mean
1423900|NCT01065428|Primary|Neuroventilatory Efficiency (NVE)|NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.|at 30 minutes of the spontaneous breathing trials (SBT)||||ml/uV||Standard Deviation|Mean
1423901|NCT01065350|Secondary|Average Change in Stroke Volume Variation (SVV)|SVV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. SVV is a dynamic flow-based parameter and together with cardiac output provides an indication of fluid responsiveness. The average change in SVV (as compared to baseline SVV) during the specified time intervals is reported. SVV is calculated by taking the SVmax – SVmin /*100/ SV mean.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 38/35 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Percentage of mean stroke volume||Standard Deviation|Mean
1423902|NCT01065350|Secondary|Average Change in Stroke Volume Index (SVI)|SVI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SVI (as compared to baseline SVI) during the specified time intervals is reported. To determine SVI, stroke volume is divided by the body surface area in order to account for body size.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Milliters per beat per m^2 of body area||Standard Deviation|Mean
1423903|NCT01065350|Secondary|Average Change in Stroke Volume (SV)|SV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SV from baseline during the specified time intervals is reported. SV is the milliliters of blood ejected during each contraction of the heart.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Milliliters of blood per beat||Standard Deviation|Mean
1423904|NCT01065350|Secondary|Average Change in Total Peripheral Resistance Index (TPRI)|TPRI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPRI from baseline during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/39 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||dynes * sec/cm^-5/m^2||Standard Deviation|Mean
1423905|NCT01065350|Secondary|Average Change in Total Peripheral Resistance (TPR)|TPR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPR from baseline during the specified time intervals is reported. TPR is the overall resistance to blood flow through the systemic blood vessels.|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 39/38 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||dynes * sec/cm^-5||Standard Deviation|Mean
1423916|NCT01065051|Secondary|Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests|The slope of the relationship between work rate during cardiopulmonary exercise tests and PAPmean is derived from the directly measured hemodynamic parameter mean pulmonary arterial pressure (PAPmean). PAPmean is acquired during a right heart catheterization.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423906|NCT01065350|Secondary|Average Change in Mean Arterial Pressure (MAP)|"MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in MAP from baseline during the specified time intervals is reported.~MAP is a term used in medicine to describe an average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 43/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1423907|NCT01065350|Secondary|Average Change in Diastolic Blood Pressure (DBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in DBP (as compared to baseline DBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction||||mmHg||Standard Deviation|Mean
1423908|NCT01065350|Secondary|Average Change in Systolic Blood Pressure (SBP)|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SBP (as compared to baseline SBP) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction||||mmHg||Standard Deviation|Mean
1423909|NCT01065350|Secondary|Average Change in Heart Rate (HR)|HR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in HR (as compared to baseline HR) during the specified time intervals is reported.|Baseline, 5 minutes, 10 minutes post induction||||Beats per minute||Standard Deviation|Mean
1423910|NCT01065350|Secondary|Average Change in Cardiac Index (CI)|"CI was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CI as compared to the baseline CI during the specified time intervals is reported.~To determine CI, cardiac output is divided by the body surface area in order to account for body size."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Liters per minute per m^2 of body area||Standard Deviation|Mean
1423911|NCT01065350|Secondary|Average Change in Cardiac Output (CO)|"CO was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CO as compared to baseline CO during the specified time intervals is reported.~CO is defined as the quantity of blood ejected per minute by the heart into the systemic circulation. It is the product of the heart rate (HR) (beats per minute) times the stroke volume (SV) (milliliters of blood ejected during each contraction)."|Baseline, 5 minutes, 10 minutes post induction|The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.|||Liters per minute||Standard Deviation|Mean
1423912|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia|MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in MAP of greater than 20% during the specified time intervals is reported, as compared to the baseline MAP reading.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.|||Percentage of subjects|||Number
1423913|NCT01065350|Secondary|Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in DBP of greater than 20% during the specified time intervals is reported, as compared to the baseline DBP reading. The second or lower number of a blood pressure reading is the DBP and is the measure taken when your heart is at rest.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.|||Percentage of subjects|||Number
1423914|NCT01065350|Primary|Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia|Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.|Baseline, 5 minutes, 10 minutes, 30 minutes post induction|85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.|||Percentage of subjects|||Number
1423915|NCT01065051|Secondary|Change in the Ventilatory Efficiency (V’E/V’CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)|Ventilatory efficiency (V’E/V’CO2) and anaerobic threshold (AT) were parameters directly measured or derived by computed analysis from the spiroergometry system during the cardiopulmonary exercise test.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423917|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E’) During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak early diastolic velocity (E’) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423918|NCT01065051|Secondary|Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests|The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423919|NCT01065051|Secondary|Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests|The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423920|NCT01065051|Secondary|Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests|The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423921|NCT01065051|Secondary|Change in Peak Power Index During the Cardiopulmonary Exercise Tests|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. Formula: Peak Power Index = (SAPmean - PCWPmean)*CO*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423922|NCT01065051|Secondary|Change in End-systolic Elastance at Rest|The end-systolic elastance is a calculated hemodynamic parameter. It is approximated by the directly measured hemodynamic parameter end-systolic pressure divided by the directly measured echocardiography parameter left ventricular end-systolic volume (LVESV). The end-systolic pressure is acquired during a right heart catheterization. The LVESV is acquired during a non-invasive echocardiography examination. Approximated by end-systolic pressure/LVESV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423923|NCT01065051|Secondary|Change in Left Ventricular Ejection Fraction (LVEF) at Rest|The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423924|NCT01065051|Secondary|Change in Left Ventricular Stroke Work Index (LVSWI) at Rest|The left ventricular stroke work index (LVSWI) is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The LVSWI is also dependent of the calculated hemodynamic parameter stroke volume index (SVI). Formula: LVSWI = (SAPmean – PCWPmean)*SVI*0.0136|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423925|NCT01065051|Primary|Change in Peak Power Index at Rest|The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)*CO [cardiac output]*16.667/LVEDV|Before and 1 hour after administration of study drug|Due to the very low number of patients enrolled in the study, no statistical evaluation was done.||||||
1423926|NCT01064947|Secondary|Local Tolerability|"The investigator assessed the following characteristics on a grading scale of 0-3 (none, mild moderate or severe): erythema, inflammation, infection, crusting, necrosis, peeling, swelling and contact dermatitis.~The subject assessed the following characteristics on a scale of 0-3 (none, mild, moderate or severe): irritation, itchiness burning, tenderness and pain."|Day 7||||units on a scale||Inter-Quartile Range|Median
1423927|NCT01064947|Secondary|Investigator Assessment of Clinical Cure|The investigator assessed clinical cure at Day 7 as either total or improved cure, failure confirmed or failure by default|Day 7||||participants|||Number
1423928|NCT01064947|Secondary|Skin Infection Rating Scale (SIRS)|The Primary Investigator rated the each of the following characteristics: exudate/pus, crusting, erythema/inflammation, tissue warmth, tissue edema, itching and pain on a scale of 0-6 (absent-severe) to create an overall SIRS score ranging from 0-42.|Day 1 and Day 7||||units on a scale||Inter-Quartile Range|Median
1423929|NCT01064947|Primary|Bacteriological Culture|All participants were cultured for S.aureus (MRSA), S.aureus (MSSA) and S. pyogenes at Baseline. If positive at Baseline then they were cultured again at Day 7.|Day 1 and Day 7||||participants|||Number
1423930|NCT01064882|Secondary|Treatment Satisfaction Questionnaire Score at Month 3|The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).|Month 3|Modified Intent-to-Treat: All randomized subjects who were treated with the intended study medication and completed at least one follow-up visit.(Note: 2 subjects in the Bim 0.015% treatment group, 1 subject in the Bim 0.005% treatment group, and 1 subject in the Bim 0.03% treatment group did not have Month 3 visit data for this outcome measure)|||Scores on a Scale||Standard Deviation|Mean
1423931|NCT01064882|Secondary|Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3|Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.|||Scores on a Scale||Standard Deviation|Mean
1423932|NCT01064882|Secondary|Change From Baseline in Overall Eyelash Satisfaction at Month 3|"Change from baseline at Month 3 in question 3 overall, how satisfied are you with your eyelashes? Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline."|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.|||Scores on a Scale||Standard Deviation|Mean
1423933|NCT01064882|Secondary|Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3|Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.|Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit.|||Percentage of Subjects|||Number
1423934|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3|Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)|||Units on a Scale||Standard Deviation|Mean
1423935|NCT01064882|Secondary|Change From Baseline in Upper Eyelash Thickness at Month 3|Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)|||Millimeters squared (mm^2)||Standard Deviation|Mean
1423936|NCT01064882|Primary|Change From Baseline in Eyelash Length at Month 3|Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 3|Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one-follow-up visit. (Note that one subject in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)|||millimeters (mm)||Standard Deviation|Mean
1423937|NCT01064856|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12|The ASDAS is a continuous disease activity score: low score indicates lower disease activity and higher values indicate higher disease activity. The score ranges from 0 to no defined upper limit. It is categorized into 4 disease activity states based on score: inactive disease (< 1.3), moderate (≥ 1.3 to < 2.1), high (≥ 2.1 to ≤ 3.5), and very high (> 3.5). Clinically important and major improvements in ASDAS are defined as a reduction from Baseline of ≥ 1.1 and ≥ 2.0 points, respectively. Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and with non-missing values for both Baseline and post-baseline visit.|||units on a scale||Standard Deviation|Mean
1423938|NCT01064856|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|Seventy-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 76 (worst possible score/76 joints with swelling). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423939|NCT01064856|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|Seventy-eight joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 78 (worst possible score/78 joints with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423940|NCT01064856|Secondary|Change From Baseline in Dactylitis at Week 12|Assessment of the presence or absence of dactylitis as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranging from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values for both Baseline and the post-baseline.|||units on a scale||Standard Deviation|Mean
1423941|NCT01064856|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score at Week 12|Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was quantified on a dichotomous basis. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (worst possible score; 16 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423942|NCT01064856|Secondary|Change From Baseline in Leeds Enthesitis Index at Week 12|Assessment of enthesitis was performed in the following 6 domains: left and right lateral epicondyle, left and right medial femoral condyle, left and right Achilles tendon insertion. Tenderness at each site was quantified on a dichotomous basis: Each domain was graded for the presence (1) and absence (0) of tenderness yielding total Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423943|NCT01064856|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Participants with non-missing Baseline and at least 1 non-missing post-Baseline value were included in post-Baseline visits. LOCF: missing value was imputed using the last non-missing post-Baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423944|NCT01064856|Secondary|Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12|The Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) is a 36-item generic health-related quality of life measure to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug and had non-missing values.|||units on a scale||Standard Deviation|Mean
1423945|NCT01064856|Secondary|Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12|The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423946|NCT01064856|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12|The BASDAI was to be completed at the designated study visits. The participant was to assess his/her disease activity using the BASDAI which consisted of a VAS scale used to answer 6 questions (Q1 through Q6) pertaining to symptoms experienced by the participant for the past week. Each question on the BASDAI was reported in centimeters (0 [none] to 10 [very severe] with one question's possible answers being in time increments [0 hours to ≥ 2 hours]). The overall BASDAI score ranges from 0 to 10 cm and was calculated as follows: BASDAI Score = 0.2 × (Q1 + Q2 + Q3 + Q4 + Q5/2 + Q6/2). Lower scores indicate less disease activity. LOCF: Missing value was imputed using the last non-missing post-baseline value prior to missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423947|NCT01064856|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12|A VAS was to be used for the Physician Global Assessment (PGA) of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. Last observation carried forward (LOCF): missing values were imputed using the last non-missing post-baseline value prior to the missing value.|Baseline (last measurement prior to first DB dose), Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug.|||units on a scale||Standard Deviation|Mean
1423948|NCT01064856|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|Baseline (day of first study drug administration) through Week 156 plus 70 days|Safety Analyses included all participants who received at least 1 dose of double-blind study drug.|||participants|||Number
1423949|NCT01064856|Primary|Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12|Percentage of participants achieving the following composite response at Week 12: >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; >= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA – Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and >= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.|Week 12|Efficacy analyses included all participants who were randomized and received at least 1 dose of double-blind study drug (ITT).|||percentage of participants|||Number
1423950|NCT01064830|Secondary|Patients Assessment of Satisfaction With Length of Fingernails|"the percentages of participants who were satisfied with the length of fingernails"|20 weeks|all patients enrolled who completed this response measure at week 20.|||percentage of patients|||Number
1423951|NCT01064830|Primary|• Number of Patients Receiving at Least a 1-grade Improvement in the Physicians Global Improvement Assessment (PGIA) of Two Target Nails.|IN a scale of 0-3 where 0 means normal nail and 3 means severe disease, the number of patients who received at least a decrease of 1 grade in the evaluation of two target nails|20 weeks||||patients|||Number
1423952|NCT01064817|Primary|Subjects With Safety Related Events or Findings|The number of Subjects with AEs, TEAEs, SAEs, decreased visual acuity, and worsened visual fields|First injection through end of study for AEs, SAEs, visual acuity and visual fields, and from first injection through Day 30 for TEAEs||||participants|||Number
1423953|NCT01064817|Other Pre-specified|Bleb Scarring|Exploratory Efficacy Outcome measure: Bleb scarring is graded on a scale from 0-3. 0= none to minimal scarring, 1= mild, 2= moderate, 3= severe scarring.|Day 120|Number of subjects who had assessment of bleb scarring on Day 120|||units on a scale||Standard Deviation|Mean
1423954|NCT01064817|Other Pre-specified|Successful Intra-ocular Pressure (IOP) Control|Exploratory efficacy outcome measure. Successful IOP control defined as IOP between 6 and 18 mm Hg or 25% reduction from pre-surgical IOP|Day 120||||participants|||Number
1423955|NCT01064817|Primary|Safety of Subconjunctival Injection|Number of adverse events (AEs), treatment emergent adverse events (TEAEs), non-ocular TEAEs, Ocular TEAEs, serious adverse events (SAEs), abnormal slit-lamp biomicroscopic findings, and abnormal dilated fundoscopy findings|AEs, slit-lamp, and fundoscopy findings from first injection through end of study; TEAEs from first injection through Day 30|All subjects enrolled in study; all subjects received all study treatment|||Number of occurrences|||Number
1423956|NCT01064739|Secondary|Urinary Sodium|urinary sodium 8-12 hours after breakfast|8-12 hours after breakfast||||mEq/4hr||Standard Deviation|Mean
1423957|NCT01064739|Secondary|Urinary Sodium|Urinary sodium excreted 0-4 hours after breakfast.|0-4 hours after breakfast||||mEq/4hr||Standard Deviation|Mean
1423958|NCT01064739|Secondary|Supine Heart Rate|Supine heart rate 6 hours after breakfast|6 hours after breakfast||||beats per minute||Standard Deviation|Mean
1423959|NCT01064739|Secondary|Supine Systolic Blood Pressure|Supine systolic blood pressure 6 hours after breakfast|Supine-6 hours after breakfast on both study days.||||mm Hg||Standard Deviation|Mean
1423960|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 8-12 hours after breakfast|8 to 12 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
1423961|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 4-8 hours after breakfast|4 to 8 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
1423962|NCT01064739|Secondary|Urinary Norepinephrine|Urinary norepinephrine excreted 0-4 hours after breakfast|0 to 4 hours after breakfast||||micrograms/4 hours||Standard Deviation|Mean
1423963|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 8 to 12 hours after breakfast|8 to 12 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
1423964|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 4 to 8 hours after breakfast|4 to 8 hours after breakfast||||micrograms/4 hours||Standard Deviation|Mean
1423965|NCT01064739|Secondary|Urinary Dopamine|Urinary dopamine excreted 0 to 4 hours after breakfast|0 to 4 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
1423966|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|8-12 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
1423967|NCT01064739|Secondary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|0-4 hours after breakfast||||ug/4hr||Standard Deviation|Mean
1423976|NCT01064739|Secondary|Plasma Dopa 6 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 6 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1423977|NCT01064739|Primary|Urinary Sodium|Urinary sodium excreted 4-8 hours after breakfast was designated as a primary outcome. Other urine samples (0-4 hr, 8-12 hr after breakfast) are considered as non-primary outcomes.|4 to 8 hours after breakfast||||mEq/4 hr||Standard Deviation|Mean
1423978|NCT01064739|Primary|Urinary Dopa|Urinary dopa excreted 4-8 hours after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (0-4 hr, 8-12 hr after breakfast) are non-primary outcomes.|4-8 hours after breakfast||||micrograms/4hr||Standard Deviation|Mean
1423979|NCT01064739|Secondary|Plasma Dopa 4 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 4 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1423980|NCT01064739|Secondary|Plasma Dopa 2 Hrs After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 2 hours after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1423981|NCT01064739|Primary|Plasma Dopa 1 hr After Breakfast|Subjects consumed the standard fixed sodium diet for at least two days prior to study and on study day one during an inpatient stay in the Vanderbilt Clinical Research Center. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr). Blood was sampled for catechol assays before and at 1, 2, 4 and 6 hours after breakfast. Plasma dopa 1 hour after breakfast was specified as a primary outcome. Other catechols (dihydroxyphenylglycol, norepinephrine, epinephrine, dopamine, dihydroxyphenylacetic acid) and other time points (2, 3, 4, 6hr after breakfast) are non-primary outcomes.|Plasma samples collected 1 hour after breakfast on both study days.||||pg/mL||Standard Deviation|Mean
1423982|NCT01064713|Primary|Number of Participants With Response|Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.|Day 84||||participants|||Number
1423983|NCT01064713|Primary|Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response)|Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.|Day 84||||percentage of participants|||Number
1423984|NCT01064687|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) for LY2189265|Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 13 weeks, 26 weeks, and 52 weeks|Participants who were randomized at baseline to LY2189265 and received at least 1 dose of study drug with evaluable AUC data.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
1423985|NCT01064687|Secondary|Change From Baseline to 26 Weeks in N Terminal Pro Brain Natriuretic Peptide (NT-proBNP)||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable NT-proBNP data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
1423986|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Hematological and Biochemical Lab Values||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.|||||Standard Error|Least Squares Mean
1423987|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Hematological and Biochemical Lab Values||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||||Standard Error|Least Squares Mean
1437723|NCT00951912|Primary|Percentage Change in Triglyceride|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
1423988|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only TEAEs that occurred during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.|||participants|||Number
1423989|NCT01064687|Secondary|Number of Participants With Treatment Emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||participants|||Number
1423990|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 52 Weeks and 4 Weeks After Last Dose of Study Drug|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|26 weeks through 52 weeks and 53 weeks through 4 weeks after last dose|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.|||participants|||Number
1423991|NCT01064687|Secondary|Number of Participants With LY2189265 Antibodies at 26 Weeks|LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed. The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA were summarized.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable LY2189265 ADA data. In the clinically evaluated dose range of LY2189265, no dose effect on the magnitude of the anti-LY2189265 immune response was observed. Therefore, results were combined for the 0.75 mg and 1.5 mg LY2189265 groups.|||participants|||Number
1423992|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 52 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.|||participants|||Number
1423993|NCT01064687|Secondary|Number of Participants Requiring Rescue Therapy Due to Hyperglycemia at 26 Weeks|"Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period. Time to start first new glucose-lowering intervention due to hyperglycemia (rescue therapy) was analyzed between the groups using the semi-parametric proportional hazard regression model with treatment group and country as fixed effects and baseline glycosylated hemoglobin (HbA1c) as a covariate."|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||participants|||Number
1423994|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
1423995|NCT01064687|Secondary|Rate of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of equal to or less than 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of equal to or less than 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo. Only pre-rescue measurements were used.|||events per participant per year||Standard Deviation|Mean
1423996|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 52 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug.|||events|||Number
1423997|NCT01064687|Secondary|Number of Self-reported Hypoglycemic Events at 26 Weeks|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||events|||Number
1423998|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Serum Calcitonin||Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1423999|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Serum Calcitonin||Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable serum calcitonin data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1424000|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter||Inter-Quartile Range|Median
1424001|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable pancreatic enzyme data. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units per liter||Inter-Quartile Range|Median
1424002|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 52 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks, with the exception of the Placebo/1.5 mg LY2189265 and Placebo/0.75 mg LY2189265 treatment groups, which include only participants with confirmed pancreatitis during treatment with LY2189265 (26 weeks through 52 weeks). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265, Exenatide, or Placebo and received at least 1 dose of study drug.|||participants|||Number
1424003|NCT01064687|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo.|||participants|||Number
1424004|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Mean
1424005|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least one dose of LY2189265, Exenatide, or Placebo with evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1424006|NCT01064687|Secondary|Change in Baseline to 52 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1424007|NCT01064687|Secondary|Change in Baseline to 26 Weeks on Pulse Rate|Seated pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable seated pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1424008|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable ECG QTcF Interval or PR Interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
1424009|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable ECG QTcF Interval or PR interval data.|||milliseconds (msec)||Standard Error|Least Squares Mean
1424010|NCT01064687|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks|Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event since the previous inquiry. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug. The number of participants with adjudicated CV events was not collected at 26 weeks.|||participants|||Number
1424011|NCT01064687|Secondary|Change From Baseline to 52 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable IW-SP data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1424012|NCT01064687|Secondary|Change From Baseline to 26 Weeks on the Impact of Weight on Self-Perception|The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable IW-SP data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1424013|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable APPADL data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1427152|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Deviation|Mean
1424014|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Impact of Weight on Activities of Daily Living|"The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = not at all difficult and 1 = unable to do. The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate."|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable APPADL data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1424015|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc) Versions|The Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change (DTSQc) versions are used to assess participant treatment satisfaction at each study visit and relative change in satisfaction from baseline, respectively. Both questionnaires consist of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The change version has the same 8 items as the status version with a small alteration of the wording of Item 7. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied) for the DTSQs and from -18 (much less satisfied) to +18 (much more satisfied) for the DTSQc. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable DTSQs or DTSQc data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1424016|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Version|The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1, and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). The DTSQ change version (DTSQc) was not collected at 26 weeks. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline score as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable DTSQs data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) used to impute missing postbaseline values. If there were no data after randomization, endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1424017|NCT01064687|Secondary|Change From Baseline to 52 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable EQ-5D data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1424018|NCT01064687|Secondary|Change From Baseline to 26 Weeks in the EuroQol 5|The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable EQ-5D data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Error|Least Squares Mean
1424028|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
1438343|NCT00947531|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry, Urinalysis ), ECG (Electrocardiogram)||Baseline, week 4, 12, 16, 24||2009-09-30|09/2009||||
1424019|NCT01064687|Secondary|Change From Baseline to 52 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
1424020|NCT01064687|Secondary|Change From Baseline to 26 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)|The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HOMA2-%B or HOMA2-%S data. Only pre-rescue measurements were used.|||percentage of HOMA2||Standard Error|Least Squares Mean
1424021|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 52 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1424022|NCT01064687|Secondary|Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1424023|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable SMPG data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1424024|NCT01064687|Secondary|Change From Baseline to 26 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles|The SMPG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least squares (LS) means of the mean of the 8 time points (daily mean) were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable SMPG data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1424025|NCT01064687|Secondary|Change From Baseline to 52 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable BMI data. Only pre-rescue measurements were used.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
1424026|NCT01064687|Secondary|Change From Baseline to 26 Weeks on Body Mass Index (BMI)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable BMI data. Only pre-rescue measurements were used.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
1424027|NCT01064687|Secondary|Change From Baseline to 52 Weeks for Body Weight|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit as fixed effects and baseline as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
1424061|NCT01064323|Primary|Brachial Diameter|mm|baseline||||mm||Standard Deviation|Mean
1424029|NCT01064687|Secondary|Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|Participants who were randomized at baseline to LY2189265 or Exenatide and received at least 1 dose of study drug with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1424030|NCT01064687|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265, Exenatide, or Placebo with evaluable HbA1c data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1424031|NCT01064622|Secondary|Activity (Overall Response Rate) in Crossover Patients|RECIST response rate in patients after crossover from placebo to vismodegib arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
1424032|NCT01064622|Secondary|Incidence of Adverse Events|Details are provided in Adverse Events section below. Reported here are percentage of patients in each arm with any grade 1 or higher adverse event, regardless of attribution.|Up to 3 years||||percentage of participants||95% Confidence Interval|Number
1424033|NCT01064622|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months|Phase I lead-in patients were not included in the efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
1424034|NCT01064622|Secondary|Overall Survival|Time from randomization to death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.|||months||95% Confidence Interval|Median
1424035|NCT01064622|Primary|Progression-free Survival|Time from randomization to disease progression or death from any cause. Estimated in the two treatment groups by the Kaplan-Meier method and compared using a stratified logrank test.|Up to 3 years|Phase I lead-in patients were not included in the efficacy analysis.|||months||95% Confidence Interval|Median
1424036|NCT01064414|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
1424037|NCT01064414|Secondary|Percentage of Patients With HbA1c <7% at Week 26|The table below shows the percentage of patients with HbA1c <7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1424038|NCT01064414|Primary|Change in HbA1c From Baseline to Week 26|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 26|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 26 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1424039|NCT01064401|Secondary|Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks|The MSIS-29 is a 29-item disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient’s perspective; it measures physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of ≥ 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.|Baseline and 96 weeks|participants with a baseline and Week 96 assessment|||percentage of participants|||Number
1424040|NCT01064401|Secondary|Proportion of Participants Relapse-free at Week 144|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.|144 weeks||||proportion of participants|||Number
1424062|NCT01064323|Primary|Brachial Flow Velocity|Measured using ultrasound, units cm/sec.|50 minutes into IPC||||cm/sec||Standard Deviation|Mean
1424041|NCT01064401|Secondary|Proportion of Participants With Sustained Disability Progression at 144 Weeks|Sustained disability progression is defined as: at least a 1.0-point increase on the EDSS from Baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.|Baseline through 144 weeks||||proportion of participants|||Number
1424042|NCT01064401|Secondary|Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96|The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.|up to 96 weeks|participants with baseline and at least one post-baseline MRI measurement|||lesions||95% Confidence Interval|Mean
1424043|NCT01064401|Primary|Adjusted Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.|Up to 144 weeks|participants with a relapse|||relapses per person-years|Participants|95% Confidence Interval|Number
1424044|NCT01064362|Secondary|Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.|||participants|||Number
1424045|NCT01064362|Primary|Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)|Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands.|Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first|From the PHARMO RLS, all patients >=18 years of age with in-hospital pharmacy data, a primary discharge diagnosis for hip fracture and/or a hospitalization for MOSLL, and follow-up between January 2003 (introduction of Arixtra) and December 2008.|||participants|||Number
1424046|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|1 hour after IPC||||nM||Standard Deviation|Mean
1424047|NCT01064323|Primary|Plasma S-nitrosothiols|nM|baseline||||nM||Standard Deviation|Mean
1424048|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|1 hour after IPC|Data was not collected for 1 participant for this outcome measure.|||nM||Standard Deviation|Mean
1424049|NCT01064323|Primary|Red Blood Cell Nitric Oxide|nM|baseline|Data was not collected for 1 participant for this outcome measure.|||nM||Standard Deviation|Mean
1424050|NCT01064323|Primary|Plasma Nitrite|nM|1 hour after IPC||||nM||Standard Deviation|Mean
1424051|NCT01064323|Primary|Plasma Nitrite|nM|baseline||||nM||Standard Deviation|Mean
1424052|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, %|1 hour after IPC|Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.|||percentage of constriction||Standard Deviation|Mean
1424053|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, %|baseline|Data for this outcome measure was only available for 8 out of 10 participants due to reduced image quality.|||percentage of constriction||Standard Deviation|Mean
1424054|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, mm|1 hour after IPC||||mm||Standard Deviation|Mean
1424055|NCT01064323|Primary|Brachial Occlusion-mediated Constriction|Brachial Occlusion-mediated constriction measured via ultrasound, mm|baseline||||mm||Standard Deviation|Mean
1424056|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, %|1 hour after IPC||||percentage of dilation||Standard Deviation|Mean
1424057|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, %|baseline||||percentage of dilation||Standard Deviation|Mean
1424058|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, mm|1 hour after IPC||||mm||Standard Deviation|Mean
1424059|NCT01064323|Primary|Brachial Flow Dilation|Brachial Flow Mediated dilation, mm|baseline||||mm||Standard Deviation|Mean
1424060|NCT01064323|Primary|Brachial Diameter|mm|1 hour after leg IPC||||mm||Standard Deviation|Mean
1424065|NCT01064310|Secondary|Change From Baseline (BL) in Heart Rate|Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.|||Beats per minute||Standard Deviation|Mean
1424066|NCT01064310|Secondary|Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)|When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.|Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)|Safety-Randomized Study Population. All participants who received sunitinib or pazopanib either during Period 1 or Period 2 were counted in both treatment groups (sunitinib and pazopanib). Only those participants contributing data at the indicated time points were evaluated.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1424067|NCT01064310|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants with adverse events leading to permanent discontinuation of study treatment were evaluated.|||participants|||Number
1424068|NCT01064310|Secondary|Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Baseline to end of study (maximum of 22 weeks)|Safety-Randomized Study Population|||participants|||Number
1424069|NCT01064310|Secondary|Number of Participants With the Indicated Reason for Receiving a Dose Reduction|Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|"Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated. Participants may be counted multiple times for the same reason for a dose reduction if the participant had multiple reductions for the same reason."|||participants|||Number
1424070|NCT01064310|Secondary|Number of Participants With the Indicated Number of Dose Reductions|Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.|||participants|||Number
1424071|NCT01064310|Secondary|Time to Dose Modification|For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.|End of second treatment period (maximum of 22 weeks)|Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.|||weeks||95% Confidence Interval|Median
1424072|NCT01064310|Secondary|Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores|The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])|Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.|||Scores on a scale||Standard Deviation|Mean
1424080|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.|||infants|||Number
1424204|NCT01062841|Primary|Total Number of Ceftazidime-resistant GNB (Gram-negative Bacilli) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of Ceftazidime-RGNB isolate|||Number
1424073|NCT01064310|Secondary|Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score|Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.|Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])|Safety-Randomized Study Population: participants who received at least one dose of either drug regardless of treatment period. Participants who received mixed treatment within a period were excluded. Only those participants contributing data at the indicated time points were evaluated.|||Scores on a scale||Standard Deviation|Mean
1424074|NCT01064310|Primary|"Number of Participants Answering Yes, no, or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire"|The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|mITT Population. Responses to some categories of the PPQ may be missing for some participants.|||participants|||Number
1424075|NCT01064310|Primary|Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)|The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.|End of treatment of both study drugs (maximum of 22 weeks)|Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.|||participants|||Number
1424076|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.|||infants|||Number
1424077|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received|The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy with valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.|||infants|||Number
1424078|NCT01064297|Primary|Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received|The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.|||infants|||Number
1424079|NCT01064297|Primary|Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Among lamotrigine polytherapy without valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.|||infants|||Number
1424096|NCT01064076|Primary|Percentage of Participants Free of Type I Complications at 180 Days.|Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.|180 days|The analysis cohort includes all subjects undergoing an implant attempt.|||percentage of participants||95% Confidence Interval|Number
1424081|NCT01064297|Primary|Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.|||infants|||Number
1424082|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate|The number of live births, fetal deaths with pregnancy loss occurring >=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to the lamotrigine polytherapy without valproate|||infants|||Number
1424083|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate.|||infants|||Number
1424084|NCT01064297|Primary|Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy|The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.|Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy.|||infants|||Number
1424085|NCT01064284|Secondary|To Evaluate the Incidence of All Other Adverse Events Related and Not Related to the Products Used||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed||||||
1424086|NCT01064284|Secondary|To Evaluate Laboratory Factors Potentially Associated to Inhibitor Development||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed||||||
1424087|NCT01064284|Secondary|To Evaluate Clinical Factors Potentially Associated to Inhibitor Development||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed||||||
1424088|NCT01064284|Secondary|To Evaluate the Modality of Occurrence of Inhibitors (Titre at Onset)|Inhibitor Titre at Onset|During 6 months of observation, from the inhibitor occurrence||||Bethesda Units||Full Range|Median
1424089|NCT01064284|Secondary|To Evaluate the Modality of Occurrence of Inhibitors (Number of EDs)|Number of EDs: Number of Exposure Days (EDs) after which the inhibitors develop|During the first 50 exposure days or first 3 years of enrollment, whichever occurs first||||Exposure days||Full Range|Median
1424090|NCT01064284|Secondary|To Evaluate the Frequency of Transient Inhibitors|Number of participants for each group who developed transient inhibitors (this means, those inhibitors which disappeared spontaneously within 6 months without immunotolerance treatment).|In the 6 months after inhibitor development|Data at 6‑month follow‑up were missing for two patients assigned to plasma‑ derived factor VIII and three patients assigned to recombinant factor VIII.|||participants|||Number
1424091|NCT01064284|Secondary|To Evaluate the Anamnestic Response of Inhibitor Patients||During the first 50 exposure days or first 3 years of enrollment, whichever occurs first|Data were not collected and the Outcome will never be analyzed.||||||
1424092|NCT01064284|Primary|To Assess the Immunogenicity of Plasma Derived VWF/FVIII and rFVIII Concentrates by Determining the Frequency of Inhibitor Development in the First 50 EDs or in the First 3 Years From Enrolment, Whichever Comes First in PUPs and MBCTs|"Expressed with the numebr of patients for each group who developed FVIII inhibitors.~PUPs: Previously Untreated Patients MBCTPs: Minimally Blood Component-Treated Patients"|During the first 50 exposure days or first 3 years of enrollment, whichever occurs first||||participants||95% Confidence Interval|Number
1424093|NCT01064167|Secondary|Postoperative Chest Tube Drainage||24h postoperative||||ml||Standard Deviation|Mean
1424094|NCT01064167|Primary|Number of Patients Required Allogenic Red Blood Cells Transfusion||1month postoperative|As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery.|||participants|||Number
1424095|NCT01064076|Primary|Percentage of Participants Who Pass Induced VF Conversion Test|Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.|Implant/Pre-Discharge|304 subjects had a complete VF conversion test recorded|||percentage of participants||95% Confidence Interval|Number
1424205|NCT01062841|Primary|Total Number of VRE (Vancomycin Resistant Enterococci) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of VRE isolates|||Number
1424097|NCT01063907|Secondary|Phase 1: PK Elimination t½ hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.|||hr||Standard Deviation|Mean
1424098|NCT01063907|Secondary|Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.|||hr*ng/mL||Standard Deviation|Mean
1424099|NCT01063907|Secondary|Phase 1: PK Exposure Cmax ng/mL Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11 in Phase 1 only.|||ng/mL||Standard Deviation|Mean
1424100|NCT01063907|Secondary|Phase 1: PK Absorption Tmax hr Day 11|Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day.|PK collected Day 11 of 21-day cycle|The PK of KW-2478 was characterized after single administrations through @25 hours post start of infusion dose on Day 1 and through @7 hours post start of infusion dose on Day 11in Phase 1 only.|||hr||Standard Deviation|Mean
1424101|NCT01063907|Primary|To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).|"The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.~The ORR, was defined as the best response over a specified number of cycles (calculated and summarized).~Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized)."|21 day cycle, up to 52 weeks|All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.|||participants|||Number
1424102|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT])"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of < 1 minute and patients with an IELT of > 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424103|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Disease Type)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424104|NCT01063881|Secondary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Dosage)"|"The Clinical Global Impression of Change (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which “subgroup by dosage” was categorized based on dose-titration patterns observed during the course of the treatment period."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424105|NCT01063881|Secondary|Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424106|NCT01063881|Secondary|The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to the speed of ejaculation. Patient's were asked: Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely? The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424107|NCT01063881|Secondary|The Patient's Level of Personal Distress Related to the Speed of Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation. Patient's were asked: Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely. The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424108|NCT01063881|Secondary|The Patient's Level of Satisfaction With Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale. Patients were asked: Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424109|NCT01063881|Secondary|The Patient's Level of Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good?” The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below."|Baseline and Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424110|NCT01063881|Primary|"The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment"|"The Clinical Global Impression of Change (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?” The number of patients who described improvement with their PE of at least slightly better after 12 weeks of treatment with dapoxetine are provided in the table below."|Week 12|The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy.|||Patients|||Number
1424111|NCT01063868|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.|Entire Study|Safety analysis set (All randomized participants who took at least one dose of study medication).|||participants|||Number
1424112|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Slightly Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better”. The percentage of patients who reported improvement in PE of at least slightly better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
1424113|NCT01063855|Secondary|The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 1-category decrease (improvement) in interpersonal difficulty related to ejaculation is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
1424114|NCT01063855|Secondary|"The Percentage of Patients Reporting At Least a Better Response to Treatment"|"The Clinical Global Impression of Change (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better”. The percentage of patients who reported improvement in PE of at least better at Endpoint (after 12 weeks of treatment) is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
1424115|NCT01063855|Secondary|The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater increase in satisfaction with sexual intercourse is provided in the table below."|Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
1424147|NCT01063517|Secondary|Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population|Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having global score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424116|NCT01063855|Secondary|The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation and control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported a composite score of at least a 2-category increase in control over ejaculation and at least a 1-category decrease (improvement) in personal distress is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
1424117|NCT01063855|Secondary|The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who achieved 1-category or greater decrease (improvement) in personal distress related to the speed of ejaculation is provided in the table below."|At Endpoint (After 12 weeks of treatment)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
1424118|NCT01063855|Secondary|The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation|"The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's control over ejaculation on a 5-point scale from Very poor, Poor, Fair, Good, to Very Good. The percentage of patients who reported at least a 2-category increase in control over ejaculation is provided in the table below."|At the end of treatment (Week 12)|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||Percentage of Patients|||Number
1424119|NCT01063855|Primary|The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12|The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction.|Baseline, Week 12|The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method.|||minutes||Standard Deviation|Mean
1424120|NCT01063829|Secondary|Number of Patients With Systemic Detectable HCMV Replication.||84 days||||Participants|||Count of Participants
1424121|NCT01063829|Primary|Time to Onset of “HCMV Prophylaxis Failure”||84 days||||days|||Number
1424122|NCT01063829|Primary|Number of Participants With “HCMV Prophylaxis Failure”||84 days||||Participants|||Count of Participants
1424123|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted)|"The outcome was also calculated for each 3-month Period but here only the result for the total Second Evaluation Period (Second Period without following 6-weeks Withdrawal Period for withdrawers) is presented.~Change in partial seizure frequency from Baseline (B) over Second Evaluation Period (E) is given as a percentage reduction computed as:~(B values- E values) / B values x 100. Positive values in percent reduction show a decrease from Baseline. Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7."|From Baseline (Week 0-8) until the time of approval granted (up to three years from date of informed consent (Week 0); without 6-weeks Withdrawal Period)|Full Analysis Set (FAS).|||Percent reduction||Inter-Quartile Range|Median
1424124|NCT01063764|Secondary|Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Drug Reaction (ADR) is an Adverse Event for which a causal relationship between the product and the occurrence is suspected. Incidence of ADRs is reported by the number of subjects with at least one ADR.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).|||participants|||Number
1424125|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 10-weeks Evaluation Period|"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.|||participants|||Number
1424126|NCT01063764|Secondary|Number of Seizure-free Subjects Over the 14-weeks Treatment Period|"Seizure-free means not having a seizure of type I (Partial seizure).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).|||participants|||Number
1424127|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Evaluation Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data over the Evaluation Period.|||percentage of participants||95% Confidence Interval|Number
1424148|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.|||Percent change||Standard Deviation|Mean
1424128|NCT01063764|Secondary|Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period|"50 % responders are those subjects which have a 50 % or more reduction in the frequency of partial seizures from Baseline to the Treatment Period. The results show the percentage of participants that are 50 % responders.~Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS).|||percentage of participants||95% Confidence Interval|Number
1424129|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period|"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Evaluation Period/number of days for observation in the Evaluation Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.|||Seizures per week||Inter-Quartile Range|Median
1424130|NCT01063764|Secondary|Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The seizure frequency per week was calculated as:~Frequency per week of partial seizures = (Total number of partial seizures in the Treatment Period/number of days for observation in the Treatment Period) x 7. Partial seizures can be classified into one of the following three groups:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22))|Full Analysis Set (FAS). Only subjects having values unequal to zero over Baseline and values equal to or greater than zero over Treatment Period are included.|||Seizures per week||Inter-Quartile Range|Median
1424131|NCT01063764|Secondary|Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period|"The change in partial seizure frequency from Baseline (B) over the Evaluation Period (E) is given as a percentage reduction computed as:~(B values- E values) / B values x 100. Positive values in percent reduction mean that the value decreased from Baseline to the 10-week Evaluation Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 10-weeks Evaluation Period (Part of the first Period: Week 12 to Week 22)|Of the 73 subjects in the FAS, 68 subjects had available data at Baseline and during the Evaluation Period.|||Percent reduction||95% Confidence Interval|Median
1424132|NCT01063764|Primary|Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted)|An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Incidence of treatment-emergent AEs is reported by the percentage of subjects with at least one treatment-emergent AE.|During the second Period from Visit 8 (Week 22) to the end of the Follow-up Period (up to three years until the time of approval granted)|Full Analysis Set (FAS).|||percentage of participants|||Number
1424133|NCT01063764|Primary|Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period|"The change in partial seizure frequency from Baseline (B) over the Treatment Period (T) is given as a percentage reduction computed as:~(B values- T values) / B values x 100.~Positive values in percent reduction mean that the value decreased from Baseline during the first 14-week Period.~Frequency per week of partial seizures = (Total number of partial seizures in a certain Period/number of observation days in the Period) x 7.~Partial seizures can be classified into:~Simple partial seizures~Complex partial seizures~Partial seizures evolving to secondarily generalized seizures."|From Baseline (Week 0-8) to the 14-weeks Treatment Period (First Period: 4 weeks Up-titration (Week 8-12) and 10 weeks Evaluation (Week 12-22)); Week 0-22|Full Analysis Set (FAS).|||Percent reduction||95% Confidence Interval|Median
1424134|NCT01063712|Secondary|Number of Patients With a Decreased Dilation of the Left Heart Chamber (Time Frame: One Year After Treatment). Dilation of the Left Ventricle and Left Atrium Was Measured Before and One Year After Implantation by Echocardiography.|The patients were examined clinically and echocardiographically after 24 hours, one month, three months and six months after the percutaneous closure. Dilation of the left ventricle and left atrium are consequences of the hyperflow through the ducts. Regression of both ventricle and atrium are expected after closure of the ducts and can be documented by echocardiography. Additionally, the position of the device and the doppler flow in the descending aorta and left pulmonary artery were documented.|one year after percutaneous closure|"The patient selection was based in the consecutive case and intention to treat method. All patients recruited in the determinated time frame (June 2009 to May 2010) who met the initial inclusion criteria were treated in the catheterisation laboratory. There the definite inclusion criteria were applied."|||participants|||Number
1424135|NCT01063712|Primary|Number of Patients With a Closed Patent Ductus Arteriosus (Defect) Determinated by Echocardiography ( Time Frame: One Year After Treatment)|The closure rate is an effectiveness outcome. Complete closure without a residual shunt is defined as absence of color flow (an echocardiographic technique used to observe the flow of blood in the heart) between the aorta and the pulmonary artery through the duct. Additionally, the position of the device, regression of the dilation of the left ventricle and left atrium and assessing of unrestricted doppler flow in the descending aorta and left pulmonary artery were documented. Clinical status was also assessed.|up to one year after percutaneous closure|"29 patients were controled in a period of one year and were examinated by echocardiography.The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."|||Participants|||Number
1424149|NCT01063517|Secondary|Percentage Change in Tumour Size at Week 8 in the Overall Study Population|Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)|Tumour scans done at Baseline and week 8|Evaluable for response population - randomised patients having measurable disease at baseline.|||Percent change||Standard Deviation|Mean
1438344|NCT00947531|Primary|CIBIC+ (Clinicians Interview-based Impression of Change) Score at Week 24||week 24||2009-09-30|09/2009||||
1424136|NCT01063595|Secondary|Concentration of Plasmin Inhibitor|Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.|From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.|||Percentage inhibition||Standard Deviation|Mean
1424137|NCT01063595|Primary|Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C|Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.|||Percentage change||Standard Deviation|Mean
1424138|NCT01063595|Primary|Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI|Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.|From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration|Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.|||Percentage change||Standard Deviation|Mean
1424139|NCT01063517|Secondary|Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424140|NCT01063517|Secondary|Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424141|NCT01063517|Secondary|Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424142|NCT01063517|Secondary|Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424143|NCT01063517|Secondary|Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424144|NCT01063517|Secondary|Time to Deterioration in QoL Pain Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having pain domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424145|NCT01063517|Secondary|Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population|Time calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424146|NCT01063517|Secondary|Time to Deterioration in QoL Fatigue Score in the Overall Study Population|Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data|Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months|Randomised patients having fatigue score calculated at baseline and at least one post baseline visit|||months||Inter-Quartile Range|Median
1424198|NCT01062841|Secondary|Total Number of Residents With New VRE (Vancomycin Resistant Enterococci) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with > 1 follow-up visit, and who were at-risk to acquire a new VRE colonization (not colonized at baseline)|||Number of Residents with New VRE|Participants||Number
1424150|NCT01063517|Secondary|Objective Response Rate (ORR) in the ATM Negative Patients|Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.|||Participants|||Number
1424151|NCT01063517|Secondary|Objective Response Rate (ORR) in the Overall Study Population|Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).|Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months|Evaluable for response population - randomised patients having measurable disease at baseline.|||Participants|||Number
1424152|NCT01063517|Secondary|Overall Survival (OS) in ATM Negative Patients|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients|||months||Inter-Quartile Range|Median
1424153|NCT01063517|Secondary|Overall Survival (OS) in the Overall Study Population|Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.|Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months|Full analysis set including all randomised patients|||months||Inter-Quartile Range|Median
1424154|NCT01063517|Primary|Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including randomised ATM negative patients|||months||Inter-Quartile Range|Median
1424155|NCT01063517|Primary|Progression Free Survival (PFS) in the Overall Study Population|PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.|Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months|Full analysis set including all randomised patients|||months||Inter-Quartile Range|Median
1424156|NCT01063348|Secondary|Skin Picking Self Assessment Scale (SP-SAS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score."|Once every three weeks for the duration of the 12 week study for each subject||||units on a scale||Standard Deviation|Mean
1424157|NCT01063348|Primary|Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)|"The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed.~The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported."|Once every three weeks during the 12 week study for each subject||||units on a scale||Standard Deviation|Mean
1424158|NCT01063153|Primary|Percent Errors in Visual Go/NoGo Task|The Go/NoGo visual task was completed by subjects with ADHD as well as healthy controls. The Go/NoGo task is used to assess inhibitory control, and targets response inhibition, executive functions, and sustained attention. The 'Go' stimulus occupies 80% of the trials, and requires the subject to perform a motor response each time it appears on the screen. A rare 'No Go' stimulus (occupies 20% of all trials) requires the subject to refrain from responding. The percentage of errors were measured for each group.|Single Point (Baseline)|Only subjects that met the a priori pre-defined EEG signal quality criteria were included.|||percentage of errors|||Number
1424159|NCT01063153|Primary|Adult ADHD Investigator Symptom Rating Scale (AISRS)|An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta.|Baseline and 6 weeks|Subjects in the ADHD group who completed all 6 weeks of the trial were included in data analysis. Subjects who completed at least 3 weeks of treatment were also included regardless of the reason for withdrawal, and final-visit AISRS scores were used in ITT (intent-to-treat) analysis via last observation carried forward [LOCF] imputation.|||units on a scale||Standard Deviation|Mean
1424160|NCT01063075|Primary|Cetuximab PK: Confirmatory Serum Concentration||Group D: Prior to Carboplatin Infusion, Cycle 1, Day 1|All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data. Study design by intent did not collect data from Groups A, B, and C.|||micrograms per milliliters (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1424161|NCT01063075|Primary|Cetuximab PK: Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.|||Hour (h)||Full Range|Median
1424162|NCT01063075|Primary|Total Carboplatin PK: Time of Maximum Observed Plasma Concentration (Tmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.|||Hour (h)||Full Range|Median
1424163|NCT01063075|Primary|Cetuximab PK: Maximum Observed Plasma Concentration at Steady State (Cmax,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1424164|NCT01063075|Primary|Total Carboplatin PK: Maximum Observed Plasma Concentration (Cmax)||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.|||micrograms per milliliters (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1424165|NCT01063075|Primary|Cetuximab PK: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss)||(Group B: Cycle 1 and Cycle 2+ ; Day 1, 8, 15 and Group C: Cycle 1, Day 8, 15 and 22; Cycle 2+, Day 1,8 and 15): Prior to Cetuximab Infusion, 1 Hour (H), 2 H, 4 H, 8 H, 24 H, 72 H, 120 H, and 168 H (after the start of Cetuximab Infusion)|All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Groups D and A.|||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
1424166|NCT01063075|Primary|Total Carboplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞])||Group D: Cycle 1, Week 1, Day 1; Prior to Carboplatin Infusion, 1hour (H), 1:30 H, 2 H, 3 H, 5 H, 8 H, 24 H, 72 H (after the Start of Carboplatin Infusion)|Participants who received at least 1 dose of study drug who were enrolled in Group(Grp)D & had evaluable PK data.Study design by intent did not collect data from Grp B.Due to participant recruitment & retention challenges,there were no PK study completers for Grp A & C.Participant recruitment & retention addressed by amending protocol to add Grp D.|||micrograms*hour/milliliters (μg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
1424167|NCT01063062|Secondary|Number of Participants With Elevated Triglyceride According to ATPIII Guidelines|Blood samples were collected for Triglyceride and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Triglyceride level in milligram/deciliter (mg/dL) was categorized as: Normal (< 150), Borderline High (150- 199), High (200- 499) or Very High (≥ 500). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
1424168|NCT01063062|Secondary|Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for Low Density Lipoprotein (LDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the LDL Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Optimal (< 100), Near Optimal/Above Optimal (100- 129), Borderline High (130- 159), High (160-189) or Very High (≥ 190). The number of participants categorized Borderline High, High or Very High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
1424169|NCT01063062|Secondary|Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines|Blood samples were collected for High Density Lipoprotein (HDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the HDL Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Low (< 40) or High (≥ 60). The number of participants with category High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
1424170|NCT01063062|Secondary|Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines|Blood samples were collected for Total Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Desirable ( < 200), Borderline High (200- 239) or High (≥ 240). The number of participants categorized Borderline High or High at each time-point is reported.|Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
1424171|NCT01063062|Secondary|Number of Participants With Elevated AST (SGOT) and ALT (SGPT)|Blood was collected for aspartate aminotransferase (serum glutamic oxaloacetic transaminase) [AST/SGOT] and alanine aminotransferase (serum glutamic pyruvic transaminase) [ALT/SGPT], liver function tests, and were analyzed at a central laboratory. The number of participants with High AST (SGOT) or ALT (SGPT) levels at Week 24 is reported.|Week 24|Participants from the safety population, all participants who received study drug and had at least 1 post-dose safety assessment, with data available for analysis.|||participants|||Number
1424172|NCT01063062|Secondary|Number of Participants With Serious Infections|A serious infection was an infection that qualified as a Serious Adverse Event (SAE). A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
1424173|NCT01063062|Secondary|Number of Participants With AE and SAE Related Discontinuation|The number of participants who stopped using the study drug because of an AE or a SAE. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
1424174|NCT01063062|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|24 Weeks|Safety population included all participants who received study drug and had post-dose safety data available.|||participants|||Number
1424175|NCT01063062|Secondary|Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR), a test to assess inflammation, at Weeks 4, 8, 12, 16, 20, 24 and was analyzed at a central laboratory. ESR was measured in millimeters/hour (mm/hr).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time point. Last observation carried forward.|||mm/hr||Standard Deviation|Mean
1424176|NCT01063062|Secondary|C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP), a test for inflammation, at Weeks 4, 8, 12, 16, 20 and 24 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL).|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had data for at least one follow-up variable, with data available for the given timepoint.|||mg/L||Standard Deviation|Mean
1424177|NCT01063062|Secondary|Disease Activity Score 28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Weeks 4, 8, 12, 16, 20, 24|Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time-point. Last observation carried forward.|||score on a scale||Standard Deviation|Mean
1424178|NCT01063062|Secondary|Time to DAS28 Remission|Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||days||95% Confidence Interval|Mean
1424179|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Remission|DAS28 Remission was defined as a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||percentage of participants|||Number
1424180|NCT01063062|Secondary|Time to DAS28 Clinically Significant Improvement|Time to DAS28 Clinically Significant Improvement was the Time in days from the first infusion of study drug to the achievement of a DAS28 score reduction of at least 1.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||days||95% Confidence Interval|Mean
1424181|NCT01063062|Secondary|Percentage of Participants Achieving DAS28 Clinically Significant Improvement|DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.|Baseline, Weeks 4, 8, 12, 16, 20, 24|Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward.|||percentage of participants|||Number
1424199|NCT01062841|Secondary|Total Number of Residents With New MRSA (Methicillin Resistant Staphylococcus Aureus) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and were at-risk to acquire new MRSA colonization (not colonized at baseline)|||Number of Residents with New MRSA|Participants||Number
1424182|NCT01063062|Primary|Time to DAS28 Low Disease Activity|Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|24 Weeks|Intent-to-treat population included all participants who received at least one dose of study drug and had data for at least one follow-up variable available. Last observation carried forward.|||days||95% Confidence Interval|Mean
1424183|NCT01063062|Primary|Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2.|Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)|Intent-to-treat (ITT) population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward was applied for missing data.|||percentage of participants|||Number
1424184|NCT01063049|Secondary|The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature|Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).|After Colonoscopy||||units on a scale||Standard Deviation|Mean
1424185|NCT01063049|Primary|The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale|The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).|After Colonoscopy||||units on a scale||Standard Deviation|Mean
1424186|NCT01063036|Secondary|Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population|Selected criteria presented in each category. Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<). Creatinine data presented below were confirmed, ie, at least 2 consecutive values. On-treatment = after Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|N=treated participants with on-treatment laboratory test results.|||participants|||Number
1424187|NCT01063036|Secondary|Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population|Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough. Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant’s sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant’s sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S). Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy.|Baseline to Weeks 48, 96|All treated participants who met resistance testing criteria (primary non-response or virologic breakthrough) and were tested for resistance to both study drugs were analyzed. n = number of participants analyzed at Weeks 48 and 96.|||participants|||Number
1424188|NCT01063036|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. On-treatment = on Day 1 through last dose of study therapy + 5 days.|Day 1 to last dose of study drug plus 5 days; up to Week 96|All Treated participants were analyzed.|||participants|||Number
1424189|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline|HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline. Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline. Positive result for HBsAg was one of the inclusion criteria. Treated participants (HBsAg positive at baseline) were evaluated using NC=F. The method used was an Immunoassay testing – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized]. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
1424200|NCT01062841|Secondary|Number of Incident Feeding-tube Associated Pneumonias||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with indwelling feeding tube present (PEG tube), and had >1 follow-up visit|||Number of feeding-tube associated pneu|Participants||Number
1424201|NCT01062841|Secondary|Number of Incident Feeding Tube-associated Skin and Soft Tissue Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with an indwelling feeding tube present (PEG tube), and had >1 follow-up visit|||Numer of feeding-tube SSTIs|Participants||Number
1424279|NCT01061606|Secondary|Time to Progression||Time to progression is defined as the time from registration to disease progression.|The study concluded terminated early and patients were not followed.||||||
1424190|NCT01063036|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline|Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline. The method used: Immunoassay – ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized). Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg). Treated participants (HBsAg-positive at baseline) were evaluated using NC=F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, 96|All treated participants who were HBsAg-positive at baseline and were analyzed at Weeks 24, 48, and 96 (NC = F). An exact binomial 95% Confidence Interval was constructed.|||percentage of participants||95% Confidence Interval|Number
1424191|NCT01063036|Secondary|Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline|HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline, Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
1424192|NCT01063036|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline|Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit – procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug.|Baseline to Weeks 24, 48, and 96|All treated participants who were HBeAg-positive at baseline were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
1424193|NCT01063036|Secondary|Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population|HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96. Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F).|Weeks 24, 48, 96|All treated participants were analyzed at Weeks 24, 48 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
1424194|NCT01063036|Secondary|Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population|HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. Baseline was Day 1, prior to study drug administration.|Baseline to Weeks 12, 24, 48, 96|All treated participants with results at both baseline and on-treatment were analyzed. n=Number of treated participants with results at baseline and Week 12, Week 24, Week 48 and Week 96.|||log10 IU/mL||Standard Deviation|Mean
1424195|NCT01063036|Secondary|Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 24, Week 96|All treated participants were analyzed at Weeks 24 and 96 (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
1424196|NCT01063036|Primary|Percentage of Participants With a Virologic Response at Week 48 - Treated Population|Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ.|Week 48|All treated participants were analyzed (NC = F). An exact binomial 95% confidence interval was constructed.|||percentage of participants||95% Confidence Interval|Number
1424197|NCT01062841|Secondary|Total Number of Residents With New Resistant GNB (Ceftazidime or Ciprofloxacin Gram-negative Bacilli) Acquisition||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit, and who were at-risk to acquire a new R-GNB colonization (not colonized at baseline)|||Number of Residents with New R-GNB|Participants||Number
1424206|NCT01062841|Primary|Total Number of MRSA (Methicillin Resistant Staphylococcus Aureus) Isolated||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with >1 follow-up visit|||Total Number of MRSA isolates|||Number
1424207|NCT01062841|Secondary|Number of First Incident Urinary Catheter-associated Urinary Tract Infections||From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Participants with only a urinary catheter present and >1 follow-up visit|||Number of First CAUTI|Participants||Number
1424208|NCT01062841|Primary|Total Number of MDRO (Multidrug Resistant Organisms) Isolated|Total Number of MDROs isolated across all MDROs and all anatomic sites for all enrolled residents with indwelling devices over the duration of the study period|From enrollment up to 1 year, or until study withdrawal (indwelling device removed, discharged from facility, at resident request, death), or end of study|Residents enrolled with >1 follow-up visit|||Total Number of MDRO isolates|||Number
1424209|NCT01062763|Primary|Change of Diastolic Blood Pressure|Change of diastolic blood pressure from baseline to study end at four months.|4 months|Analyzed by intention to treat and last observation carried forward|||mm Hg||95% Confidence Interval|Mean
1424210|NCT01062763|Secondary|Adverse Effects||4 months|Intention to treat|||participants|||Number
1424211|NCT01062763|Primary|Change of of Systolic Blood Pressure|Change of systolic blood pressure from baseline to study end at four months.|4 months|Analysis by intention to treat using LOCF|||mm Hg||95% Confidence Interval|Mean
1424212|NCT01062425|Secondary|Incidence of Grade 3+ Toxicities|The number of patients with reported grade 3 and higher treatment-related toxicities as assessed by Common Terminology Criteria for Adverse Events version 4.0|From randomization to six months.|All randomized and eligible patients who started protocol treatment.|||participants|||Number
1424213|NCT01062425|Secondary|Progression-free Survival (PFS)|Progression-free survival time is defined as time from randomization to date of first progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive without progression are censored at the date of last contact. Progression is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|From randomization to time of first progression or death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.|||Months||95% Confidence Interval|Median
1424214|NCT01062425|Secondary|Overall Survival (OS)|OS will be estimated using the Kaplan-Meier method and differences between treatment arms will be tested using the log rank test. Multivariate analyses with the Cox proportional hazard model for OS will be performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors.|From randomization to time of death due to any cause. Patients are followed until death. Analysis occurs after all patients have been potentially followed for six months.|All randomized and eligible patients.|||Months||95% Confidence Interval|Median
1424215|NCT01062425|Primary|6-month Progression-free Survival Rate|Six-month progression-free survival is the rate of patients who have NOT progressed at six months, where progressive disease is defined as any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. Progression will be determined by central review of MRI exams, assessed using MacDonald criteria for progression versus response on 2D T1 and T2 weighted images.|From randomization to 6 months.|Randomized eligible patients with evaluable data at six months. (From the randomized eligible patients, 2 patients withdrew prior to 6 months and 1 did not have an evaluable scan on the placebo arm, while 4 withdrew before 6 months, 3 did not have an evaluable scan, and 2 did not receive protocol treatment on the cediranib arm.)|||percentage of participants||95% Confidence Interval|Number
1424216|NCT01062399|Secondary|Phase II: Distribution of Worst Adverse Event Grade|The worst/highest grade of any adverse event reported was determined for each patient. The percentage of patients in each grade level is reported. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase II patients who started study treatment and had adverse events assessed.|||percentage of patients|||Number
1424217|NCT01062399|Secondary|Phase I: Distribution of Worst Adverse Event Grade|"AE reporting in Phase I was split up by treatment timing: concurrent treatment (RT, TMZ, RAD001); post-RT treatment (TMZ, RAD001) along with all AE's reported in follow-up.~The worst/highest grade of any adverse event reported in each time period was determined for each patient. The percentage of patients in each grade level is reported. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE."|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase I patients who started the corresponding study treatment and had adverse events assessed.|||percentage of participants|||Number
1424218|NCT01062399|Secondary|Phase II: Overall Survival (OS)|Overall survival time is defined as time from/randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase II patients|||months||95% Confidence Interval|Median
1424280|NCT01061606|Secondary|Time to Treatment Failure|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|From study registration to the date patients end treatment, assessed up to 3 years|The study concluded terminated early and patients were not followed.||||||
1439463|NCT00939211|Secondary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose|Average FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h||||L||Standard Deviation|Mean
1424219|NCT01062399|Primary|Phase II: Progression-free Survival (PFS)|Using the Response Assessment in Neuro- Oncology (RANO) criteria, the progression is defined by any of the following: > 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease. PFS time is defined as time from registration to date of progression, death, or last known follow-up (censored). PFS rates are estimated using the Kaplan-Meier method.|Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.|Eligible phase II patients|||months||95% Confidence Interval|Median
1424220|NCT01062399|Primary|Phase I: Number of Patients With Dose-limiting Toxicity (DLT)|DLT is defined as any of the following events occurring during the first 8 weeks of treatment with RAD001 and temozolomide and attributable to the study drugs: any grade 3 or 4 thrombocytopenia, grade 4 anemia, or grade 4 neutropenia lasting more than 7 days; any non-hematologic grade 3 or greater adverse event (AE), excluding alopecia, despite maximal medical therapy; any grade 4 radiation-induced skin changes; failure to recover from adverse events to be eligible for re-treatment with RAD001 and temozolomide within 14 days of the last dose of either drug; or any episode of non-infectious pneumonitis grade 2, 3, or 4 of any duration. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE|From start of treatment to eight weeks.|First 6 eligible phase I patients at each dose level who started study treatment|||Participants|||Count of Participants
1424221|NCT01062308|Secondary|Passive Range of Motion (ROM)|Passive range of motion (ROM) of shoulder was measured with full circle goniometer. The normal range of movement of flexion and abduction is 180 degree.|14 days and 30 days|On the basis of follow up completion|||degree||95% Confidence Interval|Mean
1424222|NCT01062308|Primary|Pain: Visual Analog Scale|Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 (“No Pain”) to 100 (“Worst Pain Imaginable”) Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability|14 days and 30 days|On the basis of complete follow up|||mm||95% Confidence Interval|Mean
1424223|NCT01062269|Secondary|Weighted vs. Unweighted BASA Scale|The total aggregate scores for the complete BASA scale were calculated for Cholestyramine 4g, Cholestyramine 12g, and Tang. The total best possible score was 20 and the total worst possible score was 4. A weighted aggregate BASA scale score was also calculated for the Cholestyramine 4g, Cholestyramine 12g, and Tang. The best possible weighted score was 60 and the worst possible weighted score was 4.|1 Day||||Units on Scale||Standard Deviation|Median
1424224|NCT01062269|Primary|Patient Acceptability of Orange-flavored Generic Questran (Cholestyramine) vs. Tang (a Commercial Powdered Orange Drink) Via 2 Versions of a Bile Acid Sequestrant Acceptability (BASA) Scale.|The Bile Acid Sequestrant Acceptability Scale has 4 scoring categories: taste, texture, appearance and mixability. Participants rank each category separately. The best possible score for each category is 5 and the worst possible score is 1.|1 Day|Only 42 total subjects were randomized and analyzed. However, all 42 subjects received all 3 treatment arms, just in varying order of administration.|||Units on Scale||Standard Deviation|Mean
1424225|NCT01062256|Other Pre-specified|Number of Participant With Cough Severity|Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate.|Baseline|ITT|||Participants|||Number
1424226|NCT01062256|Secondary|Number of Participants With Global Evaluation of Study Medication|"Participant-rated evaluation of study product; Participants responded to the following question:~How would you rate this product as a cough reliever?” 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent"|4 hours postdose or early termination|ITT|||participants|||Number
1424227|NCT01062256|Secondary|Change From Baseline in Cough Severity Scale|Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement.|1, 2, 3, and 4 hours postdose|ITT|||units on a scale||Standard Deviation|Mean
1424228|NCT01062256|Secondary|Number of Cough Bouts Within Each 15-minute Time Interval Postdose|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals.|every 15 minutes postdose up to 240 minutes postdose|ITT|||cough bouts||Standard Deviation|Mean
1424229|NCT01062256|Secondary|Number of Cough Bouts Over 2-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 2 hours postdose|ITT|||cough bouts||Standard Deviation|Mean
1424382|NCT01060540|Secondary|Insulin Resistance (HOMA2-IR)|"Calculated using the updated homeostasis model assessment (HOMA) calculator at http://www.dtu.ox.ac.uk/homacalculator/~Higher numbers indicate higher insulin resistance. There are no established cutoffs indicating impaired resistance."|3 months||||units on a scale||Standard Deviation|Mean
1424230|NCT01062256|Primary|Number of Cough Bouts Over 4-hour Postdose Period|Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.|0 to 4 hours postdose|Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product.|||Cough bouts||Standard Deviation|Mean
1424231|NCT01062230|Primary|Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1|All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.|Baseline and Day 1||||% change|||Number
1424232|NCT01062165|Primary|Total Clearance of Caspofungin||0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)||||L/hr||Standard Deviation|Mean
1424233|NCT01062113|Secondary|Differences in Pain Intensity (PI) Measured by VAS Among Participants|The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.|Pre-additional dose (baseline) and 2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).|||mm||Standard Deviation|Mean
1424234|NCT01062113|Secondary|Pain Intensity Measured by Visual Analog Scale (VAS)|The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.|2 hours post-additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).|||mm||Standard Deviation|Mean
1424235|NCT01062113|Secondary|Number of Participants in Each Pain Intensity (PI) With 4 Categories|"Pain intensity was entered in the patient diary on the following categories: No pain, Mild pain, Moderate pain and Severe pain."|2 hours after additional dose|The full analysis set (FAS), Baseline Observation Carried Forward (BOCF).|||participants|||Number
1424236|NCT01062113|Primary|Efficacy Rate (Percentage) of Patient’s Impression|"Patient’s impression was assessed by self-report and was entered in the patient diary, based on the following categories: Excellent,  Good, Fair and Poor.~Efficacy rate was calculated from the following formula, The number of participants assessed as Excellent or Good over total participants multiplied by 100."|2 hours post-additional dose|The full analysis set (FAS). This analysis set consisted of randomized participants who received the additional dose of the study drug and who were assessed for at least one efficacy endpoint after randomization.|||percentage of participants|||Number
1424237|NCT01062074|Primary|Percentage of Participants With Any Adverse Drug Reaction|An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol|||Percent of participants|||Number
1424238|NCT01062074|Primary|Percentage of Participants With Any Adverse Experience|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 14 days after any GARDASIL vaccination|Participants who received at least 1 vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol|||Percent of participants|||Number
1424239|NCT01062061|Primary|Percentage of Participants With One or More Unexpected SAEs|Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination||||percentage of participants|||Number
1424240|NCT01062061|Primary|Percentage of Participants With One or More Serious ADRs|A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|Serious ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
1424241|NCT01062061|Primary|Percentage of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.|Up to 42 days after vaccination|SAEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
1424242|NCT01062061|Primary|Percentage of Participants With One or More Unexpected ADRs|An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out|Up to 42 days after vaccination|Unexpected ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
1424243|NCT01062061|Primary|Percentage of Participants With One or More Unexpected AEs|Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome|Up to 42 days after vaccination|Unexpected AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
1424244|NCT01062061|Primary|Percentage of Participants With One or More Adverse Drug Reactions (ADRs)|An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out|Up to 42 days after vaccination|ADRs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
1424281|NCT01061606|Secondary|Duration of Response, Defined for All Evaluable Patients Who Have Achieved an Objective Response as the Date at Which the Patient’s Objective Status is First Noted to be Either a CR or PR to the Date Progression is Documented|Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years|The study concluded terminated early and patients were not followed.||||||
1424383|NCT01060540|Primary|Weight|weight 3 months post-enrollment|3 months||||kg||Standard Deviation|Mean
1424245|NCT01062061|Primary|Percentage of Participants With One or More AEs by Age|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
1424246|NCT01062061|Primary|Percentage of Participants With One or More AEs by Gender|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|AEs were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||percentage of participants|||Number
1424247|NCT01062061|Primary|Percentage of Participants With One or More Adverse Events (AEs)|"An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event.~Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time."|Up to 42 days after vaccination|Adverse events were reported for participants in the safety population: participants administered VARIVAX in usual practice and not discontinued for a reason given in the Participant Flow|||Percentage of Participants|||Number
1424248|NCT01061866|Primary|Change From Baseline in the Mean Number of Daily Seizures at 1 Year.||Baseline 3 months and 1 year of treatment|males of 25 years old mean with refractory epilepsy, antiepileptic treatment and electroencephalographic study|||Number of Seizures||Standard Error|Mean
1424249|NCT01061775|Secondary|Calorie Intake Based on 3-day Diet Records|Dietary data were collected via 3-day diet records (Crawford et al. 1994) twice during the study, at baseline and week 24. Three-day diet records were collected on consecutive days including one weekend day. A registered dietitian (RD) instructed subjects on dietary data collection at baseline appointment. Depending on the age and capacity of the subject, the patient, parent or a collaboration of both recorded dietary intake. A RD entered dietary data into Nutritionist Pro software (First DataBank, SanBruno, CA) and the mean difference was analyzed.|24 weeks|The sample size was small due to missing data|||kcals||95% Confidence Interval|Mean
1424250|NCT01061775|Secondary|Childhood Eating Behavior Questionnaire (CEBQ)|The Child Eating Behaviour Questionnaire (CEBQ) was designed as parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. We utilized the CEBQ as a self-report measure during this study; it has not been validated for such use. For the purposes of this study, we looked at the Satiety Responsiveness Subscale Scores (5 questions; total scores could range from 5-25 with lower scores denoting a lower level of satiety). The results reported show the change between baseline and week 24 scores.|24 weeks|Paired t-tests were performed to compare the satiety survey (continuous). Three subjects discontinued prior to completing the Week 24 CEBQ.|||units on a scale||95% Confidence Interval|Mean
1424251|NCT01061775|Primary|Waist to Height Ratio (WHtR)|Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks|24 weeks|All analyses were performed using SPSS (version 20.0.0, SPSS Inc, Chicago, IL).|||percentage||Standard Deviation|Mean
1424252|NCT01061775|Primary|BMI Change|BMI was collected at baseline and 24 weeks|24 weeks|The effects of exenatide on BMI were analyzed using a paired t-test comparing BMI at baseline with BMI after six months of treatment with each patient serving as his or her own control.|||kg/m^2||95% Confidence Interval|Mean
1424253|NCT01061736|Secondary|Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52|Major clinical response was defined as an ACR70 response maintained for at least 24 consecutive weeks. ACR70 response uses the same criteria as for ACR20 but requires 70% improvement. In the primary approach, data collected after treatment discontinuation or rescue was set to missing. No imputation of missing post-baseline values was performed. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.|Baseline up to Week 52|ITT population which included all participants randomized after dose selection (cohort 2).|||Percentage of participants|||Number
1424254|NCT01061736|Primary|Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52|The Sharp method modified by D. van der Heijde involves separate scores for erosions and joint space narrowing based on radiographs to assess the degree of structural damage. Total score range from 0 (normal) to 448 (worst possible total score). An increase in total score represents progression of structural damage. Missing data were imputed by the linear extrapolation method.|Baseline, Week 52|Cohort 2 ITT population and included participants with available data of mTSS at baseline and on or before Week 52.|||units on a scale||Standard Deviation|Mean
1424282|NCT01061606|Secondary|Overall Survival|Time to event distributions will be estimated using the Kaplan-Meier method.|From registration to death, assessed up to 3 years|The study concluded terminated early and patients were not followed.||||||
1424255|NCT01061736|Primary|Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16|HAQ-DI was a participant-reported questionnaire that assesses the difficulty of performing daily activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Overall score range from 0=least difficulty to 3=extreme difficulty. An increase in the score indicates a worsening of physical function while a decrease in the score represents improvement. Data collected after treatment discontinuation was set to missing.|Baseline, Week 16|Cohort 2 ITT population only and included participants with available data of HAQ-DI at baseline and on or before Week 16.|||units on a scale||Standard Deviation|Mean
1424256|NCT01061736|Primary|Part B: Percentage of Participants Achieving ACR20 Response at Week 24|ACR20 improvement responses were determined without imputation of missing post-baseline values. In addition data collected after treatment discontinuation or rescue was set to missing. Responder status was determined if possible. With these rules, participants automatically became non-responders for all time points beyond the time point they started rescue treatment or discontinued study treatment.|Baseline to Week 24|ITT population which included all participants randomized after dose selection (cohort 2).|||Percentage of participants|||Number
1424257|NCT01061736|Primary|Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 response was defined, based on guidelines set forth by the American College of Rheumatology (ACR), as ≥20 % improvement in tender joint count and swollen joint count as well as ≥20% improvement in at least 3 of 5 following measures: C-Reactive Protein (CRP), Participant assessment of pain; Participant's global assessment of disease activity; Physician global assessment of disease activity; and Health Assessment Question-Disability Index (HAQ-DI). Missing data imputed by Last Observation Carried Forward (LOCF).|Baseline to Week 12|Part A Intent-to-treat (ITT) population defined as all randomized participants.|||Percentage of participants|||Number
1424258|NCT01061723|Secondary|Change From Baseline in ASAS Individual Components at Week 12|ASAS consists of 4 individual components: Participant global assessment to assess the disease activity over the last week on a 0 (no pain) - 10 (severe pain) NRS; back pain which consist of the mean of the nocturnal back pain and the total back pain at every visit on a 0 (no pain) - 10 (most severe pain) NRS; inflammation measured as the mean of the last 2 BASDAI questions (intensity and duration of morning stiffness) and physical function measured as mean of 10 scores of BASFI at every visit on 0 (easy) -10 (impossible) NRS. Lower score corresponds to a better functioning.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASAS assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
1424259|NCT01061723|Secondary|Change From Baseline in Hs-CRP at Week 12|Participant's blood samples were collected at screening, baseline before dosing and at every visit to evaluate the level of hs-CRP. The hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with Hs-CRP assessment at specified time-points.|||mg/dL||Standard Deviation|Mean
1424260|NCT01061723|Secondary|Change From Baseline in Swollen Joint Index at Week 12|44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with swollen joint count assessment at specified time-points.|||Joints||Standard Deviation|Mean
1424261|NCT01061723|Secondary|Change From Baseline in Chest Expansion at Week 12|The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with chest expansion assessment at specified time-points.|||cm||Standard Deviation|Mean
1424262|NCT01061723|Secondary|Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12|ASAS 5/6 responder had an improvement of 20% in 5 of 6 domains (physical function, back pain, participant global assessment, inflammation, spinal mobility and acute phase reactants) of ASAS-IC without deterioration in the 6th domain. Spinal mobility was assessed by the mean of the 5 BASMI scores on the 11-point scale (score ranges from 0-10) and the hs-CRP for the acute phase reactant.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.|||percentage of participants|||Number
1424263|NCT01061723|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12|ASspiMRI-a scoring system was used on all MRIs to score the level of the disease. MRIs were obtained using 1.0 or 1.5 Tesla scanners and phased array coils. Sagittal images of the upper (C2 to T10) and lower (T8 to S1) spine were used using both T1 weighted spin echo and fat saturated Short Tau Inversion Recovery (STIR) sequences. Each vertebral body unit was given an activity score based on the amount of bone marrow edema or erosion. Both T1 and STIR sequences were analyzed for change. Total spine ASspiMRI-a score in the Berlin modification range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from baseline indicates an improvement from baseline. The higher the negative value the higher the reduction of inflammation.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with ASspiMRI-a assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
1424264|NCT01061723|Secondary|Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12|The range of motion was measured by the BASMI (11-point scale) including chest expansion in cm. It composed of 5 clinical measurements associated with a score: tragus to wall distance, modified schober’s test, lateral spinal flexion, intermalleolar distance and cervical rotation. BASMI score was calculated by dividing the total of the score by 5, and the score ranges from 0-10. Higher BASMI score indicates more severe limitation of movement.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed=participants with BASMI score assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
1424283|NCT01061606|Primary|Progression Free Survival|The 6-month progression-free rate is defined as the total number of efficacy-evaluable patients on study without documentation of disease progression 6 months from registration divided by the total number of efficacy-evaluable patients enrolled on study.|6 months from registration|The study concluded terminated early and patients were not followed.||||||
1424265|NCT01061723|Secondary|Change From Baseline in BASDAI Score at Week 12|BASDAI comprises of a 0 (no pain) -10 (very severe pain) NRS, used to answer 6 questions (Q) related to symptoms of AS (fatigue/tiredness, neck, back or hip pain, pain / swelling in joints, discomfort in tender areas, morning stiffness duration and morning stiffness severity). The BASDAI total score was calculated by computing the mean of Q5 and Q6 and adding it to the sum of Q1 to Q4. This score was then divided by 5. BASDAI total score=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with BASDAI score assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
1424266|NCT01061723|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12|ASDAS consists of five components: (Total back pain assessed by BASDAI question 2 on a 0 [no pain] - 10 [most severe pain] NRS, participant global of disease activity on a 0 [none] – 10 [severe] NRS, peripheral pain/swelling assessed by BASDAI question 3 on a 0 [none] - 10 [most severe pain] NRS, duration of morning stiffness assessed by BASDAI question 6 on a NRS from 0 [0 hour] - 10 [2 or more hours] and hs-CRP in mg/L). ASDAS score was calculated as follows: 0.121 x total back pain + 0.110 x participant global of disease activity + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(CRP + 1). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5).|Baseline, Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASDAS score assessment at specified time-points.|||units on a scale||Standard Deviation|Mean
1424267|NCT01061723|Secondary|Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12|Participants were classified as having achieved ASAS partial remission if they had a value ≤ 2 units on a 0 -10 NRS in each of the 4 domains: (participant global assessment, back pain, physical function and inflammation) of the ASAS-IC.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.|||percentage of participants|||Number
1424268|NCT01061723|Secondary|Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12|Clinical response to treatment for ASAS40 was assessed according to ASAS40 criteria. Treatment response for ASAS40 was defined as an improvement by a decrease of ≥40% and ≥2 units on a 0 (no pain)-10 (most severe pain) NRS in at least 3 of the 4 ASAS-IC domains (participant global assessment, back pain, physical function and inflammation) and no worsening (increase in score) at all in the remaining 4th domain.|Baseline to Week 12 (LOCF)|ITT population. Missing data was imputed using LOCF.|||percentage of participants|||Number
1424269|NCT01061723|Primary|Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12|Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index [BASFI]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain.|Baseline to Week 12 (Last Observation Carried Forward [LOCF])|Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using LOCF.|||percentage of participants|||Number
1424270|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Proportion of Responders||24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed.||||||
1424271|NCT01061710|Secondary|Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)||24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed.||||||
1424272|NCT01061710|Secondary|Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert|An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.|||Participants|||Number
1424273|NCT01061710|Primary|Number of Responders to Varenicline Treatment|Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.|24 weeks|The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population.|||Participants|||Number
1424274|NCT01061710|Primary|Number of Participants With Treatment-Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.|24 weeks|The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.|||Participants|||Number
1424275|NCT01061671|Secondary|Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)||up to 37 months|Analysis excludes participants without any follow-up data.|||events per patient year||95% Confidence Interval|Mean
1424276|NCT01061671|Secondary|Change in FEV1 (% Pred) From Baseline to Last Measure||Baseline, last measure at up to 37 months|Analysis excludes participants without any follow-up data.|||percent predicted||90% Confidence Interval|Median
1424277|NCT01061671|Secondary|Time to First COPD Exacerbation||up to 37 months|Analysis excludes participants without any follow-up data.|||Days to the first exacerbation||95% Confidence Interval|Median
1424278|NCT01061671|Primary|Rates of COPD Exacerbations||up to 37 months|Analysis excludes participants without any follow-up data.|||exacerbations/person-year||Standard Deviation|Mean
1424285|NCT01061567|Secondary|Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score|The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in the Morisky scale for baseline and at visit 3.|||units on a scale||Standard Deviation|Mean
1424286|NCT01061567|Secondary|Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction|The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.|Baseline and the end of study (up to 16 weeks)|Patients from FAS with evaluable data in VAS at baseline and at visit 3.|||units on a scale||Standard Deviation|Mean
1424287|NCT01061567|Secondary|Clinical Global Impression of Improvement (CGI-I) Responder Rate|The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson’s disease. The clinician rated how much a patient’s condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.|Baseline and the end of study (up to 16 weeks)|Patients from FAS|||percentage of participants|||Number
1424288|NCT01061567|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score|Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.|Baseline and the end of study (up to 16 weeks)|Patients from the Full Analysis Set (FAS) which includes all treated patients who have data for at least one post baseline visit.|||units on a scale||Standard Deviation|Mean
1424289|NCT01061567|Primary|Proportion of Patients With Withdrawals Due to Adverse Events.|Patients who discontinued treatment due to adverse events including deaths.|16 weeks|Patients from the Treated Set (TS).|||proportion of participants|||Number
1424290|NCT01061567|Primary|Incidence of Adverse Events|The number of patients with any adverse events (AEs), patients with drug-related AEs.|From the treatment initiation to the end of study, on average 92.9 days|Patients from the Treated Set (TS).|||participants|||Number
1424291|NCT01061528|Primary|Number of Participants With Biochemically Verified Smoking Abstinence|"Carbon monoxide of expired air~Salivary cotinine level of saliva"|Six months||||Participants|||Count of Participants
1424292|NCT01061476|Primary|Change in AHI|The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).|Comparisons were made between the 2 nights|Although all participants went through the sleep studies, there was insufficient data in 1 subject to assess sleep apnea severity and was therefore excluded from analysis.|||events/h||Standard Deviation|Mean
1424293|NCT01061385|Secondary|Percentage of Subjects With >=25% Excess Weight Loss (EWL)|a between-group comparison of percentage of treatment subjects achieving >=25% EWL (using the Metropolitan Life Tables (ML) method) compared to the percentage of control group subjects achieving >= 25%EWL at 12 months|12 months||||percentage of subjects|||Number
1424294|NCT01061385|Primary|%Excess Weight Loss|the difference between the %EWL between treatment and control groups must be clinically significant|36 Weeks||||percent excess weight loss||Standard Deviation|Mean
1424295|NCT01061359|Secondary|Time to Recurrence (DFI)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Median time to recurrence was not reached.|||months||Full Range|Median
1424296|NCT01061359|Secondary|Time to Progression (TTP)||3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|16.3% of patients had experienced disease progression by the end of the study. As this is less than 50% the median time to progression is not defined.|||months||Full Range|Median
1424297|NCT01061359|Primary|Percentage of Participants With Disease Free Survival (DFS)|Percentage of participants with DFS who completed 5 year follow-up visit.|3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y|Intent to treat (ITT)|||Percentage of participants|||Number
1424298|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTE4|Concentrations of LTE4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.|||pg/mL||Standard Deviation|Geometric Mean
1424299|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTD4|Concentrations of LTD4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.|||pg/mL||Standard Deviation|Geometric Mean
1424300|NCT01061333|Secondary|Allergen-induced Concentrations of Sputum LTC4|Concentrations of LTC4 in sputum at 2 hours post-allergen challenge|2 hours post allergen challenge|Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.|||pg/mL||Standard Deviation|Geometric Mean
1424301|NCT01061333|Secondary|Allergen-induced Changes in Urinary Leukotriene (LT) E4|Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed|||Fold change over baseline||Standard Deviation|Geometric Mean
1424302|NCT01061333|Secondary|Allergen-induced Changes in Urinary 9P|Fold change over baseline in Urinary 9P at 2 hours post allergen challenge|Baseline and 2 hours post allergen challenge|Only participants with baseline values were analyzed|||Fold change over baseline||Standard Deviation|Geometric Mean
1424303|NCT01061333|Primary|Change in Plasma 9P at 20 Minutes|Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge|Pre-allergen challenge and 20 minutes post allergen challenge||||Fold change over baseline||Standard Deviation|Geometric Mean
1424306|NCT01061177|Secondary|Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months|PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.|12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
1424307|NCT01061177|Secondary|Rate of Molecular Response (MR4^5) by 18 Months|"MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).~BCR = Breakpoint Cluster Region gene/BCR gene product~BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase"|by 18 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.|||Percentage of participants|||Number
1424308|NCT01061177|Secondary|Rate of Molecular Response (MR4^0) by 18 Months|"MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.~BCR = Breakpoint Cluster Region gene/BCR gene product~BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase"|by 18 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.|||Percentage of participants|||Number
1424309|NCT01061177|Secondary|Percentage of Participants With Overall Survival at 12 and 24 Months|OS was defined as the time between the date of Day 1 (first treatment) and the date of death from any cause. Deaths which occurred after the 24-month time window and which were occasionally reported by some Investigators were excluded from the analysis. This is in agreement with the protocol stating that patients were to be followed for survival and progression to AP/BC up to 24 months after the participants treatment start.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
1424310|NCT01061177|Secondary|Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months|CHR was defined as all of the following present for ≥ 4 weeks in the peripheral blood: WBC count < 10 x 109/L, Platelet count < 450 x 109/L, No circulating peripheral blood blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood, The presence of < 5% basophils, No evidence of disease-related symptoms and extramedullary disease, including spleen and liver. Loss of CHR was defined as the appearance of any of the following after having achieved a CHR confirmed by a second determination ≥ 4 weeks later (unless associated with progression to AP/BC or death, which was considered to be a confirmed loss of CHR event on its own): WBC count that increased to > 20.0 x 109/L, Platelet count that increased to ≥ 600 x 109/L, Any palpable spleen, defined as size of spleen below costal margin > 5 cm, Appearance of > 5% myelocytes plus metamyelocytes, or any promyelocytes or blasts in the peripheral blood.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of prticipants|||Number
1424311|NCT01061177|Secondary|Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months|MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).|12 and 24 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered.|||Percentage of participants|||Number
1424312|NCT01061177|Secondary|Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months|MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.|12 and 24 months|The ITT_MR population was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening ie, b3a2 and/or b2a2 were considered. This population was referred to as ITT_MR.|||Percentage of participants|||Number
1424313|NCT01061177|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months|PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.|12 months, 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
1424314|NCT01061177|Secondary|Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months|EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (i.e. 91 + 15 days).|at 12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
1424315|NCT01061177|Secondary|Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months|"The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.~BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy."|at 12 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
1424316|NCT01061177|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months|Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.|12 and 24 months|The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.|||Percentage of participants|||Number
1424317|NCT01061177|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months|CCyR parameters were defined as 0% Philadelphia positive (Ph+) metaphases. Loss of CCyR was defined as a patient exceeding the CCyR criteria (ie, > 0% Ph+ metaphases) at a subsequent visit after the patient had achieved CCyR.|12 and 24 months|The ITT_CyR population was a subset of the ITT population including the Ph+ patients at screening was considered. Patients who had either no metaphases recorded at screening bone marrow or only negative metaphases recorded at screening bone marrow but had Ph+ metaphases at any visits after screening were also part of this population.|||Percentage of participants|||Number
1424318|NCT01061177|Secondary|Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months|"MMR was defined as BCR-ABL ratio (IS) ≤ 0.1% in a peripheral blood sample. BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR (breakpoint cluster region) gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins."|12 months, 24 months|Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.|||Percentage of participants|||Number
1424319|NCT01061177|Secondary|Rate of Event Free Survival at 12 and 24 Months|EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (ie, 91 + 15 days), Not achieving CCyR up to 18 months (ie, 548 + 15 days), whichever is earlier.|at 12 and 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
1424320|NCT01061177|Secondary|Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months|"The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC.~BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy."|at 12 and 24 months|The intent-to-treat (ITT) population consisted of all patients who received at least one dose of study drug.|||Percentage of participants|||Number
1424321|NCT01061177|Primary|Percentage of Participants With Molecular Response (MR4^0) at 18 Months|MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts.|at 18 months|Intent-to-treat_Molecular (ITT_MR) analysis set was a subset of the ITT population including the patients with typical BCR-ABL transcript at screening.|||Percentage of Participants|||Number
1424322|NCT01061151|Secondary|Maternal Health Component: Cost-effectiveness|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|From study entry until July 7, 2015.|||||||
1424323|NCT01061151|Secondary|Maternal Health Component: Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
1424324|NCT01061151|Secondary|Maternal Health Component: Quality of Life|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|From study entry until July 7, 2015.|||||||
1424325|NCT01061151|Secondary|Maternal Health Component: Self-reported Adherence|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|From study entry until July 7, 2015.|||||||
1424326|NCT01061151|Secondary|Maternal Health Component: Viral Resistance|This secondary outcome required additional funding for laboratory testing which was not awarded because this outcome was deemed no longer scientifically important, so this outcome is not reported.|From study entry until July 7, 2015.|||||||
1424327|NCT01061151|Secondary|Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results|The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
1424328|NCT01061151|Secondary|Maternal Health Component: Incidence of Tuberculosis|Incidence of tuberculosis.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
1424329|NCT01061151|Secondary|Maternal Health Component: Composite Endpoint of Any Condition Outlined in Appendix IV of the Protocol or Death|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
1424330|NCT01061151|Secondary|Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events|“HIV/AIDS-related event” refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
1424331|NCT01061151|Secondary|Maternal Health Component: Incidence of HIV/AIDS-related Event or Death|“HIV/AIDS-related event” refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
1424332|NCT01061151|Secondary|Maternal Health Component: Other Targeted Medical Conditions|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
1424333|NCT01061151|Secondary|Maternal Health Component: Number of Cardiovascular or Other Metabolic Events|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
1424334|NCT01061151|Secondary|Maternal Health Component: Incidence of HIV/AIDS-related Events|“HIV/AIDS-related event” refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
1424335|NCT01061151|Secondary|Maternal Health Component: Composite Endpoint of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event|This secondary outcome was not included in the primary analyses. Given the results of the primary analyses the protocol team decided that this outcome was no longer scientifically important and resources should not be spent on analyzing it.|From study entry until July 7, 2015.|||||||
1424336|NCT01061151|Secondary|Maternal Health Component: Incidence of AIDS-defining Illness|“AIDS-defining illness” refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
1424337|NCT01061151|Secondary|Maternal Health Component: Incidence of Death||From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years||95% Confidence Interval|Number
1424338|NCT01061151|Secondary|Postpartum Component: Functional Maternal Antibody and HIV-envelope Binding Responses in Breast Milk and Plasma, Until Cessation of Breastfeeding or 18 Months Postpartum, Whichever Comes First|This secondary outcome required additional funding for laboratory testing. Results will be reported to ct.gov when available.|Measured through the time of cessation of breastfeeding or 18 months postpartum, whichever comes first|||||||
1424339|NCT01061151|Secondary|Postpartum Component: Pharmacokinetic Parameters of ARV Drugs Measured in Maternal Plasma, Hair, Breast Milk, and Infant Blood (Plasma or Dried Blood Spot) Samples Collected at Birth; Weeks 1, 6, 14, and 26; and Subsequent Visits During Breastfeeding|This secondary outcome required additional funding for laboratory testing. Results will be reported to ct.gov when available.|Measured through the last study visit during breastfeeding, or 18 months postpartum, whichever comes first|||||||
1424340|NCT01061151|Secondary|Postpartum Component: Cost-effectiveness and Feasibility of the Study ARV Prophylaxis Regimens|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured at the end of the 5-year study period|||||||
1424341|NCT01061151|Secondary|Postpartum Component: Rates and Patterns of Maternal and Infant Resistance to the Maternal and Infant ARV Regimens|This secondary outcome required additional funding for laboratory testing which was not awarded because this outcome was deemed no longer scientifically important, so this outcome is not reported.|Measured at the end of the 5-year study period|||||||
1424342|NCT01061151|Secondary|Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured through complete cessation of breastfeeding or 18 months of age, whichever comes first|||||||
1424343|NCT01061151|Secondary|Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery|Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair)|Measured at 12 and 24 months post-delivery|All live-born infants were included in the analyses. 4 infants with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.|||Probability||95% Confidence Interval|Number
1424445|NCT01060007|Secondary|Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity||1 year (completion of all treatment)||||participants|||Number
1439464|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose|Trough FEV1 value|22 h, 24 h, 26 h||||L||Standard Deviation|Mean
1424344|NCT01061151|Secondary|Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery|Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.|Measured through 24 months post-delivery|All M-I pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 3 M-I pairs with no post-randomization data were included and censored at the date of randomization. Analyses were intent to treat.|||Probability||95% Confidence Interval|Number
1424345|NCT01061151|Secondary|Antepartum Component: Antepartum Change in HBV DNA Viral Load Between Week 8 and Baseline Levels (Using Log HBV DNA) Among Women With Detectable HBV DNA Viral Loads at Baseline and Other HBV Outcome Measures|This secondary outcome required additional funding for laboratory testing. Results will be reported to ct.gov when available.|Measured at Week 8|||||||
1424346|NCT01061151|Secondary|Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery|Analysis used the principle of intent to treat.|Measured at the time of delivery|Analysis includes only mothers with HIV RNA data at delivery. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
1424347|NCT01061151|Secondary|Antepartum Component: Cost Effectiveness and Feasibility of the Trial ARV Regimens|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured at the end of the 5-year study period|||||||
1424348|NCT01061151|Secondary|Antepartum Component: Maternal and Infant Viral Resistance to the Maternal and Infant ARV Strategies|This secondary outcome required additional funding for laboratory testing which was not awarded because this outcome was deemed no longer scientifically important, so this outcome is not reported.|Measured at the end of the 5-year study period|||||||
1424349|NCT01061151|Secondary|Antepartum Component: Adherence to the Maternal Antiretroviral (ARV) Regimen, as Measured by Maternal Report|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured through the Week 1 postpartum study visit|||||||
1424350|NCT01061151|Secondary|Antepartum Component: Overall and HIV-free Infant Survival Through 24 Months of Age (in Conjunction With Infants in the Postpartum Component)|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Measured through 24 months of age|||||||
1424351|NCT01061151|Secondary|Antepartum Component: Number of Infant HIV Infections|Detected by HIV NAT positivity|Measured at the birth (<= 3 days postpartum) visit|Analysis is among the live births with HIV test results summarized in the maternal-infant set (the worst outcome summarized for multiple births to the same mother). Analysis used the principle of intent to treat.|||Participants|||Count of Participants
1424352|NCT01061151|Primary|Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death|AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group.|From study entry until July 7, 2015, an average of 94 weeks of follow-up.|This analysis includes mothers on HAART in the Antepartum component and who were eligible and randomized as part of the Postpartum Component or the Maternal Health Component. Analysis used the intent to treat principle.|||New cases per 100 person-years|||Number
1424353|NCT01061151|Primary|Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events|These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).|Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first|All mothers were included in the analyses. 15 mothers with no post-randomization data were included and censored at the date of randomization in the analyses. Analyses were intent to treat.|||New cases per 100 person-years|||Number
1424354|NCT01061151|Primary|Postpartum Component: Incidence of Confirmed Infant HIV Infection|Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event.|Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first|All Mother-Infant (M-I) pairs, except 1 M-I pair where infant was infected at date of randomization, were included in the analyses. 35 M-I pairs with no post-randomization HIV test results were included and censored at the date of randomization in the analyses. Analyses were intent to treat.|||New cases per 100 person-years|||Number
1424355|NCT01061151|Primary|Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)|Composite outcome|Measured at birth|Includes mothers with confirmed infant birth outcome as live birth, stillbirth, or spontaneous abortion and outcome assessments. Multiple gestation pregnancies (twins and triplets) were summarized at the unique mother level. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
1424356|NCT01061151|Primary|Antepartum Component: Number of Mothers With Obstetrical Complications||Measured through the Week 1 postpartum study visit|Mothers who do not have any obstetrical complications information available after study entry are not included. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
1424357|NCT01061151|Primary|Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events|These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com).|Measured through the Week 1 postpartum study visit|Mothers with no safety data available after baseline were not included. Analysis used the principle of intent to treat.|||Participants|||Count of Participants
1428834|NCT01018511|Secondary|Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||h||Geometric Coefficient of Variation|Geometric Mean
1424358|NCT01061151|Primary|Antepartum Component: Number of Confirmed Infant HIV Infections|Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point|Measured at birth or Week 1 study visit|Analysis includes data from periods 1 and 2. Analysis is among the live births with HIV test results summarized for the maternal-infant set (the worst outcome summarized for cases of multiple births). Analysis used the principle of intent to treat.|||Participants|||Count of Participants
1424359|NCT01061034|Secondary|Platelet Function Tests|"Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.~the results reflects the percent of active platelets."|on day 0 as a baseline and on day 7 and 21 of the study.||||percent||Standard Deviation|Mean
1424360|NCT01061034|Primary|Aspirin Level in Blood (Area Under the Curve)|"Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.~The area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin."|on day 7,on day 21|9 volunteers completed the study, one volunteer was excluded from pharmacokinetics, because serum salicylic acid concentration was not at the baseline (non-detectable) in the 0-hour sample.|||mg*hour/mL||Standard Deviation|Mean
1424361|NCT01061008|Secondary|Forearm Muscle Cross Sectional Area||3 months|||||||
1424362|NCT01061008|Secondary|Handgrip Endurance||3 months|||||||
1424363|NCT01061008|Secondary|Maximum Handgrip Strength||3 months|||||||
1424364|NCT01061008|Primary|Venous Diameter.|Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese & Nonnast-Daniel, 2004).|3 months||||mm||Standard Deviation|Mean
1424365|NCT01060670|Secondary|Change in Short Form Health Survey (SF-36) Quality of Life Metrics|Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.|Baseline and 16 weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1424366|NCT01060670|Secondary|Incidence of Ulcer Recurrence|Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.|12 weeks|ITT Population complete wound healed|||participants|||Number
1424367|NCT01060670|Secondary|Rate of Wound Closure|Rate of wound closure as assessed by computerized planimetry|16 weeks|ITT Population|||percentage wound closure/week||Standard Deviation|Mean
1424368|NCT01060670|Secondary|Time to Complete Wound Closure|Time to complete wound closure, as assessed by computerized planimetry.|16 weeks|ITT population complete wound healed with analyzable data|||days||Full Range|Median
1424369|NCT01060670|Secondary|Time to Complete Wound Closure|Measures the time to complete wound closure as assessed by the Investigator.|16 weeks|ITT Population complete wound healed with analyzable data|||days||Standard Deviation|Mean
1424370|NCT01060670|Secondary|Incidence of Complete Wound Closure|Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.|16 weeks|ITT Population|||percentage of subjects|||Number
1424371|NCT01060670|Primary|Incidence of Complete Wound Closure|100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.|16 weeks|The results were based on the Investigator assessment and ITT population.|||participants|||Number
1424372|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Small Bands Only)||12m post surgery||||%EWL||Standard Deviation|Mean
1424373|NCT01060592|Primary|% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)||12m post surgery||||%EWL||Standard Deviation|Mean
1424374|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)||4-6 weeks post surgery||||%EWL||Standard Deviation|Mean
1424375|NCT01060592|Secondary|Number of Band Adjustments Required in the First Year After Surgery||12 months||||Number of Adjustments||Standard Deviation|Mean
1424376|NCT01060592|Primary|%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)||4-6 weeks post surgery||||%EWL||Standard Deviation|Mean
1424377|NCT01060553|Secondary|Pittsburgh Sleep Index|subscales range from 0 to 3 with higher being worse.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis|||units on a scale||Standard Deviation|Mean
1424378|NCT01060553|Primary|SF-36|global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.|baseline, 6 or 12 weeks (latest available is used)|due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis.|||units on a scale||Standard Deviation|Mean
1424379|NCT01060540|Secondary|Moderate Intensity Physical Activity|self-report based on the long version of the International Physical Activity Questionnaire. Moderate physical activity was queried in the domains of work (e.g., carrying light loads), transportation (e.g., bicycling), domestic chores and gardening (e.g., sweeping, raking), and leisure-time (e.g., bicycling, swimming).|3 months||||minutes per week||Standard Deviation|Mean
1424380|NCT01060540|Secondary|Daily Caloric Intake|Estimated daily caloric intake based on self-reported frequency and amount of intake of specific foods over the past 3 months as assessed by the Block Brief Food Frequency Questionnaire|3 months||||kcal||Standard Deviation|Mean
1424381|NCT01060540|Secondary|Perceived Lifetime Risk of Type 2 Diabetes|measured on 1-7 scale (definitely will not get diabetes to definitely will get diabetes)|3 months||||units on a scale||Standard Deviation|Mean
1424384|NCT01060384|Secondary|Phase I and Phase II: Event Free Survival and Overall Survival|"Event free survival is defined as the time from start of treatment to disease progression or death from any cause. Overall survival (OS) is defined as the time from start of treatment to death from any cause. A response-evaluable subject will be considered anyone who completes at least 2 cycles of therapy with documented response or documented progression of disease after at least one complete cycle of therapy but, prior to 2 complete cycles of therapy.~A response-evaluable subject will be considered anyone who completes at least 2 cycles of therapy with documented response or documented progression of disease after at least one complete cycle of therapy but, prior to 2 complete cycles of therapy. A non-evaluable subject will be one who receives less than one complete cycle of therapy (ie. 4 infusions of ofatumumab and 21 days of lenalidomide). A non-evaluable subject will also be one that has no documented response prior to treatment withdrawal."|2 years from start of treatment|Six patients in Phase 1 were treated at the MTD and 34 patients enrolled in Phase II were eligible for evaluation. Data was analyzed for all patients treated at the MTD (n=40).|||percent of participants|||Number
1424385|NCT01060384|Primary|Phase I: Maximum Tolerated Dose (MTD) of Lenalidomide|The maximum tolerated dose (MTD) will be defined as the next lowest dose cohort below where ≥ 2/3 or ≥ 3/6 patients experience dose limiting toxicities in cycle 1.|7 months|Ten patients were enrolled in Phase 1. One patient was inevaluable, thus 9 patients are evaluable for outcome. Patients will be evaluable for Dose Limiting Toxicity (DLT) if they receive at least 75% of the planned doses of study drugs or they experience DLT in cycle 1 or and have sufficient followup data to determine whether DLT occurred.|||milligrams|||Number
1424386|NCT01060150|Secondary|Stroop Test Score for Ratio Interference|Ratio interference is calculated by dividing simple execution time by interfering execution time. The score range is 0-1. Higher value indicates better ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1424387|NCT01060150|Secondary|Stroop Test Result for False Reaction|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. The total value ranges from 0-24 errors for each execution where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Errors||Standard Deviation|Mean
1424388|NCT01060150|Secondary|Stroop Test Result for Reaction Time|This test consists of 3 trials: color trial (simple execution), word trial (middle execution) and word-color interference trial (interfering execution). In simple execution, participants have to read the written color names of the words independent of the color of the ink. In middle execution, participants have to read words written in black letters. In interfering experiment, participants have to say the color of the letters independent of the written word. This test estimates spending time for execution. High spending time indicates low ability of suppression of automation.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Seconds||Standard Deviation|Mean
1424389|NCT01060150|Secondary|Controlled Oral Words Association Test (COWAT) Score|This test measures the executive function of the frontal lobe and is consisted of examinations of category/meaning fluency and letter/phoneme fluency. It consisted of three 60 second word generation trials in which the participant orally generates as many words as possible that begin with target letters F, A and S. Dependent variables included total number of acceptable words generated for each target letter and total number of words generated across all three letter trials. Total score was calculated as sum of acceptable words generated, with higher scores indicating better verbal fluency.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Words||Standard Deviation|Mean
1424390|NCT01060150|Secondary|Finger Window (FW) Test Score|In FW test, a participant shows memory of a demonstrated visual pattern using a 8x11 inch plastic template containing 9 asymmetrically located holes. The examiner models a given sequence of holes and asks the participant to imitate the sequence by placing his/her finger through the same holes in the correct order. The total number of correct sequences constitutes the total score which ranges from 0-24 (forward FW) and 0-28 (backward FW) with higher score indicating a more favorable health state.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1424391|NCT01060150|Secondary|Digit Span Test Score|Each participant individually was given a sequence of numbers, with the sequence becoming progressively longer, to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. 1 point was awarded if the participant passed only 1 trial of a sequence length. 0 points were given if the participant failed both trials. Total score range was 0-16 (forwards) and 0-14 (backwards). A higher score was indicative of better recall and attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1428835|NCT01018511|Secondary|Minimum Concentration at Steady State (Cminss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1424392|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Score for Reaction Time and Response Variability|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/comission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The score range for both, reaction time and response variability, is 0-100. High score indicates worsening attention. If one or over factor’s score is over 65 point, the participant is resulted in having attention deficit.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on scale||Standard Deviation|Mean
1424393|NCT01060150|Secondary|Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnostic System (ADS) Test Result for Omission Errors and Commission Errors|The ADS is composed of 4 factors: omission/missing frequency to measure attention dispersibility; false alarm/commission frequency to measure impulse; mean response/reaction time to measure the speed of task processing; and the response variability/standard deviation of response time to measure the consistency of attention. The total value for both, omission errors and commission errors, ranges from 0-100 errors where high value indicates worsening attention.|Baseline and Week 12|The ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Errors||Standard Deviation|Mean
1424394|NCT01060150|Primary|Learning Skill Test (LST) Total Score|The LST measures learning ability of student. This scale is composed of 7 sections: self control, participation, task accomplishment, reading, writing, test taking and information processing. It consists of 70 items for middle school student (age 13-15 years) and 80 items for high school student (age 16-18 years). Each item is rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). The total score range is 70-350 for middle school version and 80-400 for high school version where higher score indicates better ability for learning. In result analysis, each sub-score and total score was converted to T-score for normalization. The score range of T-score is from 1 to 100 with a mean of 50. Higher score indicates better ability for learning.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||T-score||Standard Deviation|Mean
1424395|NCT01060150|Primary|Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Here 'N' (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1424396|NCT01060150|Primary|Clinical Global Impression - Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Week 12|ITT population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using LOCF.|||Units on a scale||Standard Deviation|Mean
1424397|NCT01060150|Primary|Korean Version of the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (K-ARS) Score|The K-ARS is a rating scale that is used for the ADHD diagnosis and the assessment of treatment efficacy and comprises 18 items in total on the basis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), each item being rated from 0-3 points. The total score ranges from 0-54 with 0=normal and 54=severe condition.|Week 12|Intent-to-treat (ITT) population included all participants who received the study drug at least once, satisfied the inclusion and exclusion criteria, and had efficacy assessment data at the Baseline. Missing values at Week 12 were imputed using Last observation carried forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1424398|NCT01060124|Other Pre-specified|Number of Participants With Investigator's Overall Evaluation on the Pain Treatment|Investigator assessed the participants for satisfaction on pain treatment after the administration of the TTS-fentanyl D-trans as very satisfied, satisfied, average, dissatisfied or very dissatisfied.|Day 29|Full Analysis (FAS) population included all those participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1424399|NCT01060124|Other Pre-specified|Initial and End Point Dose of TTS-Fentanyl D-trans|Dose of TTS-fentanyl D-trans were monitored at start and end of the trial.|Day 1 and Day 29|Safety population included all participants who were administered the TTS-fentanyl D-trans at least once.|||microgram per hour (mcg/hr)||Standard Deviation|Mean
1424400|NCT01060124|Other Pre-specified|Number of Participants With Detailed Reason for Satisfaction With the Pain Treatment|Participants were assessed for satisfaction for pain treatment after the administration of the TTS-fentanyl D-trans in detail with satisfied reasons, which are excellent pain relieving effect, convenient administration, minor adverse event, generally satisfied and other.|Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1424401|NCT01060124|Secondary|Difference in Pain Intensity Before and After Administration of (TTS)-Fentanyl D-trans|Pain intensity difference was measured by Visual Analog Scale (VAS) score, which ranges from 0 to 10 centimeter (cm) where 0 cm=no pain and 10 cm= unimaginably severe pain.|Day 1 and Day 29|Full Analysis (FAS) population included all participants who meet the inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
1440907|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 6|Month 6|Full Analysis Set - Participants with Observed Data|||mg/day||95% Confidence Interval|Mean
1424402|NCT01060124|Primary|Percentage of Participants Satisfied With Pain Treatment|Participants were assessed for their satisfaction for pain treatment after the application of the Transdermal Therapeutic System (TTS)-fentanyl D-trans.|Day 29|Per-Protocol (PP) analysis population included all participants who completed the clinical trial without violating the protocol among the participant who participated in the clinical trial.|||percentage of participants||95% Confidence Interval|Number
1424403|NCT01060111|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Week 6|VAS was used to measure the intensity of migraine. The assessment scale ranges from 0 to 10. One end of the line drawn on the questionnaire is marked with 0 point indicating “no headache” and the other end with 10 points indicating “unimaginably strong headache.” It means that the higher the score, the severe the pain is. Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a Scale||Standard Deviation|Mean
1424404|NCT01060111|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at Week 6|MIDAS scoring ranges from 0 to 63. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability). Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1424405|NCT01060111|Secondary|Change From Baseline in Migraine Frequency at Week 6|The migraine frequency at Week 6 was evaluated through a headache diary completed by a participant and the reduction rate of migraine frequency compared to the Baseline period was measured. Change values were calculated as Baseline value minus value at Week 6.|Baseline and Week 6|The ITT population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Migraine episodes/Week||Standard Deviation|Mean
1424406|NCT01060111|Primary|Percentage Decrease in Migraine Episodes|Decrease in percentage of migraine frequency (episodes) was measured from baseline using a headache diary which is a typical scale measuring neuropsychiatric symptoms in a migraine participant. Migraine will be diagnosed in accordance with the guidelines of the International Headache Society (IHS).|Maintenance period (Weeks 7 to 10)|The intent-to-treat (ITT) population included all the participants who took topiramate at least once and had migraine improvement data at the Week 6. Here 'N' signifies participants who were evaluated for this outcome measure.|||Percentage decrease in migraine episodes||Standard Deviation|Mean
1424407|NCT01060072|Secondary|Resolution of Anterior Chamber Flare|Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)|||participants|||Number
1424408|NCT01060072|Secondary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain|Visits 4-7 (Postoperative days 3-18)|Intention to treat population (ITT)|||participants|||Number
1424409|NCT01060072|Secondary|Resolution of Anterior Chamber Cells|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 4-7 (postoperative day 3-18)|Intention to treat population (ITT)|||participants|||Number
1424410|NCT01060072|Primary|Grade 0 Pain|Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population|||participants|||Number
1424411|NCT01060072|Primary|Resolution of Anterior Chamber Cells.|Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells|Visit 5 (Postoperative day 8)|Intention to treat (ITT) population|||participants|||Number
1424412|NCT01060059|Secondary|Factors of Higher Creatinine, Higher Fasting High Density Lipoprotein (HDL) Cholesterol, Higher Fasting Cholesterol, and Higher Fasting Triglycerides Which Were Associated With Treatment Choice at Baseline|Factors of higher creatinine: 1 milligram per deciliter higher (mg/dL) and higher fasting lipids (HDL cholesterol: 1 mg/dL higher; total cholesterol: 1 mg/dL higher; triglycerides: 1 mg/dL higher) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Creatinine and fasting lipids were measured in milligrams per deciliter (mg/dL).|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria. FASS=444 and 438 in each arm respectively but the number of patients with creatinine and fasting lipids data at baseline varied. N is presented with each category.|||mg/dL||Standard Deviation|Mean
1424413|NCT01060059|Secondary|Factor of Greater Height Associated With Treatment Choice at Baseline|Factor of greater height (1 centimeter higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Height was measured in centimeters (cm) .|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not provide height data so n=437."|||cm||Standard Deviation|Mean
1424414|NCT01060059|Secondary|Factor of Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline|Factor of higher body mass index (BMI) (1 kilogram per meter squared (kg/m^2) higher) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. BMI measured as kg/m^2.|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS for basal insulin arm=438 but one patient did not have data in this arm so n=437."|||kg/m^2||Standard Deviation|Mean
1424415|NCT01060059|Secondary|Factor of Older Age Associated With Treatment Choice at Baseline|Older age (1 year older) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Age was measured in years.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.|||years||Standard Deviation|Mean
1424416|NCT01060059|Secondary|Factor of Longer Duration of Diabetes Associated With Treatment Choice at Baseline|The Factor of longer duration of diabetes at baseline (diagnosed 1 year longer) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. Duration of diabetes was measured in years since the date of diabetes diagnosis.|baseline|Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.|||years||Standard Deviation|Mean
1424417|NCT01060059|Secondary|Factor of 1 Percent (%) Higher Baseline HbA1c Associated With Treatment Choice at Baseline|Factor of 1% higher baseline HbA1c (from most recent HbA1c) was analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor. HbA1c was measured as a percent of normal (%).|baseline|"Full analysis set (FAS) population: all patients who provided consent to release information and who fulfilled the study entry criteria.~FAS=444, however 1 patient in the exenatide arm was missing data for the most recent HbA1c at baseline so n=443."|||Percentage of normal||Standard Deviation|Mean
1424418|NCT01060059|Secondary|Factors of Gender, Baseline Presence of Medical Conditions, and Previous Gastrointestinal Symptoms Associated With Treatment Choice at Baseline|Number of patients per arm who were evaluated in 3 factors at baseline (gender, presence of medical conditions, and previous gastrointestinal symptoms) were analyzed for association with treatment choice at baseline. A total of 12 factors were evaluated. A multivariate logistic regression model using the full analysis set (FAS) population was performed for each of the factors to determine if exenatide treatment was more likely to be initiated in the presence of the specific factor.|baseline|All patients consented to release information; fulfilled study entry criteria. Analyses conducted on baseline arm assignment, irrespective of later treatment changes. Only those assigned to an arm were included. Missing values for numeric covariates replaced with means; categorical ones, with modes.|||participants|||Number
1424419|NCT01060059|Secondary|Percentage of Patients With Hypoglycemia Episodes Between Baseline and Month 12|"Percentage of patients with Hypoglycemia Episodes Between Baseline and Month 12.~All episodes consistent with hypoglycemia with or without a confirmatory blood glucose reading were collected."|Baseline to Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
1424420|NCT01060059|Secondary|Changes in Systolic Blood Pressure Between Baseline and Month 12|Changes in Systolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mmHg||Standard Deviation|Mean
1424421|NCT01060059|Secondary|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Changes in Diastolic Blood Pressure Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mmHg||Standard Deviation|Mean
1424422|NCT01060059|Secondary|Changes in Fasting Triglycerides Between Baseline and Month 12|Changes in Fasting Triglycerides Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
1424423|NCT01060059|Secondary|Changes in Fasting LDL Between Baseline and Month 12|Changes in Fasting LDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
1424424|NCT01060059|Secondary|Changes in Fasting HDL Between Baseline and Month 12|Changes in Fasting HDL Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
1424425|NCT01060059|Secondary|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Changes in Fasting Total Cholesterol Between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||mg/dL||Standard Deviation|Mean
1424446|NCT01060007|Secondary|Incidence of Any Late Grade 3 or Higher Morbidity||Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.|||participants|||Number
1424426|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=5% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=5% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
1424427|NCT01060059|Secondary|Percentage of Patients Achieving a Weight Decrease >=3% Between Baseline and Month 12|Percentage of Patients Achieving a Weight Decrease >=3% between Baseline and Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
1424428|NCT01060059|Secondary|Changes in Weight From Baseline to Month 12|Changes in Weight From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||kg||Standard Deviation|Mean
1424429|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
1424430|NCT01060059|Secondary|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Percentage of Patients Achieving HbA1c Concentration <=7.0% at Month 12|Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
1424431|NCT01060059|Secondary|Percentage of Patients With HbA1c Reduction From Baseline >= 1.0% at Month 12|Percentage of Patients with HbA1c Reduction from Baseline >= 1.0% at Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes"|||percentage of patients|||Number
1424432|NCT01060059|Secondary|Changes in Fasting Blood Glucose From Baseline to Month 12|Changes in Fasting Blood Glucose From Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."|||mg/dL||Standard Deviation|Mean
1424433|NCT01060059|Secondary|Changes in HbA1c From Baseline to Month 12|Changes in HbA1c from Baseline to Month 12|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."|||percent||Standard Deviation|Mean
1424434|NCT01060059|Primary|Percentage of Patients Who Achieved Glycemic Target of HbA1c ≤ 7.0% With Minimal Weight Gain (≤ 1 Kg) at Month 12.|Percentage of patients who achieved glycemic target of HbA1c ≤ 7.0% with minimal weight gain (≤ 1 Kg) at month 12.|Baseline, Month 12|"All patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses.~Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes."|||percentage of patients||95% Confidence Interval|Number
1424435|NCT01060020|Secondary|Global Longitudinal Strain|Global longitudinal strain was measured at baseline and 60 minutes after drug administration.|Baseline and 60 minutes after drug administered||||percent||Standard Deviation|Mean
1424436|NCT01060020|Secondary|Load Independent Index of Diastolic Filling.|Measurements of the load independent index of diastolic filling were made with the parameterized diastolic filling formalism as previously described and validated with the use of transmitral Doppler E waves recorded during different respiratory states (regular breathing and held expiration and inspiration).|Baseline and 60 minutes after drug administered||||unitless||Standard Deviation|Mean
1424437|NCT01060020|Secondary|Percent Change in Cardiac Index.|Cardiac index is cardiac output divided by body surface area.|Baseline and 60 minutes after drug administered||||percent change||Inter-Quartile Range|Median
1424438|NCT01060020|Secondary|Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.||Baseline and 60 minutes after drug administered||||percent change||Inter-Quartile Range|Median
1424439|NCT01060020|Primary|Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.||Baseline and 60 minutes after drug administered||||percent change||Inter-Quartile Range|Median
1424440|NCT01060007|Secondary|Determine Quality of Anorectal Function|"Anorectal function was measured by the participant's response to the FACT-C questionnaire question I have control of my bowels. The answers ranged from 0=not at all to 4=very much."|Up to 1 year|Participants who had an ostomy were not included in this outcome measure. Participants who did not complete FACT-C questionnaire at a specific timepoint were not included in that timepoint.|||Participants|||Count of Participants
1424441|NCT01060007|Secondary|Freedom From Disease Relapse|Kaplan-Meier projections.|30 months|These include all cMO evaluable cases only.|||percentage of participants||95% Confidence Interval|Number
1424442|NCT01060007|Secondary|Rate of Locoregional Control||1 year||||percentage of participants|||Number
1424443|NCT01060007|Secondary|Rate of Overall Control||1 year||||percentage of participants|||Number
1424444|NCT01060007|Secondary|Local Control|"Kaplan-Meier projections~Local control = control of primary tumor"|30 months||||percentage of participants||95% Confidence Interval|Number
1424447|NCT01060007|Primary|Preoperative Gastrointestinal Morbidity|As measured by participants who experience grade 3 or higher gastrointestinal morbidity|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)|One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy.|||participants|||Number
1424448|NCT01060007|Primary|Rate of T Stage Downstaging|T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).|Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)||||percentage of participants|||Number
1424449|NCT01059994|Secondary|Protein Synthesis|Skeletal muscle protein synthesis, measured as the fractional synthesis rate (the percent of the total synthesized per unit time)|2 weeks||||% synthesized of total/hour||Standard Deviation|Mean
1424450|NCT01059994|Primary|Muscle Fatigue|successful isokinetic knee extension repetitions, % baseline day repetitions|2 weeks||||successful repetitions (% baseline day)||Standard Deviation|Mean
1424451|NCT01059929|Secondary|Number of Adverse Medication Effects||duration of infusion of study medication up to 28 days||||number of events|||Number
1424452|NCT01059929|Secondary|Number of Patients Completing Activities of Daily Living|activities of daily living: eating, bathing, dressing, grooming, toileting|daily through day 28||||Participants|||Count of Participants
1424453|NCT01059929|Secondary|Days in Hospital||60 days from enrollment||||days||Inter-Quartile Range|Median
1424454|NCT01059929|Secondary|Number of Patients Requiring Midazolam||during infusion of study medication through day 28||||Participants|||Count of Participants
1424455|NCT01059929|Secondary|Number of Patients Requiring Fentanyl||during infusion of study medication up to day 28||||Participants|||Count of Participants
1424456|NCT01059929|Secondary|Number of Participants With ICU Complications||daily through day 28||||Participants|||Count of Participants
1424457|NCT01059929|Secondary|Mortality||28 days from enrollment||||Participants|||Count of Participants
1424458|NCT01059929|Secondary|Days in ICU||60 days from enollment||||days||Inter-Quartile Range|Median
1424459|NCT01059929|Secondary|Days on Ventilator||60 days from enrollment||||days||Inter-Quartile Range|Median
1424460|NCT01059929|Secondary|Number of Patients Completing Mobility Milestones|Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently|Daily through day 28||||Participants|||Count of Participants
1424461|NCT01059929|Secondary|Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score|Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided.|Daily up to day 28||||score on a scale||Inter-Quartile Range|Median
1424462|NCT01059929|Primary|Proportion of Days With Delirium|delirium assessment using CAM-ICU|daily up to 28 days|Study terminated early due to inability to maintain study drug supply in investigational pharmacy.|||proportion of days||Inter-Quartile Range|Median
1424463|NCT01059903|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.|24 hours|Pharmacokinetic Set (PKS)|||mg||Standard Deviation|Mean
1424464|NCT01059903|Secondary|Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine|The CL/f of unconjugated rotigotine is the apparent total body clearance.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||L/ h||Standard Deviation|Mean
1424465|NCT01059903|Secondary|Terminal Half-Life (t1/2) of Unconjugated Rotigotine|the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||hours (h)||Standard Deviation|Mean
1424466|NCT01059903|Secondary|Rate Constant of Elimination (λz) of Unconjugated Rotigotine|The λz of unconjugated rotigotine is the rate constant of elimination.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||1/ h||Standard Deviation|Mean
1424467|NCT01059903|Secondary|Mean Residence Time (MRT) of Unconjugated Rotigotine|The MRT is the mean residence time.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||hours (h)||Standard Deviation|Mean
1424468|NCT01059903|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach maximum plasma concentration after patch application.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||hours (h)||Standard Deviation|Mean
1424469|NCT01059903|Secondary|Cmax, Norm (Body Weight) of Unconjugated Rotigotine|The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*kg||Standard Deviation|Mean
1424470|NCT01059903|Secondary|Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL/ mg||Standard Deviation|Mean
1424471|NCT01059903|Secondary|AUC(0- ∞) Norm (Body Weight)|The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng*h*kg/ mL||Standard Deviation|Mean
1424552|NCT01059760|Primary|Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed||Baseline and 3 days||||mmHg||Standard Deviation|Mean
1424472|NCT01059903|Secondary|AUC(0- ∞) Norm (Apparent Dose)|The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h/ mg||Standard Deviation|Mean
1424473|NCT01059903|Secondary|AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng*h*kg/ mL||Standard Deviation|Mean
1424474|NCT01059903|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h/ mg||Standard Deviation|Mean
1424475|NCT01059903|Primary|AUC(0- ∞) of Unconjugated Rotigotine|The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h||Standard Deviation|Mean
1424476|NCT01059903|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL||Standard Deviation|Mean
1424477|NCT01059903|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration.|0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h|Pharmacokinetic Set (PKS)|||ng/ mL*h||Standard Deviation|Mean
1424478|NCT01059864|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||units on a scale||Standard Deviation|Mean
1424479|NCT01059864|Secondary|Patient's Global Assessment (PtGA) of Arthritis Pain|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain."|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm||Standard Deviation|Mean
1424480|NCT01059864|Secondary|Physician's Global Assessment (PhysGA) of Arthritis Pain|The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient’s global assessment of arthritis. Physician’s response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm||Standard Deviation|Mean
1424481|NCT01059864|Secondary|Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm||Standard Deviation|Mean
1424482|NCT01059864|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mm/hr||Standard Deviation|Mean
1424483|NCT01059864|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mg/L||Standard Deviation|Mean
1424484|NCT01059864|Secondary|Swollen-Joint Count|Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||swollen joints||Standard Deviation|Mean
1424485|NCT01059864|Secondary|Tender-Joint Count|Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint’s response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||tender joints||Standard Deviation|Mean
1424553|NCT01059760|Primary|Change From Baseline in Participant Waist Circumference When Fasting and Fed||Baseline and 3 days||||cm||Standard Deviation|Mean
1424486|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||percentage of participants|||Number
1424487|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||percentage of participants|||Number
1424488|NCT01059864|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||percentage of participants|||Number
1424489|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) [mm/hr] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) <=3.2 indicated low disease activity, DAS28-4 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1424490|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). DAS28-3 (ESR) <=3.2 indicated low disease activity, DAS28-3 (ESR) >3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-3(ESR) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.||||||
1424491|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) [mg/L] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 [CRP] <=3.2 indicated low disease activity, DAS28-4 [CRP] >3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.|Day 0, Week 6 (Baseline), 12|Since DAS28-3(CRP) and DAS28-4(ESR) are summarized, data for DAS28-4(CRP) was collected and reported in individual participant listings, but not statistically summarized for analysis as planned.||||||
1424492|NCT01059864|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter [mg/L]). DAS28-3 (CRP) less than or equal to (<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (>) 3.2 to 5.1 indicated moderate to high disease activity.|Day 0, Week 6 (Baseline), 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||units on a scale||Standard Deviation|Mean
1424493|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||micromole per liter (mcmol/L)||Standard Deviation|Mean
1424494|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
1424495|NCT01059864|Secondary|12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||nanometer (nm)||Standard Deviation|Mean
1424496|NCT01059864|Secondary|12-Hours Fasting Lipid Profile|Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.|Day 0, Week 2, 6 (Baseline), 10, 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo).|||mg/dL||Standard Deviation|Mean
1424497|NCT01059864|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline (Week 6), Week 12|FAS population included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
1424498|NCT01059864|Primary|Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12||Baseline (Week 6), Week 12|Full analysis set (FAS) included all participants who were randomized to the study treatment groups and received at least one dose of the randomized investigational drug (atorvastatin or placebo). Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Error|Least Squares Mean
1424499|NCT01059851|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
1424500|NCT01059851|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
1424501|NCT01059851|Primary|AUC(0-∞) After Single Dose Suvorexant: Moderate and Mild Renal Impairment Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|Per protocol, the decision to conduct Part II of study in moderate/mild renal impairment participants was conditional on results of AUC (0-∞) analysis in severe renal impairment participants (Part I). Based on results of Part I of study, Part II was not conducted and AUC(0-∞) analysis in moderate/mild renal impairment was not done.||||||
1424502|NCT01059851|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Severe Renal Impairment Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and the extrapolated area given by the quotient of the last detectable concentration and the apparent terminal rate constant (λ).|Predose and 0.5, 1, 2, 4, 6, 9, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|All Treated Participants|||μM•hr||95% Confidence Interval|Geometric Mean
1424503|NCT01059825|Secondary|Number of Participants Who Discontinued Study Medication Due to an AE|An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin and excludes a temporary discontinuation of study medication.|Up to 84 days|All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).|||Participants|||Number
1424504|NCT01059825|Secondary|Number of Participants Who Experienced an Advere Event (AE)|An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.|Up to 98 days|All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).|||Participants|||Number
1424505|NCT01059825|Secondary|Percentage of Participants Achieving HbA1C <6.5% at Week 12|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Week 12|Analysis population excludes participants with missing Week 12 HbA1c measurement.|||Percentage of participants|||Number
1424506|NCT01059825|Secondary|Percentage of Participants Achieving HbA1c <7% at Week 12|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Week 12|Analysis population excludes participants with missing Week 12 HbA1c measurement.|||Percentage of participants|||Number
1424507|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 8|The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 8.|||mg/dL||80% Confidence Interval|Least Squares Mean
1424508|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 4|The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 4.|||mg/dL||80% Confidence Interval|Least Squares Mean
1424509|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 2|The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 2.|||mg/dL||80% Confidence Interval|Least Squares Mean
1424510|NCT01059825|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 12.|||mg/dL||80% Confidence Interval|Least Squares Mean
1424511|NCT01059825|Secondary|Baseline Fasting Plasma Glucose|Laboratory measurements were performed after an overnight fast ≥8 hours in duration.|Baseline|All randomized participants.|||mg/dL||Standard Error|Mean
1424512|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 8.|||mmHg||80% Confidence Interval|Least Squares Mean
1424513|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 4|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 4.|||mmHg||80% Confidence Interval|Least Squares Mean
1424514|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 2|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 2.|||mmHg||80% Confidence Interval|Least Squares Mean
1424515|NCT01059825|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 12|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 12.|||mmHg||80% Confidence Interval|Least Squares Mean
1424516|NCT01059825|Secondary|Baseline Diastolic Blood Pressure|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.|Baseline|All randomized participants.|||mmHg||Standard Error|Mean
1424517|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 8.|||mmHg||80% Confidence Interval|Least Squares Mean
1424518|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 4|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 4.|||mmHg||80% Confidence Interval|Least Squares Mean
1424519|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 2|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 2.|||mmHg||80% Confidence Interval|Least Squares Mean
1424520|NCT01059825|Secondary|Change From Baseline in Systolic Blood Pressure at Week 12|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 12.|||mmHg||80% Confidence Interval|Least Squares Mean
1424521|NCT01059825|Secondary|Baseline Systolic Blood Pressure|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.|Baseline|All randomized participants.|||mmHg||Standard Error|Mean
1424522|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 8|The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 8.|||Percent change||80% Confidence Interval|Least Squares Mean
1424523|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 4|The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 4.|||Percent change||80% Confidence Interval|Least Squares Mean
1424554|NCT01059760|Primary|Change From Baseline in Participant Weight When Fasting and Fed||Baseline and 3 days||||kg||Standard Deviation|Mean
1424555|NCT01059760|Primary|Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed||Baseline and 3 days||||ratio||Standard Deviation|Mean
1424524|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 2|The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 2.|||Percent change||80% Confidence Interval|Least Squares Mean
1424525|NCT01059825|Secondary|Percent Change From Baseline in Body Weight at Week 12|The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 12.|||Percent change||80% Confidence Interval|Least Squares Mean
1424526|NCT01059825|Secondary|Baseline Body Weight||Baseline|All randomized participants.|||kg||Standard Error|Mean
1424527|NCT01059825|Secondary|Change From Baseline in HbA1c at Week 8|HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 8|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 8.|||Percent||80% Confidence Interval|Least Squares Mean
1424528|NCT01059825|Secondary|Change From Baseline in HbA1c at Week 4|HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 4|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 4.|||Percent||80% Confidence Interval|Least Squares Mean
1424529|NCT01059825|Secondary|Change From Baseline in HbA1C at Week 2|HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).|Baseline and Week 2|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 2.|||Percent||80% Confidence Interval|Least Squares Mean
1424530|NCT01059825|Primary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).|Baseline and Week 12|Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 12.|||Percent||80% Confidence Interval|Least Squares Mean
1424531|NCT01059825|Primary|Baseline Hemoglobin A1c (HbA1c)|HbA1c is measured as percent.|Baseline|All randomized participants.|||Percent||Standard Error|Mean
1424532|NCT01059812|Secondary|Change in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, Week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||kg||Standard Deviation|Mean
1424533|NCT01059812|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1424534|NCT01059812|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1424535|NCT01059812|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 24 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1424536|NCT01059812|Primary|Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1424537|NCT01059799|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects.The missing data is imputed using last observation carried forward (LOCF). For 25 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1424538|NCT01059799|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1424556|NCT01059760|Primary|Change From Baseline in Participant Triglycerides When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1424539|NCT01059799|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1424540|NCT01059799|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1424541|NCT01059773|Secondary|Proportion of Patients Achieving PASI 90 Response|This is based on the number of participants achieving at least 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.|||Percentage of participants||95% Confidence Interval|Number
1424542|NCT01059773|Secondary|Proportion of Patients Achieving PASI 75 Response|This is based on the number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.|||Percentage of participants||95% Confidence Interval|Number
1424543|NCT01059773|Secondary|Proportion of Patients Achieving PASI 50 Response|This is based on the number of participants achieving at least 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.|||Percentage of participants||95% Confidence Interval|Number
1424544|NCT01059773|Secondary|Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline|Change from baseline in Psoriasis Area and Severity Index (PASI) (0 [best] - 72 [worst]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.|at Weeks 0, 2, 4, 12, 16, 28, 40 and 52|The modified intent-to-treat (mITT) analysis includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis|||Units on a scale||Standard Deviation|Mean
1424545|NCT01059773|Secondary|Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)|The number of patients with a malignancy and other event of clinical interest (tuberculosis, serious cardiovascular events, anaphylactic/serum sickness reaction) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg)|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information|||Number of patients|||Number
1424546|NCT01059773|Secondary|Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): infections, serious infections, and infections requiring oral or parenteral antimicrobial treatment (infections being considered any event that by the investigator was indicated as infection on the CRF).|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information|||Number of patients|||Number
1424547|NCT01059773|Primary|Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12||from week 0 to week 12|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.|||participants|||Number
1424548|NCT01059773|Secondary|Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period|The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE with severe intensity; AE or SAE reasonably related to ustekinumab (i.e., AEs classified by the investigator as ‘possibly’, ‘probably’, or ‘very likely’ related to study agent); AE or SAE leading to permanent discontinuation of ustekinumab.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information|||Number of patients|||Number
1424549|NCT01059773|Secondary|Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period|The number of patients with any of the following Treatment Emergent AEs (TEAEs) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and >100 kg): AE; SAE and Death.|at week 12, 16, 28 40 and 52|All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.|||Number of patients|||Number
1424550|NCT01059760|Primary|Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed||Baseline and 3 days||||mg/L||Standard Error|Median
1424551|NCT01059760|Primary|Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed||Baseline and 3 days||||mmHg||Standard Deviation|Mean
1424580|NCT01059760|Primary|Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed|HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance|Baseline and 3 days||||units on a scale||Standard Deviation|Mean
1424581|NCT01059760|Primary|Change From Baseline in Participant Insulin When Fasting and Fed||Baseline and 3 days||||mU/L||Standard Deviation|Mean
1424582|NCT01059760|Primary|Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed||Baseline and 3 days||||ng/mL||Standard Deviation|Mean
1424583|NCT01059760|Primary|Change From Baseline in Participant Glucose When Fasting and Fed||Baseline and 3 days||||mg/dL||Standard Deviation|Mean
1424584|NCT01059643|Other Pre-specified|Number of Participants Who Died Due to Unknown Causes During the 30-Day Post-Study Treatment Follow-Up||End of study treatment up to 30-days post-study treatment discontinuation|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1424585|NCT01059643|Secondary|Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355|Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level.|Day 1 and Day 3 of Cycle 1 (21-day cycle)|All enrolled participants who received at least 1 dose of study drug with Ra measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1424586|NCT01059643|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307|Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).|Day 3 of Cycle 1 (21-day cycle)|All enrolled participants who received at least 1 dose of study drug with Cmax measure.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1424587|NCT01059643|Secondary|Change in Tumor Size at Smallest Size (Best Response)|The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.|Baseline until cycle with maximum change from baseline up to 36 weeks|All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response.|||percentage of change||Standard Deviation|Mean
1424588|NCT01059643|Secondary|Tumor Marker Values as Relevant to Specific Tumor Types at Baseline|The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).|Baseline|All enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1424589|NCT01059643|Secondary|Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.|Baseline until progressive disease up to 36 weeks post-baseline|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
1424590|NCT01059643|Secondary|Progression Free Survival (PFS)|PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.|Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment|All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%.|||months||90% Confidence Interval|Median
1424591|NCT01059643|Primary|Percentage of Participants With a Complete Response (CR) or Partial Response (PR)|The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline until progressive disease up to 36 weeks post-baseline|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
1424954|NCT01056107|Secondary|Ascending Colon Emptying Half-time (AC t1/2) Measured by Scintigraphy|Ascending colon emptying half-time will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.|48 hours (Visit 4 = Day 2)|Intent-to-treat|||hours||Standard Error|Mean
1424592|NCT01059630|Secondary|Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores|FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0−116). FACT-Lym total score is sum of 42 items (total score ranges from 0−168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).|Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), and 12 (FUM12)|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified category.|||Percentage of participants|||Number
1424593|NCT01059630|Secondary|Time to Deterioration of FACT-Lym TOI|The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline up to approximately 4 years (Baseline, Day 1 of Cycles 1, 3, 4, 5, EOI treatment [up to Month 6]; Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up [up to 2 years after EOI]; Extension follow-up Months 6 and 18)|ITT population.|||Months||95% Confidence Interval|Median
1424594|NCT01059630|Secondary|CFB in FACT-Lym Total Score|FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0−168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||Units on a scale||Standard Deviation|Mean
1424595|NCT01059630|Secondary|CFB in FACT-Lym Trial Outcome Index (TOI)|TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0−116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||Units on a scale||Standard Deviation|Mean
1424596|NCT01059630|Secondary|CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score|The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, “Not at all” to 4, “Very much”. Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||Units on a scale||Standard Deviation|Mean
1424597|NCT01059630|Secondary|CFB in EQ-5D VAS Score During Maintenance Phase|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for ‘Obinutuzumab + Bendamustine’ arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424955|NCT01056107|Secondary|Colonic Filling at 6 h Measured by Scintigraphy|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours (Visit 2 = Day 0)|Intent-to-treat|||percentage of meal||Standard Error|Mean
1439465|NCT00939211|Primary|Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose|Maximum FEV1 value|0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h||||L||Standard Deviation|Mean
1424598|NCT01059630|Secondary|CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For ‘Obinutuzumab + Bendamustine’ arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under “CFB at Follow-up Month 2” and “CFB at Follow-up Month 4” categories.|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2 and 4|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424599|NCT01059630|Secondary|CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for ‘Obinutuzumab + Bendamustine’ arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase."|Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)|ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424600|NCT01059630|Secondary|CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For ‘Obinutuzumab + Bendamustine’ arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under “CFB at Follow-up Month 2” and “CFB at Follow-up Month 4” categories."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, and 4|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424601|NCT01059630|Secondary|CFB in FACT-Lym-Lymphoma Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424602|NCT01059630|Secondary|CFB in FACT-Lym-Functional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424603|NCT01059630|Secondary|CFB in FACT-Lym-Emotional Well-Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424604|NCT01059630|Secondary|CFB in FACT-Lym-Social/Family Well-being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424605|NCT01059630|Secondary|Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score|"The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up)."|Baseline, Day 1 of Cycles 1, 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6 and 18|ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point.|||units on a scale||Standard Deviation|Mean
1424606|NCT01059630|Secondary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until death (up to 4.5 years overall)|ITT population.|||months||95% Confidence Interval|Median
1424607|NCT01059630|Secondary|Percentage of Participants Who Died||Baseline until death (up to 4.5 years overall)|ITT population.|||percentage of participants|||Number
1424608|NCT01059630|Secondary|Event-free Survival (EFS) as Assessed by IRC|EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.|||months||95% Confidence Interval|Median
1424609|NCT01059630|Secondary|Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC|DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.|||months||95% Confidence Interval|Median
1424610|NCT01059630|Secondary|Duration of Response (DoR) as Assessed by IRC|DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.|||months||95% Confidence Interval|Median
1424624|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424611|NCT01059630|Secondary|Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC and Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.|||percentage of participants||95% Confidence Interval|Number
1424612|NCT01059630|Secondary|Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC and Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1)|ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.|||percentage of participants||95% Confidence Interval|Number
1424613|NCT01059630|Secondary|Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC and Investigator|BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 12 months overall)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1424614|NCT01059630|Secondary|Percentage of Participants With Objective Response as Assessed by IRC and Investigator|Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 12 months overall)|ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
1424615|NCT01059630|Secondary|PFS as Assessed by Investigator|PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.|||months||95% Confidence Interval|Median
1424689|NCT01059175|Secondary|Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire|Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.|24 months|Number of patients with data available for analysis of this objective|||units on a scale||Standard Deviation|Mean
1424690|NCT01059175|Secondary|Changes in Echocardiographic Indexes of Left Ventricle Remodeling|Changes between baseline and 24months follow up|24 months|Number of patients with data available for analysis of this objective|||milliliter||Standard Deviation|Mean
1424691|NCT01059175|Secondary|Overall Mortality||24 months||||participants|||Number
1424616|NCT01059630|Secondary|Number of Participants With PD or Death as Assessed by Investigator|PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.|||participants|||Number
1424617|NCT01059630|Primary|Progression-Free Survival (PFS) as Assessed by IRC|PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.|||months||95% Confidence Interval|Median
1424618|NCT01059630|Primary|Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death|PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis.|Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28−42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])|ITT population.|||participants|||Number
1424619|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
1424620|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424621|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
1424622|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.~Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424623|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122, 129, 136, 143, 150, 157 and 164.|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
1424625|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
1424626|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.~Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14 and 21 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine."|Before vaccination and at Days 7, 14, 21 and 122|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424627|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), creatinine (CREA), blood urea nitrogen (BUN), and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|"The Total Vaccinated cohort included all vaccinated subjects for whom data were available~N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here."|||Subjects|||Number
1424628|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|At Day 304|"The Total Vaccinated cohort included all vaccinated subjects for whom data were available.~N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here."|||Subjects|||Number
1424629|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.|"Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatise (AP), creatinine (CREA), blood urea nitrogen (BUN) and bilirubin (BIL) (total (T) and direct (D)).~For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated)."|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424630|NCT01059617|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.|Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).|On Days 0, 21, 122 and 164|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1424631|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.|"Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.~Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424632|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group|"Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.~Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424692|NCT01059175|Secondary|Time to First Heart Failure Related Hospitalization||24 months||||days||Standard Error|Mean
1424693|NCT01059175|Secondary|Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study||24 months||||participants|||Number
1439466|NCT00939198|Secondary|Anti-Na-ASP-2 IgE Antibody Level on Day of Skin Test Reaction||Upon skin testing||||kU/L||Inter-Quartile Range|Median
1424633|NCT01059617|Secondary|Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.|"Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).~Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424634|NCT01059617|Secondary|Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.|"Solicited local symptoms assessed were pain, redness and swelling and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo).~Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm)."|During the 7-day (Days 0-6) follow-up period after vaccination.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424635|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424636|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|Within Days 0-233|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424637|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination. Missing values will be added once they become available.|Up to Day 234|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424638|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).||||Subjects|||Number
1424639|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"Unsolicited AEs were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.~An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms."|Within 84 days following first dose or 63 days following second dose of vaccine.|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424640|NCT01059617|Secondary|Number of Subjects Reporting Unsolicited AEs.|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Unsolicited AEs were collected after the administration of the Flulaval vaccine or the placebo dose and the data has been pooled based on the vaccination received at Day 0."|Up to 21-day (Days 0-20) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1424641|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).|MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).||||Subjects|||Number
1424642|NCT01059617|Secondary|Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (up to Day 507).||||Subjects|||Number
1424643|NCT01059617|Secondary|Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens|CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin2, Tumor Necrosis Factor alpha or Interferongamma. The frequency was presented as number of cytokineproducing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.|After the administration of Arepanrix vaccine (Day 125 to 304)|The According-To-Protocol cohort for immunogenicity at Day 304 included all evaluable subjects who had not received a vaccine not specified or forbidden in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken at Day 304.|||cells/million T cells||Inter-Quartile Range|Median
1424644|NCT01059617|Secondary|Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens|"CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.~The frequency was presented as number of cytokine-producing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.~Subjects with missing results were not included."|Before administration of Arepanrix vaccine (Day 0 to Day 122)|The ATP cohort for immunogenicity at Day 164 included subjects who received protocol specified vaccine(s) during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after second H1N1 vaccine dose (Day 164). Subjects with missing results were not included.|||cells/million T cells||Inter-Quartile Range|Median
1424645|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|For the entire study period up to Day 507|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.|||Subjects|||Number
1424646|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 0 and Day 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Titers||95% Confidence Interval|Geometric Mean
1424647|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Days 0 and 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Subjects|||Number
1424648|NCT01059617|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|Entire study period up to Day 507|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.|||Subjects|||Number
1424649|NCT01059617|Secondary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Days 122 and 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Titers||95% Confidence Interval|Geometric Mean
1424650|NCT01059617|Secondary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|At Day 122 and Day 304|The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.|||Subjects|||Number
1424651|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424652|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
1424653|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424654|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Fold increase||95% Confidence Interval|Geometric Mean
1424655|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424656|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424657|NCT01059617|Primary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424658|NCT01059617|Primary|Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Titers||95% Confidence Interval|Geometric Mean
1424659|NCT01059617|Primary|Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424660|NCT01059617|Primary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Geometric mean fold-rise (GMFR), or seronversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Fold||95% Confidence Interval|Geometric Mean
1424661|NCT01059617|Primary|Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424694|NCT01059175|Secondary|Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study|Changes between baseline and 24months follow up|24 months||||meters||Standard Deviation|Mean
1424695|NCT01059175|Secondary|Rate of Adverse Events||24 months||||participants|||Number
1424995|NCT01055457|Primary|Distance Visual Acuity (LogMAR)|Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.|Up to 3 Months Post Lens Wear|All subjects that completed the study.|||LogMAR|Subjects Eyes|Standard Deviation|Mean
1424662|NCT01059617|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.|Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).|The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).|||Subjects|||Number
1424663|NCT01059565|Secondary|Percentage of Missed School or Work Days|The percentage of days participants missed school or work from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of days||Standard Deviation|Mean
1424664|NCT01059565|Secondary|Percent of Days Hospitalized|The percentage of days hospitalized from baseline to Week 24 was analyzed.|Baseline to Week 24|Full Analysis Set|||percentage of days||Standard Deviation|Mean
1424665|NCT01059565|Secondary|Percentage of Days Participants Used Antibiotics|The percentage of days participants used antibiotics from baseline to Week 24 was analyzed. Antibiotics ongoing at baseline or started on or after first dose date were included in the analysis. A single antibiotic course could represent the use of multiple antibiotics. Days of antibiotic use included unique days.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of days||Standard Deviation|Mean
1424666|NCT01059565|Secondary|Change in Burkholderia Spp. CFU in Sputum From Baseline to Week 24|The change in Burkholderia spp. CFU in sputum from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||log_10 CFU per gram of sputum||Standard Error|Least Squares Mean
1424667|NCT01059565|Secondary|Change in BMI From Baseline to Week 24|The change in BMI from baseline to Week 24 was analyzed.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||kg/m^2||Standard Error|Least Squares Mean
1424668|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Treatment Burden Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the treatment burden score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R treatment burden domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1424669|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Weight Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the weight score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R weight domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1424670|NCT01059565|Secondary|AUCave of the Change From Baseline to Week 24 in Physical Functioning Score as Assessed by the CFQ-R|"The change (AUCave) from baseline to Week 24 in the physical functioning score as assessed by the CFQ-R was analyzed.~The range of scores (units) in the CFQ-R physical functioning domain is 0 to 100 with higher scores indicating better QOL."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1424671|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEF25-75|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEF25-75 was analyzed. FEF25-75 is defined as the forced expiratory flow from 25% to 75% of the FVC.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||percent change in FEF25-75 (liters/sec)||Standard Error|Least Squares Mean
1424672|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FVC|The relative change (AUCave) from baseline to Week 24 in mean (SE) FVC was analyzed. FVC is defined as the volume of air that can forcibly be blown out after taking a full breath.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||percent change in FVC (liters)||Standard Error|Least Squares Mean
1424673|NCT01059565|Secondary|AUCave of Relative Change From Baseline to Week 24 in FEV1|The relative change (AUCave) from baseline to Week 24 in mean (SE) FEV1 was analyzed. FEV1 is defined as the maximal volume of air that can be exhaled in 1 second.|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||percent change in FEV1 (liters)||Standard Error|Least Squares Mean
1424674|NCT01059565|Secondary|AUCave of Change in CFQ-R RSS Scores From Baseline to Week 24|"The change (AUCave) in CFQ-R RSS scores from baseline to Week 24 was analyzed.~The range of scores (units) within the RSS domain is 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Week 24|Participants in the Full Analysis Set with available change data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1424675|NCT01059565|Secondary|Total Number of Systemic and/or Inhaled Antibiotic Courses for Respiratory Events|The total number of systemic and/or inhaled antibiotic courses for respiratory events from baseline to Week 24 was analyzed. A single antibiotic course may represent the use of multiple antibiotics.|Baseline to Week 24|Full Analysis Set|||antibiotic treatment courses|||Number
1424676|NCT01059565|Primary|AUCave of Relative Change in FEV1 % Predicted From Baseline to Week 24|The relative change (AUCave) in FEV1 % predicted from baseline to Week 24 was analyzed. FEV1 % predicted is defined as FEV1 % of the patient divided by the average FEV1 % in the population for any person of similar age, sex and body composition. AUCave is the calculated area under the curve corrected for baseline and adjusted by the number of days on study through Week 24.|Baseline to Week 24|Full Analysis Set|||percent change in FEV1% predicted||Standard Error|Least Squares Mean
1424729|NCT01058356|Primary|Presence of AAD|AAD defined as: Watery stools more than 3 times per day for at least 2 days.|Up to 14 days||||participants|||Number
1425066|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 27|The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
1424677|NCT01059526|Secondary|Overall Patient Response Assessment|The Overall Response Assessment was to be completed every 30 minutes after treatment until patient discharge. Patients evaluated their response to treatment as “a lot better or resolved,” “a little better,” “the same,” “a little worse,” or “a lot worse.” The data presented is based on the best response achieved following a single dose of KALBITOR (Dose A) for the first HAE treatment episode. Responses of “a lot better or resolved” and “a little better” were combined to form a category of “Better.” Similarly, “a little worse” and “a lot worse” were combined to form a category of “Worse.” Patients treated in a clinic (study site) could have been discharged after an hour and hence may have only had 2 post-treatment evaluations (30 and 60 minutes); response assessments may not have been consistently provided when patients were treated at an alternate site outside of the study site.|within 4 hours post dose|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR. Analysis only includes episodes of patients who were treated at the study site.|||participants|||Number
1424678|NCT01059526|Primary|Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR|Events of ecchymosis, hemorrhage, petechiae, spontaneous hemorrhage, hematoma, gastrointestinal bleeding, hemorrhagic stroke and any other term indicative of a bleeding event or increased tendency for bleeding were reviewed to determine the occurrence of hypocoagulability. Events of clotting, thrombosis, pulmonary embolism, vaso-occlusive stroke, myocardial infarction, and any other term indicative of a clotting event or increased risk of clotting were reviewed to determine the occurrence of hypercoagulability.|12 months after first treatment||||participants||95% Confidence Interval|Number
1424679|NCT01059526|Primary|Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.|"Seroconversion is the development of detectable specific antibodies in the blood serum. Serum was tested for development of antibodies (irrespective of immunoglobulin class) against ecallantide at screening and at all safety evaluations. Positive results were to undergo a confirmatory test. Confirmed positive samples were further titered. Patients who developed an antibody response were evaluated for the development of neutralizing antibodies.~Patients also had their serum analyzed for IgE-specific antibodies to ecallantide at screening and during safety evaluations. Positive results underwent a confirmatory test. Confirmed positive samples were further titered."|12 months after first treatment|Based on total number of patients who were not positive for the antibody class at study entry and had at least one post-baseline antibody evaluation. N=40 evaluable patients for all immunoglobulin antibody classes; N=41 evaluable patients for IgE to ecallantide antibodies; N=41 evaluable patients for neutralizing antibodies to ecallantide.|||participants||95% Confidence Interval|Number
1424680|NCT01059526|Primary|Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity|Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients with any of these TEAE referred terms were reviewed further to assess potential hypersensitivity reactions, considering factors such as timing of TEAEs in relationship to dose (ie, occurred within 24 hours after start of KALBITOR treatment), accompanying symptoms, Investigator causality assessment (ie, reported as possibly, probably, or definitely related to study drug), and any other available clinical information. Anaphylaxis subset determined based on criteria established by the NIAID.|12 months after first treatment|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR|||participants||95% Confidence Interval|Number
1424681|NCT01059344|Post-Hoc|To Achieve Clinical Remission in the Patient Population Confirmed by the Central Reader|Clinical Remission, defined as stool frequency score of 0, rectal bleeding score of 0 and absence of urgency in subjects with adequate disease extent at baseline confirmed by central reading.|6 weeks|modified ITT, eligibility confirmed by central reader|||Participants|||Count of Participants
1424682|NCT01059344|Secondary|Improvement|Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)|10 weeks|ITT|||Participants|||Count of Participants
1424683|NCT01059344|Secondary|Improvement|Improvement is defined as a reduction of at least 3 points from baseline in the modified UC-DAI score. (minumum 3, maximum 7, higher absolute UC-DAI scores indicate more severe disease)|6 weeks|ITT|||Participants|||Count of Participants
1424684|NCT01059344|Secondary|Endoscopic Remission|Endoscopic remission is defined as a sigmoidoscopy score of 1 or less|10 weeks|ITT|||Participants|||Count of Participants
1424685|NCT01059344|Secondary|Endoscopic Remission|Endoscopic remission is defined as a sigmoidoscopy score of 1 or less|6 weeks|ITT|||Participants|||Count of Participants
1424686|NCT01059344|Secondary|Clinical Remission|Clinical remission defined as a score of 0 for stool frequency, 0 for rectal bleeding and no urgency|10 weeks|ITT|||Participants|||Count of Participants
1424687|NCT01059344|Primary|To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).|Clinical remission defined as stool frequency score of 0, rectal bleeding score of 0, no urgency|6 weeks|ITT|||participants|||Number
1424688|NCT01059305|Primary|Overall Response|Response Evaluation Criteria In Solid Tumors (RECIST) criteria for CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = inevaluable. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum of diameters of target lesions, reference smallest sum on study (this includes baseline sum if is smallest on study). In addition to relative increase of 20%, sum must absolute increase at least 5 mm. (Note: appearance of 1/> new lesions also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study. Not evaluable (NE): Inevaluable when no imaging/measurement done|4 weeks||||Participants|||Count of Participants
1425292|NCT01052480|Secondary|Duration of Stay in ICU|Days that a participant spent in ICU. Multiple ICU admissions are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1424696|NCT01059175|Secondary|"Distribution of Improved, Unchanged and Worsened Patients as Defined Per M. Packer's Clinical Composite Score"|"Distribution of improved, unchanged and worsened patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved.~Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened.~Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.~Unchanged : if none of the previous definition applies."|24 months||||participants|||Number
1424697|NCT01059175|Primary|"Distribution of Improved, Unchanged and Worsened Patients as Defined Per M. Packer's Clinical Composite Score"|"M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved.~Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened.~Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved.~Unchanged : if none of the previous definition applies."|12 months||||participants|||Number
1424698|NCT01059071|Secondary|AUC of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID|||(mcg/ml) * hr||Standard Deviation|Mean
1424699|NCT01059071|Secondary|Cmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID|||mcg/ml||Standard Deviation|Mean
1424700|NCT01059071|Secondary|Tmax of DFMO in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 1 Day 8 at hour 0 (pre-dose), 30 minutes, 1 hour, 3 hours, and 6 hours|Cohort at max dose of 1500mg/m2 BID|||hours||Standard Deviation|Mean
1424701|NCT01059071|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.|||participants|||Number
1424702|NCT01059071|Secondary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years|18 subjects out of the 21 enrolled were evaluable. 3 subjects did not make it to an evaluable time point.|||Days||95% Confidence Interval|Median
1424703|NCT01059071|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of DFMO as a single agent and in combination with etoposide in pediatric and young adult patients with refractory or recurrent neuroblastoma|length of study plus 30 days|Received at least one dose of DFMO|||participants|||Number
1424704|NCT01058993|Primary|Blood Neutrophil Counts.|Effectiveness of drug based on increases of blood neutrophil counts to greater than 2.0 x 10^9 per liter|up to 14 days, depending on when subject reached peak response, i.e., the highest count after the stimulus (plerixafor)|The number of participants (6) was determined by the fact that we were studying a rare form of neutropenia, WHIMS syndrome, and we therefore recruited subjects who have WHIMS who live on the West coast. Analysis was per protocol.|||10^9 per Liter||Standard Deviation|Mean
1424705|NCT01058941|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 18 Months|The ADAS-cog assesses general cognitive function over multiple domains and evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates greater impairment on a range of scores from 0 to 70. A total score of 70 indicates maximum severity.|Baseline and 18 months|Twenty participants discontinued from the study prior to completing all study visits. One placebo and one treatment participant did not complete the final ADAS-cog assessment.|||units on a scale||Standard Deviation|Mean
1424706|NCT01058941|Primary|Change From Baseline in Activities of Daily Living (ADL) at 18 Months|The Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale (ADCS-ADL) is used to assess activities of daily living in people with AD using a structured interview to ask the AD participant’s caregiver/study partner to assess functional ability over a wide range of performance measures. A higher ADL score indicates greater impairment in functional ability; scores range from 0 to 27.|Baseline and 18 months|Twenty participants discontinued from the study prior to completing all study visits. One treatment participant did not complete the final ADL assessment.|||units on a scale||Standard Deviation|Mean
1424707|NCT01058863|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Day 37|Safety population of all randomized participants who received at least one dose of randomized study medication.|||participants|||Number
1424730|NCT01058304|Secondary|Short Performance Physical Battery (SPPB)|"This battery of objective physical function tests examines participants’ balance (3 tests), gait speed (8-foot walk), and time to rise from a chair and return to the seated position five times. For each test, the possible range if scores is 0-4, for a total range of 0-20 for all five tests, with higher scores indicating better function.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12 weeks|All enrolled, randomized participants|||units on a scale||95% Confidence Interval|Mean
1424708|NCT01058863|Secondary|Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)|"Percent-predicted FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. Percent-predicted FEV1 is the expected FEV1 taking into account age, height, gender and race, as per the National Health and Nutrition Examination Survey III (NHANES III) reference values.~The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment|||% predicted * hour||Standard Error|Mean
1424709|NCT01058863|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~The first baseline spirometry was obtained between 6-11 AM. The highest FEV1 value from two acceptable values was captured for calculation of the efficacy endpoints. Assessments were obtained at approximately 0.5 hours and immediately before dosing, and 5 minutes, 0.25, 0.50, 0.75, 1, 2, 3, 4, 5 and 6 hours after completion of dosing."|Day 1 up to Day 30|Intent to treat population: randomized participants who received at least 1 dose of randomized study medication and had at least 1 post-baseline assessment|||L*hour||Standard Error|Mean
1424710|NCT01058668|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator’s assessment of overall severity of the participant’s illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
1424711|NCT01058668|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant’s perception of his or her condition over the previous 48 hours, as well as the physician’s clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
1424712|NCT01058655|Secondary|Overall Survival (OS) [Phase II]|OS based on the Kaplan-Meier method is defined as the time from study entry to death or date last known alive.|Long-term follow-up for survival was not specified per protocol. Participants were followed for up to 20 months on this study.|The analysis dataset is comprised of all evaluable phase II patients.|||months||95% Confidence Interval|Median
1424713|NCT01058655|Secondary|Disease Control Rate (DCR) [Phase II]|Disease Control Rate is defined as the percentage of patients who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was assessed every 2 cycles on treatment. Median treatment duration on this study cohort was 2 months (range 1-16).|The analysis dataset is comprised of all evaluable phase II patients.|||percentage of participants||95% Confidence Interval|Number
1424714|NCT01058655|Primary|Progression-Free Survival (PFS) [Phase II]|PFS based on the Kaplan-Meier method is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the earliest date of last disease assessment. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was assessed radiographically to document clinical progression every 2 cycles on treatment. Participants were followed for up to 16 months since study entry.|The analysis dataset is comprised of all evaluable phase II patients.|||months||95% Confidence Interval|Median
1424731|NCT01058304|Primary|Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)|"WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). All items are rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0-96, with higher scores indicating worse symptoms.~Note that the baseline mean is a common baseline mean generated from the mixed model used for the primary study analysis. The raw mean for this outcome, overall and by study group, is presented in the table of baseline participant characteristics."|12-weeks, 24-weeks|All enrolled, randomized participants|||units on a scale||95% Confidence Interval|Mean
1425051|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator|Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.|||participants|||Number
1424715|NCT01058655|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as a treatment-related (attribution possible, probable, definite) adverse event that meets any of the following criteria: Grade 3 (G3) or higher non-hematologic toxicity (excluding, nausea, vomiting, diarrhea, alopecia, hypertension, hypercholesterolemia, or hypertriglyceridemia); G3 diarrhea, nausea or vomiting lasting > 48 hours or leading to hospitalization, despite aggressive anti-diarrheal or anti-emetic medications; G4 diarrhea, despite aggressive anti-diarrheal medications; G4 vomiting, despite aggressive anti-emetic medications; G3 hypertension, for which blood pressure cannot be reduced to <150/100 with anti-hypertensive therapies; G4 hypertension or severe hypertension, as defined by systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg; G4 hypercholesterolemia or hypertriglyceridemia lasting > 7 days, despite appropriate use of anti-hyperlipidemic medications; G4 hematologic toxicity lasting for >5 days, including leukopenia, neutropen|Patients were assessed continuously for toxicity while on study. The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for DLT. The 2 DLTs experienced by participants in dose level cohort 3 were grade 3 fatigue and dehydration.|||Participants with DLT|||Number
1424716|NCT01058655|Primary|Tivozanib Maximum Tolerated Dose (MTD) [Phase I]|The tivozanib MTD in combination with everolimus is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.|||mg daily for 3 weeks of a 4 week cycle|||Number
1424717|NCT01058655|Primary|Everolimus Maximum Tolerated Dose (MTD) [Phase I]|The everolimus MTD in combination with tivozanib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|Patients were assessed continuously for toxicity while on study. The observation period for MTD evaluation was the first 28 days (cycle 1) of treatment.|All PI patients who received at least one dose of the study drug were evaluable for MTD unless patient withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity.|||mg daily for 4 weeks of a 4 week cycle|||Number
1424718|NCT01058642|Primary|Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period)|The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period.|Baseline, Week 2 of Treatment Period 1 or 2|Zero participants were analyzed, and no data was collected for this measure. Due to lack of efficacy of ADL5747, the study was terminated early.||||||
1424719|NCT01058421|Secondary|Institution Free Days|Median number of days subjects were alive and free of hospitalization or living in a long-term care, rehabilitation, or skilled nursing facility.|Day 180|"Deceased subjects were not included in subsequent Period beginning subject started totals.~55 (subjects started Period 1) minus 13 (deceased subjects in Periods 1 & 2) = 46 started Period 3.~61 (subjects started Period 1) minus 11 (deceased subjects in Periods 1 & 2) = 50 started Period 3."|||Days||Inter-Quartile Range|Median
1424720|NCT01058421|Secondary|Institution Free Days|Median number of days subjects were alive and free of hospitalization or living in a longer-term care, rehabilitation, or skilled nursing facility.|At Day 90|"Deceased subjects were not included in subsequent Period beginning subject started totals.~59 (Subjects started Period 1) minus 10 (deceased subjects during Period 1) = 49 started Period 2.~61 (Subjects started Period 1) minus 6 (deceased subjects during Period 1) = 55 started Period 2."|||Days||Inter-Quartile Range|Median
1424721|NCT01058421|Secondary|Discharged to Home|Percentage of subjects discharged to home from study hospital|Through Day 28||||percentage of participants|||Number
1424722|NCT01058421|Secondary|Hospital Length of Stay|The total number of hospital days during study participation, up to 180 days.|up to 180 days||||Days||Inter-Quartile Range|Median
1424723|NCT01058421|Secondary|Hospital Free Days||Through Day 28||||Days||Inter-Quartile Range|Median
1424724|NCT01058421|Secondary|Mechanical Ventilation Duration|The total number of ventilated days from hospital admission to extubation, death or discharge over the complete duration of study participation, up to 180 days.|up to 180 days||||Days||Inter-Quartile Range|Median
1424725|NCT01058421|Secondary|ICU Length of Stay|Median ICU length of stay through Day 28|Total Days through Day 28||||Days||Inter-Quartile Range|Median
1424726|NCT01058421|Secondary|ICU-free Days|Number of ICU-free days at Day 28.|Day 28||||Days||Inter-Quartile Range|Median
1424727|NCT01058421|Primary|The Primary Outcome Variable for This Study Will be the Short Form of the Continuous Scale Physical Functional Performance Test (CS-PFP) Called the PFP-10|The CS-PFP-10 provides an overall score and scores for upper body strength, upper body flexibility, lower body strength, balance and coordination, and endurance. The test is used to assess an individual's overall capacity to carry out activities of daily living by measuring and quantifying 10 typical activities including sweeping a floor, transferring clothes from a washer to a dryer, and carrying groceries. Tasks are quantified using time alone, time and weight, and distance. This test provides a realistic and practical measure of movement capacity and ability to accomplish sustained activity. CS-PFP-10 scores are scored from 0 to 100, with higher scores indicating better function. If patients remained in the hospital or in a long-term care facility a the time of assessment, then received a score of 0. All tests were conducted in a standardized physical therapy laboratory by a physical therapist formally trained in conducting the CS-PFP-10 and blinded to group/arm assignment.|1 month|41 of 59 subjects were analyzed in the Intensive Treatment Group (20 completed outcomes testing + 5 remained in hospital + 16 remained in another facility = 41 subjects). 48 of 61 Standard of Care Group subjects were analyzed (19 completed outcomes testing + 12 remained in hospital + 17 remained in another facility = 48).|||score||Standard Error|Mean
1424728|NCT01058356|Secondary|Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)||Up to14 days||||participants|||Number
1424732|NCT01058265|Primary|Short Form 36 (SF-36) Mental Component Summary (MCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Mental Component Summary ranges from 0 to 100, and higher score indicates better mental health status. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months||||Scores on a scale||Inter-Quartile Range|Median
1424733|NCT01058265|Primary|Short Form 36 (SF-36) Physical Component Summary (PCS)|It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Physical Component Summary ranges from 0 to 100, and higher score indicates better physical condition. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.|3 months||||Scores on a scale||Inter-Quartile Range|Median
1424734|NCT01058239|Secondary|Treatment Related Toxicities|The toxicities experienced by participants that were deemed to be related to the study treatment. Data is shown as the number of participants that experienced any grade toxicity that was deemed to be related to treatment. Toxicities were assessed with the use of Common Toxicology Criteria for Adverse Events (CTCAE).|2 years||||participants|||Number
1424735|NCT01058239|Secondary|Effects of Bortezomib/Rituximab on EBV Quantitative Viral Load|The Mean epstein barr virus (EBV) viral load at the given time points.|baseline, 21, 42, 63, 84 days (end of cycles 1, 2, 3, 4)|Not all participants completed four cycles of treatment. The number of participants analyzed in each row differs according to the number of participants available for analysis at each time point.|||Log2[(viral copies/ milliliter blood)+1]||Standard Deviation|Mean
1424736|NCT01058239|Secondary|Overall Survival|The percent of participants surviving at 6 months and 1 year.|6 months, 1 year||||percentage of participants||90% Confidence Interval|Number
1424737|NCT01058239|Secondary|Six-Month Progression Free Survival|"Percent of participants with progression free survival (alive without disease progression) six months after registration. Progression was evaluated using the International Working Group criteria for lymphoma response.~> Progressive Disease (PD) or Relapsed Disease (RD):~Appearance of any new lesion > 1.5 cm in any axis during or at end of therapy. Increased Radiolabeled[18F]-2-fluoro-2-deoxy-D-glucose (FDG) uptake in a previously unaffected site will be considered PD/RD only after confirmation by other modalities.~≥ 50% increase from nadir in the sum of the products of the largest diameters (SPD) of any previously involved node, or in a single involved node, or in the sizes of other lesions.~≥ 50% increase in the longest diameter of any single previously identified node > 1 cm in its short axis.~PET (positron emission tomography) positive prior to therapy: post-treatment PET should be positive unless lesion is too small to be detected with current PET sys"|six months||||percentage of participants||90% Confidence Interval|Number
1424738|NCT01058239|Secondary|Complete Response Rate|"The number of participants with complete responses as assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response.~Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy."|4 Months||||Participants|||Count of Participants
1424739|NCT01058239|Primary|Overall Response Rate|"Overall response rate includes both complete and partial responses assessed by PET/CT following completion of therapy. Response was evaluated using the International Working Group criteria for lymphoma response. The complete list of criteria used to evaluate response is too long to be detailed in the allotted space here, but response is defined more generally as:~Complete Response (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~Partial Response (PR): ≥ 50% decrease in the sum of the products of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses."|4 months||||Participants|||Count of Participants
1424740|NCT01058096|Secondary|Change From Baseline in Clinical Global Impression–Severity (CGI-S) Total Score at Week 3|The CGI-S measures the investigator’s assessment of overall severity of the participant’s illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
1424741|NCT01058096|Primary|Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3|The YMRS is an 11-item scale that assesses manic symptoms based on the participant’s perception of his or her condition over the previous 48 hours, as well as the physician’s clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.|Baseline, Week 3|Intent-to-treat Population included all participants who received at least 1 dose of study drug and who had at least 1 post-baseline YMRS assessment.|||score on a scale||Standard Error|Least Squares Mean
1424742|NCT01058070|Primary|To Monitor the Improvement of GERD Symptoms.|Percentage of participants with a 50% or more reduction in total GERD-HRQL score is indicative of a substantial improvement in GERD symptoms|5 years||||percentage of participants|||Number
1424743|NCT01058070|Primary|To Evaluate the Incidence of All Adverse Events at Various Time Points.||5 years||||participants|||Number
1439467|NCT00939198|Primary|Size of Wheal Diameter at Site of Skin Test Application, Measured 15 Minutes After Injection||15 minutes after skin test application||||cm||Inter-Quartile Range|Median
1424744|NCT01058005|Primary|Incidence of Treatment-emergent Serious Adverse Events (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.|up to 108 Weeks|Participants who received at least 1 dose of study medication.|||participants|||Number
1424745|NCT01057901|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.|||units on a scale||Standard Error|Least Squares Mean
1424746|NCT01057901|Primary|Change From Baseline in the Number of Satisfying Sexual Events|"The change from baseline in the number of SSE’s as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).~Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question."|baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had usable data.|||SSEs/month||Standard Deviation|Mean
1424747|NCT01057888|Primary|Well Child Care Status|Received recommended well child care visit|12 months||||participants|||Number
1424748|NCT01057888|Primary|Fully Vaccinated (Tdap, Menactra and 3 Doses of HPV (if Female))||12 months|Individuals were randomized to one of 3 groups (letter reminders, telephone reminders or control). Individuals with a wrong/missing telephone number or a wrong address were excluded from the analyses. This left 1,396 in the letter reminder group, 1,423 in the telephone reminder group and 1,296 in the control group.|||participants|||Number
1424749|NCT01057862|Secondary|Gambling Symptom Assessment Scale (G-SAS)|The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. Each item on the 12-item scale has a score ranging from 0 – 4. All items ask for an average symptom based on the past 7 days. Total score ranges from 0 – 48: extreme = 41 – 48, severe = 31 – 40, moderate = 21 – 30, mild = 8 – 20.|Weekly/bi-weekly visits|Enrollment was lower than expected and due to the low numbers of subjects completing the study (8 subjects completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.|||units on a scale||Standard Deviation|Mean
1424750|NCT01057862|Primary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (YBOCS-PG)|The Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) was developed to measure the severity and change in severity of pathological gambling symptoms.The PG-YBOCS is a 10-item clinician-administered questionnaire that measures the severity of PG over a specified time interval. Scores of 0 through 4 are assigned to each question according to the severity of the response (0 = least severe response, 4 = most severe response). The first five questions assess urges and thoughts associated with pathological gambling, whereas the last five questions assess the behavioral component of the disorder. Each set of questions is totaled separately as well as together for a total score. The total score can range from 0 (low) to 40 (most severe) with higher numbers representing a more severe form of pathological gambling.|Weekly/bi-weekly visits|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects completed all interventions - 5 naltrexone and 2 placebo) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses.|||units on a scale||Standard Deviation|Mean
1424751|NCT01057810|Secondary|Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities|"NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria:~White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L.~Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L.~Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN."|Randomization up to April 2015, approximately 57 months|All treated participants with on-study laboratory results|||participants|||Number
1424803|NCT01057225|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier|From baseline to end of active treatment|All enrolled patients who began treatment were evaluated for safety and response.|||months||95% Confidence Interval|Number
1440908|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at Month 3|Month 3|Full Analysis Set - Participants with Observed Data|||mg/day||95% Confidence Interval|Mean
1424752|NCT01057810|Secondary|Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 1 of study therapy to last dose plus 70 days|All treated participants|||participants|||Number
1424753|NCT01057810|Secondary|Time to Pain Progression|"Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10).~Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism."|Randomization until pain progression, up to April 2015, approximately 57 months|All randomized participants|||months||95% Confidence Interval|Median
1424754|NCT01057810|Secondary|Time to Subsequent Non-hormonal Cytotoxic Therapy|For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).|Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months|All randomized participants who received subsequent non-hormonal cytotoxic therapy|||months||95% Confidence Interval|Median
1424755|NCT01057810|Secondary|Progression-Free Survival (PFS) Time|Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.|Randomization until disease progression, up to April 2015, approximately 57 months|All randomized participants|||months||95% Confidence Interval|Median
1424756|NCT01057810|Primary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.|Randomization until death from any cause, up to April 2015, approximately 57 months|All randomized participants|||months||95% Confidence Interval|Median
1424757|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)|GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.|Week 19|"FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||participants|||Number
1424758|NCT01057693|Secondary|Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)|GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered “how would you rate the study medication you received for pain?” on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.|Week 6|"SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||participants|||Number
1424759|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1424760|NCT01057693|Secondary|Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)|HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.|||units on a scale||Standard Deviation|Mean
1424817|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Sodium (MPS)|Safety population per visit and per treatment group|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.|||mg|Participants|Standard Deviation|Mean
1440909|NCT00928408|Primary|Cinacalcet Dose|Cinacalcet dose at initiation of treatment|Initiation of treatment|Full Analysis Set|||mg/day||95% Confidence Interval|Mean
1424761|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1424762|NCT01057693|Secondary|Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)|BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.|||units on a scale||Standard Deviation|Mean
1424763|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Double-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
1424764|NCT01057693|Secondary|Pain Visual Analog Scale (VAS) (Single-Blind Phase)|Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time-point.|||mm||Standard Deviation|Mean
1424765|NCT01057693|Secondary|Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1424766|NCT01057693|Secondary|Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)|QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “n” signifies participants who were evaluable for specified time point.|||units on a scale||Standard Deviation|Mean
1424767|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Double-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1424768|NCT01057693|Secondary|Endpoint Mean Sleep Interference Score (Single-Blind Phase)|Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1424769|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Double-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1424818|NCT01056822|Secondary|Duration of Exposure to the Study Medicinal Product, Mycophenolate Sodium Descriptive Statistics. Safety Population Per Treatment Group|Exposure to study drug (MPS). Data presented only for safety population on the study treatment arm (not applicable for MMF arm)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.|||days|Participants|Standard Deviation|Mean
1424770|NCT01057693|Secondary|Weekly Mean Sleep Interference Score (Single-Blind Phase)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time point.|||units on a scale||Standard Deviation|Mean
1424771|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.|||participants|||Number
1424772|NCT01057693|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.|||participants|||Number
1424773|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1424774|NCT01057693|Secondary|Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.|SB Baseline, Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here “n” signifies participants who were evaluable for specified time-point.|||units on a scale||Standard Deviation|Mean
1424775|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Double-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1424776|NCT01057693|Secondary|Patient Global Impression of Change (PGIC) (Single-Blind Phase)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1424777|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.|Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.|||percentage of participants|||Number
1424778|NCT01057693|Secondary|Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|Week 6|SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.|||percentage of participants|||Number
1424861|NCT01056718|Secondary|Peak Stress Diastolic BP||10 Week||||mm Hg||Standard Deviation|Mean
1424862|NCT01056718|Secondary|Peak Stress Systolic BP||10 Week||||mm Hg||Standard Deviation|Mean
1424863|NCT01056718|Secondary|Diastolic BP||10 Week||||mm Hg||Standard Deviation|Mean
1428836|NCT01018511|Secondary|Maximum Concentration at Steady State (Cmaxss) of Tamsulosin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1424779|NCT01057693|Secondary|Weekly Mean Pain Scores (Double-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.|DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here “n” signifies participants who were evaluable for specified time-point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1424780|NCT01057693|Secondary|Weekly Mean Pain Scores (Single-Blind Phase)|Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.|Week 1, 2, 3, 4, 5, 6|SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time-point.|||units on a scale||Standard Deviation|Mean
1424781|NCT01057693|Secondary|Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 6 (SB Phase)|Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. “N” (number of participants analyzed): participants who were evaluable for this measure and “n”: participants who were evaluable for specified time-point. Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1424782|NCT01057693|Secondary|Time to Loss of Pain Response (Double-Blind Phase)|Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline up to Week 19|FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.|||days||95% Confidence Interval|Median
1424783|NCT01057693|Primary|Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.|SB Baseline, Week 19 (DB Phase)|Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1424784|NCT01057589|Secondary|Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)|PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant’s speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.|Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)|PQ Population: all randomized and treated participants with evaluable data at respective timepoint.|||units on a scale||Standard Deviation|Mean
1424785|NCT01057589|Secondary|Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy|EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 [no limitation], 2 [some limitation] or 3 [severe or complete limitation] in 5 dimensions [mobility, self-care, usual activities, pain/comfort and anxiety/depression]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).|Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.|||units on a scale||Standard Deviation|Mean
1424786|NCT01057589|Secondary|Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy|Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit).|Baseline, End of Triplet Combination Therapy (up to Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data for each category|||units on a scale||Standard Deviation|Mean
1424787|NCT01057589|Secondary|Percent of Participants With a Partial Response (PR) or a Complete Response (CR)|CR and PR based on RECIST Guidelines: CR is defined as the disappearance of all tumor lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or the complete disappearance of target lesions, with persistence (but not worsening) of one or more nontarget lesions and the appearance of no new lesions. PD is defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of first response to PD (up to 18.7 months)|PQ Population: all randomized and treated participants with evaluable data; 6 participant's results were unknown.|||percentage of participants||95% Confidence Interval|Number
1424788|NCT01057589|Secondary|Overall Survival (OS)|OS defined as the time from the date of first dose of study drug to the date to death from any cause.|Baseline to date of death up to 18.7 months|PQ Population: all randomized and treated participants|||months||95% Confidence Interval|Median
1424789|NCT01057589|Primary|Progression Free Survival (PFS)|PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Baseline to date of PD or death up to 18.7 months|Protocol Qualified (PQ) Population: all randomized and treated participants|||months||95% Confidence Interval|Median
1424790|NCT01057433|Secondary|Adverse Events||24 Days|||||||
1424791|NCT01057433|Primary|Area Under the Curve From Time 0 to Tau (AUC 0-τ)|Area under the curve from start to elimination.|12 hours||||ng•h/mL||Standard Deviation|Mean
1424792|NCT01057394|Primary|Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation|Number of initially isolated pulmonary veins that remain isolated at a 3 month remapping. The unit of measure is treated pulmonary veins (PVs).|3 Months|Of the 21 enrolled participants, 19 were treated participants and 17 of the 19 came back for the 3 month PV remapping and were thus evaluable for effectiveness. This resulted in 46/59 (78%) pulmonary veins being assessed for chronic isolation.|||isolated pulmonary veins|||Number
1424793|NCT01057277|Primary|Response||1 year||||participants|||Number
1424794|NCT01057251|Primary|Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline (Week 0) to Visit 4 (Week 6)||||mm Hg||Standard Deviation|Mean
1424795|NCT01057251|Primary|Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy|Office blood pressure measured at trough by automatic oscillometric device.|Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)||||mm Hg||Standard Deviation|Mean
1424796|NCT01057225|Secondary|Overall Survival (24 Month)|24 Month Overall survival is defined as the proportion of patients to still be alive after 24 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of patients||95% Confidence Interval|Number
1424797|NCT01057225|Secondary|Overall Survival (12 Month)|12 Month Overall survival is defined as the proportion of patients to still be alive after 12 months.|From baseline to death|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of patients||95% Confidence Interval|Number
1424798|NCT01057225|Secondary|Progession Free Survival (24 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 24 month mark.|24 months|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of participants at 24 months||95% Confidence Interval|Number
1424799|NCT01057225|Secondary|Progression Free Survival (12 Month)|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression 1 day post-registration. This is reported as the percentage of patients alive and progression free at the 12 month mark.|12 months|All of the 64 participants that were eligible and began treatment were evaluated.|||percentage of participants at 12 months||95% Confidence Interval|Number
1424800|NCT01057225|Secondary|Survival Time (Phase II)|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|From baseline to death||||months||95% Confidence Interval|Median
1424801|NCT01057225|Secondary|Complete Response (Phase II)|In patients continuing beyond 4 cycles the ability to induce complete response will be evaluated at completion of planned therapy.|Following the first 4 courses of treatment||||participants|||Number
1424802|NCT01057225|Secondary|Stem Cell Collection and Engraftment (Phase II)|For patients going on to stem cell collection, the total number of CD34 positive cells collected per collection, days to platelets over 20,000 without transfusion and ANC over 1000 will be recorded. If a patient fails to collect adequate stem cells for transplant, this will be recorded as such. The number of patients with successful stem cell mobilization are reported.|Following the first 4 courses of treatment|Of the 64 patients that began protocol treatment, stem cell harvesting was attempted on 42 patients.|||participants|||Number
1425052|NCT01054820|Secondary|Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant|Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.|End of Treatment (last visit up to Day 15)|ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.|||participants|||Number
1424804|NCT01057225|Secondary|Progression-free Survival (Phase II)|"PFS was defined as the time from registration to progression or death due to any cause. Progression was defined as any one or more of the following:~• Increase of 25% from lowest confirmed response in: Serum M-component (absolute increase must be ≥ 0.5 g/dl)c Urine M-component (absolute increase must be ≥ 200 mg/24 hour) If at on study, only the measurable non-bone marrow parameter was FLC, the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl) Bone marrow plasma cell percentage (absolute % must be 10%)d Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~• Development of hypercalcemia (corrected serum calcium >11.5 mg/dl) that can be attributed solely to the plasma cell proliferative disorder"|From baseline to progression or death up to 3 years|All of the 64 participants that were eligible and began treatment were evaluated.|||months||95% Confidence Interval|Number
1424805|NCT01057225|Primary|Percentage of Patients Who Have at Least a Confirmed Very Good Partial Response (Phase II)|"The proportion of patients who have at least a confirmed very good partial response will be calculated by taking the number of patients with a very good partial response or a complete response divided by the total number of patients.~A complete response is defined as:~Negative immunofixation of the serum and urine~If at on study, only the measurable non-bone marrow parameter was FLC, normalization of FLC ratio~< 5% plasma cells in bone marrow~Disappearance of any soft tissue plasmacytomas~A very good partial response is defined as:~Serum and urine M-component detectable by immunofixation but not on electrophoresis or~If at on study, serum measurable, ≥ 90% or greater reduction in serum Mcomponent~Urine M-component <100 mg per 24 hour"|Following the first 4 cycles of treatment (28 day cycles)|All enrolled patients who began treatment were evaluated for safety and response.|||percentage of participants|||Number
1424806|NCT01057225|Primary|Maximum Tolerated Dose (Phase I)|"To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone.~For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, possibly) in the first or second cycle for patients enrolled to Dose Levels -1 and 0 and in the first cycle only for patients enrolled to Dose Levels 1 and 2.~We are reporting the number of DLTs"|From baseline to end of active treatment, up to 12 28-day cycles.|All patients registered to a dose escalation Phase I group were analyzed for this endpoint.|||participants|||Number
1424807|NCT01057121|Other Pre-specified|Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load|Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration.|Up to 30 days after completion of study treatment|The KSHV (HHV-8) assays were run, but the results were unreliable.||||||
1424808|NCT01057121|Secondary|Time to Response|"time from enrollment to first response (complete or partial) as defined below: Complete response is defined as the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks.~Partial response is defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions lasting for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Participants who had a complete or partial responses|||weeks||Full Range|Median
1424809|NCT01057121|Secondary|Time to Relapse|Percentage of participants who relapsed|Up to 30 days after completion of study treatment|Patients who relapsed||||||
1424810|NCT01057121|Secondary|Time to Death|Percentage of patients who died|Up to 30 days after completion of study treatment|Study participants who died on study.|||percentage of participants who died|||Number
1424811|NCT01057121|Primary|Tumor Response Rate|"Percentage of patients who achieve a partial or complete response Complete response was defined as the absence of any detectable residual disease, including tumor-associated edema, that persisted for at least 4 weeks.~Partial response was defined as no new lesions (skin or oral), or new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions), and a 50% or greater decrease in the number of all previously existing lesions that lasted for at least 4 weeks, or complete flattening of at least 50% of all previously raised lesions, or a 50% or greater decrease in the sum of the products of the largest perpendicular diameters of the marker lesions."|Up to 30 days after completion of study treatment|Patients who were evaluable for response. To be evaluable for response, the patient had to complete at least one cycle of treatment.|||percent of participants who responded||95% Confidence Interval|Number
1424812|NCT01057121|Primary|Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)|Maximum tolerated dose (MTD) of lenalidomide defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the MTD is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle.|28 days|Only patients in the phase I portion of the study were evaluated for this outcome measure.|||mg per day of lenalidomide|||Number
1424813|NCT01057017|Primary|Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab|To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3|every 3 weeks until patient comes off study (progressive disease), for up to 2 years||||participants|||Number
1424814|NCT01056913|Secondary|Clinical Relevant Stenosis||six months|||||||
1424815|NCT01056913|Primary|Anastomotic Leakage||4-8 weeks||||participants|||Number
1424816|NCT01056822|Secondary|Dose of the Study Medicinal Product Mycophenolate Mofetil (MMF)|Safety population per visit and per treatment group (missings not included)|at 12 months from baseline|The safety population included all randomised patients who gave signed informed consent and received at least one dose of the study medicinal product.|||mg|Participants|Standard Deviation|Mean
1440910|NCT00928395|Secondary|Change in Voiding Diary Parameters.||every three months for 36 months|||||||
1424819|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included|||scores on a scale|Participants|Standard Deviation|Mean
1424820|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
1424821|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424822|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424823|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424824|NCT01056822|Secondary|Change in SIGIT-QoL Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of SNP in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424825|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424864|NCT01056718|Primary|Metabolic Equivalent (METS) Level|METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.|10 Weeks||||METS||Standard Deviation|Mean
1424826|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424827|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the MRP2 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424828|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 5 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missing not included|||scores on a scale|Participants|Standard Deviation|Mean
1424829|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 4 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424830|NCT01056822|Secondary|Change in Gastrointestinal Symptom Rating Scale (GSRS) Score From Baseline to Visit 2 Stratified on the Basis of the Presence or Absence of Single-nucleotide Polymorphisms (SNPs) in the UGT1A9 Gene for the ITT Population|Sub-study primary endpoint. The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus)|||scores on a scale|Participants|Standard Deviation|Mean
1424831|NCT01056822|Secondary|Health-related Quality of Life (HRQoL): Impact of Gastrointestinal Symptoms on Quality Of Life (SIGIT)-QoL Questionnaire. Total Score.|The SIGIT-QoL scale is a 17 items instrument, the score of each item ranges from 0 (always) to 4 (never). The scale score is obtained by adding the scores of the 17 items. Therefore, the total score ranges from 0 to 68 points. Higher score means, less impairment of Health Related QoL of the patient and vice versa, the lower the score, the greater severity of symptoms and worse perceived by the patient|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
1424832|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Subscale Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
1424865|NCT01056718|Primary|Exercise Duration||10 Weeks||||Seconds||Standard Deviation|Mean
1424866|NCT01056718|Primary|Resting Systolic BP||10 Weeks||||mm Hg||Standard Deviation|Mean
1424867|NCT01056653|Secondary|Perceptions of Parenting an Infant - What Being the Parent of a Baby Is Like (WPL-R) Scale|25-item self-report measure composed of 3 subscales: Evaluation (11 items), Centrality (8 items), and Life Change (6 items). Each item is rated on a 9-point scale and subscale scores are obtained by averaging the scores of all items on a subscale; the range for all subscales is therefore 1 - 9. Higher scores reflect having more of the attribute being measured.|When the infant was 8 months old, adjusting for prematurity|Goup A Teal n = 45 due to missing data|||Scores on a scale||Standard Deviation|Mean
1424833|NCT01056822|Secondary|Gastrointestinal Symptom Rating Scale (GSRS) Item Score|The GSRS is a 15-item instrument design to assess the symptoms associated to gastrointestinal disorders. It has 5 subscales (reflux, diarrhoea, constipation, abdominal pain and indigestion) with scores rating from 1 to 7 (with a higher score representing more gastrointestinal symptoms)|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus). Missings not included|||scores on a scale|Participants|Standard Deviation|Mean
1424834|NCT01056822|Secondary|Glomerular Filtration Rate (GFR) Using Abbreviated MDRD|Calculated GFR (MDRD formula): GFR [mL/min/1.73m2] = 186.3*(C-1.154)*(A-0.203)*G*R where C is the serum concentration of creatinine [mg/dL], A is age [years], G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1|Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||mL/min/1.73m^2||Standard Deviation|Mean
1424835|NCT01056822|Secondary|Change in Renal Function Measured Using Cockcroft-Gault Creatinine Clearance (CrCl)||Visit 1 (30 days +/-4), visit 2 (90 days +/- 15), visit 3 (150 days +/- 15), visit 4 (210 days +/- 15), visit 5 (365 days +/- 15)|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||ml/min|Participants|Standard Deviation|Mean
1424836|NCT01056822|Primary|Mean Mycophenolic Acid (MPA) Doses at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Per protocol (PP) population included all subjects from the ITT population who received medication throughout the study and did not have major protocol deviations and who participated in the study for a minimum of 210 days +/- 15 days|||mg/day||Standard Deviation|Mean
1424837|NCT01056822|Primary|Participants With Reduction in Tacrolimus or Tacrolimus Extended Release Levels at the End of the Study (Final Visit) Compared to Baseline Dose.||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||Participants|||Number
1424838|NCT01056822|Primary|Number of Participants That Achieved One Dose Step Higher With Mycophenolic Acid (MPA) or Mycophenolate Mofetil (MMF), According to the Treatment Group Assigned at the End of the Study (Final Visit) Compared to Baseline Dose||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||study participants|||Number
1424839|NCT01056822|Primary|Number of Participants Achieving at Least Two Mycophenolic Acid (MPA) Dose Steps Higher and Reducing Tacrolimus Dose at the End of the Study||at 12 months from baseline|Intention-to-treat (ITT) population included all randomised patients who gave signed informed consent and received at least one dose of study medicinal product and had at least one baseline visit and one post-baseline visit (containing data to allow primary endpoint to be calculated, i.e. dose of MPA or MMF and Tacrolimus).|||number of participants|||Number
1424840|NCT01056718|Secondary|Quality of Life|"Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the best imaginable health state and 0 is the worst imaginable health state."|10 Weeks||||units on a scale||Standard Deviation|Mean
1424841|NCT01056718|Secondary|Pulmonary Vein Peak Diastolic Velocity||10 Week||||cm/s||Standard Deviation|Mean
1424842|NCT01056718|Secondary|Pulmonary Vein Peak Systolic Velocity||10 Week||||cm/s||Standard Deviation|Mean
1424843|NCT01056718|Secondary|E/e' Ratio||10 Week||||Ratio||Standard Deviation|Mean
1424844|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (a')||10 Week||||cm/s||Standard Deviation|Mean
1424845|NCT01056718|Secondary|Mitral Valve Tissue Doppler Velocity (e')||10 Week||||cm/s||Standard Deviation|Mean
1424846|NCT01056718|Secondary|Mitral Valve Deceleration Time||10 Week||||ms||Standard Deviation|Mean
1424847|NCT01056718|Secondary|Mitral Valve E/A Ratio|mitral valve doppler E velocity to A velocity|10 Week||||Ratio||Standard Deviation|Mean
1424848|NCT01056718|Secondary|Mitral Valve Inflow (A) Velocity||10 Week||||cm/s||Standard Deviation|Mean
1424849|NCT01056718|Secondary|Mitral Valve Inflow (E) Velocity||10 Week||||cm/s||Standard Deviation|Mean
1424850|NCT01056718|Secondary|LV Mass||10 week||||grams||Standard Deviation|Mean
1424851|NCT01056718|Secondary|LV End Systolic Diameter||10 week||||cm||Standard Deviation|Mean
1424852|NCT01056718|Secondary|LV End Diastolic Diameter||10 week||||cm||Standard Deviation|Mean
1424853|NCT01056718|Secondary|Stress Cardiac Output||10 week||||L per minute||Standard Deviation|Mean
1424854|NCT01056718|Secondary|Resting Cardiac Output||10 week||||L per minute||Standard Deviation|Mean
1424855|NCT01056718|Secondary|Stress Stroke Volume||10 week||||ml||Standard Deviation|Mean
1424856|NCT01056718|Secondary|Resting Stroke Volume||10 weeks||||ml||Standard Deviation|Mean
1424857|NCT01056718|Secondary|Stress EF||10 Week||||Percent of LV end diastolic volume||Standard Deviation|Mean
1424858|NCT01056718|Secondary|Resting EF||10 Weeks||||Percent of LV end diastolic volume||Standard Deviation|Mean
1424859|NCT01056718|Secondary|Stress Heart Rate||10 Week||||Beats per Minute||Standard Deviation|Mean
1424860|NCT01056718|Secondary|Resting Heart Rate||10 Week||||Beats per Minute||Standard Deviation|Mean
1424868|NCT01056653|Secondary|Parenting Stress - Parenting Stress Index - Third Edition (PSI-3)|"A 120-item self-report questionnaire of parenting stress with two domains. The Parent Domain (51 items) measures stress related to parental functioning, the Child Domain (50 items) measures child qualities and characteristics that contribute to stress in the parent-child system. The PSI-3 contains an additional Life Stress scale (19 items) which was not used in the study.~The range of possible scores in the Parent Domain is 50 - 250 and in the Child Domain is 51 - 255. In both domains, higher scores indicate more stress."|When the infant was 8 months old, adjusting for prematurity|Group A Teal n = 44 due to missing data|||Scores on a scale||Standard Deviation|Mean
1424869|NCT01056653|Primary|Parent Child Interaction Teaching Scale (PCITS)|"Assesses parent-infant interaction skills. Used for children from birth to 3 years of age. It is an observational measure of the presence of behaviours in parent-infant interactions.~The Parent Total (50 items) is the sum of 4 subscales: Sensitivity to Cues (11 items), Response to Distress (11 items), Social-Emotional Growth Fostering (11 items), and Cognitive Growth Fostering (17 items). Higher scores on all subscales and higher total scores reflect more optimal parent-infant interactions.~Possible ranges of scores are as follows: Parent Total (0 - 50), Sensitivity to Cues (0 - 11), Response to Distress (0 - 11), Social-Emotional Growth Fostering (0 - 11), and Cognitive Growth Fostering (0 - 17)"|When the infant was 8 months old, adjusting for prematurity||||Scores on a scale||Standard Deviation|Mean
1424870|NCT01056640|Primary|Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease.||12 months|This study utilized an intent-to-treat method. Everyone randomized to study was included in the analysis|||hospitalizations||Standard Deviation|Mean
1424871|NCT01056601|Secondary|Duration of Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).|Up to 1 Year||||Weeks|||Number
1424872|NCT01056601|Secondary|Number of Participants by Tumor Response|Number of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.|Up to 1 Year||||Participants|||Number
1424873|NCT01056601|Primary|Progression-Free Survival|Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.|Up to 1 Year||||Months||95% Confidence Interval|Median
1424874|NCT01056523|Secondary|Blast Response|Blast response was defined as a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days.|2-3 years|Only patients treated for 28 days or more were evaluable for response.|||Participants|||Count of Participants
1424875|NCT01056523|Secondary|Partial Response|Partial response was defined as 5 to 25% blasts in the bone marrow and Hgb >100g/L, platelets >100,000/ul and neutrophils >1000/ul.|2-3 years|Only patients treated for 28 days or more were assessed for response.|||Participants|||Count of Participants
1424876|NCT01056523|Secondary|Complete Response Rate|Defined as <5% blasts in the bone marrow and a hgb 100 g/L, platelets 100,000/uL, neutrophils 1000/uL.|2-3 years|Only patients treated for at least 28 days were evaluable for response.|||Participants|||Count of Participants
1424877|NCT01056523|Secondary|Overall Response Rate|Overall response rate comprises complete response (<5% blasts in the bone marrow, and in the peripheral blood Hgb more than or equal to 100 g/L, platelets more than or equal to 100x10-9/L, and neutrophils more than or equal to 1x10-9/L), partial response (5 to 25% blasts in the bone marrow and same peripheral blood parameters) and blast response (a greater than 50% decrease in bone marrow blast count and 2 log reduction in peripheral blood blast count, sustained for at least 28 days).|2-3 years|Only patients treated for 28 days or more were evaluable for response.|||Participants|||Count of Participants
1424878|NCT01056523|Primary|Recommended Phase II Dose (RP2D) of Ribavirin When Given in Combination With Low-dose Ara-C|This 3+3 designed aimed to determine recommended phase II dose (RP2D) based on pharmacokinetics (PK) and maximum tolerated dose (MTD). For the dose to be selected, a target steady state level of ribavirin 20 uM was needed for all patients and no more than 1 of 6 patients could have had dose limiting toxicity at that dose.|56 days||||mg|||Number
1424879|NCT01056510|Secondary|Proportion of Malignant B-cells in Normal B-cells Among Participants With a Positive Outcome for MRD in the First-Line Subpopulation|The proportion of malignant B-cells in normal B-cells was quantitatively determined, and was calculated as the number of malignant B-cells divided by the number of normal B-cells observed.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with a positive outcome for MRD were included in the analysis.|||proportion||Standard Deviation|Mean
1424880|NCT01056510|Secondary|Number of Participants With Positive and Negative Outcome for MRD in the First-Line Subpopulation|Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001, and positive MRD was defined as a proportion of malignant B-cells in normal B-cells >/= 0.0001.|After 6 treatment cycles (up to 24 weeks)|ITT Population (First-Line Subpopulation); only participants with available MRD data (MRD-evaluable participants) were included in the analysis.|||participants|||Number
1424881|NCT01056510|Secondary|Percentage of Participants Achieving Molecular Response in the First-Line Subpopulation|Molecular response was defined as negative minimal residual disease (MRD) during study treatment or within 4 months after the end of treatment. Negative MRD was defined as a proportion of malignant B-cells in normal B-cells < 0.0001. The percentage of participants achieving molecular response was calculated as the number of participants with negative MRD divided by the number of participants analyzed.|Up to 4 months after the last treatment cycle (up to 40 weeks)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR during study treatment or within 4 months after the end of treatment were considered in the analysis.|||percentage of participants|||Number
1440911|NCT00928395|Secondary|Change in OAB-q and SF-36 Questionnaires.||every three months for 36 months|||||||
1424882|NCT01056510|Secondary|Overall Survival (OS) in the First-Line Subpopulation|OS was defined as the time from recorded diagnosis to death from any cause. OS was calculated in months as [death date or last-known alive date minus diagnosis date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
1424883|NCT01056510|Secondary|Percentage of Participants Experiencing Death in the First-Line Subpopulation|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
1424884|NCT01056510|Secondary|Duration of Response in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nPR to the first documentation of PD or death, whichever occurred first. Duration of response was calculated in months as [first event date minus first assessment date of CR/CRi/PR/nPR plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.|||months||95% Confidence Interval|Median
1424885|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR, CRi, PR, or nPR Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, PR, nPR, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR, CRi, PR, or nPR were considered in the analysis.|||percentage of participants|||Number
1424886|NCT01056510|Secondary|Time to Next Leukemia Treatment (TNLT) in the First-Line Subpopulation|TNLT was defined as the time from the first dose of trial treatment to the first documentation of any new leukemia treatment. TNLT was calculated in months as [first new treatment date minus first dose date plus 1] divided by 30.44.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
1424887|NCT01056510|Secondary|Percentage of Participants With Documented Intake of New Leukemia Therapy in the First-Line Subpopulation|The percentage of participants with documented intake of new (post-trial) leukemia therapy was calculated as the number of participants with new therapy divided by the number of participants analyzed, multiplied by 100.|During Cycles 1 to 6 (both treatment arms), Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
1424888|NCT01056510|Secondary|Event-Free Survival (EFS) in the First-Line Subpopulation|The criteria for PD and SD are identified in previous outcome measure(s). EFS was defined as the time from the first dose of trial treatment to the first documentation of PD, the beginning of new treatment for any hematologic malignancy, or death from any cause. Those with SD were considered event-free. EFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
1424889|NCT01056510|Secondary|Percentage of Participants Experiencing PD, Documented Intake of New Leukemia Therapy, or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD, intake of new (post-trial) leukemia therapy, or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
1424890|NCT01056510|Secondary|Disease-Free Survival (DFS) in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). DFS was defined as the time from the first assessment of CR or CRi to the first documentation of PD or death, whichever occurred first. DFS was calculated in months as [first event date minus first assessment date of CR/CRi plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.|||months||95% Confidence Interval|Median
1424891|NCT01056510|Secondary|Percentage of Participants With Tumor Response of CR or CRi Experiencing PD or Death in the First-Line Subpopulation|The criteria for CR, CRi, and PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation); only participants with a tumor response of CR or CRi during study treatment or within 4 months after the end of treatment were considered in the analysis.|||percentage of participants|||Number
1424892|NCT01056510|Secondary|Progression-Free Survival (PFS) in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). PFS was defined as the time from the first dose of trial treatment to the first documentation of PD or death, whichever occurred first. PFS was calculated in months as [first event date minus first dose date plus 1] divided by 30.44.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||months||95% Confidence Interval|Median
1424893|NCT01056510|Secondary|Percentage of Participants Experiencing PD or Death in the First-Line Subpopulation|The criteria for PD are identified in previous outcome measure(s). The percentage of participants experiencing PD or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|End of Cycles 3 and 6 (both treatment arms), end of Cycles 7 to 12 (Rituximab + Chlorambucil arm), after an additional 8 weeks as confirmation of response, then every 3 months for 1 year, then every 6 months until study cutoff (up to 4.5 years)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
1424894|NCT01056510|Secondary|Percentage of Participants by Disease Response Category in the First-Line Subpopulation|The criteria for CR, CRi, PR, and nPR are identified in previous outcome measure(s). PD was defined by at least one of the following: the presence of lymphadenopathy; an increase in the previously noted enlargement of the liver or spleen by >/= 50% or the de novo appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by >/= 50% with >/= 5000 B-cells per microliter (B-cells/mcL); transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Participants not achieving a CR or PR, and who did not exhibit PD, were considered to have stable disease (SD). The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed. The rows below are labeled first by the level of response at the end of 6 cycles (C6), then by level of response at the confirmation assessment.|After 6 treatment cycles and at the confirmation of response assessment at least 12 weeks later (up to 36 weeks)|ITT Population (First-Line Subpopulation)|||percentage of participants|||Number
1424895|NCT01056510|Secondary|Percentage of Participants Achieving a Best Overall Response of CR, CR With Incomplete Marrow Recovery (CRi), Partial Response (PR), or Nodular PR (nPR) in the First-Line Subpopulation|The criteria for CR are identified in previous outcome measure(s). Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. The percentage of participants achieving each level of response was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|After 3 and 6 treatment cycles and from Baseline to the end-of-treatment (EOT) visit, completed within 10 days before cutoff for data collection|ITT Population (First-Line Subpopulation)|||percentage of participants||95% Confidence Interval|Number
1424896|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Second-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (Second-Line Subpopulation): A subset of participants requiring a second-line regimen for CLL.|||percentage of participants|||Number
1424897|NCT01056510|Secondary|Percentage of Participants Achieving Confirmed CR According to IWCLL 2008 Guidelines in the Pooled Population After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal CBC without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population|||percentage of participants|||Number
1424898|NCT01056510|Primary|Percentage of Participants Achieving Confirmed Complete Response (CR) According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines in the First-Line Subpopulation After 6 Cycles of Therapy|The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes less than (<) 4 times 10^9 cells per liter (cells/L); absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to chronic lymphocytic leukemia (CLL) involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils at least (>/=) 1.5 times 10^9 cells/L, platelets greater than (>) 100 times 10^9 cells/L, and hemoglobin > 11.0 grams per deciliter (g/dL); normocellular bone marrow (BM) aspirate with < 30 percent (%) lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. The percentage of participants achieving confirmed CR was calculated as the number of participants meeting the above criteria divided by the number of participants analyzed, multiplied by 100.|At least 2 months after completion of therapy (up to 32 weeks)|ITT Population (First-Line Subpopulation): A subset of participants requiring a first-line regimen for CLL.|||percentage of participants|||Number
1424899|NCT01056484|Primary|Time to Relapse (Resumption of Drinking)|Alcohol consumption as measured by time to relapse (resumption of drinking) from baseline to 26 weeks.|26 weeks|Only 105 participants provided data for this measure at 26-week follow up; due to participants either: declining participation for the visit, being unable to reach within the 26-week follow up time, or withdrawing from the study before 26-week follow up. Of the 105, 3 meditation/0 controls met criteria for having relapsed during this time frame.|||number of days to relapse||Standard Deviation|Mean
1424900|NCT01056484|Primary|Percent Days Abstinent From Alcohol|Measures percent days abstinent from alcohol|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.|||percent of days abstinent from alcohol||Standard Deviation|Mean
1424901|NCT01056484|Secondary|Subject Treatment Adherence|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention session attendance; adherence defined as attending 4 or more out of 8 total sessions.|8 weeks|"Of 64 enrolled participants, one withdrew prior to the first intervention session. This participant's data was included in the baseline data analyses; this participant's meditation intervention attendance was counted as 0."|||Percentage of meditation participants|||Number
1424902|NCT01056484|Secondary|Subject Treatment Satisfaction|Treatment satisfaction rating on a Likert scale of 1 to 7 (1 indicating 'extremely dissatisfied', 4 'neutral', and 7 'extremely satisfied').|8 weeks|48 participants provided data for this outcome measure at an 8-week follow up visit, and their responses were analyzed.|||points||Standard Deviation|Mean
1424903|NCT01056484|Secondary|Drinker Inventory of Consequences|Severity of drinking related negative consequences as measured by the Drinker Inventory of Consequences (DrInC-2R). This inventory consists of 50 items rated on a scale of 0 to 3, with '0' indicating a given consequence did not happen, '1' indicating it almost happened, '2' indicating it did happen, and '3' indicating it happened more than once. The sum of all ratings (minus the 5 control questions) indicates the 'total score', with higher scores corresponding to more drinking related consequences. The 'total score' can range from 0 (did not happen) to 135 (happened all the time).|26 weeks|Only 98 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.|||Scores on a scale||Standard Deviation|Mean
1424904|NCT01056484|Primary|Percent Heavy Drinking Days|Alcohol consumption as measured by percent heavy drinking days from baseline to 26 weeks. A heavy drinking day is defined as 4 or more drinks for women or 5 or more drinks for men, during a 24-hour period.|26 weeks|Only 105 participants provided data for this measure for the 26-week follow up visit. This was due to participants not providing data as a result of either: declining participation for that visit, being unable to reach within the 26-week follow up time frame, or withdrawing from the study before the 26-week follow up visit.|||percentage of heavy drinking days||Standard Deviation|Mean
1424905|NCT01056380|Secondary|Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza)||4 days|All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.|||Quantitative PCR RNA Copies||Standard Deviation|Mean
1424906|NCT01056380|Secondary|Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)||28 days|All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.|||hours||Inter-Quartile Range|Median
1424907|NCT01056380|Secondary|Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||Participants|||Count of Participants
1424908|NCT01056380|Secondary|Time Lost From Work (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||hours||95% Confidence Interval|Least Squares Mean
1424909|NCT01056380|Secondary|Overall Severity of Disease Score|Subjects recorded a severity score for 10 flu symptoms on a 0-3 scale BID for 7-14 days.The severity score for each symptom was multiplied by the number of hours scored at that severity for the entire time the subject maintained a diary (a sneezing score of 1 for 12 hours and 0 for 10 hours =1*12 + 0*10=12). This is symptom severity score*hours.Symptom severity score*hours for each of the symptoms were added for an overall symptom severity score*hours (if symptom severity score*hours for 10 symptoms were 12, 10, 9, 8, 7, 10, 10, 10, 5, 5, overall symptom severity score*hours=86).Overall symptom severity score*hours were divided by the number of hours that the subject kept a diary for a standardized continuous measure of severity of the course of illness (if overall symptom severity score*hours=86 and the subject maintained a diary for 100 hours Overall Severity of Disease Score=0.86). Overall Severity of Disease Score can range 0-30 with higher scores indicating more severe symptoms.|Up to 14 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||overall severity score||Standard Deviation|Mean
1424910|NCT01056380|Secondary|Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)||Up to 28 days|All subjects with laboratory confirmed influenza who received at least one dose of study medication.|||hours||Inter-Quartile Range|Median
1424911|NCT01056380|Secondary|Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)||Up to 28 days|All subjects who received at least one dose of study medication.|||hours||Inter-Quartile Range|Median
1424912|NCT01056380|Secondary|Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)||Up to 28 days|All subjects with any laboratory confirmed viral infection who took at least one dose of study medication.|||hours||Inter-Quartile Range|Median
1424913|NCT01056380|Primary|Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)||Up to 28 days|All subjects with laboratory confirmed influenza who took at least one dose of study medication.|||hours||Inter-Quartile Range|Median
1424914|NCT01056341|Secondary|Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.|Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits|6 months|||||||
1424915|NCT01056341|Primary|Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.||6 months|After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site.|||percentage of participants|||Number
1424916|NCT01056341|Primary|Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.||6 months|Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm.|||percentage of participants|||Number
1424917|NCT01056328|Secondary|Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs|Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)|12 months||||participants|||Number
1424918|NCT01056328|Secondary|Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period||12 months||||participants|||Number
1424919|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite.||12 months||||participants|||Number
1424920|NCT01056328|Primary|Incidence of Adverse Events Included in the Pre-specified Composite|Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.|7 days||||participants|||Number
1424921|NCT01056328|Primary|Confirmation of Entrance Block in the Pulmonary Veins||20 minutes after initial isolation||||participants|||Number
1424922|NCT01056315|Secondary|Assessment of Rescue Medication Usage During the 4-week Titration.||4-week titration phase|||||||
1424923|NCT01056315|Secondary|Time to Treatment Discontinuation Due to Lack of Efficacy.||Baseline to time to treatment discontinuation|||||||
1424924|NCT01056315|Secondary|Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|||||||
1424925|NCT01056315|Secondary|Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|||||||
1424926|NCT01056315|Secondary|EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|||||||
1424927|NCT01056315|Secondary|Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit).||Baseline, Day 29, Day 71 and Day 113.|||||||
1424928|NCT01056315|Secondary|Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit).||Day 29, Day 71 and Day 113.|||||||
1424929|NCT01056315|Secondary|Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit)||Baseline, weekly mean|||||||
1424930|NCT01056315|Secondary|Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit).||Baseline, weekly mean|||||||
1424931|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively.||Baseline, weekly mean|||||||
1424932|NCT01056315|Secondary|Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS).||Baseline; weekly mean|||||||
1424933|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance.||Baseline; daily scores over each week of maintenance|||||||
1424934|NCT01056315|Secondary|Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis).||Baseline, Last 7 days of 12-week maintenance|||||||
1424935|NCT01056315|Secondary|Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance||Baseline, Daily scores over entire 12 week maintenance|||||||
1424936|NCT01056315|Primary|Average Pain Intensity|The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).|Baseline; last 7 days of 12-week maintenance|||||||
1424937|NCT01056289|Secondary|Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms|Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population|||percentage of participants|||Number
1424938|NCT01056289|Secondary|Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase|Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period.|Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196)|Safety population (Double-blind phase): all participants who received at least 1 dose of study treatment and were randomized into the Double-blind treatment phase.|||percentage of participants|||Number
1424939|NCT01056289|Primary|Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase|Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2).|Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182)|Full Analysis Set (FAS): all randomized participants who had at least 1 postrandomization DESS record. Mean was adjusted for baseline DESS score and study center.|||scores on a scale||Standard Error|Mean
1424940|NCT01056276|Secondary|Overall Response Rate|The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.|every 4 weeks for approximately 2 years|All patients evaluable for response.|||participants|||Number
1424941|NCT01056276|Secondary|Overall Survival|Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive.|every 4 weeks until progressive disease then every 12 weeks, projected 48 months|All patients evaluable for response.|||months||95% Confidence Interval|Median
1424942|NCT01056276|Secondary|Progression Free Survival|Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater.|every 8 weeks for up to 48 months||||months||Full Range|Median
1424943|NCT01056276|Primary|Number of Patients Who Experienced Serious and Non-serious Adverse Events|All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms.|approximately 36 weeks|All patients who received at least one dose of BBD treatment.|||participants|||Number
1424944|NCT01056276|Primary|Complete Response Rate|Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow.|every 8 weeks for approximately 48 months|All patients evaluable for response.|||percentage of participants|||Number
1424945|NCT01056263|Primary|Overall Survival (OS)|Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact.|Baseline until death or up to Year 5|Full analysis set included all participants who received at least 1 dose of axitinib (AG-013736).|||Days||95% Confidence Interval|Median
1424946|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Control Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat|||square centimeters||Standard Deviation|Mean
1424947|NCT01056198|Post-Hoc|Change From Baseline in Wound Area - Santyl Treatment Group|Wound area at the end of treatment visit compared to the wound area at baseline for each subject|baseline and 28 days|Intent-to-treat|||square centimeters||Standard Deviation|Mean
1424948|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up||baseline and 84 days|Intent-to-Treat population|||percentage of baseline wound area||Standard Error|Mean
1424949|NCT01056198|Secondary|Percent of Wound Area Change From Baseline at End of Treatment||baseline and 28 days|Intent-to-Treat population|||percentage of baseline wound area||Standard Error|Mean
1424950|NCT01056198|Primary|Bates-Jensen Wound Assessment Score - Modified (BWAT-m)|The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).|baseline and 28 days|Intent-to-Treat population|||units on a scale||Standard Deviation|Mean
1424951|NCT01056107|Secondary|Stool Consistency Post Treatment|"The subjects rated their stool consistency using the 7-point Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea. The Bristol stool form was part of the bowel pattern diary, which was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study."|34 days (Visit 6)|Intent-to-treat|||units on a scale||Standard Error|Mean
1424952|NCT01056107|Secondary|Stool Frequency|Stool frequency was self reported in a Bowel Pattern Diary. The bowel pattern diary was dispensed at the screening visit, and the completed bowel pattern diary was collected at the completion of the study.|screening visit (Visit 1), 34 days (Visit 6)|Intent-to-treat|||Stools/day||Standard Error|Mean
1424953|NCT01056107|Secondary|Colonic Transit, Colonic Geometric Center at 48 h Measured by Scintigraphy, as Compared to Placebo.|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours (Visit 4 = Day 2)|Intent-to-treat|||units on a scale||Standard Error|Mean
1425064|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27|The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
1424956|NCT01056107|Secondary|Colonic Geometric Center at 4 h Measured by Scintigraphy|"The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. (Note: when there is no radio isotope in the colon (e.g., at 4 hours) the geometric center values are recorded as zero, thus the mean values can be less than one.)"|4 hours (Visit 2 = Day 0)|Intent-to-treat|||units on a scale||Standard Error|Mean
1424957|NCT01056107|Secondary|Gastric Residual at 2 and 4 Hours Measured by Scintigraphy|The gastric residual will be calculated as the proportion of isotope remaining in the stomach (at 2 and 4 hours).|2 hours, 4 hours (Visit 2 = Day 0)|Intent-to-treat|||proportion of isotope in the stomach||Standard Error|Mean
1424958|NCT01056107|Primary|Half Time (t1/2) of Gastric Emptying of Solids Measured by Scintigraphy (Gastric Transit)|Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.|approximately 2 hours after radiolabeled meal is ingested (Visit 2 = Day 0)|Intent-to-treat|||minutes||Standard Error|Mean
1424959|NCT01056107|Primary|Change Between Postprandial and Fasting Whole Gastric Volume by Technetium-99m (99mTc)-SPECT Imaging (Gastric Accommodation)|"A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the fasting volume and 2 postprandial volumes were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation)."|approximately 1 hour after 99mTC injection, approximately 30 min after liquid meal (Visit 5 = approximately 2-10 days after Visit 4)|Intent-to-treat|||mL||Standard Error|Mean
1424960|NCT01056107|Primary|Colonic Transit, Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours (Visit 3 = Day 1)|Intent-to-treat|||units on a scale||Standard Error|Mean
1424961|NCT01056016|Primary|Physician ADHD Practice Behavior|Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response|Baseline and 6 months|Patient chart reviews were conducted with 174 patients in the ADHD Collaborative Intervention group and 64 patients in the Wait-list control group|||percentage of patients||Standard Deviation|Mean
1424962|NCT01055886|Other Pre-specified|Diary Ratings of Cravings|"Participants provided (through ecological momentary assessment) ratings of their smoking craving. This outcome reflects differences between ad lib (or typical) smoking craving compared to smoking craving reported during the pre-quit period. Craving was reported from a single item Please indicate your desire/craving to smoke, and answers were provided in a 5-point Likert scale where 1=no craving and 5=severe craving. Higher scores are presumed to be worse because they indicate increased craving, which is likely to lead to non-abstinence."|During pre-quit period; two weeks|61 participants provided this EMA data during the pre-quit period.|||units on a scale||Standard Error|Mean
1424963|NCT01055886|Secondary|Abstinence as Measured by Exhaled Carbon Monoxide (CO)|This outcome reflects the number of participants whose exhaled carbon monoxide (CO; a measure of smoking) indicated abstinence (i.e., 6 parts per million or less) at Session 12, which occurred six weeks post-quit.|Session 12, 6 weeks post-quit|Data was available on 30 participants who attended Session 12.|||participants|||Number
1424964|NCT01055886|Primary|Participants Self-reporting Abstinence During 6 Weeks Post Quit|In the 6 week post-quit period, participants completed ecological momentary assessment (EMA), or diary, ratings of their smoking behavior. This outcome reflects the number of participants who reported not relapsing (i.e., smoking 7 days in a row) during the 6 weeks post-quit.|6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12|37 participants completed the ecological momentary assessment (EMA; diary) ratings during the post-quit period.|||participants|||Number
1424965|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.|||ng*hr/mL||Standard Deviation|Mean
1424966|NCT01055834|Primary|Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups.|||ng/mL||Standard Deviation|Mean
1424967|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])|Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.|||ng*h/mL||Standard Deviation|Mean
1424968|NCT01055834|Primary|Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)|Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose).|immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose|Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1.|||ng/mL||Standard Deviation|Mean
1424969|NCT01055782|Secondary|Perception of Pain|VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale|After endoscopy (within 10mins) and 1 day after endoscopy||||Scores on a scale 0-10||Standard Deviation|Mean
1424970|NCT01055782|Primary|Completed Colonoscopy||immediately after colonoscopy|Choosen by randomization.|||participants|||Number
1424971|NCT01055769|Secondary|Terminal Half-Life (t1/2)|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||hours||Standard Deviation|Mean
1424972|NCT01055769|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The time of the first occurrence of peak concentration observed directly from data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||hours||Full Range|Median
1424973|NCT01055769|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||mcg*h/mL||Standard Deviation|Mean
1424974|NCT01055769|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration within the dosing interval was directly obtained from the concentration-time data.|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
1424975|NCT01055769|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).|0, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic concentration population: all randomized and treated participants who had at least 1 concentration in at least 1 treatment period.|||microgram*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
1424976|NCT01055704|Secondary|Stool Consistency as Reported From the Bristol Stool Scale|"Bristol Stool Scale a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5–7 tending towards diarrhea."|Daily||||Units on a scale||Standard Error|Mean
1424977|NCT01055704|Secondary|Stool Frequency|Stool frequency was self reported in a daily bowel pattern diary for 13 days.|daily||||Stools||Standard Error|Mean
1424978|NCT01055704|Secondary|Colonic Filling at 6 Hours|Percent of solids reaching the colon at 6 hours|6 hours||||Percentage||Standard Error|Mean
1424979|NCT01055704|Secondary|Colonic Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|48 hours||||Units on a scale||Standard Error|Mean
1424980|NCT01055704|Secondary|Colonic Geometric Center at 4 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|4 hours||||Units on a scale||Standard Error|Mean
1424981|NCT01055704|Secondary|T1/2 of Gastric Emptying of Solid||4 hours||||Minutes||Standard Error|Mean
1424982|NCT01055704|Secondary|T1/2 of Ascending Colon Emptying||24 hours||||hours||Standard Error|Mean
1424983|NCT01055704|Primary|Colonic Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours||||Units on a scale||Standard Error|Mean
1424984|NCT01055639|Secondary|Pittsburgh Sleep Quality Index|The 19-item Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is the most commonly used measure of self-rated sleep quality, with good reliability (alpha = .83, test-retest = .85) and validity (kappa = 0.75) for distinguishing good and poor sleepers. A survey recently conducted by the IMMPACT group indicated that sleep is one of the domains most important to patients with chronic pain (Turk et al., 2008), and the PSQI is the scale most frequently used to evaluate sleep quality in studies of chronic pain patients (Cole et al., 2007). Scores range from 0 (good sleep) to 42 (poor sleep).|8 weeks||||units on a scale||Standard Deviation|Mean
1424985|NCT01055639|Secondary|PTSD Checklist|The 17-item PTSD Checklist (Weathers et al., 1994) will be used to assess PTSD symptoms. In combat veterans, this questionnaire has high test-retest reliability (0.96) and validity as indicated by a kappa of 0.64 for diagnosis of PTSD using the SCID (Weathers et al., 1993). Scores range from 17 (low PTSD) to 85 (high PTSD).|8 weeks||||units on a scale||Standard Deviation|Mean
1424986|NCT01055639|Secondary|Pain Anxiety Symptom Scale - 20|Anxiety will be assessed with the 20-item Pain Anxiety Symptoms Scale-Short Form (PASS-20; McCracken & Dhingra, 2002). Pain anxiety captures fears patients associate with their symptoms, which are typically associated with the belief that their pain signals harm. High levels of pain anxiety compromise patient’s activity levels, participation in rehabilitation, and performance on functional tests. The instrument is a valid and reliable measure of anxiety symptoms in pain populations (McCracken et al., 1996; Roelofs et al., 2004). The PASS-20 items are scored on a 6-point Likert scale and assess cognitive, escape/avoidance, fear, and physiological anxiety dimensions. Internal consistency is high and correlation between the short and long form is excellent (alpha=.81; r=.97). This measure has been recommended by the VA and demonstrated sensitivity to treatment in the pilot sample (National VA Pain Outcomes Working Group, 2003). Scores range from 0 (least anxiety) to 100 (most anxiety).|8 weeks||||units on a scale||Standard Deviation|Mean
1424987|NCT01055639|Secondary|Patient Health Questionnaire-9|The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the scoring severity index. Scores range from 0 (lowest level of depressive symptoms) to 27 (highest level of depressive symptoms).|8 weeks||||units on a scale||Standard Deviation|Mean
1424988|NCT01055639|Secondary|SF-12 PCS|Physical health-related quality of life will be measured using the Physical Component Summary score of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks||||units on a scale||Standard Deviation|Mean
1424989|NCT01055639|Secondary|SF-12 MCS|6-item self-report measure of mental health-related quality of life. Subscale of the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12; Ware et al., 1994). This measure is widely used with populations with chronic disease. The Physical and Mental Component Summary scores correlate .91 and .92 with the corresponding scores derived from the SF-36, and 2-week test-retest reliability correlations were .89 and .76 (Ware et al., 1994). The Short Form Health Survey is recommended by the IMMPACT group (Dworkin et al., 2005). Scores range from 0 (lowest functioning) to 100 (highest functioning).|8 weeks||||units on a scale||Standard Deviation|Mean
1424990|NCT01055639|Secondary|West Haven-Yale Multidimensional Pain Inventory - Activity Subscales|The West Haven-Yale Multidimensional Pain Inventory (MPI; Kerns et al., 1985) contains 52 items forming 12 subscales. For this study, we used four subscales assessing various types of activities. Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items). The MPI has been used extensively in outcome research with heterogeneous samples of chronic pain patients, including veterans, and has demonstrated sensitivity to treatment change (Altmaier et al., 1992; Mikail et al., 1993). Individual items are rated on a 7-point Likert scale from 0-6, and subscales are scored by averaging items together. Therefore, the score for Part III, General Activity, is composed of an average of the 18 items in the Household Chores (5 items); Outdoor Work (5 items); Activities Away From Home (4 items); and Social Activities (4 items) subscales. The final score ranges from 0 (lowest level of activity) to 6 (highest level of activity).|8 weeks||||units on a scale||Standard Deviation|Mean
1424991|NCT01055639|Secondary|Brief Pain Inventory-severity Subscale|The Brief Pain Inventory Short Form (BPI; Cleeland & Ryan, 1994) includes a 4-item pain severity subscale measuring the level of pain over the past week on average, at its worst, at its least, and currently. This measure is recommended by the IMMPACT group as a pain assessment tool (Dworkin et al., 2005). Scores range from 0 (least pain severity) to 10 (most pain severity).|8 weeks||||units on a scale||Standard Deviation|Mean
1424992|NCT01055639|Primary|Brief Pain Inventory-interference Subscale|The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland & Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).|8 weeks||||units on a scale||Standard Deviation|Mean
1424993|NCT01055613|Primary|Distance Visual Acuity (LogMAR)|Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.|Up to 3 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR|Subject Eyes|Standard Deviation|Mean
1424994|NCT01055613|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.|3 months|The analysis population consists of all subjects that were dispensed a solution during the course of the study.|||Subjects Eyes|Subject Eye's||Number
1427122|NCT01033825|Secondary|Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.|Ratio of correct advance is defined as the (number of doses actuated/number of dose reported).|Weeks 1-2, 2-4|Intent to Treat Population|||percentage of correct advances||Standard Deviation|Mean
1424996|NCT01055457|Primary|Slit Lamp Findings (SLF)|Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.|Up to 3 months Post Lens Wear|All subjects that completed the study.|||eyes (2 per subject)|Subject eyes||Number
1424997|NCT01055314|Secondary|Response Rate (CR + PR)|Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.|From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities|20 participants were excluded because of ineligibility or absence in overall response evaluation.|||Proportion of Participants||95% Confidence Interval|Number
1424998|NCT01055314|Primary|Event-Free Survival|Probability of no relapse, secondary malignancy, or death after 3 years in the study.|3 years|9 participants who were ineligible or did not receive treatment were excluded.|||Probability||95% Confidence Interval|Number
1424999|NCT01055314|Primary|Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.|Up to 54 weeks|9 participants who were ineligible or did not receive treatment were excluded.|||Participants|||Number
1425000|NCT01055314|Primary|Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment|Proportion of no Grade 4+ non-hematologic toxicity.|From start to week 26 of therapy|13 participants were excluded because of ineligibility or insufficient information to assess feasibility.|||Proportion of Participants||95% Confidence Interval|Number
1425001|NCT01055314|Primary|Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment|Proportion of no Grade 3+ cardiac toxicity.|From start to week 26 of therapy|18 participants were excluded because of ineligibility or insufficient information to assess feasibility.|||Proportion of Participants||95% Confidence Interval|Number
1425002|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day|Skin assessments performed after 4 hours of wear, participants discontinued wrap wear for remainder of day (4 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Erythema grading scale: 7 point scale ranging from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda and follicular response.|Baseline to Day 6|Safety Population|||Percentage of participants|||Number
1425003|NCT01055262|Secondary|Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day|Skin assessments performed prior to heatwrap application; participant discontinued wrap wear for day (8 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Outcome included those who discontinued wrap wear by 4 hours on same day. Erythema grading scale: 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response.|Baseline to Day 6|Safety Population|||Percentage of participants|||Number
1425004|NCT01055262|Secondary|Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation|Participants discontinued study due to adverse event (AE) if erythema ≥ 2.0, pain upon touch associated with non-zero erythema score or elevated response on the morning of Day X+1. Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Baseline to Day 6|Safety population; N = participants with a non-zero erythema score or elevated response leading to study discontinuation.|||Days||Standard Deviation|Mean
1425005|NCT01055262|Secondary|Time to First Report of Non-zero Erythema Score or Elevated Response|Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Baseline to Day 6|Safety population; N = participants with any application site finding|||Days||Standard Deviation|Mean
1425006|NCT01055262|Secondary|Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)|Events associated with Day X wear (eg, Day 5) assessed on the morning of Day X+1 (eg, Day 6). Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.|Day 2 to Day 6|Safety Population|||Percentage of participants||95% Confidence Interval|Number
1425007|NCT01055262|Secondary|Time to First Significant Skin Event|Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Baseline to Day 6|Safety population; Number of participants analyzed (N) = number of participants with significant skin event.|||Days||Standard Deviation|Mean
1425065|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0|The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
1440912|NCT00928395|Secondary|GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.||every three months for 36 months|||||||
1425008|NCT01055262|Secondary|Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)|Events associated with Day X wear (eg, Day 4) assessed on the morning of Day X+1 (eg, Day 5). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Day 2 to Day 5|Safety population|||Percentage of participants||95% Confidence Interval|Number
1425009|NCT01055262|Primary|Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)|Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter [cm] diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked “Does your skin hurt when I touch it?”|Day 2 to Day 6|Safety population: participants who wore the product at least once during the study|||Percentage of participants||95% Confidence Interval|Number
1425010|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
1425011|NCT01055223|Secondary|Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
1425012|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
1425013|NCT01055223|Secondary|Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
1425014|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008|The study population consisted of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.|||fractures|||Number
1425015|NCT01055223|Primary|Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD|ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.|From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 and December 31, 2008|Type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.|||fractures|||Number
1425016|NCT01055197|Secondary|Evaluation of the Percentage of the Planned Radiotherapy Dose to Each Site||From start to end of radiation therapy.|||||||
1425017|NCT01055197|Secondary|Comparison of Time to First Failure||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|||||||
1425018|NCT01055197|Secondary|Patterns of Failure||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|||||||
1425019|NCT01055197|Secondary|Comparison of Treatment-related Adverse Events||From start of treatment to end of follow-up.|||||||
1425020|NCT01055197|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1425021|NCT01055184|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|day 0 to day 7 post vaccination||||participants|||Number
1425022|NCT01055171|Secondary|Proportion of Drinking Days|Proportion of drinking days from 90 days prior to the screening to the follow-up period.|90 days prior to participation in study up to 2-week follow up session (Session 3)||||Drinking days||Standard Error|Mean
1425023|NCT01055171|Primary|Test Session Craving Scores (Session 2)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during test session (Session 2)||||units on a scale||Standard Error|Mean
1425024|NCT01055171|Primary|Test Session Distress Scores (Session 2)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during test session (Session 2)||||units on a scale||Standard Error|Mean
1425025|NCT01055171|Primary|Retrieval Session Craving Scores (Session 1)|Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving for alcohol.|Multiple times throughout cue exposure during retrieval session (Session 1)||||units on a scale||Standard Error|Mean
1425026|NCT01055171|Primary|Retrieval Session Distress Scores (Session 1)|Found by using our Single Item Distress (SID) scale. A study team member asks the participant to verbally report the level of distress they were experiencing using values between 0 and 100, with 0 representing no distress and 100 extreme distress.|Multiple times throughout cue exposure during retrieval session (Session 1)||||units on a scale||Standard Error|Mean
1425027|NCT01055132|Primary|Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||units on a scale||Standard Deviation|Mean
1425028|NCT01055132|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire|The Contact Lens User Evaluation(CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3*SD).|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||units on a scale||Standard Deviation|Mean
1425029|NCT01055132|Primary|Binocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||LogMAR||Standard Deviation|Mean
1425030|NCT01055132|Primary|Monocular Visual Acuity on LogMAR Scale|Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.|After 5 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study.|||logMAR||Standard Deviation|Mean
1425031|NCT01055028|Secondary|Overall Survival (OS) at 12 Months|Assessed as the number of subjects known to remain alive 12 months after study entry|12 months||||Participants|||Count of Participants
1425032|NCT01055028|Secondary|Overall Survival (OS) at 6 Months|Assessed as the number of subjects known to remain alive 6 months after study entry|6 months||||Participants|||Count of Participants
1425033|NCT01055028|Secondary|Overall Response Rate After 6th Cycle|"Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 6 cycles of treatment (24 weeks) is expressed as the number and proportion of subjects.~RECIST Criteria~CR = Disappearance of all target lesions~PR = ≥ 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s),~Stable disease (SD) = Small changes that do not meet any of the above criteria"|6 Cycles|Includes participants that complete 6 cycles of treatment|||Participants|||Count of Participants
1425034|NCT01055028|Secondary|Overall Response Rate After 3 Cycles|"Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 3 cycles of treatment (12 weeks) is expressed as the number and proportion of subjects.~RECIST Criteria~CR = Disappearance of all target lesions~PR = ≥ 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s),~Stable disease (SD) = Small changes that do not meet any of the above criteria"|12 weeks|Includes participants that complete 3 cycles of treatment|||Participants|||Count of Participants
1425035|NCT01055028|Primary|Progression-free Survival (PFS)|"The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment.~Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s)."|4 months|Includes all subjects that started treatment|||Participants without disease progression|||Number
1425036|NCT01054976|Secondary|Change From Baseline in Seoul-Instrumental Activities of Daily Livings (S-IADL)|The Seoul-Instrumental Activities of Daily Living (S-IADL) assesses patients' abilities to perform instrumental and social activities of daily living. These include the ability to prepare a balanced meal, remember appointments, keep financial records, remember to take medication, and so on. It is composed of 15 items, with scores ranging from 0 to 45. Lower scores indicate better functioning.|Baseline, Week 12|Intention-to-Treat analysis set.|||scores on a scale||Standard Deviation|Mean
1425037|NCT01054976|Secondary|Change From Baseline in Korean Version of Disability Assessment for Demential Scale (DAD-K)|"DAD-K is the Korean version of the Assessment for Dementia Scale, a tool developed to evaluate the Alzheimer patients' function including both basic and instrumental Activities of Daily Livings (ADL). It evaluates one function from various perspectives including behavior initiation, plan and preparation, and valid performance. It consists of 10 questions, each can score either 0 (no) or 1 (yes), if not applicable, patient will check on not applicable (x) which will not count in the calculation. Scores range from 0 to 100. Higher score represents better function"|Baseline, Week 12|Intention-to-Treat analysis set.|||scores on a scale||Standard Deviation|Mean
1425038|NCT01054976|Secondary|Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)|The Alzheimer's disease Assessment Scale-Cognitive subscale (ADAS-Cog) is an instrument used to assess cognitive dysfunction in individuals with Alzheimer disease and other dementias. It consists of 11 items, with scores ranging from 1 to 70. Maximum score is 70. Higher scores indicate worsening.|Baseline, Week 12|Intention-to-Treat analysis set.|||scores on a scale||Standard Deviation|Mean
1425039|NCT01054976|Primary|Change From Baseline in Choice Reaction Time|The Choice Reaction Time is a computerized attention test that evaluates the reaction time and the number of errors by showing patients one card on the computer screen and making them find the same one among similar four cards. The test is performed a total of 12 times.|Baseline, Week 12|Per-protocol (PP) analysis set.|||seconds||Standard Deviation|Mean
1425040|NCT01054976|Primary|Change From Baseline in Simple Reaction Time|The Simple Reaction Time is a computerized attention test that evaluates the patient’s reaction time when the color of the computer screen changes from black to white by performing a total of 70 times for six minutes.|Baseline, Week 12|Per-protocol (PP) analysis set.|||seconds||Standard Deviation|Mean
1425041|NCT01054911|Secondary|Alteration in Diffusion and Vascularity Kinetics|The Response Evaluation Criteria in Solid Tumors (RECIST) criteria may be insensitive in assessing GIST so the Choi criteria will be used. The Choi criteria accounts for morphologic tumor changes and biologic alterations. Diffusion-weighted magnetic resonance imaging (MRI) and dynamic contrast magnetic resonance will be used to find the vascular permeability and apparent diffusion coefficient 9ACD) at baseline, Week 2 and Week 6. Weeks 2 and 6 values will be compared to the baseline values using paired t tests.|MRI at baseline, Week 2 and Week 6|Data were not collected||||||
1425042|NCT01054911|Secondary|Measurable Disease Response Rate|Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed|FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12|Data were not collected.||||||
1425043|NCT01054911|Primary|Number of Participants With Adverse Events||6 months||||participants|||Number
1425044|NCT01054885|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
1425045|NCT01054885|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.|||Liters||Standard Error|Least Squares Mean
1425046|NCT01054885|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an ‘Other’ endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Scores on a scale||Standard Error|Least Squares Mean
1425047|NCT01054885|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
1425048|NCT01054885|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
1425049|NCT01054846|Secondary|Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners|Number of injuries by helmet wearing status as reported|5 months|Analysis population includes all participants that owned a helmet and available data for this assessment|||Injuries|||Number
1425050|NCT01054846|Primary|Percentage of Participants Wearing Helmet||Baseline (Survey 1) and 5 months (Survey 2)|Analysis reflect population that owned the helmet during each survey|||Percentage of Participants|||Number
1425766|NCT01048424|Secondary|Percent Change in Any Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks||||Percent Change||Standard Deviation|Mean
1425053|NCT01054820|Secondary|Mean Change From Baseline to EOT in Beck Depression Inventory® Il|The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and >40=extreme depression.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; End-of-Treatment score was the most recent non-missing value.|||scores on a scale||Standard Deviation|Mean
1425054|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator|Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population|||participants|||Number
1425055|NCT01054820|Secondary|Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant|Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.|End of Treatment (up to Day 15)|ITT population|||participants|||Number
1425056|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation.|||percent||Standard Deviation|Mean
1425057|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
1425058|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
1425059|NCT01054820|Secondary|Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
1425060|NCT01054820|Secondary|Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.|Baseline, End of Treatment (last visit up to Day 15)|ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.|||participants|||Number
1425061|NCT01054820|Primary|Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours|Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, End of Treatment (last visit up to Day 15)|Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.|||scores on a scale||Standard Deviation|Mean
1425062|NCT01054742|Primary|Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study|A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.|From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1, Part 2 of the study, and who consented to retreatment.|||participants|||Number
1425063|NCT01054729|Secondary|Percentage of Participants Who Developed Resistance to Sofosbuvir||Baseline to Week 4|Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.|||percentage of participants|||Number
1439468|NCT00939185|Secondary|Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital|Time of exam completion minus the start time of the examination.|Day 1|Safety population|||minutes||Full Range|Median
1425067|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-566500: Cmax at Day 0|The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
1425068|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27|The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
1425069|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0|The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
1425070|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 27|The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
1425071|NCT01054729|Secondary|Plasma Pharmacokinetics of GS-331007: Cmax at Day 0|The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
1425072|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27|"The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir).~AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
1425073|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0|"The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir).~AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||h*ng/mL||Standard Deviation|Mean
1425074|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27|The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
1425075|NCT01054729|Secondary|Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0|"The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir.~Cmax is defined as the maximum concentration of drug."|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose|Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.|||ng/mL||Standard Deviation|Mean
1425076|NCT01054729|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment|SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA < LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).|Post-treatment Weeks 12 and 24|Safety Analysis Set|||percentage of participants|||Number
1425077|NCT01054729|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4|Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.|Week 4|Safety Analysis Set|||percentage of participants|||Number
1425078|NCT01054729|Secondary|Change in Circulating HCV RNA at Week 4||Baseline to Week 4|Safety Analysis Set|||log10 IU/mL||Standard Deviation|Mean
1425079|NCT01054729|Primary|Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period|Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline to Week 4|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
1425080|NCT01054703|Secondary|Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures||1 wk, 2wk, 4wk, 6wk|||||||
1425081|NCT01054703|Primary|Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant||Procedural and 6 weeks post-implant||||participants|||Number
1425082|NCT01054625|Secondary|Apparent Volume of Distribution at Steady State||8 weeks||||L||Geometric Coefficient of Variation|Geometric Mean
1425083|NCT01054625|Secondary|Apparent Volume of Distribution During the Terminal Phase||8 weeks||||L||Geometric Coefficient of Variation|Geometric Mean
1425084|NCT01054625|Secondary|Clearance||8 weeks||||L/h||Geometric Coefficient of Variation|Geometric Mean
1425085|NCT01054625|Secondary|Elimination Half-life||8 weeks||||h||Geometric Coefficient of Variation|Geometric Mean
1425086|NCT01054625|Secondary|Area Under Curve 0-21 Days||0-21 days||||h mg/L||Geometric Coefficient of Variation|Geometric Mean
1425087|NCT01054625|Secondary|Area Under Curve 0-7 Days||0-7 days||||h mg/L||Geometric Coefficient of Variation|Geometric Mean
1425088|NCT01054625|Primary|Maximum Plasma Concentration of Zalutumumab After Fourth Infusion|PK samples are taken: pre and post infusion on days 0, 14, 21 and 28 plus at +3 and +12 hours on days 0 and 28. A single PK sample is taken on days between these treatments and 8 more are taken over 3 weeks after treatment on day 28.|Pre and post infusion after weekly administration of zalutumumab during 28 days||||mg/L||Geometric Coefficient of Variation|Geometric Mean
1429628|NCT01012414|Secondary|Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A||1 year|Data were not collected when study was stopped prematurely.||||||
1425089|NCT01054599|Secondary|A Secondary Analysis Will Examine the Possible Sustained Benefit of Continued Memantine Use.|SRT-CLTR (range 0-72; higher scores indicate better memory), and 7-24 Spatial Memory Test (range 0-35; scores are summed across the 5 learning trials, with higher scores indicating better memory) scores will be assessed across the first (baseline) and third (post-open label memantine) testing sessions. These measures are considered to be scores on a scale, rather than standard units. The hypothesis was that subjects randomized to memantine would demonstrate sustained improvement from baseline, while the placebo group would demonstrate improvements after taking open label memantine (compared to baseline).|26 weeks|This analysis included only those subjects who participated in the open label extension period.|||scores on a scale||Standard Deviation|Mean
1425090|NCT01054599|Secondary|To Test the Hypothesis That Treatment With Memantine Will Result in Subjective Improvement of Memory Function, the Change Scores From the QOLIE-89 Will be Evaluated.||5 years||2017-12-31|12/2017||||
1425091|NCT01054599|Secondary|To Test the Hypothesis That Improvement Will be Selective for Verbal Memory, Change Scores on the Non-verbal Tasks Will be Compared Between the Placebo and Memantine Treatment Groups.||5 years||2017-12-31|12/2017||||
1425092|NCT01054599|Primary|The Change Scores in Memory Measures From Baseline to Post-treatment/Placebo Will be Compared Between the Memantine Treatment and Placebo Groups.|Change scores from pre- to post-treatment/placebo were calculated for the primary outcome measures, the Selective Reminding Test Continuous Long-Term Retrieval (range 0-72; higher scores indicate better memory) and 7-24 Spatial Recall Test Total Learning (range 0-35; total correct across 5 learning trials are summed, with higher scores indicating better memory) scores. These measures are scores on a scale, rather than representing standard units.|13 weeks|The analysis includes subjects who completed both sessions 1 (baseline) and 2 (post-treatment/placebo). One subject in the memantine group completed both sessions, but the data were excluded from analysis due to seizures occurring during testing sessions 1 and 2, yielding n=8 in the memantine group.|||scores on a scale||Standard Deviation|Mean
1425093|NCT01054586|Other Pre-specified|Median Bilirubin Level at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||milligrams (mg)/deciliter (dl)||Full Range|Median
1425094|NCT01054586|Other Pre-specified|Median Blood Platelet Count at Baseline|Participant characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||10^9/liter||Full Range|Median
1425095|NCT01054586|Secondary|Incidence Rates Per 100 Person-years of Follow-up (PYFU) of Study Main Outcome Measures|Incidence rates per 100 person-years of follow-up of study primary outcome. The numbers analyzed in the category titles represent the number of patients with each event. Incidence rate is the number of new cases per population in a given time period, where the denominator is the sum of the person-time of the at-risk population.|Incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||incidence rate|||Number
1425096|NCT01054586|Secondary|Number of Participants for Which the Reason for Discontinuation of One or More Drugs in the FPV/RTV or LPV/RTV Regimen Was Due to Adverse Events Only|Number of participants for which the reason for discontinuation of one or more drugs in the FPV/RTV or LPV/RTV regimen was due to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available)|The incidence of these events was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||participants|||Number
1425097|NCT01054586|Secondary|Number of Participants With the Indicated Major Reasons for Discontinuing One or More Drugs in the FPV/r or LPV/r Regimen|Major reasons for discontinuing one or more drugs in the FPV/r or LPV/r regimen|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||participants|||Number
1425098|NCT01054586|Secondary|Number of Participants Who Discontinued the Indicated Antiretrovirals for the First Time After Starting FPV/r or LPV/r|Antiretrovirals discontinued for the first time after starting FPV/r or LPV/r|Assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||participants|||Number
1425099|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to the Indicated Adverse Events|Defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only. Adverse events can only be attributed to the body system stated (no further specificity is available).|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425100|NCT01054586|Secondary|Number of Events of Discontinuation of One or More Drugs in the FPV/RTV- or LPV/RTV Regimen Due to Adverse Events Only|Defined as the occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attributed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425101|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425102|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for FIB-score and Other Variables|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425103|NCT01054586|Secondary|Number of Events of First Discontinuation of One or More Drugs Included in the FPV/RTV- or LPV/RTV-based Regimen by Treatment Group, Controlling for APRI-score and Other Variables (See Comments)|A first discontinuation is defined as the first occurrence of stopping one or more drugs in the FPV/RTV or LPV/RTV-based regime|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1429629|NCT01012414|Primary|Change in High Sensitivity-C Reactive Protein (Serum)||1 year|Data were not collected when study was stopped prematurely.||||||
1425104|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone Due to Adverse Events Only|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV; where the reason for stopping is attritubed to adverse events only|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425105|NCT01054586|Other Pre-specified|Median ALT and AST Scores at Baseline|Participants characteristics at baseline according to treatment group.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||IU/L (International Units per Liter)||Full Range|Median
1425106|NCT01054586|Other Pre-specified|Median Model of End-stage Liver Disease (MELD) Score at Baseline|MELD is a scoring system for assessing the severity of chronic liver disease and is used to predict participant survival. It is calculated using biochemical values as follows: MELD = (0.957 x Log[Creatinine]) + (0.378 x Log[Bilirubin]) + (1.120 x Log[INR]) + 0.6431. INR = International Normalized Ratio for prothrombin time. MELD scores range between 0 and 40, with 40 being the most severe, i.e., 100% mortality. In interpreting the MELD score in hospitalized participants, the 3-month mortality is: score >=40, 100% mortality; 30–39, 83% mortality; 20–29, 76% mortality; 10–19, 27% mortality.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe. MELD scores are not available for the “FPV 700 mg BID/RTV 100 mg QD” group due to missing data.|||MELD score||Full Range|Median
1425107|NCT01054586|Other Pre-specified|Median FIB (a Model of End-stage Liver Disease) Score at Baseline|The FIB-4 score is an index that combines biochemical values (platelets, ALT, AST) and age to determine the degree of hepatic fibrosis. FIB-4 = (Age x AST)/(Platelet counts x ALT1/2). The FIB-4 score ranges between values of 0 to 13. A score of <1.45 indicates no/moderate fibrosis (F0-F1-F2-F3 in the ISHAK classification of fibrosis), whereas a score >3.25 is indicative of extensive fibrosis or cirrhosis (F4-F5-F6). The ISHAK classification of fibrosis is a commonly used scoring system that stages fibrosis from 0-6 (1-2, portal fibrotic expansion; 3-4, bridging fibrosis; 5-6, cirrhosis).|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||FIB Score||Full Range|Median
1425108|NCT01054586|Other Pre-specified|Median Aspartate Aminotransferase (AST)-Platelet Ratio Index (APRI) Score at Baseline|The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. It is calculated as follows: APRI score = ([AST level/Upper Limit Normal]/Platelet counts) x 100. AST = Aspartate aminotransferase. In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||APRI Score||Full Range|Median
1425109|NCT01054586|Other Pre-specified|Cluster of Differentiation (CD4) Count at Baseline|Participant characteristics at baseline according to treatment group. CD4 count is a measurement of how many functional CD4 T-cells are circulating in the blood. The lower the absolute CD4 count, the weaker the immune system.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||cells/microliter (μl)||Full Range|Median
1425110|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV- or LPV/RTV Alone by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425111|NCT01054586|Other Pre-specified|Median Length of Participant Follow-up and Length of Time on Antiretroviral Therapy (ART) at Baseline|Participant characteristics at baseline are presented according to treatment group. ART is used for the treatment of HIV.|Baseline|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||years||Full Range|Median
1425112|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for FIB-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425113|NCT01054586|Secondary|Number of Events of First Discontinuation of FPV/RTV or LPV/RTV Alone by Treatment Group, Controlling for APRI-score, and Other Variables|A first discontinuation is defined as the first occurrence of stopping FPV/RTV or LPV/RTV.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425114|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for Current Values of CD4 and Platelet Counts|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425115|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for FIB-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence was assessed over time during Year 1|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425116|NCT01054586|Primary|Number of Events of an Elevation in ALT After Baseline by Treatment Group, Controlling for APRI-score, and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|Incidence of these events was assessed over time during Year 1, censoring patients' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425117|NCT01054586|Primary|Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables|An elevation in ALT is defined as a single value >200 IU/I.|The incidence of these events was assessed over time during Year 1, censoring participants' follow-up at date of last ALT|HIV/hepatitis virus co-infected participants enrolled in a number of cohort studies in Europe|||events|||Number
1425118|NCT01054573|Secondary|Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level|The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||log 10 IU/ml||Full Range|Median
1425119|NCT01054573|Secondary|Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time|The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.|Baseline, Weeks 4, 8, 12, 24, 36, 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Log 10 IU/mL||Full Range|Median
1425120|NCT01054573|Secondary|Percentage of Participants Who Relapsed During Follow-Up|The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).|During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)|The analysis was performed on the full analysis (FA) set, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.|||Percentage of participants|||Number
1425121|NCT01054573|Secondary|Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase.|Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1425122|NCT01054573|Secondary|Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)|The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).|Weeks 4 and 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1425123|NCT01054573|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1425124|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36|The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL.|Week 12 or Weeks 24 or 36|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1425125|NCT01054573|Secondary|Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8|The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL.|Week 4, Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
1425126|NCT01054573|Secondary|The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points|The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.|Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants with response|||Number
1425127|NCT01054573|Primary|The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)|The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.|End of trial (24 weeks after last dose, administerd at 48 weeks)|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants with response|||Number
1425128|NCT01054560|Primary|Procedure-related Serious Adverse Events (SAEs)|Incidence of study procedure-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat|||percentage of subjects|||Number
1425129|NCT01054560|Primary|Study Device-related Serious Adverse Events (SAEs)|Incidence of study device-related Serious Adverse Events (SAEs)|90 Day|Intent-to-treat|||percentage of subjects|||Number
1425130|NCT01054560|Secondary|Non-fatal Stroke-related Morbidity|Morbidity data is presented in terms of subjects with permanent deficit as a result of one or more adverse events|90 Day|Intent-to-treat|||percentage of subjects|||Number
1425131|NCT01054560|Secondary|Symptomatic Intracranial Hemorrhage|Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.|24 hours|Intent to treat|||Percentage of subjects|||Number
1425132|NCT01054560|Secondary|Mortality|Rate of Mortality|90 Days follow-up|Intent-to-treat|||Percentage of subjects|||Number
1425133|NCT01054560|Secondary|Good Neurological Outcome 90 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|90 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Percent of subjects|||Number
1425134|NCT01054560|Secondary|Good Neurological Outcome at 30 Days|Good neurological outcome, defined as modified Rankin scale (mRS) ≤ 2, or equal to the prestroke mRS if the prestroke mRS was higher than 2, or National Institutes of Health Stroke Scale (NIHSS) score improvement of 10 points or more|30 Days Follow-up|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Percent of subjects|||Number
1425135|NCT01054560|Secondary|Time to Initial Recanalization|Time from guide catheter placement to first visualization of Thrombolysis in Myocardial Infarction (TIMI) 2 flow|post treatment|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size|||minutes||Standard Deviation|Mean
1425136|NCT01054560|Primary|Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage|"Successful arterial recanalization of occluded target vessel measured by Thrombolysis in Myocardial Infarction (TIMI) score of 2 or 3 following the use of the SOLITAIRE™ or MERCI® Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes.~Thrombolysis in Myocardial Infarction (TIMI) score describes the distal flow perfusion and revascularization before and following therapy.~TIMI 0 - No perfusion (worst outcome) TIMI 1 - Perfusion past the initial occlusion, but no distal branch filling TIMI 2 - Perfusion with incomplete or slow distal branch filling TIMI 3 - Full perfusion with filling of all distal branches (best outcome)"|Immediately post treatment|Data was unavailable for two subjects from the randomized Solitaire and one from the randomized Merci cohort. Thus, the Core Lab evaluated data from 56 in the Solitaire FR group and 54 in the Merci group.|||Percent of Subjects|||Number
1425137|NCT01054404|Primary|Acceptable vs. Unacceptable Brain Relaxation at Dural Opening|"Rating of brain relaxation will be on a 4-point scale:~0 = brain very relaxed under dura, acceptable~= brain adequately relaxed under dura, acceptable~= brain slightly tense under dura, acceptable~= brain very tense under bulging dura, unacceptable"|just prior to dural opening for each subject||||units on a scale 0-3||Standard Error|Mean
1425138|NCT01054339|Secondary|Changes in Serum Total Alpha-1 Antitrypsin Concentrations|The change in serum total alpha-1 antitrypsin concentration was calculated as the difference between the mean values at the screening and baseline visits and the mean values at the 6, 9 and 12 month visits. The standard error of the difference was calculated as sqrt(s1^2/n1 + s2^2/n2, where s1 is the standard deviation of the baseline mean, s2 is the standard deviation of the month 6-12 mean, n1 is the number of baseline values and n2 is the number of month 6-12 values.|During months 6-12 after study agent adminstration|Analysis bsed on all subjects enrolled in study.|||micromolar||Standard Error|Mean
1425139|NCT01054339|Secondary|Changes in Serum M-specific Alpha-1 Antitrypsin Concentration|The change in serum M-specific alpha-1 antitrypsin concentration was calculated as the difference between the mean values at the screening and baseline visits and the mean values at the 6, 9 and 12 month visits. The standard error of the difference was calculated as sqrt(s1^2/n1 + s2^2/n2, where s1 is the standard deviation of the baseline mean, s2 is the standard deviation of the month 6-12 mean, n1 is the number of baseline values and n2 is the number of month 6-12 values.|During months 6-12 after study agent adminsitration|One subject in low dose group had AAT phenotype SZ, which made measurement of M-specific serum alpha-1 antitrypsin concentration invalid.|||nanomolar||Standard Error|Mean
1425140|NCT01054339|Primary|Frequency of Grade 3 or 4 Adverse Events||During 1 year after study agent administration|Analysis based on all subjects enrolled in study.|||participants|||Number
1425141|NCT01054222|Secondary|King’s Health Questionnaire (KHQ) Domain Scores|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.|Baseline, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1425142|NCT01054222|Secondary|Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b)|OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication’s ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as ‘very satisfied’, ‘somewhat satisfied’, ‘neither dissatisfied nor satisfied’, ‘somewhat dissatisfied’, and ‘very dissatisfied’. The results for Q9 to 11 are reported as “satisfied” (participants who answered ‘very satisfied’ or ‘somewhat satisfied’ for all 7 questions) or “not satisfied” (participants who answered ‘neither dissatisfied nor satisfied’ or ‘somewhat dissatisfied’ or ‘very dissatisfied’ for all 7 questions).|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||participants|||Number
1425151|NCT01054222|Secondary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
1425143|NCT01054222|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1425144|NCT01054222|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1425145|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||Participants|||Number
1425146|NCT01054222|Secondary|Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||Participants|||Number
1425147|NCT01054222|Secondary|Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours|The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.|||Units per 24 hours||Standard Deviation|Mean
1425148|NCT01054222|Secondary|Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|FAS: all enrolled participants who had taken at least one dose of study treatment during study and completed at least one micturition diary. N (number of participants analyzed) signifies participants who had baseline UUI episodes >0 per 24 hours. 'n' signifies participants evaluable for this measure at specified time points. LOCF was used.|||Percentage of Participants|||Number
1425149|NCT01054222|Secondary|Percentage of Incontinent Participants at Baseline|UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary.|||Percentage of Participants|||Number
1425150|NCT01054222|Secondary|Daily Sum Rating on the Urinary Sensation Scale (USS)|The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Numerical decrease indicates improvement.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||Units on a Scale||Standard Deviation|Mean
1425152|NCT01054222|Secondary|Mean Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||micturitions per 24 hours||Standard Deviation|Mean
1425153|NCT01054222|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||micturitions per 24 hours||Standard Deviation|Mean
1425154|NCT01054222|Secondary|Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours|The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 4 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
1425155|NCT01054222|Secondary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Month 3, 6, 9, 12, 15, 18|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. 'n' signifies participants who were evaluable for this measure at specified time points. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
1425156|NCT01054222|Primary|Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|End of Treatment (up to Week 82)|Full analysis set (FAS): included all enrolled participants who had taken at least one dose of study treatment during the study and completed at least one micturition diary. Missing values were imputed using last observation carried forward (LOCF).|||episodes per 24 hours||Standard Deviation|Mean
1425157|NCT01054183|Primary|Overall Successful Intubation Rate: GlideScope Video Laryngoscopy (GVL) vs. Direct Laryngoscopy (DL).|Overall successful intubation rate defined as all successful intubations (by type) divided by all attempts (by type).|30 days; no long-term outcome measures were included|The study was powered for 62 patients per study arm. Due to slow patient enrollment, the study was stopped prior to full enrollment with the aforementioned 22 total patients.|||Percent of successful intubations|Participants||Number
1425158|NCT01054183|Primary|Percent of Participants With Successful 1st Intubation Attempt|Percent of participants with successful 1st intubation attempt by group (GVL vs. DL)|30 days||||Percent of Participants|||Number
1425159|NCT01054170|Secondary|Exacerbations|Number of patients experiencing disease exacerbations on treatment.|Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Participants|||Number
1425160|NCT01054170|Secondary|Percentage of Reliever Free Days in Last Six Weeks of Treatment|Percentage of reliever free days in last 6 weeks on treatment.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||percentage of days||Standard Error|Least Squares Mean
1425161|NCT01054170|Secondary|St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
1425162|NCT01054170|Secondary|EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Total Score||Standard Error|Least Squares Mean
1425163|NCT01054170|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Total Score||Standard Error|Least Squares Mean
1425164|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425165|NCT01054170|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425166|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Evening (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1425167|NCT01054170|Secondary|Peak Expiratory Flow (PEF) Morning (Daily Recordings)|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.|Average from measurements recorded daily by patient in last 6 weeks of treatment.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1425168|NCT01054170|Secondary|Post-bronchodilator Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425169|NCT01054170|Secondary|Pre-bronchodilator Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425170|NCT01054170|Secondary|Post-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425171|NCT01054170|Secondary|Pre-bronchodilator Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425172|NCT01054170|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425173|NCT01054170|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425174|NCT01054170|Secondary|Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)|Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||mmol/kPa*min||Standard Error|Least Squares Mean
1425175|NCT01054170|Secondary|Pre-bronchodilator Specific Airway Conductance (SGaw)|Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||1/[s*kPa]||Standard Error|Least Squares Mean
1425176|NCT01054170|Secondary|Pre-bronchodilator Residual Volume (RV)|Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425177|NCT01054170|Secondary|Pre-bronchodilator Functional Residual Capacity (FRC)|Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425178|NCT01054170|Secondary|Pre-bronchodilator Total Lung Capacity (TLC)|Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425179|NCT01054170|Secondary|Pre-bronchodilator Inspiratory Capacity (IC)|Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1425180|NCT01054170|Secondary|Air Trapping Index (ATI) on Expiratory Scans|ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ATI Percentage||Standard Error|Least Squares Mean
1425181|NCT01054170|Secondary|5th Generation Wall Area Percentage|5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Percentage Area||Standard Error|Least Squares Mean
1425182|NCT01054170|Primary|AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)|AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.|Measured after 12 weeks treatment (day 84)|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||mm||Standard Error|Least Squares Mean
1425183|NCT01054079|Secondary|Change in Total and Free Testosterone|The detectable difference is estimated using a paired t-test approach. The lab measure will also be analyzed longitudinally using all measures with a mixed model approach adjusting for individual covariates.|Up to 20 weeks|No data collected||||||
1425184|NCT01054079|Secondary|Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)|The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score. All subscale items are summed to a total. The score range is 0-156. Higher scores represent better quality of life.|up to 20 weeks||||units on a scale||Standard Error|Mean
1429731|NCT01012167|Secondary|Laboratory Measures - HDL|High-density lipoprotein (HDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data from Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1425185|NCT01054079|Secondary|Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)|The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Epic produces two scores, one for function (5 items) and the other for bother (6 items). The response for each item is standardized to a 0 to 100 scale. For both scales, higher scores indicate worse outcomes.|up to 20 weeks||||units on a scale||Standard Error|Mean
1425186|NCT01054079|Secondary|Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory|The Brief Male Sexual Inventory is an 11 question assessment including subscales: sex drive, erections, ejaculation. The scores are totaled to produce an overall score with a range of 1-45, with higher score indicating worse outcomes.|Up to 20 weeks||||units on a scale||Standard Error|Mean
1425187|NCT01054079|Primary|Rate of Rise of Serum PSA|The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant’s post PSA level.|24 weeks||||Nanograms Per Milliliter||Inter-Quartile Range|Median
1425188|NCT01053988|Secondary|Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
1425189|NCT01053988|Secondary|Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, and centre grouping.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication. Only those participants available at the indicated time point and without missing covariate information were analyzed.|||Liters||Standard Error|Least Squares Mean
1425190|NCT01053988|Secondary|Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168|Considered an ‘Other’ endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Scores on a scale||Standard Error|Least Squares Mean
1425191|NCT01053988|Primary|Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
1425204|NCT01053663|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
1425205|NCT01053663|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429732|NCT01012167|Secondary|Laboratory Measures - Cholesterol|Total cholesterol blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1425192|NCT01053988|Primary|Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168|Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.|Baseline (BL) to Day 168|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liters||Standard Error|Least Squares Mean
1425193|NCT01053897|Secondary|Manchester Scar Scale (MSS)|"Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales.~MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions.~Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4).~Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4).~Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4).~Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)||||units on a scale||Standard Deviation|Mean
1425194|NCT01053897|Secondary|Patient Observer Scar Assessment Scale (POSAS)|"Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse).~Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months)"|12 Month (End of Study)|All subjects were included|||units on a scale||Standard Deviation|Mean
1425195|NCT01053897|Secondary|Overall Scar Preference|Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.|12 Month (End of Study)|All Subjects included.|||participants|||Number
1425196|NCT01053897|Primary|Photography- Independent Scar Assessment Panel|An independent panel was planned to review scar photography to determine more preferable outcomes. Panel was not performed.|0.5, 1, 2, 3, 6, 9 and 12 Months|All subjects had scar photography completed at study visits. However, due to the early termination of this trial, the independent panel review was not completed.||||||
1425197|NCT01053819|Secondary|A Secondary Objective Will be to Evaluate the Identified Pigmented Lesions for Suspicious Criteria|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.|Patients will complete the study within 6 months|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.||||||
1425198|NCT01053819|Primary|The Primary Endpoint for This Study Will be a Change From Baseline in the Number of Pigmented Lesions on Skin Previously Covered by Psoriatic Plaques.||Patients will complete study within 6 months.|The data for this Outcome was not collected and due to the length of time, the records have been destroyed.|||participants|||Number
1425199|NCT01053741|Primary|Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention.|"Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.~Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention."|One hour||||units on a scale||Inter-Quartile Range|Median
1425200|NCT01053663|Secondary|Number of Participants With Oseltamivir Resistance Mutation|Resistance was assessed by neuraminidase (NA) and hemagglutinin (HA) genes sequencing analysis, using Reverse Transcription Polymerase Chain Reaction (RT-PCR).|Up to Day 30|Safety population.|||participants|||Number
1425201|NCT01053663|Secondary|Number of Participants With Greater Than or Equal to (≥) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either ≥5 times change in the NAI IC50 visit value from the Reference value at a visit or ≥5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Days 1, 3, 4, 6, 15|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.|||participants|||Number
1425202|NCT01053663|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
1425203|NCT01053663|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1425207|NCT01053663|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1425208|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1425209|NCT01053663|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1425210|NCT01053663|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.|||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1425211|NCT01053507|Secondary|Migraine Specific Quality of Life Questionnaire (MSQ)||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
1425212|NCT01053507|Secondary|Headache Impact Test-6 (HIT-6) Score||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
1425213|NCT01053507|Secondary|Mental Efficiency Workload Test (MEWT) Performance Index||Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
1425214|NCT01053507|Primary|Associated Headache Symptoms|Change in number of associated headache symptoms at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
1425215|NCT01053507|Primary|Headache Days|Change in number of headache days at Day 0 vs. Day +30 in Treximet arm vs. Placebo arm.|Day 0, Day +30|No data displayed because outcome measure has zero total participants analyzed. No analysis was conducted. Study terminated due to low enrollment.||||||
1425216|NCT01053429|Other Pre-specified|Change From Baseline in Drug Attitude Inventory (DAI-10) - Improvement|DAI-10: a 10-item scale to assess how the attitude of participants with schizophrenia toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicates a positive subjective response (compliant); a negative score indicates non-compliance.|Baseline up to Week 8|Safety analysis set. It was recommended to use the optional DAI-10 tool to gather additional information for the improvement score under usual practice. The optional DAI-10 tool was not used during the study.|||participants|||Number
1425217|NCT01053429|Other Pre-specified|Change From Baseline in Brief Psychiatric Rating Scale (BPRS ) - Improvement|BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.|Baseline up to Week 8|Safety analysis set: all participants who received at least 1 dose of study treatment. It was recommended to use the optional BPRS tool to gather additional information for the improvement score under usual practice. The optional BPRS tool was not used during the study.|||particpants|||Number
1425218|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - PP|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|PP; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).|||participants|||Number
1425219|NCT01053429|Primary|Number of Participants for Change From Baseline in Clinical Global Impression - Improvement (CGI-I) at Final Visit (up to Week 8) - ITT|CGI-I is a single-item clinician rated scale used to assess the participant's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.|Baseline up to Week 8|ITT; N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-I at each visit but completed at last visit (no set schedule for study visits).|||participants|||Number
1425220|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Per Protocol Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Per Protocol population (PP): participants in ITT group with study treatment for at least 8 (± 1 week) since enrollment and observed for final efficacy (inpatient visit or phone call). N=participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).|||participants|||Number
1425221|NCT01053429|Primary|Number of Participants for Clinical Global Impression of Severity (CGI-S) Status at Final Visit (up to Week 8) - Intent to Treat Population|CGI-S is a single-item clinician rated scale to rate the severity of a participant's illness over time. Scores range from 1 (normal, not ill at all) to 7 (among the most extremely ill); higher score indicates more affected.|Baseline up to Week 8|Intent to treat population (ITT): administered at least 1 dose of study treatment at least once a week and observed for at least 1 efficacy assessment. N=number of participants with evaluable data at observation. Efficacy analysis planned for CGI-S at each visit but completed at last visit (no set schedule for study visits).|||particpants|||Number
1425222|NCT01053312|Secondary|Quantitative Estimates of Amyloid Levels ( Percent % Plaque Load) for the Following 7 Subjects|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.|Post-contrast Administration|Using the Precent area of Plaque values from the Primary Anaylsis, determine the association between cerebral cortical uptake of [18F] flutemetamol (as contralateral, ipsilateral, and composite SUVR values) and Immunohistochemical and histochemical-based estimates of amyloid.|||Percentage of Plaque|||Number
1425223|NCT01053312|Primary|Comparsion Between Brain Uptake of [18F] Flutemetamol Amyloid Level From Immunohistochemistry Assay and a Stained Biopsy Tissue Specimen.|This was an amyloid level estimate measured by Immunohistochemistry assay to determine the percentage of plaque area for mAb NAB228. The Immuno-histo chemical reagent was monoclonal antibody (mAB) NAB228. This is a percentage of the area of the biopsy tissue specimen that stains positive for amyloid using NAB228.|Post-contrast administration||||Percent plaque area|||Number
1425224|NCT01053312|Primary|Quantitative Estimates of Brain Uptake [18F]Flutemetamol and the Quantitative Immunohistochemical (IHC) Estimates of Amyloid Levels in Biopsy Samples Previously Obtained.|Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV_voi/SUV_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV_voi) or reference region (SUV_ref). VOI means volume of interest and REF means reference region.|Post-contrast administration||||Standard Uptake Value Ratio (SUVR)|||Number
1425225|NCT01053247|Secondary|The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region, the Mean Change From Baseline in Pruritus and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA).||2 weeks|||||||
1425226|NCT01053247|Primary|Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment||2 weeks||||participants|||Number
1425227|NCT01053156|Secondary|VAS Categorized by Behavior: Other|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with other behaviors that were not able to be categorized.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors not falling into the other categories were placed into this category. As not every caregiver named a behavior unrelated to the other categories, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
1425228|NCT01053156|Secondary|VAS Categorized by Behavior:Language/ Cognition|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with language or cognitive symptoms.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding language or cognition symptoms were placed into this category. As not every caregiver named a behavior related to language or cognition, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
1425229|NCT01053156|Secondary|VAS Categorized by Behavior:Anxiety/ Mood|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with anxiety or mood related behaviors.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding anxiety or mood symptoms were placed into this category. As not every caregiver named a behavior related to anxiety or mood, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
1425230|NCT01053156|Secondary|VAS Categorized by Behavior: Aggression/ ADHD|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with aggression or ADHD behaviors.|Baseline, 3 months, 6 months|In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding ADHD or Aggression symptoms were placed into this category. As not every caregiver named a behavior related to ADHD or aggression, this number is less than the number of participants.|||units on a scale||Standard Error|Least Squares Mean
1425231|NCT01053156|Secondary|Visual Analogue Scale Behavior 3- VAS3|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the third behavior that caregivers noted, out of three.|Baseline, 3 months, 6 months|This behavior was not provided by all of the participating caregivers, and so the number is less than the participants analyzed for other measures.|||units on a scale||Standard Error|Least Squares Mean
1425232|NCT01053156|Secondary|Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score|The ABC-C composite scores were used to quantify the severity of a patient’s behaviors. A composite score consists of subscale scores including Irritability and Agitation, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity and Noncompliance, and Inappropriate Speech. The composite score may range from 0-174. Lower scores indicate improvement.|Baseline, 3 months, and 6 months||||units on a scale||Standard Error|Least Squares Mean
1425293|NCT01052480|Secondary|Number of ICU Admissions|Number of ICU admissions during study follow-up. The intent was to analyze any number of ICU admissions.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||participants|||Number
1425233|NCT01053156|Secondary|Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score|The VABS-II Adaptive Behavior Composite Score was used to assess adaptive skills. An Adaptive Behavior Composite Score may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.|Baseline, 3 months, and 6 months||||units on a scale||Standard Error|Least Squares Mean
1425234|NCT01053156|Secondary|Expressive Vocabulary Test-2|The EVT-2 standard score assesses language development through a participant’s one word synonym response to visual stimuli. Standard scores range from 20-160. A standard score of 100 is average, with a 15 point standard deviation. Higher values represent a better outcome.|Baseline, 3 months and 6 months||||units on a scale||Standard Error|Least Squares Mean
1425235|NCT01053156|Secondary|Visual Analogue Scale- Behaviors 2|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the second behavior that the caregivers noted, out of three.|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Least Squares Mean
1425236|NCT01053156|Primary|Visual Analogue Scale- Behavior 1|A VAS is used to represent a caregiver’s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from “worst behavior” to “behavior not a problem.” Greater values indicate greater improvement. This measure represents the first behavior that the caregivers noted, out of three.|Baseline, 3 months, 6 months|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis|||units on a scale||Standard Error|Least Squares Mean
1425237|NCT01053156|Primary|Clinical Global Impression Scale (CGI)|The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 “very much improved” to 7 “very much worse”. Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner.|3 months (post first treatment) and 6 months (post second treatment)|Any participant who completed at least the first arm of the trial were included in the intention to treat analysis|||units on a scale||Standard Error|Least Squares Mean
1425238|NCT01053078|Secondary|Rates of Hypoglycemia||1 month|||||||
1425239|NCT01053078|Primary|Cerebral Blood Flow||1 month||||percentage of signal intensity change||Standard Deviation|Mean
1425240|NCT01053000|Primary|Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline.||12 weeks||||lesions||Standard Deviation|Mean
1425241|NCT01052948|Primary|Number of Participants With All-Cause Mortality Per 10,000 Participant-Years of Follow-Up|All participants who died independent of the cause to include instantaneous death, death occurring in less than 24 hours from onset of symptoms, not otherwise explained, unattended death and other causes of ill defined morbidity and mortality. Cause of death was coded and classified as either cardiovascular or respiratory.|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
1425242|NCT01052948|Primary|Number of Participants With Heart Failure Per 10,000 Participant-Years of Follow-Up|Occurrence of: unspecified acute edema of lung, heart failure, acute pulmonary heart disease, or acute cor pulmonale|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
1425243|NCT01052948|Primary|Number of Participants With Fibrosis Per 10,000 Participant-Years of Follow-Up|Occurrence of: idiopathic retroperitoneal fibrosis, occlusion not otherwise specified (NOS) of ureter, diffuse (idiopathic) (interstitial) pulmonary fibrosis, Hamman-Rich syndrome, interstitial pneumonia (desquamative) (lymphoid), fibrosis of lung (atrophic; confluent; massive; perialveolar; peribronchial) chronic or unspecified, pulmonary or pleural fibrosis, abnormal communication between pericardial and pleural sacs, pleural fold anomaly, adhesive or constrictive pericarditis, pericardial fibrosis|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
1425244|NCT01052948|Primary|Number of Participants With Fibrotic Valvular Heart Disease Per 10,000 Participant-Years of Follow-Up|Occurrence of: mitral stenosis with insufficiency, other unspecified mitral valve diseases, mitral or aortic valve stenosis, insufficiency, or disorders, multiple involvement of mitral and aortic valves, mitral and aortic valve diseases, unspecified, diseases of tricuspid valve, tricuspid valve disorders, specified as nonrheumatic, pulmonary valve disorders, endocarditis, valve unspecified, endomyocardial fibrosis, endocardial fibroelastosis, other primary or secondary cardiomyopathies, cardiomyopathy, functional and undiagnosed cardiac murmurs, other abnormal heart sounds.|Up to 12 years|Per protocol.|||Participants/10,000 Participant-Years|||Number
1425245|NCT01052844|Primary|Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1|Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy|6 days||||participants|||Number
1425246|NCT01052844|Primary|Number of Patients With Complete Response During Chemotherapy Course 1|The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)|5 days||||participants|||Number
1425247|NCT01052831|Secondary|Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)|The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease–Rating Scale (QUIP-RS) was developed for use in clinical trials and added as a secondary outcome measure for assessment of change in severity of ICD symptoms, to be completed at baseline and end of study only. For the QUIP-RS, scores for each compulsive behavior range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. Given that ICD symptoms are frequently comorbid in patients with PD, total QUIP-RS ICD scores (range from 0 to 64) were used to compare overall severity of ICD symptoms. Please note that this measure is reporting a change from baseline.|The QUIP-RS was administered at baseline and the termination visits (Visit 5, 8 weeks after baseline).|A linear mixed-effects model was used to estimate changes in QUIP-RS ICD scores from baseline to termination (visit 5, 8 weeks after baseline). Positive estimated change values represent a decrease in severity (frequency) of symptoms.|||Change in points on a scale (QUIP-RS)||95% Confidence Interval|Number
1429733|NCT01012167|Secondary|Laboratory Measures - CO2|Carbon Dioxide (CO2) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
1425248|NCT01052831|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on the Clinical Global Impression-Improvement (CGI-I) Scale|"The Clinical Global Impression-Improvement scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale. For the change in response status over time, a generalized estimating equation (GEE) model was used."|The CGI-I was administered at Visit 2 (week 2, two weeks after baseline) and Visit 5 (week 8, termination visit 8 weeks after baseline).||||percentage of responders|||Number
1425249|NCT01052779|Primary|Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5|The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).|Baseline (Day 1) and up to Week 5|ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).|||Participants|||Count of Participants
1425250|NCT01052779|Primary|Mean Change In Hemoglobin From Baseline (Day 1) To Week 5|"The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:~Hemoglobin Change = Hemoglobin (Week 5) – Hemoglobin (Baseline)~The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method."|Baseline (Day 1), Week 5|ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).|||g/dL||Standard Error|Least Squares Mean
1425251|NCT01052714|Primary|Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination|Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425252|NCT01052714|Primary|Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination|Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425253|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425254|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425255|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425256|NCT01052714|Primary|WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination|Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425257|NCT01052714|Primary|Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination|Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items.|Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425258|NCT01052714|Primary|Change in Mean Total Exercise Time Per Week From Baseline to Termination|Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Minutes per week||Standard Error|Mean
1425259|NCT01052714|Primary|Change in Mean Empty Calories Consumed Per Week From Baseline to Termination|Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Calories per week||Standard Error|Mean
1425260|NCT01052714|Primary|Change in Mean Total Calories Consumed Per Week From Baseline to Termination|Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Calories per week||Standard Error|Mean
1425261|NCT01052714|Primary|Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination|Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared.|Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Scores on a scale per week||Standard Error|Mean
1425262|NCT01052714|Primary|Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Mg/dL per week||Standard Error|Mean
1425263|NCT01052714|Primary|Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Mg/dL per week||Standard Error|Mean
1425264|NCT01052714|Primary|Mean Triglycerides Level Change Per Week From Baseline to Termination|Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Mg/dL per week||Standard Error|Mean
1425265|NCT01052714|Primary|Mean Serum Insulin Level Change Per Week From Baseline to Termination|Results obtained through VA facility’s Outpatient Lab. The study groups' average serum level changes per week were then compared.|Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Pmol/L per week||Standard Error|Mean
1425266|NCT01052714|Primary|Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination|Study personnel calculated each participant’s BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Units on a scale per week||Standard Error|Mean
1425267|NCT01052714|Primary|Mean Waist Circumference Change Per Week From Baseline to Termination|Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Inches per week||Standard Error|Mean
1425268|NCT01052714|Primary|Mean Weight Change Per Week From Baseline to Termination|Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.|Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.|Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join “Usual Care then Lifestyle Balance” group to receive the Lifestyle Balance intervention.|||Pounds per week||Standard Error|Mean
1425269|NCT01052701|Secondary|Plasma RBV Trough Concentrations|Plasma RBV trough concentrations.|Day 56||||micrograms per milliliter||Standard Deviation|Mean
1425270|NCT01052701|Primary|Ribavirin Triphosphate (RBV-TP) Intracellular Concentrations|Ribavirin Triphosphate (RBV-TP) intracellular concentrations.|Day 56||||picomoles per 10^6 cells||Standard Deviation|Mean
1425271|NCT01052662|Primary|Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8|Calculated survival curve from abstinence in Week 8 to first positive opioid urine screen or first reported relapse to opioid use to evaluate the effect of memantine on reducing early relapse and after rapid buprenorphine discontinuation on week 9. The last observation carried forward (LOCF) was used to perform our event survival analyses.|Weeks after buprenorphine discontinuation week 9|Participants that achieved complete abstinence by self-report that was confirmed with negative urine toxicology at week 8.|||participants|||Number
1425272|NCT01052662|Secondary|Treatment Retention|Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.|Weekly|Intent-treat-sample (ITT) that was inducted onto buprenorphine / naloxone and received one dose of study medication on week 2.|||weeks in treatment||95% Confidence Interval|Mean
1425273|NCT01052662|Primary|Change of Opioid Use From Week 1 to 13|The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.|Weekly from week 1 to 13|80 subjects intent-to-treat.|||Mean Proportion of Opioid Use in Week 13||Standard Error|Mean
1425274|NCT01052545|Primary|Number of Cases of CAUTI Inappropriately Under-treated (no Antibiotics Given)||Years 1, 2, & 3|The number of CAUTI undertreated in Arm 1=27, the number of CAUTI undertreated in Arm 2=17|||cases/1,000 bed-days||95% Confidence Interval|Number
1425275|NCT01052545|Secondary|Patient Level Analysis of Inappropriate Antibiotic Use|We looked at the percentage of cases of ASB (asymptomatic bacteriuria) that were inappropriately over-treated with antibiotics, and we also looked at the percentage of cases of CAUTI (catheter-associated UTI) that were not treated with antibiotics (under-treated).|three years|All patients on acute medical care wards or extended care wards during the three year study project who had a positive urine culture associated with the presence of a urinary catheter.|||percentage of cases|||Number
1425276|NCT01052545|Primary|Urine Cultures Ordered|Number of urine cultures collected per 1000 catheter-days for each unit|three years|For this outcome measure, the number of participants is the number of patients that had urine cultures ordered. One patient could have multiple cultures ordered. Arm 1=5209 urine cultures ordered. Arm 2=5979 urine cultures ordered. This number was standardized by bed-days. Arm 1=170345 bed-days. Arm 2=119409 bed-days.|||Total ucx ordered/1,000 bed-days||95% Confidence Interval|Number
1425277|NCT01052545|Secondary|Number of Catheter-days of Use Per 1000 Patient Bed Days on Each Unit||One year|||||||
1425278|NCT01052545|Secondary|Clinicians Acceptance of and Outcome Expectancy From Following the ABU Guidelines||one year|||||||
1425279|NCT01052545|Secondary|Clinicians' Awareness of and Familiarity With the ABU Guidelines.||one year|||||||
1425280|NCT01052545|Secondary|Number of Days Antibiotics Are Given to Treat ABU||one year|||||||
1425281|NCT01052545|Primary|Number of Cases of ABU That Are Treated Inappropriately With Antibiotics||Years 1, 2, & 3|The number of ASB treated in Arm 1= 180, the number of ASB treated in Arm 2= 65|||cases/1,000 bed-days||95% Confidence Interval|Number
1425282|NCT01052480|Secondary|Incidence of Spontaneous Abortion or Stillborn Fetus for Pregnant Women|Incidence of spontaneous abortion or stillborn fetus for pregnant female participants|Measured from Day 0 through Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1425283|NCT01052480|Secondary|Incidence and Duration of Pre-term Labor (Defined as Labor Occurring < 36 Weeks) for Pregnant Women|Incidence and duration of pre-term labor (defined as labor occurring < 36 weeks) for pregnant female participants|Measured through Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1425284|NCT01052480|Secondary|Incidence and Week of Gestation of Delivery of a Live Pre-term Infant for Pregnant Women|Incidence and week of gestation of delivery of a live pre-term infant for pregnant female participants|Measured through to Day 28|Measure was not analyzed since there was only one pregnant participant. No aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1425285|NCT01052480|Secondary|Duration of Viral Shedding < Lower Limit of Quantification (LLOQ) in Nasal Swabs|Duration of viral shedding < lower limit of quantification (LLOQ) in nasal swabs (restricted to participants with viral shedding >= LLOQ in nasal swabs at Day 0)|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with viral shedding >= LLOQ in nasal swabs at Day 0.|||days||Inter-Quartile Range|Median
1425286|NCT01052480|Secondary|Disposition Following Initial Hospitalization|"Disposition following initial hospitalization was categorized as follows: released home - home health care not required,  released home with home health care, transferred to long-term care facility, hospitalization ongoing at Day 28, deceased."|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||participants|||Number
1425287|NCT01052480|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation use in days. Multiple mechanical ventilation durations are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425288|NCT01052480|Secondary|Days on Mechanical Ventilation|Time (in days) of mechanical ventilation use|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425289|NCT01052480|Secondary|Incidence of Acute Respiratory Distress Syndrome (ARDS) Present|Incidence of participants with acute respiratory distress syndrome (ARDS), restricted to those without ARDS at Day 0.|Measured at Days 0, 1, 2, 4, 7, 14, 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This population is further restricted to those participants who did not have ARDS at Day 0.|||participants|||Number
1425290|NCT01052480|Secondary|Duration of Supplemental Oxygen|Duration of supplemental oxygen use in days|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425291|NCT01052480|Secondary|Days on Supplemental Oxygen|Time (in days) of supplemental oxygen use|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1439484|NCT00939107|Secondary|Quality of Life|Quality of life, general health, measured on the Short Form 36 questionnaire (worst:100, best:0)|twelve months posttreatment||2010-08-31|08/2010||||
1425294|NCT01052480|Secondary|Duration of Hospitalization|Days that a participant spent at the hospital. Multiple hospitalizations are summed up.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425295|NCT01052480|Secondary|28-day Mortality|Number of deaths during study follow-up|Measured from Day 0 through Day 28|All randomized participants|||participants|||Number
1425296|NCT01052480|Secondary|In-hospital Mortality|Number of deaths in hospital during initial hospital admission|Measured from Day 0 through Day 28|All randomized participants|||participants|||Number
1425297|NCT01052480|Secondary|50 Millimeters of Mercury (mm/Hg) Improvement in PaO2/FiO2 Ratio Over Time|Number of participants with ABG done and no increase of 50 millimeters of mercury (mm/Hg) or greater in PaO2/FiO2 ratio. PaO2/FiO2 ratio was evaluated by an ABG. ABG was performed only when clinically indicated.|Measured at Days 1, 2, 4, 7, 14, 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those participants with a PaO2/FiO2 ratio (ABG performed) at Day 0.|||participants|||Number
1425298|NCT01052480|Secondary|Time to 20% Improvement in Sequential Organ Failure Assessment (SOFA) Score for Participants >= 18 Years Old and Pediatric Logistic Organ Dysfunction (PELOD) Score for Participants < 18 Years Old|The analysis is restricted to participants >= 18 years old and the SOFA score because there were very few evaluations of the PELOD score during follow-up for the participants < 18 years old. The adult population was further subset to those with a non-missing and non-zero SOFA score at Day 0; those with missing SOFA score at Day 0 did not have a starting point, and those with SOFA = 0 at Day 0 could not have an improvement.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza. This subset was further restricted to those >= 18 years with an available (non-zero) Day 0 SOFA evaluation.|||days||Inter-Quartile Range|Median
1425299|NCT01052480|Secondary|Duration of Time to Resolution of All Symptoms and Fever|The assessed symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425300|NCT01052480|Secondary|Duration of Time to Resolution of Fever|Fever was defined as either a temperature > 38.0 C, or a report of a Grade 1 or higher fever as an adverse event.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425301|NCT01052480|Secondary|Duration of Time to Resolution of Clinical Symptoms|The assessed clinical symptoms were nausea, vomiting, diarrhea, sore throat, headache, muscle ache, cough, and shortness of breath. Symptoms were assessed at days 0, 1, 2, 4, 7, 14, and 28.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425302|NCT01052480|Secondary|Time to Normalization of Respiratory Status (All Randomized Participants)|Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.|Measured from Day 0 through Day 28|All randomized participants|||days||Inter-Quartile Range|Median
1425303|NCT01052480|Primary|Time to Normalization of Respiratory Status (Primary Efficacy Population)|Normalized respiratory status is defined as room air saturation of oxygen [SaO2] greater than or equal to 93% AND respiratory rate within normal ranges.|Measured from Day 0 through Day 28|The population analyzed is the Primary Efficacy Population (PEP), defined as the subset of randomized participants who tested positive for influenza.|||days||Inter-Quartile Range|Median
1425304|NCT01052428|Primary|Peak Early Filling Rate: Rate of Change Over Time|Peak Early Filling Rate The peak early filling rate of change is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||EDV/sec||Standard Deviation|Mean
1425305|NCT01052428|Primary|Systolic Longitudinal Strain|Systolic Longitudinal Strain. By identifying two points on the heart, the strain is the difference between the distance between these two points at the end of filling of the heart and the end of contraction divided by the length at the end of filling. Thus, the measure is like the ejection fraction, however the strain is more localized to a specified segment in the heart muscle. The higher values indicate a healthy heart.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent/%Systolic interval||Standard Deviation|Mean
1425306|NCT01052428|Primary|Left Ventricular Ejection Fraction|Left Ventricular Ejection Fraction Is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent||Standard Deviation|Mean
1425307|NCT01052428|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area|Left Ventricular End Systolic Volume Indexed to Body Surface Area As an indicator of heart size, the blood volume of the heart is related to the body size. The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
1425308|NCT01052428|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness|Left Ventricular End-Diastolic Radius to Wall Thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||unitless||Standard Deviation|Mean
1425309|NCT01052428|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||g/ml||Standard Deviation|Mean
1425310|NCT01052428|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area|Left Ventricular End Diastolic Volume Indexed to Body Surface Area: As an indicator of heart size, the blood volume of the heart is related to the body size. The end diastolic volume is the blood volume of the heart at the end of filling, just before contraction. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
1425311|NCT01052272|Primary|Peak Early Filling Rate Normalized to EDV|The Peak Early Filling Rate Normalized to EDV is calculated from the slope of the volume during the early filling of the heart with respect to time. The higher values indicate a very healthy heart muscle and lower values are indicative of a very stiff muscle. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||1/sec||Standard Deviation|Mean
1425312|NCT01052272|Primary|LV End Systolic Maximum Shortening (LVES Max Shortening)|By identifying three points in three different planes in the heart muscle, the maximum shortening is the average of the difference between the distance between these three points at the end of filling of the heart and the end of contraction divided by the length at the end of filling times 100. The maximum shortening is a three dimensional analysis. The higher values indicate a healthy heart. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent of length at end of filling||Standard Deviation|Mean
1425313|NCT01052272|Primary|Left Ventricular End Systolic Volume Indexed to Body Surface Area (LVESV/BSA)|LVESV/BSA: The end systolic volume is the blood volume of the heart at the end of contraction and is an index of the pump function of the heart. This relation to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
1425314|NCT01052272|Primary|Left Ventricular Ejection Fraction (LVEF)|LVEF is a calculation of heart pump function determined from the volume after complete filling minus the volume after complete contraction divided by the volume after complete filling. A value of 55% or greater is normal. This is a measure of LV Systolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||percent||Standard Deviation|Mean
1425315|NCT01052272|Primary|Left Ventricular End-diastolic Mass Indexed to Left Ventricular End-diastolic Volume (LVED Mass/LVEDV)|LVED Mass/LVEDV: As an indicator of heart muscle mass and heart blood volume, the mass indexed to end diastolic volume determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a three-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||g/ml||Standard Deviation|Mean
1425316|NCT01052272|Primary|Left Ventricular End-Diastolic Radius to Wall Thickness (LVED Radius/Wall Thickness)|LVED Radius/Wall thickness As an indicator of heart muscle mass and heart volume chamber diameter, the end-diastolic radius indexed to end diastolic wall thickness determines whether there is an adequate amount of heart muscle to pump the heart blood volume obtained from a two-dimensional analysis. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Geometry. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||unitless||Standard Deviation|Mean
1425317|NCT01052272|Primary|Left Ventricular End Diastolic Volume Indexed to Body Surface Area (LVEDV/BSA)|LVEDV/BSA: As an indicator of heart size, the blood volume of the heart is related to the body size. The relation of heart blood volume to body size is more accurate in determining pathology because larger people require a larger heart blood volume. The values that are too high or too low indicate a diseased myocardium. This is a measure of LV Diastolic Function. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals.|5 visits per Participant over 2 years (about every 6 months)|intent to treat|||ml/m^2||Standard Deviation|Mean
1425318|NCT01052207|Secondary|Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker.||2 years|||||||
1425319|NCT01052207|Secondary|Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline.||2 years|||||||
1425320|NCT01052207|Primary|Pediatric Logistic Organ Dysfunction Score in Critically Ill Children|"Pediatric Logistic Organ Dysfunction also known as the PELOD Score is a marker of severity of illness for Critically ill children. The PELOD includes six organ dysfunctions and 12 variables.~To calculate the PELOD score, each organ dysfunction received points for the single variable associated with the most points. The minimum number that can be assigned to an organ is 0 and the maximum number of points for an organ is 20, and the maximum possible PELOD score is 71. Organ dysfunction is identified if the score for any organ system was more than 0."|1 years|PELOD scores are not calculated for healthy controls. The score was developed to assess critically ill patients only.|||scores on a scale||Standard Deviation|Mean
1425321|NCT01052116|Primary|Mean Change From Baseline to 24 Weeks for FEV1||24 weeks||||Liters||95% Confidence Interval|Mean
1425322|NCT01052077|Secondary|Number of Participants With CGI-Improvement Response During Phase B Relative to the End of Phase A (Week 8).|CGI-I Response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||participants|||Number
1425323|NCT01052077|Secondary|Number of Participants With MADRS Remission During Phase B Relative to the End of Phase A (Week 8) Visit.|A MADRS remission was defined as MADRS Total Score =< 10 and >= 50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||participants|||Number
1425324|NCT01052077|Secondary|Number of Participants With MADRS Response During Phase B Relative to the End of Phase A (Week 8) Visit.|A MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8 visit). The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||participants|||Number
1425325|NCT01052077|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score by Study Week in Phase B Relative to End of Phase A.|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participants total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1425326|NCT01052077|Secondary|Change From End of Phase A (Week 8) to End of Phase B (Week 14) in the Hamilton Depression Rating Scale 17-item Version (HAM-D17) Total Score.|The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the “best” rating and the highest score (2 or 4) was the “worst” rating. The possible total scores were from 0 to 52.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1425327|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|The IDS-SR was a 30-item self-report measure, that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). For individual items, the scores range from 0 to 3. The IDS-SR are scored by summing responses to 28 of the 30 items to obtain a total score ranging from 0 to 84, higher values indicate greater disruption in the depressive symptoms.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1425328|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression- Severity Illness Scale (CGI-S) Score.|The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator had to answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1425344|NCT01051856|Secondary|Severity of the Pancreatic Fistula Leaks|Grading of the clinical severity of the leak was done according to the International Study Group on Pancreatic Fistula criteria. Severity of fistula was reported as clinically significant (Grades B and C) or not (Grade A). Grade C indicates the most severe clinical outcome.|90 days post operative||||Pancreatic fistula leaks|||Number
1425345|NCT01051856|Primary|Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation|Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.|90 days from the operation|Intention-to-treat analysis|||percentage of subjects|||Number
1425329|NCT01052077|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Trial Week Visit in Phase B.|The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1425330|NCT01052077|Secondary|Change From End of Phase A (Week 8) to Phase B in Sheehan Disability Scale (SDS) Score.|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. Scores of 5 and above are associated with significant functional impairment. The SDS total score ranges from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Baseline (end of week 8) to Week 14|The efficacy sample was the FAS comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1425331|NCT01052077|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|The MADRS was utilized as the primary efficacy assessment of a participants level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place.|Baseline (end of week 8) to Week 14|The efficacy sample was the Full Analysis Set (FAS) comprised of participants who received 1 dose of double-blind study medication and had both end of Week 8 visit value and 1 post-randomization efficacy assessment for MADRS total score in double-blind Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1425332|NCT01052038|Secondary|Hoarseness at 24 Hours|Self assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview.|24 hours||||participants|||Number
1425333|NCT01052038|Secondary|Opioid Consumption at 24 Hours|The cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine.|24 hours||||mg of oral morphine equivalents||Inter-Quartile Range|Median
1425334|NCT01052038|Secondary|Number of Subjects With Sore Throat at 3 Hours Post Surgery.|Subjects were asked at 3 hours post surgery if they were experiencing a sore throat.|3 hours.||||participants|||Number
1425335|NCT01052038|Secondary|Quality of Recovery at 24 Hours|The quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery|24 hours||||units on a scale (30 to 200) higher scod||Inter-Quartile Range|Median
1425336|NCT01052038|Primary|Subjects Assessment of Sore Throat Pain at 24 Hours|The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery.|24 hours||||units on a scale (1 to 5)||Inter-Quartile Range|Median
1425337|NCT01051986|Secondary|Early Angiographic Patency Rates|The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG|1.4days||||percentage of distal anastomoses|Participants||Number
1425338|NCT01051986|Secondary|Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)|freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years|4 years||||percentage of participants|||Number
1425339|NCT01051986|Secondary|Freedom From Cardiac Death|Freedom rate from cardiac death at 4 years|4 years||||percentage of participants|||Number
1425340|NCT01051986|Secondary|Overall Survival|Overall survival rate at 4 years|4 years||||percentage of participiciants|||Number
1425341|NCT01051986|Primary|1 Year Graft Patency Rates|1 year graft patency of second limb conduits measured by 1 year coronary angiography|one year||||percentage of distal anastomoses|Participants||Number
1425342|NCT01051921|Secondary|> 2 Log Decline in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at 24 Weeks|"Percent of patients experiencing a drop in HCV-RNA Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood equal to, or greater than, 2 log from before treatment (baseline) through 24 weeks of treatment."|Baseline and Study week 24|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.|||Percent of patients|||Number
1425343|NCT01051921|Primary|Early Virologic Response (EVR)|"Early Virologic Response (EVR) is defined as the percent of patients who experienced a drop in HCV-RNA (Hepatitis C Ribonucleic acid, also known as viral load) levels of more that 2 log from before treatment (baseline) through 12 Weeks of treatment."|Baseline and Study week 12|Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Therefore, efficacy analysis was not completed for this study.|||Percent of Patients|||Number
1425346|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T2 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|full analysis Set|||Cumulative new Gd-T2 lesions||Full Range|Mean
1425347|NCT01051817|Secondary|Raw Number of Cumulative New Gd-T1 Lesions|The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.|MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).|Full analysis set|||cumulative new Gd-T1 lesions||Full Range|Mean
1425348|NCT01051817|Primary|Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment|Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.|weeks 4,8,12,16,20,24,28|Full Analysis Set|||Combined Unique Active Lesions||Full Range|Mean
1425349|NCT01051791|Secondary|Objective Response Rate (ORR)|The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) / total evaluable patients.|Up to 60 months|Patients that completed at least 1 cycle of everolimus treatment. Response to treatment was evaluated by cross-sectional imaging every 8 weeks or as clinically indicated, starting at the end of cycle 2 and continuing until determination of progressive disease.|||percentage of participants|||Number
1425350|NCT01051791|Secondary|Overall Survival (OS)||Up to 60 months||||months||Full Range|Median
1425351|NCT01051791|Secondary|Progression Free Survival (PFS)||Up to 60 months||||months||Full Range|Median
1425352|NCT01051791|Primary|Clinical Benefit Rate (CBR)|The number of patients with recurrent/refractory SCCHN (head and neck squamous cell carcinoma) treated with single-agent everolimus that, experience a Complete Response (CR) + number of patients that experience a Partial Response (PR ) + number of patients that experience Stable Disease (SD) / total evaluable patients.|Up to 60 months|Patients that completed at least 1 cycle of everolimus treatment.|||percentage of participants|||Number
1425353|NCT01051778|Secondary|Spontaneous Osteoporotic Fractures||Duration of pregnancy and puerperium|||||||
1425354|NCT01051778|Secondary|Preterm Delivery||24 weeks gestation<Pregnancy <37weeks gestation|||||||
1425355|NCT01051778|Secondary|IUFD||Pregnancy >24 weeks gestation|||||||
1425356|NCT01051778|Secondary|Preeclampsia||Pregnancy > 20 weeks gestation|||||||
1425357|NCT01051778|Secondary|Thrombocytopenia||Duration of pregnancy and puerperium|||||||
1425358|NCT01051778|Secondary|Minor and Major Bleeding||Duration of pregnancy and puerperium|||||||
1425359|NCT01051778|Primary|Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)|Live birth occurs when a fetus (> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.|pregnancy > 24weeks gestation||||Percentage of pregnancies|||Number
1425360|NCT01051739|Primary|Number of Subjects Progressing in Each Group Using Pointwise Linear Regression|Perimetric method that most efficiently detects visual field change. secondary outcome: number of subjects progressing in each group using pointwise linear regression Linear regression was used to determine visual field worsening (progression) at each of 52 test locations. We required 3 or more worsening test locations at a p = 0.05 significance level for their to be significant progression.|4 years|Those that completed study|||participants|||Number
1425361|NCT01051570|Secondary|Overall Survival||After treatment, participants will be contacted every 3 months|||||||
1425362|NCT01051570|Secondary|Pharmacokinetics||Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2|||||||
1425363|NCT01051570|Secondary|Association of TTP and PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)||Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose|||||||
1425364|NCT01051570|Secondary|PSA Response Rate||Day 1 of each cycle (every 21 days)|||||||
1425365|NCT01051570|Secondary|Toxicity as Measured by NCI CTCAE v3.0 Criteria||Day 1 of each cycle (every 21 days)|||||||
1425366|NCT01051570|Primary|Time to Progression (TTP)|Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.||||months||90% Confidence Interval|Median
1425367|NCT01051557|Primary|Determine the Efficacy of Temsirolimus in Combination With Perifosine in Patients With Recurrent/Progressive Glioblastomas (GBMs) Not Taking EIAEDs as Measured by 6 Month Progression-free Survival (6mPFS) and Radiographic Response Rates. (Phase II)||5 years|Data were not collect as as study did not progress to Phase II.||||||
1425368|NCT01051557|Primary|Maximum Tolerated Dose of Temsirolimus|MTD defined as the dose at which fewer than one-third of patients experience a dose limiting toxicity (DLT) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)|28 days||||mg/week|||Number
1425369|NCT01051466|Secondary|Incidence of Suicidal Behavior and Suicidal Ideation as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captures the occurrence, severity, and frequency of treatment-emergent suicide-related thoughts and behaviors. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Treatment-emergent outcomes were the worsening or new occurrence of suicidal behaviors or ideation during treatment compared with baseline."|Baseline through Week 12|Participants with MDD who had a baseline and at least 1 post-baseline C-SSRS assessment. Healthy participants did not have a C-SSRS assessment post baseline.|||participants|||Number
1455521|NCT00811317|Secondary|Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target)||24 hours||||percentage of blood glucose measurements|||Number
1425370|NCT01051466|Secondary|Hamilton Anxiety Rating Scale (HAMA)|The 14-item HAMA is used to assess the severity of anxiety. The investigator talked to the participant about their symptoms over the previous week. Each item was scored using a 5-point scale (0 = not present to 4 = very severe). Total HAMA scores could have ranged from 0 (normal) to 56 (severe).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMA observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
1425371|NCT01051466|Secondary|Patient's Global Impressions of Improvement (PGI-I) Scale|The PGI-I scale measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores can range from 1 (very much better) to 7 (very much worse).|Baseline, up to Week 12|Enrolled MDD participants who had at least 1 post-baseline PGI-I observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome. PGI-I observations were not completed for healthy participants.|||units on a scale||Standard Deviation|Mean
1425372|NCT01051466|Secondary|Clinical Global Impressions of Severity Scale (CGI-S)|The CGI-S measures severity of illness at the time of assessment. Scores can range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline CGI-S observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
1425373|NCT01051466|Secondary|Sheehan Disability Scale (SDS)|The SDS is a participant-rated questionnaire used to assess the effect of the participant's symptoms on work/school (Item 1), social life/leisure activities (Item 2), and family/home management (Item 3). Each item was rated on a visual analog scale (VAS) from 0 (not at all) to 10 (very severely). The SDS Global Functional Impairment Score (SDS Global Score) was the sum of the 3 items and could have ranged from 0 (unimpaired) to 30 (highly impaired). Higher values indicated higher functional impairment in the participant's work/social/family life.|Baseline and up to Week 12|Enrolled participants who had baseline and at least 1 post-baseline SDS observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
1425374|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Remission|HAMD17 remission is defined as a HAMD17 total score of ≤7 at Week 12 (endpoint). The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with remission was calculated as the number of participants with a HAMD17 total score of ≤7 divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||percentage of participants|||Number
1425375|NCT01051466|Secondary|Percentage of Participants With 17-Item Hamilton Depression Rating Scale (HAMD17) Response|HAMD17 response is defined as a >50% reduction in HAMD17 total score from baseline. The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed). The percentage of participants with a HAMD17 response was calculated as the number of participants with a >50% reduction in HAMD17 total score from baseline divided by the number of participants who had a HAMD17 observation at Week 12 then multiplied by 100.|Baseline, up to Week 12|Enrolled MDD participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||percentage of participants|||Number
1425376|NCT01051466|Secondary|17-Item Hamilton Depression Rating Scale (HAMD17)|The HAMD17 is a standardized instrument consisting of 17 items used to measure the severity of major depressive disorder (MDD) and improvements in depression symptoms. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicated greater symptom severity. The total score was the sum of the scores from HAMD17 Items 1 through 17 and could have ranged from 0 (not at all depressed) to 52 (severely depressed).|Baseline and up to Week 12|Enrolled participants who had a baseline and at least 1 post-baseline HAMD17 observation. Last observation carried forward (LOCF) was utilized when calculating the Week 12 endpoint outcome.|||units on a scale||Standard Deviation|Mean
1425377|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Proinflammatory Cytokines [Tumor Necrosis Factor Alpha (TNFα), Interleukin 1 (IL-1), and Interleukin 6 (IL-6)]|Cytokines are naturally produced and regulate responses to inflammation. Proinflammatory cytokines like TNFα, IL-1, and IL-6 increase inflammation in the body. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline cytokine observation (TNFα, IL-1, or IL-6), excluding 3 healthy participants who did not meet entry criteria.|||picograms per milliliter (pg/mL)||Standard Error|Least Squares Mean
1425385|NCT01051440|Secondary|Change in Clinical Global Impressions Improvement (CGI-I) Score.|The CGI-I score indicates the clinician's overall assessment of improvement in function from one visit to the next. The single item is scored from 1 to 7 with anchor points ranging from very much improved (1) to very much worse (7). A decrease in score reflects an improvement in functional status.|week 1 and week 9|All participants who were randomized to lisdexamfetamine or placebo were included.|||units on a scale|||Number
1425760|NCT01048424|Secondary|Change in Sleep Quality|The Pittsburgh Sleep Quality Index. A global sleep quality score derived from the PSQI can be used to index overall quality of sleep over the prior one-week period. Global sleep quality scores are continuous (range 0-21), with high scores reflecting poor sleep quality.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
1425378|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF) Receptors|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Tropomyosin receptor kinase B (trkB) is a receptor for BDNF, and pan-neurotrophin receptor p75 (p75NTR) is a receptor for proBDNF. p75NTR was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline trkB observation, excluding 3 healthy participants who did not meet entry criteria. No participant was analyzed for the change from baseline in p75NTR receptors.|||picograms per milligram (pg/mg)||Standard Error|Least Squares Mean
1425379|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Brain-Derived Neurotrophic Factor (BDNF) and the Precursor of BDNF (proBDNF)|There is evidence that stress may decrease BDNF expression, while antidepressant treatment reverses or blocks these effects. BDNF is a protein that occurs naturally and supports the survival and growth of some nerve cells in the brain. proBDNF is a precursor of BDNF. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline BDNF or proBDNF observation, excluding 3 healthy participants who did not meet entry criteria.|||nanograms per milliliter (ng/mL)||Standard Error|Least Squares Mean
1425380|NCT01051466|Secondary|Gs Alpha (Gsα)-Activated Adenylyl Cyclase|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Adenylyl cyclase is activated by Gsα, and when Gsα is translocated from lipid rafts it more effectively activates adenylyl cyclase. Gsα-activated adenylyl cyclase was not analyzed due to technical laboratory issues.|Baseline and Weeks 1, 8, and 12|No participants were analyzed.||||||
1425381|NCT01051466|Secondary|Translocation of Gs Alpha (Gsα) From Lipid Rafts in the Cell Membranes of Red Blood Cells (RBCs), White Blood Cells (WBCs) and Platelets Compared With Baseline|Gsα is a membrane-associated protein that couples receptors for neurotransmitters like serotonin to allow them to send messages between nerve cells - a process that may be altered during depression and antidepressant treatment. Gsα localization in the cholesterol-rich (lipid rafts) and cholesterol-poor regions of cell membranes of RBCs and platelets was measured with quantitative Western blots and reported as the ratio of Gsα (absorbance units) in Triton X-100 (TX-100) over Triton X-114 (TX-114), 2 detergents that discriminate between lipid raft and non-raft membrane domains. Translocation of Gsα was measured as the change from baseline in Gsα localization. Translocation of Gsα from lipid rafts in the cell membranes of WBCs was not analyzed due to technical laboratory issues. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Weeks 1, 8, and 12|Enrolled participants who had a baseline and at least 1 post-baseline Gsα localization observation, excluding 3 healthy participants who did not meet entry criteria. No participants were analyzed for the translocation of Gsα from lipid rafts in the cell membranes of WBCs.|||Ratio||Standard Error|Least Squares Mean
1425382|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Volume of Subgenual Anterior Cingulate, Amygdalae, and Hippocampus|The volume of specific brain regions is obtained using a structural magnetic resonance imaging (sMRI) procedure in which high-resolution spoiled gradient recall images are acquired in coronal brain slices. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline observation for the volume of specific brain regions, excluding 3 healthy participants who did not meet entry criteria.|||cubic millimeters (mm^3)||Standard Error|Least Squares Mean
1425383|NCT01051466|Secondary|Change From Baseline to 12-Week Endpoint in Activation [Blood Oxygenation-Level-Dependent (BOLD) Response to Implicit Processing of Sad Faces] for Each of the 3 Brain Regions|Functional magnetic resonance imaging (fMRI) is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces in each brain region (anterior cingulate, left amygdala and right amygdala) was measured by the percentage of signal change in BOLD response. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation, excluding 3 healthy participants who did not meet entry criteria.|||percentage of signal change||Standard Error|Least Squares Mean
1425384|NCT01051466|Primary|Change From Baseline to 12-Week Endpoint in the Functional Magnetic Resonance Imaging (fMRI) Mean Blood Oxygenation-Level-Dependent (BOLD) Response in the Amygdalae|Functional MRI or fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of sad faces was measured by the percentage of signal change in BOLD response from before to after sad faces processing. The percentage of signal change was calculated by taking the difference between BOLD response after sad faces processing and BOLD response before sad faces processing and dividing by BOLD response before sad face processing, then multiplying by 100. BOLD signals were measured using arbitrary magnetic resonance units. Amygdala BOLD activation was calculated as an average between the left amygdala activation and right amygdala activation. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) adjusted for group, visit, group-by-visit, and baseline value.|Baseline, Week 12|Enrolled participants who had baseline and at least 1 post-baseline activation (BOLD response) observation.|||percentage of signal change||Standard Error|Least Squares Mean
1425761|NCT01048424|Secondary|Change in Perceived Stress|Cohen Perceived Stress Scale. Scores are scaled from 0 to 40, with higher scores indicated greater perceived stress.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
1425386|NCT01051440|Secondary|Change in Clinical Global Impressions Severity (CGI-S) Score.|"The CGI-S score reflects the clinician's overall impression of the patient's functional status. The scoring for the single item ranges from 1 with an anchor of normal, not at all ill to 7 with an anchor of among the most extremely ill patients. Thus, higher scores indicate greater severity of symptoms."|baseline and week 8|All participants who were randomized to lisdexamfetamine or placebo were included.|||units on a scale|||Number
1425387|NCT01051440|Primary|Change in Montgomery Asberg Depression Rating Scale (MADRS) Score Over Time.|The change in MADRS score from the baseline visit to the week 8 visit is reported. The MADRS is a clinician-rated scale that consists of 10 items rated on a from 0 to 6 (maximum score of 60), with higher scores indicating greater symptom severity. An increase in score indicates a worsening of symptoms whereas a decrease indicates an improvement in symptoms.|baseline and 8 weeks|All participants randomized to lisdexamfetamine or placebo were included.|||units on a scale|||Number
1425388|NCT01051323|Secondary|Average Methoxy Polyethylene Glycol-epoetin Beta Dose|Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint.|||mcg||Standard Deviation|Mean
1425389|NCT01051323|Primary|Number of Participants Satisfied With Treatment at Final Visit|Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS|||participants|||Number
1425390|NCT01051323|Primary|Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy|Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.|||participants|||Number
1425391|NCT01051323|Primary|Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion|At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS. N (number of participants analyzed) = participants evaluable for this measure.|||participants|||Number
1425392|NCT01051323|Primary|Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion|"At final visit, physicians were asked to answer (yes or no) the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants."|Month 12 or early discontinuation|FAS|||participants|||Number
1425393|NCT01051323|Primary|Number of Physicians Satisfied With Treatment at Final Visit|Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.|Month 12 or early discontinuation|FAS|||physicians|||Number
1425394|NCT01051323|Primary|C-reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint.|||mg/dL||Standard Deviation|Mean
1425395|NCT01051323|Primary|Transferrin Saturation Values|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint.|||percent transferrin saturation||Standard Deviation|Mean
1425396|NCT01051323|Primary|Transferrin Values|Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint.|||mg/dL||Standard Deviation|Mean
1425397|NCT01051323|Primary|Serum Iron Values|Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint.|||mcg/dL||Standard Deviation|Mean
1425398|NCT01051323|Primary|Serum Ferritin Values|Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.|Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint.|||ng/mL||Standard Deviation|Mean
1425399|NCT01051323|Primary|Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size|For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.|Month 0 to Month 12|FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.|||g/dL||Standard Deviation|Mean
1425400|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.|Month 6 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.|||percentage of participants|||Number
1425401|NCT01051323|Primary|Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size|The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10–12 g/dL, 11–12 g/dL, and 11–13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.|Month 0 to Month 12|FAS. n = participants evaluable for specified category for each arm group, respectively.|||percentage of participants|||Number
1425402|NCT01051323|Primary|Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range|Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.|Month 0 to Month 12|FAS|||percentage of participants|||Number
1425403|NCT01050998|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|ADA detection measured by using electrochemiluminescence assays.|Day 1 up to Day 169|The immunogenicity population included all participants who received at least 1 dose of CAM-3001 and for whom at least one serum sample for immunogenicity testing was available.|||participants|||Number
1425404|NCT01050998|Secondary|Accumulation Ratio for Mavrilimumab After Last Dose by Region|Accumulation ratio was calculated as ratio of AUCtau after last dose and AUCtau after first dose. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||ratio||Standard Deviation|Geometric Mean
1425405|NCT01050998|Secondary|Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||days||Standard Deviation|Mean
1425406|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||ng*day/mL||Standard Deviation|Geometric Mean
1425407|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||days||Full Range|Median
1425408|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||ng/mL||Standard Deviation|Geometric Mean
1425409|NCT01050998|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Geometric Mean
1425410|NCT01050998|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The PK population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||days||Full Range|Median
1425568|NCT01050062|Secondary|Systolic Blood Pressure (SBP)|SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||mmHg||Standard Deviation|Mean
1425411|NCT01050998|Secondary|Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region|Data for European and Japanese regions were reported.|Blood samples were collected at pre-dose on Days 1, 4, 8, 15, 29, 57, and 85 as well as during follow up on Days 88, 99, 113 and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here “N” signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1425412|NCT01050998|Secondary|Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose|Participants received MTX at stable and tolerated dose during baseline were categorized as “low dose (<12.5 mg per week [mg/wk])”, “medium dose (>=12.5 - <20 mg/wk)”, and “high dose (>=20 mg/wk)”. Participants received oral CST at stable dose during baseline were categorized as “low dose (<5 mg/day)”, and “high dose (>=5 mg/day)”. Change in MTX and CST dose from baseline between Day 1-85 and Day 86-169 were categorized as follows: ‘Increased’, ‘no change’ and ‘decreased’. Participants were counted once with dose increases counted first, followed by no change and then dose decreases.|Baseline, Day 1 to 85, Day 86 to 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified parameter for each arm, respectively."|||participants|||Number
1425413|NCT01050998|Secondary|Number of Participants Who Had Additional Medications|Additional medication included concomitant medication (medication used for purposes other than managing rheumatoid arthritis [RA]) and RA medication (for managing RA). Number of participants who used concomitant medication and RA medication was reported by anatomical therapeutic chemical (ATC) classification system.|Baseline up to Day 169|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||participants|||Number
1425414|NCT01050998|Secondary|Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units per milliliter||Standard Deviation|Mean
1425415|NCT01050998|Secondary|Serum Concentration of Rheumatoid Factor (RF)||Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units per milliliter||Standard Deviation|Mean
1425416|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||mm/hr||Standard Deviation|Mean
1425417|NCT01050998|Secondary|Serum Concentration of Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hr||Standard Deviation|Mean
1425418|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP) by Region|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||mg/L||Standard Deviation|Mean
1425419|NCT01050998|Secondary|Serum Concentration of C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/L||Standard Deviation|Mean
1425420|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score by Region|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1425421|NCT01050998|Secondary|Health Assessments Questionnaire (HAQ) Pain Score|Participants were asked to assess the severity of pain in the past week on a 100 VAS with 0 being no pain and 100 being severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1425762|NCT01048424|Secondary|Change in Depression Symptoms|Beck Depression Inventory. Range of 0-63 (0-9 normal; 10-16 mild; 17-29 moderate; 30-63 severe).|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
1425422|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1425423|NCT01050998|Secondary|Health Assessments Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1425424|NCT01050998|Secondary|Patient Pain Assessment Score by Region|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||mm||Standard Deviation|Mean
1425425|NCT01050998|Secondary|Patient Pain Assessment Score|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm||Standard Deviation|Mean
1425426|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score by Region|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly. Data for European and Japanese regions were reported."|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||mm||Standard Deviation|Mean
1425427|NCT01050998|Secondary|Patient Global Assessment of Disease Activity Score|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
1425428|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score by Region|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||cm||Standard Deviation|Mean
1425429|NCT01050998|Secondary|Physician Global Assessment of Disease Activity Score|Physician Global Assessment of Arthritis was measured on a 0 to 10 centimeter (cm) Visual Analogue Scale (VAS), where 0 cm = very good and 10 cm = very bad.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||cm||Standard Deviation|Mean
1425430|NCT01050998|Secondary|Swollen and Tender Joint Count by Region|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Data for the European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||joints||Standard Deviation|Mean
1425431|NCT01050998|Secondary|Swollen and Tender Joint Count|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||joints||Standard Deviation|Mean
1425432|NCT01050998|Secondary|Continuous ACR (ACRn) Score by Region|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Data for European and Japanese regions were reported.|Day 85|"ITT population. Six participants were excluded from the ITT population for data integrity issues. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Error|Mean
1425433|NCT01050998|Secondary|Continuous ACR (ACRn) Score|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Error|Mean
1425434|NCT01050998|Secondary|Number of Participants Who Achieved ACR Categorical Responses|"ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. ACR responses were categorized as No response, ACR20 but not ACR50, ACR50 but not ACR70, and ACR70."|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||participants|||Number
1425435|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region|ACR20, ACR50, and ACR70, were defined as >=20%, >=50%, or >=70% improvement, respectively, in: SJC and TJC and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. Data for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percentage of participants|||Number
1425436|NCT01050998|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85|ACR20, ACR50, and ACR70, were defined as greater than or equal to (>=) 20 percent (%),>=50%, or >=70% improvement, respectively, in: swollen joint count and tender joint count and >=20%, >=50%, or >=70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
1425437|NCT01050998|Secondary|Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Expected duration of response (DOR) was calculated as response rate (in percentage) multiplied by mean DOR (in days) by using Weibull Model. Duration of DAS28 (CRP) and DAS28 (ESR) remission were not analyzed because very few participants achieved remission in the overall study population.|Baseline up to Day 169|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified parameter for each arm, respectively."|||Percentage of days|||Number
1425438|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score. Time to response for DAS28 (CRP) and DAS28 (ESR) by region were reported. Time to remission for DAS28 (CRP) and DAS28 (ESR) by region were not analyzed because time to remission for the overall study population could not be achieved.|Baseline up to Day 169 (follow-up)|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||days||95% Confidence Interval|Median
1425569|NCT01050062|Primary|Incidence of Adverse Events (AEs)|The number of patient with any AEs, patients with drug-related AEs|Week 52|The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey|||Patients|||Number
1425439|NCT01050998|Secondary|Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Response was defined as 1.2 decrease from baseline in DAS28 (CRP) or DAS28 (ESR) score. Remission was defined as less than 2.6 DAS28 (CRP) or DAS28 (ESR) score.|Baseline up to Day 169 (follow-up)|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||days||95% Confidence Interval|Median
1425440|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percentage of participants|||Number
1425441|NCT01050998|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Remission was defined as less than 2.6 DAS28 (ESR) or DAS28 (CRP) score.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
1425442|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. DAS28 (CRP) and DAS28 (ESR) for the European and Japanese regions were reported.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||units on a scale||Standard Error|Mean
1425443|NCT01050998|Secondary|Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85|DAS28 calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst) and CRP (mg/L) for DAS28 (CRP) or ESR (mm/hour) for DAS28 (ESR). Total score range: 0-9.4, higher score = more disease activity. DAS28 <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
1425444|NCT01050998|Primary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, reticulocytes, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, mean corpuscular volume, mean corpuscular haemoglobin concentration); serum chemistry (creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, gamma glutamyl transferase, CRP, ESR, albumin, total cholesterol, triglycerides, rheumatoid factor and anti-cyclic citrullinated peptide antibodies); urinalysis (albumin, glucose, protein, blood, nitrite).|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
1425445|NCT01050998|Primary|Change From Baseline in Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||percent saturation||Standard Deviation|Mean
1425446|NCT01050998|Primary|Oxygen Saturation Level at Day 85 by Region|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. Oxygen saturation for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percent saturation||Standard Deviation|Mean
1425447|NCT01050998|Primary|Oxygen Saturation Level at Day 85|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||percent saturation||Standard Deviation|Mean
1425612|NCT01049373|Secondary|Number of Days With Incapability to Work||15 weeks treatment|||||||
1425448|NCT01050998|Primary|Categorized Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing. The modified BORG dyspnea scale was categorized as - no/slight (0 to 2), moderate (3 and 4), severe (5 and 6) and very severe breathlessness (7 and above).|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||participants|||Number
1425449|NCT01050998|Primary|Change From Baseline in Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
1425450|NCT01050998|Primary|Dyspnea Score at Day 85|Modified Borg dyspnea scale is a validated participant reported outcome assessing participant’s perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
1425451|NCT01050998|Primary|Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||percent diffusion capacity||Standard Deviation|Mean
1425452|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure for the specified region for each arm, respectively."|||percent diffusion capacity||Standard Deviation|Mean
1425453|NCT01050998|Primary|Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85|DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide.|Day 85|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||percent diffusion capacity||Standard Deviation|Mean
1425454|NCT01050998|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline and Day 85|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure at the specified time point for each arm, respectively."|||liters||Standard Deviation|Mean
1425455|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC at Day 85 for the European and Japanese regions were reported.|Day 85|"The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for the specified region for each arm, respectively."|||liters||Standard Deviation|Mean
1425456|NCT01050998|Primary|Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 85|The safety population included all participants who received any dose of investigational product. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liters||Standard Deviation|Mean
1425457|NCT01050998|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Results|12-lead ECG was recorded and corrected QT (QTc) interval was measured with the participant in a rested supine position for at least 10 minutes. Any ECG abnormality deemed clinically significant as per investigator’s discretion were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
1425458|NCT01050998|Primary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
1425459|NCT01050998|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169 (follow-up)|The safety population included all participants who received any dose of investigational product.|||participants|||Number
1425613|NCT01049373|Secondary|Amount of Analgesics Used||15 weeks treatment|||||||
1425460|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1. DAS28 (ESR) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
1425461|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (ESR) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (ESR) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (ESR) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (ESR) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (ESR) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
1425462|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to =< 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1. DAS28 (CRP) response by EULAR category at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
1425463|NCT01050998|Primary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
1425464|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85. DAS28 (ESR) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
1425465|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85|DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (ESR) score at Day 85.|Day 85|The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
1425466|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85. DAS28 (CRP) response at Day 85 for the European and Japanese regions were reported.|Day 85|"The ITT population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues. Here n signifies participants who were evaluable for the specified region for each arm, respectively."|||percentage of participants|||Number
1425467|NCT01050998|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Day 85|The intent-to-treat (ITT) population analysis set included all randomized participants regardless of whether participants received any investigational product. Six participants were excluded from the ITT population for data integrity issues.|||percentage of participants|||Number
1425468|NCT01050946|Secondary|Disease-free Survival:Death or Relapse Will be Considered Events for This Endpoint.||3 years||||participants|||Number
1425469|NCT01050946|Secondary|Transplant Related Mortality (TRM): TRM is Death Occurring in Patients in Continuous Complete Remission.||1 year|only pt who was enrolled died of TRM|||participants|||Number
1425470|NCT01050946|Secondary|Time to Acute GVHD: We Will Assess the Incidence and Severity of Grades II-IV and Grades III-IV Acute GVHD From Day of Transplant.||100 days|only one participant - no analysis done||||||
1425471|NCT01050946|Secondary|Time to Platelet Engraftment: To Assess the Incidence of Platelet Engraftment From Day of Transplant,||100 days|No further analysis reported as only one patient enrolled||||||
1425472|NCT01050946|Secondary|Time to Neutrophil Engraftment: To Assess the Incidence of Neutrophil Engraftment From Day of Transplant|time to neutrophil recovery after transplant|100 days|Patient engrafted neutrophils and platelets but no statistical analysis possible||||||
1425473|NCT01050946|Secondary|Time to Relapse: To Assess the Incidence of Acute Leukemia or Lymphoma Relapse From Day of Transplant|NOT analyzed since there was only patient and no relapse was observed till patient passed away|2 years|Patient did not live to 2 years, no relapse observed||||||
1425474|NCT01050946|Primary|The Primary Objective is to Estimate the Overall Survival, Separately in the Two Risk Strata.||3 years|Only one patient enrolled on study. Patient died prior to time frame of 3 years. It is not possible to assess this outcome measure.||||||
1425475|NCT01050816|Secondary|Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery|The Modified Hannover Score System contains information about patient’s status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)|||scores||Standard Deviation|Mean
1425476|NCT01050816|Secondary|Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery|"A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.~The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point."|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)|||mm||Standard Deviation|Mean
1425477|NCT01050816|Primary|Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery|"AOFAS scores(best score-100,worst score- 0 )~pain-none:40/Strong and Always present:O~Function~activities-without support activities:10/need restrain, clutch , walker or wheelchair:0~Maximum gait distance- more than 6:5/ less than 1:0~gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0~Gait abnormality-none:8/marked:0~saggital mobidity- normal or minimal restrain:6/strong restraint:0~hindfoot mobidity -normal minimal restrain:6/strong restrain:0~ankle and hindfoot stability - stable:8/unstable:0~alignment- good:10/bad:0"|baseline(preoperative stage),12months post-surgery|Among the 30 patients, 27 who received CHONDRON transplantation became subjects for Full Analysis Set(FAS) analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)|||scores||Standard Deviation|Mean
1425478|NCT01050790|Secondary|CTA Expression Before and After Azacitidine Therapy|Six patients tested have demonstrated CTA up-regulation in either unfractionated bone marrow (n = 4) or CD138+ cells (n = 2). CTA (CTAG1B)-specific T cell response has been observed in all three patients tested and persists following SCT.|3 months||||participants|||Number
1425479|NCT01050790|Secondary|Pre- and Post-ALI Immune Response to Cancer Testis Antigens (CTA)|Not able to obtain outcome data.|6 months|Not able to obtain outcome data. The lab doing this correlative analysis lost the personnel support to process the samples.||||||
1425480|NCT01050790|Secondary|Progression-free and Overall Survival|"Survival and event-free survival curves (any event of fatality, relapse, acute or chronic GVHD) with Kaplan-Meier curves. The incidence curve for relapse – accounting for the competing risk of fatality – is plotted with step-wise curves. The R statistical software (version 2.15) was used for all time-to-event analyses, with the survival package used for survival curves, and the cmprsk package used for all competing risk curves.~Results: The one-year survival rate is 93.3% (SE = 0.4%), and the two-year survival rate is 86.1% (SE = 0.9%)."|1 year to 2 years|The outcome measure data was collected up to one to two years post transplant.|||percentage of participants||95% Confidence Interval|Number
1425614|NCT01049373|Secondary|Correlation of Efficacy With the Constitutional Type of the Patient, Measured by the Hattinger Constitutional Manual (HKM) and the Hattinger Constitutional Questionnaire (HKF)||following 15 weeks treatment|||||||
1425481|NCT01050790|Secondary|Time to Progression Post Transplant|Time to progression post transplant: For patients not in Complete Response (CR), progressive disease requires one or more: >25% increase in the level of the serum monoclonal paraprotein(absolute increase of at least 0.5 g/dL); > 25% increase in 24-hour urinary light chain excretion(absolute increase of at least 200m/24 hours). Increase plasma cells in a bone marrow aspirate( absolute increase of at least 10%). Definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of new bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum Ca > 11.5 mg/dL or > 2.65 mmol/L) not attributable to any other cause. All relapse categories require two consecutive assessments made any time before classification as relapse or progressive disease.|28 months|Progression is collected anytime after transplant.|||months||Full Range|Median
1425482|NCT01050790|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Time frame includes after stem cell transplant engraftment. Toxicity post ALI infusion: 1 patient grade 1 hypertension 90 min post infusion. Toxicity post Rev maintenance: 1 patient not tolerated, 1 patient dose decreased due to counts.|6 months||||participants|||Number
1425483|NCT01050790|Secondary|Complete Response Rate at 6 Months|16 of 17 patients proceeded to transplant. 6 month CR rate post transplant was 8/16 (50%).|6 months|1 patient did not proceed to transplant.|||percentage of participants|||Number
1425484|NCT01050790|Primary|Feasibility to Mobilize and Infuse Autologous Lymphocytes (ALI) After Immunomodulatory Therapy and After Stem Cell Transplant Engraftment|Time frame is post 2nd and 3rd cycles of rev/aza and after stem cell transplant engraftment.|6 months|17 of 17 patients were able to mobilize lymphocytes. 16 of 17 patients had lymphocytes infused post transplant. 1 patient was not able to mobilize stem cells and so did not go to transplant.|||participants|||Number
1425485|NCT01050764|Secondary|Serious Infections|Serious infections are reported as the number of participants experienced serious infections.|1 year|Population of participants that received HSCT and T-reg plus T-con|||Participants|||Count of Participants
1425486|NCT01050764|Secondary|To Measure the Incidence and Severity of Acute and Chronic GvHD|Population of participants that received HSCT and T-reg plus T-con, and developed actue, chronic, or any graft vs host disease (GvHD)|1 year||||Participants|||Count of Participants
1425487|NCT01050764|Secondary|Median Overall Survival (OS)|Reported as the median overall survival (OS) in months from infusion of the hematopoietic stem cells (HSCT)|25 months|Population of participants that received HSCT and T-reg plus T-con|||months||Standard Deviation|Median
1425488|NCT01050764|Secondary|Overall Survival (OS), 1 Year|Assessed as subjects remaining alive 12 months after CD34+ cell infusion (ie, excludes death due to any cause)|1 year|Population of participants that received HSCT and T-reg plus T-con|||Participants|||Number
1425489|NCT01050764|Secondary|Acute Graft-versus-Host-Disease (aGvHD)|The primary outcome was incidence of grade 3 or 4 acute graft-vs-host-disease (aGvHD), reported as the number of participants developing grade 3 or 4 aGvHD.|1 year|Population of participants that received HSCT and T-reg plus T-con|||Participants|||Count of Participants
1425490|NCT01050764|Primary|Maximum-tolerated Dose (MTD) of Regulatory and Conventional T-cells|The maximum-tolerated dose (MTD) was to be determined based on the safety and feasibility observed for a pre-determined set of cellular dose level combinations of regulatory T-cells (T-reg) and conventional T-cells (T-con).|30 days after HSCT infusion|Includes all participants that received HSCT|||cells/kg|||Number
1425491|NCT01050673|Secondary|Number of Patient's With Serious Adverse Events and Relationship to Device||28 days||||Number of patients|||Number
1425492|NCT01050673|Secondary|Number of Patient's With Wound-related Readmissions||28 days and 6 week follow up||||Number of patients|||Number
1425493|NCT01050673|Secondary|Length of Hospital Stay (1st Excision to Discharge (Days))||28 days||||Days||Standard Deviation|Median
1425494|NCT01050673|Secondary|Percentage of Patients Achieving Stable Closure Within Study Period||28 days||||percentage of patients|||Number
1425495|NCT01050673|Secondary|Quantitative Bacteriology From Standardised Tissue Biopsies Pre- /Post- 1st Excision & Pre-closure||28 days|Pre and post-excision values added, (cfu/g) tissue.|||cfu/g||Standard Deviation|Median
1425496|NCT01050673|Secondary|Cost of Reference Wound-related Surgical Procedures to Achieve Closure||28 days||||Dollars ($)||Standard Deviation|Mean
1425497|NCT01050673|Secondary|Cost Per Operative Procedure||28 days||||Dollars $||Standard Deviation|Mean
1425498|NCT01050673|Secondary|Time of Actual Excision Procedure||28 days||||Time (Minutes)||Standard Deviation|Median
1425499|NCT01050673|Primary|Difference in Time to Closure Between Wounds Surgically Excised With VERSAJET™ Hydrosurgery System and Those Surgically Excised Using Conventional Operating Room Techniques.||28 days plus 6 week follow-up||||Time (minutes)||Standard Deviation|Median
1425500|NCT01050660|Secondary|Anthropometric Measurements(Head Circumference)|Change in head circumference measurement reported in cm/week|At age of 28 days and at discharge||||cm/week||Standard Deviation|Mean
1425501|NCT01050660|Secondary|Anthropometric Measurements(Length)|Change in body length measurement reported in cm/week|At age of 28 days and at discharge||||cm/week||Standard Deviation|Mean
1425502|NCT01050660|Secondary|Anthropometric Measurements(Body Weight)|Change in body weight measurement reported in g/week|At age of 28 days and at discharge||||g/week||Standard Deviation|Mean
1425503|NCT01050660|Secondary|Length of Stay|Defines time to discharge or death.|At discharge from Newborn ICU/death||||Days||Inter-Quartile Range|Mean
1425504|NCT01050660|Secondary|Late Onset Sepsis|Bloodstream infection, defined as a positive blood culture obtained after 72 hours of life.|At the discharge from Newborn ICU||||participants who developed LOS|||Number
1425505|NCT01050660|Secondary|Incidence of Retinopathy of Prematurity (ROP)||At discharge from Newborn ICU||||participants who developed ROP|||Number
1425506|NCT01050660|Secondary|Incidence of Necrotizing Enterocolitis (NEC)||At discharge from Newborn ICU||||participants who developed NEC|||Number
1425507|NCT01050660|Secondary|Incidence of Bronchopulmonary Dysplasia (BPD)||36 weeks PMA or discharge home,whichever comes first||||participants who developed BPD|||Number
1425508|NCT01050660|Secondary|Mortality Rate- Death Rate Before Discharge From the Hospital||Discharge from the Newborn ICU||||participants|||Number
1425615|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12) Ment||following 15 weeks treat|||||||
1425509|NCT01050660|Primary|The Presence of Cholestasis at Age of 28 Days or When Full Enteral Nutrition is Achieved, Whichever is Longer.||28 days of age or when full enteral nutrition is acheived, whichever is longer|"Incidence of PNALD at Yale and UCLA NICU prior to the start of the study was around 40%.~Our goal was to decrease incidence by 50%/ Alpha of 5%/ Power of 80% We calculated a sample size of 65 infants in each group"|||participants who developed Cholestasis|||Number
1425510|NCT01050647|Secondary|Length of Latency Assessed as Number of Days||From rupture of membranes until delivery, assessed up to 34 weeks of gestation||||days||95% Confidence Interval|Median
1425511|NCT01050647|Secondary|Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days||From birth to discharge form delivery hospital, assessed up to 2 months||||days||95% Confidence Interval|Mean
1425512|NCT01050647|Secondary|Number of Participants With Neonatal Necrotizing Enterocolitis||From delivery to neonatal discharge, assessed up to 2 months||||Participants|||Count of Participants
1425513|NCT01050647|Secondary|Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage||From delivery until neonatal hospital discharge, assessed up to 2 months||||Participants|||Count of Participants
1425514|NCT01050647|Secondary|Number of Participants With Neonatal Respiratory Distress Syndrome||From delivery until neonatal hospital discharge, assessed up to 2 months||||Participants|||Count of Participants
1425515|NCT01050647|Primary|Number of Participants With Achievement of 34 Weeks Gestation|Delayed delivery until 34 weeks gestation.|From enrollment until delivery, an average of 34 weeks||||Participants|||Count of Participants
1425516|NCT01050634|Primary|Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26|The 3 LASA items concerning vaginal symptoms (discharge, dryness, itching/irritation) were combined as the sum of these 3 items. Lower scores corresponded to better QoL, with negative changes from baseline corresponding to improvements in vaginal symptoms. Total overall score range=0-300, Best score=0, Worst score=300|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.|||Scores on a scale (mm)||Standard Deviation|Mean
1425517|NCT01050634|Primary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores|Items: 1.General health 1=poor to 5=excellent 2.Limited moderate activities & 3.Climbing of stairs 1=lot to 3=not at all 4.Accomplished less & 5.Limited in kind of work due to physical health, 6.Accomplished less & 7.Work done less carefully due to emotional problems 1=yes, 2=no 8.Pain interfered with work 1=extremely to 5=not at all 9.Felt calm & 10.Had lot of energy 1=none to 6=all time 11.Felt downhearted & 12.Physical health/emotional problems interfered with social activities 1=all time to 6=none of the time. Higher scores=better QoL, positive changes from baseline=improvement in QoL.|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) Scores.|||Scores on a scale||Standard Deviation|Mean
1425518|NCT01050634|Primary|Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26|Assessment of severity of 13 items (Being irritable, Sweats, Vaginal discharge, dryness, and itching/irritation, Sleep disturbance, Feeling dizzy, Headaches, Bone or joint pain, Troubled by weight gain, Loss of sexual interest, Difficulties in becoming aroused – all from none to severe, and Bothered by treatment related difficulties (not at all to severely). Individual items scored by measuring distance in mm between left scale anchor and patient’s mark, where no severity=0mm, maximum severity=100mm and negative changes from baseline=lessening of severity.Score range=0-100|Baseline, Month 12|FAS=Number of participants analyzed. Missing values were imputed by LOCF. Number of subjects analyzed for single LASA item (n)=Number of subjects with Baseline and Final Visit (LOCF) scores for the single item.|||mm||Standard Deviation|Mean
1425519|NCT01050634|Primary|Change From Baseline in Thickness of Endometrium|"Ultrasound measurement. New derived variable for normalization of endometrium thickness:~1 = Endometrium thickness <=5mm 0 = Endometrium thickness >5mm"|Baseline, Month 12|FAS. Missing values were imputed by LOCF. Number of participants analyzed=Number of subjects with Baseline and Final Visit (LOCF) values.|||mm||Standard Deviation|Mean
1425520|NCT01050634|Primary|Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores|10 single-item in LASA format(100mm scale): Physical wellbeing (good to lousy); Mood (happy to miserable); Tiredness, Hot flushes, Feeling sick, Use of arm restricted - all none to a lot; Appetite (good to none); Effort to cope with illness (no effort to great deal of effort); Supported by people (much to not at all); Rating life in current condition (perfect to worst health). Individual items scored by measuring distance in mm between left scale anchor and patient’s mark, where best QoL=0mm, worst QoL =100mm, and negative changes from baseline=improvement in QoL.Score range=0-100|Baseline, Month 12|Full Analysis Set (FAS)=Subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy measurement=Number of participants analyzed. Missing values were imputed by last observation carried forward (LOCF). Subjects analyzed for single item (n)=Subjects with Baseline and Final Visit (LOCF) scores for the item|||mm||Standard Deviation|Mean
1425521|NCT01050582|Secondary|Number of Participants With Retrospectively Reported Potentially Prolactin-Related Adverse Events|Previous potentially prolactin-related adverse events, including hyperprolactinemia, were reviewed and abstracted from participants' medical records. Potentially prolactin-related adverse events include breast symptoms, menstrual disorders, hyperprolactinemia, and prolactinoma.|Retrospectively during the time of exposure for up to 2 years prior to the study visit||||participants|||Number
1425522|NCT01050582|Secondary|Age (Years) at Current Tanner Stage|Tanner stage is an evaluation of pubertal development with values ranging from 1 (pre-pubertal) to 5 (adult). A standardized, validated tool containing standardized pictures and written descriptions of the stages of pubic hair development, breast development for girls, and genital development for boys was used by physicians to make their assessment.|One single study visit, approximately one week after informed consent has been obtained|Participants with a physician assessed Tanner stage value.|||years||Standard Deviation|Mean
1425616|NCT01049373|Secondary|Change in Short Form Health Survey 12 Items (SF-12)||following 2 weeks treatment|||||||
1425617|NCT01049373|Secondary|Change in Oswestry Score||following 15 weeks treatment|||||||
1425618|NCT01049373|Secondary|Change in Oswestry Score||following 2 weeks treatment|||||||
1425619|NCT01049373|Secondary|Change in State of Health (BF-S)||following 15 weeks treatment|||||||
1425523|NCT01050582|Primary|Height (cm) Z-score at Study Visit|Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.|One single study visit, approximately one week after informed consent has been obtained|All participants with a height assessment available at the study visit.|||z-score||Standard Deviation|Mean
1425524|NCT01050569|Secondary|Time to Lapse or Relapse to Tobacco Use||26 weeks||||weeks||95% Confidence Interval|Median
1425525|NCT01050569|Secondary|Exposure to Tobacco Toxicants||6 weeks||||pmol/mg creatinine||95% Confidence Interval|Geometric Mean
1425526|NCT01050569|Primary|End of Follow-up Abstinence Rates|CO- and cotinine-verified point prevalence abstinence|36 weeks||||participants|||Number
1425527|NCT01050569|Primary|End of Treatment Abstinence Rate|Cotinine and carbon monoxide (CO) verified point prevalence abstinence|12 week||||participants|||Number
1425528|NCT01050543|Primary|Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (height) of the 1st & 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated complete recovery.|From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)|Full Analysis Set, defined as all participants who received randomized treatment and had at least one efficacy measurement.|||minutes||95% Confidence Interval|Geometric Mean
1425529|NCT01050530|Secondary|Ascites Volume|Change in ascites volume from baseline as measured by CT at end of treatment|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF|||mL||Standard Deviation|Mean
1425530|NCT01050530|Primary|Body ｗeight|Change in body weight from baseline after 7-day repeated oral administration of OPC|Baseline, Day 7 or at the discontinued of treatment|Full Analysis Set; LOCF|||Kg||Standard Deviation|Mean
1425531|NCT01050257|Secondary|Percentage of Participants With Influenza Symptoms|Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.|Days 1, 11, 15, 30|Intent-to-Treat population included all treated participants.|||Percentage of participants|||Number
1425532|NCT01050257|Secondary|Number of Participants With Viral Resistance|Nasal and Throat swabs were collected on Days 1, 4, 6, 11, 15 and 30 and were sent to a central laboratory for testing. Viral resistance was determined by phenotypic and genotypic testing.|30 days|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Participants|||Number
1425533|NCT01050257|Secondary|Time to Resolution of Fever for Participants Who Had a Fever at Baseline|Fever was defined as a temperature of ≥ 37.8 C (degrees Celsius). Resolution of fever was a temperature ≤ 37.2 for at least 21.5 hours.|Baseline, Up to 30 Days|Participants from the Intent-to-Treat Infected population, all treated participants with confirmed influenza infection by culture or RT-PCR, who had a fever at Baseline.|||Hours||95% Confidence Interval|Median
1425534|NCT01050257|Secondary|Percentage of Participants Who Had a Fever During the Study|Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).|Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
1425535|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4|Nasal and throat swabs were collected at Baseline and Day 4 and were sent to a central laboratory for analysis. Influenza Viral titers (amount of virus present) were determined by RT-PCR for Flu A and Flu B and were reported in log 10 copies/milliliter (mL). A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-Treat Infected population with data available for analysis. Only participants with positive influenza results are included.|||log 10 copies/mL||Standard Deviation|Mean
1425536|NCT01050257|Secondary|Change From Baseline in Influenza Titer by Culture at Day 4|Nasal and throat swabs collected at Baseline and Day 4 were sent to a laboratory for analysis. Viral influenza titer (amount of virus present) was determined by culture. A log 10 median tissue culture infective dose (TCID50) > 0.5= Positive culture. A negative change from Baseline indicated improvement (less virus present).|Baseline, Day 4|Participants from the Intent-to-treat Influenza Infected population with data available for analysis. Only participants with positive influenza results are included.|||log10 TCID50||Standard Deviation|Mean
1425537|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
1425538|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture=log10 median tissue culture infective dose (TCID50) > 0.5.|Days 1, 4, 6, 11, 15, 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
1425539|NCT01050257|Secondary|Percentage of Participants With Viral Shedding by Culture or RT-PCR|Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).|Days 1, 4, 6, 11, 15 and 30|Intent-to-Treat Infected population included all treated participants who had confirmed influenza infection by culture or RT-PCR.|||Percentage of participants|||Number
1425540|NCT01050257|Secondary|Pharmacokinetics||Days 1, 3||2013-12-31|12/2013||||
1425620|NCT01049373|Secondary|Change in State of Health (BF-S)||following 2 weeks treatment|||||||
1425541|NCT01050257|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death|"Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~On treatment = AEs that started between the day of first dose and within 2 days after the last dose. Off treatment = AEs that started more than 2 days after the last dose of study drug."|Up to 30 days|Safety population included all participants who received treatment and had at least one post-treatment safety assessment. One patient in the 100 mg group actually received 200 mg and is included in the 200 mg group for safety.|||Partipants|||Number
1425542|NCT01050218|Primary|Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS).|The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.|Baseline and 9 months|The efficacy population was the intent-to-treat (ITT). This included all randomized subjects who had a baseline primary efficacy evaluation, had taken at least 1 dose of test article, and had at least 1 primary efficacy evaluation (ie, at least 1 NRS daily pain score) after the first dose of test article. No participants met that criterion.|||units on scale|||Number
1425543|NCT01050205|Secondary|Changes in Diastolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff’s sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mmHg||Standard Deviation|Mean
1425544|NCT01050205|Secondary|Changes in Self-reported Physical Activity Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|The Modifiable Activity Questionnaire (MAQ) was designed by Dr. Kriska. It has been used to assess activity in a variety of populations and age groups over various time frames and was used to assess physical activity levels in the DPP. The MAQ includes both a leisure and an occupational activity section since the homogeneity of energy expenditure related to both of these components of activity within many study populations cannot be assumed. In addition, the MAQ was designed to be modified, based upon pilot testing, prior to its usage, in order to maximize the feasibility and appropriateness of the physical activity instrument to the population of interest. The MAQ has been shown to be both reliable and valid (through comparisons with activity monitors, fitness (field) testing, and the doubly labeled water technique) in adults and adolescents alike. The MAQ has been used to assess a variety of time frames from past year and past week to a lifetime of activity.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.|||MET-hrs leisure activity||Inter-Quartile Range|Median
1425545|NCT01050205|Secondary|Changes in Waist Circumference Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|The participant was asked stand with feet together. The waist was measured using a cloth measuring tape around the abdomen. The midpoints were marked horizontally at midpoint between highest point of the iliac crest and lowest part of the costal margin in the mid-axillary line. Both sides of the waist were marked using a cosmetic pencil. The participant was asked to have arms at side and to breathe in, out and hold, and then the measurement was taken. Waist measurement was recorded to the nearest quarter inch. The measure was repeated twice. If waist measures differ by more than one-half inch, a third measurement was recorded.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.|||inches||Standard Deviation|Mean
1425546|NCT01050205|Secondary|Changes in Systolic Blood Pressure (BP) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Blood pressure was measured in the right arm with the participant seated comfortably with the right arm resting on a table. All participants were asked to rest quietly with feet flat on the floor for five minutes. Following the five minute wait, the radial pulse was measured in the right arm and pulse obliteration level was assessed. The cuff was inflated to the peak inflation rate and the pressure released at a rate of 2mm/Hg per second. First appearance and last heard (phase V) Korotkoff’s sounds were utilized to determine systolic and diastolic blood pressure respectively. The cuffed arm was then raised for 5 seconds after each inflation with a wait period of 30 seconds between each blood pressure reading. Blood pressure was repeated twice with the average computed. If it was not possible to measure blood pressure in the right arm, the left arm was utilized and noted in the participant record.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mmHg||Standard Deviation|Mean
1425621|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 15 weeks treatment|||||||
1425622|NCT01049373|Secondary|Change in Strength of Pain (Visual Analog Scale VAS)||following 2 weeks treatment|||||||
1425547|NCT01050205|Secondary|Changes in A1c Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers. A1c is a measure of glucose control over approximately an 8 to 12 week period.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1425548|NCT01050205|Secondary|Changes in Fasting Lipids (LDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
1425549|NCT01050205|Secondary|Changes in Fasting Lipids (HDL Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
1425550|NCT01050205|Secondary|Changes in Fasting Lipids (Triglycerides) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Inter-Quartile Range|Median
1425551|NCT01050205|Secondary|Changes in Fasting Lipids (Total Cholesterol) Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the work site and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
1425552|NCT01050205|Secondary|Changes in Fasting Insulin Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Venous blood draw: After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
1425763|NCT01048424|Secondary|Change in Anxiety Symptoms|Hospital Anxiety and Depression Scale. Anxiety Subscale range from 0 to 21, with scores of less than 8 indicative of absence of anxiety symptoms, 8 or above suggesting anxiety symptoms, and 12 or above suggesting generalized anxiety disorder.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
1425553|NCT01050205|Secondary|Changes in Fasting Glucose Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|After the participant signed the consent, they were taken to the private phlebotomy area. The participant sat in a stationary chair and placed their arm of choice for the blood draw flat on the table, on top of the BloodBloc pad. The participant was asked the last time they had anything to eat or drink, including candy, mint, gum, cough drops, cough syrup, coffee or tea, (participants were expected to fast for 8-12 hours prior to their assessment visit). If the participant had anything to eat or drink, other than water, the blood draw was rescheduled. The fasting blood sample was analyzed by Quest Diagnostics™ laboratory for the worksite and community/senior centers.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing. Individuals with medication changes related to the outcome were excluded from analysis.|||mg/dl||Standard Deviation|Mean
1425554|NCT01050205|Primary|Changes in Weight Between Baseline and Post-intervention (Assessed at 6 Months After Commencement of Intervention) Compared to Delayed Intervention Participants.|Weight was measured twice using a digital physician’s scale (DETECTO® PD100) placed on a hard, flat surface. Participants were asked to remove their shoes and stand in the middle of the scale with eyes straight forward and without touching any surface. The participant was asked to step down from the scale between measures. If the measures were more than 0.5 pounds apart, a third measure was taken. Weight is reported in pounds.|Baseline and post-intervention (assessed at 6 months after commencement of intervention)|Intent to treat using last observation carried forward when data are missing.|||Pounds||Standard Deviation|Mean
1425555|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Protein C|Study day five.||||percentage of activity||Standard Error|Mean
1425556|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti-thrombin III|Study day five.||||percentage of activity||Standard Error|Mean
1425557|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Fibrinogen|Study day five.||||mg/dL||Standard Error|Mean
1425558|NCT01050153|Secondary|Conventional Coagulation Testing Parameters|Plasma based conventional coagulation testing parameters - Anti Xa|Study day five.||||IU/mL||Standard Error|Mean
1425559|NCT01050153|Secondary|TEG Parameters|"Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc).~The absolute SEMS of the sample can be calculated from MA as follows:~G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA."|Study day five.||||Kd/sc||Standard Error|Mean
1425560|NCT01050153|Secondary|Platelet Count|Platelet count measured by CBC test|Study day five.||||* 10^3 platelets/µL||Standard Deviation|Mean
1425561|NCT01050153|Secondary|International Normalized Ratio (INR)|Plasma based conventional coagulation testing parameters|Study day five.||||ratio||Standard Error|Mean
1425562|NCT01050153|Secondary|TEG Parameters|"R is a reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing).~Rf is a difference in reaction time between Fragmin-active and Fragmin-neutralized samples.~Achievement of a certain clot strength K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm).~Angle or α measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation.~MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets."|Study day five.||||Minutes||Standard Error|Mean
1425563|NCT01050153|Primary|Incidence of VTE|The incidence and nature of hypercoagulability and the incidence of deep vein thrombosis and pulmonary embolism in each randomized group and in the subgroup receiving anti-platelet therapy in addition to Fragmin (descriptive analysis only)|Day 28 or discharge, whichever comes first.||||participants|||Number
1425564|NCT01050153|Primary|Hypercoagulability|To determine the incidence of, and to characterize, hypercoagulability in a sample of trauma patients admitted to the SICU at DHMC using TEG and conventional clinical coagulation testing (APTT, INR), antithrombin III levels and protein C activity. Hypercoagulability is defined as TEG parameter G (clot strength) >10.9.|Study day five.|The reason for having 21 participants in the Control group and 18 participants in the TEG-guided group is that 21 and 18 participants in the respective groups stayed five days or longer. Four participants (25-21) in the Control group and seven participants (25-18) in the TEG-guided group stayed less than five days.|||participants|||Number
1425565|NCT01050062|Secondary|Blood Pressure Normalised Rate|The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||percentage of participants|||Number
1425566|NCT01050062|Secondary|Target Blood Pressure Achievement Rate|The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.|Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||Percentage of patients|||Number
1425567|NCT01050062|Secondary|Diastolic Blood Pressure (DBP)|DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.|Week 0 and Week 52|The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.|||mmHg||Standard Deviation|Mean
1425570|NCT01049984|Secondary|Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater|"Site raters were asked: Considering your total clinical experience with the particular population, how ill is the patient at this time? Answers were based on a 0-7 scale, with 0=not assessed, 1= normal, not at all ill, and 7= among the most extremely ill of patients.~Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|Day 0 (baseline), Week 18|Modified intent to treat|||participants|||Number
1425571|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant|CGI is used by the participant to rate his/her total improvement during the study. Specifically, participants are asked to compare their condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).|18 weeks|Modified intent to treat|||participants|||Number
1425572|NCT01049984|Secondary|Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater|"CGI is used by the site rater to rate participants total improvement during the study whether or not, in the investigators' judgment, it is due entirely to drug treatment. Specifically, site raters are asked to compare the participants condition at the beginning of the study to his/her condition at Week 18, how much has he/she changed? Answers are 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7(very much worse).~Site raters can be the medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant."|18 weeks|Modified intent to treat|||participants|||Number
1425573|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Part III – Motor Function|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, the third of which is reported in this outcome. Part III is a clinician's evaluation of motor function. Part III contains 14 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-56. Negative change from baseline values indicate improvement.~All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits"|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale III, and therefore that subscale was set as missing.|||units on a scale||Standard Error|Least Squares Mean
1425574|NCT01049984|Secondary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Part II – Activities of Daily Living|The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. UPDRS contains four parts, the second of which is reported in this outcome. Part II is the participants' evaluation of the disease's impact on normal activities. Part II contains a total of 13 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-52. Negative change from baseline values indicate improvement.|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment for subscale II, and therefore that subscale was set as missing.|||units on a scale||Standard Error|Least Squares Mean
1425575|NCT01049984|Primary|Change From Baseline to Week 18 in the Unified Parkinson’s Disease Rating Scale (UPDRS) Total Score for Parts I, II and III|"The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson’s Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement.~All site raters (medical doctor [MD], doctor of osteopathy [DO], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits."|Day 0 (baseline), Week 18|Modified intent to treat population - all randomized participants who took at least 1 dose of study drug and had both a baseline and at least 1 post-baseline efficacy assessment. Several participants had missing UPDRS items at baseline and during treatment; therefore the total UPDRS for these participants was set as missing.|||units on a scale||Standard Error|Least Squares Mean
1425576|NCT01049945|Secondary|Overall Survival (Phase II)||Up to 2 years from study completion (6 years total)||2016-10-31|10/2016||||
1425577|NCT01049945|Secondary|Progression Free Survival (Phase II)||Up to 2 years from study completion (6 years total)||2016-10-31|10/2016||||
1425578|NCT01049945|Secondary|Time to Progression (Phase II)||Up to 2 years from study completion (6 years total)||2016-10-31|10/2016||||
1425579|NCT01049945|Secondary|Duration of Response (Phase II)||Up to 2 years from study completion (6 years total)||2016-10-31|10/2016||||
1425580|NCT01049945|Primary|Confirmed Response Rate (Dose Level 4) Reported as the Percentage of Patients Achieving a Confirmed Response (sCR, CR, VGPR, or PR).|"Complete response (CR)~- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~Stringent complete response (sCR) - A CR plus normal FLC ratio and no clonal cells in bone marrow~Near complete response (nCR) A CR, with the persistence of original monoclonal protein~Very good partial response (VGPR)~- Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 h~Partial response (PR)~≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h.~a ≥50% decrease in the difference between involved and uninvolved FLC levels~or a ≥50% reduction in plasma cells is required in place of M-protein, if ≥30% at baseline."|Up to 6 cycles of treatment|All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion.|||percentage of participants||95% Confidence Interval|Number
1425581|NCT01049945|Primary|Dose Limiting Toxicity of Bendamustine Hydrochloride and Lenalidomide in Combination With Dexamethasone (Phase I)|"The Maximum Tolerated Dose (MTD) is the dose level below that at which a dose limiting toxicity (DLT) is observed in ≥ 33% (i.e., ≥ 2 of 6) subjects in a cohort. A dose limiting toxicity is defined as one of the following adverse events in the Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 deemed at least possibly related to treatment:~Grade 2 neuropathy with pain~Any grade 3 Non-Hematologic toxicity~Any grade Non-Hematologic event requiring a dose reduction in cycle 1 or delaying the next cycle by >14 days.~Grade 4 neutropenia~Febrile neutropenia~Grade 4 thrombocytopenia~Grade 3 thrombocytopenia associated with bleeding~Any Hematologic event requiring a dose reduction in cycle 1 or a delay in the next cycle of treatment by >14 days.~We are reporting the results of this endpoint as the number of DLTs per dose level."|One cycle of treatment|All participants registered to the Phase I portion of this study were evaluable for this endpoint.|||Dose Limiting Toxic Events|||Number
1425582|NCT01049802|Secondary|NIH Stroke Scale|"A composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale~15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity~Items are graded on a 3 or 4 point ordinal scale; 0 equates no impairment~Scores range from 0 – 42. Higher scores indicate greater severity.~Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989):~Very Severe: >25~Severe: 15 – 24~Mild to Moderately Severe: 5 – 14~Mild: 1 – 5"|Screening, baseline, post treatment, 1 month, 6 months|1 data point missing from treatment arm at 6 month|||units on a scale||Standard Deviation|Mean
1425583|NCT01049802|Secondary|Chedoke Arm Assessment|A 7 point scale of motor recovery scored separately for arm. 7 is good motor recovery and 1 is no movement.|Screening, baseline, weekly, post treatment, 1 month, 6 months|1 data point is missing in treatment arm at 6 month post|||units on a scale||Standard Deviation|Mean
1425584|NCT01049802|Secondary|Stroke Impact Scale|"The SIS is a quality of life questionnaire designed for stroke survivors. It is a 59 item measure~8 domains assessed:~Strength (4 items)~Hand function (5 items)~ADL/IADL (10 items)~Mobility (9 items)~Communication (7 items)~Emotion (9 items)~Memory and thinking (7 items)~Participation/Role function (8 items)~Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item~Summative scores are generated for each domain, scores range from 0-100"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm a 6 months|||units on a scale||Standard Deviation|Mean
1425585|NCT01049802|Secondary|Action Research Arm Test|"The ARAT is a measure of upper limb dexterity and is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:~3: Performs test normally~2: Completes test, but takes abnormally long or has great difficulty~1: Performs test partially~0: Can perform no part of test Range is 0-57 with higher scores relating to better upper limb dexterity"|Baseline, post treatment, 1 month, 6 months|1 data point is missing from treatment arm at both 1 week and 6 month follow-up|||units on a scale||Standard Deviation|Mean
1425586|NCT01049802|Primary|Upper Extremity Fugl-Meyer Score|Upper extremity Fugl-Meyer Score measures of motor impairment in hemiplegic upper limb of patients with stroke. The scoring follows the natural progression of motor recovery as defined by Twitchell (Brain. 1951; 64:443-480). The score was developed by Axel Fugl-Meyer and it has been validated (Scand J Rehab Med. 1975; 7:13-31; Stroke. 2009; 40: 1386-1391). The scale ranges 0-66 with 66 representing normal motor function and 0 representing no movement. There are 33 movement items each scored 0 (cannot perform), 1 (peforms partially), 2 (performs flawlessly)|Baseline, post treatment, 1 month, 6 months|6 month outcome is the primary endpoint. 1 data point is missing from the treatment arm at 6 month follow up.|||units on a scale||Standard Deviation|Mean
1425587|NCT01049776|Secondary|To Describe the Clinical Toxicity Profile of Pazopanib in This Particular Patient Population||after the first 6 patients and quarterly|||||||
1425588|NCT01049776|Primary|Proportion of Non Small Cell Lung Cancer Participants With Disease Control (Complete Response+Partial Response+Stable Disease) Based on RECIST 1.0 Measured by CT or MRI|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesion, taking as reference the baseline sum of the longest diameter: Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum Longest Diameter since the treatment started|12 weeks||||Proportion of participants||95% Confidence Interval|Number
1425589|NCT01049581|Secondary|Subscale on Cerebral Palsy Quality of Life Questionnaire for Children|This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years. It contains social , functioning, participation , emotional ,access, pain and disability, and family health components. Participation is the main component in this study. This sub score ranges from 0 to 81 , higher scores represent better participation|3months||||units on a scale||Standard Error|Mean
1425590|NCT01049581|Secondary|Daily Living Subscale of Vineland Adaptive Behavior Scale|Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old. The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.|3 months||||units on a scale||Standard Deviation|Mean
1425591|NCT01049581|Primary|Unit on Gross Motor Function Measure Scale (GMFM)|The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy|3 months|complete the study and examination|||units on a scale||Standard Deviation|Mean
1425764|NCT01048424|Secondary|Change in Overactive Bladder Symptoms|The Overactive Bladder Questionnaire (OAB-Q). 0- to 100-point scale. Higher scores on the OAB-Q indicate greater bothersomeness and impact of overactive bladder symptoms.|Baseline to 6 weeks||||Score on a Scale||Standard Deviation|Mean
1425592|NCT01049503|Secondary|Caries Progression in Caries-inactive Children After 1 Year, According to the Type of Dentifrice Used|The lesions’ progression was evaluated by the data from the examinations at baseline and after 12 months. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an ANC lesion or cavity (untreated cavity or filled tooth).|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.|||progressed lesions/child||Standard Deviation|Mean
1425593|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the the Quantitative Light Induced Method (QLF) (Lesion Area (mm^2))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline – 12 months)were calculated by the software at the QLF threshold of 5%.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.|||lesions/child||Standard Deviation|Mean
1425594|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used Assessed by the Quantitative Light Induced Method (QLF)(Fluorescence Change (∆F in %))|The white spot lesions' progression was also determined by the QLF in a subsample of 75 caries-active children. The images were captured from the deciduous teeth which had at least one smooth surface with a clinically visible ANC. For every lesion, the fluorescence change (∆F in %) and the area of the lesion (mm^2)(baseline – 12 months)were calculated by the software at the QLF threshold of 5%. A negative ∆F value indicates caries regression.|baseline and 12 months|The sample size was calculated according to Tranaeus et al. (2001). All the children that remained in the study after 12 months were analysed.|||lesions/child||Standard Deviation|Mean
1425595|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into Participants' Toenails 6 Months After Initiation of the Dentifrices Use.|Samples of nails were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Buzalaf et al. (2009). From the trial participants in the fluoridated area, a convenience sample of 161 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.|||µgF/g||Standard Deviation|Mean
1425596|NCT01049503|Secondary|Caries Regression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions’ progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.|||regressed lesions/child||Standard Deviation|Mean
1425597|NCT01049503|Secondary|Caries Progression in Caries-active Children After 1 Year, According to the Type of Dentifrice Used|The lesions' progression or regression was evaluated by the data from the examinations at baseline and after 12 months. The net increment was calculated from the difference between lesions' progression and regression. The lesions were considered to have progressed when a sound surface or inactive noncavitated (INC) caries lesion was reevaluated after 12 months as an active noncavitated caries lesion (ANC) or cavity (untreated cavity or filled tooth). The lesions' regression was considered when an ANC lesion was reevaluated after 12 months as INC lesion or sound surface.|baseline and 12 months|The sample size was based on a previous trial (Lima et al., 2008). Accordingly, 24 children per dentifrice treatment resulted in a 85% power (α=0.05) for detecting difference of 0.23 and 0.65 in caries increment in the caries-inactive and caries-active groups, respectively. All the children that remained in the study after 12 months were analyzed.|||progressed lesions/child||Standard Deviation|Mean
1425598|NCT01049503|Primary|Evaluation of the Concentration of Fluoride Incorporated Into the Biofilm Done 6 Months After Initiation of Dentifrices Use.|Samples of plaque were analyzed for fluoride using an ion-specific electrode after diffusion with hexamethyldisiloxane-facilitated disiloxane (HMDS).|6 months|The sample size was calculated according to Pessan et al. (2008). From the trial participants in the fluoridated area, a convenience sample of 47 children was randomly selected. They were randomly divided (block allocation) into 3 groups, according to the type of liquid dentifrice they had been using for 6 months.|||mmol/kg||Standard Deviation|Mean
1425599|NCT01049412|Secondary|Glycemic Variability in Fasting Blood Glucose (FBG) at Week 8 Endpoint|Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day between Week 6 and Week 8. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
1425600|NCT01049412|Secondary|Rate of Hypoglycemia Per 30 Days Baseline Through Week 8|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]. Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.|Baseline through Week 8 of each treatment period|All randomized participants who took at least one dose of study drug.|||number of hypoglycemia episodes/30 days||Standard Deviation|Mean
1425601|NCT01049412|Secondary|Percentage of Participants With Hypoglycemia Baseline Through Week 8|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole per Liter (mmol/L) (≤70 milligram per deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005].|Baseline through Week 8 of each treatment period|All randomized participants who took at least one dose of study drug.|||percentage of participants|||Number
1425602|NCT01049412|Secondary|Percentage of Participants With Antibody Status Change From Baseline to Week 8, Week 16 and Week 20|Negative is defined as either 'negative' from lab or percent binding <1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative.|Week 8, Week 16 and Week 20|All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements.|||percentage of participants|||Number
1425603|NCT01049412|Secondary|Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 8 Endpoint|The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches.|Week 8 of each treatment period|Participants who took at least one dose of study drug and had measurements at Week 8.|||picomoles per liter (pMol/L)||Geometric Coefficient of Variation|Geometric Mean
1425604|NCT01049412|Secondary|Daily Basal Insulin Dose at Week 2 and Week 8 Endpoint|LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Week 2 and Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with at least one non-missing value of the response variable at any of the subsequent weeks.|||nanomoles per kilogram (nmoles/kg)||Standard Deviation|Least Squares Mean
1425605|NCT01049412|Secondary|8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint|8-point SMBG profiles are measured at morning fasting BG (FBG), midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); treatment sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
1425606|NCT01049412|Secondary|Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I)|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Week 8 (Period I)|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
1425607|NCT01049412|Secondary|Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 8 (Period I)|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value, last observation carried forward (LOCF).|||percentage of participants|||Number
1425608|NCT01049412|Secondary|Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline to 8-week at Period I is from MMRM approach, which includes fixed effects of treatment (LY2605541, Glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; interaction between visit and treatment; and a random effect for participant.|Baseline, Week 8 (Period I)|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
1425609|NCT01049412|Secondary|Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles|It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. LS mean of daily Avg. BG is from MMRM, which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; a random effect for participant.|Baseline, Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
1425610|NCT01049412|Primary|Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles|It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday & evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin [HbA1c] group); visit; visit and treatment interaction; a random effect for participant.|Week 8 of each treatment period|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||millimole per Liter (mmol/L)||Standard Error|Least Squares Mean
1425611|NCT01049373|Secondary|Number of ADRs|frequency of ADR with a probable or possible causal relationship|within 15 weeks treatment||||adverse reactions|||Number
1425623|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.~Difference between screening and 15 weeks in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 15 weeks treatment|Only patients with assessable values at present time point were analyzed.|||units on a scale||Standard Deviation|Mean
1425624|NCT01049373|Secondary|"Change in Pain Score (SES), Subscale Sensoric Pain"|"Pain Perception Scale (SES) The SES is a patient questionnaire, which consists of 24 questions, both the affective (14 questions) and sensoric (10 questions) depict aspects.~Difference between V1 minus V-1 in the subscale sensoric pain Scale ranges from 10(=best) to 40(=worst)"|following 2 weeks treatment|Only patients with assessable values at present time point were analyzed.|||units on a scale||Standard Deviation|Mean
1425625|NCT01049373|Secondary|Change in FFbH-R Between Screening and 2 Weeks|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.~Change in FFbH-R between screening and 2 weeks Scale ranges from 0 (=worst) to 100(=best)"|between screening and 2 weeks treatment|ITT|||units on a scale||Standard Deviation|Mean
1425626|NCT01049373|Primary|Change in FFbH-R Between Screening and Week 15|"Hannover Functional Questionnaire (FFbH-R) As used in this study test FFbH-R is a special version of the FFbH for close to everyday diagnostics of functional impairment by back pain. It is a patient questionnaire, which consists of 12 questions for the acquisition of functional limitations consists in activities of daily living.~Change in FFbH-R between screening and week 15 Scale ranges from 0 (=worst) to 100(=best)"|between screening and 15 weeks treatment|ITT|||units on a scale||Standard Deviation|Mean
1425627|NCT01049360|Secondary|Change From Baseline in Morning Peak Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1|||Liters||Standard Error|Least Squares Mean
1425628|NCT01049360|Secondary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1|||Liters||Standard Error|Least Squares Mean
1425629|NCT01049360|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12)||0 to 12 hours post-dose on Day 14|ITT Population defined as randomized patients who took at least one dose of double-blind investigational product and who had at least 1 baseline and 1 post-baseline assessment of FEV1|||Liters||Standard Error|Least Squares Mean
1425630|NCT01049334|Secondary|Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement Duration of Relief Using Participant-Defined Definite Improvement Levels (DIL)|"As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial.~The time of first achieving DIL for 30 minutes within 6 hours (or until rescue or re-dosing) post-dosing will be determined. And the time falling below DIL within 6 hours will be determined. Duration is then defined as the time from first DIL until falling below DIL. Duration was set to zero if the STPIS score does not reach the DIL for at least 30 minutes for STPIS during the 6 hours."|6 hours|Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.|||minutes||Standard Deviation|Mean
1425631|NCT01049334|Secondary|Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement|"As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial.~An alternative definition of STPIS time to onset of relief was the time from initial dose to the time the participant reaching DIL for at least 30 minutes. Data were censored if DIL was not achieved by 120 minutes following initial dose. Definite improvement must also occur prior to re-dosing or using rescue medication."|2 hours|Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.|||minutes||95% Confidence Interval|Median
1425632|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05|"Data reported in summary form in Primary Outcome #1 are reported here at each post-dose timepoint until the comparison resulted in a P-value <=0.05 between the two treatment arms.~STPIS was used to measure sore throat pain intensity using a 100-mm visual analog scale completed by participants that measures “pain on swallowing” (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. The full range of the scale varies by timepoint due to the time weighting sum of SPID. The full scale at 40 minutes post dose was -3188 (complete pain relief within 2 minutes of dosing that lasts 40 minutes) to 812 (maximum pain within 2 minutes lasting 40 minutes) using the mean baseline STPIS.~If a participant used rescue medication (acetaminophen 650mg was allowed as needed), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (rec"|baseline (pre-dose), up to 23 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-23)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
1425633|NCT01049334|Secondary|Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose|"Participants used a 6-category relief scale (no relief to complete relief) to grade the relief of his/her throat pain.~The patient was instructed to swallow and:~“Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now.”"|2 hours|Intent to treat population of participants who had a 2 hour assessment.|||percentage of participants|||Number
1425765|NCT01048424|Secondary|Percent Change in Daytime Voiding Frequency.|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|Baseline to 6 weeks||||Percent Change||Standard Deviation|Mean
1425634|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner’s Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -116196 (no pain at any post-dose time (0) – average baseline) to 27804 (maximum possible pain (100) – average baseline).~Participants with their last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication (acetaminophen 650mg was allowed as needed), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation."|baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)|Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.|||units on a scale||Standard Deviation|Mean
1425635|NCT01049334|Secondary|Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)|"Investigators assessed the effectiveness of study medication on the patient's sore throat at the end of the study by answering the following question: Considering the patient's response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent."|Day 7|Intent to treat population of participants who had an end of study assessment.|||percentage of participants|||Number
1425636|NCT01049334|Secondary|Participant Satisfaction Scores 24 Hours After Initial Dose|After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.|24 hours|Intent to treat population. Three participants withdrew before the 24 hour assessment.|||percentage of participants|||Number
1425637|NCT01049334|Secondary|Investigators’ Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose|Investigators assessed the effectiveness of study medication on the patient’s sore throat at 24 hours following initial dose by answering the following question: “Considering the patient’s response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat?” Responses were poor, fair, good, very good or excellent.|24 hours|Intent to treat population. Three participants withdrew before the 24 hour assessment.|||percentage of participants|||Number
1425638|NCT01049334|Secondary|Practitioner’s Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose|P.A.I.N is a four step scale in which physicians rate the severity of pharyngeal inflammation: No inflammation, mild, moderate and severe inflammation.|24 hours post-dose|Intent to treat population. Three participants withdrew before the 24 hour assessment.|||participants|||Number
1425639|NCT01049334|Secondary|Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8|"Tonsillo-Pharyngitis Assessment, or TPA, is an index of seven clinical features of the pain-producing condition itself, pharyngeal inflammation. The clinical features concern temperature, oropharyngeal color, size of tonsils, number of enanthems, largest size of cervical lymph node, number of lymph nodes, and maximum tenderness of lymph nodes. Each variable was rated on a scale of 0-3, with 0 representing the normal value, and 3 representing severe inflammation. The seven values are added together to create the TPA, ranging from 0-21.~Negative change values represent improvement of symptoms."|Baseline (pre-dose), 24 hours post-dose|Intent to treat population of participants whose baseline TPA was >=8 and had an assessment at hour 24.|||units on a scale||Standard Deviation|Mean
1425640|NCT01049334|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline|"The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and specified timeframes until 24 hours.~The patient was instructed to swallow and “Place a line on the scale that best characterizes how swollen your throat feels now.” A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -112032 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31968 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS."|baseline (pre-dose), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours)|Intent to treat population of participants who took the first full dose of medication, and had SwoTS recorded after 21 hours. Four participants (1 Flurbiprofen, 3 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1425641|NCT01049334|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline|"The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours.~The patient was instructed to swallow and “Place a line on the scale that best characterizes how swollen your throat feels now.” A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9336 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2664 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS."|baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
1425710|NCT01048723|Secondary|Number of Participants With Pathological Response|We planned to determine pathological response in terms of tumor necrosis and apoptosis assessed on the resected specimens after 2 weeks of RAD001 therapy. Percent necrosis was to be reported based on the routine H and E staining. In addition to cleaved PARP analysis, TUNEL assays were to be performed judging the amount of apoptosis in the specimens after treatment. Our planned analysis was for 40 participants.|Post the 2 week treatment|||||||
1425642|NCT01049334|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline|"Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and until 24 hours post dose.~Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -110304 (no difficulty swallowing within 10 minutes of dosing that lasts 24 hours) to 33696 (maximum difficulty swallowing within 10 minutes lasting 24 hours) using the baseline DSS value.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|baseline (pre-dose), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours)|Intent to treat population of participants who took the first full dose of medication and had DSS recorded after 21-hours.|||units on a scale||Standard Deviation|Mean
1425643|NCT01049334|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline|"Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and 2 hours post dose.~Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9192 (no difficulty swallowing within 10 minutes of dosing that lasts 2 hours) to 2808 (maximum difficulty swallowing within 10 minutes lasting 2 hours) using the baseline DSS value.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
1425644|NCT01049334|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dosing. The full range was -9405 (complete pain relief within 2 minutes of dosing that lasts 2 hours) to 2395 (maximum pain within 2 minutes lasting 2 hours) using the mean baseline STPIS.~If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2)|Intent to treat population of participants who took the first full dose of medication.|||units on a scale||Standard Deviation|Mean
1425645|NCT01049334|Primary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)|STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time-weighted pain intensity differences from baseline until 24 hours. The full range was -114609 (complete pain relief within 2 minutes of dosing that lasts 24 hours) to 29191 (maximum pain within 2 minutes lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.|baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)|Intent to treat population of participants who took the first full dose of medication. Three participants (1 Flurbiprofen, 2 Placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint (no entries after 2 hours), but did have sufficient data to be included in other efficacy analyses.|||units on a scale||Standard Error|Least Squares Mean
1425646|NCT01049308|Secondary|Medication Adherence|"To capture both overtaking and undertaking medication, a delta was determined for each medication by computing the absolute difference between the number of pills taken and the number prescribed over the 30-day period. The delta values for each medication were summed for each individual subject, divided by the total number of pills prescribed, subtracted from 1, and finally multiplied by 100 to obtain an adherence score expressed as a percentage."|30 days||||percentage of adherence||95% Confidence Interval|Mean
1425647|NCT01049308|Primary|SLUMS Scores|SLUMS (Saint Louis University Mental Status) exam is a validated screening test for cognitive impairment (CI) consisting of 30-point interview scale. SLUMS is considered positive for mild CI if the score is <27 in a person with a high school diploma or <25 in a person who did not complete high school. SLUMS screening is considered positive for severe impairment consistent with dementia if the score is <21 for persons with a high school diploma and <20 for persons who did not complete high school.|baseline collection||||scores on a scale||Standard Deviation|Mean
1425648|NCT01049243|Secondary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.|Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.|Baseline to 14 days||||units on a scale||95% Confidence Interval|Mean
1425649|NCT01049243|Primary|Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.|Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.|Baseline to 3 days||||Scores on a scale||Standard Deviation|Mean
1425650|NCT01049217|Secondary|Diagnostic Neuropathy Assessment||Screening|Data were not collected since this was a screening tool for investigators and there was no analysis planned for this measure.||||||
1425651|NCT01049217|Other Pre-specified|Number of Participants With Response to Patient Health Questionnaire–8 (PHQ-8)|PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated “Over past 2 weeks, how often bothered by any of following problems?”: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.|Screening|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||participants|||Number
1425652|NCT01049217|Other Pre-specified|Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.|Screening, Post-Baseline (Week 4 up to Week 17)|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||participants|||Number
1425653|NCT01049217|Other Pre-specified|Number of Participants Who Met Mini-International Neuropsychiatric Interview (MINI) Criteria|MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.|Screening|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1425654|NCT01049217|Other Pre-specified|Number of Participants With Neurological Examination Findings|A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities [LE], right and left first metatarsal joint position sense, and vibration sensation [vibration is felt for < 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, > 10 seconds = normal]).|Screening|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.|||participants|||Number
1425655|NCT01049217|Other Pre-specified|Sitting Heart Rate||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||beats per minute (bpm)||Standard Deviation|Mean
1425656|NCT01049217|Other Pre-specified|Sitting Systolic and Diastolic Blood Pressure|Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.|Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1425657|NCT01049217|Other Pre-specified|Body Weight||Screening, Week 1, 4, 8, 12, 16, 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||kilogram||Standard Deviation|Mean
1425658|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities.|Screening, Week 8, 17|Safety population included all participants who signed the informed consent, had exposure to open label study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group.|||participants|||Number
1425659|NCT01049217|Other Pre-specified|Number of Participants With Positive Serum and Urine Pregnancy|Serum pregnancy test (regardless of childbearing potential) and urine pregnancy test for all female participants were performed.|Screening for serum pregnancy test, Week 1 for urine pregnancy test|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1425660|NCT01049217|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported.|Screening up to Week 17|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1425711|NCT01048723|Secondary|PD Markers (p70S6K, S6-RP, P-AKT, Cleaved PARP and PCNA)|Quantitative in vivo and ex vivo assessments of PD markers (p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA) were to be normalized within the same sample. The extent of inhibition is defined as the fractional inhibition in each patient calculated as [(PreRx normalized PD marker – PostRx normalized PD marker) / PreRx normalized PD marker] x 100. Same definition would apply to each of these markers. Our planned analysis was for 40 participants.|Post the 2 week treatment|||||||
1425661|NCT01049217|Other Pre-specified|Number of Participants With Treatment-Emergent (TE) Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after last dose|Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.|||participants|||Number
1425662|NCT01049217|Secondary|Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1425663|NCT01049217|Secondary|Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||hours||Standard Deviation|Mean
1425664|NCT01049217|Secondary|Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire|WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded “Yes/No” to Question 1: Are you currently employed (working for pay)? are reported.|Baseline, Week 16, 17|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.|||participants|||Number
1425665|NCT01049217|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16)|SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1425666|NCT01049217|Secondary|Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16)|HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1425667|NCT01049217|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||participants|||Number
1425712|NCT01048723|Primary|Pharmacodynamics (PD) Markers|PD markers of RAD001 on downstream signaling pathways in patients with sarcomas: p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA by Western blot, quantitative multiplex assays and immunohistochemical studies measured pre and post the 2 week treatment of RAD001. Patients were to be separated into two groups, responders and non responders based on PD results and downstream up regulation of the referenced pathways. Mean fractional inhibition of each PD marker for the responding and non-responding groups were to be calculated. Our planned analysis was for 40 participants.|Pre and post the 2 week treatment|||||||
1425713|NCT01048697|Primary|Total Clearance of Ethambutol||Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours)||||L/h||Standard Deviation|Mean
1425668|NCT01049217|Secondary|Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16)|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1425669|NCT01049217|Secondary|Percentage Day Time Above Sedentary Level|Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (>) 200 activity counts per minute divided by total number of epochs during the “day” (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||percentage of day time||Standard Error|Least Squares Mean
1425670|NCT01049217|Secondary|Total Activity Counts|"Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method."|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||activity counts per day||Standard Error|Least Squares Mean
1425671|NCT01049217|Secondary|Sleep Efficiency|Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||Percent time between sleep onset and end||Standard Error|Least Squares Mean
1425672|NCT01049217|Secondary|Sleep Fragmentation Index (SFI)|SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||percentage of immobile bouts||Standard Error|Least Squares Mean
1425673|NCT01049217|Secondary|Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS)|Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)|ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.|||minutes||Standard Error|Least Squares Mean
1425674|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16)|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1439485|NCT00939107|Secondary|Number of Patients on Sick Leave|Measured by self-report of beeing on sick leave at the moment because of LBP|twelve months posttreatment|Number of patients on sick leave due to LBP pre-treatment.|||Participants|||Number
1425675|NCT01049217|Secondary|Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours [hrs], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||participants|||Number
1425676|NCT01049217|Secondary|Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16)|NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1425677|NCT01049217|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16)|BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.|Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1425678|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current (“right now”) HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1425679|NCT01049217|Secondary|Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16)|Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.|Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1425680|NCT01049217|Secondary|Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC)|The CGIC scale measures a physician’s global impression of a participant’s clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1425681|NCT01049217|Secondary|Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported.|Week 16|ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1425714|NCT01048671|Secondary|Number of Participants With at Least One Adverse Event|An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor’s product whether or not related to the use of the product.|Up to 25 months after start of raltegravir treatment|Participants enrolled and not excluded for a protocol violation were included in the analysis.|||Participants|||Number
1440664|NCT00929695|Secondary|Chronic Extensive GVHD|Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
1425682|NCT01049217|Primary|Change From Baseline in Mean Pain Score at Endpoint (up to Week 16)|Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).|Baseline, Endpoint (up to Week 16)|Intent to Treat (ITT) population: all randomized participants who took at least 1 dose of study drug. Imputation: mBOCF, baseline data was carried forward for participants who discontinued due to adverse events or had no post-baseline observations; otherwise last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1425683|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 24 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|24 weeks||||mL/100 mL/min||Standard Deviation|Mean
1425684|NCT01049009|Primary|Endothelial Function Measured by Forearm Blood Flow (FBF) at 12 Weeks|Forearm blood flow measured by venous occlusion plethysmography at rest, after administration of N(G)-monomethyl-L-arginine (L-NMMA) and tetraethylammonium chloride (TEA), after administration of L-NMMA, TEA, and acetylcholine, and after administration of L-NMMA, TEA, and exercise. Unit of Measure refers to volume of blood (mL) per 100 mL of forearm tissue per minute.|12 weeks||||mL/100 mL/min||Standard Deviation|Mean
1425685|NCT01048944|Primary|Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence|"Changes in log from baseline in the widely used Shiffman-Jarvik Withdrawal craving and psychological symptom scores through 66 days of abstinence. Post-quit changes were assessed at days 3, 24, 45, and 66 of abstinence. The maximal range of value raw for craving is from 5 = (no craving) to 47 (maximally strong craving), while that for psychological symptoms is from 5 (no symptoms) to 60 (maximally intense symptoms of across multiple symptoms). Because the subtraction of logs is equivalent to the ratio of the two scores, a difference in logs (base 10) with a value of 1 is equal to an increase by a factor of 10, while a value of 0 is no change, and values of less than 0 are decreases below baseline values."|Changes in log withdrawal symptoms from baseline through 66 days of abstinence|Analysis population included only those individuals who complied fully with study requirements through 67 days of abstinence.|||log (base 10) units on a scale||Standard Error|Mean
1425686|NCT01048944|Primary|Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit.|Brain-wave activity (EEG) was assessed using electrodes on the subject's scalp, the outputs of which were and quantified by a commercial brain wave machine. EEG was collected at frontal (e.g., Fz) and parietal (e.g., Pz) electrodes while subjects relaxed. EEG was analyzed using computer programs that measured slow-frequency EEG waves known as delta (1.5-4.5 cycles/second [cps]), theta-1 (4.5-6.0 cps), theta-2 (6.0-7.7 cps), and alpha-1 (7.8-10.0 cps), and higher frequency waves. Generally, delta, alpha-1 and theta waves reflect deactivation of the brain activity, while higher frequency waves reflect greater brain activation. Brain activity was quantified as the natural log of EEG power [microvolts squared] as determined by the fast Fourier mathematical algorithm. Days post quit were components of Time. The primary focus was on changes in the individual subject's log theta-1, theta-2, and alpha-1 power at post-quit points in time minus the log values at the pre-quite baseline.|Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit|For the currently reported analyses, only individuals complying with the study requirements, including biochemically verified smoking abstinence, were assessed. Future analyses will include individuals who complied to certain critical endpoints.|||Change in log EEG [microvolts squared]||Standard Error|Mean
1425687|NCT01048879|Primary|Oseltamivir Carboxylate Removal by ECMO|Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.|12 hours|All of the patients that received ECMO were included. Patients receiving CVVHD Alone did not receive ECMO and were not included.|||percent change in concentration||Standard Deviation|Mean
1425688|NCT01048879|Primary|Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance|Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).|12 hours|One patient in the CVVHD Alone group was excluded from the analysis because not enough data points were available for pharmacokinetic modeling.|||mL/min||Standard Deviation|Mean
1425689|NCT01048866|Secondary|Change From Baseline in Body Temperature at End of Study||baseline (pre-dose), up to Day 7|Safety population of participants with a recording at the end of study visit.|||degrees Fahrenheit||Standard Deviation|Mean
1425690|NCT01048866|Secondary|Change From Baseline in Body Temperature at 2 Hours Post Initial Dose||baseline (pre-dose), 2 hours post-dose|Safety population|||degrees Fahrenheit||Standard Deviation|Mean
1425691|NCT01048866|Secondary|Time to First Rescue Pain Medication|Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment during the study. Time from initial dose to first rescue medication is summarized by time categories.|Days 1-7|Intent to treat population|||percentage of participants|||Number
1425692|NCT01048866|Secondary|Percentage of Participants Who Took Rescue Pain Medication|Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.|Days 1-7|Intent to treat population|||percentage of participants|||Number
1425693|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing|"Participants graded the relief of his/her sore throat at 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.~The patient was instructed to swallow and:~“Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now.” Responses following each lozenge were no relief, slight, mild, moderate, considerable, and complete relief. Results summarize responses 2 hours after taking each lozenge."|Days 2-7|Intent to treat population of participants who were active in the study on day 2|||percentage of doses|Lozenges (doses)||Number
1455522|NCT00811317|Secondary|Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals||After each of 3 meals||||percentage of time||Standard Deviation|Mean
1425694|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)|"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.~The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose.~The patient was instructed to swallow and “Place a line on the scale that best characterizes how swollen your throat feels now.” A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. Data for multiple doses/days were averaged to obtain the values used for calculating SWoTS2. The full range for differences was -5396 to 6604 with negative values indicating improvement in pain intensity.~Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2|||units on a scale||Standard Error|Least Squares Mean
1425695|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)|"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.~To measure the functional effect on pharyngitis, the participant was asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose. The participant was instructed to swallow and “Place a line on the scale that best characterizes how difficult it is to swallow now.” A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data for multiple doses/days were averaged to obtain the values used for calculating DSS2. The full range for differences was -5626 to 6374 with negative values indicating improvement in pain intensity.~Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.|||units on a scale||Standard Error|Least Squares Mean
1425696|NCT01048866|Secondary|Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)|"The time weighted summed differences over 2 hours after taking a lozenge after the initial 24-hours post-baseline.~STPIS is a validated 100-mm visual analog scale completed by participants that measures “pain on swallowing” (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from a measurement taken prior to taking a lozenge and at hours 1 + 2 after taking the lozenge during Days 2-7. Data for multiple doses/days were averaged to obtain the values used for calculating SPID2. The full range for SPID2 was -5843 to 6157 with negative values indicating improvement in pain intensity. Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants."|Days 2-7|Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.|||units on a scale||Standard Error|Least Squares Mean
1425697|NCT01048866|Secondary|Investigators’ Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)|Investigators assessed the effectiveness of study medication on the patient’s sore throat at the end of study by answering the following question: “Considering the patient’s response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat?” Responses were poor, fair, good, very good or excellent.|Day 7 (end of study)|Intent to treat population of participants who completed the study. CLIN was missing for one flurbiprofen participant.|||percentage of participants|||Number
1425698|NCT01048866|Secondary|Participant Satisfaction Score 24 Hours After Initial Dose|After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.|24 hours|Intent to treat population. One placebo participant did not complete a Patient Satisfaction Score.|||percentage of participants|||Number
1425699|NCT01048866|Secondary|Investigators’ Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose|Investigators assessed the effectiveness of study medication on the patient’s sore throat at 24 hours following initial dose by answering the following question: “Considering the patient’s response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat?” Responses were poor, fair, good, very good or excellent.|24 hours|Intent to treat population. CLIN was not performed for 3 participants (1 Flurbiprofen, 2 placebo).|||percentage of participants|||Number
1425700|NCT01048866|Secondary|Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose|"Participants graded the relief of his/her sore throat at 2 hours post initial dose using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.~The patient was instructed to swallow and asked:~“Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now.” Responses were no relief, slight, mild, moderate, considerable, and complete relief."|2 hours|Intent to treat population|||percentage of participants|||Number
1425701|NCT01048866|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner’s Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -115695 (no pain at any post-dose time (0) – average baseline) to 28505 (maximum possible pain (100) – average baseline).~Participants with their last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imput"|baseline (pre-dose), 24 hours post dose (measured each hour post dose)|Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.|||units on a scale||Standard Deviation|Mean
1425702|NCT01048866|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9492 (complete pain relief within one hour of dosing that lasts 2 hours) to 2508 (maximum pain within 1 hour lasting 2 hours) using the mean baseline STPIS.~If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), post-dose: 1 hour, 2 hours|Intent to treat population|||units on a scale||Standard Deviation|Mean
1425703|NCT01048866|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline|"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.~The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -100320 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31680 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS. Negative values for differences indicate improvement."|Baseline (pre-dose), hourly readings to 24 hours post-dose|Intent to treat population. Four participants (2 Flurbiprofen, 2 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1425704|NCT01048866|Secondary|Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline|"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.~The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9120 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2880 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS.~Negative values for the differences indicate improvement. Missing values of SwoTS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), hourly readings to 2 hours post-dose|Intent to treat population of participants who took the first full dose of medication|||units on a scale||Standard Deviation|Mean
1425705|NCT01048866|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline|"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.~Data are reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -102960 (no difficulty swallowing within 1 hour of dosing that lasts 24 hours) to 29040 (maximum difficulty swallowing within 1 hour of dosing lasting 24 hours) using the baseline DSS value. Negative values indicate improvement in difficulty swallowing.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), hourly readings to 24 hours post-dose|Intent to treat population. Four participants (2 Flurbiprofen and 2 placebo) did not have DSS recorded after 21 hours and were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1425706|NCT01048866|Secondary|Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline|"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.~Data are reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9360 (no difficulty swallowing within 1 hour of dosing that lasts 2 hours) to 2640 (maximum difficulty swallowing within 1 hour of dosing lasting 2 hours) using the baseline DSS value.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation."|Baseline (pre-dose), Hours 1 and 2 post-dose|Intent to treat population of participants who took the first full dose of medication|||units on a scale||Standard Deviation|Mean
1425707|NCT01048866|Primary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)|"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS.~Participants with a last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose."|baseline (pre-dose), post-dose - hourly up to 24 hours|Intent to treat population of participants who took the first full dose of medication, and had STPIS values recorded >= 21 hours post initial dose. Four participants (2 Flurbiprofen, 2 placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint.|||units on a scale||Standard Deviation|Mean
1425708|NCT01048788|Primary|Body Weight|Changes in body weight from baseline at the end of administration|Baseline, Day 14 or end of administration||||Kg||Standard Deviation|Mean
1425709|NCT01048723|Secondary|Number of Participants With Memory CD8 T Cell Enhanced Production|Memory CD8 T cell enhanced production as determined by fluorescence activated cell sorter (FACS) analysis on blood and tumor core biopsy specimens taken before and after therapy with RAD001. Our planned analysis was for 40 participants.|Pre and Post the 2 week treatment|||||||
1425715|NCT01048671|Primary|Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||cells/mm^3||95% Confidence Interval|Mean
1425716|NCT01048671|Primary|Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants||Baseline and 24 months after start of raltegravir treatment|All participants with a CD4 cell count available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||cells/mm^3||95% Confidence Interval|Mean
1425717|NCT01048671|Primary|Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available and receiving raltegravir treatment at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||Percentage of participants||95% Confidence Interval|Number
1425718|NCT01048671|Primary|Percentage of Participants Responding to Treatment: All Treated Participants|Response to treatment was defined as a viral load <50 RNA copies/mL|24 months after start of raltegravir treatment|All participants with a viral load assessment available at 24 months were included in the analysis. A single treatment arm was specified in the study, but participants were sub grouped by their prior ARV experience at Baseline (ARV naïve, suppressed, or virological failure) for analysis.|||Percentage of participants||95% Confidence Interval|Number
1425719|NCT01048671|Primary|Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.|Up to 25 months after start of raltegravir treatment|Two participants were excluded for protocol violation (inclusion criterion not met) and data were missing for 3 additional participants.|||Percentage of participants|||Number
1425720|NCT01048658|Secondary|Patient and Provider Satisfaction With Anesthesia|Scores reported on 10-cm Visual Analog Scale (VAS anchors: 0= not satisfied at all, 10= completely satisfied) . Reported as mean +/- standard deviation. Subjects and providers were blinded to anesthesia method. Subjects and providers completed post-operative questionnaire within 30 minutes of procedure completion.|Post-procedure, within 30 minutes||||cm||Standard Deviation|Mean
1425721|NCT01048658|Secondary|Number of Participants Experiencing Side Effects (Nausea, Dizziness)||Post-procedure, within 30 minutes||||Participants|||Count of Participants
1425722|NCT01048658|Secondary|Procedure Time: T-test (Time of Speculum Placement to Time Speculum Removed)|Length of procedure from time of speculum placement to time of speculum removal, in minutes.|Time of speculum place to time of speculum removal, an average of 7.1 minutes||||minutes||Standard Deviation|Mean
1425723|NCT01048658|Secondary|Number of Participants With Estimated Blood Loss Greater Than 300 mL (Yes/no)|Procedural blood loss greater than 300 mL. Blood loss was measured in a standardized fashion (amniotic fluid was discarded, blood was separated from tissue, and all gauze surgical drapes weighed).|At time of uterine evacuation, an average of 7.1 minutes||||Participants|||Count of Participants
1425724|NCT01048658|Primary|Number of Participants Needing Intervention to Treat Blood Loss (a Composite of Use of Uterotonics, Re-aspiration, and Bimanual Massage)|Provider report for need to intervene due to blood loss (yes/no)|At time of uterine evacuation and immediately post-operatively, an average of 7.1 minutes||||Participants|||Count of Participants
1425725|NCT01048606|Secondary|Physical Capacity: 3 Tests From the Senior Fitness Test (Chair Stand Test, Chair Sit-and-Reach Test, Back Scratch Test) + Handgrip Strength Test (Lafayette Hand Dynamometer, Indiana)||0, 6 and 12 months|||||||
1425726|NCT01048606|Secondary|Maximal Oxygen Uptake Measured Using a Continuous, Incremental Protocol (Balke Modified Protocol) on a Treadmill With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA).||0 and 12 months|||||||
1425727|NCT01048606|Secondary|Metabolic Rate at Rest: During 30 Minutes With a Breathing Mask by Indirect Calorimetry (CCM/D, Medgraphics Corp, St-Paul, MN, USA) After a 12-hour Fast, in the Early Morning.||0, 6 and 12 months|||||||
1425728|NCT01048606|Secondary|Plasma Isoflavones (Diadzein) - a Marker of Phytoestrogen Compliance - Will be Measured by the ELISA Method||0, 6 and 12 months|||||||
1425729|NCT01048606|Secondary|Physical Activity Level: Physical Activity Scale for the Elderly (PASE)||0, 6 and 12 months|||||||
1425730|NCT01048606|Secondary|Dietary Intakes: 3-days Food Record. Dietary Analyses Will be Completed Using the Nutifiq Software (Université Laval)||0, 6 and 12 months|||||||
1425731|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||12 months|||||||
1425732|NCT01048606|Primary|Plasma Fibrinogen Levels Measured With Luminescence.||6 months|||||||
1425733|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||12 months|||||||
1425734|NCT01048606|Primary|Quality of Life: Assessed With Questionnaires (SF-36 (General Health Perceptions), Kupperman Index, Perceived Stress Scale||6 months|||||||
1425735|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||12 months|||||||
1425736|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||6 months|||||||
1425737|NCT01048606|Primary|Sex-hormone Levels. Estradiol, Estrone, Progesterone, Testosterone and SHBG Will be Obtained by Enzyme Immuno Assay (EIA)||Baseline|||||||
1425738|NCT01048606|Primary|Markers of Oxidative Stress: Conjugated Diene Formation, Malondialdehyde, Alpha-tocopherol and Its Oxidised Form Alpha-tocopheryl Quinone. TAS Constitutes the Most Reliable Method for the Evaluation of Oxidative Stress in Vivo.||12 months|||||||
1425767|NCT01048424|Primary|Percent Change in Urgency Urinary Incontinence Episodes Per Week|The number of incontinence episodes per week was calculated only over a 1-week period before the 6-week visit. There were no other interim outcomes assessment timepoints.|baseline to 6 weeks||||Percent Change||Standard Deviation|Mean
1425768|NCT01048333|Secondary|Adverse Events|Number of participants with at least 1 AE.|At baseline and at each day of treatment||||Participants|||Number
1425769|NCT01048333|Secondary|Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1|Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1|Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose||||Percentage of Participants|||Number
1425770|NCT01048333|Secondary|Average FEV1 During 120 Minutes Post Dose|Average FEV1 during 120 minutes post dose, change versus pre dose FEV1|Pre dose and 120 minutes post dose||||percentage change||95% Confidence Interval|Geometric Mean
1425771|NCT01048333|Secondary|Average FEV1 During the First 15 Minutes Post Dose|Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1|Pre dose and 15 minutes post dose||||percentage change||95% Confidence Interval|Geometric Mean
1425772|NCT01048333|Primary|FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose|FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1|Pre-dose and 5 minutes post-dose||||percentage change||95% Confidence Interval|Geometric Mean
1425773|NCT01048242|Primary|Sleep Onset Latency|Time to sleep onset as determined by polysomnography|4 weeks|analysis per protocol|||minutes||Standard Deviation|Mean
1425774|NCT01048125|Primary|Identifying Risk Factors and Developing Strategies to Prevent the Occurrence of Stress Cardiomyopathy in Situations Where the Likelihood in Susceptible Individuals May be High.||2 years|Due to difficulty in recruitment and resource restraints the study did not progress as expected and was closed.||||||
1425775|NCT01048099|Primary|Part II: Objective Response Rate of Pertuzumab Therapy|The percentage of patients with HER2 activation (no overexpression) as identified by the PRO Onc Assay who experience an objective benefit from treatment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes patients with only HER2 activation (no overexpression) as detected by the PRO Onc Assay|||percentage of participants|||Number
1425776|NCT01048099|Primary|Part II: Objective Response Rate of Trastuzumab Therapy|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression as identified by the PRO Onc Assay.|18 months|Includes patients with HER2 overexpression detected by the PRO Onc Assay|||percentage of participants|||Number
1425777|NCT01048099|Secondary|Part I: The Incidence of Isolation of Circulating Tumor Cells (CTCs) From Blood Specimens|Percentage of HER2-negative MBC patients (identified by FISH testing) having CTCs present in blood specimens.|12 months|Includes all patients with blood drawn and analyzed for CTCs|||percentage of participants|||Number
1425778|NCT01048099|Primary|Part II: Objective Response Rate of HER2-negative Metastatic Breast Cancer (by FISH Testing)|The percentage of HER2-negative metastatic breast cancer (MBC) patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Includes patients with HER2 overexpression/activation as detected by PRO Onc Assay.|18 months||||percentage of participants|||Number
1425779|NCT01048099|Secondary|Part 1: The Incidence of HER2 Overexpression/Activation as Measured by the PRO Onc Assay|Includes patients with HER2-negative metastatic breast cancer (MBC) as determined by FISH testing.|12 months||||participants|||Number
1425780|NCT01047839|Secondary|SCRs and GMTs at Day 56 and Month 7 Stratified According to Dose Groups and Age Groups||at Day 56 and Month 7|||||||
1425781|NCT01047839|Secondary|GMTs for JEV Neutralizing Antibodies Measured Using a Validated PRNT at Day 56 and Month 7||at Day 56 and Month 7|||||||
1425782|NCT01047839|Secondary|SCRs as Defined as Percentage of Subjects With JEV Neutralizing Antibody Titers of PRNT 50 >= 1:10 at Day 56 and Month 7, Measured Using a Validated Plaque Reduction Neutralization Test (PRNT)||at Day 56 and Month 7|||||||
1425783|NCT01047839|Secondary|Rate of Subjects With Abnormal Laboratory Parameters up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and up to Month 7|||||||
1425784|NCT01047839|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7 After the First Vaccination||up to Day 56 and upt to Month 7|||||||
1425785|NCT01047839|Secondary|Rate of Subjects With Solicited Local and Systemic aEs Assessed With a Subject Diary for 7 Consecutive Days After Each Vaccination||7 days|||||||
1425786|NCT01047839|Secondary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Month 7 After the First Vaccination||up to Month 7|||||||
1425787|NCT01047839|Primary|Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination|Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.|until Day 56||||percentage of participants||95% Confidence Interval|Number
1425788|NCT01047709|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of presumed sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The relative treatment effect on AHI using GEE modeling.|1 day||||events/hr||Inter-Quartile Range|Median
1425800|NCT01047553|Primary|ECG Variables RR Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
1455523|NCT00811317|Secondary|Peak Hyperglycemia Following Each Meal||After each of 3 meals||||mg/dl||Standard Deviation|Mean
1425789|NCT01047553|Secondary|St George’s Respiratory Questionnaire (SGRQ) Total Score|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
1425790|NCT01047553|Secondary|Use of SABA (Salbutamol) as Reliever Medication|The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Times/Day||Standard Deviation|Mean
1425791|NCT01047553|Secondary|Number of COPD Exacerbations Over the Treatment Period|A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment was presented here.|Daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||number of exacerbations|||Number
1425792|NCT01047553|Secondary|Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score|The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
1425793|NCT01047553|Secondary|Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
1425794|NCT01047553|Secondary|Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Mean
1425795|NCT01047553|Secondary|Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms|There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||units on a scale||Standard Deviation|Median
1425796|NCT01047553|Secondary|Evening Peak Expiratory Flow (PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Liter/minute (L/min)||Standard Deviation|Mean
1425797|NCT01047553|Secondary|Morning Peak Expiratory Flow(PEF)|The change from Run-in period average to Treatment period average for each treatment group|Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Liter/minute (L/min)||Standard Deviation|Mean
1425798|NCT01047553|Secondary|Forced Vital Capacity (FVC)|The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||Percentage of baseline||Full Range|Geometric Mean
1425799|NCT01047553|Secondary|Forced Expiratory Volume in One Second (FEV1)|The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group|Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any efficacy data after randomisation were available were included in the efficacy population (Full Analysis Set: FAS).|||percentage of baseline||Full Range|Geometric Mean
1425801|NCT01047553|Primary|ECG Variables QTcF Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
1425802|NCT01047553|Primary|ECG Variables - QTcB Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
1425803|NCT01047553|Primary|ECG Variables - QT Interval|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||milisecond||Standard Deviation|Mean
1425804|NCT01047553|Primary|ECG Variables - Heart Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||beats/min||Standard Deviation|Mean
1425805|NCT01047553|Primary|Vital Signs - Pulse Rate|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||beats/minute||Standard Deviation|Mean
1425806|NCT01047553|Primary|Vital Signs- Sitting DBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mmHg||Standard Deviation|Mean
1425807|NCT01047553|Primary|Vital Signs- Sitting SBP|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mmHg||Standard Deviation|Mean
1425808|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dl||Standard Deviation|Mean
1425809|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Protein|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||g/dl||Standard Deviation|Mean
1425810|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Albumin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||g/dl||Standard Deviation|Mean
1425811|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S- Calcium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dl||Standard Deviation|Mean
1425812|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Potassium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mEq/L||Standard Deviation|Mean
1425813|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Sodium|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mEq/l||Standard Deviation|Mean
1425814|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dL||Standard Deviation|Mean
1425815|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Creatinine|Change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||mg/dL||Standard Deviation|Mean
1425816|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||U/l||Standard Deviation|Mean
1425817|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||U/l||Standard Deviation|Mean
1425818|NCT01047553|Primary|Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||U/l||Standard Deviation|Mean
1425923|NCT01046695|Secondary|Satisfaction With Pain Control at 48 Hours|Pain control was measured by using a Visual Analog Scale (VAS) with a range from 0-10; with 0 being very satisfied and 10 being very dissatisfied.|48 hours after awakening from video-assisted thoracic surgery|11 participants on each arm did not complete the VAS.|||participants|||Number
1425819|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Neutrophils|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Neutrophil||Standard Deviation|Mean
1425820|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Monocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Monocyte||Standard Deviation|Mean
1425821|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Lymphocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Lymphocyte||Standard Deviation|Mean
1425822|NCT01047553|Primary|Clinical Laboratory Test: Haematology Basophil|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Basophil||Standard Deviation|Mean
1425823|NCT01047553|Primary|Clinical Laboratory Test: Haematology Eosinophils|Change from baseline|baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||percentage of Eosinophil||Standard Deviation|Mean
1425824|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Platelet Count|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||Platelet Count x10000/μl||Standard Deviation|Mean
1425825|NCT01047553|Primary|Clinical Laboratory Test: Haematology-Leucocytes|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||leukocyte count/µL||Standard Deviation|Mean
1425826|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Haemoglobin|Change from baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||g/dL||Standard Deviation|Mean
1425827|NCT01047553|Primary|Clinical Laboratory Test: Haematology -Erythrocytes|Mean change from Baseline|Baseline and week 52|All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.|||erythrocytes counts x10000/μl||Standard Deviation|Mean
1425828|NCT01047527|Primary|Week 24 Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|24-week|This analysis was planned to replicate the previous study (Schnoll et al., 2010; Annals of Internal Medicine).|||participants|||Number
1425829|NCT01047527|Primary|Point Prevalence Abstinence|self-reported abstinence from smoking for 7 days prior to the assessment and biochemically confirmed with breath carbon monoxide|52-week|The primary objective of this study was to examine the benefits in terms of cessation of 52-weeks of treatment compared to 8 or 24 weeks.|||participants|||Number
1425830|NCT01047475|Primary|The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)|The primary efficacy analysis, the incidence of best overall response during the study period, was based on the Fisher’s exact test for the binary response that was used to test for the differences in the treatment efficacy between MB-6 and Placebo.|16 weeks||||percentage of Best overall Response||95% Confidence Interval|Median
1425831|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose|Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication|12 h (hours) after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h|||Percent reduction||Full Range|Median
1425832|NCT01047436|Primary|Time for Parasite Count to Fall by 50% PCT(50)|The time taken for the parasite count to fall 50% from baseline|3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h||||hours||Standard Deviation|Mean
1425833|NCT01047436|Secondary|Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose|Reduction in parasitaemia from baseline at 24 h after the first dose of study medication|24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h or 24 h|||Percent reduction||Full Range|Median
1425834|NCT01047436|Primary|Time for Parasite Count to Fall by 90% PCT(90)|The time taken for the parasite count to fall 90% from baseline|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h||||hours||Standard Deviation|Mean
1425835|NCT01047436|Secondary|Parasite Clearance Time|Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained|3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h||||Hours||Standard Deviation|Mean
1425836|NCT01047436|Primary|Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose||24 hours after first dose|For the efficacy endpoints, the analysis was based on the Full Analysis Set (FAS) which was defined as all patients that received at least 1 dose of trial medication and had at least 1 post dose parasite count at 12 h (hours) or 24 h after start of treatment.|||participants|||Number
1425922|NCT01046695|Primary|Mean Pain Score|Pain was measured by using the Visual Analog Scale (VAS) with a range from 1-10; with 0 being no pain and 10 being severe pain. Pain scores were measured from hour 1 to hour 48 for each patient. Some scores were missed when patients were asleep. In these cases, the previous score was used.|hour 1 to hour 48 after awakening from video-assisted thoracic surgery||||units on a scale||Standard Deviation|Mean
1425837|NCT01047358|Secondary|Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)|The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.|At the end of the study, average of 5.6 months|Efficacy Analysis Set.|||Percentage of Participants|||Number
1425838|NCT01047358|Secondary|Time-to-Progression (Early Breast Cancer)|Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.|At the end of the study, average of 5.6 months|This outcome was planned to be analyzed in participants with early breast cancer in the efficacy analysis set. However, the analysis was not performed because the data of time-to-progression was not captured in the CRF.||||||
1425839|NCT01047358|Secondary|Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)|The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant’s case report form (CRF).|At the end of the study, average of 5.6 months.|Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available.|||Percentage of Participants|||Number
1425840|NCT01047358|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.|From the first dose of Aromasin through the end of the study for an average of 5.6 months|Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once.|||Percentage of Participants|||Number
1425841|NCT01047345|Other Pre-specified|Percentage of Participants Who Experience an SAE- Extension Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to Month 7 - Extension Study|All participants who received at least 1 vaccination in Extension Study and had available follow-up data.|||Percentage of Participants|||Number
1425842|NCT01047345|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7; End of Base Study)|Participants who received all 3 vaccinations within an acceptable day range, had Month 7 serology sample collected within an acceptable range and had no other protocol violations that could interfere with immunes response to the vaccine. Statistical testing performed only within the 9vHPV arm and only for HPV types 31, 33, 45, 52, and 58.|||Percentage of Participants||95% Confidence Interval|Number
1425843|NCT01047345|Primary|Percentage of Participants Who Experience a Severe Injection-site AE – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter >2 inches (>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
1425844|NCT01047345|Primary|Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study– Base Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention. An SAE that is judged by the Investigator to be “definitely related,” “probably related,” or “possibly related” is defined as a vaccine-related SAE.|Up to 7 months - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
1425845|NCT01047345|Primary|Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination – Base Study|An SAE is one that results in death, disability/incapacity, or hospitalization or is life threatening, a congenital anomaly or birth defect, cancer, an overdose, or otherwise jeopardizes the participant and may require medical intervention.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
1425846|NCT01047345|Primary|Percentage of Participants Who Experience a Systemic AE – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 14 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
1455524|NCT00811317|Secondary|Percentage of Time Spent Within 70-180 mg/dl||24 hours||||percentage of time||Standard Deviation|Mean
1425847|NCT01047345|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) – Base Study|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available temperature data.|||Percentage of Participants|||Number
1425848|NCT01047345|Primary|Percentage of Participants Who Experience an Injection-site Adverse Event (AE) – Base Study|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who reported an AE that was associated with the injection site such as redness, swelling, and pain/tenderness/soreness was summarized.|up to 5 days after any vaccination - Base Study|All participants who received at least 1 vaccination and had available follow-up data.|||Percentage of Participants|||Number
1425849|NCT01047332|Secondary|Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism|Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.|||participants|||Number
1425850|NCT01047332|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.|From time of stent placement to participant death or lost to follow-up (up to 1302 days)|All randomized participants.|||Participants|||Count of Participants
1425851|NCT01047332|Secondary|Patient Survival|Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.|||days||Inter-Quartile Range|Median
1425852|NCT01047332|Primary|Time to Recurrent Biliary Obstruction|Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.|Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm|All randomized participants.|||days||Inter-Quartile Range|Median
1425853|NCT01047306|Other Pre-specified|Change From Baseline in Phosphorylated Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF phosphorylated tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that phosphorylated tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||picograms/milliliter||Standard Deviation|Mean
1425854|NCT01047306|Other Pre-specified|Change From Baseline in Total Tau Levels in Cerebrospinal Fluid (CSF)|Tau proteins are involved in the building and stabilization of axonal microtubules in the CNS. The phosphorylation of tau proteins associated with microtubules is believed to be involved in destabilizing axons and extensively phosphorylated tau (ptau) has been observed in patients with Alzheimer disease and other neurodegenerative diseases. Because MPS IIIA is a neurodegenerative disease, CSF tau levels were determined to evaluate the potential role of this process in the natural history of the disease. A negative value indicates that total tau levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||picograms/milliliter||Standard Deviation|Mean
1425855|NCT01047306|Secondary|Change From Baseline in The Total Sleep Disturbance (TSD) Score of The Children’s Sleep Habits Questionnaire (CSHQ)|The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. The questionnaire was designed for children aged 4 to 12 years. Parents were asked to think of a recent “typical” week of their child’s sleep and to indicate how often sleep disturbance behaviors occurred. A 3-point scale was used for rating: “usually” if the sleep behavior occurs 5 to 7 times per week, “sometimes” for 2 to 4 times per week, and “rarely” for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||units on a scale||Standard Deviation|Mean
1425883|NCT01047306|Other Pre-specified|Change From Baseline in Urine Glycosaminoglycan (GAG) Levels|Urine GAG was measured by a dye binding assay. A negative value indicates that GAG levels decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||mg GAG/mmol creatinine||Standard Deviation|Mean
1455525|NCT00811317|Primary|Average Blood Glucose Over the Closed-loop Control Period||24 hours||||mg/dl||Standard Deviation|Mean
1425856|NCT01047306|Secondary|Change From Baseline in The Infant Toddler Quality of Life Questionnaire (ITQoL) Growth And Development Subscale|The ITQoL Questionnaire is a generic, validated health status measure for children aged 2 months up to 5 years, including items and scales to measure aspects of physical functioning, development, pain, mood, behavior, general health, and impact on parents. In this study the ITQoL was also administered to patients who were developmentally functioning at or below the age of years. Growth and development is one of 12 health concepts measured by ITQoL. Transformed scores for all subscales range from 0 to 100, with a higher score indicating better health. A positive value indicates improvement.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||units on a scale||Standard Deviation|Mean
1425857|NCT01047306|Secondary|"Number of Participants With Somewhat or Much Worse Change in Health as Assessed by The Child Health Questionnaire Parent Form 50 (CHQ-PF50)"|The parent form, CHQ-PF50, is designed to measure the physical and psychosocial well-being of children 5 years and older. In this trial it was used to assess the health of children 5 to 18 years of age. It consists of 13 health concepts including 11 multi-item and 2 single-item scales: physical function, role/social-emotional/behavioral, role/social-physical, bodily pain, general behavior, mental health, self-esteem, general health perceptions, change in health, parental impact-emotional, parental impact-time, family activities, and family cohesion. The parental impact scales capture the amount of emotional distress and time limitation experienced by the parent due to the child’s physical health, emotional well-being, attention/learning abilities, ability to get along with others, and general behavior. The Change in Health section assesses changes in health over the previous year.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||participants|||Number
1425858|NCT01047306|Post-Hoc|Change From Baseline in Spleen Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Spleen volume was assessed via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||milliliters||Standard Deviation|Mean
1425859|NCT01047306|Post-Hoc|Change From Baseline in Liver Volume as Assessed by Abdominal Magnetic Resonance Imaging (MRI)|Liver volume was obtained via abdominal MRI. A negative value indicates that volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||milliliters||Standard Deviation|Mean
1425860|NCT01047306|Post-Hoc|Change From Baseline in The Ratio of Mitral Valve Early Inflow Velocity (E) to Late Inflow Velocity (A)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Blood flow through the mitral valve is measured during one heartbeat.The E/A ratio measures the relationship between early (E) and late (A) inflow velocity by dividing E by A. A positive value indicates that either early flow through the mitral valve (E) increased or late flow through the valve (A) decreased.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||quotient of E/A||Standard Deviation|Mean
1425861|NCT01047306|Post-Hoc|Change From Baseline in Tricuspid Valve Regurgitant Velocity|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Backwards blood flow through the tricuspid valve is measured during one heartbeat. A negative value indicates decreased velocity.|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||meters/second||Standard Deviation|Mean
1425862|NCT01047306|Post-Hoc|Percent of Participants With Trace Regurgitation as Assessed by ECG|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit. Regurgitation indicates that blood flows backwards through the valve.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425863|NCT01047306|Post-Hoc|Percent of Participants With Thickened Heart Valves as Assessed by Echocardiography (ECG)|ECG allows a non-invasive assessment of cardiac structure, function, and hemodynamics and can provide essential insight into mechanisms of disease and therapeutic benefit.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425864|NCT01047306|Secondary|Percent of Participants With Profound Hearing Loss, as Assessed by the Auditory Brainstem Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Profound hearing loss: 91+ decibels hearing level (dBHL).|Baseline, 6 months, 12 months, End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||percentage of participants|||Number
1425921|NCT01046877|Primary|Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.|TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.|Procedural|One subject was missing data on intraprocedural adverse events and is excluded from this analysis.|||percentage of ears|Participants|95% Confidence Interval|Number
1425865|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at End of Study, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
1425866|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 12 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
1425867|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at 6 Months, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
1425868|NCT01047306|Secondary|Number of Participants With Mild, Moderate, or Severe Hearing Loss at Baseline, as Assessed by The Auditory Brain Response (ABR)|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. Mild hearing loss: 21-40 decibels hearing level (dBHL), moderate hearing loss: 41-70 dBHL, severe hearing loss: 71-90 dBHL.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||participants|||Number
1425869|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425881|NCT01047306|Secondary|Change From Baseline in The Total Disability Score (TDS) of The Four Point Scoring System (FPSS)|The FPSS is an MPS III-specific disability assessment that evaluates motor function, expressive language, and cognitive function on a 0- to 3- point scale and can be used for individuals of all ages. A score of 3 points is assigned for normal function, 2 points for beginning of regression, 1 point for severe level of regression, and 0 points for lost skills. The total disability score (TDS) is the average of the motor function, speech, and cognitive function scores (range: 0, 3). The scoring is based on the parent’s response to a detailed questionnaire that covers several aspects of the disease. A positive value indicates improvement in function.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||units on a scale||Standard Deviation|Mean
1425870|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425871|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425872|NCT01047306|Secondary|Percent of Participants With Conductive Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Conductive hearing loss occurs when there is a problem conducting sound waves along the route through the outer ear, tympanic membrane, or middle ear. Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (number of neurons firing), latency (speed of transmission), interpeak latency (time between peaks), and interaural latency (difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425873|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at End of Study, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425874|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 12 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425882|NCT01047306|Secondary|Change From Baseline Values in Gray Matter Volume Assessed by Brain Magnetic Resonance Imaging (MRI)|Total brain cortical gray matter volume was determined by analysis of brain MRI. The analysis was performed using “Freesurfer” software, which provides completely automated parcellation of the brain cortex and subcortical structures. In some cases, manual adjustments were necessary in cases of intensity normalization failure, resulting in erroneous white matter segmentation. A negative value indicates that gray matter volume decreased.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||milliliters||Standard Deviation|Mean
1440825|NCT00928720|Secondary|Fatigue Using Lee's Fatigue Scale|A Numeric Rating Scale ranging from 0-10 to capture present levels of fatigue using the fatigue subscale of Lee's Fatigue Scale|Week 8||||units on a scale||Standard Deviation|Mean
1425875|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at 6 Months, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425876|NCT01047306|Secondary|Percent of Participants With Sensorineural Hearing Loss at Baseline, as Assessed by the Auditory Brainstem Response (ABR)|Sensorineural hearing loss occurs from damage to the inner ear, the brain, or the nerve that runs from the ear to the brain (auditory nerve). Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound­evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I­V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia.|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425877|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at End of Study|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|End of Study (12 months assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425878|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 12 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|12 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425879|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at 6 Months|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|6 months|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425880|NCT01047306|Secondary|Percent of Participants With an Abnormal Overall Test Result of Auditory Brainstem Response (ABR) at Baseline|Hearing loss in subjects with MPS IIIA was characterized by assessing the ABR. The ABR is a voltage response evoked by acoustic stimuli as sound is processed along the auditory pathway. It consists of electrical signals resulting from the sum of sound-evoked activity along the auditory nerve and brainstem nuclei. The ABR analysis determines the sound intensity at which a neural response first appears (hearing threshold). Other parameters of interest include amplitude (the number of neurons firing), latency (the speed of transmission), interpeak latency (the time between peaks), and interaural latency (the difference in wave V latency between ears). The interpeak latency I-V interval (or central transmission time) is considered the most reliable index of brainstem function. Auditory brainstem response assessments were conducted under anesthesia. An abnormal value was greater than 21 decibels hearing level (dBHL).|Baseline|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients.|||percentage of participants|||Number
1425884|NCT01047306|Primary|Change From Baseline in VABS-II Overall DQ Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||percentage of chronological age||Standard Deviation|Mean
1425885|NCT01047306|Primary|Change From Baseline in Vineland Adaptive Behavior Scales-II (VABS-II) Age-equivalent Scores|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It is an instrument that supports the diagnosis of intellectual and developmental disabilities in patients from birth to 90 years. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The mean age-equivalent score is obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills (range: 0, unbound). A positive value indicates improvement in health and cognition|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||months||Standard Deviation|Mean
1425886|NCT01047306|Primary|Change From Baseline in BSID-III/KABC-II Developmental Quotient (DQ) Scores|The determination of whether a patient received BSID­III was based on an algorithm that includes the patient's calendar age and VABS­II age ­equivalent score (See Outcome 1). The BSID­III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC­II is an individually administered measure of processing and reasoning abilities. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID­III DQ score is based on the cognitive domain. The DQ score for KABC­II is calculated from the average non­verbal age-equivalent score. A positive value indicates improvement in health and cognition.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||percentage of chronological age||Standard Deviation|Mean
1425887|NCT01047306|Primary|Change From Baseline in Bayley Scales of Infant Development-III/Kaufman Assessment Battery for Children-II (BSID-III/KABC-II) Age-Equivalent Scores|Children 1 year-42 months were assessed by the BSID­III; those >42 months and with a developmental age of >42 months by the Vineland Adaptive Behavior Scales­II (VABS­II) were evaluated with the KABC­II. For children >42 months, but <42 months in developmental age, and those unable to complete at least 3 cognitive KABC­II subtests, the BSID­III was used. The BSID­III is a series of measurements to assess the motor, language, and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The KABC­II is an individually administered measure of processing/reasoning abilities. Raw scores were converted to age­ equivalent scores to measure ability, skill, and knowledge, expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound ). A positive value indicates improvement. The BSID­III and KABC­II age­ equivalent scores were based on the cognitive domain and average non-verbal age-equivalent score, respectively.|Baseline, 6 months, 12 months, and End of Study (Month 24 assessment or early termination)|All analyses were based on the Main Analysis Population, which included all enrolled patients. Data were not available for all patients at all time points.|||months||Standard Deviation|Mean
1425888|NCT01047293|Primary|Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part)|Number of patients who experienced a Dose Limiting Toxicity (DLT). DLT will be assessed in the first 28 days of dosing. Patients need to get dosed with 2 rounds/sessions of all chemotherapy agents in the first 28 days in order to be evaluable for DLT assessment. The primary endpoint is safety as summarized by dose limiting toxicity (DLT).|December 2011||||participants|||Number
1425889|NCT01047293|Primary|Progression Free Survival at Six Months||6 months|Progression free survival at six month was calculated using all patients receiving one dose of drug therapy at all of the different dosing levels. The six month progression free survival was determined using Kaplan Meier methods|||percentage of participants||95% Confidence Interval|Number
1425890|NCT01047241|Primary|Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine||Time=5-60 min after administration of investigational medicinal product||||minutes||Standard Deviation|Mean
1425891|NCT01047241|Primary|Bioavailability of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product||||percentage bioavailable||Standard Error|Mean
1425892|NCT01047241|Secondary|Acceptance of Intranasal Administration|Asking the children (parents for preverbal children) if they would like to receive this treatment again in a similar situation rather than analgesic suppositories, tablets, oral solutions, or injections?|Immediately after the procedure||||percentage of participants|||Number
1425893|NCT01047241|Secondary|Sedation Score (UMSS)|"University of Michigan Sedation Score (UMSS) (0-4, 0 awake and alert, 4 unarousable)"|Time= 0-70 min. after drug administration||||units on a scale||Full Range|Median
1425894|NCT01047241|Primary|Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine||Time= 5-60 min after administration of the investigational medical product||||mcg/L||Standard Deviation|Mean
1429734|NCT01012167|Secondary|Laboratory Measures - Chloride|Chloride blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
1425895|NCT01047241|Primary|Procedural Pain Intensity Score|Children <5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 5 years but < 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).|Pain assessment during painful medical procedure||||units on a scale||Inter-Quartile Range|Median
1425896|NCT01047189|Secondary|The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count||Baseline to 12 weeks|All patients were analyzed up to end of treatment or last visit.|||percentage of lesions||95% Confidence Interval|Mean
1425897|NCT01047189|Primary|Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne|Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap|12 weeks|All patients were analyzed up to end of treatment or last visit.|||Percent of doses||Full Range|Median
1425898|NCT01047007|Secondary|MTD of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Solid Tumors|The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic solid tumors was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established.|Cycle 1 (21 days)|Participants who received at least one dose of MK-1775 in combination with 5-FU/CDDP and completed Cycle 1 of Parts 2B and 3. No participants received the 5-FU/CDDP regimen due to early termination of the study.||||||
1425899|NCT01047007|Primary|Maximum Tolerated Dose (MTD) of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Esophageal, Head and Neck, or Gastric Cancer|The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic esophageal, head and neck, or gastric cancer was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established.|Cycle 1 (21 days)|Participants who received at least one dose of MK-1775 in combination with 5-FU/CDDP and completed Cycle 1 of Parts 2B and 3. No participants received the 5-FU/CDDP regimen due to early termination of the study.||||||
1425900|NCT01047007|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity preventing treatment for ≥3 weeks or preventing administration of ≥8 of 10 doses in Parts 1 or 2A1 or 4 of 5 doses in Part 2A2.|Cycle 1 (21 days)|The DLT-evaluable population consisted of participants who received at least one dose of MK-1775 and completed Cycle 1 of Parts 1, 2A1, 2A2, or discontinued due to toxicity.|||Participants|||Number
1425901|NCT01046903|Other Pre-specified|Number of Participants With Hematoma|Hematoma is a localized collection of blood outside of a blood vessel. It includes subcutaneous hematoma and injection-site hematoma.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425902|NCT01046903|Other Pre-specified|Number of Participants Compliant With the Treatment|Compliance was defined as participants documented with Dalteparin Sodium up to 5 weeks after initiation of thromboprophylaxis.|Baseline up to Week 5|Data was collected but not statistically summarized for analysis.|||Participants|||Number
1425903|NCT01046903|Other Pre-specified|Administration Schedule of Treatment|Administration schedule for Fragmin in major orthopedic surgery Included was categorized as; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425904|NCT01046903|Primary|Physician's Assessment of Efficacy of Treatment|Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Full Analysis Set (FAS) included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425905|NCT01046903|Other Pre-specified|Physician's Assessment of Tolerability of Treatment|Tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425906|NCT01046903|Other Pre-specified|Participant's Global Evaluation of Treatment|Participant's global evaluation of treatment for overall response and comfort was evaluated on the four point categorical scale: excellent, good, fair and poor.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1440826|NCT00928720|Primary|Pain Intensity Using Numeric Rating Scale|A Numeric Rating Scale ranging from 0 (no pain) to 10 (worst pain imaginable) to capture present pain intensity|week 8||||units on a scale||Standard Deviation|Mean
1425907|NCT01046903|Other Pre-specified|Number of Participants With Bleeding|Major bleeding: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram/litre (g/L) (2 g/decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor bleeding was defined as bleeding that did not meet the definition of major bleeding.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425908|NCT01046903|Other Pre-specified|Number of Participants With Thromboembolism|Thromboembolism is the formation of blood clot in the blood vessels due to an embolus (a detached intravascular mass capable of clogging arterial capillary beds at a site far from its origin).|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425909|NCT01046903|Other Pre-specified|Number of Participants With Risk Factors|Risk factors evaluated for vascular thromboembolism (VTE) were age (above 40 years, but age was not a strong risk factor as a prediction of potential VTE episode), gender (primarily females but males after 65 years also influenced VTE episode), obesity, pregnancy, liver disease, kidney disease, hormone therapy, immobilization, previous surgery, concomitant malignant disease, positive family history, varicose veins, smoking, chemotherapy, catheter in vein, Heart Failure III New York Heart Association (NYHA) and Heart Failure IV NYHA.|Baseline|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425910|NCT01046903|Other Pre-specified|Participant's Dosage Regimen|Approved dosage regimens for Fragmin in major orthopedic surgery included; (1): first dose of Fragmin 5000 IU in the evening before the day of surgery, followed by daily doses of 5000 IU up to 5 weeks; (2): first dose of Fragmin 2500 IU 2 hours before surgery, and a second dose of 2500 IU 8 to 12 hours later, not earlier than 4 hours after surgery, followed by daily doses of 5000 IU up to 5 weeks or (3): first dose of Fragmin 2500 IU 4 to 8 hours postoperatively, followed by daily doses of 5000 IU up to 5 weeks.|Baseline up to Week 5|The Safety Analysis Set included all those participants who received at least 1 dose of the study medication.|||Participants|||Number
1425911|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|12 months post procedure|One subject was lost to follow-up following the procedure. 2 subjects were lost to follow-up after the 30 day visit. 2 subjects were lost to follow-up after the 3 month visit. 3 subjects were lost to follow-up following the 6 month visit. 4 subjects were lost to follow-up after the 9 month visit and 2 subjects missed the 12 month visit.|||percentage of ears|Participants|95% Confidence Interval|Number
1425912|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|9 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two subjects were lost to follow-up after the 3 month visit. Three additional subjects were lost to follow-up following the 6 month visit and one subject missed the 9 month visit.|||percentage of ears|Participants|95% Confidence Interval|Number
1425913|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|6 months|One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two additional subjects were lost to follow-up after the 3 month visit and two subject missed the 3 month visit.|||percentage of ears|Participants|95% Confidence Interval|Number
1425914|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|3 months|One subject was lost to follow-up immediately following the procedure. Two additional subjects were lost to follow-up after the 30 day visit and one subject missed the 30 day visit.|||percentage of ears|Participants|95% Confidence Interval|Number
1425915|NCT01046877|Secondary|Percentage of Ears With Adverse Events|This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)|30 days|One subject was lost to follow-up immediately following the procedure.|||percentage of ears|Participants|95% Confidence Interval|Number
1425916|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|9 Months|3 subjects lost to follow-up after 6 mo visit. 1 subject missed 9 mo visit. 2 subjects lost to follow-up after 3 mo visit. 2 subjects lost to follow-up after 30 day visit. 1 subject lost to follow-up following procedure. Thus, only 3 ears (= 3 participants) of 16 participants returning at 9 mos had unextruded tubes for assessment of patency.|||percentage of tubes|Participants|95% Confidence Interval|Number
1425917|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|6 months|Two subjects lost to follow-up after 3 month visit. Two subjects missed 6 month visit. Two subjects lost to follow-up after 30 day visit. One subject lost to follow-up immediately following procedure. Thus, only 13 ears (= 9 participants) of 18 participants returning at 6 months had unextruded tubes for assessment of patency.|||percentage of tubes|Participants|95% Confidence Interval|Number
1425918|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|3 months|Two subjects were lost to follow-up after the 30 day visit and one subject missed the 3 month visit. One subject was lost to follow-up immediately following the procedure. Thus, only 28 ears of 21 participants had unextruded tubes for assessment of tube patency.|||percentage of tubes|Participants|95% Confidence Interval|Number
1425919|NCT01046877|Secondary|Percentage of Patent Tubes|This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.|30 days|One subject (one ear) was lost to follow-up immediately following the procedure.|||percentage of tubes|Participants|95% Confidence Interval|Number
1425920|NCT01046877|Secondary|Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure||12 months|Over the course of 12 months, a total of 17 subjects (25 ears) were assessed at varying follow-up time points as having had tubes extruded. Ears analyzed included those for which a tube was observed to extrude at any follow-up visit and ears that completed the 12 month visit.|||percentage of tubes|Participants|95% Confidence Interval|Number
1425924|NCT01046695|Secondary|Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours|As subjects could have been prescribed many different analgesics, the amount of pain medication was converted to the standard oral morphine equivalents (OME), so that the mean dose needed could be compared.|24 hours and 48 hours after awakening from video-assisted thoracic surgery||||mg of oral morphine||Standard Deviation|Mean
1425925|NCT01046682|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery Measured by Ultrasound Over 13 Weeks|Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.|Entry and week 13 visits|Number of participants for analysis was determined by the number of participants that had 2 FMD tests performed|||% change from baseline||Inter-Quartile Range|Median
1425926|NCT01046643|Secondary|Neuropsychological Testing Scores - Visual Learning Retention|"Changes in neuropsychological testing measures (visual learning retention) with hormone use (either estradiol or progesterone) versus placebo.~Subjects are given tests that present them with a series of pictures. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the California Verbal Learning Test - 2nd edition.~The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.|||percent retention||Standard Deviation|Mean
1425927|NCT01046643|Primary|Changes in Brain Activation Patterns in Visual Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in visual tasks with hormone use (either estradiol or progesterone) versus placebo.~The test is a visual working memory task, where the women are presented with 3 geometric grids on the screen. The target grid is on top, and 2 test grids are on the bottom. The women must decide if the right or left test grid matches the grid on top. There are 3 conditions: a match condition where all 3 grids are shown simultaneously, and 2 delay conditions, where the target grid is shown first, disappears, and the test grids appear after a 1 or a 4 second delay.~The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.|||percent BOLD signal changes||Standard Deviation|Mean
1425928|NCT01046643|Secondary|Neuropsychological Testing Scores - Verbal Learning Retention|"Changes in neuropsychological testing measures (verbal learning retention) with hormone use (either estradiol or progesterone) versus placebo.~Subjects are given tests that present them with a series of words. They are asked to recall how many items they can remember, and then some time later, are asked to recall the items again. The retention measure is how many items they can remember at the later time point, compared to the earlier time point. Adapted from the Benton Visual Memory Test, Revised.~The tests were administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged.|||percent retention||Standard Deviation|Mean
1425929|NCT01046643|Primary|Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans|"Measure the changes in brain activity in verbal tasks with hormone use (either estradiol or progesterone) versus placebo.~The test is a deep and shallow verbal processing task, where the subjects are presented lists of words, one word at a time, and are asked to make one of 2 decisions about each list. One decision is whether each word is written in upper or lower case letters (shallow processing), and the other decision is whether each word denotes an abstract or concrete concept (deep processing).~The test was administered 3 months after baseline and 38 weeks after baseline."|August 2010 - March 2012|Within the Estrogen/Placebo groups, 3 participants were unable to complete the needed fMRI analyses due to adverse events, and in the Progesterone/Placebo groups, 1 participant's fMRI scans were damaged and unable to be used in the analysis.|||percent BOLD signal changes||Standard Deviation|Mean
1425930|NCT01046565|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)|||participants|||Number
1425931|NCT01046565|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 – 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol|||participants|||Number
1425932|NCT01046396|Secondary|6 Question Subject Cosmetic Acceptability Questionnaire at Week 3|Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3.|week 3|ITT (Intent to Treat)|||participants|||Number
1425933|NCT01046396|Primary|Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.|Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 – 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0.|baseline to week 3|Per protocol|||participants|||Number
1427153|NCT01033825|Secondary|Percentage of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population|||percentage of subjects|||Number
1425934|NCT01046253|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
1425935|NCT01046253|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
1425936|NCT01046253|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng/mL||Standard Deviation|Mean
1425937|NCT01046136|Primary|Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.|Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.|Baseline and Day 4||||units on a scale||Standard Deviation|Mean
1425938|NCT01046136|Secondary|Number of Patients With Adverse Events|Total number of patients with adverse events that were possibly or probably related.|7 days|All participants who received study medication, excluding participants who later returned all the dispensed study medication to the site unused.|||participants|||Number
1425939|NCT01046136|Primary|Investigator's End of Study Assessment of Treatment|Yes the investigator would use this treatment for cold symptoms in the future.|7 days|MITT defined as all participants receiving at least 1 dose of study medication and had 1 or more efficacy assessment after Baseline. Last observation carried forward method was applied to missing post baseline measurement in the analyses of the MITT population.|||participants|||Number
1425940|NCT01046110|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One site was closed, hence 11 randomised subjects (4 in IDeg and 7 in DPP-IV group/arm) were excluded from the FAS. Fasting plasma glucose values were missing for another 8 subjects, hence did not contribute to the analysis.|||mmol/L||Standard Deviation|Mean
1425941|NCT01046110|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). A site was closed, hence 11 randomised subjects (4 subjects with IDeg; 7 subjects with DPP-IV group/arm) were excluded from the FAS.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1425942|NCT01046084|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
1425943|NCT01046084|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng*h/mL||Standard Deviation|Mean
1425944|NCT01046084|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).|||ng/mL||Standard Deviation|Mean
1425945|NCT01045993|Secondary|Number of Participants Per Categorical Score for Global Assessment of Study Treatment|At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.|||participants|||Number
1425946|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425947|NCT01045993|Secondary|Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425959|NCT01045993|Secondary|Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)|TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425948|NCT01045993|Secondary|Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension|Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425949|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||degrees||Standard Deviation|Mean
1425950|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||degrees||Standard Deviation|Mean
1425951|NCT01045993|Secondary|Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension|Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||degrees||Standard Deviation|Mean
1425952|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation|Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425953|NCT01045993|Secondary|Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side|Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425954|NCT01045993|Secondary|Change From Baseline (Bsl) in Combined Flexibility Score: Extension|Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement.|Baseline (time of wrap application or oral treatment administration) and 4 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425955|NCT01045993|Secondary|Change From Baseline in Individual Time-point Back Stiffness Scores|Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness).|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.|||scores on a scale||Standard Deviation|Mean
1425956|NCT01045993|Secondary|Individual Time-Point Pain Relief Scores|Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief.|At 60, 120, 180, 240, 300, 360, 420, and 480 minutes|ITT population.|||scores on a scale||Standard Deviation|Mean
1425957|NCT01045993|Secondary|Time to Treatment Failure|Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study).|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population. Time to treatment failure not calculable as there were no treatment failures in this study. No participants required use of rescue medication or discontinued study prior to 8 hour evaluation.||||||
1425958|NCT01045993|Secondary|Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours|Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement.|Baseline (time of wrap application or oral treatment administration) up to 8 hours|ITT population.|||scores on a scale||Standard Deviation|Mean
1425960|NCT01045993|Primary|Time to First Perceptible Relief (Confirmed by Meaningful Relief)|"“First perceptible relief” defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled “first perceptible relief” (any pain relieving effect), provided the participant also depressed the second stopwatch labeled meaningful relief” (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee."|Baseline (time of wrap application or oral treatment administration) up to 4 hours|Intent-to-treat population (ITT): all randomized participants who applied/dosed with study product and had a baseline assessment. Median and/or upper limit of CI reported as 240 minutes if >240 minutes. No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.|||minutes||95% Confidence Interval|Median
1425961|NCT01045993|Secondary|Time to Meaningful Relief|Time to “meaningful relief” defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating “meaningful relief” (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee.|Baseline (time of wrap application or oral treatment administration) up to 4 hours|ITT population. Median and/or upper limit of CI reported as 240 minutes if median or upper limit >240 minutes.|||minutes||95% Confidence Interval|Median
1425962|NCT01045967|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1425963|NCT01045967|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1425964|NCT01045967|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1425965|NCT01045798|Primary|The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study.|"The feasibility of conducting a major randomized study of caspofungin for empirical therapy for invasive candidiasis in high-risk non-neutropenic intensive care unit (ICU) participants was to be assessed by the incidence of study therapy discontinuations due to investigators choosing to treat participants with empirical antifungal therapy outside of the context of this protocol.~Study drug was administered for a minimum of 7 days to a maximum of 14 days provided participants had no evidence of confirmed breakthrough invasive Candida infection while receiving study drug."|1 to 14 days|Of the 114 participants anticipated to enroll in this study, 15 actually enrolled and only 14 received study drug. The participant who did not receive study drug was discontinued; the remaining 14 received at least one dose of study drug, met inclusion/exclusion criteria, and therefore qualified for the full analysis set used for summary analyses.|||Participants|||Number
1425966|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1425967|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1425968|NCT01045707|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1425969|NCT01045707|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed. For 24 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1426024|NCT01044862|Secondary|Time to Pregnancy||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||days||Standard Deviation|Mean
1456130|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|up to 44 weeks||||inches||Standard Deviation|Mean
1425970|NCT01045707|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1425971|NCT01045707|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1425972|NCT01045694|Secondary|Strength||twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.||||||
1425973|NCT01045694|Secondary|Range of Motion||twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.||||||
1425974|NCT01045694|Primary|Pain||twenty-four hours, ten days, twelve weeks, six months, and one year|8 participants were randomized; 2 withdrew voluntarily. Study was terminated due to lack of funds, and unblinding did not occur - it is not known how many participants were placed in each group. Data was not collected or analyzed.||||||
1425975|NCT01045551|Secondary|Change From Visit 8 (Week 12) in Telangiectasia Count at Visit 9 (Week 16)||Week 12, Week 16||||telangiectasia count||Standard Error|Mean
1425976|NCT01045551|Secondary|Change From Baseline in Telangiectasia Count at Visit 8 (Week 12)|physician count of telangiectasias on the face at visit 1 (baseline) compared to at visit 8 (week 12)|Baseline, Week 12||||telangiectasia count||Standard Error|Mean
1425977|NCT01045551|Secondary|Change From Baseline in Erythema Rating Visit 8 (Week 12)|The change in the Physician Overall Erythema Severity. Scale range 0 - 3. 0 = none/absent, 1 = mild, 2 = moderate, 3 = severe. 0 is considered a better outcome, 3 is considered a worse outcome.|Baseline, Week 12||||units on a scale||Standard Deviation|Mean
1425978|NCT01045551|Secondary|Change in Physician 7 Point Global Assessment From Baseline to Week 12|The Physician Global 7-point Assessment. Scale range: 0-7. 0 = clear, 1 = minimal, 2 = mild, 3 = mild to moderate, 4= moderate, 5= moderate to severe, 6 = severe. 0 is a better outcome, 6 is a worse outcome. No subscales were used.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
1425979|NCT01045551|Primary|Change From Baseline in the Total Number of Papulopustular Lesions at Week 12|Papule and pustule count consisted of direct measurement of the number of papules/pustules on the face. Papule and pustule count, compared between baseline and end of treatment Week 12 was calculated|Baseline to Week 12||||papule count||Standard Deviation|Mean
1425980|NCT01045447|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS. For 23 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1425981|NCT01045447|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Two subjects withdrew prior to exposure to trial drug, hence excluded from the FAS.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1425982|NCT01045421|Secondary|Phase 2: Relationship Between Clinical Response and Molecular Markers of Response|In SCLC,chemo-sensitive/resistant population were analyzed;in breast cancers,ER2 and ER2 status were analyzed.HR+ =estrogen receptor-positive or progesterone receptor-positive. HER+ =human epidermal growth factor receptor 2 (HER2). Triple negative =negative for estrogen receptors, progesterone receptors, and HER2.Clinical response according to RECIST version 1.1. CR:complete disappearance of all target lesions,non-target disease,except nodal disease;all nodes decrease to normal (short axis <10 mm);no new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions (SLD);short axis was used in the sum for target nodes,longest diameter used in the sum for all other target lesions;no unequivocal progression of non-target disease;no new lesions. Progressive Disease (PD): >=20% rise in SLD from the smallest value on study;unequivocal progression of existing non-target lesions. Stable Disease (SD):Neither sufficient shrinkage for PR nor sufficient increase for PD.|12 months|Response-Evaluable population. Data is reported only for SCLC and breast cancer cohorts becuase these cohorts showed clinical meaningful single agent activity, thus subgroup analysis were done to assess whether a particular subgroup of participants was more or less responsive to alisertib. Rest of the cohorts did not show meaningful activity.|||percentage of participants||95% Confidence Interval|Number
1425983|NCT01045421|Secondary|Phase 1: Steady State Oral Clearance (CLss/F) for Alisertib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-tau), expressed in liter per hour (L/hr).|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1425984|NCT01045421|Secondary|Phase 1: Peak to Trough Ratio for Alisertib|Peak to trough ratio was estimated as a ratio of Cmax at Day 7 and the minimum observed plasma concentration (Ctrough) of alisertib at Day 7. Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Ctrough is the minimum plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||ratio||Standard Deviation|Mean
1425985|NCT01045421|Secondary|Phase 1: Rac- Accumulation Ratio for Alisertib|Rac was estimated as a ratio of AUC (0-tau) at Day 7 and AUC (0-tau) at Day 1. Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||ratio||Standard Deviation|Mean
1425986|NCT01045421|Secondary|Phase 1: Terminal Phase Elimination Half-life (T1/2) for Alisertib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 7 assessment was available.|||hours||Standard Deviation|Mean
1425987|NCT01045421|Secondary|Phase 1: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||nanomole*hour (nM*hr)||Geometric Coefficient of Variation|Geometric Mean
1425988|NCT01045421|Secondary|Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose|PK-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Day 1 and Day 7 assessment were available.|||hours||Full Range|Median
1425989|NCT01045421|Secondary|Phase 1: Cmax- Maximum Observed Plasma Concentration for Alisertib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours post-dose|Pharmacokinetic (PK)-Evaluable population included all participants who had sufficient dosing data and alisertib concentration-time data to permit calculation of alisertib PK parameters in Phase 1 where Days 1 and 7 assessment were available.|||nanomole (nM)||Geometric Coefficient of Variation|Geometric Mean
1425990|NCT01045421|Secondary|Phase 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after the last dose of study drug|Safety population included all participants who received any amount of alisertib.|||participants|||Number
1425991|NCT01045421|Secondary|Phase 2: Duration of Response (DOR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response=(the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). CR: complete disappearance of all target lesions and non-target disease, except nodal disease; all nodes decreased to normal; no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. Tumor progression: >=20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); absolute increase of >=5 mm; appearance of >=1 new lesions is also considered progression. DOR calculated for the subgroup of participants with objective response.|Baseline up to Week 50|Included a subset of response-evaluable population who had objective tumor response.|||days||95% Confidence Interval|Median
1425992|NCT01045421|Secondary|Phase 2: Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until disease progression, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.|||days||95% Confidence Interval|Median
1425993|NCT01045421|Secondary|Phase 2: Progression-free Survival (PFS)|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.|Baseline until progressive disease, assessed every 2 cycles up to end of study (up to 50 cycles)|Safety population included all participants who received any amount of alisertib.|||days||95% Confidence Interval|Median
1426025|NCT01044862|Secondary|Rate of Pregnancy Obtained||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||participants|||Number
1426026|NCT01044862|Primary|Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH.||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||number of multiples|||Number
1425994|NCT01045421|Primary|Phase 2: Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until complete response or partial response, assessed every 2 cycles up to end of study (up to 50 cycles)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1425995|NCT01045421|Primary|Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)|Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/cubic meter [cells/mm^3]) for >7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets <25,000 cells/mm3) for >7 days; Platelet count <10,000 cells/mm3; Grade 3 thrombocytopenia with clinically significant bleeding; Delay in initiation of the subsequent therapy cycle by >7 days due to treatment-related toxicity; >=Grade 3 nonhematological toxicity except >=Grade 3 nausea/emesis occurred in the absence of optimal antiemetic therapy; >=Grade 3 diarrhea occurred in the absence of optimal supportive therapy with loperamide/comparable antidiarrheal; Grade 3 fatigue for <1 week; Other Grade 3 nonhematological toxicity that could be safely, reliably controlled to <=Grade 2 with appropriate treatment.|Phase 1: Cycle 1 Day 1 to Cycle 2 Day 21|DLT-Evaluable population: all participants in the Phase 1 portion of the study who either experienced DLT during Cycle 1 or completed at least 85% of the planned doses of alisertib and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.|||participants|||Number
1425996|NCT01045265|Secondary|Semen to Plasma Distribution of Raltegravir|Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.|6 months||||ratio||Inter-Quartile Range|Median
1425997|NCT01045265|Secondary|Seminal Distribution of Raltegravir|Determine the area under the concentration time curve of raltegravir in semen.|6 months||||h mg/l||Inter-Quartile Range|Median
1425998|NCT01045265|Secondary|Semen to Plasma Raltegravir Concentrations|Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.|6 months||||ratio||Inter-Quartile Range|Median
1425999|NCT01045265|Primary|Seminal Concentrations of Raltegravir.|Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.|6 months||||mg/l||Inter-Quartile Range|Median
1426000|NCT01045187|Secondary|Assess Occurence Rate of Toxicities||through 3 month follow up post treatment|||||||
1426001|NCT01045187|Secondary|Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice||through 3 month post treatment|||||||
1426002|NCT01045187|Primary|Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System||through completion of radiation therapy||||Participants|||Number
1426003|NCT01045161|Secondary|Part B: Peak FEV1|Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.|||L||Standard Error|Least Squares Mean
1426004|NCT01045161|Primary|Part B: Morning Predose (Trough) FEV1|Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)|Change from baseline (Week 0) to 52 Weeks|A total of 544 patients were randomized, with 542 in the Part A Safety population. Of the 454 patients who completed Part A, 448 patients continued into Part B, receiving at least 1 dose of open-label treatment, were included in the Part B Safety Population. Of these patients, 405 had a baseline and postbaseline assessment for the ITT Population.|||L||Standard Deviation|Mean
1426005|NCT01045161|Secondary|Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.|||L||Standard Error|Least Squares Mean
1426006|NCT01045161|Primary|Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from baseline (Week 0) to Week 12|Of 544 patients randomized, 542 patients received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these patients, 541 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.|||L||Standard Error|Least Squares Mean
1426007|NCT01045122|Primary|Respiratory Disturbance Index|respiratory events (apneas, hypopneas) per hour|during infusion of study drugs|Per protocol|||events per hour||Standard Deviation|Mean
1426008|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL||Standard Deviation|Mean
1426009|NCT01045096|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL||Standard Deviation|Mean
1426010|NCT01045096|Primary|The Peak Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng/mL||Standard Deviation|Mean
1426011|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)|AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL/mg||Standard Deviation|Mean
1426012|NCT01045096|Other Pre-specified|Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng*hr/mL/mg||Standard Deviation|Mean
1426013|NCT01045096|Other Pre-specified|Dose-normalized Peak Plasma Concentration (Cmax/Dose)|Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||ng/mL/mg||Standard Deviation|Mean
1426014|NCT01045096|Primary|Time to Reach the Peak Plasma Concentration (Tmax)|Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.|Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.|Pharmacokinetic (PK) set included all participants with at least one estimable PK parameter for dexlansoprazole on Day 7.|||hours||Standard Deviation|Mean
1426015|NCT01045057|Secondary|Postoperative Results|Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.|1 month|Only patients with secondary puncture filled out questionnaire. Seven patients had secondary puncture. One patient refused to fill out questionnaire. Six patients remained. Analysis per protocol.|||Number of patients|||Number
1426016|NCT01045057|Secondary|Cost Effectiveness Calculation|"cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set.~Measurements are: time needed to perform procedure"|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.|||seconds||Standard Deviation|Mean
1426017|NCT01045057|Secondary|Satisfaction of Physician|Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used.|1 month|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.|||Number of times new set was preferred|||Number
1426018|NCT01045057|Primary|Success Rate of Procedure|As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.|immediate observation during surgery|Number subjects based on optimal minimax two-stage design. Based on power calculation, 26 patients should be included. In first stage, 20/23 successful insertions are needed to continue. In second stage, with 23/26 successful insertions device is considered safe. Analysis is per protocol.|||Nr part. with succesful insertions|||Number
1426019|NCT01045031|Secondary|Insulin-like Growth Factor (IGF-1)||Baseline and 5 years||||ng/mL||Standard Deviation|Mean
1426020|NCT01045031|Secondary|Self Rating by Questionnaires|The following self rating scales were used: WHO-5 Quality of Life Assessment (Braeher, E., Muehlan, H., Albani, C., & Schmidt, S. (2007). Testing and standardization of the German version of the EUROHIS-QOL and WHO-5 quality-of life-indices. Diagnostica, 53(2), 83-96.). Range: 0 - 25, higher scores indicate better quality of life.|Baseline and 5 years|Study population (Baseline and follow-up)|||point scale||Standard Deviation|Mean
1426021|NCT01045031|Primary|Brain-derived Neurotrophic Factor (BDNF)||Baseline and 5 years|Baseline values differ from published data, since BDNF-levels had to be re-assessed from banked material due to a manufacturer-based change of the analysis kit.|||ng/mL||Standard Deviation|Mean
1426022|NCT01045031|Primary|the Proportion of Subjects, Who Will Develop Mild Cognitive Impairment|Hypothesis will be tested at the second follow-up examinations.|10 years||2019-12-31|12/2019||||
1426023|NCT01044862|Secondary|Live Birth Rate||Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks||||participants|||Number
1426027|NCT01044771|Secondary|Patients Without HIV Re-bound|HIV Viral load blood test at week 24|24 weeks|Subjects entered with undetectable Viral Load and Proteinuria|||participants|||Number
1426029|NCT01044758|Secondary|Behavioral Performance as Assessed in the Functional Magnetic Resonance Imaging (fMRI) Memory Task|Mnemonic similarity task which assesses long term memory function. Scale ranges from 0-100 with higher scores indicating better memory performance.|2 weeks||||percent correct recalled||Standard Error|Mean
1426030|NCT01044758|Primary|Brain Activity in the Dentate Gyrus / CA3 Subregion of the Hippocampus Measured With Blood Oxygenation Level Dependent (BOLD) Functional MRI|Measurement of average brain activity in the dentate gyrus / CA3 subregion of the hippocampus measured with BOLD functional MRI in patients with mild cognitive impairment on placebo and on drug compared to average brain activity in this brain area in control subjects.|2 weeks||||mean beta coefficient||Standard Error|Mean
1426031|NCT01044732|Secondary|Times for Withdrawal Phase and for Complete Procedure|For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|All subjects in study (i.e., Group A and Group B combined)|||Minutes||Standard Deviation|Mean
1426032|NCT01044732|Primary|Detection Rates for Adenomas and for Total Polyps|Numbers of polyps and adenomas detected in first and second procedures for each group|Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.|Per-protocol population|||Polyps or adenomas detected|||Number
1426033|NCT01044706|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|maximum observed concentration of drug substance in plasma|144 hour||||ng/mL||Standard Deviation|Geometric Mean
1426034|NCT01044706|Primary|AUC0-144 (Area Under the Concentration-time Curve From Time Zero to 144 Hour Post-dose)|AUC0-144 (area under the concentration-time curve from time zero to 144 hour post-dose)|144 hour|per protocol|||ng*h/mL||Standard Deviation|Geometric Mean
1426035|NCT01044693|Secondary|Change in Heart Rate During the Night|Change from baseline (8 pm) in heart rate at the time of maximal BP-lowering effect|8 pm - 8 am|Participants who completed the 4 treatment arms|||bpm||Standard Error|Mean
1426036|NCT01044693|Secondary|Orthostatic Tolerance the Following Morning|Orthostatic tolerance was defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test|10 min standing|Comparisons were made only for patients who could stand after all treatment groups|||mm Hg*min||Standard Error|Mean
1426037|NCT01044693|Secondary|Nocturnal Urinary Sodium Excretion|Nocturnal sodium excretion was defined as the ratio of urinary sodium to urinary creatinine.|8 pm - 8 am|Participants with complete urine collections during the 4 study nights|||mEq/mg||Standard Error|Mean
1426038|NCT01044693|Primary|Change in Systolic Blood Pressure During the Night|Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention|8 pm - 8 am|Participants who completed the 4 treatment arms|||mm Hg||Standard Error|Mean
1426039|NCT01044589|Secondary|Number of Participants Reporting a Decrease in Incontinence Episodes Per Week||24 months||||Participants|||Count of Participants
1426040|NCT01044589|Primary|Number of Participants Reporting a Decrease in Incontinence Episodes Per Week||12 months||||Participants|||Count of Participants
1426041|NCT01044537|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration versus time curve from time zero to extrapolated infinite time.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1426042|NCT01044537|Secondary|Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of area under the plasma insulin concentration-time curve from time 2 to 6 hrs (in terms of milliunit*deciliter*hour [mU*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*liter*hour [mg*liter*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. ‘N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm group, respectively.|||(mU*dL*hour)/(mg*liter*hour)||Standard Deviation|Mean
1426043|NCT01044537|Secondary|Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT)|Ratio of C-peptide Delta C30 (in terms of nanogram*deciliter [ng*dL]) to glucose delta C30 (in terms of milligram*milliliter [mg*mL]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||(ng*dL)/(mg*mL)||Standard Deviation|Mean
1426044|NCT01044537|Secondary|Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of insulin delta C30 (in terms of milliunits*deciliter [mU*dL]) to glucose delta C30 (in terms of milligram*liter [mg*liter]) was calculated. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.5 hrs pre-dose on Day -1; 2, 2.5 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||(mU*dL)/(mg*Liter)||Standard Deviation|Mean
1426056|NCT01044498|Secondary|Serum C-reactive Protein (CRP) Level|Blood samples were collected pre-dose of tocilizumab infusion on Day 1 of Cycle 2 and on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and on Days 1, 7, and 21 of Cycle 3. Serum levels of C-reactive protein were measured by the Tina-quant CRP (latex) high-sensitivity Roche Immunoturbidimetric method.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||mg/L||Standard Deviation|Mean
1426045|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here ‘N’ (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1426046|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1426047|NCT01044537|Secondary|Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Percent change from baseline in post-prandial area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent change||Standard Deviation|Mean
1426048|NCT01044537|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||hour||Standard Deviation|Mean
1426049|NCT01044537|Primary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
1426050|NCT01044537|Primary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest. Here ‘N' (number of participants analyzed) signifies participants evaluable for this measure.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1426051|NCT01044537|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
1426052|NCT01044537|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|PK parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1426053|NCT01044537|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled participants who received study medication and had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1426054|NCT01044537|Secondary|Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1|Ratio of area under the plasma C-peptide concentration-time curve from time 2 to 6 hrs (in terms of nanogram*deciliter*hour [ng*dL*hour]) to area under the plasma glucose concentration-time curve from time 2 to 6 hrs (in terms of milligram*milliliter*hour [mg*mL*hour]) was calculated. Linear trapezoidal method was used to compute AUC. The change in ratio from baseline (Day -1) was calculated at Day 1.|-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hours pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hours post-dose on Day 1|PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 of the PD parameters of interest. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable at specified time point for each arm group, respectively.|||(ng*dL*hour)/(mg*mL*hour)||Standard Deviation|Mean
1426055|NCT01044537|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to 10 days after last dose of study medication (up to 11 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
1426057|NCT01044498|Secondary|Serum Soluble Interleukin-6 Receptor (sIL-6R) Level|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. Serum levels of soluble interleukin-6 receptor were analyzed using a validated ELISA.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||ng/mL||Standard Deviation|Mean
1426058|NCT01044498|Secondary|Apparent Volume of Distribution (Vz) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The apparent volume of distribution (Vz), computed as CL/Kel where CL is clearance and Kel is the apparent elimination rate, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||L||Standard Deviation|Mean
1426059|NCT01044498|Secondary|Clearance (CL) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. Clearance (CL), computed as dose/AUCinf, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||mL/hr||Standard Deviation|Mean
1426060|NCT01044498|Secondary|Terminal Half-life (t½) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The terminal half-life (t½) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
1426061|NCT01044498|Secondary|Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The area under the serum concentration-time curve from 0 to infinity (AUCinf) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above). AUCinf was computed using the linear trapezoidal rule to tlast plus Clast/Kel, where tlast is the time of the last measurable concentration, Clast is the last measurable concentration, and Kel is the apparent elimination rate, computed as the magnitude of the slope from the log-linear regression of the apparent terminal elimination phase of the serum concentration-versus-time curve.|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||µg•hr/mL||Standard Deviation|Mean
1426062|NCT01044498|Secondary|Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The time to reach maximum serum concentration was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
1426063|NCT01044498|Secondary|Maximum Observed Serum Concentration (Cmax) of Tocilizumab|Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated enzyme-linked immunosorbent assay (ELISA). The maximum observed plasma concentration (Cmax) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||µg/mL||Standard Deviation|Mean
1426064|NCT01044498|Secondary|Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The apparent oral clearance (CL/F) was derived from the plasma concentrations using a non-compartmental method and computed as dose/AUC0-24 with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||mL/hr||Standard Deviation|Mean
1426065|NCT01044498|Secondary|Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The terminal half-life (t½) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
1426066|NCT01044498|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||pg•hr/mL||Standard Deviation|Mean
1426067|NCT01044498|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The time to reach the maximum plasma concentration (Tmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading.|||hr||Standard Deviation|Mean
1426068|NCT01044498|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone|Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The maximum observed plasma concentration (Cmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).|Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.|||pg/mL||Standard Deviation|Mean
1426069|NCT01044498|Primary|Serum Progesterone Level|Blood samples were collected prior to the administration of Ortho-Novum® 1/35 on Day 21 of each cycle. Serum levels of progesterone were quantitatively determined using the ADVIA Centaur and ADVIA Centaur XP systems (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). The assay was a competitive immunoassay using direct chemiluminescent technology.|Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2|Pharmacokinetic (PK) and pharmacodynamic (PD) population: All patients enrolled in the study who had at least 1 evaluable PK or PD sample reading. Blood samples were not available for all patients at all time points.|||ng/mL||Standard Deviation|Mean
1426070|NCT01044459|Secondary|Change From Baseline in Peak FEV1|Change From Baseline in Peak FEV1 in liters at Week 52.|52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.|||L||Standard Error|Least Squares Mean
1426071|NCT01044459|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.|From baseline to 52 weeks|Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study.|||L||Standard Error|Least Squares Mean
1426072|NCT01044303|Secondary|To Assess the Rate of Rejection, Infection and Renal Function as Mycophenolic Acid Dose is Increased.||24 months||||participants|||Number
1426073|NCT01044303|Primary|Percent Change in Mean Fluorescence Index (MFI) of Donor Specific Antibodies (DSA) With Increasing Doses of Enteric-Coated Mycophenolate Sodium (EC-MPS)||24 months|This was a pilot study to examine the effect of MPA escalation on DSA reduction.|||percent of MFI change||Standard Deviation|Mean
1426074|NCT01044290|Secondary|FACT-G - Social Sub-scale|"Functional assessment of Cancer Therapy-General) is a 27 item survey which assesses physical, social/family, emotional, and functional well being. This sub-scale assesses social well-being. We omitted an item assessing satisfaction with sex life, due to high missing data. Items are rated on a 5 point likert scale, with 0 indicating not at all and 4 indicating, very much in response to item questions. Total sub-scale range is 0 to 30, with higher scores indicating better well-being."|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (64, 57, 64)||||units on a scale||Standard Deviation|Mean
1426075|NCT01044290|Primary|QUAL-E Life Completion Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 7-item life completion sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 7 and maximum was 35 with higher scores indicating greater completion.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64)||||units on a scale||Standard Deviation|Mean
1426076|NCT01044290|Secondary|FACIT-SP|The Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (Facit-SP) is a 12-item measure of faith, meaning and purpose, with a range of 0 to 48. Higher scores indicate greater spiritual well-being.|Baseline (n=75, 74, 72), 5 weeks (61, 59, 60) and 7 weeks (64, 56, 63)||||units on a scale||Standard Deviation|Mean
1426077|NCT01044290|Secondary|CES-D|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 61) and 7 weeks (n=64, 57, 64)||||units on a scale||Standard Deviation|Mean
1426111|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|6 months||||percentage of donor cells||Standard Deviation|Mean
1426078|NCT01044290|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 0-20. Higher scores indicate greater anxiety.|Baseline (n=75, 74, 72), 5 weeks (n=61, 60, 60), 7 weeks (n=64, 57, 64)||||units on a scale||Standard Deviation|Mean
1426079|NCT01044290|Primary|QUAL-E - Preparation Sub-scale|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. We include the 4-item preparation sub-scale as a primary outcomes measure. Individual items used a 5 point likert scale. The sub-scale minimum score was 5 and maximum was 20 with higher numbers indicating higher preparation.|Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)||||units on a scale||Standard Deviation|Mean
1426080|NCT01044264|Primary|Reduction of Inflammatory Lesions|The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).|Baseline and week 11|per-protocol population|||percentage reduction of lesions|||Number
1426081|NCT01044212|Secondary|Consistency of First Postoperative Bowel Movement|"The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.~The seven types of stool are:~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid"|Within 1 week of surgery||||Bristol Stool Scale||Standard Deviation|Mean
1426082|NCT01044212|Secondary|Pain Level Associated With First Postoperative Bowel Movement|The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.|Within 1 week of surgery||||VAS pain score||Standard Deviation|Mean
1426083|NCT01044212|Primary|Time to First Post-op Bowel Movement|The time to first post-operative bowel movement was measured in hours after surgery.|Within 1 week of surgery|Power analysis|||hours||Standard Deviation|Mean
1426084|NCT01044056|Primary|AUC 0-infinity (PK Parameter) for the ASPE Group.|AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.|21 days of active treatment and the washout period thereafter||||ng.h/mL||Standard Deviation|Mean
1426085|NCT01044056|Primary|AUC 0-tlast (PK Parameter) for the ASPE Group.|AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication.|||ng.h/mL||Standard Deviation|Mean
1426086|NCT01044056|Primary|Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group|AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment|21 days|Subjects who received at least one dose of medication.|||nh.h/mL||Standard Deviation|Mean
1426087|NCT01044056|Primary|Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group|Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.|21 days of active treatment and washout period thereafter|Subjects who received at least one dose of medication|||pg/ml||Standard Deviation|Mean
1426088|NCT01044030|Secondary|Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo.|Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment|12 weeks||||Participants|||Count of Participants
1426089|NCT01044030|Secondary|Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo.|Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment|12 weeks||||Participants|||Count of Participants
1426090|NCT01044030|Secondary|Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae|Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites|12 weeks|This outcome measure is limited to those subjects enrolled in the local enrolling sites only.|||percentage of participants|||Number
1426091|NCT01044030|Secondary|Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media|Proportion of subjects with no antibiotic use during the study period|12 weeks||||percentage of participants|||Number
1426092|NCT01044030|Primary|Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media|Proportion of subjects who remained free of acute otitis media throughout the study period|12 weeks||||percentage of particpants|||Number
1426093|NCT01043939|Secondary|Change in High Sensitivity C-Reactive Protein (Hs-CRP)|Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation|4 weeks||||mg/L||95% Confidence Interval|Geometric Mean
1426094|NCT01043939|Secondary|Change in Myeloperoxidase (MPO)|Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress|4 weeks||||ng/mL||95% Confidence Interval|Geometric Mean
1426095|NCT01043939|Secondary|Change in Oxidized LDL|Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress|4 weeks||||Units/Liter||Standard Error|Least Squares Mean
1426112|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|Day 100||||percentage of donor cells||Standard Deviation|Mean
1426096|NCT01043939|Primary|Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)|"Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function.~Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during & after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function."|4 weeks (change since baseline)|Intent-to-Treat analysis|||units on a scale||Standard Error|Least Squares Mean
1426097|NCT01043926|Secondary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
1426098|NCT01043926|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|From administration of study drug through 14 days after administration of study drug|All Treated Participants|||participants|||Number
1426099|NCT01043926|Primary|AUC(0-∞) After Single Dose Suvorexant: Mild Hepatic Insufficiency Participants Versus Healthy Participants (Part II)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|Per protocol, the decision to perform AUC(0-∞) analysis in mild hepatic insufficiency participants was conditional on results of AUC(0-∞) analysis in moderate hepatic insufficiency participants. Since the primary hypothesis in moderate hepatic insufficiency participants was met, AUC(0-∞) analysis in mild hepatic insufficiency was not done.||||||
1426100|NCT01043926|Secondary|Maximum Plasma Concentration (Cmax) of Suvorexant After Single Dose: Moderate Hepatic Insufficiency Participants Versus Healthy Participants|Cmax was defined as the maximum observed concentration of a drug after administration.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants|||μM||95% Confidence Interval|Geometric Mean
1426101|NCT01043926|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I)|Overall exposure was assessed by the area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞]). AUC(0-∞) was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC[0-last]) and Ct/λ, where Ct was the last measurable concentration and λ was the apparent terminal rate constant.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose|All Treated Participants|||μM•hr||95% Confidence Interval|Geometric Mean
1426102|NCT01043874|Secondary|Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set|||% participants w/ durable MMR at 24 mos||95% Confidence Interval|Number
1426103|NCT01043874|Secondary|Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|month 24|Full Analysis Set|||months||Standard Deviation|Mean
1426104|NCT01043874|Secondary|MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|24 months after treatment|Full Analysis Set|||% participants achieving MMR||95% Confidence Interval|Number
1426105|NCT01043874|Primary|MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later.|MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value|12 months after treatment|Full Analysis Set|||% participants achieving MMR||95% Confidence Interval|Number
1426106|NCT01043705|Primary|CIED Mechanical Complication|All mechanical Complications related to CIED Implant|12 months|"TYRX implants vs. published comparator are prospective arm patients. Non-TYRX CIED retrospective arm vs. TYRX CIED replacements are nested, case-control cohort."|||percentage of Participants||95% Confidence Interval|Number
1426107|NCT01043705|Primary|Major CIED Infection|CIED Major Infections|12 months|Evaluable patients that have valid entry criteria|||percentage of Participants||95% Confidence Interval|Number
1426108|NCT01043653|Secondary|Maryland Assessment of Recovery in Serious Mental Illness|The Maryland Assessment of Recovery in Serious Mental Illness is a self-report measure of recovery in people with serious mental illness. A total score was calculated by summing item responses (range=25 to 125), with higher total scores indicating greater self-reported recovery.|~ 1-year||||units on a scale||Standard Deviation|Mean
1426109|NCT01043653|Primary|Positive and Negative Symptom Scale (PANSS)|The PANSS is a clinician-rated measure of the presence and severity of symptoms of psychosis. A total score was calculated by averaging the responses on the items (range=1 to 7) scores, with higher scores indicating greater severity of psychiatric symptoms.|~1-year|The PANSS had additional missing data from 3 participants|||units on a scale||Standard Deviation|Mean
1426110|NCT01043640|Secondary|Donor Cell Chimerism Following Transplant|Donor cell chimerism is defined as the percentage of bone marrow and blood cells in the recipient that are of donor origin.|One year||||percentage of donor cells||Standard Deviation|Mean
1456131|NCT00807560|Secondary|Waist Measurement|Waist measurement in inches. This is not a primary outcome variable.|baseline||||inches||Standard Deviation|Mean
1426116|NCT01043640|Secondary|Number of Patients With Grade 4 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
1426117|NCT01043640|Secondary|Number of Patients With Grade 3 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
1426118|NCT01043640|Secondary|Number of Patients With Grade 2 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
1426119|NCT01043640|Secondary|Number of Patients With Grade 1 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
1426120|NCT01043640|Secondary|Number of Patients With Grade 0 Graft-Versus-Host Disease (GVHD)|"GVHD grading is performed using modified Glucksberg criteria and is as follows:~grade 0: absence of any skin, liver and/or gastrointestinal (GI) involvement grade 1: skin stage 1 or 2 only grade 2: skin stage 3 or liver stage 1 or lower GI stage 1 or upper GI involvement grade 3: skin stage 0 - 3 plus liver stage 2-4 or lower GI stage 2-3 grade 4: skin stage 4 or lower GI stage 4"|Day 100 Post Transplant||||Participants|||Count of Participants
1426121|NCT01043640|Primary|Number of Patients With Donor Derived Engraftment|Donor derived engraftment is defined as 80 percent or greater donor cells in the recipient's bone marrow and blood cells.|Day 100 Post Transplant||||Participants|||Count of Participants
1426122|NCT01043562|Secondary|Intrinsic Heart Rate in the Immediate Post-defibrillation Period|A patient will be considered to have an intrinsic slow heart rate in the period of time immediately following defibrillation (20 seconds) if any of the following are observed: >7 paced beats, asystole >4 seconds, or experienced >10% decrease in systolic blood pressure.|During clinical ICD procedure, as a single event|Post-defibrillation episodes in which intrinsic rhythm was evaluable and pacing was necessary|||episodes|Post-defibrillation episodes||Number
1426123|NCT01043562|Secondary|Do DFTs Vary by Type of ICD Systems Implanted?|The defibrillation threshold (as measured in Joules as already described in the details regarding the primary outcome) will be compared between patients with two distinct general types of implanted defibrillator systems: 1) transvenous ICD systems (defibrillator leads located inside the vein and attached to the endocardial surface of the heart) and 2) non-transvenous ICD systems (including all other types of debrillation systems).|During clinical ICD procedure, as a single event||||Joules||Inter-Quartile Range|Median
1426124|NCT01043562|Primary|Defibrillation Threshold|The defibrillation threshold is a measure of the minimum amount of energy (in Joules) that is able to successfully defibrillate an episode of ventricular fibrillation. This measurement is specific to each individual patient with his/her specific defibrillator configuration. There are several different strategies to measuring this in an individual patient; this study utilized the binary search protocol.|During clinical ICD procedure, as a single event||||Joules||Inter-Quartile Range|Median
1426125|NCT01043523|Other Pre-specified|Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426126|NCT01043523|Other Pre-specified|Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426127|NCT01043523|Other Pre-specified|Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426128|NCT01043523|Other Pre-specified|Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426129|NCT01043523|Other Pre-specified|Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426155|NCT01043133|Primary|Number of Participants Using Evidence-based Template to Document Asthma Care Within an Electronic Medical Record|The primary outcome measure is a count of whether or not the research participant uses the electronic health record-based Asthma AIM form to document a simulated outpatient mild persistent asthma encounter at T1 (immediately following intervention) and T2 (upon completion of family medicine clerkship approximately 35 days later).|immediately after invervention and 30+ days in follow-up||||participants|||Number
1426130|NCT01043523|Secondary|Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.|Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease.|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Percentage points|||Number
1426131|NCT01043523|Secondary|Final Diagnosis (SoT) by Clinical Investigator||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426132|NCT01043523|Secondary|The Overall Image Quality for the Postcontrast Image Only||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426133|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management / Therapy – Comparison of Precontrast Versus Combined Precontrast/Postcontrast Images (Only Subjects for Whom a Change Was Documented)||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|45 subjects had a change from additional imaging with contrast-enhanced MRI based on the precontrast images to definitive therapy.|||Participants|||Number
1426134|NCT01043523|Secondary|Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426135|NCT01043523|Secondary|Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of malignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426136|NCT01043523|Secondary|Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images|Change in number of nonmalignant lesions was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426137|NCT01043523|Secondary|Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426138|NCT01043523|Secondary|Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images||When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Participants|||Number
1426139|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast|||mmHg||Standard Deviation|Mean
1426140|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast|||mmHg||Standard Deviation|Mean
1426141|NCT01043523|Primary|Vital Signs: Mean Change From Baseline in Heart Rate||14 days prior to and up to 24 hours post-Eovist/Primovist MRI|The vital signs analyses were performed on participants in the Full Analysis Set (FAS) who had vital signs collected both precontrast and postcontrast|||beats/min||Standard Deviation|Mean
1426142|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection|The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels.|Up to 24 hours post-Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected|||Participants|||Number
1426143|NCT01043523|Primary|Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point|Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels.|14 days prior to Eovist/Primovist MRI|The laboratory analyses were performed on participants in the Full Analysis Set (FAS) who had laboratory values collected|||Participants|||Number
1426156|NCT01043094|Secondary|Number of Participants With Treatment Emergent Adverse Events||3 Days||||Participants|||Number
1426144|NCT01043523|Primary|Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.|Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened|When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI|Analysis is based on subjects with available precontrast and combined precontrast/postcontrast images (n=51)|||Percentage of participants||95% Confidence Interval|Number
1426145|NCT01043432|Primary|Iowa Gambling Test|Iowa Gambling Test - Total Raw Score The Iowa Gambling task requires examinees to sit in front of a computer screen displaying four decks of cards (Decks A, B, C, and D) and select a card from any of the four decks. Decks A and B are the disadvantageous decks because they produce high immediate gains however over time examinees will experience a higher loss. Decks C and D are the advantageous decks because they produce lower gains but over time examinees will experience smaller losses. Examinees will make 100 choices (trials). To measure performance, the 100 trials are divided, in order, into 5 'blocks’ of 20. A net score is calculated for each block as the number of cards selected from the advantageous decks minus the disadvantageous decks and the total raw score is the sum of the scores for blocks 1-5. The overall total score can range from -100 (worst outcome) to 100 (best outcome)and the score for each block can range from -20 to 20|One time - for the vast majority of participants the research protocol was initiated directly after informed consent procedures were completed (within hours). Negative values are possible with this measure, see Outcome Description.||||Total Raw on a scale from -100 to 100||Standard Deviation|Mean
1426146|NCT01043393|Secondary|Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis|The PGA scale is designed to evaluate the physician’s global assessment of the participant’s psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).|28 days|No statistical analysis provided for Percentage of Participants With a Physician’s Global Assessment (PGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)|||percentage of physician’s global assessm||Standard Deviation|Mean
1426147|NCT01043393|Secondary|Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis|"Body Surface Area (BSA) is a numerical score used to measure the physician’s assessment of the percentage of the participant’s total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600)~BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~%Body Surface Area Affected the Rule of Nine was be used"|28 days|"No statistical analysis provided for Percentage of Body Surface Area Affected by Psoriasis.~As the study is not powered sufficiently to perform efficacy statistical analysis, descriptive statistical analysis are presented on the mean change from baseline in % BSA affected"|||percentage of Body Surface Area Affected||Standard Deviation|Mean
1426148|NCT01043393|Primary|Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression|Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.|28 days||||participants|||Number
1426149|NCT01043185|Secondary|Number of Weakly Alkaline Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||Full Range|Median
1426150|NCT01043185|Secondary|Number of Weakly Acidic Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0–6.5 lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||95% Confidence Interval|Geometric Mean
1426151|NCT01043185|Secondary|Number of Acid Reflux Episodes|Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||95% Confidence Interval|Geometric Mean
1426152|NCT01043185|Primary|Total Number of Reflux Episodes During 24 Hours|Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)|Measured during 24 hours at 4 different visits with a 7-28 days interval between|Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.|||Episodes||95% Confidence Interval|Geometric Mean
1426153|NCT01043146|Primary|The Number of Participants Reporting Adverse Events (AEs)|To assess the safety and tolerability of COR-1.|45 days||||Participants|||Number
1426154|NCT01043133|Secondary|Clinical Note Completeness Score|The Note Completeness Score is a total score (range 1-31)earned when a clinical encounter note is compared against a note completeness score assessment tool designed by our research team. The tool measures 11 documentation components of the outpatient note. Each of the 11 components are scaled either 0-1 or 0-4 based on perceived importance by our physician designers.|immediately after intervention and 30+ days in follow-up||||score||Standard Deviation|Mean
1426158|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg|To compare the mean change in seated systolic blood pressure (SBP) in participants with baseline seated SBP ≥130 mmHg achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full Analysis set, participants with baseline seated SBP ≥130 mmHg and Week 8 (LOCF) value|||mmHg||95% Confidence Interval|Least Squares Mean
1426159|NCT01042977|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis set, subjects with non-missing baseline and Week 24 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
1426160|NCT01042977|Secondary|Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, subjects with non-missing baseline and Week 8 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
1426161|NCT01042977|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full Analysis Set, subjects with baseline BMI ≥27 kg/m2 and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1426162|NCT01042977|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values|||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
1426163|NCT01042977|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to Week 24|Full Analysis Set, subjects with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Number
1426164|NCT01042977|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
1426165|NCT01042938|Secondary|Pain at Radiation Treatment Site|The McGill Pain Questionnaire-Short Form (MPQ-SF) was used to determine the participants pain at treatment site. The MPQ-SF contains three subscales: affective pain, sensory pain, and perceived pain. This outcome measure compared the total pain score (range 0 to 50)and subscale scores (sensory subscale range 0 to 33; affective subscale range 0 to 12; perceived pain subscale 0 to 5) at the end of radiation therapy between the two treatment arms.|4-7 weeks (prescribed course of radiation)|All 30 participants that fully completed the trial were used in these analyses.|||units on a scale||Standard Deviation|Mean
1426166|NCT01042938|Secondary|Redness at Radiation Treatment Site|Redness at radiation treatment site was measured using a CR-400 Colorimeter (Konica Minolta). The colorimeter uses the L*a*b* color scale. We used a* values (redness) which range from 0.0 to 20.0. The lower the number value, the lower amount of redness. Therefore, high number values represent large amounts of redness.|4-7 weeks (prescribed course of radiation)|The 30 participants that fullt completed the trial were used in these analyses.|||units on a scale (0.0 to 20.0)||Standard Deviation|Mean
1426167|NCT01042938|Secondary|Moist Desquamation at Radiation Treatment Site|The presence of moist desquamation at the end of radiation treatment was examined between curcumin and placebo treatment groups. We compared the number of participants (or percentage) with moist desquamation between each treatment group.|4-7 weeks (prescribed course of radiation)|All 30 participants who completed the trial were used in all analyses.|||participants|||Number
1426168|NCT01042938|Primary|Severity of Dermatitis in Radiation Treatment Site in Breast Cancer Patients|The severity of radiation dermatitis was measured using the Radiation Dermatitis Severity (RDS)Scale which ranges from 0.0 to 4.0 with increments of 0.5. The RDS scale is a revised form of the NIH Common Toxicity Criteria to account for color and subtle texture changes in the skin. The worst dermatitis (i.e., highest RDS score) at the end of treatment was used for the primary analysis of severity of radiation dermatitis in each treatment group. Additionally, we performed repeated measure analyses to examine the severity of dermatitis over time in each arm.|4-7 weeks (prescribed course of radiation)|We used all 30 participants that fully completed the trial in all of our analyses.|||units on a scale||Standard Deviation|Mean
1426169|NCT01042795|Primary|Disease Free Survival|2-year disease free survival|2- year||||months|||Number
1426170|NCT01042678|Secondary|Number of Participants With Positive Binding Anti-MP0112 Antibodies|Blood samples were collected Pre-treatment (Baseline) and Weeks 4, 8 and 12. Samples were analyzed for Anti-MP0112 antibodies using an enzyme-linked immunosorbent assay.|12 weeks|All treated participants.|||Participants|||Number
1426171|NCT01042678|Secondary|Aqueous Humor Levels of MP0112|Aqueous humor (the thin, watery fluid in the eye) samples were collected from anterior chamber taps and were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|1 Week|All treated participants who consented to participate.|||nM||Full Range|Median
1426172|NCT01042678|Secondary|Serum Levels of MP0112|Blood samples were collected Pre-treatment (Baseline), Day 1 and 3, Weeks 1, 4, 12, 16. Serum samples (liquid portion of the blood after cells and clotting factors were removed) were sent to a laboratory for analysis. Levels of MP0112 were determined using an enzyme-linked immunosorbent assay.|16 Weeks|All treated participants.|||Nanomolar (nM)||Full Range|Median
1427154|NCT01033825|Secondary|Number of Subjects Experiencing Local Nasal AEs|Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.|Weeks 0-6|Intent to Treat Population|||participants|||Number
1426173|NCT01042678|Secondary|Change From Baseline in Foveal Thickness as Measured by Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina), was performed in the study eye after pupil dilation at Baseline and Week 16. A negative change from Baseline indicated improvement (less foveal thickness).|Baseline, Week 16|All treated participants.|||microns||Standard Deviation|Mean
1426174|NCT01042678|Secondary|Best-Corrected Visual Acuity (BCVA)|BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye at Baseline and Week 16. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the letters read correctly on the eye chart the better the vision.|Baseline, Week 16|All treated participants with data for a given time point were included for analysis.|||Letters||Standard Deviation|Mean
1426175|NCT01042678|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Safety and tolerability was assessed by vital signs, clinical laboratory evaluations, ophthalmological examinations, intraocular pressure, the presence of anti-drug antibodies and the collection of adverse events. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|16 weeks|All treated participants.|||Participants|||Number
1426176|NCT01042613|Secondary|Number of Skin Punctures|To assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique|At cannulation||||Skin punctures||Standard Deviation|Mean
1426177|NCT01042613|Secondary|Time Between Tourniquet Application and Successful Cannulation is Achieved or 4 Attempts Have Been Made (in Minutes).|To assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV 300 device as compared to the standard technique|At cannulation|Of the 146 patients, two patients were excluded due to missing time records.|||Minutes||Standard Deviation|Mean
1426178|NCT01042613|Primary|First Attempt Success Rate of Cannulation|This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. There is one timepoint for outcome data collection and it is prior to cannulation. Success (yes) is defined as needle insertion into target vein.|At cannulation|Patients (age 17 years or less) undergoing elective surgery or examination under anesthesia who do not have existing intravenous access.|||Participants|||Number
1426179|NCT01042600|Secondary|Mortality Rate||2 months||||participants|||Number
1426180|NCT01042600|Secondary|Number of Intubation Episodes Per Patient||7 days|||||||
1426181|NCT01042600|Secondary|Complications During Insertion of LMA||96 hrs|||||||
1426182|NCT01042600|Secondary|Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)||2 months|||||||
1426183|NCT01042600|Secondary|Rate of Pneumothorax||96 hrs|||||||
1426184|NCT01042600|Secondary|Days on Supplemental Oxygen||2 months|||||||
1426185|NCT01042600|Secondary|Days on Assisted Ventilation||2 months|||||||
1426186|NCT01042600|Secondary|Number of Surfactant Doses||96 hr|||||||
1426187|NCT01042600|Primary|Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).||96 hours||||participants|||Number
1426188|NCT01042535|Other Pre-specified|Phase 2 - Change in Biomarker Level|Biomarkers include serum kynurenine, serum tryptophan, C reactive protein, and circulating T-regulatory cell levels (CD4+ 25+ CD127low forkhead box protein 3+ (FoxP3+). Appropriate t-tests and/or Wilcoxon test will be employed to study changes over time.|Baseline to week 16|||||||
1426189|NCT01042535|Secondary|Phase 2 – Median Progression Free Survival (PFS) in Weeks|Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS: Time from study entry to documentation of radiologic progressive disease or death, assessed up to 3 years.|Up to 3 years|All evaluable participants at time of analysis|||weeks||Full Range|Median
1426190|NCT01042535|Secondary|Phase 2 – Number of Participants With Clinical Benefit From Chemotherapy After Vaccination|Clinical response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 3 years|All evaluable participants at time of analysis|||participants|||Number
1426191|NCT01042535|Secondary|Phase 1 - Number of Participants With Objective Response at 6 Weeks|Immunologic Response defined as Interferon-γ (IFN-γ) p53 T cell specific enzyme-linked immunospot (ELISPOT) assay count Summarized using both point estimates and the 95% exact confidence intervals based on the binomial distribution. Briefly, 2x10^5 mononuclear cells obtained from the peripheral blood of patients will be plated in quadruplicates in 96-well multiscreen mixed cellulose ester (HA) filtration plates, processed and incubated, spots will be visualized. The number of spots will be calculated per 10^6 cells. Untreated peripheral blood mononuclear cells (PBMNC) will represent a negative control and PBMNC stimulated with 10 µg/ml Concanavalin A (ConA) – positive control.|At 6 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod|||participants|||Number
1426192|NCT01042535|Primary|Phase 2 – Number of Participants With Stable Disease In Response to Study Therapy|Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 16 weeks|All evaluable participants at time of analysis|||participants|||Number
1426223|NCT01042236|Secondary|Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS|||Episodes per 24 hours.||Standard Deviation|Mean
1426193|NCT01042535|Primary|Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)|MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).|Up to 4 weeks|Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod|||indoximod dose in mg|||Number
1426194|NCT01042509|Secondary|Side Effects|Percentage of participants who experienced side effects|365 days|15 consecutive patients were included for the analysis with periodical clinical evaluations to assess adverse effects.|||Participants|||Count of Participants
1426195|NCT01042509|Primary|Clinical Response of Patients With Refractory Chronic GVHD Based on the Working Group Report 2006.|Overall response of participants to alemtuzumab and rituximab combination at day +30, +90 and +365 of follow-up|30, 90 and 365 days|All consecutive patients were included in an intention to treat analysis to evaluate clinical response to alemtuzumab and rituximab combination.|||percentage of participants|||Number
1426196|NCT01042496|Secondary|Glutamine/Glutamate Ratio Measured in the LDLPC at Baseline Using the ProFit Magnetic Resonance Spectroscopy (MRS) Technique|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline|Sample sizes varied between both scanning locations LDLPC and MACC and between metabolites due to imaging results/scan viability. Some subject scans yielded more viable information/ less noise during the scan process. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis.|||ratio||Standard Deviation|Mean
1426197|NCT01042496|Secondary|Mean Glutamate (GLU) Measured in the MACC and LDLPC Using the ProFit MRS Technique at Baseline for Both Groups, After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The 2D J-resolved averaged PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was then used for statistical analysis.|baseline, 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=8, LDLPC n=8, Bipolar group MACC n=13, LDLPC n=13. Bipolar group 12 weeks MACC n=8, LDLPC n=17. The control group did not do the procedure at 12 weeks.|||Institutional Units (IU)||Standard Deviation|Mean
1426198|NCT01042496|Secondary|N-acetylaspartic Acid (NAA) Measured in the MACC and LDLPC Using the Long TE (TE80) PRESS MRS Technique at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar (BP) Group and BP Responders and Non-responders|Two different MRS sequences were used to measure the brain chemicals in a single 2 x 2 x 2 cm cube located in the center of anterior cingulate cortex: an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of CSF in the head. The MRS voxel was overlaid onto the CSF map and the fraction of CSF within the voxel measured. This CSF-corrected measurement was used for statistical analysis.|baseline, 12 weeks|Samples varied due to imaging results/scan viability. Baseline: control group MACC (M) and LDLPC (L) n=8, BP whole M n=28 (3 didn't complete), L n=27, BP Responders M n=13, L n=11, BP nonresponders M and L n=12; BP whole 12 weeks M and L n=16. BP Responders M and L n=10, BP nonresponders M and L n=6. Controls didn't do the procedure at 12 weeks.|||Institutional Units (IU)||Standard Deviation|Mean
1426199|NCT01042496|Secondary|Glutamate+Glutamine (GLX) Measured in Mid Anterior Cingulate Cortex (MACC) & Left Dorsal Lateral Prefrontal Cortex (LDLPC) Using Long TE PRESS MRS Technique at Baseline for Both Groups; After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|Two different MRS sequences were used to measure the brain chemicals in in anterior cingulate and left dorsal lateral prefrontal cortex : an intermediate echo-time PRESS sequence and a 2D J-resolved averaged PRESS sequence. (Note: The intermediate echo-time PRESS sequence was used for this outcome measure.) Spectroscopic data were inspected for quality; subjects whose data were contaminated by artifact were excluded from the study. Spectra were then processed using LCModel to quantify brain chemical levels. Regular brain MRI images were segmented, yielding a map of the amount of cerebrospinal fluid (CSF); the MRS voxel was overlaid onto the CSF map and the fraction of CSF was measured. This CSF corrected measurement was used for statistical analysis.|baseline, after 12 weeks|Sample sizes varied due to imaging results/scan viability. Excessive noise resulted in poor metabolite readings which in-turn were not used in the final analysis. Baseline: control group MACC n=7, LDLPC n=8, Bipolar group MACC n=18, LDLPC n=27. Bipolar group 12 weeks MACC n=12, LDLPC n=16. The control group did not do the procedure at 12 weeks.|||Institutional Units (IU)||Standard Deviation|Mean
1426224|NCT01042236|Secondary|Change From Baseline in Closing Urethral Elastance at Day 7|Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS|||cmH2O/mm^2||Standard Deviation|Mean
1426200|NCT01042496|Primary|Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Baseline for Both Groups, and After 12 Weeks of Lamotrigine Monotherapy for the Bipolar Group|The MADRS is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). A score of less than 12 is considered clinical remission of depression.|baseline, 12 weeks|The control group only did the MADRS depression rating scale at baseline. 25 participants in the Bipolar group took the MADRS depression rating scale at 12 weeks.|||units on a scale||Standard Deviation|Mean
1426201|NCT01042392|Secondary|Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|8 weeks + 1 day|All randomized patients except one patient from Aliskiren arm who was lost to follow up after visit 2.|||Participants|||Number
1426202|NCT01042392|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose|The change in blood pressure was measured between visit 4 (end of the period of double-blind active treatment which was at week 8) and visit 5 (48 hours after the last active dose taken) in the group of patients who received aliskiren or placebo and those who received ramipril or placebo. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|From 8 weeks to 48 hours after week 8|Per-protocol missed dose population included all per protocol population patients who had received the study treatment for period 3 according to the protocol (duration of period 3 and treatment intake). Patients with observation at both time points were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
1426203|NCT01042392|Secondary|Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)|"The sub-groups were: Riser = patients with >= 55 mmHg difference between the mean SPB measured at the morning surge and the mean minimal SBP measured during the night. The Non-risers in whom the difference is <55 mmHg. Patients called dippers in whom there was a decrease in average nocturnal SBP ≥ 10% compared with average daytime SBP, in contrast to patients non-dippers  in whom this difference was <10%."|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at different categories were included in this analysis.|||mmHg||Standard Deviation|Mean
1426204|NCT01042392|Secondary|Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the eve of visit 4 (week 8), the device attached to the ambulatory blood pressure non-dominant arm of the patient. The difference between mean-hour maximum SBP mean-hour minimum SBP between 1 am and 8 am was measured.|At week 8|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM measurements over 24 hours were included in this analysis.|||mmHg||Standard Deviation|Mean
1426205|NCT01042392|Secondary|Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables.|Baseline to 4 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.|||mmHg||Standard Error|Least Squares Mean
1426206|NCT01042392|Secondary|Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night|Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the day before visit 4, the device attached to the ambulatory blood pressure non-dominant arm of the patient. The BP morning surge was defined as the average of the measurements taken during the first 2 hours after waking the patient. The minimal night blood pressure was defined as the average of the two lowest BP measures (the lowest hourly average) recorded during night time.|After 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with ABPM to evaluate the occurrence or absence of a morning peak were included in this analysis.|||Participants|||Number
1426207|NCT01042392|Secondary|Percentage of Patients With Controlled Blood Pressure|"The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings.~Controlled blood pressure (BP) is defined as mean office systolic BP/ diastolic BP < 140/90 mmHg."|At 4 and 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at each time point were included in this analysis.|||Percentage|||Number
1426222|NCT01042236|Secondary|Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours|Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.|||Percent||Full Range|Median
1426208|NCT01042392|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of variance included treatment factor and baseline value of mean sitting DBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5. Patients with observation at both time points were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
1426209|NCT01042392|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable.|Baseline to 8 weeks|Intent to treat population included all randomized patients who had received at least one dose of study drug. It also excluded all those patients from centers that reported more than 90% of BP measurements rounded to 0 or 5.|||mmHg||Standard Error|Least Squares Mean
1426210|NCT01042366|Primary|ELISpot Response to Melanoma|Peripheral blood CD8+ and CD4+ T cell responses against autologous tumor cells, and HLA-presented melanoma epitopes, using ELISPOT and MHC-peptide tetramer assays.|12 mo|Patients who met inclusion criteria and received at least 3 doses of the vaccine|||participants|||Number
1426211|NCT01042366|Primary|Delayed Type Hypersensitivity (DTH) Response|Delayed type hypersensitivity (DTH) response to antigen-loaded autologous, dendritic cell vaccine (DC) injected intradermal in vivo|12 mo|Patients who met inclusion criteria and received at least 3 doses of the vaccine|||participants|||Number
1426212|NCT01042288|Secondary|Frequency of Adverse Events and Severity as a Measure of Toxicity|Assessed using NCI CTCAE v4.0|Every 3 weeks (1 cycle) for 6 cycles, then every 7 weeks thereafter||||participants|||Number
1426213|NCT01042288|Secondary|Objective Response Rate||Projected 18 months|All patients evaluated for response|||percentage of evaluated participants|||Number
1426214|NCT01042288|Secondary|Median Overall Survival (OS)|Defined as the time between Day 1-Cycle 1 to the date of death from any cause.|18 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
1426215|NCT01042288|Secondary|Median Progression-free Survival (PFS)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression or death.|Assessments by clinical evaluation, radiographic status, and date of disease progression, estimated 18 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
1426216|NCT01042288|Primary|Median Time to Progression (TTP)|Defined as the time between Day 1-Cycle 1 and date of first documented disease progression assessed using Response Evaluation Criteria in Solid Tumors (RECISTS) v1.1.|18 months|All enrolled and treated patients|||months||95% Confidence Interval|Median
1426217|NCT01042236|Secondary|Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration|Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Baseline, Day 7 of each period|Full Analysis Set (FAS): all randomized subjects who had taken at least one dose of study treatment; (n)=number of participants with observations (non-missing concentrations)|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1426218|NCT01042236|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only subjects with >0 participants at baseline were to be included in the analysis.|||Percent||Full Range|Median
1426219|NCT01042236|Secondary|Urgency Urinary Incontinence Episode Frequency Per 24 Hours|Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS|||Episodes per 24 hours.||Standard Deviation|Mean
1426220|NCT01042236|Secondary|Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis.|||Percent||Full Range|Median
1426221|NCT01042236|Secondary|Stress Incontinence Episode Frequency Per 24 Hours|Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.|Baseline, Day 7 of each period|PPAS|||Episodes per 24 hours.||Standard Deviation|Mean
1426276|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 6 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 6 months||||seconds||95% Confidence Interval|Mean
1426225|NCT01042236|Secondary|Change From Baseline in Opening Urethral Elastance at Day 7|Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS|||cmH2O/millimeter(mm)^2||Standard Deviation|Mean
1426226|NCT01042236|Secondary|Change From Baseline in Closing Urethral Pressure at Day 7|Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|PPAS|||cmH20||Standard Deviation|Mean
1426227|NCT01042236|Primary|Change From Baseline in Opening Urethral Pressure (OUP) at Day 7|OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.|Baseline, Day 7 of each period|Per Protocol Analysis Set (PPAS): all randomized participants who completed the study, received treatment in all 3 study periods until end of treatment visit in the third study period, and had not violated any of the inclusion / exclusion criteria or deviated from the protocol in a way that could affect the outcome of the study.|||centimeter of water (cmH2O)||Standard Deviation|Mean
1426228|NCT01042158|Secondary|6-minute Walk Distance|patients were made to take a walk of normal speed to cover a distance in 6 minutes and distance covered was recorded. This was done at baseline (week o) and then repeated t 36 weeks.|baseline and 36 weeks||||meters||Standard Deviation|Mean
1426229|NCT01042158|Secondary|Tricuspid Annular Plane Systolic Excursion (TAPSE)|The extent of displacement of the tricuspid valves, termed as Tricuspid Annular Plane Systolic Excursion (TAPSE) was measured using a trans-thoracic echocardiogram following Right heart catheterization.|baseline and 36 weeks||||cm||Standard Deviation|Mean
1426230|NCT01042158|Primary|Pulmonary Vascular Resistance (PVR)|Change in Pulmonary Vascular Resistance (PVR) was ascertained via Right Heart Catheterization (RHC) measurement of the difference between the PVR at baseline and 36 weeks|baseline 36 weeks||||Wood units||Inter-Quartile Range|Median
1426231|NCT01042158|Primary|Right Ventricular (RV) Mass|Assessment of change in Right ventricular mass was done via standard volumetric cine images of the right heart at baseline and comparing it to that at the end of 36 weeks using Cardiac Magnetic Resonance Imaging studies.|baseline and 36 weeks||||grams||Inter-Quartile Range|Median
1426232|NCT01042145|Secondary|Number of Participants With Reported Side Effects||12 days||||percentage of participants|||Number
1426233|NCT01042145|Secondary|Time Missed From Work||12 days||||Hours||Standard Deviation|Mean
1426234|NCT01042145|Secondary|Parental Stress|Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.|12 days||||days||Standard Deviation|Mean
1426235|NCT01042145|Secondary|Nights With Disturbed Sleep||12 days||||nights||Standard Deviation|Mean
1426236|NCT01042145|Secondary|Duration of Croup Symptoms||12 days||||days||Standard Deviation|Mean
1426237|NCT01042145|Primary|Additional Health Care|The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care.|11 days||||percentage of participants||95% Confidence Interval|Number
1426238|NCT01042093|Secondary|Knee Society Pain Scores at 6 Week Follow-up Appointment|Patients were assessed for pain at their 6 week follow-up appointment using the Knee Society Rating Scale. Using this scale patients are given a pain score ranging from 0 (severe pain) to 50 (No Pain). This is determined as follows: No pain/50 points, Mild or occasional pain/45 points, pain with stairs only/40 points, pain with walking and stairs/30 points, Moderate/occasional pain/ 20 points,continual pain/10 points, severe pain/0 points. We report the mean score for each group. A higher score represents a better outcome.|6 weeks after surgery||||Scores on a scale 0-50||Full Range|Mean
1426239|NCT01042093|Secondary|Narcotic Consumption During Hospitalization|A variety of pain medications were used after surgery to keep patients comfortable. Narcotic use was recorded as morphine equivalents. We report the mean narcotic consumption for each group for the day of surgery as well as post operative day 1,2, and 3.|4 days||||mg||Standard Deviation|Mean
1426240|NCT01042093|Primary|Numerical Rating Scale (NRS) Pain Scores During Hospitalization.|Patient pain was assessed during hospitalization using the VAS Pain Scale, a numerical rating scale ranging from 0 (no pain) to 10 (severe pain). A lower score represents a better outcome. Pain was assessed preoperatively, 1 hour postoperatively in the post anesthesia unit, and then every 8 hours on the Orthopedic inpatient unit, for a duration of 2 days.|2 days after surgery||||scores on a scale 0-10||Standard Deviation|Mean
1426241|NCT01041976|Secondary|Employment|"Yes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up.~Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up."|18 months||||participants|||Number
1426242|NCT01041976|Primary|Participation in Vocational Rehabilitation Services|"Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up.~Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up."|18 months||||participants|||Number
1426243|NCT01041859|Secondary|Change From Baseline in the EuroQoL-5 Dimension (EQ-5D) Health Status Index at the Week 12 Endpoint|EQ-5D has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on a categorical scale of 1-3 with 1=no problems, 2=some problems, 3=extreme problems. The health state index is a weighted combination of the 5 items. It has a range of 0 to 1, with 0=deceased and 1=full health.|Double-blind Baseline and End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.|||units on a scale||Standard Deviation|Mean
1427155|NCT01033825|Secondary|Percentage of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population|||percentage of subjects|||Number
1426244|NCT01041859|Secondary|Change From Baseline of Open-Label in the Pain Intensity Subscale of the Brief Pain Inventory (BPI) at the Week 12 Double-Blind Endpoint|The BPI is a 12-item questionnaire to evaluate the intensity of pain and the degree to which pain interferes with function. It includes 4 items assessing current pain intensity and pain at its worst, least, and on average over the past day using an 11-point scale from 0 = no pain to 10 = pain as bad as you can imagine. The pain intensity subscale score is defined as the mean of the scores from these 4 items.|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) endpoint.|||units on a scale||Standard Deviation|Mean
1426245|NCT01041859|Secondary|Distribution of Patient Global Impression of Change at Week 12 Endpoint|Patient Global Impression of Change (PGIC) is a patient-rated assessment of overall neuropathic pain since the start of treatment using a categorical scale 1-7, where 1 is ‘very much improved’ and 7 is ‘very much worse’|End of Double-Blind Treatment at 12 Weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point|||percentage of participants|||Number
1426246|NCT01041859|Secondary|Responder Analysis: Proportion of Patients With At Least 50% Improvement From Baseline of Open-Label on the Numerical Rating Scale (NRS) at the Week 12 Endpoint|"The NRS was a twice-daily pain assessment in which patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point scale with a score of 0 indicating no pain and a score of 10 indicating pain as bad as you can imagine."|Open-label Baseline and End of Double-Blind Treatment at 15 Weeks (3 weeks open-label plus 12 weeks double-blind)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation.|||percentage of participants|||Number
1426247|NCT01041859|Primary|Change From Double-Blind Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12|"For this twice daily pain assessment, the patients were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Double-Blind Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period)|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation|||units on a scale||Standard Deviation|Mean
1426248|NCT01041781|Secondary|Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Third Quartile (Q3)|Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q3, 27.86). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 5 years|Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.|||months||95% Confidence Interval|Median
1426249|NCT01041781|Secondary|Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the Median Quartile (Q2)|prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the median quartile (Q2, 15.38). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 5 years|Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.|||months||95% Confidence Interval|Median
1426250|NCT01041781|Secondary|Prognostic Value of Urinary Prostaglandin Metabolites (PGE-M) Levels for Worse PFS for Patients Who Had Baseline Urinary PGE-M Above/Below the First Quartile (Q1)|Prognostic value of urinary prostaglandin metabolites (PGE-M) levels for worse PFS for patients who had baseline urinary PGE-M above/below the first quartile (Q1, 10.09). Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 5 years|Patients on the placebo arm with urinary PGE-M evaluated at baseline were included in the analysis.|||months||95% Confidence Interval|Median
1426251|NCT01041781|Secondary|Incidence of Toxicities as Assessed by NCI CTCAE v. 4.0|The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment|Up to 5 years||||percentage of patients|||Number
1426252|NCT01041781|Secondary|Response Rate|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher’s exact test|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
1426253|NCT01041781|Secondary|Overall Survival|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time between randomization and death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
1426254|NCT01041781|Primary|Progression-free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time between randomization and disease relapse or death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
1426255|NCT01041638|Secondary|Overall Survival|Estimated using Kaplan-Meier curves.|From enrollment until death, or until last contact with the patient, up to 5 years|||||||
1426256|NCT01041638|Secondary|Event-free Survival|Estimated using Kaplan-Meier curves.|From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 5 years|||||||
1426257|NCT01041638|Primary|Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).|Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.|Up to 5 years|"There was one patient that did not receive treatment, represented on the baseline form as withdrawal by patient, not included in outcome measure tabulation."|||percentage of participants|||Number
1426258|NCT01041573|Secondary|Rate of Subjects With Abnormal Laboratory Parameters||study duration|||||||
1426259|NCT01041573|Secondary|Rate of Subjects With Unsolicited AEs up to Day 56 and up to Month 7||Day 56 and up to Month 7|||||||
1426260|NCT01041573|Secondary|Rate of Subjects With Solicited Local and Systemic AEs||study duration|||||||
1426261|NCT01041573|Secondary|Rate of Subjects With SAEs and Medically Attended AEs up to Month 7||up to Month 7|||||||
1426262|NCT01041573|Secondary|Geometric Mean Titers (GMT) for JEV Neutralizing Antibodies and SCR at Days 0, 56 and at Month 7||Day 0, 56 and at Month 7|||||||
1426263|NCT01041573|Primary|Rate of Subjects With Serious Adverse Events and Medically Attended Adverse Events Until Day 56 After First Vaccination|Comparing study participants 1 year and above receiving IC51 0.25mL, IC51 0.5 mL and Havrix|until Day 56||||percentage of participants||95% Confidence Interval|Number
1426264|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
1426265|NCT01041417|Secondary|Change in Score on Physical Functioning Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The physical functioning represents limitations in physical activities because of health problems. Physical functioning is a summary measure derived from 8 scale scores and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
1426266|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
1426267|NCT01041417|Secondary|Change in Score on Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The MCS represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). MCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
1426268|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 6 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
1426269|NCT01041417|Secondary|Change in Score on Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) From Baseline to 3 Months|The SF-36 is a standard quality of life instrument. The PCS represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). PCS is a summary measure derived from 8 scale score and the score ranges from 0-100; higher scores indicate better performance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
1426270|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
1426271|NCT01041417|Secondary|Change in Stair Climbing Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with stair climbing elements.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
1426272|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
1426273|NCT01041417|Secondary|Change in Walking Speed Score on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking speed.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
1426274|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 6 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Mean
1426275|NCT01041417|Secondary|Change in Walking Distance Scores on Walking Impairment Questionnaire (WIQ) From Baseline to 3 Months|The WIQ quantifies walking difficulty on a 100-point scale, in which 0 indicates extreme difficulty and 100 indicates no difficulty with walking distance.|Baseline, 3 months||||units on a scale||95% Confidence Interval|Mean
1426277|NCT01041417|Secondary|Change in Claudication Onset Time (COT) From Baseline to 3 Months|Claudication is pain, tired or weak feeling that occurs in the legs, usually during activity such as walking. The COT was measured as the time to onset of the participant's typical claudication as the maximum distance the patient could walk on the treadmill.|Baseline, 3 months||||seconds||95% Confidence Interval|Mean
1426278|NCT01041417|Secondary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 6 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 6 months||||seconds||95% Confidence Interval|Mean
1426279|NCT01041417|Primary|Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months|Exercise Tolerance Test (ETT) was conducted using the Gardner protocol. Participants exercised on a treadmill, starting at 2.0 mph. The intensity of exercise (speed) was increased in grade of 2% every 2 minutes. Participants were asked to exercise until symptom limitation and the time measured in seconds from the ETT was used for data analysis.|Baseline, 3 months||||seconds||95% Confidence Interval|Mean
1426280|NCT01041404|Secondary|Trastuzumab Maximum Serum Concentration (Cmax)|Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population|||mg/L||90% Confidence Interval|Median
1426281|NCT01041404|Secondary|Trastuzumab Minimum Serum Concentration (Cmin)|Median Cmin (measured as milligrams per liter [mg/L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|PK Population|||mg/L||90% Confidence Interval|Median
1426282|NCT01041404|Secondary|Steady State Trastuzumab Area Under the Concentration (AUC)|Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by [*] day per liter [L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.|Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106|Pharmacokinetic (PK) population: all participants with at least 1 measurement of trastuzumab serum concentration associated with a documented trastuzumab dosing history.|||mg*day/L||90% Confidence Interval|Median
1426283|NCT01041404|Secondary|Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight|Change in body weight was categorized as an increase of greater than (>)5 percent (%), no change (plus or minus [±]5%), decrease of >5-10%, or a decrease of >10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS. 273 and 283 participants were analyzed in the Fluoropyrimidine, Cisplatin and Trastuzumab, Fluoropyrimidine, Cisplatin groups, respectively.|||percentage of participants|||Number
1426284|NCT01041404|Secondary|Body Weight (Kilograms [kg]) at BL||BL|FAS|||kg||Full Range|Median
1426285|NCT01041404|Secondary|Percentage of Participants With a Change in Analgesic Medication During the Study|Analgesic medications were recorded throughout the study until disease progression.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
1426286|NCT01041404|Secondary|Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)|The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.|||mm||Standard Error|Mean
1426287|NCT01041404|Secondary|EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores|The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n = number of participants assessed for a specific parameter at a given visit.|||scores on a scale||Standard Error|Mean
1426288|NCT01041404|Secondary|European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.|BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; n (number) = number of participants assessed for a specific parameter at a given visit.|||scores on a scale||Standard Error|Mean
1426289|NCT01041404|Primary|Overall Survival - Time to Event|The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||months||95% Confidence Interval|Median
1426290|NCT01041404|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants||95% Confidence Interval|Number
1426291|NCT01041404|Secondary|Duration of Response|The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1426292|NCT01041404|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS; only participants with a CR or PR were included in the analysis.|||percentage of participants|||Number
1426293|NCT01041404|Secondary|Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST)|For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants||95% Confidence Interval|Number
1426294|NCT01041404|Secondary|Time to Progression - Time to Event|The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||months||95% Confidence Interval|Median
1426295|NCT01041404|Secondary|Time to Progression (TTP) - Percentage of Participants With an Event|TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
1426296|NCT01041404|Secondary|Progression-Free Survival - Time to Event|The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||months||95% Confidence Interval|Median
1426297|NCT01041404|Secondary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
1426298|NCT01041404|Primary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.|Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis|FAS|||percentage of participants|||Number
1426299|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|6 months||||meters per second (m/s)||Standard Deviation|Mean
1426300|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|3 months||||meters per second (m/s)||Standard Deviation|Mean
1426301|NCT01041287|Primary|Pulse Wave Velocity (Measure of Arterial Stiffness)|The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).|Baseline||||meters per second (m/s)||Standard Deviation|Mean
1427156|NCT01033825|Secondary|Number of Subjects Who Discontinue Due to AEs||Weeks 0-6|Intent to Treat Population.|||participants|||Number
1427157|NCT01033825|Secondary|Percentage of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population|||percentage of subjects|||Number
1426302|NCT01041209|Secondary|Treatment Failure in Each Group|"Treatment failure was defined as: Persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.~Proportion of patients with treatment failure was compared between both groups (BPS vs Guideline)."|1, 2, 5, 7 and 10 days from baseline||||participants|||Number
1426303|NCT01041209|Primary|Use of Antibiotics in Each Group|The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).|At baseline||||participants|||Number
1426304|NCT01040871|Secondary|Change in Fatigue and Patient Utility Scores||18-24 months|||||||
1426305|NCT01040871|Secondary|Overall Survival Rate at 1-year|Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.|1 year|Intent to Treat Population|||percentage of partipants||95% Confidence Interval|Number
1426306|NCT01040871|Secondary|Progression-free Survival (PFS)Rate at 1-year|Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death.|1 year|Intent to Treat Population|||percentage of partipants||95% Confidence Interval|Number
1426307|NCT01040871|Secondary|Subsequent Anti-lymphoma Therapy Rate at 1-year|Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive.|1 year|Intent to Treat Population|||percentage of participants||95% Confidence Interval|Number
1426308|NCT01040871|Secondary|Rate of Durable Complete Response|Proportion of subjects who achieved a CR with duration of at least 6 months|Median follow up approx 12 months||||percentage of participants||95% Confidence Interval|Number
1426309|NCT01040871|Secondary|Rate of Durable Response|Proportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.|Median follow up approx. 12 months||||percentage of participants||95% Confidence Interval|Number
1426310|NCT01040871|Secondary|Overall Response Rate|"Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment|||percentage of participants||90% Confidence Interval|Number
1426311|NCT01040871|Primary|Complete Response (CR) Rate|"Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.~Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~PET scan was negative.~The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared.~If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy.~No new sites of disease were detected."|6 cycles|All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment|||percentage of participants||90% Confidence Interval|Number
1426312|NCT01040858|Secondary|Satisfaction With Life Scale|A brief measure of global life satisfaction. It measures the sum of satisfaction ratings for 5 items on a scale from 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 5 to 35 with higher scores indicating greater satifaction.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426313|NCT01040858|Secondary|Severity of Dependence Scale|A brief substance dependence measure. It measures the sum of severity ratings for 5 symptoms on a scale from 0 (never) to 3 (always). The total score ranges from 0 15.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426314|NCT01040858|Secondary|Beck Depression Inventory, Second Edition|A depression symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severity ratings for 21 symptoms on a scale from 0 (none) to 3 (severe). BDI total score ranges from 0 to 63.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426315|NCT01040858|Secondary|PTSD Checklist-Military Version|A PTSD symptom severity measures based on DSM-IV diagnostic criteria. It measures the sum of severit ratings for 17 symptoms on a scale from 1 (not at all) to 5 (extremely). PCL-M total score ranges from 17 to 85.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426316|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Verbal Fluency Subtest|A measure of verbal fluency, generativity, and processing speed. A scaled score of Letter Fluency portion of the test was used. The scores ranged from 0 to 20 with higher scores indicating better outcomes.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1427158|NCT01033825|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs).||Weeks 0-6|Intent to Treat Population.|||participants|||Number
1426317|NCT01040858|Secondary|Delis-Kaplan Executive Function System, Trails Subtest|A visual-motor task used to measure flexibility in thinking (executive function) and processing speed. Scaled score for Condition 4 was used, and possible scores ranges from 0 to 20 with higher scores indicating better outcome.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426318|NCT01040858|Secondary|Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest|A measure of attention and working memory. Total score was used, and it ranges from 0 to 48, with higher scores indicating greater attentional capacity.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426319|NCT01040858|Secondary|Hopkins Verbal Memory Test-Revised|Verbal list learning and delayed recall. Total recall T-score was used for the analyses. Total recall T-score ranges from 13 (severely impaired) to 86 (very superior).|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426320|NCT01040858|Secondary|Memory Compensation Questionnaire|The MCQ is a 44-item self-report questionnaire that rates the extent to which patients use various strategies to improve memory performance relevant to daily living. The MCQ measures the sum of memory strategies used on a scale from 0 (never) to 4 (always). The total score ranges from 0 to 176.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426321|NCT01040858|Secondary|The Neurobehavioral Symptom Inventory|A post-concussive symptom measure. The total score on the measure is the sum of severity ratings for 22 symptoms on a scale from 0 (none) to 4 (very severe). NSI total score ranges from 0 to 88.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426322|NCT01040858|Secondary|Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &|A 16-item self-report severity measure of prospective and retrospective memory problems relevant to everyday life. The measure reports the sum of severity ratings on a scale from 1 (never) to 5 (very often). The PRMQ total score ranges from 16 to 80.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426323|NCT01040858|Primary|Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version|A self-report measure of severity of attention and organizational problems. It measures the sum of severity ratings on a scale from 0 (never) to 4 (very often). The total score ranges from 0 to 64.|Week 10|The number of participants who completed this measure at Week 10 was lower than baseline due to missing data, or incomplete data.|||units on a scale||Standard Deviation|Mean
1426324|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colchicine With Norethindrone/Ethinyl Estradiol|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
1426325|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Ethinyl Estradiol With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1426326|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Ethinyl Estradiol With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.||||ng/mL||Standard Deviation|Mean
1426327|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Placebo|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1426328|NCT01040845|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Colchicine|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng-hr/mL||Standard Deviation|Mean
1426329|NCT01040845|Primary|Maximum Plasma Concentration of Colchicine With Norethindrone/Ethinyl Estradiol at Steady State (Cmax, ss)|The maximum or peak concentration that Colchicine with Norethindrone/Ethinyl Estradiol reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
1426330|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1426331|NCT01040845|Primary|Maximum Plasma Concentration of Ethinyl Estradiol With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Ethinyl Estradiol with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1426332|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Placebo at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Placebo reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1426333|NCT01040845|Primary|Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss)|The maximum or peak concentration that Norethindrone with Colchicine reaches in the plasma at steady state. Steady state refers to the point that constant concentration of drug is achieved subsequent to administration of constant doses of that drug given at constant intervals.|Day 21 of each cycle - plasma concentrations were drawn prior to the morning dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 (prior to pm colchicine/placebo dose), and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
1426334|NCT01040832|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Time from first dose up to Day 42 to 49 after last dose of trial treatment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|Safety population included all the participants who received at least 1 dose study drug.|||participants|||Number
1426335|NCT01040832|Secondary|Overall Survival (OS) Time|The overall survival (OS) time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date, whatever was earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date, (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment. Overall survival data was analyzed only for participants who received cetuximab plus EMD 1201081.|||months||95% Confidence Interval|Median
1426336|NCT01040832|Secondary|Percentage of Participants With Disease Control: Independent Read Assessments|Percentage of participants with disease control, defined as having achieved CR or PR or stable disease (SD) as the tumor response according to radiological assessments (based on RECIST Version 1.0 criteria), was reported. As per RECIST v1.0 for target lesions and assessed by MRI: CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.|||percentage of participants||95% Confidence Interval|Number
1426337|NCT01040832|Secondary|Percentage of Participants With Objective Response: Independent Read Assessments|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as assessed by Independent Read. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Every 6 weeks until disease progression, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.|||percentage of participants||95% Confidence Interval|Number
1426338|NCT01040832|Primary|Progression-free Survival (PFS) Time: Independent Read Assessments|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause within 60 days of the last tumor assessment or randomization. Participants without event were censored on the date of last tumor assessment.|Every 6 weeks until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, 17 Dec 2009 until cut-off date (11 Jan 2012)|ITT population included all the randomized participants who had received study treatment.|||months||95% Confidence Interval|Median
1426339|NCT01040819|Primary|Plasma 15-epi-lipoxin A4|Plasma 15-epi-LXA4 levels|2 months||||ng/ml||Standard Error|Mean
1426340|NCT01040793|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
1426341|NCT01040793|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
1426342|NCT01040793|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
1426343|NCT01040793|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||beats/min||Standard Deviation|Mean
1426344|NCT01040793|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||mmHg||Standard Deviation|Mean
1426345|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
1426346|NCT01040793|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
1426347|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426348|NCT01040793|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426349|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426350|NCT01040793|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426351|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426352|NCT01040793|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426353|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426354|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426355|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426356|NCT01040793|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426357|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
1426358|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
1426359|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426360|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426361|NCT01040793|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.~Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
1426362|NCT01040793|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426363|NCT01040793|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||seconds||Standard Error|Geometric Mean
1426364|NCT01040780|Secondary|Safety and Tolerability|"Adverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term.~Grade 3 = Severe Grade 4 = Life-threatening or disabling"|Assessed over two years||||participants|||Number
1426365|NCT01040780|Secondary|Time To Progression|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.|2-7 months||||months||95% Confidence Interval|Median
1426366|NCT01040780|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline|While receiving study treatment; assessed every 21 days until progression||||percentage of patients|||Number
1426367|NCT01040780|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death||||months||95% Confidence Interval|Median
1426368|NCT01040780|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|2-7 months|All patients who received at least one dose of study drug with measurable disease at baseline.|||months||95% Confidence Interval|Median
1426369|NCT01040728|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.|||participants|||Number
1426370|NCT01040728|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment for the first period. Trough values were the mean of obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426371|NCT01040728|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment for the first period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426372|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426373|NCT01040728|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data for this endpoint after first dose of treatment.|||Liter||Standard Error|Mean
1426374|NCT01040728|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426375|NCT01040728|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426376|NCT01040728|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426377|NCT01040728|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment for the first period. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426378|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426379|NCT01040728|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment for the first period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data for this endpoint after first dose of treatment.|||Liter||Standard Error|Mean
1426380|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of treatment for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426381|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the treatment at the first treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data for this endpoint after first dose of treatment.|||Liter||Standard Error|Mean
1426382|NCT01040728|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose at the first randomized treatment visit for the first period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426383|NCT01040728|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to the am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426384|NCT01040728|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the first morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either of the co-primary endpoints. FAS including all patients with evaluable data for this endpoint after six weeks.|||Liter||Standard Error|Mean
1426385|NCT01040689|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.|||percentage of participants|||Number
1426386|NCT01040689|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose in first treatment period. Trough values were mean of the values obtained 23 h and 23 h 50 min after the last dose of study drug after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426387|NCT01040689|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose in first treatment period. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426388|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426389|NCT01040689|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose in the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment|FAS including all patients with evaluable data after first dose of treatment.|||Liter||Standard Error|Mean
1426390|NCT01040689|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426391|NCT01040689|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose of first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to last dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426614|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1426392|NCT01040689|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to first dose in first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426393|NCT01040689|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of first treatment period. Trough values were the mean of values obtained 23 hours and 23h 50min post the last dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426394|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after six weeks of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and 6 weeks|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426395|NCT01040689|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of first treatment period. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the first dose of treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Study baseline and first day of dosing|FAS including all patients with evaluable data after first dose of treatment.|||Liter||Standard Error|Mean
1426396|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426397|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period|FAS including all patients with evaluable data after first dose of treatment.|||Liter||Standard Error|Mean
1426398|NCT01040689|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the first visit of the first treatment period. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426399|NCT01040689|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426415|NCT01040403|Secondary|PEF AUC 0-3h and AUC 0-6h Responses|Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS|||L/min||Standard Error|Mean
1426615|NCT01038752|Secondary|To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.|Insufficient data.|Randomization date to date of death|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1426400|NCT01040689|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with baseline (pre-dose) data and any evaluable post-dosing data for either co-primary endpoint from the same treatment period. FAS including all patients with evaluable data after six weeks.|||Liter||Standard Error|Mean
1426401|NCT01040624|Secondary|Collect and Analyze Treatment, Biologic and Diagnostic Information That May Impact Quality of Life, Disease Control, Morbidity and/or Survival Outcomes.||After radiation: every 6 months for 3 years, then annually for 20 years|||||||
1426402|NCT01040624|Secondary|Collect and Analyze Quality of Life, Treatment-related Late Morbidity, Disease Control, and Survival Outcome Parameters.||After radiation: every 6 months for 3 years, then annually for 20 years|||||||
1426403|NCT01040624|Primary|Acute Grade 3 or Higher Treatment-related Toxicity Rate.|Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria.|6 months after the completion of radiation therapy||||participants|||Number
1426404|NCT01040403|Secondary|Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry|Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for systolic and diastolic blood pressure at baseline and day 29.|||mmHg||Standard Deviation|Mean
1426405|NCT01040403|Secondary|Pulse Rate Recorded in Conjunction With Spirometry|Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).|Baseline and 30 min post-dose on day 29|TS which comprised all patients who were dispensed study medication, were documented to have taken at least 1 dose of investigational treatment and had available data for pulse rate at baseline and day 29.|||bpm||Standard Deviation|Mean
1426406|NCT01040403|Secondary|Patients Global Rating|"Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29.~The score was evaluated on a 7-point scale :~1 : very much better~2 : much better~3 : a little better~4 : no change~5 : a little worse~6 : much worse~7 : very much worse"|Day 29|FAS|||units on a scale||Standard Error|Mean
1426407|NCT01040403|Secondary|Physicians Global Evaluation|"Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29.~The score was evaluated on a 8-points scale :~Poor : 1,2~Fair : 3,4~Good : 5,6~Excellent : 7,8"|Days 1 and 29|FAS|||units on a scale||Standard Error|Mean
1426408|NCT01040403|Secondary|Weekly Mean Number of Puffs of Rescue Medication Used Per Day|Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff).|Weeks 1 and 4|FAS|||number of puffs per day||Standard Error|Mean
1426409|NCT01040403|Secondary|Individual PEF Measurements at Each Time Point on Day 29|Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS|||L/min||Standard Error|Mean
1426410|NCT01040403|Secondary|Individual FVC Measurements at Each Time Point on Day 29|Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
1426411|NCT01040403|Secondary|Individual FEV1 Measurements at Each Time Point on Day 29|Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
1426412|NCT01040403|Secondary|PEF Peak 0-3h Response After the First Dose|Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||L/min||Standard Error|Mean
1426413|NCT01040403|Secondary|PEF Peak 0-3h Response|Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS|||L/min||Standard Error|Mean
1426414|NCT01040403|Secondary|PEF AUC 0-3h Response After the First Dose|Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||L/min||Standard Error|Mean
1426416|NCT01040403|Secondary|FVC Peak 0-3h Response After the First Dose|Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||Litres||Standard Error|Mean
1426417|NCT01040403|Secondary|FVC Peak 0-3h Response|Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
1426418|NCT01040403|Secondary|FVC AUC 0-3h Response After First Dose|Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1|FAS|||Litres||Standard Error|Mean
1426419|NCT01040403|Secondary|FVC AUC 0-3h and FEV1 AUC 0-6h Responses|Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS|||Litres||Standard Error|Mean
1426420|NCT01040403|Secondary|FEV1 Peak 0-3h Response After the First Dose|Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||Litres||Standard Error|Mean
1426421|NCT01040403|Secondary|FEV1 Peak 0-3h Response|Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29|FAS|||Litres||Standard Error|Mean
1426422|NCT01040403|Secondary|FEV1 AUC 0-3h Response After the First Dose|Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1|FAS|||Litres||Standard Deviation|Mean
1426423|NCT01040403|Secondary|FEV1 AUC 0-3h and FEV1 AUC 0-6h Response|Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29|FAS|||Litres||Standard Deviation|Mean
1426424|NCT01040403|Secondary|Trough Forced Vital Capacity (FVC) Response|Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|FAS which included all patients who were dispensed study medication and who provided baseline and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.|||Litres||Standard Error|Mean
1426425|NCT01040403|Primary|Trough FEV1 Response|Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.|Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29|Full Analysis Set (FAS) which comprised all patients in the treated set who provided baseline (study baseline) data and at least 1 on-treatment efficacy value for the primary endpoint after 4 weeks on treatment.|||Litres||Standard Deviation|Mean
1426426|NCT01040351|Secondary|The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .|The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .|18 weeks after embryo transfer|Patients who underwent embryo transfer were included in the final analysis|||participents|||Number
1426427|NCT01040351|Primary|The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle|"The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound~)in a transfer cycle"|5 weeks after embryo transfer|Patients undergoing embryo transfer were included in final analysis|||participents|||Number
1426428|NCT01040260|Primary|Abstinence Rate|Number of participants who abstained from smoking during the 7 day period verified by CO testing|52 weeks||||participants|||Number
1426429|NCT01040208|Secondary|The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.|||participants|||Number
1426430|NCT01040208|Secondary|The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)||12 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.|||participants|||Number
1426431|NCT01040208|Primary|The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.||17 weeks|The treated set (TS) consisted of those patients who were dispensed study medication and who were documented to have taken at least one dose of study medication. All analyses were conducted on the TS.|||participants|||Number
1426432|NCT01040169|Primary|Tooth Hypersensivity Stimuli to Air|Units on a scale using Schiff Cold Air Sensitivity Scale. Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3(The lower the score, the lower the hypersensitivity). 0=No subject response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested.|12 weeks (Final)||||Units on a scale||Standard Deviation|Mean
1426433|NCT01040169|Primary|Tooth Hypersensitity to Touch Stimuli (Tactile)|Units on a scale:Measured with an electronic force sensing probe(Yeaple Probe):10, 20, 30, 40,up to 50 grams of force are applied to hypersensitive tooth until pain is felt. This calibrated instrument measures grams of force applied to each tooth before pain is felt. This data is recorded as the hypersensitivity score. The lower the score, the higher the hypersensitivity.Changes in this score to potentially painful stimulus are determined based on how many grams of force can be applied before the subject reports feeling pain. Grams of force is therefore the unit measurement for sensitivity|12 weeks (Final)||||Units on a scale||Standard Deviation|Mean
1426434|NCT01040130|Secondary|Number of Patients With Notable Increase in QRS Intervals|Number of Patients with notable increase in QRS intervals. Notable QRS interval increase defined as >=10% increase and on-treatment QRS interval > 110 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
1426435|NCT01040130|Secondary|Number of Patients With Notable Increase in PR Intervals|Number of Patients with notable increase in PR intervals. Notable PR interval increase defined as >=25% increase and on-treatment PR interval > 200 ms.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
1426436|NCT01040130|Secondary|Number of Patients With Notable Changes in Heart Rate|Number of Patients with notable changes in heart rate (HR). Notable HR increase defined as >=25% increase and on-treatment HR > 100 bpm; Notable HR decrease defined as >=25% decrease and on-treatment HR < 50 bpm.|Baseline and Week 6|Treated set.|||percentage of participants|||Number
1426437|NCT01040130|Secondary|Change From Baseline to Day 43 in Pulse Rate|Change from Baseline to Day 43 in Pulse rate with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||beats/min||Standard Deviation|Mean
1426438|NCT01040130|Secondary|Change From Baseline to Day 43 in Blood Pressure|Change from Baseline to Day 43 in Blood Pressure with spirometry. Baseline is defined as mean of pre-treatment values at a given time point.|Baseline and Week 6|Treated set. Statistics only include patients with both a baseline and a post dose value.|||mmHg||Standard Deviation|Mean
1426439|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
1426440|NCT01040130|Secondary|Adjusted Mean Peak Expiratory Flow Rate, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters/second||Standard Error|Least Squares Mean
1426441|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426442|NCT01040130|Secondary|Adjusted Mean Forced Vital Capacity, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426443|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426444|NCT01040130|Secondary|Adjusted Mean Forced Expiratory Volume in 1 Second, 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426445|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426446|NCT01040130|Secondary|Adjusted Mean Total Lung Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426447|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 1 Hour Post-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426616|NCT01038752|Secondary|Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes|Insufficient data.|Randomization date|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1426448|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity 30 Minutes Pre-dose After 6 Weeks|Measured using body plethysmography|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426449|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 1 Hour Post-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426450|NCT01040130|Secondary|Adjusted Mean Functional Residual Capacity 30 Minutes Pre-dose After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426451|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at End of Exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
1426452|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Pre-exercise After 6 Weeks|Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
1426453|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at End of Exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426454|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks||6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426455|NCT01040130|Secondary|Adjusted Mean Borg Scale of Breathing Discomfort at Isotime After 6 Weeks|"Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.~Borg scale rates discomfort with breathing at rest, during exercise and at end-exercise on a scale from 0=Nothing at all to 10=Maximal discomfort."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||Scores on a scale||Standard Error|Least Squares Mean
1426456|NCT01040130|Secondary|Adjusted Mean Inspiratory Capacity at Isotime After 6 Weeks|Isotime is defined as the endurance time of the constant work rate exercise test of shortest duration from Baseline visit, and Week 6 of each of the three treatment periods.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint. Only patients who have baseline and at least one post-baseline measurement available were included in the analysis.|||liters||Standard Error|Least Squares Mean
1426457|NCT01040130|Primary|Adjusted Mean Endurance Time After 6 Weeks|Primary endpoint was endurance time during constant work rate ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment. Mixed effects model on log10 transformation data. Adjusted means are back transformed to report as geometric means. Standard errors (SEs) are calculated using the delta method.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and any evaluable post-dose data for the primary endpoint.|||seconds||Standard Error|Geometric Mean
1426458|NCT01040052|Primary|Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine|Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).|Days 0-7 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1426459|NCT01039792|Primary|Clinical Global Impression-Improvement (CGI-I)|PI assesses subject's change using the CGI-I measure. This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement.|8 weeks|comparing placebo vs active B12 subjects|||CGI- Improvement||Standard Deviation|Mean
1426460|NCT01039688|Secondary|Change From Baseline in Temperature||Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|Temperature was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline in temperature will be analyzed as part of the wider clinical program.|||degrees centigrade||Standard Deviation|Mean
1426461|NCT01039688|Secondary|Change From Baseline in Heart Rate||Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|Heart rate was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline will be analyzed as part of the wider clinical program.|||beats per minute||Standard Deviation|Mean
1426617|NCT01038752|Secondary|Pre-treatment bFGF Levels Correlation With Survival.|Insufficient data.|Before first treatment|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1426462|NCT01039688|Secondary|Change From Baseline in FACIT-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status|Months 1, 2, 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426463|NCT01039688|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status|Baseline and Months 1, 2, 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426464|NCT01039688|Secondary|Change From Baseline in MOS-SS at Months 6, 12, 18, and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Months 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426465|NCT01039688|Secondary|Change From Baseline in MOS-SS at Months 1, 2, and 3|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Months 1, 2, and 3|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Error|Least Squares Mean
1426466|NCT01039688|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Months 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426467|NCT01039688|Secondary|Percentage of Participants With Optimal Sleep Assessed Using MOS-SS|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported|Months 1, 2, 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||percentage of participants|||Number
1426468|NCT01039688|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3|Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range: 0-100, higher score=more intensity of attribute.|Baseline and Months 1, 2, and 3|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426469|NCT01039688|Secondary|Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426470|NCT01039688|Secondary|Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
1427159|NCT01033825|Secondary|Percentage of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.|||percentage of subjects|||Number
1426471|NCT01039688|Secondary|Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
1426472|NCT01039688|Secondary|Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
1426473|NCT01039688|Secondary|Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
1426474|NCT01039688|Secondary|Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
1426475|NCT01039688|Secondary|Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
1426476|NCT01039688|Secondary|Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426477|NCT01039688|Secondary|Change From Baseline in Work Productivity and HCRU at Months 3 and 6|RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426478|NCT01039688|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426479|NCT01039688|Secondary|Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
1426480|NCT01039688|Secondary|Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6|RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||hours per day||Standard Deviation|Mean
1426481|NCT01039688|Secondary|Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
1427160|NCT01033825|Secondary|Number of Subjects Experiencing Adverse Events (AEs)||Weeks 0-6|Intent to Treat Population.|||participants|||Number
1426482|NCT01039688|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||days||Standard Deviation|Mean
1426483|NCT01039688|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
1426484|NCT01039688|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||events||Standard Deviation|Mean
1426485|NCT01039688|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Months 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426486|NCT01039688|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Baseline and Months 3 and 6|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426487|NCT01039688|Secondary|Change From Baseline in EQ-5D Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoints for each group, respectively.|||units on a scale||Standard Error|Least Squares Mean
1426488|NCT01039688|Secondary|European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline and Months 3, 6, 12, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426489|NCT01039688|Secondary|Change From Baseline in WLQ Work Loss Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).|Months 3, 6, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a specific timepoint for each treatment group, respectively.|||units on a scale||Standard Error|Least Squares Mean
1426490|NCT01039688|Secondary|WLQ Work Loss Index Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 [no loss] to 100 [complete loss of work]).|Baseline and Months 3, 6, and 12|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1440827|NCT00928694|Primary|Maximum Plasma Concentration (Cmax) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45|||μg/mL||Standard Deviation|Least Squares Mean
1426491|NCT01039688|Secondary|Change From Baseline in WLQ Scores|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Error|Least Squares Mean
1426492|NCT01039688|Secondary|Work Limitation Questionnaire (WLQ) Score|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426493|NCT01039688|Secondary|Change From Baseline in SF-36 Domain Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1426494|NCT01039688|Secondary|SF-36 Domain Scores|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426495|NCT01039688|Secondary|Change From Baseline in SF-36 Physical Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1426496|NCT01039688|Secondary|Change From Baseline in SF-36 Mental Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1426497|NCT01039688|Secondary|SF-36 Physical Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426498|NCT01039688|Secondary|Short Form 36 (SF-36) Mental Component Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426499|NCT01039688|Secondary|Percentage of Participants With at Least 0.5 Improvement in HAQ-DI|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426522|NCT01039688|Secondary|Change From Baseline in Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly."|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Error|Least Squares Mean
1426500|NCT01039688|Secondary|Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426501|NCT01039688|Secondary|Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426502|NCT01039688|Secondary|Change From Baseline in HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1426503|NCT01039688|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426504|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
1426505|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
1426506|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits|ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
1426507|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits|ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
1426508|NCT01039688|Secondary|Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits|ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 3, 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
1426509|NCT01039688|Secondary|Percentage of Participants With an ACR70 Response Sustained at Least 6 Months|ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 6, 9, 12, 15, 18, 21, and 24|FAS, no imputation.|||percentage of participants|||Number
1426618|NCT01038752|Secondary|Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.|Insufficient data.|Day 1 of each cycle; end of treatment visit; at follow-up.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1426510|NCT01039688|Secondary|Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426511|NCT01039688|Secondary|Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426512|NCT01039688|Secondary|Percentage of Participants With DAS28-4(ESR) <2.6|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426513|NCT01039688|Secondary|Percentage of Participants With DAS28-3(CRP) <2.6|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426514|NCT01039688|Secondary|Percentage of Participants With DAS28-4(ESR) ≤3.2|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426515|NCT01039688|Secondary|Percentage of Participants With DAS28-3(CRP) ≤3.2|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1426516|NCT01039688|Secondary|Change From Baseline in DAS28-4(ESR)|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1426517|NCT01039688|Secondary|Change From Baseline in DAS28-3(CRP)|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) <2.6 = remission.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1426518|NCT01039688|Secondary|Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour [mm/hour]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4(ESR) <2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426519|NCT01039688|Secondary|Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP|DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-3(CRP) less than (<)2.6 = remission.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||units on a scale||Standard Deviation|Mean
1426520|NCT01039688|Secondary|Change From Baseline in CRP|Change from Baseline in CRP measured in mg/L.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS|||mg/L||Standard Error|Least Squares Mean
1426521|NCT01039688|Secondary|C-Reactive Protein|CRP measured in milligrams per liter (mg/L)|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mg/L||Standard Deviation|Mean
1426523|NCT01039688|Secondary|Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly."|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Deviation|Mean
1426524|NCT01039688|Secondary|Change From Baseline in Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Error|Least Squares Mean
1426525|NCT01039688|Secondary|Physician Global Assessment of Arthritis|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Deviation|Mean
1426526|NCT01039688|Secondary|Change From Baseline in Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Error|Least Squares Mean
1426527|NCT01039688|Secondary|Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||mm||Standard Deviation|Mean
1426528|NCT01039688|Secondary|Change From Baseline in SJC|Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||swollen joints||Standard Error|Least Squares Mean
1426529|NCT01039688|Secondary|Swollen Joints Count (SJC)|Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||swollen joints||Standard Deviation|Mean
1426530|NCT01039688|Secondary|Change From Baseline in TJC|Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||tender joints||Standard Error|Least Squares Mean
1426531|NCT01039688|Secondary|Tender Joints Count (TJC)|Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||tender joints||Standard Deviation|Mean
1426532|NCT01039688|Secondary|Percentage of Participants Achieving an ACR50 Response|ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI)|||percentage of participants|||Number
1426619|NCT01038752|Secondary|Overall Response Rate (Complete Response + Partial Response) of Participants|Insufficient data|Tumor assessment at every other cycle|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1426533|NCT01039688|Secondary|Percentage of Participants Achieving an ACR20 Response|ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24|FAS (NRI)|||percentage of participants|||Number
1426534|NCT01039688|Secondary|Percentage of Participants Achieving an ACR70 Response|ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.|Months 1, 2, 3, 9, 12, 15, 18, 21, and 24|FAS (NRI)|||percentage of participants|||Number
1426535|NCT01039688|Secondary|Change From Baseline in JSN Scores|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Months 6, 12, and 24|FAS, imputation using LEP|||units on a scale||Standard Error|Least Squares Mean
1426536|NCT01039688|Secondary|Change From Baseline in Erosion Scores|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Months 6, 12, and 24|FAS, imputation using LEP|||units on a scale||Standard Error|Least Squares Mean
1426537|NCT01039688|Secondary|JSN Scores|JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.|Baseline, Months 6, 12, and 24|FAS, imputation using LEP|||score on a scale||Standard Deviation|Mean
1426538|NCT01039688|Secondary|Erosion Scores|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.|Baseline, Months 6, 12, and 24|FAS, imputation using LEP|||units on a scale||Standard Deviation|Mean
1426539|NCT01039688|Secondary|Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24|Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.|Months 6, 12, and 24|FAS (LEP)|||percentage of participants|||Number
1426540|NCT01039688|Secondary|Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.|Months 6, 12, and 24|FAS (LEP); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||percentage of participants|||Number
1426541|NCT01039688|Secondary|Change From Baseline in mTSS Score at Months 12 and 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Months 12 and 24|FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||score on a scale||Standard Error|Least Squares Mean
1426542|NCT01039688|Secondary|mTSS Score at Baseline, Months 12 and 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).|Baseline, Months 12 and 24|FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.|||score on a scale||Standard Deviation|Mean
1426543|NCT01039688|Primary|Change From Baseline in BP Values (mmHg)|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Months 1, 2, 3, 6, 9, 12, 15, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||mmHg||Standard Deviation|Mean
1426544|NCT01039688|Primary|Absolute Blood Pressure (BP) Values (mmHg)|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24|FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.|||mmHg||Standard Deviation|Mean
1426568|NCT01039428|Primary|Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline|Change in serum inorganic phosphorus at the end of treatment from baseline|baseline and end of the chewing treatment during three week treatment period|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
1426545|NCT01039688|Primary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire [HAQ]), and 5) C-reactive protein (CRP).|Month 6|FAS. Missing values due to participant withdrawal were imputed using nonresponder imputation (NRI) method.|||percentage of participants|||Number
1426546|NCT01039688|Primary|Change From Baseline at Month 6 in mTSS|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.|Month 6|FAS, imputation using LEP|||score on a scale||Standard Error|Least Squares Mean
1426547|NCT01039688|Primary|Modified Total Sharp Score (mTSS) at Month 6|mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).|Month 6|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690,550) or MTX (in MTX-naive participants) with a baseline (BL) and at least 1 nonmissing on-study assessment. Missing values due to withdrawal were imputed using linear extrapolation (LEP) of BL/post-BL value before withdrawal.|||score on a scale||Standard Error|Least Squares Mean
1426548|NCT01039675|Secondary|Change From Baseline in Maximum and Minimum Pulse Rate 0 to 6 Hours Post-dose on Days 1, 14, and 28|Pulse rate is defined as the number of heartbeats in a minute (m). A maximum post-Baseline pulse rate was derived as the maximum value recorded at Days 1, 14 and 28. A minimum post-Baseline pulse rate was derived as the minimum value recorded at Days 1, 14 and 28. The maximum and minimum pulse rates were calculated using the 0 to 6 hours (h) post dose measurements on Days 1, 14 and 28, which included pre-dose, and post-dose 15 m, 45 m, 1.5 h, 3 h and 6 h. Maximum and minimum post-Baseline rate were calculated using the nominal 0-6 h post-dose records, and only records collected during the actual 0-7 h post-dose interval were used. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the maximum or minimum pulse rate minus the Baseline value. Analysis performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, Day 14 and Day 28|ITT Population. The overall number of participants presented is the number who provided at least one post-Baseline assessment of 0-6 hours maximum or minimum pulse rate. Those participants who provided data at the indicated time point are represented by n=X, X in the category titles.|||Beats per minutes||Standard Error|Least Squares Mean
1426549|NCT01039675|Secondary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 1 and Day 14|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements on Day 1 and Day 14, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 1 or Day 14 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline, Day 1, and Day 14|ITT Population. All participants with >=1 post-BL assessment are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.|||Beats per minutes||Standard Error|Least Squares Mean
1426550|NCT01039675|Primary|Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28|Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements at Day 28, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 28 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.|Baseline and Day 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >= 1 dose of randomized study medication. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 28.|||Beats per minutes (bpm)||Standard Error|Least Squares Mean
1426551|NCT01039584|Secondary|Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth)|Visit 3: Day 22-31||||participants|||Number
1426552|NCT01039584|Secondary|Clinical Cure|"Clinical cure (clinical success) was defined as follows:~All signs or symptoms with a score of 1 (mild) or 2 (moderate) at Visit 1/Baseline had a score of 0 (absent) at Visit 3/Test-of-Cure, or all signs or symptoms with a score of 3 (severe) at Visit 1/Baseline had a score of 0 (absent) or 1 (mild) at Visit 3/Test-of-Cure~A new sign or symptoms was observed at Visit 3/Test-of-Cure that was not present at entry and was determined by the investigator to not be related to VVC (if related, the subject was considered a failure; if not related, the subject could have been considered a cure)~The subject did not require additional vulvovaginal or systemic antifungal therapy~The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus, such as topical analgesics or corticosteroid products"|Visit 3: Day 22-31|per-protocol|||participants|||Number
1426553|NCT01039584|Primary|The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.|Therapeutic cure is defined as both the mycologically-proven eradication of infection caused by Candida species (mycological cure) and evidence of clinical success (clinical cure)|Visit 3: Day 22-31|per-protocol|||participants|||Number
1426554|NCT01039519|Secondary|Count of Participants With Treatment-Emergent Adverse Events (AEs)|"Treatment-emergent AEs were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death~A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.~Dose modification includes dose delay and dose reduction."|Day 1 up to Week 51|Full analysis set|||participants|||Number
1426555|NCT01039519|Secondary|Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)|PET imaging was completed on selected patients only from one investigative site. Treatment phase PET and biopsy was completed on any day from Cycle 1 Day 2 through Day 10. PET imaging data were analyzed utilizing the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group guidelines [Young H, Eur J Cancer, 1999]. Tumor response was considered a complete response (CR) or a partial response (PR).|Day 2 to Day 10|Participants from one investigative site who provided consent for the PET/CT imaging.|||percentage of participants|||Number
1426556|NCT01039519|Secondary|Kaplan-Meier Estimate of Overall Survival|Overall survival was defined as the time from first dose to death or the date last known alive.|Day 1 up to week 97|Full analysis set|||months||95% Confidence Interval|Median
1426557|NCT01039519|Secondary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|"PFS was defined as the time from the baseline CT scan to disease progression per RECIST or death for any cause. Progressive disease (PD) was defined as~at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or~the appearance of 1 or more new lesions or~the unequivocal progression of existing nontarget lesions"|Day 1 up to Week 47|Full analysis set|||months||95% Confidence Interval|Median
1426558|NCT01039519|Secondary|Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0|"Objective response included participants whose best response with confirmation was a complete response (CR) or partial response (PR) from first dose until progression or end of study.~CR: disappearance of all target lesions and non-target lesions and no new lesions~PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set|||percentage of participants|||Number
1426559|NCT01039519|Primary|Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|"Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks.~CR: disappearance of all target lesions and non-target lesions and no new lesions~PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions"|Week 16 up to Week 47|Full analysis set which included participants receiving at least one dose of study medication.|||percentage of participants|||Number
1426560|NCT01039428|Secondary|Serum Intact Fibroblast Growth Factor (FGF) 23 Level|Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||log10(pg/mL)||Standard Deviation|Mean
1426561|NCT01039428|Secondary|Serum Intact Parathyroid Hormone (PTH) Level|Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||pg/mL||Standard Deviation|Mean
1426562|NCT01039428|Secondary|Ca×P|Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/mL*mg/mL||Standard Deviation|Mean
1426563|NCT01039428|Secondary|Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL])|Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
1426564|NCT01039428|Secondary|Salivary Inorganic Phosphorus Level|Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
1426565|NCT01039428|Secondary|Serum Inorganic Phosphorus Level|Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).|week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||mg/dL||Standard Deviation|Mean
1426566|NCT01039428|Secondary|Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P＜5.5 mg/dL at Week 3||week 3|Per Protocol Set included randomized participants who completed the entire clinical trial and were counted towards the final results. The endpoint was analyzed only for those participants who had data for this outcome measure.|||participants|||Number
1426567|NCT01039428|Secondary|Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL||baseline and end of the treatment|Full Analysis Set included all randomized participants who received at least one dose of study product. The endpoint was analyzed only for those participants who had data for this outcome measure.|||participants|||Number
1426569|NCT01039376|Secondary|Plasma Half-life (t1/2) of Ofatumumab|The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
1426570|NCT01039376|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.|Day 1 Month 1 ( Cycle 1) through Month 25 ( Cycle 13)|PK Population. Only those participants available at the indicated time points were analyzed.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1426571|NCT01039376|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of the drug exposure over time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||micrograms*hour per mL (µg*hour/mL)||Geometric Coefficient of Variation|Geometric Mean
1426572|NCT01039376|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|PK Population. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||millileters per hour (mL/hour)||Geometric Coefficient of Variation|Geometric Mean
1426573|NCT01039376|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.|Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)|Pharmacokinetic (PK) Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed. Only those participants available at the indicated time points (indicated by n=X in the category titles) were analyzed.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1426574|NCT01039376|Secondary|Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers|Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=CY G.|From Baseline until the end of the study (up to 84 months)|ITT Population|||Participants|||Number
1426575|NCT01039376|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and every two months from Month 3 until Month 25 and at every follow-up visit (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Cells per microliter||Standard Deviation|Mean
1426576|NCT01039376|Secondary|Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.|From randomization until the end of the study (up to 84 months)|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Number
1426577|NCT01039376|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value. Immunoglobulins were measured at the following time points: Baseline (BL) and Cycle (C) 2 Week (W) 9/Month (M) 3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL) were presented.|Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 24 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||grams per liter||Standard Deviation|Mean
1426609|NCT01038869|Primary|Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)|IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement.|Baseline to 16 weeks|Per protocol|||percentage of participants|||Number
1426610|NCT01038856|Secondary|Decrease of Mutant JAK2V617F Allele Burden||every 2 months until end of treatment and 12 months after end of treatment|did not achieve hematological response|||Participants|||Count of Participants
1426578|NCT01039376|Secondary|Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result|All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.|Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.|||Participants|||Number
1426579|NCT01039376|Secondary|Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From randomization until the end of the study (up to 24 months)|Safety Population|||Participants|||Number
1426580|NCT01039376|Secondary|Number of Participants Who Received at Least One Transfusion During the Study|Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.|From randomization until the end of the study (up to 24 months)|Safety Population|||Participants|||Number
1426581|NCT01039376|Secondary|Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points|Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia [low hemoglobin count], neutropenia [low neutrophil count], and thrombocytopenia [low platelet count]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death). Assessment was at the following time points: Screening, C1 W1/M1, C1 W2/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C5 unscheduled, C6 W41/M11, C6 unscheduled, C7 W49/M13, C8 W57/M15, C8 unscheduled, C9 W65/M17, C10 W73/M19, C11 W81/M21,C11 unscheduled, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M FU and WDL.|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months)|Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
1426582|NCT01039376|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 24 months for non-serious AEs and 84 months for SAEs)|Safety Population|||Participants|||Number
1426583|NCT01039376|Secondary|Number of Participants With Grade 3 and Above Adverse Event of Infection|Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).|From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 84 months)|Safety Population: all participants who were randomized in the study and analyses were done based on the treatment the participant received regardless of how they were randomized.|||Participants|||Number
1426584|NCT01039376|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points|Par. with the indicated constitutional or B-symptoms (night sweats [without signs of infection]; unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of > 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of par. with no night sweats, no weight loss, no fever and no extreme fatigue were summarized and compared to the proportion of par. with >= 1 of the following: night sweats, weight loss, fever or extreme fatigue. The proportions were compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). B-symptoms were assessed at the following time points: Screening, C1 W1/M1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M, 6M, 9M, 12M, 15M, 18M, 21M FU and WDL.|From Screening until the end of the study (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Participants|||Number
1426585|NCT01039376|Secondary|Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points|Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). The proportion of participants with improvement was compared between treatment groups with the Cochran-Mantel-Haenszel test adjusting for stratification factors (response at entry, number of prior treatments and type of prior treatment). Improvement in ECOG performance status was measured at the available time points that have data: Cycle (C) 1 Week (W) 2/Month (M) 1, C2 W9/M3, C3 W17/M5, C4 W25/M7, C5 W33/M9, C6 W41/M11, C7 W49/M13, C8 W57/M15, C9 W65/M17, C10 W73/M19, C11 W81/M21, C12 W89/M23, C13 W97/M25, 3M Follow-up (FU), 6M FU, 9M FU, 12M FU, 15M FU, 18M FU, 21M FU and Withdrawal (WDL).|From randomization until the end of the study (up to 84 months)|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1426611|NCT01038856|Secondary|Improvement in Splenomegaly Size||4 months, end of treatment and 12 months end of treatment|no improvement in spleen size|||Participants|||Count of Participants
1426586|NCT01039376|Secondary|Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.|From randomization until the end of the study (up to 84 months)|ITT Population|||Scores on a scale||Standard Deviation|Mean
1426587|NCT01039376|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from poor (worse quality of life) to excellent (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA."|From randomization until the end of the study (up to 84 months)|ITT Population|||Scores on a scale||Standard Deviation|Mean
1426588|NCT01039376|Secondary|Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) – and single-item scales (social activities [Social Problems (SP) Scale] and future health worries [Future Health (FH) Scale]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).|From randomization until the end of the study (up to 84 months)|ITT Population|||Scores on a scale||Standard Deviation|Mean
1426589|NCT01039376|Secondary|Time to Progression After Next-line Therapy|Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.|From randomization until progression or death (up to 84 months)|ITT Population. Only participants who received next-line therapy and who also had PD prior to next line therapy were analysed. Participants who died prior to next-line therapy were also included for analysis.|||Months||95% Confidence Interval|Median
1426590|NCT01039376|Secondary|Progression-free Survival After Next-line Therapy|Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.|From randomization until progression or death (up to 84 months)|ITT Population. Only participants who received next-line therapy and subjects who died prior to receiving next-line therapy were analyzed.|||Months||95% Confidence Interval|Median
1426591|NCT01039376|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.|From randomization until the end of the study (up to 84 months)|ITT Population|||Months||95% Confidence Interval|Median
1426592|NCT01039376|Secondary|Number of Participants With Improvement in Response From Baseline|Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.|From Baseline until the end of the study (up to 24 months)|ITT Population. Only participants who had PR at study entry were analyzed.|||Participants|||Number
1426593|NCT01039376|Secondary|Overall Survival|Overall survival is defined as time from randomization to date of death.|From randomization until death (up to 84 months)|ITT Population|||Months||95% Confidence Interval|Median
1426594|NCT01039376|Primary|Progression-free Survival, as Assessed by the Independent Review Committee (IRC)|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 84 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.|||Months||95% Confidence Interval|Median
1426612|NCT01038856|Secondary|Toxicity||First assessment at day 15, subsequent assessments at 28 day intervals for an average of 1 year||||Participants|||Count of Participants
1426613|NCT01038856|Primary|Overall Response Rate to Include Complete Hematological Response, Complete Molecular Response, Partial Hematological Response, and Minimal Hematological Response||Day 15||||participants|||Number
1426595|NCT01039376|Primary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.|From randomization until progression or death (up to 84 months)|Intent-to-Treat (ITT) Population: all participants who were randomized in the study.|||Months||95% Confidence Interval|Median
1426596|NCT01039207|Other Pre-specified|Circulating Levels of Markers of Angiogenesis|Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).|Up to 1 day prior to course 2|||||||
1426597|NCT01039207|Other Pre-specified|Circulating Levels of HGF/Scatter Factor (SF)|Exploratory analyses will be conducted to assess the possible effects of the study regimen on the biomarkers of interest as well as associations between the biomarkers and clinical outcome (such as PFS and OS).|Up to 1 day prior to course 2|||||||
1426598|NCT01039207|Other Pre-specified|Biomarker Panel From Tumor Tissue|A panel of biomarkers from fixed and embedded tumor tissue will be tested for association with measures of response to treatment including PFS and OS.|Baseline|||||||
1426599|NCT01039207|Secondary|Duration of Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.|Eligible and treated patients|||months||90% Confidence Interval|Median
1426600|NCT01039207|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients. Measure type = The first quartile of the distribution since follow-up time is insufficient to obtain adequate median estimates.|||months||90% Confidence Interval|Number
1426601|NCT01039207|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment|Eligible and treated patients.|||participants|||Number
1426602|NCT01039207|Primary|Progression-free Survival > 6 Months Using RECIST 1.0|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; up to 6 months.|Eligible and treated patients|||participants|||Number
1426603|NCT01039207|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle during treatment then every 3 months thereafter until disease progression is confirmed; also repeat at any time if clinically indicated up to 5 years.|Eligible and treated patients.|||participants|||Number
1426604|NCT01038921|Primary|Metabolic Syndrome Components||3 years||||mmHg||Standard Deviation|Mean
1426605|NCT01038869|Secondary|Tolerability Assessments as Measured by the Number of Participants With Side Effects|Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus|16 weeks|per protocol|||participants|||Number
1426606|NCT01038869|Secondary|Percentage Change in Total Lesion Counts|Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones).|Baseline to 16 weeks|per protocol|||percentage of total lesion count||Standard Deviation|Mean
1426607|NCT01038869|Secondary|Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution|The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50%|Baseline to 16 weeks|per protocol|||percentage of participants|||Number
1426608|NCT01038869|Secondary|Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)|IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement|Baseline to16 weeks|per protocol|||percentage of participants|||Number
1426621|NCT01038752|Primary|Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria|Insufficient data|Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.|Because 6 of 14 participants were lost to follow up before progression, analysis was not performed.||||||
1426622|NCT01038713|Secondary|Assess Rate of Acute Cholecystitis Associated With Each Type of Stent||time from stent placement to 500 days||||Participants|||Number
1426623|NCT01038713|Secondary|Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents|Total number of days in which neoadjuvant therapy was delayed due to stent related issues|Time from stent placement to 500 days||||Days|||Number
1426624|NCT01038713|Secondary|Determine the Days of Hospitalization Following Stent Placement|Number of total days of hospitalization for all patients in each group|From stent placement up to 500 days post stent||||Days|||Number
1426625|NCT01038713|Secondary|Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.||Costs measured up to 500 days||||United States Dollars|||Number
1426626|NCT01038713|Primary|Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction.|Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement|Time of stent occlusion, attempted surgical resection or patient death to 300 days||||participants|||Number
1426627|NCT01038635|Secondary|Overall Response: Number of Participants With CR or CRi Response|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months||||participants|||Number
1426628|NCT01038635|Secondary|Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia|Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.|6 months||||percentage of participants|||Number
1426629|NCT01038635|Primary|Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)|DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.|3-8 week cycles, up to 24 weeks||||participants|||Number
1426630|NCT01038609|Secondary|Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L.|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
1426631|NCT01038609|Secondary|Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria|Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate <10 respirations per minute (rpm) (low) or >24 rpm (high).|At specified intervals from Screening through 7 days after first dose of study drug|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
1426632|NCT01038609|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
1426633|NCT01038609|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||minutes||95% Confidence Interval|Median
1428244|NCT01023958|Secondary|Duration of Overall Response|The duration of overall response is measured from the time of first response (CR or PR) to progression or death whichever occurs first.|From the time of first response (CR or PR) to progression or death, up to 2 years|TS|||Weeks||Full Range|Median
1426634|NCT01038609|Secondary|Participant's Global Assessment of Study Drug|The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||participants|||Number
1426635|NCT01038609|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||scores on a scale||Standard Error|Least Squares Mean
1426636|NCT01038609|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 48 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).|||scores on a scale||Standard Error|Least Squares Mean
1426637|NCT01038336|Secondary|Change in Cues to Action Score|Cues to action is a construct from the Health Belief Model defined as external influences that promote a health behavior (e.g. symptoms, media communications, or information from a healthcare provider). In the current study it refers to prompts from others about protecting hearing. Cues to action was assessed with 2 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater cues to action, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Cues to action was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating more Cues to action having been received at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
1426638|NCT01038336|Secondary|Change in Perceived Self-efficacy Score|Perceived Self-efficacy is a construct from the Health Belief Model defined as an individual's assessment of his/her ability to successfully adopt a health behavior. In the current study it assesses the extent to which the individual believes that he/she has the knowledge and abilities to protect hearing. Perceived Self-efficacy was assessed with 4 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived self-efficacy, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Self-efficacy was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived self-efficacy at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
1426639|NCT01038336|Secondary|Change in Perceived Barriers Score|Perceived Barriers is a construct from the Health Belief Model defined as an individual's assessment of the influences that discourage adoption of a health behavior. In the current study it assesses the extent to which the individual perceives few negative influences to protecting hearing. Perceived Barriers was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating fewer perceived barriers, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Barriers was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating fewer perceived barriers at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
1426640|NCT01038336|Secondary|Change in Perceived Benefit Score|Perceived Benefit is a construct from the Health Belief Model defined as an individual's assessment of the positive consequences of adopting a health behavior. In the present study that is the belief that hearing well is important. Perceived Benefit was assessed with 7 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived benefit, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived benefit was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived benefit at follow-up.|Baseline and 1 month||||units on scale||Standard Deviation|Mean
1426641|NCT01038336|Secondary|Change in Perceived Severity Score|Perceived Severity is a construct from the Health Belief Model defined as an individual's assessment of the seriousness of the consequences of a condition if it is acquired. In the current study it assesses the extent to which the individual believes that a hearing loss would have negative consequences. Perceived Severity was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived severity, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Severity was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived severity at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
1426673|NCT01037218|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
1426642|NCT01038336|Secondary|Change in Perceived Susceptibility Score|Perceived Susceptibility is a construct from the Health Belief Model defined as an individual's assessment of the risk of acquiring a condition. In the current study it assesses the extent to which the individual feels vulnerable to hearing loss. Perceived Susceptibility was assessed with 5 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived susceptibility, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Susceptibility was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived susceptibility at follow-up.|Baseline and 1 month||||Units on a scale||Standard Deviation|Mean
1426643|NCT01038336|Secondary|Knowledge About Hearing Conservation Scale|Knowledge about hearing conservation was assessed with 16 items in the the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). It is a validated questionnaire that assesses knowledge about and attitudes toward hearing and hearing loss prevention. The Knowledge scale is scored as a percent correct, with a higher score indicating more knowledge. Data presented are for change in knowledge between baseline and 1-month follow-up computed such that a higher score indicates greater increase in knowledge.|Baseline and 1 month||||percent of correct answers||Standard Deviation|Mean
1426644|NCT01038336|Primary|Percentage of Time Spent at Sound Levels >80 Decibels|Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels >80 decibels|1 month||||percentage of time||Standard Deviation|Mean
1426645|NCT01038323|Secondary|Identification of Group Assignment|Subjects identifying group assignment correctly|week 21|Information not captured (unfortunately)|||participants|||Number
1426646|NCT01038323|Secondary|Change in Evoked Pain Scores|0 to 20 pain scale, with higher pain score representing greater sensitivity to pressure pain stimuli|Baseline and Week 21 clinic visits||||units on a scale||Standard Error|Mean
1426647|NCT01038323|Primary|Change in Weekly Average Pain Intensity|Change in weekly average pain intensity score from baseline to week 21 (scale from -10 to +10; the more negative the value, the better in terms of pain reduction)|Baseline and Week 21clinic visits||||units on a scale||Standard Error|Mean
1426648|NCT01038128|Primary|Brown Assessments of Belief Scale|The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.|Baseline to 12 weeks|This scale was only administered to participants with Body Dysmorphic Disorder. No participants with BDD completed the Baseline Visit and, therefore, no results were available to analyze.||||||
1426649|NCT01038128|Primary|Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale|The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||units on a scale||Standard Deviation|Mean
1426650|NCT01038128|Primary|Clinical Global Impression Scale|Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||units on a scale||Standard Deviation|Mean
1426651|NCT01038128|Primary|Ratings of Eating Pathology|"Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number 777 was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes."|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||units on a scale||Standard Deviation|Mean
1426652|NCT01038128|Primary|Number of Binge Eating and Self-induced Vomiting Episodes|Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.|Baseline to 12 weeks|One subject completed. The remaining two subjects' last observation was carried forward.|||number of episodes||Standard Deviation|Mean
1426653|NCT01037452|Secondary|Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.||1 day||||participants|||Number
1426654|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day||||millimeters||95% Confidence Interval|Mean
1426655|NCT01037452|Secondary|Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals|"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe"|1 day||||millimeters||95% Confidence Interval|Mean
1426656|NCT01037452|Primary|Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal|Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment.|1 day||||participants||95% Confidence Interval|Number
1426657|NCT01037309|Primary|Determine the Pharmacokinetics of PRO044||During the 5 weeks of treatment and during the 13 weeks after treatment|||||||
1426658|NCT01037309|Primary|Safety and Tolerability of PRO044|number of subjects with 1 or more treatment emergent adverse events following SC or IV PRO044|During the 5 weeks of treatment and during the 13 weeks after treatment||||participants|||Number
1426659|NCT01037309|Primary|Increase in Dystrophin Expression in the Muscle Biopsies by Immunofluorescence Analyses of Cross-sections and by Western Blot Analyses of Total Protein Extracts||Within 13 weeks after 5 weeks of treatment|For some participants it was not possible to determine dystrophin expression in muscle biopsy|||participants|||Number
1426720|NCT01036763|Primary|Assessment of Tolerability According to Patient|Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks||||Participants|||Number
1426660|NCT01037244|Primary|Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
1426661|NCT01037244|Secondary|Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT|Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
1426662|NCT01037244|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
1426663|NCT01037244|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage of Yes Responders||95% Confidence Interval|Least Squares Mean
1426664|NCT01037244|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
1426665|NCT01037244|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
1426666|NCT01037244|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0 (poor) - 5/(good) scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
1426667|NCT01037244|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
1426668|NCT01037244|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population|EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use? How satisfied w/how quickly it works? How long it lasts? How confident made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline to Week 12|mITT Population|||units on a scale||95% Confidence Interval|Least Squares Mean
1426669|NCT01037244|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)|Baseline to Week 12|mITT Population|||units on a scale||95% Confidence Interval|Least Squares Mean
1426670|NCT01037244|Secondary|Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population||Week 12|mITT Population|||participants|||Number
1426671|NCT01037244|Primary|Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.|Baseline and Weeks 1 - 12|Modified Intent-to-Treat (mITT)|||Percentage Yes Responders||95% Confidence Interval|Least Squares Mean
1426672|NCT01037244|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)|||units on a scale||95% Confidence Interval|Least Squares Mean
1426721|NCT01036763|Primary|Assessment of Efficacy According to Patient|patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)|6 - 12 weeks||||Participants|||Number
1426674|NCT01037218|Secondary|Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT|SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
1426675|NCT01037218|Secondary|Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT|SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage Yes Responses||95% Confidence Interval|Least Squares Mean
1426676|NCT01037218|Secondary|Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population|PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity|Baseline and Week 12|mITT|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1426677|NCT01037218|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT|EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1426678|NCT01037218|Secondary|Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population|While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)|Week 12|mITT|||Yes Responders|||Number
1426679|NCT01037218|Secondary|Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1426680|NCT01037218|Secondary|Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1426681|NCT01037218|Secondary|Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1426682|NCT01037218|Secondary|Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF|Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1426683|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage of Yes Responses||95% Confidence Interval|Least Squares Mean
1426684|NCT01037218|Primary|Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT|Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.|Baseline and Weeks 1-12|mITT|||Percentage of Yes Reponses||95% Confidence Interval|Least Squares Mean
1426685|NCT01037218|Primary|Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)|Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?|Baseline and Week 12|mITT, LOCF|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1426686|NCT01037192|Secondary|Microbiological Efficacy|Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.|5 days||||participants|||Number
1426687|NCT01037192|Primary|Clinical Efficacy|Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (> 15%) in leukocytes.|5 days||||participants|Participants||Number
1426722|NCT01036763|Primary|Assessment of Tolerability According to Physician|Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks||||Participants|||Number
1426688|NCT01037127|Secondary|Number of Participants With Tumor Progression|Tumor progression was assessed as disease progression (DP), defined as at least a 20 percent increase in the sum of diameters of target lesions (representative of all involved organs), taking as reference the smallest sum on study; unequivocal progression of non-target lesions; or the appearance of a new lesion. Because melanoma often progresses to the brain/central nervous system (CNS) and this study enrolled approximately 20% participants with prior brain metastases, tumor progression in the brain/CNS was summarized. Paticipants could have been included in more than one category.|Baseline (Day 1) until tumor progression (up to approximately 57 weeks)|All Treated Population|||Participants|||Number
1426689|NCT01037127|Secondary|Number of Participants Who Survived Until 6 Months, 12 Months and 24 Months From Baseline|Overall survival (defined as the time from the treatment start date until death due to any cause) data data are presented as the number of participants who were alive 6 months, 12 months and 24 months after Baseline. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Month 6, Month 12 and Month 24|All Treated Population|||Participants|||Number
1426690|NCT01037127|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until death due to any cause (up to 134 weeks)|All Treated Population|||Months||95% Confidence Interval|Median
1426691|NCT01037127|Secondary|PFS in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|PFS was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Per RECIST version 1.1, PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred earliest. Brain metastasis is a cancer that has spread to the brain from another location of the body.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because this subgroup was stopped for futility and nearly all the participants progressed before 4 months.|||Months||95% Confidence Interval|Median
1426692|NCT01037127|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval between the treatment start date and the earliest date of disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause, whichever occurred first. Participants who had not progressed or died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|Baseline (Day 1) until the time of disease progression or death due to any cause (up to approximately 57 weeks)|All Treated Population|||Months||95% Confidence Interval|Median
1426693|NCT01037127|Secondary|Duration of Tumor Response|Duration of tumor response is defined as the time from the first documented evidence of a CR or PR to disease progression (at least a 20 percent increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; unequivocal progression of non-target lesions, or the appearance of a new lesion) or death due to any cause. No participants who were previously treated with BRAF inhibitors had a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions; thus, no duration of response data can be presented.|From the time of the first documented evidence of a confirmed CR or PR until disease progression or death due to any cause (up to approximately 40 weeks)|All Treated Population. Only those participants who had a confirmed CR or PR were analyzed for duration of response.|||Months||95% Confidence Interval|Median
1426694|NCT01037127|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. AE and serious AE (SAE) data were collected from the start of the investigational product and continued until the End of Treatment Visit. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study medication until 28 days after the last dose (up to 477 days)|All Treated Population|||Participants|||Number
1426695|NCT01037127|Secondary|Mean Plasma Concentrations|Human plasma samples were analyzed for trametinib using a validated analytical method.|Day 15, pre-dose, 0.5-2 hours (hrs) post-dose, 2-4 hrs post-dose, and 4-8 hrs post-dose; Week 4, pre-dose; Week 8, pre-dose; Week 12, pre-dose|Pharmacokinetic (PK) Population: all participants in the All Treated Population for whom PK samples were obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
1426696|NCT01037127|Primary|Number of Participants With Best Unconfirmed Response at the Time of the Interim Analysis (Week 8)|An interim analysis was performed using data collected approximately 12 and 13 weeks after the 30th participant was enrolled in the prior BRAF inhibitor and prior standard therapy groups, respectively. The best unconfirmed response by the investigator per RECIST version 1.1 was assessed. The study design permitted stopping the study for futility if <3 best confirmed responses were observed in the first 30 participants of each treatment arm after completing the first post-dose assessment at Week 8. Best response was measured as either a CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters, or a PR, defined as at least a 30% decrease in the sum of the diameters of target lesions.|Week 8|All Treated Population|||Participants|||Number
1426723|NCT01036763|Primary|Assessment of Efficacy According to Physician|Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined|6 - 12 weeks||||Participants|||Number
1429735|NCT01012167|Secondary|Laboratory Measures - Potassium|Potassium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
1426697|NCT01037127|Primary|Number of Participants With Best Confirmed Response in the Indicated Subgroups of Participants Previously Treated With Standard Therapy But Not BRAF Inhibitors|The number of participants with best confirmed response was analyzed for the following subgroups of participants previously treated with standard therapy but not BRAF inhibitors: (1) participants with prior (before the start of this study) brain metastases (mets); (2) participants without prior brain mets; (3) participants with BRAF mutation V600E; (4) participants with BRAF mutation V600E and no prior brain mets; and (5) participants with BRAF mutation V600K. Objective response was assessed per RECIST version 1.1. Objective response was measured either as CR, defined as the disappearance of all target lesions and pathological lymph nodes <10 mm, or PR, defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met. Brain metastasis is a cancer that has spread to the brain from another location of the body.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed CR or PR (up to approximately 25 weeks)|All Treated Population. A single participant could have been included in more than one subgroup. Subgroup analysis was not conducted in participants previously treated with BRAF inhibitors because there were no CRs or PRs among these participants.|||Participants|||Number
1426698|NCT01037127|Primary|Number of Participants With Best Confirmed Response|Best confirmed response was assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Best response was measured either as a complete response (CR), defined as the disappearance of all target lesions and pathological lymph nodes <10 millimeters (mm), or a partial response (PR), defined as at least a 30% decrease in the sum of the diameters of target lesions. To be assigned a status of confirmed CR or PR, a confirmatory disease assessment was required no less than 28 days after the criteria for response were first met.|From Baseline (Day 1) until the time of the first documented evidence of a confirmed complete response or partial response (up to approximately 25 weeks)|All Treated Population: all participants who received at least one dose of investigational product|||Participants|||Number
1426699|NCT01037114|Secondary|Number of Subjects Reporting SAEs Related to Study Participation or a Concurrent GSK Medication.|An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Up to Year 20.|The LT Total cohort included all subjects who returned at each annual time point and who belonged to the Total cohort in the primary study.|||Subjects|||Number
1426700|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"One subject received a challenge dose of Havrix at Year 18 and another at Year 20.~Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity."|During the 31-day (Days 0-30) follow-up period after the Havrix™ challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.|||subjects|||Number
1426701|NCT01037114|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|"Only 1 subject received a challenge dose at Year 16 of Engerix-B.~An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|During the 31-day (Days 0-30) follow-up period after the Engerix™-B challenge dose.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.|||Subjects|||Number
1426702|NCT01037114|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"At Year 16, 1 subject was administered a challenge dose of Engerix™-B and at Y18 and Y20, 2 subjects were administered a challenge dose of Havrix™.~An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|31 days (Days 0-30) after the challenge dose of Engerix-B and Havrix.|The analysis was performed on the long-term total cohort which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine or Havrix.|||Subjects|||Number
1426703|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Havrix|"Anti-HAV anamnestic response to the challenge dose was defined as:~Anti-HAV antibody concentrations ≥ 15 mIU/mL at one month post-challenge dose, in subjects seronegative at the pre-challenge time point.~At least a 2-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in subjects having anti-HAV antibody concentrations ≥ 100 mIU/mL at the pre-challenge time point.~Or at least a 4-fold increase in anti-HAV antibody concentrations one month after the challenge dose, in seropositive subjects having anti-HAV antibody concentrations < 100 mIU/mL at the pre-challenge time-point."|30 days after the challenge dose of Havrix|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.|||subjects|||Number
1426704|NCT01037114|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose of Engerix-B|"At Year 16 only 1 subject was eligible for the challenge dose of Engerix-B.~Anti-HBs anamnestic response to the challenge dose was defined as:~Anti-HBs antibody concentrations >= 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time point.~At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time point."|30 days after the challenge dose of Engerix-B|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.|||Subjects|||Number
1440828|NCT00928694|Primary|Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid||Predose and up to 168 hours postdose|Healthy Male and Female subjects Aged 18 to 45|||μg·hr/mL||Standard Deviation|Least Squares Mean
1426705|NCT01037114|Secondary|Anti-HAV Concentrations After the Challenge Dose of Havrix.|Concentration was given in mIU/mL. Only 2 subjects were eligible for the challenge dose of Havrix, one at Year 18 and another at Year 20 time point. Therefore the values for these subject are given without a measure of dispersion.|Before, 14 days and one month (30 days) after the challenge dose of Havrix|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Havrix vaccine because their anti-HAV antibody concentrations were < 15 mIU/mL.|||mIU/mL|||Number
1426706|NCT01037114|Secondary|Anti-HBs Concentrations After the Challenge Dose of Engerix-B|"Concentration was given in mIU/mL.~Only 1 subject was eligible for the challenge dose of Engerix-B at the Year 16 time point. Therefore the values for this subject are given without a measure of dispersion."|Before, 14 days and one month (30 days) after the challenge dose of Engerix-B|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at the blood sampling time point for whom results were available and who received a challenge dose of Engerix-B vaccine because their anti-HBs antibody concentrations were < 10 mIU/mL.|||mIU/mL|||Number
1426707|NCT01037114|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.|||mIU/mL||95% Confidence Interval|Geometric Mean
1426708|NCT01037114|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL)|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the long-term according-to-protocol (LT ATP) cohort for immunogenicity which included subjects who returned at a particular blood sampling time point, who were included in the ATP analysis for the primary study and who did not receive hepatitis A or B vaccination that was not specified in the protocol.|||Subjects|||Number
1426709|NCT01037088|Secondary|Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis|The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). VAS Pain Intensity was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).|baseline to six hours||||units on a scale||Standard Deviation|Mean
1426710|NCT01037088|Primary|Participants With 30% or Greater Reduction in Pain Intensity|The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.|baseline to six hours|This was a cross over study. Ten of the 38 subjects who were exposed to placebo had a 30% reduction in pain intensity as compared to 21 of the 37 exposed to the low dose and 22 of the 36 receiving the medium dose of cannabis.|||percentage of participants||95% Confidence Interval|Number
1426711|NCT01036802|Secondary|Major and Minor Bleeding Complications|We evaluated the safety of warfarin by evaluating for major and minor bleeding complications in study subjects|Evaluations were obtained at Screening, and at Months 3, 6, 9, and 12||||participants|||Number
1426712|NCT01036802|Secondary|All-cause Mortality|We assessed the effect of warfarin on mortality in the study subjects|Assessment was obtained until completion of study at 12 months||||participants|||Number
1426713|NCT01036802|Secondary|Endothelial Activation|We assessed the effect of warfarin on plasma measures of endothelial activation (soluble vascular cell adhesion molecule-1)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|As the number of subjects studied were very few, requiring discontinuation of the study, evaluation of endothelial activation was not performed.||||||
1426714|NCT01036802|Secondary|Platelet Activation|We evaluated the effect of anticoagulation with warfarin on platelet activation assessed by measuring plasma levels of soluble CD40 ligand|Measurements were obtained at Screening, Prior to Run-in, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.||||||
1426715|NCT01036802|Secondary|Thrombin Generation|We evaluated the effect of warfarin on a plasma measure of thrombin generation (thrombin-antithrombin complex)|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12|No analysis was performed due to the early termination of the study and the very small number of participating subjects.||||||
1426716|NCT01036802|Secondary|6-minute Walk Test|We evaluated the distance walked over 6 minutes. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, Months 3, 6, 9, and 12||||feet||Full Range|Mean
1426717|NCT01036802|Primary|Effect of Anticoagulation on Pulmonary Artery Systolic Pressure Was Obtained by Doppler Echocardiography|We determined the effect of anticoagulation with warfarin on estimated pulmonary artery systolic pressure obtained by Doppler echocardiography. The presented data are average values for the study subjects in the treatment group. When data was missing, the previous value was carried forward.|Measurements were obtained at Screening, and at Months 3, 6, 9, and 12||||mm Hg||Full Range|Mean
1426718|NCT01036763|Secondary|Physician's Global Evaluation at Visit 2|Physician’s global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6–12 weeks of treatment with Spiriva.|after 6 - 12 weeks||||Participants|||Number
1426719|NCT01036763|Secondary|Physician's Global Evaluation at Visit 1|Physician’s global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores “Poor (1, 2)”, “Satisfactory (3, 4)”, “Good (5, 6)” and “Excellent (7, 8)” prior to treatment with Spiriva.|0 weeks||||Participants|||Number
1440932|NCT00928187|Secondary|Number of Patients With WHO Stage 3 and 4 HIV Related Events|patients having a diagnosis of HIV related event classified as stage 3 or 4|between baseline and 48 weeks|ITT|||participants|||Number
1426724|NCT01036763|Primary|Success of Treatment With Tiotropium According to Physician's Assessment|Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful|6 - 12 weeks|All patients who were documented to have taken at least one dose of Spiriva®18 Microgram/Spiriva® Respimat® and had COPD requiring long-acting anticholinergics|||Participants|||Number
1426725|NCT01036724|Secondary|Total Procedure Time||Total Duration of the Procedure||||minutes||Full Range|Median
1426726|NCT01036724|Primary|Total Fluoroscopy Time|The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures.|Throughout the Total Duration of the Procedure||||minutes||Full Range|Median
1426727|NCT01036529|Primary|Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment||3, 6- and 12- months post-index procedure||||proportion of participants|||Number
1426728|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||52 weeks minus baseline||||mL/min/1.73m^2||Standard Deviation|Mean
1426729|NCT01036490|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR)||12 weeks minus baseline||||mL/min/1.73m^2||Standard Deviation|Mean
1426730|NCT01036490|Secondary|Change in Albuminuria||52 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
1426731|NCT01036490|Secondary|Change in Albuminuria||12 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
1426732|NCT01036490|Primary|Change in Proteinuria||52 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
1426733|NCT01036490|Primary|Change in Proteinuria||12 weeks minus baseline||||mg/g creatinine||Inter-Quartile Range|Median
1426734|NCT01036438|Secondary|Change in Inflammatory Signs|Change in inflammatory signs|4 weeks|||||||
1426735|NCT01036438|Primary|Efficacy Will be Defined as Absolute Wound Size Reduction.|Efficacy will be defined as absolute wound size reduction.|8 weeks||||cm2||Standard Deviation|Mean
1426736|NCT01036321|Secondary|Biomarkers of Disease Progression - Total Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||ng/dL||Full Range|Median
1426737|NCT01036321|Secondary|Biomarkers of Disease Progression - Sex Hormone-binding Globulin (SHBG)|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||nmol/L||Full Range|Median
1426738|NCT01036321|Secondary|Biomarkers of Disease Progression - IGF-1|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||ng/mL||Full Range|Median
1426739|NCT01036321|Secondary|Biomarkers of Disease Progression - Insulin Like Growth Factor (IGF) Binding Protein -3|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||mg/L||Full Range|Median
1426740|NCT01036321|Secondary|Biomarkers of Disease Progression - Free Testosterone|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||pg/ml||Full Range|Median
1426741|NCT01036321|Secondary|Biomarkers of Disease Progression - Estradiol|Median change from baseline to post intervention. Steroid hormones: pre-treatment (Pre:) versus post treatment (Post:).|Up to 6 weeks|All participants who were randomized to a study arm.|||pmo/L||Full Range|Median
1426742|NCT01036321|Secondary|Change in Plasma Concentrations of Isoflavone|Plasma concentrations of isoflavone: Genistein from baseline to post intervention by study arm.|Up to 6 weeks|All participants who were randomized to a study arm.|||mg||Full Range|Median
1426743|NCT01036321|Secondary|Biomarkers of Disease Progression - Serum PSA|Median change from baseline to post intervention: Prostatic specific antigen (PSA). All Participants (ALL); Caucasian Men only (CM only); African American Men only (AAM only).|Up to 6 weeks|All participants who were randomized to a study arm.|||ng/mL||Full Range|Median
1426744|NCT01036321|Primary|Number of Toxicity Events by Final Attribution and Treatment Arm|Safety: Incidence of Adverse Events (AEs) occurring during intervention with either 20 mg purified isoflavones bid or placebo. Serious Adverse Event (SAEs) and other Adverse Event (AE) details are also reported in the Adverse Event sections.|Up to 6 weeks|All participants who were randomized to a study arm.|||Toxicity Events|||Number
1426745|NCT01036321|Primary|Median Change in Percent Ki-67 From Baseline|Efficacy: Change in percent Ki-67 evaluated in prostate cancer (PCa) tissue specimens after 3-6 weeks of intervention with purified isoflavones (40 mg daily) vs. Placebo.|Baseline to post intervention - up to 6 weeks|All participants who were randomized to a study arm.|||percentage of tumor cells||Full Range|Median
1426746|NCT01036165|Secondary|Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.|The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at Week 12||||Percentage of subjects||95% Confidence Interval|Mean
1426747|NCT01036165|Primary|The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as ‘Easy to Use’ or ‘Very Easy to Use’ for Self-injection in a User Trial Questionnaire.|Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 Weeks||||Proportion of subjects||95% Confidence Interval|Mean
1429736|NCT01012167|Secondary|Laboratory Measures - Sodium|Sodium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||mE/qL||Standard Deviation|Mean
1426748|NCT01036022|Secondary|Volume of Distribution Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data|Volume of distribution derived from concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.|Day 1 (1 hour, 2 hour, 3 hour post dose), Week 1 (anytime relative to the last dose), Week 2 (anytime relative to the last dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population.||||||
1426749|NCT01036022|Secondary|Plasma Clearance Estimated Based on Population Pharmacokinetic Analysis of Healthy Volunteers (Historical Data) and Patient Data|Clearance derived from plasma concentration-time data was planned to be combined with data from healthy volunteers from Phase I study to characterize the population pharmacokinetics of GSK1399686. However data for this outcome measure was not collected.|Day 1 (1 hour, 2 hour, 3 hour post dose), Week 1 (anytime relative to the last dose), Week 2 (anytime relative to the last dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population.||||||
1426750|NCT01036022|Secondary|Pre-dose Trough Concentration at the End of the Dosing Interval (Cτ) on Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing|Cτ was derived on Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).|Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population. Data is presented for the participants available at the time of assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1426751|NCT01036022|Secondary|Mean Maximum Observed Concentration (Cmax) on Day 1 and Day 28 Derived From Observed Plasma Concentrations of GSK1399686 After Repeated Oral Dosing|Cmax was derived on Day 1 and Day 28 from observed plasma concentrations of GSK1399686 after repeated oral dosing. Blood samples were collected on Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose).|Day 1 (1 hour, 2 hour, 3 hour post dose) and Day 28 (Week 4 at pre dose, 1 hour, 2 hour, 3 hour and 4 hour morning post dose)|PK Population. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
1426752|NCT01036022|Secondary|Mean Fecal Lactoferrin Levels Over Time|Fecal lactoferrin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Lactoferrin is an iron binding glycoprotein that is the major component of the secondary granules of polymorphonuclear neutrophils (but not monocytes and lymphocytes). Lactoferrin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Lactoferrin plays an important role in the innate immunity as a bactericidal and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||µg/L||Geometric Coefficient of Variation|Geometric Mean
1426753|NCT01036022|Secondary|Mean Fecal Calprotectin Levels Over Time|Fecal calprotectin, a non-invasive surrogate marker of inflammation in the small intestine, and levels of which was associated with mucosal healing. Calprotectin is a calcium and zinc-binding protein found in neutrophils, monocytes and macrophages. Calprotectin is produced in significant amounts by inflammatory cells. Fecal levels of this protein has been demonstrated to correlate with colorectal and intestinal inflammation. Calprotectin plays a regulatory role in the inflammatory process and used as a diagnostic biomarker. It was assessed from Week 1 to Week 6.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||μg/g||Geometric Coefficient of Variation|Geometric Mean
1426754|NCT01036022|Secondary|Median Time to Clinical Response and Clinical Remission|Time to clinical response was defined as the number of days between first dose of study medication and first day of at least 3 consecutive days with SCCAI score decreased for >2 points in comparison with baseline (Day -1 value). Time to clinical remission was defined as the number of days between the first dose of study medication and the first day of at least 3 consecutive days with SCCAI score < 3. Time to clinical response and remission was derived using daily diary data. Participants who did not meet the criteria for clinical response or clinical remission were censored at their last day on study medication.|Up to Week 6|ITT Population. Data is presented for the participants available at the time of assessment. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||Days||Full Range|Median
1426755|NCT01036022|Secondary|Number of Participants With Clinical Response and Clinical Remission at Week 4 and Week 6|Participants were defined as clinical responders if the average change from baseline total SCCAI score was <-2. (i.e. the post dose total SCCAI score was decreased by >2 points compared to the baseline total SCCAI score). Baseline was defined as the value on Day -1. The change from baseline total SCCAI score was derived by subtracting the baseline value (Day -1) from the individual post-dose values. Participants were defined as in clinical remission if the post dose total SCCAI score was <3 and baseline SCCAI score was not <3 (i.e . =>3).|Week 4 and Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the eCRF without any imputations added.|||Participants|||Number
1426763|NCT01036022|Primary|Number of Participants With Clinical Chemistry Data Outside the Reference Range|Normal reference range for clinical chemistry parameters include: alanine amino transferase (ALT) 0-41 international units per liter (IU/L); aspartate amino transferase (AST) 10 – 38 IU/L; alkaline phosphatase 40 – 129 IU/L; gamma glutamyl transferase (GGT) 10 – 66 IU/L; albumin 39 – 48 gram per liter (g/L); total protein 66 – 87 g/L; direct bilirubin 0 - 5.13 micromole per liter (µmol/L); total bilirubin 0 - 17.1 µmol/L; creatinine 61.88 - 106.08 µmol/L; uric acid 202.232 - 416.36 µmol/L; calcium 2.0958 - 2.42015 millimole per liter (mmol/L); cholesterol 2.8446 - 5.9478 mmol/L; chloride 98 – 106 mmol/L; glucose 2.2204 - 11.102 mmol/L; potassium 3.4 - 4.5 mmol/L; magnesium 0.6576 - 1.0686 mmol/L; sodium 0 - 2.26 mmol/L; urea/ blood urea nitrogen (BUN) 0 - 17.85 mmol/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.|Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1426756|NCT01036022|Secondary|Mean Simple Clinical Colitis Activity Index (SCCAI) Score|SSCAI included composite score: bowel frequency during day on a scale of 0-3 defined as 0 was <= 3, 1= 4 to 6, 2= 7 to 9 and 3 was > 9, during night on a scale of 0-2 defined as 0= none, 1=1 to 3 and 2 was >=4, defecation urgency on a scale of 0-3 defined as 0=none, 1=hurry, 2=immediately and 3=incontinence, blood in stool on a scale of 0-3 defined as 0= none, 1= trace, 2= occasionally frank and 3= usually frank, general well being on a scale of 0-4 defined as 0=very well, 1= slightly below par, 2= poor, 3 = very poor and 4= terrible, extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis) on a scale of 0-1 defined as 0= absent, 1= present. The SCCAI score was calculated as a sum of scores for each individual component of the SCCAI. Minimum score 0, maximum score 19. Higher score implied worsening of symptoms. Participants were given a diary to score each component of SCCAI each morning. Average SCCAI scores over last 3 days were used for each Week.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed. Analysis was done on OC data referred to data collected on the electronic case report form (eCRF) without any imputations added.|||Score on scale||Standard Error|Least Squares Mean
1426757|NCT01036022|Primary|Mean Concentration of GSK1399686 in Colon Biopsy Obtained Within 24 h After the Last Dose|The assessment was done on the samples collected from the sigmoid colon and from the rectum obtained within 24 hour after the last dose on Week 4 visit after endoscopic evaluation of respective area for determination of GSK1399686 concentration. Non-quantifiable (NQ) concentration values were imputed as 0.|Week 4|Pharmacokinetic (PK) Population which was defined as the participants in the ITT Population for whom a PK sample was obtained and analysed. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)/mL||Standard Deviation|Mean
1426758|NCT01036022|Primary|Mean Treatment Effects on Basal Morning Cortisol and Adrenocorticotropic Hormone (ACTH) Stimulated Cortisol Levels at Week 4 in Comparison With Baseline|Treatment effects was assessed using a low-dose ACTH stimulation test which was performed on Day 1 pre dose (Baseline) and at Week 4 visit. A blood sample for plasma cortisol was taken immediately, before and 30 minutes after an intravenous injection of 1 microgram (μg). tetracosactide acetate, a synthetic peptide displaying the same physiological properties as ACTH. The change from morning basal cortisol was calculated for Day 1 pre-dose (ACTH1) and Week 4 (ACTH2) using the equation: ACTH1 = Day 1 post ACTH - Day 1 pre ACTH; ACTH2 = Week 4 post ACTH - Week 4 pre ACTH. The change from morning basal cortisol between Week 4 and Day 1 (ACTH effect) was calculated as : ACTH effect = ACTH2 – ACTH1. The difference in morning basal cortisol between Week 4 and Day 1 (ACTH morning) was calculated as:- ACTH morning = Week 4 pre ACTH – Day 1 pre ACTH. Adrenocorticol function was classed as normal if the change from post ACTH to pre ACTH (using ACTH1 and ACTH2) was >= 200 nanomoles per liter.|Baseline (Day 1, pre dose) and Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Nanomoles per liter||Standard Error|Least Squares Mean
1426759|NCT01036022|Primary|Number of Participants With Abnormal Electrocardiography (ECG) Findings|Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, and QTc intervals. Criteria for ECG parameter values meeting PCI included absolute QTc interval >500 millisecond (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Only those participants for whom at least one value of abnormal clinically significant or abnormal not clinically significant ECG findings were reported at any visit are summarized.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1426760|NCT01036022|Primary|Number of Participants With Vital Sign Outside Range of Potential Clinical Importance (PCI)|Vital signs assessment included systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate (HR). Criteria for vital sign values meeting PCI included: SBP < 85 and > 160 millimeter of mercury (mmHg); DBP < 45 and > 100 mmHg and HR < 40 and > 110 beats per minute (bpm). The assessments were done on screening, Week 2, Week 4 and Week 6. The participants with values higher and lower than the PCI range is presented. Only those parameters for which at least one value of PCI was reported at any visit are summarized.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1426761|NCT01036022|Primary|Number of Participants of Abnormal Urinalysis Dipstick Results|The urinalysis parameters included urine occult blood, urine general, glucose, ketones and protein by dipstick analysis. The assessments were done on screening, Week 2, Week 4 and Week 6.The number of participants with results of 0, 0.3, 1, 1+, 1.5, 10, 2+, 3+, 30, 4+, 5+, 55, not rated (NR), positive (pos) and trace is presented.|Screening (Day -7 to -1), Week 2, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1426762|NCT01036022|Primary|Number of Participants With Hematology Data Outside the Reference Range|Normal reference range for clinical chemistry parameters include: basophils 0 - 0.2 giga cells (GI)/L; eosinophils 0 - 0.4 GI/L; lymphocytes 1 - 4.8 GI/L; monocyte 0 - 0.8 GI/L; total neutrophils (total absolute neutrophils count) 1.8 - 7.7 GI/L; platelet count 150 – 400 GI/L; red blood cell count 4.5 - 5.9 GI/L; white blood cell count 3.9 - 10.6 GI/L; hemoglobin 135 – 175 g/L; hematocrit 0.41 - 0.53 ratio; mean corpuscle hemoglobin concentration 310 – 370 g/L; mean corpuscle hemoglobin 26 – 34 picogram (PG); mean corpuscle volume 80 – 100 femtoliter (FL); reticulocytes 0.05 - 0.1 trillion cells (TI)/L. Number of participants with high and low values compared to the reference range is presented. Only those parameters for which at least one value outside the reference range was reported at any visit are summarized.|Screening (Day -7 to -1), Day 1, Week 1, 2, 3, 4 and 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1426777|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 42-day (Days 0-41) follow up period after first vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1426887|NCT01034592|Secondary|Red Blood Cell (RBC) Transfusions|The effect on red blood cell (RBC) transfusions was assessed as the number of participants that achieved a greater than 50% decrease in RBC transfusion requirements.|6 months|Both participants were assessed and contributed to the analysis.|||Participants|||Count of Participants
1426764|NCT01036022|Primary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Week 6|Intent-To-Treat (ITT) Population was defined as all participants who were randomized to treatment, who received at least one dose of study medication and who had at least one valid post dose assessment.|||Participants|||Number
1426765|NCT01036009|Post-Hoc|Time Until Late Relapse|Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as >5% blasts in bone marrow|24-36 months post-transplant|intervention patients who relapsed after the 2 year primary study endpoint|||months||Full Range|Mean
1426766|NCT01036009|Post-Hoc|Late Relapses|The number of patients who relapsed after 2-year primary endpoint. To assess a potential for late relapse-rate in the intervention arm only, patients in the intervention arm were provided additional follow-up until 3-yrs post transplant. The criterion for relapse was >5% blasts in bone marrow.|24-36 months post-transplant|surviving patients in the intervention arm who had not relapsed as of 24 months were followed for an additional 12 months (until 3 years post-transplant)|||participants|||Number
1426767|NCT01036009|Secondary|The Incidence of Chronic GVHD (cGVHD).|"Diagnostic criteria of cGVHD from: Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host disease: I Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 2005;11:945-955.~The diagnosis of chronic GVHD requires the following:~1) Distinction from acute GVHD; 2) Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests; 3) Exclusion of other possible diagnoses.~Scoring of organ manifestations requires careful assessment of signs, symptoms, laboratory values, and other study results. A clinical scoring system (0-3) is used for evaluation of the involvement of individual organs and sites. Global assessment of severity (mild, moderate, or severe) is derived by combining organ- and site-specific scores."|2 years post transplant||||participants|||Number
1426768|NCT01036009|Secondary|The Incidence of Acute Graft Versus Host Disease (aGVHD).|"Definition and diagnostic criteria of aGVHD according to: 1994 Consensus Conference on Acute GVHD Grading. Przepiorka D1, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. Bone Marrow Transplant. 1995 Jun;15(6):825-8.~In this system, patients are divided into one of four grades (I-IV) depending on the degree, or stage, of involvement in three organs. The skin is staged with percent body surface involved, the liver is staged with degree of bilirubin elevation, and the gastrointestinal tract is staged with amount of diarrhea."|2 years post transplant||||participants|||Number
1426769|NCT01036009|Secondary|2 Years Post-transplant Survival.||2 years post transplant||||participants|||Number
1426770|NCT01036009|Primary|Relapse at 2 Years Post-transplant.|Definition of relapse was >5 % blasts in bone marrow|2 years post transplant.||||participants|||Number
1426771|NCT01035944|Secondary|Determine Cost Efficacy, Hemostasis and Patient Comfort Between Wounds Debrided at Bedside With HemCon Dressings & Wounds Debrided in Operating Room Setting.||2 days and 5 days after debridement.|||||||
1426772|NCT01035944|Primary|Demonstrate That Debridements Using HemCon Dressings at Bedside Can be Performed Safely Without Excessive Bleeding; Compare Levels of Bacterial Load Between Debrided Wounds Treated With HemCon Dressings vs. Wounds Treated With Gauze & Saline Dressings.||2 days and 5 days after debridement.|Zero participant data were analyzed. Study was terminated early; unable to reach enrollment milestones.||||||
1426773|NCT01035905|Primary|Lens Awareness|Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week’s wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.|4 weeks of wear|Per Protocol|||Participants|||Number
1426774|NCT01035788|Primary|Clinician-Administered PTSD Scale (CAPS)|The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.|treatment end (approximately 10 weeks after session 1 of the interventions)|This analysis was intention to treat and included the 30 participants of the original 34 who completed the CAPS interview at treatment end.|||units on a scale||95% Confidence Interval|Least Squares Mean
1426775|NCT01035749|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 364)|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1426776|NCT01035749|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination.|During the 21-day (Days 0-20) follow-up period after booster vaccination.|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study."|||Subjects|||Number
1428433|NCT01022853|Secondary|Vss of Volasertib|Volume of distribution at steady state (Vss) of Volasertib in Cycle 1.|0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion|PK analysis set.|||L||Geometric Coefficient of Variation|Geometric Mean
1426778|NCT01035749|Secondary|Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges|Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).|At Days 0, 21, 42, 182 and 189|"The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study at Days 182 and 189."|||Subjects|||Number
1426779|NCT01035749|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-364) following first vaccination|The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1426780|NCT01035749|Secondary|Number of Subjects Reporting Any Medically Attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (Days 0-364) following the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1426781|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following booster dose|"The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.~Note: 1 subject moved out of the study area thereby withdrawing from the study."|||Subjects|||Number
1426782|NCT01035749|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1426783|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local AEs|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity|During the 7-day (Days 0-6) post-vaccination period following booster dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1426784|NCT01035749|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1426785|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Fold increase||95% Confidence Interval|Geometric Mean
1426786|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Fold increase||95% Confidence Interval|Geometric Mean
1426787|NCT01035749|Secondary|GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Fold increase||95% Confidence Interval|Geometric Mean
1426788|NCT01035749|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1|GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1426789|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, Day 182 and Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Subjects|||Number
1426790|NCT01035749|Secondary|Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Subjects|||Number
1426791|NCT01035749|Secondary|The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1|A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available|||Subjects|||Number
1426792|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Subjects|||Number
1426793|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.|At Day 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Subjects|||Number
1426794|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Subjects|||Number
1426795|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titers were expressed as GMTs.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.|||Titers||95% Confidence Interval|Mean
1426796|NCT01035749|Secondary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available|||Subjects|||Number
1426797|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Days 0, 182 and 189|The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 & booster on Day182 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182&189D after the 1st dose were available|||Titers||95% Confidence Interval|Geometric Mean
1426798|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as GMTs.|At Day 0 and Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 & 21 as PP & for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 & 182 days after the 1st vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
1426799|NCT01035749|Secondary|HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain|Antibody titres were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.|||Titers||95% Confidence Interval|Geometric Mean
1428434|NCT01022853|Secondary|CL of Volasertib|Total plasma Clearance (CL) of Volasertib in Cycle 1.|0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion|PK analysis set.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1426800|NCT01035749|Primary|HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP & for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 & 42 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1426801|NCT01035749|Primary|Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.|||Subjects|||Number
1426802|NCT01035749|Primary|Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain|Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) & for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.|||Subjects|||Number
1426803|NCT01035658|Primary|Phase I - Dose Limiting Toxicites|As requested, this outcome measure reports the number of patients experiencing dose limiting toxicites (DLTs) in the Phase I portion of the study|18 months||||participants|||Number
1426804|NCT01035658|Secondary|To Evaluate the Toxicity of the Combination of Pazopanib and Liposomal Doxorubicin||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.||||||
1426805|NCT01035658|Secondary|To Determine the Efficacy of Pazopanib/Liposomal Doxorubicin (Response Rate, Progression-free Survival, Overall Survival) Separately in the Subsets of Patients With Platinum-sensitive and Platinum-refractory Ovarian Carcinoma||18 months|||||||
1426806|NCT01035658|Secondary|To Determine the Overall Survival of Patients With Relapsed/Refractory Ovarian Cancer Following Treatment With Pazopanib and Liposomal Doxorubicin.||18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.||||||
1426807|NCT01035658|Primary|Phase II: Progression Free Survival|Defined as from date of randomization until objective tumor progression or death.|18 months|Per protocol, study did not proceed to phase II based on analyses from phase I. Therefore, Phase II outcomes (all outcomes other than determination of the MTD) were not evaluated and will not be posted.||||||
1426808|NCT01035658|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pazopanib and Liposomal Doxorubicin|The MTD of the drug combination will be determined as the highest dose at which ≤1 of 6 subjects experiences a Grade 3 or Grade 4 DLT according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months||||mg|||Number
1426809|NCT01035606|Secondary|Change to Attention and Executive Functioning Composite Scores|"Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3.~Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning.~The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time."|5 weeks (After completion of Arm 1 and Arm 2)||||Aggregate Z-scores||Standard Deviation|Mean
1426810|NCT01035606|Secondary|Change From Baseline to Post-training for Task Errors on a Functional Performance Measure|Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).|5 weeks (After completion of Arm 1 and Arm 2)||||Number of task failures||Standard Deviation|Mean
1426811|NCT01035606|Primary|Self-report|Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.|5 Weeks (After completion of active trainings in Arm 1 and Arm 3)||||units on a scale||Standard Deviation|Mean
1426812|NCT01035346|Secondary|Rating of Study Medication Relative to Usual Medication|Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||units on a scale||Standard Deviation|Mean
1426888|NCT01034592|Primary|Red Blood Cell (RBC) Transfusion Independence|"Red blood cell (RBC) transfusion independence is reported as the number of subjects who achieve a continuous absence of the intravenous infusion of any RBC transfusion during any consecutive rolling 56 days during the treatment period."|6 months|All treated subjects were analyzed.|||participants|||Number
1426813|NCT01035346|Secondary|Global Assessment of Study Medication as an Antipyretic|Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||units on a scale||Standard Deviation|Mean
1426814|NCT01035346|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||percentage of participants|||Number
1426815|NCT01035346|Secondary|Time to Treatment Failure|Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.|0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||hours||95% Confidence Interval|Median
1426816|NCT01035346|Secondary|Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8|Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||Degrees Fahrenheit||Standard Deviation|Mean
1426817|NCT01035346|Secondary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)|STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 4, 0 to 8 hours|ITT population included all randomized participants who received study medication and provided a baseline temperature assessment.|||Degrees Fahrenheit||Standard Deviation|Mean
1426818|NCT01035346|Primary|Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)|STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.|0 to 6 hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline temperature assessment.|||Degrees Fahrenheit||Standard Deviation|Mean
1426819|NCT01035333|Secondary|Patient Satisfaction||6 months|Patients who completed 6 months of the study.|||participants|||Number
1426820|NCT01035333|Primary|Weight Loss|Weight loss acheived during time on study up to 6 months.|6 months|All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months.|||percentage of weight||Standard Deviation|Mean
1426821|NCT01035255|Secondary|Percentage of Participants With New Onset of Atrial Fibrillation (AF)|Percentage of participants with New Onset of Atrial Fibrillation The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).|up to 51 months|The new onset atrial fibrillation (AF) analysis was based on a subset of FAS: i.e., for patients without a history of AF at baseline (patients with a history of AF were excluded from this analysis).|||Percentage of participants|||Number
1426822|NCT01035255|Secondary|Number of Patients With First Confirmed Renal Dysfunction|Number of patients with first confirmed renal dysfunction|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations|||participants|||Number
1426823|NCT01035255|Secondary|Change From Baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 8 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 8|FAS included all randomized patients with two exclusions: 6 pts who did not qualify for randomization but were misrandomized into the study and did not receive study meds; 37 pts because they were randomized at sites that were closed due to serious GCP violations The analysis included all FAS patients with at least one KCCQ data up-to Month 8.|||KCCQ Score||Standard Error|Least Squares Mean
1426824|NCT01035255|Secondary|Number of Patients Reported With Adjudicated Primary Causes of Death|Number of patients reported with adjudicated primary causes of death. The data is on Randomization population up to March 31, 2014|up to 51 months|Randomized set (RAN): Consisted of all patients who received a randomization number, regardless of receiving trial medication.|||participants|||Number
1426825|NCT01035255|Secondary|Number of Patients - All-cause Mortality|Number of patients - All-cause mortality. All-cause mortality is common in Heart Failure HF patients this measures how many patients had this event. The data is on FAS population up to March 31, 2014|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations|||participants|||Number
1426826|NCT01035255|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to 51 months|Full Analysis Set (FAS) included all randomized patients but the following two exclusions: 6 patients who did not qualify for randomization but were inadvertently randomized into the study and did not receive double-blind study medication; 37 patients because they were randomized at sites that were closed due to serious GCP violations|||participants|||Number
1426827|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmax|Cmax is the maximum (peak) blood drug concentration after dose administration (ng/mL) calculated as the maximum of C1h and C2h. C1h was 1 hour post-dose blood concentration (ng/mL) and C2h was 2 hour post-dose blood concentration (ng/mL). C1h and C2h post-dose samples were collected from all patients in both arms at Visit 3. Steady-state for the C1h and C2h samples was defined as continuous administration of the same dose in the previous 4 days and the day on which the C1h and C2h samples were collected. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid C1h and C2h everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|Safety Set consists of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.|||ng/mL||Standard Deviation|Mean
1426828|NCT01035229|Secondary|Pharmacokinetics Assessments - Cmin|Cmin is the pre-dose blood concentration at steady-state (ng/mL). Pre-dose (Cmin) blood samples were collected from all patients in both arms at Visit 3. Steady-state for the Cmin sample was defined as continuous administration of the same dose in the last 4 days prior to the collection of the Cmin sample. Steady-state for the 5 mg every other day regimen was defined as the state when the 5 mg dose was taken 2 days and 4 days before sampling. PK samples were only drawn at visit 3, and only analyzed for patients receiving everolimus at steady state (if patients had received the dose the previous 4 days). In addition summary statistics were only done for each everolimus dose when 3 samples were available. Only valid pre-dose (Cmin) everolimus samples were included in the analysis.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|Safety Set consisted of all patients who received at least one dose of study treatment with a valid postbaseline assessment. All PK analyses were based on the Safety Set.|||ng/mL||Standard Deviation|Mean
1426829|NCT01035229|Secondary|Time to Definitive Deterioration of EORTC QLQ-C30 Scores|The primary quality of life endpoint was the time to definitive 5% deterioration from baseline in the global health status/quality of life scale of the EORTC QLQ-C30 questionnaire. Definitive deterioration by at least 5% is defined as a decrease in score by at least 5% compared to baseline, with no later observed increase above this threshold. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the healthrelated quality of life (QoL) of cancer patients participating in international clinical trials. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|Until all patients have disease progression or leave study due to intolerable adverse events - Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
1426830|NCT01035229|Secondary|Time to Definitive Deterioration of ECOG Performance Score (PS) Score|Change in Eastern Cooperative Oncology Group (ECOG) were assessed by time to definitive performance status deterioration by at least one category on the ECOG scale. Deterioration was considered definitive if no improvement in the ECOG PS was observed at a subsequent measurement. ECOG PS: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5=Dead|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient.|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
1426831|NCT01035229|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR is defined as the proportion of participants with a best objective response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST. The BOR was the best response recorded from the start of the treatment until disease progression. CR is disappearance of all target lesions; PR is at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is at least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.|||Percentage of Participants|||Number
1426832|NCT01035229|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of randomization to the date of the first documented radiologic confirmation of disease progression. Since the study did not meet the primary objective, TTP was not formally tested.|Until all patients have disease progression or leave study due to intolerable adverse events- Estimate of 1 year for each patient|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
1426833|NCT01035229|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. The comparison of OS between the 2 arms was done using a stratified log-rank test at one-sided 2.5% level of significance.|When 454 OS events were observed|The Full Analysis Set (FAS) comprised all randomized patients.|||Months||95% Confidence Interval|Median
1426844|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426834|NCT01035138|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12|RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. Reported the change in number of hospitalizations per participant to week 12.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||number of hospitalizations||Standard Deviation|Mean
1426835|NCT01035138|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) at Week 24|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numbers 1-3 are not added for total score. Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426836|NCT01035138|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24|The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the patient’s behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426837|NCT01035138|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24|The MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures. The total score ranges from 0 to 30, with a lower score indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426838|NCT01035138|Secondary|Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24|The CDR-SB is a semi-structured interview of participants and their caregivers. The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 24 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426839|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
1426840|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug|ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.|Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
1426841|NCT01035138|Secondary|Mean Concentration of LY450139||3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)|Participants who completed Study LFAN, took study drug in extension study and had pharmacokinetics measurements.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1426842|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426843|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426845|NCT01035138|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1426846|NCT01035138|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio for the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator. Due to insufficient sample size, this analysis was not done.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Due to insufficient sample size, this analysis was not done.||||||
1426847|NCT01035138|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12|The vMRI assessment of right hippocampal and left hippocampal volume is reported. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization), 12 weeks (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||cubic millimeter (mm³)||Standard Error|Least Squares Mean
1426848|NCT01035138|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||percentage of change||Standard Error|Least Squares Mean
1426849|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
1426850|NCT01035138|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug|The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.|Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug|Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
1426851|NCT01035060|Primary|Muscle Satellite Cells|Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.|Baseline, 2 days post-injury, 7 days post-injury||||Number of Pax7+ cells/muscle fiber||Standard Error|Mean
1426852|NCT01035047|Secondary|Stress Testing-related Adverse Event||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis|||participants|||Number
1426853|NCT01035047|Secondary|Mortality||Index Hospitalization through 90 days|Data from all participants was used for outcome analysis.|||participants|||Number
1426854|NCT01035047|Secondary|Acute Coronary Syndrome||Index Hospitalization discharge through 90 days|Data from all participants was used in outcome analysis.|||participants|||Number
1426855|NCT01035047|Secondary|Length of Stay||Duration of Index Hospitalization, an average of 1-2 days|Data from all participants was used in outcome analysis.|||hours||Full Range|Median
1426856|NCT01035047|Primary|The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.||Index Hospitalization through 90 days|Data from all participants was used in the primary outcome analysis.|||participants|||Number
1426857|NCT01034709|Primary|a) CMV Viral Load|The CMV viral load was measured by both the artus CMV RG PCR test and the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational sites and then the percent agreement between the two tests was determined.|3 months||||percentage of agreement|||Number
1426858|NCT01034657|Secondary|Time to Cause-specific Death - Overall Period|Time to cause-specific death was defined as the time from start of treatment to death related to MDS.|52 weeks|Time to cause-specific death could not be evaluated because there was no cause-specific death.||||||
1426859|NCT01034657|Secondary|Disease-free Survival (DFS) - Overall Period|DFS was defined as the time from start of treatment to the time to relapse.|52 weeks|DFS could not be evaluated because there was no disease-free period.||||||
1426860|NCT01034657|Secondary|Progression-free Survival (PFS) - Overall Period|PFS was defined as the time from start of treatment to disease progression or death from MDS.|52 weeks|PFS could not be evaluated because there was no progression.||||||
1426861|NCT01034657|Secondary|Event-free Survival (EFS) - Overall Period|EFS was defined as the time from start of treatment to failure or death from any cause.|52 weeks|Event-free survival could not be evaluated because there was no response, no progression or no disease-free period.||||||
1426862|NCT01034657|Secondary|Time to Response - Overall Period|Time to response was defined as the time from start of treatment to the first documented response (complete [CR] or partial [PR]) according to modified IWG criteria for HI.|52 weeks|Time to response could not be evaluated because there was no response.||||||
1426863|NCT01034657|Secondary|Overall Survival (OS) - Overall Period|OS was defined as the time from start of treatment to death from any cause.|48 weeks|All participants from the core phase were analyzed.|||months||90% Confidence Interval|Median
1426864|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Participants from the randomized phase, who had values at week 52, were included in the analysis.|||units on a scale||Standard Deviation|Mean
1426865|NCT01034657|Secondary|Mean Single Scoring Values of the IPSS - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.|||units on a scale||Standard Deviation|Mean
1426866|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Randomized Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|52 weeks|Only participants from the randomized phase, who had values at week 52, were included in the analysis.|||Percentage of participants|||Number
1426867|NCT01034657|Secondary|Frequency Distribution of IPSS Score Status - Core Phase|The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast <5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex >= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high >=2.5 points (6 months of median survival).|baseline|All participants from the core phase were analyzed.|||Percentage of participants|||Number
1426868|NCT01034657|Secondary|Percentage of Participants With Objective Response During the Randomized Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|32 weeks, 48 weeks|Participants from the randomized phase, who had valid data, were analyzed.|||Percentage of participants|||Number
1426869|NCT01034657|Secondary|Percentage of Participants With Objective Response During Core Phase|Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb >= 11 g/dL platelets >=100 X 10^9/L, neutrophils >= 1.0 x 10^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by>=50% over pretreatment but still >5% (ellularity and morphology not relevant). HI-P (pretreatment, < 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; HI-N (pretreatment, < 1.0 x 109/L) = at least 100% increase and an absolute increase > 0.5 x 10^9/L.|16 weeks|Participants from the core phase, who had valid data, were analyzed.|||Percentage of participants|||Number
1426870|NCT01034657|Secondary|Percentage of Participants With HI-E - Randomized Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|32 weeks, 52 weeks|Participants from the randomized phase, who had valid response data, were analyzed.|||Percentage of participants|||Number
1440933|NCT00928187|Primary|Number of Patients With Plasma HIV RNA < 50 Copies/mL||48 weeks|ITT|||participants|||Number
1426871|NCT01034657|Primary|Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase|HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, <11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, < 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with > 20 x 109/L and platelets Increase from < 20 x 109/L to > 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, < 1.0 x 109/L): at least 100% increase and an absolute increase > 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|16 weeks|Participants from the core phase, who had valid response data, were analyzed.|||Percentage of participants|||Number
1426872|NCT01034631|Secondary|Exploratory Objective: Correlation of PFS With Biomarkers|Exploratory analysis of serum biomarkers were undertaken to generate a potential signature for response. The correlation with 6 month progression free survival P value for four plasma biomarkers is reported.|6 months|Analysis was pre-specified to look at the correlation irrespective of arm.|||Correlation with PFS P Value|||Number
1426873|NCT01034631|Secondary|Phase II: Overall Survival|Determine overall survival probability, up to a maximum of 5 years from registration for protocol therapy.|60 months||||probability of OS at 60 months.|||Number
1426874|NCT01034631|Secondary|Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.|Determine adverse events of everolimus and BNC105P when administered as a combination or sequential regimen. Total number of serious and non-serious adverse events for Arm A and Arm B are summarized. Complete adverse event information is supplied in the Adverse Events reporting section.|12 months||||number of adverse events|||Number
1426875|NCT01034631|Secondary|Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.|Median time to progression for arm P participants who crossed over to BNC105P monotherapy after progression. Progression is defined per RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|12 months||||months||95% Confidence Interval|Median
1426876|NCT01034631|Secondary|Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone|Objective response is defined as a confirmed CR or PR per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|12 months||||Participants|||Count of Participants
1426877|NCT01034631|Secondary|Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.|Determine the PK Profile for BN105P in combination with everolimus by calculating the geometric mean half-life of BNC105P|12 months|14 participants has sufficient data collected for the analysis of this objective|||hours||Full Range|Geometric Mean
1426878|NCT01034631|Secondary|Phase I: Response Rate of BNC105P in Combination With Everolimus.|Number of objective responses per RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months||||Participants|||Count of Participants
1426879|NCT01034631|Primary|Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.|Improvement in 6-month PFS with the addition of BNC105P to everolimus. Progression is defined using RECIST criteria as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|6 months||||probability of 6MPFS|||Number
1426880|NCT01034631|Primary|Phase I: Toxicities of BNC105P in Combination With Everolimus.|Determine the toxicities of BNC105P in combination with everolimus. Drug-related treatment emergent adverse events by CTCAE grade 2 or greater are reported|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months|12 participants who completed at least one cycle of combination therapy.|||participants|||Number
1426881|NCT01034631|Primary|Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.|Phase I|Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months|12 participants completed at least one cycle of combination therapy and were evaluable.|||mg/m^2|||Number
1426882|NCT01034592|Secondary|Toxicity|Toxicity was assessed as the number of adverse events related to lenalidomide.|6 months|Both participants were assessed and contributed to the analysis.|||Related Adverse Events|||Number
1426883|NCT01034592|Secondary|Duration of Response|The response duration was measured from the last of the consecutive 56 days during which the subject was free of red blood cells (RBC) transfusions to the date of the first RBC transfusion after the 56-day RBC-transfusion-free period.|6 months|Both participants were assessed and contributed to the analysis, but never demonstrated any therapeutic response.|||days||Full Range|Median
1426884|NCT01034592|Secondary|Platelet Response|The effect on platelet levels as assessed as the change in platelet count from baseline.|6 months|Both participants were assessed and contributed to the analysis.|||1000/uL||Full Range|Median
1426885|NCT01034592|Secondary|Neutrophil Response|The effect on neutrophil levels was assessed as the change in neutrophil count from baseline.|6 months|Both participants were assessed and contributed to the analysis.|||1000/uL||Full Range|Median
1426886|NCT01034592|Secondary|Hemoglobin Concentration|The effect on hemoglobin concentration was assessed as the change from baseline, measured in g/dL.|6 months|Both participants were assessed and contributed to the analysis.|||g/dL||Full Range|Median
1426889|NCT01034579|Secondary|Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker|Mean number of T2 active lesions was measured by using MRI scans. SNP5 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Mean number of T2 active lesions segregated on the basis of SNP5 marker variables were reported.|Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||T2 lesions||Standard Deviation|Mean
1426890|NCT01034579|Secondary|Change in Brain Volume as Defined by SNP2 Marker|Change in brain volume was measured as the brain parenchymal fraction using MRI scans. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Change in brain volume segregated on the basis of SNP2 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||cubic millimeter (mm^3)||Standard Deviation|Mean
1426891|NCT01034579|Secondary|Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers|Change in T1 Gd enhancing lesion volume was measured by using magnetic resonance imaging (MRI) scans. SNP4 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). SNP3 is a three-level allele-based association SNP markers. The analysis was based on the number of copies of the allele (0, 1 and 2). Change in T1 Gd enhancing lesion volume segregated on the basis of SNP3 and SNP4 marker variables were reported.|Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study|MRI evaluable population was defined to include all participants from the evaluable population who had at least one post-baseline MRI evaluation during study 24735. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||cubic millimeter (mm^3)||Standard Deviation|Mean
1426892|NCT01034579|Secondary|Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5. SNP2 is two-level genotype-based SNP marker. The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). Number of responders segregated on the basis of SNP2 marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||participants|||Number
1426893|NCT01034579|Primary|Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers|A responder was defined as a participant with no multiple sclerosis (MS) relapse and no Expanded Disability Status Scale (EDSS) progression during 96 weeks in 24735 (NCT00078338). All responders were categorized on the basis of following six SNP markers: SNP1, SNP2, SNP3, SNP4, SNP5, and SNP6. Two types of variables were possible for each SNP marker: two-level genotype-based or three-level allele-based association variables. For the two-level genotype-based SNP markers (SNP2, SNP4, and SNP6), the absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype). For the three-level allele-based association SNP markers (SNP1, SNP3, and SNP5), the analysis was based on the number of copies of the allele (0, 1 and 2). Percentage of responders segregated on the basis of SNP marker variable were reported.|Day 1 of EMR200136_023 study|Evaluable population. Here, 'N' signifies number of participants who were evaluable for this outcome measure and 'n' signifies number of participants who were evaluable for the specified SNP categories.|||percentage of participants|||Number
1426894|NCT01034553|Secondary|Overall Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.|||Months||95% Confidence Interval|Median
1426895|NCT01034553|Secondary|Progression-free Survival||Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years|All patients that received treatment were evaluated.|||Months||95% Confidence Interval|Median
1426896|NCT01034553|Primary|Overall Response Rate to the Combination of MLN8237 and Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma.|sCR: Normal serum FLC ratio, and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, negative immunofixation of the serum and urine, <5% plasma cells in bone marrow, disappearance of any soft tissue plasmacytomas, and normalization of FLC ratio. VGPR:PR and serum and urine M-component detectable by immunofixation but not on electrophoresis, or if serum measurable,≥90% or greater reduction in serum M-component plus urine M-component <100 mg per 24h and if only measurable non-bone marrow parameter was FLC,≥90% or greater reduction in difference from involved and uninvolved FLC levels. PR:≥50% reduction of serum M-protein or reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24h or if FLC, ≥50% decrease in the difference between involved and uninvolved FLC levels or ≥50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥30%, and ≥50% reduction in the size of soft tissue plasmacytomas|Every 28 day cycle(up to 10 cycles)|All patients that received treatment were evaluated.|||percentage of patients per dose level|||Number
1426897|NCT01034553|Primary|Dose-limiting Toxicity (DLT) (Phase I)|"Patients were evaluated over the first cycle of treatment for Dose Limiting Toxicities. For this trail DLTs are as follows:~An AE attributed (definitely, probably, or possibly) to study treatment during cycle 1 and the following criteria:~Grade 4 Neutropenia Grade 4 Thrombocytopenia, or grade 3 with bleeding Febrile neutropenia Creatinine serum great than 2 times baseline or upper limit of normal Grade 3 or higher Fatigue Grade 3 or higher nausea, vomiting, or diarrhea Any grade 3 or higher Non-hematologic toxicity per NCI CTCAE V4.0 Inability to initiate the scheduled cycle 2, day 1 due to toxicity~The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose."|28 days||||participants|||Number
1426898|NCT01034540|Secondary|Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.|"Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose.~Disposition index = MISI x insulin secretion index"|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population excluding subjects with poor compliance and protocol violations.|||Index value||Standard Error|Mean
1426899|NCT01034540|Primary|Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).|Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)|End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)|Per protocol population in which subjects with poor compliance, protocol violations, and without at least one post-randomization outcome data point during each treatment intervention period were removed.|||Index value||Inter-Quartile Range|Median
1426900|NCT01034462|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|"The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product.~The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score."|||units on a scale||Standard Error|Least Squares Mean
1426901|NCT01034462|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
1426902|NCT01034397|Secondary|Change From Baseline to Week 24 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
1426903|NCT01034397|Secondary|Change From Baseline to Week 12 in Neuropeptide Y|Change in Neuropeptide Y was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
1426904|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum DHEA|Change in DHEA was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
1426905|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Dehydroepiandrosterone (DHEA)|Change in DHEA was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
1426906|NCT01034397|Secondary|Change From Baseline to Week 24 in 17OHP|Change in 17OHP was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
1426907|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
1426908|NCT01034397|Secondary|Change From Baseline to Week 12 in 17 Hydroxy Progesterone (17OHP)|Change in 17OHP was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
1426909|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Androstenedione|Change in serum androstenedione was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
1426910|NCT01034397|Secondary|Change From Baseline to Week 24 in Plasma ACTH|Change in plasma ACTH was determined as the difference in the scores at baseline and Week 24.|Week 24|ITT population|||mg/dL||Full Range|Median
1426911|NCT01034397|Secondary|Change From Baseline to Week 12 in Plasma Adrenocorticotrophic Hormone (ACTH)|Change in Plasma ACTH was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
1426912|NCT01034397|Secondary|Change From Baseline to Week 24 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 24.|Week 24|ITT population;|||mg/dL||Full Range|Median
1426913|NCT01034397|Secondary|Change From Baseline to Week 12 in Serum Cortisol|Change in serum cortisol was determined as the difference in the scores at Baseline and Week 12.|Week 12|ITT population|||mg/dL||Full Range|Median
1426914|NCT01034397|Secondary|Change From Baseline to Week 24 in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Week 24|ITT population|||mg/dL||Full Range|Median
1426915|NCT01034397|Secondary|Change From Baseline to Week 12 in C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was measured in milligrams per deciliter (mg/dL).|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mg/dL||Full Range|Median
1426916|NCT01034397|Secondary|Change From Baseline to Week 24 in ESR|ESR is an inflammatory marker and is used to assess disease activity in RA. A reduction in ESR indicates improvement.|Week 24|ITT population|||mm/hr||Full Range|Median
1426965|NCT01034163|Primary|Number of Participants With Adverse Events|Safety monitoring was conducted throughout the study.|23 months|Safety set: The safety set included randomized participants who received at least one dose of study treatment.|||Participants|||Number
1426917|NCT01034397|Secondary|Change From Baseline to Week 12 in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammatory marker and is used to assess disease activity in rheumatoid arthritis (RA). A reduction in ESR indicates improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mm/hr||Full Range|Median
1426918|NCT01034397|Secondary|Health Assessment Questionnaire - Disease Index (HAQ-DI) Scores|The HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426919|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population|||mm||Full Range|Median
1426920|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mm||Full Range|Median
1426921|NCT01034397|Secondary|Patient Global Assessment of Pain|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specific parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||mm||Full Range|Median
1426922|NCT01034397|Secondary|Change From Baseline to Week 24 in Patient Global Assessment of Disease Activity|General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: “In general how would you rate your health over the last 2-3 weeks?”. Participants responded by marking the line and the distance from the left edge was recorded.|Week 24|ITT population|||mm||Full Range|Median
1426923|NCT01034397|Secondary|Change From Baseline to Week 12 in Patient Global Assessment of Disease Activity|General health was assessed using the Patient Global Assessment of Disease Activity, a 0 to 10 mm VAS, where 0 mm = very well and 10 mm = extremely bad. Participants were asked to answer the following question: “In general how would you rate your health over the last 2-3 weeks?”. Participants responded by marking the line and the distance from the left edge was recorded.|Week 12|ITT population|||mm||Full Range|Median
1426924|NCT01034397|Secondary|Change From Baseline to Week 24 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population|||swollen joints||Full Range|Median
1426925|NCT01034397|Secondary|Change From Baseline to Week 12 in SJC|Change in SJC was determined as the difference in the number of swollen joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population|||swollen joints||Full Range|Median
1426926|NCT01034397|Secondary|Change From Baseline to Week 24 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 24. A negative number indicated improvement.|Week 24|ITT population|||tender joints||Full Range|Median
1426927|NCT01034397|Secondary|Change From Baseline to Week 12 in TJC|Change in TJC was determined as the difference in the number of tender joints at baseline and the number at Week 12. A negative number indicated improvement.|Week 12|ITT population|||tender joints||Full Range|Median
1426928|NCT01034397|Secondary|Tender and Swollen Joint Counts|TJC and SJC were determined using the 28 joint counts. Joints were classified as tender/not tender and swollen/not swollen and counted. The scores ranged from 0 to 28. Higher scores indicated higher disease activity.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||joints||Full Range|Median
1426929|NCT01034397|Secondary|Change From Baseline to Week 24 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 24. A negative number indicated improvement.|Week 24|ITT population|||units on a scale||Full Range|Median
1426930|NCT01034397|Secondary|Change From Baseline to Week 12 in DAS28 Global Score|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the ESR (mm/hr) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Change in DAS28 global score was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1427048|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 16|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 16|Not all participants answered every question|||percentage of partcipants|||Number
1426931|NCT01034397|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints (SJC and TJC) using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and global health assessment (participant rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline, Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426932|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population|||units on a scale||Full Range|Median
1426933|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population|||percent change||Full Range|Median
1426934|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426935|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER Wrist Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the wrist ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
1426936|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;|||units on a scale||Full Range|Median
1426937|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;|||percent change||Full Range|Median
1427014|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 8|Not all participants answered every question|||participants|||Number
1426938|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426939|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in DCE-MRI EER MCP Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from the MCP ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
1426940|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population;|||units on a scale||Full Range|Median
1426941|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in DCE-MRI EER Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 24|ITT population|||percent change||Full Range|Median
1426942|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of IRE and Nvox, which are extracted by examining individual signal intensity vs time curves derived from defined ROIs. A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. ME=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of SI until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426943|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in Dynamic Contrast Enhanced (DCE)-MRI Early Enhancement Rate (EER) Global Score|Contrast enhancement was quantified in terms of initial rate of enhancement (IRE) and number of voxels (Nvox), which are extracted by examining individual signal intensity vs time curves derived from defined regions of interest (ROIs). A volume ROI was manually drawn around wrist and MCP 2-5 joints at each visit representative of size/volume of enhancement and underlying inflammation. Maximum enhancement (ME)=mean of ME and Nplateau+Nwashout (Nvoxels) are number of voxels that have a plateau and washout, used to assess volume of enhancing voxels within drawn ROIs. IRE=percentage increase of signal intensity (SI) until l ME is reached calculated as maximum increase in post-contrast SI divided by baseline SI; IRE=increase in SI in %/s from time of onset of enhancement to ME. EER reflects the IRE parameter and the output is the mean from all the assessed ROIs (range=between 0 and 1; 0=no change/enhancement, 1=maximum change/enhancement. Negative change from Baseline score=improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
1426944|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.|||percent change||Full Range|Median
1456132|NCT00807560|Secondary|Percent Completion|Percent of participants who completed the trial to assess feasibility and retention in the trial|at 44 weeks||||percentage of participants|||Number
1426945|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.|||percent change||Full Range|Median
1426946|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426947|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Edema Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for edema via MRI and scored separately based on the proportion of bone with edema. Scoring ranged from 0 to 3 as follows: 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Summing these values yielded a scale from 0-45 for the wrist region, 0-24 for the MCP joints, and 0-69 on aggregate.|Week 12|ITT population; n=number of participants assessed for the specified parameter at a given visit. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
1426948|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥ 20% in TJC and SJC were offered recovery therapy with tocilizumab 8mg/kg and were placed in Placebo-Tocilizumab 8mg/kg group.|||units on a scale||Full Range|Median
1426949|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 cm (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 24|ITT population|||percent change||Full Range|Median
1426950|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426951|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Bone Erosion Score|Bones from the wrist regions (carpal bones, distal radius, distal ulna and metacarpal bases) and the MCP joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranges from 0 (no erosion) to 10 (91-100%). For long bones, the 'assessed bone volume' is from the articular surface to a depth of 1 centimeter (cm) (if the articular surface is absent its best estimated position is used), and in carpal bones it is the whole bone. Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value in change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
1426952|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 24|ITT population.|||units on a scale||Full Range|Median
1426953|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT-RAMRIS Synovitis Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th MCP were assessed for synovitis via MRI and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426954|NCT01034397|Secondary|Absolute Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.|||units on a scale||Full Range|Median
1426955|NCT01034397|Secondary|Percent Change From Baseline to Week 24 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score + Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 24|ITT population; participants from the placebo group who did not show an improvement of ≥20% in TJC and SJC were offered recovery therapy with tocilizumab 8 mg/kg and were placed in Placebo-Tocilizumab 8 mg/kg group.|||percent change||Full Range|Median
1426956|NCT01034397|Secondary|Absolute Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||units on a scale||Full Range|Median
1426957|NCT01034397|Secondary|Percent Change From Baseline to Week 12 in OMERACT RAMRIS Score|RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema scored 0 (normal) to 69 (maximum articular bone involvement). Erosion scored from 0 (normal) to 230 (maximum erosion of articular bone). RAMRIS=Synovial Score plus (+) Edema Score + Erosion Score. Minimum RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number=increasing severity.|Week 12|ITT population. After Week 12, participants receiving placebo could have been switched to tocilizumab.|||percent change||Full Range|Median
1426958|NCT01034397|Primary|Percent Change From Baseline to Week 12 in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score|Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Three wrist regions (distal radioulnar joint, radiocarpal joint, the intercarpal and intermetacarpal joint) and the 2nd to 5th metacarpophalangeal (MCP) were assessed for synovitis via magnetic resonance imaging (MRI) and scored using a scale ranging from 0-3 where 0 is normal and scores 1-3 (mild, moderate, severe) are by thirds of the presumed volume of enhancing tissue in the synovial compartment. These values were then summed yielding scores of 0-9 in the wrist region, 0-12 for MCP joints, and 0-22 on the aggregate. A negative value in synovitis change from Baseline score indicates an improvement.|Week 12|ITT population; n (number) equals (=) number of participants assessed for the specified parameter|||percent change||Full Range|Median
1426959|NCT01034358|Primary|Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])|Anti-HPV levels were determined by an assay conducted by Merck & Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).|One year||||mMU/mL||95% Confidence Interval|Geometric Mean
1426960|NCT01034306|Secondary|ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters||12 weeks|||||||
1426961|NCT01034306|Secondary|Safety: Adverse Event Reporting, Physical Examination, Vital Signs, Clinical Laboratory Testing||12 weeks|||||||
1426962|NCT01034306|Primary|American College of Rheumatology (ACR20)|Primary efficacy was assessed using ACR20 response at Week 12, with all-cause dropouts considered as non-responders, in the ITT population.|12 weeks||||participants|||Number
1426963|NCT01034176|Secondary|Number of Patients With >50% Reduction in BK Virus Copies|Number of patients with >50% reduction in BK viral load at 6 months|Baseline and 6 months|number of patients with >50% reduction in BK viral load at 6 months|||participants|||Number
1426964|NCT01034176|Primary|Percent Change From Baseline in BK Virus Copies at 3 Months|Percent change in BK virus copies/mL from Baseline to 3 months|Baseline and 3 months||||Percent change of BK virus copies||Standard Deviation|Median
1440977|NCT00928018|Secondary|To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms||6 months||||percentage of participants|||Number
1426966|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 104|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
1426967|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 52|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 52|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
1426968|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 24|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 24|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
1426969|NCT01034137|Secondary|Number of Participants With Clinically Significant Laboratory Values at Week 12|Laboratory parameters included hematology, chemistry and lipids. Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy was considered clinically significant. Participants with clinically significant laboratory values are reported in the below table.|Week 12|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
1426970|NCT01034137|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Adverse Events Leading to Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), lifethreatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Up to Week 104|The safety population consisted of all participants who received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and have at least one post-baseline safety assessment.|||Number of participants|||Number
1426971|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 104|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426972|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 52|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 52|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1427032|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 8|Not all participants answered every question|||percentage of participants|||Number
1426973|NCT01034137|Secondary|Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 24|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 24|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426974|NCT01034137|Secondary|Mean Change From Baseline in The Revised Illness Perception Questionnaire (IPQ-R) Score of Quality of Life at Week 12|The IPQ-R includes 9 domains (identity, acute or chronic timeline, consequences, personal and treatment control, illness coherence, timeline cyclical, emotional representations, and cause). For first 8 domains it scores as: 1(strongly disagree), 2(disagree), 3(neither agree/disagree), 4(agree), and 5(strongly agree), except identity as 1(yes) and 0(no). The sum of scores for identity, timeline, consequences, and cyclical domains are ranged from 0-16. High score represent strongly held beliefs about the number of symptoms attributed to RA, the chronicity of the condition, the negative consequences of the illness and the cyclical nature of the condition. The sum of scores for personal and treatment control, coherence dimensions, and emotional representations are ranged from 0-15. High score represent positive beliefs about the number of controllability of RA and a personal understanding of the condition. The data for ‘Cause’ domain was not considered for analysis in this study.|From Baseline (Week 0) to Week 12|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426975|NCT01034137|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Score of Quality of Life at Weeks 12, 24, 52, and 104|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participants response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant’s response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant’s health status.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426976|NCT01034137|Secondary|Mean Change From Baseline in Patient General Wellbeing Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their general wellbeing using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as  not active at all  and the right-hand extreme equals 10 as  very active  .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426977|NCT01034137|Secondary|Mean Change From Baseline in Patient Pain Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain .The final VAS score will be derived by multiplying the original scores by 10."|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426978|NCT01034137|Secondary|Mean Change From Baseline in Physician Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Physician global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Physician global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426979|NCT01034137|Secondary|Mean Change From Baseline in Patient Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104|Patient global health VAS score ranges from 0 to 100 and a higher score indicates worse QoL. Patient global health VAS is a component of DAS28.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1427015|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 4|Not all participants answered every question|||participants|||Number
1426980|NCT01034137|Secondary|Mean Change From Baseline in 36-Item Short Form Health Survey of Quality of Life at Weeks 12, 24, 52, and 104|The 36-Item Short Form Health Survey (SF-36) is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Summary (PCS) and Mental Component Summary (MCS) measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426981|NCT01034137|Secondary|Mean Change From Baseline in The EuroQol Score of Quality of Life at Weeks 12, 24, 52 and 104|"EuroQol (EQ-5D) is a standard self-completed participant questionnaire that measures health outcome. The EQ-5D questionnaire consists of 2 parts: 1) EQ-5D with five dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale as 1 = no problems, 2 = some/moderate problems, 3 = extreme problems. The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, where ‘1’ indicating full health and ‘0’ representing dead. The positive values indicate that during the study the health status improved. 2) EQ-VAS on a scale of 0 to 100, where 0 = worst possible health status and 100 = best possible health status.”"|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426982|NCT01034137|Secondary|Mean Change From Baseline in The Dutch Consensus Health Assessment Questionnaire of Quality of Life at Weeks 12, 24, 52, and 104|The Dutch Consensus Health Assessment Questionnaire (DC-HAQ) disability index is a self-completed participant questionnaire with 8 domains specific for RA. It assesses a participant functional ability, with scores ranging from 0 (without any difficulty) to 3 (unable to do). A change from baseline of –0.22 is considered to be the minimal clinically important difference.|From Baseline (Week 0) to Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Scores on a scale||Standard Deviation|Mean
1426983|NCT01034137|Secondary|Number of Participants With Change in The Therapy Strategy During The Study|Participants who switched treatment strategy from monotherapy (TCZ+ placebo MTX or MTX+ placebo TCZ treatment) to combination therapy (TCZ+MTX treatment) was reported. Also, participants who switched from verum therapy to standard of care was reported in the below table.|From Baseline to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Number of participants|||Number
1426984|NCT01034137|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (participants not responding to the drug as assessed by the physician) was selected by the investigator as a reason for the participant to withdraw from the study.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
1426985|NCT01034137|Secondary|Mean Change From Baseline in Modified Sharp/Van Der Heijde Score at Weeks 52 and 104|The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.|From Baseline (Week 0) to Weeks 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Standard Deviation|Mean
1426986|NCT01034137|Secondary|Mean Percent Change From Baseline in CRP at Weeks 12, 24, 52, and 104|CRP is a component of ACR. CRP is a marker of inflammation.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
1426987|NCT01034137|Secondary|Mean Percent Change From Baseline in Pain Visual Analog Scale at Weeks 12, 24, 52, and 104|Pain VAS is a component of ACR. VAS pain score calculated as 0 to 10 cm; where 0 = no pain, and 10 = worst possible pain.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
1426988|NCT01034137|Secondary|Mean Percent Change From Baseline in The Physician Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Physician health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).An improvement (decrease) in the physician’s global assessment based on disease activity parameter relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
1428454|NCT01022502|Secondary|Patients Preferred Ointment Type.|At the end of the trial, the patients were asked which ointment they preferred.|Week 8|Total number of participants completing the 8 week period with study intervention.|||participants|||Number
1426989|NCT01034137|Secondary|Mean Percent Change From Baseline in Patient Health Visual Analog Scale at Weeks 12, 24, 52, and 104|Patient health visual analog scale is a component of ACR. It is measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity). An improvement (decrease) in the patient’s global assessment based on disease activity relative to respective baseline values was analyzed.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment|||Percent change||Standard Deviation|Mean
1426990|NCT01034137|Secondary|Mean Percent Change From Baseline in the Tender Joint Count (TJC) at Weeks 12, 24, 52, and 104|The number of tender joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a tender joint was scored as 1 and absence as 0. The total TJC was derived by the sum of the scores for a range of TJC from 0 (best possible score; no tender joints) to 44 (worse possible score; all tender joints).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
1426991|NCT01034137|Secondary|Mean Percent Change From Baseline in the Swollen Joint Count (SJC) at Weeks 12, 24, 52, and 104|The number of swollen joints among 22 anatomical joints for both the right and left side of the body were assessed by a joint evaluator where the presence of a swollen joint was scored as 1 and absence as 0. The total SJC was derived by the sum of the scores for a range of SJC from 0 (best possible score; no swollen joints) to 44 (worse possible score; all joints swollen).|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percent change||Standard Deviation|Mean
1426992|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 90 Response Rate at Weeks 12, 24, 52 and 104|ACR90 response is defined as a >=90% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or erythrocyte sedimentation rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
1426993|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 70 Response Rate at Weeks 12, 24, 52 and 104|ACR70 response is defined as a >=70% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient’s Assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
1426994|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 50 Response Rate at Weeks 12, 24, 52 and 104|ACR50 response is defined as a >=50% improvement (reduction) compared with baseline for both TJC68 and SJC66, as well as for three of the additional five ACR core set variables: patient’s assessment of pain over the previous 24 hours: using a VAS with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s Global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
1426995|NCT01034137|Secondary|Percentage of Participants With American College of Rheumatology 20 Response Rate at Weeks 12, 24, 52 and 104|American College of Rheumatology (ACR) 20 response is defined as a >= 20% improvement (reduction) compared with baseline for both tender joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: patient’s assessment of pain over the previous 24 hours: using a Visual Analog Scale (VAS) with left end of the line 0=no pain to right end of the line 100=unbearable pain; patient’s global assessment of disease activity and physician’s global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Weeks 12, 24, 52 and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
1426996|NCT01034137|Secondary|Median Time to First European League Against Rheumatism Response|It is the time to first EULAR response. EULAR response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant’s DAS28 as the measure of severity of disease.Good or moderate response is defined as follows: Good response : DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2. Response 1 is defined as yes (good) versus no (moderate or no response). Response 2 is defined as yes (good or moderate) versus no (no response).|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Days||Inter-Quartile Range|Median
1426997|NCT01034137|Secondary|Number of Participants With Good European League Against Rheumatism Response Rate at Weeks 24, 52, and 104|European league against rheumatism (EULAR) response criteria classify each participant as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual participant’s DAS28 as the measure of severity of disease. Good or moderate response is defined as follows: Good response : DAS28 at the time point =<3.2 and improvement from baseline > 1.2. Moderate response : DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and =<1.2.|Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
1426998|NCT01034137|Secondary|Median Change From Baseline in Simplified Disease Activity Index Scores at Weeks 24, 52, and 104|The simplified disease activity index (SDAI ) are continuous measures of RA disease activity.The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm VAS), and C-Reactive Protein (CRP) (mg/dL). SDAI total score ranges from 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Full Range|Median
1426999|NCT01034137|Secondary|Median Change From Baseline in Clinical Disease Activity Index Score at Weeks 24, 52, and 104|The clinical disease activity index (CDAI) are continuous measures of RA disease activity. The CDAI is the numerical sum of four outcome parameters: tender joint count (TJC), swollen joint count (SJC) based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS). CDAI total score ranges from 0 to 76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|From Baseline (Week 0) to Weeks 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Full Range|Median
1427000|NCT01034137|Secondary|Absolute Change From Baseline in Disease Activity Score 28 at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the participant’s disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|From Baseline (Week 0) to Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Scores on a scale||Full Range|Median
1427001|NCT01034137|Secondary|Mean Duration of First Disease Activity Score 28 Remission|It is the duration of the first period of DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Weeks||Standard Deviation|Mean
1427002|NCT01034137|Secondary|Percentage of Participants With Cumulative Remission Rate at Weeks 12, 24, 52, and 104|The DAS28 score is a measure of the subject's disease activity. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Percentage of participants|||Number
1427003|NCT01034137|Secondary|Median Time to First Disease Activity Score 28 Remission|It is the time to event analysis for the first DAS28 remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||Days||95% Confidence Interval|Median
1427016|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 24|Not all participants answered every question|||percentage of participants|||Number
1440978|NCT00928018|Secondary|To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms||2 years||||percentage of participants||95% Confidence Interval|Number
1427004|NCT01034137|Secondary|Number of Participants Achieving Disease Activity Score 28 Remission at Weeks 12, 24, 52, and 104|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission. Participants with missing data at visits before early study termination or who stopped the study prematurely because of insufficient therapeutic response or safety reasons considered non-responders or who stopped the study for other reasons, response set to missing after early withdrawal.|Weeks 12, 24, 52, and 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Number of participants|||Number
1427005|NCT01034137|Secondary|Mean Duration of First Sustained Remission|It is the duration of the first period of sustained DAS28 remission. Participants who switch treatment strategy before reaching sustained remission considered failures.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement. n = number of participants evaluable at particular time of assessment.|||Weeks||Standard Deviation|Mean
1427006|NCT01034137|Secondary|Median Time to First Sustained Remission|It is the time to event analysis for the first period of sustained remission. Sustained remission is defined as DAS28 <2.6 during ≥23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts (range 0-28), acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Up to Week 104|The ITT population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsule and performed at least one post-baseline efficacy measurement.|||days||95% Confidence Interval|Median
1427007|NCT01034137|Primary|Percentage of Participants Achieving Sustained Remission Rate At Week 104|Sustained remission rate (SRR) is defined as Disease Activity Score 28 (DAS28) <2.6 during ≥ 23 weeks and no more than 4 swollen joints (28 joint count) due to RA at Week 24 of remission, with the exception of up to 2 in-between DAS28 values which could be between 2.6 and 3.2. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 104|The intent to treat (ITT) population consisted of all participants who were randomized and received at least one dose of TCZ/placebo infusion or MTX/placebo capsules and performed at least one post-baseline efficacy measurement.|||Percentage of participants|||Number
1427008|NCT01034111|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 4|Calculated as the mean change from baseline in fasting plasma glucose at Week 4.|Baseline and Week 4||||mmol/L||Standard Deviation|Mean
1427009|NCT01034111|Primary|Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment|Safety & tolerability were measured in terms of the # of participants with >=1 adverse event (AE), >=1 drug-related AE, >=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR’s product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator.|4 weeks||||Participants|||Number
1427010|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 24|Not all participants answered every question|||participants|||Number
1427011|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 20|Not all participants answered every question|||participants|||Number
1427012|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 16|Not all participants answered every question.|||participants|||Number
1427013|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Week 12|Not all participants answered every question.|||participants|||Number
1427017|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 20|Not all participants answered every question|||percentage of participants|||Number
1427018|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 16|Not all participants answered every question|||percentage of participants|||Number
1427019|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been on this study.”|Week 12|Not all participants answered every question|||percentage of participants|||Number
1427020|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 8|Not all participants answered every question|||percentage of participants|||Number
1427021|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I have already risked getting infected with HIV through unsafe sex while I’ve been in this study.”|Week 4|Not all participants answered every question|||percentage of participants|||Number
1427022|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 24|Not all participants answered every question|||percentage of participants|||Number
1427023|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 20|Not all participants answered every question|||percentage of participants|||Number
1427024|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 16|Not all participants answered every question|||percentage of participants|||Number
1427025|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 12|Not all participants answered every question|||percentage of participants|||Number
1427026|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 8|Not all participants answered every question|||percentage of participants|||Number
1427027|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am less concerned about having unprotected anal sex now that I am in this PrEP study.”|Week 4|Not all participants answered every question|||percentage of participants|||Number
1427028|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 24|Not all participants answered every question|||percentage of participants|||Number
1427029|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 20|Not all participants answered every question|||percentage of participants|||Number
1427030|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 16|Not all participants answered every question|||percentage of participants|||Number
1427031|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 12|Not all participants answered every question|||percentage of participants|||Number
1427033|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “The availability of PrEP makes me less worried about having unprotected sex.”|Week 4|Not all participants answered every question|||percentage of participants|||Number
1427034|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 24|Not all participants answered every question|||percentage of participants|||Number
1427035|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 20|Not all participants answered every question|||percentage of participants|||Number
1427036|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 16|Not all participants answered every question|||percentage of participants|||Number
1427037|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 12|Not all participants answered every question|||percentage of participants|||Number
1427038|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 8|Not all participants answered every question|||percentage of participants|||Number
1427039|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex|Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: “I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex.”|Week 4|Not all participants answered every question|||percentage of participants|||Number
1427040|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 24|Not all participants answered every question|||percentage of participants|||Number
1427041|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 20|Not all participants answered every question|||percentage of participants|||Number
1427042|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 16|Not all participants answered every question|||percentage of participants|||Number
1427043|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 12|Not all participants answered every question|||percentage of participants|||Number
1427044|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 8|Not all participants answered every question|||percentage of participants|||Number
1427045|NCT01033942|Primary|Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study."|Week 4|Not all participants answered every question|||percentage of participants|||Number
1427046|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 24|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 24|Not all participants answered every question|||percentage of participants|||Number
1427047|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 20|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 20|Not all participants answered every question|||percentage of participants|||Number
1440979|NCT00928018|Secondary|To Compare 2-year Progression-free Survival Between the Two Treatment Arms||2 years||||percentage of participants||95% Confidence Interval|Number
1427049|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 12|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 12|Not all participants answered every question|||percentage of participants|||Number
1427050|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 8|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 8|Not all participants answered every question|||percentage of participants|||Number
1427051|NCT01033942|Primary|Perceived Risk of Becoming HIV Positive at Week 4|"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive."|Week 4|Not all participants answered every question|||percentage of participants|||Number
1427052|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24||Week 24|Not all participants answered every question|||participants|||Number
1427053|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20||Week 20|Not all participants answered every question|||participants|||Number
1427054|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16||Week 16|Not all participants answered every question|||participants|||Number
1427055|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12||Week 12|Not all participants answered every question|||participants|||Number
1427056|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8||Week 8|Not all participants answered every question|||participants|||Number
1427057|NCT01033942|Primary|Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4||Week 4|Not all participants answered every question|||participants|||Number
1427058|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427059|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Ran Out of Study Pills||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427060|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427061|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Felt Sick or Ill||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427062|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427063|NCT01033942|Primary|Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427064|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427065|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427066|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427067|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take||24 weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427068|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Simply Forgot||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427069|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1427070|NCT01033942|Primary|Frequency of Missing Study Pills Because Participant Was Away From Home||24 Weeks|Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason.|||% of participants in each category|||Number
1442560|NCT00915551|Primary|Complete Clearance of Actinic Keratoses (AK) Lesions|Complete clearance of the treatment field|baseline and 57 days|Intention to treat population|||participants|||Number
1427071|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 24|No subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 24. 10 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 24.|||percentage of participants|||Number
1427072|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 20|One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 20. 12 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 20.|||percentage of participants|||Number
1427073|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 16|13 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 16. 13 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 14 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 16.|||percentage of participants|||Number
1427074|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 12|One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 12. 15 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 1 subject in the No Pill arm had tenofovir plasma concentration testing at Week 12.|||percentage of participants|||Number
1427075|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 8|18 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 8. 17 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 17 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 8.|||percentage of participants|||Number
1427076|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Week 4|Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 4. 19 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 4.|||percentage of participants|||Number
1427077|NCT01033942|Primary|Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline|Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count.|Baseline|Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at baseline. All subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at baseline.|||percentage of participants|||Number
1427078|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Overall|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|20 Weeks||||Missed doses||Full Range|Median
1427079|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 20|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 20||||Missed doses||Full Range|Median
1427080|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 16|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 16||||Missed doses||Full Range|Median
1427081|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 12|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 12||||Missed doses||Full Range|Median
1427082|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 8|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 8||||Missed doses||Full Range|Median
1427083|NCT01033942|Primary|Number of Missed Doses Based on Medication Refill Dates-Week 4|Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 4||||Missed doses||Full Range|Median
1427084|NCT01033942|Primary|Number of Missed Doses Over Time Based on Self-Report Calendar Data|The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits.|24 weeks||||Doses||Standard Error|Least Squares Mean
1427102|NCT01033942|Primary|Acceptability of the Taste of the Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427085|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 24|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 24||||Missed Doses||Full Range|Median
1427086|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 20|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 20||||Missed Doses||Full Range|Median
1427087|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 16|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 16||||Missed Doses||Full Range|Median
1427088|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 12|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 12||||Missed Doses||Full Range|Median
1427089|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 8|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|Week 8||||Missed Doses||Full Range|Median
1427090|NCT01033942|Primary|Number of Missed Doses Based on Self-Report Calendar Data-Week 4|Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days.|4 weeks||||Missed Doses||Full Range|Median
1427091|NCT01033942|Primary|Acceptability of Health Clinic for Study Visits||Week 24|Not all participants answered every question.|||participants|||Number
1427092|NCT01033942|Primary|Acceptability of Physical Examination by a Doctor||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427093|NCT01033942|Primary|Acceptability of Being Contacted by the Research Team in Between Visits||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427094|NCT01033942|Primary|Acceptability of Questions About Sexual Behavior at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427095|NCT01033942|Primary|Acceptability of Risk Reduction Counseling at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427096|NCT01033942|Primary|Acceptability of Having an HIV Test at Every Visit||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427097|NCT01033942|Primary|Acceptability of Being Randomly Assigned to a Group||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427098|NCT01033942|Primary|Acceptability of Participating in Group Sessions||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427099|NCT01033942|Primary|Acceptability of Taking Part in the Study||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427100|NCT01033942|Primary|Acceptability of Taking the Pill Everyday||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427101|NCT01033942|Primary|Acceptability of the Color of the Pill||Week 24|Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed.|||participants|||Number
1427104|NCT01033942|Secondary|Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline|"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?"|Baseline||||participants|||Number
1427105|NCT01033942|Primary|Actual Number of Study Visits Completed by 24 Weeks|This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.|24 weeks||||Visits||Standard Error|Least Squares Mean
1427106|NCT01033864|Secondary|Regression Coefficients For Participants Receiving MMF|The estimated regression coefficients for participants who received MMF presented in milligrams per liter (mg/L).|Day 1 at 30 minutes and 1 and 2 hours postdose|PK population. Only participants in the MMF/Prednisone group were assessed for this outcome measure, n=12.|||mg/L|||Number
1427107|NCT01033864|Primary|Percentage of Participants By Time to Maximum Plasma Concentration (Tmax)||Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||percentage of participants|||Number
1427108|NCT01033864|Primary|Dose-Normalized MPA AUC0-12|"Dose-normalized MPA AUC0-12 in plasma was determined (mg*h/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/1000) For the EC-MPS group: Dose normalized MPA AUC = MPA AUC / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg*h/L||Standard Deviation|Mean
1427109|NCT01033864|Primary|MPA Area Under the Curve From 0 to 12 Hours (AUC0-12)|The mean MPA AUC0-12 in plasma was determined (in mg multiplied by hours, per Liter [mg*h/L]) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg*h/L||Standard Deviation|Mean
1427110|NCT01033864|Primary|Dose-Normalized Cmax (mg/L)|"Dose-normalized Cmax in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmax = Cmax / (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmax = Cmax / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
1427111|NCT01033864|Primary|Maximum Plasma Concentration (Cmax)|The mean maximum MPA concentration in plasma was determined (in mg/L) in blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
1427112|NCT01033864|Primary|Dose-Normalized Cmin|"Dose-normalized Cmin was determined (in mg/L) from blood samples collected predose and postdose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized Cmin = Cmin/ (actual dose taken/1000) For the EC-MPS group: Dose normalized Cmin = Cmin / (actual dose taken/720)"|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
1427113|NCT01033864|Primary|Minimum Plasma Concentration (Cmin)|The mean minimum MPA concentration in plasma was determined (in mg/L) from blood samples collected predose and postdose on Day 1.|Day 1 predose and postdose at 30 and 60 minutes and 2, 3, 4, 5, 6, 8 10 and 12 hours|PK population|||mg/L||Standard Deviation|Mean
1427114|NCT01033864|Primary|Dose-Normalized C0|"Dose normalized C0 was determined (in mg/L) from blood samples collected predose. Both MMF and EC-MPS doses were normalized to a standard dose of 1 g MMF or 720 mg EC-MPS, respectively. The dose normalization was calculated as follows:~For the MMF group: Dose normalized C0 equals (=) C0 divided by (/) (actual dose taken/1000) For the EC-MPS group: Dose normalized C0 = C0 / (actual dose taken/720)"|Day 1 predose|PK population|||mg/L||Standard Deviation|Mean
1427115|NCT01033864|Primary|Pre-dose Trough Concentration (C0)|The mean mycophenolic acid (MPA) concentration in plasma was determined (in milligrams per liter [mg/L]) from blood samples collected predose (immediately before receiving study treatment).|Day 1 predose|Pharmacokinetic (PK) population: all participants who took study drug and for whom all defined blood samples at the planned sampling time points were available.|||mg/L||Standard Deviation|Mean
1427116|NCT01033851|Secondary|Clinical Global Impression of Severity (CGIS) of Anxiety Symptoms.|This is an overal clinical measure of anxiety symptoms after examining and interviewing the patient. The scale is one global item, that scores from 1 (1= not ill at all) to 7 (7= among the most extremely ill).|2 months|The population analyzed included all participants attending at least one class of an intervention.|||units on a scale||Standard Deviation|Mean
1427117|NCT01033851|Primary|Active Symptoms of Generalized Anxiety Disorder|The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.|2 months|The population analyzed included all participants who attended at least one class of an intervention.|||units on a scale||Standard Deviation|Mean
1427118|NCT01033825|Secondary|Percentage of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population|||percentage of devices|||Number
1427119|NCT01033825|Secondary|Number of Devices With Major Discrepancies|A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration.|Week 6|Intent to Treat Population|||Devices|||Number
1427120|NCT01033825|Secondary|Percentage of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population|||percentage of devices|||Number
1427121|NCT01033825|Secondary|Number of Devices With Actuation Consistency|Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration.|Weeks 1-4|Intent to Treat Population|||Devices|||Number
1427123|NCT01033825|Secondary|Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately.|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||Number of days|||Number
1427124|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427125|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427126|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427127|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427128|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427129|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Instantaneous NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427130|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427131|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM and PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427151|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Error|Least Squares Mean
1427132|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427133|NCT01033825|Primary|The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period|Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|week 6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Error|Least Squares Mean
1427134|NCT01033825|Secondary|Baseline Daily Subject-reported Individual PM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427135|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427136|NCT01033825|Secondary|Baseline Daily Subject-reported Individual AM Reflective NSS|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427137|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427138|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427139|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427140|NCT01033825|Secondary|Baseline Daily Subject-reported PM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427141|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427142|NCT01033825|Secondary|Baseline Daily Subject-reported AM and PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427143|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427144|NCT01033825|Secondary|Baseline Daily Subject-reported AM Instantaneous TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427145|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427146|NCT01033825|Secondary|Baseline Daily Subject-reported PM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427147|NCT01033825|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Error|Least Squares Mean
1427148|NCT01033825|Secondary|Baseline Daily Subject-reported AM Reflective TNSS|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||units on a scale||Standard Deviation|Mean
1427149|NCT01033825|Secondary|Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment||Weeks 0-6|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Error|Least Squares Mean
1427150|NCT01033825|Secondary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline||Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Deviation|Mean
1427161|NCT01033825|Primary|Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline|AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE).|Baseline|Per Protocol Population. Analysis does not include the subjects that received Dexamethasone during the active control period.|||mcg•h/dL||Standard Deviation|Mean
1427162|NCT01033747|Secondary|Relative Change in Serum Ferritin From Baseline to 3.5 Years|The mean percentage change in serum ferritin was evaluated by comparing the serum ferritin level at the start of Deferasirox treatment to the serum ferritin level collected 18 months following the start of the extension study. Serum ferritin is measured in micrograms per Liter. Relative Change = 1- (Change in ferritin level from Baseline/Baseline level) x 100.|Baseline to 3.5 years|All participants comprised of the full analysis set were evaluated for the change in serum ferritin.|||Percent change||Full Range|Mean
1427163|NCT01033747|Primary|The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox|The mean percentage change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of Deferasirox treatment to the LIC at the end of the 5 year extension study for participants who were treated with Deferasirox for more than 3.5 years. LIC is expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). Relative change = 1- (Change in LIC from Baseline/Baseline level) x 100.|Baseline to 7 Years|All participants in the full analysis set treated with deferasirox for more than 3.5 years.|||Percent change||Full Range|Mean
1427164|NCT01033734|Secondary|Participants With Greater Than or Equal to (>=) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values|IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either >=5 times change in the NAI IC50 visit value from the Reference value at a visit, >=5 times change in the NAI IC50 Visit value from the Baseline value.|Baseline, Day 1, 6 and 30|Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.|||Participants|||Number
1427165|NCT01033734|Secondary|Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not collected because of changes in planned analysis, due to early study termination.||||||
1427166|NCT01033734|Secondary|Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.||||||
1427167|NCT01033734|Secondary|Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|Data not available as no participant was evaluable for specified time-points.||||||
1427168|NCT01033734|Secondary|Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
1427169|NCT01033734|Secondary|Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427170|NCT01033734|Secondary|Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.|||hours||Geometric Coefficient of Variation|Geometric Mean
1427171|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427172|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427173|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427174|NCT01033734|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428827|NCT01020487|Primary|Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)||Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|All participants enrolled and administered paricalcitol for the pharmacokinetic (PK) period, Part 1|||ng/mL||Standard Deviation|Mean
1427175|NCT01033734|Primary|Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1427176|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5||Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427177|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4||Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427178|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3||Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427179|NCT01033734|Primary|AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2||Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion|PK population. Number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1427180|NCT01033734|Primary|Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1||Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.|Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.|||hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1427181|NCT01033565|Primary|Clinical Global Impression-Improvement|Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.|2 weeks||||units on a scale|||Number
1427182|NCT01033487|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally. Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in IC was the difference between IC and baseline IC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
1427183|NCT01033487|Secondary|Change From Baseline in Force Vital Capacity (FVC)|FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period. Change from baseline in FVC was the difference between FVC and baseline FVC.|Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
1427184|NCT01033487|Secondary|Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5. Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 24.5 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
1427185|NCT01033487|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Peak FEV1 was defined as change from baseline in maximum FEV1. Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose. Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.|Baseline up to 48 hrs post-dose|FAS population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
1427186|NCT01033487|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.||||||
1427187|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞). AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.||||||
1427188|NCT01033487|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It was obtained from AUC (0 - t) plus AUC (t-∞).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Data was not analyzed because a well characterized terminal phase was not observed for the parameter.||||||
1427189|NCT01033487|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||(pg*hr/mL)/mcg||Standard Deviation|Geometric Mean
1429036|NCT01017237|Primary|Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|Per protocol|||percentage of patients|||Number
1427190|NCT01033487|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||pg*hr/mL||Standard Deviation|Geometric Mean
1427191|NCT01033487|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||hr||Full Range|Median
1427192|NCT01033487|Primary|Dose Normalized Maximum Observed Plasma Concentration|Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).|1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||(pg/mL)/mcg||Standard Deviation|Geometric Mean
1427193|NCT01033487|Primary|Maximum Observed Plasma Concentration (Cmax)||1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||Picogram/milliliter (pg/mL)||Standard Deviation|Geometric Mean
1427194|NCT01033487|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)|FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath. Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose. Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period. Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.|Baseline, 24, 24.5 hrs post-dose|Full Analysis Set (FAS) population included all randomized participants and who had received at least one dose of randomized treatment.|||Liter||Standard Deviation|Mean
1427195|NCT01033448|Secondary|Percentage of Participants With Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 96|All enrolled participants were analyzed|||Percentage of Participants|||Number
1427196|NCT01033448|Primary|SVR Rates in Genotype 2 and 3.|Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.|Week 72|Participants with CHC Genotype 2 & 3 at week 72.|||Percentage of participants||95% Confidence Interval|Number
1427197|NCT01033448|Primary|Sustained Viral Response (SVR) Rates in CHC Genotype 1|Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.|Week 96|Participants with CHC genotype 1 at Week 96|||Percentage of participants||95% Confidence Interval|Number
1427198|NCT01033448|Primary|End of Treatment Response in Genotype 2 and 3|End of treatment response rate at Week 48 was reported for genotype 2 and 3.|Week 48|Participants with CHC Genotype 2 and 3 at Week 48.|||Percentage of Participants|||Number
1427199|NCT01033448|Primary|End of Treatment Response Rate at Week 72 in Genotype 1|End of treatment response rate at Week 72 was reported for genotype 1.|Week 72|Participants with genotype 1 CHC at Week 72.|||Percentage of Participants|||Number
1427200|NCT01033383|Secondary|Not Growth|The number of not growth, these include no growth, growth <100,000 CFU/ml, growth >100,000 CFU/ml but no WBCs, and mixed flora.|one month|The analysis population were those with completed labs data.|||urine cultures and urinalyses|Participants||Number
1427201|NCT01033383|Secondary|Other Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with other bacteriuria plus any white blood cells (WBCs) >100,000 colony that include: Proteus, Klebsiella, Enterococcus, beta-hemolytic Streptococci, viridans Streptococci, and organella morganii, Citrobacter freundii, and coagulase-negative Staphylococcus.|one month|The analysis population were those with completed labs data.|||urine cultures and urinalyses|Participants||Number
1427202|NCT01033383|Primary|E.Coli Bacteriuria Plus Pyuria|The number of urine cultures and urinalyses (obtained weekly) found with >100,000 CFU/ml growth of E.coli and >10 WBC.|One month|The analysis population were those with completed labs data.|||urine cultures and urinalyses|Participants||Number
1427203|NCT01033227|Secondary|Secondary End Point|a) reduced the duration and intensity of pain; b) reduced total narcotic analgesic consumption; and c) reduced length of hospitalization.|48 hours|Data were *not collected* and the Outcome was never analyzed, study terminated||||||
1427204|NCT01033227|Primary|48 Hour Sodium Nitrite Infusion Safety as Determined by Number of Participants With No Adverse Events|The primary end points will be to determine if a) a 48-hour sodium nitrite infusion is tolerated without a decrease in mean arterial blood pressure by 15mmHg for greater than 2 hours or development of methemoglobin greater than 5% and b) a 48-hour sodium nitrite infusion is safe as determined by monitoring for adverse events|48 hours from start of infusion||||Participants|||Count of Participants
1427205|NCT01033136|Primary|Change in PDSS Scores Over Time for MCET-V and CPT Groups|The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.|Baseline, 1-week post, and 3-month follow-up||||units on a scale||Standard Deviation|Mean
1427206|NCT01033136|Primary|Rate of Decrease in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups|The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.|Baseline, 1-week post-treatment and 3-month follow-up||||units on a scale||Standard Deviation|Mean
1427229|NCT01033019|Primary|Clinical Evaluation of sBCCs Tumors|The clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|Day 43|Efficacy analysis set: the efficacy analysis set included all randomized participants with evaluable data.|||Participants|||Number
1427207|NCT01033071|Secondary|Percent of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline and Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve both a clinic diastolic and systolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg AND less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Diastolic and systolic blood pressure is based on the arithmetic mean of the non-missing values of the 3 serial trough sitting blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||percent of participants|||Number
1427208|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Diastolic Blood Pressure of <90 mm Hg and/or Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the arithmetic mean of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||percentage of participants|||Number
1427209|NCT01033071|Secondary|Percentage of Participants Who Reached Target Clinic Systolic Blood Pressure of <140 mm Hg and/or Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the arithmetic mean of the non-missing values of the 3serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||percentage of participants|||Number
1427210|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427211|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure During Each Hour of the 24-hour Ambulatory Blood Pressure Monitoring.|The change from baseline for each hour interval of the 24-hour ambulatory blood pressure monitoring measured at week 12 or final visit. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each hour.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427212|NCT01033071|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427213|NCT01033071|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing by Ambulatory Blood Pressure Monitoring.|The change in the mean 12 hour systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427214|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427215|NCT01033071|Secondary|Change From Baseline in Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in the mean nighttime (12am to 6am) systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Mean nighttime is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427216|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427217|NCT01033071|Secondary|Change From Baseline in Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive).|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427218|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427219|NCT01033071|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 12 or final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427220|NCT01033071|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427221|NCT01033071|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 12 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427222|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure.|The change in sitting trough clinic diastolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average (arithmetic mean) of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4, Week 8 and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427223|NCT01033071|Secondary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at each week indicated relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427224|NCT01033071|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in sitting trough clinic systolic blood pressure measured at week 12 or final visit relative to baseline. Trough blood pressure is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 12.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1427225|NCT01033032|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)|||participants|||Number
1427226|NCT01033032|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 6 weeks until treatment discontinuation, expected average of 18 months|Includes patients treated at the MTD (Dose Level 3)|||months||95% Confidence Interval|Median
1427227|NCT01033032|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs)|every 6 weeks until treatment discontinuation, expected average 18 months|Includes patients treated at the MTD (Dose Level 3)|||participants|||Number
1427228|NCT01033032|Primary|Progression-free Survival (PFS)|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 6 weeks until progressive disease|Includes patients treated at the MTD (Dose Level 3)|||months||95% Confidence Interval|Median
1427241|NCT01032889|Secondary|Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.|||mm||95% Confidence Interval|Least Squares Mean
1427230|NCT01032993|Secondary|Percentage of Participants With Adverse Effects|serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.|4 weeks|3 serious adverse events occurred during the study that were judged unrelated to the study: specifically, 3 participants were hospitalized prior to randomization, 1 for pneumonia; 1 for a back injury; and 1 for a mental health condition. All recovered. There were no SAE during the randomization period. Non serious AEs are listed below.|||% of participants reporting|||Number
1427231|NCT01032993|Secondary|Percentage of Participants With Improvement in Disability Related to Muscle Pain|Disability improvement was based on patient report of improvement they felt was meaningful to them|4 weeks||||% reporting improved function|||Number
1427232|NCT01032993|Secondary|Continuation of Statin|Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.|4 weeks||||participants|||Number
1427233|NCT01032993|Primary|Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use|Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10|4 weeks||||% of participants with pain reduction|||Number
1427234|NCT01032928|Primary|Optimal Respiratory - Swallow Phase|Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks||||percentage of swallows|||Number
1427235|NCT01032928|Secondary|Percentage of Impairment According to the Penetration-Aspiration Scale|The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Scores < 3 are considered to be normal. For the purpose of our study scores were dichotimized to normal and impaired.|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks||||percentage of swallows with impaired PAS|||Number
1427236|NCT01032928|Secondary|Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)|Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system|Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks||||percentage of impairment|||Number
1427237|NCT01032915|Secondary|Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks|The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Score||Standard Deviation|Mean
1427238|NCT01032915|Secondary|Mean Change in Best Corrected Visual Acuity From Baseline|The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score.|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Letters||Standard Deviation|Mean
1427239|NCT01032915|Secondary|Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks|Participants could have received up to 5 immunosuppresive agents (prednisone, cyclosporine, azathioprine, methotrexate, mycophenolate). Immunosuppressive Medication Score (IMS) is a combined, single numeric score derived on basis of total daily dose of specific immunosuppressive agents / unit body weight, ranged on a scale from 0-9 for the total daily dose in mg per kg. Patients receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS (or its reduction from baseline) showed better clinical outcome|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Score||Standard Deviation|Mean
1427240|NCT01032915|Primary|Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline|Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baselineRecurrence of active intermediate, posterior, or panuveitis defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters|Baseline to 24 weeks|Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and have at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they are assigned to at randomization.|||Days||95% Confidence Interval|Median
1429037|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery|Lack of recall of picture shown indicates presence of amnesia|Day of Surgery prior to discharge|per protocol|||percentage of patients|||Number
1427242|NCT01032889|Secondary|Change From Baseline in Submental Fat Volume|Submental fat volume was measured by magnetic resonance imaging (MRI).|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population; LOCF method was used to impute missing data.|||mm³||95% Confidence Interval|Least Squares Mean
1427243|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427244|NCT01032889|Primary|Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified intent-to-treat population with available Baseline data; LOCF method was used to impute missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427245|NCT01032889|Primary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Modified Intent-to-Treat (mITT) population including all randomized participants who received at least 1 injection of study drug and had at least 1 post-baseline observation for CR-SMFRS, Subject Self-Rating Scale (SSRS), or magnetic resonance imaging (MRI) volume. Last observation carried forward (LOCF) method was used to impute missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427246|NCT01032850|Secondary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 years||||months||95% Confidence Interval|Median
1427247|NCT01032850|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|5 years||||Months||95% Confidence Interval|Median
1427248|NCT01032850|Secondary|Disease Control Rate of Response (DCR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Disease control rate (DCR) is the sum of the percentages of patients achieving complete and partial responses and stable disease|6 months||||percentage of participants|||Number
1427249|NCT01032850|Primary|Number of Participants Experiencing Adverse Events|The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.|6 months||||participants|||Number
1427250|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses That Were Treated With Antibiotics|The number of participants who developed secondary illnesses due to influenza, including otitis media, bronchitis, pneumonia, or sinusitis at any time during the study which were treated with antibiotics.|Day 1 through Day 40|ITTI population|||participants|||Number
1427251|NCT01032837|Secondary|Number of Participants Who Developed Secondary Illnesses During the Study|The number of participants who developed secondary illnesses due to influenza, including four pre-defined adverse events: otitis media, bronchitis, pneumonia, or sinusitis at any time during the study.|Day 1 through Day 40|ITTI population|||participants|||Number
1427252|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Adults|Daily influenza-like symptoms (such as nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills) were recorded in a diary on a scale from 0 (absent) to 3 (severe). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'absent' or 'mild' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including adults only (>12 years old).|||hours||95% Confidence Interval|Median
1427287|NCT01032382|Secondary|Pharmacokinetic Parameter: Tmax|Pharmacokinetic Parameter: Tmax|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). On day 1, Paromomycin Alone Treatment group N = 4; WR 279,396 group N = 3.|||hr||Standard Deviation|Mean
1427288|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax|Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)|||ng/mL||Standard Deviation|Mean
1427253|NCT01032837|Secondary|Time to Alleviation of All Clinical Symptoms - Children|Daily influenza-like symptoms (such as poor appetite, irritability, low energy, nasal congestion, runny nose etc) were recorded in a diary on a scale from 0 (no problem) to 3 (major problem). A patient is considered free of all clinical influenza symptoms if all symptoms were checked as 'no problem' or 'minor problem' (i.e., symptom score ≤1). Time to alleviation of all clinical symptoms was defined as the number of hours from the first dose to the first time the patient had alleviation of all symptoms. Patients without alleviation of symptoms were censored at the last available assessment.|Day 1 to Day 40|ITTI population including children only (ages 1 - 12 years).|||hours||95% Confidence Interval|Median
1427254|NCT01032837|Secondary|Time to Resolution of Fever|Temperature was recorded by the patient in a diary twice daily for 10 days and once daily thereafter. Fever was defined as a body temperature greater than or including 37.8 degrees Celsius (or ≥ 100.04 Fahrenheit). Time to resolution of fever was defined as the total number of hours from the first dose of study medication to the first time at which temperature is ≤ 37.2 degrees Celsius and lasts at least 21.5 hours. Patients who were still febrile at the end of the study period were censored at that time.|Day 1 through Day 40|ITTI population with fever at Baseline.|||hours||95% Confidence Interval|Median
1427255|NCT01032837|Secondary|Number of Participants With Development of Oseltamivir-Resistant Influenza Virus|The last positive viral isolate from each patient was tested for reduced sensitivity to oseltamivir. Phenotypic assay was performed to determine the susceptibility of the last positive viral isolate from each patient. If required, a genotypic assay to determine the contribution of both the neuraminidase (NA) and hemagglutinin (HA) genes to decreased susceptibility was also performed.|40 days|ITTI Population|||participants|||Number
1427256|NCT01032837|Secondary|Change From Baseline in Influenza Titer Measured by Viral Culture|Influenza virus titer measured by viral culture and expressed on a Log10 scale of the 50% Tissue Culture Infective Dose (TCID50; amount of virus required to kill 50% of inoculated tissue culture cells).|Baseline, Days 2 through 15|ITTI|||Log10 TCID50||Standard Deviation|Mean
1427257|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Reverse Transcriptase Polymerase Chain Reaction|Viral shedding was measured by reverse transcriptase polymerase chain reaction (RT-PCR) from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI|||percentage of participants|||Number
1427258|NCT01032837|Secondary|Percentage of Participants With Viral Shedding by Clinic Visit as Measured by Viral Culture|Viral shedding was measured by viral culture from samples obtained from nasal and throat swabs and performed by the central laboratory.|Baseline and Days 3, 6, 8, 11, 15 and 40|ITTI|||percentage of participants|||Number
1427259|NCT01032837|Primary|Time to Cessation of Viral Shedding|The time to cessation of viral shedding was measured by viral culture and defined as the time from treatment initiation to the time of the first negative culture with no subsequent positive cultures. Any patient with a positive culture at the last sample time was censored at that time point. Median time to cessation was estimated from the Kaplan-Meier curve.|Day 1 to Day 40|ITT infected (ITTI) Population, including all patients randomized who received at least one dose of study medication with laboratory confirmation of pandemic (H1N1) 2009 influenza infection, excluding patients infected with oseltamivir-resistant influenza A H1N1 H275Y at baseline and patients not shedding virus at baseline.|||hours||95% Confidence Interval|Median
1427260|NCT01032759|Secondary|Chronic Post-surgical Pain||1 month, 3 month, 6 month|Data was not collected and therefore not analyzed.||||||
1427261|NCT01032759|Secondary|Patient Satisfaction|"Number of participants who reported very satisfied or somewhat satisfied"|48 hours|Number of participants who had this outcome reported and documented.|||participants|||Number
1427262|NCT01032759|Secondary|Hyperalgesia|Stimulation with a Von Frey hair filament at 396 mN of force will be started from outside the hyperalgesic area, where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a “painful,” “sore,” or “sharper” feeling occurs will be marked, and the distance to the incision measured. The surface area will be measured in cm2 around the surgical incision.|Within 48 h|Number of participants who had this outcome measured and documented|||cm2||Standard Deviation|Mean
1427263|NCT01032759|Secondary|Opioid Related Side Effects: Pruritus|Number of participants who experienced pruritus.|0-24 h||||participants|||Number
1427264|NCT01032759|Secondary|Opioid Related Side Effects|Number of participants with postoperative nausea and vomiting.|0-24 h||||participants|||Number
1427265|NCT01032759|Primary|24 hr Opioid Consumption||24 hr|Participants who completed the 24 hour assessment.|||mg morphine equivalents||Standard Deviation|Mean
1427266|NCT01032759|Secondary|Pain Scores|Pain score (0=no pain, 10= worst possible pain)|48 hours|Participants who completed the 48 hour assessment.|||units on a scale||Standard Deviation|Mean
1427267|NCT01032733|Secondary|Mitochondrial Function (Cox IV Subunit)|Western blot analysis was performed to determine complex content. The amount of Cox IV subunit was determined for each Reporting Group via Western Blot analysis at baseline and week 24.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. In addition, the discrepancy for the number of participants is becasue we could only obtain information on a subset of participants due to the nature of the procedure (muscule biopsy).|||fold change (ug/ml)||Standard Deviation|Mean
1427268|NCT01032733|Secondary|Knee Extension Maximum Isokinetic Strength (Weight Lifted in Kilograms).|Maximal knee extension strength using each participant’s strongest leg was measured using a Biodex. The participants were asked to develop their maximal isokinetic knee extension strength. Three trials of 5 repetitions were performed and the peak torque value was used for statistical analyses.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.|||kilograms||Standard Deviation|Mean
1427289|NCT01032382|Secondary|Paromomycin Plasma Concentrations in Children|Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children|0 and 4 hours on days 1 and 20|Children ages 5 to 17 (inclusive)|||ng/mL||Standard Deviation|Mean
1427290|NCT01032382|Secondary|Detectable Paromomycin Plasma Levels|Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults|Day 4, 7, 12, 17, 20, 28|Adults (18+ years)|||ng/mL||Standard Deviation|Mean
1427269|NCT01032733|Secondary|Short Physical Performance Battery|Scores on the Short Physical Performance Battery (SPPB) were obtained at baseline and at the 24-week post-treatment assessment visit. The SPPB consists of a 4 meter walk, repeated chair stands, and three hierarchical standing balance tests. The time to complete each of the three performance measures was assigned a categorical score based on normative data, ranging from 0 to 4. A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by adding walking speed, chair stands, and balance scores.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures.|||score on the SPPB||Standard Deviation|Mean
1427270|NCT01032733|Secondary|Body Weight|Body weight was measured under fasting conditions following voiding in the morning at baseline and at the 24-week post-treatment assessment.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so 'centered' with a baseline carried forward mechanism).|||kilograms||Standard Deviation|Mean
1427271|NCT01032733|Primary|Performance on the 400 Meter Walk|Walking speed was assessed at baseline and 24-week assessment by the 400 Meter Walk Test, during which participants were asked to complete a standard walking course at their usual pace. Participants were permitted to stop during the walk but were not allowed to sit or receive help from others and were required to complete the course in 15 minutes.|24 weeks|Change from baseline (e.g., baseline and 24 weeks) was defined as the value at time t minus the value observed at baseline for all response measures. The five imputed responses sampled from a normal distribution with the mean baseline value (so ‘centered’ with a baseline carried forward mechanism).|||meters per second||Standard Deviation|Mean
1427272|NCT01032694|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percentage of Participants|||Number
1427273|NCT01032694|Secondary|Percent Compliance With the Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Days 11-12|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percent compliance||Standard Deviation|Mean
1427274|NCT01032694|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant’s convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered ‘very convenient’ or ‘somewhat convenient’ and 0 if participant answered ‘not convenient’ or ‘not at all convenient’.|Days 11-12|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. Missing observations were not imputed. 'N' signifies the number of participants with non-missing data.|||Percentage of Participants|||Number
1427275|NCT01032538|Secondary|Oxford Knee Score||10 years postoperatively|||||||
1427276|NCT01032538|Secondary|Knee Injury and Osteoarthritis Outcome Score||10 years postoperatively|||||||
1427277|NCT01032538|Secondary|UCLA Score||Preoperative until 2 years postoperatively|||||||
1427278|NCT01032538|Secondary|Oxford Knee Score||Preoperative until 2 years postoperatively|||||||
1427279|NCT01032538|Secondary|Range of Motion||Preoperative until 2 years postoperatively||||degrees||95% Confidence Interval|Mean
1427280|NCT01032538|Primary|Knee Injury and Osteoarthritis Outcome Score|Patient relevant knee score. Validated score with 5 arms. 0-100, 100 is best.|Preoperative until 2 years postoperatively||||units on a scale||95% Confidence Interval|Mean
1427281|NCT01032382|Secondary|Number of Index Lesions Meeting Criteria for Clinical Cure During the Study|Number of study participants who meet the criteria for clinical cure (100% re-epithelialization) at specified timepoints during the study.|Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168||||Lesions meeting clinical cure criteria|||Number
1427282|NCT01032382|Secondary|Final Clinical Cure on All Lesions Independent of Subjects|"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND,~Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168||||Cured ulcerated lesions|Participants||Number
1427283|NCT01032382|Secondary|Pharmacokinetic Parameter: AUC/D|Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|Days 1 and 20|Adults (18+ years)|||hr/ML||Standard Deviation|Mean
1427284|NCT01032382|Secondary|Pharmacokinetic Parameter: Cmax/D|Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)|||1/ML||Standard Deviation|Mean
1427285|NCT01032382|Secondary|Pharmacokinetic Parameter: t(1/2)|t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years). WR 279,396 group measurements Day 1 N = 2 and Day 20 N = 4. One study participant in the Paromomycin Alone Treatment was withdrawn at Day 100.|||hr||Standard Deviation|Mean
1427286|NCT01032382|Secondary|Pharmacokinetic Parameter: Area Under the Curve (AUC)|Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama|0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20|Adults (18+ years)|||ng*hr/mL||Standard Deviation|Mean
1427291|NCT01032382|Primary|Final Clinical Cure for Index Lesions|"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,~Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168."|Initial clinical cure by day 63 and no relapse by day 168||||participants|||Number
1427292|NCT01032291|Primary|Percentage of Participants With a Response to Treatment During the Proof of Concept Period|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).~Treatment response includes both complete response and partial response.~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Analysis was not performed due to the early termination of the study."|week 9 up to week 24|Efficacy Evaluable Population. Analysis was not performed due to the early termination of the study.||||||
1427293|NCT01032291|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|TEAEs are any adverse event occurring or worsening on or after the first treatment of any study drug and within 28 days after the last dose of the last study drug received. Relation to study drug was determined by the investigator. Severity of AE is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0. Severity is a 5-point scale: 3= severe or medically significant but not life-threatening 4=life-threatening, urgent intervention required 5=death related to AE.|up to week 28|Participants who took at least one dose of study treatment.|||participants|||Number
1427294|NCT01032291|Secondary|Kaplan-Meier Estimates for Overall Survival|"Overall survival was defined as the time between randomization and death. It was intended that participants would be followed for up to 5 years following discontinuation from treatment.~Analysis was not performed due to the early termination of the study."|up to 5.5 years|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
1427295|NCT01032291|Secondary|Percentage of Participants With Disease Control|"Known as the Disease Control Rate (DCR), participants with a complete response, partial response or stable disease contribute to the DCR.~This analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
1427296|NCT01032291|Secondary|Kaplan-Meier Estimates for Duration of Response|"Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR).~Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
1427297|NCT01032291|Secondary|Kaplan-Meier Estimates for Progression Free Survival (PFS)|"PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD), or death on study due to any cause.~Analysis was not performed due to the early termination of the study."|up to week 24|Participants who took at least one dose of study treatment. Analysis was not performed due to the early termination of the study.||||||
1427298|NCT01032291|Post-Hoc|Best Overall Response Assessed by an Independent Review Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) During the Proof of Concept Period Prior to Early Study Termination|"Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions.~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir.~Participants with evidence of objective tumor response have the response confirmed with repeat assessments performed at the next scheduled scan."|Week 9 up to week 24|Intent to treat population.|||participants|||Number
1427299|NCT01032291|Primary|Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period|"The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period:~If <2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg.~If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide.~If <2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg.~If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide.~If <2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg.~If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators."|Up to Day 28 (Cycle 1)|All participants who took at least one dose of study medication. If a participant discontinued the study prior to completing the entire first cycle for reasons other than a DLT or if ≥7 days of lenalidomide and/or ≥1 dose of cetuximab were missed during the first cycle for reasons other than a DLT, a replacement would be added at that dose level.|||participants|||Number
1427300|NCT01032265|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)||4 months|Intention-to-treat|||participants|||Number
1427301|NCT01032265|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, 4 months|Intention-to-treat|||episodes per week||Standard Deviation|Mean
1427302|NCT01032265|Secondary|Patient Satisfaction||4 months|Intention-to-treat|||participants|||Number
1427303|NCT01032265|Secondary|Usage of Incontinence Aids|Only those using incontinence aids at baseline were included in the analysis.|baseline, 4 months|Intention-to-treat|||participants|||Number
1427304|NCT01032265|Secondary|EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)|health-specific quality of life, range 0-100, higher scores indicate better quality of life.|baseline, 4 months|Intention-to-treat|||units on a scale||Standard Deviation|Mean
1457372|NCT00796744|Secondary|The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.||Duration of subject's participation (24 weeks)|Safety Population|||patients|||Number
1427305|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.|baseline, 4 months|Intention-to-treat|||units on a scale||Standard Deviation|Mean
1427306|NCT01032265|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|summed symptom-score, range 0–21, with higher scores indicating greater severity.|baseline, 4 months|Intention-to-treat|||units on a scale||Standard Deviation|Mean
1427307|NCT01032239|Secondary|Healthcare Resource Utilization|Number of patients with healthcare professional contacts outside of study visits in the ITB and BMT between baseline and months 6|baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6|Intent to treat analysis.|||Participants|||Count of Participants
1427308|NCT01032239|Secondary|Therapy Satisfaction|Patients were presented with two statements (“I am satisfied with the reduction in spasticity provided by my treatment”, and “I would recommend this therapy to a friend”). They agreed, disagreed or were neutral with the statements.|month 6|Intent to treat analysis.|||Participants|||Count of Participants
1427309|NCT01032239|Secondary|Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6|"SS-QoL questionnaire is a self-assessed quality of life questionnaire specifically designed for post-stroke patients. It evaluates 49 items across 12-domains: personality, energy, language, mobility, vision, upper extremity function, thinking, mood, work/productivity, self-care, and family and social roles. Each item is rated on a 5-point Likert Scale, measuring either positive or negative response to a statement. Summary score is composed of an unweighted average of the 12 domain scores, with higher scores indicating better QoL. Total score ranges from 1 to 5. Change in SS-QoL summary score from baseline to month 6 between ITB and BMT arm was assessed.~Change=SS-QoL score at month 6 - SS-QoL score at baseline."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1427310|NCT01032239|Secondary|Change in SF-12 (12-item Short Form) From Baseline to Month 6|The SF-12 is generic assessment of health-related quality of life, which evaluates 8 health dimensions (physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, mental health, and general health). Subscale scores for each dimension were aggregated into summary scores for physical (PCS) and mental health (MCS) components (ranging from 0 to 100, with higher scores indicating better health). Changes in the PCS and MCS from baseline to Month 6 were both compared between the BMT and ITB arms. Change=SF-12 score at month 6 - SF-12 score at baseline.|Baseline and month 6|"Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.~SF-12 assessment has been introduced later in a second version of the protocol, hence the lower number of patients."|||units on a scale||Standard Deviation|Mean
1427311|NCT01032239|Secondary|Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6|The EQ-5D-3L is a generic measure of health status consisting in the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system is characterized on five dimensions: mobility, self-care, ability to undertake usual activities, pain and anxiety/depression. Patients were asked to indicate their level of health on each dimension using one of three levels: “no health problems”, “moderate health problems”, and “severe health problems”. Responses from the questionnaire were converted to a single health index utility score; this ranges from -0.595 to 1. EQ VAS records the patient’s self-rated health on a vertical visual analogue scale from 0 to 100 where the endpoints are labelled ‘Best imaginable health state’ (100) and ‘Worst imaginable health state’ (0). Change in EQ-5D-3L utility score and VAS score from baseline to month 6 between ITB and BMT arm were assessed. Change=EQ-5D-3L utility or VAS score at month 6 - EQ-5D-3L utility or VAS score.|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1427312|NCT01032239|Secondary|Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS)|GAS is designed to measure the achievement of treatment goals using the following 6 levels of achievement: worse than start (-3), much less than expected (-2), somewhat less than expected (-1), as expected (0), somewhat more than expected (+1), much more than expected (+2). The primary therapy goal and the criteria for the levels of achievement was defined by the medical team together with the patient and his/her family/legal representative/caregiver at the first day of the study. The number and percentage of patients who achieved the therapeutic goal at Month 6 was compared between the ITB and BMT arm.|month 6|Intent to treat analysis|||Participants|||Count of Participants
1427313|NCT01032239|Secondary|Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6|NPRS is designed to assess the level of pain a patient is feeling at a point in time. The following questions has been presented to patients: What is your actual spasticity-related or spasm-related pain? What was your least spasticity-related or spasm-related pain during the last week? What was your worst spasticity-related or spasm-related pain during the last week? The patient indicated how much pain he is feeling on a scale from 0 to 10. A score of 0 (zero) is “no pain” while a score of 10 (ten) is “worst possible pain”. Change in NPRS related to actual, least or worst pain from baseline to month 6 between ITB and BMT arm was assessed. Change=NPRS at month 6 - NPRS at baseline.|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1427314|NCT01032239|Secondary|Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance|Patient was asked to transfer from the wheelchair to bed without human assistance. High level functional patient (HLP) could transfer. Low level functional patient (LLP) was not able to transfer. Comparison of the number and percentage of HLP and LLP between ITB and BMT arms was evaluated.|baseline, month 3, month 6|Intent to treat analysis|||Participants|||Count of Participants
1427315|NCT01032239|Secondary|Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6|Change in average 10MTWT from baseline to month 6 beetween ITB and BMT arm. Change=10MTWT at month 6 - 10MTWT at baseline|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.Only High level functional patients (HLP) were analyzed. HLP were defined as patients able to transfer from the wheelchair to bed without human assistance.|||seconds||Standard Deviation|Mean
1429038|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery.|Lack of recall of picture demonstrates presence of amnesia on day following surgery|One day after surgery|per protocol|||percentage of patients|||Number
1427316|NCT01032239|Secondary|Change in Functional Independence Measure (FIM) Score From Baseline to Month 6|FIM contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence. Ratings should reflect actual observed performance, not capability. Total score ranges from 18 (lowest) to 126 (highest) level of independence. Change in FIM total score from baseline to month 6 between ITB and BMT arm was assessed. Change=FIM score at month 6 - FIM score at baseline.|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1427317|NCT01032239|Secondary|Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6|"AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the upper extremities were assessed: wrist flexors, elbow flexors, elbow extensors, shoulder abductors and shoulder adductors. Average AS was calculated as the average of AS scores of the 5 muscles of the affected lower extremities. Change in average AS in affected upper extremities from baseline to month 6 between ITB and BMT arm was assessed.~Change= AS at month 6 - AS at baseline."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1427318|NCT01032239|Primary|Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6|"AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed.~Change= AS at month 6 - AS at baseline."|Baseline and month 6|Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
1427319|NCT01032200|Secondary|HVLT-IR|HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. Minimum recalled words 0 maximum 36. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.|4 weeks post-RT|Participants with any data|||number of correctly recalled words||Standard Error|Least Squares Mean
1427320|NCT01032200|Secondary|Sleepiness|Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.|4 weeks post-RT|Participants with any data|||units on a scale||Standard Error|Least Squares Mean
1427321|NCT01032200|Secondary|Fatigue|Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.|4 weeks post-RT|Participants with any data|||units on a scale||Standard Error|Least Squares Mean
1427322|NCT01032200|Primary|Adherence|Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)|4 weeks post-RT (approximately 3 months post randomization)|Participants who returned pill diaries|||percentage of ideal number of pills||Full Range|Mean
1427323|NCT01032200|Primary|Retention|Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.|4 weeks post-RT (approximately 3 months post randomization)|All randomized participants|||percentage of participants|||Number
1427324|NCT01032174|Secondary|Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percentage of Participants|||Number
1427325|NCT01032174|Secondary|Percent Compliance With Prescribed Treatment Regimen|Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).|Day 11|The FAS population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation.|||Percent compliance||Standard Deviation|Mean
1427326|NCT01032174|Primary|Percentage of Participants With Response of Very Convenient or Somewhat Convenient|Participant reported outcome questionnaire was the assessment of participant’s convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered ‘very convenient’ or ‘somewhat convenient’ and 0 if participant answered ‘not convenient’ or ‘not at all convenient’.|Day 11|The Full Analysis Set (FAS) population included all participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy evaluation. 'N' signifies number of participants with non-missing data. Missing observations were not imputed.|||Percentage of Participants|||Number
1427327|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427328|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427797|NCT01027897|Primary|Elimination Constant (ke)|The elimination rate constant of a drug from the central compartment|after 3rd dose of study drug|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation|||per hour||Standard Deviation|Mean
1427329|NCT01032135|Primary|Percent Days Cocaine Use|Percent days of any cocaine use, self reported|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427330|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427331|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427332|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427333|NCT01032135|Primary|Any Cocaine Use|Any cocaine using self report, binary measure of percent days cocaine use.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427334|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427335|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~* heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 5 ( weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427336|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women"|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427337|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~* heavy drinking is defined as five or more drinks per day for men, four or more for women."|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427338|NCT01032135|Primary|Percent Days Heavy Drinking|"Percent days heavy drinking at follow up, from Time Line Follow Back~*heavy drinking is defined as five or more drinks per day for men, four or more for women"|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427339|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427340|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 5 (weeks 17 to 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427341|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427357|NCT01032070|Secondary|Apparent Volume of Distribution (Vz/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||mL/m^2||95% Confidence Interval|Geometric Mean
1427342|NCT01032135|Primary|Any Heavy Drinking Days|five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427343|NCT01032135|Primary|Any Heavy Drinking Days|days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427344|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 6 (weeks 21 - 24)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427345|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, fromTime Line Follow Back|Month 5 (weeks 17 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427346|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 4 (weeks 13 - 16 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427347|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427348|NCT01032135|Primary|Percent Days Drinking|Percent days of any drinking at follow up, from Time Line Follow Back|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||percentage of days||Standard Deviation|Mean
1427349|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 6 (weeks 21 - 24 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427350|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back, This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 5 (weeks 16 - 20 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427351|NCT01032135|Primary|Any Drinking|Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 4 (weeks 13 - 15 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427352|NCT01032135|Primary|Any Drinking Days in Previous Month|Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 3 (weeks 9 - 12 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427353|NCT01032135|Primary|Any Drinking Days in Previous Month|Days of any drinking in previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.|Month 2 (weeks 5 - 8 post baseline)|The number of participants analyzed represents the number that were available to provide research data. Those participants who were engaged and remained engaged in treatment were not included in these analyses.|||proportion of participants||Standard Deviation|Mean
1427354|NCT01032135|Primary|Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks|Number of treatment sessions attended|weeks 9 - 12||||treatment days||Standard Deviation|Mean
1427355|NCT01032135|Primary|Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks|Number of treatment sessions attended|weeks 9 - 12||||treatment days||Standard Deviation|Mean
1427356|NCT01032135|Primary|Treatment Engagement|Number of treatment sessions attended|weeks 3 - 12||||treatment days||Standard Deviation|Mean
1427358|NCT01032070|Secondary|Apparent Body Clearance (CL/F) of Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||mL/h/m^2||95% Confidence Interval|Geometric Mean
1427359|NCT01032070|Secondary|Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||hours||95% Confidence Interval|Geometric Mean
1427360|NCT01032070|Secondary|Maximum Observed Plasma Concentration of Erlotinib (Cmax)|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set|||ng/mL||95% Confidence Interval|Geometric Mean
1427361|NCT01032070|Secondary|Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib|Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.|Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.|The Pharmacokinetics Analysis Set (PKAS) consisted of the participants treated with erlotinib for whom sufficient analyte concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter. Participants may have been excluded from the PKAS for reasons such as missing data or protocol deviation.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1427362|NCT01032070|Secondary|Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs.~An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. The relationship of each AE to study drug was assessed as either related or not related."|From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|All enrolled participants who received at least 1 dose of study drug (Safety Analysis Set).|||participants|||Number
1427363|NCT01032070|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.|From randomization up to 12 months after the last dose. Median duration of follow-up was 12.9 months for erlotinib and 14.4 months for etoposide.|The Full Analysis Set|||days||95% Confidence Interval|Median
1427364|NCT01032070|Secondary|Duration of Stable Disease|"Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD.~Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR, PR, MR or SD.|||days||95% Confidence Interval|Median
1427365|NCT01032070|Secondary|Percentage of Participants With Prolonged Stable Disease|Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1427366|NCT01032070|Secondary|Progression Free Survival (PFS)|"Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first.~Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||days||95% Confidence Interval|Median
1427377|NCT01031979|Primary|Trauma-Cued Heart Rate Reactivity|The primary outcome was trauma-cued heart rate reactivity a week after the drug visit as measured by the PTSD Brief Reactivity (PBR) task. For each patient, a 3-minute trauma script was constructed containing vivid details of the target trauma and used in tandem with a standard neutral script for baseline measurement. Heart rate reactivity for each time point was the beats per minute (BPM) difference between the neutral and trauma scripts represented as a slope.|One week after drug visit||||beats per minute||Standard Error|Mean
1427367|NCT01032070|Secondary|Percentage of Participants With Disease Control|"Disease control is a best overall response of CR or PR or MR or Stable disease (SD).~CR:~Complete disappearance of all enhancing tumor and mass effect~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks~If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively).~PR:~≥ 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks.~MR:~≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks.~SD:~Neurologic examination is at least stable~Maintenance corticosteroid dose is not increased~MRI meets neither the criteria for minor response nor for progressive disease~Sustained for ≥ 8 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1427368|NCT01032070|Secondary|Percentage of Participants With a Minor Response|"Participants with a best overall response of minor response (MR), defined as:~≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
1427369|NCT01032070|Secondary|Duration of Response|"Duration of response (complete or partial response [CR/PR]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR.~Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|Full Analysis Set participants whose best overall response was CR or PR.|||days||95% Confidence Interval|Median
1427370|NCT01032070|Primary|Percentage of Participants With an Objective Response|"Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks.~CR:~Complete disappearance of all enhancing tumor and mass effect~On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses)~Stable or improving neurologic examination sustained for ≥ 4 weeks~If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings).~PR:~≥ 50% reduction in tumor size by bi-dimensional measurement~On a stable or decreasing dose of corticosteroids~Stable or improving neurologic examination sustained for ≥ 4 weeks."|From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.|The Full Analysis Set (FAS) consisted of all randomized participants. Following the intent-to-treat (ITT) principle, participants were analyzed according to the treatment arm they were assigned to at randomization.|||percentage of participants||95% Confidence Interval|Number
1427371|NCT01032044|Primary|"Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated"|"Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of Optimally Treated, in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up."|3 month follow-up endoscopic procedure|Among the 141 patients who completed the initial procedure, 119 had follow-up visits.|||participants|||Number
1427372|NCT01032018|Primary|Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services)||6 months after randomization||||dollars||Standard Error|Mean
1427373|NCT01032018|Primary|Depressive Symptom Reduction|Symptoms of depression were assessed using the Beck Depression Inventory (BDI). This 21-question, multiple choice self-report instrument includes items pertaining to symptoms of depression, including hopelessness and irritability, physical symptoms such as fatigue, and thoughts such as guilt. Each item has at a set of four possible responses, ranging in intensity for least intense to most intense. The total score is calculated by adding the responses to each item. Higher scores indicate more severe depressive symptoms. The total score on the scale ranges from 0 to 63. Total scores on the scale of less 10 indicate minimal depression; total scores between 10 and 15 indicate mild depression; and total scores greater than 16 indicate a probable clinical diagnosis of depression.|Change from depression at baseline to depression at 6-months||||Scores on a scale||Standard Deviation|Mean
1427374|NCT01031979|Secondary|Change in Becks Depression Inventory (BDI-II) Score|The BDI-II is a 21-item self-report measure that assesses depressive behavioral symptoms. It has demonstrated adequate psychometric validity, and external validity and is used widely as the dependent variable in treatment outcomes research. The BDI-II produces score ranges from 0-63, with higher scores indicating more severe depression symptom severity. A 5-point decrease on the BDI-II is considered clinically significant.|0 weeks, 15 weeks||||units on a scale||Standard Deviation|Mean
1427375|NCT01031979|Secondary|Change in Post Traumatic Stress Disorder Checklist (PCL) Score|The PCL is a 17-item self-report measure of PTSD symptom severity based on the DSM-IV and has adequate psychometric properties. The PCL produces a score range between 17-85, with higher scores indicating more distress related to PTSD symptoms. A 10-point decrease on the PCL is considered clinically significant.|0 weeks, 15 weeks||||units on a scale||Standard Deviation|Mean
1427376|NCT01031979|Secondary|Change in Clinician Administered PTSD Scale (CAPS) Score|The CAPS is a structured interview for diagnosis of PTSD and is widely considered the gold-standard assessment. The CAPS produces a total score ranging from 0-136, with higher scores indicating more severe PTSD symptom severity. A 15-point decrease is considered clinically significant.|0 Weeks, 15 weeks||||units on a scale||Standard Deviation|Mean
1427404|NCT01031550|Secondary|Peak Postoperative AST, ALT and T Bili||first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
1427378|NCT01031953|Secondary|Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness|Participants who self report pain/soreness at drug infusion site, headache, or dizziness at any of the study time points (2, 12, or 24 hours after receiving fosaprepitant) are measured in this outcome.|up to 24 hours after study drug administered.||||participants|||Number
1427379|NCT01031953|Secondary|Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant|Participants meeting this outcome self report experiencing drowsiness at any of the study time points (2, 12 or 24 hours after receiving fosaprepitant).|up to 24 hours after study drug administered.||||participants|||Number
1427380|NCT01031953|Secondary|Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)|The recommended dose Fosaprepitant (MK-0517) is 115 mg administered intravenously 30 minutes before chemotherapy treatment. In this study, a 150 mg dose will be given to study patients as rescue therapy after chemotherapy only in the event of breakthrough nausea or vomiting. Those participants who did not report episodes of emesis or did not require additional rescue medications are measured in this outcome|up to 24 hours after receiving fosaprepitant||||participants|||Number
1427381|NCT01031953|Secondary|Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)|Participants with persistent nausea/vomiting after 2 hours and who desired further treatment, received standard rescue therapy at the discretion of provider with prochlorperazine, metoclopramide or haloperidol with or without additional lorazepam until relief|2 hours after administration of Fosaprepitant 150 mg IV||||participants|||Number
1427382|NCT01031953|Secondary|Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours|Participants were asked to report any episodes of vomiting before (baseline) and up to 24 hours after receiving Fosaprepitant. The outcome considers the number of participants reporting any episodes of emesis after receiving Fosaprepitant.|Baseline to 24 hours after study drug administered.||||participants|||Number
1427383|NCT01031953|Secondary|Improvement in Nausea Score From 2 Hours to 24 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from 2 hours after receiving fosaprepitant to 24 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant reporting a lower value on the scale at the 12 or 24 hour time point would be considered in this outcome measure."|2 hours to 24 hours after study drug administered.||||participants|||Number
1427384|NCT01031953|Secondary|Improvement in Nausea Score From Baseline to 12 Hours|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 12 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 12 hours from baseline would be considered in this outcome measure."|Baseline to 12 hours after study drug administered.||||participants|||Number
1427385|NCT01031953|Primary|Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale|"The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from No Nausea to Nausea as bad as it can be; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure."|Baseline to 2 hours after study drug administered.||||participants|||Number
1427386|NCT01031914|Primary|Sleep/Wake Algorithm|We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true positives + number of true negatives/ number of true positives + false positives + false negatives +true negatives. where True positive = the algorithm tested correctly identified sleep, False positive = the algorithm tested incorrectly identified sleep, True negative = the algorithm tested correctly rejected awake periods, and False negative = the algorithm tested incorrectly rejected awake periods.|The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours.|All the participants completing the sleep study were included in the analysis|||accuracy (%)|||Number
1427387|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at week12|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.~Scale range (0-52):~A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 12||||Score on a scale||Standard Deviation|Mean
1427388|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 16||||units on a scale||Standard Deviation|Mean
1429039|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery|Lack of recall of picture shown at this time indicates presence of amnesia|Day of Surgery prior to discharge|per protocol|||percentage of patients|||Number
1427389|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 12||||units on a scale||Standard Deviation|Mean
1427390|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Week 04||||units on a scale||Standard Deviation|Mean
1427391|NCT01031810|Secondary|Quick Inventory of Depression- Self Report 16|"Quick Inventory of Depression- Self Report assesses 16 depressive symptoms experienced in the past week, based on self-rating, measured at study exit visit~Scale range (0-27):~Each of the four possible answers to each quiz is given an ascending numerical value from 0 to 3, and the total test score is the sum of the following: The highest number from questions 1-4 The number from question 5 The highest number from questions 6-9 The total of each question from 10-14 The highest number from questions 15-16~Total score interpretation: 0-5 no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe depression, 20 and above very severe depression"|Weeks 00||||units on a scale||Standard Deviation|Mean
1427392|NCT01031810|Primary|Hamilton Depression Rating Scale Scores 17 at Baseline|"HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.~Scale range (0-52):~A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial."|Week 00 (baseline)||||units on a scale||Standard Deviation|Mean
1427393|NCT01031706|Secondary|FEV1 (Spirometry) Change|Absolute change in % predicted FEV1 between baseline and after 4 weeks of treatment calculated|Baseline and after 4 weeks of treatment|All available data included. Carry-forward of last FEV1 value (after 2 weeks of treatment) performed when data at 4 week time point not available|||Percentage of predicted FEV1||Standard Error|Mean
1427394|NCT01031706|Primary|Change in Mucociliary Clearance Rate|"Average radio tracer clearance through 90 minutes (MCC90) is primary index of mucociliary clearance at each study.~Primary study outcome: is absolute change in MCC90 between baseline and at end of treatment (where MCC measured 8-12 hours after final dose of study drug) - reflects sustained impact on MCC"|Baseline versus after completion of 4 week treatment period|All subjects with available data analyzed|||percent clearance||Standard Error|Mean
1427395|NCT01031680|Secondary|Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m²|To compare the proportion of participants with BMI baseline ≥27 kg/m2 with a reduction from baseline of 5% or more in body weight with dapagliflozin 10 mg versus placebo from baseline to week 24. Least Squares Mean represents the percent of participants adjusted for baseline body weight and age stratum.|Baseline to Week 24|Full analysis set; participants with baseline BMI ≥27 kg/m² and Week 24 (LOCF) body weight value|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1427396|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF)|To compare the mean change in seated systolic blood pressure from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
1427397|NCT01031680|Secondary|Adjusted Mean Percent Change in Body Weight|To compare the mean percent change in body weight from baseline to week 24 between dapagliflozin 10 mg versus placebo.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of Body Weight||95% Confidence Interval|Least Squares Mean
1427398|NCT01031680|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP)|To compare the mean change in seated systolic blood pressure from baseline to week 8 between dapagliflozin 10 mg versus placebo.|Baseline to Week 8|Full Analysis Set, participants with non-missing baseline and Week 8 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
1427399|NCT01031680|Primary|Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit|To compare the clinical benefit of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension at week 24, measured as the proportion of responders for a 3-item endpoint of clinical benefit, defined as an absolute drop of 0.5% or more from baseline HbA1c, and a relative drop of 3% or more from baseline for total body weight, and an absolute drop of 3 mmHg or more from baseline in seated systolic blood pressure.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Number
1427400|NCT01031680|Primary|Adjusted Mean Change in HbA1c Levels|To compare the glycemic efficacy of dapagliflozin 10 mg versus placebo when added to usual care in type 2 diabetes patients with cardiovascular disease and hypertension, measured as the mean change in HbA1c from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
1427401|NCT01031628|Primary|Evaluation of Lesions for Progression or Response Via RECIST Criteria||Every 3 months|Data were not collected or analyzed due to early termination.||||||
1427402|NCT01031550|Secondary|Decrease in Liver Lipid Peroxidation and Apoptosis||first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
1427403|NCT01031550|Secondary|Length of ICU and Hospital Stay||first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
1427405|NCT01031550|Primary|Post Operative Complications Grade IIIb or Greater According to Clavien's Classification Which is a Classification System Used to Grade Surgical Complications|Post operative complications grade IIIB or greater according to Clavien's classification: IIIb=complication necessitating an intervention under general anesthesia; Grade IV=Life threatening complications requiring ICU management, IV a =single organ dysfunction, IVb=multi-organ dysfunction; V=death Suffix d(disability)=subject suffers from complication at time of discharge. This label indicates the need for a follow up to fully evaluate the complication.|first 7 post operative days|Due to termination of the study no data analysis was performed.||||||
1427406|NCT01031537|Primary|TBEV Viral Neutralization Titer >1:10|The number of participants that develop anti-tick borne encephalitis antibody viral neutralization titer levels (>1:10) following receipt of 3 doses of intramuscular FSME-IMMUN (vaccine series)|6 months|Six participants had protective antibody levels (>1:10) reflective of either prior successful immunization or infection at baseline and were not evaluated at the 6 month time point. One participant withdrew from the study prior to the 6 month evaluation time point.|||Participants|||Count of Participants
1427407|NCT01031537|Primary|TBEV Viral Neutralization Titer >1:10|Tick borne encephalitis antibody viral neutralization titer levels (>1:10)|Baseline|Baseline TBEV protective antibody levels (>1:10) reflective of either prior successful immunization or infection at baseline|||Participants|||Count of Participants
1427408|NCT01031498|Primary|Number of Patients With Complete Response|Number of emesis (vomiting) episodes and no use of rescue medication during the administration of chemotherapy assessed as complete response. Complete response is defined as < or equal to 1 episode of emesis during entire 7-day study period, no use of of rescue medication during the study period, and no more than moderate nausea (Grade 2, National Cancer Institutes (NCI) Common Terminology Criteria (CTC)) during chemotherapy.|7 days, starting first day of chemotherapy|Analysis was per protocol. Seven patients were excluded from the efficacy analysis.|||participants|||Number
1427409|NCT01031446|Secondary|Time to Progression in Patients With Metastatic Basal-like Breast Cancer.|Median duration in months from on-study to disease progression in patients with metastatic basal-like breast cancer. All patients with basal-like breast cancer are negative for estrogen, progesterone, and human epidermal growth factor (HER2) receptors.|Up to 64 weeks|Patients who are negative for estrogen, progesterone and HER2 receptors. Time to progression was not determined for 5 patients in this group: toxicity (2), withdrew after beginning treatment (1), no progression (1), and on-treatment (1).|||months||Full Range|Median
1427410|NCT01031446|Primary|Patients With Progression-free Survival|Patients who had not experienced disease progression and who were alive at 6 months after study entry|at 6 months|Patient who received the study drugs. Four patients were not available for measurement of progression at 6 months: toxicity (3), withdrew after beginning treatment (1)|||participants|||Number
1427411|NCT01031446|Secondary|Time to Progression|Duration in months from date on-study to date patient exhibited progressive disease|Up to 64 weeks|Patients who were available for determination of duration of time to progressive disease. Time to progression is unknown for 8 Phase II patients due to: on-treatment (1), toxicity (3), withdrew after beginning treatment (1), and no progression (3)|||months||Full Range|Median
1427412|NCT01031446|Secondary|Patients With Overall Response|Per Response Evaluation Criteria in Solid Tumor (RECIST) criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|every 12 weeks|Patients for whom an overall response could be measured. Four patients were not evaluable due to: withdrew after beginning treatment (1) and not evaluable due to only 1 cycle of treatment (3).|||participants|||Number
1427413|NCT01031446|Primary|Maximum Feasible Dose in mg of RAD001 (Everolimus)for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per day in Phase I that allows for safe and feasible administration the medication. The MTD is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy|at 8 weeks|Patients enrolled to determine the safety profile and recommended dose of cisplatin + RAD001 + paclitaxel in women with metastatic breast cancer|||mg|||Number
1427414|NCT01031446|Primary|Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer|The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 x 10 9/L for > 5 days), febrile neutropenia (ANC < 1.0 x 10 0/L with fever > 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia < 25 x 10 9/L or CTC Grade 3 < 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.|at 8 weeks|Patients enrolled to determine the safety profile and recommended doses of cisplatin + paclitaxel + everolimus (RAD001) in women with metastatic breast cancer|||mg/m2|||Number
1427415|NCT01031381|Secondary|Total Number of Participants Experienced a Response (Complete Response+Partial Response+Stable Disease)|The number participants who experienced Complete Response+Partial Response+Stable Disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Within 4 weeks (28 days) of study treatment initiation (baseline)|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days + imaging every 8-12 weeks|||participants|||Number
1427798|NCT01027897|Primary|Clearance (CL)|Clearance is the volume of drug removed from the body per unit of time (hrs).|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation|||liters per hour||Standard Deviation|Mean
1427416|NCT01031381|Primary|Progression-free Survival (PFS) at 6-months|The percentage of participants who were alive with the disease (cancer) at 6 months after treatment, but whose disease had not worsened/progressed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|Up to 36 months (data collection period for the cohort); Up to 6 months for participant|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously every 14 days|||percentage of participants||95% Confidence Interval|Number
1427417|NCT01031134|Secondary|Change in Hamilton Depression Rating Scale Scores|Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.|Baseline and 12 week|fewer number of participants in comparison to primary outcome measure reflect greater numbers of missing observations for the Hamilton outcome|||units on a scale||Standard Deviation|Mean
1427418|NCT01031134|Primary|Number of Participants Who Adhered to Physician Recommended Treatment|Any mental health service use over 12 weeks.|12 weeks||||Participants|||Count of Participants
1427419|NCT01031095|Primary|Major Adverse Cardiac Event||30 days||||percentage of event|||Number
1427420|NCT01031095|Primary|Major Adverse Cardiac Events||30 days||||percentage of event|||Number
1427421|NCT01031043|Primary|Distal Contractile Integral|The index of contractile strength of the esophageal smooth muscle. The range of the index being 0 mmHg *s*cm to >10,000 mmHg *s*cm where 0 represents no contractile strength. The index reflects the magnitude of distal esophageal contraction, taking into consideration the length, strength, and duration of the contraction.|Encounter 1 (day 1) and Encounter 2 (Month 14)|All subjects enrolled in the study|||mmHg*s*cm||Standard Deviation|Mean
1427422|NCT01031004|Primary|Average Wear Time||after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||hours per day||Standard Deviation|Mean
1427423|NCT01031004|Primary|Average Wear Time||after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||hours per day||Standard Deviation|Mean
1427424|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.|after 1 month|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427425|NCT01031004|Primary|Visual Acuity (VA)|Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.|after 1 week|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427426|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427427|NCT01031004|Primary|Subject Reported Symptoms|Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427428|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427429|NCT01031004|Primary|Slit Lamp Findings - Infiltrates|Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427430|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427431|NCT01031004|Primary|Slit Lamp Findings - Tarsal Abnormalities|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427432|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427433|NCT01031004|Primary|Slit Lamp Findings - Injection|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427434|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427435|NCT01031004|Primary|Slit Lamp Findings - Corneal Staining|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427436|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427437|NCT01031004|Primary|Slit Lamp Findings - Corneal Neovascularization|Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427438|NCT01031004|Primary|Corneal Edema at Month 1|Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|after 1 month of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427439|NCT01031004|Primary|Slit Lamp Findings - Corneal Edema|Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.|after 1 week of lens wear|This analysis includes all participants that completed the study per protocol.|||eyes|eyes||Number
1427440|NCT01030965|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28|Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.|Baseline, Day 1, and Day 28|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
1427441|NCT01030965|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline, Day 1, and Day 28|ITT Population. Participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the ITT Population with data avaialable at >=1 time point.|||Liters||Standard Error|Least Squares Mean
1427442|NCT01030965|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.|Baseline and Day 29|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of randomized study medication in the treatment period. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 29.|||Liters||Standard Error|Least Squares Mean
1427443|NCT01030952|Secondary|Change in Percent of 24 Hour Hyperglycemic Measurements|Measures/compares changes in percentage of hyperglycemia (>7.8mmol/l or 140 mg/dl) in glucose measurements in 24 hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.|||percent of measurements||Standard Deviation|Mean
1427444|NCT01030952|Secondary|The Percent of 24 Hour Hypoglycemic Measurements|Measures/compares changes in percentage of hypoglycemia(<3.9mmol/l or <70 mg/dl) in glucose measurements in 24hours by continuous glucose monitoring system (CGMS) at endpoint from baseline between groups. Reported values are percent change of the base absolute values [100% * ((X-Y)/Y)]|baseline, 3 weeks (end of study)|Intent-to-treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. During different time points, participants with observations at that time point were included in the analysis|||percent of measurements||Standard Deviation|Mean
1427445|NCT01030952|Secondary|Change in Mean Amplitude of Glycaemic Excursion (MAGE)|mean amplitude of glycaemic excursion (MAGE) is an average of the amplitudes of all glycemic excursions greater than a prespecified threshold size|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||mmol/l||Standard Deviation|Mean
1427446|NCT01030952|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 3. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
1427447|NCT01030952|Secondary|Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint|TG change in blood lipids level from baseline to endpoint|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
1427448|NCT01030952|Secondary|Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point|time to change in Total Cholesterol blood lipids level at 0, 30, 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
1427449|NCT01030952|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|change in LDL-C at 0, 30 and 120 minutes|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
1427450|NCT01030952|Secondary|Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline|This outcome measure calculated the change in insulin levels between groups over time at 0, 30 then 120 minutes|baseline, 3 weeks (end of study)|The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication.|||(μU/ml)||Standard Deviation|Mean
1427451|NCT01030952|Secondary|Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment|GSA levels were to be determined by CGMS at 7:00~10:00 am in the 4-hour standardized meal test before treatment after overnight fasting for efficacy assessments|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis.|||percent||Standard Deviation|Mean
1427452|NCT01030952|Secondary|Changes in 24 Hour Glucose Area Under Curve (AUCpp)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|baseline, end of study (3 weeks)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol*min/L||Standard Deviation|Mean
1427453|NCT01030952|Secondary|Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD)|The mean of the daily differences (MODD), calculated as the average absolute difference of paired glucose values during two successive 24 hour periods, was used to assess day-to-day glycaemic variability.|baseline, 3 weeks (end of study)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||millimoles per litre (mmol/l)||Standard Deviation|Mean
1427454|NCT01030952|Secondary|Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours.|Change in standard deviation (SD) from baseline of mean blood glucose (MBG) describes the range of blood glucose fluctuation over 24 hours.|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline|||mmol/l||Standard Deviation|Mean
1427455|NCT01030952|Secondary|Change in Mean Blood Glucose (MBG)|The 24 hour mean blood glucose (MBG) level was calculated as the mean of all the consecutive readings on baseline and end of study(3 weeks later) separately.|baseline and at 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline|||millimoles per litre (mmol/l)||Standard Deviation|Mean
1427456|NCT01030952|Secondary|Change in Incremental Glucose Peak (IGP) From Baseline|Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after meal|baseline, 3 weeks (end of study)|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.|||millimoles per litre (mmol/L)||Standard Deviation|Mean
1427457|NCT01030952|Primary|Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS)|"The postprandial glucose area under the curve (AUC)was calculated using values from the 3 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.~0-4 hours AUC were calculated using trapezoid methods."|3 weeks (end of study) minus baseline|Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline.|||millimoles hours per litre (mmol*hr/L)||95% Confidence Interval|Least Squares Mean
1427458|NCT01030822|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life- threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|After the first vaccination up to study end (from Month 0 to Month 15)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented.|||Subjects|||Number
1427459|NCT01030822|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31-day follow-up period (Days 0-30) after vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented.|||Subjects|||Number
1429737|NCT01012167|Secondary|Laboratory Measures - Calcium|Calcium blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1427460|NCT01030822|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal everyday activities. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented and with the symptom sheet filled in.|||Subjects|||Number
1427461|NCT01030822|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|Within the 4-day follow-up period (Days 0-3) after the booster dose for the Synflorix 1 and Synflorix 2 Groups and across doses for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine dose administration documented and with the symptom sheet filled in.|||Subjects|||Number
1427462|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1427463|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1427464|NCT01030822|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Persistence)|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1427465|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
1427466|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
1427467|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence)|OPA titers against cross-reactive pneumococcal serotypes 6A and 19A (Opsono-6A and -19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1429771|NCT01012037|Secondary|Percentage of Patients With Rescue Therapy|Percentage of patients with rescue therapy at Week 12. The analysis was performed on the full analysis set (FAS) using OC.|12 weeks||||percent|||Number
1427468|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1427469|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Antibodies assessed for this outcome measure were those against the cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for the Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1427470|NCT01030822|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Persistence)|Antibodies assessed for this outcome measure were those against cross-reactive pneumococcal serotypes 6A and 19A (ANTI-6A and -19A). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1427471|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
1427472|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for the Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||Titer||95% Confidence Interval|Geometric Mean
1427473|NCT01030822|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Persistence)|OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB + Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||Titer||95% Confidence Interval|Geometric Mean
1427474|NCT01030822|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Persistence)|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE) for the Synflorix 1 and Synflorix 2 Groups and prior to catch-up vaccination (PRE) for the Tritanrix-HepB+Hiberix Group|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results for antibodies against at least one pneumococcal serotype were available before the administration of the booster dose of the Synflorix™ vaccine.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1428695|NCT01019707|Primary|Diastolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion||||mm Hg|Timepoints post infusion|Standard Deviation|Mean
1427475|NCT01030822|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to vaccination (PRE), one month post-Dose 2 (Month 3), prior to (Month 6) and one month after the third (booster) vaccine dose (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1427476|NCT01030822|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|Prior to booster vaccination (PRE), one month after booster vaccination (Month 1) and at approximately 24 months of age: at Month 15 for Synflorix 1 Group and at Month 9 for Synflorix 2 Group (24 months of age)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at the requested time points. Primary results are results one month after booster vaccination (Month 1).|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1427477|NCT01030757|Secondary|Toxicity, Progression Free Survival, Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease), Median Duration of Clinical Benefit, and Median Overall Survival of Subjects.||1 year|Study was terminated due to low accrual; no results to report.||||||
1427478|NCT01030757|Primary|Tumor Response Rate (Complete Response + Partial Response).||1 year|Study was terminated due to low accrual; no results to report||||||
1427479|NCT01030718|Secondary|Collection of Blood Samples for Pharmacokinetic Analysis of Dasatinib Twice Daily (BID) That Will Contribute to Population Pharmacokinetic Modeling|Blood samples for pharmacokinetic analysis of Dasatinib BID that will contribute to population pharmacokinetic modeling were collected.|At any visit of later than Day 7, draw sample(s) at pretreatment trough (within 1 hour prior to dosing) or between 3 hours following treatment and prior to the next dose|There was no individual PK analysis done for this study; analyses were integrated and evaluated as a part of population PK of this drug.|||participants|||Number
1427480|NCT01030718|Secondary|Status of Point Mutations of BCR-ABL at Baseline (BL) and End of Study (EOS)|Point mutations of BCR-ABL detected or undetected in the Quantitative real-time PCR polymerase chain reaction (RQ-PCR) products|At baseline and discontinuation--the study period was extended until the launch of dasatinib in Japan, January 2009.|Treated participants|||participants|||Number
1427481|NCT01030718|Secondary|Participants With Detectable Mutations of RNA (mRNA) of BCR-ABL at Baseline and at Best Achievement|Detectable BCR-ABL transcripts (b3a2, b2a2 or minor) >=2.0 log copy/micrograms RNA, as measured by real-time quantitative PCR (RQ-PCR) at baseline and best achievement post-dose.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter, and at discontinuation|Treated participants|||participants|||Number
1427482|NCT01030718|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of OHR was computed only for participants whose best response was CHR or a MaHR or MiHR & was measured from the first day hematologic response criteria were met, provided they were confirmed 28 days later until the date of PD or death. Median duration of OHR in the CML-AP/BP arm was not yet reached.|||Days||Full Range|Median
1427483|NCT01030718|Secondary|Time to Overall Hematologic Response (OHR) in Accelerated or Blast Phase CML, and Ph+ALL|The overall hematologic response (OHR) rate is defined as the proportion of all treated subjects with a best response of major or minor hematologic response. Time to OHR = time from first dose of dasatinib until the first day measurement criteria are first met for hematologic response provided they were confirmed 28 days later. Subjects who neither progressed nor died were censored on the date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|OHR was computed only for subjects whose best response is CHR or MaHR or Minor HR (MiHR).|||Days||Full Range|Median
1427484|NCT01030718|Secondary|Duration of Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response (MaHR)=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Duration of MaHR was computed only for advanced diseases subjects whose best response is a MaHR and was measured from the first day MaHR criteria are met, provided they were confirmed 28 days later until the date of PD or death. Median Duration of MaHR was not yet reached in the CML-AP/BP arm.|||Days||Full Range|Median
1427494|NCT01030718|Secondary|Participants With CML-CP: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.|||Days||Full Range|Median
1427485|NCT01030718|Secondary|Time to Major Hematologic Response (MaHR) in Accelerated or Blast Phase CML, and Ph+ALL|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL; see Outcome Measures 14 and 15 for full definitions). Time to major hematologic response (MaHR)=time from first dose of dasatinib until the first day the measurement criteria for MaHR and is computed only for advanced diseases subjects whose best response is a major hematologic response. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving MaHR|||Days||Full Range|Median
1427486|NCT01030718|Secondary|Duration of Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|Duration of CHR was computed only for chronic phase CML subjects whose best response is CHR. It was measured from the first day complete hematologic response criteria are met provided they are confirmed 28 days later until the date treatment is discontinued due to PD or death. Subjects who neither progressed nor died were censored on the date of their last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR. Duration of CHR in the CML AP/BP arm has not yet been reached.|||Days||Full Range|Median
1427487|NCT01030718|Secondary|Time to Complete Hematologic Response (CHR) in Chronic Phase CML, Accelerated or Blast Phase CML, and Ph+ALL|CHR=all of the following criteria: WBC ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement. Time to CHR=time from first dose of dasatinib until the first day criteria for CHR are met provided they are confirmed 28 days later and was computed only for chronic phase CML subjects whose best response is CHR. Subjects who neither progressed nor died were censored at date of last hematologic assessment.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Participants achieving CHR|||Days||Full Range|Median
1427488|NCT01030718|Secondary|Participants With Ph+ ALL: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=(see Outcome Measure 14, above). NEL=WBC ≤ULN; BM blasts ≤5%; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; <20% peripheral blood basophils; no extramedullary involvement; and at least 1 of the following: ANC ≥500/mm3 and <2000/mm3 or platelets ≥20,000/mm3 and <100,000/mm3. Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated Ph+ ALL participants|||Percentage of Participants||95% Confidence Interval|Number
1427489|NCT01030718|Secondary|Participants With CML-AP/BP: Percentage of Participants With Hematologic Response|Major Hematologic Response=Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL). CHR=WBC <ULN; absolute neutrophil count (ANC) >1,000/mm3; platelets >100,000/mm3; no blasts or promyelocytes in peripheral blood; BM blasts ≤5%; <5% myelocytes + metamyelocytes in peripheral blood; <20% basophils in peripheral blood; no extramedullary involvement. NEL=(see Outcome Measure 15, below). Overall hematologic response (OHR)=best response of CHR, NEL or return to chronic phase (RTC).|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454); every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-AP/BP participants|||Percentage of Participants||95% Confidence Interval|Number
1427490|NCT01030718|Secondary|Participants With CML-CP: Percentage of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count (WBC) ≤institutional upper limit of normal(ULN); platelets <450,000/mm³; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils <20%; no extramedullary involvement.|baseline; every 4 weeks < 6 months on study (including study CA180031/NCT00337454), every 12 weeks >=6 months and <=2 years; every 24 weeks >2 years; at discontinuation|Treated CML-CP participants|||Percentage of Participants||95% Confidence Interval|Number
1427491|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-AP/BP arm.|||Days||Full Range|Median
1427492|NCT01030718|Secondary|Participants With CML-CP: Duration of Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Duration of MCyR was measured from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the first date of progressive disease (PD) or death. Subjects who neither relapsed nor died were censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Duration of MCyR was computed for subjects whose best response was either CCyR or PCyR. Median duration of MCyR was not yet reached in the CML-CP arm.|||Days||Full Range|Median
1427493|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Time to Major Cytogenetic Response (MCyR)|Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM). Time to MCyR was defined as the time from first dose of dasatinib until measurement criteria were first met for CCyR or PCyR (whichever status is recorded first).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Time to MCyR was computed only for participants whose best response was CCyR or PCyR.|||Days||Full Range|Median
1429699|NCT01012167|Secondary|Side Effect Checklist (SEC) - Sedation|"Percentage of participants with new onset or worsening compared to baseline of Sedation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1427495|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ALL: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of PD or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-AP/BP group.|||Days||Full Range|Median
1427496|NCT01030718|Secondary|Participants With CML-CP: Duration of Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Duration of CCyR was measured from the time measurement criteria are first met for CCyR until the first date of progressed disease (PD) or death. Subjects who neither relapsed nor died will be censored on the date of their last assessment.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Participants achieving CCyR. Median duration of CCyR was not yet reached in the CML-CP group.|||Days||Full Range|Median
1427497|NCT01030718|Secondary|Participants With CML-AP/BP and Ph+ ALL: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Participants achieving CCyR|||Days||Full Range|Median
1427498|NCT01030718|Secondary|Participants With CML-CP: Time to Complete Cytogenetic Response (CCyR)|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. Complete Cytogenetic Response (CCyR) = 0 Ph+ Cells in Metaphase in BM. Time to complete CCyR is defined as the time from first dose of dasatinib until measurement criteria are first met for CCyR, and is computed only for subjects whose best response is CCyR.|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454),|Participants achieving CCyR|||Days||Full Range|Median
1427499|NCT01030718|Secondary|Participants With Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated Ph+ ALL participants|||Percentage of Participants||95% Confidence Interval|Number
1427500|NCT01030718|Secondary|Participants With CML-Accelerated or Blast Phase (AP/BP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Ph+ Cells in Metaphase in BM).|At baseline, every 12 weeks up to 2 years on study (including study CA180031/NCT00337454), every 24 weeks thereafter|Treated CML-AP/BP participants|||Percentage of Participants||95% Confidence Interval|Number
1427501|NCT01030718|Secondary|Participants With Chronic Phase CML (CML-CP): Percentage of Participants With Cytogenetic Response|Cytogenetic responses (CyR) are based on the percentage of Ph+ metaphases among at least 20 metaphase cells in each bone marrow (BM) sample. The criteria for cytogenetic responses are as follows. Best CyR is defined as the best response obtained at any time during the study. Major Cytogenetic Response (MCyR) = Complete Cytogenetic Response (CCyR; 0 Ph+ Cells in Metaphase in BM), plus Partial Cytogenetic Response (PCyR; 1 - 35 Philadelphia positive [Ph+] Cells in Metaphase in BM).|At baseline, every 24 weeks thereafter (including study CA180031/NCT00337454)|Treated CML-CP participants|||Percentage of Participants||95% Confidence Interval|Number
1427502|NCT01030718|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|baseline; every 4 weeks (if on study < 6 months, including CA180-031(NCT00337454); every 12 weeks (if on study >=6 months and <=2 years); every 24 weeks (if on study >2 years); at discontinuation|All treated participants. Number of deaths represents all reported deaths, including after the study end. For AEs leading to discontinuation: 4 in CML-CP=1 insufficient effect (IE) +3 AEs in Participant Flow (PF); 7 in CML-AP/BP= 1 death + 5 AEs + 1 IE in PF; 4 in Ph+ALL=3 IE + 1AE in PF.|||participants|||Number
1427503|NCT01030666|Secondary|Radiographic Bony Fill 12 Months After Surgery (Reduction of Distance Cemento-enamel Junction [CEJ] to Bony Defect [BD])|If the CEJ was destroyed by the restorative treatment the margin of the restoration was taken as landmark. BD is defined as most coronal point where the periodontal ligament space shows a continuous width. If no periodontal ligament space could be identified, the point where the projection of the alveolar crest (AC) crossed the root surface was taken as a landmark. If both structures could be identified at one defect, the point defined by the periodontal ligament was used as BD and the crossing of the silhouette of the alveolar crest with the root surface was defined as AC. If several bony contours could be identified, the most apical one that crossed the root was defined as the BD and the most coronal one as AC.|Baseline to 12 months after surgery|ITT population. Missing data due to losing to follow-up: last observation carried forward. Patients whose radiographs could not be analysed were excluded.|||mm||Standard Deviation|Mean
1427504|NCT01030666|Primary|Vertical Clinical Attachment (PAL-V) Gain 6 Months After Surgery|Difference of PAL-V measurement at baseline and 6 months. PAL-V were measured to the nearest 0.5 mm using a straight manual periodontal probe (PCPUNC 15, Hu Friedy, Chicago, IL, USA). As reference for the PAL-V measurements, the cemento-enamel junction (CEJ) was used. If the CEJ is destroyed by a restoration (filling, crown) the margin of this restoration served as reference.|Baseline to 6 months after surgery|per protocol analysis: all participants who attended the 6 months re-examination|||mm||Standard Deviation|Mean
1427505|NCT01030653|Secondary|The Area Under the Curve Over the Dosing Interval for All Participants While on the High Dose and Low Dose Interventions.||12 hours||||hour*milligram/Liter||95% Confidence Interval|Geometric Mean
1427506|NCT01030653|Primary|Geometric Mean Ratio of the AUC Between the High and Low Dose Voriconazole|AUC is the area under the concentration-time curve. The Geometric Mean Ratio and 90% confidence interval around this value permit an assessment of the bioequivalence of two dosing regimens in the same group. The geometric mean is computed based on the ratio of the AUC value from the high dose compared to the AUC value from the low dose for each individual. This ratio provides a more robust interpretation of the differences between the two dosing arms because each individual serves as their own control.|14 days|This is a comparison of the same group analyzed through a cross-over design of two voriconazole dosing regimens|||Ratio||90% Confidence Interval|Number
1427507|NCT01030653|Primary|Steady-State Cmax and Cmin of Two Voriconazole Dosing Regimens|"Cmax is the maximum concentration, and Cmin is the minimum concentration. These measurements are based on analysis of plasma. The units shown are milligrams of voriconazole per liter of plasma. The two dosing regimens are:~a loading dose (400 mg x 2 doses, day 1) and maintenance doses (200 mg every 12 hours x 7 doses) in obese subjects.~a loading dose (400 mg x 2 doses, day 1) and maintenance doses (300 mg every 12 hours x 7 doses) in obese subjects."|Day 5|The same subjects were analyzed in a cross-over design at two dose levels|||mg/L||95% Confidence Interval|Mean
1427508|NCT01030536|Secondary|Percentage of Participants With Stable Disease (SD)||Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
1427509|NCT01030536|Secondary|Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs)|The correlation of CLS and weight changes, albumin, hypotension, edema, hypoxia, and pulmonary AEs were examined.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
1427510|NCT01030536|Secondary|Number of Participants With CD22 Expression Levels|CD22 Expression was analyzed using Prism® analysis. Flow cytometry was performed to quantitate the CD22 expression for the purpose of evaluating the relationship of CD22 expression with response to treatment.|Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)|Evaluable population for expression of CD22 on malignant cells included all participants with peripheral blood samples containing 10 or more B cells (CD19-positive cells) per cubic millimeter.|||Participants|||Count of Participants
1427511|NCT01030536|Secondary|Number of Participants With Positive Anti-Drug Antibody|The moxetumomab pasudotox specific bridging assay using the Meso Scale Discovery platform was employed to detect anti-drug antibodies (ADA).|Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
1427512|NCT01030536|Secondary|Elimination Half Life (t1/2) of Moxetumomab Pasudotox|Plasma decay half life is the time measured for the plasma concentration to decrease by one half.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||hour||Standard Deviation|Mean
1427513|NCT01030536|Secondary|Clearance (CL) of Moxetumomab Pasudotox|CL of drug is rate at which drug is metabolized or eliminated by normal biological processes and is influenced by fraction of dose absorbed.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||milliliter per hour per kilogram||Standard Deviation|Mean
1427514|NCT01030536|Secondary|Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox|Area under the concentration versus time curve from zero to infinity (AUC) of Moxetumomab pasudotox in Plasma.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
1427515|NCT01030536|Secondary|Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox|Maximum observed drug concentration of Moxetumomab pasudotox in plasma.|Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1427547|NCT01029886|Secondary|Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|Change in HDL-C from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmol/L||Standard Error|Least Squares Mean
1427516|NCT01030536|Secondary|Duration of Stable Disease (SD)|Duration of SD was defined as the time period from start of moxetumomab pasudotox administration to the event of progressive disease (PD)/relapse. Duration of SD was only calculated for the subgroup of participants with best response of CR, PR, or SD, and was calculated using the Kaplan-Meier method.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
1427517|NCT01030536|Secondary|Duration of Objective Response (DOR)|DOR was measured from the first documentation of OR to the event of relapse. DOR was calculated using the Kaplan-Meier method.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
1427518|NCT01030536|Secondary|Time to Response (TTR)|TTR was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was only assessed in participants who had achieved objective response (OR).|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
1427519|NCT01030536|Secondary|Percentage of Participants With Objective Response (OR)|OR was defined as the percentage of participants with CR or partial response (PR).|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
1427520|NCT01030536|Secondary|Percentage of Participants With Partial Response (PR)||Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
1427521|NCT01030536|Secondary|Duration of Complete Response|Duration of CR was measured from the first documentation of a CR to the time of relapse for the subgroup of participants with CR. Duration of CR was calculated using the Kaplan Meier method. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.|||Months||Full Range|Median
1427522|NCT01030536|Secondary|Percentage of Participants With Complete Response (CR)|The CR rate was defined as the percentage of participants who had achieved CR based on both the evaluable population for efficacy.|Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)|Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.|||Percentage of Participants|||Number
1427523|NCT01030536|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
1427524|NCT01030536|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
1427525|NCT01030536|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
1427548|NCT01029886|Secondary|Change in Total Cholesterol From Baseline to Week 26|Change in total cholesterol from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmol/L||Standard Error|Least Squares Mean
1442878|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Nausea|Nausea at any time during the post operative period for 48 hours|Immediate post operative to 48 hours||||Participants|||Number
1427526|NCT01030536|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From Screening (Day -28) to Post Therapy Day 30|Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.|||Participants|||Count of Participants
1427527|NCT01030536|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Any Grade 3 or greater, non-hematological toxicity (including capillary leak syndrome [CLS] and thrombotic microangiopathy/ hemolytic uremic syndrome (HUS), Grade 3 or higher treatment-related hematologic toxicities and only ≥ Grade 3 thrombotic microangiopathy /HUS constituted a DLT with few exceptions.|Day 1 to end of Cycle 1 (approximately 28 days)|Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.|||Participants|||Count of Participants
1427528|NCT01030536|Primary|Maximum Tolerated Dose (MTD)|MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity [DLT]) in more than 30 percent (%) of participants.|Day 1 to end of Cycle 1 (approximately 28 days)|Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.|||mcg/Kg|||Number
1427529|NCT01030458|Secondary|Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up|This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)|6 months follow-up after randomization||||participants|||Number
1427530|NCT01030458|Secondary|Side-effects to Study Medications||6 months follow-up after randomization||||participants|||Number
1427531|NCT01030458|Secondary|Time to Blood Pressure Control|The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.|6 months follow-up after randomization||||weeks||Inter-Quartile Range|Median
1427532|NCT01030458|Primary|Sitting Systolic Blood Pressure on Automated Measurement|Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.|6 months follow-up after randomization|The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.|||mmHg||Standard Deviation|Mean
1427533|NCT01030289|Secondary|Confidence Ratings in Guessing of Treatment Condition|"At the end of the participants' second appointment, they were asked to guess which tDCS session was real and which was sham. 0=completely guessing. 10=absolutely sure. We calculated how many participants correctly guessed when they received real and when they received sham. A composite index was created to control for correct-guessing in the mixed model analysis. A new variable was created wherein the guess correct value (0=incorrect guess, 1=correct guess) was multiplied by the guess confidence rating for each participant. Thus, those that guess incorrectly had a guess-composite value of 0 whereas those that guessed correctly had a value equal to their guess confidence."|After treatment||||units on a scale||Standard Deviation|Mean
1427534|NCT01030289|Secondary|Food Ingested and tDCS Condition|"Food was presented on a plate for the participants to eat after treatment. Each participant received a Chocolate Plate, Donut Plate, Cookie Plate, and a Potatoe Chip Plate. Each participant received the same amount of food on each plate. Each plate was weighed in grams separately before and after eating the food. A difference score was calculated to determine how much food was eaten for each type of food.~The mean difference score was calculated for each type of food for the Sham tDCS group & the Real tDCS group. The means and standard deviations of percent change in the decrease of food (weighed in grams) ingested post-tDCS treatment are reported below for the real tDCS group and the sham tDCS group."|After treatment||||percent change in grams of food ingested||Standard Deviation|Mean
1427535|NCT01030289|Secondary|Inability to Resist Food and tDCS Condition|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before, during, and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings, completely resist food) to 100 (extreme food cravings, unable to resist food).~The before treatment, during treatment, and after treatment resist ratings for carbohydrates were used to calculate percent change."|before treatment, during treatment, after treatment||||percentage of change in resist ratings||Standard Deviation|Mean
1427536|NCT01030289|Secondary|Cravings for Carbohydrate Foods|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment, during, and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings) to 100 (extreme food cravings).~The before treatment, during treatment, and after treatment ratings for carbohydrates were used to calculate percent change."|before treatment, during treatment, after treatment||||percentage of change in cravings||Standard Deviation|Mean
1429722|NCT01012167|Secondary|Laboratory Measures - Protein|Protein blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
1427537|NCT01030289|Secondary|Cravings for Sweet Foods|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment and after real tDCS and Sham tDCS. The scale ranged from 0 (no sweet food cravings) to 100 (extreme sweet food cravings).~The before treatment after treatment ratings for sweet food craving were used to calculate percent change."|before treatment, after treatment||||percentage of change in cravings||Standard Deviation|Mean
1427538|NCT01030289|Primary|Food Cravings|"Twenty-four images of food were presented in random order using a custom developed computer program. While viewing the food images, participants used a computerized visual analog scale to rate how much they would like to eat each food right now if it were actually available to them, how much they liked the food, and how much would they be able to resist tasting the food if it were in front of them. They viewed the pictures and rated before treatment and after real tDCS and Sham tDCS. The scale ranged from 0 (no food cravings) to 100 (extreme food cravings).~The before treatment after treatment food craving ratings were used to calculate percent change."|before treatment, after treatment||||percentage of change in cravings||Standard Deviation|Mean
1427539|NCT01029925|Primary|Response Rate by RECIST Criteria of Oral Dichloroacetate in Patients With Recurrent and/or Metastatic and Pretreated Breast and Non-small Cell Lung Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|upto 72 days|Intent to treat analysis was performed. Zero patients achieved complete or partial response in this study.|||participants|||Number
1427540|NCT01029912|Primary|Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP).|"The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.~Lower times are considered to be a better outcome.~For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged."|2 timepoints: Prior to treatment, and End of treatment at 6 weeks.||||seconds||Standard Error|Mean
1427541|NCT01029912|Primary|Change in Gait Velocity (cm/Sec) at End of Treatment|Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged.|2 timepoints: Prior to treatment, and End of treatment at 6 weeks.||||cm/sec||Standard Error|Mean
1427542|NCT01029912|Primary|Change in Lower Extremity Fugl-Meyer Score at End of Treatment|"The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0.~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and End of treatment at 6 weeks.||||units on a scale||Standard Error|Mean
1427543|NCT01029886|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.|||events per subject-year||Standard Error|Mean
1427544|NCT01029886|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26|Change in DBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmHg||Standard Error|Least Squares Mean
1427545|NCT01029886|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 26|Change in SBP from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmHg||Standard Error|Least Squares Mean
1427546|NCT01029886|Secondary|Ratio of Fasting Triglycerides at Week 26 to Baseline|Ratio of fasting triglycerides (measured in mmol/L) treatment endpoint at Week 26 to baseline. Log(Postbaseline fasting triglycerides) - log(Baseline fasting triglycerides); change from baseline to the treatment endpoint at Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||ratio||Standard Error|Least Squares Mean
1427870|NCT01027364|Secondary|Number of Injections Required to Maintain Hemostasis During Major Surgery|The number of injections to maintain hemostasis during surgery includes all injections for surgery purposes including the loading dose to the end date/time of surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||injections|Major Surgeries|Full Range|Median
1427549|NCT01029886|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||kg||Standard Error|Least Squares Mean
1427550|NCT01029886|Secondary|Change in Fasting Serum Glucose From Baseline to Week 26|Change in fasting serum glucose from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||mmol/L||Standard Error|Least Squares Mean
1427551|NCT01029886|Secondary|Percentage of Patients Achieving HbA1c <7.0% at Week 26|Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.|Baseline, Week 26|ITT Population. Missing data at endpoint was imputed using last observation carried forward approach.|||percentage of patients|||Number
1427552|NCT01029886|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to the treatment endpoint at Week 26.|Baseline, Week 26|ITT Population: all patients who were randomized and received study drug. All observed data from all scheduled visits (including early termination visits) were included in the mixed-model repeated measures (MMRM) analysis. Data collected at the early termination visits were mapped into the following scheduled visits.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1427553|NCT01029795|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks.|No participants had data analyzed due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
1427554|NCT01029795|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
1427555|NCT01029795|Secondary|Mean Afternoon Dose of LY2599506 During the 12-week Treatment Period|Assigned afternoon dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
1427556|NCT01029795|Secondary|Mean Morning Dose of LY2599506 During the 12-week Treatment Period|Assigned morning dose, in milligrams (mg), for each participant at each visit. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 1, 2, 3, 4, 6, 8, 10, 12 weeks.|Data were reviewed but are not presented due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
1427557|NCT01029795|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to the insufficient sample size.|||beats per minute (bpm)||Standard Deviation|Mean
1427558|NCT01029795|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAJ was terminated after enrolling 38 participants. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes per 30 days|||Number
1427559|NCT01029795|Secondary|Area Under the Concentration-Time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (Pop PK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.|||nanograms per milliliter times hour||Standard Deviation|Mean
1427569|NCT01029795|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1427560|NCT01029795|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from Population PK (PopPK) modeling. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.|||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
1427561|NCT01029795|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.|||percentage of participants|||Number
1427562|NCT01029795|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
1427563|NCT01029795|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1427564|NCT01029795|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||kilograms (kg)||Standard Deviation|Mean
1427565|NCT01029795|Secondary|Number of Hypoglycemic Episodes During 12-week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant felt s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAJ was terminated after enrolling only 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes|||Number
1427566|NCT01029795|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBP minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||mm Hg||Standard Deviation|Mean
1427567|NCT01029795|Secondary|Change From Baseline in the Perceptions About Medications – Diabetes (PAM-D) Questionnaire at 12 Weeks and 16 Weeks|"PAM-D assesses participants' perceptions about their diabetes medications during the past month. Responses ranged from None of the time, to All of the time. The sum of all items in the scale equals the scale score, which was linearly transformed to a 0 (least favorable state) to 100 (most favorable state). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed."|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1427568|NCT01029795|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1429723|NCT01012167|Secondary|Laboratory Measures - Bilirubin|Bilirubin blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1427570|NCT01029795|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1427571|NCT01029795|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1427572|NCT01029795|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1427573|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.|||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
1427574|NCT01029795|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.|||percentage of beta cell function (%B)||Standard Deviation|Mean
1427575|NCT01029795|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.|||milliseconds (ms)||Standard Deviation|Mean
1427576|NCT01029795|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAJ was terminated after enrolling 38 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1427577|NCT01029782|Primary|The Number of Patients Failing Therapy After 72 Hours of Antibiotic Treatment With Oral Cephalexin or Intravenous Cefazolin Plus Oral Probenecid.||72 hours|Per-Protocol Analysis at 72 hours.|||Participants|||Count of Participants
1427578|NCT01029730|Secondary|Number of Participants With Adverse Events as a Measure of Safety.|Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in >1 patient|Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.|All patients|||participants|||Number
1427579|NCT01029730|Secondary|Median Progression-free Survival|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.||||months||95% Confidence Interval|Median
1427580|NCT01029730|Secondary|Overall Response Rate|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|At 3 and 6 months during treatment, then 6 months post-treatment.|All patients evaluable for response.|||percentage of evaluable participants|||Number
1427581|NCT01029730|Primary|Complete Response Rate|Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.|18 months|All evaluable patients|||percentage of evaluable participants|||Number
1427582|NCT01029704|Secondary|Changes From the Baseline in the Urinary Glucose Excretion at End of 28 Days|Urinary glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the urinary glucose level during the study period was calculated by reducing the baseline urinary glucose level (day 1) from urinary glucose level at end of treatment (day 28) (i.e urinary glucose level on day 28 minus urinary glucose level on Day 1).|baseline (day 1) and 28 days||||g/24h||Standard Deviation|Mean
1427583|NCT01029704|Secondary|Changes From the Baseline in the Hemoglobin A1c (HbA1c) at End of 28 Days|HbA1c levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the HbA1c level during the study period was calculated by reducing the baseline HbA1c level (day 1) from HbA1c level at end of treatment (day 28) (i.e HbA1c level on day 28 minus HbA1c level on Day 1).|baseline (day 1) and 28 days||||Percent||Standard Deviation|Mean
1427584|NCT01029704|Secondary|Change From the Baseline in the Body Weight at End of 28 Days|Body weight was measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the body weight during the study period was calculated by reducing the baseline body weight (day 1) from body weight at end of treatment (day 28) (i.e body weight on day 28 minus body weight on Day 1).|baseline (day 1) and 28 days||||Kg||Standard Deviation|Mean
1427585|NCT01029704|Primary|Changes From the Baseline in the Fasting Plasma Glucose at End of 28 Days|Fasting glucose levels were measured at two time points; on day 1 (baseline) and day 28 (end of treatment). Changes in the fasting plasma glucose level during the study period was calculated by reducing the baseline glucose level (day 1) from glucose level at end of treatment (day 28) (i.e glucose level on day 28 minus glucose level on Day 1).|baseline (day 1) and 28 days||||mg/dL||Standard Deviation|Mean
1427586|NCT01029691|Secondary|NICU Admission|Number of mothers who had one (or more) babies admitted to NICU|at delivery (within 6 months of enrollment)||||Participants|||Count of Participants
1427587|NCT01029691|Secondary|Birth Weight||At delivery (within 6 months of enrollment)|There is one extra baby in each arm to represent the twins born in each group.|||grams|babies|Standard Deviation|Mean
1427588|NCT01029691|Secondary|Gestational Age at Delivery||At delivery (within 6 months of enrollment).||||weeks||Standard Deviation|Mean
1427589|NCT01029691|Primary|Number of Participants With Sleep-disordered Breathing (SDB)|Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)|Baseline night 1|This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).|||Participants|||Count of Participants
1427590|NCT01029691|Primary|Severity of Sleep Disordered Breathing|Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.|at baseline|This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).|||apnea/hypopnea index||Standard Deviation|Mean
1427591|NCT01029691|Primary|Number of Participants With Worsening of Hypertension|This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.|1-6 months after enrollment.|One woman in the standard of care group died during pregnancy and is therefore not included in this analysis.|||participants|||Number
1427592|NCT01029691|Primary|Nocturnal Blood Pressure|measured by a 24 hour cuff, averaged across the night;|baseline and 1 week after PAP treatment.|The standard of care group did not have nocturnal blood pressure monitoring as they were not assigned to use a positive airway pressure device|||mmHg||Standard Deviation|Mean
1427593|NCT01029652|Secondary|Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
1427594|NCT01029652|Secondary|Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
1427631|NCT01029535|Secondary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator’s Wrinkle Assessment Scale (WAS)|The physician assessed the left side and the right side of the participant’s face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
1431574|NCT00997516|Secondary|Operative Time|The amount of time to perform the operation from skin-incision to application of the dressing. This time is routinely charted by the circulating nurse in the operating room.|up to 6 hours||||minutes||Standard Deviation|Mean
1427595|NCT01029652|Secondary|Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
1427596|NCT01029652|Secondary|Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
1427597|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
1427598|NCT01029652|Secondary|Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab|The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.|||Percentage of participants|||Number
1427599|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|72 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.|||Participants|||Number
1427600|NCT01029652|Secondary|Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab|Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included|||mg/L||Standard Deviation|Mean
1427609|NCT01029652|Secondary|Physician’s Global Assessment of Response to Treatment|The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s assessments (pain intensity [Visual Analog Scale and Likert scale] and patient’s global assessment of response to treatment).|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
1427601|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab|High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.|24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)|Modified Analysis Set (MAS) consists of all FAS patients who were either re-treated or switched to canakinumab during 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included|||mg/L||Standard Deviation|Mean
1427602|NCT01029652|Secondary|Flare Rate Per Year|"Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||New flares per patient per year||Standard Deviation|Mean
1427603|NCT01029652|Secondary|Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|72 weeks overall|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||days||95% Confidence Interval|Median
1427604|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)|Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|7 days post dose (randomization), 24 weeks post-dose|Full Analysis Set includes all patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
1427605|NCT01029652|Secondary|Physician’s Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of patients in each category is reported.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)|Full Analysis Set (FAS): All patients that received study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
1427606|NCT01029652|Secondary|Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint|The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of patients in each category is reported.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
1427607|NCT01029652|Primary|Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)|This was the primary endpoint of both extension studies. Adverse event is defined as any unfavorable and unintended diagnosis, symptom, sign(including an abnormal laboratory finding),syndrome or disease which either occurs during the study, having been absent at baseline, or,if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|24 weeks overall|Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.|||Participants|||Number
1427608|NCT01029652|Secondary|Patient’s Global Assessment of Response to Treatment|Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations analyzed for this endpoint at specified time points.|||Percentage of participants|||Number
1427630|NCT01029535|Secondary|Change From Baseline in the MFVDS Score|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1427610|NCT01029652|Secondary|High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall|High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.|72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. Patients with baseline flare and data at 72 hours post-dose in core and patients with a new flare and data at 72 hours post-dose for the last post-baseline flare (during 24 weeks overall) were included in this analysis.|||mg/L||95% Confidence Interval|Least Squares Mean
1427611|NCT01029652|Secondary|Percentage of Participants Who Took Rescue Medication|Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.|during 12 weeks core, 24 weeks overall|"The Full Analysis Set (FAS) consisted of all patients as randomized in core study who had taken at least one dose of study drug. 12 weeks:Core consisted of patients taking rescue medication during baseline flare of Core study and 24 weeks:Overall consisted of patients who took rescue medication during last post-baseline flare during 24 weeks."|||Percentage of participants|||Number
1427612|NCT01029652|Secondary|Amount of Rescue Medication Taken|"Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:~Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.~If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolon as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare."|7 days last post-baseline flare (during 24 weeks)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations at 7 days last post-baseline flare were included in this analysis.|||mg||Standard Deviation|Mean
1427613|NCT01029652|Primary|Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||mm||Standard Error|Least Squares Mean
1427614|NCT01029652|Secondary|Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)|Maximum severity is the maximum Likert score recorded after the start of the flare. Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).|Last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with baseline and last post-baseline observations were included in this analysis.|||Percentage of participants|||Number
1427615|NCT01029652|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension|Patients scored their pain intensity in the joint most affected at baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was applied to impute post dose measurements.|||mm||Standard Error|Least Squares Mean
1427616|NCT01029652|Secondary|Time to First Intake of Rescue Medication After the Last Post Baseline Flare.|The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.|72 hours post-dose for the last post-baseline flare (during 24 weeks overall)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Patients with observations 72 hours post-dose for the last post-baseline flare during 24 weeks were included in analysis.|||Hours||95% Confidence Interval|Median
1427617|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||New flares/patient/24 weeks||Standard Deviation|Mean
1427618|NCT01029652|Secondary|Time to First New Flare|"Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|24 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Days||95% Confidence Interval|Median
1427619|NCT01029652|Secondary|SF36 Physical Function Score at Week 12|The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.|Week 12|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participant observations at Week 12 were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1427620|NCT01029652|Secondary|Mean Number of New Gout Flares Per Patient|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||New flares/patient/12 weeks||Standard Deviation|Mean
1427621|NCT01029652|Secondary|Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks|"Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before the flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Percentage of participants|||Number
1427622|NCT01029652|Secondary|Percentage of Participants With Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1427623|NCT01029652|Secondary|Time to Complete Resolution of Pain|Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.|7 days post-dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Hours||95% Confidence Interval|Median
1427624|NCT01029652|Secondary|Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)|The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.|From baseline to 7 days post dose (randomization)|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.|||Hours||95% Confidence Interval|Median
1427625|NCT01029652|Primary|Time to First New Flare|"Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event – date of first dose of study drug + 1).~Patients met definition of new flare if they had:~Flare in joint, not a previously affected joint (at baseline or during study)~Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.~Patients did not meet criterion of having new gout flare if:~· Increasing/renewed gout pain in an affected joint before flare has resolved completely."|12 weeks|The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.|||Days||95% Confidence Interval|Median
1427626|NCT01029535|Secondary|Percentage of Participants Satisfied or Very Satisfied With the Treatment|Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.|Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
1427627|NCT01029535|Secondary|Change From Baseline in the Subject’s Self-Perception of Age (SPA)|The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||years||Standard Deviation|Mean
1427628|NCT01029535|Secondary|Subject’s Assessment of Global Aesthetic Improvement Score (GAIS)|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1427629|NCT01029535|Secondary|Physician Assessment of Global Aesthetic Improvement Score (GAIS)|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.|Baseline, Weeks 4, 8, 52, 78 and 104|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||score on a scale||Standard Deviation|Mean
1443752|NCT00906204|Secondary|Patient Survival|Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation.|12 months post-transplantation||||participants|||Number
1427632|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 104|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427633|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 78|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427634|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 52|The physician rated the participant’s midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427635|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 104|The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427636|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 78|The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427637|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 52|The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427638|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 104|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427639|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 78|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427640|NCT01029535|Primary|Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52|The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.|Baseline, Week 8, Week 52|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of participants|||Number
1427641|NCT01029535|Primary|Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 8|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
1427642|NCT01029535|Primary|Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 4|The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.|Baseline, Week 4|ITT population included all enrolled participants who received at least one application of VOLUMA™.|||percentage of particpants|||Number
1427643|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 8|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of particpants|||Number
1427644|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 4|The physician rated the participant’s midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
1427663|NCT01029340|Secondary|Part A - Number of Participants With Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 6 weeks after first injection of study drug|Safety population|||Participants|||Number
1427645|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 8|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 8|Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
1427646|NCT01029535|Primary|Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 4|The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.|Baseline, Week 4|Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.|||percentage of participants|||Number
1427647|NCT01029405|Secondary|Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.|Day 42|Intent-to-treat population included all randomized participants who received the study medication.|||percenatge of participants|||Number
1427648|NCT01029405|Primary|Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.|Day 42|Intent-to-treat population included all randomized participants who received study medication.|||percenatge of participants|||Number
1427649|NCT01029392|Secondary|Change in Insulin Requirements|Percentage change from baseline number of units of lantus insulin over 6 months.|6 months|20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.|||percentage change of baseline insulin||Standard Deviation|Mean
1427650|NCT01029392|Primary|Change in Hemoglobin A1c|Change in hemoglobin A1c calculated as a percentage change from baseline measurement|6 months|20 patients in the Vitamin D Supplement arm and 11 patients in the No-Vitamin D supplement arm were withdrawn and not analyzed.|||percentage change from baseline||Standard Deviation|Mean
1427651|NCT01029366|Secondary|Overall Response Summary|"Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2013 v.1).~Efficacy assessments for CLL were based on lymphadenopathy, hepatomegaly, splenomegaly, bone marrow and blood morphologic and laboratory assessments. The response criteria are consistent with NCCN Guidelines Version 2.2012 CLL/SLL, which is based on the 2008 International Workshop Group on CLL (IWCLL) revisions of the original guidelines for evaluating disease response released in 1996 by the National Cancer Institute Working Group (NCI/WG)."|5 years||||percentage of participants|||Number
1427652|NCT01029366|Primary|Number of Participants With Adverse Events||5 years||||participants|||Number
1427653|NCT01029340|Secondary|Part C - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|at the time of surgery|ITT|||Participants|||Number
1427654|NCT01029340|Secondary|Part B - Number of Participants With Assessment of the Hemostasis During Major Surgery|An assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operations|An average of 1 month after start of treatment|ITT|||Participants|||Number
1427655|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|before and 3 weeks after surgery|ITT|||Participants|||Number
1427656|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 12 months after drug administration|ITT|||Participants|||Number
1427657|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Host Cell Proteins (HCP)|A test to ensure that participants have not developed antibodies to HCP during the study|Up to 4 weeks after drug administration|ITT|||Participants|||Number
1427658|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|before and 3 weeks after surgery|ITT|||Participants|||Number
1427659|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 12 months after drug administration|ITT|||Participants|||Number
1427660|NCT01029340|Secondary|Part A - Number of Participants With Incidence of Antibody Formation to Heat-shock Protein (HSP-70)|A test to analyze the formation of antibodies to HSP-70|Up to 6 weeks after drug administration|Safety population|||Participants|||Number
1427661|NCT01029340|Secondary|Part C - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|before and 3 weeks after surgery|ITT|||Participants|||Number
1427662|NCT01029340|Secondary|Part B - Number of Participants With Incidence of Inhibitory Antibody Formation|A test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973|Up to 12 months after drug administration|Safety population|||Participants|||Number
1427664|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Utility Index as Measured by EQ–5D Questionaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. 1.0 = Best possible score, -0.594 = Worst possible score. Positive changes from baseline indicate an improvement and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 61 of the 62 participants had data available for the Utility Index of the EQ-5D questionnaire at Month 12.|||Scores on a scale||Full Range|Median
1427665|NCT01029340|Secondary|Part B - Changes From Baseline at 12 Months in Quality of Life (QoL) as Measured by Transformed Total Score of Haemo-QoL Questionnaire|A measure of how treatment with BAY81-8973 affected the daily life of participants. the scoring system has 100 points. 0 is the worst possible score. 100 is the best possible score. Positive changes from baseline indicate an improvement in quality of life and negative changes indicate a deterioration.|Baseline and 12 months|ITT. Note: Only 51 of the 62 participants had data available for the 12-month QoL analysis.|||Scores on a scale||Full Range|Median
1427666|NCT01029340|Secondary|Part B - Control of Bleeding as Measured by the Number of Injections Required to Treat a Bleed|The number of injections needed by participants to stop a bleed|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.|||Injections|Participants|Full Range|Median
1427667|NCT01029340|Secondary|Part B - Annualized Number of Bleeds in Each 6-month Potency Assignment Period|The annualized number of bleeds experienced by participants in each of the two treatment periods|6 months on each potency|ITT. Note: One participant in Part B did not receive any Recombinant Factor VIII measured by the CS/ADJ method, leading to 61 participants (not 62) in that group.|||Bleeds||Inter-Quartile Range|Median
1427668|NCT01029340|Secondary|Part B - The in Vivo Recovery Values of Human Factor VIII (FVIII)|The amount of Factor VIII found in blood samples taken after the injection of the study drug at the beginning of the CS/EP treatment period.|15-30 minutes after the injection|ITT. 1 measurement was taken in all participants at the start of the CS/EP labelled treatment period (CS/ADJ labelled treatment was experimental and will not be used for the future commercial drug, so no measurements were taken). Note: Only 59 of the 62 participants had valid recovery data.|||Kg/dL||Inter-Quartile Range|Median
1427669|NCT01029340|Primary|Part B - Annualized Number of Total Bleeds|The annualized number of bleeds experienced by participants|12 months after randomization|Intent to treat (ITT)|||Bleeds||Inter-Quartile Range|Median
1427670|NCT01029340|Primary|Part A - Half-life (t 1/2)|To examine the PK characteristics of BAY81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.|PK Analysis Population|||Hours (h)||Geometric Coefficient of Variation|Geometric Mean
1427671|NCT01029340|Primary|Part A - Area Under the Drug Concentration-time Curve (AUC)|To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.|Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.|PK Analysis Population|||Int.units x hours/deciliters (IU*h/dL)||Geometric Coefficient of Variation|Geometric Mean
1427672|NCT01029262|Post-Hoc|Percentage of Participants Who Achieved an Erythroid Response Based on Original IWG 2006 Criteria|"A participant was considered as having achieved an erythroid response when:~- a Hgb increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that had also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe can be less than a 1.5 g/dL). The duration of Hgb increase is from the date of a first ≥1.5 g/dL increase to the last date when Hgb value still have a ≥1.5 g/dL increase.~OR~- had an absolute reduction of 4 RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.~The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9.5 g/dL or less may be used in this response assessment."|Up to 49 months; from randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Intent to treat population includes all participants who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
1427673|NCT01029262|Secondary|Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations, Concomitant Procedures/Surgeries and the Differences Between Treatment Arms|HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.|Up to 5 years||2019-05-31|05/2019||||
1427674|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."|||percentage of participants|||Number
1427712|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 15|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427675|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point (indicated by n) are included."|||percentage of participants|||Number
1427676|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A change of at least 10 points on the standardized domain scores was required for it to be considered clinically meaningful.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment with the EORTC QLQ-C-30. Only those with available data at baseline and each time point (indicated by n) are included."|||percentage of participants|||Number
1427677|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom). Improvement means at least 10 points better compared to baseline."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||percentage of participants|||Number
1427678|NCT01029262|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. Improvement means at least 10 points better compared to baseline|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."|||percentage of participants|||Number
1427679|NCT01029262|Secondary|Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n ) are included."|||units on a scale||95% Confidence Interval|Least Squares Mean
1428696|NCT01019707|Primary|Systolic Blood Pressure|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion||||mm Hg|Timepoints|Standard Deviation|Mean
1427680|NCT01029262|Secondary|Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||95% Confidence Interval|Least Squares Mean
1427681|NCT01029262|Secondary|Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Physical Functioning was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement.|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||95% Confidence Interval|Least Squares Mean
1427682|NCT01029262|Secondary|Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||95% Confidence Interval|Least Squares Mean
1427683|NCT01029262|Secondary|Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom).|Baseline, Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||95% Confidence Interval|Least Squares Mean
1427684|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Emotional Functioning Domain was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||Standard Deviation|Mean
1427713|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 10|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427685|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in Global Health Status/QOL and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||Standard Deviation|Mean
1427686|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Physical Functioning Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||Standard Deviation|Mean
1427687|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate decreased dyspnea (i.e. improvement in symptom) and positive values indicate increased dyspnea (i.e. worsening of symptom)."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n are included)."|||units on a scale||Standard Deviation|Mean
1427688|NCT01029262|Secondary|Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24|"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reduction in fatigue (i.e. improvement in symptom) and positive values indicate increases in fatigue (i.e. worsening of symptom)."|Baseline and Week 12, ±3 days and Week 24, ±3 days|"Analyses were performed based on the HRQoL evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Only those with available data at baseline and each time point (indicated by n) are included."|||units on a scale||Standard Deviation|Mean
1427689|NCT01029262|Secondary|Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48|The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspnea, insomnia, appetite, constipation, diarrhea, financial difficulties). Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher score on symptom scales indicating worse symptoms. A participant was considered compliant at a visit if at least 15 out of the QLQ-C30 items in the questionnaire were checked.|Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014|Analyses were performed based on the Health Related Quality of Life (HRQoL) evaluable population, defined as all randomized participants who completed the baseline assessment and at least one post-baseline assessment for the intent to treat population. Data is available up to Week 48 due to small sample after that.|||percentage of participants|||Number
1427697|NCT01029262|Primary|Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|"The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive rolling 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder."|Up to 49 months; Up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Analysis population includes ITT participants with an erythroid gene expression signature with a positive response|||percentage of participants|||Number
1427690|NCT01029262|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|"A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.~A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|From the first dose of study drug through 28 days after discontinuation from the study treatment; up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Safety population includes all patients who received at least 1 dose of study drug.|||participants|||Number
1427691|NCT01029262|Secondary|Kaplan Meier Estimate for Overall Survival (OS)|Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive.|Up to 49 months; From randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|Intent to treat population was all participants who were randomized.|||years||95% Confidence Interval|Median
1427692|NCT01029262|Secondary|Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML)|Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact.|Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure to study drug was 1158 days|Intent to treat population includes all participants who were randomized and received either Lenalidomide or Placebo. One participant in the placebo arm was diagnosed as having AML before enrollment and was excluded from all analyses of progression to AML.|||years||95% Confidence Interval|Median
1427693|NCT01029262|Secondary|Time to 56-Day RBC-Transfusion-independent Response as Determined by the Sponsor|The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period – the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.|From the first dose of study drug to Day 56|The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.|||weeks||Full Range|Median
1427694|NCT01029262|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on Modified International Working Group (IWG) 2006 Criteria|"A participant was considered as having achieved an erythroid response if the participant either:~- had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less <1.5 g/dL). The duration of Hgb increase is from the date of a first ≥1.5 g/dL increase to the last date when Hgb value still have a ≥1.5 g/dL increase.~OR~- had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline transfusion burden.~The baseline transfusion burden is the number of units over 112 days by the randomization divided by 2. Only transfusions given for a pre-transfusion Hgb value of 9 g/dL or less may be used in this response assessment."|Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure on study drug was1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.|||percentage of participants|||Number
1427695|NCT01029262|Secondary|Kaplan Meier Estimates of Duration of 56-day RBC TI Response as Determined by the Sponsor|"The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):~for those who received a subsequent RBC transfusion after the response starts, the duration of response was not censored, and was calculated as response duration = last day of response – first day of response +1 where the last day of response was defined as 1 day before the first RBC transfusion which was given at 56 days or more after the response starts.~for those who did not receive a subsequent RBC transfusion after the response started, the end day of the response was censored and duration of the response was calculated as response duration = date of last RBC transfusion assessment – first day of response+ 1. A responder was a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first study drug treatment period"|Up to 49 months; from randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The analysis was conducted only for those participants who achieved a 56-day TI response according to the sponsor's assessment. Responders in the intent to treat population.|||weeks||95% Confidence Interval|Median
1427696|NCT01029262|Secondary|Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor|The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive “rolling” 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.|Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.|||percentage of participants|||Number
1428697|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Leading to Hospitalization||48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||participants|||Number
1427698|NCT01029262|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)|The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive “rolling” 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose|Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days|The Intent-to-Treat (ITT) population includes all participants who were randomized to either Lenalidomide or placebo.|||percentage of participants|||Number
1427699|NCT01029054|Primary|The Percentage of Patients That Achieve a Response to Treatment|"The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined.~sCR is defined as:~Negative immunofixation on the serum and urine and~Disappearance of any soft tissue plasmacytomas and~< 5% plasma cells in bone marrow and~Normal SFLC ratio and~Absence of clonal cells in bone marrow~VGPR is defined as:~Serum and urine M-protein detectable by immunofixation but not on electrophoresis or~≥ 90% reduction in serum M-component with urine M-component < 100 mg per 24 hours~PR is defined as:~≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours~If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required"|4 Months After Treatment Start||||percentage of patients|||Number
1427700|NCT01029054|Secondary|The Percentage of Patients Alive Without Progression|"The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment.~Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia."|12 Months and 24 Months Post Treatment||||percentage of patients|||Number
1427701|NCT01029054|Primary|The Maximum Tolerated Dose (MTD) of Carfilzomib|Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months.|6 Months|Of the 53 patients enrolled, 35 were entered into the Phase I portion of the study.|||mg/m^2|||Number
1427702|NCT01028911|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||hours||Full Range|Median
1427703|NCT01028911|Secondary|Maximum Plasma Concentration (Cmax) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||ng/mL||Standard Deviation|Geometric Mean
1427704|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Donepezil||0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||ng*hr/mL||Standard Deviation|Geometric Mean
1427705|NCT01028911|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||hours||Full Range|Median
1427706|NCT01028911|Secondary|Maximum Serum Concentration (Cmax) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||nanogran per millileter (ng/mL)||Standard Deviation|Geometric Mean
1427707|NCT01028911|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-03654746||0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest during the study.|||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1427708|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Follow-up|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427709|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 30|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427710|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 25|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427711|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 20|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427714|NCT01028911|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 5|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427715|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Follow-up|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427716|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 30|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 30|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427717|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 25|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 25|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427718|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 20|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 20|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427719|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 15|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 15|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427720|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 10|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 10|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427721|NCT01028911|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 5|NPI: 12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Day 5|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427722|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Follow-up|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Follow-up (7 to 10 days after last dose)|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427723|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 30|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 30|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427724|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 25|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427725|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 20|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427726|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 15|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427727|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 10|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427728|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Day 5|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427729|NCT01028911|Primary|Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline|Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score.|Baseline|Safety population included all participants who took at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1427730|NCT01028911|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
1427731|NCT01028911|Primary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/>1.5*upper limit of normal [ULN]); platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN/>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN/>1.1*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs), urine epithelial cells (>=6 high-powered field), urine bacteria >20 high-powered field; qualitative urine glucose, ketones, protein values >=1 in urine dipstick test. Total number of participants with any laboratory abnormalities was reported.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
1427732|NCT01028911|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of >=300 milliseconds (msec), maximum QRS interval >=200 msec, maximum fridericia’s corrected QT (QTcF) interval >=500 msec, PR interval or QRS interval increase from baseline >=25 percent (%) or 50 percent (%), QTCF interval increase from baseline 30 to 60 msec or >=60 msec.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
1427733|NCT01028911|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (SBP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm, standing pulse rate <40 bpm or >140 bpm. Maximum increase or decrease from baseline in supine (Su) and standing (St) SBP >=30 mmHg and maximum increase or decrease from baseline in supine and standing DBP >=20 mmHg.|Baseline up to 7 to 10 days after last dose|Safety population included all participants who took at least 1 dose of study drug.|||participants|||Number
1427734|NCT01028820|Primary|Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version|The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS—PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant.|"Baseline (Pre-Dose) to 8 Weeks (Post-Dose)"|All randomized participants' scores were analyzed using the PDD-CYBOCS measure. Higher values reflect worse outcomes. Subscales are added to compute the total score (total score does not include compulsion free-interval and peculiarity of the behavior.|||Scores on a scale||Standard Deviation|Mean
1427735|NCT01028820|Secondary|Total Repetitive Behavior Scale - Revised (RBS_R)|"The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales.~The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129."|baseline week 0, 8 weeks|All randomized participants' scores were analyzed using the RBS-R measure. Higher values reflect worse outcomes (greater symptom severity). Subscales are added to compute the total score.|||units on a scale||Standard Deviation|Mean
1427736|NCT01028677|Primary|Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks|"The Interpersonal Reactivity Index (IRI; Davis, 1983) is a self-report measure of cognitive and affective empathy. The IRI consists of 28 items where participants rate how well each item describes them using a five-point scale (1 to 5). The 28 items yield four subscales: perspective taking (PT), empathic concern (EC), fantasy (F), and personal distress (PD). Higher scores indicate a greater empathic response.~Score range for IRI: min, max Total: 28, 140 PT: 7, 35 EC: 7, 35 F: 7, 35 PD: 7, 35"|6 weeks||||rating on a scale||Standard Deviation|Mean
1427737|NCT01028677|Primary|Social Perception as Measured by the Trustworthiness Task at 6 Weeks|The Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998) is comprised of 42 black and white photographs of the faces of unfamiliar people. Participants are shown each picture individually (on a computer monitor) and asked to rate how much they would trust that person (e.g., with their money) on a seven-point scale, ranging from -3 (very untrustworthy) to +3 (very trustworthy). They are provided with a photograph of 0 or an average face (i.e., someone they would neither trust nor distrust) to refer to throughout the task (based on Adolphs et al.’s, 1998 norms). The total score is the sum of the trustworthiness ratings. Possible range is -126 to 126.|6 weeks||||rating on a scale||Standard Deviation|Mean
1427738|NCT01028677|Primary|Theory of Mind as Measured by the Brune Test at 6 Weeks|In The Brune Test (Brune, 2003), participants are shown a series of six sets of four cartoon pictures that illustrate interactions between two or more individuals. The cartoon cards were displayed to the participant in a predetermined scrambled order. Participants are asked to rearrange the pictures in an order that conveys a logical story. After the participant arranges the cards, the examiner ensures they are in the correct sequence. If they are not in the correct order, the examiner silently arranges them so they are in the logical sequence.The participant’s interpretations of the characters’ beliefs are scored as correct or incorrect (zero or one), with higher scores indicating better Theory of Mind. The sum of correct answers is the outcome of interest. The participants can receive a maximum total of 23 points for the questions.|6 weeks||||correct responses||Standard Deviation|Mean
1428698|NCT01019694|Secondary|Number of Patients Having Chronic Obstructive Pulmonary Disease (COPD) Exacerbations||48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||participants|||Number
1427739|NCT01028677|Primary|Theory of Mind as Measured by the Eyes Test at 6 Weeks|The Eyes Test (Baron-Cohen, Wheelwright, Hill, Raste, & Plumb, 2001) consists of 36 photographs where participants are asked to guess the mental state (i.e., what the person is thinking or feeling) from among four choice words. Participants are given a practice item to ensure that they understand the task. Each eye region is displayed on a computer screen with the four choice mental states shown in the four corners of the computer screen (one target word and three foil words). The score range is 0 (no correct responses) to 36 (all stimuli are correctly identified).|6 weeks||||correct responses||Standard Deviation|Mean
1427740|NCT01028677|Secondary|Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks|"The PANSS consists of 30 items (7 positive psychotic symptoms, 7 negative psychotic symptoms, 16 general psychopathology symptoms) on which subjects are rated (1-7) based upon a semi-standardized interview. Higher scores indicate more/greater symptoms (i.e., greater symptoms of psychosis) and lower scores indicate fewer symptoms (better outcome).~Possible score range: min, max Total: 30,210 Positive symptoms:7, 49 Negative symptoms:7, 49 General symptoms: 16,112"|6 weeks||||rating on a scale||Standard Deviation|Mean
1427741|NCT01028677|Primary|Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point|"The Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, & Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified).~The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity."|6 weeks||||number of correct responses||Standard Deviation|Mean
1427742|NCT01028651|Secondary|Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24|NT-proBNP was assessed at Baseline, Weeks 12 and 24.|Baseline to Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||pg/mL||Full Range|Median
1427743|NCT01028651|Secondary|Change in Quality of Life From Baseline to Weeks 12 and 24|The 36-item Short Form Survey (SF-36) is a health related quality of life instrument, which measures dimensions of physical and social roles and functioning, mental health, vitality, and pain. Items are scored on a 0 to 100 range so that the lowest scores represent the highest disability. The quality of life assessment was conducted at Baseline and Weeks 12 and 24 and the change from Baseline to Weeks 12 and 24 is presented.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||units on a scale||Full Range|Median
1427744|NCT01028651|Secondary|Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||cm||Full Range|Median
1427745|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||mmHg||Full Range|Median
1427746|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||mm||Full Range|Median
1427747|NCT01028651|Secondary|Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24|Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24.|||cm2||Full Range|Median
1427748|NCT01028651|Secondary|Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24.|The 6-Minute Walk Test was conducted at Screening, Baseline prior to starting study drug and at least 24 hours after the Screening test, and during the Treatment Phase at Weeks 12 and 24.|Baseline and Weeks 12 and 24|All subjects with data available at Baseline and Weeks 12 and 24|||Meters||Full Range|Median
1427749|NCT01028651|Secondary|Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24|The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24|||Wood Units||Full Range|Median
1427750|NCT01028651|Secondary|Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24|The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24|||percentage bound to hemoglobin||Full Range|Median
1427751|NCT01028651|Secondary|Change in Cardiac Output at Rest From Baseline to Week 24|The change in cardiac output was evaluated at rest from Baseline to Week 24. The median change in cardiac output from Baseline to Week 24 is presented.|24 weeks|All subjects with data available at Baseline and Week 24|||L/min||Full Range|Median
1427752|NCT01028651|Secondary|Change in Heart Rate at Rest From Baseline to Week 24|The change in heart rate was evaluated at rest from Baseline to Week 24.|24 weeks|All subjects with data available at Baseline and Week 24|||beats/min||Full Range|Median
1427772|NCT01028222|Secondary|OS Rate|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Percentage of participants|||Number
1427753|NCT01028651|Secondary|Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24|The change in hemodynamic parameters (including systolic pulmonary arterial pressure [PAPs], diastolic pulmonary arterial pressure [PAPd], mean pulmonary arterial pressure [mPAP], and transpulmonary gradient [TPG]) was evaluated at rest from Baseline to Week 24. The median change in hemodynamic parameters from Baseline to Week 24 via right-heart catheterization (RHC) is presented.|24 weeks|All subjects with data available at Baseline and Week 24|||mmHg||Full Range|Median
1427754|NCT01028651|Primary|Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24.|The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH).|24 Weeks|The total number of subjects enrolled and analyzed.|||participants|||Number
1427755|NCT01028391|Secondary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Fasting Plasma Glucose (FPG) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Baseline and Week 54|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the extension study. For FAS patients with no data at Week 54, the last observed measurement during extension study was carried forward to Week 54.|||mg/dL||95% Confidence Interval|Least Squares Mean
1427756|NCT01028391|Primary|Change From Baseline (i.e., Week 0 of the 24-week Base Study) in Hemoglobin A1c (HbA1c) at Week 54|HbA1c is measured as percent. Thus this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and 54 Weeks|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 value for this outcome during the 30-week extension study. For FAS patients with no data at Week 54, the last observed measurement during the 30-week extension study was carried forward to Week 54.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
1427757|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427758|NCT01028378|Primary|Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427759|NCT01028378|Primary|Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427760|NCT01028378|Primary|Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427761|NCT01028378|Primary|Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427762|NCT01028378|Primary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427763|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427764|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427765|NCT01028378|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D||12 month||||Percentage of Eyes|Participants|95% Confidence Interval|Number
1427766|NCT01028352|Secondary|Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)|A secondary measure is the percentage of patients treated with duloxetine who experience a sustained 30% reduction in average pain score from baseline to 8 weeks. Sustained 30% reduction is defined as at least 30% reduction in 24-hour average pain severity at the 8 week endpoint, with a 30% reduction from baseline at a visit at least 2 weeks prior to the last visit, and at least 20% reduction from baseline at every visit in between.|Baseline, 2, 4 , 6 and 8 weeks||||%of participants with 30% pain reduction||95% Confidence Interval|Number
1427767|NCT01028352|Primary|Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.|Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory & reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.|8 weeks|Subjects were considered evaluable for the primary endpoint if they met all eligibility criteria and took at least one dose of duloxetine|||percentage of participants|||Number
1427768|NCT01028300|Secondary|No Implant Related Complications||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
1427769|NCT01028300|Secondary|No Re-operations, Revisions, Removals or Supplemental Fixation||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
1427770|NCT01028300|Secondary|Time to Return to Active Duty||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
1427771|NCT01028300|Primary|The Primary Endpoint of This Study is the Assessment of the Mean Oswestry Low Back Pain Disability Questionnaire (ODI) Improvement at the Twelve (12) Month and Twenty-four (24) Month Follow-up Visits Relative to Baseline.||24 months|Study was terminated early due to slow enrollment. 1 subject was enrolled but not treated due to study termination. 1 subject was enrolled and treated, but had no follow-up visits due to study termination. Only Two subjects were seen for follow-up visits, and only at 3 months post surgery.||||||
1427773|NCT01028222|Secondary|PFS Rate|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Percentage of participants|||Number
1427774|NCT01028222|Secondary|Disease Control Rate (DCR)|DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Participants|||Number
1427775|NCT01028222|Secondary|Time to Objective Response (TOR)|TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||months||95% Confidence Interval|Median
1427776|NCT01028222|Secondary|Overall Survival (OS)|OS was defined as the time from the date of the start of treatment to the date of death due to any cause.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Months||95% Confidence Interval|Median
1427777|NCT01028222|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Months||95% Confidence Interval|Median
1427778|NCT01028222|Secondary|Durable Overall Response Rate (DORR)|DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Participants|||Number
1427779|NCT01028222|Primary|Overall Response Rate (ORR)|ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.|End of study (up to 39 months)|Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.|||Participants|||Number
1427780|NCT01028131|Primary|Urinary Cotinine|Cotinine, as measured by urine sample taken and follow-up. Measured as number of participants abstinent by cotinine analysis.|8 week follow-up||||participants|||Number
1427781|NCT01028131|Primary|Smoking Behavior (Self-report Confirmed by Expired Breath CO)|All participants were analyzed as assigned. Total N was determined primarily by resource availability in this Stage Ib trial. Number represents number of abstinent participants in each condition.|8 week follow up||||participants|||Number
1427782|NCT01028053|Secondary|The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer’s Disease (pAD) Within the Follow up Period.|Numbers of subjects with normal and abnormal patterns of [18F]flutemetamol uptake who converted to pAD.|Up to 36 months post flutemetamol administration.|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).|||Number of subjects|||Number
1427783|NCT01028053|Primary|Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer’s Disease Based on Visual Image Interpretation.|"Visual Interpretation of the PET scan by independent readers.~Note: The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.~As the HR increases above 1, the chances of being probable Alzheimer’s Disease (pAD) also increases.~Note: Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included)."|Up to 36 months post flutemetamol administration|Eight Subjects who withdrew prior to the first Clinical Adjudication Committee (CAC) evaluation are not included in the analysis. (232 – 8 = 224 Subjects included).|||Ratio of visual interpretations|||Number
1427784|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.|Baseline, Day 3|The ITT population was used for this secondary efficacy parameters.|||Score on a scale||Standard Deviation|Mean
1427785|NCT01028027|Secondary|Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population|The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.|Baseline, Day 3|The PP population was used for this secondary efficacy parameters.|||Score on a scale||Standard Deviation|Mean
1427786|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population|The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 8|The ITT population was used in this secondary efficacy parameter.|||Score on a scale||Standard Deviation|Mean
1427787|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population|The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.|Baseline, Day 8|The PP population was used for this secondary efficacy parameters.|||Score on a scale||Standard Deviation|Mean
1427788|NCT01028027|Secondary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population|The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population|Baseline, Day 15|The ITT population was used in this secondary efficacy parameter.|||Score on a scale||Standard Deviation|Mean
1427789|NCT01028027|Primary|Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population|The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).|Baseline, Day 15|The PP population was the population used for the primary efficacy analysis.|||Scores on a scale||Standard Deviation|Mean
1427790|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry|Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.|||milliliters per second||Inter-Quartile Range|Median
1427791|NCT01028014|Other Pre-specified|Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.|Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.|||Milliamps||Inter-Quartile Range|Median
1427792|NCT01028014|Primary|Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG|Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.|2 weeks|The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.|||microvolts||Inter-Quartile Range|Median
1427793|NCT01027910|Secondary|Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration.||2 years||||participants|||Number
1427794|NCT01027910|Secondary|Number of Partial Responses (PR)|number of patients who demonstrated partial response to therapy as determined by RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year||||participants|||Number
1427795|NCT01027910|Secondary|Dose Limiting Toxicities|number of patients who experienced dose limiting toxicities|1 year||||participants|||Number
1427796|NCT01027910|Primary|Maximum Tolerated Dose||up to 30 days after starting study drugs|The two groups differ in that GCSF was offered if clinically indicated in arm 1 while it was administered to all participants in arm 2.|||mg/m2|||Number
1429724|NCT01012167|Secondary|Laboratory Measures - A/G Ratio|Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant date for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
1427799|NCT01027897|Primary|Volume of Distribution (Vd)|The Volume of distribution is the calculated volume that the given amount of drug is uniformly distributed in the body to achieve a particular concentration|After 3rd dose of study medication|Patients that completed the study and did not have atypical variations in the measurement of serum concentrations were included in the final evaluation|||liters||Standard Deviation|Mean
1427800|NCT01027884|Secondary|Percentage of Patients Reporting Adverse Events||52 Weeks||||percentage of patients reporting AEs|||Number
1427801|NCT01027884|Secondary|Change From Baseline to Week 52 in Quality of Life Assessed by PedsQL™ Paediatric Quality of Life Inventory|"PedsQL Quality of Life Inventory contains paediatric HRQOL measurements: Physical, Emotional,Social and School Functioning.~Item Scaling:~5-point Likert scale from 0 (Never) to 4 (Almost always). 3-point scale: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Young Child (ages 5-7).~Scores are transformed on a scale from 0 to 100 ( 0=100, 1=75, 2=50, 3=25, 4=0) Total Score: Sum of all the items over the number of items answered on all the Scales.~The values reported below are overall scores on Paediatric Quality of Life Inventory in Child/Teen Report. These scores were obtained by averaging scores for all the described subscales. The overall scores range between 0-100 with 0 = worst outcome and 100= best outcome"|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with Baseline assessments.|||units on a scale||95% Confidence Interval|Mean
1427802|NCT01027884|Secondary|Change From Baseline to Week 52 in Muscle Strength|"The change from Baseline to Week 52 in muscle strength as measured by Hand-Held Myometry (HHM) was performed following standardized procedures. As almost all patients were non-ambulatory, only analyses of upper limb muscle strength were performed. Results for elbow flexors and for elbow extensors are reported below.The highest value of 3 consecutive measurements with an interval of at least 10 seconds were recorded.~The HHM was measured using MicroFET2, a digital hand held muscle tester. The selected unit of measure was Newtons (N)."|Baseline and Week 52|The number of patients (N) in each treatment group is the number of patients with baseline assessments|||Newtons||95% Confidence Interval|Mean
1427803|NCT01027884|Secondary|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.|||percentage of Predicted FVC||95% Confidence Interval|Mean
1427804|NCT01027884|Primary|Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Change from Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 52|Baseline and Week 52|This analysis was performed on the ITT population(n=64). This population included all randomized patients who received at least one dose of the study medication and provided at least one post-Baseline assessment. It excluded siblings who had been allocated to the same study treatment as a randomized sibling.|||percentage||95% Confidence Interval|Geometric Mean
1427805|NCT01027871|Secondary|Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; interaction between visit and treatment; and a random effect for participant.|Baseline and Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
1427806|NCT01027871|Secondary|Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.|Baseline through Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance.|||Number of Hypoglycemia episodes/30 days||Standard Deviation|Mean
1427807|NCT01027871|Secondary|Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Baseline through Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance.|||percentage of participants|||Number
1427808|NCT01027871|Secondary|Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms|LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 2 and Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/kg||Standard Error|Least Squares Mean
1427809|NCT01027871|Secondary|8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
1427810|NCT01027871|Secondary|Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF).|||percentage of participants|||Number
1427811|NCT01027871|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, last observation carried forward (LOCF).|||percentage of participants|||Number
1427812|NCT01027871|Secondary|Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
1427813|NCT01027871|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms|FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 algorithm 1, LY2605541 algorithm 2, glargine); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug, excluding those on LY2605541 prior to the changes in the dosing guidance, with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
1427814|NCT01027871|Secondary|Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint|The drug (LY2605541) concentration at steady state (Css) is calculated from the clearance (Liter/hour) and the final dose of the participants. Clearance was estimated using population-based approaches.|Week 12|Participants who took at least one dose of study drug and had measurements at Week 12.|||picomoles per liter (pMol/L)||Geometric Coefficient of Variation|Geometric Mean
1427815|NCT01027871|Secondary|Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12|Within-patient glycemic variability was assessed as the standard deviation of fasting blood glucose each day at baseline, and each day between Week 10 and Week 12. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Baseline and Week12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||nmol/L||Standard Error|Least Squares Mean
1427816|NCT01027871|Secondary|Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16|Negative is defined as either 'negative' from lab or percent binding <1.16%. Positive is defined as the percent binding is ≥1.16%. The antibody status change is from negative to positive or positive to negative.|Week 12 and Week 16|All randomized participants who took at least one dose of study drug with both baseline and endpoint antibody measurements.|||percentage of participants|||Number
1427817|NCT01027871|Secondary|Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]). Hypoglycemia rate per 30 days is calculated as the number of hypoglycemia/number of days at risk*30.|Baseline through Week 12|All randomized participants who took at least one dose of study drug.|||Number of Hypoglycemia episodes/30 days||Standard Deviation|Mean
1427818|NCT01027871|Secondary|Percentage of Participants With Hypoglycemia From Baseline Through Week 12|Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 mmol/L (≤70 mg/dL) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Baseline through Week 12|All randomized participants who took at least one dose of study drug.|||percentage of participants|||Number
1427819|NCT01027871|Secondary|Daily Basal Insulin Dose at Week 2 and Week 12|LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 2 and Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||nanomole per kilogram (nmol/kg)||Standard Error|Least Squares Mean
1427871|NCT01027364|Secondary|Investigators’/Surgeons’ Assessment of Participants’ Response to rFIXFc for Major Surgery|Based on the first assessment of hemostasis by the surgeon/investigator 24 hours or later post-surgery. Scaled responses: Excellent = 1, Good = 2, Fair = 3, Poor/none = 4.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||responses|Major Surgeries||Number
1427820|NCT01027871|Secondary|8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint|8-point SMBG profiles are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean is obtained using MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and a random effect for participant.|Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/L||Standard Error|Least Squares Mean
1427821|NCT01027871|Secondary|Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Hypoglycemia episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a BG level of ≤3.9 millimole/Liter (mmol/L) (≤70 milligram/deciliter [mg/dL]) even if it was not associated with signs, symptoms, or treatment (consistent with current guidelines [ADA 2005]).|Week 12|All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to|||percentage of participants|||Number
1427822|NCT01027871|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All randomized participants who took at least one dose of study drug, last observation carried forward (LOCF). Arms are combined due to|||percentage of participants|||Number
1427823|NCT01027871|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean of the change from baseline is from MMRM approach. MMRM model includes fixed effects of treatment (LY2605541 dose algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group); baseline HbA1c; visit; visit and treatment interaction; and a random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
1427824|NCT01027871|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint|FBG is measured by 8-point SMBG profiles, which are measured at morning FBG, midday pre-meal BG, evening pre-meal BG, 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. LS mean of the change from baseline to 12 weeks is from MMRM approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-IA, post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline HbA1c group); visit; visit and treatment interaction; and random effect for participant.|Baseline, Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||mmol/Liter||Standard Error|Least Squares Mean
1427825|NCT01027871|Primary|Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles|8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis [IA], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c [HbA1c] group); visit; visit and treatment interaction; random effect for participant.|Week 12|All randomized participants who took at least one dose of study drug with non-missing baseline value and at least one non-missing post-baseline value.|||millimoles per Liter (mmol/L)||Standard Error|Least Squares Mean
1427826|NCT01027819|Secondary|Knee Society Score||6 months|||||||
1427827|NCT01027819|Primary|Rotational Angle Between Femur and Tibia||2 weeks|The rotational angle between the femur and tibia was collected by postoperative CT and asssessed between the transepicondylar angle in the femur and the vertical line of the AP axis of the tibia(the line between the insertion of the PCL and the medial 1/3 point of the tibial tuberosity).|||degree||Standard Deviation|Mean
1427828|NCT01027780|Primary|Electroencephalography Measurement|Measurement of alpha asymmetry at the F3/4 (frontal) electrode. Left prefrontal activation has been associated with positive affect, and with higher levels of antibody responses and natural killer cell cytotoxicity.|post-treatment (time 2)|Some subject EEG recordings were excluded from analyses due to reading/equipment factors (e.g., poor signal, external noise) or subject factors (e.g., sleepiness, illness). Subjects were also allowed to opt out of the EEG procedures if desired.|||Log right-log left alpha power||Standard Error|Mean
1427829|NCT01027780|Primary|Trail Making Test|The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively), may be utilized individually, and as a difference (B-A) or ratio (B/A) score. The Trails B/A ratio was used as an index of improvement in executive control throughout the trial, with lower scores indicating better performance.|immediate post-treatment (Time 2)||||Trails B:A score||Standard Error|Mean
1427830|NCT01027780|Primary|IgG Anti-KLH Antibody Response Post-treatment|Immune function--specifically, antibody response to a novel, benign antigen (an antigen to which subjects are immunologically naïve); in this case, keyhole limpet hemocyanin (KLH).|Immediate post-treatment (time 2)||||OD 405 nm||Standard Error|Mean
1427831|NCT01027702|Secondary|Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)|Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.|1 year|Patients who relapsed and received subsequent chemotherapy were no longer followed for infections as these therapies increase the risk of infections.|||participants|||Number
1427832|NCT01027702|Primary|Incidence and Severity of GVHD|Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.|180 days after transplant|Patients that had not had grade II-IV acute GVHD following prophylactic DLI but received therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion prior to Day +180 were considered not evaluable because these therapies may cause or prevent GVHD and affect the determination of this endpoint.|||Participants|||Count of Participants
1427833|NCT01027702|Primary|Number of Participants With Immune Recovery Following Transplantation|Immune recovery was measured by CD4+ cells > 100/μL by Day 120 following transplantation|120 days after transplant|Patients who received subsequent therapy, such as therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion were considered not evaluable as this could interfere with response assessments.|||Participants|||Count of Participants
1427834|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Number of Letters Read Correctly||Standard Deviation|Mean
1427835|NCT01027650|Secondary|Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 12|Safety Population: all patients who received study treatment|||Number of Letters Read Correctly||Standard Deviation|Mean
1427836|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Microns||Standard Deviation|Mean
1427837|NCT01027650|Secondary|Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 12|Safety Population: all patients who received study treatment|||Microns||Standard Deviation|Mean
1427838|NCT01027650|Primary|Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Number of Letters Read Correctly||Standard Deviation|Mean
1427839|NCT01027650|Primary|Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Month 1|Safety Population: all patients who received study treatment|||Number of Letters Read Correctly||Standard Deviation|Mean
1427840|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2|Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye|||Microns||Standard Deviation|Mean
1427841|NCT01027650|Primary|Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.|Baseline, Month 1|Safety Population: all patients who received study treatment|||Microns||Standard Deviation|Mean
1427842|NCT01027598|Secondary|Objective Response Rate (ORR)|The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|18 Months|Includes all patients who were evaluated for response|||percentage of evaluated participants|||Number
1427843|NCT01027598|Secondary|Overall Survival|The length of time, in months, that patients were alive from first date of protocol treatment until death.|18 months|All treated patients|||months||95% Confidence Interval|Median
1427844|NCT01027598|Primary|Progression-free Survival|The length of time, in months, that patients were alive from first date of protocol treatment until worsening of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|14 months|All treated patients|||months||95% Confidence Interval|Median
1427998|NCT01026805|Secondary|Interlace Medical 1st Generation Hysteroscopic Morcellator Cutting Ability - Mean Score|a 10 point scale assessed performance of the Interlace Medical 1st Generation Hysteroscopic Morcellator(“1” = “poor” and “10” = “excellent”).|2-3 months post treatment|All treating physicians completed a survey questionnaire.|||scores on a scale||Full Range|Mean
1427845|NCT01027559|Primary|Hamilton Depression Rating Scale Score at Baseline and 12 Weeks|The patient was rated by a research team member among 17 dimensions/items pertaining to depression symptoms experienced over the last week. Each item is scored from 0 (=absent), up to 2 or 4 (depending on the item). The maximum total score on the assessment, indicating the most severe depression, would be 52. A total score of 0-7 is considered to be normal. Total scores of 20 or higher indicate moderate, severe, or very severe depression. A 50% or greater drop in Hamilton Depression Rating Scale signifies response to treatment.|Baseline and 12 weeks|Numbers may differ from Participant Flow but these are the totals of those participants who had data at this time point for the Hamilton Depression Rating Scale.|||units on a scale||Standard Deviation|Mean
1427846|NCT01027559|Primary|Blood Oxygen-level Dependent Activations During an Emotional Distractor Task Between fMRI Scans of Depressed Participants in the CBT Group and Control Participants.|MRI imaging was completed on 50 participants (26 depressed who were randomized to the CBT group and 24 controls) for this analysis, including fMRI scans to evaluate regional brain activation in depression during an emotional distractor task. Image data from their baseline visit was processed and analyzed to show differences in blood oxygen-level dependent (BOLD) activations between depressed participants in the CBT group and control participants in a priori regions (amygdala and dorsolateral prefrontal cortex) during the task. The specified regions were masked on the images, and voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these masked regions Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region.|baseline visit and 8-week follow-up|fMRI data from a total of 26 depressed participants randomized to receive CBT and 24 control participants was analyzed. The primary aim was to compare depressed and control participants to evaluate regional brain activation during an emotional task, both at baseline and 8-week follow-up. The primary regions analyzed were the amygdala and DLPFC.|||Voxels||Standard Deviation|Mean
1427847|NCT01027468|Secondary|Systemic Complications After Treatment, Central Retinal Thickness||3 years after initial bevacizumab treatment|||||||
1427848|NCT01027468|Primary|Vision||3 years after initial intravitreal bevacizumab treatment|||||||
1427849|NCT01027468|Primary|Vision||3 years after first intravitreal bevacizumab treatment||||logMar||Standard Deviation|Mean
1427850|NCT01027416|Secondary|Total Number of Over-expressed Genes, Across All Participants With Tumor Protein p53-wild Type Breast Tumors That Had RNA Samples Available.|Total number of over-expressed genes, across all participants with tumor protein p53-wild type breast tumors that had ribonucleic acid (RNA) samples available.|2 years|All patients with p53-wild type breast tumors that had RNA samples available|||genes|||Number
1427851|NCT01027416|Primary|Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm|Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm|2 years|All patients with p53-wild type breast tumors|||percentage of positive PLA||Standard Deviation|Mean
1427852|NCT01027364|Primary|Comparison of Annualized Bleeding Rates|Estimated with a factor for arm, based on whole study duration for all participants. Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.|||episodes per participant per year||95% Confidence Interval|Number
1427853|NCT01027364|Primary|Annualized Bleeding Rate|Annualized bleeding episodes = (number of bleeding episodes / number of days in the respective period)*365.25. In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed pharmacokinetic (PK) sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.|||episodes per participant per year||Inter-Quartile Range|Median
1427854|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in D-dimer|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.|||ng/mL||Standard Deviation|Mean
1427855|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Thrombin-antithrombin (TAT) Complex|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.|||ng/mL||Standard Deviation|Mean
1427999|NCT01026805|Secondary|Resected Tissue Weight Per Patient|mean weight of resected tissue per patient|at time of treatment||||g||Full Range|Mean
1427856|NCT01027364|Secondary|Coagulation Parameter: Change From Pre-dose Values in Prothrombin Split Fragments 1+ 2 (F 1+2)|Maximum value post-dosing is defined as maximum value over the 1-, 6-, and 24-hour evaluations.|Pre-dose, 1 hour post-dose, 6 hours post-dose, and 24 hours post-dose at baseline (120 hours before Day 1, for BeneFIX), Day 1, Week 26, and Week 52 (for rFIXFc)|The Sequential PK subgroup consisted of all participants who had evaluable PK profiles for both BeneFIX and baseline rFIXFc, and/or evaluable PK profiles for both baseline and repeat rFIXFc at Week 26 (±1 week). n=participants with an assessment at given time point.|||pmol/L||Standard Deviation|Mean
1427857|NCT01027364|Secondary|Number of Participants With Clinically Relevant Abnormalities or Relevant Changes From Baseline in Vital Signs|Number of participants with clinically relevant abnormalities or relevant changes from baseline in temperature, pulse (beats per minute [bpm]), systolic blood pressure (SBP), and diastolic blood pressure (DBP) are presented. Baseline (BL) is defined as the last non-missing evaluable assessment taken prior and closest to the first rFIXFc dose. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; a table was not generated for participants in the perioperative management/surgical arm (Arm 4). n=participants with a baseline assessment and at least one post-baseline assessment for temperature or at least one post-baseline assessment for pulse, SBP, and DBP.|||participants|||Number
1427858|NCT01027364|Secondary|Time to 1% and 3% FIX Activity|Time to reach 1 or 3 IU/dL (%) after a single dose. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||days||95% Confidence Interval|Geometric Mean
1427859|NCT01027364|Secondary|Incremental Recovery|IU/dL rise in plasma per IU/kg drug administered. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
1427860|NCT01027364|Secondary|Volume in Steady State (Vss)|Volume of distribution at steady state. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||mL/kg||95% Confidence Interval|Geometric Mean
1427861|NCT01027364|Secondary|Mean Residence Time (MRT)|The average time for all the drug molecules to reside in the body. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||hours||95% Confidence Interval|Geometric Mean
1427872|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Children (Haemo-QoL) Questionnaire: Change From Baseline to Week 26 and Week 52|The Haemo-QoL, a quality of life (QoL) assessment instrument for children and adolescents with hemophilia, was administered to participants from 13- to 17-years-old. This instrument assesses domains specific to living with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline, Week 26, Week 52|No summary analysis was done for this outcome measure due to the small number of participants completing the questionnaire.||||||
1427862|NCT01027364|Secondary|Clearance (CL)|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||mL/h/kg||95% Confidence Interval|Geometric Mean
1427863|NCT01027364|Secondary|Half Life (t1/2) Alpha and t1/2 Beta|Time required for the concentration of the drug to reach half of its original value. Alpha and beta half-life indicate distribution and elimination half-life in a two-compartment PK model. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||hours||95% Confidence Interval|Geometric Mean
1427864|NCT01027364|Secondary|Area Under the Curve (AUC) Per Dose|Dose normalized area under the drug concentration-time curve. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
1427865|NCT01027364|Secondary|Maximum Concentration (Cmax)|Maximum concentration during a dosing interval. Assessment of FIX activity with BeneFIX was conducted following a required 120-hour (5-day) washout period, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 72 (±3) hours, and 96 (±3) hours (4 days) from the start of the injection. Assessment of FIX activity and rFIXFc concentration was conducted following the initial dose of rFIXFc (after a required 120-hour [5-day] washout period) and at Week 26, at these timepoints: predose, 10 (±2) minutes, 1 hour (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 24 (±2) hours, 48 (±2) hours, 96 (±3) hours (4 days), 144 (±3) hours (6 days), 168 (±3) hours (7 days), 192 (±3) hours (8 days), and 240 (±3) hours (10 days) from the start of the injection.|See Measure Description for complete time frame. Each participant was to complete PK sampling up to, and including, the 96-hour (4-day) timepoint for BeneFIX PK assessment and the 240-hour (10-day) timepoint for rFIXFc PK assessment.|Participants in the Sequential PK Subgroup who have evaluable PK profiles for both BeneFIX and baseline rFIXFc.|||IU/dL||95% Confidence Interval|Geometric Mean
1427866|NCT01027364|Secondary|Number of Transfusions Required Per Surgery|Number of blood component transfusions during a single surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||surgeries|Major Surgeries||Number
1427867|NCT01027364|Primary|Incidence Rate of FIX Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. The incidence rates along with the 95% CI were summarized for all titers for subjects with 50 or more exposure days (EDs) to rFIXFc and a valid inhibitor test after the 50th exposure. In addition, the incidence rates for all subjects regardless of their exposure days to rFIXFc were also summarized. The 95% CI was calculated using Clopper-Pearson exact method.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of of rFIXFc and who had a valid inhibitor test; n=number of participants with given number of exposure days who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
1427868|NCT01027364|Secondary|Estimated Total Blood Loss During Major Surgery||up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||mL|Major Surgeries|Full Range|Median
1427869|NCT01027364|Secondary|Dose Per Injection and Total Dose Required to Maintain Hemostasis During Major Surgery|Mean dose per injection is the average dose for all injections (including loading dose) needed to maintain hemostasis during surgery. Total dose is the sum across all injections (including loading dose) needed to maintain hemostasis during surgery.|up to 52 weeks ± 1 week|Participants in Arm 4 who received at least 1 dose of rFIXFc.|||IU/kg|Major Surgeries|Full Range|Median
1429725|NCT01012167|Secondary|Laboratory Measures - Globulin|Globulin blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
1427873|NCT01027364|Secondary|Haem-A-QoL Questionnaire for Adults: Change From Baseline to Week 52|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 52|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
1427874|NCT01027364|Secondary|Hemophilia-Specific Quality of Life Index for Adults (Haem-A-QoL) Questionnaire: Change From Baseline to Week 26|The Haem-A-QoL consists of items pertaining to 10 domains specific to living with hemophilia and was administered to adult participants (> 17 years). The areas covered by this instrument are: physical health, feeling, view of yourself, sports/leisure, school/work, dealing with hemophilia, and treatment (all 7 domains, during the last month) and future, family planning, and outlook for the future (all 3 domains, recently). Changes from baseline for the Haem-A-QoL questionnaire are summarized by prestudy treatment regimen (pooled for Arms 1 and 2). Lower scores represent better QoL; therefore, a negative change from baseline represents improvement during the course of the study. Scores on a scale range between 0 and 100.|Baseline, Week 26|Full Analysis Set: participants in the 2 prophylaxis arms (Arms 1 and 2) over 17 years of age who received at least 1 dose of rFIXFc and had an assessment. n=participants who had specified assessment at given timepoint.|||units on a scale||Full Range|Median
1427875|NCT01027364|Secondary|Total Dose Per Injection Required for Resolution of a Bleeding Episode by Location of Bleed|For each bleeding episode at one location, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for dose administered to resolve that bleeding episode but are included in the individual summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had complete information on the dose administered to treat a bleeding episode; n=total number of bleeding episodes at this location.|||IU/kg||Inter-Quartile Range|Median
1427876|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode by Location of Bleed|Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window were counted. The resolution of a bleed was defined as no sign of bleeding following injection for the bleed. Bleeding episodes that presented in multiple locations are included as a single event in the overall summary for the number of injections to resolve that bleeding episode but are included in summaries for each location.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had a bleeding episode, and had evaluable efficacy assessments; n=total number of bleeds at given location.|||injections||Inter-Quartile Range|Median
1427877|NCT01027364|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|In Arms 1 and 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 and for all surgical/rehabilitation periods in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. All injections given from the initial sign of a bleed until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had at least 1 bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
1427878|NCT01027364|Secondary|Number of Days From Last Injection to Treat a New Bleeding Episode|Please see the definition of the Efficacy Period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A follow-up injection administered >72 hours after the most recent injection given to treat a bleed was considered a new bleed at the same location and was classified as type=Unknown (bleeding episodes of this type were not evaluable). The first bleed for each participant could not be included in this analysis since there was no previous bleed from which to measure time. The number of days from the last injection to treat a bleed to a new bleeding episode was analyzed across all evaluable bleeding episodes per participant.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc and at least 1 evaluable bleeding episode.|||days|Evaluable Bleeding Episodes|Inter-Quartile Range|Median
1428000|NCT01026805|Secondary|Fluid Deficit Per Procedure|mean fluid deficit per procedure. Fluid deficit is the difference between the amount of fluid which is infused into the patient during the hysteroscopic procedure, and the amount of fluid collected at completion of the procedure.|at time of treatment||||mL||Full Range|Mean
1427879|NCT01027364|Secondary|Annualized Bleeding Rate by Location of Bleed (Joint, Muscle, Internal, Skin/Mucosa)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.|||episodes per participant per year||Inter-Quartile Range|Median
1427880|NCT01027364|Secondary|Annualized Bleeding Rate by Type of Bleed (Spontaneous and Traumatic)|Annualized bleeding episodes = (number of bleeding episodes/number of days in efficacy period)*365.25. Please see the definition of the efficacy period (EP) in the Outcome Measure 4 Description. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. A bleeding episode started from the first sign of a bleed, and ended 72 hours after the last treatment for the bleeding, within which any symptoms of bleeding at the same location, or injections less than or equal to 72 hours apart, were considered the same bleeding episode. Any bleeding at a different location was a separate bleeding episode regardless of time from the last injection.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data.|||episodes per participant per year||Inter-Quartile Range|Median
1427881|NCT01027364|Secondary|Average Dosing Interval For the Individualized Interval Prophylaxis Arm|Average dosing interval = sum of days in the included dosing intervals divided by the number of included intervals. Participants could have multiple prophylactic dose interval changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 2, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 2 who received at least 1 dose of rFIXFc with >=6 months on study and evaluable data.|||days||Inter-Quartile Range|Median
1427882|NCT01027364|Secondary|Average Weekly Dose For the Fixed Weekly Interval Prophylaxis Arm|Average weekly dose = (total IU/kg of all eligible prophylactic doses in the included intervals / total number of days in the included intervals)*7. Eligible dose = the first of the 2 doses defining the interval. Participants could have multiple prophylactic dose changes. Prophylactic dosing = from first prophylactic injection received for rFIXFc to the last prophylactic injection on study. Intervals between 2 prophylactic doses separated by a bleed/surgery/PK visit were not included. In Arm 1, the efficacy period (EP) started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries).|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants in Arm 1 who received at least 1 dose of rFIXFc with evaluable data. 'Overall' n=participants with evaluable data; 'Last 3 Months on Study' n=participants with evaluable data and >=6 months on study.|||IU/kg||Standard Deviation|Mean
1427883|NCT01027364|Secondary|Annualized rFIXFc Consumption Per Participant|Consumption is calculated for the efficacy period (EP). In Arms 1 and 2, the EP started with date and time of first prophylactic dose following a completed PK sampling period and ended with last dose administered (for prophylaxis or a bleeding episode). In Arm 3, the EP started following last PK sampling timepoint and ended with either date of last contact or date of last entry into the eDiary, whichever was later. The EP was interrupted for the repeat PK period in Arm 1 (sequential PK subgroup) and for all surgical/rehabilitation periods (for both major and minor surgeries) in all 3 arms. Overall units (IU/kg) of annualized rFIXFc consumption = [Total rFIXFc IU/kg received during the EP / number of days in EP]*365.25.|up to 52 weeks ± 1 week (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc with evaluable data in the efficacy period. 'Overall' n=all participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=all participants in the Full Analysis Set with evaluable data and >=6 months on study.|||IU/kg rFIXFc per participant per year||Standard Deviation|Mean
1427884|NCT01027364|Secondary|Physicians’ Global Assessments of Participants’ Response to Treatment With rFIXFc|Physicians assessed each participant's response to rFIXFc using a 4-point scale: excellent=bleeding episodes responded to less than or equal to the usual number of injections or less than or equal to the usual dose of rFIXFc, or the rate of breakthrough bleeding during prophylaxis was less than or equal to that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis or hemostatic control required additional agents. Percentage of the total count of scale responses for all participants is presented. Multiple responses per participant are counted.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc, had evaluable efficacy assessments, and had nonmissing observations at time point.|||percentage of responses|Responses||Number
1427892|NCT01027351|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, Booster response.|||AU/mL||95% Confidence Interval|Geometric Mean
1427885|NCT01027364|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|up to 52 weeks ± 1 week|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had a bleeding episode; participants with a non-evaluable bleeding episode are counted in the 'number of participants analyzed,' but not the percentages.|||percentage of responses|Bleeding Episodes||Number
1427886|NCT01027364|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period|SAE=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. TESAE=SAE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOC is abbreviated in the table: Injury, Poisoning, and Procedural (IPP).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).|||participants|Participants With At Least 1 TESAE||Number
1427887|NCT01027364|Primary|Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TEAE=AE present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or was not present prior to receiving the first injection but subsequently appeared before last visit on study. Participants are counted once if they report multiple events in the same system organ class (SOC) or preferred term (PT). Coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 15.0 dictionary. The following SOCs are abbreviated in the table: Immune System (IS); Injury, Poisoning, and Procedural (IPP); Metabolism and Nutrition (MN); Musculoskeletal and Connective Tissue (MCT); Respiratory, Thoracic and Mediastinal (RTM); Skin and Subcutaneous Tissue (SST).|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details).|||participants|Participants With At Least 1 TEAE||Number
1427888|NCT01027364|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment, and could be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study product, whether related or not. TE=event present prior to receiving the first injection of BeneFIX or rFIXFc that subsequently worsened in severity or not present prior to receiving the first injection but subsequently appeared before last visit on study. Serious AE (SAE)=AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event. Related=related, possibly related, and relationship missing. Data include AEs emergent during the surgical/rehabilitation period; AE data are included in each treatment arm only for the time each participant was enrolled in that arm.|up to 52 weeks + 30 days ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc. A participant may have been in more than one group (i.e., participants in Arm 4 who were also in Arm 1, 2, or 3; please see Participant Flow for details). Participants with at least one TESAE reported are included in the TEAE count.|||participants|||Number
1427889|NCT01027364|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities|Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint. ULN=upper limit of normal.|up to 52 weeks ± 1 week|Safety Analysis Set: participants who received at least 1 dose of BeneFIX or rFIXFc; n=the number of participants with at least one post-baseline value. For this study, a table was not generated for potentially clinically significant laboratory abnormalities for participants in the perioperative management/surgical arm (Arm 4).|||participants|||Number
1427890|NCT01027351|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age.|The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 & 42 months or 60 & 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after any vaccination|Analysis was done on the MITT – Two Dose Catch Up Schedule population.|||Number of subjects|||Number
1427891|NCT01027351|Secondary|Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age.|The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population population.|||AU/mL||95% Confidence Interval|Geometric Mean
1427893|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 & 42 months .|1 month after each booster/ vaccine dose|The analysis was done on the MITT population, booster response.|||AU/mL||95% Confidence Interval|Geometric Mean
1427894|NCT01027351|Secondary|Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age.|The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post booster; 1 month post dose for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||AU/mL||95% Confidence Interval|Geometric Mean
1427895|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measure using ELISA."|28 months after last Men B vaccination; baseline for naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||AU/mL||95% Confidence Interval|Geometric Mean
1427896|NCT01027351|Secondary|Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after last Men B vaccination; Baseline for Naïve_4042 group|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||AU/mL||95% Confidence Interval|Geometric Mean
1427897|NCT01027351|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age.|The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.|||Percentage of subjects||95% Confidence Interval|Number
1427898|NCT01027351|Secondary|Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age.|The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects.|18-20 months after last Men B vaccine; baseline for naïve_6062|The analysis was done on the MITT, 60 months of age, antibody persistence population.|||Titers||95% Confidence Interval|Geometric Mean
1427899|NCT01027351|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age.|The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|The analysis was done on the MITT population, 2-dose catch-up regimen.|||percentage of subjects||95% Confidence Interval|Number
1427900|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age.|The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.|||Titers||95% Confidence Interval|Geometric Mean
1427901|NCT01027351|Secondary|Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported.|1 month post -vaccine dose two|The analysis was done on the MITT population, 2-dose catch-up regimen.|||Percentages of subjects||95% Confidence Interval|Number
1427902|NCT01027351|Secondary|Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.|||Percentages of subjects||95% Confidence Interval|Number
1427903|NCT01027351|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.|||Percentages of subjects||95% Confidence Interval|Number
1427904|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 & 42 months of age.|1 month post vaccination|The analysis was done on the MITT population, booster response.|||Titers||95% Confidence Interval|Geometric Mean
1427905|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|"The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.~Baseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study."|1 month post - booster/ -dose 1 for Naïve|The analysis was done on the MITT population, booster response.|||Percentage of subjects||95% Confidence Interval|Number
1427906|NCT01027351|Secondary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects .|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.|||Percentage of subjects||95% Confidence Interval|Number
1427907|NCT01027351|Secondary|Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age.|The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.|1 month post- booster/ dose 1 for Naïve|The analysis was done on the MITT population, booster response.|||Titers||95% Confidence Interval|Geometric Mean
1427908|NCT01027351|Secondary|Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age.|The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported.|28 months after vaccination; baseline for naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||percentage of subjects||95% Confidence Interval|Number
1427909|NCT01027351|Secondary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age.|Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after vaccination; Baseline for Naïve|The analysis was done on the MITT, 40 months of age, antibody persistence population.|||Titers||95% Confidence Interval|Geometric Mean
1427910|NCT01027351|Primary|Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age.|The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after booster vaccination|Analysis was done on the safety population i.e all subjects who received at least one Men B vaccination and provided post-baseline safety data.|||participants|||Number
1427911|NCT01027351|Primary|Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age.|"The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after last vaccination; baseline for naïve|The analysis was done on the MITT , 40 months of age, antibody persistence population.|||Percentages of subjects||95% Confidence Interval|Number
1427912|NCT01027351|Primary|Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age.|Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children.|28 months after last vaccination; Baseline for Naïve|The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population.|||Titers||95% Confidence Interval|Geometric Mean
1427913|NCT01027286|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|A scoring system used to evaluate the patient's opinion about his/her knee and associated problems. Subscales include 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation (Sport/Rec), and 5) knee related quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score between 0 to 100 is calculated for each subscale. Subscale scores are generally not combined; rather, they are reported separated. Higher values represent better outcomes (i.e., less extreme symptoms).|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)|||points on a scale||Standard Deviation|Mean
1427914|NCT01027286|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery|Vitagel (n=49 at preoperative, 4 wk, 12 wk); Control (n=50 at preoperative, 4 wk; n=49 at 12 wk since one control subject was lost to follow-up)|||points on a scale||Standard Deviation|Mean
1427915|NCT01027286|Secondary|Length of Stay||day of hospital discharge||||days||Standard Deviation|Mean
1427921|NCT01027273|Secondary|Emotional Health|Number of participants diagnosed as depressed utilizing depression scale. Participant is determined to be depressed if Patient Health Questionnaire (PHQ8) ≥ 10. Scale has a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.|6 months post enrollment into trial||||participants|||Number
1427922|NCT01027273|Secondary|Medication Adherence|"Number of participants adherent to medications as determined with Morisky score ≥ 6 Adherence to medications was measured using the 8-item Morisky Medication Adherence Questionnaire (Morisky). The questionnaire has been validated against an objective measure of adherence and has been used in racially diverse and elderly patient samples. Scores on the questionnaire can be used to classify patients into low and high adherence groups.~Consistent with standard cut points, participants who scored less than 6 points on the Morisky were categorized as nonadherent to medications and participants who scored 6 to 8 points were categorized as adherent."|6 months post enrollment into trial||||participants|||Number
1427923|NCT01027273|Secondary|Knowledge and Attitudes About Stroke Recurrence Risk||6 months post enrollment into trial|||||||
1427924|NCT01027273|Primary|Use of Anti-thrombotic Medication|Number of participants taking anti-thrombotic medication|6 months post enrollment into trial||||participants|||Number
1427925|NCT01027273|Primary|LDL Cholesterol|Percentage of participants with controlled Low Density Lipoprotein low (LDL) of less than 100 mg/dL|6 months post enrollment into trial||||percentage of participants|||Number
1427926|NCT01027273|Primary|Blood Pressure|Percentage of Participants with Blood Pressure controlled at <140/90 mm Hg|6 months post enrollment into trial||||percentage of participants|||Number
1427927|NCT01027195|Secondary|Pain Score Scale|"A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing no pain and 10 representing unbearable pain. Thus, in this context, lower values represent better outcomes."|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery||||points on a scale||Standard Deviation|Mean
1427928|NCT01027195|Secondary|Harris Hip Score (Outcome Score)|A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.|within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery||||points on a scale||Standard Deviation|Mean
1427929|NCT01027195|Secondary|Length of Stay||day of hospital discharge||||days||Standard Deviation|Mean
1427930|NCT01027195|Secondary|Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay|Sum of daily morphine-equivalent mg narcotic usage during hospital stay.|daily during hospital stay (an expected average of 4 days)||||total morphine-equivalent mg||Standard Deviation|Mean
1427931|NCT01027195|Secondary|Change in Hemoglobin Level|Change in hemoglobin level from baseline to the day of hospital discharge.|within 30 days before surgery (preop), day of hospital discharge||||g/dL||Standard Deviation|Mean
1427932|NCT01027195|Secondary|Estimated Blood Loss||Intraoperative (day of surgery)||||mL||Standard Deviation|Mean
1427933|NCT01027195|Primary|Number of Patients Managed With Blood Transfusion||daily during hospital stay (an expected average of 4 days)||||participants|||Number
1427934|NCT01027195|Secondary|Number of Units Transfused||daily during hospital stay (an expected average of 4 days)||||units of blood||Standard Deviation|Mean
1427935|NCT01027000|Secondary|Chimerism for CD3||5 years post-registration|||||||
1427936|NCT01027000|Secondary|Overall Survival||5 years post-registration|||||||
1427937|NCT01027000|Secondary|Treatment-related Mortality||6 months post-transplant|||||||
1427938|NCT01027000|Secondary|Chronic GVHD||5 years post-registration|||||||
1427939|NCT01027000|Secondary|Acute Graft-vs-host Disease (GVHD)||5 years post-registration|||||||
1427940|NCT01027000|Secondary|Response||5 years post-registration|||||||
1427941|NCT01027000|Primary|2-year Progression-free Survival in Early Disease Participants|"Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.~A progression is defined as one of the following events:~>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= 2 cm); appearance of new palpable lymph nodes.~>= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present.~> 50% increase in peripheral blood lymphocytes with an absolute increase > 5000/μL.~Transformation to a more aggressive histology (i.e., Richter’s syndrome or prolymphocytic leukemia with >= 56% prolymphocytes)."|2 years post-registration|Participants with early disease stage were analyzed. Two participants, who did not start protocol therapy, were excluded from this analysis.|||percentage of participants||95% Confidence Interval|Median
1427942|NCT01026974|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age|The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.|Day 1-7 after each vaccination|Analysis was done on the Safety population|||participants|||Number
1427943|NCT01026974|Secondary|Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post dose 2|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Geometric Mean
1428001|NCT01026805|Secondary|Fluid Volume Per Procedure|mean volume of distension fluid infused into the uterus, per procedure. Distention fluid is used to distend the uterus and provide increased visibility.|at time of treatment||||mL||Full Range|Mean
1427944|NCT01026974|Secondary|Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch–up dose of rMenB+OMV NZ in children at 40 months.|1 month post booster / 1 month post dose 1|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
1427945|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age.|18 months post vaccine dose 2|Analysis was done on MITT population|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
1427946|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age.|The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40- & 42- months or 60- & 62- months of age are reported.|1 month post vaccine dose two|Analysis was done on the MITT population.|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
1427947|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age.|20 months post booster/ Baseline for Naïve|Analysis was done on MITT population.|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
1427948|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.|The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch–up dose of rMenB+ OMV NZ in children at 40 months.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
1427949|NCT01026974|Secondary|Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.|"The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with the GMCs in vaccine-naïve children.~GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA)."|28 months after primary vaccination/ Baseline for Naïve|Analysis was done on MITT population.|||concentrations (AU/mL)||95% Confidence Interval|Geometric Mean
1427950|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catch-up doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported.|18 months post vaccine dose two|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
1427951|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.|The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs.|18 months post vaccine dose 2|Analysis was done on the MITT population|||Titers||95% Confidence Interval|Geometric Mean
1427952|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age|The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age.|1 month post vaccine dose 2|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
1427953|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.|The serum bactericidal antibody response in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age are reported as GMTs.|1 month post vaccine dose two|Analysis was done on MITT population|||Titers||95% Confidence Interval|Geometric Mean
1427954|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age|The percentage of subjects with hSBA titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported.|1 month post -vaccine dose two|Analysis was done on MITT population|||percentages||95% Confidence Interval|Number
1427955|NCT01026974|Secondary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age.|20 months post booster/ Baseline for Naïve|This analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
1427956|NCT01026974|Secondary|Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine|The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine –naïve subjects of the same age and reported as GMTs.|20 months post booster/ Baseline for Naïve|Analysis was done on the MITT population|||Titers||95% Confidence Interval|Geometric Mean
1428002|NCT01026805|Secondary|Treatment Time Per Patient|mean morcellation(division into and removal of small pieces, as of tissue) time per patient|at time of treatment||||minutes||Full Range|Mean
1427957|NCT01026974|Secondary|Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|"The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with 4-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects.~Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age for Naive_4042 group."|1 month post booster / 1 month post dose 1 for Naïve|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
1427958|NCT01026974|Secondary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age|The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.|1 month post-booster/ 1 month post-dose 1 for Naïve|Analysis was done on MITT population.|||percentages of subjects||95% Confidence Interval|Number
1427959|NCT01026974|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.|The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.|Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]|Analysis was done on the Safety population- defined as all subjects who received at least one Men B vaccination and provided post-baseline safety data.|||participants|||Number
1427960|NCT01026974|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.|"The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA)."|28 months after primary vaccination; Baseline for Naïve|Analysis was done on MITT population|||percentages of subjects||95% Confidence Interval|Number
1427961|NCT01026974|Secondary|Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age|The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs.|1 month post booster /1 month post dose 1 for Naïve|Analysis was done on MITT population.|||Titers||95% Confidence Interval|Geometric Mean
1427962|NCT01026974|Primary|Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.|The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.|28 months after primary vaccination; Baseline for Naïve|Modified Intention-to-treat (MITT) population was defined as enrolled subjects who actually received at least one vaccine dose,and provided at least one evaluable serum sample both before and after baseline.|||Titers||95% Confidence Interval|Geometric Mean
1427963|NCT01026948|Secondary|Number of Participants Who Were Satisfied With Monitoring at Home|Maternal views were assessed by semi-structured diaries,recording women’s ratings on a 4 point scale (very satisfied, satisfied, slightly disatisfied, very disatisfied)of how well they were coping and their satisfaction with outpatient experience.Women completed diaries at least once every two hours at home.Mean scores were calculated for women’s ratings of coping, comfort satisfaction and location preference. An interpretive approach was utilised for all open responses. Comments made in the free-text spaces of diaries were categorised to contextualise women’s ratings of their experience|6 months|51 women out 70 returned the semistructured diaries. All the diaries were assessed as explained above.|||participants|||Number
1427964|NCT01026948|Primary|Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.|Outpatient induction is when women recieve medication to induce labour at the hospital, but can then go home for monitoring until labour progresses. When 'standard' Doppler Ultrasound FHR technology is used, women may feel restrained as the Doppler-FHR machine (which is bench-top device) is connected to the transducer which is then mounted on the woman's abdomen and attached by an elastic belt, which is known to be uncomfortable for pregnant woman. The AN 24 device is portable and attaches to the patients abdomen allowing remote fetal monitoring whilst the women are at home.|6 months|70 women were recruited to the study, but 8 women were called back to the unit because of signal loss.|||participants|||Number
1427965|NCT01026909|Secondary|Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.||StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits||||steps/day||Standard Deviation|Mean
1427975|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 13.5|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 13.5|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 13.5.|||participants|||Number
1427976|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 9|"Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (Do you ever wake up with an erection) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never)."|Month 9|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 9.|||participants|||Number
1427966|NCT01026909|Primary|Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.|"The Pediatric Outcomes Data Collection Instrument (PODCI) is designed to be completed by the parent/guardian of a child ten years of age or younger who has knowledge of the child's conditions. The eight scales generated from these instruments are:~Upper Extremity and Physical Function Scale; Transfer and Basic Mobility Scale; Sports/Physical Functioning Scale; Pain/Comfort; Treatment Expectations Scale; Happiness Scale; Satisfaction with Symptoms Scale and Global Functioning Scale. The results of each scale are standardized into a scale of 0-100 where 0 indicates the worst outcome and 100 the best.~We decided to report Global Functioning only due to space limitations. Also the Global Functioning scale encompasses items from other scales."|This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits.||||units on a scale||Standard Deviation|Mean
1427967|NCT01026844|Secondary|Correlate Epidermal Growth Factor Receptor (EGFR) Mutations and EGFR Amplification With Response to Treatment in Patients With Available Tumor Specimens.||2 years|Because so few responses were observed, this exploratory outcome was not analyzed||||||
1427968|NCT01026844|Secondary|Objective Tumor Response Rate|Number of Response Evaluation Criteria in Solid Tumors (RECIST) responses divided by number of patients treated. Per RECIST version 1.0 complete response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. The objective tumor response rate is the CR + PR divided by the total number of patients|2 years||||percentage of patients||95% Confidence Interval|Number
1427969|NCT01026844|Secondary|Determine the Pharmacokinetic (PK) Parameters of Hydroxychloroquine (HCQ) Plus Erlotinib.|PK parameter tested was dose normalized minimum steady state concentration (Cmin SS) of HCQ in micromolar per gram. Note this outcome was only analyzed for the first 21 patients enrolled, 13 on erlotinib/HCQ and 8 on HCQ arm.|2 years|The patients participating in the randomized portion of the study were analyzed for PK parameters. When the HCQ alone arm of the study was closed, PK measurements were no longer performed|||micromolar per gram||Standard Deviation|Mean
1427970|NCT01026844|Primary|Describe the Number and Type of Observed Dose Limiting Toxcities|HCQ doses tested included 400mg, 600mg, 800mg, and 1000mg. Dose-limiting toxicities (DLTs) were defined as CTC of grade 2 or higher retinopathy or keratitis, or CTC of grade 3 or higher hematologic, skin, CNS, neuropathic, cardiac, respiratory, gastrointestinal, or renal AEs in the first cycle considered at least possibly related to HCQ. If a DLT was observed, an additional three patients were enrolled at that dose level. The maximum tolerated dose for HCQ in each arm would be defined as one dose level below that at which two or more of 6 patients experienced a DLT, or if no DLTs were observed, the highest tested dose.|2 years|In October 2008, after enrollment of 18 patients (8 on arm A and 10 on arm B), the study was amended to limit enrollment to arm B only (HCQ plus erlotinib) given the increasing preclinical evidence supporting a role for combination therapy (but not HCQ monotherapy) and to help increase overall patient accrual.|||participants|||Number
1427971|NCT01026831|Other Pre-specified|Baseline IOP|IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).|Baseline|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.|||mmHg||95% Confidence Interval|Least Squares Mean
1427972|NCT01026831|Primary|Mean Intraocular Pressure (IOP) Change From Baseline at All 9 Time Points During the Study (0800, 1000 and 1600 Hrs at Weeks 2, 6, and 12)|"IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP).~IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12).~Lowering elevated IOP is a treatment goal of glaucoma."|Baseline, Weeks 2, 6, and 12.|The Per-Protocol (PP) approach excluded all patients with important protocol violations and was performed for the efficacy endpoints. The PP population excluded patients due to important deviations from the protocol that may have substantially affected the results of the primary endpoints.|||mmHg||95% Confidence Interval|Least Squares Mean
1427973|NCT01026818|Secondary|Change in Penile Length and Girth|Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.|Randomization (Baseline), Month 9|All randomized participants who received at least 1 dose of study drug and had penile measurements at Baseline and Month 9.|||millimeter (mm)||95% Confidence Interval|Least Squares Mean
1427974|NCT01026818|Secondary|Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score|EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline EPIC-26 scores measurement at Month 9 and Month 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427996|NCT01026805|Primary|Percentage of Tissue Removed|mean percentage of polyp and fibroid tissue removed, as measured on post-treatment hysteroscopic imaging. Images were obtained immediately post treatment, before the subject left the surgical suite.|immediately post-treatment||||Percentage of tissue removed||Full Range|Mean
1427977|NCT01026818|Secondary|Standardized Morning Erections Question (SMEQ) Score at Month 2|Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ (“Do you ever wake up with an erection”) using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).|Month 2|All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 2|||participants|||Number
1427978|NCT01026818|Secondary|Change From Baseline in ‘Yes’ Answers to Morning Erections|The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant's percentage of “yes” responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.|Randomization (Baseline), Month 10.5|All randomized participants who received at least 1 dose of study drug and had morning erection question answered at Baseline and Month 10.5.|||"percentage of yes response"||95% Confidence Interval|Least Squares Mean
1427979|NCT01026818|Secondary|Change From Baseline in ‘Yes’ Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)|Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEP questions answered at Months 9, 10.5 and 13.5.|||"percentage of yes responses"||95% Confidence Interval|Least Squares Mean
1427980|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 13.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 13.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 13.5.|||participants|||Number
1427981|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 10.5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 10.5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 10.5.|||participants|||Number
1427982|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 9|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 9|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 9.|||participants|||Number
1427983|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 5|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 5|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 5.|||participants|||Number
1427984|NCT01026818|Secondary|Residual Erectile Function (REF) at Month 2|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Month 2|All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 2.|||participants|||Number
1427985|NCT01026818|Secondary|Residual Erectile Function (REF) at Baseline|The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)|Baseline|All randomized participants who received at least 1 dose of study drug and had REF assessed at baseline.|||participants|||Number
1427986|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 13.5|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5.|||participants|||Number
1427987|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 2 at Month 9|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9.|||participants|||Number
1427988|NCT01026818|Secondary|Global Assessment Question (GAQ) Question 1 at Month 13.5|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 13.5|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5.|||participants|||Number
1427997|NCT01026805|Secondary|Adverse Events|Patient medical records were examined to identify any procedure-related or post-treatment adverse events. An adverse event is any undesirable experience (sign, symptom, illness, or other medical event) occurring in a subject, that appears or worsens during a clinical study|2-3 months post-treatment||||events|||Number
1427989|NCT01026818|Secondary|Global Assessment Questions (GAQ) Question 1 at Month 9|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).|Month 9|All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9.|||participants|||Number
1427990|NCT01026818|Secondary|Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score|The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427991|NCT01026818|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score|The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Months 9 and 13.5|All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427992|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)|Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427993|NCT01026818|Secondary|Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|Randomization (Baseline), Months 9 and 10.5 and 13.5|All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5.|||units on a scale||95% Confidence Interval|Least Squares Mean
1427994|NCT01026818|Secondary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 9 and Month 13.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5.|||percentage of participants|||Number
1427995|NCT01026818|Primary|Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire|Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.|Month 10.5|All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5.|||percentage of participants|||Number
1428003|NCT01026792|Primary|Objective Response Rate|Response is defined as a 30% decrease in the sum of the longest diameters of the target lesions (PR) or complete disappearance of disease and symptoms (CR) for at least 4 weeks as assessed by Response Evaluation Criteria in Solid Tumors 1.1|Up to 3 years|Patients evaluable for response|||percentage of patients with response||95% Confidence Interval|Number
1428004|NCT01026493|Secondary|Phase II: Overall Survival (OS)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)|Eligible patients|||months||95% Confidence Interval|Median
1428005|NCT01026493|Secondary|Phase II: Objective Response (Partial and Complete Response) Rate for Patients With Measurable Disease After Surgery|Response and progression will be evaluated using standard criteria for patients with malignant gliomas (Macdonald 1990). Partial response and complete response are centrally reviewed.|Analysis occurs after all patients have been on study for at 6 months. (Patients are followed from randomization to death or study termination whichever occurs first.)|Eligible patients with at least one cycle of treatment|||percentage of participants||95% Confidence Interval|Number
1428006|NCT01026493|Primary|Phase II: 6-month Progression-free Survival (PFS) Rate for Patients With Measurable Disease After Surgery|For patients with measureable disease after surgery: Progression defined as ≥ 25% increase in size of enhancing tumor or any new tumor; or neurologically worse, and steroids stable/increased. Bevacizumab (BEV)-naïve group: p0= 15% as estimate of 6-mo. PFS [null hypothesis (NH)], p1= 30%, with a 15% absolute increase [alternative hypothesis (AH)]. Error rates of 10% alpha and 10% beta. If <= 11 patients experience 6-month PFS of the first 53 analyzable patients, then do not reject the null hypothesis that the 6-month PFS rate of experimental arm is less than 15%; BEV-failure group: p0 = 2% as a conservative estimate of 6-month PFS [NH], p1 = 15%, with a 13% absolute increase [AH]. Using first 26 analyzable subjects for each experimental arm, there is >= 90% power to detect >= 15% increase at a significance level of 0.10, using a 1-sided binomial test. If >= 2 patients (8%) are progression free at 6 mo., then claim this regimen to be promising in the patient group.|Randomization to 6 months.|Randomized patients with measurable disease after surgery, at least one cycle of treatment, evaluable for 6 month PFS, and within the required sample size (i.e. the first 53 BEV-naive patients and the first 26 BEV-failure patients- the number of patients will be less than sample size if not enough patients meet the criteria).|||participants|||Number
1428007|NCT01026493|Primary|Phase 1: Maximum Tolerated Dose (MTD)|Dose limiting toxicity (DLT) = any of the following events within 1st 8 weeks of treatment attributable to study drugs: Any grade (gr) 3/4 thrombocytopenia, gr 4 anemia, gr 3 neutropenia with fever (>100.4). gr 4 neutropenia lasting > 7 days; Any non-hematologic (NH) gr 3+ toxicity (TOX), excluding alopecia, despite maximal medical therapy (MLT); NH TOX such as rash, nausea, vomiting, diarrhea, mucositis, hypophosphatemia, and hypertension will only be considered DLTs if they remain gr 3+ despite MLT; 2nd occurrence of thromboembolism; Failure to recover from TOX (<= gr 1) to be eligible for re-treatment with study drugs <= 14 days of last dose of either drug; Any episode of non-infectious radiologically observed pneumonitis gr 2-4 any duration. Dose level will be considered acceptable if <= 1 of the 1st 6 eligible patients experiences a DLT. If current level is considered acceptable, dose escalation occurs. Otherwise preceding acceptable dose level will be declared the MTD.|Start of treatment to 8 weeks.|Eligible patients who started study treatment|||participants|||Number
1428008|NCT01026454|Secondary|Safety of Valacyclovir 1.5 Gram Orally Twice Daily in HIV-1 Seropositive Persons.||28 weeks|||||||
1428009|NCT01026454|Primary|Mean Level of HIV-1 RNA in Plasma of Participants While on Acyclovir or Valacyclovir.|Mean level of HIV-1 RNA in plasma of participants while on 400 mg twice daily of acyclovir versus while on 1.5 g twice daily of valacyclovir.|Weekly for 12 weeks per intervention||||log10 copies/mL||95% Confidence Interval|Mean
1428010|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 2|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set|||Participants|||Number
1428011|NCT01026402|Secondary|Complete Metabolic Response (CMR), Cycle 1|Complete metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set|||Participants|||Number
1428012|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 2|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 2 Day 8|Efficacy analysis set|||Participants|||Number
1428013|NCT01026402|Secondary|Partial Metabolic Response (PMR), Cycle 1|Partial metabolic responses measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) (or FDG-PET/Computed Tomography (CT)) with a comparison to baseline (pre-dose)|Cycle 1 Day 8|Efficacy analysis set|||Participants|||Number
1428014|NCT01026402|Secondary|Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose|Phosphorylation levels of AKT from PRP (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set|||Percent change||Full Range|Median
1428015|NCT01026402|Secondary|Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose|Phosphorylation levels of 4EBP1 from peripheral blood mononuclear cell (Patients with undetectable values at baseline have been excluded)|predose and 2 hours after a single dose|Efficacy analysis set|||Percent change||Full Range|Median
1428016|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) at Steady State|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set|||L/h||Standard Deviation|Mean
1429726|NCT01012167|Secondary|Laboratory Measures - Albumin|Albumin blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||g/dL||Standard Deviation|Mean
1428017|NCT01026402|Secondary|Urine PK - Renal Clearance (Renal CL) Single Dose|Renal Clearance (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set|||L/h||Standard Deviation|Mean
1428018|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State|Fraction dose excreted unchanged in the urine from 0-12 hours after dosing (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 24 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK|||Percent concentration||Standard Deviation|Mean
1428019|NCT01026402|Secondary|Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose|Fraction dose excreted unchanged in the urine from 0-12 hours after a single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Pre dose through to 12 hours post dose|PK analysis set - A subset of Safety Analysis set who have reportable plasma concentrations and PK parameter data and who have no important protocol deviations/AEs that may impact PK|||Percent concentration||Standard Deviation|Mean
1428020|NCT01026402|Secondary|Area Under the Curve (AUC) at Steady State|AUC at steady state Continuous dosing - AUCss used Intermittent dosing - Weekly AUC used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1428021|NCT01026402|Secondary|Maximum Concentration (Cmax) at Steady State|Cmax at steady state (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Multiple dosing to steady state (up to 12 or 48 hours post dose)|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428022|NCT01026402|Secondary|Area Under the Curve (AUC) Single Dose|Area under the curve following single dose Continuous dosing - AUC parameter used Intermittent dosing - AUC(0-12) used (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1428023|NCT01026402|Secondary|Maximum Concentration (Cmax) Single Dose|Maximum concentration following single dose (n varies between PK outcome measures as a subset of the PK analysis set was used with reportable AZD2014 plasma concentrations and PK parameters at that visit who have no important adverse events or protocol deviations that may impact PK at that visit, which means that different amounts of data were available for different parameters depending on what visits the parameter covered)|Following Single Dose up to 12, 24 or 48 hours post dose|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428024|NCT01026402|Secondary|Best Objective Response|Best Objective Response per Response Evaluation Criteria in Solid Tumours Criteria (RECIST) 1.1 for target and non target lesions assessed by CT, MRI or X-ray; Complete Response (CR), Disappearance of all target lesions since baseline; Partial Response (PR), At least a 30 percent decrease in the sum of diameters of target lesions; Progressive Disease (PD), At least a 20 percent increase in the sum of diameters of target lesions and an absolute increase of at least 5mm|Assessed every 8 weeks until progression or withdrawal, whichever came first, estimated to be up to 4 months|Efficacy analysis set - Patients who received at least 1 dose of AZD2014 and have a baseline tumour assessment|||Participants|||Number
1428025|NCT01026402|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Maximum Tolerated Dose (MTD) was determined by testing various doses and schedules of AZD2014 in cohorts of 3-6 evaluable patients. MTD reflects the highest dose of drug at each schedule that did not cause a DLT in >1 patient|Up to 21 days from first multiple dose|Safety Analysis Set - All patients that received at least 1 dose of AZD2014. This includes dosed patients who are not evaluable for dose escalation decision purposes.|||Participants|||Number
1428026|NCT01026389|Secondary|Sensitivity|sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).|up to one month|Per protocol population|||positive segment with MRA|Participants||Number
1428027|NCT01026389|Secondary|Specificity|Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).|up to one month|per protocol population|||negative segments in MRA|Participants||Number
1428028|NCT01026389|Secondary|Intra-patient Accuracy, in Off-site Readings|• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion|up to one month|"Ecah images from each patient were analysed by two external readers, this means that each patient was analyzed twice.~Per protocol population"|||percentage of agreement|Participants|Standard Deviation|Mean
1428029|NCT01026389|Primary|Intra-patient Accuracy (Percent Agreement), On-site Data|intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.|up to one month|Per protocol population|||percentage of agreement||Standard Deviation|Mean
1428030|NCT01026324|Secondary|Progression-free Survival||Up to 6 months||||participants|||Number
1428031|NCT01026324|Primary|Percentage of Patients Alive (Phase II)|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II|Up to 1 year|Due to difficult accrual to the trial, enrollment was ended early without entering into Phase II||||||
1428032|NCT01026324|Primary|Recommended Phase-2 Dose of SCH727965|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.|14 days|Due to difficult accrual to the trial, enrollment was ended early without determination of an MTD.||||||
1428033|NCT01026220|Secondary|Overall Survival|Survival from enrollment to death.|At 3 years from enrollment|164 Group 1 All Patients received induction therapy. 161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.|||Probability of survival||95% Confidence Interval|Number
1428034|NCT01026220|Secondary|Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy|The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy.|During and after completion of study treatment.|165 eligible patients.|||participants|||Number
1428035|NCT01026220|Secondary|Event Free Survival|Survival from enrollment to first event: relapse/progression, second malignancy, or death.|At 3 years from enrollment|161 patients began consolidation therapy: 81 Group 2 Regimen I and 80 Group 3 Regimen II.|||Probability of survival||95% Confidence Interval|Number
1428036|NCT01026220|Secondary|Relapse-free Survival|A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy.|3 years from enrollment|161 patients began consolidation therapy: 126 patients received risk-adapted radiotherapy after consolidation therapy ABVE-PC and 35 did not.|||Probability of survival||95% Confidence Interval|Number
1428037|NCT01026220|Secondary|Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative|To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.|3 years from enrollment|RER with positive PET-1, Event-Free Survival for RER PET-1 positive patients is compared to that of RER with negative PET-1: n=57 PET-1 positive RER patients, compared to 2 events among n=20 PET-1 negative RER patients. Two PET-1 equivocal RER patients (1 with relapse and 1 censored) are not included in this analysis.|||Probability of survival||95% Confidence Interval|Number
1428038|NCT01026220|Secondary|Second-event-free Survival|Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.|At 4 years from enrollment|This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).|||Probability of survival||95% Confidence Interval|Number
1428039|NCT01026220|Secondary|Event Free Survival|Survival from enrollment to first event: relapse/progression, second malignancy, or death.|At 3 years from enrollment|164 Group 1 All Patients received induction therapy.|||Probability of survival||95% Confidence Interval|Number
1428040|NCT01026220|Primary|Safety Analysis and Monitoring of Toxic Death|The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment.|Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).|The six patients who received induction and reported death. The analysis here examines whether their death is primarily attributable to treatment or not.|||participants|||Number
1428041|NCT01026220|Primary|Second-event-free Survival|Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event.|At 4 years from enrollment|This analysis excludes n=20 patients who had protocol early terminations or deviations (n=4 Regimen I, n=12 Regimen II, and n=4 Induction only).|||Probability of survival||95% Confidence Interval|Number
1428042|NCT01026194|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
1428043|NCT01026194|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*h / dL||Standard Error|Least Squares Mean
1428099|NCT01025453|Secondary|Percentage of Participants With Progression-free Survival Under the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year||||percentage of patients|||Number
1428044|NCT01026194|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
1428045|NCT01026194|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||Percent of HbA1c||Standard Error|Least Squares Mean
1428046|NCT01026181|Primary|Change in BMI|"Patients' weight and height were measured at follow up visit 2 years post operation.~BMI was calculated using the formula: weight (kg)/height(meter)^2"|from baseline to 2-year postoperation||||kg/m^2||Standard Deviation|Mean
1428047|NCT01026181|Primary|Change in Body Weight|Change of body weight in Kilograms measured at follow-up visits two year after surgery|baseline to 2-year postoperation||||kg||Standard Deviation|Mean
1428048|NCT01026142|Secondary|Duration of Objective Response|Duration of Objective Response was defined for the subpopulation of responders as time from first Independent Review Facility (IRF)-assessed complete response (CR) or partial response (PR) to subsequent first documented, IRF-confirmed evidence of disease progression. Only participants with an objective response were included in the analysis of duration of objective response.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).||||Weeks||95% Confidence Interval|Median
1428049|NCT01026142|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate is based upon Independent Review Facility (IRF) assessments; defined as the percentage of participants a complete response (CR), partial response (PR), or stable disease for at least 8 cycles or 6 months.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1428050|NCT01026142|Secondary|Overall Objective Response Rate (ORR)|Overall Objective Response Rate is based upon investigator and IRF assessments. Objective Response Rate (ORR) was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) among those who had measurable disease at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|Participants without a post-baseline tumor assessment were considered to be non-responders and were not included in this outcome measure.|||Percentage of participants|||Number
1428051|NCT01026142|Secondary|Time to Treatment Failure (TTF) Based Upon Independent Review Facility (IRF) Assessment|Time to Treatment Failure (TTF) was defined as time between randomization and date of disease progression based on independent review, death, or withdrawal of treatment due to adverse events, withdrawn informed consent, refusal of treatment/failure to cooperate, or failure to return, whichever occurred first.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.|||Weeks||95% Confidence Interval|Median
1428052|NCT01026142|Secondary|Time to Progression (TTP) Based Upon Independent Review Facility (IRF) Assessment|Time to Progression (TTP) was defined as time between randomization and the first occurrence of progressive disease (PD), based on IRF assessment.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.|||Weeks||95% Confidence Interval|Median
1428053|NCT01026142|Secondary|Investigator Assessment Progression-Free Survival (PFS)|Investigator Assessment Progression-Free Survival (PFS) was defined as the time from randomization to the first documented progressive disease, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.0, or death from any cause, whichever occurred first. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 7.5 years).|All randomized participants.|||Months||95% Confidence Interval|Median
1428054|NCT01026142|Secondary|Overall Survival (OS) Rate Based on a 2-year Truncated Analysis|The Overall Survival (OS) 2-year truncated analysis is the Kaplan-Meier estimate of the percentage of participants who were surviving at 2 years. OS is defined as the time from the date of randomization to the date of death from any cause, with censoring of all events and follow-up beyond the end of the second year.|From randomization until death from any cause (up to 2 years)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
1428100|NCT01025453|Secondary|Duration of Study Treatment for Participants With and Without BRAF Mutations||6 years|The analysis separated the participants into 2 groups (number of patients with BRAF V600E Mutation and number of patients without BRAF V600E Mutation)|||months||Full Range|Median
1441283|NCT00926211|Secondary|Proportion of Harvested Follicles Transected|The proportion of harvested hair follicles that were transected by each harvest method.|Time of harvest (Baseline)||||Proportion of transected follicles||Standard Deviation|Mean
1428055|NCT01026142|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from the date of randomization to the date of death from any cause. The results of the final OS analysis are presented here. Participants who were alive or lost to follow-up at the time of the analysis were censored at the last known alive date. Participants with no postbaseline information were censored at the time of randomization plus 1 day. Prior to the final data analysis cut-off, it was ensured that all participants who were in survival follow-up had been contacted as recently as possible within the last 3 months to confirm current survival status.|From randomization until death from any cause (up to 7.5 years).|All randomized participants.|||Months||95% Confidence Interval|Median
1428056|NCT01026142|Primary|Progression Free Survival (Independent Assessment)|Progression Free Survival (PFS) was defined as the time from randomization to first documented disease progression (PD), as determined by an Independent Review Facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. IRF review of tumor assessment ceased after the primary PFS analysis. The primary endpoint was analyzed after approximately 337 IRF-assessed PFS events were observed.|Tumor assessments every 9 weeks from randomization until Week 27, then every 12 weeks thereafter, until IRF-determined PD, initiation of alternative anticancer medication, or death (up to 5.5 years).|All randomized participants.|||months||95% Confidence Interval|Median
1428057|NCT01026103|Secondary|Incidence of Serosal Tearing||30 days post op||||participants|||Number
1428058|NCT01026103|Secondary|Length of Hospital Stay||Date of discharge which averages 3 days||||days||Standard Deviation|Mean
1428059|NCT01026103|Secondary|Incidence of Intra-operative Bleeding Requiring Intervention||Day 0 and 1 month||||participants|||Number
1428060|NCT01026103|Primary|Proportion of Patients With an Uneventful Creation of a Functional Staple Line||Day 0||||participants|||Number
1428061|NCT01026038|Post-Hoc|Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1428062|NCT01026038|Secondary|Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.|||Percentage of Participants||95% Confidence Interval|Number
1428063|NCT01026038|Secondary|Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine|Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.|One month after vaccination|The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.|||Percentage of Participants||95% Confidence Interval|Number
1428064|NCT01026038|Secondary|Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine|Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|One month after vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1428065|NCT01026038|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine|Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Up to 7 days before vaccination|Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.|||Geometric mean titers||95% Confidence Interval|Geometric Mean
1428066|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Four to seven days after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1428242|NCT01023958|Secondary|Duration of Disease Control|Disease control is defined as having a best overall response of CR, PR, or SD. The duration of disease control is measured from the time of first response to progression or death whichever occurs first.|Time of first response to progression or death, up to 2 years|Patients who achieved disease control in the TS.|||Weeks||Full Range|Median
1428067|NCT01026038|Secondary|Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine|IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Up to 7 days before vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1428068|NCT01026038|Primary|Percentage of Participants With Prespecified Systemic Events|Systemic events (any fever >= 38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to <=39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."|||Percentage of Participants|||Number
1428069|NCT01026038|Primary|Percentage of Participants With Prespecified Local Reactions|Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (>7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.|Seven days after vaccination|"Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively."|||Percentage of Participants|||Number
1428070|NCT01026038|Primary|Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine|Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.|One month after vaccination|Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1428071|NCT01026012|Primary|Number of Participants With Side Effects, Including Dyspnea, Headache, Dizziness, Chest Pain, Nausea, Abdominal Discomfort, Dysgeusia, Flushing, and Symptomatic Hypotension and Others.|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.( 1-2 hours total: for the during the subject was in the office for the test)|During and 30 minutes after stress test|Subjects whom completed the combined stress test, including imaging|||participants|||Number
1428072|NCT01025843|Secondary|Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.|||µmol/L||Standard Deviation|Mean
1428073|NCT01025843|Secondary|Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan|Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.|Baseline and 1 to 3 hours postdose|Results were not analyzed because none showed a > 5% decrease in AIx.||||||
1428074|NCT01025843|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan|Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan|Pre-dose and up to 48 hours postdose|In order to keep the study blinded, the scheduled number of treated participants rather than the actual number of treated participants were analyzed; according to the scheduled study drug and not by randomly assigned sequence.|||umol.hr/L||Standard Deviation|Mean
1428075|NCT01025843|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Up to 24 hours after administration of study drug|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.|||Participants|||Number
1428146|NCT01025193|Secondary|B and T Lymphocyte Subsets|B and T Lymphocyte subsets were measured through flow cytometry pre-treatment and at months 1,2,12 and at 8 weeks after the last belimumab dose. We looked for clinically significant changes (as determined by Principal Investigator) in these subsets at each time-point.|8 weeks after the last dose of belimumab|Any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
1428076|NCT01025843|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Up to 14 days after administration of last dose of study drug (up to Day 52)|All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.|||Participants|||Number
1428077|NCT01025830|Secondary|Maximum Plasma Concentration of Drug|Maximum concentration of drug in plasma that was attained post dosing|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Intention to treat analysis used including only participants with sufficient plasma samples for analysis. Separate analyses are given for each drug. Results for this kind of study are not combined.|||milligram/liter||Standard Deviation|Geometric Mean
1428078|NCT01025830|Primary|Area Under the Concentration-Time Curve(AUC)|Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed|Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing|Analyzed population consists only of participants who had sufficient plasma samples for analysis.Intent to treat analysis was used. Separate analyses provided for each drug. Results of such a study are not combined.|||hour*milligram/liter||Standard Deviation|Geometric Mean
1428079|NCT01025817|Secondary|Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events|Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS|||Participants|Participants||Number
1428080|NCT01025817|Secondary|Number of Participants With Incidence of Proteinuria Events|Number of participants with Incidence of proteinuria events indicating chronic kidney disease|Baseline and 12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS|||Participants|Participants||Number
1428081|NCT01025817|Secondary|Number of Participants With Incidence of New Onset of Diabetes Mellitus|Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant, or with a random plasma glucose ≥200 mg dL (11.1 mmol/L) with 2 fasting plasma glucose values ≥126 mg/dL (7 mmol/L)|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.|||Participants|Participants||Number
1428082|NCT01025817|Secondary|Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy|Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS|||Participants|Participants||Number
1428083|NCT01025817|Secondary|Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)|Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus.|12 Months|Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.|||Participants|Participants||Number
1428084|NCT01025817|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1|12 Months|Full Analysis Set (FAS) consisted of all patients randomized after transplantation|||mL/min/1.73m˄2||Standard Deviation|Mean
1428085|NCT01025817|Primary|Number of Participants With Incidence of Composite Efficacy Failure|Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, (3) participant death or(4) loss to follow-up. *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.|12 Months|Full Analysis Set (FAS) consisted of all participants randomized after transplantation|||Participants|Participants||Number
1428086|NCT01025752|Secondary|Change in Pittsburgh Sleep Quality Index|The PSQI assess sleep quality, with lower scores indicating better sleep, range 0 to 21.We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
1428087|NCT01025752|Secondary|Change in Beck Depression Inventory-II|Depressive symptom severity was assessed using the BDI-II, higher scores indicate more depressive symptomology, range 0-63. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
1428159|NCT01024972|Secondary|In-hospital Mortality|Number of subjects who expired during hospitalization.|up to 90 days||||participants|||Number
1428088|NCT01025752|Secondary|Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale|The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
1428089|NCT01025752|Secondary|Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale|The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
1428090|NCT01025752|Secondary|Change in Roland Morris Disability Questionnaire|The RMDQ (Roland & Morris, 1983) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
1428091|NCT01025752|Secondary|Change in Multidimensional Pain Inventory Interference Subscale|The interference subscale of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) assesses pain-related interference with quality of life. Scores ranging from 0-6, with higher scores indicating more interference. We computed the change from baseline.|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
1428092|NCT01025752|Primary|Change in Numeric Rating Scale of Pain Intensity|"An 11-point NRS for pain was administered to patients, with 0 representing No Pain and 10 representing Worst Possible Pain. Patients were asked to rate the level of pain that best represented their experience of worst pain, least pain and average pain over the past week. We computed the change from baseline."|post-treatment (12 weeks), 3 and 6 months post-baseline|The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).|||units on a scale||95% Confidence Interval|Least Squares Mean
1428093|NCT01025635|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as ‘responder’. Subjects with an IGA of moderate or severe at the end of treatment were considered as ‘non-responder’. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as ‘non-responders’.|At End of treatment (up to 12 weeks) (LOCF)||||Percentage of participants|||Number
1428094|NCT01025635|Secondary|Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||At End of treatment (up to 12 weeks) (LOCF)||||Percentage of Inflammatory lesions||Standard Deviation|Mean
1428095|NCT01025635|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)||Baseline and End of treatment (up to 12 weeks) (LOCF)||||Inflammatory lesions||Standard Deviation|Mean
1428096|NCT01025635|Primary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At End of treatment (up to 12 weeks) (LOCF)||||Percentage of participants|||Number
1428097|NCT01025492|Primary|Apolipoprotein A-I Serum Concentration|Comparison of apolipoprotein A-I concentrations after 12 weeks of treatment with either Trilipix or placebo|12 weeks|The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled. Additionally, the study outcome measure/endpoint (Apolipoprotein A-I serum concentration) was not analyzed.||||||
1428098|NCT01025453|Secondary|Safety and Tolerability for the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.|Participant toxicities evaluated by CTCAE version 4.0|3 years||||Participants|||Count of Participants
1428160|NCT01024972|Secondary|Liver Toxicity|Number of subjects who developed liver toxicity as evidenced by Liver Function Test elevation greater than 5 times the upper limit of normal.|7 days||||participants|||Number
1428101|NCT01025453|Primary|Reponse Rate of the Combination Sorafenib and Temsirolimus in I-131 Refractory Thyroid Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years|7 participants were not evaluable because they came off treatment before the first radiographic scan for reasons other than progression of disease, including but not limited to excessive toxicity (n=1), withdrawal of consent (n=3), and seeing other treatment (n=1).|||Participants|||Count of Participants
1428102|NCT01025336|Primary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 in Parent Study 6115A1-3005 (NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
1428103|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428104|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC 1 Year After Vaccination 1 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428105|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428106|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Baseline; Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428107|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC/13vPnC Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428108|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 23vPS/13vPnC 1 Year After Vaccination 2 Compared to 13vPnC 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428109|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence for 13vPnC/23vPS 1 Year After Vaccination 2 Compared to 23vPS 1 Year After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428110|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428161|NCT01024972|Primary|Hyponatremia|Number of subjects who developed hyponatremia (sNa ≤132mmol/L)|Seven days||||participants|||Number
1428111|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 13vPnC/23vPS (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428112|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/13vPnC Compared to 23vPS/13vPnC (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428113|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 for 13vPnC/23vPS Compared to 23vPS/13vPnC (Parent Study 6115A-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||titer||95% Confidence Interval|Geometric Mean
1428114|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428115|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428116|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428117|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 1 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 0 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428118|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00546572), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population. N=number of participants with valid and determinate assay results for the specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428119|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to Before Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 0/Year 1 (Parent Study NCT00574548), Month 1/Year 2 (Follow-up Study NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428162|NCT01024959|Primary|Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.)|The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score >=25 was positive, PCA3 Score <25 was negative|At the time of biopsy|A total of n=466 subjects have valid and reportable PCA3 Scores and disease status (determined by biopsy result), and who were 50 years of age or older.|||participants|||Number
1444034|NCT00904371|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||mm Hg||Standard Deviation|Mean
1428120|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3005; NCT00546572)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00546572), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428121|NCT01025336|Secondary|Serotype-Specific Pneumococcal OPA GMT Antibody Persistence 1 Year After Vaccination 2 Relative to 1 Month After Vaccination 2 (Parent Study 6115A1-3010; NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). CI for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Month 1/Year 1 (Parent study/NCT00574548), Month 1/Year 2 (Follow-up Study/NCT01025336)|All-Available Immunogenicity Population; N=number of participants with valid and determinate assay result for specified serotype at both 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|||titer||95% Confidence Interval|Geometric Mean
1428122|NCT01025336|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Antibody Persistence 1 Year After Vaccination (Vax) 2 in Parent Study 6115A1-3010 (NCT00574548)|Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CIs) for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.|Month 1/Year 2 (Baseline) (Follow-up Study 6115A1-3018; NCT01025336)|All-Available Immunogenicity Population included all participants enrolled in 6115A1-3018 (NCT01025336) with a valid and determinate assay result who received both vaccinations in either parent study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572). N=number of participants with valid and determinate antibody titer for the specified serotype.|||titer||95% Confidence Interval|Geometric Mean
1428123|NCT01025284|Secondary|Total Lung Cancer Symptom Scale (LCSS) and Average Symptom Burden Index (ASBI)|LCSS is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. The LCSS total score was defined as the mean of the 9 items of the scale, with scores range from 0 (for best outcome) to 100 (for worst outcome). ASBI was calculated as the mean of six symptom-specific questions from the LCSS, with scores range from 0 (for best outcome) to 100 (for worst outcome).|Baseline and follow-up up to 104 weeks after the first dose of study drug|All participants who received at least 1 dose of study drug and had total LCSS and ASBI scores at baseline and follow-up in Part B.|||units on a scale||Standard Deviation|Mean
1428124|NCT01025284|Secondary|Part B: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]||Day 3 of Cycle 1 (21-day cycle)|All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had pharmacokinetic samples collected on Day 3 of Cycle 1 in Part B that enabled calculation of the AUC(0-∞).|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1428125|NCT01025284|Secondary|Part A: Pharmacokinetics - Area Under the Plasma Concentration Versus Time Curve of LY2523355 From Time Zero to Infinity [AUC(0-∞)]|Due to the very limited pharmacokinetic sampling employed in Part A of the study, the AUC(0-∞) of LY2523355 could not be accurately calculated.|Days 1,5 and 9 of Cycle 1 (21-day cycle)|No participants were analyzed due to the very limited pharmacokinetic sampling employed in Part A that did not allow accurate calculation of the AUC(0-∞) on Days 1, 5, and 9 of Cycle 1.||||||
1428126|NCT01025284|Secondary|Part B: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355||Day 3 of Cycle 1 (21-day cycle)|All participants who received 1 dose of study drug on Days 1, 2, and 3 of Cycle 1 and had Cmax samples collected on Day 3 of Cycle 1 in Part B.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1428127|NCT01025284|Secondary|Part A: Pharmacokinetics - Maximum Observed Plasma Concentration (Cmax) of LY2523355 and Its Metabolite (LSN2546307)||Days 1,5 and 9 of Cycle 1 (21-day cycle)|All participants who received 1 dose of study drug on Days 1, 5, and 9 of Cycle 1 and had Cmax samples collected on Days 1, 5, and 9 of Cycle 1 in Part A.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1428128|NCT01025284|Secondary|Part B: Percentage of Participants Achieving an Overall Response (Overall Response Rate)|The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease up to 18.1 weeks|All participants who received at least 1 dose of study drug in Part B.|||percentage of participants||90% Confidence Interval|Number
1428129|NCT01025284|Secondary|Part A: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)|Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease 99.6 weeks|All participants who received at least 1 dose of study drug in Part A.|||percentage of participants||90% Confidence Interval|Number
1428243|NCT01023958|Secondary|Disease Control Rate|Disease control rate. Disease control is defined as having a best overall response of complete response (CR), partial response (PR) or stable disease (SD).|From first drug administration until end of study, up to 2 years|TS|||Percentage of participants||95% Confidence Interval|Number
1428130|NCT01025284|Secondary|Part B: Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.|Date of enrollment to date of measured progressive disease or date of death from any cause up to 18.1 weeks|All participants who received at least 1 dose of study drug in Part B. The numbers of participants censored are 4.|||weeks||90% Confidence Interval|Median
1428131|NCT01025284|Secondary|Part A: Progression-Free Survival|Progression-free survival (PFS) is defined as the time from the date of enrollment (first treatment dose) to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is a ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death or starting new anti-cancer therapy, PFS was censored at their last radiological tumor assessment.|Date of enrollment to date of measured progressive disease or date of death from any cause up to 99.6 weeks|All participants who received at least 1 dose of study drug in Part A. The numbers of participants censored are 4.|||weeks||90% Confidence Interval|Median
1428132|NCT01025284|Primary|Part B: Percentage of Participants Achieving a Best Response (Clinical Benefit Rate)|Clinical benefit rate is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Clinical benefit rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease up to 18.1 weeks|All participants who received at least 1 dose of study drug in Part B.|||percentage of participants||90% Confidence Interval|Number
1428133|NCT01025284|Primary|Part A: Percentage of Participants Achieving an Overall Response (Overall Response Rate)|The overall response is complete response (CR) + partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions. The overall response rate is calculated as a total number of participants with CR or PR, then divided by the total number of participants treated, then multiplied by 100.|Date of enrollment to date of measured progressive disease up to 99.6 weeks|All participants who received at least 1 dose of study drug in Part A.|||percentage of participants||90% Confidence Interval|Number
1428134|NCT01025271|Secondary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) to Determine the CSF Penetration and Pharmacokinetic Parameters in This Patient Population (|no analysis completed|5 years|||||||
1428135|NCT01025271|Primary|Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis|unable to meet enrollment no data available. Study terminated early|5 years|unable to meet enrollment no data available. Study terminated early||||||
1428136|NCT01025232|Secondary|Evaluate the Relationship Between Specific Genetic Polymorphisms Associated With AMD, Disease Characteristics and Processes, and Response to Intravitreal Ranibizumab||1 year|Given lack of clinical benefit of 2.0 mg ranibizumab, as demonstrated in the HARBOR trial [Busbee BG, et al. (2013) Ophthalmology 120(5), 1046-1056], further secondary analyses were suspended.||||||
1428137|NCT01025232|Secondary|Assess Number of Ranibizumab Injections in Each of the Two Doses Required Through Month 12||1 year||||number of injection||Standard Deviation|Mean
1428138|NCT01025232|Secondary|Evaluate Mean Change in Central Retinal Thickness Over Time Through Month12 as Assessed by All Three OCTs (Stratus, Cirrus, and Spectralis)||1 year||||micrometer||Standard Deviation|Mean
1428139|NCT01025232|Secondary|Determine Number of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12 in ETDRS BCVA.||1 year||||participants|||Number
1428140|NCT01025232|Secondary|Determine Number of Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12 and Month 12 in ETDRS BCVA||1 year||||participants|||Number
1428141|NCT01025232|Secondary|Evaluate the Incidence and Severity of Ocular and Non-ocular Adverse Events (AEs) Through Month 12||1 year||||Incidents|||Number
1428142|NCT01025232|Primary|Mean Change From Baseline in ETDRS BCVA at Month 12 (Fixed Interval Dosing Primary Endpoint After 3 Monthly Doses. Variable Interval Dosing Primary Endpoint at 1 Year.)|Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) was used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|1 Year||||ETDRS BCVA Letters||Standard Error|Mean
1428143|NCT01025193|Secondary|Number of Participants With Treatment Related Serious Adverse Events|To assess the safety of belimumab in sensitized patients awaiting kidney transplant we evaluated the number of participants with serious adverse events possibly or definitely related to belimumab.|up to one year pre-transplant|Any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
1428144|NCT01025193|Secondary|Hepatitis B Vaccine Antibody Titers|We investigated if belimumab treatment would decrease Hepatitis B vaccine titers by 12 months after treatment with belimumab. All patients received Hepatitis B vaccine before beginning treatment with belimumab.|up to 12 months of treatment with belimumab|All patients who received at least one dose of belimumab were included in the analysis|||Participants|||Count of Participants
1428145|NCT01025193|Secondary|BLyS Levels Before and After Treatment With Belimumab|We assessed for unexpected changes in bound and unbound BLyS levels before and after treatment with belimumab. These were measured from before treatment and at months 1,2,6,10 and 12 months after belimumab treatment and again at 8 weeks after belimumab treatment.|up to 8 weeks after completion of therapy|Any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
1428147|NCT01025193|Secondary|Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point.|We wanted to look at belimumab pharmacokinetics in sensitized patients awaiting kidney transplant. These are reported as number of participants with specific dilution factors at each studied time-point. Blood for these tests could be drawn pre dose as well as 0-4 hours after the dose was given. Belimumab dilutions factors were measured pre dose at timepoints 0 (first day of belimumab), days 56 and 364. Belimumab dilution factors were measured after the dose on days 14, and 168. Belimumab dilution factors were also measured at 8 weeks after completion of belimumab therapy and pre dose at any unscheduled visits if needed.|Belimumab serum drug dilution factors were measured in patients at at timepoints 0 (first day of belimumab), day 14, day 56, day 168, 364, at any unscheduled visits, and at 8 weeks post completion of belimumab therapy.|any patient who received at least one dose of belimumab was included in the analysis|||Participants|||Count of Participants
1428148|NCT01025193|Primary|Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy)|In order for a sensitized recipient ( a recipient with antibodies) to be transplanted, the cross match with the donor has to be compatible. We wanted to study if belimumab reduced antibodies in sensitized patients and led those patients to subsequently become cross-match compatible with a donor and allow for successful transplant.|one year pre-transplant|All participants enrolled who received at least one dose of belimumab were considered for analysis.|||Participants|||Count of Participants
1428149|NCT01025193|Primary|Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation.|Before transplant it is necessary to measure antibodies that the recipient might have and compare them to the living or decease donor's immune make-up. Recipients with many antibodies or a specific antibody in a high concentration may have a more difficult time finding a compatible donor, and being transplanted. These recipients are referred to as sensitized patients. It is important that the sensitized recipient and the donor be compatible to prevent rejection after transplant. We measured antibodies levels in sensitized patients waiting for kidney transplant, to see if belimumab would decrease these antibody levels.|up to one year pre-transplant|any patient who received at least one dose of belimumab was included in analysis population|||Participants|||Count of Participants
1428150|NCT01025154|Primary|Median Event-Free Survival (EFS)|Event-free survival (EFS) defined as time from start of treatment to first documentation of disease relapse or death.|2 years|Two of the fifty-nine participants were not included in the analysis.|||Months||Full Range|Median
1428151|NCT01025154|Primary|Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery|Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L. Response evaluated within 8 weeks after induction therapy.|8 weeks after Induction therapy (induction cycle 4-6 weeks)|Two of the fifty-nine participants were not evaluable.|||participants|||Number
1428152|NCT01025076|Primary|Primary Outcome: Change in Body Weight|Body weight changes at 6 months after StomaphyX procedure comparing to baseline weight.|At 6 months comparing to baseline weight||||kg||Standard Deviation|Mean
1428153|NCT01025037|Secondary|Isometric Strength||baseline, post-op months 6, 12, and 24||||newtons (N)||Standard Deviation|Mean
1428154|NCT01025037|Primary|Simple Shoulder Test (SST)|"The Simple Shoulder Test (SST): a series of 12 yes or no questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure & Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome."|baseline, post-op months 3, 6, 12, and 24||||units on a scale||Standard Deviation|Mean
1428155|NCT01025037|Primary|Adjusted Constant-Murley Score|The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living – sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller & Uhl, 2005).|baseline, post-op months 6, 12, and 24||||units on a scale||Standard Deviation|Mean
1428156|NCT01025037|Other Pre-specified|Incidence of Complications, Including Infection|Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert.|All time points||||percentage of participants|||Number
1428157|NCT01025037|Secondary|Rotator Cuff Re-tear Evaluation|"Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported.~Two different definitions of a re-tear were used for the analysis.~Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.~Sub-analysis: Full thickness tear one centimeter or greater in length."|Post-op months 6 and 12|Participants were analyzed at 6 and 12 months post-op. 2 participants not analyzed due to exclusion prior to 6 month post op visit.|||percentage of participants|||Number
1428158|NCT01025037|Primary|American Shoulder and Elbow Score (ASES)|The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, & Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.|baseline, post-op months 3, 6, 12, and 24||||units on a scale||Standard Deviation|Mean
1428163|NCT01024946|Primary|To Determine the Rate of Clinical Benefit (i.e. Rate of Complete or Partial Response Plus Stable Disease) at 16 Weeks for Patients With Malignant Mesothelioma Treated With Everolimus as Second or Third Line Therapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|16 weeks||||participants|||Number
1428164|NCT01024855|Primary|Number of Eyes With No Change in Corneal Staining|Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.|Change from baseline after 1, 2, 4 and 6+ hours of wear|per protocol|||eyes|||Number
1428165|NCT01024751|Secondary|Slit Lamp Findings|Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.|Over all visits for 1 month|Greater than grade 2 for all dispensed eyes with non-missing scores|||eyes|Participants||Number
1428166|NCT01024751|Primary|Comfort-related Symptoms/Complaints|Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.|At dispensing visit and each follow-up visit at week 2 and week 4.|Summaries included all eligible, dispensed participants, with participants summarized under the study products received.|||Units on a scale|Participants|Standard Deviation|Mean
1428167|NCT01024738|Primary|Plaque Index|Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 Days||||Units on a scale||Standard Deviation|Mean
1428168|NCT01024608|Secondary|Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period|"Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities).~The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1428169|NCT01024608|Secondary|Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of ‘emotional’ utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.|Day 0 (Baseline), Day 15|The RQLQ population, subset of ITT population, included only those participants over the age of 18 years (fluent in English) with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
1428170|NCT01024608|Secondary|Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The iTNSS (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1428171|NCT01024608|Primary|Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping).~The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement."|Baseline (Days -3 to 0), and Days 1-15|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1428172|NCT01024465|Primary|Total Weight Loss|Mean weight loss in kilograms compared with the baseline value through 6 months of study follow up.|baseline to 180 days|Subjects with a weight recorded at 6 months|||kg||Standard Deviation|Mean
1428173|NCT01024387|Secondary|1-Year Overall Survival|Overall survival (OS) based on the Kaplan-Meier method is defined as the time from treatment start to the date of death or censored at the date last known alive. 1-year overall survival is the probability (%) of remaining alive 1 year from the start of treatment.|Patients in this study cohort were followed up to 20 months.|The analysis dataset is comprised of all enrolled patients.|||percent probability||95% Confidence Interval|Number
1428212|NCT01024036|Secondary|Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline|SF-36 is a questionnaire and PCS is a part of subscale assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life.|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
1428174|NCT01024387|Secondary|Progression Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from the start of treatment to the date of the first documented disease progression or death due to any cause. Patients without an event were censored at the earliest date of last disease assessment or initiation of non-protocol anti-cancer therapy. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort were followed up to 20 months.|The analysis dataset is comprised of all PFS evaluable patients.|||months||95% Confidence Interval|Median
1428175|NCT01024387|Secondary|Grade 3-4 Toxicity Rate|Grade 3-4 toxicity rate is the percentage of patients who experienced a grade 3 or 4 adverse event with treatment attribution of possible, probable or definite based on CTCAEv4.|Toxicity was evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).|The analysis dataset is comprised of all enrolled patients.|||percentage of patients||95% Confidence Interval|Number
1428176|NCT01024387|Secondary|Duration of Response|The duration of response is measured from the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).|This endpoint was not evaluated because zero patients achieved objected response per RECIST criteria.||||||
1428177|NCT01024387|Primary|Objective Response Rate|Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks).|The analysis dataset is comprised of all response evaluable patients.|||percentage of patients|||Number
1428178|NCT01024335|Primary|Retention|Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.|retention over 8 weeks.||||participants|||Number
1428179|NCT01024335|Primary|Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .|The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.|3x/week during 8 weeks of the trial or study participation||||units on a scale||Standard Deviation|Mean
1428180|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.|||units on a scale||Inter-Quartile Range|Median
1428181|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|12 month|A total of 37 participants returned for follow-up at 12 months. The remaining patients did not return to the clinic for follow-up at 12 months.|||units on a scale||Inter-Quartile Range|Median
1428192|NCT01024244|Secondary|30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall|Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes per 30 days|||Number
1428239|NCT01023958|Secondary|t1/2 of Volasertib|Terminal half-life (t1/2) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||hours||Geometric Coefficient of Variation|Geometric Mean
1428182|NCT01024309|Secondary|WOMAC|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|6 week|A total of 54 participants returned for follow-up at 6 weeks. 3 participants did not complete the WOMAC in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||units on a scale||Inter-Quartile Range|Median
1428183|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|6 week|54 participants returned for follow-up at 6 weeks. A total of 5 participants did not complete the Harris Hip Score instrument in its entirety at this appointment and, thus, were excluded from the analysis. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||units on a scale||Inter-Quartile Range|Median
1428184|NCT01024309|Secondary|Anteversion Angle|Anteversion angle is a radiographic measure of implant position. 35 degrees of anteversion is optimal. 25-45 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 35 degrees indicate better placement.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||degrees||Inter-Quartile Range|Median
1428185|NCT01024309|Secondary|Abduction Angle|Abduction angle is a radiographic measure of implant position. 40 degrees of abduction is optimal. 30-50 degrees of anteversion indicates correct placement of prosthetic joint. Values closer to 40 degrees indicate better placement.|6 wk|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||degrees||Inter-Quartile Range|Median
1428186|NCT01024309|Secondary|Western Ontario and McMaster Universities Arthritis Index (WOMAC)|Total score from the Western Ontario and McMaster Universities Arthritis Index (WOMAC), which is a widely used set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. WOMAC measures five items for pain (score range 0–20), two for stiffness (range 0–8), and 17 for functional limitation (range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in/out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties. It produces three subscale scores (pain, stiffness, and physical function) and a total score. These scores are transformed into a scale of 0 (worst possible outcome) to 100 (best possible outcome) for ease of interpretation and comparison with other studies.|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.|||units on a scale||Inter-Quartile Range|Median
1428187|NCT01024309|Secondary|Harris Hip Score|The postoperative rate of improvement in functional outcome, measured by the Harris Hip Score (HHS). The HHS was developed to assess the results of hip surgery and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items, which are summed to create a score out of 100. The score has a range of 0 (wost possible outcome) to 100 (best possible outcome) covering pain (0–44 points), function (0–47 points), absence of deformity (4 points), and range of motion (5 points).|3 week|A total of 53 participants returned for follow-up at 3 weeks. The remaining patients did not return to the clinic for follow-up at 3 weeks.|||units on a scale||Inter-Quartile Range|Median
1428188|NCT01024309|Primary|Number of Days for Discontinue Assistive Devices|The primary early functional endpoint is the difference between groups in the postoperative days that patients require any assistive devices for ambulation. Lower number of days indicate better outcomes.|6 week|A total of 54 participants returned for follow-up at 6 weeks. The remaining patients did not return to the clinic for follow-up at 6 weeks.|||days||Inter-Quartile Range|Median
1428189|NCT01024296|Primary|Time of Port Site Closure||Day 1, from insertion to removal of Port Close device during surgery|Participants with successful closure using the Port Close device were included in the analysis.|||seconds||Standard Deviation|Mean
1428190|NCT01024296|Primary|Count of Participants With Successful Port Site Closure Using Port Close Device||Day 1, at the end of surgery||||Participants|||Count of Participants
1428191|NCT01024244|Secondary|Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks|Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||beats per minute (bpm)||Standard Deviation|Mean
1428193|NCT01024244|Secondary|Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506|The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.|||nanograms per milliliter times hour||Standard Deviation|Mean
1428194|NCT01024244|Secondary|Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506|The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12|Data were reviewed but are not presented due to the insufficient sample size and the sparse sampling approach.|||nanograms per deciliter (ng/dL)||Standard Deviation|Mean
1428195|NCT01024244|Secondary|Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period|The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|No participants had data analyzed due to insufficient sample size.|||milligrams (mg)||Standard Deviation|Mean
1428196|NCT01024244|Secondary|Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks|Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428197|NCT01024244|Secondary|Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks|Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428198|NCT01024244|Secondary|Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks|DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428199|NCT01024244|Secondary|Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period|Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.|Baseline through 12 weeks, Baseline through 16 weeks|Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.|||percentage of participants|||Number
1428200|NCT01024244|Secondary|Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period|Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
1428201|NCT01024244|Secondary|Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period|Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of participants|||Number
1428202|NCT01024244|Secondary|Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 4 weeks, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1428203|NCT01024244|Secondary|Change From Baseline in Body Weight at 12 Weeks and 16 Weeks|Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||kilograms (kg)||Standard Deviation|Mean
1428204|NCT01024244|Secondary|Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period|Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline through 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||hypoglycemic episodes|||Number
1428205|NCT01024244|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks|Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but are not presented due to insufficient sample size.|||mm Hg||Standard Deviation|Mean
1428206|NCT01024244|Secondary|Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks|Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|Quality of life data were not analyzed due to insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428207|NCT01024244|Secondary|Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks|Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks, 16 weeks|Data were reviewed but not presented due to insufficient sample size.|||millimoles per liter (mmoL/L)||Standard Deviation|Mean
1428208|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%S) was not calculated due to insufficient sample size.|||percentage of insulin sensitivity (%S)||Standard Deviation|Mean
1428209|NCT01024244|Secondary|Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks|HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.|Baseline, 12 weeks, 16 weeks|HOMA2 (%B) was not calculated due to insufficient sample size.|||percentage of beta cell function (%B)||Standard Deviation|Mean
1428210|NCT01024244|Secondary|Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks|Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 16 weeks|The QT interval was not analyzed due to insufficient sample size.|||milliseconds (ms)||Standard Deviation|Mean
1428211|NCT01024244|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.|Baseline, 12 weeks|Data were reviewed but are not presented due to insufficient sample size.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1428213|NCT01024036|Secondary|Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline|The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from “not at all” (0) to “very much” (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes.|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
1428214|NCT01024036|Secondary|Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman’s Disease Symptom Scale (MCD-SS) Score From Baseline|A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe).|From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||Full Range|Median
1428215|NCT01024036|Secondary|6-year Survival Rate|Overall survival was defined as percent chance of survival of participants who were still alive at 6 years from time of first study treatment was analyzed.|until 6 years|Safety Analysis set included all randomized participants who received at least 1 dose of study agent.|||Percent chance of survival||95% Confidence Interval|Median
1428216|NCT01024036|Secondary|Percentage of Participants Who Discontinued Corticosteroids|Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1).|From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years)|All randomized participants who were dependent on corticosteroids at baseline.|||Percentage of participants|||Number
1428217|NCT01024036|Secondary|Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)|Hemoglobin response rate is defined as percentage of participants who achieved >= 20 g/L hemoglobin at Week 13.|Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 post-baseline hemoglobin evaluation.|||Percentage of participants|||Number
1428218|NCT01024036|Secondary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)|Hemoglobin response rate is defined as percentage of participants who achieved >= 15 g/L hemoglobin at Week 13.|Week 13|Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 postbaseline hemoglobin evaluation.|||Percentage of participants|||Number
1428219|NCT01024036|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman’s disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC).|From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
1428220|NCT01024036|Secondary|Median Duration of Tumor Response - by Independent Radiology Review|Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)|All randomized participants who achieved tumor response during blinded treatment period as per independent review.|||Days||Full Range|Median
1428221|NCT01024036|Secondary|Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review|Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)|Response-evaluable Population: included participants who received at least 1 administration of siltuximab/placebo and had at least 1 post-baseline radiologic disease evaluation.|||Percentage of participants|||Number
1428240|NCT01023958|Secondary|Cmax of Volasertib|Maximum measured concentration in plasma (Cmax) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428241|NCT01023958|Secondary|AUC0-∞ of Volasertib|Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|Pharmacokinetic set (PKS) including patients with analyzable data for this endpoint.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1428222|NCT01024036|Secondary|Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review|Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. Symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.|From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years)|All randomized participants who achieved durable tumor and symptomatic response during blinded treatment period as per independent review.|||Days||Full Range|Median
1428223|NCT01024036|Primary|Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review|Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman’s disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care [BSC] minus Placebo+BSC).|From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier|Intent-to-treat (ITT) population: all randomized participants.|||Percentage of participants|||Number
1428224|NCT01023958|Secondary|Laboratory Investigation: Total Bilirubin|Difference from baseline in laboratory parameter total Bilirubin|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available total bilirubin data.|||umol/L||Standard Deviation|Mean
1428225|NCT01023958|Secondary|Laboratory Investigation: Creatinine|Difference from baseline in laboratory parameter Creatinine|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available creatinine data.|||umol/L||Standard Deviation|Mean
1428226|NCT01023958|Secondary|Laboratory Investigation: Alkaline Phosphatase|Difference from baseline in laboratory parameter Alkaline phosphatase|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available alkaline phosphate data.|||U/L||Standard Deviation|Mean
1428227|NCT01023958|Secondary|Laboratory Investigation: ALT/GPT, SGPT|Difference from baseline in laboratory parameter Alanine aminotransferase(ALT)/GPT, SGPT|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available ALT/GPT, SGPT data.|||U/L||Standard Deviation|Mean
1428228|NCT01023958|Secondary|Laboratory Investigation: AST/GOT, SGOT|Difference from baseline in laboratory parameter Aspartate aminotransferase(AST)/GOT, SGOT|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available AST/GOT, SGOT data.|||U/L||Standard Deviation|Mean
1428229|NCT01023958|Secondary|Laboratory Investigation: Lymphocytes|Difference from baseline in laboratory parameter Lymphocytes|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available lymphocytes data.|||10^9 cells/L||Standard Deviation|Mean
1428230|NCT01023958|Secondary|Laboratory Investigation: Neutrophils|Difference from baseline in laboratory parameter Neutrophils|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available neutrophils data.|||10^9 cells/L||Standard Deviation|Mean
1428231|NCT01023958|Secondary|Laboratory Investigation: Platelets|Difference from baseline in laboratory parameter Platelets|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available platelets data.|||10^9 cells/L||Standard Deviation|Mean
1428232|NCT01023958|Secondary|Laboratory Investigation: White Blood Cell Count|Difference from baseline in laboratory parameter white blood cell count|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available white blood cell count data.|||10^9 cells/L||Standard Deviation|Mean
1428233|NCT01023958|Secondary|Laboratory Investigation: Haemoglobin|Difference from baseline in laboratory parameter Haemoglobin|Baseline and last value on treatment (up to 2 years)|TS. Results displayed for patients with available haemoglobin data.|||g/L||Standard Deviation|Mean
1428234|NCT01023958|Secondary|Occurrence of Unacceptable Toxicity|Occurrence of unacceptable toxicity is defined by CTCAE as as drug related CTCAE Grade 3 or greater non-hematological toxicity (except emesis or diarrhea responding to supportive treatment); drug-related CTCAE Grade 4 neutropenia for seven or more days and / or complicated by infection; or drug-related CTCAE Grade 4 thrombocytopenia.|From first drug administration up to 21 days after final administration, up to 2 years|TS|||Percentage of participants|||Number
1428235|NCT01023958|Secondary|Occurrence and Intensity of AE's Graded According to CTCAE|"Occurrence and intensity of adverse events (AEs) graded according to Common Toxicity Criteria of Adverse Events (CTCAE).~The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)."|From first drug administration until end of study, up to 2 years|TS|||Percentage of participants|||Number
1428236|NCT01023958|Secondary|Tmax of Volasertib|Time from dosing to maximum measured concentration (Tmax) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||Hours||Full Range|Median
1428237|NCT01023958|Secondary|Vss of Volasertib|Apparent volume of distribution at steady state following intravascular administration (Vss) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||Litres||Geometric Coefficient of Variation|Geometric Mean
1428238|NCT01023958|Secondary|CL of Volasertib|Total plasma clearance after intravascular administration (CL) of volasertib|5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion|PKS including patients with analyzable data for this endpoint.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1428245|NCT01023958|Secondary|Overall Survival|"Overall survival (OS) is the time from first infusion to death. Patients who were alive at the time of analysis or lost to follow-up were censored at the last follow-up date when they were known to be alive.~Overall survival was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals."|Time from first infusion to death, up to 2 years|TS|||Months||95% Confidence Interval|Median
1428246|NCT01023958|Secondary|Progression-free Survival|"Progression-free survival (PFS) is the time from first treatment to the occurrence of tumor progression or death, whichever occurs first. Disease progression is defined according to the RECIST guideline but also includes the investigators’ assessment which may, in some cases, include only clinical progression (deterioration of general health status per investigator). PFS was analyzed with the Kaplan-Meier curve. Greenwood's variance estimate was used to form confidence intervals.~Patients without evidence of disease progression were to be censored at the last image date."|Time from first treatment to the occurrence of tumor progression or death, up to 2 years|TS|||Weeks||95% Confidence Interval|Median
1428247|NCT01023958|Primary|Objective Tumour Response According to RECIST Criteria|Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.|From first drug administration until end of study, up to 2 years|TS|||Percentage of participants||95% Confidence Interval|Number
1428248|NCT01023841|Primary|Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score|The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1428249|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.|||Intensity units||Standard Deviation|Mean
1428250|NCT01023841|Secondary|Change From Baseline in Upper Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent-to-treat population, that included all randomized participants, with data available at Baseline and Month 4.|||mm^2||Standard Deviation|Mean
1428251|NCT01023841|Secondary|Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent-to-treat population included all randomized participants.|||mm||Standard Deviation|Mean
1428252|NCT01023841|Primary|Percentage of Participants With Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|5 Months|Safety population included all randomized participants who received treatment.|||Percentage of participants|||Number
1428253|NCT01023815|Secondary|Change in Serum Creatinine|Serum creatinine (a blood measurement) is an important indicator of renal health because it is an easily-measured by-product of muscle metabolism. Measuring serum creatinine is a simple test and it is the most commonly used indicator of renal function.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||mg/dL||Standard Deviation|Mean
1428254|NCT01023815|Secondary|Change in Estimated Creatine Clearance|At each visit, estimated creatinine clearance was measured in the local laboratory to analyze the evolution of the renal function. The following indirect measures of renal function were computed: estimated creatinine clearance according to Cockcroft and Gault formula and MDRD formula.|M3, M12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||mL/min||Standard Deviation|Mean
1428255|NCT01023815|Secondary|Number of Participants With Graft and Patient Survival After Randomization|"Graft Survival, calculated from the date of transplantation to the date of irreversible graft failure signified by return to long‐term retransplantation or the date of the last follow‐up during the period when the transplant was still functioning or to the date of death.~Patient survival, calculated from the date of transplantation to the date of death or the date of the last follow‐up."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||Participants|||Number
1428256|NCT01023815|Secondary|Biopsy Proven Acute Rejection (BPAR) Rate Between Randomization and Month 12|"Occurrence of BPAR (after randomization) between arm B (steroid withdrawal group) and arm c (standard twice-a-day group).~BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III according to Banff 1997 grading with 2007 update."|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||Participants|||Number
1428257|NCT01023815|Secondary|Changes in the Estimated Glomerular Filtration Rate (eGFR) Between Randomization (Month 3) and Month 12|eGFR by Nankivell, in terms of descriptive statistics and change vs randomization visit - to compare the changes in the estimated GFR (Nankivell) between randomization and Month 12 in the steroid withdrawal group (Group B) to the change observed in the standard twice-a-day group (Group C), for non-inferiority|Month 3 to Month 12|ITT population, defined as all randomized patients who received at least one dose of study drug after Visit 5 (Day 90) and have at least one post-baseline assessment of the primary efficacy variable (i.e. treatment failure).|||mL/min||Standard Deviation|Mean
1444035|NCT00904371|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||mm Hg||Standard Deviation|Mean
1428258|NCT01023815|Primary|Treatment Failure Rate|Occurrence or not of treatment failure in each patient. Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection (a biopsy graded IA, IB, IIA, IIB or III according to Banff ’97 grading with 2007 update), graft loss, death or lost to follow-up occurring after randomization (V5) and within M12 (V9).|Between randomization (Month 3) and Month 12|ITT population: all randomized pts who received at least one dose of study drug after Visit 5 & have at least one post-baseline assessment of the primary efficacy variable. Change in study design stopped the randomization into Group A, due to overall slow enrollment rate & shifted all relative objectives to exploratory, due to small sample size.|||Participants|||Number
1428259|NCT01023789|Secondary|Calculated Diameter Stenosis|The value calculated as 100 * (1 – Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||Percent Diameter stenosis||Standard Deviation|Mean
1428260|NCT01023789|Secondary|Calculated Minimum Lumen Diameter|The average of two orthogonal views (when possible) of the narrowest point within the area of assessment – treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.|18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm||Standard Deviation|Mean
1428261|NCT01023789|Secondary|Mean Reference Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428262|NCT01023789|Secondary|Maximum Plaque Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428263|NCT01023789|Secondary|Minimum Plaque Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428264|NCT01023789|Secondary|Mean Plaque Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428265|NCT01023789|Secondary|Maximum Lumen Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428266|NCT01023789|Secondary|Mean Lumen Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428267|NCT01023789|Secondary|Maximum Vessel Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428268|NCT01023789|Secondary|Minimum Vessel Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428269|NCT01023789|Secondary|Mean Vessel Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428270|NCT01023789|Secondary|Minimum Lumen Area||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||mm^2||Standard Deviation|Mean
1428271|NCT01023789|Secondary|Area Stenosis (%)||18 months|Multislice computed tomography (MSCT) subgroup. A subset of up to 100 subjects who receive at least one Absorb BVS at selected sites with MSCT capability will be assessed using MSCT at 18 months. Subjects are only counted once for each type of event in each time period.Subjects without the required follow-up are excluded from the time period.|||Percentage||Standard Deviation|Mean
1428405|NCT01023061|Secondary|Median Time to Prostate Specific Antigen Progression|Defined as the date of an increase of 2ng/mL or more above the Prostate specific antigen nadir achieved after completion of radiation with the date of progression defined as the date on which that value was measured. Distribution of time-to-event variables will be estimated using the Kaplan-Meier product-limit method. Estimated with two-sided 95% confidence intervals.|6 months|Treated patients|||years||Standard Deviation|Mean
1428272|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 3 years|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428273|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 2 years|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428274|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis (Very Late)|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target segment revascularization."|366 days to 2 years|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428275|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 1 year|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428276|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis (Late)|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target segment revascularization."|31 - 365 days|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428277|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis|"According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 180 days|ITT population (Per Subject Analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428290|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||percentage of participants|||Number
1428278|NCT01023789|Secondary|Number of Participants With Scaffold Thrombosis (Early)|"According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing:~Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation~*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).~†Including “primary” as well as “secondary” late stent thrombosis; “secondary” late stent thrombosis is a stent thrombosis after a target segment revascularization."|0 to 30 days|ITT population (Per Subject Analysis)|||Participants|||Count of Participants
1428279|NCT01023789|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428280|NCT01023789|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 2 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428281|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428282|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 2 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428283|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428284|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428285|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428286|NCT01023789|Secondary|Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (Q wave and Non-Q wave),~Ischemia-driven target vessel revascularization by CABG or PCI."|≤ 7 days post index procedure (In hospital)|ITT population (per subject analysis).|||Participants|||Count of Participants
1428287|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428288|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428289|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428432|NCT01022853|Secondary|Cmax of Nintedanib|"Maximum measured concentration (Cmax) of Nintedanib in Cycle 1.~400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient."|5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9|PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428291|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 3 years|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428292|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428293|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428294|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428295|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428296|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 2 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428297|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428298|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428299|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428300|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428301|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428302|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428359|NCT01023516|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428303|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428304|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428305|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428306|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428307|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428308|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428309|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428310|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428311|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428312|NCT01023789|Secondary|Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)||≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
1428313|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|"Revascularization in the target vessel associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
1428314|NCT01023789|Secondary|Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)|"Revascularization at the target lesion associated with any of the following:~Positive functional ischemia study.~Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).~Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study."|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
1428315|NCT01023789|Secondary|Number of Participants With Myocardial Infarction (MI) - Per Protocol|Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
1428316|NCT01023789|Secondary|Number of Participants With Cardiac Death|Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|≤ 7 days post index procedure (In-hospital )|ITT population (per subject analysis).|||Participants|||Count of Participants
1428317|NCT01023789|Secondary|Clinical Procedure Success|Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.|On day 0 (immediate post-index procedure)|ITT population (Per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||percentage of participants|||Number
1428318|NCT01023789|Secondary|Clinical Device Success|Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.|On day 0 (immediate post-index procedure)|ITT population (Per Lesion analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||percentage of lesions|Target Lesions||Number
1428319|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 1 year|ITT population (per subject analysis). Subjects with the required follow-up are only counted once for each type of event in each time period. Subjects without the required follow-up are excluded from the time period.|||Participants|||Count of Participants
1428320|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).|0 to 180 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428321|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),~Ischemia-driven target lesion revascularization (TLR) by CABG or PCI."|0 to 30 days|ITT population (per subject analysis).|||Participants|||Count of Participants
1428322|NCT01023789|Primary|Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)|"The composite endpoint composed of~Cardiac death,~Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),~Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI)."|≤ 7 days post index procedure (In hospital)|ITT population (per subject analysis).|||Participants|||Count of Participants
1428323|NCT01023776|Secondary|Mean Difference Between Cycle Time and Detection Threshold|The mean difference was calculated by real-time polymerase chain reaction (PCR) on nasal wash samples. Cycle time is the cycle number at which the PCR reaction is positive with a range of 0-40 cycles. The detection threshold is 40 cycles.|day 10 post vaccine 1|per protocol|||cycles||95% Confidence Interval|Mean
1428324|NCT01023776|Primary|Number of Participants Who Shed Virus|number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.|28 days post vaccine 1 and 28 days vaccine 2|per protocol|||participants|||Number
1428325|NCT01023724|Primary|Anterior Chamber Inflammation (Flare)|Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.|Day 14 of treatment||||photon count per msec (pc/ms)||Standard Deviation|Mean
1428326|NCT01023711|Secondary|Assessment of the Reactogenicity Events Post Vaccination.|Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination|7 days|Subjects who completed the 7 day diary card|||participants|||Number
1428327|NCT01023711|Primary|Determination of Immune Response to Vaccination.|Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination|28 days|All subjects who completed Day 28 visit post vaccination were analyzed.|||participants|||Number
1428328|NCT01023672|Primary|Mean Initial Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|"The MWT measures the subject's ability to stay awake while sitting quietly in a chair. The test has 4 parts, each lasting 40 minutes if the subject is able to remain awake that long each time, and the parts are spaced apart in 2 hour intervals through the day.~The subject is placed in a dim room, with the only source of light slightly behind the subject's head and out of his/her field of vision, and back and neck supported. During this time the subject is monitored with the same measures that are used in a standard overnight sleep study called a polysomnogram. The sleep latency, or time it takes the subject to fall asleep, will be recorded.~In healthy people, the time it takes to fall asleep may be approximately 30 minutes on the test. More than 97% of people will take eight minutes or longer to fall asleep. Therefore, sleep latency that is less than eight minutes is considered to be abnormal."|baseline, 12 weeks|Per Protocol; 3 subjects did not complete the study (2 had worsening disease, and 1 died) and did not complete this test.|||minutes||Inter-Quartile Range|Median
1428329|NCT01023659|Primary|Proportion of Eligible Participants Who Were Able to Attend an Appointment With a Physician|Proportion of eligible participants who were able to attend an appointment with a physician to have the prescription signed|End of Treatment|total number of eligible participants in study|||Participants|||Count of Participants
1428330|NCT01023659|Primary|7-day Point Prevalence of Abstinence|"7-day point prevalence of abstinence was assessed by the question Have you had a cigarette, even a puff, in the past 7 days?"|6-month|Number of eligible participants who either received bupropion + motivational emails, varenicline + motivational emails or motivational emails alone (because they either did not attend a physician visit or their physician decided not to prescribe them bupropion or varenicline)|||Participants|||Count of Participants
1428331|NCT01023581|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.|Full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. Includes only data collected on or after baseline and within 1 day after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.|||mg/dL||Standard Error|Least Squares Mean
1428386|NCT01023308|Primary|Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months|Full Analysis Set|||months||95% Confidence Interval|Median
1428332|NCT01023581|Secondary|Change From Baseline in HbA1c Over Time|"The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20.~Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate."|Baseline and Weeks 4, 8, 12, 16, and 20.|The full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. The analysis includes only data collected on or after baseline and within 7 days after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1428333|NCT01023581|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).|Baseline and Week 26.|Full analysis set (patients who took at least 1 dose of study medication) where baseline and at least 1 postbaseline assessment were available. Analysis includes only data collected on or after baseline and within 7 days after last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1428334|NCT01023568|Secondary|Number of Participants Who Experienced Desaturation|Desaturation was defined as SpO2 less than 90% at induction time or any time from intubation to 10 minutes after|measured at 1 minute interval at induction time and from intubation for 10 minutes.||||participants|||Number
1428335|NCT01023568|Secondary|Mean Hemodynamic Response: Heart Rate||measured at 1 minute interval at induction time and from intubation for 10 minutes.||||beats/min||Standard Deviation|Mean
1428336|NCT01023568|Secondary|Cormack-Lehane Grade||immediately after intubation||||participants|||Number
1428337|NCT01023568|Secondary|Mean Hemodynamic Response: Mean Arterial Blood Pressure||measured at 1 minute interval at induction time and from intubation for 10 minutes||||mmHg||Standard Deviation|Mean
1428338|NCT01023568|Primary|Time to Successfully Intubate Patient.||from start of intubation to successfully intubated up to 5 minutes||||seconds||Inter-Quartile Range|Median
1428339|NCT01023516|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation.|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Participants|||Number
1428340|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).Questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
1428341|NCT01023516|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Deviation|Mean
1428342|NCT01023516|Secondary|Endurance Shuttle Walk Test - End Value|Assessed at vist 6 -( last on treatment clinic visit)|Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Error|Least Squares Mean
1428343|NCT01023516|Secondary|Endurance Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Deviation|Mean
1428344|NCT01023516|Secondary|Incremental Shuttle Walk Test - End Value||Week 12 - visit 6|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Error|Least Squares Mean
1428345|NCT01023516|Secondary|Incremental Shuttle Walk Test - Baseline|Endurance time (s)|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||seconds||Standard Deviation|Mean
1428346|NCT01023516|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||inhalations||Standard Error|Least Squares Mean
1428387|NCT01023308|Primary|Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||number of events|||Number
1428347|NCT01023516|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status). End of treatment week 12|End of treatment week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
1428348|NCT01023516|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Deviation|Mean
1428349|NCT01023516|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
1428350|NCT01023516|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Deviation|Mean
1428351|NCT01023516|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
1428352|NCT01023516|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Deviation|Mean
1428353|NCT01023516|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428354|NCT01023516|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428355|NCT01023516|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak expiratory flow (PEF)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1428356|NCT01023516|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning. Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Deviation|Mean
1428357|NCT01023516|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428358|NCT01023516|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428360|NCT01023516|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory capacity (IC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428361|NCT01023516|Secondary|End-value Post-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Error|Least Squares Mean
1428362|NCT01023516|Secondary|Baseline Post-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Deviation|Mean
1428363|NCT01023516|Secondary|End-value Pre-bronchodilator FEF25-75% (L/Sec)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Error|Least Squares Mean
1428364|NCT01023516|Secondary|Baseline Pre-bronchodilator FEF25-75% (L/Sec)|Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/sec||Standard Deviation|Mean
1428365|NCT01023516|Secondary|End-value Post-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428366|NCT01023516|Secondary|Baseline Post-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428367|NCT01023516|Secondary|End-value Pre-bronchodilator FEV6 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428368|NCT01023516|Secondary|Baseline Pre-bronchodilator FEV6 (L)|Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428369|NCT01023516|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428370|NCT01023516|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428371|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428372|NCT01023516|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428373|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428374|NCT01023516|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428375|NCT01023516|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|up to week 12|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1428376|NCT01023516|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1428377|NCT01023308|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group|Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.|12, 24 and 48 weeks|Full Analysis Set|||score on a scale||95% Confidence Interval|Least Squares Mean
1428378|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group|"The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set|||score on a scale||95% Confidence Interval|Least Squares Mean
1428379|NCT01023308|Secondary|European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group|"Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome), All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms."|12, 24 and 48 weeks|Full Analysis Set|||score on a scale||95% Confidence Interval|Least Squares Mean
1428380|NCT01023308|Secondary|Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||months||95% Confidence Interval|Median
1428381|NCT01023308|Secondary|Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||duration of response in months||95% Confidence Interval|Median
1428382|NCT01023308|Secondary|Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.||45 months||||time to response in months||95% Confidence Interval|Median
1428383|NCT01023308|Secondary|Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.|Best overall response based on mEBMT criteria per investigator assessment|45 months||||% participants with response|||Number
1428384|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|survival time in months|45 months|FAS|||months||95% Confidence Interval|Median
1428385|NCT01023308|Secondary|Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone|Number of OS events|45 months||||Number of OS events|||Number
1428404|NCT01023074|Primary|Electrophysiological Auditory Test|"auditory P300 amplitude in response to rare 1000 Hz tones"|Recordings were conducted during one session||||microvolts||Standard Deviation|Mean
1428388|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 8|At week 8, MRI data were not available for 6 placebo patients, 5 MOR103 0.3 mg/kg patients, 1 MOR103 1.0 mg/kg patient, and 2 MOR103 1.5 mg/kg patients.|||units on a scale||Standard Deviation|Mean
1428389|NCT01023256|Secondary|Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8|Patient-reported outcomes included patient’s self-assessment of pain (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale [VAS] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best).|Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8|All treated patients|||units on a scale||Standard Deviation|Mean
1428390|NCT01023256|Secondary|Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8|Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.|Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8|All treated patients|||joints||Standard Deviation|Mean
1428391|NCT01023256|Secondary|Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4|The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.|Week 4 (1 week after last MOR103 dose)|All participants were included in ACR response calculations. Patients lacking data required for calculation of an ACR response were considered as not having an ACR response. 1 patient in the MOR103 0.3 mg/kg group, 1 patient in the MOR103 1.0 mg/kg group, and 5 patients in the pooled placebo group had missing data for ACR calculations.|||percentage of participants|||Number
1428392|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity)|Change from baseline to week 8 (5 weeks after last MOR103 dose)|All treated patients|||units on a scale||Standard Deviation|Mean
1428393|NCT01023256|Other Pre-specified|Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4|Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.|Change from screening to week 4 (1 week after last MOR103 dose)|At week 4, MRI data were not available for 5 placebo patients, 2 MOR103 0.3 mg/kg patients, 2 MOR103 1.0 mg/kg patients, and 1 MOR103 1.5 mg/kg patient.|||units on a scale||Standard Deviation|Mean
1428394|NCT01023256|Secondary|Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks|The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).|Change from baseline to week 4 (1 week after last MOR103 dose)|All treated patients|||units on a scale||Standard Deviation|Mean
1428395|NCT01023256|Primary|Percentages of Patients With Treatment-emergent or Serious Adverse Events|Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of >5 % (>1 patient) in any treatment group, please see the adverse events listing.|From the first dose through the 16-week visit|All patients who received treatment.|||percentage of participants|||Number
1428396|NCT01023217|Secondary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 104 from randomization|||||||
1428397|NCT01023217|Secondary|Normalization of ALT Level||at week 52 and at week 104 from randomization|||||||
1428398|NCT01023217|Secondary|Genotypic Resistance to ADV or ETV||at week 52 and at week 104 from randomization|||||||
1428399|NCT01023217|Secondary|Reduction in Serum HBV DNA Levels||at week 52 and at week 104 from randomization|||||||
1428400|NCT01023217|Primary|Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL)||at week 52 from randomization||||participants|||Number
1428401|NCT01023178|Primary|Estradiol|Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy.|end of study (up to 2 years)||||pg/mL||Standard Error|Mean
1428402|NCT01023074|Secondary|SCAN-A: Competing Words Test|The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance.|Test administered during one session||||units on a scale||Standard Deviation|Mean
1428403|NCT01023074|Secondary|Neural Magnetic Resonance Imaging (MRI)|Gray matter volume|Results were recorded during one scanning session|Data reported for 47 study participants who underwent MRI|||cubic cm||Standard Deviation|Mean
1428406|NCT01023061|Primary|Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry|The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care.|Week 12|Treated patients with measurable tissue DHT|||pg/mg||90% Confidence Interval|Median
1428407|NCT01023061|Primary|Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.|Up to 24 months after initiation of radiation therapy|Treated patients|||Participants|||Count of Participants
1428408|NCT01023035|Secondary|Percentage of Participants Who Discontinued Treatment|Cumulative discontinuation was defined as the sum of discontinuations due to adverse events, viral breakthrough/resistance, detectable HCV-RNA and futility rules (<2-log10 decline in HCV-RNA at Treatment Week 12, ≥ Lower Limit of Quantification [LLQ] HCV-RNA at Treatment Week 24), and other (noncompliance, withdrawal of consent, lost to follow-up).|From Study Day 1 up to Study Treatment Week 48|All Treated Participants, defined as all participants who were treated with any study medication.|||percentage of participants||95% Confidence Interval|Number
1428409|NCT01023035|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable plasma Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week 24|At Follow-up Week 24|The primary efficacy analysis was performed on all participants who were randomized to either the RBV Dose Reduction Arm or the EPO Use Arm for anemia management (i.e. the Full Analysis Set of patients requiring anemia management [FAS, n=500]).|||percentage of participants|||Number
1428410|NCT01023022|Secondary|Handling of Unscheduled Activities (for Example, Symptoms and Events)|"Investigators were asked to classify reasons for unscheduled visits by marking all applicable answers. Answer: 1) patient symptoms 2) adequate therapy/shock 3) appearance of already known arrythmias 4) appearance of new arrythmias 5) need for reprogramming 6) in house Follow-up 7) device alert 8) inadequate therapy/shock 9) worsening of pump function 10) malfunction of the device 11) other"|Baseline to max. 12 months|The 68 patients of total population (176) were analyzed as this number of pt. had experienced unscheduled visit during the study.|||% of unscheduled visits due to reasons|unscheduled visits||Number
1428411|NCT01023022|Secondary|Efficiency Through Increased Flexibility and Per Procedure Time||Baseline to max. 12 months|||||||
1428412|NCT01023022|Secondary|Time and Costs Savings for Physicians||Baseline to max. 12 months|||||||
1428413|NCT01023022|Secondary|Time and Cost Savings for Patients||Baseline to max. 12 months|||||||
1428414|NCT01023022|Secondary|Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility)||Baseline to max. 12 months|||||||
1428415|NCT01023022|Secondary|Clinician Ease of Use of, and Satisfaction With, the Medtronic CareLink® Monitor and Website (Including Clinician General Preference, if Any, for Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)||Baseline to max. 12 months|||||||
1428416|NCT01023022|Secondary|Patient Ease of Use of, and Satisfaction With the Medtronic CareLink® Monitor (Including Percentage of Patients Who Prefer Follow up With Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up)|"Participants were asked questions to which they could have respond multiple answers. 1) Which form of device follow up do you prefer? Answers: Monitor from home and in hospital follow up is necessary; Follow up only in hospital; No preference, and 2) How would you judge the user friendliness of the monitor in total? Answers: Very easy; Easy; Difficult; Missing Data, and 3) How did the monitor changed your daily life? did you felt more or less safe? Answers: Much more safe; Safe; No influence; Unsafe; Missing data"|Baseline to max. 12 months|Number of patients who provided responses for these questions at the end of the Study.|||percentage of patients|||Number
1428417|NCT01023022|Primary|Comparison of Remote Device Check and In-clinic Device Assessment|"Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"|Baseline to max. 12 months|Number of Investigators who provided responded for these questions at the end of evaluation.|||percentage of Investigators|||Number
1428418|NCT01022996|Secondary|Progression Free Survival (PFS) by Kaplan-Meier Estimate|Progression-free survival (PFS) was defined as the time from the first date of treatment to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. An event for PFS was defined as a documented disease progression or death due to any cause or start of a new antineoplastic therapy, whichever occurred first. Cycle = 28 days.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||95% Confidence Interval|Median
1428419|NCT01022996|Secondary|Duration of Disease Control|The duration of overall response (CR/PR) was applied only to patients whose best overall response was CR or PR. Duration of overall response was calculated from the date of the first documented response of CR or PR to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||Standard Deviation|Mean
1428420|NCT01022996|Secondary|Disease Control Rate (DCR)|The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Percentage of participants||95% Confidence Interval|Number
1428421|NCT01022996|Secondary|Duration of Overall Response (DoR)|The duration of overall response was calculated from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. This only applies to patients whose best overall response is CR or PR.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||Standard Deviation|Mean
1428422|NCT01022996|Secondary|Time to Overall Response (TTR) Per Kaplan-Meier Estimate|Time to overall response was defined as the time from the first date of treatment to the date of first documented response of CR or PR. Time to overall response is applied to patients whose best overall response is CR or PR. Patients who drop-out or did not have a response (CR or PR) will be treated as censored at the date of last adequate tumor assessment.|Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||Days||95% Confidence Interval|Median
1428423|NCT01022996|Primary|Overall Response Rate (ORR) Based on the Assessments by Investigator|ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal & extranodal lesions: Radiological regression to normal size of all lymph nodes & nodal masses & complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal & extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal & extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented & one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.|at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason|Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.|||percentage of participants|||Number
1428424|NCT01022853|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from start of treatment with study medication to tumour progression or death whichever occurs first. Tumour response was to be documented using appropriate techniques such as magnetic resonance imaging (MRI) or computer tomography (CT).|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||days||Full Range|Median
1428425|NCT01022853|Secondary|Duration of Disease Control|Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Patients who had a best overall tumour response of complete response (CR), partial response (PR) or stable disease (SD) were assessed to show disease control.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|All patients of the treated set that were assessed to show disease control.|||days||Full Range|Median
1428426|NCT01022853|Secondary|Number of Patients With Disease Control|Disease control based on response evaluation criteria in solid tumors (RECIST) version 1.1. Disease control is defined as complete response (CR), partial response (PR) or stable disease (SD) as best response throughout the study.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||participants|||Number
1428427|NCT01022853|Primary|Maximum Tolerated Dose (MTD) of Volasertib in Combination With Nintedanib|The MTD was determined using a 3+3 design with de-escalation. The MTD was defined as the highest dose level at which maximal 1 out of 6 patients experienced DLT in the first course of the escalation nd de-escalation phase. However, all DLT's occurring in the trial were considered for selection of the recommended dose for further development.|28 days|Treated Set. All patients who received >= 1 dose of study medication.|||mg|||Number
1428428|NCT01022853|Secondary|Number of Patients With Objective Response (OR)|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR) as best response throughout the study.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||participants|||Number
1428429|NCT01022853|Secondary|Number of Patients With Best Overall Response|Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as the best overall response (complete response, partial response, stable disease, progressive disease or not evaluable) since the start of treatment.|Tumor assessment was performed at screening and every 2nd course until earliest time of progression, death or end of treatment.|Treated Set.|||participants|||Number
1428430|NCT01022853|Secondary|Tmax of Nintedanib|"Time from dosing to the maximum measured concentration, Cmax, of Nintedanib (tmax) in Cycle 1.~400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient."|5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9|PK analysis set.|||h||Full Range|Median
1428431|NCT01022853|Secondary|AUC(0-6h) of Nintedanib|"Area under the concentration-time curve (AUC) of Nintedanib over the time interval 0 to 6 hours in Cycle 1.~400 mg Volasertib + 200 mg Nintedanib group is not displayed due to data only being available for one patient."|5 min before Nintedanib administration in the morning and 1:00, 2:00, 3:00, 4:00, 6:00 h after administration on Day 9|PK analysis set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1428435|NCT01022853|Secondary|Cmax of Volasertib|Maximum measured concentration (Cmax) in plasma of Volasertib in Cycle 1.|0:05 h before start of Volasertib infusion and 1:00, 2:00, 3:00, 4:00, 8:00 and 24 h after start of Volasertib infusion|Pharmacokinetic (PK) analysis set. The PK analysis set included all patients who took at least 1 dose of study medication and provided at least 1 blood sample following drug administration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428436|NCT01022853|Secondary|Number of Participants With Dose Limiting Toxicities|"Number of participants with dose limiting toxicities (DLTs).~DLT was defined as:~Drug-related CTCAE grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or~Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or~CTCAE grade 4 thrombocytopenia"|From first study drug administration until 28 days after the last administration of any study medication, up to 485 days|Treated Set.|||participants|||Number
1428437|NCT01022853|Secondary|Number of Participants With Drug Related Adverse Events|Number of participants with investigator-defined drug related adverse events.|From first study drug administration until 28 days after the last administration of any study medication, up to 485 days|Treated Set.|||participants|||Number
1428438|NCT01022853|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD).|"DLT was defined as:~Drug-related CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 non-haematological toxicity (except untreated vomiting, untreated nausea, or untreated diarrhoea) or~Drug-related CTCAE grade 4 neutropenia for 7 or more days and/or complicated by infection or~CTCAE grade 4 thrombocytopenia"|28 days|Treated set. All patients who received ≥1 dose of study medication were included in the treated set.|||participants|||Number
1428439|NCT01022762|Secondary|Change in Body Weight||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation|||kg||Standard Error|Least Squares Mean
1428440|NCT01022762|Secondary|Cholesterol|"The number of participants having a change in cholesterol from normal to abnormal. Abnormal means a value of blood cholesterol is out of the normal range."|Week 0, week 16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s)|||participants|||Number
1428441|NCT01022762|Secondary|Number of All Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product and no later than the last day of the trial product.|Weeks 0-16|Safety analysis set contains all randomised participants exposed to at least one dose of trial drug(s). One participant was randomised into repaglinide group, but was dispensed gliclazide from the very beginning of the study due to the investigator's negligence. This participant continued the gliclazide treatment until the end of the study.|||episodes|||Number
1428442|NCT01022762|Secondary|Change in AUC0-180 of Plasma Glucose Concentration of IVGTT||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.|||min*mmol/L||Standard Deviation|Mean
1428443|NCT01022762|Secondary|Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)||Over the course of three hours at Week 0 and Week 16|A total of 69 participants were recruited into IVGTT, and were randomised into repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants). Participants with eligible IVGTT profiles were included in IVGTT analysis set.|||min*pmol/L||Standard Deviation|Mean
1428444|NCT01022762|Secondary|Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
1428445|NCT01022762|Secondary|Change in Fasting Serum Free Fatty Acid (FFA) From Baseline||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
1428446|NCT01022762|Secondary|Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%||Week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||percentage of participants|||Number
1428447|NCT01022762|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal|A standard meal contains 100g carbohydrate|Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
1428448|NCT01022762|Secondary|Change in Fasting Plasma Glucose||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||mmol/L||Standard Error|Least Squares Mean
1428449|NCT01022762|Primary|Change in Glycosylated Haemoglobin (HbA1c)||Week 0, week 16|Full analysis set (FAS) is randomised participants exposed to at least one dose of trial product after randomisation. Missing values were replaced with the last post-baseline data based on LOCF (last observation carried forward).|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
1428450|NCT01022567|Secondary|The Recurrence of Conservatively Treated Appendicitis||up to 10 years||2022-06-30|06/2022||||
1428451|NCT01022567|Secondary|The Direct and Indirect Costs of Both Treatment Arms||1 year|||||||
1428452|NCT01022567|Secondary|The Possible Complications, Morbidity and Mortality of Operative and Conservative Treatment||1 year|||||||
1428453|NCT01022567|Primary|The Success of Antibiotic and Surgical Treatment in the Treatment of Acute Uncomplicated Appendicitis|A successful treatment is determined by resolution of the appendicitis by means of the assigned treatment.|Up to 10 years|Treatment success|||percentage of successful treatment||95% Confidence Interval|Number
1446637|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)||Baseline up to Month 7||||percentage of participants|||Number
1428455|NCT01022502|Secondary|Patients' Rating of the Overall Improvement at Week 8|At week 8, patients rated an overall response to treatment (separately for each side of the body), taking into account both the extent and the degree of the disease, compared with the pretreatment condition, on a 6-point scale (0=worse,1=poor, 2=fair, 3=good, 4=excellent, 5=cleared). A score of 4 or higher represents a better outcome.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention and who reported excellent or cleared at week 8 were used for analysis.|||participants|||Number
1428456|NCT01022502|Primary|Percentage Improvement Compared to Baseline in the Target Plaque.|The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared percent of improvement related to baseline between the two lesions and before treatment with those after treatment.|||percent change of target plaque||95% Confidence Interval|Mean
1428457|NCT01022502|Primary|Clearing Percentage of Target Plaque Area|The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared clearing percent of target plaque between the two lesions and before treatment with those after treatment.|||percentage of the target area||95% Confidence Interval|Mean
1428458|NCT01022502|Primary|Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.|The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement.|Baseline and Week 8|Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared PSI scores between the two lesions and before treatment with those after treatment.|||units on a scale||95% Confidence Interval|Mean
1428459|NCT01022424|Primary|Renal Function Test (eGFR)|Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period.|Baseline, Week 48, 96, 144, and 192||||mL/min/1.73 m2||Inter-Quartile Range|Median
1428460|NCT01022424|Primary|Total Kidney Volume|"Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.~Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site."|Baseline, Week 48, 96, 144, and 192||||mL||Inter-Quartile Range|Median
1428461|NCT01022398|Primary|Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy||6 months|||||||
1428462|NCT01022307|Primary|Performance on Trail-making Test, Part B|z-score based on response time, regressed for age and computer use|Single session generally several years after TBI depending on time of recruitment of subjects.|z-score|||z-score||Standard Deviation|Mean
1428463|NCT01022242|Primary|TAM2|The primary variable is TAM2: The sum of Total Active Motion at the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the affected digit at actively made fist minus the extensor lag at these joints.|At 12 weeks after surgery|FAS population|||Degrees||Full Range|Median
1428464|NCT01022203|Secondary|Emotion Regulation|Measured with the Difficulties in Emotion Regulation Scale which measures severity of emotion regulation problems (Scores range from 36-125 with higher scores indicating higher levels of emotion regulation problems).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.|||units on a scale||Standard Deviation|Mean
1428465|NCT01022203|Secondary|Relationship Functioning|Relationship functioning is defined as relationship adjustment; measured with the Dyadic Adjustment Scale. The Dyadic Adjustment Scale scores range from 0-151 with high scores indicating high levels of relationship adjustment.|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Data collected from 44 veterans participating in Structured Approach Therapy and 42 veterans participating in PTSD Family Education.|||units on a scale||Standard Deviation|Mean
1428466|NCT01022203|Primary|Psychological Functioning|Clinician-Rated PTSD measured with the Clinician Administered PTSD Scale (Score range 0-133 with high scores indicating more severe PTSD); Self-Rated PTSD measured with the PTSD Checklist (Score range 17-85 with high scores indicating more severe PTSD).|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).|Outcome data collected from 44 veterans who participated in Structured Approach Therapy and 42 Veterans who participated in PTSD Family Education.|||units on a scale||Standard Deviation|Mean
1428467|NCT01022190|Primary|Percentage of Participants With Heterotopic Ossification (HO) at 6 Months Postoperatively.|"Percentage of participants in which Heterotopic Ossification of the hip was assessed, according to the Brooker grade.~Brooker-0): No ossification. Brooker-1): Isolated bone islands, Brooker-2): Bone spurs from the pelvis or proximal femur;space between opposing surface ≥ 1 cm, Brooker-3): Bone spurs from the pelvis or proximal femur;space between opposing surface < 1 cm, Brooker-4): Apparent bony ankylosis. Brooker score 1 to 4 are considered 'heterotopic ossification'."|6 months postoperatively|Patients who underwent total hip arthroplasty and received afterwards Etoricoxib medication.|||percentage of participants|||Number
1428468|NCT01022112|Secondary|Safety and Tolerability||14 weeks|||||||
1428469|NCT01022112|Secondary|Fasting Blood Glucose, Body Weight||12 weeks|||||||
1428470|NCT01022112|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||12 weeks|Full analysis set, last observation carried forward|||percent HbA1C||Standard Error|Least Squares Mean
1428828|NCT01018511|Secondary|AUCss of Solifenacin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1428471|NCT01022073|Primary|Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)|The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher the value, the worse the outcome.|The change score of UPDRS Part III from baseline to 9 years post surgery|Patients had completed the 9 year follow-up post surgery|||units on a scale||Standard Deviation|Mean
1428472|NCT01021878|Secondary|Total Ultrafiltration|Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.|3 months||||millilitre||95% Confidence Interval|Mean
1428473|NCT01021878|Secondary|Glycated Hemoglobin|"Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.~Glycated hemoglobin was measured by high-performance liquid chromatography."|3 months||||percentage of haemoglobin||95% Confidence Interval|Mean
1428474|NCT01021878|Secondary|Serum Insulin|Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense.|3 months||||log(mmol/L)||95% Confidence Interval|Mean
1428475|NCT01021878|Secondary|Oral Fasting Serum Glucose|"Serum glucose measured in oral fasting but not peritoneal fasting.~For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at < 0.05."|3 months||||mg/dl||95% Confidence Interval|Mean
1428476|NCT01021878|Primary|Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor|"Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows:~(fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405"|3 months||||IR score||95% Confidence Interval|Mean
1428477|NCT01021852|Primary|Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|APaT population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.|||percentage of participants|||Number
1428478|NCT01021852|Primary|Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.|Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.|||percentage of participants|||Number
1428479|NCT01021852|Secondary|Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment|LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R&K scoring. LS mean LPS was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization LPS efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1428480|NCT01021852|Secondary|Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment|WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R&K criteria and PSG data were read by a Central Reader. WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. LS mean WASO was reported for each treatment arm.|Night 1 and end of Week 4|FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization WASO efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1428481|NCT01021852|Primary|Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment|SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization SE efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||percentage of time in bed spent sleeping||Standard Error|Least Squares Mean
1428482|NCT01021813|Other Pre-specified|Number of Participants Who Reported Suicidal Ideation and/or Behavior On Study Based on Responses to the Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidal ideation and/or behavior that occurred on study was also assessed using the C-SSRS, a rater-administered questionnaire used to prospectively assess suicidal ideation and suicidal behavior. C-SSRS assessment was based upon a clinician's interpretation of the participant's responses to the C-SSRS questions, not by a numbered scale.~Suicidal ideation and/or behaviors identified on the C-SSRS may not have been considered an adverse event, based on the investigator's judgment."|From the first day of study treatment through study follow-up (up to 14 months)|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||participants|||Number
1428483|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Time To Sleep Onset (sTSOm) During First Month of Treatment Phase|The sTSOm was defined as the average over time of daily e-diary values for a participant's report of the time he or she required to fall asleep (measured in minutes). Weekly sTSOm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSOm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.|||minutes||95% Confidence Interval|Least Squares Mean
1428484|NCT01021813|Secondary|Least Squares (LS) Mean Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) During First Month of Treatment Phase|The sTSTm was defined as the average over time of daily e-diary values for a participant's report of the total amount of time spent asleep before waking for the day (measured in minutes). Weekly sTSTm values (Week 1, Week 2, etc.) were the average of the daily e-diary values for the week. A summary value of this measure for Month 1 was obtained by taking the average of weekly sTSTm values for Weeks 1 through 4; (Week 1 + Week 2 + Week 3 + Week 4) ÷ 4. LS Mean Change from Baseline in sTSTm was then calculated at Week 1, Week 2, Week 3, Week 4, and Month 1.|Baseline, Week 1, Week 2, Week 3, and Week 4|Full Analysis Set (FAS)-Efficacy; all randomized participants who had ≥1 post-randomization observation for the analysis endpoint subsequent to ≥1 dose of study treatment, and baseline data for those analyses that required baseline data. The number included in the FAS may vary across endpoints due to the degree of missing data for each endpoint.|||minutes||95% Confidence Interval|Least Squares Mean
1428485|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Increased Subjective Time to Sleep Onset (sTSO) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective time to sleep onset (sTSO) as recorded in the participant’s morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTSO value (in minutes) on any of the first 3 nights of the Run-out Phase occurring after one year of treatment (Month 13) was greater than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.|||percentage of participants|||Number
1428486|NCT01021813|Secondary|Percentage of Participants With Rebound As Defined By Decreased Subjective Total Sleep Time (sTST) During the DB Run-Out Phase|Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia, and was assessed based on subjective total sleep time (sTST) as recorded in the participant’s morning e-diary. A strict categorical analysis method (Yes/No) was used in which a participant was considered to have potentially experienced rebound (Yes) if the Morning Diary participant-reported sTST value (in minutes) on any of the 3 nights of the Run-out Phase (first 3 nights of the Discontinuation Phase) occurring after one year of treatment (Month 13) was less than the last value at baseline one year earlier (Month 1).|Baseline (Month 1) and first 3 days of Randomized Discontinuation Phase (otherwise known as the Run-out, Month 13)|Participants in the APaT population who completed the entire DB Treatment Phase, had a baseline measurement, had taken at least one dose of DB Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.|||percentage of participants|||Number
1428497|NCT01021748|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which was temporally associated with the use of study drug was also an AE. The number of participants who experienced at least one AE is presented.|Up to approximately 23 months|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1428487|NCT01021813|Secondary|Percentage of Participants With Withdrawal Symptoms During the DB Run-Out Phase: Tyrer Withdrawal Symptom Questionnaire (WSQ)|"Withdrawal effects assessed using Tyrer WSQ, which evaluated the presence/absence and severity of withdrawal symptoms with 20 items (i.e. sensitivity to noise, light, smell, touch, feeling unreal, etc). The Tyrer WSQ was completed as part of the evening e-diary prior to dosing on the Month 12 visit and on the 3 consecutive evenings of the DB Run-out Phase (first 3 nights of DB Discontinuation Phase). Responses rated 0 (No), 1 (Yes-moderate), or 2 (Yes-severe); range from 0 (no withdrawal) to 40 (severe withdrawal).~A participant was defined to have a withdrawal symptom if an item during any of the 3 DB Run-out days had emerged for the first time, or had worsened compared to the measurement obtained at the end of the Treatment phase (Month 12). For single night analysis, a patient was defined to have withdrawal effects if the number of withdrawal symptoms (emergent or worsening) was ≥3. For across night analysis, withdrawal was defined as a total of ≥3 symptoms across the 3 nights."|Evening of Month 12 visit and next 3 consecutive days (Night 1, 2, and 3 of Discontinuation Phase [otherwise known as the Run-out])|Participants in the APaT population who completed the entire DB Treatment Phase, had at least one measurement at the end of the DB Treatment Phase (Month 12), had taken at least one dose of Run-out study medication, and had a measurement on at least one of the nights of the DB Run-out Phase.|||percentage of participants|||Number
1428488|NCT01021813|Primary|Percentage of Participants Who Experienced Selected AEs Associated With Potential for Abuse During the DB Treatment Phase|The pre-specified terms which were suggestive of abuse potential on this study included depersonalization (feeling of watching oneself act, while having no control over a situation), derealization (alteration in the perception or experience of the external world so that it seems unreal), dissociation (includes a wide array of experiences from mild detachment from immediate surroundings to more severe detachment from physical and emotional experience), euphoric mood (exaggerated feeling of physical and emotional well-being and optimism not consonant with apparent stimuli or events), mania (state of abnormally elevated or irritable mood, arousal, and/or energy levels), hallucination (perception in the absence of a stimulus which has qualities of real perception), and potential study medication misuse.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
1428489|NCT01021813|Primary|Percentage of Participants Who Experienced Hypnagogic/Hypnopompic Hallucinations AEs During the DB Treatment Phase|Perceptual distortions associated with transitions between wakefulness and sleep were termed as hypnagogic (occurring during the onset of sleep) or hypnopompic (occurring during onset of wakefulness) hallucinations.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
1428490|NCT01021813|Primary|Percentage of Participants Who Experienced Suicidal Ideation and/or Behavior AEs During the DB Treatment Phase|Suicidal ideation included suicidal plans, suicidal tendency, death wishes, life weariness, and suicidal intention. Suicidal behaviors included suicide attempts, suicide gesture, and self-injurious behaviour. Suicidal ideation and/or behavior was reported as an AE and considered an ECI.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
1428491|NCT01021813|Primary|Percentage of Participants Who Experienced Falls AEs During the DB Treatment Phase|Falls were adjudicated (to establish whether a fall event was due to cataplexy).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
1428492|NCT01021813|Primary|Percentage of Participants Who Experienced Complex Sleep-related Behaviors AEs During the DB Treatment Phase|Complex sleep-related behaviors were reported as ECIs and were characterized by patients engaging in specific activities while asleep (e.g., eating, drinking, preparing meals, making phone calls, having sex, driving, and sleep walking).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
1428493|NCT01021813|Primary|Percentage of Participants Who Experienced Sleep Paralysis AEs During the DB Treatment Phase|Sleep paralysis was defined as the inability to perform voluntary muscle movements during sleep. Sleep paralysis adverse events included sleep-onset paralysis (paralysis as one is falling asleep).|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment|||percentage of participants|||Number
1428494|NCT01021813|Primary|Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase|Cataplexy is defined as a sudden loss of muscle tone while awake which prevents voluntary movement.|From the first day of study treatment up to 12 months|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants|||Number
1428495|NCT01021761|Primary|Aqueous PGE2 Inhibition|A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection.|Day 4 of treatment|Protocol specified 126 subjects to be enrolled and analysis was performed per protocol.|||pg/ml||Standard Deviation|Mean
1428496|NCT01021748|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which was temporally associated with the use of study drug was also an AE. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 20 months|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1428507|NCT01021683|Secondary|Percentage of Participants With Deferevescence After Administration of Study Treatment|Defervescence was defined as fall of the body temperature below 38.0 degree Celsius (C) at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Percentage of Participants|||Number
1428498|NCT01021748|Secondary|Number of Participants With a Tumor Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Radiological evaluation (via computed tomography [CT] or magnetic resonance imaging [MRI]) of tumor response was assessed every 8 weeks post-treatment during Cycles 1-6, and per institutional standard of care in Cycle 7 and beyond. The best overall tumor response was the best response based on RECIST 1.1 recorded from the start of the study treatment until the end of treatment. Response categories included: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Participants whose tumor was not evaluable (NE) were missing a valid RECIST1.1 measurement at baseline. The best overall tumor response for participants is presented.|Baseline and after every 8 weeks of treatment until documentation of objective response or disease progression (Up to 2 years)|The analysis population consisted of all participants with assessable disease at baseline or measureable disease at baseline per RECIST1.1.|||Participants|||Number
1428499|NCT01021748|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|Adverse events (AEs) were graded using Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. DLTs included: Grade 4 neutropenia lasting for ≥7 days; Grade 3 or Grade 4 neutropenia with fever >38.5ºC and/or infection requiring antibiotic or anti-fungal treatment; Grade 4 thrombocytopenia (≤25.0 x 10^9/L); Grade ≥3 non-hematologic toxicity with exceptions; Any drug-related AE, regardless of CTCAE Grade, leading to a dose modification of MK-2206 or AZD6244; Unresolved CTCAE Grade ≥3 drug-related toxicity requiring drug interruption for >14 days; ≥ Grade 3 signs or symptoms of glucose intolerance and accompanied by ≥ Grade 2 hyperglycemia (glucose >160 dL or 8.9 mmol/L); ≥ Grade 3 electrolyte abnormalities due to glucose intolerance and not attributable to another cause; Diagnosis of lactoacidosis or ketoacidosis; Persistent increases in corrected QT (QTc) interval (>60 msec from baseline and/or >500 msec); Clinically significant bradycardia.|Cycle 1 (Up to 28 days)|The population consisted of all participants who completed ≥ 80% of the first cycle of combination therapy unless interruption of study medication was due to toxicity (e.g. DLT).|||Participants|||Number
1428500|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Breakthrough Fungal Infection|Plasma level of itraconazole was defined as the sum of IC and HIC. A breakthrough fungal infection was defined as any fungal infection that was diagnosed more than (>) 3 days on or during therapy or within 7 days after completion of therapy. Blood cultures were assessed to identify fungus.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.|||ng/mL||Standard Deviation|Mean
1428501|NCT01021683|Secondary|Percentage of Participants With Baseline Fungal Infection|Blood cultures (a laboratory test on a sample of blood) were assessed to identify fungus. Percentage of participants with presence or absence of fungus before starting the study drug were calculated.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Percentage of Participants|||Number
1428502|NCT01021683|Secondary|Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment|Plasma level of itraconazole was defined as the sum of IC and HIC. The OSR was defined based on satisfaction of the following criteria: (1) participants if treated for baseline fungal infection, there was either eradication (removal of fungus in culture), or presumed eradication; no evidence in culture but appeared to be treated clinically, (2) absence of breakthrough fungal infection during the treatment and for 7 days after completing the treatment, (3) survival for 7 days after completing the treatment, (4) absence of early withdrawal due to adverse events or lack of efficacy, and (5) defervescence. The presence and absence of OS was reported.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for given category.|||ng/mL||Standard Deviation|Mean
1428503|NCT01021683|Secondary|Percentage of Participants With Defervescence by Plasma Level of Itraconazole|Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment. Plasma level of itraconazole was defined as the sum of IC and HIC.|Day 5|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'n' signifies participants who were evaluable for this measure at given time points.|||Percentage of Participants|||Number
1428504|NCT01021683|Secondary|Absolute Neutrophil Count (ANC)|The mean values for ANC based on blood tests performed on Day 0 (before starting the study treatment) constitute a Baseline measure for ANC.|Baseline (Day 0)|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Cells/mm^3||Standard Deviation|Mean
1428505|NCT01021683|Secondary|Duration of Neutropenia|The duration of neutropenia was reported. Neutropenia was defined as neutrophil count less than or equal to (<=) 500 cells per cubic millimeter (cells/mm^3), or neutrophil count <=1000 cells/mm^3 and anticipated to decrease to <=500 cells/mm^3 within several days.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Days||Standard Deviation|Mean
1428506|NCT01021683|Secondary|Mean Time to Defervescence in Participants Who Received the Study Treatment|The mean time to defervescence was reported in participants who received the study treatment. Defervescence was defined as fall of the body temperature below 38.0 degree C at least once after starting to receive the study treatment.|Day 0 up to Day 14|The ITT population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||Days||Standard Deviation|Mean
1428508|NCT01021683|Primary|Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment|Percentage of participants who achieved more than or equal to 1000 ng/ml level after administration of study treatment were reported. Plasma level of itraconazole was defined as the sum of itraconazole concentration (IC) and hydroxyitraconazole concentration (HIC).|Day 5|The intent-to-treat (ITT) population included the participants who satisfied the eligibility criteria, received the study drug at least once, and in whom the primary efficacy endpoint was measured at least once.|||Percentage of Participants||95% Confidence Interval|Number
1428509|NCT01021618|Secondary|Myocardial Perfusion Image Quality|Single photon emission computed tomography myocardial perfusion acquisition and image processing was performed in accordance with American Society of Nuclear Cardiology guidelines. All images were interpreted by consensus read of three investigators blinded to stress test protocol and results. Overall perfusion and gated image quality were described as excellent (no artifacts interfering with myocardial perfusion interpretation), good, fair, or poor (artifact requiring reprocessing or repeat imaging of the patient to allow for diagnostic interpretation).|0 hours|Note that images were unavailable in one vasodilator-exercise patient because of urgent catheterization after stress test without imaging and one exercise-vasodilator patient for technical reasons.|||participants|||Number
1428510|NCT01021618|Primary|"Number of Participants With Major Adverse Events or Side Effects Graded Severe on Symptom Questionnaire"|"Number of participants with any side effect (flushing, shortness of breath, headache, chest discomfort, dizziness, nausea, or abdominal pain) requiring specific treatment or graded as severe by the patient; or any death, myocardial infarction, or unplanned hospitalization. Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis."|24 hours|Note that 2 patients allocated to exercise-vasodilator stress did not complete symptom questionnaires and are therefore excluded from analysis.|||participants|||Number
1428511|NCT01021553|Secondary|Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling|The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models.|Up to Week 8|ITT Population. Data was not collected for this outcome measure.||||||
1428512|NCT01021553|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication.|Baseline and up to follow up (post treatment 48 hours)|Safety Population.|||Participants|||Number
1428513|NCT01021553|Secondary|Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone)|Baseline laboratory values were the latest values obtained on or before the participant’s Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1428514|NCT01021553|Secondary|Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry)|Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant’s Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1428515|NCT01021553|Secondary|Mean Change From Baseline in Electrocardiogram (ECG) Values|ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia’s formula (QTc [Fridericia]), QT duration corrected for heart rate by Bazett’s formula (QTc [Bazett]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant’s Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
1428516|NCT01021553|Secondary|Mean Change From Baseline in Heart Rate|Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.|Baseline and up to follow up (post treatment 48 hours)|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1428517|NCT01021553|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position.|Baseline and up to follow up (post treatment 48 hours)|The Safety Population consisted of all participants randomized to study treatment who received at least one dose of study drug. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1428518|NCT01021553|Secondary|Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296|The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population. Only those participants with data available at the indicated time points were analyzed.|||hours||Geometric Coefficient of Variation|Geometric Mean
1428519|NCT01021553|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK557296|The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1428520|NCT01021553|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296|The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded.|At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization|PK Population consisted of all participants from whom a PK sample had been obtained and analyzed. Only those participants with data available at the indicated time points were analyzed.|||Hours times nanograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
1428521|NCT01021553|Secondary|Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included.|Baseline and Week 4|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||minutes||Standard Deviation|Mean
1428522|NCT01021553|Secondary|Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included.|Baseline and up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||minutes||Standard Deviation|Mean
1428523|NCT01021553|Secondary|Mean IELT Compared After the First Dose of Study Drug or Placebo|Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||minutes||Standard Error|Geometric Mean
1428524|NCT01021553|Secondary|Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation|Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||minutes||Standard Error|Geometric Mean
1428536|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
1428699|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 48|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 48|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
1428525|NCT01021553|Primary|Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation|Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).|Up to Week 8|Intent to Treat (ITT) Population consisted of all participants randomized to study treatment. Only those participants with data available at the indicated time points were analyzed.|||minutes||Standard Error|Geometric Mean
1428526|NCT01021423|Secondary|Participants With a Tumor Response|"Number of participants with a measurable tumor at time of randomization who achieve a response. Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.|||participants|||Number
1428527|NCT01021423|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from randomization until the date at which a participant was removed from treatment due to progression, toxicity, refusal or death or received another Non-Hodgkin Lymphoma (NHL) therapy, whichever occurs first.|up to 2 years|Study terminated prematurely. Analysis not conducted.|||months||95% Confidence Interval|Median
1428528|NCT01021423|Secondary|Time to Progression|"Time to progression was defined as the time from the date of randomization until the first date of documented disease progression.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not conducted.|||months||95% Confidence Interval|Median
1428529|NCT01021423|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|"Participants with treatment-emergent adverse events (TEAEs) during the treatment period plus 30 days. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|up to 9 months|Safety population of participants who received at least one dose of study drug|||participants|||Number
1428530|NCT01021423|Secondary|Overall Survival|"Overall survival was defined as the time from randomization to death from any cause.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.|||months||95% Confidence Interval|Median
1428531|NCT01021423|Primary|Progression-free Survival (PFS)|"PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir.~Study terminated prematurely. Analysis not conducted."|up to 7 years|Study terminated prematurely. Analysis not performed.|||months||95% Confidence Interval|Median
1428532|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428533|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
1428534|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
1428535|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
1428546|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428537|NCT01021332|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||participants|||Number
1428538|NCT01021332|Secondary|Number of OAB-q Responders Based on Health-related Quality of Life: Total Score|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||percentage of participants|||Number
1428539|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428540|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428541|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428542|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428543|NCT01021332|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428544|NCT01021332|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used|||units on a scale||Standard Deviation|Mean
1428545|NCT01021332|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1428582|NCT01021007|Primary|EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale|0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 & 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth.|6 weeks||||bleeding sites||Standard Deviation|Mean
1428547|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1428548|NCT01021332|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and up to 52 weeks of FDC treatment|A total of 5 subjects has been excluded from the FAS analysis due to invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1428549|NCT01021332|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1428550|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.|||pads||Standard Deviation|Mean
1428551|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.|||nocturia episodes||Standard Deviation|Mean
1428552|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.|||incontinence episodes||Standard Deviation|Mean
1428553|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.|||urgency incontinence episodes||Standard Deviation|Mean
1428554|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with at least 1 urgency episode at baseline. LOCF imputation was used.|||urgency episodes||Standard Deviation|Mean
1428555|NCT01021332|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||ml||Standard Deviation|Mean
1428556|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||ml||Standard Deviation|Mean
1428557|NCT01021332|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and up to 52 weeks of FDC treatment|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||micturitions||Standard Deviation|Mean
1428583|NCT01021007|Primary|Gingival Index|1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding|6 weeks||||Units on a scale||Standard Deviation|Mean
1428558|NCT01021332|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and up to 52 weeks of FDC treatment|Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
1428559|NCT01021332|Primary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline micturition episode.|||ml/s||Standard Deviation|Mean
1428560|NCT01021332|Primary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseine and one post-baseline micturition episode.|||ml/s||Standard Deviation|Mean
1428561|NCT01021332|Primary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and up to 52 weeks of FDC treatment|SAF population with at least one baseline and one post-baseline PVR volume measured.|||ml||Standard Deviation|Mean
1428562|NCT01021332|Primary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).|From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)|Safety analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period|||participants|||Number
1428563|NCT01021306|Secondary|Bothersomeness of Symptoms|Possible ratings range from 1 (not at all bothersome) to 5 (extremely bothersome)|2 months||||units on a scale||95% Confidence Interval|Mean
1428564|NCT01021306|Secondary|Oral Health Impact Profile (OHIP-14)|The OHIP-14 contains 2 questions about each of 7 dimensions (14 items), indicating how often the participant had experienced each difficulty in the previous month; possible responses range from 0 (never) to 4 (very often). The OHIP score was obtained by summing the 14 ratings.|2 months||||units on a scale||95% Confidence Interval|Mean
1428565|NCT01021306|Primary|Patient-Rated TMD Pain, an 11 Point Numerical Rating Scale (NRS)|The Numerical Rating Scale ranges from 0 (no pain) to 10 (pain as bad as it can be).|2 months||||units on a scale||95% Confidence Interval|Mean
1428566|NCT01021293|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.|During the entire study period (from Day 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1428567|NCT01021293|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1428568|NCT01021293|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.|During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
1428601|NCT01020799|Secondary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline|HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
1428569|NCT01021293|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the Poliorix Group only.|During the 4-day (Days 0–3) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
1428570|NCT01021293|Secondary|Anti-poliovirus Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1428571|NCT01021293|Secondary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.|At Day 0, prior to the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1428572|NCT01021293|Primary|Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).|At Month 3, one month after the third vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
1428573|NCT01021215|Secondary|Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels|Proportion of cases with a post-treatment increase in urinary PGE-M levels by comparing those treated with Zileuton and Celecoxib combined therapy compared to those treated with Zileuton alone. Pre/postchange in levels (Increase) derived from baseline level to Day 6 +/- 1 day. Differences in baseline levels between 2 treatment arms were examined using the Wilcoxon rank-sum test.|Baseline to Day 6|Analysis includes only number of participants in each treatment arm with post-treatment increase in urinary PGE-M levels as measured from baseline.|||proportion of participants|||Number
1428574|NCT01021215|Primary|Median Urinary LTE4 Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary LTE4 levels measured in each treatment arm compared using paired t-test should the data conform to the normality assumption or one-sample Wilcoxon rank-sum test. LTE4 levels reported as median with full range (pg/mg creatinine) for Pre treatment versus Post treatment LTE4 levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and day 6|Seventy-seven subjects completed the entire study, three withdrew for personal reasons. Seven of those participants were excluded from analysis as non-compliant (study medications were undetectable).|||pg/mg creatinine||Full Range|Median
1428575|NCT01021215|Primary|Median Urinary PGE-M Levels (Pre and Post Treatment)|Pre and Post treatment differences in urinary PGE-M levels measured in each treatment arm. PGE-M levels reported as median with full range (ng/mg creatinine) for Pre treatment versus Post treatment PGE-M levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).|Baseline and Day 6|Seventy-seven subjects completed the entire study with seven of those excluded from analysis as non-compliant (study medications were undetectable). Urine of two participants contained interfering substances thus were excluded from PGE-M related analysis.|||ng/mg creatinine||Full Range|Median
1428576|NCT01021111|Secondary|Thigh Coronal Angular Velocity After Feedback Training|How fast the thigh is moving relative to the tibia during the activity, measured in degrees/second.|1 day||||degrees/second||Standard Deviation|Mean
1428577|NCT01021111|Primary|Knee Flexion Angle and Trunk Flexion Angle After Activity Training With Feedback|Knee flexion angle describes the angle between the tibia and femur during the activity. Trunk flexion is the angle between the shoulders and the hips during the activity.|1 day||||degrees||Standard Deviation|Mean
1428578|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Colchicine(fasted)-could not be determined for Subject 25. Colchicine(high-fat meal)-could not be determined for Subjects 22,25, and 28. Colchicine/Probenecid(fasted)-could not be determined for Subject 25.|||pg-hr/mL||Standard Deviation|Mean
1428579|NCT01021020|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose||||pg-hr/mL||Standard Deviation|Mean
1428580|NCT01021020|Primary|Maximal Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose||||pg/mL||Standard Deviation|Mean
1428581|NCT01021007|Primary|Plaque Index (Quigley-Hein Score)|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||Units on a scale||Standard Deviation|Mean
1428829|NCT01018511|Secondary|Tmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||h||Geometric Coefficient of Variation|Geometric Mean
1428584|NCT01020981|Secondary|PTSD Symptoms|"The PCL is a 17-item self-report checklist of PTSD symptoms based closely on the DSM-IV criteria. The PCL-M is a military version and questions refer to a stressful military experience. Total possible scores range from 17 to 85. Higher scores indicate more symptoms of PTSD and a cut-off score of 50 is used for indicating a probable diagnosis of combat-related PTSD."|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|86% of MI NG soldiers who completed surveys returned a complete PCL scale and 87% of IN NG soldiers who completed surveys returned a complete PCL scale.|||units on PCL scale||Standard Deviation|Mean
1428585|NCT01020981|Secondary|Depressive Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Survey was fielded to MIARNG in March 2011 (INARNG in September 2011). Soldiers who did not respond were sent two additional mailings with surveys in April 2011(INANG-October 2011) and May 2011 (INANG-November 2011).|Data were analyzed for those with complete outcome data. Thus, 1 participant in Michigan Army National Guard and 1 participant in Indiana Army National Guard are not included in these results.|||units on a BDI-II scale||Standard Deviation|Mean
1428586|NCT01020981|Primary|Feasibility-response Rate|Response rate of Soldiers to a mailed survey.|Survey was fielded to Michigan National Guard Service Members on three occasions, March 2011, April 2011, and May 2011. The survey was also fielded to Indiana National Guard Service Members on September 2011, October 2011, and November 2011.|"8 or 5% of surveys to Michigan NG Soldiers were not deliverable. 32 (21%) of Indiana NG soldier surveys were not deliverable.~66 of 142 delivered surveys to MI soldiers were returned for a response rate of 46%. 60 of 118 deliverable surveys to Indiana NG Soldiers were returned for a response rate of 51%."|||% of Soldiers returning mailed survey|||Number
1428587|NCT01020903|Primary|Post-operative Nausea and Vomiting|Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.|1 year|"Records for this study are no longer available as they were destroyed in Hurricane Sandy in 10/2012- we do not have any information to use to update the records. The PI for this study is no longer with the institution and no contact information is available. Since we cannot verify the # of participants analyzed, the numbers were changed to 0."||||||
1428588|NCT01020877|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1428589|NCT01020877|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1428590|NCT01020877|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed. One subject had very low plasma metronidazole levels for Period I samples, therefore the data from this subject was dropped from the statistical analysis.|||ng/mL||Standard Deviation|Mean
1428591|NCT01020838|Secondary|Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans|Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans.|90-110 minutes post injection (PET image acquisition)||||Standardized Uptake Value Ratio (SUVR)||Standard Deviation|Mean
1428592|NCT01020838|Secondary|Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.|Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity.|90-110 minutes post injection (PET image acquisition)|Sensitivity and Specificity of the subject level Composite SUVR with three different SOTs.|||percentage of subjects|||Number
1428602|NCT01020799|Secondary|Clinical Global Impression - Severity (CGI-S) Score Change From Baseline|CGI-S assesses global illness severity, i.e. the patient’s current clinical state, on a continuous scale from 1 (“Normal, not ill”) to 7 (“Among the most extremely ill patients”). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
1428603|NCT01020799|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.|HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
1428593|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of β-amyloid according to CERAD Criteria (SOT 3).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification according to CERAD Criteria (SOT 3)."|||percentage of subjects||95% Confidence Interval|Number
1428594|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral neuritic β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining and immunohistochemistry (SOT 2)."|||percentage of subjects||95% Confidence Interval|Number
1428595|NCT01020838|Secondary|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1)."|"Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the whole brain assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of β-amyloid based on Bielschowsky silver staining (SOT 1).~The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was β-amyloid present. The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|"Sensitivity and Specificity of the Majority Read Whole Brain Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining (SOT 1)."|||percentage of subjects||95% Confidence Interval|Number
1428596|NCT01020838|Primary|Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens|"The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of β-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as “normal” or “abnormal” depending on the presence or absence of regional tracer uptake in the respective region. “Normal” therefore meant absence of β-amyloid and “abnormal” presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was β-amyloid present. Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was β-amyloid not present."|90-110 minutes post injection (PET image acquisition)|All participants included in the Interim Analysis Set were included in this analysis.|||percentage of regions|||Number
1428597|NCT01020812|Secondary|Median Progression Free Survival|Time to progression free survival is defined as the time from randomization until either death or progression of disease. The median survival was calculated using a Kaplan Meier algorithm.|18 months||||months||95% Confidence Interval|Median
1428598|NCT01020812|Secondary|To Determine the Overall Survival of TACE and SBRT at 18 Months|Overall survival is defined as the time from the start of treatment until death from any cause.|18 months|All patients who completed treatment|||probability|||Number
1428599|NCT01020812|Secondary|To Determine the Progression-free Survival of TACE and SBRT at 18 Months|Progression free survival is defined as the time from the start of treatment until the first progression or death. Progression will be defined as either local progression, disease occurring elsewhere in the liver, extrahepatic progression or clinical deterioration attributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.|18 months|All patients who completed the treatment|||survival probability at 18 months|||Number
1428600|NCT01020812|Primary|Freedom From Local Progression of TACE and SBRT at 12 Months|Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.|12 months|All patients who completed treatment|||proportion of participants||95% Confidence Interval|Number
1428830|NCT01018511|Secondary|Cminss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428604|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Remission|Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4||||Participants|||Number
1428605|NCT01020799|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS) Response|Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]|Week 4||||Participants|||Number
1428606|NCT01020799|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.|MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]|Baseline, Week 4||||scores on a scale||Standard Error|Least Squares Mean
1428607|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period|"Calculated as percentage of participants who achieved a CR or PR (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants||95% Confidence Interval|Number
1428608|NCT01020786|Secondary|Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period|"Calculated as the percentage of participants who achieved a CR, PR, or SD (confirmed or not). Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants||95% Confidence Interval|Number
1428609|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period|"Percentage of participants who achieved confirmed CR (disappearance of all target lesions), PR (30% decrease in sum of longest diameter of target lesions), or SD (small changes that do not meet above criteria). Response derived from target lesion assessments performed before maintenance therapy (as baseline), during maintenance therapy (as post-baseline), and non-target lesion assessments performed during maintenance therapy according to RECIST guideline version 1.0, defines when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed.|||percentage of participants||95% Confidence Interval|Number
1428610|NCT01020786|Secondary|Overall Survival (OS) During the Maintenance Therapy Period|OS was defined as the duration from the date of the first dose of the maintenance therapy to the date of death from any cause and was calculated by subtracting the induction therapy period from OS. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy. For participants who were alive, OS was censored at the last contact.|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 26.3 months)|Analysis set: Maintenance-treated participants, which consist of the participants who received the maintenance therapy with pemetrexed; 56 participants and 38 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint, PFS, and final endpoint, respectively.|||months||95% Confidence Interval|Median
1428611|NCT01020786|Secondary|Progression Free Survival (PFS) During the Maintenance Therapy Period|"Measured from the date of the first dose of the maintenance therapy. Calculated by subtracting induction therapy period from PFS. Tumor response assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0; define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 24.4 months)|Analysis set: Maintenance-treated participants who received maintenance therapy with pemetrexed; 20 and 12 participants were censored at time of primary endpoint (18 months) and final endpoint. They received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD at cut-off.|||months||95% Confidence Interval|Median
1428659|NCT01020123|Secondary|LDL-C: Mean Ratio|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
1446638|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)||Baseline up to Month 7||||percentage of participants|||Number
1428612|NCT01020786|Secondary|Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR or PR. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable Disease (SD) = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants|||Number
1428613|NCT01020786|Secondary|Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods|"Calculated as the percentage of participants who achieved a confirmed CR, PR, or SD. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. CR = disappearance of all target lesions. PR = 30% decrease in the sum of the longest diameter of target lesions. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions. SD = small changes that do not meet above criteria."|Enrollment to date of progressive disease (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin.|||percentage of participants||95% Confidence Interval|Number
1428614|NCT01020786|Secondary|Overall Survival (OS) During the Induction and Maintenance Therapy Periods|OS was defined as the time from the enrollment date to the date of death from any cause. For participants who were alive, OS was censored at the last contact.|Enrollment to the date of death from any cause (up to 30.8 months)|Full analysis set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 79 participants were censored as the observation period was not enough at the time of data cut-off for the primary endpoint (EP) of PFS. There were 48 participants censored at the final endpoint data cut-off.|||months||95% Confidence Interval|Median
1428615|NCT01020786|Primary|Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods|"PFS defined as time from enrollment date to first date of objective progression of disease or of death from any cause. Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.0, which define when cancer participants improve (respond), stay the same (stabilize), or worsen (progression) during treatments. Participants receiving any subsequent systemic anticancer therapy before objective progression or death were censored at date of last objective progression-free disease assessment before starting subsequent systemic anticancer therapy."|Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months)|Full Analysis Set (FAS): consists of the participants who received the induction combination therapy with pemetrexed and carboplatin; 31 participants were censored as they received subsequent systemic anticancer therapy before confirming objective PD or there was not a confirmed objective PD.|||months||95% Confidence Interval|Median
1428616|NCT01020773|Primary|Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality||13 months||||participants|||Number
1428617|NCT01020747|Primary|The Primary Activity Variable Was the Recurrence of Recurrent Respiratory Papillomatosis (RRP) in Bevacizumab Treated and the Un-treated Vocal Fold in the Same Patient During and at the End of the 6-month Treatment Period.|Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.|6 months|All subjects were analyzed.|||total percentage change||Standard Deviation|Mean
1428618|NCT01020591|Secondary|The Knee Flexion Active Range of Motion, Balance and Pain (VAS)||Jan 2010 to March 2010|||||||
1428619|NCT01020591|Primary|Resistive Index (RI)|Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.|Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day||||ratio||Standard Deviation|Mean
1428620|NCT01020526|Primary|Change From Baseline in Pain Numeric Rating Scale by Week|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement.|Baseline, Weeks 3, 8, 16, 24 and Last Visit.|This population will include all participants who have received at least one dose of study medication.|||Number||Standard Deviation|Mean
1428621|NCT01020474|Secondary|Proportion of Patient Global Impression Change (PGIC) at Week 15|Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.|||percentage of participants|||Number
1428622|NCT01020474|Secondary|Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score.|||percentage of participants|||Number
1446639|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)||Baseline up to Month 7||||percentage of participants|||Number
1428623|NCT01020474|Secondary|Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15|At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score.|||percentage of participants|||Number
1428624|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)|The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score.|||Units on a scale||Standard Error|Least Squares Mean
1428625|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)|Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1428626|NCT01020474|Secondary|Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)|Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).|Baseline to Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1428627|NCT01020474|Secondary|Change From Baseline to Week 15 in Mean Sleep Quality Diary Score|Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates “best possible sleep” and 10 indicates “worst possible sleep”.|Week 15|The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score.|||Units on a scale||Standard Error|Least Squares Mean
1428628|NCT01020474|Primary|Change From Baseline to Week 15 in Mean Pain Diary Score|The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 (“no pain”) and 10 (“worst possible pain”).|Week 15|The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1428629|NCT01020448|Secondary|Safety, Assessed Through the Collection of Adverse Events (AEs)||For the duration of the study (up to month 6)||||participants|||Number
1428630|NCT01020448|Secondary|PSA Level||At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.|||μg/L||Full Range|Median
1428631|NCT01020448|Secondary|Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL)||At month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.|||percentage of participants|||Number
1428632|NCT01020448|Secondary|TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA)|"TMPRSS2-ERG = (TMPRSS2-ERG mRNA / PSA mRNA) x 100000~A TMPRSS2-ERG score <35 was described as 'negative' and a TMPRSS2-ERG score ≥35 as 'positive.'"|At baseline, month 1, 3 and 6 post-treatment|Analysis based on number (N) of patients with a valid value. ITT population.|||participants|||Number
1428633|NCT01020448|Secondary|PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000~Non-assessable = Associated PSA mRNA <7500 copies/mL~≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL~<35 = PCA-3 mRNA above BLQ and less than 35~≥35 = PCA-3 mRNA greater or equal to 35"|At month 1 and 3 post-treatment|Analysis based on number (N) of patients with a valid value. Intention-to-treat (ITT) population.|||participants|||Number
1428634|NCT01020448|Primary|PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA|"PCA-3 score = (mRNA PCA3/mRNA PSA)x1000~Non-assessable = Associated PSA mRNA <7500 copies/mL~≤BLQ = PCA-3 mRNA is below the concentration of the calibrator and associated PSA mRNA >7500 copies/mL~<35 = PCA-3 mRNA above BLQ and less than 35~≥35 = PCA-3 mRNA greater or equal to 35"|At month 6 post-treatment|Number of participants analyzed were 298 as one participant was admitted to an asylum and was withdrawn before month 1 visit was scheduled. No post-baseline assessment was available for this patient.|||participants|||Number
1428635|NCT01020435|Other Pre-specified|Study Duration From Launch Date to Final Outcomes|To assess the feasibility of conducting a full-scale randomized controlled trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage I hypertension. Feasibility measured by and duration of study from launch date to final outcomes.|19 months|51 participants were enrolled; however, the table below shows the number enrolled and consented before the 51 were enrolled. The final row of data shows, 19, signifying the study duration in MONTHS (October 2010 - April 2012).|||months|||Number
1428660|NCT01020123|Secondary|HbA1c ≤ 6.5|Number of Responders ≤ 6.5, FAS Prior to Rescue|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 228 in CSR).|||Participants|||Number
1428661|NCT01020123|Secondary|HbA1c ≤ 7|Number of responders ≤ 7, FAS prior to rescue.|baseline to 4 month|The population is FAS prior to rescue, using the observed cases (see table 35 in CSR).|||Participants|||Number
1428636|NCT01020435|Other Pre-specified|Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study|To assess the feasibility of conducting a full-scale randomized controlled trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage I hypertension. Feasibility measured by: patient recruitment, enrollment, and retention, and duration of study from launch date to final outcomes.|19 months|In this study, participants are not allocated to a treatment arm until they have met all eligibility criteria through the Final Case Review. Because of this it is not possible to report feasibility outcomes by treatment arm.|||# participants|||Number
1428637|NCT01020435|Primary|Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6|"To estimate the effect size and variability of change in systolic (SBP) and/or diastolic blood pressure (DBP) over a six week treatment period to use in planning a full-scale randomized controlled trial and to assess the believability of the placebo manipulation.~The table shows the unadjusted and adjusted mean change in SBP and DBP from baseline to after Treatment 1 (Tx 1), 3 (Wk 3), and 6 (Wk 6) Weeks.~Adjusted values were adjusted for age, sex, BMI, and respective baseline blood pressure.~Wk 3 and Wk 6 DBP were also adjusted for stage of blood pressure (prehypertension or Stage 1 hypertension)."|Baseline after 1, 3, and 6 Weeks of treatment||||mmHg||95% Confidence Interval|Mean
1428638|NCT01020305|Primary|Reduction in Serum PSA|Proportion of subjects with > 50% drop in serum PSA as compared to baseline, assessed at 16 weeks|12 weeks treatment, with primary outcome assessed at 16 weeks||||participants|||Number
1428639|NCT01020123|Secondary|EC50 to Characterise the PD Properties of AZD1656.|The value is model based. The value is independent treatment given.|at 4 month||||nmol/L||Standard Error|Mean
1428640|NCT01020123|Secondary|CL/F to Characterise the PK Properties of AZD1656.|The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.|at 4 month||||L/h||Standard Error|Mean
1428641|NCT01020123|Secondary|Bilirubin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 209 in CSR)|||mg/dL||Standard Deviation|Mean
1428642|NCT01020123|Secondary|Alkaline Phosphatase; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 208 in CSR)|||IU/L||Standard Deviation|Mean
1428643|NCT01020123|Secondary|AST; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 207 in CSR)|||IU/L||Standard Deviation|Mean
1428644|NCT01020123|Secondary|ALT; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 206 in CSR)|||IU/L||Standard Deviation|Mean
1428645|NCT01020123|Secondary|Creatinine; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 211 in CSR)|||IU/L||Standard Deviation|Mean
1428646|NCT01020123|Secondary|Potassium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 214 in CSR)|||mEq/L||Standard Deviation|Mean
1428647|NCT01020123|Secondary|Sodium; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 215 in CSR)|||mEq/L||Standard Deviation|Mean
1428648|NCT01020123|Secondary|Leukocytes; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 198 in CSR)|||*10^3 cells/µL||Standard Deviation|Mean
1428649|NCT01020123|Secondary|Haemoglobin; Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|population is safety analysis set regardless of rescue, using the observed cases (see table 197 in CSR)|||g/dL||Standard Deviation|Mean
1428650|NCT01020123|Secondary|QTcF; Electorcardiagram Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 258 in CSR)|||msec||Standard Deviation|Mean
1428651|NCT01020123|Secondary|Weight, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 244 in CSR)|||kg||Standard Deviation|Mean
1428652|NCT01020123|Secondary|Pulse, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 236 in CSR)|||Beats/min||Standard Deviation|Mean
1428653|NCT01020123|Secondary|Diastolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 240 in CSR)|||mmHg||Standard Deviation|Mean
1428654|NCT01020123|Secondary|Systolic Blood Pressure, Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 237 in CSR)|||mmHg||Standard Deviation|Mean
1428655|NCT01020123|Secondary|C-reactive Protein: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 234 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
1428656|NCT01020123|Secondary|Triglycerides: Change From Baseline|Summary statistic of change from baseline|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 226 in CSR)|||mg/dL||Standard Deviation|Mean
1428657|NCT01020123|Secondary|Total Cholesterol: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 232 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
1428658|NCT01020123|Secondary|HDL-C: Change From Baseline|Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.|baseline to 4 month|The population is safety analysis set regardless of rescue, using the observed cases (see table 230 in CSR)|||ratio||95% Confidence Interval|Geometric Mean
1428662|NCT01020123|Secondary|OGTT/Pro-insulin/Insulin|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 154 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||Ratio||95% Confidence Interval|Geometric Mean
1428663|NCT01020123|Secondary|OGTT/C-peptide|The relative change, FAS prior to rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 150 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||ratio||95% Confidence Interval|Geometric Mean
1428664|NCT01020123|Secondary|OGTT/Insulin|The Relative Change in AUC FAS Prior to Rescue|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 146 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||ratio||95% Confidence Interval|Geometric Mean
1428665|NCT01020123|Secondary|OGTT/Plasma Glucose|The relative change in AUC|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 142 in CSR)The first 50% of patients enrolled in the study were supposed to undertake OGTT, actual number participating was 52%. However, more than 60% of the OGTT patients were excluded from the analyses, as their measurements did not comply with the protocol|||ratio||95% Confidence Interval|Geometric Mean
1428666|NCT01020123|Secondary|SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 31 in CSR)|||mmol/L||95% Confidence Interval|Mean
1428667|NCT01020123|Secondary|FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.|baseline to 4 month|The population is FAS prior to rescue, using the LOCF values (see table 29 in CSR)|||mmol/L||95% Confidence Interval|Mean
1428668|NCT01020123|Primary|HbA1c: Change From Baseline to 4 Month|AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue|Baseline to 4th Month|The population is FAS prior to rescue, using the LOCF values (see table 27 in CSR)|||Percentage||95% Confidence Interval|Mean
1428669|NCT01020019|Primary|21 Days of Consecutive Abstinence as Measured by the Time-line Followback.||reported daily for 12 weeks/ or study participation||||participants|||Number
1428670|NCT01020006|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Clinically meaningful toxicity adverse events will be defined in accordance with by CTCAE v3.0|First dose until 28 days after last dose of PCI-27483 or gemcitabine whichever occurs last in the assigned part (A or B).||||participants|||Number
1428671|NCT01019980|Secondary|The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever||2 hours|||||||
1428672|NCT01019980|Secondary|Safety of Diclofenac Potassium Therapy in the Study Period||6 hours|||||||
1428673|NCT01019980|Secondary|Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours||6 hours|||||||
1428674|NCT01019980|Secondary|Time to Reach a Reduction of Temperature as 0.5 and 1 °C||2 hours|||||||
1428675|NCT01019980|Primary|The Reduction of Temperature||2 hours|||||||
1428676|NCT01019928|Secondary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables(clinical chemistry, haematology and urinalysis parameters)|Pre-entry to follow-up||||Participants|||Number
1428677|NCT01019928|Secondary|Body Temperature|Oral Body Temperature at 1.5 hours post dose|1.5 hours post dose||||degrees Celsius||Standard Deviation|Mean
1428678|NCT01019928|Secondary|QTcF|QT interval corrected for heart rate using Fredericia formula(QTcF) at 1.5 hours post dose|1.5 hours post dose||||ms||Standard Deviation|Mean
1428679|NCT01019928|Secondary|Pulse|Supine Pulse at 1.5 hours post dose|1.5 hours post dose||||beats/min||Standard Deviation|Mean
1428680|NCT01019928|Secondary|DBP|Supine Diastolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose||||mmHg||Standard Deviation|Mean
1428681|NCT01019928|Secondary|SBP|Supine Systolic Blood Pressure at 1.5 hours post dose|1.5 hours post dose||||mmHg||Standard Deviation|Mean
1428682|NCT01019928|Secondary|Tmax|Time of maximum plasma concentration|0 to 4 hours post dose||||hours||Full Range|Median
1428683|NCT01019928|Secondary|Cmax|Maximum plasma concentration|0 to 4 hours post dose||||nmol/L||95% Confidence Interval|Geometric Mean
1428684|NCT01019928|Secondary|AUCt|Area under the plasma concentration curve from time zero to the last quantifiable concentration|0 to 4 hours post dose||||nmol*h/L||95% Confidence Interval|Geometric Mean
1428685|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose||||mA||Full Range|Geometric Mean
1428694|NCT01019707|Primary|Heart Rate|Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.|Timepoints post MA infusion||||BPM|Timepoints|Standard Deviation|Mean
1428831|NCT01018511|Secondary|Cmaxss of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1428686|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose||||mA||Full Range|Geometric Mean
1428687|NCT01019928|Secondary|Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES) and stimulations were performed at approximately 8 cm above the LES. The intensity of the stimuli is increased steadily in steps of 0.5 to 1 mA and the intensity corresponding to the VAS levels 1, 3, 5 and 7 were recorded.~The current will be increased until the patient report moderate pain (VAS 7) or max 80 mA.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose||||mA||Full Range|Geometric Mean
1428688|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose||||ml||Full Range|Geometric Mean
1428689|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose||||ml||Full Range|Geometric Mean
1428690|NCT01019928|Secondary|Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Volume change in the bag was recorded continuously at each level of the visual analogue scale (VAS) and up to VAS7 (Volume at Visual Analogue Scale 7).~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose||||ml||Full Range|Geometric Mean
1428691|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|2.5 hours post dose||||seconds||Full Range|Geometric Mean
1428692|NCT01019928|Secondary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|0.5 hours post dose||||seconds||Full Range|Geometric Mean
1428693|NCT01019928|Primary|Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.|"A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached.~The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring:~= vague perception of mild sensation~= definite perception of mild sensation~= vague perception of moderate sensation~= definite perception of moderate sensation~For painful sensations the patients will use the scale from 5-10 anchored at:~= pain detection~= slight pain~= moderate pain~= medium pain intensity~= intense pain~= unbearable pain"|1.5 hours post dose||||seconds||Full Range|Geometric Mean
1446640|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)||Baseline up to Month 7||||percentage of participants|||Number
1428700|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 36|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 36|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
1428701|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 24|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 24|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
1428702|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 12|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 12|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
1428703|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 3|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 3|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Error|Least Squares Mean
1428704|NCT01019694|Secondary|Mean Number of Puffs of Daily Rescue Medication Use in Two Weeks Prior to Week 0|Mean number of puffs of daily rescue medication use (albuterol use per 24 hour period) in two weeks prior to week 0|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||number of puffs||Standard Deviation|Mean
1428705|NCT01019694|Secondary|Change From Baseline in FVC at Week 48|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428706|NCT01019694|Secondary|Change From Baseline in FVC at Week 24|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428707|NCT01019694|Secondary|Change From Baseline in FVC at Week 12|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428708|NCT01019694|Secondary|Change From Baseline in FVC at Day 1|Change from test-day baseline in Forced Vital Capacity (FVC) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428709|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 48|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 48|baseline, 48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428710|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 24|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 24|baseline, 24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428711|NCT01019694|Secondary|Change From Baseline in FEV1 at Week 12|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose at Week 12|baseline, 12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428712|NCT01019694|Secondary|Change From Baseline in FEV1 at Day 1|Change from test-day baseline in Forced Expiratory Volume in 1 second (FEV1) at 1 hour post dose on test day 1.|baseline, day 1|Treated Set is defined as all patients who were randomized and received study drug|||liters||Standard Error|Least Squares Mean
1428713|NCT01019694|Secondary|Physician's Global Evaluation at Week 48|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428714|NCT01019694|Secondary|Physician's Global Evaluation at Week 36|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428715|NCT01019694|Secondary|Physician's Global Evaluation at Week 24|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428716|NCT01019694|Secondary|Physician's Global Evaluation at Week 12|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428717|NCT01019694|Secondary|Physician's Global Evaluation at Week 3|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428718|NCT01019694|Secondary|Physician's Global Evaluation at Week 0|"Physicians evaluated the patient's overall clinical condition on a scale ranging from poor (score 1 or 2) to excellent (score 7 or 8)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||units on a scale||Standard Deviation|Mean
1428719|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 48|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428720|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 36|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428721|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 24|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428722|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 12|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428723|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 3|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428724|NCT01019694|Secondary|Clinical COPD Questionnaire (CCQ) Symptom Domain Score at Week 0|CCQ symptom domain score assessed patient feelings or limitations due to their COPD on a scale from 0 (not limited) to 6 (totally limited).|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||units on a scale||Standard Deviation|Mean
1428725|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428726|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428727|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428728|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428729|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428730|NCT01019694|Secondary|Overall Satisfaction Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 0|"Patient satisfaction was assessed by asking: Overall, how satisfied are you with your inhaler?. Responses were made on a scale from 1 (very dissatisfied) to 7 (very satisfied)."|0 weeks|Treated Set is defined as all patients who were randomized and received study drug|||units on a scale||Standard Deviation|Mean
1428731|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 36|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|36 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428732|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 24|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|24 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428733|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 12|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|12 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428734|NCT01019694|Secondary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 3|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|3 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428735|NCT01019694|Primary|Performance Domain Score From the Patient Satisfaction and Preference Questionnaire (PASAPQ) at Week 48|Patient acceptability was assessed with the Performance Domain score from the PASAPQ. The score is a mean of 7 items on a scale from 0 (very dissatisfied) to 100 (very satisfied).|48 weeks|Treated Set is defined as all patients who were randomized and received study drug|||unit on a scale||Standard Error|Least Squares Mean
1428736|NCT01019486|Secondary|Myocardial Perfusion Index|Myocardial perfusion indices radionuclide stress and rest images and were obtained from 6 regions within the mid ventricular LV short axis slice. Each was corrected for decay and standardized to a 30 mCi administered dose for each part of a two day study.|1 month||||percentage of Ratio Stress/ rest counts||Standard Deviation|Mean
1428762|NCT01018979|Secondary|Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||mL/kg||Standard Deviation|Mean
1428737|NCT01019486|Secondary|Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.|Regional coronary blood flow reserve (CFR) in a target artery (defined on MPI study) compared to flow in a less diseased atherosclerotic vessel following vasodilator response to intravenously administered regadenoson.|within 6 months|Only 3 individuals met the prescribed perfusion defect on MPI study to proceed to the CFR measurement arm of the study. Therefore numbers were too small for statistical comparison and only mean value and standard deviation of the flow ratio(CFR measurements) are reported..|||CFR ratio||Standard Deviation|Mean
1428738|NCT01019486|Primary|Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.|Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.|1 month|"Determine the MBF obtained from cardiac MRI from 6 regions of the mid-ventricular LV myocardium and a ratio between stress/rest myocardial blood flow ratio. Differences between group were compared using a unpaired t test analyzed for: control(Con) vs T1DM low risk; Con. vs T1DM High Risk; and T1DM low vs high risk."|||percentage of StressMBF/ Rest MBF||Standard Deviation|Mean
1428739|NCT01019369|Secondary|Average Minutes Spent Getting Ready for and Giving the Injection|In total, how much time did the participant spend getting ready for and giving the injection. This includes the time the participant spent getting ready to come to the clinic, getting to the appointment, and waiting for the provider for the control group.|0-12 months|||||||
1428740|NCT01019369|Secondary|Scaled Satisfaction Score|This study was designed to examine if age, parity, partner support, and personal motivation to avoid pregnancy will predict method continuation rates with questionnaires.|6, 12 months|||||||
1428741|NCT01019369|Secondary|Prevalence of Participants With Persistent Skin Changes|The study was designed to examine if using SC DMPA will cause skin changes (dimpling, induration, or atrophy)|12 months|||||||
1428742|NCT01019369|Secondary|Number of Participants Who Would Continue With Self Administration of SC DMPA if it Were Available|The study was designed to examine if self administration of SC DMPA is an acceptable alternative to clinic administration of SC DMPA|6, 12 months|||||||
1428743|NCT01019369|Secondary|Number of Participants Continuing DMPA|The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints.|3, 9, 12 months|115 women w 12 month follow-up data (76 and 39) . 10 participants LTFU in self-administration group, and 7 participants LTFU in the clinic administration group.|||Participants|||Count of Participants
1428744|NCT01019369|Primary|Number of Participants Continuing DMPA at 6 Months|The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA|6 months|"Data was analyzed with the assumption that participants who were lost to follow-up had discontinued DMPA use."|||participants|||Number
1428745|NCT01019317|Primary|Participants With a Complete Response|Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.|Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)|Of participants enrolled, 147 participants received treatment and were evaluable.|||Participants|||Number
1428746|NCT01019252|Primary|Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Parent Report|-Independent blinded evaluator rated parent report of symptom severity (ADHD Rating Scale-IV) to the parent of the adolescent participant. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.|baseline, 4-months, and 8-months|The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).|||units on a scale||Standard Deviation|Mean
1428747|NCT01019252|Primary|Attention Deficit Hyperactivity Disorder (ADHD) Symptom Severity - Clinician Rating|-Independent, blinded evaluator rating of ADHD symptom severity (Clinical Global Impressions - severity scale). The Clinical Global Impression (CGI) Scale is a widely used rating scale to measure overall severity related to ADHD symptoms. The Global Severity rating ranges from; 1=not ill, to 7= extremely ill, with higher scores indicating greater severity.The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.|before randomization, 4-months, 8-months|The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).|||units on a scale||Standard Deviation|Mean
1428763|NCT01018979|Secondary|Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||mL/ hr/kg||Standard Deviation|Mean
1428832|NCT01018511|Secondary|CL/F of Solifenacin||Week 4, Week 8 and Week 12|"PKAS population. N indicates the number of participants with available data at each timepoint."|||L/h||Geometric Coefficient of Variation|Geometric Mean
1428748|NCT01019252|Primary|Changes in Attention Deficit Hyperactivity Disorder (ADHD) Symptoms - Adolescent Report|-Independent blinded evaluator rated adolescent report of symptom severity (Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV). The independent evaluator administered the ADHD rating scale-IV to adolescent participants. This scale, updated for Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV), assesses each of 18 individual symptoms of ADHD using an identical four-point severity grid (0 = not present up to 3 = severe; minimum total score = 0, maximum total score =54, with higher scores indicating greater symptomatology). The CBT for ADHD change score was calculated by combining the data for all participants who received CBT for ADHD (both those who received it between baseline and the 4-month assessment and those who received it between the 4-month and the 8-month assessment). The wait list control score represents only those participants who were in the wait list condition between the baseline and the 4-month assessment points.|before randomization, 4-months, 8-months|The CBT group is comprised of participants originally randomized to receive CBT who completed the intervention (N=21) plus participants initially randomized to the wait-list group who crossed-over to receive CBT and completed the intervention (N=15). The wait list control group is comprised only of those initially assigned to the wait list (N=22).|||units on a scale||Standard Deviation|Mean
1428749|NCT01019135|Secondary|Smoking|Current smoking status|6 months|Participants with available data for current smoking status. Reported values in the table represent number of participants who were current smokers.|||Participants|||Number
1428750|NCT01019135|Secondary|Medication Adherence|The 4-item Morisky Medication Adherence Scale was used, which is scored as yes = 0, no = 1, such that a higher score indicates higher medication adherence. Scores range from 0 to 4, with patients scoring 2 or above considered adherent.|6 months|Participants with available data for medication adherence|||Scores on a scale||Standard Deviation|Mean
1428751|NCT01019135|Secondary|Diet|"The Diet Habit Survey was used to assess diet. It is an inexpensive, reliable, and valid instrument for rapid assessment of eating habits and diet composition. Its 9 questions are related to the consumption of cholesterol, saturated fat, complex carbohydrate (including fiber), and salt.~Greater scores indicate better diets, both for the total score and for each area. The total score indicates the level of fat in the diet (with scores equal to or greater than 236 corresponding to a low-fat diet 20% or less). Scores can begin at 56 and have no upper range."|6 months|Participants with available data for diet|||Scores on a scale||Standard Deviation|Mean
1428752|NCT01019135|Secondary|Self-reported Exercise|"The Godin Leisure-time Exercise Questionnaire will be administered in the pre and post-test surveys. It is a brief and reliable instrument to assess usual leisure-time physical activity behaviour during a one-week period. For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Part two of the questionnaire calculates the frequency of weekly leisure-time activities pursued. Total weekly leisure activity is calculated by summing the products of the separate components. Scores begin at zero, with higher scores indicating greater physical activity. For example, scores equal to or greater than 20 are indicative of someone who is active. There is no max score."|6 months|Participants with available data for self-reported exercise|||Scores on a scale||Standard Deviation|Mean
1428753|NCT01019135|Secondary|Exercise|Mean daily steps as measured by a pedometer over 7 days|6 months|Participants with available data for exercise|||Daily steps||Standard Deviation|Mean
1428754|NCT01019135|Secondary|Exercise Capacity|Exercise capacity as measured by VO2peak on a graded stress test.|6 months|Participants with available data for exercise capacity|||mL/(kg·min)||Standard Deviation|Mean
1428755|NCT01019135|Primary|CR Program Adherence||6 months|Participants with available data for adherence|||percentage of sessions attended||Standard Deviation|Mean
1428756|NCT01018992|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Week 6|Intent to Treat|||participants|||Number
1428757|NCT01018992|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.|||Score on a scale||Standard Deviation|Mean
1428758|NCT01018992|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured has having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6|Intent to treat analysis was performed with missing subjects considered to be non-responders.|||participants|||Number
1428759|NCT01018992|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.|||Score on a scale||Standard Deviation|Mean
1428760|NCT01018979|Secondary|Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion||||cells/μL||Standard Deviation|Mean
1428761|NCT01018979|Secondary|Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||mL/kg||Standard Deviation|Mean
1428764|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr*ng/mL||Standard Deviation|Mean
1428765|NCT01018979|Secondary|The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr*ng/mL||Standard Deviation|Mean
1428766|NCT01018979|Secondary|Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||1/hr||Standard Deviation|Mean
1428767|NCT01018979|Secondary|Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr||Standard Deviation|Mean
1428768|NCT01018979|Secondary|Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||hr||Standard Deviation|Mean
1428769|NCT01018979|Secondary|Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.||Baseline, 3 hours and 6 hours after infusion||||fold||Standard Deviation|Mean
1428770|NCT01018979|Secondary|Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.|Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.|36 hrs after infusion|According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.|||ng/mL||Standard Deviation|Mean
1428771|NCT01018979|Primary|Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).|Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.|1 week|"In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure.~In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure."|||participants|||Number
1428772|NCT01018953|Secondary|Concentration at 2 Hours Postdose (C2 Hours) BIM 23A760 Plasma Levels||At 8 timepoints up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
1428773|NCT01018953|Secondary|Minimum Concentration (Cmin) BIM 23A760 Plasma Levels||At 9 timepoints up to 1 week after 24th administration in week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
1428774|NCT01018953|Secondary|Number of Subjects Reported Adverse Events, Including Any Findings From an Examination of the Injection Site(s)||Up to week 26|Both ITT (Intent-To-Treat) and safety populations were the same analysis group. Treatment emergent adverse events (TEAE) reported by 2 or more patients (safety population) by primary system organ class.|||Participants|||Number
1428775|NCT01018953|Secondary|Change in 5 Hydroxyindoleacetic Acid (5 HIAA) and Chromogranin A||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
1428776|NCT01018953|Secondary|Change in the Quality of Life (QoL) Assessment||Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
1428777|NCT01018953|Secondary|Percentage of Patients With Improvement in Symptoms (Diarrhoea and/or Flushes)||Up to week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
1428778|NCT01018953|Primary|Percentage of Patients With a Positive Overall Satisfactory Relief of Symptoms (Diarrhoea and/or Flushes) on the Likert Scale|Patient satisfaction based on a Likert scale from 0-5 (0 being not satisfied and 5 being completely satisfied)|Week 24|Study was prematurely terminated and no data was collected/analyzed for this outcome measure.||||||
1428779|NCT01018862|Secondary|Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo|change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
1428780|NCT01018862|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
1428781|NCT01018862|Secondary|Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
1428782|NCT01018862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo|Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.|baseline to 28 Days|participant must have had at least one post baseline efficacy assessment|||units on a scale||Standard Deviation|Least Squares Mean
1428783|NCT01018810|Secondary|Number of Participants Who Developed Anti-LY2525623 Antibody Results Through 24 Weeks|Measures anti-LY2525263 antibody as positive or negative. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||participants|||Number
1428784|NCT01018810|Secondary|Pharmacokinetics: Area Under the Time Concentration Curve Through 24 Weeks|Area under the curve of serum drug concentration, including absolute bioavailability. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and in each treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
1428785|NCT01018810|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) at 12 Weeks|A 14-item questionnaire with anxiety and depression subscales; 21 maximum score. Scores of 11+ on either subscale (significant case of psychological morbidity); 8-10 (borderline); 0-7 (normal). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428786|NCT01018810|Secondary|Change From Baseline in the 16-Item Quick Inventory for Depressive Symptomatology-Self Report (QIDS16SRTotal) at 12 Weeks|A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428787|NCT01018810|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at 12 Weeks|10-item, validated questionnaire covers 6 domains. Responses range from 0 (not at all) to 3 (very much); totals range from 0 to 30 (more impairment). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428788|NCT01018810|Secondary|Change From Baseline in the Patient's Global Assessment of Psoriasis Scale at 12 Weeks and 24 Weeks|A scale measures patient perception of psoriatic condition with a continuous range of 0 (good) to 5 (severe). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428789|NCT01018810|Secondary|Change From Baseline in the Visual Analog Scale (VAS) for Psoriatic Arthritis at 12 Weeks and 24 Weeks|A global estimate of pain caused by joint disease on arising made by the subject by placing a vertical mark or tick on a 100-mm VAS from not present to worse, range from 0 to 100mm. Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||millimeters (mm)||Standard Deviation|Mean
1428790|NCT01018810|Secondary|Change From Baseline in Relative Physician's Global Assessment (rPGA) Scale at 12 Weeks and 24 Weeks|The rPGA rates the subject’s psoriasis relative to baseline as 1 (100% clearing), 2 (excellent; 75%-99% clearing), 3 (good; 50%-74% clearing), 4 (fair; 25%-49% clearing), 5 (poor; 0%-24% clearing), or 6 (worsening). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||units on a scale||Standard Deviation|Mean
1428791|NCT01018810|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Scale at Weeks 12 and 24|PASI combines body-surface assessments and severity of desquamation, erythema, and plaque induration/infiltration. Overall score:0(no psoriasis) to 72(severe disease). Percent(%) improvement=(baseline PASI-observed PASI)/baseline PASI*100. Study BDAD was terminated after enrolling only 8 patients. Least Squares (LS) Mean Values were adjusted for time, treatment, and baseline. Given small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline, 12 weeks, 24 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||percentage of units on a scale||95% Confidence Interval|Least Squares Mean
1428833|NCT01018511|Secondary|Area Under the Curve at Steady State (AUCss) of Tamsulosin||Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)|"PKAS population. N indicates the number of participants with available data at each timepoint."|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1428792|NCT01018810|Primary|Percentage of Participants Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Scale by Week 12|PASI combines extent of body-surface involvement assessments in 4 anatomical regions and severity of regional desquamation, erythema, and plaque induration/infiltration. Overall score: 0 (no psoriasis) to 72 (severe disease). Study BDAD was terminated after enrolling only 8 patients. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.|Baseline through 12 weeks|No participants had data analyzed due to the termination of the trial and the insufficient sample size.|||percentage of participants|||Number
1428793|NCT01018732|Secondary|Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination|Local and systemic reactions were solicited to assess safety and tolerability of vaccination|Up to Day 7||||participants|||Number
1428794|NCT01018732|Secondary|Percentage of Subjects With hSBA Seroresponse After Booster Vaccination|For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
1428795|NCT01018732|Secondary|Geometric Mean Ratio After Booster Vaccination|Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1|Day 8 and Day 29 (at 5 Years After Primary Vaccination)|full analysis set|||Geometric mean ratio||95% Confidence Interval|Mean
1428796|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set|||Percentage of participants||95% Confidence Interval|Number
1428797|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.|Day 7, Day 28 post booster (5 years after primary vaccination)|Full Analysis set|||Percentage of participants||95% Confidence Interval|Number
1428798|NCT01018732|Secondary|Geometric Mean Titer at 5 Years After Primary Vaccination|Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set|||Titer||95% Confidence Interval|Geometric Mean
1428799|NCT01018732|Secondary|Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination|Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination )|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
1428800|NCT01018732|Primary|Geometric Mean Titer After Booster Vaccination|Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 8, Day 29 (5 years after primary vaccination)|Full analysis set|||Titer||95% Confidence Interval|Geometric Mean
1428801|NCT01018732|Primary|Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination|Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y|Day 1 (5 years after primary vaccination)|Full analysis set (all subjects who had no major protocol violation as defined prior to database lock).|||Percentage of participants||95% Confidence Interval|Number
1428802|NCT01018680|Other Pre-specified|Percentage of Participants With a Change of Better, Worse, or No Change in Health Outcomes as Measured by Resource Utilization (REU) up to 10 Weeks|"REU captures information regarding the participant’s work status and/or health care utilization. Investigators gather information from medical records, psychiatric history, and direct questioning of the participant and his or her family to complete the questionnaire. Responses to each item, comparing baseline to endpoint, are characterized as Better, Same, or Worse. Better: an increase in time spent working/volunteering/holding a job, decrease in number of health care visits; Same: no change in time spent working/volunteering/holding a job, no change in number of health care visits; Worse: decrease in time spent working/volunteering/holding a job, increase in number of health care visits."|Up to 10 weeks|Intent-to-treat (ITT) participants with a baseline and at least 1 post-baseline REU value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
1428803|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Pulse Rate up to 10 Weeks|Abnormal pulse rate (tachycardia) is defined as a sitting heart rate (HR) ≥ 100 beats per minute (bpm) that is also ≥ 10 bpm compared to baseline, at last visit if highest baseline HR < 100 bpm.|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline pulse rate value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
1428814|NCT01018680|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) at 8 Weeks|The CGI-S scale evaluates the severity of illness at the time of assessment. The scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-S must be administered by a study physician in the presence of the participant or after having been in the presence of the participant. The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline CGI-S value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428804|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) up to 10 Weeks|"Abnormal DPB (diastolic hypertension) is defined as sitting DBP ≥ 90 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline DBP < 90 mm Hg.~Abnormal SBP (systolic hypertension) is defined as sitting SBP ≥ 140 mm Hg that is also ≥ 10 mm Hg increase from baseline that is observed at last visit if highest baseline SBP < 140 mm Hg."|Up to 10 weeks|Participants with a normal baseline and at least 1 post-baseline DBP and SBP value, last-observation-carried forward (LOCF) were included in the analysis. Participants with a normal baseline value and a nonmissing endpoint value for the variable of interest were included in the analysis.|||percentage of participants|||Number
1428805|NCT01018680|Secondary|Percentage of Participants Who Discontinued Due to an Adverse Event During the 10-Week Treatment Period||Baseline through 10 weeks|All randomized participants were included in the analysis.|||percentage of participants|||Number
1428806|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal Weight Gain and Weight Loss up to 10 Weeks|"Abnormal weight gain (potentially clinically significant [PCS] weight gain) is defined as weight gain at last visit ≥ 7% of the baseline weight.~Abnormal weight loss (PCS weight loss) is defined as weight loss at last visit ≥ 7% of the baseline weight."|Up to 10 weeks|Participants with a baseline and at least 1 post-baseline weight value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
1428807|NCT01018680|Other Pre-specified|Percentage of Participants With Abnormal High Hemoglobin A1c (HbA1c) up to 10 Weeks|Abnormal high HbA1c is defined as a post-baseline HbA1c > 6.1% if baseline HbA1c ≤ 6.1% for lab samples obtained before November 17, 2010 and post-baseline HbA1c > 6.4% if baseline HbA1c ≤ 6.4% for lab samples obtained November 17, 2010 and beyond.|Up to 10 weeks|Number of participants with a normal baseline and at least 1 post-baseline abnormal HbA1C value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
1428808|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Brief Pain Inventory-Severity (BPI-S) Average Pain Score up to 8 Weeks|Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for BPI-S average pain rating. The BPI-S self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S average pain value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
1428809|NCT01018680|Secondary|Percentage of Participants Who Achieved a 30 Percent or 50 Percent Reduction in the Weekly Mean of the 24-Hour Average Pain Score up to 8 Weeks|"Response is a dichotomous outcome (Yes/No) indicating at least 30% (or 50%) reduction from baseline to endpoint for the weekly mean of the 24-hour average pain ratings. The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain rating assessed on an 11-point numeric rating scale, with scores from 0 (no pain) to 10 (worst possible pain)."|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean of the 24-hour average pain score value, last-observation-carried forward (LOCF) were included in the analysis.|||percentage of participants|||Number
1428810|NCT01018680|Secondary|Percentage of Responders as Assessed by the Osteoarthritis Research Society International (OARSI) Response Criteria up to 8 Weeks|OARSI response is composite Yes/No response assessed at 8 weeks based on decrease in 24-hour average pain ratings, range: 0 (“no pain”) to 10 (“worst possible pain”), improvement in functioning (using WOMAC physical function scores, range: 0 [no difficulty] to 68 [extreme difficulty]), and improvement in participant's impression of illness (using PGAI scores, range: 0 to 10; 10=greatest severity). OARSI responder=large response in pain or function components (50% relative and 20% absolute improvement), or moderate response (20% relative and 10% absolute improvement) in 2 of 3 components.|Up to 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline OARSI response value, last-observation-carried forward (LOCF) based on values of each of the 3 components listed in the outcome measure description were included in the analysis.|||percentage of responders|||Number
1428811|NCT01018680|Secondary|Percentage of Participants Using Acetaminophen Weekly During the 10-Week Treatment Period|The Least Squares (LS) Mean percentage estimates of participants using acetaminophen was determined during each week individually over the full 10-week treatment period based on participant’s daily Yes/No assessments for the use of acetaminophen. The LS Mean estimates for the main effect of treatment (average weekly use) were adjusted for baseline value, treatment, investigator (pooled), week, and treatment*week.|Baseline through 10 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly acetaminophen use value were included in the analysis.|||percentage of participants||Standard Error|Least Squares Mean
1428812|NCT01018680|Secondary|Change From Baseline in the Profile of Mood States-Brief Form (BPOMS) Total and Subscale Scores at 8 Weeks|30-item BPOMS measures positive and negative aspects of mood states (item score: 0=not at all to 4=extremely). 5 negative factors: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusion-bewilderment; 1 positive factor: vigor-activity. Factor scores range: 0 to 20; high scores=negative mood (positive mood for vigor). Total score=sum of 5 negative factor scores minus vigor score; range: -20=least disturbed to 100=most disturbed. Least Squares Mean estimates adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPOMS value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428813|NCT01018680|Secondary|Change From Baseline in the Patient Global Assessment of Illness (PGAI) at 8 Weeks|The PGAI is a participant-rated measure of the severity of osteoarthritis (OA) of the knee the participant has experienced in the past week as indicated on an 11-point numeric rating scale, with scores ranging from 0 to 10, where greater numbers reflect greater severity. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline PGAI value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428815|NCT01018680|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) Scores at 8 Weeks|Measures pain severity and pain interference with function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Mean interference is the average across the 7 interference items. The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline BPI-S/BPI-I value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428816|NCT01018680|Secondary|Change From Baseline in the Weekly Mean of the 24-Hour Night Pain and Worst Pain Scores at 8 Weeks|Weekly mean 24-hour night pain and worst pain values are calculated from the participant’s daily assessments of pain at night and worst pain during the previous 24 hours on an 11-point numeric rating scale, with scores from 0 (indicating “no pain”) to 10 (indicating “the worst possible pain”). The Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), week, treatment*week, and baseline*week.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline night/worst pain value and at least 1 post-baseline weekly mean 24-hour night/worst pain value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428817|NCT01018680|Secondary|Change From Baseline in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain, Stiffness, and Physical Function Subscale Scores at 8 Weeks|Self-administered questionnaire captures elements of pain, stiffness, and physical disability in participants with osteoarthritis of the knee and/or hip. Index has 24 questions (5 on pain, 2 on stiffness, 17 on physical function). Each question uses a 5-point numeric rating scale ranging from 0 (none) to 4 (extreme). Pain scores range: 0 to 20. Stiffness scores range: 0 to 8. Physical function scores range: 0 to 68. Higher scores=greater impairment. Least Squares Mean estimates were adjusted for baseline value, treatment, investigator (pooled), visit, treatment*visit, and baseline value*visit.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline WOMAC value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428818|NCT01018680|Secondary|Patient Global Impression of Improvement (PGI-I) at 8 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares Mean estimates were adjusted for baseline value of Patient Global Impression of Severity (PGI-S), treatment, investigator (pooled), visit, and treatment*visit. The PGI-S measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).|8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline PGI-S rating and at least 1 post-baseline PGI-I rating were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428819|NCT01018680|Primary|Change From Baseline in the Weekly Mean of the 24-Hour Average Pain Score at 8 Weeks|The weekly mean 24-hour average pain score was calculated from the participant's daily 24-hour average pain ratings using an 11-point numeric rating scale, with scores from 0 (indicating “no pain”) to 10 (indicating “the worst possible pain”). The Least Squares Mean estimates were adjusted for baseline, treatment, investigator (pooled), week, treatment*week, and baseline*week.|Baseline, 8 weeks (blinded endpoint)|Modified intent to treat (mITT) population: ITT participants with a baseline and at least 1 post-baseline weekly mean 24-hour average pain value were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1428820|NCT01020487|Secondary|Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR)|The mean change from Baseline in FMV UACR on a log scale to each post baseline visit.|Baseline and Weeks 4, 8 and 12|Intent-to-treat dataset with available Baseline data, and available data at each time point|||mg/g||Standard Error|Least Squares Mean
1428821|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges|"The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits:~Age 6 – 12: 3.6 – 5.8 mg/dL (1.16 – 1.87 mmol/L); Age 13 – 20: 2.3 – 4.5 mg/dL (0.74 – 1.45 mmol/L)."|Week 12|Intent to treat dataset|||percentage of participants|||Number
1428822|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges|"KDOQI recommends serum calcium is maintained within age appropriate normal ranges:~Age 6 – 12: 9.4 – 10.2 mg/dL (2.35 – 2.55 mmol/L); Age 13 – 20: 8.8 – 10.2 mg/dL (2.20 – 2.55 mmol/L)."|Week 12|Intent to treat dataset|||percentage of participants|||Number
1428823|NCT01020487|Secondary|Part 2: Change From Baseline in iPTH to Each Post-baseline Visit||Baseline and Weeks 2, 4, 8 and 12|Intent to treat dataset with available data at each time point|||pg/mL||Standard Error|Least Squares Mean
1428824|NCT01020487|Secondary|Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges|"The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows::~CKD Stage 3: 35 – 69 pg/mL; CKD Stage 4: 70 – 110 pg/mL."|Week 12|Intent to treat dataset|||percentage of participants|||Number
1428825|NCT01020487|Primary|Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH|The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.|12-week double-blind treatment period|The Intent-To-Treat (ITT) Dataset, defined as the set of all randomized participants who took at least one dose of study drug.|||percentage of participants|||Number
1428826|NCT01020487|Primary|Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)||Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.|All participants enrolled and administered paricalcitol for the PK Portion, Part 1|||ng*hr/mL||Standard Deviation|Mean
1441645|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal||||μg/mL||Standard Deviation|Mean
1428837|NCT01018511|Secondary|Apparent Clearance (CL/F) of Tamsulosin||Week 4, Week 8 and Week 12|"Pharmacokinetics Analysis Set (PKAS)- randomized participants who received at least 1 dose of double-blind study drug and had at least 1 quantifiable plasma concentration of tamsulosin OCAS and/or solifenacin. N indicates the number of participants with available data at each timepoint."|||L/h||Geometric Coefficient of Variation|Geometric Mean
1428838|NCT01018511|Secondary|Change From Baseline to End of Treatment in Average Flow Rate (Qmean)|Qmean during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.|||mL/s||Standard Deviation|Mean
1428839|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)|Qmax during a micturition (urination) was recorded using uroflowmetry.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline micturition episode.|||mL/s||Standard Deviation|Mean
1428840|NCT01018511|Secondary|Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume|PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|SAF population with at least one baseline and one post-baseline PVR volume measured.|||mL||Standard Deviation|Mean
1428841|NCT01018511|Secondary|Number of Participants With Adverse Events (AEs)|Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.|From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)|Safety Analysis Set (SAF) - consisted of participants who received at least one dose of double blind study drug and for whom any data was reported after intake of the first dose of study drug.|||participants|||Number
1428842|NCT01018511|Secondary|Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428843|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: General Health|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428844|NCT01018511|Secondary|Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms|The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428845|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score|Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
1428846|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428847|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428848|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Usual Activities Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428966|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 8|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.||||||
1428849|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Self-care Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428850|NCT01018511|Secondary|Change From Baseline to End of Treatment in EQ-5D Mobility Score|"The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains:~mobility~self-care~usual activity~pain/discomfort~anxiety/depression~Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed)."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||participants|||Number
1428851|NCT01018511|Secondary|Percentage of Participants Who Were OAB-q Responders at End of Treatment|A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.|Week 12 (end of treatment)|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||percentage of participants|||Number
1428852|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Total Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428853|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Social Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428854|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428855|NCT01018511|Secondary|Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428856|NCT01018511|Secondary|Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score|"The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health–related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6:~coping~concern~sleep~social interaction~Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement."|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428857|NCT01018511|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health–related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428858|NCT01018511|Secondary|Change From Baseline to End of Treatment in Individual IPSS Scores|"The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom."|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428859|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS QoL Score|The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428860|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Storage Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428861|NCT01018511|Secondary|Change From Baseline to End of Treatment in IPSS Voiding Score|The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).|Baseline and Week 12|FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428862|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours|The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.|||pads||Standard Error|Least Squares Mean
1428863|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.|||nocturia episodes||Standard Error|Least Squares Mean
1428864|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.|||incontinence episodes||Standard Error|Least Squares Mean
1428865|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1428866|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours|An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population and at least 1 urgency episode at baseline. LOCF imputation was used.|||urgency episodes||Standard Error|Least Squares Mean
1428867|NCT01018511|Secondary|Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||mL||Standard Error|Least Squares Mean
1428868|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition|A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||mL||Standard Error|Least Squares Mean
1428869|NCT01018511|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.|Baseline and Week 12|FAS population with data available at both baseline and end of treatment. LOCF imputation was used.|||micturitions||Standard Error|Least Squares Mean
1428870|NCT01018511|Primary|Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])|"The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale:~0. No urgency;~1. Mild urgency;~2. Moderate urgency;~3. Severe urgency;~4. Urgency incontinence~TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency."|Baseline and Week 12|FAS population. LOCF imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1441646|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||pg/ml||Standard Deviation|Mean
1428871|NCT01018511|Primary|Change From Baseline to End of Treatment in Total International Prostate Symptom Score|"The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms:~Incomplete emptying of the bladder~Intermittency~Weak stream~Hesitancy~Frequency~Urgency~Nocturia~Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic)."|Baseline and Week 12|Full Analysis Set (FAS)-participants who received at least 1 dose of double-blind study drug and had either a total IPSS or TUS at baseline and at least 1 postbaseline total IPSS or TUS. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
1428872|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Moxifloxacin)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia’s adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after dose||||milliseconds||Standard Deviation|Mean
1428873|NCT01018420|Secondary|Electrocardiogram (ECG) Evaluation of the QTcF Interval (Colchicine)|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. It is dependent on heart rate and is corrected (c) to aid interpretation via Fridericia’s adjustment (F), and is reported as QTcF.|24 hours - measured 0.5 hr prior to first dose (baseline), then 1, 3, 6, 7, 8, 10, 12, and 23 hours after first dose||||milliseconds||Standard Deviation|Mean
1428874|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose||||ng-hr/mL||Standard Deviation|Mean
1428875|NCT01018420|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose||||ng-hr/mL||Standard Deviation|Mean
1428876|NCT01018420|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected pre-dose and 1 (prior to second dose), 3 (prior to fourth dose), 6 (prior to final dose), 6.17, 6.33, 6.5, 6.75, 7, 7.25, 7.5, 7.75, 8, 10, 12, 23, 36, 48, 72 and 96 hours post-dose||||ng/mL||Standard Deviation|Mean
1428877|NCT01018394|Primary|Tobacco Abstinence at 12 Weeks|Number of participants who were biochemically confirmed abstinent from tobacco at week 12 using urinary anabasine less than 2 ng per ml.|week 12||||participants|||Number
1428878|NCT01018394|Other Pre-specified|Smokeless Tobacco Reduction Greater or Equal to 50%|Percentage of participants who reduced smokeless tobacco use (cans per week) by 50% or more from baseline|baseline, week 4||||percentage of participants|||Number
1428879|NCT01018264|Secondary|Number of Nocturia Episodes Per 24 Hour Period|To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity|12 weeks||||Number of nocturia episodes per 24 hours||Standard Deviation|Mean
1428880|NCT01018264|Secondary|Parkinson's Disease Quality of Life Scale (PDQOL)|This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life.|12 weeks||||units on a scale||Standard Deviation|Mean
1428881|NCT01018264|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total|To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability).|12 weeks||||units on a scale||Standard Deviation|Mean
1428882|NCT01018264|Secondary|Number of Urinary Incontinence Episodes Per 24 Hour Period|This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity.|12 weeks||||Number of incontinence episodes/24 hours||Standard Deviation|Mean
1428883|NCT01018264|Primary|Number of Micturations Per 24 Hour Period|The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson’s disease (PD) patients as measured by voiding diaries.|12 weeks||||Number of micturations per 24 hours||Standard Deviation|Mean
1428884|NCT01018186|Primary|Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. Holter monitor data were transmitted to a centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||beats per minute||Standard Deviation|Mean
1428885|NCT01018186|Primary|Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data|Twenty-four hour Holter monitors were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart’s rhythm while the monitor is worn. At the end of the 24 hour period, the data from the monitor are downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist.|0-24 hours at Screening, Day 1, Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||beats per minute||Standard Deviation|Mean
1428886|NCT01018186|Primary|Maximum Change From Baseline in the QT Interval Using Bazett’s Correction (QTcB) and QT Interval Using Fridericia’s Correction (QTcF)|The QT interval is an electrocardiogram (ECG) parameter that represents the electrical depolarization and repolarization of the left and right ventricles of the heart. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the ECG. Corrected QT (QTc) is the QT interval corrected for heart rate by using Bazett's formula (QTcB) and Fridericia's formula (QTcF). 12-lead ECG measurements were perfomed at the following scheduled time points: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the value taken pre-dose at screening. The maximum post-Baseline value was derived using all scheduled, unscheduled, and Early Withdrawal ECG assessments. Maximum change from Baseline was calculated as the maximum post-Baseline value minus the value at Baseline.|Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
1428887|NCT01018186|Primary|Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52|Visual acuity is defined as the acuteness or clearness of vision. The minimum angle of resolution (MAR) is the angle a viewed object subtends at the eye, usually stated in degrees/minutes of arc. Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts in decimal numbers. The LogMAR scale is used to express the visual acuity in a linear scale as the logarithm to base 10 of the MAR. A lower score indicates better visual acuity; visual acuity decreases with an increasing score. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
1428888|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52|NO is the opalescence of the nucleus (central layer) of the lens. Per LOC III, NO ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
1428889|NCT01018186|Primary|Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52|NC is the color of the nucleus (central layer) of the lens. Per LOC III, NC ranges from 0.1 (clear or colorless) to 6.9 (very opaque or brunescent). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
1428890|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52|C is defined as the opacification of the cortex (outer layer) of the lens. Per LOC III, C ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
1428891|NCT01018186|Primary|Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52|Funduscopic examination was performed at Baseline, Week 28, and Week 52 to measure the horizontal cup-to-disc ratio of both eyes. The horizontal cup-to-disc ratio is the ratio of the horizontal diameter of the physiological cup to that of the horizontal diameter of the optic disc. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ratio||Standard Deviation|Mean
1428892|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52|Intraocular pressure (IOP) is the fluid pressure inside the eye. IOP was measured twice for each eye at Baseline, Week 28, and Week 52 using Goldmann Applanation tonometry. The second IOP reading was used for analysis. The number of participants with a change from Baseline in IOP of <0 mmHg, >=0 to <4 mmHg, >=4 to <7 mmHg, >=7 to <11 mmHg, and >=11 mmHg are presented. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
1428893|NCT01018186|Primary|Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52|P is defined as the opacification at the back of the lens adjacent to the capsule (or bag) in which the lens sits. An event of P is defined as an increase of >=0.3 from Baseline in LOCS III grade for P in either eye at any time post-Baseline. Per LOC III, P ranges from 0.1 (clear or colorless) to 5.9 (very opaque). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 28, and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
1428894|NCT01018186|Primary|Maximum Change From Baseline in Pulse Rate|Pulse rate was measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20,Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population|||Beats per minute||Standard Deviation|Mean
1428895|NCT01018186|Primary|Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP)|SBP and DBP were measured at the following scheduled time points: Screening, Day 1, Week 2, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36, Week 44, and Week 52/Early Withdrawal. Baseline is defined as the Visit 1 (screening) value. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. Maximum and minimum change from Baseline for any post-Baseline visit was derived using all scheduled, unscheduled, and Early Withdrawal visits.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1428896|NCT01018186|Primary|Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline|A detailed oropharyngeal examination was done at all clinic visits for visual/clinical evidence of oral candidiasis over the entire Treatment Period (worst case any time post-Baseline). For participants with visual/clinical evidence of candidiasis during the Treatment Phase of the study, a culture swab was taken and analyzed for infection.|From Baseline until Visit 11/Early Withdrawal (52 weeks)|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1428897|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 52. The ratio of the Week 52 LSGM to the Baseline LSGM was calculated as the value at Week 52 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 52|UC Population. Only those participants available at the specified time point were analyzed.|||Ratio of LSGM of UCE to Baseline|||Number
1428898|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline|A 24-hour urine sample was collected, and the LSGM for 24-hour UCE was calculated at Baseline and at Week 28. The ratio of the Week 28 LSGM to the Baseline LSGM was calculated as the value at Week 28 divided by the value at Baseline. Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 28|UC Population. Only those participants available at the specified time point were analyzed.|||Ratio of LSGM of UCE to Baseline|||Number
1428899|NCT01018186|Primary|Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline|A 24-hour urine sample was collected, and the least square geometric mean (LSGM) for 24-hour urinary cortisol excretion (UCE) was calculated at Baseline and at Week 12. The ratio of the Week 12 LSGM to the Baseline LSGM was calculated as the value at Week 12 divided by the value at Baseline. Analysis was performed using analysis of covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|Baseline and Week 12|Urinary cortisol (UC) Population: participants in the ITT Population whose urine samples did not have confounding factors that affected the interpretation of results. These participants were determined prior to breaking the blind. Only those participants available at the specified time point were analyzed.|||Ratio of LSGM of UCE to Baseline|||Number
1428900|NCT01018186|Primary|Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion|"A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion (UCE) at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. Any visit post-baseline (AVPB) value was derived using laboratory assessments performed at scheduled, unscheduled, and Early Withdrawal visits. Participants who had a shift from Baseline in their post-Baseline UCE values relative to the normal range, are presented in the To high and To low categories. Participants whose post-Baseline UCE values were unchanged (e.g., High to High) or whose value became normal, are presented in the To normal or no change category. The normal range for UCE is defined as: 11 to 138 nanomoles per 24 hours (nmol/24 hr) for participants >=18 years of age, 8.3 to 151.7 nmol/24 hr for participants 14 to 17 years of age, and 2.8 to 124.2 nmol/24 hr for participants 12 and 13 years of age."|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||participants|||Number
1428901|NCT01018186|Primary|Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hemoglobin values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
1428902|NCT01018186|Primary|Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of hematocrit values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of 1.0||Standard Deviation|Mean
1429727|NCT01012167|Secondary|Laboratory Measures - Glucose|Glucose blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1428903|NCT01018186|Primary|Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected to determine the eosinophil count, total ANC, platelet count, and WBC count at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1428904|NCT01018186|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage||Standard Deviation|Mean
1428905|NCT01018186|Primary|Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of chloride, carbon dioxide (CO2) content/bicarbonate, glucose, potassium, sodium, and urea/BUN values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1428906|NCT01018186|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, and creatinine values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1428907|NCT01018186|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
1428908|NCT01018186|Primary|Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal|Blood samples were collected for the measurement of albumin and total protein values at the following scheduled time points: Baseline, Week 12, Week 28, and Week 52/Early Withdrawal. The Baseline value is defined as the most recent recorded value at Screening or prior to Day 1. Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline.|Baseline; Week 12, Week 28, and Week 52/Early Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (G/L)||Standard Deviation|Mean
1428909|NCT01018186|Primary|Number of Participants With Severe Asthma Exacerbations During the Treatment Period|A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Courses of corticosteroids separated by 1 week or more were treated as separate severe exacerbations.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population|||participants|||Number
1428920|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 4||||units on a scale||Full Range|Mean
1428967|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 4|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.||||||
1428910|NCT01018186|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication|||participants|||Number
1428911|NCT01018134|Secondary|Mean Change From Baseline in %Body Surface Area (%BSA) Affected at Day 28 (or Early Termination).|"Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.~BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared~%Body Surface Area Affected the Rule of Nine was be used."|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.|||percentage of Body Surface Area Affected||Standard Deviation|Mean
1428912|NCT01018134|Secondary|Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28|Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.|||units on a scale||Standard Deviation|Mean
1428913|NCT01018134|Secondary|Mean Change From Baseline in PGA Score at Day 28 Using the ITT|Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.|Day 28|The Intent-to-Treat (ITT) population was used for the secondary endpoint analysis.|||units on a scale||Standard Deviation|Mean
1428914|NCT01018134|Primary|Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).|"The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28.~Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.~A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success."|Day 28|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.|||percentage of Participants|||Number
1428915|NCT01018134|Primary|Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28|"The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)~The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population.~On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1.~A score of 0 = Clear or 1= Almost Clear was considered clinical success.~A patient will be considered a Clinical Failure if: the patient’s PGA score is > 1, the patient was considered to have an insufficient therapeutic response"|28 days|The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.|||percentage of participants|||Number
1428916|NCT01018095|Secondary|TV Culture Positive Result|Participants who returned for their follow up visits were tested for Trichomonas vaginalis using InPouch culture. If parasites are present, it will yield a culture positive result.|3 months post-enrollment|Participants who returned for their 3 mo follow up visit|||participants|||Number
1428917|NCT01018095|Primary|TV Culture Positive Result|At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.|test-of-cure visit at 6-12 days post-treatment completion|Participants who returned for their test of cure visit|||participants|||Number
1428918|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 8||||units on a scale||Full Range|Mean
1428919|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 6||||units on a scale||Full Range|Mean
1446641|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])||Baseline up to Month 7||||percentage of participants|||Number
1428921|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Week 2||||units on a scale||Full Range|Mean
1428922|NCT01018056|Secondary|Expanded Pittsburgh Side Effect Scale Modified to Include Side Effects of Riluzole and D-serine.|The scale consists of 25 items with a score of 0 to 3 per item. 0- none, 1- mild, 2- moderate and 3- severe side effect. The total could be zero (no side effects) to 75 or higher.The scale also allows for the addition of other side effects not included in the original scale and the total score could potentially be higher than 75. If no other side effects outside of the original scale are recorded, the the maximum score remains at 75.|Baseline||||units on a scale||Full Range|Mean
1428923|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Multi-Dimensional Anxiety Scale for Children (MASC)|"Multidimensional Anxiety Scale (MAS): Anxiety will be followed using the Multidimensional Anxiety Scale for Children (MASC), which has been developed by Dr. John March at Duke University and is now considered the preferred instrument for rating anxiety. The MASC asks the patient how they have been thinking and acting recently. It has a maximum possible score of 117 and a minimum score of 0. Higher score on this scale indicates greater severity of anxiety in children.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4.|||units on a scale||Standard Deviation|Mean
1428924|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the Child Depression Inventory - Short Version (CDI-S) Scale|"Depression Inventory-Short Version (DI-S): Depression severity will be rated by using the Depression Inventory-Short Version (DI-S). This 10 item scale takes about 5 minutes to complete. It has excellent psychometric properties and is designed for repeated administrations over time. The maximum possible score of 20, and a minimum score of 0. Higher score on this scale indicates greater severity of depression in children.~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 3). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks|Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3.|||units on a scale||Standard Error|Mean
1428925|NCT01018056|Secondary|The Change From Baseline to 6-week in Scores of the DuPaul Attention Deficit Hyperactivity Disorder Rating Scale.|"DuPaul ADHD Rating Scale: The presence of ADHD symptoms will be assessed using the DSM-IV version of the ADHD rating scale developed by DuPaul. This scale has been normed in large clinical and community samples and has excellent psychometric properties including a test-retest reliability over a 2-week period of 0.93 and significant correlations with direct observations of classroom behavior. The scale has a maximum possible score of 72, and a minimum of 0. The scale ranges from 0 (the best possible outcome) to 70 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6 weeks|Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4.|||units on a scale||Standard Deviation|Mean
1428926|NCT01018056|Secondary|The Change From Baseline to 6-week in Plasma Amino Acid Levels|Blood testing was performed at baseline and at each clinic visit. Data shown below reflects baseline Glutamic Acid minus Week 6 Glutamic Acid, and baseline Serine minus Week 6 Serine levels; as acquired from the blood tests during these respective clinic visits.|Baseline and 6 weeks.||||micromol/L||Standard Deviation|Mean
1428927|NCT01018056|Secondary|Changes in the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) From Baseline to 6-weeks.|"Secondary outcome for obsessive-compulsive behaviors will be measured by changes in the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from baseline to 6-weeks.~The severity of OCD was evaluated using either the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) or Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The (C)Y-BOCS is the most widely used instrument to assess the severity of obsessive-compulsive symptoms in research studies involving children. The (C)Y-BOCS has well established psychometric properties. The scale ranges from 0 (the best possible outcome) to 10 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks||||units on a scale||Standard Error|Mean
1428928|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Patient Global Impression of Improvement (PGI-I).|"Patient Global Impression of Improvement (PGI-I) is a single seven point scale in which the patient/parent is asked to assess the change in overall condition ranging from “very much” improved to “very much worse.”~A score of 1 corresponds to “very much better”; 2 equals “much better;” 3 denotes “a little better”; and 4 represents “no change.” Scores above 4 are used to indicate deterioration, i.e., 5 equals “a little worse;” 6 is “much worse;” and 7 is “very much worse.”~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that only summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)--this applies to all outcome measures reported in the results."|Baseline and 6 weeks||||units on a scale||Standard Error|Mean
1428961|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 4|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 1 (Cycle 1, Day 4)|No participants were analyzed.||||||
1446642|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)||Baseline up to Month 7||||percentage of participants|||Number
1428929|NCT01018056|Secondary|The Change From Baseline to 6-week Score for the Clinical Global Impression –Improvement (CGI-I).|"Clinical Global Impression-Improvement (CGI-I): The CGI-I is used to compare current severity to baseline. A score of 1 corresponds to “very much improved”; 2 equals “much improved;” 3 denotes “minimal change”; and 4 represents “no change.” Scores above 4 are used to indicate deterioration, i.e., 5 equals “minimally worse;” 6 is “much worse;” and 7 is “very much worse.”~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks||||units on a scale||Standard Error|Mean
1428930|NCT01018056|Secondary|The Change From Baseline to 6-week Scores for the Yale Global Tic Severity Scale (YGTSS) Total Score.|"i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50), total maximum score is 100. This scale has established validity, as assessed by Dr. Walkup and colleagues and is considered the best currently available scale to rate the severity of tics. This scale ranges from 0 (the best possible outcome) to 100 (the worst possible outcome).~The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6. Please note that summary data (mean and standard deviation per group) were intended to be reported, and not participant level data (i.e. each individual data point of every subject per group)."|Baseline and 6-weeks||||units on a scale||Standard Deviation|Mean
1428931|NCT01018056|Primary|The Change From Baseline to 6-week Scores for The Total Tic Subscale (TTS)|"The primary outcome measure is effective tic suppression as determined by the difference in the Total Tic subscale (TTS) scores of the Yale Global Tic Severity Scale (YGTSS) at baseline and 6 weeks.~i) Yale Global Tic Severity Scale (YGTSS): The YGTSS is a semi-structured clinical interview designed to measure current tic severity. It is comprised of two parts, a tic score (0-50) and a total impairment score (0-50). The Total Tic Score (TTS: 0-50) has been selected as the primary outcome measure. The scale ranges from 0 (the best possible outcome) to 50 (the worst possible outcome). This scale is considered the best currently available scale to rate the severity of tics. The data provided below represents the mean change (baseline minus six week) for the D-serine group (n = 9), Riluzole (n = 10), and Placebo group (n = 5). For consistency, all values weather positive or negative represent baseline minus week 6."|Baseline and 6-weeks||||units on a scale||Standard Deviation|Mean
1428932|NCT01018030|Secondary|Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)|Participants who required the use of an antibiotic due to the development of FBRS during the 2-week treatment period and the 2-week follow-up period were included in the analysis.|4 weeks|ITT Population|||participants|||Number
1428933|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM postnasal drip score was calculated as the PM postnasal drip score averaged over the entire treatment period minus the PM postnasal drip score over the baseline period (defined as the average PM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428934|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM postnasal drip score was calculated as the AM postnasal drip score averaged over the entire treatment period minus the AM postnasal drip score over the baseline period (defined as the average AM postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428935|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily postnasal drip score was calculated as the daily postnasal drip score averaged over the entire treatment period minus the daily postnasal drip score over the baseline period (defined as the average daily postnasal drip score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428936|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM sinus headache/pressure or facial pain/pressure score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428962|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1|The area under the concentration versus time curve from time 0 to infinity [AUC(0-inf)] is reported during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 1.|||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1441647|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||pg/ml||Standard Deviation|Mean
1428937|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM sinus headache/pressure or facial pain/pressure score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428938|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily sinus headache/pressure or facial pain/pressure score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428939|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM nasal congestion/stuffiness score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428940|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM nasal congestion/stuffiness score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428941|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score|Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily nasal congestion/stuffiness score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428942|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in PM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the evening (PM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in PM MSS was calculated as the PM MSS averaged over the entire treatment period minus the PM MSS over the baseline period (defined as the average PM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428943|NCT01018030|Secondary|Mean Change From Baseline Over the Entire Treatment Period in AM MSS|Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the morning (AM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in AM MSS was calculated as the AM MSS averaged over the entire treatment period minus the AM MSS over the baseline period (defined as the average AM MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Mean
1428944|NCT01018030|Secondary|First Time to Symptom Improvement|Symptom improvement was defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all three major symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) on 2 consecutive 12-hour assessments. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe.|Entire treatment period (up to 2 weeks)|ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||days||Full Range|Median
1428945|NCT01018030|Primary|Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)|The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).|Baseline and entire treatment period (up to 2 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of double-blind study drug. Participants with missing diary data at baseline or post-baseline were not included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1428946|NCT01017952|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1428947|NCT01017952|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
1428948|NCT01017952|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population|||Participants|||Number
1428949|NCT01017952|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
1428950|NCT01017874|Secondary|Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS)|The LCSS data included participant ratings of 6 symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) and 3 summary items (overall symptom severity, interference with daily activities, and overall QoL). Participants recorded their ratings for each item, by placing a mark on a visual analog scale (VAS) that ranged from 0 millimeter (mm) (lower symptom burden, less interference with normal activity, or better QoL) to 100 mm (higher symptom burden, more interference with normal activity, or worse QoL). TWQ was evaluated from date of randomization to first date of worsening, defined as a half standard deviation change as determined from the corresponding baseline item score in the pooled treatment group. For participants not known to have worsened or who were lost to follow-up, TWQ was censored at date of the participant's last LCSS assessment.|Every cycle while on-study therapy and at 3 months post last dose|Participants who received at least 1 dose of study treatment and had LCSS data available. Participants censored (Pemetrexed + Cisplatin + Gefitinib, Gefitinib): Loss of appetite (33,59), Fatigue (42,54), Cough (52,65), Dyspnea (51,66), Hemoptysis (69,74), Pain (48,67), Overall symptoms (52,63), Interference (42,59), Overall QoL (51,51).|||months||Full Range|Median
1428963|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 3|The maximum observed serum concentration of IMC-1121B (ramucirumab) at steady state (Cmax,ss) during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 3.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1428964|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 2|Cmax was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Cycle 2 (predose and 1.25 hours postdose)|No participants were analyzed.||||||
1428965|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1, Day 15|Cmax was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 3 for Cmax during Cycle 1.|Approximately Week 3 (Cycle 1, Day 15)|No participants were analyzed.||||||
1428951|NCT01017874|Secondary|Duration of Tumor Response|The duration of a complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria was defined as the time from first objective status assessment of CR or PR to the first time of objective disease progression or death as a result of any cause. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared. Participants who were not known to have died or had objective progression of disease as of the data-inclusion cut-off date were censored at the date of the participant’s last complete objective progression-free disease assessment prior to that cut-off date.|Date of initial response to the date of measured PD or death up to 34.43 months|A subset of the Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned who had confirmed CR or PR. Pemetrexed + Cisplatin + Gefitinib= 19, Gefitinib= 9.|||months||95% Confidence Interval|Median
1428952|NCT01017874|Secondary|Time to Progressive Disease (TtPD)|TtPD was defined as the time from randomization to the first date of objectively determined progressive disease (PD). For participants who were not known to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, or who had died without objective progression of disease, TtPD was censored at the date of the participant’s last objective progression-free disease assessment prior to cut-off date.|Randomization to the first date of measured PD up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed + Cisplatin + Gefitinib (G) =37, G=26.|||months||95% Confidence Interval|Median
1428953|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR was defined as the percentage of randomized participants with overall response of CR, PR or SD using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all tumor lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and no new lesions having appeared; SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD. PD defined as at least 20% increase in the sum of LD of target, lesions taking as reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions or progression of nontarget lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.|||percentage of participants||95% Confidence Interval|Number
1428954|NCT01017874|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]|TRR was defined as the percentage of randomized participants having a best overall study response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions and the appearance of no new lesions.|Randomization up to 37.52 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned.|||percentage of participants||95% Confidence Interval|Number
1428955|NCT01017874|Secondary|Overall Survival (OS)|OS was the duration from randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date for a particular analysis, OS was censored at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date included adverse event date, lesion assessment date, visit date, and last known alive date).|Randomization up to date of death from any cause up to 57.13 months|ITT population: All data from all randomized participants according to the treatment they were assigned.|||months||95% Confidence Interval|Median
1428956|NCT01017874|Primary|Progression Free Survival (PFS)|PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.|Randomization to the first date of measured PD or death up to 37.32 months|Intent-to-treat (ITT) population: All data from all randomized participants according to the treatment they were assigned. Censored participants: Pemetrexed+Cisplatin+Gefitinib=32, Gefitinib=22.|||months||95% Confidence Interval|Median
1428957|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 3|The area under the concentration versus time curve over the dosing interval at steady state [AUC(tau,ss)] is reported during Cycle 3 (1 cycle=21 days).|Cycle 3 [predose and 1.25 hours (h), 2.25 h, 3.25 h, 4.25 h, 72 h, 168 h, 336 h, and 504 h postdose]|Participants who received a full dose of ramucirumab and have evaluable AUC data during Cycle 3.|||hours*micrograms/milliliter (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1428958|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 2, Day 1|AUC was not calculated due to the sparse pharmacokinetic sampling employed on Cycle 2, Day 1.|Approximately Week 1 (Cycle 2, Day 1)|No participants were analyzed.||||||
1428959|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 15|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 3 (Cycle 1, Day 15)|No participants analyzed.||||||
1428960|NCT01017731|Secondary|Area Under Concentration (AUC) During Cycle 1, Day 8|AUC was summarized once per cycle because participants only received 1 dose of IMC-1121B (ramucirumab) per cycle. Refer to secondary outcome measure 9 for AUC during Cycle 1 (Day 1 through Day 15).|Approximately Week 2 (Cycle 1, Day 8)|No participants were analyzed.||||||
1428968|NCT01017731|Secondary|Maximum Concentration (Cmax) During Cycle 1|Maximum observed concentration of IMC-1121B (ramucirumab) in serum during Cycle 1 (1 cycle=21 days).|Cycle 1 [2.25 hours (h), 3.25 h, 4.25 h, 72 h, 168 h, 336 h postdose]|Participants who received a full dose of ramucirumab and have evaluable Cmax data during Cycle 1.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1428969|NCT01017731|Secondary|Number of Participants With Drug-Related Adverse Events (AEs)|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline up to data cut off (approximately 105.6 weeks)|Safety population: participants who received any quantity of ramucirumab, regardless of their eligibility for the study.|||participants|||Number
1428970|NCT01017731|Primary|Change From Baseline to Cycle 3 in QT/Corrected QT (QTc) Interval Prolongation in Participants|All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is defined as a QTc exceeding 10 milliseconds (msec) with a lower 90% confidence interval (CI) exceeding 5 msec at any postdose time points per the International Conference on Harmonization (ICH) E14 guidelines for non-thorough QT studies (ICH 2005; ICH 2008). Least squares (LS) mean was calculated using a linear mixed model for repeated measures (MMRM) and adjusted for serum concentration.|Baseline, Cycle 3 (1 cycle=21 days)|Participants who received a full study dose of ramucirumab in Cycle 3 and had at least 1 pretreatment ECG and postinfusion ECG at scheduled times as specified in the protocol.|||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
1428971|NCT01017653|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|18 months||||months||95% Confidence Interval|Median
1428972|NCT01017653|Secondary|Objective Response Rate|Number of participants with an objective response (complete response or partial response) based on modified Macdonald criteria. A complete response is defined as the disappearance of all enhancing rumor and mass effect, off all corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. A partial response is defined as greater than or equal to 50% reduction in tumor size on MR (magnetic resonance) / CT(computed tomography) by bi-dimensional measurement on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.|16 months|2 patients' response was unknown due to withdrawal from the study before an MRI was performed.|||participants|||Number
1428973|NCT01017653|Secondary|Relationship Between Epidermal Growth Factor Receptor (EGF-R) Mutational Analysis and Efficacy or Toxicity|Number of participants with an abnormal fluorescence in situ hybridization (FISH) interpretation that 1) survived < 6 months and 2) experienced a ≥ grade 3 toxicity as graded per CTCAE v.3.0|16 months|Insufficient data to analyze the relationship between EGF-R analysis and efficacy or toxicity. Data was not collected for this outcome.|||participants|||Number
1428974|NCT01017653|Secondary|Effect of Panitumumab in Combination With Irinotecan on Corticosteroid Dose|Average change in corticosteroid dose from baseline to the end of cycle 1.|Baseline and Day 29|Insufficient data to analyze the effect of the treatment regimen on corticosteroid dose. Data was not collected for this outcome.|||mg|||Number
1428975|NCT01017653|Secondary|Safety of Panitumumab in Combination With Irinotecan|Number of participants experiencing a toxicity ≥ grade 3 as graded per CTCAE v.3.0|16 months||||participants|||Number
1428976|NCT01017653|Secondary|One-Year Overall Survival|Percentage of participants surviving 12 months from the start of study treatment. OS was defined as the time from the date of study treatment initiation to the date of the death due to any cause.|1 year||||percentage of participants||95% Confidence Interval|Number
1428977|NCT01017653|Primary|6-month Progression-free Survival (PFS)|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), and 3) concomitant steroid use (as reported by the investigator).|6 months||||percentage of participants||95% Confidence Interval|Number
1428978|NCT01017601|Secondary|Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.|Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.|||percentage of participants|||Number
1428979|NCT01017601|Secondary|Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.|Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.|||percentage of participants|||Number
1428980|NCT01017601|Secondary|Change From Baseline to Day 30-59 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.|Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.|||units on a scale||Standard Deviation|Mean
1428981|NCT01017601|Secondary|Change From Baseline to Day 20-29 in the LASA QOL|Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.|Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)|All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.|||units on a scale||Standard Deviation|Mean
1428982|NCT01017601|Secondary|Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.|Up to 23 months|All registered participants who have met eligibility criteria and started the treatment.|||Participants|||Count of Participants
1428983|NCT01017601|Secondary|Duration of Response|Duration of response was defined as the time from the date at which the patient’s earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.|Up to 5 years|All participants with the patient's earliest best objective status was first noted to be a CR or PR.|||months||95% Confidence Interval|Median
1428984|NCT01017601|Secondary|Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all non-nodal target lesions and each target lymph node must have reduction in short axis to <1.0 cm.; Partial Response (PR), at least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the Baseline Sum of Diameters; Overall Response (OR) = CR + PR.|Up to 5 years|All registered participants who have met eligibility criteria and started the treatment.|||percentage of participants|||Number
1428985|NCT01017601|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.|Time from randomization to death or last follow-up (up to 5 years)|All registered participants who have met eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
1428986|NCT01017601|Primary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from randomization to the disease progression or death (up to 5 years)|All registered participants who have met eligibility criteria and started the treatment.|||months||95% Confidence Interval|Median
1428987|NCT01017575|Other Pre-specified|Number of Participants With Grade 3 to 4 Laboratory Abnormalities|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L and Lipase- Grade 3 as 3.1-5.0*ULN, Grade 4 as >5.0*ULN.|From screening up to Week 12 (treatment period)|All treated participants who received at least 1 dose of study therapy.|||Participants|||Number
1428988|NCT01017575|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Baseline up to 30 days after last dose of study drug|All treated participants who received at least 1 dose of study therapy.|||participants|||Number
1428989|NCT01017575|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at both Weeks 4 and 12.|From Week 4 up to Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
1428990|NCT01017575|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24|SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA <15 IU/mL at follow-up Weeks 12 and 24.|Follow up Week 12, Follow up Week 24|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
1428991|NCT01017575|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA <15 IU/mL at Week 12.|Week 12|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
1428992|NCT01017575|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA <15 IU/mL, the lower limit of detection at Week 4.|Week 4|All treated participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
1428993|NCT01017549|Secondary|Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.|Serious adverse device related events reported from treatment through 6 month follow-up and at 1-year follow-up are reported.|Through 6 months|All patients treated were analyzed at 6 months except for 1 patient who was lost to follow-up.|||events|||Number
1428994|NCT01017549|Primary|Number of Participants With Delivery of 34 Gy in 10 Fractions|Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)|measured at end of 10th fraction, usually within 7 days|All patients treated were analyzed|||Participants|||Number
1428995|NCT01017536|Secondary|Mtb-specific T Cell Response in HIV-infected BCG-vaccinated Adult Subjects With no Evidence of TB Disease|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of CD4+ and CD8+ T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with Ag85A, Ag85B, and TB10.4 peptide pools.|Study days 28 and 56|percentage of CD4 or CD8 T-cell response|||percentage of T-cell response||95% Confidence Interval|Median
1428996|NCT01017536|Secondary|Change in HIV Viral Load in HIV-infected, BCG-vaccinated Adult Subjects Before and After Administration of AERAS-402 (From Day 1 to Day 182)||6 months (day 182) post Study Day 0 vaccination.||||Change in copies/mL over time||95% Confidence Interval|Median
1428997|NCT01017536|Primary|CD4+ Lymphocyte Count|Assess the effect of AERAS-402 on the CD4+ lymphocyte count after 6 months in HIV-infected, BCG-vaccinated adult subjects with no evidence of active tuberculosis (TB disease) Change in cells/mm^3 pre-vaccination to Study Day 182|CD4+ counts from samples collected on Study days 0 and 182.||||cells/mm^3||95% Confidence Interval|Median
1428998|NCT01017497|Secondary|Rate of Death Due to Neurologic Causes|The rate of death due to neurologic causes is defined as the percentage of participants whose death is attributable to the progression of neurological disease.|24 months after SRS||||percentage of participants|||Number
1428999|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT) from baseline to 3 months after SRS. The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Change score = score at 3 months after SRS - score at baseline. Negative change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.|||Change in seconds baseline to 3 months||Standard Error|Mean
1429000|NCT01017497|Secondary|Cognition at 3 Months After SRS as Measured by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in MMSE scores from baseline to 3 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The minimum score is 0 and teh maximum score is 30 with higher MMSe scores indicating better cognition. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved cognition.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.|||Change in score from baseline to 3 month||Standard Error|Mean
1429001|NCT01017497|Secondary|Quality of Life at 3 Months After SRS as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline to 3 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score at 3 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|Baseline to 3 months after SRS|Only 24 patients of 49 enrolled completed both the baseline and month 3 questionnaire.|||Change in score from baseline to 3 month||Standard Error|Mean
1429002|NCT01017497|Secondary|Median Overall Survival|Overall survival was defined as the time in months from the start of SRS to the date of death or last contact if alive. Kaplan-Meier methods were used to estimate overall survival.|24 months after SRS||||months||95% Confidence Interval|Median
1429003|NCT01017497|Secondary|12 Month Rate of Distant Brain Metastases|The 12-month rate of distant brain metastases is defined as the percentage of participants with the appearance of new brain metastasis located away from the previously treated lesion (i.e. distant brain failure) 12 months after SRS. Time to the appearance of new brain metastasis was defined as the time between SRS and distant brain failure. Patients without new distant brain metastases as of the last follow-up were censored at the last follow-up date. Kaplan-Meier methods were used to describe the time to distant brain failure.|12 month after SRS|The rate of distant brain metastases is a patient-specific outcome. Of the 49 patients enrolled, six had insufficient post-SRS imaging data to be included in this analysis.|||percentage of participants||95% Confidence Interval|Number
1429004|NCT01017497|Secondary|Rate of Radionecrosis at SRS Treatment Site|The rate of radionecrosis is defined as the proportion of lesions with an indication of radiation-associated changes but no evidence of viable tumor on follow-up imaging (and confirmed by tissue biopsy whenever possible).|24 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.|||proportion of lesions|Participants|95% Confidence Interval|Number
1429016|NCT01017250|Secondary|Performance Status at 2 Months After Stereotactic Radiosurgery (SRS)|"Number of patients with a 10% decline in Karnofsky Performance Status (KPS) from baseline to 2 months after SRS. KPS is rated on a 0 to 100 scale representing a patient's ability to perform normal activity, ability to do active work, and the need for assistance. A score of 100 is perfect health and 0 represents death."|2 months after SRS|Intent to Treat: only 13 out of 15 patients completed month 2 KPS scores|||participants|||Number
1429005|NCT01017497|Primary|12-month Local Control Rate|The 12-month local control rate is the percentage of lesions without recurrence at the lesion site 12 months after SRS. Time to local recurrence was defined as the time between SRS and local recurrence. If local recurrence did not occur, the time to local recurrence was censored at last follow-up (including deaths without local recurrence). Kaplan-Meier methods were used to describe the time to local recurrence.|12 months after SRS|This is a lesion-specific outcome. A patient could have 1 lesion randomized to the 1mm arm and a different lesion randomized to the 3mm arm, the total participants analyzed will not equal 49. Of the 80 lesions, 4 of 40 lesions in the 1-mm arm and 7 of 40 in the 3-mm arm had insufficient post-SRS imaging data to be included in this analysis.|||percentage of lesions|Participants|95% Confidence Interval|Number
1429006|NCT01017263|Primary|Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.|The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.|Baseline to end of study|Study terminated early - no analysis performed on the single subject with data.||||||
1429007|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-6) mm^2/s||Inter-Quartile Range|Median
1429008|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): ADC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Diffusion-weighted imaging, dependent on motion of water molecules, provides information regarding tissue integrity. Apparent diffusion coefficient (ADC) values in the normal brain parenchyma, and those in brain tumors were measured. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-6) mm^2/s||Inter-Quartile Range|Median
1429009|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-1)||Inter-Quartile Range|Median
1429010|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): EVF|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. By measuring extracellular extravascular volume fraction (EVF) it is possible to gain information on brain tissue perfusion. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-1)||Inter-Quartile Range|Median
1429011|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||mmol/kg∙s||Inter-Quartile Range|Median
1429012|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): AUC|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. Area under the curve (AUC) is utilized to measure the signal enhancement ratio washout volume and could be predictive of cancer treatment response. It is possible AUC could be used as a prognostic indicator of the eventual response. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||mmol/kg∙s||Inter-Quartile Range|Median
1429013|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|2 months after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-2) min(-1)||Inter-Quartile Range|Median
1429014|NCT01017250|Secondary|Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): K-trans|DCE-MRI is a quantitative method that allows for non-invasive analysis of tumor vascular characteristics. K-trans is the widely accepted MR method for quantitating brain tumor microvascular permeability( a measure of blood transport.) K-trans will indicate a combination of both flow and permeability properties of tissue. K-trans will indicate the tissue perfusion per unit volume, with a reduction in K-trans suggesting an increased anti-tumor effect and potentially improved outcome. Patients had a DCE-MRI at baseline and at 1 week and 2 months after SRS.|1 week after SRS|Intent-to-treat; only 12 of 15 patients had DCE-MRI results at both time points.|||10(-2) min(-1)||Inter-Quartile Range|Median
1429015|NCT01017250|Secondary|Steroid Usage After Stereotactic Radiosurgery (SRS)|Number of patients using steroids at baseline and at 2 months after SRS.|2 months after SRS 2 months after SRS 2 months after SRS||||participants|||Number
1429035|NCT01017237|Primary|Amnesia: Lack of Picture Recall at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia|Day of surgery prior to discharge|per protocol|||percentage of patients|||Number
1429017|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS) as Measured by the Trail Making Test (TMT)|Cognition as measured by the change in scores on the Trail Making Test (TMT). The TMT consists of two parts. Part A (TMT-A) requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task requirements are similar for Part B (TMT-B) except the person must alternate between numbers and letters (e.g., 1, A, 2, B, 3, C, etc.). The score on each part represents the amount of time required to complete the task. Shorter time scores indicates improved cognition. Change score = score at 2 months after SRS - score at baseline. Negative change scores indicate improved cognition.|2 months after SRS|Intent to treat: only 14 of 15 patients completed the month 2 questionnaire|||seconds||Standard Error|Mean
1429018|NCT01017250|Secondary|Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline to 2 months after SRS. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score at 2 months after SRS - score at baseline. Higher scores for this scale indicate improved quality of life(QOL). Positive change scores indicate improved cognition.|2 months after SRS|Intent to Treat: only 14 patients out of 15 completed the month 2 questionnaire|||units on a scale||Standard Error|Mean
1429019|NCT01017250|Secondary|Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS)|Quality of life as measured by the change in Functional Assessment of Cancer Therapy-Brain (FACT-Br) scores from baseline to 2 months after SRS. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Higher scores for all scales indicate improved quality of life (QOL).Change score = score at 2 months after SRS - score at baseline. Positive change scores indicate improved quality of life.|2 months after SRS|Intent to Treat; only 10 patients out of 15 completed the month 2 questionnaire.|||units on a scale||Standard Error|Mean
1429020|NCT01017250|Secondary|Overall Survival(OS)|Time in months from the start of stereotactic radiosurgery (SRS) to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|2 years|Intent to treat|||months||95% Confidence Interval|Median
1429021|NCT01017250|Secondary|Radiographic Response at Month 2|Radiographic response at 2 months after stereotactic radiosurgery (SRS) assessed by MRI and based on modified Response Assessment in Neuro-Oncology (RANO) criteria.Per RANO, complete response (CR) is the disappearance of all target lesions;Partial Response(PR)is a >=30% decrease in the sum of the longest diameter of target lesions.|2 months after SRS|Intent to treat|||Participants|||Number
1429022|NCT01017250|Secondary|Progression-free Survival (PFS)|Time in months from the start of stereotactic radiosurgery (SRS) to the date of first progression according to Revised Assessment in Neuro-Oncology (RANO)criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Per RANO, progression is defined as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in a non-target lesion or the appearance of new lesions.|1 year|Intent to treat|||months||95% Confidence Interval|Median
1429023|NCT01017250|Primary|Central Nervous System (CNS) Toxicity|"Number of participants who experience Grade 3 or higher adverse events in the Nervous System Disorder domain of Common Toxicity Criteria for Adverse Events (CTCAE) v4.0."|2 months after Stereotactic Radiosurgery|The number of participants with CNS toxicity is reported.|||participants|||Number
1429024|NCT01017237|Secondary|Bispectral Index Score (BIS)|Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state.|During surgery duration.|per protocol|||units on a scale||Standard Deviation|Mean
1429025|NCT01017237|Secondary|Ramsey Sedation Scale Score|Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive|During surgical procedure|per protocol|||units on a scale||Standard Deviation|Mean
1429026|NCT01017237|Secondary|Patient Satisfaction With Sedation Technique|Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied|after completion of surgery (within 15 minutes)|per protocol|||units on a scale||Standard Deviation|Mean
1429027|NCT01017237|Secondary|Surgeon Satisfaction With Sedation Technique|Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5)|After surgery completed: day of surgery, within 15 minutes|per protocol|||units on a scale||Standard Deviation|Mean
1429028|NCT01017237|Secondary|Heart Rate|Per EKG monitor|Duration of surgery|per protocol|||Beats per minute||Standard Deviation|Mean
1429029|NCT01017237|Secondary|Heart Rate|Heart rate per EKG monitor|Prior to sedation|per protocol|||Beats per minute||Standard Deviation|Mean
1429030|NCT01017237|Secondary|Mean Arterial Blood Pressure|Measured using automated blood pressure monitor|During duration of surgery|per protocol|||mmHg||Standard Deviation|Mean
1429031|NCT01017237|Secondary|Mean Arterial Blood Pressure|Blood pressure per automated monitor|Immediately prior to surgery|per protocol|||mmHg||Standard Deviation|Mean
1429032|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured by capnography at nares|Duration of surgery|per protocol|||mmHg||Standard Deviation|Mean
1429033|NCT01017237|Secondary|Respiratory Parameters: End-tidal Carbon Dioxide|Measured via capnography at nares|Immediately prior to sedation|per protocol|||mmHg||Standard Deviation|Mean
1429034|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time.|Lack of recall of picture shown indicates presence of amnesia on day following surgery.|One day after surgery|per protocol|||percentage of patients|||Number
1446643|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)||Baseline up to Month 7||||percentage of participants|||Number
1429040|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam.|Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery.|One day after surgery|per protocol|||percentage of patients|||Number
1429041|NCT01017237|Primary|Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam.|Percentage of patients unable to recall picture|Day of Surgery prior to discharge|Per protocol|||percentage of patients|||Number
1429042|NCT01017237|Primary|Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation.|Lack of recall of picture shown indicates presence of amnesia the day following surgery.|One day after surgery|Per protocol|||percentage of patients|||Number
1429043|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pulse oximetry|During surgical procedure|per protocol|||Percent oxyhemoglobin saturation||Standard Deviation|Mean
1429044|NCT01017237|Secondary|Respiratory Parameters: Oxyhemoglobin Saturation|Oxyhemoglobin saturation per pule oximeter|Immediately prior to surgery|per protocol|||Percent oxyhemoglobin saturation||Standard Deviation|Mean
1429045|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Rate of respirations|During surgical procedure|per protocol|||Breaths per Minute||Standard Deviation|Mean
1429046|NCT01017237|Secondary|Respiratory Parameters: Respiratory Rate|Respirations per minute|Immediately prior to sedation|Randomized per protocol|||Breaths per Minute||Standard Deviation|Mean
1429047|NCT01017237|Primary|Amnesia: Lack of Picture Recall Shown Prior to Sedation.|Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery|Day of surgery prior to discharge|Randomized per protocol|||percentage of participants|||Number
1429048|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429049|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429050|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429051|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness: skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of drying reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429052|NCT01017146|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study|||participants|||Number
1429053|NCT01017146|Secondary|Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-6=small effect on the participant’s life; 7-12=moderate effect on the participant’s life; 13-18=very large effect on the participant’s life; 19-30=extremely large effect on the participant’s life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.|||scores on a scale||Standard Deviation|Mean
1429073|NCT01017120|Secondary|Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12|A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||nodule count||Standard Deviation|Mean
1441648|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||pg/ml||Standard Deviation|Mean
1429054|NCT01017146|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-5=small effect on the participant’s life; 6-10=moderate effect on the participant’s life; 11-20=very large effect on the participant’s life; 21-30=extremely large effect on the participant’s life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at the respective week.|||Scores on a scale||Standard Deviation|Mean
1429055|NCT01017146|Secondary|Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set|||participants|||Number
1429056|NCT01017146|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
1429057|NCT01017146|Secondary|Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set|||participants|||Number
1429058|NCT01017146|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.|||days||95% Confidence Interval|Median
1429059|NCT01017146|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.|||lesion counts||Standard Deviation|Mean
1429060|NCT01017146|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.|||percent change||Standard Deviation|Mean
1429061|NCT01017146|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
1429062|NCT01017146|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set|||participants|||Number
1429074|NCT01017120|Secondary|Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12|A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||pustule count||Standard Deviation|Mean
1429148|NCT01016678|Primary|Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose|All data was collected and measured from self-reported patient diaries|3 years|Patients who treated with study drug and were pain free at 2 hours and then continued to be pain free through 24 hours|||percentage of attacks|Participants||Number
1429063|NCT01017146|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.|||lesion counts||Standard Deviation|Mean
1429064|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants|Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429065|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants|Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429066|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator|Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429067|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator|Dryness=skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of dryness reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants|||participants|||Number
1429068|NCT01017120|Secondary|Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator|Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.|Baseline (Week 0/Day 1) to Week 12|All Randomized Participants: all participants who were randomized in the study|||participants|||Number
1429069|NCT01017120|Secondary|Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger|The CDLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-6=small effect on the participant’s life; 7-12=moderate effect on the participant’s life; 13-18=very large effect on the participant’s life; 19-30=extremely large effect on the participant’s life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Week 2, 4, 8, and 12|ITT Analysis Set: only those participants 16 years of age or younger and whose CDLQI scores were calculated at Baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.|||scores on a scale||Standard Deviation|Mean
1429070|NCT01017120|Secondary|Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older|The DLQI was used to measure how much the participants’ skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant’s life; 2-5=small effect on the participant’s life; 6-10=moderate effect on the participant’s life; 11-20=very large effect on the participant’s life; 21-30=extremely large effect on the participant’s life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set: only those participants 17 years of age or older and whose DLQI scores were calculated at baseline and at Weeks 2, 4, 8, or 12 were evaluated for change in DLQI score at respective week.|||scores on a scale||Standard Deviation|Mean
1429071|NCT01017120|Secondary|Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12|A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||closed comedone count||Standard Deviation|Mean
1429072|NCT01017120|Secondary|Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12|An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||open comedone count||Standard Deviation|Mean
1429728|NCT01012167|Secondary|Laboratory Measures - VLDL|Very low density lipoprotein (VLDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1429075|NCT01017120|Secondary|Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12|A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||papule count||Standard Deviation|Mean
1429076|NCT01017120|Secondary|Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set|||participants|||Number
1429077|NCT01017120|Secondary|Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12|An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.|Weeks 2, 4, 8, and 12|ITT Analysis Set|||participants|||Number
1429078|NCT01017120|Secondary|Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Weeks 2, 4, and 8|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
1429079|NCT01017120|Secondary|Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set|||participants|||Number
1429080|NCT01017120|Secondary|Time to a 50 Percent Reduction in Total Lesion Counts (TLC)|Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.|Baseline (Week 0/Day 1) to Week 12|ITT Analysis Set: only those participants with a >=50 percent reduction from Baseline in TLC were evaluated.|||days||95% Confidence Interval|Median
1429081|NCT01017120|Secondary|Absolute Change From Baseline in LC at Weeks 2, 4, and 8|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.|Baseline (Week 0/Day 1); Weeks 2, 4, and 8|ITT Analysis Set. Calculation was based on the LOCF imputation method for missing data.|||lesion counts||Standard Deviation|Mean
1429082|NCT01017120|Secondary|Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12|LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.|Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12|ITT Analysis Set. The LOCF imputation method was used for missing data.|||percentage change||Standard Deviation|Mean
1429083|NCT01017120|Primary|Number of Participants With an ISGA Score of 0 or 1 at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Week 12|ITT Analysis Set. Missing values were imputed using the LOCF method.|||participants|||Number
1429084|NCT01017120|Primary|Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12|Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.|Baseline (Week 0/Day 1) and Week 12|ITT Analysis Set|||participants|||Number
1429120|NCT01016912|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .|At Week 4 on treatment|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1429085|NCT01017120|Primary|Absolute Change in Lesion Counts (LCs) From Baseline to Week 12|LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.|Baseline (Week 0/Day 1) and Week 12|Intent-to-Treat (ITT) Analysis Set: all randomized participants who were dispensed study product. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data, in which missing final values of the outcome variable are replaced by the last known value before the participant was lost to follow up.|||lesion counts||Standard Deviation|Mean
1429086|NCT01017042|Primary|Area Under The Concentration Time Curve From Zero Through Infinity (AUC∞)|"The area under the plasma concentration versus time curve extrapolated to infinity.~AUC∞ is calculated as the sum of Total AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant"|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).||||pg-hr/ml||Standard Deviation|Mean
1429087|NCT01017042|Primary|Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (96 Hours) (AUC 0-t)|The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration (96hours), calculated by the linear trapezoidal rule.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).||||pg-hr/ml||Standard Deviation|Mean
1429088|NCT01017042|Secondary|Electrocardiogram Corrected QT Interval (QTcF)|Corrected QT interval by Fridericia’s formula -Measured at baseline, 0.5, 1, 2, and 4 hours|Measured at baseline, 0.5, 1, 2, and 4 hours|All participants|||Milliseconds||Standard Deviation|Mean
1429089|NCT01017042|Primary|Maximum Plasma Concentration|The maximum or peak concentration that the drug reaches in the plasma.|Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).||||picograms/ml||Standard Deviation|Mean
1429090|NCT01017029|Secondary|Participants With at Least One Occurrence of Composite Treatment Failure Events|Comparison of 6-months cumulative incidence of composite treatment failure events (BPAR ≥ 2R, rejection with hemodynamic compromise, graft loss, or death) between delayed everolimus arm and immediate everolimus arm|6 months||||participants||95% Confidence Interval|Number
1429091|NCT01017029|Secondary|Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group|CMV infection is defined as pp65 antigenemia or DNAemia|6 months|safety population|||participants||95% Confidence Interval|Number
1429092|NCT01017029|Secondary|Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group|LDL = low density lipoprotein|6 months|safety population|||participants||95% Confidence Interval|Number
1429093|NCT01017029|Secondary|Hazard Cox’s Model Analysis of Pericardial/Pleural Effusions|Pericardial effusions: any pericardial effusion defined as at least moderate (i.e. measuring at least 2.0 cm in diastole, in the point of largest distance between the pericardial leaflets), with or without signs of hemodynamic compromise, or leading to drainage or to prolonged hospitalization. Pleural effusions: need for surgical drainage tubes for longer than 7 days after surgery and subsequent pleural effusions leading to drainage. CI = confidence interval, HR = hazard ratio, MDRD = Modification of Diet in Renal Disease|6 months|safety population|||participants|||Number
1429094|NCT01017029|Secondary|Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group||6 months|safety population|||participants|Participants|95% Confidence Interval|Number
1429095|NCT01017029|Primary|Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group|Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm|6 months|safety population|||participants||95% Confidence Interval|Number
1429096|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|by protocol|||pg-h/ml||Standard Deviation|Mean
1429097|NCT01017003|Primary|Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.|Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.|0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing|by protocol|||pg-h/ml||Standard Deviation|Mean
1429098|NCT01017003|Primary|Maximum Serum Concentration (Cmax)|maximum serum concentration measured after a single oral dose in fasted healthy adults and after a single oral dose in fasted healthy adults at steady state for comparison of the two conditions|Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing|per protocol|||pg/mL||Standard Deviation|Mean
1429099|NCT01016977|Secondary|Overall Satisfaction With Study Product at Week 12|"Overall satisfaction with the study product was assessed from a participant's answer to the following question on the product acceptability and preference questionnaire at the end of study (i.e., Week 12): What is your overall satisfaction with the study product. Participants assessed overall satisfaction with the study product in the morning and evening, based on a 6-point scale: 1, very satisfied; 2, satisfied; 3, neutral (no opinion); 4, unsatisfied; 5, very unsatisfied."|Week 12|ITT Population|||units on a scale||Standard Deviation|Mean
1429147|NCT01016678|Primary|Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention|All data was collected and measured from self-reported patient diaries|3 years|94 subjects treated at least one migraine attack with active drug or placebo were analyzed while only 74 subjects had the potential to take placebo during one of their 4 migraine attacks|||percentage of attacks|Participants||Number
1429100|NCT01016977|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of 12 question scores; total score ranges from 12 to 60.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
1429101|NCT01016977|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of 10 question scores; total score ranges from 10 to 50.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
1429102|NCT01016977|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of 7 question scores; total score ranges from 7 to 35.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
1429103|NCT01016977|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 12|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 12|ITT Population. Participants with missing baseline values were not included in this analysis. No sunscreen or moisturizer data were collected; thus, there was no analysis of these data.|||units on a scale||Standard Deviation|Mean
1429104|NCT01016977|Secondary|Mean Change From Baseline in Total Lesion Count at Weeks 1, 2, 4, 8, and 12|The investigator will count inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population|||lesions||Standard Deviation|Mean
1429105|NCT01016977|Secondary|Mean Change From Baseline in Inflammatory and Non-inflammatory Lesion Counts at Weeks 1, 2, 4, 8, and 12|Inflammation is defined as a localized protective reaction of tissue to irritation, injury, or infection, characterized by pain, redness, swelling, and sometimes loss of function. The investigator counted inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on a participant's face at each study visit. The face is defined as the hairline edge to the mandibular line and should include the forehead, cheeks, and chin. W, Week.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population|||lesions||Standard Deviation|Mean
1429106|NCT01016977|Secondary|Number of Participants With at Least a Two-grade Improvement in ISGA Score From Baseline to Week 12|The investigator conducted the overall assessment of the participant’s facial acne vulgaris based on the Investigator's Static Global Assessment Scale (ISGA). The ISGA is a 6-point scale: 0, clear skin with no acne vulgaris; 1, almost clear skin; 2, mild; 3, moderate; 4, severe; 5, very severe.|Baseline and Week 12|ITT Population|||participants|||Number
1429107|NCT01016977|Primary|Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Skin comfort was assessed by participants based on 5-point scale: +2, very comfortable; +1, comfortable; 0, neutral; -1, somewhat uncomfortable; or -2, uncomfortable.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
1429108|NCT01016977|Primary|Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Oiliness was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
1429121|NCT01016912|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.|At Weeks 4 and 12 on treatment|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1429109|NCT01016977|Primary|Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 6, 8, and 12 minus the value at baseline. Itching was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
1429110|NCT01016977|Primary|Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Burning/stinging was assessed by participants based on a 6-point scale: 0=none: normal, no discomfort; 1=trace: awareness, no discomfort, no intervention required; 2=mild: noticeable discomfort, intermittent awareness; 3=moderate: noticeable discomfort, continuous awareness; 4=marked: definite discomfort, continuous awareness, interferes occasionally with normal daily activities; 5=severe: definite continuous discomfort, interferes with normal daily activities.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
1429111|NCT01016977|Primary|Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Peeling was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
1429112|NCT01016977|Primary|Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Dryness was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|ITT Population. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
1429113|NCT01016977|Primary|Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12|Mean change from baseline was calculated as the average value at Weeks 1, 2, 4, 8, and 12 minus the value at baseline. Erythema (redness of the skin, due to increased blood flow in the capillaries in the lower layers of theh skin) was assessed by the investigator based on a 6-point scale: 0=none, which is normal; 1=trace, which is mild and localized; 2=mild, which is mild and diffuse; 3=moderate, which is moderate and diffuse; 4=marked, which is moderate and dense; 5=severe, which is prominent and dense.|Baseline and Weeks 1, 2, 4, 8, and 12|Intent-to-Treat (ITT) Population: all randomized participants who received study product. Some participants did not return for all visits; thus, data were not captured for all participants in the ITT Population at all visits.|||units on a scale||Standard Deviation|Mean
1429114|NCT01016964|Primary|Change in Hair Count at 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks||||hairs per cm^2||Standard Deviation|Mean
1429115|NCT01016938|Secondary|Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation|The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.|2 years||||participants|||Number
1429116|NCT01016938|Primary|Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors|"Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm.~The participants’ tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI."|2 years||||participants|||Number
1429117|NCT01016912|Secondary|Percentage of Participants With Virologic Failure|Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.|From on-treatment Week 1 to Follow-up Week 24|All participants who received at least 1 dose of study therapy.|||percentage of participants|||Number
1429118|NCT01016912|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24|SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .|Follow-up Weeks 4, 12, and 24|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1429119|NCT01016912|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory|At Week 12 on treatment|All participants who received at least 1 dose of study therapy.|||percentage of participants||80% Confidence Interval|Number
1429122|NCT01016912|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.|||participants|||Number
1429123|NCT01016912|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From baseline to 30 days after last dose of study drug|All participants who received at least 1 dose of study therapy.|||participants|||Number
1429124|NCT01016873|Secondary|Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52||Week 52||||CNV as % of Lesion||Standard Deviation|Mean
1429125|NCT01016873|Secondary|Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.||Week 12, 28, and 104||||Number of Injections||Standard Deviation|Mean
1429126|NCT01016873|Secondary|Time From Mandatory Injection at Day 0 to the First PRN Injection.||52 Weeks||||Weeks||95% Confidence Interval|Median
1429127|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"|||Percentage of Patients|||Number
1429128|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"|||Proportion of Patients|||Number
1429129|NCT01016873|Secondary|Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)||Weeks 12, 28 and 52.|"Number of Participants Analyzed:~Week 12: n = 73, 71, 78~Week 28: n = 73, 73, 77~Week 52: n = 74, 72, 79"|||Percentage of Patients|||Number
1429130|NCT01016873|Secondary|Change in Mean Visual Acuity (VA)||Weeks 12, 28, 52 and 104.||||Letters||Standard Deviation|Mean
1429131|NCT01016873|Primary|Number of Lucentis® Injections Up To And Including Week 52||During the first 52 weeks.||||Injections||Standard Deviation|Mean
1429132|NCT01016847|Secondary|Sputum Cell Counts and Differentials||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
1429133|NCT01016847|Secondary|Asthma Exacerbation|Asthma exacerbation is defined as the development of an increase in asthma symptoms which results in an increase in the use of asthma medications (typically inhaled corticosteroids and/or parenteral corticosteroids) or the addition of another new asthma medication or antibiotics.|Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
1429134|NCT01016847|Secondary|Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
1429135|NCT01016847|Secondary|Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
1429136|NCT01016847|Secondary|Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
1429137|NCT01016847|Primary|Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.||Baseline/randomization to week 16|Due to insufficient accrual, data analysis was not performed.||||||
1429138|NCT01016834|Secondary|Treatment Confidence|Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.|After 4 migraines or 60 days||||participants|||Number
1429139|NCT01016834|Secondary|Treatment Preference|Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).|After 4 migraines or 60 days||||participants|||Number
1429140|NCT01016834|Primary|Overall Satisfaction|"Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c Overall satisfaction was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)"|After 4 migraines or 60 days|The Per-protocol (PP) population included all subjects who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures.|||Scale of 0-100; 100= very satisfied||Standard Deviation|Mean
1429141|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 5||Day 4 to Day 5|||||||
1429142|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 4||Baseline to Day 4|||||||
1429143|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 3||Baseline to Day 3|||||||
1429144|NCT01016691|Secondary|Mean Change in Intraocular Pressure at Day 2||Baseline to Day 2|||||||
1429145|NCT01016691|Primary|Mean Change in Intraocular Pressure at Day 1||Baseline to Day 1|per-protocol population|||mmHg||Standard Deviation|Mean
1429146|NCT01016678|Secondary|To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.|Collected from patient reported paper diaries|3 years|This analysis data was not collected.||||||
1429149|NCT01016678|Primary|Number of Participants With 2-hour Pain Free Active Study Drug|All data was collected and measured from self-reported patient diaries|3 years|The number of subjects randomized to treatment was 104, which included 94 subjects who treated at least one migraine with study drug and were included in the safety and efficacy data analysis|||Participants|||Number
1429150|NCT01016652|Secondary|Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper|Utility of the use of the Binocular +/-1.00D accommodative flipper as a screening tool for those emerging presbyopia subjects|Baseline|Analysis was on those subjects who were randomized to either treatment arm with the intent to treat.|||percentage of participants|||Number
1429151|NCT01016652|Secondary|Comfortable Wearing Time|Comfortable wearing time was measured using self-reported subject awareness of irritation at a given time of day, rounded to the nearest half-hour. Could be described as aware of issue or completely comfortable.|week 4|Analysis was on those subjects randomized to either arm with the intent to treat.|||hours||Inter-Quartile Range|Median
1429152|NCT01016652|Secondary|Subject Reported Lens Comfort Using CLUE Questionnaire|Subject reported lens comfort was assessed using the CLUE Questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range from 0 -120.|week 4|Analysis was on those subjects enrolled and randomized to either one of the arms with intent to treat.|||units on a scale||Inter-Quartile Range|Median
1429153|NCT01016652|Secondary|Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ|Proportion of subjects reporting frequent/constant near vision problem per the Near Vision Questionnaire (NVQ). The NVQ was used to assess subjects' near vision problems. Subjects graded each question using a 5-level Likert-type scale (5-levels: never, infrequent, sometimes, frequently, constantly).|week 4|The NV Questionnaire was administered to those enrolled in the study and randomized to either treatment arm.|||percentage of participants|||Number
1429154|NCT01016652|Primary|Monocular Amplitude of Accommodation|The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.|week 4|Analysis was on those who were randomized to either treatment arm with intent to treat. One eye was chosen.|||diopters||Inter-Quartile Range|Median
1429155|NCT01016652|Primary|Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire|The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.|week 4|Analysis was on those subjects enrolled, randomized into one of two randomized arms, and who completed the study.|||units on a scale||Inter-Quartile Range|Median
1429156|NCT01016600|Primary|Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age|"Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment.~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul."|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|Participants in Cohort 1, 2, and 3 were not analyzed for this outcome as it is a Phase II outcome measure only. (3) participants in Phase II cohort were not evaluable for response because they did not complete cycle 1.|||percentage of participants|||Number
1429157|NCT01016600|Secondary|Toxicity Profile (Grade 3/4 Toxicities)|AML ≥18 years or untreated AML ≥60 years|30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))||||participants|||Number
1429158|NCT01016600|Secondary|Duration of CR for Complete Responders||Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(6) participants in Cohort 1, (3) participants in Cohort 2, (4) participants in Cohort 3, and (10) participants in Phase II did not have a complete response and are not evaluable for this outcome.|||months||Full Range|Median
1429159|NCT01016600|Secondary|Relapse Free Survival (RFS)|This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))||||months||Full Range|Median
1429160|NCT01016600|Secondary|Time to Progression (TTP)|Defined as the interval from the date of the first dose of study drug to the date of progressive disease.|Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))|(2) cohort 1 participants were not evaluable for this outcome measure because (1) was removed for DLT & (1) withdrew from study. (2) phase II participants were not evaluable because both were removed from study in the first cycle for adverse events.|||months||Full Range|Median
1429161|NCT01016600|Secondary|Event Free Survival|Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))||||months||Full Range|Median
1429162|NCT01016600|Secondary|Overall Survival|Defined as the date of first dose of study drug to the date of death from any cause.|Until death - median follow-up 4.6 months (full range (0.3-31.4 months))||||months||Full Range|Median
1429163|NCT01016600|Secondary|Partial Remission Rate (PR)|Requires that the criteria for complete remission be met with the following exceptions: decrease of >50% in the percentage of blasts to 5-25% in the BM aspirate. A value of < 5% blasts in BM with Auer rods is also considered a partial remission.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
1446644|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])||Baseline up to Month 7||||percentage of participants|||Number
1429164|NCT01016600|Secondary|CR With Incomplete Blood Counts Rate|Defined as CR with the exception of neutropenia <1000/uL or thrombocytopenia <100,000/ul.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
1429165|NCT01016600|Secondary|Cytogenetic CR (CRc) Rate|Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
1429166|NCT01016600|Secondary|Morphologic Complete Remission Rate (CRm)|Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1000/uL, platelet count > 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.|Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
1429167|NCT01016600|Secondary|Morphologic Leukemia-free State|Defined as < 5% blasts on the BM aspirate with spicules and a count of >200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.|||participants|||Number
1429168|NCT01016600|Secondary|Response Rate (CRm + CRc + CRi + PR)|"Response rate (CRm + CRc + CRi + PR)~CRm = morphologic complete remission~CRc = cytogenetic complete remission~CRi = morphologic complete remission with incomplete blood count recovery~PR = partial remission"|Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]|(3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response. (1) participant in Cohort one had both CRm and CRc.|||participants|||Number
1429169|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.~Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.~Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)||||mg/m^2|||Number
1429170|NCT01016600|Primary|Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.~Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for > 60 days from the start of a chemotherapy cycle.~Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy."|Completion of the phase I portion of study (approximately 1 year and 4 months)|(1) participant in Cohort 1 did not start treatment. The Phase II cohort was not analyzed because this was a Phase I outcome only.|||dose-limiting toxicities|||Number
1429171|NCT01016483|Secondary|Phase II: Volume of Central Compartment (V1/f) and Volume of Peripheral Compartment (V2/f) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.||||||
1429172|NCT01016483|Secondary|Phase II: Clearance From Central Compartment (CL/f) and Intercompartmental Clearance (Q/f) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.||||||
1429173|NCT01016483|Secondary|Phase II: Absorption Rate Constant (ka) of Pimasertib (MSC1936369B)||Baseline, every 8 weeks up to EOT (6 years)|As per change in planned analysis, there was reduction of PK investigations for the phase II part of the trial, removal of PK sampling for gemcitabine and its metabolites and replacement of intense sampling with a sparse sampling scheme for pimasertib, thus the outcome measure was not analyzed.||||||
1429174|NCT01016483|Secondary|Phase II: Overall Survival (OS) Time|Overall survival (OS) time is defined as the time (in months) from randomization to death.|Baseline, every 8 weeks up to EOT (6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||months||95% Confidence Interval|Median
1429175|NCT01016483|Secondary|Phase II: Time to Progression (TTP)|Time to progression (TTP) is defined as the time (in months) from the randomization date to the date of progression prior to the start of any subsequent therapy for the primary disease, as reported and documented by the Investigator (i.e. radiological progression per RECIST).|From randomization every 8 weeks up to EOT (6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||months||95% Confidence Interval|Median
1429729|NCT01012167|Secondary|Laboratory Measures - Triglycerides|Triglyceride blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1429176|NCT01016483|Secondary|Phase II: Percentage of Subjects With Clinical Benefit|Clinical Benefit was defined as the presence of at least one CR, PR or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||percentage of subjects|||Number
1429177|NCT01016483|Secondary|Phase II: Percentage of Subjects With Best Overall Response (BOR)|Best overall response was defined as the presence of at least one complete response (CR), partial response (PR) or Stable Disease (SD) (using RECIST v1.0) during treatment. CR: Disappearance of all target lesions, PR: At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline and SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Baseline, every 8 weeks up to end of treatment (EOT i.e. 6 years)|ITT analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||percentage of subjects|||Number
1429178|NCT01016483|Secondary|Phase II: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.|From the first dose of study drug administration until EOT (6 years)|SAF for the Phase II included all subjects who had received at least 1 administration of the trial medication Gemcitabine or Placebo if the subject is in the gemcitabine + Placebo treatment arm (Arm 1) and MSC1936369B or gemcitabine in the MSC1936369B + gemcitabine treatment arm (Arm 2).|||subjects|||Number
1429179|NCT01016483|Secondary|Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 2|ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.|pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1|"Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here n signifies those subjects who were evaluable at the specified time point for each arm respectively."|||Fluorescence Intensity||Standard Deviation|Mean
1429180|NCT01016483|Secondary|Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e. gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
1429181|NCT01016483|Secondary|Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
1429182|NCT01016483|Secondary|Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 2|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
1429183|NCT01016483|Secondary|Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||Liter per hour (L/H)||Geometric Coefficient of Variation|Geometric Mean
1429184|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
1429185|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1.Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
1429186|NCT01016483|Secondary|Safety Run-In Part: Area Under Curve (AUC:0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) Regimen 2|AUC:0 to infinity is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1429187|NCT01016483|Secondary|Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 2||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1429188|NCT01016483|Secondary|Safety Run-In Part: Levels of Pharmacodynamic (Pd) Markers (Phosphorylated- Extracellular Signal-Regulated Kinase (ERK) in Peripheral Blood Mononuclear Cells [PBMCs]): Regimen 1|ERK phosphoprotein in peripheral blood monocytes (PBMCs) was analyzed from blood samples of all subjects in the SAF analysis set (safety-run part) only.|pre-dose on Day 1, 2, 22 of Cycle 1; post-dose on Day 1, 22 of Cycle 1|"Pharmacodynamic population included SAF analysis set for the safety run-in part include all subjects who received at least 1 (non-zero) administration of the trial medication (pimasertib or gemcitabine). Here n signifies those subjects who were evaluable at the specified time point for each arm, respectively."|||Fluorescence Intensity||Standard Deviation|Mean
1429189|NCT01016483|Secondary|Safety Run-In Part: Apparent Volume of Distribution (V) of Gemcitabine: Regimen 1|Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
1429190|NCT01016483|Secondary|Safety Run-In Part: Oral Volume of Distribution (V/f) of Pimasertib (MSC1936369B): Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||liter||Geometric Coefficient of Variation|Geometric Mean
1429191|NCT01016483|Secondary|Safety Run-In Part: Total Clearance (CL) of Gemcitabine: Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|"PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here n signifies those subjects who were evaluable at the specified time point."|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
1429192|NCT01016483|Secondary|Safety Run-In Part: Apparent Oral Clearance (CL/f) of Pimasertib (MSC1936369B): Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) was influenced by the fraction of the dose absorbed.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1429193|NCT01016483|Secondary|Safety Run-In Part: Area Under Curve (AUC: 0 to Infinity) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1|AUC:0 to infinity was a measure of the serum concentration of the drug over time. It was used to characterize drug absorption.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1 of Cycle 1 for MSC1936369B, 0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1 for Gemcitabine|PKS of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1429411|NCT01014442|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 90 post-transplantation|ITT Population (total 64 participants). Here, Number of participants analyzed = participants evaluable for this outcome measure.|||L||Standard Deviation|Mean
1429194|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Apparent Terminal Half-Life (t1/2) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1|Plasma decay half-life was the time measured for the plasma concentration to decrease by one half.|0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
1429195|NCT01016483|Secondary|Safety Run-In Part: Time to Reach Maximum Concentration (Tmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU): Regimen 1||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|PKS set of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day 1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||hours||Full Range|Median
1429196|NCT01016483|Secondary|Safety Run-In Part: Maximum Concentration (Cmax) of Pimasertib (MSC1936369B), Gemcitabine (dFdC), and Gemcitabine Inactive Metabolite 2',2'-Difluorodeoxyuridine (dFdU) for Regimen 1||0 hour (pre-dose), 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24 (post-dose) on Day 1, 22 of Cycle 1|Pharmacokinetic set (PKS) of the safety run in part included subjects who had received at least the first dose of both drugs (i.e., gemcitabine and pimasertib), and provided PK samples as per the protocol for at least 24 hours following first dosing on Day1. Here “n” signifies number of subjects evaluable for each category at specified time point.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1429197|NCT01016483|Secondary|Safety Run-In Part: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was any untoward medical occurrence in a subjects who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) except AEs recorded with an onset date prior to the first day of drug administration unless a worsening of the event was recorded after the first dosing date, in which case the event was counted as a TEAE. TEAEs include both SAEs and non-SAEs.|From the first dose of study drug administration until EOT (6 years)|Safety analysis set (SAF) for the safety run-in part included all subjects who had received at least 1 administration of the trial medication (pimasertib or gemcitabine).|||subjects|||Number
1429198|NCT01016483|Primary|Phase II: Progression-Free Survival (PFS) Time|PFS was defined as the time from randomization to the first documentation of objective tumor progression (Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline, Progressive Disease (PD): At least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started, or the appearance of 1 or more new lesions and stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started) or to death due to any cause, whichever occurred first. PFS calculated as (Months) = Date of first PD or death or censoring date minus date of randomization plus 1) divided by 30.4375.|From the time of randomization to every 8 weeks up to end of treatment (EOT) (6 years)|Intent to Treat (ITT) analysis set included all subjects who had been randomized for the phase II part, as per the interactive voice response system (IVRS).|||months||95% Confidence Interval|Median
1429199|NCT01016483|Primary|Safety Run-In Part: Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 asymptomatic increases in liver function tests reversible within 7 days. Grade 3 vomiting encountered despite adequate therapy. Grade 3 diarrhea encountered despite adequate anti diarrhea therapy. Grade 4 neutropenia greater (>) 5 days duration or febrile neutropenia lasting for more than 1 day. Grade 4 thrombocytopenia > 1 day/Grade 3 with bleeding. Grade 4 anemia: Any treatment delay > 2 weeks due to drug-related adverse effects.|Up to 28 days in Cycle 1|DLT analysis set included all subjects of safety run-in part who received any dose of pimasertib on at least 18 out of 20/25 out of 28 of the planned days on pimasertib & least 3 gemcitabine weekly infusions during first 28 days of treatment or experienced DLT during the 28 first days of treatment regardless of the amount of each drug received.|||subjects|||Number
1429200|NCT01016353|Primary|Number of Participants With Primary Fascial Closure||Up to 30 days||||Participants|||Count of Participants
1429201|NCT01016132|Primary|Overall Preference|"Overall preference when comparing study lenses to habitual lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer Habitual Lenses; Strongly Prefer Habitual Lenses."|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||Participants|||Number
1429213|NCT01015833|Secondary|Time to Progression (TTP)|Time to Progression (TTP) is defined as the time from on study to progression. Progression is defined by the RECIST criteria as Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Median and 95% confidence intervals are provided for each arm below.|Up to 3 years||||months||95% Confidence Interval|Median
1429202|NCT01016106|Primary|Heterozygous for Filaggrin (FLG) Null Mutations|Buccal swab samples were obtained from each subject. Deoxyribonucleic acid (DNA) was purified from buccal swabs (IsoHelix Swabs, BocaScientific, Boca Raton, FL) and quantified by ultraviolet spectrophotometry. Purified genomic DNA and controls were amplified by polymerase chain reaction (PCR) from three different regions of FLG exon 3 with three primer sets. PCR products were analyzed by electrophoresis, purified (Qiaquick, Qiagen, Valencia, CA), and subjected to duplicate cycle sequencing reactions using ABI BigDye v3.1 reagents (Applied Biosystems, Carlsbad, CA). Labeled sequencing products were purified for capillary electrophoresis (ABI3730 or ABI3130 sequencer with POP7 polymer), and sequence results were examined using ABI SeqScape software. All nucleotide changes were noted, including 30 single nucleotide polymorphism (SNPs) in the population tested, the most common of which were coding changes at T454A, H2507Q, and G2545R, and silent change at nucleotide t2508c.|1 month||||participants|||Number
1429203|NCT01016067|Secondary|"Number of Subjects Having Additional Surgical Procedure Classified as a Treatment Failure"|Subject who had a surgery after the original study treatment was classified as a treatment “failure” if the additional surgery or treatment occurred in the involved limb and affected the study treatment and/or its mechanism of action in relation to the diagnosis or condition of the subject that was the cause for having the original study treatment.|12 months||||participants|||Number
1429204|NCT01016067|Secondary|Success in Short Form 36-Item (SF-36) Health Survey|SF-36 was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). Success was defined as any improvement in a subject’s SF-36 PCS post-operatively as compared to the pre-operative condition.|12 months||||participants|||Number
1429205|NCT01016067|Secondary|Success in Short Musculoskeletal Functional Assessment (SMFA)|The SMFA is an assessment tool that measures a subject’s overall function for a broad range of musculoskeletal injuries and disorders. The SMFA results were summarized into two components, the dysfunctional index and the bother index. Success for the SMFA assessment was defined as any improvement post-operatively as compared to the pre-operative condition.|12 months||||participants|||Number
1429206|NCT01016067|Secondary|Success of Pain Status at the Delayed Healing Site|After walking five or six steps, subjects rated their intensity of pain/discomfort at the delayed healing site using a numerical rating scale from 0-10, with a score of 0 representing “no pain” and a score of 10 representing “pain as bad as it could be”. Subjects who were unable or declined to walk because of severe leg pain were considered to have a score of 10. Success for pain at the delayed healing site was defined as at least a 2-point improvement in pain from the pre-operative score. Success of pain status at the delayed healing site was a component of overall success.|12 months||||participants|||Number
1429207|NCT01016067|Secondary|Success in Weight Bearing Ability|Success in weight bearing ability (a component of overall success) was defined that subject was able to bear weight without severe pain on the affected limb. The subject was asked to stand, bearing full weight on the affected limb in a single-leg stance without ambulatory assistance for 10 seconds. If the subject was able to do so without severe pain, a positive (success) response was recorded. If the subject was either unable to stand on the affected limb in a single-leg stance or declined to do so because of limb weakness, poor balance, or severe leg pain, a negative (failure) response was documented.|12 months||||participants|||Number
1429208|NCT01016067|Secondary|Radiographic Union Success|Radiographic union success (a component of overall success) was defined as complete disappearance of fracture lines or the presence of bridging bone across the delayed healing site as observed on at least three of the four cortices (anterior, posterior, medial, and lateral), using plain films. If there was more than one delayed healing fracture line, all fracture lines must have been united in order to be considered a successful fracture union.|12 months||||participants|||Number
1429209|NCT01016067|Primary|Overall Success|Overall success is reported as participants who met all of the following criteria: 1. radiographic union success; 2. success in weight bearing ability; 3. improvement in pain at the delayed healing site; 4. no serious adverse event classified as “implant-associated” or “implant/surgical procedure-associated” (device-related); 5.no additional surgical procedures classified as a failure.|12 Months|"Ten investigational and 9 control subjects were evaluable for overall success while only 9 investigational and 8 control subjects completed the study at 12-month follow-up. Two subjects were classified as failure due to related serious adverse event or additional surgery before completion of the study."|||participants|||Number
1429210|NCT01016015|Primary|Progression-free Survival Rate, Defined as CR + PR + SD, as Assessed by RECIST Criteria|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks|From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks||||participants|||Number
1429211|NCT01015976|Primary|AUC Post Surgery (n =5) Compared to AUC Control (n=5)|AUC of surgery group compared to the AUC of control group|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours|Per protocol|||ng-hr/mL||Standard Deviation|Mean
1429212|NCT01015833|Secondary|Best Overall Response Rate|Best Overall Response Rate is defined as is the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|Up to 3 years|Patients who started treatment and had follow-up assessments were included in this analysis.|||percentage of patients|||Number
1429384|NCT01014741|Primary|Number of Participants With 1 Year Freedom From AF / AT|Freedom from atrial arrhythmia after repeat procedures with or without drugs|one year|Ninety-two patients in the ibutilide group and 93 patients in the placebo group remained in AF after study drug administration and underwent CFAE ablation.|||participants|||Number
1429214|NCT01015833|Secondary|Progression Free Survival|Progression free survival is defined as the time from study entry to earliest date of disease progression. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of one or more new lesions is also considered progression).|Up to 3 years||||months||95% Confidence Interval|Median
1429215|NCT01015833|Secondary|Incidence of Toxicities, as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.|Up to 3 years||||percentage of patients|||Number
1429216|NCT01015833|Primary|Overall Survival|Overall survival is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.|Up to 3 years||||month||95% Confidence Interval|Median
1429217|NCT01015820|Primary|Mean Blood Vessel Radius (BVR)|BVR serves as a marker for early increase of blood supply (EIBS).|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.|||cm||95% Confidence Interval|Mean
1429218|NCT01015820|Primary|Deoxyhemoglobin Concentration (DHb)|Deoxygenated hemoglobin is the form of hemoglobin without the bound oxygen. It serves as a marker for early increase of blood supply (EIBS). DHb concentration was determined spectroscopically from five peri-ampullary locations.|Completion of study procedure (endoscopic ultrasound), approximately 30 minutes from procedure initiation|Among the 15 participants in the cancer group, 1 participant was excluded from the final analysis due to suboptimal measurements. Therefore 14 participants in the cancer group and 15 participants in the control group were included in the analysis population.|||alpha units||95% Confidence Interval|Mean
1429219|NCT01015807|Primary|Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups|Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section. The smaller the area of WHA, assessed in cm2, the better the outcome. Area sizes may range from 0 to any size.|48hrs after CS||||cm^2||Inter-Quartile Range|Mean
1429220|NCT01015781|Primary|Tinnitus Functional Index Change Score|"The Tinnitus Functional Index (TFI) is a tinnitus outcome measure that has been validated for “responsiveness” (Meikle et al., 2012). Prior to the TFI, no tinnitus questionnaire had been specifically designed and tested to maximize responsiveness to treatment-related change.~Completion of the 25-item TFI results in an index score that can range from 0 to 100, with higher scores reflecting greater problems associated with tinnitus. The following is a general guide to facilitate interpretation of TFI scores:~<25 = relatively mild tinnitus (little or no need for intervention)~25-50 = significant problems with tinnitus (possible need for intervention) •>50 = tinnitus severe enough to qualify for more aggressive intervention Data from the TFI development study (Meikle et al., 2012) suggest that a reduction in the TFI score of at least 13 points would indicate a clinical improvement that a patient would consider important or meaningful."|Baseline, 6 months (from Baseline)|"The analysis was intention to treat (ITT). Includes all subjects from whom both baseline and 6 month data were collected."|||units on a scale||Standard Deviation|Mean
1429221|NCT01015703|Primary|Safety Events|Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.|Duration of study||||percentage of patients|||Number
1429222|NCT01015677|Secondary|Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4|FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERα activity and a pharmacodynamic endpoint).|Baseline and Week 4|The Per-Protocol (PP) population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.|||mIU/mL||90% Confidence Interval|Least Squares Mean
1429223|NCT01015677|Secondary|Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4|Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.|||Percent change||95% Confidence Interval|Least Squares Mean
1429224|NCT01015677|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The APaT population is all participants who received at least one dose of study drug.|||Participants|||Number
1429225|NCT01015677|Primary|Number of Participants Who Experienced at Least One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 6 weeks|The All-Patients-as Treated (APaT) population is all participants who received at least one dose of study drug.|||Participants|||Number
1429226|NCT01015677|Primary|Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4|Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.|Baseline and Week 4|The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.|||Percent change||95% Confidence Interval|Least Squares Mean
1429227|NCT01015638|Secondary|Subject Assessment - Oiliness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate oiliness, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of oiliness are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
1429228|NCT01015638|Secondary|Subject Assessment - Blistering|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate blistering, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of blistering are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
1429229|NCT01015638|Secondary|Subject Assessment - Crusting|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate crusting, burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of crusting are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
1429230|NCT01015638|Secondary|Subject Assessment - Pain|"At each visit, panelists were supplied a self-assessment questionnaire, which included assessment of pain.~Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of pain are presented here."|2 Weeks||||units on a scale||Standard Deviation|Mean
1429231|NCT01015638|Secondary|Subject Assessment - Roughness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, roughness, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of roughness are presented here."|2 weeks||||units on a scale||Standard Deviation|Mean
1429232|NCT01015638|Secondary|Subject Assessment - Dryness|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of dryness are presented here."|2 weeks||||units on a scale||Standard Deviation|Mean
1429233|NCT01015638|Secondary|Subject Tolerability - Stinging|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, and dryness in this questionnaire. Each symptom will be rated with the following scale: 0 – None,1 – Slight,2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of stinging are presented here."|2 weeks||||units on a scale||Standard Deviation|Mean
1429234|NCT01015638|Secondary|Subject Tolerability - Burning|"At each visit, panelists were supplied a self-assessment questionnaire. Subjects were asked to evaluate burning, stinging, pain, and dryness in this questionnaire. Each symptom was rated with the following scale: 0 – None, 1 – Slight, 2 – Moderate, or 3 – Severe.~The subjects completed this questionnaire prior to their daily application. The subjects used the time period (last 24 hours), from their last study application to the time they are administered this questionnaire for rating each symptom. The results for assessment of burning are presented here."|2 weeks|ITT|||units on a scale||Standard Deviation|Mean
1429235|NCT01015638|Secondary|Changes in the Skin Surface Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|14 days|ITT|||microsiemens||Standard Deviation|Mean
1429236|NCT01015638|Primary|Skin Dryness|"Visual Dryness was evaluated using the following scale:~Grade 0 = None 2 = Slight flaking 4 = Moderate flaking/scaling 6 = Marked scaling / slight fissuring 8 Severe scaling, fissuring"|14 days|ITT|||units on a scale||Standard Deviation|Mean
1429237|NCT01015638|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale as grams per meters squared (m^2) per hour. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration."|14 days||||grams/m^2/hour||Standard Deviation|Mean
1429238|NCT01015638|Primary|Erythema (Redness)|"Compare tolerability of clindamycin and benzoyl peroxide (BPO) 5% and clindamycin phosphate and benzoyl peroxide 2.5% using visual assessments by an independent blinded grader.~Erythema (redness) was evaluated using the following scale:~Erythema Grade Description 0 = None 2 = Mild erythema 4 = Moderate confluent erythema 6 = Marked erythema with some edema 8 = Marked erythema, edema, possible erosion"|14 days|ITT|||units on a scale||Standard Deviation|Mean
1429239|NCT01015560|Primary|uNTX Response Rate at 43 Days|Urinary n-telopeptide (uNTX) response is defined as a 25% reduction from baseline levels. Patients with missing response data were included as non-responders.|43 days|Eligible and analyzable patients|||percentage of participants||95% Confidence Interval|Number
1429240|NCT01015534|Secondary|Number of Grade 3-4 Adverse Events (AE) That Are Definitely or Probably Related to Both Groups of Treatment.|"AE, evaluated and graded according to the NCI common terminology criteria (NCI-CTCAE) v3.0~Grade 3 Severe AE.~Grade 4 Life-threatening or disabling AE."|4 months|Participants were assessed with a Complete blood count at the end of the first and second weeks of treatment. A standard biochemical profile was performed at the end of the second week of treatment, at 2 weeks after completion and at 2 months thereafter. Participants also were evaluated clinically with the same periodicity .|||Events|||Number
1429241|NCT01015534|Secondary|Overall Survival|Overall survival:Time in months measured from treatment initiation until the date of death or the date of last follow-up.|1 year|Data on all enrolled participants were included in an intention-to-treat analysis.|||Months of Overall Survival||95% Confidence Interval|Median
1429242|NCT01015534|Secondary|Survival Free of Brain Metastases Progression (PFS of BM)|Progression free survival of brain metastases is the survival of participants without progressive brain metastases or without neurological symptoms. The progressive brain metastases (PBM) were evaluated with cranial MRI. The PBM were defined as an increase of at least 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new metastases.|at 90 days|Data on all enrolled participants were included in an intention-to-treat analysis.|||Percentage of Participants||95% Confidence Interval|Number
1429243|NCT01015534|Primary|Objective Response Rates. Assessed With Cranial MRI|"Objective Response (OR) encompassed the number of participants with Complete Response (CR) and the number of participants with Partial Response (PR). CR is the disappearance of all brain metastases, assessed between two or more cranial MRI. PR is at least a 30% decrease in the sum of the longest diameter of the brain metastases, taking as reference the baseline sum longest diameter, assessed between two or more cranial MRI.~Objective Response Rate (ORR) is the ratio between the number of participants with objective response and the total number of participants."|90 days|Data on all enrolled participants were included in an intention-to-treat analysis.|||Percentage of participants with OR||95% Confidence Interval|Number
1429244|NCT01015443|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occur between first dose of study drug administration and 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAE leading to death and permanent discontinuation of any trial treatment were presented.|From the first dose of study drug administration until 42 days after the last dose of study drug administration, assessed up to 5.6 years|Safety analysis set included all subjects who received at least one dose of trial treatment.|||Subjects|||Number
1429245|NCT01015443|Secondary|Time to Treatment Failure (TTF)|TTF was time from randomization to discontinuation of trial treatment for any reason as reported by the investigator. For subjects still receiving treatment at the time of analysis, the time between the date of randomization and the last date of treatment will be used as a censored observation in the analysis. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered treatment failure and the TTF was calculated from the date of randomization to the date of their first missed treatment.|From the date of randomization to the date of first missed treatment, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
1429246|NCT01015443|Secondary|Progression Free Survival (PFS)|Time from randomization to objective disease progression (PD) as determined by the investigator or death. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, and the PFS was calculated from the date of randomization to the date of their first missed treatment. PFS time for subjects without an event was censored as of the date of last performed imaging.|From the date of randomization to PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
1429495|NCT01014013|Secondary|Clinical Response Assessment Profile|The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Secondary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)|||Participants|||Number
1429247|NCT01015443|Secondary|Time to Progression (TTP)|Time from randomization to radiological confirmation of disease progression (PD) as determined by the investigator. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions from nadir, or the appearance of one or more new lesions as per RECIST version 1.0. For subjects without radiological confirmed PD who discontinued or died due to PD, the date of trial treatment discontinuation was used as event date. Subjects who missed 2 consecutive scheduled doses without evaluable assessment for the related visits and who were lost to follow-up thereafter were considered as having PD, TTP was calculated from the date of randomization to the date of their first missed treatment. Subjects without PD at time of analysis are censored at either date of last vaccination or death or discontinuation of treatment or lost to follow-up.|From the date of randomization to the date of radiological confirmation of PD, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
1429248|NCT01015443|Secondary|Time to Symptom Progression (TTSP)|TTSP was measured from randomization to symptomatic progression by lung cancer symptom scale (LCSS) used to measure symptom changes relevant to quality of life (QoL).It consisted of 9 items focused on cancer symptoms (loss of appetite, fatigue, cough, shortness of breath, blood in sputum, pain, symptoms of cancer, illness affecting normal activity, QoL).For each symptom score distance from left boundary to point where subject has marked line was measured in millimeters (mm).Total scale length was 100 mm. Symptomatic progression was defined as increase/worsening of average symptomatic burden index (ASBI) (mean of 6 major lung cancer specific symptom scores);Worsening defined as 10% increase of scale breadth from baseline. Score 0 indicate no/minimum symptoms;100 indicates maximum level of symptoms. Subjects without symptomatic progression/lost to follow-up at time of analysis: time from date of randomization to date of last LCSS assessment was calculated & used as censored observation.|From the date of randomization to the date of symptomatic progression, assessed up to 5.6 years|The mITT analysis set was based on the ITT analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
1429249|NCT01015443|Primary|Overall Survival (OS) Time|OS time was measured as the time (in months) between the date of randomization and the date of death. For subjects alive or lost to follow-up at time of analysis, the time between the date of randomization and the date on which the subject was last known alive was calculated and used as a censored observation in the analysis.|From the date of randomization until death, assessed up to 5.6 years|The modified intent-to-treat (mITT) analysis set was based on the intention-to-treat (ITT) analysis set (ITT analysis set included all the subjects randomized into the study), but included only subjects with concurrent primary chemo-radiotherapy and prospectively excluded the 5 subjects who were randomized prior to the clinical hold.|||Months||95% Confidence Interval|Median
1429250|NCT01015326|Primary|Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)|"Patients were asked How important is this symptoms or concern to your quality of life? They were given a series of items (listed in the table) and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. Experts were asked How important is this symptom or concern to patients' quality of life? They were given the same series of items and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to not at all important and 3 is equivalent to extremely important. For each item, a mean score was calculated using the values assigned to that item from all patients, and a second mean score was calculated using the values assigned to that item from all experts. An item's mean score may range from 0 to 3, where 0 is equivalent to not at all important to quality of life and where 3 is equivalent to extremely important to quality of life."|at time of questionnaire|Additional items that were variably collected and recorded have been omitted from the data set.|||units on a scale||Standard Deviation|Mean
1429251|NCT01015287|Other Pre-specified|Summary of All-Cause Death|All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.|Randomization through 30 days|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1429252|NCT01015287|Secondary|Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429253|NCT01015287|Secondary|Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)|Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.|Baseline, before PCI (not greater than 48 hours after randomization)|All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization).|||ratio of assayed troponin/ULN||Standard Error|Least Squares Mean
1429254|NCT01015287|Secondary|Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429412|NCT01014442|Primary|Free Fraction of Free MPA at Day 90|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
1429255|NCT01015287|Secondary|Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)|ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429256|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429257|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429258|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429259|NCT01015287|Secondary|Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)|The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First LD through 30 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429260|NCT01015287|Secondary|Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429261|NCT01015287|Primary|The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout|The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.|First loading dose (LD) through 7 days after first LD|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1429262|NCT01015170|Secondary|7-day Point Prevalence of Smoking Abstinence|"Number of participants who report Not Smoking (not even a puff) in past 7 days when asked 6 months after Zyban start date"|6 months after Zyban start date|Number of participants who completed 6 month post treatment survey|||Participants|||Count of Participants
1429263|NCT01015170|Secondary|Serious Quit Attempt (at Least 24 Hours of Abstinence)|Number of participants who report a serious quit attempt at End of treatment|End of Treatment (8 weeks after Zyban start date)|This secondary outcome was not collected at 8 week followup.||||||
1429264|NCT01015170|Primary|7-day Point Prevalence of Smoking Abstinence|"Number of participants who report Not Smoking (not even a puff) in past 7 days when asked at week 8"|End of Treatment (8 weeks after Zyban start date)|Participants who completed survey 8 weeks after Zyban start date|||participants|||Number
1429265|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmean measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
1429266|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their SUVmax measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
1429385|NCT01014728|Secondary|Surgeon’s Numeric Rating Scale (SNRS)|The surgeon’s numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.|||units on a scale||Full Range|Median
1429267|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmax determined at the end of Cycle 1 of chemotherapy.|||Correlation coefficient||90% Confidence Interval|Number
1429268|NCT01015131|Primary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 3 weeks|Participants who had both their changes from baseline in Ki-67 LI and SUVmean determined at the end of Cycle 1 of chemotherapy.|||Correlation coefficient||90% Confidence Interval|Number
1429269|NCT01015131|Primary|Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNB) are obtained after completing imaging studies at baseline and approximately 2 to 3 weeks later, after the first cycle of chemotherapy. These tissue samples are then used to measure expression of the cell proliferation marker Ki-67, by manually counting percentage positive immunostained cells, denoted the labeling index (LI).|Baseline and up to 3 weeks|Participants whose Ki-67 Labeling Index were measured at Baseline and after 1 cycle of chemotherapy|||Labeling Index||Standard Deviation|Mean
1429270|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of tissue radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmax measures the maximum radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy|||SUV||Standard Deviation|Mean
1429271|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their Ki-67 LI measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
1429272|NCT01015131|Secondary|Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used.|Baseline and up to 30 weeks|Participants who had their PSS measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy|||Correlation coefficient||90% Confidence Interval|Number
1429273|NCT01015131|Secondary|Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.|MRI of participants was used to measure tumor volumes at baseline and after completing chemotherapy, after approximately 11 to 30 weeks of treatment.|Baseline and up to 30 weeks|Participants who had tumors measured by MRI at Baseline and at the end of chemotherapy|||cm^3||Standard Deviation|Mean
1429274|NCT01015131|Secondary|Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy.|Core needle biopsies (CNBs) obtained at baseline and after approximately 2-3 weeks of treatment, at the end of the first cycle of chemotherapy, are used to measure cell proliferation by a Proliferation Signature Score (PSS). PSS is calculated from the messenger RNA (mRNA) expression of 47 genes that negatively correlate with time to recurrence, and involves taking their average normalized scores. For reference, a database of 16,000 tumors gave a minimum PSS of 1.51 and a maximum PSS of 2.89; where a higher PSS is associated with an increase in proliferation, higher tumor grade and worse outcomes.|Baseline and up to 3 weeks|Participants who had PSS determined at Baseline and after 1 cycle of chemotherapy|||Proliferation Score||Standard Deviation|Mean
1429275|NCT01015131|Primary|Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy.|Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest.|Baseline and up to 3 weeks|Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy|||SUV||Standard Deviation|Mean
1429276|NCT01015118|Secondary|Change in Global Health Status/ Quality of Life (QoL) Scale Over Time.|"Change in Global Health Status/ Quality of life (QoL) over time was calculated on Global Health Status/QoL scale (composite of items 29 and 30 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) as a general measure.~As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/healthy level of functioning).~Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with global health status/QoL|||units on a scale||Standard Error|Mean
1429386|NCT01014728|Secondary|Anesthesiologist Numeric Rating Scale (ANRS)|The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).|at the end of surgery (up to 6 hours)|There were three patients in the inhalation anesthesia group with missing values.|||units on a scale||Full Range|Median
1429277|NCT01015118|Secondary|Change in Abdominal/Gastro-intestinal Symptoms Over Time|"Change in abdominal/gastro-intestinal over time was calculated on symptoms (scale composite of items 31 to 37 of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Module for Ovarian Cancer 28 (EORTC QLQ OV-28).~As specified in the EORTC scoring manual, for each scale or item, a linear transformation was applied to standardize the raw score to a range from 0 to 100 (high scores represent a high/severe level of symptomatology).~Mean presented is Adjusted mean. Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), FIGO stage (IIB−III vs IV), and Carboplatin level (AUC5 vs. AUC6)."|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with abdominal/gastro-intestinal symptoms|||units on a scale||Standard Error|Mean
1429278|NCT01015118|Secondary|Objective Response Based on Investigator Assessment|Objective tumour response defined as either complete response [CR] or partial response [PR] in patients with at least 1 target lesion reported at baseline|First drug administration until final DBL 26September16, upto 62 months|Randomised Set (RS) for patients with at least 1 target lesion reported at baseline|||percentage of participants|||Number
1429279|NCT01015118|Secondary|Time to CA-125 Tumour Marker Progression|Time to tumour-marker progression was defined as the time from randomisation until the date when Carbohydrate (cancer) antigen (CA-125) values increased to higher than twice the nadir value. CA-125 >=2 x nadir in case nadir value > Upper limit of normal (ULN) or CA-125 >=2 x ULN in case nadir value <= ULN.|First drug administration until final DBL 26September16, upto 62 months|Randomised set (RS)|||Months||Inter-Quartile Range|Median
1429280|NCT01015118|Secondary|Overall Survival|"Overall survival is defined as time from randomization to date of death (irrespective of reason).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of death until final DBL 26September16, upto 62 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
1429281|NCT01015118|Secondary|PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint - Follow up Analysis).|Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm.|First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
1429282|NCT01015118|Secondary|PFS Based on Investigator Assessment According to mRECIST Version 1.1 (Key Secondary Endpoint).|"Progression free survival is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first based on the Investigator assessment according to Modified Response Evaluation Criteria (mRECIST), version 1.1.~The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first , upto 29 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
1429283|NCT01015118|Primary|PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria (Follow up Analysis).|"Follow-up analysis was conducted at the time of overall survival analysis. Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first until final Data Base Lock (DBL) 26September16, upto 62 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
1429284|NCT01015118|Primary|PFS Based on Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST), and Additional Clinical Criteria.|"Progression free survival (PFS) is calculated as the time from randomisation to the date of disease progression, or to the date of death, whichever occurs first according to the Investigator assessment.~The primary PFS analysis of this trial was performed when approximately 753 patients had experienced a PFS event~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve for each treatment arm."|First drug administration to date of disease progression or death whichever occurs first , upto 29 months|Randomised Set (RS)|||Months||Inter-Quartile Range|Median
1429285|NCT01014988|Secondary|Geometric Mean Volume of Distribution (Vd) of Zanamivir|"The Vd of zanamivir was evaluated. Volume of distribution is defined as the apparent volume in which zanamivir is distributed. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >= 80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
1429286|NCT01014988|Secondary|Geometric Mean Serum Clearance of Zanamivir|"The serum clearance of zanamivir was evaluated. Clearance is defined as the volume of zanamivir per unit time eliminated from serum. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||mL per minutes||Geometric Coefficient of Variation|Geometric Mean
1429287|NCT01014988|Secondary|Geometric Mean Terminal Half Life (t1/2) of Zanamivir|"The t1/2 of zanamivir was evaluated. Terminal half life is defined as the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Day 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr>=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
1429288|NCT01014988|Secondary|Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir|"The AUC(0-tau) during the repeat dose interval and AUC(0-inf) for the initial dose were evaluated. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population|||Micrograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1429289|NCT01014988|Secondary|Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion|"The Cmax of zanamivir was evaluated at the end of infusion. Serial blood samples for pharmacokinetic (PK) analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants who were neither on extracorporeal membrane oxygenation (ECMO) nor on continuous renal replacement therapy (CRRT), who were with CLcr >=80 mL/minutes (>=80mL/minute/1.73m^2 for cohorts 1-4) and who received an initial dose (ID) and a maintenance dose (MD) of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. NA indicates that data are not available/analysis was not performed."|Day 1 and Days 3, 4, or 5|PK Parameter Population: participants with one or more estimated zanamivir PK parameters|||Micrograms per mL||Geometric Coefficient of Variation|Geometric Mean
1429290|NCT01014988|Secondary|Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays|The duration of hospitalization (H) reflects the number of hospitalization days between the date of the first dose of investigational product and the date of discharge. ICU stay includes total duration in ICU and may include days in ICU before entry into the study. For participants with a missing discharge date who were not discharged at the end of the study, the date of discharge was imputed to the last follow-up visit (post-treatment +23 days). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to discharge from hospital|ITT-E Population|||Days||Full Range|Median
1429291|NCT01014988|Secondary|Number of Participants Who Used Any Concomitant Antibiotic Medications for Complications of Influenza|Concomitant medications (prescription and non-prescription) were permitted during the course of the study at the Investigator’s discretion (except for prohibited medications: during the treatment period with IV zanamivir, other influenza antiviral drugs were not permitted). The number of participants who were treated with antibiotics for influenza complications was summarized.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
1429292|NCT01014988|Secondary|Number of Participants With Any AE Categorized as an Influenza Complication|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
1429293|NCT01014988|Secondary|Median Time to Clinical Response (Sustained Resolution) of All Vital Signs (Composite)|Sustained resolution of the following vital signs (composite) was assessed: afebrile status, normal oxygen saturation, normal respiratory status, normal HR, and normal BP. Clinical response is defined as the resolution of at least four of five vital signs within the following resolution criteria, maintained for 24 hours or hospital discharge, whichever occurred first: Temperature in degrees Centigrade (<=36.6 axilla, <=37.2 oral, <=37.7 rectal, core or tympanic); oxygen saturation (>=95%, without supplemental oxygen); respiratory status (return to pre-morbid oxygen requirement, or no need for supplemental oxygen, or respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute without supplemental oxygen for Cohorts 1-6 respectively); HR (<=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively); SBP (>=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Days||Full Range|Median
1429294|NCT01014988|Secondary|Number of Participants With the Indicated Mortality Status at Day 14 and Day 28|The number of participants who died on or before Study Day 14 and Study Day 28 was summarized. Only those participants available at the specified time points were analyzed.|Day 14 and Day 28|ITT-E Population|||Participants|||Number
1429295|NCT01014988|Secondary|Median Time to Return to Pre-morbid Functional Status|Time to return to pre-morbid functional status was assessed on a 3-point scale (bed rest, limited ambulation, or unrestricted). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Days||Full Range|Median
1429296|NCT01014988|Secondary|Duration of Mechanical Ventilation and Supplemental Oxygen Use|Due to the conditional nature of data collection post treatment, the duration of mechanical ventilation and supplemental oxygen use were not determined.|Up to discharge from the hospital|ITT-E Population||||||
1429297|NCT01014988|Secondary|Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation|Ventilation status was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Ventilation status was assessed once daily during inpatient follow-up visits. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD) at “any time (AT) on study” and at Baseline (Day 1) are summarized.|Up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
1429298|NCT01014988|Secondary|Median Time to Resolution of Individual Vital Signs|Times to return to afebrile status (normal body temperature), normal respiratory status, normal heart rate, and normal systolic blood pressure were assessed. Afebrile status is defined as a temperature <=36.6 axilla, <=37.2 oral, or <=37.7 rectal, core or typanic, degrees Centigrade. A return to normal respiratory status is defined as either: (a) return to pre-morbid oxygen requirement; or (b) return to no need for supplemental oxygen; or (c) respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute (without supplemental oxygen) for Cohorts 1-6 respectively . A normal HR is defined as <=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively, and a normal SBP is defined as >=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).|Up to post-treatment (PT) + 23 days|ITT-E Population|||Days||Full Range|Median
1429299|NCT01014988|Secondary|Number of Participants With Treatment-emergent (TE) Mutations|Viral RNA isolated from participants at Baseline (Day 1) and post-Baseline visits were sequenced to determine the presence of TE neuraminidase (NA) and hemagglutinin (HA) mutations resulting from selective pressure. A mutation was considered to be TE if it was not present at Baseline and was present in the last post-Baseline sample analyzed.These mutations were classified as either known to confer zanamvir resistance or novel mutations with unknown clinical significance. Please note: pediatric data are pending and will be updated when available.|Baseline and up to post-treatment (PT) + 23 days|ITT-E Population|||Participants|||Number
1429300|NCT01014988|Secondary|Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively|"Viral susceptibility to zanamivir at Baseline and at all post-Baseline visits collectively was assessed by neuraminidase (NA) enzyme inhibition assay. The mean IC50 data are summarized by subtype (A/H1N1, A/H3N2, B) and by visit. IC50 is defined as the concentration of zanamvir required to inhibit NA activity by 50%. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data are not available/analysis was not performed. Please note: pediatric data are pending and will be updated when available."|Baseline and up to post-treatment (PT) + 23 days|ITT-E Population|||Nanomolar (nM)||Standard Deviation|Mean
1429301|NCT01014988|Secondary|Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points|"Change from Baseline in viral load was measured from nasopharyngeal swab samples, as determined by RT-PCR (PCR positive at Baseline). Nasopharyngeal swab samples were collected at Baseline (Day 1); Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10; and, only if the participants had continued symptoms and were hospitalized, post-treatment (PT) samples were collected at +2 days, +5 days, +9 days, +16 days, and +23 days. 'PT +23 days' also comprises viral load values at early study withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). NA indicates that data are not available/analysis was not performed."|Baseline (Day 1); Days 2, 3, 4, 5, 7, and 10; and post-treatment +2, +5, +9, +16, +23 days|ITT-E Population|||Log10 copies per milliliter||Full Range|Median
1429302|NCT01014988|Secondary|Median Time to Virologic Improvement|Time to virologic improvement is defined as a 2-log drop in viral load or undetectable viral ribonucleic acid (RNA) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples (PCR positive at Baseline). Only those participants available at the specified time points were analyzed.|Up to post-treatment (PT) + 23 days|ITT-E Population consisted of all participants who receiveed at least one dose of IV zanamivir.|||Days||Full Range|Median
1429303|NCT01014988|Primary|Median Corrected QT Interval (QTc) for Heart Rate by Fridericia’s Formula (QTcF) and Bazett’s Formula (QTcB) at Baseline (Day 1) and Day 5|"Twelve-lead ECGs were recorded for the parameters of QTcF and QTcB. The first set of pre-dose ECG values at Baseline (Day 1) and the pre-dose ECG values at Day 5 are presented. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles). NA indicates that data are not available/analysis was not performed. Cohort 1 QTcF and QTcB minimum values of 0.0 were data entry errors that could not be addressed after Data Base Freeze."|Baseline (Day 1) and Day 5|Safety Population|||Milliseconds||Full Range|Median
1429304|NCT01014988|Primary|Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)|The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).|Baseline (Day 1)|Safety Population|||Participants|||Number
1429305|NCT01014988|Primary|Median Body Temperature at Baseline (Day 1) and Day 5|Body temperature was recorded at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Body temperature was recorded once daily during inpatient or outpatient follow-up visits. Median body temperature at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Degrees centigrade||Full Range|Median
1429656|NCT01012323|Secondary|IgG Trough Level Concentration|Total IgG trough concentrations were measured in serum samples taken before each infusion.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||g/L||Standard Deviation|Mean
1429306|NCT01014988|Primary|Median Respiration Rate at Baseline (Day 1) and Day 5|Respiration rate was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Respiration rate was assessed once daily during inpatient or outpatient follow-up visits. The median respiration rate at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Breaths per minute||Full Range|Median
1429307|NCT01014988|Primary|Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5|TCPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin. Because oxygen is carried to tissues by blood flow in the arteries, TCPO2 is an indirect measure of blood flow. The percent (%) oxygen saturation was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Oxygen saturation was assessed once daily during inpatient follow-up visits. The median oxygen saturation values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Percentage of oxygen level in blood||Full Range|Median
1429308|NCT01014988|Primary|Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5|SBP and DBP were measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. SBP and DBP were assessed once daily during inpatient or outpatient follow-up visits. SBP and DBP values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Millimeters of mercury (mmHg)||Full Range|Median
1429309|NCT01014988|Primary|Median Heart Rate at Baseline (Day 1) and Day 5|Heart rate was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Heart rate was assessed once daily during inpatient or outpatient follow-up visits. Heart rate values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Beats per minute (bpm)||Full Range|Median
1429310|NCT01014988|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, TN, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to post-treatment (PT) + 23 days|Safety Population|||Participants|||Number
1429311|NCT01014988|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities|A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included ALT, TB, and creatinine. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to post-treatment (PT) + 23 days|Safety Population|||Participants|||Number
1429312|NCT01014988|Primary|Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5|Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Hematology parameters included hemoglobin, total neutrophils (TN), and white blood cell (WBC) count. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated hematology parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Participants|||Number
1429313|NCT01014988|Primary|Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5|Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Clinical chemistry parameters included alanine aminotransferase (ALT), direct bilirubin (DB), total bilirubin (TB), and creatinine. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated clinical chemistry parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1) and Day 5|Safety Population|||Participants|||Number
1429314|NCT01014988|Primary|Number of Participants Who Were Permanently Discontinued From the Study Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to post-treatment (PT) + 23 days|Safety Population.|||Participants|||Number
1429387|NCT01014728|Primary|Estimated Blood Loss|Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.|from the start of surgery to the end of surgery, up to 6 hours||||mL/h||Standard Deviation|Mean
1429315|NCT01014988|Primary|Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|Up to 10 days|Safety Population.|||Participants|||Number
1429316|NCT01014988|Primary|Number of Participants With Any Severe or Grade 3/4 Treatment-related AE|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assesed by the Investigateor as related or not related to the study treatment.|Up to post-treatment (PT) + 23 days|Safety Population.|||Participants|||Number
1429317|NCT01014988|Primary|Number of Participants With Any Severe or Grade 3/4 AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening.|Up to post-treatment (PT) + 23 days|Safety Population.|||Participants|||Number
1429318|NCT01014988|Primary|Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. All AEs were assesed by the Investigateor as related or not related to the study treatment.|Up to post-treatment (PT) + 23 days|Safety Population: participants who received >=1 dose of study medication.|||Participants|||Number
1429319|NCT01014975|Primary|Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort||90 days|Safety Population|||participants|||Number
1429320|NCT01014936|Secondary|Progression-free Survival (PFS)|PFS was defined as the time (in months) between the first dosing day and radiographic PD or clinical PD (as recorded on the study termination form) or death, if death occurred within 12 weeks (84 days) after the last tumor assessment without documented progressive disease, whichever occurred first. Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment.|Baseline up to 153.3 weeks|"Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||months||90% Confidence Interval|Median
1429321|NCT01014936|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Baseline up to 153.3 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
1429322|NCT01014936|Secondary|Relative Percentage Change In Sum of Longest Diameter (SOLD) of Target Lesions to Post-Baseline Nadir|The post-baseline nadir was defined as the the smallest SOLD recorded after baseline. The relative change (%) was derived based on the SOLD of target lesions as follows: 100* (SOLD at post-baseline nadir - baseline SOLD) / baseline SOLD.|Baseline, On Treatment (up to 153.3 weeks)|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here “Number of Participants Analyzed” signifies those subjects who presented a measurable tumor at baseline and at least one post-baseline tumor assessment.|||percent change||Standard Deviation|Mean
1429323|NCT01014936|Secondary|Number of Subjects With Monovalent Antagonist Antibody to Receptor MET (MetMAb) Score (MMS)|MetMAb score was used to assess the tumor c-Met expression and ranged from 0 to 3, where a score of 0 corresponds to the lowest c-Met expression and a score of 3 corresponds to the highest c-Met expression in tumor tissue by immunohistochemistry.|Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
1429324|NCT01014936|Secondary|Fold Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2|Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein. Fold change = on-treatment value/ baseline value|Baseline, Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome and “n” signifies those subjects who were evaluable in the specified category for each arm, respectively.|||fold change||Standard Deviation|Mean
1429325|NCT01014936|Secondary|Absolute Change From Baseline in Cytoplasm and Membrane H-Score at Day 1 Cycle 2|Histo score (H-score) is a composite score that comprises of intensity and percentage of staining and is used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Baseline, Day 1 Cycle 2|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429326|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 3|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
1429327|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 2|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
1429328|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Multiple Dose of MSC2156119J: Regimen 1|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
1429329|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 3|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
1429330|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 2|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
1429331|NCT01014936|Secondary|Apparent Terminal Rate Constant (λz) After Single Dose of MSC2156119J: Regimen 1|Apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant.||||||
1429332|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 3|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
1429333|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
1429334|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After Multiple Dose of MSC2156119J: Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
1429335|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 3|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
1429388|NCT01014689|Secondary|Success Rate on the Investigator’s Global Assessment (IGA) at Week 12|Percentage of Subjects “Clear” or “Almost Clear” on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12.|Baseline and Week 12|Intention To treat - Last Observation Carried Forward|||percent of subjects|||Number
1429336|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 2|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
1429337|NCT01014936|Secondary|Apparent Volume of Distribution (Vz/f) After First Dose of MSC2156119J: Regimen 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of Vz/f.||||||
1429338|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 3|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
1429339|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 2|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
1429340|NCT01014936|Secondary|Apparent Body Clearance (CL/f) After First Dose of MSC2156119J: Regimen 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from plasma, CL= Dose/AUC0−inf.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
1429341|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429342|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429343|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Multiple Dose of MSC2156119: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429344|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429345|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429346|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve Within One Dosing Interval (AUCtau) After Single Dose of MSC2156119: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429389|NCT01014689|Primary|Percent Change From Baseline in Total Lesion Count|Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12.|Baseline and Week 12|Intention to treat - Last observation carried forward|||percent of change||Full Range|Median
1429347|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 3|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.||||||
1429348|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 2|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.||||||
1429349|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) After Single Dose Of MSC2156119J: Regimen 1|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUC0-inf.||||||
1429350|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 3|"Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule. Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429351|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 2|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429352|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After Multiple Dose of MSC2156119J : Regimen 1|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429353|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 3|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429354|NCT01014936|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 2|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the LLQ. AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429355|NCT01014936|Secondary|Area Under Plasma Concentration Versus Time Curve From Time Zero to Last Sampling Time (AUC0-t) After First Dose of MSC2156119J: Regimen 1|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429356|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 3|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
1429357|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 2|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
1429358|NCT01014936|Secondary|Apparent Terminal Half-life (t1/2) After Multiple Dose Of MSC2156119J: Regimen 1|Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
1429359|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 3|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
1429360|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 2|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
1429361|NCT01014936|Secondary|Apparent Terminal Half-life ( t1/2) After Single Dose Of MSC2156119J: Regimen 1|Apparent Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
1429362|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||hours||Full Range|Median
1429363|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure|||hours||Full Range|Median
1429364|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||hours||Full Range|Median
1429365|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||hours||Full Range|Median
1429366|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24, 48, 49.32 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||hours||Full Range|Median
1429367|NCT01014936|Secondary|Time To Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||hours||Full Range|Median
1429368|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 3|"Reporting group MSC2156119J 1200 mg: Fasted is not applicable for Multiple Dosing because only one subject was erroneously dosed with 1200 mg in fasted state as a single dose in Regimen 3. For multiple dose PK profile (Study Day 14), this subject was included in reporting group MSC2156119J 1400 mg: Fed."|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429369|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 19 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429370|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose. Here, “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429371|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 3||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429372|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 2||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1429373|NCT01014936|Secondary|Observed Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J: Regimen 1||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|Pharmacokinetic (PK) analysis set included all subjects who had received at least 1 dose of MSC2156119J and who had provided at least 1 concentration of MSC2156119J measurement after the first dose.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1429374|NCT01014936|Secondary|Number of Subjects With Treatment-Emergent AEs (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 158.01 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
1429375|NCT01014936|Primary|Number of Subjects With Treatment-Related Adverse Events|Related AE was defined as any untoward medical occurrence which was considered to have a relationship with the study drug (suspected to be reasonably related to the study drug or AE was medically (pharmacologically/clinically) attributed to the study drug as per Investigator’s assessment.|Baseline up to 158.01 weeks|Safety set included all subjects who had received at least 1 dose of MSC2156119J treatment.|||subjects|||Number
1429376|NCT01014936|Primary|Recommended Phase 2 Dose (RP2D)|MTD was defined as the dose level at which 2 out of 3 subjects or 2 out of 6 subjects experienced a DLT. The primary endpoint was to determine MTD of MSC2156119J for each of the 3 treatment regimens in subjects with advanced solid tumors. However, during the course of the trial it was established that the MTD could not be determined and instead, RP2D was to be determined.|Cycle 1 (Day 1 to Day 21)|DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1.|||milligram|||Number
1429377|NCT01014936|Primary|Number of Subjects With Any Dose Limiting Toxicity (DLT)|DLT was defined as one of the following adverse events (AEs) observed during Cycle1, regardless of MSC2156119J relationship, excluding AEs assessed by investigator exclusively related to subject’s underlying disease or medical condition: Grade 4 neutropenia for >7 days; Grade >=3 febrile neutropenia for >1 day; Grade 4 thrombocytopenia/Grade 3 with bleeding; Grade >=3 nausea and emesis, despite optimal treatment; Grade >=3 non-hematological AE, except emesis and nausea with no adequate therapy and alopecia, Grade >= 3 liver AE with a recovery period of >7 days or to Grade <=1 for subjects without liver metastases or to <=2 for subjects with liver metastases; Grade >=3 lipase and/or amylase rise with pancreatitis confirmation, either based on clinical or radiological signs. Any AE not otherwise defined as a DLT that, due to prolonged recovery to Grade <=1 or baseline status, leads to delay of above 21 days in planned administration of study drug.|Day 1, 3, 8, 14, 17 of Cycle 1 (for Regimen 1 and 3); Day 1, 3, 8, 15, 19 of Cycle 1 (for Regimen 2)|DLT analysis set comprised of subjects who had either completed Cycle 1 or had stopped treatment because of a DLT during Cycle 1.|||subjects|||Number
1429378|NCT01014910|Secondary|Clinical Deterioration Necessitating Transfer to Higher Level of Care||Summarized from admission to hospital discharge||||participants|||Number
1429379|NCT01014910|Primary|Length of Stay in the Hospital||Summarized from admission to hospital discharge||||hours||Inter-Quartile Range|Median
1429380|NCT01014871|Primary|Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead|Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.|5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5|Intention To Treat|||Scores on a scale||Standard Deviation|Mean
1429381|NCT01014741|Secondary|Radiofrequency Ablation Time||at time of the procedure||||minutes||Standard Deviation|Mean
1429382|NCT01014741|Secondary|AF Termination|AF termination with complex fractionated atrial electrograms (CFAE) ablation|at time of the procedure||||participants|||Number
1429383|NCT01014741|Secondary|Procedure Time|Overall procedure duration|at time of the procedure||||minutes||Standard Deviation|Mean
1429390|NCT01014624|Secondary|Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose.|Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to R-to-B PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to R-to-B PRU derived from: Number days to R-to-B PRU=-3.350+0.079*PI(1)+0.014*baseline PRU.|up to 12 days after the last dose|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). The primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units.|||days to return to baseline PRU|||Number
1429391|NCT01014624|Secondary|Percentage of Platelet Inhibition on Washout Day 1|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|Washout Day 1|Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3).|||Percentage||Standard Deviation|Mean
1429392|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%|up to 12 days after the last dose|Subjects in Responder Pop. using secondary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Responder Pop. was primary pop. excluding poor pharmacodynamic responders. Secondary definition of R-to-B was (Baseline PRU-PRU)/ (Baseline PRU) <= 20%|||day50%, 75%, 90% returned to baseline|||Number
1429393|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Responder Pop. using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at baseline and Washout Day 1. Responder Pop. was Primary Pop. excluding poor pharmacodynamic responders. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units|||day 50%, 75%, 90% returned to baseline|||Number
1429394|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using secondary definition of return to baseline. Primary Population included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%|||day 50%, 75%, 90% returned to baseline|||Number
1429395|NCT01014624|Secondary|Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population.|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.|up to 12 days after last dose|Subjects in Primary Population using primary definition of return to baseline. Primary population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units|||day 50%, 75%, 90% returned to baseline|||Number
1429396|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline.|On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%|up to 12 days after last dose|Subjects in Primary Pop. using secondary definition of return to baseline. Primary Population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%|||cumulative percent returned to baseline|||Number
1429410|NCT01014442|Secondary|Percent of Predicted FEV1 at Day 90 Post-Transplantation|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100%|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for this outcome measure.|||percentage of predicted FEV1||Standard Deviation|Mean
1446645|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])||Baseline up to Month 7||||percentage of participants|||Number
1429397|NCT01014624|Primary|The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline|On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of subjects.|up to 12 days after last dose|Subjects in Primary Population (Pop.) using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units.|||cumulative percentage of subjects|||Number
1429398|NCT01014585|Secondary|Time to Worsening in Multidimensional Assessment of Fatigue (MAF)|Time to worsening in MAF is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a 10-point increase from baseline in the global index of fatigue in MAF. Scores range from 1 (no fatigue) to 50 (severe fatigue). The MAF contains 16 items measuring 4 dimensions of fatigue: severity, distress, degree of interference in activities of daily living, and timing. Fourteen of the items contain numerical rating scales (increasing in severity); the remaining 2 items have multiple-choice responses (decreasing in severity).|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.|||Days||95% Confidence Interval|Median
1429399|NCT01014585|Secondary|Time to Worsening in Patient Global Impression of Change (PGIC)|"Time to worsening in Patient Global Impression of Change is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a PGIC score of 6 or 7. The PGIC is an efficacy assessment on a scale of 1-7 taken at visits 4, 5, 6 and 7. The wording of the assessment is as follows: Since the start of the study, overall my fibromyalgia is: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse."|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.|||Days||95% Confidence Interval|Median
1429400|NCT01014585|Primary|Time to Loss of Therapeutic Response (LTR)|Time to loss of therapeutic response is defined as the time from the first dose of double-blind investigational product to the first visit when a patient has a < 30% reduction in Visual Analog Scale (VAS) pain score from pre-milnacipran exposure OR a worsening of fibromyalgia requiring, in the judgment of the investigator, an alternative treatment|From baseline Visit 3 (week 5) to Visit 7 (week 17)|The Intent to Treat (ITT) Population for Responders is defined as all patients in the Safety Population for Responders with at least 1 post-baseline assessment of primary efficacy parameter. All patients in the Safety Population were included in the ITT population. No efficacy statistical analyses were performed for the Non-Responder population.|||Days||95% Confidence Interval|Median
1429401|NCT01014533|Secondary|Relapse to Any Drinking|Relapse to any drinking is counted as participants who drank any beverage alcohol from end of sleep laboratory study (night 10) to twelve weeks later|12 weeks||||Participants|||Count of Participants
1429402|NCT01014533|Primary|Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication|Wake time after sleep onset (WASO) (number of minutes awake throughout the night after initial sleep onset)|1 week||||minutes||Standard Deviation|Mean
1429403|NCT01014533|Primary|Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)|Electrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep|1 week||||percentage of total sleep time||Standard Deviation|Mean
1429404|NCT01014455|Primary|Exhaled CO Level Measured Immediately Prior to Surgery|On the morning of surgery, as matter of clinical routine all patients receiving surgery requiring anesthesia services at one of the two main surgical facilities at Mayo Clinic Rochester and who self-report as a current smoker are asked about their typical cigarette consumption (cigarettes per day), if they have smoked cigarettes today, and have their exhaled CO levels measured (Micro Smokerlyzer; Bedfont, United Kingdom). This information is entered into the clinical record. The CO monitors are maintained by the Division of Respiratory Therapy, including regular calibration.|The median time from study assessment at POE to surgery was 1 day with an interquartile range of 1 to 3 days.|5 participants did not complete CO measures and were excluded from the analysis of primary outcome|||ppm||Standard Deviation|Mean
1429405|NCT01014455|Primary|Preoperative Carbon Monoxide Levels||the morning of surgery|||||||
1429406|NCT01014442|Secondary|Percentage of Participants With Opportunistic Infections|Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens.|Up to Day 90|Safety Population|||percentage of participants|||Number
1429407|NCT01014442|Secondary|Change From Baseline in T-Cell Phenotype|Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152.|Baseline, Days 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||percentage of lymphocytes||Standard Deviation|Mean
1429408|NCT01014442|Secondary|Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels|iATP was expressed in ng/mL.|Baseline, Days 4, 8, 20 and 90 post-transplantation|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category, for respective arm groups.|||ng/mL||Standard Deviation|Mean
1429409|NCT01014442|Secondary|Forced Vital Capacity (FVC) at Day 90 Post-Transplantation|FVC at Day 90 post-transplantation is reported.|Day 90 post-transplantation|ITT Population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||L||Standard Deviation|Mean
1429413|NCT01014442|Primary|Free Fraction of Free MPA at Day 20|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
1429414|NCT01014442|Primary|Free Fraction of Free MPA at Day 8|MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
1429415|NCT01014442|Primary|Free Fraction of Free MPA at Day 4|MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||percentage of free fraction||Standard Deviation|Mean
1429416|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
1429417|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
1429418|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
1429419|NCT01014442|Primary|Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours/L||Standard Deviation|Mean
1429420|NCT01014442|Primary|AUC0-12 of Free MPA at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
1429421|NCT01014442|Primary|AUC0-12 of Free MPA at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
1429422|NCT01014442|Primary|AUC0-12 of Free MPA at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
1429423|NCT01014442|Primary|AUC0-12 of Free MPA at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*mcg/L||Standard Deviation|Mean
1429424|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 90|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hours*(mg/L)||Standard Deviation|Mean
1429425|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 20|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*(mg/L)||Standard Deviation|Mean
1429426|NCT01014442|Primary|AUC0-12 of MPA, MPAG and AcMPAG at Day 8|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*(mg/L)||Standard Deviation|Mean
1429427|NCT01014442|Primary|Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4|AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||hours*(mg/L)||Standard Deviation|Mean
1429428|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 90|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||L/hour||Standard Deviation|Mean
1429429|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 20|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||L/hour||Standard Deviation|Mean
1429430|NCT01014442|Primary|CL of MPA, MPAG and AcMPAG at Day 8|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||L/hour||Standard Deviation|Mean
1429431|NCT01014442|Primary|Clearance (CL) of MPA, MPAG and AcMPAG at Day 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||L/hours||Standard Deviation|Mean
1429432|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 90|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
1429433|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 20|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
1429434|NCT01014442|Primary|Vz of MPA, MPAG and AcMPAG at Day 8|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
1429435|NCT01014442|Primary|Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4|Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||Liter||Standard Deviation|Mean
1429436|NCT01014442|Primary|Cmin of Free MPA at Day 90|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429437|NCT01014442|Primary|Cmin of Free MPA at Day 20|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429438|NCT01014442|Primary|Cmin of Free MPA at Day 8|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429439|NCT01014442|Primary|Cmin of Free MPA at Day 4|Cmin was expressed in mcg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429440|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 90|Cmin was expressed in mg/L.|Predose (0 hour) on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
1429441|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 20|Cmin was expressed in mg/L.|Predose (0 hour) on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
1429442|NCT01014442|Primary|Cmin of MPA, MPAG and AcMPAG at Day 8|Cmin was expressed in mg/L.|Predose (0 hour) on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
1429443|NCT01014442|Primary|Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4|Cmin was expressed in mg/L.|Predose (0 hour) on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||mg/L||Standard Deviation|Mean
1429444|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
1429445|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
1429446|NCT01014442|Primary|Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
1429447|NCT01014442|Primary|Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4||Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||hour||Standard Deviation|Mean
1429448|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
1429449|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
1429450|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8|Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
1429451|NCT01014442|Primary|Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4|Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure. Number of participants with available data for specified category are provided against individual category.|||1/L||Standard Deviation|Mean
1429452|NCT01014442|Primary|Cmax of Free MPA at Day 90|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429453|NCT01014442|Primary|Cmax of Free MPA at Day 20|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429454|NCT01014442|Primary|Cmax of Free MPA at Day 8|Cmax was expressed in mcg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429455|NCT01014442|Primary|Cmax of Free MPA at Day 4|Cmax was expressed in micrograms per liter (mcg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mcg/L||Standard Deviation|Mean
1429456|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 90|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
1429457|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 20|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
1429458|NCT01014442|Primary|Cmax of MPA, MPAG and AcMPAG at Day 8|Cmax was expressed in mg/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation|PP Population. Here, number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
1429459|NCT01014442|Primary|Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4|Cmax was expressed in milligrams per liter (mg/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation|Per Protocol (PP) Population: Intent-to treat (ITT) population (received at least one dose of study drug and where the primary variable was measured at least once under study drug) excluding participants with major protocol violations (total 46 participants). Number of participants analyzed=participants who were evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
1429460|NCT01014351|Secondary|Objective Response Rate (ORR)|Objective Response Rate (ORR) is defined as the Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||percentage of patients|||Number
1429461|NCT01014351|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from randomization until death from any cause.|18 months||||Months||95% Confidence Interval|Median
1441649|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
1429462|NCT01014351|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months||||Months||95% Confidence Interval|Median
1429463|NCT01014208|Secondary|Time to Engraftment After High-dose Therapy (HDT)/ASCT|Engraftment is defined as 1) three consecutive days when the ANC is ≥0.5x109/L and 2) an unsupported platelet count of ≥20x109/L, and the engraftment date is the date that this occurs. If engraftment was not achieved by Day 42 or the last observation, engraftment was deemed to be a failure, and censoring took place at Day 42 or at the last observation.|From ASCT up to 42 days post-ASCT (Baseline up to approximately 4.5 months)|Safety population. Only participants completing HDT/ASCT are included.|||Days||95% Confidence Interval|Median
1429464|NCT01014208|Secondary|Time to Neutrophil and Platelet Recovery After Each Cycle of Salvage Chemotherapy|Neutrophil (absolute neutrophil count [ANC]) recovery is defined as ANC >=0.5*10^9/Liter and increasing, and platelet (PLT) recovery is defined as PLT >=10*10^9/Liter and increasing. For each cycle, time to ANC recovery is defined as the time from the first dose to the first ANC >=0.5*10^9/Liter and increasing after the nadir in the cycle. For each cycle, time to PLT recovery is defined as the time from the first dose to the first PLT >=10*10^9/L and increasing after the nadir in the cycle.|From the start of each cycle for a maximum of 5 weeks per cycle (assessed during treatment period of Baseline up to approximately 3 months)|Safety Population. Only those participants available for analysis in the given cycle were assessed.|||days||95% Confidence Interval|Median
1429465|NCT01014208|Secondary|Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma Trial Outcome Index (FACT-Lym TOI) Total Score During Treatment|"The FACT-Lym TOI is a measure that combines the FACT-Lym subscale (15 items; responses to each item range from 0, Not at all to 4, Very much) with two domains taken from the FACT-G (responses to each item range from Not at all  to Very much): Physical Well-being (7 items: lack of energy, nausea, meeting family needs, pain, side effects, feels ill, spends time in bed) and Functional Well-being (7 items: ability to work, work fulfilment, ability to enjoy life, illness acceptance, ability to sleep well, enjoying things done for fun, satisfaction with quality of life). This index is designed to be sensitive to changes in treatment regimens. The total FACT-Lym TOI score ranges from 0 to 116; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.|||scores on a scale||Standard Error|Mean
1429466|NCT01014208|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) During Treatment|"The FACT-G was developed by the Functional Assessment of Chronic Illness Therapy (FACIT) group for use in adults in a wide range of oncology clinical trial populations. The 27 items of the FACT-G are scored in the following domains: Physical Well-being (7 items), Social/Family Wellbeing (7 items), Emotional Well-being (6 items), and Functional Well-being (7 items). Participants responded to the items on a five-point Likert scale ranging from 0, Not at all to 4, Very much. The total score ranges from 0 to 108; higher scores indicate a better patient-reported outcome/quality of life. Participants were asked to think back over the past week when responding to the items."|Baseline and the end of the treatment period (until approximately 4 to 6 weeks following Cycle 3 [assessed up to 3 months])|ITT Population. Only those participants who provided data were assessed.|||scores on a scale||Standard Error|Mean
1429467|NCT01014208|Secondary|Number of Participants Completing Autologous Stem Cell Transplant (ASCT)|The number of participants who completed ASCT is reported.|Approximately 4 to 6 weeks following Cycle 3 (assessed up to 3 months)|ITT Population|||Participants|||Number
1429468|NCT01014208|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram From Peripheral Blood|Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization is defined as the collection of >2*10^6 CD34+ cells/kg. Only those participants, who commenced harvest, following the administration of rituximab or ofatumumab in combination with DHAP combination chemotherapy, were assessed. The number of participants with adequate harvest of CD34+ stem cells (at least 2*10^6 CD34+ cells/kg) after dosing of salvage therapy in Cycle 2 and Cycle 3 was analyzed.|During Cycles 2 and/or 3 (Weeks 4-9)|ITT Population. Only participants commencing leukapheresis are included.|||Participants|||Number
1429469|NCT01014208|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death due to any cause. Participants who were still alive by the end of the study were censored.|From randomization to death due to any cause (assessed for up to 5 years)|ITT Population|||Months||95% Confidence Interval|Median
1429470|NCT01014208|Secondary|Event-free Survival|Event-free survival is defined as the time from randomization to progressive disease (PD; disease whose course is growth, or spread of the disease), stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for PD) after completion of 2 cycles of therapy, commencement of a new treatment for diffuse large B cell lymphoma (DLBCL) (e.g., radiotherapy), or death from any cause, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization to progressive disease, stable disease after completion of 2 cycles of therapy, commencement of a new treatment for DLBCL, or death due to any cause (assessed for up to 5 years)|ITT Population|||Months||95% Confidence Interval|Median
1429471|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) Three Months After Autologous Stem Cell Transplant|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At 3 months after completion of autologous stem cell transplantation (ASCT) (assessed up to 6 months)|ITT Population. Only participants completing HDT/ASCT are included.|||Participants|||Number
1429472|NCT01014208|Secondary|Number of Participants With Overall Response (OR) and Complete Response (CR) After Salvage Chemoimmunotherapy|OR is defined as the number of participants achieving either a complete response (CR) or a partial response (PR). CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR is defined as at least a 50% decrease from Baseline in the sum of the product of the diameters of target lesions. RRCML was used to assess CR and PR.|At completion of up to 3 cycles of salvage chemoimmunotherapy (assessed up to 9 weeks)|ITT Population|||Participants|||Number
1429473|NCT01014208|Primary|Progression-free Survival as Assessed by Independent Reviewers|Progression-free survival is defined as the interval of time from the randomization date until the date of stable disease (SD; failure to attain the criteria needed for a CR or PR and no fulfillment of the criteria for progressive disease [PD]) after two cycles of salvage chemotherapy, progression, or death, whichever occurs first. Disease progression was based on the assessments of independent reviewers for the disease under study. Disease progression was based on imaging data via the Revised Response Criteria for Malignant Lymphoma (RRCML).|From randomization until the date of stable disease after two cycles of salvage chemotherapy, progression, or death (assessed for up to 5 years)|Intent-to-Treat (ITT) Population: all participants who were randomized and commenced study therapy (at least one dose of a study drug)|||Months||95% Confidence Interval|Median
1429474|NCT01014169|Secondary|Maternal Practice Related to Correct Car Seat Use|Correct car seat use by all subjects who use cars was defined as placing the car seat in the back seat facing backwards and using the car seat every time the infant travels by car. The number reported is the number who report using the car seat correctly.|two days after discharge||||participants with correct car seat use|||Number
1429475|NCT01014169|Secondary|Maternal Practice Related to Breastfeeding Initiation|This measure assesses maternal report of breastfeeding. The number analyzed is the number who reported any breastfeeding.|two days after discharge||||participants who report breastfeeding|||Number
1429476|NCT01014169|Primary|The Primary Outcome of Interest is Maternal Practice Related to Supine Infant Sleep Position.|This measure assesses maternal report of placing the infant on the back to sleep (supine sleep position) as opposed to putting the infant on its side or stomach.|two days after discharge||||participants who report supine position|||Number
1429477|NCT01014143|Primary|Plaque Index|Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Four days|per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.|||Units on a scale||Standard Deviation|Mean
1429478|NCT01014091|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1429479|NCT01014091|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1429480|NCT01014091|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)|Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1429481|NCT01014091|Secondary|Number of Subjects With Any Medically-attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the entire study period (from Month 0 up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1429482|NCT01014091|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever > 39.0 °C.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1429494|NCT01014091|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen|Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1429483|NCT01014091|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1429484|NCT01014091|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
1429485|NCT01014091|Secondary|Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1429486|NCT01014091|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Subjects|||Number
1429487|NCT01014091|Secondary|Number of Seroconverted Subjects in Terms of HI Antibodies|Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below < 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Subjects|||Number
1429488|NCT01014091|Secondary|HI Antibody Titers Against Vaccine H1N1 Antigen|Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1429489|NCT01014091|Secondary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 0, Day 21 and Month 7|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Subjects|||Number
1429490|NCT01014091|Primary|Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer|GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1429491|NCT01014091|Primary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Subjects|||Number
1429492|NCT01014091|Primary|Number of Seroconverted Subjects in Terms of HI Antibodies|Seroconversion (SCR) was defined as: For initially seronegative subjects [pre-vaccination titer below (<) 1:10], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Subjects|||Number
1429493|NCT01014091|Primary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.|||Subjects|||Number
1429496|NCT01014013|Primary|The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment|Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.|Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days|Safety Analysis has been done 267 patients who received at least 1 dose of parenteral therapy (132 patients from MK0826 and 135 patients from Ceftriaxone)|||Participants|||Number
1429497|NCT01014013|Primary|Microbiological Response Assessment Profile|The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed|5 to 9 days post-therapy|Primary efficacy analysis was done for 137 evaluable patients (66 patients from MK0826 and 71 patients from Ceftriaxone)|||Participants|||Number
1429498|NCT01013961|Secondary|Duration of Response|Duration of response is defined to be time from first confirmed CR, PR or clinical CR to progression or to death without documentation of progression. Patients without confirmed CR, PR or clinical CR are censored at time 0. Those without documentation of progression are censored at the date of last disease assessment without progression, unless death occurs within three months following the date last known progression free.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
1429499|NCT01013961|Secondary|Time to Response|Time to response is defined to be time from randomization to first confirmed CR, PR or clinical CR. Those without confirmed CR, PR or clinical CR are censored at the date of last disease assessment.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
1429500|NCT01013961|Secondary|Progression-free Survival (PFS)|"PFS is defined to be time from randomization to progression (PD) or to death without documentation of progression. For patients without PD, follow-up is censored at the date of last disease assessment without PD, unless death occurs within three months following the date last known progression free.~PD is characterized by at least one of the following:~≥50% increase in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart (at least 1 node must be >2 cm). Appearance of new palpable lymph nodes (>1 cm in diameter).~≥50% increase in the size of liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly which was not previously present.~Absolute number of circulating lymphocytes with a count of >5x10^9/L~Transformation to a more aggressive histology"|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
1429501|NCT01013961|Secondary|Overall Survival (OS)|OS is defined to be time from randomization to death from any cause. Those still alive are censored at the date of last contact.|Assessed after 2 cycles of treatment, 2 months after completion of therapy and then yearly up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
1429502|NCT01013961|Primary|Proportion of Patients With Overall Response (OR)|"OR is defined as either CR, clinical CR, or partial response (PR) evaluated by NCI-WG96 criteria. CR has been defined in the other primary endpoint.~A clinical CR requires all of the following:~Absence of lymphadenopathy by physical examination~No hepatomegaly or splenomegaly. Spleen and/or liver, if considered enlarged at baseline, should not be palpable, due to disease, on physical exam~Absence of constitutional symptoms~Normal CBC as exhibited by:~A PR requires all the following for ≥2 months:~≥50% decrease in peripheral blood lymphocyte count from baseline~≥50% reduction in lymphadenopathy~≥50% reduction in size of liver and/or spleen~Polymorphonuclear leukocytes ≥1.5x10^9/L or 50% improvement over baseline~Platelets >100x10^9/L or 50% improvement over baseline~Hemoglobin >11.0 gm/dl or 50% improvement over baseline without transfusions~Any constitutional symptoms"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1429503|NCT01013961|Primary|Proportion of Patients With Complete Response (CR)|"Response was evaluated using NCI-WG96 criteria.~A CR requires all of the following for >= 2 months:~Absence of lymphadenopathy > 1 cm in diameter by physical examination~No hepatomegaly or splenomegaly on physical exam~No constitutional symptoms~Normal complete blood count (CBC)~Patients achieving a clinical CR with negative CT scan after 2 cycles of therapy are re-evaluated using immunohistochemical examination of bone marrow biopsy for residual CLL cells. Patients with no evidence of residual disease and no radiological evidence of residual CLL on CT scan of chest-abdomen-pelvis and no clinical evidence of CLL on clinical evaluation after completion of 2 cycles of therapy will be considered to have a CR with no evidence of residual disease"|Assessed after 2 cycles of treatment and 2 months after completion of therapy|All randomized patients|||proportion of participants||95% Confidence Interval|Number
1429504|NCT01013883|Secondary|Admission to Hospital for Any Cause|Number of patients admitted to the hospital will be recorded|During the follow up period of 7 years||||participants|||Number
1429505|NCT01013883|Secondary|Cardiovascular Mortality||Patients would be followed up for average of 7years||||participants|||Number
1429506|NCT01013883|Primary|All Cause Mortality||Patients would be followed up for average of 7 years||||participants|||Number
1429525|NCT01013753|Secondary|Total Asthma Quality of Life Questionnaire (AQLQ(s)) Score|Total score from the Standardised Asthma Quality of Life Questionnaire (AQLQ (s)) at the end of each 4 week treatment period. The AQLQ(s) contains 32 questions, each question has a 7 point scale from 1 (highest intensity) till 7 (no symptoms). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.|||units on a scale||Standard Error|Mean
1429526|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Nighttime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of patients|||Number
1429507|NCT01013870|Secondary|Symbol Digit Modalities Test - Written Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429508|NCT01013870|Secondary|Symbol Digit Modalities Test - Oral Score|The SDMT is a measure of divided attention, visual scanning and motor speed. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The subject is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the subject fills in the numbers that correspond to the symbols. In the oral version the examiner records the numbers spoken by the subject. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429509|NCT01013870|Secondary|Brief Visuospatial Memory Test - Revised|The BVMT-R is a measure of visuospatial memory. Six equivalent, alternate stimulus forms consist of six geometric figures printed in a 2 x 3 array on separate pages. In three Learning Trials, the subject views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Scoring of the immediate and delayed recall are based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial.|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429510|NCT01013870|Secondary|Center for Epidemiological Study Depression Scale|The CES-D is a widely used screening scale for depression, assessing depressive feelings and behaviors occurring in the past week of a patient’s life. The CES-D consists of 20 items, which make up six scales reflecting depressive symptomatology: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Each item is scored on a 4-point scale ranging from 0 (rarely/none of the time) to 3 (most/all of the time). Scores for items 4, 8, 12, and 16 are reversed before summing all items to yield a total score, which can range from 0-60. Higher scores indicate more depressive symptoms. (Radloff, LS [1977]. The CES-D Scale: A self-report depression scale for research in the general population. App Psychol Meas, 1, 385-401.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429511|NCT01013870|Secondary|Connor Davidson Resilience Measure|The Connor-Davidson Resilience scale (CD-RISC) has 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience. The sum score has a range from 0 to 100. (Conner KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale [CD-RISC]. Depress Anxiety 18[2]:76-82,2003].|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429512|NCT01013870|Secondary|Post-traumatic Stress Checklist - Civilian Form|The Post Traumatic Stress Disorder Checklist (PCL) is a 17-item self report measure of the DSM-IV symptoms of PTSD. Respondents rate how much they were “bothered by a symptom” on a 5-point scale ranging from 1 (“not at all”) to 5 (“extremely”). The PCL was scored as a total score (range 17-85), with higher total scores indicating more symptoms. (Weathers, F., Litz, B., Herman, D., Huska, J., & Keane, T. [October 1993]. The PTSD Checklist [PCL]: Reliability, Validity, and Diagnostic Utility. Paper presented at the Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429527|NCT01013753|Secondary|Number of Patients Categorized by Worst Asthma Daytime Symptoms (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of patients|||Number
1429528|NCT01013753|Secondary|Number of Patients Categorized by Highest Number of Night Time Awakenings (Overall)|Assessed by patients at home using the AM2+ device after the first 2 weeks of each period of randomised treatment.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of patients|||Number
1429730|NCT01012167|Secondary|Laboratory Measures - LDL|Low-density lipoprotein (LDL) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1429513|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Physical Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429514|NCT01013870|Secondary|Medical Outcome Study Short Form 12 - Mental Score|SF-12 is a self-report questionnaire that assesses functional health and well-being. There are 12 items in 8 subscales, including physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Physical and Mental Health Composite Scores are computed using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. (Ware, J.E., Jr., Kosinski, M., Turner-Bowker, D.M., Gandek, B. How to Score Version 2 of the SF-12v2® Health Survey [With a Supplement Documenting SF-12® Health Survey] Lincoln, RI: QualityMetric Incorporated, 2002.)|3 months|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Inter-Quartile Range|Median
1429515|NCT01013870|Primary|Rivermead Post-Concussion Symptoms Questionnaire, at 3 Months After Injury.|The Rivermead Post-Concussive Symptoms Questionnaire (RPQ) is a 16-item self-report measure of the presence and severity of the 16 most commonly reported post-concussive symptoms found in the literature. The scale compares any current symptoms to pre-injury symptom levels to account for potential symptom exacerbation due to TBI. The range of scores is 0-64. Values for each of the 16 items include 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), 4 (severe problem). The total score was a summation of symptoms that represented new symptom onset or an exacerbation of a symptom present pre-injury. (King, N.S., Crawford, S., Wenden, F.J., Moss, N.E., & Wade, D.T. [1995]. The Rivermead Post Concussion Symptoms Questionnaire: A Measure of Symptoms Commonly Experiences after Head Injury and its Reliability. Journal of Neurology 242: 587-92.)|3 months after injury|The analysis population includes all 27 patients in the atorvastatin group who completed the study and the 21 placebo group patients who completed the study plus one lost to follow-up at 6 months but had completed all of the outcome assessments for the primary and secondary outcomes at 3 months (for a total of 22 placebo group patients).|||units on a scale||Full Range|Median
1429516|NCT01013844|Primary|Mean Number of Times Reviewed Skin Self Examination Guidelines Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants reviewed skin self examination guidelines in the last 4 months.|4 months||||Number of times reviewed SSE guidelines||Standard Deviation|Mean
1429517|NCT01013844|Primary|Mean Number of Skin Examinations With Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin with a partner in the last 4 months.|4 months||||Times examined skin with a partner||Standard Deviation|Mean
1429518|NCT01013844|Primary|Mean Number of Skin Examinations Without Partner Over 4 Months|Behavioral outcome was measured by assessing the number of times that participants examined their skin in the last 4 months.|4 months||||Times examined skin by self||Standard Deviation|Mean
1429519|NCT01013792|Primary|Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit|A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.|up to 8 weeks|All participants that are randomized|||percent change of baseline area||Full Range|Median
1429520|NCT01013753|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|4 weeks|Treated Set|||Participants|||Number
1429521|NCT01013753|Secondary|Potassium 3 Hours Post-dose|Effect on potassium evaluated 3 hours post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set|||mmol/L||95% Confidence Interval|Geometric Mean
1429522|NCT01013753|Secondary|Potassium 1 Hour Post-dose|Effect on potassium evaluated 1 hour post-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set|||mmol/L||95% Confidence Interval|Geometric Mean
1429523|NCT01013753|Secondary|Potassium 1 Hour Pre-dose|Effect on potassium evaluated 1 hour pre-dose. Analysis is based on the log of the potassium values. For the geometric means, the results were back-transformed to the original scale.|4 weeks|Treated set|||mmol/L||95% Confidence Interval|Geometric Mean
1429524|NCT01013753|Secondary|Total Asthma Control Questionnaire (ACQ) Score|Control of asthma as assessed by the ACQ at the end of each 4-week treatment period.The ACQ contains 7 questions, each question has a 7 point scale from 0 (no symptoms) till 6 (highest intensity). Total score was defined as the sum of all items divided by the number of items.|4 weeks|FAS including all patients who contributed data for this endpoint.|||units on a scale||Standard Error|Mean
1429669|NCT01012245|Secondary|Visual Impairment Due to Glaucoma|Number of subjects per level of visual impairment categorized as not at all (no impairment), a little bit, moderate, severe, and very severe (very severe impairment).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups|||participants|||Number
1429529|NCT01013753|Secondary|Percentage of Asthma Symptom Free Days|Percentage of asthma-symptom free days after the first 2 weeks of each treatment period was calculated as the number of symptom-free days divided by the number of days on treatment multiplied by 100. A symptom-free day was defined as a day in which no asthma symptoms were recorded, no rescue medication was recorded, activities during the day were not at all limited due to asthma, no shortness of breath during the day was recorded, no wheezing or coughing during the day and no night-time awakenings due to asthma were recorded. Assessed by patients at home using the AM2+ device.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Percentage of asthma symptom free days||Standard Error|Mean
1429530|NCT01013753|Secondary|Mean Number of Puffs of Rescue Medication During the Whole Day|Mean of daily use of salbutamol (albuterol) rescue medication as needed during the entire study period. Assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Number of Puffs||Standard Error|Mean
1429531|NCT01013753|Secondary|Mean Pre-dose Evening FEV1 (FEV1 p.m.)|FEV1 p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||L||Standard Error|Mean
1429532|NCT01013753|Secondary|Mean Pre-dose Morning FEV1 (FEV1 a.m.)|FEV1 a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||L||Standard Error|Mean
1429533|NCT01013753|Secondary|PEF Daily Variability|PEF daily variability was assessed by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). PEF daily variability is the absolute difference between the morning and the evening PEF value divided by the mean of these two values, expressed as a percent. Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Percentage||Standard Error|Mean
1429534|NCT01013753|Secondary|Mean Pre-dose Evening PEF (PEF p.m.)|PEF p.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Liter/min||Standard Error|Mean
1429535|NCT01013753|Secondary|Mean Pre-dose Morning PEF (PEF a.m.)|PEF a.m. was measured by patients at home using the AM2+ device (overall means obtained during each period of randomised treatment excluding the data of the first 2 weeks will be compared). Means are adjusted for treatment, period, patient and study baseline.|2-4 weeks|FAS including all patients who contributed data for this endpoint.|||Liter/min||Standard Error|Mean
1429536|NCT01013753|Secondary|Trough PEF Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
1429537|NCT01013753|Secondary|Peak PEF Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Peak PEF within 24 hours post-dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
1429538|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
1429539|NCT01013753|Secondary|PEF Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
1429540|NCT01013753|Secondary|Peak Expiratory Flow (PEF) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline PEF was defined as the mean of the available pre-dose PEF values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. PEF AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres/seconds.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS|||Liter/sec||Standard Error|Mean
1429564|NCT01013597|Secondary|Impact of LBH589 on Tumor Markers for Thyroid Cancer|Change in serum Thyroglobulin level from baseline to end of treatment. Treatment continued until either extraordinary medical circumstances, disease progression, toxicity, subject withdrawal, or death. At the time subjects came off of study treatment for one of the reasons already listed, a sample was collected for tumor markers.|Baseline and end of treatment, up to 1 year||||ng/mL||Standard Deviation|Mean
1429541|NCT01013753|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429542|NCT01013753|Secondary|Peak FVC Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC within 24 hours post dose measured following the trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429543|NCT01013753|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 min, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429544|NCT01013753|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429545|NCT01013753|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h , 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429546|NCT01013753|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were defined as the mean of 2 FEV1 values performed at the planned timepoints 23h and 23h 50min related to evening trial-drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429547|NCT01013753|Secondary|Peak FEV1 Within 24 Hours Post-dose Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak FEV1 within 24 hours post dose measured following the evening trial drug inhalation at the end of each 4 week period of randomised treatment. Means are adjusted for treatment, period, patient and study baseline.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429548|NCT01013753|Secondary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429549|NCT01013753|Secondary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min related to evening dose after 4 weeks|FAS|||Liter||Standard Error|Mean
1429550|NCT01013753|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 Hours (AUC 0-24h) Response at the End of Each Treatment Period|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -1 h, -10 mins, 30 min, 60 min, 2 h, 3 h, 4 h, 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose after 4 weeks|Full analysis set (FAS). FAS is defined as all patients in the treated set for whom the baseline (pre-dose) value is available, and who have a value for the primary endpoint for at least one crossover period.|||Liter||Standard Error|Mean
1429565|NCT01013597|Secondary|Overall Survival|For a given patient, overall survival (OS) is defined as the number of days from the day of first LBH589 administration until the patient’s death. If a patient was alive at the time of analysis, then the patient’s data is censored at the date of the last available evaluation.Survival was assessed every three months until death or final data analysis, whichever occurred first.|Every 3 months up to 5 years||||months||95% Confidence Interval|Median
1429551|NCT01013740|Secondary|Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE.|From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)|Safety Population: participants who received at least one dose of study medication, based on the actual treatment received|||participants|||Number
1429552|NCT01013740|Secondary|Maximum Concentration (Cmax) for Vinorelbine|Cmax is defined as the maximum observed plasma or serum concentration after administration of the drug. PK parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose|||||||
1429553|NCT01013740|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC-tau) for Vinorelbine|AUC-tau is defined as the area under the concentration-time curve over a dosing interval at steady state, where tau is the length of the dosing interval. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. Pharmacokinetic (PK) parameters were to be assessed in an optional sub-study. No participants were enrolled in this optional sub-study; thus, no PK data are available.|Days 1 and 8; 0 to 24 hours post-dose|||||||
1429554|NCT01013740|Secondary|Number of Participants With Clinical Benefit (CB) in the Randomized Phase|CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population|||participants|||Number
1429555|NCT01013740|Secondary|Time to Response in the Randomized Phase|Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for time to response.|||weeks||95% Confidence Interval|Median
1429556|NCT01013740|Secondary|Duration of Response (DOR) in the Randomized Phase|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)|ITT Population. Only participants with a confirmed CR or PR were assessed for duration of response.|||months||95% Confidence Interval|Median
1429557|NCT01013740|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|From the date of randomization until death (average of 55 study weeks)|ITT Population|||months||95% Confidence Interval|Median
1429558|NCT01013740|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population|||participants|||Number
1429559|NCT01013740|Primary|Progression Free Survival (PFS) in the Randomized Phase|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion.|From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)|ITT Population: participants who were randomized to study treatment, regardless of whether they actually received study medication|||months||95% Confidence Interval|Median
1429560|NCT01013701|Secondary|To Evaluate the Efficacy and Safety of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray in Suppressing the Signs of Recurrence of Nasal Polyps Over the Course of 16 Weeks.||18 weeks|No data was collected/is available for the study as it was terminated prematurely and the PI has since left the institution.||||||
1429561|NCT01013701|Primary|To Evaluate the Effect of Once Daily Nasal Steroid Therapy With Fluticasone Furoate Nasal Spray (110 mcg/Day) in Suppressing Nasal Polyp-induced Symptoms Over the Course of 16 Weeks in Patients Presenting to the Clinic With Active Nasal Polypoid Disease.||18 weeks|The PI has left the institution and neither he, nor the data if any, is available. All information provided has been obtained from the Johns Hopkins University School of Medicine Institutional Review Board.||||||
1429562|NCT01013597|Secondary|Tolerability of LBH589|Tolerability and toxicity were not assessed separately, therefore tolerability is reported as toxicity.|Every 4 weeks, up to 5 years|||||||
1429563|NCT01013597|Secondary|Toxicity of LBH589|Most frequent toxicities at least possibly related to panobinostat, grades 2-4 (grading based on NCI common terminology criteria for adverse events CTCAE version 3). Toxicities were collected from the time the patient provided informed consent until 4 weeks after the patient stopped LBH589.|Every 4 weeks, up to 5 years||||participants|||Number
1429566|NCT01013597|Secondary|Time to Progression of Thyroid Cancer|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Time to progression is defined as the number of days from the day of first LBH589 administration to the day the patient experienced an event of disease progression or death, whichever came first. Progression was assessed every 3 months until death or up to 5 years, whichever occurred first.|Every 3 months until progression up to 5 years||||months||95% Confidence Interval|Median
1429567|NCT01013597|Secondary|Protein Expression Patterns of Notch1 in Thyroid Tissue Samples.||End of study|Notch1 protein expression was not measured due to lack of efficiency of study intervention||||||
1429568|NCT01013597|Primary|Tumor Response Rate to LBH589.|"per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT/MRI: Response includes Complete Response (CR, disappearance of all target lesions), or Partial Response (PR, >=30% decrease in the sum of the longest diameter of target lesions). No Response includes Stable Disease (SD, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease), and Progressive Disease (PD, at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).)"|Every 8 weeks.||||participants|||Number
1429569|NCT01013207|Secondary|Usability of the Nexus (S9) CPAP.|The usability quesitonnaire was administered at the end of the 4 week trial of Nexus (S9). Usability was defined as ease of using the Nexus (S9) and overall satisfaction with the Nexus (S9) CPAP. The outcome measure was collected through 11 point Likert questionnaires, where 0 = very poor usability and 10 = excellent usability.|4 weeks||||Units on a scale||Standard Deviation|Mean
1429570|NCT01013207|Primary|Compliance on CPAP|Compliance on CPAP was measured as average daily usage|12 weeks||||Hours||Standard Deviation|Mean
1429571|NCT01013194|Secondary|Analysis of Meld Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Meld score.~The Model for End-stage Liver Disease (MELD) scoring system aims at stratifying recipients by their disease severity according to a score estimating the 3-month probability of death on the waiting list. The calculation of an individual’s MELD score is based on three objective lab parameters (bilirubin, serum creatinine and prothrombin time expressed as international normalized ratio, INR) and it includes logarithmic transformations and multiplication by several factors. It ranges between 6 and 40. The highest is the score the lower is the patient’s survival."|Baseline and 1 year Follow-up||||units on a scale||Standard Deviation|Mean
1429572|NCT01013194|Secondary|Analysis of Child-Pugh Score From Baseline to 1 Year Follow-up|"Assessment of the efficacy of human fetal liver progenitor cell transplantation on Child-Pugh score.~The Child-Pugh (CP) classification is a scoring system used for the classification of the severity of cirrhosis. It includes three continuous variables (bilirubin, albumin and INR) and two discrete variables (ascites and encephalopathy). Each variable is scored 1-3 with 3 indicating most severe derangement. The determination of CP score may range from 5 to 15 and the final score allows to categorize patients in Child–Pugh A (5–6 points), B (7–9 points) and C (10–15 points). The highest is the score the sickest is the patient."|Baseline and 1 year Follow-up|Baseline Child-Pugh score vs Follow-up|||units on a scale||Standard Deviation|Mean
1429573|NCT01013194|Primary|Patient Survival|Assessment of treated and control patients survival at 1 year follow-up|1 year||||participants|||Number
1429574|NCT01012999|Primary|Pain Relief at Thirty Minutes|Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).|30 min post dose||||Units on a scale||Standard Deviation|Mean
1429575|NCT01012973|Secondary|Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF|EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||Scores on a scale||Standard Deviation|Mean
1429576|NCT01012973|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight|Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||Scores on a scale||Standard Deviation|Mean
1429577|NCT01012973|Secondary|Percentage of Participants Who Developed Neovascularization During the First 24 Weeks|Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24|From baseline until Week 24|Full analysis set|||Percentage of participants|||Number
1429578|NCT01012973|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and Week 24|Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF|||microns||Standard Deviation|Mean
1429579|NCT01012973|Secondary|Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.|Baseline and Week 24|Full analysis set|||Letters correctly read||Standard Deviation|Mean
1429580|NCT01012973|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures|Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.|Baseline and Week 24|Full analysis set|||Percentage of participants|||Number
1429697|NCT01012167|Secondary|Side Effect Checklist (SEC) - Stiffness|"Percentage of participants with new onset or worsening compared to baseline of Stiffness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429581|NCT01012947|Primary|Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group|"The mini–mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It ranges from 0 to 30 points. The higher scores mean better outcome. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment.~In the time span of about 10 minutes it samples various functions including arithmetic, memory and orientation."|baseline and 18 months|The location of the survey was Suwon City, with a population of 1 million, located adjacent to Seoul, the nation's capital. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.|||units on a scale||Standard Deviation|Mean
1429582|NCT01012921|Primary|The Bone Fill Was Assessed at 6 Months After Regenerative Therapy.|Change between baseline (regenerative therapy) and the 6 months timepoint is reported.|Assessed at 6 months reported|PP|||mm||Standard Deviation|Mean
1429583|NCT01012765|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 20 days were included in the analysis.|||Liters||95% Confidence Interval|Least Squares Mean
1429584|NCT01012765|Secondary|FEV1 30 Minutes Post-dose After 21 Days of Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.|||Liters||95% Confidence Interval|Least Squares Mean
1429585|NCT01012765|Secondary|Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment|Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.|||kPa*sec||95% Confidence Interval|Least Squares Mean
1429586|NCT01012765|Secondary|Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment|Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.|||Ratio||95% Confidence Interval|Least Squares Mean
1429587|NCT01012765|Secondary|Peak Total Lung Capacity (TLC) After 21 Days of Treatment|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.|||Liters||95% Confidence Interval|Least Squares Mean
1429588|NCT01012765|Secondary|Peak Residual Volume (RV) After 21 Days of Treatment|Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis.|||Liters||95% Confidence Interval|Least Squares Mean
1429589|NCT01012765|Secondary|Trough IC After 20 Days of Treatment|Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|20 days|Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 20 days were included in this analysis.|||Liters||95% Confidence Interval|Least Squares Mean
1429590|NCT01012765|Primary|Peak Inspiratory Capacity (IC) After 21 Days of Treatment|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.|21 days|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis.|||Liters||95% Confidence Interval|Least Squares Mean
1429620|NCT01012622|Primary|Change From Baseline in Korean Version of the Attention-Deficit Hyperactivity Disorder (K-ADHD) Rating Scale (K-ARS) Total Score at Week 12|K-ARS measures the 18 symptoms based on Diagnostic and Statistical Manual of Mental Disorders-forth edition (DSM-IV 1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Baseline and Week 12|Intention-to-treat (ITT) population included participants who received the study drug at least once and had the primary efficacy endpoint data available|||units on a scale||Standard Deviation|Mean
1429591|NCT01012739|Secondary|Indacaterol Exposure (Cmax) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.|||pg/mL||Standard Deviation|Mean
1429592|NCT01012739|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment|All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data using non-compartmental analysis.|0 to 24 hours post-dose|Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.|||pg*hr/mL||Standard Deviation|Mean
1429593|NCT01012739|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|From 5 minutes to 4 hours post-dose for each treatment|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||Standard Deviation|Mean
1429594|NCT01012739|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|From 5 minutes to 12 hours post-dose|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Hours||Standard Deviation|Mean
1429595|NCT01012739|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||Standard Deviation|Mean
1429596|NCT01012739|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.|Baseline and Day 1|Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||Standard Deviation|Mean
1429597|NCT01012713|Secondary|A Tertiary Endpoint Will be the Percentage of Patients Achieving 90% Reduction in Psoriasis Area and Severity Index at Week 12.||12 weeks||||percent||95% Confidence Interval|Number
1429598|NCT01012713|Secondary|The Secondary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in Psoriasis Area and Severity Index at Weeks 4 and 8.||8 weeks||||percent||95% Confidence Interval|Number
1429599|NCT01012713|Primary|The Primary Endpoint Will be the Percentage of Patients Achieving a 75% Reduction in the Psoriasis Area and Severity Index at Week 12.||12 weeks||||percent||95% Confidence Interval|Number
1429600|NCT01012674|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2 - 42 days||||percentage of arterial segments|Participants|95% Confidence Interval|Number
1429601|NCT01012674|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).|2-42 days||||percentage of arterial segments|Participants|95% Confidence Interval|Number
1429602|NCT01012674|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).|2 - 28 days||||percentage of arterial segments|Participants|95% Confidence Interval|Number
1429603|NCT01012661|Primary|Patients With Clinically Significant Reduction in Pain|Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with >/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)||||Participants|||Number
1429604|NCT01012661|Primary|Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)|Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).|Immediately after injection (Time 0)||||cm||Standard Deviation|Mean
1429621|NCT01012492|Secondary|Protective Immunity||3 years after transplant|||||||
1429622|NCT01012492|Secondary|Immunology||3 years|||||||
1429623|NCT01012492|Secondary|Percentage of Participants With Grades III-IV Acute GVHD at 2 Years|The rates of Grades III-IV acute GVHD were measured at 2 years according to standard Glucksberg criteria, which was 10%.|2 years after transplant||||percentage of participants|||Number
1429624|NCT01012492|Primary|Percentage of Participants With Grade III-IV Acute GVHD by Day 100.|Grade III-IV Acute GVHD by Day 100. The incidence of Gr III-IV acute GVHD was measured by the modified Glucksburg scale.|Day 100 post-transplant||||percentage of participants|||Number
1429605|NCT01012622|Secondary|Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 12|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Improved very much, Improved much and Improved a little are defined as improvement and No change, Aggravated a little, Aggravated much and Aggravated very much were defined as aggravation.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||participants|||Number
1429606|NCT01012622|Secondary|Change From Baseline in Clinical Global Impression-severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used.|||units on a scale||Standard Deviation|Mean
1429607|NCT01012622|Secondary|Change From Baseline in Parenting Stress Index (PSI) Total Score at Week 12|Parenting Stress Index (PSI) was designed to assess parent or guardian child-rearing stress index on a 5-rating scale from ”never” to “very truly”. Out of 30 items, 20 items are scored, being consisted of 8 child characteristics-related stress items; 9 parent-child interaction-related stress items; and 3 achievement expectation-related stress items. A possible total score ranges from 20 to 100; Increase in score indicates higher stress perceived by the parent.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429608|NCT01012622|Secondary|Change From Baseline in Beck Depression Inventory (BDI) Score at Week 12|Beck Depression Inventory (BDI) consisted of 21 items for measuring the subjective severity of depression and emotional, cognitive, motivational, physiological symptoms of depression. Each question has a set of 4 possible answer choices, ranging in intensity, each answer being scored on a scale value of 0 (no symptom) to 3 (the most severe symptom). Accordingly, the total score ranges from 0 (no symptom) to 63 (the most severe symptom) for 21 questions.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429609|NCT01012622|Secondary|Change From Baseline in Academic Performance Rating Scale (APRS) Score at Week 12|APRS scale measures four factors in elementary school children such as learning ability, academic performance, impulse control, and social withdrawal. In particular, it is excellent in assessing drug effect on the academic performance not measured by other scales. Score ranges from 19 to 95, higher score means better academic performance.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429610|NCT01012622|Secondary|Change From Baseline in Working Memory Backward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the backward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||correct responses||Standard Deviation|Mean
1429611|NCT01012622|Secondary|Change From Baseline in Working Memory Forward Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. The test battery provided a comprehensive measurement of simple visual auditory attention, interventional visual-auditory selective attention, divided attention, continuous attention, and operational memory. Working memory forward was measured in terms of width of space and number of correct responses ranging from 0 to 10. For width of space boxes were presented on the screen and participants remembered the order of presented box. Participants pressed the box using mouse in the forward order. Maximum number that participants correctly memorized box in the screen in the respective order was reported and overall number of times a participant responded correctly was also reported.|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||correct responses||Standard Deviation|Mean
1429612|NCT01012622|Secondary|Change From Baseline in Divided Attention Subtest of Comprehensive Attention Test (CAT) at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple divided attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429613|NCT01012622|Secondary|Change From Baseline in Interference-Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple interference-selective attention in terms of omission(number of missing response to target stimulus[0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus[0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429614|NCT01012622|Secondary|Change From Baseline in Inhibition-Sustained Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple inhibition-sustained attention in terms of omission(number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm(number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429615|NCT01012622|Secondary|Change From Baseline in Auditory Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple auditory selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429616|NCT01012622|Secondary|Change From Baseline in Visual Selective Attention Subtest of Comprehensive Attention Test (CAT) Total Score at Week 12|CAT was developed to properly reflect brain function in childhood. It provided measurement of simple visual selective attention in terms of omission (number of missing response to target stimulus [0-150], higher score indicate greater omission), false alarm (number of response to non-target stimulus [0-150], higher score indicate greater false alarm), response mean (average time spent to response to target stimulus [200-1100, low score means faster response to target stimulus]), Response (consistency of response time to target stimulus [30-650, Low score means good consistency of response]).|Baseline and Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. LOCF method was used. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1429617|NCT01012622|Secondary|Change From Baseline in Child Health and Illness Profile-Child Edition (CHIP) Total Score and 5 Sub-domains Score at Week 12|CHIP was designed to assess the physical, psychological health conditions and functional well-being of children. The instrument has sub-domains such satisfaction (11 items) ranges from 0 to 44, stability (22 items) ranges from 0 to 88, elasticity (19 items) ranges from 0 to 76, risk aversion (14 items) ranges from 0 to 56, achievement (10 items) ranges from 0 to 40. Good health is in the range from 44 to 56 points for all sub-domains. A score of 43 or below indicates poor health in that domain. A score of 57 or higher indicates excellent health. The total score is an average of the scores for the 5 domains and ranges from 0 to 304. Higher total score indicates better health.|Baseline and Week 12|"ITT population included participants who took study drug at least once and had primary efficacy endpoint data available. Last Observation Carried Forward (LOCF) method was used. n signifies participants who were evaluated for each specified category for this measure."|||units on a scale||Standard Deviation|Mean
1429618|NCT01012622|Primary|Number of Participants With Remission Based on K-ARS Total Score and Clinical Global Impression – Improvement (CGI-I) Scale Score at Week 12|Remission is defined by all of the following criteria; 1) K-ARS Total score of 18 or less. 2) “Very much improved” or “Much improved” in CGI-I. K-ARS total score ranges from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition. CGI-I is a 7-point scale ranging from 1 to 7, where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse, higher score indicates worsening of condition.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||participants|||Number
1429619|NCT01012622|Primary|Number of Participants With Response Based on K-ARS Total Score at Week 12|Response is defined as at least 25 percent (%) decrease in total score of K-ARS compared to baseline. K-ARS measures the 18 symptoms based on DSM-IV (1994). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), whereas the rating of 2 points or more was regarded as abnormal. Total scores range from 0 (no symptoms) to 54 (highly symptomatic), higher score indicates worsening of condition.|Week 12|ITT population included participants who received the study drug at least once and had the primary efficacy endpoint data available. “N” (Number of Participants Analyzed) represents number of participants who were evaluable for this outcome measure.|||participants|||Number
1429625|NCT01012440|Primary|Reduction in Tumor Size|Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.|1-2 weeks post treatment onset|This study has been terminated due to poor accrual.|||mm||Standard Deviation|Mean
1429630|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|6 months||||participants|||Number
1429631|NCT01012388|Primary|Number Participants With Hypertropic Scarring, Keloid Formation, Hyper- or Hypopigmentation in Patients With Fitzpatrick Skin Types IV, V, and VI Receiving Nasolabial Fold Treatment|Skin type IV - Burns minimally, tans moderately and easily, Skin type V - Rarely burns, tans profusely; Skin type VI - Never burns, tans profusely|3 months||||Participants|||Number
1429632|NCT01012362|Secondary|Number of Participants With Treatment-Related Adverse Events|Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.|Up to 30 days post treatment|Dose Level 3 includes participants from Arm 1: Dose Level 3 and Arm 2 combined.|||Participants|||Count of Participants
1429633|NCT01012362|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)|A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for >7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding >/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by >2 weeks due to incomplete hematologic recovery (absolute neutrophil count > 1.5 X 10^9/L or platelets >100 X 10^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).|Week 3 of each dose|6 participants were included at Dose Level 1 to confirm safety after escalation to Dose level 2, but are grouped with the original 3 participants enrolled at Dose Level 1.|||Participants|||Count of Participants
1429634|NCT01012362|Primary|The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination|The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for > 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC > 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.|Week 3 of each dose level||||Dose Level|||Number
1429635|NCT01012336|Secondary|Time to First Vomiting Episode or Use of Rescue Medication||120 hours|||||||
1429636|NCT01012336|Secondary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy||120 hours|||||||
1429637|NCT01012336|Primary|Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen||120 hours|||||||
1429638|NCT01012336|Primary|Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.|Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).|120 hours||||Percentage of Participants|||Number
1429639|NCT01012323|Secondary|Changes in the Physical and Mental Short Form-36 Health Survey Scores From Baseline to the End of the Study|The Quality of Life (QoL) questionnaire Short Form-36 Health Survey (SF-36-HS) was completed by participants ≥ 14 years of age. The SF-36-HS consists of 36 items organized into 8 subscales. The 8 subscales could be combined into 2 summary scores, physical and mental. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates better health. A positive change score indicates improvement.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Units on a scale||Standard Deviation|Mean
1429640|NCT01012323|Secondary|Changes in the Physical and Psychosocial Child Health Questionnaire-Parent Form Scores From Baseline to the End of the Study|The Quality of Life (QoL) questionnaire Child Health Questionnaire-Parent Form (CHQ-PF50) was completed by a parent or guardian in study participants < 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates more positive functioning or better health status. A positive change score indicates improvement.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Units on a scale||Standard Deviation|Mean
1429641|NCT01012323|Secondary|Percentage of Participants That Missed School or Work Due to an Infection||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Percentage of participants|||Number
1429642|NCT01012323|Secondary|Percentage of Participants With at Least 1 Episode of Fever||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Percentage of participants|||Number
1429643|NCT01012323|Secondary|Number of Participants Hospitalized Due to an Infection||Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Participants|||Number
1429644|NCT01012323|Secondary|Number of Antibiotic Treatment Days Per Person-year of Treatment|The number of antibiotic treatment days per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment days / patient-years of NewGam treatment.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Treatment days/person/year|||Number
1429645|NCT01012323|Secondary|Number of Antibiotic Treatment Episodes Per Person-year of Treatment|The number of antibiotic treatment episodes per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment episodes / patient-years of NewGam treatment.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Treatment episodes/person/year|||Number
1429646|NCT01012323|Secondary|Percentage of Participants Treated With Antibiotics|The total percentage of participants treated with antibiotics, as well as, the percentage of participants treated with antibiotics therapeutically and prophylactically are reported.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Percentage of participants|||Number
1429647|NCT01012323|Secondary|Time to Resolution of Serious and Other Infections|Since infections were reported as adverse events, the time to resolution of an infection was the time from the start date of the infection adverse event to the end date of the infection adverse event.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Days||Standard Deviation|Mean
1429648|NCT01012323|Secondary|Number of Non-serious Infections|The MedDRA preferred term was used to determine the type of non-serious infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. The total number of infections and the number in each category are reported.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Infections|||Number
1429649|NCT01012323|Secondary|Total Number of Infections|The number of infections included serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, osteomyelitis/septic arthritis, visceral abscess, bacterial meningitis) and other infections. For other infections, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term was used to determine the type of infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Infections|||Number
1429650|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Varicella-zoster Virus|Trough level concentrations of antibodies against varicella-zoster virus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||U/mL||Standard Deviation|Mean
1429651|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Tetanus|Trough level concentrations of antibodies against tetanus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||IU/mL||Standard Deviation|Mean
1429652|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Cytomegalovirus|Trough level concentrations of antibodies against cytomegalovirus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||U||Standard Deviation|Mean
1429653|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae|Trough level concentrations of antibodies against Streptococcus pneumoniae (serotypes types 6B, 14, 9V, 18C, 19F, 4, and 23F) were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||µg/mL||Standard Deviation|Mean
1429654|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Measles|Trough level concentrations of antibodies against measles were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||mIU/mL||Standard Deviation|Mean
1429655|NCT01012323|Secondary|Trough Level Concentration of Antibodies Against Haemophilus Influenzae|Trough level concentrations of antibodies against Haemophilus influenzae were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.|Baseline to end of the study (up to 12 months)|Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels.|||µg/mL||Standard Deviation|Mean
1429657|NCT01012323|Primary|Number of Serious Bacterial Infections Per Person-year of Treatment|The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess.|Baseline to end of the study (up to 12 months)|Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry.|||Serious infections per person-year of tr|||Number
1429658|NCT01012297|Secondary|Objective Response Rate as Measured by RECIST 1.1 Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 5 years|All randomized|||percentage of participants||95% Confidence Interval|Number
1429659|NCT01012297|Secondary|Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0|"Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse.~Please refer to the adverse event reporting for more detail."|Up to 5 years|All randomized.|||Participants|||Count of Participants
1429660|NCT01012297|Secondary|Overall Survival|"Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan.~The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group."|Up to 5 years|All randomized|||months||95% Confidence Interval|Median
1429661|NCT01012297|Primary|Progression-free Survival|"Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan.~Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months|All randomized|||months||95% Confidence Interval|Median
1429662|NCT01012258|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the duration (in months) from first administration of trial treatment to first observation of PD (radiological or clinical, if radiological PD is not available), or death due to any cause. The PFS time of participants without observation of PD but death occurring after two or more missed consecutive tumor assessments (i.e. two-fold scheduled time interval of two consecutive tumor assessments) was censored on the date of last tumor assessment or first administration of trial treatment (whichever was later).|Baseline up to disease progression or withdrawal or 12 weeks after the last radiotherapy of the last participant|ITT population included all participants who received at least one dose of the IMP cetuximab or RT.|||months||95% Confidence Interval|Median
1429663|NCT01012258|Primary|Best Overall Response (BOR)|Best overall (objective) response was defined as the occurrence of complete response (CR) or partial response (PR) based on the investigator's assessment according to modified World Health Organization (WHO) criteria confirmed at a repeat assessment performed no less than 28 days after the criteria for response were first met. CR was defined as disappearance of all index lesions. PR was defined as a 50% or more decrease in the sum of the products of diameters (SOPD) of index lesions compared to the baseline SOPD, with no evidence of PD.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 3 months following the 8 weeks after the end of RT visit until the end of trial (EOT) visit|Intention-to-treat (ITT) population included all participants who received at least one dose of the investigational medicinal product (IMP) cetuximab or RT.|||percentage of participants||95% Confidence Interval|Number
1429664|NCT01012245|Secondary|Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment|Number of subjects with documented change to the color of the iris during treatment with Xalatan® or Xalacom®.|Baseline up to 3 years|Xalatan® treatment group (subjects with Xalatan® (latanoprost) monotherapy at baseline visit) and Xalacom® treatment group (latanoprost + timolol maleate) therapy at baseline visit. During the course of the study the data structure (scaling of color) was changed in a way that change in iris color was no longer evaluable; data not summarized.|||participants|||Number
1429665|NCT01012245|Secondary|Reasons for Discontinuation From Study|Number of subjects per reason for discontinuation from the study. More than one reason for discontinuation is possible per patient. Discontinuation analysis was performed independent of the duration of any individual subject's time on study.|January 2000 through December 2008|Subjects from the All subjects group population who discontinued the study.|||participants|||Number
1429666|NCT01012245|Secondary|Investigator Assessment of Tolerability of Xalatan® Treatment|Number of subjects for the Investigator's assessment of subjects tolerability of Xalatan® treatment categorized as excellent, very good, good, moderate, sufficient, or insufficient. The occurrence of adverse events (a side effect that may not have any causal relationship to study treatment) was documented as tolerability data.|Baseline up to 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).|||participants|||Number
1429667|NCT01012245|Secondary|Reasons for Changes in Glaucoma Therapy|Number of subjects for each reason for change of therapy; there may be more than one reason possible per patient. Reasons for changes in glaucoma therapy was reported from January 2000 through December 2008 independent of the duration of any individual subject's time on study.|January 2000 through December 2008|"Subjects from the all subjects group that changed therapy through the duration of the study; subjects who changed from or changed to other therapy (Other Medication) were not included in this analysis; not summarized by subgroups."|||participants|||Number
1429668|NCT01012245|Secondary|Subject Self-care: Application of Eye Drops|Number of subjects per level of ability for application (administration) of eye drops categorized as without the help of nursing staff (apply without help) and with the help of nursing staff (apply with help).|Baseline, 1 year, 2 years, and 3 years|All subjects group; not summarized by subgroups|||participants|||Number
1441650|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
1429670|NCT01012245|Secondary|Visual Acuity (Visus)|Number of subjects with visual acuity evaluations: amaurosis (partial or total loss of sight); hand movements (able to detect gross object and motion perception without detailed discrimination); finger count (able to count fingers at a given distance); visual acuity scale: range 0.05 (low acuity) to >1.2 (greater acuity). If values were given for both the right eye and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations|||participants|||Number
1429671|NCT01012245|Secondary|Subject Assessment of Satisfaction With Xalatan® Treatment|Number of subjects for assessment of subject satisfaction with Xalatan® treatment; categorized as excellent (full satisfaction), very good, good, moderate, sufficient, and insufficient (no satisfaction).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan monotherapy at baseline visit).|||participants|||Number
1429672|NCT01012245|Secondary|Investigator Assessment of Xalatan® Efficacy|Number of subjects for Investigator assessment of the efficacy of Xalatan® treatment rated as excellent (highly effective), very good, good, moderate, sufficient, and insufficient (not effective).|Baseline, 1 year, 2 years, and 3 years|Xalatan® treatment group only (subjects with Xalatan® monotherapy at baseline visit).|||participants|||Number
1429673|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio|Mean horizontal cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of subjects with optic disc excavation data at baseline; (n)=number of subjects with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.|||ratio||Standard Deviation|Mean
1429674|NCT01012245|Primary|Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio|Mean vertical cup to disc (cup/disc or C/D) ratio to assess the progression of glaucoma; calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc). If values were given for both right and left eye, the value of the right eye was analyzed. Change calculated as mean of (value of cup/disc ratio at observation minus baseline value).|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations. N=number of participants with optic disc excavation data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.|||ratio||Standard Deviation|Mean
1429675|NCT01012245|Primary|Aulhorn Stage (Visual Field Defects)|Number of subjects at each Aulhorn stage. Staged as: No scotoma; Stage I (relative scotomas only), Stage II (absolute scotomas without connection to the blind spot), Stage III (absolute scotomas with connection to the blind spot), Stage IV (absolute scotomas more than 1 quadrant affected), and Stage V (temporal residual visual field only). If values were given for both right and left eye, the value of the right eye was analyzed.|Baseline, 1 year, 2 years, and 3 years|All subjects group and all treatment groups populations|||participants|||Number
1429676|NCT01012245|Primary|Change From Baseline in Intraocular Pressure (IOP)|Mean IOP values measured by applanation tonometry. Only Goldman values are displayed; if values were given for both right and left eye, the value of the right eye was analyzed. Change (absolute difference) calculated as mean of (value of IOP at observation minus baseline value). Study course is reported by yearly intervals and clustered as 1 year (12±3 months), 2 years (24±3 months), and 3 years (36±3 months).|Baseline, 1 year, 2 years, and 3 years|All subjects group and each treatment group population. N=number of participants with IOP data at baseline; (n)=number of participants with analyzable data at observation for All subjects, Xalatan®, Betablockers, Xalacom®, and Other medications, respectively.|||mm Hg||Standard Deviation|Mean
1429677|NCT01012219|Primary|Cutaneous Bleeding Time (BT)|"Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days.~The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable.~Period 3 was not analyzed as bleeding time was not an objective for this part of the study."|Day 8|Due to technical reasons, bleeding time was zero for some participants; they were considered to be missing data. Therefore, these observations were excluded from the analysis.|||Seconds||95% Confidence Interval|Least Squares Mean
1429678|NCT01012167|Secondary|Willingness to Interact|"Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being definitely willing and 5 being definitely unwilling. The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
1429679|NCT01012167|Secondary|Reactions to Partner|"Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being completely agree and 5 being completely disagree. The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
1429680|NCT01012167|Secondary|Positive and Negative Affect Schedule (PANAS) - Positive|"Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
1429698|NCT01012167|Secondary|Side Effect Checklist (SEC) - Sore Throat|"Percentage of participants with new onset or worsening compared to baseline of Sore Throat rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429681|NCT01012167|Secondary|Positive and Negative Affect Schedule (PANAS) - Negative|"Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being very slightly or not at all and 5 being extremely. The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays."|Treatment Week 0 and Week 6|Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.|||units on a scale||Standard Deviation|Mean
1429682|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Working Memory|MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429683|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Visual Learning|MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test—Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429684|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Verbal Learning|MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test—Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429685|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Social Cognition|MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429686|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving|MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429687|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Processing Speed|MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429688|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Attention Vigilance|MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429689|NCT01012167|Secondary|Neurocognitive Assessment Battery (MCCB) - Composite Score|MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.|Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).|Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.|||units on a scale||Standard Deviation|Mean
1429690|NCT01012167|Secondary|Side Effect Checklist (SEC) - Wheezing|"Percentage of participants with new onset or worsening compared to baseline of Wheezing rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants with missing wheezing data."|||percentage of participants|||Number
1429691|NCT01012167|Secondary|Side Effect Checklist (SEC) - Weight Loss|"Percentage of participants with new onset or worsening compared to baseline of Weight Loss rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429692|NCT01012167|Secondary|Side Effect Checklist (SEC) - Vomiting|"Percentage of participants with new onset or worsening compared to baseline of Vomiting rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429693|NCT01012167|Secondary|Side Effect Checklist (SEC) - Uterine Contractions|"Percentage of participants with new onset or worsening compared to baseline of Uterine Contractions rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Female participants|||percentage of participants|||Number
1429694|NCT01012167|Secondary|Side Effect Checklist (SEC) - Urticaria|"Percentage of participants with new onset or worsening compared to baseline of Urticaria rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429695|NCT01012167|Secondary|Side Effect Checklist (SEC) - Tremor|"Percentage of participants with new onset or worsening compared to baseline of Tremor rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429696|NCT01012167|Secondary|Side Effect Checklist (SEC) - Tinnitus|"Percentage of participants with new onset or worsening compared to baseline of Tinnitus rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429700|NCT01012167|Secondary|Side Effect Checklist (SEC) - Restlessness|"Percentage of participants with new onset or worsening compared to baseline of Restlessness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429701|NCT01012167|Secondary|Side Effect Checklist (SEC) - Rash|"Percentage of participants with new onset or worsening compared to baseline of Rash rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429702|NCT01012167|Secondary|Side Effect Checklist (SEC) - Nausea|"Percentage of participants with new onset or worsening compared to baseline of Nausea rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429703|NCT01012167|Secondary|Side Effect Checklist (SEC) - Nasal Irritation|"Percentage of participants with new onset or worsening compared to baseline of Nasal Irritation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing nasal irritation data."|||percentage of participants|||Number
1429704|NCT01012167|Secondary|Side Effect Checklist (SEC) - Mucosal Ulceration|"Percentage of participants with new onset or worsening compared to baseline of Mucosal Ulceration rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429705|NCT01012167|Secondary|Side Effect Checklist (SEC) - Malaise|"Percentage of participants with new onset or worsening compared to baseline of Malaise rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429706|NCT01012167|Secondary|Side Effect Checklist (SEC) - Insomnia|"Percentage of participants with new onset or worsening compared to baseline of Insomnia rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429707|NCT01012167|Secondary|Side Effect Checklist (SEC) - Hypersalivation|"Percentage of participants with new onset or worsening compared to baseline of Hypersalivation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429708|NCT01012167|Secondary|Side Effect Checklist (SEC) - Hyperhydrosis|"Percentage of participants with new onset or worsening compared to baseline of Hyperhydrosis rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing Hyperhydrosis data."|||percentage of participants|||Number
1429709|NCT01012167|Secondary|Side Effect Checklist (SEC) - Headache|"Percentage of participants with new onset or worsening compared to baseline of Headache rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429710|NCT01012167|Secondary|Side Effect Checklist (SEC) - Fever|"Percentage of participants with new onset or worsening compared to baseline of Fever rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429711|NCT01012167|Secondary|Side Effect Checklist (SEC) - Excessive Tearing of the Eye|"Percentage of participants with new onset or worsening compared to baseline of Excessive Tearing of the Eye rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing excessive tearing of the eye data."|||percentage of participants|||Number
1429712|NCT01012167|Secondary|Side Effect Checklist (SEC) - Enuresis|"Percentage of participants with new onset or worsening compared to baseline of Enuresis rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429713|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dry Mouth|"Percentage of participants with new onset or worsening compared to baseline of Dry Mouth rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429714|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dry Eye|"Percentage of participants with new onset or worsening compared to baseline of Dry Eye rating on the SEC, by Treatment Group."|Weekly for 6 weeks|"Safety data for 56 participants exposed to study treatment minus 6 participants who had missing dry eye data."|||percentage of participants|||Number
1429715|NCT01012167|Secondary|Side Effect Checklist (SEC) - Dizziness|"Percentage of participants with new onset or worsening compared to baseline of Dizziness rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429716|NCT01012167|Secondary|Side Effect Checklist (SEC) - Diarrhea|"Percentage of participants with new onset or worsening compared to baseline of Diarrhea rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429717|NCT01012167|Secondary|Side Effect Checklist (SEC) - Constipation|"Percentage of participants with new onset or worsening compared to baseline of Constipation rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429718|NCT01012167|Secondary|Side Effect Checklist (SEC) - Bruising Easily|"Percentage of participants with new onset or worsening compared to baseline of Bruising Easily rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429719|NCT01012167|Secondary|Side Effect Checklist (SEC) - Anorexia|"Percentage of participants with new onset or worsening compared to baseline of Anorexia rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429720|NCT01012167|Secondary|Side Effect Checklist (SEC) - Abdominal Pain|"Percentage of participants with new onset or worsening compared to baseline of Abdominal Pain rating on the SEC, by Treatment Group."|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||percentage of participants|||Number
1429721|NCT01012167|Secondary|Laboratory Measures - BUN|BUN blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant data for Evaluation and Week 6.|||mg/dL||Standard Deviation|Mean
1429738|NCT01012167|Secondary|Laboratory Measures - Alkaline Phosphatase|Alkaline phosphatase blood level by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation at Week 6.|||U/L||Standard Deviation|Mean
1429739|NCT01012167|Secondary|Laboratory Measures - AST/SGOT|Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||U/L||Standard Deviation|Mean
1429740|NCT01012167|Secondary|Laboratory Measures - ALT/SGPT|Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.|Once during evaluation and once at the end of 6 weeks of study treatment|Available participant lab data at Evaluation and Week 6.|||U/L||Standard Deviation|Mean
1429741|NCT01012167|Secondary|Blood Oxytocin Levels|Blood Oxytocin Levels by Treatment and Visit|Treatment Week 0 and Week 6|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.|||pg/mL||Standard Deviation|Mean
1429742|NCT01012167|Secondary|Barnes Akathisia Scale (BAS) - Global Score|"For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from 0=Absent to 5=Severe Akathisia. Higher scores indicate a more severe global rating of akathisia."|Treatment Week 0 and Week 6|50 participants who completed the trial.|||percentage of participants|||Number
1429743|NCT01012167|Secondary|Electrocardiogram (EKG)|Mean corrected QT interval (QTc) by study week and treatment.|Once during Evaluation and once at Treatment Week 6|50 participants who completed the trial.|||QTc||Standard Deviation|Mean
1429744|NCT01012167|Secondary|Abnormal Involuntary Movement Scale (AIMS)|"AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from 0=None to 4=Severe. The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating."|Treatment Week 0 and Week 6|50 participants who completed the trial.|||percentage of participants|||Number
1429745|NCT01012167|Secondary|Simpson-Angus Scale (SAS)|"SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from 0=None/Normal to 4=Extreme/Severe. The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating."|Baseline, week 3, and week 6|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||percentage of participants|||Number
1429746|NCT01012167|Secondary|Vital Signs - Pulse|Mean sitting pulse (bpm) by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||bpm||Standard Deviation|Mean
1429747|NCT01012167|Secondary|Vital Signs - Weight|Mean weight (kg) by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||kg||Standard Deviation|Mean
1429748|NCT01012167|Secondary|Vital Signs - Systolic Blood Pressure|Mean systolic blood pressure by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||mm-Hg||Standard Deviation|Mean
1429749|NCT01012167|Secondary|Vital Signs - Diastolic Blood Pressure|Mean diastolic blood pressure by treatment and follow-up week|Weekly for 6 weeks|Safety data for 56 participants exposed to study treatment.|||mm-Hg||Standard Deviation|Mean
1429750|NCT01012167|Secondary|Arizona Sexual Experience Questionnaire (ASEX) Male|"Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences."|Once during evaluation and once at the end of 6 weeks of study treatment|Male participants who completed at least two weeks follow-up.|||units on a scale||Standard Deviation|Mean
1429751|NCT01012167|Secondary|Arizona Sexual Experience Questionnaire (ASEX) Female|"Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from 1=Easily/Extremely to 6=Never/None. The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences."|Once during evaluation and once at the end of 6 weeks of study treatment|Female participants who completed at least two weeks follow-up.|||units on a scale||Standard Deviation|Mean
1429752|NCT01012167|Secondary|Calgary Depression Scale (CDS) - Total Score|"Total score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating."|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
1429753|NCT01012167|Secondary|Brief Psychiatric Rating Scale (BPRS) - Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Every other week for 6 weeks|Safety data available for the 56 participants exposed to study treatment.|||units on a scale||Standard Deviation|Mean
1429754|NCT01012167|Secondary|Brief Psychiatric Rating Scale (BPRS) - Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Every other week for 6 weeks|Safety data available for 56 participants exposed to study treatment.|||units on a scale||Standard Deviation|Mean
1441651|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
1429755|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
1429756|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Alogia|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
1429757|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
1429758|NCT01012167|Secondary|Scale for the Assessment of Negative Symptoms (SANS) - Avolition|Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
1429759|NCT01012167|Primary|Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week|* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.|Treatment Week 0 and Week 6|Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.|||units on a scale||Standard Deviation|Mean
1429760|NCT01012167|Primary|Scale for the Assessment of Negative Symptoms (SANS) Total Score|Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Every other week for 6 weeks|Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.|||units on a scale||Standard Deviation|Mean
1429761|NCT01012089|Primary|Drug Clearance Due to Dialysis (CLdialysis)|The rate at which a drug substance is removed from the body due to dialysis therapy|0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mL/hr||Full Range|Mean
1429762|NCT01012089|Primary|Total Drug Clearance (CLtotal)|The rate at which a drug substance is removed from the body|0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mL/hr||Full Range|Mean
1429763|NCT01012089|Primary|Elimination Rate Constant (Ke)||0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||hr-1||Full Range|Mean
1429764|NCT01012089|Primary|Volume of Distribution at Steady State (Vss)|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug|0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||L||Full Range|Mean
1429765|NCT01012089|Primary|Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-∞)||0, 0.5, 2, 3, 4.5, 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg∙hr/L||Full Range|Mean
1429766|NCT01012089|Primary|Area Under the Concentration Time Curve From Time Zero to 48 Hours (AUC0-48)||0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg∙hr/L||Full Range|Mean
1429767|NCT01012089|Primary|Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC0-24)||0, 0.5, 2, 3, 4.5, 6, and 24 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg∙hr/L||Full Range|Mean
1429768|NCT01012089|Primary|Maximum Plasma Concentration (Cmax)||0, 0.5, 2, 3, 4.5 6, 24, and 48 hours post dose|The PK analysis population were pediatric dialysis patients who had either confirmed or suspected infection who received appropriate antibiotic treatment of their infection along with a single dose of daptomycin|||mg/L||Full Range|Mean
1429769|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 6.5% who had HbA1c < 6.5% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 6.5%|||percentage of participants|||Number
1429770|NCT01012037|Secondary|The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment|Percentage of those patients with baseline HbA1c >= 7.0% who had HbA1c < 7% at Week 12. The analysis was performed on the full analysis set (FAS) using NCF.|12 weeks|FAS (NCF) with baseline HbA1c >= 7.0%|||percentage of participants|||Number
1429772|NCT01012037|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12|Percentage of patients with HbA1c lowering by at least 0.5% after 12 weeks. The analysis was performed on the full analysis set (FAS) using NCF.|Week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Patients without a value at Week 12 were analysed as non-responders|||percent|||Number
1429773|NCT01012037|Secondary|FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.|||percent||Standard Error|Mean
1429774|NCT01012037|Secondary|FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, baseline FPG, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|Patients from FAS with values for FPG at baseline and on-treatment. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.|||percent||Standard Error|Mean
1429775|NCT01012037|Secondary|FPG Change From Baseline at Week 12|Change from baseline reflects the Week 12 FPG minus the baseline FPG. Treatment means are adjusted for baseline HbA1c, baseline fasting plasma glucose and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|Patients from FAS with values for FPG at baseline and on-treatment. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Mean
1429776|NCT01012037|Secondary|HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 12 value were handled by the statistical model.|||percent||Standard Error|Mean
1429777|NCT01012037|Secondary|HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis|Mixed model includes treatment, baseline HbA1c, use of prior oral antidiabetics (OADs) in addition to background metformin, week repeated within patient, week by treatment interaction.|Baseline and week 6|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. No imputation was performed. Patients without a Week 6 value were handled by the statistical model.|||percent||Standard Error|Mean
1429778|NCT01012037|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.|Baseline and week 12|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
1429779|NCT01011946|Primary|Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer|Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as “normal” or “abnormal”. Lymph Node (LN) sampling and histopathology determined true positives and true negatives.|PEM was performed prior to surgery and LN sampling immediately following surgery||||percentage of subjects||95% Confidence Interval|Number
1429780|NCT01011933|Other Pre-specified|Patient Vital Status|Patients alive or dead after 24 months from time of study entry.|Study entry up to 2 years||||participants|||Number
1429781|NCT01011933|Other Pre-specified|Number of Participants Off Study Therapy for Each Reason Specified.||from study entry until end of study treatment, up to 5 years.||||participants|||Number
1429782|NCT01011933|Secondary|Duration of Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients|||months||Inter-Quartile Range|Median
1429783|NCT01011933|Secondary|Duration of Progression-free Survival|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for the first 6 months; then every 3 months thereafter for up to 5 years|Eligible and treated patients|||months||Inter-Quartile Range|Median
1429784|NCT01011933|Primary|Participants With Severity of Adverse Effects as Assessed by CTCAE v3.0||Each cycle during treatment and 30 days after the last treatment.|Eligible and evaluable patients|||Participants|||Count of Participants
1429785|NCT01011933|Primary|Objective Tumor Response Rate Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors (RECIST) Criteria: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at study entry, is required; Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry; Stable Disease is any condition not meeting the above criteria.|From study entry, assessed up to 5 years||||participants|||Number
1429833|NCT01011556|Secondary|Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.|Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position.|||mmHg||Standard Deviation|Mean
1429786|NCT01011933|Primary|Number of Participants With or Without Progression-free Survival for > 6 Months by Response Evaluation Criteria for Solid Tumors (RECIST)|"Number of participants who survived progression-free for more than 6 months.~Progression is defined using Response Evaluation Criteria for Solid Tumors (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions in the opinion of the treating physician, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression."|> 6 months from study entry||||participants|||Number
1429787|NCT01011907|Secondary|Alcohol Craving as Measured by the Obsessive Compulsive Drinking Scale (OCDS) Between Varenicline and Placebo Groups for Completers of the Study.|Higher scores on the OCDS indicate increased craving. OCDS possible score range = 0 - 40. Difference in average OCDS scores from week 1 to week 12 were reported for the varenicline and placebo groups in subjects that completed the study.|Week 1 to Week 12||||Scores on a scale||Standard Error|Mean
1429788|NCT01011907|Secondary|Average Number of Alcoholic Drinks Consumed Between the Varenicline and Placebo Groups for Completers of the Study Through Week 12.||Weeks 1-12||||drinks||Standard Error|Mean
1429789|NCT01011907|Primary|Average Number of Cigarettes Smoked Between the Varenicline and Placebo Groups for Completers Through Week 12.||Weeks 1-12||||cigarettes||Standard Error|Mean
1429790|NCT01011894|Primary|Best Response|The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Complete Response (CR): Absence of lymphadenopathy, hepatomegaly or splenomegaly by physical examination and appropriate radiographic techniques (if abnormal pre-treatment), No constitutional symptoms, ANC >/= 1,500/ul, platelets> 100,000/ul, Hgb>11gm/dl (untransfused); Partial Response (PR): >50% decrease in peripheral blood lymphocyte count from the pre-treatment baseline value, reduction in lymphadenopathy, reduction in size of the liver and/or the spleen; Progressive Disease (PD): Characterized by at least one of the following: > 50% increase in the sum of the products of at least 2 lymph nodes on at least 2 consecutive exams at least 2 weeks apart. At least 1 node must be >/= to 2cm in size, Appearance of new palpable LN, > 50% increase in size of liver or spleen determined by measurement below the respective costal|2 years|20 participants had Stable Disease, 3 had Progression of Disease, 3 were not evaluable due to toxicity|||Participants|||Count of Participants
1429791|NCT01011868|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment|The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% After 18, 54, and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (NCF)|||participants|||Number
1429792|NCT01011868|Other Pre-specified|Confirmed Hypoglycemic Events|Confirmed hypoglycemic events refer to all hypoglycemic events that had a glucose value ≤70 ml/dL or where assistance was required. Symptomatic hypoglycemic events were to be reported as adverse events. Investigator-defined hypoglycaemia adverse events include all events that investigator marked as ‘Hypoglycaemic event’ in CRFs, regardless of the reported term or blood glucose value. It may include hypoglycemia itself as reported term or any other symptoms that that investigator may have attributed to hypoglycemia (e.g. dizziness, hyperhidrosis, and asthenia).|During the course of the study (82 weeks)|Treated set (TS). Treatment assignment as first medication taken.|||participants|||Number
1429793|NCT01011868|Secondary|Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment|Change from baseline in HbA1c after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|Week 54 - FAS (OC-78) Week 78 - FAS78-completers (LOCF-78)|||percentage of HbA1c||Standard Error|Mean
1429794|NCT01011868|Secondary|Change From Baseline in Body Weight at Follow-up|Change from baseline in body weight at follow up (82 weeks)|Baseline and 82 weeks|FAS-FU (OR)|||kg||Standard Deviation|Mean
1429795|NCT01011868|Secondary|Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment|Change from baseline in body weight after 18, 54 and 78 weeks of treatment|Baseline, 18, 54, 78 weeks|FAS (OC)|||kg||Standard Error|Mean
1429796|NCT01011868|Secondary|Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment|Change from baseline in basal insulin dose/day after 54 and 78 weeks of treatment|Baseline, 54 and 78 weeks|FAS (OC-78) for week 54 FAS78-completers (LOCF-78) for week 78 - Values after start of antidiabetic rescue therapy except changes in basal insulin dose were set to missing and last observation carried forward (LOCF) was used for imputation of missing values|||IU||Standard Error|Mean
1429797|NCT01011868|Secondary|Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Percent change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS (OC)|||percentage of Change from BL in FPG||Standard Error|Mean
1429798|NCT01011868|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment|Change from baseline in fasting plasma glucose (FPG) after 18, 54 and 78 weeks of treatment|Baseline, 18, 54 and 78 weeks|FAS observed cases (OC)|||mg/dL||Standard Error|Mean
1429799|NCT01011868|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment|Patients that had a reduction in HbA1c of at least 0.5% from baseline to 18, 54 and 78 weeks of treatment|Baseline and 18, 54 and 78 weeks|FAS with non-completers considered failure (NCF)|||participants|||Number
1429800|NCT01011868|Primary|Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment|Baseline and 18 weeks|"FAS18-completers-included FAS patients not prematurely discontinue prior to Week 18, completed required minimum treatment duration, and had an on treatment HbA1c value within Week 18 time window. Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF-18) was used for imputation.~(LOCF-18)"|||percentage of HbA1c||Standard Error|Mean
1429801|NCT01011829|Secondary|Retention (Completion)|Retention was determined by the proportion of participants retained for the entire trial and time until drop-out.|8-weeks|Intention to treat|||participants|||Number
1429834|NCT01011556|Secondary|Change From Baseline in Urine Calcium Excretion at 6 and 12 Months||Baseline, 6 Months, 12 Months|All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint.|||millimole/day (mmol/day)||Standard Deviation|Mean
1429802|NCT01011829|Primary|Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.|Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.|8-weeks|Intention to treat|||total MA-free urine drug screens|Participants|Standard Deviation|Mean
1429803|NCT01011816|Secondary|Roland-Morris Disability Questionnaire Score|"Percent of subjects achieving a minimum 30% decrease in Roland-Morris Disability Questionnaire score~The Roland-Morris Disability Questionnaire is a widely studied and frequently used instrument for the assessment of function and disability related to low back pain. The questionnaire consists of 24 statements related to how a subject’s back condition affects various activities of daily living. Subjects marked whether the statement either applied to them or did not apply at the time they responded to the statements. The score is the total number of questions with which the subject agreed. A higher score indicates less function and greater disability."|26-weeks|All subjects assigned as success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).|||percentage of subjects|||Number
1429804|NCT01011816|Secondary|Visual Analog Scale for Low Back Pain|"Percent of subjects achieving a minimum 30% decrease in pain from baseline.~The visual analog scale is a horizontal 100 mm line anchored on the left with the words “No Pain” and on the right with the words “Worst Possible Pain”. Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the subject to indicate the subject’s level of low back pain experienced over the last week."|26-weeks|All subjects assigned success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).|||percentage of subjects|||Number
1429805|NCT01011816|Primary|Subject Composite Success|Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.|26 weeks|All subjects adjudicated as a success or failure. Missed 26-week visit counted as failure (7 BIOSTAT BIOLOGX; 2 Saline). Unblinded subjects counted as failures (2 BIOSTAT BIOLOGX).|||percentage of subjects|||Number
1429806|NCT01011738|Secondary|Number of Deaths During Observation Period|The clinical endpoint of deaths due to any cause during observation period is presented.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of peginterferon alfa-2a and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
1429807|NCT01011738|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Events (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
1429808|NCT01011738|Secondary|Number of Participants With Non-Serious Adverse Drug Reactions|Non serious adverse drug reactions (NSADRs) are all noxious and unintended responses to a medicinal product related to any dose.|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
1429809|NCT01011738|Secondary|Number of Participants With Serious Adverse Drug Reactions|"A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: Results in death, is life-threatening, NOTE: The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect."|Up to 276 Weeks|Safety population was defined to include participants with informed consent who received at least one dose of PEG IFN and had at least one post-baseline safety assessment (any assessment after baseline).|||Participants|||Number
1429810|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B Associated Clinical Endpoints- Liver Cirrhosis|Number of participants with clinical endpoints associated with CHB captured in the medical record, where data available, are reported. The clinical endpoints included development of cirrhosis (in participants without cirrhosis at baseline). The liver cirrhosis assessments were summarized from Week 12 to 3 years post-treatment.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Participants|||Number
1429811|NCT01011738|Secondary|Number of Participants With Chronic Hepatitis B - Associated Clinical Endpoints- Liver Transplantation, Hepatocellular Carcinoma, and Liver Decompensation|Number of clinical endpoints associated with CHB reported in the medical record, where data available, are reported. The clinical endpoints included liver transplantation, hepatocellular carcinoma, liver decompensation, development of cirrhosis (in patients without cirrhosis at baseline).|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Participants|||Number
1429812|NCT01011738|Secondary|Alanine Transaminase Ratio Over Time by Hepatitis B Virus e Antigen Status|ALT ratio was calculated as serum ALT, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Ratio||Standard Deviation|Mean
1429813|NCT01011738|Secondary|Percentage of Participants With Normalization of Alanine Transaminase|A participant was considered to have achieved normalization of alanine transaminase (ALT) if the ALT measurement was lower or equal to the upper limit of the normal range. Only patients with elevated ALT at baseline were included in any analyses where normalization of ALT was used as endpoint. It was analyzed as last serum ALT in the analyzed time window, divided by the upper limit of the normal range.|Up to 276 Weeks|mITT included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
1429814|NCT01011738|Secondary|Quantitative Hepatitis B Surface Antigen|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic hepatitis B participants. Last approved quantitative HBsAg measurement in the analyzed time window.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Log10 IU/mL||Standard Deviation|Mean
1429815|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion|Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection. A participant was considered to have achieved HBsAg seroconversion if (a) the participant achieved HBsAg clearance and (b) the last approved anti-HBs measurement in the analyzed time window was reported as i) ‘POSITIVE’ or (ii) quantitative result and was greater than or equal to the reported lower limit of detection.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
1429816|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Negative Participants|The probability that the participant who develops an early virological/serological response would achieve HBsAg clearance 3 years post-treatment is called the PPV of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the NPV of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg negative patients, any decline in HBsAg from baseline to Week 12 and 24 and at least a 10% decline in HBsAg from baseline to Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
1429817|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid <2000IU/mL in Hepatitis B Virus e Antigen Positive Participants|"A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL. If a patient received NUCs after end of PEG IFN treatment, then a reported suppression of HBV DNA to < 2,000 IU/mL during or after this NUC treatment were to be ignored, and HBV DNA ≥ 2,000 IU/mL was to be assigned. However, HBV DNA < 2,000 IU/mL was not to be ignored, if the NUC treatment given parallel to PEG IFN was discontinued within the first 8 weeks after end of PEG IFN treatment and prior to the HBV DNA value concerned no further NUCs were administered.~Abbreviations for Seroconversion=sercnvrsn, Analysis A= AnalysA, and Analysis B= AnalysB, pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
1429818|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Loss in Hepatitis B Virus e Antigen Positive Participants|A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) ‘NEGATIVE’ or (b) a quantitative result was lower than the reported lower detection limit. This endpoint was measured in the participants with HBeAg positive CHB.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
1429819|NCT01011738|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion in Hepatitis B Virus e Antigen Positive Participants|"HBeAg seroconversion is presented as percentage of participants who become HBeAg negative and anti-HBe positive. A participant was considered to have achieved HBeAg seroconversion if (a) the participant achieved HBeAg loss and (b) the anti-HBe measurement was reported as (i) ‘POSITIVE’ or (ii) a quantitative result considered ‘positive’ in the context. HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL: A participant was considered to have achieved HBeAg seroconversion and suppression of HBV DNA to <2,000 IU/mL if (a) the participant achieved HBeAg seroconversion and (b) the participant achieved suppression of HBV DNA to <2,000 IU/mL.~Abbreviations for pt=post-treatment."|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
1429835|NCT01011556|Secondary|Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours|Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + [(40 - albumin) x 0.02]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).|Baseline, 12 Months|All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint.|||millimole/Liter (mmol/L)||Standard Deviation|Mean
1430240|NCT01007812|Primary|Overall Vision|Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week’s wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per Protocol|||Units on a Scale||Standard Deviation|Mean
1429820|NCT01011738|Primary|Predictive Values of Early on Treatment Response for Hepatitis B Surface Antigen Clearance 3 Years Post-Treatment- Hepatitis B Virus e Antigen Positive Participants|The probability that the participant who develops an early virological/serological response would achieve Hepatitis B Surface Antigen (HBsAg) clearance 3 years post-treatment is called the positive predictive value (PPV) of the early virological/serological response. The probability that the participant who fails to develop an early virological/serological response also would fail to achieve HBsAg clearance 3 years post-treatment is called the negative predictive value (NPV) of the early virological/serological response. The positive and negative predictive values of early response at Weeks 12 and 24 on achievement of HBsAg clearance at 3 years post-treatment were examined. The following evidence of early response was explored (giving both NPV and PPV): For HBeAg positive participant, HBsAg <1,500 International Units Per Milliliter (IU/mL) and HBsAg <20,000 IU/mL at Weeks 12 and 24.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1429821|NCT01011738|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid to <2,000 International Units Per Milliliter|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol.|||Percentage of Participants||95% Confidence Interval|Number
1429822|NCT01011738|Primary|Percentage of Participants With Hepatitis B Virus Surface Antigen Clearance|Percentage of participants who became Hepatitis B Virus Surface Antigen (HBsAg) negative by the end of the observation period. A participant was considered to have achieved HBsAg clearance if the HBsAg measurement was reported as: (a) ‘Negative’ or (b) a quantitative result lower than the reported lower limit of detection. An observational period was upto 3 years post-treatment. The analysis was performed by 2 methods: Analysis A and Analysis B. For analysis A, all participants included in the analyzed population were used (participants with missing measurement for calculation of the endpoint were considered non-responders regarding the endpoint). For analysis B method, only participants in the analyzed population without missing measurements for calculation of the endpoint were used (analysis “as observed”).|Up to 276 Weeks|mITT population included all participants of the target population who could be classified regarding their HBeAg status. The target analysis population was per the inclusion/exclusion criteria mentioned in the protocol. Data of participants available at the assessment time point were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1429823|NCT01011673|Secondary|Satisfaction Scores|"24 hours after the emergency department visit, patients were asked, The next time you come to the Er with this type of headache, do you want to receive the same medication? Affirmative answers are tabulated here."|24 hours|3 patients in each group were lost to follow-up. All others are tabulated here.|||participants|||Number
1429824|NCT01011673|Primary|Change in Pain Score|At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score|Baseline, 60 minutes|3 randomized patients were not included in this analysis. During the ED visit, these patients were diagnosed with intracranial hemorrhage, brain abscess, and malaria and therefore did not truly have a primary headache disorder. Including these patients, 123 were randomized.|||units on a scale||Standard Deviation|Mean
1429825|NCT01011634|Primary|Pain Score Within 5 Mins After Procedure||within 5 mins after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.||||||
1429826|NCT01011634|Secondary|Acceptability of Pain, Would They Choose the Same Regimen Again for Another Uterine Aspiration||30 min after procedure|Study was stopped due to low enrollment (7%). No data analysis performed.||||||
1429827|NCT01011556|Secondary|DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up|Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months.|||participants|||Number
1429828|NCT01011556|Secondary|DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up|Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)|13 Month follow-up|All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months.|||participants|||Number
1429829|NCT01011556|Secondary|Pharmacokinetics Parameters: Maximal Concentration (Cmax)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, 12 Months|Due to high intra-subject variability, zero participants were analyzed for this outcome measure.||||||
1429830|NCT01011556|Secondary|Pharmacokinetics Parameters: Area Under the Curve (AUC)|Due to high intra-subject variability, data was not analyzed for this outcome measure.|Baseline, 1 Month, 3 Months, and 12 Months|Due to high intra-subject variability, zero participants were analyzed on this outcome measure.||||||
1429831|NCT01011556|Secondary|Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels|Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).|Baseline and 1, 3, 12, and 13 Months (mon)|All randomized participants who received at least one dose of study drug and had antibody results.|||participants|||Number
1429832|NCT01011556|Secondary|Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).||Pre-dose, 30 minutes, 2 hours at Baseline and 12 Months|All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position.|||beats per minute (bpm)||Standard Deviation|Mean
1430241|NCT01007656|Primary|R-glutamyl Transpeptidase (r-GT)||90 days||||U/L||Standard Deviation|Mean
1430242|NCT01007656|Primary|Glucose||90 days||||mg/dL||Standard Deviation|Mean
1430243|NCT01007656|Primary|Globulin||90 days||||g/dL||Standard Deviation|Mean
1429836|NCT01011556|Secondary|Convenience/Ease of Use Questionnaire (CEUQ)|CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.|baseline up to 12 months|All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire.|||participants|||Number
1429837|NCT01011556|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.|||percentage change in P1CP||Standard Deviation|Median
1429838|NCT01011556|Secondary|Percent Change From Baseline of C-Terminal Telopeptide (CTX)|C-terminal telopeptide is a marker of bone resorption.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.|||percentage change in CTX||Standard Deviation|Mean
1429839|NCT01011556|Secondary|Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)|Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.|Baseline, 1 Month, 3 Months, 6 Months, 12 Months|All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.|||percentage change in P1NP||Standard Deviation|Mean
1429840|NCT01011556|Secondary|Time Course Change of BMD Response at the Lumbar Spine|To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).|Baseline to 6 Months and 12 Months|All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal.|||percentage change in BMD||90% Confidence Interval|Least Squares Mean
1429841|NCT01011556|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|Baseline, 6 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model.|||percentage change in BMD||90% Confidence Interval|Least Squares Mean
1429842|NCT01011556|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months|Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.|Baseline, 12 Months|All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.|||percentage change in BMD||90% Confidence Interval|Least Squares Mean
1429843|NCT01011465|Primary|Speech Threat and Challenge|Measure of threat and challenge calculated from observation of non-verbal behavioral cues during stress exposure. Threat (negative reaction) results when an individual does not feel that he or she has sufficient resources to complete a task or manage a difficult situation. Its reverse, challenge (positive reaction), occurs when an individual perceives that he or she has sufficient resources. Independent observers used videotapes of behavior during the stress tasks and rated participants on 7 point scales for 11 challenge-related behaviors (comfortable, confident, enthusiastic, clear, alert, high level of eye contact, etc), and for 8 threat-related behaviors (agitation, rigid posture, speech disfluency, etc). Challenge scores were averaged, and threat scores averaged then reverse-scored. The mean of challenge and reversed threat scores comprise the score used here. Range: 1.1 to 6.1, with higher scores representing more challenge orientation and reflecting a better outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom speech threat score was calculated, were included|||units on a scale||Standard Deviation|Mean
1429844|NCT01011465|Primary|Difference of Pre-count and Baseline Self-reported Negative Affect (Using Negative Sub-scale of Positive and Negative Affect Schedule (PANAS) Measure).|Based on 20-item Positive and Negative Affect Schedule (PANAS) which comprises two mood scales, positive affect and negative affect. Each item is rated on a 5-point scale ranging from (1 = very slightly or not at all) to (5 = extremely) to indicate how the respondent felt at the moment the question was asked. Here, we’ve used the negative affect sub-scale which consists of the sum of the 10 negative affect items, with a possible range of 10 (least negative affect) to 50 (most negative affect). This score was measured at baseline (study range: 10 to 29) and directly before stress exposure (study range: 10 to 37), and the reported value is the difference between these two scores (range of differences: -13 to 26). It estimates negative affect due to anticipatory stress. The value is the difference between the pre-stress measure and baseline measure, therefore a larger number for the difference means a bigger increase in negative affect due to anticipatory stress, and is a worse outcome.|2 hours|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom negative affect score was calculated, were included|||units on a scale||Standard Deviation|Mean
1429859|NCT01011179|Primary|Juvenile Arthritis Quality of Life Questionnaire (JAQQ)|The questionnaire is divided into 4 dimensions: gross motor function, fine motor function, psychosocial function, and general symptoms. A 7-point ordinal scale is used to rate responses to each item from 1 (none of the time) to 7 (all of the time), based on how often the item was a problem for the child over the past 2 weeks. Total score was composed of the 4 dimension scores (top 5 items of that dimension) divided by 4, with higher scores denoting poorer HRQOL.|Baseline (prior to randomization) and 3 months after intervention||||units on a scale||Standard Deviation|Mean
1430244|NCT01007656|Primary|Creatinine||90 days||||mg/dL||Standard Deviation|Mean
1430245|NCT01007656|Primary|Cholesterol||90 days||||mg/dL||Standard Deviation|Mean
1429845|NCT01011465|Primary|Systolic Blood Pressure Change From Baseline to Second Stress Task Experience - Autonomic Stress Response Measure|Systolic blood pressure (SBP)is connected with reaction to exposure to stress. Systolic blood pressure is collected at baseline and after nasal spray administration/directly before stress tasks; it represents anticipatory stress reaction. This measure represents the difference between baseline and pre-task systolic blood pressure values. A greater difference score represents an increase from baseline in systolic blood pressure during the pre-task, and so a larger difference score represents higher reactivity. A lower difference score, or negative difference score, indicates a lower increase, or even decrease, from baseline in systolic blood pressure during the pre-task and reflects less reactivity. Reactivity is associated with increased risk of developing hypertension. Range of baseline/pre-count differences in SBP: -11 to 37.7|within 2 hours of treatment|All participants who received oxytocin or placebo, who completed the study, had relevant covariate data, and for whom systolic blood pressure was collected, were included|||mm Hg||Standard Deviation|Mean
1429846|NCT01011387|Primary|Mean Change in Wound Area.|Measured by tracing of wound and measured by planimeter.|From baseline to maximum 4 weeks||||cm2||Full Range|Mean
1429847|NCT01011335|Primary|Immunogenicity: Geometric Mean Concentrations After First Injection, Completer Population|Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human or animal. Immunogenicity was determined on the basis of anti-rAT and anti-rLukS-PV IgG concentrations assessed by enzyme-linked immunosorbent assay (ELISA) in sera from blood samples collected on Days 0 (baseline), 14, 28 and 84 for those receiving a single dose of vaccine. For those receiving a second dose of vaccine, immunogenicity assessments were also conducted on Days 98 and 112. Immunogenicity was evaluated using the following metrics: geometric mean concentrations (GMCs), geometric mean fold increase (GMFIs) and seroresponse status. Seroresponse variables are normally defined in terms of exceeding a threshold.|Up to 3 months||||μg/mL||95% Confidence Interval|Geometric Mean
1429848|NCT01011335|Primary|Assessment of Safety Through Clinical Examinations, Clinical Laboratory Results, Self-reported Diary Reactogenicity Data and Adverse Event Reports|Adverse events, local reactogenicity, and systemic reactogenicity were assessed through clinical examination by study providers, clinical lab results, as well as review of subject-completed diary|Up to 6 months||||events|||Number
1429849|NCT01011309|Secondary|IgG Antibodies and T-cell Cytokine Responses (IFN-g and IL-10)|Immunogenicity of the vaccine was evaluated by measuring IgG antibody and T-cell responses to the LEISH-F2 protein and soluble Leishmania antigen (SLA). IgG antibodies were measured by ELISA and T-cell cytokine responses (IFN-g and IL-10) were measured by Luminex. Data is presented as median Post:Pre ratios comparing Days 56/84 or 168 to baseline at Day 0.|Days 0, 56 or 84, and 168|Per-protocol population: patients who received all three study injections (immunotherapy groups) or at least 15 SSG injections (chemotherapy group) and completed the Day 84 or Day 56 visit.|||Relative ELISA Units||Full Range|Median
1429850|NCT01011309|Primary|Adverse Events of Grade 1 Severity or Higher Occurring in ≥ 3 Patients During Active Treatment Phase of the Study.|Safety of immunotherapy with the vaccine was compared to the safety of chemotherapy with sodium stibogluconate. All adverse events are listed regardless of relatedness.|Day 0 through Day 84|Safety population: All patients who received at least one study injection.|||participants|||Number
1429851|NCT01011309|Primary|Date of Clinical Cure|Efficacy of immunotherapy with the LEISH-F2 + MPL-SE vaccine was compared to the efficacy of chemotherapy with sodium stibogluconate in the treatment of CL. Efficacy is measured by the date of clinical cure.|Day 84|Per-protocol population: All patients who received all three study injections if in the immunotherapy groups or at least 15 injections of SSG if in the chemotherapy group, and completed the Day 56 visit (Immunotherapy v1.6), the Day 84 visit (Immunotherapy v1.4/1.5), or the Day 56 or Day 84 visit (Chemotherapy group).|||participants|||Number
1429852|NCT01011283|Secondary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.~Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|36 Weeks|Intent to Treat Population|||Percentage of Participants|||Number
1429853|NCT01011283|Primary|Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.|"Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.~Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10^9/L; Neutrophils ≥ 1.0 X 10^9/Lb; Blasts 0%.~Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR."|13 Weeks|Intent to Treat Population|||Percentage of Participants|||Number
1429854|NCT01011179|Secondary|Stress (Perceived Stress Questionnaire; PSQ)||Baseline (prior to randomization) and 3 months after intervention|||||||
1429855|NCT01011179|Secondary|Adherence to Treatment (Child Adherence Report Questionnaire; CARQ)||Baseline (prior to randomization) and 3 months after intervention|||||||
1429856|NCT01011179|Secondary|Self-efficacy (Children's Arthritis Self-Efficacy Scale; CASE)||Baseline (prior to randomization) and 3 months after intervention|||||||
1429857|NCT01011179|Secondary|Pain Coping (Pain Coping Questionnaire)||Baseline (prior to randomization) and 3 months after intervention|||||||
1429858|NCT01011179|Secondary|Disease Specific Knowledge (Medical Issues, Exercise, Pain and Social Support Questionnaire; MEPS)||Baseline (prior to randomization) and 3 months after intervention|||||||
1429930|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index|Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
1430246|NCT01007656|Primary|BUN||90 days||||mg/dL||Standard Deviation|Mean
1429860|NCT01011153|Secondary|To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians.|For each case reviewed, physicians were asked if they thought the lesion was a melanoma (diagnostic sensitivity/specificity) and whether or not they would biopsy or refer the lesion (biopsy/referral sensitivity/specificity. These measurements were compared using areas under the corresponding receiver operating characteristic curves. (see statistical analysis for results) ROC curves (reciver operating curves) are plotted on graphs with an x-axis of sensitivity and a y-axis of 1-specificity.|June 2010||||Area Under Curve for biopsy/referral||Standard Deviation|Geometric Mean
1429861|NCT01011153|Secondary|Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.|Each physician was given up to 130 cases and asked whether or not they would biopsy the lesion. Interobserver variability was measured via the kappa statistic indicating how well the physicians' answers to that question agreed within each group. Kappa statistics are reported in the statistical analysis. while numbers rep, they dont reflect the sgreement among the subjects|December 2009|The statistical analysis section contains the Kappa results within Each of the Caregiver Groups|||Number of Cases|||Number
1429862|NCT01011153|Secondary|Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of each group of physicians to that of Melafind, which is presented in the statistical analysis.|December 2009|Each category was diminished after excluded subjects were taken into account. These included subjects who did not complete at least 78 cases, subjects who previously participated in other EOS studies, pediatricians, and a board eligible dermatologist.|||Proportion of True Cases||95% Confidence Interval|Mean
1429863|NCT01011153|Primary|Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)|Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.|April 2010|Participants were invited to enroll in this study via mail. Minimum number of participants was determined by statistician based on power analyses and number of cases completed. The time frame of the study was about 6 months and the comparison between Dermatologists and MelaFind is presented in the statistical analysis section below.|||Proportion of True Cases||95% Confidence Interval|Mean
1429864|NCT01011075|Secondary|Toxicities|Adverse events of grade 3 or higher, according to CTCAE version 3|12 months|All enrolled and treated patients were evaluated for grade 3 or higher toxicities.|||Number of events|||Number
1429865|NCT01011075|Secondary|Progression Free Survival|Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)|12 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.|||Months||95% Confidence Interval|Median
1429866|NCT01011075|Secondary|Overall Survival|Overall survival as measured by the Kaplan-Meier method|12 Months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.|||Months||95% Confidence Interval|Median
1429867|NCT01011075|Primary|Response Rate|Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.|6 months|6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.|||Percentage of Participants||95% Confidence Interval|Number
1429868|NCT01011049|Secondary|Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post-vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per protocol population.|||Percentage of Participants|||Number
1429869|NCT01011049|Secondary|Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.|Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.|Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
1429870|NCT01011049|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1429871|NCT01011049|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).|Day 0 through Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Participants|||Number
1429931|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Problems With Self-Concept|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
1429872|NCT01010984|Secondary|Progression Free Survival|Progression is determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Progressive disease is defined as at least 20% increase in the sum of the longest target lesions, taking as reference the smallest sum longest diameter recorded since start of treatment OR appearance of one or more new lesions greater then 1cm in size. Percentage of tumor response will be assessed up to 1 year post treatment.|Percentage of tumor response assessed up to 1 year post treatment.|Those who receive at least one dose of LC bead with doxorubin.|||percentage of tumor response||95% Confidence Interval|Median
1429873|NCT01010984|Primary|Incidence of Adverse Events|Adverse events were collected from all 20 subjects.|Date of surgery through 2 years post procedure or until patient death|Participants who received at least one dose of LC beads with doxorubin.|||Events|||Number
1429874|NCT01010971|Secondary|Time to Maximal Effect Over the 2-week of Double-blind Treatment Period.|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo.|Week 0-2||||Days||Standard Error|Least Squares Mean
1429875|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Domains at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In Impaired Subjects with Baseline RQLQ(S) Score of ≥3.0|||units on a scale||Standard Error|Least Squares Mean
1429876|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429877|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0|||participants||Standard Error|Least Squares Mean
1429878|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective OSS in Subjects With Baseline TOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective OSS measures these symptoms over the previous 12-hour time interval. rTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS ≥5.0|||participants||Standard Error|Least Squares Mean
1429879|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429880|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429881|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous OSS in Subjects With Baseline TOSS≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous OSS measures these symptoms over the previous 10 minute time interval. iTOSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline TOSS≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429932|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
1429882|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429883|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429884|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Reflective Nasal Symptom Scores (NSS) Averaged Over the 2-week Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429885|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429886|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429887|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 2-week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429888|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429889|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429890|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429933|NCT01010750|Secondary|CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
1429891|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429892|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In subjects with baseline TOSS ≥5.0|||units on a scale||Standard Error|Least Squares Mean
1429893|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429894|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429895|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 2 Week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429896|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429897|NCT01010971|Secondary|Change From Baseline in the RQLQ(S) Overall Score at the End of the 2-week Treatment Period in Impaired Subjects With Baseline RQLQ(S) Score of ≥3.0|RQLQ(S) in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429898|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Reflective TOSS Averaged Over the 2-week Treatment Period in Subjects With Baseline TOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429899|NCT01010971|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 2-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1429900|NCT01010971|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to Treat Population. Not all subjects analyzed due to missing data.|||Units on a scale||Standard Error|Least Squares Mean
1429901|NCT01010932|Primary|Specificity|Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2 - 42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.|||percentage of non-stenotic segments|Participants|95% Confidence Interval|Number
1429902|NCT01010932|Primary|Sensitivity|Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060).|2-42 days|For 3 patients, MRA images were not analyzed: 2 patients with incomplete images and 1 patient who did not undergo CTA procedure.|||percentage of stenotic segments|Participants|95% Confidence Interval|Number
1429903|NCT01010932|Primary|Technical Failure Rate|Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060).|2 - 28 days|For 2 patients, MRA images were not analyzed because images were incomplete.|||percentage of arterial segments|Participants|95% Confidence Interval|Number
1429904|NCT01010906|Secondary|Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug.|||µM||95% Confidence Interval|Geometric Mean
1429905|NCT01010906|Primary|Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration|Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.|0-48 hours postdose|Participants administered at least one dose of investigational drug. AUC for one participant with Mild HI was not estimated due to poor correlation of the linear regression.|||µM.hr||95% Confidence Interval|Geometric Mean
1429906|NCT01010867|Secondary|Number of Acute Graft Versus Host Disease (GVHD) Events in HSCT Patients Who Have Been Administered Lactobacillus Plantarum||Up to Day +100 of HSCT||||Number of GVHD events|||Number
1429907|NCT01010867|Secondary|Number of Non-lactobacillus Infections|To determine incidence of bacteremia in HSCT patients who have been administered lactobacillus plantarum.|36 days (day -7 to +28 of HSCT)||||Number of non-lactobacillus infections|||Number
1429908|NCT01010867|Secondary|Adherence With the Prescribed Dose, Measured as the Percentage of Prescribed Probiotic Doses|To determine the feasibility of administration of L. plantarum 299 and 299v. The treatment is considered feasible for a patient if he/she received at least 50% of the probiotic dose (>= 11 days of treatment).|22 days (day -7 to +14 of HSCT)||||percentage of prescribed doses||Full Range|Median
1429909|NCT01010867|Primary|Number of Lactobacillus Plantarum Bacteremia Infections||36 days (day -7 to +28 of HSCT)|Children and adolescents undergoing hematopoietic stem cell transplantation (HSCT)|||Number of infections||95% Confidence Interval|Number
1429910|NCT01010854|Secondary|Clinical Response Based on Tumor Measurement||after 4 cycles of therapy||||Participants|||Count of Participants
1429911|NCT01010854|Primary|Pathologic Response at Definitive Surgery||after 4 cycles of therapy||||Participants|||Count of Participants
1429912|NCT01010776|Other Pre-specified|Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13, 26, 39 and 52|The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1429913|NCT01010776|Other Pre-specified|Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline, Week 4, 8, 13 and 26|The safety analysis population included all the participants that received at least one dose of study medication and provided any post-baseline information. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1430247|NCT01007656|Primary|Total Bilirubin|Bilirubin is released into the blood when red blood cells break down. The liver uses bilirubin to make bile. Normally there is only a small amount of bilirubin in the blood. High levels may be caused by liver or blood problems.|90 days||||mg/dL||Standard Deviation|Mean
1429914|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1429915|NCT01010776|Secondary|36-Item Short-Form Health Survey (SF-36) Score - Main Phase|The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.|Baseline and Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1429916|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase|Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of participants|||Number
1429917|NCT01010776|Secondary|Percentage of Participants With Treatment Satisfaction - Main Phase|Participant’s response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of Participants|||Number
1429918|NCT01010776|Secondary|Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Extension Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Week 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Participants|||Number
1429919|NCT01010776|Secondary|Number of Participants With Clinical Global Impression–Severity (CGI-S) Score - Main Phase|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Participants|||Number
1429920|NCT01010776|Secondary|Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1429921|NCT01010776|Secondary|Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase|The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1432195|NCT00994682|Secondary|Bone Mineral Density|Bone mineral density measured at the levels of spine, femoral neck, hip, and wrist by DXA.|18 and 36 months|Data analysis included 78 patients at month 18 and 62 at month 36 (based on DXA availability).|||g/cm^2||Standard Deviation|Mean
1429922|NCT01010776|Secondary|Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1429923|NCT01010776|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase|The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘N’ specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1429924|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase|The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13, 26, 39 and 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1429925|NCT01010776|Secondary|Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase|The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 4, 8, 13 and 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1429926|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.|||Percentage of participants||95% Confidence Interval|Number
1429927|NCT01010776|Secondary|Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase|Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 26|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.|||Percentage of participants||95% Confidence Interval|Number
1429928|NCT01010776|Primary|Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.|||Units on a scale||Standard Deviation|Mean
1429929|NCT01010776|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 26|The intent-to-treat for effectiveness (ITTe) population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Last Observation Carried Forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
1429934|NCT01010750|Secondary|Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems|Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.|2 and 14 hours post-dose on Day 7|PD|||Units on a scale||Standard Error|Mean
1429935|NCT01010750|Primary|Power of Attention Score|The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.|pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7|The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||milliseconds||Standard Error|Mean
1429936|NCT01010633|Primary|Grade 0 Pain|Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.|Visit 5 (Postoperative Day 8)|Intent to treat population (ITT)|||Eyes|Participants||Number
1429937|NCT01010633|Secondary|Resolution of Anterior Chamber Cells.|Study eyes with complete resolution of anterior chamber cells (ACC)|At visits 4-7- postoperative day 3, 8,15 & 18||||Eyes|||Number
1429938|NCT01010633|Primary|Resolution of Anterior Chamber Cells (ACC).|Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.|Visit 5 (Postoperative day 8)|Intent to treat (ITT) population|||Eyes|Participants||Number
1429939|NCT01010568|Secondary|Median PFS|Kaplan Meyer PFS|2 years||||months||95% Confidence Interval|Median
1429940|NCT01010568|Secondary|Complete Response Rate|NCI IWG response criteria|6 months||||participants|||Number
1429941|NCT01010568|Primary|Overall Response Rate|40% per the National Cancer Institute Working Group Response Criteria for Chronic Lymphocytic Leukemia|6 months||||participants|||Number
1429942|NCT01010555|Primary|On-eye Wettability|On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.|||units on a scale||Standard Deviation|Mean
1429943|NCT01010503|Secondary|Short Form-36 (SF-36)|The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.|Weeks 0, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1429944|NCT01010503|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||scores on a scale||Standard Deviation|Mean
1429945|NCT01010503|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase protein. Levels of CRP increase with inflammation.|Weeks 0, 4, 12, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
1429946|NCT01010503|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.|Weeks 0, 4, 12, 20, and 24|TT population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1429947|NCT01010503|Secondary|Tender Joint Count (TJC)|The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
1429948|NCT01010503|Secondary|Swollen Joint Count (SJC)|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
1429949|NCT01010503|Secondary|Physician's Global Assessment of Disease Activity|Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1430530|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.|||hours||Full Range|Median
1429950|NCT01010503|Secondary|Patient Global Assessment of Disease Activity|The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1429951|NCT01010503|Secondary|Patient Global Assessment of Pain|Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1429952|NCT01010503|Primary|Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg||Weeks 0, 4, 8, 12, 16, and 20|ITT Population|||percentage of participants|||Number
1429953|NCT01010503|Primary|Percentage of Participants Withdrawing From the Study Prematurely for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
1429954|NCT01010503|Primary|Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
1429955|NCT01010503|Primary|Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason||Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
1429956|NCT01010503|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Weeks 0, 4, 12, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1429957|NCT01010503|Primary|Percentage of Participants Adherent to Original Treatment|Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.|Week 24|Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug|||percentage of participants|||Number
1429958|NCT01010477|Primary|The Number of Subjects Who Quit Smoking From Weeks 5 to 8|Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.|4 weeks||||participants|||Number
1429959|NCT01010399|Secondary|Proportion of Subjects With HIV-1 RNA <50 Copies/mL||24 weeks||||participants|||Number
1429960|NCT01010399|Primary|Proportion of Subjects With Triglycerides <200 mg/dL||24 weeks||||participants|||Number
1429961|NCT01010282|Secondary|Change From Baseline in Conjunctival Staining Severity Score at Day 90|Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
1429962|NCT01010282|Secondary|Change From Baseline in Corneal Staining at Day 90|Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
1429963|NCT01010282|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Day 90|Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Seconds||Standard Deviation|Mean
1429964|NCT01010282|Secondary|Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90|Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
1429965|NCT01010282|Primary|Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90|Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.|Baseline (Day 1), Day 90|Intent-to-treat, which includes all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
1432196|NCT00994682|Secondary|Molecular Pathways of Liver Glucose and Lipid Signaling; Inflammatory Pathways; Oxidative Stress; Other.||At 18 (2nd liver biopsy) and 36 (3rd liver biopsy) months.|||||||
1429966|NCT01010230|Secondary|Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups|"Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index.~Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||ratio of RANKL/OPG||Standard Deviation|Mean
1429967|NCT01010230|Secondary|Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of 10 nmol BCE/L||Standard Deviation|Mean
1429968|NCT01010230|Secondary|Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of µg/l||Standard Deviation|Mean
1429969|NCT01010230|Secondary|Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of µg/L||Standard Deviation|Mean
1429970|NCT01010230|Secondary|Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of ng/mL||Standard Deviation|Mean
1429971|NCT01010230|Primary|Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in mg/cm^4||Standard Deviation|Mean
1429972|NCT01010230|Primary|Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups|"Since this is considered a pilot study we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification."|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in mg/cc||Standard Deviation|Mean
1429973|NCT01010230|Primary|Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in mg/cc||Standard Deviation|Mean
1429974|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in g/cm^2||Standard Deviation|Mean
1429975|NCT01010230|Primary|Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||% change in g/cm^2||Standard Deviation|Mean
1429976|NCT01010230|Primary|Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after start of intervention/|This was an intent to treat analysis.|||% change in grams/cm||Standard Deviation|Mean
1429977|NCT01010230|Secondary|Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups|Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.|Baseline and 12 months after the intervention begins|This was an intent to treat analysis.|||log of µg/L||Standard Deviation|Mean
1429978|NCT01010230|Primary|Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups|Since this is considered a “pilot study” we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.|Baseline and 12 months after start of intervention|This was an intent to treat analysis.|||% change in grams/cm||Standard Deviation|Mean
1429979|NCT01010204|Secondary|Participants Experiencing Neuropsychiatric Events|Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder.|24 weeks|Bipolar Patients|||Participants|||Count of Participants
1429980|NCT01010204|Primary|7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence|24 weeks|bipolar patients|||participants|||Number
1429981|NCT01010204|Primary|7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks|To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks|12 weeks|bipolar subjects|||participants|||Number
1429998|NCT01010009|Primary|Modulation of Levels of Total Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.|||µmol/L||Standard Error|Mean
1429982|NCT01010061|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.|||unit on a scale||Standard Deviation|Mean
1429983|NCT01010061|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score|The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.|||unit on a scale||Standard Deviation|Mean
1429984|NCT01010061|Secondary|Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)|Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).|Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)|PK population includes all participants with PK data available at the given time-point.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1429985|NCT01010061|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.|||Months||95% Confidence Interval|Median
1429986|NCT01010061|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
1429987|NCT01010061|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.|||Months||95% Confidence Interval|Median
1429988|NCT01010061|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.|||Months||95% Confidence Interval|Median
1429989|NCT01010061|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.|||Months||95% Confidence Interval|Median
1429999|NCT01009983|Secondary|Expression of EGFR and Other Protein Markers||baseline|Test not completed as specified in protocol that will only be completed if a full sample was accrued.||||||
1430000|NCT01009983|Secondary|Survival||Approximately 7 months||||months||95% Confidence Interval|Median
1430001|NCT01009983|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Approximately 7 months||||months||95% Confidence Interval|Median
1430002|NCT01009983|Primary|Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria|Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.|every 28 days for a minimum of 84 days||||participants|||Number
1429990|NCT01010061|Secondary|Percentage of Participants With Best Overall Response|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
1429991|NCT01010061|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 42 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
1429992|NCT01010061|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff (median observation 14.2 months)|Intent-to-treat population included all randomized participants. Participants without PFS events were censored.|||Percentage of participants|||Number
1429993|NCT01010061|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 14.2 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.|||Months||95% Confidence Interval|Median
1429994|NCT01010061|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.|Randomization to clinical cutoff (median observation 42 months)|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
1429995|NCT01010061|Primary|Progression-free Survival (PFS)|"PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator.~Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L)."|Randomization to clinical cutoff (median observation 42 months from randomization)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.|||Months||95% Confidence Interval|Median
1429996|NCT01010009|Primary|Modulation of Deoxygenated Levels of Haemoglobin|This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).|0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)|NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.|||µmol/L||Standard Error|Mean
1429997|NCT01010009|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|This outcome measure assessed any significant modulation of cognitive task performance during the 46-81 min post dose period. The cognitive tasks utilized were cognitively demanding computer based, numerical tasks which assessed working memory. Significant modulation is defined as significant difference between baseline and post-dose task performance.|46-81 mins post dose|Cognitive performance data was analysed for all subjects who completed the trial. If data was not utilized in the final analysis then this was either due to technical issues (i.e. the computer did not save data) or it was clear that the participant had not engaged with the task/s.|||Participants|||Number
1430003|NCT01009931|Secondary|Effects of Treatment on Immunophenotype, Signaling Profile, and Nuclear NF-kB Expression|Cycle 1 of treatment|48 months|The study participant died before the study data collection completed.||||||
1430004|NCT01009931|Primary|Grade 3 and 4 Non-hematologic Treatment-related Toxicity Rates < 25%||43 months|The study participant died before the study data collection completed.||||||
1430006|NCT01009840|Secondary|Percentage of Participants With Hepatic Veno-Occlusive Disease Based on Baltimore Criteria|The Baltimore criteria for veno-occlusive disease was defined as the development of hyperbilirubinemia with serum bilirubin > 2 mg/dl within 21 days after transplantation and at least 2 of the following clinical signs and symptoms: (1) hepatomegaly, usually painful, (2) > 5% weight gain, or (3) ascites.|6 Months|Safety population included all participants who received IV busulfan.|||Percentage of participants|||Number
1430007|NCT01009840|Secondary|Percentage of Participants With Transplant-Related Mortality|The percentage of participants with death related to transplant.|6 Months|Safety population included all participants who received IV busulfan.|||Percentage of participants|||Number
1430008|NCT01009840|Secondary|Percent Difference Between Area Under Curve (AUC) and Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. GC-MS was used to determine the busulfan level in plasma. The percent difference was calculated between AUC and the Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percent difference||Full Range|Median
1430009|NCT01009840|Secondary|Ratio Area Under Curve (AUC)/Target AUC|A test dose of IV busulfan 0.8 mg/kg was infused at Baseline (Day −12 to −9) to verify a target busulfan integrated AUC of 20,000 μM*min with a range of 16,000 to 24,000. If necessary the dose could be adjusted. The PK-directed dose recommendation based on the test dose was administered at Day -5. Blood samples for PK analysis were collected at 0, 15, 30 minutes after the End of Infusion and 240, 300, 360 minutes after start of the infusion. Gas chromatography with mass selective detection (GC-MS) was used to determine the busulfan level in plasma. The ratio was calculated: AUC/Target AUC.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Ratio||Full Range|Median
1430010|NCT01009840|Secondary|Percent Change in IV Busulfan Dose|The percent change in dose is relative to the busulfan dose administered at the Baseline Visit (Day -12 to -9) when a dose of 0.8 mg/kg was administered and on Day −5 when the Seattle Cancer Care Alliance recommended PK-adjusted dose was administered.|Baseline (Day -12 to -9), Day -5|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percent change||Full Range|Median
1430011|NCT01009840|Secondary|Percentage of Participants With Progression-free Survival Events|Progression-free survival events are death or first recurrence of progressive disease by International Myeloma Working Group Criteria.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percentage of participants|||Number
1430012|NCT01009840|Secondary|Progression-free Survival|Progression-free Survival (PFS) defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease (PD) by IMWG criteria. PD was defined as an Increase of ≥25% from the lowest response value in any one or more of the following: 1)Serum M-component and/or (the absolute increase must be ≥0.5 g/dL), 2)Urine M-component and/or (the absolute increase must be ≥200 mg/24 hr), 3)In patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL, 4)Bone marrow plasma cell percentage; the absolute percentage must be ≥10%, 5)Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas and/or 6)Development of hypercalcaemia that can be attributed solely to the plasma cell proliferative diso|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Days||95% Confidence Interval|Median
1430013|NCT01009840|Secondary|Percentage of Participants With Overall Survival Events|Overall Survival Event was death.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percentage of participants|||Number
1430014|NCT01009840|Secondary|Overall Survival|Overall Survival was defined as the time in days from transplantation to death due to all causes.|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Days||95% Confidence Interval|Median
1430015|NCT01009840|Primary|Percentage of Participants With Overall Disease Response at Month 6|The percentage of participants reported in each disease category by International Myeloma Working Group (IMWG) uniform response criteria for Multiple Myeloma 6 months after autologous Hematopoietic stem cell transplant. Overall Disease Response categories were: [stringent Complete Response (sCR)=CR + normal Free Light Chain (FLC) ratio + absence of clonal cells in bone marrow], [Complete Response (CR)=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow], [Very Good Partial Response (VGPR)=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein + urine M-protein level <100 mg/24 hour], [Partial Response (PR)=≥50% reduction of serum M-protein and reduction in 24 hour urine M-protein by ≥90% or to <200 mg per 24 hour], [Stable Disease (SD)=Not meeting criteria for CR, VGPR, PR or progressive disease] or [Progressive Disease (PD)].|6 Months|Intent-to-treat population included all participants who received the PK-directed IV busulfan followed by autologous HSCT.|||Percentage of participants|||Number
1430016|NCT01009762|Secondary|Numbers of Participants With Lowering of HIV RNA Viral-load|"HIV-1 RNA Viral load was measured by Quantitative-PCR in plasma as numbers of virus RNA copies/mm^3 relative to baseline viral-load for each participant. The numbers of participant with lowering of HIV RNA plasma Viral-load is counted at base-line and at 6 months (end of study) and provided in the table (analysis population description) and the number of participants that showed lowering of viral-load was counted.~Criteria for this anticipated end-point was a significant lowering of HIV RNA viral-load in >50% of responders (defined as participants with new T-cell responses)."|up to 6 months after treatment stop|the numbers of participants that showed changes (lowering of) in Viral load (measured as HIV-1 RNA copies/mm^3 plasma in commercial quantitative PCR) at end of study (6 months after vaccination) relative to base-line viral-load was counted at 6 month after vaccination (end of study)|||participants|||Number
1432197|NCT00994682|Secondary|Osteoporotic Fractures|Number of patients with osteoporotic fractures|18 and 36 months||||Participants|||Count of Participants
1430017|NCT01009762|Secondary|Number of Participants With New T Cell Response to the Vaccine Target Epitopes|"Number of Participants with New T Cell Response to the Vaccine Target Epitopes as Measured by Intracellular Cytokine Stain Flowcytometry (IC-FACS) and/or IFNg-ELISPOT Analysis.~Criteria's for meeting anticipated secondary end-point was that >50% of vaccinees reacted with new Clusters of differentiation 8 (CD8) T-cell and/or Clusters of differentiation 4 (CD4) T-cell response to al least one of the vaccine target epitopes as measured by IC-Facs and/or interferon-gamma (IFNg) - Enzyme-Linked ImmunoSpot (ELISPOT) assays."|10-14 days or 3 months or 6 months after last immunisation|Peripheral Blood Mononuclear Cells (PBMC) from blood was measured in IFNg-ELISPOT and/or Intracellular Cytokines (ICS) Flowcytometry for T cell responses. All 10 vaccinee developed a new T cell immune response to at least one vaccine epitope. The saline placebo did not develop any new t cell responses.|||participants|||Number
1430018|NCT01009762|Primary|Numbers of Treatment Related Side Effects (DLT = Reaction 3 or More)|the numbers of treatment related side effects (DLT = reaction 3 or more) are registered for participants|up to 6 months after end of treatment|Interview, questionaire, objective examination by medical doctor, blood testing for hematology, clinical chemistry, CD4 counts, HIV-1 viral load|||side effects|||Number
1430019|NCT01009645|Secondary|Recall Accuracy|"Participants were given 8 statements about the flu/flu shot and asked to recall if they had seen the statement on the message they received via FedEx. Participants responded that statement had been presented as a fact, presented as a myth, presented, but I don't recall if it was a fact or a myth, or not presented. Participants scored 1 for each correct answer; 0 for each incorrect answer or for response I don't recall. Recall accuracy was calculated among each message format, range for recall accuracy was 0 - 8 with 0 indicating no correct answers and 8 representing 100% accuracy. Thus units of measurement are units on a scale to represent participant scores out of 8 on the recall items."|1 week following receipt of message||||units on a scale||Standard Deviation|Mean
1430020|NCT01009645|Primary|Influenza Vaccination|The primary outcome is receipt of influenza vaccination at appointment directly following the post-test. A pre-test was completed by participants during a telephone interview that occurred approximately two weeks prior to a scheduled clinic appointment. The post-test was completed via an in-person interview by participants immediately prior to their scheduled appointment. That is, the participants met with the Research Assistant, completed the post-test, and then proceeded to see their physician for a previously scheduled office visit.|1 week following randomization||||participants|||Number
1430021|NCT01009619|Secondary|Plasma C-reactive Protein (CRP) Levels|Plasma C-reactive protein (CRP) levels were assessed using Tina-quant CRP latex assay, Roche, Mannheim, Germany; sensitivity threshold of 1 mg/L, upper limit of normal 5 mg/L.|during the first two years post-transplant||||mg/L||Standard Deviation|Mean
1430022|NCT01009619|Secondary|Broncho-alveolar (BAL) Neutrophilia|BAL was performed with two 50 mL aliquots of sterile saline at room temperature. Five mL of the recovered BAL fluid was sent for microbiological and virological assessment, whereas the remaining fluid was analysed for cell counts after a cytospin was made in a Shandon cytocentrifuge and stained with May-Grünwald-Giemsa. Differential cell counts were determined by counting at least 300 cells.|during first two years post-transplant||||percent cells||Standard Deviation|Mean
1430023|NCT01009619|Secondary|Pulmonary Function|Spirometry (Masterscreen, Jaeger, Hoechberg, Germany) was performed at twice weekly intervals for the first 2 postoperative months, thereafter at weekly to biweekly intervals until 6 months post-transplantation, then every 2 to 4 weeks until the first postoperative year and afterwards life-long at intervals of 2 to 3 months according to American Thoracic Society standards and forced expiratory volume in one second (FEV1) expressed in terms of the percentage of predicted values.|during first two years post-transplant||||percent predicted||Standard Deviation|Mean
1430024|NCT01009619|Secondary|Infection Incidence Rate|Cytomegalovirus (CMV)-status was assessed on on every broncho-alevolar lavage sample and by serum CMV DNA at weekly intervals during hospitalization and thereafter at each outpatient evaluation or hospital admission. Immunohistochemical staining for CMV was performed on transbronchial biopsies in case of clinical suspicion of infection (i.e. dyspnea, cough, sputum, fever, increased plasma C-reactive protein, new chest radiograph infiltrates, or a decrease of at least 10% in peak expiratory flow (PEF) as measured by patient’s peak flow measurements.|2 years post-transplant|intention to treat|||incidence rate (events/person per year)||Standard Deviation|Mean
1430025|NCT01009619|Secondary|Acute Rejection Incidence Rate|Bronchoscopy and broncho-alveolar lavage (BAL) was routinely performed at discharge, 3, 6, 12, 18, 24 months post-transplantation and later at intervals of 1 year, or in case of clinically suspected acute allograft rejection, infection or chronic rejection. Transbronchial biopsies were routinely performed at discharge and 3 months post-transplant or in case of suspected acute rejection, infection or chronic rejection. Biopsies were graded according to the 1996 ISHLT-guidelines (grade A0-4 with concomitant B0-4), as well as assessed for other interstitial lesions of the pulmonary graft.|2 years post-transplant||||incidence rate (events/person per year)||Standard Deviation|Mean
1430026|NCT01009619|Primary|Overall Survival|Survival data were obtained using all-cause mortality information in the Leuven University Hospital transplant database, in which all our lung transplant recipients since 1991 are registered. For the end-point of all-cause mortality, survival times were not censored at retransplantation or at study-discontinuation if these preceded death, or else at 2 years after transplantation.|2 years post-transplant|intention to treat|||participants|||Number
1430027|NCT01009619|Primary|Prevalence of Bronchiolitis Obliterans Syndrome (BOS)|BOS was defined as a sustained decrease in forced Expiratory Volume in one second (FEV1) of at least 20% from the patient's maximum post-operative values in the absence of other causes.|2 years post-transplant|intention to treat analysis|||participants|||Number
1430028|NCT01009580|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1430029|NCT01009580|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1430030|NCT01009580|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS. For 24 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1430031|NCT01009580|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was randomised in error, hence removed from the FAS.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1430032|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430033|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430034|NCT01009554|Secondary|Mean Stain Area for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430035|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 8 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430036|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 6 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430125|NCT01009099|Primary|Exercise Duration (Time Walked on the Constant Workrate Treadmill Test)|The primary outcome measure is a comparison of time walked on the constant workrate treadmill best at 12 weeks.|baseline and 12 weeks|Patients who completed 12 weeks of exercise training were analyzed. There was one patient in each group that did not complete the treadmill test at 12 weeks although they completed other secondary outcome measures. Although they did not complete this measure, they remained in the study and were not counted as a drop.|||minutes||Standard Deviation|Mean
1430037|NCT01009554|Secondary|Mean Stain Intensity for Lingual Sites at 4 Weeks|The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430038|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430039|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430040|NCT01009554|Secondary|Mean Stain Score for Lingual Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430041|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430042|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430133|NCT01009060|Secondary|Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern|Samples for urinalysis were collected on Days 1, 7, 14, 21, 28, 35, 42, 49 and up to Day 59 (follow-up) to assess specific gravity, pH, glucose, protein, blood and ketone by dipstick and microscopic examination (if blood or protein is abnormal).|Up to Day 59|Safety Population.|||Participants|||Count of Participants
1432943|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Pain/Discomfort|Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.|Week 24|Available data from participants who reached week 24 are summarized.|||Participants|||Count of Participants
1430043|NCT01009554|Secondary|Mean Stain Area for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430044|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 8 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430045|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 6 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430046|NCT01009554|Secondary|Mean Stain Intensity for Facial Sites at 4 Weeks|The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430047|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430048|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430063|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430049|NCT01009554|Secondary|Mean Stain Score for Facial Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430050|NCT01009554|Secondary|Mean Stain Area for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430051|NCT01009554|Secondary|Mean Stain Area for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430052|NCT01009554|Secondary|Mean Stain Area for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for area according to the following criteria. Stain area for the body of the tooth was scored as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430053|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430054|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430055|NCT01009554|Secondary|Mean Stain Intensity for Body Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The body regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The body regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430159|NCT01008995|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline (Week 0) to Week 12|Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group.|||Score||Standard Deviation|Mean
1430160|NCT01008995|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|All participants were included and analyzed according to their randomized treatment group.|||Participants|||Number
1430056|NCT01009554|Secondary|Mean Stain Score for Body Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430057|NCT01009554|Secondary|Mean Stain Score for Body Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430058|NCT01009554|Secondary|Mean Stain Score for Body Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for the body of the tooth was scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430059|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430060|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430061|NCT01009554|Secondary|Mean Stain Area for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for area according to the following criteria. Stain area for gingival regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430062|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430091|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430064|NCT01009554|Secondary|Mean Stain Intensity for Gingival Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The gingival regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The gingival regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430065|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430066|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430067|NCT01009554|Secondary|Mean Stain Score for Gingival Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for gingival regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430068|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430069|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430070|NCT01009554|Secondary|Mean Stain Area for Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for area according to the following criteria. Stain area for mesial and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430559|NCT01005316|Secondary|Percentage of Participants -Overall Participant and Graft Survival|This measure looks at the participants who did not die and/or did not receive a subsequent heart transplant.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
1430071|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430072|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430073|NCT01009554|Secondary|Mean Stain Intensity For Interproximal (Mesial and Distal) Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). The interproximal (mesial and distal) regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. The regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430074|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430075|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430076|NCT01009554|Secondary|Mean Stain Score for Interproximal (Mesial and Distal) Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). Stain area for mesial and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430077|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430078|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430079|NCT01009554|Secondary|Mean Stain Area Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area according to the following criteria. Stain area for mesial, gingival, and distal regions were scored as 0=no stain present, natural tooth color; 1=thin line of stain, may be discontinuous; 2=thick line or band of stain; 3=stain covers entire area and for the body of tooth as 0=no stain present, natural tooth color, 1=stain limited to pits and grooves; 2=stain outside pits/grooves, up to 10% of surface affected; 3=stain outside pits/grooves, over 10% of surface affected.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430080|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 8 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430081|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 6 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430082|NCT01009554|Secondary|Mean Stain Intensity Over All Tooth Sites at 4 Weeks|The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for intensity according to the following criteria. The intensity of yellow-brown stains occurring in each region is unrelated to the area covered with stained pellicle. All four regions were assessed on a 4-point ordinal scale as 0=no stain, 1=faint stain (can be seen with close examination), 2=moderate stain (clearly visible and aesthetically unacceptable), 3=heavy, dark stain (obvious and aesthetically unacceptable).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430083|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 8 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430092|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430084|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 6 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430085|NCT01009554|Secondary|Mean Stain Score Over All Tooth Sites at 4 Weeks|The mean stain score (0-9) per participant was determined by multiplying the individual area and intensity scores from each region and summing them then dividing by the number of sites scored. The facial and lingual surfaces of the maxillary and mandibular anterior teeth (teeth #6-11 and #22-27) were scored using the Macpherson Modification of the Lobene Stain Index. Each surface was divided into 4 regions (gingival, mesial, distal, and body). All four regions were scored for area and intensity according to the following criteria. Stain area for mesial, gingival, and distal regions were scored on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain covers entire area) and for the body of tooth on a 4-point ordinal scale (0=no stain present, natural tooth color; 3=stain outside pits/grooves, over 10% of surface affected). The intensity of yellow-brown stains occurring in each region was assessed on a 4-point ordinal scale (0=no stain; 3=heavy, dark stain).|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430086|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430087|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430088|NCT01009554|Secondary|Change in Tooth Color as Represented by Δb at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual b* color parameter was calculated. The Δb was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430089|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430090|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔL at 6 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The change in the individual L* color parameter was calculated. The ΔL was calculated per tooth and then averaged over the teeth for a participant.|6 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430111|NCT01009203|Secondary|Toxicity Profile|Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.|3 years|Participants who received t least one dose of on-study treatment|||participants|||Number
1430093|NCT01009554|Secondary|Change in Tooth Color as Represented by ΔE at 4 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|4 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430094|NCT01009554|Primary|Oral Tissue Tolerance|Oral tissue tolerance was assessed by oral tissue adverse events for which the relationship to treatment was considered as possible, probable, or very likely. If the relationship to treatment was missing, the adverse event was categorized as a treatment-related adverse event.|through 8 weeks|Analysis was based on the Safety Analysis Set, defined as all participants who used at least one dose of investigational product.|||percentage of participants|||Number
1430095|NCT01009554|Primary|Change in Tooth Color as Represented by ΔE at 8 Weeks Post Baseline From the CIElab Assessment|The tooth color of the four maxillary incisor teeth (teeth #7-10, facial surface) was measured instrumentally using the MHT SpectroShade System. Assessments were made under standardized lighting conditions after participants brushed their teeth with water. The aperture tip was placed perpendicularly to the facial surface of the tooth and the color measured using the CIElab color system. The changes in the individual L*, a*, and b* color parameters were calculated to determine quantitatively the improvements in tooth lightness, redness, and yellowness, respectively. An overall change in tooth color was calculated using the CIE color equation ΔE = [(ΔL*)^2 + (Δa*)^2 + (Δb*)^2]^1/2. The ΔE was calculated per tooth and then averaged over the teeth for a participant.|8 weeks|Analysis was based on the Full Analysis Set, defined as all randomized participants who used the investigational product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1430096|NCT01009515|Secondary|Time to Progression|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|The 16 patients who completed treatment were evaluable for progression-free survival.|||weeks||95% Confidence Interval|Median
1430097|NCT01009515|Secondary|Safety Profile|All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.|Up to 30 days after last on-study treatment, for up to 2 years|All patients who had received at least one dose of on-study treatment were evaluable for toxicity.|||participants|||Number
1430098|NCT01009515|Secondary|Overall Survival|The time from treatment initiation to death by any cause.|2 years|The 16 patients who completed treatment were evaluable for survival analysis.|||weeks||95% Confidence Interval|Median
1430099|NCT01009515|Primary|Objective Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.|6 months|The 16 patients who completed treatment were evaluable for the endpoint of overall response rate.|||participants|||Number
1430100|NCT01009463|Secondary|Change From Baseline in Trough FEV1 at Week 52 (Visit 11)|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour post-dose FEV1 assessment, which was obtained at each visit. Analysis performed using a repeated measures model with covariates of treatment, smoking status at Screening (stratum), baseline (pre-dose Day 1), centre grouping, Week, Week by Baseline, and Week by treatment interactions.|Baseline to Visit 11 (Week 52)/Early Withdrawal|ITT Population. Number of participants presented represent those with data available at the time point being presented, however all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1430112|NCT01009203|Primary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.|3 years||||Months||Full Range|Median
1430161|NCT01008995|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.|Scores could range from 0 (mild) to 72 (severe).|Baseline (Week 0) to Week 12|All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received.|||Participants|||Number
1430101|NCT01009463|Secondary|Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean|The annual rate of COPD exacerbations during the treatment period (per participant per year) that required systemic/oral corticosteroids was assessed. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptom (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate, and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the participant. Mild exacerbations were not associated with the use of oral corticosteroids or antibiotics. Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
1430102|NCT01009463|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|Time to first occurrence analyzed by using a Cox proportional hazards model with covariates of treatment, smoking status at screening (stratum), baseline disease severity (pre-dose Day 1 % predicted FEV1) and centre grouping. An exacerbation of COPD is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. A moderate exacerbation is defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that required treatment with in-patient hospitalization. The number of participants with a moderate or severe COPD exacerbation while on treatment are presented.|From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal|ITT Population|||Participants|||Number
1430103|NCT01009463|Primary|Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean|The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.|From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal|Intent-to-Treat (ITT) Population: all par. randomized who received at least 1 dose of study drug and with available data for analysis. Analysis used a negative binomial regression model with covariates of trt, smoking status at Screening, Baseline pre-dose Day 1 % predicted FEV1 and region and with logarithm of time on trt as an offset variable.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
1430104|NCT01009346|Secondary|Progression Free Survival (PFS) of RAD001 in Combination With Weekly Cetuximab and Cisplatin.|Median number of months for which participants are free of progression after initiating treatment with RAD001 in combination with weekly cetuximab and cisplatin.|2 years|Only 5 patients received at least one cycle of RAD001|||months||95% Confidence Interval|Median
1430105|NCT01009346|Primary|Maximum Tolerated Dose (MTD) of RAD001 in Combination With Cetuximab and Cisplatin.|MTD will be defined as a) the dose of RAD001 producing DLT in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 10mg po qd with less than 33% rate of DLT|6 months|Patients who received at least one cycle of RAD001 were included in the analysis.|||mg|||Number
1430106|NCT01009333|Secondary|Number of Pads Per Day|In a diary, subjects are asked to provide number of pads they used per day.|three weeks||||Pads Per Day||Standard Deviation|Mean
1430107|NCT01009333|Secondary|Number of Voids Per Day|In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.|||Voids Per Day||Standard Deviation|Mean
1430108|NCT01009333|Primary|Number of Urinary Incontinent Episodes Per Day|In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.|three weeks|Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.|||Episodes Per Day||Standard Deviation|Mean
1430109|NCT01009203|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|3 years||||months||Full Range|Median
1430110|NCT01009203|Secondary|Overall Response Rate (ORR)|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses|3 years|Participants evaluable for response|||percentage of evaluable participants|||Number
1446646|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])||Baseline up to Month 7||||percentage of participants|||Number
1430113|NCT01009138|Secondary|Health-care Costs: Medication Intake|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU||||number of daily medications/half year||Standard Deviation|Mean
1430114|NCT01009138|Secondary|Health-care Costs: Non-productive Time|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU||||number of days on sick leave/half year||Standard Deviation|Mean
1430115|NCT01009138|Secondary|Health-care Costs: Health-care Utilisation|Several aspects of interest regarding diabetes-related health-care costs were assessed in order to evaluate potential reductions of health-care costs following the treatment. Measurement was performed using retrospective interview refering to the previous 6 months: The assessed aspects were 1.) the number of out-patient medical appointments as a measure of costs related to health-care utilisation, 2.) the number of days on sick leave as a measure of costs related to non-productive time and 3.) the number of daily taken prescription medications as a measure of costs related to medication intake. For each aspect, the difference of the numbers between baseline and 12 month follow up was calculated.|Baseline, 12 months-FU||||number of medical appointment/half year||Standard Deviation|Mean
1430116|NCT01009138|Secondary|Inflammatory Marker Hs-CRP|The inflammatory marker high sensitivity C-reactive protein (hs-CRP) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU||||mg/dl||95% Confidence Interval|Mean
1430117|NCT01009138|Secondary|Inflammatory Marker IL-1Ra|The inflammatory marker Interleukin 1 receptor antagonist (IL-1Ra) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU||||pg/ml||95% Confidence Interval|Mean
1430118|NCT01009138|Secondary|Inflammatory Marker IL-6|The inflammatory marker Interleukin 6 (IL-6) was assessed as measure of distress-related immune activity. The differences of the serum-concentrations between baseline and 12 month follow up were calculated.|Baseline, 12 month FU||||pg/ml||95% Confidence Interval|Mean
1430119|NCT01009138|Secondary|Glycemic Control (HbA1c)|The HbA1c was used as measure of glycemic control. All blood samples were analysed in a central laboratory using the Bio-Rad II Turbo analyser; the measurement units were %-points. Based on the measurement at baseline and 12-month follow up, the difference of the HbA1c values between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||%-points||Standard Deviation|Mean
1430120|NCT01009138|Secondary|Diabetes Acceptance (AADQ Score)|The Acceptance and Action Diabetes Questionnaire (AADQ) was used to assessment of diabetes acceptance. Using 11 items on diabetes-related experiential avoidance behaviours and a 5-point Likert response scale (1 - 5), the AADQ estimates the overall level of diabetes acceptance. Item scores are summed to a total score between 11 and 55 with higehr scores indicating better acceptance. Based on the measurement of diabetes acceptance at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
1430121|NCT01009138|Secondary|Diabetes Self-Care (SDSCA Score)|The Summary of Diabetes Self-Care Activities Measure (SDSCA) was used to assess diabetes self-care. The SDSCA assesses the number of days of the previous week (0 - 7) on which several specific self-care activities (appropriate diet, physical activity, self-monitoring of blood glucose, foot care) were performed. The item scores are summed and averaged to a total score from 0 to 7 with higher scores indicating better overall self-care. Based on the measurement of diabetes self-care at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
1430122|NCT01009138|Secondary|Diabetes-specific Distress (PAID Score)|The Problem areas in Diabetes Scale (PAID) was used to assess diabetes-specific distress. The PAID assesses diabetes-specific distress using 20 items and a five-point Likert scale (0 - 4). Item scores are summed and transformed to a range from 0 - 100 with higher scores indicating higher distress. Based on the measurement of diabetes-specific distress at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
1430123|NCT01009138|Secondary|Quality of Life (EQ-5D TTO Score)|The EuroQol Five Dimension Questionnaire (EQ-5D) was used to assess health-related quality of life (HRQOL). The EQ-5D assesses five dimensions of HRQOL using a 3-point scale. The item scores are weighted based on population data and used to calculate a standardised total score from 0 to 1 with higher scores indicating better HRQOL. Based on the measurement of HRQOL at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline,12 month FU||||Scores on a scale||Standard Deviation|Mean
1430124|NCT01009138|Primary|Depressive Symptoms (CES-D Score)|The Center for Epidemiologic Studies Depression Scale (CES-D) was used to assess depressive symptoms. The CES-D assesses the frequency of 20 typical symptoms of depression during the previous week on a 4-point Likert scale. Summing of the item scores estimates the total score with a range between 0 and 60 and higher scores indicating more severe depressive mood. Based on the measurement of depressive symptoms at baseline and 12-month follow up, the difference of the test scores between baseline and 12 month follow up was calculated.|Baseline, 12 month FU||||Scores on a scale||Standard Deviation|Mean
1446647|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)||Baseline up to Month 7||||percentage of participants|||Number
1430126|NCT01009086|Secondary|Change From Baseline to Week 24 in Total Modified Van Der Heijde-Sharp (vdH-S) Score for the Combined Radiographic Data From Studies CNTO1275PSA3001 and CNTO1275PSA3002|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. As per protocol, analysis for this outcome measure used pooled data from 2 studies (CNTO1275PSA3001 and PSA3002) because initial power assumptions showed that 900 participants would be required to evaluate impact of ustekinumab on structural damage (SD) progression. The 2 studies, (which had similar study designs and dosing regimens with difference to prior exposure to anti-tumor necrosis factor alpha (TNFα) therapies), were intended to independently measure efficacy in terms of signs, symptoms and physical function, while effects on SD progression is provided from an integrated analysis.|Day 1 (Baseline) and Week 24|Analysis included: (1) combined data from studies CNTO1275PSA3001 (NCT01009086) and CNTO1275PSA3002 (NCT01077362) and (2) all participants randomly assigned to a treatment group.|||Score on a scale||Standard Deviation|Mean
1430127|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 24|"An ACR 70 response is defined as a greater than or equal to 70 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 70 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
1430128|NCT01009086|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 50 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 cm) 4)Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
1430129|NCT01009086|Secondary|Percentage of Participants (With >= 3% Baseline Body Surface Area (BSA) Psoriatic Involvement) Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). A PASI 75 response is defined as greater than or equal to 75 percent improvement in PASI score from baseline.|Week 24|All participants randomly assigned to a treatment group, regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24. Only participants with >=3% baseline BSA psoriatic involvement were included in this analysis.|||Percentage of participants|||Number
1430130|NCT01009086|Secondary|"Change From Baseline to Week 24 in the Disability Index Score as Measured With the Disability Index of the Health Assessment Questionnaire (HAQ-DI)"|The HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ-DI score which ranges from 0 (no disability) to 3 (completely disabled). In psoriatic arthritis, a decrease in score of 0.30 indicates clinically meaningful improvement.|Day 1 (Baseline) and Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Score on a scale||Standard Deviation|Mean
1430131|NCT01009086|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24.|"An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in swollen (66 joints) and tender (68 joints) joint counts and greater than or equal to 20 percent improvement in 3 of the following 5 assessments: 1) Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm), 2) Participant's global assessment of disease activity by VAS (0-10 cm), 3) Physician's global assessment of disease activity by VAS (0-10 centimeters [cm]) 4) Participant's assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas) and 5) C reactive protein."|Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment. For early escape, data at or prior to Week 16 were carried forward through Week 24.|||Percentage of participants|||Number
1430132|NCT01009060|Secondary|Plasma Concentrations of GSK239512 (Cmax) at Steady State After Repeat Dosing on Dose Review Visit at Any Time On-treatment|One Pharmacokinetic (PK) sample was collected within 15 minutes prior to the start of the CSSB and one PK sample was collected within 15 minutes after completion of the CSSB. ‘n’ was the number of samples available for analysis.|15 minutes prior to start and 15 minutes after completion of CSSB at Week 1,2,3,4,5,6 and 7|PK-concentration population included all par. for whom a PK sample was obtained and analyzed. Number of units analyzed are number of samples available for analysis.|||nanograms per milliliter (ng/mL)|Plasma sample|Geometric Coefficient of Variation|Geometric Mean
1430560|NCT01005316|Secondary|Percentage of Participants With the Presence of Anti-MICA Antibodies by Luminex TM Assay|Major histocompatibility complex class I chain-related gene A (MICA) is an antigen that is a potential marker of rejection. Luminex TM assay was used to detect its presence.|Pre-Transplantation|Transplanted Participants|||percentage of participants|||Number
1430134|NCT01009060|Secondary|Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment|Clinical chemistry parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Creatinine, Direct Bilirubin, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Sodium, Total Bilirubin, Total protein, Urea/ Blood urea nitrogen (BUN) were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.|Up to Day 59|Safety Population. Only those par. available at the indicated time point were analyzed.|||Participants|||Count of Participants
1430135|NCT01009060|Secondary|Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment|Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Hemoglobin concentration (MCHC), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red blood cell count (RBC), Reticulocytes, Neutrophils count and White blood cell (WBC) count were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.|Up to Day 59|Safety Population. Only those par. available at the indicated time point were analyzed.|||Participants|||Count of Participants
1430136|NCT01009060|Secondary|Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range|Heart rate readings were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the participant got discharged. It was measured in both supine and standing position. For both Std and Sup positions, heart rate data of concern was <50 or >100 and IFB >=30; <50 or >100 and DFB >=30. Data with only abnormal values were presented.|Up to Day 59|Safety Population. Only those par. available at the specified time points were analyzed.|||Participants|||Count of Participants
1430137|NCT01009060|Secondary|Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range|Blood pressure readings both systolic and diastolic were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the par. got discharged. Blood pressure was measured in both standing (Std) and supine (Sup) position. Data with only abnormal values were presented. For SBP the data of concern was <90 or >140 and increase from Baseline (IFB) >=40; <90 or >140 and decrease from Baseline (DFB) >=30. For DBP the data of concern was <50 or >90 and IFB >=30; <50 or >90 and DFB >=20.|Up to Day 59|Safety Population. Only those par. available at the specified time points were analyzed.|||Participants|||Count of Participants
1430138|NCT01009060|Secondary|Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings|Triplicate 12-lead ECGs were obtained at Baseline (screening visit). Single 12-lead ECGs were obtained at each subsequent time point during the study. Abnormal ECG findings were presented for the most severe on-treatment result.|Up to Day 59|Safety Population. Only those participants who showed most severe on-treatment abnormal ECG findings are presented.|||Participants|||Count of Participants
1430139|NCT01009060|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Day 59|Safety Population consisted of all randomized par. who took at least one dose of investigational product.|||Participants|||Count of Participants
1430140|NCT01009060|Secondary|Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7|The UPSA is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains- comprehension and planning, finance, communication, mobility and house management. When combined, measures functional capacity. The comprehension and planning ranges from 0 to 14, the finance ranges from 0 to 11, the communication ranges from 0 to 12, the mobility ranges from 0 to 9, and the house management ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was score at a given time post Baseline minus Baseline score|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1430141|NCT01009060|Secondary|Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7|The SANS was a tool used to assess five symptom complexes to obtain clinical ratings of negative symptoms in par. with schizophrenia. Complexes include: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. Assessment was conducted on six-point scale (0=not at all to 5=severe) for a total scoring range of 0-120. Lower scores represent better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1430142|NCT01009060|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7|BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; lower score is 18 and highest score is 126. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1430561|NCT01005316|Secondary|Percentage of Participants -Quantification of Anti-HLA IgG Antibodies by Luminex SA Testing|Quantification of anti-HLA IgG antibodies is measured in mean fluorescence intensity (MFI). The maximum MFI for the given subject is provided.|Pre-transplantation|Transplanted Participants|||percentage of participants|||Number
1430143|NCT01009060|Secondary|Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7|MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants at indicated time point were analyzed.|||T-scores||Standard Error|Least Squares Mean
1430144|NCT01009060|Secondary|Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7|The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.|Baseline and Week 7|ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.|||Scores on a scale||Standard Error|Least Squares Mean
1430145|NCT01009060|Secondary|Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7|MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.|Baseline and Week 7|ITT Population. Only those participants available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1430146|NCT01009060|Primary|Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512|The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.|Baseline and up to Week 7|ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.|||Scores on a scale||Standard Error|Least Squares Mean
1430147|NCT01009047|Secondary|Number of Participants With PANSS Response|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Participants|||Number
1430148|NCT01009047|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182|The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a Scale||Standard Deviation|Mean
1430192|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2|Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
1430149|NCT01009047|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182|"The CGI-S rating scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Full Range|Median
1430150|NCT01009047|Secondary|Number of Participants With Clinical Stability|Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.|Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Participants|||Number
1430151|NCT01009047|Secondary|Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
1430152|NCT01009047|Secondary|Change From Baseline in Other Marder Factors Scores at Day 56 and 182|The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.|Baseline, Day 56 and 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
1430153|NCT01009047|Secondary|Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182|The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Day 56 and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
1430154|NCT01009047|Secondary|Change From Baseline in PANSS Total Score at Day 182|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 182|The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
1430155|NCT01009047|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56|The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Day 56|The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Deviation|Mean
1430156|NCT01009034|Secondary|Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.||6 months||||h*mg/L||Inter-Quartile Range|Median
1430157|NCT01009034|Secondary|Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval|For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample||||ratio||Inter-Quartile Range|Mean
1430158|NCT01009034|Primary|Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Speciﬁ- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2–6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.|Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.|We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals.|||Inhibitory concentration ratio||Inter-Quartile Range|Median
1430162|NCT01008969|Secondary|Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection. The imaging studies qualitatively detected radiotracer distribution within the prostate and local lymphatic system. The detection of the radiotracer distribution was performed by experienced attending nuclear medicine physicians at UCSF. The qualitative detection includes visual lymph node uptake seen by SPECT scans overlaid on coregistered CT scans.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. We calculated the percentage of images with detectable lymph nodes from SPECT/CT images in these participants.|||percentage of images identifying LNs|||Number
1430163|NCT01008969|Primary|Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection|Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.|1 day|We reviewed the imaging results of this procedure by SPECT/CT. Percentage of participants who received SPECT/CT scans of 99mTc-sulfur nanocolloid was analyzed.|||Percentage of Participants|||Number
1430164|NCT01008943|Primary|Number of Participants That Experienced AMDC Product-related Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.~No adverse events reported during the study were adjudicated as AMDC product-related."|12 months||||participants|||Number
1430165|NCT01008943|Primary|Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days||||events|||Number
1430166|NCT01008943|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.|30 days||||participants|||Number
1430167|NCT01008943|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.|at biopsy or between biopsy and treatment, approximately 6 weeks|One patient experienced procedural dizziness.|||participants|Participants||Number
1430168|NCT01008904|Secondary|Difference in Quality of Life|Mayo Clinic Uniscale instrument (6 questions with each question rating 0=as bad as it can be and 10=as good as it can be). A lower score is considered to be a better outcome.|from baseline to week 5|Participants who completed treatment|||units on a scale||Standard Error|Mean
1430169|NCT01008904|Primary|Percent Difference in Hot Flash Activity (Score) Between Baseline and End of Treatment (Week 5)|Hot flash score (frequency x severity) at baseline was compared to the end of treatment. The number of flashes in a 24 hour day and a score combining the number and severity of hot flashes (ie, 1 point for mild, 2 points for moderate, 3 points for severe and 4 points for very severe.|from baseline to week 5|25 patients completed the complete study and were analyzed|||percentage of difference||Standard Error|Mean
1430170|NCT01008722|Secondary|Termination or Slowing of Atrial Fibrillation During Ablation|Using data from electrophysiological study, to determine termination of AF into sinus rhythm or organized atrial tachycardia. or slowing by 10% in cycle length measured on the coronary sinus.|acute||||Participants|||Count of Participants
1430171|NCT01008722|Primary|Survival Free of Atrial Fibrillation|Using data from cardiac implanted devices when possible, with recurrence defined as 1% recurrence, or data from intermittent 24-72 hour ambulatory ECGs, with recurrence defined as >30 seconds.|6 -12 months||||participants|||Number
1430172|NCT01008696|Secondary|Overall Assessment of Study Medication by Investigator|Investigator’s overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad.|Day 57|The FAS included participants who received the study medication at least once and had follow-up data that could be used after the Baseline among the participants meeting the eligibility criteria of this study. LOCF was used. Here, 'N'=participants evaluated for this outcome measure.|||Units on a scale||Standard Deviation|Mean
1430173|NCT01008696|Secondary|Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire|Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping.|Baseline and Day 57|The FAS included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure|||Units on a scale||Standard Deviation|Mean
1430193|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1|Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
1430658|NCT01004614|Primary|Maximum Observed Plasma Concentration (Cmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||ng/mL||Standard Deviation|Mean
1430174|NCT01008696|Primary|Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19|Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers.|Day 57|The Full analysis set (FAS) included participants who received study medication at least once and had follow-up data that could be used after Baseline among participants who met eligibility criteria. Last observation carried forward (LOCF) was used. Here, 'n'=participants evaluated for particular category of this outcome measure.|||Percentage of participants|||Number
1430175|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
1430176|NCT01008618|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Participants|||Number
1430177|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430178|NCT01008618|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430179|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430180|NCT01008618|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430181|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
1430182|NCT01008618|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
1430183|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
1430184|NCT01008618|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
1430185|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
1430186|NCT01008618|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
1430187|NCT01008618|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Days||95% Confidence Interval|Median
1430188|NCT01008605|Secondary|Number of Participants Providing Comments to Any Question on the Participant Assessment Tool|Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
1430189|NCT01008605|Secondary|Time Required to Perform Each Step While Using the Caverject Impulse Delivery System|Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.|Day 1|FAS. Each participant tested one device/dose combination. n = number of participants with available data.|||seconds||Standard Deviation|Mean
1430190|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4|Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
1430191|NCT01008605|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3|Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.|Day 1|FAS. Each participant tested one device/dose combination.|||participants|||Number
1430194|NCT01008605|Primary|Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System|Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (>) 80% overall.|Day 1|Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination.|||percentage of participants|||Number
1430195|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
1430196|NCT01008553|Secondary|Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period|Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective.|Day 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Participants|||Number
1430197|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430198|NCT01008553|Secondary|Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period|The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430199|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430200|NCT01008553|Secondary|Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period|The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1430201|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Double-Blind Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
1430225|NCT01008280|Primary|Number of Heavy Drinking Days Per Two Week Segment|A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male|12 weeks||||Number of heavy drinking days/2 weeks||Standard Error|Mean
1430226|NCT01008280|Primary|Number of Drinks Consumed Per Two Week Segments||12 weeks||||Number of Drinks/2 Weeks||Standard Error|Mean
1430227|NCT01008280|Primary|Number of Drinking Days in the Past Two Weeks||12 Weeks||||Number of Drinking Days/2 weeks||Standard Error|Mean
1430202|NCT01008553|Secondary|Number of Doses of Rescue Treatment Per Day - Titration Period|If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Treatments per day||Standard Deviation|Mean
1430203|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 85 or final evaluation (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
1430204|NCT01008553|Secondary|Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period|The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: “Extremely satisfied”, “Satisfied”, “Neither satisfied nor dissatisfied”, “Dissatisfied” and “Dissatisfied very much”. The results were reported as Category 1 = At least “Neither satisfied nor dissatisfied”, which included participants with general evaluation of “Extremely satisfied” to “Neither satisfied nor dissatisfied”, and Category 2 = At least “Satisfied”, which included participants with general evaluation of “Extremely satisfied” to “Satisfied”.|Day 1 and 29 or final evaluation (Titration period)|The FAS1 population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||Participants|||Number
1430205|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Double-Blind Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported.|Day 27-29 (Titration period) and Day 83-85 (double-blind period)|The FAS population included all the randomly assigned participants with the exception of participants with pre-defined criteria. ‘N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
1430206|NCT01008553|Secondary|Pain Visual Analog Scale (VAS) Score - Titration Period|The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a “100-millimeter (mm) VAS scale” by drawing a slash. The left margin (0 mm) was considered “No pain at all”, and the right margin (100 mm) was considered “Severer pain than this is inconceivable”. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported.|Day 12-14 (Screening period) and Day 27-29 (Titration period)|Full analysis set in Period 1 (FAS1) population included all the randomly assigned participants with the exception of participants with pre-defined criteria. 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable for this measure at given time points.|||mm||Standard Deviation|Mean
1430207|NCT01008553|Primary|Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy|Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.|Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)|Full analysis set (FAS) population included all the randomly assigned participants with the exception of participants with pre-defined criteria.|||Days||95% Confidence Interval|Median
1430208|NCT01008475|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.|Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||months||95% Confidence Interval|Median
1430209|NCT01008475|Secondary|Number of Subjects With Tumor Response|Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.|Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||Subjects|||Number
1430228|NCT01007916|Primary|Comfort Upon Insertion|Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.|4 weeks of wear|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review.|||Units on a Scale||Standard Deviation|Mean
1430210|NCT01008475|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.|Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||months||95% Confidence Interval|Median
1430211|NCT01008475|Secondary|Overall Survival (OS) Time|OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.|Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|ITT analysis set included all the subjects who were randomized into the trial.|||months||95% Confidence Interval|Median
1430212|NCT01008475|Primary|Randomized Part: Progression Free Survival (PFS)|PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.|Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)|Intention-to-treat (ITT) analysis set included all the subjects who were randomized into the treatment groups.|||months||95% Confidence Interval|Median
1430213|NCT01008475|Primary|Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)|DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.|Time from the first dose of study drug up to 2 weeks|Dose-escalation analysis set included subjects who received atleast 1 dose of EMD 525797 and who met atleast 1 of the following: Did not withdraw before the end of DLT evaluation period (2 weeks from 1st drug intake) for reasons other than DLT;those who experienced a DLT during this period and received 1 dose of EMD 525797 as per cohort allocation.|||subjects|||Number
1430214|NCT01008449|Secondary|Subject Satisfaction With Location of Scar|Satisfaction with location of scar was reported by subject using a scale of 1 - 5. A score of 1 would be the worst location of a scar and a score of 5 would be the best location of a scar|at end of follow-up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
1430215|NCT01008449|Secondary|Subject Satisfaction With Comfort With Scar|Scar discomfort satisfaction was reported by subject perception using a scale of 1 - 5. A score of 1 would be the worst comfort and a score of 5 would be the best comfort|at end of follow-up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
1430216|NCT01008449|Secondary|Subject Reported Satisfaction With Appearance of Scar|Subject reported satisfaction of the scar appearance was assessed by using a scale of 1 - 5 with 1 being worst appearance and 5 being best appearance|4 - 6 weeks post delivery||||units on a scale||Inter-Quartile Range|Median
1430217|NCT01008449|Secondary|Post Operative Pain - 72 - 96 Hours Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|72 - 96 hours post delivery||||units on a scale||Inter-Quartile Range|Median
1430218|NCT01008449|Secondary|Post Operative Pain - 4 - 6 Weeks Post Delivery|the visual analog pain scale was used. The range is 0 to 10 for reporting pain: 0 = no pain and 10 = unbearable distress|at end of follow-up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
1430219|NCT01008449|Secondary|Operative Procedure Time.|time for procedure as measured in minutes|Intraoperative, at time of intervention.||||minutes||Inter-Quartile Range|Median
1430220|NCT01008449|Secondary|Composite Cosmesis Score (Stony Brook Scar Evaluation Score - SBSES) Core - SBSES))|The SBSES assessed five scar components: width, height, color, suture marks and overall appearance. Each component was assigned a score of 0 or 1 with a total sum range of 0 (worst) to 5 (best).|at the end of follow up, 4 - 6 weeks post partum||||units on a scale||Inter-Quartile Range|Median
1430221|NCT01008449|Primary|Percent of Subjects With Composite Wound Morbidity.|this outcome measure included a composite of either disruption and/ or infection of the wound at 4 - 6 weeks post partum. The number of subjects experiencing wound disruption and or wound infection at 4 - 6 weeks post delivery was assessed|4-6 weeks post partum||||percentage of subjects|||Number
1430222|NCT01008319|Secondary|Delivery Outcomes|Proportion of participants that delivered a baby based on which protocol they were randomized to.|5 years|Number of participants randomized to each arm.|||Participants|||Count of Participants
1430223|NCT01008319|Secondary|Rate of Ovulation|Rate of ovulation with each dose of clomid within each protocol|5 years|Proportion of subjects that ovulated at each dose of Clomid based on which protocol they were randomized to.|||Participants|||Count of Participants
1430224|NCT01008319|Primary|Time to Ovulation With Each Protocol|We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.|5 years||||days||Standard Error|Mean
1430229|NCT01007942|Secondary|Trastuzumab Blood Concentrations by Leading Dose and Time Point|Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses.|Cycle 3, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.|||ng/ml||Standard Deviation|Mean
1430230|NCT01007942|Secondary|Vinorelbine Blood Concentrations by Leading Dose and Time Point|Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses.|Cycle 2, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.|||ng/ml||Standard Deviation|Mean
1430231|NCT01007942|Secondary|Everolimus Blood Concentrations by Leading Dose and Time Point|Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.|Cycle 2, Day 1|The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.|||ng/ml||Standard Deviation|Mean
1430232|NCT01007942|Secondary|PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)–Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)|PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, & social functioning [EF, PF, & SF]). It contains 30 items & is composed of multi-item scales & single-item measures. These include 5 functional scales (physical, role, emotional, social & cognitive functioning), 3 symptom scales (fatigue, pain, nausea, & vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia & financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest & disclosed here.|Baseline, until disease progression or death up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
1430233|NCT01007942|Secondary|Median Time to Deterioration of the ECOG Performance Status Score|Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, & physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead|baseline, until disease progression or death up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
1430234|NCT01007942|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1430235|NCT01007942|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1430236|NCT01007942|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.|Every 3 months until death up to 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
1430237|NCT01007942|Primary|Progressive-free Survival (PFS) Per Investigator Assessment|PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 6 weeks until disease progression or death which ever occurred first up to about 41 months|The Full Analysis Set (FAS) consisted of all randomized patients.|||months||95% Confidence Interval|Median
1430238|NCT01007838|Secondary|Muscle Strength|Bilateral knee extensor isometric strength.|Change from baseline in muscle strength at 12 weeks|||||||
1430239|NCT01007838|Primary|Muscle Cross Sectional Area|Muscle cross sectional area (quadriceps group) taken at midpoint slice between superior aspect of femoral head and the femoral condyle.|Change from baseline in cross sectional area at 12 weeks|Per protocol. All participants completing the study were analyzed.|||cm2||Standard Deviation|Mean
1430248|NCT01007656|Primary|Direct Bilirubin|Direct bilirubin is referred to as conjugated bilirubin, which is water-soluble. It's taken up by the liver cells and conjugated to form the water-soluble bilirubin diglucuronide. It's used to diagnose and/or monitor liver diseases, such as cirrhosis, hepatitis or gallstones. If direct bilirubin is elevated more than unconjugated bilirubin, there's typically a problem associated with decreased elimination of bilirubin by the liver cells.|90 days||||mg/dL||Standard Deviation|Mean
1430249|NCT01007656|Primary|Alkaline Phosphatase||90 days||||U/L||Standard Deviation|Mean
1430250|NCT01007656|Primary|Albumin||90 days||||g/dL||Standard Deviation|Mean
1430251|NCT01007656|Primary|Uric Acid||90 days||||mg/dL||Standard Deviation|Mean
1430252|NCT01007656|Primary|Total Protein|The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.|90 days||||g/dL||Standard Deviation|Mean
1430253|NCT01007656|Primary|Triglycerides (TG)||90 days||||mg/dL||Standard Deviation|Mean
1430254|NCT01007656|Primary|Serum Glutamic Pyruvate Transaminase (ALT/SGPT)||90 days||||U/L||Standard Deviation|Mean
1430255|NCT01007656|Primary|Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)||90 days||||U/L||Standard Deviation|Mean
1430256|NCT01007643|Secondary|Change in Vastus Medialis Oblique Muscle Strength||3 months|||||||
1430257|NCT01007643|Secondary|Change in Quadriceps Flexibility||3 months|||||||
1430258|NCT01007643|Secondary|Change in Hamstring Flexibility||3 months|||||||
1430259|NCT01007643|Secondary|Changes in Patellofemoral Symptoms||3 months|||||||
1430260|NCT01007643|Primary|Percentage of Exercise Days Completed.|Calculated for the 12 week period as daily exercise completion rate as percentage|3 months|Per Protocol|||percentage of days completed||Full Range|Mean
1430261|NCT01007552|Secondary|Collect Samples at Baseline, Day 8 and Day 43 for Future Biomarker Studies and Development of Profiles of Responders to Anti-VEGF Therapy (Optional)|This was a tissue banking end point of sample collection for future studies. No analysis was completed.|Baseline, day 8 and day 43|No patients were analyzed and no data were collected for this Outcome Measure. This was an optional aim and the research team decided to opted out of analyzing.||||||
1430262|NCT01007552|Secondary|Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43|Mean number of CTCs in 7.5 ml of whole blood|baseline, day 22 and day 43|All treated and eligible patients|||cells||Standard Deviation|Mean
1430263|NCT01007552|Secondary|Assess Overall Survival (OS)||From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Mean
1430264|NCT01007552|Secondary|Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.|"We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life.~For a Detailed description see:~Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy–Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239.~No subscales were analyzed."|Baseline, Day 22 and Day 43|All treated and eligible patients. Some measures were not complete for leading to missing values.|||units on a scale||Standard Deviation|Mean
1430265|NCT01007552|Secondary|Assess the Toxicity of the Regimen.|Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail.|up to 5 years|All treated and eligible patients|||participants|||Number
1430266|NCT01007552|Secondary|Estimate the Proportion of Patients With Clinical Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1430267|NCT01007552|Primary|The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers.|"Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term evaluable in reference to measurability will not be used because it does not provide additional meaning or accuracy."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1430268|NCT01007435|Secondary|Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52|The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
1430287|NCT01007149|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks|Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Liters||Standard Deviation|Mean
1430269|NCT01007435|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52|The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
1430270|NCT01007435|Secondary|Percentage of Participants With a Major Clinical Response at Week 52|A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
1430271|NCT01007435|Secondary|Change From Baseline in Sharp Joint Space Narrowing Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
1430272|NCT01007435|Secondary|Change From Baseline in Modified Sharp Erosion Score at Week 52||Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
1430273|NCT01007435|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.|Baseline to Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Units on a scale||Standard Deviation|Mean
1430274|NCT01007435|Secondary|Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52|Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line “no disease activity” [symptom-free and no arthritis symptoms] and the extreme right end “maximum disease activity”; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line “no pain” and the extreme right end “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.|Baseline to Weeks 24 and 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
1430275|NCT01007435|Secondary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52||Week 52|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
1430276|NCT01007435|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24|A participant has a DAS28 remission response if their DAS28 < 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Week 24|Intent-to-treat population: All randomized participants who received at least 1 tocilizumab/placebo infusion.|||Percentage of participants|||Number
1430277|NCT01007396|Secondary|Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)|"The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation~Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution.~The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml."|3 months after LTBI treatment|Thirteen participants agreed to undergo treatment for latent tuberculosis infection and completed 3 months therapy.|||Percentage of participants|||Number
1430288|NCT01007149|Secondary|Physician and Patient Global Evaluation of Treatment Effectiveness|The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Participants|||Number
1430278|NCT01007396|Primary|Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea|The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).|QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.|Of the 322 healthcare workers (HCWs), 275 (85%) underwent repeat QuantiFERON-TB Gold In-Tube test (QFT-IT test) after 1 year of employment; the 47 participants who had resigned were excluded. Two participants with indeterminate results on the baseline QFT-IT test were excluded from the analysis.|||number of new cases per 1000 person/year|||Number
1430279|NCT01007253|Secondary|Total Number of Eosinophils|The percentage of eosinophils among white blood cells was determined under light microscopy at 1000x magnification, and the total number of eosinophils in each lavage was then calculated. The specimens that had no eosinophils identified on differential counting despite adequate cells on the smear were assigned a number that corresponded to the lowest number of eosinophils on a slide where the number could be counted. That number was 33 total eosinophils.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||eosinophils||Full Range|Median
1430280|NCT01007253|Secondary|Change in Tryptase Level (Across Nasal Challenges)|"Tryptase is an enzyme that is released, along with histamine and other chemicals, from mast cells when they are activated, often as part of an allergic immune response. Tryptase in nasal lavages was measured using the ImmunoCap tryptase assay, by Phadia (Uppsala, Sweden). The limit of detection of the assay is 1.0 ng/mL, and levels below this value were arbitrarily assigned a value of 0.5 ng/mL.~For each patient, tryptase levels recorded after the diluent challenge were subtracted from tryptase levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in tryptase level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||ng/mL||Full Range|Median
1430281|NCT01007253|Secondary|Change in Histamine Level (Across Nasal Challenges)|"Histamines are simple chemical substances produced by immune system cells when reacting to an antigen in response to foreign invaders like germs and bacteria.~Histamine in nasal lavages was measured using a histamine enzyme immunoassay kit market by SPI-BIo, Bertin Pharma (Montigny le Bretonneux, France). The limit of detection of the assay is 0.4 nM, and levels below the detection limit were arbitrarily assigned a value of 0.2 nM. Samples that yielded values above the upper detection limit of the assay were diluted and reassayed.~For each patient, histamine levels recorded after the diluent challenge were subtracted from histamine levels recorded after each of the three nasal challenges. These differences were added across challenges, yielding the total change in histamine level reported in this outcome for each patient."|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||nM||Full Range|Median
1430282|NCT01007253|Secondary|Total Number of Sneezes||50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||sneezes||Full Range|Median
1430283|NCT01007253|Secondary|Total Nasal Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one nostril and was asked to rate nasal symptoms (congestion, rhinorrhea, and itchy nose/throat) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of nasal symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other nostril. The outcome is the total number of score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (congestion, rhinorrhea, and itchy nose/throat), and nostrils (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||units on a scale||Full Range|Median
1430284|NCT01007253|Primary|Total Eye Symptoms Score Difference|After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other eye. The outcome is the total of the score differences (i.e. score after each dose subtracted by diluent challenge score) summed across doses, symptoms (watery and itchy), and eyes (left and right). Thus, each participant's total score is an integer value ranging from -36 to 36.|50 minutes [duration of 3 nasal challenges and 2 washout periods]|One subject was removed from the study due to upper respiratory tract infection, reducing the number of evaluable subjects from 21 to 20.|||units on a scale||Full Range|Median
1430285|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI|||Percent change in MFI||Standard Deviation|Mean
1430286|NCT01007149|Secondary|Number of Patients With at Least One Asthma-related Event Over 16 Weeks|Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.|16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Participants|||Number
1430289|NCT01007149|Secondary|Change From Baseline in Nasal Symptom Global Score and Individual Components|Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Score units||Standard Deviation|Mean
1430290|NCT01007149|Secondary|Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)|The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.|Baseline and 16 weeks|Intent to Treat Population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment|||Score units||Standard Deviation|Mean
1430291|NCT01007149|Secondary|Change From Baseline in Induced Sputum Eosinophil Count|The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.|Baseline and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. Only patients with measurements at both baseline and week 16 were included in this analysis.|||Percentage of total nonsquamous cells||Standard Deviation|Mean
1430292|NCT01007149|Secondary|Change in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.|Baseline and 4, 8, 12 and 16 weeks|Intent to Treat population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment. During different time points, participants with observations at that time point were included in the analysis.|||parts per billion (ppb)||Standard Deviation|Mean
1430293|NCT01007149|Primary|Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils|Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.|Baseline and 16 weeks|Intent to Treat FcεRI analyzable population - all randomized patients who received at least one dose of study drug and had at least one post-baseline efficacy assessment, and who had a valid baseline and post-treatment measurement of FcεRI|||Percent change in MFI||Standard Deviation|Mean
1430294|NCT01007123|Secondary|Straining Change From Baseline|Daily assessment of straining. Min value: 1. Max value: 5. Higher value indicates more straining.|Baseline and during 8 weeks of treatment|ITT population|||units on a scale (1-5)||Standard Error|Least Squares Mean
1430295|NCT01007123|Secondary|LDL/HDL Ratio|Ratio of plasma LDL cholesterol and HDL cholesterol Difference from baseline, placebo-adjusted|Baseline and 8 weeks of treatment|ITT population|||Ratio||Standard Error|Least Squares Mean
1430296|NCT01007123|Secondary|Stool Consistency Change From Baseline|Bristol Stool Form Scale. Min value:1. Max value: 7. Higher value indicates more liquid shape than normal, lower indicates constipated state.|Baseline, weekly and up to 8 weeks|ITT population|||units on a scale (1-7)||Standard Deviation|Least Squares Mean
1430297|NCT01007123|Secondary|Time to First Bowel Movement||First week|ITT population|||hours||95% Confidence Interval|Median
1430298|NCT01007123|Secondary|Responder Analyses for Complete Spontaneous Bowel Movements (CSBMs)|"A CSBM responder is defined as per FDA draft guidance for IBS-C:~An increase of one or more of CSBMs per week over baseline for at least 4 out of the 8 weeks of treatment"|Baseline, weekly and up to 8 weeks|ITT population|||participants|||Number
1430299|NCT01007123|Primary|Change From Baseline in Frequency of Spontaneous Bowel Movements|Primary ep W 1|Baseline, weekly, up to 8 weeks|ITT population|||Number of SBMs||Standard Error|Least Squares Mean
1430300|NCT01007110|Secondary|Cardiac Conduction Time||Change from Baseline to 2 Months Post-natal||||milliseconds||Standard Deviation|Mean
1430301|NCT01007110|Secondary|Cord Blood Phospholipids DHA|Newborn red blood cell phospholipids collected at birth.|Birth||||weight percent total fatty acids||Inter-Quartile Range|Median
1430302|NCT01007110|Secondary|Maternal Red Blood Cell (RBC) Phospholipids at Delivery|Maternal red blood cell phospholipid collected at delivery. These results were compared to baseline red blood cell phospholipid that was collected at study enrollment. A weighed standard fatty acid mixture (Supelco 37 component fatty acid methyl ester mix,Sigma Aldrich) was employed to correct final DHA weight percent of total fatty acids (wt%TFA).|Time of delivery, 36 weeks to term||||weight percent Total Fatty Acids||Inter-Quartile Range|Median
1430303|NCT01007110|Secondary|Neonatal Behavioral Assessment Scale (NBAS) Scores|"The Neonatal Behavioral Assessment Scale (NBAS) measure 6 areas.~For behavioral items a higher score corresponds to more desirable outcomes:~Habituation: Sum of scores across 3 items, scored on a scale of 1-9. Range: 3-27.~Orientation: Sum of scores across 7 items, scored on a scale of 1-9. Range: 7 – 63.~Motor: Sum of scores across 5 items; 3 scored on a scale of 1-9, 1 scored on a scale of 1-6, and 1 scored on a scale of 1-5. Range: 5-38.~Range of State: Sum of scores across 4 items; 2 scored on a scale of 1-6 and 2 scored on a scale of 1-5. Range: 4-22.~Regulation of State: Sum of scores across 4 items, scored on a scale of 1-9. Range: is 4-36.~Autonomic Stability: Sum of scores across 3 items; 1 scored on a scale of 1-9, 1 on a scale of 1-8, and 1 on a scale of 1-6. Range: 3-23.~Reflexes: Sum across the 18 items, scored on a scale of 0-3. Range: 0 to 54. The supplementary items are each scored on a scale of 1-9 and do not combine to form a composite."|within 2 weeks of delivery||||units on a scale||Standard Deviation|Mean
1430667|NCT01004393|Secondary|Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
1430304|NCT01007110|Primary|Heart Rate|Mean fetal heart rate calculated from the magnetocardiogram recorded at 24, 32 and 36 weeks gestational age.|24, 32 and 36 weeks gestational age|"Placebo: 19 subjects @ 24 wks GA, 25 subjects @ 32 wks GA, 24 subjects @ 36 wks GA~DHA: 21 subjects @ 24 wks GA, 23 subjects @ 32 wks GA, 22 subjects @ 36 wks GA"|||Beats per minute||Standard Deviation|Mean
1430305|NCT01007071|Secondary|Neuropsychological Testing of Executive Function|Executive function was assessed in part B of the 2-part Trail Making Test. In Part A, 25 circles are distributed over a sheet of paper, numbered 1 - 25, and the patient draws lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient is instructed to connect the circles as quickly as possible. The amount of time the patient takes to connect the circles is recorded as their score. If patients make an error, they are corrected then continue from the last correct circle. The number of seconds for completion of part B is reported, therefore higher scores reveal greater impairment.|16 weeks||||seconds||Standard Deviation|Mean
1430306|NCT01007071|Primary|BOLD Signal Measured by Functional MRI Scan to Functional Connectivity Measured by fMRI|Functional MRI scans were to be performed at baseline and at 16 weeks. Changes in functional connectivity before and after 16 weeks of treatment were analyzed. The analysis involved approximately 40,000 paired sample t-tests. The dependent variable here for each subject is the correlation between the BOLD timeseries in the seed region (posterior cingulate cortex) and the BOLD timeseries in a given, standard space, brain voxel. This paired-sample t-test is run, separately, for every voxel in the brain. The pre-specified Outcome Measure intended to report the number of voxels that showed significant changes with active treatment. A preliminary analysis was conducted using a paired-sample t-test at each of the 40,000+ voxels, however, none of the voxels reached the level of significance. Since no significant voxels were detected, subsequent planned analyses were not performed, and summary level data cannot be reported for this Outcome Measure.|Baseline and 16 weeks|Preliminary analysis did not work as intended and subsequent data were not collected from any participants (please see the detailed explanation in the Measure Description).||||||
1430307|NCT01006980|Secondary|Pre and Post-dose Plasma Vemurafenib Concentration by Study Day|The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.|Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).|"The pharmacokinetic (PK) analysis population included all participants who received vemurafenib and provided valid PK assessments. The PK population at specific time points varied depending on the availability of confirmed dosing and PK assessment times. n indicates the number of participants with available PK data at each time point."|||μg/mL||Standard Deviation|Mean
1430308|NCT01006980|Secondary|Number of Participants With Adverse Events (AEs)|The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.|From randomization (initiated January 2010) until December 30, 2010.|The safety population was defined as all treated participants who had at least one on-study assessment. The safety population was analyzed according to the treatment received.|||participants|||Number
1430309|NCT01006980|Secondary|Time to Treatment Failure|Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.|approximately 3 years|||||||
1430310|NCT01006980|Secondary|Time to Confirmed Response|Time to response was defined as the time from randomization to confirmed response (complete response or partial response).|From randomization (initiated January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.|||months||Full Range|Median
1430311|NCT01006980|Secondary|Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan–Meier method.|From randomization (initiated in January 2010) until December 30, 2010.|The analysis population included all participants randomized by September 22, 2010 and with a best overall confirmed response of complete response or partial response.|||months||95% Confidence Interval|Median
1430312|NCT01006980|Secondary|Participants With a Best Overall Response (BOR) of Complete Response or Partial Response|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.|From randomization (initiated January 2010) until December 30, 2010|The analysis population consisted of all ITT participants randomized by September 22, 2010 (at least 14 weeks prior to the clinical cutoff date of December 30, 2010). The 14-week interval was chosen as it was the minimum time needed to observe a confirmed overall response according to protocol-specified schedule for the first two tumor assessments.|||participants|||Number
1430313|NCT01006980|Primary|Progression-free Survival|A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).|From randomization (initiated January 2010) to December 30 2010.|The analysis population for PFS consisted of all ITT participants randomized by October 27, 2010 (at least 9 weeks prior to the clinical cutoff date of December 30, 2010). The 9-week interval was chosen to allow time for participants to have had their first scheduled post baseline tumor assessment CT scan.|||participants|||Number
1430314|NCT01006980|Primary|Overall Survival|An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.|From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).|The intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.|||participants|||Number
1430315|NCT01006967|Secondary|Change in Activities-specific Balance Confidence From Baseline|The Activity-specific Balance Confidence scale (ABC) is a patient self-report measure tthat measures the subject’s self-assessed confidence in being able to perform 16 specific activities without losing their balance or becoming unsteady. For each task (i.e. walking around the house, sweeping the floor, walking outside on an icy sidewalk) the subject indicates their level of confidence in doing the activity without losing their balance. For items the subject does not normally perform, they are asked to try and imagine how confident they would feel if they had to do the activity. For subjects who normally use a walking aid to do the specific activity, they are asked to rate their confidence as if they were using these supports. Each item is rated 0-100 for each item. To obtain the final score, the ratings are averaged across the 16 items to produce an overall score from 0-100 with higher scores indicated greater balance confidence.|End of Treatment||||units on a scale||Standard Deviation|Mean
1430316|NCT01006967|Secondary|Change in Dynamic Gait Index From Baseline|The Dynamic Gait Index (DGI) is another instrument that was developed to assess the likelihood of falling in older adults and tests eight facets of gait. The DGI takes about 15 minutes and requires the following equipment: a Box (Shoebox); 2 Cones; Stairs; and a 20’ walkway that is 15” wide. Each item is scored on a four-point ordinal scale, ranging from 0-3 where “0” indicates the lowest level of function and “3” the highest level of function, resulting in a total score of 0 to 24. The interpretation guidelines state that a score < 19/24 is predictive of falls in the elderly while as score of > 22/24 indicate safe walkers. The outcome reported is the change in the DGI between baseline and end-of-treatment.|End of Treatment||||units on a scale||Standard Deviation|Mean
1430317|NCT01006967|Secondary|Change in Berg Balance Scale From Baseline|The Berg Balance Measure (Berg) was designed to test an elderly patient’s level of balance. The test consists of 14 balance items that have been deemed safe for elderly patients to perform. The Berg is a task performance exam that takes about 15 to 20 minutes to complete. The test is scored while it is administered. Each of the independent items are scored on a five point ordinal scale where 0 indicates the patient’s inability to perform the task and 4 represents independence; the individual points are then summed to achieve a total score (range 0 - 56). The higher the patient’s score on the Berg the more independent the patient. The reported outcome is the change in the Berg between baseline and end of treatment.|End of Treatment||||units on a scale||Standard Deviation|Mean
1430318|NCT01006967|Secondary|Change in Timed Up and Go From Baseline||End of Treatment||||seconds||Standard Deviation|Mean
1430319|NCT01006967|Primary|Number of Subjects Reporting a Fall-related Injury||3 months||||Participants|||Count of Participants
1430320|NCT01006967|Primary|Number of Subjects Reporting Any Fall||3 months||||Participants|||Count of Participants
1430321|NCT01006889|Secondary|Change in Anthropometric Variables (BMI).||6 months|The number of participants included were the ones that completed the study.|||Kg/m2||Standard Deviation|Mean
1430322|NCT01006889|Secondary|Lipid Profiles, Lipoprotein Analysis by NMR (LipoScience).|Change in lipid levels vs. pretreatment.|6 months|Number of patients completing.|||mg/dl||Standard Deviation|Mean
1430323|NCT01006889|Secondary|Percent Change From Baseline in Glucose Infusion (M Value) During Hyperglycemic Clamp|M value represents glucose infusion change|6 months|The number of participants included were the ones that completed the study.|||percentage change vs pretreatment||Standard Deviation|Mean
1430324|NCT01006889|Secondary|Insulin Secretion (Hyperglycemic Clamp)|Change in C-peptide levels vs. pretreatment in the first and second phase.|6 months|The number of participants included were the ones that completed the study.|||ng/ml||Standard Deviation|Mean
1430325|NCT01006889|Secondary|Number of Severe Hypoglycemic (Glucose ≤40 mg/dL) Events.||6 months|The number of participants included were the ones that completed the study.|||number of events|||Number
1430326|NCT01006889|Secondary|Change in Anthropometric Variables (Weight).||6 months|The number of participants included were the ones that completed the study.|||Kg||Standard Deviation|Mean
1430327|NCT01006889|Secondary|A1c|Patients with controlled T2DM with bedtime insulin alone (n=5) or bedtime insulin and premeal rapid-acting insulin novolog (n=15) had eventide given twice daily for 6 months (if on premeal insulin it was stopped). The goal is to assess if adding SQ exenatide is effective to maintain optimal glycemic control in this population.|6 months|The number of participants included were the ones that completed the study.|||percentage of A1c||Standard Deviation|Mean
1430328|NCT01006889|Primary|Hepatic Steatosis|Hepatic steatosis was assessed non-invasively by MRS.|6 months|The number of participants included were the ones that completed the study.|||Percentage of liver fat||Standard Deviation|Mean
1430329|NCT01006707|Secondary|Subjective Opioid Withdrawal Scale (SOWS) Score 20 Minutes Following Ondansetron or Placebo Administration|The SOWS consists of 16 physical and emotional symptoms that are rated by the participant on a scale from 0 (not at all) to 4 (extremely), to indicate the extent to which the symptom describes how they are feeling at the time. The total SOWS score is determined by summing the scores of the 16 items. Scores range from a low of 0 to a high of 64. A score of 0 would suggest that the individual is experiencing no symptoms of withdrawal while a score of 64 would suggest that the individual is experiencing all 16 symptoms of withdrawal to the fullest extent possible.|20 minutes following Ondansetron or Placebo administration|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
1430468|NCT01005888|Secondary|Average Severity of HAE Attacks During Each Prophylactic Therapy Period|All attacks in each therapy period were assigned a value of 1 (mild), 2 (moderate), or 3 (severe). Attack severity was considered the highest value assigned by the subject to any swelling location during the attack. Average severity was set to 0 if there was no attack in a period.|12 weeks|Efficacy Dataset.|||units on a scale||Standard Deviation|Mean
1430330|NCT01006707|Secondary|Objective Opioid Withdrawal Scale Score 15 Minutes Following Ondansetron or Placebo Administration|The OOWS consists of 13 observable physical symptoms that are assessed over a five-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from a low of 0 to a high of 13. A score of 0 would suggest that no objective signs of withdrawal were observed while a score of 13 would suggest that every observable sign of withdrawal was observed.|15 Minutes Following Ondansetron or Placebo Administration|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
1430331|NCT01006707|Secondary|Objective Opioid Withdrawal Scale Score 5 Minutes Following Ondansetron or Placebo Administration|The OOWS consists of 13 observable physical symptoms that are assessed over a five-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from a low of 0 to a high of 13. A score of 0 would suggest that no objective signs of withdrawal were observed while a score of 13 would suggest that every observable sign of withdrawal was observed.|5 Minutes Following Ondansetron or Placebo Administration|Participants completing the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
1430332|NCT01006707|Primary|Brain Regions With Increases or Decreases in Amplitude of Low Frequency Fluctuations (ALFF) Associated With Ondansetron Administration|Changes are reporting using Spearman's correlation coefficient, using within-subject factors of time (pre-naloxone, post-naloxone) and pre-treatment (placebo, ondansetron). Changes in Objective Opioid Withdrawal Scale (OOWS) and Subjective Opioid Withdrawal Scale (SOWS) with correlation coefficient >0.45 are reported. The OOWS consists of 13 observable physical symptoms assessed over a 5-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores is determined by summing the scores of the 13 items. OOWS scores can range from 0 to 13; lower scores correspond to fewer symptoms. SOWS consists of 16 physical and emotional symptoms rated by the participant on a scale from 0 (not at all) to 4 (extremely), to indicate the extent to which the symptom describes how they are feeling at the time. The total SOWS score is determined by summing the scores of the 16 items. Scores range from 0 to 64; lower scores correspond to fewer symptoms.|36 minutes||||correlation coefficient|||Number
1430333|NCT01006655|Primary|Adenosine Challenge Test|Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded|ten weeks||||mg/ml||Standard Deviation|Mean
1430334|NCT01006629|Secondary|Total Days of Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
1430335|NCT01006629|Secondary|Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||participants|||Number
1430336|NCT01006629|Secondary|Total Days of RSV ICU Stay|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
1430337|NCT01006629|Secondary|Number of Intensive Care Unit (ICU) Admissions During RSV Hospitalization|Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||participants|||Number
1430338|NCT01006629|Secondary|Total RSV Hospitalization Days With Increased Supplemental Oxygen Requirement|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
1430339|NCT01006629|Secondary|Total Number of RSV Hospitalization Days|All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.|Through 30 days following the last injection of palivizumab||||days||Standard Deviation|Mean
1430340|NCT01006629|Primary|Number of Hospitalizations Due to Respiratory Syncytial Virus (RSV)|Number of subjects experiencing an RSV hospitalization|Through 30 days following the last injection of palivizumab||||participants||95% Confidence Interval|Number
1430341|NCT01006629|Primary|Frequency of Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.|Through 30 days following the last injection of palivizumab||||participants|||Number
1430342|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Any Type of Infection|The percentage of participants who experienced an AE related to any type of infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.|||Percentage of Participants|||Number
1430343|NCT01006616|Secondary|Percentage of Participants Who Experienced an AE Related to Respiratory Infection|The percentage of participants who experienced an AE related to a respiratory infection or infestation, was to be calculated for the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment.|Up to 26 , 52 and 104 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 104 weeks.|||Percentage of Participants|||Number
1430668|NCT01004393|Secondary|Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
1430344|NCT01006616|Secondary|Change From Baseline in Percent of Arterial Oxygen Saturation Measured by Pulse Oximetry Before and After the 6-Minute Walk Test|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. Percent (%) of arterial oxygen saturation, as measured by pulse oximetry, was to be assessed before and after the 6-minute walk test at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test arterial oxygen saturation. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Percent Oxygen Saturation||Standard Error|Least Squares Mean
1430345|NCT01006616|Secondary|Change From Baseline in Pre- and Post-6-Minute-Walk-Test Borg Scale Score|The 6-minute walk test measured the distance participants could walk quickly on a flat, hard surface in 6 minutes. The Borg scale is a method use to rate perceived exertion (0=Nothing at all [no exertion] to 10=Maximal [exertion]). Borg scale scores were to be assessed pre- and post-walk-test at Baseline, Week 26, Week 52 and Week 104. A higher score indicates greater perceived exertion.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre- and post-6-minute-walk-test Borg scale score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
1430346|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Epithelial Cell-Derived Neutrophil Activating Peptide 78 (ENA-78)|Blood samples were to be collected prior to study drug administration to determine participant plasma ENA-78 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for ENA-78 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||pg/mL||Standard Deviation|Least Squares Mean
1430347|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Plasma Neutrophil Elastase|Blood samples were to be collected prior to study drug administration to determine participant plasma neutrophil elastase levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma neutrophil elastase level. The study was terminated during Period 2; no data were collected for the endpoint at Week 104.|||ng/mL||Standard Deviation|Least Squares Mean
1430348|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Matrix Metallopeptidase-9 (MMP-9)|Blood samples were to be collected prior to study drug administration to determine participant plasma MMP-9 levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||ng/mL||Standard Deviation|Least Squares Mean
1430349|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Myeloperoxidase (MPO)|Blood samples were to be collected prior to study drug administration to determine participant plasma MPO levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||ng/mL||Standard Deviation|Least Squares Mean
1430350|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: Fibrinogen|Blood samples were to be collected prior to study drug administration to determine participant plasma fibrinogen levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma fibrinogen level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||mg/dL||Standard Deviation|Least Squares Mean
1430373|NCT01006616|Primary|Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Period 1)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline and Week 26.|Baseline and Week 26|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26 assessment for post-bronchodilator FEV1.|||Liters||Standard Error|Least Squares Mean
1430351|NCT01006616|Secondary|Plasma Inflammatory Biomarker Levels: High-sensitivity C-reactive Protein (Hs-CRP)|Blood samples were to be collected prior to study drug administration to determine participant plasma hs-CRP levels at Week 26, Week 52 and Week 104. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for plasma hs-CRP level. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||mg/dL||Standard Deviation|Least Squares Mean
1430352|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Matrix Metallopeptidase-9 (MMP-9)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MMP-9 levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for induced sputum MMP-9 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||ng/mL||Standard Deviation|Least Squares Mean
1430353|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Sputum Neutrophil Elastase|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. Neutrophil elastase levels were measured in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum neutrophil elastase level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||ng/mL||Standard Deviation|Least Squares Mean
1430354|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Myeloperoxidase (MPO)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. MPO levels were measured by ELISA in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum MPO level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||ng/mL||Standard Deviation|Least Squares Mean
1430355|NCT01006616|Secondary|Sputum Inflammatory Marker Levels: Interleukin 8 (IL-8)|Induced sputum samples were to be collected from participants via the nebulized method prior to study drug administration at Week 26, Week 52 and Week 104. IL-8 levels were measured by enzyme-linked immunosorbent assay (ELISA) in the sputum supernatant. The reported Baseline LS means and SDs are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an ANOVA method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for sputum IL-8 level. The study was terminated during Period 2; no data were collected for this endpoint at Weeks 52 or 104.|||pg/mL||Standard Deviation|Least Squares Mean
1430356|NCT01006616|Secondary|Change From Baseline in Modified Medical Research Council (MMRC) Dyspnea Score|The MMRC dyspnea scale is used to assess participant breathlessness. The MMRC dyspnea scale consists of five grades that describe almost the entire range of respiratory disability from none (Grade 0=Not troubled with breathlessness except with strenuous exercise) to almost complete incapacity (Grade 4=Too breathless to leave the house or breathless when dressing or undressing). MMRC dyspnea scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for MMRC dyspnea score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
1430374|NCT01006603|Secondary|Change From Baseline to Week 52 in β-cell Function (as Measured by Homeostasis Model Assessment-β [HOMA-β]|β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||percentage of change from baseline||95% Confidence Interval|Mean
1430562|NCT01005316|Secondary|Percentage of Participants With the Presence of Anti-HLA IgG Antibodies by Luminex SA Testing|Luminex SA testing was used to detect the presence of anti-HLA IgG Antibodies for all samples at a central laboratory.|Pre-transplantation|Transplanted Participants|||percentage of participants|||Number
1430357|NCT01006616|Secondary|Change From Baseline in Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Index Score|The BODE index is a composite score assessing COPD prognosis that consists of 4 variables that are individually scored: FEV1 percent predicted, 6-Minute Walk Test, Modified Medical Research Council (MMRC) dyspnea scale and body mass index (BMI). The FEV1 percent predicted was scored from ≥65% (0 points, less airway obstruction) to ≤35% (3 points, greater airway obstruction). The 6-Minute Walk Distance was scored from: ≥350 meters (0 points, good exercise capacity) to ≤149 meters (3 points, poor exercise capacity). The MMRC Dyspnea Scale was scored from: MMRC 0: Dyspneic on strenuous exercise (0 points) to MMRC 4: Cannot leave house; breathless on dressing/undressing (3 points). BMI was scored as: >21 (0 points) and ≤21 (1 point). Variable scores were summed to produce a BODE index score. BODE index scores could range from 0 to 10, with a higher score correlating with an increased risk of COPD mortality. BODE index scores were to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for BODE index score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
1430358|NCT01006616|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF, as measured in liters/minute with a peak flow meter, is the maximum speed of expiration. Participants were to perform at least 3 and up to 5 PEF measurements in the morning before taking study drug. PEF was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for PEF. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters/minute||Standard Error|Least Squares Mean
1430359|NCT01006616|Secondary|Change From Baseline in Inspiratory Capacity (IC)|IC, as measured in liters by body plethysmography, is the maximum amount of air inspired when taking a slow, full inspiration with no hesitation from a position of passive end-tidal expiration (i.e. FRC) to a position of maximal inspiration. IC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for IC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
1430360|NCT01006616|Secondary|Change From Baseline in Total Lung Capacity (TLC)|TLC, as measured in liters by body plethysmography, is the most amount of air lungs can hold at the top of breathing in. TLC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for TLC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
1430361|NCT01006616|Secondary|Change From Baseline in Functional Residual Capacity (FRC)|FRC, as measured in liters by body plethysmography, is the volume of air present in the lungs at the end of passive expiration. FRC was to be assessed after post-bronchodilator spirometry tests were performed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FRC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
1430362|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)|FVC, as measured in liters by spirometry, is the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was to be assessed 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for post-bronchodilator FVC. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
1430363|NCT01006616|Secondary|Change From Baseline in Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity (FEF25%–75%) Test|Mid-Breath Forced Expiratory Flow (FEF25%-75%), as measured in liters/minute by spirometry, is the rate at which participants breathe out air from 25 percent of their breath to 75 percent of their breath. FEF25%-75% was to be assessed at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for FEF25%-75%. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters/minute||Standard Error|Least Squares Mean
1430364|NCT01006616|Secondary|Change From Baseline in Pre-bronchodilator FEV1|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Pre-bronchodilator FEV1 was to be assessed immediately before bronchodilator administration at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for pre-bronchodilator FEV1. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
1430365|NCT01006616|Secondary|Change From Baseline in Distance Walked in 6 Minutes (6-Minute Walk Test)|The 6-minute walk test measures the distance participants can walk quickly on a flat, hard surface in 6 minutes. The 6-minute walk test was to be conducted at Baseline, Week 26, Week 52 and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for 6-minute walk test. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Meters||Standard Error|Least Squares Mean
1430669|NCT01004393|Secondary|Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
1430366|NCT01006616|Secondary|Change From Baseline in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score|The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms (frequency/severity), Activity (limited by breathlessness), Impacts (social functioning, psychological disturbances), and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. The Total score is calculated by summing the weights to all the positive responses in each component, dividing by the sum of weights for all items in the questionnaire, and multiplying this number by 100. SGRQ-C Total scores could range from 0-100, with a higher SGRQ-C Total score indicating greater disease burden. Participants were to assess their COPD symptoms, activity and impact at Baseline, Week 26, Week 52, and Week 104.|Baseline and Week 26, Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for SGRQ-C score. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Score on a Scale||Standard Error|Least Squares Mean
1430367|NCT01006616|Secondary|Induced Sputum Absolute Neutrophil Counts|Induced sputum samples were to be obtained from participants via the nebulized method for analysis of absolute neutrophil counts at Week 26, Week 52 and Week 104. The reported Baseline least squares (LS) means and standard deviations (SDs) are pooled across all treatment groups. The rationale for the use of pooled Baseline LS mean and SD values is the assumption that the Baseline LS mean and SD values are similar across treatment groups. The reported post-Baseline SDs are pooled across all treatment groups. The rationale for the use of an analysis of variance (ANOVA) method using pooled SD values is the assumption that the SDs are similar across treatment groups.|Baseline, Week 26, Week 52, Week 104|The FAS population consisted of all participants at selected sites who received at least one dose of study drug and had a baseline and Week 26, Week 52 or Week 104 assessment for sputum neutrophil count. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||10^9 cells/L||Standard Deviation|Least Squares Mean
1430368|NCT01006616|Secondary|Total Exacerbations of Chronic Pulmonary Disease Tool-Patient-Recorded Outcome (EXACT-PRO) Questionnaire Score|The total score on the EXACT-PRO questionnaire is used to determine the frequency, severity, and duration of exacerbations of COPD. The 14-item EXACT-PRO questionnaire was to be completed by participants every evening to describe their experience of COPD during that day. Assessments were included for Breathlessness (5 items), Cough and Sputum (2 items), Chest Symptoms (3 items), and 4 additional items (Difficulty with Sputum, Tired or Weak, Sleep Disturbance, and Psychological State). Each item was measured on a 5- or 6-point scale. The total EXACT-PRO questionnaire score could range from 0 to 100, with a higher score indicating a more severe health state.|At 26, 52 and 104 weeks|The FAS population was to consist of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for total EXACT-PRO score. This analysis was not conducted if results for percentage of participants with moderate to severe COPD exacerbation suggested no need for further investigation.||||||
1430369|NCT01006616|Secondary|Percentage of Participants With a Moderate to Severe COPD Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The percentages of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26, 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.|||Percentage of Participants|||Number
1430370|NCT01006616|Secondary|Number of Participants With a Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|COPD exacerbation is defined as any deterioration of symptoms that leads to an increase in bronchodilator use on 2 or more consecutive days, or administration (at investigator's discretion) of antibiotics and/or systemic corticosteroids (above participant's usual dose), or an unscheduled COPD-related doctor visit, hospitalization or emergency room treatment. The numbers of participants who experienced at least one moderate to severe COPD exacerbation during the first 26 weeks, the first 52 weeks and the first 104 weeks of treatment were to be summarized.|Up to 26 , 52 and 104 weeks|The FAS population consisted of all participants who received at least one dose of study drug and had a Week 26, Week 52 or Week 104 assessment for COPD exacerbation. The study was terminated during Period 2; no data were collected for this endpoint for up to 104 weeks.|||Participants|||Number
1430371|NCT01006616|Secondary|Change From Baseline in Post-bronchodilator FEV1 (Period 2)|FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were to be assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline, Week 52 and Week 104.|Baseline and Week 52, Week 104|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline and Week 52 or Week 104 assessment for post-bronchodilator FEV1 in Period 2. The study was terminated during Period 2; no data were collected for this endpoint at Week 104.|||Liters||Standard Error|Least Squares Mean
1430372|NCT01006616|Primary|Percentage of Participants With an Adverse Event (AE) Related to a Blood Absolute Neutrophil Count (ANC) of Less Than 1.5x10^9 Cells/L|The percentage of participants who experienced an AE related to an ANC of less than 1.5x10^9 cells/L at one or more visits during the first 26 weeks, the first 52 weeks and the first 104 weeks was to be calculated.|Up to 104 weeks|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. The study was terminated during Period 2; no data were analyzed for this endpoint for up to 52 and up to 104 weeks.|||Percentage of Participants|||Number
1430527|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour post-dose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430375|NCT01006603|Secondary|Change From Baseline to Week 52 in Insulin|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||µU/mL||95% Confidence Interval|Mean
1430376|NCT01006603|Secondary|Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)|Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||mmol/L||95% Confidence Interval|Mean
1430377|NCT01006603|Secondary|Proportion of Patients Achieving a Therapeutic Glycaemic Response at Week 52 Defined as HbA1c <7.0%|Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits. Full analysis set.|From week 0 to week 52|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||percentage of responders|||Number
1430378|NCT01006603|Secondary|Change From Baseline to Week 52 in HbA1c.|Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.|From week 0 to week 52.|The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).|||% of glycosylated hemoglobin||95% Confidence Interval|Mean
1430379|NCT01006603|Secondary|Proportion of Patients Having Experienced at Least One Hypoglycaemic Event (Confirmed or Severe) Over the 52-week Double-blind Treatment Period.|"Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).|||percentage of patients|||Number
1430380|NCT01006603|Primary|Proportion of Patients Reaching HbA1c <7% After 52 Weeks of Treatment Without Confirmed or Severe Hypoglycaemia.|"Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory. Safety analysis set.~Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).~Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration. These events may be associated with sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration."|From week 0 to week 52.|Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).|||percentage of participants|||Number
1430381|NCT01006590|Secondary|Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta||Baseline and 24 weeks||||Percent (%)||Standard Error|Mean
1430382|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Insulin||Baseline and 24 weeks||||microUnit/milliLiter||Standard Error|Mean
1430383|NCT01006590|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose||Baseline and 24 weeks||||millimol/Liter||Standard Error|Mean
1430384|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent|24 Weeks||||Percentage of patients|||Number
1430385|NCT01006590|Secondary|Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%|Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent|24 Weeks||||Percentage of patients|||Number
1430386|NCT01006590|Primary|Absolute Change From Baseline in HbA1c at Week 24||Baseline and 24 weeks||||Percent (%)||Standard Error|Mean
1430396|NCT01006291|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group|||Episodes/100 years of patient exposure|||Number
1430387|NCT01006356|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) which are based on 4-point scale (1=Not at all to 4=Very much); and global health status and quality of life scale based on 7-point scale (1=very poor to 7=Excellent). All scales and items are averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptomatology or problems.|Day 1 and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a Scale||Standard Deviation|Mean
1430388|NCT01006356|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|Investigators evaluated the overall improvement of the participant’s condition using CGI scale. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s patient’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=greatly improved; 2=somewhat improved; 3=slightly improved; 4=no change; 5=slightly aggravated ; 6=somewhat aggravated; 7=greatly aggarvated.|Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure.|||Participants|||Number
1430389|NCT01006356|Secondary|Participant’s Preferences Along With Reasons|The number of participants who preferred oral long-acting narcotic analgesics or previously administered oral opioid analgesic were reported along with detailed and specific reasons such as consistent analgesic effect during administration, sleep undisturbed by pain, reduced intake of medication frequency, reduce intake of immediate-release opioid analgesic for breakthrough pain treatment, other and no response, for their preferences. Same participant may have multiple reason for their preference.|Day 15|The ITT analysis population included all participants who received at least 1 dose of study drug and had available data in dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'N'=participants evaluated for this outcome measure and 'n'=participants who took hydromorphone OROS/oral opioid.|||Participants|||Number
1430390|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Participant|Participants evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', ‘effective response', ‘very effectiveresponse', and ‘highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."|||Participants|||Number
1430391|NCT01006356|Secondary|Global Assessment of Overall Efficacy of Study Drug by Investigator|Investigator evaluated overall efficacy of study drug and the responses were categorized as: 'ineffective response', 'average response', ‘effective response', ‘very effectiveresponse', and ‘highly effective response'.|Day 15|"The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here N signifies participants evaluated for this outcome measure."|||Participants|||Number
1430392|NCT01006356|Secondary|Pain Intensity Score|Average Pain intensity score experienced by Participant over the last 24 hours of Day 3 and Day 13 was recorded. Pain intensity was measured using numerical rating scale (NRS) ranging from 0=no pain to 10=most severe pain.|Day 3 and Day 13|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used. Here 'n' signifies participants evaluable for this outcome measure at given time point.|||Units on a scale||Standard Deviation|Mean
1430393|NCT01006356|Secondary|Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15|K-BPI is an inventory designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of total 9 items in total, and the ninth item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0 to 10, where 0=no pain, 1 to 4=mild pain, 5 to 6=moderate pain and 7 to 10=severe pain.|Baseline and Day 15|The ITT analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.|||Units on a scale||Standard Deviation|Mean
1430394|NCT01006356|Secondary|Frequency of Experiencing Breakthrough Pain|Frequency of experiencing 3 types of breakthrough pain: Idiopathic pain (pain of unknown cause), incidental pain (pain that arises as a result of activity, such as movement of an arthritic joint, stretching a wound) and end-of-dose failure pain was reported.|Day 1 and Day 15|The ITT analysis population included all the as participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. LOCF was used.|||Pain episodes per day||Standard Deviation|Mean
1430395|NCT01006356|Primary|Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain|Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).|Day 15|The intent-to-treat (ITT) analysis population included all the participants who received at least 1 dose of study drug and had available data in the dosing frequency of short-acting narcotic analgesics for treating breakthrough pain at Day 8. Last observation carried forward (LOCF) was used.|||Percentage of Participants|||Number
1430528|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohort 3 During Cycles 1 and 2||Day 1 and Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.|||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
1430397|NCT01006291|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator. In SAS, subjects contributed to the evaluation 'as treated'.230 subjects in the IDeg Flex group, 226 in the IDeg OD group and 229 in the IGlar OD group|||Episodes/100 years of patient exposure|||Number
1430398|NCT01006291|Secondary|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)|Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast.|Week 26|The FAS included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'. For 28 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1430399|NCT01006291|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF). In FAS, subjects contributed to the evaluation 'as randomised'.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1430400|NCT01006252|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) During Cycle 2||After drug infusion in Cycle 2 (2 samples drawn over the 28-day cycle)|The analysis population included all participants who received at least 2 doses of study drug for whom pharmacokinetic data were available. PK analysis were only performed on Tasisulam per protocol.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1430401|NCT01006252|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) During Cycle 1||After drug infusion in Cycle 1 (5 samples drawn over the 28-day cycle)|The analysis population included all participants who received at least 1 dose of study drug for whom PK data were available. PK analysis were only performed on Tasisulam per protocol.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1430402|NCT01006252|Secondary|Change From Baseline at Cycle 4 Baseline in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation|EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 4, up to 30 days after treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1430403|NCT01006252|Secondary|Change From Baseline at Cycle 3 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation|EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 3, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1430404|NCT01006252|Secondary|Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation|EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe the status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 2, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1430405|NCT01006252|Secondary|Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 4, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1430406|NCT01006252|Secondary|Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 3, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1441652|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
1430407|NCT01006252|Secondary|Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy.|Baseline at Cycle 2, up to 30 days following treatment discontinuation|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1430408|NCT01006252|Secondary|Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score|FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. FACT-M TOI is the sum of FACT-M physical well-being, functional well-being, and melanoma subscales. Scores range from 0 to 120; Higher scores=better quality of life (QoL). FACT-M TOI score deterioration was defined as time from randomization to a minimally important difference in TOI score or death.|Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months|The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement.|||months||95% Confidence Interval|Median
1430409|NCT01006252|Secondary|Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria; PD=20% increase in sum of the longest diameter of target lesions.|First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
1430410|NCT01006252|Secondary|Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR)|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. Analysis was adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group. Due to limited number of responses for either treatment arm, DoR analysis was not performed.|First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis per study report.||||||
1430411|NCT01006252|Secondary|Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR)|Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions.|First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
1430412|NCT01006252|Secondary|Progression Free Survival (PFS)|PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause.|Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||months||95% Confidence Interval|Median
1430413|NCT01006252|Primary|Overall Survival (OS)|OS is duration from enrollment to death; OS censored for participants who were alive at last contact.|Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months|The intent-to-treat (ITT) analysis population included all participants randomized to treatment.|||months||95% Confidence Interval|Median
1430414|NCT01006135|Secondary|Patients With Any Adverse Events||6 months|TS|||Number of participants|||Number
1430415|NCT01006135|Secondary|Compliance of Patients|Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.|6 months|Patients from FAS|||Number of participants|||Number
1430416|NCT01006135|Secondary|Additional Bronchodilator or Inhaled Corticosteroids (ICS)|Pulmonary medication from baseline to visit 3 (6 months)|6 months|Patients from Full Analysis Set (FAS) which includes all patients from the TS who were assessed after administration of Spiriva, i.e. who have evaluable SGRQ measurements at visit 2 or visit 3.|||Number of participants|||Number
1430417|NCT01006135|Primary|Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline|The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline and 6 months|Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)|||Units on a scale||Standard Deviation|Mean
1430447|NCT01005901|Secondary|Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period|"The percentage of days able to perform usual daily activities is defined as the total number of days able to perform usual activities over the 26 week treatment period divided by the total number of days where diary recordings have been made.~Mixed model used baseline ability to perform usual daily activities, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.|||percentage of days||Standard Error|Least Squares Mean
1430418|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState ) Composite Score|CogState had 5 outcome measures that measured the cognitive constructs. GMLT, detection, identification, one card learning and CPAL. GMLT score range: 0 (best) to infinity (worst), detection and identification score range: 2 (best) to 3.3 (worst); One card learning score range: 0 (worse) to 1.57 (best) and CPAL score range: 0 (best) to infinity (worst). The individual score was standardized at each assessment and was then averaged to yield a composite score; total possible score: minus infinity to plus infinity. Positive composite score=improved performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
1430419|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)|CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||errors||Standard Deviation|Mean
1430420|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) One Card Learning|One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root of the proportion of correct responses. Score ranges from 0 (worse) to 1.57 (best). Higher scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||arcsine (square root proportion correct)||Standard Deviation|Mean
1430421|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Identification Speed|Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 msec). Score ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||log10 msec||Standard Deviation|Mean
1430422|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Detection Speed|Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (msec)]. Scores ranges from 2 (best) to 3.3 (worst). Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||log10 msec||Standard Deviation|Mean
1430423|NCT01006122|Secondary|Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)|GMLT: a cognitive test which assessed executive function. Participant was shown a 10 multiplied by 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Score ranges from 0 to infinity. Lower scores meant a better performance.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||errors||Standard Deviation|Mean
1430424|NCT01006122|Other Pre-specified|Number of Participants With Response to Sheehan Suicidality Tracking Scale (STS)|Sheehan-STS is an 8-item clinician/participant administered prospective rating scale and an indicator of trigger assessment that tracks both treatment-emergent suicidal ideation and behaviors). Items 1a, 2-6, 8 scored on 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=very, and 4=extremely). Items 1, 1b, 7, an indicator of trigger assessment (TA) require yes/no response. Items included 1= Ever suffer any accident, 1a= Extent plan/intend to hurt yourself, 1b= Intend to die, 2= Wish dead, 3= Want to harm yourself, 4= Think about suicide, 5= Plan for a suicide, 6= Prepare for suicide (PS) with intent to die (ITD), 7= Injure yourself on purpose, 8= Attempt suicide. Result for item 1 indicates if any of the participant ever suffered any accident, 1b indicates if any of the participant intended to die, 7 indicates if any of the participant injured themselves purposely and trigger assessment indicates if any of the participant evoked trigger assessment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively. Results for a parameter are not reported at certain time points since none of the participants were evaluable for the parameter at those time points.|||participants|||Number
1430670|NCT01004393|Secondary|Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||units on a scale||Standard Deviation|Mean
1430425|NCT01006122|Other Pre-specified|Medical Outcomes Study (MOS) Sleep Scale Score|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1(some questions are reversed so that high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range:0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create 7 scale scores and 2 sleep scale index. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), sleep quantity, snoring, awaken short of breath (ASoB), somnolence, sleep adequacy and optimal sleep; and a 9-item overall sleep problems index(SPI) I and II Subscales range from 0-100 except for sleep quantity (SQ) ranging from0 to 24. Except for sleep quantity, higher scores=greater impairment.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1430426|NCT01006122|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=200 msec, maximum Fridericia’s correction of QT (QTcF) interval of 450 to <480 msec, 480 to <500 msec and >=500 msec. Number of participants who met the criteria for potential clinical concern in ECG findings were reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
1430427|NCT01006122|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Laboratory parameters included hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (protein, blood), and clinical chemistry (glucose). Total number of participants with laboratory abnormalities was reported.|Baseline up to Day 21 of stable dosing phase|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
1430428|NCT01006122|Other Pre-specified|Number of Participants With Vital Signs Data|Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (BP) less than (<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP <50 mmHg, supine and standing heart rate <40 beats per minute (bpm) or >140 bpm. Number of participants who met the criteria for potential clinical concern was reported.|Baseline up to 7-10 days after Day 21 (stable dosing phase)|Safety analysis set consisted of all participants who received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||participants|||Number
1430429|NCT01006122|Secondary|Clinical Global Impression of Improvement (CGI-I) Scale Score|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: “Compared to your subject’s condition at the beginning of treatment, how much has your subject changed?”. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1430430|NCT01006122|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality, social functioning (SF), role emotional (RE) and mental health (MH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Day 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1430431|NCT01006122|Secondary|Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase|Cataplexy is a medical condition in which a person suffers sudden physical collapse though remaining conscious. Cataplexy episodes is number of counts the participant had cataplexy.|Baseline, Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “N” (number of participants analyzed) signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||cataplexy episodes||Standard Deviation|Mean
1430432|NCT01006122|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|BFI is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. There are 3 questions that pertain specifically to level of fatigue and 6 questions regarding general activity level, mood and quality of life, all are answered on an 11-point scale, with “0” being “No fatigue at all” to “10” being “As bad as you can imagine”. The global score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. Higher global scores are associated with more severe fatigue.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1446648|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])||Baseline up to Month 7||||percentage of participants|||Number
1430433|NCT01006122|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase|ESS is a simple, self-administered questionnaire which provides a measurement of the participant's general level of daytime sleepiness. The participant rates the chance that he/she would fall asleep when in 8 different situations (e.g. sitting and reading, talking to someone, etc.) commonly encountered in daily life on a scale of 0 (no daytime sleep) to 3 (maximum daytime sleep). Total score was the sum of 8 situations ranges from 0 to 24 with a higher score indicating greater daytime sleepiness.|Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase|FAS consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here “n” signifies participants who were evaluable at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1430434|NCT01006122|Primary|Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase|MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.|Baseline, Day 21 of stable dosing phase|"Full analysis set (FAS) consisted of all participants who were randomized to a treatment sequence and received at least 1 dose of study drug. Here N(number of participants analyzed) signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm."|||minutes||Standard Deviation|Mean
1430435|NCT01006018|Primary|Insulin Secretion|Not measured as study was prematurely terminated due to unanticipated delays.|baseline, 6 months, 9 months (after a 3 month washout)|||||||
1430436|NCT01005966|Secondary|Change From Baseline in Enamel Fluoride Uptake Potential|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one significant measurement of fluoride uptake. Participants without any major protocol violations in given study treatment period were included in the PP population.|||micrograms (μg)* F/centimeters(cm)^2||Standard Error|Mean
1430437|NCT01005966|Secondary|Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)|SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated.|Baseline to 14 days|PP population: All randomized participants who received at least one dose of the study treatments or provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.|||Percentage SMHR||Standard Error|Mean
1430438|NCT01005966|Primary|Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).|Baseline to 14 days|Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.|||Percentage SMHR||Standard Error|Mean
1430439|NCT01005914|Secondary|Half-life of Pegaspargase||The approximate t½ in adult patients is 5.73 days. The half-life is independent of the dose administered, disease status, renal or hepatic function, age, or gender.|||||||
1430440|NCT01005914|Secondary|Rate of Minimal Residual Disease|Cycle 1A: Days 1 through 14 Cycle 1B: Days 1 through 8, after the first 14 days of cycle 1A|End of cycles 1A and 1B|||||||
1430441|NCT01005914|Secondary|Overall Survival||At least every 6 months until death.|||||||
1430442|NCT01005914|Secondary|Proportion of Patients Who Achieve Complete Response or Partial Response After Courses 1 and 2||An interim analysis of safety is planned after the enrollment of 15 evaluable patients.|||||||
1430443|NCT01005914|Secondary|2-year Progression-free Survival||After completion of 8 cycles|||||||
1430444|NCT01005914|Primary|Grade 3 and 4 Toxicity Associated With the Combination of Peg-Asparaginase and Hyper-CVAD Which Include: Allergic Reactions, Elevated Liver Enzymes, Hyperbilirubinemia, Hyperglycemia, Central Nervous System (CNS) Thrombosis, and Pancreatitis.||The assessment of safety will be based mainly on the frequency of adverse events|||||||
1430445|NCT01005914|Primary|Complete Response Rate After Course 1 of Pegaspargase When Administered in Combination With Hyper-CVAD Regimen|The complete response rate after 1A cycle of a PEG-Asparaginase and hyper-CVAD combination regimen will be estimated, and an exact 95% confidence interval will be computed using a binomial distribution.|After day 4 of treatment|Outcome Measure analysis was not performed due to early termination of the study due to safety concerns||||||
1430446|NCT01005901|Secondary|Mean Daily Total Symptom Score Over the 26 Week Treatment Period|"The daily symptom score was calculated as the sum of the worst of the morning and evening assessments for each symptom (symptoms, cough, wheeze, sputum color/production, and breathlessness). The score can range from 0 to 18 with 0 indicating no symptoms. The higher the score, the worse the symptomatic status. A negative change (lower number) indicates improvement.~Mixed model used baseline symptom variables, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1446649|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)||Baseline up to Month 7||||percentage of participants|||Number
1430448|NCT01005901|Secondary|Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period|"The percentage of days with no daytime symptoms is defined as the total number of days with no daytime symptoms over the 26 week treatment period divided by the total number of days where diary recordings have been made.~Mixed model used baseline daytime symptoms, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.|||percentage of days with no symptoms||Standard Error|Least Squares Mean
1430449|NCT01005901|Secondary|Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period|"The percentage of nights with no nighttime awakenings is defined as the total number of nights with no nighttime awakenings over the 26 week treatment period divided by the total number of night where diary recordings have been made.~Mixed model used baseline nighttime awakenings, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|26 Weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. At 26 weeks, the analysis is based on only patients with a value at both baseline and post-baseline.|||percentage of nights with no awakenings||Standard Error|Least Squares Mean
1430450|NCT01005901|Secondary|Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period|One overall rate is calculated for the entire study population. Rate is the number of moderate or severe exacerbations per year = total number of moderate or severe exacerbations for all participants/total number of treatment years for all participants. COPD exacerbations were considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations were considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.|||exacerbations per year|||Number
1430451|NCT01005901|Secondary|Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|26 Weeks and 30 Day follow-up|The safety set included all patients who received at least one dose of study medication whether or not being randomized. Patients were randomized according to the treatment they received.|||participants|||Number
1430452|NCT01005901|Secondary|Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26|The mean heart rate was collected with a 24 hour Holter monitor in a sub-set of the safety population. The change between baseline and day 1, week 12 and week 26 was calculated. The analysis of the Holter recordings was performed by a central facility. Data on heart rate, heart rate variability, supraventricular and ventricular ectopy were collected and assessed.|Baseline, Day 1, Week 12 and Week 26|"The safety set included all patients who received at least one dose of study medication whether or not being randomized. A sub-set of the safety population had 24 hour Holter monitoring. n indicates patients with observations both at baseline and each endpoint."|||beats per minute||Standard Deviation|Mean
1430453|NCT01005901|Secondary|Trough FEV1 and FVC at Day 1 and Week 26|"Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates.~Trough FVC was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FVC readings. Mixed model used baseline FVC, baseline ICS use, FEV1 prior to inhalation of SABA, and FEV1 45 minutes post-inhalation of SABA as covariates."|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. If one of the 23 h 15 min or 23 h 45 min values are missing then the remaining non-missing value is taken as trough FEV1 or trough FVC. If both values are missing, then their trough FEV1 or trough FVC is regarded as missing|||Liters||Standard Error|Least Squares Mean
1430454|NCT01005901|Secondary|FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 23 h 45 min post dose at week12/week 13and week 26/week 27 where available for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Week 12 and Week 26|Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed.|||Liters||Standard Error|Least Squares Mean
1430455|NCT01005901|Secondary|FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26|The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post dose at Week 1 Day 1, Week 12 and Week 26 for every patient in the serial spirometry subgroup. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1, Week 12 and Week 26|"Serial spirometry group, a sub-set of the full analysis set of patients. Twelve hour serial spirometry was conducted in this subset of patients in selected centers at Day 1. At week 12/13 and week 26/27 a 24 hour serial spirometry was performed. n is the number of patients with non-missing observations at each time point."|||Liters||Standard Error|Least Squares Mean
1430456|NCT01005901|Secondary|Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FVC, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point.|||Liters||Standard Error|Least Squares Mean
1430457|NCT01005901|Secondary|FEV1 at Each Time-point on Day 1 and Week 26|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at all time points up to 4 hours post-dose, and at 23 hours 15 min and 23 hours 45 min, by visit. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|Day 1 and Week 26|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. “n” indicates number of patients with observation at each time-point|||Liters||Standard Error|Least Squares Mean
1430458|NCT01005901|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening. The total number of puffs of rescue medication per day over the full 26 weeks was calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients with observations both at baseline and week 26 were included in this analysis|||Puffs per day||Standard Error|Least Squares Mean
1430459|NCT01005901|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment|The time to the first moderate or severe COPD exacerbation was the study day on which the patient experienced first moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required.|26 weeks|"Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication.~The median values were not estimable."|||Days||95% Confidence Interval|Median
1430460|NCT01005901|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Individual component score was imputed with LOCF (last observation carried forward).|||Units on a scale||Standard Error|Least Squares Mean
1430461|NCT01005901|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. Mixed model used baseline TDI, baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|26 weeks|Full Analysis Set (FAS) included all randomized patients who received at least one dose of study medication. Patients per treatment group with no missing data were included in this analysis.|||Units on a scale||Standard Error|Least Squares Mean
1430462|NCT01005901|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1,baseline inhaled corticosteroid (ICS) use, FEV1 prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates.|12 weeks|Full Analysis Set (FAS) The FAS included all randomized patients who received at least one dose of study medication. Patients in this group were analyzed according to the treatment to which they were randomized. Missing trough FEV1 values at week 12 were imputed using LOCF with pre-dose trough FEV1.|||Liters||Standard Error|Least Squares Mean
1430463|NCT01005888|Secondary|Functional C1INH Serum Levels|"Percent change in functional C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.~Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH)."|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=20 C1INH-nf, N=22 placebo).|||percent of functional C1INH||Standard Deviation|Mean
1430464|NCT01005888|Secondary|Antigenic C1 Inhibitor (C1INH) Serum Levels|Change in antigenic C1INH serum levels from pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12. Pre-infusion samples obtained at Visit 1 of each therapy period (i.e., baseline) were used to determine change at 1 hour post-infusion for all visits.|Pre-infusion to 1 hour post-infusion at Visit 1 and Weeks 4, 8, and 12|Efficacy Dataset subjects with data at both sampling time points (N=19 C1INH-nf, N=22 placebo).|||mg/dL||Standard Deviation|Mean
1430465|NCT01005888|Other Pre-specified|Total Number of Days of Swelling During Each Prophylactic Therapy Period|A day of swelling was defined as a day that a subject reported swelling at any of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity).|12 weeks|Efficacy Dataset.|||days||Standard Deviation|Mean
1430466|NCT01005888|Secondary|Number of Open-label C1INH-nf Infusions Required During Each Prophylactic Therapy Period|The study design allowed for subjects to be treated with open-label C1INH-nf for laryngeal angioedema, if deemed necessary by the investigator, or prior to emergency surgical procedures.|12 weeks|Efficacy Dataset.|||infusions||Standard Deviation|Mean
1430467|NCT01005888|Secondary|Average Duration of HAE Attacks During Each Prophylactic Therapy Period|"The duration of an attack was measured from the first report of swelling at any one of the five locations (abdominal, genitourinary, facial, respiratory [including laryngeal], or extremity) until the first subsequent report of no swelling at all five locations."|12 weeks|Efficacy Dataset.|||days||Standard Deviation|Mean
1430529|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430469|NCT01005888|Secondary|Number of Subject Withdrawals During Each Prophylactic Therapy Period|At the end of each therapy period, each subject was assigned a yes/no drop-out status. A drop-out was defined as a subject who did not have a Week 12 visit record.|12 weeks|The Safety Dataset (N=24) consisted of all randomized subjects who received at least 1 complete or partial infusion of study drug. 24 subjects began Period 1 (12 C1INH-nf, 12 placebo) and received study drug. 22 subjects crossed over to Period 2 (11 placebo, 11 C1INH-nf) and received study drug. Thus, 23 randomized subjects received each therapy.|||participants|||Number
1430470|NCT01005888|Primary|Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period|An HAE attack was defined as the subject-reported indication of swelling at any location following a report of no swelling on the previous day. Analyses include observed attack counts and normalized attack counts (i.e., the number of attacks observed during each therapy period, normalized for the number of days the subject participated in that period).|12 weeks|The Efficacy Dataset (N=22) consisted of all randomized subjects who completed 12 weeks of therapy in Period 1 and received at least one infusion of study drug in Period 2.|||attacks||Standard Deviation|Mean
1430471|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).|the measured ADC at baseline, 4 weeks after baseline and then 10 weeks after baseline. ADC quantifies the motion of water protons from an MRI.|baseline, 4 weeks post baseline, 10 weeks post baseline||||milimeters^2/sec||Standard Deviation|Mean
1430472|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.|The Kep as measures by MRI at baseline, 4 weeks after baseline, and 10 weeks after baseline.|baseline, 4 weeks after baseline and 10 weeks post baseline||||Min^ -1||Standard Deviation|Mean
1430473|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).|The initial mean Ktrans at baseline, 4 weeks and 10 week. K trans is used to describe the uptake of gadolinium contrast in tissue.|baseline, 4 weeks and 10 weeks||||min^ -1||Standard Deviation|Mean
1430474|NCT01005875|Secondary|The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume|mean tumor volume at baseline, 4 weeks and 10 weeks after start of treatment|baseline, 4 weeks and 10 weeks||||centimeters^3||Standard Deviation|Mean
1430475|NCT01005875|Primary|Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma|Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib|between baseline and 3 years||||participants|||Number
1430476|NCT01005745|Secondary|Number of Participants With Objective Response (OR)|OR is defined as the patient being alive at Day 70 and tumor size evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be a complete response or partial response. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Evaluations were made by computed tomography (CT) scan approximately 6 to 8 weeks after the cell infusion, or CT scan approximately 10 weeks after the cell infusion, or by clinical evaluation during the first 70 days.|Average of 10 Months Follow-up|All participants who completed treatment|||participants|||Number
1430477|NCT01005745|Primary|Number of Participants With Tumor Infiltrating Lymphocytes (TIL) Growth|Feasibility was the primary endpoint of this trial, defined as a patient who can grow and expand T-cells: Number of participants with fragments cultured; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture; Number of participants with fragments that reached a final count of 20e6 cells within 5 weeks of culture and were cocultured with autologous or human leukocyte antigen (HLA)-matched tumor cells for interferon(IFN)-γ production; Number of participants with fragments that produced IFN-γ in response to autologous or HLA-matched tumor cells.|192 Days Post Surgical Resection|All participants|||participants|||Number
1430478|NCT01005732|Secondary|Compliance With Wearing Compression Garment|The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.|About 12 months (follow-up visit 5)|All Participants with available and evaluable data.|||hours per day||Standard Deviation|Mean
1430479|NCT01005732|Secondary|Clinical Appearance of Wound|"Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or no difference) that the indicated zone had the better appearance."|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.|||Participants|||Number
1430480|NCT01005732|Secondary|Thickness of Wound|Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3–5 cm.|Approximately 12 months (follow-up visit 5)|All Participants with available and evaluable measurement.|||mm||Standard Deviation|Mean
1430481|NCT01005732|Secondary|Color of Wound|A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L*a*b* color space was described by The Commission Internationale de I’Eclairage (CIE)(L=brightness [100=white,0=black], a=red-green[red=60,green=-60], b=yellow-blue[yellow=60,blue=-60])|Approximately12 months (follow-up visits 5)|All Participants with available and evaluable measurement.|||color space parameter units|Participants|Standard Deviation|Mean
1430671|NCT01004393|Secondary|Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||units on a scale||Standard Deviation|Mean
1430482|NCT01005732|Secondary|Durometer (Hardness) of Wound|"A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in durometer units (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3–5 cm."|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.|||durometer units||Standard Deviation|Mean
1430483|NCT01005732|Primary|Pressure Under Compression Garment|Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ‘‘dose’’ was measured directly. Values reported are averaged over indicated visits.|Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)|All Participants with available and evaluable measurement.|||mm Hg||Standard Deviation|Mean
1430484|NCT01005719|Secondary|Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing|"The earliest time during the first 4 hours after dosing that the median~pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.)"|Treatment dose to event on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Minutes||Full Range|Median
1430485|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1||Treatment dose to 4-hours post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
1430486|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1||Treatment dose to 24-hour post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
1430487|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
1430488|NCT01005719|Secondary|Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1||Treatment dose to 24-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
1430489|NCT01005719|Secondary|Time to Onset of Inhibition of Acid Secretion on Day 1|The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed.|Treatment dose to onset of event on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Minutes||Full Range|Median
1430490|NCT01005719|Secondary|Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7|The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed.|Treatment dose to 2-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Minutes||Full Range|Median
1430491|NCT01005719|Secondary|Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
1430492|NCT01005719|Secondary|Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at~steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
1430493|NCT01005719|Secondary|Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7|"Number of participants maintaining intragastric pH > 4 for at least 12 hrs at~steady-state on Day 7"|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Participants|||Number
1430494|NCT01005719|Secondary|Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7||Treatment dose to 24-hours post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of Time||Full Range|Median
1430495|NCT01005719|Secondary|Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7||Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of time||Full Range|Median
1430496|NCT01005719|Secondary|Median 24-hr Intragastric pH on Day 7|The median intragastric pH values were recorded over a 24-hr period.|Treatment dose to 24-hour post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||pH||Full Range|Median
1430497|NCT01005719|Secondary|Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7||Treatment dose to 4 hours Post-dose on Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||Percentage of time||Full Range|Median
1430498|NCT01005719|Secondary|Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period|The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of study treatment, and did not have missing values.|||Minutes||Full Range|Median
1430499|NCT01005719|Secondary|The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here.|Treatment dose to 4-hr post-dose on Day 1 and Day 7|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||pH||Full Range|Median
1430500|NCT01005719|Secondary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 1|Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.|||pH||Full Range|Median
1430501|NCT01005719|Primary|Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7|Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here.|Treatment dose to 4-hr post-dose on Day 7|Participants who received at least one dose of study treatment, and did not have missing values.|||pH||Full Range|Median
1430502|NCT01005706|Primary|Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection|Number of Participants with Kidney Rejections|12 months||||participants|||Number
1430503|NCT01005680|Other Pre-specified|Survival Without Toxicity (SWT)|SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.|Randomization to date of toxicity or date of death up to 34.6 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycles. Censored participants: PC=22, GC=10.|||months||95% Confidence Interval|Median
1430504|NCT01005680|Other Pre-specified|Disease Control Rate (DCR)|DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.|Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who are not on concurrent systemic chemotherapy.|||percentage of participants|||Number
1430505|NCT01005680|Secondary|Risk/Benefit Ratio|Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.|Randomization to date of death from any cause up to 35.8 months post-randomization|Safety population: all randomized participants who received at least 1 dose of study drug and were analyzed according to actual treatment received in Cycle 1 of 21-day cycle.|||ratio|||Number
1430506|NCT01005680|Secondary|Tumor Response Rate|Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.|Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization|Tumor Response-Qualified Population: all randomized participants who received at least l dose of study drug, who were diagnosed with locally advanced/metastatic non-small cell lung cancer, who had at least 1 baseline and 1 post-baseline tumor measurement, and who were not on concurrent systemic chemotherapy.|||percentage of participants|||Number
1430507|NCT01005680|Secondary|Time to Treatment Failure (TtTF)|TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.|Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=85, GC=91.|||months||95% Confidence Interval|Median
1430508|NCT01005680|Secondary|Duration of Response (DoR)|DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions|Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned and who achieved CR or PR. Censored participants: PC=1, GC=0.|||months||95% Confidence Interval|Median
1430509|NCT01005680|Secondary|Time to Progressive Disease (TtPD)|TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.|Randomization to first date of PD up to 23.7 months post-randomization|Intent-to-Treat: all randomized participants who were analyzed according to the treatment group they were randomly assigned. Censored participants: PC=12, GC=19.|||months||95% Confidence Interval|Median
1430510|NCT01005680|Secondary|Progression Free Survival (PFS)|PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.|Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization|Intent-to-Treat: all randomized participants who are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=8, GC=10.|||months||95% Confidence Interval|Median
1430511|NCT01005680|Primary|Overall Survival (OS)|OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.|Randomization to date of death from any cause up to 35.8 months post-randomization|Intent-to-Treat: all participants and are analyzed according to the treatment group they were randomly assigned. Censored participants: PC=37, GC=39.|||months||95% Confidence Interval|Median
1430512|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP G2677T/A|Serum digoxin concentration by ABCB1 SNP genotypes|Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
1430513|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 SNP C3435T|Serum digoxin concentration by genotypes for the ABCB1 SNP C3435T|Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
1430514|NCT01005602|Secondary|Serum Digoxin Concentration by ABCB1 Single Nucleotide Polymorphism (SNP) C1236T|55 patients in the Digoxin Dosing per Nomogram group consented to the Pharmacogenetic substudy and provided blood samples to perform pharmacogenetic analyses. We compared serum digoxin concentrations by ABCB1 genotype.|Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
1430515|NCT01005602|Secondary|Serum Digoxin Concentration < 1.0 ng/ml||Steady-state (2 - 4 weeks after initiation)||||percentage of participants|||Number
1430516|NCT01005602|Secondary|Mean Serum Digoxin Concentration||Steady-state (2 - 4 weeks after initiation)||||ng/ml||Standard Deviation|Mean
1430517|NCT01005602|Primary|Percent of Patients Achieving a Desired Steady-state Serum Digoxin Concentration Between 0.5 - 0.9ng/ml||Steady-state (2 - 4 weeks after initiation)||||percentage of participants|||Number
1430518|NCT01005576|Secondary|Incidence of Disease Recurrence||2 years||||Participants|||Count of Participants
1430519|NCT01005576|Secondary|Median Time to Platelet Engraftment||100 days|3 participants did not engraft platelets|||days||Full Range|Median
1430520|NCT01005576|Secondary|Median Time to ANC Engraftment||100 days||||days||Full Range|Median
1430521|NCT01005576|Secondary|Development of Graft Versus Host Disease (GVHD)||2 years||||Participants|||Count of Participants
1430522|NCT01005576|Primary|Primary Objective: Event-free Survival at 1 Year.||1 year||||Participants|||Count of Participants
1430523|NCT01005459|Primary|Spinal Analgesic Duration|duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete|1-2 hrs||||minutes||Standard Deviation|Mean
1430524|NCT01005407|Secondary|Percentage of Participants With Local and Systemic Reaction to Injections||within 7 days for post-injection reactions|Safety population: All participants who received at least 1 study injection and had at least 1 post-baseline safety data. NOTE: Only subjects with non-missing injection results in the Safety population are included in this analysis.|||percentage of participants|||Number
1430525|NCT01005407|Primary|Percentage of Subjects Who Have a Seroprotective Immune Response|Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®|at Week 12 and at Week 32|Non-Inferiority per Protocol population:Randomized subjects who received 1 of 3 consistency lots of HEPLISAV or Engerix-B within the study visit windows, had all 3 study injections as randomized and within the study visit windows, no major protocol deviations, and anti-HBs levels obtained within study visit windows at baseline, Week 12, and Week 32|||Percentage of participants|||Number
1430526|NCT01005355|Secondary|Screen for the Development of Circulating Antibodies Against IMC-1121B (Immunogenicity)|Data presented are the number of participants with treatment emergent antibody positive.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.|||participants|||Number
1430531|NCT01005355|Primary|IMC-1121B Pharmacokinetics - Area Under the Concentration (AUC) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430532|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohort 3 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
1430533|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430534|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohort 3 During Cycles 1 and 2||Day 1 to Day 22 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohort 3 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
1430535|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430536|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Steady State Volume of Distribution (Vss) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Vss for Cycle 1. Vss is not calculated for multiple doses, therefore zero participants were analyzed for Cycle 2.|||milliliters/kilogram (mL/kg)||Standard Deviation|Mean
1430537|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t 1/2) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430538|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Half-Life (t1/2) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate t1/2 for Cycles 1 and 2.|||hours||Full Range|Median
1430539|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430540|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Area Under the Concentration (AUC) Versus Time Curve - Cohorts 1 and 2 During Cycles 1 and 2|AUC for Cycle 1 is AUC from time zero to infinity [AUC(0-∞)] and for Cycle 2 is AUC over a dosing interval (AUCτ).|Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate AUC(0-∞) for Cycle 1 and AUCτ for Cycle 2.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
1430541|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 3 to 5|Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.|Cycles 3, 4 and 5 of a 6-week cycle: predose and 1 hour postdose|Zero participants were analyzed due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5.||||||
1430542|NCT01005355|Primary|IMC-1121B Pharmacokinetics: Maximum Serum Concentration (Cmax) - Cohorts 1 and 2 During Cycles 1 and 2||Day 1 to Day 15 of Cycles 1 and 2 of a 6-week cycle|All participants in Cohorts 1 and 2 who received study drug and had sufficient pharmacokinetics data to calculate Cmax for Cycles 1 and 2.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
1430543|NCT01005355|Primary|Number of Participants With Drug-Related Adverse Events|Data presented are the number of participants who experienced adverse events (AE) of any grade, AE of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), serious adverse events (SAE) and AE resulting in death that was considered to be related to IMC-1121B (ramucirumab). A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline to study completion up to 48 weeks|All participants who received at least 1 dose of study drug.|||participants|||Number
1430544|NCT01005329|Secondary|Distant Failure (Two-year Rate Reported)|Distant Failure (DF) was defined as the appearance of distant metastasis. Death was considered a competing risk. DF rates were estimated using the cumulative incidence method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Median
1430545|NCT01005329|Secondary|Pelvic Failure Rate (Two-year Rate Reported)|Pelvic failure (PF) was defined as disease recurrence in the pelvis, including the pelvic or sacral lymph nodes, and required confirmation by histologic or cytologic biopsy of the recurrent lesion. Death was considered a competing risk. PF rates were estimated using the cumulative incidence method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1430546|NCT01005329|Secondary|Disease-free Survival (Two-year Rate Reported)|Failure was defined as pelvic failure (recurrence in the pelvis, which must be confirmed by histologic or cytologic biopsy of the recurrent lesion), distant failure (confirmed by histologic or cytologic biopsy of the recurrent lesion), or death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Disease-free survival rate at two years was estimated using the Kaplan-Meier method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1430672|NCT01004393|Secondary|Time to Laxation After Administration of Subcutaneous Methylnaltrexone||48 hours after the dose of subcutaneous methylnaltrexone||||hours||Standard Error|Mean
1430547|NCT01005329|Secondary|Overall Survival (Two-year Rate Reported)|Failure was defined as death due to any cause. Patients alive at time of analysis were censored at the date of last contact. Survival rate at two years was estimated using the Kaplan-Meier method.|From registration to two years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1430548|NCT01005329|Secondary|Treatment-related Grade 3+ Adverse Events|The highest grade adverse event per patient reported as definitely, probably, or possibly related to study treatment is counted. Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to end of follow-up, up to 43.4 months; analysis occurred after all patients had been on study for at least one year.|Eligible patients who started treatment|||Participants|||Count of Participants
1430549|NCT01005329|Secondary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 1 Year After Treatment Start|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events reported as definitely, probably, or possibly related to study treatment.|From start of treatment to one year|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1430550|NCT01005329|Primary|Percentage of Participants With Treatment-related, Grade 3+, Non-hematologic Adverse Events Occuring Within 90 Days After Treatment Start|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE, assigning Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of treatment to 90 days|Eligible patients who started study treatment|||percentage of participants||90% Confidence Interval|Number
1430551|NCT01005316|Secondary|Time to Acute Rejection|Time (in days) to acute rejection. Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression). Time to acute rejection is time from transplantation to first acute rejection date.|Transplantation to the end of study.|Transplanted Participants|||Days||Full Range|Mean
1430552|NCT01005316|Secondary|Percentage of Participants Experiencing Acute Rejection|Acute rejection is defined as any one of the following types of rejection: acute cellular rejection (International Society for Heart and Lung Transplant (ISHLT)) system for grading rejection grade 2R or greater), acute refractory cellular rejection (acute cellular rejection unresponsive to two sequential courses of corticosteroids), acute antibody mediated rejection (histological evidence of unequivocal acute capillary injury, with complement deposition and margination of macrophages with or without neutrophils), acute mixed rejection (evidence of acute antibody mediated rejection with ISHLT grade 1R or greater), or acute clinical rejection (clinically-based acute rejection, no matter the ISHLT grade, leading to an acute augmentation of immunosuppression).|Transplantation to the end of study.|Transplanted Participants|||percentage of participants|||Number
1430553|NCT01005316|Secondary|Time to New-Onset Diabetes Mellitus|Time (in days) to new-onset diabetes mellitus. New-onset diabetes mellitus is defined as the new onset of insulin dependency or the need for oral hypoglycemic agents lasting more than 30 days post-transplant. Time to new-onset diabetes is time from transplantation until the diagnosis of new-onset diabetes.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants. Note to provide relevant outcome measure perspective -Of the overall number of participants analyzed, the number of new onset diabetes mellitus cases diagnosed within groups were: Cohort A: Non-Sensitized (N=1); Cohort B: Sensitized, Crossmatch Positive (N=2); and Cohort B: Sensitized, Crossmatch Negative (N=7).|||Days||Full Range|Mean
1430554|NCT01005316|Secondary|Time to Post-Transplantation Lymphoproliferative Disorder|Time (in days) post-transplant lymphoproliferative disorder (PTLD). PTLD is defined as histopathological evidence of lymphoid proliferation (nodal or extranodal) fulfilling the criteria of the revised classification of the WHO 2008 (Swerdlow 2008). Time to PTLD is time from transplantation until the diagnosis of PTLD.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants. Note to provide relevant outcome measure perspective- Of the overall number of participants analyzed, the number of diagnosed PTLD cases within groups were: Cohort A: Non-Sensitized (N=1); Cohort B: Sensitized, Crossmatch Positive (N=0); and Cohort B: Sensitized, Crossmatch Negative (N=3).|||Days||Full Range|Mean
1430555|NCT01005316|Secondary|Time to Diagnosis of Chronic Rejection|Time (in days) to the diagnosis of chronic rejection. Chronic rejection is defined as stenosis, irregularity, or ectasia of the epicardial vessels, or severe peripheral pruning of the distal coronary artery tree. Time to diagnosis is time from transplantation until the first diagnosis of chronic rejection.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||Days||Full Range|Mean
1430556|NCT01005316|Secondary|Percentage of Participants Positive for Severe Infection(s)|Severe infections are defined as a clinical illness considered likely infectious in origin that leads to hospitalization.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
1430557|NCT01005316|Secondary|Percentage of Participants With Occurrence of Re-Hospitalization(s)|Hospitalization is defined as any hospitalization lasting greater than 24 hours.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
1430558|NCT01005316|Secondary|Presence of C4d on Endomyocardial Biopsy (EMB)|The biopsy of the heart stained positive for the presence of C4d, a potential marker of rejection.|Transplantation to the end of study (up to 4 years post transplant).|Transplanted Participants|||percentage of participants|||Number
1430563|NCT01005316|Secondary|Time From Participant Listing on Organ Wait-List to Receiving Organ Transplant, Death or De-Listing|Time (in days) from listing on the organ wait-list to receiving an organ transplant, death or de-listing. This measure is calculated as time from listing on the organ wait-list until the earliest time among transplantation, death and de-listing.|Study enrollment to transplantation|Enrolled participants who died, were transplanted or de-listed.|||Days||Full Range|Mean
1430564|NCT01005316|Secondary|Percentage of Participants- Mortality While on Transplantation Wait-List|Death that occurred while on the transplantation wait-list, and thus before receiving a heart transplant.|Pre-transplantation|Participants Enrolled, Not Transplanted|||percentage of participants|||Number
1430565|NCT01005316|Secondary|Percentage of Participants Positive for de Novo Donor-Specific Alloantibody Production in the First Year Post-Transplantation|A de novo donor-specific alloantibody (DSA) is a newly developed alloantibody that is against the donor organ. This measure includes all de novo DSA (≥1000 MFI) regardless of is persistence or timing within the first year post-transplant. Alloantibodies are important mediators of acute and chronic rejection.|Transplantation to first year post transplant (up to 12 months post transplant).|Transplanted Participants|||percentage of participants|||Number
1430566|NCT01005316|Secondary|Time to Production of Post-Transplant de Novo Donor-specific Alloantibodies|Time (in days) from transplant to development of de novo donor-specific alloantibodies (DSA). This measure is calculated as time from transplant until the earliest time of development of any de novo DSA. The DSA is a newly developed alloantibody that is against the donor organ. Alloantibodies are important mediators of acute and chronic rejection.|Transplantation to first year post transplant (up to 12 months post transplant).|Transplanted Participants|||Days||Full Range|Mean
1430567|NCT01005316|Primary|Percentage of Participants Positive for Event of Death, Graft Loss or Rejection With Hemodynamic Compromise at 12 Months Post-Transplantation|"This is a composite outcome of death, graft loss or rejection with hemodynamic compromise.~Rejection was considered to be with hemodynamic compromise if the rejection event had new onset echocardiographically measured from fractional shortening <26% with ≥5% fall from last echocardiogram or the rejection event had new onset of heart failure."|12 months post-transplantation|Transplanted Participants|||percentage of participants|||Number
1430568|NCT01005290|Secondary|Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period|Difference in the Adjusted Mean 24-h Diastolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.|||mm Hg||Standard Deviation|Mean
1430569|NCT01005290|Primary|Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.|Difference in the adjusted mean 24-h systolic pressure results using ABPM (Ambulatory Blood Pressure Monitoring)in the PP population.|Days 7 and 36 of Period 1 and days 49 and 85 of Period 2|The PP set included all randomized subjects who received at least one dose of IMP, had a baseline primary endpoint measurement, had at least one post baseline primary endpoint measurement, and who had no major protocol deviations. The PP set served as the primary analysis set for analysis of the primary endpoint.|||mm Hg||Standard Deviation|Mean
1430570|NCT01005251|Secondary|Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary~(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment||||Percent||Inter-Quartile Range|Median
1430571|NCT01005251|Primary|Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)|"Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary.~(GERD = Gastroesophageal Reflux Disease)"|The 7 days before randomisation (baseline) and during 26-30 days of treatment||||Participants|||Number
1430572|NCT01004991|Primary|Complete Response|Complete Response|13 months||||Participants|||Count of Participants
1430573|NCT01004939|Secondary|Duration From Start of Fondaparinux Therapy to HIT|For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only one participant developed HIT after receiving Fondaparinux; thus, rather than presenting median data, data are presented as the number of days from start of therapy to HIT.|||days|||Number
1430574|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy|The participant with HIT II was pretreated with LMWH; however, the serious adverse event of HIT II was documented after the participant switched to Fondaparinux treatment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430575|NCT01004939|Secondary|Number of Participants With Skin Changes Under Fondaparinux Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430576|NCT01004939|Secondary|Number of Participants With Bleedings Under Fondaparinux Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430577|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under Fondaparinux Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430578|NCT01004939|Secondary|Number of Participants With and Without Complications Under Fondaparinux Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430579|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to HIT||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=8 participants with non-missing data.|||days||Full Range|Median
1430580|NCT01004939|Secondary|Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy|HIT II is characterized as a sudden decrease of thrombocyte count because of allergic response on heparin/platelet factor 4 (PF-4) complexes and is a severe and potentially fatal side effect of heparins. Usually, HIT occurs between Day 5 and Day 14 of exposure to UFH or LMWH.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430581|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy|Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.|||participants|||Number
1430582|NCT01004939|Secondary|Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy|Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. Only participants exhibiting skin changes are included in this analysis.|||participants|||Number
1430583|NCT01004939|Secondary|Duration From Start of UFH/LMWH Therapy to Skin Change|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=27 participants with non-missing data.|||days||Full Range|Median
1430584|NCT01004939|Secondary|Number of Participants With Skin Changes Under UFH/LMWH Therapy|No formal definition for skin change was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430585|NCT01004939|Secondary|Number of Participants With Bleedings Under UFH/LMWH Therapy|No formal definition for bleeding was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430586|NCT01004939|Secondary|Number of Participants With Thromboembolisms Under UFH/LMWH Therapy|Any sign of thromboembolism as indicated by investigator was measured.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430587|NCT01004939|Secondary|Number of Participants With Complications Under UFH/LMWH Therapy|A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator).|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430588|NCT01004939|Secondary|Duration of Hospitalizations Before, During, and After Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=3 participants (before Fondaparinux), n=5 participants (during Fondaparinux), and n=1 participant (after Fondaparinux) with non-missing data.|||days||Full Range|Median
1430589|NCT01004939|Secondary|Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=9 participants with non-missing data.|||days||Full Range|Median
1430590|NCT01004939|Secondary|Number of Participants Hospitalized Because of Thromboembolic Treatment|Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430591|NCT01004939|Primary|Number of Newborns With Abnormalities|No formal definition for abnormalities was predetermined; documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||newborns|Participants||Number
1430592|NCT01004939|Primary|Number of Newborns Who Had a “Healthy” Postnatal Classification|A “healthy” documentation was based on the investigators’ individual assessment.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins.|||newborns|Participants||Number
1430593|NCT01004939|Primary|Mean APGAR Score at 1, 5, and 10 Minutes After Birth|APGAR is a test performed by a doctor, midwife, or nurse at 1 and 5 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5-minute score assesses how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant.|4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=26 (1 min) or n=27 (5 and 10 min) newborns with non-missing data.|||scores on a scale|Participants|Standard Deviation|Mean
1430594|NCT01004939|Primary|Mean Head Circumference of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=27 newborns with non-missing data.|||centimeters|Participants|Standard Deviation|Mean
1430595|NCT01004939|Primary|Mean Height of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=37 newborns with non-missing data.|||centimeters|Participants|Standard Deviation|Mean
1430596|NCT01004939|Primary|Mean Weight of Newborn||4 months (all cases occurred between 2004 and 2010)|Newborns of pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010. A total of 124 newborns were born to 120 women; 4 women bore twins. n=63 newborns with non-missing data.|||grams|Participants|Standard Deviation|Mean
1430597|NCT01004939|Primary|Number of Participants Who Delivered a Single Child Versus Twins||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430598|NCT01004939|Primary|Number of Participants With the Indicated Type of Conception/Fertilization||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430599|NCT01004939|Primary|Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430600|NCT01004939|Primary|Number of Participants With the Indicated Reason for the End of Fondaparinux Administration|It is possible that a participant stopped receiving Fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430601|NCT01004939|Primary|Number of Hours After Birth at Which Fondaparinux Administration Was Restarted||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=86 participants with non-missing data.|||hours||Standard Deviation|Mean
1430602|NCT01004939|Primary|Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=45 participants with non-missing data.|||hours||Standard Deviation|Mean
1430603|NCT01004939|Primary|Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430604|NCT01004939|Primary|Duration of Postnatal Fondaparinux Administration|The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=90 participants with non-missing data.|||days||Full Range|Median
1430605|NCT01004939|Primary|Duration of Prenatal Fondaparinux Administration|The prenatal interval is defined as the interval of time until 3 days before birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=99 participants with non-missing data.|||days||Full Range|Median
1430606|NCT01004939|Primary|Duration of Fondaparinux Administration||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010; n=101 participants with non-missing data.|||days||Full Range|Median
1430607|NCT01004939|Primary|Number of Participants Administered the Indicated Dose of Fondaparinux Per Day||4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430673|NCT01004393|Secondary|Laxation After Administration of Subcutaneous Methylnaltrexone||24 and 48 hours after the dose of subcutaneous methylnaltrexone||||percentage of participants||95% Confidence Interval|Number
1430608|NCT01004939|Primary|Number of Participants With the Indicated Reason for Change to Fondaparinux|It was possible for a participant to have changed to fondaparinux for multiple reasons.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430609|NCT01004939|Primary|Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals|The prenatal interval is defined as the interval of time until 3 days before birth. The perinatal interval is defined as the interval of time from 2 days before birth to one day after birth. The postnatal interval is defined as the interval of time beginning 2 days after birth.|4 months (all cases occurred between 2004 and 2010)|Pregnant women who received prophylaxis because of an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism between the years of 2004 and 2010|||participants|||Number
1430610|NCT01004874|Secondary|Median Progression-free Survival|PFS was defined as time in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat|||months||95% Confidence Interval|Median
1430611|NCT01004874|Secondary|Number of Patients Experiencing a Greater Than or Equal to Grade 4 Hematologic or a Greater Than or Equal to Grade 3 Non-hematologic Toxicity|Number of times a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity was experienced|27 months|Intent to treat|||participants|||Number
1430612|NCT01004874|Secondary|Number of Patients Experiencing a Central Nervous System (CNS) Hemorrhage or a Systemic Hemorrhage|Number of times a CNS hemorrhage or systemic hemorrhage was experienced|27 months|Intent to treat|||participants|||Number
1430613|NCT01004874|Secondary|Median Overall Survival|OS was defined as time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|27 months|Intent to treat|||months||95% Confidence Interval|Median
1430614|NCT01004874|Secondary|One and Two Year Overall Survival|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date.|One year and two years|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1430615|NCT01004874|Primary|6-month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.|6 months|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1430616|NCT01004848|Secondary|Knowledge & Attitudes About Diabetes Risk||6 months|||||||
1430617|NCT01004848|Secondary|Physical Activity (Self-report)||6 months|||||||
1430618|NCT01004848|Secondary|Fiber Intake||Change from Baseline to 6 Months||||grams per day||Standard Deviation|Mean
1430619|NCT01004848|Secondary|Energy Expenditure|percent energy expenditure|Change from Baseline to 6 Months||||percent expenditure/day||Standard Deviation|Mean
1430620|NCT01004848|Secondary|HbA1c||Change from Baseline to 6 Months||||percent change||Standard Deviation|Mean
1430621|NCT01004848|Secondary|Triglycerides||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
1430622|NCT01004848|Secondary|Total Cholesterol||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
1430623|NCT01004848|Secondary|HDL Cholesterol||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
1430624|NCT01004848|Secondary|LDL Cholesterol||Change from Baseline to 6 Months||||mg/dl||Standard Deviation|Mean
1430625|NCT01004848|Secondary|Waist Circumference||Change from Baseline to 6 Months||||inches||Standard Deviation|Mean
1430626|NCT01004848|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months||||mmHg||Standard Deviation|Mean
1430627|NCT01004848|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months||Change from Baseline to 6 Months||||mmHg||Standard Deviation|Mean
1430628|NCT01004848|Secondary|Change in Post-prandial Fingerstick Glucose From Baseline to 6 Months|Change in sugar level as measured from fingerstick after a meal, at 6 Months as compared to Baseline|Change in 6 Months from Baseline||||mg/dL||Standard Deviation|Mean
1430629|NCT01004848|Secondary|Change in Fasting Fingerstick Glucose Measurement From Baseline to 6 Months|Change in sugar level as measured from fingerstick, at 6 Months as compared to Baseline|Change from Baseline to 6 Months||||mg/dL||Standard Deviation|Mean
1430630|NCT01004848|Primary|Change in Weight From Baseline to 6 Months||Change from Baseline to 6 Months||||pounds||Standard Deviation|Mean
1430631|NCT01004822|Secondary|Participants With Reduction in Tumor Vascular Permeability: Blood Flow and Blood Volume as Measured by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI is a non-invasive method that provides a functional assessment of microvasculature. The technique can measure changes in vascular permeability, extracellular, and extravascular and vascular volumes. Based on its ability to detect vascular changes, DCE-MRI has recently been evaluated as a biomarker of drug efficacy in clinical trials of angiogenesis inhibitors. Assessment of DCE-MRI started at the 3.0 mg/kg dose cohort.|Stage 2 predose up to end of study|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.||||||
1430632|NCT01004822|Secondary|Participants WithTumor Response of CA-125 Epithelial Ovarian Cancer (EOC)/ Primary Peritoneal Cancer (PPC)|Participants with epithelial ovarian cancer or primary peritoneal cancer having CA-125 levels greater than 2x the upper limit of normal, 2 weeks prior to starting therapy were evaluated for CA-125 response and response is defined as a 50% decrease in CA-125 from a pre-treatment sample. The response was confirmed and maintained for at least 28 days. CA-125 response was calculated as intervening samples and the 28-day confirmatory sample must be less than or equal to (within assay variability of 10%) the previous sample Progression or recurrence based on serum CA-125 is defined according to the participants baseline levels.|Stage 2 every cycle|Results are not reported for this measure, as, none of the participants could reach out to Stage 2 due to discontinuations of all the participants in Stage 1.||||||
1430633|NCT01004822|Secondary|Objective Response Rate - Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and Progressive Disease.|Every 8 weeks from start of treatment until last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||percentage of participants|||Number
1430634|NCT01004822|Secondary|Number of Anti Drug Antibody Samples With Positive Anti-CVX-241 Antibodies|Results were summarized for overall study population as per planned analysis.|Day 1 pre-dose of each cycle up to last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||samples|||Number
1430635|NCT01004822|Secondary|Change From Baseline in Serum Angiopoietin-2 (Ang2) Concentrations|Angiopoietin-2 (Ang2) and a related protein, angiopoietin-1 (Ang1) are ligands of the endothelial cell receptor Tie-2, a receptor tyrosine kinase, and are known to mediate the angiogenesis process together with VEGF and other angiogenic regulators. Ang1 stimulates the phosporylation of Tie-2, recruits pericytes to newly formed blood vessels, and promotes their maturation. Ang2 competes with Ang1 for binding of Tie-2, promotes the dissociation of pericytes, and results in unstable blood vessels. In the presence of VEGF and other angiogenic factors, endothelial cells in these unstable vessels proliferate and migrate to form new blood vessels.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||pg/mL||Standard Deviation|Mean
1430636|NCT01004822|Secondary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentrations|VEGF family consists of five glycoproteins known as VEGF-A, -B, -C, and -D, and placental growth factor (PlGF), which bind to three structurally similar receptor tyrosine kinases VEGFR1, VEGFR2, and VEGFR3. The different ligands have distinctive binding specificities for each of the receptors. In response to ligand binding, the VEGFRs activate distinct downstream signalling pathways. VEGFR2 is expressed in the vasculature and is the key mediator of VEGF-induced angiogenesis.|Cycle 1/Day 1, Cycle 1/Day 5, Cycle 1/Day 8, Cycle 1/Day 15, Cycle 1/Day 22, Cycle 2/Day 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1430637|NCT01004822|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|Safety analysis set included all randomized participants who received at least one dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||hours||Standard Deviation|Mean
1430638|NCT01004822|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Due to premature termination of the study, only certain exposure-related noncompartmental PK parameters were calculated.|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study, CL data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.||||||
1430639|NCT01004822|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|Due to premature termination of the study Cmin data were not calculated, only certain pre-specified exposure related non compartmental pharmacokinetics (PK) parameters were calculated.||||||
1430640|NCT01004822|Secondary|Maximum Observed Plasma Concentration (Cmax)|Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1, Day 22 of cycle 1|"Safety analysis set included all randomized participants who received at least one dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1430641|NCT01004822|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞)u for unbound drug. It is obtained from AUC (0 - t)u plus AUC (t - ∞)u for unbound drug. Study drug was analysed using serum Angiopoietin-2 (Ang2) and plasma Vascular Endothelial Growth Factor (VEGF).|Pre-dose, 1, 2, 4, 6 hours post dose at Day 1 of cycle 1|"Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here n signifies those participants who were evaluable for this measure at specified time points for each arm, respectively. Data for Stage 2 is not reported due to early termination of the study."|||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1430657|NCT01004614|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)|"AUC last = Area under the concentration versus time curve from zero time until the last measurable concentration is calculated using the trapezoidal rule.~AUCinf = AUClast + (Ct / kel), where Ct is the estimated concentration at the last measurable concentration."|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||ng*h/mL||Standard Deviation|Mean
1430642|NCT01004822|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs and non-SAEs that occurred during the study.|Baseline up to 28 days after last dose of study medication (last dose = up to Cycle 39)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Data for Stage 2 is not reported due to early termination of the study.|||participants|||Number
1430643|NCT01004822|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Week 4|Safety analysis set included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1430644|NCT01004822|Primary|Recommended Phase 2 Dose (RP2D)|RP2D was the highest dose where 0 of 3 or less than (<2) out of 6 participants experience a DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study RP2D could not be assessed.||||||
1430645|NCT01004822|Primary|Maximum Tolerated Dose (MTD)|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).|Stage 1: Baseline up to Day 28 (end of cycle 1)|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Due to premature termination of the study MTD could not be assessed.||||||
1430646|NCT01004770|Primary|Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image|Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase|Pre and post contrast administration|Per Study Protocol|||Hounsfield Units||Standard Deviation|Mean
1430647|NCT01004770|Primary|12-Lead Electrocardiogram (ECG) Values|12-Lead ECG values taken up to and including 24 hours|Baseline and up to and including 24 hours post contrast administration|Per Study Protocol|||QTcB (msec)||Standard Deviation|Mean
1430648|NCT01004770|Primary|Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values|Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.|Baseline and up to and including 8 hours post contrast administration|Per Study Protocol|||> 10 beats per minute (bpm)||Standard Deviation|Mean
1430649|NCT01004770|Primary|Vital Signs (Blood Pressure) Systolic and Diastolic Values|Systolic and Diastolic bolld pressure taken up to and including 8 hours|Baseline and up to and including 8 hours post contrast administation.|Per Study Protocol|||mm Hg||Standard Deviation|Mean
1430650|NCT01004770|Primary|Blood Urea Nitrogen and Creatinine Serum Values|Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.|Baseline and up to and including 72 hours post contrast administration|Per Study Protocol|||mg/dL||Standard Deviation|Mean
1430651|NCT01004705|Secondary|The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population|||mg/dL||Standard Deviation|Mean
1430652|NCT01004705|Primary|The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.|Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.|Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2|Per Protocol population|||mg/dL||Standard Deviation|Mean
1430653|NCT01004614|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||hour||Full Range|Median
1430654|NCT01004614|Secondary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||hour||Standard Deviation|Mean
1430655|NCT01004614|Secondary|Apparent Terminal Elimination Half-Life (T-half)|Terminal phase half-life calculated as ln(2) / kel|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||hour||Standard Deviation|Mean
1430656|NCT01004614|Secondary|Apparent Terminal Elimination Phase Rate Constant (Kel)|Estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||L/h||Standard Deviation|Mean
1430659|NCT01004614|Primary|Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)|Area under the concentration-time curve from zero time until the last sampling time|prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose|The PK parameter analysis set was defined as all subjects randomized and treated who completed the study.|||ng*h/mL||Standard Deviation|Mean
1430660|NCT01004510|Primary|Rate of Control (Lack of Need for Palliative Intervention of Malignant Pleural Effusions) in Patients With Non Small Cell Lung Cancer Treated With Standard Regimens of Cytotoxic Chemotherapy With the Addition of Zometa||3 months|Too few patients enrolled to analyze data||||||
1430661|NCT01004432|Secondary|Change in ESR-based DAS28 Score at Week 76 Relative to Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESR-based DAS28 score range: 0 to 9.4, higher score=more disease activity.|Week 52, 76|Study extension mITT population. Here 'N' (number of participants analyzed) = participants evaluable for this measure and ‘n’ = participants evaluable at specified time point for each arm, respectively. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).|||units on a scale||Standard Deviation|Mean
1430662|NCT01004432|Secondary|Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP)-Based ACR20 Response at Week 76 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, is reported.|Week 76|Study extension mITT population included all participants, who were enrolled into the 24-week study extension period at Week 52, and received at least 1 golimumab SC injection during the study extension period. Participants reported in other groups are subgroups of ‘Study Extension OL Group’ by treatment received in the OL/DB phase (Weeks 16-52).|||percentage of participants||95% Confidence Interval|Number
1430663|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 52 Relative to Week 16|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, is reported.|Week 52|Double-blind modified Intent To Treat (mITT) population included participants who were randomized at Week 16 to SC or IV golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization.|||percentage of participants||95% Confidence Interval|Number
1430664|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based Disease Activity Score (DAS28) Response at Week 16 and Maintained Response Through Week 52|Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, is reported.|Week 52|Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label golimumab 50 mg SC injection during the continued open-label/ double-blind treatment period.|||percentage of participants||95% Confidence Interval|Number
1430665|NCT01004432|Secondary|Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate (ESR)-Based ACR20 Response at Week 2|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant’s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Within 2 weeks of initiating therapy|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1430666|NCT01004432|Primary|Percentage of Participants Achieving Erythrocyte Sedimentation Rate (ESR)-Based American College of Rheumatology [ACR] 20 Response at Week 14|Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant’s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.|Week 14|Modified Intent To Treat (mITT) population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1430682|NCT01004354|Secondary|Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment|"HOMA-IR:~It is calculated multiplying fasting plasma insulin (FPI) by fasting plasma glucose (FPG), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5"|Baseline and 8 weeks||||HOMA-IR score||Standard Deviation|Mean
1430683|NCT01004354|Primary|Change in Weight||Baseline and 8 weeks||||kilograms||Standard Deviation|Mean
1430684|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 14 Days Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 14 days post dose are counted in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
1430685|NCT01004263|Primary|Number of Participants Discontinued From Study Due to AEs Occurring Within 24 Hours Post Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants who discontinued due to an AE occurring within 24 hours post dose are counted in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
1430686|NCT01004263|Secondary|Percentage of Participant's Migraine Attacks With Pain Freedom at 2 Hours Post Dose|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom (PF) was defined as a reduction in severity from a rating of 5, 4, 3 or 2 (mild, moderate or severe pain) before the dose to a rating of 1 (no pain) at 2 hours after dosing. Pain intensity ratings were reported in diaries returned at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. PF at 2 hours was summarized as follows: the percentage of treated attacks with PF at 2 hours was calculated for each patient first, then the mean across all patients was calculated.|2 hours post dose|All participants who were enrolled and reported at least one treated migraine attack with at least one post treatment efficacy evaluation|||percentage of participant's attacks||Standard Deviation|Mean
1430687|NCT01004263|Primary|Number of Participants With AEs Within 14 Days Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. AEs were assessed in a phone contact 14 days after the last dose of study medication. Participants with an AE occurring within 14 days after any dose administered during the study are counted once in this summary.|Up to 14 days post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
1430688|NCT01004263|Primary|Number of Participants With Adverse Events (AEs) Within 24 Hours Post Any Dose|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration. Participants reported AEs in a diary and these were collected by the study site at visits at 1, 2, 3, 4, 6, 9, and 12 months after Screening visit. Participants with an AE occurring within 24 hours after any dose administered during the study are counted once in this summary.|Up to 24 hours post dose|All enrolled participants who administered at least one dose of study medication|||participants|||Number
1430689|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During the Maintenance Therapy Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the start of the maintenance to the first date of objectively determined PD during the maintenance therapy (assessment during maintenance treatment completed at every other cycle till PD and at 30 day follow-up)(Cycle 5 up to 104.1 Weeks)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Percentage of Participants||95% Confidence Interval|Number
1430690|NCT01004250|Secondary|Percentage of Participants With Confirmed Response Complete or Partial Response During the Induction Treatment Only|CR and PR defined per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From the time of study enrollment to the first date of objectively determined PD during the induction therapy (assessment during study treatment completed at every other cycle up to four cycles) (Baseline up to 4 cycles)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Percentage of Participants||95% Confidence Interval|Number
1430691|NCT01004250|Secondary|Percentage of Participants With Confirmed Complete Response or Partial Response During Study Treatment (Induction and Maintenance)|Overall Response Rate (ORR) is defined as the percentage of participants whose best response is complete response (CR) or partial response (PR) per RECIST Guidelines, Version 1.0. CR is disappearance of all tumor lesions. PR is either a) at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LDs, or b) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared.|From enrollment to objectively determined PD (assessment during study treatment completed at every other cycle till PD and at 30 day follow-up)(Baseline up to 104.1 Weeks)|"Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Percentage of Participants||95% Confidence Interval|Number
1430735|NCT01003938|Secondary|CA125 Stable Disease Duration|Stable disease (SD) duration is measured from the tile of start of therapy until the criteria for progression are met. SD: CA125 decreases <50% or increases <100%. Disease progression: CA125 doubles the value of baseline, or more, over time.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
1430692|NCT01004250|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS will be censored at the last contact date.|From enrollment to the date of death from any cause (every cycle during study treatment, every 6 weeks during follow-up period until PD, and then at least every 3 Months) (Baseline up to 36.3 Months)|32 participants were censored. All enrolled participants receiving at least one dose of study drug.|||Months||95% Confidence Interval|Median
1430693|NCT01004250|Primary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the time from the date of study enrollment to the first date of objectively determined PD or death from any cause. PD is defined using Response Evaluation Criteria in Solid Tumours (RECIST) Guidelines (Version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For participants who receive subsequent systemic anticancer therapy, PFS will be censored at the date of the last objective progression-free disease assessment prior to post-discontinuation systemic therapy.|From enrollment to the first date of objectively determined Progressive Disease (PD) or death from any cause (every other cycle during study treatment and then every 6 weeks during follow-up period)(Baseline up to 36.1 Months)|"30 participants were censored. Participants qualified by the following criteria:~Confirmed histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV lung cancer~At least 1 unidimensionally measurable lesion~No concomitant curative anticancer therapy~Treated with at least one dose of study drug"|||Months||90% Confidence Interval|Median
1430694|NCT01004185|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI Score (0-85, sum of scores for each) abdominal pain (0/2.5/5/7.5/10 - no pain/very mild/mild/moderate/severe), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission is Treatment Success.|Week 26|mITT Subjects who took at least one dose of study medication and did not have baseline stool examination positive for C. difficile, bacterial pathogens or ova/parasites.|||percentage of participants|||Number
1430695|NCT01004185|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI Score (0-85, sum of scores for each): abdominal pain (0/5/10 - no pain/ignored/not ignored), rectal bleeding (0/10/20/30 - none, small amount <50% of stools, small amount most stools, large amount >50%), stool consistency (0/5/10 - formed, partially formed, completely formed), # stools/24 hrs. (0/5/10/15 - 0-2/3-5/6-8/>8), nocturnal bowel/any diarrhea causing wakening (0/10 - no/yes), activity level (0/5/10 - no limitation/occ limitation, severe restrictions). Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85. Remission defined as Treatment Success.|Week 26|MITT subjects who took at least one dose of study medication and did not have baseline stool exam positive for C. difficile, bacterial pathogens or ova/parasites.|||percentage of participants|||Number
1430696|NCT01004172|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Off treatment, participants were followed every 3 months for progression and overall survival. Duration of follow-up for this study cohort was up to 3 years.||2018-04-30|04/2018||||
1430697|NCT01004172|Secondary|Site of First Progression|Site of first progression was defined as progressive disease in either CNS or non-CNS sites by radiographic criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Off treatment, participants were followed every 3 months for progression and overall survival. Duration of follow-up for this study cohort approximated up to 3 years.|The analysis dataset is comprised of all enrolled and assessable participants.|||participants|||Number
1430698|NCT01004172|Secondary|CNS Best Response|"CNS best response was defined based on standard criteria. Adding to above CR and PR:~CNS stable disease (SD) is achieving all the following:~< 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline~No progression on non-measurable lesions~No new CNS lesions (defined as any new lesion >/= 6 mm in LD)~Stable or decreasing steroid dose~No new/progressive tumor-related neurologic signs or symptoms~No progression of extra-CNS disease as assessed by RECIST~CNS Progressive Disease (PD) was experiencing any of the following:~->/- 40% increase in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline~Progression on non-measurable lesions~New CNS lesions (defined as any new lesion >/= 6 mm in LD)~Increasing steroid dose~New/progressive tumor-related neurologic signs or symptoms~Progression of extra-CNS disease as assessed by RECIST"|Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.|The analysis dataset is comprised of all enrolled and assessable participants.|||Participants|||Count of Participants
1430699|NCT01004172|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression, second cancer, or death, whichever occurs first. PFS is estimated using Kaplan-Meier methods.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Off treatment, participants were followed every 3 months for progression and overall survival. Duration of follow-up for this study cohort approximated up to 3 years.||2018-04-30|04/2018||||
1430712|NCT01004107|Secondary|Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments|Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months|3, 6, 9, and 12 months from baseline|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of participants|||Number
1430736|NCT01003938|Secondary|CA125 Response Duration|Response duration is measured from the time measurement criteria for CA125 CR/PR at the first met until the first date that recurrent or progressive disease is objectively documented.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
1430700|NCT01004172|Primary|Central Nervous System (CNS) Objective Response Rate|"CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows:~CNS complete response (CR) is achieved if all of the following are satisfied:~Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases~No new CNS lesions (defined as any new lesion >= 6 mm in LD)~Stable or decreasing steroid dose~No new/progressive tumor-related neurologic signs or symptoms~No progression of extra-CNS disease as assessed by RECIST~CNS partial response (PR) is achieved if all of the following are satisfied:~->/= 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline~No progression on non-measurable lesions~No new CNS lesions (defined as any new lesion >/= 6 mm in LD)~Stable or decreasing steroid dose~No new/progressive tumor-related neurologic signs or symptoms~No progression of extra-CNS disease as assessed by RECIST"|Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.|The analysis dataset is comprised of all enrolled and assessable participants.|||percentage of participants||95% Confidence Interval|Number
1430701|NCT01004159|Secondary|Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population||18 months|All treated and eligible patients|||percentage of particitpants||95% Confidence Interval|Number
1430702|NCT01004159|Primary|12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer||12 week|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1430703|NCT01004146|Secondary|Respiratory Rate||one week prior to surgery to post operative day 1|||||||
1430704|NCT01004146|Secondary|Heart Rate||one week prior to surgery to post operative day 1|||||||
1430705|NCT01004146|Secondary|Oxygen Saturation||one week prior to surgery up to one day after|||||||
1430706|NCT01004146|Secondary|Level of Compliance||3 days to 2 weeks after clinic visit on the day of surgery|||||||
1430707|NCT01004146|Primary|Post Operative Incentive Spirometry Volume|After the operation, the patients to be discharged on the same day were approached in the postanesthesia care unit (PACU) and requested to use the spirometer again. The volume (best out of 2 attempts) was recorded together with the same vital signs recorded preoperatively. Patients who were admitted to the hospital were requested to use the spirometer again on postoperative day 1. The largest IS volume (out of 2 attempts) was recorded. The data presented is the mean largest IS volume the day after surgery.|1 week before surgery to the day after||||cc||Standard Deviation|Mean
1430708|NCT01004107|Secondary|Normal Work During Prior Week Evaluation|"Effectiveness was measured by evaluating subject's ability to work normally, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never:~How often were you unable to do your work because of problems with your hand(s) / wrist(s)?~How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)?~How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)?~How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)?~How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.|||units on a scale||Standard Deviation|Mean
1430709|NCT01004107|Secondary|Difficulty Performing Activities During Prior Week, Both Hands|"Effectiveness was measured by evaluating subject's difficulty in performing routine activities, that require both hands, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:~Open a jar~Button a shirt / blouse~Eat with a knife and fork~Carry a grocery bag~Wash dishes~Wash your hair~Tie shoelaces / knots"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set; see previously reported population description. 1 subject did not complete baseline questionnaire; 1 subject did not complete 6-month questionnaire.|||units on a scale||Standard Deviation|Mean
1430710|NCT01004107|Secondary|Difficulty Performing Activities During Prior Week|"Effectiveness was measured by evaluating subject's difficulty in performing routine activities during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:~Turn a knob~Pick up a coin~Hold a glass of water~Turn a key in a lock~Hold a frying pan"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set; see previously reported population description. 1 subject did not complete baseline, right hand questionnaire. 2 subjects did not complete baseline, left hand questionnaire.1 subject did not complete 6-month questionnaire for either hand.|||units on a scale||Standard Deviation|Mean
1430711|NCT01004107|Secondary|Mean Hand Function Rating During Prior Week|"Effectiveness was measured by evaluating subject's hand function during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Questions were as follows and were graded by subject as 1 = very good, 2 = good, 3 = fair, 4 = poor, and 5 = very poor:~Overall, how well did you hand work?~How well did your fingers move?~How well did your wrist move?~How was the strength in your hand?~How was the sensation (feeling) in your hand?"|Baseline and 3, 6, 9, and 12 months post-treatment|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 1 subject did not complete questionnaire at 6 months.|||units on a scale||Standard Deviation|Mean
1430734|NCT01003938|Secondary|Time to Progression|Time to progression is defined as the time from first study drug administration until the first day radiological and /or symptomatic disease progression is documented, or until death in the absence of progression.|Up to 3 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
1430713|NCT01004107|Secondary|Patient Satisfaction Evaluation|Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months|3, 6, 9, and 12 months from baseline|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of participants|||Number
1430714|NCT01004107|Secondary|Physician Satisfaction Evaluation|Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among physicians between baseline and 3, 6, 9 and 12 months, by subject|3, 6, 9, and 12 months from baseline|Safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of physicians|||Number
1430715|NCT01004107|Secondary|"Global Aesthetic Improvement Scale (GAIS) Ratings of at Least Improved Over Study"|Effectiveness was measured by evaluating changes in hand appearance, by subject, between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects using the GAIS completed by three, blinded evaluators|3, 6, 9, and 12 months from baseline|GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.|||percentage of participants|||Number
1430716|NCT01004107|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand|To evaluate the efficacy of Radiesse for hand treatment as measured by Global Aesthetic Improvement Scale (GAIS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators.|3, 6, 9, and 12 months from baseline|GAIS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.|||percentage of hands|Hands||Number
1430717|NCT01004107|Secondary|"Global Aesthetic Improvement Scale (GAIS) Ratings of at Least Improved Among the Original Treatment Group Only"|Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators|3 months from baseline|3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once|||percentage of participants|||Number
1430718|NCT01004107|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only|To evaluate the efficacy of Radiesse Injectable Dermal Filler for hand treatment as measured by a Global Aesthetic Improvement Scale (GAIS), by hand, as completed by three, blinded evaluators.|3 months from baseline|3-month GAIS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled & withdrew prior to treatment.|||percentage of hands|Hands||Number
1430719|NCT01004107|Secondary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3, 6, 9, and 12 months from baseline|3-,6-, 9-, and 12-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. After 3 months, the untreated controls were treated with Radiesse and were followed as per the original treatment group.|||percentage of participants|||Number
1430720|NCT01004107|Secondary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3, 6, 9, and 12 months from baseline|BHVSS: safety analysis set, or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) were followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment.|||percentage of hands|Hands||Number
1430721|NCT01004107|Secondary|Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3, 6, 9, and 12 months from baseline|BHVSS: safety analysis set or subset of subjects exposed to study medication at least once. After 3 months, untreated controls were treated with Radiesse. All subjects (n=98) followed to 9-months post-treatment; only the original treatment group (n=75) was followed to 12-months post-treatment. 2 subjects were enrolled & withdrew prior to treatment.|||units on a scale|Hands|Standard Deviation|Mean
1430722|NCT01004107|Primary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3 months from baseline||||percentage of participants|||Number
1430723|NCT01004107|Primary|≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3 months from baseline|3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once|||percentage of hands|Hands||Number
1430724|NCT01004107|Primary|Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.~Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:~4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;~1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest."|3 months from baseline|3-month BHVSS: safety analysis set, which is the subset of subjects who have been exposed to the study medication at least once. 2 subjects were enrolled & withdrew prior to treatment.|||units on a scale|Hands|Standard Deviation|Mean
1430725|NCT01004003|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants|||months||Inter-Quartile Range|Median
1430726|NCT01004003|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants|||months||Inter-Quartile Range|Median
1430727|NCT01004003|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.~95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, phase II participants only|||percentage of participants||95% Confidence Interval|Number
1430728|NCT01004003|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).|||participants|||Number
1430729|NCT01004003|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (15 July 2014); Up to 1031 days|Treated set, only phase II participants.|||months||Inter-Quartile Range|Median
1430730|NCT01004003|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of dose limiting toxicities (DLTs) was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set which included all patients who received at least one single dose of trial medication, including phase I patients from the dose escalation part that were not replaced for MTD determination.|||mg bid|||Number
1430731|NCT01003990|Primary|Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.|Date of First Dose to 30 days post the last dose; approximately 405 weeks)|All Treated Participants|||Participants|||Count of Participants
1430732|NCT01003938|Secondary|Toxicity Profile|"Number of participants (patients) who experienced AEs.~Dry skin, dry eye, acne, erythema, rash, pruritus, and diarrhea were related erlotinib; dehydration, anemia, leukopenia, nausea, vomiting, platelets, and fatigue were realted to topotcan."|the whole treatment phase and 30 days post-treatment||||participants|||Number
1430733|NCT01003938|Secondary|Overall Survival|estimated total time from the start of the trial|4 years|The study was terminated very early (6 enrolled vs. 30 target accrual). No statistical analysis was performed on patient data.||||||
1430755|NCT01003249|Secondary|Number (and Percentage) of Participants With External Anal Sphincter Muscle Dysfunction Via Patient Symptoms.|The percent of patient in each group who had defecation problem|Baseline and 4 weeks||||Participants|||Count of Participants
1430737|NCT01003938|Primary|CA125 Response Rate With Continuous-infusion Topotecan and Erlotinib|Response was assessed after every treatment cycle. Response rate is defined as number of the patients who experienced complete or partial CA125 response (CR or PR). CR: normalization of the CA125 value, determined by 2 observations not less than 4 weeks apart; PR: CA125 decreases by >50% and is confirmed to be 50% or greater on a subsequent determination at least one month later.|Up to 3 years||||participants|||Number
1430738|NCT01003899|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Baseline till progression or death|||||||
1430739|NCT01003899|Secondary|Time to OR|The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.|Baseline till progression or death|||||||
1430740|NCT01003899|Secondary|Duration of Disease Control (DC)|Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).|Baseline till progression or death|FAS - Full Analysis Set|||weeks||Full Range|Median
1430741|NCT01003899|Secondary|Progression Free Survival (PFS) Time|PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death|Baseline till end of study or death|FAS - Full Analysis Set|||Weeks||95% Confidence Interval|Median
1430742|NCT01003899|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.|Baseline till progression or death|FAS - Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
1430743|NCT01003899|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).|Baseline till progression or death|FAS (Full Analysis Set). The FAS consisted of all treated patients, excluding any patients found not be EGFR mutation negative according to central laboratory testing.|||Percentage of participants||95% Confidence Interval|Number
1430744|NCT01003886|Secondary|Percentage of Participants With Postural Hypotension|Postural or orthostatic hypotension is a medical condition where blood pressure falls rapidly after the body changes position most commonly occurring after standing up after sitting for long periods of time.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.|||Percentage of participants|||Number
1430745|NCT01003886|Secondary|Change From Baseline in Diastolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||mmHg||Standard Deviation|Mean
1430746|NCT01003886|Secondary|Change From Baseline in Systolic BP at Week 4 and Week 12|Values at Week 4 and Week 12 minus value at baseline.|Baseline through Week 12|Safety population included participants who had taken at least 1 dose of the study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||mmHg||Standard Deviation|Mean
1430747|NCT01003886|Secondary|Percent Change From Baseline in the IPSS Quality of Life (QoL) Score at Week 4 and Week 12|The IPSS QoL Score is obtained by assessment of a single QoL question on a 7-point likert scale which was scored on a scale of 0-6 where 0 = best possible score to 6 = worst possible score.|Baseline, Week 4 and Week 12|FAS population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the LOCF. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Units on a scale||Standard Deviation|Mean
1430748|NCT01003886|Secondary|Percent Change From Baseline in the International Prostate Symptom (IPSS) Total Score at Week 4 and Week 12|The IPSS total score is obtained by combining the scores of the responses to 1 through 7 component questions all of which were on a 6 point likert scale. Each question is scored from 0-5 for an IPSS range of 0-35 points where 0 = best possible score to 35 = worst possible score.|Baseline, Week 4 and Week 12|Full analysis set (FAS) population included participants who had taken at least 1 dose of the study medication. Missing post-baseline data was replaced by the last observation carried forward (LOCF). The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time points for each group respectively.|||Units on a scale||Standard Deviation|Mean
1430749|NCT01003886|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship.|Baseline up to Week 13 (7 days after last dose)|Safety population included participants who had taken at least 1 dose of the study medication.|||Participants|||Number
1430750|NCT01003301|Primary|The the Size of the 8 Late-phase Skin Response|Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.|Baseline, 2-6 wks||||percentage decline from NAC-1||Standard Deviation|Mean
1430751|NCT01003288|Secondary|Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay|Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response|7, 14, 21 days post vaccination and long term follow up for 5 years|Only HCW 251 were assessed for HI antibodies at 21 days post vaccination|||participants|||Number
1430752|NCT01003288|Primary|Number of Participants With Local and Systemic Adverse Events|Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.|21 days after vaccination|solicited adverse event forms were collected from the volunteers|||participants|||Number
1430753|NCT01003275|Primary|Glucose Area Under the Curve (AUC)|Glucose AUC during a 2-hour oral glucose tolerance test|8 weeks||||mg*min/dL||Geometric Coefficient of Variation|Geometric Mean
1430754|NCT01003249|Secondary|Efficacy of Baclofen vs. Placebo on Number of Voidings Per Day|The number of voiding per day before and after treatment.|Baseline and 4 weeks||||number of voids||Standard Deviation|Mean
1430833|NCT01002339|Secondary|Blood Pressure|Systolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mmHg||Standard Deviation|Mean
1430756|NCT01003249|Primary|Average Scores on Dysfunctional Voiding as Measured With Quality of Life (QOL) Questionnaire|This was measured using the Urogenital Distress Inventory (UDI-6). The UDI-6 is a symptom inventory specific to lower urinary tract dysfunction and genital prolapse. There are 6 items scored. The score range is from 0-100 Lower scores denotes better outcomes.|Baseline and 4 weeks||||scores on a scale||Standard Deviation|Mean
1430757|NCT01003249|Primary|Average Scores on International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|Diagnosis of dysfunctional bladder is based on symptoms demonstrating no relaxation or over stimulation of external urinary sphincter during voiding. Symptoms will be scored by International Consultation on Incontinence Modular Questionnaire- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). The ICIQ-LUTSqol is a patient-completed questionnaire for evaluating quality of life (QoL) in urinary incontinent patients There are 20 items and the score range is 10-200. Higher scores denotes better outcomes.|Baseline and 4 weeks||||scores on a scale||Standard Deviation|Mean
1430758|NCT01003249|Primary|Number of Participants Exhibiting Abnormal EMG Activity During Voiding|EMG with patch electrodes was completed at the end of this four week period. The number of participants with EMG activity during voiding was collected. EMG activity during the voiding is considered abnormal and is a criteria for voiding dysfunction.Lower numbers denotes better outcomes.|Baseline and 4 weeks||||Participants|||Count of Participants
1430759|NCT01003249|Primary|Urine Flow Rate, as Measured With Uroflometry|Uroflometry with patch electrodes will also be completed at the end of this four week period. Higher flow rate denotes better outcome.|Baseline and 4 weeks||||ml/s||Standard Deviation|Mean
1430760|NCT01003210|Secondary|Side Effects From Study Remedy|"Any other symptoms reported by parents in logbooks. Logbooks were returned by 72/105 participants randomized to the homeopathic ear drops group and 78 of those randomized to standard therapy alone."|15 days|The number of participants analyzed includes only those whose parents returned logbooks.|||participants|||Number
1430761|NCT01003210|Primary|Administration of Antibiotics|Number of participants who filled antibiotic prescription (or called back for promised antibiotic prescription) after being diagnosed with acute otitis media at index visit.|15 days||||participants|||Number
1430762|NCT01003210|Primary|Severity of Symptoms of Otitis Media|Ear Treatment Group - 5 scores. Parent rated severity of otitis media symptoms including fever, earache, irritability, feeding and sleeping. Each symptom rated 0, 4 or 7. Total scores range 0 (least symptoms) to 35 most symptom. ETG-5 scores collected 12-15 days after enrollment|15 days||||units on a scale||Standard Deviation|Mean
1430763|NCT01003184|Secondary|Hypoglycemia Rate Per Year|All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.|Baseline, Week 26|Full analysis set (as randomized).|||events per subject-year||95% Confidence Interval|Number
1430764|NCT01003184|Secondary|Change in Triglycerides From Baseline to Endpoint (Week 26).|Change in triglycerides from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.|||mmol/L||Standard Error|Least Squares Mean
1430765|NCT01003184|Secondary|Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).|Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|The analysis was done for the FAS population (as randomised). The last observation carried forward (LOCF) of post baseline values was used for this analysis.|||mmol/L||Standard Error|Least Squares Mean
1430766|NCT01003184|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26).|Change in total cholesterol from baseline to endpoint (week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).~The last observation carried forward (LOCF) of post baseline values was used for this analysis."|||mmol/L||Standard Error|Least Squares Mean
1430767|NCT01003184|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26.|Change in diastolic blood pressure from baseline to week 26.|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||mmHg||Standard Error|Least Squares Mean
1430768|NCT01003184|Secondary|Changes in Systolic Blood Pressure From Baseline to Week 26|Change in systolic blood pressure from baseline to Week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||mmHg||Standard Error|Least Squares Mean
1430769|NCT01003184|Secondary|Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).|Change in fasting serum glucose from baseline to endpoint (Week 26).|Baseline, Week 26|"The analysis was done for the FAS population (as randomised).~The last observation carried forward (LOCF) of post baseline values was used for this analysis."|||mmol/L||Standard Error|Least Squares Mean
1430770|NCT01003184|Secondary|Percentage of Patients Achieving ≤6.5% at Endpoint|Percentage of patients achieving HbA1c ≤6.5% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.|||Percentage||95% Confidence Interval|Number
1430771|NCT01003184|Secondary|Percentage of Patients Achieving ≤7.0% at Endpoint|Percentage of patients achieving ≤7.0% at endpoint.|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.|||Percentage||95% Confidence Interval|Number
1430772|NCT01003184|Secondary|Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint|Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint|Week 26|The analysis was done for the FAS population (as randomised). Patients with baseline HbA1c ≤7.0% and/or no post-baseline HbA1c measurement were regarded as non-responders.|||Percentage||95% Confidence Interval|Number
1430773|NCT01003184|Secondary|Change in Body Weight From Baseline to Week 26|Change in body weight from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||kilograms||Standard Error|Least Squares Mean
1430774|NCT01003184|Secondary|Change in HbA1c From Baseline to Week 26|Change in HbA1c from baseline to week 26|Baseline, Week 26|The analysis was done for the FAS population (as randomised).|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
1430775|NCT01003184|Secondary|Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)|Baseline, Week 26|The analysis was done for the FAS population (as randomised). For secondary analyses including both final HbA1c concentration and change in weight the last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value.|||Percentage||95% Confidence Interval|Number
1430776|NCT01003184|Primary|Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)|The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.|Baseline, Week 26|The full analysis set (FAS) includes all data from all randomised patients receiving at least one dose of the study drug according to the treatment the patients were assigned.|||Percentage||95% Confidence Interval|Number
1430777|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36||||microns||Standard Error|Mean
1430778|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6||||microns||Standard Error|Mean
1430779|NCT01003106|Secondary|Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.||Month 6- Month 36||||Letters||Standard Error|Mean
1430780|NCT01003106|Secondary|Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab||Baseline to month 6||||Letters||Standard Error|Mean
1430781|NCT01003106|Primary|Incidence and Severity of Ocular and Non-ocular Adverse Events.||36 months||||participants|||Number
1430782|NCT01003080|Secondary|Change in Hemoglobin and Hematocrit.||First three days after surgery.|||||||
1430783|NCT01003080|Primary|Drain Output.|This is a measure of the average drain output collected in the first 24 hours following surgery.|First 24 hours following surgery.||||mL||Standard Deviation|Mean
1430784|NCT01003067|Secondary|Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.|Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.|5 Years||2020-06-30|06/2020||||
1430785|NCT01003067|Primary|Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy|Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.|2 years||||participants|||Number
1430786|NCT01002989|Primary|Mean Watch BP Office Ankle-Brachial Index||once (cross-sectional)||||ratio||Standard Deviation|Mean
1430787|NCT01002989|Primary|Mean Doppler Ankle-Brachial Index||once (cross-sectional)||||ratio||Standard Deviation|Mean
1430788|NCT01002989|Secondary|Agreement Between the Two Methods in Peripheral Artery Disease (PAD) Diagnosis|This outcome measure represents what percentage of the patients diagnosed with PAD using Doppler ABI method (reference method) were diagnosed with PAD using WatchBP Office ABI method. It also represents in what percentage of the patients in whom PAD was excluded with Doppler ABI method (reference method), PAD was excluded using WatchBP Office ABI method as well.|Once (cross-sectional)||||Percentage of participants|||Number
1430789|NCT01002989|Primary|Watch BP Office Minus Doppler Ankle-Brachial Index Difference|The validation process consisted of two parts: (i) measurement validation, which compared Doppler and Watch BP Office ABI values and assessed their association, and (ii) clinical validation, which compared the diagnosis of peripheral artery disease (PAD) by the two methods and assessed the association of Watch BP Office and Doppler ABI values with cardiovascular risk factors.|once (cross-sectional)|Patients with various cardiovascular risk factors attending a hypertension or a diabetes outpatient clinic were invited to participate in the study. Subjects with atrial fibrillation or incompressible ankle arteries (ABI ≥1.4) were excluded.|||ratio||Standard Deviation|Mean
1430790|NCT01002742|Secondary|Change in Patient Reported Outcomes From Enrollment to Day 56||Day 56|No data collected||||||
1430791|NCT01002742|Secondary|Treatment Related Mortality (TRM)||Year 1||||percentage of participants||95% Confidence Interval|Number
1430792|NCT01002742|Secondary|Disease-Free Survival (DFS) Post-Randomization|DFS includes death or progression/relapse of malignancy|Year 1||||percentage of participants||95% Confidence Interval|Number
1430793|NCT01002742|Secondary|Cumulative Incidence of a Severe/Life-threatening/Fatal Infections||Year 1||||percentage of participants||95% Confidence Interval|Number
1430794|NCT01002742|Secondary|Incidence of Cytomegalovirus (CMV) Reactivation||Year 1||||percentage of participants|||Number
1430795|NCT01002742|Secondary|Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma||12 months||||participants|||Number
1430796|NCT01002742|Secondary|Incidence of Systemic Infections|Number of participants that experienced at least one infection.|6 Months||||participants|||Number
1430797|NCT01002742|Secondary|Incidence of Chronic GVHD||12 months post-randomization||||percentage of participants||95% Confidence Interval|Number
1430798|NCT01002742|Secondary|Overall GVHD-free Survival Post-randomization||Months 6 and 12||||percentage of participants||95% Confidence Interval|Number
1430799|NCT01002742|Secondary|Incidence of Topical/Non-absorbable Therapy||Day 56||||participants|||Number
1430800|NCT01002742|Secondary|Cumulative Steroid Dose|The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week’s dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared.|Days 28 and 56||||mg/kg|||Number
1430801|NCT01002742|Secondary|Incidence of Discontinuation of Immune Suppression Without Flare||Day 56, Day 180 and Day 360 post-treatment|No data collected||||||
1430802|NCT01002742|Secondary|Incidence of GVHD Flares Requiring Increased Therapy|Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy.|Day 90||||participants|||Number
1430803|NCT01002742|Secondary|Percentage of Surviving Participants With Complete Response (CR)|CR is defined as a score of 0 for the GVHD grading in all evaluable organs.|Days 14, 28, and 56||||percentage of participants|||Number
1430804|NCT01002742|Primary|GVHD-free Survival|Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure.|Day 56||||participants|||Number
1430805|NCT01002573|Secondary|Number of Afebrile and Febrile Subject at 4 Hours Post-Dose|Number of Afebrile and Febrile Subject at 4 Hours Following Treatment|4 Hours Post-Dose|Some participants data was not included in the analysis due to having too few/insufficient data|||participants|||Number
1430806|NCT01002573|Secondary|Time to Afebrility (in Hours)|Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP.|4 Hour post treatment||||Hours||Standard Deviation|Mean
1430807|NCT01002573|Secondary|Change From Baseline in Temperature After the First Four Hours of Treatment|Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4)|0 to 4 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data|||degree Celsius*Time||Standard Deviation|Mean
1430808|NCT01002573|Secondary|Change in Temperature|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment.|4 hours following treatment|Some participants data was not included in the analysis due to having too few/insufficient data|||Celsius||Standard Deviation|Mean
1430809|NCT01002573|Secondary|Change From Baseline in Temperature After the First 60 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment.|60 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data|||Celsius||Standard Deviation|Mean
1430810|NCT01002573|Secondary|Change From Baseline in Temperature After the First 30 Minutes of Treatment|Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment.|30 minutes following treatment|Some participants data was not included in the analysis due to having too few/insufficient data|||Celsius||Standard Deviation|Mean
1430811|NCT01002573|Primary|Fever Reduction|Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)|0 to 2 hours post-dose|Some participants data was not included in the analysis due to having too few/insufficient data|||degree Celsius*Time||Standard Deviation|Mean
1430812|NCT01002482|Secondary|Incidence of Nosocomial Bacteriemia||Date of discharge from the ICU|||||||
1430813|NCT01002482|Secondary|Intensive Care Unit Length of Stay||Date of discharge from the ICU||||days||Inter-Quartile Range|Median
1430814|NCT01002482|Secondary|Hospital Length of Stay||Date of discharge from the hospital||||days||Inter-Quartile Range|Median
1430815|NCT01002482|Secondary|Severe Hypoglycemia|Number of patients with severe biological hypoglycemia (defined as blood glucose of 40 mg per deciliter or less)regardless of clinical signs|Date of discharge from the ICU||||participants|||Number
1430816|NCT01002482|Secondary|Time Spent in Blood Glucose Target||Day of discharge from the ICU|||||||
1430817|NCT01002482|Secondary|Intensive Care Unit Free Days|Intensive care unit free days was 28-day-ICU-free-days i.e. was calculated by subtracting the actual ICU duration in days from 28 with patients who died at day 28 or before being assigned 0 free-days and those who had a stay in ICU of 28 days or more being also assigned 0 free-days|28 days||||days||Inter-Quartile Range|Median
1430818|NCT01002482|Secondary|All-cause In-hospital Mortality||Day of discharge from the hospital||||participants|||Number
1430819|NCT01002482|Secondary|All-cause Intensive Care Unit Mortality||Date of discharge from the ICU||||participants|||Number
1430820|NCT01002482|Secondary|All-cause 28-day Mortality||Day 28||||participants|||Number
1430821|NCT01002482|Primary|All-cause 90-day Mortality||Day 90||||participants|||Number
1430822|NCT01002456|Secondary|Progress Toward Adherence to Guideline Prescription|either change to a guideline agent or dose increase of a guideline agent|6 months||||patients|||Number
1430823|NCT01002456|Primary|Rate of Adherence to Guideline Prescription|full adherence to guideline medication and dose|6 months||||patients|||Number
1430824|NCT01002339|Secondary|Percentage of Patients Using Acetylsalicylic Acid (ASA)||1 year|Analysis population description: participants living with a functioning graft at study end.|||percentage of participants||95% Confidence Interval|Number
1430825|NCT01002339|Secondary|Changes of Carotid Intima-media Thickness Over Time|absolute difference between carotid intima-media thickness at study end versus baseline.|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mm||95% Confidence Interval|Mean
1430826|NCT01002339|Secondary|Percentage of Patients Using Statins||1 year|Participants analyzed: participants living with a functioning graft at study end.|||percentage of participants||95% Confidence Interval|Number
1430827|NCT01002339|Secondary|Lipidic Profile (LDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
1430828|NCT01002339|Secondary|Lipidic Profile (HDL-c)||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
1430829|NCT01002339|Secondary|Lipidic Profile (Cholesterol)|Lipidic Profile (total cholesterol)|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
1430830|NCT01002339|Secondary|Lipidic Profile (Triglycerides)||1 year|Participants analyzed: participants living with a functioning graft at study end.|||mg/dl||Standard Deviation|Mean
1430831|NCT01002339|Secondary|Number of Antihypertensive Drugs Patients Reported Taking.||1 year|Participants analyzed: participants living with a functioning graft at study end.|||number of antihypertensive drugs||Inter-Quartile Range|Median
1430832|NCT01002339|Secondary|Blood Pressure|Diastolic pressure (mmHg)|1 year|Participants analyzed: participants living with a functioning graft at study end.|||mmHg||Standard Deviation|Mean
1430837|NCT01002339|Primary|Primary Outcome Measure (Glucose Intolerance)|Glycemia >=140 and <200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.|1 year|Participants included are those that did not develop NODAT based on not reporting the use of anti-diabetic drugs plus a fasting plasma glucose <126 mg/dl .|||percentage of participants||95% Confidence Interval|Number
1430838|NCT01002339|Primary|Patients Treated With Insulin or Oral Antidiabetic Drugs||1 year|Participant analyzed: participants living with a functioning graft at study end.|||percentage of participants||95% Confidence Interval|Number
1430839|NCT01002339|Primary|"Primary Outcome Measure New Onset Diabetes After Renal Transplantation (NODAT)"|American Diabetes Association criteria (ADA) including an oral glucose tolerance test.|1 year|Participants analyzed: participants living with a functioning graft at study end|||percentage of participants||95% Confidence Interval|Number
1430840|NCT01002287|Secondary|Mobilization Time|The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.|average 10-12 weeks post surgery|All 11 patients meet the per protocol population defined in the protocol and the statistical analysis plan.|||minutes||Standard Deviation|Mean
1430841|NCT01002287|Secondary|Adhesion Involvement Along the Midline Incision (Percentage)|The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.|average 10-12 weeks post surgery|These patients must have values for length of the incision associated with adhesions (cm) and for length of initial midline incision (cm) in order to calculate Extent of Adhesion Involvement (%). NOTE: Extent of Adhesion Involvement (%) = length of the incision associated with adhesions (cm) / length of initial midline incision (cm) * 100.|||percentage of midline incision||Standard Deviation|Mean
1430842|NCT01002287|Secondary|Severity of Adhesions|Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are “1”, “2”, and “3”. Subjects without adhesions were assigned a severity rating of “0”.|Average 10-12 weeks post surgery|All 11 subjects met the definition of per protocol population in the protocol and statistical analysis plan.|||units on a scale||Standard Deviation|Mean
1430843|NCT01002287|Primary|The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.||10-12 Weeks post Initial Surgery for J-Pouch|All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.|||percentage of subjects with adhesions|||Number
1430844|NCT01002118|Secondary|Medication Adherence|percent of pills taken each month calculated as number of pills taken/number of pills dispensed|4 months||||percentage of pills|||Number
1430845|NCT01002118|Secondary|Assess the Effectiveness of Omega-3 Fatty Acid Compared to Placebo on Electrocardiographic Parameters.|percent of subjects with significant arrhythmia present on Holter electrocardiography|4 months||||percentage of Holter montiors obtained|||Number
1430846|NCT01002118|Primary|Determine Recruitment Rates|Determine recruitment by number eligible/number enrolled|4 months||||Participants|||Count of Participants
1430847|NCT01002105|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report form composed of 16 items, each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction with: physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; and living/housing situation. A total score of 1 to 15 items was computed while item 16 assessing overall life satisfaction was not included to avoid exaggerated scores. The total score was averaged from items 1 to 15 and ranged from 1 to 5, with higher scores indicating higher satisfaction."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
1430848|NCT01002105|Secondary|Multidimensional Scale of Perceived Social Support|The MSPSS is a self-report instrument for assessment of emotional help and the level of satisfaction with the social support obtained from three sources - family, friends and significant others. The scale includes 12 items, each of which refer to the people to whom the respondent would turn if he/she had problems of a personal, health or family nature, as well as financial and employment problems. Responses are scored on a 7-point scale from 1 ('completely disagree') to 7 ('completely agree'). The MSPSS index and three subscales – family, friends and significant others - are computed. MSPSS total score ranged from 12 to 84, with a higher score indicating greater satisfaction with total support. Subscores ranged from 4 to 28, with higher score indicating greater satisfaction.|Baseline, 52 weeks||||units on a scale||Standard Deviation|Mean
1430849|NCT01002105|Secondary|General Self-Efficacy Scale|"The GSES measures one’s belief in his/her ability to cope with stressful situations. The scale consists of 10 items (e.g. Usually I am able to control a situation or In unexpected situations, I always know how I must behave myself). Responses are rated on a 4- point Likert-scale ranging from ”absolutely not true” (weighted as 1) to “absolutely true” (weighted as 4), where the higher GSES total scores indicate stronger self-efficacy beliefs.All responses are added to a sum score. The range is from 10 to 40 points with a higher score indicating more self-efficiency."|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
1430850|NCT01002105|Secondary|General Health Questionnaire|The General Health Questionnaire measures whether the respondent has recently experienced a particular symptom or behavior and ranges from 0-much less than usual to 3-much more than usual. Total scores range from 0 to 36 and vary by study population: total scores of about 11-12 are typical, and a score higher than 20 suggests severe problems and psychological distress.|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
1430907|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 1-unit Decrease From Baseline in TDI Focal Score at Week 24 on Treatment|Number of patients achieving a clinically meaningful improvement (≥1-unit) in Transition Dyspnoea Index (TDI) focal score at Week 24 on Treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Percentage of participants|||Number
1430851|NCT01002105|Secondary|Obsessive-Compulsive Drinking Scale Scores|Used to evaluate self-reported alcohol craving. 14 items that provided a total (OCDS) as well as two subscale scores - obsessive drinking (OD) and compulsive drinking (CD). Each of the 14 items are scored from 0 to 4 with the inclusion of 4 split items with only the higher of the two scored items to be used in the total or subscale scores. The OCDS total score ranges from 0-40; the subscales both range from 0 to 20. On all scales, higher scores represent a worse outcome. Data for CD at 6 weeks not available to report|baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks||||units on a scale||Standard Deviation|Mean
1430852|NCT01002105|Primary|Percent Abstinent Days|Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.|one year||||percentage of abstinent days|||Number
1430853|NCT01001988|Primary|Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV|Geometric mean titers of Japanese encephalitis virus antibodies were assessed using the PRNT50 test.|Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
1430854|NCT01001988|Primary|Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV|Seroprotection was defined as the proportion of participants with Japanese encephalitis virus neutralizing antibody titers ≥10 1/dil as measured by a JE 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination|Seroprotection was analyzed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1430855|NCT01001975|Primary|Determination of Ultraviolet A Protection Factor (PFA)|Test materials (V53-028 and V53-030) were applied to test area. Following a series of Ultraviolet radiation A (UVA) exposures, scores were recorded at 2 and 4 hours post-exposure, to determine the Minimal Persistent Pigment-Darkening Dose (MPPD) of protected and unprotected skin. PFA was calculated as the MPPD of protected skin divided by the MPPD of unprotected skin. Expected PFA is a score on a scale; range 6.40 (worst) to 15.62 (best).|2 to 4 hours post-exposure|Only subjects from the UVA Protection Testing group had V53-028 and V53-030 applied for the determination of PFA|||Score on a scale||Standard Deviation|Mean
1430856|NCT01001975|Primary|Determination of Sunscreen Protection Factor (SPF)|Test material (V53-028 and V53-030) and control test material (8% Homoslate SPF 4) were applied to test area. Following exposure to a series of Ultraviolet light exposures, SPF scores were recorded at 16 to 24 hours post-exposure, to determine the Minimal Erythema Dose (MED) of protected and unprotected skin. SPF was calculated as the MED of protected skin divided by the MED of unprotected skin. Expected SPF 15 is a score on a scale; range 11.34 (worst) to 19.83 (best).|16 to 24 hours post-exposure|Only subjects from the SPF Testing group had V53-028 and V53-030 applied for the determination of SPF|||Score on a scale||Standard Deviation|Mean
1430857|NCT01001832|Secondary|Long-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430858|NCT01001832|Primary|Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Participants treated with at least 1 dose of study drug and who had both baseline and post-baseline measurements were analyzed.|||units on a scale||95% Confidence Interval|Mean
1430859|NCT01001832|Primary|Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period|The Health Assessment Questionnaire (HAQ) disability index assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The higher the number the worse the outcome. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. HAQ response=reduction of at least 0.30 units in HAQ score from baseline. The percentage of participants with a reduction of at least 0.30 units in their HAQ score from baseline is presented. Baseline is Day 1 of the study or last non-missing pre-treatment value. Treatment groups represent treatment received in the short term period.|Day 533|N=number of participants treated with at least 1 dose of study drug and with HAQ data available. n=number of participants with HAQ response. n/N = 41/52 and 31/51 in SC and IV arms, respectively. Treatment groups represent treatment received in the short term period.|||percentage of participants||95% Confidence Interval|Number
1430908|NCT01001494|Secondary|Change From Baseline in Peak Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Liters||Standard Error|Least Squares Mean
1430992|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L/hr||Standard Deviation|Mean
1430860|NCT01001832|Primary|Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. Treatment groups represent treatment received in the short term period. Baseline is Day 1 of the study or last non-missing pre-treatment value.|Baseline to Day 533|Number of participants with both baseline and post-baseline measurements in HAQ-DI. Treatment groups represent treatment received in the short term period.|||units on a scale||95% Confidence Interval|Mean
1430861|NCT01001832|Primary|Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period|The ACR score indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score= a percentage. To qualify for a score of 20, 50 or 70 (ACR20, ACR50 or ACR70), the patient must have >=20%, >=50% or >=70%, respectively, fewer tender joints and >=20%, >=50% or >=70%, respectively, fewer swollen joints and show 20%, 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Treatment groups represent treatment received in the short term period. Percentage calculated as n/m with n=number of paticipants with sustained ACR response at Day 533; m= long term participants who received at least one dose of drug and were ACR responders in the short term period.|Day 533|m=Long term period participants who received at least one dose of drug and were ACR responders in short term period: ACR20= 49, 46; ACR50= 35, 34; ACR70= 20, 16. n=number of paticipants with sustained ACR response at Day 533. n/m = percentage|||percentage of participants||95% Confidence Interval|Number
1430862|NCT01001832|Secondary|Long-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; GGT (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430863|NCT01001832|Secondary|Short-term Period: Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN, or if preRX>ULN, use 1.05*preRX or <LLN; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; chloride (mEq/L): <0.75*LLN or >1.125*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; calcium (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.75*preRX or >ULN, or if preRX>ULN, use 1.25*preRX or <LLN; phosphorus (mg/dL): <0.75*LLN or >1.25*ULN, or if preRX<LLN, use <0.67*preRX or >ULN, or if preRX>ULN, use 1.33*preRX or <LLN.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430864|NCT01001832|Secondary|Short-term Period: Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality|ULN=upper limit of normal; LLN=lower limit of normal; preRX=pretreatment. alkaline phosphatase (ALP) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; aspartate aminotransferase (AST) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; alanine aminotransferase(ALT) (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; Gamma glutamyltransferase(GGT) (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430865|NCT01001832|Secondary|Long-term Period: Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 533|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430866|NCT01001832|Secondary|Short-term Period: Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality|lower limit of normal(LLN); upper limit of normal(ULN); pretreatment(preRX). Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430909|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment||Baseline and Week 12|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Liters||Standard Error|Least Squares Mean
1430996|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours (hr)||Full Range|Median
1430867|NCT01001832|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 533 and up to 56 days following last dose in Long-Term period|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430868|NCT01001832|Secondary|Short-term Period: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=related or missing relationship to study medication.|Baseline to Day 169|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1430869|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 533 in Long Term Period|EULAR defines LDAS as DAS28-CRP≤3.2 and defines REM as DAS28-CRP<2.6.|Day 533|m=All treated participants in the long term period in the analysis with available LDAS and REM data. n=number of participants with either EULAR-defined LDAS response or EULAR-defined REM response. n/m = percentage of participants|||percentage of participants||95% Confidence Interval|Number
1430870|NCT01001832|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR)-Defined Low Disease Activity Score (LDAS) and EULAR-defined Remission (REM) at Day 169 in Short Term Period|EULAR defines LDAS as DAS28-CRP less than, equal to (≤) 3.2 and defines REM as DAS28-CRP less than (<) 2.6.|Day 169|m=All randomized participants who received at least 1 dose of study medication and with LDAS and REM data available. n= number of participants with LDAS and REM. n/m=percentage of participants.|||Percentage of participants||95% Confidence Interval|Number
1430871|NCT01001832|Secondary|Mean Change From Baseline at Six Months in DAS28-CRP - All Treated Participants|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient’s global assessment of health (ranging from very good to very bad). An overall DAS >5.1 implies active disease; <3.2, well controlled disease; and <2.6, remission.). Baseline is Day 1 or last non-missing pre-treatment value.|Baseline to 6 Months|All participants who received at least 1 dose of study medication with both baseline and post-baseline measurements were analyzed.|||Units on a scale||95% Confidence Interval|Mean
1430872|NCT01001832|Secondary|Percentage of Participants With HAQ Response at Day 169 in the Short Term Period|The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3. The HAQ-DI response is defined as a reduction of at least 0.30 units in HAQ score from baseline.|Day 169|N=All randomized participants who received at least 1 dose of study medication in short term period. n=number of participants with HAQ response in short term period; n/N=percentage of participants: 41/59 and 30/59|||Percentage of participants||95% Confidence Interval|Number
1430873|NCT01001832|Secondary|Mean Change From Baseline in HAQ-DI Score at Day 169 in Short Term Period|Adjusted mean. The Health Assessment Questionnaire Disability Index (HAQ-DI) assesses patients' functional ability by rating their abilities over the previous week. At least 2 questions are asked from each of 8 categories: dressing and grooming, hygiene, arising, reach, eating, grip, walking, and common daily activities. Patients rate difficulty performing specific tasks: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The sum of the categories score (the highest scored item in the category) is divided by the number of categories answered, yielding a score from 0-3.|Baseline to Day 169|All participants who received at least 1 dose of study medication were analyzed.|||Units on a scale||95% Confidence Interval|Mean
1430874|NCT01001832|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) and American College of Rheumatology 70 (ACR70) Responses at Day 169 in Short Term Period|The American College of Rheumatology (ACR) scores of 50 and 70 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines. The ACR score represents a percentage. To qualify for an ACR50 or ACR70 scores, the patient must have >=50% or >=70%, respectively, fewer tender joints and >=50% or >=70%, respectively, fewer swollen joints and show 50% or 70%, respectively, improvement in at least 3 of the following: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation).|Day 169|m= All participants who received at least 1 dose of study medication in short term period and had data available. n= participants with ACR50 or ACR70 response in the short term period. n/m= percentage|||Percentage of participants||95% Confidence Interval|Number
1430910|NCT01001494|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment||Baseline and Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Liters||Standard Error|Least Squares Mean
1430993|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||hours||Standard Deviation|Mean
1430875|NCT01001832|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period|The ACR score of 20 indicates the degree of improvement in a patient's rheumatoid arthritis (RA), based on ACR guidelines (ACR20). The ACR score represents a percentage. To qualify for an ACR20 score, the patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein test (to assess inflammation). Percentage is calculated n/N with n=number of participants with ACR score of 20 and N= all randomized participants who received at least one dose of study drug.|Day 169|N= All randomized participants who received at least 1 dose of study medication and were analyzed. n=number of participants with ACR20 response at Day 169: 54, 49, respectively. n/N= percentage: 54/59; 49/59.|||Percentage of participants||95% Confidence Interval|Number
1430876|NCT01001806|Primary|Peak Aqueous Penetration||day 4 of treatment|Protocol specified enrollment of 126 subjects and analysis was performed per protocol.|||ng/ml||Standard Deviation|Mean
1430877|NCT01001767|Primary|Change in Flow Mediated Dilation (FMD) of the Brachial Artery|Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia.|baseline and week 24|Randomized to have equal number in both groups|||percent change||Standard Deviation|Mean
1430878|NCT01001702|Secondary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.|Baseline, Up to 72 months|All participants with available assessment.|||Participants|||Number
1430879|NCT01001702|Secondary|Number of Participants Showing Significant Weight Gain or Loss|Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.|||Participants|||Number
1430880|NCT01001702|Secondary|Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations|"A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.~Clinically significant ECGs were defined as:~Sinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.~Supraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.~Symmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett’s formula), QTcF (QT interval corrected Fridericia’s formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline."|Baseline, Up to 72 months|Participants with at least one post-baseline numeric result for the given parameter.|||Participants|||Number
1430881|NCT01001702|Secondary|Number of Participants With Clinically Significant Blood Pressure|"Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.~Systolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.~A diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline."|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.|||Participants|||Number
1430882|NCT01001702|Secondary|Number of Participants With Clinically Significant Heart Rate|Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.|Baseline, Up to 72 months|Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.|||Participants|||Number
1430883|NCT01001702|Secondary|Number of Participants With Clinical Significant Laboratory Tests|"Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.~Clinically significant values are defined as the following:~Bilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase > 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years [Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)].~Eosinophils ≥ 10 %. Hematocrit < 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.~Hemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin > 1 times the upper limit of normal [Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)]."|Baseline, Up to 72 Months|Participants with at least one post-baseline numeric result for the given laboratory test are included in the analysis.|||Participants|||Number
1430884|NCT01001702|Secondary|Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score|"The rater or investigator answered the following question:~Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement"|Baseline, Last Visit (Up to 72 Months)|Participants with baseline assessment and at least one post-baseline measurement for analysis.|||Score on a scale||Standard Deviation|Mean
1430924|NCT01001429|Primary|Intraoperative Hemodynamic Stability|systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm|Intraoperative up to 120 min||||mm/Hg||Inter-Quartile Range|Mean
1430885|NCT01001702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths|"An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.~An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.~Additional information about Adverse Events can be found in the Adverse Event section."|Up to 72 months|Safety population included all participants who received at least one dose of study drug.|||Participants|||Number
1430886|NCT01001572|Secondary|Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
1430887|NCT01001572|Secondary|Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint|The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.|Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
1430888|NCT01001572|Secondary|Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint|The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement.|||Percentage of Participants|||Number
1430889|NCT01001572|Secondary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.|||mmHg||Standard Error|Least Squares Mean
1430890|NCT01001572|Primary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint|Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.|Baseline and Week 8|Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.|||mmHg||Standard Error|Least Squares Mean
1430891|NCT01001559|Secondary|Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications||60 days||||Alterations in antidepressant therapy|||Number
1430892|NCT01001559|Secondary|Number of Hospitalizations Due to MDD|Number of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts|60 days||||Hospitalizations due to MDD|||Number
1430893|NCT01001559|Secondary|Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient’s illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.~Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence."|60 days|All participants|||Days||Inter-Quartile Range|Median
1430894|NCT01001559|Primary|Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline|"The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient’s illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.~Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline."|60 days|All participants|||Participants|||Number
1430895|NCT01001546|Primary|The Impact of an Internet Intervention on Rates of Abstinence From Cigarettes (Self-reported 7-day Point Prevalent Abstinence)||3 months post treatment||||percentage of participants|||Number
1430925|NCT01001429|Secondary|"Time to Achieve Street Fitness"|Subjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.|for 2 hours post-operatively in Post Anesthesia Care unit|Subjects meet criteria for discharge based upon the assessment from a professional independent of the study|||minutes||Inter-Quartile Range|Mean
1432400|NCT00992992|Secondary|Overall Survival|Overall survival is defined as the time from the start of treatment to the date of death from any cause.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Months||95% Confidence Interval|Median
1430896|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Ventromedial Prefrontal Cortex; vmPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
1430897|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Posterior Cingulate Cortex; PCC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
1430898|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Dorsal Cingulate/Medial Prefrontal Cortex; MF/CG)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
1430899|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Left Dorsolateral Prefrontal Cortex; Left DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|See previous sections.|||BOLD signal||Standard Error|Mean
1430900|NCT01001520|Secondary|Subjective Symptoms: Withdrawal Symptoms|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales. The MNWS-N (right now/at the moment) was assessed during each fMRI scanning session visit (Day 8).~To assess if tolcapone (vs. placebo) affect withdrawal symptoms, we statistically analyzed the average of the total MNWS scores across, all 20 subjects, for each study medication period. Specifically, we analyzed for significant differences between reported withdrawal symptoms while taking tolcapone vs. taking placebo."|Day 8 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||units on a scale||Standard Deviation|Mean
1430926|NCT01001429|Primary|Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)|Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.|Intraoperative up to 120 min||||units on a scale||Inter-Quartile Range|Mean
1430994|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||ng*hr/ml||Standard Deviation|Mean
1432483|NCT00992446|Secondary|Median Time to Disease Progression|(Not enough follow-up to report. 6/17/2018 is when this outcome measure will be met)|3 Years Post-Transplant|||||||
1430901|NCT01001520|Secondary|Subjective Symptoms: Cigarette Craving|"Subjective symptoms were assessed during each in-person session throughout each study medication period. During each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). Specifically, subjects completed the QSU-B at day 5, day 8 (fMRI scanning session 1), day 26 (day 5 of study medication period 2), and day 29 (day 8 of study medication period 2; fMRI scanning session 2).~The range of possible scores on the QSU-B is 10-70, with higher values indicating an increased craving for cigarettes. This range of scores represent a total score; there are no subscales.~While the QSU-B was collected at all in-person sessions, we only analyzed the scores collected from the fMRI scanning sessions of each period (day 8 and day 29). To analyze, we averaged the total scores across all 20 subjects from each fMRI scanning session and statistically analyzed for significant differences between these two averages. This was a within-subject analysis."|Day 8 (fMRI scanning session) of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects|||units on a scale||Standard Deviation|Mean
1430902|NCT01001520|Secondary|Subjective Symptoms: Smoking Behavior|In order to determine if tolcapone (vs. placebo) would affect subject smoking behavior, we collected the daily number of cigarettes each subject smoked from Days 1 through 7 during each study medication period. This allowed us to calculate the average number of daily cigarettes smoked, across all subjects, during each study medication period (i.e., the average number of cigarettes/day smoked while all subjects took tolcapone and the average number of cigarettes/day smoked while all subjects took placebo). Then, we statistically assessed if there was a significant difference between these averages.|Days 1 through 7 of each study period|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||Average number of cigarettes smoked/day||Standard Deviation|Mean
1430903|NCT01001520|Secondary|Cognitive Performance: Reaction Time|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.~Specifically, we tested whether subjects, while taking tolcapone, would display increased average reaction time (in milliseconds) during the N-back working memory task compared to their performance while they took the placebo. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||Milliseconds||Standard Error|Mean
1430904|NCT01001520|Secondary|Cognitive Performance: Accuracy|"Subjects underwent two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each study medication period, after at least 24 hours of smoking abstinence, subjects completed an fMRI brain scan. During these fMRI scan sessions, participants completed computer tasks that were designed to test working memory and attention. These tasks were similar to computer games, in that participants would push a button in response to the pictures they see.~Specifically, we tested whether subjects, while taking tolcapone, would display increased accuracy during the N-back working memory task compared to their performance while they took the placebo. We measured accuracy by counting the absolute number of true positives scored (the number each subject got correct during the task). This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||Number of true positives||Standard Error|Mean
1430905|NCT01001520|Primary|"Measure of Brain Activity: Blood Oxygen Level Dependent (BOLD) fMRI Signal Change During the N-back Working Memory Task (Brain Region: Right Dorsolateral Prefrontal Cortex; Right DLPFC)"|"Subjects completed two, 11-day study medication periods (one taking active tolcapone; one taking placebo). On Day 8 of each period, after at least 24 hours of smoking abstinence, subjects had an fMRI scan to measure changes in brain activity that occur during a memory test. The subjects completed a commonly used working memory test referred to as the N-back. This test presented complex geometric figures on a projection screen for 0.5 seconds; each figure is separated by 2.5 seconds of black screen. There were 4 conditions requiring increasing memory demands: 0-back, 1-back, 2-back, & 3-back. Subjects had to respond to the target geometric figure that was separated by 0, 1, 2, or 3 figures before it is repeated. Between each condition, there was a brief rest period.~To identify brain signal change, we calculated the difference in the amount of brain activity detected by the fMRI scan for each condition compared to the rest periods. This was a within-subject analysis."|At fMRI scan sessions - Days 8 and 29|29 subjects completed both fMRI scan sessions; however, data from 9 subjects were excluded from analysis, due to either poor fMRI data quality, low task accuracy (defined as task scores falling two standard deviations below the mean), or a failure to respond to more than 30% of the task's items. Below, we report on the 20 remaining subjects.|||BOLD signal||Standard Error|Mean
1430906|NCT01001494|Secondary|Percentage of Patients Who Achieved at Least a 4-unit Decrease From Baseline in the SGRQ Total Score at Week 24 on Treatment|Number of patients who achieved a clinically meaningful improvement (≥4-units) in Saint George Respiratory Questionnaire (SGRQ) total score at week 24 on treatment|Week 24|Intention-to-treat (ITT) population: all randomised patients who took at least one dose of Investigational Medicinal Product and who had a baseline and at least 1 post-baseline FEV1 assessment.|||Percentage of participants|||Number
1430995|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
1430911|NCT01001442|Secondary|Time to Progression (TTP), Progression Free Survival (PFS) and Overall Survival (OS)|"Progressive disease~Requires any one or more of the following:~Increase of ≥ 25% from baseline in~Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL) (increases of ≥ 1 g/dL are sufficient to define relapse if starting M-component is ≥ 5 g/dL).~Urine M-component and/or (the absolute increase must be ≥ 200mg/24h).~Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be > 10 mg/dL.~Bone marrow plasma cell percentage: the absolute % must be ≥ 10% (relapse form CR as a 5% cutoff instead of 10%).~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder."|Starting with first study drug administration until death or 3 years from first study treatment.|The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data (n = 34).|||months||95% Confidence Interval|Median
1430912|NCT01001442|Secondary|Anti-tumor Activity of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma by Number of Participants With Objective Response(ORR) and/or Clinial Benefit(CBR) Based on the International Myeloma Working Group Uniform Response Criteria|sCR:CR+normal FLC+absence of clonal cells in BM; CR:Negative immunofixation,disappearance of soft tissue plasmacytomas +≤5% plasma cells in BM+normal FLC; VGPR:M-protein detectable by immunofixation,not on electrophoresis or 90% or greater reduction in serum M-protein+urine M-protein level <100mg per 24h,>90% decrease in the difference between involved/uninvolved FLC; PR:≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h or ≥50% decrease in the difference between involved/uninvolved FLC or ≥50% reduction in plasma cells, provided baseline bone marrow plasma cell percentage was ≥30%, ≥50% size reduction of soft tissue plasmacytomas; MR:25%-49% reduction of serum M-protein+reduction in 24h urinary M-protein by 50-89%(still >200 mg/24h),25-49% soft tissue plasmacytomas size reduction,no increase in size or number of lytic bone lesions; SD:no response or PD ORR: %of subjects with MR+PR+VGPR+CR+sCR CBR:ORR + %of subjects with SD.|On day 1 of each treatment cycle (on a monthly basis) starting with first study drug administration until Close Out visit (average 3.84 months).|ITT: The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).|||Participants|||Count of Participants
1430913|NCT01001442|Secondary|Multi-dose Pharmacokinetics Properties of BT062 - Cmax|"Multi-dose Pharmacokinetics properties of BT062 after intravenous (IV) Administration of escalating doses of BT062 as assessed by measuring intact BT062 conjugate.~Please note that not all subjects reached Cycle 4 due to early termination . A lower number of samples could be analyzed for Cycle 4."|Starting with first study drug administration until 30-day follow-up visit (average 4.99 months).|"Safety Population: The Safety population included all subjects who were enrolled and received at least~1 dose of BT062 (n = 35)."|||ng/ml||Full Range|Median
1430914|NCT01001442|Secondary|Qualitative and Quantitative Toxicities of BT062|"Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results.~The incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs)."|Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)|Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).|||Participants|||Count of Participants
1430915|NCT01001442|Primary|Maximum Tolerated Dose (MTD)|"The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD.~Only DLTs occurring in cycle 1 for each subject were counted in the dose escalation decisions.~Three subjects were treated at the first or newest dose level as available. If none of the 3 subjects experienced a DLT during Cycle 1, three subjects could be treated at the next dose level as available.~In case of a DLT the cohort was expanded to up to 6 subjects. If not more than 1 of these 6 subjects experienced a DLT during Cycle 1, a first subject could be treated at the next dose level.~If 2 or more of the 6 subjects experienced a DLT during Cycle 1 the dose escalation was stopped.~The highest dose level at which < 2 of 6 subjects experienced a DLT is defined as the MTD."|First 28-day cycle||||mg/m²|||Number
1430916|NCT01001442|Primary|Dose Limiting Toxicities (DLT) - Number of Participants With at Least 1 DLT|The primary safety variable was to determine the incidence of DLTs in subjects with relapsed or relapsed/refractory multiple myeloma treated with BT062.|Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)|"The Safety population included all subjects who were enrolled and received at least~1 dose of BT062 (n = 35)."|||Participants|||Count of Participants
1430917|NCT01001429|Secondary|Hemodynamic Stability Post Operatively in PACU|heart rate recorded at 30 min intervals in PACU up to 120 min|PACU to 2 hours post op||||beats per minute||Inter-Quartile Range|Mean
1430918|NCT01001429|Secondary|Post Operative Hemodynamic Stability|blood pressure documented at 30 minute intervals in PACU up to 120 min|2 hours in PACU||||mmHg||Inter-Quartile Range|Mean
1430919|NCT01001429|Secondary|Patient Satisfaction|1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent|measured prior to discharge up to 2 hours||||units on a scale||Full Range|Mean
1430920|NCT01001429|Secondary|Surgeon Satisfaction for Adequate Sedation at Completion of Procedure|surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent|immediately following the completion of the procedure up to one hour||||units on a scale||Full Range|Mean
1430921|NCT01001429|Secondary|Surgeon Satisfaction for Adequate Sedation|1=very poor, 2=poor,3=fair, 4=good, 5=excellent|at 10 minutes into the procedure||||units on a scale||Full Range|Mean
1430922|NCT01001429|Primary|Intraoperative Heart Rate Stability|Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm|Intraoperative up to 120 min||||beats per minute||Full Range|Mean
1430923|NCT01001429|Primary|Intraoperative Respiratory Stability|respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm|Intraoperative up to 120 min||||breaths per minute||Full Range|Mean
1430927|NCT01001403|Primary|Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)|Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. “Moderate” PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a “severe” form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.|during 5 min after reperfusion of liver graft||||participants|||Number
1430928|NCT01001390|Secondary|Number of Participants With Improvement in Gait Efficiency While Using an AFO|The difference of net oxygen consumption between wearing AFO and without wearing AFO (difference = wearing AFO - without wearing AFO) will be compared between the baseline study and one month later by using repeated measures analysis in which the effect of time will be tested controlling for other confounding variables.|One month after baseline evaluation|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.||||||
1430929|NCT01001390|Primary|Net Oxygen Consumption During the Six Minute Walk Test Among Study Participants Under the Two Walking Conditions, With and Without AFO.|Net oxygen consumption is calculated by the formula: [net oxygen consumption = walking oxygen consumption - sitting oxygen consumption], then adjusted by total mass in kg, including body mass, the mass of the socks, appropriate shoes, helmet, mouth piece system, and for the with AFO trials, the mass of the brace.|Baseline|No data was collected for analysis. Two participants were enrolled, however, neither participant agreed to wear an ankle foot orthoses.||||||
1430930|NCT01001377|Secondary|Number of Participants With Adverse Events (AEs)|Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.|From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.|Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.|||participants|||Number
1430931|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Functional Well-being Scale Score|The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from “0” to “4” representing “Not at All” through to “Very Much True”. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1430932|NCT01001377|Secondary|Change From Baseline in NCCN FCSI Physical Well-being Scale Score|"The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from 0 to 4 representing Not at All through to Very Much True. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more)."|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1430933|NCT01001377|Secondary|Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score|The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from “0” to “4” representing “Not at All” through to “Very Much True”. The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1430934|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as “Worst imaginable health state” and 100 labeled as “Best imaginable health state.” The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set participants with available data|||scores on a scale||95% Confidence Interval|Least Squares Mean
1430954|NCT01001299|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||hours||Full Range|Median
1430935|NCT01001377|Secondary|Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score|The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and –0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.|From Study Day 1 through the last day of treatment or disease progression, up to Week 85.|Patient reported outcomes (PRO) analysis set: all participants in the primary analysis set who have a Baseline and at least one follow-up PRO assessment prior to clinical or objective disease progression per RECIST version 1.1. Participants with available data are included.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1430936|NCT01001377|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set|||months||95% Confidence Interval|Median
1430937|NCT01001377|Secondary|Time to Response|Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response|||months||Inter-Quartile Range|Median
1430938|NCT01001377|Secondary|Duration of Response|Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Participants with an objective response|||months||95% Confidence Interval|Median
1430939|NCT01001377|Secondary|Objective Response|Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Tumor Response Analysis Set: Participants in the primary analysis set with at least 1 Baseline unidimensionally measurable lesion per RECIST version 1.1.|||percentage of participants||95% Confidence Interval|Number
1430940|NCT01001377|Secondary|Progression-free Survival|"Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.~Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions."|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary analysis set|||months||95% Confidence Interval|Median
1430941|NCT01001377|Primary|Overall Survival|Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.|From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.|Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.|||months||95% Confidence Interval|Median
1430942|NCT01001325|Primary|Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab|Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)|day +7 post seasonal influenza vaccination (or placebo) to end of study||||participants||95% Confidence Interval|Number
1430943|NCT01001299|Secondary|Progression-Free Survival (PFS)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in participants without disease progression were to be considered to be a PFS event on the date of death. Participants who neither progressed nor died were to be censored on the date of the last evaluable tumor assessment prior to the data cutoff date. PD, as assessed by investigator, was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
1430955|NCT01001299|Primary|Cmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1430944|NCT01001299|Secondary|Time to Response|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed CR or PR (as assessed by investigator), whichever occurred first. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
1430945|NCT01001299|Secondary|Duration of Response|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those participants whose best overall response was CR or PR, as assessed by investigator. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis <10 mm). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|The data for this outcome measure was not collected as the outcome was removed as per changes in planned analysis (protocol amendment).||||||
1430946|NCT01001299|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR)|Confirmed best overall response was defined as having best objective response as CR or PR, as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than [<] 10 millimeter [mm]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported.|Screening up to approximately 3.5 years (assessed at Screening, Day 1 of Cycle 3 thereafter Day 1 of every other cycle [every 2 months] and at end of study)|Efficacy population included all enrolled participants who received any vemurafenib and had at least one post-baseline tumor assessment.|||percentage of participants|||Number
1430947|NCT01001299|Primary|CL/F of Probe Parent Drugs on Day 20|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||mL/h||Standard Deviation|Mean
1430948|NCT01001299|Primary|Apparent Plasma Clearance (CL/F) of Probe Parent Drugs on Day 1|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the body. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||milliliters per hour (mL/h)||Standard Deviation|Mean
1430949|NCT01001299|Primary|t1/2 of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.|||hours||Standard Deviation|Mean
1430950|NCT01001299|Primary|Apparent Elimination Half-Life in Plasma (t1/2) of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome.|||hours||Standard Deviation|Mean
1430951|NCT01001299|Primary|Trough Plasma Concentration (Cmin) of Vemurafenib||Before morning dose (0 hour) on Day 19|Primary PK analysis population. Here, number of participants analyzed signifies participants with evaluable data for this outcome.|||mcg/mL||Standard Deviation|Mean
1430952|NCT01001299|Primary|Tmax of Vemurafenib||0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.|||hours||Full Range|Median
1430953|NCT01001299|Primary|Tmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||hours||Full Range|Median
1430990|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L/hr/m^2||Standard Deviation|Mean
1430956|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 20|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ng/mL||Standard Deviation|Mean
1430957|NCT01001299|Primary|Cmax of Probe Parent Drugs and Their Metabolites on Day 1|Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1430958|NCT01001299|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8, 12, and 24 Hours (AUC[0-8], AUC[0-12], AUC[0-24]) of Vemurafenib|Area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to 8, 12, and 24 hours (AUC[0-8], AUC[0-12], AUC[0-24], respectively).|0, 0.5, 1, 2, 4, 8, 12, 13, 14, 16, 18, 24 hours on Day 19|Primary PK analysis population.|||micrograms*hour/milliliter (mcg*h/mL)||Standard Deviation|Mean
1430959|NCT01001299|Primary|AUC(0-last) and AUC(0-inf) of Probe Parent Drugs and Their Metabolites on Day 20|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ng*hr/mL||Standard Deviation|Mean
1430960|NCT01001299|Primary|AUC(0-last) and Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Probe Parent Drugs and Their Metabolites on Day 1|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. AUC(0-inf) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero extrapolated to infinity. Timeframe reported for parent probe drug is also applicable for their metabolite except S-warfarin, as S-warfarin does not have a metabolite.|Day 1: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||nanograms*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
1430961|NCT01001299|Primary|Geometric Mean Ratio of AUC(0-last) and Cmax of Metabolites of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of AUC(0-last) and Cmax of metabolites of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) and Cmax (Day 20/Day 1) for each of the 4 probe drug metabolites is reported (paraxanthine [caffeine metabolite], dextrorphan [dextromethorphan metabolite], OH-midazolam [midazolam metabolite], OH-omeprazole (omeprazole metabolite); S-warfarin does not have a metabolite).|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for paraxanthine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120, dextrorphan 0.5, 1.5, 2, 12, 18, 48, OH-midazolam 0.08, 0.25, 0.5, 0.75, 2, 10, OH-omeprazole 0.5, 1.5, 2, 2.5, 12, 18 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ratio||90% Confidence Interval|Geometric Mean
1430962|NCT01001299|Primary|Geometric Mean Ratio of Maximum Plasma Concentration (Cmax) of Probe Parent Drugs|To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90% CI of Cmax of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of Cmax (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary PK analysis population. Number of Participants Analyzed = participants evaluable for this outcome and n = participants evaluable for specified category.|||ratio||90% Confidence Interval|Geometric Mean
1430963|NCT01001299|Primary|Geometric Mean Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Observed Sampling Time (AUC[0-last]) of Probe Parent Drugs|AUC(0-last) was defined as the area under the plasma concentration-time curve calculated using the linear trapezoidal rule from time zero to the last observed sampling time. To assess the potential for drug-drug interactions, the geometric mean ratios and corresponding 90 percent (%) confidence interval (CI) of AUC(0-last) of parent probe drug before (Day 1) and after treatment with vemurafenib (Day 20) was calculated. Ratio and corresponding 90% CI of AUC(0-last) (Day 20/Day 1) for each of the 5 probe drugs is reported.|Day 1, 20: 0, 1, 3, 4, 6, 8, 24 hours, additionally for caffeine 0.5, 1.5, 2, 12, 18, 48, 72, 96, 120,dextromethorphan 0.5, 1.5, 2, 12, 18, 48,midazolam 0.08, 0.25, 0.5, 0.75, 2, 10,omeprazole 0.5, 1.5, 2, 2.5, 12, 18,S-warfarin 12, 48, 72, 96, 120 hours|Primary pharmacokinetic (PK) population: all participants who received all planned doses of vemurafenib without dose modification/interruption up to Day 25 and all doses of 5 cocktail probes, without major protocol violation. Number of Participants Analyzed=participants evaluable for this outcome; n=participants evaluable for specified category.|||ratio||90% Confidence Interval|Geometric Mean
1430964|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
1430965|NCT01001234|Secondary|Pain Freedom at 2 Hours Post Dose in Participants Between 6 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
1430966|NCT01001234|Secondary|Pain Relief at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain relief was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 2 or 1 (mild or no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
1430967|NCT01001234|Primary|Pain Freedom at 2 Hours Post Dose in Participants Between 12 and 17 Years of Age|Pain intensity was assessed using a 5-Face Pain Scale ranging from 1=no pain to 5=very bad pain. Pain freedom was defined as a reduction in severity from a rating of 3, 4 or 5 (moderate or severe pain) at the Stage 2 baseline (15 minutes post Stage 1 dose) to a rating of 1 (no pain) at 2 hours post Stage 2 dose. Missing data were imputed by carrying forward the preceding Stage 2 pain intensity values. Missing Stage 2 baseline values were imputed by carrying forward the Stage 1 baseline value, if available.|2 hours post Stage 2 dose|Includes participants who did not respond to placebo in Stage 1, were randomized to and took Stage 2 study drug and had both Stage 2 baseline migraine severity (moderate or severe) and at least one post Stage 2 dose efficacy measurement prior to or including the 2 hour post dose time point. Those randomized to rizatriptan in Stage 1 were excluded.|||participants|||Number
1430968|NCT01001221|Primary|Objective Response Rate With MTD|"Objective response was defined as a confirmed complete response (CR) or a confirmed partial response (PR) during the treatment period, based on RECIST 1.1, as assessed by the Investigator.~CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm.~PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.~The objective response rate (ORR) was to be calculated as the proportion of participants with confirmed objective response relative to the total number of participants in the analysis population. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months|||||||
1430969|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1: Ratio Day 1/Day 8 for AUClast and AUC|Ratio Day 1/Day 8 for AUClast and AUC were calculated to assess the effect of cabazitaxel on gemcitabine exposure.|Day 1 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion) and Day 8 (7 to 9 timepoints from start of infusion up to 24h hours after the end of infusion)|Enrolled participants who received at least 1 part of a dose of study treatment and had valid Day 1 and Day 8 PK samples. Valid PK samples included at least 1 post treatment analyzable PK sample and no prohibited concomitant medications.|||ratio||Full Range|Mean
1430970|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
1430971|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Standard Deviation|Mean
1430972|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
1430973|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Full Range|Median
1430991|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L||Standard Deviation|Mean
1430974|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample and with no prohibited concomitant medications.|||ng/ml||Standard Deviation|Mean
1430975|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||ng*hr/ml||Standard Deviation|Mean
1430976|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Standard Deviation|Mean
1430977|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
1430978|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours||Full Range|Median
1430979|NCT01001221|Secondary|Pharmacokinetic of 2',2' Difluorodeoxyuridine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples collected for gemcitabine assay were used to assay gemcitabine metabolite, 2',2' difluorodeoxyuridine(dFdU).~2',2' difluorodeoxyuridine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng/ml||Standard Deviation|Mean
1430980|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L/m^2||Standard Deviation|Mean
1430981|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L/hr/m^2||Standard Deviation|Mean
1430982|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Volume of Distribution at Steady State (Vss)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L||Standard Deviation|Mean
1430983|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Total Plasma Clearance (CL)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||L/hr||Standard Deviation|Mean
1430984|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve (AUC)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||ng*hr/ml||Standard Deviation|Mean
1430985|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Terminal Half-life (t1/2z)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Two participants' assays could not be used in the analysis.|||hours (hr)||Standard Deviation|Mean
1430986|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
1430987|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Time to Maximum Concentration (Tmax)||7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||hours (hr)||Full Range|Median
1430988|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 8: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 8 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of infusion;~Gemcitabine + cabazitaxel: prior the start of infusion, immediately before the end of infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 8 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined|||ng/ml||Standard Deviation|Mean
1430989|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined. Five participants' assays could not be used in the analysis.|||L/m^2||Standard Deviation|Mean
1430997|NCT01001221|Secondary|Pharmacokinetic of Gemcitabine on Cycle 1 Day 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for gemcitabine assay were collected on Day 1 of cycle 1 at the following timepoints:~Cabazitaxel + Gemcitabine: prior the start of cabazitaxel infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1.5, 3.5 and 22.5 hours after the end of gemcitabine infusion;~Gemcitabine + cabazitaxel: prior the start of gemcitabine infusion, immediately before the end of gemcitabine infusion, 15, 30 minutes, 1, 1.5, 2.5, 9 and 23.5 hours after the end of cabazitaxel infusion;~Gemcitabine plasma concentrations were determined using validated LC-MS/MS methods with a LLOQ of 50 ng/mL.~PK parameters were calculated from plasma concentrations using non-compartmental analysis."|7 to 9 timepoints from start of Day 1 infusion up to 24h hours after the end of infusion depending on the sequence of treatment on Day 1|PK population as previously defined.|||ng/ml||Standard Deviation|Mean
1430998|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State Normalized to Body Surface Area (Vss/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assays could not be used for Vss/BSA.|||L/m^2||Standard Deviation|Mean
1430999|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance Normalized to Body Surface Area (CL/BSA)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL/BSA.|||L/hr/m^2||Standard Deviation|Mean
1431000|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Volume of Distribution at Steady State (Vss)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. One participant's assay could not be used for Vss.|||L||Standard Deviation|Mean
1431001|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Total Plasma Clearance (CL)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for CL.|||L/hr||Standard Deviation|Mean
1431002|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Terminal Half-life (t1/2z)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined|||hours (hr)||Standard Deviation|Mean
1431003|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve (AUC)|Area under the plasma concentration versus time curve extrapolated to infinity|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined. Six participants' assays could not be used for AUC.|||ng*hr/ml||Standard Deviation|Mean
1431004|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Area Under the Time Concentration Curve From Time 0 To the Real Time Tlast (AUClast)|Area under the plasma concentration versus time curve calculated using the trapezoidal method from time 0 to the last measurable concentration at time t.|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined|||ng*hr/ml||Standard Deviation|Mean
1431005|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Time to Maximum Concentration (Tmax)||before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population as previously defined|||hours (hr)||Full Range|Median
1431006|NCT01001221|Secondary|Pharmacokinetic of Cabazitaxel on Cycle 1: Maximum Plasma Concentration Observed (Cmax)|"Blood samples for cabazitaxel assay were collected during cycle 1 and cabazitaxel plasma concentrations were determined using a validated liquid chromatography with tandem mass spectometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 1 ng/mL.~Pharmacokinetic (PK) parameters were calculated from plasma concentrations using non-compartmental analysis."|before the start of infusion and 5 minutes before the end of infusion, then 5, 15, 30 minutes, 1, 2, 3, 5, 7, 10, 24, 48, 72, 120 and 168 hours after the end of infusion|PK population: All enrolled participants who received at least 1 part of a dose of study treatment and had at least 1 post treatment analyzable PK sample, and with no prohibited concomitant medications|||ng/ml||Standard Deviation|Mean
1431007|NCT01001221|Post-Hoc|Participant Best Response as Per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|"Participant Best response was assessed by investigator using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1:~Complete response (CR): Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm:~Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion;~Progressive disease (PD): >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions;~Stable disease (SD): not a CR, PR or PD."|Up to a maximum of 22 cycles (median 4 cycles)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment.|||participants|||Number
1431008|NCT01001221|Secondary|Participants With Adverse Events|"Summary of participants with adverse events (AEs) according to severity and relationship to study drug as assessed by the investigator. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used to grade the severity of AE.~Treatment-emergent adverse events (TEAEs) are AEs that occurred or worsened from start of treatment up to 30 days after treatment ceased.~NCI CTCAE v.3.0 grade 3 =severe and grade 4= life-threatening or disabling."|from first dose of study medication up to 30 days after the last dose of study medication (maximum follow-up of 68 weeks)|all treated (AT) population: All enrolled participants who received at least 1 part of a dose of study treatment|||participants|||Number
1431527|NCT00997984|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|up to 8 weeks|FAS|||Percent of Participants|||Number
1431009|NCT01001221|Secondary|Duration of Response With MTD|"Duration of Response (DR) was defined as the time from the first documentation of RECIST-defined objective tumor response to the first documentation of RECIST-defined objective tumor progression or death.~Median DR was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months|||||||
1431010|NCT01001221|Secondary|Time To Progression With MTD|"Time to progression (TTP) was defined as the time from first treatment administration to first documentation of RECIST-defined objective tumor progression (>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of >=1 new lesion and/or unequivocal progression of existing non-target lesions).~Median TTP was to be estimated using the Kaplan-Meier method. Due to the inability to determine MTD during the study part 1, the analysis was not performed."|Fron Day 1 up to a maximum of 12 months|||||||
1431011|NCT01001221|Primary|Participants With Dose Limiting Toxicities During Dose Escalation|Dose Limiting Toxicities (DLTs) were defined as clinical adverse events (AE) or laboratory abnormalities considered drug-related as assessed by the Investigator or Sponsor, and achieving a Common Terminology Criteria for Adverse Events v3.0 (CTCAE) severity rating of severe (3) or life-threatening (4).|Day 1 to Day 21 of the first treatment cycle|"DLT population: All participants who completed assessments for DLT evaluation for Cycle 1 and either:~received study treatment during Cycle 1 and had DLT or~did not have DLT and received a full dose of study treatment (no delay/reduction) during Cycle 1 and did not receive hematopoietic growth factors."|||participants|||Number
1431012|NCT01001208|Secondary|Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 24 score; a positive change from Baseline therefore indicates improvement.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of BSA||Standard Deviation|Mean
1431013|NCT01001208|Secondary|Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12|A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 12 score; a positive change from Baseline therefore indicates improvement.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of BSA||Standard Deviation|Mean
1431014|NCT01001208|Secondary|PASI 90 Response at Week 24|Percentage of participants achieving at least a 90% decrese (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
1431015|NCT01001208|Secondary|PASI 90 Response at Week 12|Percentage of participants achieving at least a 90% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
1431016|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 12|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 12. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
1431017|NCT01001208|Secondary|PASI 75 Response at Week 12|Percentage of participants achieving at least a 75% decrease (i.e. improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used|||Percentage of participants|||Number
1431018|NCT01001208|Secondary|PASI 50 Response at Week 12|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 12 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
1431019|NCT01001208|Secondary|Static Physician Global Assessment (sPGA) Response at Week 24|Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 24. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.|Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
1431068|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks|Percentage of participants achieving HbA1c<6.5% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).|||percentage of participants|||Number
1431020|NCT01001208|Secondary|PASI 50 Response at Week 24|Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
1431021|NCT01001208|Primary|PASI 75 Response at Week 24|Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.|Baseline and 24 Weeks|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.|||Percentage of participants|||Number
1431022|NCT01001195|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 29 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1431023|NCT01001169|Secondary|Number of Subjects With Normal or Abnormal Values of Haematological Parameters|"Among haematological parameters assessed were Basophils (Baso), Eosinophils (EOS), Hematocrit (HEM), Hemoglobin (Hgb), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLA), Red Blood Cells (RBC) and White Blood Cells (WBC).~Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter."|At Days 0, 7 and 42|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Subjects|||Number
1431024|NCT01001169|Secondary|Number of Subjects With Normal or Abnormal Biochemical Levels|"Among biochemical parameters assessed were Alanine Amino Transferase (ALAT), Albumin, Alkaline Phosphatase (AP), Aspartate Amino Transferase (ASAT), Bilirubin, Bilirubin Conjugated/Direct, Cholesterol, Chloride, Creatinine, Creatine Phosphokinase (CK), Gamma-Glutamyl Transpeptidase (GGT), Potassium, Lactate dehydrogenase (LDH), Sodium, Protein, Urate/Uric acid and Blood Urea Nitrogen (BUN).~Unknown = value unknown for the specified time point and laboratory parameter; Below = value below the laboratory reference range defined for the specified time point and laboratory parameter; Within = value within the laboratory reference range defined for the specified time point and laboratory parameter; Above = value above the laboratory reference range defined for the specified time point and laboratory parameter."|At Days 0, 7 and 42|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431025|NCT01001169|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431026|NCT01001169|Secondary|Number of Subjects With Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431027|NCT01001169|Secondary|Number of Subjects With Medically Attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|During the entire study period (from Day 0 to Day 182)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431028|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to 84 days (Days 0-83) after the first vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431029|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location, muscle aches, shivering, sweating, and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0°C - ≤ 40.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431069|NCT01001104|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks|Percentage of participants who achieved HbA1c<7% up to the 12-week endpoint.|up to 12 weeks|All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).|||percentage of participants|||Number
1431030|NCT01001169|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptoms regardless of their intensity grade or their relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever ≥ 39.0 °C - ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431031|NCT01001169|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain [child below (<) 6 years] = cried when limb was moved/spontaneously painful. Grade 3 pain [child equal to or above (≥) 6 years] = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on The Total Vaccinated Cohort which included all vaccinated subjects.|||Subjects|||Number
1431032|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
1431033|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431034|NCT01001169|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1|VRR is defined as the number of vaccinees that have a 4-fold increase between pre- and post-vaccination titers. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
1431035|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
1431036|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||95% Confidence Interval|Geometric Mean
1431037|NCT01001169|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1431038|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
1431039|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431246|NCT01000285|Primary|Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.|Up to 30 days after completion of treatment||||participants|||Number
1431040|NCT01001169|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine neutralizing antibodies were equal to or above (≥) 1:8. The Flu strain assessed was Flu A/Neth/602/09 H1N1, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against Flu A/Neth/602/09 H1N1 antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
1431041|NCT01001169|Secondary|SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5."|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
1431042|NCT01001169|Secondary|SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||95% Confidence Interval|Geometric Mean
1431043|NCT01001169|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for SCF was > 2.5."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1431044|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%."|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
1431045|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431046|NCT01001169|Secondary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SPR was > 70%."|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
1431047|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%."|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
1431048|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431049|NCT01001169|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CHMP Criterion was fulfilled if the point estimate for SCR was > 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
1431050|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
1431051|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||95% Confidence Interval|Geometric Mean
1431052|NCT01001169|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
1431053|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 182 were available.|||Subjects|||Number
1431054|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|"The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance.~Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed."|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431055|NCT01001169|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after the first vaccination were available.|||Subjects|||Number
1431056|NCT01001169|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance.~The CHMP Criterion was fulfilled if the point estimate for GMFR was > 2.5."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||97.5% Confidence Interval|Geometric Mean
1431057|NCT01001169|Primary|Number of Seroprotected Subjects for HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was > 70%.~The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431070|NCT01001104|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1431058|NCT01001169|Primary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion (SCR) was defined as follows:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.~The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was > 40%.~The CHMP criterion was fulfilled if the point estimate for SCR was > 40%."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431059|NCT01001169|Primary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Titers||97.5% Confidence Interval|Geometric Mean
1431060|NCT01001169|Primary|Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value|"The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10.~The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance."|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood samples taken on Day 42 (21 days after the second vaccination) were available.|||Subjects|||Number
1431061|NCT01001104|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period|Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L).|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage of participants|||Number
1431062|NCT01001104|Secondary|Steady-State Concentrations of LY2189265|Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®.|12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
1431063|NCT01001104|Secondary|Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks|HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage beta-cell function||95% Confidence Interval|Least Squares Mean
1431064|NCT01001104|Secondary|Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks|HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||percentage insulin sensitivity (%S)||95% Confidence Interval|Least Squares Mean
1431065|NCT01001104|Secondary|Change From Baseline in Total Body Weight at 12 Weeks|Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
1431066|NCT01001104|Secondary|Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks|SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
1431067|NCT01001104|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks|Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose*visit, where the participant was treated as a random effect.|Baseline, 12 weeks|Full analysis set: All randomized participants who received at least 1 dose of the study drug.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
1431071|NCT01001078|Secondary|Airway Manipulation and Blood on Device at Removal||During and after anesthesia when the device is removed.||||participants|||Number
1431072|NCT01001078|Secondary|Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)|Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.|On the day following surgery|"5 participants were lost to follow-up and 4 participants had the crossover device or were intubated in the I-Gel group.~4 participants were lost to follow-up and 3 participants had the crossover device or were intubated in the LMA Supreme group (one of participants was lost to follow-up and had the crossover device or was intubated)"|||participants|||Number
1431073|NCT01001078|Secondary|Number of Participants With Successful Attempts to Introduce the Devices||At the beginning of anesthesia before the beginning of the surgery.||||participants|||Number
1431074|NCT01001078|Secondary|Time Needed to Secure the Airway||From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.||||seconds||Standard Deviation|Mean
1431075|NCT01001078|Secondary|Measure of the Peak Airway Pressure||After introduction of the SAD before the beginning of the surgery.||||cm H20||Standard Deviation|Mean
1431076|NCT01001078|Primary|Measure of the Airway Leak Pressure||After introduction of the supraglottic device before the beginning of the surgery.||||cmH2O||Standard Deviation|Mean
1431077|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colcrys™|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose||||ng*hr/mL||Standard Deviation|Mean
1431078|NCT01001052|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Colcrys™|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose||||ng*hr/mL||Standard Deviation|Mean
1431079|NCT01001052|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1431080|NCT01000987|Primary|Cognitive Function as Measured by Omissions on the CPT|"Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with stop and go targets that appear on a computer screen. They are told to press the space bar (respond) to go targets and to avoid pressing the space bar when stop targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324)."|Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption.||||Number of Omissions||Standard Error|Mean
1431081|NCT01000974|Secondary|Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.|pre-booster and one month after booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||EL.U/mL||95% Confidence Interval|Geometric Mean
1431082|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.|||Subjects|||Number
1431083|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0 to Day 30) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.|||Subjects|||Number
1431084|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From booster dose until 6 months following receipt of the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.|||Subjects|||Number
1431085|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C).|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.|||Subjects|||Number
1431247|NCT01000155|Secondary|γ-globin to β-globin Ratio|Levels of peripheral blood γ-globin to β-globin messenger RNA were estimated based on established methods. The ratio of γ-globin to β-globin was then calculated.|Measured at baseline and end of treatment, up to 16 weeks.|The analysis dataset is comprised of all treated patients.|||Change in γ-globin to β-globin ratio||Full Range|Median
1431086|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|Within 4 days (Days 0-3) following the booster dose|Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.|||Subjects|||Number
1431087|NCT01000974|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.|Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Subjects|||Number
1431088|NCT01000974|Secondary|Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8|Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated.|Prior to booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Subjects|||Number
1431089|NCT01000974|Secondary|Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8|Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers.|Prior to the booster vaccination|The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1431090|NCT01000974|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL|Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||Subjects|||Number
1431091|NCT01000974|Secondary|Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL|The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).|Prior to booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||Subjects|||Number
1431092|NCT01000974|Secondary|Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL|Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL).|Prior to the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
1431093|NCT01000974|Secondary|Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations|Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1431094|NCT01000974|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values|The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1431095|NCT01000974|Secondary|Antibody Titers for Poliovirus Types 1, 2 and 3|Antibody titers were given as geometric mean titers(GMTs).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1431096|NCT01000974|Secondary|Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL|Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination.|At 1 month after the last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP)cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1441653|NCT00923260|Primary|Components of Metabolic Syndrome (High-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
1431097|NCT01000974|Secondary|Anti-Hepatitis B (Anti-HBs) Antibody Concentrations|Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
1431098|NCT01000974|Secondary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL|Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose.|Prior to the booster vaccination and 1 month after the booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||Subjects|||Number
1431099|NCT01000974|Secondary|Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL|Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1431100|NCT01000974|Secondary|Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA|Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1431101|NCT01000974|Secondary|Number of Subjects With AEs of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.|||Subjects|||Number
1431102|NCT01000974|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 until 6 months following the last primary dose|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.|||Subjects|||Number
1431103|NCT01000974|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-Day 30) follow-up period after primary vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.|||Subjects|||Number
1431104|NCT01000974|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and symptom sheets completed.|||Subjects|||Number
1431105|NCT01000974|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.|During a 4-day follow-up period (Days 0-3) following any vaccination|The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and with symptom sheets completed.|||Subjects|||Number
1431106|NCT01000974|Secondary|Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
1431107|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL|Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP|At 1 month after booster vaccination|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose|||Subjects|||Number
1431108|NCT01000974|Primary|Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value|"The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity).~The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals’ SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database."|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1431109|NCT01000974|Primary|Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)|Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1431110|NCT01000974|Primary|Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations|Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1431111|NCT01000974|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1431112|NCT01000974|Primary|Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations|Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||µg/mL||95% Confidence Interval|Geometric Mean
1431113|NCT01000974|Primary|Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)|Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus.|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1431114|NCT01000974|Primary|Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL|Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).|At 1 month after last dose of primary vaccination|The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.|||Subjects|||Number
1431115|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, AUC(0-t), Between RP103 and Cystagon®.||6 hours post dosing for Cystagon®; 12 hours post dosing for RP103.||||AUC(0-t) (min*mg/L)||Standard Deviation|Least Squares Mean
1431116|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Tmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study||||Tmax (minute)||Standard Deviation|Least Squares Mean
1431117|NCT01000961|Secondary|Comparison of Cysteamine PK Profiles, Steady State Cmax, Between RP103 and Cystagon®.||4 weeks after the last subject has completed the study||||Cmax (mg/L)||Standard Deviation|Least Squares Mean
1431118|NCT01000961|Primary|The Steady-state White Blood Cell Cystine Levels of RP103 Compared to Cystagon®||4 weeks after the last subject has completed the study||||nmol ½ Cystine / mg protein||Standard Error|Least Squares Mean
1431119|NCT01000818|Primary|Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir|Area Under the Plasma Concentration-Time Curve and peak concentration|12 hours postdose|Eighteen HIV-Infected Patients|||µM*hr||95% Confidence Interval|Geometric Mean
1431120|NCT01000805|Secondary|Change From Baseline in Weight up to Week 8|"The change from baseline in weight at week 8 is the primary analysis. For the primary analysis of weight, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in weight up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: All randomized participants with a baseline and at least 1 nonmissing post-baseline result, Last Observation Carried Forward (LOCF)."|||kilograms (kg)||Standard Error|Least Squares Mean
1431248|NCT01000155|Secondary|F-Cell Percentage Level|F-cell percentage levels were estimated based on established methods.|Measured at baseline and end of treatment, up to 16 weeks.|The analysis dataset is comprised of all treated patients.|||F-cell percentage||Full Range|Median
1431121|NCT01000805|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8|"The change from baseline in SBP and DBP at week 8 is the primary analysis. For the primary analysis of SBP and DBP, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in SBP and DBP up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, Last Observation Carried Forward (LOCF)."|||mm Hg||Standard Error|Least Squares Mean
1431122|NCT01000805|Secondary|Change From Baseline in Pulse Rate up to Week 8|"The change from baseline in pulse rate at week 8 is the primary analysis. For the primary analysis of pulse rate, the Least Squares (LS) Mean Value was adjusted for treatment, investigator, baseline, treatment*visit interaction, and baseline*visit interaction.~The change from baseline in pulse rate up to week 8 is the secondary analysis. The LS Mean Value was adjusted for treatment, investigator, and baseline."|Baseline, up to week 8|"Primary analysis: All randomized participants with a baseline and at least 1 post-baseline result.~Secondary analysis: Intention-to-treat population (ITT) with nonmissing baseline value and at least 1 nonmissing post-baseline value, LOCF."|||beats per minute (bpm)||Standard Error|Least Squares Mean
1431123|NCT01000805|Other Pre-specified|Number of Participants With Abnormal Laboratory Values During the Double-blind Treatment Phase – High Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT)|Laboratory assessment of ALT/SGPT during the double-blind treatment phase. Normal ALT/SGPT ranges for males are 6.00 units per liter (U/L) (low) to 43.00 U/L (high). Normal ALT/SGPT ranges for females are 6.00 U/L (low) to 34.00 U/L (high).|Baseline through 8 weeks|All randomized participants with a normal baseline (respective to the specified direction) and at least 1 post-baseline result.|||participants|||Number
1431124|NCT01000805|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and completed suicide. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal acts: a yes answer to actual attempt or completed suicide."|Baseline through 8 weeks|All randomized participants with at least 1 post-baseline C-SSRS result.|||participants|||Number
1431125|NCT01000805|Secondary|Patient's Global Impressions of Improvement Scale (PGI-I) at Week 8|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.|8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1431126|NCT01000805|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference=average of nonmissing scores of individual interference items. LS Mean Value adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1431127|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 2|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 2 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1431128|NCT01000805|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 4|The MADRS is a rating scale for severity of depressive mood and symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 4 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1431129|NCT01000805|Secondary|Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing consecutive visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).|Up to 8 weeks|All randomized participants with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
1431130|NCT01000805|Secondary|Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8|The Montgomery Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Remission is defined as achieving a MADRS total score ≤12.|Baseline, up to 8 weeks|All randomized participants with a post-baseline result, Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
1431264|NCT01000025|Primary|Overall Survival|Median and 95% confidence intervals|42 Months|ITT|||Months||95% Confidence Interval|Median
1431131|NCT01000805|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8|SDS is completed by participant; used to assess effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30; higher values indicate greater disruption in the participant's work/social/family life. Each item score ranges from 0 to 10 with higher values indicating greater disruption in the participant's work/school life (item 1), social life/leisure activities (item 2), or family life/home responsibilities (item 3). The LS Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1431132|NCT01000805|Primary|Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1431133|NCT01000805|Primary|Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.|Day 1 through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1431134|NCT01000727|Secondary|Number of Participants With All-cause Mortality During the Time Period for Vital Status|Number of participants who died, during the vital status time-period were reported. The participants who were known to have died, date of death was used; for participants who completed the study the study completion date was used; for participants who withdrew from the study where vital status was ascertained , and are known to have not died , the last known date to be alive was used and for participants whom vital status was not ascertained, following study withdrawal the study withdrawal date was used.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431135|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431136|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431137|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event|All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included. Examples include coronary artery bypass graft, balloon angioplasty and stenting. The number of participants, with first occurrence of any coronary revascularization procedures, were reported.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431138|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events|CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431139|NCT01000727|Secondary|Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events|Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft [CABG]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization. PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431140|NCT01000727|Secondary|Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events|CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431141|NCT01000727|Secondary|Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events|Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431142|NCT01000727|Secondary|Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431143|NCT01000727|Secondary|Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events|CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431144|NCT01000727|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events|CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized ITT Population|||Participants|||Count of Participants
1431145|NCT01000727|Primary|Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event|Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)|All-Randomized intent-to-treat (ITT) Population consisted of all randomized participants.|||Participants|||Count of Participants
1431146|NCT01000662|Secondary|Late Radiation Toxicities Recorded According to LENT/SOMA||yearly for five years after completion of treatment|||||||
1431147|NCT01000662|Secondary|QOL (Quality of Life) Questionnaire of Patients on the 2 Different Arms of Treatment||at baseline, at the end of last week of treatment, and at 2 year Follow-up|||||||
1431148|NCT01000662|Primary|Acute Radiation Toxicities Recorded According to Radiation Therapy Oncology Group (RTOG)|Proportion of patients with a grade 2 or greater toxicity after 3 weeks of whole breast IMRT with a once/week boost compared to those patients treated with a daily boost: 0 - no symptoms, 5 - death directly related to radiation effects|Day 1 of radiation treatment to day 60|Patients receiving either daily or weekly boost to radiation therapy|||participants|||Number
1431162|NCT01000649|Primary|Infusion Rates of Open Label NE.|"Mean open label NE infusion rate within each predefined time period.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||µg/kg/min||Standard Deviation|Mean
1431149|NCT01000649|Secondary|Incidence of Abnormal Changes in ECG|"The number of patients having abnormal changes in ECG variables during the trial period was presented.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||Number of patients|||Number
1431150|NCT01000649|Secondary|Mortality|"Mortality was assessed as percentage of patients dead at pre-specified time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, 7, 14, and 28|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of patients|||Number
1431151|NCT01000649|Secondary|Percentage of Days Alive and Free of Ventilation|"Percentage of days alive and free of ventilation was assessed on Days 7, 14, and 28.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of days||Standard Deviation|Mean
1431152|NCT01000649|Secondary|Percentage of Days Alive and Free of Dialysis|"Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7, Day 14 and Day 28|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of days||Standard Deviation|Mean
1431153|NCT01000649|Secondary|Percentage of Patients Alive and Free of All Vasopressors|"Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7, Day 14 and Day 28|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of patients|||Number
1431154|NCT01000649|Secondary|Days Alive and Free of Any Organ Dysfunction at Day 7|"Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7).~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Percentage of days||Standard Deviation|Mean
1431155|NCT01000649|Secondary|Change From Baseline in Arterial Blood Gas (Lactate)|"Change from Baseline in arterial blood gas (lactate) was observed at each time-point.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||mmol/L||Standard Deviation|Mean
1431156|NCT01000649|Secondary|Pulmonary Function : Change From Baseline in Tidal Volume|"Change from Baseline in tidal volume was observed at each time-point.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||mL/kg||Standard Deviation|Mean
1431157|NCT01000649|Secondary|Pulmonary Function : Change From Baseline in PaO2/FiO2|"Change from Baseline in PaO2/FiO2 was observed at each time-point.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||Ratio||Standard Deviation|Mean
1431158|NCT01000649|Secondary|SOFA Score|"The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst).~Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7, Day 14 and Day 29|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Score on a scale||Standard Deviation|Mean
1431159|NCT01000649|Secondary|Change From Baseline in Fluid Balance|"The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||mL/hour/kg||Standard Deviation|Mean
1431160|NCT01000649|Secondary|Change From Baseline in Heart Rate|"The change from Baseline in heart rate was analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Safety Analysis Set, which comprised of all patients who were dosed.|||Beats per minute||Standard Deviation|Mean
1431161|NCT01000649|Secondary|Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist|"The change from Baseline in IL-1R levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||µg/L||Standard Deviation|Mean
1441654|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
1431163|NCT01000649|Secondary|Change From Baseline in Interleukin-10 (IL-10)|"The change from Baseline in IL-10 levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/L||Standard Deviation|Mean
1431164|NCT01000649|Secondary|Change From Baseline in Interleukin-6 (IL-6)|"The change from Baseline in IL-6 levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/L||Standard Deviation|Mean
1431165|NCT01000649|Secondary|Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha|"The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|At Day 1, Day 2, Day 4, and Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/L||Standard Deviation|Mean
1431166|NCT01000649|Secondary|Change From Baseline in C-reactive Protein (CRP)|"The change from Baseline in CRP levels were analysed and presented as per the planned time points.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||mg/L||Standard Deviation|Mean
1431167|NCT01000649|Secondary|PK Parameter in Patients : Terminal Elimination Half-life|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Hour||Standard Deviation|Mean
1431168|NCT01000649|Secondary|PK Parameter in Patients : Initial Elimination Half-life|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Hour||Standard Deviation|Mean
1431169|NCT01000649|Secondary|PK Parameter in Patients : Steady State Volume of Distribution|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Litre||Standard Deviation|Mean
1431170|NCT01000649|Secondary|PK Parameter in Patients : Clearance|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Litre/hour||Standard Deviation|Mean
1431171|NCT01000649|Secondary|PK Parameter in Patients : Time to Steady State|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||Hour||Standard Deviation|Mean
1431172|NCT01000649|Secondary|Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration|"PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of FAS, which comprised of all patients who were dosed.|||ng/mL||Standard Deviation|Mean
1431173|NCT01000649|Primary|Cumulative Dose of Open Label NE.|"Cumulative Dose of Open Label NE over 7 days.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.|||µg/kg||Standard Deviation|Mean
1431174|NCT01000649|Primary|Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE|"Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.|||Percentage of patients||95% Confidence Interval|Number
1431175|NCT01000649|Primary|Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)|"Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.~The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome."|Day 1 up to Day 7|The analysis population consist of Full Analysis Set, which comprised of all patients who were dosed.|||Percentage of patients||95% Confidence Interval|Number
1431176|NCT01000610|Secondary|Change in Bone Density (in Participants Untreated With Bisphosphonates)|Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.|Screening and Week 84|ITT population; only participants with an assessment at both screening and Week 84 were included in the analysis.|||t-score|||Number
1431177|NCT01000610|Secondary|Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.|||percentage of participants|||Number
1431178|NCT01000610|Secondary|Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.|Baseline and Week 24|ITT population; Only participants with DAS28 values at both Baseline and Week 24 were included in the analysis.|||percentage change from baseline||Standard Deviation|Mean
1431179|NCT01000610|Primary|Number of Participants Reporting Adverse Events (AEs)||Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks|Safety Population: Included all participants who have received any part of an infusion of study medication.|||number of participants|||Number
1431180|NCT01000506|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score Over the 52-week Treatment Period|The ACQ-6 is a six-item questionnaire. The six questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze) and use of short-acting bronchodilator over the previous week. The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 6 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Change from BL is defined as the difference between the value of the endpoint at the time point of interest and BL value. Analysis was performed using mixed model repeated measures with covariates of BL, region, BL maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1, treatment and visit, plus interaction terms for visit by BL and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.|||Scores on a scale||Standard Error|Least Squares Mean
1431181|NCT01000506|Secondary|Mean Change From Baseline in Clinic Post-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Post-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 32 and Week 52. Post bronchodilator values were recorded following reversibility testing, using the maximum post bronchodilator method. Participants unable to achieve >=12% reversibility and 200 mL change at Visit 1, reversibility test was repeated at Visit 2. These procedures to achieve the maximum post-bronchodilator are generated by the Asthma Clinical Research Network. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.|||mL||Standard Error|Least Squares Mean
1431182|NCT01000506|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at each clinic visit. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Analysis was performed using mixed model repeated measures with covariates of Baseline, region, Baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|From Baseline up to Week 52 or EW|ITT Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X, X, X, X respectively.|||Milliliters (mL)||Standard Error|Least Squares Mean
1431183|NCT01000506|Secondary|Time to First All Recorded Exacerbation|All recorded exacerbations are defined as those recorded by investigators, regardless of the outcome of the exacerbation review process. In the case, an event described as an exacerbation was not associated with a deterioration in at least one of the objectives of eDiary parameters, the investigator provided an explanation to support the decision for defining the event as an exacerbation. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by week 16, week 32 and week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population|||Percentage of participants||95% Confidence Interval|Number
1431184|NCT01000506|Secondary|Number of All Recorded Exacerbations Per Year|Clinically significant exacerbations (ex) of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for par. on maintenance OCS, an ex requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. In the case, an event described as an ex was not associated with a deterioration in >=1 of the objectives of eDiary parameters, the investigator (inv) provided an explanation to support the decision for defining the event as an ex. All recorded ex were defined as those recorded by inv, regardless of the outcome of the ex review process. Analysis was performed using Negative Binomial regression model with covariates of treatment group, BL maintenance OCS therapy (OCS vs. no OCS), region, ex in the year prior to the study (as an ordinal variable) and BL % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population|||Exacerbations per year|||Number
1431185|NCT01000506|Secondary|Time to First Exacerbation Requiring Hospitalization or ED Visit|Exacerbations of asthma requiring hospitalization or ED visit were assessed. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population|||Percentage of participants||95% Confidence Interval|Number
1431186|NCT01000506|Secondary|Number of Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visit Per Year|The frequency of exacerbations of asthma requiring hospitalization (including intubation and admittance to an intensive care unit [ICU]) or ED visit over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 52 or EW|ITT Population|||Exacerbations per year|||Number
1431187|NCT01000506|Secondary|Time to First Clinically Significant Exacerbation Requiring Oral or Systemic Corticosteroid, Hospitalization and/ or ED Visit|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance OCS, an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or ED visit. Kaplan-Meier estimates of the probability of an exacerbation is expressed as percentage of participants with an exacerbation over time (by Week 16, Week 32 and Week 52).|From randomization (Week 0) to Week 52 or EW|ITT Population|||Percentage of participants||95% Confidence Interval|Number
1431188|NCT01000506|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of oral/systemic corticosteroids (for participants on maintenance oral corticosteroids [OCS], an exacerbation requiring OCS is defined as the use of oral/systemic corticosteroids at least double the existing maintenance dose for at least 3 days) and/or hospitalization and/or emergency department (ED) visit. The frequency of clinically significant exacerbations of asthma over the 52-week treatment period is expressed as exacerbation rate per year. Analysis of the number of exacerbations was performed using a negative binomial regression model with covariates of treatment group, Baseline (BL) maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and BL percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable|From randomization (Week 0) to Week 52 or early withdrawal (EW)|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.|||Exacerbations per year|||Number
1431189|NCT01000493|Secondary|Number of Participant by Maximum Suicidal Ideation, Based on the C-SSRS During and Post Treatment|The C-SSRS used to assess severity and change of suicidality by integrating both behavior and ideation and to be completed by the participants. The SSRS track change in the severity/density of suicidality. It assessed intensity of ideation (a potentially important marker of severity), specifically asking about frequency, duration, intrusiveness, controllability, and deterrents. The interview was initiated with 5 (yes/no) questions; rated on 1-5 point scale, presented in ascending order of severity, about suicidal ideation. The clinician asked 5 questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation without intent to act, active suicidal ideation with any methods (not plan) without intent to act and active suicidal ideation with specific plan and intent. Participants analyzed were number of participants with at least one C-SSRS assessment after the first dose of study medication (that is on treatment or post treatment).|Baseline, Week 1, 2, 4, 6, 8, 10, 12 and Day 14 of follow-up (approximately 14 weeks)|All subject population. Only those participants available at the time of indicated time points were analyzed.|||Participants|||Number
1431190|NCT01000493|Secondary|Number of Participant With Suicidal Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During and Post Treatment|The C-SSRS used to assess severity and change of suicidality by integrating both behavior and ideation and to be completed by the participants. The SSRS track change in the severity/density of suicidality. The interview was initiated with 5 (yes/no) questions; rated on 1-5 point scale, presented in ascending order of severity, about suicidal ideation. If the answers to the first 2 ideation questions were “yes,” the clinician asked questions 3-5. If the answers to ideation questions 1 and 2 were “no,” then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt and preparatory acts or behaviors. Participants analyzed were number of participants with at least one C-SSRS assessment after the first dose of study medication (that is on treatment or post treatment).|Baseline, Week 1, 2, 4, 6, 8, 10, 12 and Day 14 of follow-up (approximately 14 weeks)|All subject population. Only those participants available at the time of indicated time points were analyzed.|||Participants|||Number
1431219|NCT01000337|Primary|Changes in the M30 and M65 Markers Related to the Anesthesia Type|Blood samples for determination of the markers M30 and M65 as well as the serum transaminases were collected preoperatively, at the end of surgery, 24 and 48 hours postoperatively.|preoperatively, end of surgery, 24 and 48 hours postoperatively|For an effect size of 0.20 assuming a two-sided error type I error of 0.05 and a power of 0.80, a sample size of 60 sixty patients (30 patients in each group) would be required.|||U/L||Standard Deviation|Mean
1431191|NCT01000493|Secondary|Change From Baseline in MSFQ Items (Diminished/Absent Libido; Arousal Difficulties; Orgasm Difficulties/Anorgasmia and Degree of Sexual Satisfaction) Scores|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent). The areas of sexual functioning included were diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia and degree of sexual satisfaction. A follow-up version of the questionnaire includes an additional sixth item of the participant’s global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|All subject population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431192|NCT01000493|Secondary|Change From Baseline in MSFQ Total Score in Females|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent with total score 5-30; higher score indicating more dysfunction). The areas of sexual functioning included were total score used as a global measure of sexual dysfunction. A follow-up version of the questionnaire includes an additional sixth item of the participant’s global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|Female participants from all subject population used. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431193|NCT01000493|Secondary|Change From Baseline in Massachusetts Sexual Function Questionnaire (MSFQ) Total Score and Erectile Dysfunction Score in Males|The MSFQ was derived from the Guided Interview Questionnaire for males and from the Arizona Sexual Experience Scale. The questionnaire includes five items with a score ranging from 1-6 (1: greater than normal; 2: normal; 3: minimally diminished; 4: moderately diminished; 5: markedly diminished and 6: totally absent with total score 5-30; higher score indicating more dysfunction). The areas of sexual functioning included were total score and erectile dysfunction (males only). A total score was used as a global measure of sexual dysfunction. A follow-up version of the questionnaire includes an additional sixth item of the participant’s global impression of improvement, with a score ranging from 1 to 6. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|Male participants from all subject population used. All subject population defined as participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431194|NCT01000493|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score, by Visit Week|The Massachusetts CPFQ was a brief self-report scale to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1: greater than normal, 2: normal, 3: minimally diminished, 4: moderately diminished, 5: markedly diminished and 6: totally absent functioning with total score 7-42; higher score indicating more dysfunction. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431195|NCT01000493|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAM-D), by Visit Week|The HAM-D was observer-rated depressive symptom rating scale to measure the severity of depressive symptoms in participants with primary depressive illness. The items were ranked on a scale of 0-4 (0: absent; 4: greatest severity) or 0-2 (0: no difficulty; 2: difficulty falling asleep). In addition to the total score (0-66; with higher score indicates more depression), the HAM-D anxiety factor score (sum of items 10, 11, 12, 13, 15 and 17) and the melancholia subscore (sum of items 1, 2, 7, 8, 10, and 13) of the 17-item HAM-D scale was analyzed. The melancholia subscale was derived from three formal psychometric criteria (calibration, ascending monotonicity and dispersion). It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1431196|NCT01000493|Secondary|Change From Baseline in the CAPS Recurrent Distressing Dreams Item (B2) at Weeks 1, 4, 8, and 12|The B2 asked participant about ‘Have you ever had unpleasant dreams about the event(s)? How often in the past month?’ Both frequency (0: never; 4: daily or all the time) and ‘at their worst, how much distress or discomfort did these dreams cause you? Did these dreams wake you up? [If yes, ask:] What were you feeling or doing when you awoke? How long does it usually take to get back to sleep? [Listen for report of panic symptoms, yelling, posturing] intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The total score 0-8, higher scores means more severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431301|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431197|NCT01000493|Secondary|Change From Baseline in the PSQI Addendum for PTSD (PSQI-A) Global Score, by Visit Week|The PSQI-A was self-report instrument to assess disruptive nocturnal behavior (DNB) in PTSD participants with 7 types of DNB. These items include frequency of 1: hot flashes, 2: general nervousness, 3: memories or nightmares of traumatic experience, 4: severe anxiety or panic, not related to traumatic memories, 5: bad dreams, not related to traumatic memories, 6: episodes of terror or screaming during sleep without fully awakening and 7: episodes of acting out dreams, such as kicking, punching, running, or screaming. Each item was rated on a scale (0: not in the past month, 1: less than once a week, 2: once or twice a week and 3: three or more times a week) with global score range of 0-21. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431198|NCT01000493|Secondary|Change From Baseline in the Pittsburgh Sleep Quality Index (PSQI) Global Score, by Visit Week|The PSQI was a self-rated questionnaire to assess sleep quality and disturbances. Individual items (19) generate 7-component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. The global score generated by addition of individual score excluding use of sleeping medication component. It contains 15 objective (about frequency of sleep disturbances and subjective sleep quality) and 4 subjective (typical bedtime, wake-up time, sleep latency and sleep duration) items with score range from 0: no to 3: severe difficulty. The PSQI Global Score ranges from 0 to 21 and a global score > 5 was suggestive of significant sleep disturbance. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431199|NCT01000493|Secondary|Change From Baseline in the DTS Cluster Sub Score|This instrument consists of 17 items which parallel the DSM criteria for PTSD. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem; 4: extreme, incapacitating) rated using 5-point scale and added to get total score. There were 8 items including guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment. The DTS cluster includes intrusion (items 1-4, 17 [score 0-40]), A/N (items 5-11 [score 0-56]) and hyperarousal (items 12-16 [score 0-40]) with lower score indicates less symptoms and higher scores means more severity, <20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and >80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431200|NCT01000493|Secondary|Change From Baseline in the Self-rated Davidson Trauma Scale (DTS), by Visit Week|This instrument consists of 17 items which parallel the DSM criteria for PTSD. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) rated using 5-point scale. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The DTS cluster includes intrusion (items 1-4, 17 [score 0-40]), avoidance/numbing (A/N; items 5-11 [score 0-56]) and hyperarousal (items 12-16 [score 0-40]). The total score (0-136) was added, lower score indicates less symptoms and higher scores means more severity, <20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431201|NCT01000493|Secondary|Change From Baseline in the Short PTSD Rating Review (SPRINT), by Visit Week|The SPRINT consists of 8 items that assess the core symptoms of PTSD, as well as related aspects of somatic malaise, stress vulnerability and functional impairment. Each item was rated on a 5 point scale (0: not at all, 1: a little bit, 2: moderately, 3: quiet a lot and 4: very much), total score 0-32; with higher scores means more severity. Also, it provided the information about how the participant feeling (as a percentage) and symptoms improved since beginning of treatment (rated on a 5 point scale [0: worse, 1: a no change, 2: minimally, 3: much and 4: very much]). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431202|NCT01000493|Secondary|Change From Baseline in the CGI-S Score, by Visit Week|The severity of illness items were rated on a 1-7 scale with 0 means not assessed (1: normal, not at all ill, 2: borderline mentally ill, 3: mildly ill, 4: moderately ill, 5: markedly ill, 6: severely ill, 7: among the most extremely ill participants). For the severity of illness item, the clinician indicated his/her assessment of the participant severity of illness considering their total clinical experience with the particular population being studied. It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1431231|NCT01000311|Secondary|Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.|||Percentage of subjects||95% Confidence Interval|Number
1431203|NCT01000493|Secondary|Percentage of Participants Responding, Based on a Clinical Global Impression- Global Improvement (CGI-I) Score of 1 or 2, by Visit Week|The global improvement items were rated on a 1-7 scale with 0 means not assessed (1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse). For the global improvement item, the clinician indicated their assessment of the participant’s total improvement or worsening compared with that individual's condition at the start of the study (the Baseline visit) whether or not the change was judged to be due to drug treatment. Responder was defined as a participant who had a CGI-I score of 1 or 2 (‘very much improved’ or ‘much improved’). It was assessed at Baseline, Week 1, 2, 4, 6, 8, 10 and 12. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1431204|NCT01000493|Secondary|Change From Baseline in the CAPS Hyperarousal Subscale Cluster Score at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed DSM-IV diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of hyperarousal). The re-experiencing subscale cluster score was derived from the CAPS. The possible range is 5 to 25 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1431205|NCT01000493|Secondary|Change From Baseline in the CAPS Avoidance/Numbing (A/N) Subscale Cluster Score at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed DSM-IV diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of A/N). The re-experiencing subscale cluster score was derived from the CAPS. The possible range is 7 to 35 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1431206|NCT01000493|Secondary|Change From Baseline in the CAPS Re-experiencing Subscale Cluster Score at Weeks 1, 4, 8 and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS assessed Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for PTSD, including criteria B-D (core symptom clusters of re-experiencing). The re-experiencing subscale cluster score was derived from the CAPS. The possible range was 5 to 25 with lower score indicates less severe symptoms and with a greater score indicating greater PTSD symptom severity. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and up to Week 12|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1431207|NCT01000493|Secondary|Percentage of Participants Remitting, Based on a CAPS Total Score < 20 at Weeks 1, 4, 8, and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. Remitter defined as a participants who has a CAPS total score <20. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Up to Week 12|ITT population. Only those participants available at the specified time points were analyzed. The analysis method was logistic regression adjusted for Baseline CAPS total score. At a visit where there were no remitters, no analysis was performed.|||Percentage of participants|||Number
1431208|NCT01000493|Secondary|Change From Baseline in the 17-item CAPS Total Severity Score at Weeks 1, 4, and 8|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and Week 1, 4, 8|ITT population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
1431220|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event is any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or was a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Up to Year 20.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study.|||Subjects|||Number
1431209|NCT01000493|Secondary|The Time to (Maintained) Clinical Response in Each Participants|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The time required to maintain CAPS response has been summarized.|Up to Week 12|ITT Population. Only those participants available at the indicated time points were analyzed.|||Days||Inter-Quartile Range|Median
1431210|NCT01000493|Secondary|Percentage of Participants Responding, Based on More Than Equal to (>=) 30 Percent (%) Reduction From Baseline in CAPS Total Severity Score at Weeks 1, 4, 8 and 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. Percentage of participants were calculated by total number of responders divided by number of participants assessed multiplied by 100.|Baseline (Day 1 pre-dose) and up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1431211|NCT01000493|Primary|Change From Baseline in the 17-item Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) Total Severity Score at Week 12|The CAPS was a 30-item clinical interview. Both frequency (0: never; 4: daily or all the time) and intensity (0: none or no problem with symptoms; 4: extreme, incapacitating) ratings were made on a 5-point scale. The CAPS total severity score was based on the 17 items that assess the frequency and intensity of PTSD symptoms. There were 8 items assessing associated features (guilt, hopelessness, memory impairment, overall response validity, global PTSD severity, global improvement and social and occupational impairment). The total score 0-136, higher scores means more severity, < 20: few symptoms or being asymptomatic, 20-39: mild or subthreshold PTSD, 40-59: threshold and moderate PTSD, 60-79: severe PTSD symptoms and > 80: extreme PTSD symptoms. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as value on Day 1 (pre-dose).|Baseline (Day 1 pre-dose) and Week 12|ITT population, consisted of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1431212|NCT01000480|Secondary|Number of Participants With an Objective Tumor Response|Participants with confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria, as well as participants with a not evaluable/tumor response unknown. CR: disappearance of all tumor lesions. PR: either a) at least a 30% decrease in sum of longest diameter (LD) of target lesions taking as a reference baseline sum LDs, or b) complete disappearance of target lesions, with persistence (not worsening) of 1 or more nontarget lesions. In either case, no new lesions appeared. SD: small changes that did not meet above criteria. PD: at least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.|Date of first dose through end of follow-up [up to 30 weeks (1 cycle=21 days)]|Intent-to-treat population: Participants who received at least 1 dose of study drug (pemetrexed or cisplatin).|||participants|||Number
1431213|NCT01000480|Secondary|Overall Survival|Overall survival (OS) was the duration from enrollment to death due to any cause. Participants who were alive were censored at the last contact.|Date of first dose to date of death (up to 35.4 months)|Intent-to-treat population: participants who received at least 1 dose of study drug (pemetrexed or cisplatin). The number of participants censored was 45.|||months||95% Confidence Interval|Median
1431214|NCT01000480|Primary|1 Year Progression Free Survival|Progression free survival (PFS) was defined as the time from study enrollment to the first observation of progressive disease (PD) or death from any cause. For participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined PD or death, PFS was censored at the date of the last objective progression-free disease assessment prior to start of postdiscontinuation chemotherapy. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.|Date of first dose to date of objectively determined PD or death [every cycle up to 4 cycles and then every 3 months up to 1 year (1 cycle=21 days)]|Intent-to-treat population: participants who received at least 1 dose of either study drug (pemetrexed or cisplatin). The number of participants censored was 35.|||percentage of participants||95% Confidence Interval|Number
1431215|NCT01000376|Secondary|Safety of Eribulin Administered Alone or Coadministered With Oral Ketoconazole, as Measured by Number of Subjects With Adverse Events.||monitored throughout|||||||
1431216|NCT01000376|Primary|Mean (SD) Area Under Concentration Time Curve From Zero to Infinity (AUC 0-oo) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had AUC (0-oo) data.|||ng*hr/mL||Standard Deviation|Mean
1431217|NCT01000376|Primary|Mean (SD) Maximum Observed Concentration (Cmax) of Eribulin||7 days after dosing on Days 1 and 15|Pharmacokinetic Population: includes all participants in this crossover study who completed PK evaluations and who had Cmax data.|||ng*mL||Standard Deviation|Mean
1431218|NCT01000337|Secondary|Transaminases||February 2011|||||||
1431221|NCT01000324|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study|||Subjects|||Number
1431222|NCT01000324|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0 to 30) period after administration of the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study|||Subjects|||Number
1431223|NCT01000324|Secondary|Anti-hepatitis B Virus (Anti-HBs) Antibody Concentration|Concentrations are given as Geometric Mean Concentrations (GMCs) expressed as mIU/mL.|At Year 18, 14 days and 30 days post challenge dose (Year 19)|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1431224|NCT01000324|Secondary|Number of Subjects With Immune Response to the Challenge Vaccine Antigen|None of the subjects received a challenge dose at Years 16, 17, 18 and 20 while, one subject received the challenge dose at Year 19.|Before, 14 days and one month after the challenge dose at Year 19.|The analysis was performed on LT Total cohort that included all subjects who returned at each annual time point and who belonged to the Total Vaccinated cohort in the primary study|||Subjects|||Number
1431225|NCT01000324|Primary|Anti-HAV and Anti-HBs Geometric Mean Concentrations (GMCs)|Concentrations were expressed as GMCs in mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity.They were included in the ATP analysis for the primary study, did not receive hepatitis A or B vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.|||milli-international units per milliliter||95% Confidence Interval|Geometric Mean
1431226|NCT01000324|Primary|Number of Subjects Seropositive for Anti-hepatitis A Virus Antibodies (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies and With Anti-HBs Antibody Concentrations >= 10 Milliinternational Units Per Milliliter (mIU/mL).|Seropositivity for anti-HAV antibodies is defined as antibody concentrations >= 15 milliinternational units per milliliter (mIU/mL). Seropositivity for anti-HBs antibodies is defined as antibody concentrations >= 6.2 mIU/mL.|At Years 16, 17, 18, 19 and 20.|The analysis was performed on the Long-Term (LT) According-to-Protocol (ATP) cohort for analysis of immunogenicity. They were included in the ATP analysis for the primary study, did not receive hepatitis A or B (hep A/B) vaccination that was not specified in the protocol and were not eliminated for abnormal increase of antibody concentrations.|||Subjects|||Number
1431227|NCT01000311|Secondary|Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations|"Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination.~Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine."|From day 1 to 18 months|Analysis was performed on the safety dataset, i.e. all subjects in the exposed population who provided postbaseline safety data|||Number of subjects|||Number
1431228|NCT01000311|Secondary|Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.|One month after MenACWY-CRM toddler vaccination|Analysis was performed on the PP toddler dataset for MenACWY-CRM.|||Percentage of subjects||95% Confidence Interval|Number
1431229|NCT01000311|Secondary|Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.|||Titers||95% Confidence Interval|Geometric Mean
1431230|NCT01000311|Secondary|Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination|The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.|Baseline and Six months after third infant dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM.|||Percentage of subjects||95% Confidence Interval|Number
1431569|NCT00997516|Secondary|Deep Space Infection|Number of participants who required reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses were classified as deep space infections.|6 months||||participants|||Number
1431232|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone|Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.|One month after PCV toddler vaccination|Analysis was performed on the PP pneumococcal toddler population.|||μg/mL||95% Confidence Interval|Geometric Mean
1431233|NCT01000311|Secondary|Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.|One month after third dose of routine infant series vaccination|Analysis was performed on the PP datasets of infants for concomitant, pertussis and hepatitis B vaccinations|||μg/mL||95% Confidence Interval|Geometric Mean
1431234|NCT01000311|Secondary|Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone|"The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.~The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age."|One month after third dose of routine infant series vaccination|Analysis was performed on the PP concomitant, pertussis and hepatitis B infant populations.|||Percentage of subjects||95% Confidence Interval|Number
1431235|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.|||Titers||95% Confidence Interval|Geometric Mean
1431236|NCT01000311|Secondary|Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age.~Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM."|Baseline and one month after third infant dose of MenACWY-CRM|Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.|||Percentage of subjects||95% Confidence Interval|Number
1431237|NCT01000311|Secondary|hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was performed on the PP toddler dataset for MenACWY-CRM vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1431238|NCT01000311|Primary|Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM|"Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.~The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A."|Baseline and one month after fourth-dose of MenACWY-CRM|Analysis was done on the per-protocol (PP) toddler dataset for MenACWY-CRM, i.e. the subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to database lock.|||Percentage of subjects||95% Confidence Interval|Number
1431239|NCT01000285|Secondary|Effects of HTLV-1 Integration Sites After Treatment||6 months||||number of integration sites||Standard Error|Mean
1431240|NCT01000285|Secondary|Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence||6 months||||percentage of nucleotide divergence||Standard Error|Mean
1431241|NCT01000285|Secondary|Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA||6 months||||copies/peripheral blood mononuclear cell||Standard Error|Mean
1431242|NCT01000285|Secondary|Relation of NFκB Gene Expression Profile on Response|Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated.|6 months|Average RPKM values normalized to Patient A before therapy.|||fold expression||Standard Error|Mean
1431243|NCT01000285|Secondary|Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads||6 months||||copies/peripheral blood mononuclear cell||Standard Error|Mean
1431244|NCT01000285|Secondary|Time to Progression|-The progression definitions used for this study are from the 2007 Cheson criteria.|Up to 4 years following completion of therapy|12 out of the 18 participants had a complete or partial response.|||days||Full Range|Median
1431245|NCT01000285|Primary|Efficacy of Treatment as Measured by Best Overall Response|-The response definitions used for this study are the 2007 Cheson criteria.|Up to 4 years following completion of therapy||||participants|||Number
1431249|NCT01000155|Primary|Percent Fetal Hemoglobin (HbF%) Induction Success Rate|Success will be defined by comparing the maximum HbF% on study drug to the HbF% at baseline. An absolute increase in HbF% of 4% of more, or an increase to 100% or more of baseline in patients with HbF under 4% at baseline will be considered a success. HbF% induction success rate is calculated as the count of successes divided by the count of patients in the analysis population.|HbF% was measured at baseline and weekly on treatment. Median duration of treatment was 3 months.|The analysis dataset is comprised of all treated patients.|||proportion of patients||90% Confidence Interval|Number
1431250|NCT01000064|Secondary|The Study Will Utilize fMRI Methods (as Well as Aforementioned Neurobehavioral Measures) to Elucidate Neural Mechanisms of Response.||12 weeks|Based on the analysis of neurobehavioral assessment data, complications with screening, and limited sample size, the neural mechanisms of response to Vyvanse vs placebo were not significant enough to be measured and compared by fMRI. There is no data from the fMRI to be reported because it was abandoned as an aspect of this study before analysis.||||||
1431251|NCT01000064|Secondary|Evaluation of Which Types of Patients Are Most Likely to Benefit From Treatment||12 weeks|No data were collected.||||||
1431252|NCT01000064|Primary|"Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Behaviour Rating Inventory of Executive Function-Adult Version (BRIEF-A) Organization of Materials Sub-scale."|"The BRIEF-A is a standardized rating scale developed to observe everyday behaviors associated with specific domains of the executive functions in adults ages 18 to 90 years. The Organization of Materials scale measures orderliness of work, living, and storage spaces.~T-scores (M = 50, SD = 10) are used to interpret the individual’s level of executive functioning on the BRIEF-A, with higher scores indicating more difficulty in a particular area."|12 weeks||||t-scores||Standard Deviation|Mean
1431253|NCT01000064|Primary|"Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Conners Adult ADHD Rating Scale: Long Form (CAARS:L) Inattention/Memory Problems Sub-scale."|"The CAARS:L is an assessment tool that prompts an observer to provide valuable information about the client. This instrument is helpful when considering a diagnosis of ADHD or related problem. High scores on the Inattention/Memory Problems sub-scale may indicate difficulty in concentration, difficulty planning or completing tasks, forgetfulness, absent-mindedness, and/or being disorganized.~T-scores (M = 50, SD = 10) are used to measure ratings with higher t-scores indicating greater inattention and memory problems. When a t-score is around 60, this indicates greater risk."|12 weeks||||t-scores||Standard Deviation|Mean
1431254|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using the Wechsler Adult Intelligence Scale -- Fourth Edition (WAIS-IV) Digit Span-Backward Subtest.|Digit Span repeats strings of digits of increasing length said by the examiner in the same (forward) and in reverse (backward) order. It measures working memory and concentration with a range of scaled scores from 1-19, with higher scaled scores indicating better performance when compared to population norms.|12 weeks||||units on a scale||Standard Deviation|Mean
1431255|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Standard Error (SE) measures inattention. Consistency of response times is measured by the standard error for responses to targets. Higher values indicate a greater amount of inattention."|12 weeks||||ms||Standard Deviation|Mean
1431256|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II)|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Inter-Stimulus Interval (ISI) Change assesses the ability to adapt to changing inter-stimulus intervals. Inter-stimulus intervals refers to the amount of time between presentation of stimuli. High t-scores indicate that RT increased as the ISI increased; negative values indicate that RT decreased as the ISI increased.~Less Hit RT ISI Change indicates less variability in RT depending on the speed of presentation."|12 weeks||||t-scores||Standard Deviation|Mean
1431257|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Hit Reaction Time (RT) Block Change measures inattention and vigilance. Lower values indicate less slowing in RT as the test progressed. High T-scores indicate decreased vigilance over time."|12 weeks||||t-scores||Standard Deviation|Mean
1431258|NCT01000064|Primary|Assessment of Various Components of Attention, Related Cognitive Processes and ADHD Symptoms, Using Conners Continuous Performance Task (CPT-II).|"Conner's Continuous Performance Task (CPT-II) measure sustained attention and response inhibition.~CPT-II Preservations represent responses in which reaction time was less than 100 ms; these responses are assumed to be anticipatory, random, or slow/inattentive (i.e., carried over from the previous response) because it is physiologically impossible to respond accurately in so short a time. Higher T-scores, percentiles, and means indicate worse performance."|12 weeks||||ms||Standard Deviation|Mean
1431259|NCT01000025|Secondary|Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0|Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0|42 Months|As treated population|||participants|||Number
1431260|NCT01000025|Secondary|Objective Response Rate|Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.|42 months|ITT|||percentage of participants||95% Confidence Interval|Mean
1431261|NCT01000025|Secondary|Progression-free Survival|progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee|42 Months|ITT|||Months||95% Confidence Interval|Median
1431262|NCT01000025|Secondary|Overall Survival in EGFR-mutant Patients|Overall survival by EGFR-mutantion subgroups|42 Months|Patients with EGFR mutation|||Months||95% Confidence Interval|Median
1431263|NCT01000025|Secondary|Overall Survival in KRAS-WT Patients|Median and 95% confidence intervals of Overall survival in KRAS-WT patients|42 Months|Patients with K-Ras mutation wild type|||Months||95% Confidence Interval|Median
1431265|NCT00999921|Secondary|Number of Participants Analysed for Response of Cyclical Mastalgia (Good Response Was Defined as Disappearance of Mastalgia)|"All patients who had an increase in breast pain in the perimenstrual period were designated as having cyclical mastalgia. Response was assessed following treatment in terms of either persistence of cyclical mastalgia after 3 months of treatment or disappearance of cyclical mastalgia"|3 months|114 patients were identified as having cyclical mastalgia of whom 58 patients(37 fibroadenosis, 3 fibroadenonomas and 18 mastalgias with no lump) received Tamoxifen and 56 (36 fibroadenosis, 3 fibroadenomas and 17 mastalgias with no lump) received Evening Primrose Oil for 3 months. Good response was defined as disappearance of cyclical mastalgia.|||participants|||Number
1431266|NCT00999921|Primary|Number of Participants Analysed for Reduction in Mastalgia (Cardiff Breast Pain Score).|All patients were categorized as Grade 0 for no pain, grade 1 for mild pain, grade 2 for moderate pain, Grade 3 for severe pain. Therapeutic response to mastalgia was expressed in terms of Cardiff Breast Pain Score (CBS) where CBS I = excellent response with no pain, CBS II = substantial response, CBS III = poor response and CBS IV = no response|3 months|88 patients treated with Tamoxifen and 47 patients treated with Evening Primrose Oil were assessed for Cardiff Breast Pain Score. Patients with fibroadenomas and those with Grade 0 pain at the beginning of therapy were excluded from this analysis.|||participants|||Number
1431267|NCT00999921|Primary|Number of Participants Analysed for Reduction in Lump Size ( 60% Reduction in Lump Size Considered to be a Satisfactory Response)|Ultrasonography of the breast was used to ascertain the lump size at the beginning of therapy and a repeat Ultrasonography of breast was done after 3 months at the end of the proposed therapy to record the posttreatment lump size by the same operator. The difference between the two findings were recorded and noted and a 60% or more reduction in the size of the lump was considered as a satisfactory response.|3 months|102(out of 127) patients receiving Tamoxifen and 99(out of 129) receiving Evening Primrose Oil were assessed for reduction in lump size. The remaining patients had mastalgia with no lump, hence were excluded from this assessment. A 60% or more reduction in lump size after completion of the therapy was considered as a satisfactory response.|||participants|||Number
1431268|NCT00999908|Secondary|Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.|||Liters||Standard Deviation|Mean
1431269|NCT00999908|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.|4 hour period following inhalation of study treatment|Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.|||Liters||Standard Deviation|Mean
1431270|NCT00999908|Primary|Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.|4 hour period following inhalation of study treatment|Per protocol population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period and who were compliant with the protocol and without any major deviation likely to affect the analysis of pulmonary function measurements.|||Liters||Standard Deviation|Mean
1431271|NCT00999830|Secondary|Safety Assessment|Adverse Events, Serious Adverse Events, physical examination and biological changes.|from screening visit to the End of Study (at each study visit)||||participants|||Number
1431272|NCT00999830|Secondary|Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment|KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.|From the start up to the end of study (15 months)||||% of occupancy||Full Range|Median
1431273|NCT00999830|Primary|Rate of Patients Achieving a Response Based on M-protein or Free Light Chains|"Response was defined:~In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;~In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis~In patients with serum M-protein < 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (<0.26 or > 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels."|From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices||||participants|||Number
1431274|NCT00999804|Secondary|Clinical Response||12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participants were not evaluable for efficacy.|||participants|||Number
1431275|NCT00999804|Secondary|Total Pathologic Complete Response|pathologic complete response was defined as no residual invasive cancer in the breast and the axillary lymph nodes.|12 weeks or 24 weeks depending on arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.|||participants|||Number
1431276|NCT00999804|Secondary|Number of Participants With Adverse Events|the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy|12 week or 24 weeks depending on arm assignment|Participants who started the study treatment will be evaluable for safety analysis|||participants|||Number
1431277|NCT00999804|Primary|Pathologic Complete Response|"Pathologic complete response was defined as no residual invasive cancer in the breast, after 12 or 24 weeks of lapatinib/trastuzumab with or without endocrine therapy.~This outcome is based on patient's pathological report. We are not measuring the clinical response.~Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable."|12 or 24 week depending the arm assignment|Participants who have received at least one cycle of therapy (defined as one dose of trastuzumab and 21 days of lapatinib), and have had their response classified were evaluable. 4 participant were not evaluable: 3 participant were found ineligible for the study and one participant died before surgery.|||participants|||Number
1431278|NCT00999713|Secondary|Change in Oxygenation: Second Intervention|The Oxygenation Index after the second intervention (if applicable) is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.|48 hours after enrollment, up to 12 hours after each intervention|Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).|||index number||95% Confidence Interval|Geometric Mean
1431279|NCT00999713|Secondary|Change in Oxygenation: First Intervention|The Oxygenation Index after the first intervention is calculated as the fraction of inspired oxygen, in percent, times the mean airway pressure, in mmHg, divided by the partial pressure of oxygen in arterial blood, in mmHg. Lower values are better.|48 hours after enrollment, up to 12 hours after each intervention|Total number of subjects analyzed at each measurement fluctuates due to arterial blood gas testing not being ordered at the appropriate time (i.e., subjects missing a test at a specific time point since the frequency of these tests in this study are not standard of care).|||index number||95% Confidence Interval|Geometric Mean
1431280|NCT00999713|Secondary|Total Duration of Stay Required|Length of stay (LOS) ,measured in days, from admission to PICU discharge and admission to hospital discharge.|Admission to discharge, up to 120 days||||days||Inter-Quartile Range|Median
1431281|NCT00999713|Secondary|Ventilator Free Days (VFDs)|Number of days the patient is alive and off of the ventilator|60 days after study enrollment||||Days||Inter-Quartile Range|Median
1431282|NCT00999713|Primary|All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge|Overall mortality rate from admission to PICU discharge|Admission to PICU discharge, up to 120 days||||Participants|||Count of Participants
1431283|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 24.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 24|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.|||units on a scale||95% Confidence Interval|Mean
1431284|NCT00999687|Primary|Change From Baseline in Single-Hand Nail Psoriasis Severity Index (NAPSI)and in the Modified Target NAPSI for the Single Most Severely Affected Nail of Each Hand at Week 12.|The nail is divided by imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. The NAPSI score evaluates presence of signs in the nail bed (of onycholysis, splinter hemorrhages, nail bed discoloration, and subungual hyperkeratosis) and on the nail matrix (pitting, leukonychia, red spots in the lunula and nail plate crumbling) in all 10 fingernails, providing a minimal score of 0 and a maximum of 80. This study is an intra-patient side-to-side comparison, it measures nail disease on a single hand. All 5 fingers in each group were scored providing a maximum score of 40 and a minimal of 0. The modified target NAPSI score for the target nail scores severity of nail matrix and nail-bed psoriasis from 0 (no sign) to 3 (severe involvement) in each nail quadrant, providing a maximum score of 96 and a minimal of 0.|Baseline and Week 12|Higher values represent a worse outcome. For example, a higher score at baseline and a lower score after treatment represent an improvement.|||units on a scale||95% Confidence Interval|Mean
1431285|NCT00999661|Secondary|Change in Body Mass Index From Baseline to 24 Months|Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline.|Baseline to 24 months||||kilograms per meters squared||Standard Deviation|Mean
1431286|NCT00999661|Secondary|% Excess Weight Change From Baseline to 12 Months|Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 12 months|Intent to Treat Population|||percent of excess weight at baseline||Standard Deviation|Mean
1431287|NCT00999661|Primary|Percent Excess Weight Change From Baseline to 24 Months|Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.|Baseline to 24 months|Intent to Treat Population - All subjects implanted with gastric band and signing informed consent.|||percent of excess weight at baseline||Standard Deviation|Mean
1431288|NCT00999609|Secondary|Visual Acuity|Measurement of the sharpness of vision, determined by the ability to read letters on a standardized chart from a specified distance.|One year (change from baseline)||||LogMAR||Standard Error|Mean
1431289|NCT00999609|Secondary|Multi-luminance Mobility Testing (Monocular)|The MLMT measures changes in functional vision, as assessed by the ability to navigate a course accurately and at a reasonable pace at different levels of environmental illumination. MLMT was assessed using the first eye at 1 or more of 7 levels of illumination, ranging from 400 lux (a brightly lit office) to 1 lux (a moonless summer night). Each light level was assigned a score code ranging from 0 to 6. A higher score indicated that a subject was able to pass the MLMT at a lower light level. A score of -1 was assigned to those who could not pass MLMT at 400 lux. The MLMT of each subject was videotaped and assessed by independent graders. The MLMT score was determined by the lowest light level at which the subject was able to pass the MLMT. The MLMT score change was defined as the difference between the score at Baseline and the score at Year 1. A positive MLMT score change from Baseline to Year 1 visit indicated that the subject was able to complete the MLMT at a lower light level.|One year (change from baseline)||||Score Change in Light Levels||Standard Deviation|Mean
1431290|NCT00999609|Secondary|Full-field Light Sensitivity Threshold (FST) Testing: White Light|Measures the light sensitivity of the entire visual field by recording the luminance at which a subject reliably reports seeing the dimmest flash.|One year (change from baseline)||||log10(cd.s/(m^2))||Standard Error|Mean
1431291|NCT00999609|Primary|Multi-luminance Mobility Testing (MLMT), Bilateral|The MLMT measures changes in functional vision, as assessed by the ability to navigate a course accurately and at a reasonable pace at different levels of environmental illumination. MLMT was assessed using both eyes at 1 or more of 7 levels of illumination, ranging from 400 lux (a brightly lit office) to 1 lux (a moonless summer night). Each light level was assigned a score code ranging from 0 to 6. A higher score indicated that a subject was able to pass the MLMT at a lower light level. A score of -1 was assigned to those who could not pass MLMT at 400 lux. The MLMT of each subject was videotaped and assessed by independent graders. The MLMT score was determined by the lowest light level at which the subject was able to pass the MLMT. The MLMT score change was defined as the difference between the score at Baseline and the score at Year 1. A positive MLMT score change from Baseline to Year 1 visit indicated that the subject was able to complete the MLMT at a lower light level.|One year (change from baseline)||||Score Change in Light Levels||Standard Deviation|Mean
1431292|NCT00999596|Primary|FFDM (Full Field Digital Mammography) Mammogram Scores|6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.|Day 1|This was not a statistical sample per FDA FFDM Guideline. FDA Guideline specified that a minimum of 6 film sets from the participants be analyzed. The number of participants required by FDA changed mid-study.|||FFDM Mammogram set|||Number
1431293|NCT00999544|Secondary|Respiration Depression|Respiration rate measured over 60 seconds. Data were collected across multiple time points, but the peak minimum score was used for this outcome measure.|42 days|Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges.|||number of breaths per minute||Standard Deviation|Mean
1431294|NCT00999544|Primary|Abuse Liability Proxy|"Visual analog scale ratings (from 0-100) on the subject-rated measure of How much do you like the drug? with higher scores indicating greater abuse liability (and 100 anchored with extremely and zero indicating none anchored with none at all. Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure."|42 days|Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges. The within subject data analysis does not lend itself to reporting data in the format provided below.|||units on a scale (points 0-100)||Standard Deviation|Mean
1431295|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431296|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431297|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431298|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431299|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431300|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431302|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431303|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431304|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431305|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431306|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431307|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431308|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431309|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431310|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431311|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431312|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431313|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431314|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431315|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431316|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431317|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431318|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431319|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431320|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431321|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431322|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431323|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431324|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||10^6 cells/g||Full Range|Geometric Mean
1431325|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
1431326|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
1431327|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
1431328|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
1431329|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
1431330|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||Cell count/g||Full Range|Geometric Mean
1431331|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431332|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431333|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431334|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431335|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-13 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431336|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431337|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431338|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431339|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431340|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431341|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-10 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431342|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431343|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1446650|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)||Baseline up to Month 7||||percentage of participants|||Number
1431344|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431345|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431346|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431347|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-8 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431348|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431349|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431350|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431351|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431352|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431353|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-6 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431354|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431355|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431356|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431357|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1441655|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
1431358|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431359|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-5 – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431360|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431361|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431362|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431363|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431364|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431365|NCT00999466|Secondary|Sputum Cellularity and Cytokines, IL-1β – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431366|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431367|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Post Allergen Challenge||4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431368|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Pre Allergen Challenge||4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431369|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Post Allergen Challenge||1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431370|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Pre Allergen Challenge||1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431371|NCT00999466|Secondary|Sputum Cellularity and Cytokines, TNFα – Pre-treatment, Post Allergen Challenge||Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1441656|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
1431372|NCT00999466|Secondary|Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) – Pre-treatment, Pre Allergen Challenge||Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||pg/mL||Full Range|Geometric Mean
1431373|NCT00999466|Secondary|PC20 Methacholine Challenge – 4 Weeks After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
1431374|NCT00999466|Secondary|PC20 Methacholine Challenge – 4 Weeks After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|4 weeks after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
1431375|NCT00999466|Secondary|PC20 Methacholine Challenge – 1 Week After Last Dose, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
1431376|NCT00999466|Secondary|PC20 Methacholine Challenge – 1 Week After Last Dose, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|1 week after last dose, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
1431377|NCT00999466|Secondary|PC20 Methacholine Challenge – Pre-treatment, Post Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, post allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
1431378|NCT00999466|Secondary|PC20 Methacholine Challenge – Pre-treatment, Pre Allergen Challenge|PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1|Pre-treatment, pre allergen challenge|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||mg/mL||Full Range|Geometric Mean
1431379|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – 4 Weeks After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
1431380|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – 1 Week After Last Dose|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
1431381|NCT00999466|Secondary|FEV1, Early Asthmatic Response (EAR) – Pre-treatment|FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
1431382|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – 4 Weeks After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|4 weeks after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
1431383|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – 1 Week After Last Dose|FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|1 week after last dose|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
1441657|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
1431384|NCT00999466|Primary|FEV1, Late Asthmatic Response (LAR) – Pre-treatment|Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.|Pre-treatment (Baseline measurement)|There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.|||ratio||Standard Deviation|Mean
1431385|NCT00999167|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score|Changes from Baseline to Day 56 and the Final Visit were compared between treatment groups using an ANCOVA model for the total index RBANS score ). The index score is a sum of the scores for each of the 5 individual domains (immediate memory, visuospatial/constructional, language, attention). The minimum and maximum total index scores are 40 and 160, respectively; a higher score is better.|Day 56, Final Visit (D112)|Intent to treat (ITT)|||units on a scale||Standard Error|Least Squares Mean
1431386|NCT00999167|Secondary|Time to Meeting the Primary Endpoint|Secondary efficacy endpoint. The time to the first HE episode during the treatment period was calculated using the Kaplan-Meier method. Subjects who did not experience an HE episode were censored at the time of their last asterixis assessment. Subjects who had no post-randomization data for the primary endpoint were considered to have an HE episode at Day 1.|112 Days|Intent to treat (ITT)|||Days||95% Confidence Interval|Median
1431387|NCT00999167|Primary|Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0|"An HE event was defined as occurrences of either a West Haven (WH) Grade ≥2 or a WH Grade 1 and asterixis grade increase of 1 (if baseline WH = 0).~The WH criteria are widely used for rating the severity of HE and are summarized below:~Grade 1: trivial lack of awareness, euphoria or anxiety, shortened attention span, impaired performance of addition Grade 2: lethargy or apathy, minimal disorientation for time or place, subtle personality change, inappropriate behavior, impaired performance of subtraction Grade 3: somnolence to semi-stupor but responsive to verbal stimuli, confusion, gross disorientation Grade 4: coma (unresponsive to verbal or noxious stimuli)~Asterixis was assessed after arm and forearm extension along with wrist dorsiflexion for 30 seconds and assigned a grade according to the following criteria:~Grade 1: rare flaps Grade 2: occasional irregular flaps Grade 3: frequent flaps Grade 4: continuous flaps"|Part B: 112 Days|Intent to Treat (ITT)|||participants|||Number
1431388|NCT00999167|Secondary|Total Number of HE Events|Secondary efficacy endpoint. The total number of HE events during the treatment phase for subjects in the placebo and active arms.|112 Days|Intent to treat (ITT)|||HE event|||Number
1431389|NCT00999167|Primary|Part A: The Rate of AEs and Tolerability of HPN-100|Part A: The rate of AEs and tolerability of 6 mL and 9 mL doses of HPN-100 were considered the primary safety endpoints for Part A. Safety assessments included adverse events, laboratory tests (including ammonia, hematology, coagulation, liver function and serum chemistry parameters), vital signs, physical and neurological examinations, and electrocardiograms.|Part A: 28 days|Safety population|||Subjects|||Number
1431390|NCT00999141|Primary|Number of AEs Related to the Investigational Product (FS VH S/D 4 S-apr)||Day 0 (day of surgery) through postoperative Day 14|Safety Analysis Set|||Events|||Number
1431391|NCT00999141|Other Pre-specified|Total Aspiration Volumes From Hematomas and Seromas||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||mL||Full Range|Median
1431392|NCT00999141|Other Pre-specified|Investigators’ Confidence in Decreased Postsurgical Complications With the Use of FS VH S/D 4 S-apr||Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431393|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Treatment|During postoperative visits investigators recorded their satisfaction with treatment on each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431394|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Rate of Healing|During postoperative visits investigators recorded their satisfaction with the rate of healing of each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431395|NCT00999141|Other Pre-specified|Investigators' Satisfaction With Quality of Flap Adherence|During postoperative visits investigators recorded their satisfaction with the quality of flap adherence for each side of the face (FS VH S/D 4 s-apr (FS) or Standard of Care (SoC) sides of face)|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431396|NCT00999141|Other Pre-specified|Investigator Preference for Side of Face|Investigator reported outcomes data was collected for overall preference for 1 side of face|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431397|NCT00999141|Other Pre-specified|Participants' Assessment of Difference in Numbness Between Two Sides of Face|"During each postoperative visit (Day 1, 3, 7, and 14), participants were asked:~How would you rate your numbness on each side of your face on a scale of 0-10, with 10 being the worst numbness possible?~Difference in scores on a scale = (SoC score) - (FS VH S/D 4 s-apr score)~The planned and approved Statistical Analysis Plan (SAP) called for a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Scores on a scale||Standard Deviation|Mean
1431398|NCT00999141|Secondary|Reasons for Participants’ Preferences for Side of Face|"Participants responded to the following questions during the side of face preference assessment:~Which side of the face do you prefer? Left side, right side, or no preference?~If right or left is chosen, participants were asked Please mark ALL reasons for choosing this side~Better skin sensation~Less numbness~Looks better~Less bruising~Less swelling~Less pain~Less itching~Less tingling~Less feeling of pins and needles~Other ________________ (Free Text)"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Participants|||Number
1431399|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 14|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
1431400|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 7|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
1431401|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 3|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
1431402|NCT00999141|Secondary|Proportion of Participants Preferring Either FS VH S/D 4 S-apr or SoC Side of Face - Day 1|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants|||Proportion of Participants|||Number
1431403|NCT00999141|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4) on Postoperative Days 1, 3, 7, 14|"Participants responded to the following question during the side of face preference assessment:~“Which side of the face do you prefer? Left side, right side, or no preference?”"|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431404|NCT00999141|Secondary|Change From Baseline (Day 0, Preoperative) in Skin Sensitivity on Postoperative Days 3, 7, 14|Skin sensitivity was measured using Semmes-Weinstein Monofilament set to detect neurological damage. Filament sizes are noted by handle numbers of measuring tools ([handle number = log10(10*force in milligrams applied to skin)], range = 1.65 to 6.65). Detection of filament with smaller handle number = greater skin sensitivity. Smaller change in filament size detection from pre-op to post-op = less impact to recovery of sensation. Smallest filament felt for each side of face was noted. Change in skin sensitivity computed as (Handle Number Postop Day 3, 7, or 14) - (Handle Number Preop Day 0).|Day 0 (preoperative) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||Handle number(s)||95% Confidence Interval|Mean
1431405|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 14|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431406|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 7|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 7|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431407|NCT00999141|Secondary|Investigators' Visual Comparisons of Edema Between the 2 Sides of Face at Day 3|Investigators' assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 3|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431408|NCT00999141|Secondary|Investigators’ Visual Comparisons of Edema Between the 2 Sides of Face at Day 1|Investigators’ assessed which side of the face (FS VH S/D 4 s-apr or Standard SoC) had less edema|Through postoperative Day 1|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431409|NCT00999141|Secondary|Number of Participants With Hematoma/Seroma Anytime During the Study||Day 0 (day of surgery) through postoperative Day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431410|NCT00999141|Secondary|Participants With Hematoma/Seroma by Study Day|Investigators assessed each side of the face for the presence of hematoma and/or seroma|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431411|NCT00999141|Secondary|Participants' First Occurrence of Hematoma or Seroma by Study Day|Investigators assessed each side of the face for the presence of hematomas and/or seromas|Day 0 (day of surgery) through postoperative day 14|Full Analysis Data Set = All randomized and treated participants|||participants|||Number
1431412|NCT00999141|Primary|Total Volume of Drainage on Each Side of the Face|Total drainage volume collected from each side of the face. One side of face is treated with FS VH S/D 4 s-apr (FS); the other side is treated using standard of care (SoC).|24 hours (± 4h) after surgery|Full Analysis Data Set = All randomized and treated participants|||mL||Full Range|Median
1431413|NCT00999037|Secondary|Serum Phosphate Concentration|Change in serum phosphate at 12 weeks from baseline|12 weeks||||percent change from baseline||Standard Deviation|Mean
1431414|NCT00999037|Secondary|1,25(OH)2vitamin D Value|Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.|12 week||||percent change from baseline||Standard Deviation|Mean
1431415|NCT00999037|Primary|Change in FGF-23 Level|Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.|12 weeks||||percentage change from baseline||Standard Deviation|Mean
1431416|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT3 participant treated with 800 mg grazoprevir, who discontinued, and all GT1 participants were excluded from analysis.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
1431428|NCT00998868|Primary|Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography|All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment||||participants|||Number
1431417|NCT00998985|Secondary|Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo|Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.|Baseline and up to approximately 2 months|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. One GT1 participant treated with 50 mg grazoprevir, who discontinued, and all GT3 participants treated with grazoprevir were excluded from analysis.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
1431418|NCT00998985|Secondary|24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.|Day 7 at 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.|||nM||90% Confidence Interval|Geometric Mean
1431419|NCT00998985|Secondary|Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7|Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.|Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that these data will exhibit the effects of treatment, according to the underlying scientific model. GT1 or GT3 participants who received the same treatment were combined into a single arm. Participants with placebo were not analyzed as they did not receive grazoprevir.|||uM.hr||90% Confidence Interval|Geometric Mean
1431420|NCT00998985|Primary|Number of Participants With Clinical and Laboratory Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)|All participants who received at least one dose of the investigational drug according to the treatment(s) they actually received. Participants with either GT1 or GT3 who received the same treatment were combined for the summary into a single GT1 and GT3 arm.|||Participants|||Number
1431421|NCT00998881|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
1431422|NCT00998881|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0–2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0–2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0–2h for Postprandial Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*h / dL||Standard Error|Least Squares Mean
1431423|NCT00998881|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
1431424|NCT00998881|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|12 weeks|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||Percent||Standard Error|Least Squares Mean
1431425|NCT00998868|Secondary|Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System|"Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group.~MRC scale:~Grade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement."|within one month after enrollment||||Units on a scale (minimum 0, maximum 5)||Standard Deviation|Mean
1431426|NCT00998868|Secondary|Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination|The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.|within one month after enrollment||||participants|||Number
1431427|NCT00998868|Secondary|Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography|All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.|within one month after enrollment||||participants|||Number
1431429|NCT00998764|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431430|NCT00998764|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. The MMSE total score can range from 0 to 30, with lower scores indicating a greater degree of impairment. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 6, 19, 32, 45 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431431|NCT00998764|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431432|NCT00998764|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/ aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/ indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). The NPI total score ranges from 0 to 144 with higher NPI scores indicate greater impairment. A negative change indicates improvement from baseline.|Base Study Baseline, Weeks 26, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431433|NCT00998764|Secondary|Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on scale||Standard Error|Least Squares Mean
1431434|NCT00998764|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in AD participants. The DAD is administered to the participant’s caregiver in the form of an interview. The performance of basic activities of daily living is evaluated in 10 aspects including hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. The caregiver answers 40 questions as yes, no, or not applicable. A one-point score was assigned to each question if the answer is “yes” and a zero score was assigned if the answer is “no”. For questions answered as “not applicable”, no score will be assigned. The DAD total score was calculated as the total number of questions answered as “yes” divided by the total number of questions answered as “yes” or “no”, times 100. The DAD score can range from 0 to 100, with higher scores indicating better function. A positive change indicates improvement from baseline.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431465|NCT00998335|Secondary|Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||mg/dL||Standard Deviation|Mean
1431435|NCT00998764|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8)remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431436|NCT00998764|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4)constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8 remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Base Study Baseline, Weeks 13, 26, 39, 52 and 78|The Modified Intent-to-Treat (mITT) Population was defined as all randomly assigned participants who received investigational product in the base study, had a baseline for the base study, had at least one valid post-baseline assessment of the ADAS-Cog and DAD total score in the base study and signed informed consent in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431437|NCT00998764|Primary|Number of Participants Reporting a Serious Adverse Event|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|Safety population|||Number of Participants|||Number
1431438|NCT00998738|Secondary|Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy|Correlation coefficients will be produced relating the worst pain scores in the first cycle of therapy and the subsequent neuropathy scores as judged from the daily and weekly questions.|First cycle of therapy (up to 21 days)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431439|NCT00998738|Secondary|Severity of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.~The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431440|NCT00998738|Secondary|Incidence of the Acute Pain Syndrome (APS)|"APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.~The outcome measures for each subsequent cycle will be analyzed in a similar fashion."|Treatment initiation to day 21 (Cycle 1)|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431441|NCT00998738|Secondary|Toxicity Profile of CaMg Per CTCAE Active Version||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431442|NCT00998738|Secondary|Average Cumulative Ixabepilone Dose||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431443|NCT00998738|Secondary|Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431444|NCT00998738|Secondary|Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version|Time to onset of grade 2+ neurotoxicity was defined as time from randomization to the first occurrence of grade 2+ neurotoxicity. Time to onset of grade 3+ neurotoxicity was defined as time from randomization to the first occurrence of grade 3+ neurotoxicity.|Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431445|NCT00998738|Secondary|Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale||Up to 12 months from initiation of ixabepilone|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431446|NCT00998738|Primary|Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.|During the first 18 weeks of ixabepilone-based therapy|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
1431466|NCT00998335|Secondary|Metabolic Control as Measured by the Fasting Plasma Glucose Concentration||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||mg/dL||Standard Deviation|Mean
1431447|NCT00998660|Primary|Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.|Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.|3 months|The 93 implanted subjects accumulated 283.6 subject-months of follow-up through the 3-month visit. There were no reported user-related battery depletion adverse events that required an intervention by a health care professional and/or HCP designee.|||Event rate per 100 subject-months||95% Confidence Interval|Number
1431448|NCT00998582|Primary|Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease.|Change from baseline to 24 weeks|Large artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in large artery elasticity (mL/mmHg x10) from baseline to week 24|||ml/mmHg x10||Inter-Quartile Range|Median
1431449|NCT00998582|Primary|Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|Change from baseline to 24 weeks|Small artery elasticity was measured at baseline and week 24 in all participants. Outcome was change in small artery elasticity (mL/mmHg x100) from baseline to week 24|||ml/mmHg x100||Inter-Quartile Range|Median
1431450|NCT00998517|Secondary|Rates of Gain in Mid-upper Arm Circumference, and Length|These rates will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks||||mm/d||Standard Deviation|Mean
1431451|NCT00998517|Secondary|Remain Well-nourished Through 12 Months Following Successful Treatment for Moderate Acute Malnutrition (MAM)|Children who were successfully treated for MAM in the primary portion of the study were followed prospectively with scheduled follow-up visits for 12 months to evaluate whether they remained well-nourished, defined as mid-upper arm circumference (MUAC) >= 12.5 cm or weight-for-height Z-score >= -2 throughout the duration of follow-up.|12 months|Children who successfully recovered from MAM following the standard treat-to-WHZ -2 protocol.|||participants|||Number
1431452|NCT00998517|Secondary|Number of Patients With Fever, Cough, and Diarrhea During the First Two Weeks of Treatment||2 weeks||||participants|||Number
1431453|NCT00998517|Secondary|Number of Patients With Adverse Outcomes|This includes children with allergic or other adverse reactions that could be attributed to their assigned intervention food.|12 months||||participants|||Number
1431454|NCT00998517|Secondary|Rate of Weight Gain|This rate will be measured up to the 2nd followup visit (4 weeks) or up to the 1st followup visit (2 weeks) if the child recovered after only 2 weeks|4 weeks||||g/kg/d||Standard Deviation|Mean
1431455|NCT00998517|Primary|Number of Patients With Absence of Bilateral Pedal Pitting Edema||12 weeks or recovery||||participants|||Number
1431456|NCT00998517|Primary|Number of Participants With Nutritional Recovery|"Recovery is defined by weight for height Z (WHZ) score of -2 or greater using enrollment length.~WHZ will be computed using standard WHO growth standards: http://www.who.int/childgrowth/standards/en/"|12 weeks or upon completion of recovery||||participants|||Number
1431457|NCT00998426|Primary|Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection|All participants received GNS-POC, GS-POC and venous blood glucose measurements prior to and after HBIG injection( immediately following, 60 and 120 min post dose).|Pre-dose, immediately following, 60 min and 120 min after injection||||mg/dL||Standard Deviation|Mean
1431458|NCT00998374|Primary|Reactive Hypoglycemia Status|"Postoperative reactive hypoglycemia was defined as either~serum glucose <60 mg/dL at least 1 hour after initiation of glucose tolerance testing~serum glucose decrease ≥100 mg/dL within 1 hour after initiation of glucose tolerance testing"|6 months, 9 months, 12 months post-op||||participants|||Number
1431459|NCT00998374|Secondary|Subjective Symptoms of Hypoglycemia During Glucose Tolerance Testing|Subjective symptoms of hypoglycemia during glucose tolerance testing measured by patients’ responses to a questionnaire about symptoms of Weakness, Nausea, Hunger, Headache, Dizziness, Diaphoresis graded on a yes/no response|6, 9, and 12 months post-op||||participants|||Number
1431460|NCT00998374|Secondary|Insulin Resistance|Measured by levels of post prandial insulin|6, 9, and 12 months post-operatively||||pmol/L||Standard Deviation|Mean
1431461|NCT00998374|Primary|Mean Serum Glucose Levels|Serum glucose levels measured to assess reactive hypoglycemia status|30, 60, and 120 minutes at 6, 9, and 12 months post-operatively||||mg/dl||Standard Deviation|Mean
1431462|NCT00998335|Secondary|Percent Change From Baseline in Vascular Inflammatory Markers|Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM|3 and 6 months||||Percentage of change||Standard Deviation|Mean
1431463|NCT00998335|Secondary|Change in Anthropometric Measure (Body Mass Index [BMI]).|Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||Change from baseline (Kg/m2)||Standard Deviation|Mean
1431464|NCT00998335|Secondary|Advanced Lipid Testing|Change in lipoprotein particle number was determined using NMR.|3 and 6 months||||Change in number of particles (nmol/L)||Standard Deviation|Mean
1431524|NCT00997984|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||mmHg||Standard Deviation|Mean
1431467|NCT00998335|Secondary|Number of Hypoglycemic Events|Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial.|3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||Number of events|||Number
1431468|NCT00998335|Secondary|Change in Anthropometric Measure (Body Weight).|Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||Change from baseline (Kg)||Standard Deviation|Mean
1431469|NCT00998335|Secondary|Plasma Lipid Concentration.|Fasting plasma lipid concentration on day of admission at 3 and 6 months.|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||mg/dL||Standard Deviation|Mean
1431470|NCT00998335|Secondary|Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).|Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 for first 3 months and N=28 for 6 months"|||% of intramyocellular triglyceride||Standard Deviation|Mean
1431471|NCT00998335|Secondary|Change in Insulin Secretion|Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase).|3 and 6 months.|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms. N=30 at 3 months and N=28 at 6 months."|||ng/ml||Standard Deviation|Mean
1431472|NCT00998335|Secondary|Metabolic Control as Measured by the A1c||3 and 6 months|"All participants were started in the Insulin detemir only arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms."|||percentage of A1c||Standard Deviation|Mean
1431473|NCT00998335|Primary|Hepatic Steatosis|Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).|3 and 6 months|In six patients liver MRS was not possible due to claustrophobia, metal parts, or too large for MRI scanner. N=30 participants in the Insulin detemir x 3 months, N=8 participants in the Insulin Detemir alone and 22 in the Detemir Plus Aspart at 6 months.|||percentage of liver fat||Standard Deviation|Mean
1431474|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431475|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431476|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431477|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431478|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431479|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431480|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431481|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431482|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431483|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection|"Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431484|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431485|NCT00998309|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender|Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431486|NCT00998309|Primary|Number of Unlisted Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||Events|||Number
1431487|NCT00998309|Primary|Number of Participants With Treatment Related Adverse Events (TRAEs)|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|Baseline to 29 days|The safety analysis population consists of the cases that satisfy the paticipants conditions and in whom administration of this drug was confirmed.|||participants|||Number
1431488|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy|Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431489|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)|Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431490|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)|Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431491|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications|Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431492|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)|Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431493|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)|Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431494|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)|Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431495|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity|"Number of participants with responders of azithromycin to determine whether Infection severity, mild infection, moderate infection, or severe infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431525|NCT00997984|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||mmHg||Standard Deviation|Mean
1431570|NCT00997516|Secondary|Wound Infection|Number of participants who required additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis.|6 months||||participants|||Number
1431496|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection|"Number of participants with responders of azithromycin to determine whether type of infection, Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection, is significant risk factor."|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431497|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age|Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431498|NCT00998309|Secondary|Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender|Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431499|NCT00998309|Primary|Number of Participants With an Investigator’s Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.|The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.|Baseline to 29 days|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
1431500|NCT00998296|Secondary|Percentage Change in the Tumour Size From Baseline During the Expansion Phase|Percentage change in the tumour size from baseline is expressed as Number of subjects with maximum decrease from baseline in the sum of longest diameters of target lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||participants|||Number
1431501|NCT00998296|Secondary|Stable Disease for at Least 12 Weeks During the Expansion Phase|"SD: Neither sufficient shrinkage to qualify for PR (Partial response) nor sufficient increase to qualify for PD(Progressive disease), taking as references the smallest sum of diameters SoD while on study.~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||percentage of participants|||Number
1431502|NCT00998296|Secondary|Disease Control (DC) During the Expansion Phase|DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD. CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Other factors which add to the overall response of an imaging timepoint as PR are as below:- CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; SD for TL: change in the sum of diameters does not satisfy PR or PD. SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions.|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||percentage of participants|||Number
1431503|NCT00998296|Secondary|Objective Response (OR) During the Expansion Phase|"OR is defined as a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions.~CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be nonpathological in size (<10mm short axis). PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:~CR in TL, but non-CR/Non-PD in NTL leads to PR CR in TL, but not evaluated NTL leads to PR PR in TL, but non-PD NTL or not all evaluated NTL leads to PR; All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour assessment was to be performed at Screening, every 6 weeks after starting study treatment until disease progression, and at the end-of-treatment (EOT) visit (up to 1117 days)|Treated set|||percentage of participants|||Number
1431504|NCT00998296|Secondary|Trough Plasma Concentration of Afatinib at Steady State|"C(pre,ss) is defined as pre-dose (trough) concentration of afatinib in plasma at steady state immediately before administration of the next dose.~C24,7 corresponds to the plasma concentration at 24 hours on Day 7. C24,13 corresponds to the plasma concentration at 24 hours on Day 13. C24,27 corresponds to the plasma concentration at 24 hours on Day 27."|Day 7, Day 13, Day 15, Day 22, Day 27 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"|||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1431526|NCT00997984|Secondary|Change From Baseline in Mean Weiss Functional Impairment Rating Scale – Parent Report (WFIRS-P) Global Score at Week 8 - LOCF|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1431571|NCT00997516|Secondary|Length of Stay|Number of calendar days the participant was hospitalized.|up to 14 days||||Days||Standard Deviation|Mean
1431505|NCT00998296|Secondary|Cpre,ss,Norm (Dose Normalized Trough Plasma Concentration of Nintedanib at Steady State)|"Cpre,ss,norm (Dose normalized trough plasma concentration of nintedanib at steady state) are presented for the 2 MTD treatment groups (continuous administered nintedanib at 150 mg b.i.d. concomitantly with continuously administered afatinib 30 mg q.d. or with intermittently administered afatinib 40 mg q.d.)~As nintedanib is given twice daily, samples are taken at Day 8, Day 15, Day 22 and Day 28; the Pharmacokinetic (PK) parameter names will be Cpre,ss,15,norm (Day 8), Cpre,ss,29,norm (Day 15), Cpre,ss,43,norm (Day 22) and Cpre,ss,55,norm (Day 28)"|Day 8, Day 15, Day 22 and Day 28|"PKS. Only 6 patients were planned to be treated in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group. Nevertheless, the patients were allowed to reduce their dose and by the way they changed the group and came in the Nintedanib 150 mg +Afatinib 30 mg- Continuously group with at the end N = 8 evaluable concentrations instead of 6 planned"|||nanogram/millilitre/milligram (ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
1431506|NCT00998296|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|First treatment administration until cut-off date of 02 October 2014, up to 336 days|TS|||participants|||Number
1431507|NCT00998296|Secondary|Incidence and Intensity of Adverse Events According to CTCAE (Common Toxicity Criteria Adverse Event) Version 3.0|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First treatment administration until cut-off date of 02Oct2014; up to 336 days|TS|||participants|||Number
1431508|NCT00998296|Secondary|Overall Tumour Response Rate Assessed by the Investigator According to the Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1|"The investigator evaluated whether complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) occurred in a patient.~CR for target lesions: Disappearance of all target lesions. CR for non-target lesions: Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions"|6 weeks|TS|||percentage of participants|||Number
1431509|NCT00998296|Primary|Maximum Tolerated Dose (MTD) of Nintedanib and Afatinib Based on the Percentage of Participants Experienced Dose Limiting Toxicities|Maximum tolerated dose (MTD) of nintedanib and afatinib based on the Percentage of participants experienced dose limiting toxicities during the dose escalation phase.|first treatment cycle, up to 28 days|TS|||percentage of participants|||Number
1431510|NCT00998205|Secondary|Change in Early Transmitral Velocity/Early Lateral Mitral Velocity (E/E')|Echocardiography was performed at rest and with dobutamine stress at 3 minutes, 6 minutes, 9 minutes, and 12 minutes, to measure differences in E/E' at the septum and lateral mitral annulus. Change from baseline at recovery reported.|Baseline, recovery||||Ratio||Full Range|Mean
1431511|NCT00998205|Primary|Change in Left Ventricle Mean Diastolic Pressure|Left ventricle filling pressures were measured using a pigtail catheter inserted into the left ventricle. Measurements of left ventricle pressures were taken at baseline, 3 minutes, 6 minutes, 9 minutes, 12 minutes, and recovery. Change from baseline at recovery reported.|Baseline, recovery||||mmHg||Full Range|Mean
1431512|NCT00998049|Secondary|Rate of Failure to Mobilize|The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.|Duration of apheresis (up to 7 days)||||percentage of participants||95% Confidence Interval|Number
1431513|NCT00998049|Secondary|Time to Reach 6 Million CD34 Cells|Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.|Duration of apheresis (up to 7 days)||||days||95% Confidence Interval|Median
1431514|NCT00998049|Secondary|Median Number of Days of Apheresis||Duration of apheresis (up to 7 days)||||days||Full Range|Median
1431515|NCT00998049|Secondary|CD34 Yield Day 2|Number of CD34 cells/kg collected on day 2|Day 2||||cells/kg||Full Range|Median
1431516|NCT00998049|Secondary|CD34 Yield on Day 1|Number of CD34 cells/kg collected on day 1.|Day 1||||cells/kg||Full Range|Median
1431517|NCT00998049|Primary|Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis|"Number of CD34 cells/kg collected on days 1-2.~Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm."|After 2 days of apheresis||||participants|||Number
1431518|NCT00998023|Secondary|Major Complications|Number of participants with permanent access site-related nerve injury, access-site related surgical/vascular repair, amputation related to access closure complication, access site-related bleeding/hematoma requiring transfusion, any new ipsilateral lower extremity ischemia requiring non-surgical intervention, local access site-related or generalized infection requiring prolonged hospitalization or re-hospitalization and treatment with IV antibiotics or inflammatory reaction that may include local signs and drainage, treated with re-hospitalization, IV antibiotics and/or surgical intervention|1 Day|Per protocol|||Participants|||Number
1431519|NCT00998023|Primary|Mean Score on the Visual Analogue Scale|The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).|Immediately before vascular closure and immediately after vascular closure.|Per protocol|||Scores on a Scale||Standard Error|Mean
1431520|NCT00997984|Secondary|Change From Baseline in Weight at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||pounds||Standard Deviation|Mean
1431521|NCT00997984|Secondary|Change From Baseline in Height at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||inches||Standard Deviation|Mean
1431522|NCT00997984|Secondary|Change From Baseline in Oral Temperature at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||º F||Standard Deviation|Mean
1431523|NCT00997984|Secondary|Change From Baseline in Pulse Rate at Week 8 - LOCF||Baseline and up to 8 weeks|Safety Population|||beats per minute||Standard Deviation|Mean
1431528|NCT00997984|Secondary|Change From Baseline in the Bedtime Resistance Subscale of Child’s Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF|The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1431529|NCT00997984|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1431530|NCT00997984|Secondary|Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1431531|NCT00997984|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF|The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.|Baseline and up to 8 weeks|Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study.|||Units on a scale||Standard Error|Least Squares Mean
1431532|NCT00997984|Secondary|Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|FAS|||Percent of Participants|||Number
1431533|NCT00997984|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and up to 8 weeks|FAS|||Percent of Participants|||Number
1431534|NCT00997984|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 8 weeks|Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study.|||Units on a scale||Standard Error|Least Squares Mean
1431535|NCT00997932|Primary|IUD Expulsion|Expulsion of the LNG-IUS|From time of insertion to final study date which is 6 months after IUD insertion.||||Participants|||Count of Participants
1431536|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||48 weeks|||||||
1431537|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||24 weeks|||||||
1431538|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||48 weeks|||||||
1431539|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||24 weeks|||||||
1431540|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||48 weeks|||||||
1431541|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||48 weeks|||||||
1431542|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||24 weeks|||||||
1431543|NCT00997672|Secondary|Effect of Lithium on Quality of Life Will be Assessed With the EQ-5D Scale.||0 weeks|||||||
1431544|NCT00997672|Secondary|The Effect of Lithium on Mood Will be Explored With the Beck Depression Inventory.||0 weeks|||||||
1431545|NCT00997672|Secondary|Micro- and Macrostructural Magnetic Resonance Parameters Will be Compared Before and After Treatment. This Will Include Voxel Based Morphometry, Resting Functional MRI, Diffusion Tensor Imaging and MRI Spectroscopy.||0 weeks|||||||
1431546|NCT00997672|Secondary|Secondary Outcome Will be the Unified Multiple System Atrophy Rating Scale (UMSARS). Statistical Analysis Will be Performed to Compare the Effect of Treatment on Both Groups.||0 weeks|||||||
1431547|NCT00997672|Primary|Primary Endpoint of the Study Will be the Difference in Number and Relative Frequency of Severe Adverse Events (SAE) and Non Severe Adverse Events (nSAE) Recorded During the Study, Between Treatment and Placebo Group.|Number of Adverse Events and their relative frequency in treatment groups was analyzed|the endpoint will be recorded at all visits||||number of AEs|||Number
1431548|NCT00997620|Secondary|Nasal Symptom Scores|Total nasal symptom score was measured AM and PM. The reflective scale measures subjective symptoms over the previous 12 hours. Instantaneous symptoms measure how subjects felt at the present time. The score consists of subjective perception of nasal congestion, rhinorrhea, nasal itching and sneezing. The scale for each symptom is 0 - not present, 1- mild (present but minimal), 2 - moderate (symptoms are bothersome but tolerable), 3 - severe (symptoms are not tolerable). The baseline value was the mean of the 7 day placebo run-in for the combined scores. This was calculated for the placebo group and the fluticasone group for both the instantaneous and the reflective scores. The intervention time utilized the same combined AM and PM reflective and instantaneous scoring. The data was analyzed using two sample t test comparison of the placebo vs fluticasone furoate group. Low value, less symptoms. High value, more symptoms. Minimum score is 0. Maximum score is 24.|2 weeks||||units on a scale||Standard Deviation|Mean
1431572|NCT00997516|Secondary|Visceral or Vascular Injury|Number of participants who required intervention (suture or stapled repair, use of hemostatic agents) for injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection.|during surgery, up to 6 hours||||participants|||Number
1431549|NCT00997620|Secondary|Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire|In nocturnal rhinoconjunctivitis quality of life questionnaire instrument to measure the effects of nasal disorder on nighttime sleep and awakening. It consists of 16 questions. The scale is from 0-6, 0 being not troubled and 6 reflecting extreme trouble. This survey is interpreted as a minimal clinically important difference of each question. A change of +/- 0.5 is a threshold of minimally important clinical difference. Higher value mean more disturbance.|2 weeks|The NRQLQ values represent the average for each intervention.|||units on a scale||Standard Error|Mean
1431550|NCT00997620|Secondary|Change in Epworth Sleep Scale|The Epworth sleepiness scale measures is a validated test of daytime sleepiness which involved the subjects answering 8 questions. Each question is answered on a 0 - 3 scale with 3 being the most likely associated with drowsiness. The score is reported as a composite score of 8 questions, with a minimum score of 0 and a maximum score of 24. A higher composite score represents more likelihood of daytime sleepiness. It is administered between 1500 and 1700 daily.|Baseline and after 2 weeks intervention||||units on a scale||Standard Deviation|Mean
1431551|NCT00997620|Primary|Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.|The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.|over 2 weeks||||milliseconds||Standard Deviation|Mean
1431552|NCT00997620|Primary|Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.|The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.|after 2 weeks intervention||||non identified targets||Standard Deviation|Mean
1431553|NCT00997620|Primary|Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance|The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.|over 2 weeks||||number of errors||Standard Deviation|Mean
1431554|NCT00997594|Primary|Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation|Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.|1 week||||participants|||Number
1431555|NCT00997594|Primary|Serum Cathecholamine Levels||around one year||2015-10-31|10/2015||||
1431556|NCT00997594|Secondary|Increase in Cortisol||1 day|||||||
1431557|NCT00997594|Primary|Increase in Catecholamine||One day|||||||
1431558|NCT00997555|Secondary|Length of Hospital Stay|Number of hospital days (bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).|until discharge from hospital, data reviewed every 6 months||||days||95% Confidence Interval|Median
1431559|NCT00997555|Secondary|Length of ICU Stay|Number of ICU days (bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).|until discharge from hospital, data reviewed every 6 months||||days||95% Confidence Interval|Median
1431560|NCT00997555|Secondary|Length of Mechanical Ventilation|Days of mechanical ventilation (bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|until discharge from hospital, data reviewed every 6 months||||days||95% Confidence Interval|Median
1431561|NCT00997555|Secondary|Incidence of Pneumonia|Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)|until discharge from the hospital, data reviewed every 6 months||||participants|||Number
1431562|NCT00997555|Primary|Respiratory Associated Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months||||participants|||Number
1431563|NCT00997555|Primary|All Cause Mortality|Bronchoscopy group deaths n=0. Control group deaths n=1.|until death or discharge from hospital, data reviewed every 6 months||||participants|||Number
1431564|NCT00997516|Secondary|Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months.|"The Cosmetic Appearance Scale assessed the degree of satisfaction with the physical appearance of the abdomen (and its scars) using a visual analogue scale. Numeric scores were obtained by measuring the horizontal distance from the low end of the scale to the marking, and then normalized on a scale of 0-20 points. Higher scores indicate a higher degree of satisfaction.~Since your operation, how would you describe the overall appearance of your abdomen? (Revolting; Beautiful) Since your operation, how would you describe your incisional scars? (Revolting; Beautiful) How satisfied are you with your incisional scars? (Very unsatisfied; Very satisfied) How much discomfort do your incisional scars cause? (Severe, daily pain; No pain at all) Can you score your own incisional scar? (Worst possible scar; Best possible scar)"|6 months|Participants who returned surveys for long-term follow-up|||units on a scale||Standard Deviation|Mean
1431565|NCT00997516|Secondary|Body Image Score at 6 Months|"After a minimum of 6 months, a Body-Image Questionnaire was sent to participants. The questionnaire has 5 questions, with answers ranging from 1 (Extremely) to 4 (Not at all); lower scores indicate worse satisfaction with and perception of bodily appearance.~Are you less satisfied with our body since the operation? Do you think the operation has damaged your body? Do you feel less attractive as a results of your operation? Do you feel less feminine or masculine as a result of your operation? Is it difficult to look at yourself naked?"|6 months|67 of 75 patients completed and returned follow-up surveys|||units on a scale||Standard Deviation|Mean
1431566|NCT00997516|Secondary|Readmission Within 30 Days.|Number of participants readmitted to the hospital within 30 days of surgery|30 days||||participants|||Number
1431567|NCT00997516|Secondary|Time to Return to Work|Number of calendar days between participants' discharge from the hospital and the first day back at work.|30 days||||Days||Standard Deviation|Mean
1431568|NCT00997516|Secondary|Wound Seroma|Number of participants who experienced un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery.|6 months||||participants|||Number
1431573|NCT00997516|Secondary|Procedures Requiring Conversion to Open or Additional Port|Patients requiring use of additional incisions and/or trocars, or the need to perform an open procedure.|during surgery , up to 6 hours||||participants|||Number
1431575|NCT00997516|Primary|Pain After Surgery|Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.|12 hours post-surgery||||units on a scale||Standard Deviation|Mean
1431576|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431577|NCT00997503|Secondary|Rate of Stent Thrombosis (Protocol Definition)|"-Binary rate~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431578|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium~Binary Rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431579|NCT00997503|Secondary|Rate of Stent Thrombosis (ARC Definite + Probable)|"ARC - Academic Research Consortium~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431580|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431581|NCT00997503|Secondary|Rate of Major Bleeding|"Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431582|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431583|NCT00997503|Secondary|Rate of Stroke|-Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431584|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431585|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431586|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431587|NCT00997503|Secondary|Rate of Target Vessel Reintervention (TVR)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431588|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431589|NCT00997503|Secondary|Rate of Myocardial Infarction (MI): Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431590|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431591|NCT00997503|Secondary|Rate of Myocardial Infarction (MI)|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431592|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431593|NCT00997503|Secondary|Rate of Cardiac Death: Study Stent Related|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431594|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431595|NCT00997503|Secondary|Rate of Cardiac Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431596|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431597|NCT00997503|Secondary|Rate of All Cause Death|-Binary rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431598|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431599|NCT00997503|Secondary|Rate of Cardiac Death or Myocardial Infarction (MI)|- Binary Rate|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431600|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431601|NCT00997503|Secondary|Rate of Target Vessel Failure (TVF)|"Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.~Binary Rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431602|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431603|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE): Study Stent Related|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431604|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431605|NCT00997503|Secondary|Rate of Major Adverse Cardiac Events (MACE)|"MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431606|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431607|NCT00997503|Secondary|Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related|MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431608|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431609|NCT00997503|Secondary|Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)|"MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.~Binary rate"|6 months|There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431610|NCT00997503|Secondary|Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population|Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations|12 months|To be included, subject was a medically treated diabetic at the time of enrollment. Also, subjects met the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. There were 2945 subjects that did not meet the criteria for this analysis.|||percentage of participants|||Number
1431611|NCT00997503|Secondary|Incremental Rate of Stent Thrombosis (Protocol Definition)|"Stent Thrombosis (protocol definition):~The occurrence of any of the following:~Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:~Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion~Acute MI in the distribution of the treated vessel.~Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available."|1-2 years|To be analyzed in this secondary analysis, a subject needed to have an endpoint event between 1-2 years or sufficient follow-up through 2-years. There were 448 subjects that did not meet the criteria for this analysis.|||percentage of participants|||Number
1431612|NCT00997503|Primary|Cardiac Death or Myocardial Infarction|Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.|12 months|There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.|||percentage of participants|||Number
1431613|NCT00997438|Secondary|RANTES Levels||48 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.|||pg/mL||Standard Error|Mean
1431614|NCT00997438|Secondary|RANTES Levels||24 hour|Analyses were terminated when it became clear no consistent significant changes in RANTES were taking place.|||pg/mL||Standard Error|Mean
1431615|NCT00997438|Primary|cAMP Levels||4 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients|||pmol cAMP/mg protein||Inter-Quartile Range|Median
1431616|NCT00997438|Primary|cAMP Levels||2 hours|Useable PBMCs were not obtained from one healthy control and 2 relapsing remitting MS patients|||pmol cAMP/mg protein||Inter-Quartile Range|Median
1431617|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|48 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
1431618|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|24 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
1431619|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|4 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
1431620|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|3 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
1431621|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|2 hours|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
1431622|NCT00997438|Primary|Lipoic Acid Levels|Plasma concentration of LA|1 hour|Plasma samples from one secondary progressive and one healthy control subject did not yield results for unknown reason(s).|||ng/mL||Standard Error|Mean
1431623|NCT00997425|Primary|Number and Means of Exit Seeking (Door Approach Behaviors) and Exit Door Pass Through Behaviors (Eloping)|Door and floor cover interventions were compared for efficacy in reducing wandering behavior defined as patient approaching or passing through the equipped exit door. Counts of each behavior were collected on each patient for each intervention period. Mean values of counts were compared.|eight weeks|per protocol|||behavior counts||Standard Error|Mean
1431624|NCT00997373|Primary|Changes in Ki67 Expression After About 3 Weeks of Letrozole Treatment for Patients With Endometrial Cancer|Changes in %Ki67 staining cells by immunoperoxidase of paraffin embedded, formalin fixed tissue|At time of consent and after hysterectomy (generally about 3 weeks)|"Subjects completing treatment who had confirmed histopathology compared to a non-randomized group of untreated control subjects. Aromatase inhibitor responsiveness was defined as a proportionate decline in %Ki67 staining of at least 70% between pre-treatment biopsy and hysterectomy 9or repeat biopsy)."|||percentage of Ki67 staining cells||Full Range|Mean
1432944|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Usual Activities|Quality of Life Measured by Euro-QoL - Question 3: Usual activities.|Week 24|All available data from participants that reached week 24 are summarized.|||Participants|||Count of Participants
1431625|NCT00997334|Post-Hoc|Feasibility Rate|Feasibility in this study is defined as the percentage of patients who completed a repeated biopsy per protocol after evidence of disease progression.|Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.|The analysis dataset is comprised of all patients eligible for repeat biopsy.|||percentage of participants||90% Confidence Interval|Number
1431626|NCT00997334|Post-Hoc|Time to Repeat Biopsy|Time to repeat biopsy is the duration of time from clinical determination of progressive disease to time of repeat biopsy.|At time of removal from study, patients were asked to undergo a repeat biopsy of their progressing or new tumor lesion. Progression follow up was up to 3 years in this study cohort.|The analysis dataset is comprised of all evaluable patients.|||days||Full Range|Median
1431627|NCT00997334|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically every 8 weeks on treatment (cycle duration=4 weeks). Participants were treated until evidence of disease progression or unacceptable toxicity. Progression follow-up was up to 3 years in this study cohort.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1431628|NCT00997334|Primary|Resistance Mechanism|Participants were classified into 4 potential resistant mechanism groups (4 genetic/ 1 histologic) based on evaluation of rebiopsy tissue: EGFR mutations (T790M mutation, exon 20 insertion), KRAS mutations, MET amplification or small-cell lung cancer (SCLC) transform using established methods.|Participants were evaluated for incidence of genetic mechanisms of secondary resistance at time of disease progression at which point participants stopped treatment. Progression follow up was up to 3 years in this study cohort.|The analysis dataset is comprised of all evaluable patients.|||participants|||Number
1431629|NCT00997321|Secondary|Depth of Sedation|Observes assesment of alertness scale, 1-5 ordinal scale measuring level of awareness, one represents awake, 5 general anesthesia/unresponsive to pain|single measurement during sedation procedure|100 patients were randomized, 50 to the propofol group, 50 of whom underwent sedation, and 50 in the ketamine group, 47 of whom underwent sedation|||score on a scale||Full Range|Median
1431630|NCT00997321|Secondary|Patient Reported Pain or Recall of the Procedure|"patient completed question after return to baseline mental status did you feel pain during the procedure and do you remember any part of the procedure answered by circling yes or no on a question sheet, positive if yes to either question"|single measurement immediately after patient returns to baseline mental status after sedation procedure|100 patients were randomized, 50 to each group, 50 underwent the procedure in the propofol group and 47 in the ketamine group|||percentage of participants||95% Confidence Interval|Number
1431631|NCT00997321|Secondary|Time to Return of Baseline Mental Status|time in seconds from the first dose of medication until the patient has regained baseline mental status|from start of procedure until the return of baseline mental status up to 120 minutes|50 patients were randomized to the propofol group and 50 to ketamine, 50 underwent the procedure in the propofol group and 47 in the ketamine group|||minutes||95% Confidence Interval|Median
1431632|NCT00997321|Primary|Respiratory Depression (Sub-clinical and Clinical Signs)|binary measure based on the occurrence of an oxygen saturation less than 93 at any time, a change in baseline end tidal co2 >10 or an absence on capnographic waveform|From one minute prior to start of the procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure up to 60 minutes)|50 subjects were randomized to each group, 50 subjects in the propofol arm completed the study, 47 in the ketamine arm|||percentage of participants||95% Confidence Interval|Number
1431633|NCT00997243|Secondary|Explore the Biologic Role of microRNAs in Determining Clinical Response to the AZA Plus Lintuzumab Combination and Achievement of the Other Pharmacodynamic Endpoints||Up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
1431634|NCT00997243|Secondary|Perform Exploratory Studies of AZA-triphosphate With Global DNA Methylation||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
1431635|NCT00997243|Secondary|Provide Preliminary Data on the Biological Activity of AZA as a Demethylating Agent (Changes in Target Gene Methylation and Gene Expression, DNMT1[Deoxyribonucleic Acid Methyltransferase 1 DNA Methyltransferase 1]Protein Expression, Global Methylation)||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
1431636|NCT00997243|Secondary|Determine the Relationship Between Pretreatment Expression of Syk and Clinical Response; to Determine Whether the Investigational Agents Modulate Syk Expression and Correlate Drug-induced Changes in Syk With Response to Treatment||up to 5 years|No participants were analyzed due to withdrawal of the investigational agent by the company.||||||
1431637|NCT00997243|Secondary|Toxicities of the Combination|All patients who received study drug were closely monitored for adverse events (AEs). All AEs that occured during study period were reported and the investigator determined the severity and relationship to study drug (unrelated, unlikely, possibly, probably, or definitely related). The NCI's CTCAE(Common Toxicity Criteria for Adverse Effects)v3.0 was used for grading AEs.|up to 5 years||||percentage of participants|||Number
1431638|NCT00997243|Secondary|Overall Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years||||percentage of participants|||Number
1431639|NCT00997243|Primary|Complete Response Rate|Response to therapy was determined based on percentage of blasts in bone marrow, hematopoiesis, and requirement for supportive care (i.e., transfusions or cytokine growth factors). The modified International Working Group response criteria was used, based on Cheson, et al.|up to 5 years||||percentage of participants|||Number
1441658|NCT00923260|Primary|Components of Metabolic Syndrome (Low-Density Lipoproteins)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
1431640|NCT00997204|Secondary|Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort|Subjects assessed angioedema attack symptoms using the visual analogue scale (VAS) for skin pain, skin swelling and abdominal pain. The VAS is a continuous scale comprised of a 100 mm in length line, anchored by 2 verbal descriptors, one for each symptom extreme 0 (no pain) and 100 (worst pain). The respondent is asked to place a mark on the VAS line (any where between 0 and 100 mm) at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the line between the “no pain” anchor and the patient’s mark, providing a range of scores from 0–100. A higher score indicates greater pain intensity. Score interpretation is: no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), and severe pain (75–100 mm). Symptom relief is defined as at least a 50% reduction in a pre-dose VAS score of 30 mm or greater. The time to onset of symptom relief is defined as the first of 3 consecutive assessments at which symptom relief was observed.|48 hours post-dose||||Hours||Inter-Quartile Range|Median
1431641|NCT00997204|Primary|Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant|"Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant was assessed by calculating the number of AEs occurred during the study. Only those adverse events occurring up to the earlier of 7 days from the start of the naive phase, study discontinuation and start of the self-administration phase are assessed.~The Local Tolerability Assessment tool was used. Subjects and Investigators graded erythema/reddening, swelling, burning, pruritus/itching, warm sensation, and skin pain on a 0 to 3 severity scale."|7 days from the beginning of each phase||||participants|||Number
1431642|NCT00997139|Primary|MRSA Clearance Rate|Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment.|14 days||||percentage of subjects|||Number
1431643|NCT00997139|Primary|MSSA Clearance Rate|Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment.|14 days||||percentage of subjects|||Number
1431644|NCT00997139|Primary|Carrier Rate for Staphylococcus Aureus|Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab)|Baseline||||percentage of subjects|||Number
1431645|NCT00997126|Secondary|Patient Reported Recall of the Procedure||Single measurement immediately after patient returns to baseline mental status after sedation procedure||||participants|||Number
1431646|NCT00997126|Secondary|Patient Reported Pain||Single measurement immediately after patient returns to baseline mental status after sedation procedure||||participants|||Number
1431647|NCT00997126|Secondary|Depth of Sedation Measured Using the OAAS Scale|Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli|Single measurement during sedation procedure||||units on a scale||Inter-Quartile Range|Median
1431648|NCT00997126|Secondary|Time to Return of Baseline Mental Status From Start of Procedure in Minutes||Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours||||minutes||Inter-Quartile Range|Median
1431649|NCT00997126|Primary|Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure||From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)||||participants|||Number
1431650|NCT00997113|Secondary|Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure|Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure.|single time point measured after sedation procedure completed||||participants|||Number
1431651|NCT00997113|Secondary|Respiratory Depression|categorized as a change in end tidal CO2 from baseline >10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%.|From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status||||participants|||Number
1431652|NCT00997113|Primary|Change in Serum Catecholamines|change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.|one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes||||mcg/ml||Inter-Quartile Range|Median
1431653|NCT00997035|Secondary|Minimum Inhibitory Concentration of Isolates|Comparing Minimum inhibitory concentration of isolates by treatment arm|3 months after enrollment||2017-12-31|12/2017||||
1431654|NCT00997035|Secondary|Number of Adverse Events|Comparing the number of serious and non-serious adverse events by treatment arm.|3-months from enrollment||||adverse events|||Number
1431655|NCT00997035|Secondary|Microbiological Cure at 7 Days|Fungal Culture negative at 7 days post treatment|7 days|Fungal Culture negative at 7 days post treatment|||Participants|||Count of Participants
1431656|NCT00997035|Secondary|Hazard Ratio for Re-epithelialization|Hazard Ratio of re-epithelialization comparing the treatment groups|Up to 21 days||||Number re-epthelialized/person-days|||Number
1431657|NCT00997035|Secondary|Size of Infiltrate/Scar|Size of infiltrate/scar at 3 weeks after enrollment, using enrollment infiltrate scar/size as a covariate|3 weeks after enrollment|Mean infiltrate scar size at three weeks.|||mm^2||Standard Error|Mean
1431658|NCT00997035|Secondary|Size of Infiltrate/Scar - 3 Months|Size of infiltrate/scar at 3 months after enrollment, using enrollment infiltrate scar/size as a covariate|3 months after enrollment|Mean infiltrate scar size at three months correcting for baseline scar size and site|||mm^2||Standard Error|Mean
1431659|NCT00997035|Secondary|Best Spectacle-corrected logMAR Visual Acuity at 3-weeks|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear|3 weeks after enrollment|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and study site.|||logMAR||Standard Error|Mean
1431660|NCT00997035|Secondary|Best Spectacle-corrected logMAR Visual Acuity|Best spectacle-corrected logMAR visual acuity at 3 months after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear|3 months after enrollment|Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and study site|||logMAR||Standard Error|Mean
1431661|NCT00997035|Primary|Incidence of Perforation or Therapeutic Penetrating Keratoplasty|Hazard ratio of perforation or therapeutic penetrating keratoplasty (TPK) comparing voriconazole to placebo|3 months from enrollment|Comparison of rate of perforation or TPK between the treatment groups (topical voriconazole with oral voriconazole vs. topical voriconazole with oral placebo)|||New perforations or TPK/person-days|||Number
1431662|NCT00996996|Secondary|Number of Participants Who Received Thyroid Medication After Treatment|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population|||participants|||Number
1431663|NCT00996996|Secondary|Number of Participants With Low or Normal Baseline TSH Levels That Developed Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal Baseline TSH levels were assessed.|||participants|||Number
1431664|NCT00996996|Secondary|Number of Participants With the Adverse Event (AEs) of Hypothyroidism|Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone and is defined as either developing elevated TSH levels or initiating thyroid medication. An AE is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom, or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered to be related to the medical treatment or procedure, that occurs during the course of the study.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population|||participants|||Number
1431665|NCT00996996|Secondary|Time to Elevated TSH Post Baseline for Participants Who Had Low or Normal TSH Levels at Baseline and Elevated Levels Post Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were categorized to have elevated or normal/low TSH values per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years from the start of treatment|ITT-Exposed Population. Only those participants who had low or normal TSH levels at Baseline and elevated levels post Baseline were assessed.|||months||Full Range|Median
1431666|NCT00996996|Secondary|Participants With Elevated TSH Levels at Baseline With Post Baseline TSH Levels of Low/Normal and Elevated|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants with elevated TSH levels at Baseline were assessed.|||participants|||Number
1431667|NCT00996996|Secondary|Number of Participants With Elevated, Low, and Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline|TSH is a hormone that stimulates the thyroid gland to produce thyroxine (T4) and then triiodothyronine (T3), which stimulates the metabolism of almost every tissue in the body. Participants were considered to have normal, high, or low TSH levels per the standard TSH ranges of the testing laboratory.|Baseline|ITT-Exposed Population. Only those participants for whom TSH levels were recorded at Baseline were assessed.|||participants|||Number
1431668|NCT00996996|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who converted from being negative for HAMA at Baseline to being positive for HAMA any time following treatment were assessed.|||days||Standard Deviation|Mean
1431669|NCT00996996|Secondary|Number of Participants With Conversion to HAMA Positivity Any Time During the Study From Baseline|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population. Only those participants who were evaluable for HAMA were assessed.|||participants|||Number
1431670|NCT00996996|Secondary|Number of Participants Evaluable and Not Evaluable for Human Anti-Murine Antibodies (HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I-131 tositumomab. A positive HAMA value indicates that the participant developed HAMA above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of HAMA.|From Baseline up to 2 years from the start of treatment|ITT-Exposed Population|||participants|||Number
1431671|NCT00996996|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE)|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. A fatal SAE is a medical event that results in death.|From Baseline up to 12 years from the start of treatment (long-term follow up)|ITT-Exposed Population|||participants|||Number
1431672|NCT00996996|Secondary|Normal Organ Dosimetry for the Indicated Organs|Organ dosimetry was performed in participants using the kidneys, liver, lungs, spleen, red marrow, urinary bladder, and the remainder of the body as source organs. Organ doses and Iodine I-131 Anti-B1 Antibody biodistribution were comparable across the three Anti-B1 Antibody manufacturers. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). For the spleen (corrected) category, participant-specific corrections were made to account for individual spleen size.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants who had available gamma camera images for the indicated organs were assessed.|||cGy/75 cGy total body dose (TBD)||Standard Deviation|Mean
1431673|NCT00996996|Secondary|Total Body Effective Half-life (EHL)|Total body EHL is the time required for a radioactive element in the body to be diminished by 50% as a result of radioactive decay and biologic elimination. The EHL is equal to the product of the biologic half-life (BHL) and the radioactive half-life (RHL) divided by the sum of the BHL and the RHL: EHL=(BHL * RHL)/(BHL + RHL). BHL is the time it takes for a drug to lose half of its pharmacologic, physiologic, or radiologic activity. RHL is the time taken for half of the radioactive nuclei to decay.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population|||hours||Standard Deviation|Mean
1431674|NCT00996996|Secondary|Volume of Distribution at Infusion Time 0 (Vd0) and Steady State (Vdss)|Volume of distribution at the start of infusion and at steady state of I-131 tositumomab. The volume of distribution measures how much the drug spreads through the body after the dose. Steady state is defined as that state at which the overall intake of a drug is fairly in dynamic equilibrium with its elimination.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||milliliters (ml)||Standard Deviation|Mean
1431675|NCT00996996|Secondary|Maximum Concentration (Cmax) Values|Cmax is the maximum observed I-131 tositumomab concentration from time zero (end of the dosimetric dose infusion) to 120 hours after the end of the infusion. Unit: %ID/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. Cmax is the highest drug concentration in the blood after infusion.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||%ID/ml||Standard Deviation|Mean
1431676|NCT00996996|Secondary|Clearance Values|Clearance of I-131 tositumomab after intravenous administration was measured. The clearance of a drug measures the rate at which the drug is removed from the body after the dose.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||Milliliters per hour (ml/hr)||Standard Deviation|Mean
1431677|NCT00996996|Secondary|Area Under the Curve (AUC) at 0 to 120 Hours and 0 to Infinity Hours|Area under the concentration-time curve for I-131 tositumomab from time 0 to 120 hours and time 0 to infinity hours (extrapolated) after the end of the dosimetric dose infusion was measured. Unit: %ID*h/ml, where %ID/ml is the percentage of the injected dose per milliliter of blood. AUC measures how much drug is in the system over time after infusion.|0-120 hours and 0-infinity hours from the dosimetric dose (given only on Day 0) and 0-120 hours and 0-infinity hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||%ID*h/ml||Standard Deviation|Mean
1431678|NCT00996996|Secondary|Terminal Half-life (t1/2beta)|t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||hours||Standard Deviation|Mean
1431679|NCT00996996|Secondary|Initial Half-life (t1/2alpha)|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|0-120 hours from the dosimetric dose (given only on Day 0) and 0-120 hours from the therapeutic dose (given only on Day 7)|ITT-Exposed Population. Only those participants for whom pharmacokinetic blood samples were collected at the indicated time points were assessed.|||hours||Standard Deviation|Mean
1431680|NCT00996996|Secondary|Progression-free Survival (PFS) Based on Participants’ Baseline PCR Status|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent. PFS is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR status taken at Baseline were evaluated for PFS.|||months||95% Confidence Interval|Median
1431681|NCT00996996|Secondary|Duration of Response (the Time From the First Documented Response to the First Documented Progression) for Participants Who Were PCR Positive at Baseline and Converted to PCR Negative Status After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who were PCR positive at Baseline and converted to a status of PCR negative were assessed.|||months||95% Confidence Interval|Median
1446651|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])||Baseline up to Month 7||||percentage of participants|||Number
1431682|NCT00996996|Secondary|Number of Participants Who Were Polymerase Chain Reaction (PCR)-Positive at Baseline With Bone Marrow Conversion to a Status of PCR Positive and Negative Any Time After Treatment|PCR is a scientific technique in molecular biology to amplify a single copy or a few copies of a piece of deoxyribonucleic acid (DNA) across several orders of magnitude, generating thousands to millions of copies of a particular DNA sequence. Applications of PCR technique include: selective DNA isolation, amplification and quantification of DNA, and the diagnosis of diseases. PCR positive: interchromosomal translocation t(14;18) is present. PCR negative: t(14;18) is absent.|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants with a PCR-positive status at Baseline were assessed. One participant had a Baseline measurement but no post Baseline measure, and was thus not assessed.|||participants|||Number
1431683|NCT00996996|Secondary|Number of Participants With Resolution of All Baseline B-symptoms by the End of the Study|"The Ann Arbor staging system of lymphomas is used to summarize the extent of the cancer's spread. Stages are classified by Roman numerals I (less spread) to IV (more spread). If the following symptoms (called B-symptoms) are present, a B classification is added to the stage: night sweats, intermittant fever, and weight loss. B-symptoms indicate the presence of systemic symptoms. The presence or absence of B-symptoms has prognostic significance and is reflected in the staging of these lymphomas."|Baseline and up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced any B-symptom at Baseline were assessed. Not all participants experienced all B-symptoms at Baseline; thus, the number of participants analyzed represents all participants who experienced at least one B-symptom.|||participants|||Number
1431684|NCT00996996|Secondary|Time to Progression of Disease or Death (Progression-free Survival)|Time to progression is defined as the time from the treatment start date to the first documented progression or death. Progressive Disease is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who experienced disease progression or died were assessed.|||months||95% Confidence Interval|Median
1431685|NCT00996996|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only those participants who died during the study due to any cause were assessed.|||months||95% Confidence Interval|Median
1431686|NCT00996996|Secondary|The Estimated Value Represents the Percentage of Participants With a PR|Duration of response (CR, CCR, or PR) is defined as the time from the first documented response to the first documented progression. Progressive Disease (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants who experienced confirmed CR, CCR, or PR with PD were assessed. Response (R) had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented.|||months||95% Confidence Interval|Median
1431687|NCT00996996|Primary|Number of Participants With Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population|||participants|||Number
1431688|NCT00996996|Primary|Number of Participants With Confirmed Complete Response (CR, CCR, and CR+CCR) and Partial Response (PR)|Responses were confirmed by two separate response evaluations at least 4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population. Only participants evaluable for confirmed response (R) were assessed. R had to be confirmed by a consecutive R that was the same or better >=4 weeks apart. Each individual confirmed R category only counts the R confirmed by the exact same R; therefore, not all possible combinations are represented in the table.|||participants|||Number
1431689|NCT00996996|Primary|Number of Participants With Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), or Partial Response (PR)|CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population|||participants|||Number
1431690|NCT00996996|Primary|Number of Participants With Confirmed Response, Including Participants With Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|Confirmed response required CR, CCR, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart. CR: Complete resolution of all disease-related radiological abnormalities and disappearance of all signs and symptoms related to the disease. CCR: Complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|From Study Day 0 (start of treatment) up to 12 years (long-term follow up)|ITT-Exposed Population: all participants who were enrolled in the study and received at least one dose of study drug. Only participants evaluable for confirmed response were assessed.|||participants|||Number
1431710|NCT00996931|Secondary|Change in Childhood Autism Rating Scale (CARS)Value From Baseline to 6 Weeks|Change in CARS value from baseline to 6 weeks. Total CARS scores range from a fifteen to 60, with a minimum score of thirty serving as the cutoff for a diagnosis of autism on the mild end of the autism spectrum.|Baseline and 6 weeks|Intention to treat|||mean change in units on scale||Standard Deviation|Mean
1431691|NCT00996944|Secondary|Drug Clearance Rate On-Dialysis and Off-Dialysis During the Maintenance Dose Treatment Phase (in the Long-term Treatment Period)|For on-dialysis analysis, measurements were to have been taken 1 hour before dialysis, in the artery/vein at the beginning, during, and end of dialysis, and 1 hour after dialysis. For off-dialysis analysis, measurements were to have been taken 1 hour before dialysis, at the beginning, during, and end of dialysis, and 1 hour after dialysis.|Week 12 through Week 64|PK analysis was not performed because there were no participants (who had received a maintenance dose of the IP for more than 1 week in the long-term treatment period) from whom a blood sample could be collected when decision of study termination was made.||||||
1431692|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|LONG WD (up to Week 64)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the and LONG WD data.|||hours||Standard Deviation|Mean
1431693|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|DBT WD (up to Week 12)|FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the DBT WD data.|||hours||Standard Deviation|Mean
1431694|NCT00996944|Secondary|Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12|Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.|Week 0 and Week 12|FAS. Participants without symptoms were not included in the analysis of Week 0 data. Participants without symptoms and participants prematurely withdrawn from the study were not included in the analysis of Week 12 data.|||hours||Standard Deviation|Mean
1431695|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.|||participants|||Number
1431696|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||participants|||Number
1431697|NCT00996944|Secondary|Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12|Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||participants|||Number
1431698|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1431699|NCT00996944|Secondary|The PSQI Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in this analysis.|||units on a scale||Standard Deviation|Mean
1431700|NCT00996944|Secondary|The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12|The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1431701|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1431702|NCT00996944|Secondary|Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1431703|NCT00996944|Primary|IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12, and 2 participants had missing DBT WD data.|DBT WD (up to Week 12)|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.|||units on a scale||Standard Deviation|Mean
1431704|NCT00996944|Secondary|Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12|The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.|Week 0 and Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1431705|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|LONG WD (up to Week 64)|FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.|||participants|||Number
1431706|NCT00996944|Secondary|Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|DBT WD (up to Week 12)|FAS. Participants with missing DBT WD data were not included in the analysis.|||participants|||Number
1431707|NCT00996944|Secondary|Number of Participants With the Indicated Clinical Global Impression–Improvement (CGI-I) Scores at Week 12|The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.|Week 12|FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.|||participants|||Number
1431708|NCT00996944|Secondary|IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS.|LONG WD (up to Week 64)|FAS. One participant in each group had no measurement data and thus was not included in the analysis. These two participants were withdrawn from the study without receiving the IP in the long-term treatment period.|||units on a scale||Standard Deviation|Mean
1431709|NCT00996944|Primary|International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12|The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12.|Week 0 and Week 12|Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.|||units on a scale||Standard Deviation|Mean
1431711|NCT00996931|Primary|Change in TNF-alpha Levels|Change in CSF-TNF-α from baseline to 12 weeks.|Baseline and 12 weeks|Intention to treat|||mean % change||Standard Deviation|Mean
1431712|NCT00996918|Secondary|Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state|Weeks 6, 19, 32, 45 and 78||||Units on a scale||Standard Error|Least Squares Mean
1431713|NCT00996918|Secondary|Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Weeks 6, 19, 32, 45 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431714|NCT00996918|Secondary|Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431715|NCT00996918|Secondary|Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Weeks 26, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431716|NCT00996918|Secondary|Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78|The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431717|NCT00996918|Secondary|Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.|The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants’caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants’ ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431725|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1432945|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Self-Care|Quality of Life Measured by Euro-QoL - Question 2: Self-Care.|Week 24|All available data from participants that reached week 24 are summarized.|||Participants|||Count of Participants
1431718|NCT00996918|Secondary|Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431719|NCT00996918|Secondary|Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.|The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.|Weeks 13, 26, 39, 52 and 78|The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.|||Units on a scale||Standard Error|Least Squares Mean
1431720|NCT00996918|Primary|Number of Participants Reporting a Serious Adverse Event.|Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.|Up to Week 195|The Safety Population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).|||Number of participants|||Number
1431721|NCT00996892|Secondary|Progression-Free Survival (PFS) - Dose Escalation Stages 1, 1A and 1B|PFS was the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.||||||
1431722|NCT00996892|Secondary|Duration of Objective Response - Dose Escalation Stages 1, 1A and 1B|Duration of objective response was defined as the time from first occurrence of a documented objective response (CR or PR) until the time of disease progression, as determined by investigator review of tumor assessments using RECIST, or death from any cause during the study (within 30 days after the last dose of study treatment). CR = disappearance of all target and non-target lesions. PR = at least 30 % decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. PD = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Data for this outcome measure was not collected as per changes in planned analysis.||||||
1431723|NCT00996892|Secondary|Number of Participants With Best Overall Response - Dose Escalation Stages 1, 1A and 1B|Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) = disappearance of all target and non-target lesions. Partial Response (PR) = at least 30 percent (%) decrease in sum of the longest diameter of measured lesions taking as reference the baseline sum of the longest diameter. Progressive disease (PD) = at least 20% increase in the sum of the longest diameter of measured lesions taking as reference the smallest sum of the longest diameter since treatment start or appearance of one or more new lesions. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment start.|Up to 30 days after last dose (last dose = up to Cycle 15, cycle length = 28 days)|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
1431724|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431726|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431727|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431728|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431729|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431730|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431731|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431732|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431733|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431734|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431735|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431736|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431737|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1432198|NCT00994682|Secondary|Prevention of the Onset of T2DM and/or Reversal From IFG/IGT to NGT in Non-diabetics.|Number of patients developing T2DM and number of patients regressing to NGT among patients with prediabetes (IFG/IGT).|18 months|Only patients with prediabetes are included in this analysis|||Participants|||Count of Participants
1431738|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as median.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431739|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431740|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431741|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 2A Individual Indication Specific Cohorts|Stage 2A PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431742|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431743|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431744|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431745|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431746|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431747|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431748|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431749|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431750|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431751|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431801|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431752|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431753|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately. Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431754|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431755|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431756|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431757|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 2 All Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431758|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431759|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 2 Individual Indication Specific Cohorts|Stage 2 PK data were reported for each indication specific cohort separately.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431760|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431761|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431762|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431763|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431764|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431765|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431766|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431767|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431768|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2 and 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431769|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431770|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431771|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431772|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431773|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431774|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431775|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 1B All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431776|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431777|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431778|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431779|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431780|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431781|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431782|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431783|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431784|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431785|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 18 divided by AUC0-24 at Cycle 1 Day 1.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 18, Cycle 1 Days 2, 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431802|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431786|NCT00996892|Secondary|CL/F of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431787|NCT00996892|Secondary|t1/2 of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431788|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431789|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431790|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 18 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 18, Cycle 1 Day 19, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431791|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431792|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431793|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 – Stage 1A All Cohorts||Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Days 2, 8, 15-17|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431794|NCT00996892|Secondary|Accumulation Ratio of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Days 1 and 21, Cycle 1 Day 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431795|NCT00996892|Secondary|CL/F of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1431796|NCT00996892|Secondary|t1/2 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half. As planned, summary statistics were not derived if fewer than 3 participants had available data; however, if the number of participants analyzed = 1, then the observed data of the single participant was reported as geometric mean.|Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431797|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431798|NCT00996892|Secondary|Cmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431799|NCT00996892|Secondary|Tmax of Pictilisib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431800|NCT00996892|Secondary|AUC0-24 of Pictilisib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 8, Cycle 1 Day 9; Cohorts 4-6A: Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431803|NCT00996892|Secondary|Accumulation Ratio of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Accumulation ratio was calculated as: AUC0-24 at Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) divided by AUC0-24 at Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3).|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 8 and 28, Cycle 1 Days 9, 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Days 1 and 21, Cycle 1 Days 2, 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1431804|NCT00996892|Secondary|Apparent Clearance (CL/F) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1431805|NCT00996892|Secondary|Terminal Half-life (t1/2) of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts|Half-life is the time measured for the plasma concentration to decrease by one half.|Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Geometric Mean
1431806|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431807|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431808|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 21 (Cycle 1 Day 28 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 28, Cycle 1 Day 29, Cycle 2 Days 1, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 21, Cycle 1 Day 22, Cycle 2 Days 1, 15, 21|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431809|NCT00996892|Secondary|AUC0-24 of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431810|NCT00996892|Secondary|Cmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431811|NCT00996892|Secondary|Tmax of Cobimetinib on Cycle 1 Day 1 (Cycle 1 Day 8 for Cohorts 1-3) – Stage 1 All Cohorts||Cohorts 1-3: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 8, Cycle 1 Days 9, 15, 21; Cohorts 4-6A: Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Cycle 1 Day 1, Cycle 1 Day 2, 8, 14|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431812|NCT00996892|Primary|AUC0-24 of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1431813|NCT00996892|Primary|Cmax of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours Pr-P dose, 0.5, 2, 4, 6 hours Po-P dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1431814|NCT00996892|Primary|Tmax of Pictilisib on Day 1 – Stage 1, Cohorts 1-3||0-4 hours pre-pictilisib (Pr-P) dose, 0.5, 2, 4, 6 hours post-pictilisib (Po-P) dose on Day 1, Day 2, 0-4 hours Pr-C dose on Day 3|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1431815|NCT00996892|Primary|Area Under the Concentration-Time Curve From Time 0 to 24 Hours Post-Dose (AUC0-24) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nonograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1431816|NCT00996892|Primary|Maximum Plasma Concentration (Cmax) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours Pr-C dose, 0.5, 2, 4, 6 hours Po-C dose on Day 3, Day 4|PK population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1431817|NCT00996892|Primary|Time of Maximum Concentration (Tmax) of Cobimetinib on Day 3 – Stage 1, Cohorts 1-3||0-4 hours pre-cobimetinib (Pr-C) dose, 0.5, 2, 4, 6 hours post-cobimetinib (Po-C) dose on Day 3, Day 4|Pharmacokinetic (PK) population included all participants who had at least one cobimetinib and pictilisib plasma concentration available. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
1446652|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])||Baseline up to Month 7||||percentage of participants|||Number
1431818|NCT00996892|Primary|Maximum Tolerated Combination Doses of Cobimetinib and Pictilisib During Dose-Escalation Stages 1, 1A and 1B|MTD was determined (by Investigator) based on the DLTs, as well as adverse events (AEs) in dose-escalation Stages 1, 1A, and 1B that did not meet protocol-defined DLT criteria but indicated intolerability of a given dose combination. Separate combination MTDs were determined for each dose-escalation stage. DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non–hepatic organ toxicity; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants evaluable for specified categories.|||mg|||Number
1431819|NCT00996892|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) During Dose Escalation Stages 1, 1A and 1B|DLT was defined as 1 of the following toxicities considered treatment related by Investigator: Grade ≥3 non-hematologic, non–hepatic organ toxicity, excluding the following: Grade 3 nausea, vomiting, or diarrhea that resolved to Grade ≤1 within 7 days, Grade 3 rash or Grade ≥3 fatigue that resolved to Grade ≤2 within 7 days, Grade ≥3 hyperglycemia or lipid profile results that occurred during non-fasting conditions, Grade 3 or 4 elevation of serum creatine phosphokinase levels or Grade 3 non clinically significant (as assessed by Investigator) laboratory abnormality that was asymptomatic; Grade ≥3 febrile neutropenia; Grade ≥4 neutropenia (absolute neutrophil count <500/microliter) lasting >5 days; Grade ≥4 thrombocytopenia lasting >48 hours; Grade ≥4 anemia; Grade ≥3 total bilirubin, hepatic transaminase, alkaline phosphatase, lasting >72 hours; Grade ≥2 diffusion capacity of the lung for carbon monoxide concomitant with an absolute decrease of ≥20 percentage points from baseline.|Cohorts 1-3: Day 1 to Day 35, All other cohorts: Day 1 to Day 28|Safety-evaluable population included all participants who received at least one dose of study drug. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
1431820|NCT00996840|Secondary|Maximum Observed Concentration (Cmax) of SB-681323|Absolute values of the Cmax of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3)|PK population. Only those participants available at the specified time points were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
1431821|NCT00996840|Secondary|Mean Average Concentration (Cavg) of SB-681323|Absolute values of mean Cavg of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10 min, 24h 45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h 10minutes [min], 24h 45min, 27, 34, 40, 80 h since doing on Day 3)|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
1431822|NCT00996840|Secondary|Mean Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 Hours (AUC0-24)|Absolute values of the mean AUC 0-24 of SB-681323 were reported. PK samples were collected for cohort 1 and 3 at Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h) and for cohort 2 and 4 at Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose, 24h10minutes [min], 24h45min, 27, 34, 40, 80 h since doing on Day 3).|For cohort 1 and 3: Day 1 (pre-dose, 4, 4.25, 5, 6, 8, 12, 18h), Day 2 (pre-dose and 4h), Day 3 (0, 4, 24, 48h). For cohort 2 and 4: Day 1 (pre-dose), Day (pre-dose), Day 3 (pre-dose)|Pharmacokinetic (PK) population was defined as patients in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Note: Due to some placebo patients PK samples being assayed in error, the above PK population definition was adjusted to also exclude any patient receiving Placebo.|||h*ng/mL||95% Confidence Interval|Geometric Mean
1431823|NCT00996840|Secondary|Markers of Lung Epithelial Cell Injury: Mean Myeloperoxidase (MPO) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of MPO levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||pg/mL||95% Confidence Interval|Geometric Mean
1431824|NCT00996840|Secondary|Markers of Endothelial Cell/Neutrophil Interaction: Mean Soluble Tumor Necrosis Factor Receptors-I|Samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of soluble tumor necrosis factor receptors-I levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||pg/mL||95% Confidence Interval|Geometric Mean
1431825|NCT00996840|Secondary|Mean Serum C-Reactive Protein (CRP) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of serum CRP levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||mg/L||95% Confidence Interval|Geometric Mean
1431826|NCT00996840|Secondary|Mean Serum CXCL8 (Interleuin-8) Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum CXCL8 (Interleuin-8) levels at these specified time points were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|PD Population. Only those participants available at the specified time points were analyzed.|||pg/ml||95% Confidence Interval|Geometric Mean
1431871|NCT00996736|Secondary|Hard Contact Lens-corrected Visual Acuity Measured in logMAR|Hard contact lens-corrected visual acuity measured in logMAR (logarithm of the Minimum Angle of Resolution) 3 months after enrollment|3 months after enrollment||||logMAR||95% Confidence Interval|Mean
1446653|NCT00879814|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Baseline up to Month 7||||percentage of participants|||Number
1431827|NCT00996840|Secondary|Mean Serum Interleukin-6 Levels|Serum samples were collected at 6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1. Mean absolute values of Serum interleukin-6 levels at these specified time oints were reported.|6, 12, 18, 24, 48, 72 and 96 h since first dose on Day 1|Pharmacodynamic (PD) Population was defined as patients in the ‘All Subjects’ population for whom a pharmacodynamic sample was obtained and analysed (Flow Cytometry data were excluded from the definition of pharmacodynamic sample). Only those participants available at the specified time points were analyzed.|||Picogram per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
1431828|NCT00996840|Primary|Number of Participants With Any Adverse Events (AE) and Serious Adverse Events (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Follow-up (Day 7)|All subject population.|||Participants|||Count of Participants
1431829|NCT00996840|Primary|Mean Electrocardiogram (ECG) Parameters Including PR, QRS, QT, and QTcB, QTcF, RR Intervals|12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measures RR, PR, QRS, QT, and QTc intervals. Absolute mean values of PR, QRS, QT, and QTcB, QTcF, RR intervals were reported.|Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow-up (Day 7)|All subject population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
1431830|NCT00996840|Primary|Vital Signs: Mean Oxygen Requirement (FiO2) Via Pulse Oximetry|Assessment of mean FiO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.||||||
1431831|NCT00996840|Primary|Vital Signs: Mean Level of Peak and Plateau Ventilator Pressures|Assessment of mean level of peak and plateau ventilator pressures was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.||||||
1431832|NCT00996840|Primary|Vital Signs: Mean Level of Positive End Expiratory Pressure|Assessment of level of positive end expiratory pressure was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.||||||
1431833|NCT00996840|Primary|Vital Signs: Mean Oxygen Saturation (SaO2) Via Pulse Oximetry|Assessment of SaO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.|For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”; for Cohort 2 and 4: “Day 2, pre-dose”, and “Day 3, pre-dose and 24 h”|All subject population. Data was not collected for this parameter.||||||
1431834|NCT00996840|Primary|Vital Sign: Mean Percent Oxygen (O2) in Blood|Absolute values of mean percent O2 in blood were reported.|"For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and Follow up (Day 7); for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Percent O2||Standard Deviation|Mean
1431835|NCT00996840|Primary|Vital Parameter: Mean Heart Rate|Absolute values of mean heart rate were reported.|"For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and Follow up (Day 7); for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1431836|NCT00996840|Primary|Vital Parameter- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Absolute values of SBP and DBP were reported.|"For Cohort 1 and 3: “Day 1, 4 h”, “Day 2, pre-dose”, “Day 3, pre-dose and 24 h” and Follow up (Day 7); for Cohort 2 and 4: “Day 2, pre-dose”, “Day 3, pre-dose and 24 h”, and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Millimeter of Mercury (mmHg)||Standard Deviation|Mean
1431837|NCT00996840|Primary|Mean Clinical Chemistry Parameters-Blood pH at Screening|Absolute values of Blood pH at screening were reported as clinical chemistry parameter.|Screening|All subject population. Only those participants available at the specified time points were analyzed.|||pH Units||Standard Deviation|Mean
1431838|NCT00996840|Primary|Mean Clinical Chemistry Parameters-estradiol|Absolute values of Estradiol were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|Day 1 (pre-dose) and Day 3 (24 h)|All subject population. Only those participants available at the specified time points were analyzed. Data were not collected from participants in Cohort 2-SB-681323, 7.5 mg, 24 h, Cohort 3-SB-681323, 7.5 mg, 4 h, and Cohort 4-SB-681323, 10 mg, 24 h.|||Picomole per liter||Standard Deviation|Mean
1432199|NCT00994682|Secondary|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (CK-18).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||U/L||95% Confidence Interval|Mean
1431839|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN)|Absolute values of calcium, chloride, glucose, bicarbonate, potassium, sodium and Urea/BUN were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Millimole per liter||Standard Deviation|Mean
1431840|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Absolute values of direct bilirubin, total bilirubin, creatinine and uric acid were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Micromol per liter||Standard Deviation|Mean
1431841|NCT00996840|Primary|Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase|Absolute values of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
1431842|NCT00996840|Primary|Mean Clinical Chemistry Parameters- Albumin and Total Protein|Absolute values of albumin and total protein were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
1431843|NCT00996840|Primary|Mean Hematology Parameters-reticulocytes, Red Blood Cell Count|Absolute values of reticulocytes and red blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Trillion cells per liter (TI/L)||Standard Deviation|Mean
1431844|NCT00996840|Primary|Hematology Parameters-Mean Corpuscle Volume|Absolute values of mean corpuscle volume were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
1431845|NCT00996840|Primary|Mean Hematology Parameters- Mean Corpuscle Hemoglobin|Hematology parameter mean corpuscle hemoglobin was reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Picogram (pg)||Standard Deviation|Mean
1431846|NCT00996840|Primary|Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)|Mean hematology parameters including hemoglobin, MCHC were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject population. Only those participants available at the specified time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
1431847|NCT00996840|Primary|Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count|Mean hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, white blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.|"“Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7)"|All subject Population comprised of as all participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Giga cells per liter||Standard Deviation|Mean
1431848|NCT00996801|Primary|Number of Participants With Predefined Tier 1 Adverse Events|Osteonecrosis of the jaw (ONJ), kidney stones, and bone neoplasms were predefined Tier-1 AEs in the study (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons).|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1431849|NCT00996801|Primary|Number of Participants With Trough Albumin-Corrected Calcium Level Exceeding Predefined Limits At Least Once|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least one albumin-corrected calcium level value ≥10.6 mg/dL were considered as having a Tier 1 AE (an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons)."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1431872|NCT00996736|Secondary|Best Spectacle-corrected logMAR Visual Acuity|Best spectacle-corrected logMAR (logarithm of the Minimum Angle of Resolution) visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model|3 weeks after enrollment|306 total subjects (155 in natamycin arm, 151 in voriconazole arm) returned after enrollment for a second visit, but only 293 of those (149 in natamycin arm and 144 in voriconazole arm) visited within the 3-week window (2.5-5 weeks). Only those who visited within the window were included in the analysis.|||logMAR||95% Confidence Interval|Mean
1431850|NCT00996801|Primary|Number of Participants With Trough Serum Calcium Level Exceeding Predefined Limits At Least Once|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with at least a one calcium level value ≥10.6 mg/dL were considered as having a Tier 1 adverse event (AE). A Tier 1 AE was an AE of special interest identified a priori that could be used for inferential testing for statistical significance for between-group comparisons."|Baseline through Month 12|All Participants as Treated (APaT): all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1431851|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Osteocalcin|"Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter~(mL)."|Baseline and Month 12|Analysis of osteocalcin was not conducted when it was determined that the efficacy of MK-5442 was not significantly different than placebo.||||||
1431852|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of μg/L.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431853|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum N-Terminal Propeptide (s-P1NP)|s-P1NP is a sensitive marker of bone formation rate in the assessment of osteoporosis and is measured in units of ng/ml.|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431854|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Serum C-Terminal Propeptide of Type 1 Collagen (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis and in measured in units of nanograms (n)/milliliter (ml).|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431855|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Urinary-N Telopeptides of Type 1 Collagen (u-NTx)|"Urinary, type I collagen, crosslinked N-telopeptide (uNTx) is a biomarker used to measure the rate of bone turnover found in urine.~uNTx was expressed in units of nanomoles (nM) per bone collagen equivalents (BCE) per millimoles of creatinine (Cr) or nM/BCE/mM Cr"|Baseline and Month 12|"Per Protocol Population: defined as the subset of the APaT population that excluded participants based on critical protocol violations.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431856|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcomes analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431857|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Cortical Volumetric BMD of the Lumbar Spine|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431858|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD of the Hip|vBMD was measured using QCT in order to assess bone strength. QCT is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431859|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trabecular Volumetric BMD (vBMD) of the Lumbar Spine|vBMD was measured using quantitative computed tomography (QCT) in order to assess bone strength. Quantitative computed tomography is a three-dimensional non-projectional technique that quantifies trabecular and cortical BMD in the lumbar spine and hip as a true volumetric mineral density in g/cm^3.|Baseline and Month 12|"Full Analysis Set (FAS), QCT Subset: QCT was performed on a subset of the FAS (participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data).~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431898|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen N-Propeptide (PIIANP) Level|Level of PIIANP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431860|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in 1/3 Distal Forearm Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431861|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Body Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431862|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Trochanter Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431863|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Femoral Neck Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431864|NCT00996801|Secondary|Least Squares Mean Percent Change From Baseline to Month 12 in Total Hip Areal BMD|"Areal bone mineral density (BMD) was measured using DXA scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431865|NCT00996801|Primary|Least Squares Mean Percent Change From Baseline To Month 12 in Lumbar Spine Areal Bone Mineral Density (BMD)|"Areal bone mineral density (BMD) was measured using dual-energy X-ray absorptiometry (DXA) scanning technology. Scanning is performed with two X-ray beams with different energy levels which are aimed at the participant's bones. When soft tissue absorption is subtracted out, the BMD is determined from the absorption of each beam by bone.~BMD = BMC / W, where BMD = bone mineral density in g/cm^2, BMC = bone mineral content in g/cm, and W = width at the scanned line in cm"|Baseline and Month 12|"Full Analysis Set (FAS): participants who received at least one dose of study treatment, had at least one post-randomization observation, and who had baseline data.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."|||percent change||95% Confidence Interval|Least Squares Mean
1431866|NCT00996775|Primary|Reduction in Percentage of Heavy Drinking Days|"reduction in the percentage of heavy drinking days over the prior 30-days.~a heavy drinking day was defined as drinking above gender-matched NIAAA drinking limits (e.g., greater than 4 drinks on one occasion for men)."|baseline to six-month follow-up||||percentage of heavy drinking days||Standard Deviation|Mean
1431867|NCT00996736|Secondary|Microbiological Cure at 6 Days|Microbiological cure defined as no fungal growth on culture at 6 (+/-1) days from enrollment|7 days after enrollment|Of the 323 participants with smear-positive ulcers enrolled in the trial, 299 (92.6%) were scraped and cultured 6 days after enrollment - 155 in the natamycin arm, and 144 in the voriconazole arm.|||participants|||Number
1431868|NCT00996736|Secondary|Minimum Inhibitory Concentration of Isolates|Minimum inhibitory concentration (50th percentile) of fungal isolates to natamycin and voriconazole|3 months after enrollment|The population for analysis included only those subjects with positive fungal cultures and for whom Minimum Inhibitory Concentrations were available (108 subjects who were randomized to natamycin and 113 who were randomized to voriconazole).|||μg/ml||95% Confidence Interval|Mean
1431869|NCT00996736|Secondary|Time to Resolution of Epithelial Defect|Time in days from enrollment to resolution of epithelial defect. For those subjects with more than 21 days to resolution, 21 days was used.|From enrollment to the time of resolution of epithelial defect||||days||Standard Deviation|Mean
1431870|NCT00996736|Secondary|Size of Infiltrate/Scar|Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate|3 weeks and 3 months after enrollment||||mm||95% Confidence Interval|Mean
1432946|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Mobility|Quality of life measured by Euro-QoL - Question 1: Mobility.|Week 24|Available data for participants that reached week 24 are summarized.|||Participants|||Count of Participants
1431873|NCT00996736|Primary|Best Spectacle-corrected logMAR Visual Acuity|The primary analysis is best spectacle-corrected logMAR (logarithm of the Minimum Angle or Resolution) visual acuity, correcting for enrollment BSCVA and treatment arm in a multiple linear regression model. The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|3 months from enrollment||||logMAR||95% Confidence Interval|Mean
1431874|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
1431875|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
1431876|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
1431877|NCT00996658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks|Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline FPG value and an on-treatment FPG value. Three subjects in each arm excluded for site non-compliance.|||mg/dL (milligrams per deciliter)||Standard Error|Least Squares Mean
1431878|NCT00996658|Secondary|Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication. Three subjects in each arm excluded for site non-compliance.|||Participants|||Number
1431879|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=6.5% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.|||Participants|||Number
1431880|NCT00996658|Secondary|Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had HbA1c >=7.0% at baseline (NCF). Three subjects in each arm excluded for site non-compliance.|||Participants|||Number
1431881|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 18 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1431882|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 12 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1431883|NCT00996658|Secondary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 6 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1431884|NCT00996658|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks|Glycosylated hemoglobin is reported as a percentage of the total hemoglobin|baseline, 24 weeks|Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Three subjects in each arm excluded for site non-compliance.|||Percentage||Standard Error|Least Squares Mean
1431885|NCT00996632|Secondary|Time of Discharge|evaluation about the time of discharge from hospital|days||||Days||Standard Deviation|Mean
1431886|NCT00996632|Primary|Drainage Volume|volume in milliliters of axillary drainage|discharge day|the number of participants for analysis was determined by mean of power sample size calculation|||milliliters||Standard Deviation|Mean
1431887|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×ME by DYNAMIKA Software Analysis|Ntotal and ME were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of NtotalME was expressed as voxels times ratio of signal intensity before and after contrast injection (v*ratio). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||v*ratio||Standard Deviation|Mean
1431899|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen C-Terminal Telopeptide (ICTP) Level|Level of ICTP was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431888|NCT00996606|Secondary|Change From Baseline to Week 48 in Ntotal×IRE by DYNAMIKA Software Analysis|Ntotal and IRE were approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. The mean of three different slices was used in the determination of IRE. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Function of Ntotal×IRE was expressed as voxels times change in relative intensity per second (v*ΔI/sec). Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||v*ΔI/sec||Standard Deviation|Mean
1431889|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Washout Enhancing Voxels (Nwashout) by DYNAMIKA Software Analysis|Nwashout was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nwashout. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||washout enhancing voxels||Standard Deviation|Mean
1431890|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Plateau Enhancing Voxels (Nplateau) by DYNAMIKA Software Analysis|Nplateau was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Nplateau. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||plateau enhancing voxels||Standard Deviation|Mean
1431891|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Persistent Enhancing Voxels (Npersistent) by DYNAMIKA Software Analysis|Npersistent was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Npersistent. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||persistent enhancing voxels||Standard Deviation|Mean
1431892|NCT00996606|Secondary|Change From Baseline to Week 48 in Number of Enhancing Voxels (Ntotal) by DYNAMIKA Software Analysis|Ntotal was approximated using DYNAMIKA software. The sum of three different slices was used in the determination of Ntotal. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||enhancing voxels||Standard Deviation|Mean
1431893|NCT00996606|Secondary|Change From Baseline to Week 48 in Maximum Enhancement (ME) by DYNAMIKA Software Analysis|ME was approximated by parametric mapping via DYNAMIKA software and expressed as ratio of signal enhancement before and after contrast injection. The mean of three different slices was used in the determination of ME. Each slice consisted of a 2D sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||ratio||Standard Deviation|Mean
1431894|NCT00996606|Secondary|Change From Baseline to Week 48 in Initial Rate of Enhancement (IRE) by DYNAMIKA Software Analysis|IRE was approximated by parametric mapping via DYNAMIKA software and expressed as change in relative signal intensity per second (ΔI/sec). The mean of three different slices was used in the determination of IRE. Each slice consisted of a two-dimensional (2D) sequence of images acquired from the same physical location at different time instances. Baseline AV and change from Baseline to Week 48 were averaged among all participants.|Baseline and Week 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||ΔI/sec||Standard Deviation|Mean
1431895|NCT00996606|Secondary|Change From Baseline to Day 2 and Weeks 2 and 4 in Soluble Transferrin Receptor (STR) Concentration|Level of STR was measured in pg/mL. Baseline AV and changes from Baseline to Day 2 and Weeks 2 and 4 were averaged among all participants.|Baseline; Day 2; and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431896|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Hemoglobin (Hb) Concentration|Level of Hb was measured in grams per liter (g/L). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||g/L||Standard Deviation|Mean
1431897|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type II Collagen Helical Peptide (HELIX-II) Level|Level of HELIX-II was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1432200|NCT00994682|Secondary|Plasma Biomarkers Relevant to Hepatic Inflammation, Apoptosis and Fibrosis (Adiponectin).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||μg/ml||95% Confidence Interval|Mean
1431900|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in C-Terminal Telopeptide (CTX)-1 Level|Level of CTX-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431901|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Type I Collagen N-Propeptide Level|Level of Type I collagen N-propeptide was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431902|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Osteocalcin Level|Level of osteocalcin was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431903|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Monocyte Chemoattractant Protein (MCaP)-1 Level|Level of MCaP-1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431904|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-17 Level|Level of IL-17 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431905|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-1β Level|Level of IL-1β was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431906|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Tumor Necrosis Factor (TNF)-α Level|Level of TNF-α was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431907|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in A Proliferation-Inducing Ligand (APRIL) Level|Level of APRIL was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431908|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Activating Factor (BAFF) Level|Level of BAFF was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431909|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Stromal Cell-Derived Factor (SDF) 1 Level|Level of SDF1 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431910|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in B Cell-Attracting Chemokine (BCA) Level|Level of BCA was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431911|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17CCL17 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431912|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cysteine-Cysteine Chemokine Ligand (CCL) 20 Level|Level of Th17CCL20 was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431913|NCT00996606|Secondary|Change From Baseline to Week 4 in Plasma B Cell Level|The absolute number of plasma B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
1431914|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of B Cells|The intensity of plasma B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
1431915|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Plasma B Cells as a Percentage of PBMCs|The intensity of plasma B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431916|NCT00996606|Secondary|Change From Baseline to Week 4 in Transitional B Cell Level|The absolute number of transitional B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
1431917|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of B Cells|The intensity of transitional B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
1431918|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Transitional B Cells as a Percentage of PBMCs|The intensity of transitional B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431919|NCT00996606|Secondary|Change From Baseline to Week 4 in Memory B Cell Level|The absolute number of memory B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
1431920|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of B Cells|The intensity of memory B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
1431921|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Memory B Cells as a Percentage of PBMCs|The intensity of memory B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431922|NCT00996606|Secondary|Change From Baseline to Week 4 in Mature B Cell Level|The absolute number of mature B cells was expressed as cells/mcL. Baseline AV and change from Baseline to Week 4 were averaged among all participants.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
1431923|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of B Cells|The intensity of mature B cell infiltration was expressed as the percentage of B cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of B cells||Standard Deviation|Mean
1431924|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Mature B Cells as a Percentage of PBMCs|The intensity of mature B cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431925|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IgM Mean Intensity of Fluorescence|The mean fluorescence intensity of IgM-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431926|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Immunoglobulin (Ig) M-Positive Cells as a Percentage of PBMCs|The intensity of IgM-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431927|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD38-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431928|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD38-Positive Cells as a Percentage of PBMCs|The intensity of CD38-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431929|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD27-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431930|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD27-Positive Cells as a Percentage of PBMCs|The intensity of CD27-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431931|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD24-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431932|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD24-Positive Cells as a Percentage of PBMCs|The intensity of CD24-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431933|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431934|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD19-Positive Cells as a Percentage of PBMCs|The intensity of CD19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431935|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cell Level|The absolute number of Th17 cells was expressed as cells/mcL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
1431936|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Th17 Cells as a Percentage of T Cells|The intensity of Th17 cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of T cells||Standard Deviation|Mean
1431937|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Helper T (Th) 17 Cells as a Percentage of PBMCs|The intensity of Th17 cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431938|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cell Level|The absolute number of Treg cells was expressed as cells per microliter (cells/mcL). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||cells/mcL||Standard Deviation|Mean
1432035|NCT00996437|Secondary|Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy|"The proportion of eyes with complete panretinal photocoagulation by 16 weeks in abscence of vitrectomy was computed using the life-table method and treatment groups were compared using the log-rank test."|within 112 days of randomization|The secondary analysis followed the intent-to-treat principle and included all randomized eyes.|||percentage of eyes|||Number
1431939|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Treg Cells as a Percentage of T Cells|The intensity of Treg cell infiltration was expressed as the percentage of T cells. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of T cells||Standard Deviation|Mean
1431940|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Regulatory T (Treg) Cells as a Percentage of PBMCs|The intensity of Treg cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431941|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23Rp19 Mean Intensity of Fluorescence|The mean fluorescence intensity of IL-23Rp19-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431942|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in IL-23 Receptor p19 Subunit (IL-23Rp19)-Positive Cells as a Percentage of PBMCs|The intensity of IL-23Rp19-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431943|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431944|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR4-Positive Cells as a Percentage of PBMCs|The intensity of CCR4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431945|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CCR6 Mean Intensity of Fluorescence|The mean fluorescence intensity of CCR6-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431946|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cysteine-Cysteine Chemokine Receptor (CCR) 6-Positive Cells as a Percentage of PBMCs|The intensity of CCR6-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431947|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD45RO Mean Intensity of Fluorescence|The mean fluorescence intensity of CD45RO-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431948|NCT00996606|Secondary|"Change From Baseline to Weeks 2 and 4 in CD45 RO Isoform (RO)-Positive Cells as a Percentage of PBMCs"|The intensity of CD45RO-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431949|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD25-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431950|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD25-Positive Cells as a Percentage of PBMCs|The intensity of CD25-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1432036|NCT00996437|Primary|Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)||Baseline to 16 weeks|Adverse events for each participants was collected throughout study duration.|||participants|||Number
1431951|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in CD4 Mean Intensity of Fluorescence|The mean fluorescence intensity of CD4-positive cells was measured by flow cytometry. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||fluorescence intensity units||Standard Deviation|Mean
1431952|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Cluster of Differentiation (CD) 4-Positive Cells as a Percentage of Peripheral Blood Mononuclear Cells (PBMCs)|The intensity of CD4-positive cell infiltration was expressed as the percentage of PBMCs. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percentage of PBMCs||Standard Deviation|Mean
1431953|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for Forkhead Box Protein (FOXP) 3 (2^ΔCt) Level|Level of mRNA for FOXP3 (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
1431954|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for RAR-Related Orphan Receptor (ROR)-γT (2^ΔCt) Level|Level of ROR-γT (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
1431955|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in mRNA for IL-23 Receptor (2^ΔCt) Level|Level of mRNA for IL-23 receptor (2^ΔCt) was quantified by PCR. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
1431956|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Messenger Ribonucleic Acid (mRNA) for Interleukin (IL)-17 (2^Delta Cycle Threshold [ΔCt]) Level|Level of mRNA for IL-17 (2^ΔCt) was quantified by polymerase chain reaction (PCR). Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||2^ΔCt||Standard Deviation|Mean
1431957|NCT00996606|Secondary|Change From Baseline to Weeks 2 and 4 in Soluble Interleukin-6 Receptor (sIL6R) Level|Level of sIL6R was measured in pg/mL. Baseline AV and changes from Baseline to Weeks 2 and 4 were averaged among all participants.|Baseline and Weeks 2, 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431958|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in High-Sensitivity C-Reactive Protein (hsCRP) Concentration|Level of hsCRP was measured in mg/dL. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||mg/dL||Standard Deviation|Mean
1431959|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erythrocyte Sedimentation Rate (ESR)|ESR was measured in millimeters per hour (mm/h). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||mm/h||Standard Deviation|Mean
1431960|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Vascular Endothelial Growth Factor (VEGF) Concentration|Level of VEGF was measured in picograms per milliliter (pg/mL). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||pg/mL||Standard Deviation|Mean
1431961|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Disease Activity Score of 28 Joints (DAS28) Score|The DAS28 was derived from assessments of C-reactive protein (CRP), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] plus (+) [0.28 × square root of SJC] + [0.36 × natural log (CRP + 1)] + [0.014 × VAS] + 0.96. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. CRP was measured in milligrams per deciliter (mg/dL). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
1431999|NCT00996593|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.|||participants|||Number
1431962|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI assessed 20 items in eight functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score was calculated as an average of all item scores, and thus also ranged from 0 to 3. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated an increase in ability to perform activities independently.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
1431963|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived General Health According to VAS Score|Global assessment of disease activity was performed using a 0- to 100-mm VAS, where the distance from 0 mm represented the investigator's evaluation or the participant's self evaluation of disease activity (0 mm = no disease activity, 100 mm = maximum disease activity). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||mm||Standard Deviation|Mean
1431964|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Perceived Pain According to Visual Analog Scale (VAS) Score|Perceived pain was assessed on a 0- to 100-millimeter (mm) VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm = no pain, 100 mm = maximum pain). Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated a decrease in perceived pain.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||mm||Standard Deviation|Mean
1431965|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Ritchie Articular Index Score|The Ritchie Articular Index was scored on a scale of 0 to 3, according to the grades of tenderness in each of 26 assessed joints. The total score was taken as the sum of joint scores and ranged from 0 to 78. Scores of 0 reflected no tenderness, while higher scores reflected increased tenderness. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in joint tenderness.|Baseline and Weeks 2, 4, 12, 24, 48|ITT Population. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
1431966|NCT00996606|Secondary|Change From Baseline to Weeks 24 and 48 in Total Modified Sharp Score (TMSS), Erosion Score (ES), and Joint Space Narrowing Score (JSNS)|The TMSS was calculated as the sum of ES and JSNS and ranged from 0 to 202. The ES was taken as the sum of joint scores collected for 14 joints in each hand (individually scored from 0 to 7) and ranged from 0 to 98 for both hands. The JSNS was the sum of joint scores collected for 13 joints in each hand (individually scored from 0 to 8) and ranged from 0 to 104 for both hands. Scores of 0 reflected no change, while higher scores reflected increased disease activity. Baseline AV and changes from Baseline to Weeks 24 and 48 were averaged among all participants, where negative changes indicated improvement in disease activity.|Baseline and Weeks 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1431967|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Bone Marrow Edema of the Wrist and MCP Joints According to RAMRIS Score|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 45) and MCP joints (range, 0 to 24). Aggregate wrist and MCP joint scores could range from 0 to 69 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1431968|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Bone Marrow Edema in the Wrist and MCP Joints|Edema was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone edema was scored on a scale of 0 to 3, where 0 represented no bone edema and each 1-point increase reflected one-third increase in extent of edema. The number of bones with edema was taken as the count of joints with a bone edema score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in edema.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||bones with bone marrow edema||Standard Deviation|Mean
1431969|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Erosion of the Wrist and MCP Joints According to RAMRIS Score|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to 10% increase in extent of erosion. Global RAMRIS scores were calculated as the sum of all joint sites for the wrist (range, 0 to 150) and MCP joints (range, 0 to 80). Aggregate wrist and MCP joint scores could range from 0 to 230 points. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1431970|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Number of Bones With Erosion in the Wrist and MCP Joints|Erosion was evaluated at 15 sites in the wrist and 8 sites in the MCP joints. Bone erosion was scored on a scale of 0 to 10, where 0 represented no bone erosion and each 1-point increase reflected up to a 10% increase in extent of erosion. The number of bones with erosion was taken as the count of joints with a bone erosion score greater than or equal to (≥) 1. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in erosion.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||bones with erosion||Standard Deviation|Mean
1431971|NCT00996606|Secondary|Change From Baseline to Weeks 2, 4, 12, 24, and 48 in Synovitis of the Wrist and Metacarpo-Phalangeal (MCP) Joints According to Modified RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Synovitis of MCP joints was determined on the basis of Short Inversion Time Inversion Recovery (STIR) sequence evaluation with modification of the RAMRIS score. Four MCP joint compartments were each assessed 0 to 3, so the aggregated MCP joint score ranged from 0 to 12. Combined synovitis in wrist and MCP joints was determined on the basis of STIR sequences to produce overall score from 0 to 21. Baseline AV and changes from Baseline to Weeks 2, 4, 12, 24, 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 4, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1431972|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to REE Per Second Before and After Contrast Injection|REE per second was calculated as [S55 – S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent rate of early enhancement||Standard Deviation|Mean
1431973|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RE Before and After Contrast Injection|RE was calculated as [S0 – S55] ÷ S0 × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent relative enhancement||Standard Deviation|Mean
1431974|NCT00996606|Secondary|Change From Baseline to Weeks 2, 12, 24, and 48 in Synovitis of the Wrist According to RAMRIS Score|Synovitis of the wrist was assessed at three sites including the RUJ, the RCJ, and the IC-CMCJ. Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. The changes from Baseline to Weeks 2, 12, 24, and 48 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Weeks 2, 12, 24, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1431975|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rate of Early Enhancement (REE) Per Second Before and After Contrast Injection|REE per second was calculated as [S55 – S0] ÷ [S0 × 55 seconds] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent rate of early enhancement||Standard Deviation|Mean
1431976|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Relative Enhancement (RE) Before and After Contrast Injection|RE was calculated as [S0 minus (–) S55] divided by (÷) S0, multiplied by (×) 100 percent (%), where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||percent relative enhancement||Standard Deviation|Mean
1432965|NCT00988442|Secondary|Change in CD4 Cell Count at Week 48|Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4.|Baseline and Week 48|Only 16 participants had week 48 CD4 observations to be included in this analysis.|||cells/mm^3||95% Confidence Interval|Mean
1431977|NCT00996606|Primary|Change From Baseline to Week 4 in Synovitis of the Wrist According to Rheumatoid Arthritis Magnetic Resonance Imaging (RAMRIS) Score|Synovitis of the wrist was assessed at three sites including the radioulnar joint (RUJ), the radiocarpal joint (RCJ), and the intercarpal-carpometacarpal joints (IC-CMCJ). Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Baseline absolute value (AV) and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.|Baseline and Week 4|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of participants who contributed to the analysis at each timepoint (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
1431978|NCT00996593|Primary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
1431979|NCT00996593|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed.|||days||Full Range|Median
1431980|NCT00996593|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||participants|||Number
1431981|NCT00996593|Secondary|Nadir Values for Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||cells/microliter||Full Range|Median
1431982|NCT00996593|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||G/dL||Full Range|Median
1431983|NCT00996593|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||cells/millimeters cubed (mm^3)||Full Range|Median
1431984|NCT00996593|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||days||Full Range|Median
1431985|NCT00996593|Secondary|Number of Participants With Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. All participants who experienced any SAE were analyzed.|||participants|||Number
1431986|NCT00996593|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.|||participants|||Number
1431987|NCT00996593|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||participants|||Number
1431988|NCT00996593|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population|||participants|||Number
1431989|NCT00996593|Primary|Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants who experienced progression were evaluated.|||months||95% Confidence Interval|Median
1431990|NCT00996593|Primary|Progression-free Survival for Participants With or Without a Prior Response to Rituximab|Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.|||months||95% Confidence Interval|Median
1431991|NCT00996593|Primary|Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.|||months||95% Confidence Interval|Median
1431992|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.|||participants|||Number
1431993|NCT00996593|Primary|Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab|Duration of response is defined as the time from the first documented response to disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with a response were analyzed.|||months||95% Confidence Interval|Median
1431994|NCT00996593|Primary|Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study|Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.|||participants|||Number
1431995|NCT00996593|Primary|Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator|Response duration is defined as the time from the first documented response until progressive disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
1431996|NCT00996593|Primary|Duration of Response for CR and CCR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR + CCR response and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
1431997|NCT00996593|Primary|Duration of Response for Confirmed CR as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed CR and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
1431998|NCT00996593|Primary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Response duration is defined as the time from the first documented response until disease progression.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
1432201|NCT00994682|Secondary|Total Body Fat|Total body fat measured by dual-energy x-ray absorptiometry (DXA)|Months 18|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively).|||Percentage of body weight that is fat||Standard Deviation|Mean
1432000|NCT00996593|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.|||participants|||Number
1432001|NCT00996593|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1432002|NCT00996593|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1432003|NCT00996580|Secondary|Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication|||pregnancies / cumulative exposure||95% Confidence Interval|Number
1432004|NCT00996580|Primary|Summary of Participants With Treatment-emergent Adverse Events|"The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date.~Relationship to study drug was assessed by the investigator.~Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Day 1 up to 13 months|Safety population of treated participants|||participants|||Number
1432005|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
1432006|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 28-day cycle and no other birth control methods including condoms were used.|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
1432034|NCT00996437|Secondary|Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength|Optical coherence tomography signal strength was evaluated as a potential indicator of vitreous hemorrhage density in an exploratory analysis. This analysis included only eyes with Optical Coherence Tomography (OCT) signal strength equals to 0 at baseline.|4, 8 and 12 weeks|This analysis followed the intent-to-treat principle|||percentage of eyes|||Number
1441659|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
1432007|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycle-Equivalents and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(13)/(total number of 28-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 28-day cycle.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
1432008|NCT00996580|Secondary|All Users Life-Table Estimates of Pregnancy Rates Based on 91-day Cycles and Broken Out by Subpopulations Defined by Participant Weight|A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the four 91-day treatment cycles.|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.|||pregnancies / cumulative exposure||95% Confidence Interval|Number
1432009|NCT00996580|Primary|Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|'Compliant-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods were used. Cycles were excluded if a subject 1) skipped 2 or more consecutive combination pills, 2) had a pattern of substantial non-compliance with treatment, or 3) used a prohibited concomitant medication|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
1432010|NCT00996580|Primary|Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'Typical-Use' set included PITT participants who completed at least one 91-day cycle and no other birth control methods including condoms were used.|||pregnancies / 100 woman years exposure||95% Confidence Interval|Number
1432011|NCT00996580|Primary|All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight|"Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-103 or > 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound.~The PI is defined as number of contraceptive failures per 100 women-years of exposure:~(100)*(total number of pregnancies)*(4)/(total number of 91-day cycles)"|Day 1 up to year 1|Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age when study treatment started. The 'All Users' set included PITT participants who completed at least one 91-day cycle.|||pregnancies / 100 woman years exposure|Participants|95% Confidence Interval|Number
1432012|NCT00996502|Secondary|Proportion of Patients Alive at One Year (Phase II)||One year|||||||
1432013|NCT00996502|Secondary|Overall Survival Rate||2 years|||||||
1432014|NCT00996502|Secondary|Objective Response Rate at the Recommended Phase II Dose Level of Docetaxel, Bevacizumab, Erlotinib, and Prednisone||Every 9 weeks|||||||
1432015|NCT00996502|Primary|Maximum Tolerated Dose of Docetaxel in Combination With Erlotinib, Bevacizumab, and Prednisone (Phase I)||After three 21-day cycles|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2010.||||||
1432016|NCT00996476|Primary|The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications|"The table below shows the number of participants who met response-guided treatment (RGT) stopping criteria in the TMC435 treatment groups. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20 were to stop all study medication (TMC435, PegIFNα-2a, and ribavirin) at Week 24. All other participants continued PegIFNα-2a and ribavirin until Week 48. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
1432202|NCT00994682|Secondary|Body Mass Index (BMI)||Months 18 and 36|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||kg/m^2||Standard Deviation|Mean
1432017|NCT00996476|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|"The table below shows the median time in hours to reach the maximum plasma concentration (tmax) of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.|||Hours||Full Range|Median
1432018|NCT00996476|Primary|The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435|"The table below shows the mean AUC24 of TMC435 for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg) who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|within 15 minutes and at 1, 2, 4, 6, 8, 12, and 24 hours post-dose between Week 4 and Week 6 after the initiation of treatment|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.|||ng∙h/mL||Standard Deviation|Mean
1432019|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling)|"The table below shows the mean predose plasma concentration (C0h) for participants in the 2 TMC435 50 mg treatment groups combined and for participants in the 2 TMC435 100 mg treatment groups combined who had intensive blood samples collected at Weeks 4 to 6. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4 to 6|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom intensive blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Standard Deviation|Mean
1432020|NCT00996476|Primary|Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling)|"The table below shows the mean (standard deviation) predose plasma concentration (C0h) for participants in each treatment group at Weeks 4, 12, and 24. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, and 24|Pharmacokinetic (PK) analysis was performed in the PK population defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Standard Deviation|Mean
1432021|NCT00996476|Primary|The Percentage of Participants With Sustained Virologic Response (SVR)|"The table below shows the percentage of participants with a SVR4, SVR12, and SVR24 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (EOT) (up to Weeks 24 or 48) and at 4, 12, and 24 weeks, respectively, after the last dose of treatment. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|SVR4 (up to Week 28 or Week 52), SVR12 (up to Weeks 36 or 60), and SVR24 (up to Weeks 48 or 72)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
1432022|NCT00996476|Primary|The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT)|"The table below shows the number of participants whose ALT results were within the normal range on Day 1 (initial day of treatment), Week 24, 48, and EOT (up to Weeks 24 or 48).The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1, Weeks 24, 48, and EOT (up to Weeks 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
1432023|NCT00996476|Primary|Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period|"The table below shows the mean (standard deviation) of the actual HCV RNA values by treatment group at Baseline and Weeks 4, 12, 24, 48, end of treatment (EOT, up to Weeks 24 or 48), Weeks 60 and 72 (Week 24 in the post-treatment follow-up period). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Baseline, Week 4, 12, 24, 48, EOT (up to Week 24 or 48), and Weeks 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||log10 IU/mL||Standard Deviation|Mean
1432024|NCT00996476|Primary|The Percentage of Participants With Viral Relapse|"The table below shows the percentage of participants in each treatment group who experienced viral relapse within 12 weeks (ie, at Week 36 or 60) after actual end of treatment (EOT) (up to Week 24 or 48). Viral relapse was defined as confirmed detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels during the post treatment follow-up period at Weeks 36 or 60 in participants with undetectable plasma HCV RNA at EOT. The statistical analysis shows the difference in treatments (ie, each TMC435 group minus PR48 control) in viral relapse. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
1432025|NCT00996476|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the 48 week treatment period with at least one study medication (TMC435 or PegIFNα-2a and ribavirin). Viral breakthrough is defined as a confirmed increase of greater than (>) 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of > 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable during the treatment period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to EOT (up to Week 24 or 48)|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Participants|||Number
1432026|NCT00996476|Primary|The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up|"The table below shows the percentage of participants in each treatment group with plasma HCV RNA levels undetectable or below the limit of quantification (<1.2 log10 IU/mL detectable ) at time points during treatment and post treatment follow-up.The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 4, 12, 24, 36, 48, EOT (up to Week 24 or 48), and Week 60 and 72|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
1432027|NCT00996476|Primary|The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period|"The table below shows the percentage of participants in each treatment group with a decrease of greater than (>) or equal (=) to 2 log10 IU/mL from baseline in plasma HCV RNA levels at time points during the treatment period and post treatment follow-up period. The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Days 1 (4 hr), 1 (8 hr), 3, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24,28, 36, 42, 48, 52, 60, 72, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
1432028|NCT00996476|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study|"The table below shows the percentage of participants in each treatment group with undetectable plasma HCV RNA levels at Weeks 4, 12, 24, 48, and end of treatment (EOT, up to Week 24 or 48). The number of participants analyzed is listed at each time point in order of the treatment groups from left to right in the table (ie, Week x, n=x, x, x, x, and x) if different from the “Number of Participants Analyzed.NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24 or 48, and EOT (up to Week 24 or 48)|Efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||Percentage of participants|||Number
1432029|NCT00996476|Primary|Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4|"The table below shows the least-squares (LS) mean change and 95% confidence intervals (CI) change from baseline at Week 4 in HCV RNA levels for participants in the 2 TMC435 50 mg treatment groups combined (TMC12/PR24 50 mg and TMC24/PR24 50 mg) and for participants in the 2 TMC435 100 mg treatment groups combined (TMC12/PR24 100 mg and TMC24/PR24 100 mg). The statistical analyses show the difference in LS mean change from baseline from the PR48 control group and the 95% CI for each dose group (ie, each TMC435 dose group minus PR48 control). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 1 (Baseline) and Week 4|The efficacy analyses were based on the per protocol set (PPS) of participants and consisted of a subset of participants in the full analysis set (FAS) which had no major protocol violations suspected to influence efficacy assessment and had data available at the time point(s) analyzed.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
1432030|NCT00996437|Secondary|Very Severe Visual Acuity Loss (Defined as <20/800)||4,8 and 12 weeks|Participants with a completed 4, 8 and 12 week visit respectively and an available visual acuity measurement were included in the analysis.|||percentage of participants|||Number
1432031|NCT00996437|Secondary|Severe Visual Acuity Loss (Defined as <20/200)||4,8 and 12 weeks|Participant with a completed 4,8 and 12 week visit and an available visual acuity measurement were included in this analysis.|||percentage of participants|||Number
1432032|NCT00996437|Secondary|Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit||4, 8 and 12 weeks|This analysis followed the intent-to-treat principle. It includes all randomized eyes with a completed 4, 8 and 12 week visit respectively and an available visual acuity measure.|||percentage of participants|||Number
1432033|NCT00996437|Secondary|Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status|Visual acuity was analyzed using a longitudinal mixed regression model adjusting for baseline visual acuity.Unit of measure is based on the E-ETDRS visual acuity letter score scale, 0-97, where 0 = worst and 97 = best.|4, 8 and 12 weeks|Number of participants with a complete 4 week visit, 8 and 12 week respectively and an available visual acuity measurement.|||letter scores||Standard Deviation|Mean
1446880|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
1432037|NCT00996437|Primary|"Treatment or Failure Defined as Vitrectomy"|The cumulative probabilities of vitrectomy by 16 weks (112 days) in each group were computed using the life-table method. The treatment group comparison was made using the log-rank test. Data were censored at the time point of the participant's last completed visit.|within 112 days of randomization|The primary analysis followed the intent-to-treat principle and included all randomized eyes.|||percentage of participants|||Number
1432038|NCT00996372|Secondary|Change From Baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R)|The FSDS© is a self-administered measure of female personal distress associated with sexual dysfunction. Question 13 inquires about distress specifically related to sexual desire. The range for each question, including Question 13, is 0 (Never) to 4 (Always).|change from baseline to 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Least Squares Mean
1432039|NCT00996372|Primary|Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain|The FSFI© is a brief, self-administered questionnaire to assess key dimensions of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (with 1 being the lowest report of desire and 5 being the highest). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0 (the higher the score, the higher the reported level of desire).|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.|||units on a scale||Standard Deviation|Mean
1432040|NCT00996372|Primary|Change From Baseline in the Number of Satisfying Sexual Events|A small handheld electronic device (eDiary) was used by patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they could enter information about their sexual events since their most recent entry up to a maximum of seven days in the past.|baseline through 24 weeks|The full analysis set (FAS), consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, had at least one baseline value of either one of the co-primary endpoints or key secondary endpoint, and had data available. The FAS was analyzed for efficacy.|||sexual events||Standard Deviation|Mean
1432041|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Temsirolimus|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month||||milligrams|||Number
1432042|NCT00996346|Primary|Maximum Tolerated Dose (MTD) of Irinotecan|The MTD is the dose preceding that at which at least 2 out of 3 patients in the treatment group experience a dose limiting toxicity (DLT). DLT is defined as grade 3 neutropenia on retreatment day, a grade 4 febrile neutropenia, a drug-related grade 3 or 4 non-hematologic toxicity (except fatigue, nausea, vomiting or grade 3 hypersensitivity reaction) or a grade 2 or greater motor or sensory neuropathy|Up to 1 month||||milligrams/meter squared|||Number
1432043|NCT00996333|Secondary|Toxicity Assessment|Data was not analyzed because original PI left institution before data analysis was completed.|Every month|||||||
1432044|NCT00996333|Secondary|Determine Overall and One Year Survival Rates|Data was not analyzed because original PI left institution before data analysis was completed.|One year|||||||
1432045|NCT00996333|Primary|To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks|||||||
1432046|NCT00996307|Secondary|Antibody Persistence by Geometric Mean Titers (GMT)|Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.|6 months (Day 202) and 12 months (Day 387) after second vaccination|The analysis was done on the subgroup of the per-protocol set (PPS).|||Titer||95% Confidence Interval|Geometric Mean
1432047|NCT00996307|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity|Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set (PPS).|||Titres||95% Confidence Interval|Geometric Mean
1432048|NCT00996307|Secondary|Antibody Response Based on Baseline Seropositivity|Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set (PPS).|||Percentages of Subjects||95% Confidence Interval|Number
1432049|NCT00996307|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup on the per-protocol set (PPS).|||Titers||95% Confidence Interval|Geometric Mean
1432050|NCT00996307|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.|Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)|The analysis was done on the subgroup of the per-protocol set(PPS).|||Percentages of Subjects||95% Confidence Interval|Number
1432051|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination|Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.|Day 22 to 28|The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination.|||Participants|||Number
1432052|NCT00996307|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination|Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.|Day 1 to 7|The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS.|||Participants|||Number
1432053|NCT00996307|Secondary|Immunogenicity Measurement by Geometric Mean Titers (GMT)|Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.|21 days after each vaccination|The analysis was done on the Full Analysis Set (FAS).|||Titers||95% Confidence Interval|Geometric Mean
1432054|NCT00996307|Primary|Antibody Responses After the First and Second Vaccinations|CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.|21 days after each vaccination|The analysis was done on the per-protocol set (PPS).|||Percentages of Subjects||95% Confidence Interval|Number
1432055|NCT00996281|Secondary|Percentage of Participants With Serum Creatinine Elevations Greater Than 50% From Baseline and Greater Than the Upper Limit of Normal (ULN)|Serum creatinine was measured at every visit and evaluated as a laboratory parameter of special interest. The percentage of participants with creatinine increase ≥50% from Baseline and greater than ULN was summarized: - At any visit (includes transient and persistent elevations). - At the Final Visit (includes persistent elevations and participants whose first elevation may have been at the Final Visit). - At least 2 consecutive visits (includes only persistent elevations).|Baseline and Week 52|Safety analysis set.|||percentage of participants|||Number
1432056|NCT00996281|Primary|Percentage of Participants With at Least 1 Adverse Event|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product without regard to causality.|From Week 0 (Day 1) to Week 52.|Safety analysis set: All participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1432057|NCT00996216|Secondary|Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)|SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.|From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.|||Participants|||Number
1432058|NCT00996216|Primary|Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population|||Participants|||Number
1432059|NCT00996216|Primary|Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2|LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population|||Participants|||Number
1432060|NCT00996216|Primary|Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2|Visual acuity (VA) is defined as acuteness or clearness of vision.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Entire Safety Population: all participants in the Pre-antiviral Safety Population|||Participants|||Number
1432061|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2|Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population|||Participants|||Number
1432062|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1|Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.|||Participants|||Number
1432063|NCT00996216|Primary|Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population|||Participants|||Number
1432064|NCT00996216|Primary|Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1|Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.|From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.|||Participants|||Number
1432065|NCT00996216|Primary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)|Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy|||Participants|||Number
1432066|NCT00996216|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)|Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study|||Participants|||Number
1432067|NCT00996216|Secondary|Number of Particpants Who Initiated Antiviral Therapy|The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.|From the start of the investigational product up to 9 weeks (median of 21 days)|Pre-antiviral Safety Population|||Participants|||Number
1432068|NCT00996216|Secondary|Platelet Counts at the Indicated Time Points|Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.|From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)|Pre-antiviral Safety Population|||Gi/L||Standard Deviation|Mean
1432069|NCT00996203|Secondary|Erythrocyte Sedimentation Rate|ESR (mm/hr) is used to determine the acute phase response.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mm/hr||Standard Deviation|Mean
1432070|NCT00996203|Secondary|C-Reactive Protein|CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mg/L||Standard Deviation|Mean
1432071|NCT00996203|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of participants|||Number
1432072|NCT00996203|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of participants|||Number
1432073|NCT00996203|Secondary|Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of participants|||Number
1432074|NCT00996203|Primary|Change in HAQ Score at Week 24|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline and Week 24|ITT population|||units on a scale||Standard Deviation|Mean
1432075|NCT00996203|Primary|Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Weeks 4, 8, 12, 16, 20, and 24|ITT population:|||percentage of participants|||Number
1432076|NCT00996203|Secondary|Change in DAS28 Score From Baseline to Week 24||Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1432077|NCT00996203|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||units on a scale||Standard Deviation|Mean
1432078|NCT00996203|Secondary|Change in General Health Assessed by VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
1432079|NCT00996203|Secondary|Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||percentage of Participants|||Number
1432080|NCT00996203|Secondary|General Health Score as Assessed by EQ-5D VAS|Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mm||Standard Deviation|Mean
1432081|NCT00996203|Secondary|Change in EQ-5D Score at Week 24 From Baseline|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1432082|NCT00996203|Secondary|European Quality of Life - 5 Dimensions (EQ-5D) Score|EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||units on a scale||Standard Deviation|Mean
1432083|NCT00996203|Secondary|Pain Score as Assessed by Visual Analogue Scale (VAS)|Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Weeks 0, 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed at a specific visit.|||mm||Standard Deviation|Mean
1432084|NCT00996203|Primary|Health Assessment Questionnaire (HAQ) Score|HAQ includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.|Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit|Intent-to-Treat (ITT) population: All participants randomized in the study who received administration of at least one dose of the study drug and who had at least one efficacy assessment performed. n (number) = number of participants assessed at a specific visit.|||units on a scale||Standard Deviation|Mean
1432094|NCT00996125|Primary|Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens|Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).|One month after the third dose (at Month 7)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1432085|NCT00996164|Primary|Change From Baseline in the SSE Count From Baseline to 24 Weeks|"The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula:~Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered).~Satisfying means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.~An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry."|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.|||SSEs||Standard Deviation|Mean
1432086|NCT00996164|Primary|The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.|The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.|24 weeks|The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.|||units on a scale||Standard Error|Mean
1432087|NCT00996125|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1432088|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 30 days (Days 0 – 29) after any vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1432089|NCT00996125|Secondary|Number of Subjects Reporting Pregnancies and Pregnancy Outcomes||Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1432090|NCT00996125|Secondary|Number of Subjects Reporting Medically Significant Conditions (MSCs)|"Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.~MSCs were collected regardless of causal relationship to vaccination and intensity."|Throughout the study period (from Day 0 up to Month 12)|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1432091|NCT00996125|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.|During the 7 days (Days 0 – 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1432092|NCT00996125|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 7 days (Days 0 – 6) following each vaccination|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1432093|NCT00996125|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.|At Month 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available.|||Participants|||Count of Participants
1441660|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
1432095|NCT00996034|Primary|Mean of the Average Nicotine Binding % at Scan 1 and Scan 2|nAchR levels from baseline and after immunization with 3’-AmNic-rEPA (NicVAX=vaccine) SPECT images obtained in healthy control smoking subjects at baseline and after immunization with 3’-AmNic-rEPA (NicVAX=vaccine). nAchR levels will be determined by radioligand uptake in SPECT images. Means were calculated for all subjects at scan 1 and scan 2.|3 months||||percentage of average nicotine binding||Standard Deviation|Mean
1432096|NCT00995930|Secondary|Pharmacokinetics: ACZ885 Serum Concentrations|Blood samples were collected to analyze the ACZ885 serum concentrations.|pre-dose, 0.167 day post dose 1, 7 days post dose 1, 14 days post dose 1, every 30 days post each dose from doses 1 through 12, 60 days post dose 12, 90 days post dose 12|Only participants from the PK analysis set, who had evaluable data at each time point, were included in the analysis for that time point. The PK analysis set included randomized participants from the ACZ885 arm who received at least one dose of study medication.|||ng/mL||Standard Deviation|Mean
1432097|NCT00995930|Secondary|Change From Baseline Insulin Resistance (HOMA-IR)|Blood samples were collected to analyze insulin resistance. Insulin resistance was calculated by the Homeostasis Model Assessments of insulin resistance (HOMA-IR)) as follows: HOMA-IR: The product of basal glucose (mmol/L) and insulin (µU/mL) levels divided by 22.5 [i.e., HOMA-IR = basal glucose*basal insulin/22.5].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||IR score||95% Confidence Interval|Geometric Mean
1432098|NCT00995930|Secondary|Change From Baseline in Beta Cell Function (HOMA-B)|Blood samples were collected to analyze beta cell function. Beta cell function was calculated by the Homeostasis Model Assessments (of beta cell function (HOMA-B) as follows: HOMA-B: The product of 20 and basal insulin (µU/mL) levels divided by the value of basal glucose (mmol/L) concentrations minus 3.5 [i.e., HOMA-B = 20*basal insulin/(basal glucose-3.5)].|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||percentage of beta cell function||95% Confidence Interval|Geometric Mean
1432099|NCT00995930|Secondary|Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT)|Blood samples were collected to analyze the 2 hour glucose post OGTT.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||mmol/L||95% Confidence Interval|Geometric Mean
1432100|NCT00995930|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|Blood samples were collected to analyze HbA1c.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||percentage||95% Confidence Interval|Geometric Mean
1432101|NCT00995930|Secondary|Change From Baseline in Fasting Plasma Glucose|Blood samples were collected to analyze fasting plasma glucose.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||mmol/L||95% Confidence Interval|Geometric Mean
1432102|NCT00995930|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Blood samples were collected to analyze hsCRP.|baseline, 3 months, 12 months|Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication.|||mg/L||95% Confidence Interval|Geometric Mean
1432103|NCT00995930|Secondary|Change From Baseline in Aortic Strain|Arterial strain was computed directly from the cine SSFP images and the change in lumen diameters over the cardiac cycle. The value was independent of pulse pressure and is unitless ratio derived from the maximum to minimum lumen diameters diastole and systole, respectively..|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||ratio||Standard Error|Least Squares Mean
1432104|NCT00995930|Secondary|Change From Baseline in Plaque Composition|During the carotid MRI acquisition, in addition to the PD weighted ECG gated double inversion fast spin echo sequences T1 and T2 weighted sequences were acquired. In combination with the PD weighted images, the multi-contrast images were analyzed to determine regions of interest with contrast patterns consistent with the presence of necrotic lipid core, calcification and fibrous tissue in participants who had complex carotid plaque present in the bifurcation region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||mm^2||Standard Deviation|Mean
1432105|NCT00995930|Secondary|Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error|Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||ms^-1||Standard Error|Least Squares Mean
1432268|NCT00993824|Primary|Sleep Norm AUC Average by Group (Normalized)|Overnight glucose captured by CGM.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||mg/(dL/hr) normalized||Standard Deviation|Mean
1432106|NCT00995930|Primary|Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)|For assessment of atherosclerotic plaque burden of the aorta, vessel wall images of the aorta were acquired with an ECG gated double-inversion recovery (black blood) fast spin echo sequence applied breath-holding. Using an oblique sagittal image of the aorta as a pilot, serial axial images were acquired to cover a section of the descending thoracic aorta. The midpoint of the right pulmonary artery in cross section was used as the anatomical reference for the first slice in baseline and follow-up scans. For assessment of the atherosclerotic plaque burden in the carotids, vessel wall images were acquired with an axial ECG gated PD (proton density) weighted black blood sequence. The carotid bifurcation was used as the anatomical reference for all three imaging time points (baseline, 12 weeks, 48 weeks) with axial slice planes acquired below the bifurcation region. The mean values reported here for the carotid are reported for the proximal common carotid region.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||mm^2||Standard Error|Least Squares Mean
1432107|NCT00995930|Primary|Change From Baseline in Aortic Distensibility|Two axial, ECG-gated, steady state free precession (SSFP) ‘cine’ images were acquired during breath-hold to determine aortic distensibility. The first image was obtained at the level of the right pulmonary artery through the ascending and proximal descending aorta and the second through the distal aorta below the diaphragm. Imaging of the aorta also enabled evaluation of the plaque burden and additional vascular function measures.|baseline, 3 months, 12 months|Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication.|||mmHg^-1||Standard Error|Least Squares Mean
1432108|NCT00995930|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|12 months|Safety analysis set: The safety analysis set included all randomized participants who received at least one dose of study drug.|||Number of participants|||Number
1432109|NCT00995904|Primary|Half-life (t1/2) of Budesonide After Administration of MAP0020|Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.|12 hours|Patients with available data at specified time points are included in the analysis population.|||minutes||Standard Deviation|Mean
1432110|NCT00995904|Primary|AUC(0-inf) of Budesonide After Administration of MAP0020|The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.|||pg*min/ml||Standard Deviation|Mean
1432111|NCT00995904|Primary|Cmax of Budesonide After Administration of MAP0020|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).|12 hours|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Mean
1432112|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.~After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.~Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.~At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 22 up to 42 Days.|Subjects were to combined at days 22 to 42 . At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.|||participants|||Number
1432113|NCT00995865|Secondary|Distribution of Geometric Mean Antibody Titers (GMTs) to Yellow Fever 17D Virus.|Geometric mean antibody titers (GMT) neutralizing antibody titers for each dose groups.|GMT titers measured at days 21, 31 and 42 for different dose rates.||||Geometric Antibody titers||95% Confidence Interval|Geometric Mean
1432114|NCT00995865|Secondary|Percentage of Subjects With Seroconversions or Who Are Seropositive Using 2 Dose Levels of XRX-001|Secondary immunogenicity endpoints will use 2 dose levels of XRX-001 inactivated yellow fever vaccine determined by 50% plaque reduction neutralization test (PRNT50). Dose groups were to be compared for neutralizing antibody seroconverison rate, distribution of antibody titers, and geometric mean antibody titers (GMTs) to yellow fever 17D virus. The seroconversion rates and GMT neutralizing antibody titers for each dose group and all dose groups combined; The reverse cumulative distribution curve of antibody titers;|Days 21 and 42, 12 months|Seropositive was to show a significant level of serum antibodies, or other immunologic marker in the serum, indicating previous exposure to the infectious agent being tested. In immunology, seroconversion is the time period during which a specific antibody develops and becomes detectable in the blood.|||Percentage of subjects||95% Confidence Interval|Number
1432143|NCT00995553|Secondary|Functional Capacity - University of California, San Diego Performance-Based Skills Assessment|The UPSA is a measure of the ability to apply cognitive skills to functional tasks. The total score from this scale was used. Scores may range from 0 - 100, with higher scores being better.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1433108|NCT00987467|Secondary|Corticosteroid Usage|Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period|Entire follow-up period (Approximately 12 months)||||Total number of flare-up episodes|||Number
1432115|NCT00995865|Primary|The Incidence and Severity of Adverse Events in Each Treatment Group in the Double-blind Treatment Period up to 42 Days Post-vaccination.|"Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe.~After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42.~Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21.~At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures."|Measured from 0 up to 21 Days|Subjects were to return to the clinic on Days 3,10, 21, 24, 31,and 42 with the second vaccination given on Day 21. At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.|||participants|||Number
1432116|NCT00995774|Secondary|A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).||pre-treatment, post treatment|||||||
1432117|NCT00995774|Secondary|Action Research Arm Test|This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2||||units on a scale||Standard Deviation|Mean
1432118|NCT00995774|Primary|Fugl-Meyer Test of Motor Function|This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.|before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2||||units on a scale||Standard Deviation|Mean
1432119|NCT00995761|Primary|We Conducted the Present Phase II Study to Investigate the Efficacy and Safety of a Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable NSCLC.|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC (OS, TTP, and Others)|after every 2 cycles of docetaxel and cisplatin||2012-12-31|12/2012||||
1432120|NCT00995761|Secondary|Time to Progression and Overall Survival Confirmed Through Follow-up and Observation Following Treatment||From date of enrollment in this study until the date of first documented progression or date of death from any cause, whichever came first, after every 2 cycles of docetaxel and cisplatin|||||||
1432121|NCT00995761|Primary|Response Rates Confirmed With CT or MRI|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0."|after every 2 cycles of docetaxel and cisplatin|The sample size was calculated according to Simon's two-stage optimal design.The statistical evaluation was performed based on an ITT analysis. Descriptive statistics are reported as proportions and medians. OS and TTP were assessed by the K-M method, and the 95% CI for the median time to events was computed.|||percentage of participants||95% Confidence Interval|Number
1432122|NCT00995722|Secondary|Change in Quality of Life as Measured by the 10-Item Neuro-ophthalmological Supplement to the NEI-VFQ-25||4 months||||units on a scale||95% Confidence Interval|Mean
1432123|NCT00995722|Secondary|Change in Quality of Life as Measured by the MG-QOL-15 Score||4 Months||||units on a scale||95% Confidence Interval|Mean
1432124|NCT00995722|Secondary|Change in Quality of Life as Measured by the NEI-VFQ-25 Measures||4 months||||units on a scale||95% Confidence Interval|Mean
1432125|NCT00995722|Secondary|Change in Ocular Quantitative Myasthenia Score From Baseline to Week 16||4 months||||units on a scale||95% Confidence Interval|Mean
1432126|NCT00995722|Primary|Treatment Failure|Failure to achive sustatined minimal manifestation status by week 16|4 months||||percentage of participants||95% Confidence Interval|Number
1432127|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment|Patients number of occurences during a 24 week period.|24 weeks|Full analysis set|||Participants|||Number
1432128|NCT00995709|Secondary|To Observe the Effect of AIN457 on the Systemic Non-ocular Manifestations of Behçet’s Disease in Patients With Posterior Segment Uveitis Requiring Systemic Immunosuppression as Measured by the Bechet’s Disease Current Activity Form.|The BDCAF scores oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache according to the duration of symptoms. The presence and type of large-vessel and central nervous system (CNS) involvement are documented. Eye activity was deemed present if there was a history of blurring of vision or if the eye was painful or red. . The BDCAF score was calculated by adding the score of each index and ranged between 0 and 12 A reduction in score signifies a lessening of the disease.|baseline and wk 24 (end of study)|Full Analysis set|||change from baseline score||Standard Deviation|Mean
1432129|NCT00995709|Secondary|To Establish the Impact of AIN457 on Quality of Life of Posterior Segment Uveitis Patients Secondary to Behçet’s Disease Refractory to Systemic Immunomodulatory Therapy as Measured by National Eye Institute Visual Function Questionaire-25 and Euroqol.|The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. Scores range from 0 to 100, with higher scores indicating better visual function.|screening, and wk 24 (end of study)|Full Analysis Set|||Score||Standard Deviation|Mean
1432159|NCT00995345|Secondary|Percentage of Patients Achieving HbA1c Less Than 7%|Subjects Achieving Target of Hemoglobin A1c <7.0% at Week 24 with LOCF – Intent-to-Treat Population|24 weeks||||% of subjects in group|||Number
1432130|NCT00995709|Secondary|To Determine the Effect of AIN457 on Macular Edema and Visual Acuity in Patients With Posterior Segment Uveitis Secondary to Behçet’s Disease as Determined by Optical Coherence Tomography.|Optical coherence tomography (OCT) is amedical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media (e.g., biological tissue). OCT is based on low-coherence interferometry, typically employing near-infrared light. The use of relatively long wavelength light allows it to penetrate into the scattering medium. OCT is a noninvasive procedure that uses optical interferometry to visualize the structures within the retina. Following dilation of the pupil, a light source operating at 850nm provides probe illumination which is split and detected with and without the refraction of the retinal tissues. Cross-sectional imaging is accomplished in 1.3 second by acquiring a sequence of interferometric A-scans. A false color tomogram of optical reflectivity is produced by the computer. Central foveal thickness will be the primary variable derived from OCT. A increase in thickness could translate to disease progression.|baseline, and wk 24 (end of study)|(Full Analysis Set)|||change from baseline : micrometers||Standard Deviation|Mean
1432131|NCT00995709|Secondary|Change From Baseline for Composite Immunosuppressive Medication Score at Week 24 by Treatment (Full Analysis Set)|For each corticosteroid medication, dose of the corticosteroid was first converted to a prednisone-equivalent dose. To determine the prednisone equivalent dose, the corticosteroid dose was multiplied by a conversion factor. . The total prednisone equivalent dose was calculated as the sum of the prednisone equivalent doses of all corticosteroids. Consequently, the total converted prednisone equivalent dose was used to obtain the immunosuppressive score. The key secondary efficacy variable was the change in total post-baseline immunosuppressive medication score from baseline.The score is actually the prednisoone equivalents taken by patient as calculated by conversion table. A reduction in prenisone or prenisone equivalents is a positive outcome. An increase in the number of prednisone equivalents suggests that the treatment is not efficacious or that there is disease progression. A score of 0 would be the lowest ( no steriods taken) and the upper limit is indeterminate.|24 weeks|Full Analysis Set|||immunosuppressive medication score||Standard Deviation|Mean
1432132|NCT00995709|Primary|Rate of Recurrent Ocular Exacerbations in the Study Eye During 24 Weeks by Treatment||Baseline to week 24|Full Analysis Set|||Ocular Exacerbations||Standard Deviation|Mean
1432133|NCT00995670|Primary|Forearm Blood Flow|endothelial (forearm blood flow) responses to acetylcholine stimulation at baseline, and under conditions of high glucose before and after ischemia/reperfusion injury, and same with the addition of an intervention: sevoflurane (Arm 1), vitamin C (Arm 2), and high statin (Arm 3).|Baseline, Glucose Control, 15-min post ischemia||||ml/100 ml tissue/min||Standard Error|Mean
1432134|NCT00995566|Primary|Percentage of Participants Who Experienced Pulmonary Edema With the Presence of Veno-occlusive Disease|The criteria used to determine whether participants had both pulmonary edema and veno-occlusive disease was at the discretion of the Investigator.|Baseline up to year 1|FAS|||percentage of participants|||Number
1432135|NCT00995566|Primary|Bleeding AEs by Seriousness, Relationship to Treatment, Endothelin-A Receptor Antagonist (ERA) Usage, and International Normalized Ratio (INR) Results|Counts of participants who had bleeding events or treatment-emergent bleeding events, defined as newly occurring or worsening after first dose. Serious bleeding events reported from time of informed consent. Relatedness to Thelin assessed by investigator (Yes/No). ERA usage: was participant taking Vitamin K antagonist? (Yes/No). INR: participant's prothrombin time (PT) ratio. Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS|||participants|||Number
1432136|NCT00995566|Primary|Concomitant Medications|Number of participants with concomitant medication usage reported by drug categories.|Baseline, monthly up to 1 year|Data not summarized due to the small number of participants in database.|||participants|||Number
1432137|NCT00995566|Primary|Clinical Status Since Last Visit|Clinical status determined by status of pulmonary arterial hypertension (PAH) since last visit, reported as PAH remained stable, improved or deteriorated.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.|||participants|||Number
1432138|NCT00995566|Primary|Adverse Events (AEs) by Seriousness and Relationship to Treatment|Counts of participants who had AEs or treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Serious adverse events (SAEs) were reported from the time of informed consent. Relatedness to Thelin was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline up to year 1|FAS|||participants|||Number
1432139|NCT00995566|Primary|Duration of Exposure to Thelin|Time between the first and last dose of Thelin. For participants who continued Thelin from TOPS (another study), the initial TOPS’ Thelin start date was used.|1 Year|FAS|||months||Standard Deviation|Mean
1432140|NCT00995566|Primary|Percentage of Participants With Increases in Total, Conjugated and Non-conjugated Bilirubin Post-baseline|Total and conjugated bilirubin levels measured from blood, but indirect bilirubin calculated. Indirect bilirubin=Total bilirubin - Conjugated bilirubin. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.|||percentage of participants|||Number
1432141|NCT00995566|Primary|Percentage of Participants With a Decrease in Hemoglobin Post-baseline|Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Data not summarized due to the small number of participants in database.|||percentage of participants|||Number
1432142|NCT00995566|Primary|Percentage of Participants With Elevated Liver Function Post-baseline|Elevated liver function: greater than 3 times the upper limit of normal (>3 x ULN) alanine aminotransferase (ALT) and aspartase aminotransferase (AST) levels. Laboratory data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analyses.|Monthly up to 1 year|Full Analysis Set (FAS): participants enrolled in Patient Registry of Sitaxentan in Europe (PROSE). Number of participants analyzed (N): participants with evaluable data.|||percentage of participants|||Number
1432160|NCT00995345|Secondary|Change in Body Weight|Mean Change in Body Weight (kg) from Baseline to Week 24 with LOCF- ITT|24 weeks||||kg body weight on scale||Standard Error|Least Squares Mean
1433133|NCT00986999|Secondary|Change in Mitochondrial-specific Oxidative Stress (Mt-specific 8-oxo-dG) and Oxidative Phosphorylation (OXPHOS) Protein/Enzyme Activity [Complex I and Complex IV] Levels||3 months|||||||
1432144|NCT00995553|Primary|Cognitive Assessment - MATRICS Consensus Cognitive Battery|The Working Memory and Attention indexes of the MATRICS Consensus Cognitive Battery was used to assess near generalization of training with untrained tasks that were conceptually similar to training tasks. Each scale provide an age and gender corrected T-score. Thus, scores can range from 0-100, with a higher score indicating better performance.|Post-intervention, within 2 weeks of completion of the 4 month intervention|All participants who engaged in the intervention, defined as completing at least 3 sessions, were included in an Intent to Treat analysis. 80 of the 81 participants who started one of the study conditions met this definition of engagement. One participant who attended only 1 session of computer skills was excluded from the analysis.|||T-score||Standard Deviation|Mean
1432145|NCT00995501|Secondary|1 Year Mortality|All-cause mortality|1 year after surgery||||Participants|||Count of Participants
1432146|NCT00995501|Primary|Major Perioperative Morbidity|Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality.|30 day after surgery||||Participants|||Count of Participants
1432147|NCT00995488|Secondary|Median Overall Survival|The Median Overall Survival was captured in months.|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.|||months||95% Confidence Interval|Median
1432148|NCT00995488|Primary|Percentage of Participants With a Partial or Complete Response|"Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response [PR] + Complete Response[CR]) to therapy.~Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions.~Complete Response: Disappearance of all target lesions."|2 years|16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.|||percentage of participants||95% Confidence Interval|Number
1432149|NCT00995449|Primary|This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.|KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)|Weeks 14 & 30|This safety run-in portion of the study was conducted in a small cohort of 7 active (600 mg) and 2 placebo subjects.|||Participants|||Number
1432150|NCT00995436|Secondary|Patient Perception of the Different Treatment Methods, Including Surgical Experience||2 years|||||||
1432151|NCT00995436|Primary|Anchorage Loss Measured From 3-D Model Scanning||2 years||||mm||Standard Deviation|Mean
1432152|NCT00995410|Secondary|Most Frequent Treatment Emergent Adverse Events Leading to Study Drug Discontinuation|Most Frequent (≥ 1%) Treatment Emergent Adverse Events by System Organ Class leading to Discontinuation|12 months|Overall Safety Population. Events were collected by systematic assessment. One subject reported two adverse events leading to discontinuation from the study. SOC from vocabulary, MedDRA (12.1).|||participants|Participants||Number
1432153|NCT00995410|Primary|Number of Subjects Monitored for Long-term Safety of PA32540|Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).|12 months||||participants|||Number
1432154|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a ‘more limited’ life.~The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value"|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.|||units on a scale||95% Confidence Interval|Mean
1432155|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.|Baseline and 26 weeks After ESI to mild cross-over|Participants who reported Week 26 outcomes. All findings reported below for the ESI group are after cross-over to mild.|||units on a scale||95% Confidence Interval|Mean
1432156|NCT00995371|Primary|Mean Change in ODI|"Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a ‘more limited’ life.~The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value"|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported ODI at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.|||units on a scale||95% Confidence Interval|Mean
1432157|NCT00995371|Primary|Mean Change in VAS|Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 6 week value.|Baseline and 6 weeks prior to cross-over|All 38 participants (21 in mild and 17 in ESI arm) reported VAS at Week 6 post-treatment. All measurements for the ESI group occurred prior to cross-over to the mild procedure. This is Intent to Treat (ITT) analysis.|||units on a scale||95% Confidence Interval|Mean
1432158|NCT00995345|Secondary|Percentage of Patients Requiring Rescue Therapy for Elevated Glucose|Percentage of Subjects Requiring Rescue Therapy – Intent-to-Treat Population|24 weeks of treatment.||||% of subjects in group|||Number
1432161|NCT00995345|Primary|Change in HbA1c From Baseline (Week 0) to Week 24|Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)|Week 24|Conducted analyses of ITT population of change in HbA1c from baseline (Week 0) to Week 24. If the Wk 24 measurement was missing, the last valid post-baseline observation (LOCF) algorithm was used to impute Week 24 value (1 on-treatment value required). Efficacy data collected after the initiation of rescue therapy was excluded from the analyses.|||% HbA1c||95% Confidence Interval|Least Squares Mean
1432162|NCT00995085|Primary|Safety and Tolerability|Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug|24 hours after drug adminstration||||events|||Number
1432163|NCT00995020|Secondary|Time Spent to Perform the Procedure|Time was recorded from insertion until removal of the vaginal speculum.|Time spent from randomization to complete the procedure||||minuts||Standard Deviation|Mean
1432164|NCT00995020|Primary|Endocervical Margin Not Free of Disease.|Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.|3 months after the surgery is performed.|All data were analysed bu intention to treat.|||participants|||Number
1432165|NCT00995007|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|70 months and 19 days||||participants|||Number
1432166|NCT00995007|Secondary|Overall Survival|Time between the first day of treatment and the day of death.|Time between the first day of treatment and the day of death, up to 1.5 years|The group data is displayed per the report provided to the Food and Drug Administration.|||Months||95% Confidence Interval|Median
1432167|NCT00995007|Primary|Progression Free Survival at 6 Months|Percentage of participants who are alive and progression-free at 6 months.|6 months|The group data is displayed per the report provided to the Food and Drug Administration.|||percentage of participants|||Number
1432168|NCT00994929|Secondary|The Mechanism of Study Drug Effect by VWF mRNA.||within 11 days of study drug.||||fold increase||Full Range|Mean
1432169|NCT00994929|Secondary|The Frequency of Adverse Events||within 11 days of study drug||||participants|||Number
1432170|NCT00994929|Primary|Biologic Effects by Coagulation Tests|VWF activity was measured by ristocetin-induced platelet agglutination using a Chronolog aggregometer11-14 and VWF:Ag by “sandwich” ELISA, using anti-VWF antibodies (DakoA082, Carpintera CA). Results were expressed in percent, with normal human plasma pool designated 100%, and severe type 3 VWD plasma used as the negative control|within 4 days of study drug.|Four subjects had VWD and five subjects had mild hemophilia A|||percentage of normal||Standard Error|Mean
1432171|NCT00994760|Secondary|Caregiver: To What Extent the Treatment Needs of Your Patient Has Changed by the Use of Instanyl Regarding ...|Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more|after therapy with Instanyl (last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed'). N= number of valid cases"|||units on a scale||Standard Deviation|Mean
1432172|NCT00994760|Secondary|Caregiver: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values ('as observed') =N."|||units on a scale||Standard Deviation|Mean
1432173|NCT00994760|Secondary|Caregiver: Assessment of Breakthrough Pain Therapy by Instanyl (Last Visit)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|after therapy with Instanyl (first/last visit)|"Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat.~All patients with valid values ('as observed'). N= number of valid cases."|||units on a scale||Standard Deviation|Mean
1432174|NCT00994760|Secondary|Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with caregiver documentation (without imputation of missing values), ITT.~All patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
1432175|NCT00994760|Secondary|Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
1432176|NCT00994760|Secondary|Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)|5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases."|||units on a scale||Standard Deviation|Mean
1432177|NCT00994760|Secondary|Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed')."|||units on a scale||Standard Deviation|Mean
1432178|NCT00994760|Secondary|Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
1432179|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5|conspicuous score <1.5 inconspicuous score ≥1.5|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||participants|||Number
1432180|NCT00994760|Secondary|Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)|Scale: 0=worst, 5=best|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=93~Last Visit N=81"|||units on a scale||Standard Deviation|Mean
1432181|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20|"0= conspicuous ≤20~1= inconspicuous >20"|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||participants|||Number
1432182|NCT00994760|Secondary|Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)|Scale: 0=complete impairment, 43=no impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=93~Last Visit N=82"|||units on a scale||Standard Deviation|Mean
1432183|NCT00994760|Secondary|Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)|Scale: 0=no impairment, 70=complete impairment|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=92~Last Visit N= 80"|||units on a scale||Standard Deviation|Mean
1432184|NCT00994760|Secondary|Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?|Scale: 0=not at all, 10=completely|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=94~Last Visit N=83"|||units on a scale||Standard Deviation|Mean
1432185|NCT00994760|Secondary|Patient: How do You Feel Today?|Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good|before and after therapy with Instanyl (first/last visit)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases.~Initial Visit N=94~Last Visit N=83"|||units on a scale||Standard Deviation|Mean
1432186|NCT00994760|Secondary|Patient: Description of Pain at Initial Visit|0=no pain, 10= most intense pain imaginable|initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed') =N."|||units on a scale||Standard Deviation|Mean
1432187|NCT00994760|Secondary|Patient: How Many Episodes of Pain You Experience on Average?||initial visit (before start of therapy with Instanyl)|"All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit."|||episodes per day||Standard Deviation|Mean
1432188|NCT00994760|Primary|Physician: What is the Current Treatment Needs of Your Patient Regarding ...|Scale: 0=no, 1=low, 2=medium, 3=high|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||units on a scale||Standard Deviation|Mean
1432189|NCT00994760|Primary|Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)|Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened|after therapy with Instanyl (at last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N=number of valid cases."|||units on a scale||Standard Deviation|Mean
1432190|NCT00994760|Primary|Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)|5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
1432191|NCT00994760|Primary|Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)|Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed')= N."|||units on a scale||Standard Deviation|Mean
1432192|NCT00994760|Secondary|Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End|0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete|after therapy with Instanyl (planned: 4 weeks)|"Patients included and treated with valid data (without imputation of missing values), intention to treat.~All patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit."|||units on a scale||Standard Deviation|Mean
1432193|NCT00994760|Primary|Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination|Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme|before and after therapy with Instanyl (first/last visit)|"All patients included and treated, intention to treat, missing values not imputed.~All patients with valid values ('as observed'). N= number of valid cases."|||units on a scale||Standard Deviation|Mean
1432194|NCT00994760|Primary|Dose of Instanyl|Initially prescribed dose/ most efficient single dose of Instanyl at study end|during therapy with Instanyl (planned: 28 days)|"Patients included and treated (without imputation of missing values), intention to treat.~All patients included"|||participants|||Number
1432203|NCT00994682|Secondary|Skeletal Muscle Insulin Sensitivity|Rate of glucose disappearance (Rd) during high-dose insulin infusion. The rate of plasma glucose disappearance was calculated using Steele’s non-steady-state equation.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||mg/kgLBM/min||95% Confidence Interval|Mean
1432204|NCT00994682|Secondary|Adipose Tissue Insulin Sensitivity|Suppression of free fatty acids by low dose insulin (i.e., percentage of reduction of plasma FFA with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((plasma FFA without insulin - plasma FFA with insulin infusion)/plasma FFA without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||% of suppression of FFA||95% Confidence Interval|Mean
1432205|NCT00994682|Secondary|Hepatic Insulin Sensitivity|Suppression of endogenous glucose production (Supp EGP) by low dose insulin (i.e., percentage of reduction of EGP with low dose insulin infusion compared to the baseline state). This was calculated as: 100*((EGP without insulin - EGP with insulin infusion)/EGP without insulin). All measurements are obtained at the same time point during an euglycemic insulin clamp.|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||% of suppression of EGP||95% Confidence Interval|Mean
1432206|NCT00994682|Secondary|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Homeostatic model assessment of insulin resistance (HOMA-IR) is a method for assessing insulin resistance (IR) from basal fasting plasma glucose (FPG) and fasting plasma insulin (FPI). It is calculated as (FPG x FPI)/405.|18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||Arbitrary units||95% Confidence Interval|Mean
1432207|NCT00994682|Secondary|Liver Fat by Magnetic Resonance and Spectroscopy (MRS).|Liver fat content was calculated as the fat fraction: 100*(area under the curve [AUC] of fat peak / [AUC of fat peak + AUC of water peak]).|18 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group) and 83 at month 18 (42 and 41, respectively).|||percentage of fat in liver||Standard Deviation|Mean
1432208|NCT00994682|Secondary|Liver Transaminases (AST and ALT).||18 and 36 months|Data include 101 observations at baseline (51 in the placebo group and 50 in the pioglitazone group), 83 at month 18 (42 and 41, respectively), and 63 at month 36 (29 and 34, respectively).|||U/L||Standard Deviation|Mean
1432209|NCT00994682|Secondary|Mean Individual Histological Scores|Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis|Month 36||||units on a scale||95% Confidence Interval|Mean
1432210|NCT00994682|Secondary|Individual Histological Scores|"Number of patients with improvement of at least 1 grade in each of the histological parameters.~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal, 1A = Mild, zone 3, perisinusoidal delicate fibrosis; 1B = Moderate, zone 3, perisinusoidal dense fibrosis; 1C = Portal/periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis"|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||Participants|||Count of Participants
1432211|NCT00994682|Secondary|Mean Individual Histological Scores|Mean change in individual scores compared to baseline. Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis|Baseline and Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||units on a scale||95% Confidence Interval|Mean
1432212|NCT00994682|Secondary|Number of Participants With Resolution of NASH|Resolution of NASH was defined as absence of NASH after 18 months of therapy in patients with definite NASH (presence of zone 3 accentuation of macrovesicular steatosis of any grade, hepatocellular ballooning of any degree, and lobular inflammatory infiltrates of any amount) at baseline.|Month 18|Multiple imputation was used to impute missing histologic data for patients who did not complete 18 months of therapy.|||Participants|||Count of Participants
1432213|NCT00994682|Primary|Liver Histology (Using Kleiner et al Criteria, Hepatology 2005)|"Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0–3), hepatocellular ballooning (0–2) and lobular inflammation (0–3), and ranges from 0-8 .~The scoring system is based on the following grading:~Steatosis: 0 = <5%; 1 = 5-33%; 2 = >33-66%; 3 = >66%. Lobular Inflammation: 0 = No foci 1 = <2 foci/200x; 2 = 2-4 foci/200x, 3 = >4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis."|At 18 months||||Participants|||Count of Participants
1432214|NCT00994643|Primary|Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma|Patients were enrolled based on having obtained complete remission or at least a partial remission. Efficacy was therefore determined by the number of patients that remained in remission following treatment.|1 year||||Participants|||Count of Participants
1432215|NCT00994604|Secondary|Changes in Airway Size by Computed Tomography|Changes in size airways as measured by computed tomography|baseline and after two weeks||||size in mm^2||Standard Deviation|Mean
1432269|NCT00993824|Primary|Total Norm AUC Average by Group (Normalized)|Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||mg/(dL/hr) normalized||Standard Deviation|Mean
1432216|NCT00994604|Primary|The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract|"Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100~Bronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100"|baseline and two weeks||||index||Standard Deviation|Mean
1432217|NCT00994461|Secondary|Incidence of Treatment-emergent, All-causality GI Body System Adverse Events|The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
1432218|NCT00994461|Secondary|Number of Gastroduodenal Erosions in Each Subject|Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Participants|||Number
1432219|NCT00994461|Secondary|Number of Gastroduodenal Ulcers in Each Subject|Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Participants|||Number
1432220|NCT00994461|Secondary|Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)|Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Participants|||Number
1432221|NCT00994461|Secondary|Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions|The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
1432222|NCT00994461|Secondary|Incidence of Any Gastric, and Duodenal Ulcers|The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
1432223|NCT00994461|Primary|Incidence of Gastroduodenal Ulcers|The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.|2 weeks|The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.|||Percent|||Number
1432224|NCT00994448|Primary|Feasibility of Retaining Adolescents in Trial|the mean retention for participants is used to assess feasibility of retaining adolescents in the trial (completion = 56 days or 8 weeks)|8 weeks|mean days retained in treatment for each grou[p|||days||Standard Deviation|Mean
1432225|NCT00994422|Primary|Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|"Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator.~Severe scalp irritations were defined as follows:~Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - Large areas of the scalp are red; Severe Excoriation: Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp."|Day 1 up to Day 15 post-application|Local tolerability was assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
1432226|NCT00994422|Primary|Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)||Day 1 up to Day 28 post-application|Adverse events were assessed in the Intent-to-treat (Safety) population.|||Participants|||Number
1432227|NCT00994422|Primary|Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)|Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.|Days 2 up to Day 15 post-treatment|Treatment success was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of Participants|||Number
1432272|NCT00993668|Secondary|Percentage of All Subjects With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 216 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432228|NCT00994318|Primary|Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger|"Endpoint reported number of participants with/without events and was reached:~First time of initiation of additional or alternative anaemia management,~First time the subject reached the Hb trigger.~3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:~FCM (high ferritin target) compared with oral iron.~FCM (high ferritin target) compared with FCM (low ferritin target).~FCM (low ferritin target) compared with oral iron.~Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:~Without taking into account the Hb trigger.~Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory."|Up to 1 year after baseline|The Full Analysis Set (FAS) was used for the primary endpoint analysis, which consisted of all subjects randomised to treatment, received at least 1 dose of study treatment or, according to the protocol, were not treated due to ferritin value <100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment available.|||participants|||Number
1432229|NCT00994279|Secondary|Fatigue at 10 Weeks|FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.|10 weeks|Participants with 10 week outcome data. Note that one participant in the Wellness group was missing this outcome even though they completed the study.|||units on a scale||Standard Error|Least Squares Mean
1432230|NCT00994279|Primary|Retention|Proportion of participants completing the 10 week study|10 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1432231|NCT00994240|Primary|Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.|Clinical evidence of BCC recurrence post treatment|base line, every 3 months until 12 month completion|Study was terminated early due to lack of funding and slow enrollment. Biostatisticians determined insufficient data was available for statistical significance. Primary/lead protocol author is no longer at the institution and no data analysis is intended. Study has been closed with the local IRB and study files archived.|||participants|||Number
1432232|NCT00994214|Secondary|Number of Subjects Reported Adverse Events During the Study|"For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe > moderate > mild) and the most serious causality (related > not related) have been chosen.~TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study."|Up to Visit 10 (An average of 6.5 Months)|"Safety Population~Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received."|||Participants|||Number
1432233|NCT00994214|Secondary|Percentage Change in Ring Finger Circumference|Percentage change from Baseline at month X = (Ring finger circumference at month X – ring finger circumference at baseline) x 100 / ring finger circumference at baseline.|Baseline (Day 1) and Month 6|ITT population. N=Number of subjects attended Month 6 (visit 9).|||Percentage of Change in Ring Finger circ||Standard Deviation|Mean
1432234|NCT00994214|Secondary|Changes in IGF-1||Baseline (Day 1) and Month 6|ITT population|||Percentage of ULN||Standard Deviation|Mean
1432235|NCT00994214|Secondary|Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6|Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline|0-3 hr on Baseline (Day 1) and Months 1, 3 and 6|N=Number of patients randomised to treatment in IGF-1 <2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum.|||Percentage of change in mean GH||Standard Deviation|Mean
1432236|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 1|ITT population. N=Number of subjects attended Month 1 (visit 5).|||Percentage of subjects|||Number
1432237|NCT00994214|Secondary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 3|ITT population. N=Number of subjects attended Month 3 (visit 7).|||Percentage of subjects|||Number
1432238|NCT00994214|Primary|Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1||At Month 6|Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9).|||Percentage of subjects|||Number
1432239|NCT00994175|Primary|Baseline - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score|Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired|Baseline|All subjects who completed both treatment phases of the study|||units on a scale||Standard Deviation|Mean
1432240|NCT00994175|Primary|16 Weeks - Juniper Asthma Quality of Life Questionnaire (AQLQ) Score|Juniper Asthma Quality of Life Questionnaire (AQLQ) score at the end of the pioglitazone treatment period as compared to the placebo treatment period. The AQLQ is scored on a 7-point scale with 7 = not impaired at all, 1 = severly impaired|16 weeks|All subjects who completed both treatment phases of the study|||units on a scale||Standard Deviation|Mean
1432241|NCT00994123|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Erlotinib in Formalin Fixed (FFPE) Tumor Samples|Tumor tissue samples were obtained from patients prior to enrollment. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to erlotinib can increase PFS in HRG-high patients.|Time from first dose to date of progression, with a median of 8.1 weeks|Patients with available tissue for heregulin testing|||months PFS||95% Confidence Interval|Median
1432270|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens at Week 6 by Concomitant MTX Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432242|NCT00994123|Primary|Phase 2: Progression-free Survival of the MM-121 + Erlotinib Combination|"This was a time-to-event measure using Progression-Free Survival (PFS) comparing MM-121 + erlotinib vs.erlotinib alone. Progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of weeks from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, with a median of 8.1 weeks||||weeks||95% Confidence Interval|Median
1432243|NCT00994123|Primary|Phase 1: Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|"Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs.~The determined MTD was used as the recommended Phase 2 dose."|From date of first dose to 30 days after termination, the longest 175 weeks|All participants treated in the Phase 1 dose-escalation portion of the study|||dose level of MTD|||Number
1432244|NCT00994123|Primary|Phase 1: To Determine the Recommended Phase 2 Dose of the MM-121 + Erlotinib Combination Based Upon Either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose of the Combination in Patients With NSCLC.|To establish the safety of escalating doses of MM-121 in combination with erlotinib in order to determine the recommended phase 2 dose of the combination for the second part of the study. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 175 weeks||||participants reporting DLTs|||Number
1432245|NCT00994110|Primary|To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo.||60 days||||percentage of participants|||Number
1432246|NCT00993967|Other Pre-specified|Measures of Safety and Tolerability: Haematological and Biochemical Laboratory Parameters|Safety haematological analysis were done at every visit. Analyses included red blood cell count, haemoglobin, haematocrit, red cell indices, white blood cell count including differential, platelet count Safety biochemistry were done at every visit. Analyses included sodium, potassium, chloride, bicarbonate, urea, creatinine, calcium, inorganic phosphate, glucose, total bilirubin, total protein, albumin, aspartate amiotransferase (AST), alanine aminotransferase (ALT), alkaline phosphotase, Gamma GT, creatine kinase (CK)^, cholesterol, triglycerides, uric acid.|Month 1, 3, 6, 12, 18 and 24|||||||
1432247|NCT00993967|Other Pre-specified|Measures of Safety and Tolerability: Electrocardiograms (ECGs)|12-lead ECG recordings were performed at every visit. Each ECG was measured using 3 complexes: PR interval in lead II or V2, QRS and QT intervals and heart rate in lead II, corrected QT intervals QTcB and QTcF.|Month 1, 3, 6, 12, 18 and 24|||||||
1432248|NCT00993967|Other Pre-specified|Measures of Safety and Tolerability: Physical Examinations and Vital Signs|Assessment of the head, eyes, ears, nose, throat, heart, chest, lungs, abdomen, extremities, peripheral pulses, skin and any other physical conditions of note.|Month 1, 3, 6, 12, 18 and 24|||||||
1432249|NCT00993967|Primary|Absolute Change in The International Cooperative Ataxia Rating Scale (ICARS)|The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline, Month 12 and month 24|Changes in Total ICARS Score for all patients completing the study (CC Population)|||units on a scale||Standard Deviation|Mean
1432250|NCT00993967|Primary|Measures of Safety and Tolerability: Nature and Frequency of Adverse Events (AEs)|Global Overvbiew of accurance of AEs-Safety population. The Safety population included all subjects who received at least one dose of the study medication.|overall study, up to 24 months||||participants|||Number
1432251|NCT00993954|Secondary|Proportion of Patients With RHS Not Identified by Nurse Pathway.||End of enrollment||||participants|||Number
1432252|NCT00993954|Secondary|Proportion of Patients With Presentation Compatible With RHS, Have Reduction Attempted, Who Are Subsequently Diagnosed With Fracture.||Every 3 months during enrollment||||participants|||Number
1432253|NCT00993954|Secondary|Time to Discharge From ED (Minutes)||End of enrollment|2 missing data point in the physician group|||minutes||Full Range|Median
1432254|NCT00993954|Primary|Proportion of Patients With Successful Reduction of Radial Head Subluxation by Nurse, Compared With Physician Controls||10-15 minutes post reduction attempt||||percentage of patients reduced|||Number
1432255|NCT00993928|Secondary|Distress at Week 6|The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test.|From baseline to week 7|All patients that completed a Distress Thermometer assessment at baseline and week 7 were included in the analysis.|||percentage of change||Full Range|Median
1432271|NCT00993668|Secondary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens at Week 6 by Concomitant Methotrexate (MTX) Use.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1433134|NCT00986999|Secondary|Change in HIV Biomarkers of Immune Activation to Include CD38 and CD69 Expression on T Cells and CD16 and CD69 Expression on Monocytes||3 months|||||||
1432256|NCT00993928|Secondary|Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)|The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as “tense”, “angry”, “worn out”, etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient’s total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms.|At baseline and week 7|Patients that completed the POMS-B questionnaire at baseline and week 7 were used in this analysis.|||percentage of change||Full Range|Median
1432257|NCT00993928|Secondary|Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)|The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test.|Baseline and 7 weeks|Thirty-six patients from Arm A and 31 patients from Arm B had PSQI measurements available for analysis.|||percentage of participants|||Number
1432258|NCT00993928|Secondary|Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7.|"Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively: >~How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy) >~How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply) >~How many times did you awaken last night? >~How long did it take you to get to sleep last night? > > The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test."|Baseline and 7 weeks|In Arm A, 38 patients responded to questions during week 4 and 37 responded during week 7. In Arm B, 31 patients responded during week 4 and 30 responded during week 7.|||percentage of change||Full Range|Median
1432259|NCT00993928|Primary|Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7|"The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: How long did it take you to get to sleep last night? and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: When waking up after first falling asleep, how long did it take you to fall back to sleep? >~> Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test."|Baseline and 7 weeks|In Arm A, 4 went off treatment prior to week 7 and 2 had missing data. 23 patients were able to respond to question 6A. In Arm B, 7 did not finish 7 weeks of treatment and 1 patient had missing data. 16 patients responded to question 6A. Therefore, Q3 and Q6A are based on 37 and 23 patients in Arm A and 30 and 23 patients from Arm B, respectively.|||percentage change||Full Range|Median
1432260|NCT00993915|Other Pre-specified|Percent Change From Baseline in Lipid Parameters at 1 Month|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.||||||
1432261|NCT00993915|Other Pre-specified|Change From Baseline in Lipid Parameters at 1 Month|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified in registration for this outcome measure.||||||
1432262|NCT00993915|Secondary|Percent Change From Baseline in Lipid Parameters|Percent change from baseline calculated as: 100*(change at Month X)/(baseline value).|Month 6|FAS population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Percent change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.|||percent change||95% Confidence Interval|Mean
1432263|NCT00993915|Secondary|Change From Baseline in Lipid Parameters|Lipid parameters include HDL cholesterol, LDL cholesterol, total cholesterol, and total triglycerides. Change = Month 6 value minus baseline|Month 6|FAS Population. Number of participants analyzed (N) = participants with evaluable data; n = number of participants with evaluable data for the specific category. Change at Month 3 not analyzed; Month 3 visit not part of final protocol, time point erroneously identified for this outcome measure.|||mg/dL||95% Confidence Interval|Mean
1432264|NCT00993915|Secondary|Percentage of Participants Achieving LDL Level ≤ 100 mg/dL at the 1 Month Visit||Month 1|Not analyzed; LDL data not collected at 1 Month visit, time point erroneously identified for this outcome measure.||||||
1432265|NCT00993915|Primary|Percentage of Participants Achieving LDL Level Less Than or Equal to (≤) 100 mg/dL at the 6 Month Visit||Month 6|Full analysis set (FAS) population: all participants who received at least one dose of Atorvastatin (Liprimar) during the observation period and who had at least 1 post-baseline efficacy evaluation. Number of participants analyzed (N)= participants with evaluable data.|||percentage of participants||95% Confidence Interval|Number
1432266|NCT00993824|Primary|Hypoglycemia Percentage of Time <70 mg/dL Average by Group|Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM<70 mg/dL)|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||percentage of time <70 mg/dL||Standard Deviation|Mean
1432267|NCT00993824|Primary|Wake Norm AUC Average by Group (Normalized)|Wake glucose captured by continuous glucose monitoring (CGM).|2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.||||mg/(dL/hr) (normalized)||Standard Deviation|Mean
1433135|NCT00986999|Primary|Change in Flow Mediated Dilatation (FMD) of the Brachial Artery||3 months|Not analyzed||||||
1433136|NCT00986986|Secondary|HDL||12 weeks|||||||
1432273|NCT00993668|Secondary|Percentage of All Subjects With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432274|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Influenza Antibody Titers at Baseline With Protective Influenza Antibody Titers (≥1:40 in ≥ 2 of 3 Influenza Antigens) at Week 6.||Baseline, End of single blind period (week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers but with protective influenza antibody titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432275|NCT00993668|Secondary|Percentage of Subjects With no Previous Protective Pneumococcal Antibody Titers at Baseline With Protective Pneumococcal Antibody Titers (≥1.6 µg/ml in ≥ 3 of 6 of the Pneumococcal Antigens) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 180 were in the Per Protocol Set Pneumococcal (PPSP) population (90 Placebo, 90 CZP) without baseline protective titers. Of these 180 subjects 150 (75 Placebo, 75 CZP) had protective pneumococcal antibody titers and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432276|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 109 were in the Full Analysis Set Influenza (FASI) population (109 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432277|NCT00993668|Secondary|Percentage of All Subjects Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 217 were in the Full Analysis Set Pneumococcal (FASP) population (110 Placebo, 107 CZP), and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432278|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 169 were in the Per Protocol Set Influenza (PPSI) population (83 Placebo, 86 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432279|NCT00993668|Primary|Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6.||Baseline, End of single blind period (Week 6)|Of the 224 randomized subjects (114 Placebo, 110 CZP), 176 were in the Per Protocol Set Pneumococcal (PPSP) population (88 Placebo, 88 CZP) without baseline protective titers, and are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1432280|NCT00993655|Secondary|Overall Survival|Time from the day of randomization to death from any cause.|During the study with median follow-up of 33 months||||months||95% Confidence Interval|Median
1432281|NCT00993655|Secondary|Progression Free Survival|Time from the day of randomization until the time when first observation of disease progression (earliest of the dates of first CA125 which meets progression definition and first objective relapse or progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, has been documented or when death due to any cause has been observed.|During the study with median follow-up of 33 months|All patients randomized to the study|||months||95% Confidence Interval|Median
1432282|NCT00993655|Primary|9-month Progression Rate Post-randomization|It is defined as proportion of patients who had progressed at or before 9 months after randomization, i.e., the time from the randomization to the date when the first observation of disease progression (earliest of the date when the first CA 125 meets progression definition and the date of first objective relapse or progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, recorded) has been documented or when death due to any cause has been observed was less than or equal to 9 months.|9 months|All randomized patients|||Porportion of participants|||Number
1432283|NCT00993616|Other Pre-specified|Duration of Progression-free Interval for All Patients||up to 5 years|Please note: this outcome measure is not an endpoint as per the protocol document. Data will not be reported.||||||
1432284|NCT00993616|Primary|Progression Free Survival at 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|Every other cycle for 6 months|Eligible and treated patients|||percentage of participants|||Number
1432285|NCT00993616|Primary|Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0||Every cycle during treatment and 30 days after the end of treatment|Eligible and treated patients|||Participants|||Count of Participants
1432286|NCT00993616|Primary|Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1)|Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (version 1.1): Complete Response (CR) is disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Increasing Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest|From study entry, up to 5 years||||participants|||Number
1432287|NCT00993499|Secondary|Frequency of Patients With Possible Clinically-significant Abnormalities in Liver Enzymes or Total Bilirubin|Evaluation of laboratory parameters included assessment of the frequency of patients with ALT and AST elevations concurrent with elevated bilirubin and indicative of Hy’s law cases.|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
1432288|NCT00993499|Secondary|Percentage of Patients With Drug-related AEs|Percentage of patients with drug-related adverse events (AEs).|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
1432289|NCT00993499|Secondary|Occurrence of Adverse Events According to CTCAE, Version 3.0|Percentage of participants with adverse events according to highest Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
1432290|NCT00993499|Secondary|AUC of Sirolimus at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of sirolimus at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1432291|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Sirolimus at Steady State (Cmax,ss)|Maximum measured plasma concentration of sirolimus at steady state (Cmax,ss)|24 hours (h) 5 minutes (min), 24h, 23h, 22h, 20h, 18h, 16h, 5min before first afatinib administration and 144h, 311h 55min, 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h, 336h, 480h after first administration of afatinib|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1432292|NCT00993499|Secondary|AUC of Afatinib at Steady State Over the Dosing Interval τ (AUCτ,ss)|Area under the curve (AUC) of Afatinib at steady state over the dosing interval τ (AUCτ,ss) for afatinib.|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1432293|NCT00993499|Secondary|Maximum Measured Plasma Concentration of Afatinib at Steady State (Cmax,ss)|Maximum measured plasma concentration of Afatinib at steady state (Cmax,ss)|24 hours (h), 311h 55minutes (min), 312h, 313h, 314h, 315h, 316h, 317h, 318h, 320h and 336h after first administration of afatinib|Pharmacokinetic (PK) set which included all patients in the treated set who had taken at least 1 dose of study medication and for whom at least 1 valid blood or plasma concentration was available. No patients in the Afa40+Sir05 group had analyzable data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1432294|NCT00993499|Secondary|Exploratory Examination of EGFR Mutations (Exons 19, 20 and 21 and Others) in Serum/Plasma DNA and Tumour DNA.|"Exploratory examination of Epidermal growth factor (receptor)(EGFR) mutations (Exons 19, 20 and 21 and others) in serum/plasma DNA and tumour DNA.~This endpoint was not analysed in the study report as the available data was too limited."|Multiple time points during the trial|Treated set. This endpoint was not analysed in the study report as the available data was too limited.||||||
1432295|NCT00993499|Secondary|Rate of Disease Control|Rate of (unconfirmed) disease control defined as CR, PR, or stable disease (SD), according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
1432296|NCT00993499|Secondary|Objective Response|Rate of (unconfirmed) objective response, defined as complete response (CR) or partial response (PR) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
1432297|NCT00993499|Secondary|Best Overall Response|Best overall response (unconfirmed) according to RECIST v1.1|From first trial medication intake in the first treatment course until last trial medication intake plus 28 days, up to 367 days|Treated set|||Percentage of participants|||Number
1432298|NCT00993499|Primary|Occurrence of Dose Limiting Toxicities (DLT)|Number of participants with of dose limiting toxicities (DLT)|2 first cycles, 56 days|Treated set|||Participants|||Number
1432299|NCT00993473|Other Pre-specified|Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded during the nocturnal time period (between 23:00 and 07:00 hours).|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).|||mmol/L||Standard Deviation|Mean
1432300|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low FSBG (Individual Component of the Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low FSBG consisted of all low FSBG readings (values <70 mg/dL) performed at other times."|6 months|Same as for primary endpoint: mITT population.|||events per patient-year||Standard Deviation|Mean
1432301|NCT00993473|Post-Hoc|"Event Rate of All Confirmed Low CGMS Excursions (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"All confirmed low CGMS excursions consisted of all low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL."|6 months|Same as for primary endpoint: mITT population.|||events per patient-year||Standard Deviation|Mean
1432302|NCT00993473|Other Pre-specified|Blood Glucose Variability Based on All On-treatment CGMS Values|Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded over all CGMS placements.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).|||mmol/L||Standard Deviation|Mean
1432303|NCT00993473|Other Pre-specified|Percent of Blood Glucose (BG) Within the Range of 70 – 180 mg/dL (3.9-10 mmol/L)|Calculated for each patient as the percent of all on-treatment CGMS values falling within the range of 70 – 180 mg/dL (3.9 – 10 mmol/L) inclusive.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with on-treatment CGM values (1 patient from the Lantus group and 1 from the NPH group did not have on-treatment CGM).|||percent of CGMS values within the range||Standard Deviation|Mean
1432304|NCT00993473|Other Pre-specified|Number of Patients With Different Types of Hypoglycemia Events|Definitions of the different types of hypoglycemia events provided in the outcome measure description of the corresponding event rates.|6 months|Same as for primary endpoint: mITT population.|||participants|||Number
1432305|NCT00993473|Secondary|Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However 1 patient in the NPH group did not have baseline CGM value and 2 other patients (1 in the Lantus group and 1 in the NPH group) did not have on-treatment CGM values.|||mmol/L||Standard Deviation|Mean
1432306|NCT00993473|Secondary|Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit|Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit.|6 months|The population analyzed consisted of patients from the mITT population (as defined for primary outcome measure) with post-baseline HbA1c values. 2 patients from the Lantus group and 7 from the NPH group had no post-baseline HbA1c value.|||percentage of participants|||Number
1432307|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)|Assessed using an analysis of covariance (ANCOVA) model with treatment, and randomization strata (baseline number of CGM hypoglycemic excursions <0.5 events/24hours or ≥0.5 events/24 hours, and baseline HbA1c <8.5% or ≥8.5%) as fixed effects, and using the baseline value as covariate.|baseline, 6 months|Same as for primary endpoint: mITT population.|||percent HbA1c||Standard Error|Least Squares Mean
1432308|NCT00993473|Secondary|Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment||baseline, 6 months|Same as for primary endpoint: mITT population. However post-baseline HbA1c values were missing for 9 patients: 2 patients in the Lantus group and 7 in the NPH group.|||percent HbA1c||Standard Deviation|Mean
1432309|NCT00993473|Secondary|Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year|Participants|Standard Deviation|Mean
1432310|NCT00993473|Secondary|Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year||Standard Deviation|Mean
1432311|NCT00993473|Secondary|"Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of All Hypoglycemia Episodes Divided by the Total Duration of the On-treatment Period in Years"|Nocturnal hypoglycemia: any event from the “all hypoglycemia” total that occurred between 23:00 and 07:00 hours.|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year||Standard Deviation|Mean
1432312|NCT00993473|Secondary|Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years|Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe.|6 months|Same as for primary endpoint: mITT population.|||number of events per patient-year|Participants|Standard Deviation|Mean
1432313|NCT00993473|Secondary|Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)|Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries.|6 months|Same as for primary endpoint: mITT population.|||events per patient-year||Standard Deviation|Mean
1432314|NCT00993473|Primary|"Event Rate of All Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)"|"The rate of all hypoglycemia was calculated from all hypoglycemia episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL, - low FSBG readings (values <70 mg/dL) performed at other times."|6 months|The efficacy population consisted of all randomized patients who received at least one dose of the study medication (modified intent-to-treat [mITT] population). For efficacy analyses, patients were analyzed in the treatment group allocated by the Interactive Voice Response System (IVRS) at randomization (as randomized).|||number of events per patient-year||Standard Deviation|Mean
1432315|NCT00993447|Primary|Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited Systemic Reactions: Fever, ≥ 39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.|Day 0 up to Day 14 post-each vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
1433137|NCT00986986|Primary|Flow Mediated Vasodilation|Flow mediated vasodilation is a marker of endothelial function|12 weeks||||percentage change in FMD||Inter-Quartile Range|Median
1432316|NCT00993447|Primary|Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|"Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).~Flavivirus-naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain."|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1432317|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with < 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1432318|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (pre each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1432319|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1432320|NCT00993447|Primary|Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1432321|NCT00993447|Primary|Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
1432322|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.|||Percentage of participants|||Number
1432323|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.|||Percentage of participants|||Number
1432324|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (before each vaccination) and Day 28 post each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.|||Percentage of participants|||Number
1432339|NCT00993421|Secondary|Change in Total Cholesterol From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
1432325|NCT00993447|Primary|Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Percentage of participants|||Number
1432326|NCT00993447|Primary|Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.|||Percentage of Participants|||Number
1432327|NCT00993447|Primary|Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine|Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).|Day 0 (pre-each vaccination) and Day 28 post-each vaccination|Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
1432328|NCT00993421|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|Analysis of Cmax was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed due to the small sample size.|||nanograms per milliliter (ng/mL)||Standard Error|Geometric Mean
1432329|NCT00993421|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC)|Analysis of AUC was not conducted due to an inadequate number of samples collected.|4 weeks, 12 weeks, and 24 weeks|Zero participants were analyzed because of the low sample size.|||nanograms*hour per milliliter (ng*hr/mL)||Standard Error|Geometric Mean
1432330|NCT00993421|Secondary|Change in Insulin Resistance From Baseline to 24 Weeks Endpoint|Analysis of change in insulin resistance was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to inadequate number of samples.|||Units of Insulin/Day||Standard Deviation|Mean
1432331|NCT00993421|Secondary|Change in Fasting Insulin From Baseline to 24 Weeks Endpoint|Analysis of change in fasting insulin was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.|||micro Units/milliliter (μU/mL)||Standard Deviation|Mean
1432332|NCT00993421|Secondary|Change in Fasting Glucose From Baseline to 24 Weeks Endpoint|Analysis of change in fasting glucose was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to an inadequate number of samples.|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
1432333|NCT00993421|Secondary|Change in Glycated Hemoglobin A1c (HbA1c) From Baseline|Analysis of change in HbA1c was not conducted due to an inadequate number of samples.|Baseline, 24 weeks|Zero participants were analyzed due to the small sample size.|||percent glycated hemoglobin||Standard Deviation|Mean
1432334|NCT00993421|Secondary|Change From Baseline in Vitality Scale of Medical Outcomes Short Form - 36 (SF-36) Scale|Vitality change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body mass index was used as covariate. SF-36 is a self-reported questionnaire that consists of 36 questions covering 8 health domains including vitality. The vitality domain results are presented. The vitality domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1432335|NCT00993421|Secondary|Change From Baseline for Obesity Weight Loss Quality of Life Instrument (OWL-QoL)|Results presented as Least Squares Mean with treatment, visit, and their interaction as fixed effects, subject as random effect, baseline body mass index used as covariate. OWL-QoL consists of 17 items on scale ranging from 0 (Not at all) to 6 (A very great deal). Before calculating scores, each item is reversed. A single quality of life score is computed by summing each item and transforming this raw score onto standardized scale of 0 (greatest impact) to 100 (lowest impact) using formula: score = [(sum of component items score (minus) lowest possible score/ possible raw score range)*100].|Baseline, 24 weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
1432336|NCT00993421|Secondary|Change in Triglycerides From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
1432337|NCT00993421|Secondary|Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
1432338|NCT00993421|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to 24 Weeks Endpoint||Baseline, 24 weeks|Intent to Treat (IIT) population: all randomized participants who received at least one dose of study drug and received the intended study drug. Participants with baseline and at least one post-baseline measurement were included in the analysis (LOCF).|||millimole/Liter (mmol/L)||Standard Deviation|Mean
1432356|NCT00993291|Secondary|Gait Velocity|gait velocity measured as change from baseline in in CM/second|5 hours|||||||
1432340|NCT00993421|Secondary|Percentage Change in Waist Circumference From Baseline to 24 Week Endpoint|Percentage change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT|||percent change||Standard Deviation|Least Squares Mean
1432341|NCT00993421|Secondary|Change in Waist Circumference From Baseline to 24 Week Endpoint|Change from baseline to endpoint is presented as LSMEAN with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline waist circumference, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||centimeter (cm)||Standard Error|Least Squares Mean
1432342|NCT00993421|Secondary|Change in Body Composition Using Dual Energy X-ray Absorptiometry (DXA) From Baseline to 24 Week Endpoint|Change in body composition (lean body mass and fat mass) was assessed using dual energy x-ray absorptiometry (DXA) and is presented as LSMEAN values with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body composition, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||kilograms (kg)||Standard Error|Least Squares Mean
1432343|NCT00993421|Secondary|Change in Blood Pressure From Baseline to 24 Week Endpoint|Blood pressure change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline blood pressure, age, gender were used as covariates.|Baseline, 24 weeks|ITT|||mm Hg||Standard Error|Least Squares Mean
1432344|NCT00993421|Secondary|Change in Heart Rate From Baseline to 24 Week Endpoint|Heart rate change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline heart rate, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1432345|NCT00993421|Secondary|Percentage of Participants Who Achieve a Minimum of 10% Weight Loss From Baseline at 24 Weeks||24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||percentage of participants|||Number
1432346|NCT00993421|Secondary|The Mean Change in Body Weight From Baseline to 24 Week Endpoint|Body weight change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||kilograms||Standard Error|Least Squares Mean
1432347|NCT00993421|Primary|Percent Change in Body Weight From Baseline to 24 Week Endpoint|Body weight percentage change from baseline is presented as Least Squares Mean (LSMean) with treatment, visit, and their interaction as fixed effects, subject as a random effect, baseline body weight, age, gender were used as covariates.|Baseline, 24 weeks|ITT population: all randomized participants receiving at least 1 dose of the study drug according to the treatment the participants actually received. Participants with baseline and a measurement at endpoint were included in the analysis.|||percent change||Standard Error|Least Squares Mean
1432348|NCT00993317|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.|Baseline and Week 24|FAS population|||scores on a scale||Standard Deviation|Mean
1432349|NCT00993317|Secondary|ACR70 Responses at Week24||Week 24|FAS population|||participants|||Number
1432350|NCT00993317|Secondary|ACR50 Responses at Week 24||Week 24|FAS population|||participants|||Number
1432351|NCT00993317|Secondary|ACR70 Responses at Week 12|Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week12|FAS population|||participants|||Number
1432352|NCT00993317|Secondary|ACR50 Responses at Week 12|Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population|||participants|||Number
1432353|NCT00993317|Secondary|ACR 20 Responses at Week 12|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 12|FAS population|||participants|||Number
1432354|NCT00993317|Primary|ACR20 Responses at Week 24|Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient’s and physician’s global assessments, Patient’s assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.|Week 24|Full Analysis Set (FAS) Population The full set population will consist of all the subjects who were randomized and treated with the drug and received the primary efficacy evaluation at baseline. In the case of dosing administration error, analyses on the FAS population will be conducted according to the drug the subjects were randomized to.|||participants|||Number
1432355|NCT00993291|Secondary|Time to Walk 14 Meters|Change in the time to walk 14 meters compared to baseline measured in seconds|5 hours|||||||
1432358|NCT00993265|Secondary|National Institute of Mental Health –Trichotillomania Severity Scale (NIMH-TSS)|The National Institute of Mental Health - Trichotillomania Severity Scale (NIMH-TSS) assesses severity of hair pulling. The NIMH-TSS is a 6 item assessment, with total scores ranging from 0-20. Higher scores indicate greater severity/impairment.|Week 12||||units on a scale||Standard Error|Mean
1432359|NCT00993265|Secondary|The Milwaukee Inventory for Styles of Trichotillomania–Child Version|"The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses focused pulling, hair pulling that occurs intentionally to relieve tension or distress, and automatic pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the focused pulling subscale and 4 questions in the automatic pulling subscale. The scores range from 0-36 on the automatic pulling subscale and 0-189 on the focused pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style."|Week 12||||units on a scale||Standard Error|Mean
1432360|NCT00993265|Secondary|Trichotillomania Scale for Children - Parent Version|The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12||||units on a scale||Standard Error|Mean
1432361|NCT00993265|Secondary|Children's Depression Inventory|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12||||units on a scale||Standard Error|Mean
1432362|NCT00993265|Secondary|Multidimensional Anxiety Scale for Children (MASC)|The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety.|Week 12||||units on a scale||Standard Error|Mean
1432363|NCT00993265|Secondary|Trichotillomania Scale for Children - Child Version|The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.|Week 12||||units on a scale||Standard Error|Mean
1432364|NCT00993265|Primary|Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)|The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.|Week 12||||units on a scale||Standard Error|Mean
1432365|NCT00993200|Secondary|Thrombotic Complication|Number of thrombotic events|12 week||||number of thrombotic events|||Number
1432366|NCT00993200|Secondary|Adverse Major and Minor Bleeding Events|Number of major and minor bleeding events|12 week||||number of bleeding events|||Number
1432367|NCT00993200|Primary|The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range|The number of days to first International Normalized Ratio (INR) is being measured from initiation of warfarin to the time when a subject first has an INR lab test result within +/- 0.5 of mean target INR range. The period during which this time interval could be measured is any time during the subject's warfarin therapy.|variable as defined|analysis per protocol|||days||Standard Deviation|Median
1432368|NCT00993187|Secondary|Percentage of Participants With HbA1C < 7.0% at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).|Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.|||Percentage of Participants|||Number
1432369|NCT00993187|Secondary|Change From Baseline in Body Weight at Week 30|Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)|Baseline and Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.|||kg||95% Confidence Interval|Least Squares Mean
1432370|NCT00993187|Secondary|Percentage of Participants With One or More Episodes of Hypoglycemia|Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.|Up to Week 30|The APaT Population includes all randomized participants who received at least 1 dose of study medication.|||Percentage of participants|||Number
1432371|NCT00993187|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).|Baseline and Week 30|The FAS Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
1432372|NCT00993187|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 30 weeks|The APaT Population includes all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1432373|NCT00993187|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 32 weeks|The All Patients as Treated (APaT) Population includes all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1432374|NCT00993187|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).|Baseline and Week 30|Full-Analysis-Set (FAS) Population included all randomized participants who had a baseline measurement, consumed at least one dose of study medication, and had at least one post-randomization measurement.|||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
1432375|NCT00993148|Secondary|Proportion of Participants With Plasma HIV-1 RNA >50 Copies/mL|Proportion of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|96 weeks||||percentage of participants||95% Confidence Interval|Number
1432376|NCT00993148|Secondary|Median CD4 Count Change From Baseline|Median changes from baseline in peripheral CD4+ T-cell count|96 weeks||||cells per mm^3||Inter-Quartile Range|Median
1432377|NCT00993148|Secondary|Trough Concentrations (Ctrough) of Maraviroc|Average trough concentration (Ctrough) of maraviroc|24 hours||||ng/mL||Standard Deviation|Mean
1432378|NCT00993148|Secondary|Drug Adherence, Number of Participants With Missed Doses|Drug adherence, assessed as number of participants with missed doses over four-day recall|Week 24||||participants|||Number
1432379|NCT00993148|Secondary|Drug Resistance Mutations and Co-receptor Tropism Assessed by Trofile ES||At study entry and at the time of virologic failure||||participants|||Number
1432380|NCT00993148|Secondary|Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher|Signs/symptoms or laboratory toxicities of Grade 3 or higher, or of any grade which led to a permanent change or discontinuation of study treatment regimen|96 weeks||||participants|||Number
1432381|NCT00993148|Secondary|Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL|Percentage of participants with confirmed plasma HIV-1 RNA level >50 copies/mL|48 weeks||||percentage of participants||95% Confidence Interval|Number
1432382|NCT00993148|Secondary|Percentage of Participants With Virologic Failure or Off Study Treatment Regimen|Percentage of participants with virologic failure (confirmed plasma HIV-1 RNA > 50 copies/mL) or off study treatment regimen (composite end point)|24 weeks||||percentage of participants||95% Confidence Interval|Number
1432383|NCT00993148|Primary|Percentage of Participants With Plasma HIV-1 RNA >50|Percentage of participants with confirmed plasma HIV-1 RNA > 50 copies/mL|24 weeks||||percentage of participants||95% Confidence Interval|Number
1432384|NCT00993044|Primary|Dose Limiting Toxicity|Number of participants with dose limiting toxicity events|2 years||||participants|||Number
1432385|NCT00993031|Secondary|Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk After Pregnancy||Number of treatments given for clinical malaria based on postive blood smear from time from delivery until 24 months after delivery or cessation of breastfeeding||||treatments|||Number
1432386|NCT00993031|Secondary|Placental Malaria Defined Placental Histopathologic Analysis|Number of participants with positive placental histopathology slide for malaria|Delivery||||participants|||Number
1432387|NCT00993031|Secondary|Prevalence of Grade 3 or 4 Toxicity at Any Point During the Trial in the Two Treatment Groups in Women and in Infants||Time from randomization until 24 months postpartum or cessation of breastfeeding|||||||
1432388|NCT00993031|Secondary|ART Levels in Plasma and Hair Samples||Women at 30-34 weeks gestation and 12 weeks postpartum; Infants at delivery, 12 weeks and 24 weeks of life.|||||||
1432389|NCT00993031|Secondary|Incidence of Maternal to Child Transmission of HIV, Measured by Infant HIV DNA PCR||From delivery to 24 weeks of life or the cessation of breastfeeding if that occurs prior to 24 weeks of life|||||||
1432390|NCT00993031|Secondary|Development of One or More New Maternal HIV Antiretroviral Resistance Mutations||Measured at delivery and 24 weeks postpartum.|||||||
1432391|NCT00993031|Secondary|Change in Maternal CD4 Cell Counts and % CD4||From ART initiation to delivery and from delivery to the cessation of breastfeeding|||||||
1432392|NCT00993031|Secondary|Maternal HIV RNA Suppression of <400 Copies/mL and of <50 Copies/mL||At delivery and 24 weeks after the start of the treatment regimen||2017-12-31|12/2017||||
1432393|NCT00993031|Secondary|Incidence of Pre-eclampsia Defined by Hypertension > 140/90 on Two Occasions Measured > 6 Hours Apart With ≥1+ Proteinuria on Clean Catch Urine Dipstick||Time of randomization until 4 weeks postpartum||2017-12-31|12/2017||||
1432394|NCT00993031|Secondary|Prevalence of Composite Clinical Outcome Defined by LBW, Stillbirth(Intrauterine Fetal Demise >20wks GA), Late Spontaneous Abortion(Miscarriage 12-20wks GA), Preterm Delivery(<37wks Gestation), Neonatal Death(Death of Liveborn Infant Within First 28days)|Percent of evaluated participants with composite clinical outcome defined by LBW, stillbirth (intrauterine fetal demise >20wks GA), late spontaneous abortion(miscarriage 12-20wks GA), preterm delivery(<37wks gestation), neonatal death(death of live-born infant within first 28 days)|Time from randomization until 24 months postpartum or cessation of breastfeeding||||% of evaluated participants with outcome|||Number
1432395|NCT00993031|Secondary|Prevalence of Severe Maternal Anemia Defined by Hemoglobin < 8g/dl at Any Point During the Trial in Each Treatment Group|number of evaluated participants with severe maternal anemia defined by hemoglobin < 8g/dl at any point during the trial in each treatment group|Time from randomization until 24 months postpartum or cessation of breastfeeding||2017-12-31|12/2017||||
1432396|NCT00993031|Secondary|Maternal Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk During Pregnancy||Number of treatments given for clinical malaria based on postive blood smear from time from randomization until 24 months after delivery or cessation of breastfeeding||||treatments|||Number
1432397|NCT00993031|Secondary|Placental Malaria Defined as Positive Placental RDT|Number of participants with positive placental RDT for malaria. Malaria rapid diagnostic tests (RDTs) assist in the diagnosis of malaria by detecting evidence of malaria parasites (antigens) in human blood. RDTs permit a reliable detection of malaria infections particularly in remote areas with limited access to good quality microscopy services.|Delivery|Some participants did not have a placental specimen taken at delivery in the hospital (e.g. deliveries that occurred at home, missed by staff error, etc)|||participants|||Number
1432398|NCT00993031|Primary|Prevalence of Malaria Defined as Positive Placental Blood PCR|Number of participants with positive placental blood PCR for malaria|Delivery|Placental blood PCR|||participants|||Number
1432401|NCT00992992|Secondary|Number of Participants With an Adverse Event of Cytopenia|The effects of iodine I-131 tositumomab on the growth and function of hematopoietic progenitor cells was measured as the number of participants who had cytopenia. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Participants|||Number
1432402|NCT00992992|Secondary|Number of Participants Negative for Human Anti-Murine (Mouse) Antibody (HAMA) at Screening Who Converted to HAMA Positivity or Remained Negative During the Course of the Study|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured. Conversion to HAMA positivity is relative to Screening (participants were evaluable for HAMA analysis if they were HAMA negative at Screening).|Screening; at Week 7, Week 13, then every 6 months until disease progression or death (up to 143 months)|ITT-Exposed Population. Only those participants evaluable for HAMA were analyzed.|||Participants|||Number
1432403|NCT00992992|Secondary|Time to Recovery From the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to recovery to Baseline for the indicated hematologic parameters is defined as the time required for recovery from nadir values to Baseline values.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.|||Days||95% Confidence Interval|Median
1432404|NCT00992992|Secondary|Time to Nadir for the Indicated Hematology Parameters|Hematology parameters include ANC (calculated), hemoglobin, platelet count, and WBC count. Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Time to nadir is defined as the time from Baseline to the time the lowest value recorded following the therapeutic dose.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had data available.|||Days||Standard Deviation|Mean
1432405|NCT00992992|Secondary|Mean Nadir Values for Platelets and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had platelet and WBC data available.|||1000 cells/microliter||Standard Deviation|Mean
1432406|NCT00992992|Secondary|Mean Nadir Value for Hemoglobin|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had hemoglobin data available.|||grams/deciliter (g/dL)||Standard Deviation|Mean
1432407|NCT00992992|Secondary|Mean Nadir Value for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights infection.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only 24 participants had ANC data available.|||1000 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
1432408|NCT00992992|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs are defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; resulted in disability; or was a congenital anomaly. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Participants|||Number
1432409|NCT00992992|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, alternative therapy, or death.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Months||95% Confidence Interval|Median
1432410|NCT00992992|Secondary|Progression-free Survival|Progression-free survival is defined as the time from the start of treatment (i.e., the dosimetric dose) to the first documented disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must have been greater than 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population|||Months||95% Confidence Interval|Median
1432411|NCT00992992|Secondary|Duration of Response for Confirmed Complete Responders|Complete response is the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with confirmed CR were analyzed.|||Months||95% Confidence Interval|Median
1432412|NCT00992992|Secondary|Duration of Response for Unconfirmed Complete Responders|Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with unconfirmed CR were analyzed.|||Months||95% Confidence Interval|Median
1432413|NCT00992992|Secondary|Duration of Response for All Unconfirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defind as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants with an unconfirmed response (CR, CRu, or PR) were analyzed for duration of response.|||Months||95% Confidence Interval|Median
1432414|NCT00992992|Secondary|Duration of Response for All Confirmed Responders (CR + CRu + PR)|Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms. Complete response unconfirmed (CRu) is defined as CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow. Partial response (PR) is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. For participants with CR, CRu, or PR, duration of response is defined as the time from the first documented response to the first documented progression.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants (par.) with a confirmed CR, CRu, or PR were analyzed. The number of par. analyzed represents the par. with a confimed CR, CRu, or PR who also had the same response or a better response as confirmation (for example, a par. with an initial CRu and a subsequent CR has been included in the analysis).|||Months||95% Confidence Interval|Median
1432415|NCT00992992|Secondary|Number of Participants With the Indicated Confirmed Response (Confirmed Complete Response, Complete Response Unconfirmed, and Partial Response)|A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart. Participants with a confirmed response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 cm that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions). The individual rows for confirmed CR, confirmed CRu, and confirmed PR represent confirmation of the same response. For example, a confirmed CR indicates that a CR was followed by another CR at least 4 weeks later.|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population. Only those participants evaluable for response (those with at least one response assessment) were analyzed.|||Participants|||Number
1432416|NCT00992992|Primary|Number of Participants With the Indicated Unconfirmed Response (Complete Response, Complete Response Unconfirmed, and Partial Response)|Participants with response include those with complete response (CR: complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms), complete response unconfirmed (CRu: CR, with one of the following: residual lymph node mass >1.5 centimeters [cm] that has regressed by more than 75% in the sum of the product of the diameters or indeterminate bone marrow), or partial response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Every 13 weeks up to 2 years, or every 6 months until disease progression or death (average of 77.8 months)|ITT-Exposed Population: all participants who received any iodine I-131 tositumomab or CHOP treatment. Only those participants evaluable for response (those with at least one response assessment) were analyzed.|||Participants|||Number
1432417|NCT00992927|Secondary|Pain Measured by Visual Analogue Scale (VAS)|"before intervention for all participants~using 10cm horizontal visual analog scale~best: 0cm (no pain)~worst: 10cm (worst pain)"|1 month||||cm||Standard Deviation|Mean
1432418|NCT00992927|Primary|Range of Motion (ROM) of the Glenohumeral Joint|"before intervention for all participants~using a goniometer~patient sitting on a stool with the arm at anatomical position~worst: 0 degree~best: 360 degree"|1 month||||degree||Standard Deviation|Mean
1432419|NCT00992836|Secondary|Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens|"The TIV assay was not performed due to lack of available cells after completion of other planned assays.~The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10^6 peripheral blood mononucleated cell (PBMC).~The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10^6 PBMC.~The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10^6 PBMC."|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||SFC/10^6 PBMC||Inter-Quartile Range|Median
1432420|NCT00992836|Secondary|HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||titer||Inter-Quartile Range|Median
1432421|NCT00992836|Secondary|Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 peripheral blood mononucleated cell (PBMC) and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, 21 days after first dose, and 10 days after second dose|The participants who had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
1432422|NCT00992836|Secondary|Geometric Mean Antibody Titers (GMT) HAI|Presents the value of the geometric mean titer at each time point.|Measured after first and second doses and 6 months after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.|||titers||95% Confidence Interval|Geometric Mean
1432423|NCT00992836|Secondary|Percent of Participants With an HAI Titer >=40 at Long-term Follow-up||Measured at 6 months after second dose|The HAI titers were summarized for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.|||percentage of participants||95% Confidence Interval|Number
1432424|NCT00992836|Primary|Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640 and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and 10 days after second dose|The HAI titers following the first vaccination were summarized for the eligible study participants who received at least one vaccine and had nonmissing HAI data, and the titers following the second vaccination for the eligible study participants who received both doses of vaccine and had nonmissing HAI data.|||percentage of participants||95% Confidence Interval|Number
1432425|NCT00992836|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|The 154 study participants who received at last one vaccination are included in this analysis.|||participants|||Number
1432426|NCT00992836|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 7 months after vaccination|The 154 study participants who received at last one vaccination are included in this analysis.|||participants|||Number
1432427|NCT00992836|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|"Shows the number of participants who had at least one adverse event (AE) in each category. The AEs include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs.~Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death."|Measured up to 7 months after vaccination||||participants|||Number
1432428|NCT00992784|Secondary|The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180|The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 180 in subjects for whom data concerning immunogenicity were available for at least one test, 180 Days after vaccination.|||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
1432429|NCT00992784|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for cell mediated immunity (CMI) Day 21 in subjects for whom data concerning immunogenicity were available for at least one test, 21Days after vaccination.|||cells per million CD4+ T-cells||Standard Deviation|Geometric Mean
1432430|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||subjects|||Number
1432431|NCT00992784|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21|A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.|At Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||subjects|||Number
1432432|NCT00992784|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||fold increase||95% Confidence Interval|Geometric Mean
1432433|NCT00992784|Secondary|HI Antibody Seroconversion Factors (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||fold increase||95% Confidence Interval|Geometric Mean
1432434|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||subjects|||Number
1432435|NCT00992784|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||subjects|||Number
1432436|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||subjects|||Number
1432437|NCT00992784|Secondary|The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||subjects|||Number
1432438|NCT00992784|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 180 for whom data concerning immunogenicity at day 180 were available.|||titer||95% Confidence Interval|Geometric Mean
1432439|NCT00992784|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0 and Day 21|Analysis was performed on According-to-Protocol (ATP) cohort for humoral immunogenicity Day 21 for whom data concerning immunogenicity at day 21 were available.|||titer||95% Confidence Interval|Geometric Mean
1432440|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|After Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1432441|NCT00992784|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Up to Day 180|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1432442|NCT00992784|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1432443|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1432444|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||subjects|||Number
1432445|NCT00992784|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Days||Full Range|Median
1432446|NCT00992784|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||subjects|||Number
1432447|NCT00992784|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
1432448|NCT00992784|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||subjects|||Number
1432567|NCT00992186|Secondary|Maximum Observed Serum Concentration (Cmax)|The maximum observed analyte concentration was measured.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab.|||mcg/mL||Standard Deviation|Mean
1432449|NCT00992719|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to and at Day 21 post vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 21 following vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||participants|||Number
1432450|NCT00992719|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination as well as 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the vaccination and had blood collected at both timepoints, with 1 participant excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||participants|||Number
1432451|NCT00992719|Primary|Number of Participants Reporting Fever After Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post vaccination|All participants receiving the vaccination and who reported temperatures are included in the safety cohort. One participant did not report temperatures. Analyses are as treated.|||participants|||Number
1432452|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
1432453|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had cord blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.|||participants|||Number
1432454|NCT00992719|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Pregnant participants were included in the analyses if they had blood collected at delivery, with 1 participant excluded due to receipt of non-study vaccine. Participants were analyzed as treated.|||participants|||Number
1432455|NCT00992719|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
1432456|NCT00992719|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days post vaccination (Day 0-7)|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
1432457|NCT00992719|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after vaccination|All participants receiving the vaccination are included in the safety cohort. Analyses are as treated.|||participants|||Number
1432458|NCT00992719|Primary|Number of Births With Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All births are included in this outcome measure. Two participants gave birth to twins and two to triplets, each counted separately.|||births|||Number
1432459|NCT00992719|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.|||participants|||Number
1432460|NCT00992602|Secondary|Overall Survival||Time from start of therapy until death, assessed up to 4 years||||months||95% Confidence Interval|Median
1432461|NCT00992602|Primary|Survival Free of Neurological Progression, Measured in Weeks|Neurological progression defined by either clinical impression (measured by Karnofsky Performance Status), radiographical response (using Macdonald criteria), or cytologic response (measured by CSF cytology).|Time from start of therapy, assessed up to 4 years||||weeks||95% Confidence Interval|Median
1432462|NCT00992589|Primary|Change From Baseline in in Weekly Average I-GERQ-DD Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. Each of the 9 items will be assigned a numeric score. The total score will be calculated as the sum of all 9 items, and ranges from 0 to 37. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1432463|NCT00992589|Primary|Change From Baseline in I-GERQ-R Total Score (Double-blind Phase/ Baseline Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) is a 12-item questionnaire that is completed by the primary caregiver at every office or telephonic visit. It has a weekly recall and the items cover the frequency, amount and discomfort attributed to spit-up, refusal or stopping feeding, crying and fussing, hiccups, arching back and stopping breathing or changing color. The total score is calculated as the sum of all 12 scores for the individual questions, and ranges from 0 to 42. A higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1432464|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Eating Behavior Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Eating Behavior subscale score will be calculated as the sum of the 3 questions regarding eating behavior (Questions 4, 5, 6) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1432465|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Discomfort Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the subject has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Discomfort subscale score will be calculated as the sum of the 3 questions regarding discomfort (Questions, 7, 8, 9) and will range from 0 to 12. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1432466|NCT00992589|Secondary|Change From Baseline in Weekly Average I-GERQ-DD Regurgitation Subscale Score (Double-blind Phase/ Last Observation Carried Forward)|The Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) is a 9-item daily diary that the primary caregiver will be instructed to complete every evening at the same time interval after the participant has gone to sleep for the night. The I-GERQ-DD contains 3 subscales: the Regurgitation subscale, the Eating Behavior subscale and the Discomfort subscale. The Regurgitation subscale will be calculated as the sum of the 3 questions regarding regurgitation (Questions 1, 2, 3) and will range from 0 to 13. For each subscale score, a higher value indicates a worse outcome.|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1432467|NCT00992589|Secondary|The Daily Average Number of Episodes Related to Each Volume of Regurgitation During the Double-blind Treatment Period||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||number of episodes||Standard Deviation|Mean
1432484|NCT00992446|Primary|Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant|Number of patients on maintenance therapy post-transplant who experienced grade 3 or higher toxicity per NCI-Common Terminology Criteria for Adverse Events, version 3. The first three months of bortezomib and vorinostat therapy will be used as the time period to evaluate toxicity for stopping rules of the study. Toxicity that meets stopping rules will be determined based on the number of patients that are withdrawn from study for significant toxicity (grade IV, non-hematological, non-metabolic, non-peripheral neuropathy).|3 months after start of maintenance therapy||||Participants|||Count of Participants
1432468|NCT00992589|Primary|Change From Baseline in Weight-for-Age Z-Score (Double-blind Phase/ Baseline Observation Carried Forward)|Body weight was measured with the participant unclothed and before a feeding during each office visit. In the analysis of weight data, weight will be transformed to the weight-for-age Z-score using World Health Organization Child Growth Standards, taking into account the infant’s age and gender (Borghi E, 2006).|Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||Z-score||Standard Deviation|Mean
1432469|NCT00992589|Primary|Change From Baseline in Average Daily Frequency of Regurgitation (Double-blind Phase/ Baseline Observation Carried Forward)||Baseline, Week 8|Intent to Treat population, which consisted of all participants who completed the Open-label period, were randomly assigned to treatment in the Double-blind (DB) period, had taken at least 1 dose of DB study drug, and with evaluable data at each measurement time point.|||frequency of Regurgitation||Standard Deviation|Mean
1432470|NCT00992459|Secondary|U-PAGN24-hour Excr of NaPBA and HPN-100||24 hours on Day 14 of each treatments|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg||Standard Deviation|Mean
1432471|NCT00992459|Secondary|Cmax PAGN of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg/mL||Standard Deviation|Mean
1432472|NCT00992459|Secondary|Cmax for PBA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg/mL||Standard Deviation|Mean
1432473|NCT00992459|Secondary|Cmax for PAA of NaPBA and HPN-100 in Plasma|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μg/mL||Standard Deviation|Mean
1432474|NCT00992459|Secondary|Rate of Adverse Events in Each Treatment Group||29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.|||participants|||Number
1432475|NCT00992459|Secondary|Number and Severity of Symptomatic Hyperammonemic Crises|Severity of symptomatic hyperammonemic crises was measured by peak ammonia level (µmol/L) when it is >= 100 µmol/L.|29 Days|Safety population: (N=45 for NaPBA; N = 44 for HPN): Patients receiving any amount of NaPBA or HPN-100 comprise the Safety population. Safety population was to be used for safety analysis performed.|||events|||Number
1432476|NCT00992459|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA Versus HPN-100|NaPBA treated arm: total 345 blood samples were collected. HPN-100 treated arm: 343 blood samples were collected.|on Day 14 and Day 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||samples|blood samples||Number
1432477|NCT00992459|Secondary|Maximum Ammonia Values Observed on NaPBA Versus HPN-100|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||µmol/L||Standard Deviation|Mean
1432478|NCT00992459|Secondary|Correlation Between Urinary Phenylacetylglutamine (PAGN) Excretion Over 24 Hours (U-PAGN24-hour Excr) and Venous Ammonia - Area Under the Concentration-time Curve From Time 0 (Predose) to 24 Hours (AUC0-24)|The correlation between 24-hour urinary phenylacetylglutamine (PAGN) excretion (U-PAGN24-hour Excr) and venous ammonia AUC0-24 was summarized and the correlation was tested using the Spearman rank-order correlation.|28 Days|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this secondary endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||correlation coefficient|||Number
1432479|NCT00992459|Primary|The Primary Endpoint Was the 24-hour Area Under the Curve for Blood Ammonia (NH324-hour AUC) on Days 14 and 28.|Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. Arm A day 14 and Arm B day 28 data were combined as a NaPBA treatment Arm. Arm B day 14 and Arm A day 28 data were combined as a HPN-100 treatment Arm.|pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28|Intent-to-Treat (ITT) (N = 45): Patients receiving any amount of NaPBA or HPN-100 comprise the ITT population. ITT population was to be used for the primary analysis of this endpoint. One subject who withdrew from study after receiving one dose of NaPBA yielding N=44|||μmol∙h/L||Standard Deviation|Mean
1432480|NCT00992446|Secondary|Event-free Survival|(Not enough follow-up to report. 6/17/2018 is when this outcome measure will be met)|3 Years Post-Transplant|||||||
1432481|NCT00992446|Secondary|Overall Survival|(Not enough follow-up to report. 6/17/2018 is when this outcome measure will be met)|3 Years Post-Transplant|||||||
1432482|NCT00992446|Secondary|Ability to Complete Planned 12 Cycles of Maintenance Therapy|Number of patients who completed all 12 cycles of maintenance therapy.|Approximately 12 months following start of maintenance therapy||||Participants|||Count of Participants
1432485|NCT00992433|Primary|Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1432486|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1432487|NCT00992433|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
1432488|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1432489|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
1432490|NCT00992433|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1432491|NCT00992433|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. One participant did not record temperatures. Analyses are as treated.|||Participants|||Number
1432492|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post second vaccination (Day 0-7).|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1432493|NCT00992433|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days post first vaccination (Day 0-7).|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
1432494|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432495|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 and Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432496|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432497|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432498|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432499|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432500|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432501|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 10 after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432502|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432503|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1446881|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
1432504|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432505|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432506|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432507|NCT00992433|Primary|Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432508|NCT00992433|Primary|Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432509|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432510|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432566|NCT00992186|Secondary|Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)||Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.|||mcg*day/mL||Standard Deviation|Mean
1432511|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the second vaccination|Participants who received both H1N1 vaccinations in window and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432512|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432513|NCT00992433|Primary|Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 10 days after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to not meeting eligibility criteria at the time of enrollment. Analyses are as treated. This outcome restricts to CD4 stratum.|||Participants|||Number
1432514|NCT00992407|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score at Week 52|The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: ranging from 0 to 3), and a global clinical rating of akathisia (GCRA), ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Units on a scale||Standard Deviation|Mean
1432515|NCT00992407|Secondary|Change From Baseline in Simpson and Angus Rating Scale (SAS) Score at Week 52|The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Full Range|Median
1432516|NCT00992407|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score at Week 52|The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7.|Baseline and Week 52|"Safety analysis population included all randomized subjects who received risperidone injection or risperidone tablets at least once. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Full Range|Median
1432517|NCT00992407|Secondary|Change From Baseline in Number of Outpatient Clinic Visits at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 1 question is related to number of outpatient clinic visits. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||number of visits||Standard Deviation|Mean
1432518|NCT00992407|Secondary|Change From Baseline in Travelling Fee for Outpatients, Hospitalization Travelling Fee and Salary Paid a Participant Before Being Ill at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to travelling fee for outpatients, hospitalization travelling fee and salary paid a participant before being ill. Mean-calculations were done for all questions. Travelling fee, hospitalization travelling fee and salary paid were assessed for every past three months. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Won||Standard Deviation|Mean
1432519|NCT00992407|Secondary|Change From Baseline in Total Outpatients and Inpatients Hours at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 2 questions are related to total outpatients and inpatients hours. Total outpatients hours and total inpatient hours indicate the total hours spent by outpatients and inpatients respectively at Investigator site.Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||hours||Standard Deviation|Mean
1432520|NCT00992407|Secondary|Change From Baseline in Days of Hospitalization, Number of Days Affected by Participants and Family, at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 3 questions are related to days of hospitalization, number of days affected by participants and family per participant within reporting interval score. Mean-calculations were done for all questions. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||days||Standard Deviation|Mean
1432521|NCT00992407|Secondary|Change From Baseline in Members for Outpatients, Members Visiting Inpatients, Affected Members and Visiting Inpatients at Week 52|Healthcare economics questionnaire consists of 13-Questions, which measured disease burden on participant; out of which 4 questions are related to number of members for outpatients, number of members visiting inpatients, number of affected members and number of visiting inpatients. Mean-calculations were done for all questions. Higher value indicates more disease burden. Change from Baseline is the value at Week 52 minus value at Baseline.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||participants||Standard Deviation|Mean
1432522|NCT00992407|Secondary|Change From Baseline in Drug Attitude Inventory–10 (DAI-10) Score at Week 52|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. Score ranges from (-) 10 to 10. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1432523|NCT00992407|Secondary|Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Score at Week 52|The SUMD scale is a semi-structured scale that assesses participant's awareness of and insight into their illness, that is, the present level of insight. SUMD total score ranges from 0-27, with higher scores indicating poorer insight. The scale consists of nine items score ranging from 1 to 3, with higher scores indicating poorer insight. Score for each item is summed to produce the total score.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1432524|NCT00992407|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Test Score at Week 52|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1432525|NCT00992407|Secondary|Change From Baseline in Psychosocial Well-being Index (PWI) Score at Week 52|Psychosocial Well-being Index (PWI) is a questionnaire about how the participant feels and how the things had been going with them. Total score ranges from 0 to 135, where lower score indicates worsening.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1432526|NCT00992407|Secondary|Change From Baseline in Theory of Mind (TOM) Scale Score at Week 52|The TOM scale is used to assess the ability of participant to infer other's mental states. It includes recognition that other individuals experience thoughts, feelings, intentions, and desires. It is measured by cartoon task, score ranging from 0-30 and stork task which includes stork task set A (false belief), stork task set B (double bluff, white lie, persuasion, misunderstanding), and physical story, score ranging from 0-12, 0-26 and 0-24 respectively. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1432606|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432527|NCT00992407|Secondary|Change From Baseline in Continuous Performance Task (CPT) Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The CPT assessed CPT (Omissions) and CPT (Commissions). Omission errors indicate the number of times the target was presented, but the participant did not respond/click the mouse. High omission rates indicate that the participant is either not paying attention (distractibility) to stimuli or has a sluggish response. Commission errors indicate the number of times the participant responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors indicates inattention in general.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Errors||Standard Deviation|Mean
1432528|NCT00992407|Secondary|Change From Baseline in Working Memory Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. Working memory was assessed using Controlled Oral Word Association Test (COWAT) which measured verbal fluency and is a sub-test of the multilingual aphasia examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. More words indicate improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Words||Standard Deviation|Mean
1432529|NCT00992407|Secondary|Change From Baseline in Trail Making Test Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The Trail Making Test is composed of two Parts, A and B. Part A consists of 25 circles printed on a sheet of paper. Each circle contains a number from 1 to 25. The participant's task is to connect the circles with a pencil line as quickly as possible, beginning with the number 1 and proceeding in numerical sequence. Part B consists of 25 circles numbered from 1 to 13 and lettered from A to L. The task in Part B is to connect the circles, in sequence, alternating between numbers and letters. Here, mean number of seconds are represented required to complete each Part.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Seconds||Standard Deviation|Mean
1432530|NCT00992407|Secondary|Change From Baseline in Verbal Working Memory (VWM) Response Based on Neurocognitive Function Test (NCFT) at Week 52|The NCFT is neuropsychological test which measures psychological functions. The VWM was measured by Korean-Wechsler Adults Intelligence Scale (K-WAIS), which consists of two subscales, the Verbal scale (6 subtests) and the Performance scale (5 subtests). The verbal tests were: information, comprehension, arithmetic, digit span, similarities, and vocabulary. Arithmetic and Digit Span test of Verbal WAIS scales was conducted. Arithmetic test (arithmetic questions were asked orally) involved calculations that measured concentration while manipulating mental mathematical problems. Digit span test (children were asked to repeat the orally given sequences of numbers either as heard or in reverse order) measured attention, concentration, and mental control. Here, mean number of correct responses in limited time period are reported for arithmetic (calculation) and Digit span. Increase in number of correct response indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||Correct responses||Standard Deviation|Mean
1432531|NCT00992407|Secondary|Change From Baseline in Emotional & Social Functioning Scale (SFS) Score at Week 52|For emotional and SFS, mean scores of neuroticism-extroversion-openness (NEO) personality test, relationship style questionnaire (RSQ), state-trait anger expression inventory (STAXI), positive affect and negative affect schedule (PANAS), emotional intelligence (EI), beck depression inventory (BDI), and beck anxiety inventory (BAI) scales were calculated. Score ranges for each category as:60-300 for NEO, 30-150 for RSQ, 20-80 for STAXI, 20-100 for PANAS, 8-172 for EI, 0-63 for BDI and BAI. Higher score indicates improvement.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1432532|NCT00992407|Secondary|Change From Baseline in Social Functioning Scale (SFS) Score at Week 52|Social Functioning Scale (SFS) scores from 0 to 223 wherein, following categories were involved: Social Engagement (Score Range 0-15); Interpersonal Communication (Score Range 0-9); Recreational Activities (Score Range 0-45); Social Activities (Score Range 0-66; Independence Competence (Score Range 0-39); Independence Performance (Score Range 0-39); Occupational Activity (Score Range 0-10). Total score is sum of all sub scores and higher score indicates better level of social functioning.|Baseline and Week 52|"ITT population included all randomized participants who received at least one dose of study medication & fulfilled eligibility criteria. 'N' (number of participants analyzed) signifies participants evaluable for this measure.n signifies participants who were evaluated for this measure at specified timepoint for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1432533|NCT00992407|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 52|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
1432534|NCT00992407|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 52|ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
1432535|NCT00992407|Primary|Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 52|The PSP assesses degree of participant’s dysfunction within 4 domains of behavior, socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1=absent to 6=very severe) in each of 4 domains. Based on the 4 domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline and Week 52|Intent-to-treat (ITT) population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
1432536|NCT00992394|Secondary|Physician Global Assessment (PGA) of Disease Activity at Week 52|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Week 52|The modified intent-to-treat (mITT) population will be the primary efficacy population and will correspond to all randomized subjects who have a baseline PGA and at least one postbaseline PGA.|||Units on a scale||Standard Deviation|Mean
1432537|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): I Would Like to Continue With my Current Psoriasis Treatment, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432538|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Satisfied Were You With Your Psoriasis Treatment in General? at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432539|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Your Skin Affects Your Social and Leisure Activities, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432540|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): How Others Respond to Your Personal Appearance at Work/School, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432541|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Fatigue, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who has a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432542|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Depression, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432543|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Anxiety, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432544|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Your Comfort Level With Your Personal Appearance, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432545|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Joint Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432546|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Skin Pain, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432547|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Burning Sensation in the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432548|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Bleeding of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432549|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Tightness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432550|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Redness of the Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432551|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): Flaking Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of Participants|||Number
1432552|NCT00992394|Secondary|Patient Psoriasis Satisfaction Questionnaire (PSSQ): The Overall Appearance of Skin, at Baseline, Before Retreatment, and at the End of Retreatment|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: Very dissatisfied (0) to very satisfied (4), and never had this problem (5).|Baseline to Week 52|mITT population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Number of participants|||Number
1432553|NCT00992394|Secondary|Time-Normalized Area Under Curve (AUC) of Dermatology Life Quality Index (DLQI) at Week 52|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA.|||Units on a scale||Standard Deviation|Mean
1441661|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
1432554|NCT00992394|Primary|Time-Normalized Area Under Curve (AUC) of Physician Global Assessment (PGA) of Psoriasis Score at Week 52|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1. For participants who discontinued the study before week 52, the final PGA score was carried forward to the remaining time points before calculating the 52-week AUC. The AUC was calculated on the PGA score profile with the method of trapeziums from baseline visit to visit 52. The time-normalized AUC is defined as the ratio between AUC and the expected treatment period (days): AUC/ 52 weeks*7days + 1.|Week 52|The modified intent-to-treat (mITT) population was the primary efficacy population and corresponded to all randomized subjects who had a baseline PGA and at least one postbaseline PGA. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1432555|NCT00992264|Primary|Treatment Utilization for Smoking Cessation|confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program|12 months|Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment.|||% of participants using adjunct treatmen|||Number
1432556|NCT00992264|Primary|Smoking Abstinence|7 day point prevalent abstinence|12 months|Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample.|||percentage of abstinent participants|||Number
1432557|NCT00992225|Secondary|Maximum Concentration (Cmax)||After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)]|All participants who received at least one dose of the study drug.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1432558|NCT00992225|Secondary|The Percentage of Participants With Exposures in the Target Range|Exposure is the amount of drug the body sees in a period of time. Target range is an exposure thought to offer the optimal balance of safety and efficacy based on prior research.|After drug infusion in cycles 1 and 2 (5 samples drawn over each 28 day cycle)|All participants who received at least one dose of the study drug.|||Percentage of participants|||Number
1432559|NCT00992225|Secondary|Duration of Stable Disease|Duration of stable disease (SD) is defined from date of documented SD to first date of progressive disease (PD) or death from any cause (assessed every other cycle during study therapy, or every 2 months during post-therapy). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Time from documented Stable Disease (SD) to first date of progressive disease or death from any cause up to 12 months|All participants who received at least one dose of the study drug.|||months||90% Confidence Interval|Median
1432560|NCT00992225|Secondary|Duration of Overall Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to RECIST guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions.|Time of response to progressive disease or death up to 12 months|Zero participants analyzed. Duration of Overall Response for CR and PR data was not collected for analysis.||||||
1432561|NCT00992225|Secondary|Percentage of Participants Experiencing Clinical Benefit [(CR) + (PR) + Stable Disease (SD)]|Clinical Benefit Rate = [(CR) + (PR) + Stable Disease (SD)] of at least 4 cycles/N as classified by the investigator according to the RECIST guidelines, where N = total number of participants with at least one dose of study drug. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.|Baseline to measured progressive disease or death from any cause up to 12 months|All participants who received at least one dose of the study drug.|||percentage of participants||90% Confidence Interval|Number
1432562|NCT00992225|Secondary|Progression-free Survival|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Baseline to measured progressive disease or death from any cause up to 12 months|All participants who received at least 1 dose of the study drug.|||months||90% Confidence Interval|Median
1432563|NCT00992225|Primary|Percentage of Participants With an Objective Overall Response|Objective overall response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. It is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline to measured progressive disease or death from any cause up to 12 months|All participants who received at least one dose of study drug.|||percentage of participants||90% Confidence Interval|Number
1432564|NCT00992186|Other Pre-specified|Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Status Score|A worsening in ECOG performance status score was defined as greater than or equal to 1-point increase from Baseline. Time to worsening is defined as the number of days from first dose to the first day of worsening in ECOG score, or death, whichever occurred first. ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all selfcare, 3=Capable of limited selfcare, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no selfcare, totally confined to bed or chair, 5=Dead.|Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.|||Days||95% Confidence Interval|Median
1432565|NCT00992186|Secondary|Half-life (t1/2)|The time measured for the serum concentration to decrease by one half.|Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab except those whose serum samples were missing at the end of infusion.|||Days||Full Range|Median
1432607|NCT00991939|Primary|The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.||From 60 days through 365 days after study entry.||||percentage of subjects|||Number
1432568|NCT00992186|Secondary|Minimum Observed Serum Concentration (Cmin)||Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose|Analysis population included all the participants who received at least 1 administration of carlumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
1432569|NCT00992186|Secondary|Duration of Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.||||||
1432570|NCT00992186|Secondary|Time to Radiologic Response|Radiologic response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab. No data was available for this endpoint as no participant achieved CR or PR.||||||
1432571|NCT00992186|Secondary|Percentage of Participants With Pain Response|Pain response is defined as 2-point decrease from Baseline in ‘worst pain’ intensity score (item 3) on the Brief Pain Inventory (BPI) questionnaire. The BPI is a nine-item questionnaire with 0 to 10 numeric rating scales in response to each item, where 0=No pain and 10=Pain as bad as you can imagine. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab, had Baseline BPI ‘worst pain’ intensity score (item 3) more than or equal to 2, and at least 1 post-treatment pain evaluation. Participants with disease progression were considered to be evaluable, regardless of the post-dose evaluation.|||Percentage of participants|||Number
1432572|NCT00992186|Secondary|Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response|Urinary NTx response for participants with elevated NTx level at Baseline (more than or equal to 50 nanomole per millimole (nmol/mmol)) is defined as a 30% reduction from Baseline NTx value, confirmed by a second NTx value 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had elevated urinary NTx level at Baseline (more than or equal to 50 nmol/mmol) and at least 1 post-treatment urinary NTx measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1432573|NCT00992186|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|The PSA response for participants with elevated PSA levels at Baseline (more than or equal to 5 nanogram per milliliter (ng/mL) is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value measurement 3 or more weeks later.|Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a Baseline PSA more than or equal to 5 ng/mL and at least 1 post-treatment PSA measurement. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1432574|NCT00992186|Secondary|Overall Survival (OS)|The OS is defined as the time from the date of initiation of study treatment to death due to any cause. Participants were followed for 1 year after the last administration of carlumab for survival or until the end of study, whichever occurs first. For participants with unknown survival status as of the data cutoff date, OS was censored at the last date that the participant was known to be alive.|Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.|||Days||Full Range|Median
1432575|NCT00992186|Secondary|Progression-Free Survival (PFS)|The PFS is defined as the time from the date of initiation of study treatment to the date of initial documented skeletal or extra-skeletal progressive disease, or date of death, whichever occurs first. A participant is considered to have extra-skeletal disease progression if the disease has progressed as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria. A participant is considered to have skeletal disease progression if they have 1 post-baseline bone scan demonstrating 2 or more new skeletal lesions compared to Baseline and confirmed by a second bone scan 6 to 12 weeks later or with evidence of clinical progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab.|||Days||95% Confidence Interval|Median
1432576|NCT00992186|Secondary|Percentage of Participants With Objective Tumor Response|Objective response based on assessment of confirmed CR or PR according to RECIST. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had a measurable, non-measurable or bone lesion at Baseline and had at least 1 post-treatment tumor evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1433678|NCT00983580|Other Pre-specified|Gene Expression Analysis|Differences in log-transformed values among ACF or patient characteristics will be compared using t tests or analysis of variance (ANOVAs).|Baseline and 12 months|Data were not collected for this endpoint.||||||
1432577|NCT00992186|Primary|Percentage of Participants With Composite Response|The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values. A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.|Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab|Analysis population included all the participants who received at least 1 administration of carlumab and had at least 1 post-baseline disease evaluation. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1432578|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in Jaw Opening|maximum mandibular range of motion scores (measured as the maximum interincisal distance and compensating for occlusion)|baseline, 4 months|Participants completing the 4-month follow-up|||participants|||Number
1432579|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Pressure Pain Threshold|measurements were obtained by placing examiner’s index finger of the examiner on the area of the trigger point (hyperirritable areas on skeletal muscle with palpable taut bands of muscle fibers) and exerting pressure until there was whitening of the nail bed. Pressure pain levels were rated subjectively by the participant and coded numerically as mild (1), moderate (2) to severe (3).|baseline, 4 months|Participants completing the 4-month follow-up|||participants|||Number
1432580|NCT00992108|Secondary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|6 weeks||||participants|||Number
1432581|NCT00992108|Primary|Clinical Response as Assessed by >20% Change From Baseline in the Jaw Functional Limitation Scale (JFLS) Global Score|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation."|4 months|participants who completed the 4-month follow-up|||participants|||Number
1432582|NCT00992056|Primary|Change in 24-hour Mean Systolic Blood Pressure by ABPM From Day 5 of Low Sodium to Day 10 of High Sodium||Day 5, Day 10|24 subjects were randomized. Three withdrew informed consent during the study. One was withdrawn during the washout period. One completed all phases of the study but had a faulty ABPM reading on the last determination|||mmHg||95% Confidence Interval|Mean
1432583|NCT00992017|Secondary|Response to Seasonal Trivalent Influenza Vaccine (TIV)|Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at entry|Pregnant women who received the first H1N1 immunization.|||titer||Inter-Quartile Range|Median
1432584|NCT00992017|Secondary|Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values|The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10^6 PBMC and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10^6 PBMC.|Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose|The pregnant women who had not delivered prior to the evaluation, had received all doses of vaccine up to that timepoint and had sufficient samples for testing.|||ASC or SFC/10^6 PBMC||Inter-Quartile Range|Median
1432585|NCT00992017|Secondary|Infant GMT of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured at birth and at 3 and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.|||units on the HAI titer scale||95% Confidence Interval|Geometric Mean
1432586|NCT00992017|Secondary|Maternal Geometric Mean Titers (GMT) of Antibodies HAI|Presents the value of the geometric mean titer at each time point. Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280.|Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery|The population consists of eligible women with nonmissing HAI titers, who had not delivered before the evaluation post first or second dose, and received all vaccines up to that point, respectively. The N for analyses after the first and second vaccinations, at delivery, 3 and 6 months after were 104, 94, 102, 92 and 58, respectively.|||titers||95% Confidence Interval|Geometric Mean
1432587|NCT00992017|Secondary|Percent of Infants With an HAI Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at birth (via cord blood) and at 3 months and 6 months of age|The population consists of infants born to eligible women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for analyses at birth, 3 and 6 months were 96, 87 and 52, respectively. Cord blood was used when available. Only some infants had a clinic visit at 6 months.|||Percent of participants||95% Confidence Interval|Number
1432608|NCT00991887|Primary|Mayo Elbow Performance Score|Mayo Elbow Performance Score (MEPS) is an outcome tool based on a 100 point scale, with higher score indicating better function. It measures pain, stability, function, and motion. The score is graded on the basis of the MEPS as excellent (>=90), good (75-89), fair (60-74), and poor (<60).|6 month|Patients with elbow trauma treated with radiation therapy in the prevention of post-traumatic heterotopic ossification. Subjects are randomized to either radiation therapy or no radiation therapy.|||units on a scale||Standard Deviation|Mean
1432588|NCT00992017|Secondary|Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at delivery of the baby, and at 3 months and 6 months after delivery|The population consists of eligible pregnant women with nonmissing HAI titers, who had not delivered before the evaluation post second dose, and received two doses of vaccine. The N for the analyses of HAI titers at delivery, and at 3 and 6 months after were 102, 92 and 58, respectively. Only some women had a clinic visit at 6 months post delivery.|||Percent of participants||95% Confidence Interval|Number
1432589|NCT00992017|Primary|Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40|Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were <10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and >=1280. Seroprotection was defined as having a titer of >=40 following vaccination.|Measured at 21 days after first dose and at 10 days after second dose of study vaccine|The analysis population consists of the eligible pregnant women with nonmissing HAI titers, who had not delivered prior to the evaluation, and had received all doses of vaccine up to that timepoint. The N for the analyses of HAI titers after the first and second vaccinations were 118 and 108, respectively.|||Percent of participants||95% Confidence Interval|Number
1432590|NCT00992017|Primary|Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose||Measured at Day 21|All 128 pregnant women who received at least one vaccination are included.|||Participants|||Number
1432591|NCT00992017|Primary|The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine|Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included.|||Participants|||Number
1432592|NCT00992017|Primary|The Number of Participants Who Had at Least One Adverse Event (AE)|Shows the number of participants who had at least one adverse event (AE) in each category. These include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.|Measured up to 6 months after delivery|All 128 pregnant women who received at least one vaccination are included in this analysis.|||Participants|||Number
1432593|NCT00991952|Primary|Overall Response Rate|Response was determined as indicated in the protocol.|From the start of treatment for up to 3 months||||participants|||Number
1432594|NCT00991939|Secondary|The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy||Through 1 year after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432595|NCT00991939|Secondary|The Percentage of Patients Not Completing Study Therapy||49 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432596|NCT00991939|Secondary|The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432597|NCT00991939|Secondary|Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey||Weeks 4, 8, and 52 after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432598|NCT00991939|Secondary|The Percentage of Patients Undergoing Splenectomy||Through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432599|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432600|NCT00991939|Secondary|The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432601|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry||From 60 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432602|NCT00991939|Secondary|The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry||Through 60 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432603|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432604|NCT00991939|Secondary|The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry||From 180 days through 365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1432605|NCT00991939|Secondary|The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365||365 days after study entry|Due to the same sample size at the time that the study was terminated, this endpoint was not analyzed.||||||
1441662|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
1432609|NCT00991809|Secondary|Pain Threshold|The amount of time (in seconds) before the participant first verbally reports feeling pain after placing hand in 4 degree Celsius circulating water bath at the 30 minute time point. Truncated at 300 seconds for safety purposes.|8 sessions over 4-6 weeks|One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.|||seconds||Full Range|Mean
1432610|NCT00991809|Primary|Pain Tolerance|The participant places their hand in a water bath kept at 4 degrees Celsius (cold pressor test). They then continue to hold the hand in the water bath until they can no longer tolerate the pain (pain tolerance) or until the end of the testing (truncated at 300 seconds for safety purposes). Reported as the mean (time to hand removal in seconds) at the 30 minute time point.|8 sessions over 4-6 weeks|One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.|||seconds||Full Range|Mean
1432611|NCT00991510|Secondary|Summary of Participants With Adverse Events|"Summary of adverse events across three study time periods. The on-treatment time frame spanned the time during which study drug was administered. Relation to study drug was assessed by the investigator.~The Adverse Event count includes serious and non-serious AEs. A serious AE (SAE) was any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect or was an important medical event could have jeopardized the patient's safety or required medical or surgical intervention to prevent one of the outcomes listed above.~Severity was measured on a three-point scale: mild, moderate, severe."|Day 1 up to Day 112|Safety population. One participant discontinued the study prior to Period II so the Myfenax # participants analyzed is one less than the CellCept arm.|||participants|||Number
1432612|NCT00991510|Secondary|Time Corresponding to Occurrence of Cmax (Tmax) of Mycophenolate Mofetil|Tmax was directly obtained from measured values.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||hours||Standard Deviation|Mean
1432613|NCT00991510|Secondary|Degree of Fluctuation of the Concentration Levels of Mycophenolate Mofetil Over One Dosing Interval (PTF)|PTF was calculated as: (Cmax-Cmin)/(AUCt/t)*100|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||percentage of AUC for a dosing interval||Standard Deviation|Mean
1432614|NCT00991510|Secondary|Plasma Concentrations of Mycophenolate Mofetil in Pre-Administration Samples (Cpd)|Cpd was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||µg /ml||Standard Deviation|Mean
1432615|NCT00991510|Secondary|Minimum Observed Plasma Concentration (Cmin) of Mycophenolate Mofetil|Cmin was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||µg /ml||Standard Deviation|Mean
1432616|NCT00991510|Primary|Maximum Observed Plasma Concentration (Cmax) of Mycophenolate Mofetil|Cmax was directly obtained from measured values of plasma concentrations.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||µg /ml||Standard Deviation|Mean
1432617|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-tau)) of Mycophenolate Mofetil|For participants with a 0-12h profile: Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 12 hours). For participants with a 0-6h profile: AUC(0-tau) was calculated based on AUC(0-6h) using the extrapolation formula according to Fleming.|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||hour* µg /ml||Standard Deviation|Mean
1432618|NCT00991510|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-6h)) of Mycophenolate Mofetil|Area under the plasma concentration-time curve during a dosage interval at steady state (calculated using the trapezoidal rule, from t = 0 to t = 6 hours).|Day 14 and Day 28 (end of first two cross-over periods) before drug administration and at 30 min, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after drug administration|PK population. Two participants were excluded from the PK population: one dropped out of the study during the first period so had no PK samples. The other was omitted due to protocol violations.|||hour* µg /ml||Standard Deviation|Mean
1432619|NCT00991458|Secondary|Worst Outcome Post-LASIK Surgery in Reading Speed Assessment|Reading speed is determined using the MNREAD™ Reading Card. The MNREAD™ reading card is designed to simulate a normal every day reading scenario using binocular vision (both eyes at the same time). The MNREAD™ Reading speed is calculated as (60) X [Number of words on card - (reading errors)]/ (number of seconds until the card is read). The worst outcome is defined as the smallest number of words per minute across post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.|||Words Per Minute (WPM)||Standard Deviation|Mean
1432631|NCT00991341|Secondary|Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||mg/dL||Standard Deviation|Mean
1432620|NCT00991458|Secondary|Percentage of Patients With Cumulative Poor Vision|Cumulative Poor Vision is determined binocularly per patient (using both eyes at the same time) from the Poor Vision question on the Ocular Surface Disease Index (OSDI) questionnaire. Severity of poor vision is graded on a 5-point scale (0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, 4 = all of the time). Cumulative poor vision is defined as at least one poor vision score ≥ 1 beginning at Month 3 post-LASIK.|Month 3, Month 4, Month 5, Month 6|Intent to treat: all randomized patients.|||Percentage of Patients|||Number
1432621|NCT00991458|Secondary|Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment|The time to the worst outcome post-LASIK surgery in tear film stability is assessed using the Ocular Scatter Index (OSI). The OSI is calculated by an instrument which takes images of the eye over time. OSI values ≥3.0 indicate lower tear film quality resulting in a loss of visual acuity. The worst outcome post-LASIK surgery is defined as the shortest time to OSI ≥3 across both eyes and post-LASIK surgery months 3 to 6.|Months 3 to 6|Intent to Treat population: all randomized patients for whom data are available for this outcome measure.|||Seconds||Standard Deviation|Mean
1432622|NCT00991458|Primary|Time to Cure|Time to cure is defined as the number of days after laser in situ keratomileusis (LASIK) surgery that the patient has corneal sensitivity (the capability of the cornea to respond to stimulation) ≥ 50 millimeters in all 9 regions of both eyes after LASIK surgery. A patient is considered cured at the first of 2 consecutive visits meeting these criteria. The Inter-Quartile Range presented is actually the 25th Quantile and the 75th Quantile obtained from the Kaplan-Meier Model.|6 Months|Modified Intent to Treat: all randomized and treated patients with both eyes having Post-LASIK surgery and corneal sensitivity measurements of < 25 mm in the 3 central regions at Post-Surgery Week 1.|||Days||Inter-Quartile Range|Median
1432623|NCT00991341|Secondary|Any Mechanical Ventilation More Than 48 Hours Post-operation||48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
1432624|NCT00991341|Secondary|Days Alive and Ventilator Free Through Post-op Day 28||Through post-op day 28|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||days||Standard Deviation|Mean
1432625|NCT00991341|Secondary|Days to First Solid Food|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative solid food.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.|||days||Standard Error|Mean
1432626|NCT00991341|Secondary|Days to First Bowel Movement|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative bowel movement.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96). The mean time to an event is estimated by the area under the survival function.|||days||Standard Error|Mean
1432627|NCT00991341|Secondary|Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT. Therefore, to protect patient confidentiality, results were not entered.||||||
1432628|NCT00991341|Secondary|Change in Bilirubin From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||mg/dL||Standard Deviation|Mean
1432629|NCT00991341|Secondary|Change in Lactate From Pre-operative Value to Worst Post-operative Value|The arterial lactate levels were adjusted to make them comparable to venous lactate levels.|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||mmol/L||Standard Deviation|Mean
1432630|NCT00991341|Secondary|Change in Troponin-I From Pre-operative Value to Worst Post-operative Value||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||ng/mL||Standard Deviation|Mean
1432632|NCT00991341|Secondary|Ventilation Duration|Because some subjects may experience multiple periods of ventilator use, the total duration that they were on a ventilator was compared between the two groups.|Through post-operative day 28, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||days||Standard Deviation|Mean
1432633|NCT00991341|Secondary|Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
1432634|NCT00991341|Secondary|Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
1432635|NCT00991341|Secondary|Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)||Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
1432636|NCT00991341|Secondary|Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.|The follow-up MODS used to calculate 28-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 28, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 28-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through 28 days post-surgery, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||MOD score points||Standard Deviation|Mean
1432637|NCT00991341|Secondary|All-cause Mortality|Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.|28 days post-surgery|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||participants with event|||Number
1432638|NCT00991341|Primary|The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.|The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject’s worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).|Through post-operative day 7, hospital discharge, or death, whichever occurs first|Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).|||MOD score points||Standard Deviation|Mean
1432639|NCT00991302|Secondary|Cumulative Probability of First Grade 3 or 4 Adverse Events (AEs)|"The Kaplan-Meier estimate of the cumulative probability of experiencing a grade 3 or 4 adverse event by week 72.~New Grade 3 or 4 signs, symptoms were identified by MedDRA preferred term. Events were included regardless of participant status on ART. If a participant had multiple reports of the same event, only the event reported at the highest grade were included.~Time was measured from the study entry until the date of the first new grade 3 or 4 adverse event. Participants lost to follow-up prior to reaching an adverse event endpoint or not documented to have reached an adverse event endpoint at the end of the study had their endpoint censored at the date of their last visit."|From study entry to week 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
1433138|NCT00986986|Secondary|High-density Lipoprotein Cholesterol (HDL) Change From Baseline to Study Week 12|"HDL, often referred to Good cholesterol levels, will be obtained in both arms. HDL is a marker of coronary heart disease."|Two time points (baseline and study week 12)||||mg/dl||Inter-Quartile Range|Median
1432640|NCT00991302|Secondary|Self-management Skills, as Measured by Self-reported General Self-efficacy Scale (GSES) Score|"The GSES is a 10-item scale designed to assess optimistic self-beliefs used to cope with a variety of demands in life. The scale was designed to assess self efficacy, i.e., the belief that one’s actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate participant’s stronger belief in self-efficacy.~The GSES score was sum of all responses. The range was from 0 to 40 scores: any unfinished question got a score of zero."|At weeks 0 (entry), 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||scores on a scale||Inter-Quartile Range|Median
1432641|NCT00991302|Secondary|Virologic Suppression|Virologic suppression was defined as HIV-1 RNA <=200 copies/mL at week 24, 48, and 72. The results obtained within +/- 12 weeks of 24, 48, and 72 weeks were included. If there were multiple HIV-1 RNA measurement within the specified window, the HIV-1 RNA result closest to the center of the window was selected.|At week 24, 48, 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||percentage of participants||95% Confidence Interval|Number
1432642|NCT00991302|Secondary|Kaplan-Meier Estimate of the Cumulative Probability of Time to Change of Initial Antiretroviral (ARV) Treatment Regimen for Any Reason by Week 48|"The Kaplan-Meier estimate of the cumulative probability of initial antiretroviral (ARV) treatment regimen for any reason by week 48.~Time to ARV treatment regimen change was defined as first time to change in the drug class of participant's ART regimen for any reason from study entry. Participants completing the study without a change in the drug class of their ART regimen were censored at their last visit."|From study entry to week 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
1432643|NCT00991302|Secondary|Mean Self-reported Adherence Score Over a One-month Recall|The mean of participant's average self-reported adherence score over a one-month recall across visit week 4, 12, 24, 36, 48, 60, and 72; missing values were ignored.|Weeks 4, 12, 24, 36, 48, 60, and 72|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||percentage of adherence score||Inter-Quartile Range|Median
1432644|NCT00991302|Primary|Mean Self-reported Adherence Score (%) Over a One-month Recall|"The adherence self-report questionnaire captured adherence at an Antiretroviral Therapy (ART) regimen over a one-month recall (0-100): 0 means none of anti-HIV medications were taken, 100 means every single dose of anti-HIV medications were taken. The primary endpoint evaluated for each participant was the average self-reported adherence over a one-month recall across each of their study visit week 4, 12, 24, 36, and 48: missing values were ignored.~Note: This was a change to the primary endpoint as described in the study protocol. This was due to an update to ACTG Case Report Form (CRF) that captured self-report adherence. Since the data captured on this form captured adherence over a longer timeframe and allowed for more variability in response, it was anticipated this endpoint would provide greater power to assess treatment differences."|At weeks 4, 12, 24, 36, and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||percentage of adherence score||Inter-Quartile Range|Median
1432645|NCT00991289|Secondary|Number of Participants With HCV Genotype 1|Confirmatory HCV genotyping was performed on stored plasma from entry using VERSANT HCV Genotype assay v2.0 (LiPA, RUO, Siemens Healthcare Diagnostics Inc., Tarrytown, NY).|Week 0|All participants who enrolled, except one participant who was found to have been ineligible after entry.|||participants|||Number
1432646|NCT00991289|Secondary|Change in log10 HCV Viral Load After 4 Weeks of Nitazoxanide (NTZ) Monotherapy.|Change in log10 HCV viral load was calculated as log10-transformed HCV viral load at Week 4 minus log10-transformed HCV viral load at study entry. HCV viral load testing was done using Cobas AmpliPrep/Taqman HCV Test.|Weeks 0, 4|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HCV viral load measurements available at entry and at Week 4 were analyzed.|||log10 IU/mL||Inter-Quartile Range|Median
1432647|NCT00991289|Secondary|Percent Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) From Study Entry|HOMA-IR was calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Percent Change in HOMA-IR was calculated as HOMA-IR at later time point (16, 28, 52, 76) minus HOMA-IR at study entry, divided by HOMA-IR at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had fasting insulin and fasting glucose measurements available at entry and the respective post-entry time point: 56 at Week 16, 39 at Week 28, 27 at Week 52 and 22 at Week 76.|||percentage of HOMA-IR at study entry||Inter-Quartile Range|Median
1432648|NCT00991289|Secondary|Percent Change in Fasting Glucose Level From Study Entry|Percent Change in fasting glucose (FGLUC) was calculated as FGLUC at later time point (16, 28, 52, 76) minus FGLUC at study entry, divided by FGLUC at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting glucose testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had FGLUC measurement available at entry and the respective post-entry time point: 58 at Week 16, 41 at Week 28, 29 at Week 52 and 24 at Week 76.|||percentage of FGLUC at study entry||Inter-Quartile Range|Median
1432649|NCT00991289|Secondary|Percent Change in Fasting Insulin Level From Study Entry|Percent Change in fasting insulin (FINS) was calculated as FINS at later time point (16, 28, 52, 76) minus FINS at study entry, divided by FINS at study entry x 100%. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin testing.|Weeks 0, 16, 28, 52, and 76|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had FINS measurement available at entry and the respective post-entry time point: 58 at Week 16, 40 at Week 28, 28 at Week 52 and 23 at Week 76.|||percentage of FINS at study entry||Inter-Quartile Range|Median
1432650|NCT00991289|Secondary|Change in Hemoglobin Level From Study Entry|Change in hemoglobin (HGB) was calculated as HGB at later time point (Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76) minus HGB at study entry.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76.|All participants who enrolled, except one participant who was found to have been ineligible after entry, and had HGB measurement available at entry and at the respective post-entry time point: 65, 65, 63, 60, 55, 51, 45, 38, 39, 34, 31, 32, 31 and 29 participants at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 76, respectively.|||g/dL||Inter-Quartile Range|Median
1432651|NCT00991289|Secondary|Number of Participants With Adverse Events of Grade 2 or Higher|Number of participants who experienced an adverse event of Grade 2 or higher at any time after study entry. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004.|From study entry to up to week 76|All participants who enrolled, except one participant who was found to have been ineligible after entry.|||participants|||Number
1432652|NCT00991289|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|Rapid virologic response (RVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 8 where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 8|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 8 HCV viral load result were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
1432653|NCT00991289|Secondary|Percentage of Participants With Sustained Virologic Response (SVR)|Sustained virologic response (SVR) was defined as undetectable HCV viral load (<43 IU/ml) at 24 weeks after treatment discontinuation, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test). Participants who failed to achieve EVR or had detectable HCV RNA at Week 28 and per protocol discontinued study, and participants without HCV RNA from 24 weeks after treatment discontinuation, were considered non-responders.|24 weeks after treatment discontinuation|All participants who enrolled, except one who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without HCV RNA from 24 weeks after treatment discontinuation, non-EVRs and those with detectable HCV RNA at Week 28, were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
1432654|NCT00991289|Primary|Percentage of Participants With Early Virologic Response (EVR)|Early virologic response (EVR) was defined as undetectable HCV viral load (<43 IU/ml) at Week 16 or at least a 2-log10 decrease in HCV viral load from study entry at Week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Weeks 0, 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
1432655|NCT00991289|Primary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Complete early virologic response (cEVR) was defined as undetectable HCV viral load (<43 IU/ml) at week 16, where 43 is the lower limit of quantification of the assay (Cobas AmpliPrep/Taqman HCV Test).|Week 16|All participants who enrolled, except one participant who was found to have been ineligible after entry. The analysis was intention to treat wherein participants who dropped out early without Week 16 HCV viral load result were considered non-responders.|||percentage of participants||90% Confidence Interval|Number
1432656|NCT00991276|Secondary|Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)|RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
1432657|NCT00991276|Secondary|Medical Outcomes Study - Sleep Scale (MOS-SS)|MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity[range 0-24 hours], optimal sleep[range 0-1: 0= <7 or >8 hours;1=7/8 hours]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed for particular subscale for each arm group respectively."|||units on a scale||95% Confidence Interval|Least Squares Mean
1432658|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale|SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep [in minutes]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1434157|NCT00979459|Primary|Maximum Plasma Concentration (Cmax) for MK-1006|Maximum plasma concentration for 2 formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose||||nM||95% Confidence Interval|Geometric Mean
1432659|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
1432660|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of each intervention period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432661|NCT00991276|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale|SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||awakenings||95% Confidence Interval|Least Squares Mean
1432662|NCT00991276|Secondary|Hourly and Quarterly Assessment of Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of time asleep||95% Confidence Interval|Least Squares Mean
1432663|NCT00991276|Secondary|Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)|PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least one dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
1432664|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Arousals (NASO)|NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||arousals||95% Confidence Interval|Least Squares Mean
1432665|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||awakenings||95% Confidence Interval|Least Squares Mean
1432693|NCT00991081|Secondary|Intention to Quit|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Intention, confidence, and expectation of quitting smoking Range: 3-21 Direction: Higher values represent increased intention to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432666|NCT00991276|Secondary|Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||awakenings||95% Confidence Interval|Least Squares Mean
1432667|NCT00991276|Secondary|Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)|WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|"ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively."|||minutes||95% Confidence Interval|Least Squares Mean
1432668|NCT00991276|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||Percentage of time asleep||95% Confidence Interval|Least Squares Mean
1432669|NCT00991276|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432670|NCT00991276|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432671|NCT00991276|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432672|NCT00991276|Secondary|Latency to Persistent Sleep (LPS)|LPS, as determined by PSG, was number of epochs from the beginning of the recording (“lights-out”) to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432673|NCT00991276|Secondary|Latency to Stage R Sleep (LREM)|LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432694|NCT00991081|Secondary|Fatalism|Category: Psychological Outcome Instrument: Powe Fatalism Inventory, 10-item, revised Measures: belief in inevitability of smoking status Range: 0-10 Direction: Higher values represent increased fatalism beliefs|12 weeks after Target Quit Date|Follow-up psychological outcome analyses include only those participants not lost to follow-up (n = 30)|||units on a scale||Standard Deviation|Mean
1441663|NCT00923260|Primary|Components of Metabolic Syndrome (Triglycerides)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
1432674|NCT00991276|Secondary|Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale|CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected.|Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants|||Number
1432675|NCT00991276|Secondary|International Restless Legs Syndrome Study Group Rating Scale (IRLS)|IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
1432676|NCT00991276|Secondary|Arousal Index (NASOI)|Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||arousals/hour||95% Confidence Interval|Least Squares Mean
1432677|NCT00991276|Secondary|Number of Arousals (NASO)|NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||arousals||95% Confidence Interval|Least Squares Mean
1432678|NCT00991276|Secondary|Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)|NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||awakenings||95% Confidence Interval|Least Squares Mean
1432679|NCT00991276|Secondary|Periodic Limb Movement in Sleep Index (PLMSI)|PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
1432680|NCT00991276|Secondary|Periodic Limb Movement Index (PLMI)|PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
1432681|NCT00991276|Secondary|Restless Legs Syndrome-Next Day Impact (RLS-NDI)|RLS-NDI:participant-rated instrument to assess daytime performance and participant’s previous night’s sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
1432695|NCT00991081|Secondary|Depression|Category: Psychological Outcome Instrument: Center for Epidemiologic Studies Depression Scale (CES-D) Measures: Interest in participating in recommended treatment plan Range: 0-60 Direction: Higher values represent increased symptoms of depression|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 30)|||units on a scale||Standard Deviation|Mean
1432682|NCT00991276|Secondary|Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)|NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM [Stage N2] 30-second (30-sec) epoch, Stage 3 Non-REM [Stage N3] 30-sec epoch, or stage rapid eye movement [stage R] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||awakenings||95% Confidence Interval|Least Squares Mean
1432683|NCT00991276|Secondary|Minutes of Stage N1, N2, N3 and R Sleep|Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432684|NCT00991276|Secondary|Subjective Total Sleep Time (sTST)|sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model.|Week 3 and Week 5 of Each Intervention Period or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432685|NCT00991276|Secondary|Periodic Limb Movement Arousal Index (PLMAI)|PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET|ITT population included set of randomized participants who had at least 1 dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||movement/hour||95% Confidence Interval|Least Squares Mean
1432686|NCT00991276|Primary|Wake After Sleep Onset (WASO)|WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep [WTDS] epochs + Wake Time After Sleep [WTAS] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.|Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)|Intent to Treat (ITT) population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||minutes||95% Confidence Interval|Least Squares Mean
1432687|NCT00991185|Primary|CSF:Serum Ratio of Vancomycin|CSF:serum ration of vancomycin|within 1 week of drug administration||||ratio||Full Range|Median
1432688|NCT00991081|Secondary|Threat Minimization|Category: Psychological Outcome Instrument: 2-item inventory, Likert scale from 1 to 7 Measures: Perceived presence of factors that would reduce personal smoking risks Range: 2-14 Direction: Higher values represent increased risk minimization|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432689|NCT00991081|Secondary|Self-Efficacy|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Perceived ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased self-efficacy|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432690|NCT00991081|Secondary|Risk Perception|Category: Psychological Outcome Instrument: 4-item inventory, Likert scale from 1 to 5 Measures: Perceived personal health risks from smoking Range: 4-20 Direction: Higher values represent increased perception of risk|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432691|NCT00991081|Secondary|Perceived Control|Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Control over ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased sense of control|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432692|NCT00991081|Secondary|Motivation|Category: Psychological Outcome Instrument: Single item, Likert scale from 1 to 7 Measures: Desire to quit smoking Range: 1-7 Direction: Higher values represent increased motivation to quit|Within 1 week of first clinical call|First psychological outcome analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432768|NCT00989950|Primary|Sleep Latency|Measure by daily subject sleep diary|9 weeks|All 26 subjects wore the patches for 9, 10, 11 and 12 hour wears. Results are based upon impact of patch wear time on parameter|||minutes||95% Confidence Interval|Mean
1432696|NCT00991081|Secondary|Treatment Interest Scale|Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432697|NCT00991081|Secondary|Satisfaction Scale|Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432698|NCT00991081|Secondary|Communication Scale|Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432699|NCT00991081|Secondary|Trust Scale|Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust|Within 1 week of first clinical call|First treatment satisfaction analyses include participants who received the first clinical call (n = 33)|||units on a scale||Standard Deviation|Mean
1432700|NCT00991081|Secondary|Morisky Adherence Scale|Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance|12 weeks after Target Quit Date|Follow-up treatment satisfaction analyses includes only those participants not lost to follow-up (n = 30)|||units on a scale||Standard Deviation|Mean
1432701|NCT00991081|Primary|Continuous Abstinence at 12 Weeks Post Target Quit Date|"Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as abstinent. All others were recorded as not abstinent."|12 weeks after Target Quit Date|All randomized participants were included in the data analysis.|||participants|||Number
1432702|NCT00990964|Primary|Subjects Without a Left-heart Lead and Delivery Catheter Related Complication|A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC).|Implant to 3 months||||participants|||Number
1432703|NCT00990964|Primary|Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter|Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.|Implant||||participants|||Number
1432704|NCT00990821|Primary|Area Under the Plasma-Time Curve (AUC[0 to Infinity]) for Aprepitant and MK-0517 for Study Part V|AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The AUC(0-inf) bioequivalence was evaluated for single doses of 100 and 115 mg MK-0517 PS80, IV and that of an oral 125-mg capsule of aprepitant. Period I to IV populations are not included in the outcome analysis because those were formulation and dose-finding/dose confirmation arms.|Up to 72 Hours Post Dose|All participants in Part V who had at least one period of AUC data were included in the evaluation of pharmacokinetics. Participants without sufficient concentration data for an AUC calculation included: 6 participants in the Aprepitant (125 mg) , 8 participants in the MK-0517 (100 mg) group, and 5 participants in the MK-0517 (115 mg) group.|||ng*hr/mL||Standard Deviation|Least Squares Mean
1432705|NCT00990782|Secondary|Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA||14 Days||||Participants|||Count of Participants
1432706|NCT00990782|Primary|Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy||14 days||||Participants|||Count of Participants
1432707|NCT00990769|Secondary|Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)|Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.|Within 30 minutes of arrival in recovery room|All patients were analyzed.|||units on a scale||Standard Deviation|Mean
1432708|NCT00990769|Secondary|Time to Emergence From Anesthesia|The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.|After the completion of surgery|All patients were analyzed|||minutes||Standard Deviation|Mean
1432709|NCT00990769|Primary|Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)|The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 – 20, with higher scores indicating greater severity of emergence agitation.|Within 30 minutes of arrival in recovery room|All patients in each group were analyzed.|||units on a scale||Standard Deviation|Mean
1432710|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH||Over the 12-week treatment period||||Occurrences per participant||Standard Deviation|Mean
1432711|NCT00990704|Secondary|Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline||Over the 12-week treatment period||||Occurrences per participant||Standard Deviation|Mean
1432712|NCT00990704|Secondary|Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia||||Percentage of participants|||Number
1432769|NCT00989911|Primary|Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months|Magnetic resonance imaging-derived aortic flow|3-6 months||||L/min||Standard Deviation|Mean
1432713|NCT00990704|Secondary|Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment|Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.|Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia||||Percentage of participants|||Number
1432714|NCT00990704|Secondary|Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks||Baseline and the last 3 weeks (Weeks 11, 12, and 13)||||pg/mL||Standard Deviation|Mean
1432715|NCT00990704|Secondary|Mean iPTH at Each Visit||Screening (up to 2 weeks before Baseline) to Week 13||||pg/mL||Standard Deviation|Mean
1432716|NCT00990704|Secondary|The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks||During the last 3 weeks (Weeks 11, 12, and 13)||||Percentage of participants|||Number
1432717|NCT00990704|Primary|The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.||Baseline and the last 3 weeks (Weeks 11, 12, and 13)|All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment.|||Percentage of participants|||Number
1432718|NCT00990652|Secondary|Overall Survival Rate at 6 Months|The rate of overall survival at 6 months (regardless of disease progression) was calculated.|After 6 months on study|The 6-month overall survival rate was based on a median of 168 days of follow-up.|||percentage of participants|||Number
1432719|NCT00990652|Secondary|Overall Survival (in Days)||Days 1, 4, 8 pre-surgery, once per cycle (every 4 weeks) while on treatment post-surgery, and then every 3 months up to 2 years during follow-up||||days||95% Confidence Interval|Median
1432720|NCT00990652|Other Pre-specified|Pharmacokinetics of Bortezomib in Tumor Tissue Taken at the Time of Surgery.||Tissue sample taken at the time of surgery for all patients.|||||||
1432721|NCT00990652|Other Pre-specified|Change in MGMT Methylation Status as Well as Other Methylation Patterns in Plasma|To determine MGMT methylation status as well as other methylation patterns in plasma|Blood samples drawn on days 1, 4, and 8 pre-surgery, and then prior to cycle 1 and every 2 cycles thereafter|||||||
1432722|NCT00990652|Secondary|Number of Grade 1, 2, 3, 4, and 5 Adverse Events Observed During Study Treatment (Defined by CTCAE v 3.0)|"Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Days 1, 4, 8 pre-surgery, and then at the start of every cycle (approximately every 4 weeks) post-surgery while on treatment||||adverse events|||Number
1432723|NCT00990652|Secondary|Number of Participants Achieving a Response to Treatment (Either Complete or Partial Response) as Defined by MacDonald Criteria|"This measure was assessed only in patients who had residual tumor post-operatively. Per MacDonald Criteria:~Complete Response requires complete disappearance of all measurable & evaluable disease, no new lesions, no evidence of non-evaluable disease, and only minimal or no use of steroids.~Partial Response is defined as >= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions, no progression of evaluable disease, and no new lesions. Responders must be on the same or decreasing doses of steroid.~Response was assessed by imaging (MRI or CT with contrast)."|Day of treatment post-surgery and then approximately every 8 weeks thereafter until off treatment|Only those participants who had residual tumor remaining after surgical resection were evaluated for this outcome.|||participants|||Number
1432724|NCT00990652|Primary|Number of Patients Surviving Without Disease Progression After 6 Months|"Patients will be monitored from date of first treatment to the date of first observation of progressive disease, non-reversible neurologic progression or increasing steroid requirements, death due to any cause, or early discontinuation of treatment. Progression-free survival will be defined as the absence of any of the above after 6 months.~Progression (defined by MacDonald Criteria) is a 25% increase in the sum of products of all measurable lesions over smallest sum observed compared to baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to the cancer)."|From date of first treatment until disease progression, death, or early discontinuation of treatment (up to 24 months)||||participants|||Number
1432725|NCT00990652|Other Pre-specified|Correlation of Expression of NFKBIA Gene With Response to Therapy and Survival.|The effects of bortezomib on the endogenous modulators of NF-Kappa B pathways, especially the NFKBIA gene (nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor, alpha) were assessed using novel assay technology; expression of NFKBIA was then correlated with response to therapy and patient survival.|Tissue samples for analysis were obtained on the day of surgery for all patients|||||||
1432726|NCT00990561|Secondary|Maintenance of Psoriasis Improvement With Lac-Hydrin Lotion After Discontinuation of Steroid Therapy||6 weeks|||||||
1432727|NCT00990561|Primary|Change in Modified Psoriasis Area Severity Index (PASI) Score|PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).|2 weeks|This was a pilot study and the number was based on the available budget to perform the study.|||units on a scale||Full Range|Mean
1432728|NCT00990509|Primary|Mean Intracerebral Hemorrhage (ICH) Volume|11 of 14 participants received a Day 5 MRI. Mean ICH volume based on 11 participants is presented.|Day 5 MRI||||cc||Standard Deviation|Mean
1432729|NCT00990509|Primary|Assessment of Safety of Albumin Administration in Primary ICH|Serious adverse events. Specific safety outcomes assessed: frank pulmonary edema as visualized on chest X-Ray, congestive heart failure, neurological deterioration (4-point worsening on NIHSS), death|Through Day 90 following enrollment||||events|||Number
1432730|NCT00990509|Primary|Mean Hyperintense Acute injuRy Marker (HARM)|Hyperintense Acute injuRy Marker (HARM) characterizes the frequency and severity of blood brain barrier disruption. Mean HARM is assessed on the post-contrast study using a previously developed 5 point scale (0 to 5).). A score of 0 indicates no HARM, whereas a score of 5 indicates diffuse and generalized HARM. 11 of 14 participants received a Day 5 MRI. HARM reads could only be performed on 4 of the 7 placebo subjects due to insufficient sequences or presence of subarachnoid blood. Mean HARM score is presented.|Day 5 MRI||||points|||Number
1432731|NCT00990340|Secondary|Subject-reported Overall Satisfaction Following the End of Each Period of the Study.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
1432732|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.|The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.|28 Days; end of Period 1(14 days) and end of Period 2 (14 days)|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
1432733|NCT00990340|Secondary|Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like arms were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|2 weeks|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
1432734|NCT00990340|Secondary|Subject-reported Injection Pain Immediately Following Administration.|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Least Squares Mean
1432735|NCT00990340|Primary|Subject-reported Injection Anxiety Immediately Before Administration|The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.|28 days; Period 1: 14 days, Period 2: 14 days|Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.|||Scores on a scale||Standard Deviation|Mean
1432736|NCT00990288|Secondary|Visual Analog Pain Scale at 6 Weeks|"A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.~The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity."|6 weeks postoperatively|Patients whose pain level at 6-week followup appointment was taken were included in analysis.|||points on visual analog pain scale||Standard Deviation|Mean
1432737|NCT00990288|Primary|Homologous Amount of Transfusion||three days postoperatively||||units of blood||Standard Deviation|Mean
1432738|NCT00990288|Primary|Autologous Amount of Transfusion||three days postoperatively||||units of blood||Standard Deviation|Mean
1432739|NCT00990288|Primary|Drain Output||24 hours postoperatively|Drain output at 24 hours was recorded for all patients.|||mL||Standard Deviation|Mean
1432740|NCT00990288|Primary|Change in Hematocrit on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/L||Standard Deviation|Mean
1432741|NCT00990288|Primary|Change in Hemoglobin on Day 2 Compared to Preoperatively||preoperatively and two days after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.|||g/dL||Standard Deviation|Mean
1432742|NCT00990288|Secondary|Range of Motion at Six Weeks||6 weeks postoperatively|Patients whose range of motion at 6-week followup appointment was taken were included in analysis.|||degrees||Standard Deviation|Mean
1432743|NCT00990288|Primary|Change in Hematocrit on Day 1 Compared to Preoperatively||preoperatively and 1 day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/L||Standard Deviation|Mean
1432744|NCT00990288|Secondary|Visual Analog Pain Scale on Day 3|"A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.~The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity."|3 days postoperatively|All patients whose pain score was collected were included in analysis.|||points on visual analog pain scale||Standard Deviation|Mean
1432745|NCT00990288|Secondary|Range of Motion on Day 3||3days postoperatively|Patients whose range of motion at 3 day followup appointment was taken were included in analysis.|||degrees||Standard Deviation|Mean
1432746|NCT00990288|Primary|Change in Hemoglobin On Day 1 Compared to Preoperatively||preoperatively and one day after surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/dL||Standard Deviation|Mean
1432747|NCT00990288|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis.|||g/L||Standard Deviation|Mean
1432748|NCT00990288|Primary|Change in Hemoglobin on Day 0 Compared to Preoperatively||preoperatively and on the day of surgery|All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons|||g/dL||Standard Deviation|Mean
1432749|NCT00990249|Primary|Treatment-Related Mortality (TRM) Defined as Non Relapse Mortality (NRM)|NRM was defined as death from any cause other than disease progression or relapse and reported as percentage of participant deaths. Treatment related deaths after transplant are defined either by deaths which could not be attributed to disease relapse or progression or by deaths without previous relapse or progression. For TRM at day 100, Bayesian method of Thall, Simon, and Estey used to perform interim monitoring.|100 Days|Only 107 participants were evaluated.|||percentage of participants|||Number
1432750|NCT00990184|Secondary|Glucose Disappearance Rate|Rate of fall of glucose in the blood|Baseline and 8 weeks||||percentage of glucose/min||Standard Error|Mean
1432751|NCT00990184|Secondary|Insulin Sensitivity|"Tissue response to circulating insulin in the blood. Insulin sensitivity is measured using a mathematical model that quantifies the fractional rate of change in glucose concentrations per unit of insulin. Low values are insulin resistant and high values are insulin sensitive. *Please note: the -1 in the Unit of Measure should be a superscripted value."|Baseline and 8 weeks||||min-1 per pmol/L||Standard Error|Mean
1432752|NCT00990184|Primary|Acute Insulin Response (AIRg) to Intravenous Glucose|Increase in insulin following glucose injection. AIRg is measured as the magnitude of the insulin response to an intravenous glucose injection calculated over the 10 minutes following glucose administration.|Baseline and 8 weeks|Subjects who completed the study|||pmol/1*min||Inter-Quartile Range|Median
1432753|NCT00990106|Primary|Clinical Global Impression of Change (CGIC)|The Clinical Global Impression of Change is a 7-point scale that rates global change compared to baseline (1=markedly improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=moderately worse, 7=markedly worse). The CGIC is used to determine the impact of treat effects on meaningful and distinct change in overall sense of well-being and functioning. This outcome measures the proportion of responders who were rated markedly or moderately improved at Week 15 compared to Baseline.|Change from Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.|||Percentage of responders||95% Confidence Interval|Number
1432754|NCT00990106|Primary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index is a self-report questionnaire assessing sleep quality and disturbances over a 1-month time interval. A global score is obtained by summing the seven component subscales (total score range: 0-21). A score of 5 or less indicates good sleep quality. A score of more than 5 indicates poor sleep quality. Change is measured from Baseline to Week 15.|Baseline to Week 15||||Scores on a Scale||Standard Error|Mean
1432755|NCT00990106|Primary|Change in Clinician Administered PTSD Scale for DSM-IV (CAPS) Recurrent Distressing Dreams Item|"Item B-2 recurrent distressing dreams of the event is a single item from the Clinician Administered PTSD Scale. The rating consists of two parts: Frequency and Intensity. Symptom frequency rated 0 to 4. Symptom intensity rated 0 to 4. Frequency plus Intensity ratings equal the total score. A higher score is worse; a lower score is better. This outcome measure evaluates the change in score from Baseline to Week 15."|Baseline to Week 15|Of the 67 subjects randomized, 46 completed the full 15 weeks (23 per group). The outcome data reports only those 46 participants who completed the full 15 weeks.|||Scores on a Scale||Standard Error|Mean
1432756|NCT00990093|Primary|Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort.|"Participants were to test the catheter by self-catheterising a minimum of 4 catheters each day for 14 days.~At the end of each study period participants were asked to indicate how they would rate the discomfort experienced during the catheterisation procedures. Discomfort was measured by the participants own rating of discomfort on a VAS scale from 0 (no discomfort) to 10 (worst imaginable discomfort)"|14 days|Six participants discontinued the study in the first test period, i.e. before visit 2 at which the first catheter evaluation was to be given. The primary outcome was the catheter evaluation on discomfort, and these six participants did not contribute to the ITT analysis of the primary outcome.|||units on a scale||Standard Deviation|Mean
1432757|NCT00989989|Secondary|Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||units on a scale||Standard Deviation|Mean
1432770|NCT00989833|Secondary|Number of Participants With an Adverse Event During the Study||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Participants|||Number
1432758|NCT00989989|Secondary|Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Letters||Standard Deviation|Mean
1432759|NCT00989989|Secondary|Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 15 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
1432760|NCT00989989|Secondary|Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 15 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
1432761|NCT00989989|Secondary|Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A loss of 10 or more BCVA letters from baseline indicates worsening.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
1432762|NCT00989989|Secondary|Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A gain of 10 or more BCVA letters from baseline indicates improvement. A BCVA of 84 letters or more at Month 12 indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Percentage of participants|||Number
1432763|NCT00989989|Secondary|Percent of Participants With Visual Acuity Above 73 Letters at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 indicates a positive outcome.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment)and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||percentage of participants|||Number
1432764|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline|Presence or absence of sub-retinal fluid in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of sub-retinal fluid indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had sub-retinal fluid in any of the 6 sections of the study eye at baseline. Not applicable means there was no sub-retinal fluid at baseline.|||percentage of participants|||Number
1432765|NCT00989989|Secondary|Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline|Presence or absence of intra-retinal cysts in any of the 6 sections of the study eye was measured using Optical Coherence Tomography (OCT). A complete resolution or decrease from baseline of intra-retinal cysts indicates improvement.|Up to 12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had intra-retinal cysts in any of the 6 sections of the study eye at baseline - not applicable means there was no intra-retinal cyst at baseline.|||percentage of participants|||Number
1432766|NCT00989989|Secondary|Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12|Central Retinal Subfield Thickness (CRST) was measured using Optical Coherence Tomography (OCT) in micrometers. A negative change from baseline of CRST indicates improvement.|12 months|The Full Analysis Set consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had Central Retinal Subfield Thickness value with signal strength ≥ 5 for Carl Zeiss Optical Coherence Tomography 3 system.|||micrometers||Standard Deviation|Mean
1432767|NCT00989989|Primary|Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement.|12 months|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one application of study treatment (ranibizumab or sham injection and/or laser or sham treatment) and had at least one post-baseline assessment for Best-Corrected Visual Acuity.|||Letters||Standard Deviation|Mean
1446882|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
1432771|NCT00989833|Secondary|Diary Recording of Asthma Symptoms|Asthma symptoms during days with exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Percent of exercise days||Standard Deviation|Mean
1432772|NCT00989833|Secondary|Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)|Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.|Baseline e and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||units on a scale||Standard Deviation|Mean
1432773|NCT00989833|Secondary|Use of as Needed Medication|Mean number of as needed inhalations taken before exercise|6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||number of inhalations per day||Standard Deviation|Mean
1432774|NCT00989833|Secondary|Concentration of Exhaled Nitric Oxide||6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||ppb||Standard Deviation|Mean
1432775|NCT00989833|Secondary|Bronchial Responsiveness to Mannitol|Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)|Baseline and 6 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||mg||Standard Deviation|Mean
1432776|NCT00989833|Secondary|Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks|FEV1|Baseline and 3 weeks|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Percent change||Standard Deviation|Mean
1432777|NCT00989833|Primary|Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks|FEV1|Baseline and Visit 6|The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.|||Percent change||Standard Deviation|Mean
1432778|NCT00989781|Other Pre-specified|Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls|3-D ultrasound was not assessed; instead 2-D ultrasound was performed|baseline||||Antral Follicle Count||Standard Error|Mean
1432779|NCT00989781|Secondary|Anti-Mullerian Hormone (AMH)||Baseline||||ng/ml||Standard Error|Mean
1432780|NCT00989781|Secondary|17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.|17 hydroxyprogesterone levels|Baseline and 24 after hCG||||Participants|||Count of Participants
1432781|NCT00989781|Secondary|Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls|17-hydroxyprogesterone response to ACTH infusion in women with PCOS and normal women. Response is reported as a single value generated by summing the data at end time frame.|Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH||||ng/ml||Standard Error|Mean
1432782|NCT00989781|Primary|17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls|Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection|Baseline and 24 hours after hCG||||ng/ml||Standard Error|Mean
1432783|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|112 days||||microVolts||Standard Deviation|Mean
1432784|NCT00989768|Secondary|ECMAP in m. Frontialis|The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days||||microvolts||Standard Deviation|Mean
1432785|NCT00989768|Primary|Horizontal Action Halo Diameter at 112 Days|The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|112 days||||centimeter||Standard Deviation|Mean
1432786|NCT00989768|Primary|Horizontal Action Halo Diameter at 28 Days|The colorful complex formed by Minor’s test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).|28 Days||||centimeter||Standard Deviation|Mean
1432787|NCT00989664|Secondary|Number of Participants With Hypothyroidism Prior to Therapy and After the Therapeutic Dose|Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the Iodine 131 on thyroid function. Hypothyroidism is a condition in which the thyroid gland does not make enough thyroid hormone.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who were evaluable for thyroid function assessment were analyzed.|||participants|||Number
1432788|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event. Grade 3/4 hematological toxicities: hemoglobin <8.0 g/dL; platelets <50,000 cells per millimeters (mm)^3; ANC <1000 cells per mm^3; WBC <2000 cells per mm^3.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population|||participants|||Number
1432789|NCT00989664|Secondary|Time to HAMA Positivity From the First Dosimetric Dose|HAMA are human immunoglobulins with specificity for mouse immunoglobulins. HAMA assays were conducted in the laboratory to measure conversion to HAMA positivity following treatment. Time to HAMA positivity was calculated as the difference between the day on which HAMA positivity occurred and the first dosimetric dose administration day.|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were analyzed.|||days||Full Range|Median
1432790|NCT00989664|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Before Receiving the Dosimetric Dose) But Positive or Negative After Receiving the Dosimetric Dose|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit."|HAMA was measured at baseline; Day5; Weeks 7, 17, 25; and then every 12 months while in study BEX104526. Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.|||participants|||Number
1432791|NCT00989664|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.|||participants|||Number
1432792|NCT00989664|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced any infection were analyzed.|||participants|||Number
1432793|NCT00989664|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced SAEs were analyzed.|||participants|||Number
1432794|NCT00989664|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious AEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.|||participants|||Number
1432795|NCT00989664|Secondary|Number of Participants With the Indicated Fatal Serious Adverse Events (SAE) Unrelated to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgment.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced fatal SAEs were analyzed.|||participants|||Number
1432796|NCT00989664|Secondary|Number of Participants With the Indicated Time to Death From the Last Dose of Study Drug|Time to death from the last dose of study drug is the time period difference between when study drug treatment stopped and when death occurred.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.|||participants|||Number
1432797|NCT00989664|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who died during the study were analyzed.|||participants|||Number
1432820|NCT00989287|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 364|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1432798|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Related to Study Drug and Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or 4 AEs related to study drug were analyzed.|||participants|||Number
1432799|NCT00989664|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by at Least 5% of Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced Grade 3 or Grade 4 AEs were analyzed.|||participants|||Number
1432800|NCT00989664|Secondary|Number of Participants With the Indicated Adverse Events (AE) Related to Study Drug Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was related to study drug.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. All participants who experienced any AE related to study drug were analyzed.|||participants|||Number
1432801|NCT00989664|Secondary|Number of Participants With Responses of CR, CCR, CR+CCR, and PR Following TST and I 131 TST and Following the LQCR, as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
1432802|NCT00989664|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
1432803|NCT00989664|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced treatment failure were analyzed.|||months||95% Confidence Interval|Median
1432804|NCT00989664|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants who experienced disease progression or died were analyzed.|||months||95% Confidence Interval|Median
1432805|NCT00989664|Secondary|Number of Participants With Any Confirmed Response (CR, CCR, or PR), Confirmed CR, Confirmed CCR, Confirmed CR+CCR, and Confirmed PR, as Assessed by Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with CR, CCR , or PR. A confirmed response (CR/CCR/PR) had to be confirmed by a consecutive response (>=28 days [ 4 weeks] later) that was the same or better. Individual confirmed response data only counts that response confirmed by the same response; thus, not all possible combinations are represented.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1432806|NCT00989664|Secondary|Number of Participants With Any Uncofirmed Response (CR, Clinical Complete Response [CCR], or PR), CR, CCR, CR+CCR, and PR), as Assessed by the Investigator|Participants with response include those with CR, CCR, or PR. Criteria for CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Criteria for CCR: complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Criteria for PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
1432821|NCT00989287|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period. No subjects from the GSK2340269A Group reported any temperature after Dose 2.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1432807|NCT00989664|Primary|Duration of Response for Par. Receiving TST and I 131 TST With a Response >=30 Days Versus the Number of Par. With a Response >=30 Days After Their LQCR, as Assessed by the MIRROR Panel|Duration of response is defined as the time from the first documented response (for par. with complete response, complete response unconfirmed, or partial response) until disease progression (DP). DP is defined as a >=25% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population. Only those participants with complete response, complete response unconfirmed, or partial response were analyzed.|||months||95% Confidence Interval|Median
1432808|NCT00989664|Primary|Number of Participants (Par.) Receiving TST and I 131 TST With a Response >=30 Days Versus Par. With a Response >=30 Days After Their Last Qualifying Chemotherapy Regimen (LQCR), Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Par. with response are those with complete response (CR; complete resolution of all disease-related radiological abnormalities and the disappearance of all signs/symptoms related to disease), complete response unconfirmed (CRu; meets characteristics of CR, except the nodal size hasn’t regressed sufficiently, or there is indeterminate bone marrow), or partial response (PR; >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions). Participants' LQCR was used as a comparator for subsequent treatment with Iodine I 131TST.|Participants were evaluated for up to 99.1 months in Study 104504 or were followed in the long-term follow-up study for up to 141.5 months|ITT Exposed Population|||participants|||Number
1432809|NCT00989586|Secondary|Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA)|Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA).|up to 36 weeks|HAHA titres were assayed for patients in Phase I and Phase II|||patients|||Number
1432810|NCT00989586|Secondary|Access Pharmacokinetics Through Cmax|Evaluation of pharmacokinetics of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-dose|Cmax for patients dosed at 20 mg/kg|||ug/ml||Standard Deviation|Mean
1432811|NCT00989586|Secondary|Access Pharmacokinetics Through AUC0–∞ (Area Under Curve)|Evaluation of pharmacokinetics (Pk) of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.|0, 24, 48, 72, 96 and 120 hours post-does|AUC0–∞ for patients dosed at 20 mg/kg|||d*ug/ml||Standard Deviation|Mean
1432812|NCT00989586|Secondary|Quantitative T-, B-, and NK-cell Subsets Using Flow Cytometry|Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 at screening, after induction, and prior to the start of therapy on day 1 week 12, day 1 week 28, and then every 4 months for one year.|up to 1 year|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.||||||
1432813|NCT00989586|Secondary|Fcγ-receptor Polymorphism Response to Treatment|The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes.|up to 2 years|This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.||||||
1432814|NCT00989586|Secondary|Progression-free Survival (PFS)|Progression is defined using International Response Criteria (Cheson JCO 2007), as a >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions.|up to 2 years||||months||95% Confidence Interval|Median
1432815|NCT00989586|Primary|Overall Objective Response Rate|Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR.|Up to 2 years||||percent of patients|||Number
1432816|NCT00989586|Primary|Maximum Tolerated Dose (MTD)for Phase I Patients|Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated|up to 2 years||||mg/kg|||Number
1432817|NCT00989586|Primary|Dose Limiting Toxicity (DLT) for Phase I Patients|Dose-limiting toxicity was assessed during induction therapy for phase I.|up to 2 years||||patients|||Number
1432818|NCT00989287|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1432819|NCT00989287|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1432822|NCT00989287|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or their relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
1432823|NCT00989287|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period. No subjects in GSK2340269A Group reported redness or swelling.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1432824|NCT00989287|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
1432825|NCT00989287|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1432826|NCT00989287|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1432827|NCT00989287|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1432828|NCT00989287|Secondary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
1432829|NCT00989287|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects (antibody titer < 10 post-vaccination), antibody titer ≥ 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1432830|NCT00989287|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1432831|NCT00989287|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
1432832|NCT00989287|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1432833|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1432834|NCT00989287|Secondary|Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1432835|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.|At Days 182 and 364|The analysis was performed on the ATP cohort for persistence at Day 182 and 364, which included all evaluable subjects who had received at least one dose of study vaccine according to their assignment, for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1432836|NCT00989287|Secondary|Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1432837|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
1432838|NCT00989287|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1432839|NCT00989287|Secondary|Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
1432840|NCT00989287|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1432841|NCT00989287|Primary|Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
1432842|NCT00989287|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after each vaccine dose.|||Participants|||Count of Participants
1432853|NCT00989235|Secondary|Percentage of Participants Who Lost Remission Status|Loss of remission is defined as DAS 28 CRP >=2.6.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
1432843|NCT00989235|Secondary|Participants With Positive Antibody Responses to Abatacept (Electrochemiluminescence [ECL] Method) During Double-Blind Treatment|A positive antibody response to Abatacept (measured by the ECL assay) is further classified as a positive response for either Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig)' or 'Ig and/or Junction Region'|After 12 months of treatment|Number of participants analyzed= Number of participants with available immunogenicity measurements|||participants|||Number
1432844|NCT00989235|Secondary|Clinically Significant Changes in Vital Signs and Physical Findings|Clinical significance was determined by investigator. Parameters include blood pressure, heart rate, respiration rate, and temperature.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|This analysis was not done because clinically significant changes in vital signs and physical findings were reported as adverse events.|||participants|||Number
1432845|NCT00989235|Secondary|Percentage of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During Double-Blind Treatment|Not evaluated: high hemoglobin,high hematocrit,high erythrocytes,high neutrophils+bands(N+B),low monocytes,low basophils,low eosinophils,low alkaline phosphatase(ALP),low aspartate aminotransferase(AST),low alanine aminotransferase(ALT),low G-Glutamyl transferase(GGT),low total bilirubin,low blood urea nitrogen,low creatinine,high albumin,low uric acid,low urine protein,low urine glucose,low urine blood,low urine leukocyte esterase,low urine white blood cells,low red blood cells.Pre Rx=pretreatment,(*)Lymphocytes(c/uL):Low<.750x10^3,High>7.50x10^3.(*)Eosinophils:>.750x10^3 c/uL.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period; n=number of participants with specific measure|||percentage of participants|||Number
1432846|NCT00989235|Secondary|Percentage of Participants With Pre-specified Autoimmune Disorders (ADs) Reported During Double-Blind Treatment, by Intensity|A total of 127 autoimmune disorders were prespecified in the protocol. MCTD=Musculoskeletal and Connective Tissue Disorders|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
1432847|NCT00989235|Secondary|Percentage of Participants With Prespecified Peri-Infusional Adverse Events (PAIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Peri-infusional AE=a pre-specified infusional AE occuring during the first 24 hours after the start of study drug infusion.A total of 105 infusional events were prespecified in the protocol. GDASC=General Disorders and Administration Site Conditions, RTMD=Respiratory, Thoracic and Mediastinal Disorders.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
1432848|NCT00989235|Secondary|Percentage of Participants With Prespecified Acute Infusional Adverse Events (AIAEs) During Double-Blind Treatment, by Intensity|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Acute Infusional AE= a subset of the peri-infusional AEs with onset during the first hour after the start of the study drug infusion. A total of 105 infusional events were prespecified in the protocol.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
1432849|NCT00989235|Secondary|Percentage of Participants With Malignant Neoplasms Reported During Double-Blind Treatment|All neoplasms were assessed by medical review as to whether or not the event was malignant.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
1432850|NCT00989235|Secondary|Percentage of Participants With Infection and Infestation AEs Reported During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Infection and Infestation AEs = any AE within the System Organ Class Infection and Infestation.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
1432851|NCT00989235|Secondary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations During Double-Blind Treatment|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|From start of substudy up to 56 days post last dose in the double-blind period or start of the open-label rescue period, whichever occurred first until end of study (study duration was 115 weeks)|Number of participants analyzed = All treated participants during the double-blind period.|||percentage of participants|||Number
1432852|NCT00989235|Secondary|Steady-state Trough Serum Concentration (Cmin) of Abatacept During Double-Blind Treatment||Day 701 of the main study; sub-study Days 1, 85, 169, 253|Number of participants analyzed= number of participants randomized; n =randomized participants with measurement at given time point. For the Day 701 measure, one apparent outlier sample was deleted..|||ng/mL||Standard Deviation|Mean
1432854|NCT00989235|Secondary|Percentage of Participants Who Modified Therapy During Double-Blind Treatment|Modified therapy=additional DMARD therapy, 2 or more courses of high dose steroids or rescue medication. Additional DMARD therapy=re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD. A course of high dose steroids=a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals). Rescue medication=abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
1432855|NCT00989235|Secondary|Percentage of Participants Given Rescue Medication Therapy During Double-Blind Treatment|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg or 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
1432856|NCT00989235|Primary|Time to Disease Relapse Through Month 12 (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse)|An event of disease relapse was defined as additional Disease-modifying antirheumatic drug (DMARD) therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 C-reactive protein (CRP) score >=3.2 at 2 consecutive visits. Time to disease relapse was evaluated using life tables (Kaplan-Meier Cumulative Percentage of Events of Disease Relapse).|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|Number of participants analyzed=number of participants randomized. n=number of participants at risk at the end of a specified month.|||Percentage of Events|||Number
1432857|NCT00989235|Secondary|Percentage of Participants Who at Any Time During Double-Blind Treatment Were Given 2 or More Courses of High-Dose Steroids|A course of high dose steroids is defined as a course of intramuscular, intravenous, or high dose oral corticosteroids (use of > 10 mg/day equivalent of prednisone for a minimum of 3 consecutive days or for those subjects who had continued use for long durations of time, each course was determined by 28 day intervals).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants|||Number
1432858|NCT00989235|Secondary|Percentage of Participants Given Additional DMARD Therapy During Double-Blind Treatment|Additional DMARD therapy is defined as a re-introduction of methotrexate (MTX), an increase of at least 2.5 mg of MTX, or the addition of at least 1 DMARD.|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
1432859|NCT00989235|Secondary|Percentage of Participants With 2 Consecutive DAS 28 CRP Scores ≥ 3.2 (Loss of Low Disease Activity Status)|DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|After 12 months of treatment|Number of participants analyzed= number of participants randomized.|||percentage of participants||95% Confidence Interval|Number
1432860|NCT00989235|Secondary|Adjusted Mean Change From Baseline in DAS28 CRP During Double-Blind Treatment|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a VAS of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline, Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365|Number of participants analyzed=number of participants randomized; n=the number of participants with available DAS28 CRP scores at that time point.|||units on a scale||Standard Error|Mean
1432861|NCT00989235|Secondary|Mean Time-Matched Baseline DAS28 CRP Scores|Mean baseline DAS28 CRP values for the cohort of participants with serum samples available at that timepoint. DAS 28 is a continuous variable which is a composite of 4 variables: number of tender joints out of 28, number of swollen joints out of 28 joints, CRP in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm. The DAS28 provides a score on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis (>5.1=high disease activity; <3.2=low disease activity; <2.6=remission).|Baseline|Number of participants analyzed=number of participants randomized; n=All treated participants with available DAS28 CRP scores at that time point. Mean time-matched baseline values reflect changing n-values over time.|||units on a scale||Standard Deviation|Mean
1432862|NCT00989235|Secondary|Number of Participants Experiencing Disease Relapse|Disease relapse is defined as additional DMARD therapy given, or 2 or more courses of high steroids given, or return to abatacept 10 mg/kg (rescue medication given), or DAS28 CRP score >= 3.2 at 2 consecutive visits.|After 12 Months of treatment|Number of participants analyzed=number randomized.|||Participants|||Number
1432863|NCT00989196|Secondary|Immunogenicity (Number of Patients That Developed an Inhibitor During the Course of the Study)|Inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) at study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for some patients who may finish the study before they achieve 50 EDs), with human-cl rhFVIII (i.e. at the study completion visit).|study entry, then immediately before both PK cycles, in the 48 hour sample of both PK cycles, after 10 to 15 EDs with human-cl rhFVIII, at the 3-month visit (± 2 weeks), then every 3 months (± 2 weeks) until study completion, and after >50 EDs (except for||||participants|||Number
1432879|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12|The number of participants with at least one RBC transfusion during weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).|||Participants|||Number
1432966|NCT00988442|Secondary|Change in CD4 Cell Count at Week 24|Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4.|Baseline and Week 24|Due to early study closure, only 42 participants had week 24 CD4 observations to be included in this analysis.|||cells/mm^3||95% Confidence Interval|Mean
1432864|NCT00989196|Secondary|Efficacy of On-demand Treatment of Bleeding Episodes|"After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 – 12 hours after an infusion requiring up to 2 infusions for complete resolution.~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.~The assessment was made at the end of a BE in case more than one infusion was needed."|From 1st treatment after PK cycle 2 until study end.||||percentage of bleeding episodes|Participants||Number
1432865|NCT00989196|Secondary|Clearance (CL) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||mL/h/kg||Standard Deviation|Mean
1432866|NCT00989196|Secondary|Volume of Distribution at Steady State (Vss) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||mL/kg||Standard Deviation|Mean
1432867|NCT00989196|Secondary|Mean Residence Time (MRT) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||hours||Standard Deviation|Mean
1432868|NCT00989196|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||hours||Standard Deviation|Mean
1432869|NCT00989196|Secondary|Maximum Plasma Concentration (Cmax) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||IU/mL||Standard Deviation|Mean
1432870|NCT00989196|Secondary|Pharmacokinetic Parameter: Invivo Half-life (T1/2) for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||hours||Standard Deviation|Mean
1432871|NCT00989196|Primary|The Area Under the Concentration Curve for Human-cl rhFVIII Compared to Kogenate FS|After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.|At baseline (prior to infusion), 0.25, 0.5, 0.75, 1, 3, 6, 9, 12, 24, 30 and 48 hours after the end of the infusion.||||h IU/mL (IU/kg)||Standard Deviation|Mean
1432872|NCT00989157|Primary|T1/2|Half life|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||hours||Standard Deviation|Mean
1432873|NCT00989157|Primary|AUCo-inf,|Area under the plasma concentration time curve|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||ng h/mL||Standard Deviation|Mean
1432874|NCT00989157|Primary|Tmax|Time to maximum plasma concentration|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||Hours||Standard Deviation|Mean
1432875|NCT00989157|Secondary|Emesis|episodes of emesis.|4 days||||number of occurences|||Number
1432876|NCT00989157|Primary|Cmax|The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72||||ng/ml||Standard Deviation|Mean
1432877|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During Weeks 5-12|The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of Week 5 (Study Day 29).|||days||Standard Deviation|Mean
1432878|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During Weeks 5-12|The number of standard units of RBCs transfused during Weeks 5 to 12.|Weeks 5-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and who were on-study as of the beginning of week 5 (study day 29).|||units of red blood cells||Standard Deviation|Mean
1432903|NCT00988858|Secondary|PK: Maximum Plasma Concentration (Cmax) of Pemetrexed||Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr|All randomized participants who received at least 1 dose of drug and evaluable PK data.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1432880|NCT00989092|Secondary|Number of Days of Red Blood Cell Transfusions During the Test Period|The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.|||days||Standard Deviation|Mean
1432881|NCT00989092|Secondary|Number of Units of Red Blood Cells Transfused During the Test Period|The average number of standard units of red blood cells transfused during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm.|||units of red blood cells||Standard Deviation|Mean
1432882|NCT00989092|Primary|Number of Hospitalizations During the Test Period|Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.|||hospitalizations||Standard Deviation|Mean
1432883|NCT00989092|Primary|Days of Hospitalization During the Test Period|Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.|||days||Standard Deviation|Mean
1432884|NCT00989092|Secondary|Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period|Number of participants with at least one RBC transfusion during Weeks 1 to 12.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm with available data.|||Participants|||Number
1432885|NCT00989092|Secondary|Change From Baseline in Hemoglobin Level|The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion. LVCF imputation was used.|||g/dL||Standard Deviation|Mean
1432886|NCT00989092|Secondary|Hematopoietic Response During the Test Period|The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.|||Participants|||Number
1432887|NCT00989092|Secondary|Hemoglobin Response During the Test Period|The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have a baseline hemoglobin that was not affected by a red blood cell transfusion.|||Participants|||Number
1432888|NCT00989092|Secondary|Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13|The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy. Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.|Baseline (Week 1) and Week 13|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Participants also needed to have completed the baseline and at least 1 post-baseline FACT-Fatigue questionaire. Last Value Carried Forward (LVCF) imputation used.|||units on a scale||Standard Deviation|Mean
1432889|NCT00989092|Secondary|Total Hospital Costs During the Test Period|The hospital bill database was used to determine the mean total hospital cost per participant during the test period. Participants who were not hospitalized had a cost of $0 imputed.|Weeks 1-12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm, and were included in the hospital bill database. Participants who were not hospitalized had a cost of $0 imputed.|||dollars||Standard Deviation|Mean
1432890|NCT00989092|Primary|Number of Participants Hospitalized During the Test Period|Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.|Weeks 1- 12|Includes all randomized patients in the darbepoetin alfa arm who received at least 1 dose of study drug or all randomized patients in the observation arm. Patients also needed to have completed the baseline and at least 1 post-baseline subject outcome questionaire.|||Participants|||Number
1432891|NCT00989014|Primary|Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.||Baseline and every hour for 12 hours following application||||participants|||Number
1432892|NCT00988884|Secondary|Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™|Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves >50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||Titer||95% Confidence Interval|Geometric Mean
1432942|NCT00988442|Secondary|Quality of Life Measured by Euro-QoL - Anxiety/Depression|Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.|Week 24|Available data from participants who made it to week 24 are summarized.|||Participants|||Count of Participants
1432893|NCT00988884|Secondary|Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503|Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8.|Month 7|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
1432894|NCT00988884|Primary|Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)|For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.|Up to 5 days following the Day 1 and Month 1 vaccination / visit|The population analyzed included all vaccinated participants with follow-up|||Percentage of participants|||Number
1432895|NCT00988884|Primary|Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination.|Day 1 through Day 5 following Day 1 or Month 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs|||Percentage of participants|||Number
1432896|NCT00988884|Primary|Percentage of Participants With a V503 Injection-site Adverse Experience|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.|Day 1 through Day 5 following Day 1 vaccination|The population analyzed included all vaccinated participants with follow-up for injection-site AEs|||Percentage of participants|||Number
1432897|NCT00988884|Primary|Geometric Mean Titers of Pertussis Antibody Responses|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||ELU/mL||Full Range|Geometric Mean
1432898|NCT00988884|Primary|Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody|For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of >=0.1 IU/mL.|4 weeks following Day 1 or Month 1 vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
1432899|NCT00988884|Primary|Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups|For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving >50% killing in 60 minutes.|Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination|The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint|||Percentage of participants|||Number
1432900|NCT00988884|Primary|Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503|Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks following Month 6 vaccination|The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint|||milli Merck Units/mL||Full Range|Geometric Mean
1432901|NCT00988858|Secondary|PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pemetrexed||Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr|All randomized participants who received at least 1 dose of drug and had evaluable PK data.|||microgram*hour per milliliter (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1432902|NCT00988858|Secondary|PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618||Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of drug and had evaluable PK data|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1446883|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
1432904|NCT00988858|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618||Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2|All randomized participants who received at least 1 dose of drug and evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1432905|NCT00988858|Secondary|Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)|The LCSS participants scale is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS.|Baseline until End of Study (Up to 27.1 Months)|The LCSS evaluable population consisted of all enrolled participants who had a baseline LCSS measurement and at least 1 post-baseline measurement. The population was evaluated for changes in the ASBI (improved, stable, worsened), with improvement/worsening based on trends seen in sets of consecutive ASBI assessments with respect to baseline ASBI.|||participants|||Number
1432906|NCT00988858|Secondary|Duration of Response|Duration of Response is defined as the time from the first observation of CR or PR to the first observation of progressive disease (PD) or death from any cause. A response is defined as a confirmed objective status of CR or PR. For participants who are not known to have died as of the data inclusion cut-off date and who do not have PD, the duration will be censored at the date of the last objective progression free disease assessment prior to the date of any subsequent anticancer therapy.|First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months)|All randomized participants who received at least 1 dose of drug with Best Overall Response of Complete Response or Partial Response.5 participants were censored.|||months||90% Confidence Interval|Median
1432907|NCT00988858|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.|Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months)|All randomized participants who received at least 1 dose of drug. 9 participants were censored.|||months||90% Confidence Interval|Median
1432908|NCT00988858|Secondary|Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)|Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)|All randomized participants who received at least 1 dose of drug.|||percentage of participants||90% Confidence Interval|Number
1432909|NCT00988858|Primary|Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)|All randomized participants who received at least 1 dose of drug.|||percentage of participants||95% Confidence Interval|Number
1432910|NCT00988832|Primary|Mean Cost Per Participant for Diagnostic Tests During Planned Outpatient Consultations|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of diagnostic tests conducted during outpatient consultations were calculated as per the 2008-2009 NHS Reference Costs. Costs for diagnostic tests during hospitalizations and A&E visits were incorporated into cost analyses for those categories and are not included here.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432911|NCT00988832|Primary|Mean Cost Per Participant for Crohns-related Medications|Costs of biologics were calculated by multiplying the number of vials of drug used per participant by the 2009 British National Formulary (BNF) cost per vial. Costs of other drugs with ≥10 prescriptions were calculated by multiplying the 2009 BNF daily cost of the standard/most-prescribed dose of the most-prescribed drug (reference drug) in each drug group (Anatomical Therapeutic Classification [ATC] Level 4) by the length of treatment. Costs for drugs in drug groups with ≤9 prescriptions were calculated using the average cost of all Crohns medications multiplied by the length of treatment.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432912|NCT00988832|Primary|Mean Cost Per Participant of Accident and Emergency (A&E) Visits|Costs for visits to A&E without admission. Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease as per the 2009 Healthcare Resource Group (HRG) descriptors.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432913|NCT00988832|Primary|Mean Cost Per Participant for All Hospitalizations|"Costs for all hospitalizations, including costs associated with elective~and emergency (non-elective) admissions as well as outpatient procedures."|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432914|NCT00988832|Primary|Mean Cost Per Participant for Admissions for Day Case Surgery|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of day case (outpatient) surgeries were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for any surgeries that did not require the participant to stay overnight in the hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432915|NCT00988832|Primary|Mean Cost Per Participant Due to Non-elective/Emergency Inpatient Admissions|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of non-elective or emergency inpatient admissions were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for unplanned hospital admissions due to emergency surgical procedures and unplanned consultations due to complications.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432916|NCT00988832|Primary|Mean Cost Per Participant of Elective Surgical Procedures|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of elective surgical procedures were calculated as per the 2009 Healthcare Resource Group (HRG) descriptors. Costs were analyzed for elective surgeries that required participants to be admitted into a hospital.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432917|NCT00988832|Primary|Mean Cost Per Participant of Consultations With Health Care Providers (HCPs)|Costs were calculated as those incurred to the National Health Service (NHS) to treat Crohn's Disease. Costs of outpatient consultations are based on the 2009 Unit Cost of Health and Social Care published by the Personal Social Service Research Unit. Consultations with gastroenterologists, gastric/gastrointestinal surgeons, radiologists, nurses/Inflammatory Bowel Disease nurses, dieticians/nutrition specialists, psychologists/psychiatrists, pharmacists, and occupational therapists are included in the analysis.|12 months prior to and 12, 18, and 24 months after the first infusion of infliximab||||Pounds sterling per participant||Standard Deviation|Mean
1432918|NCT00988637|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4|Number of participants with Tolerability Assessments resulting in Adverse Events from baseline to week 4. Tolerability assessments (Pruritus, telangiectasias, and stinging/burning) are evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 3 being worst. Skin atrophy and folliculitis are evaluated as absent or present. Changes in tolerability assessments that require a dose modification or concomitant medications/therapy are recorded as adverse events.|Baseline to Week 4|Safety|||participants|||Number
1432919|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I Would Use This Treatment Program Again if Recommended by the Dermatologist at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I would use this treatment program again if recommended by the dermatologist at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)|||participants|||Number
1432920|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With the Results of This Treatment Program at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am satisfied with the results of this treatment program at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)|||participants|||Number
1432921|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question I am Satisfied With my Appearance at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question I am Satisfied with my Appearance at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Week 4|ITT (Intent to Treat)|||participants|||Number
1432922|NCT00988637|Secondary|"Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question The Treatment Program Was Easy to Follow at Week 4"|"Number of participants who responded to the categories of possible answers to the Subject's Satisfaction Survey question The treatment program was easy to follow at Week 4. Categories of possible answers include Strongly agree, Moderately agree, No opinion, Moderately disagree, and Strongly disagree."|Baseline and Week 4|ITT (Intent to Treat)|||participants|||Number
1432923|NCT00988637|Secondary|Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4|Mean change from baseline scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) from Baseline to Week 4. The Koo-Menter Psoriasis Index is a questionnaire with 12 questions that can be used to assess the effect that psoriasis has on a patient's overall quality of life. The questions are answered on a scale from 0 to 10 with 0 being best and 10 being worst.|Baseline to Week 4|ITT (Intent to Treat)|||Units on a scale||Standard Deviation|Mean
1432924|NCT00988637|Secondary|Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4|Median percent (%) change from baseline in % treatable BSA (Body Surface Area) from Baseline to Week 4|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||Percent change||Standard Deviation|Median
1432925|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Plaque Elevation) scores from Baseline to Week 4. Signs of Psoriasis (Plaque Elevation) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||participants|||Number
1432926|NCT00988637|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4|Number of participants with decrease in Signs of Psoriasis (Scaling) scores from Baseline to Week 4. Signs of Psoriasis (Scaling) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||participants|||Number
1432927|NCT00988637|Secondary|Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4|Number of participants with a decrease in Signs of Psoriasis (Erythema) scores from Baseline to Week 4. Signs of Psoriasis (Erythema) are evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat; LOCF (Last Observation Carried Forward)|||participants|||Number
1432928|NCT00988637|Secondary|Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4|Number of participants in each category of the Global Assessment of Improvement (GAI) Scale from Baseline to Week 4. The Global Assessment of Improvement is evaluated on a scale from -1 to 4 (-1 = Symptoms worse, 0 = No change, 1 = Minimal Improvement, 2 = Definite Improvement, 3 = Considerable Improvement and 4 = Clearing) with -1 being worst and 4 being best.|Baseline to Week 4|ITT (Intent to Treat); LOCF (Last Observation Carried Forward)|||participants|||Number
1432929|NCT00988637|Secondary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 based on the Overall Disease Severity (ODS), dichotomized scale from Baseline to Week 2. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to week 2|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1432930|NCT00988637|Primary|Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4|Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.|Baseline to Week 4|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1432931|NCT00988559|Secondary|Absence of CIN2/3 Lesion by Week 15|Number of participants with no CIN2/3 lesion at the week 15 visit|15 weeks|Number of participants who had no CIN2/3 at the week 15 resection|||Participants|||Count of Participants
1432932|NCT00988559|Primary|Number of Participants With Related Serious Adverse Events|Presence of intervention-related serious adverse events as defined by CTCAE|9 months|Related Serious Adverse Events|||Participants|||Count of Participants
1432933|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Time of Observed Maximum Plasma Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||hour||Standard Deviation|Mean
1432934|NCT00988533|Primary|Summary of Pharmacokinetic Parameter (Mean Concentration) Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||ng/mL||Standard Deviation|Mean
1432935|NCT00988533|Secondary|Liver Function Test Results at Before (Baseline) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function test (total bilirubin) was performed before treatment Day 1 (baseline) and following Ivermectin application on Days 2, 8, and 15 Post-application, respectively.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.|||mg/dL||Standard Deviation|Mean
1432936|NCT00988533|Secondary|Liver Function Test Results at Before (Day 1) and Following Ivermectin Application on Days 2, 8, and 15 Post-application|Liver function tests (Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase) were performed before Ivermectin application on Day 1 (baseline) and on Days 2, 8, and 15 after application.|Day 1, Day 2, Day 8 and Day 15 post-application|Liver function tests were performed in the intent to treat population.|||U/L||Standard Deviation|Mean
1432937|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 8 and Day 15 Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair before and following application of Ivermectin.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent to treat population.|||Percent of Participants|||Number
1432938|NCT00988533|Secondary|Percentage of Participants Who Were Lice-Free by Visit Post-treatment With Ivermectin.|Eradication of live lice was assessed by visual examination of the scalp and hair.|Day 2, Day 8 and Day 15 post-application|Eradication of live lice was assessed in the intent-to-treat population.|||Percent of Participants|||Number
1432939|NCT00988533|Secondary|Number of Participants Reporting Adverse Events Following Ivermectin Treatment|Adverse events were assessed at each visit and during the follow up phone call on Day 28.|Day 1 up Day 28 post-application|Adverse events were assessed in the intent-to-treat population.|||Participants|||Number
1432940|NCT00988533|Primary|Summary of Pharmacokinetic Parameters Following Ivermectin Application.|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods before application and on Day 1 (0.5, 1, and 6 hours post-application), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours, Day 8 and Day 15 post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||ng/h/mL||Standard Deviation|Mean
1432941|NCT00988533|Primary|Mean Plasma Concentration of Ivermectin in Samples Collected Before Application and at Specified Post-Application Time Points|Plasma concentrations of ivermectin were measured by validated and appropriate bioanalytical instruments and methods with a sensitivity of 0.05 ng/mL before application and on Day 1 (0.5, 1, and 6 hours), Day 2 (24 hours post-application), Day 8 (7 days post-application), and Day 15 (14 days post-application).|Before; 0.5, 1, 6, 24 hours and Up to 14 days post-application|Plasma concentrations of Ivermectin were assessed in the pharmacokinetic (PK) population.|||ng/mL||Standard Deviation|Mean
1432947|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale|ARV medication adherence at Week 24, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.|Week 24|Due to early study closure, only 40 participants had adherence data available at week 24 for this outcome.|||percentage of HIV meds taken last month||Inter-Quartile Range|Median
1432948|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale|ARV medication adherence at week 12, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month.|Week 12|Due to early study closure, only 44 participants had adherence data available at week 12 for this outcome.|||percentage of HIV meds taken last month||Inter-Quartile Range|Median
1432949|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall|"ARV medication adherence, as measured by four day recall, i.e. Missed doses in last 4 days."|Week 24|Due to early study closure, only 39 participants had adherence data at week 24.|||Participants|||Count of Participants
1432950|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall|"ARV medication adherence at week 12, as measured by four day recall, i.e. Missed doses in last 4 days."|Week 12|Due to early study closure, only 42 participants had adherence data at week 12 for this outcome.|||Participants|||Count of Participants
1432951|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire|ARV medication adherence at week 24, as measured by the ACTG adherence questionnaire index. The ACTG adherence questionnaire index is on a 0-100 scale where higher scores indicate better adherence.|Week 24|Due to early study closure, 31 participants had complete adherence data for this outcome.|||units on a scale||Inter-Quartile Range|Median
1432952|NCT00988442|Secondary|Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire|ARV medication adherence at week 12, as measured by the ACTG adherence questionnaire index. This questionnaire index is on a 0-100 scale, with higher scores indicating higher adherence.|Week 12|Due to early study closure, only 30 participants had complete adherence data for this outcome.|||units on a scale||Inter-Quartile Range|Median
1432953|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 48.|Measured at Week 48|Due to early study closure, only the 14 participants that reached week 48 with available data were included in this analysis.|||Participants|||Count of Participants
1432954|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 24.|Week 24|Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.|||Participants|||Count of Participants
1432955|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12|Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 12.|Week 12|Due to early study closure, only the 43 participants who reached week 12 with available data were included in this analysis.|||Participants|||Count of Participants
1432956|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.|Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 24.|Week 24|Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.|||Participants|||Count of Participants
1432957|NCT00988442|Secondary|Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12|Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12.|Week 12|Due to early study closure, only the 43 participants who reached week 12 with available virologic data were included in this analysis.|||Participants|||Count of Participants
1432958|NCT00988442|Secondary|Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)|Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall.|Week 12|Only participants in the telephone support group were analyzed.|||minutes||Inter-Quartile Range|Median
1432959|NCT00988442|Secondary|Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)|Intervention dosage score for enhanced nursing telephone support. This is the total percentage of scheduled calls successfully delivered.|Measured at Week 12|Only participants in the telephone support group were analyzed.|||percent of scheduled calls delivered||Standard Deviation|Mean
1432960|NCT00988442|Secondary|Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period|Number of participants whose last telephone call received occurred prior to the end of the defined intervention period.|Measured from entry to Week 72 or premature study discontinuation|Only participants in the telephone support group were analyzed.|||participants|||Number
1432961|NCT00988442|Secondary|Number of Participants With Virological Suppression|Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL.|Measured from entry to Week 72 or premature study discontinuation|All participants with scheduled post baseline HIV-1 RNA measurements.|||participants|||Number
1432962|NCT00988442|Secondary|Number of Participants With Illness Events or Mortality|Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive.|Measured from entry to Week 72 or premature study discontinuation|Due to early study closure, only 59 participants were accrued and followed on study.|||Participants|||Count of Participants
1432963|NCT00988442|Secondary|Cost of the Adherence Telephone Interventions|This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful.|Week 48|This outcome was not analyzed, since the intervention was not determined to be successful.||||||
1432964|NCT00988442|Secondary|Confirmed Virologic Failure|Number of participants with confirmed virologic failure. Virologic failure is defined as confirmed HIV-1 RNA ≥200 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 20 weeks after the date of randomization).|Week 24 through Week 72|The analysis population was all participants randomized to a treatment arm in this trial.|||Participants|||Count of Participants
1432967|NCT00988442|Secondary|Change in CD4 Cell Count at Week 12|Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4.|Baseline and Week 12|Due to early study closure, only 44 participants had week 12 CD4 observations to be included in this analysis.|||cells/mm^3||95% Confidence Interval|Mean
1432968|NCT00988442|Secondary|Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation|Number of premature ART regimen discontinuations, defined as the first substitution, subtraction, or addition of one or more ARVs made to the initial study regimen.|From study entry to Week 72|All participants with available ART data.|||participants|||Number
1432969|NCT00988442|Primary|Number of Participants With Virologic Suppression|Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.|Week 48|All participants enrolled who had Week 48 HIV-1 RNA results available were included in this intent-to-treat-analysis. At the time of early study closure, 14 participants had reached week 48.|||Participants|||Count of Participants
1432970|NCT00988429|Secondary|Proportion of Responders|Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.|Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||percentage of participants||95% Confidence Interval|Number
1432971|NCT00988429|Primary|Seizure Frequency Over the 12-week Maintenance Period.||12-week maintenance period (Week 3 to week 14)|Intent-to-treat (ITT) population was the primary population for the analysis of efficacy; ITT included all randomized subjects who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||Nº Standardized Seizures by 4 weeks||Standard Error|Least Squares Mean
1432972|NCT00988351|Secondary|Treatment Pressure (Level of CPAP or 90th Percentile APAP)|The level of CPAP used for treatment versus the 90th percentile pressure used during APAP. The 90th percentile pressure is the value that is used if one converts a patient from APAP to CPAP.|6 weeks clinic|participants using PAP at the 6 weeks clinic visit|||cm H2O||Standard Deviation|Mean
1432973|NCT00988351|Secondary|Residual Apnea-hypopnea Index|The PAP device estimate of residual apnea-hypopnea index (AHI, number of apneas and hypopneas per hour of patient use) an estimate of effectiveness of treatment. An AHI < 10 is considered adequate treatment and <5/hour ideal treatment.|over first 6 weeks of treatment|participants using PAP at clinic visit (>= 1/2 hour of nightly use)|||events (apneas+hypopneas)/hour||Standard Deviation|Mean
1432974|NCT00988351|Secondary|Change in Functional Outcomes of Sleep Questionnaire|The functional outcomes of sleep questionnaire (FOSQ) is a standard quality of life measure used to assess improvement in quality of life after treatment for sleep disorders. The total FOSQ score was analyzed. The range if 5 to 20. A higher score is a better quality of life. This analysis compares the change after treatment (post treatment FOSQ - pretreatment FOSQ). A positive difference indicates an improve in the quality of life.|6 weeks at clinic|Using PAP 1/2 hour or more nightly|||units on a scale||Standard Deviation|Mean
1432975|NCT00988351|Secondary|Change in Epworth Sleepiness Scale|Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. The change in the ESS = post-treatment value - pre-treatment value. A decrease in the ESS (negative change) is consistent with less sleepiness.|6 weeks after starting treatment||||units on a scale||Standard Deviation|Mean
1432976|NCT00988351|Primary|Positive Airway Pressure Adherence (Nightly Use of Treatment)|average nightly hours of using positive airway pressure (including 0 for nights not used)|6 weeks after starting treatment|patients using cpap or apap at clinic visit|||hours||Standard Deviation|Mean
1432977|NCT00988325|Secondary|Number of Participants Showing Within-patient Variability in Vital Signs|Systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, and heart rate were examined for any consistent within-patient post-baseline changes.|Post baseline, Day 3, 4, 6, 11, 18+/- 2 days, 30+/-2 days|Safety population included all treated participants with at least one post-baseline safety assessment. Due to the small numbers of participants and the extent of influenza induced variability, changes in vital sign patterns cannot be detected.||||||
1432978|NCT00988325|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Secondary Illness|An Adverse Event (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Secondary illnesses were influenza disease-related events, namely bronchitis, pneumonia, otitis media, and sinusitis that resolved without sequelae. Adverse events, serious adverse events, and secondary illness are reported for on-treatment period (from the first dose of oseltamivir upto 3 days after the last dose of oseltamivir [Approximately 14 days].|Up to 3 days after the last dose of oseltamivir (Approximately 14 days)|Safety population included all treated participants with at least one post-baseline safety assessment|||Participants|||Number
1432979|NCT00988325|Secondary|Percentage of Participants With Decline of Body Temperature to the Afebrile State|This was performed for all participants who had fever at baseline Fever is defined as body temperature >37.0ºC. Rectal temperature is converted by subtracting 1 ºC. The rate of decline of body temperature was calculated as the slope of body temperature between the baseline temperature and the 1st temperature below 37°C. Participants with decline in body temperature were considered to have no fever; however, participants who did not show any decline in body temperature were considered to have persisting fever.|Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 days|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||percentage of participants|||Number
1433139|NCT00986986|Primary|Change in Flow-mediated Vasodilation (FMD) From Baseline to Study Week 12|Brachial arterial flow-mediated dilation (FMD), assessed by high-resolution ultrasonography, reflects endothelium-dependent vasodilator function. The primary outcome is the change in FMD from baseline to study week 12.|Two time points (baseline and study week 12)|HIV infected patients with HDL-C < 40|||percentage change in FMD||Inter-Quartile Range|Median
1432980|NCT00988325|Secondary|Time to Resolution of Fever in Participants With Fever at the Baseline|This was performed for all participants who had fever at baseline. Fever is defined as body temperature >37.0 degree Celsius. Rectal temperature is converted by subtracting 1 degree Celsius. Time to Resolution of Fever was defined as the time from the initiation of treatment to first time the afebrile state was reached and maintained for at least 21.5 hours, where afebrile state was defined as axillary temperature ≤ 37 degree Celsius.|Days 1 to 11; Day 18; Day 30|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||hours||Full Range|Median
1432981|NCT00988325|Secondary|Number of Participants With Virus Shedding by Virus Type|The viral titer was measured by culture and reported in log10 (50% tissue culture infective dose [TCID50]). The viral load was analyzed by PCR and reported as log10 particles/mL. The number of patients positive for viral shedding by virus sub-type was measured on specified days from baseline to last visit on Day 30.|Baseline (Day 1), Day3/4, Day 6, Day 11, Day 18+/-2 days, Day 30+/-2 days|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||Participants|||Number
1432982|NCT00988325|Secondary|Median Time to Cessation of Viral Shedding in Participants With Positive Culture at Baseline|Median time to cessation of viral shedding was calculated for all patients with positive by culture / by polymerase chain reaction (PCR) at baseline using all data points between the start of the treatment and the 1st time point of negative culture without subsequent positive culture results. These time-to event analyses were only performed for the viral titre.|Days 1, 3 or 4, 6, 11, 18, and 30|Pharmacodynamic Analysis Population consisted of all enrolled participants with a positive influenza infection confirmed by culture or PCR at baseline or anytime during the study|||hours||95% Confidence Interval|Median
1432983|NCT00988325|Secondary|Number of Participants With Change From Baseline in Neurological Assessment Scores|Neurological assessment was performed to assess the mental state of the participants through two scales: Infant face scale and Glasgow coma scale. Each scale consists of 3 subscales: eye opening (ranging 1 to 4), verbal response (ranging 1 to 5), and motor responses (ranging 1 to 6). The final score is the sum of these ranges and is scored between 3 and 15. 3 being the worst, and 15 the best. Change from baseline is change of final score post-baseline minus the final score at baseline.|Baseline (Day 1); Day 3 for who received two does on Day 1 or Day 4 for who received one dose on Day 1; Day 6, Day 11, Day 18, Day 30|Safety population included all treated participants with at least one post-baseline safety assessment|||participants|||Number
1432984|NCT00988325|Secondary|Time of the Last Measurable Plasma Concentration for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.|||hours||Geometric Coefficient of Variation|Geometric Mean
1432985|NCT00988325|Secondary|Clast of Oseltamivir and Oseltamivir Carboxylate|The last measurable plasma concentration of oseltamivir and oseltamivir carboxylate was the last quantifiable concentration of oseltamivir or oseltamivir carboxylate, respectively.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated patients with at least one blood sample evaluable for drug concentration level and who were adhered to the protocol|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1432986|NCT00988325|Secondary|The Volume of Distribution as a Function of Bioavailability of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.|||mL||Geometric Coefficient of Variation|Geometric Mean
1432987|NCT00988325|Secondary|Total Plasma Clearance as a Function of Bioavailability and Apparent Plasma Clearance of the Metabolite as a Function of Bioavailability (CLm/F) of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. CL/F was calculated as dose/AUCinf, where AUCinf represents the area under the concentration-time curve of the analyte in plasma over the time interval from zero extrapolated to infinity|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||mL/hour||Standard Deviation|Mean
1432988|NCT00988325|Primary|Steady-state Minimum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. Cmin was estimated for both oseltamivir and oseltamivir carboxylate by non-compartmental analysis|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1433056|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 21 post-vaccination|Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.|||Participants|||Number
1432989|NCT00988325|Primary|Steady-state Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir. Cmax was estimated for both oseltamivir and Oseltamivir carboxylate by non-compartmental analysis.|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1432990|NCT00988325|Secondary|Apparent First-order Elimination Rate Constant of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir.The apparent first-order elimination rate constant (Lambda Z) was determined by linear regression analysis of terminal data points. A minimum of 3 data points were used for lambda Z estimation. By reporting tool convention, if n<3, no summary statistics were calculated|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
1432991|NCT00988325|Secondary|Apparent Elimination Half Life of Oseltamivir and Oseltamivir Carboxylate|Elimination half-life is defined as the time required for elimination of a drug to half its plasma concentration and was computed using non-compartmental method|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/-15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||hours||Geometric Coefficient of Variation|Geometric Mean
1432992|NCT00988325|Secondary|Time to the Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.Tmax was estimated using non-compartmental methods|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||hours||Full Range|Median
1432993|NCT00988325|Primary|Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule|15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Pharmacokinetic (PK) population included all treated participants with at least one blood sample evaluable for drug concentration level and who adhered to the protocol. n = participants with evaluable drug concentration|||hour (h)*nanogram(ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
1432994|NCT00988247|Secondary|Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 52 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 52|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
1432995|NCT00988247|Secondary|Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline|"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 30 scores were compared to baseline scores. A negative change score indicates improvement."|Day 0 (Baseline) and Week 30|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at Day 0 of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
1432996|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1432997|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 52|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
1432998|NCT00988247|Secondary|Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1432999|NCT00988247|Primary|Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement."|Baseline (Days -6 to 0), Day 1 to Week 30|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1433000|NCT00988221|Secondary|Height Standard Deviation Score at Baseline, Week 52, and Week 104|The height Standard Deviation Score was calculated using the following formula: (Observed height - median of the reference population)/standard deviation of the reference population. The reference population was defined as that of the same sex and age to the nearest completed year and month using the World Health Organization norms. A negative score indicates less height than the reference population.|Baseline to Week 104|Growth population: All participants who received at least 1 dose of tocilizumab but who did not take the growth hormone somatotropin.|||Standard deviation score||Standard Deviation|Mean
1433001|NCT00988221|Secondary|Methotrexate Dose at Baseline, Week 52, and Week 104|Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.|||mg/m^2/week||Standard Deviation|Mean
1433002|NCT00988221|Secondary|Oral Corticosteroid Dose at Baseline, Week 52, and Week 104|Due to the different types of corticosteroid medications available, the prednisone equivalent was used in the calculation of the oral corticosteroid dose. Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.|Baseline to Week 104|All exposure safety population: All patients randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.|||mg/kg/day||Standard Deviation|Mean
1433003|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.|||Percent of patients|||Number
1433004|NCT00988221|Secondary|Percent of Patients in Clinical Remission From Week 40 to 104|A patient was in clinical remission if they had inactive disease at all visits in the 6 months prior to and including the visit assessment day. A patient was judged to have inactive disease if all of the following criteria were met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 40 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.|||Percent of patients|||Number
1433005|NCT00988221|Secondary|Percent of Patients With Inactive Disease From Week 16 to Week 104|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.|Week 16 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.|||Percent of patients|||Number
1433086|NCT00987935|Secondary|Progression Free Survival (PFS)|PFS by RECIST 1.0 was defined as the duration from date of randomisation to date of progression or death, whichever occurred earlier, based on central independent review.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.|||months||Inter-Quartile Range|Median
1433006|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Units on a scale||Standard Deviation|Mean
1433007|NCT00988221|Secondary|C-reactive Protein Levels From Baseline to Week 104|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.|||mg/L||Standard Deviation|Mean
1433008|NCT00988221|Secondary|Percent of Patients With a Minimally Important Improvement in the Children’s Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104|The CHAQ-DI consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A minimally important improvement is an improvement ≥ 0.13 over Baseline. Patients who withdrew due to non-safety reasons are classified as non-responders.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.|||Percent of patients|||Number
1433009|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at Week 104|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Percent change||Standard Deviation|Mean
1433010|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at Week 104|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Percent change||Standard Deviation|Mean
1433011|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at Week 104|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.|||Percent change||Standard Deviation|Mean
1433012|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at Week 104|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.|||Percent change||Standard Deviation|Mean
1433087|NCT00987935|Secondary|Objective Tumour Response by RECIST|"Objective RECIST 1.0 tumour response was defined as Complete Response (CR) or Partial Response (PR) and was derived from the patient's best objective RECIST 1.0 response based on central independent review.~95% Confidence Interval presented below are computed by Clopper and Pearson method."|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, only phase II participants.|||percentage of participants||95% Confidence Interval|Number
1433013|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at Week 104|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.|||Percent change||Standard Deviation|Mean
1433014|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at Week 104|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A negative change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.|||Percent change||Standard Deviation|Mean
1433015|NCT00988221|Secondary|Change From Baseline in the Juvenile Arthritis Disease Activity Score-71 (JADAS-71) at Week 104|The JADAS-71 is composed of 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range = 0-10, left end of the line = arthritis inactive, ie, symptom-free and no arthritis symptoms; right end = arthritis very active), patient/parent global assessment of overall well-being on a VAS (range = 0-10, left end of the line = very well, ie, symptom-free and no arthritis disease activity; right end = very poor, ie, maximum arthritis disease activity), normalized erythrocyte sedimentation rate (ESR) (range = 0-10, If ESR is ≤ 20 mm/h, set to 0. If ≥ 120 mm/h, set to 10 mm/h. If > 20 mm/h and < 120 mm/h, apply formula: [ESR − 20 mm/h]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). The JADAS-71 is the sum of the 4 component scores and ranges from 0-101. A higher score indicates more arthritis disease activity. A positive change score indicates improvement.|Baseline to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Only patients with non-missing data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1433016|NCT00988221|Secondary|Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Results are reported for the subgroups: Previous biologic treatment (yes/no), concomitant methotrexate use (yes/no), rheumatoid factor (positive/negative), concomitant oral corticosteroid use (yes/no). Last observation carried forward was applied to missing components at visits.|Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.|||Percent of patients|||Number
1433017|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Week 2 to Week 104|Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study.|||Percent of patients|||Number
1433018|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part II of the Study (Week 40)|"A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10.~The statistical test is not significant due to a break in the hierarchical chain of significance testing."|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Percent of patients||95% Confidence Interval|Number
1433036|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part I of the Study (Week 16)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
1433019|NCT00988221|Secondary|Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward (LOCF) imputation for missing values. The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids, and the pain visual analog scale score at Baseline. The adjusted means from the fitted model are presented.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
1433020|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) at the End of Part II of the Study (Week 40)|The Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
1433021|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part II of the Study (Week 40)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||mm/hour||Standard Deviation|Mean
1433022|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part II of the Study (Week 40)|Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Joints||Standard Deviation|Mean
1433023|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part II of the Study (Week 40)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Joints||Standard Deviation|Mean
1433024|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part II of the Study (Week 40)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
1433025|NCT00988221|Secondary|Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part II of the Study (Week 40)|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.|Baseline to Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Units on a scale||Standard Deviation|Mean
1433088|NCT00987935|Secondary|Incidence of Dose Limiting Toxicity in Phase I|Number of patients with dose limiting toxicity are presented|4 weeks|Treated set (Phase I patients from the dose escalation part that were not replaced for MTD determination).|||participants|||Number
1433193|NCT00986427|Secondary|Growth of the Treated and Untreated Nail in the Previous 4 Weeks|Growth of the treated and untreated nail the previous 4 weeks. Nail growth was measured in millimeters.|Week 24||||Millimeters (mm)||Standard Deviation|Mean
1433026|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Percent of patients||95% Confidence Interval|Number
1433027|NCT00988221|Secondary|Percent of Patients With an Elevated White Blood Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|White blood cells were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
1433028|NCT00988221|Secondary|Percent of Patients With an Elevated Platelet Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Platelets were measured in blood samples taken from the patients.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
1433029|NCT00988221|Secondary|Percent of Patients With an Elevated Erythrocyte Sedimentation Rate at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
1433030|NCT00988221|Secondary|Percent of Patients With an Elevated C-reactive Protein Concentration at Baseline That Had Normalized at the End of Part I of the Study (Week 16)|C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
1433031|NCT00988221|Secondary|Percent of Patients With Inactive Disease at the End of Part I of the Study (Week 16)|A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms ‘uveitis’ and ‘intermediate uveitis’; normal erythrocyte sedimentation rate (< 20 mm/hour regardless of age and sex); and physician’s global assessment of overall well-being visual analog scale score ≤ 10.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
1433032|NCT00988221|Secondary|Pain Visual Analogue Scale (VAS) Score at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘no pain’ and the extreme right end represents ‘very extreme pain’. A higher score indicates more pain.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Units on a scale||Standard Deviation|Mean
1433033|NCT00988221|Secondary|Juvenile Arthritis Disease Activity Score (JADAS-27) at the End of Part I of the Study (Week 16)|The JADAS-27 is derived from the following components: Physician’s global assessment of disease activity on a 0-100 mm visual analog scale (VAS)/10, patient/parent’s global assessment of overall well-being on a 0-100 mm VAS/10, normalized erythrocyte sedimentation rate (ESR) (if ESR is ≤ 20 then set to 0, if ≥ 120 then set to 10, and if > 20 and < 120 then apply formula [ESR-20]/10), and number of joints (maximum of 27) with active arthritis (cervical spine, left/right elbow, left/right wrist, left/right MCP1-3, left/right PIP1-5, left/right hips, left/right knee and left/right ankle). The scores for the first 3 components range from 0-10; the score for the final component ranges from 0-27. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Units on a scale||Standard Deviation|Mean
1433034|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at the End of Part I of the Study (Week 16)|Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
1433035|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part I of the Study (Week 16)|Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
1433037|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part I of the Study (Week 16)|Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient’s efficacy and safety data. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
1433038|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part I of the Study (Week 16)|The patient or parent/guardian, as appropriate, provides a rating of the patient’s well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘very well’ (ie, symptom-free and no arthritis disease activity) and the extreme right end represents ‘very poor’ (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
1433039|NCT00988221|Secondary|Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16)|The patient’s treating physician provides a rating of the patient’s arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents ‘arthritis inactive’ (ie, symptom-free and no arthritis symptoms) and the extreme right end represents ‘arthritis very active’. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent change||Standard Deviation|Mean
1433040|NCT00988221|Secondary|Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16)|A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]).|Baseline to Week 16|Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.|||Percent of patients|||Number
1433041|NCT00988221|Primary|Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40)|JIA ACR30 flare is defined as a ≥ 30% worsening of 3 of 6 variables and no more than 1 of the remaining variables improving > 30%. The 6 variables are physician global assessment of disease activity (worsening of 20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (worsening of 20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew or who took escape medication are classified as flared. The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.|Week 16 through Week 40|Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.|||Percent of patients||95% Confidence Interval|Number
1433042|NCT00988208|Secondary|Time to Onset of Secondary Primary Malignancies|Time of Onset of Secondary Primary Malignancies was considered an event of interest|The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).|||months||Full Range|Median
1433043|NCT00988208|Secondary|Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial|Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.|The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment lenalidomide/placebo, Docetaxel, or Prednisone).|||percentage of participants|||Number
1433044|NCT00988208|Secondary|Percentage of Participants Who Received Post-Study Therapies|Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.|The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).|||Percentage of Participants|Participants||Number
1433055|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1433106|NCT00987480|Primary|The Incidence of Early Transplant Related Mortality||2 years||||Participants|||Count of Participants
1433045|NCT00988208|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;|From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL|The Safety Population is defined as all randomized participants who receive at least one dose of the study treatment (lenalidomide/placebo, Docetaxel, or Prednisone).|||participants|||Number
1433046|NCT00988208|Secondary|Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria|Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones|From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months|Based on the ITT population|||percentage of participants|||Number
1433047|NCT00988208|Secondary|Progression-Free Survival (PFS)|PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan|From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months|Based on the Intent to treat population (ITT), defined as all randomized patients irrespective of whether they received treatment or not.|||Weeks||95% Confidence Interval|Median
1433048|NCT00988208|Primary|Overall Survival (OS)|Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.|From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months|Intent-to-Treat (ITT) population defined as all randomized patients irrespective of whether they received treatment or not.|||weeks||95% Confidence Interval|Median
1433049|NCT00988169|Primary|Radiographic Objective Response Rate|(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101|21 days after cycle one||||participants|||Number
1433050|NCT00988156|Primary|Responder Rate|Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|baseline up to Visit 7||||participants|||Number
1433051|NCT00988156|Primary|Change From Baseline in Seizure Frequency|Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.|Baseline up to Visit 7||||seizures/month||Standard Deviation|Mean
1433052|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).|||Titers||95% Confidence Interval|Geometric Mean
1433053|NCT00988143|Other Pre-specified|Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)."|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
1433054|NCT00988143|Other Pre-specified|Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines|Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 up to 21 days post-vaccination|Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Participants|||Number
1433057|NCT00988143|Other Pre-specified|Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants|Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1433058|NCT00988143|Other Pre-specified|Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine|"Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.~Seroprotection to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)"|Day 0 (pre-vaccination) and Day 21 post final vaccination|Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.|||Participants|||Number
1433059|NCT00988143|Primary|Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.|Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.|21 Days post last vaccination|Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1433060|NCT00988143|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.|"Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.~(24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.~(Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.~Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity."|Day 0 up to 7 days post-vaccination|Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.|||Participants|||Number
1433061|NCT00988117|Secondary|Pre-post Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
1433062|NCT00988117|Primary|Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)|On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.|Baseline and 12 weeks|Data were missing for two of the patients on the CPT post-treatment due to a computer error.|||milliseconds||Full Range|Median
1433063|NCT00988117|Primary|Resting State Functional Activity Change From Baseline to 12 Weeks|Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.|Baseline and 12 weeks|All patients who completed the study were included.|||z-score||Standard Deviation|Mean
1433064|NCT00988091|Secondary|Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26|Responders are identified based on a calculation of three scales: 50-foot walk test for pain, function (WOMAC Disability score) and global assessment (Patient Global Assessment Score) scales. Each of the individual scales was completed by the participant. A responder showed considerable improvement in pain or function (>=50 percent and absolute change of >=20 millimeters), or improvement in at least two of three categories: Pain and/or Function and/or Patient Global Assessment scales of >=20 percent and absolute change >=10 millimeter. Response at Week 26 is compared to baseline.|Day 0 (baseline), week 26|Intent to treat population|||percentage of participants|||Number
1433065|NCT00988091|Secondary|Change From Baseline in Patient Global Assessment at Week 26|Participants were asked to mark along a 100mm visual analog scale (VAS) indicating the point best representing the severity of the knee pain that day. The left side of the VAS was 0=no pain and the right side was 100 = extreme pain. Change from baseline was calculated as Week 26 - Baseline.|Day 0 (baseline), Week 26|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1433066|NCT00988091|Secondary|Number of Tablets of Rescue Medication Used Between Visits|Acetaminophen (500-mg tablets) was provided to study participants as a rescue medication in case they needed a pain medication during the study. The mean number of tablets of rescue medication should have been summarized, however the data was not captured in a reliable way and is therefore not reported.|Day 1 to week 26||||tablets||Standard Deviation|Mean
1433067|NCT00988091|Secondary|Subjective Patient Assessment of Treatment at Week 26|"At the end of the double-blind period (week 26), participants were asked: “Are you satisfied with the results of the injection? Answers could be: 1=dissatisfied; 2=slightly satisfied; 3=satisfied; or 4=very satisfied."|Week 26|Intent to treat population|||units on a scale||Standard Deviation|Mean
1433068|NCT00988091|Secondary|Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score. The percent of participants who showed a 20mm or greater improvement in the pain scores at week 26 compared to baseline are reported.|Day 0 (baseline), Week 26|Intent to treat population|||percentage of participants|||Number
1433069|NCT00988091|Secondary|Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26|Adjusted mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm = no pain, stiffness and difficulty; 100 mm = extreme pain, stiffness and difficulty. Change from baseline calculated as: Week 26 minus baseline.|Day 0 (baseline), week 26|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1433070|NCT00988091|Primary|Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26|The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.|Day 0 (baseline) through Week 26|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1433071|NCT00988065|Other Pre-specified|Percentage of Participants With an Adverse Event Suggestive of a Dose-dependent Trend That Also Exceeds a Frequency Threshold Above 5% in Any Treatment Arm (Including Both Serious and Non-serious Adverse Events).|All adverse events from the study were reviewed for potential safety signals. The reported incidences suggestive of a dose-dependent trend and with a frequency threshold above 5% (including both serious and non-serious adverse events) are presented.|From first randomized dose (Day 8) up to 30 days after day of last randomized dose of study medication.|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants|||Number
1433072|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review & determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.~The percentages of subjects who had adjudicated hypersensitivity (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) are presented for each of the 3 treatment arms for each dose."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated, per dose (i.e. who received the corresponding dose of randomized study medication).|||percentage of participants|||Number
1433073|NCT00988065|Secondary|The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine anaphylaxis according to the criteria put forth by the guidelines of the Brighton Collaboration Anaphylaxis Working Group as described by Rüggeberg et al. (Vaccine 2007; 25:5675-5684).~Level 1 represents the highest level of certainty of anaphylaxis and level 3 the lowest level of certainty.~The percentages of subjects who had adjudicated anaphylaxis according to the Rüggeberg Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants|||Number
1433074|NCT00988065|Secondary|The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.|"The Adjudication Committee evaluated each case to determine whether the subject's hypersensitivity sign/symptoms fulfilled the definition of anaphylaxis according to the criteria defined by the Symposium on the Definition and Management of Anaphylaxis as described by Sampson et al. (J Allergy Clin Immunol 2006; 117:391-7).~The percentages of subjects who had adjudicated anaphylaxis according to the Sampson Criteria at any dose (dose 1 [~Day 8], dose 2 [~Day 36], or dose 3 [Day ~78]) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants||95% Confidence Interval|Number
1433075|NCT00988065|Primary|The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.|"Hypersensitivity signs/symptoms were systematically collected for each subject by the investigator. Suspected cases of hypersensitivity signs/symptoms were sent to the independent Adjudication Committee (comprised of anesthesiologists & allergists/immunologists) for blinded review and determination of adjudicated hypersensitivity &/or anaphylaxis based on expert evaluation of all clinical data from the healthy subject.~The percentages of subjects who had adjudicated hypersensitivity at any dose (dose 1/Day 8, dose 2/Day 36, or dose 3/Day 78) were compared between the 3 treatment groups."|Day 8, Day 36, and Day 78 of the study|All-Subjects as treated (i.e., who received at least one dose of randomized study medication).|||percentage of participants||95% Confidence Interval|Number
1433076|NCT00987948|Secondary|Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores|The Z-score represents the number of standard deviations away from the mean, with positive Z-scores representing better neuropsychological performance and negative Z-scores representing poorer neuropsychological performance. Z-scores have been adjusted based on age- and education-matched norms.|Baseline to 24 Weeks|6 of 12 patients who completed the study who had mild to moderate cognitive impairment|||Z-score||Inter-Quartile Range|Median
1433077|NCT00987948|Primary|Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells|Week 24 minus baseline|Baseline to 24 weeks|Outcome measure in the 12 patients who completed the study.|||Log-10 copies/10^6 cells||Inter-Quartile Range|Median
1433107|NCT00987480|Primary|Successful Neutrophil Engraftment||2 years||||Participants|||Count of Participants
1433078|NCT00987935|Secondary|fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib|"fe0-12,ss (fraction excreted in urine between 0 and 12 hours at steady state) for Nintedanib.~The reported value corresponds to the percentage of administered dose."|0 to 4 hours (h), 4 to 12 h, and 12 to 24 h after nintedanib|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||percentage||Geometric Coefficient of Variation|Geometric Mean
1433079|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 glucuronide in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1433080|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the BIBF 1202 in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1433081|NCT00987935|Secondary|Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values)|"Cmax,ss,norm (maximum concentration of the Nintedanib in plasma at steady state, normalised values).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1433082|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 Glucuronide (Metabolite of Nintedanib)|"AUC0-12,ss,norm of BIBF 1202 glucuronide (Metabolite of Nintedanib):~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1433083|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 (Metabolite of Nintedanib)|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of BIBF 1202 (metabolite of Nintedanib).~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1433084|NCT00987935|Secondary|AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of Nintedanib|"AUC0-12,ss,norm (area under the plasma concentration-time curve between 0 and 12 hours at steady state, normalised values) of Nintedanib~Detailed time points of sampling are:~Phase I and selected phase II patients in the Nintedanib arm:~Cycle 1, Day 15 to 16: Immediately prior to swallowing the dose of nintedanib (predose) and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 7 h, 10 h, 12 h and 24 h after drug administration on Day 15; Cycle 2, Day 1: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 1; Cycle 2, Day 15: Immediately prior to swallowing the dose of nintedanib (predose) and 2 h after drug administration on Day 15."|Day1, Day15 and Day 16|Pharmacokinetic set (PKS): The PK set was a subset of the treated set and included all patients who received at least one dose of trial medication and for whom at least one PK observation was available.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
1433085|NCT00987935|Secondary|Overall Survival|Overall survival was defined as the duration from date of randomisation to the date of death.|From randomization until data cut-off (16 July 2014); Up to 171 weeks|Treated set, include only phase II participants|||months||Inter-Quartile Range|Median
1446884|NCT00877929|Secondary|BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks|Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
1433089|NCT00987935|Secondary|Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.|Incidence and worst intensity (severity) of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days)|Treated set|||participants|||Number
1433090|NCT00987935|Secondary|Time to Progression (TTP) in Phase II (Follow-up Analyses)|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until disease progression or data cut-off (16 Jul 2014); Up to 171 weeks|Treated set, Only phase II participants|||months||Inter-Quartile Range|Median
1433091|NCT00987935|Primary|Time to Progression (TTP) in Phase II|TTP according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.0 criteria based on central independent review. TTP RECIST 1.0 was defined as the time from randomisation to disease progression according to RECIST 1.0.|From randomization until data cut-off (28 Sep 2012); Up to 77 weeks|Treated set, only phase II participants.|||months||Inter-Quartile Range|Median
1433092|NCT00987935|Primary|Maximum Tolerated Dose in Phase I|The MTD was defined as the highest dose studied for which the incidence of DLTs was 0/3 or less than 2/6 patients during the first treatment course.|4 weeks|Treated set (Patients from the dose escalation part that were not replaced for MTD determination)|||mg|||Number
1433093|NCT00987831|Post-Hoc|Time to Flare Comparing Patients With (at Baseline) British Isles Lupus Assessment Group Index (BILAG) >/= 17 (Severe Disease) to Those With BILAG < 17 (Moderate Disease Activity).||12 months|Only 40/41 entered patients completed the study by the definition of the endpoint which was flare.|||days to flare||95% Confidence Interval|Median
1433094|NCT00987831|Primary|Time to Flare Comparing Patients With Moderate vs Severe Disease Activity at Baseline|Group A only: patients on immunosuppressive treatments had them withdrawn at baseline. All patients were allowed up to 160 mg depomedrol at baseline which could be repeated within two weeks up to a total of 4 shots maximum or until satisfactory improvement. Time to flare was calculated from baseline. moderate disease at baseline was defined as up to 3 BILAG B (moderate disease) organ scores, no BILAG A (severe disease) score and a SLEDAI </= 10. Severe disease required >3 BILAG B, OR at least one BILAG A OR SLEDAI > 10 or meeting criteria for a severe flare on the SELENA SLEDAI flare index. At baseline 25 patients with moderate disease. 16 patients had severe disease. Note: severe rash with A on BILAG is only SLEDAI=2, explaining some discrepancies in measures|12 months|This prespecified primary outcome was restricted to Group A only. This was an exploratory proof of concept study, not powered for the primary endpoint|||days to flare||95% Confidence Interval|Median
1433095|NCT00987727|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35|Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.|||Number on a scale (score)||Standard Deviation|Mean
1433096|NCT00987727|Primary|Change From Baseline in Global Ocular Staining Score at Day 35|Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).|Baseline, Day 35|Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.|||Number on a scale (score)||Standard Deviation|Mean
1433097|NCT00987623|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week’s wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent|1 week|Analysis conducted per protocol, with exclusions due to major protocol deviations as determined by masked review, discontinuations, and/or missing responses.|||Units on a Scale||Standard Deviation|Mean
1433098|NCT00987558|Primary|Simvastatin AUC0-∞ (AUC From Time Zero to Infinity)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14||||ng.h/mL||Standard Deviation|Mean
1433099|NCT00987558|Primary|Simvastatin AUC0-t|"AUC0-t - area under the plasma concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification~Simvastatin (Reference) ESL + Simvastatin (Test)"|Day 1 and Day 14||||ng.h/mL||Standard Deviation|Mean
1433100|NCT00987558|Primary|Simvastatin Tmax (Time of Occurrence of Cmax)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14||||hours||Standard Deviation|Mean
1433101|NCT00987558|Primary|Simvastatin Cmax (Maximum Plasma Concentration)|Simvastatin (Reference) ESL + Simvastatin (Test)|Day 1 and Day 14||||ng/mL||Standard Deviation|Mean
1433102|NCT00987480|Secondary|Disease-free Survival at 3 Years|"Defined as time from date of transplant to relapse, graft rejection or graft failure, or death.~Primary non-engraftment is diagnosed when the participants fails to achieve an ANC >/= 500/ul at any time in the first 28 days post-transplant.~For participants with MDS or AML, relapse will be analyzed as to type and genetic origin of the MDS/leukemic cells. These will be defined by an increasing number of blasts in the marrow over 5% by the presence of circulating peripheral blasts, or by the presence of blasts in any extramedullary site. Cytogenetic analysis of the marrow and/or peripheral blood will also be obtained for the diagnosis of relapse."|3 years||||percentage of participants|||Number
1433103|NCT00987480|Secondary|Overall Survival at 3 Years|Overall Survival is defined as time from date of transplant to event (death from any cause) or last follow-up.|3 years||||percentage of participants|||Number
1433104|NCT00987480|Primary|The Incidence of Chronic GvHD||2 years||||Participants|||Count of Participants
1433105|NCT00987480|Primary|The Incidence of Acute GvHD||100 days||||percentage of participants|||Number
1433109|NCT00987467|Primary|Ocular Symptoms and Signs Total Composite Score|Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) evaluated on a 4 point scale of 0-3, with a minimum symptom score of 0- maximum 15, and sign score minimum 0- maximum 18. These scores are combined to yeild a total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of Atopic Keratoconjunctivitis (AKC). The composite score is reported.|Baseline and 8 weeks||||units on a scale||Full Range|Mean
1433110|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||meters||Standard Deviation|Mean
1433111|NCT00987415|Secondary|Change in Quality of Life (KCCQ)|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 24 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||units on a scale||Standard Deviation|Mean
1433112|NCT00987415|Secondary|Change in Submaximal Exercise Capacity (6-MWT)|6-Minute Walk Test|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||meters||Standard Deviation|Mean
1433113|NCT00987415|Secondary|Change in Quality of Life (KCCQ).|Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 12 weeks|Participants analyzed included those patients who had complete data for this endpoint.|||units on a scale||Standard Deviation|Mean
1433114|NCT00987415|Primary|A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.|CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved|24 Weeks||||participants|||Number
1433115|NCT00987402|Primary|Surgical Site Infection|255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33).|30 days post-operatively||||Participants|||Number
1433116|NCT00987402|Secondary|Cost of Hand Preparation Agent|Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms.|30 days|||||||
1433117|NCT00987337|Secondary|Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin||Week 0 (pre-dose), Week 2, 4, 8, 12, 16, 20, 24, 48 (only for those participants who received treatment till Week 48) post-dose|Data could not be summarized due to sparse sampling time points adopted for this study.||||||
1433118|NCT00987337|Secondary|Number of Participants With Laboratory Test Abnormalities by Severity|Number of participants with laboratory abnormalities by Division of Auto Immune Disease Syndrome (DAIDS) grade of 4; 3 or 4; 2, 3 or 4 was summarized. Abnormal laboratory values refers to a DAIDS grade greater than 0, where grade 1= mild, grade 2= moderate, grade 3= severe and grade 4 = potentially life-threatening.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1433119|NCT00987337|Secondary|Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||participants|||Number
1433120|NCT00987337|Secondary|Number of Participants Who Discontinued Study Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||participants|||Number
1433121|NCT00987337|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 72 that were absent before treatment or that worsened relative to pretreatment state. All causality AEs included SAEs as well as non-serious AEs, without regard to relationship to the study drug, which occurred during the trial. Treatment-related were events considered related to study drug by the investigator. Number of participants with treatment related TEAEs and all causality TEAEs were summarized.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||participants|||Number
1433622|NCT00984061|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration||||ng/mL||Standard Deviation|Mean
1433122|NCT00987337|Secondary|Number of Adverse Events (AEs) by Severity (All Causality)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were graded as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). The most severe grade was used in case of multiple occurrences of the same event.|Baseline up to Week 72|Safety population included all randomized participants who took at least 1 dose of study drug analyzed as treated.|||adverse events|||Number
1433123|NCT00987337|Secondary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24|Plasma HCV RNA levels were measured using the Roche COBAS TaqMan assay (limit of detection: 15 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4, 12, 24|ITT population included all randomized participants who took at least 1 dose of study drug. LOCF method was used for imputing missing values for participants who did not discontinue from study. Final value was imputed as baseline for participants who discontinued before the time point of interest.|||log10 IU/mL||Standard Deviation|Mean
1433124|NCT00987337|Secondary|Percentage of Participants With Relapsed Response|A participant was considered to have relapsed response if the plasma HCV RNA levels were undetectable at end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) but detectable (>=15 IU/mL) during the off-treatment follow-up period up to Week 72. Overall percentage of participants with relapsed response was summarized.|Week 24 or Week 48 up to Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Participant with all the HCV RNA values missing during follow-up was imputed as having relapsed.|||percentage of participants|||Number
1433125|NCT00987337|Secondary|Percentage of Participants With Breakthrough Viremia|A participant was considered to have breakthrough viremia if there was a >2 log10 increase from nadir in HCV RNA concentration while on treatment or HCV RNA that became undetectable with treatment but then became persistently detectable (2 or more consecutive viral RNA measurements >1000 IU/mL) again during treatment. Overall percentage of participants with breakthrough viremia was summarized.|Baseline up to Week 48|ITT population included all randomized participants who took at least 1 dose of study drug.|||percentage of participants|||Number
1433126|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)|SVR24 was summarized only for those participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24 and all participants who received placebo for 48 weeks. A participant was considered to have achieved SVR24 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 for filibuvir participants who ended therapy at Week 24 and Week 48 for participants who received placebo) and 24 weeks following the completion of therapy (Week 48 for filibuvir participants who ended therapy at Week 24; Week 72 for placebo participants who ended therapy at Week 48).|24 weeks after completion of therapy (Week 48 or 72)|ITT population.N (number of participants analyzed)=evaluable participants for the measure. Missing HCV RNA value at EOT, all follow-up visits/at specified time point, all subsequent visits was considered not to have undetectable HCV RNA.Missing HCV RNA value at 24 weeks after EOT was imputed using value of subsequent follow-up visit, if available.|||percentage of participants|||Number
1433127|NCT00987337|Secondary|Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)|A participant was considered to have achieved SVR12 if the plasma HCV RNA levels were <15 IU/mL at both the end of treatment (Week 24 or 48, depending on the time of therapy discontinuation based on HCV RNA levels during therapy) and 12 weeks following the completion of therapy (Week 36 for participants who ended therapy at Week 24; Week 60 for participants who ended therapy at Week 48). Overall percentage of participants with SVR12 was summarized.|12 weeks after completion of therapy (Week 36 or 60)|ITT population. Participant with missing HCV RNA values at end of treatment and all follow-up visits or at the specified time point and all subsequent visits was considered not to have undetectable HCV RNA. Missing HCV RNA value at 12 weeks following completion of therapy was imputed using value of subsequent follow-up visit, if available.|||percentage of participants|||Number
1433128|NCT00987337|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48|Percentage of participants with undetectable HCV RNA at Week 4 (rapid viral response [RVR]), Week 12 (early viral response [EVR]), Week 24 and Week 48 were summarized. Undetectable HCV RNA was defined as plasma HCV RNA levels <15 IU/mL.|Week 4, 12, 24, 48|ITT population included all randomized participants who took at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values for participants who did not discontinue from study. Participants who discontinued early from the study were considered not to have undetectable HCV RNA.|||percentage of participants|||Number
1433129|NCT00987337|Primary|Percentage of Participants With Sustained Viral Response (SVR) at Week 72|For participants who received filibuvir, had undetectable HCV RNA from Week 4 through 24 and discontinued therapy at Week 24, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 24 (End of Treatment [EOT]) and Week 72, regardless of the HCV RNA levels between Week 24 and 72. For participants who received filibuvir, had detectable HCV RNA at Week 4 or later and discontinued therapy at Week 48 or who received placebo, SVR was defined as undetectable plasma HCV RNA levels (<15 IU/mL) at both Week 48 (EOT) and Week 72, regardless of the HCV RNA levels between Week 48 and 72.|Week 72|ITT population included all randomized participants who took at least 1 dose of study drug. If a participant had a missing value at Week 72, participant was considered a failure; if a participant had achieved SVR but died or discontinued within same time period, the participant was considered a success.|||percentage of participants|||Number
1433130|NCT00986999|Secondary|Change in hsCRP||3 months|||||||
1433131|NCT00986999|Secondary|Change in Total, HDL and LDL Cholesterol and Triglyceride Levels||3 months|||||||
1433132|NCT00986999|Secondary|Change in Glucose Homeostasis and Insulin Resistance as Assessed by Oral Glucose Tolerance Testing||3 months|||||||
1433140|NCT00986973|Secondary|Delis-Kaplan Executive Function System Verbal Fluency Subtest (D-KEFS)|The Delis–Kaplan Executive Function System (D-KEFS) is a neuropsychological test is used to measure a variety of verbal and nonverbal executive functions for both children and adults. Among the 9 subtests is the Verbal Fluency Test which measures letter fluency, category fluency, and category switching. Verbal Fluency Test. This subtest requires an individual to randomly generate words based upon given parameters (ex., as words beginning with the letter F) and the believed areas of executive function assessed are cognitive flexibility, response inhibition, and verbal fluency. Raw scores are calculated based on the number of correct answers, which are then converted to scaled scores with a mean of 10 and standard deviation of 3. Higher scaled score represents a higher level of executive verbal and nonverbal function.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all assessments.|||units on a scale||Inter-Quartile Range|Median
1433141|NCT00986973|Secondary|Wechsler Adult Intelligence Scale (WAIS-IV)-Digit Span|The Wechsler Adult Intelligence Scale (WAIS) is a test designed to measure intelligence in adults and older adolescents. It is composed of 10 core subtests and five supplemental subtests, with the 10 core subtests comprising the Full Scale intelligence quotient (IQ). Contained within the WAIS is an assessment of digit-coding which consists of nine digit-symbol pairs followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured, with a higher score representative of a higher performance component of IQ/intelligence.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all WAIS-IV assessments.|||Number of correct symbols||Inter-Quartile Range|Median
1433142|NCT00986973|Secondary|Symbol-Digit Modalities Test (SMTD)|The symbol-digit modalities test (SDMT) was developed to identify individuals with neurological impairment. The SDMT requires individuals to identify nine different symbols corresponding to the numbers 1 through 9, and to practice writing the correct number under the corresponding symbol. Then they manually fill the blank space under each symbol with the corresponding number. A second oral administration is then completed. The participant is given a blank copy of the test and asked to state the correct number for each corresponding symbol. The participant is given 90 s to complete each of these administrations. A written and oral score is calculated by totaling the number of correct answers for each section. The score is the number of correctly coded items from 0-110 in 90 seconds, with a higher score representing less neurological impairment with respect to attention, scanning abilities and motor skills. The total raw score was used for purposes of this study.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all SMTD assessments.|||units on a scale||Inter-Quartile Range|Median
1433143|NCT00986973|Secondary|Paced Auditory Serial Addition Task (PASAT)|The Adapted Paced Auditory Serial Addition Task (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. For Rates #1 and #2, single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for PASAT is the total number of correct answers (out of 60, for a total possible score ranging from 0-60 with higher score preferred as it indicates higher auditory processing speed) for each trial. All scores are expressed as “z-scores” which are generated based on norms for 101 healthy adults, with separate norms for <12 years of education versus >12years of education. Using a reference population as a basis of comparison, the “z-score” is the number of standard deviations the score is above (positive) or below (negative) the mean of the reference population (zero). Possible z-scores lie on a continuous scale.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all PASATassessments.|||units on a scale||Inter-Quartile Range|Median
1433144|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Delayed Recall|The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to “T-scores” by means of age-based tables provided in test manual (T-scores can go from 0 – 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.|||units on a scale||Inter-Quartile Range|Median
1433145|NCT00986973|Secondary|Hopkins Verbal Learning Test (HVLT) Total Recall|The Hopkins Verbal Learning Test-Revised (HVLT) is a neuropsychological test designed to assess verbal memory. The test consists of 12 nouns (targets) with four words drawn from each of three semantic categories. Raw scores are derived for Total Recall (across three learning trials), Delayed Recall (after 20-25 minute delay), Retention (% retained), and a Recognition Discrimination Index (true positives minus false positives). The maximum total for each recall trial (Learning Trials 1 to 3, Delayed Recall Trial 4) is 12. Raw scores are converted to “T-scores” by means of age-based tables provided in test manual (T-scores can go from 0 – 100, with higher scores correlating with higher verbal memory function). Median HVLT Total Recall and HVLT Delayed Recall T-scores at baseline and 4 months after Sapropterin therapy were compared.|Measures were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 Subject was withdrawn from the study due to poor compliance with KUVAN therapy and did not complete all HVLT assessments.|||units on a scale||Inter-Quartile Range|Median
1433194|NCT00986427|Secondary|Change From Baseline in Quality of Life (QOL) Related to Nail Disease|"Change from baseline in quality of life as measured at week 24 by the subject satisfaction Questionnaire question: Overall, how satisfied are you with your nails? Responses ranged from 1 (very satisfied) to 5 (very unsatisfied). A negative number changed from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24||||scores on a scale||Standard Deviation|Mean
1433146|NCT00986973|Primary|Plasma Phenylalanine Level (mg/dl)|Plasma phenylalanine level (mg/dl) served as the primary means of evaluating brain glucose metabolism before and after sapropterin (KUVAN) therapy. Blood tests for phenylalanine levels (Phe) were collected before and 4 months after sapropterin (KUVAN) therapy. All subjects received KUVAN at a dose of 20/mg/kg/day for four months. The goal was to estimate the change in blood glucose metabolism after treatment with Sapropterin (if any), with the hypothesis that treatment would decrease plasma Phe levels.|Measurements were obtained at the beginning and conclusion of each study period (baseline and 4 months)|1 subject was withdrawn from the study due to poor compliance with KUVAN therapy.|||mg/dl||Standard Deviation|Mean
1433147|NCT00986960|Secondary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. in RRMS on Anterior Optic Pathway Pathology, as Measured by OCT and LCLA in Patients With RRMS.||1 year|||||||
1433148|NCT00986960|Primary|To Define the Effect of add-on Pulsed IM ACTH vs. Placebo to IFNβ-1a I.M. on a Voxel-wise MTR Dynamic Mapping of the Lesions and NABT in Patients With RRMS|None. Study did not initiate recruitment or data collection.|1 year|||||||
1433149|NCT00986947|Secondary|Decrease in Panel Reactive Antibody||4 months|Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.||||||
1433150|NCT00986947|Primary|Time to Kidney Transplantation||4 months|Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.||||||
1433151|NCT00986921|Secondary|Moderate or Severe Pain Overnight|Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)|Overnight|All participants are included|||percentage of participants|||Number
1433152|NCT00986921|Secondary|Assessment of Ease of Procedure by Operator|"The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult."|It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.|"All participants with a completed abortion procedure were rated by the operator as to ease of completing the procedure. The number of women in each group having an abortion procedure rated easy or very easy is tabulated"|||percentage of participants|||Number
1433153|NCT00986921|Primary|Time for Completion of Procedure|Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)|Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.|Of the 25 women enrolled in the osmotic dilator group, all had osmotic dilators insertion. One woman aborted spontaneously before the surgical abortion; therefore she did not have an abortion procedure and time could not be obtained. she did contribute information about her experience to that point.|||Minutes||95% Confidence Interval|Mean
1433154|NCT00986856|Secondary|The Actual Change in Total Severity Score From Baseline to End of Treatment (LOCF).|Total Severity Score is the sum of scores for the following 5 signs: Pustules/infected bullae, erythema, infiltration/induration, erosions and crusting. Each sign is assessed using a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe involvement. Minimum Total Severity score is 0, maximum score is 15.|EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)|||Units on a scale||Standard Error|Mean
1433155|NCT00986856|Secondary|Number of Patients With Bacteriological Success at EOT||EOT: Visit at day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline|||Participants|||Number
1433156|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation|||Participants|||Number
1433157|NCT00986856|Secondary|Number of Patients With Bacteriological Success at Visit 2||Visit 2: Day 4|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline|||Participants|||Number
1433158|NCT00986856|Secondary|Number of Patients With Clinical Success at EOT||EOT: Visit at day 25|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)|||Participants|||Number
1433159|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 3||Visit 3: Day 11|The analysis population were those patients who had a visit 3 observation|||Participants|||Number
1433160|NCT00986856|Secondary|Number of Patients With Clinical Success at Visit 2||Visit 2: Day 4|The full analysis set consists of 56 patients, 40 patients in the Fucidin® cream 20 mg/g group and 16 patients in the Fucidin® cream vehicle group (2 patients excluded because of lack of efficacy data)|||Participants|||Number
1433161|NCT00986856|Primary|Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT).||EOT: Visit at Day 25|The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline|||Participants|||Number
1433162|NCT00986674|Secondary|Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients who have response data. 3 patients on arm I and 1 patient on arm III had unknown/missing tumor response and were excluded from the analysis|||percentage of participants||95% Confidence Interval|Number
1433163|NCT00986674|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients|||months||95% Confidence Interval|Median
1433164|NCT00986674|Primary|Progression Free Survival|"Progression free survival is defined as time from registration to disease progression or death from any cause, whichever occurred earlier. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .~All eligible and treated patients were included in the analysis."|Tumor measurements are repeated every 6 weeks while on treatment. After off treatment, assessed every 3 months if patient is < 2 years from study entry and every 6 months in year 3|eligible and treated patients|||months||95% Confidence Interval|Median
1433165|NCT00986583|Secondary|Fasciculation|The fasciculation ranges from 0 to 3: 0 none; 1 small movements around eyes and fingers; 2 moderate movements in face, neck, fingers, and trunk; and 3 vigorous movements in trunk and extremities.|postoperative||||participants|||Number
1433166|NCT00986583|Secondary|Duration of Succinylcholine Block|Time required to reach maximum block by succinylcholine after succinylcholine administration.|intraoperative: from succinylcholine administration||||minute||Inter-Quartile Range|Median
1433167|NCT00986583|Secondary|Change in Plasma Creatine Phosphokinase (CK) Concentration From 2 to 24 Hours Postoperatively|Change in plasma creatine phosphokinase (CK) concentration from 2 to 24 hours postoperatively|2 and 24 hours postoperatively|Two patients in the nonstatin group had missing CK value at 2 hour|||units/l||Inter-Quartile Range|Median
1433168|NCT00986583|Secondary|Serum Potassium Concentration||At 5 and 20 min after succinylcholine|Two patients in non-statin group had missing value at 20 minute.|||mEq/l||Inter-Quartile Range|Median
1433169|NCT00986583|Secondary|Muscle Pain|"verbal rating scale score and the pain score both at 2 and 24 hours postoperatively.~The verbal rating scale score ranges from 0 (no pain) to 100 (worst pain imaginable).~The pain score ranges from 0 to 3: 0 none; 1 muscle stiffness or pain in the nape of the neck, shoulders, and chest; 2 muscle stiffness and pain requiring analgesia; and 3 incapacitating generalized muscle stiffness or pain."|2 and 24 hours postoperatively||||participants|||Number
1433170|NCT00986583|Primary|Plasma Myoglobin Concentration||induction, 5 minutes after administration, 20 minutes and 24 hours post operatively||||ug/l||Inter-Quartile Range|Median
1433171|NCT00986570|Primary|Treatment Success|Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment. The wrinkles will be classified according to the following: absence, mild, moderate, severe.|Baseline (pre-treatment) and Visit 3 (Day 15)||||% of participants||95% Confidence Interval|Number
1433172|NCT00986544|Secondary|Number of Participants With Postoperative Complications||1 month|Intention to treat analysis|||participants|||Number
1433173|NCT00986544|Primary|Number of Participants With Subhepatic Collection at Ultrasonographic Examination|An abdominal ultrasonography was routinely performed on the first postoperative day with the aim to detect any fluid collection. If present, the volume in ml of subhepatic collection was calculated.|first postoperative day|An intention to treat (ITT) analysis was performed.|||Participants|||Number
1433174|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Positive Score.|Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.||||Units on a scale||Standard Error|Least Squares Mean
1433175|NCT00986479|Secondary|Visual Analogue Scale (VAS) Anxious Score.|"The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between “extreme sad” (0-mm) and “extreme happy (100-mm), with a median “normal” point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433176|NCT00986479|Secondary|Young Mania Rating Scale (YMRS) Score.|Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433177|NCT00986479|Secondary|Beck Depression Inventory (BDI) Score.|Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433178|NCT00986479|Secondary|Brief Psychiatric Rating Scale (BPRS) Score.|"The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126.~18 is considered to be the best outcome, 126 the worst."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433208|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Fentanyl|Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 22 participants with previous transdermal fentanyl treatment.|||Ratio|||Number
1433179|NCT00986479|Secondary|Clinician-Administered Dissociative States Scale (CADSS) Score.|Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433180|NCT00986479|Secondary|Visual Analogue Scale (VAS) Depressed Score|"The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between “extreme sad” (0-mm) and “extreme happy (100-mm), with a median “normal” point."|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.|||Scores on a scale||Standard Error|Least Squares Mean
1433181|NCT00986479|Secondary|Hamilton Depression Rating Scale-17 Item (HDRS) Total Score|Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433182|NCT00986479|Secondary|Hamilton Anxiety Rating Scale (HAM-A) Total Score.|Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.|60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.||||Units on a scale||Standard Error|Least Squares Mean
1433183|NCT00986479|Secondary|Scale for Suicide Ideation (SSI) Total Score.|Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433184|NCT00986479|Secondary|The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).|Response defined as a >= 50% reduction from baseline in MADRS total score. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Participants|||Number
1433185|NCT00986479|Secondary|The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).|Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score <10. MADRS is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Participants|||Number
1433186|NCT00986479|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.|60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.|ITT population including all randomized patients who were given study treatment.|||Units on a scale||Standard Error|Least Squares Mean
1433187|NCT00986453|Secondary|Dissection Performance|Amount of tissue (g) removed over time (min)|Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||g/min|Participants|Standard Deviation|Mean
1433188|NCT00986453|Secondary|Amount of Tissue Removed||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||g|Participants|Standard Deviation|Mean
1433189|NCT00986453|Secondary|Operative Time||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||minutes|Participants|Standard Deviation|Mean
1433190|NCT00986453|Secondary|Estimated Blood Loss||Intraoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||mL|Participants|Standard Deviation|Mean
1433191|NCT00986453|Primary|Postoperative Pain|"The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.~Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days."|0 to 10 days postoperative|Two subjects were removed from the analysis of secondary variables owing to protocol deviations.|||units on a scale|Participants|Standard Deviation|Mean
1433192|NCT00986427|Secondary|Number of Subjects Achieving Improvement in the Physician's Global Improvement Assessment (PGIA)|Number of subjects achieving improvement in the PGIA. The investigator assessed the two target fingernails with a rating of Excellent, Good, Fair, No Improvement or Worse based on the comparison between the nails at the current visit and high-resolution photographs of the nails taken at baseline. An improvement was a score of Excellent/Good/Fair vs. No Improvement/Worse.|Week 24||||participants|||Number
1433195|NCT00986427|Primary|Change From Baseline in the Physician's Global Assessment (PGA) of Target Fingernails #1 and #2|"Change from baseline in the Physician's Global Assessment (PGA) of target fingernails #1 and #2 as measured at week 24.~The PGA is a static evaluation/measure of the severity of brittle nails signs in target fingernails #1 and #2 (the 2 nails with the most severe signs of brittleness). Evaluated sings were the degree of lamellar onychoschizia, ridging, longtitudinal splitting, fragility/breakage and thickness. The PGA was scored on a 6 point scale from 0 to 5, in which 0 = none, 1 = mild, 2 = mild to moderate, 3 = moderate, 4 = moderate to severe, 5 = severe. A negative number change from baseline (decrease in grade score) indicates improvement and a positive change (increase in grade score) indicates worsening."|Baseline, week 24||||scores on a scale||Standard Deviation|Mean
1433196|NCT00986401|Secondary|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®|Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR® alone and in combination with Glucophage®. Plasma is the fluid portion of the blood in which the cells are suspended.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1433197|NCT00986401|Primary|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®|Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.|34 Days|Intent-to-treat, which includes all patients who started the study (randomized). One patient was not included in the analysis due to early discontinuation.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1433198|NCT00986362|Primary|Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).|Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.|Beginning of vitrectomy or after application of suction|Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups|||percentage of eyes|Participants||Number
1433199|NCT00986349|Other Pre-specified|Fasting Plasma Glucose Over Time for All Subjects||Baseline to 12 months post Device Explant|Subjects with a Successful Device Implant Procedure|||mmol/L||Full Range|Median
1433200|NCT00986349|Secondary|Total Weight Change (kg) at Week 52 Compared to Baseline Weight||Baseline to 52 weeks||||kg||Standard Deviation|Mean
1433201|NCT00986349|Primary|Change in Anti-diabetes Medications|Medications were classified as “increased” if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as “decreased” if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as “not assessable.”|Baseline to 52 weeks||||Participants|||Count of Participants
1433202|NCT00986349|Primary|Assessment of Glycemic Control (HbA1c) Over Time|HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12|Baseline to 12 Months with device implanted|20 subjects with a successfully implanted device were analyzed at Baseline. 1 subject removed at day 75 due to non-compliance with attending required visits. 1 subject removed at 175 due to device rotation, 2 subjects removed at day 203 and 313 due to abdominal pain AE|||HbA1c %||Full Range|Median
1433203|NCT00986258|Secondary|painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433204|NCT00986258|Secondary|painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment|"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433205|NCT00986258|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433206|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone|Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 8 participants with previous hydromorphone treatment.|||Ratio|||Number
1433207|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Morphine|Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine.|Baseline; End of Week 6 (6 Weeks)|Intent to treat (ITT). 14 participants with previous morphine treatment.|||Ratio|||Number
1435998|NCT00965185|Secondary|Immune Function|12 month change in CD4 T-lymphocytes|Measured at baseline and 1 year|All available data were used; data were not available for one subject who completed the study.|||cells per microliter||95% Confidence Interval|Mean
1433209|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 24 participants with previous buprenorphine treatment.|||Ratio|||Number
1433210|NCT00986258|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 35 participants with previous oxycodone treatment.|||Ratio|||Number
1433211|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.~The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433212|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|End of Week 6|"Intention to treat (ITT).~For the sub-scores Overall Score and Pressing Pain there were only 60 participants with data available at Visit 6."|||units on a scale||Standard Deviation|Mean
1433213|NCT00986258|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score|"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)."|Baseline|"Intention to treat (ITT).~For the sub-scores Overall Score and Pressing Pain there were only 69 participants with data available at baseline."|||units on a scale||Standard Deviation|Mean
1433214|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 Weeks)|"Intention to Treat (ITT).~For the sub-scores Role Emotional and Role Physical, there were only 91 participants with data available for the change of these sub-scores from baseline to visit 12."|||units on a scale||Standard Deviation|Mean
1433215|NCT00986258|Secondary|Change in the Health Survey Scores Form (SF-36)|The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 Weeks)|"Intention to treat (ITT).~For the sub-scores Role Emotional and Role Physical there were 98 participants, for sub-scores Physical Functioning, Vitality and Mental Health there were 99 participants, for sub-score General Health there were 100 participants with data available for the change of these sub-scores from baseline to visit 6."|||units on a scale||Standard Deviation|Mean
1433216|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT)|||participants|||Number
1433217|NCT00986258|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT)|||participants|||Number
1433218|NCT00986258|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433235|NCT00986245|Primary|Patient Preference|Patient preference between once-daily and twice-daily regimen|After 16 weeks or at last visit for early completion|"Primary outcome measure was the preference of the subjects between once-daily versus twice-daily of RPR at the completion or at early completion after crossover.~61 of participants completing period with study intervention."|||participants|||Number
1433219|NCT00986258|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
1433220|NCT00986258|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat|||units on a scale||Standard Deviation|Mean
1433221|NCT00986258|Primary|Number of Participants That Responded to Treatment|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment as with their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).|||participants|||Number
1433222|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Dyskinesia|Patients who have Global Impression for Improvement to Severity of Dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia severity.|||participants|||Number
1433223|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Dyskinesia|Patients who have global impression for improvement to duration of dyskinesia compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia duration.|||participants|||Number
1433224|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation|Patients who have global impression for improvement to severity of motor fluctuation compared|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation severity.|||participants|||Number
1433225|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation|Patients who have global impression for improvement to duration of motor fluctuation|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation duration.|||participants|||Number
1433226|NCT00986245|Secondary|Patients Who Have Global Impression for Improvement|Patients who have global impression for improvement for each dosing.|After 8 weeks in each arm or at last visit for early completion|The number of patient who completed the study and answered the questionnaire for global impression.|||participants|||Number
1433227|NCT00986245|Secondary|Adverse Events|Patients who have adverse events|After 8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||participants|||Number
1433228|NCT00986245|Secondary|Compliance|Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||percentage of used medication||Standard Deviation|Mean
1433229|NCT00986245|Secondary|Epworth Sleep Scale|"Epworth sleep scale after 8 weeks in each arm or at last visit for early completion.~Range: 0~24 Higher values represent worse daytime-sleepiness."|8 weeks in each arm or at last visit for early completion|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
1433230|NCT00986245|Secondary|Early Morning Off Symptoms|"Sleep questionnaire 3 for early morning off symptoms Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
1433231|NCT00986245|Secondary|Nocturnal Off-symptoms|"Sleep questionnaire 2 for Nocturnal off-symptoms Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
1433232|NCT00986245|Secondary|Overall Quality of Sleep|"Sleep questionnaire 1 for Overall quality of sleep Visual analogue scale: 0~10 Higher values represent worse overall sleep quality."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
1433233|NCT00986245|Secondary|Hoehn and Yahr Stage|Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0~5 Higher values represent more severe parkinsonism|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||Scores on a scale||Standard Deviation|Mean
1433234|NCT00986245|Secondary|Unified Parkinson's Disease Rating Scale, Part 3|"Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion.~UPDRS part 3 is motor scale for parkinson's disease. Range: 0~108 Higher values represent more severe motor symptoms of parkinsonism."|8 weeks for each arm or at last visit|Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or Twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.|||units on a scale||Standard Deviation|Mean
1433236|NCT00986232|Secondary|Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1433237|NCT00986232|Secondary|Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1433238|NCT00986232|Secondary|Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1433239|NCT00986232|Secondary|Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)|Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mcg/mL||95% Confidence Interval|Geometric Mean
1433240|NCT00986232|Secondary|Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)|Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination Visit 1 or Visit 2|All participants with follow-up for safety were included in the analysis.|||Participants|||Number
1433241|NCT00986232|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
1433242|NCT00986232|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL|Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
1433243|NCT00986232|Secondary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL|Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
1433244|NCT00986232|Primary|Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units|Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units|6 weeks postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.|||Participants|||Number
1433245|NCT00986180|Secondary|Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain|50% response means >= 50% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Hours||95% Confidence Interval|Median
1433246|NCT00986180|Secondary|Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain|30% response means >= 30% reduction from baseline in low back pain intensity score.|Day 0 and Day 10/last visit|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Hours||95% Confidence Interval|Median
1433247|NCT00986180|Secondary|Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event|Number of subjects that reported pruritus as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
1433248|NCT00986180|Secondary|Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event|Number of subjects that reported constipation as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
1433249|NCT00986180|Secondary|Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event|Number of subjects that reported vomiting as a treatment emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
1433250|NCT00986180|Secondary|Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event|Number of subjects that reported nausea as a treatment-emergent adverse event during the study.|Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
1433251|NCT00986180|Secondary|Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation||Day 0 and Day 10/last visit|Safety Population: all randomized subjects who take at least 1 dose of study drug.|||Participants|||Number
1433252|NCT00986180|Secondary|Incidence of 50% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Participants|||Number
1433253|NCT00986180|Secondary|Incidence of 30% Responders Without Nausea or Vomiting at Day 5|Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Participants|||Number
1433254|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population with subject's satisfaction assessment at end of the study.|||Units on a Scale||Standard Deviation|Mean
1433255|NCT00986180|Secondary|Satisfaction With Treatment at End of Study|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 10/last visit|Intent-To-Treat Population.|||Units on a Scale|||Number
1433256|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population with subject's satisfaction assessment on Day 5.|||Units on a Scale||Standard Deviation|Mean
1433257|NCT00986180|Secondary|Satisfaction With Treatment at Day 5|The subject’s satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied).|Day 0 and Day 5|Intent-To-Treat Population.|||Units on a Scale|||Number
1433258|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population with CGIC assessment.|||Units on a Scale||Standard Deviation|Mean
1433259|NCT00986180|Secondary|Clinician Global Impression of Change at End of Study|Clinician Global Impression of Change (CGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.|||Units on a Scale|||Number
1433260|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/lst visit|Intent-To-Treat Population with PGIC assessment.|||Units on a Scale||Standard Deviation|Mean
1433261|NCT00986180|Secondary|Patient Global Impression of Change at End of Study|Patient Global Impression of Change (PGIC) assesses the subject’s global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).|Day 0 and Day 10/last visit|Intent-To-Treat Population.|||Units on a Scale|||Number
1433262|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 10|Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433263|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Total Score Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433264|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433265|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||score of scale||Standard Deviation|Mean
1436167|NCT00963872|Secondary|Neutrophil Engraftment|Achieving 500 neutrophils/uL by day 42.|Day 42|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1433266|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or “pins and needles” and numbness.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433267|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or “pins and needles” and numbness.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433268|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433269|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing.|Day 0 and Day 5|Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433270|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 10|Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements.|||Units on a Scale||Standard Deviation|Mean
1433271|NCT00986180|Secondary|SF-MPQ-2 – Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5|Short-Form McGill Pain Questionnaire – 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender.|Day 0 and Day 5|Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement|||Units on a Scale||Standard Deviation|Mean
1433272|NCT00986180|Secondary|Total Pain Relief (TOTPAR) for Low Back Pain – Summary Statistics at 5 Days|Pain Relief – 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
1433273|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
1433274|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 5 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days.|Day 0 and Day 5|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
1433275|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
1433276|NCT00986180|Secondary|SPID for Index Leg Pain – Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
1433277|NCT00986180|Secondary|SPID for Low Back Pain – Summary Statistics at 10 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days.|Day 0 and Day 10|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a scale||Standard Error|Least Squares Mean
1433278|NCT00986180|Secondary|SPID for Low Back Pain – Summary Statistics at 3 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days.|Day 0 and Day 3|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a scale||Standard Error|Least Squares Mean
1433279|NCT00986180|Secondary|Sum of Pain Intensity Difference (SPID) for Low Back Pain – Summary Statistics at 2 Days (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days.|Day 0 and Day 2|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a Scale||Standard Error|Least Squares Mean
1433280|NCT00986180|Primary|Sum of Pain Intensity Difference (SPID) for Low Back Pain – Summary Statistics at 120 Hours (With Imputation)|Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours.|0 hour (prior to first dose) and 120 hours|Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS).|||Units on a scale||Standard Error|Least Squares Mean
1433281|NCT00986154|Secondary|Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment|Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.|12 months from time of randomization|Safety Analysis Set|||participants with an event|||Number
1433282|NCT00986154|Secondary|The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality||12 months from time of randomization|mITT Analysis set|||number of participants with event|||Number
1433283|NCT00986154|Primary|Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE|"Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.~Overall Study Period defined as The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."|12 months from time of randomization|(mITT) modified Intent To Treat Analysis Set|||number or participants with an event|||Number
1433284|NCT00986102|Secondary|Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1433285|NCT00986102|Secondary|Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)||Within 28 days after EOT (Day 5 or Day 7 or Day 14)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1433286|NCT00986102|Secondary|Medical Resource Utilization|Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.|From Baseline (Day -1) upto the duration of hospital stay of a participant|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Days||Full Range|Median
1433287|NCT00986102|Secondary|Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit||Day 5 or Day 7 or Day 14|Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication.|||Participants|||Number
1433288|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit||End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1433289|NCT00986102|Secondary|Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)||Day 5 or Day 7 or Day 14|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1433304|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I|Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2|||ng/mL||Standard Deviation|Mean
1433290|NCT00986102|Primary|Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score|APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.|Baseline (Day -1)|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1433291|NCT00986102|Primary|Duration of Antibiotic Therapy|Duration of doripenem and duration of doripenem plus oral antibiotics therapy|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Days||Standard Deviation|Mean
1433292|NCT00986102|Primary|Number of Participants With Different Mode of Usage of Doripenem||5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1433293|NCT00986102|Primary|Number of Participants With the Usage of Doripenem as Per the Approved Indication|Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization|5 to 14 days|Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.|||Participants|||Number
1433294|NCT00985985|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Cardiovascular AEs and Who Discontinued Due to AEs|All AEs and SAEs were reviewed and reported by investigator. AEs were graded on a 3-point scale as Mild, Moderate and Severe.|Weekly assessments from first treatment dose up to 15 days after last treatment dose|Safety Population of this study consists of all randomized participants who have had study medication for at least once.|||Participants|||Number
1433295|NCT00985985|Secondary|Mean Change From Baseline in Body Weight at Week 6, Week 12 and Week 24/ Premature Termination.|Change in body weight was analyzed at Weeks 6, 12, and 24.|Baseline, Week 6, 12 and Week 24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point i.e. Week 6, Week 12 and Week 24. Missing values were not imputed.|||kilogram (kg)||Standard Deviation|Mean
1433296|NCT00985985|Secondary|Mean Daily Dose at Visit 4, 5, 6, 7 and 10|Mean daily dose of lozenges was calculated as number of lozenges taken at each visit divided by days since the last visit.|Weeks 1-2, 3-4, 5-6, 7-12 and 13-24|Analysis was carried out per FAS population, which consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the population analyzed (n) for this outcome measure at each time point. Missing values were not imputed.|||Number of lozenges||Standard Deviation|Mean
1433297|NCT00985985|Secondary|Mean Score of Relief of Craving/ Total Withdrawal Symptoms|The evaluation of withdrawal and craving symptoms was carried out every day with the Minnesota Nicotine Withdrawal scale (MNWS). The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated on a 5 grade scale with scores ranging from 0 (best score) to 4 (worst score) i.e. none (score=0), slight (score=1), mild (score=2), moderate (score=3), and severe (score=4). For each symptom at each week, the average score was calculated as the average of the daily scores during that week. The total score was calculated as the sum of the 9 symptoms.|Weekly assessment at Week 1, 2, 3, 4, 5 and Week 6|Analysis was carried out per FAS population, which consisted of all randomized subjects who have had study medication for at least once with assessment data post-dosing. Due to drop outs, there was difference in the number of participants analyzed (n) for this outcome measure. Missing values were not imputed.|||Score on a scale||Standard Deviation|Mean
1433298|NCT00985985|Secondary|Proportion of Participants With Seven Day Point Prevalence Abstinence|Seven day point prevalence abstinence was defined as complete abstinence from smoking for the 7 days up to and including the evaluation day.|Weekly assessment at Week 1, 2, 4, 6, 12 and Week 24|Analysis was carried out per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
1433299|NCT00985985|Secondary|Rate of Long-term Successful Smoking Cessation at Week 24|Rate of long-term successful smoking cessation at Week 24 was defined as the proportion of participants who achieved the primary end-point with no more than six cumulative days of smoking from Week 6 to Week 24.|From Week 6 to Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
1433300|NCT00985985|Secondary|Rate of Continuous Successful Smoking Cessation at Week 12 and Week 24|Continuous abstinence was verified by measurement of CO breath levels.|From baseline to Week 12 and Week 24|Analysis was done per FAS population. FAS population consisted of all randomized subjects who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
1433301|NCT00985985|Primary|Rate of Successful Smoking Cessation at Week 6|Rate of Successful Smoking Cessation at Week 6 was measured by Carbon Monoxide (CO) breath levels.|From baseline to Week 6|Analysis was considered per Full Analysis Set (FAS) population. FAS population consisted of all randomized participants who had study medication for at least once with assessment data post-dosing.|||Percentage of participants|||Number
1433302|NCT00985959|Secondary|Median Time to First Response - Phase II|Time to first response is the duartion of time required to achieve first response to treatment|up to 54 weeks|Full analysis set: All participants who received at least one dose of the study medication.|||Days||95% Confidence Interval|Median
1433303|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I|Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2|||ng/mL||Standard Deviation|Mean
1446885|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
1433305|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)|Day 4 of Cycle 2|Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2|||ng/mL||Standard Deviation|Mean
1433306|NCT00985959|Secondary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I|Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)|Day 25 of Cycle 1|Pharmacokinetics-evaluable population: 16 participants were included in pharmacokinetics-evaluable population|||ng/mL||Standard Deviation|Mean
1433307|NCT00985959|Primary|Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II|Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions|54 weeks|Full analysis set: All participants who received at least one dose of the study medication.|||Participants|||Number
1433308|NCT00985959|Primary|Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)|Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1|6 weeks|Dose Limiting Toxicity set, Which includes all 18 participants in the Phase I|||Participants|||Number
1433309|NCT00985946|Secondary|Evaluate the Overall Survival of Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat||Up to 5 years||||months||90% Confidence Interval|Median
1433310|NCT00985946|Secondary|Delineate the Expression of Notch 1 in Neuroendocrine Tumor Samples Before and During Treatment With Panobinostat|The expression of Notch 1 in neuroendocrine tumor samples will be evaluated prior to Cycle 1 Day 1 dose and at the end of Cycle 2 of treatment of treatment.|Pre-treatment and up to week 12|Data to delineate the expression of Notch 1 in neuroendocrine tumor samples was not collected. The question regarding the role of Notch1 in well-differentiated NET remains unanswered.||||||
1433311|NCT00985946|Secondary|Evaluate the Time to Progression for Patients With Gastrointestinal Neuroendocrine Tumors Treated With Panobinostat||Up to 5 years||||months||90% Confidence Interval|Median
1433312|NCT00985946|Secondary|Number of Participants With Toxicities|Evaluate the toxicity and tolerability of panobinostat in the patient population|up to 5 years||||participants|||Number
1433313|NCT00985946|Primary|Tumor Response Rate of Patients With Gastrointestinal Neuroendocrine Tumors Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria.|Confirmed anti-tumor response rate will be validated by the Response Evaluation Criteria in Solid Tumors (RECIST). All participants included in the study will be assessed for response to the proposed panobinostat treatment, even if there are protocol treatment deviations. Each participant will be assigned one of the following categories: complete response, partial response, stable disease, progressive disease, early death from malignant disease, early death from toxicity, early death because of other cause, or unknown.|every 8 weeks, up to 5 years||||participants|||Number
1433314|NCT00985829|Other Pre-specified|Past Medical History of Radiotherapy|past medical history of radiotherapy to the site of tumor before its appearance(for another reason)|baseline||||lesions|||Number
1433315|NCT00985829|Other Pre-specified|BCC Type|superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)|baseline||||lesions|||Number
1433316|NCT00985829|Other Pre-specified|Location of Lesion||baseline||||lesions|||Number
1433317|NCT00985829|Other Pre-specified|Cosmetic Result|excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration|1 month after termination of treatment course (with an average of 6 months after initiation of PDT)|cosmetic result was assessed among patients with complete response|||lesions|||Number
1433318|NCT00985829|Secondary|Histologic Resolution of Lesion|disappearance of the lesion in histologic examination|immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)|from those 9 lesions with clinically complete reponse , 3 lesions were biopsied and assessed histologically.|||lesions|||Number
1433319|NCT00985829|Primary|Clinical Response to Photodynamic Therapy|categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced|immediately after termination of treatment course (with an average of 5 month after initiation of PDT)||||lesions|||Number
1433320|NCT00985790|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs).|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1433321|NCT00985790|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 180 (study conclusion)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1433322|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination.|During the 28-day follow-up period (Days 0 to 27) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1433323|NCT00985790|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.|||subjects|||Number
1433324|NCT00985790|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day follow-up period (Days 0 to 6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.|||subjects|||Number
1433325|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1433326|NCT00985790|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1433327|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1433328|NCT00985790|Secondary|Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1433329|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1433340|NCT00985751|Secondary|Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations|Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||LU/mL||95% Confidence Interval|Geometric Mean
1441664|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
1433330|NCT00985790|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Day 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1433331|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1433332|NCT00985790|Secondary|Number of Seropositive Subjects Against 4 Strains of Influenza Disease.|A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||subjects|||Number
1433333|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.|At Days 0, 28 and Day 56|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1433334|NCT00985790|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.|At Days 0 and 28.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1433335|NCT00985790|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.|At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.|||titers||95% Confidence Interval|Geometric Mean
1433336|NCT00985751|Secondary|Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity|Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1433337|NCT00985751|Secondary|Antibody Concentrations to Protein D (Anti-PD)|Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||LU/mL||95% Confidence Interval|Geometric Mean
1433338|NCT00985751|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes|Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
1433339|NCT00985751|Secondary|Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations|Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).|One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1433341|NCT00985751|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1433342|NCT00985751|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) follow-up period after the booster dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
1433343|NCT00985751|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|During the 31-day (Days 0-30) follow-up period after each primary dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1433344|NCT00985751|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
1433345|NCT00985751|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.|During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.|||Participants|||Count of Participants
1433346|NCT00985751|Primary|Number of Subjects With Fever > 40.0°C (Rectal Temperature)|The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.|Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1433347|NCT00985751|Primary|Number of Subjects With Fever > 40.0°C (Rectal Temperature)|The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.|Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1433348|NCT00985738|Primary|To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.|The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.|24 Months|"The study was terminated. Study end points were not reached. No data were collected"||||||
1433349|NCT00985725|Secondary|Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9|The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents. The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32. Lower scores indicate reduced suicidal tendencies.|Baseline and week 9|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.|||Scores on a scale||Standard Deviation|Mean
1433350|NCT00985725|Secondary|Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF|The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity. Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.|Baseline and week 9|SAS|||Scores on a scale||Standard Deviation|Mean
1433351|NCT00985725|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Baseline and week 11|SAS population was used for this assessment. However, not all subjects from the SAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the SAS population.|||Scores on a scale||Standard Deviation|Mean
1433365|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24|Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter [mg/dL]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.|||number of events per 30 days||Standard Deviation|Mean
1433352|NCT00985725|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint|The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465. Higher scores indicate greater satisfaction.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||Scores on a scale||Standard Deviation|Mean
1433353|NCT00985725|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9|The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).|Baseline and week 9|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||Scores on a scale||Standard Deviation|Mean
1433354|NCT00985725|Secondary|Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|Only the females from the SAS population were used and not all of them completed this outcome assessment.|||Scores on a scale||Standard Deviation|Mean
1433355|NCT00985725|Secondary|Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF|This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.|Baseline and week 9|The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.|||Scores on a scale||Standard Deviation|Mean
1433356|NCT00985725|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint|The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.|Baseline and up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||Scores on a scale||Standard Error|Least Squares Mean
1433357|NCT00985725|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 9|FAS|||percentage of participants|||Number
1433358|NCT00985725|Secondary|Percent of Participants With CGI-S at up to 9 Weeks/Endpoint|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 9 weeks/Endpoint|FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.|||percentage of participants|||Number
1433359|NCT00985725|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline|FAS|||percentage of participants|||Number
1433360|NCT00985725|Secondary|Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint|This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity. Higher scores are better.|Baseline and up to 9 weeks/Endpoint|FAS|||Response scores||Standard Deviation|Mean
1433361|NCT00985725|Secondary|Change From Baseline in BRIEF-A T-scores at Week 9, LOCF|BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|FAS|||T-scores||Standard Error|Least Squares Mean
1433362|NCT00985725|Secondary|Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and week 9|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1433363|NCT00985725|Primary|Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)|BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline and week 9|The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.|||T-scores||Standard Error|Least Squares Mean
1433364|NCT00985712|Secondary|30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24|Hyperglycemic episode is defined as blood glucose measurement >18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.|Baseline through Week 24|Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.|||number of events per 30 days||Standard Deviation|Mean
1433366|NCT00985712|Secondary|Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint|IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.|Week 24|Participants in full analysis population set who had Week 24 measurements.|||units on a scale||95% Confidence Interval|Least Squares Mean
1433367|NCT00985712|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint||Week 24|Participants in full analysis population set who had Week 24 measurements.|||percentage of participants|||Number
1433368|NCT00985712|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment*visit interaction, screening HbA1c (≤9% / >9%), change of prandial insulin at baseline, and baseline HbA1c.|Baseline, Week 24|Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1433369|NCT00985686|Secondary|Spiritual Involvement and Belief Scale (SIBS)|Measure of spiritual well-being in 19 to 24 year olds. The instrument is self-administered and contains 26 items in a Likert-type format.|At 8 week intervals over a 24 week period|||||||
1433370|NCT00985686|Secondary|Spiritual Well-Being Scale (SWBS)|Measure of level spiritual well-being in 13-18 year olds. The self administered 10-item version was used.|At 8 week intervals over a 24 week period|||||||
1433371|NCT00985686|Secondary|Profile of Mood States (POMS)|Measure of psychological well-being in 19 to 24 year olds. The POMS has the format of an adjective check list and consists of 65 items. It provides a total score of mood disturbance and six factor based subscale scores.|At 8 week intervals over a 24 week period|||||||
1433372|NCT00985686|Secondary|Six Factor Self-Concept Scale|Measure of self concept in 19 to 24 year olds. The Six-Factor Self-Concept Scale is a multidimensional measure of adult self-concept that was designed to have broad applicability across life settings, roles, and activities. The scale consist of 115 items and assess six factors including likability, morality, task accomplishment, giftedness, power and vulnerability.|At 8 week intervals over a 24 week period|||||||
1433373|NCT00985686|Secondary|Piers-Harris Children’s Self-Concept Scale - Second Edition (Piers Harris 2)|Measure of self-concept in 13 to 18 year olds. The scale can be completed in 10-15 minutes and includes 60 items covering six subscales: physical appearance and attributes, intellectual and school status, happiness and satisfaction, freedom from anxiety, behavioural adjustment and popularity.|At 8 week intervals over a 24 week period|||||||
1433374|NCT00985686|Primary|Hamilton Depression Rating Scale (HAMD)|Measure of depression severity in individuals 19 to 24 years of age. HAMD total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression. To meet eligibility requirements, participants required a total score of 12-24.|At 8 week intervals over a 24 week period||||units on a scale||Standard Error|Mean
1433375|NCT00985686|Primary|Children's Depression Rating Scale Revised (CDRS-R)|Measure of depression severity in individuals 13 to 18 years of age. CDRS-R total raw scores includes the sum of 17 items, each item's scoring range is from 1 (no difficulties) to 5 (severe clinically significant difficulties) or 1 (no difficulties) to 7 (severe clinically significant difficulties), with a total possible raw score ranging from 17 to 113. To meet eligibility requirements, participants required a total raw score of 40 to 70.|At 8 week intervals over a 24 week period||||units on a scale||Standard Error|Mean
1433376|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after dose 1 vaccination|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Titers||95% Confidence Interval|Geometric Mean
1433377|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flulaval Vaccine Strains.|"Titers were expressed as geometric mean titers (GMTs).~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 0, 21 and 63 for the first 4 groups and on Days 0, 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433378|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Fold||95% Confidence Interval|Mean
1433387|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against A/California Strain.|Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the prevaccination reciprocal HI titer.|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Fold||95% Confidence Interval|Mean
1433379|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|On Days 21 and 63 from Day 0 for the first 4 groups and on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Fold||95% Confidence Interval|Mean
1433380|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 after the first dose|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Subjects|||Number
1433381|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|before vaccination and on days 21 and 63 for the first 4 groups and before vaccination and on days 42 and 63 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
1433382|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|At Day 182 from Day 0|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Subjects|||Number
1433383|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008."|on Days 21 and 63 from Day 0 for the first 4 groups; on Days 42 and 63 from Day 0 for the Unadjuvanted Arepanrix/placebo/Flulaval and Arepanrix/placebo/Flulaval Groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
1433384|NCT00985673|Secondary|Seroconversion Factor for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion factor was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal Hemagglutination Inhibition (HI) titer to the prevaccination reciprocal HI titer.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Fold||95% Confidence Interval|Mean
1433385|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against Flulaval Vaccine Strains|"Seroprotection was defined as the proportion of subjects with H1N1 reciprocal Hemagglutination Inhibition (HI) titers ≥ 1:40 against the tested vaccine virus.~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
1433386|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against Flulaval Vaccine Strains.|"Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer~Flulaval vaccines strains were A/Brisbane/59/2007 H1N1, A/Uruguay/716/2007 H3N2 and B/Brisbane/60/2008.~For the analysis the Flulaval/placebo/unadjuvanted Arepanrix Group and the Flulaval/placebo/Arepanrix Group were pooled."|At Day 21 from Day 0 for the pooled group, Flulaval/unadjuvanted Arepanrix/placebo and Flulaval/Arepanrix/placebo Groups; at Day 63 from Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Arepanrix/placebo/Flulaval Group|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
1433623|NCT00984022|Secondary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Cellulitis.|Participants were assessed to see whether or not the surface area of the cellulitis was reduced by at least 30% and the number of such participants was reported.|2 weeks||||Participants|||Number
1433388|NCT00985673|Secondary|Number of Seroprotected Subjects for Antibodies Against A/California Strain.|Seroprotection rate was defined as the proportion of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.|At Day 63 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 for the 4 other groups.|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
1433389|NCT00985673|Secondary|Number of Seroconverted Subjects for Antibodies Against A/ California Strain.|"Seroconversion rate was defined as the incidence rate of vaccinees who had either a pre-vaccination titer recorded as < 1:10 and a post-vaccination reciprocal titer ≥ 40 or a pre-vaccination reciprocal titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer.~Seroconversion defined as:~For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer"|At Day 63 from Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups; At Day 42 from Day 0 for the 4 other groups|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Subjects|||Number
1433390|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|At Day 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at Day 182.|||Titers||95% Confidence Interval|Geometric Mean
1433391|NCT00985673|Secondary|Geometric Mean Antibody Titers (GMTs) for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California H1N1 Strain.|Titers were expressed as geometric mean antibody titers (GMTs).|On Days 0, 21, 42 and 63|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433392|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Unadjuvanted Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433393|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to pre-treatment with two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (Day 63 for Arepanrix/placebo/Flulaval Group and Day 21 for Flulaval/placebo/unadjuvanted Arepanrix and Flulaval/placebo/Arepanrix Groups)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433394|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of the unadjuvanted formulation of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433395|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Flulaval Strains.|"The antibody response against each of the three Flulaval vaccine components in subjects exposed to co-administration of Flulaval vaccine with the first of two doses of Arepanrix vaccine and in subjects exposed to a single dose of Flulaval vaccine.~Flulaval vaccine strains were Flu A/Brisbane/59/2007 H1N1, Flu A/Uruguay/716/2007 H3N2 and Flu B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the Flulaval vaccination (at Day 21).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433407|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were serum urea nitrogen (SUN), white blood cells (WBC), red blood cells (RBC). For each parameter and for each range it was assessed whether the values of the subjects were unknown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
1446886|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
1433396|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects pre-treated with Flulaval who subsequently received two doses of the unadjuvanted formulation of Arepanrix vaccine compared to subjects pre-treated with Flulaval vaccine who subsequently received two doses of Arepanrix vaccine.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the pandemic vaccine (at Day 63)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433397|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (Day 63 for Flulaval/placebo/unadjuvanted Arepanrix Group and Day 42 for Unadjuvanted Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433398|NCT00985673|Secondary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received two doses of Arepanrix vaccine, with prior treatment with Flulaval vaccine 21 days before the first dose and in subjects having received two doses of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (Day 63 for Flulaval/placebo/Arepanrix Group and Day 42 for Arepanrix/placebo/Flulaval Group)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433399|NCT00985673|Secondary|Vaccine Response Rates (VRR) for Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~Vaccine Response Rate for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0.~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.||||||
1433400|NCT00985673|Secondary|Number of Subjects With a Microneutralization Titer Greater Than or Equal to 1:28 for Antibodies Against A/California/7/2009 (H1N1) Strain.|"Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~The antibody cut-off value assessed was a titer of 1:10 and this value was considered as seropositivity.~Seronegative subject is a subject whose antibody titer is below the cut-off value, a seropositive subject is a subject whose antibody titer is greater than or equal to the cut-off value. Microneutralization titers < 1:28 were considered below the cut-off.~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.||||||
1433401|NCT00985673|Secondary|Microneutralization Antibody Titers Against A/California/7/2009 (H1N1) Strain.|"Titers were expressed as geometric mean titers (GMTs) and measured by microneutralization.~Arepanrix vaccine strain and the unadjuvanted formulation of Arepanrix vaccine strain was A/California/7/2009 (H1N1).~Microneutralization testing was cancelled."|On Days 0, 21, 42, 63 and 182|Microneutralization testing was cancelled.||||||
1433402|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were neutrophils (NEU), lymphocytes (LYM), monocytes (MON) and platelets (PLA). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
1433403|NCT00985673|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|"The day 329 was the last contact day with the subjects reporting serious adverse events.~SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects."|During the entire study period (Days 0-329).|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
1433404|NCT00985673|Secondary|Number of Subjects Reporting Potential Immune Diseases (pIMDs).|The day 406 was the last contact day with the subjects reporting the event. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|During the entire study period (Days 0-406).|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
1433405|NCT00985673|Secondary|Number of Subjects Reporting Medically Attended Visits (MAEs).|The day 368 was the last contact day for the last subject reporting the event. For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.|During the entire study period (Days 0-368).|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
1433406|NCT00985673|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 84-day (Days 0-83) post-vaccination period.|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
1433408|NCT00985673|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature. Temperature is defined as an axillary temperature equal to or above 38.0 degrees Celsius (°C).|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
1433409|NCT00985673|Secondary|Number of Subjects Reporting Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling|During a 7-day follow-up period (Days 0-6) post-vaccination period|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
1433410|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were creatinine (CREA), bilirubin (BIL) (direct (D)), eosinophils (EOS), hemoglobin (Hgb), hematocrit (Hct). For each parameter and for each range it was assessed whether the values of the subjects were unknown, in above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated cohort included all vaccinated subjects|||Subjects|||Number
1433411|NCT00985673|Secondary|Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemical and Haematological Parameters Assessed|Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), bilirubin (BIL) (total (T)), basophils (BAS). For each parameter and for each range it was assessed whether the values of the subjects were in unkown, above, below or within the range.|On Days 0, 7, 21, 28, 42, 63 and 182|The Total Vaccinated Cohort included all vaccinated subjects.|||Subjects|||Number
1433412|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 8 (CD8) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD8 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.~Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.|||Number of T cells/million||Standard Deviation|Mean
1433413|NCT00985673|Secondary|Number of Influenza-specific Cluster of Differentiation 4 (CD4) T-cells Per Million Producing Two or More Markers Within Cluster Differentiation 40 Ligand (CD40L), Interleukin-2 (IL-2), Interferon-γ (IFN-γ) and Tumor Necrosis Factor-α (TNF-α).|"Influenza-specific CD4 T-Cells were stimulated in vitro with A/California virus and seasonal Influenza viruses, related antigens or derived peptides.~Stimulating antigens were A/Brisbane, A/California, pool peptides H1N1 and pool FLU."|On Days 0, 7, 21, 28, 42, 63 and 182|The According-To-Protocol (ATP) cohort for immunogenicity at Day 182 included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) for whom 1 dose of Flulaval vaccine and 2 doses of pandemic vaccine were administered and results were available for antibodies against H1N1 antigen at day 182.|||Number of T cells/million||Standard Deviation|Mean
1433414|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of the unadjuvanted formulation of Arepanrix vaccine, and in subjects having received two doses of the unadjuvanted formulation of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of the unadjuvanted formulation of Arepanrix vaccine (at Day 42)|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433415|NCT00985673|Primary|Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain.|"The A/California vaccine virus-homologous antibody response was measured in subjects having received Flulaval vaccine co-administered with the first dose of Arepanrix vaccine, and in subjects having received two doses of Arepanrix vaccine alone.~Titers were expressed as geometric mean antibody titers (GMTs)."|21 days after the second dose of Arepanrix vaccine (at Day 42).|The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, with no elimination criteria) who received 2 doses and for whom assay results were available for antibodies against H1N1 antigen 21 days after the 2nd vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1433416|NCT00985543|Secondary|Adverse Events|Number of reported adverse events, severity of adverse events and relationship to study drug was assessed by questions, physical examination and laboratory parameters. Adverse event data was used to assess the safety and tolerability of low lopinavir/ritonavir doses.|Up to 11 weeks from screening to final study visit|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).|||number of adverse events|||Number
1433417|NCT00985543|Primary|Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h).|Pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval following administration of lopinavir/ritonavir 400/100mg, 200/150mg and 200/50mg twice daily.|at the end of each 7-day dosing phase|22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).|||ng.h/mL||90% Confidence Interval|Geometric Mean
1433418|NCT00985504|Secondary|Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks|Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion.|Baseline through 8 weeks|All randomized participants.|||percentage of participants|||Number
1433442|NCT00985166|Primary|Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||ELISA AB units/mL||95% Confidence Interval|Geometric Mean
1433419|NCT00985504|Secondary|Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks|The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score≥16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored).|Baseline through 8 weeks|Number of participants in each treatment group having time to relapse plus the participants censored. Duloxetine had 200 participants censored and escitalopram had 199 participants censored.|||days|||Number
1433420|NCT00985504|Secondary|Percentage of Participants Who Relapsed During 8 Weeks|Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score≥16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline through 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||percentage of participants|||Number
1433421|NCT00985504|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8|The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1433422|NCT00985504|Secondary|Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8|"The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 2 (normal) to 6 (totally absent). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline."|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1433423|NCT00985504|Secondary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8|MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1433424|NCT00985504|Secondary|Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8|The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1433425|NCT00985504|Secondary|Patient’s Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8|The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit.|8 weeks|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
1433426|NCT00985504|Secondary|Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8|RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline at and least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1433427|NCT00985504|Secondary|Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8|AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1433537|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)|Change from baseline (CFB) in PT-INR (ratio).|baseline and 48 weeks|TS|||ratio||Standard Deviation|Mean
1433428|NCT00985504|Primary|Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8|The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.|Baseline, 8 weeks|All randomized participants with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
1433429|NCT00985491|Secondary|Improvement in Type 2 Diabetic Status|Subjects who achieved HbA1c reduction of 0.5%|12 months|7 subjects were enrolled that had Type 2 Diabetes; endpoint evaluated subjects who achieved HbA1c reduction of 0.5%|||% of subjects with T2DM|||Number
1433430|NCT00985491|Primary|Assessment of % Excess Weight Loss|Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as [(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)] * 100).|12 months||||%EWL||Standard Error|Mean
1433431|NCT00985439|Primary|Total Patient Pain Relief Over 0 to 12 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-12 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60."|12 hours.||||units on a scale||95% Confidence Interval|Least Squares Mean
1433432|NCT00985257|Primary|Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.|1-2 hours|To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.|||percent of blood glucose results|Participants||Number
1433433|NCT00985231|Secondary|Subjective Ratings of Eye Strain|Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always|2 week visit|All Eligible, Dispensed Eyes, CISS Composite Score|||CISS Composite Score||Standard Deviation|Mean
1433434|NCT00985231|Primary|Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.|Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.|2 weeks|All Eligible, Dispensed Eyes with non-missing scores|||eyes|Participants||Number
1433435|NCT00985192|Secondary|Biomarker Correlations: Time to Progression|Potential correlations between time to progression and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"|||months||95% Confidence Interval|Median
1433436|NCT00985192|Secondary|Biomarker Correlations: Progression Free Survival|Potential correlations between progression free survival and S6 protein and mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"|||months||95% Confidence Interval|Median
1433437|NCT00985192|Secondary|Observed Biomarkers|Potential correlations between clinical outcome and biomarkers of interest, including S6 protein overexpression and/or other mTOR-related proteins in tumor tissue samples from these patients.|30 months|"Exploratory analysis of translational endpoints in patient samples, Representative paraffin blocks were required for all participating patients. Tissue blocks were obtained on 39 patients.~p-s6 and p-mTOR IHC expression in tumors"|||number of tissue blocks|||Number
1433438|NCT00985192|Secondary|Efficacy in Terms of Progression Free Response|Progression-free survival (PFS), was defined as the time from the date of initial treatment to first objective documentation of disease progression, or death. Estimated using the Kaplan–Meier method. Complete response (CR) + partial response (PR) + stable disease (SD) were determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Radiologic disease assessments were utilized.|evry 3 months in year 1, every 6 months after that||||months||95% Confidence Interval|Median
1433439|NCT00985192|Secondary|Overall Survival|Overall Survival (OS), defined as the time from date of initial treatment to date of death. Survival function was estimated using the Kaplan–Meier method.|2.5 year||||months||95% Confidence Interval|Median
1433440|NCT00985192|Primary|Overall Disease-control Rate in Patients With Previously Treated Unresectable or Metastatic Adenocarcinoma of the Upper Gastrointestinal Tract Treated With Everolimus.|Disease control rate (DCR), defined as complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.|Radiologic disease assessment was performed every 8 weeks (14 days = 1 cycle) treatment discontinuation.||||percent subjects with disease control||95% Confidence Interval|Number
1433441|NCT00985166|Primary|Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
1433538|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)|Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.|baseline and 48 weeks|TS|||U/L||Standard Deviation|Mean
1433443|NCT00985166|Primary|Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
1433444|NCT00985166|Primary|Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1433445|NCT00985153|Primary|Number of Participants With Serious Vaccine-related CAEs|Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).|6 weeks Postvaccination|All subjects with follow-up for safety were included in the analysis.|||Participants|||Number
1433446|NCT00985153|Primary|Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Rubella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||ELISA AB units||95% Confidence Interval|Mean
1433447|NCT00985153|Primary|Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Mumps.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||ELISA AB units||95% Confidence Interval|Mean
1433448|NCT00985153|Primary|Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline – Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Measles.|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Mean
1433449|NCT00985153|Primary|Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer|Postvaccination observed Geometric Mean Titer of antibody to Varicella|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer < 1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||gpELISA||95% Confidence Interval|Mean
1433450|NCT00985153|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
1433451|NCT00985153|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
1433452|NCT00985153|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
1433453|NCT00985153|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||Participants|||Number
1433454|NCT00985140|Primary|Clinical Response Rate|"After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy.~The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease."|1 year|All patients who completed treatment.|||participants|||Number
1433455|NCT00985114|Primary|Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.||6 months||||% of participants|||Number
1433456|NCT00985088|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Results were tabulated for subjects aged between 18-64 years and older (>64y).|During the entire study period (from Day 0 to Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1433539|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)|Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.|baseline and 48 weeks|TS|||mmol/L||Standard Deviation|Mean
1433457|NCT00985088|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18-64 years and older (>64y).|Within the 84-day (Days 0-83) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1433458|NCT00985088|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1433459|NCT00985088|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Results were tabulated for subjects aged between 18-64 years and above 65 years (+65y).|Days 0 to 365|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1433460|NCT00985088|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any MAE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18 and 64 years and older (>64y).|Days 0 to 385|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1433461|NCT00985088|Secondary|Number of Subjects With Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.|At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1433462|NCT00985088|Secondary|Number of Subjects With Abnormal Biochemical and Haematological Levels|"Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC].~Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – unknown, below, within and above the reference range defined for the specified time point and laboratory parameter."|At Days 7, 21, 28, 42 and 182, for subjects between 18-64 years of age|The analysis was performed on the Total Vaccinated cohort included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1433463|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).|During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in. This analysis focused on subjects who received an additional dose of GSK2340273A F2 vaccine from GSK2340273A F2_1D Group.|||Participants|||Count of Participants
1433464|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).|During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in. This analysis focused on subjects who received an additional dose of GSK2340273A F2 vaccine from GSK2340273A F2_1D Group.|||Participants|||Count of Participants
1433540|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)|Change from baseline (CFB) in Platelets and white blood cells.|baseline and 48 weeks|TS|||10^9 cells/L||Standard Deviation|Mean
1433541|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)|Change from baseline (CFB) in haematocrit and Eosinophils.|baseline and 48 weeks|TS|||% of laboratory test substance||Standard Deviation|Mean
1433465|NCT00985088|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
1433466|NCT00985088|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
1433467|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
1433468|NCT00985088|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least 1 study vaccination and had their symptom sheets filled in.|||Participants|||Count of Participants
1433469|NCT00985088|Secondary|Adjusted GMT Ratios for A/California Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F1_1D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine vs. GSK2340273A F1_1D vaccine|||Titer|||Number
1433470|NCT00985088|Secondary|Adjusted GMT Ratios for A/California Virus Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F2 and GSK2340273A F2.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine versus GSK2340273A F2 vaccine|||Titer|||Number
1433471|NCT00985088|Secondary|Adjusted GMT Ratios of A/California Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F3_2D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F2 vaccine versus GSK2340273A F3 vaccine|||Titer|||Number
1433472|NCT00985088|Secondary|Adjusted GMT Ratios of A/California Virus Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and the GSK2340273A F1_1D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine vs GSK2340273A F1_1D vaccine|||Titer|||Number
1433473|NCT00985088|Secondary|Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F1 and GSK2340273A F2.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine versus GSK2340273A F2 vaccine|||Titer|||Number
1433474|NCT00985088|Secondary|Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain|Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and GSK2340273A F3_2D Group.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity,which included all subjects who received the vaccine/placebo doses on Days 0 and 21 and for whom assay results for antibodies against vaccine antigen for blood samples taken were available. This analysis focused on subjects receiving GSK2340274A F1 vaccine versus GSK2340273A F3 vaccine|||Titers|||Number
1433475|NCT00985088|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1433476|NCT00985088|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433477|NCT00985088|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433478|NCT00985088|Secondary|Titers for HI Antibodies Against the A/California Virus Strain|Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Titers||95% Confidence Interval|Geometric Mean
1433479|NCT00985088|Secondary|Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 182|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433480|NCT00985088|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1433481|NCT00985088|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433482|NCT00985088|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433483|NCT00985088|Secondary|Titers for HI Antibodies Against the A/California Virus Strain|Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Titers||95% Confidence Interval|Geometric Mean
1433484|NCT00985088|Secondary|Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433485|NCT00985088|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1433486|NCT00985088|Secondary|Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers ≥ 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433487|NCT00985088|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433488|NCT00985088|Secondary|Titers for HI Antibodies Against A/California Strain|Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Titers||95% Confidence Interval|Geometric Mean
1433489|NCT00985088|Secondary|Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who received the vaccine/ placebo doses on both Days 0 and 21 and from whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433490|NCT00985088|Primary|Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (>64y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1433491|NCT00985088|Primary|Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain|SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (>60y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1433492|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433493|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433494|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years and older (>60y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433495|NCT00985088|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) and results were tabulated for subjects between 18 and 60 years and older (>60y).|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433496|NCT00985088|Primary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (>64y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433497|NCT00985088|Primary|Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥ 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (>60y).|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433498|NCT00985088|Primary|Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433499|NCT00985088|Primary|Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433500|NCT00985088|Primary|Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects > 60 years.|At Day 21|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the ATP cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on both Days 0 and 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433501|NCT00985088|Primary|Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain|A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (≥) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (>) 60 years.|At Day 0|The analysis was performed only on subjects receiving F1 or F2 of GSK2340274A vaccine from the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who received the vaccine/placebo doses on Days 0, 21 and for whom assay results for antibodies against A/California-like HA antigen for blood samples taken were available.|||Participants|||Count of Participants
1433502|NCT00985010|Secondary|Manganese Levels|From encephalopathic patients, we took individual blood samples, analyzed in the biochemistry laboratory at the National Institute of Neurology and Neurosurgery, Mexico, City, with a graphite furnace atomic absorption spectrometer, according to the technique reported by Pleban.|Up to six months we followed the recruited patients to determine who were still alive|All patients attended at the Internal Medicine Service with Hepatic Encephalopathy were included. The analysis was per protocol.|||μg/L||Standard Deviation|Mean
1433503|NCT00985010|Primary|Clinical Evolution|Number of participants who died versus those who remained alive after 6 months of follow up since the first entrance at the Emergency Room|six months|We made a clinical follow up from nine encephalopathic patients. After six months we studied the differences in Mn, hemoglobin, etc., between those patients still alive and those who died.|||participants|||Number
1433504|NCT00984867|Secondary|Proportion of Participants Achieving a Therapeutic Glycemic Response Defined as a Reduction in HbA1c of ≥0.7% Compared to Baseline|To compare the proportion of participants achieving a therapeutic glycaemic response, defined as a reduction in HbA1c of ≥0.7% compared to baseline, with dapagliflozin versus placebo at week 24. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1433505|NCT00984867|Secondary|Adjusted Mean Change in 2-hour Post Liquid Meal Glucose Rise|To compare the change in 2-hour post liquid meal glucose rise achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1433506|NCT00984867|Secondary|Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) in Participants With Baseline SBP>=130 mmHg|To compare the change in seated systolic blood pressure (SBP) in participants with baseline seated SBP >=130 achieved with dapagliflozin versus placebo from baseline to week 8.|Baseline to Week 8|Full analysis set, participants with baseline SBP>=130mmHg and Week 8 (LOCF) value|||mmHg||95% Confidence Interval|Least Squares Mean
1433507|NCT00984867|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG)|To compare the change in FPG achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1433508|NCT00984867|Secondary|Adjusted Mean Change in HbA1c in Participants With Baseline HbA1c ≥8%|To compare the change in HbA1c in participants with baseline HbA1c ≥8% achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full analysis set, participants with baseline HbA1c >=8% and Week 24 (LOCF) value|||Percent||95% Confidence Interval|Least Squares Mean
1433509|NCT00984867|Secondary|Adjusted Mean Change in Body Weight|To compare the change in total body weight achieved with dapagliflozin versus placebo from baseline to week 24.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1433510|NCT00984867|Primary|Adjusted Mean Change in HbA1c Levels|To compare the change from baseline in HbA1c after 24 weeks treatment (LOCF) between dapagliflozin and placebo in patients with type 2 diabetes who are inadequately controlled on sitagliptin alone or on sitagliptin plus metformin.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percent||95% Confidence Interval|Least Squares Mean
1433511|NCT00984815|Secondary|Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health.|Baseline and 54 Weeks|55 participants who completed the satisfaction with dyspepsia-related health questions of the SODA questionnaire at baseline and week 54.|||Scores on a scale||Standard Deviation|Mean
1433512|NCT00984815|Secondary|Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.|||Scores on a scale||Standard Deviation|Mean
1433513|NCT00984815|Primary|Number of Participants With Treatment Emergent Adverse Events||54 weeks|All participants enrolled and who received at least one dose of study drug comprised the Safety Population.|||participants|||Number
1433514|NCT00984815|Secondary|Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks|The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.|Baseline and 54 Weeks|54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.|||Scores on a scale||Standard Deviation|Mean
1433515|NCT00984698|Primary|Depression|Hamilton Rating Scale for Depression, 17 item The Hamilton Rating Scale for Depression is an interview assessment of depression symptom severity. Total score range is from 0 (no symptoms of depression) to 52 (maximum symptoms of depression).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants completed 75% of psychotherapy sessions; 20 participants completed study assessment at 12-week post-treatment time point~PCGT arm: 14 participants completed 75% of psychotherapy sessions; 17 participants completed study assessment at 12-week post-treatment time point"|||units on a scale||Standard Deviation|Mean
1433516|NCT00984698|Secondary|PTSD|Clinician-Administered PTSD Scale (CAPS), DSM-IV The CAPS is a 17-item interview assessment post-traumatic stress disorder (PTSD) symptom severity. Total score ranges from 0 (no PTSD symptoms) to 136 (maximum PTSD symptoms).|post-treatment, at 12 weeks|"CBSRT arm: 18 participants who completed 75% of psychotherapy sessions; 20 participants who completed 12-week post-treatment assessment~PCGT arm: 14 participants who completed 75% of psychotherapy sessions; 17 participants who completed 12-week post-treatment assessment"|||units on a scale||Standard Deviation|Mean
1433542|NCT00984620|Secondary|Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)|Change from baseline (CFB) in Red blood cells.|baseline and 48 weeks|TS|||10^12 cells/L||Standard Deviation|Mean
1433543|NCT00984620|Secondary|Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination|No number of participants with clinically relevant abnormalities in vital signs and physical examination.|48 weeks|TS|||participants with abnormality|||Number
1441665|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
1433517|NCT00984659|Primary|SOBDA Threshold for Response Assessed as Mean Change From Baseline to Last Treatment Week in the SOBDA Score Based on Forced Expiratory Volume in One Second (FEV1) Change From Baseline of 50 Milliliters (mL) to <100 mL|FEV1 response was rated as 1=No change or worse (i.e., change of <50 mL); 2=Better (i.e., change of 50 to <100 mL); 3=Much better (i.e., change of >=100 mL). The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on study assessment (FEV1) scores pre-specified as “better” or demonstrating meaningful improvement.|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||mL||Standard Deviation|Mean
1433518|NCT00984659|Primary|SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CRQ-SAS Dyspnea Domain (DD) Response Rated as “Better”|The threshold of response (TOR) is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit. The TOR was evaluated as the change from Baseline in the SOBDA score based on CRQ-SAS scores pre-specified as “better” or demonstrating meaningful improvement. The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing).|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
1433519|NCT00984659|Primary|SOBDA Threshold for Response as Assessed by Mean Change From Baseline to the Last Treatment Week in the SOBDA Score Based on a CGI-C Response Rated as “Better”|The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on CGI-C scores pre-specified as “better” or demonstrating meaningful improvement. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse, 2, worse; 3, no change; 4, better; 5, much better.|Baseline and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
1433520|NCT00984659|Primary|SOBDA Threshold for Response Assessed as Mean Change From the Previous Week’s SOBDA Score Based on a Participant-completed PGAC Score Rated of “Better”|Changes from Baseline in the SOBDA score for responders (Rs) and non-responders (NRs) (using the PGAC assessment; 1 [much worse] to 5 [much better]), together with the cumulative proportions of Rs and NRs, was used to establish the threshold for defining SOBDA questionnaire Rs. The threshold of response is a score change in the SOBDA questionnaire that is demonstrated to have a perceivable benefit for the participant. The threshold of response was evaluated as the change from Baseline in the SOBDA score based on PGAC scores pre-specified as “better” or demonstrating meaningful improvement.|Baseline (last week of the 2-week Run-in Period) and Weeks 1, 2, 3, 4, 5, and 6 (6-week Treatment Period)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||scores on a scale||Standard Deviation|Mean
1433521|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by Physician-completed mMRC and Participant-completed mMRC Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The mMRC ranges from 0 (no breathlessness except with strenous exercise) to 4 (too breathless to leave the house; breathless when dressing/undressing) and is completed by the clinician or the participant as indicated. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the Physician-completed (Ph-C) and Participant-completed (Pa-C) mMRC conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
1433522|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CRQ-SAS Dyspnea Domain (DD) Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes of responders (Rs) versus non-responders (NRs). The CRQ-SAS DD includes 5 questions (q.) scored 1 (maximum impairment) to 7 (no impairment). Individual q. were equally weighted, and domain scores (DSs) (range=1-7) were calculated as the mean across the non-missing items within each domain (DSs were calculated although an individual item score was missing). Changes in mean SOBDA scores during the last treatment week in Rs and NRs using definitions based on the CRQ-SAS DD conducted at Visit 3/PD were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||Scores on a scale||Standard Deviation|Mean
1433624|NCT00984022|Secondary|Change in Patient Rating of Pain|Change in mean pain score based on patient self-report, using Wong-Baker FACES pain rating scale. Scale ranges from 0 to 5, where 5 means the worst pain possible and 0 means no pain at all.|Baseline and 2 weeks||||Scores on a scale||Standard Deviation|Mean
1433523|NCT00984659|Primary|Change From Baseline to Last Treatment Week in the SOBDA Score by CGI-C Responses at Visit 3/PD|The responsiveness of the SOBDA questionnaire was assessed by comparing score changes between responders and non-responders. The CGI-C is clinician completed on a 1 to 5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Changes in mean SOBDA scores during the last week of treatment in responders and non-responders using definitions based on the CGI-C conducted at Visit 3/Premature Discontinuation were assessed.|Baseline (2-week Run-in Period) and Week Prior to Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||scores on a scale||Standard Deviation|Mean
1433524|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Physician-completed and Participant-completed mMRC Response at Visit 3/PD|A Physician-completed and Participant-completed mMRC responder was defined as a participant who had a score decrease of one unit or more between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had the same score or an increase in score.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||participants|||Number
1433525|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by CRQ-SAS Dyspnea Domain Response at Visit 3/PD|A CRQ-SAS dyspnea domain responder was defined as a participant who had a score increase of 0.5 units or more for the dyspnea domain of the CRQ-SAS between Visit 2 and Visit 3/Premature Discontinuation. A non-responder was defined as a participant who had a decrease in the score, or an increase of less than 0.5 units.|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||participants|||Number
1433526|NCT00984659|Primary|Number of Participants Classified as Responders and Non-responders by Clinician Global Impression of Change Question (CGI-C) Response at Visit 3/PD|"Clinicians were asked to provide their clinical impression regarding change in the participant’s shortness of breath by CGI-C. This was evaluated on a 1-5 Likert scale: 1 (much worse) to 5 (much better), with 3 being no change. A CGI-C responder was defined as a participant who had a response of better (4) or much better (5), and a non-responder was defined as a participant who had a response of much worse (1), worse (2), or no change (3)."|Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||participants|||Number
1433527|NCT00984659|Primary|Change From the Previous Week to the Current Week’s SOBDA Score by Participant-completed PGAC Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/PD (End of the 6-week Treatment Period or PD)|"Responsiveness reflects the ability of the SOBDA questionnaire to detect change under conditions of known change. Responders (Rs)=participants (par.) with a rating of better/much better (score of 4/5) on the PGAC (range; 1 [much worse] to 5 [much better]) at the relevant week; NRs=par. with a response of “much worse, worse, or no change (score of 3). Mean difference between Rs and NRs in the change from the previous week to the current week’s SOBDA score was calculated. For Visit 3/PD, the change from Baseline to the last treatment week's SOBDA score for Rs and NRs was calculated."|Baseline; Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|MITT Population. Analyses were conducted on data available for each specified time point. As pre-specified in the study protocol, results are presented independent of treatment allocation. The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect.|||scores on a scale||Standard Deviation|Mean
1433528|NCT00984659|Primary|Participants (Par.) Classified as Responders/Non-responders According to the Patient Global Assessment of Change (PGAC) Response at Days 8, 15, 22, 29, 36, and 43 and at Visit 3/Premature Discontinuation (PD) (the End of the 6-week Treatment Period or PD)|"The PGAC is par. completed on a 1-5 scale: 1, much worse; 2, worse; 3, no change; 4, better; 5, much better. Responders were defined as par. with a rating of better or much better (score of 4 or 5) on the PGAC at the relevant week; non-responders were defined as par. with a response of “much worse, worse, or no change on the PGAC. As pre-specified in the study protocol, results are presented independent of treatment allocation . The study objectives were to assess the measurement properties and validity of the SOBDA questionnaire independent of specific treatment effect."|Days 8, 15, 22, 29, 36, and 43 and Visit 3/PD (end of 6-week Treatment Period or earlier up to Week 8)|Modified Intent-to-Treat (MITT) Population: all participants randomized to treatment who received at least one dose of study medication. Analyses were conducted on data available for each specified time point.|||participants|||Number
1433529|NCT00984659|Primary|Known Group Validity (KGV) for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of CGI-S Scores at Visit 2|SOBDA KGV refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the CGI-S score. Clinicians were asked to assess the severity of the participant’s dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe). KGV was confirmed if the SOBDA score increased with increasing values of CGI-S, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatement on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the CGI-S score at Visit 2 were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1433625|NCT00984022|Primary|Number of Participants Who Experienced a 30% or Greater Reduction in Surface Area of Abscess|Participants were assessed to see whether or not the surface area of the abscess was reduced by at least 30%, and the number of such participants is reported.|2 weeks||||Participants|||Number
1433530|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Participant-completed (ParC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the ParC mMRC. The participant rated the degree of his/her dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of ParC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Participant-completed mMRC score at Visit 2 were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1433531|NCT00984659|Primary|Known Group Validity for the SOBDA Questionnaire Measured as the Comparison of the Baseline SOBDA Score in the Indicated Categories of the Physician-completed (PyC) mMRC Score at Visit 2|SOBDA known group validity refers to the extent to which scores from the SOBDA questionnaire should differentiate participants with varying levels of dyspnea severity. It was assessed by comparing summary measures for the SOBDA score for each indicated level (0, 1, 2, 3, and 4) of the PyC mMRC. The physician rated the degree of the participant's dyspnea on the 5-point mMRC scale: 0 (none) to 4 (very severe). Known group validity was confirmed if the SOBDA score increased with increasing values of PyC mMRC, both indicating increased levels of breathlessness.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the Physician-completed mMRC score at Visit 2 were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1433532|NCT00984659|Primary|Convergent Validity (CV) for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) Dyspnea Domain Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the CRQ-SAS dyspnea domain score. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 will occur if the data from the 2 variables lie exactly on a line. The CRQ is a 20-item instrument measuring 4 domains (each measured on a scale of 1 [maximum impairment] to 7 [no impairment]) of functioning: mastery, fatigue, emotional function, and dyspnea.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.|||Pearson's correlation coefficient|||Number
1433533|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as the Correlation of the Baseline SOBDA Score With the Clinician Global Assessment of Dyspnea Severity (CGI-S) Score at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure the required information and was assessed by examining the relationship between the SOBDA score with the CGI-S score. Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other. Clinicians were asked to assess the severity of the participant’s dyspnea on the CGI-S scale. This was evaluated on a 1-4 Likert scale: 1 (mild) to 4 (very severe).|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed.|||Spearman rank correlation coefficient|||Number
1433534|NCT00984659|Primary|Convergent Validity for the SOBDA Questionnaire Measured as Correlations of the Baseline SOBDA Score With Participant-completed Modified Medical Research Council (mMRC) and Physician-completed mMRC Scores at Visit 2|Convergent validity is defined as the ability of the SOBDA questionnaire to measure required information and was assessed by examining the relationship between the SOBDA score and the participant/physician-completed mMRC Dyspnea Scale assessments. The physician/participant rated the degree of the participant's dyspnea (trouble breathing) on the 5-point mMRC scale (0, none; 4, very severe). Spearman's rank correlation coefficient assesses if the relationship between two variables is monotone. A correlation of +1 or -1 will occur if one variable is a perfect monotone of the other.|Baseline (last week of the 2-week Run-in Period) and pre-treatment on Visit 2 (Day 1 of the 6-week Treatment Period)|Run-in Population. Participants with a SOBDA Baseline score and the indicated assessment at Visit 2 were analyzed. One participant who rated their own trouble breathing had missing data for the physician assessment.|||Spearman rank correlation coefficient|||Number
1433535|NCT00984659|Primary|Test-retest Reliability (T-RR) of SOBDA Scores Measured as the Difference in the SOBDA Weekly Score Between Week 1 and Week 2 of the 2-week Run-in Period|T-RR=stability during repeat measures over time in a stable population. SOBDA score was determined by the 13-item (it.) scoring algorithm, assigning a weekly mean score of 1-4 (higher scores=more severe breathlessness with daily activities) based on the mean of 7 days of data (or >=4 days). Daily total score is computed from the mean of the participant's (par.) scores on the 13 it. (>=7 it. must have non-missing responses). Only scores of stable par. (indicating no change [score=3] on the par.-completed Patient Global Assessment of Change [PGAC]; 1 [ much worse] to 5 [much better]) were used.|Week 1 and Week 2 of the 2-week Run-in Period|Run-in Population. Data from participants with weekly SOBDA scores at Week 1 and Week 2 of the 2-week Run-in Period and reporting no change on the second weekly PGAC were analyzed.|||scores on a scale||Standard Deviation|Mean
1433536|NCT00984659|Primary|Internal Consistency (IC) of the Shortness of Breath With Daily Activities (SOBDA) Questionnaire in Participants With Chronic Obstructive Pulmonary Disease (COPD) Assessed as Cronbach's Alpha Value|Cronbach’s alpha (CA) is a measure of the IC of the 13-item SOBDA questionnaire (completed via electronic diary by a sample of participants). It is the ratio of the variance (var.) of the sum of the individual scores and the var. of the total score. The var. of the sum of a group of independent variables is the sum of their var.; thus, if the variables are positively correlated, the var. of the sum will be increased. If the items making up the score are identical and so perfectly correlated, CA=1. If the items are independent, CA=0. Higher scores indicate a more reliable (precise) instrument.|Day 1 of the 2-week Run-in Period|Run-in Population: all participants who completed Visit 2 (Day 1 of Treatment Period), including those who were not randomized, were randomized but did not receive a dose of study medication, and those who were randomized and received study medication. Participants with a score for each SOBDA item on Day 1 of the 2-week Run-in Period were analyzed.|||ratio of variance|||Number
1433544|NCT00984620|Secondary|Laboratory Test Abnormalities and Study Medication Tolerabilities|Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.|48 weeks|Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.|||participants|||Number
1433545|NCT00984620|Secondary|Time to Reach a Plasma HCV RNA Level BLD While on Treatment|Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment|48 weeks|PPS|||week||Inter-Quartile Range|Median
1433546|NCT00984620|Secondary|Viral Load (HCV RNA) at All Visits During Treatment and Follow-up|Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.|From baseline to 72 weeks|PPS|||IU/mL||Standard Deviation|Mean
1433547|NCT00984620|Secondary|Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy|Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.|72 weeks|PPS|||participants|||Number
1433548|NCT00984620|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.|up to 48 weeks|PPS|||participants|||Number
1433549|NCT00984620|Secondary|Virological Response at Week 36 (W36VR)|Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.|36 weeks|PPS|||participants|||Number
1433550|NCT00984620|Secondary|Virological Response at Week 24 (W24VR)|virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.|24 weeks|PPS|||participants|||Number
1433551|NCT00984620|Secondary|Rapid Virological Response at Week 4 (RVR)|Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.|4 weeks|PPS|||participants|||Number
1433552|NCT00984620|Primary|Virological Response at Week 28 (W28VR)|Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.|28 weeks|Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.|||participants|||Number
1433553|NCT00984594|Secondary|Lysholm Score at 24 Months|The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
1433554|NCT00984594|Secondary|Magnetic Resonance Imaging (MRI) Results|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
1433555|NCT00984594|Secondary|IKDC Assessment|The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
1433556|NCT00984594|Secondary|Current Health Assessment (CHA)|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0–100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
1433557|NCT00984594|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months|Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.|||units on a scale||Full Range|Mean
1433558|NCT00984568|Primary|Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50|Response at Week 4 was defined as a minimum decrease from baseline in Mayo score of 3 points and 30%. Steroid-free remission at Week 50 was defined as a total Mayo score (including endoscopic assessment) of 2 points or lower and no individual subscore exceeding 1. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician’s global assessment. Each subscore is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst).|Week 50|The FAS consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1433559|NCT00984568|Secondary|Number of Participants Achieving Treatment Response|"Response was defined as a minimum decrease from baseline in total Mayo score of 3 points and 30% up to and including 4 weeks after the start of treatment. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician’s global assessment. Each subscore~is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst)."|Up to Week 4|The full analysis set (FAS) consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Number
1436790|NCT00959660|Primary|Exercise Capacity|Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.|20 weeks||||ml/kg/min||95% Confidence Interval|Mean
1433560|NCT00984542|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1433561|NCT00984542|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
1433562|NCT00984542|Secondary|Best Response|"Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details):~complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On‐treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response. 8 patients were not evaluable.|||participants|||Number
1433563|NCT00984542|Secondary|Number of Patients With Each Worst-grade Toxicity|Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.|Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days|Total number of patients reported with any toxicity|||participants|||Number
1433564|NCT00984542|Primary|Time to Progression|Estimated probable duration from on-study date to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)|All patients are included in the analysis on intention-to treat basis. Analysis is by Kaplan‐Meier method, where progression is an event, with censoring for non-progressed patients at greater of off‐study date, last known alive date, or date of death not attributable to disease progression.|||days||95% Confidence Interval|Median
1433565|NCT00984490|Secondary|Changes in Circulating Insulin-like Growth Factor 1 (IGF-1) and IGF Binding Protein 3 (IGFBP-3)|Effect of study drug on circulating IGF-1 and IGFBP-3 as measured in ng/mL in peripheral blood samples taken pre-treatment and post-treatment with metformin|baseline and 23 days|No levels of IGF-1 and IGFBP-3 were determined. This clinical trial was closed due to slow accrual.|||units on a scale||Standard Deviation|Mean
1433566|NCT00984490|Primary|Change in Ki67 Levels Before and After Treatment|Change in Ki67 levels in pre-treatment, pre-surgery and post-treatment, surgically excised breast tissue. Measured by percentage of positive-staining nuclei with a minimum of 0% to a maximum of 100%. A mean score is determined.|baseline and between 8-23 days|No Ki67 levels were determined. This clinical trial was closed due to slow accrual|||percentage of stained cell nuclei||Standard Deviation|Mean
1433567|NCT00984334|Primary|Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing.|Incidence and severity of treatment emergent adverse events on single dosing.|3 weeks|Intent to treat.|||participants|||Number
1433568|NCT00984308|Secondary|Sleep Apnea Treatment Rate||One year|Among the 58 intervention patients with a diagnosis of sleep apnea, CPAP data were available for 57. Among the 7 control patients who received polysomnography as part of usual care, 5 had sleep apnea: CPAP data were available for 4 patients (2 did not receive any CPAP and 2 had CPAP therapy), the data card was unavailable for 1 patient.|||participants|||Number
1433569|NCT00984308|Primary|Hypertension Control|Medication-Adjusted Systolic Blood Pressure|One year|ITT|||mm Hg||Standard Deviation|Mean
1433570|NCT00984308|Primary|Sleep Apnea Diagnosis Rate|The number of patients with a diagnosis of sleep apnea|The entire study period (baseline and up to one-year)|The intervention patients had polysomnography at baseline (n=102) whereas control patients either had polysomnography as part of usual care (n=7) or at the end of the study as part of the study protocol (n=85). The n=7 patients who had polysomnography as part of usual care were included in the analysis for this outcome.|||participants|||Number
1433571|NCT00984295|Primary|Antibody Response to Tetanus at 6 Weeks Postvaccination – GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
1433572|NCT00984295|Primary|Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT|Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
1446887|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
1433573|NCT00984295|Primary|Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
1433574|NCT00984295|Primary|Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||units/mL||95% Confidence Interval|Geometric Mean
1433575|NCT00984295|Primary|Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||units/mL||95% Confidence Interval|Geometric Mean
1433576|NCT00984295|Primary|Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
1433577|NCT00984295|Primary|Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
1433578|NCT00984295|Primary|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT|Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
1433579|NCT00984295|Primary|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT|Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||ELISA Ab units/mL||95% Confidence Interval|Geometric Mean
1433580|NCT00984295|Primary|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)|Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
1433581|NCT00984295|Primary|Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL|Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1433582|NCT00984295|Primary|Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL|Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1433583|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer|Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1433584|NCT00984295|Primary|Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer|Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1433585|NCT00984295|Primary|Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL|Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1433586|NCT00984295|Primary|Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL|Antibody response to Diphtheria at 6 weeks postvaccination|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.|||Participants|||Number
1433730|NCT00983385|Secondary|Participant's Satisfaction With Previous Analgesic Treatment at Baseline|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor.|Baseline||||participants|||Number
1433587|NCT00984295|Primary|Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL|Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline|6 weeks Postvaccination|"The per-protocol analysis set included participants~who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to~varicella at baseline, and followed protocol procedures."|||Participants|||Number
1433588|NCT00984295|Primary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
1433589|NCT00984295|Primary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline|6 weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
1433590|NCT00984295|Primary|Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline|6 Weeks Postvaccination|The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
1433591|NCT00984282|Secondary|AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)|Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration.|A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)|Pharmacokinetic (PK) analysis set=participants with PK data collected after 14 days of uninterrupted and unmodified dosing of sorafenib. If an interruption occurred within 14 days prior to the sample, no doses may be missed for 3 days prior to the sample, and no more than 3 doses could be missed 4 to 14 days prior to the sample collection date.|||mg*h/L||Standard Deviation|Geometric Mean
1433592|NCT00984282|Secondary|Maximum Percent Reduction in Target Lesion Size Based on Central Assessment|The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS|||Percentage of participants|||Number
1433593|NCT00984282|Secondary|Duration of Response (DOR) Based on Central Assessment|Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS - responders only|||Days||Full Range|Median
1433594|NCT00984282|Secondary|Response Rate Based on Central Assessment|Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|PPS|||Percentage of participants||95% Confidence Interval|Number
1433595|NCT00984282|Secondary|Disease Control Rate (DCR) Based on Central Assessment|Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
1433596|NCT00984282|Secondary|Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation])|From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years|FAS|||Days||95% Confidence Interval|Median
1433597|NCT00984282|Secondary|Overall Survival (OS)|Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.|From randomization of the first subject until the database cut-off (14 Jul 2015), study duration approximately six years|Full Analysis Set (FAS)|||Percentage of participants|||Number
1433609|NCT00984139|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)|The analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
1433598|NCT00984282|Primary|Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation|PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.|Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years|Full Analysis Set (FAS). The primary population for efficacy analysis was the FAS. The FAS was identical to the intent-to-treat (ITT) population, which was defined as all randomized participants. Participants were analyzed as randomized.|||Days||95% Confidence Interval|Median
1433599|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of Area Under the Curve|Plasma concentrations were used to determine the pharmacokinetic curves with determinations of area under the curve (AUC).The smallest AUC Day 0-6.5 associated with protection from detectable parasitemia, and the highest AUC Day 0-6.5 observed in any cases of malaria (prophylactic failures) were to be reported.|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Analysis was done on subjects who completed the study according to protocol|||ng*day/ml||Standard Deviation|Mean
1433600|NCT00984256|Secondary|Measured Concentrations of Plasma Atovaquone With Determinations of T1/2.|Plasma concentrations (ng/ml) were used to determine the elimination half life (t1/2) of atovaquone (days).|7, 6, 5, and 1 day prior to challenge; on the day of the challenge; 1, 4, 5, 6, 7, 8, 10and 14 days after the challenge; and on the day parasitemia develops.,|Population for analysis included According to Protocol Population.|||Days||Standard Deviation|Mean
1433601|NCT00984256|Primary|Prophylactic Efficacy of 3 Different Doses of Atovaquone/Proguanil (Malarone@) Given 1 Week Before Infectious Sporozoite Challenge Using the P. Falciparum Human Challenge Model.|Number of participants with prophylactic efficacy was determined by the absence of cases of malaria parasitemia, defined as microscopically detectable parasitemia by Giemsa-stained thick smears, in those receiving any dose of Malarone as compared to the control (no treatment) group|Days 6-20|"Analysis population was According to Protocol which included participants meeting all eligibility criteria, not meeting any elimination criteria, complying with defined protocol procedures and for whom data are available."|||participants with negative parasitemia|||Number
1433602|NCT00984204|Secondary|Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure||3 months||||participants|||Number
1433603|NCT00984204|Primary|Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.||30 mins||||participants|||Number
1433604|NCT00984204|Primary|Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.||7 days||||participants|||Number
1433605|NCT00984165|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 36 months.||||Participants|||Count of Participants
1433606|NCT00984165|Primary|Response to Graft Versus Host Disease (GVHD) Treatment|The following criteria is used to determine response to GVHD treatment. Complete response (CR) is complete resolution of all clinical signs and symptoms of acute GVHD. Partial response (PR) is 50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score >/= 70%). Non-responder (NR) <50% reduction in skin rash, stool volume or frequency, and/or total bilirubin. Failure to maintain adequate performance status (Karnofsky Score </= 70%). Progressive disease (PD) is further progression of signs and symptoms of acute GVHD, and/or decline in performance status after the initiation of therapy.|Up to 100 days|"No results were collected on the Donor Lymphocyte Infusion-Donor Arm. This arm allowed for collection of the lymphocytes on healthy donors for infusion on the DLI/Radiation Arm or the DLI/Control Group."|||participants|||Number
1433607|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
1433608|NCT00984139|Secondary|Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.|Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
1433610|NCT00984139|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
1433611|NCT00984139|Secondary|Number of Subjects With Solicited Local and General Symptoms|"Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.~Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius."|During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination|The analysis was performed on the Total Vaccinated cohort.|||Participants|||Count of Participants
1433612|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values|The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
1433613|NCT00984139|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values|"The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.~Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure."|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
1433614|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
1433615|NCT00984139|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of Engerix-B and for whom data concerning immunogenicity outcome measures were available at the time point after the Engerix-B challenge dose.|||Participants|||Count of Participants
1433616|NCT00984126|Secondary|Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds.|Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds using a four-point response scale: none, moderate, good or excellent. The evaluation was done by patient, caregiver and/or investigator based on experience as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than 1 infusion for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first infusion; usually requiring more than 1 infusion. 4. None: No improvement, or worsening of symptoms. This endpoint is measured during the preventive and on-demand sub-trial (during 90 months).|After 90 months|Full Aanalysis Set. The endpoint was measured for preventive and on-demand regimen for comparison of the efficacy of turoctocog alfa between regimens. Number of subjects analysed=subjects who received preventive and on-demand regimen and were evaluable for this outcome.|||Number of bleeds|||Number
1433617|NCT00984126|Secondary|Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen)|The number of bleeding episodes per year reported during the prevention period (during 90 months).|After 90 months|Full Analysis Set. Number of subjects analysed=Subjects who received preventive regimen and were evaluable for the outcome.|||Bleeding episodes/year||Full Range|Median
1433618|NCT00984126|Secondary|Frequency of Adverse Events and Serious Adverse Events|The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months).|After 90 months|Safety Analysis Set includes all dosed subjects with data after dosing.|||Number of Events|||Number
1433619|NCT00984126|Primary|Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL)|The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial. This endpoint was measured during the trial.|After 90 months|Full analysis set|||subjects|||Number
1433620|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration||||ng-hr/mL||Standard Deviation|Mean
1433621|NCT00984061|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|serial pharmacokinetic blood samples collected immediately prior to dosing on Days 1 and 29, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours after dose administration||||ng-hr/mL||Standard Deviation|Mean
1433626|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433627|NCT00984009|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433628|NCT00984009|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
1433629|NCT00983983|Primary|Tolerability|Number of participants who completed the study on their assigned study intervention.|5 months|The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention).|||participants|||Number
1433630|NCT00983983|Primary|Serious Adverse Events|SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|5 months||||Number of Serious Adverse Events|||Number
1433631|NCT00983983|Primary|Safety Outcomes: Frequency of Adverse Events||5 months||||Total Number of Adverse Events|||Number
1433632|NCT00983983|Secondary|Biomarkers of Body Composition and Lipid Metabolism||5 months follow-up|||||||
1433633|NCT00983983|Secondary|Rate of Change in ALSFRS-R in Units/Month|Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.|Over 5 months||||units on a scale/month||95% Confidence Interval|Mean
1433634|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||hours||Full Range|Median
1433635|NCT00983957|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin|Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in nanograms multiplied by hours (h) per milliliter (ng*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1433636|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters|The electrocardiogram (ECG) evaluations were performed within ± 15 minutes of the relative time points. ECGs were recorded after the participants were in supine position for at least 5 minutes. ECG parameters measured were: PR interval, QRS complex, QT interval and corrected QT (QTc).|Screening, Day 1, Day 67, Day 77|All participants who received at least one dose of study drug.|||participants|||Number
1433637|NCT00983957|Secondary|Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs|Vital Signs were measured after the participant was seated quietly for at least 5 minutes and included systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature. Baseline = Last non-missing pretreatment value.|Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge|All participants who received at least one dose of study drug.|||participants|||Number
1433638|NCT00983957|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory marked abnormalities were defined as Hematocrit (low) as <0.85*Pre-treatment (PreRx), Hemoglobin (low) as <0.85*PreRx, Aspartate Aminotransferase (AST) (high) as >1.25*PreRx if PreRx > upper limits of normal (ULN); >1.25*ULN if PreRx <=ULN; >1.25*ULN if PreRx = Missing, Blood in urine (high) as ≥2 PreRx if PreRx ≥1; ≥2 if PreRx <1; ≥2 if PreRx = Missing.|From start of treatment (Day 1) up to Day 78 or discharge|All participants who received at least one dose of study drug.|||participants|||Number
1433639|NCT00983957|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug|All participants who received at least one dose of study drug.|||participants|||Number
1433640|NCT00983957|Primary|Maximum Observed Plasma Concentration of Norelgestromin|Norelgestromin is a major active metabolite of norgestimate (NGM) which is found in Ortho Tri-Cyclen. Norelgestromin was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1446888|NCT00877929|Secondary|BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
1433641|NCT00983957|Primary|Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug|||hours||Full Range|Median
1433642|NCT00983957|Secondary|Time of Maximum Observed Plasma Concentration of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. Tmax was measured in hours (h), and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||hours||Full Range|Median
1433643|NCT00983957|Secondary|Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel|Norgestrel was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1433644|NCT00983957|Primary|Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol|Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry by a validated analytical method during the period of known analyte stability. AUC(TAU) was measured in picograms multiplied by hours (h) per milliliter (pg*h/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1433645|NCT00983957|Secondary|Maximum Observed Plasma Concentration of Norgestrel|Norgestrel is an NGM metabolite and was measured in plasma using liquid chromatography–mass spectrometry by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77|All participants who received the study drug.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1433646|NCT00983957|Primary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol|Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the lower limit of quantitation were treated as missing.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77|All participants who received the study drug.|||picogram per millilitre (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1433647|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433648|NCT00983931|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433649|NCT00983931|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 15, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
1433650|NCT00983918|Secondary|Analgesic Consumption||24 hours|||||||
1433651|NCT00983918|Primary|Pain Measured on Verbal Scale of 0-10|Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.|24 hours||||units on a scale||Standard Deviation|Mean
1433652|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the theophylline plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable theophylline plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration||||µg-hr/mL||Standard Deviation|Mean
1433731|NCT00983385|Secondary|Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.|Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial.|Week 6|Negative painDETECT subpopulation - 22 participants Unclear painDETECT subpopulation - 15 participants Positive painDETECT subpopulation - 22 participants Intention to treat (ITT).|||milligrams (mg)||Standard Deviation|Mean
1433653|NCT00983905|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the theophylline plasma concentration versus time curve, from time 0 to the time of the last measurable theophylline concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration||||µg-hr/mL||Standard Deviation|Mean
1433654|NCT00983905|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that theophylline drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to theophylline dosing (0 hour) on Days 1 and 19, then at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after theophylline dose administration||||µg/mL||Standard Deviation|Mean
1433655|NCT00983892|Primary|Summed Symptom Severity|Summed severity across 8 symptoms of interest, as measured using the MD Anderson Symptom Inventory. 8 core symptoms rated by the patient on a scale of 0 to 10. These 8 symptoms were chosen based on their prevalence of 50% or greater in the population of interest. Higher scores mean WORSE or GREATER SYMPTOM BURDEN.|3 months||||units on a scale||Standard Deviation|Mean
1433656|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Atazanavir (ATZ), Ritonavir, and Tenofovir (Part B Only, Subjects on ATV-based HAART)|Ctrough of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data|||ratio (test/reference)||Full Range|Median
1433657|NCT00983853|Secondary|Median Trough Plasma Concentration (Ctrough) Ratios of Efavirenz and Tenofovir (Part B Only, Subjects on EFV-based HAART)|Ctrough ratio of HAART medication with telaprevir (test) and without telaprevir (reference)|through 12 weeks after first dose of study drug|subjects with available concentration data|||ratio (test/reference)||Full Range|Median
1433658|NCT00983853|Secondary|Effect of Efavirenz-based (EFV) and Atazanavir-based (ATV/r) Highly Active Antiretroviral Therapy(HAART) on Telaprevir Exposure||through 12 weeks after first dose of study drug|subjects with available plasma concentration data|||ratio (test/reference)||90% Confidence Interval|Least Squares Mean
1433659|NCT00983853|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks (SVR12) and 24 Weeks (SVR24) After Last Planned Dose of Study Treatment||12 weeks after last dose of study drug|subjects who received at least 1 dose of study drug.|||participants|||Number
1433660|NCT00983853|Secondary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 4 and Week 12|number of subjects with undetectable HCV RNA|4 and 12 weeks after the first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug|||participants|||Number
1433661|NCT00983853|Primary|Proportion of Subjects Achieving Undetectable HCV RNA at Week 12||12 weeks after first dose of study drug|Subjects who were randomized and received at least 1 dose of study drug|||participants|||Number
1433662|NCT00983827|Primary|Safety|Number of procedure related adverse events that occurred during study.|16 weeks||||adverse events|||Number
1433663|NCT00983801|Secondary|Number of Participants With Serum Chemistry Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=>ULN-2.5*ULN; GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4=>20.0*ULN. Total bilirubin: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN. Creatinine: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. ULN=upper limit of normal.|Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone. n=number of participants with at least 1 measurement available during the study therapy period.|||participants|||Number
1433664|NCT00983801|Secondary|Number of Participants With Hematology Abnormalities|Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=<LLN-3.0*10^9/L; GR2=<3.0-2.0*10^9/L; GR3=<2.0-1.0*10^9/L; GR4=<1.0*10^9/L. Absolute Neutrophil Count (ANC):GR1=<LLN-1.5*10^9 /L; GR2=<1.5-1.0*10^9/L; GR3=<1.0-0.5*10^9/L; GR4=<0.5*10^9/L. Platelets:GR1=<LLN-75.0*10^9/L; GR2=<75.0-50.0*10^9/L; GR3=<50.0-25.0*10^9/L, GR4=<25.0*10^9/L. Hemoglobin:GR1=<LLN-10.0g/dL; GR2=<10.0-8.0g/dL; GR3=<8.0-6.5g/dL, GR4=<6.5g/dL. LLN=lower limit of normal.|Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks).|Participants who received at least 1 dose of ixabepilone and had at least one measurement available during the study therapy period.|||participants|||Number
1433665|NCT00983801|Other Pre-specified|Number of Participants With Best Response as Assessed With Modified RECIST|Best overall response that any participant can have is the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. PR criteria should be met again after 4 weeks and before 6 weeks. Stable disease (SD)=Neither PR or progressive disease (PD) are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 4 for definition of PD.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).|||participants|||Number
1433673|NCT00983749|Primary|Feasibility and Tolerability of External Counterpulsation|The first primary outcome measure was tolerability and feasibility. Tolerance was defined as the absence of any indications to stop the procedure or reduce the pressure to a non-therapeutic level. Feasibility was defined in the full-pressure group as the sustained (at least 30 minutes) tolerance of any pressure capable of causing a 15% augmentation of MFV in 90% of subjects, and defined in the sham-pressure group as the sustained tolerance of the sham pressure in all subjects.|During one hour of treatment||||participants|||Number
1433674|NCT00983645|Secondary|Lipid Levels||6 months post-transplant|Data cannot be located for analysis.||||||
1433675|NCT00983645|Secondary|Post-transplant Diabetes Mellitus||6 months post-transplant|Data cannot be located for analysis.||||||
1433666|NCT00983801|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0|AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. DR=Drug-related. Any Peripheral Neuropathy includes peripheral sensory and motor neuropathies, including muscle weakness, and hypoaesthesia.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks)|Participants who received at least 1 dose of study therapy.|||participants|||Number
1433667|NCT00983801|Secondary|Percentage of Participants With Disease Control Rate|Defined as percentage of participants whose best response was PR, CR, or SD as determined by the investigator. SD=Neither PR or PD are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 1 for definition of CR or PR and refer to outcome measure 4 for definition of PD. A 2-sided 95% CI was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).|||percentage of participants||95% Confidence Interval|Number
1433668|NCT00983801|Secondary|Progression Free Survival (PFS)|PFS=the time interval from date of randomization to the earliest (first) progression or date of death. Participants who progressed or died were counted as events. PD=≥20% increase in sum of LD of target lesions and an absolute increase ≥5 mm in tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated using the Kaplan-Meier product-limit method for all treated participants and a 2-sided 95% CI for the median PFS was computed by Brookmeyer and Crowley method).|From the date of initiation of study therapy to the date of progression (up to 8.1 months).|Participants who received at least 1 dose of ixabepilone. Participants who died without reporting prior progression were considered to have progressed on their death day. Participants who did not progress or die were censored on their last tumor assessment day. Participants without on-study tumor assessments were censored at start date of therapy.|||months||95% Confidence Interval|Median
1433669|NCT00983801|Secondary|Duration of Response|Defined as the period in months from the time measurement criteria are first met for PR or CR until the first date of documented PD or death. Refer to outcome measure 1 for CR and PR. PD=≥20% increase in the sum of LD of target lesions and an absolute increase of at least 5 mm of tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated by Kaplan-Meier product limit method and a 2-sided 95% CI for median duration was computed by Brookmeyer and Crowley method.|From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)|Participants who received at least 1 dose of ixabepilone and had either CR or PR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment.|||months||95% Confidence Interval|Median
1433670|NCT00983801|Secondary|Time to Response|Time to response is defined as the time in weeks from the first dose of study therapy until measurement criteria are first met for PR or CR (whichever status is recorded first). CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node lesions, the short axis of all nodes should measure <10 mm. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks of initial assessment.|Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)|Participants who received at least 1 dose of study therapy and had a response of either CR or PR.|||weeks||Full Range|Median
1433671|NCT00983801|Primary|Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring <10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.|During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)|Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).|||percentage of participants||95% Confidence Interval|Number
1433672|NCT00983749|Primary|Safety (Including Endpoints Such an Increase NIHSS During or Immediately After ECP, and Acute Hemorrhage on Repeating Imaging, Serious Adverse Events Related to ECP, Mortality)|Safety was evaluated by the incidence of serious adverse events (SAEs) or acute neurological deterioration in relation to the study device and/or procedures at 30 days, the incidence of acute symptomatic hemorrhage on repeat imaging at 24 hours, the incidence of all adverse events (AEs) in the first 48 hours, and mortality at 30 days. The National Institutes of Health Stroke Scale (NIHSS) is a stroke severity scale, based on examination, that goes from 0 (no deficit) to a maximum of 42. Acute neurological deterioration – which was captured as a serious adverse event - was defined as a ≥4-point increase on the NIHSS, or a ≥2-point decline in level of consciousness item 1a on the NIHSS, or a new neurological deficit, or clinically significant worsening of motor function lasting more than 8 hours and attributable to a neurological entity. Symptomatic intracranial hemorrhage was defined as new hemorrhage on CT that was associated with acute neurological deterioration.|30 days||||participants|||Number
1433679|NCT00983580|Other Pre-specified|Effect of the Study Drugs and Placebo With Respect to Biomarkers|For continuous variables, we will use the 2-sample t-test (or nonparametric equivalent) to compare the active arm to the placebo arm. For categorical data, we will explore the relationship between the treatment arms and biomarkers with chi-square or fisher's exact tests. Correlations will be sought between caspase-3 staining, proliferative indices and their ratio, as well as other biomarkers using a chi-square test.|Baseline and 12 months|Data were not collected for this endpoint.||||||
1433680|NCT00983580|Secondary|Safety, Tolerability, and Adverse Events of Study Treatment|The National Cancer Institute (NCI) Common Terminology Criteria (CTC) Version 3.0 was used to grade all adverse events. The number of patients reporting a grade 3 or higher event are tabulated here. A grade 3 event is one categorized as being severe or medically significant but not immediately life-threatening. A grade 4 is considered life-threatening, and a grade 5 is death related to the event. A complete list of all adverse events is given in the Adverse Events section.|Up to 48 months from beginning treatment.|On Arm 1, 1 patient cancelled prior to treatment, 1 was a violation, 3 were deemed ineligible. On Arm 2, 3 were ineligible, 1 was a violation. All other patients were treated and evaluated for toxicity and included in this evaluation.|||Participants|||Count of Participants
1433681|NCT00983580|Secondary|Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms|The number of ACF sites per patient was collected at baseline and at 1-year time points. The percent change in ACF number was calculated as the number of ACF present at the 12-month post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites from baseline to year 1 post-treatment. A positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. The percent change in ACF number between arms was compared using a t-test.|At baseline and 12 months|All eligible treated patients that were assessed for ACF at baseline and after 1-year of treatment were included in this analysis.|||percentage of change in ACF number||Standard Deviation|Mean
1433682|NCT00983580|Secondary|Characterization of ACF|A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. The number and total size of ACF sites may serve as risk markers for adenoma/carcinoma development. The median number of ACF sites per patient were collected prior to treatment.|Baseline|Of the 49 eligible patients receiving treatment in Arm I, 2 patients did not have ACF analysis done. The same number of patients of patients did not have ACF done in Arm II.|||number of ACF sites||Full Range|Median
1433683|NCT00983580|Secondary|ACF Characteristics vs Adenoma Recurrence Rate|A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. At the 1-year time point, the presence of adenoma recurrence and the number of ACF sites was recorded for each patient. The percent change in ACF number was calculated as the number of ACF present at the 1-year post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites and a positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. A Wilcoxon Rank-sum test was used to assess the relationship between ACF percent change and adenoma recurrence rate. This analysis was only conducted in those participants who had at least 5 rectal ACF at baseline.|At baseline and 1 year|All patients that were eligible, treated, analyzed for ACF at baseline and 12-months, and had 5 or more ACF at baseline were included in this analysis.|||percentage of change in ACF number||Full Range|Median
1433684|NCT00983580|Primary|Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo|The primary endpoint is the proportion of participants with an adenoma recurrence at the 1-year follow-up colonoscopy exam. All eligible, randomized participants who have signed a consent form and received at least one follow-up endoscopy exam will be considered evaluable for the primary endpoint. This adenoma recurrence rate for DFMO + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population. A 1-sided Chi-square test was used to determine if there was a significant difference between treatment arms.|At 1 year|On Arm 1, 1 patient cancelled prior to treatment, 1 was a violation, 3 were deemed ineligible, and 7 patients did not receive a follow-up endoscopy. On Arm 2, 3 patients cancelled prior to treatment, 1 was a violation, and 6 did not receive a follow-up endoscopy.|||proportion of participants|||Number
1433685|NCT00983541|Secondary|Evaluate Rate of Distant Mets Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
1433686|NCT00983541|Secondary|Evaluate Local Control Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
1433687|NCT00983541|Secondary|Evaluate Tumor Response Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months.|Trial did not meet accrual goals so analysis was not performed||||||
1433688|NCT00983541|Secondary|Evaluate Progression Free Survival Rate Following Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
1433689|NCT00983541|Secondary|Evaluate the Rate at Which Patients With Unresectable Extrahepatic Cholangiocarcinoma Become Resectable Following Gemcitabine and Radiation Therapy.||9 months|Trial did not meet accrual goals so analysis was not performed||||||
1433690|NCT00983541|Secondary|Evaluate Overall Survival Ratefollowing Gemcitabine and 5-FU With Radiation Therapy in Patients With HCC||9 months|Trial did not meet accrual goals so analysis was not performed||||||
1433691|NCT00983541|Primary|Number of Participants Experiencing Toxicity Treated With Gemcitabine Every Two Weeks & 5-FU Given Concurrently With External Beam Radiation Therapy , Followed by Brachytherapy or SBRT Boost.||Toxicity was assessed for each patient over the course of the study treatment and follow-up stage which together lasted 9 months. Only one patient was enrolled.||||participants|||Number
1433754|NCT00983385|Secondary|Patient Global Impression of Change at End of the Maintenance Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).|||participants|||Number
1433692|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433693|NCT00983515|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433694|NCT00983515|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
1433695|NCT00983489|Primary|Exclusive Breast Feeding Rate at Six Weeks Postnatal Age||6 weeks||||Participants|||Number
1433696|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|12 months|All randomized participants who received the intervention as randomized and who completed a 12 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||kg/meter square||Standard Deviation|Mean
1433697|NCT00983476|Secondary|BMI|BMI = (weight in pounds * 703)/ height in inches²|9 months|All randomized participants who received the intervention as randomized and who completed a 9 month follow-up weight were included in this summary. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||kg/meter squared||Standard Deviation|Mean
1433698|NCT00983476|Secondary|Quality of Life: Sexual Life|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al 2008): Sexual Life subscale.~The Sexual Life subscale includes survey items 19-22, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
1433699|NCT00983476|Secondary|Quality of Life: Self-Esteem|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al. 2008): Self-Esteem subscale.~The Self-Esteem subscale includes survey items 12-18, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and had data at 6 months were included in the analyses. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
1433700|NCT00983476|Secondary|Quality of Life: Physical Functioning|"Impact of Weight on Quality of Life (IWQOL; Kolotkin et al., 2008): Physical Functioning subscale.~The Physical Functioning subscale includes survey items 1-11, which are each scored on a scale from 1-5. The subscale score is an average of the scores on those items. Lower scores indicate greater impairment. Range in the subscale scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
1433701|NCT00983476|Primary|Dietary Habits: Reducing Fat (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Fat Factor.~The Reducing Fat factor includes survey items 16-20, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing fat in the diet. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
1433702|NCT00983476|Primary|Dietary Habits: Reducing Calories (Self-efficacy, Motivation, Readiness to Change)|"Self-Efficacy and Eating Habits Survey (Sallis et al., 1988): Reducing Calories Factor.~The Reducing Calories factor includes survey items 6-10, which are each scored on a scale from 1-5. The factor score is an average of the scores on those items. Higher scores indicate more confidence in making the change in reducing calories. Range in the factor scores can be from 1 (min) to 5 (max)."|6 months|All randomized participants who received the intervention as randomized and completed this measure at 6 months were included in the analysis. Receiving the intervention as randomized was minimally defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||units on a scale||Standard Error|Mean
1433703|NCT00983476|Primary|Body Mass Index (BMI) Within Obese Sample|BMI = (weight in pounds * 703)/ (height in inches²); obese defined as BMI > 30|6 months|Analyses excluded participants with BMI of 28-29.9 (overweight) at baseline, leaving only those with BMI >= 30 at baseline who received the intervention as randomized.|||kilogram/(meters squared)||Standard Error|Mean
1433755|NCT00983385|Secondary|Patient Global Impression of Change at End of Titration and Optimal Dose Period|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).|||participants|||Number
1433704|NCT00983476|Primary|Body Mass Index (BMI)|BMI = (weight in pounds * 703)/ (height in inches²) at 6 month follow-up as predicted by the mixed model described in Statistical Analysis 1|6 months|All randomized participants who received any intervention as randomized were included in the primary analyses, regardless of the number of assessments completed. Receiving intervention as randomized was defined as participating in one or more modules/sessions (WebMOVE or MOVE SMI) or receipt of the educational handout (Usual Care).|||kg/(meters squared)||Standard Error|Mean
1433705|NCT00983437|Secondary|Change From Baseline in the Medical Outcomes Study 6-Item Cognitive Functioning Scale (MOS-CF6) Total Score at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The MOS-CF 6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6-item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 is scored by summing responses across the 6 items and converting the total to a 0- to 100-point scale, with higher scores indicating better cognitive functioning. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Months 3, 6, 9, and 12 (or last postbaseline observation)|Changes from baseline in MOS-CF6 total score were not summarized. This assessment was not performed in study C10953/3067/ES/MN (NCT00893789); therefore, the data obtained at screening for the current study would represent true baseline data only for new participants, of which there were none.||||||
1433706|NCT00983437|Primary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set with a Baseline value; n=number of participants with baseline and postbaseline value at given time point.|||units on a scale||Standard Deviation|Mean
1433707|NCT00983437|Primary|"Number of Participants Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or Last Postbaseline Observation)"|The percentage of participants answering 'yes' to any of the 9 yes/no questions about suicidal behaviors, ideations, and acts at given time points are presented. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). Questions included the presence (yes) or absence (no) of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Week 2, Months 1, 2, 3, 6, 9, and Endpoint (Month 12, or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; n=number of participants with nonmissing value at given time point.|||participants|||Number
1433708|NCT00983437|Primary|Safety and Tolerability: Physical Examination Findings Shifts From Baseline to Endpoint (Month 12 or Last Postbaseline Observation)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT= head, eyes, ears, nose, throat. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint physical examination findings are summarized.|||participants|||Number
1433709|NCT00983437|Primary|Safety and Tolerability: Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline through Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; only those participants with both baseline and endpoint ECG findings are summarized.|||participants|||Number
1433710|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure ≥90 mm Hg plus increase of ≥10% from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set; participants with a baseline and postbaseline value.|||participants|||Number
1447221|NCT00874250|Secondary|Procedure Time (Minutes)|Total time in minutes required for surgical device implantation.|Initial Device Implant Procedure During Index Hospitalization||||Minutes||95% Confidence Interval|Median
1433711|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Urinalysis Results|Criteria for clinically significant abnormal urinalysis values: blood (hemoglobin) ≥2 unit increase from baseline; glucose ≥2 unit increase from baseline; ketones ≥2 unit increase from baseline; total protein ≥2 unit increase from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
1433712|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Hematology Test Results|Criteria for clinically significant abnormal hematology values: hematocrit, men <0.37 L/L or women <0.32 L/L; hemoglobin, men ≤115 g/L or women ≤95 g/L; white blood cell (WBC) count ≤3x10^9/L or ≥20x10^9/L; eosinophils ≥10%; absolute neutrophil count (ANC) ≤1x10^9/L; platelet count ≤75x10^9/L or ≥700x10^9/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
1433713|NCT00983437|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Score Values at Months 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|"The TBI-WIS is a validated participant-rated instrument for assessing a participant's functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a true or not true answer. To score the questionnaire, the number of true responses is counted: if < 2, the risk for work instability is low; 2 to 23, the risk is medium; and >23, the risk is high. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability). Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study."|Baseline, Months 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Full Analysis Set (those in the Safety Analysis Set with at least 1 post-baseline efficacy assessment) with a TBI-WIS score at baseline; n=number of participants with value at baseline and given time point.|||units on a scale||Standard Deviation|Mean
1433714|NCT00983437|Secondary|Percentage of Participants With Improvement on the Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Improvement is defined as at least 1 point improvement from baseline. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.|||percentage of participants|||Number
1433715|NCT00983437|Secondary|Change From Baseline in Clinical Global Impression of Severity of Illness (CGI-S) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The clinician's rating of disease severity as assessed by the Clinical Global Impression of Severity (CGI-S). CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill); the 7 categories include the following: normal-shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.|||units on a scale||Standard Deviation|Mean
1433716|NCT00983437|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or Last Postbaseline Observation)|The participant's evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient's propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2 and Months 1, 2, 3, 6, 9, and Endpoint (Month 12 or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Full Analysis Set = participants in the Safety Analysis Set who had at least 1 post-baseline efficacy assessment; n=number of participants with value at baseline and given time point.|||units on a scale||Standard Deviation|Mean
1433717|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Abnormal Vital Signs Measurements|Criteria for clinically significant abnormal vital signs values: pulse, ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm or ≤50 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure, ≥180 mm Hg and increase from baseline of ≥20 mm Hg or ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; diastolic blood pressure, ≥105 mm Hg and increase from baseline of ≥15 mm Hg or ≤50 mm Hg and decrease from baseline of ≥15 mm Hg; temperature >38.3º celsius (C) and change from baseline of ≥1.1°C. Baseline was defined as the baseline value from the double-blind study C10953/3067/ES/MN (NCT00893789) from which the participants entered into this open-label study.|Baseline, Week 2, Months 1, 2, 3, 6, 9, and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
1441666|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
1433718|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Clinically Significant Serum Chemistry Test Results|Criteria for clinically significant abnormal serum chemistry values: alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN); aspartate aminotransferase (AST) ≥3x ULN; alkaline phosphatase ≥3x ULN; gamma-glutamyl transpeptidase (GGT) ≥3x ULN; lactate dehydrogenase (LDH) ≥3x ULN; blood urea nitrogen (BUN) ≥10.71 mmol/L; creatinine ≥177 μmol/L; uric acid, men ≥625 μmol/L, women ≥506 μmol/L; bilirubin (total) ≥34.2 μmol/L.|Assessed at Screening, Months 6 and 12 (or last postbaseline observation); median (full range) of treatment was 98 (5.0 to 326.0) days.|Participants in the Safety Analysis Set who had a baseline and at least one post-baseline value.|||participants|||Number
1433719|NCT00983437|Primary|Safety and Tolerability: Concomitant Medication Usage In Participants Throughout the Study|Therapeutic classification of concomitant medications used by participants throughout the study. Participants are counted only once in each therapeutic class category.|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set|||participants|||Number
1433720|NCT00983437|Primary|Safety and Tolerability: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs|AE=any untoward medical occurrence that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship to study drug. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis, and seizure or suspected seizure were considered to be of potential clinical importance. DB=double-blind portion of the study (NCT00893789).|Assessed from Screening through end of treatment; median (full range) of treatment was 98 (5.0 to 326.0) days.|Safety Analysis Set (study participants who received at least 1 dose of study drug)|||participants|||Number
1433721|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 8 participants. Unclear and positive painDETECT subpopulation - 42 participants|||Units on a scale||Standard Deviation|Mean
1433722|NCT00983385|Secondary|NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 13 participants. Unclear and positive painDETECT subpopulation - 62 participants|||Units on a scale||Standard Deviation|Mean
1433723|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 18 participants. Unclear and positive painDETECT subpopulation - 70 participants|||Units on a scale||Standard Deviation|Mean
1433724|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 12|Intention to treat (ITT). Negative painDETECT subpopulation - 15 participants. Unclear and positive painDETECT subpopulation - 24 participants|||Units on a scale||Standard Deviation|Mean
1433725|NCT00983385|Secondary|NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|End of Week 6|Intention to treat (ITT). Negative painDETECT subpopulation - 22 participants. Unclear and positive painDETECT subpopulation - 37 participants|||Units on a scale||Standard Deviation|Mean
1433726|NCT00983385|Secondary|Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to treat (ITT). Negative painDETECT subpopulation - 31 participants. Unclear and positive painDETECT subpopulation - 56 participants|||Units on a scale||Standard Deviation|Mean
1433727|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 12|Intention to treat (ITT).|||participants|||Number
1433728|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 8|Intention to treat (ITT).|||participants|||Number
1433729|NCT00983385|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|End of Week 6|Intention to treat (ITT).|||participants|||Number
1447222|NCT00874250|Secondary|The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.||Treatment through 1 month post procedure||||participants|||Number
1433732|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|"Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants.~Intention to Treat (ITT)."|||units on a scale||Standard Deviation|Mean
1433733|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear or positive painDETEC subpopulation - 94 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
1433734|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Depression Score at Baseline|"Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
1433735|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 12 (12 Weeks)|Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
1433736|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline; End of Week 6 (6 weeks)|Negative painDETECT subpopulation - 34 participants Unclear and positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
1433737|NCT00983385|Secondary|Hospital Anxiety Depression Scale: Anxiety Score at Baseline|"Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.~HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points.~A negative value indicates that there has been an improvement."|Baseline|Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).|||units on a scale||Standard Deviation|Mean
1433738|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Maintenance Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT).|||participants|||Number
1433739|NCT00983385|Secondary|Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT).|||participants|||Number
1433740|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 23 participants. Unclear and positive painDETECT subpopulation - 66 participants.|||Units on a scale||Standard Deviation|Mean
1433741|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 weeks)|Intention to treat (ITT). Unclear and positive painDETECT subpopulation - 66 participants. painDETECT negative subpopulation - 23 participants.|||units on a scale||Standard Deviation|Mean
1433786|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||Participants|||Number
1433742|NCT00983385|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 34 participants. Unclear and positive painDETECT subpopulation - 97 participants.|||Units on a scale||Standard Deviation|Mean
1433743|NCT00983385|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT). painDETECT negative subpopulation - 35 participants. Unclear and positive painDETECT subpopulation - 98 participants.|||Units on a scale||Standard Deviation|Mean
1433744|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1433745|NCT00983385|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period|Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT), Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1433746|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433747|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|End of Week 6|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433748|NCT00983385|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline|Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.|Baseline Visit|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433749|NCT00983385|Secondary|painDETECT Assessment for Participants at End of the Maintenance Period|"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 12|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433750|NCT00983385|Secondary|painDETECT Assessment for Participants at End of Titration and Optimal Dose Period|"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|End of Week 6|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433751|NCT00983385|Secondary|painDETECT Assessment at Baseline|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear."|Baseline|Intention to treat (ITT).|||units on a scale||Standard Deviation|Mean
1433752|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 12 (12 weeks)||||Units on a scale||Standard Deviation|Mean
1433753|NCT00983385|Secondary|Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period|The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.|Baseline; End of Week 6 (6 weeks)|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1433756|NCT00983385|Primary|The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|Baseline; End of Week 6 (6 Weeks)|Intention to treat. Last Observation Carried Forward (LOCF)|||Units on a scale||Standard Deviation|Mean
1433757|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration||||pg-hr/mL||Standard Deviation|Mean
1433758|NCT00983372|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration||||pg-hr/mL||Standard Deviation|Mean
1433759|NCT00983372|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration||||pg/mL||Standard Deviation|Mean
1433760|NCT00983359|Secondary|Karnofsky Decay Time|Time from enrollment to the date the patient’s Karnofsky performance score drops below 60. If the patient dies of any cause with no documentation of a drop in their Karnofsky score to less than 60, the date of death will be used as the date of worsening of the Karnofsky score. A patient with a Karnofsky score of 60 or greater requires occasional assistance, but is able to care for most of his/her needs. A patient’s Karnofsky decay time will be considered censored if the patient is still under follow up with a Karnofsky score of 60 or greater and if the patient dies of a non-cancer-related cause.|From time of enrollment up to 5 years||||months||Full Range|Median
1433761|NCT00983359|Secondary|Time to Systemic Death|Descriptive analysis will be conducted using Kaplan-Meier survival analysis|From time of enrollment up to 5 years||||months||95% Confidence Interval|Median
1433762|NCT00983359|Secondary|Time to Neurological Death|Time from enrollment to date of death directly due to brain metastases. Deaths from other causes including hemorrhage or infection will be considered ‘censored’ observations in the setting of neurologic improvement or stabilization. If the patient dies of any cause with worsening of neurologic symptoms, the death will be counted as an ‘event’ or neurological death.|From time of enrollment up to 5 years||||months||Full Range|Median
1433763|NCT00983359|Secondary|Progression-free Survival (PFS)|Time from enrollment to first date of progressive or recurrent disease. Worsening of neurological symptoms is considered indicative of neurological disease progression. Patients who die of disease-related or treatment-related causes will be considered to have progressed at their date of death; i.e., not be considered ‘censored’. PFS will be considered censored only if no progression is noted or if the patient dies of a clearly non-cancer-related event such as accident.|Up to 5 years||||months||95% Confidence Interval|Median
1433764|NCT00983359|Primary|Proportion of Patients Dying of Neurological Death, Defined as Dying With Progressive Neurological Dysfunction Regardless of Systemic Disease Status|Neurological death is defined as dying with progressive neurological dysfunction regardless of systemic disease status. Patients wtih severe neurological disability who die of intercurrent illness will also be considered to have died of neurological death.|Up to 5 years||||patients|||Number
1433765|NCT00983346|Primary|Bone Anabolic Effect of Bortezomib in Patients With Smoldering Myeloma.|The primary endpoint is the change in bone Alkaline Phosphatase at baseline and 6 weeks.|Baseline and 6 weeks|Only 13 patents had bone alkaline phosphatase measured at the appropriate time points out of the 17 that completed the study|||Percentage of Baseline Value|||Number
1433766|NCT00983307|Primary|Number of Participants That Experience Progression-free Survival.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years||||Participants|||Count of Participants
1433767|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433768|NCT00983294|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433769|NCT00983294|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to colchicine dose administration (0 hour) on Days 1 and 19, then at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
1433770|NCT00983281|Primary|Mortality||Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days.||||participants|||Number
1437501|NCT00953615|Secondary|Mayo Risk Score|The Mayo Risk Score estimates the survival probability of a patient with primary sclerosing cholangitis based on the following variables: age, bilirubin, albumin, AST and history of variceal bleeding.|6 months||||units on a scale|||Number
1433771|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.||||pg-hr/mL||Standard Deviation|Mean
1433772|NCT00983242|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable colchicine concentration (time t), as calculated by the linear trapezoidal method.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.||||pg-hr/mL||Standard Deviation|Mean
1433773|NCT00983242|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|On Days 1 and 19 - serial pharmacokinetic blood samples were collected pre-dose and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.||||pg/mL||Standard Deviation|Mean
1433774|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the colchicine plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433775|NCT00983216|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the colchicine plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration||||pg-hr/mL||Standard Deviation|Mean
1433776|NCT00983216|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn within 1 hour prior to colchicine dosing (0 hour) on Days 1 and 19, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 and 96 hours after colchicine dose administration||||pg/mL||Standard Deviation|Mean
1433777|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||units on a scale||Standard Deviation|Mean
1433778|NCT00983073|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||units on a scale||Standard Deviation|Mean
1433779|NCT00983073|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Number of participants with data available|||units on a scale||Standard Deviation|Mean
1433780|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||participants|||Number
1433781|NCT00983073|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||participants|||Number
1433782|NCT00983073|Secondary|Participant's Satisfaction With Previous Analgesic Treatment|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Number of participants with data available.|||participants|||Number
1433783|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||Participants|||Number
1433784|NCT00983073|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available|||Participants|||Number
1433785|NCT00983073|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||Participants|||Number
1433787|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline, End of Week 12 (12 Weeks)|Number of participants with data available|||Units on a scale||Standard Deviation|Mean
1433788|NCT00983073|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.|||Units on a scale||Standard Deviation|Mean
1433789|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available|||Units on a scale||Standard Deviation|Mean
1433790|NCT00983073|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.|||Units on a scale||Standard Deviation|Mean
1433791|NCT00983073|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 12 (12 Weeks)|Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1433792|NCT00983073|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; End of Week 6 (6 Weeks)|Number of participants with data available.|||units on a scale||Standard Deviation|Mean
1433793|NCT00983073|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS)where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline||||units on a scale||Standard Deviation|Mean
1433794|NCT00983073|Primary|The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline to end of week 6|All participants who had at least one dose of study medication and one post-baseline pain intensity assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1433795|NCT00982995|Secondary|To Determine the Partial Response (Relief of Nausea and Vomiting to the Extent That the Patient Desires Continued Dosing With Palonosetron,) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.||||||
1433796|NCT00982995|Primary|To Determine the Complete Response (no Vomiting and no Need for Nausea Rescue Medication) in Terminally Ill Patients Suffering From Nausea and/or Vomiting, Treated With Palonosetron.||96 hours after dosing|The study was unable to accrue the required number of patients to analyze the primary outcome.||||||
1433797|NCT00982735|Secondary|Change From Baseline in Microalbuminuria at 24 Weeks||Baseline and 24 weeks||||Participants|||Number
1433798|NCT00982735|Secondary|Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion|A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).|24 weeks||||Participants|||Number
1433799|NCT00982735|Primary|Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.||24 weeks||||Participants|||Number
1433800|NCT00982657|Secondary|Number of Participants With Anti- CVX-060 Antibodies||Baseline up to 28 days after last CVX-060 dose|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, no Anti-CVX-060 antibody assessment was conducted.||||||
1433948|NCT00981253|Secondary|Baroreflex Sensitivity|Baroreflex sensitivity was obtained from beat-to-beat heart rate and blood pressure recorded from patients in the supine position with a Nexfin noninvasive blood pressure monitor.|At 12 weeks||||ms/mm Hg||95% Confidence Interval|Least Squares Mean
1433801|NCT00982657|Secondary|Duration of Response|Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.|Baseline up to 7 days post last dose of study medication|Duration of response was not calculated as there were no participants with objective response.||||||
1433802|NCT00982657|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|Baseline up to 7 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
1433803|NCT00982657|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.|||Participants|||Number
1433804|NCT00982657|Secondary|Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels||Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study, pharmacodynamics assessment was not conducted.||||||
1433805|NCT00982657|Secondary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.|Baseline up to 28 days post last dose of study medication|Safety Analysis set consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
1433806|NCT00982657|Secondary|Pharmacokinetic Parameters of CVX-060|Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.|Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the phase II portion of the study,pharmacokinetics assessment was not conducted.||||||
1433807|NCT00982657|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.|Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study.The PFS endpoint was a pre-specified endpoint for the Phase II portion of the study, and was therefore not assessed.||||||
1433808|NCT00982657|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.|Baseline up to Cycle 1( Day 1 to Day 42)|The study was terminated during the Phase 1b phase by the sponsor prematurely. Due to the decision of not conducting the Phase II portion of the study, no MTD was assessed.||||||
1433809|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days of follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Events/100 years of patient exposure|||Number
1433810|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1433811|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104|Mean of 9-point SMPG at 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 140 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1433812|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 126 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1433813|NCT00982644|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1433814|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1433815|NCT00982644|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1433816|NCT00982644|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1433817|NCT00982644|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1433818|NCT00982592|Secondary|Incidence of Toxicities (grades1 and 2)|Defined as percentage of patients who experienced a toxicity with grade 1 or 2 (worst grade) related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.|Up to 4 years|All the patients who started the treatment.|||percentage of patients|||Number
1433819|NCT00982592|Secondary|Incidence of Toxicities (Grade 3 and Higher)|Defined as percentage of patients who experienced a toxicity with grade 3 or higher related to the protocol therapy. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0|Up to 4 years|All the patients who started the treatment.|||percentage of patients|||Number
1433820|NCT00982592|Secondary|Overall Survival|Defined as time from randomization day until death from any cause.|up to 4 years|Intent-to-treat population|||months||95% Confidence Interval|Median
1433821|NCT00982592|Secondary|Objective Response Rate|Defined as the percentage of the patients who had complete response (CR) or partial response (PR) per RECIST 1.1.|Up to 4 years|Intent-to-treat population|||percentage of patients|||Number
1433822|NCT00982592|Primary|Median Progression-free Survival (PFS)|PFS is defined as the time from randomization until objective tumor progression or death from any cause and is evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|up to 4 years|Intent-to-treat population|||months||95% Confidence Interval|Median
1433823|NCT00982553|Primary|Raltegravir Maximum Plasma Concentrations When Co-administered|On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.|Day 20||||ng/mL||95% Confidence Interval|Geometric Mean
1433824|NCT00982553|Primary|Ribavirin Maximum Plasma Concentration When Co-administered|On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.|Day 20||||ng/mL||95% Confidence Interval|Geometric Mean
1433825|NCT00982553|Primary|Raltegravir Alone Maximum Plasma Concentration|After a 14 day wash out participants took raltegravir 400 mg twice daily for 4 days. on day 19 they attended for intensive pharmacokinetic tests at 0 (pre-dose of raltegravir 400mg)then 0.5, 1, 2, 3, 4, 6, 8 and 12 hours|Day 19||||ng/mL||95% Confidence Interval|Geometric Mean
1433826|NCT00982553|Primary|Ribavirin Alone Maximum Plasma Concentration|On day 1 participants were administered a single dose of Ribavirin 800mg and then intensive pharmacokinetic blood samples were collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours|Day 1|Per protocol|||ng/mL||95% Confidence Interval|Geometric Mean
1433827|NCT00982488|Primary|Number of Participants Who Died and Had Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment through a maximum of 82 months + 30 days|All participants who received at least 1 dose of study drug|||Participants|||Number
1433828|NCT00982423|Secondary|Plasma Cyclic Guanosine Monophosphate (cGMP) at Baseline and in Response to Decreasing Furosemide Dose|Any change in atrial filling pressures leads to the release of atrial natriuretic peptides (ANP) from the heart. Once released, atrial peptides exert potent direct vasodilator and natriuretic actions by virtue of the ability to increase their intracellular second messenger, cGMP. Plasma cGMP correlates closely with the severity of congestive heart failure.|3 weeks, approximately 6 weeks||||pg/mL||Standard Deviation|Mean
1433829|NCT00982423|Secondary|Angiotensin II at Baseline and in Response to Decreasing Furosemide Dose|Renin activates the renin-angiotensin system by cleaving angiotensinogen, produced by the liver, to yield angiotensin I, which is further converted into angiotensin II by the angiotensin-converting enzyme (ACE) primarily within the capillaries of the lungs. Angiotensin II then constricts blood vessels, increases the secretion of antidiuretic hormone (ADH) and aldosterone, and stimulates the hypothalamus to activate the thirst reflex, each leading to an increase in blood pressure.|3 weeks, approximately 6 weeks||||pg/mL||Standard Deviation|Mean
1433830|NCT00982423|Secondary|Plasma Renin Activity at Baseline and in Response to Decreasing Furosemide Dose|Plasma renin activity is a measure of the activity of the plasma enzyme renin, which plays a major role in the body's regulation of blood pressure, thirst, and urine output. Renin is an enzyme that hydrolyses angiotensinogen secreted from the liver into the peptide angiotensin I. Renin's primary function is to cause an increase in blood pressure, leading to restoration of perfusion pressure in the kidneys.|3 weeks, approximately 6 weeks||||ng/mL/hr||Standard Deviation|Mean
1433831|NCT00982423|Secondary|Aldosterone at Baseline and in Response to Decreasing Furosemide Dose|Aldosterone is part of the renin–angiotensin-aldosterone system (RAAS). Drugs that interfere with the secretion or action of aldosterone are in use as antihypertensives, like lisinopril, which lowers blood pressure by blocking the angiotensin-converting enzyme (ACE), leading to lower aldosterone secretion. The net effect of these drugs is to reduce sodium and water retention but increase retention of potassium.|3 weeks, approximately 6 weeks||||ng/dL||Standard Deviation|Mean
1433832|NCT00982423|Secondary|Renal Plasma Flow at Baseline and in Response to Decreasing Furosemide Dose|Effective renal plasma flow (eRPF) is a measure used to calculate renal plasma flow (RPF) and hence estimate renal function. Renal plasma flow is the volume of blood plasma that flows through the kidneys per unit time, measured as ml/min.|3 weeks, approximately 6 weeks||||ml/min||Standard Deviation|Mean
1433833|NCT00982423|Primary|Renal Function as Measured by Glomerular Filtration Rate (GFR) at Baseline and in Response to Decreasing Furosemide Dose|Kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.|3 weeks, approximately 6 weeks||||ml/min||Standard Deviation|Mean
1433834|NCT00982410|Secondary|As-treated Analysis: The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. The outcome measure below represents the average WHY MPI General Activity score in each Arm/Group, across the entire follow-up period, adjusted for baseline WHY MPI General Activity score, but restricted here to study participants that partook in at least one treatment group session.|Baseline, 3mo, 6mo, 12mo follow-up||||units on a scale||Standard Error|Mean
1433835|NCT00982410|Secondary|As-treated Analysis: Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|Per study protocol, participants were asked to attend 10 sessions, which comprised the intervention for CBT participants and educational support for EUC participants. Some participants in each group did not attend any sessions, yet participated in follow-up assessments. The As-treated analysis was undertaken to evaluate the impact of the intervention, among participants that attended at least 1 session. As in the Primary Analysis, average pain last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation|Baseline, 3-, 6-, 12-months||||units on a scale||Standard Error|Mean
1433836|NCT00982410|Secondary|Self-efficacy of Physical Functioning|The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS subscale, self-efficacy for physical function (FSE), utilized to assess management of pain-related disability, with respect to several aspects of daily functioning. This scale have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS FSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of CPSS FSE.|Baseline, 3-, 6-, 12- months||||units on a scale||Standard Error|Mean
1433837|NCT00982410|Secondary|Self-efficacy of Pain Management|As measured via CPSS PSE score at each time point. The CPSS is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain (Anderson et al. 1995). The CPSS PSE subscale is a measure of self-efficacy for pain management. These scales have high reliability. Scores range from 10-100, with higher scores representing a better outcome. The outcome measure below represents the average CPSS PSE score in each Arm/Group, across the entire follow-up period, and was adjusted for baseline CPSS PSE.|Baseline, 3-, 6-, 12- months||||units on a scale||Standard Error|Mean
1433838|NCT00982410|Primary|Pain Tolerance|Pain tolerance was measured by the amount of time the participant could hold their hand immersed in a vessel of cold water in seconds. The maximum allowed duration of the test was two minutes. The outcome measure below represents the average duration of task in each Arm/Group, across the entire follow-up period, and was adjusted for baseline level of pain tolerance.|Baseline, 3-,6-,12-months||||seconds||Standard Error|Mean
1433839|NCT00982410|Primary|Drug Use|# days used illicit drugs in the past 30 days, as assessed via timeline follow-back (TLFB) calendars. Use of illicit drugs and misuse of prescription drugs (e.g., Rx opioids) were recorded for the 30 days prior to the follow-up visit. #days in a controlled environment (e.g., hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days drug use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used illicit drugs.|Baseline, 3-, 6-, 12- months||||#Days used||Standard Error|Mean
1433840|NCT00982410|Primary|Alcohol Use|#days used alcohol in the past 30 days, as assessed via timeline follow-back(TLFB) calendars. #days in a controlled environment (e.g. hospitalization, incarceration) also recorded to identify the duration of days at risk. The outcome measure below represents the average #days alcohol use in each Arm/Group, across the entire follow-up period, and was adjusted for baseline TLFB #days used alcohol.|Baseline, 3-, 6-, 12- months||||#Days used||Standard Error|Mean
1433841|NCT00982410|Primary|The Impact of Pain on Activities and Functioning: General Activity Score (WHY MPI)|The WHY MPI General Activity score is a composite construct designed to assess the extent to which physical pain impacts various aspects of daily living. Aspects include ability to perform chores inside the home, activities away from the home, and social functioning. The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period, and was adjusted for baseline WHY MPI General Activity score.|Baseline, 3-,6-, 12-month||||units on a scale||Standard Error|Mean
1433842|NCT00982410|Primary|Pain Intensity, as Measured by Average Pain Within the Last Week (NRS-1)|The outcome measure below represents the average pain levels in each Arm/Group, across the entire follow-up period. Average pain in the last week (NRS-1) is a scale ranging from 0 (no pain) to 10 (worst possible pain). The results reported below are based on longitudinal repeated measures modeling, adjusted for baseline NRS-1 average pain level. The variance was modeled to account for time interval (3-mo, 6-mo, 12-mo), and for session block; at the time of randomization, participants were assigned to blocks for a series of 10 sessions, in parallel for the intervention and control. Session blocks were utilized as a blocking variable to address between-block variation.|Baseline, 3-, 6-, & 12-months||||units on a scale||Standard Error|Mean
1433843|NCT00982397|Secondary|Percentage of Secondary Prevention Subjects Who Are Syncopal Event Free||Implant to one year post-implant|Includes randomized secondary prevention patients from Phase II.|||percentage of patients|||Number
1433844|NCT00982397|Primary|Percentage of Phase I Subjects Where the Ventricular Fibrillation (VF) Detection Time With Protecta Features on is no More Than 2 Seconds Longer Than the VF Detection Time With Protecta Features Off|In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.|At implant|Of the 236 subjects implanted, 40 subjects / episodes were classified as not useable. In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.|||percentage of patients||97.5% Confidence Interval|Number
1433845|NCT00982397|Primary|Percentage of Subjects With Unanticipated Severe Adverse Device Effects (Phase I)|In Phase I, only DR-ICD/CRT-D devices were implanted, so that for Phase I objectives there is only 1 arm to report results for.|Implant to one month post-implant|Phase I subjects (a subset of the total number of subjects) implanted with a Protecta device with at least 30 days of follow-up or a USADE within the first 30 days post-implant are included in this analysis. One hundred subjects met the criteria above and are included in the analysis.|||percentage of patients||95% Confidence Interval|Number
1433846|NCT00982397|Primary|Percentage of Subjects Who Are Inappropriate Shock Free|Primary objective of Phase II. Subjects implanted with a VR device will be analyzed separately from subjects implanted with a DR / CRT-D device. An inappropriate shock is a shock delivered by the defibrillator when the patient's heart rhythm was not a tachyarrhythmia, as adjudicated by the independent Episode Review Committee .|Implant to one year post-implant||||percentage of patients||95% Confidence Interval|Number
1433847|NCT00982345|Primary|17-item Hamilton Depression Rating Scale (HDRS)|Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.|Started: March 2009 Ending March 2011||||units on a scale||Standard Deviation|Mean
1433848|NCT00982319|Secondary|Phase II Protein Expression Levels of Cytoprotective Enzymes Known to be Modulated by Sulforaphane as Well as Morphological Changes in DCIS Specimens|Cytoprotective enzymes (NQ01 and AKR1C1 expression) based on immunohistochemical stains and qualitative assessment of morphological changes determined by study pathologists blinded to outcomes.|Change from baseline to 14 days post-intervention|||||||
1433849|NCT00982319|Primary|Absolute Change in Mean Proliferative Rate Measured by Ki67%|Pathologists score the slides without knowledge of treatment assignment at the end of the study. All pre-post samples from one individual will be evaluated together. Quality control for these stains is performed routinely in the immunohistochemistry lab (using lymphoid tissue for Ki67). Initial scoring is performed where possible on a minimum of 3000 cells, by counting the number of positive cells divided by the total number of cells. DCIS lesions will be scored separately to adjacent normal tissue. The rationale for selecting Ki67 as a measure of cellular proliferation includes the robustness of the staining reaction, correlation with the S phase fraction of the cell cycle and mitotic index and that it can be successfully ascertained from core breast biopsies provided there is an adequate yield of epithelial cells. A negative value reflects a decrease in ki67 positive cells, therefore a decrease in cellular proliferation.|Change from baseline to 14 days post-intervention|All participants who completed the 14-day intervention on either study arm were included in analysis.|||ki67%||Standard Deviation|Mean
1433949|NCT00981253|Secondary|Heart Rate Variability During Controlled Breathing (HRV-DB)|Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during a 100-second controlled breathing task.|At 12 weeks||||ms||95% Confidence Interval|Least Squares Mean
1433850|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Oxycodone|Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 6 participants with previous oxycodone treatment.|||Ratio|||Number
1433851|NCT00982280|Secondary|Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine|Tapentadol was compared to Transdermal Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Transdermal Buprenorphine.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT). 48 participants with previous transdermal buprenorphine treatment.|||Ratio|||Number
1433852|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 12 weeks|Intention to treat (ITT).|||participants|||Number
1433853|NCT00982280|Secondary|Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.|Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.|After 6 weeks|Intention to treat (ITT).|||participants|||Number
1433854|NCT00982280|Secondary|Participant's Satisfaction With Previous Analgesic Treatment.|Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.|Baseline|Intention to treat (ITT).|||participants|||Number
1433855|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).|||participants|||Number
1433856|NCT00982280|Secondary|Patient Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).|||participants|||Number
1433857|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 12 (12 Weeks)|Intention to treat (ITT).|||participants|||Number
1433858|NCT00982280|Secondary|Clinical Global Impression of Change|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End of Week 6 (6 Weeks)|Intention to treat (ITT).|||participants|||Number
1433859|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|12 Weeks|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1433860|NCT00982280|Secondary|Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|6 Weeks|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1433861|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|12 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Median
1433862|NCT00982280|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time|"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved."|6 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Median
1433863|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|12 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Mean
1433932|NCT00981435|Secondary|Intraocular Inflammation|The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.|Up to week 12|Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 31 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 35 available for data acquisition).|||Participants|||Count of Participants
1433864|NCT00982280|Secondary|Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6|The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.|6 weeks|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Mean
1433865|NCT00982280|Secondary|Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee|Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.|Baseline|Intention to treat (ITT).|||Units on a scale||Standard Deviation|Mean
1433866|NCT00982280|Secondary|Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 12 (12 weeks)|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1433867|NCT00982280|Secondary|Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment.|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity."|Baseline; Week 6 (6 weeks)|Intention to treat|||Units on a scale||Standard Deviation|Mean
1433868|NCT00982280|Secondary|Average Pain Intensity Before the Start of Tapentadol Treatment|"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline|Intention to Treat|||units on a scale||Standard Deviation|Mean
1433869|NCT00982280|Primary|Responder Rate|Participants were considered responders if they reported the same or less average pain intensity over a 3 day period after 6 weeks of tapentadol PR treatment as with their previous analgesic treatment.|6 weeks|Per Protocol Set. Last Observation Carried Forward (LOCF).|||Participants|||Number
1433870|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 7 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1433871|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1433872|NCT00982228|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1433873|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment|Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Treatment week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 12 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1433874|NCT00982228|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment|Change from baseline in HbA1c after 104 weeks of treatment|Week 0, Week 104|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1433875|NCT00982228|Primary|Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin|The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.|Week 0, Week 106|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||%B/T||Standard Deviation|Mean
1437521|NCT00953212|Secondary|Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation||30 days||||Participants|||Count of Participants
1433876|NCT00982228|Secondary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1433877|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 104 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1433878|NCT00982228|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 104 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Events/100 years of patient exposure|||Number
1433879|NCT00982228|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|The full analysis set (FAS) included all randomised subjects and missing data was imputed using LOCF (last observation carried forward).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1433880|NCT00982189|Secondary|Changes TNFa (Tumor Necrosis Factor Alpha)|This biomarker represents systemic inflammation within in the body.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||pg/mL||Standard Error|Geometric Mean
1433881|NCT00982189|Secondary|Changes IL-6 (Interleukin-6)|This biomarker represents systemic inflammation within in the body.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||pg/mL||Standard Error|Geometric Mean
1433882|NCT00982189|Secondary|Changes hsCRP (C-reactive Protein)|This biomarker represents systemic inflammation within in the body.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||mcg/mL||Standard Error|Geometric Mean
1433883|NCT00982189|Secondary|Changes in Small Artery Elasticity|Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events.|change from baseline to 4 months|Analysis presents the baseline-to-month4 difference between Lisinopril versus L-placebo groups; n=17 Lisinopril vs. n=17 L-placebo Our hypothesis for this secondary outcome was the 'main effect' for Lisinopril versus placebo would reduce inflammation. There was no interaction, so analyses define Lisinopril and L-placebo groups as for outcome #4|||mL/mmHgx100||Standard Error|Mean
1433884|NCT00982189|Secondary|Changes in Blood Lipids|Blood lipids include routine cholesterol measurements that are monitored in clinical practice. They are measured in blood after a blood draw is performed. The specific measurements include: a) total cholesterol, b) low-density lipoprotein cholesterol, c) high-density lipoprotein cholesterol, and d) triglycerides|change from baseline to 4 months|n = 18 Pravastatin vs. n = 16 P-placebo The outcome is analyzed as the 'main effect' for pravastatin versus placebo, as standard for factorial study designs. Since pravastatin, but not lisinopril, influences cholesterol, the analysis defines Pravastatin and P-placebo groups by pooling across lisinopril groups (i.e., L-placebo + Lisinopril group).|||(mg/dL)||95% Confidence Interval|Mean
1433885|NCT00982189|Secondary|Changes in Blood Pressure|Blood pressure was assessed by standard clinical methods (i.e., the same way it is measured during a routine clinic visit)|change from baseline to 4 months|n=17 Lisinopril vs. n=17 L-placebo The outcome is analyzed as the 'main effect' for lisinopril versus placebo, as standard for factorial study designs. Since lisinopril, but not pravastatin, influences blood pressure, the analysis defines Lisinopril and L-placebo groups by pooling across pravastatin groups (i.e., P-placebo + Pravastatin groups).|||(mmHG)||95% Confidence Interval|Mean
1433933|NCT00981435|Primary|Intraocular Pressure (IOP) Change|IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.|Baseline to Week 12|Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 27 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 33 available for data acquisition).|||mmHg||Standard Deviation|Mean
1433886|NCT00982189|Primary|Change From Baseline to Month 4 in the Framingham Risk Score (FRS)|The Framingham Risk Score is calculated by a published algorithm that predicts a patients risk of having a coronary heart disease event in the next 10 years. The measures that are considering in predicting this risk are: age, blood pressure, cholesterol (both total cholesterol and high-density lipoprotein cholesterol), smoking status, and use of medication to treat hypertension. This risk score can be estimated using an online calculator (http://hp2010.nhlbihin.net/atpiii/calculator.asp)|Change from baseline to 4 months|All participants had Framingham risk score (FRS) estimated at baseline and month 4. The change from baseline to month 4 was calculated as the outcome.|||Percent probability of CHD event in 10yr||Inter-Quartile Range|Median
1433887|NCT00982189|Primary|Number of Participants Who Took >90% of Their Doses (by Pill Count)|The number of pills missing from study medication bottles was counted by study nurses at the completion of the study. The proportion of pills taken divided by the number of days the participant was enrolled in the study was calculated, and multiplied by 100, to generate the '% of doses taken'|4 months|Number of participants who took >90% of their doses (by pill count)were studied. All participants who returned unused medications at end of the study were included for these analyses|||participants|||Number
1433888|NCT00982189|Primary|Number of Participants Who Stated (by Self-report) That They Had Side Effects|Participants were asked at each visit if they had any side effects to study medication. They provided a yes or no answer, and if yes they specified what the side effect was.|4 months|Number of participants who stated (by self-report) that they had side effects|||participants|||Number
1433889|NCT00982137|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain.~All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups."|Day 0 up to Day 60 post-vaccination|Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population).|||Participants|||Number
1433890|NCT00982137|Primary|Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination|Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples.|Day 0 (Pre-vaccination) through Day 30 post-vaccination|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).|||Participants|||Number
1433891|NCT00982137|Secondary|Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo|"Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test.~Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1433892|NCT00982137|Secondary|Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test.~Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)"|Day 0 through 6 months post-vaccination|GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1433893|NCT00982137|Primary|Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination.|"Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples.~The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population).|||Participants|||Number
1433931|NCT00981461|Primary|Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|Baseline, 16 weeks, 26 weeks||||hairs per cm^2||Standard Deviation|Mean
1433894|NCT00982137|Primary|Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination.|"Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples.~The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL)."|Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60)|Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population).|||Participants|||Number
1433895|NCT00982111|Secondary|Percentage of Participants With EGFR Measured by IHC|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment|||percentage of participants|||Number
1433896|NCT00982111|Secondary|Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria assesses participants with a low EGFR expression defined by a H-score cutoff value of < 200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|Baseline|Translational research population included all participants who: (1) received at least one dose of study drug; (2) had a valid non-missing result for EGFR H-Score; and (3) were enrolled for more than 2 cycles prior to the decision to terminate enrollment.|||H-Score||Standard Deviation|Mean
1433897|NCT00982111|Secondary|Mean Change From Baseline in PRO as Measured Using the Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle =3 Weeks)|All randomized participants who had evaluable baseline and postbaseline LCSS data.|||millimeter (mm)||Standard Deviation|Mean
1433898|NCT00982111|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimensions (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.|||units on a scale||Standard Deviation|Mean
1433899|NCT00982111|Secondary|Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-Necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline to Study Completion (Up to 31.6 Months)|All randomized participants who received at least one dose of necitumumab and had evaluable antibody data.|||participants|||Number
1433900|NCT00982111|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Predose Day 1 of Cycle 2,3,4,5 and 6 Prior to Necitumumab Infusion, Up to 23 Weeks|Participants who were randomized to necitumumab and had evaluable PK data.|||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
1433901|NCT00982111|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from study enrollment/randomization to the first observation of measured progressive disease, death from any cause, or early discontinuation of treatment or initiation of new anti-cancer therapies. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive Disease (PD) was defined as having at least a 20% increase in sum of longest diameter of target lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.|Randomization to Measured Progressive Disease, Death from Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin = 10, Pemetrexed + Cisplatin = 13|||Months||95% Confidence Interval|Median
1433902|NCT00982111|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 30.4 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1437522|NCT00953212|Secondary|Number of Participants With Acute Kidney Injury|Using the Akin definition|30 days||||Participants|||Count of Participants
1433903|NCT00982111|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participant was censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 30.4 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin=84, Pemetrexed + Cisplatin=79|||Months||95% Confidence Interval|Median
1433904|NCT00982111|Primary|Overall Survival Time (OS)|OS is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31.6 Months)|All randomized participants. Censored participants: Necitumumab + Pemetrexed + Cisplatin =79, Pemetrexed + Cisplatin=72|||Months||95% Confidence Interval|Median
1433905|NCT00982033|Primary|Exercise Treadmill Time|"Treadmill exercise time to exhaustion on the modified naughton protocol.~LS-mean is in effect, within-group means appropriately adjusted for the other effects in the model."|Baseline, 24 week visit||||seconds||Standard Deviation|Mean
1433906|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Anchored Version of the Brief Psychiatric Rating Scale for Children (BPRS-C) for Participants With Schizophrenia|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline, 52 weeks|All randomized participants with schizophrenia who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
1433907|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Clinical Global Impression - Severity (CGI-S) for All Participants|The CGI-S is used by the clinician to record the severity of illness at the time of assessment. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill.|Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
1433908|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Waist Circumference for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug.|||centimeters (cm)||Standard Error|Least Squares Mean
1433909|NCT00982020|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) at 52 Weeks for All Participants|The Clinical Global Impression of Improvement (CGI-I) is used by the clinician to record the improvement of illness at the time of assessment. The score ranges from 1 (very much improved) to 7 (very much worse).|52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
1433910|NCT00982020|Secondary|Mean Change From Baseline to 52 Weeks in Adolescent Structured Young Mania Rating Scale (YMRS) for Participants With Bipolar I Disorder|The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 (symptom not present) to 60 (symptom extremely severe).|Baseline, 52 weeks|All randomized participants with bipolar I disorder, who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology.|||units on a scale||Standard Error|Least Squares Mean
1433911|NCT00982020|Secondary|Time to Event for 7%, 15%, and 25% Weight Gain for All Participants|Kaplan-Meier methodology used to estimate time to event. Participants who never reached the target weight gain contributed to the set of patients at risk up to the point at which they discontinued from the study and were then censored (i.e., removed from the risk set).|Baseline up to 52 weeks|"65 participants (32%; 34% in Standard Group [SG], 30% in Intense Group [IG]) did not meet 7% weight gain criterion [WGC] by the time they discontinued.~122 participants (60%; 58% in SG, 62% in IG) did not meet 15% WGC by the time they discontinued.~161 participants (79%; 76% in SG, 82% in IG) did not meet 25% WGC by the time they discontinued."|||days||95% Confidence Interval|Median
1433912|NCT00982020|Secondary|Mean Change From Baseline to Endpoint in Body Mass Index (BMI) for Participants With Duration of Treatment of at Least 6 Months||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug and who had at least 6 months of data. Last observation carried forward (LOCF) methodology.|||kg/m^2||Standard Error|Least Squares Mean
1433913|NCT00982020|Primary|Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants||Baseline, 52 weeks|All randomized participants who received at least one dose of study drug. Mixed model repeated measures (MMRM) methodology used.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
1433914|NCT00982007|Primary|Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.||Day 35|Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment|||g/dL||Standard Deviation|Mean
1433915|NCT00981825|Primary|CFU (Colony Forming Units)|Total number of salivary bacterial colony forming units (lower number = less colonies present)|4 hours||||number of colony forming units||Standard Deviation|Mean
1433916|NCT00981812|Primary|Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.||At time of biopsy||||Breast Lesions|||Number
1433917|NCT00981669|Primary|Number of Participants With Adverse Events.|Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.|Within the first five days post-vaccination.||||participants|||Number
1433947|NCT00981253|Secondary|Heart Rate Variability During Rest|Heart rate variability was obtained from beat-to-beat heart rate. Heart rate was assessed from R-R interval changes elicited during 5 minutes of normal relaxed breathing|At 12 weeks||||ln (ms^2)||95% Confidence Interval|Least Squares Mean
1433918|NCT00981669|Secondary|Anti-rotavirus IgA Level.|It was evaluated by anti-rotavirus IgA levels in terms of optical density. Pre-vaccination levels of anti-rotavirus antibodies were not considered as an exclusion criterion. Seroconversion was considered as a fourfold increase in IgA titers. The proportion of seroconverters in both groups was compared. IgA levels in optical density were not converted to any unit of measure.|before each dose (total of doses:3) and after 6 weeks of the third dose|As in most phase I trials, sample size was not calculated to provide statistically significant differences between groups. Rather, a descriptive analysis on the frequency of AE and immunogenicity data was undertaken.|||Arbitrary units||Inter-Quartile Range|Median
1433919|NCT00981630|Secondary|Participants With Japanese Encephalitis (Homologous Virus) Seropositivity Over Time Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains. Seropositivity was defined as a titer < 1:10.|Day 30 up to 12 months post-vaccination|Seropositivity was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).|||Participants|||Number
1433920|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Wild Type JE Virus Strains) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|The Japanese Encephalitis (Wild Type JE Virus Strains) antibodies were measured using PRNT50 for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains.|Day 30 post-vaccination|Geometric mean titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1433921|NCT00981630|Secondary|Geometric Mean Titers to Japanese Encephalitis (Homologous Virus) Following Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE virus strains.|Day 11 and Day 30 post-vaccination|Geometric Mean Titers were assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion (Per-Protocol Population).|||Titers||95% Confidence Interval|Geometric Mean
1433922|NCT00981630|Primary|Number of Participants Reporting Solicited Local Injection Site and Treatment Related Adverse Events Post Vaccination With One of 3 Doses of ChimeriVax™-JE Vaccine or Placebo|Local Injection Site Adverse Events (AEs): Pain, Erythema, Reaction, Hemorrhage, Induration, Paresthesia. Treatment Related Systemic AEs: Fever, Chills, Malaise, Fatigue, Headache, Myalgia, Arthralgia, Nausea, Vomiting, Diarrhea, Rash. Other AEs as reported spontaneously.|Day 0 (post-vaccination) up to Day 30 post-vaccination|Adverse events were assessed in all randomized participants who received one injection of study treatment, according to the treatment actually received (Safety Population).|||Participants|||Number
1433923|NCT00981630|Primary|Number of Participants Who Seroconverted to Wild Type JE Virus Strains After Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or a Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination time points for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.|||Participants|||Number
1433924|NCT00981630|Primary|Number of Participants Who Seroconverted to the Respective Homologous JE Vaccine Strain, 28 Days After Completion of the Primary Immunization Schedule With One of 3 Doses of ChimeriVax™-JE Vaccine or A Placebo|Antibodies were measured using 50% plaque reduction neutralization test (PRNT50) for measurement of neutralizing antibodies against homologous ChimeriVax™-JE and wild type JE virus strains. Seroconversion was defined as a titer ≥ 1:20 at post vaccination timepoints for subjects who were seronegative at baseline, or ≥ 4 fold rise from baseline.|Day 11 and Day 30 post-vaccination|Seroconversion was assessed in all participants who were negative for homologous and all wild type JE antibodies at Day 0 and had no protocol violations that might have interfered with evaluation of primary criterion.|||Participants|||Number
1433925|NCT00981526|Secondary|Body Composition: Percent Total Body Fat|Body composition estimated by percent total body fat as measured by a dual energy absorptiometry (DXA) scan in both experimental and placebo arms at 12 weeks.|12 weeks||||percentage of body fat||Standard Deviation|Mean
1433926|NCT00981526|Secondary|Body Composition: Waist to Hip Ratio|Body composition as estimated by waist to hip ratio in both experimental and placebo arms at 12 weeks.|12 weeks||||Ratio||Standard Deviation|Mean
1433927|NCT00981526|Secondary|Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores.|The Positive and Negative Syndrome Scale (PANSS) and Scale for the Assessment of Negative Symptoms (SANS) were used to assess the positive and negative symptoms in experimental and placebo arms at 12 weeks. The PANSS total scale includes positive and negative subscales. For both subscales, the score ranges from 7-49 and total PANSS score ranges from 30-210. The total scale is a summation of all the subscales. The SANS score ranges from 0-100. For all scales, a greater score represents a worse outcome.|12 weeks||||units on a scale||Standard Deviation|Mean
1433928|NCT00981526|Secondary|Lipid Metabolism - LDL-cholesterol and HDL-cholesterol|Lipid metabolism - fasting low density lipoprotein (LDL) and high density lipoprotein (HDL) are estimated in both experimental and placebo arms at 12 weeks.|12 weeks||||mg/dl||Standard Deviation|Mean
1433929|NCT00981526|Primary|Triglycerides|Fasting triglycerides assessed in both experimental and placebo arm at week 12.|12 weeks||||mg/dl||Standard Deviation|Mean
1433930|NCT00981526|Primary|Insulin Resistance|Insulin resistance as estimated by homeostasis model of assessment of insulin resistance (HOMA-IR) at week 12 in both the experimental and placebo arm. Insulin resistance is a condition in which cells fail to respond to the normal action of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.|12 weeks||||HOMA-IR scores||Standard Deviation|Mean
1433934|NCT00981409|Secondary|The Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|FPX or UFH treatment period (Days 5-10, on average)|Safety population: all participants who received at least one dose of medication (FPX or UFH).|||percentage of participants|||Number
1433935|NCT00981409|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10|The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||points on a scale||Standard Deviation|Mean
1433936|NCT00981409|Secondary|The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse|"Improved, No change, or Worse was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE."|Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||percentage of participants|||Number
1433937|NCT00981409|Secondary|The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||percentage of participants|||Number
1433938|NCT00981409|Primary|The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute pulmonary thromboembolism (PE)|||percentage of participants|||Number
1433939|NCT00981370|Primary|To Determine if Red Cell Survival as Assessed by Hemoglobin Level, Reticulocyte Count, Lactic Acid Dehydrogenase, and Plasma Hemoglobin in Sickle Cell Patients is Related to the Degree of Iron Overload||Baseline, 6 months and 12 months|||||||
1433940|NCT00981305|Secondary|Change of Vaginal Maturation Index|Vaginal maturation index is a ratio obtained by performing a random cell count of the three major cell types shed from the vaginal squamous epithelium: parabasal, intermediate, and superficial cells. The higher the maturation index, the higher the number of mature cells (those designated superficial and intermediate).|Baseline and 8 weeks||||vaginal maturation index||Standard Deviation|Mean
1433941|NCT00981305|Secondary|Change of Vaginal pH||Baseline and 8 weeks||||pH||Standard Deviation|Mean
1433942|NCT00981305|Secondary|Change of a Total and Other Five Domains of Female Sexual Function Index Score|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1433943|NCT00981305|Primary|Change of Pain Score of Female Sexual Function Index|The Female Sexual Function Index (FSFI) is a 19-item self-reported instrument used for assessing key dimensions of female sexual function over the past 4 weeks with a total of six domains being analyzed. Each of the six specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI is scored on a scale ranging from 1.2 to 6.0 (desire), 0 to 6.0 (arousal, lubrication, orgasm, and pain) or 0.8 to 6.0 (satisfaction), with higher scores indicating better performance. The total score, falling in a possible range from 2.0 to 36.0, is obtained by adding the six domain scores together.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1433944|NCT00981292|Secondary|Number of Participants With Significant Modulation of Mood.|Mood was assessed via computerised visual analogue scales at baseline and post- dose time points. Mood scores were calculated as change from baseline. And significant modulation was determined if baseline scores were significantly different to post dose.|42 minutes|As long as data for all participants was captured for all 3 sessions then that participants data was utilized in the analysis.|||Participants|||Number
1433945|NCT00981292|Secondary|Number of Participants With Significant Modulation of Cognitive Performance|The cognitive performance of participants was assessed via a range of computerised, mentally demanding, executive function tasks: Serial 3s and 7s subtractions, oddball reaction time task, rapid visual information processing, stroop and simple reaction time.These tasks were completed at baseline and then again 45 minutes after treatment administration. Significant modulation was determined if participants' post dose scores were significantly higher than baseline.|42 minutes|If participants were deemed to have completed the tasks to the best of their ability then their scores were utilized in the analysis.|||Participants|||Number
1433946|NCT00981292|Primary|Modulation of Levels of Total Haemoglobin|This measure assessed changes in levels of total haemoglobin during the 42 minute post- dose task period. Levels are in μmol/L and represent change from baseline levels.|42 minutes|If NIRS readings were deemed not too affected by artefacts (usually caused by participants moving the headband in some way) then they were utilized in the analysis.|||μmol/L||Standard Error|Mean
1437523|NCT00953212|Secondary|Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement||30 days||||Participants|||Count of Participants
1433950|NCT00981253|Secondary|Change in High-sensitivity C-Reactive Protein|High-sensitivity C-reactive protein was quantified by ELISA. Values >10 mg/L were truncated at 10 to account for acute inflammatory processes that may have skewed the distribution of this blood marker.|Baseline; 12 weeks||||mg/L||95% Confidence Interval|Least Squares Mean
1433951|NCT00981253|Secondary|Major Adverse Cardiovascular Events (MACE) - All Cause Death, MI, Cardiac Revascularization and Cardiovascular Hospitalization.|Patients documented all medical encounters on an annual basis after enrollment. Medical records were reviewed, and events, categorized on the basis of American College of Cardiology/American Heart Association criteria. The following medical events were included: all-cause mortality, fatal and nonfatal myocardial infarction (MI), coronary or peripheral artery revascularization, stroke/transient ischemic attack, and unstable angina requiring hospitalization.|Baseline through Follow-up (median, 3.2 years)||||Participants|||Count of Participants
1433952|NCT00981253|Primary|Change From Baseline to 12 Weeks in Individual Scaled Scores|"Beck Depression Inventory II: 21-item scale used to measure depression. Scores range from 0 to 63, with higher scores suggesting greater depressive symptoms.~State-Trait Anxiety Inventory: 20-item scale which assess levels of state anxiety. Scores range from 20 to 80 with scores ≥40 suggesting clinically significant anxiety.~General Health Questionnaire:12-item measure of general distress. Scores range from 0 to 36, with higher scores indicating greater emotional distress.~Patient-Reported Outcomes Measurement Information System (PROMIS) Anger: 8-item scale which assesses anger. Scores range from 8 to 40, with higher scores indicating greater anger.~Perceived Stress Scale: 10-item measure of general distress and perceived ability to cope. Scores range from 0 to 40, higher scores indicate greater stress."|Baseline; 12 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
1433953|NCT00981253|Primary|Absolute Composite Stress Score|A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in primary outcome 2.|Baseline; 12 weeks||||Mean rank score||95% Confidence Interval|Least Squares Mean
1433954|NCT00981227|Other Pre-specified|Change in Mean Pain (NRPS) From Baseline to Endpoint by Total Daily Dose|Details of neuropathic pain, as recorded in a subject diary, were used for the primary assessment of analgesic efficacy. Subjects assessed their pain using an 11–point (0 “no pain” to 10 “worst possible pain”) NRPS upon awakening each morning and recorded the results in the subject diary. This score reflected the subject’s mean pain over the previous 24 hours. Subjects were trained how to record their pain reliably. Investigators were trained in the subject’s NRPS use during site initiation visits and at the investigators’ meeting.|baseline and 13 weeks||||Points||Standard Error|Least Squares Mean
1433955|NCT00981227|Primary|Change in Mean Pain (NRPS) From Baseline to Endpoint in Mean Pain|"The primary efficacy variable will be based upon an 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain, to be recorded in a patient's diary upon awakening each morning. This score should reflect the patient's mean pain over the previous 24 hours.~Please note that the change from baseline to endpoint in mean pain, i.e. the difference between endpoint mean pain and baseline mean pain, which are defined as follows:~Baseline mean pain is defined as the mean of the last four available ratings of average daily pain (NRPS) in the patient diary performed in the last 7 days before randomisation.~Endpoint mean pain is defined as the mean of the last four available ratings of average daily pain in the patient diary in the last 7 days of the treatment period."|baseline and 13 weeks||||Points||Standard Error|Least Squares Mean
1433956|NCT00981214|Secondary|Percentage of Stool With Visible Oil or Grease|Mean percentage of oil or grease at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of stools||Standard Deviation|Mean
1433957|NCT00981214|Secondary|Percentage of Blood in Stool|Mean percentage of stools with blood at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.|||percentage of stools||Standard Deviation|Mean
1433958|NCT00981214|Secondary|Physician’s and Parent’s or Legal Guardians Assessment of Improvement in Clinical Symptoms|Clinical symptoms of exocrine pancreatic insufficiency (EPI) were assessed by the physician and parent or guardian to determine if the participant showed improvement in symptoms of EPI at end of study after the dose stabilization period. EPI is a syndrome characterized by clinical symptoms of poor absorption of fats, proteins, and to a lesser extent, carbohydrates, which manifests primarily in patients with cystic fibrosis. Number of participants with improvement in clinical symptoms was reported.|Day 19 (end of study)|Analysis population set included all participants who received at least 1 dose of study.|||participants|||Number
1433959|NCT00981214|Secondary|Mean Number of Pain Symptoms|Symptoms of pain was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population set included all participants who received at least 1 dose of study.|||pain symptoms per day||Standard Deviation|Mean
1433960|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Flatulence|Flatulence is presence of excessive gas in the digestive tract. Symptoms of flatulence was classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||flatulences per day||Standard Deviation|Mean
1435999|NCT00965185|Secondary|Endothelial Function|Assessment of endothelial function was to be measured by endothelial vasodilator function.|1 year|"Please note that we were unable to collect data for this outcome measure, entitled Endothelial Function due to equipment malfunction."||||||
1433961|NCT00981214|Secondary|Mean Number of Abdominal Symptoms: Bloating|Bloating is swelling of the intestinal tract caused by excessive gas formation. Symptoms of bloating were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptoms of specific severity for each participant was calculated from frequency of symptoms by the participant per day. Mean number of symptoms at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||bloatings per day||Standard Deviation|Mean
1433962|NCT00981214|Secondary|Percentage of Stool Categorized by Consistency|Stool consistency was categorized as hard, formed/normal, soft, watery or overt diarrhea. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period) and Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of stools||Standard Deviation|Mean
1433963|NCT00981214|Primary|Percentage of Participants Who Were Responders After 2 Weeks of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30% fecal fat content) and without signs and symptoms of malabsorption after 2 weeks of treatment with study medication.|Day 18 (end of treatment)|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1433964|NCT00981214|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools at each period for total participants was summarized.|Baseline, Day 5 up to Day 11 (dose stabilization period), Day 12 up to Day 18 (treatment period)|Analysis population included all participants who received at least 1 dose of study medication.|||stools per day||Standard Error|Mean
1433965|NCT00981214|Secondary|Change From Baseline in Weight at Day 12, 19||Baseline, Day 12, 19|Analysis population included all participants who received at least 1 dose of study medication.|||kilogram||Standard Deviation|Mean
1433966|NCT00981214|Primary|Percentage of Participants Who Were Responders After 1 Week of Treatment With Study Medication|Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.|Day 11|Analysis population included all participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1433967|NCT00981175|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events Recorded as Possibly, Probably, or Definitely Related to Study Treatment.|Treatment emergent adverse events were assessed in all participants receiving ChimeriVax-JE Vaccine, Diluent (Placebo), or Booster Vaccination.|Day 0 up to 28 post-vaccination|Treatment emergent adverse events were assessed in the Safety Population.|||Participants|||Number
1433968|NCT00981175|Primary|Number of Participants Reporting Injection Site Treatment Emergent Adverse Events Post-Vaccination With ChimeriVax™-JE or Placebo at Day 0 and Day 28, and Following a Booster of ChimeriVax™-JE at Month 6 in a Subset of the Study Population.|Injection Site Treatment Emergent Adverse Events: Pain, Reaction Not Otherwise Specified (NOS), Erythema, Swelling, Bruising, Nodule, Pigmentation Changes, Pruritus were assessed in all participants for up to 28 days post-Vaccination.|Days 0 to 28 post-vaccination|Injection site reactions were assessed in the Safety Population.|||Participants|||Number
1433969|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at month 24.|Month 24 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population|||Participants|||Number
1433970|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed or Not by a Booster Vaccine Dose at 6 Month.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and followed or not by a booster vaccine dose at 6 month.|Month 12 post-vaccination|Immunogenicity was assessed in the Intent to Treat Population|||Participants|||Number
1433971|NCT00981175|Secondary|Number of Participants With Seroconversion to Homologous ChimeriVax™-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Followed by a Booster Vaccine Dose.|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28 and pre- and post-Booster vaccination.|Month 6 pre- and post-vaccination|Immunogenicity was assessed in the Intent to Treat Population pre- and post-booster vaccination.|||Participants|||Number
1433972|NCT00981175|Primary|Number of Participants With Seroconversion to Homologous ChimeriVax-JE Virus Strain After a Single Dose of Chimerivax™-JE and Placebo Dose|Assay by 50% Plaque Reduction Neutralization Test (PRNT50) Seroconversion: PRNT50 ≥ 10 and PRNT50 ≥ 20. Assessed in all participants who received ChimeriVax™-JE vaccine on Day 0 and Day 28.|Day 28 post-vaccination|Immunogenicity was assessed in the Intent-to-Treat Population.|||Participants|||Number
1433973|NCT00981149|Secondary|Evoked Pain Via Algometry .|Assessment of evoked pain using digital palpation examination at 18 predefined bodily sites.|6 weeks||||Pain pressure threshold (kg/cm2)||Standard Deviation|Mean
1433974|NCT00981149|Primary|Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks.|Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS).|1, 3, 6 weeks||||units on a scale||Standard Deviation|Mean
1433975|NCT00981084|Primary|Word Generation|Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||number of words generated||Standard Deviation|Mean
1433976|NCT00981084|Primary|Stroop|Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||number of colors named||Standard Deviation|Mean
1433977|NCT00981084|Primary|CPT -Test of Information Processing Speed|"Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores.~Continuous Performance Test (CPT) - Vigilance and reaction time."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||milliseconds||Standard Deviation|Mean
1433978|NCT00981084|Primary|Learning and Memory Measures.|"Testing was completed after first intervention and again after second intervention.~Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores.~Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75).~RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15).~Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36).~BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12)."|Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.||||Items recalled||Standard Deviation|Mean
1433979|NCT00981058|Secondary|Number of Participants With a Serum Anti-Necitumumab Antibody Assessment|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.|Baseline through 31 Months|All randomized participants who received who received at least 1 dose of drug and had evaluable data for antibodies.|||participants|||Number
1433980|NCT00981058|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Day 1 of Cycle 2, 3, 4, 5 and 6 Prior to Necitumumab Drug Infusion, Up to 24 Months|All randomized participants who received at least one dose of study drug and had evaluable data for PK.|||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
1433981|NCT00981058|Secondary|Number of Participants With an Epidermal Growth Factor Hormone (EGFR) Protein Expression Measured by Immunohistochemistry (IHC)|EGFR IHC Histoscore H-score = weighted sum of % 1+ cells, twice % 2+ cells, and three times % 3+ cells. IHC H-score criteria was used to assess participants with a low EGFR expression defined by a H-score cutoff value of <200 and participants with a high EGFR expression defined by a H-score of cutoff value of >=200.|31 Months|All randomized participants who received at least one dose of study drug and had evaluable data for EGFR IHC.|||participants|||Number
1433982|NCT00981058|Secondary|Mean Change From Baseline in PRO Using the Outcomes Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. Scores for each of the reported categories ranged from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively.|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable data for LCSS.|||millimeter (mm)||Standard Deviation|Mean
1433983|NCT00981058|Secondary|Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Cycle 6 (Cycle = 3 Weeks)|All randomized participants who had evaluable baseline and postbaseline EQ-5D data.|||units on a scale||Standard Deviation|Mean
1433984|NCT00981058|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization until the date of the first radiographic documentation of PD, death from any cause, discontinuation of treatment for any reason, or initiation of new cancer therapy. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.|Randomization to Measured Progressive Disease, Death From Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 16, Gemcitabine + Cisplatin =20|||Months||95% Confidence Interval|Median
1433985|NCT00981058|Secondary|Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a >=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 31 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1433997|NCT00980980|Secondary|ICU-attributable All-pathogen Bloodstream Infection|Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.|||Hazard ratio||95% Confidence Interval|Number
1434798|NCT00975650|Primary|Serum Dihydrotestosterone Ln-AUCt||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng.h/dL||Standard Deviation|Mean
1433986|NCT00981058|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131|||months||95% Confidence Interval|Median
1433987|NCT00981058|Primary|Overall Survival Time (OS)|Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.|Randomization to Death from Any Cause (Up to 31 Months)|All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 127, Gemcitabine + Cisplatin = 106|||Months||95% Confidence Interval|Median
1433988|NCT00981045|Primary|Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.|The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.|Day 120||||participants|||Number
1433989|NCT00981045|Primary|Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.||Day 56||||g/dL||Standard Deviation|Mean
1433990|NCT00981019|Secondary|Number of Physicians (= Participants) Assuming a Benefit of Screening|Physicians are faced with four different medical statistics about the effect of screening (e.g., 5-year survival) within four successive scenarios and after each scenario asked whether they assume the screening to be beneficial given the statistical information. Options to answer are: yes, no, can't decide. If yes, then participants are further asked to describe this benefit by the following categories: Very large, large, moderate, small, very small.|25 minutes (mean duration of the survey)||2011-08-31|08/2011||||
1433991|NCT00981019|Primary|Number of Physicians (=Participants) Recommending the Screening|The aim of the study was to learn how different medical cancer screening statistics would influence doctors' recommendation behavior and their effectiveness judgments of screening tests. For that reason the online survey study presented physicians with four different medical statistics (e.g., 5-year survival) within four successive scenarios and asked after each scenario whether they would recommend the screening to a (hypothetical) patient given the data. Options to answer are: Definitely yes, Probably yes, Probably no, Definitely no, Can’t decide.|25 minutes (mean duration of the survey)|We calculated that a sample size of 300 physicians was needed to have 90% power to detect differences of 20% or higher in the proportion of respondents correctly answering questions about the different cancer statistics (2-sided alpha of .05).|||participants|||Number
1433992|NCT00980980|Secondary|Intervention Impact on Chlorhexidine Susceptibility of MRSA Isolates|Frequency of MRSA+ isolates from ICU patients with reduced susceptibility to chlorhexidine (CHG) (MIC >4 μg/ml), comparing baseline to intervention period across arms, accounting for clustering by hospital.|25-month time frame represents 7-month baseline and 18-month intervention periods|The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.|||MRSA isolates non-susceptible to CHG|MRSA+ isolates||Number
1433993|NCT00980980|Secondary|Intervention Impact on Mupirocin Susceptibility of MRSA Isolates|Odds ratio for MRSA+ isolates from ICU patients expressing low-level mupirocin resistance (LLMR) and high-level mupirocin resistance (HLMR), comparing baseline to intervention period across arms, accounting for clustering by hospital.|25-month time frame represents 7-month baseline and 18-month intervention periods|The total number of participants analyzed reflects the combined total of baseline and intervention participants during the outcome time frame, for each arm. The total number of units analyzed reflects the combined total of MRSA+ isolates collected from ICU patients during baseline and intervention phase, for each arm.|||Odds Ratio|MRSA+ isolates|95% Confidence Interval|Number
1433994|NCT00980980|Secondary|Intervention Impact on Bacteriuria and Candiduria|Proportional hazard ratio for as-randomized, unadjusted, ICU-attributable bacteriuria, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital. High-level bacteriuria is defined as ≥50,000 CFU/mL, high-level candiduria is defined as ≥50,000 CFU/mL.|30-month time frame represents 12-month baseline and 18-month intervention periods.|The number of participants analyzed reflects the combined total of baseline and intervention admissions with an ICU stay, for each arm.|||Hazard Ratio||95% Confidence Interval|Number
1433995|NCT00980980|Secondary|Blood Culture Contamination Rates|Odds ratio for ICU-attributable blood culture contamination rates, comparing Baseline to Intervention period across Arms, accounting for clustering by hospital.|24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.|The number of participants analyzed reflects the combined total of baseline and intervention admissions, with an ICU stay and a blood draw set, for each arm.|||Odds Ratio||95% Confidence Interval|Number
1433996|NCT00980980|Secondary|Intervention Impact on Healthcare Costs|Costs (in dollars) per 1000 ICU-admissions associated with 3 ICU strategies to reduce ICU Bloodstream infection (BSI), (Arms 1-3).|12-month period|Annual adult ICU admissions per hospital, over the course of 1 year.|||Dollars per 1000 ICU-admissions|||Number
1434026|NCT00980343|Secondary|Changes in Sonic Hedgehog Pathway Activation|determined by Reverse transcription polymerase chain reaction (RT-PCR) and immunohistochemistry (IHC) (Gli-1, Gli-2, PATCH (PTCH-1b)|Pre-tumor resection and post tumor resection (12 hours)|only small number of samples and thus not enough to give useful information. Samples not processed for outcome and analysis was not performed. No numerical data to report||||||
1433998|NCT00980980|Secondary|MRSA Bloodstream Infection|Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.|||hazard ratio||95% Confidence Interval|Number
1433999|NCT00980980|Primary|Main Outcome: Patients With Nosocomial MRSA Clinical Cultures|Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.|The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge.|The total number of participants analyzed included the table reflects the combined total of baseline and intervention participants, for each arm.|||hazard ratio||95% Confidence Interval|Number
1434000|NCT00980798|Secondary|The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event|The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.|At each study visit from baseline until week 16|Safety population: All randomised patients who received at least one dose of study drug.|||participants|||Number
1434001|NCT00980798|Primary|Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)|"The analgesic effect was assessed by the BPI item 5 “pain on average” using a 0 to 10 numeric rating scale, with 0 being no pain and 10 being pain as bad as you can imagine."|At each study visit from screening to week 16|The primary population for the efficacy analyses was the intention to treat (ITT) population: all randomised patients who received at least one dose of study drug excluding patients who had no post-baseline efficacy data. This population included patients who discontinued early owing to lack of efficacy or other reasons.|||units on a scale||Standard Deviation|Mean
1434002|NCT00980746|Primary|Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain|﻿Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period.|17 weeks||||units on a scale||Standard Error|Least Squares Mean
1434003|NCT00980681|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared|1 to 7 days||||percentage of non-assessable segments|||Number
1434004|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434005|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434006|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434027|NCT00980343|Secondary|Incidence of CD133+ Neurospheres by Arm|number of tumor-derived CD133 neurospheres undergoing proliferation and self-renewal|12 hours post-vismodegib administration||||percent of CD133 Neuospheres|||Number
1434028|NCT00980343|Secondary|Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0|NCI CTCAE grade 3 or 4 possible, probable or definitely related events Grade 3 - severe Grade 4 - life threatening|30 days from last dose of drug treatment - 1.5 years||||percent of participants|||Number
1434007|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434008|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 4|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434009|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434010|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434011|NCT00980655|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 1|Safety population. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1434012|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.|1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
1434042|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment who achieved plasma HCV RNA levels of <25 IU/mL undetectable at selected time points during treatment and follow-up and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434013|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
1434014|NCT00980655|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||fold rise||95% Confidence Interval|Geometric Mean
1434015|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 4|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||mcg/mL||95% Confidence Interval|Geometric Mean
1434016|NCT00980655|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3|Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies all participants who were evaluable for this measure and 'n' signifies all participants who were evaluable for specified serotype for each treatment arm, respectively.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1434017|NCT00980655|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.|Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.|||fold rise||95% Confidence Interval|Geometric Mean
1434018|NCT00980642|Secondary|Specificity for Detection of Hypothermia|Hypothermia will be defined as a temperature < 36 Celsius degree|From anesthesia induction to the end of surgery||||percent of non-hypothermias||95% Confidence Interval|Number
1434019|NCT00980642|Secondary|Sensitivity for Detection of Hypothermia|Hypothermia is defined as a temperature < 36 Celsius degree|From anesthesia induction to the end of surgery||||percent of hypothermias||95% Confidence Interval|Number
1434020|NCT00980642|Primary|The Bias Between Temperature Measured by Drager Double-sensor vs Core Temperature|Determine if the Drager double-sensor temperature monitoring system, used at the forehead is accurate compared to esophageal temperature for general anesthesia group and bladder temperature for regional anesthesia group.|From anesthesia induction to the end of surgery||||Celsius degree||95% Confidence Interval|Mean
1434021|NCT00980590|Secondary|Incidence of Intubation Complications|Including mucosal trauma, dental injury, lip injury, hypoxia (SPO2<95%) and Esophageal intubation|Intubation period||||cases|||Number
1434022|NCT00980590|Secondary|Number of Intubation Attempts||Intubation period||||times|||Number
1434023|NCT00980590|Secondary|Overall Intubation Success Rate||Intubation period||||Percentage of overall intubation|||Number
1434024|NCT00980590|Primary|Intubation Time|For the case with number of intubation attempt no more than 3, intubation time was defined as the total time of individual intubation attempt. Otherwise, intubation was defined as a failure and excluded from the calculation of intubation time.|The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography.|Patients with number of intubation attempt no more than 3|||seconds||Standard Deviation|Mean
1434025|NCT00980343|Secondary|Determine Drug Effect (Pharmacokinetics) in Plasma for Arm 1|samples collected pre tumor resection (day of surgery) and post-tumor resection (day of surgery|Day of surgery||||ng/ml||Standard Deviation|Median
1434029|NCT00980343|Secondary|Best Tumor Response Assessed by the Modified Macdonald Radiographic Response Criteria|"The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features~1: complete response; 2: partial response; 3:stable disease; 4:progression~Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved~Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved~Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable~Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration"|evaluated every 8 weeks - 1 year|3 subjects not evaluable for radiographic response Arm 1 and 4 subjects not evaluable for radiographic response in Arm 2|||participants|||Number
1434030|NCT00980343|Secondary|Overall Survival Time|The overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.. Start date based on onset of treatment.|3 years||||months||95% Confidence Interval|Median
1434031|NCT00980343|Primary|6 Months Progression-free Survival (PFS)|Estimated using Kaplan Meier curves. six months calculated from date of treatment onset post-operatively. MRI scan at 6 months must be free of progression Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.|6 months||||percentage of patients||95% Confidence Interval|Number
1434032|NCT00980330|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each TMC435 treatment group.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng.h/mL||Full Range|Median
1434033|NCT00980330|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for TMC435 for participants in each of the 6 TMC435 treatment groups.|0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng/mL||Full Range|Median
1434034|NCT00980330|Secondary|The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved the normal ALT levels at the EOT (up to Week 48).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434035|NCT00980330|Secondary|The Percentage of Participants With Viral Relapse|The table below shows the percentage of participants in the overall population who had viral relapse, defined as confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) during the follow-up period in participants with HCV RNA less than 25 IU/mL undetectable at end of treatment.|Up to Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434036|NCT00980330|Secondary|The Percentage of Participants With Viral Breakthrough|The table below shows the percentage of participants in the overall population in each treatment group during the treatment period who experienced viral breakthrough, defined as a confirmed increase of greater than 1 log10 IU/mL in Hepatitis C virus (HCV) ribonucleic acid (RNA) from the lowest level reached or a confirmed HCV RNA of > 100 IU/mL in participants whose HCV RNA had previously been below the lower limit of quantification (i.e., less than 25 IU/mL detectable or undetectable).|EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434037|NCT00980330|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants in the overall population who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the planned EOT.|Week 60|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434038|NCT00980330|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma levels of Hepatitis C virus ribonucleic acid at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434039|NCT00980330|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a greater than or equal to 2 log10 reduction in plasma Hepatitis C virus ribonucleic acid from baseline at Week 12.|Week 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434040|NCT00980330|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having an undetectable plasma Hepatitis C virus ribonucleic acid level after receiving 4 weeks of treatment.|Week 4|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434041|NCT00980330|Secondary|The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels below the limit of quantification defined as less than 25 IU/mL (detectable or undetectable) at selected time points during treatment, follow-up, and at the end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of Participants|||Number
1436000|NCT00965185|Secondary|Plaque Progression|12 month percent change in plaque volume|Measured at baseline and 1 year|All available data were used.|||Percent change||95% Confidence Interval|Mean
1434043|NCT00980330|Secondary|The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment|The table below shows the percentage of participants in each treatment group who achieved a greater than 2 log10 drop in plasma levels of HCV RNA at selected time points during treatment.|Weeks, 2, 4, 8, and 12|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434044|NCT00980330|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)|The table below shows the percentage of participants in the overall population with an SVR24, defined as having plasma levels of Hepatitis C Virus ribonucleic acid less than 25 IU/mL undetectable at the EOT and 24 weeks after the EOT.|Week 72|Intent-to-treat: Participants who received at least 1 dose of study medication were included.|||Percentage of participants|||Number
1434045|NCT00980278|Secondary|Final Bone Volume: Initial Graft Volume Ratio|Bone volume fraction of bone core histological and µCT analyses|4 months||||ratio||Standard Deviation|Mean
1434046|NCT00980278|Secondary|Change in Sinus Bone Volume|CBCT was used to evaluated 3-D changes in the bone volume within the treated areas of the sinus cavity|Pre-baseline and within 2 weeks of 4 Month visit||||cm3||Standard Deviation|Mean
1434047|NCT00980278|Primary|Bone Volume Fraction of Bone Core|Bone volume fraction of bone core histological and µCT analyses|4 months||||ratio||Standard Deviation|Mean
1434048|NCT00980278|Secondary|Change in Linear Radiographic Bone Height|Change in linear radiographic bone heights were measured before and after bone graft reconstruction|Screening and 1 week post-op from baseline||||mm||Standard Deviation|Mean
1434049|NCT00980278|Primary|Bone Mineral Density of Bone Core|Bone mineral density of bone core was measured by histological and µCT analyses|4 months||||mg/mm^3||Standard Deviation|Mean
1434050|NCT00980200|Secondary|Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean was derived by calculating the average area under curve, and then dividing by the relevant time interval. 24-hour serial measurements of FEV1 were performed on Day 7 of each of the 5 treatment periods (Visits 3, 5, 7, 9, and 11). Measurements were taken at pre-dose; 30 and 60 minutes; and 3, 5, 11, 12, 12.5, 13, 15, 17, 23, and 24 hours post-dose. Visits 3, 5, 7, 9, and 11 were overnight visits. Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed effects analysis of covariance (ANCOVA) model, with fixed effects for treatment, period, sex, and age. Participant was fitted as a random effect, and the period Baseline FEV1 measurement was included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Liters||Standard Error|Least Squares Mean
1434051|NCT00980200|Primary|Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the mean of the FEV1 values obtained at the last two scheduled time points at the Day 7 clinic visit (i.e., 11 and 12 hours after the morning dose, or 23 and 24 hours after the evening dose). Change from Baseline was calculated as the Day 7 value minus the Baseline value. Analysis was performed using a mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants is fitted as a random effect, and the period Baseline measurement is included as part of a bivariate response. The model for the period Baseline value is not affected by treatment group.|Baseline and Day 7 of the treatment period (up to Study Day 63)|Intent-to Treat (ITT) Population: all participants randomized to treatment who received at least one dose of trial medication. Randomized participants were assumed to have received trial medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
1434052|NCT00980174|Secondary|Serum Type 1 Collagen C-telopeptide (CTX) Percent Change From Baseline at Day 15||From Baseline to Day 15||||Percent||Inter-Quartile Range|Median
1434053|NCT00980174|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
1434054|NCT00980174|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
1434055|NCT00980174|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
1434056|NCT00980174|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months||||Percent||95% Confidence Interval|Mean
1434057|NCT00980174|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||From Baseline to 12 Months|Subjects with baseline and at least one post baseline measurements|||Percent||95% Confidence Interval|Mean
1434058|NCT00980148|Secondary|Demographical Characteristics and Clinical Parameters to Predict Treatment Outcome.||Baseline and study visit #2 (Day 28 after therapy is started)|||||||
1434059|NCT00980148|Primary|Assess Microbiological Failure of Recommended Azithromycin and Doxycycline Regimens in Uncomplicated Chlamydia Trachomatis Infection in a Setting Where Repeat Exposure to Chlamydia-infected Persons Can be Minimized.|The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).|Study visit # 2 (Day 28 after therapy started)|The per protocol population is comprised of participants who completed therapy and whose failure status could be established at the day 28 visit. Participants were considered to have completed therapy if they took a single dose of azithromycin or at least 10 of the 14 doses of doxycycline.|||percentage of participants|||Number
1434106|NCT00979654|Secondary|Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab|The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||days||Standard Deviation|Mean
1434060|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 8-13 (all groups now on placebo)|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean number of doses/day across the days listed.|||mean # of doses per day||Standard Error|Mean
1434061|NCT00980044|Primary|Subjective Opioid Withdrawal Adjective Total Score Week 2|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present|days 8-13|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean total withdrawal score across the days listed.|||units on a scale||Standard Error|Mean
1434062|NCT00980044|Primary|Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1|There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.|Days 1-7|These are data from week 1 -- the 12 people who completed this week in each group. This is the analysis that was specified at the start of the study. The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.|||Mean doses per day||Standard Error|Mean
1434063|NCT00980044|Primary|Subjective Opioid Withdrawal Total Adjective Score|range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T|Days 1-7|The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.|||units on a scale||Standard Error|Mean
1434064|NCT00980005|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434065|NCT00980005|Secondary|Number of Subjects Reporting Medically Attended Adverse Events (MAEs).|For each solicited and unsolicited symptom the subject experiences, the subject/subject’s parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.|During the entire study period (From Day 0 up to Day 180).|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434066|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.~Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434067|NCT00980005|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.~Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination."|During a 28 day follow-up period (Days 0-27) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434068|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.|"Solicited local symptoms assessed were pain, redness and swelling.~Any = occurrence of any solicited general symptom regardless of intensity grade.~Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm).~All solicited local AEs were considered to be causally related to vaccination.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434069|NCT00980005|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|"Solicited local symptoms assessed were pain, redness and swelling.~Any = occurrence of any solicited general symptom regardless of intensity grade.~Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm).~All solicited local AEs were considered to be causally related to vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434070|NCT00980005|Secondary|Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).~Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.~Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.~Related = symptom assessed by the investigator as causaly related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434103|NCT00979654|Secondary|Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab|The Ctrough is the minimum observed serum concentration at steady state of sifalimumab.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1434071|NCT00980005|Secondary|Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).|"The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).~Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.~Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.~Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.~Related = symptom assessed by the investigator as causally related to the vaccination."|During a 4-day follow-up period (Days 0-3) after vaccination.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
1434072|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.~Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Fold increase||95% Confidence Interval|Mean
1434073|NCT00980005|Secondary|Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.~Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen."|At Day 0 and at Day 28 after last vaccine dose|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Fold increase||95% Confidence Interval|Mean
1434074|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Subjects|||Number
1434075|NCT00980005|Secondary|Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Subjects|||Number
1434076|NCT00980005|Secondary|Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Subjects|||Number
1434077|NCT00980005|Secondary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs).~Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1434078|NCT00980005|Primary|Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer."|At Day 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Subjects|||Number
1434104|NCT00979654|Secondary|Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab|The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||microgram.day per milliliter(mcg*day/mL)||Standard Deviation|Mean
1434079|NCT00980005|Primary|Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.|"The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.~Titers were expressed as geometric mean antibody titers (GMTs)."|At Day 0 and 28 after last vaccine dose.|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1434080|NCT00979992|Other Pre-specified|Changes in Serum and Plasma Angiogenesis Markers by Enzyme-linked Immunosorbent Assays||Baseline to up to 5 years|||||||
1434081|NCT00979992|Other Pre-specified|Change in Pro-angiogenic Protein Levels||Baseline to up to 5 years|||||||
1434082|NCT00979992|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|Grade 3 or higher adverse events were graded by CTC AE v 4.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.|Eligible and treated patients|||participants|||Number
1434083|NCT00979992|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1|Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter for up to 5 years.|Eligible and treated patients.|||months||90% Confidence Interval|Median
1434084|NCT00979992|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated patients.|||months||90% Confidence Interval|Median
1434085|NCT00979992|Primary|The Percentage of Patients Who Survive Progression Free for at Least 6 Months|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months|Eligible and treated patients.|||percentage of participants||90% Confidence Interval|Number
1434086|NCT00979992|Primary|Objective Tumor Response Rate (Complete and Partial Response)|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
1434087|NCT00979953|Primary|Change From Baseline in the Average Pain Score (NPRS) for Week 2|The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.|Baseline, Week 2|All participants who received at least 1 dose of study medication and had at least evaluable 1 NPRS postdose measurement. Last-observation-carried-forward (LOCF) was used to impute missing postbaseline values.|||units on a scale||Standard Deviation|Least Squares Mean
1434088|NCT00979940|Primary|Periprocedural Myonecrosis||16-24 hours post PCI||||participants|||Number
1434089|NCT00979901|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2|Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no baseline or treatment period data were available. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1434090|NCT00979901|Secondary|Physician's Global Evaluation of Allergic Rhinitis at Week 2|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Scores were measured as 0 (best) to 6 (worst).|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1434091|NCT00979901|Secondary|Patient's Global Evaluation of Allergic Rhinitis at Week 2|"An evaluation by the patient, administered at the last visit (or~upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the~study. Scores were measured as 0 (best) to 6 (worst)."|Week 2|This secondary endpoint analysis was performed using the intention-to-treat approach. Patients were excluded if no treatment period data were available. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1434105|NCT00979654|Secondary|Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1434092|NCT00979901|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1434093|NCT00979901|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The secondary efficacy analyses were based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1434094|NCT00979901|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks|"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily~on a 4-point scale. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal~Symptoms Score. Scores were measured as 0 (best) to 3 (worst)."|Baseline and Week 2|The primary efficacy analysis was based on the ITT (all-patients treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1434095|NCT00979875|Secondary|Time to Percentage of Total Insulin Exposure|Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + rHuPH20, Glulisine alone, Glulisine + recombinant human hyaluronidase PH20 (rHuPH20), Aspart alone, or Aspart + rHuPH20 with evaluable total insulin exposure data.|||minutes||Standard Deviation|Mean
1434096|NCT00979875|Secondary|Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)|Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.|Predose up to 120 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20) , Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-t data.|||percentage of total AUC||Standard Deviation|Mean
1434097|NCT00979875|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tGIR(max) data.|||minutes||Standard Deviation|Mean
1434098|NCT00979875|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable t(50%max) data.|||minutes||Standard Deviation|Mean
1434099|NCT00979875|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|Predose up to 480 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tmax data.|||minutes||Standard Deviation|Mean
1434100|NCT00979875|Primary|Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)|Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.|Predose up to 60 minutes postdose|Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-60 data.|||minutes*nanomolars (min*nM)||Standard Deviation|Mean
1434101|NCT00979654|Secondary|Number of Participants With Positive Anti-Drug Antibody|Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study.|Day 1 and Week 12, 24, 52, 104, 156 and 168|Safety Population included all participants who received at least one dose of investigational product.|||Participants|||Number
1434102|NCT00979654|Secondary|Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab|The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose.|Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||ratio||Standard Deviation|Mean
1437524|NCT00953212|Secondary|Number of Participants With Respiratory Failure Requiring Reintubation||30 days||||Participants|||Count of Participants
1434107|NCT00979654|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab|The Tmax is the time to reach maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||days||Full Range|Median
1434108|NCT00979654|Secondary|Maximum Observed Serum Concentration (Cmax) for Sifalimumab|The Cmax is the maximum observed plasma concentration of sifalimumab.|Pre-infusion and End of Infusion on Day 1|The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, “N” is number of participants analyzed for this outcome measure.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1434109|NCT00979654|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration until week 182|Safety Population included all participants who received at least one dose of investigational product.|||participants|||Number
1434110|NCT00979628|Secondary|To Determine Differences Between Treatments Arms in # of Hypoglycemic Events||during hospitalization|||||||
1434111|NCT00979628|Primary|To Determine Glycemic Control Between Basal Plus(Glargine Once Daily Plus Corrective Doses of Glulisine Before Meals and Bedtime as Needed), Basal Bolus Approach of Glargine Once Daily Plus Glulisine Before Meals and SSRI||during hospitalization||||mg/dl||Standard Deviation|Mean
1434112|NCT00979615|Secondary|Mean Change in Sneezing Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks||||Units on a scale||Standard Deviation|Mean
1434113|NCT00979615|Secondary|Mean Change Nasal Congestion Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks||||Units on a scale||Standard Deviation|Mean
1434114|NCT00979615|Secondary|Mean Change Postnasal Drip Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 Weeks||||Units on a scale||Standard Deviation|Mean
1434115|NCT00979615|Secondary|Mean Change in Rhinorrhea Reflective Score|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week||||Units on a scale||Standard Deviation|Mean
1434116|NCT00979615|Primary|Mean Change in 2-week rTNSS From Baseline|Change from baseline after 2 weeks in responses to patient-completed diaries for reflective Total Nasal VMR Symptom Scores (rTVSS). TVSS is composed of 4 individual assessments, which included nasal congestion, rhinorrhea, post nasal drip and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are totaled for a composite score (TVSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.|2 week||||Units on a scale||Standard Deviation|Mean
1434117|NCT00979602|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1434118|NCT00979602|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Within the 42-day (Days 0-41) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1434151|NCT00979576|Secondary|Overall Response Rate|Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set|||Participants|||Number
1434119|NCT00979602|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1434120|NCT00979602|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1434121|NCT00979602|Secondary|Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], total bilirubin [T/BIL], bilirubin direct [BIL/D], creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were – unknown, below, within and above for subjects aged 18-64 years (18-64y) and >64 years old (>64y).|At Days 7 and 21|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1434122|NCT00979602|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
1434123|NCT00979602|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (>64y).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
1434124|NCT00979602|Secondary|Number of ILI Symptoms in All Reported ILI Cases|Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.|From Day 14 post-vaccination through the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
1434125|NCT00979602|Secondary|Number of ILI Symptoms in All Reported ILI Cases|Assessed ILI symptoms were fever [defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.|From Day 0 up to the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
1434126|NCT00979602|Secondary|Number of A/California Influenza Related Cases|Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.|From Day 0 up to the end of ILI surveillance (Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
1434127|NCT00979602|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1434128|NCT00979602|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1437525|NCT00953212|Secondary|Number of Participants With Postoperative Vasoplegia||30 days||||Participants|||Count of Participants
1434129|NCT00979602|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Participants|||Count of Participants
1434130|NCT00979602|Secondary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Participants|||Count of Participants
1434131|NCT00979602|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Participants|||Count of Participants
1434132|NCT00979602|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Participants|||Count of Participants
1434133|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Titers||95% Confidence Interval|Geometric Mean
1434134|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 182|The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.|||Participants|||Count of Participants
1434135|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Titers||95% Confidence Interval|Geometric Mean
1434136|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 42|The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.|||Participants|||Count of Participants
1434137|NCT00979602|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Titers||95% Confidence Interval|Geometric Mean
1434152|NCT00979576|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.~CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE)."|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set|||participants|||Number
1434138|NCT00979602|Secondary|Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|"Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.~The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance."|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
1434139|NCT00979602|Primary|Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases|The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.|From Day 14 post-vaccination up to study end (at Day 385)|The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.|||Events|||Number
1434140|NCT00979602|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Fold increase||95% Confidence Interval|Geometric Mean
1434141|NCT00979602|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 21|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
1434142|NCT00979602|Primary|Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain|A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
1434143|NCT00979602|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain|A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.|||Participants|||Count of Participants
1434144|NCT00979576|Secondary|Cmax of Pemetrexed|Maximum measured concentration of pemetrexed in plasma (Cmax)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1434145|NCT00979576|Secondary|AUC0-inf of Pemetrexed|Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1434146|NCT00979576|Secondary|Cmax of Nintedanib|Maximum measured concentration of nintedanib in plasma (Cmax)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1434147|NCT00979576|Secondary|AUC0-inf of Nintedanib|Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1|Pharmacokinetic (PK) set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1434148|NCT00979576|Secondary|Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in >= 20% of patients|Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days|Treated set|||participants|||Number
1434149|NCT00979576|Secondary|Duration of Disease Control|Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier.|From first study drug administration until PD or death, up to 1003 days|Patients from the treated set who achieved disease control|||Days||Full Range|Median
1434150|NCT00979576|Secondary|Disease Control Rate|Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Every 6 weeks after start of study treatment until end of treatment, up to 992 days|Treated set|||Participants|||Number
1434158|NCT00979459|Primary|Area Under the Concentration Versus Time Curve (AUC(0-infinity)) for MK-1006|AUC (0-infinity) is the area under the curve for the plot showing plasma concentration against time from time zero to the time of the last quantifiable concentration for two formulations of MK-1006, FCT and DFC|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours post-dose||||nM*hr||95% Confidence Interval|Geometric Mean
1434159|NCT00979420|Secondary|Number of Participants With Drug Related Adverse Events|Number of participants with drug related Adverse Events (AEs)|Up to 185 months|Treated set|||participants|||Number
1434160|NCT00979420|Secondary|Course of Absolute CD4+ Cell Count|The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years|||CD4+ cells/mm3||Full Range|Median
1434161|NCT00979420|Secondary|History of Therapy With Antiretroviral Medication|Participants with a history of therapy with antiretroviral medication.|Baseline|Treated set|||participants|||Number
1434162|NCT00979420|Secondary|Duration of Intake of Viramune|Duration of intake of Viramune|End of treatment, up to 185 months|Treated set|||months||Full Range|Median
1434163|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Hemoglobin.|||Participants|||Number
1434164|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of Creatinine.|||Participants|||Number
1434165|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of AST|||Participants|||Number
1434166|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of ALT|||Participants|||Number
1434167|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of blood glucose|||Participants|||Number
1434168|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of triglycerides.|||Participants|||Number
1434169|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS AE Grading Table was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of LDL cholesterol.|||Participants|||Number
1434170|NCT00979420|Secondary|Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade|"Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening."|Up to 185 months|Patients from Treated set (TS, all patients receiving at least one dose of study medication) with at least one documentation of cholesterol.|||Participants|||Number
1434171|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.|||CD4+ cells/mm3||Full Range|Median
1434172|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|PPS: All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.|||Participants|||Number
1434173|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.|||log10 copies/ml||Full Range|Median
1434174|NCT00979420|Primary|Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.|||CD4+ cells/mm3||Full Range|Median
1434175|NCT00979420|Primary|Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit||Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.|||Participants|||Number
1434176|NCT00979420|Primary|Change in log10 Viral Load From Baseline to Last Visit|Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.|Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.|Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.|||log10 copies/ml||Full Range|Median
1434177|NCT00979407|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1434178|NCT00979407|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21 days after the first vaccination (Days 0 - 20) and 63 days after the second vaccination (up to Day 84)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1434179|NCT00979407|Secondary|Number of Subjects With Any Adverse Event of Special Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1434180|NCT00979407|Secondary|Number of Subjects With pIMDs|A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1434181|NCT00979407|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|A pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1434182|NCT00979407|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1434183|NCT00979407|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C and ≤ 40°C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
1434184|NCT00979407|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1434185|NCT00979407|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects, who had their symptom sheets filled in.|||Participants|||Count of Participants
1434186|NCT00979407|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Fold increase||95% Confidence Interval|Geometric Mean
1434187|NCT00979407|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|GMFR was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1434188|NCT00979407|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Participants|||Count of Participants
1434189|NCT00979407|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.|||Participants|||Count of Participants
1434190|NCT00979407|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Titers||95% Confidence Interval|Geometric Mean
1434191|NCT00979407|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1434192|NCT00979407|Secondary|Number of SCR Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 post to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 182 and 364|The ATP cohort for persistence at Day 182 and 364 included all evaluable subjects who had received at least 1 dose of study/control vaccine, according to their treatment assignment during the primary vaccination course, and for whom assay results were available for antibodies against the study vaccine antigen component at Days 182 and 364.|||Participants|||Count of Participants
1434193|NCT00979407|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first and second vaccine dose.|||Participants|||Count of Participants
1434194|NCT00979407|Primary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received 1 vaccine dose and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the first vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1434195|NCT00979303|Secondary|Total Radiation Exposure|Total radiation exposure measured in mGy|During Ablation Procedure||||mGy||Full Range|Median
1434196|NCT00979303|Primary|Total Fluoroscopy Time|Total fluoroscopy time in minutes|During the Ablation procedure||||minutes||Full Range|Median
1434197|NCT00979212|Secondary|Response Rate|Patients are assessed for best response to protocol treatment using the RECIST criteria. The response rate was calculated as the number of patients who have a complete response (CR) or partial response (PR) divided by the total number of analyzable patients at completion of induction chemoradiation +/- panitumumab and prior to anticipated surgery in each arm. Patients without a documented assessment are considered as not having a CR or PR. Rates are not compared across arms.|From date of randomization to time of protocol surgery, approximately 12 weeks.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1434198|NCT00979212|Secondary|Ability of FDG-PET/CT Scan Data to Predict Outcome|FDG-PET/CT scan data has not been obtained and therefore this outcome measure cannot be reported.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|||||||
1434279|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroprotection: The percentage of participants with a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
1434199|NCT00979212|Secondary|Surgical Morbidities in Patients With Resectable Disease at Reassessment|A surgical morbidity is any toxicity occurring within 30 days of protocol surgery, as evaluated using CTCAE v4.0. Rates of grade 3 and higher surgical morbidity were calculated; the rates across arms were not compared.|From date of surgery to 30 days following surgery.|All eligible patients who started study treatment and received protocol surgery|||percentage of patients||95% Confidence Interval|Number
1434200|NCT00979212|Secondary|Percentage of Patients With Grade 3 or Higher Acute and Late Adverse Events|Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Does not include surgical morbidities. An acute adverse event is defined as any grade 3 or worse toxicity occurring during protocol treatment and within 30 days from the end of protocol treatment that is possibly, probably, or definitely related to treatment. Acute adverse events are any adverse events occurring within 30 days of the end of all protocol treatment. Late adverse events are any adverse events occurring after 30 days after the end of all protocol treatment.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1434201|NCT00979212|Secondary|Patterns of First Failure|The first failure site will be tabulated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study.|All eligible patients who started study treatment|||participants|||Number
1434202|NCT00979212|Secondary|Overall Survival|Survival time was calculated from the date of randomization to the date of death from any cause or the date of last follow-up. The Kaplan-Meier method was used to estimate the overall survival rates. One-year survival rates were estimated, not compared.|Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1434203|NCT00979212|Primary|Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.|The assessment of whether mediastinal nodes which were involved at the time of study registration were clear of disease following induction chemoradiotherapy with or without panitumumab; the assessment is made at the time of surgery 4-6 weeks after chemoradiation. If surgery could not be performed, the patient was considered as not having had mediastinal nodal clearance.|From date of randomization to time of protocol surgery, approximately 12 weeks.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1434204|NCT00979199|Secondary|Cost-benefit and Cost-effectiveness Analysis|Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point.|3 months|||||||
1434205|NCT00979199|Primary|Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement|The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions).|3 months from enrollment||||participants|||Number
1434206|NCT00979121|Other Pre-specified|Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14|CRP levels were collected on subjects at baseline and on-study. The change in concentration from baseline levels to levels on study days 6 and 14 was analyzed. Those subjects that were still alive and on study at day 6 and 14 with a measured CRP level were included in the analysis.|6 and 14 days after randomization||||mg/dL||Standard Deviation|Mean
1434207|NCT00979121|Other Pre-specified|Other Secondary Out-comes|Percentage of subjects with Arrhythmia's, Bowel Ischemia, Myocardial Infarction, Ischemic Stroke, and Thromboembolism were measured.|28 days after randomization||||percentage of participants||95% Confidence Interval|Number
1434208|NCT00979121|Other Pre-specified|ICU Free Days to Day 28||28 days after randomization||||days||Standard Deviation|Mean
1434209|NCT00979121|Other Pre-specified|Organ Failure Free Days at Day 14|The number of days from randomization to day 14 without an organ failure. Four main organ systems were measured: cardiovascular, coagulation, hepatic function, and renal function.|14 days after randomization||||days||Standard Deviation|Mean
1434210|NCT00979121|Secondary|Ventilator Free Days at Study Day 28|Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.|time of initiating unassisted breathing to day 28 after study randomization||||days||Standard Deviation|Mean
1434211|NCT00979121|Primary|Hospital Mortality to Day 60.|The percentage of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.|60 days after randomization||||percentage of participants||95% Confidence Interval|Number
1434212|NCT00979069|Primary|Executive Language Functions|The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, & Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct|number of correct words at pre and post separated by 12 weeks||||Mean outpoint by group at pre and post||Standard Deviation|Mean
1434213|NCT00979017|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat|||months||95% Confidence Interval|Median
1434214|NCT00979017|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, worsening T2/FLAIR, any new lesion, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|36 months|Intent-to-treat|||months||95% Confidence Interval|Median
1434215|NCT00979017|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of treatment-related, grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat|||participants|||Number
1434216|NCT00979017|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage and Systemic Hemorrhage|Incidence and severity of CNS hemorrhage and systemic hemorrhage- The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, and have been converted to CTCAE version 4.0 for entry into ClinicalTrials.gov.|4 months|Intent-to-treat|||participants|||Number
1434217|NCT00979017|Primary|Response Rate|The percentage of participants with a complete or partial response as determined by a modification of the Response Assessment in Neuro-Oncology (RANO) criteria. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Per the criteria, confirmation of response was required. Response rate = CR+PR.|4 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1434218|NCT00978757|Primary|The Effect of Ketamine on Interleukin 6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)||Plasma concentration of IL-6 levels were obtained prior to surgery, upon placement of the first intravenous||||pg/ml||Standard Deviation|Mean
1434219|NCT00978731|Secondary|Median Number of Months of Overall Survival (OS) (Kaplan Meier Method)|Overall survival was defined as the median number of months from baseline to death from any cause.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||months||95% Confidence Interval|Median
1434220|NCT00978731|Secondary|Median Number of Months of Progression-free Survival (PFS) (Kaplan Meier Method)|Interval between randomization date & earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): >=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments & were still alive, date of randomization used.|Baseline to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||months||95% Confidence Interval|Median
1434221|NCT00978731|Secondary|Number of Participants With Best Cytogenetic Response|Cytogenetic responses are based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR: 0% Ph+ cells in metaphase in bone marrow, PCyR: >0% to 35% Ph+ cells in metaphase in bone marrow, Minor CyR: >35% to 65% Ph+ cells in metaphase in bone marrow, Minimal CyR: >65% to 95% Ph+ cells in metaphase in bone marrow and No CyR: >95% to 100% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.|||participants|||Number
1434222|NCT00978731|Primary|Number of Participants With Dose Interruptions and Dose Reductions|Dose interruptions and reductions were allowed, in order to optimize individual participant’s hematologic, cytogenetic, and molecular response while maintaining and evaluating safety and tolerability of long-term exposure to dasatinib. A dose reduction is defined as the administration of a dose at a lower level compared to previous dose and such that reduced dose, or a lower dose, is given at least 4 consecutive times. In determining the reductions, dose level would be compared to the previous non-null dose. Dose interruption is defined as a complete omission of dosing for 4 consecutive times.|From start of study to final assessment (up to 32.2 months).|All treated participants.|||participants|||Number
1434223|NCT00978731|Secondary|Median Number of Months of Major Cytogenetic Response (MCyR)|MCyR: 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.The duration of MCyR was computed for chronic phase participants whose best response is either CCyR or PCyR. It was measured in months from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the date of progression or death. Participants who neither progress nor die are censored on the date of their last cytogenetic assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had MCyR (13 participants had MCyR in QD group and 9 in BID group). Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.|||months||95% Confidence Interval|Median
1434224|NCT00978731|Primary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|Abnormalities were graded per the NCI (CTC), v3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Alanine aminotransferase (ALT): Grade 3: 5.0-20.0 * ULN (upper limit of normal), Grade 4: >20.0 * ULN; Calcium: Grade 3: 6.0-<7.0 or >12.5-13.5 mg/dL, Grade 4: <0.6->13.5 mg/dL; Bilirubin: Grade 3: >3-10 * ULN, Grade 4: >10 * ULN; Creatinine: Grade 3: >3.0-6.0 * ULN, Grade 4: >6.0 * ULN; Albumin: Grade 3: <2g/dL (Grade 4 not defined in NCI CTC); Magnesium: Grade 3: 0.6-<0.8 or >2.46-6.6mEq/L, Grade 4: <0.6 or >6.6mEq/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
1437526|NCT00953212|Secondary|Number of Participants With Low Output Heart Failure||30 days||||Participants|||Count of Participants
1434225|NCT00978731|Secondary|Number of Participants With Major Cytogenetic Response (MCyR)|Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): >0% to 35% Ph+ cells in metaphase in bone marrow.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable.|||participants|||Number
1434226|NCT00978731|Secondary|Median Number of Months of CHR (Kaplan Meier Method)|CHR: WBC<=ULN (range: 9.29-12.5*10^3 c\uL); ANC >=1000/mm^3;Platelets <450000/mm^3,no blasts/promyelocytes in peripheral blood; <5% myelocytes+metamyelocytes in peripheral blood; basophils in peripheral blood <20% & no extramedullary involvement. Duration computed for chronic phase participants, measured in months from first day CHR criteria met, provided they are confirmed 4 weeks later, until progression of disease, treatment discontinuation due to progressive disease or death. Participants who neither discontinue due to progression, nor progress nor die censored on date of last assessment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants with CML (whether QD or BID dosing), who had CHR. Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.|||months||95% Confidence Interval|Median
1434227|NCT00978731|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR should meet all of the following criteria: WBC <= Institutional ULN; ANC >= 1000/mm^3 ; Platelets < 450 000/mm^3 , no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; basophils in peripheral blood < 20% and no extramedullary involvement (including no hepatomegaly or splenomegaly). CHR can begin only 14 days after the start of treatment.|Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants. Data was not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes.|||participants|||Number
1434228|NCT00978731|Primary|Number of Participants With Grade 3-4 Hematology Abnormalities|Abnormalities were graded per the National Cancer Institute(NCI)Common Toxicity Criteria (CTC), v3.0(Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - <8.0g/dL, Grade 4: <6.5g/dL. Platelets: Grade 3: 25.0 - <50.0*10^9/L, Grade 4: <25.0*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - <1.0*10^9/L, Grade 4: <0.5*10^9/L.White Blood Cells (WBC) : Grade 3: 1.0 - <2.0*10^9/L, Grade 4: <1.0*10^9/L.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
1434229|NCT00978731|Primary|Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs.|Drug-related AEs are those events with a relationship to the study therapy of certain; probable; or possible or missing. Drug-related SAEs are those events with any relationship to the study therapy.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
1434230|NCT00978731|Primary|Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation.|AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled.|From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months.|All treated participants.|||participants|||Number
1434231|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 53 + 7 days of follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1434232|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment|Change from baseline in FPG after 52 weeks of treatment.|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects, FPG values were missing.|||mmol/L||Standard Deviation|Mean
1434233|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1434280|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
1434234|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1434235|NCT00978627|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.|Week 0 to Week 53 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1434236|NCT00978627|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 53|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1434237|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26|Overall mean of 9-point SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 22 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1434238|NCT00978627|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1434239|NCT00978627|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1434240|NCT00978562|Secondary|Volume of Enhancing Lesions|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
1434241|NCT00978562|Secondary|Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
1434242|NCT00978562|Secondary|Tumor Vascularity|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
1434243|NCT00978562|Secondary|Number of Enhancing Lesions|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
1434244|NCT00978562|Secondary|Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol)|Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.|Up to 2 years||2018-12-31|12/2018||||
1434245|NCT00978562|Primary|Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent|Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.|up to 2 years||||min^-1||Standard Deviation|Mean
1434246|NCT00978562|Primary|Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol|Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA).|Up to 2 years||||mL/g||Standard Deviation|Mean
1434247|NCT00978445|Secondary|Change in Quality of Life - Based on Quality of Life Scores PSQ-18 (Short Form Patient Satisfaction Questionnaire) Duke Anticoagulation Satisfaction Scale SF-12 (Short Form 12 Version 2) Quality of Life Questionnaire|"we are interested in the relative measure of quality of life by comparing quality of life measures through use of PSQ-18 and other measures listed.~Higher scores indicate a better quality of life."|During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3|power analysis|||scores on a scale||Standard Deviation|Mean
1434248|NCT00978445|Primary|Time Spent Per PT/INR Monitoring Encounter|minutes spent measuring coagulation time of blood on standard versus home protocol|Once per week during 12 week study|through minimum power study|||minutes||Standard Deviation|Mean
1434342|NCT00977574|Secondary|Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.||Median of 10 cycles of treatment plus 30 days|Treated patients|||Participants|||Count of Participants
1437527|NCT00953212|Secondary|Number of Participants With Stroke|Cerebral vascular accident occurring within hospital length of stay|30 days||||Participants|||Count of Participants
1434249|NCT00978432|Secondary|Evaluate the Association of Observed Response to the Doublet With the Response Predicted by Molecular Signatures for Activated B Cell Like (ABC) DLBCL and for Germinal Center B Cell Like (GCB) DLBCL.|"Response rates seen in subjects with activated B cell like DLBCL and for Germinal center B cell like DLBCL will be reported and assessed to see if GCB is associated with improved outcomes compared to ABC in subjects with relapsed disease who have received RAD + LBH. We will estimate the association of the ABC and GCB with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses.~The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis."|up to 13 cycles of therapy; approximately 1 year|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.||||||
1434250|NCT00978432|Secondary|Distribution of Change Across Time of mTOR and HDAC-I Inhibition From Baseline Until After the 1st 2 Cycles of Study Drug in Patients Who Received LBH and RAD.|Serum markers will be measured on the first day of cycle 1 and on the first day of cycle 3. The distribution of change across time in a marker will be summarized.|after 2 cycles of study therapy; up to 8 weeks|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, serum marker analysis was not performed and no results are available.||||||
1434251|NCT00978432|Secondary|Summary of Adverse Events (AEs)|Counts of adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose) experienced by patients on study drug(s). National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) is used to assess severity. Relatedness to study drug is assessed by the investigator.|From the time of first dose of study drug until 4 weeks after participant has stopped study drug; up to 1 year|Participants who consented to the study and took study drug were analyzed for this outcome measure. Total number of events per CTCAE v4 category per arm are reported if more than one event occurred.|||events|||Number
1434252|NCT00978432|Primary|Assessment of Association Between Observed Response to RAD001 and LBH589 and the Response Predicted by Molecular Signatures Developed in Our Pre-clinical Model|We will estimate the association of the molecular signature-predicted response to the doublet (CR+PR) with the observed response. All evaluable patients will be used in estimating response. The chi-square test with one-sided alpha of 0.10 will be used to test for the association between predicted and observed responses. Contingency tables will be used to present these associations.|From the start of combination therapy until a maximum of 2 years after completion of therapy|The number of responses to treatment were so few that we did not think we could get enough meaningful data for analysis. Therefore, molecular analysis was not performed and no results are available.||||||
1434253|NCT00978432|Primary|Overall Response Rate|Overall Response Rate is the number of participants with a partial and complete response assessed by the Updated Cheson criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. If a subject has residual lesions on CT scan and the disease was fluorodeoxyglucose (FDG) avid pre-treatment, then that subject will be considered to be in a complete response. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|after 2 cycles of each study drug or after 2 cycles of doublet, up to 24 weeks|Patients have to be on each drug for at least 2 cycles to be evaluable for response.|||participants|||Number
1434254|NCT00978419|Secondary|Determine the Prevalence of Functional Impairment in Burn Patients and by Study Group||90 days|||||||
1434255|NCT00978419|Secondary|Determine the Prevalence of De-novo Long-term Neurocognitive Impairment in Burn Patients and by Study Group.||90 days|||||||
1434256|NCT00978419|Secondary|Determine the Prevalence of Delirium in the Two Subgroup of Patients||28 days|||||||
1434257|NCT00978419|Secondary|Determine Which Are Appropriate Attainable Endpoints for Future Trials and the Number of Participants Required to Reach Significance in Analysis of a Variety of Variables||28 days|||||||
1434258|NCT00978419|Secondary|Determine the Safety of Rosuvastatin Compared to Placebo in Burn Patients by Comparing the Frequency, Type and Severity of Adverse Events||28 days|||||||
1434259|NCT00978419|Secondary|A Reduction in ALT Levels Over Time, Compared to Placebo, Measured at Baseline, Days 1, 7, 14, 21, 28||28 days|||||||
1434260|NCT00978419|Secondary|A Reduction in CK Levels Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14, 21, 28||28 days|||||||
1434261|NCT00978419|Secondary|Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo, Adjusted for Cardiovascular Co-morbidities||28 days|||||||
1434262|NCT00978419|Secondary|Reduction in the Incidence of Septic Shock (See Definition) Compared to Placebo||28 days|||||||
1434263|NCT00978419|Secondary|Mortality Compared to Placebo, Adjusted for Cardiovascular Co-morbidities||90 days|||||||
1434264|NCT00978419|Secondary|Mortality Compared to Placebo||90 days|||||||
1434265|NCT00978419|Primary|Primary Endpoint: Reduction in CRP Level Over Time, Compared to Placebo Measured at Baseline and Days 3, 7, 14. The Mean CRP Levels at Specified Days Will be the Endpoints.||Days 1, 3, 7, 14|||||||
1434266|NCT00978380|Secondary|Antibody and Inhibitor Development|All subjects who received rFXIII were monitored for anti-rFXIII antibodies and inhibitor development. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors. Percentage of subjects with antibody and inhibitor development were reported.|From week 0 to week 52|The safety analysis set included all subjects exposed to trial product in this extension trial.|||Percentage of subjects|||Number
1434394|NCT00977197|Secondary|Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy|"One of the weekly questions asked of subjects was, Did you have adequate relief of your IBS symptoms over the last week? Possible answers were Yes or No."|Weeks 9-12|Intent to treat analysis|||participants|||Number
1434267|NCT00978380|Primary|Adverse Events (AEs)(Serious and Non-serious)|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Trial AEs (serious) included any event such as death, life-threatening experience, in-subject hospitalisation, significant disability/ congential anomaly experienced from the trial product.|All AEs were collected and reported from screening (week 0) for a minimum period of 52 weeks or until the end of trial visit.|The FAS included the 60 unique subjects exposed to trial product in this extension trial.|||Events|||Number
1434268|NCT00978341|Secondary|Pharmacokinetic Evaluations of Pregabalin|Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses.|Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose|||||||
1434269|NCT00978341|Secondary|Neuropathic Pain Symptom Inventory (NPSI)|NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.|Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.|FAS; Combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Inter-Quartile Range|Median
1434270|NCT00978341|Secondary|Mechanical Pain Sensitivity Stimulus-Response Function|Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 –512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).|Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose|FAS; combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
1434271|NCT00978341|Secondary|Punctate Allodynia Area|Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]).|Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose|FAS; combined results for At-level and Below-level spinal cord injury.|||cm2||Standard Deviation|Mean
1434272|NCT00978341|Secondary|Dynamic Allodynia Pain Score|Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia.|Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose|FAS; Combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
1434273|NCT00978341|Secondary|Dynamic Allodynia Area|Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]).|Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,|FAS; Combined results for At-level and Below-level of spinal cord injury.|||cm2||Standard Deviation|Mean
1434274|NCT00978341|Secondary|Daily Pain Score|Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).|Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)|FAS; Combined results for At-level and Below-level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
1434275|NCT00978341|Primary|Present Pain Intensity Score|Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).|Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)|Full analysis set (FAS): those subjects who completed both periods of the study. Combined results for At-level and Below-level neuropathic pain; At-level: located within 2 dermatomes above or below the level of spinal cord injury; Below-level: located at least 3 dermatomes below the level of spinal cord injury.|||scores on scale||Standard Deviation|Mean
1434276|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
1434277|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
1434278|NCT00978120|Primary|Percentage of Participants With Seroprotection at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as a hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following two administrations of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
1437528|NCT00953212|Secondary|ICU Length of Stay||30 days||||days||Standard Deviation|Mean
1434281|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 41 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 41||||percentage of participants|||Number
1434282|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Severe Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
1434283|NCT00978120|Primary|Percentage of Participants With Seroconversion at Day 28 Following Two Administrations of Vaccination, Mild-Moderate Asthmatics|Seroconversion: The percentage of participants with a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following two administrations of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 28||||percentage of participants|||Number
1434284|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
1434285|NCT00978120|Secondary|Percentage of Participants With Seroprotection at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroprotection defined as hemagglutination inhibition assay (HAI) antibody titer of 1:40 or greater against influenza H1N1 2009 virus following a single administration of the H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
1434286|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Severe Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay(HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
1434287|NCT00978120|Secondary|Percentage of Participants With Seroconversion at Day 21 Following Single Administration of Vaccination, Mild-Moderate Asthmatics|Percentage of participants with seroconversion defined as a four-fold or greater hemagglutination inhibition assay (HAI) antibody titer increase compared to baseline against the novel influenza hemagglutinin type 1 and neuraminidase type 1 (H1N1) 2009 virus following a single administration of Novartis H1N1 vaccine at each dose, combined across age groups.|Days 1 to 21||||percentage of participants|||Number
1434288|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccination 2|Percentage of participants with asthma exacerbations within 8 days after vaccination 2. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 21 to 28||||percentage of participants|||Number
1434289|NCT00978120|Primary|Percentage of Participants With Asthma Exacerbations Status Post Vaccine 1|Percentage of participants with asthma exacerbations within 8 days after vaccination 1. Any of the following events are considered asthma exacerbation: Increase in the daily use of bronchodilator rescue medication for 2 consecutive days; an increase is defined as ≥6puffs of bronchodilator from a metered-dose inhaler or ≥2 uses of nebulized albuterol above average use reported in the two weeks prior to Visit 1. Increase in use of systemic corticosteroids or the addition of systemic corticosteroids to treatment regimen for asthma. Unscheduled use of health care for the treatment of asthma.|Days 1 to 8||||percentage of participants|||Number
1434290|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 2|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 2 by Dose Level Group.|Days 21 through 28||||percentage of participants|||Number
1434291|NCT00978120|Primary|Percentage of Participants With Reactogenicity Adverse Events (AEs) Status Post Vaccine 1|Percentage of participants with reactogenicity AEs, local (erythema, ecchymosis, induration, pain and tenderness at the injection sites) and systemic (feverishness, chills, fatigue, myalgias, arthralgias, headache and nausea), within 8 Days After Vaccination 1 by Dose Level Group.|Days 1 through 8||||percentage of participants|||Number
1434292|NCT00978120|Primary|Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination|Percentage of participants with serious adverse events (SAEs) attributed to vaccination, as determined by site investigators at the time of reporting.|Measured at Baseline Visit and Days 1, 8, 21, 28, 41, 80, 120, and 201||||percentage of participants|||Number
1434293|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on MFVDS by Facial Region|The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s respective mid-facial area score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments. The percentage of responders is categorized by facial region.|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.|||percentage of responders|||Number
1437529|NCT00953212|Secondary|Hospital Length of Stay||30 days||||days||Standard Deviation|Mean
1434294|NCT00978042|Secondary|Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)|The investigator evaluated the patient's overall mid-face volume using the GAIS 5-point scale where: 2=much improved to -2=much worse. To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on GAIS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.|6 months|Only those participants from the Modified-intent-to-treat (MITT) population randomized to the Treatment Arm who received treatment with available data are included in the analysis.|||Percentage of responders|||Number
1434295|NCT00978042|Secondary|Duration of Treatment Effect|Duration of treatment effect was determined by Kaplan-Meier (KM) product limit estimate of the percentage of participants in the treatment group that maintained at least a 1-point improvement in the overall mid-face volume deficit score on the Mid-Face Volume Deficit Scale (MFVDS) based on the average of the 2 blinded Evaluating Investigators’ assessments (with 95% Greenwood's Confidence Interval).|24 Months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to the treatment arm who received treatment and all participants randomized to no treatment control arm who received treatment, with data available for analysis."|||Percentage of participants||95% Confidence Interval|Number
1434296|NCT00978042|Primary|Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)|The primary effectiveness variable was responder rate for the treatment group. The investigator evaluated the volume deficit of the patient's face using the MFVDS 6-point scale where: 0=none (best) to 5=severe (worst). To be considered a “responder,” the average of the blinded, independent Evaluating Investigators’ assessments of the participant’s overall score on MFVDS at 6 months had to be improved (reduced) by ≥ 1 grade compared with the average of the Evaluating Investigator pre-treatment assessments.|6 months|"Participants from the Modified-intent-to-treat (MITT) population, all participants randomized to treatment who received treatment and all participants randomized to no treatment control arm, with data available for analysis."|||percentage of responders||95% Confidence Interval|Number
1434297|NCT00978029|Secondary|Proportion of Participants Who Discontinued Due to Adverse Events.|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 28|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
1434298|NCT00978029|Secondary|Proportion of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
1434299|NCT00978029|Secondary|Proportion of Participants Reporting Throat Irritation|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
1434300|NCT00978029|Secondary|Proportion of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
1434301|NCT00978029|Secondary|Proportion of Participants Reporting Oral Pruritus|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported.|Up to Day 42|ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
1434302|NCT00978029|Primary|The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 42|All subjects as treated (ASAT) consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.|||Proportion of Participants|||Number
1434303|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).|||percentage of patients|||Number
1434304|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434305|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||21 months (12-33 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434306|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized BMS ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).|||percentage of patients|||Number
1434307|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized BMS ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434308|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized BMS ITT||18 months (12-30 months post-index procedure)|All randomized BMS ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434309|NCT00977938|Secondary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|21 months (12-33 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥600 days after randomization or who had any adjudicated bleeding event at or before 630 days).|||percentage of patients|||Number
1434310|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|ST was assessed according to the Academic Research Consortium (ARC) definitions.|21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434311|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT||21 months (12-33 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 33 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434312|NCT00977938|Secondary|Definite or Probable Stent Thrombosis (ST) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.|||percentage of patients|||Number
1434313|NCT00977938|Secondary|MACCE (Death, Myocardial Infarction or Stroke) - Propensity Matched DES vs. BMS|Secondary powered endpoint|33 months (0-33 months post-index procedure)|A subsample created by matching BMS- to DES-treated patients exactly on prevalence of STEMI and then matching on remaining baseline characteristics via propensity score, using a caliper width of 0.10. A BMS-treated patient was matched to a variable number of DES-treated patients without replacement, up to a maximum of 8.|||percentage of patients|||Number
1434314|NCT00977938|Primary|GUSTO Severe or Moderate Bleeding - Randomized DES ITT|The primary safety endpoint was moderate or severe bleeding within randomized DES ITT patients between 12 and 30 months post procedure. Bleeding was assessed according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) criteria.|18 months (12-30 months post-index procedure)|Only patients who could be evaluated were included in this analysis (i.e., patients whose last contact date was ≥510 days after randomization or who had any adjudicated bleeding event at or before 540 days).|||percentage of patients|||Number
1434315|NCT00977938|Primary|Definite or Probable Stent Thrombosis (ST) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of definite or probable ST within randomized DES ITT patients between 12 and 30 months post procedure. ST was assessed according to the Academic Research Consortium (ARC) definitions.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434316|NCT00977938|Primary|MACCE (Death, Myocardial Infarction or Stroke) - Randomized DES ITT|The coprimary efficacy endpoints were the cumulative incidence of MACCE and the cumulative incidence of ARC definite or probable stent thrombosis within randomized DES ITT patients between 12 and 30 months post procedure.|18 months (12-30 months post-index procedure)|All randomized DES ITT patients; Patients were analyzed according to the treatment to which they were randomized (regardless of post-randomization compliance with the randomized treatment); Patients not experiencing the endpoint were censored at 30 months or at last known follow-up, whichever was earlier.|||percentage of patients (KM estimate)|||Number
1434317|NCT00977808|Primary|Occurrence of Hypoglycemic Episodes|Hypoglycemic events were defined as below 3.9 mmol/liter and the percentage of time within the range of 3.9 to 7.8 mmol/liter overnight (21:30 until 08:00) as measured by reference blood glucose (YSI or Beckman Glucose Analyzer).|Overnight (21:30 until 08:00)|Only participants who completed both study periods were considered for this assessment.|||Hypoglycemic Episodes|||Number
1434318|NCT00977769|Secondary|Bleeding|The calculated estimated blood loss from delivery until 2 h after intervention|120 minutes||||ml blood loss||Standard Deviation|Mean
1434319|NCT00977769|Primary|Arterial Blood Pressure|The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 min||||percentage change in arterial blood pres||95% Confidence Interval|Mean
1434320|NCT00977769|Primary|Cardiac Output|The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.|2.5 minutes||||percentage change in cardiac output||95% Confidence Interval|Mean
1434321|NCT00977704|Primary|Local and Systemic Adverse Events|"To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of:~All local adverse events as reported by healthcare professional~All systemic adverse events (related and unrelated)"|2-weeks|Primary object is to examine safety using descriptive statistics (frequency and percentage). Analysis was on the Intent to treat Population of all treated subjects, including those subjects for whom only incomplete data were available. No considerations (e.g. imputation) were made for missing data.|||percentage of participants|||Number
1434322|NCT00977665|Secondary|Total Number of Falls During the Study|Participants recorded each time they fell during the study in a diary.|Day 1 up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment, and who maintained diaries.|||falls||Inter-Quartile Range|Median
1434323|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Beck Depression Inventory Scale (BDI-II)|The Beck Depression Inventory (BDI-II), is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Participants are asked to pick the answer for each question that best describes the way they have been feeling in the past two weeks, including the day participants complete the questionnaire. Each question is rated on a scale of 0-3, with 0 meaning the participant does not feel the emotion described in the question, and 3 meaning the participant has extremely strong feelings. Total scale is 0 (no evidence of depression) to 63 (extreme depression). Negative change from baseline scores indicate improvement in level of depression.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1434324|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #1 (Speech Impairment), Question #2 (Swallowing Impairment) and Question #8 (Falling)|"UMSARS' questions are rated on a scale of 0=normal to 4=extreme impairment.~This endpoint reports the percentage of participants rated a 3 or worse. Rating 3 = Severely impaired speech (Question #1), swallowing (Question #2) or falling more frequently than once per week (Question #8)."|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||percentage of participants|||Number
1434325|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in the Montreal Cognitive Assessment Scale (MoCA) Scale|MoCA is a cognitive screening test which helps health professionals identify mild cognitive impairment. The total scale is 0 (significant cognitive impairment) to 30 (no impairment detected). Scores >=26 are considered normal. Positive change from baseline scores indicate improvement in cognition.|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1434326|NCT00977665|Secondary|Estimates for Time to Change in Anti-Parkinsonian or Anti-Orthostatis Hypotension Medications|"Change in anti-parkinsonian or anti-orthostatic hypotension medication is defined by at least one of the following events:~An addition of a new anti-parkinsonian or anti-orthostatic hypotension medication during study.~Dose modification of anti-parkinsonian or anti-orthostatic hypotension concomitant medications reflecting disease progression.~The event of interest, determined on a by patient basis, therefore, is the earliest event of the two events defined above. Otherwise, patient is right censored according to his/her study termination date.~Since less than 25% of participants had an event, median estimatation for time to change in medications is not possible."|Day 0 (baseline) to Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||days||95% Confidence Interval|Median
1434327|NCT00977665|Secondary|Change From Baseline to Week 12 in Total UMSARS Score for Symptomatic Effect|This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.|Day 0 (baseline), Week 12|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
1434328|NCT00977665|Secondary|Change From Baseline to Week 48 or Termination in UMSARS Subscores for Parts I, II and IV|UMSARS Part I is an historical review and scores symptoms of neurological and autonomic dysfunction with 12 items rated on a scale of 0 (normal) to 4 (extreme dysfunction). The full scale for Part 1 is therefore 0 (normal) to 48 (extreme dysfunction). Part II is a motor examination and has 14 items also rated on a scale of 0 to 4 for a full scale of 0 (normal) to 56 (extreme dysfunction). Part IV is a global disability scale with rates the extent of disease from 1 (normal) to 5 (severe disease).|Day 0 (baseline), Week 48 or termination visit|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1434329|NCT00977665|Secondary|Rate of Progression in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score From Baseline to Weeks 12-48|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment.~The rate of progression of atrophy is represented by the slope of change from baseline scores for visits between Weeks 12 and 48."|Day 0 (baseline), Weeks 12-48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale/week||Standard Error|Mean
1436032|NCT00964743|Primary|Number of Participants With Adverse Events (AEs)|Safety and tolerability of sorafenib with DepoCyt. Toxicities were to be reported using tables and descriptive statistics by type and grade. All patients were to be followed up until death.|6 Months|All participants|||participants|||Number
1434330|NCT00977665|Secondary|Change From Baseline to Week 48/Termination Visit in the Multiple System Atrophy (MSA) Health-related Quality of Life (QoL) Scale|"The Multiple System Atrophy Quality of Life questionnaire (MSA-QoL) is a self-reported questionnaire focusing on MSA-specific symptoms and has a scale ranging from 0 - 160, with 0= 'no problem' and 160= extreme problem."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1434331|NCT00977665|Secondary|Mean Score of the Composite Autonomic Symptom Scale Select (COMPASS_Select Change) at Week 48/Termination Visit|COMPASS_Select change is comprised of 5 of the 11 domains in the COMPASS scale: Orthostatic Intolerance, Bladder Disorder, Sweating, Vasomotor, and Sleep Disorder COMPASS_Select change has a range of -150 to 150, with -150 indicating symptoms are much better and 150 indicating symptoms are much worse.|48 weeks|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1434332|NCT00977665|Secondary|Percentage of Participants Who Achieved a Score of >=3 on the Unified Multiple System Atrophy Rating Scale (UMSARS) Question #7 Regarding Ambulation|UMSARS' Question #7 concerns the participant's ability to walk, rated on a scale of 0=normal to 4=cannot walk at all even with assistance. This endpoint counts participants rated a 3 or worse. Rating 3 = Severely impaired; assistance and/or walking aid needed occasionally.|up to week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||percentage of participants|||Number
1434333|NCT00977665|Secondary|Change From Baseline to Week 24 in Total Unified Multiple System Atrophy Rating Scale (UMSARS) Score|"The UMSARS is composed of 2 sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.~In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 24|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1434334|NCT00977665|Secondary|Clinical Global Impression Improvement (CGI-I) at Week 48/Termination Visit|"Outcome measures the investigator's clinical impression of the participants' improvement at Week 48 as compared to Week 12. CGI scale range from 1-7, with 1=very much improved, 4= no change, and 7=very much worse.~In order to maintain the overall (hypotheses about primary and key secondary endpoints) type I error at the 0.05 level an hierarchy will be employed as follows: If the primary endpoint will be found to be significant at a significance level of 0.05 then the first key secondary endpoint will be tested, if this endpoint will be found to be significant in a significance level of 0.05 then the second key secondary endpoint will be tested and so on. The 'key' secondary endpoints are outcomes 2-6."|Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
1434335|NCT00977665|Primary|Change From Baseline to Week 48/Termination Visit in the Total Unified Multiple System Atrophy Rating Scale (UMSARS Part I and II)|"This outcome represents the sum of 2 UMSARS sub-scales: Part I: Historical Review that includes 12 items and Part II: Motor Examination that includes 14 items. All items range from 0 to 4. Each subscale score is the sum of its items and the total UMSARS score is the sum of all 26 items. Hence the total UMSARS score can range from 0 to 104, with 0 meaning no impairment and 104 indicating severe impairment. Negative change from baseline scores indicate improvement.~In the case that 6 items or more (out of 26) were missing at a certain visit, the UMSARS score for that visit was assigned a missing value."|Day 0 (baseline), Week 48|Modified Intention-To-Treat Analysis Set (mITT): all randomized participants who took at least one dose of the study drug and who had at least one post-baseline efficacy assessment were included in the principal efficacy analysis, according to the treatment group to which they were originally assigned.|||units on a scale||Standard Error|Least Squares Mean
1434336|NCT00977613|Secondary|Overall Survival||after 6 months|||||||
1434337|NCT00977613|Secondary|Recurrence-free Survival||after 6 months|||||||
1434338|NCT00977613|Secondary|Disease-free Survival||after 6 months|||||||
1434339|NCT00977613|Primary|Number of Participants Who Maintained an Exercise Regimen Average of 18 Metabolic Units (MET) Per Week or Greater|One MET is the energy expenditure for sitting quietly for 1 hour. MET scores for walking were assigned based on the pace and duration reported. For other activities, a leisurely to moderate intensity score was selected. The scores for MET-hours per week for each activity were calculated from the reported hours per week engaged in that activity multiplied by the assigned MET score, and individual activities were summed to derive a total MET-hours per week.|6 months|34 of the 50 enrolled subjects had at least 6 months of follow-up. There was no evaluable data for the remaining 16 subjects.|||participants|||Number
1434340|NCT00977574|Secondary|The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment.|RECIST 1.1 was used to define objective tumor response. A complete response is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. A partial response is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. There can be no unequivocal progression of non-target lesions and no new lesions. Complete and partial responses are included in the objective tumor response rate. Confirmation of response was not required.|Imaging was done every 3 cycles and at any other time clinically indicated. Imaging was required every 9 weeks until progression or initiation on non protocol therapy. After 2 years of protocol therapy or follow up, CT scan or MRI was every 3 months|Enrolled patients with measurable disease|||Participants|||Count of Participants
1434341|NCT00977574|Secondary|The Median Duration of Overall Survival for Each of the Three Arms.|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Time from date of study entry to time of death or the date of last contact, assessed up to 5 years|All enrolled patients|||months||95% Confidence Interval|Median
1434343|NCT00977574|Primary|Number of Participants Who Progressed or Died by 25 Months From Enrollment|PFS (Progression free survival) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. Patients with a status of alive, progression-free are censored at their date of last follow-up. To lessen the potential for bias in the progression evaluation times between treatment arms and historical controls, progression/death times will be grouped over 6 18-week time intervals. Progressions are carried forward to the end of the interval. All progressions or deaths occurring after the 6th 18-week interval are censored at 25 months for this analysis. Study NCT00977574|at 25 months|All enrolled patients|||Participants|||Count of Participants
1434344|NCT00977561|Secondary|Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs|Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs|Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)|No analysis of total CTCs and IGF-IR-expressing CTCs was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434345|NCT00977561|Secondary|Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers||Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)|No analysis for serum circulating IGF pathway related markers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434346|NCT00977561|Secondary|Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway||Baseline prior to dosing|No analysis of tumor biomarkers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434347|NCT00977561|Secondary|Numeric Rating Scale (NRS) Score|"The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess worst pain severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for NRS score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434348|NCT00977561|Secondary|Cancer Dyspnea Scale (CDS) Score|"The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 Not at All to 5 Very Much)."|Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression|No analysis for cancer dyspnea scale score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434349|NCT00977561|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab|Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose|No analysis of ADA response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434350|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Etoposide||Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of PK parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434351|NCT00977561|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion|No analysis of pharmacokinetics (PK) parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434352|NCT00977561|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmin for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434353|NCT00977561|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose|No analysis of Cmax for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434799|NCT00975650|Primary|Serum Dihydrotestosterone Ln-Cmax||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
1434354|NCT00977561|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.|Baseline up to follow-up (90 days post dose)|All randomized participants who received at least one dose of any agent of the combination were included in the safety analysis.|||participants|||Number
1434355|NCT00977561|Secondary|Overall Survival (OS)|Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].|Every 3 months until death or 12 months from the date the last participant was randomized|No analysis of overall survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434356|NCT00977561|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of objective response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434357|NCT00977561|Primary|Progression-Free Survival (PFS)|Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].|Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression|No analysis of progression-free survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.||||||
1434358|NCT00977548|Secondary|Leukemia Free Survival (LFS)|LFS: Survival without evidence of relapse at any time post-transplant. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||months||95% Confidence Interval|Median
1434359|NCT00977548|Secondary|Median Progression Free Survival (PFS)|PFS: The time elapsed between treatment initiation and tumor progression or death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis. Disease Progression is defined using International Working Group (IWG) Response Criteria for MDS, as at least 50% decrement from maximum remission/response levels in granulocytes or platelets; reduction in hemoglobin (Hgb) concentration by ≥ 2 g/dL; transfusion dependence.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||months||95% Confidence Interval|Median
1434360|NCT00977548|Secondary|Median Overall Survival (OS)|OS: The time from randomization until death from any cause. Kaplan-Meier estimates were used for secondary endpoint analysis.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||months||95% Confidence Interval|Median
1434361|NCT00977548|Primary|Combined Overall Response Rate (ORR)|Best Response Categories: Marrow complete response (CR), Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment; Hematological improvement (HI), Hgb increase by ≥ 1.5 g/dL, Absolute increase of ≥ 30 x 10^9/L for patients starting with > 20 x 10^9/L, At least 100% increase and an absolute increase of > 0.5 x 10^9/L, as defined by the International Working Group (IWG) 2006 criteria.|Up to 21 Months|All evaluable participants. Nine patients were not evaluable for response (withdrew consent or off study due to adverse event before first evaluation).|||participants|||Number
1434362|NCT00977470|Other Pre-specified|Percent of Participants in Which FMISO-PET ([18F]-Fluoromisonidazole-positron Emission Tomography) is Able to Detect and Quantify Changes in Tumor Hypoxia After Erlotinib.|[18F]-FMISO-PET/CT was performed on a 64-slice PET/CT scanner and tracer uptake was assessed using SUV (standardized uptake value), normalizing the radioactivity measured in tissue by the injected dose and the body weight of the patient. Mean and maximum SUV and threshold volume of FMISO uptake were measured to quantify the extent of hypoxia in the primary tumor. Imaging was performed before and after initiation of therapy with erlotinib.|12 weeks|Only 2 participants were enrolled in this pilot companion study|||Participants|||Count of Participants
1434363|NCT00977470|Other Pre-specified|EGFR Mutational Status|Correlation of molecular and genetic tumor characteristics with disease response. Genomic DNA will be extracted from tumor tissue and direct sequencing analysis will be performed to identify additional mutations.|2 years|Tumor tissue analysis was not performed for this correlative outcome.||||||
1434364|NCT00977470|Other Pre-specified|Circulating Tumor Cell Quantification|Serial circulating tumor cell (CTC) analyses will be performed on peripheral blood and correlated with disease response.|Until disease progression (median of 10.8 months)|Due to technical reasons, this assay was not ready and therefore circulating tumor cell analysis was not done.||||||
1434365|NCT00977470|Secondary|Overall Survival of Patients Treated With Erlotinib and With Erlotinib/HCQ||Until death||2018-01-31|01/2018||||
1437530|NCT00953212|Secondary|Number of Participants With Mortality|Mortality measured within length of hospital stay|30 days||||Participants|||Count of Participants
1434366|NCT00977470|Secondary|Objective Tumor Response Rate Following Treatment With Erlotinib and With Erlotinib/HCQ.|"Response is assessed via spiral CT scan, done at baseline and after every 2 cycles of study treatment. Standard RECIST (Response Evaluation Criteria in Solid Tumors) was used. Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in the size of target lesions, as compared to baseline; Progressive Disease (PD) = at least at 20% increase in the size of target lesions, or the appearance of one or more new lesions; Stable Disease (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.~Response rate = CR + PR. Disease control rate = CR + PR + SD"|2 years|1 participant in each arm (2 participants total) did not have any scans done after baseline and therefore response could not be assessed.|||Participants|||Count of Participants
1434367|NCT00977470|Secondary|Treatment Related Toxicity, > 10% Frequency, Any Grade|To evaluate the safety of treatment with erlotinib with and without hydroxychloroquine (HCQ). All participants receiving study treatment were evaluated for safety. Parameters included laboratory tests, hematological abnormalities, physical exam findings and spontaneous reports of adverse events reported by participants. Toxicities were evaluated and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = fatal.|2 years||||Participants|||Count of Participants
1434368|NCT00977470|Primary|Nine-month Progression-free Survival Rate|This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus hydroxychloroquine (HCQ) arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test. Progression is defined as at least a 20% increase in the size of existing lesions or the appearance of one or more new lesions.|Nine months||||percentage of participants||95% Confidence Interval|Number
1434369|NCT00977470|Primary|Median Progression Free Survival|A measure of progression-free survival in patients with advanced non small-cell lung cancer (NSCLC) and EGFR mutations treated with erlotinib as compared with patients treated with erlotinib plus hydroxychloroquine (HCQ). Disease progression is defined as at least a 20% increase in the sum of the longest diameter of target lesions, as seen on CT scan, or the appearance of one or more new lesions on CT scan.|From start of treatment until report of disease progression, assessed up to 10 years.||||months||Full Range|Median
1434370|NCT00977379|Secondary|Absolute Change From Baseline in Mini Mental State (MMS) Total Score|MMS was an 11-question measure that tested five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Four items were scored on a scale of 0 to 1; 1 item was scored on a scale of 0 to 2; 3 items were scored on a scale of 0 to 3; and 3 items were scored on a scale of 0 to 5. MMS total score was obtained by adding the scores of all individual items and ranged from 0 to 30, where higher scores indicate better cognitive state.|Baseline, Up to end of Treatment (up to 10.6 months overall)|ITT population. Here, number of participants analyzed = participants evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
1434371|NCT00977379|Secondary|Overall Survival (OS)|OS was defined as the time from the start of study treatment to date of death due to any cause. OS was assessed using Kaplan-Meier analysis.|Baseline until death (up to approximately 1 year 5.5 months overall)|ITT population.|||months||95% Confidence Interval|Median
1434372|NCT00977379|Secondary|Time to Progression, Assessed by Investigator According to MRI and CT|Time to progression was defined as the time from start of study treatment to first documentation of PD or death due to tumor (CNS or extra-cranial). PD was assessed by MRI or CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS or extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS or extra-cranial lesions and/or unequivocal progression of existing CNS or extra-cranial lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.|||months||Full Range|Median
1434373|NCT00977379|Secondary|Time to Extra-cranial Disease Progression, Assessed by Investigator According to CT|Time to extra-cranial progression was defined as the time from start of study treatment to first documentation of PD or death due to extra-cranial lesions. PD was assessed by CT according to RECIST. PD: a 20% or greater increase in the sum of the LD of extra-cranial lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more extra-cranial lesions and/or unequivocal progression of existing extra-cranial lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.|||months||Full Range|Median
1434374|NCT00977379|Secondary|Percentage of Participants With Objective Extra-cranial Disease Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to CT|Objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.|||percentage of participants|||Number
1434375|NCT00977379|Secondary|Percentage of Participants With Best Objective Extra-cranial Disease Response, Assessed by Investigator According to Computed Tomography (CT)|Best objective extra-cranial response was defined as having CR or PR for extra-cranial lesions, assessed by CT using RECIST. CR: disappearance of all extra-cranial lesions. PR: >/=30 % decrease in sum of LD of extra-cranial lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.|||percentage of participants|||Number
1434517|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434376|NCT00977379|Secondary|Time to CNS Progression, Assessed by Investigator According to MRI|Time to CNS progression was defined as the time from start of study treatment to first documentation of PD or death due to CNS metastasis. PD was assessed by contrast-enhanced MRI according to RECIST. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.|||months||Full Range|Median
1434377|NCT00977379|Secondary|Duration of CNS Response, Assessed by Investigator According to MRI|Duration of CNS response was defined as the time from first documented cranial CR or PR (whichever was recorded first) until the first date CNS recurrence or progression was documented as assessed by contrast-enhanced MRI according to RECIST criteria but without exam for response confirmation. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population. Here, number of participants analyzed = participants having had a CR or PR during the study.|||months||Full Range|Median
1434378|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Investigator According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.|||percentage of participants|||Number
1434379|NCT00977379|Secondary|Percentage of Participants With Clinical Benefit, Assessed by Investigator According to MRI|Clinical benefit was defined as having CR, PR, or stable disease (SD), assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30 % decrease in sum of LD of CNS lesions taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum LD since treatment started. PD: a 20% or greater increase in the sum of the LD of CNS lesions taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more CNS lesions and/or unequivocal progression of existing CNS lesions.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.|||percentage of participants|||Number
1434380|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI in 3 Dimension|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by 3 dimensional MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|The data for this outcome was not collected as per changes in planned analysis because sufficient information on the method used was not available.||||||
1434381|NCT00977379|Secondary|Percentage of Participants With Best Objective CNS Response, Assessed by Investigator According to MRI|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.|||percentage of participants|||Number
1434382|NCT00977379|Secondary|Percentage of Participants With Objective CNS Response at 4 Weeks After Completion of WBRT, Assessed by Centralized Independent Expert According to MRI|Objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first up to 4 weeks after completion of WBRT (up to approximately 7 weeks)|ITT population.|||percentage of participants|||Number
1434383|NCT00977379|Primary|Percentage of Participants With Best Objective CNS Response, Assessed by Centralized Independent Expert According to MRI - Per-Protocol (PP) Population|Best objective CNS response was defined as having CR or PR for CNS metastasis, assessed by contrast-enhanced MRI using RECIST. CR: disappearance of all CNS lesions. PR: >/=30% decrease in sum of LD of CNS lesions taking as reference the baseline sum LD.|Baseline until PD, unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|PP population included all ITT population participants excluding participants with following major protocol violations: inclusion and exclusion criteria not met; intake of prohibited treatment, protocol design and/or visit dates not respected; and missing values for main criterion without premature withdrawal.|||percentage of participants|||Number
1434406|NCT00977106|Secondary|DAS40 During the Open Treatment Period|DAS40 was calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate, and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS40 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1434384|NCT00977379|Primary|Percentage of Participants With Best Objective Central Nervous System (CNS) Response, Assessed by Centralized Independent Expert According to Magnetic Resonance Imaging (MRI) - Intent-to-Treat (ITT) Population|Best objective CNS response was defined as having complete response (CR) or partial response (PR) for CNS metastasis, assessed by contrast-enhanced MRI using response evaluation criteria in solid tumors (RECIST). CR: disappearance of all CNS lesions. PR: greater than or equal to (>/=) 30 percent (%) decrease in sum of longest diameters (LD) of CNS lesions taking as reference the baseline sum LD.|Baseline until disease progression (PD), unacceptable toxicity, withdrawal of consent, change of therapeutic strategy (for arm “WBRT Followed by Standard of Care” only), or death, whichever occurred first (up to approximately 1 year 5.5 months overall)|ITT population.|||percentage of participants|||Number
1434385|NCT00977314|Secondary|Measure of Benefit of SoundBite Using Abbreviated Profile of Hearing Aid Benefit (APHAB).|The measure of the benefit of the device was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB), a 24-item self-assessment inventory in which the amount of difficulty in everyday situations is reported with larger numbers indicating more difficulty. Device benefit is calculated by subtracting the score obtained after using a device from the score obtained before using the device. A software program is utilized to score the APHAB and results are compared a different time points. The APHAB is well characterized and broadly used as a quantifiable measurement of device benefit. The APHAB benefit scores can range from -99 (treatment worse than no treatment) to +99 (treatment better than no treatment)|30 days||||Global Benefit Score||Standard Deviation|Mean
1434386|NCT00977314|Primary|Efficacy: Ability to Understand Speech in Noise|The primary efficacy outcome was a measure of the ability to understand speech in noise while wearing the device compared with not wearing the device. The Hearing in Noise Test (HINT) was utilized for this measure as it is the most widely used test for SSD devices. An improvement in HINT score is indicated as a negative (-) dB value change. A more negative (-dB) value indicates an improvement in understanding speech in noise. An improvement in a HINT score of -1 dB is equivalent to a 10% improvement in the ability to understand speech in noise and is likely of clinical benefit. The scores are calculated as HINT Advantage (aided compared with unaided) which depict the differences of using a device as compared to not wearing a device.|Day 1, Day 30||||dB||Standard Deviation|Mean
1434387|NCT00977314|Primary|Incidence of Device- and Procedure-related Adverse Events at 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:~Comprehensive Medical evaluation at Enrollment and at Termination Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed Comprehensive Audiological evaluation at Enrollment and Termination."|30 days||||participants|||Number
1434388|NCT00977197|Secondary|Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|baseline, week 12|Intent to Treat analysis|||participants|||Number
1434389|NCT00977197|Secondary|Mean Bloating BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434390|NCT00977197|Secondary|Mean Diarrhea BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434391|NCT00977197|Secondary|Mean Constipation BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434392|NCT00977197|Secondary|Mean Overall Severity BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434393|NCT00977197|Secondary|Mean Pain BSS Score at Week 12|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Week 12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434395|NCT00977197|Secondary|Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12)|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434396|NCT00977197|Secondary|Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434397|NCT00977197|Secondary|Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|Weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434398|NCT00977197|Secondary|Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire.|||units on a scale||Standard Deviation|Mean
1434399|NCT00977197|Primary|Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)|The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.|weeks 9-12|Intent to treat analysis|||units on a scale||Standard Deviation|Mean
1434400|NCT00977184|Secondary|Activities of Daily Living UPDRS|The Activities of Daily Living Unified Parkinson's Disease Rating Scale (ADL UPDRS) is a self evaluation of the activities of daily living. The following variables are rated: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed, falling, freezing when walking, walking, tremor and sensory complaints. Each variable is rated on a scale of 0 (normal) to 4 (severe impairment). A total score for the ADL UPDRS ranges from 0 (no impairment) to 52 (severe impairment).|Baseline, 1 day post rTMS|Intent to treat|||units on a scale||Standard Deviation|Mean
1434401|NCT00977184|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administered at baseline and at 1 day post rTMS or sham. Subjects were assessed on medication and off medication.|Baseline, 1 day post rTMS|Intent to treat.|||units on a scale||Standard Deviation|Mean
1434402|NCT00977184|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|Baseline, 1 day post rTMS|Intent to treat|||units on a scale||Standard Deviation|Mean
1434403|NCT00977184|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|Baseline, 1 day post rTMS||||seconds||Standard Deviation|Mean
1434404|NCT00977184|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real rTMS and sham rTMS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline and 1 day post intervention.|Baseline, 1 day post rTMS|Intent to treat|||seconds||Standard Deviation|Mean
1434405|NCT00977171|Primary|Patient Global Impression of Improvement|The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.|Baseline to end of 12 week treatment period|3 patients enrolled in the study prior to it being stopped due to difficulty enrolling patients.|||units on a scale||Standard Deviation|Mean
1447223|NCT00874250|Primary|The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment||Treatment through 1 month post treatment||||participants|||Number
1434407|NCT00977106|Secondary|Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period|DAS40 calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
1434408|NCT00977106|Secondary|DAS28 During the Open Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1434409|NCT00977106|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
1434410|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) for a total possible score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
1434411|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434412|NCT00977106|Secondary|SJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||swollen joints||Standard Deviation|Mean
1434413|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints) . Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||swollen joints||Standard Deviation|Mean
1434414|NCT00977106|Secondary|Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434415|NCT00977106|Secondary|Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||swollen joints||Standard Deviation|Mean
1434416|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Open Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
1434417|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.|Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434418|NCT00977106|Secondary|TJC Based on 40-Joint Count During the Double-Blind Treatment Period|Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||tender joints||Standard Deviation|Mean
1434419|NCT00977106|Secondary|TJC Based on 28-Joint Count During the Open Treatment Period|Twenty-eight joints were assessed for tenderness and joints were classified as tender (1)/not tender (0), giving a total possible tender joint count score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.|Baseline and Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||tender joints||Standard Deviation|Mean
1434420|NCT00977106|Secondary|Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434421|NCT00977106|Secondary|Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period|Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||tender joints||Standard Deviation|Mean
1434422|NCT00977106|Secondary|Hemoglobin Concentration During the Open Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as g/dL.|Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
1434423|NCT00977106|Secondary|Hemoglobin Concentration During the Double-Blind Treatment Period|Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as grams per deciliter (g/dL).|Baseline and Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
1434424|NCT00977106|Secondary|FACIT-F During the Open Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1434425|NCT00977106|Secondary|Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Week 1 and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1434426|NCT00977106|Secondary|Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Day 0, Week 1, and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1434427|NCT00977106|Secondary|HAQ-DI During the Open Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
1436791|NCT00959647|Primary|Percentage of Participants Who Discontinued Treatment Due to an Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.|||Percentage of participants|||Number
1434428|NCT00977106|Secondary|HAQ-DI During the Double-Blind Treatment Period|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Screening and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1434429|NCT00977106|Secondary|Weekly Methotrexate (MTX) Dose|Before entering the study, participants had to be treated with MTX for at least 12 weeks and at a stable dose for at least 8 weeks before the screening visit (10-25 mg per week [mg/week] of oral or parenteral MTX). During the study, treatment with MTX had to be stable during the first month and then could be continued or modified, at the investigator’s discretion.|Baseline and Weeks 24 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/week||Standard Deviation|Mean
1434430|NCT00977106|Secondary|Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period|S-OGP is a biological marker of bone and cartilage metabolism measured as picomoles per liter (pmol/L). Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12 and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||pmol/L||Standard Deviation|Mean
1434431|NCT00977106|Secondary|Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period|S-PIIINP, S-CTX-I, and S-PINP are biological markers of bone and cartilage metabolism. Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline and Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||ng/mL||Standard Deviation|Mean
1434432|NCT00977106|Secondary|S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period|S-Sclerostin and P-Dkk1 are biological markers of bone and cartilage metabolism measured as picograms/milliliter (pg/mL). Baseline is the closest value plus or minus (+/-) 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.|Baseline, Weeks 12, 24, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||pg/mL||Standard Deviation|Mean
1434433|NCT00977106|Secondary|Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period||Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1434434|NCT00977106|Secondary|Bone Mineral Density|To describe bone mineral density (BMD), standardized values were calculated for lumbar spine, hip, femoral neck, and trochanter, taking into account the type of Dual energy X ray absorptiometry (DXA) used. All DXA at baseline were taken into account (done from before screening to Week 8). DXA at end of study were taken into account if they were done after at least 6 infusions of tocilizumab. Values were measured in milligrams per square centimeter (mg/cm^2).|Baseline and Week 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/cm^2||Standard Deviation|Mean
1434435|NCT00977106|Secondary|Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation. If baseline value was equal to 0, it was replaced by 0.1 to calculate the change from baseline.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434436|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Double-Blind Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mg/L||Standard Deviation|Mean
1434437|NCT00977106|Secondary|Beta 2 Microglobulin Levels During the Open Treatment Period|Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population;n=number of participants assessed for the specified parameter at a given visit.|||mcg/mL||Standard Deviation|Mean
1434438|NCT00977106|Secondary|Serum Amyloid A Component During the Open Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation measured in mg/L. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
1434439|NCT00977106|Secondary|Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation. A negative change from baseline indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434440|NCT00977106|Secondary|Serum Amyloid A Component During the Double-Blind Treatment Period|Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L. A reduction in SAA indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mg/L||Standard Deviation|Mean
1441667|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
1434441|NCT00977106|Secondary|C- Reactive Protein During the Open Treatment Period|C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||ng/L||Standard Deviation|Mean
1434442|NCT00977106|Secondary|Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation. Negative changes from baseline indicate improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434443|NCT00977106|Secondary|C-Reactive Protein During the Double-Blind Treatment Period|C-Reactive protein (CRP) is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). A reduction in CRP indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||ng/mL||Standard Deviation|Mean
1434444|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Open Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm/hr. A reduction in ESR indicates improvement. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.|Baseline, Weeks 12, 24, 36, and 48|One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1434445|NCT00977106|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment|Erythrocyte sedimentation rate is a biological marker of inflammation. A negative change indicates improvement.|Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434446|NCT00977106|Secondary|Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period|Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr). A reduction in ESR indicates improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm/hr||Standard Deviation|Mean
1434447|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage change from baseline.|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434448|NCT00977106|Secondary|Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage (%) change from baseline.|Weeks 12, 24, and 48|One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||percent change||Standard Deviation|Mean
1434449|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Negative change from baseline indicated improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
1434460|NCT00977080|Secondary|Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
1434450|NCT00977106|Secondary|Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound|Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from “0” to “3”, for each of 40 joints (5 metacarpal phalangeal [MCP; left and right] joints, 5 proximal interphalangeal [PIP; left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 metatarsal phalangeal [MTP; left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120. A score of 0 indicated no damage and a score of 120 indicated most severe damage. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. A negative change from baseline indicated improvement.|Baseline, Weeks 1 and 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||units on a scale||Standard Deviation|Mean
1434451|NCT00977106|Secondary|Patient Global Assessment of Pain During the Open Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed at a specific visit|||mm||Standard Deviation|Mean
1434452|NCT00977106|Secondary|Patient Global Assessment of Pain During the Double-Blind Treatment Period|Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
1434453|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Open Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36, and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
1434454|NCT00977106|Secondary|Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period|Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline and Week 4|ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
1434455|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Open Treatment Period|Participants were asked to rate their assessment of disease activity using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 12, 24, 36 and 48|ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
1434456|NCT00977106|Secondary|Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period|Participants were asked to rate their assessment of disease activity using a visual analog scale (VAS) of 0 to 100 millimeters (mm), where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.|Baseline, Weeks 1 and 4|ITT Population; number (n) = number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.|||mm||Standard Deviation|Mean
1434457|NCT00977106|Primary|Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.|Week 4|ITT Population|||percentage of participants|||Number
1434458|NCT00977080|Secondary|Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was > 10.5 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
1434459|NCT00977080|Secondary|Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28)|Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was < 8.4 mg/dL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
1434461|NCT00977080|Secondary|Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
1434462|NCT00977080|Secondary|Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
1434463|NCT00977080|Primary|The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28).|iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted.|Weeks 21 to 28|Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28)|||Participants|||Number
1434464|NCT00976989|Secondary|Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures|Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.|From baseline up to approximately 3.5 years|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable.|||percentage (ejection fraction)||Standard Deviation|Mean
1434465|NCT00976989|Secondary|Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events|Percentage of participants with LVEF events without signs or symptoms of cardiac events.|From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.|||percentage of participants|||Number
1434466|NCT00976989|Secondary|Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)|Percentage of participants with signs or symptoms of cardiac events.|From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)|Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.|||percentage of participants|||Number
1434467|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event|Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.|||percentage of participants|||Number
1434468|NCT00976989|Secondary|Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event|The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.|||percentage of participants|||Number
1434469|NCT00976989|Secondary|Efficacy: Percentage of Participants Without an Overall Survival (OS) Event|Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.|From baseline to end of study up to 5 years|ITT population included all participants who were randomized to treatment.|||percentage of participants|||Number
1434470|NCT00976989|Secondary|Efficacy: Percentage of Participants Achieving Breast Conserving Surgery|This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.|At approximately 18 weeks|Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.|||percentage of participants|||Number
1434471|NCT00976989|Secondary|Efficacy: Time to Clinical Response|Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|Up to 18 weeks|ITT population included all participants who were randomized to treatment.|||weeks||95% Confidence Interval|Median
1435286|NCT00972543|Secondary|Haematology Laboratory Assessments - Red Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1434472|NCT00976989|Secondary|Efficacy: Clinical Response Rate|Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions.|During each 3-week cycle of 6 total cycles: up to 18 weeks|ITT population included all participants who were randomized to treatment.|||percentage of participants|||Number
1434473|NCT00976989|Secondary|Efficacy: Percentage of Participants With Complete Pathological Response (pCR)|pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.|At surgery, after 18 weeks (6 cycles) of treatment|Intent to treat (ITT) population included all participants who were randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
1434474|NCT00976989|Primary|Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period|Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of <50% during the pre-operative (neoadjuvant) period.|From baseline up to approximately 18 weeks|Safety population included all participants who were randomized and received study drug.|||percentage of participants|||Number
1434475|NCT00976989|Primary|Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator|Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.|From baseline up to approximately 3.5 years|Safety population included all participants who were randomized and received study drug.|||percentage of participants|||Number
1434476|NCT00976950|Secondary|Change in CD4+ Cell Count From Baseline at Week 48||48 weeks|Treated set with with non-missing data at the visit|||cells/mm^3||Standard Deviation|Mean
1434477|NCT00976950|Secondary|Virologic Response|Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.|48 weeks|Treated set (TS), defined as patients treated with Aptivus|||Number of participants|||Number
1434478|NCT00976950|Primary|Number of Patients Reporting Adverse Events (AE)|Any type of adverse events|48 weeks|Treated set (TS), defined as patients treated with Aptivus|||Participants|||Number
1434479|NCT00976937|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1434480|NCT00976937|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||ratio||Standard Error|Least Squares Mean
1434481|NCT00976937|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1434482|NCT00976937|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1434483|NCT00976937|Other Pre-specified|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1434484|NCT00976937|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1434485|NCT00976937|Secondary|Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment–Beta (HOMA-beta) at Week 24|HOMA-beta was derived from FPG and FPI as: (20*FPI [micro units/milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated for HOMA-beta by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||percentage of normal beta cells function||Standard Error|Least Squares Mean
1434486|NCT00976937|Secondary|Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24|HOMA-IR was derived from FPG and FPI as: (FPI [micro units per milliliter]*FPG [mmol/L]) divided by 22.5. Change was calculated for HOMA-IR by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-IR assessment during on-treatment period.|||mU * mmol/L^2||Standard Error|Least Squares Mean
1434487|NCT00976937|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|Change was calculated for fasting proinsulin and 2-hour postprandial proinsulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of the study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
1434488|NCT00976937|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|Change was calculated for fasting glucagon and 2-hour postprandial glucagon by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||ng/L||Standard Error|Least Squares Mean
1434489|NCT00976937|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|Change was calculated for fasting C-peptide and 2-hour postprandial C-peptide by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||nmol/L||Standard Error|Least Squares Mean
1434490|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated for fasting plasma insulin and 2-hour post prandial plasma insulin by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
1434491|NCT00976937|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1434492|NCT00976937|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1434493|NCT00976937|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1434494|NCT00976937|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1434495|NCT00976937|Secondary|Absolute Change From Baseline in HbA1c at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1434496|NCT00976937|Primary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24|Percentage of patients who met both criteria (HbA1c <7% at Week 24 and at least 5% weight loss from baseline at Week 24) is reported. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest.|Week 24|mITT population included randomized patients who received at least 1 dose of study drug. Missing data was imputed using Last observation carried forward (LOCF).|||percentage of participants|||Number
1434497|NCT00976911|Secondary|European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)|The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.|Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)|ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit.|||percentage of participants||95% Confidence Interval|Number
1434498|NCT00976911|Secondary|Overall Survival (Data Cutoff 25 January 2013)|Duration of overall survival was defined as the time from randomization to death of any cause. Kaplan-Meier methodology was used. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. 95% CI was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population; only participants who died were included in the analysis.|||months||95% Confidence Interval|Median
1434499|NCT00976911|Primary|Progression Free Survival (PFS; Data Cutoff 14 November 2011)|PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted. Time from randomization to occurrence of disease progression or death was measured in months. An event was defined as the earliest progressive disease or death that occurred on or before the cutoff date (14 November 2011), regardless of start of nonprotocol specified anti-cancer therapy or the bevacizumab monotherapy. Disease progression was assessed by investigator according to RECIST or by symptom deterioration, and could not be declared on the basis of rising cancer antigen 125 (CA125) levels alone. Kaplan-Meier methodology was used. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with an event of progression or death were included in the analysis|||months||95% Confidence Interval|Median
1434500|NCT00976911|Secondary|Percentage of Participants Who Died (Data Cutoff 25 January 2013)||Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 25 January 2013|ITT Population|||percentage of participants|||Number
1434501|NCT00976911|Secondary|Duration of Objective Response (Data Cutoff 14 November 2011)|For randomized participants who achieved an objective response per modified RECIST, duration of objective response was defined as the time from the date of the first occurrence of a CR or PR (whichever occurred first) until the date that progressive disease or death was documented (whichever occurred first). Participants who had an objective response and did not experience disease progression or death by the time of analysis were censored at the time of the last tumor assessment. Summaries of duration of objective response (median and percentiles) were estimated from Kaplan−Meier curves. 95% CI for duration of objective response was computed using the method of Brookmeyer and Crowley.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with a best overall confirmed response of CR or PR were included in the analysis.|||months||95% Confidence Interval|Median
1434502|NCT00976911|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) Per Modified RECIST (Data Cutoff 14 November 2011)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. 95% CI computed using the normal approximation to the binomial distribution.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population; only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1434503|NCT00976911|Primary|Percentage of Participants With Disease Progression or Death (Data Cutoff 14 November 2011)|Progression free survival was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurs first. Progression was based on tumour assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (for participants with measurable disease), and for those with non-measurable disease presence or absence of lesions was noted.|Screening Visit, Every 8 weeks (or 9 weeks if receiving topotecan) until progression reported between day of first participant randomized (29 October 2009) until cutoff date of 14 November 2011|ITT Population: All participants randomized to study treatment, irrespective of whether or not the assigned treatment was actually received. For all efficacy analyses, participants were grouped according to the treatment assigned at randomization|||percentage of participants|||Number
1434504|NCT00976898|Secondary|Patterns of Failure|A summary of the patterns of treatment failure, shown as the number of participants that fall into each category at the end of study follow-up|2 years||||Participants|||Count of Participants
1434505|NCT00976898|Secondary|Number of Participants With Treatment Related Adverse Events ≥ Grade 3|Summary of the proton radiation related grade 3 or greater adverse events that participants experienced. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v3).|2 years||||Participants|||Count of Participants
1434506|NCT00976898|Primary|Median Overall Survival|The median survival time in months as measured from the start of treatment until death due to any cause or until the participants is censored. Participants are censored at the date of their last follow-up.|5 years||||Months||95% Confidence Interval|Median
1434507|NCT00976898|Primary|2 Year Local Control Rate|The percentage of participants with local control after two years as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The duration of control was measured from the start of treatment. Local control is the absence of local failure. Local Failure is defined as evidence of tumor growth/regrowth in any direction beyond that present of the pre-treatment imaging studies in the treated lesion(s).|2 years||||percentage of participants||95% Confidence Interval|Number
1434508|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434509|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 182 days (Days 0-181) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434510|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 42 days (Day 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434511|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - First Analysis|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434512|NCT00976820|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434513|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434514|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 182 days (Days 0-181) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434515|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434516|NCT00976820|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1437570|NCT00953017|Secondary|Patient Satisfaction With the Prep Measured by 5 Point Likert Scale|patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)|measured at check in to colonoscopy||||units on a scale||Standard Deviation|Mean
1434518|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Throughout the entire study period (Day 0 - Day 385)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434519|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 182 days (Days 0-181) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434520|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434521|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 41 days (Days 0-40) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434522|NCT00976820|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs) – Preliminary Analysis|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434523|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 84 days (Days 0-83) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434524|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – Second Analysis|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 41 days (Days 0-40) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434525|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – First Analysis|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 42 days (Days 0-41) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434526|NCT00976820|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) – Preliminary Analysis|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 21 days (Days 0-20) post vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434527|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 182|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434549|NCT00976820|Secondary|Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434528|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 182|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434529|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7, at Day 21 and at Day 42|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434530|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7 and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434531|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7, at Day 21 and at Day 42|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434532|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities - First Analysis|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7, at Day 21 and at Day 42|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434533|NCT00976820|Secondary|Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis|Biochemical parameters assessed for lab abnormalities were alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin [BLR], bilirubin conjugated/direct [BCD], creatinine [CRE] and blood urea nitrogen [BUN]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7 and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434534|NCT00976820|Secondary|Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis|Among haematological parameters assessed were basophils [BAS], eosinophils [EOS], hematocrit [HCT], hemoglobin level [HGB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelet count [PLC], red blood cells [RBC] and white blood cells [WBC]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.|At Day 0 (PRE), at Day 7 and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434535|NCT00976820|Secondary|Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434536|NCT00976820|Secondary|Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434537|NCT00976820|Secondary|Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434538|NCT00976820|Secondary|Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434539|NCT00976820|Secondary|Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434540|NCT00976820|Secondary|Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434541|NCT00976820|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434542|NCT00976820|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434543|NCT00976820|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434544|NCT00976820|Secondary|Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations|Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434545|NCT00976820|Secondary|Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations|Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434546|NCT00976820|Secondary|Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1434547|NCT00976820|Secondary|Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434548|NCT00976820|Secondary|Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1434550|NCT00976820|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
1434551|NCT00976820|Secondary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0 (PRE) and at Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434552|NCT00976820|Secondary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434553|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1434554|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1434555|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1434556|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1434557|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1434558|NCT00976820|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|Titers are presented as geometric mean titers (GMTs) and measured in titers.|At Day 0 (PRE) and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1434559|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 182|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434560|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - Second Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434561|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - First Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434585|NCT00976716|Secondary|Summary of Adverse Events|The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.|8 days|The safety analysis set consisted of all patients who had taken at least one study medication.|||Participants|||Number
1434562|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - Second Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434563|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - First Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434564|NCT00976820|Secondary|Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis|A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.|At Day 0 (PRE) and at Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434565|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
1434566|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
1434567|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
1434568|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Fold change||95% Confidence Interval|Geometric Mean
1434569|NCT00976820|Primary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.|At Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
1434570|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434571|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain – Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434572|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434573|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain – First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434586|NCT00976716|Secondary|Withdrawal Due to Lack of Efficacy|The number of subjects who withdrew due to insufficient clinical response was evaluated.|8 days|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.|||Participants|||Number
1434574|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434575|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434576|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434577|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434578|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 21|The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434579|NCT00976820|Primary|Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain – Preliminary Analysis|A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.|At Day 0|The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434580|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434581|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434582|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – Second Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434583|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain – First Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 21|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.|||Participants|||Count of Participants
1434584|NCT00976820|Primary|Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.|At Day 21|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.|||Participants|||Count of Participants
1434761|NCT00976339|Secondary|Change in Mammographic Breast Density||1 year|Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.||||||
1434587|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose|The investigator assessed the localized warmth, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||Participants|||Number
1434588|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose|The investigator assessed the redness, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||Participants|||Number
1434589|NCT00976716|Secondary|Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose|The investigator assessed the swelling, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.|Baseline, Days 4 (Visit 2) and 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||Participants|||Number
1434590|NCT00976716|Secondary|Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.|Two, 4 and 6 hours post first dose|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.|||mm||95% Confidence Interval|Mean
1434591|NCT00976716|Secondary|Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose|The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose|6 hours|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID.|||mm||95% Confidence Interval|Mean
1434592|NCT00976716|Secondary|PID in Pain on Active Movement Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
1434593|NCT00976716|Secondary|Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose|The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.|Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
1434594|NCT00976716|Secondary|PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose|The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
1434595|NCT00976716|Secondary|Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose|The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.|Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.|||mm||Standard Deviation|Mean
1434596|NCT00976716|Secondary|Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated “Excellent” and “Good”)|"The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”~Efficacy was based on the patient impression of the study medication (excellent and good) from the first study medication until each time point."|6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)|The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.|||Participants|||Number
1434635|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434597|NCT00976716|Primary|Patient Impressions at Final Visit (the Number of Participants Who Have Rated “Excellent” and “Good”)|"The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”~Efficacy was based on the patient impression of the study medication (“excellent” and “good”) from the first study medication until Final Visit."|8 days|The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.|||Participants|||Number
1434598|NCT00976703|Other Pre-specified|Maternal Morbidities|post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT|30 days after delivery||||diagnoses|||Number
1434599|NCT00976703|Secondary|Time to Foley Expulsion|time from Foley placement until it is spontaneously expulsed from the cervix|an average of 2 hours, up to 12 hours||||hours||Full Range|Median
1434600|NCT00976703|Secondary|Patient Pain/Comfort Rating|Using a visual analog pain scale, with 0 being no pain and 10 being the most severe pain possible, the patients were asked to assess their pain every hour. The highest pain score recorded while the Foley catheter was in place was used. The data are reported as the median and range.|an average of 20 hours, up to 40 hours|All patients had pain scores recorded and used in analysis. The values in the table represented the recorded data available and used in the analysis.|||units on a scale||Full Range|Median
1434601|NCT00976703|Primary|Time to Delivery||an average of 20 hours, up to 40 hours|In order to find a 20% difference with a 40% standard deviation, power of 90%, and alpha of 0.05, we estimated we needed 86 patients in each arm. We aimed to recruit 194 patients to account for potential dropouts and missing data.|||hours||Standard Deviation|Mean
1434602|NCT00976677|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years|All eligible and treated patients are included in this analysis.|||Months||95% Confidence Interval|Median
1434603|NCT00976664|Primary|Oswestry Disability Index (ODI)|This index measures the functional disability of the subject, points on this index can range from 0-50. A higher numeric value on this scale indicates a worse outcome or increased disability (e.g. 0-10: minimal disability; 11-20: moderate disability; 21-30: severe disability; 31-50: crippling). Absolute scores are reported in the data table.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.|||units on a scale||Standard Deviation|Mean
1434604|NCT00976664|Primary|Visual Analog Scale (VAS)|This scale measures pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A higher score on this scale indicates a worse outcome or increase in pain.|Randomization, Week 6, and Week 12|Three participants were lost to follow-up in the Orthotic group and one was lost to follow-up in the Wait group, resulting in a drop from 25 participants in each group to 22 and 24 respectively.|||units on a scale||Standard Deviation|Mean
1434605|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
1434606|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR [mm/hour] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
1434607|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity, > 3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
1434608|NCT00976599|Secondary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
1436792|NCT00959647|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event||Baseline until 30 days following the last administration of study treatment|Safety population: All participants who had received at least 1 dose of study medication.|||Percentage of participants|||Number
1434609|NCT00976599|Secondary|Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Day 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
1434610|NCT00976599|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6 implied remission.|Day -7, 1 (Baseline), 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||units on a scale||Standard Deviation|Mean
1434611|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in TJC; >= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
1434612|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in TJC; >= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
1434613|NCT00976599|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 28, 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||percentage of participants|||Number
1434614|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
1434615|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
1434616|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mmol Cr||Standard Deviation|Mean
1434617|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
1434618|NCT00976599|Primary|Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1|Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as nanogram per millimoles of creatinine (ng/mmol Cr).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mmol Cr||Standard Deviation|Mean
1434619|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434620|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434621|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||pg/mL||Standard Deviation|Mean
1436793|NCT00959647|Secondary|Incidence of Adverse Events Leading to GDC-0449 Discontinuation||30 days following the last administration of study treatment|||||||
1434622|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||pg/mL||Standard Deviation|Mean
1434623|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434624|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434625|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434626|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434627|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434628|NCT00976599|Primary|Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1|Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434629|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1434630|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434631|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||ng/mL||Standard Deviation|Mean
1434632|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434633|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434634|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1434653|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434636|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434637|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1|Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434638|NCT00976599|Primary|Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1|Serum samples were analyzed for SAA concentrations using meso scale discovery (MSD) single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific Electro ChemiLuminescent ImmunoAssay (ECLIA).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.|||ng/mL||Standard Deviation|Mean
1434639|NCT00976599|Primary|Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of IL-34 and IL-18 were not performed as a valid assay was not available.||||||
1434640|NCT00976599|Primary|Plasma Level of Matrix Metallopeptidase (MMP13)||Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28|Analyses of MMP13 was not performed as valid assay for MMP13 was not available.||||||
1434641|NCT00976599|Primary|Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
1434642|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
1434643|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
1434644|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
1434645|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
1434646|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 28|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
1434647|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 10|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pmol/L||Standard Deviation|Mean
1434648|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||picomole per liter (pmol/L)||Standard Deviation|Mean
1434649|NCT00976599|Primary|Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pmol/L||Standard Deviation|Mean
1434650|NCT00976599|Primary|Osteoprotegerin (OPG) Level at Pre-dose on Day 1|Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||picomole per liter (pmol/L)||Standard Deviation|Mean
1434651|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434652|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434654|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434655|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434656|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 28|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434657|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 10|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434658|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434659|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434660|NCT00976599|Primary|Parathyroid Hormone (PTH) Level at Pre-dose on Day 1|Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434661|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1434662|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434663|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434664|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1434665|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1434666|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1434667|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1436794|NCT00959647|Secondary|Incidence and Severity of All Adverse Events and Serious Adverse Events||30 days following the last administration of study treatment|||||||
1434668|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1434669|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||ng/mL||Standard Deviation|Mean
1434670|NCT00976599|Primary|Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1|Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific Enzyme-Linked Immunosorbent Assay [ELISA] method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1434671|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434672|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434673|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434674|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434675|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434676|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434677|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434678|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|4 Hours Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434679|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1|Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.|1 Hour Post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1434680|NCT00976599|Primary|Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1|Blood samples were collected for fluorescence-activated cell sorting [FACS] analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, Bone-marrow cells (B cells) and natural killer (NK) cells were analyzed using fluorescent-labeled antibodies against clusters of differentiation (CD) markers.|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
1434681|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 35 or Early Termination|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 35 or Early Termination|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434682|NCT00976599|Primary|Blood Cytokine Level at 24 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|24 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434683|NCT00976599|Primary|Blood Cytokine Level at 8 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|8 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434684|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 Hours Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434685|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 Hour Post-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434686|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 28|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 28|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434687|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 10|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|Pre-dose on Day 10|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434688|NCT00976599|Primary|Blood Cytokine Level at 4 Hours Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|4 hours post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||pg/mL||Standard Deviation|Mean
1434689|NCT00976599|Primary|Blood Cytokine Level at 1 Hour Post-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.|1 hour post-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434690|NCT00976599|Primary|Blood Cytokine Level at Pre-dose on Day 1|Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, active 70 kDa (p70) form of IL-12(IL-12p70), interferon gamma (IFNgamma) - induced protein 10 (IP-10), TNFalpha, granulocyte macrophage colony-stimulating factor (GM-CSF), macrophage inflammatory protein 1 alpha (MIP1a), monocyte chemotactic protein 1 (MCP1), soluble vascular endothelial growth factor (sVEGF), soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), granulocyte colony-stimulating factor (G-CSF) was measured by immunoassay and the levels were expresses as picogram per milliliter (pg/mL).|Pre-dose on Day 1|FAS included all randomized participants who received at least 1 dose of the study medication.|||pg/mL||Standard Deviation|Mean
1434691|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3E, STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||REU||Standard Deviation|Mean
1434692|NCT00976599|Primary|Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)|Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3 epsilon (CD3E), STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.|Baseline (Day -7)|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||REU||Standard Deviation|Mean
1434693|NCT00976599|Primary|Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28|The intensity of CD3 and CD68 cell infiltration was expressed as the percentage area of the tissue section occupied by positively stained cells. Surface marker CD68 macrophages and CD3 thymus cells (T cells) in the inflammatory cells of synovial tissue were detected by immunohistochemical staining.|Baseline (Day -7), Day 28|FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||percentage area stained||Standard Deviation|Mean
1434694|NCT00976599|Primary|Change From Baseline in Protein Expression of Tumor Necrosis Factor Alpha (TNFalpha), Interleukin-6 (IL-6), Interleukin-17a (IL-17a) and Interleukin-10 (IL-10) at Day 28|Synovial tissue biopsy was to be performed and assayed for protein expression by quantitative PCR using standard curve method. Standard curve was to be generated by linear regression using log threshold cycle versus log (cell number). TNFalpha, IL-6, IL-17 and IL-10 data were to be presented as control normalized expression (relative expression) within synovial tissue.|Baseline (Day -7), Day 28|Analyses of TNFalpha, IL-6, IL-17 and IL-10 were not performed due to insufficient samples and lack of appropriate method to process/analyze the samples.||||||
1434695|NCT00976599|Primary|Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28|Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.|Day -7 (Baseline), Day 28|Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study medication. Analyses of tumor necrosis factor alpha(TNFα), receptor activator of nuclear factor kappa-B ligand(RANKL), osteoprotegerin(OPG) were not performed due to insufficient samples and lack of appropriate method to process/analyze samples.|||relative expression unit (REU)||Standard Deviation|Mean
1434696|NCT00976573|Secondary|Overall Survival Time|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival times will be estimated using the method of Kaplan-Meier.|up to 5 years|Intent-to-treat analysis population: All participants enrolled are included.|||months||95% Confidence Interval|Median
1434697|NCT00976573|Secondary|Confirmed Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Confirmed Tumor Response: A confirmed tumor response is defined to be a CR or PR (by the RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The proportion of tumor responses will be estimated by the number of confirmed tumor responses divided by the total number of evaluable patients. A ninety percent confidence interval for the true proportion of confirmed tumor responses will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution.|Up to 5 years|Intent-to-treat analysis population: All participants enrolled are included.|||percentage of patients||95% Confidence Interval|Number
1434698|NCT00976573|Secondary|Toxicity|For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The percentage of participants reporting a grade 3 or higher toxicity is reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.|Up to 5 years|Participants who completed the study (specified in the Participant Flow) are included.|||percentage of participants|||Number
1434699|NCT00976573|Primary|Progression-free Survival|The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of disease progression or death without documentation of progression. The distribution of PFS times will be estimated using the Kaplan-Meier method. Progression is defined using the RECIST Criteria as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum of diameters recorded on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm of target lesions, or the appearance of one or more new lesions, unequivocal progression of existing non-target lesions, although unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.|Time from randomization to documentation of disease progression or death without documentation of progression;Up to 5 years|Intent-to-treat analysis population: All participants enrolled are included in the primary analysis.|||months||95% Confidence Interval|Median
1434749|NCT00976391|Secondary|Change From Baseline in Body Weight at Weeks 36, 48 and 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed (represented by n=X, X in the category title).|||Kilograms||Standard Deviation|Mean
1434700|NCT00976560|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) up to 6 Weeks|CGI-S assesses the severity of the participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). The number of participants with a CGI-I score of either 1 (“very much improved”) or 2 (much improved”) were grouped together for each timepoint. Participants with no missing CGI-S scores were categorised as having a CGI-S score of ≤ 2 or > 2. The total score was calculated for each participant at each timepoint and percentage was calculated.|Upto Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1434701|NCT00976560|Secondary|"Percentage of Participants With a Clinicians Global Impression of Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 3, 4, 5 and 6."|The number of participantts with a CGI-I score of either 1 (“very much improved”) or 2 (much improved”) were grouped together for each timepoint. Participants with no missing CGI-I scores were categorised as having a CGI-I score of ≤ 2 or > 2.|Weeks 1, 2, 3, 4, 5 and 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1434702|NCT00976560|Secondary|Percentage of Bech Remitters (Participants Whose Total Score Was ≤ 4 at Week 6/Study Exit).|The Bech scale was extracted from the HAMD-17 and comprised of 6 items out of which 5 were 5 point questions and 1 was 3 point question. The Bech Total Score was calculated by summing the individual response scores. Due to the small number of items, missing data was not imputed for the Bech Total Score. If any of the 6 items were missing, the total score was not calculated at that visit. The change from randomization was analysed using suitable BMMRM assuming missing at random MAR. The BECH total score was calculated for each subject at each timepoint and those perticipants with no missing value for BECH total score were categorised as having a BECH total score of ≤ 4 or > 4.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1434703|NCT00976560|Secondary|Percentage of Bech Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).|The Bech scale was extracted from the HAMD-17 and comprised of 6 items out of which 5 were 5 point questions and 1 was 3 point question. The Bech Total Score was calculated by summing the individual response scores. Due to the small number of items, missing data was not imputed for the Bech Total Score. If any of the 6 items were missing, the total score was not calculated at that visit. A responder is a participant who has a ≥50% reduction from randomisation in the total score for that given endpoint. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%. The change from randomization was analysed using suitable BMMRM assuming missing at random.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1434704|NCT00976560|Secondary|Percentage of QIDS-SR16 Remitters (Subjects Whose Total Score Was ≤ 5 at Week 6/Study Exit).|QIDS-SR assesses symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It contains 16 separate items (corresponding to 16 items of the much longer IDS-SR), defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The QIDS-SR total score was calculated by summing over the domain scores. The highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. The QIDS total score was calculated for each subject at each timepoint and those subjects with no missing value for QIDS total score was categorised as having a QIDS total score of ≤ 5 or > 5. Participants whose total score was ≤ 5 were included here.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1434705|NCT00976560|Secondary|Percentage of QIDS-SR16 Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).|QIDS-SR assesses symptoms severity of DSM-IV diagnostic criterion for major depressive disorder. It contains 16 separate items (corresponding to 16 items of the much longer IDS-SR), defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain.The highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. A responder is a participant who has a ≥50% reduction from randomisation in the total score for that given endpoint. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of Participants|||Number
1434706|NCT00976560|Secondary|Percentage of IDS-SR Remitters (Participants Whose Total Score Was ≤ 15 at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. IDS-SR total score was calculated for each participant at each timepoint and those participants with non-missing values for IDS-SR total scores were categorised as having an IDS-C for the respective endpoint of ≤ 15 or > 15. Participants whose total score was ≤ 15 were included here.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1434722|NCT00976521|Secondary|Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration|The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.|30 Days|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total myocardial mass were available for 192 and 190 patients randomized to thrombus aspiration versus no no thrombus aspiration, respectively for the ITT (intention to treat) analysis set.|||Percentage of Total Myocardial Mass||Inter-Quartile Range|Median
1434707|NCT00976560|Secondary|Percentage of IDS-SR Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. A responder is a participant who has a ≥50% reduction from randomisation in the total score for IDS-SR. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%. The change from randomization was analysed using suitable BMMRM assuming missing at random.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
1434708|NCT00976560|Secondary|Percentage of IDS-C Remitters (Participants Whose Total Score Was ≤ 15 at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. IDS-C total score was calculated for each participant at each timepoint and those participants with non-missing values for IDS-C total scores were categorised as having an IDS-C for the respective endpoint of ≤ 15 or > 15. Participants whose total score was ≤ 15 were included here.|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
1434709|NCT00976560|Secondary|Percentage of IDS-C Responders (Participants With a Reduction in Total Score of ≥50% From Randomization at Week 6/Study Exit).|The 30 item IDS is available in two versions IDS-C and IDS-SR. To calculate the total score of IDS, 28 out of the 30 items were scored. Either item 11 or 12 (and 13 or 14) were scored. If 11 and 12 (or 13 and 14) both are scored then the item with the highest score was considered. The total score of the 28 items ranged between 0-84. A responder is a participant who has a ≥50% reduction from randomisation in the total score for IDS-C. The total score was calculated for each participant at each timepoint and the percentage change from randomisation was then calculated as ([Total score at post randomisation visit - Total score at randomisation visit]/ Total score at randomisation visit) * 100%. Responders were those with values of ≤ -50%. The change from randomization was analysed using suitable Bayesian mixed-effects model repeated measures (BMMRM) assuming missing at random (MAR).|Week 6|ITT Only those participants with data available at the indicated time points were analyzed.|||Percentage of Participants|||Number
1434710|NCT00976560|Secondary|Mean Quick Inventory of Depressive Symptomatology Self Report-16 Item (QIDS-SR16) Total Score Derived From the IDS-SR (Only at Weeks 0, 2, 4 and 6)|QIDS-SR assesses symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It contains 16 separate items (corresponding to 16 items of the much longer IDS-SR), defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The QIDS-SR total score was calculated by summing over the domain scores. The highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score.|Weeks 0, 2, 4 and 6|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
1434711|NCT00976560|Secondary|Mean IDS-SR Total Score|The 30 item IDS is available in two versions IDS-SR and IDS-C. To calculate the total score of IDS, 28 out of the 30 items were scored. Either weight loss or weight gain, appetite loss or appetite gain is scored because only one member of each pair is applicable to any given respondent. The standard total score is obtained by summing the ratings of 28 of the 30 items. Each of the 28 items is scored on a 0 to 3 scale (0 – the absence of pathology; 3 – severe pathology). The total scores range from 0 to 84. If more than one response was missing then the score was calculated using the formula Observed Total Score*[1+(Sum of the Maximum Score of the missing values/Sum of the Maximum Score of the non -missing values)].|Up to Week 6|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
1434712|NCT00976560|Secondary|Mean Inventory of Depressive Symptomatology Clinician (IDS-C) Total Score|The 30 item IDS is available in two versions IDS-C and Inventory of Depressive Symptomatology self-rated (IDS-SR). To calculate the total score of IDS, 28 out of the 30 items were scored. Either weight loss or weight gain, appetite loss or appetite gain is scored because only one member of each pair is applicable to any given respondent. The standard total score is obtained by summing the ratings of 28 of the 30 items. Each of the 28 items is scored on a 0 to 3 scale (0 – the absence of pathology; 3 – severe pathology). The total scores range from 0 to 84. If more than one response was missing then the score was calculated using the formula Observed Total Score*[1+(Sum of the Maximum Score of the missing values/Sum of the Maximum Score of the non -missing values)].|Up to Follow-up visit (Day 53)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
1434713|NCT00976560|Secondary|Mean HAMD-17 Total Score|HAMD-17 is Hamilton Depression Rating Scale which has 17 questions. The HAMD-17 Total Score was calculated by summing the individual response scores over the 17 individual components of the interview. The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. If not more than 1 response was missing, the total score was caculated as Observed Total Score * [1 + (Sum of the Maximum Score of the missing values/Sum of the Maximum Score of the non -missing values)]. There were 9 five point questions and 8 three point questions. The responses to the individual questions can have values of 0-2 (three points response) or 0-4 (five points response).|Up to Follow-up visit (Day 53)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Deviation|Mean
1434759|NCT00976352|Secondary|Maximal Inspiratory Pressure|Median (range) Maximal Inspiratory Pressure (MIP), in cm H2O|Baseline and 365 post study agent administration||||cm H2O||Full Range|Median
1434760|NCT00976352|Primary|Safety Assessments of the rAAV1-CMV-GAA (Study Agent), Changes Post Study Agent Administration.|Change in Adeno-associated virus (AAV) antibody level; Change in Alglucosidase alpha (GAA) Antibody level|Change from baseline to 365 post study agent administration.||||mU/mL||Standard Deviation|Mean
1434714|NCT00976560|Secondary|Change From Randomisation Bech Total Score: Bech Score|HAMD-17 has 17 questions. The BECH scale was extracted from the HAMD-17 and comprises of 6 items out of which 5 are 5 point questions and 1 is 3 point question. The Bech scale was extracted from the HAMD-17 and comprised of 6 items out of which 5 were 5 point questions and 1 was 3 point question. The Bech Total Score was calculated by summing the individual response scores and ranged from 0 to 22, with higher scores indicating more severe depression. Due to the small number of items, missing data was not imputed for the Bech Total Score. If any of the 6 items were missing, the total score was not calculated at that visit. The change from randomization was analysed using suitable Bayesian Mixed-Effects Models for Repeated Measures (BMMRM) assuming missing at random MAR.|Up to Follow-up visit (Day 53)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on scale||Standard Deviation|Mean
1434715|NCT00976560|Secondary|Changes From Randomization (Week 0)in IL-6 and TNF-alpha Associated With GW856553 Versus Placebo at Week 1 and Week 6 in the Morning Plasma Levels|Interlukin-6 (IL-6) and Tumor Necrosis Factor-Alpha (TNF-alpha) from the participants with Major Depressive Disorder (MDD) were evaluated and analyzed using suitable mixed-effects model repeated measures (MMRM). Exploratory analysis on plasma levels of IL-6 and TNF-alpha were performed. Week 0 values were considered as Baseline.The change from Baseline was calculated by subtracting the baseline values from the individual post-randomisation values.|Upto Week 6|"Intent-to-Treat (ITT) Population - It consists of all randomised subjects who receive at least one dose of study medication and had at least one post-dose efficacy assessment.~Only those participants with data available at the indicated time points were analyzed."|||picogram/mililitre (pg/mL)||Standard Deviation|Mean
1434716|NCT00976560|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|ECG was obtained at Week 2 and Week 6. ECG was recorded using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and Corrected QT (QTc) intervals (Bazett’s correction was applied to QTc measurements). Number of participants with abnormal ECG readings are summarized.|Up to follow-up Visit (Day 53)|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1434717|NCT00976560|Secondary|Number of Participants With Abnormal Vital Signs (Blood Pressure, Heart Rate)|Vital signs including systolic and diastolic blood pressure and heart rate were taken from day 1 upto follow-up visit. Number of participants with abnormal systolic blood pressure, diastolic blood pressure and heart rate values were summarized.|Up to follow-up Visit (Day 53)|All Subjects Population. Only those participants with data available at the indicated time points were analyzed|||Participants|||Count of Participants
1434718|NCT00976560|Secondary|Number of Participants With Abnormal Haematology and Clinical Chemistry Values|Samples for haematology and clinical chemistry were collected on Weeks 1, 5 and 6. The analyzed haematological parameters were platelet count, red blood cells count, white blood cells count, reticulocyte count, hemoglobin and hematocrit. The analyzed clinical chemistry parameters were urea, creatinine, glucose (fasting), sodium, lactate dehydrogenase (LDH), potassium, chloride, calcium, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, creatine kinase (CK), total and direct bilirubin, albumin, total protein and total cholesterol. Number of participants with any abnormal haematological or clinical chemistry parametrs are summarized here.|Upto Week 6|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1434719|NCT00976560|Secondary|Number of Participants With Suicidality as Assessed by the Columbia Suicidality Severity Rating Scale Score|Suicidility was defined as participants with major depressive disorder who experienced worsening of their depression and/or the emergence of suicidal ideation and behavior. Number of partcipants who experienced suicidality were reported. On the Suicidal Ideation scale of the Columbia Suicide-Severity Rating Scale (C-SSRS) participants were scored as “non-suicidal” (00), “wish to be dead” (01), “non-specific active suicidal thoughts” (02), “active suicidal ideation with associated thoughts of methods without intent” (03), “active suicidal ideation with some intent to act on suicidal thoughts without clear plan” (04) and “active suicidal ideation with plan and intent” (05), based on the most severe score (5 being the most severe).Suicidal ideation of type 4 or 5 in the C-SSRS was categorized as suicidility here.|Upto Week 6|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1434720|NCT00976560|Secondary|Number of Participants With Adverse Events|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. The AEs row include participants with SAEs.|6 Weeks|All Subjects Population - It comprised of all participants who receive at least one dose of study medication.|||Participants|||Count of Participants
1434721|NCT00976560|Primary|Change From Randomization (Week 0) Associated With GW856553 Versus Placebo at Week 6 in the Bech (6-item HAMD-17 [Hamilton Depression Rating Scale]) Score.|HAMD-17 has 17 questions. The HAMD-17 Total Score was calculated by summing the individual response scores over the 17 individual components of the interview. The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. There were 9 five point questions and 8 three point questions. The responses to the individual questions had values of 0-2 (three points response) or 0-4 (five points response). The BECH scale was extracted from the HAMD-17 and comprises of 6 items out of which 5 are 5 point questions and 1 is 3 point question. The Bech Total Score was calculated by summing the individual response scores and ranged from 0 to 22, with higher scores indicating more severe depression. Week 0 values were considered as Baseline.The change from randomization was analysed using suitable Bayesian mixed-effects model repeated measures (BMMRM) assuming missing at random (MAR).|At Week 6|"Intent-to-Treat (ITT) - It comprised of all randomised participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.~Only those participants with data available at the indicated time points were analyzed."|||Scores on scale||Standard Deviation|Mean
1436806|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population|||Days||Standard Deviation|Mean
1434723|NCT00976521|Primary|Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion|The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.|30 Days Post Index Procedure|Evaluable cardiac MRI (cMRI) results at 30 days to assess percentage of total left ventricular mass were available for 181 and 172 patients randomized to intracoronary abciximab infusion versus no abciximab infusion, respectively for the ITT (intention to treat) analysis set.|||Percentage of Left Ventricular Mass||Inter-Quartile Range|Median
1434724|NCT00976508|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)|Response-evaluable set: All participants who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment.|||participants|||Number
1434725|NCT00976508|Secondary|Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab|Percentage of participants with positive total or neutralizing ADA for figitumumab.|Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434726|NCT00976508|Secondary|Mean Change in Glucose Levels Between Fasting and Post Glucose Load|The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.|Screening; Day 8 of Cycle 1; Day 15 of Cycle 2|Glucose tolerance set: All enrolled participants who started treatment and who had at least one baseline or on-study sample submitted. N=number of participants with analyable data for this outcome measure.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1434727|NCT00976508|Secondary|Area Under the Trough Concentrations (AUCtrough)|The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.|Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434728|NCT00976508|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434729|NCT00976508|Secondary|Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.|Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434730|NCT00976508|Secondary|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab|Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.|Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434731|NCT00976508|Secondary|Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434732|NCT00976508|Secondary|Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434733|NCT00976508|Secondary|Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab||Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15|PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.||||||
1434734|NCT00976508|Secondary|Serum Circulating Insulin-like Growth Factor (IGF-1) Levels|The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.|Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)|Biomarker analysis set: all enrolled participants who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1434735|NCT00976508|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.|From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. N=number of participants remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications.|||participants|||Number
1434736|NCT00976508|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From Screening to the follow-up visit (90 days after last dose of figitimumab)|Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications.|||Participants|||Number
1434737|NCT00976495|Secondary|Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)|||mmHg||Standard Error|Mean
1434738|NCT00976495|Secondary|Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)|||mmHg||Standard Error|Mean
1434739|NCT00976495|Secondary|Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)|||mmHg||Standard Error|Mean
1434740|NCT00976495|Primary|Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF)|||% Change of Baseline GFR||Standard Error|Mean
1434741|NCT00976482|Primary|Two-year All-cause Mortality||2 years||||percentage of participants||95% Confidence Interval|Number
1434742|NCT00976456|Secondary|Overall Survival|Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive).|42 months||||months||95% Confidence Interval|Median
1434743|NCT00976456|Primary|Progression Free Survival|Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study).|42 months||||months||95% Confidence Interval|Median
1434744|NCT00976404|Secondary|Serious Adverse Events Attributed to Study Treatments|Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine)|56 weeks||||serious adverse events|||Number
1434745|NCT00976404|Secondary|HIV Specific T-cell Response to Env|HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting)|36 weeks||||response per 10^6 PBMCs||Standard Deviation|Median
1434746|NCT00976404|Secondary|Change From Baseline in CD4+ T Cell Count at Week 56||Week 56||||cells per mm^3||Inter-Quartile Range|Median
1434747|NCT00976404|Secondary|Change From Baseline in HIV DNA in Rectal Tissue at Week 56||Week 56||||log^10 copies per 10^6 cells||Inter-Quartile Range|Median
1434748|NCT00976404|Primary|Change From Baseline in HIV DNA in PBMCs at Week 56||56 weeks||||log^10 copies per 10^6 PBMCs||Inter-Quartile Range|Median
1434800|NCT00975650|Primary|Serum Testosterone Cavg||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
1434750|NCT00976391|Secondary|Change From Baseline in Body Weight at Week 26|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current oral antidiabetic therapy.|Baseline and Week 26|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.|||Kilograms||Standard Error|Least Squares Mean
1434751|NCT00976391|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 4 and <Week 8; HbA1c >9.0% and <0.5% decrease from Baseline between >=Week 8 and <Week 12; HbA1c >8.5% and >=4 weeks since uptitration between >=Week 12 and <Week 16; HbA1c >8.0% and >=4 weeks since uptitration; HbA1c >7.5% and >=4 weeks between >Week 26 and >=Week 48 since uptitration. Participants could have been rescued at any time after Week 4. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 52)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
1434752|NCT00976391|Secondary|Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5% and <7.0% at Week 26) were assessed.|Week 26|ITT Population. Only those participants available at the indicated time point were assessed.|||Participants|||Number
1434753|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category title).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1434754|NCT00976391|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + region|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 26.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1434755|NCT00976391|Secondary|Change From Baseline in HbA1c at Weeks 36, 48 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline is defined as the last available assessment on or prior to the first dose of study drug. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 36, 48 and 52|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1434756|NCT00976391|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 26|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 26.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1434757|NCT00976352|Secondary|Evaluation of Tidal Volume Benefit of rAAV1-CMV-GAA Gene Transfer and Respiratory Muscle Strength Training, Compared to Respiratory Muscle Strength Training Alone.|Best effort tidal volume, referenced to body mass, without use of ventilator assistance. Timeframe for respiratory muscle strength training alone was 90 days prior to dosing, timeframe post adminstration of rAAV1-CMV-GAA was 365 days.|Screening, Baseline, and Day 365 post study agent administration||||mL/kg||Full Range|Median
1434758|NCT00976352|Secondary|Evaluation of Ventilatory Performance Benefit of rAAV1-CMV-GAA Gene Transfer and Respiratory Muscle Strength Training (RMST) Compared to RMST Alone.|Median (range) maximal inspiratory pressure, in cm H2O. Timeframe for RMST training was 90 days prior to rAAV1-CMV-GAA gene transfer. Timeframe for following subjects after rAAV1-CMV-GAA gene transfer was 365 days.|Screening, Baseline, and 365 post study agent administration.||||cm H2O||Full Range|Median
1434762|NCT00976339|Primary|Number of Participants That Successfully Completed the 1-year Intervention||1 year|Data for this study (NCT00976339) is combined with the data for another study (NCT00859651); see NCT00859651 for combined results. Investigator is unable to determine the subject data that should be entered for this study alone, since subject data was combined for the purpose of data analysis. Data for this study alone was not analyzed.||||||
1434763|NCT00976274|Secondary|Change in the Pre- and Post-treatment Oxidized Low-densty Lipoprotein(LDL)||baseline and 12 weeks||||uIU/mL||Standard Deviation|Mean
1434764|NCT00976274|Primary|Change in the Pre- and Post-treatment Systolic Blood Pressure||baseline and 12 weeks||||mm Hg||Standard Deviation|Mean
1434765|NCT00976248|Primary|Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM||End of follow-up, an average of 18 months|13 participants were censored due to follow-up ending prior to new therapy initiation.|||Months||Full Range|Median
1434766|NCT00976248|Primary|Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM.|Progression is defined as a 25% increase in serum IgM from the lowest attained response value or progression of clinically significant disease related symptoms.|End of Treatment, an average of 16 months|13 participants were excluded from this analysis due to treatment and follow-up ending prior to progression.|||Months||Full Range|Median
1434767|NCT00976248|Primary|Overall Response Rate of RAD001 in Patients With Previously Untreated WM|"Overall Response = Complete Response + Near Complete Response + Very Good Partial Response + Partial Response + Minor Response Complete Response: resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A near CR (nCR) is defined as fulfilling all CR criteria in the presence of positive immunofixation test for an IgM paraprotein.~Very Good Partial Response: > 90% reduction in serum IgM levels. Partial Response: > 50% reduction in serum IgM levels. Minor Response: 25-49% reduction in serum IgM levels Progressive Disease: greater than 25% increase in serum IgM level occurs from the lowest attained response value or progression of clinically significant disease related symptom(s).~Stable Disease: < 25% change in serum IgM levels, in the absence of new or increasing adenopathy or splenomegaly and/or other progressive signs or symptoms of WM"|End of Treatment, an average of 16 months||||participants|||Number
1434768|NCT00976209|Secondary|Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets|"Convenience was calculated based on total participants that completed the study.~Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:~Secondary Endpoint~Which product, if any, was more convenient?~The possible answers were:~I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)~I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)~or~• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.|||Percentage of participants|||Number
1434769|NCT00976209|Primary|Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion|"Preference was calculated based on total participants that completed the study.~Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints:~Which product, if any, did you prefer for the relief of nasal congestion?~The possible answers were:~I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet)~I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet)~or~• I did not have a preference"|Visit 6 (Period 2, Day 4)|A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.|||Percentage of participants|||Number
1434770|NCT00976183|Secondary|Number of Participants With Progression Free Survival (PFS) up to 24 Months|Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression|2 years or 24 months||||participants|||Number
1434771|NCT00976183|Primary|Objective Response Rate|Clinical response was assessed by clinical, serologic, and radiographic means.|2 years or 24 months|Response Evaluation Criteria In Solid Tumors (RECIST v1.0)|||participants|||Number
1434772|NCT00976027|Other Pre-specified|Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone|Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis|Day 0 before vaccination to Day 180 after vaccination|Adverse events of special interest were assessed in all participants who received study vaccine (Full Analysis Set).|||Participants|||Number
1434773|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)|Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 14 (post-vaccination) up to 12 Months post-vaccination|The occurrence of events associated with CDC defined ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).|||Participants|||Number
1434774|NCT00976027|Other Pre-specified|Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)|Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).|Day 0 (pre-vaccination) up to the end of the influenza season|The occurrence of events associated with ILI was assessed in all participants who met all study inclusion and exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per-Protocol Analysis Set).|||Participants|||Number
1434775|NCT00976027|Primary|Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.|The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.|Day 0 (pre-vaccination) up to Year 1 post-vaccination|Efficacy was assessed in all participants who met all study inclusion criteria and none of the exclusion criteria, received the vaccine to which they were randomized, and had no protocol violations that might have interfered with evaluation of primary endpoints (Per Protocol Analysis Set).|||Participants|||Number
1434776|NCT00975975|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.|||days||95% Confidence Interval|Median
1434777|NCT00975975|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment, excluding the patient who entered after the stopping rule was met.|||days||95% Confidence Interval|Median
1434778|NCT00975975|Primary|Grade 3-4 Acute GVHD Rate|The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment|||percentage of participants||95% Confidence Interval|Number
1434779|NCT00975923|Secondary|Access of Tools and Use of Quality Improvement Strategies|Follow-up survey of ICU nurse and quality managers for all participating medical centers from Jan 2008 through April 2008 included questions about the implementation of process interventions: Access and use of clinical guidelines tools, access and use of quality improvement tools, and types of quality improvement implementation strategies.|18 months|per protocol|||Percentage of ICUs|||Number
1434780|NCT00975923|Primary|CLABSI and VAP Rates|Central line associated bloodstream infections(CLABSI) and ventilator associated pneumonias (VAP) using Centers for Disease Control and Prevention definitions as number of events per 1,000 device days, data collection and surveillance methods.|18 Months: 3-month baseline and quarterly post-intervention periods|A cluster randomized trial randomly assigned hospitals to either the Collaborative or Tool Kit groups, stratified by region within the United States and ICU volume. Implementation and analysis was at the level of the ICU. One of the 30 hospital in the Tool Kit Group was sold, leaving 29 hospitals. Analysis was conducted per protocol.|||events/1000 device days||Inter-Quartile Range|Median
1434781|NCT00975806|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the start of study drug therapy to death.|Day 1 of study drug to death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
1434782|NCT00975806|Secondary|Duration of Response|Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR)|Day 1 of initial response date to progressive disease|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
1434783|NCT00975806|Secondary|Progression Free Survival (PFS)|Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first.|Day 1 of study drug to disease progression or death|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including MTD, were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
1434784|NCT00975806|Secondary|Phase 1 : Tumor Response Rate According to RECIST 1.1|"Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria:~Treatment response includes both complete response and partial response~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir"|Every 3 cycles; up to month 25|Intent to Treat Population includes participants who took at least one dose of study drug. Study participants with stable disease also reported.|||participants|||Number
1434796|NCT00975650|Primary|Percentage of Subjects With Cavg Within the Reference Range|The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.|Each period is 7 days|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||Participants|||Count of Participants
1434797|NCT00975650|Primary|Serum Dihydrotestosterone Cavg||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
1436807|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population|||Days||Standard Deviation|Mean
1434785|NCT00975806|Secondary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib|Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death|First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
1434786|NCT00975806|Primary|Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|"Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:~Complete response-disappearance of all lesions~Partial response-30% decrease in the sum of diameters of target lesions from baseline~Stable disease-neither shrinkage nor increase of lesions.~Progressive Disease-20% increase in the sum of diameters of target lesions from nadir."|After at least 3 cycles of treatment|Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study.||||||
1434787|NCT00975806|Primary|Phase 1: Maximum Tolerated Dose (MTD)|"The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were:~• Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:~Grade (GR) 3 or 4 non-hematological toxicity lasting for ≥ 14 days~Febrile neutropenia~Gr 4 neutropenia lasting for ≥ 7 days~Gr 4 thrombocytopenia The occurrence of one of the above drug-related toxicities resulting in a clinical and/or laboratory assessment being done within 7 days following the initial finding to examine the participants for resolution of the toxicity. Lack of resolution of the toxicities was considered a DLT.~If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation."|Within 21 days of first dose of treatment|Safety population includes all participants who received at least one dose of the study drug.|||mg|||Number
1434788|NCT00975780|Secondary|Lower Respiratory Tract Infection Other Than Pneumonia|The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe.|2.5 years||||participants|||Number
1434789|NCT00975780|Primary|Pneumonia|The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe.|2.5 years||||participants|||Number
1434790|NCT00975715|Secondary|Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group|Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse).|56 days|The Analysis set included all participants who received study drug and had data available for analysis.|||participants|||Number
1434791|NCT00975715|Secondary|Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type|Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included.|28 days|Analyzed set includes all participants who received study drug and had both baseline and post baseline data available.|||percentage change in seizure frequency||Standard Deviation|Mean
1434792|NCT00975715|Secondary|Percent of Participants With Response During Double-blind Phase, by Treatment Group|Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase.|screening to 28 days|The Full Analysis set included all participants who received study drug.|||percentage of participants|||Number
1434793|NCT00975715|Secondary|Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group|Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)” = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28.|baseline, 28 days and 56 days|The Full Analysis set included all participants who received study drug.|||seizures per 28 days||Standard Deviation|Mean
1434794|NCT00975715|Primary|Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group|Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: “Percent change in partial onset seizure frequency per 28 days from the screening phase” = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 “Partial onset seizure frequency per 28 days” = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.|screening and 28 days|The Full Analysis set included all participants who received study drug.|||percentage change per 28 days||Standard Deviation|Mean
1434795|NCT00975689|Primary|Oxysterol Levels||Six months|Every patient in the trial received the study drug as well as the placebo.|||ng/mL||Standard Error|Mean
1436808|NCT00959049|Secondary|Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population|||Days||Standard Deviation|Mean
1434801|NCT00975650|Primary|Serum Testosterone Ln-AUCt||0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng.h/dL||Standard Deviation|Mean
1434802|NCT00975650|Primary|Serum Testosterone Ln-Cmax|The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.|0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.|Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.|||ng/dL||Standard Deviation|Mean
1434803|NCT00975637|Secondary|Percent of Body Surface Area (BSA) Affected by Psoriasis|To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change ion percentage of BSA has occurred.|Baseline and Week 12||||percentage of BSA psoriasis||Standard Deviation|Mean
1434804|NCT00975637|Primary|To Establish a Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 and to Identify an Appropriate Dose Regimen for Future Trials|At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score.|Baseline and 12 weeks||||percentage of psoriasis improvement||Standard Deviation|Mean
1434805|NCT00975611|Primary|Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.||week 4 and week 8|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.||||||
1434806|NCT00975585|Secondary|Symptoms of Dryness|Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1434807|NCT00975585|Secondary|Bulbar Redness|The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1434808|NCT00975585|Secondary|Limbal Redness|The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1434809|NCT00975585|Primary|Overall Comfort|After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks and 4 weeks|Analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1434810|NCT00975585|Primary|Overall Comfort|After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|2 weeks|Analysis includes subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1434811|NCT00975585|Primary|Visual Acuity|Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|2 weeks||||logMAR units||Standard Error|Least Squares Mean
1434812|NCT00975585|Primary|Average Corneal Staining|The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.|2 weeks|Analysis included all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1434813|NCT00975507|Secondary|Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL|Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.|||Participants|||Number
1434814|NCT00975507|Secondary|Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL|Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.|||Participants|||Number
1434815|NCT00975507|Secondary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer <1.25 gpELISA units/mL at baseline, and followed protocol procedures.|||Participants|||Number
1434816|NCT00975507|Secondary|Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL|Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.|||Participants|||Number
1434817|NCT00975507|Primary|Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline|Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline|6 weeks Postvaccination|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.|||Participants|||Number
1434818|NCT00975481|Primary|Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)|ARCI (BG) is measure of other subjective effects. It is a set of 13 questions in which each question contributes to total score. Participants select ‘False’ / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects. Emax: largest effect score between 0 - 24 hours post-dose. Emin: smallest effect score between 0 - 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on Scale||Standard Deviation|Mean
1434819|NCT00975481|Primary|Other Subjective Effects- Drug Similarity|Drug similarity VAS is one of the measures of other subjective effects. It assesses the similarity of the drug recently received by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= not at all similar) to 'extremely' (score of 100 mm= very similar). Recently received drugs were compared with placebo, benzodiazepines, codeine/morphine, Tetrahydrocannabinol (THC), pseudoephedrine.|12 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period. 'n' is signifying those participants who were evaluated for this measure for various drugs for similarity in each treatment group.|||mm||Standard Deviation|Mean
1434820|NCT00975481|Primary|Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])|Any drug effects VAS is one of the measures of other subjective effects. It assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is the largest effect score between 0.5 to 24 hours post-dose.|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434821|NCT00975481|Primary|Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)|"Alertness/Drowsiness VAS is one of the measures of sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither drowsy nor alert (score of 50 mm), on the left with very drowsy (score of 0 mm) and on the right with very alert (score of 100 mm). Emin is the smallest effect score between 0 to 24 hours post-dose."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434822|NCT00975481|Primary|Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)|ARCI (PCAG) is one of the measures of sedative effects. It is a set of 15 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when answer is opposite to scoring direction. Score range: 0 to 15, higher score indicated higher sedative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on Scale||Standard Deviation|Mean
1434823|NCT00975481|Primary|Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)|ARCI (LSD) is one of the measures of negative effects. It is a set of 14 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to scoring direction. Score range: 0 to 14, higher score indicated higher negative effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on Scale||Standard Deviation|Mean
1434824|NCT00975481|Primary|Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])|"Bad effects VAS is one of the measures of negative effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is largest effect score between 0.5 to 24 hrs."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434834|NCT00975416|Primary|Therapeutic Alliance|"Penn Helping Alliance Questionnaire containing 19 questions with possible scores from 19(low therapeutic alliance)-114(high therapeutic alliance).~Working Alliance Inventory containing 36 questions with possible scores from 36(low therapeutic alliance)-252 (high therapeutic alliance)."|Post 12 weeks treatment with cognitive behavioral therapy|Number of participants for analysis was determined by the number of participants who had post-treatment outcome measures.|||units on a scale||Standard Deviation|Mean
1434825|NCT00975481|Primary|Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])|"High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is largest effect score between 0 to 24 hours."|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434826|NCT00975481|Primary|Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])|"Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).~Emax is the largest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434827|NCT00975481|Primary|Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)|ARCI (MBG) is one of the measures of positive effects. It is a set of 16 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to the scoring direction. Score range: 0 to 16, higher score indicated positive effects. Emax: largest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Units on scale||Standard Deviation|Mean
1434828|NCT00975481|Primary|Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)|SDV is one of measures of balance of effects. It is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between drug administered and different monetary values. Participants were asked to choose between receiving another dose of same drug or an envelope containing specified amount of money, but they did not receive drug or money as described. Possible score range from 0.25 to 50. Higher score range indicates higher SDV. Emax: largest effect score between 6-24 hours post-dose.|6, 12, 24 hrs post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||Dollar||Standard Deviation|Mean
1434829|NCT00975481|Primary|Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Good and Bad effects VAS is one of the measures of balance of effects that assesses the effect experienced by the participant on a 100 mm bipolar VAS, anchored in the center with a neutral anchor of neither good nor bad effects (score of 50 mm), on the left with bad effects(score of 0 mm) and on the right with good effects (score of 100 mm).~Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434830|NCT00975481|Primary|Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])|"Take drug again VAS is one of the measures of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely not, 50 mm = do not care, and 100 mm = definitely so).~Emax is largest effect score between 6 hours to 24 hours."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434831|NCT00975481|Primary|Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Overall drug liking VAS is one of the measures of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm= neither like nor dislike, and 100 mm= strong liking).~Emax is the largest effect score between 6 to 24 hours post-dose. Emin is the smallest effect score between 6 to 24 hours post-dose."|6, 12, 24 hours post-dose|The pharmacodynamic analysis included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434832|NCT00975481|Primary|Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|"Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm).~Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose."|0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose|The pharmacodynamic analysis population included all randomized participants in the treatment phase who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter in at least 1 treatment period.|||mm||Standard Deviation|Mean
1434833|NCT00975416|Other Pre-specified|Drug Craving|Cocaine Craving Questionnaire|Post-treatment|||||||
1434865|NCT00975195|Secondary|Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)|Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set|||meters||Standard Error|Least Squares Mean
1434835|NCT00975286|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1434836|NCT00975286|Secondary|Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. DTSQ: 8-item questionnaire to assess treatment satisfaction and patient perception of hyper and hypoglycemia. Each question (Q) scored on a Likert scale from 0 to 6. Six items (Q1 and 4-8; higher score = more satisfaction) measured treatment satisfaction and were summed to calculate treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied). Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively and lower scores represented good perceived blood glucose control. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline DTSQ assessment during on-treatment period. Missing data was imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
1434837|NCT00975286|Secondary|Percentage of Patients Requiring Rescue Therapy During the Double-blind Period|Routine fasting SMPG, central laboratory FPG and HbA1c values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG and HbA1c were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >200 milligram/deciliter (mg/dL) (11.1 mmol/L) or HbA1c >9%, from Week 8 to Week 24: fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1434838|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1434839|NCT00975286|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1434840|NCT00975286|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1434841|NCT00975286|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period. Missing data was imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
1434842|NCT00975286|Secondary|Change From Baseline in Average Insulin Glargine Daily Dose at Week 24|Change was calculated by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline insulin glargine dose assessment during on-treatment period. Missing data was imputed using LOCF.|||units per day||Standard Error|Least Squares Mean
1434843|NCT00975286|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period. Missing data was imputed using LOCF.|||kilogram||Standard Error|Least Squares Mean
1434844|NCT00975286|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period. Missing data was imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
1434845|NCT00975286|Secondary|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period. Missing data was imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
1434846|NCT00975286|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period. Missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
1434847|NCT00975286|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 14 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period. Last observation carried forward used.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1434848|NCT00975221|Secondary|Percent Change From Baseline in Plasma Parathyroid Hormone Level During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).|||percent change||Standard Error|Least Squares Mean
1434849|NCT00975221|Secondary|Percent Change From Baseline in Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set with at least 1 post-baseline measurement; for participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (LVCF imputation).|||percent change||Standard Error|Least Squares Mean
1434850|NCT00975221|Secondary|Percentage of Participants With a ≥ 1 mg/dL (0.25 mmol/L) Decrease From Baseline in Mean Corrected Total Serum Calcium Concentration During the EAP||Baseline and the EAP (mean of Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.|||percentage of participants|||Number
1434851|NCT00975221|Primary|Percentage of Participants With Mean Corrected Total Serum Calcium Concentration ≤ 10.3 mg/dL (2.57 mmol/L) During the EAP||Efficacy assessment phase (study visits at Weeks 16, 20, 24, and 28)|Full analysis set (all participants randomized to treatment). For participants with no data for the EAP, the last post-baseline value from the titration phase was used to impute the missing EAP values (last value carried forward (LVCF) imputation). Participants with only baseline information were counted as non-responders.|||percentage of participants|||Number
1434852|NCT00975195|Secondary|Change in On-treatment Physician Global Evaluation|"Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
1434853|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
1434866|NCT00975195|Secondary|Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)|Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set|||kg/m2||Standard Error|Least Squares Mean
1434854|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
1434855|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
1434856|NCT00975195|Secondary|Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain|"Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 27 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
1434857|NCT00975195|Secondary|Change in On-treatment PEFR as Measured by Home Based Spirometry|Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set|||Litres/sec||Standard Error|Least Squares Mean
1434858|NCT00975195|Secondary|Change in On-treatment FVC as Measured by Home Based Spirometry|Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set|||Litres||Standard Error|Least Squares Mean
1434859|NCT00975195|Secondary|Change in On-treatment FEV1 as Measured by Home Based Spirometry|Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18, 27, 36, 45 and 52 visits|Treated set|||Litres||Standard Error|Least Squares Mean
1434860|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “extremely/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
1434861|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “a lot/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
1434862|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “a lot/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
1434863|NCT00975195|Secondary|Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain|"Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from “not at all/never” to “extremely/always” on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough.~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 12, 18 and 52 visits|Treated set who completed CASA-Q|||units on a scale||Standard Error|Least Squares Mean
1434864|NCT00975195|Secondary|Change in On-treatment BODE Index|Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 18 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
1434867|NCT00975195|Secondary|Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale|"Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health.~Scale from 0 to 4:~0 = not troubled by breathlessness, except during strenuous exercise~1 = short of breath when hurrying or walking up a slight hill~2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace~3 = stops for breath after approximately 100 yards, or after a few minutes on the level~4 = too breathless to leave the house, or breathless when dressing or undressing~No breathlessness was given a score of -1~Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest."|Baseline and week 18 and 52 visits|Treated set|||units on a scale||Standard Error|Least Squares Mean
1434868|NCT00975195|Secondary|Change in On-treatment Lung Function as Measured by Trough FEV1|Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.|Baseline and week 6, 12, 18 and 52 visits|Treated set|||Litres||Standard Error|Least Squares Mean
1434869|NCT00975195|Secondary|Severity of On-treatment COPD Exacerbations|Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
1434870|NCT00975195|Secondary|Proportion of Patients With at Least One On-treatment COPD Exacerbation|Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
1434871|NCT00975195|Secondary|Number of On-treatment COPD Exacerbations|"Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined.~Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set|||exacerbations per patient-year||95% Confidence Interval|Mean
1434872|NCT00975195|Secondary|Time to First On-treatment COPD Exacerbation|"Time to first on-treatment COPD exacerbation of any severity. The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set|||days||95% Confidence Interval|Number
1434873|NCT00975195|Secondary|Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.|Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
1434874|NCT00975195|Secondary|Number of Severe On-treatment COPD Exacerbations|"Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~Measured values show adjusted event rate."|During randomised treatment, up to 488 days|Treated set|||exacerbations per patient-year||95% Confidence Interval|Mean
1434875|NCT00975195|Secondary|Time to First Severe On-treatment COPD Exacerbation|"Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.~The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set|||days||95% Confidence Interval|Number
1434876|NCT00975195|Secondary|Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation|Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.|During randomised treatment, up to 488 days|Treated set|||percentage of participants|||Number
1434877|NCT00975195|Secondary|Number of Moderate or Severe On-treatment COPD Exacerbations|"Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.~Measured values show adjusted mean event rate."|During randomised treatment, up to 488 days|Treated Set|||exacerbations per patient-year||95% Confidence Interval|Mean
1434906|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434878|NCT00975195|Primary|Time to First Moderate or Severe On-treatment COPD Exacerbation|"A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for >6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The measure type displays the 25th percentile and its 95% confidence interval."|During randomised treatment, up to 488 days|Treated set|||days||95% Confidence Interval|Number
1434879|NCT00975156|Secondary|6 Minute Walking Distance (6MWD)||Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention||||meters (m)||Standard Deviation|Mean
1434880|NCT00975156|Primary|10-meter Walking Test (10mWT)||Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention|Analysis was determined per protocol (i.e.between-group variation)|||meters per second (m/s)||Standard Deviation|Mean
1434881|NCT00975143|Primary|Co-Primary Outcome 2: Proportion of Patients Who Achieve at Least a 90% Reduction in Total Number of Nodular Lesions (Facial and Truncal).|"The percentage of patients in each group who achieved ≥90% reduction in the total nodular lesion count from Baseline to Week 20 was calculated along with its 95% CI (normal approximation). A 95% 2-sided CI on the difference between treatments (CIP-ISOTRETINOIN minus Isotretinoin) was also computed.~Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference > -10."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.|||percentage of participants||95% Confidence Interval|Number
1434882|NCT00975143|Secondary|Proportion of Patients Who Are Rated as Clear/Almost Clear on the Six-point Physicians' Global Assessment Scale (PGSA).|PGSA categories: 1 (Almost clear); 2 (Mild); 3 (Moderate); 4 (Severe); 5 (Very severe). A grade of either 0 (clear) or 1 (almost clear) on the 6-point PGSA scale within the Week 20 analysis window was considered a success.|20 weeks|Analysis based on the Per Protocol (PP) Population. Patients with a Baseline PGSA score of 0 or 1 (i.e., who had primarily truncal lesions at Baseline) were excluded from the analysis, as PGSA evaluated facial lesions.|||percentage of participants||95% Confidence Interval|Number
1434883|NCT00975143|Primary|Co-primary Outcome 1: Change From Baseline in Total Nodular Lesion Count (Facial and Truncal)|"The change from Baseline to Week 20 in the total number of nodular lesions was calculated as the Week 20 lesion count minus Baseline lesion count and compared using Analysis of Covariance (ANCOVA), controlling for Baseline total nodular lesion count, gender and analysis site.~The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was also calculated using the ANCOVA model.~Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference < 4."|20 weeks|Analysis based on the Per Protocol (PP) Population, defined as all randomized patients who were at least 75% compliant with their assigned treatment, had no major study protocol violations, had a Week 20 count of total nodular lesions, and did not use any disallowed medications during the 20 study weeks.|||Lesions||Standard Deviation|Mean
1434884|NCT00975130|Secondary|Percentage of Participants Achieving Remission|Remission was defined as achievement of a DAS28-ESR < 2.6.|Start of Month 8, Start of Month 9, Start of Month 10, Start of Month 11, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.|||Percentage of Participants||95% Confidence Interval|Number
1434885|NCT00975130|Secondary|Mean Area Under the DAS28-ESR Curve From Study Month 6 to Month 12|"The DAS28-ESR is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR, and participant assessment of disease activity measure on a visual analogue scale. The DAS28-ESR has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Minimum score=0 (best) to maximum score=10 (worst). The DAS28-ESR area under the curve can be calculated from the DAS28-ESR score versus time curve to provide an assessment of changes in disease activity over time.~The area under the DAS28-ESR score versus time curve was computed using the trapezoidal rule and using raw DAS28-ESR score values at Part-2 Baseline, end of Month 12, and at least 2 intermediate time points. The DAS28-ESR area under the curve was then averaged over the total duration (months) and expressed as units on a scale."|End of Month 6, End of Month 12|8 participants (3 poor quality data, 4 without a post-baseline DAS28-ESR, and 1 did not take Part 2 medication) and 7 participants (5 poor data quality, 1 without a DAS28-ESR at baseline, 1 without post-baseline DAS28-ESR) were excluded from the efficacy evaluable population for the IV-GLM 2mg/kg + SC GLM 50 mg and SC-GLM50 arms, respectively.|||Units on a Scale||Standard Deviation|Mean
1434886|NCT00975130|Secondary|Number of Participants With a Participant Acceptable Symptom State (PASS) at Month 4, Month 6, and Month 8|The number of participants achieving PASS was evaluated at study Month 2, Month 4, and Month 6 was calculated. PASS is participant self-evaluation tool that uses a VAS 0mm (best) - 100mm (worst), with a score <=31 representing an acceptable PASS.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
1434974|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434887|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant indicates their health state by ticking the box against the most appropriate statement. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
1434888|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
1434889|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434890|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Physician Experience Level at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434891|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
1434892|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435089|NCT00974571|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1434893|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Smoking Status at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434894|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434895|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434896|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434897|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434898|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434915|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434899|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the EQ-5D by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434900|NCT00975130|Secondary|Mean Change From Baseline in EQ-5D by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score. DMARD Combination 1=MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2=MTX + leflunomide; Combination 3=MTX +sulfasalazine; Combination 4=MTX + hydrochloroquine, chloroquine, chloroquine phosphate+sulfasalazine; Combination 5=leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434901|NCT00975130|Secondary|Mean Change From Baseline in the EuroQOL (EQ-5D) Quality-of-Life Questionnaire by Concomitant MTX Dose at Month 2, Month 4, and Month 6|Concomitant MTX dose was defined as low < 10mg/wk, medium >= 10 to < 15 mg/week, and and high >=15 mg/week. The EQ-5D assesses the 5 domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant is asked to indicate their health state by ticking the box against the most appropriate statement in each of the 5 dimensions. The digits (1 [best] to 3 [worst]; with 0= no problems, 1 = some problems, 2 = some problems, and 3= severe problems) for the 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1 to 3 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434902|NCT00975130|Secondary|Number of Participants Who Achieved Minimal or Absence of Functional Impairment|The number of participants that achieved minimal or absence of functional impairment as assessed by the HAQ at study Month 2, Month 4, and Month 6 was calculated. Minimal or absence of functional impairment was defined as a HAQ score of <=0.5. The HAQ evaluates participants on a scale of 0 to 3, with 0=with no difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
1434903|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
1434904|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a scores ranging from 0 (best) to 3 (best) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
1434905|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434984|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434907|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
1434908|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434909|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Smoking Status at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434910|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434911|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434912|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434913|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434914|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the HAQ-DI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435213|NCT00972777|Secondary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 3|Microbial Eradication at Visit 3, (LOCF), mITT Population.|||eyes|||Number
1434916|NCT00975130|Secondary|Mean Change From Baseline in HAQ-DI by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst) with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434917|NCT00975130|Secondary|Mean Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline the disability index of the HAQ was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The HAQ-DI assesses 8 categories of daily activity including dressing, arising, eating, walking, hygiene, reach, grip, and common activities with a score 0 (best) to 3 (worst)with 0=able to do, 1=with some difficulty, 2=with much difficulty, and 3=unable to do for a combined total score of 0 (best) to 32 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434918|NCT00975130|Secondary|Number of Participants Achieving Low Disease Activity and Remission at Month 2, Month 4, and Month 6|The number of participants achieving low disease activity or remission was calculated by the DAS28-ESR, DAS28-CRP, and SDAI at study Month 2, Month 4, and Month 6. Low disease activity by DAS28-ESR was defined as >= 2.6 to 3.2, and remission was defined as a DAS28-ESR <2.6. Low disease activity by DAS28-CRP was defined as DAS28-CRP >=2.6 to 3.2, and remission was defined as DAS28-CRP >2.6. Low disease activity by SDAI was defined as SDAI >5.0 to <=20, and remission was defined as SDAI <=5.0.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
1434919|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-CRP EULAR Response|DAS28-CRP EULAR response is defined as a good or moderate response that results in a DAS28-CRP >=0.6.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
1434920|NCT00975130|Secondary|Number of Participants Who Achieved DAS28-ESR EULAR Response|EULAR response was assessed at the end of Month 2, Month 4, and Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response would was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2.|Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Participants|||Number
1434921|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434922|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434923|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435007|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1434924|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Physician Experience Level at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434925|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
1434926|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434927|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Smoking Status at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434928|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434929|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434930|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease with increasing scores indicating increased burden of disease. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435214|NCT00972777|Secondary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 3|Clinical Resolution at Visit 3, (LOCF) mITT Population.|||eyes|||Number
1435215|NCT00972777|Primary|Microbial Eradication|The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.|Visit 2|Microbial Eradication at Visit 2, (LOCF), mITT Population.|||eyes|||Number
1434931|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434932|NCT00975130|Secondary|Mean Change From Baseline in SDAI by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434933|NCT00975130|Secondary|Mean Change From Baseline in SDAI by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0 cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434934|NCT00975130|Secondary|Mean Change From Baseline in SDAI Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count (28-joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10 cm [worst]) and level of C‐reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434935|NCT00975130|Secondary|Mean Change From Baseline in the Simplified Disease Activity Index (SDAI) Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the SDAI was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28‐joint assessment), patient and physician global assessment of disease activity (VAS 0cm [best] – 10cm [worst]) and level of C-reactive protein (mg/dL, normal <1 mg/dL) with increasing scores indicating increased level of disease. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434936|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434937|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
1435216|NCT00972777|Primary|Clinical Resolution|The absence of both conjunctival discharge and bulbar conjunctival injection.|Visit 2|Clinical Resolution at Visit 2, (LOCF), mITT Population.|||eyes|||Number
1434938|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434939|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434940|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
1434941|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434942|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434943|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434944|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435280|NCT00972543|Secondary|Haematology Laboratory Assessments - Eosinophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1434945|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP with increasing scores indicating increased burden of disease. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-CRP > 5.1 = high disease activity, DAS28-CRP < 3.2 to < =5.1 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434946|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434947|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434948|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434949|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts & swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP >5.1 =high disease activity, DAS28-CRP <3.2=low disease activity, and DAS28-CRP <2.6=remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 =leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434950|NCT00975130|Secondary|Mean Change From Baseline in DAS28-CRP Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-CRP measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the CRP. The DAS28-CRP is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-CRP> 5.1 = high disease activity, DAS28-CRP < 3.2 = low disease activity, and DAS28-CRP <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434951|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1436809|NCT00959049|Secondary|Serious Adverse Events (SAEs)||6 months after last study vaccination|Safety Population|||Participants|||Number
1434952|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434953|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434954|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Physician Experience Level at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434955|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
1434956|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434957|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Smoking Status at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434958|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435281|NCT00972543|Secondary|Haematology Laboratory Assessments - Monocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1434959|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. Increasing scores indicate increased burden of disease. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434960|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR with increasing scores indicating increased level of disease burden. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434961|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR >5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434962|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434963|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR <3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434964|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The DAS28-ESR measures disease burden using patient global health (self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX+sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434965|NCT00975130|Secondary|Mean Change From Baseline in DAS28-ESR Score by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the DAS28-ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The DAS28-ESR measures disease burden using patient global health (patient self-assessment), tender joint-counts and swollen joint-counts (up to 28), and the ESR. The DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). Increasing scores indicate increased burden of disease with DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435282|NCT00972543|Secondary|Haematology Laboratory Assessments - Lymphocytes|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1434966|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the baseline physician expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
1434967|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Units on a Scale||Standard Deviation|Mean
1434968|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434969|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434970|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
1434971|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434972|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434973|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR or at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434975|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434976|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434977|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434978|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434979|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the physician global assessment of disease by concomitant DMARD background treatment was evaluated at Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434980|NCT00975130|Secondary|Mean Change From Baseline in the Physician Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in physician global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The physician global assessment of disease activity was evaluated using a VAS (0mm [best] - 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1434981|NCT00975130|Secondary|Mean Change From Baseline in CRP by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434982|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434983|NCT00975130|Secondary|Mean Change From Baseline in CRP by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434985|NCT00975130|Secondary|Mean Change From Baseline in CRP by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||mg/L||Standard Deviation|Mean
1434986|NCT00975130|Secondary|Mean Change From Baseline in CRP by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434987|NCT00975130|Secondary|Mean Change From Baseline in CRP by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434988|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in CRP by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434989|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434990|NCT00975130|Secondary|Mean Change From Baseline in CRP by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR scores of > 3.2 to <=5.1 indicate moderate disease activity and DAS28-ESR scores of > 5.1 indicate high disease activity.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434991|NCT00975130|Secondary|Mean Change From Baseline in CRP by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum CRP by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434992|NCT00975130|Secondary|Mean Change From Baseline in CRP by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434993|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum CRP by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434994|NCT00975130|Secondary|Mean Change From Baseline in CRP by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum CRP by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1434995|NCT00975130|Secondary|Mean Change From Baseline in C-Reactive Protein (CRP) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum CRP was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mg/L||Standard Deviation|Mean
1435008|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in serum ESR by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1434996|NCT00975130|Secondary|Mean Change From Baseline in ESR by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1434997|NCT00975130|Secondary|Mean Change From Baseline in ESR by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1434998|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1434999|NCT00975130|Secondary|Mean Change From Baseline in ESR by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435000|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||mm/h||Standard Deviation|Mean
1435001|NCT00975130|Secondary|Mean Change From Baseline in ESR by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435002|NCT00975130|Secondary|Mean Change From Baseline in ESR by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435003|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in ESR by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435004|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435005|NCT00975130|Secondary|Mean Change From Baseline in ESR by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435006|NCT00975130|Secondary|Mean Change From Baseline in ESR by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant serum ESR by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435009|NCT00975130|Secondary|Mean Change From Baseline in ESR by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in participant serum ESR by concomitant DMARD background treatment was calculated at study Month 2, Month 4, and Month 6. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435010|NCT00975130|Secondary|Mean Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The change from baseline in participant serum ESR was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||mm/h||Standard Deviation|Mean
1435011|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the physician's expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The physician's expectation of treatment outcome was assessed at the start of Month 4, when physicians were asked to rate their expectations of treatment outcome as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435012|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the number of patients treated with biologics by the treating physician was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The number of patients treated with biologics is defined as the number of patients with rheumatoid arthritis treated by the physician in the last month with biologic agents.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435013|NCT00975130|Secondary|mm [Best]Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by physician experience level with biologics was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435014|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the treating physician level of experience was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Physician experience is defined as the number of years the treating physician has experience managing patients with rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435015|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline expectation of treatment outcome was evaluated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Score on a Scale||Standard Deviation|Mean
1435016|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant eligibility for anti-TNF treatment was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1441668|NCT00923260|Primary|Components of Metabolic Syndrome (Total Cholesterol)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
1435017|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Smoking Status at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant baseline smoking status was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435018|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline serum level of anti-CCP was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435019|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline RF Level at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline RF level was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435020|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435021|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by the participant duration of disease was calculated at study Month 2, Month 4, and Month 6. The duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435022|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity Score by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity score by the number of participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435023|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the participant global assessment of disease activity by participant concomitant corticosteroid use was calculated at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435024|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The participant global assessment of disease activity was evaluated using a VAS (0mm [best] – 100mm [worst]) with increasing scores indicating increased level of disease. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435034|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline RF Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of tender joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1450582|NCT00847886|Secondary|Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.|||ng/mL||Standard Deviation|Mean
1435025|NCT00975130|Secondary|Mean Change From Baseline in Participant Global Assessment of Disease Activity by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in participant global assessment of disease activity was calculated by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. The participant global assessment of disease activity was evaluated using a visual analogue scale (VAS; 0mm [best] -100mm [worst]) with increasing scores indicating increased level of disease.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Score on a Scale||Standard Deviation|Mean
1435026|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints. was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435027|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435028|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435029|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435030|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Tender Joints||Standard Deviation|Mean
1435031|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Eligibility for Anti-TNF Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435032|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Smoking History at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435033|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Anti-CCP Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435088|NCT00974571|Secondary|Mean Change From Baseline in Composite Symptoms Score|Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].|Baseline and first 4 weeks in 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.|||Score 0 (best) to 3 (worst)||95% Confidence Interval|Least Squares Mean
1435035|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant baseline level of disease activity, as measured by DAS28, at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435036|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. Duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435037|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by the number of participant DMARD failures at baseline at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435038|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant baseline concomitant steroid treatment at study Month 2, Month 4, and Month 6. A total 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435039|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant DMARD Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant background DMARD treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435040|NCT00975130|Secondary|Mean Change From Baseline in the Number of Tender Joints by Concomitant MTX Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the number of tender joints was calculated by participant concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week) at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Tender Joints||Standard Deviation|Mean
1435041|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the the Physician Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician's expectation of treatment outcome at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The physician's expectation of treatment outcomes was assessed at the start of Month 4 at which time physicians were asked to rate their expectations of treatment outcome in each participant as: high disease activity, moderate disease activity, low disease activity, or remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435042|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of Patients Treated by the Physician With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the baseline number of patients the physician treats with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. The number of patients treated with biologics is defined as the number of patients treated by the physician in the last month with biologics for rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435043|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level With Biologics at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level with biologics at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis with biologics.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435044|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Physician Experience Level at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the physician experience level at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. Physician experience is defined as the number of years the treating physician has experience managing rheumatoid arthritis.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435045|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Participant Baseline Expectation of Treatment Outcome at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by the participant baseline expectation of treatment outcome at study Month 2, Month 4, Month 6. A total of 28 joints were evaluated. The participant expectation scale was evaluated by questionnaire for a categorical score of 1 (best) to 5 (worst).|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline. Participants were grouped by participant expectation score into 3 groups: <=1.5, >1.5 to <1.86, and >=1.86.|||Swollen Joints||Standard Deviation|Mean
1435046|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Eligibility for Anti-Tumor Necrosis Factor (Anti-TNF) Treatment at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant eligibility for anti-TNF treatment at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435047|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Smoking History at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the baseline participant smoking status at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. Pack years smoked is defined as the total number of packs smoked per day multiplied by the number of years the participant smoked.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435048|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Anti-Cyclic Citrullinated Antibody (Anti-CCP) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of anti-CCP at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435049|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Rheumatoid Factor (RF) Level at Month 2, Month 4, and Month 6|The change from baseline in the mean number of swollen joints was calculated by the participant baseline level of RF at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435050|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Baseline Level of Disease Activity at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline level of disease activity was calculated at study Month 2, Month 4, and Month 6 by the participant's level of baseline disease activity, as measured by DAS28-ESR. A total of 28 joints were evaluated. DAS28-ESR > 5.1 = high disease activity, DAS28-ESR < 3.2 to < =5.1 = low disease activity, and DAS28-ESR <2.6 = remission.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435051|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Duration of Disease at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated by the participant duration of disease at study Month 2, Month 4, and Month 6. The participant duration of disease is defined as the time since the diagnosis of rheumatoid arthritis. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435052|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by the Number of DMARD Failures at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints by the number of baseline participant DMARD failures was calculated at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435053|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Corticosteroid Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints by participant baseline concomitant corticosteroid treatment was calculated at study Month 2, Month 4, and Month 6 . A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435054|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Disease Modifying Antirheumatic Drug (DMARD) Background Treatment at Month 2, Month 4, and Month 6|The mean change from baseline in the number of swollen joints was calculated by participant baseline background DMARD treatment regimen at study Month 2, Month 4, and Month 6. A total of 28 joints were evaluated. DMARD Combination 1 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate; Combination 2 = MTX + leflunomide; Combination 3 = MTX + sulfasalazine; Combination 4 = MTX + hydrochloroquine, chloroquine, chloroquine phosphate + sulfasalazine; Combination 5 = leflunomide only.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1450583|NCT00847886|Primary|Amount of 7-OH-MTX Excreted in the Urine||Day 15||||µg||Standard Deviation|Mean
1435055|NCT00975130|Secondary|Mean Change From Baseline in the Number of Swollen Joints by Concomitant Methotrexate (MTX) Dose at Month 2, Month 4, and Month 6|The mean change from baseline in the mean number of swollen joints was calculated at study Month 2, Month 4, and Month 6 by concomitant MTX dose (low < 10mg/wk, medium >= 10 to < 15 mg/week, and high >=15 mg/week). A total of 28 joints were evaluated.|Baseline, Month 2, Month 4, Month 6|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR. n values represent the number of participants at baseline.|||Swollen Joints||Standard Deviation|Mean
1435056|NCT00975130|Primary|Number of Participants Experiencing Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at the Start of Month 11 and End of Month 12|The number of participants experiencing DAS28-ESR remission was evaluated at the start of study Month 11 and the end of study Month 12. The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR <2.6.|Start of Month 11, End of Month 12|The efficacy evaluable population comprised all participants with a baseline DAS28-ESR and at least one post-baseline measurement of DAS28-ESR.|||Participants|||Number
1435057|NCT00975130|Primary|Number of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Month 6|EULAR response was assessed at the end of Month 6 by the Disease Activity Score using the 28 tender and swollen joint count calculated with erythrocyte sedimentation rate values (DAS28-ESR). A good response was defined as a decrease >1.2 units and a final DAS28-ESR < 3.2 units, while a moderate response was defined as a decrease > 1.2 units and final DAS28-ESR >= 3.2 units, OR a decrease of 0.6 to 1.2 units AND final DAS28-ESR <= 5.1 units|Month 6|The Efficacy Evaluable population in Part 1 of the study excluded participants without a DAS28-ESR at baseline and at least 1 post-line value DAS28-ESR or those that had very poor data quality due to incomplete documentation.|||Participants|||Number
1435058|NCT00975000|Secondary|Time to Parathyroidectomy||56 weeks|Full analysis set who underwent a parathyroidectomy||||||
1435059|NCT00975000|Secondary|Percentage of Participants With a Parathyroidectomy||56 weeks|Full analysis set|||percentage of participants|||Number
1435060|NCT00975000|Secondary|Change From Baseline to the EAP in Urine Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data|||mg/dL||Standard Deviation|Mean
1435061|NCT00975000|Secondary|Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set|||pg/mL||Standard Deviation|Mean
1435062|NCT00975000|Secondary|Change From Baseline to the EAP in Corrected Total Calcium||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set|||mg/dL||Standard Deviation|Mean
1435063|NCT00975000|Secondary|Change From Baseline to Week 52 in eGFR|eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.|Baseline and Week 52|Full analysis set with available data|||mL/min/1.73 m²||Standard Deviation|Mean
1435064|NCT00975000|Secondary|Change From Baseline to the EAP in Mean Serum Phosphorus||Baseline and the EAP (mean of Weeks 22, 24, and 26)|Full analysis set with available data|||mg/dL||Standard Deviation|Mean
1435065|NCT00975000|Secondary|Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck|Bone mineral density (BMD) was measured using dual X-ray absorptiometry (DXA).|Baseline and Week 52|Full analysis set with available data|||percent change||Inter-Quartile Range|Median
1435066|NCT00975000|Primary|Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)||Weeks 21 to 26 (EAP)|Full analysis set (all randomized participants excluding participants determined to have graft failure prior to week 26)|||percentage of participants|||Number
1435067|NCT00974974|Secondary|"On Time Without Troublesome Dyskinesia"|"On time without troublesome dyskinesiais measured by using the Parkinson's disease diary. On time without troublesome dyskinesia describes a period when the participant experiences decreased Parkinsonian symptoms (e.g. immobility or inability to move with ease) without dyskinesia (i.e. difficulty in performing voluntary movements) that affect daily living."|22 weeks|All randomized subjects|||hours||Standard Deviation|Mean
1435068|NCT00974974|Secondary|"Off Time"|"Off time hours is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects|||hours||Standard Deviation|Mean
1435069|NCT00974974|Primary|"Percentage of Off Time During Waking Hours at End of Study"|"Percentage of off time during waking hours at end of study is measured by using the Parkinson's disease diary. Off time describes a period when the participant experiences increased Parkinsonian symptoms (e.g. immobility or inability to move with ease)."|22 weeks|All randomized subjects|||percentage||Standard Deviation|Mean
1435070|NCT00974922|Secondary|Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP.||6 weeks|Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.||||||
1435071|NCT00974922|Primary|Change From Baseline in Ambulatory Diastolic Blood Pressure|The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency.|six weeks|Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.||||||
1435072|NCT00974818|Primary|Response to Treatment|will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.|2 years|Due to a lack of patients accrued to the protocol the protocol was closed and the analysis of the 2 year relapse rates could not be compared.|||participants|||Number
1435073|NCT00974675|Primary|Accumulation Ratio (R0) for CAT-354|Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
1435074|NCT00974675|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state.|Day 0 to Day 147|Safety population included all participants who received at least 1 dose of IMP (CAT-354 or placebo) including those who did not complete the study.|||participants|||Number
1435075|NCT00974675|Primary|Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose||Day 84|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1435076|NCT00974675|Primary|Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose||Pre-dose on Day 56|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1435077|NCT00974675|Primary|Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose||Pre-dose on Day 28|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1435078|NCT00974675|Primary|Volume of Distribution (Vd) for CAT-354 After First Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||mL/kg||Standard Deviation|Mean
1435079|NCT00974675|Primary|Clearance (CL) for CAT-354 After First Dose|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||(mL/day)/kilogram||Standard Deviation|Mean
1435080|NCT00974675|Primary|Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose|Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half.|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||days||Standard Deviation|Mean
1435081|NCT00974675|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||(mcg*day)/mL||Standard Deviation|Mean
1435082|NCT00974675|Primary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||(mcg*day)/mL||Standard Deviation|Mean
1435083|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1435084|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35|PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
1435085|NCT00974675|Primary|Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose||Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21|Pharmacokinetic (PK) population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
1435086|NCT00974571|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435087|NCT00974571|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|End of the first 4 weeks in 6-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435090|NCT00974571|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|"Mean change from baseline in Daytime Nasal Symptoms score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 4 weeks of a 6-week treatment period|All patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435091|NCT00974480|Secondary|Tolerance Evaluated by Investigator.|"Tolerance was studied by evaluating scaling, dryness, erythema and burning/itching sensation on a 5-point scale.~Scaling, Dryness and Erythema Evaluations~- None (0) - Very Severe = (4)~Burning and Itching Evaluation Scale~None (0) = Normal, no discomfort~Mild (1) = Slight discomfort that is not bothersome~Moderate (2) = Discomfort that is somewhat bothersome~Marked (3) = Discomfort that is bothersome and that occasionally interferes with normal daily activities~Severe (4) = Continuous discomfort that interferes with normal daily activities"|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
1435092|NCT00974480|Secondary|Facial Skin Self-evaluation.|A visual analog scale of 13 evaluations were performed by the subject. Scale is from 1 - 10 for each evaluation individually evaluated. 0 = absent, 10 = important.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
1435093|NCT00974480|Secondary|Sensitivity of the Face Evaluated by Subject.|"Sensitivity of the entire face evaluated by the subject was performed using 4 different 10 cm visual analog scales (pruritus, tingling, burning, tightness). Each score was analysed separately.~Each score is from 0 = absent to 10 important."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
1435094|NCT00974480|Secondary|Clinical Skin Evaluation.|A clinical skin evaluation of the face was performed by a dermatologist using 8 scales (skin hydration, radiance, roughness, spots, laxity, skin tone homogeneity, softness, relief (variations in depth)). The individual scores were totalled (worst = 0, best = 47) and the total score was used for analyses.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
1435095|NCT00974480|Secondary|Area Ratio - Analysis of Skin Replicas of Crow's Feet.|An illuminator is used to cross illuminate the specimen (silicone mold replicas) perpendicular to the major lines which accentuate the surface details. The resulting image which consists of a series of shadows that directly correspond to the pattern of wrinkles is digitized for analysis. One can measure changes in skin surface topography by selecting an area range (shadow size) that allows one to directly determine the projected area of the shadowed region associated with the wrinkles and major lines. The Area Ratio is the area of the shadows. The higher the ratio, the greater the wrinkling.|24 weeks|Only the per protocol (PP) population was considered for this analysis. Early termination and lost subjects were excluded from this analysis. Furthermore, some replicas of subjects who completed the study could not be analyzed with precision and were consequently excluded from the analysis by the laboratory.|||mm²||Standard Deviation|Mean
1435096|NCT00974480|Secondary|Skin Elasticity.|Skin elasticity was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin elasticity probe. Pressure required to raise the skin 1mm was recorded. Measurements were performed on the upper cheeks and care was taken to use the same location for all measurements. Final measurements were the average of left and right cheeks. When the product is a moisturizer, lower pressures are indicative of efficacy.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||kilo Pascals||Standard Deviation|Mean
1435097|NCT00974480|Secondary|Skin Hydration (Conductance)|"Skin hydration was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a skin hydration probe.~Measurements were performed in a room with controlled temperature (20°C +/-2) and humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject had been transferred into this room. Care was taken to use the same cheek for each subject throughout the study. Higher values indicate greater hydration."|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||µsiemens (µmho)||Standard Deviation|Mean
1435098|NCT00974480|Secondary|Trans-epidermal Water Loss (TEWL).|Trans Epidermal Water Loss (TEWL) was measured with a DermaLab device (Cortex Technology, Denmark) equipped with a TEWL probe. Measurements were performed with the subject lying down on the back in a room with controlled temperature (20°C +/-2) and relative humidity (45% +/- 15%). All measurements were performed at least 30 minutes after the subject was transferred into this room. The measurements were performed on the cheek. Care was taken to use the same cheek for each subject throughout the study.|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||g / m² / h||Standard Deviation|Mean
1435099|NCT00974480|Secondary|Photographic Evaluation by a Panel of Blinded Dermatologists.|"A blinded panel of two dermatologists had to identify independently which of the two photographs had an improvement or if there was no noticeable difference between them. The two photographs of each subject were randomized to keep the blind.~When the Week 24 photograph was selected as the one showing an improvement, it was scored by the statistician as “improvement”. When the Day 0 photograph was selected as the one showing an improvement, it was scored by the statistician as “worsening”. When there was no noticeable difference between the photographs, it was scored as “stable”."|24 weeks|Analysis was intent to treat (ITT). Photographs taken at early termination visit were not available for every early termination subject as some subjects refused to have their photographs taken. Thus, early termination and lost to follow-up subjects were excluded from this analysis. The total number of subjects included in the ITT analysis was 92.|||Participants|||Number
1435100|NCT00974480|Primary|Skin Aging Measured With the Photonumeric Scale.|Scoring was accomplished by matching each part of the face (forehead, glabella, corners of the mouth, nasal labial fold, crow's feet, below eyes and upper lip) to photographs in the scales and reporting the appropriate number in the tables. All individual scores were added to obtain the total score (Less signs of skin aging = 0, more signs of skin aging = 41.6).|12, 24 weeks|Analysis was intent to treat (ITT) with Last Observation Carried Forward (LOCF) imputation technique.|||Units on a scale||Standard Deviation|Mean
1450584|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of 7-OH-MTX||Day 15||||hours||Full Range|Median
1435101|NCT00974376|Primary|Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period|Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).|12 weeks|Two participants in the gabapentin group and one in the placebo group were lost to follow up after randomization and did not submit any UDS for testing while on study. Two participants in the placebo group withdrew from the study at the week 1 visit, and thus did not submit any UDS for testing while on study.|||percentage of negative UDS||Standard Deviation|Mean
1435102|NCT00974363|Secondary|Antibody Concentrations Against the Vaccine Polysaccharides|Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).|At Month 24 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||μg/mL||95% Confidence Interval|Geometric Mean
1435103|NCT00974363|Secondary|Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides|Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).|At Month 24 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
1435104|NCT00974363|Secondary|Antibody Titers Against the Vaccine Meningococcal Serogroups|Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals’ laboratory.|At Months 24, 36, 48 and 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Titers||95% Confidence Interval|Geometric Mean
1435105|NCT00974363|Secondary|Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups|A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England`s (PHE) laboratory and at GSK Biologicals’ laboratory.|At Months 24, 36, 48 and 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
1435106|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 60 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
1435107|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 48 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
1435108|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England`s (PHE) laboratory.|At Month 36 post primary dose|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
1435109|NCT00974363|Primary|Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups|A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals’ laboratory.|At Month 24 post primary dose|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.|||Subjects|||Number
1435110|NCT00974311|Secondary|Percentage of Participants With Circulating Tumor Cell (CTC) Conversion|CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.|Baseline up to 3 years|CTC Evaluable Population.|||percentage of participants||95% Confidence Interval|Number
1450585|NCT00847886|Primary|7-Hydroxymethotrexate (7-OH-MTX) Maximum Plasma Concentration|7-OH-MTX is the primary metabolite of methotrexate.|Day 15||||ng/mL||Standard Deviation|Mean
1435111|NCT00974311|Secondary|European Quality of Life Five-Domain (EQ-5D) Scale|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scale (1= no problems, 2= some/moderate problems and 3= severe problem). Score were transformed and resulted in a total EQ-5D score range of 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health and quality of life.|Week 13|Evaluable Intent to Treat. Participants who were part of the ITT Population and who were evaluable for EQ-5D.|||units on a scale||Standard Deviation|Mean
1435112|NCT00974311|Secondary|Percentage of Participants With Soft-tissue Objective Response|The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the investigators’ response assessments and also the derived response assessments by treatment group. Only participants with measurable soft tissue disease at screening were included in this analysis. Participants with measurable disease at screening are participants who had at least 1 target lesion identified per RECIST v1.1 at screening. Percentage of participants summarizes the number of participants with complete or partial objective response (%). Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.|During study period (up to 3 years)|Intent to Treat (ITT) with Measurable Disease. Participants who were part of the ITT Population and had measurable soft tissue disease at screening, defined by at least 1 target lesion according to RECIST v1.1.|||Percentage of participants|||Number
1435113|NCT00974311|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|Participants were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.|During study period (up to 3 years)|Evaluable Intent to Treat. Participants who were part of the ITT Population and had a PSA level measured at baseline and at least 1 post-baseline assessment.|||Percentage of participants|||Number
1435114|NCT00974311|Secondary|Percentage of Participants With Pain Palliation|The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as >=30% reduction in average pain score at Week 13 compared to baseline without a >=30% increase in analgesic use.|Baseline up to 3 years|Evaluable ITT Population. Participants with metastatic bone disease at baseline; provided answers to Question #3 of the Brief Pain Inventory – Short Form for a minimum of 4 out of 7 days in the baseline run-in period; stable baseline pain; stable analgesic use; and had an average pain score during the baseline run-in period of ≥ 4.|||Percentage of participants||95% Confidence Interval|Number
1435115|NCT00974311|Secondary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).|Baseline and at every study visit from week 13 while on study drug (up to 3 years)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
1435116|NCT00974311|Secondary|Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)|The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.|Baseline up to 3 years|Evaluable intent to treat (ITT) - all participants who were part of the ITT population and had a global FACT-P score at baseline and at least 1 post-baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
1435117|NCT00974311|Secondary|Time to First Skeletal-related Event|The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.|During study period (up to 3 years)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
1435118|NCT00974311|Secondary|Radiographic Progression-free Survival|Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Participants who did not reach the endpoint were right censored at their last assessment.|During study period (up to 3 years)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
1435119|NCT00974311|Primary|Overall Survival|Survival is defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cutoff date (this included participants who were known to have died after the data analysis cutoff date).|During study period (up to 3 years)|ITT included all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
1435120|NCT00974246|Primary|Pulmonary Function FEC/FVC Ratio at 16 Weeks|To measure whether pulmonary function, determined by the ratio between FEC (Forced Expiratory Capacity) and FVC (Forced Vital Capacity), improved during 16 weeks of Advair Diskus administration.|16 weeks||||ratio||Standard Deviation|Mean
1435121|NCT00974246|Primary|To Determine if Changes in Pulmonary Function (FEC/FVC) Were Associated With a Reduction in Depression as Assessed by Using the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0 During Advair Diskus Treatment.|FEC is Forced Expiratory Capacity and FVC is Forced Vital Capacity. The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks||||units on a scale||Standard Deviation|Mean
1435122|NCT00974246|Primary|To Determine the Effect of Treating COPD Patients With Advair Diskus for 16 Weeks on the Cornell Depression Scale or Section D SUM of the Minimum Data Set 3.0|The Cornell Depression Scale ranges from 0-38, with a score 12 points or more indicating probable depression. Section D SUM o f the Minimum Date Set 3.0 is an assessment tool of health status for all residents (regardless of payer) of long-term care facilities certified to participate in Medicare or Medicaid. Scores range from 0 to 27, with a higher score indicating more depression.|16 weeks||||units on a scale||95% Confidence Interval|Mean
1435123|NCT00974233|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|Overall survival (OS) was measured for all enrolled subjects as the time from the day of first study drug administration until death from any cause.|||months||95% Confidence Interval|Median
1435124|NCT00974233|Secondary|Toxicities Observed With Induction Chemotherapy and Maintenance Therapy|Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.|||participants|||Number
1435125|NCT00974233|Secondary|Objective Response Rate (Complete + Partial Responses)|Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)||||participants|||Number
1435126|NCT00974233|Primary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)||||Proportion of participants||95% Confidence Interval|Median
1435127|NCT00974233|Primary|Progression Free Survival|The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).|42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)|The study was designed to test the null hypothesis that the median PFS with induction BR and maintenance lenalidomide is at most 18 months versus the alternative hypothesis that median PFS is >18 months, at a one-sided significance level of 0.10 with a power of 80%.|||months||95% Confidence Interval|Median
1435128|NCT00974220|Secondary|Cycle Exercise Endurance Time|Constant workrate cycle endurance during tests at 75% of the peak incremental workrate|10-minutes post-treatment|Subjects completing both treatment arms were included in this analysis|||minutes||Standard Error|Mean
1435129|NCT00974220|Primary|Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise|"The 10-point Borg scale ranges from 0 nothing at all to 10 maximal/extremely strong and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests."|10-minutes post-treatment|Subjects who completed both treatment arms of the crossover study were included in the primary analysis.|||units on a scale||Standard Error|Mean
1435130|NCT00974142|Secondary|Effects of Cyclosporin A on Symptoms - Change in Scores on a Shortness of Breath Scale|Scores on a shortness of breath scale (University of California at San Diego Dyspnea scale): shortness of breath questionnaire scores are summed as a total score ranging from 0-120 with higher scores indicating more severe breathlessness. Assessments were performed at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||units on a scale||Full Range|Median
1435283|NCT00972543|Secondary|Haematology Laboratory Assessments - Neutrophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435131|NCT00974142|Secondary|Effects of Cyclosporin A on Respiratory Function - Change in Exercise Capacity by a Shuttle Walk Distance Measured in Feet|Measurement of exercise capacity by a shuttle walk distance measured in feet at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). The purpose of the shuttle walk test is to see how far and fast a patient can walk (without stopping for a rest) by following a series of time signals.Values expressed as median (full range).|at Week 8 and Week 16||||feet||Full Range|Median
1435132|NCT00974142|Secondary|Effects of Cyclosporin A on Respiratory Function - Change in the Percentage of Post Predicted Value of Forced Expiratory Volume in 1 Second|Outcome measured the change in the percentage of post predicted value of forced expiratory volume in 1 second at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||Percentage of post predicted value||Full Range|Median
1435133|NCT00974142|Secondary|Effects of Cyclosporin A on Respiratory Function - Change in the Percentage of Post Predicted Value of Forced Vital Capacity|Outcome measured the change in the percentage of post predicted value of forced vital capacity at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||Percentage of post predicted value||Full Range|Median
1435134|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8+ Tumor Necrosis Factor|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - CD8+ tumor necrosis factor at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
1435135|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 4+ Interleukin-2|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - cluster of differentiation 4+ interleukin-2 at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
1435136|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8+ Interferon Gamma|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - CD8+interferon gamma at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
1435137|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over Treatment Interval - Change in the Percentage of Cluster of Differentiation 8 and Major Histocompatibility Complex II|Outcome measured the change in the percentage of peripheral blood cells expressing biomarker - cluster of differentiation 8 (CD8), major histocompatibility complex (MHC) II at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
1435138|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over 16 Week Treatment Interval - Change in the Percentage of Cluster of Differentiation 8 and Cluster of Differentiation 28|Outcome measured the change in the percentage of peripheral blood T cell biomarkers - cluster of differentiation 8 (CD8), cluster of differentiation 28 (CD28) at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
1435139|NCT00974142|Secondary|Peripheral Blood T Cell Biomarkers Over 16 Week Treatment Interval - Change in the Percentage of Cluster of Differentiation 4 (CD4)|Outcome measured the change in the percentage of cluster of differentiation 4 (CD4) at midpoint assessment (Week 8) and at the conclusion of treatment (Week 16). Values expressed as median (full range).|at Week 8 and Week 16||||% of cells expressing biomarkers||Full Range|Median
1435140|NCT00974142|Secondary|Pharmacokinetic - Pharmacodynamic Relationship of Oral Cyclosporine and Biomarkers of an Adaptive Immune Response - Cyclosporine Blood Levels|Cyclosporine blood levels on therapy over 16 week treatment interval were measured at Weeks 2, 4, 6, 8, 10, 12 & 16. The median for each participant was found and then the overall median was determined. Values expressed as median (full range).|16 weeks|Cyclosporine blood levels were not analyzed in placebo group.|||ng/mL||Full Range|Median
1435141|NCT00974142|Primary|Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients - Number of Patients That Developed Infection Requiring Systemic Antibiotic Therapy|Clinical diagnosis of infection which requires systemic antibiotic therapy during the 16 week study interval at Week 2, 4, 6, 8, 10, 12 and 16. Outcome measured the number of subjects who developed an infection requiring systemic antibiotic therapy during the study treatment interval.|16 weeks||||Participants|||Count of Participants
1435142|NCT00974142|Primary|Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients - Number of Patients That Developed Renal Insufficiency|Development of renal insufficiency defined as > 30% elevation in serum creatinine above baseline which required dose modification of the cyclosporine over 16 week treatment interval at Week 2, 4, 6, 8, 10, 12 and 16. Outcome measured the number of subjects who developed renal insufficiency during the study treatment interval.|16 weeks||||Participants|||Count of Participants
1435143|NCT00974142|Primary|Safety Profile of Oral Cyclosporin A Immunotherapy in Advanced Stage Chronic Obstructive Pulmonary Disease Patients- Nephrotoxicity - Measured by Serum Creatinine|Measurement of nephrotoxicity by monitoring serum creatinine over 16 week treatment interval. Mean serum creatinine values were assessed at Week 2, 4, 6, 8, 10, 12 and 16. The mean values of all measurements for each participant were calculated and then the mean across participants was calculated. Values expressed as mean ± SD.|16 weeks||||mg / dL||Standard Deviation|Mean
1435144|NCT00974090|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg / dL||Standard Error|Least Squares Mean
1450586|NCT00847886|Primary|Amount of Methotrexate Excreted in the Urine||Day 15||||µg||Standard Deviation|Mean
1450587|NCT00847886|Primary|Half-life of Methotrexate in Plasma||Day 15||||hours||Standard Deviation|Mean
1435145|NCT00974090|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg・hr/dL||Standard Error|Least Squares Mean
1435146|NCT00974090|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||mg / dL||Standard Error|Least Squares Mean
1435147|NCT00974090|Primary|Change From Baseline in HbA1c at Week 12|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 12|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last postbaseline double-blind observed value was carried forward and used for Week 12 where data was missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1435148|NCT00974051|Primary|Blood Glucose Nadir|BG nadir overnight after intervention|overnight hours||||mg/dl||Standard Deviation|Mean
1435149|NCT00974051|Secondary|Percent of Nighttime Glucose Levels >250 mg/dl||10:00pm to 6:00am||||percentage of overnght glucose values|||Number
1435150|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <70||10:00pm to 6:00am||||percentage of nighttime glucose values|||Number
1435151|NCT00974051|Secondary|Percent of Nighttime Glucose Levels <80||9:00pm to 6:00am||||percentage of overnight glucose levels|||Number
1435152|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the QCA and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||mm||Standard Deviation|Mean
1435153|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||percentage of correct decision by QCA|||Number
1435154|NCT00973921|Secondary|Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .|The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.|On day of procedure|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||mm||Standard Deviation|Mean
1435155|NCT00973921|Primary|The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.|IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.|On the procedure day|Total of 40 consecutive patients who underwent PCI with stent implantation were enrolled. Only 31 of them had analyzable IVUS results.|||percentage of correct decisions by SO|||Number
1435156|NCT00973765|Primary|Treatment Failures at 7 Days|worsening abscess or new recurrence of abscess|7 days||||participants|||Number
1435157|NCT00973752|Primary|Overall Survival at One Year|The number of participants alive one year after baseline.|1 years||||Participants|||Count of Participants
1435158|NCT00973739|Secondary|Participants Experiencing Grade 3 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year||||participants|||Number
1435159|NCT00973739|Secondary|Participants Experiencing Grades 1 or 2 Toxicities (CTCAE)|Toxicity was assessed throughout the study, up to one year.|Baseline through one year||||participants|||Number
1435160|NCT00973739|Secondary|Estimated Volumetric Progression Free Survival for Hearing at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of hearing progression. PFS was analyzed using the Kaplan–Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.~Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan–Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.|||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
1435161|NCT00973739|Primary|Estimated Volumetric Progression Free Survival at 12 Months|"Measurements were taken every three months, up to one year. Estimated volumetric progression free survival (PFS) was measured from date of enrollment to date of volumetric progression. PFS was analyzed using the Kaplan–Meier method in terms of overall PFS (volumetric or hearing progression), volumetric progression, and hearing progression.~Point estimates for PFS with 95% confidence intervals (CIs) were calculated from Kaplan–Meier curves."|Every three months for one year|This analysis is based on the 17 evaluable patients.|||Liklihood of PFS at 12 months||95% Confidence Interval|Mean
1435162|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).~Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.~The analyses were performed on the safety set."|7 days after each vaccination|The analysis is done on the safety set.|||Number of subjects|||Number
1435163|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).~Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.~Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination."|7 days after each vaccination|The analysis is done on the safety set.|||Number of subjects|||Number
1435164|NCT00973700|Secondary|Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age|"Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).~Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination"|7 days after each vaccination|The analysis is done on the safety set.|||Number of subjects|||Number
1435165|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the per-protocol set (PPS)."|7 days and 21 days after each vaccination|The analysis is done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
1435166|NCT00973700|Secondary|HI GMR, in Adults 18 to 64 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.|||Ratio||95% Confidence Interval|Geometric Mean
1435167|NCT00973700|Secondary|HI GMRs, in 3 to <9 Years and 9 to 17 Years|"Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).~The analyses were performed on the the per-protocol set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.|||Ratio||95% Confidence Interval|Geometric Mean
1435168|NCT00973700|Secondary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis is done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
1435169|NCT00973700|Secondary|Age Distribution at Baseline||Baseline|The overall number of baseline participants.|||years||Standard Deviation|Mean
1435170|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~Analyses were performed on the Per-Protocol set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
1435171|NCT00973700|Primary|Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age|"Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.~The analyses were performed on the Per-Protocol Set (PPS)."|Day 1 to day 387|The analysis was done on the per-protocol set.|||Percentages of Subjects||95% Confidence Interval|Number
1435172|NCT00973622|Primary|A Difference Score for the Log Value of K.|K is a output value, a summary statistic, derived from a hyperbolic function that summarizes the rate at which monetary values are discounted according to the time they are received. The value of K can either increase or decrease from its baseline value. For example, an increase in K would indicate that the participant is choosing to receive larger amounts of money at a later point in time. A decrease would suggest the opposite - lesser amounts of money at an earlier point in time). The difference score is calculated from baseline to that immediately after 10 or 20 Hz rTMS.|baseline and immediately after stimulation, an average of 25 seconds.|All participants that attended at least one session and provided at least some outcome data were included in the analyses|||log transformed values of K||Standard Deviation|Log Mean
1435173|NCT00973479|Secondary|Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24.|Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Scores on a scale||Standard Deviation|Mean
1435174|NCT00973479|Secondary|Proportion of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24|An ACR 50 response is defined as a greater than or equal to 50 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS) (0-10 cm) b. Participant's global assessment of disease activity by VAS (0-10 cm) c. Physician's global assessment of disease activity by VAS (0-10 cm) d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.|Week 24|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Percentage of Participants|||Number
1435175|NCT00973479|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14|The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). HAQscore on a scale ranges from 0 (no disability) to 3 (completely disabled). Higher scores indicate worsening.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Scores on a scale||Standard Deviation|Mean
1435176|NCT00973479|Secondary|Proportion of Participants With Moderate or Good Response in Disease Activity Index Score 28 (DAS28) Using C-reactive Protein (CRP) at Week 14|"DAS28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis combining tender joints (28 joints), swollen joints (28 joints), CRP, and participant’s global assessment of disease activity. The DAS28 score ranges from 0 (best) to 10 (worst). DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Higher scores indicate worsening. A decrease in DAS28 score >1.2 is being referred to as a good response and a decrease of 0.6-1.2 as a moderate response."|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Percentage of Participants|||Number
1435177|NCT00973479|Primary|Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14|An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen (66 joints) and tender (68 joints) joint counts; 2. greater than or equal to 20 percentage improvement in at least 3 of the following 5 assessments: a. Participant's assessment of pain by Visual Analog Scale (VAS), (0 [no pain] to 10 [worst pain]) b. Participant's global assessment of disease activity by VAS c. Physician's global assessment of disease activity by VAS d. Participant's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C-reactive protein.|Week 14|Intent-to-treat: all patients analyzed according to the treatment for which they were randomized.|||Percentage of Participants|||Number
1435178|NCT00973362|Secondary|ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)|ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay|Baseline Evaluation|74 women with Aptima HPV assay results did not have FDA-Approved HPV DNA test results primarily due to insufficient volume of the cytology specimen for an N of 865 results for the FDA-Approved HPV DNA assay compared to 939 results for the Aptima HPV assay.|||participants|||Number
1435179|NCT00973362|Secondary|ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)|ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)|Baseline Evaluation||||participants|||Number
1435180|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct Study Arm: 30+ yrs. Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation|18 women with Aptima HPV results did not have FDA-Approved DNA test results due to insufficient volume of the cytology specimen for a N of 801 compared to a N of 819 for the Aptima HPV assay results.|||participants|||Number
1435181|NCT00973362|Primary|Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+|Baseline Evaluation||||participants|||Number
1435182|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.|||Participants|||Number
1435183|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.|||Participants|||Number
1435184|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The analysis was on the safety set.|||Participants|||Number
1435185|NCT00973349|Secondary|Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age|Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.|7 days after vaccination|The population used in analysis was the safety set|||Participants|||Number
1435186|NCT00973349|Secondary|Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.|21 days after vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CHMP criteria, 18 to 60 years and over 60 years of age.|||Geometric Mean Ratio||95% Confidence Interval|Geometric Mean
1435187|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.|||Participants|||Number
1435188|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age|Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.|||Participants|||Number
1435189|NCT00973349|Secondary|Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age|Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.|21 days after each vaccination|The analysis was on the per protocol set.|||Participants|||Number
1435190|NCT00973349|Secondary|Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age|Geometric mean hemagglutinin inhibition (HI) titer = GMT|21 days after each vaccination|The analysis was on the per protocol set. For this analysis, total subjects enrolled were stratified and randomized in two age groups, according to the CBER criteria, 18 to 64 years and over 64 years of age.|||Geometric Mean Titer||95% Confidence Interval|Geometric Mean
1435191|NCT00973349|Primary|Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age|Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.|21 days after each vaccination|The analysis was based on the per protocol population.|||Participants|||Number
1435192|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): bone formation marker [bone-specific alkaline phosphatase (bALP) ].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||U/L||Full Range|Median
1435193|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA) bone formation marker [bone-specific alkaline phosphatase (bALP)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||U/L||Full Range|Median
1435194|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery) after 18 months post VD|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
1435195|NCT00972959|Secondary|New Skeletal-related Events (SRE: Pathologic Fractures, Need for Bone Radiation Therapy or Surgery)|New Skeletal-related events (SRE: pathologic fractures, need for bone radiation therapy or surgery) following 8 cycles (day 168) of therapy|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
1435196|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] every 6 months for up to 18 months|18 months|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
1435197|NCT00972959|Secondary|Skeletal Survey for New Osteolytic Lesions/Fractures|Skeletal survey was measured using conventional radiography [imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)] on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||participants|||Number
1435198|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 8 (day 168).~Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The VAS for Bone Pain was constructed as follows:~None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||units on a scale||Full Range|Median
1435199|NCT00972959|Secondary|Bone Pain|"Bone pain was measured with the use of the Visual Analogue Scale on day 21 of cycle 4 (day 84).~Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.~The VAS for Bone Pain was constructed as follows:~None Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome."|On the day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||units on a scale||Full Range|Median
1435200|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 8 (day 168) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation marker [osteocalcin (OC)].|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||ng/ml||Full Range|Median
1435201|NCT00972959|Secondary|Bone Remodelling|Bone remodelling was studied by the measurement of the following serum indices on day 21 of cycle 4 (day 84) using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation markers [osteocalcin (OC)].|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||ng/ml||Full Range|Median
1435202|NCT00972959|Secondary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1–L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner on day 21 of cycle 8 (day 168)|day 168|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||T-score||Full Range|Median
1435203|NCT00972959|Primary|Bone Mineral Density (BMD)|BMD of the lumbar spine (L1–L4, anteroposterior view) and femoral neck (FN) was measured by dual energy X-ray absorptiometry (DXA) using a Hologic QDR-1000 scanner on day 21 of cycle 4 (day 84)|day 84|Out of the 17 patients enrolled 12 patients completed the 8 VD cycles, 2 patients 6 VD cycles (due to peripheral neuropathy), 1 patient 5 VD cycles (and then progressed) and 2 patients died after receiving 1 and 2 VD cycles (respectively)|||T-scores||Full Range|Median
1435204|NCT00972816|Secondary|Number of Participants Reporting Unsolicited Adverse Events (AEs)|Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)|Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination|The analysis was done on unsolicited safety set population.|||Subjects|||Number
1435205|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination|Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)|7 days after second vaccination|The analysis was performed on safety set population|||Participant|||Number
1435206|NCT00972816|Secondary|Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination|Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).|7 days after first vaccination|The analysis was performed on safety set population|||Participants|||Number
1435207|NCT00972816|Secondary|Geometric Mean Titers (GMTs) Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.~Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10)."|Day 1, Day 22, Day 29, Day 43||||Titers||95% Confidence Interval|Geometric Mean
1435208|NCT00972816|Secondary|Antibody Response Based on Baseline Seropositivity|"Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.~Subgroups with baseline HI titer < 1:10: PPS Day 1–29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.~Subgroups with baseline HI titer ≥ 1:10: PPS Day 1–29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29 and Day 43||||percentage of Subjects||95% Confidence Interval|Number
1435209|NCT00972816|Secondary|Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010|"Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines~Subgroups without recent seasonal flu vaccine:~PPS Day 1, Day 1–22 and Day 1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.~Subgroups with recent seasonal flu vaccine:PPS Day 1–22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.~PPS Day 1–29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively"|Day 1, Day 22, Day 29, Day 43|The analysis was done on PPS population.|||Titers||95% Confidence Interval|Geometric Mean
1435210|NCT00972816|Secondary|Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.|HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1–22 and Day1–43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1–29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.|Day 22, Day 29, Day 43|The analysis was done on PPS population|||percentage of Subjects||95% Confidence Interval|Number
1435211|NCT00972816|Secondary|Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group|"Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.~PPS Day1–29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1–202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population|||Titers||95% Confidence Interval|Geometric Mean
1435212|NCT00972816|Primary|Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations|"HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.~PPS Day 1–29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.~PPS Day 1–202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.~PPS Day 1–387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively."|Day 22, Day 29, Day 43, Day 202 and Day 387|The analysis was performed on per protocol set (PPS) population|||percentage of subjects||95% Confidence Interval|Number
1435217|NCT00972738|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period|Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire, which included 28 questions on a 7-point scale [Score 0 (best) to 6 (worst)], across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.|Baseline and at the end of 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and a week 2 measurement were included. No missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435218|NCT00972738|Secondary|Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435219|NCT00972738|Secondary|Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.|End of the 2-week treatment period|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435220|NCT00972738|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435221|NCT00972738|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435222|NCT00972738|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period|Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and over the 2-week treatment period|The primary efficacy analyses were based on intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1435223|NCT00972725|Secondary|Anti- RT, Nef, p17, p24 and F4co Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs), given in milli-enzyme-linked immunosorbent assay (ELISA) units per millilitre (mEL.U/mL).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||mEL.U/mL||95% Confidence Interval|Geometric Mean
1435224|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435225|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435226|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435284|NCT00972543|Secondary|Haematology Laboratory Assessments - Platelets|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435227|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD4+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435228|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435229|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435230|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435231|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435232|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435233|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435234|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435235|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD4+ T Cells Expressing at Least 2 Markers/ Cytokines|Cytokine/marker co-expression profile was defined as the antigen-specific CD4+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435236|NCT00972725|Secondary|Magnitude of Antigen Specific CD4+ T Cells Expressing at Least 2 Cytokines|Magnitude was defined as the frequency of CD4+ T cells group-specific antigen (Gag) proteins 17, 24, negative regulatory factor (Nef), reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435237|NCT00972725|Secondary|Number of Subjects With Frequency of Cluster of Differentiation (CD4+) T Cells Expressing at Least 2 Cytokines to at Least 1, 2, 3 or All 4 Antigens|Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1435238|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1441669|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||μU/μL||Standard Deviation|Mean
1435239|NCT00972725|Secondary|Frequency of Antigen (F4co_est) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435240|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435241|NCT00972725|Secondary|Frequency of Antigen (pool_F4co) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS. Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est).|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435242|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435243|NCT00972725|Secondary|Frequency of Antigen (p24) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435244|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435245|NCT00972725|Secondary|Frequency of Antigen (p17) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435246|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435247|NCT00972725|Secondary|Frequency of Antigen (Nef) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435248|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or CD40-L cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435249|NCT00972725|Secondary|Frequency of Antigen (RT) Specific CD8+ T Cells Expressing at Least One Marker/ Cytokine|Cytokine/marker co-expression profile was defined as the antigen-specific CD8+ T cells expressing IL-2 and/or TNF-α and/or IFN-γ and/or cluster of differentiation 40-ligand (CD40-L) cytokines as determined by ICS.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435250|NCT00972725|Secondary|Magnitude of Antigen Specific CD8+ T Cells Expressing at Least One Cytokine|Magnitude was defined as the frequency of CD8+ T cells group-specific antigen (Gag) proteins 17, 24; negative regulatory factor (Nef); reverse transcriptase (RT) and fusion protein of all 4 antigens (F4co). Determination of F4co was done by stimulating the F4 antigen with a peptide pool spanning (pool_F4co) or by adding individual frequencies of the CD8+ T cell response to each of the 4 antigens (F4co_est). Among the cytokines expressed were IL-2, TNF-α and INF-γ.|At Day 0, 7, 14, 30 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1435251|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 180|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435252|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 30|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435253|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435254|NCT00972725|Primary|Levels of Haematological and Biochemical Parameters|Among haematological and biochemical parameters determined were alanine aminotransferase [ALT], aspartate aminotransferase [ASA], basophils [BASO], creatinine [CREA], eosinophils [EOS], haematocrit [HAEM], haemoglobin [HAEMO], lymphocytes [LYMPH], monocytes [MONO], neutrophils [NEU], platelets [PLA], red blood cells [RBC], urea [UR] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – unknown, below, within and above.|At Day 0|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435255|NCT00972725|Primary|Number of Subjects With AEs of Specific Interest and Immune-Mediated Disorders (IMDs)|Adverse events of specific interest include auto-immune diseases (AID) and immune mediated disorders such as neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events.|During the entire study period (from Day 0 up to Day 360)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435256|NCT00972725|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 360)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435257|NCT00972725|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 32 Day (Days 2-29) post-chloroquine administration and during the 30 Day (Days 0-29) post-vaccine administration period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435258|NCT00972725|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7 Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435259|NCT00972725|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7 Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435260|NCT00972725|Primary|Number of Subjects With Frequency of Cluster of Differentiation 8 (CD8+) T Cells Expressing at Least One Cytokine to at Least 1, 2, 3 or All 4 Antigens|Among expressed cytokines were interleukin-2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (INF-γ), as determined by intracellular cytokine staining (ICS).|At Day 14|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
1435285|NCT00972543|Secondary|Haematology Laboratory Assessments - White Cell Count|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435261|NCT00972621|Secondary|Postoperative Mean Endothelial Cell Count|mean endothelial cell count (measured by Konan specular microscope) at 3 months|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting mean endothelial cell count for ITT population, which differs from the safety population used in the Participant Flow.|||number of endothelial cells||Standard Deviation|Mean
1435262|NCT00972621|Primary|Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively|Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.|3 months postoperative|Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting IOP spikes ≥ 30 mmHg for ITT population, which differs from the safety population used in the Participant Flow.|||percentage of participants||90% Confidence Interval|Number
1435263|NCT00972595|Primary|Peak Plasma Concentration (Cmax) for Ondansetron||24 hours post-dose|All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis.|||ng/mL||Standard Deviation|Least Squares Mean
1435264|NCT00972595|Primary|Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose|All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Least Squares Mean
1435265|NCT00972543|Secondary|Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)||||participants|||Number
1435266|NCT00972543|Secondary|Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test|A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.|Measured at screening (Day -14 to Day -1)||||participants|||Number
1435267|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - C Reactive Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435268|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435269|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435270|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Alanine Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435271|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Aspartate Transaminase|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435272|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Calcium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435273|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Protein|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435274|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Total Bilirubin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435275|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Creatinine|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435276|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Urea|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435277|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Potassium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435278|NCT00972543|Secondary|Clinical Chemistry Laboratory Assessments - Sodium|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435279|NCT00972543|Secondary|Haematology Laboratory Assessments - Basophils|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1437724|NCT00951912|Primary|Percentage Change in Total Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
1435287|NCT00972543|Secondary|Haematology Laboratory Assessments - Haematocrit|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435288|NCT00972543|Secondary|Haematology Laboratory Assessments - Haemoglobin|Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits||||participants|||Number
1435289|NCT00972543|Secondary|Weight Measurements||Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
1435290|NCT00972543|Secondary|Temperature||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study||||||
1435291|NCT00972543|Secondary|Arterial Blood Pressure||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study||||||
1435292|NCT00972543|Secondary|Heart Rate||Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits|Results not analysed due to early termination of the study||||||
1435293|NCT00972543|Secondary|Complaint Directed Physical Examinations|Number of participants undergoing complaint directed physical examinations|Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)|Results not analysed due to early termination of the study||||||
1435294|NCT00972543|Secondary|Participants With Direct Physical Examination Abnormalities|Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum|Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits|Results not analysed due to early termination of the study||||||
1435295|NCT00972543|Primary|Dynamic Physician's Global Assessment of Change (dPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
1435296|NCT00972543|Primary|Static Physician Global Assessment (SPGA)|The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse|Measured at Screening, Day 0 and Day 7|Results not analysed due to early termination of the study||||||
1435297|NCT00972543|Primary|Psoriasis Area and Severity Index (PASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
1435298|NCT00972543|Primary|Static Physician Global Assessment Hands and Feet (sPGA – H&F)|Minimum possible score 0, maximum possible score 4.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit|Results not analysed due to early termination of the study||||||
1435299|NCT00972543|Primary|Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)|Minimum possible score 0, maximum possible score 72.|Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits|Results not analysed due to early termination of the study||||||
1435300|NCT00972530|Primary|Relapse of Arthritis|The patients were followed for six months and if signs and symptoms recurred in between the patients were told to contact the rheumatology department. In such cases the elbow was re-examined and if a relapse could be confirmed the duration of effect was recorded and if needed the patient was offered another injection.|Regular visits at one week, 3 months and 6 months.||||participants|||Number
1435301|NCT00972504|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or is associated with liver injury and impaired liver function defined as: alanine aminotransferase >=3 times upper limit of normal (ULN), and total bilirubin >=2 times ULN or international normalized ratio more than 1.5.|approximately up to 63 days|All Subjects population.|||Participants|||Number
1435302|NCT00972504|Secondary|Mean Forced Expiratory Volume in 1 Second (FEV1)|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. FEV1 was measured at pre-challenge, 60, 120, 180, 240, 300 and 360 minutes.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Liters||Standard Deviation|Mean
1435303|NCT00972504|Secondary|Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal congestion was measured on 0-10 centimeter VAS scale (0: no symptoms and 10: the worst possible symptoms) with low score indicates well-being and higher values indicate greater congestion. It was measured at 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes. The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1435304|NCT00972504|Secondary|Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Wet tissue weight assessments was measured as a surrogate marker of nasal secretion at 60, 120, 180, 240, 300 and 360 minutes. The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Grams||95% Confidence Interval|Least Squares Mean
1435305|NCT00972504|Secondary|Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed to produce the TNSS at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1435306|NCT00972504|Primary|Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3|On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.|Day 3 of each treatment period (approximately up to 63 days)|The all subjects population was used defined as all participants who receive at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||95% Confidence Interval|Least Squares Mean
1435307|NCT00972478|Secondary|Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to week 26|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1435308|NCT00972478|Secondary|Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to week 26|Eligible patients who received the protocol treatment in the Phase II portion of the study|||percentage of participants||95% Confidence Interval|Number
1435309|NCT00972478|Secondary|Overall Survival (Phase II)|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.|||percentage of participants||95% Confidence Interval|Number
1435310|NCT00972478|Primary|Progression-free Survival (Phase II)|From date of registration to date of first documentation of progressive disease, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 2 years|Eligible patients who received the protocol treatment in the Phase II portion of the study.|||percentage of participants||95% Confidence Interval|Number
1435311|NCT00972478|Primary|Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)|Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).|21 days|Phase I eligible patients receiving any amount of the assigned dose during Cycle 1 (1 Cycle = 21 days) or whom developed a dose-limiting toxicity (DLT).|||mg PO Once daily Days 1-9|||Number
1435312|NCT00972439|Primary|Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups|Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells|32 weeks|Five of the breast biopsy specimens contained insufficient TDLU epithelial tissue for analysis and one of the remaining women was diagnosed with a follicular cyst on the day of the biopsy, leaving 27 evaluable women.|||Percent of cells staining for Ki67||95% Confidence Interval|Mean
1435313|NCT00972374|Other Pre-specified|Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit|IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.|12 Months|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1435314|NCT00972374|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, Month 3|Intent to Treat: all randomized patients|||Number of Letters Read Correctly||Standard Deviation|Mean
1450588|NCT00847886|Primary|Time to Reach Maximum Plasma Concentration of Methotrexate||Day 15||||hours||Full Range|Median
1435315|NCT00972374|Primary|Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.|Month 3|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1435316|NCT00972335|Secondary|To Correlate the Activity of This Treatment Regimen With Expression of Selected Intra-tumoral Biomarkers.||18 months|||||||
1435317|NCT00972335|Secondary|To Evaluate the Toxicity of Bevacizumab/Everolimus in Patients With Recurrent Meningioma.||18 months|Includes all treated patients (one patient not treated)|||participants|||Number
1435318|NCT00972335|Primary|Progression-free Survival (PFS), in the Treatment of Patients With Refractory Meningioma.|Progression-free survival (PFS) is defined as the time from randomization until objective tumor progression (PD) or death. Progression is defined per MacDonald criteria for response as ≥25% increase in size of enhancing tumor or any new tumor on MRI scan, neurologically worse, and steroids stable or increased.|18 months|Includes all enrolled and treated patients (one patient not treated)|||months||95% Confidence Interval|Median
1435319|NCT00972322|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Day 28|All participants who received at least one dose of the investigational drug.|||Participants|||Number
1435320|NCT00972322|Primary|Number of Participants Who Experienced Serious or Non-serious Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Up to Day 31|All participants who received at least one dose of the investigational drug.|||Participants|||Number
1435321|NCT00972322|Primary|Change From Baseline in the 24-hour Weighted Mean Glucose (WMG)|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose."|Baseline and Day 28|All participants who were compliant with the study procedures and have available data from at least one treatment were included in the primary analysis dataset.|||mg/dL||Standard Deviation|Least Squares Mean
1435322|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1435323|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 52 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
1435324|NCT00972283|Primary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject’s daily activities. Moderate AEs: marked symptoms, moderate interference with subject’s daily activities. Severe AEs: considerable interference with subject’s daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
1435325|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 78 + 7 days follow up|The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1435356|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 16 and Week 32 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 16 and Week 32|Participants received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
1450589|NCT00847886|Primary|Methotrexate Maximum Plasma Concentration||Day 15||||ng/mL||Standard Deviation|Mean
1435326|NCT00972283|Primary|Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 78 + 7 days follow up|Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.|||Episodes/100 years of patient exposure|||Number
1435327|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 78|Mean of the SMPG at 78 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am, before breakfast.|Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1435328|NCT00972283|Secondary|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52|Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.|Week 52|The FAS included all randomised subjects and missing data was imputed using LOCF. For 36 subjects all 9-point SMPG values were missing.|||mmol/L||Standard Deviation|Mean
1435329|NCT00972283|Secondary|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment|Change from baseline in HbA1c after 78 weeks of treatment|Week 0, Week 78|The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1435330|NCT00972283|Primary|Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment|Week 0, Week 52|Full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF)|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1435331|NCT00972244|Secondary|Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%|Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy|At Week 12|Full Analysis Set, participants with non-missing baseline and week 12 (LOCF) values|||Percentage of participants|||Number
1435332|NCT00972244|Secondary|Adjusted Mean Change in Fasting Plasma Glucose|Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
1435333|NCT00972244|Primary|Adjusted Mean Change in HbA1c Levels|The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available.|Baseline to Week 12|Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values|||percent||95% Confidence Interval|Least Squares Mean
1435334|NCT00972205|Secondary|Number of Participants Who Had an Overall Response|"Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR)-disappearance of all target lesions, Partial response (PR)-at least a 30% decrease in the sum of the longest diameter(LD)of target lesions, stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.~See the Protocol Link module for further details about the RECIST Criteria."|Baseline to progression||||participants with response|||Number
1435335|NCT00972205|Secondary|Percent Inhibition of Rhodamine Efflux From CD56+Cells Post Treatment|Rhodamine 123 was added to whole blood obtained before and after CBT-1. The blood was incubated, layered on lymphocyte separation medium and centrifuged. Peripheral blood mononuclear cells(PBMCs)were isolated, washed and incubated in rhodamine-free medium with or without valspodar. Cells were washed and incubated in phycoerythrin-labeled anti-CD56 antibody or negative control antibody. Rhodamine 123 fluorescence was assessed in CD56+cells with or without valspodar and a 60 min efflux period,continuing the cells without or with valspodar to generate Efflux and PSC/Efflux histograms.|Rhodamine efflux was performed on blood drawn prior to CBT-1 ingestion and after 6 days of dosing.|Rhodamine 123 fluorescence was assessed in CD56+cells after a 30 min loading period with or without exogenously added valspodar and a 60 min efflux period followed, continuing the cells with or without exogenous valspodar to generate Efflux and PSC/Efflux histograms. Percent decrease in difference between these histograms is reported.|||Percent inhibition of rhodamine efflux||Full Range|Mean
1435336|NCT00972205|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months||||Participants|||Number
1435337|NCT00972205|Primary|Percent Increase in Sestamibi Retention in the Liver as a Measure of P-glycoprotein Inhibition|An area under the concentration curve (AUC) was calculated for 99mTc counts over the liver, lungs, and heart. An equation was applied to determine the increase in sestamibi in the liver: [(AUCpost - AUC baseline)/(AUC baseline)] x 100.|sestamibi scanning was performed on day 0 and day 6, allowing scans to be performed pre and post CBT-1 administration|As planned imaging data from 10 pts were analyzed.|||percent increase sestamibi retention||Full Range|Median
1435338|NCT00972153|Secondary|Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter|Airborne particulate was measured using a particle analyzer (LASAIR II 310B). The analyzer sampled continuously during surgery at a rate of 28.3 L/min and recorded data at one-minute intervals. The samples were collected through a length of sterile PVC tubing with the end placed adjacent to the CFU sample tubing, within 5 cm of the surgical incision. Particles of various diameters were obtained; particles of size >10 micrometer had the strongest correlation to the presence of CFUs at the incision site.|Ten minute intervals throughout surgery||||>10 micrometer particles / cubic meter||Full Range|Median
1435367|NCT00971789|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events|47 months||||Participants|||Number
1435339|NCT00972153|Primary|Surgery Site CFU Density|"Colony forming unit counts were collected from the air within 5 cm of the surgical wound using a bioaerosol slit sampling device. Air was drawn through a sterile PVC tubing located at the incision and impacted upon media (TSA 5% sheep's blood) plates located in the sampling device. The plates were exchanged every 10 minutes throughout the procedure. Values are presented as CFU/cubic meter."|Ten minute intervals throughout surgery|Airborne CFU densities were obtained in ten-minute intervals throughout each procedure. Average surgery duration was 69 minutes in the control and sham groups; 66 minutes in the experiment group. A total of 208 density readings were obtained.|||CFU/cubic meter||Full Range|Median
1435340|NCT00972088|Primary|Prevalence of Inflammation as Diagnosed by Capsule Endoscopy|The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.|up to 7 days|per protocol|||participants|||Number
1435341|NCT00972023|Secondary|Toxicity||Within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
1435342|NCT00972023|Secondary|Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
1435343|NCT00972023|Secondary|Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
1435344|NCT00972023|Primary|Tumor Proliferation (Percentage of Ki-67 Positive Cells)||Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.|Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.||||||
1435345|NCT00971997|Secondary|Number of Hypoglycemia Episodes Participants Experienced at Any Time From Baseline Through Week 48|A hypoglycemic episode was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or participants had a blood glucose level below 50 mg/dL regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.|||number of hypoglycemic episodes|||Number
1435346|NCT00971997|Secondary|Percentage of Participants Developing Hypoglycemia at Any Time From Baseline Through Week 48|Results are reported as the percentage of participants experiencing hypoglycemia, which was considered any hypoglycemic event in which participants themselves recognized hypoglycemia-related signs and symptoms, or they had a blood glucose level below 50 milligram/deciliter (mg/dL) regardless of signs, symptoms or the relationship to treatment.|Baseline through Week 48|Participants received at least one dose of the study drug.|||percentage of participants|||Number
1435347|NCT00971997|Secondary|Total Daily Dose of Insulin at Baseline, Week 16, Week 32 and Week 48||Baseline and Weeks 16, 32 and 48|Participants who completed treatment through Week 48.|||units of insulin/day||Standard Deviation|Mean
1435348|NCT00971997|Secondary|Change From Baseline in Body Weight at Week 48 Endpoint||Baseline, Week 48|Participants who completed treatment through Week 48, and had both baseline and post-baseline value.|||kilogram (kg)||Standard Deviation|Mean
1435349|NCT00971997|Secondary|Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||mg/dL||Standard Deviation|Mean
1435350|NCT00971997|Secondary|Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint|C-peptide is a protein that is produced in the body along with insulin.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1435351|NCT00971997|Secondary|Change From Baseline in Blood Glucose Profile at Week 48 Endpoint|Time course of changes in blood glucose was determined by 7-point self-monitoring of blood glucose (SMBG) during the day (before breakfast, lunch, and dinner, 2 hours after the start of each meal, and at bedtime).|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||mg/dL||Standard Deviation|Mean
1435352|NCT00971997|Secondary|Change From Baseline in Fasting Glucose at Week 48 Endpoint||Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1435353|NCT00971997|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 48|Participants received at least one dose of the study drug, and had both baseline and post-baseline values.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1435354|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Level Below 6.5% and Below 7.0% by Regimen at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. 6.5% and 7.0% HbA1c are the Japan Diabetes Society (JDS) values, and are equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c values of 6.9% and 7.4%, respectively.|Week 48|Participants completed treatment through Week 48.|||percentage of participants||95% Confidence Interval|Number
1435355|NCT00971997|Secondary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 7.0% at Week 16, 32 and 48 Endpoints|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 7.0% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 7.4%.|Week 16 and Week 32 and Week 48|Participants received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
1437772|NCT00951496|Secondary|Overall Survival|Estimate the median duration of overall survival in months.|Up to 10 years|Intention-to-treat: All enrolled patients|||Months||95% Confidence Interval|Median
1435357|NCT00971997|Primary|Percentage of Participants Achieving Hemoglobin A1c (HbA1c) Below 6.5% at Week 48 Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The 6.5% HbA1c is the Japan Diabetes Society (JDS) value, and is equivalent to the National Glycohemoglobin Standardization Program (NGSP) HbA1c value of 6.9%.|Week 48|Participants received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
1435358|NCT00971932|Secondary|Time to Treatment Failure|Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.|Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|"ITT population included all participants who received at least one dose of the study medication. Here number of participants analyzed N is signifying those participants for whom trial treatment failed."|||months||95% Confidence Interval|Median
1435359|NCT00971932|Secondary|Overall Survival (OS) Time|Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||months||95% Confidence Interval|Median
1435360|NCT00971932|Secondary|Progression-Free Survival (PFS) Time|The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.|Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||months||95% Confidence Interval|Median
1435361|NCT00971932|Secondary|Duration of Response|Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).|Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011|Subgroup of participants from the study population with a best overall response (CR or PR).|||months||95% Confidence Interval|Median
1435362|NCT00971932|Secondary|Disease Control Rate|Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (>=50 percent decrease in sum of the products of diameters [SOPD] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease [SD] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
1435363|NCT00971932|Secondary|Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.|Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011|ITT population included all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
1435364|NCT00971932|Primary|Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria|Percentage of participants experiencing a complete response [CR] (complete disappearance of measurable and evaluable disease without new lesions) or partial response [PR] (greater than or equal to 50 percent decrease in the sum of the products of diameters [SOPD] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).|Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011|Intention-to-treat (ITT) population included all participants who received at least one dose of the study medication.|||percentage of participants||95% Confidence Interval|Number
1435365|NCT00971841|Secondary|Number of Participants With Complete Response to Tumor|Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).|Every 7 weeks Day 1 to 4 years|Only one participant enrolled so results are for one participant.|||participants|||Number
1435366|NCT00971841|Primary|Number of Adverse Events (AEs) Per Participant|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.|Weekly Day 1 to 4 years|Only one participant enrolled in the study so all results represent one participant.|||adverse events|||Number
1435368|NCT00971789|Primary|Biochemical Changes in Benign and Malignant Tumor Tissues as Assessed by Immunohistochemistry.|A biochemical change is defined as a decrease in certain protein levels (e.g. P-AKT (phosphorylated AKT), total S6, P-S6, and P-4E-BP1) important in cell growth. These are measured by collecting tissue samples which stained and protein levels are measured under the microscope. Scoring will be based on distribution and intensity of staining. Distribution will be scored as 0 (0%), 1 (1% to 50%), and 2 (51% to 100%) to indicate the percentage of positive cells of interest in a single core. The intensity of the signal will be scored as 1 (weak), 2 (moderate), and 3 (strong). The distribution score and intensity score will be summed into a total score (TS).|Baseline, day 14, and day 56|No patient underwent biopsy after the study treatment, so no such tissue analysis was done.||||||
1435369|NCT00971750|Primary|Polyps on Transabdominal and Laparoscopic Ultrasound|Number of patients with polyps.|6 years||||participants|||Number
1435370|NCT00971750|Secondary|Common Bile Duct (CBD) Diameter Measured by Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Mean CBD diameter.|transabdominal measurements will be done within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively||||millimeters||Standard Deviation|Mean
1435371|NCT00971750|Primary|Cholelithiasis on Transabdominal Ultrasound Versus Laparoscopic Ultrasound.|Number of patients with cholelithiasis.|transabdominal measurements within 30 days prior to surgery; laparoscopic ultrasound measurements are completed intraoperatively||||participants|||Number
1435372|NCT00971633|Primary|Maximum Plasma Concentration (Cmax) of Ondansetron||24 hours post dose|All study participants (N=12)|||nM||Standard Deviation|Least Squares Mean
1435373|NCT00971633|Primary|Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose|All study participants (N=12)|||nM*hr||Standard Deviation|Least Squares Mean
1435374|NCT00971620|Secondary|Worst Pain Severity|Pain severity was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)). This outcome was based on a single 0-10 question on the BPI.|Week 0 vs. week 4||||Score||Full Range|Median
1435375|NCT00971620|Secondary|Percentage of Patients With a Change in Post-Ice Visual Analog Score (VAS) Between Week 0 and Week 4|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 = worse pain.|Week 0 vs. week 4||||percentage of patients|||Number
1435376|NCT00971620|Secondary|Percentage of Patients With a Change in Pre-Ice Visual Analog Score (VAS) Between Week 0 and Week 4|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale of 0-10. 10 = worse pain.|Week 0 vs. week 4||||percentage of patients|||Number
1435377|NCT00971620|Secondary|Percentage of Patients With a Change in Average Pain Score|Average pain was determined from a 0-10 scale question on the Brief Pain Inventory (BPI). 10 denotes worse pain.|Week 0 score vs. week 4 score||||percentage of patients|||Number
1435378|NCT00971620|Secondary|Immunohistochemical Staining of Cutaneous Leiomyomas for C-fos Before (i.e., Week 0) and 12 Weeks After Botulinum Toxin Administration|c-fos, a marker of neuronal activation after pain stimulation, was scored as 0 (none), 1 (scattered), 2 (<66% of tumor cells), or 3 (≥66% of tumor cells).|Week 0 vs. week 12||||Score||Full Range|Median
1435379|NCT00971620|Secondary|Immunohistochemical Staining of Cutaneous Leiomyomas for Acetylcholinesterase (AchE) Before (i.e.,Week 0) and 12 Weeks After Botulinum Toxin Administration|AchE staining was scored as 0 (none), 1 (rare), 2 (scattered), or 3 (focal or greater).|Week 0 vs. week 12||||Score||Full Range|Median
1435380|NCT00971620|Secondary|Change in Post-Ice Provocation Visual Analog Score (VAS) Between Week 12 and Week 24|The VAS is a commonly used validated tool for assessment of pain. The 10-cm VAS was used to assess current patient pain/discomfort before and after application of ice to study lesions. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Scale is 0-10. 10 denotes worse pain than 0.|Between week 12 and 24||||Score||Full Range|Median
1435381|NCT00971620|Secondary|Specific Skin Pain-Related Question on the Dermatology Life Quality Index|"The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Participants response to the question Over the last week, how itchy, sore, painful or stinging has your skin been? was assessed by the Dermatology Life Quality Index. This outcome refers to a single specific question on the DLQI, so the range for this outcome is 0-3. Lower values in the DLQI indicate less impairment (or greater improvement) in life quality from the skin disease."|Week 0 vs. week 4||||Units on a scale||Full Range|Median
1435382|NCT00971620|Secondary|Comparison of Change in Skin Related Quality of Life by Total Dermatology Life Quality Index (DLQI) at Week 0 vs. Week 4|The DLQI is a 10-question quality of life survey which has been extensively validated and frequently used in dermatologic disorders such as atopic dermatitis, acne, and psoriasis. Score is 0-30 based on 10 questions. The higher the score, the more quality of life is impaired.|Week 0 vs. week 4||||Units on a scale||Full Range|Median
1435383|NCT00971620|Secondary|Visual Analog Scale (VAS) of Patient Perceived Pain at Leiomyoma Site Prior to Ice Provocation at Week 0 vs. Week 4|The VAS is a commonly used validated tool for assessment of pain. For this measure, a 10-cm VAS was used to assess current patient pain/discomfort before application of ice to study lesions at week 0 and week 4. A clinically meaningful change in chronic pain intensity using the VAS has been determined as a reduction of 2 points or 30%. Range is 0-10; 0 is no pain and 10 is worst possible pain.|Week 0 vs. week 4||||Score||Full Range|Median
1435384|NCT00971620|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|37 months||||participants|||Number
1437068|NCT00957801|Primary|Serum Estradiol Measured on Treatment Day 8 (Post Study)|Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.|treatment day 8||||pg/mL||Standard Deviation|Mean
1435385|NCT00971620|Primary|Median Change in Average Pain Between Two Arms|Change in average pain was assessed by the Brief Pain Inventory (BPI). The BPI is a validated pain assessment tool that assesses severity of pain, location of pain, impact of pain on daily functions, pain medications, and amount of pain relief in the past 24 hours or past week (e.g. scale of 0-10 (worst pain)).|Between weeks 0 and week 4||||Score||Full Range|Median
1435386|NCT00971620|Primary|Change in Worst Lesional Pain in the Past Week Based on Brief Pain Inventory|Change in worst lesional pain in the past week based on Brief Pain Inventory (BPI) from Week 0 to Week 4 in treated patients versus controls. The BPI uses an arbitrary units on a 0-10 scale. For the purposes of the statistical calculation, a difference of 1 standard deviation between groups at baseline vs. week 4 was considered significant. Any BPI value above zero (no pain) is abnormal. The mean change indicates mean change in pain score.|Between week 0 and week 4||||units on a scale||Standard Error|Mean
1435387|NCT00971425|Secondary|Number of Subjects With AEs of Specific Interest|Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1435388|NCT00971425|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0-364)|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1435389|NCT00971425|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination"|During 21 days (Day 0-20) after each vaccination|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1435390|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix|Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)|During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix|The analysis was performed on the Total Vaccinated cohort on subjects with available results.|||subjects|||Number
1435391|NCT00971425|Secondary|Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix|Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).|During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix|The analysis was performed on the Total Vaccinated cohort on subjects with available results|||subjects|||Number
1435392|NCT00971425|Secondary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.~Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
1435393|NCT00971425|Secondary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"For the definition of seroconversion factor, please refer to the primary outcome measure.~Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||fold increase||95% Confidence Interval|Mean
1435394|NCT00971425|Secondary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.~Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63)."|At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
1435395|NCT00971425|Secondary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"The cut-off was a titer of 1:10 and this titer was considered as seropositivity.~Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
1435520|NCT00969540|Secondary|Sleep Variables (Sleep Efficiency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep efficiency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Percentage of time asleep||Standard Deviation|Mean
1435396|NCT00971425|Secondary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains|"Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.~Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63."|Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||titer||95% Confidence Interval|Geometric Mean
1435397|NCT00971425|Primary|Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
1435398|NCT00971425|Primary|Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain|"Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0).~The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||fold increase||95% Confidence Interval|Mean
1435399|NCT00971425|Primary|Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
1435400|NCT00971425|Primary|Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain|"The Pandemrix vaccine strain was A/Cal/7/09.~The cut-off was a titer of 1:10 and this titer was considered as seropositivity."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||subjects|||Number
1435401|NCT00971425|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain|"Titers were expressed as GMTs.~The Pandemrix vaccine strain was A/Cal/7/09."|At Day 42|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.|||titer||95% Confidence Interval|Geometric Mean
1435402|NCT00971295|Secondary|AUC0-∞ - Area Under the Plasma Concentration From Time Zero to Infinity|area under the plasma metformin concentration from time zero to infinity|3 weeks||||ng*h/mL||Standard Deviation|Mean
1435403|NCT00971295|Secondary|Tmax - Time of Occurrence of Cmax|time of occurrence of maximum observed plasma metformin concentration|3 weeks||||hours||Standard Deviation|Mean
1435404|NCT00971295|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum Observed Plasma Metformin Concentration|3 weeks||||ng/mL||Standard Deviation|Mean
1435405|NCT00971282|Primary|Pruritus|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
1435406|NCT00971282|Primary|Stinging/Burning|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
1435407|NCT00971282|Primary|Dryness|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
1435408|NCT00971282|Primary|Scaling|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
1435409|NCT00971282|Primary|Erythema Rating Scale|score from 0 (none) to 3 (severe)|at 4 weeks|safety population (APT)|||units on a scale||Standard Error|Mean
1435410|NCT00971243|Secondary|Adverse Events, Laboratory Tests, Vital Signs, Etc.||Weeks 24, 52|||||||
1435411|NCT00971243|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24|Change in FPG from baseline to Week 24 or LOCF was assessed with an ANCOVA approach similar to that of the primary efficacy endpoint.|Baseline and Week 24|LOCF was implemented in the ITT population analysis to replace missing values for all those subjects who did not present a FPG value at Week 24.|||mg/dL||Standard Error|Least Squares Mean
1435412|NCT00971243|Primary|Change in HbA1c From Baseline to Week 24|The change of HbA1c from baseline to Week 24 or a last observation carried forward (LOCF), was assessed with an analysis of covariance (ANCOVA) model, with the centre and treatment effect as factors and the baseline HbA1c as a covariate.|Baseline and Week 24|LOCF was implemented in the Intention-to-Treat (ITT) population analysis to replace missing values for all those subjects who did not present an HbA1c value at Week 24.|||percentage of HbA1c||Standard Error|Least Squares Mean
1435413|NCT00971204|Primary|Freedom From Recurrence of Atrial Fibrillation|Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.|12 months|Primary Effectiveness Endpoint participants. Of the 86 enrolled and treated participants, 84 were evaluable for the effectiveness endpoint.|||successful participants|||Number
1435414|NCT00971048|Secondary|Moist Wound Environment as Per the Bates-Jensen Wound Assessment Tool (BWAT)|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound exudate type and amount) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|At every visit: Day 8, Day 15, Day 22, Day 29||||BWAT-m Exudate Score||Standard Error|Least Squares Mean
1435415|NCT00971048|Secondary|Pain Assessed by a 100-mm VAS Scale.|100-mm VAS scale was used to evaluate pain, with 1 being healthy tissue (no pain) up to 100 (wound degeneration and severe pain)|At every visit: Day 8, Day 15, Day 22, Day 29|Intent-to-Treat|||VAS Pain Scores||Standard Error|Least Squares Mean
1435416|NCT00971048|Secondary|Number of Participants With Wound Closure by Day 22.||22 days||||Subjects|||Number
1435521|NCT00969540|Secondary|Sleep Variables (Nocturnal Awakenings) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Number of nocturnal awakenings with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Awakenings||Standard Deviation|Mean
1435417|NCT00971048|Primary|Adequate Management of the Wound Assessed by a Left Movement (Improvement) in the Modified Bates Jensen Wound Assessment Tool.|Modified Bates-Jensen Wound Assessment (BWAT-m) Scores for those characteristics measured (wound size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, periwound color and edema, granulation tissue, and epithelialization) were each graded on a 5-point scale, with 1 being the best and 5 being the worst.|22 - 29 days|Intent-to-Treat|||units on a scale||Standard Error|Least Squares Mean
1435418|NCT00970944|Primary|Disability Rating Scale: Functional Status|"Measure of function after traumatic brain injury (TBI) intended to measure function from coma to community. Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability)."|Randomization and weekly for 6 weeks. The primary study endpoint was week 4 and drug washout was week 6.|Analyses were conducted according to the intention-to-treat principle. 184 subjects were randomized and included for analysis. Since missing data were infrequent and unrelated to the study outcome, imputation methods were not undertaken.|||units on a scale||Standard Deviation|Mean
1435419|NCT00970944|Secondary|JFK Coma Recovery Scale-Revised: Neurobehavioral Status|"Measure of neurobehavioral function and clinical change for individuals with severe alterations of consciousness.~Minimum score= 0; Maximum score= 23 (Higher scores are indicative of a higher-level of neurobehavioral function)."|Week 4 (primary endpoint); Week 6 (post-washout)|Analyses were conducted according to the ITT principle so that all 184 patients randomized were included for analysis. Imputation techniques were not undertaken since missing data were infrequent and unrelated to study outcome.|||units on a scale||Standard Deviation|Mean
1435420|NCT00970853|Secondary|Teacher Rating Form (TRF), Total Problems|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435421|NCT00970853|Secondary|Teacher Rating Form (TRF), Externalizing|"The TRF is the companion to the CBCL and is completed by the child's teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Best score is 30; worst score is 80."|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435422|NCT00970853|Secondary|Teacher Rating Form (TRF), Internalizing|The TRF is the companion to the CBCL and is completed by the child’s teacher. The TRF measures a broad range of behavioral, emotional, and social functioning. The TRF asks teachers to rate problem behaviors and questions about receipt of educational services. Respondents are asked to rate 112 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child”, based on the past two months. The raw scores from the 112 items are then compared with scores from age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. value is 80; best value is 30.|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435423|NCT00970853|Secondary|Child Behavior Checklist (CBCL),Total Problems|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. Worst score is 80; best score is 30."|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435424|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Externalizing|"The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for not true of the child, 1 for somewhat or sometimes true of the child, and 2 for very true or often true of the child, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are derived with a mean of 50 and a standard deviation of 10. The worst possible score is 80 and the best possible score is 30."|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435425|NCT00970853|Secondary|Child Behavior Checklist (CBCL), Internalizing|The CBCL is part of The Achenbach System of Empirically Based Assessment (ASEBA)that measures a broad range of behavioral, emotional, and social behaviors. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for “not true of the child,” 1 for “somewhat or sometimes true of the child,” and 2 for “very true or often true of the child”, based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435426|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Math|The WJR-III, Ach, Broad Math measures math academic achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Math was selected because its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families. The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435427|NCT00970853|Secondary|Woodcock-Johnson Academic Ability Test, 3rd Edition (WJR-III, Ach), Broad Reading|The WJR-III, Ach, Broad Reading measures reading achievement in children and offers a recent standardization sample and updated item content. The WJR-III, Ach, Broad Reading was selected because it includes indices of reading and a recent standardization sample that includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years from study entry||||units on a scale||Standard Deviation|Mean
1435428|NCT00970853|Primary|Woodcock-Johnson Cognitive Ability Test, 3rd Edition (WJR-III, Cog)|The WJR-III, Cog measures intelligence and cognition in children and offers a recent standardization sample and updated item content. The WJR-III, Cog was selected because it includes verbal, nonverbal, and language scales and its recent standardization sample includes an appropriate proportion of children from ethnic minority, limited parent education, and Northeastern U.S. regional families.The mean test score is 100, with a standard deviation of 15. The test yields scores from 55 (worst score) to 145 (best score).|8 years post original enrollment in study|All were included.|||units on a scale||Standard Deviation|Mean
1435429|NCT00970814|Primary|The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Study Weeks 5-14||||percentage of heavy drinking days||Standard Error|Least Squares Mean
1435430|NCT00970814|Secondary|The Number of Drinks Per Drinking Day Study Weeks 5-14.|based on self report|Study Weeks 5-14||||drinks per day||Standard Error|Least Squares Mean
1435431|NCT00970814|Primary|The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.|A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.|Weeks 5-14||||percentage of subjects|||Number
1435432|NCT00970736|Secondary|Area of Submental Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation.|2 weeks|This data was not analyzed because the study, funding, and PIs VA affiliation ended prior to any data analyses.||||||
1435433|NCT00970736|Secondary|Motor Map Center of Gravity|Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).|2 weeks|This data was not analyzed because the study and funding, as well as the PIs VA affiliation, ended prior to doing any analyses.||||||
1435434|NCT00970736|Primary|Mean Motor Evoked Potential Amplitude for Submental Cortical Representation|Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.|2 weeks|This data was not analyzed because the study funding, as well as PIs VA affiliation, ended prior to any data analyses.||||||
1435435|NCT00970684|Secondary|Best Response|The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)|1 year|One patient was unevaluable for response due to missing baseline tumor measurement.|||participants|||Number
1435436|NCT00970684|Secondary|Median Time to Progression|Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.|1 year|Intent to treat|||months||95% Confidence Interval|Median
1435437|NCT00970684|Primary|Progression Free Survival(PFS)|PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm). If no deaths occur prior to progression, this measure will be the same as the median time to progression.|1 year|Intent to treat|||months||95% Confidence Interval|Median
1435438|NCT00970632|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|PVR was the amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliter (mL)||Standard Deviation|Median
1435439|NCT00970632|Secondary|Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks|V-comp (volume of urine voided) was measured in milliliters (mL) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and V-comp was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliter (mL)||Standard Deviation|Median
1435440|NCT00970632|Secondary|Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks|Q-mean (mean urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was >=125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliters per second (mL/sec)||Standard Deviation|Median
1435522|NCT00969540|Secondary|Sleep Variables (Total Sleep) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Total sleep time with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Minutes||Standard Deviation|Mean
1435441|NCT00970632|Secondary|Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks|Q-max (peak urine flow rate) was measured in milliliters per second (mL/sec) using a standard calibrated flowmeter. At each visit, a uroflowmetry assessment was considered valid and data were included in the analyses only if the prevoid total bladder volume (assessed by ultrasound) was ≥150 to ≤550 mL and the voided volume (V-comp) was ≥125 mL.|Baseline, 12 weeks|The analysis population included all randomized participants who started study medication, and had non-missing data at baseline and at endpoint (last non-missing post-baseline value).|||milliliters per second (mL/sec)||Standard Deviation|Median
1435442|NCT00970632|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks|IIEF measured self-reported EF over the past 4 weeks. Scores ranged from 0 (low or no EF)-5 (high EF) on 6 questions (1-5, 15 of the IIEF). Total EF Domain scores ranged from 1-30. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all randomized sexually active participants with erectile dysfunction who started study medication, and had baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435443|NCT00970632|Secondary|Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall|The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. The overall TSS-BPH score was converted to a percentage of the maximum value possible (percent ranged from 0-100) with lower scores indicating greater satisfaction.|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline measurement.|||units on a scale||Standard Deviation|Median
1435444|NCT00970632|Secondary|Clinician Global Impression of Improvement (CGI-I) at 12 Weeks|"The CGI-I was an investigator-rated instrument that measured improvement or worsening of the participant’s symptoms based on a 7-point scale. A score of 1=participant felt symptoms were “very much better”; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt “no change” in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were “very much worse”."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.|||participants|||Number
1435445|NCT00970632|Secondary|Patient Global Impression of Improvement (PGI-I) at 12 Weeks|"The PGI-I was a participant-rated instrument that measured the improvement or worsening of the participant’s symptoms based on a 7-point scale at Week 12. A score of 1=participant felt symptoms were “very much better”; score of 2=participant felt symptoms were much better; score of 3=participant felt symptoms were a little better; score of 4=participant felt “no change” in symptoms; score of 5=participant felt symptoms were a little worse; score of 6=participant felt symptoms were much worse; score of 7=participant felt symptoms were “very much worse”."|12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data.|||participants|||Number
1435446|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435447|NCT00970632|Secondary|Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks|BII was a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores ranged from 0-13; higher scores represented increased perceived impact of BPH-lower urinary tract symptoms (LUTS) on overall health. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435448|NCT00970632|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week|The mIPSS Total Score covered a time period of 1 week and was obtained by combining scores of responses to Component Questions 1-7. Each question was scored from 0-5 for an mIPSS range of 0-35 points; higher numerical scores represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 1 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 1 week|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435449|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks|IPSS QoL assessed QoL by urinary symptoms, with scores ranging from 0 (delighted)-6 (terrible). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1450611|NCT00847665|Secondary|Workload of Nurses|Time actually spent to manual repositioning by nurses team, in minutes/day|icu length of stay||||minutes per day||Inter-Quartile Range|Median
1435450|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks|The IPSS nocturia question (Component Question 7) measured nocturia (need to urinate at night) over the past 4 weeks. Scores ranged from 0 (no episodes of nocturia)-5 (5 or more episodes of nocturia). Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435451|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.|IPSS voiding (obstructive) subscore was the sum of Component Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms)-5 (frequent obstructive symptoms); therefore, the 4 questions of the obstructive score ranged from 0-20. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435452|NCT00970632|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks|IPSS storage (irritative) subscore was the sum of Component Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); therefore, the 3 questions of the irritative subscore ranged from 0 to 15. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435453|NCT00970632|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 4 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435454|NCT00970632|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was obtained by combining the scores of the responses to Component Questions 1-7. Each question was scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represented greater severity of symptoms. Least Squares (LS) Mean of change from baseline to endpoint (Week 12 or last post-baseline value carried forward) was from an analysis of covariance (ANCOVA) and adjusted for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction, and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population included all participants who were randomized, started study medication, and had non-missing data at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1435455|NCT00970606|Primary|Hospital Mortality to Day 28 or if Mortality is Not Different Between Groups, Time to Achieve Resolution of Respiratory Failure (e.g., Time to Unassisted Breathing in Survivors (Including Patient's Never Requiring Mechanical Ventilation).|No outcome analyses were run as the sample size was not of sufficient size for a comparison with only 7 of >2000 participants planned/anticipated actually enrolled.|28 days|Only 7 participants were enrolled in this study designed for >2000. No formal anlaysis of outcomes was performed as tne n was too small to show any differences||||||
1435456|NCT00970502|Secondary|Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity|At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.|1 year||||percentage of participants|||Number
1435457|NCT00970502|Secondary|Locoregional Progression|Patients with locoregional and/or distant progression|20 months||||participants|||Number
1435458|NCT00970502|Secondary|Clinical Response|Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|20 months||||Participants|||Count of Participants
1435459|NCT00970502|Primary|Toxicity|Number of participants with acute and late toxicity|30 DAYS|Erlotinib and celecoxib were administered orally|||participants|||Number
1435460|NCT00970489|Secondary|Other Endpoints|"Number of days in the ICU, of telemetry monitoring, and of total hospital stay.~Non-AF arrhythmias of at least 30 sec duration, including non-AF-SVT, ventricular tachycardia (VT), and ventricular flutter (VF), assessed and adjudicated by the Events Committee.~MACE: Combined total mortality, myocardial infarction, and stroke.~Bleeding, assessed by (a) chest tube output in the 24 hour period following surgery and (b) total number of packed red blood cell (RBC) transfusions from enrollment to end of treatment (hospital discharge or post-op day 10).~Significant adverse events: Discontinuation of study treatment, at the discretion of the treating physicians, for suspected significant allergic reaction, severe gastrointestinal intolerance, significant bleeding, or other side effects requiring discontinuation.~Thirty-day mortality assessed~One-year mortality assessed"|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
1450612|NCT00847665|Secondary|ICU Mortality|ICU mortality (number of death in ICU)|ICU length of stay (an average of 28 days)||||participants|||Number
1435461|NCT00970489|Secondary|Other Arrhythmias|"The first 3 suspected episodes of atrial fibrillation or flutter of at least 30 sec duration following randomization were documented, including the following information:~Printed or digital rhythm strip and/or 12-lead ECG.~Recording of time of onset and time of cessation.~Additional documentation of temporally associated signs of symptoms, such as new or worsening chest pain, shortness of breath, or lightheadedness; drop in blood pressure requiring escalation of fluid or pressor treatment; or need for electrical or pharmacologic cardioversion.~The first suspected episode of each of other supraventricular or unknown narrow-complex tachycardia of at least 30 sec duration following randomization was also documented."|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
1435462|NCT00970489|Secondary|Post-op Af|Secondary AF endpoints included post-op AF that was sustained (>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality.|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
1435463|NCT00970489|Primary|Any First Post-op Atrial Fibrillation or Flutter (AF)|Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).|up to 10 days post-surgery or discharge, whichever sooner||||Participants|||Number
1435464|NCT00970359|Secondary|Change From Baseline in Serum Thyroglobulin Levels After Treatment With 131I|Will perform a Wilcoxon signed rank test for paired samples to compare the serum thyroglobulin level before and after 131I treatment in the subset of patients treated with 131I following AZD6244.|At 2 months and 6 months after Radioiodine administration|Only patients treated with Radioiodine.|||percentage of reduction of levels||Full Range|Mean
1435465|NCT00970359|Primary|Tumor Response Defined as Either a Complete Response or Partial Response|as defined by the RECIST v1.1 criteria Descriptive statistics will be used to summarize the data.|6 months|Only patients treated with radioiodine.|||participants|||Number
1435466|NCT00970359|Primary|Number of Patients Whose Tumor(s) Acquire an Increased Propensity for Iodine Uptake as Detected on Iodine-124 Positron Emission Tomography Scan||2 years||||participants|||Number
1435467|NCT00970320|Secondary|Change in Manometry Measurements|manometric measurements of pelvic floor muscle strength and anal sphincter length during voluntary pelvic floor muscle contraction|12 to 24 months postpartum|||||||
1435468|NCT00970320|Secondary|Change in Pelvic Floor Muscle Function Test as Measured on the ICS Scale|Digital palpation and grading of voluntary pelvic floor muscle contraction (1=absent, 2=weak, 3=normal, 4=strong).|12 to 24 months postpartum|||||||
1435469|NCT00970320|Secondary|Fecal Incontinence of Life (FIQL) Scale|Change in health-related quality of Life as measured on the fecal incontinence quality of life scale (FIQL). There is no total scale, only four sub scales ranging from 4 (complete continence, no impact on QoL) to 1 (complete incontinence, severe impact on QoL) Data from the postpartum period has not and will not be analysed due to low numbers.|0 to 24 months postpartum|||||||
1435470|NCT00970320|Secondary|Change in Urinary Incontinence as Measured on ICI-Q UI SF|"International Consultation of Incontinence Questionnaire, short form (ICI-Q SF) ranges from 0 (Complete continence) to 21 (Complete incontinence) and measures the frequency of UI, amount of leakage and impact on quality of life.~Data have not been analysed."|0 to 24 months postpartum|||||||
1435471|NCT00970320|Primary|Change in Anal Incontinence as Measured on the St. Mark's Score|Survey and interview using the questionnaire St. Mark's incontinence score ranging from 0 (no incontinence) -24 (complete incontinence) points for measuring anal incontinence (AI). The A total of 1069 women responded to the questionnaires at 6 months postpartum and 1031 at 12 months postpartum. Discrepancies in the number of included and analysed participants in the PFME trials are related to the number of women who did not attend the follow-up appointments as described in the published paper.|0 to 24 months postpartum||||units on a scale||Standard Deviation|Mean
1435472|NCT00970307|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the entire study period (from Month 0 to Month 3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435473|NCT00970307|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1435474|NCT00970307|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.|During the 8-day (Days 0-7) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.|||Participants|||Count of Participants
1435475|NCT00970307|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.|During the 8-day (Days 0-7) post-vaccination period after any vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and had the symptom sheets filled in.|||Participants|||Count of Participants
1435476|NCT00970307|Secondary|Anti-PD Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1435477|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-protein D (Anti-PD)|A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435478|NCT00970307|Secondary|Anti-pneumo Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||µg/mL||95% Confidence Interval|Geometric Mean
1435479|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes|A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435480|NCT00970307|Secondary|Anti-polio Types 1, 2 and 3 Antibody Titers|Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Titers||95% Confidence Interval|Geometric Mean
1435481|NCT00970307|Secondary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435482|NCT00970307|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1435483|NCT00970307|Secondary|Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435484|NCT00970307|Secondary|Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN|A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435485|NCT00970307|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1435486|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435487|NCT00970307|Secondary|Anti-D and Anti-T Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
1435488|NCT00970307|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)|A seroprotected subject was defined as a subject with anti-D or anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435489|NCT00970307|Secondary|Anti-PSC Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||µg/mL||95% Confidence Interval|Geometric Mean
1435490|NCT00970307|Secondary|Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)|A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435491|NCT00970307|Secondary|Antibody Titers Against rSBA-MenC|The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Titers||95% Confidence Interval|Geometric Mean
1435492|NCT00970307|Secondary|Anti-PRP Antibody Concentrations|Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.|At Months 0 and 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||µg/mL||95% Confidence Interval|Geometric Mean
1435493|NCT00970307|Primary|Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)|A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435494|NCT00970307|Primary|Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)|A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results were available for antibodies against at least one study vaccine antigen component at the post-primary vaccination blood-sampling time point.|||Participants|||Count of Participants
1435495|NCT00970294|Secondary|Glycemic Control|HbA1c measure|Baseline and at 10 weeks (change score)||||percentage of glycosolated hemoglobin||Standard Deviation|Mean
1435496|NCT00970294|Secondary|Aerobic Fitness|peak VO2 as measured with a graded maximal exercise test on a cycle ergometer|Baseline and at 10 weeks (change score)||||mL/kg/m||Standard Deviation|Mean
1435497|NCT00970294|Primary|Recruitment, Retention, Adherence|% of enrolled subjects who completed the trial|10 weeks||||percentage of participants|||Number
1435498|NCT00970281|Secondary|Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection|Assesses extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms; 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). Total points of 8 items are defined as DIEPSS total (0 to 32 points). Items for assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by points given to corresponding items (item 6, item 7, and item 8, respectively).|Up to 24 hours after the first IM injection|Participants with an abnormal value at post-baseline, last observation carried forward (LOCF).|||percentage of participants|||Number
1435499|NCT00970281|Secondary|Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection|The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable). Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.|up to 24 hours after the first IM injection|Participants having a post-baseline measure, last observation carried forward (LOCF).|||percentage of participants|||Number
1435523|NCT00969540|Secondary|Sleep Variables (Nighttime Wake-time) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Nighttime wake-time after sleep onset with placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Minutes||Standard Deviation|Mean
1435666|NCT00968201|Secondary|Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients who reported serious drug-related LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435500|NCT00970281|Secondary|Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Up to 2 hours after the first (IM) injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).|||percentage of participants|||Number
1435501|NCT00970281|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 24 hours after first IM injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1435502|NCT00970281|Secondary|Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection|Full analysis set (FAS): All randomized participants administered at least 1 intramuscular (IM) injection of the investigational product with at least 1 observation after the first IM injection, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1435503|NCT00970281|Primary|Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection|Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.|Baseline, up to 2 hours after first IM injection|Participants with a baseline and a value at the time, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1435504|NCT00970268|Secondary|Change From Baseline in Peak FEV1|Change From Baseline (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).|52 weeks||||L||Standard Error|Least Squares Mean
1435505|NCT00970268|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)|Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1|Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks|From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population|||L||Standard Error|Least Squares Mean
1435506|NCT00970216|Primary|HBV-DNA < 300 Copies/mL in 48 Weeks||48 weeks||||participants|||Number
1435507|NCT00969878|Secondary|•The Immunogenicity of TA-CD;|Peak antibody levels after five vaccinations with TA-CD, which occurred at week 16.|During the 18 weeks study period.||||micrograms/ml||95% Confidence Interval|Mean
1435508|NCT00969878|Primary|Cocaine Abstinence During Weeks 9 to 16 Inclusive|Number of patients having at least 2 weeks of cocaine-free urines between weeks 9-16 after vaccination with five doses of TA-CD 400 µg compared to placebo|Over 8 weeks ( Study Weeks 9 to 16 inclusive)||||participants|||Number
1435509|NCT00969709|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate functional impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe for all measured symptoms)|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment(Intent to Treat [ITT] Population).|||units on a scale||Standard Error|Mean
1435510|NCT00969709|Primary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|"The MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity for all measured symptoms)."|From Baseline to Week 8|A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment (Intent to Treat [ITT] Population).|||Units on a scale||Standard Error|Least Squares Mean
1435524|NCT00969540|Primary|Optically Modified Polyethylene Terephthalate Fiber Mattress Cover (OMPETFMC) Improves Sleep Quality in Patients With Lower Back Pain as Measured by Clinical Global Impression (CGI).|"The primary outcomes are the change in mean daily Clinical Global Impressions (pain and sleep) in placebo mattress compared to active mattress cover (assessed daily for 14 days per intervention).~The daily scores range from 1 (very much improved) to 7 (very much worse)."|14 days|The sponsor determined the size of the study.|||units on a scale||Standard Deviation|Mean
1435525|NCT00969501|Primary|Number of Participants With a Reduction in Pain by the Scores.|Greater than 50 percent reduction in pain scores from baseline.|6 months|￼|||participants|||Number
1435511|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Depressive Symptoms, as Measured by Hamilton Depression Rating Scale-17 (HAMD-17) Items|The HAMD-17 instrument consists of 17 items used to assess the severity of depression and its improvement during the course of therapy. This instrument is completed by the clinician based on his or her assessment of the participant. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). The total score is the sum of the scores from HAMD-17 Items 1 through 17 and ranges from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate greater symptom severity.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMD-17 measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
1435512|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A) Version: Informant Scores (BRIEF-A:Informant Scores)|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75-225 total score). Behavioral regulation subscale measures participant’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A Informant scores measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
1435513|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)|The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the overall severity of the participant’s ADHD symptoms in relation to the clinician’s total experience with ADHD participants. CGI-ADHD-S measures severity of the participant's overall severity of ADHD symptoms: 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CGI-ADHD-S measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
1435514|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in Comorbid, Anxiety Symptoms, as Measured by Hamilton Anxiety Rating Scale-14 (HAMA-14) Items|The HAMA-14 instrument consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. This instrument is completed by the clinician based on his or her assessment of the participant. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score is the sum of the 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate greater anxiety.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline HAMA-14 measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
1435515|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale: 1 (behavior never observed) to 3 (behavior often observed). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75- 225 total score). Behavioral regulation subscale measures participant’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Higher subscale ratings indicate greater perceived impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline BRIEF-A self report measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
1435516|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life (AAQoL)-29 Scores|AAQoL is a 29 items participant completed questionnaire rated on a 5-point Likert scale from 1 (Not at all/ Never) to 5 (Extremely/Very Often). AAQoL total (all 29 items) and 4 subscale scores: Life Productivity (11 items); Psychological Health (6 items); Life Outlook (7 items); Relationships (5 items). Total score is computed by (1) reversing scores for all items except the 7 items in the Life Outlook subscale; (2) transforming scores to 0-100 scale (1=0; 2=25; 3=50; 4=75; 5=100); (3) summing item scores and dividing by the item count. Higher total scores indicate better quality of life.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline AAQoL measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
1435517|NCT00969618|Secondary|Mean Change From Baseline to 48 Weeks Endpoint in the Conners' Adult Attention-Deficit Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version-Japanese (CAARS-Inv:SV-J)|CAARS-Inv:SV-J is a 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and attention deficit hyperactivity disorder (ADHD) Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention subscales (scores range from 0-27) and hyperactivity/impulsivity subscales (scores range from 0-27) with a total score range of 0-54. The ADHD Index scores range from 0-36. Higher scores indicate greater impairment.|Baseline, 48 weeks|All participants who received at least one dose of study drug, and had a baseline and at least one post-baseline CAARS measurement. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Deviation|Mean
1435518|NCT00969618|Primary|Number of Participants With Adverse Events Leading to Discontinuation||Baseline through 48 weeks|All participants who received at least one dose of study drug.|||participant|||Number
1435519|NCT00969540|Secondary|Sleep Variables (Sleep Latency) Measured With Actigraphy in Patients With Lower Back Pain.|Secondary outcome: Sleep latency in placebo mattress cover compared to active mattress cover.|Assessed daily for 14 days per intervention.|The sponsor determined the number of participants.|||Minutes||Standard Deviation|Mean
1435756|NCT00967226|Secondary|Allergy/Immunology Adverse Events|Number of allergy/immunology AE per study arm|enrollment through study closeout or study withdrawal up to 9 months||||Adverse Events|||Number
1435526|NCT00969436|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.|From the first study dose up to study end (Month 0 to Month 7.5 approximately)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1435527|NCT00969436|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Event|An unsolicited Adverse Event (AE) covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within 43-day (Days 0-42) after the first and second vaccination dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1435528|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Rash|Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination|During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
1435529|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
1435530|NCT00969436|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
1435531|NCT00969436|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
1435532|NCT00969436|Secondary|Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses|Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).|At 42 – 56 days after the first (at Week 6) and second (at Week 30) vaccination dose|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
1435533|NCT00969436|Secondary|Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies|Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.|Approximately 42 to 56 days after the first vaccine dose at week 6|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.|||Participants|||Count of Participants
1435534|NCT00969436|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies|Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42 – 56 days after the second vaccination dose at week 30|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.|||Participants|||Count of Participants
1435535|NCT00969280|Secondary|General Assessment||visit 11|||||||
1435536|NCT00969280|Secondary|Medication Quantification Scale (MQS)||every visit|||||||
1435537|NCT00969280|Secondary|Tear Film Break-up Time : BUT||Visit 1, 10|||||||
1435538|NCT00969280|Secondary|Schirmer 1 Test||visit 1,10|||||||
1435539|NCT00969280|Secondary|Visual Analogue Scale of Self Symptoms||every visit|||||||
1435555|NCT00968981|Primary|Area Under the Curve From Time Zero to 24 Hour (AUC0-24) for Total and Unbound GDC-0449|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). Below the limit of quantitation (BLQ) values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified timepoint in each group.|||mcM*hour||Standard Deviation|Mean
1435540|NCT00969280|Primary|Ocular Surface Disease Index : OSDI|The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals “none of the time” and 4 equals “all of the time”. OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.|Visit 11 (after 3 weeks from baseline)|Statistical analyses were conducted on an intention-to-treat basis (ITT analysis, significance p<0.05). According to the last observation carried forward method (LOCF method), the last observed missing values were used to complete missing values from drop-out participants.|||Scores on the OSDI score|Participants|Standard Deviation|Mean
1435541|NCT00969228|Secondary|Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)||From Dose 1 up to 1 month after Dose 2.|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1435542|NCT00969228|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (2-3 months).|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1435543|NCT00969228|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 – Day 30) follow-up period after each vaccine dose|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1435544|NCT00969228|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.|During the 8-day (Day 0 – Day 7) follow-up period after each vaccine dose.|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1435545|NCT00969228|Secondary|Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations|Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||units per milliliter (U/mL)||95% Confidence Interval|Geometric Mean
1435546|NCT00969228|Primary|Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A|Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.|One month after the second vaccine dose|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available results.|||subjects|||Number
1435547|NCT00969150|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8||||units on a scale||Standard Error|Least Squares Mean
1435548|NCT00969150|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.~Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity)."|From Baseline to Week 8|Of the 357 patients who received at least 1 dose of double-blind treatment (Safety Population), 355 patients had at least 1 postbaseline MADRS assessment (Intent to Treat [ITT] Population).|||units on a scale||Standard Error|Least Squares Mean
1435549|NCT00969124|Secondary|Time Spent During Withdrawal Phase and Total Procedure|Time in minutes for withdrawal phase of procedure and for total procedure|During the colonoscopy procedure (up to 1 hour, average 25 minutes)||||minutes||Standard Deviation|Mean
1435550|NCT00969124|Primary|Detection Rates for All Polyps|All polyps detected with the colonoscope alone vs. with the Retroscope|During the colonoscopy procedure (up to 1 hour, average 25 minutes)||||All polyps|||Number
1435551|NCT00969124|Primary|Detection Rates for Adenomas|Adenomas detected with the colonoscope alone vs. with the Retroscope|During the colonoscopy procedure (up to 1 hour, average 25 minutes)||||Adenomas|||Number
1435552|NCT00968981|Primary|Time to Achieve Maximum Observed Plasma Concentration (Tmax) After a Single Dose of GDC-0449||0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1|PK Evaluable Population.|||hours||Full Range|Median
1435553|NCT00968981|Secondary|Duration of Response (DR)|DR during first line therapy is defined as the time from when response (complete response [CR] or partial response [PR]) was first documented to first documented disease progression or death (whichever occurs first) during first line therapy. This was only be calculated for participants who achieved a best overall response of CR or PR. Participants who did not progress or die after they had a confirmed response were censored at the date of their last tumor measurement or last follow up for progression of disease during first line therapy. CR: disappearance of all target lesions (TLs) with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters. PR: at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum diameters. DR was not calculated as only 1 responding participant reached their response at the last scheduled response assessment, hence follow-up data are not available.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|||||||
1435554|NCT00968981|Primary|Area Under the Curve From Time Zero to the Last Measured Concentration (AUClast) for Total and Unbound GDC-0449|AUC values were calculated using the linear trapezoidal method when the concentrations were rising and using the logarithmic trapezoidal method when the concentrations were declining (linear up/log down rule in WinNonlin). BLQ values at pre-dose were considered as zero for PK analysis.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. n = number of participants with data available at specified time point in each group.|||mcM*hour||Standard Deviation|Mean
1435556|NCT00968981|Primary|Maximum Plasma Concentration (Cmax) of Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in ng/mL units and converted to mcM units using the molecular weight (421.30 g/mol) prior to PK analysis.|0, 1, 2, 4, 6, 24, 48, 72 hours on Day 1, 15 and 57 post-dose|PK Evaluable Population. 'n' signifies number of participants with data available at specified timepoint in each group.|||mcM||Standard Deviation|Mean
1435557|NCT00968981|Primary|Plasma Concentration at Steady State (Css) for Total and Unbound GDC−0449|Plasma GDC-0449 concentrations were reported in nanogram per milliliter (ng/mL) units and converted to micromolar (mcM) units using the molecular weight (421.30 grams per mole [g/mol]) prior to PK analysis. Css was calculated for Days 28 to 56.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. N = participants with baseline and post baseline data available for measurement of Css at steady state.|||mcM||Standard Deviation|Mean
1435558|NCT00968981|Primary|Ratio of Total and Unbound Trough GDC-0449 Concentration Between Day 57 to Day 15|Ratio = trough concentration on Day 57 divided by trough concentration on Day 15. If the ratio of total and unbound trough GDC-0449 concentration between Day 57 to Day 15 is less than 1, then it indicates reduction in total and unbound trough GDC-0449 concentration between Day 15 to Day 57.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. N = participants who completed Day 57 of the study were included in this analysis.|||ratio||Full Range|Mean
1435559|NCT00968981|Primary|Number of Participants With Greater Than (>) 50 Percent (%) Decrease in Trough Concentration at Steady State (Css, Trough)|Percent change = ([trough concentration on Day 15 minus trough concentration on Day 57] divided by trough concentration on Day 15) multiplied by 100.|Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|PK Evaluable Population. Here number of participants analyzed (N) = participants with baseline and at least 1 post baseline assessment for this outcome.|||participants|||Number
1435560|NCT00968981|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady-State for Both Total and Unbound GDC-0449||Predose and 1, 2, 4, 6, 24, 48, and 72 on Days 1, 29, 50, and 54 and predose on Days 8, 10, 15, 22, 33, 36, 43, and 57|The PK Evaluable Population. Number of participants analyzed (N) is equal to (=) participants with baseline and at least one post-baseline assessment for this outcome; n = participants evaluable at specified time-points.|||hours||Full Range|Median
1435561|NCT00968981|Secondary|Progression-Free Survival (PFS) Time|PFS defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by the investigator review of tumor assessments using RECIST, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population.|||months||95% Confidence Interval|Median
1435562|NCT00968981|Secondary|Percentage of Participants With a Response by Best Overall Response (BOR)|BOR was defined as the best overall response observed during the treatment period according to RECIST. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Screening Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population; only participants with measurable disease at baseline were included in the analysis.|||percentage of participants|||Number
1435563|NCT00968981|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression (assessed by Response Evaluation Criteria in Solid Tumors [RECIST]) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of one or more new lesions and/or unequivocal progression of existing non target lesions.|Screening, Day 57, and every 8 weeks thereafter up to 52 weeks|Efficacy Evaluable Population: all participants who had measurable disease at baseline and either had at least one follow-up tumor assessment or discontinued the study due to disease progression.|||percentage of participants|||Number
1435564|NCT00968890|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1435565|NCT00968890|Secondary|Number of Subjects With Adverse Events of Specific Interest|Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.|From Day 0 to Day 364|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1435566|NCT00968890|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|From Day 0 to Day 83|The analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1435567|NCT00968890|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).|Within 7 days (Day 0-Day 6) after each vaccination|Analysis was performed on the Total Vaccinated cohort.|||subjects|||Number
1435568|NCT00968890|Secondary|Number of Subjects With Titers Equal to or Above Titer 1:10|"The cut-off 1:10 was considered as seropositivity.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
1435569|NCT00968890|Secondary|Geometric Mean Fold Rise (GMFR)|The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||ratio||95% Confidence Interval|Geometric Mean
1435570|NCT00968890|Secondary|Number of Seroprotected Subjects|A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
1435571|NCT00968890|Secondary|Number of Seroconverted Subjects|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
1435572|NCT00968890|Secondary|Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains|"Titers are expressed as GMTs.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|Days 0, 21, 42, 182, 364|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1435573|NCT00968890|Primary|Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix|"The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||ratio||95% Confidence Interval|Geometric Mean
1435574|NCT00968890|Primary|Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
1435575|NCT00968890|Primary|Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix|"A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.~The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08."|21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.|||subjects|||Number
1435576|NCT00968864|Secondary|Device Performance: Dose of CD34+ Cells and CD3+ Cells Given|"For mismatched related donors, the target cell dose after processing is >/= 20 x 10^6 CD34+ cells/kg patient body weight, but >/= 8 x 10^6 is acceptable.~For unrelated donors the target cell dose after processing is >/= 10 x 10^6 CD34+ cells/kg patient body weight, but >/= 4 x 10^6 is acceptable.~The target T cell dose is </= 3 x 10^4 CD3+ cells/ kg."|Length of the trial (5 years)||||cells/ kg||Full Range|Mean
1435577|NCT00968864|Secondary|Overall Survival||2 years|Subjects at least 2 years after transplant are evaluable for 2 year overall survival.|||Participants|||Count of Participants
1435578|NCT00968864|Secondary|Number of Participants With Transplant-related Toxicities||1 year||||Participants|||Count of Participants
1435579|NCT00968864|Secondary|Number of Participants With Transplant-related Mortality|Transplant-related mortality includes death due to regimen-related toxicity or GVHD (all causes other than disease relapse). Those who died due to disease relapse are not included in the analyzed population for that time point.|2 year|Those who died due to disease relapse are not included in the analyzed population for that time point.|||Participants|||Count of Participants
1435580|NCT00968864|Secondary|Number of Participants With Post-transplant Leukemia Relapse||5 years|Of the 43 recipients in the mismatched related donor cohort, 24 of those had leukemia. No recipients in the matched unrelated donor cohort had leukemia.|||Participants|||Count of Participants
1435581|NCT00968864|Secondary|Number of Participants With EBV-related Post Transplant Lymphoproliferative Disorder (PTLD)||5 years||||Participants|||Count of Participants
1435582|NCT00968864|Secondary|Number of Participants With Post-transplant Infections||1 year||||Participants|||Count of Participants
1435583|NCT00968864|Secondary|Number of Participants With Engraftment and Time to Engraftment|Engraftment was measured as time to absolute neutrophil count >500|Within 28 days after stem cell transplant|There were 2 cases of primary graft failure in the mismatched related donor cohort; both achieved engraftment following a second transplant.|||days||Full Range|Mean
1435585|NCT00968838|Primary|Number of Participants Alive at Day 30|Participant survival measured over the 30 days subsequent to the first granulocyte transfusion. Collecting complete blood counts (CBCs) pre and post transfusion allows determination of whether the duration of neutrophil replacement differs between the two study groups (comparing unradiated white blood cells to radiated white blood cell infusion).|30 Days||||Participants|||Number
1435586|NCT00968812|Secondary|Change in HbA1c From Baseline to Week 104|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Baseline, Week 104|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug).|||Percent||Standard Error|Least Squares Mean
1435587|NCT00968812|Secondary|Percent Change in Body Weight From Baseline to Week 52|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
1435588|NCT00968812|Secondary|Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52|The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percentage of patients|||Number
1435589|NCT00968812|Primary|Change in HbA1c From Baseline to Week 52|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change.|Day 1 (Baseline) and Week 52|Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
1435590|NCT00968799|Secondary|Pharmacokinetics|data not analysed due to poor accrual|intraoperative and 1 week after surgery|||||||
1435591|NCT00968799|Secondary|Overall Survival||5 years||||months||Full Range|Median
1435592|NCT00968799|Secondary|Surgical Complications|any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)|6 weeks post operation||||participants|||Number
1435593|NCT00968799|Secondary|Nephrotoxicity|glomerular filtration rate (GFR)|6 weeks post operation||||participants|||Number
1435594|NCT00968799|Primary|Fitness for Systemic Chemotherapy|"Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial.~If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit.~If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit."|3 months post operation||||participants|||Number
1435595|NCT00968708|Secondary|Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)|Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.|From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).|Full analysis set|||percentage of participants|||Number
1435596|NCT00968708|Primary|Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)|Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.|From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).|Full analysis set (all randomized participants)|||percentage of participants|||Number
1435597|NCT00968669|Secondary|Accumulation Ratio of Trough Concentrations of MEDI-528|Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81) and received at least one dose of investigational product.|||Ratio||Standard Deviation|Mean
1435598|NCT00968669|Secondary|Half Life of MEDI-528|Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.|Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).|||Days||Standard Deviation|Mean
1435599|NCT00968669|Secondary|Day 169 Steady State Trough Concentration of MEDI-528|Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169.|Day 169|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).|||Microgram per milliliter||Standard Deviation|Mean
1435600|NCT00968669|Secondary|First Dose Trough Concentration of MEDI-528|First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose.|Day 15|All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively).|||Microgram per milliliter||Standard Deviation|Mean
1435601|NCT00968669|Secondary|Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528|Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo|Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo (n=82) group and received at least one dose of investigational product.|||Participants|||Number
1435602|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 176 (n=62, 58, 64, and 60 for placebo, 30, 100, and 300 mg MEDI-528, respectively).|||Participants|||Number
1435603|NCT00968669|Secondary|Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.|Day 85|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 85 (n=69, 63, 76, and 68 for placebo, 30, 100, and 300 mg MEDI-528, respectively).|||Participants|||Number
1435604|NCT00968669|Secondary|Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176|Day 176|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 176 (n=67, 75, or 73 for 30, 100, or 300 mg MEDI-528, respectively, and n=69 for placebo).|||Liters||Standard Deviation|Mean
1435605|NCT00968669|Secondary|Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 92 (n=62, 73, or 72 for 30, 100, or 300 mg MEDI-528, respectively, and n=67 for placebo).|||Liters||Standard Deviation|Mean
1435606|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 176.|||Day||95% Confidence Interval|Median
1435607|NCT00968669|Secondary|Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis)|Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Days 1 - 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 92.|||Day||95% Confidence Interval|Median
1435629|NCT00968539|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 83)|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1435608|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.|||Participants|||Number
1435609|NCT00968669|Secondary|Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis)|Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 92.|||Participants|||Number
1435610|NCT00968669|Secondary|Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis)|Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 176|All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176.|||Scores on a scale||Standard Deviation|Mean
1435611|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Day||95% Confidence Interval|Median
1435612|NCT00968669|Secondary|Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Day||95% Confidence Interval|Median
1435613|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Participants|||Number
1435665|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Extension|Patients who were discontinued due to LAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435614|NCT00968669|Secondary|Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis)|The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Participants|||Number
1435615|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 176|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Exacerbations per participant year||95% Confidence Interval|Number
1435616|NCT00968669|Secondary|Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis)|Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject’s asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.|Days 1 - 92|All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo)|||Exacerbations per participant year||95% Confidence Interval|Number
1435617|NCT00968669|Primary|Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis)|Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.|Day 92|All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups.|||Scores on a scale||Standard Deviation|Mean
1435618|NCT00968617|Secondary|Number of Participants Who Were Responders|Responder was defined as a participant achieving (pre-transfusion) an increase from baseline hemoglobin of greater than or equal to 1 g/dL and a hemoglobin concentration of greater than or equal to 11 g/dL.|Each week up to 12 weeks||||Participants|||Number
1435619|NCT00968617|Secondary|Change From Baseline in Hemoglobin Level||Weeks 1-3, 5-10, and Week 12||||g/dL||Standard Deviation|Mean
1435620|NCT00968617|Secondary|Hemoglobin Concentration After Treatment With MK2578||Weeks 1-10 and Week 12||||g/dL||Standard Deviation|Mean
1435621|NCT00968617|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||16 Weeks||||Participants|||Number
1435622|NCT00968617|Primary|Number of Participants With Hypertension, Seizure, and Pure Red Cell Aplasia||16 Weeks||||Participants|||Number
1435623|NCT00968617|Primary|Number of of Participants With Composite Events of Injection Site Reactions||16 Weeks||||Participants|||Number
1435624|NCT00968617|Primary|Number of Participants With Composite Events of Transfusion-related Adverse Experiences||16 Weeks||||Participants|||Number
1435625|NCT00968617|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction and Cerebrovascular Accident, Serious Events of Unstable Angina, Transient Ischemic Attack, Arrythmia and Congestive Heart Failure, Peripheral Thrombo-embolic Events||16 Weeks||||Participants|||Number
1435626|NCT00968617|Primary|Change From Baseline in Hemoglobin Level at Week 4||4 weeks||||g/dL||Standard Deviation|Mean
1435627|NCT00968539|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1435628|NCT00968539|Secondary|Number of Subjects With Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 364)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1435630|NCT00968539|Secondary|Number of Days With Solicited General Symptoms|The number of days with any solicited general symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Temperature.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1435631|NCT00968539|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Headache, Joint pain at other location, Muscle aches, Shivering, Sweating and Fever [defined as axillary temperature equal to or above ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
1435632|NCT00968539|Secondary|Number of Days With Solicited Local Symptoms|The number of days with any solicited local symptoms reported during the solicited post-vaccination period. There were no subjects from GSK2340269A Group who reported Redness or Swelling.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with the symptom sheet filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
1435633|NCT00968539|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.|||Participants|||Count of Participants
1435634|NCT00968539|Secondary|Number of Seroconverted Subjects for Serum Neutralizing Antibodies Against Flu A/Neth/602/09|"Seroconversion was defined as:~For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Neth/602/09."|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435635|NCT00968539|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Neth/602/09. The reference seropositivity cut-off value was ≥ 1:8.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1435636|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.~The flu strain assessed was Flu A/CAL/7/09."|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Fold increase||95% Confidence Interval|Geometric Mean
1435637|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.~The flu strain assessed was Flu A/CAL/7/09."|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Fold increase||95% Confidence Interval|Geometric Mean
1435638|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.~The flu strain assessed was Flu A/CAL/7/09."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1435639|NCT00968539|Secondary|Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"Seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.~The flu strain assessed was Flu A/CAL/7/09."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1435640|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1435641|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
1435642|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435643|NCT00968539|Secondary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Days 0 and 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435644|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion was defined as:~For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.~The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09)."|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1435645|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion was defined as:~For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.~The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09)."|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
1435646|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion was defined as:~For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.~The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09)."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435647|NCT00968539|Secondary|Number of Seroconverted Subjects for HI Antibodies|"Seroconversion was defined as:~For initially seronegative subjects (antibody titer < 1:10 prior to vaccination), antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.~The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09)."|At Day 21|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435648|NCT00968539|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Titers||95% Confidence Interval|Geometric Mean
1435649|NCT00968539|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
1435650|NCT00968539|Secondary|Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Titers||95% Confidence Interval|Geometric Mean
1435651|NCT00968539|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|"Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.~The Flu strain assessed was Flu A/CAL/09."|At Day 364|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects who met all eligibility criteria and for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1435652|NCT00968539|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|"Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.~The Flu strain assessed was Flu A/CAL/7/09."|At Day 182|The analysis was performed on the ATP cohort for persistence at Month 6, which included all evaluable subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 6.|||Participants|||Count of Participants
1435757|NCT00967226|Secondary|Pulmonary/Respiratory Adverse Events|Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm|enrollment through study close out or withdrawal, up to 9 months||||Adverse Events|||Number
1435653|NCT00968539|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|"Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination.~The Flu strain assessed was Flu A/CAL/7/09."|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435654|NCT00968539|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease|"GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.~The flu strain assessed was Flu A/CAL/7/09."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Fold increase||95% Confidence Interval|Geometric Mean
1435655|NCT00968539|Primary|Number of Seroprotected Subjects for HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer ≥ 1:40. The flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435656|NCT00968539|Primary|Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies|"Seroconversion was defined as:~For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.~The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09)."|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 vaccine doses and for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken up to 21 days after the second vaccine dose.|||Participants|||Count of Participants
1435657|NCT00968253|Secondary|Participant Responses by Daily Dose Level Assignment (RAD001 5 mg, 10 mg and MTD 5 mg)|Response defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl. Partial remission (PR): Peripheral blood count recovery as for CR, with decrease in marrow blasts by > 50% from pretreatment values with no more than 25% leukemia/lymphoma cells in the marrow. Nonresponder, Other: All other responses will be considered failures.|Up to 20 cycles of study drugs (21 day cycles) or till disease progression||||participants|||Number
1435658|NCT00968253|Primary|Overall Response Rate (OR) Where OR = CR + CRp + CRi|Number of participants out of total treated who experienced a complete response response according to RECIST criteria either (CR + CRp) CR Without Platelet Recovery. Response (CR + CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x10^9/L, platelet count > 100 x10^9/L, and blasts < 5% in a normocellular or hypercellular marrow. Complete remission without platelet recovery (CRp): Peripheral blood and marrow parameters as for CR, but with platelet count > 20 x 10^9/L and < 100 x 10^9/L in the absence of platelet transfusions. CR with incomplete blood count recovery (CRi): Same as CR but platelets ≤ 100,000/mcl and/or neutrophils ≤ 1,000/mcl.|8 courses of treatment, up to 24 weeks||||percentage of participants|||Number
1435659|NCT00968253|Primary|Maximum Tolerated Dose [MTD] Determination by Number of Participants With Dose Limiting Toxicity (DLT)|"The Maximum tolerated dose (MTD) was the highest dose level at which fewer than 2 of 6 patients developed a dose limiting toxicity (DLT) in the first two cycles of therapy. A 3 by 3 design was used for dose escalation in the phase I portion of the study.~A dose-limiting toxic effect (DLT) was defined as a clinically significant adverse event or abnormal laboratory value directly attributable to everolimus and assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, occurring during the first or second cycle of therapy, that met any of the following criteria: CTCAE version 3.0 grade 3 increased AST or ALT for 7 days, CTCAE grade 4 increased AST or ALT of any duration, or any other clinically significant CTCAE grade 3 or 4 toxic effect. Electrolyte abnormalities (changes in glucose, chemistries, liver enzymes, pancreatic enzymes) correctable by optimal therapy and without clinical impact were not considered DLTs."|Following first two dose cycles (21 days/each), up to 42 days||||Participants|||Count of Participants
1435660|NCT00968227|Secondary|Change in Oxygen Extraction Fraction in Regions With Low Baseline Delivery.|Change in oxygen extraction fraction after transfusion of 1 unit of RBC in regions with low baseline delivery (DO2 < 4.5 ml/100g/min.|1 hour||||fraction||Standard Deviation|Mean
1435661|NCT00968227|Primary|Change in Oxygen Delivery in Vulnerable Brain Regions|Change in oxygen delivery after transfusion in brain regions with low baseline delivery.|1 hour||||ml/100g/min||Standard Deviation|Mean
1435662|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension|Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435663|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious LAEs - Extension|Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435664|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension|Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435667|NCT00968201|Secondary|Number of Patients With Serious LAEs - Extension|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1435668|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|up to 2.8 years|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435669|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435670|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension|Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435671|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Extension|Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435672|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension|Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435673|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Extension|Patients who were discontinued due to CAEs up to 2.8 years of treatment|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435674|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension|"Patients who reported serious drug-related CAEs up to 2.8 years of~treatment"|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435675|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Extension|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435676|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Extension|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435677|NCT00968201|Secondary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|up to 2.8 years|All patients who took study medication were included in the analysis.|||Participants|||Number
1435678|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study|Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435679|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to LAEs - Base Study|Patients who were discontinued due to LAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435680|NCT00968201|Secondary|Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435681|NCT00968201|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435682|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study|Patients who were discontinued due to serious CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
1435683|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study|Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
1435684|NCT00968201|Secondary|Number of Patients Who Were Discontinued Due to CAEs - Base Study|Patients who were discontinued due to CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
1435685|NCT00968201|Secondary|Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study|Patients who reported serious drug-related CAEs during 12 weeks of treatment|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
1435758|NCT00967226|Secondary|Growth and Development Adverse Events|Number of Growth and Development AEs in each study arm|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
1435686|NCT00968201|Secondary|Number of Patients With Serious CAEs Reported by Patients - Base Study|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks of treatment|"All patients who took study medication were included in the analysis.~A serious CAE (study drug overdose) prior to randomization in the Placebo group is not included in this number"|||Participants|||Number
1435687|NCT00968201|Secondary|Number of Patients With Drug-related CAEs Reported by Patients - Base Study|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|12 weeks of treatment|"All patients who took study medication were included in the analysis.~Drug relationship for 1 patient in the Placebo group should have been listed as definitely not drug related."|||Participants|||Number
1435688|NCT00968201|Primary|Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
1435689|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435690|NCT00968149|Secondary|Number of Patients With Drug-related LAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435691|NCT00968149|Secondary|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435692|NCT00968149|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.|||Participants|||Number
1435693|NCT00968149|Secondary|Number of Patients Who Were Discontinued Due to CAEs||2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
1435694|NCT00968149|Secondary|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
1435695|NCT00968149|Secondary|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
1435696|NCT00968149|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|2 weeks|All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.|||Participants|||Number
1435697|NCT00968071|Primary|Number of Participants With Complete Response (CR)|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral anc >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.|Up to 36 weeks||||participants|||Number
1435698|NCT00968032|Primary|Number of Participants With a Successful Implantation.|The implantation of the device under investigation in a single patient is defined as successful if delivery, placement and release of the device in a stable position is successful. The value will be compared to the number of patient enrolled.|6 weeks ± 2 weeks||||participants|||Number
1435699|NCT00968019|Secondary|Stroke||Up to 12 months||||participants|||Number
1435700|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 12 months||||participants|||Number
1435701|NCT00968019|Secondary|Major Bleeding||Up to 12 months||||participants|||Number
1435702|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:~Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:~ischemic symptoms~ECG changes indicative of ischemia (ST segment elevation or depression)~Development of pathological Q waves in the ECG~Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality~Pathological findings of an acute myocardial infarction"|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
1435703|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.~Target vessel failure will be reported when:~MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is performed."|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
1435704|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
1435705|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|up to 12 months|303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)|||participants|Participants||Number
1435706|NCT00968019|Secondary|Stent Thrombosis|Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.|Up to 30 days||||participants|||Number
1435707|NCT00968019|Secondary|Stroke||Up to 30 days||||participants|||Number
1435708|NCT00968019|Secondary|Major Bleeding||Up to 30 days||||participants|||Number
1435709|NCT00968019|Secondary|Myocardial Infarction|"A positive diagnosis of myocardial infarction is made when one of the following criteria is met:~Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:~ischemic symptoms~ECG changes indicative of ischemia (ST segment elevation or depression)~Development of pathological Q waves in the ECG~Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality~Pathological findings of an acute myocardial infarction"|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
1435710|NCT00968019|Secondary|Target Vessel Failure|"Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.~Target vessel failure will be reported when:~MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is performed."|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
1435711|NCT00968019|Secondary|Clinically Driven TVR|Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
1435712|NCT00968019|Secondary|Clinically Driven TLR|Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel|Up to 30 days|309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)|||participants|Participants||Number
1435713|NCT00968019|Secondary|Procedural Success|Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)|||percentage of Procedural Success|Participants||Number
1435714|NCT00968019|Secondary|Lesion Success|Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)|||percentage of lesion Success|Participants||Number
1435715|NCT00968019|Secondary|Device Success|Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only|Peri-procedure up to discharge|318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)|||percentage of device success|Participants||Number
1435716|NCT00968019|Primary|Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))|"Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).~The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%)."|at 12 months follow-up|No formal statistical significance testing was performed. Descriptive statistics were calculated for all relevant variables (mean, standard deviation, median and ranges for the continuous variables and with frequencies and % for the discrete variables). Subjects who discontinued prematurely were included in the analysis and were not replaced.|||participants|||Number
1435717|NCT00967993|Secondary|The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug.||6 weeks|||||||
1435718|NCT00967993|Primary|The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.||4 weeks||||mg/dL||Standard Deviation|Mean
1435719|NCT00967798|Secondary|Change in Percent Predicted FEV1|The decline of lung function was assessed with forced expiratory volume (FEV1), which measures how much air is exhaled during one second of a forced exhale. Change is described as the difference in FEV1 at baseline subtracted from FEV1 at the end of treatment study visit. A protocol change during the study reduced the treatment time from 24 months to 12 months. The end of treatment study visit for participants in the early part of the study occurred at 24 months, while the end of treatment visit was a 12 months for participants enrolling later. Negative values indicate a decline in lung function over the course of the study.|Baseline, end of treatment (Month 12 or Month 24)|The participants included in this analysis are limited to those who have a FEV value for the baseline and end of treatment visits.|||percent predicted||Standard Deviation|Mean
1435786|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 0 corresponds to baseline. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 0||||units on a scale||Standard Deviation|Mean
1435720|NCT00967798|Secondary|Change in Inflammatory Cytokines|Hyperglycemia causes release of pro-inflammatory cytokines which can further compromise beta-cell function by increasing insulin resistance and by inducing beta-cell apoptosis. Inflammatory cytokines that have been shown to contribute to destruction of beta-cells include interleukin 1 beta (IL-1b), tumor necrosis factor alpha (TNFa), and interleukin 6 (IL-6).|Baseline through Month 12|Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.||||||
1435721|NCT00967798|Secondary|Change in Redox Couples Glutathione/Glutathione Disulfide and Cysteine/Cystine|Cysteine (Cys)/cystine (CySS) and glutathione (GSH)/glutathione disulfide (GSSG) redox couples are biomarkers of oxidative stress.|Baseline through Month 12|Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.||||||
1435722|NCT00967798|Secondary|Change in Beta-cell Disposition Index|Preservation of beta-cell function was to be assessed with the disposition index, which is a measurement of beta-cell function adjusted for insensitivity to insulin.|Baseline through Month 15|Samples for the serum assays were destroyed when a freezer broke over a weekend and the samples thawed.||||||
1435723|NCT00967798|Primary|Number of Participants With Conversion to Cystic Fibrosis Related Diabetes|The number of participants with conversion to cystic fibrosis related diabetes was determined.|Month 15||||Participants|||Count of Participants
1435724|NCT00967694|Primary|Change in Intraocular Pressure During Nitrous Oxide Sedation||Before, during and after administration of nitrous oxide (45 minutes total)||||mmHg (difference in IOP)||95% Confidence Interval|Mean
1435725|NCT00967668|Secondary|Change in Weight|Expected weight change from baseline to 24 months in kilograms based on linear mixed-effects model using all available data. Statistical analyses methods are the same as for the 12-month outcome.|24 months after enrollment|Includes only individuals who formally consented to participate in the second 12 months of the study.|||kilograms||95% Confidence Interval|Mean
1435726|NCT00967668|Primary|Change in Weight|Expected weight change from baseline to 12 months in kilograms based on linear mixed-effects model using all available data|12 months after enrollment||||Kilograms||95% Confidence Interval|Mean
1435727|NCT00967551|Secondary|Proportion of Children With Respiratory Infections|Number of children with respiratory infections divided by the total number of children in the group|6 months|All children enrolled|||percentage of participants|||Number
1435728|NCT00967551|Primary|Proportion of Children of Diarrhea Episodes|Number of children with diarrhea divided by the number of children in the group|6 months|All children enrolled|||percentage of participants|||Number
1435729|NCT00967486|Primary|Overall Perioperative Complications Between Selective vs. Routine Shunting.|perioperative complication included at least one of transient ischemic attack (TIA), hemorrhage, myocardial infarction [MI], or asymptomatic carotid thrombosis or congestive heart failure.|Within 30 days of enrollment||||Participants|||Number
1435730|NCT00967473|Primary|Lens Axis Misalignment|Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.|Time of surgery|All implanted subjects were included in this analysis.|||Degrees||Full Range|Mean
1435731|NCT00967473|Primary|Reduction of Cylinder|Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.|6 months after surgery on second eye|All implanted subjects were included in this analysis.|||Percent reduction of cylinder||95% Confidence Interval|Mean
1435732|NCT00967473|Primary|Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment|Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects’ experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.|Before Surgery and 180 days after second eye implant|Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention.|||Participants|||Number
1435733|NCT00967447|Secondary|Volume of Wound Drainage||From 12 To 37 Days|The trial was stopped due poor enrollment||||||
1435734|NCT00967447|Secondary|Major Extra Surgical Site Bleedings||From 12 To 37 Days|The trial was stopped due poor enrollment||||||
1435735|NCT00967447|Secondary|Major Bleeding Events (MBE)||From 12 To 37 Days|The trial was stopped due poor enrollment||||||
1435736|NCT00967447|Primary|Venous Thromboembolic Events||6 Months|The trial was stopped due poor enrollment||||||
1435737|NCT00967330|Secondary|Time to Treatment Failure||From baseline until end of study (up to 4.5 years)|Data for this outcome measure were not collected as this outcome was removed as per changes in planned analysis.|||years||Full Range|Median
1435738|NCT00967330|Secondary|Percentage of Participants Who Received Corticosteroid for Glioblastoma|Participants used corticosteroids for the glioblastoma condition. Corticosteroids included dexamethasone, methylprednisone, fortecortin, hydrocortisone, urbason, and prednisolone.|From baseline to Month 6|The safety population (SAF) was defined to include all participants who received at least 1 dose of study medication. Data were analyzed according to the treatment actually received (as treated).|||percentage of participants|||Number
1435739|NCT00967330|Secondary|Change From Baseline for Karnofsky Performance Status (KPS) Score at Baseline, Post-Baseline (up to Month 30)|KPS is an 11-level score (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100) which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Deterioration in KPS was defined as decrease of 20 or more points in KPS score.|Baseline, Post-Baseline (up to Month 30)|ITT population|||units on a scale||95% Confidence Interval|Least Squares Mean
1435740|NCT00967330|Secondary|Change From Baseline for Mini-Mental Status Examination (MMSE) at Baseline, Post-Baseline (up to Month 30)|The MMSE briefly measures orientation to time and place, immediate recall, short-term verbal memory, calculation, language and construct ability. Each area tested had a designated point value, the total score can range from 0 to 30, with a higher score indicating better function.|Baseline, Post-Baseline (up to Month 30)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1435741|NCT00967330|Secondary|Change From Baseline for EORTC QLQ Brain Neoplasm 20 (BN20) at Baseline, Post-Baseline (up to Month 30)|EORTC QLQ-BN20 consisted of 20 items assessing visual disorders, motor dysfunction, communication deficit, various disease symptoms (e.g. headaches and seizures), treatment toxicities (e.g. hair loss) and future uncertainty. All of the 20 items are rated on a 4 point Likert scale from 1=not at all, 2=a little, 3=quite a bit and 4=very much, and were linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.|Baseline, Post-Baseline (up to Month 30)|ITT population|||units on a scale||95% Confidence Interval|Least Squares Mean
1435742|NCT00967330|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30) at Baseline, Post-Baseline (up to Month 30)|The EORTC QLQ-C30 incorporates: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 ‘Not at all’ to 4 ‘Very much’; 2 questions used 7-point scale (1 ‘very poor’ to 7 ‘Excellent’). Scores were averaged and transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of functioning or a higher score for symptom scale=greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ‘’baseline’’ refers to the time of randomization to the maintenance phase.|Baseline, Post-Baseline (up to Month 30)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
1435743|NCT00967330|Secondary|Percentage of Participants With Response on FLAIR Imaging|"FLAIR lesions were determined as “stable”, “progressive” or “decreased”. FLAIR lesions was determined as “progressive” only if they were not be attributed to causes apart from tumor infiltration (sequelae of radiation therapy, demyelination, ischemia, infection, seizures, or other treatment effects). Percentage of participants are based on ITT population.~Dis.=Discontinuation."|At screening, Baseline, Month 6 and Therapy Discontinuation (Up to 4.5 years)|ITT population. Here, n = participants with at least 1 assessment during specified time-point.|||percentage of participants|||Number
1435744|NCT00967330|Secondary|Number of Participants With A Best Overall Response (BOR) of Complete Response (CR) and With A BOR of CR or Partial Response (PR)|BOR was defined as the best response observed for a participant during assessment. Number of participants who had BOR as CR and number of participants who had BOR as CR or PR were reported. Complete response was defined as disappearance of all enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, off steroids, and neurologically stable or improved. Partial response was defined as 50% reduction in size of enhancing tumor on consecutive Gd-MRI scans at least 1 month apart, steroids stable or reduced, and neurologically stable or improved.|4 week after radiotherapy (RT) (up to Week 4), >4 Week after RT (up to Week 8) and Month 6|ITT population. Data were analyzed according to the treatment randomized (as randomized). Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable of specified time-point.|||participants|||Number
1435745|NCT00967330|Secondary|Percentage of Participants Who Discontinued|Discontinuation was defined as the percentage of participants who permanently discontinued treatment in either treatment arm. Percentage of participant with individual discontinuation reason are reported. CNS: central nervous system; CTCAE: Common Terminology Criteria for Adverse Events . Other reason refers to any other reason than the specified ones.|From baseline until death (up to 4.5 years)|ITT population|||percentage of participants|||Number
1435746|NCT00967330|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. OS was estimated using Kaplan-Meier method.|From baseline until death (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).|||Months||95% Confidence Interval|Median
1435747|NCT00967330|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25% increase in size of enhancing tumor or any new tumor on Gd-MRI scans, or neurologically worse, and steroids stable or increased. PFS was estimated using Kaplan-Meier method.|From baseline to the end of the study (up to 4.5 years)|ITT population. Data were analyzed according to the treatment randomized (as randomized).|||Months||95% Confidence Interval|Median
1435748|NCT00967330|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Progression-free survival was defined as the time from randomization to objective tumor progression or death from any cause, whichever came first. Progression was defined as 25 percent (%) increase in size of enhancing tumor or any new tumor on gadolinium contrast agent magnetic resonance imaging (Gd-MRI) scans, or neurologically worse, and steroids stable or increased. Percentage of participants achieving PFS without disease progression or death was reported.|6 months|Intent-to-treat (ITT) population included participants randomized for whom it cannot be ruled out, that they took study medication at least once and where primary variable was measured at least once under study medication. Data were analyzed according to the treatment randomized (as randomized).|||percentage of participants||95% Confidence Interval|Number
1435749|NCT00967226|Secondary|Constitutional Adverse Events|Number of constitutional AEs in each study arm.|enrollment to study close out or withdrawal up to 9 months||||Adverse Events|||Number
1435750|NCT00967226|Secondary|Vascular Adverse Events|Number of Vascular AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
1435751|NCT00967226|Secondary|Metabolic or Laboratory AEs|Number of Metabolic or Laboratory AEs in each study arm.|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
1435752|NCT00967226|Secondary|Infectious Adverse Events|Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever)|enrollment to study withdrawal or close out up to 9 months||||Adverse Events|||Number
1435753|NCT00967226|Secondary|Gastrointestinal Adverse Events|Number of Gastrointestinal AEs in each arm|enrollment to study withdrawal or study close out up to 9 months||||Adverse Events|||Number
1435754|NCT00967226|Secondary|Endocrinologic Adverse Events|Number of Endocrinologic AEs (of which adrenal crisis does not overlap).|enrollment to close out or study withdrawal up to 9 months||||Adverse Events|||Number
1435755|NCT00967226|Secondary|Dermatologic Adverse Events|Number of Dermatologic Adverse Events in each study arm.|enrollment to study close out or withdrawal up to 9 months||||Adverse Events|||Number
1435759|NCT00967226|Secondary|Number of Serious Adverse Events (SAEs)|Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.|enrollment until study close out or withdrawal up to 9 months||||Serious Adverse Events|||Number
1435760|NCT00967226|Secondary|Tolerability of Medication|All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular.|enrollment until study close out or withdrawal up to 9 months|"All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. In this table Adverse Events are those exclusive of the Serious Adverse Events which are noted separately."|||Events|||Number
1435761|NCT00967226|Primary|Decrease in Size of Hemangioma (Length x Width) in Square mm|A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available.|4-5 months after initiating therapy|Data available at 4 or 5 months for only 9/11 propranolol participants and for 6/8 prednisolone participants due to missed appointments. Overall, 90% (138/154) study appointments were completed.|||mm squared||95% Confidence Interval|Mean
1435762|NCT00967044|Primary|Maximum Tolerated Dose (MTD) of Everolimus With Panobinostat|MTD of the novel combination of Everolimus + Panobinostat (LBH589) in a phase-I study in participants with relapsed lymphoma (Hodgkin and non-Hodgkin) where MTD is defined as the highest dose at which no more than 1 in 6 of the participants in the cohort experiences one or more dose limiting toxicities (DLTs) in the first 28 day treatment cycle. Thirty patients were enrolled onto four dose levels: Everolimus (mg, orally) 5, 5, 10, 10 daily or Panobinostat (mg, orally) 10, 20, 20, 30 three times per week. The MTD was established without the use of colony stimulating factor in cycle 1.|28 day treatment cycle||||mg, orally|||Number
1435763|NCT00967018|Other Pre-specified|Serum Levels of Testosterone Over Time|Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)|from baseline to week 72|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9)|||ng/mL||Full Range|Median
1435764|NCT00967018|Other Pre-specified|Serum Levels of Prostate Specific Antigen (PSA)Over Time|PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)|from baseline to 72 weeks|The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9)|||ng/mL||Full Range|Median
1435765|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Up to 22.5 months||||Participants|||Number
1435766|NCT00967018|Primary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Up to 22.5 months||||Participants|||Number
1435767|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 24||||units on a scale||Standard Deviation|Mean
1435768|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
1435769|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 6||||units on a scale||Standard Deviation|Mean
1435770|NCT00967005|Primary|Hamilton Anxiety Rating Scale Total Score|Week 0 corresponds to baseline. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.|Week 0||||units on a scale||Standard Deviation|Mean
1435771|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 24||||units on a scale||Standard Deviation|Mean
1435772|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 12||||units on a scale||Standard Deviation|Mean
1435773|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 6||||units on a scale||Standard Deviation|Mean
1435774|NCT00967005|Primary|Hamilton Depression Rating Scale Total Score|Week 0 corresponds to baseline. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.|Week 0||||units on a scale||Standard Deviation|Mean
1435775|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 24||||units on a scale||Standard Deviation|Mean
1435776|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 12||||units on a scale||Standard Deviation|Mean
1435777|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 6||||units on a scale||Standard Deviation|Mean
1435778|NCT00967005|Primary|Fagerstrom Test for Nicotine Dependence Total Score|Week 0 corresponds to baseline. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.|Week 0||||units on a scale||Standard Deviation|Mean
1435779|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 24||||units on a scale||Standard Deviation|Mean
1435780|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 12||||units on a scale||Standard Deviation|Mean
1435781|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. . Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 6||||units on a scale||Standard Deviation|Mean
1435782|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale|Week 0 corresponds to baseline. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.|Week 0||||units on a scale||Standard Deviation|Mean
1435783|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 24||||units on a scale||Standard Deviation|Mean
1435784|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 12||||units on a scale||Standard Deviation|Mean
1435785|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.|Week 6||||units on a scale||Standard Deviation|Mean
1435787|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 24||||units on a scale||Standard Deviation|Mean
1435788|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 12||||units on a scale||Standard Deviation|Mean
1435789|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 6||||units on a scale||Standard Deviation|Mean
1435790|NCT00967005|Primary|Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score|Week 0 corresponds to baseline. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.|Week 0||||units on a scale||Standard Deviation|Mean
1435791|NCT00966992|Secondary|Relationship of SUVmax and Metabolic Heterogeneity in the Primary Tumor and Evidence of Persistent/Recurrent Disease||3 months after completion of treatment and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
1435792|NCT00966992|Secondary|If Depressed and Anxious Moods Are Associated With Greater Impairment of Adaptive Immunity and Higher Levels of Angiogenesis in Peripheral Blood||At diagnosis, 6 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
1435793|NCT00966992|Secondary|Change in Biochemical Markers of Bone Turnover||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
1435794|NCT00966992|Secondary|Change in Bone Mineral Density||At the time of diagnosis and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
1435795|NCT00966992|Primary|Incidence of Disseminated Tumor Cells in Bone Marrow||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
1435796|NCT00966992|Primary|Incidence of Circulating Tumor Cells (CTCs)||At time of diagnosis, 3 months after completion of treatment, and 9 months after completion of treatment|This outcome measure could not be analyzed as there were no participants enrolled in the zometa arm and the outcome measure required comparing results from the no zometa arm to the zometa arm.||||||
1435797|NCT00966953|Primary|Plaque Index|Plaque score scale: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|8 weeks||||Units on a scale||Standard Deviation|Mean
1435798|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 6:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
1435799|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 4:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
1435800|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 2:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
1435801|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 12:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
1435802|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 10:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
1435803|NCT00966940|Secondary|Mean Intraocular Pressure (IOP) at 8:00 AM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
1435804|NCT00966940|Primary|Mean Intraocular Pressure (IOP) at 8:00 PM|Intraocular pressure was measured by Goldmann applanation tonometry.|6 weeks|This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.|||mm Hg||Standard Deviation|Mean
1441670|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||μU/μL||Standard Deviation|Mean
1435805|NCT00966875|Secondary|Percentage of Participants With Anti-LY2439821 Antibodies|Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.|Week 16, Week 64|Part A (Week 16) FAS: all randomized participants who received at least 1 dose of study drug with antibody testing performed; Part B (Week 64): All participants from Part A who entered the open-label portion of the study, part B, with baseline and at least 1 post-baseline antibody testing.|||percentage of participants|||Number
1435806|NCT00966875|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State|Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).|Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6|All randomized participants who received at least 1 dose of study drug in Part A and had estimable PK data, as well as, participants from Part A who entered the open-label portion of the study, Part B, and had estimable PK data.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
1435807|NCT00966875|Secondary|Relationship Between Exposure and Response of EULAR28||Through Week 72|Relationship between exposure and response of EULAR 28 analysis was reported in OMs 22 and 23 as percentage of participants in EULAR28 (Parts A and B), respectively. No further analyses were completed for EULAR28.||||||
1435808|NCT00966875|Secondary|Relationship Between Exposure and Response of DAS28||Through Week 72|Relationship between exposure and response of DAS28 analysis was reported in OMs 6 and 7 as change from baseline in DAS28 (Parts A and B) respectively. No further analyses were completed for DAS28.||||||
1435809|NCT00966875|Secondary|Relationship Between Exposure and Response of ACR20/50/70/N||Through Week 72|Relationship between exposure and response ACR20/50/70/N analysis was reported in OMs 8 and 9, as percentage of participants with ACR 20/50/70 Response (Parts A and B) and OMs 24 and 25 as percentage of participants with ACR-N (Parts A and B) respectively. No further analyses were completed for ACR20/50/70/N.||||||
1435810|NCT00966875|Secondary|Relationship Between Exposure and Response of Individual Components of the ACR Core Set||Through Week 72|Relationship between exposure and response in Individual Components (IC) of ACR Core Set analysis was reported in outcome measures (OMs) 10-21 as change from baseline in IC of ACR Core Sets: TJC, SJC, PAAP-VAS, PtGADA-VAS, PhGA-VAS, and CRP (Parts A and B). No further analyses were completed for individual components of ACR Core Set.||||||
1435811|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part B|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 HAQ-DI results.|||units on a scale||Standard Deviation|Mean
1435812|NCT00966875|Secondary|Change From Baseline in HAQ-DI - Part A|HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||units on a scale||Standard Deviation|Mean
1435813|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 Duration of Morning Stiffness results.|||minutes||Standard Deviation|Mean
1435814|NCT00966875|Secondary|Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A|The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||minutes||Standard Deviation|Mean
1435835|NCT00966875|Secondary|Change From Baseline in DAS28 - Part B|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 DAS28 results.|||units on a scale||Standard Deviation|Mean
1435815|NCT00966875|Secondary|Change From Baseline in FACIT Fatigue Scale - Part B|The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 FACIT results.|||units on a scale||Standard Deviation|Mean
1435816|NCT00966875|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A|The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.|Baseline, up to Week 12|Part A FAS: defined as all data from all randomized participants who received at least 1 dose of study drug LOCF.|||units on a scale||Standard Deviation|Mean
1435817|NCT00966875|Secondary|ACR-N - Part B|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR-N results.|||units on a scale||Standard Deviation|Mean
1435818|NCT00966875|Secondary|ACR-N - Part A|ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug with results at Week 12; LOCF.|||units on a scale||Standard Deviation|Mean
1435819|NCT00966875|Secondary|Percentage of Participants in EULAR28 - Part B|Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 EULAR28 results.|||percentage of participants|||Number
1435820|NCT00966875|Secondary|Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A|Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||percentage of participants|||Number
1435821|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 CRP results.|||mg/L||Standard Deviation|Mean
1435822|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A|CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mg/L||Standard Deviation|Mean
1435823|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B|"The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PhGA-VAS results.|||mm||Standard Deviation|Mean
1435824|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A|"The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity and the right end (100 mm) marked as extremely active arthritis. A negative change indicated a lessening in the severity of the participant's disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mm||Standard Deviation|Mean
1435825|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PtGADA-VAS results.|||mm||Standard Deviation|Mean
1435826|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A|"The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as no arthritis activity to the right end (100 mm) marked extremely active arthritis. A negative change indicated an improvement in the participant's assessment of disease activity."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mm||Standard Deviation|Mean
1435827|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PAAP-VAS results.|||mm||Standard Deviation|Mean
1435828|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A|"Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as no pain and the right end (100 mm) marked worst possible pain. The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain."|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||mm||Standard Deviation|Mean
1435829|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 SJC results.|||swollen joints||Standard Deviation|Mean
1435830|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A|SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||swollen joints||Standard Deviation|Mean
1435831|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 TJC results.|||tender joints||Standard Deviation|Mean
1435832|NCT00966875|Secondary|Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A|TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.|||tender joints||Standard Deviation|Mean
1435833|NCT00966875|Secondary|Percentage of Participants With of ACR20/50/70 Response - Part B|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].|Week 64|All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR20/50/70 results.|||percentage of participants|||Number
1435834|NCT00966875|Secondary|Percentage of Participants With ACR20/50/70 Response - Part A|ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1435852|NCT00966446|Primary|First Two Consecutive Sampling Periods Completed|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis|Within 2 months|These subjects sent in two consecutive swab samples starting with their first follow-up time point.|||participants|||Number
1435836|NCT00966875|Secondary|Change From Baseline in Disease Activity Score (DAS28)-Part A|DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 − CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.|Baseline, up to Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
1435837|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population|ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||log (dose) mg|||Number
1435838|NCT00966875|Secondary|Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population|DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 − CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||log (dose) mg|||Number
1435839|NCT00966875|Secondary|Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||log (dose) mg|||Number
1435840|NCT00966875|Secondary|Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population|ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were TNFα-IR.|||percentage of participants|||Number
1435841|NCT00966875|Primary|Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population|ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient’s Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician’s Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.|Week 12|Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.|||percentage of participants|||Number
1435842|NCT00966823|Secondary|Number of Participants With In Utero Lung Growth (LHR) >1.4|"Inclusion criterion for the study is LHR<0.9 (extreme pulmonary hypoplasia). Given that LHR is relatively constant during 2nd and 3rd trimester of gestation, In utero lung growth is defined as LHR>1.4 (definition of mild/moderate pulmonary hypoplasia) within 2 weeks of intervention.~Outcome measure = number of participants with LHR>1.4 at 2 weeks post-intervention"|Intervention to 2 weeks post-intervention||||Participants|||Number
1435843|NCT00966823|Secondary|Fetal Morbidity|Fetal morbidity, fetal mortality|Intervention to delivery||||Participants|||Number
1435844|NCT00966823|Secondary|Maternal Complications||Intervention to 30 days postpartum||||occurrences|||Number
1435845|NCT00966823|Secondary|Newborn Survival at 30 Days||30 days|1 of 2 enrolled participants (fetuses) survived until birth (Primary outcome). This 1 participant (infant) also survived at 30 days (secondary outcome).|||Participants|||Number
1435846|NCT00966823|Primary|Newborn Survival at Birth||Newborn period (1 day)||||Participants|||Number
1435847|NCT00966654|Secondary|Insulin Infusion Requirements||72 hours|The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with JHU IRB Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.||||||
1435848|NCT00966654|Primary|Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure||2 years|The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with Johns Hopkins University School of Medicine Institutional Review Board Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.||||||
1435849|NCT00966641|Primary|Area Under the Curve of Plasma Naproxen From 0 to t|Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.|30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.|Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations.|||min×μg/mL||Full Range|Mean
1435850|NCT00966550|Primary|IL-6 Concentrations||6 hour postprandial study|Analysis was per-protocol (tomato vs Non-tomato) and no imputations were given for any missing values; missing values treated as a missing.|||pg/mL||Standard Error|Least Squares Mean
1435851|NCT00966446|Secondary|Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization|Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.|Within 6 months|Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis, as this was necessary to determine clearance of MRSA colonization|||days||95% Confidence Interval|Median
1435856|NCT00966277|Primary|Number of Participants With Venous Thromboembolic Events (VTE)|Venous thromboembolism (VTE) defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE) through clinical assessments and radiologic studies. All patients undergo bilateral lower extremity ultrasound every 2 months while on study (total of 3 exams including pre-randomization). VTE requires imaging documentation to evaluate use of prophylactic anticoagulation in reducing the occurrence of VTE in a patient population with a known high risk of VTE.|16 weeks of treatment||||participants|||Number
1435857|NCT00966264|Secondary|Depression||baseline, 6 and 12 months, 5 and 10 years||2010-05-31|05/2010||||
1435858|NCT00966264|Primary|Costs||baseline, 6 and 12 months, 5 and 10 years||2010-05-31|05/2010||||
1435859|NCT00966264|Primary|HRQoL (Health Related Quality of Life)|HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)|baseline and 5 years|The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups|||points on a scale||95% Confidence Interval|Mean
1435860|NCT00966238|Secondary|Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers||28 days after vaccination|The immunogenicity of the vaccine was evaluated by measuring the number of subjects who demonstrate seroconversion either by developing a measurable titer following vaccination or by showing a significant increase in HAI serum antibody titers post-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1435861|NCT00966238|Primary|Number of Participants With Local and Systemic Immediate Reactogenicity Complaints||within 4 hours following vaccination|Immediate complaints were vaccination symptoms that were solicited and observed at 30 minutes (+15 minutes) and (±30 minutes) after the vaccination on Day 0.|||Participants|||Number
1435862|NCT00966186|Secondary|Insertion Time, Sealing Pressure and Complication||5 min - 4 hours|||||||
1435863|NCT00966186|Primary|Success of Insertion at First Attempt||5 minute||||participants|||Number
1435864|NCT00965848|Secondary|Number of Participants With 90-day Mortality|Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.|up to Day 90|"The cMITT included all participants who received any dose of study medication and met the clinical definition in the protocol. N” signifies those participants who were evaluated for this measure."|||Participants|||Number
1435865|NCT00965848|Secondary|Percentage of Participants With Clinical Response at Test-of-Cure (TOC)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT).|Up to Day 14 after End-of-Treatment (EOT)|"The cMITT included all participants who received any dose of study medication. “N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of Participants|||Number
1435866|NCT00965848|Secondary|Percentage of Participants With Clinical Response at End-of-Treatment (EOT)|Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up.|Up to Day 14 (EOT)|"Clinical Modified-Intent-to-Treat (cMITT) included all participants who received any dose of study medication. N signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of participants|||Number
1435867|NCT00965848|Primary|Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs|An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.|Up to 30 days after last dose of study drug|Intent-to-treat population (ITT) included all participants who received at least one dose of study medication.|||Participants|||Number
1435868|NCT00965757|Primary|Percentage of American College of Rheumatology [ACR] 20 Criteria Responders|ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)|||Percentage of Participants||95% Confidence Interval|Number
1435869|NCT00965757|Secondary|Percentage of ACR 70 Criteria Responders|ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||Percentage of Participants||95% Confidence Interval|Number
1436066|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1435870|NCT00965757|Secondary|Percentage of ACR 50 Criteria Responders|ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)|||Percentage of Participants||95% Confidence Interval|Number
1435871|NCT00965757|Secondary|Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)|The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||participants|||Number
1435872|NCT00965757|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Assessment of individual ACR core components i.e. ESR|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||mm/hr||Standard Deviation|Mean
1435873|NCT00965757|Secondary|Change From Baseline in C-reactive Protein (CRP)|Assessment of individual ACR core components i.e. CRP|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||mg/dl||Standard Deviation|Mean
1435874|NCT00965757|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||score on scale||Standard Deviation|Mean
1435875|NCT00965757|Secondary|Change From Baseline in PAP, PtGADA and PyGADA|Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0–100 mm, with higher scores indicating severe disease.|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||mm||Standard Deviation|Mean
1435876|NCT00965757|Secondary|Change From Baseline in Tender Joint Counts and Swollen Joint Counts|Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)|Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)|FAS (Double-blind), Efficacy Analysis Set (Extension)|||joint counts||Standard Deviation|Mean
1435877|NCT00965731|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|If no more than 1/6 participants presented with a DLT during Cycle 1 at the MTD, then this dose level was considered the RP2D. If >1/6 participants experienced a DLT, then the previous lower level was considered the MTD and RP2D.|Baseline up to 28 days (Cycle 1)|DLT evaluable population|||mg|||Number
1435878|NCT00965731|Other Pre-specified|Maximum Tolerated Dose (MTD) of PF-02341066 When Administered in Combination With Erlotinib (Phase 1)|MTD: the combination dose level of PF-02341066 and erlotinib in which 0/6 or 1/6 participants experienced DLT after 28 days of treatment (Cycle 1) with the next higher dose level having at least 2/3 or 2/6 participants with DLT during Cycle 1 of treatment.|Baseline up to 28 days (Cycle 1)|DLT evaluable population|||mg|||Number
1435879|NCT00965731|Secondary|Percentage of Participants With Mutations in Tumor Tissue (Phase 2)|Tumor tissue samples collected for molecular profiling were to be analyzed to assess Kirsten rat sarcoma (KRAS) mutations, mutations, amplification and expression of Epidermal Growth Factor Receptor (EGFR) and c-Met, and echinoderm microtubule-associated protein-like 4-anaplastic large cell receptor kinase (EML4-ALK) fusion in tumors.|Screening|Not analyzed due to phase 2 study termination||||||
1435880|NCT00965731|Secondary|Plasma Concentration of Erlotinib (Phase 2)|Plasma concentration of erlotinib when administered as a single agent during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 hours (pre-dose)|Not analyzed due to phase 2 study termination||||||
1435881|NCT00965731|Secondary|Plasma Concentration of PF-02341066 and Erlotinib (Phase 2)|Plasma concentration of PF-02341066 and erlotinib when administered in combination during phase 2|Day 1 of cycles 1, 3, and 5 (i.e., up to 15 weeks) at 0 (pre-dose) and 2 to 6 hours post dose|Not analyzed due to phase 2 study termination||||||
1435882|NCT00965731|Secondary|EORTC Quality of Life Questionnaire -Lung Cancer 13 (QLQ-LC13) Score at Phase 2|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination||||||
1435883|NCT00965731|Secondary|European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ-C30) Score at Phase 2|Phase 2 EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline and every 21 days, up to 20 months|Not analyzed due to phase 2 study termination||||||
1435884|NCT00965731|Secondary|Overall Survival (OS) at Phase 2|Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Baseline until death, up to 20 months|Not analyzed due to phase 2 study termination||||||
1435885|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 2)|Percentage of participants during phase 2 with objective response based assessment of confirmed CR or confirmed PR according to RECIST (1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination||||||
1435886|NCT00965731|Secondary|Percentage of Participants With Confirmed CR, PR or Stable Disease (SD) at Phase 2|Percentage of participants during phase 2 with confirmed CR, confirmed PR or SD according to RECIST 1.1. Also known as Disease Control Rate (DCR). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions. SD: neither sufficient shrinkage or increase to qualify for PR or PD.|Week 6 and Week 12|Not analyzed due to phase 2 study termination||||||
1435887|NCT00965731|Secondary|Duration of Response (Phase 2)|Median duration (50%) of tumor response. DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination||||||
1435888|NCT00965731|Secondary|Plasma Level of Soluble Marker: HGF Scatter Factor (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination||||||
1435889|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 2)||Baseline and Day 50 (Cycle 3, Day 1)|Not analyzed due to phase 2 study termination||||||
1435890|NCT00965731|Secondary|Plasma Level of Soluble Marker: Hepatocyte Growth Factor (HGF) Scatter Factor (Phase 1)||Baseline and Day 50 (Cycle 3, Day 1)|Plasma level of soluble marker HGF scatter factor not analyzed due to prior experience with high levels of intra participant variability||||||
1435891|NCT00965731|Secondary|Plasma Level of Soluble Marker: c-Met Ectodomain (Phase 1)|Levels of soluble protein biomarker c-MET was analyzed at Baseline and at Day 50.|Baseline and Day 50 (Cycle 3, Day 1)|The soluble biomarker evaluable population was defined as participants from the safety analysis set of phase 1 who had a soluble protein blood sample taken prior to dosing on Cycle 3 Day 1 and 1 soluble biomarker evaluation after dosing on Cycle 3 Day 1.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1435892|NCT00965731|Secondary|Percentage of Participants With Objective Response (Phase 1)|Percentage of participants during phase 1 with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Confirmed responses: persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of nontarget disease. No new lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|Response Evaluable Population: all participants enrolled into the Phase 1 portion of the study who receive at least one dose of study medication (either PF-02341066 or erlotinib) and have an adequate baseline tumor assessment.|||percentage of participants||95% Confidence Interval|Number
1435893|NCT00965731|Secondary|Duration of Response (Phase 1)|Median duration (50 percent [%]) of tumor response. Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of responses||||||
1435894|NCT00965731|Secondary|Progression-Free Survival (Phase 1)|"Time in weeks from phase 1 randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days until disease progression or unacceptable toxicity|not analyzed due to small number of study participants||||||
1435903|NCT00965731|Secondary|PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1435895|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib Cmax (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||Ratio in percentage||90% Confidence Interval|Geometric Mean
1435896|NCT00965731|Secondary|Ratio of Adjusted Means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) (Phase 1)|Ratio of adjusted means of Erlotinib AUCtau (Crizotinib + Erlotinib / Erlotinib Alone) is a measure of the plasma exposure to erlotinib after erlotinib dosing with crizotinib compared with that after erlotinib dosing alone. In this study, it is used to characterize the effect magnitude of crizotinib on the erlotinib exposure after combinational use of crizotinib and erlotinib.|C1D-1 (i.e., 1 day prior to initiation of continuous dosing of crizotinib) to C1D15 (i.e., 15 days of giving crizotinib and erlotinib)|The PK parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||Ratio in percentage||90% Confidence Interval|Geometric Mean
1435897|NCT00965731|Secondary|Erlotinib Apparent Oral Clearance (CL/F) (Phase 1)|Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, it is used to characterize erlotinib CL/F after multiple doses in combination with PF-02341066 (Cycle 1 Day 15).|C1D15 i.e., 15 days of giving crizotinib and erlotinib|The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1435898|NCT00965731|Secondary|Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1435899|NCT00965731|Secondary|Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15).|C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1435900|NCT00965731|Secondary|Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1)|Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1435901|NCT00965731|Secondary|PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1435902|NCT00965731|Secondary|PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1435925|NCT00965562|Secondary|Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)|DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.|||proportion of participants|||Number
1435904|NCT00965731|Secondary|PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1)|Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib|C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1435905|NCT00965731|Secondary|PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1)|AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib.|Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib|Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1435906|NCT00965731|Primary|Progression-Free Survival (Phase 2)|"Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from AE data (where the outcome was Death; date of death reported in notice of death was used)."|Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity|Not analyzed due to phase 2 study termination||||||
1435907|NCT00965731|Primary|Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)|Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).|Baseline up to Day 28|DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities)|||participants|||Number
1435908|NCT00965718|Primary|Progressive Disease(PD)|Of the 16 patients in the ITT population, progressive disease (PD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||number of participants|||Number
1435909|NCT00965718|Primary|Stable Disease(SD)|Of the 16 patients in the ITT population, stable disease(SD) was confirmed. Disease control rate was calculated based on the number of CR or PR or SD patients in the ITT population.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||number of participants|||Number
1435910|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using Quality of Life Questionnaire Core 30(QLQ-C30) in Patients With Pancreatic Cancer(QLQ-PAN26 Questionnaire)|QLQ-PAN26 consists of questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1435911|NCT00965718|Secondary|Quality of Life (QoL) Assessed Using the Quality of Life Questionnaire Core 30 (QLQ-C30)|QLQ-C30 constitutes a functional scale(physical, role, emotional, cognitive, and social functioning), symptom scores scale(fatigue, nausea/vomiting, pain, dyspnea, constipation, diarrhea, insomnia, appetite loss, financial difficulties), and global QoL scale. With the scores of all scales ranging from 0 to 100, a higher score indicates a better functional scale and a better global QoL scale as well as a worse symptom scores scale.|Every one month from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||units on a scale||Standard Deviation|Mean
1435912|NCT00965718|Secondary|Time to Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||weeks||95% Confidence Interval|Median
1435913|NCT00965718|Secondary|Overall Survival (OS)|OS was calculated from the date of enrollment until death from any cause. And OS was estimated using Kaplan-Meier methods with 95% confidence intervals (CIs).|Every visit, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||weeks||95% Confidence Interval|Median
1435926|NCT00965523|Secondary|Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria and is Complete Response (disappearance of all target lesions) plus Partial Response (at least 30% decrease in sum of longest diameter [LD] of target lesions compared baseline sum of LD). Tumor assessments every 6 weeks.|Every 6 weeks|Full Analysis Set|||percentage of subjects|||Number
1435914|NCT00965718|Primary|Disease Control Rate|"Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). Complete Response: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.~Disease control rate = CR or PR or SD patients / ITT population *100"|Every 2 months from the baseline, up to 16 weeks|Patients who underwent response evaluation at least once were included in the intention-to-treat (ITT) population.|||percentage of participants||95% Confidence Interval|Number
1435915|NCT00965562|Primary|Comparison of the Change in CGI Improvement Scores Among Groups|CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on CGI Improvement scale||Standard Deviation|Mean
1435916|NCT00965562|Primary|Comparison of the Change in DRSP Symptom Scores Among Groups|DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on DRSP scale||Standard Deviation|Mean
1435917|NCT00965562|Primary|Comparison of the Change in CGI-S Symptom Scores Among Groups|CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on CGI-S scale||Standard Deviation|Mean
1435918|NCT00965562|Primary|Comparison of the Change in PMTS Symptom Scores Among Groups|PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on PMTS scale||Standard Deviation|Mean
1435919|NCT00965562|Primary|Comparison of the Change in IDS Symptom Scores Among Groups|IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Intention to treat cohort.|||units on IDS scale||Standard Deviation|Mean
1435920|NCT00965562|Secondary|Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe).|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.|||proportion of participants|||Number
1435921|NCT00965562|Secondary|Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)|"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.~IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe)."|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.|||proportion of participants|||Number
1435922|NCT00965562|Secondary|Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)|Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.|over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit|For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. However, Visit 5 DRSP calendars were missing for an additional 3 subjects in the fluoxetine group and for one subject in each of the calcium and placebo cells.|||proportion of participants|||Number
1435923|NCT00965562|Secondary|Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)|PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.|||proportion of participants|||Number
1435924|NCT00965562|Secondary|Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)|IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.|over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit|Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.|||proportion of participants|||Number
1435927|NCT00965523|Primary|Number of Subjects With Adverse Events.||Every week during treatment and up to 30 days after last dose of study treatment|Safety Analysis Set|||Participants|||Number
1435928|NCT00965497|Secondary|McGill Quality of Life Scale (MQOL)|McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).|8 weeks||||quality of life||Full Range|Mean
1435929|NCT00965497|Primary|Hamilton Depression Scale (HAM-D 17).|Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.|8 weeks|Intention to Treat|||depression severity||Standard Deviation|Median
1435930|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; number of participants with measurement.|||percentage of dyads||95% Confidence Interval|Number
1435931|NCT00965484|Secondary|Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS|||percentage of dyads||95% Confidence Interval|Number
1435932|NCT00965484|Secondary|Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|FAS; N=number of participants with measurement.|||percentage of dyads||95% Confidence Interval|Number
1435933|NCT00965484|Primary|Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®|Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).|2 months|Full analysis set (FAS): all participants who used the new pen at least once to administer Genotropin and who completed the 2-month follow-up questionnaire. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).|||percentage of dyads||95% Confidence Interval|Number
1435934|NCT00965458|Secondary|Hemoglobin A1c|Glycosylated hemoglobin (HbA1c) is a measure of the average plasma concentration of blood sugar (glucose) over the previous three months and measures the level of optimal management of underlying disease. An HbA1c level of 5.6% or less is considered normal. HbA1c levels of 6.5% or higher is typical for individuals with Type 1 Diabetes Mellitus (T1DM). The closer HbA1c levels are to normal, the better controlled the disease is.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||HgbA1c percent (%)||Standard Deviation|Mean
1435935|NCT00965458|Secondary|Major Hypoglycemic Events Occurring From Randomization|Major hypoglycemic events are defined as a glucose concentration <55 mg/dL (grades 2-5, NCI-CTCAE version 3.0), or clinically: involving seizure(s) or involving loss of consciousness (coma), or requiring assistance from another individual in order to recover.|Baseline to Week 52 and Week 52 to Week 104|Intent-to-treat|||Major Hypoglycemic Events|||Number
1435936|NCT00965458|Secondary|Insulin Use in Units Per Kilogram Body Weight Per Day|The need to use insulin is an indication that the body is not producing enough endogenous insulin. Higher amounts of insulin use indicate higher disease activity.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||Units per day divided by weight in kg||Standard Deviation|Mean
1435937|NCT00965458|Secondary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
1438506|NCT00946023|Secondary|Incidence of Chronic GVHD|Percentage of participants who experienced chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
1435938|NCT00965458|Secondary|4-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (Pre-treatment initiation), Week 52, and Week 104|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
1435939|NCT00965458|Primary|2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT)|C-peptide is a substance released by the pancreas into the bloodstream in equal amounts to insulin and reflects how much insulin pancreatic beta cells are making. The standardized MMTT evaluates whether beta cells are producing endogenous insulin. The MMTT was performed in the morning and blood samples for C-peptide collected at baseline (pre-meal) and 15, 30, 60, 90, 120, 150, 180, 210,and 240 minutes post-meal. Results of the stimulated 2-hour (e.g., 120 minutes) post-meal C-peptide AUC are provided. Larger numbers are preferable (better) in these AUC results: more insulin being produced reflects less severe disease. C-peptide levels in the serum (e.g., AUC following a standardized MMTT) compared to control group at 1 year post treatment initiation for the evaluation of investigational products intended to preserve endogenous beta-cell function in T1DM trials is recognized by the Center for Drug Evaluation and Research (CDER) at the FDA as a valid efficacy primary endpoint.|Baseline (pre-treatment initiation), Week 52|Intent-to-treat|||pmol/mL||Standard Deviation|Mean
1435940|NCT00965419|Secondary|Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)|The WAIS-III® was used in the participants aged 17 years or older. Comprehensive reporting on the participant's intellectual ability is not required in this study. Raw scores for each of the 14 subtests are reported. Raw score ranges for each subtest are as follows: picture completion (0-25), vocabulary (0-66), digit symbol coding (0-133), similarities (0-33), block design (0-68), arithmetic (0-22), matrix reasoning (0-26), digit span forward and backward total (0-30), information (0-28), picture arrangement (0-22), comprehension (0-33), symbol search (0-60), letter-number sequencing (0-21), and object assembly (0-52). Higher scores reflect better performance and lower scores reflect lower performance.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WAIS-III assessment.|||units on a scale||Standard Deviation|Mean
1435941|NCT00965419|Secondary|Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)|The fourth edition of the WISC assessment (WISC-IV®) is administered to children ranging from 6 years to 16 years, 11 months. It contains 10 core subtests and 5 supplementary subtests, and takes 65-80 minutes to complete. In this study, Digit Span and Letter-Number Sequencing subtests were completed. Scaled scores range from 1 to 19. Higher scores denote better performance. Lower scores denote worse performance.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WISC-IV assessment.|||units on a scale||Standard Deviation|Mean
1435942|NCT00965419|Secondary|Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)|The WRAT 4 is a norm-referenced test that measures the basic academic skills of word reading, sentence comprehension, spelling, and math computation. There are 2 alternate forms (Blue Form, Green Form) that can be used interchangeably with comparable results. It can be used to evaluate a person aged 5 to 94 years and the administration time is 30 to 45 minutes for children (8 years or older) and adults, and 15 to 25 minutes for young children (ages 5 to 7 years). The age-normed standard scores range from 55 – 145 and for each subtest/composite includes word reading, sentence comprehension, spelling, math computation and reading composite. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WRAT 4 assessment.|||units on a scale||Standard Deviation|Mean
1435943|NCT00965419|Secondary|Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])|The Woodcock Johnson (WJ III ACH) (Woodcock 2001) is designed to measure academic achievement and evaluates a person aged 2 to 90 years and the tool takes 60 to 160 minutes to complete depending on a person’s academic level. The WJ III ACH has 2 parallel forms (A and B) that can be administered in an alternating fashion. The WCJ III ACH uses standard scores (Deviation IQ) with an average standard score of 100 and a standard deviation of 15. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.|Baseline, Week 60|All enrolled participants with baseline and at least one post-baseline WJ III ACH assessment.|||units on a scale||Standard Deviation|Mean
1435944|NCT00965419|Secondary|Mean Change From Baseline of Total Score EQ-5D-3L VAS|"EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 or being worst imaginable health state. Participants aged 12 years or older rated their own health-related quality of life using the EQ-5D-3L VAS scale."|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
1435978|NCT00965419|Primary|Number of Participants With At Least One SAE|Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment.|||Participants|||Count of Participants
1437069|NCT00957801|Primary|Serum Estradiol Measured on Treatment Day 1 (Baseline Study)|Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.|treatment day 1||||pg/mL||Standard Deviation|Mean
1435945|NCT00965419|Secondary|Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent|EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Participants aged 12 years or older rate their own health-related quality of life using EQ-5D-3L.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L assessment.|||units on a scale||Standard Deviation|Mean
1435946|NCT00965419|Secondary|Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child|"EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 being worst imaginable health state. Parents of the participants aged 6 to 11 years complete the EQ-5D-3L form for rating the participants health-related QoL, EQ-5D-3L. i.e., the young child was unable to assess their own quality of life then the parent assessed the child's quality of life."|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
1435947|NCT00965419|Secondary|Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child|The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. Parents of the participants aged 6 to 11 years completed the EQ-5D-3L form regarding the participants health-related quality of life. i.e., young children were unable to assess their own quality of life so the parents assessed the child's quality of life for them.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L assessment.|||units on a scale||Standard Deviation|Mean
1435948|NCT00965419|Secondary|Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent|"The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being best imaginable health state and 0 being worst imaginable health state. Parents of the participants complete EQ-5D-3L form for rating their own health."|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|Parents of the participants completed the EQ-5D-3L form for rating their own quality of life, for parents of participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
1435949|NCT00965419|Secondary|Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life (QoL) instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Parents of the participants completed the EQ-5D-3L form for rating their own quality of life.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|Parents of the participants completed the EQ-5D-3L form for rating their own quality of life, for parents of participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline EQ-5D-3L VAS assessment.|||units on a scale||Standard Deviation|Mean
1435950|NCT00965419|Secondary|Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Child Edition (CHIP-CE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)|CHIP-CE Parent Report Form (PRF) is a parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 156|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CHIP-CE assessment.|||T-score||Standard Deviation|Mean
1435979|NCT00965419|Primary|Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study|Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline SAE assessment.|||percentage of participants|||Number
1435951|NCT00965419|Secondary|Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Adolescent Edition (CHIP-AE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)|CHIP-AE Child Report Form (CRF) is an adolescent rated assessment of their health status and level of functioning. The items in the 5 domains include: Achievement, Satisfaction, Comfort, Risk Avoidance, and Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 156|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CHIP-AE assessment.|||T-score||Standard Deviation|Mean
1435952|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)|CP-CBRS is a comprehensive assessment of a wide spectrum of behaviors, emotions, and academic problems in children and adolescents. It includes DSM-IV-TR symptom scales, empirical and rational scales, other clinical indicators and critical and impairment items. DSM-IV-TR symptom scales assess ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger’s disorder. The age range is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age self-report form (179-item). The parent form of Conners CBRS (CP-CBRS) was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||T-score||Standard Deviation|Mean
1435953|NCT00965419|Secondary|Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Schoolwork/grades, friendships/relationships, home life functioning scores range from 0=never to 3=very often. Raw scores are presented for each subscale with higher scores indicating higher severity and lower scores indicating lower severity.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||units on a scale||Standard Deviation|Mean
1435954|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score CP-CBRS DSM-IV-TR for Oppositional Defiant Disorder (ODD), Anxiety, Conduct Disorder and Major Depressive Episode|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||T-score||Standard Deviation|Mean
1435955|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment.|||T Score||Standard Deviation|Mean
1435980|NCT00965341|Secondary|The Hospital Anxiety and Depression Scale (HADS) and Symptoms Scored by the Edmonton Symptom Assessment Scale (ESAS).|The ESAS assessed 10 symptoms experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and feelings of well-being. The severity of each symptom is rated on a numerical scale of 0–10 (0 = no symptom, 10 = worst possible severity). Depression was assessed using the 14-item HADS questionnaire. Each item on the questionnaire was scored from 0-3. Total Scores for the HADS Questionnaire range from 0 to 42 with higher scores denoting feeling of depression.|Day 29 (+/- 3 days)||||units on a scale||Standard Deviation|Mean
1441671|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||μU/μL||Standard Deviation|Mean
1435956|NCT00965419|Secondary|Mean Change From Baseline of Each Total Score Conners Comprehensive Behavior Rating Scales (CP-CBRS) Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR) for Symptom Subscales Manic Episode and Mixed Episode|The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger’s disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.|Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CP-CBRS assessment. No data was available for mixed episode due to not part of the statistical analysis plan..|||T-score||Standard Deviation|Mean
1435957|NCT00965419|Secondary|Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale|The SNAP-IV ODD subscale includes items #21 to #28. Each item is scored on a 0 to 3 scale (0 = “Not At All”, 1 = “Just A Little”, 2 = “Pretty Much”, 3 = “Very Much”). Score ranges from 0-24. The lowest possible score is 0; highest is 24. Higher scores indicate a greater presence of ODD and lowers scores a lower presence of ODD.|Baseline, Week 12|All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.|||units on a scale||Standard Deviation|Mean
1435958|NCT00965419|Secondary|Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)|The SNAP-IV is a revision of the Swanson, Nolan, and Pelham (SNAP) Questionnaire (Swanson et al 1983). The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of inattention and higher scores a greater intensity. The SNAP-IV ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item in the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of hyperactivity/impulsivity and higher scores, a greater intensity. SNAP-IV ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. A low score of 0 indicates less inattention + hyperactivity/impulsivity. A high score of 54 indicates more inattention + hyperactivity.|Baseline, Week 12|All enrolled participants with baseline and at least one post-baseline SNAP-IV assessment.|||units on a scale||Standard Deviation|Mean
1435959|NCT00965419|Secondary|Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)|The CGI-ADHD-S measures severity of the participants overall severity of ADHD symptoms. The score ranges from 1 to 7 (1=normal, not at all ill; 7=among the most extremely ill participants). LS mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CGI-ADHD-S assessment.|||units on a scale||Standard Error|Least Squares Mean
1435960|NCT00965419|Secondary|Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score)|The ADHDRS-IV-Parent scale measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the 18 items and ranges from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subscale scores ranging from 0 to 27. Higher total and subscale scores are indicative of more severe symptoms. Least-squares (LS) mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.|Baseline, Week 12; Baseline, Week 60; Baseline, Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline ADHDRS-IV-Parent assessment.|||units on a scale||Standard Error|Least Squares Mean
1435961|NCT00965419|Secondary|Number of Participants With Tobacco, Alcohol and Marijuana Use||Week 60 through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline tobacco, alcohol, and marijuana use assessment.|||Participants|||Count of Participants
1435962|NCT00965419|Secondary|Percentage of Participants With Tobacco, Alcohol and Marijuana Use||Week 60 through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline tobacco, alcohol, and marijuana use assessment.|||percentage of participants|||Number
1435963|NCT00965419|Secondary|Number of Participants in Sexual Maturation on Tanners Scale|Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|Baseline Up to Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Tanners scale assessment.|||Participants|||Count of Participants
1435964|NCT00965419|Secondary|Percentage of Participants in Sexual Maturation on Tanners Scale|Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.|Baseline Up to Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Tanners scale assessment.|||percentage of participants|||Number
1435965|NCT00965419|Secondary|Survival Curve Time to Response||Week 12|Zero participants were analyzed for this outcome measure. Data was not collected for this outcome for participants due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636]). This outcome measure was not applicable to roll-over participants.||||||
1435966|NCT00965419|Secondary|Number of Participants With a Response Rate||Week 12|Zero participants were analyzed for this outcome measure. Data was not collected for this outcome for participants due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636]). This outcome measure was not applicable to roll-over participants.||||||
1435967|NCT00965419|Secondary|Percentage of Participants With Response Rates||Week 12|Zero participants were analyzed for this outcome measure, due to all participants being roll-over from two previous edivoxetine trials (LNBJ [No NCT number]) and (LNBF [NCT00922636])This outcome measure and analysis was not applicable to roll-over participants.||||||
1435968|NCT00965419|Secondary|Mean Change From Baseline Z-Score in Body Mass Index (BMI)||Baseline, Week 60; Baseline, Week 240|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.|||Z-Score||Standard Deviation|Mean
1435969|NCT00965419|Secondary|Mean Change From Baseline Z-Score for Weight|A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).|Baseline, Week 60; Baseline, Week 240|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.|||Z-Score||Standard Deviation|Mean
1435970|NCT00965419|Secondary|Mean Change From Baseline Z-scores for Height|A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).|Baseline, Week 60; Baseline, Week 240|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline Z-score assessment.|||Z-Score||Standard Deviation|Mean
1435971|NCT00965419|Secondary|Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category|Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide.|Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u)|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline CSSRS assessment.|||percentage of participants|||Number
1435972|NCT00965419|Secondary|Number of Participants Who Discontinued Due to Any Reason||Baseline Through Week 252|All enrolled participants who had evaluable discontinuation data.|||Participants|||Count of Participants
1435973|NCT00965419|Secondary|Percentage of Participants Who Discontinued Due to Any Reason||Baseline Through Week 252|All enrolled participants who had evaluable discontinuation data.|||Percentage of participants|||Number
1435974|NCT00965419|Secondary|Number of Participants With At Least One DCAEs||Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline DCAE assessment.|||Participants|||Count of Participants
1435975|NCT00965419|Secondary|Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)||Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation.|||percentage of participants|||Number
1435976|NCT00965419|Secondary|Number of Participants With At Least One TEAE|Number of participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment.|||Participants|||Count of Participants
1435977|NCT00965419|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|Percentage of Participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through Week 252|All enrolled participants who did not discontinue from the study for the reason 'Lost to follow up' at the first post-baseline observation and who had baseline and at least one post-baseline TEAE assessment.|||percentage of participants|||Number
1435997|NCT00965185|Secondary|Lipid Profile|12 month change in lipid profile|Measured at baseline and 1 year|All available data were used.|||mmol/L||95% Confidence Interval|Mean
1435981|NCT00965341|Primary|Functional Assessment of Cancer Therapy-Fatigue Subscale (FACIT-F) at Day 29 (+/- 3 Days)|The primary endpoint was to evaluate the effect of testosterone replacement therapy on fatigue in hypogonadic male patients with advanced cancer, measured by the Functional Assessment of Cancer Therapy-Fatigue subscale (FACIT-F) at day 29 (+/- 3 days). FACIT-F consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional, and functional), plus a 13-item fatigue subscore. The participant rates the intensity of fatigue and its related symptoms on a scale of 0–4. The FACIT-F total score ranged between 0 and 108, with higher scores denoting improved function. The FACIT-F Fatigue Subscale ranges from 0 to 52, with higher scores represent better (less) fatigue than a lower score. A positive difference score (29 days minus baseline) represents improvement. A greater positive difference score represents greater improvement.|Day 29 (+/- 3 days)||||units on a scale||Standard Deviation|Mean
1435982|NCT00965263|Secondary|Plasma Cocaine|Plasma cocaine levels in Week 3 and Week 13 as a function of cocaine dose in High and Low AB groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher plasma levels of cocaine.|13 weeks|Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received.|||ng/mL||Standard Error|Mean
1435983|NCT00965263|Secondary|Cocaine Cardiovascular Effects|Heart rate levels in Week 3 and Week 13 as a function of cocaine dose in High and Low antibody groups. Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate higher heart rates.|13 weeks|Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received.|||BPM||Standard Error|Mean
1435984|NCT00965263|Primary|Cocaine Intoxication|Visual Analogue Scale ratings (0-100mm) of the Good Drug Effect cluster (“Good Drug Effect,” “High,” “Stimulated”) over 13 weeks as a function of cocaine dose (25mg or 50mg). Participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups based on their peak antibody levels at Week 13. Higher numbers indicate more agreement with the statements.|13 weeks|Peak plasma antibody levels were highly variable. Thus, participants (n=10) were evenly divided into High Antibody (AB) and Low Antibody (AB) groups for analysis, based on their peak antibody levels at Week 13, rather than by the dose of vaccine received.|||units on a scale||Standard Error|Mean
1435985|NCT00965250|Secondary|Correlate Response to Therapy With Changes in FDG-PET Imaging|Participants with scans that showed neither sufficient shrinkage to qualify as an objective response nor sufficient increase to qualify as disease progression, taking as reference the smallest cumulative longest dimension since start of treatment, to have stable disease.|6 weeks after initiation of treatment|We did radiological assessment ourselves, and an independent radiological assessment was not undertaken for assessment of response or progression.||||||
1435986|NCT00965250|Secondary|Median Number of Cycles of Therapy|A cycle is defined as 21 days or 6 weeks of therapy.|6 weeks||||Cycles||Full Range|Median
1435987|NCT00965250|Secondary|Overall Survival|Time from treatment start date until date of death or date last known alive.|39 months||||Months||95% Confidence Interval|Median
1435988|NCT00965250|Secondary|Time to Progression|Time between the first day of treatment to the day of disease progression.|39 months||||Months||95% Confidence Interval|Median
1435989|NCT00965250|Secondary|Disease Control Rate (DCR)|Disease control rate is defined as objective response plus stable disease.|39 months||||percentage of participants||95% Confidence Interval|Number
1435990|NCT00965250|Secondary|Percentage of Participants Who Respond to Treatment|Percentage of participants who respond to treatment was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|39 months||||percentage of participants||95% Confidence Interval|Number
1435991|NCT00965250|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|81 months and 17 days|Adverse events are not separated by group because the adverse events are related to the drug which was the same in both groups.|||Participants|||Number
1435992|NCT00965250|Primary|Objective Response Rate (Partial Response (PR)+Complete Response (CR)) to IMC-A12 Monotherapy in Patients With Advanced or Recurrent Thymoma or Thymic Carcinoma.|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Patients were assessed for response every 2 cycles (every 6 weeks) while receiving the study drug.||||Participants|||Number
1435993|NCT00965237|Primary|Overall Satisfaction With the Lenses|Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.|1 week of wear|Analysis conducted per protocol|||Units on a Scale||Standard Deviation|Mean
1435994|NCT00965185|Secondary|Liver Function Tests (LFTs)|"Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).~For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.~ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L"|Measured at baseline, 1, 3, 6, 9, and 12 months|All available data were used.|||participants|||Number
1435995|NCT00965185|Secondary|Adipocytokines|12 month change in IL-6|Measured at baseline and 1 year||||pg/ml||95% Confidence Interval|Mean
1435996|NCT00965185|Secondary|C-reactive Protein (CRP)|12 month change in Log CRP concentration|Measured at baseline and 1 year|All available data were used.|||log(mg/L)||95% Confidence Interval|Mean
1436001|NCT00965185|Primary|Coronary and Aortic Plaque Inflammation|12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)|Measured at baseline and 1 year|All participants with baseline and 12 month PET and CT scans of acceptable image quality to permit assessment of change over time in identical regions in serial scans. As a result, only a limited number of participants could be included.|||ratio||95% Confidence Interval|Mean
1436002|NCT00965146|Primary|Evaluate Complication Rate.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years|||||||
1436003|NCT00965146|Primary|Evaluate Component Design Effect on Functional Knee Society Score and Radiographic Findings.|This study was terminated prior to the protocol defined 15 year endpoint. As such, final outcome measures cannot be posted.|15 years|||||||
1436004|NCT00965094|Secondary|Change in Renal Function (Creatinine Slope)|X(slope)=(1/value of creatinine).|3 months, 5 months, 7 months, 9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).|||mg/dl per month||Standard Deviation|Mean
1436005|NCT00965094|Secondary|Participants Who Had Occurrence of Treatment Failure.|Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity or conversion to another regimen.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method)|||Participants|||Number
1436006|NCT00965094|Secondary|Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death.|Biopsy-proven acute rejection was defined as a biopsy gradeed IA, IB, IIA, IIB, or III. The allograft was presumed to be lost if the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable|||Participants|||Number
1436007|NCT00965094|Secondary|Assessment of GFR by the Cockcroft-Gault Method (LOCF)|the GFR was also calculated using the Cockcroft-Gault method (Cockcroft and Gault 1976) and the Modification of Diet in Renal Disease (MDRD) method (Levey et al., 1999, Rodrigo et al., 2003; Pierrat et al., 2003).Cockcroft-Gault formula For men: GFR= (140-Age)X Body Weight[kg]/72X Serum Creatinine[mg/dl] For women: GFR= 0,85x(140-Age) x Body Weight[kg]/72x Serum Creatinine [mg/dl] The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable|||mL/min||Standard Deviation|Mean
1436008|NCT00965094|Primary|Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF)|The glomerular filtration rate (GFR) is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. The GFR, calculated according to the Nankivell formula, was used as the primary outcome measure in this study. This equation has been validated in renal transplant patients against the true GFR measured by a radionuclide method and has been confirmed as a very accurate method to calculate the GFR in this specific population (Gaspari et al., 2004)GFR = 6.7 / Scr + BW / 4 – Surea / 2-100 / (height)² + C Scr = serum creatinine concentration expressed in mmol/L. BW = body weight in kg, Surea = serum urea in mmol/L and Height is expressed in meters.The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis.|9 months|The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method).|||mL/min/1.73m^2||Standard Deviation|Mean
1436009|NCT00965081|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.~Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.~Suicidal ideation: a “yes” answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation."|Baseline through 12 weeks|Only participants having at least 1 post-baseline C-SSRS assessment were included in this analysis.|||Participants|||Number
1436010|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)|SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint.|||Units on a scale||Standard Error|Least Squares Mean
1436011|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)|"The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.~The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline."|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
1441672|NCT00923260|Primary|Components of Metabolic Syndrome (Insulin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||μU/μL||Standard Deviation|Mean
1436012|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per randomly assigned groups. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy(DB) due to adverse event; last non-missing observation during initial DB used to impute the missing endpoint for all others.|||Units on a scale||Standard Error|Least Squares Mean
1436013|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
1436014|NCT00965081|Secondary|Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint|"The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).~The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
1436015|NCT00965081|Secondary|Patient Global Impression - Improvement (PGI-I) at Endpoint|"The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is very much better, 4 is no change, and 7 is very much worse. Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S)."|12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
1436016|NCT00965081|Secondary|Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form|BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.|Baseline, 12 weeks|Intention to treat (ITT) population: analyses conducted per initial group assignments. The LOCF method was used to impute the missing endpoint during initial double-blind therapy.|||Units on a scale||Standard Error|Least Squares Mean
1436017|NCT00965081|Primary|"Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.|Baseline, 12 weeks|Intent-to-treat (ITT) population: all randomized participants. ITT treatment group is group to which participant was randomized regardless of treatment actually received. BOCF method used to impute endpoint value if initial DBT discontinued due to AE. Change from baseline analyses included all those with baseline and ≤1 post-baseline observation.|||Units on a scale||Standard Error|Least Squares Mean
1436018|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive cognitive behavioral therapy or to no cognitive behavioral therapy (behavioral effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores|||Units on a scale.||Standard Error|Mean
1436019|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to cognitive behavioral therapy to or no behavior therapy comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.|||units on a scale||Standard Error|Mean
1436020|NCT00964886|Secondary|Roland and Morris Disability Questionnaire|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|All participants assigned at baseline to receive desipramine hydrochloride or benztropine mesylate (drug effect). This is an 'as randomized' Intent-to-Treat analysis. Values are mean scores at Week 12 (or last observation carried forward). Means are adjusted for baseline Roland and Morris scores|||Units on a scale.||Standard Error|Mean
1436021|NCT00964886|Primary|Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity|"The DDS is self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values."|12 weeks after baseline (or last observation carried forward)|We conducted an intent-to-treat analysis of all randomized participants assigned to desipramine or to active drug placebo (benztropine) comparing mean DDS pain intensity at Week 12 (or the last observation carried forward) adjusted for mean baseline score.|||units on a scale||Standard Error|Mean
1436022|NCT00964860|Secondary|Whole Mouth Mean Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|"Whole-mouth average MGI scores were calculated separately for each subject and visit by averaging the MGI scores of all gradable sites. Interpoximal average MGI scores were also calculated for each subject and visit by averaging over only interpoximal sites (buccal-mesial, buccal-distal, lingual-mesian, and lingual-distal).~Within each treatment, changes from baseline were analyzed using paired t-test. Between treatments mean comparisons were conducted using analysis of covariance with baseline MGI score as a covariate. All statistical comparisons were two-sided with a 5% significance level.~The average MGI score for a subject can range from 0 (no gingivitis) to 4 (inflammation on all gradable sites)."|30 days|per protocol|||units on a scale||Standard Error|Least Squares Mean
1436023|NCT00964860|Primary|Mean Interproximal Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group|Gingivitis was scored using the Lobene Modified Gingival Index (a visual examination for inflammation) on all scorable teeth. For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored on a 5-point, categorical scale (0 = absence of inflammation; 4 = severe inflammation) corresponding to Inflammation|30 days|per protocol|||units on a scale||Standard Error|Mean
1436024|NCT00964795|Other Pre-specified|Summary of Study Duration (Weeks)|Study Duration = (last visit/ discontinuation date - first dose date + 28)/7|Baseline through end of treatment (Week 180)||||weeks||Standard Deviation|Mean
1436025|NCT00964795|Other Pre-specified|Summary of Treatment Duration (Weeks)|Treatment Duration = (last dose date - first dose date + 28)/7|Baseline through end of treatment (Week 180)||||weeks||Standard Deviation|Mean
1436026|NCT00964795|Secondary|Change in BCVA Letter Score (mLOCF)|"The secondary endpoint in the study is the change in BCVA letter score from baseline through Week 116.~(mLOCF: The last non-missing observation prior to the missing visit was carried forward to impute the missing data; no imputation after last visit; no baseline value carried forward)."|Baseline through Week 116||||letters correctly read||Standard Deviation|Mean
1436027|NCT00964795|Primary|Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD|"The primary endpoint in the study is the safety and tolerability of Intravitreal Aflibercept Injection in patients with neovascular AMD (Age-related Macular Degeneration) from day 1 through the end of treatment visit (week 180) based on the number of participants who experienced any treatment-emergent adverse event (TEAE).~Treatment-emergent adverse events were categorized according to Ocular TEAEs in the study eye, Ocular TEAEs in the fellow eye, and Non-Ocular TEAEs"|Baseline (day 1) through end of treatment (Week 180)||||participants|||Number
1436028|NCT00964743|Secondary|CSF and Serum Vascular Endothelial Growth Factor (VEGF) Levels|CSF and serum VEGF levels were to be measured over time, and the means and standard errors of the respective VEGF levels were to be plotted at specific sampling time points. The respective VEGF levels may also have been correlated with patients’ PFS, OS, or cytology using descriptive statistical methods similarly as mentioned above. The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
1436029|NCT00964743|Secondary|Sorafenib Levels in Cerebrospinal Fluid (CSF)|CSF sorafenib level was to be measured over time, and the means and standard errors of the sorafenib level were to be plotted at specific sampling time points. CSF sorafenib levels may also have been correlated with patients’ PFS, OS, or cytology using descriptive statistical methods (e.g., KM analysis stratified by high vs. low CSF sorafenib levels). The log transformation of lab values were to be employed on the continuous variables whenever necessary.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
1436030|NCT00964743|Secondary|Number of Participants With Overall Survival (OS)|Several secondary endpoints were to be analyzed in a descriptive fashion. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
1436031|NCT00964743|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|Kaplan-Meier analysis of PFS was to be performed and the PFS at 6 months in the study patients were be empirically described. All patients were to be followed up until death.|6 Months|The study closed early due to low accrual of 2 of 10 expected patients. Neither patient completed 8 weeks of treatment as outlined in the protocol. Both patients expired before reaching the 6 month Progression Free Survival endpoint.||||||
1436033|NCT00964678|Secondary|Change in Tricuspid Annular Plane Systolic Excursion|Higher values indicate a better outcome.|baseline and 6 months|The patient excluded from the analysis was unable to be present for the final echo-cardiogram due to lack of transportation and distance from the hospital. Multiple attempts to schedule the study test were made through phone and email.|||centimeters|||Number
1436034|NCT00964678|Secondary|Change in 6 Minute Walk Distance||baseline and 6 months|The patient who was excluded from analysis developed an orthopedic injury during the study and was unable to complete the walking test at conclusion of the study|||feet|||Number
1436035|NCT00964678|Secondary|Change in Right Ventricular End Systolic Volume|right ventricular end systolic volume determined by MRI|baseline and 6 months||||mL|||Number
1436036|NCT00964678|Primary|Absolute Change in Right Ventricular Ejection Fraction|Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only|baseline, 6 months|Patients with right heart catheterization confirmed pulmonary arterial hypertension, already on pulmonary vasodilator therapy|||% RVEF||95% Confidence Interval|Mean
1436037|NCT00964548|Secondary|Transcranial Doppler Mean Flow Velocity (Change From Baseline Mean Flow Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Mean flow velocities of vessel in vasospasm (Change from baseline mean flow velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion||||cm/s||95% Confidence Interval|Mean
1436038|NCT00964548|Secondary|Transcranial Doppler Peak Systolic Velocity (Change From Baseline Peak Systolic Velocity (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Peak Systolic Velocity of vessel in vasospasm (Change from baseline peak systolic velocity (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion||||cm/s||95% Confidence Interval|Mean
1436039|NCT00964548|Primary|Hemodynamic Parameters (Change From Baseline Systolic Blood Pressure (Pre-infusion) Over Time Until 135 Minutes Post-infusion)|Systolic Blood Pressure (Change from baseline systolic blood pressure (pre-infusion) over time until 135 minutes post-infusion).|baseline until 135 minutes post-infusion||||mmHg||95% Confidence Interval|Mean
1436040|NCT00964496|Primary|Cessation of Bleeding|The cessation of bleeding was defined as repeated negative faecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period. Rebleeding was defined based on a positive FOBT at any visit after treatment.|52 months||||participants|||Number
1436041|NCT00964496|Secondary|Change From Baseline in Total Transfused Red Cell Requirements at 12 Months|Change of total transfused red cell requirements at 12 months after randomization from one year before baseline in transfusion dependent patients|baseline and 12 months|There are 14 participants depended on blood transfusion in each group|||milliliter||Standard Deviation|Mean
1436042|NCT00964496|Secondary|Participants Dependent on Blood Transfusions|Numbers of participants dependent on blood transfusions|52 months|55 patients were enrolled in our study. One in iron-controlled group refused to continue for personal reason after 8 months, two other in thalidomide plus iron group refused to take study medications after 4 weeks treatment due to leukopenia and unexplained somnolence. Analysis was performed according to Intention-to-Treat principle.|||participants|||Number
1436043|NCT00964496|Secondary|Change From Baseline in Bleeding Duration at 12 Months|The change from baseline in bleeding duration at 12 months|baseline and 12 months||||days||Standard Deviation|Mean
1436044|NCT00964496|Secondary|Change From Baseline in Bleeding Episodes at 12 Months|The Change from baseline in bleeding episodes at 12 months|baseline and 12 months||||bleeding episodes||Standard Deviation|Mean
1436045|NCT00964496|Secondary|Change From Baseline in Hemoglobin (Hb) Level at 12 Months|The change from baseline in average hemoglobin (Hb) level(tested every month) at 12 months.|baseline and 12 months||||g/L||Standard Deviation|Mean
1436046|NCT00964496|Primary|Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months|The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Reduction of rebleeds = [(total bleeding episode at 12 months - total bleeding episodes at a year before randomization)/total bleeding episodes at a year before randomization(baseline)]*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.|baseline and 12 months||||participants|||Number
1436047|NCT00964444|Primary|Force Exerted on a Fetus as the Delivery Occurs|The amount of force exerted on the fetus was measured in ounces. It was calculated based on measurements from the force transducers in the platform. The obstetrician stands or sits on the platform as the infant is delivered.|Assessment was done after the delivery||||ounces||Standard Deviation|Mean
1436048|NCT00964431|Primary|Total Patient Pain Relief Over 0 to 8 Hours.|"Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 32."|8 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
1436049|NCT00964392|Secondary|Percentage of Subjects Experienced Serious Adverse Events.|The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).|First study day to 5 year post-ablation|Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one SAE, was excluded from this analysis since the subject discontinued prior to RF ablation.|||percentage of participants|||Number
1436067|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1441673|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mg/dl||Standard Deviation|Mean
1436050|NCT00964392|Primary|The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.|The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.|Seven days post ablation procedure|Safety population, which is defined as those subjects who underwent study catheter insertion. However subject LUC-030, who experienced one primary AE, was excluded from this analysis since the subject discontinued prior to RF ablation.|||percentage of participants||95% Confidence Interval|Number
1436051|NCT00964366|Secondary|Skin Hydration|Evaluation of Skin Hydration using electrical conductance measurements,on weekdays during 14 days of treatment. The value recorded which is expressed in units of microsiemens represents the AC conductance 2-3 seconds after placing the spring-loaded probe tip to the sample site.|2 weeks|ITT|||Microsiemens||Standard Deviation|Mean
1436052|NCT00964366|Secondary|Sebum Measurements|To sample the skin surface, the sebum collector strips are applied to the skin sites for 10 seconds. Once removed, these samples will be immediately measured for the amount of sebum on the strip using the tape analyzer. The amount of sebum production was measured as the amount of sebum collected on a tape applied to the skin for 10 seconds and then converted to 1 of 10 incremental levels. Sebum production was measured in increments of 0 (minimum value) to 10 (maximum value). The higher the number, the greater amount of sebum produced.|2 weeks|ITT|||units on a scale||Standard Deviation|Mean
1436053|NCT00964366|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1through Day 14|ITT|||Units on a scale||Standard Deviation|Mean
1436054|NCT00964366|Secondary|Transepidermal Water Loss (TEWL)|To assess skin moisture and hydration using transepidermal water loss (TEWL). These tables record the data obtained for each panelist at Baseline, and on Days 3, 7 and 14 or upon early termination of site(s), if applicable. Results are measured on a continuous scale.|2 Weeks||||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
1436055|NCT00964366|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|2 Weeks|ITT|||Units on a scale||Standard Deviation|Mean
1436056|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436057|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436058|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 8|ITT. All participants were asked to respond to the questionnaire.|||Units on a scale||Standard Deviation|Mean
1436059|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.|Week 1, Week 2|ITT. All participants were asked to respond to the questionnaire.|||Units on a scale||Standard Deviation|Mean
1436060|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 8|ITT|||Participants|||Number
1436061|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment|Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).|Week 1, Week 2|ITT|||Participants|||Number
1436062|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 8|ITT|||Participants|||Number
1436063|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin|Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).|Week 1, Week 2|ITT|||Participants|||Number
1436064|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No|Week 8|ITT|||Participants|||Number
1436065|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Compliance|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1452602|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 08 from Baseline (i.e., between -45 days and +12 months)||||mg/dL||Standard Deviation|Mean
1436068|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436069|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?|Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.|Week 1, Week 2|ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit.|||Participants|||Number
1436070|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436071|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436072|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436073|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436074|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436075|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436076|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436077|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436078|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436079|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436080|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436081|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436082|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436083|NCT00964223|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness|Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436084|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Global Score|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436085|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Functional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1437066|NCT00957801|Primary|Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)|Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.|treatment day 8||||ng/mL||Standard Deviation|Mean
1436086|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Emotional Domain|"Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436087|NCT00964223|Secondary|Skindex-29 Quality of Life Questionnaire - Symptomatic Domain|"Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain."|Baseline, and Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436088|NCT00964223|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Week 5, Week 8|ITT|||total acne lesions||Standard Deviation|Mean
1436089|NCT00964223|Secondary|Non-Inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Week 5, Week 8|ITT|||non-inflammatory acne lesions||Standard Deviation|Mean
1436090|NCT00964223|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Week 5, Week 8|ITT|||inflammatory acne lesions||Standard Deviation|Mean
1436091|NCT00964223|Secondary|Investigator Static Global Assessment Score|ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436092|NCT00964223|Secondary|Irritant/Allergic Contact Dermatitis Score|Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436093|NCT00964223|Secondary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436094|NCT00964223|Secondary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436095|NCT00964223|Secondary|Erythema (Redness) Score|Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 5, Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1436096|NCT00964223|Primary|Erythema (Redness) Score|Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436097|NCT00964223|Primary|Irritant/Allergic Contact Dermatitis Score|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face.~Erythema,peeling, and dryness were graded using the following scale:~0 None~Slight~Moderate~Intense"|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436098|NCT00964223|Primary|Skin Peeling Score|Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.|Week 1, Week 2|ITT|||Units on a scale||Standard Deviation|Mean
1436099|NCT00964223|Primary|Skin Dryness Score|Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.|Week 1, Week 2|Intent-to-Treat (ITT) Population|||Units on a scale||Standard Deviation|Mean
1436100|NCT00964158|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1436101|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1436113|NCT00964158|Secondary|Titers for Serum Neutralizing Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Titers||95% Confidence Interval|Geometric Mean
1436102|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day (Days 0-20) follow-up period after the first vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1436103|NCT00964158|Secondary|Number of Subjects With Normal or Abnormal Biochemical Levels|Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.|At Days 0, 21 and 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1436104|NCT00964158|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1436105|NCT00964158|Secondary|Number of Subjects With Any Medically-attended Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the entire study period (from Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1436106|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
1436107|NCT00964158|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
1436108|NCT00964158|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.|||Participants|||Count of Participants
1436109|NCT00964158|Secondary|Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies|A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.|At Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1436110|NCT00964158|Secondary|Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies|A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.|At Days 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
1436111|NCT00964158|Secondary|Titers for Serum Neutralizing Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.|At Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Titers||95% Confidence Interval|Geometric Mean
1436112|NCT00964158|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.|At Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1436114|NCT00964158|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.|At Days 0, 21 and 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
1436115|NCT00964158|Secondary|Seroconversion Factor (SCF) for HI Antibody Titers|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Days 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Fold increase||95% Confidence Interval|Geometric Mean
1436116|NCT00964158|Secondary|Number of Seroprotected Subjects in Terms of HI Antibodies|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Days 0, 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1436117|NCT00964158|Secondary|Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies|A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.|At Days 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1436118|NCT00964158|Secondary|Titers for Serum HI Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Days 0, 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Titers||95% Confidence Interval|Geometric Mean
1436119|NCT00964158|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.|At Days 0, 21, 42 and at Month 12|The analysis was performed on the ATP cohort for persistence at Month 12, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against the study vaccine antigen component at Month 12.|||Participants|||Count of Participants
1436120|NCT00964158|Primary|Seroconversion Factor (SCF) for HI Antibody Titers|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Fold increase||95% Confidence Interval|Geometric Mean
1436121|NCT00964158|Primary|Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies|Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
1436122|NCT00964158|Primary|Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies|A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
1436123|NCT00964158|Primary|Titers for Serum HI Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Titers||95% Confidence Interval|Geometric Mean
1436124|NCT00964158|Primary|Titers for Serum HI Antibodies|Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Titers||95% Confidence Interval|Geometric Mean
1436164|NCT00963872|Secondary|Non-Relapse Mortality|Deaths not due to relapse.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436125|NCT00964158|Primary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
1436126|NCT00964158|Primary|Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value|The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).|At Day 0|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom 2 doses were taken and assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second vaccine dose given at Day 21.|||Participants|||Count of Participants
1436127|NCT00964119|Primary|Skeletal Toxicities Related to the Use of Isotretinoin|Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy|Baseline to 5 months post therapy|Pilot observational study; Principal Investigator left sponsoring institution, data analysis not completed. Data analysis based on interim data (12 subjects). No manuscript published. No final analysis expected. Study has been closed with the local IRB and files archived.|||U/L||Standard Deviation|Mean
1436128|NCT00964028|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (from Day 0 until Month 3 or Month 4)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1436129|NCT00964028|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1436130|NCT00964028|Primary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.|During the 4-day (Days 0-3) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1436131|NCT00964028|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) follow-up period after each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1436132|NCT00963937|Secondary|Percentage of Participants Who Used Rescue Medication Between the Time of Dosing and 240 Minutes Post-Treatment|Rescue medication included one of the following: a single oral dose of a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, not to exceed the maximum recommended single dose; and anti-emetics (a drug to prevent vomiting).|within 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the observed case dataset, a dataset without any imputation of missing data.|||percentage of participants|||Number
1436133|NCT00963937|Secondary|Percentage of Participants Who Were Free of Vomiting at 30, 60, 120, and 240 Minutes Post-Treatment|"Vomiting is one of the associated symptoms of a migraine. A participant was assessed as being free of vomiting when the symptom was recorded as absent at each time point in his or her patient diary. Vomiting was recorded as present for all subsequent assessments if a participant took a rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had vomiting at the time of treatment were included in the denominator.|||percentage of participants|||Number
1436134|NCT00963937|Secondary|Percentage of Participants Who Were Nausea Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Nausea is one of the associated symptoms of a migraine. A participant was assessed as nausea free when the symptom was recorded as absent at each time point in his or her patient diary. Nausea was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had nausea at the time of treatment were included in the denominator.|||percentage of participants|||Number
1436135|NCT00963937|Secondary|Percentage of Participants Who Were Phonophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Phonophobia (sensitivity to sound) is one of the associated symptoms of a migraine. A participant was assessed as phonophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Phonophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had phonophobia at the time of treatment were included in the denominator.|||percentage of participants|||Number
1436165|NCT00963872|Secondary|Incidence of Grades II-IV Graft-vs-host Disease|Development of graft-versus-host disease through day 100.|Day 0 through Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1452603|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 07 from Baseline (i.e., between -45 days and +9 months)||||mg/dL||Standard Deviation|Mean
1436136|NCT00963937|Secondary|Percentage of Participants Who Were Photophobia Free at 30, 60, 120, and 240 Minutes Post-Treatment|"Photophobia (sensitivity to light) is one of the associated symptoms of a migraine. A participant was assessed as photophobia free when the symptom was recorded as absent at each time point in his or her patient diary. Photophobia was recorded as present for all subsequent assessments if a participant took rescue medication."|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset. Only participants who had photophobia at the time of treatment were included in the denominator.|||percentage of participants|||Number
1436137|NCT00963937|Secondary|Percentage of Participants Who Were Pain Free at 30, 60, 120, and 240 Minutes Post-Treatment|Pain free was defined as a post-treatment pain intensity score of 1 on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took a rescue medication. The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 =mild, 3=mild to moderate, 4=moderate to severe, and 5=severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.|||percentage of participants|||Number
1436138|NCT00963937|Secondary|Percentage of Participants Who Reported Pain Relief at 30, 60, 120, and 240 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|30, 60, 120, and 240 minutes post-treatment (Randomization through Final Visit [Week 6])|FAS. The analysis was performed on the LOCF dataset.|||percentage of participants|||Number
1436139|NCT00963937|Primary|Percentage of Participants Who Reported Pain Relief at 120 Minutes Post-Treatment|Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.|120 minutes post-treatment (Randomization through Final Visit [Week 6])|Full Analysis Set (FAS): all participants in the Safety Population (all participants who took >=1 dose of investigational product [IP]) who provided any post-treatment efficacy assessment. Analysis was performed on the last observation carried forward (LOCF) dataset (imputed by LOCF method). Only post-treatment values were used for imputation.|||percentage of participants|||Number
1436140|NCT00963924|Secondary|Side Effects Checklist (SEC)|Each side effect is entered as either yes or no for having had any severity of the side effect at each visit.|Weeks 0 - 8, and Month 6 after cognitive remediation completion|18 participants in each arm had baseline data available for analysis. At week 8, 17 participants in the D-cycloserine group and 15 in the placebo group had data available. At month 6, 6 participants in the D-cycloserine group and 4 in the placebo group had data available.|||Participants|||Count of Participants
1436141|NCT00963924|Secondary|Clinical Global Impression (CGI)|"Considering you total clinical experience with this patient population, how mentally ill is the patient at this time?~1=Normal, not at all, 2=Borderline mentally ill, 3=Mildy ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, 7=Among the most extremely ill patients; a higher score indicates worse outcome"|Weeks 0 and 8, and Month 6 after cognitive remediation completion|18 participants in each arm had baseline data available for analysis. At week 8, 17 participants in the D-cycloserine group and 15 in the placebo group had data available. At month 6, 6 participants in the D-cycloserine group and 4 in the placebo group had data available.|||units on a scale||Standard Deviation|Mean
1436142|NCT00963924|Secondary|Calgary Depression Scale for Schizophrenia (CDSS)|Baseline scores on the Calgary Depression Scale for Schizophrenia (CDSS). Total CDSS scores range from 0-27. The assessment is comprised of 9 questions covering the topics of Depression, Hopelessness, Self Depreciation, Guilty Ideas of Reference, Pathological Guilt, Morning Depression, Early Wakening, Suicide, Observed Depression. Each item is scored on a scale from 0-3 (0 = absent, 1 = mild, 2 = moderate, 3 = severe). The total score is computed by adding up the individual scores of each item. The higher the score, the more prominent the symptoms of depression are for the participant.|Baseline||||units on a scale||Standard Deviation|Mean
1436143|NCT00963924|Secondary|Heinrich Quality of Life Scale (QoL)|Baseline scores of the Heinrich Quality of Life Scale, a 21 item scale designed and validated to measure intrapsychic foundations, interpersonal relations, instrumental role, and common objects and activities in patients diagnosed with Schizophrenia. Patients are rated on each of the 21 items on a scale of 0-6. Total scores are computed by adding up the scores of each individual item, with a total score ranging from 0-126. Higher scores reflect higher functioning.|Baseline||||units on a scale||Standard Deviation|Mean
1436144|NCT00963924|Secondary|Global Assessment of Functioning Scale (GAS)|The Global Assessment of Functioning Scale (GAS) measured at baseline. This scale measures social, occupational, and psychological functioning, on a scale of 0-100. The higher the score, the greater a participant's functioning level.|Baseline||||units on a scale||Standard Deviation|Mean
1436145|NCT00963924|Secondary|Positive and Negative Syndrome Scale (PANSS)|The baseline score on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. The higher a score the more prominent a positive symptom is.|Baseline||||units on a scale||Standard Deviation|Mean
1436166|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 28|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
1436146|NCT00963924|Primary|Auditory Discrimination Task: Interstimulus Interval (ISI)|The auditory discrimination task involved trials in which the subject differentiated between rapidly-presented frequency-modulated sweeps separated by a short interstimulus interval (ISI). In this task, sustained successful performance is more difficult with shorter stimulus presentations and ISIs (which were equal within a trial). Thus, our dependent measure was the shortest stimulus duration/ISI, in ms, for trials in which subjects were able to perform the task at 85% accuracy, referred to as ISI for simplicity. The shorter the score the better the performance on the task. Scores are reported for baseline and week 8.|Baseline vs. Week 8|18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.|||milliseconds||Standard Deviation|Mean
1436147|NCT00963924|Primary|Scale for Assessment of Negative Symptoms (SANS)|The total scores from baseline and week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores are reported for baseline and week 8.|Baseline vs. Week 8|18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.|||units on a scale||Standard Deviation|Mean
1436148|NCT00963924|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)|Change of a composite score from baseline to week 8 on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). The MATRICS consists of 10 cognitive tasks that are used to calculate scores in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores on each cognitive task are transformed on a normative scale into t-scores, and then these scores are combined to calculate the domain scores. The composite score is calculated by averaging all domain t-scores to come up with one overall cognitive composite t-score. For all scores on the assessment, the higher the score the better the performance on the task.|Baseline vs. Week 8|18 participants in each arm had baseline values available for analysis. 17 in the D-cycloserine arm and 15 in the placebo arm had week 8 values available for analysis.|||t-scores||Standard Deviation|Mean
1436149|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
1436150|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
1436151|NCT00963872|Secondary|Donor Chimerism|Percentage of donor DNA in the bone marrow.|Day 100|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
1436152|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436153|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 720|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436154|NCT00963872|Secondary|Overall Survival at Day 720|Survival (alive) from transplantation to last follow-up at day 720.|720 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436155|NCT00963872|Secondary|Non-relapse Mortality|Deaths not due to relapse.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436156|NCT00963872|Secondary|Incidence of Grades III-IV Graft-vs-host Disease|Development of graft-versus-host disease by day 100.|0 to 100 days|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436157|NCT00963872|Secondary|Donor Chimerism in Blood|Percentage of donor DNA present in the peripheral blood|Day 60|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
1436158|NCT00963872|Secondary|Platelet Recovery|Number of patients with >20,000 platelets/uL by day 180|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436159|NCT00963872|Secondary|Disease Progression|Patients who developed disease progression after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436160|NCT00963872|Secondary|Relapse of Disease|Patients who developed disease relapse after transplantation.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436161|NCT00963872|Secondary|Chronic Graft-Versus-Host Disease|Patients who developed chronic graft-versus-host disease.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436162|NCT00963872|Secondary|Bone Marrow Chimerism|Percentage of donor DNA in the bone marrow.|Day 21|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||percentage of donor DNA||Standard Deviation|Mean
1436163|NCT00963872|Secondary|Overall Survival|Survival (alive) from transplantation to last follow-up.|Day 360|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436168|NCT00963872|Primary|Number of Patients With the Complement 3a (C3a) Unit Predominating|Efficacy of the pre-incubation of one of two umbilical cord blood (UCB) units with C3a as part of a unrelated donor double UCB nonmyeloablative transplantation in patients with high-risk hematological malignancies.|Day 180|Two patients were unevaluable - one, because 1 bag of cord blood broke leaving only 1 cord available, and one subject never received the C3a.|||participants|||Number
1436169|NCT00963859|Primary|Overall Percentage Median Yield|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.|3 months including surgery and post-operative period.||||Percentage of Nodes (Node Yield)|||Number
1436170|NCT00963859|Primary|Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved|The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.|3 months including surgery and post-operative period.||||Nodes (Node Yield)||Full Range|Median
1436171|NCT00963820|Primary|Neurotoxicity Grading|Neurotoxicity is graded using participant responses to 11 functional questions on a 5-point scale, where 0=Not at all and 4=Very much, using the Functional Assessment of Cancer Therapy/Gynecology Oncology Group - Neurotoxicity Questionnaire, Version 4.0(14). Neurotoxicity subscale is a sum of 11 reversed item scores where each original score is transformed as (4 - score). The highest possible score is 44, and a higher score indicates more neurotoxicity.|Cycle 1 Day 1 and End of Study (Up to 354 days)|Safety Population included all randomized participants who received study drug.|||score on a scale||Standard Deviation|Mean
1436172|NCT00963820|Secondary|Overall Response to Treatment With Ixazomib Citrate Based on Investigator's Evaluation Over Time|"Responses were based on International Myeloma Working Group Uniform Criteria. Complete Response (CR)=Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~Partial Response (PR)= reduction in M-Protein ≥50% in serum and ≥90% in 24-hour urine. If M-protein unmeasurable, ≥50% decrease in difference of involved and uninvolved Free Light Chain (FLC). If M-protein and FLC unmeasurable, ≥50% reduction in plasma cells is required, if baseline bone marrow plasma cell ≥30%. And ≥50% reduction in the size of soft tissue plasmacytomas.~Minimal Response (MR)= 25–49% reduction in serum paraprotein for 6 weeks. 50–89% reduction in 24 hour urinary light chain excretion for 6 weeks. For Non-secretory myeloma patients, 25–49 % reduction in plasma cells in bone marrow and trephine biopsy for a 6 weeks. 25–49% reduction in the size of soft tissue plasmacytomas. No increase in the size or number of lytic bone lesions."|Up to 354 days|Response-Evaluable Population included all participants who had measurable disease at Baseline, had received at least 1 dose of study drug, and had at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1436173|NCT00963820|Secondary|TEmax: Time of Occurrence of Emax||Days 1 and 15 of Cycle 1|PD analysis population included all participants who had sufficient dosing data to calculate PD parameters|||Hours||Standard Deviation|Mean
1436174|NCT00963820|Secondary|Emax: Maximum Inhibition|A Whole Blood 20S Proteasome Inhibition Parameter. There were no subjects in the Pharmacodynamic (PD) Analysis Set for the 2.23 mg/m^2 cohort, so PD tables do not include that arm.|Days 1 and 15 of Cycle 1|PD analysis Population included all participants who had sufficient dosing data to calculate PD parameters|||Percentage of inhibition||Standard Deviation|Mean
1436175|NCT00963820|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN2238|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal phase elimination half-life.|||hour||Standard Deviation|Mean
1436176|NCT00963820|Secondary|Terminal Elimination Rate Constant (λz) for MLN2238|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body and the values were used for calculation of T1/2. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of terminal elimination rate constant.|||1/hour||Standard Deviation|Mean
1436177|NCT00963820|Secondary|Accumulation Ratio: Day 15 AUC0-168 / Day 1 AUC0-168 for MLN2238|MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Day 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of accumulation ratio.|||unitless||Standard Deviation|Mean
1436178|NCT00963820|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for MLN2238|AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC[0-tau]), where tau is the length of the dosing interval - 168 hours in this study). MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of AUC(0-168).|||hr*ng/mL||Standard Deviation|Mean
1436179|NCT00963820|Secondary|Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for MLN2238|Tmax: Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the PK Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for analysis of Tmax.|||hours||Full Range|Median
1436180|NCT00963820|Secondary|Cmax: Maximum Observed Plasma Concentration for MLN2238|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. MLN2238 is the complete hydrolysis product of the study drug ixazomib citrate (MLN9708).|Days 1 and 15 of Cycle 1|Participants from the Pharmacokinetic (PK) Analysis Population, all participants who had sufficient dosing data to calculate PK parameters, with data available for calculation of Cmax.|||ng/mL||Standard Deviation|Mean
1436181|NCT00963820|Primary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events|"An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.~A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|From the first dose through 30 days after last dose of ixazomib citrate or until the start of subsequent antineoplastic therapy (Up to 354 days)|Safety Population included all randomized participants who received study drug.|||participants|||Number
1436182|NCT00963807|Secondary|Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)|RECIST version 1.1 was utilized for this outcome measure. A detailed description of RECIST 1.1 can be found here: Nishino M, Jackman DM, Hatabu H, Yeap BY, Cioffredi LA, Yap JT, et al. New Response Evaluation Criteria in Solid Tumors (RECIST) guidelines for advanced non-small cell lung cancer: comparison with original RECIST and impact on assessment of tumor response to targeted therapy. AJR Am J Roentgenol 2010;195:W221-8.|Up to 6 weeks||||percentage of participants|||Number
1436183|NCT00963807|Secondary|Change in 18F-Fluorodeoxyglucose (FDG) Uptake|Will be calculated by subtracting the baseline FDG uptake from the post-cycle 2 uptake (as measured by SULmax).|Baseline and 6 weeks||||SULmax||Standard Deviation|Mean
1436184|NCT00963807|Primary|Change in FLT Uptake in Responders and Non-responders|Unadjusted analysis will be performed utilizing students t-tests. If the data appears non-normal, the Wilcox on rank-sum test will be used rather than the t-test. Adjusted analysis will be performed utilizing logistic regression.|Baseline and 6 weeks||||SULmax||Standard Deviation|Mean
1436185|NCT00963807|Primary|Change in FLT Uptake|Will be calculated by subtracting the uptake of the scan after the second cycle of chemotherapy from the uptake of the pre-treatment scan.|Baseline and 6 weeks||||SULmax||Standard Deviation|Mean
1436186|NCT00963807|Primary|Change in 18F-Fluorothymidine (FLT) Uptake|Will be calculated by subtracting the uptake of the scan after the first cycle of chemotherapy from the uptake of the pre-treatment scan.. Change in FLT uptake will be measured using the maximum standard uptake value adjusted for lean body mass (SULmax), which is a measure of how much radiotracer (in this case FLT) is being consumed by cells.|Baseline and 3 weeks||||SULmax||Standard Deviation|Mean
1436187|NCT00963677|Secondary|Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet|The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.|1 hour (peri-intubation time)||||seconds||Standard Deviation|Mean
1436188|NCT00963677|Primary|Number of the Patients With Successful Nasotracheal Intubation|After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.|1 hour(peri-intubation time)||||participants|||Number
1436189|NCT00963638|Primary|Frequency/Duration of Muscle Cramps||30 days|||||||
1436190|NCT00963638|Primary|Change in Frequency of Leg Cramps|Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline).|30 days||||Cramps per week||Standard Deviation|Mean
1436191|NCT00963599|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436192|NCT00963599|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436193|NCT00963599|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1438507|NCT00946023|Secondary|Incidence of Grades III-IV Acute GVHD|Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
1436194|NCT00963599|Secondary|Mean Change From Baseline in Nasal Congestion Upon Awakening|Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436195|NCT00963599|Secondary|Mean Change From Baseline in Daytime Sneezing Score|Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436196|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Itching Score|Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436197|NCT00963599|Secondary|Mean Change From Baseline in Daytime Rhinorrhea Score|Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436198|NCT00963599|Secondary|Mean Change From Baseline in Daytime Nasal Congestion Score|Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436199|NCT00963599|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436200|NCT00963599|Secondary|Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)|Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436201|NCT00963599|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436202|NCT00963599|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436203|NCT00963560|Primary|Best Corrected Visual Acuity|Best corrected vision was tested at 4 meters (m), 60 centimeters (cm), 40cm and at preferred distance (distance chosen by each subject) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity. Preferred distance for each study group was as follows: ReSTOR +3 = 38.7 +/- 6.8 cm, Crystalens HD = 49.9 +/- 9.8 cm, Crystalens AO = 53.1 +/- 9.8 cm.|6 Months after surgery|2 ReSTOR +3 subjects and 1 Crystalens HD subject missed their final visits and were not included in this analysis.|||logMAR||Standard Deviation|Mean
1436204|NCT00963508|Secondary|Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).|"The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.~Treatment Success in the Efficacy ITT (LOCF)"|3 weeks|Proportion of subjects that are lice free 14 days after their first treatment|||percentage of subjects|||Number
1436205|NCT00963508|Primary|Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)|"The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)~Treatment Success in the Efficacy ITT (LOCF)~index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))"|3 weeks|Efficacy: index subjects who had at least one application of treatment mITT: treated subjects who had at least one post-treatment visit Subjects with missing efficacy data were included first LOCF and then with non-LOCF PP: subjects who complied with the protocol, completed all required visits Safety: all subjects who had at least one treatment|||percentage of subjects|||Number
1436206|NCT00963482|Secondary|Drinking in the Last 7 Days (Patients Report + Urine Sample)||6 months|||||||
1436207|NCT00963482|Primary|Number of Smoke-free Patients|"Smoke-free defined with following measures:~patients self-report about smoking in the last 7 days (yes/no)~CO-level (smoke-free <10ppm)~urine sample (cotinine)"|6 months|Intention-to-treat analysis|||participants|||Number
1436208|NCT00963469|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period|Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1436209|NCT00963469|Secondary|Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1436210|NCT00963469|Secondary|Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment|An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.|After first 2 weeks of treatment|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1436211|NCT00963469|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Eye Symptoms scores.~Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1436212|NCT00963469|Secondary|Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period|Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1436213|NCT00963469|Secondary|Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Nighttime Symptoms Score.~Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1436214|NCT00963469|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period|"Mean change from baseline in Daytime Nasal Symptoms Score.~Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score."|Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement through the first 2 weeks of treatment were included.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1436215|NCT00963430|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes, or was described as Guillain-Barré Syndrome. Association was determined by a clinician licensed to diagnose and listed on the site's FDA Form 1572.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the ITT safety cohort.|||Participants|||Number
1436216|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
1436217|NCT00963430|Primary|Number of Participants Reporting Neonatal Complications|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All live births are included in this outcome measure, which excludes 2 participants whose pregnancies ended in miscarriage or stillbirth. Three participants gave birth to twins and one to triplets, each counted separately.|||Participants|||Number
1436218|NCT00963430|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.|||Participants|||Number
1436219|NCT00963430|Primary|Number of Participants With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants at Day 21 post first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
1436220|NCT00963430|Primary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after the first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints, with 5 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
1436221|NCT00963430|Primary|Number of Participants Reporting Fever After Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436222|NCT00963430|Primary|Number of Participants Reporting Fever After First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 37.8 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 37.8 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436223|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436224|NCT00963430|Secondary|Number of Participants With 4-fold or Greater Serum Hemagglutination Inhibition (HAI) Antibody Titer Increases Against Influenza H1N1 2009 Virus Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations within 4 days of the window and had blood collected at both timepoints, with 13 participants excluded due to receipt of non-study vaccines. Participants were analyzed as treated.|||Participants|||Number
1436225|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in Cord Blood|Cord blood was collected at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if a cord blood sample was collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 5 due to specimen processing errors at the time of sample collection.|||Participants|||Number
1436226|NCT00963430|Secondary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against the Novel Influenza H1N1 2009 Virus in the Maternal Blood at the Time of Delivery|Blood was collected from participants at the time of delivery for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|At time of delivery|Participants were included in the analyses if they had blood collected at delivery, with 22 participants excluded due to receipt of non-study vaccines and 3 due to specimen processing errors at the time of sample collection. Participants were analyzed as treated.|||Participants|||Number
1436810|NCT00959049|Secondary|New Onset of Chronic Illnesses (NOCIs)|New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|6 months after last study vaccination|Safety population|||Participants|||Number
1436227|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436228|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436229|NCT00963430|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436230|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436231|NCT00963430|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436232|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1436233|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1436234|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever greater than or equal to [>=]38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours [hrs]); Moderate (>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (>=6 loose stools in 24 hrs). Report of fever >40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1436485|NCT00961662|Primary|Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus|The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).|6 months from baseline|ITT Population|||participants|||Number
1436235|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 3|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1436236|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 2|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1436237|NCT00963235|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]); Moderate (5.5 to 10.0 cm); Severe (greater than [>] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).|Within 14 days post-dose 1|Safety population:participants who received at least 1 dose of study vaccine. ‘N’(number of participants analyzed)=participants whose response was “Yes” for any day or “No” for all days. ‘n’ = participants whose response was “Yes” for any day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
1436238|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||fold rise||95% Confidence Interval|Geometric Mean
1436239|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||fold rise||95% Confidence Interval|Geometric Mean
1436240|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
1436241|NCT00963235|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
1436250|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
1436242|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.|1 month post-dose 1, 1 month post-dose 2|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||mcg/mL||95% Confidence Interval|Geometric Mean
1436243|NCT00963235|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1436244|NCT00963235|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC|Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.|1 month post-dose 2, 1 month post-dose 3|Evaluable immunogenicity population: eligible participants who were >=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.|||fold rise||95% Confidence Interval|Geometric Mean
1436245|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436246|NCT00963157|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436247|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436248|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the first vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to eligibility deviation. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436249|NCT00963157|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1436538|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436251|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1436252|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
1436253|NCT00963157|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
1436254|NCT00963157|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
1436255|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436256|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436257|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436258|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436267|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436259|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 270 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436260|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 180 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436261|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436262|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1436263|NCT00963157|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
1436264|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.|||Participants|||Number
1436265|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436266|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436268|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436269|NCT00963157|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436270|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 270 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436271|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 180 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436272|NCT00963157|Primary|Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.|||Participants|||Number
1436273|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after second vaccination|Participants who received at least the first vaccination and had blood collection at the timepoint are included. Analyses are as treated.|||Participants|||Number
1436274|NCT00963157|Primary|Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination|Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.|8-10 days after first vaccination|Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.|||Participants|||Number
1436275|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436276|NCT00963157|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8 after the second vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436277|NCT00963157|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 365 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1436278|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436279|NCT00963157|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to influenza-like illness. This outcome restricts to age stratum.|||Participants|||Number
1436280|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1436281|NCT00963157|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.|Day 0 prior to vaccination and 8 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to an eligibility deviation. This outcome restricts to age stratum.|||Participants|||Number
1436282|NCT00962949|Secondary|Cortisol Level||1 hour||||ng/ml/h||Standard Error|Mean
1436283|NCT00962949|Secondary|Aldosterone Level||1 hour||||picogram/milliliter||Standard Error|Mean
1436284|NCT00962949|Secondary|Plasma Renin Activity||1 hour||||micrograms/deciliter||Standard Error|Mean
1436285|NCT00962949|Primary|Mean Arterial Blood Pressure Change||1 hour||||mm/Hg||Standard Error|Mean
1436286|NCT00962871|Secondary|Early Changes in Viral Sequence Associated With Viral Suppression|Viral sequence data was obtained from the first 10 participants enrolled in Study but on analysis of the data, numerous low frequency deviations from the HBV consensus sequences were observed in the 454 SLX sequence data which were not replicated in data obtained from routine Sanger sequencing. These sequence deviations did not correspond to a temporal pattern consistent with selection of mutations following HBV treatment. Moreover, they could not be reliably distinguished from sequencing artifacts. It was also revealed that complete genome coverage was not obtained due to errors in the design of the primer sequences. For these reasons, further sequence analyses were not performed for the remaining treatment population.|Day 1, 5, 14, Week 4 and 6|||||||
1436287|NCT00962871|Secondary|Mean Change From Baseline in HBV-DNA log10|An acute virologic response was determined by change from baseline in HBV-DNA log10.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.|||IU/mL||Standard Deviation|Mean
1436288|NCT00962871|Primary|Mean Change From Baseline in Viral Quantitative e Antibody|An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.|Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)|All participants who received at least 1 dose of the study medication were included in this analysis. Only participants with both a baseline value and a value particular time point were summarized.|||Cut-off index (C.O.I.)||Standard Deviation|Mean
1436289|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 1 participant and all reporting of severe vomiting, after 13vPnC Dose 3, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1436290|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C and all reporting of severe vomiting, after 13vPnC Dose 2, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1436291|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius[C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). All reporting of fever >40 degrees C except 2 participants and all reporting of severe vomiting, after 13vPnC Dose 1, were confirmed as data entry errors.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any systemic event and “n” signifies participants with known values for specified systemic event. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1436292|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 3|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1436293|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).|Within 14 days after 13vPnC Dose 2|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1436335|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1436294|NCT00962780|Other Pre-specified|Percentage of Pediatric, Adult and All Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters (cm) for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than (>) 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Report of severe swelling was confirmed as data entry error.|Within 14 days after 13vPnC Dose 1|Safety population. Here “N” (number of participants analyzed) signifies participants with known values for any local reaction and “n” signifies participants with known values for specified local reaction. Participants may be represented in more than 1 category.|||percentage of participants|||Number
1436295|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
1436296|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a mcOPA assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||titers||95% Confidence Interval|Geometric Mean
1436297|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 23vPS Dose were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 3 and 1 month after 23vPS Dose blood draws.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
1436298|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 and 1 Month After 23vPS Dose in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both after 13vPnC Dose 3 and after 23vPS Dose blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 3, 1 month after 23vPS Dose|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 3 and after 23vPS Dose blood draws for each treatment arm, respectively."|||mcg/mL||95% Confidence Interval|Geometric Mean
1436299|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
1436539|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|Baseline|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436300|NCT00962780|Other Pre-specified|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||titers||95% Confidence Interval|Geometric Mean
1436301|NCT00962780|Other Pre-specified|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose and after 13vPnC Dose 1 blood draws.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
1436302|NCT00962780|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Before and 1 Month After 13vPnC Dose 1 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both the before and after 13vPnC Dose 1 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both the before and 1 month after 13vPnC Dose 1 blood draws for each treatment arm, respectively."|||mcg/mL||95% Confidence Interval|Geometric Mean
1436303|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
1436304|NCT00962780|Secondary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
1436305|NCT00962780|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of pediatric, adult and all participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMT were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies participants with valid and determinate assay results for specified serotype at both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws for each treatment arm, respectively."|||titers||95% Confidence Interval|Geometric Mean
1436588|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD|"DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436306|NCT00962780|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 Relative to 1 Month After 13vPnC Dose 2 in Pediatric, Adult and All Participants|Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|"Evaluable immunogenicity population. Here “N” (number of participants analyzed) signifies all participants who were evaluable for this measure and n signifies all participants who were evaluable for specified serotype for each treatment arm, respectively."|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1436307|NCT00962780|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 2 to 1 Month After 13vPnC Dose 3 in All Participants|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 2 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 2 and after 13vPnC Dose 3 blood draws.|1 month after 13vPnC Dose 2, 1 month after 13vPnC Dose 3|Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid, determinate assay result; had no major protocol violation. N (number of participants analyzed)=participants evaluable for this measure, n=participants evaluable for specified serotype.|||fold rise||95% Confidence Interval|Geometric Mean
1436308|NCT00962754|Secondary|Complications|notifications of complications|duration of admission||||participants|||Number
1436309|NCT00962754|Secondary|Use of Diuretics|prescription of diuretic therapy|during days of admission||||participants|||Number
1436310|NCT00962754|Primary|Duration of Admission at the Ward in Days|Duration of hospital stay in days or duration of admission at the pediatric ward in days|1-8 months|intention to treat analysis|||number of days||Full Range|Median
1436311|NCT00962741|Other Pre-specified|Number of Participants With Neutralizing Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1436312|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: PsA Sub-population||Baseline up to Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a firstdegree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1436313|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: ERA Sub-population||Baseline up to Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1436314|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population||Baseline up to Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1436315|NCT00962741|Other Pre-specified|Number of Participants With Anti-etanercept Antibodies||Baseline up to Week 12, Week 48, Week 96|Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1436316|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436317|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436336|NCT00962741|Other Pre-specified|Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population|PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436318|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436319|NCT00962741|Other Pre-specified|Body Mass Index (BMI) z-Score by Age Group|BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436320|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for PsA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436321|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for ERA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436322|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group for eoJIA Sub-population|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436323|NCT00962741|Other Pre-specified|Weight z-Scores by Age Group|Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436324|NCT00962741|Other Pre-specified|Height z-Score by Age Group for PsA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436325|NCT00962741|Other Pre-specified|Height z-Score by Age Group for ERA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436811|NCT00959049|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Events|30 days after each vaccination|Safety population|||Participants|||Number
1436326|NCT00962741|Other Pre-specified|Height z-Score by Age Group for eoJIA Sub-population|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|eoJIA sub-population: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436327|NCT00962741|Other Pre-specified|Height z-Score by Age Group|Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|Baseline, Week 12, Week 48, Week 72, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||z-score||Standard Deviation|Mean
1436328|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for PsA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436329|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for ERA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436330|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group for eoJIA Sub-population|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436331|NCT00962741|Other Pre-specified|Tanner Assessment Score by Age Group|Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).|Baseline, Week 12, Week 48, Week 96|Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436332|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): PsA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1436333|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): ERA Sub-population|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|ERA:participants with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen-B27;Ar in male>6yrs; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1436334|NCT00962741|Other Pre-specified|Number of Participants With Adverse Events (AEs): eoJIA Subpopulation|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.|Week 12, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Participants|||Number
1452604|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 06 from Baseline (i.e., between -45 days and +6 months)||||mg/dL||Standard Deviation|Mean
1436337|NCT00962741|Other Pre-specified|Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of BSA||Standard Deviation|Mean
1436338|NCT00962741|Other Pre-specified|Modified Schober's Test for ERA Sub-population|Modified Schober’s Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||cm||Standard Deviation|Mean
1436339|NCT00962741|Other Pre-specified|Nocturnal Back Pain Score for ERA Sub-population|Nocturnal back pain assessed by participant’s parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mm||Standard Deviation|Mean
1436340|NCT00962741|Other Pre-specified|Overall Back Pain Score for ERA Sub-population|Overall back pain assessed by participant’s parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mm||Standard Deviation|Mean
1436341|NCT00962741|Other Pre-specified|Tender Entheseal Assessment for ERA Sub-population|Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Tender entheses||Standard Deviation|Mean
1436342|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436343|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar /enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436344|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436345|NCT00962741|Secondary|Childhood Health Assessment Questionnaire (CHAQ) Score|CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants’s ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436346|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
1436347|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;humanleukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
1436348|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
1436349|NCT00962741|Secondary|Percentage of Participants With Inactive Disease Per Wallace 2004 Definition|Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants|||Number
1436350|NCT00962741|Secondary|Duration of Morning Stiffness: PsA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
1436351|NCT00962741|Secondary|Duration of Morning Stiffness: ERA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
1436352|NCT00962741|Secondary|Duration of Morning Stiffness: eoJIA Sub-population|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
1436353|NCT00962741|Secondary|Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Minutes||Standard Deviation|Mean
1436589|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD|"DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436354|NCT00962741|Secondary|Pain Assessment: PsA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436355|NCT00962741|Secondary|Pain Assessment: ERA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436356|NCT00962741|Secondary|Pain Assessment: eoJIA Sub-population|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436357|NCT00962741|Secondary|Pain Assessment|Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436358|NCT00962741|Secondary|C-reactive Protein (CRP): PsA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/L||Standard Deviation|Mean
1436359|NCT00962741|Secondary|C-reactive Protein (CRP): ERA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/L||Standard Deviation|Mean
1436360|NCT00962741|Secondary|C-reactive Protein (CRP): eoJIA Sub-population|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/L||Standard Deviation|Mean
1436361|NCT00962741|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||mg/Liter (mg/L)||Standard Deviation|Mean
1436362|NCT00962741|Secondary|Number of Joints With Limitation of Motion: PsA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436363|NCT00962741|Secondary|Number of Joints With Limitation of Motion: ERA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436590|NCT00960934|Primary|Percentage of Participants With Bone Neoplasms|"Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
1436364|NCT00962741|Secondary|Number of Joints With Limitation of Motion: eoJIA Sub-population|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436365|NCT00962741|Secondary|Number of Joints With Limitation of Motion|The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436366|NCT00962741|Secondary|Number of Active Joints: PsA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436367|NCT00962741|Secondary|Number of Active Joints: ERA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436368|NCT00962741|Secondary|Number of Active Joints: eoJIA Sub-population|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436369|NCT00962741|Secondary|Number of Active Joints|Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Joints||Standard Deviation|Mean
1436370|NCT00962741|Secondary|Patient/Parent Global Assessment: PsA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436371|NCT00962741|Secondary|Patient/Parent Global Assessment: ERA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436838|NCT00958789|Secondary|SF-36 Health Survey Change From Pre-op to Post-op Visits|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-op, 1, 2, 5 years|||||||
1436372|NCT00962741|Secondary|Patient/Parent Global Assessment: eoJIA Sub-population|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436373|NCT00962741|Secondary|Patient/Parent Global Assessment|Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436374|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436375|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436376|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436377|NCT00962741|Secondary|Physician's Global Assessment (PGA) of Disease Activity|PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Units on a scale||Standard Deviation|Mean
1436378|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436379|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436380|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436381|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 100 Response|ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436839|NCT00958789|Secondary|The Effect of Joint Line Restoration on Post-op Stability, Anterior Knee Pain & Functional Performance.||2 years, 5 years|||||||
1436382|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436383|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436384|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436385|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 90 Response|ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436386|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436387|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436388|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436389|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 70 Response|ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436443|NCT00962104|Secondary|Change From Baseline in the European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score up to 10 Weeks|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline EQ-5D result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436390|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436391|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436392|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436393|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 50 Response|ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436394|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436395|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|ERA:participants with arthritis(Ar) or(/)enthesitis,any 2:sacroiliac joint tenderness/inflammatory(Ifm)lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter’s syndrome history;human leukocyte antigen;Ar in male>6years;acute anterior uveitis(AAU)/AAU first-degree relative.|||Percentage of participants||95% Confidence Interval|Number
1436396|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436397|NCT00962741|Secondary|Percentage of Participants With an ACR Pedi 30 Response|ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96|mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).|||Percentage of participants||95% Confidence Interval|Number
1436479|NCT00961805|Primary|Visual Analog Scale for Pain|score between 0 and 100 where 0 is no pain and 100 in unbearable pain|baseline, after 16 weeks and after 32 weeks||||mm||Standard Deviation|Mean
1436480|NCT00961662|Secondary|Body Weight Loss (Compared to Baseline)||6 months|||||||
1436481|NCT00961662|Secondary|A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study||6 months|||||||
1436398|NCT00962741|Primary|Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12|ACR Pedi 30 response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.|Week 12|Modified Intent-to-Treat (mITT) population included all participants who received at least 1 dose of the study medication. Here ‘N’ (Number of participants analyzed) signified those participants who were evaluable for this measure at week 12.|||Percentage of participants||95% Confidence Interval|Number
1436399|NCT00962650|Primary|Completion of Diagnostic Peritineoscopy|"Number of participants in which transgastric access was achieved using the EES NOTES GEN1 Toolbox~Outcome description: Completion of diagnostic peritoneoscopy after transgastric access was completed using a flexible, steerable trocar. Because this was a feasibility trial, transgastric access was the primary outcome."|Assessed intra-operatively as the time from first insertion of the flexible trocar into the oral cavity to final withdrawal of the flexible trocar|The subject pool was limited to individuals scheduled for Rouen Y gastric bypass(Intent to Treat population). There was no statistical analysis. Success was based on completion of the diagnostic peritineoscopy procedure after transgastric access.|||Participants|||Number
1436400|NCT00962598|Primary|ACC GABA/Water|The ratio of gamma-Aminobutyric acid (GABA) and water in the brain (ratio divided by 10000 for analysis purposes), that was observed in MR Spectroscopy. GABA, an amino acid produced by cells of the central nervous system, is an inhibitory neurotransmitter, prominent in the human brain.|baseline and 10-weeks||||ratio * 10^-4||Standard Deviation|Mean
1436401|NCT00962598|Primary|ACC Glx/Water|The data reflects the ratio of Glutamine-Glutamate and water in the brain (ratio divided by 10000 for analysis purposes). Glutamate is a precursor to Glutamine, an amino acid which functions as an excitatory neurotransmitter in the human brain.|baseline and 10-weeks||||ratio * 10^-4||Standard Deviation|Mean
1436402|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined|"The following analysis pre-specified the combining of all S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) into a single treatment group. The results from the Wilcoxon-Mann-Whitney test (pair-wise test), based on the change from Baseline at Week 4, are presented.~Note: Dryness of Vagina was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)||||units on a scale||95% Confidence Interval|Mean
1436403|NCT00962585|Secondary|Mean Precentage Change in the Menopause Rating Scale Total Score From Baseline at Week 4|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: MRS consists of 11 symptoms, where each symptom is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Percentage Change||95% Confidence Interval|Mean
1436404|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined|"The following analysis shows the results when the S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) are combined and regarded as a single treatment group.~Note: Each MRS symptoms was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'"|4 weeks from Baseline (Day 0)||||units on a scale||95% Confidence Interval|Mean
1436405|NCT00962585|Post-Hoc|Percentage Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').|4 weeks from Baseline (Day 0)||||Percentage Change||95% Confidence Interval|Mean
1436406|NCT00962585|Post-Hoc|Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)|"Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').~Scores for Symptoms 5, 10, and 11 on the MRS were summed and analyzed. Total summed scores ranged from 0 to 12, with higher scores representing more severe symptoms."|4 weeks from Baseline (Day 0)||||units on a scale||95% Confidence Interval|Mean
1436407|NCT00962585|Secondary|Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4|"MRS consists of 11 menopause symptoms. The scoring scheme is simple, i.e., the score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items (severity 0 [no complaints] 4 scoring points [extremely severe symptoms]). The respondent provides her personal perception by checking one of 5 possible boxes of severity for each of the items. The composite score (total score) is the sum of the 11 item scores, which can range from 0 (no symptoms) to 44 (extremely severe symptoms). Low total scores represent less severe menopause symptoms while higher scores represent more severe symptoms."|4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||units on a scale||95% Confidence Interval|Mean
1436408|NCT00962585|Secondary|Change From Baseline in Progesterone Concentration at Week 2 and Week 4|No repeated measures ANCOVA results are presented for change from Baseline in progesterone concentrations since the model did not converge.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Progesterone Concentration (nmol/L)||95% Confidence Interval|Mean
1436409|NCT00962585|Secondary|Change From Baseline in Estradiol Concentration at Weeks 2 and 4|The LSMeans refer to overall adjusted mean estradiol concentration.|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Estradiol Concentration (pmol/L)||95% Confidence Interval|Mean
1436482|NCT00961662|Secondary|A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study||8 months|||||||
1436410|NCT00962585|Secondary|Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4|"The Vaginal Maturation Index was calculated by examining the maturation of the vaginal epithelium as adjudged by the cell types exfoliated. Parabasal cells are the least mature cells, intermediate cells display mild maturation, and superficial cells display the most maturity. The cell count is expressed as a percentage. The Vaginal Maturation Index was calculated as: 0.2*(parabasal cells, %)+0.6*(intermediate cells, %)+1.0*(superficial cells, %). This method is described in Menopause 2005;12(6):708-15.~The index serves as an objective means of evaluating hormonal secretion or response; lower values indicate more immature cells on the surface (atrophy), while higher values indicate more mature epithelium.~The LSMeans refer to overall adjusted mean percent of cells counted."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||percentage of cells||95% Confidence Interval|Mean
1436411|NCT00962585|Secondary|Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4|"The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. The pH scale is logarithmic and as a result, each whole pH value below 7 is ten times more acidic than the next higher value.~Normal vaginal pH is 3.8 to 4.5, slightly acidic.~The LSMeans refer to overall adjusted mean pH."|2 and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||units on a scale||95% Confidence Interval|Mean
1436412|NCT00962585|Secondary|Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4|"The severity of vasomotor symptoms per week at each of the protocol visits was calculated for each patient as follows: [(Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date – Previous protocol visit date (days)] * 7, where severity of vasomotor symptoms were scored as: 1 = mild, 2 = moderate and 3 = severe. Higher values represented worse severity.~LSMeans refer to the overall adjusted mean severity of VMS.~Hot Flush Classification: Mild: sensation of heat without sweating; Moderate: sensation of heat with sweating, able to continue activity; Severe: sensation of heat with sweating, causing cessation of activity.~Patients recorded the number of hot flushes (day and night) in their diaries related to the severity (mild/moderate/severe)."|1, 2, and 4 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||units on a scale||95% Confidence Interval|Mean
1436413|NCT00962585|Secondary|Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2|"The frequency of MSVS per week, at each of the protocol visits, was calculated as follows, for each patient: [# of Moderate+Severe hot flushes)/(Current protocol visit date–Previous protocol visit date (days)] * 7.~The ANCOVA procedure tested the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp, where μ1 and μp denote the mean frequency of MSVS, adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively.~LSMeans refer to the overall adjusted mean frequecy of MSVS."|1 and 2 weeks from Baseline (Day 0)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Number of MSVS/week||95% Confidence Interval|Mean
1436414|NCT00962585|Secondary|Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period)|"Change from Baseline in the frequency of MSVS (difference between Baseline [period following first 7 days of 2-week run-in period] and period following first 7 days of 2-week Week 4 period), where the Baseline MSVS frequency was captured at visit 3 (Day 0), in the period following the first 7 days, as per CRF. Note: this endpoint is identical to the primary endpoint, however, instead of a 14 ± 2 day period, the period following the first 7 days was used, at Baseline and visit 3.~Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (period following first 7 days of 2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Number of MSVS/week||95% Confidence Interval|Mean
1436415|NCT00962585|Primary|Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period)|"The primary efficacy endpoint for this study was the change from Baseline (Day 0) in the frequency of MSVS (difference between Baseline [2-week run-in period] and Week 4), where the baseline MSVS frequency was captured over 14 ± 2 day period. Moderate is defined as “sensation of heat with sweating, able to continue activity”; severe is defined as “sensation of heat with sweating, causing cessation of activity”. Patients used the take-home daily diary to record MSVS information during the run-in period and treatment period and analyses were performed as specified.~Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS."|4 weeks from Baseline (2-week run-in period)|The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.|||Number of MSVS/2 weeks||95% Confidence Interval|Mean
1436416|NCT00962390|Secondary|Change in DAN Prostate Symptom Scale From Baseline at Week 4|The questionnaire is made up of two kinds of questions: intensity of a symptom and bothersomeness of a symptom. Prostate symptoms are addressed in questions 1 - 12 and sexual function in questions 13 - 15. Patients indicate how intense/frequent (scoring 0, 1, 2, or 3; where 0 represents the best case and 3 the worst case) and how bothersome the symptom (scoring 0, 1, 2, or 3; where 0 is 'not at all' and 3 is 'very much'). DAN-PSS total and DAN-PSS total sexual function score were calculated by multiplying the frequency score by the trouble score of each symptom, and then adding the resulting figures. The possible values of DAN-PSS total ranged from 0 to 108 and of DAN-PSS total sexual function score ranged from 0 to 27. A reduction in DAN-PSS total and/or sexual function score is consistent with improved BPH symptoms/sexual functioning.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||units on a scale||Standard Deviation|Mean
1436417|NCT00962390|Secondary|Change in I-PSS Total Score From Baseline at Week 4|The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of 6 answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The first seven questions of the I-PSS are identical to the questions appearing on the American Urological Association (AUA) Symptom Index which currently categorizes symptoms as follows: Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); and Severe (symptom score range 20-35). A reduction in I-PSS Total Score is consistent with improvement in symptoms of BPH.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||units on a scale||Standard Deviation|Mean
1436418|NCT00962390|Secondary|Investigators Assessment of Nocturia at Week 4|Investigators were asked to rate participant's change in nocturia since the Baseline Visit.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||number of times urinated at night||Full Range|Median
1436419|NCT00962390|Secondary|Participants Assessment of Nocturia at Week 4|Participants were asked to rate their change in nocturia (number of times you wake from sleep to urinate) since the Baseline Visit.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||number of times to urinate at night||Full Range|Median
1436420|NCT00962390|Secondary|Change in Total Testosterone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||nmol/L||Standard Deviation|Mean
1436421|NCT00962390|Secondary|Change in Luteinizing Hormone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||IU/L||Standard Deviation|Mean
1436422|NCT00962390|Secondary|Change in in Dihydrotestosterone Concentration From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||pg/mL||Standard Deviation|Mean
1436423|NCT00962390|Secondary|Change in Post-Void Residual Volume From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL||Standard Deviation|Mean
1436424|NCT00962390|Secondary|Change in Void Volume From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL||Standard Deviation|Mean
1436425|NCT00962390|Secondary|Percent Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||Participants|||Count of Participants
1436426|NCT00962390|Secondary|Categorical Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||Participants|||Count of Participants
1436427|NCT00962390|Secondary|Change in Qmax From Baseline at Week 4||4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL/sec||Standard Deviation|Mean
1436428|NCT00962390|Secondary|Change in Prostate Volume From Baseline at Week 4|Prostate size as measured by prostate volume as assessed by transrectal ultrasound.|4 weeks|All randomized subjects who received at least 1 dose of investigational product starting at Baseline, and who had at least 1 post-dose assessment of interest.|||mL||Standard Deviation|Mean
1436429|NCT00962390|Primary|Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.|Prostate specific antigen is considered to be the most sensitive measure of S-equol effects on the prostate, due to the expected effects of S-equol on the androgen receptor axis. In this proof-of-concept study, a population of 124 male subjects was estimated to achieve approximately 104 completed subjects (based on an estimated drop-out rate of 15%) to examine the dose-response compared to placebo. A sample size of 26 subjects in each treatment arm was considered to be adequate to observe a trend in this proof-of-concept study.|4 weeks|All Participants who received at least 1 dose of study drug and who had a post-dose PSA assessment at Week 4.|||ng/mL||Standard Error|Least Squares Mean
1436430|NCT00962247|Secondary|Energy Intake|Resting metabolic rate was calculated using the activity data from accelerometer (Actigraph) collection. Resting metabolic rate was used to calculate estimated daily energy expenditure. Daily energy expenditure and weight change over the study period was used to estimate energy intake. If weight was stable of the nine weeks, assume energy intake = energy expenditure. A gain of a pound was estimated as equivalent to a positive balance of 3500 calories and a loss of a pound was estimated as equivalent to a negative balance of 3500 calories.|3 days||||calories/day||Standard Error|Mean
1436431|NCT00962247|Primary|Physical Activity|Actigraph activity monitors were used to record physical activity over 3 days, in addition to a weekly physical activity diary. Acti-graph counts were used to estimate energy expenditure during waking hours. Counts per minute describes the average rate of counts, with 0 being at rest and higher numbers indicating more vigorous physical activity.|3 days||||counts/minute of physical activity||Standard Error|Mean
1436432|NCT00962208|Secondary|Determine Changes in Other Ocular Parameters (e.g. Corneal Biomechanics and Aberration) Associated With Orthokeratology Lens Wear||2 years|||||||
1436433|NCT00962208|Secondary|Determine the Incidence of Adverse Effects in Cornea, the Palpebral, Bulbar and Tarsal Conjunctiva in the Study and the Control Groups||2 years|||||||
1436434|NCT00962208|Primary|Axial Elongation in the Study and Control Subjects Who Completed the Two Years Study|Axial elongation was determined by the change in axial length of the eyeball before and after treatment period. Axial length was measured by the IOLMaster (Zeiss Humphrey, Dublin, CA) 30 minutes after cycloplegia. The measurement of the axial length followed the procedures as recommended by the manufacturer.|2 years||||mm||Standard Deviation|Mean
1436435|NCT00962104|Secondary|Change From Baseline in the Hamilton Depression Rating Scale-17 Items (HAMD-17 Total) up to 10 Weeks|The HAMD-17 was used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present) to 4 (very severe) or a 3-point scale of 0 (not present) to 2 (marked). Higher scores indicate greater symptom severity. The total score is the sum of the scores from HAMD-17 Items 1 through 17. The total score may range from 0 (not at all depressed) to 52 (severely depressed). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMD-17 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436436|NCT00962104|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale-14 Items (HAMA-14) up to 10 Weeks|Clinician-administered rating scale that assesses severity of anxiety and its improvement (or change) during course of treatment (Hamilton 1959; Riskind et al. 1987). Scale consists of 14 items that provide an overall measure of general anxiety, including psychic anxiety and somatic anxiety. Investigator talked to participant about participant's symptoms over previous week before study visit. Each item is rated on a 5-point scale of 0 (absent) to 4 (very severe). Total score=sum of 14 items and ranges from 0 (normal) to 56 (severe). Higher scores indicate a greater degree of symptom severity.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline HAMA-14 result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436437|NCT00962104|Secondary|Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) up to 10 Weeks|The CGI-ADHD-I is a single-item clinician rating of the clinician’s assessment of the participant’s improvement in ADHD symptoms in relation to the clinician’s total experience with ADHD participants. Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment (1=very much improved to 7=very much worsened).|Up to 10 weeks|All randomized participants with an endpoint CGI-ADHD-I value within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436438|NCT00962104|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit/Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) up to 10 Weeks|The CGI-ADHD-S is a single-item clinician rating of the clinician’s assessment of the overall severity of the participant’s ADHD symptoms in relation to the clinician’s total experience with ADHD participants. Measures severity of the participant's overall severity of ADHD symptoms (1=normal, not at all ill to 7=among the most extremely ill participants).|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CGI-ADHD-S result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436439|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Informant (BRIEF-A: Informant) Score up to 10 Weeks|Third-party observer of participant completes 75-item scale. Comprised of 3 subscales. Each item rated on 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75-225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436440|NCT00962104|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Score up to 10 Weeks|A 75-item standardized self-reported measure comprised of 3 subscales. Each item is rated on a 3-point Likert scale (1=behavior never observed to 3=behavior often observed). Behavioral regulation subscale measures one’s control over behavior (30-90 total score). Metacognition subscale assesses systematic problem-solving ability while sustaining these task-completion efforts in active working memory (40-120 total score). Global executive composite (GEC) subscale rates participant’s GEC in everyday environment (75- 225 total score). Higher subscale ratings=greater perceived impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline BRIEF-A result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436441|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report: Screening Version (CAARS-S:SV) 18 Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|Participant assessment of symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-S:SV result were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1436442|NCT00962104|Secondary|The Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score at 10 Weeks|CAARS-Inv:SV assesses symptom severity over past week. Total ADHD symptom score comprises 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently). Total score range: 0 to 54. Higher scores=greater impairment. Least Squares Mean Value based on mixed model repeated measures analysis with term for baseline, country, visit, treatment, and treatment*visit. Baseline included as a covariate; thus, treatment difference in observed value is same as change from baseline.|10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1436483|NCT00961662|Secondary|A Decrease of ≥0.5% in HbA1c Level at Each Study Visit||6 months|||||||
1436444|NCT00962104|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life-29 (AAQoL) Scores up to 10 Weeks|Participant-reported outcome measure used to examine disease-specific functional impairments and QoL for adults with ADHD. The domains include work functioning, family relationships, social functioning, activities of daily living (that is, driving, managing finances), and psychological adaptation (that is, life satisfaction and self-esteem). Individual items scored on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). Range of scores for this subscale is 0 to 100. Consistent with the majority of existing QoL measures, higher scores on AAQoL-29 indicate better functioning.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline AAQoL result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436445|NCT00962104|Primary|Change From Baseline in the Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-Item Total Attention-Deficit/Hyperactivity Disorder (ADHD) Symptom Score up to 10 Weeks|CAARS-Inv:SV is a scale that assesses symptom severity over past week. Total ADHD symptom score consisted of 18 items (sum of inattention [9 items, range: 0-27] and hyperactivity-impulsivity [9 items, range: 0-27] subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54. Higher scores indicate greater impairment.|Baseline, up to 10 weeks|All randomized participants with a baseline and at least 1 post-baseline CAARS-Inv:SV result within each treatment group, last observation carried forward (LOCF) were included in the analysis.|||units on a scale||Standard Deviation|Mean
1436446|NCT00962065|Secondary|Change From Baseline at Day 28 in Triglycerides||Baseline to Day 28||||mg/dL||95% Confidence Interval|Mean
1436447|NCT00962065|Secondary|Change From Baseline at Day 28 in Mean Arterial Pressure||Baseline to Day 28||||mm Hg||95% Confidence Interval|Mean
1436448|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma Fructosamine Level||Baseline to Day 28||||µmol/L||95% Confidence Interval|Mean
1436449|NCT00962065|Secondary|Change From Baseline at Day 28 in Plasma HbA1c||Baseline to Day 28||||Percent||95% Confidence Interval|Mean
1436450|NCT00962065|Secondary|Change From Baseline at Day 29 in Fasting Plasma Glucose||Baseline to Day 29||||mg/dL||95% Confidence Interval|Mean
1436451|NCT00962065|Primary|Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion|To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.|Baseline to Day 28||||grams||95% Confidence Interval|Mean
1436452|NCT00962013|Secondary|Post-surgery Femoral Crack/Fracture and Subsidence Rate||Post-op to 5 years|Post-surgery femoral crack/fracture and subsidence rate were assessed by hip.|||percentage of hips|hips||Number
1436453|NCT00962013|Primary|Femoral Stem Fracture||5 years|Participants who received the Restoration Modular Hip System.|||femoral stem fractures|||Number
1436454|NCT00962013|Secondary|SF-36 Health Status Survey: Role - Physical|"Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state:~The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health~This Secondary Outcome Measure is focused on the Role-Physical score."|pre-op, 2 year and 5 year|SF-36 Scores were assessed for each hip. (One hip did not have a pre-operative SF-36)|||units on a scale|hips|Standard Deviation|Mean
1436455|NCT00962013|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|pre-op and 5 years||||units on a scale|hips|Standard Deviation|Mean
1436456|NCT00962013|Secondary|Radiographic Stability|Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.|5 years|41 hips had fully evaluable radiographs at the 5 year interval; 40 out of the 41 hips are stable.|||percentage of stable hips|hips|95% Confidence Interval|Number
1436457|NCT00962013|Primary|Stem Survivorship (%)|Failure is defined by stem revision for any cause.|5 years|Participants with 5 year follow-up evaluations or participant had a stem revision before they reached 5 years.|||stem survivorship percentage at 5 years|hips|90% Confidence Interval|Number
1436458|NCT00962000|Secondary|Kt/V Determined From Measurements of Ionic Dialysance|Kt/VID was determined for all study treatments at 2 of the 3 centers using on-line clearance measurements (Gambro Diascan or Fresenius On-line Clearance Monitor).|4 weeks||||Kt/VID|Treatments|Standard Deviation|Mean
1436459|NCT00962000|Secondary|Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. The formula for equilibrated Kt/Vurea takes urea rebound into consideration. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA).|4 weeks||||equilibrated Kt/Vurea (eKt/V)|Treatments|Standard Deviation|Mean
1436460|NCT00962000|Primary|Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.|"The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the single-pool Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA)."|4 weeks||||single-pool Kt/Vurea (spKt/V)|Treatments|Standard Deviation|Mean
1436461|NCT00961896|Primary|Number of Participants With at Least Partial Clinical Clearance (Part I)|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|day 8, day 15, day 22, day 29|All part I participants were included in the analysis.|||Number of participants|||Number
1436484|NCT00961662|Secondary|Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit||6 months|||||||
1436462|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part II)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.|||Percent change in tumor measurement|Participants|Standard Deviation|Mean
1436463|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (by Tumor) (Part I)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks|All part I participants were included in this analysis.|||Percent change in tumor measurement|Participants|Standard Deviation|Mean
1436464|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part II)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated.. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks, 6 weeks, 9 weeks|Part II participants with evaluable data (n=3,6) were included in the analysis.|||percent change in tumor measurement||Standard Deviation|Mean
1436465|NCT00961896|Secondary|Change From Baseline in Tumor Measurements (Part I)|Measurement of the tumor size, volume and color by standardized digital photography, using dermatoscopic, macroscopic and 3D images of the BCCs was done by participant where if a participant had more than one tumor, for each of these tumors, the change from baseline was calculated (% change). From these values, the mean was calculated to get only one result per participant. Then for all the participants (n=8 both for LDE and vehicle), the mean was calculated. Photographic analysis was conducted by QuantifiCare. The volume of a lesion was measured with a special device, the “3D LIFEVIZ Micro system”, which uses a lens splitter to produce two images of the skin surface, captured at the same time, with viewing angle differences close to human vision. A stereovision algorithm is then applied to reconstruct and quantitatively analyze the skin surface in 3D. A negative change from baseline indicates improvement.|4 weeks|All part I participants were included in the analysis.|||Percent change in tumor measurement||Standard Deviation|Mean
1436466|NCT00961896|Primary|Percentage of BCCs With Complete and at Least Partial Clinical Clearance|Clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).|4 weeks, 6 weeks, 9 weeks|All participants were analyzed.|||Percentage of BCCs|Participants||Number
1436467|NCT00961805|Secondary|Self-image - Body Dysmorphic Disorder Examination Questionnaire|scored between 0 from 168, with higher scores indicating greater level of dissatisfaction with self-image|Baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436468|NCT00961805|Secondary|Depression - Beck Inventory|score between 0 from 63, with higher score indicating greater depression|Baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436469|NCT00961805|Secondary|Quality of Life - SF-36 - Mental Health|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436470|NCT00961805|Secondary|Quality of Life - SF-36 - Emotional Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436471|NCT00961805|Secondary|Quality of Life - SF-36 - Social Aspects|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436472|NCT00961805|Secondary|Quality of Life - SF-36 - Vitality|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436473|NCT00961805|Secondary|Quality of Life - Sf-36 - General Health State|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436474|NCT00961805|Secondary|Quality of Life - Sf-36 - Pain|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436475|NCT00961805|Secondary|Quality of Life - SF-36 - Physical Limitation|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436476|NCT00961805|Secondary|Quality of Life - SF-36 -Functional Capacity|score between 0 from 100, with higher scores denoting better quality of life|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436477|NCT00961805|Secondary|Quality of Life - Fibromyalgia Impact Questionnaire|score between 0 from 10 with 0 indicating no impairment and 10 indicating maximum impairment|baseline, after 16 weeks and after 32 weeks||||units on a scale||Standard Deviation|Mean
1436478|NCT00961805|Secondary|Function - 6 Minute Walk Test|meters traveled on a 20-meter course over a six-minute period|baseline, after 16 weeks and after 32 weeks||||meters||Standard Deviation|Mean
1436486|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.|Baseline, Week 6|PP: All subjects who received study drug, satisfied inclusion/exclusion criteria, and had at least 1 scheduled on-therapy visit. Individual subject visits or data points were excluded if protocol criteria were violated at a subset of the subject's visits and the violations, in the opinion of the Medical Monitor, did not invalidate remaining visits.|||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
1436487|NCT00961649|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim|The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).|Baseline, Week 6|ITT: All subjects who received study drug and had at least 1 scheduled on-therapy study visit.|||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
1436488|NCT00961636|Secondary|Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).|||Participants|||Number
1436489|NCT00961636|Primary|Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period|Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week.|Week 21 to Week 32|Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32).|||Participants|||Number
1436490|NCT00961571|Primary|Progression-free Survival|Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.|36 months|Progression-free survival (PFS) will be measured as the number of months between each patient's enrollment and his/her date of progression or date of death.|||months||Full Range|Median
1436491|NCT00961532|Secondary|Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)|We prospectively defined acute adverse events as: new fever >=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP < 100 mm Hg or new vasopressor use or increase in vasopressor dose by >25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.|within 6 hours of study treatment||||participants|||Number
1436492|NCT00961532|Primary|Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment|The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.|60 minutes after treatment start||||seconds||Standard Error|Mean
1436493|NCT00961441|Secondary|Occurrence of Treatment-Emergent Adverse Events From Starting Study Drug Treatment (Day 1) to up to 14 Days|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Treatment emergent means that an AE has begun or got worse after start of Keppra XR administration.|From Starting Study Drug Treatment (Day 1) to up to 14 days|Safety Set includes all subjects who took at least one dose of study medication. The Safety Set is identical to the Intention-to-treat (ITT) population in this study.|||Count|||Number
1436494|NCT00961441|Primary|Apparent Total Body Clearance (CL/F) of Keppra XR During up to 7 Days of Administration|The Apparent Total Body Clearance (CL/F) was calculated as Dose/ AUCtau. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population|||L/h||Geometric Coefficient of Variation|Geometric Mean
1436495|NCT00961441|Primary|Time of Maximum Plasma Concentration (Tmax) of Keppra XR During up to 7 Days of Administration|The Tmax is the time corresponding to the maximum plasma concentration of Keppra XR. It was directly obtained from the observed concentration versus time curve. 6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|PK-PP population|||hours (h)||Full Range|Median
1436496|NCT00961441|Primary|Area Under the Plasma Concentration Curve Over a Dosing Interval of 24 Hours (AUCtau) of Keppra XR Normalized by Dose, and by Body Weight and Dose During up to 7 Days of Administration|"AUCtau normalized by 1000 mg dose was calculated as:~AUCtau/(mg dose taken/ 1000 mg Keppra XR).~AUCtau normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~AUCtau/(bodyweight (kg)/ mg dose Keppra XR taken).~6 PK samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration. At steady state, reached after 2 days of administration of Keppra XR, the concentrations at 24h postdose is equal to the predose concentration. The predose concentration was used as the 24h concentration to calculate AUCτau."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population|||µg*h/mL||95% Confidence Interval|Geometric Mean
1436497|NCT00961441|Primary|Maximum Concentration at Steady State (Cmax) of Keppra XR Normalized by Dose and by Body Weight and Dose During up to 7 Days of Administration|"The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose.~Cmax normalized by 1000 mg dose was calculated as:~Cmax/(mg dose taken/ 1000 mg Keppra XR).~Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as:~Cmax/(bodyweight (kg)/ mg dose Keppra XR taken).~Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration."|6 pharmacokinetic samples were taken pre-dose, 1, 2.5, 4, 6 and 10 hours after administration, at Day 4, 5, 6, or 7 of Keppra XR administration.|Pharmacokinetic Per-Protocol (PK-PP) population|||µg/mL||95% Confidence Interval|Geometric Mean
1436498|NCT00961415|Secondary|Quality of Life|European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire–Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire–Lung Cancer 13 [EORTC QLQ-LC13]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles.|Up to 21 months|The ITT population included all the participants that were randomized.|||Score on scale||Standard Deviation|Mean
1436499|NCT00961415|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10^9/L), for White blood cells (WBC) was 3.0-18.0 (10^9/L), for Lymphocytes was 0.70-7.60 (10^9/L), and Neutrophil 1.50-9.25 (10^9/L ).|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.|||Participants|||Number
1436500|NCT00961415|Secondary|Incidence of Adverse Events and Serious Adverse Event|An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Up to 21 months|The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.|||Participants|||Number
1436501|NCT00961415|Secondary|Duration of Disease Control During Maintenance Treatment Phase|Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.|||Months||95% Confidence Interval|Median
1436502|NCT00961415|Secondary|Duration of Response During Maintenance Treatment Phase|Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.Participants available at particular time point for assessment were included in the analysis.|||Months||95% Confidence Interval|Median
1436503|NCT00961415|Secondary|Best Overall Response Rate During Maintenance Treatment Phase|The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population which included all the participants that were randomized.|||percentage of participants||95% Confidence Interval|Number
1436504|NCT00961415|Secondary|Overall Survival During Maintenance Treatment Phase|Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.|||Months||95% Confidence Interval|Median
1452605|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 05 from Baseline (i.e., between -45 days and +12 weeks)||||mg/dL||Standard Deviation|Mean
1436505|NCT00961415|Primary|Progression Free Survival During Maintenance Treatment Phase|Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.|Up to 21 months|The ITT population included all the participants that were randomized.|||Months||95% Confidence Interval|Median
1436506|NCT00961402|Secondary|PHQ-9|Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression|6 Months||||Score on a scale||Standard Deviation|Mean
1436507|NCT00961402|Secondary|Edinburgh Postnatal Depression Scale|This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression.|6 Months||||Score on a scale||Standard Deviation|Mean
1436508|NCT00961402|Secondary|7-Day Physical Activity Recall Interview|Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run).|6 months||||Number of physical activity minutes||Standard Deviation|Mean
1436509|NCT00961402|Primary|Structured Clinical Interview for DSM-IV Axis I Disorders|This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression.|6 months||||percentage of participants|||Number
1436510|NCT00961350|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 Months|Intent to Treat (ITT) Population|||participants|||Number
1436511|NCT00961350|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population|||participants|||Number
1436512|NCT00961350|Secondary|The Number of Subjects With “Treatment Success”|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 Months|Intent to Treat Population|||participants|||Number
1436513|NCT00961350|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 Months|Intent to Treat (ITT) Population|||participants|||Number
1436514|NCT00961350|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||participants|||Number
1436515|NCT00961311|Secondary|Device Success|Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow.|1-3 days||||Percent of Participants|||Number
1436516|NCT00961311|Secondary|Vessel Perforation (Clinical)|Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.|1-3 days||||Percent of Participants|||Number
1436517|NCT00961311|Secondary|Major Adverse Cardic Events (MACE)|Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.|1-3 days||||Percent of Participants|||Number
1436518|NCT00961311|Primary|Procedural Success|Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.|1-3 days||||Percent of Participants|||Number
1436519|NCT00961298|Secondary|Irritable Bowel Syndrome Severity Scoring System|This is a 4 item Likert scale with each assessment being 100 mm scored from measuring from 0 to 400. Higher numbers indicate worse outcome.|endpoint [12 weeks]||||scores on a scale||Standard Deviation|Mean
1436520|NCT00961298|Secondary|Irritable Bowel Syndrome-Quality of Life Scale|"The IBS-QOL consists of 34 items, each with a five-point response scale. Ratings range from 1 not at all to 5 extremely or a great deal Higher responses on the scale indicate worse outcome. A minimal total score would be 34, maximum 170."|endpoint [12 weeks]||||scores on a scale||Standard Deviation|Mean
1436521|NCT00961298|Secondary|Hamilton Anxiety Rating Scale|"The HAM-A is a 14 question scale with five responses. Responses range from 0 not present to 4 very severe. The total score ranges from 0 to 56. Higher values represent a worse outcome."|endpoint [12 weeks]||||scores on a scale||Standard Deviation|Mean
1436522|NCT00961298|Primary|Clinical Global Impression Scale|"The scale consists of two parts the first part being Severity of Illness and the second part is Global Improvement. We report the Global improvement scale.~The Global Improvement is a 1-7 change scale of global improvement since inclusion in the project ranging with 1 very much improved, 4 no change, and 7 very much worse."|endpoint [12 weeks]|per protocol|||scores on a scale||Standard Deviation|Mean
1437104|NCT00957671|Secondary|Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|baseline|This data is for the 10 male subjects enrolled in this study.|||percent of body fat||Standard Deviation|Mean
1436523|NCT00961259|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.|||ng-hr/mL||Standard Deviation|Mean
1436524|NCT00961259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the [AUC(0-t)] values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.|||ng-hr/mL||Standard Deviation|Mean
1436525|NCT00961259|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.|||ng/mL||Standard Deviation|Mean
1436526|NCT00961233|Primary|Tissue Eosinophil Counts|Level of tissue eosinophil counts (measured in number of eosinophils per high-power microscopy field) on esophageal biopsy after treatment|8 weeks||||# of eosinophils per high-power field||Standard Deviation|Mean
1436527|NCT00961233|Secondary|Adrenal Insufficiency|Adrenal insufficiency as measured by a standard cortisol stimulation test (using 0.25 mg cosyntropin IV and baseline and 60 minute post-injection serum cortisol measurements) after treatment. A rise in serum cortisol concentration after to a peak of ≥18 mcg/dL was considered normal; a smaller rise than this was considered adrenal insufficiency.|8 weeks||||participants|||Number
1436528|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After seventh course at 14 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436529|NCT00961220|Secondary|Changes in AGT Inactivation in Non-responding Patients|Changes in AGT levels will be determined by biochemical activity assay from first course to seventh course of treatment.|After first course at 2 weeks|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436530|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436531|NCT00961220|Secondary|Changes in DNA Damage- Cytotoxicity|Immunohistochemistry will be used to assess expression of these proteins in keratinocytes, epidermal lymphocytes, and dermal lymphocytes, to determine the effects of BCNU cytotoxicity in each subpopulation of cells|24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436532|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436533|NCT00961220|Secondary|Changes in the Cell Cycle/Proliferation|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The proliferation rate will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436534|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 48 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436535|NCT00961220|Secondary|Changes in the Apoptosis|Comparing skin biopsy specimens of BCNU-protected CTCL lesional specimens vs BCNU-treated lesional specimens at 24 hours, using immunohistochemical staining for Ki-67, PCNA, bcl-2, and caspase-3, as well as y2HAX and TUNEL assays. The apoptotic index will be calculated from these results.|at 24 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436536|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|1 week after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436537|NCT00961220|Secondary|Changes in AGT (O6-alkylguanine DNA Alkyltransferase) Activity|Examine AGT depletion at baseline, 24 hrs or 48 hrs, and 1 week after the first Infusion of O6BG. AGT levels will be determined by biochemical activity assay.|48 hours after the first infusion|Attempts to stain AGT and caspase 3 were unsuccessful and there were no remaining tissues for other outcomes.||||||
1436540|NCT00961220|Primary|Overall Response Rate|"Based on changes in modified SWAT assessment, patient responses will be classified as complete clinical response (CCR), partial response (PR), stable disease (SD), or progressive disease (PD). SWAT provides an accurate and reproducible assessment of cutaneous disease involvement based on body surface area of involvement and lesional thickness.~CCR: No evidence of disease, 100% improvement for a duration of at least 4 weeks. PR: Greater than or equal to 50% decrease in SWAT score compared to baseline and improvement is maintained for at least 4 weeks. SD: Less than 50% decrease in SWAT score compared to baseline. PD: Increase of greater or equal to 25% of the SWAT score compared to baseline while the patient is actively taking the study drug"|Up to 2 weeks after completion of study treatment|Intention to treat|||participants|||Number
1436541|NCT00961181|Secondary|Device Success|"Device success defined as exact deployment of the device as documented by two different projections assessed by quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)||||participants|||Number
1436542|NCT00961181|Secondary|Technical Success|"Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|directly after intervention (after finalized treatment)||||participants|||Number
1436543|NCT00961181|Secondary|Binary In-segment Restenosis|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||participants|||Number
1436544|NCT00961181|Secondary|Binary In-stent Restenosis|"In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||participants|||Number
1436545|NCT00961181|Secondary|In-segment Diameter Stenosis (%DS)|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||percentage of re-narrowing||Standard Deviation|Mean
1436546|NCT00961181|Secondary|In-stent Diameter Stenosis (%DS)|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||percentage of re-narrowing||Standard Deviation|Mean
1436547|NCT00961181|Secondary|Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)|All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.|12 months|2 patients died, 2 patients withdrew consent, 1 patient lost to follow up|||participants|||Number
1436548|NCT00961181|Secondary|Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)|"All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.~Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR"|6 months|2 patients died, 2 patients withdrew consent|||participants|||Number
1436549|NCT00961181|Secondary|In-segment Late Lumen Loss|"In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.~Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||mm||Standard Deviation|Mean
1436550|NCT00961181|Primary|In-stent Late Lumen Loss|"In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.~Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).~Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany)."|6 months|2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA|||mm||Standard Deviation|Mean
1436551|NCT00961116|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
1436552|NCT00961116|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
1436553|NCT00961116|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 49 out of 54 enrolled subjects who completed this study.|||ng/mL||Standard Deviation|Mean
1436554|NCT00961051|Secondary|Number of Subjects With no Corneal Staining|Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.|Day 180||||participants|||Number
1436555|NCT00961051|Primary|Mean Lens Cleanliness as Measured by Light Reflectance|Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).|Day 30|Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253).|||light reflectance score||Standard Deviation|Mean
1436556|NCT00960999|Secondary|Association Between Biomarkers, Primary Tumor Control Rate, and ≥ Grade 2 Radiation Pneumonitis||From start of treatment to 1 year|||||||
1436557|NCT00960999|Secondary|Distribution of Pulmonary Function Changes by Treatment Arm and Response||From start of treatment to end of follow-up.|||||||
1436558|NCT00960999|Secondary|Distribution of FDG-PET (Fluorodeoxyglucose) Standardized Uptake Value Changes as a Potential Measure of Treatment Response and Outcomes||From start of treatment to date of failure (local, regional or distant), death or last follow-up.|||||||
1436559|NCT00960999|Secondary|1-year Overall Survival and Disease-free Survival Rate||From start of treatment to 1 year|||||||
1436560|NCT00960999|Secondary|1-year Primary Tumor Control Rate||From start of treatment to 1 year|||||||
1436561|NCT00960999|Primary|Counts of ≥ Grade 3 Adverse Events (AE) Graded by CTCAE v4 (Common Terminology Criteria for Adverse Events) That Are Definitely, Probably, or Possibly Related to Treatment (DPPRT)|Number of patients with ≥ grade 3 AE occurring within 1 year of treatment (TRT) start and reported as DPPRT among this subset of CTCAE v4: pericardial effusion, pericarditis, restrictive cardiomyopathy, dysphagia, esophagitis, esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage, rib fracture, brachial plexopathy, recurrent laryngeal nerve palsy, myelitis, atelectasis, bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, bronchial/pulmonary/bronchopleural/tracheal fistula, hypoxia, bronchial/tracheal obstruction, pleural effusion, pneumonitis, pulmonary fibrosis, skin ulceration (thorax only), FEV1 (Forced Expiratory Volume) or FVC (forced vital capacity) decline, or grade 5 related to TRT. Each arm is considered independently. For each arm, >=5 of 38 analyzable subjects experiencing a grade ≥ 3 AE during the 1st year following TRT start would determine the respective TRT excessively toxic. For each arm this design provides 88% power with a 0.10 type I error rate.|From start of treatment to 1 year|First 38 eligible patients per arm who started treatment|||participants|||Number
1436562|NCT00960986|Secondary|Percentage of Patients Achieving Remission|Remission was defined as 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≤7. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||percentage of participants|||Number
1436563|NCT00960986|Secondary|Percentage of Participants Achieving Response|Response was defined as ≥50% decrease from baseline on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score. HAMD-17 total scores ranged from 0 (not at all depressed)-52 (severely depressed).|Baseline up to 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||percentage of participants|||Number
1436564|NCT00960986|Secondary|Time to Resolve Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Nausea onset up to nausea resolve (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||days||95% Confidence Interval|Median
1436565|NCT00960986|Secondary|Time to Onset of Nausea|Events of nausea were taken from the adverse event (AE) data. Participants were censored based on the following rules: 1=study discontinuation date if the participant discontinues the study; 2=study lost to follow-up date if the participant drops out of the study.|Baseline to onset of nausea (Baseline up to 8 weeks)|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||days||95% Confidence Interval|Median
1436924|NCT00958477|Secondary|Serum Levels of Interleukin 6 (IL-6) and Interleukin 8 (IL-8)||Week 1 up to a maximum of 56 days|As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.||||||
1436566|NCT00960986|Secondary|Patient Global Impression of Improvement (PGI-I) at 1 Week and 8 Weeks|The PGI-I Rating Scale was a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction and an unstructured covariance matrix.|1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436567|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Clinical Global Impressions of Severity (CGI-S)|The CGI-S Rating Scale was a 7-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill. Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436568|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale|The HAMD-17 Sleep subscale (Items 4, 5, 6 of HAMD-17 questionnaire) evaluated initial, middle, and late insomnia. Total subscale scores ranged from 0 (no difficulty)-6 (difficulty). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436569|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation/Somatization Subscale|The HAMD-17 Retardation/Somatization subscale (Items 1, 7, 8, 14 of HAMD-17 questionnaire) evaluated dysfunction in mood, work, sexual activity, and overall motor retardation. Total subscale scores ranged from 0 (normal)-14 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436570|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale|The HAMD-17 Anxiety/Somatization subscale (Items 10, 11, 12, 13, 15, 17 of HAMD-17 questionnaire) evaluated the severity of psychic and somatic manifestations of anxiety and agitation. Total subscale scores ranged from 0 (normal)-18 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436571|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Core Mood Subscale|The HAMD-17 Core Mood subscale (Items 1, 2, 3, 7, 8 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-20 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436572|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale|"The HAMD-17 Maier subscale (Items 1, 2, 7, 8, 9, 10 of HAMD-17 questionnaire) represented the core symptoms of depression. Total subscale scores ranged from 0 (normal)-24 (severe). Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix."|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436573|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score|The HAMD-17 total score ranged from 0 (not at all depressed)-52 (severely depressed). Least squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariance matrix.|Baseline, 1 week, 8 weeks|The efficacy population included the number of participants with baseline and at least 1 post-baseline value analysed under the intent-to-treat (ITT) principle according to the drug dose they were assigned.|||units on a scale||Standard Error|Least Squares Mean
1436574|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Common Adverse Events (AEs) Score|AMDP-5 common AEs score was used to create a composite measure of AEs from previous duloxetine studies (incidence >5% and 2X placebo rate). The common AEs total score was the sum of the following 8 AMDP-5 items: 1) Mean of Item 112 (nausea) + 113 (vomiting); 2) Item 111 (dry mouth); 3) Item 115 (constipation); 4) Mean of Items 101-104 (insomnia); Item 122 (increased perspiration); 8) Item 106 (decreased appetite). Score was based on a 5-point scale: 1=absent, 2=mild, 3=moderate, 4=severe, 5=extremely severe; Higher score=worse severity.|Baseline, 1 week, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||units on a scale||Standard Error|Least Squares Mean
1436575|NCT00960986|Secondary|Mean Change From Baseline to 1-Week and 8-Week Endpoints in Association for Methodology and Documentation in Psychiatry (AMDP-5) Measure: Gastric Events Score|Gastric events scores (average of Item 112 [nausea] + Item 113 [vomiting]) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||units on a scale||Standard Error|Least Squares Mean
1436576|NCT00960986|Secondary|Mean Change From Baseline to 8-Week Endpoint in Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|Scores for AE scale Item 112 (nausea) of AMDP-5 (Week 0-8) ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe. Least Squares (LS) Means were adjusted for treatment group, site, visit and treatment-by-visit interaction, gender, age, baseline score and baseline score-by-visit interaction, and an unstructured covariate matrix.|Baseline, 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken. N = number of subjects with a baseline and post-baseline result at the Week 8 visit.|||units on a scale||Standard Error|Least Squares Mean
1436577|NCT00960986|Primary|Mean Maximum Nausea Severity, Association for Methodology and Documentation in Psychiatry (AMDP-5) Adverse Event (AE) Scale Item 112 (Nausea)|AMDP-5 AE scale Item 112 (nausea) measured nausea severity during treatment (Week 0-8). The scores ranged from 0-3: 0=Not present; 1=Mild; 2=Moderate; 3=Severe.|1 week and 8 weeks|The safety population included all participants who took at least 1 study drug dose analysed according to the drug dose actually taken.|||units on a scale||95% Confidence Interval|Mean
1436578|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
1436579|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)|Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.|Baseline to Month 6|The 'Per Protocol' population was used for this analysis. The Per-Protocol population was defined as a subset population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
1436580|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)|Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
1436581|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)|C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.|Baseline to Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
1436582|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)|The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).|Baseline and Month 6|Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.|||percent change||95% Confidence Interval|Least Squares Mean
1436583|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine|Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436584|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip|Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436585|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD|"DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436586|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD|"DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436587|NCT00960934|Secondary|LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD|"DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436591|NCT00960934|Primary|Percentage of Participants With Kidney Stones|"Evidence of kidney stone(s) was considered an event of interest and was prespecified as a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
1436592|NCT00960934|Primary|Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change|"Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).~≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
1436593|NCT00960934|Primary|Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change|"Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).~Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a Tier 1 safety event."|Baseline through Month 6|All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.|||Percentage of participants|||Number
1436594|NCT00960934|Primary|Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)|"Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as areal density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2)."|Baseline (BL) and Month 6|Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1436595|NCT00960869|Secondary|The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit|"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck."|6 months|Intent to Treat (ITT) Population|||participants|||Number
1436596|NCT00960869|Secondary|The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events|The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period|6 months|Intent to Treat (ITT) Population|||participants|||Number
1436597|NCT00960869|Secondary|The Number of Subjects With “Treatment Success”|Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.|6 months|Intent to Treat (ITT) Population|||participants|||Number
1436598|NCT00960869|Secondary|The Number of Participants With Gastric and/or Duodenal Ulcers|The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.|6 months|Intent to Treat (ITT) Population|||participants|||Number
1436599|NCT00960869|Primary|Number of Participants With Gastric Ulcer Confirmed by Endoscopy|The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.|6 months|Intent to Treat (ITT) Population|||participants|||Number
1436600|NCT00960856|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
1436601|NCT00960856|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.|||ng-hr/mL||Standard Deviation|Mean
1436602|NCT00960856|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration|Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.|||ng/mL||Standard Deviation|Mean
1436603|NCT00960843|Secondary|Rate of Weight Loss kg/wk at Day 180|Rate of weight loss = (screening weight (kg) – weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).|Screening to Day 180|Per Protocol population|||kg/week||Standard Deviation|Mean
1436925|NCT00958477|Secondary|Number of Subjects With Positive Anti-EMD 525797 Antibodies||Week 1, 3, 5, 8, 9|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||Subjects|||Number
1436604|NCT00960843|Secondary|Mean Static Intraband Pressure at Day 180|Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)|Day 180|Per Protocol population. Note, one subject in the Intraband pressure arm did not provide static intraband pressure measurements at Day 180 and is thus excluded from the analysis.|||mmHg||Standard Deviation|Mean
1436605|NCT00960843|Primary|Percent Excess Weight Change at Day 180|Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.|Screening to Day 180|Per Protocol Population - all randomized subjects without major protocol violations affecting the validity of pressure or non-pressure data.|||percentage of excess weight at screening||Standard Deviation|Mean
1436606|NCT00960687|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
1436607|NCT00960687|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.|||ng-hr/mL||Standard Deviation|Mean
1436608|NCT00960687|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 47 out of 54 enrolled subjects who completed this study.|||ng/mL||Standard Deviation|Mean
1436609|NCT00960661|Secondary|Minor Hypoglycemia Rate Per Year|Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL)|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.|||rate per year||Standard Deviation|Mean
1436610|NCT00960661|Secondary|Major Hypoglycemia Rate Per Year|Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.|30 weeks|The As-treated population includes all randomized participants who had taken at least one dose of study drug.|||rate per year||Standard Deviation|Mean
1436611|NCT00960661|Secondary|Daily Insulin Glargine Dose at Baseline and at Week 30|Daily Insulin Glargine Dose at baseline and at Week 30|Baseline, week 30|Participants analyzed were from the per protocol population (247, 263) with no missing data for this endpoint (247, 263, respectively).|||IU/day||Standard Deviation|Mean
1436612|NCT00960661|Secondary|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30|Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).|||mmHg||Standard Error|Least Squares Mean
1436613|NCT00960661|Secondary|Change in Systolic Blood Pressure (SBP) From Baseline to Week 30|Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).|||mmHg||Standard Error|Least Squares Mean
1436614|NCT00960661|Secondary|Change in Body Weight From Baseline to Week 30.|Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|baseline, week 30|Participants analyzed were 247 and 263, respectively. These were from the per protocol population (247, 263, respectively) with no missing data (247, 263, respectively).|||kg||Standard Error|Least Squares Mean
1436615|NCT00960661|Secondary|Change in Low Density Lipoprotein (LDL) From Baseline to Week 30|Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, Week 30|Participants included in the analysis = 232 and 245, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (232, 245, respectively).|||mmol/L||Standard Error|Least Squares Mean
1436616|NCT00960661|Secondary|Change in High Density Lipoprotein (HDL) From Baseline to Week 30|Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).|||mmol/L||Standard Error|Least Squares Mean
1436617|NCT00960661|Secondary|Change in Total Cholesterol From Baseline to Week 30|Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.|Baseline, week 30|Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).|||mmol/L||Standard Error|Least Squares Mean
1436618|NCT00960661|Secondary|Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.|Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Baseline, Week 30|Participants included in the analysis = 243 and 262, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (243, 262, respectively).|||mmol/L||Standard Error|Least Squares Mean
1436619|NCT00960661|Secondary|Percent of Participants Achieving HbA1c ≤ 6.5%.|Percent of participants achieving HbA1c ≤ 6.5%.|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).|||percentage of participants|||Number
1436620|NCT00960661|Secondary|Percentage of Participants Achieving HbA1C < 7.0%|Percentage of participants achieving HbA1C < 7.0%|Week 30|Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).|||Percentage of participants|||Number
1436621|NCT00960661|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).|Baseline, 30 weeks|Participants analyzed for this endpoint included the per protocol population, 247 and 263, respectively.|||percent of hemoglobin||Standard Error|Least Squares Mean
1436622|NCT00960622|Primary|Change in Peak Oxygen Uptake.|change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.|baseline and 6 months||||ml/Kg/min||Standard Deviation|Mean
1436623|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.|||ng-hr/mL||Standard Deviation|Mean
1436624|NCT00960570|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration|30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.|||ng-hr/mL||Standard Deviation|Mean
1436625|NCT00960570|Primary|Maximum Plasma Concentration (Cmax) of Efavirenz|The maximum or peak concentration that efavirenz reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96 and 120 hours after dose administration.|30 subjects were enrolled in this study. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study interventions but withdrew consent prior to the 8 hour post-dose activities on Day 31.|||ng/mL||Standard Deviation|Mean
1436626|NCT00960531|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.|||U/ml||95% Confidence Interval|Geometric Mean
1436636|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1436696|NCT00960141|Secondary|Mean Change From Baseline in Daytime Eye Symptoms Score|Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436627|NCT00960531|Primary|Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)|An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor’s clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|24 months|All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.|||percentage of participants|||Number
1436628|NCT00960531|Other Pre-specified|Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)|IgG subtypes were not assessed|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgG subtypes were not assessed.||||||
1436629|NCT00960531|Other Pre-specified|GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not statistically analyzed.|Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104|IgM was not assessed.||||||
1436630|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1436631|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1436632|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1436633|NCT00960440|Other Pre-specified|Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||participants|||Number
1436634|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1436635|NCT00960440|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1441674|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mg/dl||Standard Deviation|Mean
1436637|NCT00960440|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436638|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
1436639|NCT00960440|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
1436640|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||days||Standard Deviation|Mean
1436641|NCT00960440|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||days||Standard Deviation|Mean
1436642|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||number of events||Standard Deviation|Mean
1436643|NCT00960440|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||number of events||Standard Deviation|Mean
1436644|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436670|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5 and 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436645|NCT00960440|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436646|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1436647|NCT00960440|Secondary|Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436648|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-FS:13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1436649|NCT00960440|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue Scale (FS):13-item questionnaire, participant scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436650|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
1436651|NCT00960440|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Number of participants with optimal sleep is reported.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||participants|||Number
1436680|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.|||pg*hr/mL||Standard Deviation|Mean
1436652|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1436653|NCT00960440|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3|Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436654|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1436655|NCT00960440|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3|SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436656|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Month 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436657|NCT00960440|Secondary|Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436658|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436659|NCT00960440|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436660|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Month 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436661|NCT00960440|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436662|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436663|NCT00960440|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436664|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Month 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1436665|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436666|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436667|NCT00960440|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3|DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1436668|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436669|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436681|NCT00960323|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew from the study prior to Period II check in due to a schedule conflict.|||pg/mL||Standard Deviation|Mean
1436671|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436672|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4.5, 6|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436673|NCT00960440|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1|ACR20 response: >=20% improvement in TJC; >=20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436674|NCT00960440|Primary|Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436675|NCT00960440|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specified time points for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
1436676|NCT00960440|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Month 3|Full Analysis Set(FAS):all randomized participants who received at least 1 dose of study treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.|||percentage of participants|||Number
1436677|NCT00960375|Primary|Abstinence From Tobacco|Self-reported abstinence from tobacco + breath CO < 10 ppm|7 days|All randomized to condition|||participants|||Number
1436678|NCT00960375|Primary|Number of Cigarettes Smoked Per Day|Number of cigarettes smoked per day for the last 7 days|day|All randomized|||number of cigarettes||Standard Deviation|Mean
1436679|NCT00960323|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for colchicine.|Serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 28 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after dose administration.|24 subjects were enrolled in this study. One subject withdrew prior to Period II check-in. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 4 subjects in the Colchicine with Atorvastatin group.|||pg*hr/mL||Standard Deviation|Mean
1436682|NCT00960297|Secondary|To Assess Clinical & Pathologic Response Rate, Complete Resection Rate, Toxicity, Progression-free Survival, & Overall Survival.||60 months|||||||
1436683|NCT00960297|Primary|To Assess 3-year Overall Survival in Patients With Stage IB (>4.0 cm), II, or Select Stage III NSCLC Treated With Preoperative Carboplatin, Paclitaxel, and Bevacizumab Followed by Surgical Resection.||36 months|Study ended early due to slow accrual.||||||
1436684|NCT00960206|Secondary|Hip Follow-Up Questionnaire|"A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as satisfied below); whether they have any study hip pain (noted as no pain below); and whether they have had any surgery on the study hip during the previous year noted as no surgery below)."|6-10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips with positive three question responses at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.|||hips|Hips||Number
1436685|NCT00960206|Secondary|Radiographic Evaluation|Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.|3-5 and 10 years|Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips demonstrating radiographic failure assessment at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.|||hips|Hips||Number
1436686|NCT00960206|Secondary|Harris Hip Score|"Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|3-5 and 10 Years|Participants may have one or both hips replaced. Number of participants and hips analyzed include all enrolled. Number of hips with HHS evaluated at postoperative periods indicated is included in the outcome results posting.|||hips|Hips||Number
1436687|NCT00960206|Primary|Component Revision and Complications|The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.|10 years|Number of participants analyzed includes all subjects enrolled.|||hips|hips||Number
1436688|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable colchicine plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose. The pharmacokinetic parameter, AUC(0-∞), could not be determined for 1 subject in the Colchicine Alone group and for 2 subjects in the Colchicine with Seville orange juice group.|||pg*hr/mL||Standard Deviation|Mean
1436689|NCT00960193|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable colchicine concentration (t), as calculated by the linear trapezoidal rule.|Serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.|||pg*hr/mL||Standard Deviation|Mean
1436690|NCT00960193|Primary|Maximum Plasma Concentration (Cmax) of Colchicine|The maximum or peak concentration that colchicine reaches in the plasma.|serial pharmacokinetic blood samples drawn immediately prior to colchicine dosing on Days 1 and 18, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours after colchicine dose administration.|24 subjects were enrolled in this study. One subject was withdrawn due to failure to arrive for the Day 15 orange juice dose.|||pg/mL||Standard Deviation|Mean
1436691|NCT00960154|Primary|Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen|Overall histological quality score will be a composite of the histological metrics|Intraoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1436692|NCT00960154|Secondary|Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring||Intraoperatively and 1-2 weeks postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1436693|NCT00960141|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score|Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included. No missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436694|NCT00960141|Secondary|Physician's Global Evaluation of Allergic Rhinitis|An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436695|NCT00960141|Secondary|Patient's Global Evaluation of Allergic Rhinitis|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).|Week 2 (or upon discontinuation)|The primary efficacy analyses were based on the intention-to-treat. Since only 1 measurement was obtained during the treatment period, no missing values were imputed.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1437020|NCT00957944|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL) * kg||Standard Deviation|Mean
1436697|NCT00960141|Secondary|Mean Change From Baseline in Nighttime Symptoms Score|Mean change from baseline in Nighttime Symptoms Score on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436698|NCT00960141|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score|Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.|Baseline and Week 2|The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1436699|NCT00960115|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the duration from date of randomization to the date of discontinuation of any trial treatment (cyclophosphamide or saline, tecemotide [L-BLP25] or placebo vaccine) for any reason as reported by the Investigator. Participants who had missed 2 consecutive scheduled doses and were subsequently lost to follow-up were considered as treatment failures with event date as date of first missed administration. Participants without event still on treatment at time of analysis were censored on the date of last treatment administration.|Time from randomization to discontinuation of trial treatment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
1436700|NCT00960115|Secondary|Progression Free Survival (PFS) Time – Investigator Read|PFS time was defined as the duration from randomization to either first observation of objective PD (based on RECIST v1.0) or occurrence of death due to any cause. Participants without event still on treatment at time of analysis, or who stopped treatment for reasons other than PD or PD without radiological confirmed progression, were censored at the last imaging date. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
1436701|NCT00960115|Secondary|Time To Progression (TTP) – Investigator Read|TTP was defined as the time from date of randomization to date of radiological diagnosis of PD (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.0). In the event that radiological confirmation could not be obtained but participant was withdrawn from trial treatment or died due to disease progression, TTP was measured from date of randomization to the date of discontinuation of trial treatment. Participants without event who died from causes other than disease progression were censored at date of death. Participants without event who were lost to follow-up were censored at the date of lost to follow-up, except if they missed 2 consecutive scheduled doses, in which case they were considered as having disease progression at time of first missed administration. Participants without event with ongoing treatment at time of analysis, or who had stopped treatment for reasons other than PD, were censored on the date of last treatment administration.|Time from randomization to PD, reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT Analysis Set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
1436702|NCT00960115|Primary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (01 May 2014), whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first subject randomized in Step 2 (i.e. 03 Feb 2010), until clinical cut-off date (i.e. 01 May 2014).|ITT analysis set included all subjects randomly allocated to a treatment (tecemotide [L-BLP25] or placebo).|||Months||95% Confidence Interval|Median
1436703|NCT00960076|Secondary|Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)|Percent of subjects achieving therapeutic response (HbA1c <7.0%) at Week 18 (LOCF) (Randomized analysis set)|Week 18 (LOCF)||||Percentage of Participants|||Number
1436704|NCT00960076|Secondary|Change in FPG From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in FPG achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). FPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18||||mg/dL||Standard Error|Mean
1436705|NCT00960076|Secondary|Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in 2-hour PPG (following MMTT) achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). PPG is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18||||mg/dL||Standard Error|Mean
1436706|NCT00960076|Primary|Change in HbA1c Level From Baseline to Week 18 (LOCF)|Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus metformin at Week 18 (Randomized Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.|Baseline to week 18||||Percent||Standard Error|Mean
1436722|NCT00959985|Primary|To Assess Survey Response Scores Regarding Fear Avoidance Behavior Associated With Varying Degrees of Lymphedema|Fear avoidance behavior was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 7-28, where higher score was associated with higher level of fear of using arm (7= least fear level; 28= most fear level)|5 years|Median scores for the fear avoidance behavior section on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
1436707|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)|The IGFBP-3 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-3 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-3 were not produced.||||||
1436708|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor Binding Protein-2 (IGFBP-2)|The IGFBP-2 protein is secreted into the bloodstream where it binds to IGF-I and IGF-II. High expression levels of this protein promote the growth of several types of tumors and may be predictive of the chances of recovery of the participant. Robatumumab inhibits expression of this protein. Plasma levels of IGFBP-2 were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGFBP-2 were not produced.||||||
1436709|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-2 (IGF-II)|IGF-II is generally produced locally in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-II were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-II were not produced.||||||
1436710|NCT00960063|Secondary|Area Under the Curve During a Dosing Interval τ (AUCτ) for Robatumumab|AUCτ was defined as the area under the plasma concentration-time curve during a dosage interval (τ). Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCτ were not produced.||||||
1436711|NCT00960063|Secondary|Area Under the Curve at the Time of Final Quantifiable Sample (AUCtf) for Robatumumab|AUCtf for robatumumab was defined as the area under the curve at the time of the final quantifiable sample of robatumumab. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for AUCtf were not produced.||||||
1436712|NCT00960063|Secondary|Time to Maximum Observed Concentration (Tmax) of Robatumumab|Tmax was defined as time of Cmax of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab PK were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Tmax were not produced.||||||
1436713|NCT00960063|Secondary|Number of Participants Who Developed Anti-robatumumab Antibodies|The incidence of anti-robatumumab antibodies was to be assessed. Only participants who had a negative pre-treatment sample and a post-treatment sample were considered to be evaluable. If a participant had a single sample considered positive in the anti-robatumumab antibody assay (with the exception of pre-treatment positive participants), then they would be counted as positive in the immunogenicity assessment.|Prior to 1st and 8th doses of robatumumab, ~30 days after last dose of study drug, and 4 months after last dose of study drug (Up to ~13.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy and had a negative pre-treatment sample and a post-treatment sample.|||Participants|||Number
1437067|NCT00957801|Primary|Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)|Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.|treatment day 1||||ng/mL||Standard Deviation|Mean
1436714|NCT00960063|Secondary|Plasma Level of Insulin-like Growth Factor-I (IGF-I)|IGF-I is produced largely by the liver in response to growth hormone from the hypothalamic-pituitary axis. The IGF ligands can promote neoplastic events (cancer growth) through a number of different mechanisms. Robatumumab inhibits IGF ligand binding, IGF-stimulated receptor phosphorylation and human tumor cell proliferation. Plasma levels of IGF-I were to be analyzed on Day 1 of Cycles 1, 2, 3, 5, and approximately 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last).|On Day 1 of Cycles 1, 2, 3 and 5, and ~30 days after last dose of study drug (Up to~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for IGF-I were not produced.||||||
1436715|NCT00960063|Secondary|Maximum Observed Concentration (Cmax) of Robatumumab|Cmax was defined as the maximum observed serum concentration of robatumumab when administered in combination with other treatments. Blood samples for analysis of robatumumab pharmacokinetics (PK) were to be obtained at Cycles 1 and 2 at the following time points: predose, immediately post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post the start time of infusion. For all odd-numbered cycles (Cycle 3 and on) samples were to be obtained at each of the following two time points: predose and immediately postdose of robatumumab. Additionally, PK samples were to be obtained at the Post Study Visits 1 (30 days after last dose of robatumumab or standard treatment and 2 (approximately 4 months after last dose of robatumumab or standard treatment).|Cycles 1 & 2: pre- and post-infusion, and at 3, 6, 24, 48, 168, 336, and 504 hours post start of infusion; then pre-and post-dose in odd-numbered cycles, and Post Study Visits 1 and 2|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy. Individual data were collected, but, due to study termination and small numbers of participants, summary data for Cmax were not produced.||||||
1436716|NCT00960063|Secondary|Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)|All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs were to be identified as target lesions. Data were to be collected at Screening, every 6 weeks and at 30 days after the final dose of robatumumab or the standard treatment assigned (whichever was last). The best overall response was to be the best response recorded from the start of the treatment until disease progression/recurrence. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): >20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions; or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening, every 6 weeks and at ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.|||Participants|||Number
1436717|NCT00960063|Primary|Number of Participants With Dose Limiting Toxicities|Dose-limiting toxicity was defined by the following adverse events (AEs) that were considered possibly or probably related to either robatumumab or to its interaction with the chemotherapy regimen assigned: neutropenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 neutropenia with Grade ≥2 fever lasting 3 days; neutropenic infection; failure to recover to study entry/eligibility criteria laboratory requirement levels that resulted in a delay of 14 days between treatment cycles), thrombocytopenia (Grade 4 for >1 week that did not resolve prior to Day 1 of the next cycle; Grade 3-4 requiring a platelet transfusion on 2 separate days within a cycle) or all other AEs (Grade ≥3 [any duration] not ameliorable by supportive or symptomatic measures). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.0) was to be used to grade AEs.|Up to ~30 days after last dose of study drug (Up to ~10.3 months)|All Treated Set was defined as all participants who received ≥1 dose of robatumumab or chemotherapy.|||Participants|||Number
1436718|NCT00959985|Secondary|To Evaluate the Number of Patients With Low-level Arm Swelling in Order to Understand the Natural History of Lymphedema After Treatment for Breast Cancer|We recorded the number of participants who had low-level arm swelling, as defined by the Relative Volume Change (RVC) equation of >5%-<10%, at the time of their post-operative follow up to determine if women who had low-level arm swelling were more likely to develop lymphedema|5 years|Number and percentage of participants who had low-level arm swelling at their post-operative follow up are documented below|||Participants|||Count of Participants
1436719|NCT00959985|Secondary|To Identify the Number of Patients With Risk Factors Associated With the Onset of Lymphedema That Are Both Related and Unrelated to Treatment for Breast Cancer|Surgical and radiation therapy risk factors for lymphedema (surgery to lymph nodes, radiation to lymph nodes), as well as risk factors unrelated to breast cancer treatment such as high BMI were collected upon medical record review|5 years|The number and percentage of participants in each group who had at least 2 known risk factors for lymphedema is documented in the outcome measure data table below|||Participants|||Count of Participants
1436720|NCT00959985|Primary|To Assess Survey Response Scores Regarding Upper Extremity Function as it Associated With Varying Degrees of Lymphedema|Upper extremity functions were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 19-95, where higher score was associated with more difficulty utilizing arm for daily activities (19 = least difficulty; 95 = most difficulty)|5 years|Median scores for the upper extremity function questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
1436721|NCT00959985|Primary|To Assess Survey Response Scores Regarding Quality of Life as it Associated With Varying Degrees of Lymphedema|Quality of life was assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. Participant responses were scored on a scale from 0-141, where higher score was associated with higher post-operative quality of life (0= worst; 141= best)|5 years|Median scores for the quality of life questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
1437021|NCT00957944|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)/ mg||Standard Deviation|Mean
1436723|NCT00959985|Primary|To Assess Survey Response Scores Regarding Symptoms Associated With Varying Degrees of Lymphedema|Symptoms were assessed through the Lymphedema Evaluation Following Treatment of Breast Cancer (LEFT-BC) survey. The responses were scored on a scale from 0-51, where higher score was associated with presence of more symptoms (0=no symptoms, 51 = most symptoms)|5 years|Median scores of the symptom-related questions on the LEFT-BC survey, per group, are indicated below. Participants who did not complete or return surveys due to non-compliance were excluded from this analysis.|||units on a scale||Full Range|Median
1436724|NCT00959985|Primary|To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garments +/- Night Compression Bandaging for Moderate Volume Lymphedema Due to Breast Cancer Treatment|Participants who are randomized to receive compression treatment with/without night bandaging will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%. Data was collected in participants enrolled in Group 2A and 2B only (8 participants total), and the percentage of participants who experienced reduction in edema is reported below.|5 years|This outcome measure was compared between Groups 2A and 2B. No data was collected for Group 1A and 1B as this outcome does not apply to these groups|||Participants|||Count of Participants
1436725|NCT00959985|Primary|To Identify the Number of Patients Who Experienced Reduction in Edema With Compression Garment Usage for Low Volume Lymphedema Associated With Breast Cancer Treatment|Participants who are randomized to receive compression treatment will have their arm volume measured at regular intervals throughout the study period. Participants' arm volume, as measured by the validated Relative Volume Change (RVC) equation, at the end of the intervention period will be assessed to determine the efficacy of the compression garment intervention and whether or not it was successful in reducing the participants' arm edema to RVC<10%.Data was collected in study participants enrolled in Group 1A and Group 1B only (15 patients total), and the percentage of participants who experienced reduction in edema is reported below.|5 years|This outcome measure was compared between Group 1A (control) and Group 1B (compression garment). No data was collected for this outcome in Groups 2A and 2B|||Participants|||Count of Participants
1436726|NCT00959946|Secondary|Plasma Decay Half-Life (t1/2) - Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-life was to be calculated as 0.693/λz.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436727|NCT00959946|Secondary|Terminal-Phase Disposition Rate Constant (λz) - Part 2|The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436728|NCT00959946|Secondary|Apparent Oral Clearance (CL/F) - Part 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436729|NCT00959946|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] - Part 2|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436730|NCT00959946|Secondary|Apparent Volume of Distribution (Vz/F) - Part 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436731|NCT00959946|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436732|NCT00959946|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 2||0 hour (Pre-dose) on Day 1 and 2, 3, 4, 6, 8 and 24 hours post-dose on Day 14 of Cycle 1|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436733|NCT00959946|Secondary|Duration of Response (DR) - Part 2|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436734|NCT00959946|Secondary|Clinical Benefit Rate - Part 2|Percent of participants with confirmed CR, PR or SD for at least 24 weeks on study according to RECIST. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. SD: neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436735|NCT00959946|Secondary|Progression Free Survival (PFS) - Part 2|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436736|NCT00959946|Secondary|Best Overall Response - Part 1|Best overall response based on investigator's disease status assessment. CR: disappearance of all lesions. PR: at least 30% decrease in sum of LDs of target lesions taking as reference baseline sum LDs. Progressive disease (PD): at least 20% increase in sum of LD of target lesions taking as a reference smallest sum of the recorded LDs since treatment start, or the appearance of 1 or more new lesions. Stable disease (SD): neither sufficient shrinkage for PR nor sufficient increase for PD taking as reference smallest sum of LD since treatment started.|Part 1 Baseline, every 6 weeks up to 6 months|Per protocol (PP) population included participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine within a 21-day period, had a baseline and at least 1 post-baseline tumor assessment, and had no major protocol violations.|||Participants|||Number
1436737|NCT00959946|Primary|Percentage of Participants With Objective Response - Part 2|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions (LDs) of the target lesions taking as a reference the baseline sum LDs.|Part 2 Baseline, every 6 weeks up to 2 to 6 weeks after last dose|Data was not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1436738|NCT00959946|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after last dose of study treatment|Safety population: included participants who received at least 1 dose of the study medication.|||Percentage of Participants|||Number
1436739|NCT00959946|Primary|Maximum Tolerated Dose (MTD) - Part 1|The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level.|Part 1 Baseline up to Day 21|DLT evaluable population included all participants who received at least 14 doses of bosutinib and at least 10 doses of capecitabine in the first 21 days of treatment or had experienced a DLT within the first 21 days of treatment. N (number of participants analyzed) signifies participants who were evaluable for this measure.|||mg|||Number
1436740|NCT00959920|Secondary|Difference in Cost Between the Two Interventions|Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.|End of study.|No formal statistical testing was conducted on these measures as complete financial records were not available for the analysis.||||||
1436741|NCT00959920|Primary|Time to Delivery (by Any Route)|Time to delivery defined as IV placement to delivery of infant.|1 day|Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.|||Hours||Inter-Quartile Range|Median
1436742|NCT00959907|Primary|Horizontal Action Halo Diameter at 112 Days|Minor’s test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|112 days|Intention to treat analysis. 55 volunteers - One drop out from visit 2 (28 days) to visit 3 (112 days): 54 volunteers.|||centimeter||Standard Deviation|Mean
1436743|NCT00959907|Primary|ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)|ECMAP(Evoked Compound Muscle Action Potentials) was accessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).|28 days||||microvolts||Standard Deviation|Mean
1436744|NCT00959907|Primary|Horizontal Action Halo Diameter at 28 Days|Minor’s test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.|28 days|The analysis was intention to treat (ITT); One drop out, from baseline to visit 1(intervention) and 3 drop outs from visit 1 to visit 2 (28 days after botulinum toxin injections). Started 59 volunteers - 4 drop outs, there was 55 volunteers in the first analysis.|||centimeter||Standard Deviation|Mean
1436745|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.|||ng*hr/mL||Inter-Quartile Range|Median
1436746|NCT00959894|Secondary|Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults|Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA)|At or after 4 weeks|57 participants who provided samples at multiple time points relative to etravirine dosing.|||ng/mL||Inter-Quartile Range|Median
1436747|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
1436748|NCT00959894|Secondary|Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome measure assessed the ratio of semen:plasma concentration of etravirine in paired semen and plasma samples collected from 14 male participants at Week 4 of treatment with etravirine and fixed dose tenofovir/emtricitabine.|4 weeks|Of 79 participants who initiated study medications, 14 provided paired plasma and genital secretion samples. The goal was to enroll a total of 20 participants (10 men and 10 women) into the genital secretion sub-group, however no women enrolled into this subgroup. Data are presented for semen and plasma etravirine concentrations for 14 men.|||ratio of semen:plasma drug concentration||Inter-Quartile Range|Median
1436749|NCT00959894|Secondary|Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||ratio of trunk fat % : lower limb fat %||95% Confidence Interval|Median
1436750|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 96 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||percentage of body fat||95% Confidence Interval|Median
1436751|NCT00959894|Secondary|Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI.|Baseline to 24 weeks|This per-protocol sub-study analysis was conducted in the as-treated population of participants in the metabolic sub-study.|||percentage of body fat||95% Confidence Interval|Median
1436752|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||µU/ml*mmol/L||Inter-Quartile Range|Median
1436753|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5.|Baseline to 96 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||mg/dL||Inter-Quartile Range|Median
1437061|NCT00957801|Primary|Triglycerides Measured on Treatment Day 1 (Baseline Study)|Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
1436754|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||µU/ml*mmol/L||Inter-Quartile Range|Median
1436755|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 48 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||mg/dL||Inter-Quartile Range|Median
1436756|NCT00959894|Secondary|Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||µU/ml*mmol/L||Inter-Quartile Range|Median
1436757|NCT00959894|Secondary|Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range.|Baseline to 24 weeks|This per-protocol sub-study analysis of metabolic outcomes was conducted in the as-treated population in the metabolic sub-study.|||mg/dL||Inter-Quartile Range|Median
1436758|NCT00959894|Secondary|Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks|The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood’s variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring).|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.|||proportion of participants||95% Confidence Interval|Number
1436759|NCT00959894|Secondary|Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy|"The safety/tolerability endpoint was defined as the first grade 3 or higher sign, symptom or laboratory abnormality that was at least one grade higher than baseline among participants ever exposed to etravirine (regardless of treatment status), or permanent discontinuation of etravirine due to any toxicity (regardless of grade). Modification of tenofovir/emtricitabine was not a safety/tolerability event.~The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood’s variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring)."|96 weeks|The analysis population for this outcome is all participants who received at least one dose of etravirine, regardless of whether or not they were still receiving etravirine at the time of the safety/tolerability event.|||participants|||Number
1436760|NCT00959894|Secondary|Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results|Per-protocol, genotype testing was conducted at confirmation of virologic failure if the confirmatory HIV-1 RNA was above the laboratory-specified threshold of 500 copies/mL. HIV-1 genotype was determined using the TRUGENE® HIV-1 assay (Siemens Healthcare Diagnostics, Tarrytown, NY)|96 weeks|Of participants with confirmed virologic failure, 8 had HIV-1 RNA levels ≥ 500 copies/mL and 6 of these had viral genotype results available (1 had previously discontinued study medication at Week 2, and 1 was missing).|||participants|||Number
1436761|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 96 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 96 weeks|Of 79 participants who initiated study medications, 63 had a Week 48 CD4+ cell count measurement (6 discontinued study participation prior to Week 96 and 10 were lost to follow-up).|||cells/uL||95% Confidence Interval|Median
1436762|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 48 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI.|Baseline to 48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 CD4+ cell count measurement (4 discontinued study participation prior to Week 48 visit, 3 were lost to follow-up, and 3 missed the Week 48 visit).|||cells/uL||95% Confidence Interval|Median
1436774|NCT00959751|Secondary|Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)|Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent|24 hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.|||Participants|||Number
1436763|NCT00959894|Secondary|Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|The per-protocol analysis of change in CD4+ cell count from baseline to Week 24 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% confidence interval (CI).|Baseline to 24 weeks|Of 79 participants who initiated study medications, 73 had a Week 24 CD4+ cell count measurement (4 discontinued study participation prior to Week 24,1 missed the Week 24 visit, and 1 did not have a Week 24 CD4+ cell count measurement).|||cells/uL||95% Confidence Interval|Median
1436764|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA 200 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
1436765|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
1436766|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 24 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement (3 participants had discontinued the study, 1 was lost to follow-up, and 1 missed the Week 24 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
1436767|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|96 weeks|Of 79 participants who initiated study medications, 63 had a Week 96 HIV-1 RNA measurement (6 participants had discontinued the study and 10 were lost to follow-up). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
1436768|NCT00959894|Secondary|The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine|This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures.|48 weeks|Of 79 participants who initiated study medications, 69 had a Week 48 HIV-1 RNA measurement (4 participants had discontinued the study, 3 were lost to follow-up, and 3 missed the Week 48 visit). The analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
1436769|NCT00959894|Primary|The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24|The primary study endpoint was the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA <50 copies/ml during the Week 24 analysis window (>18 and <30 weeks post-entry).|24 weeks|Of 79 participants who initiated study medications, 74 had a Week 24 HIV-1 RNA measurement. The primary analysis was conducted intention-to-treat, with missing evaluations counted as failure.|||proportion of participants||95% Confidence Interval|Number
1436770|NCT00959764|Secondary|Change in Plasma CTx-1 From Baseline|Percent change from baseline of plasma CTx-1 at end of study=48 weeks|48 weeks|Modified Intent-to-Treat Population|||Percentage change from baseline||Standard Deviation|Least Squares Mean
1436771|NCT00959764|Secondary|Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)|Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.|24 weeks|Modified Intent-to-Treat Population|||percentage change from baseline||Standard Deviation|Least Squares Mean
1436772|NCT00959764|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine|Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.|48 weeks|Patients who were randomized, received treatment, and had at least one post-baseline BMD value measured at least 154 days after randomization.|||Percentage increase from baseline||Standard Deviation|Least Squares Mean
1436773|NCT00959751|Post-Hoc|Sustained Complete Headache Relief (Efficacy Evaluable Analysis Set)|Exploratory Post-hoc Analysis: Sustained complete headache relief is defined as a reduction in headache severity from moderate or severe to absent over all indicated time points.|2 - 48 hours|Efficacy Evaluable Analysis Set includes all subjects in the Full Analysis Set with an observed or imputed HSS (using rules predefined in the Statistical Analysis Plan [SAP]) at both the 2-hour time point and the 4-hour time point when using the modified LOCF approach|||Participants|||Number
1436775|NCT00959751|Secondary|Time (Hours) to First Use of Rescue Medication (Full Analysis Set)|Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.|24 Hours|Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.|||Participants who required rescue||95% Confidence Interval|Median
1436776|NCT00959751|Primary|Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache recurrence is defined as any subject that experiences headache relief at the given time point (i.e., 2 hours or 4 hours), who did not use rescue medication and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration. The denominator is the number of subjects who experienced headache relief at 2 hours/4 hours.|4 hours|30 and 42 placebo and NXN-188 subjects, respectivley, experienced headache relief at 2 hours. 41 and 55 placebo and NXN-188 subjects, respectively, experienced headache relief at 4 hours.|||Participants|||Number
1436777|NCT00959751|Secondary|Complete Headache Relief (Efficacy Evaluable Analysis Set)||72 hours||||Participants|||Number
1436778|NCT00959751|Secondary|Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours||||Participants|||Number
1436779|NCT00959751|Secondary|Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)|The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain|72 hours||||Participants|||Number
1436780|NCT00959751|Primary|Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)|Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.|2 hours|Modified LOCF - Efficacy Evaluable Analysis Set|||Participants|||Number
1436781|NCT00959699|Secondary|Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound|Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||percentage of participants|||Number
1436782|NCT00959699|Secondary|Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)|This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Baseline and Week 4|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||participants|||Number
1436783|NCT00959699|Secondary|Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)|The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 60|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||percentage of participants|||Number
1436784|NCT00959699|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24|EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 12|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. No participants had undetectable HCV-RNA at Week 2; the “n” value in the table below represents the number of participants with EVR at that time point.|||percentage of participants|||Number
1436785|NCT00959699|Secondary|Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)|SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving one dose of boceprevir (PegIFN-2b + RBV + Boceprevir group) or placebo to boceprevir (PegIFN-2b + RBV group), defined as the Modified Intent-to-Treat Population; this includes 2 participants who did not enter the Follow-up Period.|||percentage of participants|||Number
1436786|NCT00959699|Primary|Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication|SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.|Up to Week 72|All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.|||percentage of participants|||Number
1436787|NCT00959660|Secondary|Thigh Muscle Composition|Thigh Skeletal Muscle and Subcutaneous Fat via MRI|20 weeks||||cm^2||95% Confidence Interval|Mean
1436788|NCT00959660|Secondary|Body Composition|Total Body Fat Mass and Total Non-bone Lean Mass via DEXA|20 weeks||||kg||95% Confidence Interval|Mean
1436789|NCT00959660|Secondary|Quality of Life|Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life.|20 weeks||||units on a scale||95% Confidence Interval|Mean
1436795|NCT00959374|Secondary|Cosmesis|Photographs of scars were obtained at 12 week visit and reviewed by a independent blinded plastic surgeon. The blinded assessor scored four elements of scar appearance on a scale of 1 to 5 each, including color match, width, borders and edges, and contour and distortion. On this scale, 1 = worst, 2= poor, 3= average, 4=good and 5=excellent. For the purpose of analysis, all scores for a patient were summed into a single composite score (4-20).|12 weeks|Subjects who did not return for the 12 week follow-up visit were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1436796|NCT00959374|Primary|Total Dermal Closure Time|In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.|At time of surgery|Includes only those subjects where a deep dermal layer was closed.|||Minutes||Standard Deviation|Mean
1436797|NCT00959192|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1436798|NCT00959192|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Z-score||Standard Deviation|Mean
1436799|NCT00959192|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.|"The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.~A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction."|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1436800|NCT00959192|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1436801|NCT00959192|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
1436802|NCT00959192|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
1436803|NCT00959192|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1436804|NCT00959192|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1436805|NCT00959192|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1436812|NCT00959049|Primary|Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination|Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|30 days after the last study vaccination|Per-Protocol Population|||Percentage of participants||95% Confidence Interval|Number
1436813|NCT00959049|Primary|Geometric Mean Titer 30 Days After the Last Study Vaccination||30 days after the last study vaccination|Per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1436814|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C||7 days after vaccination|Safety population|||Participants|||Number
1436815|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B||7 days after each vaccination|Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78|||Participants|||Number
1436816|NCT00959049|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)||7 days after each vaccination|Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110|||Participants|||Number
1436817|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Saline Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Saline|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with saline intervention.|||pmol/L||Standard Deviation|Mean
1436818|NCT00958919|Secondary|Change in Level of B-endorphin Immunoreactivity During Naloxone Intervention|Change in serum levels of beta-endorphin immunoreactivity measured in pmol/L in subjects receiving Naloxone|Baseline and at the end of Resistance Load Breathing during either Period 1 (Day 3 or 4) or Period 2 (Day 5, 6 or 7) depending on randomization|Total number of subjects completing period with Naloxone intervention.|||pmol/L||Standard Deviation|Mean
1436819|NCT00958919|Secondary|Endurance Time|Length of time that subjects were able to continue Resistive Load Breathing|Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.|||minutes||Standard Deviation|Mean
1436820|NCT00958919|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.~Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.|||units on a scale||Standard Deviation|Mean
1436821|NCT00958919|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with naloxone and 10 ratings during 10 minutes of RLB with normal saline, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 154 ratings for naloxone and for normal saline.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)|Total number of subjects completing both periods of the study.|||units on a scale||Standard Deviation|Mean
1436822|NCT00958893|Primary|To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.||three 4 month cycles separated by off-drug intervals|||||||
1436823|NCT00958880|Secondary|Social Phobic Disorders Severity and Change Form|Social Phobic Disorders Severity and Change (SPDSC) Form is a version of the Clinical Global Improvement-Severity scale adapted specifically for clinician ratings of social anxiety disorder symptom severity. The scale ranges from 0 to 5, with higher scores indicating more social anxiety symptoms severity (i.e., worse outcomes). We examined the change in SPDSC scores from baseline to a 1 month follow-up.|CGI change scores from baseline to 1 month follow-up||||units on a scale||Standard Deviation|Mean
1436824|NCT00958880|Primary|The Liebowitz Social Anxiety Scale (LSAS)|The Liebowitz Social Anxiety Scale (LSAS) is a self-report measure of social anxiety symptom severity. Scores range from 0 to 144, with higher scores indicating more social anxiety symptoms severity (i.e., a worse outcome).|LSAS means at 1 month follow-up||||units on a scale||Standard Deviation|Mean
1436825|NCT00958841|Secondary|Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Six patients with Nelson’s syndrome met the responder’s criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.|||Participants|||Number
1436826|NCT00958841|Secondary|PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.|||Participants|||Number
1441675|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mg/dl||Standard Deviation|Mean
1436827|NCT00958841|Secondary|PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker|Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.|Baseline, month 6|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.|||Participants|||Number
1436828|NCT00958841|Secondary|Percentage of Responders With Probability of Success at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson’s syndrome.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.|||Percentage of participants|||Number
1436829|NCT00958841|Secondary|Percentage of Responders at Month 6 - Individual NETs|Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN.|||percentage of participants|||Number
1436830|NCT00958841|Primary|Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)|The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.|6 months|The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels >ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.|||percentage of participants|||Number
1436831|NCT00958828|Primary|Overall Lens Satisfaction|Overall Lens Satisfaction, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of 1-week’s wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 1 week of wear|Per protocol|||Units on a scale||Standard Deviation|Mean
1436832|NCT00958789|Secondary|Knee Society Score (KSS) Change From Pre-op to Post-op Visits|The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|pre-op, 1, 5 year|||||||
1436833|NCT00958789|Secondary|Lower Extremity Activity Scale Score Change From Pre-op to Post-op Visits|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-op, 1, 2, 5 years|||||||
1436834|NCT00958789|Secondary|HSS Patella Score Change From Pre-op to Post-op Visits|The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.|pre-op, 1, 2, 5 years|||||||
1436835|NCT00958789|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-op, 1, 2, 5 years|||||||
1436836|NCT00958789|Secondary|Revision Rates||5 years|||||||
1436837|NCT00958789|Secondary|Radiographic Stability|Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms. A migrating or shifting prosthesis, with or without the disappearance of radiolucent lines, should be considered as a possible or impending failure regardless of the score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Subsidence is defined as settling of the prosthetic component in bone, and is related to the distance between fixed bony landmarks on the tibia and the prosthesis.|1, 2, 5 years|||||||
1440460|NCT00931632|Secondary|Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Intent-to-treat population|||Participants|||Count of Participants
1436840|NCT00958789|Primary|Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years|"KSS Pain score, KSS Function score, Total Combined KSS~The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.~Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200)."|pre-op, 2 years|KSS Function Score at 2 years - One case had a calculable score for Function and not for Pain/Motion. Therefore, the case was not included in the Combined KSS Score and Participant Flow completed total of 131.|||units on a scale|knees|Standard Deviation|Mean
1436841|NCT00958776|Other Pre-specified|Change in Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; Fold Change From Initial|Viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented as fold change from initial sensitivity by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.|||fold change||Standard Deviation|Mean
1436842|NCT00958776|Other Pre-specified|Initial Viral Sensitivity to Peramivir, Oseltamivir, and Zanamivir; IC50 (nM)|Initial viral sensitivity to peramivir, oseltamivir, and zanamivir was assessed over time during the study, and was presented by influenza virus subtype. Initial assessment of susceptibility may have occurred at a post-baseline visit.|Initial (baseline or post-baseline) and up to 10 days|The Intent-to-Treat Infected (ITTI) population included randomized subjects who received at least 1 dose of study drug, and had confirmed influenza A or B.|||nM||Standard Deviation|Mean
1436843|NCT00958776|Other Pre-specified|Survival at 14 and 28 Days After Initiation of Study Drug (Kaplan-Meier Estimate)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Estimates and 95% confidence intervals were calculated using the method of Kaplan-Meier and presented by treatment group.|28 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||Percent Survival||95% Confidence Interval|Number
1436844|NCT00958776|Other Pre-specified|Number of Subjects Requiring More Than 5 Days of Study Drug|Subjects who had not met the protocol-defined criteria of clinical resolution on Day 5 or who had detectable virus by RT-PCR from a sample collected on Study Day 4 after dosing continued their assigned treatment for a further 5 days.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||participants|||Number
1436845|NCT00958776|Other Pre-specified|Incidence of Influenza-Related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis, and pneumonia as reported on the influenza-related complications CRF.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||participants|||Number
1436846|NCT00958776|Other Pre-specified|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study treatment until the subject was discharged from the hospital, was summarized by treatment group using the method of Kaplan-Meier. Subjects who were not discharged from the hospital were censored at their last study visit.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||days||95% Confidence Interval|Median
1436847|NCT00958776|Secondary|Duration of All ICU Admissions (Kaplan-Meier Estimate)|Duration of postbaseline ICU admission was defined as the total number of days in the ICU for those subjects who had a post-baseline admission to the ICU. Only days starting after the initial postbaseline admission were included. If a subject's stay in the ICU was ongoing, the duration was censored at the last study visit. Subjects who did not have a postbaseline admission had a duration of 0.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||days||95% Confidence Interval|Median
1436848|NCT00958776|Secondary|Number of Subjects With ICU Admission|The number of subjects requiring ICU admission post-randomization was summarized by treatment group.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||participants|||Number
1436849|NCT00958776|Secondary|Time to Resumption of Usual Activities|Time to resumption of usual activities was determined from the visual analog scale (scale ranged from 0 to 10 where 0 indicated subject was unable to perform usual activities at all and 10 indicated subject was able to perform all usual activities fully). Time to resumption of usual activities was summarized by treatment group using the method of Kaplan-Meier.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||days||95% Confidence Interval|Median
1436850|NCT00958776|Secondary|Time to Resolution of Fever (Kaplan-Meier Estimate)|Time to resolution of fever was measured as the time from initiation of study treatment until resolution of fever, maintained for at least 24 hours; temperature measurements taken less than 4 hours after antipyretic use were treated as missing values.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||hours||95% Confidence Interval|Median
1437062|NCT00957801|Primary|Total Cholesterol Measured on Treatment Day 8 (Post Study)|Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
1436851|NCT00958776|Secondary|Time to Alleviation of Clinical Symptoms of Influenza|Time to alleviation of clinical symptoms of influenza was measured as the time from the first dose of study drug through the time period in which all 7 symptoms of influenza (cough, sore throat, nasal congestion, myalgia [aches and pains], headache, feverishness, and fatigue) were absent or rated as no greater than mild for at least 24 hours. Time to alleviation of symptoms was estimated using the method of Kaplan-Meier. Subjects who did not have resolution of any individual clinical sign were censored at the time of their last non-missing assessment of that sign.|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||hours||95% Confidence Interval|Median
1436852|NCT00958776|Secondary|Change (Reduction) in Influenza Virus Titer|The reduction in viral shedding was assessed as the change from baseline in log10 tissue culture infective dose50 (TCID50/mL) and RT-PCR and was summarized for each treatment group and study visit.|Baseline and 24, 48, 108 hours|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain an NAI at randomization.|||log10 viral particles/mL||95% Confidence Interval|Median
1436853|NCT00958776|Primary|Time to Clinical Resolution (Kaplan-Meier Estimate)|Time to clinical resolution was defined as the time in hours from initiation of study treatment until normalization of at least 4 of the 5 signs within the respective normalization criteria, maintained for at least 24-hours. Time to clinical resolution was summarized by treatment group using the method of Kaplan-Meier. For subjects who did not experience clinical resolution, values were censored at the date of their last non-missing assessment of clinical resolution during the study (whether this assessment occurred as an inpatient or as an outpatient).|10 days|The Intent-to-Treat Infected-Non-NAI-Containing SOC (ITTI-Non-NAI) population included randomized subjects who received at least 1 dose of study drug, had confirmed influenza, and who received an SOC that does not contain a NAI at randomization.|||hours||95% Confidence Interval|Median
1436854|NCT00958724|Secondary|Terminal-phase Elimination Half-life|Terminal-phase elimination half-life of Neratinib at day 8 following Administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m^2 to Japanese Subjects with Cancer.|Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.|Population for pharmacokinetic analyses consisted of all subjects in this study who received at least 1 dose of neratinib and provided samples for pharmacokinetic assessments.|||hr||Standard Deviation|Mean
1436855|NCT00958724|Secondary|Area Under the Curve (AUC) Tau|AUC of Neratinib at day 8 following administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m^2 to Japanese Subjects with Cancer.|Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.|Population for pharmacokinetic analyses consisted of all subjects in this study who received at least 1 dose of neratinib and provided samples for pharmacokinetic assessments.|||ng*hr/mL||Standard Deviation|Mean
1436856|NCT00958724|Secondary|Progression Free Survival|"Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment.~Disease Progression (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions."|From first dose to last evaluation, up to 40 weeks.|Subjects who met eligibility criteria, received at least 2 weeks of continual daily dosing of neratinib and at least 2 doses of vinorelbine, and underwent at least 1 follow-up tumor assessment at 6 weeks, i.e., approximately at cycle 2. In the case of disease progression prior to 6 weeks, a clinical assessment of PD was adequate.|||weeks||95% Confidence Interval|Median
1436857|NCT00958724|Secondary|Objective Response Rate (ORR)|Proportion of subjects who achieved complete response or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From first dose date to progression or last tumor assessment, up to 40 weeks.|Safety population|||percentage of participants||95% Confidence Interval|Number
1436858|NCT00958724|Secondary|Duration of Objective Response|The duration of objective response was measured from the time at which measurement criteria were met for Complete Response (CR) or Partial Response (PR) (whichever status was recorded first) until the first date on which recurrence or Progressive Disease (PD) was objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started.|From first response date to PD/death, up to 40 weeks.|Subjects who had a partial or complete response|||weeks||95% Confidence Interval|Median
1436859|NCT00958724|Secondary|Best Overall Response|Best Overall Response in Evaluable Population per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From first dose date to progression or last tumor assessment, up to 40 weeks.|Subjects who met eligibility criteria, received at least 2 weeks of continual daily dosing of neratinib, at least 2 doses of vinorelbine, and underwent at least 1 follow-up tumor assessment at 6 weeks, ie, approximately at cycle 2. In the case of disease progression prior to 6 weeks, a clinical assessment of progressive disease was adequate.|||Participants|||Count of Participants
1436860|NCT00958724|Primary|Dose Limiting Toxicity (DLT)|Number of participants experiencing DLT of neratinib in combination with vinorelbine in Japanese patients.|From first dose date to 21st day|Safety population|||participants|||Number
1436861|NCT00958581|Secondary|Length of Hospital Stay From Admission Until Patient Discharge||1 week|Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.||||||
1436862|NCT00958581|Secondary|Total Units of Autologous and Allogenic Transfusion (Both Intraoperatively and Postoperatively Until Discharge)||1 week|Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.||||||
1436863|NCT00958581|Primary|Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)||1 Week||||ml||Standard Deviation|Mean
1436864|NCT00958568|Other Pre-specified|Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)|Relapse is defined as meeting any of the following criteria (Relapse-any reason): 50% increase in MADRS score from randomization with concomitant CGI-S of Depression score increase to a score of 4 or more (MADRS score/CGI-S Depression Score); Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 27|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1436865|NCT00958568|Secondary|Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram||Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.|||percentage of participants|||Number
1436866|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)|Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval <500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.|Randomization (Week 20) to Week 47|All randomized participants who had <500 msec QTc interval at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.|||percentage of participants|||Number
1436867|NCT00958568|Secondary|Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia’s Formula (QTcF) on Electrocardiogram|Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.|||milliseconds (msec)||Standard Error|Least Squares Mean
1436868|NCT00958568|Secondary|Percent of Participants With Suicide-Related Thoughts and Behaviors|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) C-SSRS measurements.|||percentage of participants|||Number
1436869|NCT00958568|Secondary|Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%||Week 20 to Week 47|All randomized participants who had Week 20 and at least 1 post-baseline (Weeks 21-47) weight measurements.|||percentage of participants|||Number
1436870|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Weight|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) weight measurements.|||kilograms (kg)||Standard Error|Least Squares Mean
1436871|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Glucose|Impaired to High fasting glucose: ≥100 milligrams/deciliter (mg/dL) and <126 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to High glucose: <100 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to Impaired fasting glucose is <100 mg/dL at baseline, ≥100 mg/dL and <126 mg/dL any time post baseline; Normal/Impaired to High fasting glucose: <126 mg/dL at baseline and ≥126 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had impaired or normal glucose value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.|||percentage of participants|||Number
1436872|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Glucose|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1436873|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Triglycerides|Borderline to High fasting triglycerides: ≥150 milligrams/deciliter (mg/dL) and <200 mg/dL at baseline and ≥200 mg/dL any time post baseline; Normal to Borderline fasting triglycerides: <150 mg/dL at baseline, ≥150 mg/dL and <200 mg/dL any time post baseline; Normal to High fasting triglycerides: <150 mg/dL at baseline and ≥200 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal triglycerides value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglyceride measurements.|||percentage of participants|||Number
1436874|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Triglycerides|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglycerides measurement.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1436875|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Hepatic Events|Participants with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3 times the upper limit of normal (ULN) at baseline, with ALT or AST >=3 times the ULN post-baseline and total bilirubin >=2 times ULN at the same time are considered having treatment-emergent hepatic events.|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and post-baseline (Weeks 21-47) hepatic function measurements.|||percentage of participants|||Number
1436876|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol|Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and <40 mg/dL anytime post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had normal HDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.|||percentage of participants|||Number
1436877|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1436878|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol|Borderline to High fasting LDL cholesterol: ≥100 milligrams/deciliter (mg/dL) and <160 mg/dL at baseline and ≥160 mg/dL any time post baseline; Normal to Borderline fasting LDL cholesterol: <100 mg/dL at baseline, ≥100 mg/dL and <160 mg/dL any time post baseline; Normal to High fasting LDL cholesterol: <100 mg/dL at baseline and ≥160 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal LDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.|||percent of participants|||Number
1436879|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1436880|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol|Borderline to High fasting total cholesterol: ≥200 milligrams/deciliter (mg/dL) and <240 mg/dL at baseline and ≥240 mg/dL any time post baseline; Normal to Borderline fasting total cholesterol: <200 mg/dL at baseline, ≥200 mg/dL and <240 mg/dL any time post baseline; Normal to High fasting total cholesterol: <200 mg/dL at baseline and ≥240 mg/dL any time post baseline.|Randomization (Week 20) to Week 47|All randomized participants who had borderline or normal cholesterol level at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.|||percentage of participants|||Number
1436881|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol|Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
1436882|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Dyskinesia|Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of the participants. Treatment emergent dyskinesia is defined as a score ≥3 on any one of the AIMS items 1-7 post-baseline (Weeks 21-47) or scores ≥2 on any two of the AIMS items 1-7 post-baseline (Weeks 21-47) among participants without either criteria at baseline (Week 20).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) AIMS measurements.|||percentage of participants|||Number
1436883|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Parkinsonism|Simpson-Angus Scale is used to measure Parkinsonian-type symptoms in participants exposed to neuroleptics. The scale consists of 10 items, each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items and ranges from 0-40 with higher scores indicating worse conditions. Treatment emergent parkinsonism is defined as total score ≤3 of items 1 through 10 of the Simpson-Angus scale at baseline (Week 20) and a total score >3 of items 1 through 10 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) Simpson-Angus Scale measurements.|||percentage of participants|||Number
1436884|NCT00958568|Secondary|Percent of Participants With Treatment-Emergent Akathisia|Barnes Akathisia Scale (BAS) rates observable, restless movements of drug-induced akathisia as well as the subjective awareness of restlessness and any distress associated with the akathisia. It consists of 4 items. 3 items (objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness) rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. Item 4 (global clinical assessment of Akathisia) is derived from the responses on Items 1-3 rated on a 6-point scale, with 0 being absence and 5 being extreme Akathisia. Treatment emergent akathisia is defined as a global clinical assessment score on BAS <2 at baseline (Week 20) and a global clinical assessment score on BAS ≥2 post-baseline (Weeks 21-47).|Randomization (Week 20) to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) BAS measurements.|||percentage of participants|||Number
1436885|NCT00958568|Secondary|Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work or school (Item 1), social (Item 2), and family life and home responsibilities (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) SDS score measurements. Last observation carried forward (LOCF) principle was used.|||units on a scale||Standard Error|Least Squares Mean
1452606|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 04 from Baseline (i.e., between -45 days and +9 weeks)||||mg/dL||Standard Deviation|Mean
1436886|NCT00958568|Secondary|Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)|Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.|Randomization (Week 20) to Week 47|All randomized participants who provided information of psychiatric visits and emergency room or equivalent facility visits for psychiatric illness from Week 21 to Week 47.|||visits per participant||Standard Deviation|Mean
1436887|NCT00958568|Secondary|Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47||Week 47|All randomized participants who worked for pay at Week 47.|||hours||Standard Deviation|Mean
1436888|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) CGI-S measurements.|||units on a scale||Standard Error|Least Squares Mean
1436889|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.|Randomization (Week 20), up to Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements. LOCF principle was used.|||units on a scale||Standard Error|Least Squares Mean
1436890|NCT00958568|Secondary|Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis|The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.|Randomization (Week 20), Week 47|All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements.|||units on a scale||Standard Error|Least Squares Mean
1436891|NCT00958568|Secondary|Percentage of Participants Maintaining Remission|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
1436892|NCT00958568|Secondary|Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase|Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).|||percentage of participants|||Number
1436893|NCT00958568|Secondary|Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 8 to Week 20|All participants who entered open-label stabilization treatment phase (SPIII).|||percentage of participants|||Number
1436894|NCT00958568|Secondary|Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase|A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Week 0 to Week 8|All participants who entered open-label acute treatment phase (SPII).|||percentage of participants|||Number
1436895|NCT00958568|Secondary|Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|"Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 197 and 160 for OFC and Flu groups, respectively.|||days||Full Range|Median
1436896|NCT00958568|Secondary|Time to Relapse as Measured by Hospitalization for Depression or Suicidality|"Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 217 and 220 for OFC and Flu groups, respectively.|||days||Full Range|Median
1436926|NCT00958477|Secondary|Time to Reach Observed Serum Concentration (Tmax) After Third Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
1436897|NCT00958568|Secondary|Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|"Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 190 and 160 for OFC and Flu groups, respectively.|||days||Full Range|Median
1436898|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality|Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
1436899|NCT00958568|Secondary|Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality||Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
1436900|NCT00958568|Secondary|Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score|Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill).|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
1436901|NCT00958568|Secondary|Percentage of Participants Who Relapse by Any Criteria|Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.|Randomization (Week 20) to Week 47|All randomized participants.|||percentage of participants|||Number
1436902|NCT00958568|Primary|Time to Relapse by Any Criteria|"Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were censored at their last observation."|Randomization (Week 20) to Week 47|All randomized participants are included in the time to event analyses. The numbers of participants censored are 186 and 152 for OFC and Flu groups, respectively.|||days||Full Range|Median
1436903|NCT00958477|Secondary|Minimum Percent Change From Baseline in PSA Level|Minimum percent change from Baseline in PSA Level during the study was reported.|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||percent change||Standard Deviation|Mean
1436904|NCT00958477|Secondary|Maximum Percent Change From Baseline in Prostate Specific Antigen (PSA) Level|Maximum percent change from Baseline in PSA Level during the study was reported.|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||percent change||Standard Deviation|Mean
1436905|NCT00958477|Secondary|Total Pain Score Using Brief Pain Inventory-Short Form (BPI-sf)|"BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf has 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10;‘0=No pain and 10=Pain as bad as you can imagine’.Total score is reported as average of individual questions ranges from 0 to 10, with lower scores being indicative of less pain or pain interference.Data was not available for EMD 525797 250 mg arm for FUP Weeks 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 and EMD 525797 1000 mg arm for FUP Weeks 47, 51, 55, 59, 63, 67, 71 and EMD 525797 1500 mg arm for FUP Weeks 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75 respectively as no subjects were evaluable at the specified FUP visits."|Screening; Baseline; Week 3, 5, 7; Follow-up (FUP) Week 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, 51, 55, 59, 63, 67, 71, 75; End of treatment (EOT; maximum up to 380 days) and EOS (maximum up to 394 days)|"Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here n signifies those subjects who were evaluable for this outciome measure at the specified time points."|||score on a scale||Standard Deviation|Mean
1437063|NCT00957801|Primary|Total Cholesterol Measured on Treatment Day 1 (Baseline Study)|Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
1436906|NCT00958477|Secondary|Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Best Post-baseline Score|ECOG performance status measured to assess subject’s performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. best post-baseline value (i.e. lowest score) combination.|Baseline up to 394 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||subjects|||Number
1436907|NCT00958477|Secondary|Number of Subjects With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score|ECOG performance status measured to assess subject’s performance status on a scale of 0 to 4, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair. ECOG performance status was reported in terms of number of subjects with Baseline value vs. worst post-baseline value (i.e. highest score) combination.|Baseline up to 394 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||subjects|||Number
1436908|NCT00958477|Secondary|Time to Progression (TTP)|TTP was calculated as the time between the date of imaging for the earliest visit where progressive disease was detected and the first dose date plus 1 day. Participants without event are censored on the date of last tumor assessment.|Baseline up to disease progression up to a maximum of 13.1 months|Efficacy analysis set included all subjects who received at least 1 dose of the study drug. Here “Number of Participants” analyzed signifies those subjects who were evaluable for this outcome measure.|||months|||Number
1436909|NCT00958477|Secondary|Progression-free Survival (PFS) as Per Prostate Cancer Clinical Trials Working Group 1 (PCWG1) and Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria|PFS PCWG1 criteria: time from the day treatment is initiated up to progression (for subject’s whose prostate specific antigen [PSA] level did not decrease after baseline, progression defined as 50% PSA increase relative to baseline; for subject’s whose PSA decreased after baseline, progression defined as 50% PSA increase relative to nadir [smallest PSA value post-baseline]. Progression was confirmed if progression criterion was met in next 2 assessments as well.) PFS PCWG2 criteria: time from study entry to disease progression or death. Progression was defined as first appearance of progression according to PSA (for subject’s whose PSA decreased after baseline, progression was defined as 25% PSA increase relative to nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well; for subject’s whose PSA did not decrease after baseline, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline).|Baseline up to 394 days|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||months||95% Confidence Interval|Median
1436910|NCT00958477|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD:defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Week 6, Week 19, Overall (Baseline Up to 394 days)|Efficacy analysis set included all subjects who received at least 1 dose of the study drug.|||subjects|||Number
1436911|NCT00958477|Secondary|Accumulation Ratio of AUC (R_AUC)|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.|pre-dose, end of infusion, 4, 8, 24, 48, 96,168 hours post-infusion at Week 1 and pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1436912|NCT00958477|Secondary|Accumulation Ratio Of Cmax (R_Cmax)|Accumulation ratio for Cmax was calculated as Cmax, after third dose/Cmax, after first dose.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1 and Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1436913|NCT00958477|Secondary|Apparent Volume of Distribution at Steady State (Vss) of EMD 525797 After Third Infusion|Apparent volume of distribution at steady-state was reported. Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||Liters||Geometric Coefficient of Variation|Geometric Mean
1436914|NCT00958477|Secondary|Mean Residence Time of Drug in the Body (MRT) of EMD 525797 After First Infusion|Mean residence time of drug in the body calculated as: AUMC0-inf / AUC0-inf, where AUMC0-inf is the area under the first moment curve from time zero to infinity. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||hours||Geometric Coefficient of Variation|Geometric Mean
1436915|NCT00958477|Secondary|Peak Trough Fluctuation Over One Dosing Interval at Steady State (%PTF) of EMD 525797 After Third Infusion|The peak trough fluctuation over one dosing interval at steady state, calculated as PTF (%) = ( [ Cmax - Cmin ] / Cav )*100|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||percentage of fluctuation||Geometric Coefficient of Variation|Geometric Mean
1436916|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of EMD 525797 After First Infusion|Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1436917|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After Third Infusion|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96,168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1436918|NCT00958477|Secondary|Area Under the Serum Concentration-time Curve Within One Complete Dosing Interval (AUCtau) of EMD 525797 After First Infusion|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (168 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96 and 168 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1436919|NCT00958477|Secondary|Average Serum Concentration at Steady State (Cav) of EMD 525797 After Third Infusion|The average serum concentration at steady state, calculated as Cav = AUCtau/tau, where tau is the dosing interval (336 hours).|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168, 336 hours post third infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1436920|NCT00958477|Secondary|Observed Minimum Serum Concentration (Cmin) of EMD 525797 After Third Infusion|Observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
1436921|NCT00958477|Secondary|Elimination Rate Constant (λz) of EMD 525797 After First Infusion|Elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||1/h||Geometric Coefficient of Variation|Geometric Mean
1436922|NCT00958477|Secondary|Apparent Terminal Half-life (t1/2) of EMD 525797 After First Infusion|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where ‘λz’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||hours||Full Range|Median
1436923|NCT00958477|Secondary|C-Reactive Protein Levels||Week 1 up to a maximum of 56 days|As per change in planned analysis, it was decided that that the biomarker analysis were not significantly associated with compound administration and thus the data was not collected for this outcome.||||||
1436927|NCT00958477|Secondary|Time to Reach Observed Serum Concentration (Tmax) After First Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||hours||Full Range|Median
1436928|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 5|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 5|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
1436929|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 3|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 3|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
1436930|NCT00958477|Primary|Trough Serum Concentration (Ctrough) Of EMD 525797 at Week 1|Ctrough is the concentration prior to study drug administration.|pre-dose at Week 1|PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here “Number of Participants analyzed” signifies those subjects who were evaluable for this outcome measure for each arm, respectively.|||mcg/mL||Standard Deviation|Mean
1436931|NCT00958477|Primary|Apparent Volume of Distribution During Terminal Phase (Vz) of EMD 525797 After First Infusion|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as = Dose/(AUC0-inf *λz) after first infusion. Where ‘λz’ is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||Liters||Geometric Coefficient of Variation|Geometric Mean
1436932|NCT00958477|Primary|Total Body Clearance of Drug From Serum (CL) After First Infusion|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Total body clearance of drug from serum, calculated as CL = dose/AUC0-inf. Where AUC0-inf is area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above lower limit of quantification (LLQ) and λz is elimination rate constant.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||L/h||Geometric Coefficient of Variation|Geometric Mean
1436933|NCT00958477|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) After First Infusion|Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log linear trapezoidal rule.|pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1436934|NCT00958477|Primary|Observed Maximum Serum Concentration (Cmax) of EMD 525797 After Third Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 5|"PK analysis set included all subjects who received at least the first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797. Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
1436935|NCT00958477|Primary|Observed Maximum Serum Concentration (Cmax) of EMD 525797 After First Infusion||pre-dose, end of infusion, 4, 8, 24, 48, 96, 168 and 336 hours post-infusion at Week 1|"Pharmacokinetic (PK) analysis set included all subjects who received at least first dose of the study drug according to the protocol and who provided sufficient data for a concentration time profile for EMD 525797.Here Number of Participants analyzed signifies those subjects who were evaluable for this outcome measure for each arm, respectively."|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
1436944|NCT00958360|Secondary|Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Overall Visual Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
1437064|NCT00957801|Primary|Hematocrit Measured on Treatment Day 8 (Post Study)|Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.|treatment day 8||||percent||Standard Deviation|Mean
1436936|NCT00958477|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Related TEAEs|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.Treatment-related are events which had causal relationship to study drug as assessed by the Investigator and were suspected to be reasonably related to the study drug.|Baseline up to 534 days|Safety analysis set included all subjects who received at least 1 dose of the study medication and had at least 1 follow-up safety measure.|||Subjects|||Number
1436937|NCT00958477|Primary|Number of Subjects With Dose Limiting Toxicity (DLT)|DLT was defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 as any Grade 3 or 4 hematological or non-hematological toxicity occurring at any dose level until the end of Week 6, and suspected to be reasonably related to the investigational product by the Investigator and/or Sponsor except for allergic/ hypersensitivity reactions and any Grade 3/4 out-of-range laboratory values without any clinical correlate, which were reversible within 7 days.|Baseline up to 6 weeks|DLT analysis set: all subjects who experienced any DLT during first 6 weeks, regardless of number of doses of drug administered or who were considered completers (did not discontinue treatment for any reason other than DLT, were compliant, did not deviate in drug administration for more than +/-2 days due to any reason other than related toxicity).|||subjects|||Number
1436938|NCT00958438|Secondary|Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flare days||Standard Deviation|Mean
1436939|NCT00958438|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flare days per participant was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flare days||Standard Deviation|Mean
1436940|NCT00958438|Secondary|Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
1436941|NCT00958438|Secondary|Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
1436942|NCT00958438|Secondary|Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)|Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.|Day 1 to Day 113 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flares||Standard Deviation|Mean
1436943|NCT00958438|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure.|Day 1 to Day 113 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flares||Standard Deviation|Mean
1436945|NCT00958360|Secondary|Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Motor Skills subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
1436946|NCT00958360|Secondary|Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Information Processing subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
1436947|NCT00958360|Secondary|Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Mobility subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
1436948|NCT00958360|Primary|Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire|The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities.|changes from baseline to 4 months later||||logits||Standard Deviation|Mean
1436949|NCT00958347|Primary|Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.||25 Years Post-Operatively|The study was closed and no subjects reached the 25 year postoperative endpoint.||||||
1436950|NCT00958334|Secondary|Change From Baseline of ZPU-003 Ext to 14 Months in Subject's Menstrual Pictograms(Subjects Evaluable for Menorrhagia Only)||baseline and 14 months|||||||
1436951|NCT00958334|Primary|The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext.|An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data.|baseline, 14 months (3-4 cycles), 17 months|Intent to treat population|||mL||Standard Deviation|Mean
1436952|NCT00958308|Secondary|Frequencies of Other Gastrointestinal Symptoms.|Episodes of gastrointestinal disorders during hospitalization were recorded by patient interview and were confirmed by review of patient diaries.|Up to 40 days|||||||
1436953|NCT00958308|Secondary|Safety Profile of BIO-K+CL1285® Versus Placebo in Hospitalized Patients.|Adverse events were reported by patients in the three study groups.|Up to 40 days|||||||
1436954|NCT00958308|Secondary|Frequency of Stool Samples Positive for Clostridium Difficile (C. Difficile) Toxin A and/or B.|If diarrhea occured while hospitalized, patients provided a stool sample for C. difficile analysis of Toxin A and/or B. All episodes were recorded by a nurse of clinician on a case report form using the seven-item Bristol Stool Form Scale (Riegler et al., 2001). A diarrhea episode was described as a bowel movement consisting of watery stool with or without solids.|Up to 40 days|||||||
1436955|NCT00958308|Secondary|Severity of AAD in Hospitalized Patients Ingesting BIO-K+CL1285® or Placebo.|Duration of diarrhea was determined by number of continuous days of diarrhea. Average number of liquid stools per day was determined by the sum of the number of liquid stools per day in the AAD episode divided by the duration of diarrhea in days.|Up to 40 days|||||||
1436956|NCT00958308|Primary|To Assess if Probiotic Prophylaxis (BIO-K+CL1285®) is Effective for the Prevention of AAD in Hospitalized Patients.|Incidence of AAD data were collected using questionnaire and diaries given to participants upon discharge. Diagnosis of AAD was made when a patient produced three or more liquid stools in a 24h period after antibiotic treatment with no other obvious reason for diarrhea.|Up to 40 days||||participants|||Number
1436957|NCT00958282|Secondary|Drug Craving|"On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale.~The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being very little to 100 being very much."|14 Weeks||||units on a scale||Standard Error|Mean
1436958|NCT00958282|Primary|Cocaine-positive Urine Results|At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.|14 Weeks||||percentage of BE urine tests||Standard Deviation|Mean
1436959|NCT00958256|Primary|Response Rate|Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.|Evaluation of disease after 2 cycles (approximately 6 weeks).|Twenty-one patients were evaluable for response assessment (100%), of whom 16 responded (76%) thus reflected are the percentage of responses to total responders (i.e. 11 (52%) of total evaluable achieved a complete response).|||percentage of participants|||Number
1436960|NCT00958243|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).|Up to 180 days after the last vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
1437018|NCT00957944|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
1436961|NCT00958243|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"UAE grading:~Grade 1: Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities."|During the 21 days after each vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
1436962|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data. In Cohort B, Safety Population after the first vaccination are placebo group 28, 7.5 mcg group 107 and 15 mcg group 109; and 27, 105 and 103 respectively after the second vaccination.|||Days||Standard Deviation|Mean
1436963|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination||21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
1436964|NCT00958243|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination||21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
1436965|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
1436966|NCT00958243|Secondary|Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A||During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.In Cohort A, Safety Population after the first vaccination are placebo group 26, 7.5 mcg group 105 and 15 mcg group 96; and 25, 101 and 91 respectively after the second vaccination.|||Days||Standard Deviation|Mean
1436967|NCT00958243|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A|Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.|During the 7 days after each study vaccination|Safety Population comprised all randomized participants who received at least one dose of study vaccine and had provided follow-up safety data.|||Percentage of participants|||Number
1436968|NCT00958243|Primary|Seroconversion Rate 21 Days After Second Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second study vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
1436969|NCT00958243|Primary|Seroconversion Rate 21 Days After First Study Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first study vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 between Visit 1 and Visit 3).|||Percentage of participants||95% Confidence Interval|Number
1436970|NCT00958217|Primary|Timeline Followback|The Timeline Followback is a calendar-assisted structured interview that assesses the frequency of alcohol and drug use on a daily basis and the quantity of alcohol use. Summary proportion of days abstinent were calculated at each time point. Trajectory analyses examine two substance use outcomes: probability of any alcohol or drug use on a given day and probability of heavy drinking (5 or more drinks consumed in a day) on a given day. Trajectories of substance use (any alcohol or drug use on a particular day) and heavy drinking (>5 drinks on a particular day) were modeled as dichotomous outcomes, using logit links to predict the probability of substance use or heavy drinking on a particular day. Data Table reports starting proportion of days abstinent at time of randomization.|Assessed quarterly; trajectories analyzed from randomization through end of study (covering approximately 15 months)||||proportion of days abstinent||Standard Deviation|Mean
1437019|NCT00957944|Secondary|Tmax of Unconjugated Rotigotine|The tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Full Range|Median
1436971|NCT00958217|Primary|Posttraumatic Stress Disorder (PTSD) Symptoms|The Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) is a 17 item self-report checklist of PTSD symptoms experienced in the past month rated on a 1 (not at all) to 5 (extremely) scale; total score is summed from the item scores and range from 17 (none) to 85 (most severe). . Civilian version was selected as it allows for a variety of trauma types. Scores above 50 are considered clinical levels. We tested whether treatment group interacted with time to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores. This analytic approach was advantageous in that it provided examination of change in PTSD across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)||||units on a scale||Standard Deviation|Mean
1436972|NCT00958217|Primary|Depression Symptoms Were Assessed With the Hamilton Depression Rating Scale.|Depression symptoms were assessed using a structured clinical interview assessment consisting of 21 items. Depression symptoms experienced in the past week are rated on a 0 (none) to 4 (most severe) scale. The total score is summed from the item scores and range from 0 (none) to 84 (most severe). We tested whether treatment group interacted with time in order to examine whether trajectories of symptom scores differed across treatment conditions. Linear mixed effects models were used to ascertain trajectories of total scores from randomization through end of study (6 timepoints across approximately 15 months). This analytic approach was advantageous in that it provided examination of change in depression across all quarterly assessments. Models were estimated with maximum likelihood methods. Total score at the time of randomization is reported in Data Table and coefficient estimates for trajectories are reported in Statistical Analysis.|Assessed quarterly; trajectories analyzed total scores from randomization through end of study (6 timepoints covering approximately 15 months)||||units on a scale||Standard Deviation|Mean
1436973|NCT00958191|Secondary|Implant Survivorship|Implant survivorship is determined using the Kaplan-Meier method.|10 years|"Participants with available data. The population includes all 240 cases who were initially consented to 5 year study.~There are 127 cases who consented to continue in the 10 year study."|||percentage of hips|hips||Number
1436974|NCT00958191|Secondary|Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change|Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
1436975|NCT00958191|Secondary|Mean SF-12 Health Survey Score to Assess Change|Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
1436976|NCT00958191|Secondary|Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change|"The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.~211-300 degrees = 5 points~161 to 210 degrees = 4 points~101 to 160 degrees = 3 points~61 to 100 degrees = 2 points~31 to 60 degrees = 1 points~0 to 30 degrees = 0 points"|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
1436977|NCT00958191|Secondary|Mean Harris Hip Score (HHS) Pain Score to Assess Change|"The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.~None or ignores it = 44 points~Slight, occasional, no compromise in activities = 40 points~Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points~Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points~Marked pain, serious limitation of activites = 10 points~Totally disabled, crippled, pain in bed, bedridden = 0 points"|pre-operative, 1,3, and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
1436978|NCT00958191|Secondary|Mean Harris Hip Score (HHS) to Assess Change|"The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.~90 - 100 = excellent~80 - 89 = good~70 - 79 = fair~0 - 69 = poor"|pre-operative, 1,3 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale|Hips|Standard Deviation|Mean
1436979|NCT00958191|Secondary|Radiographic Stability|Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.|1,2,3,4 and 5 years|Participants/hips with available data. Overall number of participants and units analyzed is based upon the 1 year population.|||hips evaluated as unstable on radiograph|Hips||Number
1452607|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 03 from Baseline (i.e., between -45 days and +6 weeks)||||mg/dL||Standard Deviation|Mean
1436980|NCT00958191|Secondary|Volumetric Wear Rate of the Trident X3 Polyethylene Insert|"Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate.~NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear."|2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed|Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.|||cubic mm/year|Hips||Number
1436981|NCT00958191|Secondary|Linear Wear Rate of the Trident X3 Polyethylene Insert|"Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period.~NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear."|2, 3 and 4 year films collected; 3 and 4 year wear assessed|Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.|||mm/year|Hips|Standard Deviation|Mean
1436982|NCT00958191|Primary|Rate of Incidence of Revision of Component for Any Reason|Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.|5 year|Difference of 5 participants from the participant flow completed (=110): 4 participants are included in the revision category of the participant flow and one participant had revision of only the femoral head & stem but later withdrew from the study & is included in the withdrawal category of the participant flow.|||percentage of hips undergoing revision|Hips||Number
1436983|NCT00958191|Primary|Mean Linear Wear Rate at 5 Years|Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years|5 years||||mm/year|Hips|Standard Deviation|Mean
1436984|NCT00958165|Primary|Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.||12 months|Of the 72 enrolled and treated participants, 67 were evaluable for the chronic effectiveness endpoint.|||Successful participants|||Number
1436985|NCT00958126|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination|"Unsolicited adverse event (UAE) grading:~Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.~Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.~Grade 3 (severe): Symptoms that prevented normal, everyday activities."|Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.|||percentage of participants|||Number
1436986|NCT00958126|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)|A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all randomized participants who received at least one dose of study vaccine and provided follow-up safety data.|||percentage of participants|||Number
1436987|NCT00958126|Primary|Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1436988|NCT00958126|Primary|Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1436989|NCT00958126|Primary|Seroconversion Rate 21 Days After the Second Vaccination|Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1436990|NCT00958126|Secondary|Duration of Solicited Local Adverse Events After the First Vaccination||During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.|||days||Standard Deviation|Mean
1436991|NCT00958126|Secondary|Frequency and Intensity of Solicited Adverse Events After the First Vaccination|Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.|During the 7 days after the first vaccination|The Safety Population (first vaccination) comprised all randomized participants who received the first vaccination and provided follow-up safety data.|||percentage of participants|||Number
1436992|NCT00958126|Primary|Seroconversion Rate 21 Days After the First Vaccination|Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1436993|NCT00958074|Secondary|Changes in the Physicians Serial Assessment of Erythroderma Score||Baseline to 30 days post-treatment|||||||
1436994|NCT00958074|Secondary|Changes in Sezary Cell Count Measured by Serial Flow Cytometry Measurements||Baseline to 30 days post-treatment|||||||
1436995|NCT00958074|Secondary|Safety and Tolerability of Dose-adjusted Vorinostat|Toxicities will be graded in severity according to the guidelines outlined in the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.|Up to 30 days post-treatment|||||||
1436996|NCT00958074|Secondary|Objective Response Rate of Extracutaneous Manifestations of CTCL (Lymph Node Enlargement, Sezary Cells in Peripheral Blood);|Assessed by changes in the sum of the products in the greatest diameters of enlarged lymph nodes by serial computed tomography (CT) or positron emission tomography (PET)/CT scans.|Up to 30 days post-treatment|||||||
1436997|NCT00958074|Primary|Objective Response|Defined as either no evidence of clinical disease or marked improvement (>= 50%) decrease in the modified Severity-Weighted Assessment Tool (mSWAT) skin assessment score compared to baseline.|After at least 14 days. With Confirmation after additional 28 days.|In cohort 1, only 3 of the 4 subjects consented were used for analysis. 1 patient in this cohort only completed 3 days of treatment before removing themselves from treatment and withdrawing consent. This patient was deemed inevaluable, as the timeframe for initial evaluation is 14 days.|||percentage of total|||Number
1436998|NCT00958035|Primary|Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4|Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).|Month 4|Intent-to-Treat: All randomized subjects|||Percentage of Patients|||Number
1436999|NCT00958009|Secondary|Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes.|The User Trial Questionnaire was used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, safety and portability of the device. Mean and confidence intervals refer to proportion of subjects responding positively to question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of IMP were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.|||Proportion of subjects||95% Confidence Interval|Mean
1437000|NCT00958009|Primary|Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire|Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.|at 12 weeks|Subjects in the all enrolled analysis set who received at least one dose of investigational medicinal product (IMP) were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.|||Proportion of subjects||95% Confidence Interval|Mean
1437001|NCT00957996|Secondary|Survival (Kaplan-Meier Estimates)|Survival was calculated as the number of days from initiation of study drug until death or last contact. Overall survival was estimated by the method of Kaplan-Meier; 95% confidence intervals for 14- and 28-day survival were presented by treatment group. Subjects who had not died were censored at the date of last contact.|14 and 28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||Percent Survival||95% Confidence Interval|Number
1437002|NCT00957996|Other Pre-specified|Number of Participants Who Required More Than 5 Days of Peramivir Treatment|The number of subjects who continued more than 5 days were as reported on the Continuation of Treatment CRF page.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
1437003|NCT00957996|Secondary|Duration of Postbaseline ICU Admission (Kaplan-Meier Estimate)|The duration of ICU admission after initiation of treatment was estimated by the method of Kaplan-Meier. Subjects who were not discharged from the ICU were censored at the time of their last assessment|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||days||95% Confidence Interval|Median
1437004|NCT00957996|Secondary|Number of Participants Admitted to ICU After Initiation of Treatment|The number of subjects experiencing ICU admission after initiation of treatment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
1437005|NCT00957996|Secondary|Number of Participants Experiencing Influenza-related Complications|Influenza-related complications were defined as the occurrence of sinusitis, otitis, bronchitis and pneumonia as reported on the Influenza-related complications CRF.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
1437065|NCT00957801|Primary|Hematocrit Measured on Treatment Day 1 (Baseline Study)|Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.|treatment day 1||||percent||Standard Deviation|Mean
1437006|NCT00957996|Secondary|Time to Hospital Discharge|Time to hospital discharge, defined as the number of days from initiation of study drug until the subject is discharged from the hospital, was estimated using the method of Kaplan-Meier. The 95% confidence interval about the median was presented. Subjects who were not discharged during the study period were censored at the last study visit. Subjects who died prior to discharge were censored at the longest observed time to discharge.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||days||95% Confidence Interval|Median
1437007|NCT00957996|Secondary|Time to Resumption of Usual Activities|Subject’s ability to perform usual activities as determined from the visual analog scale (scale ranges from 0 to 10 where 0 indicates subject was unable to perform usual activities at all and 10 indicates subject is able to perform all usual activities fully) was summarized by study visit day and treatment group. The median time to resumption of usual daily activities and associated 95% CI was estimated using the method of Kaplan-Meier for adults and adolescents. Subjects who did not return to the pre-study level of performance of usual daily activities were censored at the time of their last non-missing visual analog scale value. A separate analysis was conducted for children.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||hours||95% Confidence Interval|Median
1437008|NCT00957996|Secondary|Time to Resolution of Fever|Time to resolution of fever was the number of hours from initiation of study treatment until temperature was ≤37.2°C/≤99°F oral or ≤37.8°C/≤100°F rectal or tympanic for at least 24 hours with no antipyretic medication taken within 4 hours prior to the temperature measurement. Subjects who did not achieve resolution of fever were censored at the time of their last assessment. The 95% confidence interval about the median were presented.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||hours||95% Confidence Interval|Median
1437009|NCT00957996|Secondary|Time to Alleviation of Symptoms|Time to alleviation of symptoms, defined as the time from initiation of study drug until the start of the 24 hour period where all seven symptoms of influenza are recorded as none or mild, was estimated using the method of Kaplan-Meier (adolescents and adults). The 95% confidence interval about the median was presented. Subjects who did not experience alleviation of symptoms were censored at the time of the last non-missing symptom assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Symptom data for 18 subjects was missing.|||hours||95% Confidence Interval|Median
1437010|NCT00957996|Secondary|Number of Participants With Clinical Resolution|Clinical resolution was defined as normalization of at least 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) for at least 24 hours.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||participants|||Number
1437011|NCT00957996|Secondary|Time to Clinical Resolution|Time to clinical resolution was the number of hours from initiation of study treatment until 4 of the 5 signs of clinical stability (including both body temperature and transcutaneous oxygen saturation) met resolution criteria that was maintained for at least 24 hours. The median time to clinical resolution and associated 95% confidence interval were estimated for each treatment group using the method of Kaplan-Meier. Subjects who did not achieve clinical resolution were censored at the time of their last assessment.|28 days|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology.|||hours||95% Confidence Interval|Median
1437012|NCT00957996|Secondary|Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)|The time-weighted change from baseline in viral titer measured by RT-PCR was calculated on a by-subject basis through 216 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline, 48, 108, 216 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 41 subjects were excluded due to negative Baseline titers (viral particles/mL RT-PCR value 1.58 for Influenza A and 1.49 for Influenza B).|||log10 viral particles/mL||95% Confidence Interval|Median
1437013|NCT00957996|Primary|Change From Baseline in Influenza Virus Titer (48 Hours)|The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.|Baseline and 48 hours|The Intent-to-Treat Infected (ITTI) population included all randomized subjects who received at least 1 dose/infusion of study drug, and had confirmed influenza A or B by culture, PCR, or serology. Overall, 83 subjects were excluded due to negative Baseline titers (log10 TCID50 0.5).|||log10 TCID50/mL||95% Confidence Interval|Median
1437014|NCT00957944|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)|||mg||Standard Deviation|Mean
1437015|NCT00957944|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||L/h||Standard Deviation|Mean
1437016|NCT00957944|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
1437017|NCT00957944|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||1/ hour (1/h)||Standard Deviation|Mean
1437022|NCT00957944|Secondary|AUC(0-∞) Norm (BW)|The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h*kg||Standard Deviation|Mean
1437023|NCT00957944|Secondary|AUC(0-∞) Norm (Apparent Dose)|The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
1437024|NCT00957944|Secondary|AUC(0-tz) Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz) norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h*kg||Standard Deviation|Mean
1437025|NCT00957944|Secondary|AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
1437026|NCT00957944|Primary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
1437027|NCT00957944|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||ng/ mL||Standard Deviation|Mean
1437028|NCT00957944|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
1437029|NCT00957931|Secondary|Count of Participants With Disease-free Survival 1 Year Following HCT|Disease-free survival is defined as alive without underlying disease.|1 year||||Participants|||Count of Participants
1437030|NCT00957931|Secondary|Count of Participants With Disease-free Survival 6 Months Following HCT|Disease-free survival is defined as alive without underlying disease.|6 months||||Participants|||Count of Participants
1437031|NCT00957931|Secondary|Overall Survival 1 Year Following HCT|Overall survival is reported at the count of participants alive 1 year following HCT.|1 year||||Participants|||Count of Participants
1437032|NCT00957931|Secondary|Overall Survival 6 Months Following HCT|Overall survival is reported at the count of participants alive 6 months following HCT.|6 months||||Participants|||Count of Participants
1437033|NCT00957931|Primary|Count of Participants With Stable Engraftment Post Hematopoietic Cell Transplantation (HCT)|Stable engraftment was defined as absolute neutrophil count (ANC) >500 cells /µL for 3 consecutive days and platelet count >50,000 for one week without transfusion; subsequently stable engraftment was measured by percentage of donor cells.|Up to 1 year||||Participants|||Count of Participants
1437034|NCT00957905|Other Pre-specified|Time to Tumor Response||From treatment start until first documented CR or PR, assessed up to 4 years|||||||
1437035|NCT00957905|Other Pre-specified|Progression-free Survival||From treatment start until first documented progression or death, assessed up to 4 years|||||||
1437036|NCT00957905|Other Pre-specified|Toxicity|graded using the NCI CTCAE version 4.0.See adverse event section|Up to 4 years|||||||
1437037|NCT00957905|Primary|Objective Response Rate|"Number of Participants with Partial Response (PR), Stable Disease (SD), Progression of Disease (POD) Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Within 3 courses of treatment||||participants|||Number
1437038|NCT00957801|Primary|Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the treatment week average of study days 1-8."|Study days 1-7 (treatment week)|1 subject did not complete the BFI during treatment week.|||units on a scale||Standard Deviation|Mean
1437039|NCT00957801|Primary|Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions.~This data is presented as the pre-treatment week average of study days -7 to -1."|Study days -7 to -1 (Pre - treatment)||||units on a scale||Standard Deviation|Mean
1437040|NCT00957801|Primary|Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 8 - after exercise||||ug/dL||Standard Deviation|Mean
1441676|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mg/dl||Standard Deviation|Mean
1437041|NCT00957801|Primary|Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 8 - before exercise||||ug/dL||Standard Deviation|Mean
1437042|NCT00957801|Primary|Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 1 - after exercise||||ug/dL||Standard Deviation|Mean
1437043|NCT00957801|Primary|Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol|Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.|treatment day 1 - before exercise||||ug/dL||Standard Deviation|Mean
1437044|NCT00957801|Primary|Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)|Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.|treatment day 8||||ng/mL||Standard Deviation|Mean
1437045|NCT00957801|Primary|Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)|Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.|treatment day 1||||ng/mL||Standard Deviation|Mean
1437046|NCT00957801|Primary|Insulin Measured on Treatment Day 8 (Post Study)|Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.|treatment day 8||||uIu/mL||Standard Deviation|Mean
1437047|NCT00957801|Primary|Insulin Measured on Treatment Day 1 (Baseline Study)|Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.|treatment day 1||||uIu/mL||Standard Deviation|Mean
1437048|NCT00957801|Primary|Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)|Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.|treatment day 8||||nmol/L||Standard Deviation|Mean
1437049|NCT00957801|Primary|Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)|Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.|treatment day 1||||nmol/L||Standard Deviation|Mean
1437050|NCT00957801|Primary|Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)|Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.|treatment day 8||||ug/dL||Standard Deviation|Mean
1437051|NCT00957801|Primary|Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)|Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.|treatment day 1||||ug/dL||Standard Deviation|Mean
1437052|NCT00957801|Primary|C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)|C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
1437053|NCT00957801|Primary|C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)|C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
1437054|NCT00957801|Primary|Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)|Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
1437055|NCT00957801|Primary|Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)|Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
1437056|NCT00957801|Primary|Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)|Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
1437057|NCT00957801|Primary|Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)|Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
1437058|NCT00957801|Primary|High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)|High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
1437059|NCT00957801|Primary|High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)|High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.|treatment day 1||||mg/dL||Standard Deviation|Mean
1437060|NCT00957801|Primary|Triglycerides Measured on Treatment Day 8 (Post Study)|Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.|treatment day 8||||mg/dL||Standard Deviation|Mean
1437070|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 8 (Post Study)|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 8||||ng/dL||Standard Deviation|Mean
1437071|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 7|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 7||||ng/dL||Standard Deviation|Mean
1437072|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 6|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 6||||ng/dL||Standard Deviation|Mean
1437073|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 5|"TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 5||||ng/dL||Standard Deviation|Mean
1437074|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 4|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 4|One subject missed a testosterone monitoring visit for treatment day 4.|||ng/dL||Standard Deviation|Mean
1437075|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 3|"TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 3||||ng/dL||Standard Deviation|Mean
1437076|NCT00957801|Primary|Serum Total Testosterone Measured on Treatment Day 2|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 2||||ng/dL||Standard Deviation|Mean
1437077|NCT00957801|Primary|Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)|"Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL.~Baseline testosterone was drawn before testosterone administration."|treatment day 1||||ng/dL||Standard Deviation|Mean
1437078|NCT00957723|Secondary|Implant Survivorship||10 years|||||||
1437079|NCT00957723|Secondary|Patient Outcome Long Term Follow-up Questionnaire Over Time||6,7,8,9,10 years|||||||
1437080|NCT00957723|Secondary|Patellar Subluxation, Dislocation and Fracture Rate|The incidence of patellar subluxation, dislocation or fracture is reported.|5 years|Participants with available data.|||percentage of knees|knees||Number
1437081|NCT00957723|Secondary|Change in Lower-Extremity Activity Scale (LEAS) Over Time|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|preoperative, 1,2,3,4,5 years|Participants with available data: A total of 439 knees had a preoperative LEAS evaluation, 380 had 1 year, 304 had 2 year, 273 had 3 year, 222 had 4 year, and 201 had 5 year LEAS evaluations.|||units on a scale|knees|Standard Deviation|Mean
1437082|NCT00957723|Secondary|Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|preoperative,1,2,3,4 and 5 years|Participants with available data: Data for the WOMAC is only available at the 2,3,4 and 5 year intervals in limited numbers due to typographical errors noted on earlier interval forms rendering them invalid for comparison. One knee completed the validated WOMAC at 2 & 3 years, 51 at 4 years and 97 at 5 years.|||units on a scale|knees|Standard Deviation|Mean
1437083|NCT00957723|Secondary|Change in SF-36 Health Survey Over Time|The SF-36 Health Survey is a 36 item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|preoperative, 1,2,3,4,5 years|Participants with available data: A total of 433 knees completed a preoperative SF-36 evaluation, 379 completed a 1 year, 303 completed a 2 year, 270 completed a 3 year, 223 completed a 4 year, and 195 completed a 5 year SF-36 evaluation.|||units on a scale|knees|Standard Deviation|Mean
1437084|NCT00957723|Secondary|Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score|Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms.|1,2,5 years|Participants with available data: A total of 371 knees were assessed radiographically at 1 year, 313 at 2 years, and 199 at 5 years.|||Total number of knees|knees||Number
1437085|NCT00957723|Secondary|Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)|Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.|1,2,5 years|Participants with available data: A total of 386 knees had 1 year active flexion/extension measurements, 317 had 2 year, and 201 had 5 year active flexion/extension measurements.A total of 385 knees had 1 year passive flexion/extension measurements, 312 had 2 year, and 197 had 5 year passive flexion/extension measurements.|||degrees|knees|Standard Deviation|Mean
1437086|NCT00957723|Secondary|Change in Knee Society Score (KSS) Over Time|The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|preoperative, 1, 2, 5 years|Participants with available data: For the pain/motion sub-score 415 knees had a preoperative evaluation, 364 had a 1 year, 298 had a 2 year and 190 had a 5 year evaluation. For the function sub-score 440 knees had a preoperative evaluation, 385 had a 1 year, 309 had a 2 year and 203 had a 5 year evaluation.|||units on a scale|knees|Standard Deviation|Mean
1437087|NCT00957723|Primary|Active Range of Motion||2 Years|Per protocol|||Degrees|Knee Implants|Standard Deviation|Mean
1437088|NCT00957684|Primary|Part I: Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the intention-to-treat (ITT) population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.to a “frequency per 4 weeks” basis|12-week maintenance period|The primary efficacy analysis was based on the ITT population.|||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
1437089|NCT00957671|Secondary|Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|one year|This data is for the 5 female subjects enrolled in this study.|||percent of body fat||Standard Deviation|Mean
1437090|NCT00957671|Secondary|Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|baseline|This data is for the 5 female subjects enrolled in the study.|||percent of body fat||Standard Deviation|Mean
1437091|NCT00957671|Secondary|Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy|Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.|one year|This is the data for the 5 female subjects.|||kilograms||Standard Deviation|Mean
1437092|NCT00957671|Secondary|Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.|baseline|This data is for the 5 female subjects in the study.|||kilograms||Standard Deviation|Mean
1437093|NCT00957671|Secondary|Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This data is for the 5 female subjects in the study.|||kilograms||Standard Deviation|Mean
1437094|NCT00957671|Secondary|Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.|baseline|This data is for the 5 female subjects in the study.|||kilograms||Standard Deviation|Mean
1437095|NCT00957671|Secondary|Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy|Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This data represents the 5 females in the study.|||kilograms||Standard Deviation|Mean
1437096|NCT00957671|Secondary|Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.||baseline|This is the data for the 5 females in the study.|||kilograms||Standard Deviation|Mean
1437097|NCT00957671|Secondary|Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.|Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.|one year||||units on a scale||Standard Deviation|Mean
1437098|NCT00957671|Secondary|Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.|Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.|baseline||||units on a scale||Standard Deviation|Mean
1437099|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|one year|This data is for the 5 female subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
1437100|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|baseline|This data is for the 5 female subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
1437101|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy|Maximum torque production during isometric contraction of the knee extensor muscles.|one year|This data is for the 5 female subjects in the study.|||Newton-Meters||Standard Deviation|Mean
1437102|NCT00957671|Secondary|Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.|Maximum torque production during isometric contraction of the knee extensor muscles.|baseline|This data is for the 5 female subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
1437103|NCT00957671|Secondary|Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.|one year|This data is for the 10 male subjects in the study.|||percent of body fat||Standard Deviation|Mean
1437105|NCT00957671|Secondary|Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.|one year|This is the data for the 10 male subjects enrolled in the study.|||kilogram||Standard Deviation|Mean
1437106|NCT00957671|Secondary|Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.|baseline|This data is for the 10 male subjects enrolled in this study.|||kilograms||Standard Deviation|Mean
1437107|NCT00957671|Secondary|Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This data is for the 10 male subjects enrolled in the study.|||kilograms||Standard Deviation|Mean
1437108|NCT00957671|Secondary|Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline|Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|baseline|This data is for the 10 male subjects enrolled in this study.|||kilograms||Standard Deviation|Mean
1437109|NCT00957671|Secondary|Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.|Body mass was calculated from whole body scan taken using a GE Lunar iDEXA|one year|This is the data for the 10 male subjects in the study.|||kilograms||Standard Deviation|Mean
1437110|NCT00957671|Secondary|Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.|Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.|baseline|This data is for the 10 male subjects in the study.|||kilograms||Standard Deviation|Mean
1437111|NCT00957671|Secondary|Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.|Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.|one year||||Percent of Maximum Torque||Standard Deviation|Mean
1437112|NCT00957671|Secondary|Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.|Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.|baseline||||Percent of Maximum Torque||Standard Deviation|Mean
1437113|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|one year|This data is for the 10 male subjects in this study.|||Newton-Meters||Standard Deviation|Mean
1437114|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.|Maximum torque production during maximal isokinetic contractions at 90 degrees per second.|baseline|This data is for the 10 male subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
1437115|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.|Maximum torque production during isometric contraction of the knee extensor muscles.|one year|This is the data for the 10 male subjects in this study.|||Newton-Meters||Standard Deviation|Mean
1437116|NCT00957671|Secondary|Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.|Maximum torque production during isometric contraction of the knee extensor muscles.|baseline|This is the data for the 10 male subjects enrolled in this study.|||Newton-Meters||Standard Deviation|Mean
1437117|NCT00957671|Secondary|Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.|Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.|one year||||scores on a scale||Standard Deviation|Mean
1437118|NCT00957671|Secondary|Fatigue as Measured Using Fatigue Severity Scale at Baseline.|Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.|baseline||||scores on a scale||Standard Deviation|Mean
1437119|NCT00957671|Secondary|Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.|Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.|one year||||scores on a scale||Standard Deviation|Mean
1437120|NCT00957671|Secondary|Depression as Measured by the Beck Depression Inventory at Baseline.|Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0–13: minimal depression; 14–19: mild; depression; 20–28: moderate depression; 29–63: severe depression.|baseline||||scores on a scale||Standard Deviation|Mean
1437121|NCT00957671|Secondary|Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy|Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.|one year||||scores on a scale||Standard Deviation|Mean
1437345|NCT00955487|Primary|Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth Weight|Number of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)|Randomization to discharge||||Participants|||Count of Participants
1437122|NCT00957671|Secondary|Neuropsychological Function as Measured by Letter Fluency at Baseline|Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.|baseline||||scores on a scale||Standard Deviation|Mean
1437123|NCT00957671|Secondary|Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.|"Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.~This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work NO. Total correct responses for both task within 120 seconds are recorded.~Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome."|one year||||scores on a scale||Standard Deviation|Mean
1437124|NCT00957671|Secondary|Neuropsychological Function as Measured by Processing Speed Index at Baseline|"Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.~This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work NO. Total correct responses for both task within 120 seconds are recorded.~Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome."|baseline||||scores on a scale||Standard Deviation|Mean
1437125|NCT00957671|Secondary|Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.|Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.|one year||||scores on a scale||Standard Deviation|Mean
1437126|NCT00957671|Secondary|Neuropsychological Function as Measured by Digit Span Total at Baseline|"Digit Span; Wechsler Memory Scale III (WMS III).~Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome."|baseline||||scores on a scale||Standard Deviation|Mean
1437127|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|one year||||scores on a scale||Standard Deviation|Mean
1437128|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
1437129|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|one year||||scores on a scale||Standard Deviation|Mean
1437130|NCT00957671|Secondary|Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline|The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
1437346|NCT00955487|Primary|Combined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality|Number of participants that developed bronchopulmonary dysplasia and/or that died|Week 36 or earlier, if participants are discharged from the hospital||||Participants|||Count of Participants
1437131|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|One year||||scores on a scale||Standard Deviation|Mean
1437132|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
1437133|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|One year||||scores on a scale||Standard Deviation|Mean
1437134|NCT00957671|Secondary|Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.|The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.|baseline||||scores on a scale||Standard Deviation|Mean
1437135|NCT00957671|Primary|Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.|Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.|one year||||mL/beat||Standard Deviation|Mean
1437136|NCT00957671|Primary|Oxygen Pulse at Baseline.|Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.|baseline||||mL/beat||Standard Deviation|Mean
1437137|NCT00957671|Primary|Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.|Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|one year||||ratio of CO2/O2||Standard Deviation|Mean
1437138|NCT00957671|Primary|Respiratory Exchange Ratio at Baseline.|Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|baseline||||ratio of CO2/O2||Standard Deviation|Mean
1437139|NCT00957671|Primary|Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.|Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|one year||||L/minute||Standard Deviation|Mean
1437140|NCT00957671|Primary|Minute Ventilation at Baseline.|Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|baseline||||L/minute||Standard Deviation|Mean
1437141|NCT00957671|Primary|Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.|Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|one year||||mL/kg/min||Standard Deviation|Mean
1437142|NCT00957671|Primary|Maximum Oxygen Uptake at Baseline.|Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.|baseline||||mL/kg/min||Standard Deviation|Mean
1437143|NCT00957658|Secondary|Wrist DXA Scan Analysis|DXA is a bone densitometry scan that measures bone mineral density and assigns a T-score. This score shows the amount of bone a patient has compared with a young adult of the same gender with peak bone mass. A score above -1 is considered normal. A score between -1 and -2.5 is classified as osteopenia (low bone mass). A score below -2.5 is defined as osteoporosis.|5 years|Participants with available data: 107 hips had DXA scan T-scores at 5 years.|||T-score|hips|Standard Deviation|Mean
1437144|NCT00957658|Secondary|Acetabular Insert Wear|The linear wear rate of the polyethylene acetabular insert is measured radiographically and reported at 5 years.|5 years|Participants with available data: 97 hips were evaluated for wear rate at 5 years.|||millimeters per year|hips|Standard Deviation|Mean
1437145|NCT00957658|Secondary|PEQ (Patient Evaluation Questionnaire) Percent Achievement|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.~EXPECTATIONS KEY:~Participate in recreational activities (dancing,traveling,gardening)~Exercise or participate in sports~Independently perform household chores/daily routine~Easily change position,sit to stand/stand to sit~Remove need for cane crutch or walker~Use stairs normally step by step~Ability to sleep through night~Maintain social activites,caring for someone,playing with children~Use public transportation or drive~Maintain psychological well-being~Maintain sexual activity~Maintain employment"|6 months, 1 year, 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Participants select 3 expectations and assess percent achievement (100%,75%,50%,25%,or 0%) at 6 mos, 1 yr and 2 yrs.|||percentage of participants|hips||Number
1437146|NCT00957658|Secondary|PEQ (Patient Expectation Questionnaire) Overall Satisfaction|"The PEQ is a study sponsor generated outcomes form. It is a one page questionnaire completed by the participant to assess lifestyle recovery post-surgery. Preoperatively, participants are asked to identify 3 of 12 different expectations that they most want to achieve after hip surgery. At 6 months,1 year and 2 years post-surgery participants evaluated the 3 expectations they identified and assessed their overall satisfaction and percent achievement.~EXPECTATIONS KEY:~Participate in recreational activities (dancing,traveling,gardening)~Exercise or participate in sports~Independently perform household chores/daily routine~Easily change position,sit to stand/stand to sit~Remove need for cane crutch or walker~Use stairs normally step by step~Ability to sleep through night~Maintain social activites,caring for someone,playing with children~Use public transportation or drive~Maintain psychological well-being~Maintain sexual activity~Maintain employment"|6 months, 1 year and 2 years|Participants with available data: A total of 206 hips had 6 month data; a total of 203 hips had 1 year data; a total of 178 hips had 2 year data. Percentage of participants who were satisfied with the result is reported for each expectation at these intervals.|||percentage of particpants|hips||Number
1437147|NCT00957658|Secondary|Change in Lower Extremity Activity Scale (LEAS) Score|The change in LEAS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. The mean preoperative, 2 and 5 year scores are reported to assess improvement.|Preoperative, 2 and 5 years|Participants with available data: A total of 231 hips had a preoperative score, 181 had a 2 year, and 129 had a 5 year score.|||units on a scale|hips|Standard Deviation|Mean
1437148|NCT00957658|Secondary|Change in SF-12 Score|The change in SF-12 is reported by comparing the mean preoperative, 2 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Preoperative, 2 and 5 years|Participants with available data: A total of 217 hips had preoperative scores, 175 had 2 year and 121 had 5 year scores.|||units on a scale|hips|Standard Deviation|Mean
1437149|NCT00957658|Secondary|Change in Harris Hip Score (HHS)|The change in HHS is reported by comparing the mean preoperative, 2 and 5 year postoperative scores. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.|Preoperative, 2 and 5 years|Participants with available data: A total of 195 hips had a preoperative score, 174 had a 2 year score, and 117 had a 5 year score.|||units on a scale|hips|Standard Deviation|Mean
1437150|NCT00957658|Secondary|Revision/Removal Rates|The percentage (%) of hips with revision or removal of any total hip replacement component (acetabular cup, femoral stem or femoral head) is reported at the 2 and 5 year postoperative intervals.|2 and 5 years|Participants with available data: The revision/removal rate of any total hip replacement component at 2 years is reported for 182 hips/176 participants. The revision/removal rate of any component at 5 years is reported for 141 hips/136 participants.|||percentage of hips/any component revised|hip||Number
1437151|NCT00957658|Secondary|Percentage (%) of Hip Stems With Aseptic Loosening|Aseptic loosening is defined as a continuous radiolucency that surrounds the entire femoral stem porous coating-bone interface and that measures greater than 2 mm in thickness, and 5 mm or more of stem subsidence. Continuous radiolucency must be present in Zones 1, 2, 6 and 7 of the AP radiographic view and/or present in Zones 8, 9, 13 and 14 of the M/L radiographic view.|5 years|Participants with available data: 111 hips in 106 participants had a radiographic evaluation at 5 years.|||percentage of hips|hips||Number
1437152|NCT00957658|Primary|Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain||2 years||||percentage of hips|hips||Number
1437153|NCT00957593|Secondary|Perinatal Outcomes||24-72 hours|||||||
1437154|NCT00957593|Primary|Cesarean Delivery|Mode of delivery is the primary outcome|24-72 hours from admission for induction||||Cesarean deliveries|||Number
1437155|NCT00957580|Secondary|Part 2: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Up to 3 years|This outcome measure was not analyzed as the trial was terminated during safety run-in (Part 1).||||||
1437156|NCT00957580|Secondary|Part 1: Percentage of Subjects With Best Overall Response|The best overall response was reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) >1.0x10^9 per liter (/L), platelets >100x10^9 /L, bone marrow aspirate with less than or equal to (<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC >1.0x10^9/L, platelets >100x10^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (<) 5%. (4) Progressive disease (PD) = >50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = Subjects who failed to achieve CR, CRi or PR and without criteria for PD.|Day 29 of every alternate 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012|The efficacy analysis set included all subjects who received at least 1 administration of planned dose of pimasertib and had at least 1 efficacy assessment after the first dose. 'N’ (number of subjects analyzed)=subjects evaluable for this outcome measure.|||Percentage of Subjects|||Number
1437166|NCT00957580|Secondary|Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1437157|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
1437158|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib for Pimasertib 75 mg Reporting Arm:Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. 'N'(number of subjects analyzed)=subjects evaluable for this measure and n = subjects evaluable for the specified regimen."|||liter||Standard Deviation|Mean
1437159|NCT00957580|Secondary|Part 1: Apparent Oral Volume of Distribution (Vz/f) of Pimasertib:Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
1437160|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Multiple Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
1437161|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib for Pimasertib 75 mg Reporting Arm: Single Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure and n = subjects evaluable for the specified regimen."|||liter/hour||Standard Deviation|Mean
1437162|NCT00957580|Secondary|Part 1: Apparent Oral Clearance (CL/f) of Pimasertib: Single Dose|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. Data for Pimasertib 75 mg arm was not available for all the regimens combined, thus reported as separate outcome measure and not included in this outcome.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
1437163|NCT00957580|Secondary|Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Multiple Dose|The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1437164|NCT00957580|Secondary|Part 1: Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pimasertib: Single Dose|The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. It is obtained from AUC0-t plus AUCt-infinity.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘N’(number of subjects analyzed)=subjects evaluable for this measure.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1437165|NCT00957580|Secondary|Part 1: Area Under Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above Lower Limit of Quantification (AUC0-t) of Pimasertib: Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. ‘n =Subjects evaluable for this outcome measure for specified categories for each reporting group, respectively."|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1437289|NCT00955968|Secondary|Changes in Plasma Concentrations of Inflammatory and Thrombogenic Markers|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. This outcome required additional funding for laboratory testing which was not available and so this outcome is not reported.|Measured at baseline, after 4 and 12 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|||||||
1437167|NCT00957580|Secondary|Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Multiple Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
1437168|NCT00957580|Secondary|Part 1: Apparent Terminal Half-Life (t1/2) of Pimasertib: Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
1437169|NCT00957580|Secondary|Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3)|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. Number of subjects analysed refer to the subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
1437170|NCT00957580|Secondary|Part 1: Time to Reach Maximum Plasma Concentration (Tmax): Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided pharmacokinetic samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
1437171|NCT00957580|Secondary|Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Multiple Dose||Pre dose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post dose in Cycle 1 on Day 19 to Day 21 (Regimen 1 and 2) or Day 26 (Regimen 3).|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1437172|NCT00957580|Secondary|Part 1: Maximum Plasma Concentration (Cmax) of Pimasertib Single Dose||Predose 0.5, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, and 10.0 hours post-dose on Day 1 of cycle 1; Regimen 1, 2 and 3|Pharmacokinetic analysis set included all the subjects who received at least 1 dose of trial medication and provided adequate PK samples per protocol. N (number of subject analyzed) signifies subjects evaluable for this outcome measure.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1437173|NCT00957580|Secondary|Part 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Permanent Treatment Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs include both SAEs and non-SAEs.|Baseline up to 3 years|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Subjects|||Number
1437174|NCT00957580|Primary|Part 2: Percentage of Subjects With Best Overall Response|The best overall response was to be reported as either of the following: (1) Morphologic complete remission (CR) = normalization of the peripheral blood absolute neutrophil count (PBANC) >1.0x10^9 per liter (/L), platelets >100x10^9 /L, bone marrow aspirate with less than or equal to (<=) 5 percent (%) blasts, no blasts with Auer rods (AML only). (2) Complete remission with incomplete blood count recovery (CRi) = Same as CR without normalization of PBANC and platelet count. (3) Partial remission (PR) = normalization of PBANC >1.0x10^9/L, platelets >100x10^9/L, and at least a 50% decrease in the percentage of marrow aspirate blasts to 5-25%, or marrow blasts less than (<) 5%. (4) Progressive disease (PD) = >50% increase in peripheral blood or bone marrow blasts. (5) Stable disease (SD) = subjects who failed to achieve CR, CRi or PR and without criteria for PD.|Day 29 of every 29-day cycle until progression reported between day of first subject randomized, September 2009, until cut-off date, December 2012|Due to limited anti-leukemic effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed. Effects observed in the safety run-in part decision was made not to conduct part 2 hence this outcome measure was not assessed.||||||
1437175|NCT00957580|Primary|Part 1: Number of Subjects With Dose Limiting Toxicities (DLTs)|The DLT was any toxicity that resulted in treatment delay for more than (>) 2 weeks due to treatment-related adverse effects, or any Grade greater than or equal to (>=) 3 non-hematological toxicity excluding Grade 4 asymptomatic increases in liver function tests reversible within 7 days in subjects with liver involvement, and Grade 3 asymptomatic increases in liver function tests reversible within 7 days for subjects without liver involvement, Grade 3 vomiting unless encountered and persistent for more than 3 days despite adequate and optimal therapy, and Grade 3 diarrhea unless encountered and persistent for more than 3 days despite adequate and optimal anti-diarrhea therapy at any DL and judged to be possibly or probably related to the trial treatment by the Investigator and/or the Sponsor.|Baseline Up to Day 29 of Cycle 1|The DLT analysis set included all subjects who received over 90 percent (%) administration of trial medication in Cycle 1 or showed a DLT.|||subjects|||Number
1437176|NCT00957528|Secondary|9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines|Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months|5 months|All subjects who completed the protocol.|||pg/mL||Standard Deviation|Mean
1437290|NCT00955968|Secondary|Quality of Life|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. The analyses are planned to be completed by May 2019, after which results will be reported to ct.gov.|Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).||2019-10-31|10/2019||||
1437177|NCT00957528|Secondary|Changes in Serum Markers of Bone Turnover.|"Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include:~Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium"|5 months||||nM BCE (Bone Collagen Equivalents)||Standard Error|Mean
1437178|NCT00957528|Secondary|Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months|5 months||||gm/cm^2||Standard Error|Mean
1437179|NCT00957528|Primary|Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)|Lean body mass is expressed in grams as calculated by Hologic DEXA.|5 months|All subjects who successfully completed the five month protocol.|||grams||Standard Deviation|Mean
1437180|NCT00957528|Primary|Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months|Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).|5 months||||pounds||Standard Deviation|Mean
1437181|NCT00957528|Primary|Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months|The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-[ring-13C6]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = [(EP2 − EP1)/(EM•t)]•60•100, where EP1 and EP2 are the enrichments of bound L-[ring-13C6]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-[ring-13C6]-phenylalanine enrichment in the muscle intracellular pool.|5 Months|Subjects who completed the entire treatment protocol|||Percent per hour (%/hr)||Standard Deviation|Mean
1437182|NCT00957424|Primary|Number of Participants Willing to Continue With Preferred HRP||1 week follow up|Those who completed one-week multiple product sampling|||participants|||Number
1437183|NCT00957424|Primary|Number of Participants That Completed 1-week Trial||One week||||participants|||Number
1437184|NCT00957424|Primary|Number of Participants Willing to Try HRPs||Baseline||||participants|||Number
1437185|NCT00957424|Primary|Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)||Baseline||||participants|||Number
1437186|NCT00957372|Primary|PART II: Nº of Treatment-Emergent Adverse Events (TEAE)|The primary objective for Part II of the study was to evaluate the safety and tolerability of eslicarbazepine acetate (ESL, BIA 2-093) at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. Safety assessments were based primarily on AEs (Number of participants with at least one treatment-emergent adverse events are reported); assessment of AEs was based on treatment relatedness, action taken on study drug, outcome, and causality.|1-year|There was no sample size estimate for Part II. Part II was a 1-year open-label extension for patients who had completed Part I and was willing to continue treatment in Part II.|||participants|||Number
1437187|NCT00957372|Primary|Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on results for the ITT population during the 12-week maintenance period. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA model with treatment as a factor and seizure frequency as a covariate|12 weeks|The primary efficacy analysis was based on the ITT population.The intent-to-treat (ITT) population included all randomized patients with at least one dose of investigational product and at least one post-baseline seizure frequency assessment|||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
1437188|NCT00957333|Secondary|Urinary Bladder Capacity||1 day|||||||
1437189|NCT00957333|Primary|Substance Abuse Situation Record|Substance abuse situation record: ketamine|1 day||||years||Full Range|Mean
1437190|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The observed effect at 24 hours post-dose (E24) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||pmol/L||Standard Deviation|Mean
1437191|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The time to reach the maximum observed effect of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||hr||Full Range|Median
1437192|NCT00957268|Secondary|Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The maximum observed effect (Emax) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||pmol/L||Standard Deviation|Mean
1437224|NCT00957021|Secondary|Patient Outcome SF-36|The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state.|1,2,3,4 and 5 years|Maximum number of knees evaluated at any interval.|||units on a scale|knees|Standard Deviation|Mean
1437193|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of baseline-corrected glucagon-like peptide-1 was determined from the concentration-time curve. Baseline-corrected glucagon-like peptide-1 concentrations were calculated as the post-dose concentration at each post-dose time point minus the baseline (pre-dose) concentration.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||pmol•hr/L||Standard Deviation|Mean
1437194|NCT00957268|Secondary|Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The observed effect at 24 hours post-dose (E24) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||Percentage inhibition||Standard Deviation|Mean
1437195|NCT00957268|Secondary|Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The time to reach the maximum observed effect of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||hr||Full Range|Median
1437196|NCT00957268|Secondary|Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The maximum observed effect (Emax) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||Percentage inhibition||Standard Deviation|Mean
1437197|NCT00957268|Secondary|Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition|The area under the plasma effect-time curve from time 0 to 24 hours post-dose (AUEC[0-24]) of dipeptidyl peptidase-4 (DPP-4) inhibition was determined from the inhibition-time curve.|1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose|Pharmacodynamic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable DPP-4 inhibition or GLP-1 concentration.|||Percentage inhibition•hr||Standard Deviation|Mean
1437198|NCT00957268|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin|AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval in this study).|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.|||ng•hr/mL||Standard Deviation|Mean
1437199|NCT00957268|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.|||hr||Standard Deviation|Mean
1437200|NCT00957268|Primary|Cmax: Maximum Observed Plasma Concentration for Alogliptin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose|Pharmacokinetic set: All participants who received at least 1 dose of study drug and who had at least 1 measureable plasma concentration of alogliptin.|||ng/mL||Standard Deviation|Mean
1437201|NCT00957242|Secondary|Fibrin D-dimer Change From Baseline to 16 Weeks|Biomarker that measures biologic activities in patients as opposed to response.|maximum of 48 weeks||||mg/ml||Standard Deviation|Mean
1437202|NCT00957242|Secondary|Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) From Baseline to 16 Weeks|The DLCO measures the partial pressure difference between inspired and expired carbon monoxide.|Week 48 / Final Visit||||mL/min/mmHg||Standard Deviation|Mean
1437203|NCT00957242|Secondary|Total Score St. George's Respiratory Questionnaire (SGRQ)|The SGRQ is a quality of life measurement used to assess respiratory well being with a 0*-100 range (*indicates better health--lower is better).|Week 16 Change from Baseline|All participants per intention-to-treat|||score on a scale||Standard Deviation|Mean
1437204|NCT00957242|Secondary|Change in 6-minute Walk Distance (6MWD)|The 6MWD is a measure of exercise tolerance. Change in exercise tolerance is calculated at the latest time point (up to 48 weeks) minus the earliest time point (at baseline).|Change from baseline to last visit (maximum of 48 weeks)||||meters||Standard Deviation|Mean
1437205|NCT00957242|Secondary|Cardiovascular Mortality or Morbidity|Measured at 48 Weeks|maximum of 48 weeks||||events|||Number
1437206|NCT00957242|Secondary|Respiratory-related Hospitalizations||maximum 48 weeks||||events|||Number
1437207|NCT00957242|Secondary|Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF)||maximum of 48 weeks||||events|||Number
1437208|NCT00957242|Secondary|Bleeding Events||maximum of 48 weeks||||events|||Number
1437209|NCT00957242|Secondary|All-cause Hospitalizations||maximum 48 weeks||||events|||Number
1437210|NCT00957242|Secondary|Change in Forced Vital Capacity (FVC) From Baseline to 16 Weeks|Week-16 change from Baseline|16 weeks||||liters||Standard Deviation|Mean
1437211|NCT00957242|Secondary|All Cause Mortality||maximum of 48 weeks|All participants per intention-to-treat (ITT)|||events|||Number
1437212|NCT00957242|Primary|Death, Non-bleeding/Non-elective Hospitalization, or >10% Drop in Forced Vital Capacity|Death, non-bleeding/non-elective hospitalization, or >10% drop in forced vital capacity.|Events up to 48 weeks|All participants per intention-to-treat (ITT)|||events|||Number
1437213|NCT00957047|Primary|PART II - Nº of Treatment-Emergent Adverse Events (TEAE)|Safety assessments were based primarily on AEs (Number of patients who experienced at least one AEs), and on whether these were related to the study medication, were serious, led to permanent discontinuation of study participation, or led to death.|1 year||||participants|||Number
1437214|NCT00957047|Primary|PART I - Seizure Frequency|The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on the ITT population. Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study. The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.|12-week maintenance period|The primary efficacy analysis was an ANCOVA that assessed reduction in seizure frequency per 4 weeks for the ITT population during the 12-week maintenance period|||ln (Seizures) per 4 weeks||95% Confidence Interval|Least Squares Mean
1437215|NCT00957034|Secondary|Percent Change Physician Global Assessment of Heart Failure Status|Physician rates improvement or deterioration in heart failure: Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
1437216|NCT00957034|Secondary|Percent Change Patient Global Assessment of Heart Failure Status|Four global questions classifying improvement or deterioration in heart failure - Since your last clinic vist, has there been any change in activity limitation / symptoms / emotions / overall quality of life, related to your heart failure? Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
1437217|NCT00957034|Secondary|Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores|Minnesota Living with Heart Failure Questionnaire assessing how much heart failure affects life during previous month. Three scales measuring physical dimension (8 items, score 0-40), emotional dimension (5 items, score 0-25) and overall score (all 21 items, score 0-105). Eight separate items measure social & economic impairments included as part of overall score.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
1437218|NCT00957034|Secondary|Mortality or Hospitalizations|Composite endpoint - patients who were hospitalized or died during the trial.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Participants|||Number
1437219|NCT00957034|Secondary|Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification|Class I: Cardiac disease w/o limitation of physical activity. Class II: Cardiac disease resulting in slight limitation of physical activity. Comfortable at rest; ordinary activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Cardiac disease resulting in marked limitation of physical activity. Comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. Class IV: Cardiac disease resulting in inability to carry on any physical activity w/o discomfort. Symptoms present at rest. Any physical activity increases discomfort.|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change|||Number
1437220|NCT00957034|Primary|Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters|Measurement of distance walked as fast as possible on a hard flat pathway in six minutes|Baseline and Day 180|No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim.|||Percent Change||95% Confidence Interval|Least Squares Mean
1437221|NCT00957021|Secondary|Radiographic Outcome|Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.|1,2 and 5 years|Maximum number of knees evaluable at any interval.|||knees|knees||Number
1437222|NCT00957021|Secondary|Patient Outcome Lower-Extremity Activity Scale|The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis.|1,2,3,4 and 5 years|Maximum number of knees available at any interval.|||units on a scale|knees|Standard Deviation|Mean
1437223|NCT00957021|Secondary|Patient Outcome WOMAC|"The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.~Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison."|5 years|The number of knees evaluated at 5 years.|||units on a scale|knees|Standard Deviation|Mean
1437225|NCT00957021|Secondary|Patient Outcome Knee Society Score|The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as “excellent,” “good,” “fair,” or “poor,” a higher value represents a better outcome.|1,2 and 5 years|Maximum number of knees evaluated at any interval.|||units on a scale|knees|Standard Deviation|Mean
1437226|NCT00957021|Primary|Range of Motion|The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.|2 years|Participants can have both knees replaced. Range of motion is measured for each knee, as such the number of knees evaluated can be greater than the number of participants.|||degrees|Knees|Standard Deviation|Mean
1437227|NCT00957008|Secondary|Blood Fasting Glucose||Month 9|Last observation carried forward|||mg/dl||95% Confidence Interval|Least Squares Mean
1437228|NCT00957008|Primary|Waist Circumference||4 month||||cm||Standard Error|Least Squares Mean
1437229|NCT00957008|Primary|Body Weight||4 month||||kg||Standard Error|Least Squares Mean
1437230|NCT00957008|Primary|Body Weight|Body weight was assessed using a calibrated balance-beam scale.|nine month||||Kg||Standard Error|Least Squares Mean
1437231|NCT00957008|Primary|Waist Circumference|Waist circumference was measured at the level of the umbilicus with a plastic tape measure.|Month 9||||cm||Standard Error|Least Squares Mean
1437232|NCT00956943|Secondary|Side Effects|frequency of serious adverse events|8 weeks|intent to treat|||events|||Number
1437233|NCT00956943|Primary|Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment|quit rate verified with carbon monoxide breath sample (abstinence: less than or equal to 10ppm)|After 8 weeks of treatment with the patch, outcome will be measured.|intent to treat|||participants|||Number
1437234|NCT00956839|Secondary|Serum Total Calcium|Serum total calcium (mg/dL) at time points 0, 1, 3 and 6 months|0, 1, 3, 6 months post intervention|at time points 0, 1, 3 and 6 months|||mg/dL||Standard Deviation|Mean
1437235|NCT00956839|Primary|Percentage of Patients With Serum 25 Hydroxy Vitamin D3 > 30 ng/ml|Percentage of patients in each group with serum 25 hydroxy vitamin D >30 ng/ml|6 months post intervention|Intention to treat analysis|||percentage of patients||95% Confidence Interval|Number
1437236|NCT00956813|Secondary|Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)|The change of daily interference as measured by the HFRDIS from baseline to treatment termination between flaxseed versus placebo arms was evaluated with an independent t-test for continuous data. On a 0-10 scale, patients were asked to describe how hot flashes interfered with 10 different aspects of their life (work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life and overall quality of life). Scores were converted to a 0-100 scale where 100 is best QOL.The HFRDIS total score was the average of the 10 individual questions. The change in total score from baseline to end of treatment was analyzed between the groups using a Kruskal-Wallace test.|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
1437237|NCT00956813|Secondary|Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)|The change in quality of life as measured by the MENQOL from baseline to treatment termination between flaxseed versus placebo arms was evaluated. On a 0-6 scale, patients were asked to answer questions in in each of 4 domain scores (Vasomotor, Psychosocial, Physical, Sexual) Scores were converted to a 0-100 scale where 100 is best QOL. The change in score from baseline to end of treatment were analyzed separately for each domain. Here we report the mean change in score for each category.|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
1437238|NCT00956813|Secondary|Change of Mood as Measured by the Profile of Mood States (POMS)|"Profile of Mood States (POMS) was used to look at total mood disturbance as well as the subscales of tension-anxiety, fatigue-inertia, and vigor-activity. The POMS is a well known, well validated, reliable measure of psychological distress which includes 6 subscales of fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. The entire scale can be scored to provide a measure of total mood disturbance. The measure contains adjectives related to mood which are scored from 0 (not at all) to 4 (extremely). Individual scores were converted to a 0-100 scale where 100 is best quality of life.~The change of mood as measured by the POMS from baseline to treatment termination between flaxseed versus placebo arms was compared using Kruskal-Wallis test. The mean change in total score for each arm is reported."|Baseline and up to 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
1437239|NCT00956813|Secondary|Toxicity as Measured by CTCAE v3.0|Frequency and severity of adverse events were reported by patients weekly evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Up to 7 weeks|All patients treated during the Double-blinded period of the study were included in this analysis|||Participants|||Count of Participants
1437271|NCT00956293|Primary|Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437240|NCT00956813|Primary|To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.|"The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes.~The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7.~The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms."|Baseline and 7 weeks|Per protocol, the study was powered for 77 patients on each arm. With 20% over-accrual, the analysis began after 94 patients registered to each arm. 25 patients from Flaxseed were not used (4 cancel, 2 ineligible, 12 refused further treatment, 5 due to adverse events, 2 noncompliance). 17 from the placebo arm were not used (3,1,5,7,1 respective)|||units on a scale||Standard Deviation|Mean
1437241|NCT00956761|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0-3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.|||Number of participants|||Number
1437242|NCT00956761|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.|||Percentage of participants||95% Confidence Interval|Number
1437243|NCT00956761|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).~The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.|||Ratio||95% Confidence Interval|Geometric Mean
1437244|NCT00956761|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1437245|NCT00956709|Secondary|Duration of Sensory Sciatic Block (h)||72 hours||||hours||Full Range|Median
1437246|NCT00956709|Secondary|Duration of Motor Sciatic Block (h)||72 hours||||hours||Full Range|Median
1437247|NCT00956709|Secondary|Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.||72 hours|||||||
1437248|NCT00956709|Primary|Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot||72 hours|Two patients in each group had incomplete block before surgery.|||minutes||Full Range|Median
1437249|NCT00956657|Primary|CR Adherence|Number of cardiac rehabilitation classes attended in total.|Approximately 3-months after recruitment||||Classes Attended||Standard Deviation|Mean
1437250|NCT00956657|Secondary|Illness Perceptions Questionnaire-Revised Scores|Eight sub-scale scores obtained. Sub-scales include; Illness consequences, Illness Control, Treatment Control, Illness Identity, Emotional Representation, Illness Cause, Illness Coherence, Timeline Cyclical. Minimum and Maximum scores vary for each sub-scale.|3-months after consent|||||||
1437251|NCT00956631|Other Pre-specified|Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.|Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes & is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel & how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) & the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, & each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, & shows the broad impact which was of interest in this study.|Baseline and Six Months|All available participants were analyzed at six months.|||units on a scale||95% Confidence Interval|Mean
1437291|NCT00955968|Secondary|Medication Adherence|This secondary outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. The analyses are planned to be completed by May 2018, after which results will be reported to ct.gov.|Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).||2018-09-30|09/2018||||
1437252|NCT00956631|Other Pre-specified|Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.|Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. The questionnaire is divided into 10 topics including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation)to 5 (high pain or very limited physically) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).|Baseline and Six months|All available participants at Month 6.|||units on a scale||95% Confidence Interval|Mean
1437253|NCT00956631|Primary|Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at Month 6.|||units on a scale||95% Confidence Interval|Mean
1437254|NCT00956592|Secondary|Number of Particpants Requiring Adjuncts to Assist Intubation||1 year|Use of bougie or external manipulation|||Participants|||Count of Participants
1437255|NCT00956592|Secondary|Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.|Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved|1 year||||Participants|||Count of Participants
1437256|NCT00956592|Secondary|Number of Participants With Complications||1 year||||Participants|||Count of Participants
1437257|NCT00956592|Secondary|Number of Participants Intubated With a Rescue Device||1 year||||participants|||Number
1437258|NCT00956592|Secondary|Intubation Time|Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation|During laryngoscopy procedure|time|||seconds||90% Confidence Interval|Mean
1437259|NCT00956592|Primary|Measure of Intubation Success|Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure|During each intubation in a 14 month period|4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study|||Participants||95% Confidence Interval|Number
1437260|NCT00956540|Primary|Weaning Time|The weaning time starts at the first disconnection from mechanical ventilation lasting >30 minutes and ends after the patient tolerate 24 consecutive hours disconnected from mechanical ventilation.|6 months||||day||Standard Deviation|Mean
1437261|NCT00956540|Secondary|Tracheobronchitis and Pneumonia||6 months|||||||
1437262|NCT00956293|Secondary|Renal Function by Proteinuria||Months12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437263|NCT00956293|Secondary|Renal Function by GFR Over Time||Months 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437264|NCT00956293|Secondary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|Participants with adverse events (serious plus non-serious), serious adverse events and death were reported.|Months 6, 12, 24, 36, 48 and 60|Randomized Safety Set: This set included all randomized participants who received at least one dose of study medication.|||Participants|||Number
1437265|NCT00956293|Secondary|CD25 Saturation on Lymphocytes||Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437266|NCT00956293|Secondary|Evolution of Renal Function (Creatinine Slope)|The study was terminated prematurely and not powered for efficacy.|Week 7, Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437267|NCT00956293|Secondary|Occurrence of Treatment Failures|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437268|NCT00956293|Secondary|Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437269|NCT00956293|Secondary|Renal Function by Serum Creatinine|The study was terminated prematurely and not powered for efficacy.|Months 6, 12, 24, 36, 48 and 60|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437270|NCT00956293|Secondary|Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method|The study was terminated prematurely and not powered for efficacy.|Month 6|This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.||||||
1437335|NCT00955487|Other Pre-specified|Days in Hospital|Length of stay of participants|From birth to hospital discharge||||Days||Standard Deviation|Mean
1437272|NCT00956254|Secondary|AUC0-last of Fentanyl|AUC0-last is defined as the area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration of fentanyl, was calculated using the linear trapezoidal rule, and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic evaluable population: All subjects who had evaluable plasma profiles to calculate reliable estimates of pharmacokinetic parameters and who had no major protocol deviations.|||hr*ng/mL||Standard Deviation|Mean
1437273|NCT00956254|Secondary|Tmax of Fentanyl|Tmax is defined as the time to reach the maximum concentration of fentanyl in plasma and was determined from individual concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; and 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.|||hr||Standard Deviation|Mean
1437274|NCT00956254|Primary|Cmax of Fentanyl|Cmax is defined as the maximum drug concentration in plasma and was determined from individual plasma concentration versus time data. Blood samples for pharmacokinetic analysis were drawn pre-dose; 15 and 30 minutes; and 1, 2, 4, 6, 8, 10, and 12 hours post-dose. Fentanyl concentration assays were performed using a fully validated and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Results are reported for patients with and without mucositis.|Pre-dose to 12 hours post-dose|Pharmacokinetic (PK) population: All subjects who had evaluable plasma profiles to calculate reliable estimates of PK parameters and who had no major protocol deviations. One subject in the non-mucositis group self-administered a fentanyl product before receiving the study drug and was excluded from the PK population due to this protocol deviation.|||ng/mL||Standard Deviation|Mean
1437275|NCT00956085|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 6 weeks||||Participants|||Count of Participants
1437276|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 12 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 12 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
1437277|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 10 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 10 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
1437278|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 6 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 6 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
1437279|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 2 weeks after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 2 weeks.|||% spec.with>5 immature capillaries/HPF|||Number
1437288|NCT00955968|Secondary|Cost Effectiveness and Feasibility of Treatment Models|This outcome was intended as an exploratory analyses and was not included in the primary analyses. Given the results of the primary analyses and changes in WHO guidelines to recommend lifelong antiretroviral therapy, the protocol team decided that this outcome was no longer scientifically important. No resources and funding was allocated.|Measured at baseline, after 4 - 12 and 24 weeks, and then every 6 months until study termination. All participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|||||||
1437280|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 1 week after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 1 week.|||% spec.with>5 immature capillaries/HPF|||Number
1437281|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Vascularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal vascularity (as determined by the the number of specimen with greater than 5 immature capillaries per high powered field) after treatment with platelet rich fibrin matrix will be reported. Individual treated specimen were evaluated at 30 minutes after treatment, and the results used to determine the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant underwent biopsy of skin treated with platelet rich fibrin matrix at 30 minutes.|||% spec.with>5 immature capillaries/HPF|Participants||Number
1437282|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 12 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 12 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|12 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 12 weeks after treatment.|||%specimen with >25%new collagen/HPF|||Number
1437283|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 10 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 10 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|10 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 10 weeks after treatment.|||%specimen with >25%new collagen/HPF|||Number
1437284|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 6 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 6 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|6 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 6 weeks after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
1437285|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 2 Weeks After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 2 weeks after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|2 weeks after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 2 weeks after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
1437286|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 1 Week After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 1 week after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|1 week after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 1 week after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
1437287|NCT00956020|Primary|Qualitative Changes in Dermal and Sub Dermal Collagen and Cellularity 30 Minutes After Treatment With Platelet Rich Fibrin Matrix|Biopsy specimen will be obtained from PRFM treated skin, sectioned and stained with H&E. Qualitative differences from standard laboratory control specimen of normal untreated skin (not obtained from study participants) in dermal and sub dermal collagen (as determined by the number of specimen which had greater than 25% new collagen deposition per high powered field) 30 minutes after treatment with platelet rich fibrin matrix will be reported. The results were characterize the general qualitative changes and time frame for the effects of treatment.|30 minutes after treatment|Each participant will undergo biopsy of skin treated with platelet rich fibrin matrix, at 30 minutes after treatment.|||%specimen with >25%new collagen/HPF|Participants||Number
1437336|NCT00955487|Secondary|Sepsis|Number of participants that developed sepsis|Randomization to discharge||||Participants|||Count of Participants
1437337|NCT00955487|Secondary|Severe Intracranial Hemorrhage|Number of participants that developed severe intracranial hemorrhage (grade 3-4)|Randomization to discharge||||Participants|||Count of Participants
1437292|NCT00955968|Secondary|Number of Virologic Failure (VF) Participants With HIV Resistance in the Continue HAART Arm|VF was defined as two successive measurements of HIV-1 RNA above 1000 copies/ml at or after 24 weeks of HAART. HIV drug resistance was defined using the Stanford database (Version 6.2)|At time of confirmation of VF. HIV-1 RNA testing to identify VF was done at week 4, 12, 24, and every 12 weeks thereafter until study end at an average of 125 weeks. If HIV-1 RNA was above 1000 copies/ml, confirmatory testing was done within 4 weeks.|156 women who were VFs had antiretroviral drug resistance testing performed.|||Participants|||Count of Participants
1437293|NCT00955968|Secondary|Incidence Rate of Any Condition Outlined in Appendix II of Protocol or Death|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|||||||
1437294|NCT00955968|Secondary|Incidence Rate of Other Targeted Medical Conditions|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|||||||
1437295|NCT00955968|Secondary|Incidence Rate of Cardiovascular or Other Metabolic Events|This outcome was intended as an exploratory analyses and was not included in the primary analyses conditional on primary results and funding. Given the results of the primary analyses it was decided that this outcome was no longer scientifically important. No resources and funding was allocated.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|||||||
1437296|NCT00955968|Secondary|Incidence Rate of Grade 2 and Above Toxicity|The toxicity events included all grade 2 and higher hematology or chemistry events and grade 3 or 4 sign or symptoms. These events were graded using the Division of AIDS (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). The incidence rate was obtained by using the Kaplan-Meier method.|All laboratory measures were done at entry,4 and 12 weeks after, and then every 3 months until study end. Signs and Symtoms were recorded from study entry to study end. All were followed until July 7, 2015 (an average of 125 weeks of follow-up)|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437297|NCT00955968|Secondary|Incidence Rate of HIV/AIDS Related Events or WHO Clinical Stage 2 or 3 Events|HIV/AIDS related events or WHO Clinical Stage 2 or 3 events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437298|NCT00955968|Secondary|Incidence Rate of HIV/AIDS Related Events or Death|HIV/AIDS related events or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437299|NCT00955968|Secondary|Incidence Rate of HIV/AIDS Related Events|HIV/AIDS related events refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437300|NCT00955968|Secondary|Incidence Rate of Deaths|The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437301|NCT00955968|Secondary|Incidence Rates of Serious Non- AIDS Defining Cardiovascular, Renal or Hepatic Event|Serious non – AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437302|NCT00955968|Secondary|Incidence Rate of AIDS - Defining Illness|AIDS defining illness, refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437303|NCT00955968|Primary|Incidence Rates of AIDS - Defining Illness, Serious Non-AIDS Defining, Cardiovascular, Renal, Hepatic Event, or Death|AIDS defining illness, serious non–AIDS defining cardiovascular, renal, or hepatic event, or death refers to illness/diagnoses listed in Appendix II of the protocol. These events were reviewed and confirmed by an Endpoint review group. The incidence rate was obtained by using the Kaplan-Meier method.|From study entry to study termination, all participants were followed until July 7, 2015 (an average of 125 weeks of follow-up).|All participants except one who was excluded as she withdrew from study on the day she was randomized|||New cases per 100 person - years||95% Confidence Interval|Number
1437304|NCT00955955|Secondary|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|"This measure is a 16 item self report questionnaire assessing symptoms of depression. For each item, scores range from 0 to 3 with higher scores indicating greater impairment. To score this measure:~Enter the highest score from questions 1-4 (sleep items): ______~Enter score on item 5 ____~Enter the highest score from questions 6-9 (appetite/weight): ______~Enter score on item 10 ____~Enter score on item 11 ____~Enter score on item 12 ____~Enter score on item 13 ____~Enter score on item 14 ____~Enter the highest score from questions 15-16 (psychomotor items): ______~Total score range 0-27: ______~When assessing changes in this measure over time, negative means indicate an improvement (i.e. the scores decreased over time) and positive means indicate worsening in functioning."|Baseline and Day 60|Data presented is mean score reduction for the QIDS. The dataset of interest is limited to patients treated with placebo in phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone.|||Scores on a scale||Standard Deviation|Mean
1437305|NCT00955955|Primary|The 17-item Hamilton Depression Scale (HAM-D-17)|"The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68.~When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased)."|Baseline and Day 60|The phase II dataset of interest is limited to patients treated with placebo in phase I, completed phase I, did not experience a clinical response and entered phase II. Drug is compared to placebo in phase II for this subset alone. Some patients received Deplin in both phases of the study, but those patients are not included in these analyses.|||Scores on a scale||Standard Deviation|Mean
1437306|NCT00955916|Secondary|Median Overall Survival (OS)|Overall Survival is defined as the time from randomization until death from any cause.|Up to 3 years|All participants|||months||95% Confidence Interval|Median
1437307|NCT00955916|Secondary|Median Progression Free Survival (PFS)|Progression Free Survival is defined as the duration of time from start of treatment to time of progression. Leukemia related failure (progressive disease): Failure to induce bone marrow hypoplasia after 2 cycles or regrowth of leukemic blasts ≥ 20%.|Up to 3 years|All participants|||months||95% Confidence Interval|Median
1437308|NCT00955916|Primary|Overall Response Rate (ORR)|Overall Response Rate: Morphologic Complete Remission (CR) + Morphologic Complete Remission with incomplete blood count recovery (CRi) for evaluable participants. CR - Bone Marrow: < 5% blasts without Auer rods with at least 20% cellularity with maturation of all cell lines, No presence of unique phenotype by flow cytometry identical to what was found in the pretreatment specimen, No persistent dysplasia; Peripheral: normal blood counts, absolute neutrophil count (ANC) > 1.0 k/μl and platelets > 100 k/μl ANC > 1.0 k/μl and platelets > 100 k/μl (Peripheral blood counts documenting recovery can be utilized within 4 weeks of the bone marrow); No evidence of extramedullary leukemia. CRi - All CR criteria are met except for residual Neutropenia <1.0 x 10^9/L platelets < 100 k/μl.|8 weeks per participant|All participants|||percentage of participants|||Number
1437309|NCT00955903|Secondary|Weight Change/Maintenance|The change in body weight at follow up of 1 year. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year||||Kg||Standard Deviation|Mean
1437310|NCT00955903|Secondary|Cardiometabolic Risk Factors|We are reporting change in blood glucose. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year||||mg/dL||Standard Deviation|Mean
1437311|NCT00955903|Primary|Change in Abdominal Fat Mass|Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year|Baseline to 1 year||||Cubic cm||Standard Deviation|Mean
1437312|NCT00955877|Secondary|Number of Participants That Were Bradycardia Within 48hr Post Surgery|Number of participants that were bradycardia within 48hr post surgery|48hr post surgery||||Participants|||Count of Participants
1437313|NCT00955877|Secondary|Number of Participants That Were Given Zofran 48hr Post Surgery|Number of participants that were given Zofran 48hr post surgery|48hr post surgery||||Participants|||Count of Participants
1437314|NCT00955877|Secondary|Number of Participants That Were Given Codeine 48hr Post Surgery|Number of participants that were given codeine 48hr post surgery|48hr post surgery||||Participants|||Count of Participants
1437315|NCT00955877|Secondary|Number of Participants With Pruritis Within 48hrs Post op|Number of participants with pruritis within 48hrs post operation|48 hour post-operative period||||Participants|||Count of Participants
1437316|NCT00955877|Secondary|Number of Participants With Nausea and/or Vomiting 48hrs Post op.|Number of participants with nausea and or vomiting 48hr post surgery|48 hour post-operative period||||Participants|||Count of Participants
1437317|NCT00955877|Secondary|Number of Participants That Had Urine Retention for 48hrs Post Foley Catheter Removal.|Number of participants that had urine retention for 48hrs post foley catheter removal.|After the Foley catheter has been removed on post-operative day #1 for a 48 hour follow-up period||||Participants|||Count of Participants
1437318|NCT00955877|Secondary|Number of Participants With CSF Leaks Within 6 Months Post op.|Number of participants with CSF leaks within 6 months post operation.|6 month post-operative period||||Participants|||Count of Participants
1437319|NCT00955877|Secondary|Number of Participants With Hemodynamic Instability 48hrs Post op|Number of Participants with Hemodynamic Instability 48hrs post operation|48 hour post-operative period||||Participants|||Count of Participants
1437320|NCT00955877|Secondary|Number of Participants With Respiratory Depression Within 48hrs Post op|Number of participants with respiratory depression within 48hrs post operation|48 hour post-operative period||||Participants|||Count of Participants
1437321|NCT00955877|Primary|Quantity of Fentanyl Administered|Mean and standard deviation of total quantity of fentanyl administered (per patient per day) 48hrs post surgery.|48 hour post-operative period||||mcg||Standard Deviation|Mean
1437338|NCT00955487|Secondary|Threshold Retinopathy of Prematurity (ROP)|Threshold ROP defined as requiring interventional therapy|Randomization to discharge||||Participants|||Count of Participants
1437339|NCT00955487|Secondary|Symptomatic PDA Requiring Surgical Ligation|Number of participants with symptomatic PDA that required surgical ligation|Randomization through discharge||||Participants|||Count of Participants
1437322|NCT00955877|Primary|Adequacy of Analgesia as Judged by Age-adjusted Pain Scales|"Mean and standard deviation for standardized, age-appropriate pain scales (per patient per day) 48hrs post surgery. As is standard of care at St. Louis Children’s Hospital, pain level was scored based on age using the Face, Legs, Activity, Cry, Consolability (FLACC) for participants aged 0-3, the FACES scale on participants between the age of 3 and 5, numeric pain rating scale (NRS) on participants between the age of 5 and 8 years, or the Individualized Numeric Rating Scale (INRS) for participants greater than or equal to 8 years of age. All four of the scales were ranged from 0-10 scores, with 0 being no pain at all, and 10 being extreme pain. Each patient had two scores given, one at 24hrs and one at 48hrs post surgery. The output was reported as an average of all scores for all patients within each group."|48 hour post-operative period||||units on a scale||Standard Deviation|Mean
1437323|NCT00955825|Primary|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient’s daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.~The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).~The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 42.8 days)|The Full Analysis Set (FAS) includes all patients who received at least one dose of the investigational product and had at least one Combined Score while on treatment during the pollen period. The FAS was regarded as primary for the efficacy evaluations.|||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
1437324|NCT00955747|Primary|Change in Hemoglobin A1C Level From Baseline|The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.|1 year from baseline|Calculation of the final numbers for study completion considers a standard deviation of 1.4%, a two-sided 95% confidence interval (alpha= 0.025), power of 90%, and the ability to detect a 0.5% difference in HbA1c between treatment and placebo groups.|||percentage of change from baseline||Standard Error|Least Squares Mean
1437325|NCT00955721|Secondary|Phase II: Explore Biomarkers of Response to the Combination|A study of the correlation between biomarker levels and response to RPTD study therapy. Blood samples for biomarker analysis are collected at baseline and on day 1 of Cycles 2 onward|Baseline, Day 1 of Cycle 2 and subsequent cycles, about 9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
1437326|NCT00955721|Secondary|Phase II: Further Evaluate the Safety of the Proposed Combination|Rate of study participants experiencing toxicity after receiving study therapy at the recommended Phase 2 Dose (RPTD).|About 9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
1437327|NCT00955721|Secondary|Phase II: Estimate Overall Survival|Overall survival is defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact.|Start of treatment until death or date of last contact|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
1437328|NCT00955721|Secondary|Phase II: Estimate Overall Response Rate and Clinical Benefit Rate.|Overall response rate [CR + PR]. Clinical Benefit Rate [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD)] per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|About 9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the opening of Phase 2.||||||
1437329|NCT00955721|Primary|Phase II: Obtain an Estimate of the 9-month Progression-free Survival Rate in Patients With Advanced BTC Receiving the RPTD of the Combination Sorafenib and GEMOX.|Rate of study participants achieving progression-free survival at 9 months post-initiation of study therapy at RPTD. Progression-Free Survival (PFS) is defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.|9 Months|This was an outcome measure for the Phase 2 arm. Data were not collected due to the study's termination prior to the determination of the RPTD and the opening of Phase 2.||||||
1437330|NCT00955721|Primary|Phase I: Recommended Phase II Dose (RPTD) of the Combination of Sorafenib and GEMOX in Patients With Advanced Biliary Tract Cancer (BTC).|Establish the recommended phase II dose (RPTD) of the combination of sorafenib and GEMOX in patients with advanced biliary tract cancer (BTC).|First two 14-day Phase I cycles|A total of 9 participants were enrolled in Phase 1 of which 6 were evaluable and analyzed for this outcome measure. A recommended phase two dose (RPTD) of the combination of Sorafenib and GEMOX therapy could not be determined because dose escalation was still in progress when the study was terminated.|||mg|||Number
1437331|NCT00955617|Secondary|Signal Intensity|Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.|MRA examination||||Ratio||Standard Deviation|Mean
1437332|NCT00955617|Secondary|Diagnostic Confidence|"Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent.~Each image is analysed by 4 readers."|MRA examination|Descriptive study - No calculation|||Images|Participants||Number
1437333|NCT00955617|Primary|Overall Image Quality of MRA Images|"Number of images quoted with excellent and more than adequate quality in each group.~Image quality will be assessed on a 5-point scale:~Excellent~More than adequate~Adequate~Less than adequate~Non-diagnostic~Each image is analysed by 4 readers."|MRA examination|descriptive and pilot study, no number of participants calculation performed|||Images|Participants||Number
1437334|NCT00955513|Primary|Measure: Pain on Movement on Day 5 (Change From Baseline).|Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.|baseline and day 5||||mm||Standard Deviation|Mean
1437347|NCT00955474|Secondary|Blood Hemoglobin A1C at Baseline and Week 8.|Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||% glycated hemoglobin||Standard Deviation|Mean
1437348|NCT00955474|Secondary|LDL Blood Levels at Baseline and Week 8.|LDL levels at Baseline and Week 8. Normal range < 100 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
1437349|NCT00955474|Secondary|HDL Blood Levels at Baseline and Week 8.|HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
1437350|NCT00955474|Secondary|Blood Level of Triglycerides at Baseline and Week 8.|Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
1437351|NCT00955474|Secondary|Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.|Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||mg/dl||Standard Deviation|Mean
1437352|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.|RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437353|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.|RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437354|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.|RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437355|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.|RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437356|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score|RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437357|NCT00955474|Secondary|RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score|Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks.|8|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437424|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 32|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 32 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
1437358|NCT00955474|Secondary|CPFQ (Cognitive and Psychological Functioning Questionnaire)|Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437359|NCT00955474|Secondary|Fasting Blood Glucose|Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||ml/dl||Standard Deviation|Mean
1437360|NCT00955474|Primary|Psychosis|Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe.|8 weeks|Complete missing data for 2 subjects in the quetiapine with SSRI group (11 of 13 have baseline outcome measures). There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437361|NCT00955474|Primary|Depression|Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe.|8 weeks|Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.|||units on a scale||Standard Deviation|Mean
1437362|NCT00955357|Primary|"The Proportion of Subjects Who Achieved Seizure-free Status During the First 12 Weeks of the Maintenance Phase"|"A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.~This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn."|From Week 7 (end of Week 6) to end of Week 18|The Analysis Population refers to the Completer Set (CS) which includes all subjects who were enrolled, received at least one dose of Lacosamide and completed the first 12 weeks of the Maintenance Phase.|||percentage of subjects|||Number
1437363|NCT00955305|Secondary|Proportion of Patients With Objective Response|"Objective response was evaluated using the RECIST 1.1 criteria.~Objective response includes complete response (CR) and partial response (PR). Objective response is defined as disappearance of all target lesions or at least a 30% decrease in the sum of the diameters of target lesions. In addition, non-target lesions do not meet the criteria for disease progression and no new lesions were observed."|Assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry; up to 5 years|Eligible and treated patients|||Proportion of participants||95% Confidence Interval|Number
1437364|NCT00955305|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1437365|NCT00955305|Primary|Progression-free Survival (PFS)|"Progression-free survival was defined as the time from randomization to progression or death without documentation of progression. For cases without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurs within 3 months following the date last known progression-free, in which case the death was counted as a failure.~Progression was evaluated using RECIST 1.1 criteria and defined as:~At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.~OR~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
1437366|NCT00955279|Secondary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change is calculated as the value at week 28 minus the baseline value.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.|||percent of predicted FVC||Standard Error|Least Squares Mean
1437367|NCT00955279|Secondary|Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale|The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition.|Week 28|Secondary population included all the participants with chronic sarcoidosis with skin involvement who have received at least 1 dose of study medication.|||Percentage of Participants|||Number
1437368|NCT00955279|Secondary|Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1437369|NCT00955279|Secondary|Change From Baseline in 6-minute Walk Distance at Week 28|Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test.|Baseline (Day 1) and Week 28|mITT population included all the participants who were randomized and who received at least 1 dose of study medication.|||meters||Standard Error|Least Squares Mean
1437370|NCT00955279|Primary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16|Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change was calculated as the value at Week 16 minus the baseline value.|Baseline (Day 1) and Week 16|Modified intent-to-treat (mITT) population included all the participants who were randomized and who received at least 1 dose of study medication.|||percent of predicted FVC||Standard Error|Least Squares Mean
1437371|NCT00955266|Secondary|Length of ICU Stay (Days)|Intensive Care Unit length of stay in days.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
1437372|NCT00955266|Secondary|Length of Hospital Stay (Days)|Hospital length of stay in days.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
1437373|NCT00955266|Secondary|Need for Inotropic or Vasopressor Support Upon Leaving the OR|Use of inotropes or vasopressors in the Operating Room.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
1437374|NCT00955266|Secondary|Return to Cardiopulmonary Bypass Secondary to Hemodynamic Instability|Return to Cardiopulmonary bypass Yes/ No|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
1437375|NCT00955266|Primary|Diastolic Dysfunction|E/ A ratio on TEE. This ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) is reflective of degree of diastolic dysfunction.|64 enrolled patients or 9 months following start of protocol, whichever comes first|Data was in paper form only. Data storage location sustained significant water intrusion and mold contamination in June 2016. Environmental contractor has advised paper contents will need to be destroyed under containment conditions to ensure that mold does not spread. As a result, data is not available for results reporting.||||||
1437376|NCT00955110|Primary|High VAS - Emax (mm)|"The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar (I am feeling high). The ends of the line were marked with the descriptive anchors (Definitely not and Definitely so). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line."|High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.|Per Protocol population: Subjects who received all 5 treatments and who had no major protocol deviations or other circumstances that would exclude them from the analysis. The pharmacokinetic and pharmacodynamic analyses were performed using the Per Protocol population. No imputation of missing values was performed.|||mm||Standard Deviation|Mean
1437377|NCT00955032|Secondary|Hamilton Depression Rating Scale (HAM-D)|The Hamilton Depression Rating Scale (HAM-D) is a 24-item interviewer administered structure questionaire designed to assess symptoms of depression. Items are scored with a range of 0-4, though 11 of the items are scored between 0 and 2. A total score is then calculated of all items which can range from 0 to 74. A higher score is indicative of more depressive symptoms, and a lower score post-tx is indicative of better outcome.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
1437378|NCT00955032|Secondary|Beck Depression Inventory-Second Edition (BDI-II)|The Beck Depression Inventory-Second Edition (BDI-II) is a 21-item self-report questionaire that measures depressive symptoms. Each item is scored on a scale of 0-3, and items are summated to yield a total score. A higher score is indicative of greater symptoms of depression. Total scores may range between 0 and 63. A score greater than or equal of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
1437379|NCT00955032|Secondary|Lille Apathy Rating Scale (LARS)|The Lille Apathy Rating Scale (LARS) is a 33-item interviewer administered structured questionaire designed to assess level of apathetic symptoms. The first 3 items are scored from -2 to +2, while the remainder items are scored from -1 to +1. Scores can range between -36 to +36. The more positive the score, the greater level of apathy symptoms.|Pre-Tx; 10 days post-tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
1437380|NCT00955032|Primary|Apathy Evaluation Scale (AES)|The apathy evaluation scale is a 14-item self-report questionaire that provides a quantitative estimate of apathy symptoms. Items are given a score of 0-3, and a total score is summated using all items. Scores may range between 0 and 42. Higher scores are indicative of greater symptoms of apathy, and a score of 14 is suggestive of clinically significant symptoms.|Pre-Tx; 10 days post tx|All participants who completed study procedures were included for analyses.|||units on a scale||Standard Deviation|Mean
1437425|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 18|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 18 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
1437426|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 12|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 12 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
1437381|NCT00954993|Primary|Apparent Terminal Half-life (t-1/2) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the t-1/2 of vaniprevir. The t-1/2 is the time taken to eliminate half the amount of vaniprevir.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Since only a single liver sample timepoint was obtained from each participant at either 6 or 12 hours, and the 24 hour timepoint was not collected from any participant due to the early termination of the study, the t-1/2 could not be determined.||||||
1437382|NCT00954993|Primary|Concentration of Vaniprevir in the Liver|Participants were treated with vaniprevir on days, 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were collected at 6, 12, and 24 hours postdose to determine the concentration of vaniprevir in the liver.|6, 12 and 24 hours postdose on day 4 of each period (up to day 148)|Participants treated with vaniprevir who had a liver biopsy were analyzed as two separate groups that received 600 mg and 300 mg doses . No biopsies were collected at the 24 hour timepoint.|||nM||Full Range|Median
1437383|NCT00954993|Primary|Area Under the Curve (AUC) (0-12 Hrs) of Vaniprevir in the Liver|Participants were treated with vaniprevir twice daily on days 1,2, and 3. On treatment Day 4 participants were treated once with vaniprevir; then core needle liver biopsies were to be collected at 6, 12 and 24 hours postdose to determine the AUC of vaniprevir. AUC is the integrated area under the curve for plasma concentration of vaniprevir over time.|6, 12 and 24 hours postdose on day 4 of each period (up to Day 148)|Since only a single liver sample timepoint at either 6 or 12 hours was obtained from each participant, and no 24 hour timepoint was collected from any participant due to the early termination of the study, the AUC (0-12 hrs) was not calculated||||||
1437384|NCT00954941|Primary|Treatment Success Rate|Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.|||percentage of participants|||Number
1437385|NCT00954941|Primary|Participant Responses|Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.|First 6 treatment days|Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.|||participants|||Number
1437386|NCT00954915|Secondary|Teplizumab Blood Levels||Day 0 through Day 84|||||||
1437387|NCT00954915|Secondary|Physician's Global Assessment (PGA)|The PGA rates the subject’s psoriasis relative to baseline as 1 (100% clearing), 2 (excellent: 75% through 99% clearing with striking improvement), 3 (good: 50% through 74% clearing with moderate improvement), 4 (fair: 25% through 49% clearing with slight improvement), 5 (poor: 0% through 24% clearing with little or no change), or 6 (worsening). Involvement of body-surface area, induration, scaling, and erythema are taken into account.|Day 0, 14, 28, 63 and 84|||||||
1437388|NCT00954915|Secondary|Number of Participants Improved on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of plaque scale, erythema, and plaque induration (thickness) in each region, yielding an overall score of 0 for no psoriasis to a maximum of 72 for severe disease.|Day 0, 14, 28, 63 and 84|||||||
1437389|NCT00954915|Secondary|Number of Participants Improved on Lattice System Physician's Global Assessment (LS-PGA)|The LS-PGA score is determined by estimating the extent of body surface area involved by psoriasis and rating plaque qualities (elevation, erythema, scaling) averaged over the entire body. LS-PGA score is then determined using available software. LS-PGA ranks involvement on an 8 point scale from clear, almost clear, mild, mild to moderate, moderate, moderate to severe, severe, and very severe. Participants who have an improvement of one or more steps in the LS-PGA will be considered to have met the primary criteria for a clinical response.|Day 0, 14, 28, 63 and 84|||||||
1437390|NCT00954915|Primary|Adverse Events (AE)|Primary endpoints include safety data such as vital signs, physical examinations, electrocardiograms, AE reports, and laboratory test results.|Day 0 through Day 84|One subject was enrolled and followed per protocol. This subject's data are described in the adverse events summary.|||Participants|||Number
1437391|NCT00954824|Primary|The Primary Outcome Measure is Plasma Levels of TNF Alpha.||24 hours||||ng/mL||Standard Deviation|Mean
1437392|NCT00954733|Primary|TcCo2 vs PACo2 Difference|Evaluate the correlation between PaCO2- TcCO2 in detecting hypoventilation for patients undergoing deep sedation Absolute mean difference between TcCo2 and the PA Co2|1 hour||||mmHG||Standard Deviation|Mean
1437393|NCT00954707|Secondary|Rate of Non-cardiac Death|Include all deaths due to non-cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
1437394|NCT00954707|Secondary|Rate of Cardiac Death|Include all deaths due to cardiac causes.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
1437395|NCT00954707|Secondary|Rate of Protocol Defined Major Bleeding Complications|Defined by the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification, including severe and moderate bleeding combined.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
1437396|NCT00954707|Secondary|Rate of Academic Research Consortium (ARC) Defined Stent Thrombosis (ST)|ARC defined ST classifies ST by type – definite, probable, possible; by timing - acute, sub-acute, late, very late. Definite includes angiographic or pathologic confirmation; probable includes Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; Possible includes Any unexplained death > 30 days. Acute includes those ≤ 24 hours post procedure; sub-acute includes those > 24 hours to ≤ 30 days post procedure; and late includes those > 30 days to ≤ 1 year post procedure; and very late includes those > 1 year post procedure.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
1437397|NCT00954707|Secondary|Rate of Protocol Defined Stent Thrombosis (ST)|Protocol defined ST includes early and late ST. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave myocardial infarction, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
1437398|NCT00954707|Secondary|Rate of Major Adverse Cardiac Events (MACE)|MACE includes Death, myocardial infarction, emergent bypass surgery, or target lesion revascularization at 12 months|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).|||participants|||Number
1437399|NCT00954707|Secondary|Rate of Target Vessel Failure (TVF)|Defined as target vessel revascularization, recurrent infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).|||participants|||Number
1437400|NCT00954707|Secondary|Rate of Clinically Driven Target Vessel Revascularization (TVR)|Defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.|12 months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up).|||participants|||Number
1437401|NCT00954707|Secondary|Rate of Clinically-driven Target Lesion Revascularization (TVR)|Defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the subject has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis ≥50% by QCA.|12 Months|ITT Population patients with the specific event prior to end of follow-up plus patients without that event but with death or adequate follow-up (within 1 month prior to end of scheduled 12 months follow-up)|||participants|||Number
1437402|NCT00954707|Secondary|Rate of Procedure Success|Procedure success is defined as the achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, Myocardial infarction (MI), or repeat coronary revascularization of the target lesion during the hospital stay.|From post- procedure to hospital discharge, up to 39 days|Intent-to-Treat Population|||participants|||Number
1437403|NCT00954707|Secondary|Rate of Lesion Success|Lesion success is defined as the attainment of < 50% residual stenosis (by Quantitative coronary angiography (QCA)) using any percutaneous method.|From post- procedure to hospital discharge, up to 39 days|The total number of lesions the Intent-to-Treat population had at the beginning of the study|||Lesions|Participants||Number
1437404|NCT00954707|Secondary|Rate of Device Success|A study device success is defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used.|From post- procedure to hospital discharge, up to 39 days|The total number of devices the Intent-to-Treat patients used in the study.|||Devices|Participants||Number
1437405|NCT00954707|Primary|Phase I: the Rate of Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months.|12 months|Active subjects in the ITT population at 12-month post procedure|||participants|||Number
1437406|NCT00954681|Primary|Maximum Tolerated Dose of Quetiapine|Mean maximum tolerated dose of quetiapine|assesssed daily during 8 weeks of study, mean maximum tolerated dose reported|Mean maximum dose of quetipaine achieved|||milligrams||Full Range|Mean
1437407|NCT00954538|Primary|Least Squares (LS) Mean [18F]MK-3328 SUVR in Brain Posterior Cingulate Gyrus in AD Participants and HE Participants|Using PET brain images acquired after the second dose of [18F]MK-3328, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. Posterior cingulate gyrus SUVR was calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum.|60-90 minutes after second dose|All participants who received a second dose of [18F]MK-3328 in Part III of study|||ratio||95% Confidence Interval|Least Squares Mean
1437427|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 6|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 6 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
1437428|NCT00954447|Secondary|Number of Patients Lowering HbA1c by at Least 0.5 Percent||24 and 52 weeks|FAS (NCF)|||Participants|||Number
1437429|NCT00954447|Secondary|Number of Patients With HbA1c < 7.0 Percent||24 and 52 weeks|FAS using the non-completers considered failure (NCF) approach, in which missing data due to premature discontinuation of a patient were considered as failure.|||Participants|||Number
1437408|NCT00954538|Primary|Mean Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR) in AD Participants and HE Participants|Using PET brain images acquired after dosing, regions of interest (ROIs) were drawn in identified brain areas. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices).|60-90 minutes post dose|All participants who received [18F]MK-3328 in Part II of study|||ratio||Standard Deviation|Mean
1437409|NCT00954538|Primary|Organ Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, ROIs were drawn in all organs showing visible [18F]MK-3328 accumulation. TACs showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The organ effective dose is the equivalent dose in each organ multiplied by a weighting factor for the type of tissue exposed. The unit of organ effective dose is Sv.|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study|||µSv/MBq||Standard Deviation|Mean
1437410|NCT00954538|Primary|Effective Dose of [18F]MK-3328|Using PET whole body images acquired after dosing, regions of interest (ROIs) were drawn in all organs showing visible [18F]MK-3328 accumulation. Time activity curves (TACs) showing total [18F]MK-3328 retention as a function of time were determined for each organ. Residence times were calculated from the area under each organ TAC. Radiation exposure of the body and critical organs was calculated from the [18F]MK-3328 residence times using OLINDA (Organ Level Internal Dose Assessment) software. For each organ, the equivalent dose, which is the absorbed radiation dose weighted for the degree of the biological effect of different types of radiation, was calculated. The total radiation exposure to the body is expressed as the effective dose, which is the sum of the equivalent doses in each organ multiplied by a weighting factor for the type of tissue exposed. Effective dose is the primary surrogate for radiation risk. The unit of effective dose is the Sievert (Sv).|Up to approximately 6 hours post dose|All participants who received [18F]MK-3328 in Part I of study|||µSv/MBq||Standard Deviation|Mean
1437411|NCT00954538|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328|||participants|||Number
1437412|NCT00954538|Primary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug.|Up to 14 days after last dose|All participants who received [18F]MK-3328|||participants|||Number
1437413|NCT00954512|Primary|Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to this study drug. AEs may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (safety) consisted of all participants who received ≥1 dose of study drug.|||Participants|||Number
1437414|NCT00954512|Primary|Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response|Overall best response was determined by RECIST criteria. Types of overall response could be: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Assessable (NA) or Incomplete Response/Stable Disease (IR/SD).|Up to ~30 days after the final dose of robatumumab (Up to ~14 months)|The All Treated Set (efficacy) consisted of all participants who received ≥1 dose of study drug and were evaluable for this outcome measure.|||Participants|||Number
1437415|NCT00954447|Other Pre-specified|Number of Patients With HbA1c < 6.5 Percent||24 and 52 weeks|FAS (NCF)|||Participants|||Number
1437416|NCT00954447|Secondary|Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment||Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner|FAS (OC)|||mmol*hr/L||Standard Deviation|Mean
1437417|NCT00954447|Secondary|Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment|Mean Daily Glucose was calculated using the 8-point blood glucose profile|Baseline, 24 and 52 weeks|FAS (OC)|||mmol*hr/L||Standard Deviation|Mean
1437418|NCT00954447|Secondary|Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment|Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)|||International units (IU)||Standard Error|Mean
1437419|NCT00954447|Secondary|Change From Baseline in FPG||Baseline, 6, 12, 18, 24, 32 and 40 weeks|FAS, observed cases (OC)|||mg/dL||Standard Deviation|Mean
1437420|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment||Baseline and 52 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement|||mg/dL||Standard Deviation|Mean
1437421|NCT00954447|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment|Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs|Baseline and 24 weeks|FAS (LOCF), further restricted to patients with a baseline FPG measurement and at least one on-treatment FPG measurement|||mg/dL||Standard Error|Mean
1437422|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 52|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 52 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
1437423|NCT00954447|Secondary|Change From Baseline in HbA1c by Visit at Week 40|Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs|Baseline and 40 weeks|FAS (LOCF)|||Percentage||Standard Error|Mean
1437430|NCT00954447|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)|Baseline and 24 weeks|The Full Analysis Set (FAS) with a last observation carried forward (LOCF) approach. The FAS comprises all randomised patients who were treated with at least one dose of study medication, had a baseline HbA1c measurement, and had at least one on-treatment HbA1c measurement within the first 24 weeks of double-blind treatment.|||Percentage||Standard Error|Mean
1437431|NCT00954421|Secondary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Either VIM or VO On, and for Both VIM and VO Off (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.~Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline).~Either VO or VIM stimulator will be turned on (as opposed to both stimulators, as in outcome measure 1), and change in Tremor Rating Scale scores will be compared. The effects of each individual stimulator will also be compared to both being turned on."|Baseline to Six Months|Patients completing 6 months were tested for VIM and VO both on vs. both off. Score is TRS scale with both off minus both on. Positive value favors DBS.|||units on a scale||Standard Deviation|Mean
1437432|NCT00954421|Primary|Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Both VIM and VO ON (Baseline Minus 6 Months Post-implant)|"Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor.~Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline)."|Change from Baseline to Six Months|All Subjects completing Period 4|||units on a scale||Standard Deviation|Mean
1437433|NCT00954356|Secondary|Treatment Emergent Adverse Events|"Adverse Events were recorded at the time of occurence. Clinically significant findings (if any) in ECG and vital signs assessments and laboratory samples were recorded as adverse events.~Treatment Emergent Adverse Events (TEAEs) are those which either started or worsened following administration of study drug (XPF-001 or placebo)."|48 hours||||Events|||Number
1437434|NCT00954356|Secondary|Time to Rescue Medication|The time of administration of rescue medication (if any) was recorded for each subject and the duration since dosing was calculated.|24 hours||||Minutes||95% Confidence Interval|Median
1437435|NCT00954356|Secondary|Time to Meaningful Relief|"Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).~'Meaningful Relief' was defined as when the relief became 'meaningful' to each individual subject, and was not necessarily a complete absence of pain. 'Meaningful Relief' could not occur before 'First Perceptible Relief'."|24 hours||||Minutes||90% Confidence Interval|Median
1437436|NCT00954356|Secondary|Time to First Perceptible Relief|Onset of analgesia was measured using 2 stopwatches. Both stopwatches were started at the time of dose administration. Stopwatch 1 was pressed by the subject when any pain relief was first perceived (Time to First Perceptible Relief) and stopwatch 2 was pressed by the subject when pain relief became meaningful (Time to Meaningful Relief).|24 hours||||Minutes||95% Confidence Interval|Median
1437437|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID12 is an area calculation encompassing time and the PID scores over the 12 hours following dosing. The minimum possible SPID12 value = -120, the maximum possible = 120.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 12 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
1437438|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID8 is an area calculation encompassing time and the PID scores over the 8 hours following dosing. The minimum possible SPID8 value = -80, the maximum possible = 80.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 8 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
1437439|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID6 is an area calculation encompassing time and the PID scores over the 6 hours following dosing. The minimum possible SPID6 value = -60, the maximum possible = 60.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 6 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
1437440|NCT00954356|Secondary|Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose|"Pain intensity was scored on an 11-point scale (PINRS), (0=no pain - 10=pain as bad as you can imagine). Scores were measured at baseline (after surgery but before dosing) and at multiple timepoints after dosing. At each timepoint, pain intensity difference (PID) was calculated (ie, baseline score minus timepoint score).~SPID4 is an area calculation encompassing time and the PID scores over the 4 hours following dosing. The minimum possible SPID4 value = -40, the maximum possible = 40.~A positive SPID LS Means score implies reduced pain intensity over the corresponding time period."|Baseline to 4 hours post dose||||units on a scale||95% Confidence Interval|Least Squares Mean
1437485|NCT00953706|Secondary|Part B : Rate of Change From Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part B baseline through Week 64|Part B FAS.|||percent predicted of FEV1 per 336 days||Standard Error|Least Squares Mean
1437441|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 12 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 12-hour observation (TOTPAR 12); TOTPAR 12 is an area calculation incorporating time and relief scores over the 12 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 12 score = 0, maximum possible score = 48."|12 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
1437442|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 8 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 8-hour observation (TOTPAR 8); TOTPAR 8 is an area calculation incorporating time and relief scores over the 8 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 8 score = 0, maximum possible score = 32"|8 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
1437443|NCT00954356|Secondary|Total Pain Relief (TOTPAR) at 4 Hours Post Dose|"A secondary efficacy variable was total pain relief at the 4-hour observation (TOTPAR 4); TOTPAR 4 is an area calculation incorporating time and relief scores over the 4 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 4 score = 0, maximum possible score = 16)."|4 hours||||units on a scale||95% Confidence Interval|Least Squares Mean
1437444|NCT00954356|Primary|Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)|"The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule.~The higher the LS Means scores, the more pain relief was obtained.~Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 6 score = 0, maximum possible score = 24"|6 hours post dose|Published data from an impacted wisdom tooth removal was used to determine a 60 subject study with 2:1 randomisation and a one-sided significance level of 0.10 would have a power of 84.1%. LOCF was used for imputed values and all subjects were included in both the IIT and PP populations for analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1437445|NCT00954187|Primary|Decreased Overall Pain Score as Measured by the Visual Analogue Scale|No data was collected or analyzed. No study procedures were performed.|one month|No subjects were assigned treatment and no study procedures were performed||||||
1437446|NCT00954122|Secondary|Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.|"Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.~Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.~Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14).~This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on Outcome Measurement.|||Scores on a scale||Standard Deviation|Mean
1437447|NCT00954122|Secondary|Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale|"Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject’s mental. A reduction in score indicates an improvement in the subject’s condition. This assessment is based on the improvement since initiation of the study treatment.~Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-I score.|||Scores on a scale||Standard Deviation|Mean
1437448|NCT00954122|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)|"Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject’s mental illness. A reduction in score indicates an improvement in the subject’s condition. The CGI-S assessment should be based upon the subject’s symptoms during the previous week.~Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-S score.|||scores on a scale||Standard Deviation|Mean
1437449|NCT00954122|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Total score.|||Scores on a scale||Standard Deviation|Mean
1437486|NCT00953706|Secondary|Part B : Rate of Change From Part A Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Part A baseline through Week 64|Part B FAS.|||percent predicted of FEV1 per 448 days||Standard Error|Least Squares Mean
1441677|NCT00923260|Primary|Components of Metabolic Syndrome (Glucose)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mg/dl||Standard Deviation|Mean
1437450|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores|Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Positive score.|||Scores on a scale||Standard Deviation|Mean
1437451|NCT00954122|Secondary|Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.|"Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy.~Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19)."|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Negative score.|||Scores on a scale||Standard Deviation|Mean
1437452|NCT00954122|Primary|Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score|PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from ‘absent’ to ‘extremely severe’ (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.|Baseline and Day 21|ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS-EC score.|||Scores on a scale||Standard Deviation|Mean
1437453|NCT00954109|Primary|Blood Flow in Response to Oral Glucose Tolerance Tests|Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)|pre and 24 hours post 5-7 days of exercise||||percentage change||Standard Error|Mean
1437454|NCT00954109|Primary|Insulin Sensitivity After 5-7 Days of Exercise|Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).|baseline and 24h after 5-7 days of exercise||||index score||Standard Error|Mean
1437455|NCT00953927|Secondary|To Evaluate the QuantiFERON Conversion Rate at Final Study Assessment in MVA85A/AERAS-485 Recipients Compared to Controls in Infants Without a Diagnosis of Tuberculosis During the Trial.|The number (percentage) of infants with QuantiFERON conversions at any time on the study were summarized by treatment group.|15 to 36 months post-vaccination|Per protocol population who were quantiferon negative at baseline.|||participants|||Number
1437456|NCT00953927|Secondary|To Discover Correlates of Protection From Tuberculosis in Infants Vaccinated With MVA85A/AERAS-485.|Investigations for determining correlates of immune protection to TB will not be completed as planned because the study did not show TB protection in MVA85A/AERAS-485 recipients.|15 to 36 months post-vaccination|||||||
1437457|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the University of Capetown (UCT) Whole Blood Intracellular Cytokine Assay.|Frequencies of CD4 and CD8 T cells expressing cytokines (IFN-γ, IL-2 and TNF-α) following stimulation of whole blood with an Ag85A peptide pool were also measured by flow cytometry for a subset of infants.|28 days post-vaccination|Pre-specified population subset|||percentage of cytokine expressing cells||95% Confidence Interval|Median
1437458|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by the ex Vivo Enzyme Linked Immunospot (ELISPOT) Test Used in Previous MVA85A/AERAS-485 Human Trials.|An ex vivo IFN-γ ELISPOT assay was used to assess specific T cell responses to an Ag85A peptide pool for a subset of infants.|7 days post-vaccination|Pre-specified population subset|||SFC per million PBMCs||95% Confidence Interval|Median
1437459|NCT00953927|Secondary|To Evaluate the Immunogenicity of the MVA85A/AERAS-485 Vaccine Compared to Controls as Described by Flow Cytometric Intracellular Cytokine Staining of CD4 and CD8 T Cells.|Intracellular cytokine staining (ICS) assay immune response was expressed as the percentage of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T cells producing any one of three cytokines (IFN-γ, TNF-α, or IL-2) or any combination of the three cytokines simultaneously after stimulation with an Ag85A peptide pool on a subset of infants.|28 days post-vaccination|Pre-specified population subset|||percentage of cytokine expressing cells||95% Confidence Interval|Median
1437460|NCT00953927|Secondary|To Evaluate the Efficacy of the MVA85A/AERAS-485 Vaccine Compared to Controls in Prevention of Tuberculosis Using an Endpoint Derived From Epidemiological Cohort Surveys in BCG Vaccinated Infants.|The number (percentage) of subjects with a diagnosis of tuberculosis based on clinically-derived tuberculosis (TB) diagnostic criteria were summarized by treatment group for all subjects.|15 to 36 months post-vaccination|Per protocol population|||participants with a diagnosis of TB|||Number
1441678|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mmHg||Standard Deviation|Mean
1437461|NCT00953927|Primary|To Evaluate the Safety Profile of MVA85A/AERAS-485 in Bacillus Calmette-Guerin (BCG) -Vaccinated, HIV-negative Infants.|Adverse events (AE) were collected for 28 days after vaccination. The subject's parent or guardian recorded information regarding occurrences of solicited adverse events in diary cards through 7 days after vaccination. Serious adverse events (SAE) were collected from the time of study vaccine dosing throughout the entire study. A safety cohort (the first 330 infants enrolled) also had serum chemistry and hematology testing up to 28 days post-vaccination.|AEs recorded 28 days post-vaccination; SAEs recorded for entire study period.|All subjects vaccinated.|||percentage of all subjects vaccinated||95% Confidence Interval|Number
1437462|NCT00953862|Secondary|Change in Clinical Global Impression-- Severity of Illness Score|The CGI-S (Clinical Global Impression-- Severity of Illness) scale is a single-item rating scale of the clinician's assessment of the global severity of ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment|||units on a scale||Standard Deviation|Mean
1437463|NCT00953862|Secondary|Change in Adult ADHD Symptom Rating Scale v1.1 Symptom Checklist Score|The ASRS (Adult ADHD Symptom Rating Scale) v1.1 Symptom Checklist is an 18-item scale developed by the workgroup on Adult ADHD for the World Health Organization designed to assess the frequency of ADHD symptoms on a 0-4 scale (0 = never, 1 = rarely, 2 = sometimes, 3= often, and 4 = very often, minimum total summed score of 0 and maximum total summed score of 72, higher score is more impairment).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment|||units on a scale||Standard Deviation|Mean
1437464|NCT00953862|Primary|Change in Adult ADHD Investigator Symptom Rating Scale Score|The AISRS (Adult ADHD Investigator Symptom Rating Scale) consists 18-items that directly correspond to the 18 DSM-IV symptoms of ADHD. Each item is scored on a 4-point scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe, higher score is more impaired). The total summed score was at minimum 0 and at maximum 54 (the higher the score the more severe the symptomatology).|Baseline and week 10 of treatment|Those treated with atomoxetine who were not discontinued due to receiving less than 2 weeks of treatment|||units on a scale||Standard Deviation|Mean
1437465|NCT00953849|Primary|Change in IL-6 Levels.|Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
1437466|NCT00953849|Primary|Change in GM-CSF|Change in GM-CSF stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
1437467|NCT00953849|Primary|Change in IFN-gamma Levels|Change in IFN-gamma stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
1437468|NCT00953849|Primary|Change in IL-2 Levels|Change in IL-2 stimulatory cytokine levels within tumor tissue.|baseline and 3 weeks|Patients with head and neck squamous cell carcinoma.|||pg/100 gm protein||Standard Error|Mean
1437469|NCT00953745|Secondary|Depression Symptom Change on The Montgomery–Åsberg Depression Rating (MADRS) Scale Between ARP Responders and Non-responders.|Montgomery–Åsberg Depression Rating (MADRS) Scale scores compared between the 6 week Aripiprazole augmentation groups (responds vs. non-responders). Total range of the MADRS is 0 to 60, with a score of greater than 34 indicating severe depression, 20-34 indicating moderate depression, 7-19 mild depression, and 0-6 normal or absent of symptoms.|Week 10 and Week 16 (6 weeks of combined therapy)|MADRS score comparison between ARP responders and nonresponders.|||score on the MADRS scale||Standard Deviation|Mean
1437470|NCT00953745|Primary|Fluorodopa Uptake Values in Brain Images of Aripiprazole Augmentation Responders|A ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity specifically in a cluster within the right medial caudate (see data below).|Week 10 and Week 16 (6 weeks of combined therapy)|The outcome purpose was to examine mechanism of action of aripiprazole in responders versus nonresponders. Control subjects were age and gender matched to study subjects and underwent one set of scans (fMRI, raclopride and FOPA PET scans) for use as a comparison group for quality control on a non-depressed population and not for data analysis.|||FDOPA ratio in the right medial caudate||Standard Deviation|Mean
1437471|NCT00953719|Secondary|Proportion of Composite Successes|A subject was deemed to be a composite success at 24 months or greater if at the time of last clinical follow-up there had not been a revision of any THA components, the latest Harris Hip score was 80 or greater, and on the latest radiographic evaluation there were no radiolucencies greater than 2mm, no evidence of acetabular migration greater than 4mm, no change in acetabular shell inclination angle greater than 4 degrees, and no osteolysis.|At final follow-up visit, 24 months or later, up to 72 months|Per Protocol subjects with radiographic endpoints, and including subjects who have been revised (these are composite endpoint failures).|||percentage of participants|||Number
1437472|NCT00953719|Secondary|Harris Hip Score Longitudinal Analysis|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon, with a range of 0 to 100. Lower scores indicate a worse outcome and a score of 100 is the best possible outcome. Longitudinal analysis (repeated measures) was performed to compare post-operative Harris Hip sores over time.|6 week, 6 month, 12 month, 24 month, 36 month, and 48 months post-operatively|The population for this endpoint analysis is comprised of subjects who had Harris Hip scores at respective follow-up visits minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
1437473|NCT00953719|Secondary|Harris Hip Subscale Score: Range of Motion|The Harris Hip's Range of Motion subscale is a numeric value from 0 to 5. A lower score indicates a lower range of motion; a score of 5 indicates full range of motion.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
1437500|NCT00953615|Secondary|Soluble Tumor Necrosis Factor - Alpha|Assessment of effect from thalidomide on soluble tumor necrosis factor – alpha compared to baseline values were to be performed at study conclusion.|6 months, baseline||||pg/ml||Standard Deviation|Mean
1437474|NCT00953719|Secondary|Harris Hip Subscale Score: Deformity|The Harris Hip's Deformity subscale is a numeric value from 0 to 4. A lower score indicates more deformity; a score of 4 indicates no deformity.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
1437475|NCT00953719|Secondary|Harris Hip Subscale Score: Activities|The Harris Hip's Activities subscale is a numeric value from 0 to 14. A lower score indicates a lower ability to perform daily activities; a score of 14 indicates no limitations in daily activities.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
1437476|NCT00953719|Secondary|Harris Hip Subscale Score: Function|The Harris Hip's function subscale is a numeric value from 0 to 33. A lower score indicates less function; a score of 33 indicates no limitations in function level.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
1437477|NCT00953719|Secondary|Harris Hip Subscale Score: Pain|The Harris Hip's pain subscale is a numeric value from 0 to 44. A lower score indicates more pain; a score of 44 indicates no pain.|At final follow-up visit, 24 months or later, up to 72 months|The population for this endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Mean
1437478|NCT00953719|Primary|Total Harris Hip Score|The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. The Total Harris Hip Score is a sum of its subscores (Pain, Function, Activities, Deformity, and Range of Motion).|At final follow-up visit, 24 months or later, up to 72 months|The population for this primary endpoint analysis is comprised of subjects who completed the study with a Harris Hip score at final follow-up visit, 24 months or later, through 72 months, minus subjects who were found to have violated a protocol inclusion/exclusion criterion.|||units on a scale||Standard Deviation|Least Squares Mean
1437479|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events Per Participant Per Year|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.|||events per participant per year|||Number
1437480|NCT00953706|Secondary|Part B : Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.|||events|||Number
1437481|NCT00953706|Secondary|Part B : Number of Participants With Pulmonary Exacerbations|Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.|Part B baseline through Week 64|Part B FAS.|||participants|||Number
1437482|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Weight Through Week 64|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Deviation|Mean
1437483|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in Sweat Chloride Concentration Through Week 64|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
1437484|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in CFQ-R Respiratory Domain Score Through Week 64|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1437487|NCT00953706|Secondary|Part B : Absolute Change From Part A and Part B Baseline in ppFEV1 Through Week 64|ppFEV1 is defined in Outcome Measure 1.|Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64|Part B FAS included all participants who received at least 1 dose of study drug during Part B. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Deviation|Mean
1437488|NCT00953706|Secondary|Part A : Rate of Change From Baseline in Weight Through Week 16|As malnutrition is common in participants with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms per 112 days||Standard Error|Least Squares Mean
1437489|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Sweat Chloride Concentration Through Week 16|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1437490|NCT00953706|Secondary|Part A : Absolute Change From Part A Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 16|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.|Part A baseline through Week 16|Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
1437491|NCT00953706|Primary|Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16|Spirometry (as measured by ppFEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Knudson method.|Part A baseline through Week 16|Part A Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug during Part A. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Error|Least Squares Mean
1437492|NCT00953680|Primary|Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing|30 Hours Post Dose|Pharmacokinetic (PK) results were based on data from the 20 subjects who had blood drawn for the HCTZ assay. These 20 subjects were selected as the first 10 subjects from each treatment sequence who completed both periods of the study.|||ng/mL||Standard Deviation|Least Squares Mean
1437493|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of HCTZ|Plasma Area Under the Curve, a measure of drug exposure following dosing|0 to 30 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.|||ng*hr/mL||Standard Deviation|Least Squares Mean
1437494|NCT00953680|Primary|Peak Plasma Concentration (Cmax) for Losartan|Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.|36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.|||ng/mL||Standard Deviation|Least Squares Mean
1437495|NCT00953680|Primary|Area Under the Curve (AUC(0 to Infinity)) of Losartan||0 to 36 Hours Post Dose|Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.|||ng*hr/mL||Standard Deviation|Least Squares Mean
1437496|NCT00953667|Secondary|Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender||Baseline ( −15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of C-Reactive Protein (CRP).|||mg/L||Inter-Quartile Range|Median
1437497|NCT00953667|Primary|Baseline and Peak TNF-alpha Values as Categorized by Race and Gender||Baseline (−15 min, −5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS|This analysis population was categorized by race and gender as follows: European American (EA) male n=102, African American (AA) male n=41, EU female n=91, and AA female n=60. Results include measurements at baseline and peak levels of Tumor Necrosis Factor- alpha (TNF-alpha).|||pg/ml||Inter-Quartile Range|Median
1437498|NCT00953654|Primary|Worry Symptoms|"Worry symptoms, hallmark symptoms of GAD, were assessed using the Penn State Worry Questionnaire (PSWQ). The PSWQ is a 16-item self-report questionnaire that measures pathological worry symptoms. Participants rate items from 1 not at all typical of me to 5 very typical of me. Scores range from 16 to 80, with higher scores indicated exacerbated worry symptoms. Symptoms were assessed at baseline and at the beginning of the second weekly session during weeks 2, 4, and 6."|Baseline, Week 2, Week 4, Week 6||||Units on a scale (PSWQ)|Participants|Standard Deviation|Mean
1437499|NCT00953654|Primary|Generalized Anxiety Disorder (GAD) Remission as Measured by Anxiety Disorders Interview Schedule-Adult Version (ADIS-IV) Severity Ratings|GAD is characterized by persistent excessive or pathologic worry most days for at least 6 months about activities of daily life that is difficult to control and associated with at least 3 of the following symptoms: restlessness, feeling on edge, being easily fatigued, difficulty concentrating, irritability, muscle tension, and sleep difficulty. Symptoms are not caused by a substance or disorder, but cause significant distress or functional impairment. Remission was measured using the ADIS-IV from 1-16 days following the 6-week intervention.|Pre- and post- 6 week training intervention||||Participants|||Number
1437502|NCT00953615|Secondary|Overall Toxicity and Tolerability|Overall toxicity and tolerability were to be measured by the number of patients with development of neuropathy, increased liver biochemistries, drowsiness, dizziness and orthostatic hypotension.|6 months||||participants|||Number
1437503|NCT00953615|Primary|Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase|The primary outcome was the change in serum liver biochemical parameter levels after 6 months of thalidomide when compared to baseline values. This was to be analyzed using the nonparametric Wilcoxon signed rank test of significance. This was based on the non-normal distribution of serum hepatic biochemical parameters among patients with PSC and the continuous nature of these variables.|6 months, baseline|Analysis was not performed because participant did not complete the study due to adverse events.|||IU/L||Standard Deviation|Mean
1437504|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1437505|NCT00953524|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1437506|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1437507|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.|||Participants|||Number
1437508|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.|||Participants|||Number
1437509|NCT00953524|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1437510|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.|||Participants|||Number
1437511|NCT00953524|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population.|||Participants|||Number
1437512|NCT00953407|Primary|Lens Awareness|Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.|4 weeks of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||Participants|||Number
1437513|NCT00953329|Primary|Treatment Alefacept|Terminated study|12 weeks (study terminated)|Study terminated||||||
1437514|NCT00953290|Primary|Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment||||cm|Participants|Standard Deviation|Mean
1437515|NCT00953290|Secondary|Adverse Events||At each visit (treatment and follow-up) or until resolution of AEs||||Event|Participants||Number
1437516|NCT00953290|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment|Data was not collected due to termination.|||Participants|||Number
1437517|NCT00953290|Primary|Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms|Mean difference of change from baseline between two arms: [Treated arm - Untreated arm]|Baseline and 6 months post final treatment||||cm|Participants|Standard Deviation|Mean
1437518|NCT00953225|Secondary|Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment|Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.|1 year|Each subject had 12 cores measured at each of the pre and post prostate biopsies. The variable summarized is the number of positive cores per subject.|||cores per subject||Inter-Quartile Range|Median
1437519|NCT00953225|Primary|PSA Slope (Trajectory) or the Change in PSA Level Over Time|Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.|1 year (visits # 1-8)|Linear regression was applied to each subject's data with Log(PSA +1) as the outcome. Based on the fitted model, the change in PSA from visit #1 (baseline) to visit #8 (1 year) was calculated. This derived change score is summarized by group.|||ng/mL||Inter-Quartile Range|Median
1437520|NCT00953212|Secondary|Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation||30 days||||Participants|||Count of Participants
1437531|NCT00953212|Primary|Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery|Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost. This prospective, randomized trial used a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers would decrease the incidence of postoperative AF in adult cardiac surgery when compared with beta blockers alone, all combinations failed to show any difference between the four groups. While there have been trials that have shown the addition of amiodarone to beta-blockers to be more effective, this analysis does not support that conclusion.|5 postoperative days|Number of patients who experienced Atrial Fibrillation post-operatively|||Participants|||Count of Participants
1437532|NCT00953199|Secondary|Serum Amylase Levels|serum amylase levels are measure by a blood draw|measurement is taken 2 hrs after ERCP||||units/liter||Full Range|Mean
1437533|NCT00953199|Primary|Post ERCP Pancreatitis is the Primary Outcome.|The primary outcome of interest will be development of acute pancreatitis defined as new or worsening abdominal pain post-ERCP associated with an increase in serum amylase at least 3 times the upper limit of normal.|24-48 hours post-procedure||||participants|||Number
1437534|NCT00953173|Primary|%TBWL|Percent of total body weight change.|5 years|Patients who attended 5 year visit.|||% TBWL||Standard Deviation|Mean
1437535|NCT00953160|Secondary|The Number of Participants With Adverse Events|At each visit (treatment and follow-up) or until resolution of AEs|Up to 6 months after the last treatment||||Participants|||Number
1437536|NCT00953160|Secondary|Subject Satisfaction||Baseline and 6 months post final treatment|||||||
1437537|NCT00953160|Primary|Change in Circumference (cm)||Baseline and 6 months post final treatment||||Centimeters (cm)||Standard Deviation|Mean
1437538|NCT00953147|Secondary|Change From Baseline to Month 6 (Week 26) in RQLQ(S) Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0.|RQLQ(S) scores in impaired subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S)consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 26|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437539|NCT00953147|Secondary|Change From Baseline to Week 6 in Rhinoconjunctivitis Quality of Life Questionnaire With Standardized [RQLQ(S)] Overall Score in Impaired Patients With Baseline RQLQ(S) Score ≥3.0|RQLQ(S) scores in subjects with baseline RQLQ[S] score ≥3.0. RQLQ(S) consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Baseline and Week 6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437540|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437541|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population.|||units on a scale||Standard Error|Least Squares Mean
1437542|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437543|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM & PM rNSS Averaged Over the First 6 Weeks of Double-blind Treatment Period.|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437544|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437545|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the First 6 Weeks of the Double-blind Treatment|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437546|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437547|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all participants analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437548|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437549|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the First 6 Weeks of Double-blind Treatment.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437550|NCT00953147|Secondary|Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS (iTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437551|NCT00953147|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS (rTNSS) Averaged Over the First 6 Weeks of Double-blind Treatment|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0-6|Intent to Treat Population. Not all subjects analyzed due to missing data.|||units on a scale||Standard Error|Least Squares Mean
1437552|NCT00953121|Secondary|Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin|Number of patients experiencing a toxicity greater than or equal to grade 2 treatment-related toxicity|34 months||||participants|||Number
1437553|NCT00953121|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|40 months||||months||95% Confidence Interval|Median
1437554|NCT00953121|Secondary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|40 months||||months||95% Confidence Interval|Median
1437587|NCT00952731|Secondary|Difference in Factor IX Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor IX coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage of Factor IX protein in blood||Standard Deviation|Mean
1437555|NCT00953121|Secondary|Objective Response Rate|Percentage of participants with an objective response (complete response or partial response) based on Response Assessment in Neuro-Oncology (RANO) criteria. A complete response is defined as disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. A partial response is defined as greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.|34 months|The number of participants analyzed is lower than the total number in the study for each arm due to the fact that some patients progressed or experienced an adverse event which resulted in being taken off study during the first cycle and thus were never evaluated for radiographic response.|||participants|||Number
1437556|NCT00953121|Primary|6 Month Progression-free Survival|Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.|6 months||||percentage of participants||95% Confidence Interval|Number
1437557|NCT00953056|Secondary|Number of Infants With Fecal Vaccine Virus Shedding|Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.|Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo|Only participants in Cohort III, infants that received the scheduled dose of vaccination, and for whom the stool samples were available for testing, were included in the analysis for that dose.|||Participants|||Number
1437558|NCT00953056|Primary|Number of Serious Adverse Events|The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.|14 days post vaccination||||Events|||Number
1437559|NCT00953056|Primary|Number of Participants With Serious Adverse Events|All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.|up to 14 days post vaccination||||Participants|||Number
1437560|NCT00953043|Secondary|Median Pressure When Pain Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3||||mm Hg||Full Range|Median
1437561|NCT00953043|Secondary|Median Pressure When Gas Sensation Was First Reported by 50% of Participants|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3||||mm Hg||Full Range|Median
1437562|NCT00953043|Secondary|Median Pressure When First Sensation Was Reported by 50% of Participants|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mmg Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 45 min after colonic tube placement, on Day 3||||mm Hg||Full Range|Median
1437563|NCT00953043|Secondary|Gas Sensation Ratings in Response to Colonic Distensions at 32 mm Hg Above Baseline Operating Pressure|Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no gas sensation and 100 mm for extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas sensation.|approximately 1 hour after colonic tube placement, on Day 3||||mm||Standard Error|Mean
1437564|NCT00953043|Primary|Pain Sensation Ratings in Response to Colonic Distension at 32 mm HG Above Baseline Operating Pressure|Pain was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|approximately 1 hour after colonic tube placement, on Day 3||||mm||Standard Error|Mean
1437565|NCT00953043|Primary|Postprandial Colonic Tone|Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after standard meal, on Day 3||||mL||Standard Error|Mean
1437566|NCT00953043|Primary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon).|30 minutes after the colonic tube placement, on Day 3||||mL||Standard Error|Mean
1437567|NCT00953043|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.~After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after third dose of lubiprostone or placebo, on Day 3||||mm Hg||Standard Error|Mean
1437568|NCT00953017|Secondary|Polyps Detected|Number of polyps|measured at the time of colonoscopy||||polyps|||Number
1437569|NCT00953017|Secondary|Procedure Time|total colonoscopy procedure time|measured at the time of colonoscopy||||minutes||Standard Deviation|Mean
1437571|NCT00953017|Primary|The Cleanliness of the Prep as Measured by the Ottawa Scale|Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.|measured at the time of colonoscopy||||Ottawa Scale||Full Range|Mean
1437572|NCT00952848|Secondary|Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument|Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days|||units on a scale||90% Confidence Interval|Median
1437573|NCT00952848|Secondary|Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy|The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention|2 weeks|Patients treated with MC5A devise for 10 consectuvive days|||mg/24hr||90% Confidence Interval|Median
1437574|NCT00952848|Secondary|Effect of MC5-A on Pain and Neuropathy|Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged.|2 weeks|Patients treated with MC5A devise for 10 consectuvive days|||units on a scale||90% Confidence Interval|Median
1437575|NCT00952848|Primary|Change in Pain Score|"Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15.~Scale is 0 (none) to 10 (severe)"|15 days|Patients treated with MC5A devise for 10 consectuvive days|||units on a scale||90% Confidence Interval|Median
1437576|NCT00952822|Secondary|Infusion Site Pain|Pain was assessed by participants (≥5 years of age) on a visual analog scale (VAS) from 0 (no pain) to 100 (worst possible pain).|Within 5 minutes post-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion|||Scores on a scale||Full Range|Median
1437577|NCT00952822|Secondary|Number and Severity of Infusion Site Reactions|Infusion-related local reactions (including pain, tenderness, erythema, induration, and bruising) and severity were evaluated according to an FDA-defined grading scale (FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials; 2007).|Within 5 minutes pre-infusion up to 24 hours post-infusion|Participants who received at least 1 infusion|||Participants|||Number
1437578|NCT00952822|Secondary|Maximum Plasma Concentration|Maximal factor VIII concentration post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||IU/dL||Standard Deviation|Geometric Mean
1437579|NCT00952822|Secondary|Volume of Distribution at Steady State|Computed as weight-adjusted clearance * mean residence time|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||dL/kg||Standard Deviation|Mean
1437580|NCT00952822|Secondary|Mean Residence Time|Computed as total area under the moment curve divided by the total AUC. Total area under the first moment curve (AUMC) estimated by linear trapezoidal methods|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||hours (h)||Standard Deviation|Mean
1437581|NCT00952822|Secondary|Weight-Adjusted Clearance|Computed as the weight-adjusted dose divided by total AUC|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||mL/(kg*h)||Standard Deviation|Mean
1437582|NCT00952822|Secondary|Terminal Half-life|Computed from the regression slope in the terminal phase of the model. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%.|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Per Protocol|||hours||Standard Deviation|Mean
1437583|NCT00952822|Secondary|Adjusted in Vivo Incremental Recovery|Increase in factor VIII concentration from pre- to post-infusion|Pharmacokinetic evaluations: 30 minutes pre-infusion to 30 minutes post-infusion|Intent to Treat|||IU/dL:IU/kg||Standard Deviation|Geometric Mean
1437584|NCT00952822|Secondary|Total Area Under the Curve|Total AUC when the concentration is extrapolated to zero using the slope of the β-phase of the model|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (intent to treat) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.|||IU*h/dL||Standard Deviation|Geometric Mean
1437585|NCT00952822|Primary|Area Under the Curve|Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method|Pharmacokinetic evaluations: 30 minutes pre-infusion up to 48 hours post-infusion|Number of complete crossover participants (per protocol) who received the assigned sequence of 2 infusions: reconstituted in 2mL then 5mL SWFI or in 5mL then 2mL SWFI.|||IU*h/dL||Standard Deviation|Geometric Mean
1437586|NCT00952731|Secondary|Difference in Protein S Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between protein S coagulation protein in blood samples collected at baseline and before surgery was measured using an ELISA Kit.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage of protein S in blood||Standard Deviation|Mean
1437717|NCT00951912|Secondary|Total Energy Intake at Follow-up|The energy intake was evaluated by 3 days dietary records.|an average of the 24 weeks follow-up period which were evalutated on baseline,12 week and 24 week.|The number of participants for analysis was determinted by intention to treat|||kcal||Standard Deviation|Mean
1437588|NCT00952731|Secondary|Difference in Factor VIII Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between Factor VIII coagulation protein in blood samples collected at baseline and before surgery was measured with VisuLize antigen ELISA Kits.|Baseline and immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage Factor VIII protein in blood||Standard Deviation|Mean
1437589|NCT00952731|Other Pre-specified|E and Z 4-OHT Isomers|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
1437590|NCT00952731|Secondary|Difference in vWF Coagulation Protein in Blood Collected at Baseline and Just Prior to Surgery|The difference between vWF coagulation protein in blood samples collected at baseline and before surgery were measured using the immune-turbidimetric assay.|Baseline to immediately before surgery (after approximately 4-10 weeks)|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||percentage of vWF protein in blood||Standard Deviation|Mean
1437591|NCT00952731|Secondary|Difference in Mean Score for Vasomotor Symptoms Including Hot Flashes From Baseline to Time of Surgery|Hot flashes were assessed by the Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire. This questionnaire measures the incidence of a number of symptoms by asking participants how frequently they experienced them on a scale of 0-4 (0 being Not at All and 4 being Extremely often). BESS questionnaire was administered at baseline and time of surgery. The incidence of vasomotor symptoms (including hot flashes, night sweats, and cold sweats) was measured at baseline (Day 0) and end of treatment prior to surgery (at least 4 weeks later or up to 10 weeks, depending on scheduled surgery date), and changes in the mean score for hot flashes were observed.|Baseline and after 4-10 weeks of treatment|1 patient who did not complete the treatment period due expired drug supply was not evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
1437592|NCT00952731|Other Pre-specified|TAM Metabolite Concentrations and Estrogen Response Markers in Nipple Aspiration Fluid (NAF)|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
1437593|NCT00952731|Other Pre-specified|4-OHT Affects Known Tamoxifen-modulated Pathways|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
1437594|NCT00952731|Other Pre-specified|Drug Metabolite Levels in the Two Study Groups by CYP2D6 Polymorphism Status|Descriptive statistics and confidence intervals will be provided.|28-70 days|||||||
1437595|NCT00952731|Other Pre-specified|Compare Concentrations of Tamoxifen and Its Metabolites (4-hydroxytamoxifen, Endoxifen, N-desmethyl Tamoxifen (NDT)) Obtained From Samples on the Day of Surgery|Concentrations of tamoxifen and its metabolites: 4-hydroxytamoxifen, endoxifen, and NDT were measured in breast tissue, blood, and Nipple Aspirate Fluid (NAF) that was collected on the day of surgery.|Day of surgery (after approximately 4-10 weeks)|||||||
1437596|NCT00952731|Primary|Difference Between Ki-67 Labeling Index in Tissue Samples Taken at Baseline and Post-treatment|Ki-67 was measured in matched core and excision tissue samples containing DCIS (Ductal Carcinoma In-Situ) lesions, the core sample was at baseline while the excision sample was at surgery (after approximately 4-10 weeks of treatment).|Baseline and after 4-10 weeks of treatment|18 total subjects were evaluable for immunohistochemistry marker testing including the Ki-67 labeling index. Of the 26 participants who completed study treatment 2 did not have matching samples available for testing and 6 were excluded because of insufficient DCIS lesion in their samples for testing.|||percentage of 300 DCIS cells||Standard Deviation|Mean
1437597|NCT00952705|Secondary|The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
1437598|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose||Days 0-180 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
1437599|NCT00952705|Secondary|The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
1437600|NCT00952705|Secondary|The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose||Days 0-28 post dose|The Safety Population included participants who received any investigational product and for whom any follow-up safety data were reported.|||Percentage of Participants|||Number
1437601|NCT00952705|Secondary|The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose||Days 0-14 post dose|The Evaluable Safety Population for solicited symptoms included all participants who received any investigational product and had any solicited symptom data available during the reporting period.|||Percentage of Participants|||Number
1437602|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437603|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437604|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
1437605|NCT00952705|Secondary|The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had post-dose HAI measurement, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
1437606|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437607|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.|Subjects with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437608|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437609|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.|Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had post-dose HAI measurement, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
1437610|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437611|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|The comparator for the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1176 and 294, respectively, received a full dose of investigational product, had post-dose HAI measurement for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of subjects|||Number
1437612|NCT00952705|Secondary|The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|The comparators to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586, respectively, received a full dose of investigational product, had post-dose HAI measurement for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437613|NCT00952705|Secondary|The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 815 and 188, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437718|NCT00951912|Secondary|Urinary Genistein|Urinary genistein excretion|3 months|The number of participants for analysis was determinted by the number of participants who supplied the urine samples at the 3-month test|||ug/ml||Standard Deviation|Geometric Mean
1437614|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 986 and 243, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437615|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 430 and 200, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
1437616|NCT00952705|Secondary|The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 393 and 174, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were seropositive to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
1437617|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 361 and 104, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Victoria, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437618|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 189 and 51, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to B/Yamagata, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437619|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H3N2 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 746 and 386, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H3N2, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437620|NCT00952705|Secondary|The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer ≤ 8 were considered to be serosusceptible for that strain. The comparator for seroresponse to the A/H1N1 strain was participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 783 and 412, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements, were serosusceptible to A/H1N1, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of participants|||Number
1437621|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Victoria strain was participants in the FluMist/B/Victoria arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 298 FluMist/B/Victoria-treated participants, 1176 and 292 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Victoria strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437622|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparator for seroresponse to the B/Yamagata strain was participants in the FluMist/B/Yamagata arm.|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 300 FluMist/B/Yamagata-treated participants, 1175 and 294 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for B/Yamagata strain, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437623|NCT00952705|Secondary|The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. The comparators for seroresponse to the A/H1N1 and A/H3N2 strains were participants in the All FluMist group (combined data for both FluMist arms).|Day 0 and Day 28-35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had pre- and post-dose HAI measurements for the 2 A strains, and had no protocol deviation that could have interfered with generation or interpretation of an immune response.|||Percentage of Participants|||Number
1437624|NCT00952705|Primary|The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).|Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% confidence intervals (CIs) for the ratios of strain-specific HAI GMTs for the specified comparisons. The GMT ratio = GMT in comparator (All FluMist group) divided by the GMT in the Q/LAIV-BFS arm.|Day 28 to 35|Of 1199 Q/LAIV-treated and 598 treated participants in the All FluMist group, 1176 and 586 participants, respectively, received a full dose of investigational product, had a post-dose HAI measurement, and had no protocol violation that could have interfered with generation or interpretation of an immune response.|||Geometric Mean Titer||Full Range|Geometric Mean
1437625|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||hr||Standard Deviation|Mean
1437626|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.|||hr||Full Range|Median
1437627|NCT00952653|Secondary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1437628|NCT00952653|Secondary|Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||hr||Standard Deviation|Mean
1437629|NCT00952653|Secondary|Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the median.|||hr||Full Range|Median
1437630|NCT00952653|Secondary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1437631|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR||Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1437632|NCT00952653|Primary|1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|1-Hydroxy-Midazolam is an analyte of Midazolam.|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1437633|NCT00952653|Primary|Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR|Cmax measured as nanograms per milliliters (ng/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population; N=number of participants contributing to the mean.|||ng/mL||Standard Deviation|Geometric Mean
1437634|NCT00952653|Primary|Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR|AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).|Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing|PK parameter analysis population: all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.|||ng*hr/mL||Standard Deviation|Geometric Mean
1437635|NCT00952614|Secondary|Improvement in Macular Edema on Optical Coherence Tomography and Color Photos|Anatomic Change in reading of the size of the area of retinal thickening on color photographs and OCT. Total Macular Volume (TMV) in mm^3, is the calculated volume from the layers of the retina based off OCT imaging.|baseline (preoperatively) to 3 years postoperatively||||improvement in TMV/mm^3||Inter-Quartile Range|Mean
1437636|NCT00952614|Primary|Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts|Outcome measure based on eyes at time points with 10-letter ETDRS score improvement|baseline (preoperatively) to 3 years postoperatively||||letters read correctly||Full Range|Mean
1437651|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Pyridoxal-5’-Phosphate (PLP)|Change from Baseline to Week 24 in Plasma PLP|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||ng/mL||Standard Deviation|Mean
1437637|NCT00952588|Secondary|Percent of Patients With Worsened Functional Assessment of Cancer Therapy – Leukaemia (FACT-Leu) Score.|The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of “Worsened” was a change from baseline in score of less than or equal to -11.|FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||percentage of participants|||Number
1437638|NCT00952588|Secondary|Percent of Patients With Worsened Trial Outcome Index (TOI)|TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of “Worsened” was a change from baseline in score of less than or equal to -9.|TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||percentage of participants|||Number
1437639|NCT00952588|Secondary|Overall Survival (OS)|Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive.|Assessed from randomisation until the date of death from any cause, assessed up to 24 months|modified Intent to Treat (mITT)|||months||Full Range|Median
1437640|NCT00952588|Secondary|Time To Complete Response (TTCR)|TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)|Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||days||Inter-Quartile Range|Median
1437641|NCT00952588|Secondary|Disease Free Survival (DFS)|Disease-free Survival is defined as the time from randomisation to relapse or death from any cause.|DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||months||Inter-Quartile Range|Median
1437642|NCT00952588|Secondary|Duration of Response (DoR): Stage I and Transition Phase|DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I.|DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (mITT)|||days||Inter-Quartile Range|Median
1437643|NCT00952588|Primary|Percentage of Patients With Overall Complete Response for Stage I|Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to <5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to ≥1.0 x 109/L and platelets to ≥100 x 109/L; transfusion-independence.|IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)|modified Intent to Treat (ITT)|||percentage of participants|||Number
1437644|NCT00952523|Primary|Facial Irritation and Cutaneous Effects|Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.|three weeks||||Scores on a Scale||Standard Deviation|Mean
1437645|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose).|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||h*U/L||Standard Deviation|Mean
1437646|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax).|Time at maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||hours||Standard Deviation|Mean
1437647|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following multiple doses of asfotase alfa.|Study Week 6 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||U/L||Standard Deviation|Mean
1437648|NCT00952484|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||h*U/L||Standard Deviation|Mean
1437649|NCT00952484|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||hours||Standard Deviation|Mean
1437650|NCT00952484|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax).|Maximum serum concentration observed following single dose of asfotase alfa.|Study Week 1 (0 to 48 hours post-dose)|ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).|||U/L||Standard Deviation|Mean
1437719|NCT00951912|Secondary|Urinary Daidzein|Urinary daidzein excretion|3 months|The number of participants for analysis was determinted by the number of participants who provided urine samples at the 3-month test|||ug/ml||Standard Deviation|Geometric Mean
1437652|NCT00952484|Secondary|Change in Biomarkers of Asfotase Alfa Activity as Measured by Plasma Inorganic Pyrophosphate (PPi)|Change from Baseline to Week 24 in Plasma PPi|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||uM||Standard Deviation|Mean
1437653|NCT00952484|Secondary|Change in Height (Z-scores)|Change from Baseline to Week 24 in Height Z-Score. Height Z-Scores assigned based on Centers for Disease Control (CDC) growth charts and methodology.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||Height Z score||Standard Deviation|Mean
1437654|NCT00952484|Secondary|Change in Osteomalacia - Mineralization Lag Time (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in mineralization lag time.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||days||Standard Deviation|Mean
1437655|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Volume/Bone Volume (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid volume/bone volume (%), calculated as the absolute difference of the Baseline and Week 24 percentages.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||percentage points||Standard Deviation|Mean
1437656|NCT00952484|Secondary|Change in Osteomalacia - Osteoid Thickness (as Measured by Trans-iliac Crest Bone Biopsy)|Change from Baseline to Week 24 in osteoid thickness.|Baseline and Week 24|ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.|||um||Standard Deviation|Mean
1437657|NCT00952484|Primary|Change in Rickets Severity on Skeletal Radiographs From Baseline to Week 24 as Measured by the Radiographic Global Impression of Change (RGI-C) Scale|A 7-point RGI-C (radiographic global impression of change) score was used to rate change in rickets severity. Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings.|Baseline and Week 24|ITT population, which included randomized patients that received treatment with asfotase alfa, even if discontinued or lost to follow-up. The last assessment prior to Week 24 is used for missing Week 24 data; patients with no post-baseline assessments imputed as having no change. A historical control group is used for comparison.|||units on a scale||Full Range|Median
1437658|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1437659|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months|Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1437660|NCT00952419|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months|Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.|Days 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1437661|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1437662|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population|||Participants|||Number
1437663|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population|||Participants|||Number
1437664|NCT00952419|Primary|Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1437665|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and Day 21 post-vaccination|Antibody titers were assessed in the per-protocol population.|||Participants|||Number
1437666|NCT00952419|Primary|Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months|Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.|Pre-vaccination (Day 0) and 21 days post-vaccination|Pre- and post-vaccination antibody titers were assessed in the per-protocol population|||Participants|||Number
1437667|NCT00952393|Primary|Blood Levels of Drug|This is the plasma level of the drug as determined by high performance liquid chromatography.|12 hours|This is all participants in the study.|||ng/ml||Standard Deviation|Mean
1437668|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).|Day 1|PP|||relative risk||Standard Error|Mean
1437669|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B|Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).|Day 1|PP|||relative risk||Standard Error|Mean
1437670|NCT00952367|Secondary|Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae|Risk factors include age of mother bearing (less than or equal to [<=] 30 years versus [vs] more than [>] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi [RMB], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to [>=] 10000 RMB); whether have brothers or sisters (yes vs no).|Day 1|PP|||relative risk||Standard Error|Mean
1437671|NCT00952367|Secondary|Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis.|||percentage of isolates|||Number
1437672|NCT00952367|Secondary|Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics|Categories are types of antibiotics.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B.|||percentage of isolates|||Number
1437673|NCT00952367|Secondary|Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics|Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae.|||percentage of isolates|||Number
1437674|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.|||percentage of participants|||Number
1437675|NCT00952367|Secondary|Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.|Day 1|PP. n=number of participants analyzed at that site.|||percentage of participants|||Number
1437676|NCT00952367|Primary|Percentage of Participants With Serotypes of Streptococcus Pneumoniae|Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.|Day 1|PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates.|||percentage of participants|||Number
1437677|NCT00952367|Primary|Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae|A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.|Day 1|Per-protocol (PP): Participants who completed collection of nasopharyngeal swab sample, Epidemiology Questionnaire, and 24 hours safety observation. n=number of participants analyzed at that site.|||percentage of participants|||Number
1437678|NCT00952341|Secondary|Time to First Vomiting Episode in Cycle 1|Time from administration of chemotherapy to first vomiting episode.|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Hours||Standard Error|Mean
1437679|NCT00952341|Secondary|Proportion of Participants With No Impact on Daily Life in Cycle 1|"The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
1437680|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
1437681|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1|Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
1437682|NCT00952341|Secondary|Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
1437683|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1|"Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|25 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
1437684|NCT00952341|Secondary|Proportion of Participants With Complete Response in the Acute Phase of Cycle 1|"Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 24 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
1437685|NCT00952341|Primary|Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.|||Proportion of participants|||Number
1437686|NCT00952289|Secondary|Overall Survival Time at Week 144|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population|||probability||95% Confidence Interval|Number
1437687|NCT00952289|Secondary|Overall Survival at Week 144|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method.|Week 144|ITT population|||participants|||Number
1437688|NCT00952289|Secondary|Overall Survival Time - Extended Data|Overall survival was assessed by the time to death or censoring up until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population|||weeks||95% Confidence Interval|Median
1437689|NCT00952289|Secondary|Overall Survival - Extended Data|Overall survival is reported here by the number of deaths from randomization until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.|From randomization to 4 months after the data cut-off date (up to 18 months).|ITT population|||participants|||Number
1437690|NCT00952289|Secondary|Overall Survival Time|Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population|||weeks||95% Confidence Interval|Median
1437691|NCT00952289|Secondary|Overall Survival|Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method.|From randomization to the data cut-off date (up to 14 months).|ITT population|||participants|||Number
1437702|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.|||Titers||95% Confidence Interval|Geometric Mean
1437720|NCT00951912|Secondary|Total Urinary Isoflavones||3 months|The number of participants for analysis was determinted by the participants who provided the urine samples at the 3-month test.|||ug/ml||Standard Deviation|Geometric Mean
1452608|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 02 from Baseline (i.e., between -45 days and +4 weeks)||||mg/dL||Standard Deviation|Mean
1437692|NCT00952289|Secondary|Change From Baseline to Week 24 in Total Symptom Score|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|This analysis only includes patients who had a non-missing change from Baseline to Week 24. Data collected after the date of treatment cross over were not included in this analysis.|||scores on a scale||Standard Deviation|Mean
1437693|NCT00952289|Secondary|Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.|Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit.|ITT evaluable population included patients with Baseline data and who did not have a 0 total score at both Baseline & Week 24; data measured after the cross over date were excluded. Patients who withdrew, met cross over criteria prior to Week 24 or had a 0 Baseline score & a nonzero/missing score at Week 24 were considered not meeting the endpoint.|||participants|||Number
1437694|NCT00952289|Secondary|Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The duration of ≥ 35% reduction from Baseline in spleen volume was defined as the longest duration of consecutive measurements of ≥ 35% reduction observed before the data cut-off date for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or, who subsequently dropped out prior to another assessment. The duration of a ≥ 35% reduction from Baseline in spleen volume was analyzed using the Kaplan-Meier method.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.|||weeks||95% Confidence Interval|Median
1437695|NCT00952289|Secondary|Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib|The maintenance of ≥ 35% reduction from Baseline in spleen volume was assessed up until the data cutoff date using the Kaplan-Meier method for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or who subsequently dropped out prior to another assessment.|Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months).|Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment.|||proportion of participants||95% Confidence Interval|Number
1437696|NCT00952289|Primary|Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24|Spleen volume was assessed by magnetic resonance imaging (MRI) or by computed tomography (CT) scans if MRI was not suitable, and analyzed by a blinded central laboratory reader. Patients who withdrew, crossed over to ruxolitinib prior to the visit, or had a missing value at the visit were considered non-responders.|Baseline and Week 24|Intent-to-treat (ITT) population included all subjects randomized in the study. Treatment groups for this population were defined according to the treatment assignment at randomization. One patient was not included in the analysis due to a missing baseline spleen volume value.|||participants|||Number
1437697|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older.|||Participants|||Number
1437698|NCT00952276|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years.|||Participants|||Number
1437699|NCT00952276|Primary|Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.|||Titers||95% Confidence Interval|Geometric Mean
1437700|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.|||Participants|||Number
1437701|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.|||Participants|||Number
1437703|NCT00952276|Primary|Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.|||Participants|||Number
1437704|NCT00952276|Primary|Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years|Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.|Day 0 and Day 21 post-vaccination|Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.|||Participants|||Number
1437705|NCT00952211|Secondary|Hospital Anxiety and Depression (HADS) Scale -Depression Subscale|HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms|10 days after beginning CPAP treatment||||units on a scale||Standard Deviation|Mean
1437706|NCT00952211|Primary|Profile of Mood States (POMS) - Fatigue Subscale|POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue|10 days after beginning CPAP treatment|Data only available for 2 subjects; one subject did not provide data for this questionnaire.|||units on a scale||Standard Deviation|Mean
1437707|NCT00952133|Secondary|Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery|Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery.|Pre-op through 96 hours post-op||||participants|||Number
1437708|NCT00952133|Primary|Complete Response Rate|A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia.|Pre-op through 72 hours post emergence from anesthesia||||participants|||Number
1437709|NCT00952120|Secondary|Percentage of Wounds With Total Skin Graft Loss|For each wound, whether there was total skin graft loss by Day 4 or 5 was determined.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables)|||percentage of wounds|Participants||Number
1437710|NCT00952120|Primary|Percentage of Wounds With Complete Skin Graft Take|For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.|Day 4 or 5|Some patients had multiple wounds that required skin grafting. Wounds were the unit of analysis, so a participant with multiple wounds could be in both treatment groups which is why the total number of participants adds to more than the number of unique participants enrolled in the study (and included in the participant flow and baseline tables).|||percentage of wounds|Participants||Number
1437711|NCT00952081|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control)||intraoperatively and 90 min after surgery||||participants|||Number
1437712|NCT00952068|Secondary|Number of Participants With Adverse Events|All adverse events reported during treatment with study drug were considered and reported as treatment emergent adverse events (TEAE) whether or not medication for this adverse event was required by the participant and were summarized in the same table.|6 hours|Safety population: includes all patients who received the dose of the study medication.|||participants|||Number
1437713|NCT00952068|Secondary|Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose|PK samples were drawn at the end of the Screening Phase, at the onset of perceptible pain relief, at 3 hours and at 6 hours post-dose or if the patient discontinues early. PK samples were always drawn after the completion of the patient ratings of pain relief and of pain intensity scales. They were processed in a central laboratory and the plasma levels of tramadol were collected.|Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||ng/ml||Standard Deviation|Mean
1437714|NCT00952068|Secondary|Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain relief rating at time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier.  How would you rate the pain relief the study medication has given you? ranging from 0=none to 4=complete relief. Missing data were imputed using Last Observation Carried Forward (LOCF)."|3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||participants|||Number
1437715|NCT00952068|Secondary|Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose|"Pain intensity rating at baseline, time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. What is your current level of pain intensity? 0=none, 1=mild, 2=moderate, 3=severe. Missing data were imputed using Last Observation Carried Forward (LOCF)."|Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||participants|||Number
1437716|NCT00952068|Primary|Time to Onset of Perceptible Pain Relief|Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.|6 hours|Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.|||minutes||95% Confidence Interval|Median
1437721|NCT00951912|Primary|Percentage Change in Low Density Lipoprotein Cholesterol|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
1437725|NCT00951912|Primary|Percentage Change in QUICKI|"QUICKI is the abbreviation of Quantitative Insulin Sensitivity Check Index,and it is a marker to evaluate insulin sensitivity in HOMA model.It is calculated by using the following equation: 1/(logFIns +logFG),where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter.~The percentage change was caculated as (6th month value-baseline value)/baseline value*100%"|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
1437726|NCT00951912|Primary|Percentage Change in HOMA-IR|HOMA-IR was calculated with the homeostasis model assessment for insulin resistance,and it is caculated as the following equation: HOMA-IR=FIns×FG/22.5, where FIns represents fasting insulin in microunits per milliliter, and FG is in millimoles per liter. The percentage change was caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants for analysis was determinted by intention to treat|||Percentage of change||Standard Deviation|Mean
1437727|NCT00951912|Primary|Percentage Change in Fasting Plasma Insulin|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants was determinted by intention to treat|||percentage of change||Standard Deviation|Mean
1437728|NCT00951912|Primary|Percentage Change in AUC of Glucose|values were from 75g glucose oral glucose tolerance test and caculated as (6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of patticipants was determinted by intention to treat|||percentage of change||Standard Deviation|Mean
1437729|NCT00951912|Primary|Percentage Change in HbA1C|(6th month value-baseline value)/baseline value*100%|Baseline, 6 months|The number of participants analyzed was determinted by intention to treat.|||percentage of change||Standard Deviation|Mean
1437730|NCT00951912|Primary|Percentage Change in 120-minutes Postload Plasma Glucose|(6th month value-baseline value)/baseline*100%|Baseline, 6 months|All participants were determinted by intention to treat|||percentage of change||Standard Deviation|Mean
1437731|NCT00951912|Primary|Percentage Change in Fasting Plasma Glucose|(6th month value-baseline value)/baseline value*100%|Baseline,6 months|the number of participants for analysis was determined by intention to treat|||percentage of change||Standard Deviation|Mean
1437732|NCT00951899|Secondary|Lipid Values|Lipids are fat-like substances in the blood.|Baseline, 12 weeks||||mmol/l||Standard Error|Mean
1437733|NCT00951899|Secondary|Rate of Meal Glucose Disappearance (Meal Rd)|Meal Rd is the rate at which glucose leaves the systemic circulation. It was measured using a triple-tracer mixed meal and reported in micromols over 6 hours. Meal Rd was calculated by subtracting the change in glucose mass from the overall rate of glucose appearance (i.e., meal Ra + EGP).|Baseline, 12 Weeks||||micromol/6h||Standard Error|Mean
1437734|NCT00951899|Secondary|Rate of Meal Glucose Appearance (Meal Ra)|Meal Ra was measured using a triple-tracer mixed meal and reported in micromols in 6 hours. Meal derived glucose is a function of both gastric emptying and splanchnic meal extraction. Meal Ra was calculated by multiplying rate of appearance of [1-^13C] glucose (obtained from the infusion rate of [6-^3H] glucose and the clamped plasma ratio of [6-^3H] glucose and [1-^13C] glucose) by the meal enrichment.|Baseline, 12 Weeks||||micromol/6h||Standard Error|Mean
1437735|NCT00951899|Secondary|Fasting Endogenous Glucose Production (EGP)|EGP was measured using a triple-tracer mixed meal and calculated using the Steele's model, reported in micromoles per kilogram per minute.|Baseline, 12 Weeks||||micromol/kg/min||Standard Error|Mean
1437736|NCT00951899|Secondary|Insulin Concentration|Fasting insulin levels were measured in the plasma using a chemiluminescence assay and is reported in nanomoles over 6 hours.|Baseline, 12 Weeks||||nmols/6 hrs||Standard Error|Mean
1437737|NCT00951899|Secondary|Glycosylated Hemoglobin (HbA1c)|HbA1c is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months.|Baseline, 12 weeks||||Percentage of hemoglobin||Standard Error|Mean
1437738|NCT00951899|Secondary|Plasma Glucose Concentration|Fasting glucose concentrations were measured at baseline and 2 hours post-meal using the glucose oxidase method.|Baseline, 12 Weeks||||mmol/L||Standard Error|Mean
1437739|NCT00951899|Secondary|Total Fasting Glucagon-Like Peptide-1 (GLP-1) Concentration|GLP-1 is thought to increase insulin secretion and was measured in the blood and reported in picomoles per liter.|Baseline, 12 weeks||||pmol/L||Standard Error|Mean
1437740|NCT00951899|Primary|Total Disposition Index|Total Disposition Index (DI) is a calculated value which represents the ability of a person's pancreas to lower blood glucose. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose.|Baseline, 12 weeks|Intent to treat analysis population.|||DItot (10^-14 dl/kg/min^2 per pmol/l)||Standard Error|Mean
1437741|NCT00951821|Secondary|Beck Suicide Scale - Adolescent Response|measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation. These data refer to adolescent respondents. The outcome is a change score so range is from -38 to 38.|Measured at 12 months|intent to treat|||units on a scale||Standard Error|Mean
1437742|NCT00951821|Primary|Beck Depression Inventory - Adolescent Report, Change in Symptom Level|self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression. The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.|12 months|intent to treat|||change in BDI (-60 to 60 possible range)||Standard Error|Mean
1437743|NCT00951808|Primary|Acute Chest Syndrome|First occurence of positive infiltrate on chest x-ray|Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.|Of 237 enrolled subjects, 27 subjects who received a transfusion and 7 subjects who had insufficient sPLA2 measurements were excluded. Therefore, two hundred and three (203) subjects were included in the analysis. Results were not reported by Arm due to the lack of enrollment.|||participants|||Number
1437744|NCT00951665|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the first day of study treatment to documented disease progression or death on study i.e., death due to any cause within 30-days of last dose of study treatment, whichever occurs first.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.|||months||Full Range|Median
1437745|NCT00951665|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit is defined as CR, PR, or stable disease (SD) of 6 months or more duration as assessed by the investigator. CR and PR are identified in previous outcome measure. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included.|||percentage of participants|||Number
1437746|NCT00951665|Secondary|Duration of Objective Response|Duration of OR is only calculated for participants with OR and is defined as the time from the first tumor assessment that supports the participant`s OR to disease progression or death.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with OR were considered for this outcome measure.|||months||95% Confidence Interval|Median
1437747|NCT00951665|Secondary|Percentage of Participants With Objective Response Rate (ORR)|Participants with measurable disease (at least one lesion 2 centimeters [cm] or more on computed tomography (CT) scan or 1 cm or more on spiral CT scan) were considered for OR. ORR is defined as the percentage of patients with a complete response (CR)/partial response (PR) determined on two consecutive tumor assessments at least 4 weeks apart based on modified Response Evaluation Criteria in Solid Tumors, Version 1.0 (RECIST). CR defined as disappearance of all target and non-target lesions and normalization of tumor marker level. PR defined as at least 30 percent decrease in sum of the longest diameters of the target lesions taking as reference the baseline sum longest diameters.|Tumor assessments performed at the end of Cycle 2 and then every 2 cycles (i.e., Cycles 4, 6, 8, 10, etc. [each cycle of 21 days]) throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|An efficacy population: All participants who received at least a single dose of study medication were included. Participants with measurable disease were considered for OR.|||percentage of participants|||Number
1437748|NCT00951665|Primary|Number of Participants With Change From Baseline in Cardiac Function|Change in cardiac functions i.e., left ventricular ejection fraction (LVEF) and segmental wall abnormalities were assessed by echocardiogram or multigated acquisition scans. LVEF was assessed as change from baseline as 0 to <15%, >=15 to <25%, >=25%, and missing values.|Baseline (30 days prior to study dose), end of Cycle 2, and then every three cycles in Phase Ib and every four cycles in Phase IIa throughout the duration of the study (12 months) until disease progression or study discontinuation, whichever occurs first|Safety Population: All participants who received at least a single dose of study medication were included.|||participants|||Number
1437749|NCT00951665|Primary|An Apparent Volume of Distribution at Steady-state (Vss) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-inf]) X (AUMC[0-inf])/AUC[0-inf]) where D is the dose of study drug, AUMC(0-inf) is the area under the first moment curve extrapolated to infinity and AUC(0-inf) is the area under the plasma concentration-time curve from time zero to infinite time. The Vss of paclitaxel (65 mg/m2 and 80 mg/m2) is observed in Cycle 1 (in the absence of T-DM1) and Cycle 2 (in the presence of T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||L/m^2||Standard Deviation|Mean
1437750|NCT00951665|Primary|Plasma Clearance (CL) of Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma CL of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis for in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||L/hr/m^2||Standard Deviation|Mean
1437751|NCT00951665|Primary|An Elimination Half-life (t1/2) of Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma t1/2 of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||hr||Standard Deviation|Mean
1437752|NCT00951665|Primary|Area Under Plasma Concentration - Time Curve of Paclitaxel From Time 0 to Infinity (AUC0-inf) in Cycle 1 (in the Absence of T-DM1) and Cycle 2 (in the Presence of T-DM1)|Plasma AUC0-inf of paclitaxel (65 mg/m^2 and 80 mg/m^2) was estimated by non-compartmental analysis in Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1).|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||hr*ng/mL||Standard Deviation|Mean
1437812|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain|The participant’s assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as “no pain” and the right-hand as “unbearable pain”. The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded.|Week 24|ITT population|||percent change in mm||Standard Deviation|Mean
1437753|NCT00951665|Primary|Maximum Plasma Concentration of Paclitaxel in Cycle 1 (in the Absence T-DM1) and Cycle 2 (in the Presence T-DM1)|Plasma Cmax of paclitaxel (65 mg/m^2 and 80 mg/m^2) for Cycle 1 (in the absence T-DM1) and Cycle 2 (in the presence T-DM1) was estimated by non-compartmental analysis.|Pre-dose, and 0.25, 1, 2, 4, 6, and 24 hours post-dose for Cycle 1 and Cycle 2|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. “n” denotes number of participants who received the indicated study drug.|||ng/mL||Standard Deviation|Mean
1437754|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUClast) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|AUClast for serum T-DM1 and serum total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||day*µg/mL||Standard Deviation|Mean
1437755|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After QW Dose Regimen|Cmax for plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered QW|Pre-dose, and 0.25 and 4 hours post-dose on Day 1, and Day 8 (before T-DM1 dose)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||ng/mL||Full Range|Mean
1437756|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After QW Dose Regimen|Cmax for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis when T-DM1 was administered QW.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||mcg/mL||Standard Deviation|Mean
1437757|NCT00951665|Primary|Area Under the Serum Concentration-time Curve of Total Exposure (AUC0-Day 21) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|AUC0-21 for serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre- and post-dose (0.25 and 4 hours and Day 8 [before paclitaxel infusion) for Cycle 1 and pre- and post-dose (0.25 and 4 hours) for Cycle 2 (each cycle of 21 days)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||day*mcg/mL||Standard Deviation|Mean
1437758|NCT00951665|Primary|Maximum Plasma Concentration (Cmax) of DM1 in Cycle 1 After Q3W Dose Regimen|Cmax of plasma DM1 in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|PK population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||nano gram per milliliter (ng/mL)||Full Range|Mean
1437759|NCT00951665|Primary|Maximum Serum Concentration (Cmax) of T-DM1 and Total Trastuzumab in Cycle 1 After Q3W Dose Regimen|Cmax of serum T-DM1 and total trastuzumab (sum of conjugated and unconjugated trastuzumab) in Cycle 1 was estimated by non-compartmental analysis for Phase Ib when T-DM1 was administered Q3W.|Pre-dose, and 0.25 and 4 hours post-dose on Day 1; Day 8 (before paclitaxel infusion)|Pharmacokinetics (PK) population included all participants from Phase Ib who received at least one dose of T-DM1 or paclitaxel with at least one post-dose concentration data point. Only participants with data available for this parameter were analyzed.|||microgram per millilitre (Mcg /mL)||Standard Deviation|Mean
1437760|NCT00951665|Primary|Number of Participants Who Had Adverse Events That Required Dose Modification of T-DM1 or Paclitaxel|Participants were assessed for toxicity prior to each dose of T-DM1 and paclitaxel; dosing occurred only if the clinical assessment and laboratory test values were acceptable. Dose modifications included dose delayed or any dose reduction. Participants in whom significant toxicities had not recovered to the treatment range defined by the dose modification guidelines at the time of their next scheduled dose, had their dose of T-DM1 and/or paclitaxel delayed or reduced for up to 21 days.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.|||participants|||Number
1437761|NCT00951665|Primary|Number of Participants in Phase IIa of the Study Who Received 12 or More Paclitaxel Doses in Combination With T-DM1 and/or Pertuzumab|Participants in Phase IIa received T-DM1 Q3W and paclitaxel in Group A and T-DM1, paclitaxel, and pertuzumab in Group B.|From Day 1 to 15 weeks|Safety Population: All participants of the phase IIa part of the study who received at least a single dose of study medication and did not have disease progression in the first 12 weeks of study treatment were included.|||participants|||Number
1437762|NCT00951665|Primary|Maximum Tolerated Dose of Paclitaxel When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when paclitaxel (QW) and T-DM1 (Q3W or QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.|||mg/m^2|||Number
1437763|NCT00951665|Primary|Maximum Tolerated Dose of T-DM1 When T-DM1 (Q3W or QW) and Paclitaxel (QW) Was Administered With and Without Pertuzumab|The MTD was defined as the highest dose of T-DM1 and paclitaxel at which 0 of 3 participants or 1 of 6 experienced a DLT, when T-DM1 (Q3W or QW) and paclitaxel (QW) was administered with and without pertuzumab treatment.|Days 1 to 21|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included.|||mg/kg|||Number
1437828|NCT00951093|Primary|Total Esophageal Acid Exposure at 24h pH Monitoring|Esophageal acid exposure was measured through 24h pH monitoring. During the entire period, esophageal pH was measured and recorded as the percent of time pH was below 4.|Before GBP, 6 months after GBP and 39 months after GBP||||percentage of time||Inter-Quartile Range|Median
1437764|NCT00951665|Primary|Number of Participants With Dose Limiting Toxicity (DLT) of the Combination of T-DM1 and Paclitaxel When T-DM1 Was Administered on Either an Q3W or QW Schedule for Both With and Without Pertuzumab Treatment|DLT is defined as one of the following toxicities related to study drug during Cycle 1, according to the NCI CTCAE, Version 3: Grade 3 or higher non-hematologic AEs; Grade 3 or higher elevation of serum bilirubin, hepatic transaminases, or alkaline phosphatase; Grade 4 or higher thrombocytopenia; Grade 4 or higher neutropenia; any subjectively intolerable toxicity related to T-DM1, paclitaxel, or pertuzumab; any treatment-related toxicity prohibiting the start of the second cycle of treatment and/or prompting to a dose delay or modification during the DLT observation period, such as prompting a dose reduction at Cycle 2 Day1.|Up to 23 days|Safety Population: All participants of the dose finding part of the study (phase 1b) who received at least a single dose of study medication were included. Participants in Phase 1b (Regimen 1, Regimen 2, Regimen 3 and Regimen 4 [60 participants]) were considered for this analysis.|||participants|||Number
1437765|NCT00951665|Primary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Grades 3/4, and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 30 days after the last dose of study treatment or study discontinuation/termination, whichever is later|Safety Population: All participants who received at least a single dose of study medication were included.|||participants|||Number
1437766|NCT00951561|Primary|Percentage of Intervention Uses That Resulted in at Least 1 Point Decrease in Pain and Requiring no Rescue Medication Using the Modified Melzack-McGill Scale Using a Mixed Model|Modified Melzack-McGill Scale measures general pain (0=none, 1-3=mild, 4-6=moderate, 7-9=severe, 10=worst pain) Total Number of Uses Analyzed is a sum of the Number of Uses collected at each time point.|1 month, 2 months, 3 months, 4 months|Statistical analysis was carried out per plan.|||percentage of uses|Participants||Number
1437767|NCT00951509|Primary|Composite Power Mobility Road Test (PMRT) Scores|The computer-based and the virtual environments will be modeled after and scored similarly to the real world PMRT. The PMRT contains two domains: Structured Elements/Tasks and Unstructured Skilled Driving. The first domains contain 16 tasks that include activities such as passing through standard width doorways, and turning a ninety-degree turn, turning 180 degrees. In both domains, each task is scored from 1 to 4, depending on speed and the number of collisions that occur with obstacles. A total score for the entire test is calculated out of a possible 64 points, and the final score on the test reflects the percentage of total points acquired1. A passing score is a percentage of > 95%.|Baseline in-lab testing|Majority of the participants (41%) had a spectrum of multiple disabilities ranging from stroke, spinal stenosis, osteoarthritis, emphysema, and cerebral degeneration, followed by 11 participants (35%) with spinal cord injury.|||units on a scale||Standard Error|Mean
1437768|NCT00951496|Secondary|Patient Reported Nausea|Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much)|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment|Patients evaluable for PRO (Patient Reported Outcomes)/QOL are patients who completed baseline and at least one follow-up assessment|||units on a scale||Standard Error|Least Squares Mean
1437769|NCT00951496|Secondary|Patient Reported Fatigue|Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue.|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment|Patients evaluable for PRO (Patient Reported Outcomes)/QOL. Evaluable patients have completed baseline and at least one follow-up assessment.|||units on a scale||Standard Error|Least Squares Mean
1437770|NCT00951496|Secondary|Patient Reported Neurotoxicity (Ntx)|The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL.|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment|Patients evaluable for PRO(Patient Reported Outcome)/QOL (completed baseline and at least one follow-up assessment).|||Units on a scale||Standard Error|Least Squares Mean
1437771|NCT00951496|Secondary|Patient Reported Quality of Life (QOL)|QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL).|Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment|Patients evaluable for PRO (Patient Reported Outcomes)/QOL (completed baseline and at least one follow-up assessment)|||Units on a scale||Standard Error|Least Squares Mean
1437773|NCT00951496|Secondary|Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0|Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event.|During treatment and up to 30 days after end of treatment|Treated Patients|||Participants|||Count of Participants
1437774|NCT00951496|Primary|Median Progression-free Survival|Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.|Intention-to-treat: All enrolled patients|||months||95% Confidence Interval|Median
1437775|NCT00951483|Secondary|Change in 14-item Perceived Stress Scale (PSS-14)|The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress.|Baseline and 12 weeks|This analysis is restricted to the twenty-three individuals from the intervention cohort had valid PSS-14 responses at baseline and 12 weeks; the healthy control arm is not included, because their PSS-14 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
1437776|NCT00951483|Secondary|Change in Beck Depression Inventory (BDI)|The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-seven individuals from the intervention cohort had valid BDI responses at baseline and 12 weeks; the healthy control arm is not included, because their BDI scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
1437777|NCT00951483|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A)|The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-A responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-A scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
1437778|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)|The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-D-21 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-21 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
1437779|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)|The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-17 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-17 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
1437780|NCT00951483|Secondary|Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)|The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood.|Baseline and 12 weeks|This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-7 responses at baseline and 12 weeks; the healthy control arm is not included here, because their HAM-D-7 scores were recorded at baseline only (see baseline characteristics).|||units on a scale||Inter-Quartile Range|Median
1437781|NCT00951483|Primary|C-Reactive Protein at 12 Weeks|To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.|12 weeks|Due to the cost for the C-reactive protein assay, only 20 individuals from each cohort are analyzed (N = 40).|||mg/L||Inter-Quartile Range|Median
1437782|NCT00951379|Primary|Dichotomized Clinical Response: Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|Clinical Response assessed according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. Complete Response (CR): Disappearance of all evidence of target AND non-target lesions. Partial Response (PR): greater than or equal to 50% reduction in the sum of the products of diameters of all target lesion(s). Non-target lesions may not increase greater than or equal 25% in size and no new lesion may appear. No Change (NC): No change in the size of the lesion(s) and no new lesions appearing, i.e. anything that is not CR, PR or PD. Progressive Disease (PD): Any increase greater than or equal to 25% in the product of the diameters of any measurable lesions or in the estimated size of non-measurable lesions or the appearance of an unequivocal new lesion.|Response assessed at Week 24 ±1 Week|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
1437829|NCT00951093|Primary|Number of Participants With Gastroesophageal Reflux Disease (GERD)|Prevalence of GERD in patients characterized according to troublesome symptomatic syndromes assessed through a validated questionnaire based on the Montreal Consensus.|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
1437783|NCT00951379|Primary|Dichotomized Histologic Response (HR): Participant Complete or Partial Response Defined as =/>50% Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia|HR according to criteria & recorded as Response or No Response, analyzed as dichotomous variable. CR: Complete reversal dysplasia/hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree dysplasia/hyperplasia in all biopsied lesion from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable. No Change (NC): No change in degree dysplasia/hyperplasia in all biopsied lesions, anything not CR, PR or PD. Progressive Disease (PD): Any increase in severity histology grade any biopsied lesion. Early premalignant lesion: lesion defined high risk, indicated by presence of one: hyperplasia at high-risk sites (dorsal, lateral or ventral tongue, or floor of mouth) ONLY, or mild dysplasia. Advanced premalignant lesion: lesion with presence of one: moderate dysplasia or severe dysplasia (excluding CIS), erythroplakia with hyperplasia or of any severity of dysplasia.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
1437784|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of PPARG Nucleus and PPARG Cytoplasm|Tissue levels of Peroxisome proliferator-activated receptor gamma (PPARG) Nucleus and PPARG Cytoplasm as indirect measures of pharmacological effect, PPAR gamma assessed by immunohistochemistry. Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed at end of study, and two participants in Placebo were not analyzed for PPARG baseline scores. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
1437785|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of B-cell Lymphoma 2 (Bcl2)|Tissue levels of Bcl2 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported a percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants of 25 overall in the Pioglitazone arm were not analyzed for Bcl2 end of study score and one participant in Placebo was not analyzed for Bcl2 baseline score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
1437786|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of p21|Tissue levels of p21 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for p21 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
1437787|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Ki-67|Tissue levels of Ki-67 for proliferation assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Four participants in the Pioglitazone arm were not analyzed for Ki-67 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
1437788|NCT00951379|Secondary|Biomarker Measurements at Scheduled Visits: Tissue Levels of Cyclin D1|Tissue levels of Cyclin D1 as indirect measures of pharmacological effect assessed by immunohistochemistry (IHC). Tissue levels of biomarkers assessed from the biopsy obtained at the Screening Clinic Visit and Week 24 ± 1 Week, and plasma levels of biomarkers assessed from blood collected at the Baseline Clinic Visit and Week 24 ± 1 Week. Data reported as percentage of cells staining positive, according to nuclear or cytoplasmic compartments.|Baseline to end of study, 24 weeks|Two participants in the Pioglitazone arm were not analyzed for Cyclin D1 end of study score. Analysis is based on specimen viability/availability. No exclusions are made for any other reason.|||percentage of staining cells positive||Standard Deviation|Mean
1437789|NCT00951379|Secondary|Number of Participants Affected by Adverse Events Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0)|All adverse events (including serious) and clinical laboratory toxicity summarized affected organ system. Reporting based on the NCI CTCAE v4.0 by treatment, details included in later Adverse Event Module of results.|Up to 26 weeks|Population includes all enrolled participants.|||participants|||Number
1437790|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Alcohol Use|Alcohol use will be summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical and pathological response assessed using statistical regression models in an exploratory fashion. Heavy drinkers are participants who drank every day; Light drinkers are participants who drank on some days; Non-drinkers are former drinkers or those who never drank alcohol.|Up to 26 weeks|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
1437791|NCT00951379|Secondary|Number of Participant With Clinical Response by Baseline Characteristics: Tobacco Use|Tobacco use summarized by treatment stratified by stage and by group. In addition, the effects of tobacco and alcohol use on the primary endpoint of clinical response assessed.|Up to 26 weeks|Analysis includes all participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
1437792|NCT00951379|Secondary|Number of Participants With Level of C-reactive Protein in Plasma Decrease From >5.0 mg/L to <= 5.0 mg/L From Baseline to End of Study|The longitudinal regression models for analysis of the change in CRP in plasma will be used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates.|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 20 evaluable specimens at baseline & 20 at end of study with 2 of those not available for the CRP>5 baseline measure & Placebo's 25 had 25 evaluable at baseline & 21 evaluable at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participants needed 1/+ dose of treatment.|||participants|||Number
1437793|NCT00951379|Secondary|Number of Participants With >5.0 mg/L in Level of C-reactive Protein in Plasma|"Degree of change of C-reactive protein (CRP) in plasma serum via blood tests.~The longitudinal regression models for analysis of the change in CRP in plasma used, with suitable transformation if necessary to satisfy the model assumptions, with treatment, stage and biomarker value at screening visit as covariates."|Baseline to end of study, 24 weeks|Pioglitazone's 26 had 24 evaluable specimens at baseline & 20 evaluable at end of study with 2 of those not available for CRP>5 baseline measure: Placebo's 25 had 25 evaluable specimens at baseline & 21 at end of study. Analysis based on specimen viability/availability, no exclusions made for other reasons, participant needed 1/+ dose of treatment.|||participants|||Number
1437794|NCT00951379|Primary|Overall Response <Clinical and Histologic Response Defined as 50% or Greater Reduction in the Sum of the Measured Products of Perpendicular Dimensions of the Target Lesion(s) or Improvement in the Degree of Dysplasia or Hyperplasia>|Overall Dichotomized Clinical and Histologic Response defined as 50% or greater reduction in sum of the measured products of perpendicular dimensions of the target lesion(s) or improvement in the degree of dysplasia or hyperplasia where complete (CR) or partial response (PR) in either clinical or histologic outcome assessed according to criteria given recorded as Response or No Response and analyzed as a dichotomous variable. Clinical Response = CR: Disappearance all evidence target & non-target lesions; PR: >/=50% reduction in sum products of diameters all target lesion(s). Non-target lesions may not increase >/=25% in size & no new lesion. Histologic Response = CR: Complete reversal of dysplasia or hyperplasia to normal epithelium in all biopsied lesions. PR: Improvement of degree of dysplasia or hyperplasia in all biopsied lesion(s) from advanced to early, or from early to normal epithelium in some lesions while other biopsied lesions remain stable.|Response assessed at Week 24 ±1 Week|All participants who received at least one dose of treatment. One participant in the Pioglitazone arm never received study drug.|||participants|||Number
1437795|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
1437796|NCT00951275|Secondary|Efficiency as Assessed by SF-HLQ|Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
1437797|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score|"Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement."|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
1437798|NCT00951275|Secondary|SF-HLQ Hindrance Score|"Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score)."|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||units on a scale||Standard Deviation|Mean
1437830|NCT00951093|Primary|Number of Participants With Esophageal Injury|Syndromes with esophageal injury were represented exclusively by the presence of reflux esophagitis|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
1437799|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||hours||Standard Deviation|Mean
1437800|NCT00951275|Secondary|Number of Hours as Assessed by SF-HLQ|Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||hours||Standard Deviation|Mean
1437801|NCT00951275|Secondary|Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Weeks 12 and 24|ITT population; n=number of participants assessed for the specified parameter.|||days||Standard Deviation|Mean
1437802|NCT00951275|Secondary|Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Baseline|ITT population; n=number of participants assessed for the specified parameter.|||days||Standard Deviation|Mean
1437803|NCT00951275|Secondary|Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin||Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1437804|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in DAS28 Score|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population|||percent change from baseline||Standard Deviation|Mean
1437805|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by DAS28 Category|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1437806|NCT00951275|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (<)3.2 and improvement from baseline of >1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of >5.1 and improvement from baseline of >1.2; No response was defined as a DAS28 score of >5.1 and improvement from baseline of <1.2. Participants who discontinued prematurely were identified as non-responders.|Week 24|ITT population|||percentage of participants||95% Confidence Interval|Number
1437807|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in ESR|ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr.|Week 24|ITT population|||percent change in mm/hr||Standard Deviation|Mean
1437808|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)|hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L).|Week 24|ITT population|||percent change in mg/L||Standard Deviation|Mean
1437809|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in HAQ-DI|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.|Week 24|ITT population|||percent change from baseline||Standard Deviation|Mean
1437810|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity|The physician’s assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme was considered “maximum disease activity”. The physician’s global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded.|Week 24|ITT population|||percent change in mm||Standard Deviation|Mean
1437811|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity|The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as “no disease activity” (symptom free and no arthritis symptoms) and the right-hand extreme as “maximum disease activity” (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded.|Week 24|ITT population|||percent change in mm||Standard Deviation|Mean
1437813|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in SJC|Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population|||percent change in swollen joints||Standard Deviation|Mean
1437814|NCT00951275|Secondary|Percent Change From Baseline to Week 24 in TJC|Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement.|Week 24|ITT population|||percent change in tender joints||Standard Deviation|Mean
1437815|NCT00951275|Primary|Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.|Week 4|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1437816|NCT00951275|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement|The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]).|Week 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
1437817|NCT00951275|Secondary|Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1437818|NCT00951275|Secondary|FACIT-F Scores|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline.|Baseline, Weeks 2, 4, 8,12, 16, 20 and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1437819|NCT00951275|Secondary|Improvement of Anemia Assessed as Change From Baseline in Hemoglobin|Improvement of anemia was evaluated as change in hemoglobin levels from baseline.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
1437820|NCT00951275|Primary|Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin|Hemoglobin levels were measured as grams/deciliter (g/dL).|Week 4|ITT population|||g/dL||Standard Deviation|Mean
1437821|NCT00951275|Secondary|Mean Hemoglobin Levels During the Study||Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||g/dL||Standard Deviation|Mean
1437822|NCT00951171|Secondary|Positive Pregnancy Test||14 days|||||||
1437823|NCT00951171|Secondary|Live Birth||9 months|||||||
1437824|NCT00951171|Primary|Clinical Pregnancy|positive beta HCG test|1 month|All study women undergoing IUI were included|||positive pregnancy test (beta HCG)|||Number
1437825|NCT00951093|Primary|Number of Participants With Increased Acid Exposure|Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
1437826|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Supine Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in supine position|Before GBP, 6 months after GBP and 39 months after GBP||||percentage of time||Inter-Quartile Range|Median
1437827|NCT00951093|Primary|Esophageal Acid Exposure at 24h pH Monitoring in Upright Position|Esophageal acid exposure was measured through 24h pH monitoring. Esophageal pH was measured and recorded as the percent of time pH was below 4 while participant in upright position|Before GBP, 6 months after GBP and 39 months after GBP||||percentage of time||Inter-Quartile Range|Median
1438449|NCT00946348|Secondary|To Assess the Effects of Dronabinol in This Population to Determine Whether Measures of Craving, Mood and Negative Symptoms Will Improve Using the PANSS; and to Determine Whether Measures of Psychotic Symptoms and Cognitive Deficits Will Increase.||Over 8 hours|||||||
1437831|NCT00951093|Primary|Number of Participants Presenting Reflux Symptoms|"Prevalence of typical reflux syndrome according to the Montreal Consensus. This Consensus institutes that GERD can be outlined when troublesome symptoms and/or complications induced by reflux of the gastric content back to the esophagus are present.~In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language was used."|Before GBP, 6 months after GBP and 39 months after GBP||||participants|||Number
1437832|NCT00951015|Other Pre-specified|Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points|Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population||||||
1437833|NCT00951015|Secondary|Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters|Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).Only those participants available at the specified time points were analyzed represented by n=X in the category titles|Week 96|PK/PD Analysis Population.|||estimated effect|||Number
1437834|NCT00951015|Secondary|Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.|Week 96|PK/PD Analysis Population.Only those participants available at the specified time points were analyzed|||Pearson's correlation coefficient|||Number
1437835|NCT00951015|Secondary|Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters|Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|Week 96|PK/PD Analysis Population.|||Pearson's correlation coefficient|||Number
1437836|NCT00951015|Secondary|Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters|Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures|Week 2|PK/PD Analysis Population.Only those participants available at the specified time points were analyzed.|||Pearson's correlation coefficient|||Number
1437837|NCT00951015|Secondary|Time to Maximal Drug Concentration (Tmax) of DTG|Tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.|||Hours||Full Range|Median
1437838|NCT00951015|Secondary|Pre-dose Concentration (C0) and C0 Avg of DTG|The plasma DTG C0 of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.|Week 2, Week 12, and Week 24|PK Summary Population.|||Microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1438072|NCT00950599|Secondary|Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1437839|NCT00951015|Secondary|Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG|The Cmax, Cmax, and Ctau of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.|Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population. Only those participants available at the specified time points were analyzed.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1437840|NCT00951015|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed.|Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2|PK Summary Population.|||Hours*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1437841|NCT00951015|Secondary|Plasma DTG Concentration|Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.|Week 2, Week 12, and Week 24|PK Summary Population.|||Micrograms per milliliter (µg/mL)||Standard Deviation|Mean
1437842|NCT00951015|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data|From Baseline up to Week 96/Early Withdrawal|On-treatment Phenotypic Resistance Population|||Participants|||Number
1437843|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population|||Participants|||Number
1437844|NCT00951015|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.|From Baseline up to Week 96/Early Withdrawal|On-treatment Genotypic Resistance Population.|||Participants|||Number
1437845|NCT00951015|Secondary|Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities|Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From Baseline up to Week 96/Early Withdrawal|Safety Population|||Participants|||Number
1437846|NCT00951015|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From Baseline up to Week 96/Early Withdrawal|Safety Population:All participants who received at least one dose of the study medication|||Participants|||Number
1437847|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population|||Participants|||Number
1437848|NCT00951015|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population|||Participants|||Number
1437849|NCT00951015|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)|Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.|From Baseline up to Week 96|ITT-E Population|||Participants|||Number
1437850|NCT00951015|Secondary|Number of Participants With New HIV-associated Conditions of the Indicated Class|HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.|From Baseline up to Week 96|ITT-E Population|||Participants|||Number
1437851|NCT00951015|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population.|||Cells per cubic millimeter||Inter-Quartile Range|Median
1437852|NCT00951015|Secondary|Change From Baseline in HIV-1 RNA at the Indicated Time Points|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Log10 c/mL||Standard Deviation|Mean
1437853|NCT00951015|Secondary|Viral Change Over the Initial 2 Weeks of Treatment|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline. Only those participants available at the specified time point were analyzed.|Baseline and Week 2|ITT-E Population.|||Log10 c/mL||Standard Deviation|Mean
1437890|NCT00950833|Secondary|Number of Subjects With New Acquisition of H. Influenzae in Nasopharyngeal Swabs|Frequency of acquisition of new H. influenzae strains in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
1438331|NCT00947544|Primary|Rate of Adverse Events During the Switchover Part of the Study Rate of Adverse Events (Number of Participants Showing Adverse Events)|To evaluate the safety and PK characteristics of HPN-100 compared with sodium phenylbutyrate (NaPBA) in pediatric patients with urea cycle disorders (UCDs)|1 week on each treatment for a total of 2 week.||||participants|||Number
1437854|NCT00951015|Primary|Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16|Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication|Week 16|ITT-E Population|||participants|||Number
1437855|NCT00950963|Secondary|Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study|Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.|18 months||||Participants|||Number
1437856|NCT00950963|Secondary|Number of Patients With BP Less Than 130/80 mm Hg|Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.|18 months|Analysis per intention to treat|||participants|||Number
1437857|NCT00950963|Other Pre-specified|Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.|Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations|18 months|Analysis per intention to treat|||Number of ED visits and hospitalizations|||Number
1437858|NCT00950963|Secondary|Number of CVD Patients With LDL Less Than 70 mg/dL.||18 months|Analysis was per intention to treat|||Participants|||Number
1437859|NCT00950963|Primary|Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL|Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study|18 months|Analysis was per intention to treat.|||Participants|||Number
1437860|NCT00950937|Secondary|Peak Oxygen Uptake|Is the maximum capacity of an individual's body to transport and utilize oxygen during incremental exercise.|1 time, before the exercise protocol||||ml/min||Standard Deviation|Median
1437861|NCT00950937|Secondary|Neutrophil Count|Neutrophil count at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||Cell/ul of blood||Inter-Quartile Range|Median
1437862|NCT00950937|Secondary|T CD4|T CD4 lymphocytes counts at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||Cell/ul of blood||Inter-Quartile Range|Median
1437863|NCT00950937|Secondary|Lipid Peroxidation|Thiobarbituric acid–reactive substances (TBARS) assay was used as an index of lipid peroxidation in erythrocytes, at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||picomol of TBARS/mg protein||Inter-Quartile Range|Median
1437864|NCT00950937|Secondary|Glutathione S-transferase (GST)|Antioxidant activity of the Glutathione S-transferase enzyme at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||micromol of GST/min/mg of protein||Inter-Quartile Range|Median
1437865|NCT00950937|Primary|Total Glutathione|The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||nmoles glutathione/ ml of sample||Inter-Quartile Range|Median
1437866|NCT00950937|Secondary|Catalase Activity|Antioxidant activity of the catalase enzyme at three moments: baseline, aerobic and exercise.|3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).||||units of catalase /mg protein||Inter-Quartile Range|Median
1437867|NCT00950911|Primary|Number of Participants Survived||2 years|Full Analysis Set|||Participants|||Number
1437868|NCT00950872|Secondary|Incidence of Stapler 'Misfires'|The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||participants|||Number
1437869|NCT00950872|Secondary|Length of Hospital Stay|Days spent in the hospital|Day 2 (Approximately 1.5 days post randomization)|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||days||Standard Deviation|Mean
1437870|NCT00950872|Secondary|Operating Room (OR) Time|OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.|Day 0|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||minutes||Standard Deviation|Mean
1437871|NCT00950872|Primary|Incidence of Adverse Events.||Day 30|Of the 29 eligible patients, 2 did not have surgery resulting in a total of 27 patients for the analysis.|||adverse events|||Number
1437872|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Hematological Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 hematological toxicities included: Hemoglobin, Platelet Count, Total Neutrophils, and White Blood Cell count.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG|||Participants|||Number
1438332|NCT00947531|Secondary|Combined Response, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 24|||||||
1437873|NCT00950859|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Clinical Chemistry Toxicities|Hematology and clinical chemistry data were summarized according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, dated December 2004. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Potentially life-threatening. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. The Grade 3 and Grade 4 clinical chemistry toxicities included: Albumin, Alkaline Phosphatase, Amylase, Aspartate Amino Transferase, Carbon dioxide content/Bicarbonate, Creatinine, Creatinine Clearance, Hypercalcemia, Hyperglycaemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycaemia, Hypokalemia, Hyponatremia, LDL Cholesterol, Magnesium, Phosphorus inorganic, and Total Bilirubin, Alanine Amino Transferase, Calcium, Chloride, Cholesterol, Creatine Kinase, Direct Bilirubin, Glucose, High Density Lipid (HDL), Cholesterol direct, Lipase, Potassium, Sodium, Total Cholesterol, Triglycerides, Urea/Blood Urine Nitrogen.|From start of study treatment until the end of treatment visit for each participant, up to Week 264 for Cohort I and up to Week 228 for Cohort II|Safety Population: all participants that took at least one dose of DTG|||Participants|||Number
1437874|NCT00950859|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF.The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log 10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log 10 c/mL unless <400 c/mL or an increase of >=1.0 log 10 c/mL from nadir; and at or after Week 16, ≥400 c/mL . PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|PDVF Phenotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time of PDVF failure. Only participants with both Baseline and PDVF time-point DTG phenotypic data were considered for analysis.|||Participants|||Number
1437875|NCT00950859|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|From Baseline (Day 1) until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|On-treatment Genotypic Resistance Population: all ITT-E participants who met the criteria for protocol-defined virological failure (PDVF)|||Participants|||Number
1437876|NCT00950859|Secondary|Median Fold Change in Sensitivity to DTG by the Baseline (Day 1) IN Mutational Group|Summary of median fold change in sensitivity to DTG by Integrase (IN) mutational group was assessed. The IN mutational group comprises of the following mutations: Q148 +2, Q148 +1, mixture (participants with virus containing more than one Y143, Q148 or N155 mutation at Day 1), Y143, N155, other (participants with virus having no mutations at codons 143, 148, or 155 at Day 1). Fold change (FC) is the fold change in 50% Inhibitory Concentration (IC50) relative to the wild-type control virus.|Baseline (Day 1)|ITT-E Population|||Percentage||Full Range|Median
1437877|NCT00950859|Secondary|Number of Participants With the Indicated Genotypic Resistance at Baseline|At Baseline, the integrase genotypic results were used to document resistance to raltegravir (RAL) and for the allocation of participants to one of two genotypic groups according to their RAL signature mutations to ensure a broad range of sensitivity to DTG. These results were not used to pre-define subgroup for analysis.|Baseline|ITT-E Population|||Participants|||Number
1437878|NCT00950859|Secondary|Number of Participants (Cumulative) With Protocol-defined Virological Failure (PDVF) at Day 11 and Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, Week 108 Every 12 Weeks up to Study Completion|PDVF is defined in relation to Baseline plasma HIV-1 RNA levels: at Day 11, a decrease of <0.7 log10 c/mL unless <400 c/mL; at Weeks 8 to <16, a decrease of <1.0 log10 c/mL unless <400 c/mL or an increase of >= 1.0 log10 c/mL from nadir; and at or after Week 16, ≥400 c/mL. PDVF at Day 11 was based on a single plasma HIV-1 RNA evaluation and did not require confirmation. Confirmation testing was required for visits at or after Week 8. For the combination treatment phase, all HIV-1 RNA samples that meet a criterion for suspected PDVF must be confirmed by a second measurement performed at least 1 week but not more than 4 weeks apart from the date of the original sample.|Day 11; Weeks 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population|||Participants|||Number
1437879|NCT00950859|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shifts to CDC Class C or Death|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population.|||Participants|||Number
1437880|NCT00950859|Secondary|Number of Participants With the Indicated HIV-1 Associated Conditions, Excluding Recurrences|The number of participants with post-Baseline emergent HIV-1 disease progression (Acquired immunodeficiency syndrome (AIDS) or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until study completion (median 605 days for Cohort I, median 1181 days for Cohort II)|ITT-E Population. Participant may have more than one HIV associated condition. Each condition is counted only once per participant, regardless of recurrence.|||Participants|||Number
1437881|NCT00950859|Secondary|AUC0-24 Assessment of DTG|AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to 24 hours. AUC0-24 of DTG was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population|||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1437882|NCT00950859|Secondary|Tmax of DTG|The tmax is defined as the time of occurrence of the maximum plasma concentration (Cmax). The tmax was assessed at Day 10. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|PK Parameter Population|||Hours||Full Range|Median
1437883|NCT00950859|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 10, and Weeks 4 and 24. Blood samples for pharmacokinetic assessments were collected at pre-dose (within 15 minutes prior to dose).|Day 10; Weeks 4 and 24|PK Parameter Population|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1437884|NCT00950859|Secondary|Cmax, Cmin, and Ctau of DTG|The maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Day 10. Blood samples for pharmacokinetic (PK) assessments were collected at pre-dose (within 15 minutes prior to dose) and 2, 3, 4, 8, and 24 hours post-dose on Day 10 for DTG 50 mg OD and pre-dose (within 15 minutes prior to dose) and 2, 3, 4 and 8 hours post morning dose and 12 hours post evening dose for DTG 50 mg BID.|Day 10|Pharmacokinetic (PK) Parameter Population: all participants who provided at least one evaluable PK concentration|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1437885|NCT00950859|Secondary|Change From Baseline in CD4+ Cell Count at Day 11 and Weeks 4, 12, 24, 48, 72, 96, Week 108 Every 12 Weeks up to Study Completion|Change from Baseline in CD4+ cell count was assessed at Day 11 and at Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 . Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 11; Weeks 4, 12, 24, 48, 72, 96, from Week 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X in the category titles).|||cells per cubic millimeter (mm^3)||Full Range|Median
1437886|NCT00950859|Secondary|Proportion of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion|ITT-E Population|||Percentage of Participants|||Number
1437887|NCT00950859|Secondary|Number of Participants Who Achieved Plasma HIV-1 RNA <400 c/mL and <50 c/mL at Baseline and Weeks 4, 12, 24, 48, 72, and 96: TLOVR Analysis.|The number of participants with plasma HIV-1 RNA <400 c/mL or <50 c/mL was assessed at Weeks 4, 12, 24, 48, 72, and 96 per the Food and Drug Administration's Time to Loss of Virological Response (TLOVR) algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.|Baseline; Weeks 4, 12, 24, 48, 72, and 96|ITT-E Population|||Participants|||Number
1437888|NCT00950859|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 6 to 8, Day 11, Weeks 4, 12, 24, 48, 72, 96, From Week 108 Every 12 Weeks up to Study Completion|Mean change from Baseline in Plasma HIV-1 RNA was assessed on Day 6 to 8, Day 11, and Weeks 4, 12, 24, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, and 264 using data of the observed cases. Study Day 1 was considered as Baseline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 6 to 8; Day 11; Weeks 4, 12, 24, 48, 72, 96, from 108 every 12 weeks up to study completion|ITT-E Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).|||Log10 copies/mL||Standard Deviation|Mean
1437889|NCT00950859|Primary|Number of Participants Who Achieved HIV-1 RNA <400 Copies (c)/Milliliter (mL) or at Least 0.7 log10 c/mL Below Their Baseline Value at Day 11|The number of participants who acheived Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11 was assessed. The last observation was carried forward if a participant had missed the Day 11 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 11. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 11.|Baseline (Day 1) and Day 11|Intent-to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of study medication and who had at least one post-Baseline measure of plasma HIV-1 RNA.|||Participants|||Number
1437891|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes) in Nasopharyngeal Swabs|Frequency of acquisition of new non- vaccine, non-cross-reactive serotypes in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
1437892|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Cross-reactive Serotypes) in Nasopharyngeal Swabs|Frequency of acquisition of new cross-reactive serotypes in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
1437893|NCT00950833|Secondary|Number of Subjects With New Acquisition of S. Pneumoniae (Vaccine Serotypes) in Nasopharyngeal Swabs|Frequency of acquisition of new Synflorix™ vaccine serotypes in the nasopharynx was done per group at the same swab time-point.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Participants|||Count of Participants
1437894|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With Haemophilus Influenzae|Positive cultures of H. influenzae identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs|||Number
1437895|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)|Positive cultures of S. pneumoniae non- Synflorix™ vaccine, non-cross-reactive serotypes identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs|||Number
1437896|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)|Positive cultures of S. pneumoniae cross- reactive serotypes identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs|||Number
1437897|NCT00950833|Secondary|Number of Nasopharyngeal Swabs With Streptococcus Pneumoniae (Vaccine Serotypes)|Positive cultures of S. pneumoniae Synflorix™ vaccine serotypes identified in the nasopharynx were recorded and the percentage of subjects with positive nasopharyngeal samples was calculated.|At 31-44 months of age and prior to the first vaccine dose, at 40-48 months of age|The analysis was performed on the ATP cohort for carriage, which included all evaluable subjects for whom carriage outcome measures were available after the swab time point.|||Swabs|||Number
1437898|NCT00950833|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Month 10 or Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1437899|NCT00950833|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1437900|NCT00950833|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the unprimed group.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1437901|NCT00950833|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as causally related to study vaccination. This outcome measure refers only to the primed groups.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1438333|NCT00947531|Secondary|Change From Baseline in Clock-drawing Test|The Clock-drawing test is a frequently used screening instrument for dementia drug studies. It evaluates executive function of demented patients.|week 4, 12, 16, 24|||||||
1437902|NCT00950833|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the unprimed group.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1437903|NCT00950833|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure refers only to the primed groups.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1437904|NCT00950833|Secondary|Rabbit Complement-mediated Serum Bactericidal Activity Titers Against Neisseria Meningitidis Serogroups (rSBA-Men)|The Neisseria meningitidis serogroups assessed using rabbit complement were: A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY), presented as geometric mean titers (GMTs). The seropositivity cut-off of the assay was an antibody titer ≥ 8.|At 25-36 months post-vaccination in previous 107137 (NCT00496015) study|The analysis was performed on the ATP cohort for antibody persistence, which included all subjects with the vaccine administration documented, for whom assay results were available for antibodies against each considered antigen for the blood sample taken before the administration of Synflorix™ vaccine.|||Titers||95% Confidence Interval|Geometric Mean
1437905|NCT00950833|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1437906|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1437907|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A|The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1437908|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F).|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1437909|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs), expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|At Month 12, one month after the second vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1437910|NCT00950833|Secondary|Memory B-cell Detection for Vaccine Polysaccharides (PS)|B-cell detection for the pneumococcal serotype specific polysaccharides (1, 5, 6B, 18C, 19F, 23F and C) was tabulated for a subset of subjects from each group. The results are expressed as the frequencies of antigen-specific memory B-cells within the total memory B-cell population.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Memory B-cells||Standard Deviation|Mean
1437911|NCT00950833|Secondary|Antibody Concentrations Against Protein D (Anti-PD)|Anti-protein D (anti-PD) concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value of the assay was an antibody concentration ≥ 100 EL.U/mL.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against protein D were available after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1438334|NCT00947531|Secondary|Change From Baseline in Trail-making Test|The Trail-making test is a frequently used instrument for the assessment of executive function.|week 4, 12, 16, 24|||||||
1437912|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A|Seropositivity status was defined as the opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A (Opsono-16A and opsono-19A) ≥ the value of 8, presented as geometric mean titers (GMTs).|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1437913|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Cross-reactive Serotypes 6A and 19A|The vaccine pneumococcal cross-reactive serotypes 6A and 19A have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1437914|NCT00950833|Secondary|Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes|Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes ≥ the value of 8, presented as geometric mean titers (GMTs). The vaccine pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F).|Prior to (Day 0) and 7-10 days after the first vaccine dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1437915|NCT00950833|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition ELISA, presented as GMCs and expressed in μg/mL. The seropositivity cut-off value of the assay was an antibody concentration ≥ 0.05 μg/mL.|Prior to the first study vaccine dose (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1437916|NCT00950833|Primary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -6B, -7F, -9V, -14, -18C, -19F and -23F) have been assessed by 22F-inhibition enzyme linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.|At 7-10 days after the first vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one pneumococcal vaccine serotype were available after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1437917|NCT00950807|Secondary|Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period|Serial FEV1 for OQ dosing is recorded at the pre-AM dose (time 0 h) and at 1, 3, 6, 9, 12,13, 15, 18, 21, 24 and 28 hs after the AM dose on D 14. For BID dosing, the 12 h AM dose corresponds to the pre-PM dose, 13 h AM dose corresponds to the 1 h PM dose, 15 h AM dose corresponds to the 3 h PM dose, 18 h AM corresponds to the 6 h PM dose, 21 h AM dose corresponds to 9 h PM dose, 24 h AM dose corresponds to the 12 h PM dose and 28 h AM dose corresponds to the 16 h PM dose in the table. Analysis performed using a mixed model with covariates of mean BL, period BL, trt, period, time, time by period BL interaction, time by mean BL interaction and time by trt interaction as fixed effects and par. as a random effect. BL is the FEV1 value recorded pre-dose on D 1 of each TP; mean BL is the mean of the BLs for each par. and period BL is the difference between the BL and the mean BL in each TP for each par. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.|||Liters||Standard Deviation|Mean
1437918|NCT00950807|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour (h) post-dose measurements at Day 14 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24 hours. Analysis performed using a mixed model with covariates mean BL, period BL, treatment and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP; mean BL is the mean of the BLs for each participant and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.|Baseline and Day 14 of each treatment period (TP; up to Study Day 70)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 14.|||Liters||Standard Error|Least Squares Mean
1437944|NCT00950742|Secondary|Progression Free Survival (PFS)|PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.|Baseline until disease progression, death or data cut-off.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Days||95% Confidence Interval|Median
1437919|NCT00950807|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Baseline and Day 15 of each treatment period (up to Study Day 71)|Modified Intent-To-Treat (mITT) Population: all participants randomized to treatment who received at least one dose of study medication. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.|||Liters||Standard Error|Least Squares Mean
1437920|NCT00950755|Secondary|Number of Days Each Participant Took to Reach Hypothyroidism After the First Dosimetric Dose|Hypothyroidism is a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants experiencing hypothyroidism were analyzed.|||days|||Number
1437921|NCT00950755|Secondary|Number of Participants in the Indicated Categories of Thyroid Function Assessment|Hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone (resulting in the elevation of thyroid stimulating hormone [TSH] in the blood), may result from treatment with radioactive iodine I 131. A thyroid blockade medication was given prior to administration of the study drug and up to 2 weeks after the therapeutic dose to prevent the uptake of I 131 in the thyroid gland. Thyroid function was determined periodically, including during follow-up, in order to assess if there was any effect of the I 131 on thyroid function, such as hypothyroidism.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who were evaluable for thyroid function assessment and who had no elevated TSH level or hypothyroidism at baseline were analyzed.|||participants|||Number
1437922|NCT00950755|Secondary|Time to HAMA Positivity From First Dosimetric Dose|Time to HAMA positivity is defined as the time from the first dosimetric dose to the first reported HAMA-positive result for the participant.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.|||days||Full Range|Median
1437923|NCT00950755|Secondary|Number of Participants Who Became Positive or Negative for Human Anti-murine Antibody (HAMA) After Study Treatment|Tositumomab is a murine (mouse) antibody. Participants in this study were evaluated to determine if they developed a human anti-murine antibody (HAMA) immune response after administration of tositumomab and iodine I 131 tositumomab.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population|||participants|||Number
1437924|NCT00950755|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).|||g/dL||Full Range|Median
1437925|NCT00950755|Secondary|Nadir Values for Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).|||1000 cells/millimeters cubed (mm^3)||Full Range|Median
1437926|NCT00950755|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to nadir and time to recovery to baseline. Hematologic toxicity is defined as laboratory values outside the normal range (different for each parameter).|||days||Full Range|Median
1437945|NCT00950742|Secondary|Number of Patients With Best Overall Response|Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
1437927|NCT00950755|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|"ITT Exposed Population. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."|||days||Full Range|Median
1437928|NCT00950755|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.|||participants|||Number
1437929|NCT00950755|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population|||participants|||Number
1437930|NCT00950755|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. All participants who experienced any SAE were analyzed.|||participants|||Number
1437931|NCT00950755|Secondary|Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population|||participants|||Number
1437932|NCT00950755|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
1437933|NCT00950755|Secondary|Time to Treatment Failure as Assessed by the Investigator|Time to treatment failure is defined as the length of time from the date of enrollment to the first incidence of treatment withdrawal, study removal, progression, and/or alternative therapy for the participant's lymphoma, or death.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced treatment failure were evaluated.|||months||95% Confidence Interval|Median
1437934|NCT00950755|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. New lesions must be greater than 2 x 2 centimeters (cm) in diameter by radiographic evaluation or greater than 1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants who experienced progression were evaluated.|||months||95% Confidence Interval|Median
1437946|NCT00950742|Secondary|Number of Patients With Objective Response (OR)|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).|Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
1438335|NCT00947531|Secondary|Change From Baseline in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale)|The ADCS-ADL is a measure of functional disability. The ADCS-ADL assessment of activities of daily living is based on an interview with the caregiver.|week 4, 12, 16, 24|||||||
1437935|NCT00950755|Secondary|Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Duration of response is defined as the time from the first documented response until disease progression. Disease progression is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
1437936|NCT00950755|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.|||participants|||Number
1437937|NCT00950755|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >4 weeks apart. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 centimeters (cm) in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease (EOD) must be unchanged or decreased upon follow-up evaluations. If the EOD was unchanged or if further decreases occurred for >=6 months, the participant was reclassified as having a CR.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.|||participants|||Number
1437938|NCT00950755|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1437939|NCT00950755|Primary|Number of Participants With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
1437940|NCT00950755|Primary|Number of Participants (Par.) With Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or 2 years in Study BEX104505. Par. who completed 2 years in BEX104505 were followed in study BEX104528 for up to 125 months. Data are included from both Study BEX104505 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.|||participants|||Number
1437941|NCT00950742|Secondary|Summary of Concentration of Herceptin in Plasma|Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1437942|NCT00950742|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||hours||Full Range|Median
1437943|NCT00950742|Secondary|Summary of Concentration of Afatinib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).|0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438001|NCT00950599|Secondary|Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control|Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)|Week 4, Week 6|||||||
1437947|NCT00950742|Primary|Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R)|The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.|28 days|TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.|||mg|||Number
1437948|NCT00950742|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.|28 days|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib. 3 patients were excluded as they were not evaluable for determination of maximum tolerated dose.|||Participants|||Number
1437949|NCT00950729|Primary|Mean Breaking Force Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking force during emergency braking with and without distractor|June 2007 to September 2007||||pounds||Standard Deviation|Mean
1437950|NCT00950729|Primary|Mean Breaking Time Measured on a Driving Car Simulator|computerized driving simulator was used to measure the braking reaction time and the total braking time during emergency braking with and without a distracter.|June 2007 to September 2007||||seconds||Standard Deviation|Mean
1437951|NCT00950690|Primary|Humphrey Perimetry Visual Field|Analysis of visual field deficits for abnormalities.|Visits 1 and 4|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.|||decibels||Standard Deviation|Mean
1437952|NCT00950690|Primary|Intraocular Pressure|Intraocular pressure was measured at each visit|Screening, 10 days, 4 weeks and 12 weeks after beginning treatment|Data collection process did not permit clear identification of IOP & visual field data in non-monitored study. Efficacy data not sufficiently interpretable for statistical summaries.|||millimeters of mercury||Standard Deviation|Mean
1437953|NCT00950664|Other Pre-specified|Reduction of Pain Associated With Cervical Dystonia at Each Visit From Baseline|Pain subscale of TWSTRS scale.(Range: 0-20) Negative numbers to represent decreases of TWSTRS pain subscale.|4, 8, 12 and 16 weeks after injection||||units on a scale||Standard Deviation|Mean
1437954|NCT00950664|Other Pre-specified|Reduction of Total TWSTRS at Each Visit From Baseline|TWSTRS scale (Toronto western spasmodic torticollis rating scale, range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS scale.|8, 12 and 16 weeks after injection||||units on a scale||Standard Deviation|Mean
1437955|NCT00950664|Secondary|PGI-I (Patient's Global Impression of Improvement)|"The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)~1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated"|4, 8, 12 and 16 weeks after injection||||percentage of patients scoring 1 or 2|||Number
1437956|NCT00950664|Secondary|CGI-I (Clinical Global Impression of Illness)|"The proportion of patients with ‘normal/ not at all ill’ or ‘borderline mildly ill’ on the CGI (Clinical global impression of illness, CGI-I)~1 = normal / not at all ill’; 2 = ‘borderline mildly ill’; 3 = ‘mildly ill’; 4 = ‘moderlately ill’; 5 = ‘markedly ill’; 6 = ‘severely ill’; 7 = ‘the most extremely ill’."|4, 8, 12 and 16 weeks after injection||||percentage of participants scoring 1or2|||Number
1437957|NCT00950664|Other Pre-specified|Reduction of Tsui Score at Each Visit From Baseline|Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.|8, 12 and 16 weeks after injection||||units on a scale||Standard Deviation|Mean
1437958|NCT00950664|Secondary|Reduction of Total TWSTRS Score at 4 Weeks From Baseline|"TWSTRS (Toronto western spasmodic torticollis rating scale) The TWSTRS is a composite scale which covers different features of cervical dystonia(CD).~The first part is based on the physical findings (severity subscale), the second part rates disability, and the third part pain.~(range: 0-80, higher values represent worse cervical dystonia.) Details of the TWSTRS are displayed on the Web site http://www.wemove.org. Negative numbers to represent decreases of TWSTRS."|4 weeks after injection from baseline||||units on a scale||Standard Deviation|Mean
1437959|NCT00950664|Primary|Reduction of Total Tsui Score at 4 Weeks From Baseline|"Tsui scale is an impairment scale which evaluates the amplitude and duration of sustained posture and intermittent movements of the head, as well as the presence of shoulder elevation and tremor.~Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale."|4 weeks after injection from baseline||||units on a scale||Standard Deviation|Mean
1437960|NCT00950651|Secondary|Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty with stairs with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
1437961|NCT00950651|Secondary|Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their difficulty walking with their worst knee using a five-point scale ranging from 1=No problem to 5=Severe difficulty. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
1438002|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6|||||||
1437962|NCT00950651|Secondary|Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated their ability to get things done with their worst knee using a five-point scale ranging from: 1=No problem to 5=A lot of things didn’t get done. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
1437963|NCT00950651|Secondary|Patient Diary: Stiffness (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the stiffness in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
1437964|NCT00950651|Secondary|Patient Diary: Pain (Between Visit Means) at Week 12|As part of the daily diary for the entire study, patients rated the arthritis pain in their worst knee using a five-point scale ranging from 1=none to 5=severe. Mean scores summarizing the entries of the preceding period were calculated.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||Units on a scale||Standard Deviation|Mean
1437965|NCT00950651|Secondary|Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12|The physician was asked to indicate the effectiveness of pain control 24 hours after the most recent dose of tramadol using a 4-point Likert-scale, dichotomized for the analysis: Very Effective, Effective, Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
1437966|NCT00950651|Secondary|Physician Overall Rating: Overall Assessment at Week 12|The physician was asked to indicate his overall assessment of the formulation the patient was taking using a 4-point Likert-scale dichotomized for the analysis: Very Effective, Effective, and Somewhat Effective were summarized to Effective; Ineffective remained unchanged.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
1437967|NCT00950651|Secondary|Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12|Patients who have previously taken tramadol HCl were asked: “Compared to when you were previously taking tramadol, how have any side effects you have felt during this study interfered with your day-to-day activities?”. Possible answers were: “Interfered much less now”, “Interfered somewhat less now”, “Same as before”, “Interfered more now”.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
1437968|NCT00950651|Secondary|Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12|"Patients who have previously taken tramadol HCl were asked to compare how they compare the current pain relief to the pain relief felt when previously taking tramadol, using a 4-point Likert-scale: Worse than before, Same as before, Somewhat better now, or “Much better now”."|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
1437969|NCT00950651|Secondary|Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12|Patients were asked: “How have any side effects you may have felt from the drug interfered with day-to-day activities?” with 4 possible answers: “Significantly”, “Somewhat”, “Minimally”, “Not at all”.|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
1437970|NCT00950651|Secondary|Patient Global Rating of Pain Relief at Week 12|"The Patient Global Rating of Pain is a Likert-scale that answers the question: How do you rate overall pain relief with the drug? with 4 possible answers that were dichotomized: very effective, effective, and somewhat effective were summarized to “effective”; “not effective” remained unchanged."|12 Weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
1437971|NCT00950651|Secondary|Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12|The walking test is a measure of how many seconds it takes the patient to walk a distance of 15 meters. The change from baseline to week 12 was calculated.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437972|NCT00950651|Secondary|Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12|Patients indicated their Average Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437973|NCT00950651|Secondary|Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12|Patients indicated their Worst Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437974|NCT00950651|Secondary|Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12|Patients indicated their Least Pain Within Last 24 Hours using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437975|NCT00950651|Secondary|Percentage of Change From Baseline in Current Pain at Week 12|Pain Visual Analogue Scales: Current Pain. Patients indicated their current pain using a 100mm VAS scale ranging from 0=no pain to 100=extreme pain. The percentage of change in current pain was calculated from baseline to week 12. In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437976|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Total Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Each item is rated on a 100mm VAS scale (0mm=no pain/stiffness/difficulty to 100mm=extreme no pain/stiffness/difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437977|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Physical Function subscale score consists of 17 items rated on a 100mm VAS scale (0mm=no difficulty to 100mm=extreme difficulty). In case of premature discontinuation, the last assessment was used to calculate percentage of change|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437978|NCT00950651|Secondary|Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. Stiffness subscale score consists of 2 items each rated on 100mm VAS scale (0mm=no stiffness to 100mm=extreme stiffness). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437979|NCT00950651|Secondary|Arthritis Pain at the End of Dosing Interval (24-hour Efficacy)|Each day before morning dose, patients assessed arthritis pain in worst knee in a diary using a 5-point rating scale ranging from none to severe. A median score was estimated for each patient each week and re-categorized into different degrees of pain (rounding off to the closest integer). Results are of 12th week (day 78-84).|12 weeks|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||participants|||Number
1437980|NCT00950651|Primary|Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12|The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.|Baseline to week 12|Per protocol population: patients who completed study, had no major protocol deviations before/during trial and had primary efficacy variable rating at end of study. Early drop-outs due to AEs / lack of efficacy were included if they took study drug for >2weeks in maintenance phase and had efficacy assessments within 2 days after end of study drug.|||percentage of change||Standard Deviation|Mean
1437981|NCT00950612|Secondary|Anti-M72 Specific Antibody Concentrations|Antibody concentrations given in Enzyme-Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) were expressed as Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1437982|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1437983|NCT00950612|Secondary|Frequency of M72 Specific CD8+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1437984|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1437985|NCT00950612|Secondary|Frequency of M72 Specific CD4+ T Cells Expressing Any Combination of Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L], after background reduction stimulated by M72. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1437986|NCT00950612|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2], interferon-gamma [IFN-γ], tumour necrosis factor-alpha [TNF-α] and cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry, using intracellular cytokine staining (ICS).|At Day 0, 7, 30, 37, 60 and 210|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/placebo according to their random assignment, for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
1437987|NCT00950612|Primary|Number of Subjects With Haematological Levels Below Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437988|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Below Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437989|NCT00950612|Primary|Number of Subjects With Haematological Levels Above Normal|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437990|NCT00950612|Primary|Number of Subjects With Biochemical and Haematological Above Normal Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437991|NCT00950612|Primary|Number of Subjects With Normal Haematological Levels|"Among haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC].~Levels of haematological parameters assessed in terms of normal laboratory values were – normal, below and above."|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1438495|NCT00946088|Secondary|Number of Days Delay of Delivery|Number of days from intervention to delivery|Up to the time of delivery|exact delivery data unavailable for one term participant|||days||Full Range|Median
1437992|NCT00950612|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CREA], haemoglobin [Hgb]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performedon the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437993|NCT00950612|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 210)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437994|NCT00950612|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437995|NCT00950612|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437996|NCT00950612|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Subjects|||Number
1437997|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.|||Percentage of participants|||Number
1437998|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations|All participants treated during the follow-up period.|||Percentage of participants|||Number
1437999|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.|||Percentage of participants|||Number
1438000|NCT00950599|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations|All participants randomized and treated during the double-blind period.|||Percentage of participants|||Number
1438003|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort|Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort. (Note: this analysis was not performed.)|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.||||||
1438004|NCT00950599|Secondary|Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort|Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 & 100 mg cohort.|Week 6|Randomized participants. To be included in the Week 6 LOCF analysis, subjects must have had at least 1 post-baseline measurement.|||Percentage of Participants|||Number
1438005|NCT00950599|Secondary|Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort|Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6, participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Deviation|Mean
1438006|NCT00950599|Secondary|Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Deviation|Mean
1438007|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 & 100 mg cohort.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percent||Standard Deviation|Mean
1438008|NCT00950599|Secondary|Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)|||umol/L||Standard Deviation|Mean
1438009|NCT00950599|Secondary|Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 or Week 8, participants must have had a baseline and at least 1 post-baseline measurement. The Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).|||umol/L||Standard Deviation|Mean
1438010|NCT00950599|Secondary|Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)|||mg/dL||Standard Deviation|Mean
1438011|NCT00950599|Secondary|Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 8, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).|||mg/dL||Standard Deviation|Mean
1438012|NCT00950599|Secondary|Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 & 100 mg cohort.|Baseline, Week 10, Week 16|Randomized participants. To be included in analysis of change from baseline to Week 16 (0-40 mg cohort) and Week 10 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 16 and Week 10 assessments are the assessments closest to the respective target date (or later assessment in the case of a tie)|||percentage of glycated hemoglobins||Standard Deviation|Mean
1438013|NCT00950599|Secondary|Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 & 100 mg cohort.|Baseline, Week 14|Randomized participants. To be included in analysis of change from baseline to Week 14 (0-40 mg cohort) or Week 8 (0&100 mg cohort), participants must have had a baseline and at least 1 follow-up period measurement. Week 14 and Week 8 assessments are the assessments closest to the respective target dates (or later assessments in the case of a tie).|||percentage of glycated hemoglobins||Standard Deviation|Mean
1438496|NCT00946088|Secondary|Neonatal Congenital Abnormalities||Up to the time of neonatal discharge from the delivery hospital||||Neonates|||Number
1438497|NCT00946088|Secondary|Neonatal Mortality||Up to 28 days after neonatal birth||||Participants|||Count of Participants
1438014|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1438015|NCT00950599|Secondary|Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1438016|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1438017|NCT00950599|Secondary|Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.|Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1438018|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1438019|NCT00950599|Secondary|Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Deviation|Mean
1438020|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEq/mL||Standard Error|Mean
1438021|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEq/mL||Standard Error|Mean
1438022|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
1438023|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
1438024|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEg/L||Standard Error|Mean
1438498|NCT00946088|Secondary|Neonatal Morbidity||Up to 28 days after neonatal birth||||Participants|||Count of Participants
1438025|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mEg/L||Standard Error|Mean
1438026|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
1438027|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||pg/mL||Standard Error|Mean
1438028|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438029|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438030|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438031|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438032|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438033|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438034|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438035|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438036|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438336|NCT00947531|Secondary|Change From Baseline in MMSE (Mini-Mental State Examination) Score|The Mini-Mental State Examination (MMSE) is a frequently used screening instrument for clinical trials conducted in patients with Alzheimer’s Disease. It evaluates orientation, registration, attention and calculation, recall and language.|week 4, 12, 16, 24|||||||
1438037|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438038|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438039|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438040|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438041|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438042|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438043|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438044|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438045|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438046|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438047|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438048|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438337|NCT00947531|Secondary|CIBIS+ (Clinicians Interview-Based Impression of Severity)|The Clinician Interview-based Impression of Disease Severity (CIBIS+) score is assigned by an experienced physician, familiar with the manifestations of dementia, after interviewing the patient and the caregiver.|week 24|||||||
1438049|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438050|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438051|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438052|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438053|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438054|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438055|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438056|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438057|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438058|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438059|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438060|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438061|NCT00950599|Secondary|Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438062|NCT00950599|Secondary|Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438063|NCT00950599|Secondary|Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438064|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng*min/mL||Standard Error|Mean
1438065|NCT00950599|Secondary|Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng*min/mL||Standard Error|Mean
1438066|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU*min/mL||Standard Error|Mean
1438067|NCT00950599|Secondary|Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU*min/mL||Standard Error|Mean
1438068|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg*min/dL||Standard Error|Mean
1438069|NCT00950599|Secondary|Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg*min/dL||Standard Error|Mean
1438070|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438071|NCT00950599|Secondary|Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||ng/mL||Standard Error|Mean
1438499|NCT00946088|Secondary|Neonatal Intensive Care Unit (NICU) Admission||At time of neonatal discharge||||Participants|||Count of Participants
1438073|NCT00950599|Secondary|Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||uU/mL||Standard Error|Mean
1438074|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||umol/L||Standard Error|Mean
1438075|NCT00950599|Secondary|Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||umol/L||Standard Error|Mean
1438076|NCT00950599|Secondary|Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438077|NCT00950599|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||mg/dL||Standard Error|Mean
1438078|NCT00950599|Secondary|Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 & 100 mg cohorts.|Baseline, Week 6|Randomized participants. To be included in analysis of change from baseline to Week 6 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percentage of glycosylated hemoglobins||Standard Error|Mean
1438079|NCT00950599|Primary|Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort|Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.|Baseline, Week 12|Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percentage of glycosylated hemoglobins||Standard Error|Mean
1438080|NCT00950599|Primary|Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort|Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.|Baseline, Week 12|Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.|||percentage of glycosylated hemoglobins||Standard Deviation|Mean
1438081|NCT00950352|Secondary|Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.|Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.|Throughout the course of the study|||||||
1438082|NCT00950352|Secondary|Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.|Phosphorus-31 ((31)P) magnetic resonance spectroscopy (MRS) was used to evaluate changes in mitochondrial high energy phosphates, including phosphocreatine (PCr) and β-nucleoside triphosphate (β-NTP, primarily ATP in brain) levels.|Neuroimaging will occur at week 0 and week 8/9|||||||
1438083|NCT00950352|Secondary|Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.|Cognitive measurement tests will be employed.|Neuropsychological testing will occur at week 0 and week 8/9|||||||
1438084|NCT00950352|Primary|Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo|Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.|8 weeks, assessed twice weekly starting week1||||total amount consumed in grams||Standard Deviation|Mean
1438085|NCT00950300|Secondary|Number of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)|Participants in the Herceptin SC arm provided PK samples for evaluation of anti-rHuPH20 antibodies. The number of participants with “Treatment-induced ADAs” and “Treatment-enhanced ADA” against rHuPH20 (an excipient unique to the SC formulation) at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer).|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18|Safety Population; as rHuPH20 is unique to SC formulation, this outcome measure was applicable for “Herceptin SC + Chemotherapy” arm only. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1438095|NCT00950300|Secondary|Tmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Tmax during Cycle 12 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.|||days||Standard Deviation|Mean
1438086|NCT00950300|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab|Participants provided PK samples for evaluation of anti-trastuzumab antibodies. The number of participants with “Treatment-induced ADAs” and “Treatment-enhanced ADA” against trastuzumab at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer).|Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18|Safety Population: All participants who received at least one dose of study medication. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
1438087|NCT00950300|Secondary|Overall Survival (OS)|OS was estimated by Kaplan-Meier analysis and defined as the time from randomization to death from any cause.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||months||Full Range|Median
1438088|NCT00950300|Secondary|Percentage of Participants Who Died|The percentage of participants who died at any time during the study was reported.|Continuously during treatment (up to 12 months); at Months 1, 3, 6 from last dose of Cycle 18 (cycle length of 21 days); then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||percentage of participants|||Number
1438089|NCT00950300|Secondary|Event-Free Survival (EFS)|Protocol-defined events included disease recurrence or progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. EFS was estimated by Kaplan-Meier analysis and defined as the time from randomization to the first protocol-defined event.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||months||Full Range|Median
1438090|NCT00950300|Secondary|Percentage of Participants Who Experienced a Protocol-Defined Event|Protocol-defined events included disease recurrence/progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. The percentage of participants who experienced a protocol-defined event at any time during the study was reported.|Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)|ITT Population|||percentage of participants|||Number
1438091|NCT00950300|Secondary|Time to Response According to RECIST Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm with no prior assessment of PD. PR was defined as ≥30% decrease from Baseline in SD of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. Time to response was defined as the time from first dose of study medication to the first assessment of CR or PR, which was the date the response was first documented by objective evidence, among participants with an overall response of CR or PR.|Tumor assessments at Baseline; on Day 1 Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline and a response of CR or PR were included.|||weeks||Full Range|Median
1438092|NCT00950300|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline|Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm) with no prior assessment of progressive disease (PD). PR was defined as greater than or equal to (≥) 30% decrease from Baseline in sum diameter (SD) of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. The percentage of participants with overall response of CR or PR at the end of neoadjuvant treatment was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|Tumor assessments at Baseline; on Day 1 of Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months overall)|EPP Population; only participants with measurable disease at Baseline were included.|||percentage of participants||95% Confidence Interval|Number
1438093|NCT00950300|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination. The percentage of participants with tpCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|EPP Population|||percentage of participants||95% Confidence Interval|Number
1438094|NCT00950300|Secondary|AUC21d of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 12 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in d*μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.|||d*μg/mL||Standard Deviation|Mean
1438113|NCT00950183|Secondary|Narcotic Pain Medication Usage||postop day 1 up to postop day 14|Data not analyzed due to study termination.||||||
1438114|NCT00950183|Primary|Visual Analog Scale (VAS) Pain Scores||postop day 1 up to postop day 14|Data not analyzed due to study termination||||||
1438096|NCT00950300|Secondary|Cmax of Trastuzumab After Surgery|PK samples were obtained after surgery (Cycle 12). The Cmax during Cycle 12 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 12; on Days 2, 4, 8, 15 of Cycle 12; pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population; only those participants who provided evaluable data were included.|||μg/mL||Standard Deviation|Mean
1438097|NCT00950300|Secondary|Area Under the Concentration-Time Curve From 0 to 21 Days (AUC21d) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). Values were extrapolated beyond Day 15 to produce the area over the full 21-day cycle. The AUC21d value at Cycle 7 was calculated from trastuzumab concentration-time profiles using standard non-compartmental PK methods, averaged among all participants, and expressed in days multiplied by micrograms per milliliters (d*μg/mL).|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.|||d*μg/mL||Standard Deviation|Mean
1438098|NCT00950300|Secondary|Time of Maximum Serum Concentration (Tmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Tmax during Cycle 7 was recorded, averaged among all participants, and expressed in days.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.|||days||Standard Deviation|Mean
1438099|NCT00950300|Secondary|Maximum Serum Concentration (Cmax) of Trastuzumab Prior to Surgery|PK samples were obtained prior to surgery (Cycle 7). The Cmax during Cycle 7 was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) and at end of 30-minute infusion (Herceptin IV only) on Day 1 of Cycle 7; on Days 2, 4, 8, 15 of Cycle 7; pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population; only those participants who provided evaluable data were included.|||μg/mL||Standard Deviation|Mean
1438100|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population|||participants|||Number
1438101|NCT00950300|Secondary|Number of Participants With Ctrough of Trastuzumab >20 μg/mL Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The number of participants who had an observed Ctrough >20 μg/mL was reported.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary PKPP Population|||participants|||Number
1438102|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab After Surgery|Predicted Ctrough at pre-dose after surgery (Cycle 13) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|PKPP Population; only participants with a Cycle 13 pre-dose PK measurement were included in the analysis.|||μg/mL||Standard Deviation|Mean
1438103|NCT00950300|Secondary|Predicted Ctrough of Trastuzumab Prior to Surgery|Predicted Ctrough at pre-dose prior to surgery (Cycle 8) was determined on the basis of a population PK model from Study BP22023 (NCT00800436). The mean predicted Ctrough was expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|PKPP Population: All participants with at least one measurable trastuzumab serum concentration.|||μg/mL||Standard Deviation|Mean
1438104|NCT00950300|Secondary|Observed Ctrough of Trastuzumab After Surgery|Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)|Secondary PKPP Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the secondary endpoint.|||μg/mL||Standard Deviation|Mean
1438105|NCT00950300|Primary|Percentage of Participants With Pathological Complete Response (pCR)|Participants were evaluated following eight cycles of treatment and after surgery to assess for pCR, defined as absence of neoplastic invasive cells in the breast according to pathologist examination. The percentage of participants with pCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.|After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)|Efficacy (E) PP Population: All participants with at least one on-treatment efficacy assessment who received a full eight cycles of study treatment according to randomization and who met additional protocol-specified criteria.|||percentage of participants||95% Confidence Interval|Number
1438106|NCT00950300|Primary|Observed Serum Trough Concentration (Ctrough) of Trastuzumab Prior to Surgery|Pre-dose samples were obtained prior to surgery (Cycle 8). The observed Ctrough was recorded, averaged among all participants, and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) on Day 1 of Cycle 8 (cycle length of 21 days)|Primary Pharmacokinetic (PK) Per Protocol (PP) Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the primary endpoint.|||μg/mL||Standard Deviation|Mean
1438107|NCT00950235|Secondary|Large for Gestational Age (LGA)|Large-for-gestational-age defined as weight greater than the 90th percentile for gestational age at birth.|At birth|Babies born to participants|||participants|||Number
1438108|NCT00950235|Secondary|Pregnancy Weight Change||baseline to 34 weeks gestation|Participants returning for follow up visit or validated clinical data|||kg||Standard Deviation|Mean
1438109|NCT00950235|Primary|Maternal Weight Change|We chose the weight at 2 weeks postpartum, rather than at an end point during pregnancy, to avoid the contribution of products of conception, maternal edema, and increased maternal blood volume to the weight gain.|baseline to 2 weeks post partum|Data was from follow up visit or validated clinical data|||kg||Standard Deviation|Mean
1438110|NCT00950183|Secondary|Postoperative Complications||postop day 1 up to postop day 14|Data not analyzed due to study termination||||||
1438111|NCT00950183|Secondary|Surgical Complications||Day of Surgery|Data not analyzed due to study termination||||||
1438112|NCT00950183|Secondary|Patient Satisfaction||first postoperative visit (between postop day 10 and 14)|Data not analyzed due to study termination||||||
1438115|NCT00949975|Secondary|Exacerbations - Clinic Defined|Number of patients having a clinic defined disease exacerbation|Duration of the the treatment period - 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Participants|||Number
1438116|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - End-value Overall Score|St George’s Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
1438117|NCT00949975|Secondary|St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline|St George’s Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Deviation|Mean
1438118|NCT00949975|Secondary|Six-minute Walk Test - End-value Distance Walked (m)|distance walked on vist 6 - last on treatment clinic visit|Measured Day 1 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||m||Standard Error|Least Squares Mean
1438119|NCT00949975|Secondary|Six-minute Walk Test - Distance Walked at Baseline (m)||Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||m||Standard Deviation|Mean
1438120|NCT00949975|Secondary|Use of Reliever Medication|Daily average of number of inhalations of reliever medication|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Inhalations||Standard Error|Least Squares Mean
1438121|NCT00949975|Secondary|Sputum Colour - End Value|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12|Measured at clinic visits:1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Error|Least Squares Mean
1438122|NCT00949975|Secondary|Sputum Colour - Baseline|Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1438123|NCT00949975|Secondary|BCSS - End-value Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Error|Least Squares Mean
1438124|NCT00949975|Secondary|BCSS - Baseline Total Score|Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1438125|NCT00949975|Secondary|EXACT - End-value Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.|Measured daily in the evening for 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Error|Least Squares Mean
1438138|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1438126|NCT00949975|Secondary|EXACT - Baseline Total Score|EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
1438127|NCT00949975|Secondary|FEV1 - End-value Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1438128|NCT00949975|Secondary|FEV1 - Baseline Measured by Patient at Home (L) in the Morning|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1438129|NCT00949975|Secondary|PEF - End-value Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min)|Last 6 weeks on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1438130|NCT00949975|Secondary|PEF - Baseline Measured by Patient at Home (L/Min) in the Morning|Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment|Baseline|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Deviation|Mean
1438131|NCT00949975|Secondary|Post-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1438132|NCT00949975|Secondary|Post-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1438133|NCT00949975|Secondary|Pre-bronchodilator IC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1438134|NCT00949975|Secondary|Pre-bronchodilator IC (L) - Baseline|Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1438135|NCT00949975|Secondary|Post-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1438136|NCT00949975|Secondary|Post-bronchodilator FVC (L) - Baseline|Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1438137|NCT00949975|Secondary|Pre-bronchodilator FVC (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1438338|NCT00947531|Secondary|CIBIC+ Response|A patient with a CIBIC+ score of 1 to 3 at a particular visit is considered to have a CIBIC+ response at that visit. Patients with a score of 0, indicating that the assessment was not performed, are considered to be non-responders.|week 4, 12, 16, 24|||||||
1438139|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - End-value|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1438140|NCT00949975|Secondary|Post-bronchodilator FEV1 (L) - Baseline|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1438141|NCT00949975|Primary|End-value Pre-bronchodilator FEV1 (L)|End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)|Measured at clinic visits: 1, 4, 8 and 12 weeks|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1438142|NCT00949975|Primary|Baseline Pre-bronchodilator FEV1 (L)|Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic|Day 1|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Deviation|Mean
1438143|NCT00949910|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.|||months||95% Confidence Interval|Median
1438144|NCT00949910|Secondary|Percentage of Participants Who Died|The percentage of participants (in nearest integer) who died from any cause was reported.|Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
1438145|NCT00949910|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.|||months||95% Confidence Interval|Median
1438146|NCT00949910|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population; only participants with available data were included.|||percentage of participants|||Number
1438147|NCT00949910|Secondary|Percentage of Participants by Best Overall Response According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but <20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is <1) with each type of best overall response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
1438148|NCT00949910|Secondary|Percentage of Participants With Disease Control According to RECIST|Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
1438158|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 4|"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg"|Week 4|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.|||percentage of participants analyzed|||Number
1438500|NCT00946088|Secondary|Birthweight|Newborn birthweight in grams|At the time of newborn birth||||grams||Full Range|Mean
1438149|NCT00949910|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.|Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter|ITT/Safety Population.|||percentage of participants|||Number
1438150|NCT00949884|Other Pre-specified|Change From Baseline to Week 2 in Trough, Cuff, Seated Blood Pressure|The change from baseline in trough systolic and diastolic blood pressure at Week 2 as measured by the Omron monitor. Morning doses of study medication were taken after the exam, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Baseline, Week 2|The efficacy population was defined as participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1438151|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
1438152|NCT00949884|Other Pre-specified|Change From Baseline in Mean Ambulatory Blood Pressure During the Final 2, 4, and 6 Hours of the Dosing Interval at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Systolic and diastolic blood pressure readings taken in the final 2, 4, and 6 hours of the 24-hour ABPM cycle are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
1438153|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 8|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 8 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
1438154|NCT00949884|Other Pre-specified|Change From Baseline in Mean Daytime (8am to 4pm) and Mean Nighttime (10pm to 6am) Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours. Daytime (8am to 4pm) and nighttime (10pm to 6am) systolic and diastolic blood pressure readings are summarized.|Baseline, Week 4|The ambulatory blood pressure monitor (ABPM) population was defined as participants in the efficacy population that had valid baseline and Week 4 ABPM data. Valid (technically successful) ABPM had at least 23 hours of ABPM data.|||mmHg||Standard Error|Least Squares Mean
1438155|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 8|In week 8, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 8|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 8 ABPM data.|||mmHg||Standard Error|Least Squares Mean
1438156|NCT00949884|Other Pre-specified|Change From Baseline in Mean 24-Hour Ambulatory Blood Pressure at Week 4|In week 4, participants arrived at the site in the morning without having taken that day's dose of medication. Once the ambulatory blood pressure monitor (ABPM) had been applied, medication was taken and the participant wore the ABPM for a period of 24-hours.|Baseline, Week 4|The ABPM population was defined as all participants in the efficacy population that had valid (technically successful required at least 23 hours of ABPM data) baseline and Week 4 ABPM data.|||mmHg||Standard Error|Least Squares Mean
1438157|NCT00949884|Other Pre-specified|Percentage of Participants Achieving Blood Pressure Goals at Week 8|"Percentage of participants who achieved the following goals:~Systolic blood pressure: <140 mmHg, <135 mmHg, <130 mmHg, <120 mmHg Diastolic blood pressure: <90 mmHg, <85 mmHg, <80 mmHg Blood pressure: <140/90 mmHg, <135/80 mmHg, <130/80 mmHg, <120/80 mmHg"|Week 8|Efficacy population. Last observation carried forward. Denominator is the number of participants who have seated cuff BP measurement in each treatment group at any visit during the entire randomized treatment phase. Participants randomized to placebo-olmesartan, the measurement is after at least one dose of olmesartan.|||percentage of participants analyzed|||Number
1438339|NCT00947531|Secondary|CIBIC+ Sscore|The Clinician Interview-based Impression of Change (CIBIC+) score is assigned by an experienced physician familiar with the manifestations of dementia after interviewing the patient and the caregiver.|week 4, 12, 16|||||||
1438159|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from Week 4 in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1438160|NCT00949884|Other Pre-specified|Incremental Change From Week 4 to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from Week 4 in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Week 4, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1438161|NCT00949884|Post-Hoc|Percentage of Participants Achieving Ambulatory Blood Pressure Goal of < 135/85 mmHg at Week 8|Participants from pre-selected sites had 24-hour ambulatory blood pressure readings collected. Daytime readings were results collected between 8am and 4pm. Nighttime readings were results collected between 10pm and 6am.|Week 8|Ambulatory Blood Pressure Monitoring (ABPM) Population: All participants in the Efficacy Population that had both valid (technically successful) baseline and Week 8 ambulatory blood pressure monitor data. A technically successful ABPM had at least 23 hours of ABPM data.|||percentage of population|||Number
1438162|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1438163|NCT00949884|Secondary|Change From Baseline to Week 8 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1438164|NCT00949884|Secondary|Change From Baseline to Week 4 in Trough, Cuff, Seated Systolic Blood Pressure (SSBP)|The change from baseline in trough SSBP at Week 4 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 4|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward|||mmHg||Standard Error|Least Squares Mean
1438165|NCT00949884|Primary|Change From Baseline to Week 8 in Trough, Cuff, Seated Diastolic Blood Pressure (SDBP)|The change from baseline in trough SDBP at Week 8 as measured by the Omron monitor. Morning doses of study medication were taken after the exam on study visit days, therefore exam measurements were taken when medication levels were at its lowest ('the trough'). Following a 5-minute rest period, three separate blood pressure measurements were taken with a full 2-minute (not exceeding 5 minutes) interval between measurements, with the cuff fully deflated between measurements. The mean of the 3 seated blood pressure measurements constitute the blood pressure value for the visit.|Day 0, Week 8|The Efficacy Population included participants who received at least 1 dose of double-blind randomized study medication and had a baseline and at least 1 post-baseline blood pressure measurement. Last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1438166|NCT00949715|Secondary|Compare AT/AF Burden From Baseline to 24 Months Follow-up Between the Optimize RV Mid-Septal (RVS) and RV Apex (RVA) Groups.|Test the difference in AT/AF burden (defined as total duration of minutes in AT or AF relative to total patient follow-up days from baseline to 24 months follow-up) between the Optimize RVS and RVA groups. The proportion can be interpreted as the average time per day that patieents were in AT/AF as collected in the time period from baseline to 24 month follow-up.|Whole time from baseline to 24 months averaged by day|All subjects who meet inclusion/exclusion criteria for the study.|||minutes per day||Standard Deviation|Mean
1438167|NCT00949715|Secondary|Compare Change in LV End Systolic Volume After 24 Months Follow-up Between the Optimize RVS Group and RVA Group.|Compare change in 4 chamber LV end systolic volume between baseline and 24 month visit between the Optimize RVS group and RVA group.|24 months|All subjects who had 4 chamber LV end systolic volume at both the baseline and the 24 month time points|||mL||95% Confidence Interval|Mean
1438168|NCT00949715|Secondary|Compare the Change in LVEF From the 2 Week Visit (Collected in Prior Study) to the 24 Month Follow-up Visit Between the Optimize RV Mid-Septum Pacing (RVS) Group and RV Apical Pacing (RVA) Group.|Compare the change in LVEF (in the 4 chamber view) from 2 weeks to 24 months between the Optimize RV Mid-Septum Pacing (RVS) group and RV Apical Pacing (RVA) group.|24 months|Patients that had both 2 week and 24 month follow-up echo data with a 4 chamber LVEF measurement|||percentage of LVEF||95% Confidence Interval|Mean
1438169|NCT00949715|Primary|Difference in Mean Left Ventricular Ejection Fraction (LVEF) Between RV Pacing Sites at 24 Month|Difference in mean LVEF between pacing sites (RV mid-septal minus RV apex) at 24 months using the 4 chamber view|24 months|Subjects who had LVEF measurements from both baseline and 24 month timepoints|||percentage of LVEF||95% Confidence Interval|Mean
1438170|NCT00949702|Secondary|Percentage of Patients With Adverse Event|The intensity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a 5-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening, and Death).|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants|||Number
1438171|NCT00949702|Secondary|Time-matched Change From Baseline in the Study Specific Corrected QT Interval (QTcP)|Three electrocardiograms (ECG) were obtained pre-dose and 2, 4, 6, and 8 hours post-dose at Days 1 and 15 of Cycle 1 and again pre-dose and 4 hours post-dose at various Cycles throughout treatment. Five baseline triplicate ECGs were obtained before the start of treatment at the same time points used during treatment. Reported is the largest mean time-matched QTcP change from baseline. QTcP=QT/(60/heart rate)^β (β=mean [calculated separately for males and females] log-transformed QT versus log-transformed RR regression slopes using all available pre-treatment (baseline) ECG values.|Pre-dose Cycle 1 Day 1 to pre-dose Cycle 6 Day 1|Electrocardiogram (ECG) evaluable population: All treated patients who had a baseline ECG and at least one ECG during treatment.|||ms||95% Confidence Interval|Mean
1438172|NCT00949702|Secondary|Vemurafenib Plasma Levels at Various Treatment Cycles|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and 4 hours post-dose at Day 1 of Cycles 1, 2, 3, 4, 6, 8, and 10. Each Cycle was 3 weeks in duration.|Pre-dose Cycle 1 Day 1 to 4 hours post-dose Cycle 10 Day 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.|||μg/mL||Standard Deviation|Mean
1438173|NCT00949702|Secondary|Vemurafenib Plasma Level Area Under the Curve From 0 to 8 Hours (AUC0-8h) on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin). AUC0-8h was calculated using the linear trapezoidal rule.|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.|||μg⋅h/mL||Standard Deviation|Mean
1438174|NCT00949702|Secondary|Maximum Plasma Concentration (Cmax) of Vemurafenib on Day 15 of Cycle 1|Blood samples for assessing the concentration of vemurafenib in plasma were drawn before the morning dose and at 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1. Pharmacokinetic parameters were estimated by non-compartmental analysis (Win Non-Lin).|Pre-dose to 8 hours post-dose on Day 15 of Cycle 1|Pharmacokinetic population: All patients who received all doses of vemurafenib without dose reduction up to and including Day 15 and who provided at least one of the pharmacokinetic assessments up to and including 8 hours after the first daily dose on Day 15.|||μg/mL||Standard Deviation|Mean
1438175|NCT00949702|Secondary|Improvement in Physical Symptoms (Improvement in Physician’s Assessment of Global Performance Status and Oxygen Saturation Requirements, and Decrease in Total Dose and Frequency of Narcotic Pain Analgesics) During Treatment in Comparison to Baseline|Three parameters were measured. (1) Improvement in the Physician’s Assessment of Global Performance status on a 7-point scale (1=very much better to 7=very much worse). (2) Improvement in oxygen saturation requirements, defined as a clinically meaningful increase in oxygen saturation requirement (from a baseline value < 95% to ≥ 95% saturation using a pulse oximeter). (3) A decrease in total dose and frequency of narcotic pain analgesics. The percentage of patients showing improvement (1 and 2) or a decrease (3) are reported.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants||95% Confidence Interval|Number
1438176|NCT00949702|Secondary|Overall Survival|Overall survival was defined as the time from the date of the first treatment to the date of death, regardless of the cause of death. For patients who were alive at the time of analysis, overall survival was censored at the last date the patient was known to be alive prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||95% Confidence Interval|Median
1438177|NCT00949702|Secondary|Progression Free Survival (PFS) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|PFS was defined the time interval between the date of the first treatment and the date of progression or death from any cause, whichever occurred first. Deaths that occurred in patients without disease progression were considered to be a PFS event on the date of death. Patients who neither progressed nor died were censored on the date of the last evaluable tumor assessment prior to the data cutoff date.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||95% Confidence Interval|Median
1438178|NCT00949702|Secondary|Time to Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Time to response was defined as the interval between the date of the first treatment and the date of the first documentation of confirmed complete response (CR) or partial response (PR), whichever occurred first.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||Inter-Quartile Range|Median
1438340|NCT00947531|Secondary|Change From Baseline for Original ADAS-COG|The Original Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-COG) is comprised of items 1-11 of the modified ADAS-COG+.|week 4, 12, 16, 24|||||||
1438179|NCT00949702|Secondary|Duration of Response Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the date of disease progression (PD) or death, only for those patients whose best overall response was complete response or partial response. PD: At least 20% increase in the sum of diameters of target lesions compared to Nadir (smallest sum of diameters on-study), unequivocal progression of existing non-target lesions, or presence of new lesion. For patients who were alive without progression, duration of response was censored on the date of the last evaluable tumor assessment.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Months||95% Confidence Interval|Median
1438180|NCT00949702|Secondary|Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants||95% Confidence Interval|Number
1438181|NCT00949702|Primary|Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)|BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Patients who never received study treatment and treated patients without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|From first treatment through September 27, 2010|Intent-to-treat population: All enrolled patients who received at least one, or a partial dose of vemurafenib.|||Percentage of participants||95% Confidence Interval|Number
1438182|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 43|Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.|Day 43.|Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.|||ng/mL.||Geometric Coefficient of Variation|Geometric Mean
1438183|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 29|Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.|Day 29.|Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.|||ng/mL.||Geometric Coefficient of Variation|Geometric Mean
1438184|NCT00949650|Secondary|Trough Plasma Concentrations of Afatinib at Day 22|Trough plasma concentrations of Afatinib at Day 22 (course 2, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.|Day 22.|Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.|||ng/mL.||Geometric Coefficient of Variation|Geometric Mean
1438185|NCT00949650|Secondary|HRQOL: Time to Deterioration in Pain|HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks).|RS.|||Months.||95% Confidence Interval|Median
1438186|NCT00949650|Secondary|HRQOL: Time to Deterioration in Dyspnoea|HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks).|RS.|||Months.||95% Confidence Interval|Median
1438187|NCT00949650|Secondary|Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing|HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.|Throughout the trial until progression (every 3 weeks).|RS.|||Months.||95% Confidence Interval|Median
1438188|NCT00949650|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|"ECOG PS measured on 6 point scale to assess participant’s performance status. 0=Fully active, able to carry on all pre-disease activities without restriction.~Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work.~Ambulatory (>50 percent of waking hours), capable of all self-care, unable to carry out any work activities.~Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours.~Completely disabled, cannot carry on any self-care, totally confined to bed or chair.~Dead."|Throughout the trial until progression (every 3 weeks), up to 28 months.|RS. Only patients with baseline and at least one post-baseline assessment were included.|||Participants|||Number
1438189|NCT00949650|Secondary|Change From Baseline in Body Weight|Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm.|Baseline and throughout the trial until progression (every 3 weeks), up to 28 months.|RS. Only patients with baseline and at least one post-baseline assessment were included.|||Kg.||Standard Deviation|Mean
1438190|NCT00949650|Secondary|Tumour Shrinkage|Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements.|||mm.||Standard Error|Mean
1438191|NCT00949650|Secondary|Overall Survival (OS) Time|OS was defined as time from randomisation to death.|From randomisation to cut-off date (17MAR2017).|RS.|||Months.||95% Confidence Interval|Median
1438192|NCT00949650|Secondary|Percentage of Participants With Disease Control (DC)|DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|RS.|||Percentage of participants with DC.||95% Confidence Interval|Number
1438193|NCT00949650|Secondary|Percentage of Patients With Objective Response (OR)|OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|RS.|||Percentage of patients with OR.||95% Confidence Interval|Number
1438194|NCT00949650|Primary|Progression-Free Survival (PFS) Time|PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression|Randomised set (RS)|||Months.||95% Confidence Interval|Median
1438195|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected|Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category.|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."|||participants|||Number
1438196|NCT00949533|Secondary|Number of Participants With Various Clinical Signs and Symptoms|"Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. Other in the category included abdominal pain, breathlessness, thoracic pain and tired."|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."|||participants|||Number
1438197|NCT00949533|Secondary|Percentage of Participants With A Reduction in Viral Load|Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load.|Baseline, Day 5|ITT population.|||percentage of participants|||Number
1438198|NCT00949533|Primary|Percentage of Participants Excreting Resistant Virus|Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).|Day 5|"ITT population. Here number of participants analyzed included evaluable participants for the outcome measure."|||percentage of participants|||Number
1438199|NCT00949234|Primary|Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit||24 Weeks|254 individuals were exposed to HIV once and received PEP; 11 individuals were exposed to HIV twice and received a PEP regimen twice; and 2 were exposed to HIV three times and received a PEP regimen for each of the three exposures|||HIV Exposure Events|HIV Exposure Events||Count of Units
1438200|NCT00949117|Secondary|Change in Weight for Age Z-score From Baseline Through 24 Weeks|Change in weight for age Z-score from Baseline through 24 weeks while on study treatment. Weight for age Z-score calculated using the Center for Disease Control and Prevention (CDC) weight-for-age Z score data tables.|Baseline and 24 weeks||||z score||Standard Deviation|Mean
1438201|NCT00949117|Secondary|Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24||24 weeks|Outcome not assessed as the one subject that completed the protocol was too young to complete the PedsFAACT quality of life assessment.||||||
1438202|NCT00949117|Secondary|Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition||24 weeks|Outcome not assessed as the one subject that completed the protocol did not have the prealbumin lab drawn at the 24 week visit and body composition tests assessed.||||||
1438203|NCT00949117|Secondary|Body Mass Index as Assessed at Baseline and 24 Weeks|Change in Body Mass Index (BMI) in subjects from Baseline visit to 24 week visit.|24 weeks||||kg/m^2||Standard Deviation|Mean
1438204|NCT00949117|Primary|Difference Between Measures of Weight at Baseline and at Week 24|Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.|24 weeks||||kilograms||Standard Deviation|Mean
1438205|NCT00949078|Primary|Omalizumab Received Before OFC 2|total mg|up to 6 months||||mg||Full Range|Median
1438206|NCT00949078|Primary|Omalizumab Received Before OFC 2|Number of doses|up to 6 months||||number of doses||Full Range|Median
1438207|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3|mg|up to 8 weeks||||mg||Full Range|Median
1438208|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2|mg|up to 8 weeks||||mg||Full Range|Median
1438209|NCT00949078|Primary|Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1|mg|up to 8 weeks||||mg||Full Range|Median
1438210|NCT00949078|Primary|Total Immunoglobulin E (IgE) After Pn-BHR Response|kU/L (range)|up to 6 months||||kU/L||Full Range|Median
1438211|NCT00949078|Primary|Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response|kU/L (range)|up to 6 months||||kU/L||Full Range|Median
1438212|NCT00949078|Primary|Percent Change in Peanut Specific Immunoglobulin E (IgE) From Baseline to After Pn-BHR Response|percentage|change from baseline to up to 6 months||||percentage change Peanut specific IgE||Full Range|Median
1438213|NCT00949078|Primary|Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8|Presence or absence of this change|up to 6 months||||Participants|||Count of Participants
1438214|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants|The primary outcome was the incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given. Treatments within 14 days of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 days after each treatment for malaria.|Randomization to 24 months of age||||Episodes per person year at risk|||Number
1438215|NCT00948896|Primary|Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants|The incidence of malaria, defined as the number of incident episodes per time at risk, during the period the intervention was given (6–24 mo of age). Treatments within 14d of a prior episode were not considered incident events. Time at risk was from the day following the initiation of study drugs to the last day of observation, minus 14 d after each treatment for malaria.|6 to 24 months of age||||Episode per person year at risk|||Number
1438216|NCT00948896|Secondary|Rebound Incidence of Malaria Defined as the Number of Treatments for New Episodes of Malaria Per Time at Risk||24 months to 36 months of age||||Incidence per person year at risk|||Number
1438217|NCT00948896|Secondary|Incidence of Any Adverse Events Defined as Severity Grade 3-4 That Are Possibly, Probably, or Definitely Related to Study Drugs|NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events published December, 2004|Time from randomization until 24 months of age||||incidence per person-year at risk|||Number
1438218|NCT00948857|Primary|Live Birth|Live Birth outcome compared between DHEA active treatment and Placebo|9 months|This study was closed for futility because of difficulty finding patients willing to undergo randomization.|||participants|||Number
1438219|NCT00948857|Secondary|Clinical Pregnancy||12 months|||||||
1438220|NCT00948857|Secondary|Androgen Side Effects||12 months|||||||
1438221|NCT00948857|Secondary|Endocrine Effects||12 months|||||||
1438222|NCT00948857|Primary|Live Birth||24 months|||||||
1438223|NCT00948818|Secondary|12-Week Percent of Abdominal Pain-free (APF) Days|"Abdominal pain free (APF) days are those days where the patient reported a score of ‘0’ for abdominal pain at its worst~Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Percent||Standard Deviation|Mean
1438224|NCT00948818|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline.~The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
1438225|NCT00948818|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
1438226|NCT00948818|Secondary|12-Week Change in Bloating|Bloating was assessed on an 11-point scale where a value of 0 is “none” and a value of 10 is “very severe”.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1438227|NCT00948818|Secondary|12-Week Change in Abdominal Discomfort|Abdominal Discomfort is measured on an 11-point scale where a value of 0 is “none” and a value of 10 is “very severe.”|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1438228|NCT00948818|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1438229|NCT00948818|Secondary|12-Week Severity of Straining|Straining is measured on a 5-point scale where a value of 1 is “not at all” and a value of 5 is “an extreme amount.|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1438311|NCT00947765|Primary|Pain(at 6 Months): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|6 months||||Units on a scale||Standard Deviation|Mean
1438230|NCT00948818|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|802 randomized patients received study drug. The 800 patients in the ITT population had at least 1 postrandomization entry of the primary efficacy assessment; 107 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1438231|NCT00948818|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency Rate|The number of Spontaneous Bowl Movements experienced per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||SBMs per week||Standard Error|Least Squares Mean
1438232|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.|"A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week.~The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
1438233|NCT00948818|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.~The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
1438234|NCT00948818|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Participant|||Number
1438235|NCT00948818|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||CSBMs per Week||Standard Error|Least Squares Mean
1438236|NCT00948818|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation."|Change from Baseline to Week 12|803 patients were randomized to treatment, and 802 patients received double-blind study drug. 800 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||Participants|||Number
1438237|NCT00948792|Primary|30 Minute-6 Hour Difference in Platelet Counts||30 minutes - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.|||Platelets (*10^3/mm^3)|Participants|Full Range|Median
1438238|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.|Baseline - 6 hours after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.|||Platelets (*10^3/mm^3)|Participants|Full Range|Median
1438239|NCT00948792|Primary|Change in Post-transfusion Platelet Counts|The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.|Baseline-30 minutes after transfusion|Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.|||Platelets (*10^3/mm^3)|Participants|Full Range|Median
1438501|NCT00946088|Secondary|Maternal Anticipated Adverse Medication Reaction||Up to the maternal discharge from delivery hospitalization||||Participants|||Count of Participants
1438240|NCT00948766|Secondary|Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician’s rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient’s treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient’s available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.|||Percentage of patients|||Number
1438241|NCT00948766|Secondary|Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1438242|NCT00948766|Secondary|Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the extension study|Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1438243|NCT00948766|Secondary|Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24|The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1438244|NCT00948766|Secondary|Core Study: Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24|The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician’s rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient’s treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient’s available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Percentage of patients|||Number
1438245|NCT00948766|Primary|Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24|The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1438341|NCT00947531|Secondary|ADAS-COG+ Response|A patient with an improvement from baseline of ≥ 4 points in the ADAS-COG+ score at a particular visit is considered to have an ADAS-COG+ response at that visit.|week 4, 12, 16, 24|||||||
1438502|NCT00946088|Secondary|Maternal Chorioamnionitis||Up to maternal hospital discharge||||Participants|||Count of Participants
1438246|NCT00948766|Primary|Core Study: Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24|"The ADCS-ADL-SIV is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a yes or no question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of yes reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement."|Baseline of the core study to Week 24 of the core study|Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1438247|NCT00948688|Secondary|Resectability Rate|Percentage of patients able to undergo surgical resection after protocol therapy.|5 months|One participant excluded from this analysis due to non-compliance with study drug administration.|||Participants|||Count of Participants
1438248|NCT00948688|Secondary|Response Rate|Participants who have either a complete response (disappearance of all target lesions), partial response (at least 30% decrease in sum of longest diameter of target lesions) or stable disease (decrease in size of less than 30% or increase in size of less than 20%).|1 year|One participant excluded from this analysis due to non-compliance with study drug administration.|||Participants|||Count of Participants
1438249|NCT00948688|Secondary|Overall Survival|Percentage of participants still alive at 1 year after enrollment on study|1 year|One participant excluded from this analysis due to non-compliance with study drug administration.|||Participants|||Count of Participants
1438250|NCT00948688|Secondary|Number of Participants Experiencing Unacceptable Toxicity|All participants who receive at least one dose of study treatment were evaluable for toxicity. Unacceptable toxicity is based on the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Most grade 3 (severe) or 4 (life-threatening) events are considered to be unacceptable toxicities -- exceptions include nausea or vomiting, fatigue, and alopecia. Hematologic toxicities need to be either grade 4 or last for protocol-defined durations to be considered unacceptable.|1 year||||Participants|||Count of Participants
1438251|NCT00948688|Secondary|Progression Free Survival|Progression free survival for this endpoint was defined as the duration of time from beginning of the patients' initial chemotherapy to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.|2 years||||months||95% Confidence Interval|Median
1438252|NCT00948688|Primary|Progression Free Survival (PFS) at 7 Months From Registration|Progression free survival was defined as the duration of time from registration on study to time of objective disease progression. Death was regarded as a progression event. Progression was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions as seen on radiologic evaluation.|7 months||||months||95% Confidence Interval|Median
1438253|NCT00948688|Primary|Maximally Tolerated Dose (MTD) of Vorinostat in Combination With Infusional 5-FU and Radiation Therapy.|The maximum tolerated dose (MTD) is defined as one dose level below the dose level at which participants experience an unacceptable rate of dose-limiting toxicity.|6 weeks||||milligrams per day|||Number
1438254|NCT00948675|Secondary|Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD)|Disease control rate is the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1438255|NCT00948675|Secondary|Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate)|Overall Response rate (ORR) is the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is the disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|Baseline to date of objective progressive disease up to 39.49 months|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1438256|NCT00948675|Secondary|Overall Survival (OS)|OS is defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.|Randomization to date of death from any cause up to 39.49 months|All randomized participants. The number of participants censored was 52 for pemetrexed + carboplatin group and 56 for paclitaxel + carboplatin + bevacizumab group.|||months||90% Confidence Interval|Median
1438312|NCT00947765|Primary|Pain(at 12 Weeks): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|12 weeks||||Units on a scale||Standard Deviation|Mean
1438257|NCT00948675|Secondary|Progression Free Survival (PFS)|PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease up to 39.49 months|All randomized participants. The number of participants censored was 35 for pemetrexed + carboplatin group and 49 for paclitaxel + carboplatin + bevacizumab group.|||months||90% Confidence Interval|Median
1438258|NCT00948675|Primary|Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.|Randomization to measured progressive disease or treatment discontinuation up to 39.49 months|All randomized participants. The number of participants censored was 30 for pemetrexed + carboplatin group and 35 for paclitaxel + carboplatin + bevacizumab group.|||months||90% Confidence Interval|Median
1438259|NCT00948610|Secondary|Cellular Inflammation|Percentage of monocytes producing interleukin-6 at post-infusion day 2 in placebo vs. remicade|Post-infusion day 2||||percentage of monocytes||Standard Deviation|Mean
1438260|NCT00948610|Primary|Slow Wave Sleep|Slow wave sleep in minutes at post-infusion day 2 in placebo vs. remicade|Post-infusion day 2||||Minutes||Standard Deviation|Mean
1438261|NCT00948506|Secondary|Subject-reported Adverse Events or Abnormal Findings|Number of participants who reported an adverse event (as assessed by subject interview and if indicated, physical exam) or had abnormal finding on urine and blood laboratory examination|up to 16 weeks|The analysis was performed using intention-to-treat, whereby all enrolled participants who received treatment were analyzed.|||participants|||Number
1438262|NCT00948506|Primary|Physician's Global Assessment (PGA) of Hair Density|Number of participants with a score of 2 or less on the Physician Global Assessment (PGA) of Hair Density at the end of active treatment. The five point scale ranges from 0 (total alopecia) to 5 (very dense).|up to 8 weeks or end of active treatment|The analysis was performed using intention-to-treat and all enrolled participants who received treatment were included in the analysis. For participants who withdrew during treatment, the data from their last visit were carried forward.|||participants|||Number
1438263|NCT00948441|Secondary|Safety, Side Effects|collection of adverse events and safety information. Each participant was contacted either at a clinical visit or by phone every two weeks while enrolled in the study.|7 months per study patient|collected adverse events during each time period|||participants|||Number
1438264|NCT00948441|Primary|Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period.|For the purpose of this study, episodes of catheter related blood stream infections were considered as the primary outcome measure. An episode of infection was defined as more than one positive blood culture obtained from the catheter requiring antibiotic therapy. Each episode after enrollment was recorded in its appropriate study period: ethanol lock, placebo lock, or washout period. If a patient had a catheter related blood stream infections, the study locks were held until after the number of days in each period was calculated as the number of days not on antibiotic therapy.|7 months per study patient|This was a crossover study. Each participant served as their own control. Infections in each time period of the study were compared. Infections with using ethanol locks and infections while using heparin locks.|||number of CRBSI per 1000 catheter days|||Number
1438265|NCT00948389|Other Pre-specified|Number of Participants With Disease Progression at 12 Months|As measured by brain magnetic resonance imaging.|12 months|Treated participants|||participants|||Number
1438266|NCT00948389|Primary|Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria|Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants|||participants|||Number
1438267|NCT00948389|Primary|Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria|Neutrophils (neutropenia): Grade (gr)1 <LLN–1500/mm3; Gr2 <1500–1000/mm3; Gr3 <1000–500/mm3; Gr4 <500/mm3. Leukocytes (leukopenia): Gr1 <LLN–3000/mm3; Gr2 <3000–2000/mm3; Gr3 <2000–1000/mm3; Gr4 <1000/mm3. Lymphocytes (lymphocytopenia): Gr1 <LLN–800/mm3; Gr2 <800–500/mm3; Gr3 <500–200/mm3; Gr4 <200/mm3. Platelets (thrombocytopenia): Gr1 <LLN–75,000/mm3; Gr2 <75,000–50,000/mm3; Gr3 <50,000–25,000/mm3; Gr4 <25,000/mm3. Hemoglobin (anemia): Gr1 <LLN–10.0 g/dL; Gr2 <10.0–8.0 g/dL; Gr3 <8.0–6.5 g/dL; Gr4 <6.5 g/dL. LLN/ULN=lower/upper limit of normal (normal ranges may vary by local laboratories).|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|Treated participants|||participants|||Number
1438268|NCT00948389|Primary|Deaths Within 30 Days of Protocol Treatment Discontinuation||From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0).|Treated participants|||participants|||Number
1438342|NCT00947531|Secondary|Change From Baseline in ADAS-COG+ (Alzheimer’s Disease Assessment Scale Cognitive Subpart)|The modified Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-COG+) is a psychometric instrument used by a neuropsychologist that evaluates memory, attention, reasoning, language, orientation and praxis.|week 4, 12, 16|||||||
1438269|NCT00948389|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts <0.5x10^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count <1x10^9/L and fever of >=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents.|The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1.|Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation.|||participants|||Number
1438270|NCT00948389|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs|SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening.|Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0).|All treated participants|||participants|||Number
1438271|NCT00948298|Secondary|Changes in Sitting and 24 Ambulatory Blood Pressure|Improved vascular function as determined by measuring sitting and 24 Hour Ambulatory Blood Pressure.|12 weeks||||mmHg||Standard Deviation|Mean
1438272|NCT00948298|Primary|Pulse Wave Velocity for Vascular Stiffness|The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device.|12 Weeks||||m/s||Standard Deviation|Mean
1438273|NCT00948246|Secondary|Change in Weight|Change in weight (in kilograms) at baseline to 12 months|12 months||||pounds||95% Confidence Interval|Mean
1438274|NCT00948246|Secondary|Change in BMI|Decrease in body mass index (BMI; measured in kg/m2) from baseline to 12 months|12 months||||kg/m2||95% Confidence Interval|Mean
1438275|NCT00948246|Secondary|% Excess Weight Loss|Percent excess weight loss was defined as weight loss divided by excess weight multiplied by 100, where weight loss was equal to baseline weight minus follow-up weight, and excess weight was equal to baseline weight minus ideal weight.|12 months||||percentage of excess weight loss||95% Confidence Interval|Mean
1438276|NCT00948246|Primary|Feasibility and Ease of Implantation|"Percent of subjects whose device implantation was rated by the surgeon as a 1 or 2 on a 5-point scale, where 1 is very easy and 5 is impossible."|< 1day|Intent-to-treat|||percentage of subjects|||Number
1438277|NCT00948155|Secondary|Subjective Measures to Assess Smoking Urges|Craving for cigarettes was assessed with the 32-item Questionnaire of Smoking Urges (QSU) during each study visit. In order to calculate the QSU measure, each item is rated on a Likert-type scale from 1 (strongly disagree) to 7 (strongly agree). The values are then summed to create a single total score. Well validated 2 factor subscale scores were also created by summing the item scores for the 2 factors: Factor 1 reflects the desire to smoke for pleasure and Factor 2 reflects urges to smoke to relieve withdrawal-related negative affect. Internal consistency for each scale across all time points was high (Cronbach’s α > 0.95, 0.85, and 0.95 for Factor 1, Factor 2, and QSU total, respectively). Scale range is 1-7 where 1 is low urge to smoke and 7 represents high urge to smoke. Data was collected at each time point but outcome measure of interest is end of period.|Days 21 of each of the two 21-day study periods, range 1(low)-7(high)|Subjects who completed both 21 day placebo and drug periods.|||units on a scale||Standard Deviation|Mean
1438278|NCT00948155|Secondary|Carbon Monoxide Levels|Exhaled breath carbon monoxide levels collected at Day 1 and Day 21 sessions. Alveolar carbon monoxide is a validated assessment of smoke exposure.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||parts per million||Standard Error|Mean
1438279|NCT00948155|Secondary|Cotinine Levels From Urine Samples|Cotinine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||micromolar||Standard Deviation|Mean
1438280|NCT00948155|Secondary|Nicotine Levels From Urine Samples|Nicotine levels from urine samples collected at Day 1 and Day 21.|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||micromolar||Standard Deviation|Mean
1438281|NCT00948155|Secondary|Total Nicotine Metabolites From Urine Samples|Total urinary metabolites from urine samples collected at Day 1 and Day 21|Samples from Day 1 and Day 21 of two 21 day Periods|Subjects who completed both 21 day placebo and drug periods.|||micromolar||Standard Deviation|Mean
1438282|NCT00948155|Primary|Daily Cigarette Consumption|Average of the number of cigarettes smoked per day|Two 21 day study periods||||number of cigarettes smoked per day||Standard Error|Mean
1438283|NCT00948155|Primary|The Number of Choices of a Nicotine Containing Cigarette Compared to a Non-nicotine Cigarette.|Participants were given 4 puff choices (between a nicotine containing and de-nicotinized cigarette) on 6 study visits, for a total of 24 choices. Number of puffs reported is average across both study periods.|Days 1, 7, 21 of each of two 21 day study periods|All participants who completed the task were included in the analysis|||number of puffs chosen of a maximum 24||Standard Error|Mean
1438314|NCT00947765|Primary|Pain(at 4 Weeks): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|4 weeks||||Units on a scale||Standard Deviation|Mean
1438284|NCT00948155|Primary|Smoking Topography: Total Puff Volume|Total puff volume was created by summing all of the puffs from the cigarette smoked in the lab at each time point (each lab visit). This value represents the total volume of smoke extracted from a single cigarette and it a standard measure of smoking behavior. A total puff volume represents the total smoking volume from a cigarette. Values are reported in milliliters. Value of interest is the average puff volume across all sessions for all participants in a group and is reported as a key measure of smoking behavior. Analyses were repeated measures analysis of variance where individual, time and drug were within factors.|Days 1-21 of each of 2 study periods|All those participants who completed both study periods were included in the analysis.|||milliliters||Standard Error|Mean
1438285|NCT00948090|Secondary|Overall Response Rate|The overall response status is complete response and not complete response (partial remission, primary refractory/primary induction failure, stable disease, progressive disease, and relapse) at Baseline and each of the scheduled follow-up time points.|Baseline, Day 100, Month 6, 12, 24, Early termination and End of Trial (within 30 days of the trial termination)|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Participants|||Number
1438286|NCT00948090|Secondary|Number of Transplant-related Death Events Until Day 100.|Transplant-related mortality was defined as death due to any cause other than disease relapse/progression up until Day 100.|Day 100|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Transplant-related death|||Number
1438287|NCT00948090|Secondary|Number of Death Events in 2 Years.|The time of overall survival was defined as the time from transplantation to death of all causes.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the ITT data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Deaths|||Number
1438288|NCT00948090|Primary|Number of Progression Events in 2 Years.|The time of Progression-Free Survival (PFS) was defined as the time from transplantation to the occurrence of the event that was death or first recurrence of progressive disease.|2 years|Participants receiving at least 1 PK-directed IV busulfan dose followed by autologous hematopoietic stem cell transplant are included in the Intent-to-treat (ITT) data set. Four participants (of 207) did not continue to the conditioning regimen after receiving the PK test dose and were excluded from ITT data set.|||Event|||Number
1438289|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase II, Baseline to 60 days following first treatment.|Of the 79 participants enrolled, 78 were evaluable and 1 participant withdrew from study.|||participants|||Number
1438290|NCT00948064|Primary|Response Rate|Number of participants with Complete Response (CR) in AML requiring disappearance of all signs and symptoms related to disease, normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a marrow with 5% or less marrow blasts; a hematologic improvement (HI) defined as a CR except for a platelet count increase by 50% to above 30 x 10^9/L. For MDS, the International Working Group criteria used to assess response.|12-18 Months|Out of 79 participants enrolled in Phase II, 2 participants were not evaluable - 1 participant was removed from study per treating physician discretion and the other was removed per participant's request.|||participants|||Number
1438291|NCT00948064|Primary|Survival at Day 60|Assessment of survival for outcome done on 60 days following therapy and includes participants alive for at least 60 days. Survival is calculated from start of therapy until death from any cause.|Phase I, Baseline to 60 days following first treatment.|Of the 31 enrolled participants, 30 were evaluable and 1 participant never received treatment.|||participants|||Number
1438292|NCT00947882|Secondary|Mean Change in Maximum Urinary Flow (Qmax)|Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
1438293|NCT00947882|Secondary|Mean Percentage Change in Total Prostate Volume (TPV)|TPV was measured directly by standardised trans-rectal ultrasound (TRUS).|From Baseline to Month 3 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
1438294|NCT00947882|Secondary|Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS|A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.|At Month 3, Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage of participants|||Number
1438295|NCT00947882|Secondary|Mean Change in IPSS|This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.|From Baseline to Month 4, Month 5 and Month 6 after Dosing|"FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
1438313|NCT00947765|Primary|Pain(at 12 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|12 weeks||||Units on a scale||Standard Deviation|Mean
1438296|NCT00947882|Primary|Mean Change in International Prostate Symptom Score (IPSS)|"This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days.~The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score."|From Baseline to Month 3 after Dosing|"FAS. The as planned patient allocation for treatment groups was used in the efficacy analyses (please refer to the Baseline Characteristics section)."|||percentage change from baseline||Standard Deviation|Mean
1438297|NCT00947856|Secondary|Incidence of Antitherapeutic Antibodies|Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment|Up to 39 months|Any patient who received extension treatment or retreatment and had baseline and postbaseline sample results; 1 HL patient on the retreatment arm did not have postbaseline sample results and 3 ALCL patients on the retreatment arm were retreated more than once and had samples.|||participants or experiences|Retreatment or Extension Txt Experiences||Number
1438298|NCT00947856|Secondary|Overall Survival|Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause|Up to approximately 41 months|Patients who received treatment on the extension arm, and patients who received retreatment and had postbaseline response results; 1 HL patient on the retreatment arm did not have postbaseline response results and 3 ALCL patients on the retreatment arm were retreated more than once.|||months|Retreatment or Extension Trt Experiences|95% Confidence Interval|Median
1438299|NCT00947856|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause|Up to approximately 29 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.|||months|Retreatment Experiences|95% Confidence Interval|Median
1438300|NCT00947856|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death|Up to 38 months|Participants with objective response among those who received retreatment|||months|Retreatment Experiences|95% Confidence Interval|Median
1438301|NCT00947856|Primary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|Up to 39 months|All participants who received treatment|||participants|||Number
1438302|NCT00947856|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 39 months|All participants who received treatment|||participants|||Number
1438303|NCT00947856|Primary|Objective Response Rate by Investigator|Percentage of participants in the retreatment arm who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 38 months|Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.|||percentage of retreatment experiences|Retreatment Experiences|95% Confidence Interval|Number
1438304|NCT00947791|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
1438305|NCT00947791|Secondary|Clinician-Administered Dissociative States Scale (CADSS)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
1438306|NCT00947791|Secondary|Brief Psychiatric Rating Scale (BPRS)||4 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
1438307|NCT00947791|Secondary|Young Mania Rating Scale (YMRS)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
1438308|NCT00947791|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
1438309|NCT00947791|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)||24 hrs post-infusion compared to baseline|Based on confidentiality concerns, 0 participants analyzed.||||||
1438310|NCT00947765|Primary|Pain(at 6 Months): Nirschl Staging|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|6 months||||Units on a scale||Standard Deviation|Mean
1438330|NCT00947544|Secondary|Number and Causes of Hyperammonemic Events (Safety Extension)|"Number of Subjects with at Least One Hyperammonemic Crisis.~Hyperammonemic crisis is defined as follows:~• Clinical symptoms associated with ammonia of ≥ 100 µmol/L"|1 year||||participants|||Number
1438315|NCT00947765|Primary|Pain(at 4 Weeks): Visual Analogue Scale|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever."|4 weeks||||Units on a scale||Standard Deviation|Mean
1438316|NCT00947765|Primary|Pain(at 1 Week): Nirschl Staging (0 to 7)|"NIRSCHL STAGING:~phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps~No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain"|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.|||Units on a scale||Standard Deviation|Mean
1438317|NCT00947765|Primary|Pain (at 1 Week): Visual Analogue Scale(0 to 10)|"VISUAL ANALOGUE SCALE:~Pain of the participants will be assessed by most widely used and accepted “visual analogue scale”. It consists of a 10 centimeter line marked at one end with “no pain” and at other end with “worst pain ever”. Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between “no pain” to patients mark.~No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever."|1 week|Participants were clinically examined for the treatment response i.e., decrease in pain.|||Units on a scale||Standard Deviation|Mean
1438318|NCT00947752|Secondary|Degree of Pain Within 5 Mins After Injection|A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.|||Scores on a scale||Standard Deviation|Mean
1438319|NCT00947752|Primary|Subject-reported Pain Associated Immediately After Each Injection|A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent “no pain” and up to 100 mm to represent “worst possible pain;” subjects drew a continuous line to represent their level of pain.|5 weeks of injections|Of the 147 subjects to be analyzed, 3 were excluded for discontinuations due to withdraw of consent.|||Scores on a scale||Standard Deviation|Mean
1438320|NCT00947661|Primary|Change in Intraocular Pressure From Baseline to Week 12|95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)|12 weeks|Intent to treat population without LOCF|||mm Hg||Standard Error|Least Squares Mean
1438321|NCT00947544|Secondary|Quality of Life Assessed by the SF-15 Questionnaire|"change from baseline to Month 12.~The SF 15 questionnaire consists of 15 questions that assess the following:~Physical functioning (5 questions)~Emotional functioning (4 questions)~Social functioning (3 questions)~School functioning (3 questions) Items were scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or a 3-point scale (0 [not at all], 2 [sometimes], or 4 [a lot] for the young child self-report). Items were reverse-scored and linearly transformed to a 0–100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score was 0-100 scale (averaged from each functional areas). In the 0-100 scale, 0 is the worst score and 100 is best score.~Improved quality of life was shown by increased total score from baseline to Month 12."|1 year|Patients who completed SF-15 at baseline and Month 12 both time in the safety extension period.|||score on a scale|total score from SF-15 report|Standard Deviation|Mean
1438322|NCT00947544|Secondary|Plasma PAGN AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||μg*h/mL AUC 0-24||Standard Deviation|Mean
1438323|NCT00947544|Secondary|Plasma PBA (Phenylbutyrate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||µg*h/ml AUC 0-24||Standard Deviation|Mean
1438324|NCT00947544|Secondary|Plasma PAA (Phenylacetate) AUC0-24 Values on NaPBA vs. HPN-100 on on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||μg•h/mL AUC 0-24||Standard Deviation|Mean
1438325|NCT00947544|Secondary|Urinary PAGN 24-hour Excretion Values on NaPBA vs. HPN-100 (Switch Over)|Urinary PAGN (phenylacetylglutamine) 24-hour excretion. Urine was collect during 0-12 hrs and 12-24 hrs.|Day 7 (NaPBA) and Day 14 (HPN-100)||||μg||Standard Deviation|Mean
1438326|NCT00947544|Secondary|Rate (Percentage) of Ammonia Values Above Upper Limit of Normal (ULN) on NaPBA vs. HPN-100|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||percentage of sample|number of blood sample||Number
1438327|NCT00947544|Secondary|Average Ammonia Values on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug (Switch Over)|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||µmol/L||Standard Deviation|Mean
1438328|NCT00947544|Secondary|NH3 Cmax on NaPBA vs. HPN-100 on the Last Day of Treatment With Each Drug|blood samples were collected at pre-dose, 4, 8, 12, 16, 20, and 24 hour post dose on both Day 7 (NaPBA) and Day 14 (HPN-100).|Day 7 (NaPBA) and Day 14 (HPN-100)||||μmol/L||Standard Deviation|Mean
1438329|NCT00947544|Secondary|Blood Ammonia Control|To evaluate control of blood ammonia by HPN-100 compared with NaPBA in pediatric patients with UCDs.|Day 7 (NaPBA) and Day 14 (HPN-100)||||μmol∙h/L||Standard Deviation|Mean
1438345|NCT00947531|Primary|Change From Baseline in ADAS-cog+ (Alzheimer's Disease Assesment Scale - Cognitive Subpart) at Week 24|The ADAS-COG+ is a psychometric instrument used to evaluate memory, attention, reasoning, language, orientation and praxis. The score ranges from 0 to 85 with 85 being the worst score. A negative change indicates cognitive improvement.|baseline and week 24|The primary and confirmatory analysis is based on the ITT analysis set. The LOCF method is applied to account for missing data. The ITT analysis set consists of all randomized patients, who received at least one dose of study medication and had a baseline and at least one post-baseline assessment for both primary efficacy measures.|||points on a scale||Standard Deviation|Mean
1438346|NCT00947518|Secondary|Incidence of Clinical and Culture Positive Sepsis|Infants with symptoms and/or signs suggestive of sepsis and a positive blood culture (with known pathogens and coagulase negative staphylococcus) were diagnosed to have culture positive sepsis; Those with negative cultures but with positive sepsis screen were classified as having clinical sepsis|First week of life||||Participants|||Count of Participants
1438347|NCT00947518|Primary|Number of Participants With Positive Skin Culture at Axilla|Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention|24 hours after intervention||||participants|||Number
1438348|NCT00947518|Primary|Skin Temperature at 30 Min After Intervention|Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes|at 30 min after intervention||||Degree Celsius||Standard Deviation|Mean
1438349|NCT00947518|Primary|Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al|The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)|At 24 hours||||score on a scale||Full Range|Median
1438350|NCT00947505|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline|Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region|16 and 26 weeks||||change in terminal hair count||Standard Deviation|Mean
1438351|NCT00947427|Primary|C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|12 months||||nmol/L||95% Confidence Interval|Geometric Mean
1438352|NCT00947349|Secondary|CL/F,ss for BI 201335 ZW|apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1438353|NCT00947349|Secondary|Cavg for RBV|average plasma concentration (Cavg) of RBV|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438354|NCT00947349|Secondary|Cavg for BI 201335 ZW|average plasma concentration (Cavg) of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438355|NCT00947349|Secondary|Cmin,ss for RBV|Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438356|NCT00947349|Secondary|Cmin,ss for BI 201335 ZW|Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438357|NCT00947349|Secondary|t1/2,ss for BI 201335 ZW|terminal half-life of the analyte in plasma at steady state (t1/2,ss)|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||hour(s)||Geometric Coefficient of Variation|Geometric Mean
1438358|NCT00947349|Secondary|Tmax, ss for RBV|Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||hour(s)||Full Range|Median
1438359|NCT00947349|Secondary|Tmax, ss for BI 201335 ZW|Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|PKS|||hour(s)||Full Range|Median
1438360|NCT00947349|Secondary|Tmax for RBV|Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS|||hour(s)||Full Range|Median
1438361|NCT00947349|Secondary|Tmax for BI 201335 ZW|Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|PKS|||hour(s)||Full Range|Median
1438362|NCT00947349|Secondary|Cmax,ss of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438380|NCT00947349|Secondary|Rapid Virological Response (RVR)|Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438363|NCT00947349|Secondary|AUCτ,ss of RBV|Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1438364|NCT00947349|Secondary|Cmax of RBV|Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438365|NCT00947349|Primary|Assessment of Tolerability in Triple Combination Therapy|An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.|||participants|||Number
1438366|NCT00947349|Secondary|AUCτ,1 for Ribavirin (RBV)|Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a|-0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1438367|NCT00947349|Secondary|Cmax,ss of BI 201335 ZW|Maximum concentration of BI 201335 ZW at steady state|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438368|NCT00947349|Secondary|AUCτ,ss of BI 201335 ZW|AUC at steady state after 4 weeks combination of the last dose|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1438369|NCT00947349|Secondary|Cmax of BI 201335 ZW|Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1438370|NCT00947349|Secondary|AUCτ,1 for BI 201335 ZW|Area under the curve (AUC) concentration after the first dose of BI 201335 ZW|10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose|The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1438371|NCT00947349|Secondary|Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV|An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.|44 weeks|TS|||participant(s)|||Number
1438372|NCT00947349|Secondary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.|44 weeks|TS|||participant(s)|||Number
1438373|NCT00947349|Secondary|Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV|Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|44 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.|||participant(s)|||Number
1438374|NCT00947349|Secondary|Sustained Virologic Response (SVR)|Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion|72 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438375|NCT00947349|Secondary|End of Treatment Response (ETR)|Number of patients with plasma HCV RNA level BLD at week 48|48 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438376|NCT00947349|Secondary|Complete Early Virological Response (cEVR)|Number of patients with plasma HCV RNA level BLD at Week 12|12 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438377|NCT00947349|Secondary|Early Virological Response (EVR)|Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12|12 Weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438378|NCT00947349|Secondary|Day 28 Virologic Response|Number of patients with HCV viral load reduction >= 2 log10 at Week 4|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438379|NCT00947349|Secondary|Change From Baseline in HCV Viral Load|Change form baseline in HCV viral load (log10) after 4 weeks|baseline and week 4|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||IU/mL||Standard Error|Mean
1438403|NCT00947154|Secondary|CGI-I Score of 1 or 2 (Very Much or Much Improved)|CGI = Clinical Global Improvement 7-item scale, from very much worse to very much better.|At week 8|11 of the 12 subjects initially enrolled. One subject was lost to follow-up after the baseline visit.|||participants|||Number
1438381|NCT00947349|Secondary|Week 4 Virological Response (W4VR)|Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))|4 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438382|NCT00947349|Secondary|Week 2 Virological Response (W2VR)|Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))|2 weeks|The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.|||participants|||Number
1438383|NCT00947349|Primary|Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy|Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.|||participants|||Number
1438384|NCT00947349|Primary|Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|4 weeks|The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation.|||participants|||Number
1438385|NCT00947310|Primary|Inappropriate ICD Therapy|First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)|Average of 1.4 years follow-up||||participants|||Number
1438386|NCT00947310|Secondary|Syncope|First episode of syncope|Average of 1.4 years follow-up||||participants|||Number
1438387|NCT00947310|Secondary|All-cause Mortality||Average 1.4 years of follow-up||||participants|||Number
1438388|NCT00947297|Secondary|Patient Satisfaction With HPN-100|Drug preference will be noted at week 3|Month 1 post dose|all available questionnaires|||% preferred HPN-100|||Number
1438389|NCT00947297|Secondary|Blood Ammonia Levels|Venous Ammonia levels over time|1 Year||||Umol/L||Standard Deviation|Mean
1438390|NCT00947297|Secondary|Number and Causes of Hyperammonemic Events|Number of hyperammonemic crises per patient|1 year||||hyperammonemic events||Standard Deviation|Mean
1438391|NCT00947297|Primary|Rate of Adverse Events (Number of Participants Who Experienced Any AE Considered Related to Study Drug)||1 year||||participants|||Number
1438392|NCT00947284|Primary|Change in Skin Sensitivity as Measured by a Visual Analog Scale|Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).|Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration|The planned model of skin irritation could not be reproduced on 3 enrolled participants, thus the investigator did not obtain outcome data.||||||
1438393|NCT00947271|Primary|Number of Sexual Partners, 12 Months Post Intervention|number of sexual partners in the past 3 months, assessed 12 months post intervention|12 months post intervention||||number of partners||Standard Error|Least Squares Mean
1438394|NCT00947271|Primary|Number of Sexual Partners, 9 Months Post Intervention|number of sexual partners in the past 3 months, assessed 9 months post intervention|9 months post intervention||||number of partners||Standard Error|Least Squares Mean
1438395|NCT00947271|Primary|Number of Sexual Partners, 6 Months Post Intervention|number of sexual partners reported in the past 3 months, assessed 6 months post intervention.|6 months post intervention||||number of partners||Standard Error|Least Squares Mean
1438396|NCT00947271|Secondary|Sexually Transmitted Infection Incidence|number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up|Measured throughout the 12 months post intervention|Participants who provided a urine sample for STI testing at any study follow up (3, 6, 9, or 12 months) OR who had STI testing performed at the STI clinic during the 12 months post intervention were included in these analyses|||participants diagnosed with any STI|||Number
1438397|NCT00947271|Primary|Number of Sexual Partners, 3 Months Post Intervention|number of sexual partners in the past 3 months, assessed 3 months post intervention|Measured after 3 months||||number of partners||Standard Error|Least Squares Mean
1438398|NCT00947219|Primary|Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia|The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.|baseline, 16 and 26 weeks||||hairs per cm^2|Participants|Standard Deviation|Mean
1438399|NCT00947167|Secondary|Toxicities Assessed by CTCAE Grading Criteria and Assigned Attributions Accordingly|by CTCAE|AEs are assessed every cycle (every 3 wks)|whole cohort|||Participants|||Count of Participants
1438400|NCT00947167|Primary|Response Rate (RR) for All Patients Treated With This Strategy (Simon Design)|RECIST v1.1 used|CT scans are done every 4 cycles (every 12 wks)|whole cohort|||Participants|||Count of Participants
1438401|NCT00947154|Secondary|Clinical Global Impressions Improvement (CGI-I)|The CGI-I is a clinician rated scale ranging from 0 (not assessed) to 7 (very much worse), with intermediate scores of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse). The clinician is rating the overall change in the patient's clinical condition.|At week 8|11 participants. 1 participant lost to follow up after week 1|||percentage completers with score 1 or 2|||Number
1438402|NCT00947154|Primary|Mass General Hair Pulling Scale, Actual Pulling Subscale|Sum of scores for items 4, 5 and 6 from the Mass General Hair Pulling Scale (Frequency of Pulling, Attempts to Resist Pulling, Control Over Hair Pulling). Score can range from 0 to 12; higher scores indicate more severe hair pulling.|change from baseline to end of week 8|11 participants. 1 participant was lost to follow-up after week 1.|||units on a scale||Standard Deviation|Mean
1438404|NCT00947154|Primary|Mass General Hair Pulling Scale|A brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess frequency and intensity of urges to pull, ability to control the urges, frequency of pulling, attempts to resist pulling, success in resisting, and associated distress. Statistical analyses indicate that the seven items form a homogenous scale for the measurement of severity in trichotillomania. Higher scores indicate greater severity of hair pulling. Total score can range from 0 to 28.|Change from baseline to week 8|11 of the 12 subjects initially enrolled. One was lost to follow-up after baseline visit.|||units on a scale||Standard Deviation|Mean
1438405|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Year 0 up to Year 10|The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available throughout the study.|||Subjects|||Number
1438406|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 (Year 9) to the Month 120 (Year 10) visit|The analysis was based on the Total Vaccinated cohort at Year 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 10.|||Subjects|||Number
1438407|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 (Year 8) to the Month 108 (Year 9) visit|The analysis was based on the Total Vaccinated cohort at Year 9, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 9.|||Subjects|||Number
1438408|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 (Year 7) to the Month 96 (Year 8) visit|The analysis was based on the Total Vaccinated cohort at Year 8, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 8.|||Subjects|||Number
1438409|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 (Year 6) visit to Month 84 (Year 7) visit|The analysis was based on the Total Vaccinated cohort at Year 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 7.|||Subjects|||Number
1438410|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the Month 60 (Year 5) visit until the Month 72 (Year 6) visit|The analysis was based on the Total Vaccinated cohort at Year 6, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 6.|||Subjects|||Number
1438411|NCT00947115|Secondary|Number of Subjects With Any Fatal or Vaccine-related Serious Adverse Events (SAEs) (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 in primary study (NCT00196937) up to Month 60 (Year 5)|The analysis was based on the Total Vaccinated cohort at Year 5, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study [NCT00196937]) for whom data were available at Year 5.|||Subjects|||Number
1438412|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.|||µg/mL||95% Confidence Interval|Geometric Mean
1438413|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the Total Vaccinated Cohort at Years 5, 6 and 7, which included all vaccinated subjects (i.e. all subjects who received 3 doses of HPV vaccine in the primary study NCT00196937) for whom data were available at the concerned year.|||µg/mL||95% Confidence Interval|Geometric Mean
1438414|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL)|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||µg/mL||95% Confidence Interval|Geometric Mean
1438415|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS|Titers were given as GMTs expressed in microgram per milliliter (µg/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||µg/mL||95% Confidence Interval|Geometric Mean
1438416|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Years 7, 8, 9, 10|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1438417|NCT00947115|Secondary|Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS)|Anti-HPV-16/18 titers in CVS were given as GMTs expressed in ELISA units per milliliter (EL.U/mL).|At Year 5 and Year 6|Analysis was performed on the subset of subjects from the Total Vaccinated Cohort who volunteered for CVS sample collection at Year 5 and Year 6 and for whom their CVS sample contained less than 200 erythrocytes per microliter.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1438418|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1438419|NCT00947115|Secondary|Total Immunoglobulin G (IgG) Antibody Titers in Serum|IgG antibody titers were expressed as GMTs in microgram per milliliter (µg/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1438420|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.|||Subjects|||Number
1438421|NCT00947115|Primary|Number of Seroconverted Subjects.|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 8 and 7 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.|||Subjects|||Number
1438422|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers respectively greater than or equal to 19 and 18 EL.U/mL) in the serum of subjects seronegative before vaccination in the primary study.|At Years 8, 9 and 10|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.|||EU/mL||95% Confidence Interval|Geometric Mean
1438423|NCT00947115|Primary|Anti-Human Papillomavirus (Anti-HPV) 16/18 Antibody Titers in Serum|Titers were expressed as Geometric Mean Titer (GMT) in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).|At Year 5, 6 and 7|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects that were included in the ATP cohort for immunogenicity of the primary study (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1438424|NCT00947011|Secondary|Peripheral Glucose Utilization and Peripheral Glucagon Release||one year|Data was not collected for this outcome measure. The study was terminated. The P.I. left the institution.||||||
1438425|NCT00947011|Primary|Insulin Release Rate and Hepatic Glucose Release||One year|Data was not collected for this outcome measure. The study was terminated. The P.I. left the institution.||||||
1438426|NCT00946998|Secondary|Serious Adverse Events During the 12 Week Study Duration.|death, dialysis initiation, hospitalizations, or bleeding requiring transfusion|during 12 week study duration||||Participants|||Count of Participants
1438427|NCT00946998|Secondary|Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health.|Raw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life.|baseline to 12 weeks||||units on a scale||Inter-Quartile Range|Median
1438428|NCT00946998|Secondary|Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale|Each item is rated on a 0 to 8 Likert scale with 0 indicating no impairment and 8 indicating severe impairment and a total score range of 0 to 40.|baseline to 12 weeks||||units on a scale||95% Confidence Interval|Mean
1438429|NCT00946998|Secondary|Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5|The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.|baseline to 12 weeks||||participants|||Number
1438430|NCT00946998|Primary|Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.|The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.|baseline to 12 weeks||||units on a scale||95% Confidence Interval|Mean
1438431|NCT00946985|Primary|Time to Relapse During Relapse Prevention Phase|Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.|24 months|The analysis population was to include all randomized patients who took at least one dose of study medication (ITT population). However, due to early study termination, only 2 patients were randomized and they did not have sufficient follow up. Hence the planned efficacy analysis could not be carried out.||||||
1438432|NCT00946920|Secondary|Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline|"IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and a score of 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia."|At baseline, 1 month, 4 months, 7 months and 13 months|FAS.|||units on a scale||Standard Deviation|Mean
1438433|NCT00946920|Secondary|Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline|The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.|At baseline, 10 months and 13 months|FAS.|||units on a scale||Standard Deviation|Mean
1438434|NCT00946920|Secondary|Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time|Serum PSA levels are presented as mean percent change from Baseline (in Baseline measures) after 1, 2, 3, 6 and 13 months. One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.|||percent change||Standard Deviation|Mean
1438435|NCT00946920|Secondary|Serum Levels of Testosterone Over Time|Median testosterone levels are presented as absolute values at Baseline (in Baseline measures) and after 1, 2, 3, 6 and 13 months (below). One treatment month equals 28 days.|Baseline and after 1, 2, 3, 6 and 13 months|FAS.|||ng/mL||Full Range|Median
1438436|NCT00946920|Primary|Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin|This co-primary outcome measure was used to establish non-inferiority of degarelix as compared to goserelin with regard to achieving and maintaining testosterone suppression at castrate levels (≤0.5 ng/mL) from Day 3 to Day 364, using a non-inferiority margin of 5 percentage points.|Day 3 to Day 364|FAS.|||percentage of participants||95% Confidence Interval|Number
1438437|NCT00946920|Primary|Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix|This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.|From Day 28 to Day 364|FAS.|||percentage of participants||95% Confidence Interval|Number
1438438|NCT00946881|Secondary|Pharmacokinetic Parameters -T1/2|For each dose group, several pharmacokinetics parameters have been calculated.|T0, 5 min,10 min, 4 h, 8 h, post dose|Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.|||hours||Standard Deviation|Mean
1438439|NCT00946881|Secondary|Pharmacokinetic Parameters-Tmax|For each dose group, several pharmacokinetics parameters have been calculated.|T0, 5 min,10 min, 4 h, 8 h, post dose|Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.|||hours||Standard Deviation|Mean
1438440|NCT00946881|Secondary|International Prostate Symptom Score (IPSS) Results|The International Prostate Symptom Score (IPSS) is a 7 questions patients auto-questionnaire about urinary symptoms. the possible scores range are 0 to 35 . Best score is 0 worst score is 35|Month 1, Month 3 , Month 6 , Month 12|IPSS results|||units on a scale||Standard Deviation|Mean
1438441|NCT00946881|Secondary|International Index of Erectile Functions (IIEF) Results|The International Index of Erectile Functions questionnaire is 15 questions patients auto questionnaire. The results presented are those of the erectile function domain which comprise 6 questions. Possible scores range is 1 to 30 . Best score is 30, worst score is 1.|Month 1-Month 3- Month 6- Month 12||||units on a scale||Standard Deviation|Mean
1438442|NCT00946881|Secondary|Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI|"The adjusted prostate necrosis percentage was defined as follows:~The Day 7 necrosis percentage is the proportion, expressed in %, of Day 7 prostate necrosis volume by planimetry in the treated lobe compared with half the prostate volume by planimetry, considering the average between the baseline volume and Day 7 volume;"|Day 7||||percentage of prostatic necrosis||Standard Deviation|Mean
1438443|NCT00946881|Secondary|Pharmacokinetic Parameters-Cmax|For each dose group, several pharmacokinetics parameters have been calculated.|T0, 5 min,10 min, 4 h, 8 h, post dose|Out of 30 patients treated in the study, 29 patients had pharmacokinetic data available.|||ng/mL||Standard Deviation|Mean
1438444|NCT00946881|Primary|Prostate Biopsies|Number of patients who had a negative biopsy at Month-6|Month-6||||Participants|||Count of Participants
1438445|NCT00946881|Primary|Prostate Biopsy|"Arm/Group Title:~WST 11(TOOKAD® Soluble) Arm/Group Description To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe"|Month 6||||participants|||Number
1438446|NCT00946530|Secondary|WASO (Wake After Sleep Onset)|WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.|2 weeks||||units on a scale (minutes)||Standard Deviation|Mean
1438447|NCT00946530|Primary|Total Sleep Time|The amount of actual sleep time in a sleep episode.|2 weeks|dyads consisting of 1 AD patient and 1 caregiver|||units on a scale (minutes)||Standard Deviation|Mean
1438448|NCT00946478|Primary|Cathelicidin mRNA Expression Levels in Adult Skin From Patients With AD|Delta-delta CT values were measured using RT-PCR of cathelicidin mRNA in human biopsy samples at baseline, and then 3 weeks after treatment with either pimecrolimus or placebo|3 weeks||||delta-delta ct units on PCR||Standard Error|Mean
1438450|NCT00946348|Primary|fMRI Connectivity of Regions of Interest (ROI) Within the Brain Reward Circuitry (BRC).|Average Z scores for the region-of-interest functional connectivity at the second scan (when subjects received either a cannabis cigarette or 15mg of dronabinol) between the bilateral nucleus accumbens (NAc) and ventral anterior cingulate cortex (vACC) for patients with schizophrenia and co-occurring cannabis use disorder.|Measures were acquired at peak THC level for each of the two drugs up to 4 hours.||||Z score||Standard Deviation|Mean
1438451|NCT00946322|Secondary|Partner-reported Dyadic Adjustment Scale|Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed.|||units on a scale||Standard Deviation|Mean
1438452|NCT00946322|Secondary|Partner-reported Beck Depression Inventory - II|Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing the pre- and post-treatment assessment were included|||units on a scale||Standard Deviation|Mean
1438453|NCT00946322|Primary|Partner-reported PTSD Checklist|Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment|||units on a scale||Standard Deviation|Mean
1438454|NCT00946322|Primary|Patient-reported PTSD Checklist|Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were included.|||units on a scale||Standard Deviation|Mean
1438455|NCT00946322|Secondary|Patient-reported Dyadic Adjustment Scale|Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessment were analyzed|||units on a scale||Standard Deviation|Mean
1438456|NCT00946322|Secondary|Patient-reported Beck Depression Inventory - II (BDI-II)|Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.|Pre- to post-treatment|Participants completing the BDI-II at pre- and post-treatment were analyzed|||units on a scale||Standard Deviation|Mean
1438457|NCT00946322|Primary|Percentage Days of Heavy Drinking|Percentage days of heavy drinking (PDHD) was calculated by dividing the number of days in which the Veteran consumed more than six standard drinks by the total days in the period. Both partners reported upon the Veterans’ drinking behaviors. Following common practice in AUD research (e.g., McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2011), we used the highest report of the two regarding PDHD to reduce possible underreporting. Possible range of scores 0-100%. Higher = worse.|Pre- to post-treatment (~20 weeks)|Participants completing pre- and post-treatment assessments were analyzed|||percentage of days of heavy drinking||Standard Deviation|Mean
1438458|NCT00946322|Primary|Clinician-administered PTSD Scale (CAPS)|Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.|Pre- to post-treatment (~20 weeks)|Participants completing both pre- and post-treatment assessments were analyzed.|||units on a scale||Standard Deviation|Mean
1438459|NCT00946309|Primary|3-alpha-diol Gluconate Levels|Change in serum 3-alpha-diol gluconate(3α-DG) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants|||ng/mL||Standard Deviation|Mean
1438460|NCT00946309|Primary|Testosterone Levels|Change in testosterone (T) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants|||ng/dL||Standard Deviation|Mean
1438461|NCT00946309|Primary|DHT Levels|Change in serum dihydrotestosterone (DHT) levels|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 25 participants|||pg/mL||Standard Deviation|Mean
1438462|NCT00946309|Primary|DNA Oxidation|Prostate tissue 8-hydroxy-2’-deoxyguanosine (8OHdG) levels|Five weeks|Outcome data were not collected due to budget restrictions||||||
1438463|NCT00946309|Primary|Lipid Oxidation|Blood F2 Isoprostane levels|Baseline and 5 weeks|Outcome data were not collected due to budget restrictions||||||
1438464|NCT00946309|Primary|Gene Expression of Phase II Enzymes|Change in Phase II enzyme expression|Baseline and 5 weeks|Due to budget restrictions, outcome data from only collected from the first 20 participants|||-fold change in expression||Standard Deviation|Mean
1438465|NCT00946296|Primary|Blood Loss During Surgery|Blood loss in milliliters during surgery.|up to 162 minutes||||mL||Standard Deviation|Mean
1438466|NCT00946114|Primary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse event = any untoward medical occurrence in a subject administered study medication regardless of causality including abnormal test findings, clinically significant signs/symptoms, changes in physical examination findings, hypersensitivity, progression/worsening of underlying disease, and exposure in utero. Serious adverse event = any untoward medical occurrence at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, or resulted in persistent or significant disability/incapacity or congenital anomaly/birth defect.|Baseline up to 116 Weeks|Safety population: all subjects assumed to have taken at least one dose of study medication. Non-serious adverse events were reported up to 7 days after the last dose of study medication. Serious adverse events were reported up to 28 days after the last dose of study medication.|||participants|||Number
1438467|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).|||titer||Full Range|Geometric Mean
1438468|NCT00946101|Secondary|Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).|||titer||Full Range|Geometric Mean
1438503|NCT00946088|Primary|Reduction in Delivery Rate Prior to 37 Weeks Gestation|Reduction in delivery rate prior to 37 weeks gestation (preterm birth).|Up to 37 weeks of gestation||||Participants|||Count of Participants
1438469|NCT00946101|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).|||titer||Full Range|Geometric Mean
1438470|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).|||participants|||Number
1438471|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=126; Placebo=32).|||participants|||Number
1438472|NCT00946101|Secondary|Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).|||participants|||Number
1438473|NCT00946101|Secondary|Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438474|NCT00946101|Secondary|Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||Participants|||Number
1438475|NCT00946101|Secondary|Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
1438476|NCT00946101|Secondary|Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
1438477|NCT00946101|Secondary|Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438478|NCT00946101|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438504|NCT00946023|Secondary|Graft Failure|Percentage of participants who failed to engraft.|Day 60|Two participants were not analyzed because they died prior to Day 60.|||Participants|||Count of Participants
1438479|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
1438480|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
1438481|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2||Days 29-43|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).|||participants|||Number
1438482|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo=65) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
1438483|NCT00946101|Secondary|Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population included all participants who received Dose 2 (H1N1=258; Placebo) and experienced any follow-up for safety (H1N1=255; Placebo=63).|||participants|||Number
1438484|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2||Days 29-36|The safety population for solicited symptoms Dose 2 included all participants who received Dose 2 (H1N1=258; Placebo=65), experienced any follow-up for safety and had solicited symptom data available during the reporting period (H1N1=255; Placebo=63).|||participants|||Number
1438485|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438486|NCT00946101|Secondary|Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438487|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1||Days 1-15|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety, and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).|||participants|||Number
1438488|NCT00946101|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438489|NCT00946101|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1||Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65) and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438490|NCT00946101|Secondary|Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1|Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.|Days 1-8|The safety population included all participants who received at least one dose of investigational product (H1N1=259; Placebo=65), experienced any follow-up for safety and had solicited symptoms data available during the reporting period (H1N1=259; Placebo=65).|||participants|||Number
1438491|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).|||participants|||Number
1438492|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).|||participants|||Number
1438493|NCT00946101|Primary|Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.|Day 1, Day 15|Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).|||participants|||Number
1438494|NCT00946101|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.|Days 1- 8|The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).|||participants|||Number
1438508|NCT00946023|Secondary|Incidence of Grades II-IV Acute Graft-versus-Host-Disease (GVHD)|Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
1438509|NCT00946023|Secondary|Non-relapse Mortality|Percentage of participants who died due to BMT-related reasons.|1 year post intervention||||percentage of participants||95% Confidence Interval|Number
1438510|NCT00946023|Secondary|Relapse|Percentage of participants alive with relapse or disease progression.|2 years post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
1438511|NCT00946023|Secondary|Relapse|Percentage of participants alive with relapse or disease progression.|1 year post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
1438512|NCT00946023|Secondary|Overall Survival|Percentage of participants alive.|2 years post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
1438513|NCT00946023|Secondary|Overall Survival|Percentage of participants alive.|1 year post intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
1438514|NCT00946023|Secondary|Progression-free Survival|Percentage of participants alive with and without relapse.|2 years post-intervention|"Populations were analyzed as follows:~All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
1438515|NCT00946023|Primary|Progression-free Survival|Percentage of participants alive and without relapse or disease progression.|1 year post-intervention|"Populations were analyzed as follows:~All participants~Recipients of haploidentical donors (69 participants)~Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)"|||percentage of participants||95% Confidence Interval|Number
1438516|NCT00945958|Secondary|Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)|From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured|24 weeks|From the start of the study through Week 24 (Visit 7, End of Evaluations), the change in IOP is evaluated|||mm Hg||Standard Deviation|Mean
1438517|NCT00945958|Primary|Number of Subjects With AEs|Subjects with treatment emergent adverse events|24 weeks||||participants|||Number
1438518|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in 36-item Short-Form Health Survey|Self-reported questionnaire with 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438519|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in European Quality of Life Questionnaire (EQ-5D)|Patients rate their health state in 5 domains: mobility, self-care, usual activities, pain, and mood. Score between 1-3 is generated for each domain which is mapped to single index score. Index ranges between 0-1; higher scores indicate better health perceived by patient. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438520|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Profile of Mood States- Brief Form (BPOMS)|BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0-20. Total score = sum of all factor scores minus vigor score. Due to nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438521|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint(13 Week) in Intermittent and Constant Osteoarthritis Pain: Knee Version|An 11-item questionnaire to individually and jointly assess intermittent and constant pain. Questions assess intensity and impact of pain on activity and emotion. Each item is scored from 0 to 4; higher values indicate higher severity. Total Pain score ranges from 0-44. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438522|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438523|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) in Brief Pain Inventory- Interference Score|Interference scores range from 0 (does not interfere) to 10 (completely interferes) on 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Total score ranges from 0-70. Due to the nature of study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438524|NCT00945945|Secondary|Mean Change of Total Score From Baseline to Endpoint (13 Week) of Brief Pain Inventory-Severity (BPI-S) Scale|Self-reported scale measuring pain severity. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Four questions assess worst pain, least pain, and average pain in the past 24 hours, and pain right now. Total score ranges from 0-40. Due to the nature of a study drug labeling error and resultant treatment crossover, data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438525|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Western Ontario McMaster Universities (WOMAC) Index Score|The WOMAC index (pain, stiffness, physical function subscales) was completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|baseline, 13 weeks||||units on a scale||Standard Deviation|Mean
1438526|NCT00945945|Secondary|Mean Change From Baseline to Endpoint (13 Week) in Patient's Global Impressions of Improvement Score|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Due to the nature of a study drug labeling error and the resultant treatment crossover (see Arms), the data from both protocol-defined treatment groups were compromised, and the intended comparisons for differences between those treatment groups are considered unevaluable. Secondary efficacy results from the 2 mixed-treatment groups are not presented.|Baseline, 13 weeks||||participants||Standard Deviation|Mean
1438527|NCT00945945|Secondary|Number of Participants With Suicidal Behaviors and Ideations From the Columbia Suicide Severity Rating Scale|C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors and ideations are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.|Baseline through 13 weeks|All randomized participants.|||participants|||Number
1438528|NCT00945945|Primary|"Change From Baseline to 13 Week Endpoint (Baseline Observation Carried Forward [BOCF]) in Brief Pain Inventory (BPI) 24-Hour Average Pain Item (Question 3) of the BPI-Modified Short Form Score"|A self-reported measure of the severity of pain based on the average pain over 24-hours. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). BOCF endpoint was defined as the baseline value for participants discontinued during acute phase, and defined as the last non-missing observation in the treatment phase for all other randomized participants. Due to the nature of a study drug labeling error which led to a treatment crossover (see Arms), data from protocol-defined treatment groups were compromised. The results from each mixed-treatment group are presented.|Baseline, 13 weeks|Number of randomized participants with a non-missing baseline and BOCF endpoint.|||units on a scale||Standard Deviation|Mean
1438529|NCT00945906|Secondary|Number of Bleeding Episodes|Number of bleeding episodes at any time after the first infusion in the study.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||Episodes|||Number
1438530|NCT00945906|Secondary|Number of Subjects With at Least One Bleeding Episode|Number of subjects with at least one bleeding episode at any time after the first infusion in the study, and the number of subjects with at least one bleeding episode requiring Factor XIII treatment.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||participants|||Number
1438531|NCT00945906|Secondary|FXIII Concentration|Trough Factor XIII concentration.|Before the first infusion, at 24 and 48 weeks after the first infusion, and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||Units/mL||Standard Deviation|Mean
1438532|NCT00945906|Secondary|FXIII Antibody Testing|Number of participants with serum Factor XIII antibodies.|Before the first infusion, then every 48 weeks, at the end-of-study (or withdrawal) visit and after a bleeding episode requiring treatment with a Factor XIII -containing product.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||participants|||Number
1438533|NCT00945906|Secondary|Hematology and Chemistry Testing|Number of participants with treatment-emergent clinically significant hematology and/or chemistry laboratory parameter values.|After the first infusion and at the end-of-study (or withdrawal) visit.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study.|||participants|||Number
1438576|NCT00945555|Secondary|Mean Neutrophil Count||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with available data. n=number of participants with data available at that time point.|||neutrophils per cubic millimeter||Standard Deviation|Mean
1438534|NCT00945906|Primary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment-related AEs are defined as AEs whose relationship to treatment is related, or possibly related and AEs with missing relationship.|After the first infusion until study completion. Study completion is up to 2 years or until Factor XIII Concentrate (Human) is commercially available in the USA.|The Safety Population consisted of all subjects who received a dose of Factor XIII Concentrate (Human) during the study. Treatment related AEs are events whose relationship to study treatment is related, or possibly related, in the opinion of the investigator. AEs with missing relationship are considered related to treatment.|||participants|||Number
1438535|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 2 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.|||Titer||Full Range|Geometric Mean
1438536|NCT00945893|Secondary|Serum HAI GMTs in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 29)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Titer||Full Range|Geometric Mean
1438537|NCT00945893|Secondary|Serum HAI Geometric Mean Titers (GMTs) in All Participants Regardless of Baseline Serostatus, Dose 1 (Day 15)|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Titer||Full Range|Geometric Mean
1438538|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 2 (Day 57) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.|||Participants|||Number
1438539|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 29) HAI Titer ≥ 32 Against the H1N1 Strain in All Subjects Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 29|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
1438540|NCT00945893|Secondary|Number of Participants Who Achieved a Post Dose 1 (Day 15) HAI Titer ≥ 32 Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|All immunogenicity analyses are based on the immunogenicity population.|Day 1, Day 15|Participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
1438541|NCT00945893|Secondary|Number of Participants With NOCDs Through 180 Days Post Final Dose.|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438542|NCT00945893|Secondary|Number of Participants With SAEs Through 180 Days Post Final Dose|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-209|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438543|NCT00945893|Secondary|Number of Participants With NOCDs Within 28 Days Post Vaccination, Dose 2|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any safety follow-up during the reporting period.|||Participants|||Number
1438544|NCT00945893|Secondary|Number of Participants With SAEs Through 28 Days Post Vaccination, Dose 2|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 29-57|Participants in the Safety Population for Dose 2 who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
1438577|NCT00945555|Secondary|Mean Body Temperature||Baseline, Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. n=number of participants with available data at that time point.|||Degree Celsius||Standard Deviation|Mean
1438545|NCT00945893|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination, Dose 1|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438546|NCT00945893|Secondary|Number of Participants With Serious Adverse Events (SAEs) Through 28 Days Post Vaccination, Dose 1|SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 1-29|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438547|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
1438548|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
1438549|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 2||Days 29-43|Participants in the Safety Population who received Dose 2 and had solicited symptom data available during the reporting period.|||Participants|||Number
1438550|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the safety population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
1438551|NCT00945893|Secondary|Number of Participants Reporting AEs Within 7 Days Post Vaccination, Dose 2||Days 29-36|Participants in the Safety Population who received Dose 2 and had any follow-up for safety during the reporting period.|||Participants|||Number
1438552|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 2||Days 29-36|The Safety Population for solicited symptoms dose 2 was defined as all participants who received Dose 2, had any follow-up for safety and had solicited symptom data available during the reporting period.|||Participants|||Number
1438553|NCT00945893|Secondary|Number of Participant Using Anti-pyretic and Analgesic Agents Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438554|NCT00945893|Secondary|Number of Participants Reporting AEs Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438555|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 14 Days Post Vaccination, Dose 1||Days 1-15|The Safety Population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.|||Participants|||Number
1438556|NCT00945893|Secondary|Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days Post Vaccination, Dose 1.||Days 1-8|The Safety population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438557|NCT00945893|Secondary|Number of Participants Reporting Adverse Events (AEs) Within 7 Days Post Vaccination, Dose 1||Days 1-8|The Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438558|NCT00945893|Secondary|Number of Participants With Any Solicited Symptom Within 7 Days Post Vaccination, Dose 1|Solicited symptoms were events considered likely to occur post dosing. For this study, other solicited symptoms included: Fever (> 100°F [37.8°C] oral), Runny nose, Sore throat, Cough, Vomiting, Muscle aches, Chills, Decreased activity (tiredness), and Headache.|Days 1-8|The Safety population for solicited symptoms was defined as all participants who received at least one dose of investigational product, had any follow-up for safety and had solicited symptom data available during the reporting period.|||Participants|||Number
1438559|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 57|Participants who received 2 doses of the same investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis.|||Participants|||Number
1438560|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 29|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
1438644|NCT00944710|Secondary|Mean Fellow-Eye Visual Acuity at 12-week Exam||12 weeks after randomization||||logMAR||Standard Deviation|Mean
1438645|NCT00944710|Secondary|Distribution of 12-week Fellow-Eye Visual Acuity|Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.|12 weeks after randomization||||participants|||Number
1438561|NCT00945893|Primary|Number of Participants Who Experienced a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus|Seroresponse was defined as a ≥ 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses were based on the immunogenicity population.|Day 1, Day 15|For each treatment group, participants were randomized at a 1:1 ratio to have their post Dose 1 immunogenicity blood draw occur on either Day 15 or Day 29. Participants who received Dose 1 of the investigational product and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis.|||Participants|||Number
1438562|NCT00945893|Primary|Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C).|The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses • H0 (null): rate difference ≥ 10% • HA (alternative): rate difference < 10%|Days 1-8|Safety Population was defined as all participants who received at least one dose of investigational product and had any follow-up for safety.|||Participants|||Number
1438563|NCT00945854|Secondary|Postprandial Plasma Lipid Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of triglyceride response reported as average mean postprandial increment.|12 weeks||||mg/dlx3hrs||Standard Deviation|Mean
1438564|NCT00945854|Secondary|Postprandial Insulin Changes|Blood samples during the standard meal test were drawn from an antecubital vein after a 12 h overnight fast and 0, 30, 60, 90, 120, 150 and 180 min postprandial for the measurement of plasma insulin response reported as average mean postprandial increment.|12 weeks||||(microU/mlx3hrs)||Standard Deviation|Mean
1438565|NCT00945854|Primary|Insulin Sensitivity (Si)|Peripheral insulin sensitivity was assessed by FSIGT. A glucose dose of 300 mg/kg body weight was given intravenously followed by a bolus of 0.03 U/kg of insulin injected after 20 min. Blood samples were frequently collected for 3 h for the measurement of plasma glucose and serum insulin concentrations, utilized to calculate the insulin sensitivity index Si|12 weeks||||104xmin-1/microU/ml||Standard Error|Mean
1438566|NCT00945815|Primary|Complete Remission|Complete remission (CR) is defined as: <5% marrow aspirate blasts. Blasts can be >=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils >= 1000/mcl; platelets >100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be <=100,000/mcl and/or ANC may be <1,000/mcl.|After induction therapy was completed (1 or 2 months)|Eligible patients who began protocol therapy.|||percentage of participants||95% Confidence Interval|Number
1438567|NCT00945815|Secondary|Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|Up to 5 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries.|||Participants|||Number
1438568|NCT00945750|Secondary|Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL||95% Confidence Interval|Geometric Mean
1438569|NCT00945750|Secondary|AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL hr||95% Confidence Interval|Geometric Mean
1438570|NCT00945750|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL||95% Confidence Interval|Geometric Mean
1438571|NCT00945750|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water|AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose|Participants who completed the study|||ng/mL hr||95% Confidence Interval|Geometric Mean
1438572|NCT00945555|Secondary|Percentage of Participants Who Had a Treatment Modification||Day 4, Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants who had a treatment modification at any time point. n=number of participants who had data available at that specific time point.|||percentage of participants|||Number
1438573|NCT00945555|Secondary|Percentage Survivors||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed=number of participants with data available.|||percentage of participants|||Number
1438574|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined at End of Treatment||Day 7 on Average (till the End of Treatment)|All participants enrolled in the study. Number of participants analyzed = number of participants with new infection diagnosed at end of treatment.|||percentage of participants|||Number
1438575|NCT00945555|Secondary|Percentage of Participants in Whom New Infection Was Determined on Day 4||Day 4|All participants enrolled in the study. Number of participants analyzed=participants with new infection diagnosed on Day 4.|||percentage of participants|||Number
1438646|NCT00944710|Secondary|Mean Interocular Difference at 12-week Exam|Mean Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization||||logMAR lines||Standard Deviation|Mean
1438578|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted||Baseline|All participants enrolled in the study who received treatment for febrile neutropenia. Number of participants analyzed=number of participants who received an antibacterial drug for the treatment of febrile neutropenia. Participants may be counted more than once because they may have received more than one antibacterial agent.|||percentage of participants|||Number
1438579|NCT00945555|Primary|Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical||Baseline|All participants enrolled in the study. Participants may be counted more than once because they may have received more than one antibacterial agent.|||percentage of participants|||Number
1438580|NCT00945477|Secondary|Number Adverse Events, Grades 1-5 Using NCI-CTCAE v 3.0|Safety was evaluated by documentation of Adverse Events (AEs), by assessment of clinical laboratory findings, and by physicial examination, including measurement of vital signs and weight in all eleven subjects.|0-12 weeks|The adverse events for all participants enrolled were evaluated by documentation of Adverse Events (AEs)Grades 1-5 using NCI-CTCAE v 3.0|||Adverse events Grade 1-5|||Number
1438581|NCT00945477|Primary|Response Rate at 12 Weeks|Response rate defined as 50% decrease in the Prostate Specific Antigen (PSA) level at week 12 compared to baseline|12 weeks|Five subjects completed the 12 week treatment requirement.|||participants|||Number
1438582|NCT00945334|Secondary|Change in Methane From Baseline|"Methane output was reported as methane in parts per million (ppm) on breath test:~Subjects fast for 12 h prior to a breath sample. Breath samples were collected via a Quintron dual bag collecting system and analyzed using a BreathTracker SC. Output was reported as methane in parts per million (ppm) after correction for alveolar sample quality using breath CO2 concentration."|Baseline (Day 0) and Final Visit (Day 44)|Change in breath test methane gas levels: baseline breath test minus final breath test measurement.|||parts per million||Standard Deviation|Median
1438583|NCT00945334|Primary|Severity of Constipation in Each Arm at Week 1 After Completion of Therapy|"Visual analog scale (VAS) score for constipation:~Severity was rated using a VAS from 0 to 100 units (with 0 = no symptom and 100 = severe symptoms)."|1 year||||units on a scale||Standard Deviation|Mean
1438584|NCT00945321|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg.||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.|||ng/mL||Standard Error|Mean
1438585|NCT00945321|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg||Through 72 Hours Postdose|All subjects excluding one subject who dropped from the study after Period 1 due to accidental overdose were included in the pharmacokinetic (PK) analysis.|||ng•hr/mL||Standard Deviation|Mean
1438586|NCT00945295|Secondary|Length of Time to Meet Re-injection Criteria and the Number of Participants That do Not Meet Re-injection Criteria Prior to Completion of the Study.||6 Weeks||||number|||Number
1438587|NCT00945295|Primary|The Maximum Change in Fugl-Meyer Upper Extremity Score From the Baseline Exam to Any Post Injection Visit in Each Treatment Arm. Comparison of the Difference Scores Between the Two Groups Will be Considered Significant at p < 0.05.||6 Weeks||||difference|||Number
1438588|NCT00945256|Primary|Mixed Muscle Fractional Synthesis Rate (FSR)|The rate at which the body makes new muscle was assessed by determining the fractional synthesis rate (FSR). This technique determines how quickly new amino acids are used to make muscle. In this technique, a special (but natural and non-radioactive) version of an amino acid is infused into the blood. This special version of the amino acid is heavier than the most common version the same amino acid. This property allows it to be identified in a muscle sample. By determining how much of the special amino acid has accumulated over time in a muscle sample, the fractional synthesis rate can be determined. For example, if the rate were such that 1 of every 100 amino acids were of the special type after 1 day, the fractional synthesis rate would be 1% per day. In other words, 1/100 of the muscle would be newly made each day.|Acute ( 8 hours)|FSR was not calculated for the Elderly Sodium Nitroprusside with Amino Acid Drink arm of the study.|||Fractional Synthesis Rate (pecent/hour)||Standard Error|Mean
1438589|NCT00945243|Secondary|Implant Related Complications|Percentage of subjects who had an implant related complication|24 months|11 subjects were enrolled and treated on protocol and were thus considered for safety information|||percentage of subjects|||Number
1438590|NCT00945243|Secondary|Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)|Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.|24 months|8 subjects had data at 24 months.|||percentage of subjects|||Number
1438591|NCT00945243|Primary|Assessment of Neck Disability Index Scores|Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.|24 months|8 subjects had data at 24 months|||percentage of subjects|||Number
1438592|NCT00945139|Primary|Progression Free Survival (PFS) by GCIC Criteria|Using GCIC criteria, progression is defined as CA-125 levels greater than, or equal to, 2 times the upper limit of a reference range on 2 occasions and at least 1 week apart.|Up to 25 months|28 out of 46 enrolled patients were assessable for PFS per GCIC criteria. The remaining patients could not be evaluated for this endpoint because the timing of their CA-125 measurements did not meet the defined criteria.|||Months||95% Confidence Interval|Median
1438593|NCT00945139|Secondary|Overall Response Rate (ORR) by GCIC Criteria|A response according to GCIC criteria has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA-125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment.|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||percentage of participants||95% Confidence Interval|Number
1438647|NCT00944710|Secondary|Distribution of Interocular Difference at 12-week Exam|Distribution of Interocular Difference Between Eyes at 12-week Exam|12 weeks after randomization||||participants|||Number
1438594|NCT00945139|Secondary|Clinical Benefit Rate (by RECIST)|Clinical Benefit Rate (CBR) is the sum of the percentages of patients achieving complete response, partial response, and stable disease. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||percentage of participants||95% Confidence Interval|Number
1438595|NCT00945139|Secondary|Overall Response Rate (ORR) by RECIST|ORR is the sum of the percentages of patients achieving complete and partial responses. Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0)|3 years|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||Percentage of participants||95% Confidence Interval|Number
1438596|NCT00945139|Secondary|Overall Survival|The time from treatment initiation to death by any cause|4 years||||Months||Full Range|Median
1438597|NCT00945139|Primary|Progression Free Survival (PFS) by RECIST Criteria|Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by hysical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 25 months|43 out of 46 enrolled patients were assessable for PFS by RECIST criteria. The remaining patients could not be evaluated for this endpoint because of missed imaging scans that prevented analysis according to the defined criteria.|||Months||Full Range|Median
1438598|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization for Participants With Anisometropic Amblyopia||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with anisometropic amblyopia (no strabismus) who had measureable stereoacuity at randomization and at the 10-week primary outcome exam.|||participants|||Number
1438599|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks for Participants With Anisometropic Amblyopia||10 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.|||participants|||Number
1438600|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization for Participants With Anisometropic Amblyopia||Randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 10-week exam.|||participants|||Number
1438601|NCT00945100|Secondary|Change in Randot Preschool Stereoacuity Level at 10-week Outcome Since Randomization||10 weeks after randomization|Change in stereoacuity level at 10 weeks was computed for participants with measureable stereoacuity at randomization and at the 10-week primary outcome exam.|||participants|||Number
1438602|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 10 Weeks||10 weeks after randomization|The analysis includes all participants who completed the 10-week exam.|||participants|||Number
1438603|NCT00945100|Secondary|Distribution of Randot Preschool Stereoacuity Scores at Randomization|"The Preschool Randot test measures random dot stereoacuity from 800 to 40 arc seconds (800, 400, 200, 100, 60, 40). Lower scores indicate better stereoacuity and subjects who fail the first level (800 seconds of arc) are assigned a score of >800.~We administer a pretest, and those with a failed or uninterpretable score do not proceed with the Randot testing.~The Preschool Randot test consists of 3 booklets each with 2 sets of 4 random dot shapes (one is blank, 3 are actual figures), which can be matched to non-stereo shapes on the opposite side of the booklets. There are six levels (seconds of arc) in the test with two levels in each book. Each level has 4 rectangles that contain 3 shapes and one blank."|Randomization|The analysis includes all participants who completed the 10-week exam.|||participants|||Number
1438604|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later||||logMAR lines||Standard Deviation|Mean
1438605|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
1438606|NCT00945100|Secondary|Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||logMAR lines||Standard Deviation|Mean
1438607|NCT00945100|Secondary|Distribution of Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||participants|||Number
1438608|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR||Standard Deviation|Mean
1438609|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at Final Visit||10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
1438610|NCT00945100|Secondary|Mean Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||logMAR||Standard Deviation|Mean
1438611|NCT00945100|Secondary|Distribution of Best Fellow Eye Visual Acuity at 10-week Outcome||10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||participants|||Number
1438612|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The proportion of participants who improved at least 2 logMAR lines since randomization was computed based on the best post-randomization visual acuity in the amblyopic eye. The initial visual acuity score was used if a retest was obtained.|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
1438613|NCT00945100|Secondary|Mean Change in Amblyopic Eye Visual Acuity Since Randomization at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR lines||Standard Deviation|Mean
1438614|NCT00945100|Secondary|Distribution of the Change in Best Post-randomization Visual Acuity in the Amblyopic Eye|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
1438615|NCT00945100|Secondary|Mean Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR||Standard Deviation|Mean
1438616|NCT00945100|Secondary|Distribution of Amblyopic Eye Visual Acuity at Visit of Best Post-randomization Visual Acuity|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
1438617|NCT00945100|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||units on a scale||Standard Deviation|Mean
1438618|NCT00945100|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||logMAR||Standard Deviation|Mean
1438619|NCT00945100|Primary|Mean Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR lines||Standard Deviation|Mean
1438620|NCT00945100|Primary|Distribution of the Change in Amblyopic Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
1452609|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 01 from Baseline (i.e., between -45 days and +2 weeks)||||mg/dL||Standard Deviation|Mean
1438621|NCT00945100|Primary|Mean 10-week Amblyopic Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR||Standard Deviation|Mean
1438622|NCT00945100|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive)according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
1438623|NCT00945100|Secondary|Treatment Group Comparison of 10-week Interocular Difference|The secondary outcome analysis was a treatment group comparison of the 10-week interocular difference (IOD), computed as the difference between the masked amblyopic and fellow eye visual acuities, using an analysis of covariance (ANCOVA) model, adjusting for IOD at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||logMAR lines||Standard Deviation|Mean
1438624|NCT00945100|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
1438625|NCT00945100|Secondary|Average Compliance With Prescribed Patching by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization or later||||participants|||Number
1438626|NCT00945100|Secondary|Compliance With Prescribed Patching by Treatment Group at 10 Weeks|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the number of hours the child patched each day.|10 weeks after randomization||||participants|||Number
1438627|NCT00945100|Primary|Distribution of 10-week Amblyopic Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
1438628|NCT00945035|Primary|Peak Plasma Concentration (Cmax) for Etoricoxib||Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.|||ng/mL||Standard Deviation|Least Squares Mean
1438629|NCT00945035|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib|The area under the plasma concentration vs time curve.|Through 120 Hours Postdose|All healthy adult subjects completed the study and were included in the statistical analysis.|||µg times hr/mL||Standard Deviation|Least Squares Mean
1438630|NCT00944749|Primary|Number of Participants With Complete Response at 3 Months.|"The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA).~A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb > 10 g/dL, and platelet count > 100×109/L.~A partial response was defined as a hematologic response that was not sufficient for a complete response.~In subjects with a non-robust hematologic response at 3 months, improvement in one or more of the listed peripheral blood parameter (a,b,c) were recorded as a response: a) ANC - if baseline ANC below 0.5×109/L, increase in ANC by > 0.3×109/L, if baseline ANC above 0.5×109/L, any increase in ANC by > 0.5×109/L of blood; (b) platelets - if baseline platelet count < 50×109/L, any increase in platelet count by > 20×109/L of blood; c) hemoglobin - any increase in hemoglobin by 1.5 g/dl of blood in transfusion-independent patients and in absolute reticulocyte count to > 60×109/L of blood in transfusion-dependent patients."|3 months||||Participants|||Count of Participants
1439122|NCT00942890|Secondary|Pain Severity|"Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its worst, least, average, and current level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items."|0, 3, 6, 9, 12 wks||||units on a scale||Standard Deviation|Mean
1438631|NCT00944749|Primary|Number of Participants With Complete Response at 3 Months.|"The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA) defined as bone marrow cellularity of less than 30% and severe pancytopenia with at least two of the following peripheral blood count criteria: (i) absolute neutrophil count less than 0.5×109/L; (ii) absolute reticulocyte count less than 60×109/L; and (iii) platelet count less than 20×109/L.~A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb > 10 g/dL, and platelet count > 100×109/L.~A partial response was defined as a hematologic response that was not sufficient for a complete response."|3-months||||Participants|||Count of Participants
1438632|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia||12 weeks after randomization|The analysis includes participants with anisometropic amblyopia (no strabismus) who completed the 12-week exam.|||participants|||Number
1438633|NCT00944710|Secondary|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks|Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of >800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.|12 weeks after randomization|The analysis includes all participants who completed the 12-week exam.|||participants|||Number
1438634|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit||10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)||||participants|||Number
1438635|NCT00944710|Secondary|Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR lines||Standard Deviation|Mean
1438636|NCT00944710|Secondary|Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
1438637|NCT00944710|Secondary|Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||logMAR||Standard Deviation|Mean
1438638|NCT00944710|Secondary|Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit|Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit. The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)|The analysis includes data from participants who completed the 10-week exam and/or a later visit.|||participants|||Number
1438639|NCT00944710|Secondary|Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics|A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||logMAR lines||Standard Deviation|Mean
1438640|NCT00944710|Secondary|Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome|Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors. The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles of the primary outcome analysis.|||logMAR||Standard Deviation|Mean
1438641|NCT00944710|Secondary|Distribution of Baseline Characteristics at the 10-week Outcome|The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.|10 weeks after randomization|The analysis included participants who completed 10-week exams between 8 and 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
1438642|NCT00944710|Secondary|Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization||||change in lines||Standard Deviation|Mean
1438643|NCT00944710|Secondary|Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization||12 weeks after randomization||||participants|||Number
1438648|NCT00944710|Primary|Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization|"The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR lines||Standard Deviation|Mean
1438649|NCT00944710|Primary|Distribution of the Change in Amblyopic-Eye Visual Acuity|"The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|Randomization to 10 weeks|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
1438650|NCT00944710|Primary|Mean 10-week Amblyopic-Eye Visual Acuity|"The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||logMAR||Standard Deviation|Mean
1438651|NCT00944710|Secondary|Average Atropine Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)||||participants|||Number
1438652|NCT00944710|Secondary|Atropine Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization||||participants|||Number
1438653|NCT00944710|Secondary|Average Spectacle Compliance by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)||||participants|||Number
1438654|NCT00944710|Secondary|Spectacle Compliance at 10 Weeks by Treatment Group|The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome. Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.|10 weeks after randomization||||participants|||Number
1438655|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization|"The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.|||participants|||Number
1438656|NCT00944710|Secondary|Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization|"The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome.~The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis."|10 weeks after randomization|The analysis includes data from participants who completed a 10-week exam.|||participants|||Number
1438673|NCT00944125|Primary|Change in Left Ventricular End Systolic Volume (LVESV)|The change in LVESV during the single and dual site LV pacing phases from baseline will be compared. The baseline for the second phase of the cross-over will be the end of phase one rather than the baseline done at time of randomization. Thus, the study will compare the incremental (or decremental) benefit of the alternate LV pacing configuration in each patient.|At 6 months to one year|Analysis population was based on the two randomized groups per the protocol.|||ml||Standard Deviation|Mean
1438657|NCT00944710|Primary|Distribution of 10-week Amblyopic-Eye Visual Acuity|"The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data.~The primary outcome analysis followed the intent-to-treat principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis."|10 weeks after randomization|The primary outcome analysis followed the intent-to-treat principle and included data from 10-week visual acuity exams completed between 8 and 15 weeks (inclusive) with no imputation for missing data.|||participants|||Number
1438658|NCT00944697|Primary|Short Form McGill Pain Score.|The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B – rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain.|Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)||||units on a scale||Standard Deviation|Mean
1438659|NCT00944671|Secondary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng/mL||95% Confidence Interval|Geometric Mean
1438660|NCT00944671|Secondary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng*h/mL||95% Confidence Interval|Geometric Mean
1438661|NCT00944671|Primary|Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng/mL||95% Confidence Interval|Geometric Mean
1438662|NCT00944671|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water||Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)||||ng*hr/mL||95% Confidence Interval|Geometric Mean
1438663|NCT00944645|Primary|Maximum Concentration (Cmax) of Laropiprant|Measure of rate of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant Cmax and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet.|||micro Molar||Standard Deviation|Median
1438664|NCT00944645|Primary|Area Under Curve (AUC 0-infinity) of Laropiprant|Measure of extent of absorption of laropiprant|Predose and up to 48 hours postdose|A linear mixed effect model was used to analyze laropiprant AUC0-infinity and uses data available from at least one treatment period. 166 subjects had data from the treatment of MK0524A New Site Tablet, and 167 subjects had data from the treatment of MK0524A Phase III Tablet|||Micro Molar times Hour||Standard Deviation|Median
1438665|NCT00944645|Primary|Total Amount of Urinary Excretion of Niacin and Its Metabolites|Measure of extent of absorption of ER niacin|Predose and up to 96 hours postdose|A linear mixed effect model was used to analyze total amount of urinary excretion of niacin and its metabolite and uses data available from at least one treatment period. 157 subjects had data from the treatment of MK0524A New Site Tablet, and 161 subjects had data from the treatment of MK0524A Phase III Tablet|||micro mole||Standard Deviation|Median
1438666|NCT00944645|Primary|Maximum Plasma Concentration (Cmax) of Nicotinuric Acid|Measure of rate of absorption of ER niacin|Predose and up to 24 hours postdose|The Hodges-Lehmann estimator was used to analyze nicotinuric acid Cmax and uses only subjects with data available on both treatment periods. 188 subjects were randomized,17 subjects discontinued, 26 subjects were inadvertently overdosed with 5 tablets of MK0524A 1000 mg/20 mg, reducing the available subject population for analysis to 145.|||ng/mL||Inter-Quartile Range|Median
1438667|NCT00944554|Primary|Days to Relapse|Number of days following the programmed lapse exposure until relapse to smoking occurred|4 weeks||||days||Standard Deviation|Mean
1438668|NCT00944450|Primary|Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects|||μmol/L||Standard Deviation|Geometric Mean
1438669|NCT00944450|Primary|Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)|Through 72 Hours Following the Administration of the Medication|Healthy Male and Female Subjects|||μmol*hr/L||Standard Deviation|Geometric Mean
1438670|NCT00944229|Primary|Change in Base Line Oxidized Low Density Lipoprotein (LDL) Level and in Response to Exercise||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.||||||
1438671|NCT00944229|Primary|Change in Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) After 8 Weeks of Omega 3 Supplementation.||0 and after 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.||||||
1438672|NCT00944229|Primary|Change in Peak VO2||0, 1 and 8 weeks of Omega 3 supplementation.|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2013.||||||
1438674|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438675|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438676|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438677|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438678|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438679|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438680|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|All participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438707|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438681|NCT00944073|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438682|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. One participant is excluded due to vaccine administration error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438683|NCT00944073|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438684|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 8-10 and 21 after first vaccination|All participants with blood collected at the timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438685|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438686|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438687|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.|||Participants|||Number
1438688|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|All participants with blood collected at both timepoints are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439123|NCT00942890|Primary|Lower Extremity Mobility-Chair Rise|Mobility was measured by the number of stands during the 30-second chair rise test.|6, 12 wks||||Number of stands||Standard Deviation|Mean
1438689|NCT00944073|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination|All participants with blood collected at baseline and with at least one evaluable time point after vaccination are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438690|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|All participants with blood collected at the timepoint within 7 days of the visit window are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438691|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438692|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438693|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21|Participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum. One participant was excluded due to the Day 21 blood draw being greater than 7 days out of window.|||Participants|||Number
1438694|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438695|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0|Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0|All participants with blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438696|NCT00944073|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438697|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439124|NCT00942890|Primary|Lower Extremity Mobility- Stair Climb|Mobility was measured by the time to complete a timed stair climb.|6, 12 wks||||Seconds||Standard Deviation|Mean
1438698|NCT00944073|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1438699|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1438700|NCT00944073|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1438701|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1438702|NCT00944073|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1438703|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438704|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438705|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants who received the second vaccination and had blood collected at the timepoint both within 7 days of the window are included. Two are excluded due to receipt of non-study vaccines, two due to vaccine administration errors and 1 due to a sample labeling error. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438706|NCT00944073|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine|Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|All participants who received the second vaccination within 7 days of the visit window and had blood collected at the timepoint are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439125|NCT00942890|Primary|Lower Extremity Mobility- Up and Go|"Mobility was measured by the time to complete an up and go test."|6, 12 wks||||Seconds||Standard Deviation|Mean
1438708|NCT00944073|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438709|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438710|NCT00944073|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438711|NCT00944047|Primary|Pathologic Complete Response||22 weeks||||percentage of participants|||Number
1438712|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|day 1 to day 7 after vaccination|The analysis was done on safety population|||participants|||Number
1438713|NCT00944034|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.|The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the Safety Population.|||participants|||Number
1438714|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA|1 month after booster vaccination|The analysis was performed on the per-protocol population|||IU/mL||95% Confidence Interval|Geometric Mean
1438715|NCT00944034|Secondary|Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.|Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.|1 month after booster vaccination|The analysis was performed on the per-protocol population|||IU/mL||95% Confidence Interval|Geometric Mean
1438716|NCT00944034|Secondary|Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months|Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after second vaccination|The analysis was performed on the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1438717|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)|||Titers||95% Confidence Interval|Geometric Mean
1438718|NCT00944034|Secondary|GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age|Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1438730|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-14).||Fourteen consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.|||hours/day||Standard Deviation|Mean
1439126|NCT00942890|Primary|Lower Extremity Mobility-Distance|Mobility was measured by the distance walked in 2 minutes.|6, 12 wks||||inches||Standard Deviation|Mean
1438719|NCT00944034|Secondary|Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.|The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.|1 month after booster|The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)|||Titers||95% Confidence Interval|Geometric Mean
1438720|NCT00944034|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.|1 month after booster|The analysis was performed on the per-protocol population|||percentage of subjects||95% Confidence Interval|Number
1438721|NCT00944034|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.|Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.|1 month after booster|The analysis was performed on per-protocol population. This outcome measure was assessed only against H44/76, NZ98/254 and 5/99 strains. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.|||percentage of subjects||98.3% Confidence Interval|Number
1438722|NCT00944034|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.|Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.|1 month after booster|The analysis was performed on the per-protocol population. This outcome measure was assessed only for the strains H44/76, NZ98/254 and 5/99. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.|||percentage of subjects||98.3% Confidence Interval|Number
1438723|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24 and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||hour||Standard Deviation|Mean
1438724|NCT00944021|Secondary|Pharmacokinetics-Maximum Observed Plasma Concentration (Cmax) (Day 14).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12,16, 24, and 30 hours post-dose on Day 14 of 14 consecutive days of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||ng/mL||Standard Deviation|Mean
1438725|NCT00944021|Secondary|Pharmacokinetics- Terminal Elimination Phase Half-life (t1/2) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||hours||Standard Deviation|Mean
1438726|NCT00944021|Secondary|Pharmacokinetics- Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC 0 to Infinity) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||ng * hour/mL||Standard Deviation|Mean
1438727|NCT00944021|Secondary|Pharmacokinetics- Maximum Observed Plasma Concentration (Cmax) (Day 1).||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, and 24 hours post-dose on Day 1 of treatment|All PA-824 patients who received at least one administration of the investigational drug, had at least one measured concentration after the start of treatment for at least one PK analysis and had no major events affecting the integrity of the PK data.|||ng/mL||Standard Deviation|Mean
1438728|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.|||hours/day||Standard Deviation|Mean
1438729|NCT00944021|Secondary|Rate of Change in Increased Time to Sputum Culture Positivity (TTP)(Hours) in Liquid Culture Media (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the TTP values could not be calculated due to missing results. The population is the number of patients for whom the results were available for this time period and therefore for whom the relevant TTP could be calculated.|||hours/day||Standard Deviation|Mean
1439127|NCT00942890|Primary|Lower Extremity Muscle Strength- Flexion|Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.|0, 3, 6, 9, 12 wks||||Kilograms||Standard Deviation|Mean
1438731|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 2-14).||Days 2-14 of 14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10CFU/ml/day||Standard Deviation|Mean
1438732|NCT00944021|Secondary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-2).||Two consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10CFU/ml/day||Standard Deviation|Mean
1438733|NCT00944021|Primary|Early Bactericidal Activity (EBA) Measured as the Mean Rate of Reduction of log10 Colony Forming Units (CFU) of M. Tuberculosis Per ml Sputum on Solid Medium Over Time (Days 0-14).||14 consecutive days of treatment|All randomized subjects. Some of the EBA values could not be calculated due to missing results. The analysis population is the number of patients for whom the results were available for this time period and therefore for whom the relevant EBA could be calculated.|||log10CFU/ml/day||Standard Deviation|Mean
1438734|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Intent to treat analysis|||percent change||Standard Deviation|Mean
1438735|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 48|Day 0 to Week 48|Per protocol - Only subjects with values at baseline and Week 48 endpoint are included.|||percent change||Standard Deviation|Mean
1438736|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Intent to treat analysis|||percent change||Standard Deviation|Mean
1438737|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c through Week 24|Day 0 to Week 24|Per protocol analysis - Only subjects with values at baseline and Week 24 endpoint are included.|||percent change||Standard Deviation|Mean
1438738|NCT00943917|Primary|Mean Change in HbA1c (ITT)|Mean change in HbA1c through Week 12|Day 0 to Week 12|Intent to treat analysis|||percent change||Standard Deviation|Mean
1438739|NCT00943917|Primary|Mean Change in HbA1c (Per Protocol)|Mean change in HbA1c over first 12 weeks (Stage I)|Day 0 and Week 12|Per protocol analysis- Only subjects with values at baseline and Week 12 endpoint are included.|||percent change||Standard Deviation|Mean
1438740|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.|||Participants|||Number
1438741|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.|||Participants|||Number
1438742|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.|||Participants|||Number
1438743|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
1438744|NCT00943878|Primary|Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
1438745|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.|Within 8 days (Day 0-7) post second placebo vaccination|Participants who received the second placebo vaccination are included. Analyses are as treated.|||Participants|||Number
1439128|NCT00942890|Primary|Lower Extremity Muscle Strength- Extension|Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.|0, 3, 6, 9, 12 wks||||Kilograms||Standard Deviation|Mean
1438746|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.|Within 8 days (Day 0-7) post first placebo vaccination|Participants who received the first placebo vaccination are included. Analyses are as treated.|||Participants|||Number
1438747|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|Participants who received the TIV vaccination are included. Analyses are as treated.|||Participants|||Number
1438748|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|Participants who received the second H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
1438749|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|Participants who received the first H1N1 vaccination are included. Analyses are as treated.|||Participants|||Number
1438750|NCT00943878|Primary|Number of Participants Reporting Fever After the Third Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
1438751|NCT00943878|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
1438752|NCT00943878|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.|||Participants|||Number
1438753|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post third vaccination|Participants who received the third vaccination are included. Analyses are as treated.|||Participants|||Number
1438754|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|Participants who received the second vaccination are included. Analyses are as treated.|||Participants|||Number
1438755|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438778|NCT00943787|Secondary|Maximum Epinephrine Response (ADRR Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.~Average Daily Risk Range (ADRR) is associated with glycemic variability and risk of both hyper- and hypoglycemia.~Low Risk, ADRR < 20; Moderate Risk, 20 < ADRR < 40; and High Risk,ADRR > 40."|285 min (time of clamp)|3 participants did not have enough epinephrine data|||pg/ml||Standard Deviation|Mean
1438756|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438757|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438758|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.|Day 63|Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438759|NCT00943878|Primary|Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|Participants who received the first vaccination are included. Analyses are as treated.|||Participants|||Number
1438760|NCT00943878|Primary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438761|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438762|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.|Day 0 prior to vaccination and 21 days after the second H1N1 vaccination|Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438790|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438763|NCT00943878|Secondary|Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438764|NCT00943878|Secondary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.|Day 63|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438765|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438766|NCT00943878|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after the last vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1438767|NCT00943878|Primary|Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438768|NCT00943878|Primary|Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438769|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo|"The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P =~pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline."|Baseline and 10 hours postdose|All subjects who received single doses of Losartan 100 mg + ISMN 60 mg and/or single dose of placebo|||Percent Change||Standard Deviation|Least Squares Mean
1438791|NCT00943735|Secondary|Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438770|NCT00943852|Primary|Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg|The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.|Baseline and 10 hours postdose|All subjects who received single doses of losartan 100 mg + ISMN 60 mg and/or single dose of losartan 100 mg|||Percent Change||Standard Deviation|Least Squares Mean
1438771|NCT00943826|Secondary|Number of Participants With Non-Serious Adverse Events, Serious Adverse Events and Death|An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as AE.A serious adverse event (SAE) is any experience that suggests a significant hazard,contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Non-serious adverse events (Non-SAEs) included all AEs except SAEs (non-SAEs = all AEs – SAEs). Nine participants randomized to the Placebo+RT+Temozolomide arm incorrectly received at least 1 dose of bevacizumab and were added to the Bevacizumab+RT+Temozolomide arm for Safety.|Randomization until study completion (Until data cutoff= 09 Sep 2015 [up to 64 months])|Safety Population included all randomized participants who received study treatment during the treatment period (10 participants did not receive at least one dose of study treatment and were therefore excluded, 4 in Placebo and 6 in Bevacizumab.|||Participants|||Number
1438772|NCT00943826|Secondary|PFS in Participants With Stable/Improved Health Related Quality of Life (HRQoL) Based on European Organization for Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30)(EORTC QLQ-C30) & EORTC QLQ Brain Neoplasm 20 (BN20)|EORTC QLQ-C30: 30 items; 5 functional scales; 9 symptom scales; & global health status. Most questions used 4-point scale (1:Not at all, 4:Very much), 2 questions used 7-point scale (1:very poor, 7:Excellent). EORTC QLQ-BN20: 20 items rated on a 4 point scale (1:not at all, 4:very much). EORTC QLQ-C30 and BN20 scores were transformed to a 0-100 scale, higher score=better functioning/global health (C30) or more severe symptoms (BN20). Stable HRQoL: change from baseline (BL) within 10 points. Improved HRQoL: an increase from BL >/=10 points for functioning/global health status, & decrease of >/=10 points for symptoms. PFS is reported for participants with Stable/Improved global health; physical, social functioning (C30); motor dysfunction & communication deficit (BN20). PFS: randomization to PD or death. PD: >=25% increase in sum of products of longest diameters of index lesions; or progression of existing non-index lesions; or appearance of new lesions; or neurological worsening.|Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)|Intent to treat population. Number of Participants Analyzed = overall participants evaluable for this outcome measure; n = participants evaluable for specified category.|||Months||Full Range|Median
1438773|NCT00943826|Secondary|Kaplan-Meier (KM) Estimate of Two Year Overall Survival|KM estimate of two year overall survival was reported (probability to survive for at least 2 years). Corresponding 95% CI was calculated using Greenwood’s formula.|Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.|||probability of being alive||95% Confidence Interval|Number
1438774|NCT00943826|Secondary|Kaplan-Meier (KM) Estimate of One Year Overall Survival|KM estimate of one year overall survival (probability to survive for at least 1 year) was reported. Corresponding 95% confidence interval (CI) was calculated using Greenwood's formula.|Randomization until Overall Survival Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.|||probability of being alive||95% Confidence Interval|Number
1438775|NCT00943826|Secondary|PFS as Assessed by an Independent Review Facility|An Independent Review Facility reviewed the MRI scans used by investigator to evaluate radiological tumor response. PFS is defined as time from randomization to PD or death. PD was assessed using adapted Macdonald response (modified WHO) criteria based on 3 components: radiological tumor assessments using MRI scans, neurological assessment and changes in corticosteroid use. PD is assessed as >=25% increase in sum of products of the longest diameters of all index lesions (enhancing, measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing, non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.|Randomization until PFS Event (Until data cutoff= 31 March 2012 [up to 29.5 months])|Intent to treat population.|||Months||95% Confidence Interval|Median
1438776|NCT00943826|Primary|Co-Primary: Overall Survival (OS)|Overall Survival was defined as the time from randomization to death due to any cause.|Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months])|Intent to treat population.|||Months||95% Confidence Interval|Median
1438777|NCT00943826|Primary|Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator|PFS is defined as time from randomization to disease progression (PD) or death. PD was assessed using adapted Macdonald response criteria (modified World Health Organization [WHO] criteria) based on 3 components: radiological tumor assessments using Magnetic Resonance Imaging [MRI] scans,neurological assessment and changes in corticosteroid use. PD is assessed as greater than or equal to(>=) 25% increase in sum of products of the longest diameters of all index lesions (enhancing,measurable) compared with the smallest recorded sum (nadir); or unequivocal PD of existing non-index lesions (non-enhancing and enhancing,non-measurable); or unequivocal appearance of new lesions); or neurological worsening (if corticosteroid dose is stable or increased) compared to neurological evaluation at previous disease assessment with no need for a confirmatory scan. Participants without a PFS event were censored at last disease assessment.|Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)|Intent to treat population.|||Months||95% Confidence Interval|Median
1439158|NCT00942266|Secondary|Toxicity|"Number of participants with an adverse event.~Please refer to the adverse event reporting for more detail."|Daily|All treated and eligible patients; per protocol|||participants|||Number
1438779|NCT00943787|Primary|Maximum Epinephrine Response (LBGI Groups)|"Mean maximum epinephrine response during induced hypoglycemia is the average of subjects' maximum concentration of all epinephrine measurements taken at plasma glucose level lower than 70mg/dL.~Low blood glucose index (LBGI) is a metric to calculate the risk for hypoglycemia based on frequency and extent of past events based on SMBG readings. In studies, the LBGI typically accounted for 40–55% of the variance of future significant hypoglycemia in the subsequent 3–6 months. The LBGI has established risk categories: Low Risk, LBGI < 2.5; Moderate Risk, 2.5 < LBGI < 5; and High Risk, LBGI > 5, indicating an over 10-fold increase in future severe hypoglycemia from the lowest to the highest risk category."|285 min (time of clamp)|3 participants did not have adequate epinephrine data.|||pg/ml||Standard Deviation|Mean
1438780|NCT00943761|Primary|Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)|SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.|72 weeks|Population includes only a subset of participants previously treated with placebo + peg-IFN + RBV in a vaniprevir study and excludes participants for failure to receive >=1 dose of study drug, lack of any post-allocation endpoint data subsequent to >=1 dose of study drug, lack of baseline data, or missing data due to discontinuation from the study|||Percentage of participants||95% Confidence Interval|Number
1438781|NCT00943761|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|48 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.|||Participants|||Number
1438782|NCT00943761|Primary|Number of Participants Who Experienced a Serious Adverse Event|Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.|||Participants|||Number
1438783|NCT00943761|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|up to 72 weeks|All participants as treated population consists of all participants who received at least one dose of study treatment.|||Participants|||Number
1438784|NCT00943735|Secondary|Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview||Enrollment (Day 0) up to 90 days|PP population; (n)=CATI response valid n at observation. Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid n, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438785|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438786|NCT00943735|Secondary|Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438787|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With Their Physician||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438788|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers|"Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438789|NCT00943735|Secondary|Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438792|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438793|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors|The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438794|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Learned Something About Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438795|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)|Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438796|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438797|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438798|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice|YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks. The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438799|NCT00943735|Secondary|Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438800|NCT00943735|Secondary|Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438801|NCT00943735|Secondary|Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan|Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit. Follow-up visits could be scheduled per standard clinical practice.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438802|NCT00943735|Secondary|Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary|"For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to this week I did well at, and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438803|NCT00943735|Secondary|Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker|"YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to wait), daily Toviaz® (always take as directed), and keep track (share with your doctor)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438804|NCT00943735|Secondary|Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438805|NCT00943735|Secondary|"Percentage of Participants Who Reported That They Trained Their Bladder to Wait"|"The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating I'm the boss - not my bladder)."|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438806|NCT00943735|Secondary|Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices|The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438807|NCT00943735|Secondary|Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms|The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438808|NCT00943735|Secondary|Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit|YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form. About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for “Core 4” elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and “track your progress” brochure; and recipes using bladder-friendly foods.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438809|NCT00943735|Secondary|Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful||Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438810|NCT00943735|Secondary|Percentage of Participants Who Visited the YourWay Website|YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component. Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants’ Overactive Bladder (OAB) outcomes. Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement.|Baseline up to 90 days|PP population; N=CATI response valid N: Participants’ interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.|||percentage of participants||95% Confidence Interval|Number
1438811|NCT00943735|Secondary|Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice. The first refill indicated that 2 fesoterodine prescriptions had been filled.|Enrollment (Day 0) up to 90 days|PP population|||percentage of participants||95% Confidence Interval|Number
1438812|NCT00943735|Secondary|Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)|The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period. Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.|Enrollment (Day 0) up to 90 days|PP population|||percentage of participants||95% Confidence Interval|Number
1438813|NCT00943735|Primary|Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment|Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.|Enrollment (Day 0) up to 90 days|Per Protocol (PP) population: all participants who returned a signed informed consent form (Intent to Treat) and enrollment questionnaire, had evidence of ≥1 prescription in LRx database for any medication class, and did not receive an initial fesoterodine prescription for ≥ a 90-day supply.|||percentage of participants||95% Confidence Interval|Number
1438814|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post- vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||Percentage of Participants||95% Confidence Interval|Number
1438815|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||Percentage of Participants||95% Confidence Interval|Number
1438816|NCT00943722|Secondary|Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||Percentage of Participants||95% Confidence Interval|Number
1438817|NCT00943722|Primary|Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)|Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.|||Percentage of Participants|||Number
1438818|NCT00943722|Primary|Percentage of Participants With Systemic AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.|up to 15 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.|||Percentage of Participants|||Number
1438819|NCT00943722|Primary|Percentage of Participants With Injection Site Adverse Experiences (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.|up to 5 days after any vaccination|All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Data from 9- to 15-year-old females were pooled regardless of lot administered.|||Percentage of Participants|||Number
1438831|NCT00943670|Secondary|Number of Participants With Decreased Ejection Fraction|"Left ventricular ejection fraction (LVEF) was assessed on the basis of local assessments of echocardiogram or multigated acquisition scan (MUGA) data. A decrease in LVEF is defined as a decrease from Baseline of greater than or equal to 15%.~Grade 3 LVEF is an ejection fraction between 20 and 40%."|Assessed at Baseline and after every 3 cycles, up to 1 year.|Safety-Evaluable Patients (i.e., the treated population).|||participants|||Number
1438820|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
1438821|NCT00943722|Primary|GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
1438822|NCT00943722|Primary|Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])|Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.|4 weeks post-vaccination 3 (Month 7)|9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
1438823|NCT00943683|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|During the 6 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
1438824|NCT00943670|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATAs) to Trastuzumab Emtansine|The number of participants with anti-T-DM1 antibodies was assessed using a validated bridging antibody enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|Evaluable patients, defined as patients who had at least one ATA measurement available for analysis at Baseline (pre-dose in Cycle 1) and post-baseline.|||participants|||Number
1438825|NCT00943670|Secondary|Volume of Distribution at Steady State for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||mL/kg||Standard Deviation|Mean
1438826|NCT00943670|Secondary|Clearance T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||mL/day/kg||Standard Deviation|Mean
1438827|NCT00943670|Secondary|Terminal Half-life for T-DM1 and Total Trastuzumab||Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||days||Standard Deviation|Mean
1438828|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero extrapolated to infinity (AUCinf) for T-DM1 (conjugated trastuzumab) and total trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycle 1.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||μg * day/mL||Standard Deviation|Mean
1438829|NCT00943670|Secondary|Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration for T-DM1 and Total Trastuzumab|Area under the serum concentration−time curve from Time zero to time of last measurable concentration (AUClast) for T-DM1 (conjugated trastuzumab) and Total Trastuzumab (conjugated and unconjugated T-DM1) at Cycle 1 and Cycle 3.|Blood samples were collected prior to T-DM1 dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"PK-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||μg * day/mL||Standard Deviation|Mean
1438830|NCT00943670|Secondary|Maximum Observed Serum Concentration of T-DM1 and Total Trastuzumab|Serum samples were quantitated for T-DM1 (DM1 conjugated to trastuzumab) levels in a validated assay using an indirect sandwich enzyme-linked immunosorbent assay (ELISA). The minimum quantifiable concentration in human serum was 40 ng/mL. Serum samples were assayed for total trastuzumab (conjugated and unconjugated T-DM1) in a validated assay using an indirect sandwich ELISA method; the minimum quantifiable concentration in human serum was 40 ng/mL.|Blood samples were collected prior to dosing, 15 and 60 minutes after the end of infusion, and anytime on Days 8 and 15 in Cycles 1 and 3, and pre-dose in Cycle 4.|"Pharmacokinetic (PK)-evaluable patients were defined as patients who had adequate concentration−time data to estimate at least one PK parameter. N refers to the number of PK-evaluable patients in that cycle."|||μg/mL||Standard Deviation|Mean
1438832|NCT00943670|Secondary|Number of Participants With Adverse Events (AEs)|"An serious AE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product(s), or is considered a significant medical event by the investigator (e.g., may jeopardize the patient or may require medical/surgical intervention to prevent one of the outcomes listed above).~The severity of each AE was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0, or as follows: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Very severe; Grade 5 = Death related to AE."|From first dose until 30 days after last dose (up to 1 year).|Safety-Evaluable Patients (i.e., the treated population).|||participants|||Number
1438833|NCT00943670|Secondary|Percentage of Participants With Clinical Benefit During the Single-agent Trastuzumab Emtansine Treatment Period|"Participants were considered to have experienced clinical benefit if they had an objective response or maintained stable disease for at least 6 months from start of study treatment. Objective response was defined as a complete or partial response determined on two consecutive tumor assessments at least 4 weeks apart based on a modified version of RECIST.~Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started and no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1438834|NCT00943670|Secondary|Progression-free Survival During the Single-agent Trastuzumab Emtansine Treatment Period|Progression-free survival (PFS) was defined as the time from the first day of study treatment (Day 1) to first documented disease progression or death, whichever occurred first. If a patient did not experience disease progression or die, PFS was censored at the day of the last tumor assessment that a patient was known to be progression free.|From the first day of study treatment to the first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients.|||months||95% Confidence Interval|Median
1438835|NCT00943670|Secondary|Duration of Objective Response Based on Investigator Assessment During the Single-agent Trastuzumab Emtansine Treatment Period|"In patients with an objective response during the single-agent trastuzumab emtansine treatment period, duration of response was defined as the time from the first documented objective response to the time of first documented disease progression or death, whichever occurred first. Progressive disease was defined as either at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with an absolute increase of at least 5 mm, or the appearance of one or more new lesions, or the unequivocal progression of existing nontarget lesions.~If a patient did not die or experience disease progression before the end of the study, duration of response was censored at the day of the last tumor assessment when the patient was known to be progression free."|Time from the first documented objective response to the time of first documented disease progression or death, up to a maximum time period of one year.|Efficacy evaluable patients who achieved an objective response.|||months||95% Confidence Interval|Median
1438836|NCT00943670|Secondary|Percentage of Participants With an Objective Response During the Single-agent Trastuzumab Emtansine Treatment Period|"Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments conducted by the investigator ≥ 4 weeks apart. Responses were assessed by physical examination and imaged-based evaluation using a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0:~CR—the disappearance of all target lesions and the disappearance of all nontarget lesions and normalization of tumor marker level and no new lesions.~PR—either the disappearance of all target lesions with persistence of one or more nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter with no new lesions or unequivocal progression of existing nontarget lesions."|Tumor assessments were performed after every three cycles until study termination or progressive disease (up to a maximum of one year).|The efficacy-evaluable population was defined as patients who received at least one dose of study drug. Patients with missing or no post-baseline response assessments were classified as non-responders.|||percentage of participants||95% Confidence Interval|Number
1438837|NCT00943670|Secondary|Percentage of Participants With New Abnormal T Waves|The incidence of abnormal T-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable. C=Cycle; D=Day.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
1438838|NCT00943670|Secondary|Percentage of Participants With New Abnormal U Waves|The incidence of abnormal U-wave changes from baseline was determined based on centrally read electrocardiogram (ECG) tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
1438880|NCT00943592|Primary|Number of Participants With Hepatic Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
1438839|NCT00943670|Secondary|Percentage of Participants Within Each Baseline-adjusted QTc Interval Category|"The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTc interval was subtracted from the average QTc intervals to create a baseline-adjusted average QTc interval.~QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14."|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
1438840|NCT00943670|Secondary|Percentage of Participants Within Each Absolute QTc Interval Category|The corrected QT interval was calculated using Fridericia's correction (QTcF) and using Bazett's correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTc intervals measured at each timepoint and the average was calculated for each patient at each timepoint. QTc interval categories are based off International Conference on Harmonisation (ICH) Tripartite Guideline E14.|Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|The number of participants analyzed for each QTc interval category represents the total treated population. N indicates the ECG−evaluable population with available data at each time point.|||percentage of participants|||Number
1438841|NCT00943670|Secondary|Change From Baseline in Heart Rate||Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||beats per minute||Standard Deviation|Mean
1438842|NCT00943670|Secondary|Change From Baseline in QRS Duration|The QRS interval represents the time it takes for depolarization of the ventricles and was calculated from electrocardiogram (ECG) data. Each participant had triplicate QRS intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QRS interval was subtracted from the average QRS intervals to create a baseline-adjusted average QRS interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||milliseconds||Standard Deviation|Mean
1438843|NCT00943670|Secondary|Change From Baseline in PR Interval|The PR interval is the time in seconds from the beginning of the P wave to the beginning of the QRS complex, and was calculated from electrocardiogram (ECG) data. Each participant had triplicate PR intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline PR interval was subtracted from the average PR intervals to create a baseline-adjusted average PR interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG-Evaluable population|||milliseconds||Standard Deviation|Mean
1438844|NCT00943670|Secondary|Change From Baseline in Uncorrected QT Interval|The uncorrected QT interval was calculated from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QT interval was subtracted from the average QT intervals to create a baseline-adjusted average QT interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||milliseconds||Standard Deviation|Mean
1438845|NCT00943670|Secondary|Change From Baseline in Mean Duration of the QTc Interval Using Bazett’s Correction|The corrected QT interval was calculated using Bazett’s correction (QTcB) from electrocardiogram (ECG) data. Each participant had triplicate QTcB intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant's corresponding baseline QTcB interval was subtracted from the average QTcB intervals to create a baseline-adjusted average QTcB interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−Evaluable population; N indicates the ECG−evaluable population with available data at each time point.|||milliseconds||Standard Deviation|Mean
1438846|NCT00943670|Primary|Change From Baseline in Mean Duration of the QTc Interval|The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The corrected QT interval was calculated using Fridericia’s correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QTcF intervals measured at each timepoint and the average was calculated for each patient at each timepoint. For each timepoint, a participant’s corresponding baseline QTcF interval was subtracted from the average QTcF intervals to create a baseline-adjusted average QTcF interval.|Cycle 1 Day 1, pre-dose (Baseline); Cycle 1 Day 1, 15 and 60 minutes post-dose; Cycle 1 Day 8; and Cycle 3 Day 1, 15 minutes pre-dose and 15 and 60 minutes post-dose.|ECG−evaluable population consisted of patients who received T-DM1, had at least 1 interpretable pre−T-DM1 ECG measurement recorded on Cycle 1 Day 1, had at least 1 interpretable post−T-DM1 ECG measurement and who were not treated with medications that may have altered cardiac conduction. N indicates the ECG−evaluable population at each time point.|||milliseconds||Standard Deviation|Mean
1438847|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.|||Participants|||Number
1438848|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of an non-study vaccine prior to the clinic visit.|||Participants|||Number
1438849|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.|||Participants|||Number
1438850|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438851|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438852|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants at Day 8-10 and Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438853|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.|||Participants|||Number
1438854|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438881|NCT00943579|Secondary|Adverse Events Reporting|This is not a standardized measure but instead a set of questions, both closed and open ended, asked of families about their child's response to the medication. Used for determining whether treatment needed to be discontinued.|Cummulative throughout study|Data were not specifically analyzed but used instead to determine whether treatment needed to be discontinued. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
1439351|NCT00940017|Primary|Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL). Observed directly from the data. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
1438855|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to the blood being collected after administration of the second vaccination.|||Participants|||Number
1438856|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438857|NCT00943631|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438858|NCT00943631|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438859|NCT00943631|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
1438860|NCT00943631|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
1438861|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
1438862|NCT00943631|Primary|Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
1438863|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
1438905|NCT00943488|Primary|Number of Participants Reporting Fever After the First Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
1438864|NCT00943631|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One subject was excluded due to receipt of a non-study vaccine prior to the clinic visit.|||Participants|||Number
1438865|NCT00943631|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine|Blood was collected from all participants prior to the initial vaccination as well as 8-10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Baseline and Day 8-10 and 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations and had blood collected at the timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438866|NCT00943631|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
1438867|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort.|||Participants|||Number
1438868|NCT00943631|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort.|||Participants|||Number
1438869|NCT00943631|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination||||Participants|||Number
1438870|NCT00943605|Secondary|Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1438871|NCT00943605|Primary|Area of Skin Necrosis Measured With a Standard Ruler||1 and 6 weeks postoperative|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1438872|NCT00943605|Primary|Total Serous Drainage (mL) From Time of Drain Placement to Removal.||0 to 10 days postoperatively|An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.||||||
1438873|NCT00943592|Secondary|Relapse Rate||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
1438874|NCT00943592|Secondary|Treatment-related Mortality (TRM)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
1438875|NCT00943592|Secondary|Progression-free Survival (PFS)|Progression is defined from stem cell infusion to disease relapse, i.e., recurrence of hematologic malignancy and/or need for treatment after transplant for disease or death from any cause, whichever occurred first.|1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
1438876|NCT00943592|Primary|Number of Participants With Other Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
1438877|NCT00943592|Primary|Number of Participants With Skin Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
1438878|NCT00943592|Primary|Number of Participants With Renal Adverse Events During the Conditioning Regimen Prior to Stem Cell Transplantation|Toxicity was scored according to NCI/CTC version 3|Day 7 until Day 30||||participants|||Number
1438879|NCT00943592|Secondary|Overall Survival (OS)||1 year|74 patients received the Maximum Tolerated Dose of clofarabine 40 mg/m2 IV daily x 5 days, melphalan 140 mg/m2 x 1 day, and alemtuzumab 20 mg IV daily x 5 days|||percentage of participants||95% Confidence Interval|Number
1438882|NCT00943579|Secondary|Aberrant Behavior Checklist (ABC)|This is a 58-item informant-based, factor-analyzed scale comprised of a total scale and 5 subscales that generate raw scores. Scores based on a likert scale ranging from 0-3 where 0 is not a problem to 3 where the problem is severe. Subscales include: Irritability, Social Withdrawal, Stereotypic Behaviors, Hyperactivity and Inappropriate Speech. Total maximum score is 174. Higher subscale scores indicate more symptoms. Scores are totaled to compute subscale scores. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|all participants who completed the open label extension were analyzed.|||units on a scale||Standard Error|Mean
1438883|NCT00943579|Secondary|Connor’s Preschool ADHD Questionnaire|This is a measure of behavioral symptomatology in children 2-6 years of age. The ADHD scale is one subdomain.|Weeks 8 & 16|Data was not analyzed secondary to lack of significant findings in primary outcome measure and reduced number of completed questionnaires. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
1438884|NCT00943579|Secondary|Preschool Language Scale, 4th Edition (PLS-4)|Measures expressive & receptive language and total scores in ages 0 to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher raw scores indicate better language skills. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. We used random intercept & trend modeling that accounts for each individual's initial level of symptom severity/functioning & rate of change/time|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants completed the open label extension were analyzed in the study.|||units on a scale||Standard Error|Mean
1438885|NCT00943579|Secondary|Parental Global Assessment|this is a measure of parents impression of improvement.|Weeks 8 & 16|the data were not analyzed secondary to lack of findings in primary outcome measure as well as the nature of an open label study. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
1438886|NCT00943579|Secondary|Children’s Yale Brown Obsessive Compulsive Scale|The C-YBOCS is a scale is designed to rate the severity of obsessive and compulsive symptoms in children and adolescents, ages 6 to 17 years. It can be administered by a clinican or trained interviewer in a semi-structured fashion. In general, the ratings depend on the child's and parent's report; however, the final rating is based on the clinical judgement of the interviewer. Rate the characteristics of each item over the prior week up until, and including, the time of the interview. Scores should reflect the average of each item for the entire week, unless otherwise specified.|Weeks 8 & 16|The data was not analyzed secondary to lack of significant findings in primary outcome measures and limited data collected on this measure. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
1438887|NCT00943579|Secondary|Vineland Adaptive Behavior Scale, 2nd Edition|The Vineland-2 is semi-structured interview designed to communication, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite Scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. The scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in this study. Higher subscale scores indicate more skills. Raw scores can range from 0 to 766 for the overall adaptive behavior composite. Subscales are combined to form the overall Adaptive Behavior Composite, which is essentially a weighted average of the various subscales combined.|Weeks baseline (week 16 from CHC-0901), 8 and 16. Primary outcome assessment looked at change between baseline (week 16 from CHC-0901 and week 16 of CHC-0902).|All participants who completed the open label extension were analyzed.|||units on a scale||Standard Error|Mean
1438888|NCT00943579|Primary|Clinical Global Impressions Scale|This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale (1) very much improved, (2) much improved, (3) minimally improved (4) no change, (5) minimally worse, (6) much worse and (7) very much worse. Chi-square analyses were used to assess change in CHI-I scores (by group, post-test)Mixed-effects regression models determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. The mixed-effects models accounted for each participant's outcome data at each time point. The mixed-effects regression model is robust to data dependency that occurs with the repeated assessments of individuals over time & can handle missing data. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|16 weeks|The number of participants analyzed included those who completed the open label extension of this study.|||# participants much - very much improved|||Number
1438889|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and four due to receiving non-study vaccines prior to the visit.|||Participants|||Number
1438890|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.|||Participants|||Number
1438891|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.|||Participants|||Number
1438892|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438893|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and four due to receiving non-study vaccines prior to the visit.|||Participants|||Number
1438894|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 21 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to receiving a non-study vaccine prior to the visit.|||Participants|||Number
1438895|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two due to receiving non-study vaccines prior to the visit.|||Participants|||Number
1438896|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1439170|NCT00942175|Primary|Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.|MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK and PD statistical analyses for those parameters.|||percentage of MPA||Standard Deviation|Mean
1438897|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.|||Participants|||Number
1438898|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438899|NCT00943488|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through Day 180 after last vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
1438900|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated and restricted to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection, and two were excluded due to receiving non-study vaccines prior to the visit.|||Participants|||Number
1438901|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at the timepoint. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438902|NCT00943488|Primary|Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum. One participant was excluded due to presumed natural Influenza H1N1 infection prior to the Day 8-10 visit.|||Participants|||Number
1438903|NCT00943488|Primary|Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine|Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 0 prior to and Day 8-10 after first vaccination|Participants were included in the analyses if they received the first vaccination and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438904|NCT00943488|Primary|Number of Participants Reporting Fever After the Second Vaccination|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
1438916|NCT00943436|Primary|Percent Energy From Protein at the Meal (Rest Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
1438906|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
1438907|NCT00943488|Primary|Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
1438908|NCT00943488|Secondary|Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.|||Participants|||Number
1438909|NCT00943488|Secondary|Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.|Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.|Day 0 prior to first vaccination and Day 8-10 after the second vaccination|Participants were included in the analyses if they received both vaccinations, with the second vaccination given within 4 days of the window, and had blood collected at both timepoints. Participants were analyzed as treated. This outcome measure restricts to age stratum.|||Participants|||Number
1438910|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
1438911|NCT00943488|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
1438912|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after second vaccination|All participants receiving the second vaccination are included in the safety ITT cohort|||Participants|||Number
1438913|NCT00943488|Primary|Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination|Participants maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0-7 after first vaccination|All participants receiving the first vaccination are included in the safety ITT cohort|||Participants|||Number
1438914|NCT00943436|Primary|Percent Energy From Fat at the Meal (Rest Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
1438915|NCT00943436|Primary|Percent Energy From Fat at the Meal (Exercise Session)|Fat intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
1438917|NCT00943436|Primary|Percent Energy From Protein at the Meal (Exercise Session)|Protein intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
1438918|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Rest Session)|carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
1438919|NCT00943436|Primary|Percent Energy From Carbohydrate at the Meal (Exercise Session)|Carbohydrate intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||percentage of kilocalorie intake||Standard Deviation|Mean
1438920|NCT00943436|Primary|Energy Intake at the Meal (Rest Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||kilocalories||Standard Deviation|Mean
1438921|NCT00943436|Primary|Energy Intake at the Meal (Exercise Session)|Energy intake was measured by weighing each item served in the ad libitum buffet meal before and after the subject's meal and subtracting the difference to determine gram weight of each item consumed. Food labels and the NDS-R software were used to determine dietary intake based upon gram weight of each food consumed.|2 hours||||kilocalories||Standard Deviation|Mean
1438922|NCT00943397|Primary|Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 52 weeks of treatment|All patients who took study medication were included in the analysis.|||Participants|||Number
1438923|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). Percent change was calculated as [(Month 24 – Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
1438924|NCT00943384|Secondary|Short Form 12 (SF-12v2) Mental Component Summary (MCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70).|Month 24|Per protocol|||units on a scale||Standard Deviation|Mean
1438925|NCT00943384|Secondary|Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). Percent change was calculated as [(Month 24 – Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
1438926|NCT00943384|Secondary|Short Form 12 (SF-12v2) Physical Component Summary (PCS)|The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69).|Month 24|Per protocol|||units on a scale||Standard Deviation|Mean
1439049|NCT00943150|Primary|Inflammatory Cell Count|Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.|0, 3, and 6 weeks||||cells per square millimeter||Standard Deviation|Mean
1438927|NCT00943384|Secondary|Percent Change in Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
1438928|NCT00943384|Secondary|Leg Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Per protocol.|||units on a scale||Standard Deviation|Mean
1438929|NCT00943384|Secondary|Percent Change in Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Back pain was assessed in the per-protocol population. Of the 55 subjects who were evaluated at the Month 24 visit, two were missing data related to back pain.|||percent change||Standard Deviation|Mean
1438930|NCT00943384|Secondary|Back Pain on Visual Analog Scale|The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain.|Month 24|Of the 55 subjects who were evaluated at Month 24, two were missing back pain data.|||units on a scale||Standard Deviation|Mean
1438931|NCT00943384|Secondary|Percent Change in Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. Percent change in ODI score was calculated as: [(Month 24-Baseline)/Baseline]*100%.|Month 24|Per protocol|||percent change||Standard Deviation|Mean
1438932|NCT00943384|Secondary|Oswestry Disability Index (ODI)|The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function.|Month 24|Per protocol|||units on a scale||Standard Deviation|Mean
1438933|NCT00943384|Primary|Posterolateral Fusion Success|The primary outcome for posterolateral fusion status was a composite endpoint incorporating posterior bridging bone status, intersegmental motion (angular and translational motion) and posterior hardware status. To have successful posterolateral fusion, a subject had to be successful in all four components at all levels under investigation. Failure to meet any one of the four components indicated failed posterolateral fusion status.|Month 24|The primary endpoint was evaluated for the per-protocol population. Of the 55 patients who were evaluated at the Month 24 visit, six patients were missing complete radiographic data needed to evaluate the primary endpoint.|||participants|||Number
1438934|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438935|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438936|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438937|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438938|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438939|NCT00943306|Secondary|Percent Change in Apolipoprotein AI (Apo AI)|Percent change in Apolipoprotein AI (Apo AI) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438940|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438941|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438942|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438943|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438944|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438945|NCT00943306|Secondary|Percent Change in High Density Lipoprotein Cholesterol (HDL-C)|Percent change in High Density Lipoprotein Cholesterol (HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438946|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438947|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438948|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438949|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438950|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438951|NCT00943306|Secondary|Percent Change in Lp(a)|Percent change in Lp(a) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438952|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438953|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438954|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438955|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438956|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438957|NCT00943306|Secondary|Percent Change in Very Low Density Lipoprotein Cholesterol (VLDL-C)|Percent change in Very Low Density Lipoprotein Cholesterol (VLDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438958|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438959|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438960|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438961|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438962|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438963|NCT00943306|Secondary|Percent Change in Non High Density Lipoprotein Cholesterol (Non-HDL-C)|Percent change in Non High Density Lipoprotein Cholesterol (Non-HDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438964|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438965|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438966|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438967|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438968|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438969|NCT00943306|Secondary|Percent Change in Triglycerides|Percent change in Triglycerides from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438970|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438971|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438972|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438973|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438974|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438975|NCT00943306|Secondary|Percent Change in Apolipoprotein B (Apo B)|Percent change in Apolipoprotein B (Apo B) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438976|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438977|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1439188|NCT00941928|Secondary|Overall Survival (OS)|Number of surviving participants without disease progression or death for any reason at one year post treatment.|Minimum of 1 year, or until disease progression or death|||||||
1438978|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438979|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438980|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438981|NCT00943306|Secondary|Percent Change in Total Cholesterol|Percent change in Total Cholesterol from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438982|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 294 (Week 216 in Study AEGR-733-012).|Baseline and Week 294|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438983|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 270 (Week 192 in Study AEGR-733-012).|Baseline and Week 270|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438984|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 246 (Week 168 in Study AEGR-733-012).|Baseline and Week 246|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438985|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 222 (Week 144 in Study AEGR-733-012).|Baseline and Week 222|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438986|NCT00943306|Secondary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 174 (Week 96 in Study AEGR-733-012).|Baseline and Week 174|Safety Population – The number of patients in the Safety Population at time points after Week 126 decreased because the study remained active within each country until either approval of the marketing application was obtained, or, in countries where marketing authorization was not sought for, patients transitioned into an Expanded Access Program.|||Percent Change||Standard Deviation|Mean
1438987|NCT00943306|Primary|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C)|Percent Change in Low Density Lipoprotein Cholesterol (LDL-C) from Baseline (Week 0 of Study 733-005/UP1002) to Week 126 (Week 48 in Study AEGR-733-012).|Baseline and Week 126|Week 126 Completers Population|||Percent Change||Standard Deviation|Mean
1438988|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439043|NCT00943150|Secondary|Diet Volume|Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||units on a scale||Standard Deviation|Mean
1438989|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438990|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post second H1N1 vaccination is study Day 63 for Group 4, and is study Day 42 for all other groups.|Day 0 prior to first vaccination and 21 days after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438991|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. This outcome restricts to age stratum.|||Participants|||Number
1438992|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438993|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, 21 days after second H1N1 vaccination is study Day 63, all others it is study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after the second H1N1 vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438994|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438995|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438996|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438997|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438998|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.|Day 21 after first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1438999|NCT00943202|Primary|Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.|Day 0 through 180 days after the last vaccination|All participants receiving at least one vaccination are included in the safety cohort. Analyses are as treated.|||Participants|||Number
1439000|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439001|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439002|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439003|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439189|NCT00941928|Primary|Time to Progression (TTP)|TTP calculated as average time, in months, from baseline to participants disease progression or death, monitored for a minimum of 1 year|1 Year|Both participants had recurrent disease before single month assessment therefore no data was analyzed. Study was terminated early due to slow accrual.||||||
1439004|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439005|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439006|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439007|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439008|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439009|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439010|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439011|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.|Within 8 days (Day 0-7) post TIV vaccination|All participants receiving the TIV vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439044|NCT00943150|Secondary|Activity Level|Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||units on a scale||Standard Deviation|Mean
1439012|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439013|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439014|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.|Within 8 days (Day 0-7) post second H1N1 vaccination|All participants receiving the second H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439015|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439016|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439017|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.|Within 8 days (Day 0-7) post first H1N1 vaccination|All participants receiving the first H1N1 vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439018|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439019|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439045|NCT00943150|Secondary|Postoperative Pain Levels|Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.|Postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||units on a scale||Standard Deviation|Mean
1439020|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439021|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 3 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439022|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439023|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. One Group 2 participant did not report temperatures. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439024|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439025|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439026|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439027|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1440461|NCT00931632|Secondary|Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Intent-to-treat population|||Participants|||Count of Participants
1439028|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439029|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days. Groups 1 and 4 only had a third vaccination day.|Within 8 days (Day 0-7) post third vaccination|All participants receiving the third vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439030|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439031|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439032|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post second vaccination|All participants receiving the second vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439033|NCT00943202|Primary|Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439034|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439035|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater. Day 21 after last vaccination is study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439046|NCT00943150|Secondary|Narcotic Consumption|Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.|Intraoperative and postoperative (0 to 10 days)|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||Fentanyl microgram units/g||Standard Deviation|Mean
1439047|NCT00943150|Secondary|Change in Hemoglobin|The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.|Intraoperative|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||g/dL||Standard Deviation|Mean
1439048|NCT00943150|Secondary|Total Drainage Output||0 to 10 days postoperatively|One subject was removed from the analysis of secondary variables owing to a protocol deviation.|||mL||Standard Deviation|Mean
1439036|NCT00943202|Secondary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439037|NCT00943202|Secondary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and Day 21 after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. One participant was excluded due to receipt of non-study vaccine, 3 due to Influenza-like illness, and 1 due to H1N1 infection. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439038|NCT00943202|Secondary|Number of Participants Age 6 to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination|Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the titer at 21 days after last vaccination was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the titer at 21 days after last vaccination was an increase by 4-fold or more. Day 21 after last vaccination was study Day 63 for Groups 1 and 4, and study Day 42 for Groups 2 and 3.|Day 0 prior to first vaccination and 21 days after last vaccination|Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Two participants were excluded due to receipt of non-study vaccines and one due to Influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439039|NCT00943202|Primary|Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination|Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.|Within 8 days (Day 0-7) post first vaccination|All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated. This outcome measure is restricted to protocol-defined age stratum.|||Participants|||Number
1439040|NCT00943202|Primary|Number of Participants Age 10 to 17 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439041|NCT00943202|Primary|Number of Participants Age 36 Months to 9 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439042|NCT00943202|Primary|Number of Participants Age 6 Months to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine|Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more. Day 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.|Day 0 prior to vaccination and 21 days after the first H1N1 vaccination|Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Analyses are as treated. This outcome restricts to age stratum.|||Participants|||Number
1439050|NCT00943150|Primary|Acute Thermal Injury Depth|"Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.~Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation."|Immediately postoperative||||micrometers||Standard Deviation|Mean
1439051|NCT00943124|Primary|Total Urinary Excretion of Niacin and Its Metabolites||96 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 216 subjects were available for both MK0524B and Simvastatin + MK0524A for analysis of urinary excretion of nicotinuric acid and metabolites|||µmol||Standard Deviation|Least Squares Mean
1439052|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Nicotinuric Acid|Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin|24 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4) and missing samples (N=1), data from a total of 215 and 216 subjects available for plasma nicotinuric acid analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL||Standard Deviation|Least Squares Mean
1439053|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Laropiprant||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively|||nmol/L||Standard Deviation|Least Squares Mean
1439054|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Laropiprant|Plasma Area Under the Curve of Laropiprant|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), data from a total of 217 and 216 subjects were available for laropiprant AUC(0 to infinity) analysis for MK0524B and Simvastatin + MK0524A, respectively|||nmol/L * hour||Standard Deviation|Least Squares Mean
1439055|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin||48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 209 and 210 subjects were available for simvastatin Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL||Standard Deviation|Least Squares Mean
1439056|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48 Hour)) for Simvastatin|Plasma Area Under the Curve of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=2) and the limitation of the assay (N=10), data from a total of 208 and 210 subjects were available for simvastatin AUC(0-48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL * Hour||Standard Deviation|Least Squares Mean
1439057|NCT00943124|Primary|Peak Plasma Concentration (Cmax) of Simvastatin Acid|Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin|48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 201 and 202 subjects were available for simvastatin acid Cmax analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL||Standard Deviation|Least Squares Mean
1439058|NCT00943124|Primary|Plasma Area Under the Curve (AUC(0 to 48hr)) for Simvastatin Acid|Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin|Through 48 Hours Post Dose|Two hundred-twenty (220) subjects were enrolled in this study. Due to early dropout (N=4), mis-handling of plasma samples (N=10) and the limitation of the assay (N=10), data from a total of 200 and 202 subjects were available for simvastatin acid AUC(0 to 48 hour) analysis for MK0524B and Simvastatin + MK0524A, respectively.|||ng/mL * Hour||Standard Deviation|Least Squares Mean
1439059|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 208|Percent change in liver volume = ([liver volume at Week 208 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 liver volume assessment.|||percent change||Standard Deviation|Mean
1439060|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (in MN) at Week 208|Percent change in spleen volume = ([spleen volume at Week 208 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 spleen volume assessment.|||percent change||Standard Deviation|Mean
1439061|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 208|Percent change in platelet counts = ([platelet count at Week 208 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 platelet assessment.|||percent change||Standard Deviation|Mean
1439062|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 208|Absolute change = hemoglobin level at Week 208 minus hemoglobin level at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 hemoglobin assessment.|||g/dL||Standard Deviation|Mean
1439063|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 208 minus Z-score at baseline.|Baseline, Week 208|FAS population for LTTP. Number of participants analyzed = participants with both baseline and Week 208 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 208 Z-score assessment for specified bone area.|||Z-score||Standard Deviation|Mean
1439064|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 208|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant's bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 208 minus T-score at baseline.|Baseline, Week 208|Number of participants analyzed = participants with both baseline and Week 208 T-score assessment.|||T-Score||Standard Deviation|Mean
1439065|NCT00943111|Secondary|Percent Change From Baseline in Liver Volume (in MN) at Week 52|Percent change in liver volume = ([liver volume at Week 52 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in multiples of normal.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 liver volume assessment. Eliglustat participants switching to imiglucerase were excluded.|||percent change||Standard Error|Least Squares Mean
1439066|NCT00943111|Secondary|Percent Change From Baseline in Spleen Volume (MN) at Week 52|Percent change in spleen volume = ([spleen volume at Week 52 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 spleen volume assessment. Eliglustat participants switching to imiglucerase were excluded.|||percent change||Standard Error|Least Squares Mean
1439067|NCT00943111|Secondary|Percent Change From Baseline in Platelet Counts at Week 52|Percent change in platelet counts = ([platelet count at Week 52 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 platelet assessment. Eliglustat participants switching to imiglucerase were excluded.|||percent change||Standard Error|Least Squares Mean
1439068|NCT00943111|Secondary|Absolute Change From Baseline in Hemoglobin Levels at Week 52|Absolute change = hemoglobin level at Week 52 minus hemoglobin level at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 hemoglobin assessment. Eliglustat participants switching to imiglucerase were excluded.|||g/dL||Standard Error|Least Squares Mean
1439069|NCT00943111|Secondary|Hemoglobin Level||Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline hemoglobin assessment.|||gram per deciliter (g/dL)||Standard Deviation|Mean
1439070|NCT00943111|Secondary|Absolute Change From Baseline in Total Z-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2). Absolute change = Z-score at Week 52 minus Z-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 Z-score assessment. Here, 'n' signifies participants with both baseline and Week 52 Z-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.|||Z-score||Standard Error|Least Squares Mean
1439071|NCT00943111|Secondary|Total Z-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by DXA to determine Z-score for each bone area and total bone mineral density. The Z-score bone density categories are: normal (score >-2) and below normal (score <=-2).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline Z-score assessment. Here, 'n' signifies participants with baseline Z-score assessment for specified bone area.|||Z-score||Standard Deviation|Mean
1439072|NCT00943111|Secondary|Absolute Change From Baseline in Total T-Scores for Bone Mineral Density at Week 52|Images of the spine and bilateral femur were obtained by DXA to determine T-score for each bone area and total bone mineral density. T-score compares participant’s bone density with that of healthy young participant. The T-score bone density categories are: normal (score >-1), osteopenia (score -2.5 to <=-1), and osteoporosis (score <= -2.5). Absolute change = T-score at Week 52 minus T-score at baseline.|Baseline, Week 52|Per protocol population for PAP. Number of participants analyzed = participants with both baseline and Week 52 T-score assessment. Here, 'n' signifies participants with both baseline and Week 52 T-score assessment for specified bone area. Eliglustat participants switching to imiglucerase were excluded.|||T-score||Standard Error|Least Squares Mean
1439073|NCT00943111|Secondary|Total T-Scores for Bone Mineral Density|Images of the spine and bilateral femur were obtained by dual energy X-Ray absorptiometry (DXA) to determine T-score for each bone area and total bone mineral density. T-score compares participant’s bone density with that of healthy young participant. The T-score bone density categories are: normal (score greater than [>]-1), osteopenia (score -2.5 to less than or equal to [<=] -1), and osteoporosis (score <= -2.5).|Baseline|Per protocol population for PAP. Number of participants analyzed = participants with baseline T-score assessment. Here, 'n' signifies participants with baseline T-score assessment for specified bone area.|||T-score||Standard Deviation|Mean
1439074|NCT00943111|Primary|Percentage of Participants Who Remained Stable Annually for 4 Years During the LTTP|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in MN). Stable hematological parameters were defined as hemoglobin level did not decrease >1.5 g/dL from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume did not increase >20% from baseline.|Week 52 up to week 208|FAS population for LTTP: included all participants who received at least 1 dose of eliglustat in the extension study period. Number of participants analyzed=participants at risk at specified time-points. Here 'n' signifies number of participants with available data for specified time-points.|||percentage of participants|||Number
1439075|NCT00943111|Primary|Percentage of Participants Who Remained Stable for 52 Weeks During the Primary Analysis Period|For a participant to be classified as stable, the participant must have remained stable in hematological parameters (hemoglobin levels and platelet counts) and organ volumes (spleen, when applicable, and liver volumes in multiples of normal [MN]). Stable hematological parameters were defined as hemoglobin level did not decrease more than (>) 1.5 gram per deciliter (g/dL) from baseline and platelet count did not decrease >25% from baseline. Stable organ volumes were defined as spleen volume (in MN) did not increase >25% from baseline, if applicable, and liver volume (in MN) did not increase >20% from baseline.|Baseline up to Week 52|Per protocol population for PAP included participants who were at least 80% compliant with treatment during PAP, had no major protocol deviations, and did not exhibit hematological decline as a result of medically determined etiologies other than Gaucher disease.|||percentage of participants||95% Confidence Interval|Number
1439352|NCT00939991|Secondary|Phase II: Number of Patients With Grade 2 or Greater, Treatment-related Toxicities|Phase II: Number of patients with grade 2 or greater, treatment-related toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|3 years||||participants|||Number
1439076|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the ITT population: defined as all randomised patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose.|||mm||95% Confidence Interval|Least Squares Mean
1439077|NCT00943098|Secondary|PIDs||at 8 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439078|NCT00943098|Secondary|PIDs||at 7 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439079|NCT00943098|Secondary|PIDs||at 6 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439080|NCT00943098|Secondary|PIDs||at 5 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439081|NCT00943098|Secondary|PIDs||at 4 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439082|NCT00943098|Secondary|PIDs||at 3 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439083|NCT00943098|Secondary|PIDs||at 2 hours post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439084|NCT00943098|Secondary|PIDs||at 90 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439085|NCT00943098|Secondary|PIDs||at 60 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439086|NCT00943098|Secondary|PIDs||at 45 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439087|NCT00943098|Secondary|PIDs||at 30 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439088|NCT00943098|Secondary|PIDs||at 15 minutes post-dose.|Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).|||mm||Standard Deviation|Mean
1439089|NCT00943098|Primary|Pain Intensity Difference (PID)|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|1.5 hours|Analysed patients are those included in the PP population: all patients included in the ITT population who also met all inclusion/exclusion criteria and who did not have any major protocol violation, and with post-surgical pain assessment at the primary endpoint.|||mm||95% Confidence Interval|Least Squares Mean
1439090|NCT00943072|Secondary|Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF)|The NEI VFQ-25 assesses visual function and quality of life. Total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline and at Week 24||||scores on a scale||Standard Deviation|Mean
1439091|NCT00943072|Secondary|Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks||Baseline to Week 24|Full Analysis Set|||percentage of participants|||Number
1439092|NCT00943072|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF||Baseline and at Week 24|Full Analysis Set|||microns||Standard Deviation|Mean
1439093|NCT00943072|Secondary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF)|Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.|Baseline and at Week 24|Full Analysis Set|||letters correctly read||Standard Deviation|Mean
1439094|NCT00943072|Primary|Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score|"Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline.~Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning."|Baseline and at Week 24|Full Analysis Set|||percentage of participants|||Number
1439121|NCT00942890|Secondary|Pain Interference|Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items.|0, 3, 6, 9, 12 wks||||units on a scale||Standard Deviation|Mean
1439095|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 2 and Week 4|Secondary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.|||mmHg||Standard Deviation|Mean
1439096|NCT00942994|Other Pre-specified|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2 and Week 4|Primary objective at additional timepoint.|Baseline, Week 2 and Week 4|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline is reported for 197 patients.|||mmHg||Standard Deviation|Mean
1439097|NCT00942994|Secondary|Percentage of Responders (Defined as Patients With MSSBP < 140 mmHg or a Reduction From Baseline in MSSBP of ≥20 mmHg) During 8 Weeks.|To compare the cumulative percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving a response before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.|||Percentage of Responders|||Number
1439098|NCT00942994|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as MSSBP < 140 mmHg and MSDBP < 90 mmHg) During 8 Weeks|To evaluate the cumulative percentage of patients achieving Blood Pressure control (defined as patients achieving an MSSBP <140 mmHg and MSDBP <90 mmHg) during 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension. Cumulative refers to achieving BP control before or at the corresponding visit.|8 weeks|Analysis was based on the Full Analysis Set (FAS) consisting of all patients to whom study medication had been assigned.|||Percentage of Participants|||Number
1439099|NCT00942994|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To evaluate change from baseline in MSDBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.|||mmHg||Standard Deviation|Mean
1439100|NCT00942994|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.|Baseline and week 8|Analysis was based on the Full Analysis Set consisting of all patients to whom study medication had been assigned. Last-observation-carried-forward was used. Baseline was not carried forward. In the Aliskiren/Amlodipine/HCTZ group, 5 patients did not have a post baseline measure. Hence, change from baseline to week 8 is reported for 197 patients.|||mmHg||Standard Deviation|Mean
1439101|NCT00942968|Other Pre-specified|Change From Baseline in Creatinine Clearance at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 in Severely Renal Impaired Participants|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age.|Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Severely renal-impaired population included all participants who had at least 1 dose of study drug and had severe renal impairment at the baseline or developed severe renal impairment (CrCl) < 30 milliliter per minute during the study. Here, n’ signifies those participants who were evaluable at specified time points.|||mL/min||Standard Deviation|Mean
1439102|NCT00942968|Other Pre-specified|Other Pre-specified: Number of Participants With Clinically Significant Electrocardiogram Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
1439103|NCT00942968|Other Pre-specified|Number of Participants With Abnormal Physical Examinations Findings|Physical examinations included head, ears, nose, throat (ENT), neck, heart, chest, lungs, abdomen, extremities, neurological systems, skin, general appearance and others (thigh, abdomen unobtrusive scar, breast, cardio-vascular, constitutional, face, genitalia, genitourinary, gastrointestinal, hematologic, left ankle unobtrusive scar, lymph nodes, lymphatic, malaise/fatigue, mouth, musculoskeletal, musculoskeletal, peripherally inserted central catheters line site left arm, psychiatric, skeletal, urinary, weight, activity level, bladder irritation, dyspnea and eastern cooperative oncology group performance status [used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead]). Abnormality in physical examinations was based on investigator’s discretion.|Baseline (Day 1), Week 1, 4, 8, 12, 24, 36, 48, 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium. Here ‘n’ signifies those participants who were evaluable at specified categories.|||participants|||Number
1439118|NCT00942968|Primary|Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of greater than or equal to (>=) 2 gram per deciliter (g/dL), 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 2 up to Month 6|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
1439104|NCT00942968|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for abnormality: Hemoglobin greater than or equal to(>=)130*lower limit of normal(LLN); less than or equal to(<=)170*upper limit of normal(ULN), hematocrit >=0.39*LLN;<=0.51*ULN, red blood cell >=4.5*LLN;<=5.9*ULN, platelet>=150*LLN;<= 450*ULN, white blood cells >=4*LLN;<=11*ULN; lymphocytes>=0.09;<=0.44, neutrophils=>0.16*LLN;<=0.7*ULN, eosinophils<=0.04*ULN, basophils<=0.02*ULN, monocytes>0.08*ULN; bilirubin >=5.1*LLN;<=22.2*ULN, aspartate aminotransferase >=13*LLN;<=36*ULN, alanine aminotransferase>=11*LLN;<=54*ULN, alkaline phosphatase>=31*LLN ;<=104 *ULN, total protein>=60*LLN; <=76*ULN, albumin=>35*LLN;<=50*ULN, glucose>=3.77 ;<=6.05;blood urea nitrogen>=1.785*LLN;<=7.5*ULN, creatinine>=70.7*LLN;<=114.9*ULN, creatinine kinase>=30*LLN ;<=280*ULN, lactate dehydrogenase>=85*LLN;<=180*ULN, sodium>=137*LLN ;<=144*ULN, potassium >=3.5*LLN;<=5*ULN, chloride>=102*LLN;<=111*ULN, calcium>=2.22*LLN ;<=2.57*ULN, phosphorus=>0.81 ;<=1.45); nitrogen cholesterol>=1.78*LLN ;<=7.49*ULN.|Baseline (Day 1) up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
1439105|NCT00942968|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline (Day 1) up to Week 52|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
1439106|NCT00942968|Secondary|Time to First Occurrence of New or Recurrent VTE or CVT Adjudicated by Central Adjudication Committee|Time to first occurrence of new or recurrent VTE or CVT was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE or CVT. VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE) .DVT is a blood clot in the deep veins of the leg. If a DVT clot that breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan, contrast venography or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography.|Month 1 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.|||days||Standard Error|Mean
1439107|NCT00942968|Secondary|Time to First Occurrence of New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee|Time to first occurrence of new or recurrent VTE was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first VTE. VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram.|Month 1 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium.|||days||Standard Error|Mean
1439108|NCT00942968|Secondary|Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT)|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘n’ signifies those participants who were evaluable at specified time intervals.|||participants|||Number
1439109|NCT00942968|Secondary|Number of Participants With New or Recurrent Venous Thromboembolism (VTE) or Central Venous Thrombosis (CVT) Adjudicated by Central Adjudication Committee|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. CVT is blood clot of the venous channels in the brain. CVT was diagnosed by contrast venography or ultrasonography. In this outcome measure, number of participants with new or recurrent VTE or CVT (adjudicated by Central Adjudication Committee) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘n’ signifies those participants who were evaluable at specified time intervals.|||participants|||Number
1439119|NCT00942903|Secondary|Noise at Stoma Occlusion|the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME|3 weeks||||patients|||Number
1439120|NCT00942903|Primary|Patient Preference for Provox HME or Provox XtraHME|the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.|3 weeks||||Patients|||Number
1440462|NCT00931632|Secondary|Length of Birth Hospitalization||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Number of subjects within the Intent-to-treat population with available data|||Days||Standard Deviation|Mean
1439110|NCT00942968|Secondary|Number of Participants With Investigator Identified New or Recurrent Venous Thromboembolism (VTEs)|VTEs included both DVT and PE. DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes PE. When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, 'n' signifies those participants who were evaluable at specified time intervals.|||participants|||Number
1439111|NCT00942968|Secondary|Time to First Occurrence of Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee|Time to first occurrence of any bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first bleeding event (major or minor). A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding.|Month 1 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||days||Standard Error|Mean
1439112|NCT00942968|Secondary|Time to First Occurrence of Major Bleeding Event Adjudicated by Central Adjudication Committee|Time to first occurrence of major bleeding event was defined as the time interval (in days) between the date of first study treatment and the date of documentation of first major bleeding event. A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death.|Month 1 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||days||Standard Error|Mean
1439113|NCT00942968|Secondary|Number of Participants With Fatal Bleeding Events|Fatal bleeding events refers to those bleeding events which leads to death of participant. In this outcome measure, number of participants with fatal bleeding events were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
1439114|NCT00942968|Secondary|Number of Participants With Any Bleeding Event (Major or Minor) Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. A bleeding event was considered as minor if it was clinically overt but not meeting the criteria for major bleeding. In this outcome measure, number of participants with any (major or minor) bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 1 up to Month 6, Month 7 up to Month 12, Month 1 up to Month 12, Month 2 up to Month 6, and Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
1439115|NCT00942968|Secondary|Number of Participants With Investigator Identified Major Bleeding Events|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (identified by investigator) were reported.|Month 1 up to Month 6; Month 7 up to Month 12; Month 1 up to Month 12; Month 2 up to Month 6; Month 2 up to Month 12|Safety population included all participants who received at least 1 treatment with dalteparin sodium.|||participants|||Number
1439116|NCT00942968|Primary|Number of Participants With New or Recurrent Venous Thromboembolism (VTE) Adjudicated by Central Adjudication Committee|VTEs included both deep vein thrombosis (DVT) and pulmonary embolism (PE). DVT is a blood clot in the deep veins of the leg. If a DVT clot breaks off (embolizes) from a vein wall and flows towards the lungs and blocks some or all of the blood supply, it becomes pulmonary embolism (PE). When a blood clot (thrombus) breaks, loose and travels in the blood, this is called a venous thromboembolism. DVT was diagnosed using either computed tomography scan or contrast venography. PE was diagnosed by either radionuclide ventilation-perfusion studies, contrast CT scan or an angiogram. In this outcome measure, number of participants with new or recurrent VTE (adjudicated by Central Adjudication Committee) were reported.|Month 7 up to Month 12|Efficacy analysis population included all participants who received at least 1 study treatment with dalteparin sodium. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1439117|NCT00942968|Primary|Number of Participants With Major Bleeding Events Adjudicated by Central Adjudication Committee|A bleeding event was considered as major if it was clinically overt and satisfies 1 or more of the following criteria: 1) bleeding accompanied by a decrease in hemoglobin of >=2 g/dL, 2) bleeding occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding), 3) bleeding leads to a transfusion of two or more units of packed red blood cells, 4) bleeding leads to death. In this outcome measure, number of participants with major bleeding events (adjudicated by Central Adjudication Committee) were reported.|Month 7 up to Month 12|Safety population included all participants who received at least one 1 treatment with dalteparin sodium.|||participants|||Number
1441450|NCT00924833|Secondary|Sitting Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
1439129|NCT00942851|Secondary|% Blepharospasm Disability Scale (BDS) Change at 3 Months|% BDS change at 3 months. The BDS is a quality of life scale ranging from 0 (no symptoms) to 26 (maximum impact of symptoms on quality of life). The questions are specific for impairment related to blepharospasm. We compared the percentage change over three months in the active and placebo arms.|baseline to 3 months|One placebo arm participant discontinued study due to unrelated personal problems|||percentage change||Standard Deviation|Mean
1439130|NCT00942851|Secondary|Change in the JBRS at 3 Months|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time.|baseline to 3 months|One placebo arm participant dropped out due to unrelated personal problems|||points||Standard Deviation|Mean
1439131|NCT00942851|Primary|Time Until Jankovic Blepharospasm Rating Scale (JBRS) Reverts Back to Baseline|The JBRS is a severity scale for blepharospasm, ranging from 0 (no symptoms) to 8 (the most severe symptoms, functionally blind). It includes measures of blink frequency and severity of abnormal eye closure. The scale was measured at baseline (before intervention) and followed over time. Return to baseline value represents loss of benefit from BoNT injection. The time to return to baseline JBRS is an indication of added benefit from the topical intervention.|3-7 months||||month||Standard Deviation|Mean
1439132|NCT00942825|Primary|The Primary Efficacy Endpoint is Progression Free Survival, Analyzed in the Treated Population. PFS is Assessed From Randomization Until Either Tumor Progression, as Per RECIST Criteria, or Until Death Due to Any Reason.||15 June 2009 to 30 September 2012|Treated population|||days||95% Confidence Interval|Median
1439133|NCT00942786|Other Pre-specified|Association Between Preoperative NT-ProBNP and Occurence of Adverse Cardiac Events|Evaluation of the association between preoperative NT-ProBNP and occurence of adverse cardiac events|postoperatively (index surgery) until a median follow-up of 34 months||||pg/ml||Inter-Quartile Range|Median
1439134|NCT00942786|Other Pre-specified|NT-ProBNP Preoperative|NT-ProBNP was measured 0-24 hours before induction of anesthesia|0-24 hours before induction of anesthesia|Consecutive patients undergoing emergent non-cardiac surgery|||pg/ml||Inter-Quartile Range|Median
1439135|NCT00942786|Primary|Occurence of Adverse Cardiac Events|"Occurence of major adverse cardiac events (composite of nonfatal myocardial infarction, acute heart failure or death).~Non-fatal Myocardial infarction was defined as a typical increase and decrease of troponin together with evidence of myocardial ischemia with at least one of the following: symptoms of ischemia, ECG changes indicative of ischemia or new Q waves, or imaging evidence of new regional wall motion abnormality.~Acute heart failure was defined as clinical signs and symptoms of heart failure with echocardiographic evidence of cardiac dysfunction and clinical response to treatment directed towards heart failure."|postoperatively (index surgery) until a median follow-up of 34 months||||participants|||Number
1439136|NCT00942734|Primary|12-Week Progression-Free Survival (PFS)|Tumor assessments performed by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) after 4 weeks, 12 weeks, then every 8 weeks thereafter. Participants who received at least one dose of RAD001+erlotinib and who die before 12 weeks, counted as having progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progression-free survival defined as stable disease or better. Progressive Disease (PD): >20% increase in sum of LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started.|12 weeks|Eight participants were not evaluable.|||Percentage of Participants|||Number
1439137|NCT00942604|Secondary|Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions|Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area|57 days|Intention to treat population|||participants|||Number
1439138|NCT00942604|Primary|Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions|Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area|57 days|Intention to treat population|||participants|||Number
1439139|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||95% Confidence Interval|Least Squares Mean
1439140|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 8 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439141|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 7 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439142|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 6 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439143|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 5 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439144|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 4 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439145|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 3 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439146|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 2 hours post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439147|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 90 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439148|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 60 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439149|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 45 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439150|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 30 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439151|NCT00942448|Secondary|PID|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 15 minutes post-dose.|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||Standard Deviation|Mean
1439152|NCT00942448|Primary|Pain Intensity Difference (PID) on a 0-100 VAS|Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|at 1.5 hours after treatment administration|The reported number of analized participants were included in the ITT which was defined as all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint);|||mm||95% Confidence Interval|Least Squares Mean
1439153|NCT00942422|Primary|Sustained M-protein Reduction of ≥ 25% From Baseline|"This is a monthly blood test, done at the beginning of each cycle of therapy. The M-protein is a surrogate marker routinely used to estimate the degree of plasma cell cyto-reduction brought about by therapy. In active multiple myeloma, a 25% reduction in the M-protein level would correspond to a minor response, an improvement recognized as having some clinical benefit."|Day one of each 28-day cycle for a total of up to 6 cycles||||percentage of patients|||Number
1439154|NCT00942409|Primary|Overall Response Rate||2 Years|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure||||||
1439155|NCT00942266|Secondary|Fluorouracil Steady-state Pharmacokinetics|Blood samples will be collected for determination of plasma 5-FU steady state concentration at 6 hours after start of 5-FU continuous infusion. The mean per treatment arm are presented.|Day 1|All treated and eligible patients|||ng/ml||95% Confidence Interval|Mean
1439156|NCT00942266|Secondary|Vorinostat Pharmacokinetics|Blood samples (5 ml of blood each) will be collected in red-top vacutainers (no anticoagulant) at 0 (pre- vorinostat), 0.5, 1, 2, 3, 4, 6, and 8 hours after the vorinostat dose on the first day of 5-FU infusion on cycle 1 (day 2 of cycle 1). Mean area under the curve is presented with 95% CI.|day 2 (cycle 1)|Vorinostat PKs were be performed on day 2 of vorinostat in the first 10 patients of each arm treated at RPCI|||hr∙μM||95% Confidence Interval|Mean
1439157|NCT00942266|Secondary|Overall Survival||Every 12 weeks|All treated and eligible patients; per protocol|||months||95% Confidence Interval|Median
1439159|NCT00942266|Secondary|Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Every 8 weeks; up to 100 weeks.|All treated and eligible patients; per protocol|||percentage of participants||95% Confidence Interval|Number
1439160|NCT00942266|Secondary|Median Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks, up to 100 weeks.|All treated and eligible patients; per protocol|||months||95% Confidence Interval|Median
1439161|NCT00942266|Primary|Disease Control Rate (Stable Disease or Objective Response)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|At 2 months|All treated and eligible patients; per protocol|||percentage of participants||95% Confidence Interval|Number
1439162|NCT00942188|Secondary|Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)|Pharmacokinetics Measured by Serum Concentration at End of Dosing.|Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose|All participants who received at least one dose of study drug and had evaluable PK data. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1439163|NCT00942188|Secondary|PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)|Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.|Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1439164|NCT00942188|Secondary|Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)|"The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model.~Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug."|Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose|Full Analysis Set: All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1439165|NCT00942188|Secondary|Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12|The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.|Baseline, week 10, week 12|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1439166|NCT00942188|Secondary|Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks|The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT.|Baseline, 12 weeks|Full analysis set. All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).|||participants|||Number
1439167|NCT00942188|Secondary|Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks|Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.|Baseline, 12 weeks|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||microinternational Units per liter||Standard Error|Least Squares Mean
1439168|NCT00942188|Secondary|Change From Baseline in Fasting Glucose at 12 Weeks|Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.|Baseline, 12 weeks|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1439169|NCT00942188|Primary|Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks|Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.|Baseline, 12 weeks|Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1439353|NCT00939991|Secondary|Phase II: Median Overall Survival (OS)|Phase II: Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|3 years||||months||95% Confidence Interval|Median
1439171|NCT00942175|Primary|Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.|Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate.|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PD statistical analyses for those parameters.|||percentage of MPA||Standard Deviation|Mean
1439172|NCT00942175|Primary|Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).|PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry).|24-hour post Day 9 dose in each period.|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacodynamics (PD) statistical analyses for this parameter.|||percent inhibition||Standard Deviation|Mean
1439173|NCT00942175|Primary|Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel’s Active Metabolite.|Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 9 of each period|All participants who had valid parameter estimates for both formulations within PPI groups were included in the PK statistical analyses for those parameters.|||ng*hr/ML||Standard Deviation|Mean
1439174|NCT00942175|Primary|Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel’s Active Metabolite.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 9 of each period|All participants who had valid parameter estimates for both regimens within a PPI group were included in the pharmacokinetics (PK) statistical analyses for this parameter.|||ng/mL||Standard Deviation|Mean
1439175|NCT00942149|Secondary|Adverse Events Will be Monitored.||7 days following last dose of study drug|||||||
1439176|NCT00942149|Primary|PK of Daptomycin|Area under the curve|24 hours|all 20 subjects were analyzed|||mg*h/L||Full Range|Median
1439177|NCT00942084|Primary|Minimum Steady State Concentration (Cminss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||mg/L||Full Range|Median
1439178|NCT00942084|Primary|Steady State Concentration at 50% of the Dosing Interval (C50ss)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||mg/L||Full Range|Median
1439179|NCT00942084|Primary|Maximum Steady State Concentration (Cmaxss)||up to 3 dasy of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||mg/L||Full Range|Median
1439180|NCT00942084|Primary|Half-life (T1/2)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||h||Full Range|Median
1439181|NCT00942084|Primary|Volume of Distribution (V)||up to 3 days of study drug administration and 10 days of safety monitoring|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||L/kg||Full Range|Median
1439182|NCT00942084|Primary|Clearance (CL)|"Timeframe:~Version 1:0-5 min,2-4 hrs,6-8 hrs post doses 1 and 5-15; prior to doses 5-15 Version 2:0-15 min post doses 1 and 5-15; within 30 min prior to doses 2 and 5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose"|V1:0-5 min,2-4 hrs,6-8 hrs post Doses 1&5-15;prior to doses 5-15; V2:0-15 min post doses 1&5-15; within 30 min prior to doses 2&5-15; 2-3 hrs post doses 5-15; 15-18 hrs post last dose|32 infants enrolled. 2 infants died. 2 infants did not contribute PK samples to the analysis. 28 contributed PK samples to the final analysis.|||L/h/kg||Full Range|Median
1439183|NCT00941993|Primary|Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects).||Day 0||||participants|||Number
1439184|NCT00941993|Other Pre-specified|Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale.|"The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.~Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears."|Day 0|Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted|||units on a scale||Standard Deviation|Mean
1439185|NCT00941993|Secondary|Subject/Parent Reported Satisfaction With the In-office Procedure|"Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: ‘Overall, I am satisfied with the whole procedure’. Response options included: ‘Strongly Disagree’, ‘Disagree’, ‘Neutral’, ‘Agree’ or ‘Strongly Agree’. The number of respondents who reported that they ‘agree’ or ‘strongly agree’ that they were satisfied with the whole procedure are reported.~The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period."|Day 0||||% adult subjects or parents||95% Confidence Interval|Number
1439186|NCT00941993|Secondary|Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale|"Includes all subjects for whom Iontophoresis current delivery was initiated.~The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.~The Wong-Baker scores are reported by subject."|Day 0|Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available.|||units on a scale||Standard Deviation|Mean
1439187|NCT00941993|Primary|Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment|Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.|Day 0||||percentage of subjects||95% Confidence Interval|Number
1439190|NCT00941889|Primary|The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.|Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.|Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment|Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.|||participants|||Number
1439191|NCT00941863|Other Pre-specified|Other Adverse Events|Frequency Threshold for reporting Other Adverse Events: 5%. The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.|||Participants|||Number
1439192|NCT00941863|Other Pre-specified|Serious Adverse Events|The responses reported in these participants were from start of treatment until 18 Sep 2008.|From start of treatment until 18 Sep 2008, up to 6 years|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib.|||Participants|||Number
1439193|NCT00941863|Secondary|Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1|Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.|At day 2 in study|subjects with valid PK profiles|||hours||Full Range|Median
1439194|NCT00941863|Secondary|Maximum Concentration (CMAX) Start From Day 2 of Cycle 1|Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.|At day 2 in study|subjects with valid PK profiles|||mg/L||Standard Deviation|Geometric Mean
1439195|NCT00941863|Secondary|Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.|At day 2 in study|subjects with valid pharmacokinetics (PK) profiles|||mg*h/L||Standard Deviation|Geometric Mean
1439196|NCT00941863|Secondary|Tumor Response|Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From start of treatment until progression or death occurs assessed every 6 weeks.|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population|||Participants|||Number
1439197|NCT00941863|Primary|Participants With Hematological and Biochemical Toxicities|Participants are considered at risk for toxicity if participants had a lab measurement for the toxicity >= National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 as defined by the NCI CTC version 2; SGOT: Serum Glutamic-Oxaloacetic Transaminase, SGPT: Serum Glutamic-Pyruvic Transaminase, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase.|Start of treatment until death or within 14 days last study drug intake|The Intent-To-Treat (ITT) population included subjects who received at least one dose of sorafenib or chemotherapy and had at least one post baseline assessment. Efficacy analyses were performed on the ITT population.|||Participants|||Number
1439198|NCT00941863|Primary|Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin|MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.|21 days|All subjects who received at least 1 dose of any study drug treatment were included in the Intent-To-Treat/safety populations. Efficacy parameters of time to death, time to progression, and response rate (confirmed partial response [PR] plus complete response [CR]) were determined for this population.|||mg|||Number
1439199|NCT00941798|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit|"The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control.~Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1439209|NCT00941798|Secondary|Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.|The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||participants|||Number
1439200|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime|24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||percentage of days||Standard Error|Least Squares Mean
1439201|NCT00941798|Secondary|Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime|"Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment.~Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and endpoint were included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1439202|NCT00941798|Secondary|Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime|Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||percentage of days||Standard Error|Least Squares Mean
1439203|NCT00941798|Secondary|Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period|"PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits.~Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient."|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and at final visit were included in this analysis.|||liters per second||Standard Error|Least Squares Mean
1439204|NCT00941798|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||liter||Standard Error|Least Squares Mean
1439205|NCT00941798|Secondary|Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||liters||Standard Error|Least Squares Mean
1439206|NCT00941798|Secondary|Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.|Baseline to the end of treatment (varying durations, up to 21 months)|Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis.|||liters||Standard Error|Least Squares Mean
1439207|NCT00941798|Secondary|Number of Patients With at Least One Asthma Worsening Post-baseline|The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) >= 20% from mean baseline on >= 3 consecutive days, nighttime symptom score >= 2 on >= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) >=20% from baseline at evening visits, daytime symptom score of 3 or 4 on >= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use >= 8 puffs on >= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||participants|||Number
1439208|NCT00941798|Secondary|Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids|Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||participants|||Number
1439270|NCT00941070|Secondary|Change in Sexual Function, Assessed Using the Sexual Function-Vaginal Changes Questionnaire||Baseline to up to 5 years|Data were not collected as the study was terminated prior to the time period for collection.||||||
1439210|NCT00941798|Primary|Time to First Serious Asthma Exacerbation|Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.|Up to 21 months|Full analysis set: all randomized patients who received at least one dose of study medication.|||months||Full Range|Median
1439211|NCT00941733|Secondary|Improvement % Diameter Stenosis (%DS) of the Target Leasion (TL) Assessed by Quantitative Vascular Angiography (QVA)|Percentage of participants with an improvement in percent diameter stenosis (%DS) of the target leasion (TL) assessed by Quantitative Vascular Angiography (QVA)|12 months|Angiographic subgroup only. Angio-target lesion is one identifiable single solitary or series of multiple adjacent lesions with a diameter stenosis higher than 70% and a cumulative length less than 100 mm that can be covered by a single IN.PACT Amphirion™; and Angio-target lesion is the only lesion in that vessel.|||percentage of participants analyzed|||Number
1439212|NCT00941733|Secondary|Days of Hospitalization|Days of hospitalization at 1 year|12 months|All randomized subjects with available data|||days||Standard Deviation|Mean
1439213|NCT00941733|Secondary|Procedural Success|Percentage of patients with a procedural success defined as combination of technical success, device success and absence of procedural complications|Day 1|All randomized subjects with available data|||percentage of participants analyzed|||Number
1439214|NCT00941733|Secondary|Technical Success|Percentage of technical success defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography|Day 1|Number of device deployments|||percentage of device deployments|||Number
1439215|NCT00941733|Secondary|Device Success|Percentage of device success defined as exact deployment of the device according to the instructions for use as documented with suitable imaging modalities|Day 1|Number of device deployments|||percentage of device deployments|||Number
1439216|NCT00941733|Secondary|MAE (Major Adverse Events)|Percentage of participants with a MAE (Major Adverse Events) at 1 year. Major Adverse Events, defined as Death of any Cause, Major Amputation of target limb, Minor Amputation of target limb|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
1439217|NCT00941733|Secondary|Walking Capacity Assessment|"Walking Impairment assessment by WIQ at 1 year compared to baseline. The Walking Impairment Questionnaire (WIQ) is a questionnaire for evaluating walking impairment in patients with peripheral arterial disease (PAD). This can be used to identify patients with significant impairment and to monitor effectiveness of therapeutic interventions. The questionnaire was self-administered by the patients and contains three domains measuring three important factors of walking impairment in patients with intermittent claudication: (1) difficulty walking a distance during the past month, (2) difficulty walking at a certain speed during the past month, (3) symptoms associated with walking impairment. For each separate domain, a subscore was calculated. The total WIQ score was defined as the mean of the three subscores.~A WIQ score of 42.5 or less identified low performers; while a score of 75.5 or more identified high performers. The WIQ score range is 0 (minimum) – 100 (maximum)."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for Walking Impairment assessment at baseline and 1 year|||units on a scale||Standard Deviation|Mean
1439218|NCT00941733|Secondary|Quality of Life Assessment by EQ5D|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ-5D is a standardised measure of health status and economic appraisal. The EQ-5D-3L essentially consists of 2 parts:the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. The EQ VAS records the respondent’s self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.~EQ-5D health states can be converted into a single summary index where 0.0='worst possible outcome' and 1.0='best possible outcome'."|12 months|Effectiveness Analysis sets – all randomized subjects with available data for EQ5D at baseline and 1 year|||units on a scale||Standard Deviation|Mean
1439219|NCT00941733|Secondary|Secondary Sustained Clinical Improvement|Percentage of participants that experienced a secondary sustained clinical improvement, specified as an improvement shift in the Rutherford classification of one class including the need for clinically driven TLR in amputation free surviving subjects at 1 year.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects|||percentage of participants analyzed|||Number
1439220|NCT00941733|Secondary|Primary Sustained Clinical Improvement|Percentage of participants that experienced primary sustained clinical improvement at 1 year, specified as an improvement shift in the Rutherford classification of one class in amputation free, clinically driven target lesion revascularization (TLR) free surviving subjects.|12 months|Analysis population consists of amputation free, clinically driven (target lesion revascularization)TLR free surviving subjects|||percentage of participants analyzed|||Number
1439221|NCT00941733|Secondary|Death, Amputation and Clinically Driven Target Lesion Revascularization (TLR)|Percentage of participants that experienced death, amputation and clinically driven Target Lesion Revascularization (TLR) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
1439222|NCT00941733|Secondary|Amputation Free Survival and Resolved Critical Limb Ischemia (CLI)|Percentage of participants with an amputation free survival and resolved Critical Limb Ischemia (CLI) at 1 year.|12 months|Percentage based on number of evaluable subjects for safety events (205 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
1441451|NCT00924833|Secondary|Resting Energy Expenditure||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
1439223|NCT00941733|Secondary|Amputation Free Survival and Wound Healing|Percentage of participants with a 1 year amputation free survival and wound healing. Wound healing is defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at a specified time point.|12 months|Percentage based on number of evaluable subjects for safety events (206 participants in the drug eluting balloon arm and 103 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
1439224|NCT00941733|Secondary|Rate of Wound Healing|Percentage of participants with completed wound healing, wound healing as defined as core lab adjudication of > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.|12 months|Patients with pre-existing wounds and/or occurence of new wounds|||percentage of patients analyzed|||Number
1439225|NCT00941733|Secondary|Amputation Free Survival|Percentage of participants with a 1 year amputation free survival.|12 months|Percentage based on number of evaluable subjects for safety events (227 participants in the drug eluting balloon arm and 111 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
1439226|NCT00941733|Primary|Composite of All Cause Death, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)|Percentage of participants experiencing all cause death, major amputation and clinically driven Target Lesion Revascularization (CD-TLR) at 6 months. CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s)|6 months|Percentage based on number of evaluable subjects for safety events (232 participants in the drug eluting balloon arm and 114 patients in the Standard PTA arm). All randomized subjects experiencing at least one component for the safety endpoint or with follow-up of at least 330 days post-procedure.|||percentage of participants analyzed|||Number
1439227|NCT00941733|Primary|Clinically Driven Target Lesion Revascularization (TLR) of the Target Lesion in the Amputation Free Surviving Patients|Percentage of participants in the amputation free survival population with Clinically driven Target Lesion Revascularization (CD-TLR) at 12 months, CD-TLR defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and / or increase in size of pre-existing wounds and / or occurrence of a new wound(s).|12 months|Amputation free surviving meaning participants without an amputation at 12 months. This analysis population consists of 196 participants in the Drug Eluting Balloon arm and 107 participants in the Standard PTA arm.|||percentage of participants analyzed|||Number
1439228|NCT00941733|Primary|Late Lumen Loss (LLL) of the Target Lesion by Quantitative Vascular Angiography (QVA)|The difference between minimum lumen diameter (MLD) immediately after Percutaneous Transluminal Angioplasty (PTA) and MLD at 12 months follow-up|12 months or at Target Lesion Revascularization (TLR) time|ITT|||mm||Standard Deviation|Mean
1439229|NCT00941720|Secondary|Pulmonary Toxicity|Toxicity criteria will be assessed and graded according to the National Cancer Institute (NCI) Common Terminology Criteria (CTC) v3.0. Estimated using exact 95% binomial confidence intervals.|At 6 months||||percentage of participants||95% Confidence Interval|Number
1439230|NCT00941720|Primary|Overall Survival|Number of patients alive at the end of the study period|at 6 months||||participants|||Number
1439231|NCT00941720|Primary|Relapse-free Survival|Number of participants without progressive disease at the end of the study period, using the definitions for complete response, partial response and progressive disease from the International Myeloma Working Group .|at 6 months||||participants|||Number
1439232|NCT00941681|Primary|AUC (Day 10)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).|||hr*ng/mL||Standard Deviation|Mean
1439233|NCT00941681|Primary|T Max (Day 10)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).|||hr||Standard Deviation|Mean
1439234|NCT00941681|Primary|C Max (Day 10)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post dose on day 10. Only one dose was administered on day 10 (final dose of study).|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing and 1 patient excluded from cohort 2 due to sudden death).|||ng/mL||Standard Deviation|Mean
1439235|NCT00941681|Primary|AUC (Day 1, Dose 1)|Area under the curve (AUC) measured in hours * nanograms per milliliter (hr*ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).|||hr*ng/mL||Standard Deviation|Mean
1439236|NCT00941681|Primary|T Max (Day 1, Dose 1)|Time of observed maximum plasma concentration (T max) measured in hours (hr) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).|||hr||Standard Deviation|Mean
1439237|NCT00941681|Secondary|Evaluate the Safety and Tolerability of Oral Formulations of CK-1827452 When Dosed to Steady-state in Patients With Stable Heart Failure.||1 week|||||||
1439238|NCT00941681|Primary|C Max (Day 1, Dose 1)|Maximum plasma concentration (C max) measured in nanograms per milliliter (ng/mL) post first dose and pre second dose on day 1. Doses are approximately 12 hours apart in cohort 1 and 3 and 8 hours apart in cohort 2.|1 day|PK population (4 patients excluded from cohort 3 analysis due to improper dosing).|||ng/mL||Standard Deviation|Mean
1439239|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)|4 weeks||||Micrograms||Standard Deviation|Mean
1439240|NCT00941668|Primary|Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours|Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)|4 weeks||||Micrograms||Standard Deviation|Mean
1441679|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mmHg||Standard Deviation|Mean
1439241|NCT00941655|Secondary|Patterns of Disease Recurrence Between the Two Therapeutic Approaches and Their Clinical Implications|Compare surgery + heated intraperitoneal chemotherapy + systemic chemotherapy; and systemic chemotherapy alone to determine how each group responds clinically.|up to 3 years|Zero participants were analyzed because data collected was insufficient due to the small sample size (I.e. too few patients to analyze) to make any comparisons that might be interpretable and subject to statistical rigor. Outcome will not be explored further.||||||
1439242|NCT00941655|Secondary|Quality of Life (QOL) Parameters Between the Two Study Groups|QOL tools Functional Assessment of Cancer Therapy - Gastric cancer (FACT-Ga) specifically developed for the assessment of QOL in gastric cancer patients.|up to 3 years|Zero participants were analyzed because data collected was insufficient due to the small sample size (I.e. too few patients to analyze) to make any comparisons that might be interpretable and subject to statistical rigor. Outcome will not be explored further.||||||
1439243|NCT00941655|Secondary|Median Duration of Cytoreduction Surgery and Heated Intraperitoneal Chemotherapy (HIPEC)|Time it takes to perform this complex surgery and HIPEC to reduce tumor burden overall in this disease.|up to 12 hours||||hours||Full Range|Median
1439244|NCT00941655|Secondary|Median Hospital Stay After Initial Surgery|Recuperation period following complex surgery for this disease.|1-10 weeks||||Days||Full Range|Median
1439245|NCT00941655|Secondary|Median Blood Loss During Surgery|Blood loss during surgery is related to complexity of the operation and via that to the stage of disease (more tumor to be cytoreduced, more blood loss).|Day 1||||ml||Full Range|Median
1439246|NCT00941655|Secondary|Completeness of Cytoreduction (CCR) Score|CCR is assessed by Sugarbaker's criteria. CCR-0 is no residual tumor. CCR-1 is no residual nodules greater than 2.5 mm in diameter, CCR-2 is no residual nodules greater than 25 mm, and CCR-3 is residual nodules greater than 25 mm.|Day 1||||Scores on a scale|||Number
1439247|NCT00941655|Secondary|Gillys Stage Before and After Surgery|Gillys stage measures the completeness of the cytoreduction and is recorded before and after surgery. It is used to classify disease burden and determine prognosis. Stage 0 is no macroscopic signs of disease, stage 1 is nodules >5mm in one part of the abdomen, stage 2 is nodules >5 mm throughout the abdomen, stage 3 is nodules 5mm to 2 cm, and stage 4 is nodules < 2 cm.|Day 1||||Stage|||Number
1439248|NCT00941655|Secondary|12 Months Disease Free Survival (DFS)|Participants who were alive and disease free at 12 months. DFS was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was disappearance of all target lesions. Partial response was at least a 30% decrease in target lesions. Progression was at least a 20% increase in target lesions and stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|12 months||||Participants|||Count of Participants
1439249|NCT00941655|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|40.5 months||||Participants|||Count of Participants
1439250|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II|Time between the first day of treatment and the date of death|12 weeks up to 3 years|Patient #3 - alive 17 months at time of study closure; patient 5 alive 6 months at time of study closure; patient 13 alive 8 months at time of study closure; patients 10,12 randomized but withdrew/no treatment; patient 14 randomized but did not return for treatment and lost to follow up. Patient #16 was lost to follow up after being randomized.|||Months|||Number
1439251|NCT00941655|Primary|Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I|Time between the first day of treatment and the date of death.|12 weeks up to 3 years|Patient #7 - alive 14 months at time of study closure; patient 11 alive 12 months at time of study closure; patient 15 expired following surgery.|||Months|||Number
1439252|NCT00941603|Secondary|Change From Baseline in Direct Non-HDL-C at Week 8|The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.|||Percent change||Standard Error|Least Squares Mean
1439253|NCT00941603|Primary|Change From Baseline in Direct LDL-C at Week 8|The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.|Baseline and Week 8|Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.|||Percent change||Standard Error|Least Squares Mean
1439254|NCT00941330|Secondary|Response Rate by Imaging|"Arm A and recurrence score ≤10: Patients will have radiologic assessment of response to exemestane by clinical examination every 4 weeks and by radiologic assessment every 2 months. Once maximal response has been achieved (stable disease for 2 months after at least 4 months of treatment by radiologic assessment) or when 12 months of therapy has been given patients will proceed to surgery.~Arm B: Patients will be assessed for surgery after 6 cycles of docetaxel and cytoxan (TC) (18 weeks).~On arm A and recurrence score ≤10 patients will be reassessed for surgery once maximal radiologic response is achieved.~On arm B, patients will be reassessed for surgery after 6 cycles of TC (18 weeks).~Radiographic images were analyzed by a breast radiologist who looked at preoperative and postoperative breast mass imaging. If mass was smaller/less extensive, it was considered improved."|Every 2 months up to 3 years|Data were not available for 5 patients (4 withdrew and 1 did not have surgery).|||Participants|||Count of Participants
1439255|NCT00941330|Primary|Pathologic Complete Response|"Patients must have measurable disease by clinical examination.~Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.~If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists."|At time of definitive surgery|One patient in Arm B did not have surgery.|||Participants|||Count of Participants
1439375|NCT00939809|Primary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Every cycle during treatment (average collection time = 4 months)|Eligible and Treated Patients|||Participants|||Count of Participants
1439256|NCT00941304|Secondary|Change From Baseline in Cognitive Assessment Using CNS-VS|"Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that lower score is better”, otherwise higher scores are better."|Baseline (screening), 2 hours 15 minutes postdose|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||Score||Standard Deviation|Mean
1439257|NCT00941304|Secondary|Percentage of Participants With “Excellent” Investigator Global Rating of Study Drug|Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to “Overall, how would you rate the study medication for this subject?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||percentage of participants|||Number
1439258|NCT00941304|Secondary|Percentage of Participants Reporting a Global Rating of Study Drug as “Excellent”|Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to “Overall, how would you rate the study medication you received for pain?”|8 hours and 24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||percentage of participants|||Number
1439259|NCT00941304|Secondary|Duration of Analgesia|Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration.|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||hours||95% Confidence Interval|Median
1439260|NCT00941304|Secondary|Onset of Analgesia|Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration.|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||hours||95% Confidence Interval|Median
1439261|NCT00941304|Secondary|Peak Pain Relief|Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
1439262|NCT00941304|Secondary|Peak Pain Intensity Difference|The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|24 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
1439263|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 2 Hours|Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?” PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|2 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
1439264|NCT00941304|Secondary|Sum of Pain Relief and Intensity Differences Over 8 Hours|Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?” PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
1439265|NCT00941304|Secondary|Total Pain Relief Over 8 Hours|Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to “How much relief have you had from your starting pain?”|8 hours|Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
1439266|NCT00941304|Primary|Sum of Pain Intensity Difference From Baseline to 8 Hours|Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to “What is your pain level at this time?”|Baseline, 8 hours|Analysis based on intent-to-treat (ITT) population; all subjects who received study drug and provided at least 1 post-dose assessment.|||units on a scale||Standard Deviation|Mean
1439267|NCT00941070|Post-Hoc|Progression Free Survival by Smoking Status|Percent of patients that were progression free by smoking status|at 18 months from study entry||||percentage of paticipants||95% Confidence Interval|Number
1439268|NCT00941070|Secondary|Progression Free Survival by HPV Subtype|Tabular descriptive data will be presented. HPV sub-type will be associated with treatment related toxicity, clinical response, PET metabolic response, and overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation will be used. Tests of equivalence of the estimates will be compared using the Wilcoxon long-rank test using a threshold for statistical significance of P 0.05. Cox proportional hazards regression models will be used in multivariate analyses.|Baseline||||percentage of patients||95% Confidence Interval|Number
1439269|NCT00941070|Secondary|Change in Smoking Behavior, Assessed Using the Smoking Questionnaire and Cessation Counseling||18 months from study entry||||participants|||Number
1439271|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Up to 5 years|Data were not collected as the study was terminated prior to the time period for collection.||||||
1439272|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|3 months post-treatment|Patients that completed 3-month 18F-FDG PET/CT|||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
1439273|NCT00941070|Secondary|PET/CT Scan Metabolic Activity|Descriptive tabular data reporting mean, standard deviation, minimum, maximum provided by metabolic response cohort. Status of 3-month post-treatment metabolic response associated with clinical response measured by RECIST criteria and with overall clinical outcome. Kaplan-Meier (product-limit) method of survival estimation used. Tests of equivalence of the estimates compared using the Wilcoxon long-rank test using P 0.05. Cox proportional hazards regression models used in multivariate analyses.|Baseline (pre-therapy)|Patients that completed the 3-month 18F-FDG PET/CT|||Standard Uptake Value (SUV)||Inter-Quartile Range|Median
1439274|NCT00941070|Secondary|Progression-free Survival|Percentage of patients that did not have disease progression. Estimates of progression-free survival will be computed using the product-limit estimate of Kaplan and Meier.|at 18 months from study entry|Patients that completed the the 3-month 18F-FDG PET/CT.|||percentage of patients||95% Confidence Interval|Number
1439275|NCT00941070|Secondary|Percent of Patients With Incidence of Grade 2 or Higher Gastrointestinal and Genitourinary Toxicity, Assessed Using CTCAE v3.0 Until December 31, 2010 and CTCAE v4.0 Beginning January 1, 2011|Information will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Frequency tables will be constructed to summarize observed incidence by severity and type of toxicity.|After 5 weeks of radiation therapy|All patients who receive at least one dose of Triapine® and cisplatin treatment.|||percentage of patients|||Number
1439276|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|three month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.|||participants|||Number
1439277|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|one month follow up assessment|Patients that completed the the 3-month 18F-FDG PET/CT. One patient died from an unrelated health event after completing radiation and experimental chemotherapy and was excluded from analyse.|||participants|||Number
1439278|NCT00941070|Secondary|Clinical and Objective Response Assignment|Number of patients with a complete clinical responses defined as disappearance of all target lesions. A complete metabolic response on PET/CT will be defined as absence of abnormal FDG uptake at sites of abnormal FDG uptake noted on pre-treatment FDG-PET study.|post therapy at 3 months|Patients that completed the 3-month F-18 FDG study.|||participants|||Number
1439279|NCT00941070|Primary|Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.|To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.|post therapy at 3 months|1 patient was non-compliant and received no therapy. Pt was excluded from analyses. 1 patient died from an unrelated health event after completing radiation and experimental chemotherapy and did not undergo 3-month F-18 FDG study.|||Standard uptake value (SUV)||Inter-Quartile Range|Median
1439280|NCT00941031|Secondary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously With Respect Participants Who Reported Either an IGA 0 or 1 After 12 Weeks of Treatment, Compared to Placebo|The investigator’s global assessment (IGA) was used to evaluate overall psoriatic disease, with scores ranging from 0 (clear) to 5 (very severe disease). Treatment success was defined as patients who achieved IGA 0 or 1 and improvement of at least 2 points on the IGA scale compared to baseline. The IGA rating score for involvement of hands and feet ranged from 0 (clear) to 4 (severe).|13 weeks|Full analysis set|||Participants achieving goal|||Number
1439281|NCT00941031|Secondary|The Efficacy of Two Maintenance Regimens of AIN457 With Respect to PASI 75 Achievement at Least Once From Week 21 to 29||week 21 to 29|(Full analysis set, LOCF)|||Participants achieving goal|||Number
1439282|NCT00941031|Primary|The Efficacy of Three Induction Regimens of AIN457 Administered Subcutaneously in Patients With Moderate to Severe Chronic Plaque-type Psoriasis With Respect to PASI 75 Achievement After 12 Weeks of Treatment, Compared to Placebo.|Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment|13 weeks|(Full analysis set, LOCF) Number (%) of patients achieving PASI 50, PASI 75, PASI 90, by visit and induction treatment|||Participants achieving goal|||Number
1439283|NCT00940992|Primary|Change in Inflammatory Lesion Counts From Baseline|The LS mean changes from Baseline in inflammatory lesion count at Week 12.|Baseline to Week 12 / end of treatment||||Inflammatory lesions||95% Confidence Interval|Least Squares Mean
1439413|NCT00939484|Secondary|Pharmacokinetic Parameters of Vismodegib, CSF Penetration|The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.|up to 12 month|The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data|||ratio||Full Range|Median
1439284|NCT00940992|Primary|Investigator Global Assessment (IGA) Improvement From Baseline|The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).|Baseline to Week 12 / end of treatment||||percentage of subjects|||Number
1439285|NCT00940927|Primary|Effect Maximum (Emax)|Maximum percentage of predicted FEV1 effect|15 minutes after each dose||||percentage of predicted|||Number
1439286|NCT00940927|Primary|Effective Dose 50% (ED50)|ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol|15 minutes after each dose||||ug|||Number
1439287|NCT00940901|Primary|Greater Than or Equal to a 50% Reduction in Priapic Episodes|"A Priapism sexual activity log was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes."|change between 8 weeks post intervention and 16 weeks post intervention|3 participants from the Phase 1 Sildenafil group were lost to follow up during the second phase; 2 individuals from the Phase 1 Placebo then sildenafil group were lost to follow up during the second phase.|||Number of participants|||Number
1439288|NCT00940901|Primary|Greater Than or Equal to a 50% Reduction in Priapic Episodes|"A Priapism sexual activity log was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes."|change between baseline and 8 weeks post intervention|Intention to treat analysis.|||Number of participants|||Number
1439289|NCT00940888|Primary|Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector||5 years||||percentage of patients||90% Confidence Interval|Number
1439290|NCT00940888|Primary|Right Ventricle (RV) Bipolar Capture Thresholds||5 years|Study participants with RV bipolar capture threshold at the 5 year follow up visit.|||Volts||90% Confidence Interval|Mean
1439291|NCT00940875|Secondary|Duration of Response|Duration of response was defined as the time between the first documentation of CR or PR (whichever status was recorded first as assessed by the RECIST V 1.0) until the date of documented disease progression or death. Participants with no documented disease progression or death after confirmed CR or PR were censored at the date of the last tumor assessment or last date of follow-up when the participant was known to be progression free, whichever was last.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|Data could not be summarized to be included in the data table because there are too few events to calculate a median and confidence intervals.||||||
1439292|NCT00940875|Secondary|Overall Survival (OS)|OS was defined as the median time, in weeks, between randomization and death due to any cause. Participants without documented death were censored at the last date recorded in the drug log, or the last date of follow-up the participant was known to be alive, whichever was last. Participants without a post-BL assessment who were known to be alive were censored at the date of randomization. OS was estimated using Kaplan-Meier methodology.|BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS|||weeks||95% Confidence Interval|Median
1439293|NCT00940875|Secondary|Percentage of Participants Who Died||BL, Days 1, 8, and 15 of Cycles 1-6 (28-day cycles), every 28 days thereafter until death, participant withdrawal, or study termination up to 2 years.|FAS|||percentage of participants|||Number
1439294|NCT00940875|Secondary|Percentage of Participants With Non-Progression at Weeks 8 and 16|Non-progression was defined as CR, PR, or stable disease according to RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD recorded since the start of treatment. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above the normal limits. The 95% CI for one-sample binomial was determined using the Pearson-Clopper method.|Weeks 8 and 16|FAS|||percentage of participants||95% Confidence Interval|Number
1439295|NCT00940875|Primary|PFS|The median time, in weeks, between randomization and PFS event. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-BL tumor assessment who were known to be alive were censored at the date of randomization. PFS was estimated by using Kaplan-Meier methodology.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (up to 2 years)|FAS|||weeks||95% Confidence Interval|Median
1439296|NCT00940875|Secondary|Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST V 1.0|As per RECIST V 1.0: for TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of TLs taking as reference the BL SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper Method.|BL, Day 22 of Cycle 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS|||percentage of participants||95% Confidence Interval|Number
1439311|NCT00940537|Primary|The Reproducibility of the Hepatic Triglyceride Content Measurement by MRS.|We compared three 1H-Magnetic Resonance Spectroscopy sequences: A Standard Siemens sequence, and an optimized sequence with either breath-holds or free-breathing. Repeat scans were done with the subject briefly removed from and returned to the scanner between scans. The results given are coefficients of variation of the triglyceride signal divided by the water signal.|6 months||||coefficient of variation||Standard Error|Mean
1439913|NCT00936208|Primary|Change in Systolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24|||mmHg||Standard Deviation|Mean
1439297|NCT00940875|Primary|Percentage of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from randomization to the date of first documentation of progressive disease (PD), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.0, or date of death from any cause. PD was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants without documented PD were censored at the date of last tumor assessment, the last date recorded in the drug log, or the last date of follow-up the participant was known to be progression free, whichever was last. Participants without a post-Baseline (BL) tumor assessment who were known to be alive were censored at the date of randomization.|BL, Day 22 of Cycles 2, 4, and 6 (28-day cycles), every 2 months thereafter until disease progression, participant withdrawal, or study termination (12 months after randomization of the last participant).|FAS|||percentage of participants|||Number
1439298|NCT00940823|Secondary|Number of Participants With Interventions After Surgery||5 years||||Participants|||Count of Participants
1439299|NCT00940823|Secondary|Number of Participants With Complications During or After Surgery||5 years||||Participants|||Count of Participants
1439300|NCT00940823|Secondary|LogMAR Snellen Visual Acuity|Visual acuity (VA) was tested monocularly (one eye at a time) using the manifest refraction adjusted for optical infinity using a standard Snellen Visual Acuity chart at 20 feet. Normal vision, or 20/20 vision, means that the participant can see at 20 feet what a healthy control can also see at 20 feet. Legal blindness, or 20/200 vision, means the participant can see at 20 feet what a healthy control can see at 200 feet. Hence, an increasing denominator implies visual impairment. Counting fingers was designated as 20/2000 vision, hand motions was 20/16000, light perception was 20/32000 and no light perception was 20/64000. To allow for appropriate statistical analysis, logMAR Snellen Visual Acuity was calculated using the formula: -logMAR (Snellen Acuity). This means that normal vision (20/20) would correspond to a value of 0, legal blindness (20/200) would correspond to a value of 1, and no light perception (20/64000) would correspond to 3.5.|5 years||||logMAR units on a scale||Standard Deviation|Mean
1439301|NCT00940823|Secondary|Anti-glaucoma Medications||5 years||||glaucoma medications||Standard Deviation|Mean
1439302|NCT00940823|Secondary|Intraocular Pressure (IOP)||5 years||||mmHg||Standard Deviation|Mean
1439303|NCT00940823|Primary|Number of Participants With Surgical Failure (Composite Measure)|"IOP out of target range (5-18 mmHg inclusive) or <20% reduction from baseline for 2 consecutive visits after 3 months.~De novo glaucoma surgery required (e.g., cyclodestructive procedure, additional tube shunt).~Removal of the implant.~Severe vision loss related to the surgery (endophthalmitis, suprachoroidal hemorrhage with vision loss, enucleation, evisceration, or phthisis bulbi) or progression to no light perception for any reason."|5 years||||participants|||Number
1439304|NCT00940589|Secondary|Change From Baseline to 24 Weeks in MMSE|The Mini Mental State Examination (MMSE) is a brief assessment instrument used to assess cognitive function in elderly patients. The MMSE can be used to screen for cognitive impairment and as a measurement of cognition over time and with pharmacologic treatment. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention: the maximum score is 21. The second section tests the ability of the patient to name objects, follow verbal and written commands, write a sentence, and copy figures: the maximum score is 9. The scoring range for the MMSE is 0-30. Higher score represents better performance. MMSE was measured at base line and at end of treatment after 24 weeks.|24 weeks||||Scores on a scale||Standard Deviation|Mean
1439305|NCT00940589|Secondary|Change From Baseline to 24 Weeks in iADL|Instrumental Activities of Daily Living (iADL). The scale rates activities that represent key life tasks that people need to manage. These tasks are valuable for evaluating persons with early-stage disease, both to assess the level of disease and to determine the person’s ability to care for himself or herself. Scores of 0 or 1 are given to every task (Bathing, Dressing, Tolieting, transferring, Continence and Feeding) to a total score of 6. , while 0 represents a patient who is very dependent and 6 represents patient who is independent. iADL was measured at base line and at end of treatment after 24 weeks.|24 weeks||||Scores on a scale||Standard Deviation|Mean
1439306|NCT00940589|Primary|Change From Baseline to 24 Weeks in ADAS-cog|ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a cognitive testing instrument used in clinical trials. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD. The test comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline. ADAS-cog was measured at base line and at end of treatment after 24 weeks.|24 weeks||||Scores on a scale||Standard Deviation|Mean
1439307|NCT00940576|Primary|Score of Crohn´s Disease and/or Ulcerative Colitis|score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), < 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.|8 weeks||||units on a scale||Standard Deviation|Mean
1439308|NCT00940576|Secondary|Extra-intestinal Pain|The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).|8 weeks||||Percentage of days with pain||Standard Deviation|Mean
1439309|NCT00940537|Secondary|T2 (Spin-spin Relaxation Time) Ratios of Triglyceride/Water|T2 (spin-spin relaxation time) ratios of triglyceride/water using optimized PRESS sequences|baseline cross-sectional measurements|This analysis was per protocol.|||ratio||Standard Deviation|Mean
1439310|NCT00940537|Secondary|The Hepatic Triglyceride Content Pre- and Post-prandial.|We compared the intrahepatic triglyceride content in subjects after a 12 hour fast and 2 hours after eating a high fat, high carbohydrate meal. The measure reported here is for the pre and post prandial results given as the ratio of triglyceride signal to water signal. After showing its reliability, we chose to use the results from the optimized breath-hold sequence.|after a 12 hour fast and 2 hours post-prandial||||ratio||Standard Error|Mean
1439442|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Night-time Reliever Medication From run-in Period|Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks||||Number of inhalations||95% Confidence Interval|Mean
1439312|NCT00940485|Secondary|Number of Participants With Laboratory Abnormalities Which Were Captured as an Adverse Event|Participants with clinically significant laboratory abnormalities which were captured as an AE (at the >=5% threshold) were presented.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.|||Participants|||Number
1439313|NCT00940485|Secondary|Number of Participants With Incidence of Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 48|Safety set (SS) included all the participants who received at least 1 dose of study drug and who had at least undergone safety assessment once, regardless of whether the patients withdrew from the study or not.|||Participants|||Number
1439314|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Surface Antigen Change Over Time|Quantitative Hepatitis B Surface Antigen (HBsAg) results were analyzed in central lab. Values that were less than LLOQ had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBsAg calculated using ‘International Units Per Millilitre’ (IU/mL). Change in HBsAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.|||IU/ml||Standard Deviation|Mean
1439315|NCT00940485|Secondary|Quantitative Change in Mean Hepatitis B Envelope Antigen Over Time|Quantitative hepatitis B envelope antigen (HBeAg) results were analyzed in central lab. Values that were less than lower limit of quantification (LLOQ) had been replaced by LLOQ when analyzed, e.g. <1000 was replaced by 1000 and <0.2 was replaced by 0.2. Quantitative HBeAg value unit was calculated using ‘Paul Ehrlich Institute units per millilitre’ (PEIU/ml). Change in HBeAg was analysed at Weeks 0, 8, 12, 24, 36, and 48.|Up to Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug. Maximum participants available at particular time point were analysed.|||PEIU/ml)||Standard Deviation|Mean
1439316|NCT00940485|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase at Week 48|Normalized Alanine Aminotransferase (ALT) is defined as having a baseline ALT value > upper limit of normal (ULN), and a decrease in ALT value to ≤ ULN at the given time point.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1439317|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion at Week 48|Hepatitis B Surface Antigen (HBsAg) seroconversion was defined as loss of HBsAg and presence of anti-HBs .(antibody to Hepatitis B surface antigen)|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1439318|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Loss at Week 48|Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1439319|NCT00940485|Secondary|Percentage of Participants With Hepatitis B Virus - Deoxyribonucleic Acid <1000 Copies/ Millilitre at Week 48|Blood was collected for Hepatitis B Virus - Deoxyribonucleic Acid (HBV -DNA) and was analysed at the central laboratories using the Roche approved polymerase chain reaction (PCR) methodology at Week 48. Percentage of participants with HBV-DNA < 1000 copies/mL was reported.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1439320|NCT00940485|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen at Week 48|Loss of Hepatitis B Envelope Antigen (HBeAg) is defined as the absence of HBeAg.|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1439321|NCT00940485|Primary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion at Week 48|Hepatitis B envelope Antigen (HBeAg) seroconversion was defined as the absence of HBeAg and the presence of antibody to Hepatitis B envelope antigen (anti-HBe).|At Week 48|Full analysis set included all patients who were randomized and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1439322|NCT00940446|Secondary|Participants With Wound Complications - Hematoma|Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.|up to 6 weeks post-op||||participants|||Number
1439323|NCT00940446|Primary|Participants With Incisional Drainage, Swelling or Gaps of Incision|Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.|Discharge from initial hospital stay (2-5 days post-op)||||participants|||Number
1439324|NCT00940290|Primary|Change in Behavior in Physicians Attitude Towards a Decision to Give a Medication|"A fictitious clinical case of a child with acute diarrhea was presented. The physician read the case and then answered the question would you recommend racecadotril to this patient? A zero to 10 visual-analog scale and a Likert scale were used to measure the decision of the physician related to the clinical case presented (from zero=definitely no to 10=definitely yes). Mean differences before-after and among groups were measured on the 10 centimeters scale."|One day||||Mean change in centimeters||95% Confidence Interval|Mean
1439336|NCT00940017|Primary|Concentration Ratio in ELF to Plasma|Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Subjects randomized to a single BAL procedure timepoint; bronchoscopy and BAL done for 5 different subjects at each timepoint.|||ratio||Standard Deviation|Mean
1439325|NCT00940108|Secondary|Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination|Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.|During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439326|NCT00940108|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439327|NCT00940108|Secondary|Duration of Solicited AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
1439328|NCT00940108|Secondary|Duration of Solicited AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
1439329|NCT00940108|Secondary|Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.|During the 7 days after each vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439330|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439331|NCT00940108|Primary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439332|NCT00940108|Primary|GMFI in the HI Antibody Titre After the Second Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1439333|NCT00940108|Primary|Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination|GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1439334|NCT00940108|Primary|HI Antibody Titre Seroconversion Rate After the Second Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439335|NCT00940108|Primary|Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination|HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439914|NCT00936208|Primary|Change in Diastolic Blood Pressure From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value.|Baseline and Week 24|Full Analysis Set (FAS): Patients with Blood Pressure data available at baseline and at week 24|||mmHg||Standard Deviation|Mean
1439337|NCT00940017|Primary|Overall Drug Penetration Ratio in ELF|ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average ELF to plasma ratio|||Number
1439338|NCT00940017|Primary|AM: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in AM did not allow calculation of t1/2; not analyzed.|||hours|||Number
1439339|NCT00940017|Primary|AM: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug*hr/mL)|||Number
1439340|NCT00940017|Primary|AM: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. AM collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||hours|||Number
1439341|NCT00940017|Primary|Alveolar Macrophages (AM): Cmax|Cmax = maximum observed plasma concentration; observed directly from the data. AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug/mL)|||Number
1439342|NCT00940017|Primary|ELF PK: t1/2|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects. Data in ELF did not allow calculation of t1/2; not analyzed.|||hours|||Number
1439343|NCT00940017|Primary|ELF PK: AUCtau|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole. ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug*hr/mL)|||Number
1439344|NCT00940017|Primary|ELF PK: Tmax|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. ELF collected by bronchoscopy and BAL on Day 3.|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||hours|||Number
1439345|NCT00940017|Primary|Epithelial Lining Fluid (ELF) PK: Cmax|Cmax=maximum observed plasma concentration. ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL]. Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected. Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).|4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; summary parameters derived using average data for all subjects.|||average concentration (ug/mL)|||Number
1439346|NCT00940017|Primary|Plasma PK: Volume of Distribution at Steady-state (Vss)|Vss = volume of distribution at steady-state; measured as liters (L). Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]). MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean.|||L||Standard Deviation|Mean
1439347|NCT00940017|Primary|Plasma PK: Total Clearance (CL Total)|CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population|||mL/min||Standard Deviation|Mean
1439348|NCT00940017|Primary|Plasma PK: Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population; (n) = number of subjects contributing to the mean|||hours||Standard Deviation|Mean
1439349|NCT00940017|Primary|Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)|AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL). Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest.|||ug*hr/mL||Standard Deviation|Mean
1439350|NCT00940017|Primary|Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence. Collected on Day 3.|100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion|PK parameter analysis population|||hours||Full Range|Median
1439354|NCT00939991|Secondary|Phase II: Median Progression-free Survival (PFS)|Phase II: Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|3 years||||months||95% Confidence Interval|Median
1439355|NCT00939991|Secondary|Phase II: Radiographic Response.|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria. A confirmation of response was not required. Complete Response (CR) was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments were done at baseline, the end of the first cycle (4 weeks), then the end of every second cycle (every 8 weeks) thereafter.|3 years||||percentage of participants||95% Confidence Interval|Number
1439356|NCT00939991|Primary|Phase II: 6-month Progression-free Survival (PFS)|Phase II: Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to RANO criteria, or to death due to any cause. Per RANO, progression is a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.|6 months||||percentage of participants||95% Confidence Interval|Number
1439357|NCT00939991|Primary|Phase I: Determination of the Maximum Tolerated Dose (MTD)|The MTD is based upon dose-limiting toxicities (DLTs) experienced during Cycle 1 of treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with at least two patients experiencing DLT at the next higher dose level. Using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, DLTs are defined as: Grade 4 neutropenia lasting greater than 5 days; Grade 3 thrombocytopenia; the occurrence of non-hematologic Grade 3 or greater drug-related adverse events excluding Grade ≥ 3 elevation in alkaline phosphatase, Grade ≥ 3 nausea or vomiting unless occurring despite the use of standard anti-emetics or Grade 3 diarrhea unless occurring despite standard anti-diarrheal therapy; > 14 day delay to re-treat due to failure to resolve drug-related toxicity to re-treatment criteria or pre-treatment baseline.|Cycle 1 (28 days)||||mg|||Number
1439358|NCT00939952|Primary|Residual Drug in Peritoneal Cavity After 1st Exchange||6h||||mg||Standard Deviation|Mean
1439359|NCT00939952|Primary|k31|1st order intercompartmental rate constant peritoneal cavity to central|12h||||h^(-1)||Standard Deviation|Mean
1439360|NCT00939952|Primary|k13|1st order intercompartmental rate constant from central to peritoneal cavity|12h||||h^(-1)||Standard Deviation|Mean
1439361|NCT00939952|Primary|k21|1st order intercompartmental rate constant from peripheral to central compartment|12h||||h^(-1)||Standard Deviation|Mean
1439362|NCT00939952|Primary|k12|1st order intercompartmental rate constant between central and peripheral compartments|12h||||h^(-1)||Standard Deviation|Mean
1439363|NCT00939952|Primary|Clearance (CL)|population PK clearance|12h||||Liters/hour (L/h)||Standard Deviation|Mean
1439364|NCT00939952|Primary|Volume of Distribution, Central Compartment (Vc)|Population PK|12h||||Liters (L)||Standard Deviation|Mean
1439365|NCT00939900|Secondary|Time to Total Arthroplasty or Joint Preserving Surgery||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
1439366|NCT00939900|Secondary|Time to Collapse of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
1439367|NCT00939900|Secondary|Change of HHS (Harris Hip Scores), WOMAC Score, SF-36||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
1439368|NCT00939900|Secondary|Collpase Rate of Femoral Head||Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)|||||||
1439369|NCT00939900|Primary|Number of Participants With Femoral Head Collapse Within 24 Months||Measurements were done at 6, 12, 24 months||||participants|||Number
1439370|NCT00939874|Secondary|Percentage of Participants With HIV Viral Load <50 Copies/mL|Plasma HIV viral load remained <50 copies/mL|from Baseline to Week 96|Week 96 data were available for 32 completed participants|||percentage of participants|||Number
1439371|NCT00939874|Primary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips|Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96|from Baseline to Weeks 48 and 96|Week 48 data were available for 37 completed participants and Week 96 data were available for 32 completed participants. Fifteen of the enrolled 52 participants were screen failures.|||percent change||95% Confidence Interval|Mean
1439372|NCT00939809|Secondary|Biomarkers of Drug Effect on Peripheral Blood Mononuclear Cells (PBMCs)|Note: due to the limited activity of this agent, it was decided not to expend resources assaying the PBMCs.|Day 1 prior to dosing; Day 2 prior to dosing and 4-hour post dosing; Day 8 prior to dosing.|||||||
1439373|NCT00939809|Secondary|Overall Survival||Every other cycle, up to 5 years|Eligible and treated participants|||months||95% Confidence Interval|Median
1439374|NCT00939809|Secondary|Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||months||95% Confidence Interval|Median
1441680|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mmHg||Standard Deviation|Mean
1439376|NCT00939809|Primary|Tumor Response|"Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
1439377|NCT00939809|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.~CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response."|Scans to assess progression were done every other cycle for the first 6 months.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
1439378|NCT00939796|Secondary|Tube Retention|Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).|two weeks post-procedure||||retained tubes|Participants||Number
1439379|NCT00939796|Secondary|Cross-Over to Manual Myringotomy and Tube Placement|Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.|at procedure visit||||number of ears|Participants||Number
1439380|NCT00939796|Primary|Device Success|Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).|At procedure visit|All TTDS devices attempted|||devices|Participants||Number
1439381|NCT00939783|Secondary|Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >450 to <=480, >480 to <=500 and >500 msec, increase of >30 to <=60 and >60 msec for QT interval corrected using Fridericia's formula (QTcF).|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.|||Percentage of participants|||Number
1439382|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if observed value was more than or less than X times upper limit of normal (ULN) or lower limit of normal (LLN); X=specified in categories of each parameter in measured values section. For urinalysis abnormality was reported if result was >=1 in qualitative test of all parameters except red and white blood cells which were reported if result was >=6, indicating levels in urine were abnormal. Urine pH abnormality reported if >8 and urine specific gravity abnormality if <1.003 or >1.030.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular laboratory parameter.|||Percentage of participants|||Number
1439383|NCT00939783|Secondary|Percentage of Participants With Abnormal Clinically Significant Vital Signs|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline for systolic BP; absolute diastolic BP <50 mmHg with maximum increase or decrease of >=20 mmHg from baseline and absolute heart rate values <40 beats per minute (bpm), >120 bpm for supine or sitting measurement, >140 bpm for standing measurement.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.|||Percentage of participants|||Number
1439384|NCT00939783|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 65 (end of treatment)|Safety analysis set included all the participants who received at least one dose of study medication, including partial doses.|||Percentage of participants|||Number
1439385|NCT00939731|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L||Standard Deviation|Geometric Mean
1441681|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mmHg||Standard Deviation|Mean
1439386|NCT00939731|Secondary|Apparent Oral Clearance (CL/F)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1439387|NCT00939731|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1439388|NCT00939731|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1439389|NCT00939731|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Standard Deviation|Mean
1439390|NCT00939731|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hrs post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
1439391|NCT00939731|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, 84 and 96 hours (hrs) post PF-02341066 dose in period 1 and additional 168 hrs post PF-02341066 dose in period 2|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1439392|NCT00939705|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.|||ng h / ml|Participants|Standard Deviation|Mean
1439393|NCT00939705|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.|||ng h / ml|Participants|Standard Deviation|Mean
1439394|NCT00939705|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.|Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.|||ng / ml|Participants|Standard Deviation|Mean
1439395|NCT00939692|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.||||ng·h/mL||Standard Deviation|Mean
1439396|NCT00939692|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.||||mcg*hr/mL||Standard Deviation|Mean
1439397|NCT00939692|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.||||ng/ml||Standard Deviation|Mean
1439398|NCT00939627|Other Pre-specified|Quality of Life|Quality of Life Survey results.|up to 3 years|Data were not collected as The Quality of Life survey instrument was not completed by study participants..||||||
1439399|NCT00939627|Secondary|Overall Survival Associated With Immunomodulatory Cytokines|Twelve immunomodulatory cytokines were selected based on previous a feasibility study and detected using multiplex Luminex bead assays from patient's plasma. One cytokines, HGF, was eliminated due to extremely low expression. Three representative cytokines, TGF-beta 1, IL-8 and VEGF were to be evaluated for association with survival due to clustering.|Pre-therapy, up to about 42 months (follow-up for overall survival)|Data were not collected due to an insufficient amount of tumor tissue available.||||||
1439400|NCT00939627|Secondary|Gene Expression Levels|Formalin-fixed, paraffin-embedded (FFPE) tumors were collected. The FFPE tumors were to be evaluated for p16 expression using immunohistochemistry staining with antibody. Gene Expression Levels (positive when >70% cells stained, otherwise negative) were to be described using frequencies.|Pre-therapy|Due to an insufficient amount of tumor tissue available to complete planned analysis, this analysis was abandoned.||||||
1439401|NCT00939627|Secondary|Number of Participants With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death|On-study date to 30 days following final dose of study drug|Total number of patients reported with any toxicity. Because not all patients experience a toxicity, and some experience more than one; the number of patients analyzed does not coincide with the number of patients on study.|||participants|||Number
1439402|NCT00939627|Secondary|Overall Survival (OS)|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details)|On-study date to date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||months||95% Confidence Interval|Median
1439403|NCT00939627|Secondary|Best Response|"Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD.~Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD."|On-treatment date to date of disease progression (assessed up to 3 years)|All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.|||participants|||Number
1439404|NCT00939627|Primary|Progression Free Survival (PFS)|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|On‐study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off-study date or last known alive date.|||months||95% Confidence Interval|Median
1439405|NCT00939562|Primary|Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Doxycycline|AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity.|0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|PK|||ug*hr/mL||Standard Deviation|Mean
1439406|NCT00939562|Primary|Maximum Plasma Concentration (Cmax) of Doxycycline||0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours postdose.|The pharmacokinetic (PK) concentration population was defined as all subjects randomized and treated who had at least 1 concentration in at least 1 treatment period.|||ug/mL||Standard Deviation|Mean
1439407|NCT00939536|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||mcg*hr/mL||Standard Deviation|Mean
1439408|NCT00939536|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||mcg*hr/mL||Standard Deviation|Mean
1439409|NCT00939536|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng/ml||Standard Deviation|Mean
1439410|NCT00939510|Primary|RECIST-defined Measurable Disease|Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks|every 8 weeks and at end of treatment|12 patients had RECIST-defined measurable disease. One patient came off study early for toxicity and therefore was not evaluable.|||participants|||Number
1439411|NCT00939510|Secondary|Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study|The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.|every 28 days for first 3 cycles, end of study|All patients that received treatment|||participants|||Number
1439412|NCT00939510|Primary|Number of Patients With a PSA Response|Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.|reevaluated for response every eight weeks|All patients that received treatment.|||participants|||Number
1439414|NCT00939484|Secondary|Duration of Objective Response|The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.|From start of treatment up to 2 years|Patients with sustained objective response|||months||Full Range|Median
1439415|NCT00939484|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.|From start of treatment up to 2 years||||months||95% Confidence Interval|Median
1439416|NCT00939484|Primary|Objective Response (CR+PR) Sustained for ≥ 8 Weeks|Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.|Up to 12 months||||proportion of participants||95% Confidence Interval|Number
1439417|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SNOT-20)|Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).|||change in SNOT-20 score||Standard Deviation|Mean
1439418|NCT00939471|Secondary|Revision Rate|The number of subjects requiring revisions out of 33 subjects treated.|at 1 year||||participants|||Number
1439419|NCT00939471|Secondary|Days Out of School During the 12 Months of Follow-up|Quantitative assessment of days out of school during the 12 months of follow-up.|12 months||||days||Standard Deviation|Mean
1439420|NCT00939471|Secondary|Effectiveness of Dilation/Measured by Post-op Interventions|Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported.|12 months||||number of interventions|||Number
1439421|NCT00939471|Secondary|Effectiveness: Medication Thru 1 yr|Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.|12 months||||percentage of participants|||Number
1439422|NCT00939471|Secondary|Device Success: Ability to Access/Dilate Sinus Ostia|Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted.|12 months|intent to treat analysis|||percentage of sinuses successful|sinuses||Number
1439423|NCT00939471|Primary|Effectiveness: Change in Sinus Symptom Scores (SN-5)|Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement.|12 months|Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores).|||change in SN-5 score||Standard Deviation|Mean
1439424|NCT00939471|Primary|Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months|Number of device-related adverse events from time of procedure through 12 months post-procedure.|12 months||||number of events|||Number
1439425|NCT00939393|Primary|Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|24 weeks|Eleven (11) In-Office subjects and 10 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1439426|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|52 weeks|Sixteen (16) In-Office subjects and 24 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1439427|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|4 weeks|Six (6) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1439443|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Change in As-needed Day-time Reliever Medication From run-in Period|Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.|Baseline and 12 weeks||||Number of inhalations||95% Confidence Interval|Mean
1439428|NCT00939393|Secondary|Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 week|Five (5) In-Office subjects and 2 Operating Room subjects were missing data for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1439429|NCT00939393|Secondary|Proportion of Participants With Post-operative Sinus Infections|Investigators reported the sinus infections as secondary to chronic rhinosinusitis (CRS) or other pre-existing conditions such as allergies. The rates of these sinus infections are consistent with the disease burden of the subjects and consistent with post procedure symptomatology associated with endoscopic sinus surgery (ESS).|52 weeks||||participants|||Number
1439430|NCT00939393|Secondary|Proportion of Participants With Revisions (IO Only)|After sinus surgery, the patient may require a subsequent sinus procedure (a revision procedure) to address recurrence of disease. These revision procedures are assessed in this outcome measure.|52 weeks||||participants|||Number
1439431|NCT00939393|Secondary|Mean Number of Debridements Per Participant (IO Only)|A debridement is a procedure to remove post-surgical crusts, mucus, and fibrin from obstructed nasal and sinus cavities after functional endoscopic sinus surgery. Each physician visit in which a debridement was performed was counted as one debridement.|52 weeks||||debridements||Standard Deviation|Mean
1439432|NCT00939393|Secondary|Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)|Participants evaluated the per-procedural pain of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'no pain' and '5' represented 'intense pain'. Scores of 0 through 2 were considered ratings of no pain or pain of low intensity. The endpoint reports the proportion of participants reporting no pain or pain of low intensity.|Day 0|One (1) In-Office subject was missing data for this outcome measure.|||participants|||Number
1439433|NCT00939393|Secondary|Proportion of Participants Rating Procedure as Tolerable (IO Only)|Participants evaluated the tolerability of their balloon dilation in office (IO = In Office) procedure on a scale from zero to 5, where '0' represented 'not tolerated' and '5' represented 'highly tolerable'. Scores of 3 through 5 were consdered tolerable ratings. The endpoint reports the proportion of participants rating the procedure as tolerable.|Day 0|Eight (8) In-Office subjects were missing data for this outcome measure.|||participants|||Number
1439434|NCT00939393|Secondary|Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]|The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.|24 weeks|Eight (8) In-Office subjects and 15 Operating Room subjects were missing data for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1439435|NCT00939367|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng.hr/mL||Standard Deviation|Mean
1439436|NCT00939367|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng.hr/mL||Standard Deviation|Mean
1439437|NCT00939367|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma|plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.||||ng/mL||Standard Deviation|Mean
1439438|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks||||Percentage of days||Standard Deviation|Mean
1439439|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks||||Percentage of days||Standard Deviation|Mean
1439440|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day|The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day|Baseline and 12 weeks||||Percentage of days||Standard Deviation|Mean
1439441|NCT00939341|Secondary|Study Medication Use (Maintenance and Reliever) in Diary Cards – Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period|Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time|Baseline and 12 weeks||||Number of inhalations||Standard Deviation|Mean
1439460|NCT00939211|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose|Average diastolic blood pressure value|0, 30 min, 2 h, 4 h||||mmHg||Standard Deviation|Mean
1439444|NCT00939341|Secondary|Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline|Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
1439445|NCT00939341|Secondary|Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline|Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
1439446|NCT00939341|Secondary|Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
1439447|NCT00939341|Secondary|Change in AQLQ (S) Domain (Symptom) Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
1439448|NCT00939341|Secondary|Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline|Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
1439449|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
1439450|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
1439451|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
1439452|NCT00939341|Secondary|Change in Overall ACQ(5) Score From Baseline at Country Level (India)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
1439453|NCT00939341|Secondary|Change in ACQ(5) Score From Baseline at Country Level (China)|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks|This outcome measure is reported at individual country level only, and therefore the number of patients analyzed are less than reported in participant flow, which captures the total patients in the region.|||Units on a scale||95% Confidence Interval|Mean
1439454|NCT00939341|Primary|Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level|Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).|Baseline and 12 weeks||||Units on a scale||95% Confidence Interval|Mean
1439455|NCT00939211|Secondary|Plasma AZD9164 AUC0-24|Area under the AZD9164 plasma concentration curve|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h||||nmol*h/L||Full Range|Geometric Mean
1439456|NCT00939211|Secondary|Plasma AZD9164 Cmax|Maximum plasma concentration of AZD9164|0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h||||nmol/L||Full Range|Geometric Mean
1439457|NCT00939211|Secondary|QTcF, Average Effect Over 0 - 4 Hours Post-dose|Average QTcF value|0, 30 min, 2 h, 4 h||||ms||Standard Deviation|Mean
1439458|NCT00939211|Secondary|Heart Rate, Average Effect Over 0 - 4 Hours Post-dose|Average heart rate value|0, 30 min, 2 h, 4 h||||bpm||Standard Deviation|Mean
1439459|NCT00939211|Secondary|Pulse, Average Effect Over 0 - 4 Hours Post-dose|Average pulse value|0, 30 min, 2 h, 4 h||||bpm||Standard Deviation|Mean
1439469|NCT00939185|Secondary|Compliance|"Compliance was assessed by the following questions: Question 1: Were the pediatrician’s instructions during the treatment phase followed (i.e. dose, frequency and number of days)?; Question 2: Was it easy to understand your pediatrician's instructions regarding treatment?; and Question 3: Was the administration of this drug easier than any other previously used drug? Patients could answer either yes, no, or Not applicable (NA)."|3 to 7 days after receiving treatment|Safety population|||participants|||Number
1439470|NCT00939185|Secondary|Number of Subjects Who Withdrew From the Study||3 to 7 days after receiving treatment|Safety Population. Please refer to the participant flow and AE sections for results pertaining to tolerability.|||participants|||Number
1439471|NCT00939185|Primary|Number of Patients With Adverse Events (AEs)|All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.|3 to 7 days after receiving treatment|Safety population = Those subjects who were known to have received at least one dose of the study treatment. Subjects who were dispensed study treatment and immediately lost to follow-up were not included among those known to have been dosed.|||participants|||Number
1439472|NCT00939159|Primary|Overall Response Rate Based on the Hematologic Improvement|"Overall response rate defined by International Working Group (IWG) response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets:~absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence ."|Assessment with 28-day cycle until response, then every 3 cycles as needed, for up to 24 months|Of the seventeen participants registered, four were not treated making thirteen evaluable for response.|||Percentage of Participants|||Number
1439473|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Storage Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
1439474|NCT00939120|Secondary|International Prostate Symptoms Score, Voiding Subscore|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
1439475|NCT00939120|Secondary|International Prostate Symptoms Score (IPSS), Total|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
1439476|NCT00939120|Secondary|Patient Perception of Bladder Condition (PPBC)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
1439477|NCT00939120|Primary|Acute Urinary Retention (AUR)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||participants|||Number
1439478|NCT00939120|Primary|Urine Voided Volume (Voiding)|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||mL||Standard Error|Mean
1439479|NCT00939120|Primary|Maximum Urine Flow Rate (Qmax).|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||mL/sec||Standard Error|Mean
1439480|NCT00939120|Secondary|Overactive Bladder Questionnaire (OABq)|To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||units on a scale||Standard Error|Mean
1439481|NCT00939120|Primary|Post-void Residual (PVR) Volume|To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.|12 months|Last data point carried forward for participants who were randomized and dropped prior to study end.|||mL||Standard Error|Mean
1439482|NCT00939107|Primary|Number of Patients With Treatment Success|Treatment success was defined as a reduction of at least 5 points or an absolute score below 5 points on the 23-item modified Roland Morris Disability Questionnaire (best value: 0 points, worst value 23 points)|Two months posttreatment|Intention to treat|||participants|||Number
1439483|NCT00939107|Secondary|Cost Effectiveness||twelve months posttreatment||2010-08-31|08/2010||||
1439486|NCT00939107|Secondary|Pain|The back and leg pain questionnaire included three separate 11 point box scales comprising the following items: Low Back Pain (LBP) at the moment, the worst LBP within the past two weeks, and the average level of LBP within the last two weeks. These summed to a total score ranging from 0 points (no back or leg pain at all) to 60 points (worst possible back and leg pain on all items).|twelve months posttreatment||||Units on a scale||95% Confidence Interval|Mean
1439487|NCT00939107|Primary|Disability|Problems performing daily activities measured on the 23-item modified Roland Morris Disability Questionnaire (worst: 23 points, best:0 points).|two months after treatment|Intention to treat|||Units on a scale||95% Confidence Interval|Mean
1439488|NCT00939094|Secondary|Change in BPI-SF Pain Interference From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.|28 days||||Scores on BPI-SF pain interference||Standard Error|Least Squares Mean
1439489|NCT00939094|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.|28 days||||Scores (units) on BPI-SF pain severity||Standard Error|Least Squares Mean
1439490|NCT00939094|Secondary|Change in SF-MPQ Affective Index From Baseline to Day 28|"Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days||||Scores (units) on SF-MPQ Affective Index||Standard Deviation|Least Squares Mean
1439491|NCT00939094|Secondary|Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28|"Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|28 days||||Scores (units) on SF-MPQ Sensory Index||Standard Error|Least Squares Mean
1439492|NCT00939094|Secondary|Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” (Responder Rate) at Day 28|"PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of  much improved or very much improved Responder rate=(no. of responders/total no. of patients)*100"|28 days||||Patients|||Number
1439493|NCT00939094|Secondary|Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100|28 days||||Participants|||Number
1439494|NCT00939094|Secondary|Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28|NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100|28 days||||Participants|||Number
1439495|NCT00939094|Primary|Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment|Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.|Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)||||Scores (units) on NRS||Standard Error|Least Squares Mean
1439496|NCT00939055|Secondary|Quality of Life|Quality of life as assessed by the Impact of Weight on Quality of Life Questionnaire (IWQOL-Lite); a ≥ 10 total score improvement from baseline (screening) will represent a clinically significant improvement.|12 months|Secondary endpoint was not analyzed.||||||
1439497|NCT00939055|Primary|Weight Loss|A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI < 35.|12 month|When futility analysis was performed, only 46 out of 108 patients had reached the 12 month primary endpoint. Analysis was performed on the 29 StomaphyX-treated patients to determine whether study objectives were met. Sham (control) patients were not analyzed.|||participants|||Number
1439498|NCT00939029|Secondary|Point-prevalence Abstinence at 6 Months|7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.|week 24|intention to treat|||participants|||Number
1439499|NCT00939029|Secondary|Point-prevalence Abstinence at 3 Months|7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml|week 12|intention to treat|||participants|||Number
1439500|NCT00939029|Primary|End of Treatment (Week 8) Point Prevalence Abstinence|7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml|weeks 8|intention to treat|||participants|||Number
1439501|NCT00939003|Other Pre-specified|Number of Participants Achieving a BASDAI50 Response During the Open-label Period|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)|||participants|||Number
1439525|NCT00938964|Secondary|Change in the Cognitive Difficulties Scale|Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are “I forget errands I planned to do” and “I fail to recognize people I know.” Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439502|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS40 Response During the Open-label Period|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale of 0 to 100) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (indicated by N)|||participants|||Number
1439503|NCT00939003|Other Pre-specified|Number of Participants Achieving an ASAS20 Response During the Open-label Period|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Weeks 52, 104, and 156|Full analysis set participants with available data at each time point (as indicated by N)|||participants|||Number
1439504|NCT00939003|Secondary|Change From Baseline in SPARCC MRI Score for the Spine|"Six discovertebral units (DVU) representing the 6 most abnormal DVUs, and 3 consecutive sagittal slices at each DVU representing the most abnormal slices for that DVU were selected for scoring. Each DVU was divided into 4 quadrants and scored for the presence (1) or absence (0) of edema. The maximum score is 12 per DVU. The maximum score is 72 for 6 DVUs.~If edema was present in at least 1 quadrant of a DVU slice, it was scored for intensity and depth of the edema representing that slice:~A score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. The maximum score for intensity per slice is 1, per DVU is 3 and for 6 DVUs is 18.~A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the surface of the endplate in any quadrant. The maximum score per slice is 1, for a DVU is 3 and for 6 DVUs is 18.~The total maximum SPARCC score for all 6 DVUs is 108."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.|||units on a scale||Standard Deviation|Mean
1439505|NCT00939003|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints|"Six consecutive sacroiliac (SI) joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema using SPARCC scoring.~Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema; the maximum score is 8 per slice and maximum score for 6 SI joint slices is 48.~Intensity of edema: A score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice. The maximum score is 2 per slice and 12 for 6 slices.~A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The maximum score per slice is 2 and for 6 slices 12.~The total maximum score for all SI joints across 6 slices is 72."|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and non-missing post-baseline value were included.|||units on a scale||Standard Deviation|Mean
1439506|NCT00939003|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)|C-reactive protein (CRP) is considered an efficacy variable for the axial spondyloarthritis indication. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response. Higher levels indicate more inflammation.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline value were included. Last observation carried forward was used.|||mg/L||Standard Deviation|Mean
1439507|NCT00939003|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement.|Baseline and Week 12|Full analysis set; participants with non-missing Baseline and at least one non-missing post-baseline values were included. Last observation carried forward was used.|||units on a scale||Standard Deviation|Mean
1439526|NCT00938964|Secondary|Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)|Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., “Could you prepare your own meals?” “Could you drive a car?”). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439508|NCT00939003|Secondary|Number of Participants Achieving an ASAS5/6 Response|"ASAS5/6 response is a 20% improvement in five out of the following six domains:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hours or more duration).~Spinal mobility, measured from the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);~C-reactive protein level (lower levels indicate less inflammation)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
1439509|NCT00939003|Other Pre-specified|Number of Participants With Blood Hematology or Chemistry Values Common Toxicity Criteria Grade ≥ 3|Blood was collected for analysis at designated study visits; hematology and chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher then upper normal limit or lower than lower normal limit) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. Results for the double-blind phase phase of the study are reported through Week 12.|||participants|||Number
1439510|NCT00939003|Other Pre-specified|Number of Participants Reporting Adverse Events|Adverse events were collected at designated study visits for all participants who received at least 1 dose of study drug. The number of participants experiencing any adverse event (serious and non-serious) is summarized.|Through Week 12|All participants who received at least 1 dose of study drug. For the double-blind phase of the study, adverse events are reported through Week 12.|||participants|||Number
1439511|NCT00939003|Secondary|Number of Participants Achieving ASAS Partial Remission|"ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
1439512|NCT00939003|Secondary|Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life. The SF-36 consists of 36 questions in 8 domains (limitations in physical functioning due to health problems; limitations in usual role because of physical health problems; bodily pain; general health perceptions; vitality; limitations in social functioning because of physical or emotional problems; limitations in usual role due to emotional problems; and general mental health). Two component scores can be summarized: physical and mental; domains 1-4 comprise the physical component summary of the SF-36. A transformed summary score is calculated ranging from 0 to 100 where higher scores indicate a higher level of functioning. A positive change from Baseline score indicates an improvement.|Baseline and Week 12|Full analysis set with available data|||units on a scale||Standard Deviation|Mean
1439513|NCT00939003|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.|Baseline and Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
1439514|NCT00939003|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 10 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 units) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants’ ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set; Non-responder imputation performed.|||participants|||Number
1439527|NCT00938964|Secondary|Change in the Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL)|Duke Older Americans Resources and Services Procedures– Instrumental Activities of Daily Living (OARS-IADL): This measure contains six items that assess the ability to perform important tasks for daily living (e.g., “Could you prepare your own meals?” “Could you drive a car?”). Scores range from 6 to 24. Higher scores indicate increasing difficulty in engaging in daily activities.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439583|NCT00938639|Secondary|Frequency and Intensity of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439515|NCT00939003|Primary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response|"ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale from 0 to 100) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);~Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants’ ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Week 12|Full analysis set. Participants with missing data at Week 12 were counted as non-responders (non-responder imputation).|||participants|||Number
1439516|NCT00938964|Secondary|Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)|The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439517|NCT00938964|Secondary|Change in Neurological Function, as Measured by the Western Perioperative Neurologic Scale (WPNS)|The Western perioperative neurologic scale was designed to detect neurologic deficits after cardiac surgery. It includes 14 items classified into eight domains (mentation, speech, cranial nerve function, motor weakness, sensation and cerebellum, reflexes, and gait). Each item is scored from 0 (severe deficit) to3 (normal), and a maximum score of 42 indicates normal neurological function.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439518|NCT00938964|Secondary|Change in Study 36-Item Short Form Health Survey (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439519|NCT00938964|Secondary|Change in Study 36-Item Short Form Health Survey (SF-36)|The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36): The SF-36 was designed to measure general health status. Two scales were used: Work Activities (four items) and General Health (one item). For the work activities scale, the reported score was the sum of four questions, each with values ranging from 1 to 4, the total score could range from 4 to 16. A higher score on Work Activities indicates more health-related problems For the general health question, the patients ranked their health from Excellent (1) to poor (5), the scale ranged from 1 to 5 with 1 being best health and 5 being worst. A high score in General Health indicates poorer health state.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439520|NCT00938964|Secondary|Change in Social Activity|Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are “How often do you talk on the telephone with friends and relatives?” and “How often do you attend meetings of social groups, clubs, or civic organizations?” Scores range from 8 to 32. A lower score indicates more social activity.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439521|NCT00938964|Secondary|Change in Social Activity|Social Activity: This measure consisted of eight items that indicate the degree of social interaction. Sample items are “How often do you talk on the telephone with friends and relatives?” and “How often do you attend meetings of social groups, clubs, or civic organizations?” Scores range from 8 to 32. A lower score indicates more social activity.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439522|NCT00938964|Secondary|Change in Perceived Social Support|Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is “a special person who is around when I am in need” and “my family really tries to help me.” Choices range from “very strongly disagree” to “very strongly agree.” Items are summed for a range of 12 to 84, with a high score meaning more social support.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439523|NCT00938964|Secondary|Change in Perceived Social Support|Perceived Social Support Scale: Twelve items indicate how strongly subjects agree that there is “a special person who is around when I am in need” and “my family really tries to help me.” Choices range from “very strongly disagree” to “very strongly agree.” Items are summed for a range of 12 to 84, with a high score meaning more social support.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439524|NCT00938964|Secondary|Change in the Cognitive Difficulties Scale|Cognitive Difficulties Scale: a 39-item scale, is a self-report assessment of perceived problems in long- and short-term memory, concentration, attention, and psycho-motor coordination. Sample items are “I forget errands I planned to do” and “I fail to recognize people I know.” Scores range from 39 to 164, with higher scores indicating greater cognitive difficulty.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439528|NCT00938964|Secondary|Change in Symptom Limitations|Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439529|NCT00938964|Secondary|Change in Symptom Limitations|Symptom limitations: Patients were given a list of eight symptoms and asked to rate the degree to which the symptom limited daily activities. The symptoms were angina, shortness of breath, arthritis, back trouble, leg pains, headaches, fatigue, and other. Scores range from 8 to 32, with higher scores indicating greater limitations.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439530|NCT00938964|Secondary|Change in Spielberger State Anxiety Inventory (STAI)|Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as “I feel nervous” and “I feel worried.” These items are rated on a 4-point scale, based on how well they describe the patient’s current or typical mood, from “not at all” to “very much so.” Scores range from 20 to 80, with higher scores indicating greater anxiety.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439531|NCT00938964|Secondary|Change in Spielberger State Anxiety Inventory (STAI)|Spielberger State Anxiety Inventory (STAI): The STAI consists of two 20-item scales that measure anxiety. Representative items include statements such as “I feel nervous” and “I feel worried.” These items are rated on a 4-point scale, based on how well they describe the patient’s current or typical mood, from “not at all” to “very much so.” Scores range from 20 to 80, with higher scores indicating greater anxiety.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439532|NCT00938964|Secondary|Change in Center for Epidemiological Studies Depression Scale (CES-D)|Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as “I had crying spells” and “I felt lonely.” Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439533|NCT00938964|Secondary|Change in Center for Epidemiological Studies Depression Scale (CES-D)|Center for Epidemiological Studies Depression Scale (CES-D). The CES-D is a 20-item self-report examination designed to measure symptoms of depression. Subjects rate the degree to which they have experienced a range of symptoms of depression, such as “I had crying spells” and “I felt lonely.” Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. Scores greater than 16 are typically considered indicative of clinically significant depression.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439534|NCT00938964|Secondary|Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439535|NCT00938964|Secondary|Change in Neurological Function, as Measured by the National Institutes of Health Stroke Scale (NIHSS)|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1439536|NCT00938964|Secondary|Change in Duke Activity Status Index (DASI)|The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done “with no difficulty” receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.|baseline, 1-year|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439537|NCT00938964|Secondary|Change in Duke Activity Status Index (DASI)|The DASI is a 12-item scale of functional capacity that has been found to correlate well with objective measures of maximal exercise capacity. Items reflect activities of personal care, ambulation, household tasks, sexual function, and recreational activities. Activities done “with no difficulty” receive scores, which are weighted and summed, for a quantitative measure of functional status. Scores range from 0 to 60; a higher-weighted score indicates better function.|baseline, 6-weeks||||units on a scale||Standard Deviation|Mean
1440159|NCT00933543|Primary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||12 weeks after the first treatment|ITT|||percentage of participants||95% Confidence Interval|Number
1439538|NCT00938964|Secondary|Change in Cognitive Function From Baseline|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 1 year cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement|1 year after surgery|There was 26 lidocaine patients and 17 placebo patients lost to follow-up between the primary 6-week follow-up and the final 1-year follow-up time point. Only those returning for 1 year follow-up were included in the analysis.|||units on a scale||Standard Deviation|Mean
1439539|NCT00938964|Secondary|Transcerebral Activation Gradient of Platelet-neutrophil Conjugates|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects.|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
1439540|NCT00938964|Secondary|Transcerebral Activation Gradients of Monocytes|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects.|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
1439541|NCT00938964|Secondary|Transcerebral Activation Gradients of Neutrophils|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removal and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
1439542|NCT00938964|Secondary|Transcerebral Activation Gradients of Platelets|Paired jugular venous and radial arterial blood samples were drawn at baseline, cross-clamp removal, end of cardiopulmonary bypass, and 6 hours post cross-clamp removalime points and analyzed by fluorescence-activated cell sorting to identify activated platelets. Transcerebral activation gradients were calculated by subtracting arterial values from venous values and were compared between groups|Baseline to 6 hours post cross-clamp removal|Planned substudy, that was analyzed after 202 enrolled subjects|||Mean linear fluorescence intensity-MLFI||Standard Deviation|Mean
1439543|NCT00938964|Primary|Count of Participants With a Decline of Greater Than or Equal to One Standard Deviation in One or More of Five Cognitive Domain Scores Reported as a Dichotomous Post-operative Cognitive Deficit (POCD) Outcome|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. Each domain score is normally distributed with a mean of zero. A change score was calculated for each domain by subtracting the baseline from the 6-week score. A dichotomous outcome variable of post-operative cognitive deficit was defined as a decline of ≥1 standard deviation in 1 or more of the 5 domains.|Preoperative to 6 weeks after surgery||||Participants|||Count of Participants
1439544|NCT00938964|Primary|Change in Cognitive Function From Baseline Characterized as Continuous Cognitive Change|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the 14 cognitive test scores from baseline. We chose a five-factor solution, which represents 5 cognitive domains: structured verbal memory, unstructured verbal memory, executive function, visual memory and attention/concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 5 preoperative domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.35. A negative change score indicating decline and a positive score indicating improvement.|Preoperative to 6 weeks after surgery||||units on a scale||Standard Deviation|Mean
1439545|NCT00938886|Secondary|7-day Point Prevalence Smoking Abstinence|Self-report abstinence from smoking over the past 7 days biochemically confirmed with carbon monoxide and saliva cotinine.|26 weeks after target quit smoking date||||Participants|||Count of Participants
1439546|NCT00938886|Primary|Percent Heavy Drinking Days|Defined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day|Across the 6 months following smoking quit date||||percentage of days||Standard Deviation|Mean
1439547|NCT00938860|Secondary|Number of Participants With Dose Reduction or Discontinuation of Antiviral (AV) Therapy Due to Poor Tolerability at Any Time During the Study for Any Reason|Defined as number of patients with dose reduction or discontinuation of AV therapy due to poor tolerability|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439582|NCT00938639|Secondary|Duration of Solicited Local AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
1439548|NCT00938860|Secondary|Number of Participants for Relapse Rate|Defined as reappearance of detectable Hepatitis C Virus (HCV) RNA at 24 weeks after completion of antiviral treatment when HCV RNA was undetectable at the end of treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439549|NCT00938860|Secondary|Number of Participants of True Non-responder Rate|Defined as failure to achieve at least a 2 log reduction of Hepatitis C virus (HCV) RNA. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439550|NCT00938860|Secondary|Number of Participants for the End of Treatment Response (ETR)|ETR defined as non-detectable HCV RNA at the completion of AV treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439551|NCT00938860|Secondary|Number of Participants of Early Viral Response (EVR)|EVR defined as non-detectable HCV RNA or a ≥2 logs reduction of HCV RNA at 12 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 12|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439552|NCT00938860|Secondary|Number of Participants of Rapid Viral Response (RVR)|RVR defined as non-detectable HCV RNA 4 weeks after initiation of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 4|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439553|NCT00938860|Secondary|Number of Participants With Fibrosis Progression (Increase in Ishak-Knodell (IK) Score by at Least One Point From the Baseline)|Ishak-Knodell Score: 0=No fibrosis; 01=Fibrous expansion of some portal areas, with or without short fibrous septa; 02=Fibrous expansion of most portal areas, with or without short fibrous septa; 03=Fibrous expansion of most portal areas, with occasional portal to portal (P-P) bridging; 04=Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)); 05=Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); 06=Cirrhosis, probable or definite, Participants showing an increase of Ishak Knodell fibrosis score by at least one level (increase of ≥1)|Week 80|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439554|NCT00938860|Secondary|Number of Events of the Composite Endpoint of Biopsy Proven Acute Rejections (BPAR), Death or Graft Loss and of the Individual Components|Efficacy failure (biopsy proven acute rejection (BPAR), graft loss, or death|Week 80|Intent-to-Treat (ITT) population: The ITT population consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Number of events|||Number
1439555|NCT00938860|Primary|Number of Participants Sustained Virological Response (SVR) Following Treatment of Hepatitis C Virus (HCV) Infection With Peg-IFN and Ribavirin in Liver Transplanted Recipients on Maintenance Therapy With Neoral or Tacrolimus|The achievement of SVR, defined as HCV RNA below limit of detection at the end of AV treatment, 24 weeks after end of AV treatment (W24 post). A dichotomous variable (SVR achieved: Yes/No) was computed. A patient was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at W24post, or at any time between W24 and completion of antiviral treatment. The HCV RNA detection limit was <15 IU/ml (<1.18 log IU/ml)|Week 24|The efficacy population was defined as a subset of the ITT population with sufficient compliance to the protocol procedures to allow meaningful conclusions. Patients were excluded from the Efficacy population in case of: Error in treatment assignment, if the randomized study medication was not initiated, antiviral therapy was not initiated|||Participants|||Number
1439556|NCT00938782|Primary|Time to Extubation|The exact time from end of last anesthetic drug to time of tracheal extubation.|Measured from time of end anesthesia to time of tracheal extubation.|All patients enrolled in both groups.|||minutes||Standard Deviation|Mean
1439557|NCT00938717|Secondary|12-Week Percent of Abdominal Pain-free Days|"Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst.~Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Percent of Pain-free Days||Standard Deviation|Mean
1439558|NCT00938717|Secondary|Abdominal Pain Responder for 6 Out of 12 Weeks|A patient is considered to be an AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1440160|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at baseline|Baseline||||mm||Standard Deviation|Mean
1439559|NCT00938717|Secondary|Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment|A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1439560|NCT00938717|Secondary|12-Week Change in Bloating|"Bloating was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
1439561|NCT00938717|Secondary|12-Week Change in Abdominal Discomfort|"Abdominal discomfort was assessed on an 11-point scale where a value of 0 is none and a value of 10 is very severe."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
1439562|NCT00938717|Secondary|12-Week Change in Abdominal Pain Score|Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
1439563|NCT00938717|Secondary|12-Week Change in Severity of Straining|"Straining is measured on a 5-point scale where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
1439564|NCT00938717|Secondary|12-Week Change in Stool Consistency|"The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid])."|Change from Baseline to Week 12|805 patients were randomized to treatment; 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and included in the ITT Population; 134 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||Units on a scale||Standard Error|Least Squares Mean
1439565|NCT00938717|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||SBMs per Week||Standard Error|Least Squares Mean
1439566|NCT00938717|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||CSBMs per Week||Standard Error|Least Squares Mean
1439567|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks|"A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1439568|NCT00938717|Primary|Abdominal Pain Responder, 9 Out of 12 Weeks|"A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week.~The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1439569|NCT00938717|Primary|Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks|"A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week.~A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1439570|NCT00938717|Primary|Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks|"A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week.~The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP.~SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation."|Change from Baseline to Week 12|805 patients were randomized to treatment. 804 patients had at least 1 postrandomization entry of the primary efficacy assessment and were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1439571|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Nasal) at Week 2|Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
1439572|NCT00938704|Secondary|Change From Baseline in Conjunctival Staining (Temporal) at Week 2|Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
1439573|NCT00938704|Secondary|Change From Baseline in Corneal Staining at Week 2|Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
1439574|NCT00938704|Secondary|Change From Baseline in Tear Breakup Time (TBUT) at Week 2|Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Seconds||Standard Deviation|Mean
1439575|NCT00938704|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2|Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.|Baseline, Week 2|Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).|||Scores on a Scale||Standard Deviation|Mean
1439576|NCT00938639|Secondary|Frequency and Intensity of Unsolicited AEs|"Unsolicited AEs included AEs other than those specifically sought for.~The grading definitions were:~Mild (Grade 1): Symptoms were easily tolerated and did not interfere with daily activities.~Moderate (Grade 2): Enough discomfort to cause some interference with daily activities.~Severe (Grade 3): Incapacitating, with inability to work or do usual activities."|From Day 0 to Day 20 after vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439577|NCT00938639|Secondary|Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)|An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).|Up to 180 days after the last vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439578|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the second vaccination and up to Day 20 after the second vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
1439579|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the Second Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the second vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439580|NCT00938639|Secondary|Duration of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
1439581|NCT00938639|Secondary|Frequency and Intensity of Solicited Systemic AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Temperature 102.2°F (39.0°C) or more for fevers.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1440161|NCT00933491|Primary|Radiographic Bone Level|Mean radiographic bone level at 12 months|12 months||||mm||Standard Deviation|Mean
1439584|NCT00938639|Secondary|Duration of Solicited Local AEs After the First Vaccination|Solicited AEs included AEs that were specifically sought for.|From Day 0 to Day 6 after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||days||Standard Deviation|Mean
1439585|NCT00938639|Secondary|Frequency and Intensity of Solicited Local Adverse Events (AEs) After the First Vaccination|Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Prevented normal daily activities; Size > 100 mm for injection site redness, induration/swelling, and bruising.|From Day 0 to Day 6 after the first vaccination|The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data.|||percentage of participants|||Number
1439586|NCT00938639|Secondary|Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More 180 Days After the Second Vaccination||180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439587|NCT00938639|Secondary|GMFI in the HI Antibody Titre 180 Days After the Second Vaccination|The GMFI in antibody titre was calculated by taking the anti-logs of the means of the log transformed fold-increases in the antibody titre 180 days after the second vaccination over the antibody titre 21 days after the second vaccination.|21 days and 180 days after the second vaccination|The Evaluable Population comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1439588|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Greater Than or Equal to 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre greater than or equal to 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre of 1:10 or more are presented in this outcome measure while those with a baseline titre less than 1:10 are presented in a separate outcome measure.~Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre (ie, a significant increase in antibody titre after vaccination)."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439589|NCT00938639|Secondary|Percentage of Participants With a Baseline Titre Less Than 1:10 Achieving Seroconversion After Vaccination|"The number of participants with a baseline titre less than 1:10 differed according to antibody assay (HI or MN) and is shown in the category titles accordingly. The total number of participants analysed includes all evaluable participants; however, the analysis is stratified by baseline titre and those participants with a baseline titre less than 1:10 are presented in this outcome measure while those with a baseline titre of 1:10 or more are presented in a separate outcome measure.~Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre."|Before and 21 days after each vaccination|The Evaluable Population comprised all randomised participants who received the first (or second, as appropriate) study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439590|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439591|NCT00938639|Secondary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination by Age Group|Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years.|21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439592|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the Second Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1439603|NCT00938548|Primary|Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.|1, 6, 24, 48 hour||||participants|||Number
1439593|NCT00938639|Secondary|GMFI in the HI and MN Antibody Titre After the First Vaccination by Age Group|"GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1439594|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439595|NCT00938639|Secondary|HI and MN Antibody Titre Seroconversion Rate After the First Vaccination by Age Group|"Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.~Adults were aged from 18 to 49 years; Older adults were aged from 50 to 64 years."|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439596|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the Second Vaccination||21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439597|NCT00938639|Primary|Percentage of Participants Achieving a HI or MN Antibody Titre of 1:40 or More After the First Vaccination||21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439598|NCT00938639|Primary|GMFI in the HI and MN Antibody Titer After the Second Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1439599|NCT00938639|Primary|Geometric Mean Fold Increase (GMFI) in the HI and MN Antibody Titre After the First Vaccination|GMFI in antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
1439600|NCT00938639|Primary|HI and MN Antibody Titre Seroconversion Rate After the Second Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the second vaccination|The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439601|NCT00938639|Primary|Haemagglutination Inhibition (HI) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination|Antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination antibody titre of 1:40 or more; or participants with a pre-vaccination titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.|Before and 21 days after the first vaccination|The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).|||percentage of participants||95% Confidence Interval|Number
1439602|NCT00938548|Secondary|Pain Scores (VNRS) at 1 Week and 1 Month After Operation|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1 week, 1 month||||Units on a scale||Standard Deviation|Mean
1441682|NCT00923260|Primary|Components of Metabolic Syndrome (Diastolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mmHg||Standard Deviation|Mean
1439604|NCT00938548|Primary|Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.|1, 6, 24, 48 hour||||Units on a scale||Full Range|Median
1439605|NCT00938470|Secondary|Percentage of Participants With Overall Clinical Tumor Response (CR or PR)|Overall clinical tumor response rate was defined as the percentage of evaluable participants who achieved either complete response (CR) or partial response (PR) noted on the objective status from pre-surgical staging (for arm II) or either from pre-RT or pre-surgical staging (for arm I). > CR was defined as disappearance of all non-target lesion (TL) and normalization of tumor biomarker level, all lymph nodes (LN) must be non-pathological in size (<1 cm short axis); or disappearance of all TL and normalization of tumor biomarkers, any pathological LN (whether target or non-target) must have reduction in short axis to <1 cm; or >=30% decrease in the sum of the diameters of TL taking as reference the baseline sum of the diameters.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1439606|NCT00938470|Secondary|Number of Participants Who Experienced a Maximum Grade of 3 or Above Adverse Event|Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||Participants|||Count of Participants
1439607|NCT00938470|Secondary|Disease-free Survival|Disease-free survival was defined as the time from randomization to the date of recurrent or death, whichever comes first.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||months||95% Confidence Interval|Median
1439608|NCT00938470|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the time of death from any cause. Overall survival was censored at the date of last follow-up visit for patients who are still alive or loss of follow-up.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||months||95% Confidence Interval|Median
1439609|NCT00938470|Primary|Percentage of Participants With Pathologic Complete Response (PCR)|Pathologic complete response was defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.|Up to 2 years|Eligible randomized participants who initiated first cycle of protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1439610|NCT00938457|Secondary|Evaluation of Cause of Death (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.||||||
1439611|NCT00938457|Secondary|Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.||||||
1439612|NCT00938457|Secondary|Refinement of Toxicity and Adverse Events Profile (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.||||||
1439613|NCT00938457|Secondary|Median Time to Progression of Treated Tumors (Phase II)||Up to 5 years|No patients were accrued to the Phase II portion.||||||
1439614|NCT00938457|Secondary|Local Control (LC) Cumulative Incidence Rates (Phase II)||3 and 6 months and 1, 2, and 5 years|No patients were accrued to the Phase II portion.||||||
1439615|NCT00938457|Secondary|Radiographic Response Rate (Phase II)||Up to 2 years|No patients were accrued to the Phase II portion.||||||
1439616|NCT00938457|Secondary|Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)||Up to 2 years|||||||
1439617|NCT00938457|Secondary|Toxicity and Adverse Events Profile (Phase I)|"Number of patients with a grade >= 3 adverse event.~Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.~Description of Grades:~Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death"|Up to 2 years||||participants|||Number
1439618|NCT00938457|Primary|Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)|LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.|At 1 year|No patients were accrued to the Phase II portion.||||||
1439619|NCT00938457|Primary|Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.||2 months|Not enough patients were accrued to the Phase I portion to determine the MTD.||||||
1439620|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 42|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439637|NCT00938392|Secondary|Number of Subjects Seroprotected for the 3 Vaccine Strains|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.|||Participants|||Count of Participants
1439621|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 35|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439622|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 28|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439623|NCT00938431|Secondary|Plasma Ctrough Values for SPM 12809 at Day 7|"SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439624|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 42|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 42|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439625|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 35|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 35|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439636|NCT00938392|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever [oral temperature greater than or equal to 38 degrees Celsius (°C)]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed.|||Participants|||Count of Participants
1439626|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 28|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 28|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439627|NCT00938431|Secondary|Plasma Ctrough Values for Lacosamide at Day 7|"During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.~The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|Day 7|"The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847.~The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1439628|NCT00938431|Secondary|Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.~The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No Change~Minimally worse~Much worse~Very much worse"|Visit 5 (Day 27/28) or Early Termination|"This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.~For one subject in the age group >=12 years to <=17 years no data is available."|||Participants|||Number
1439629|NCT00938431|Secondary|Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination|"For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status.~The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Visit 5 (Day 27/28) or Early Termination|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.|||Participants|||Number
1439630|NCT00938431|Secondary|Change in Seizure Frequency From Baseline to End of Treatment||From Baseline to End of Treatment (approximately 13 weeks)|This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.|||percentage change||Standard Deviation|Mean
1439631|NCT00938431|Primary|Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)||13 weeks|The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.|||participants|||Number
1439632|NCT00938392|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (up to Day 21)|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.|||Participants|||Count of Participants
1439633|NCT00938392|Secondary|Number of Subjects Reporting Adverse Events of Specific Interest (AESI)|AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.|||Participants|||Count of Participants
1439634|NCT00938392|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 21-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.|||Participants|||Count of Participants
1439635|NCT00938392|Secondary|Duration of Solicited Local and General Symptoms|Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.|During the 7-day post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only.|||Days||Full Range|Median
1439824|NCT00937235|Primary|Number of Participants With 7-day Point Prevalence Smoking Abstinence|Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of <15ng/ml, and CO < 10 ppm.|At 3-month follow-up (6-month post-quit day)||||Participants|||Count of Participants
1439638|NCT00938392|Secondary|Seroconversion Factor for the 3 Vaccine Strains|Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.|||Fold Increase||95% Confidence Interval|Geometric Mean
1439639|NCT00938392|Secondary|Number of Subjects Seroconverted for the 3 Vaccine Strains|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Day 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.|||Participants|||Count of Participants
1439640|NCT00938392|Secondary|Number of Subjects Seropositive Against the 3 Vaccine Strains|A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.|||Participants|||Count of Participants
1439641|NCT00938392|Primary|Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains|Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.|At Days 0 and 21|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.|||Titer||95% Confidence Interval|Geometric Mean
1439642|NCT00938366|Secondary|Percentage of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1 year, that were absent before treatment or that worsened relative to pre treatment state. AEs Leading to Death and AEs Leading to Discontinuation were also presented in the outcome measure.|Up to 1 year|Safety analysis set included all the randomized subjects who received treatment with at least one dose of either cladribine or pantoprazole during the study period.|||percentage of subjects|||Number
1439643|NCT00938366|Other Pre-specified|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/f) of Cladribine|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||liter||Geometric Coefficient of Variation|Geometric Mean
1439644|NCT00938366|Secondary|Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of Cladribine|Clearance of a drug was a measure of the rate at which cladribine is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
1439645|NCT00938366|Secondary|Apparent Terminal Half-life (t1/2) of Cladribine|The apparent terminal half-life was defined as the time required for the plasma concentration of drug cladribine to decrease 50 percent (%) in the final stage of its elimination.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour||Geometric Coefficient of Variation|Geometric Mean
1439646|NCT00938366|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Cladribine|The tmax was defined as time taken by the drug cladribine to reach Cmax.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour||Full Range|Median
1439647|NCT00938366|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Cladribine|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1439648|NCT00938366|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Cladribine|The AUC (0-t) was defined as the area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|The PK analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1439825|NCT00937157|Secondary|To Determine the Correlation of MTI and Cumulative Gd Enhancing Lesions Using the 1.5T and 3T Protocols.||day 0, 3, 6, 9 & 12 months|||||||
1439649|NCT00938366|Primary|Maximum Plasma Concentration (Cmax) of Cladribine|The maximum or peak plasma concentration observed after the administration of cladribine.|Pre-dose (within 30 minutes prior to dosing) and at 0.5,1, 3, 6, 8, 12,16, 24, 36, 48 Hour post-dose|Pharmacokinetic (PK) analysis set included all the subjects who received cladribine alone and cladribine + pantoprazole according to the randomization and completed the full PK sampling.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
1439650|NCT00938327|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (from Day 0 up to Day 30)|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1439651|NCT00938327|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Day 0 – Day 30) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1439652|NCT00938327|Secondary|Number of Subjects Reporting Solicited General Symptoms|Cough: Cough/runny nose of any intensity Diarrhoea: Passage of three or more looser than normal stools within a day Irritability: Cried more than usual Loss of appetite: Ate less than usual Temperature: Axillary temperature greater than or equal to 37.5°C Vomiting: One or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day|During the 8-day (Day 0 – Day 7) follow-up period after each vaccination|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1439653|NCT00938327|Primary|Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhoea)|"Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C.~Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhoea was defined as at least 6 looser than normal stools per day."|During the 8-day (Day 0 – Day 7) follow-up period after each vaccination.|Analysis was performed on the Total Vaccinated Cohort.|||subjects|||Number
1439654|NCT00938314|Secondary|Geriatric Depression Scale at Day 90|The Geriatric Depression Scale is commonly used to assess depression in stroke patients of any age by asking 15 yes/no questions, and then scored. A score of 0 – 5 is normal, whereas a score of 6 -15 suggests depression.|Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||scores on a scale||Standard Deviation|Mean
1439655|NCT00938314|Secondary|Trails B Test Change From Baseline at Day 90|The Trails B test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 alpha numeric circles (e.g., 1, A, 2, B, 3, C, 4, D)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||seconds||Standard Deviation|Mean
1439656|NCT00938314|Secondary|Trails A Test Change From Baseline at Day 90|The Trails A test measures visual scanning, numeric sequencing, and visual-motor coordination; the test score is the time (seconds) required to connect 25 numbers (e.g., 1, 2, 3, 4…)|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||seconds||Standard Deviation|Mean
1439657|NCT00938314|Secondary|Line Cancellation Test Change From Baseline at Day 90|The Line Cancellation Test detects the loss of awareness of one side of the body. A score of 0.00 (no units) is normal (patient favors neither right nor left side). A score of +1.00 indicates severe unawareness of the left side. A score of -1.00 indicates severe unawareness of the right side.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||scores on a scale||Standard Deviation|Mean
1439658|NCT00938314|Secondary|Boston Naming Test (BNT) Change From Baseline at Day 90|The BNT assesses impairment of language ability by asking patients to identify 20 different pictures each time the test is taken. A score of 20 is best, 0 is worst.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||Scores on a scale||Standard Deviation|Mean
1439659|NCT00938314|Secondary|Gait Velocity Test Change From Baseline at Day 90|The Gait Velocity Test assesses ability to walk as measured by the time (seconds) it takes a patient to walk 10 meters.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||seconds||Standard Deviation|Mean
1439660|NCT00938314|Secondary|Action Research Arm Test (ARAT) Change From Baseline at Day 90|The ARAT assesses recovery of arm function following stroke through a series of subtests judging ability to grasp, grip, pinch, or move the arm; scores are on a scale; The total maximum (best) score is 57 and the total minimum (worst) score is 0.|Baseline and Day 90|"Not all patients enrolled in the group completed this outcome measure.~The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug."|||scores on a scale||Standard Deviation|Mean
1439661|NCT00938314|Secondary|Barthel Index at Day 90|The Barthel Index measures 10 activities of daily living and mobility. A score of 100 = is best (able to live at home with a degree of independence), 0 is worst.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||Scores on a scale||Standard Deviation|Mean
1439826|NCT00937157|Primary|A Decrease in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.||0-180 days and 0-360 days|Of the 12 RRMS patients enrolled, only the 8 who completed days 180 and 360 were analyzed. There was no imputation used.|||Cumulative GAD lesions (number of)||Standard Deviation|Mean
1439662|NCT00938314|Secondary|Modified Rankin Scale (mRS) Response <=2 at Day 90|The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0 (perfect health without symptoms) to 6 (dead). mRS response <=2 is defined as the mRS score <=2 at Day 90.|Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||participants|||Number
1439663|NCT00938314|Secondary|NIHSS Change From Baseline at Day 30|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 30|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
1439664|NCT00938314|Secondary|NIHSS Response >=4 at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead). NIHSS Response >=4 is defined as a >=4 change from baseline at Day 90.|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||participants|||Number
1439665|NCT00938314|Primary|National Institutes of Health Stroke Scale (NIHSS) Change From Baseline at Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42 (dead).|Baseline and Day 90|The analysis was conducted using a modified Intent-to-Treat population, defined as all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
1439666|NCT00938041|Primary|Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as those events that were fatal or immediately life-threatening, and those events that resulted in hospitalization; prolonged an existing hospitalization; or resulted in disability, congenital anomaly, or cancer. Refer to the general AE/SAE module for a complete list of all AEs and SAEs.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population|||Participants|||Number
1439667|NCT00938041|Primary|Overall Survival|Time to death (overall survival) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the date of death from any cause.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not die were censored at the date of their last contact in the study.|||Months||95% Confidence Interval|Median
1439668|NCT00938041|Primary|Time to Treatment Failure|Time to treatment failure is defined as the time from the dosimetric dose to the first occurrence of treatment withdrawal, a decision to receive additional therapy, study withdrawal, disease progression, or death.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who withdrew from the study for reasons other than progression or death were censored at the date of study withdrawal. Participants who did not meet any of the criteria for treatment failure were censored at their date of last contact in the study.|||Months||95% Confidence Interval|Median
1439669|NCT00938041|Primary|Progression-free Survival|Progression-free survival (time to progression or death) is defined as the time from the start of retreatment (i.e., the dosimetric dose) to the first documented progression or death. Disease Progression (PD) is defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be grater than 2 cm diameter by radiographic evaluation or grater than 1 cm diameter by physical examination.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Participants who did not progress or die were censored at their date of last contact in the study.|||Months||95% Confidence Interval|Median
1439670|NCT00938041|Primary|Duration of Response for All Confirmed Responders (CR + CCR + PR)|For participants with CR, clinical CR (CCR), or partial response (PR), duration of response is defined as the time from the first documented response to the first documented progression. CCR is defined as the complete resolution of all disease-related symptoms, but residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion <=2 centimeters (cm) in diameter by radiographic evaluation or <=1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations and, if unchanged or if further decreases for 6 months or longer are present, the participant will then be reclassified as a CR (complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease). PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population. Only those participants with a confirmed CR, CCR, or PR were analyzed.|||Months||95% Confidence Interval|Median
1439671|NCT00938041|Primary|Number of Participants With Complete Response and Confirmed Complete Response|Complete response (CR) is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. Response is defined as the best response achieved at any evaluation. A confirmed response is defined as a response that was confirmed by two separate response evaluations occurring at least 4 weeks apart.|Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months)|ITT-Exposed Population: all participants who received at least one dose of study drug|||Participants|||Number
1439694|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 12|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439672|NCT00938015|Secondary|Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)|HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1439673|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1439674|NCT00938015|Secondary|Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation|Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
1439675|NCT00938015|Secondary|Number of Joints With Active Arthritis|Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.|Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78|Efficacy set included all the participants who signed ICF. ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Joints||Standard Deviation|Mean
1439676|NCT00938015|Secondary|Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment||Baseline up to Month 78|Efficacy set included all the participants who signed ICF.|||Percentage of participants|||Number
1439677|NCT00938015|Secondary|Incidence of Adverse Events and Serious Adverse Events Per Participant-Year|Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.|Baseline up to Month 6, 12, 18, 30, 42, 54, 66|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Events per participant year|||Number
1439678|NCT00938015|Secondary|Percentage of Participants With at Least 1 Adverse Event (AE) Per Year|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Percentage of participants|||Number
1439679|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 5 up to Year 6|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1439680|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 4 up to Year 5|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1439681|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 3 up to Year 4|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1439827|NCT00937118|Primary|Duodenal-related Complications|Duodenal-related complications including leak, obstruction, and abscess|20 years|Patients with duodenal related complications|||percentage of subjects|||Number
1452610|NCT00833690|Secondary|Serum Urate|From blood sample drawn a month after stopping study drug|Safety Visit (SV); 30 +/- 3 days following ESD or Month 24 Visit||||mg/dL||Standard Deviation|Mean
1439682|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 2 up to Year 3|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1439683|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Year 1 up to Year 2|Safety set included all the participants who signed ICF and had at least one dose of study medication and had follow-up data. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Percentage of participants|||Number
1439684|NCT00938015|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Year 1|Safety set included all the participants who signed informed consent form (ICF) and had at least one dose of study medication and had follow-up data.|||Percentage of participants|||Number
1439685|NCT00937950|Primary|Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439686|NCT00937950|Primary|Number of Subjects With AEs or SAEs Leading to Withdrawal|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Up to Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439687|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439688|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439689|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 24|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjetcs|||Number
1439690|NCT00937950|Primary|Number of Subjects With Treatment Referrals by Treatment Type|Subjects who presented treatment referral, Loop excision of cervix, Loop cone of cervix, Cold knife cone of cervix, Laser excision, other.|At Month 12|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439691|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439692|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 36|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439693|NCT00937950|Primary|Number of Subjects With Cervical Biopsy Results|Subjects with negative and positive cervical biopsy results for only CIN1, only CIN2, only CIN3, CIN1 and CIN2, CIN1 and CIN3, CIN2 and CIN3, CIN1 and CIN2 and CIN3, AIS, Invasive malignancy, other.|At Month 24|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439828|NCT00937105|Secondary|Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins|Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids|up to 1 year|All participants in which valid lids bioburden data was available|||participants|||Number
1439695|NCT00937950|Primary|Number of Subjects With Cervical Cytology|Subjects who presented normal, ASC-US (Atypical Squamous Cell of Undetermined Significance), LSIL (Low-grade Squamous Intraepithelial Lesions), HSIL (High-grade Squamous Intraepithelial Lesions), AGC (Atypical Glandular Cells), ASC-H (Atypical Squamous Cells cannot exclude HSIL) cervical cytology.|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439696|NCT00937950|Primary|Number of Subjects With Colposcopy Referral and Colposcopy Adequacy|Subjects with colposcopy referral and colposcopy adequacy.|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439697|NCT00937950|Primary|Number of Subjects With HPV DNA in Cervical Samples by HCII|Subjects that presented oncogenic HPV DNA in cervical samples by HPV DNA testing (Hybrid Capture® 2 test [HCII]).|At Months 12, 24, 36, 48|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and results available at each analysis timepoint.|||Subjects|||Number
1439698|NCT00937937|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1439699|NCT00937937|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Disease assessments for response were performed every 6 weeks, up to 3 years||||percentage of participants||95% Confidence Interval|Mean
1439700|NCT00937937|Secondary|Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.|Disease assessment was performed every 6 weeks, up to 3 years.||||months||95% Confidence Interval|Median
1439701|NCT00937937|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Weekly, up to 3 years||||months||95% Confidence Interval|Median
1439702|NCT00937833|Primary|Number of Continent Patients Post Prostatectomy||1 Month||||participants|||Number
1439703|NCT00937794|Primary|Number of Participants With a Score of at Least 90 on The General Conceptual Ability (GCA) Sub-Scale of The Differential Ability Scale (DAS)|The GCA sub-scale of the DAS, Second Edition (DAS-II) was used to obtain a general measure of cognitive ability.The maximum score is 120, with a higher score indicating greater cognitive ability. A score of 100 is considered an average score.|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.|||participants|||Number
1439704|NCT00937794|Primary|Number of Participants Who Were Screened For The Follow-On Study With an Investigational Agent|"Standardized tests were used to identify patients who were receiving treatment with Elaprase, had cognitive impairment, and were suitable to participate in the follow-on clinical study (HGT-HIT-045). Assessments included:~Cognition: The Differential Ability Scale, Second Edition (DAS-II) or the Bayley Scales of Infant Development, Third Edition (BSID-III);~Adaptive Behavior: The Scale of Independent Behavior-Revised (SIB-R);~Executive Function: The Behavior Rating Inventory of Executive Function-Preschool version (BRIEF-P) for children or the Behavior Rating Inventory of Executive Function (BRIEF) for children less than or ≥6 years of age, respectively;~Motor: The Peabody Developmental Motor Scales-2 (PDMS-2) or the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for children less than or ≥6 years of age, respectively."|1 month|All enrolled patients, defined as patients who met the inclusion criteria and consented to participate in the study.|||participants|||Number
1439705|NCT00937768|Secondary|Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)|||||||||
1439706|NCT00937768|Secondary|Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate|||||||||
1439707|NCT00937768|Secondary|Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms|||||||||
1439708|NCT00937768|Secondary|Quality of Life as Assessed by the FACT-P and LASA Tool Within and Between the Two Treatment Arms||Baseline and months 3, 6, 9, 12, 15, 18, 21, and 24|||||||
1439709|NCT00937768|Secondary|Toxicity as Per NCI CTCAE Version 3|||||||||
1439710|NCT00937768|Secondary|Biochemical Progression-free Survival (BPFS), Overall Survival (OS), and Prostate Cancer Specific Survival (PCS)|||||||||
1439711|NCT00937768|Primary|Biochemical Progression-free Survival Rate||2 years|No participants reached the 2 years follow up due to the early termination of the trial.||||||
1439727|NCT00937521|Secondary|Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.|||Subjects|||Number
1441683|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||mmHg||Standard Deviation|Mean
1439712|NCT00937560|Secondary|Biological Progression-free Interval|Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for patients with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment and initial normalisation of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per patient on 2 occasions at least 1 week apart (for patients with elevated CA-125 pre-treatment which never normalised).|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Months||95% Confidence Interval|Median
1439713|NCT00937560|Secondary|Overall Survival at 1 Year and 2 Years|Reported are the percentage of participants that were alive at 1 year and 2 years after enrolling in the study.|Baseline to Year 2|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Percentage of participants||95% Confidence Interval|Number
1439714|NCT00937560|Secondary|Duration of Response|Duration of response was defined as the interval between the date of the first documented response by RECIST to the date of first disease progression or death, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Months||95% Confidence Interval|Median
1439715|NCT00937560|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), a CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions and a PR was defined as the disappearance of all target lesions and persistence of ≥ 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. Only participants with measurable disease were included in the analysis according to RECIST only. Only participants with a Baseline ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal who had a ≥ 50% reduction of CA-125 from Baseline were included in the analysis according to CA-125 level.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Percentage of participants||95% Confidence Interval|Number
1439716|NCT00937560|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first administration of any study treatment to the first disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the data cut-off date of 19 Jul 2012 for analysis of the primary Outcome Measure (follow-up time up to 3 years, 1 month)|Intent-to-treat population: All enrolled participants who received at least 1 dose of any study medication (bevacizumab, carboplatin, or paclitaxel).|||Months||90% Confidence Interval|Median
1439717|NCT00937547|Primary|HPV Type 51|Number of biopsies positive to HPV 51.|6 months||||biopsies|||Number
1439718|NCT00937547|Primary|HPV Type 58|Number of biopsies positive to HPV 58.|6 months||||biopsies|||Number
1439719|NCT00937547|Primary|HPV Type 45|Number of biopsies positive to HPV 45.|6 months||||biopsies|||Number
1439720|NCT00937547|Primary|HPV Type 33|Number of biopsies positive to HPV 33.|6 months||||biopsies|||Number
1439721|NCT00937547|Primary|HPV Type 31|Number of biopsies positive to HPV 31.|6 months||||biopsies|||Number
1439722|NCT00937547|Primary|HPV Type 18|Number of biopsies positive to HPV 18.|6 months||||biopsies|||Number
1439723|NCT00937547|Primary|HPV Type 16|Number of biopsies positive to HPV 16.|6 months||||biopsies|||Number
1439724|NCT00937547|Primary|HPV Identification|HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer|6 months||||biopsies|||Number
1439725|NCT00937521|Secondary|Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group|To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.|Day 1 through day 7 at 13 months age.|The analysis was performed on the safety population.|||Subjects|||Number
1439726|NCT00937521|Secondary|Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.|Overall study period.|The analysis was performed on the safety population.|||Subjects|||Number
1439741|NCT00937495|Secondary|Progression Free Survival|Progression-free survival is defined as the time from registration to the time of progression or death, whichever comes first. The distribution and median of progression-free survival times will be estimated using the method of Kaplan-Meier.|Up to 2 years||||months||95% Confidence Interval|Median
1439728|NCT00937521|Secondary|Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.|||Subjects|||Number
1439729|NCT00937521|Primary|Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination|To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.|Day 1 to day 3 after first vaccination.|The analysis was done on the Safety Population.|||Subjects|||Number
1439730|NCT00937521|Secondary|Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination|To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.|Day 1 through day 7 after each vaccination.|The analysis was performed on the safety population.|||Subjects|||Number
1439731|NCT00937521|Secondary|Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination|To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).|Day 1 through day 7 after second and third vaccination.|As per safety dataset.|||Subjects|||Number
1439732|NCT00937521|Secondary|Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)|To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).|1 month after booster|The analysis was done on the Per Protocol population.|||Percentage of Subjects||95% Confidence Interval|Number
1439733|NCT00937521|Secondary|Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)|To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.|At 13 months|The analysis was done on the Per Protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1439734|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)|To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.|1 month after fourth vaccination|The analysis was done on the Per Protocol Booster population.|||Percentages of Subjects||95% Confidence Interval|Number
1439735|NCT00937521|Secondary|Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)|To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.|12 months (pre-fourth vaccination)|The analysis was done on the Per Protocol Booster population.|||Percentages of Subjects||95% Confidence Interval|Number
1439736|NCT00937521|Secondary|Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).|After the third and the booster vaccination.|As per PP population.|||Ratios||95% Confidence Interval|Geometric Mean
1439737|NCT00937521|Secondary|Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)|To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.|At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days|As per PP population.|||Titers||95% Confidence Interval|Geometric Mean
1439738|NCT00937521|Secondary|Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)|"ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:~One month after third vaccination.~One month after booster vaccination (Men B at 12 months of age)."|At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)|Per Protocol Primary and Booster populations.|||Titers||95% Confidence Interval|Geometric Mean
1439739|NCT00937521|Primary|Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination|To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.|At baseline (pre-vaccination) and 30 days after the third vaccination.|Analysis as per PP population.|||Percentages of Subjects||95% Confidence Interval|Number
1439740|NCT00937495|Secondary|Overall Survival|The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
1440382|NCT00932126|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
1439742|NCT00937495|Primary|Confirmed Tumor Responses|"The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years||||participants|||Number
1439743|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented in Stage 2 for the optimal efficacious dose determined in Stage 1|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439744|NCT00937391|Secondary|Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1|The actual change in management from unenhanced to combined images recommended by the open-label Clinical Investigators is presented for both doses in Stage 1|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439745|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2|For Stage 2, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for the optimal efficacious dose determined in Stage 1.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439746|NCT00937391|Secondary|Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1|For Stage 1, the number of participants for whom the recommended management of the open-label Clinical Investigators changed from unenhanced to combined images is presented for both doses.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439747|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 2|For Stage 2 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)|||Participants|||Number
1439748|NCT00937391|Secondary|Management Based on Unenhanced Images - Stage 1|For Stage 1 based on unenhanced images, the recommended management is presented as determined by the open-label Clinical Investigators.|Within 5 minutes before injection|Full analysis set (only participants for whom information on management was given)|||Participants|||Number
1439749|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 2|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439750|NCT00937391|Secondary|Number of Participants With Diagnostic Confidence - Stage 1|The overall diagnostic confidence of the Blinded Readers and the open-label Clinical Investigators was indicated on a 3-point scale: 1=not confident; 2=confident; and 3=very confident. BR=Blinder Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439751|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 2. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439752|NCT00937391|Secondary|Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1|Those participants for whom the diagnosis changed for at least 1 Blinded Reader from unenhanced to combined images are presented for Stage 1. For completeness, the corresponding data for these participants are presented for the open-label Clinical Investigators. BR=Blinded Reader; CI=Clinical Investigator.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439753|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439754|NCT00937391|Secondary|Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1|The Blinded Readers and the open-label Clinical Investigators determined the number of participants with a change in diagnosis from unenhanced to combined images. BR = blinded reader; CI = clinical investigator|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439755|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439756|NCT00937391|Secondary|Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the most frequent diagnostic findings with the unenhanced images|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439757|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439758|NCT00937391|Secondary|Number of Participants With Quality of Border Delineation - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of border delineation based on a 3-point scale (1=excellent - border completely delineated; 2=fair but adequate - some of the border is delineated; and 3=poor - entire or almost the entire border is not delineated) by image set|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439759|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 2|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439760|NCT00937391|Secondary|Number of Participants With Quality of Lesion Visualization - Stage 1|BR = blinded reader; CI = clinical investigator. The Blinded Readers and the open-label Clinical Investigators determined the quality of lesion visualization with the unenhanced and the combined image sets based on a 3-point scale (1=excellent - lesion clearly seen and diagnosis possible; 2=fair but adequate - most of lesion seen and diagnosis possible; and 3=poor - lesion barely seen and diagnosis not possible)|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439761|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 2|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439762|NCT00937391|Secondary|Number of Participants With Number of Lesions Detected - Stage 1|BR = blinded reader; CI = clinical investigator; unenh. image = unenhanced image; comb. image= combined unenhanced and enhanced image. The Blinded Readers and the open-label Clinical Investigators determined the number of participants with 0, 1, 2, and 3 or more lesions.|Within 5 minutes after injection|Full analysis set|||Participants|||Number
1439763|NCT00937391|Primary|PK Analysis - t 1/2|t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity|Samples taken at 20 to 45 min and at 4 to 8 hours post injection; t 1/2 calculated from area under the drug concentration-time curve from administration to infinity|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||hour||Full Range|Median
1439764|NCT00937391|Primary|PK Analysis - Area Under the Drug Concentration-time Curve (AUC)|AUC = Area under the drug concentration-time curve from administration to infinity|Samples taken 20 to 45 min and 4 to 8 hours post injection. AUC calculated from time of injection to infinity.|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||µmol•hour/Liter||Full Range|Median
1439765|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW)|Vss/BW = volume of distribution at steady state normalized by body weight|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters/kg||Full Range|Median
1439766|NCT00937391|Primary|PK Analysis - Volume of Distribution at Steady State (Vss)|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters||Full Range|Median
1439767|NCT00937391|Primary|PK Analysis - Total Clearance (CL)/Body Weight (BW)|CL/BW = total clearance normalized by BW|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters/hour/kg||Full Range|Median
1439768|NCT00937391|Primary|PK Analysis - Total Clearance (CL)|Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.|20 to 45 min and 4 to 8 hours post injection|PK population (N=44) was based on the Per Protocol Set (PPS) defined for Stage 1 as all participants (n=18) who received the appropriate dose of Magnevist Injection based on kg body weight (BW) and in Stage 2 as those participants (n=26) who received +/- 10% of the appropriate dose based on kg BW and had values for both PK samples|||Liters/hour||Full Range|Median
1439769|NCT00937391|Primary|Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers|For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.|Within 5 minutes after injection|Primary Analysis Set (the first 5 PPS participants in each age group)|||Participants|||Number
1439770|NCT00937391|Primary|Dose Determined by Blinded Readers to be Superior for Diagnosis|Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters|Within 5 minutes after injection|Primary analysis set (the first 5 PPS participants in each age group)|||Participants|||Number
1439771|NCT00937391|Primary|Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set)|"A clinical judgment by the open-label Clinical Investigators (CIs) as to whether (yes) or not (no) the CI could make a diagnosis from the image."|Within 5 minutes after injection|The first 3 participants of Stage 1 received 2 IV injections of 0.05 mmol/kg body weight (BW), images were obtained after each injection and an assessment made by the CIs as to diagnostic adequacy.|||Participants|||Number
1439772|NCT00937326|Secondary|Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28|HOMA-percentage cell beta function was derived from FPG and FPI as: 20*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as assessment done on Day 1. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of beta cell function||Standard Deviation|Mean
1439773|NCT00937326|Secondary|Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28|HOMA-percentage cell beta function was derived from FPG and FPI as: 20*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28.|Day 1 and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of beta cell function||Standard Deviation|Mean
1439774|NCT00937326|Secondary|Change From Baseline in HOMA-IR at Day 28|HOMA-IR was derived from FPG and FPI as: FPI (mU/mL)*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mU*mmol per liter^2||Standard Deviation|Mean
1439775|NCT00937326|Secondary|Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28|HOMA-IR was derived from FPG and FPI as: FPI (micro units [mU]/mL)*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28.|Day 1 and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mU*mmol per liter^2||Standard Deviation|Mean
1439776|NCT00937326|Secondary|Change From Baseline in Fructosamine Levels at Day 28|Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population.|||mmol per liter||Standard Deviation|Mean
1439777|NCT00937326|Secondary|Mean Fructosamine Levels at Day 1 and Day 28|Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28.|Day 1 and Day 28|ITT Population.|||mmol/L||Standard Deviation|Mean
1439778|NCT00937326|Secondary|AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28|The assessment of PPG and PPI was performed at 30 minutes, 60 minnutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. AUC with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times) for PPG and PPI.|Day 1 (30 minutes, 60 minutes and 2 hour) and Day 28 (30 minutes, 60 minutes and 2 hour)|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol*hour per liter||Standard Deviation|Mean
1439779|NCT00937326|Secondary|Change From Baseline in HbA1c Levels at Day 28|HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected on Day 1 and Day 28. Baseline value was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
1439780|NCT00937326|Secondary|Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28|The sample for HbA1c assessment was collected on Day 28. HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months.|Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
1439781|NCT00937326|Secondary|Change From Baseline in PPG and PPI Levels at Day 28|The assessment of PPG and PPI was performed at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. Baseline for PPG was defined as the assessment value of FPG done on Day 1 and Baseline for PPI was defined as the assessment value of FPI done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (30 min, 60 min and 2 h at Day 28) values.|Baseline (Day 1) and Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
1439782|NCT00937326|Secondary|Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28|The assessment of PPG and PPI was performed on Day 28 at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast).|Day 28|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
1439783|NCT00937326|Secondary|Change From Baseline in FPI Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
1439784|NCT00937326|Secondary|Mean Fasting Plasma Insulin (FPI) Levels Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.|Up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
1440383|NCT00932126|Secondary|Area Under the Concentration-Time Curve From Time 0 to 12 Hours Post Morning Dose [AUC(0-12)]||pre-dose and 12 hours post morning dose|Data not analyzed due to early termination of the study.||||||
1439785|NCT00937326|Secondary|Change From Baseline in FPG Levels Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
1439786|NCT00937326|Secondary|Mean Fasting Plasma Glucose (FPG) Levels Over Time|The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.|Up to Day 35|ITT Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
1439787|NCT00937326|Primary|Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||mL/kg||Standard Deviation|Mean
1439788|NCT00937326|Primary|Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||Liter/hour||Standard Deviation|Mean
1439789|NCT00937326|Primary|Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight. The t1/2 was obtained as the ratio of ln2/λz, where λz is the terminal phase rate constant estimated by linear regression analysis of the concentration-time data.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
1439790|NCT00937326|Primary|Time to Cmax (Tmax) at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
1439791|NCT00937326|Primary|Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28|Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. On Day 1, Day 2 and Day 29, participants fasted for at least 10 hour overnight. The post-dose sample was collected within 2 minutes of the scheduled time. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Standard Deviation|Mean
1439801|NCT00937326|Primary|Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time|Assessment for aPTT and PT were performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.|Baseline (Day 1), Day 28 and Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Seconds||Standard Deviation|Mean
1440271|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|24 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab|||percentage of participants|||Number
1439792|NCT00937326|Primary|Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28|The pre-dose blood samples were collected within one hour prior to study medication administration. The post-dose blood samples were collected within 2 minutes of the scheduled time. AUC values reported in the analysis of AUC 0-infinity of Day 28 versus Day 1 included AUC 0-infinity on Day 1 and AUC 0-τ on Day 28. Participants fasted for at least 10 hour overnight on Day 1, 2 and 29. The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC0-infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log10 transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.|Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28)|Pharmacokinetic (PK) Population defined as all participants who received SRT2104, had sufficient blood samples taken to obtain a plasma concentration time profile and who did not violate the protocol in such a way that it could influence the statistical analysis. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)*hour/milliliter (mL)||Standard Deviation|Mean
1439793|NCT00937326|Primary|Change From Baseline in Urinalysis Parameter of pH Over Time|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessment was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Points on scale||Standard Deviation|Mean
1439794|NCT00937326|Primary|Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1439795|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time|Assessment for albumin and total protein were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Gram per liter||Standard Deviation|Mean
1439796|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Lipid Profile Over Time|Assessment for lipid profile was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. The parameters included high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and triglycerides. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||mmol per liter||Standard Deviation|Mean
1439797|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time|Assessment for direct bilirubin, indirect bilirubin, serum creatinine, total bilirubin and uric acid were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Micromole per liter||Standard Deviation|Mean
1439798|NCT00937326|Primary|Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time|Assessment for bicarbonate, BUN, calcium, chloride, magnesium, phosphate, potassium and sodium were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Micromole (mmol) per liter||Standard Deviation|Mean
1439799|NCT00937326|Primary|Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time|Assessment for ALT, AST, ALP, creatinine phosphokinase and LDH were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||International units per liter||Standard Deviation|Mean
1439800|NCT00937326|Primary|Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time|Assessment for international normalized ratio was performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.|Baseline (Day 1), Day 28 and Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1439802|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time|Assessment for mean corpuscular volume was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
1439803|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time|Assessment for mean corpuscular hemoglobin concentration was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Gram hemoglobin per liter||Standard Deviation|Mean
1439804|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time|Assessment for mean corpuscular hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Picogram per cell||Standard Deviation|Mean
1439805|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Hemoglobin Over Time|Assessment for hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Gram per liter||Standard Deviation|Mean
1439806|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Hematocrit Over Time|Assessment for hematocrit was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
1439807|NCT00937326|Primary|Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time|Assessment for RBC count was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
1439808|NCT00937326|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time|Assessment for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and white blood cell (WBC) count were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Giga cells per liter||Standard Deviation|Mean
1439809|NCT00937326|Primary|Change From Baseline in Electrocardiogram (ECG) Values Over Time|12-lead ECG was obtained in the rested state. Participants lied in supine position with ECG leads on for at least 5 minutes prior to ECG recording. The ECG was performed at Day 1 (pre-dose and post-dose), Day 8, Day 15, Day 22, Day 28 (pre-dose and pre-dose) and Day 35, and included the assessment of PR interval, QRS interval, QT interval and QTc interval. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1 [post-dose], Day 8, Day 15, Day 22, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Millisecond||Standard Deviation|Mean
1439810|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Temperature Over Time|Vital sign assessment of temperature was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Degree celcius||Standard Deviation|Mean
1439821|NCT00937235|Secondary|Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up|"Posttraumatic Symptom Scale Interview at 3-month follow-up assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.~Higher scores indicate higher/worse levels of PTSD."|3-month follow-up||||scores on a scale||Standard Deviation|Mean
1439822|NCT00937235|Secondary|Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment|"Posttraumatic Symptom Scale Interview at post-treatment assessment, which measures severity of post-traumatic stress disorder (PTSD) symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 51.~Higher scores indicate higher/worse levels of PTSD."|Post-treatment, occurring 12 weeks after the start of treatment (week 0)||||Scores on a scale||Standard Deviation|Mean
1439811|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time|Vital sign assessment of RR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
1439812|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time|Vital sign assessment of HR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
1439813|NCT00937326|Primary|Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time|Vital sign assessment of SBP and DBP was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.|Baseline (Day 1, pre-dose) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
1439814|NCT00937326|Primary|Mean Change From Baseline in Weight Over Time|Participant’s body weight was assessed in the beginning of the study (at Day 1) and at the end of the study (Day 28 and Day 35). The clinical staff was instructed to use calibrated scales for weight measurement. The same scale was used at the clinical site for all participants at each specified time point during the study. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.|Baseline (Day 1) and up to Day 35|Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.|||Kilogram (kg)||Standard Deviation|Mean
1439815|NCT00937326|Primary|Number of Participants With AE by Intensity of Mild, Moderate and Severe|Intensity for each AE was categorized as mild, moderate and severe. Mild was defined as awareness of sign or symptom, but easily tolerated; moderate was defined as discomfort enough to cause interference with normal daily activities; severe was defined as inability to perform normal daily activities.|Up to Follow-up (58 days)|Safety Analysis Set Population.|||Participants|||Count of Participants
1439816|NCT00937326|Primary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. AE's were classified as related to the study medication, based on the investigator's judgment.|Up to Follow-up (58 days)|Safety Analysis Set (SAF) Population was defined as all participants who received at least one dose of any test material during the study.|||Participants|||Count of Participants
1439817|NCT00937235|Secondary|TLFB - Cigarettes Smoked Week Before 3-Month Follow-up|Timeline followback - Number of cigarettes smoked the week before 3-month follow-up visit|3-month follow-up||||Number of Cigarettes Smoked||Standard Deviation|Mean
1439818|NCT00937235|Secondary|TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)|Timeline Followback - Total number of cigarettes smoked the week before Post-Treatment visit|Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit||||Number of Cigarettes Smoked||Standard Deviation|Mean
1439819|NCT00937235|Secondary|Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up|"Hamilton Depression scale (HAM-D) at 3-month followup assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.~Higher scores indicate higher/worse levels of depression."|3-month follow-up||||Scores on a scale||Standard Deviation|Mean
1439820|NCT00937235|Secondary|Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment|"Hamilton Depression scale (HAM-D) at post-treatment assessment, which measures severity of depression symptoms Total scores are displayed and represent summed scores on 17 individual items the scale, and scale range for total scores is 0 to 50.~Higher scores indicate higher/worse levels of depression."|Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0)||||Scores on a scale||Standard Deviation|Mean
1439829|NCT00937105|Secondary|Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins|Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids|up to 1 year|All participants in which valid lens bioburden data was available|||participants|||Number
1439830|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases|Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora|up to 1 year|All participants in which valid lens case bioburden data was available|||participants|||Number
1439831|NCT00937105|Secondary|Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.|Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones|up to 1 year|Number of participants with valid presumed solution induced corneal staining data in each group|||participants|||Number
1439832|NCT00937105|Secondary|Number of Participants With CIE Stratified by Microbial Bioburden on Lenses|Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses|up to 1 year|All participants in which valid lens bioburden data was available|||participants|||Number
1439833|NCT00937105|Primary|Number of Participants Developing a Corneal Inflammatory Event (CIE)|Raw number of participants in each solution arm developing CIE over 12 month follow-up period|up to 1 year|This primary analysis includes the cohort of all 218 randomized participants. The measured values stratify participants by solution group, however, the statistical analysis reports on the entire cohort (both solution groups) consistent with the primary aim of the study.|||participants|||Number
1439834|NCT00937040|Secondary|Epworth Sleepiness Scale (ESS)|The Epworth Sleepiness Scale (ESS) is an 8-item self-rated questionnaire designed to assess the overall level of daytime sleepiness. Each item describes normal daily situations (i.e., watching TV, lying down in the afternoon, sitting inactive in a public place) and subjects rate the likelihood of dozing off or falling asleep in each situation. Responses use a 4-point rating scale (0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing). Item scores are summed to produce a total score (range of 0-24) with lower score suggesting more alertness.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439835|NCT00937040|Secondary|Pittsburgh Sleep Quality Index (PSQI) Total Score|The PSQI discriminates between good and poor sleepers. The self-administered scale contains 15 multiple-choice items concerning frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration over the past month. The PSQI generates 7 scores corresponding to the different sleep domains. Each component score ranges from 0 to 3. Total sleep index is calculated by adding up the 7 component scores (low=0, high=21, the lower the score, the better in sleep quality).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439836|NCT00937040|Secondary|Adult ADHD Self-Report Scale (ASRS) Over Time|The Adult ADHD Self-Report Scale (ASRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the subject's own rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439837|NCT00937040|Secondary|Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires the subject’s DO to answer 4 questions related to how much the subject’s ADHD symptoms have changed since starting the medication, how much benefit was received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. Responses vary from extremely satisfied, very satisfied, satisfied, neutral, mildly dissatisfied, dissatisfied, very dissatisfied, or extremely dissatisfied.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question|||Participants|||Number
1439838|NCT00937040|Secondary|Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale|The Dyadic Adjustment Scale (DAS) completed by DOs who were spouses or significant others assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. Possible responses include 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question DAS subset, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439856|NCT00936975|Primary|Changes in 18F-fluoride PET SUV - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (SUV) in normal bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 normal bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||SUVmax|Participants|Standard Deviation|Mean
1440885|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Lumbar Spine; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data|||Percent change||Inter-Quartile Range|Median
1439839|NCT00937040|Secondary|Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A, as completed by the DO, is a measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of an adult informant familiar with the subject’s functioning. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in nine non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and Global Executive Composite (GEC) are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439840|NCT00937040|Secondary|Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV|The ADHD Rating Scale-IV (Significant Other) is an 18-item list of core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms. Each item is rated on a four point Likert type scale (0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often). The subject’s designated observer will complete this scale, with baseline assessment based on the subject’s usual functioning when not on medication. The total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set and non-missing values at each timepoint. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439841|NCT00937040|Secondary|Clinical Global Impression - Severity of Illness Subscale (CGI-S)|The Clinical Global Impression - Severity of Illness (CGI-S) is a clinician-rated subscale (low=0, high=7, higher score indicates increasing illness). The clinician rates the severity of the ADHD symptoms in relation to the clinician’s total experience with ADHD subjects using a 7-point scale (1=normal, not at all ill, 2= borderline ill, 3= mildly ill, 4=moderately ill, 5= markedly ill, 6= severely ill, 7= among the most extremely ill subjects) in response to the question “Considering your total clinical experience with this particular population, how ill is the subject at this time?”.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439842|NCT00937040|Secondary|Responder Rate Using AISRS|AISRS responder rate is defined as the percentage of subjects with AISRS < 18 at endpoint.|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set|||Percent of participants|||Number
1439843|NCT00937040|Secondary|Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD?|The satisfaction with treatment questionnaire (low=0, high=20, a lower score indicates lower satisfaction with treatment) requires subjects to answer 4 questions related to how much their ADHD symptoms have changed since starting the medication, how much benefit they received from the medication, the extent, if any, the advantages outweighed the disadvantages, and overall satisfaction with the medication. The responses for this question vary with range of satisfaction (e.g. extremely satisfied, very satisfied, satisfied, neutral, dissatisfied, very dissatisfied, or extremely dissatisfied).|Endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set for non-missing response to this question|||Participants|||Number
1439844|NCT00937040|Secondary|Subject's Rating of Dyadic Satisfaction Subscale (DSS)|The Dyadic Adjustment Scale (DAS) assesses the relationship satisfaction or adjustment of partners in committed couple relationships. The 32-question DAS includes 4 empirically validated subscales that measure: dyadic satisfaction, dyadic consensus, dyadic cohesion and affectional expression. The response format varies across the entire scale and includes 5-, 6-, and 7-point Likert-scale questions and two yes/no items. The 10-question subset of the DAS, the Dyadic Satisfaction Subscale, was used in this study (low=0, high=50, higher score means better relationship satisfaction).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439845|NCT00937040|Secondary|Subject's Rating of Endicott Work Productivity Scale (EWPS)|The EWPS provides a measure of the subject’s report of their overall productivity (low=0, high=100, a higher score indicates worsening work productivity and efficiency). There are 25 items (questions 15-39) on the scale that describe types of behaviors/ subjective feelings that are highly likely to reduce work productivity/efficiency. These 25 items are rated on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, to 4=almost always) indicating how often the behavior, feeling or attitude has been manifested in the past week. The total score is the sum of the 25 items.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439846|NCT00937040|Secondary|Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A)|The AIM-A is a subject-reported measure (low=0, high=100, a higher score is more favorable) to assess the overall impact and role that ADHD may have in the conduct of tasks that are expected of adults. The AIM-A is comprised of four global quality of life items, five economic impact items, and five multi-item scales that describe important concepts. Items include: Living with ADHD; General Well-Being; Work, Home and School Performance and Daily Functioning; Relationships; and Communication; and Impact of Symptoms (emotional, degree of daily interference).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439857|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Tumor|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in Tumor. This measurement uses the Patlak method for determining the influx constant.|Baseline and 12 weeks||||mL/min/mL|Participants|Standard Deviation|Mean
1439847|NCT00937040|Secondary|Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)|The BRIEF-A is a self-reported measure (low=61, high=225, lower scores indicate higher executive functioning) capturing views of the subject's own functioning in the everyday environment. The BRIEF-A contains 75 scored items (1=never, 2=sometimes, 3=often) in 9 non-overlapping clinical scales (Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials). The Behavioral Regulation Index (BRI), Metacognition Index (MI), and GEC are then derived.|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||units on a scale||Standard Deviation|Mean
1439848|NCT00937040|Secondary|Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function)|The Symbol Digit Modalities Test (SDMT) is a computerized variant of the Wechsler Digit Symbol Substitution Test (DSST), but the position of symbols and digits is reversed. Scoring is the number of correct responses generated in 2 minutes. Processing Speed Domain = SDMT correct responses - SDMT errors. Higher scores indicate better functioning (i.e. information processing).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||acccurate responses per minute||Standard Deviation|Mean
1439849|NCT00937040|Secondary|Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The SAT is a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The scores generated by the SAT are: correct matches, errors, and response time. The testing score is a measure of cognitive flexibility. Cognitive Flexibility Domain Score = SAT Correct Responses - SAT Errors - Stroop Commission Errors. Higher scores indicate better accuracy.|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||correct responses||Standard Deviation|Mean
1439850|NCT00937040|Secondary|Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function)|The Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The Shifting Attention Test (SAT) a computerized measure of the ability to shift from one instruction set to another quickly and accurately. The Continuous Performance Test (CPT) is a computerized measure of vigilance or sustained attention/attention over time. Vigilance Domain (Complex Attention) Score = Stroop Commission Errors + SAT Errors + CPT Commission Errors + CPT Omission Errors. Lower scores indicate better functioning (i.e. sustained attention).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||errors||Standard Deviation|Mean
1439851|NCT00937040|Secondary|Reaction Time Domain of the Stroop Test (Cognitive and Executive Function)|"Stroop Test is a computerized measure of inhibition/disinhibition, executive function, reaction time, and information processing. The 1st part generates basic reaction time to colors. The 2nd part generates complex reaction time score to matching color names and font color. The 3rd part establishes a Stroop reaction time and an error score to unmatched color names/fonts. Reaction Time Domain Score = (Stroop Complex Reaction Time Correct + Stroop Reaction Time Correct)/2. Lower scores indicate better functioning (i.e. reaction time)."|Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint)|Intent-to-Treat (ITT) analysis set. Only non-missing values are shown at each category (timepoint). Change from baseline to endpoint requires a non-missing value at both baseline and endpoint.|||milliseconds (msec)||Standard Deviation|Mean
1439852|NCT00937040|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis|The Adult ADHD Investigator Symptom Rating Score (AISRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the investigator’s rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The AISRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline, endpoint (42 days or early discontinuation)|Intent-to-Treat (ITT) analysis set was defined as all randomized subjects who have received at least one dose of the study medication and have any post-baseline efficacy data (not including ASRS).|||units on a scale||Standard Deviation|Mean
1439853|NCT00936975|Secondary|Changes in 18F-fluoride Transport (by Patlak Flux) - Normal|Investigation of changes in regional fluoride incorporation as measured by 18F-fluoride transport (Patlak flux) in normal bone. Palak flux is an indicator of blood flow and an indirect marker of angiogenesis.|Baseline and 12 weeks||||mL/min/mL|Participants|Standard Deviation|Mean
1439854|NCT00936975|Primary|Changes in 18F-fluoride Ki - Normal Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in normal bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||mL/min/mL|Participants|Standard Deviation|Mean
1439855|NCT00936975|Primary|Changes in 18F-fluoride Ki - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET (Ki) in tumor bone. Ki represents the net uptake of fluoride to the bone mineral compartment and reflects the level of osteoblastic activity in bone|Baseline and 12 weeks|Analysis population consists of 37 Tumor bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||mL/min/mL|Participants|Standard Deviation|Mean
1439876|NCT00936663|Other Pre-specified|AUC for Proinsulin|Area Under the Curve for Proinsulin after OGTT|1 year||||pmol*hr/L||Standard Error|Mean
1439858|NCT00936975|Primary|Changes in 18F-fluoride PET (SUV) - Tumor Bone|Investigation of changes between baseline and 12 weeks in regional fluoride incorporation as measured by 18F-fluoride PET in tumor bone as measured by SUVmax|Baseline and 12 weeks|Analysis population consists of 37 bone locations in 12 participants who were eligible for the study and had interpretable Pre- and Post-Treatment PET scans|||SUVmax|Participants|Standard Deviation|Mean
1439859|NCT00936910|Secondary|Number of Participants With Negative Cultures on Day 5 and Day 30 During the Test of Cure Period Post Antifungal Lock|Records the number of participants with 2 negative cultures who completed the trial and had (-) test of cure cultures on day 5 and 30|30 days|All children with long term venous access with fungal related central line infections were eligible for enrollment in the trial. No one was excluded because of age, sex, race or ethnicity.|||participants|||Number
1439860|NCT00936910|Secondary|The Development of Fungal-related Complications|Records the number of fungal related adverse complications that occurred|Usually 1-28 days|All children with long term central line access with fungal-related central line infections were eligible for enrollment. No one was excluded due to sex, age, race, or ethnicity|||adverse complications|||Number
1439861|NCT00936910|Secondary|The Number of Days Before the Infected Central Line Culture Becomes Negative|Records the mean number of days required for the cultures to become negative|5 days of antifungal lock treatment|All children with long term venous access with central line fungal related infections were eligible for enrollment in the trial. No one was excluded because of age, sex, or ethinicity|||days||Full Range|Mean
1439862|NCT00936910|Primary|Number of Patients With 2 Negative Fungal Cultures After 5 Days of Combined Systemic Antifungal and Antifungal Lock Therapy and the CVC Was Not Removed|Records the number of patients with 2 negative fungal cultures after 5 days of combined systemic antifungal and antifungal lock therapy and the CVC was not removed|5 days of antifungal lock treatment|13 children with long term central line venous access with positive central line fungal infections were enrolled in the trial.|||Participants|||Count of Participants
1439863|NCT00936897|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data|||Percentage Change From Baseline||95% Confidence Interval|Mean
1439864|NCT00936897|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to Month 12|All randomized subjects using regression imputation for missing post baseline data|||Percentage Change From Baseline||95% Confidence Interval|Mean
1439865|NCT00936897|Secondary|Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1||Baseline to month 1|Randomized subjects who enrolled in the bone marker substudy|||Percentage Change From Baseline||Inter-Quartile Range|Median
1439866|NCT00936897|Primary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12||Baseline to month 12|All randomized subjects using regression imputation for missing post baseline data.|||Percentage Change From Baseline||95% Confidence Interval|Mean
1439867|NCT00936741|Secondary|The Long-term Benefit of Mifepristone Treatment in Cushing’s Syndrome as Measured by Changes in the Score on the Physician’s Global Assessment of Disease Severity|"The mean Investigator’s rating of the change in subject’s signs and symptoms of Cushing’s syndrome from Baseline (Entry into C1073-415) to Endpoint on the Physician’s Global Assessment of Disease Severity was ranked on a 9-point scale (9 = much worse, 7 = worse, 5 = no change, 3 = better, 1 = much better). Higher scores indicate more severe illness. Scoring was done at all visits except the 6 Week Follow-up visit; the final visit result (Endpoint) is reported here.~The instruction was Rate the change in the subject’s signs and symptoms of Cushing’s from Baseline (1 = much better to 9 = much worse)."|Up to three years.||||units on a scale||Standard Deviation|Mean
1439868|NCT00936741|Primary|Number of Participants With Adverse Events|Subjects who received at least one dose of mifepristone were included in the safety analysis.|Up to three years.|Subjects who received one dose of study drug were included in the safety and ITT analyses.|||participants|||Number
1439869|NCT00936715|Primary|Number of Participants Who Had Access to, and Received the Intervention|This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.|Up to 240 weeks|Participants who were enrolled into the study and received study drug.|||Participants|||Count of Participants
1439870|NCT00936702|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from the date of registration to the date at which the participant is removed from treatment due to progression, adverse events, or refusal.|Up to 3 years|All participant who has been removed from treatment due to progression, adverse events, or refusal.|||months||95% Confidence Interval|Median
1439871|NCT00936702|Secondary|Duration of Response|Duration of response was defined for all evaluable participants who have achieved an objective response as the date at which the participant's objective status is first noted to be either CR or PR to the date progression is documented.|Up to 3 years|All eligible participants who have achieved an objective response at which the participant's objective status is first noted to be either CR or PR.|||months||95% Confidence Interval|Median
1439872|NCT00936702|Secondary|Progression-free Survival|The progression-free survival (PFS) was defined as the time from date of registration to the documentation of disease progression or death as a result of any cause, whichever comes first.|Time from registration to the disease progression or death (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).|||months||95% Confidence Interval|Median
1439873|NCT00936702|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause or last follow-up.|Time from registration to death or last follow-up (up to 3 years)|All participants except one who was deemed ineligible (treated prior to registration).|||months||95% Confidence Interval|Median
1439874|NCT00936702|Primary|Percentage of Participants With Confirmed Tumor Responses|"Confirmed tumor response was defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target lesions;~Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;"|First 6 Cycles of treatment (an average of 6 months)|All participants except one who was deemed ineligible (treated prior to registration).|||percentage of participants||95% Confidence Interval|Number
1439875|NCT00936663|Other Pre-specified|AUC for C Peptide|Area Under the Curve for C peptide after OGTT|1 year||||ng*hr/ml||Standard Deviation|Mean
1439883|NCT00936598|Secondary|Daily Analgesic Medication Consumption (Morphine Equivalency)|Analgesic medication consumption will be calculated (morphine equivalent daily dose (MEDD)) on a daily basis using data down loaded from the patient-controlled analgesia (PCA) pump supplemented by information from clinical charts and patient self report on the daily diary form. MEDD starts at zero and does not have an upper limit; higher daily doses indicate more analgesic medication consumption, and thus more pain.|daily from the day of surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.||||||
1439884|NCT00936598|Secondary|Pain Severity Visual Analogue Scale|"Pain severity will be assessed daily following surgery with a visual analogue scale (VAS) completed by participants each night before they go to bed (daily diary PM). VAS pain severity yields a score of 0 to 100, with 100 indicating pain as bad as it could be."|each of the days following surgery until the clinical follow-up appointment|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.||||||
1439885|NCT00936598|Primary|Brief Pain Inventory (Short-form)|Pain intensity and pain interference subscales from the Brief Pain Inventory (Short-form) (BPI) will be used to measure pain over the interval following surgery. Both subscales have a range of 0-10 with higher scores indicating worse outcomes (more intense pain and more pain interference).|at the clinical follow-up appointment approximately 7-10 days after surgery|Due to limited enrollment in this study, and the small amount of data collected, we are unable to produce any significant results or conclusions.||||||
1439886|NCT00936585|Primary|Immunologic Data|Changes in immunological parameters in blood and lamina propria immune cells|Baseline, 6 weeks|All patients in the study were enrolled; not enough patients were enrolled to get enough data to analyze - THERE IS NO DATA as the samples were not processed because not enough patients were enrolled to make any comparison.||||||
1439887|NCT00936481|Secondary|Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls.||at initial visit||||mm||Standard Deviation|Mean
1439888|NCT00936481|Primary|Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls.||at the initial visit||||IU/ml||Standard Error|Mean
1439889|NCT00936455|Secondary|Functional Outcome (mRS(0-1)) at 12 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 12 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
1439890|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 12 months since initial event (2ndary endpoint). The average time per participant relative to the study entry time in units is 12 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
1439891|NCT00936455|Secondary|Recurrent Stroke|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
1439892|NCT00936455|Primary|Functional Outcome (mRS(0-1)) at 6 Months After Index Event. The mRS is the Modified Rankin Scale That Measures Patient's Functional Level of Activity. The Scale is a 6 Point Scale With 0 Score Being Normal and 6 Score Being Death.|Functional Outcome (mRS(0-1)) at 6 months after index event. The mRS is the modified Rankin Scale that measures patient's functional level of activity. The scale is a 6 point scale with 0 score being normal and 6 score being death. Listed below is the number of participants in each group with Functional Outcome (mRS(0-1)).|Patients were all assessed at a single time point (July 2009) for retrospective reporting of how they were at 6 months since initial event (Primary endpoint). The average time per participant relative to the study entry time in concrete units is 6 months|NUMBER OF PARTICIPANTS WAS DETERMINED BASED ON PER PROTOCOL NUMBER OF PATIENT ABLE TO BE CONTACTED VIA TELEPHONE|||participants|||Number
1439893|NCT00936377|Secondary|ICU Length of Stay||The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks||||days||Inter-Quartile Range|Median
1439894|NCT00936377|Secondary|Duration of Study Drug Administration||The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks||||hours||Inter-Quartile Range|Median
1439895|NCT00936377|Secondary|Plasma Epinephrine Concentrations Across Groups Over Time|Plasma epinephrine concentrations|Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug||||ng/mL||Standard Deviation|Mean
1439896|NCT00936377|Secondary|The Occurrence of Adverse Events.|Occurrence of hypotension or bradycardia while on study drug|Seven days||||participants|||Number
1439925|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439897|NCT00936377|Secondary|The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores|Proportion of clinical institute withdrawal assessment (CIWA) Scores listed as severe or moderate 24 Hours after Starting Study Drug. All subjects had at least four CIWA assessments.The CIWA is a ten item scale with each item on the scale scored independently on a 0-7 or 0-4 scale, and the summation of the scores yielding an aggregate value that correlates to the severity of alcohol withdrawal. Ranges of scores are from 0 to 67. Mild alcohol withdrawal is defined with a score less than or equal to 15, moderate with scores of 16 to 20, and severe with any score greater than 20. The ten items evaluated include nausea and vomiting, tremor, sweats, anxiety, agitation, tactile disturbances, auditory disturbances, visual disturbances, headache, and orientation.|Every 2-4 hours for 24 hours after starting study drug||||percentage of ciwa assessment|||Number
1439898|NCT00936377|Primary|Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment||24 hours before treatment, 24 hours after treatment on first day of starting study drug||||mg||Inter-Quartile Range|Median
1439899|NCT00936377|Primary|Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment||12 hours before treatment, 12 hours after treatment on first day of starting study drug||||mg||Inter-Quartile Range|Median
1439900|NCT00936377|Primary|Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal||Seven days||||mg||Inter-Quartile Range|Median
1439901|NCT00936351|Primary|Weeks|Vocational rehabilitation staff tracked weekly work hours verified by supervisors and reported the data to study staff during the 24-week interventions. Therefore possible values for total weeks worked range from 1-24.|weeks 1-24||||total number of weeks||Standard Deviation|Mean
1439902|NCT00936351|Primary|Work Behavior Inventory|"The Work Behavior Inventory (WBI: Bryson, et al., 1997) assesses work performance for persons with severe mental illness based on a trained rater’s observation of participants at work and an interview with their supervisor. Each of the 35 WBI items are rated as 1- 5 (“persistent problem area” to “frequent area of strength”). The total score is the sum of five sub-scales (social skills, cooperativeness, work habits, work quality, and personal presentation). We divided the total score by 35 to produce a mean score that is conducive to interpretation since there are no established cut-offs for interpretation of the total score. Thus the mean scores range from 1-5 and are interpretable based on the anchors for the likert scale ranging from 1 (persistent problem area to 5 (frequent area of strength). Good to excellent interrater reliability was found for raters in this study, with intraclass correlations of .79-.98."|week 24||||units on a scale||Standard Deviation|Mean
1439903|NCT00936351|Primary|Hours|total hours worked over the duration of the 24-week treatment|week 1 through week 24 of treatment|3 participants were not included due to early dropout|||total hours worked during treatment||Standard Deviation|Mean
1439904|NCT00936221|Secondary|Change in Target Lesion Tumour Size at Week 12||randomization to week 12|Intention to Treat (ITT)|||% change||Full Range|Median
1439905|NCT00936221|Secondary|Objective Response Rate|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)|||Participants|||Number
1439906|NCT00936221|Secondary|Progression Free Survival|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment|Intention to Treat (ITT)|||Days||Full Range|Median
1439907|NCT00936221|Primary|Overall Survival|Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.|From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later|Intention to Treat (ITT)|||Days||Full Range|Median
1439908|NCT00936208|Secondary|Change From Baseline in Urinary Microalbuminuria (Urine Dipstick Test Results)|The change from baseline reflects the shift from baseline in urinary dipstick test results to week 24|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the dipstick test at baseline and at week 24|||participants|||Number
1439909|NCT00936208|Secondary|Change in the IRIS II Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
1439910|NCT00936208|Secondary|International Renal Interest Society (IRIS) II Score at Week 24|The IRIS II score represent the risk for vascular complication in type to diabetes mellitus and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the IRIS II score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
1439911|NCT00936208|Secondary|Change in the Framingham Score From Baseline at Week 24|The change from baseline reflects the week 24 value minus the baseline value. The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Baseline and Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
1439912|NCT00936208|Secondary|Framingham Score at Week 24|The Framingham score represent the cardiovascular risk and ranges from 0 (no risk) to 100% (complete risk).|Week 24|Patients of Full Analysis Set (FAS) with values of the framingham score at baseline and at week 24|||Units on a scale||Standard Deviation|Mean
1439915|NCT00936117|Primary|Maximum Observed Concentration in Plasma (Cmax)|"Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day.~Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 – 5000 ng/ml. There are no established therapeutic ranges for posaconazole."|Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.|Of the 11 females enrolled, one was not evaluable for the outcome thus excluded from analysis.|||ng/ml||Full Range|Median
1439916|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
1439917|NCT00936065|Secondary|"Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24"|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory? Percentage of participants who responded yes reported."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Percentage of participants||95% Confidence Interval|Number
1439918|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24|"Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement I would like to continue with my current psoriasis treatment. Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement."|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439919|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439920|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439921|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439922|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439923|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439924|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439926|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439927|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439928|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439929|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439930|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439931|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439932|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439933|NCT00936065|Secondary|Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24|Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Units on a scale||Standard Deviation|Mean
1439934|NCT00936065|Secondary|Change From Baseline in SGA of Itching at Each Visit|Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data|||units on a scale||Standard Deviation|Mean
1439935|NCT00936065|Secondary|Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12 ,18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data|||units on a scale||Standard Deviation|Mean
1439936|NCT00936065|Secondary|Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24|Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data|||units on a scale||Standard Deviation|Mean
1452611|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|End of Study Drug Visit (ESD) (Month 9-24; 263-727 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1439937|NCT00936065|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24|Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of BSA||Standard Deviation|Mean
1439938|NCT00936065|Secondary|Change From Baseline in the PASI Score|Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90–100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section * area score * weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||units on a scale||Standard Deviation|Mean
1439939|NCT00936065|Secondary|Change From Baseline in the PGA of Psoriasis|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.|Baseline, Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF|||units on a scale||Standard Deviation|Mean
1439940|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
1439941|NCT00936065|Secondary|Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
1439942|NCT00936065|Secondary|Time to Achieve a PASI 75 Score|PASI 75 defined as a 75% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
1439943|NCT00936065|Secondary|Time to Achieve a PASI 50 Score|PASI 50 defined as a 50% or greater improvement in PASI score from Baseline|Baseline up to Week 24|mITT|||days||95% Confidence Interval|Median
1439944|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
1439945|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
1439946|NCT00936065|Secondary|Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear|PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence).|Baseline, Weeks 2, 4, 8, 12, 18 and 24|mITT; LOCF|||Percentage of participants||95% Confidence Interval|Number
1439947|NCT00936065|Secondary|Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Weeks 2, 4, 8, 12, 18, and 24|mITT; LOCF|||percentage of participants||95% Confidence Interval|Number
1439948|NCT00936065|Primary|Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24|Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 24|Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)|||percentage of participants||95% Confidence Interval|Number
1441638|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||pg/ml||Standard Deviation|Mean
1439949|NCT00935883|Secondary|Change in Visual Acuity for Geographic Atrophy Group|Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.|Baseline/ 6 Months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||letters||Standard Deviation|Mean
1439950|NCT00935883|Primary|Decrease in Drusen Volume||6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||mm^3||Standard Deviation|Mean
1439951|NCT00935883|Secondary|Change in Visual Acuity for Drusen Group|Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.|Baseline/ 6 Months|Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||letters||Standard Deviation|Mean
1439952|NCT00935883|Primary|Growth of Geographic Atrophy||6 months|Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab|||millimeters||Standard Deviation|Mean
1439953|NCT00935857|Secondary|Procedural Complications|Number of patients with any procedural complications as assessed 7 days after procedure.|7 days post procedure||||participants|||Number
1439954|NCT00935857|Secondary|Time (Minutes) to Cecum|Time, in minutes, until reaching cecum in each arm.|Day of Procedure||||minutes||Standard Deviation|Mean
1439955|NCT00935857|Primary|Complete Colonoscopy to the Cecum|Number of patients with a complete colonoscopy to the cecum|Day of Procedure|Per Protocol, Terminated at Interim Analysis|||patients|||Number
1439956|NCT00935818|Secondary|Point Prevalence Abstinence at 12 Months|Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days|12 months||||participants|||Number
1439957|NCT00935818|Secondary|Prolonged Abstinence at 12 Months||12 months|intention to treat - all subjects|||participants|||Number
1439958|NCT00935818|Secondary|Point Prevalence Abstinence at 6 Months.|Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.|6 months|Intention to treat - all subjects|||participants|||Number
1439959|NCT00935818|Primary|Point Prevalence Abstinence at 3 Months.|biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.|3 months|intent to treat - all subjects|||participants|||Number
1439960|NCT00935818|Secondary|Weight Gain From Baseline to 3 Months|Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit|3 months|analysis was restricted to subjects who had weight measured at the 3 month visit and were classified as meeting criteria for prolonged abstinence|||kilograms||Standard Deviation|Mean
1439961|NCT00935818|Secondary|Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.||6 months|intention to treat - all subjects|||participants|||Number
1439962|NCT00935818|Primary|Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.|Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question “Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?”|3 months|intention-to-treat (all randomized subjects included)|||participants|||Number
1439963|NCT00935792|Secondary|Time to Subsequent Therapy||up to 5 years||||Months||95% Confidence Interval|Median
1439964|NCT00935792|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient’s objective status is first noted to be a Complete Response or Partial Response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier|up to 5 years|These are 8 patients with verified complete or partial responses(used in primary outcome measure) as well as 2 non verified partial responses.|||Months||95% Confidence Interval|Median
1439965|NCT00935792|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier|up to 5 years||||Months||95% Confidence Interval|Median
1439966|NCT00935792|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier|up to 5 years||||Months||95% Confidence Interval|Median
1439967|NCT00935792|Primary|Test the Safety and Tolerability of the Combination of Everolimus and Alemtuzumab.|The number and severity of all adverse events will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion. This will provide an indication of the level of tolerance for this treatment combination in this patient group. Below is the number of patients that experienced a grade 3+ Adverse event that was at least possibly related to Treatment.|Up to 12 months past final treatment||||participants|||Number
1439968|NCT00935792|Primary|Number of Participants With Dose-Limiting Toxicities|"The maximum tolerated dose is the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. Dose-limiting toxicity will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria.~Hematologic: ANC ≤ 0.3 x 109/L or platelet count < 10 x 109/L Other nonhematologic: ≥grade 3 as per NCI Common Terminology Criteria for Adverse Events v3.0 except for fatigue, hyperlipidemia, and hyperglycemia."|1 Month|All phase 1 patients are evaluable|||participants with DLTs|||Number
1439982|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Mean/SD)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use. Mean and standard deviation of outcome were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n= 60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per visit||Standard Deviation|Mean
1439969|NCT00935792|Primary|Clinical Response (Complete or Partial Remission)|CR requires all of the following for a period of at least 2months:Absence of lymphadenopathy.No hepatomegaly or splenomegaly.Absence of constitutional symptoms.• Neutrophils>1500/ul•Platelets>100,000/ul • Hemoglobin >11.0gm/dl• Peripheral blood lymphocytes <4000/uLBonemarrow. normocellular with<30%of nucleated cells being lymphocytes.PR requires two for 2+months.≥50%decrease in peripheral blood lymphocyte count from the pretreatment baseline value.≥ 50%reduction in the sum of the products of the maximal perpendicular diameters of the largest measured node or nodal masses in the right and left cervical, axillary, and inguinal lymph node regions.≥ 50%reduction in size of liver and/or spleen noting the maximal distance below the respective costal margins of palpable hepatosplenomegaly during rest.Neutrophils>1500/ul or50%improvement over baseline. Platelets>100,000/ul or50%increase over baseline. Hemoglobin>11.0 gm/dl or50%increase over baseline without transfusions|After 2 courses of treatment|All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.|||participants|||Number
1439970|NCT00935766|Primary|Change in Pulse Wave Velocity in Active vs. Placebo-treated Patients.|We conducted a prospective, randomized; double-blinded study of omega-3 fatty acids among 60 Latino and White hypertensive patients at risk for CVD. Patients received either 4-g omega–3 fatty acids or matched placebo daily. The principal outcome measure was change in brachial-ankle PWV.|Baseline, 3 months||||cm/sec||Standard Deviation|Mean
1439971|NCT00935766|Secondary|Change in hsCRP||baseline, 3 months||||mg/L||Standard Deviation|Mean
1439972|NCT00935766|Secondary|Change in Lipoprotein-associated Phospholipase A2 (LpPLA2)||baseline, 3 months||||ng/mL||Standard Deviation|Mean
1439973|NCT00935701|Secondary|Change in Parenting Stress Index|The Parenting Stress Index (PSI) was designed for parents of children ages 1:6 to 12:5 and identifies stressors in the parent-child relationship. Specifically, the PSI measures child’s characteristics on six subscales, which are summed get a total score in the child domain (47 to 235). The PSI also has seven subscales that measure parent characteristics, and are summed to get a total score in the parent domain (54 to 270). The totals from the parent and child domains are summed for a total stress score (101 to 505). Higher scores indicate a higher level of stress. Pre scores were subtracted from post scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1439974|NCT00935701|Secondary|Change in Children's Sleep Habits Questionnaire|The Children’s Sleep Habits Questionnaire (CSHQ) assesses sleep problems common in school-age children and is comprised of eight subscales. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. Subscale scores from pre intervention were subtracted from post subscale scores in order to get the change in scores.|Pre intervention (baseline), post intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
1439975|NCT00935701|Secondary|Change in Conners' Rating Scales|The Conners’ Rating Scales Revised (CRS-R) is used to assess attention deficit hyperactivity disorder (ADHD) as well as other related behavioral concerns. The CRS-R is made up of 14 scales. Analysis was done on 6 of these scales: Conners' Global Index Restless-Impulsive, Conners' Global Index Emotional Lability, Conners' Global Index Total, DSM-IV Inattentive, DSM-IV Hyperactive-Impulsive, and DSM-IV Total. Raw scores are converted to T-scores, based on age and gender of the child. A high T-score indicates a greater number and/or frequency of reported concerns. Pre T-scores were subtracted from post T-scores to calculate the change in T-score.|Pre intervention (baseline), post intervention (8 weeks)||||t-scores||Standard Deviation|Mean
1439976|NCT00935701|Primary|Proportions of Children Completing Acupressure and Acupuncture Treatment.||2 months into Phase 1|Participants who transitioned from acupressure to acupuncture were assessed.|||participants|||Number
1439977|NCT00935649|Secondary|Mycology|KOH, PCR and cultures of patients who were bilaterally positive or negative for each test.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.||||||
1439978|NCT00935649|Primary|Nail Bed Clearing|Change in amount of clear nail over time.|48 weeks|There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.||||||
1439979|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Median/Range)|For EMR use, we assessed the change in the average number of mouse clicks per minute per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per minute per visit||Full Range|Median
1439980|NCT00935584|Primary|Change in EMR Mouse Click Per Minute Per Visit (Mean/SD)||Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=56 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per minute per visit||Standard Deviation|Mean
1439981|NCT00935584|Primary|Change in Total Number of EMR Mouse Click Per Visit (Median/Range)|For EMR use, we assessed the change in total number of mouse click per-visit, positive score indicates increased EMR use.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=60 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=119) using all available data.|||EMR mouse clicks per visit||Full Range|Median
1439995|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=7%|Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.|||percentage of subjects|||Number
1439983|NCT00935584|Primary|Change in Patient Engagement|Change in proportion of time spent on physician-patient communication from pre to post-intervention clinic visit was calculated. Positive change indicates increased time spent on patient communication. Mean and standard deviation of outcomes were reported in this table.|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (n=72 for the outcomes reported below) only and mixed model method was used to analyze the subjects (n=125) using all available data.|||percentage of total visit time||Standard Deviation|Mean
1439984|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Median/Range)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.~Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Median and range were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.|||units on a scale||Full Range|Median
1439985|NCT00935584|Primary|Change in Patient's Satisfaction, Change in Provider's Satisfaction (Mean/SD)|"Three patient satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures physician's use of patient center communication; Subscale 2 measures clinical competence and skills; Subscale 3 measures physician interpersonal skills. Four provider satisfaction subscales were analyzed (range 1-5 for all subscales, 1=not satisfied at all, 5=very satisfied). Subscale 1 measures quality of physician-patient relation; Subscale 2 measures patient's non-demanding co-operative nature, Subscale 3 measures satisfaction with data collection; Subscale 4 measures satisfaction with use of visit time.~Change in patient's satisfaction and change in provider's satisfaction from pre to post-intervention clinic visit was reported for the above subscales. Higher change score indicates better outcome. Mean and standard deviation were reported."|Baseline clinic visit and post-intervention clinic visit (over a period of 1 year)|Wilcoxon signed rank test was used to analyzed the subjects using complete data (ranges from 63 to 73 for the outcomes reported below) only and mixed model method was used to analyze the subjects (ranges from 108 to126) using all available data.|||units on a scale||Standard Deviation|Mean
1439986|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.|||events per subject-year||Standard Error|Mean
1439987|NCT00935532|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.|Baseline to Week 26|FAS Population.|||events per subject-year||Standard Error|Mean
1439988|NCT00935532|Secondary|Change in Blood Pressure From Baseline to Endpoint (Week 26)|Change in Blood Pressure from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mmHg||Standard Deviation|Mean
1439989|NCT00935532|Secondary|Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline|Ratio of Triglycerides (measured in mg/dL) at endpoint (Week 26) to Baseline. Log(Postbaseline Triglycerides) - log(Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
1439990|NCT00935532|Secondary|Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)|Change in HDL-C from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mg/dL||Standard Error|Least Squares Mean
1439991|NCT00935532|Secondary|Change in Total Cholesterol From Baseline to Endpoint (Week 26)|Change in Total Cholesterol from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mg/dL||Standard Error|Least Squares Mean
1439992|NCT00935532|Secondary|Change in Body Weight From Baseline to Endpoint (Week 26)|Change in Body Weight from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||kg||Standard Error|Least Squares Mean
1439993|NCT00935532|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)|Change in FSG (centralized measurement) from baseline to endpoint (Week 26)|Baseline, Week 26|FAS Population. Missing data at endpoint was imputed using LOCF approach.|||mg/dL||Standard Error|Least Squares Mean
1439994|NCT00935532|Secondary|Percentage of Subjects Achieving HbA1c<=6.5%|Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)|Baseline, Week 26|FAS Population. Only subjects with baseline HbA1c > target were included in calculation. Missing data at endpoint was imputed using LOCF approach.|||percentage of subjects|||Number
1440007|NCT00935259|Secondary|Blood Linoleic Acid Levels|Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.|2 weeks|Only participants with complete blood linoleic acid data were included.|||nmol||Standard Deviation|Mean
1439996|NCT00935532|Primary|Change in HbA1c From Baseline to Endpoint (Week 26)|Change in HbA1c from baseline to endpoint (Week 26).|Baseline, Week 26|Statistical analysis of this study was performed for the full analysis set (FAS). FAS consisted of randomized patients who received administration of the study drug at least once and had measurement values after administration. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1439997|NCT00935493|Secondary|Quality of Life (SF-36 MCS)|"Quality of Life (QOL) was assessed using the SF-36 (36-Item Short-Form Health Survey; QualityMetric, Lincoln, RI), MCS subscale. The SF-36 is a self-administered general health-related quality of life scale with 36 items. The MCS subscale has been shown to be responsive in psychoactive drug trials. The score range is 0-100.~Higher scores represent better mental health; therefore, the least squares means listed here represent mean outcome changes from baseline."|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow up|||units on a scale||Standard Error|Least Squares Mean
1439998|NCT00935493|Secondary|Alzheimer’s Disease Cooperative Study—Clinical Global Impression of Change (ADCS-CGIC)|The seven-point scale was collapsed into 3 groups and coded as a three-level ordinal scale of global status, representing ordered levels of worse (including minimally, moderately and markedly worse), unchanged, and improved (including minimally, moderately, and markedly improved) global status.|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks of follow-up|||participants|||Number
1439999|NCT00935493|Primary|Mean in the Prefrontal Executive Function Z-score (PEF6_6)|"The primary outcome measure (PEF6_Z) is the mean of z-scores for 6 executive function tasks (CANTAB: Spatial Working Memory, Stockings of Cambridge, Intradimensiona/Extradimensional Shift, Paired Associates Learning; Stroop Color Word Score, Trail Making Test – B).~The score is composed of six component scales coded as z scores that measures cognitive functioning in which higher scores represent better cognitive functioning; therefore, the least squares means listed here represent mean outcome changes from baseline"|12 weeks|119 of the 123 trial participants had outcome data recorded at 12 weeks follow-up.|||Z-score||Standard Error|Least Squares Mean
1440000|NCT00935311|Secondary|Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1440001|NCT00935311|Secondary|Time to First Rescue Medication|The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||minutes||95% Confidence Interval|Median
1440002|NCT00935311|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
1440003|NCT00935311|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
1440004|NCT00935272|Secondary|Percentage of Participants With a Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at post-baseline time points as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at weeks 12, 16, 20 and 24|For this secondary objective, the pool of participants analyzed was based on 135 from the Intent to Treat population. However the analysis was done with the number of subjects with non-missing data. This number varied for each timepoint.|||Percent of responders||95% Confidence Interval|Number
1440005|NCT00935272|Primary|Percentage of Participants With Response|Assessment of lip fullness augmentation after treatment with Restylane, as compared to no treatment, at week 8 as compared to baseline assessment. Response was determined by at least one grade improvement from baseline in the upper and lower lips using the Medicis Lip Fullness Scale (MLFS). The MLFS is a 5 number scale with grading: (1) Very Thin, (2) Thin (3) Medium (4) Full and (5)Very Full.|Baseline and at 8 weeks|Analysis was ITT; Sample size based upon a one-sided Fisher's Exact test with alpha = 0.05; Subjects with a missing Blinded Evaluator assessment as Week 8 were imputed using the hot deck method|||Percentage of Participants||95% Confidence Interval|Number
1440006|NCT00935259|Secondary|Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo|Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.|2 weeks|Only participants with complete fasting delta 5 desaturase enzyme activity data were included.|||ratio||Standard Deviation|Mean
1440008|NCT00935259|Secondary|Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level|"Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio [dose = 162 g/m^2]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.~The mean reported was an adjusted mean (defined in first outcome measure)."|2 weeks|Only participants with complete PCSK9 data were included.|||nmol||Standard Deviation|Mean
1440009|NCT00935259|Secondary|Fasting Blood Lipidomic Levels After 2 Weeks of Treatment|"Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.~The mean reported was an adjusted mean."|2 weeks|"Only participants with complete blood lipidomic data were included.~For cholesterol ester 22:5n6, n=26 for the simvastatin arm and n=27 for the placebo arm."|||nmol||Standard Deviation|Mean
1440010|NCT00935259|Primary|Arachidonic Acid Level After 2 Weeks of Treatment|"Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.~The mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term."|2 weeks|Only participants with complete arachidonic acid data were included.|||nmol||Standard Deviation|Mean
1440011|NCT00935220|Secondary|DPP-4 Inhibition: E_24|Plasma DPP-4 inhibition 24 hours after first dose. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration|Treated set|||Percent (of inhibition)||Full Range|Median
1440012|NCT00935220|Secondary|Linagliptin: C_max|maximum concentration of linagliptin in plasma on Day 1|24h|Treated set - All patients with values for the maximum measured concentration of linagliptin in plasma (C_max)|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1440013|NCT00935220|Primary|DPP-4 Inhibition: E_24,ss|Plasma DPP-4 inhibition at trough under steady state conditions. Plasma DPP-4 inhibition is derived by calculating (1-(activity in presence of linagliptin)/baseline activity))*100%, where 'activity' is the activity of the DPP-IV enzyme.|One single measurement 24 h after drug administration under steady state conditions|Treated set|||Percent (of inhibition)||Full Range|Median
1440014|NCT00935220|Secondary|Linagliptin: AUC_0-24|area under the concentration time curve of linagliptin in plasma over the time interval from 0 to 24h after administration of the first dose|24 hours|Treated set- All patients with values for the area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose (AUC_0-24) for Linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1440015|NCT00935220|Secondary|Patients With Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities Reported as an Adverse Event|Patients with Electrocardiogram (ECG), vital signs, physical finding reported as an adverse event|21 days|All treated patients|||Participants|||Number
1440016|NCT00935220|Primary|Linagliptin: C_max,ss|maximum concentration of linagliptin in plasma at steady state|24 hours|Treated set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1440017|NCT00935220|Primary|Linagliptin: AUC_τ,ss|area under the concentration time curve (AUC_τ) of linagliptin in plasma at steady state over a uniform dosing interval|24 hours|Treated set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1440018|NCT00935220|Secondary|Electrocardiogram (ECG), Vital Signs, Physical Finding or Laboratory Finding Abnormalities|12-lead-Electrocardiogram (ECG), vital sign (blood pressure and pulse rate), physical finding and laboratory abnormalities|21 days|All treated patients|||Participants|||Number
1440019|NCT00935220|Secondary|Treatment Emergent Adverse Events|Frequency of patients with AEs|21 days|All treated patients|||Participants|||Number
1440020|NCT00935064|Primary|Expiration/Inspiration Ratio Before and After Treatment|Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles.|baseline and 6 weeks||||Ratio||Standard Deviation|Mean
1440021|NCT00935064|Primary|Mean Circular Resultant Before and After Treatment|Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable.|baseline and 6 weeks||||MCR is unitless||Standard Deviation|Mean
1440022|NCT00935064|Primary|Serum Renin Level Before and After Treatment|Serum renin level at baseline and follow-up|baseline and 6 weeks||||ug/l/h||Standard Deviation|Mean
1440023|NCT00935064|Primary|Diastolic Blood Pressure Before and After Treatment|Diastolic blood pressure at baseline and follow-up.|baseline and 6 weeks||||mm Hg||Standard Deviation|Mean
1440024|NCT00935064|Primary|Systolic Blood Pressure Before and After Treatment|Systolic blood pressure at baseline and follow-up|baseline and 6 weeks||||mm Hg||Standard Deviation|Mean
1440025|NCT00934947|Secondary|Anxiety Symptoms|Anxiety severity via the State Trait Personality Inventory (STPI), range 10-40, 40 represents high anxiety.|6 weeks after injury was chosen as the main timepoint of interest|The number of patients represents the number of participants responding at 6 weeks after injury.|||units on scale||Standard Deviation|Mean
1440026|NCT00934947|Secondary|Itch Symptoms|Average itch intensity measured with a 0-10 numeric rating scale, 6 weeks was used as main outcome timepoint for itch symptom burden. 0 represents no itch symptoms and 10 represents the most severe itch symptoms.|Week 6 after injury was chosen as the main timepoint of interest|The number of participants who reported itch at the 6 week time point are included in the analysis.|||units on a scale||Standard Deviation|Mean
1440027|NCT00934947|Secondary|Sleep Quality|Medical Outcomes Survey Sleep Quality Subscale. This is a 0-10 numeric rating scale in which patients rate their sleep quality. 0 represents poor sleep quality whereas 10 represents a restful night of sleep.|6 weeks after injury timepoint was chosen for this analysis|The number of participants who reported sleep quality at the 6 week time point are included in the analysis.|||units on a scale||Standard Deviation|Mean
1440028|NCT00934947|Primary|Overall Pain Trajectory Slopes|Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.|Study days 5, 7, 10, 13, 17 and 19||||Numeric Rating Scale Score Change/Day||95% Confidence Interval|Least Squares Mean
1440029|NCT00934921|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1440030|NCT00934921|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1440031|NCT00934921|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1440032|NCT00934856|Secondary|Vss of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||liters per square meter (L/m^2)||Standard Deviation|Mean
1440033|NCT00934856|Secondary|CL of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||liters/hour/square meter (L/hr/m^2)||Standard Deviation|Mean
1440034|NCT00934856|Secondary|AUCinf of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||hr*ng/mL||Standard Deviation|Mean
1440035|NCT00934856|Secondary|t1/2 of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per SmPC)|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||hours (hr)||Standard Deviation|Mean
1440036|NCT00934856|Secondary|Cmax of Plasma Docetaxel|Docetaxel infusion duration = 1 hr (as per summary of product characteristics [SmPC])|Cycle 1: pre-dose (Hr 0), 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1. Cycle 2: pre-dose (Hr 0), 0.5 hr and 59 min after start of infusion, 0.25, 0.5, 1, 2, 4, 8, 23 hrs post EOI of docetaxel on Day 1 (1 cycle = 21 days)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||ng/mL||Standard Deviation|Mean
1440037|NCT00934856|Secondary|AUCinf of Plasma DM1||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||day*ng/mL||Standard Deviation|Mean
1440038|NCT00934856|Secondary|t1/2 of Plasma DM1||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||days||Standard Deviation|Mean
1440039|NCT00934856|Secondary|Cmax of Plasma N2’-Deacetyl-N2’-(3-mercapto-1-oxopropyl)-Maytansine (DM1)|DM1 is the metabolite of trastuzumab emtansine.|Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1440040|NCT00934856|Secondary|Vss of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mL/kg||Standard Deviation|Mean
1440041|NCT00934856|Secondary|CL of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mL/day/kg||Standard Deviation|Mean
1440042|NCT00934856|Secondary|AUCinf of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||day*mcg/mL||Standard Deviation|Mean
1440043|NCT00934856|Secondary|t1/2 of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||days||Standard Deviation|Mean
1440044|NCT00934856|Secondary|Cmax of Total Serum Trastuzumab||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mcg/mL||Standard Deviation|Mean
1440045|NCT00934856|Secondary|Volume of Distribution at Steady State (Vss) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||mL/kg||Standard Deviation|Mean
1440046|NCT00934856|Secondary|Clearance (CL) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||milliliters/day/kilogram (mL/day/kg)||Standard Deviation|Mean
1440047|NCT00934856|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||day*mcg/mL||Standard Deviation|Mean
1440048|NCT00934856|Secondary|Apparent Terminal Half-Life (t1/2) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|PK analysis population. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified cycle for each arm.|||days||Standard Deviation|Mean
1440049|NCT00934856|Secondary|Maximum Observed Concentration (Cmax) of Serum Trastuzumab Emtansine||Cycle 1: pre-dose (Hour [Hr] 0), 0.25, 4 hrs post end of infusion (EOI) of T-DM1 on Day 2; on Days 3 and 8. Cycle 2: pre-dose (Hr 0), 0.25, 4 hrs post EOI of T-DM1 on Day 1; on Day 8 (1 cycle = 21 days) (T-DM1 infusion duration = 1.5 hrs)|Pharmacokinetic (PK) analysis population: PK-evaluable participants were defined as participants who received at least one dose of T-DM1 or docetaxel with at least one post-dose concentration data point. Number analyzed = participants evaluable for specified cycle for each arm.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1440050|NCT00934856|Secondary|Number of Participants With Anti-Therapeutic Antibody (ATA) Response to Trastuzumab - MBC and LABC Population|Number of participants with ATA response was reported. Data for this outcome measure was planned to be reported for overall MBC and LABC participants and not by individual treatment arms.|Baseline (Day 1 of Cycle 1), Post baseline (at first follow-up visit [28 days after last dose of study drug][up to approximately 145 weeks])|All participants who received at least one dose of study medication were included. Here, number analyzed=participants evaluable for ATA at specified time-point.|||participants|||Number
1440051|NCT00934856|Secondary|Percentage of Participants With a BOR of CR or PR - LABC Population|BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% Cl was determined using the Pearson-Clopper method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|LABC population|||percentage of participants||95% Confidence Interval|Number
1440052|NCT00934856|Secondary|Percentage of Participants With Pathological CR (pCR) - LABC Population|The pCR was defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants and lymph nodes after surgery following primary systemic therapy.|Within 6 weeks of post-surgery (up to approximately 3 years)|LABC population: All participants with LABC who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1440092|NCT00934596|Secondary|De-airing Time After Cardiac Ejection|The duration in minutes of the period after cardiac ejection to finished de-airing procedure.|During de-airing procedure||||minutes||Inter-Quartile Range|Median
1440385|NCT00932126|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
1440053|NCT00934856|Secondary|Duration of Response - MBC Population|Duration of response was calculated for participants with CR or PR based on the RECIST v1.0 criteria. Duration of response was defined as the time interval between the date the CR or PR was first recorded and the date on which PD was first noted or date of death, whichever occurred first. Participants with no documented PD after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively. Median duration of response was estimated using the Kaplan-Meier method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|MBC population|||months||Full Range|Median
1440054|NCT00934856|Secondary|Percentage of Participants With CR or PR or Stable Disease (SD) for at Least 6 Months [Clinical Benefit Rate (CBR)] - MBC Population|CBR was defined as percentage of participants experiencing SD of at least 6 months from the start of treatment plus CR or PR according to the RECIST v1.0 criteria. For TLs: CR- disappearance of all TLs. PR- at least 30% decrease in the sum of LDs of the TLs, taking as a reference the BL sum of LDs. PD- at least 20% increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. SD- neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For NTLs: CR- disappearance of all NTLs and normalization of tumor marker levels. SD- persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Percentage of participants= number of participants with CR/PR/SD divided by total number of participants, and then multiplied by 100. 95% CI was determined using the Pearson-Clopper method.|Baseline until disease progression, recurrence or death (up to approximately 3 years)|MBC population|||percentage of participants||95% Confidence Interval|Number
1440055|NCT00934856|Secondary|Time to Treatment Failure (TTF) - MBC Population|TTF was defined as the time interval between the date of start of treatment and the date of PD, death from any cause, withdrawal from study treatment, or initiation of non-protocol anti-cancer therapy, whichever occurred first. Participants without an event at the time of the analysis were censored at the date of the last follow-up assessment. Median TTF was estimated using the Kaplan-Meier method.|Baseline until end of treatment (up to 39.8 months)|MBC population|||months||Full Range|Median
1440056|NCT00934856|Secondary|Percentage of Participants With Treatment Failure - MBC Population|Treatment failure was defined as the discontinuation of treatment for any reason, including the following qualifying events: PD, death from any cause, withdrawal from study treatment, or initiation of nonprotocol anti-cancer therapy. Percentage of participants with treatment failure was calculated as the (number of participants with treatment failure) divided by (total number of participants), and then multiplied by 100.|Baseline until end of treatment (up to 39.8 months)|MBC population|||percentage of participants|||Number
1440057|NCT00934856|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) - MBC Population|BOR was defined as CR or PR recorded from baseline until disease progression/recurrence according to RECIST v1.0 criteria. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the sum of LDs of the TLs, taking as a reference the baseline (BL) sum of LDs. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Percentage of participants with BOR rate was calculated as the (number of participants with CR or PR) divided by (total number of participants), and then multiplied by 100. The 95% confidence interval (Cl) was determined using the Pearson-Clopper method.|Baseline until disease progression or recurrence (up to approximately 3 years)|MBC population|||percentage of participants||95% Confidence Interval|Number
1440058|NCT00934856|Secondary|PFS - MBC Population|PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of PD or death from any cause, whichever occurred first. Response was based on RECIST v1.0. For TLs, PD was at least a 20 % increase in the sum of LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For NTLs, PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Median PFS time was calculated using Kaplan-Meier estimates. Data for participants without PD or death was censored at the time of the last response assessment.|Baseline until disease progression or death (up to approximately 3 years)|MBC population|||months||Full Range|Median
1440059|NCT00934856|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Event - MBC Population|PFS was defined as the time interval between the date of the start of treatment and the date of first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Response was based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 (v1.0). For target lesions (TLs), PD was at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. For non-target lesions (NTLs), PD was the appearance of one or more new lesions and/or unequivocal progression of existing NTLs. Data for participants without PD or death was censored at the time of the last response assessment. Percentage of participants with PFS event was calculated as the (number of participants with PFS event [PD or death]) divided by (total number of participants), and then multiplied by 100.|Baseline until disease progression or death (up to approximately 3 years)|MBC population: All participants with MBC who received at least one dose of study medication were included.|||percentage of participants|||Number
1440060|NCT00934856|Primary|Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs) - MBC and LABC Population|An AE is any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Baseline up to 28 days after last dose for MBC participants and for LABC participants who could not undergo surgery, and up to 6 weeks post-surgery for LABC participants who underwent surgery (maximum up to approximately 3 years)|All participants who received at least one dose of study medication were included.|||percentage of participants|||Number
1440162|NCT00933335|Secondary|Time to Death of Participants During Their Participation in the Study|Time to death is defined as the time from the treatment start date to the date of death.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population|||months||95% Confidence Interval|Median
1440061|NCT00934856|Primary|Number of Participants With Dose Limiting Toxicity (DLT) - MBC and LABC Feasibility Population|DLTs included (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] grading): Grade 4 thrombocytopenia, thrombocytopenia of any grade with concurrent hemorrhage or requiring blood platelet transfusion, or thrombocytopenia not recovered by Day 21 to at least 100,000/microliter (mcL); Grade 4 neutropenia lasting for more than 7 days; Febrile neutropenia; Grade greater than or equal to (>/=) 3 neurotoxicity in the form of peripheral neuropathy or peripheral neurotoxicity not improving to baseline or Grade less than or equal to (</=) 1 by Day 21; Any non-hematological toxicity of Grade >/= 3 except for alopecia, fever, and chills, not improving to baseline or Grade </=1 by Day 21, despite adequate toxicity management; Any subjective intolerable toxicity felt by the investigator to be related to either study treatment; Any other treatment-related toxicity prohibiting the start of the Cycle 2 on Day 22; Fulminant skin rash.|Cycle 1 (up to 21 days)|MBC and LABC feasibility population: All participants who received at least one dose of study medication and included in the feasibility part of the study.|||participants|||Number
1440062|NCT00934843|Secondary|Total Intake/Output of Fluid|Total amount of all fluids in and out during the first 36 hours postoperatively in mL.|over 36 hours||||mL||Standard Deviation|Mean
1440063|NCT00934843|Secondary|Urine Output|Total urine output in mL over the first 36 hours after cardiac surgery|over 36 hours||||mL||Standard Deviation|Mean
1440064|NCT00934843|Secondary|Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery|Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery|at 36 hours and 30 days||||participants|||Number
1440065|NCT00934843|Secondary|Inotropic Score|The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score.|over the first 36 hours after surgery||||Scores on a scale||Standard Deviation|Mean
1440066|NCT00934843|Primary|Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery.|The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support.|36 hours||||participants|||Number
1440067|NCT00934791|Primary|Liver Volume at 2 Years After Kidney Transplantation|Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).|2 years|This study was terminated due to inadequate enrollment, no data was collected on the participant.||||||
1440068|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|4 Days Post Surgery||||units on a scale||Standard Deviation|Mean
1440069|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|3 Days Post Surgery||||units on a scale||Standard Deviation|Mean
1440070|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|2 Days Post Surgery||||units on a scale||Standard Deviation|Mean
1440071|NCT00934661|Secondary|Verbal Pain Scores Post-gait|Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.|1 day post surgery|16 participants were analyzed in both the Extended Release Epidural Morphine and the Placebo Group for active pain scores. 17 participants overall were analyzed for the Extended Release Epidural Morphine and 18 participants overall were analyzed for the Placebo Group.|||units on a scale||Standard Deviation|Mean
1440072|NCT00934661|Secondary|Distance Walked at Walking Test|Distance walked at walking test. Longer distance walked represent better outcomes|96 hours|"Different amount of observations were different at each visit. Data for Post Surgery Day 4 for the Extended Release Epidural Morphine was not collected."|||Steps||Standard Deviation|Mean
1440073|NCT00934661|Secondary|Patient Satisfaction Score|Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.|96 hours|17 participants in the Extended Release Epidural Morphine group and 18 participants in the placebo group provided Verbal satisfaction scores|||units on a scale||Standard Deviation|Mean
1440074|NCT00934661|Secondary|Total Opioid Consumption|Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.)|96 hours||||mg||Standard Deviation|Mean
1440075|NCT00934661|Primary|Length of Hospital Stay After Surgery||From surgery day to hospital discharge||||Days||Standard Deviation|Mean
1440076|NCT00934648|Secondary|Percentage of Participants With Changes in Bone Density|Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.|Screening, Weeks 48 and 104|ITT population|||percentage of participants|||Number
1440163|NCT00933335|Secondary|Number of Participants Who Died During Their Participation in the Study|Participants who died during the study period were evaluated for the overall survival endpoint.|Day of TST/I 131 TST dosimetric dose to date of database release (Week 1 to Week 520); First day of fludarabine cycle 1 to date of database release (Week -16 to Week 520)|ITT-Exposed Population|||participants|||Number
1440077|NCT00934648|Secondary|Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category|DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Screening, Day 1, and Weeks 24 and 104|ITT population|||percentage of participants|||Number
1440078|NCT00934648|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity.|Day 1 and Week 24|ITT population|||scores on a scale||Standard Deviation|Mean
1440079|NCT00934648|Primary|Percentage of Participants With an Adverse Event (AE)||Week 104|Safety population: included all participants who have received any part of an infusion of the study medication.|||percentage of participants|||Number
1440080|NCT00934635|Secondary|Assessment of the Ratio of Dopamine D2-receptor Occupancies in Two Different Areas of the Brain|No measures available due to early termination of trial|Analysis of PET scans at Visit 3 (day 3)|||||||
1440081|NCT00934635|Secondary|Plasma Concentrations of Paliperidone and Risperidone|No measures available due to early termination of trial|Measurement of plasma concentration at Visit 3 (day 3)|||||||
1440082|NCT00934635|Primary|Percentage of Paliperidone or Risperidone Dopamine D2 Receptor Occupancies||Visit 3 (on day 3)|PET imaging data were not submitted for further analysis. D2-receptor occupancies could not be calculated due to the low number of subjects in the healthy control group.|||percentage|||Number
1440083|NCT00934622|Secondary|Spectacle Independence|Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.|pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery|Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.|||Percentage of Participants|||Number
1440084|NCT00934622|Primary|Visual Acuity|Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery||||logMAR||Standard Deviation|Mean
1440085|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|6-10 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.|||participants|||Number
1440086|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|3-6 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.|||participants|||Number
1440087|NCT00934596|Primary|Number of Participants With <=Grade I Gas Emboli as Assessed by Trans-esophageal Echocardiography TEE).|Grade 0, no residual gas emboli; grade I, gas emboli observed in 1 of the 3 anatomic areas - left atrium, left ventricle or aortic root during 1 cardiac cycle; grade II, gas emboli observed simultaneously in 2 of the 3 anatomic areas during 1 cardiac cycle; grade III, gas emboli observed simultaneously in all 3 anatomic areas during 1 cardiac cycle.|0-3 minutes after end of cardiopulmonary bypass|The number was determined before hand as per protocoll.|||participants|||Number
1440088|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|During 10 minutes after cardiopulmonary bypass||||Air Microemboli||Standard Deviation|Mean
1440089|NCT00934596|Secondary|pH at 45 Min of CPB|pH measured by arterial bloodgas at 45 minutes of CPB, comparison between groups|Intraoperative||||units on a scale||Inter-Quartile Range|Median
1440090|NCT00934596|Post-Hoc|Fraction of Morphologically Damaged Red Blood Cells as Assessed by Scanning Electron Microscopy Studies.|Pieces of tubing from the cardiopulmonary circuit were prepared and photographed in a Scanning Electron Microscope. Visual inspection of each photograph by an investigator blinded to which group the photograph belonged to was performed. The proportion of damaged red blood cells over the total number of red blood cells were calculated.|Pieces of tubing collected after weaning from cardiopulmonary bypass|Samples were collected from 5 participants in each Group (total of 10 participants). For each participant 4 pieces of tubing were collected (20 pieces in each Group, total 40 pieces). Samples were photographed. One photograph from each individual was randomly selected and studied by an investigator blinded to Group (total of 10 photographs).|||Fraction of Damaged Red Blood Cells||95% Confidence Interval|Mean
1440091|NCT00934596|Secondary|Oxygenator Gas Flow at 45 Minutes of CPB|The amount of carbon dioxide gas flow through the oxygenator was measured and compared between groups.|Intraoperative||||L/minute||Inter-Quartile Range|Median
1440093|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|After cardiac ejection||||Air Microemboli||Standard Deviation|Mean
1440094|NCT00934596|Secondary|De-airing Time Before Cardiac Ejection|Time in minutes starting at t1 (removal of aortic cross clamp) and ending at t2 (beginning of cardiac ejection).|Measured during intraoperative course||||minutes||Inter-Quartile Range|Median
1440095|NCT00934596|Secondary|Total Time Required for De-airing|The total de-airing time as measured in minutes.|After removal of aortic cross-clamp to complete de-airing, an average of 11 minutes||||Minutes||Inter-Quartile Range|Median
1440096|NCT00934596|Primary|Number of Air Microemboli Registered Over the Middle Cerebral Arteries by On-line Trans-cranial Echo-Doppler (TCD).|The number of air microemboli (also referred to as gaseous microembolic signals) was concomitantly counted in the right and left medial cerebral artery. The number of signals from the right and the left medial cerebral artery were summed, and presented as the total sum of the gaseous micromebolic signals from the right and left side. Counting of gaseous microembolic signals was done during three time intervals: Before cardiac ejection, after cardiac ejection and during 10 minutes after cardiopulmonary bypass.|Before cardiac ejection||||Air Microemboli||Standard Deviation|Mean
1440097|NCT00934544|Secondary|Percentage of Participants With Bone Marrow Histomorphology at Week 48|This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used.|48 weeks|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria.|||Percentage of participants|||Number
1440098|NCT00934544|Secondary|Overall Survival (OS) by Treatment|Defined as the interval between randomization and death from any cause. Hazard ratios of OS and the corresponding 95% CIs were estimated using the Cox proportional hazards model stratified by baseline prognostic category. For the comparison of OS between INC424 (INCB018424) and BAT, a stratified 2-sided log-rank test was used. Sensitivity analysis was also conducted for OS with the data being censored at the end of the Randomized Phase for those subjects who entered the Extension Phase. Unstratified analyses were also performed by reporting hazard ratios with 95% CIs.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary end)||2016-03-31|03/2016||||
1440099|NCT00934544|Secondary|Leukemia-free Survival (LFS)|Defined as the interval between randomization and the date of the bone marrow blast count of 20% or greater OR the date of the first peripheral blast count of 20% or greater that was subsequently confirmed to have been sustained for at least 8 weeks OR the date of death from any cause, whichever occurs first.LFS was summarized using Kaplan-Meier estimates for each treatment arm. The estimates were supplemented by tables of number of events and probability estimates at several timepoints.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary end)||2016-03-31|03/2016||||
1440100|NCT00934544|Secondary|Progression Free Survival (PFS) by Treatment|Defined as the time from the date of randomization/start of treatment to the date of the first documented disease progression including death due to any cause.|every three months after EOS until end of extension phase (96 weeks LPLV for the primary endpoint)||2016-03-31|03/2016||||
1440101|NCT00934544|Secondary|Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment|﻿This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume.|Baseline, every 12 weeks until first 35% reduction in spleen is achieved|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.|||Proportion of participants||95% Confidence Interval|Median
1440102|NCT00934544|Secondary|Duration of Maintenance of at Least 35% Reduction in Spleen Volume (DoMSR) From Baseline|DoMSR is defined as the interval between the first spleen volume measurement that is >=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a >25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.|Baseline, every 12 weeks until 25% progression from baseline|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. Treatment groups were defined according to the treatment assignment at the time of randomization.|||Proportion of participants||95% Confidence Interval|Median
1440103|NCT00934544|Secondary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24|The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.|Baseline, Week 24|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT)prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.|||Percentage of Participants|||Number
1440128|NCT00933686|Secondary|EuroQol 5-Dimensions (EQ-5D) Total Score|EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Units on a scale||Standard Deviation|Mean
1440104|NCT00934544|Primary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48|The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group.|Baseline, Week 48|Full analysis set (FAS) consisted of all subjects who were randomized and put in strata according to International Working Group for Myelofibrosis Research and Treatment(IWG MRT) prognostic criteria. The table included participants with non-missing baseline MRI measurement of spleen volume only.|||Percentage of Participants|||Number
1440105|NCT00934440|Secondary|Time to Progression|The time to progression was measured using time from the first day of treatment to the first day of an evaluation of progressive disease or the date of death for any cause.|2 years||||months||Full Range|Mean
1440106|NCT00934440|Primary|Toxicities by Dose Level|Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|3 to 6 months||||adverse events|||Number
1440107|NCT00934375|Primary|Number of Participants With Treatment-Emergent Adverse Events|Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)|Baseline, Week 6, Week 12 and Week 28.||||Participants|||Number
1440108|NCT00934362|Secondary|Spirometry|Percent change (relative) in FEV1 between pre-treatment baseline and following 5 doses of study treatment. Post treatment values obtained 3 and approximately 22 hours after 5th dose were averaged to determine the treatment effect.|after 5 doses|per protocol|||percent change||Standard Deviation|Mean
1440109|NCT00934362|Primary|Change in Mucociliary Clearance|Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. <60 minutes after the last dose of lucinactant or placebo) reported.|1 hour after final treatment (5th dose) minus baseline|Per protocol|||percent clearance||Standard Deviation|Mean
1440110|NCT00934180|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1440111|NCT00934180|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1440112|NCT00934180|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1440113|NCT00934141|Secondary|Cost of Group|"The goal of the economic analysis was to estimate costs of each group for governmental authorities who might organize improvement collaboratives. We collected the cost of personnel (state employees, NIATx employees, coaches and consultants), data management, buildings and facilities, lodging, travel, telephone calls and miscellaneous costs. Costs were categorized as group specific (such as hotel costs for the learning sessions group) or non-group-specific, which included state-incurred costs for outreach, data management and infrastructure, encouraging participation and administration. Cost data were collected three times during the study period and aggregated to create a total cost estimate. Figures reported below represent costs at the arm/group level (costs were not assessed at the organizational level). Measure type is Number."|Baseline and 18 months||||USD ($)|||Number
1440114|NCT00934141|Primary|Change in Average Continuation Rate Through the Fourth Treatment Session|"This outcome represents change in the rate at which a clinic's patients continue in treatment. Continuation rate is defined as the percentage of patients that make at least 4 visits to the clinic, on different days, before being discharged. Estimates of improvement show the average percentage points of improvement per month based on a best linear unbiased predictor estimate for each site.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 21 months||||Change in continuation rate||Standard Error|Mean
1440115|NCT00934141|Primary|Change in Annual Number of Patient Admissions|"We aimed to increase clinics' treatment capacity in this quality improvement study. Capacity was measured by counting clinics' annual number of patient admissions. We monitored changes in admission counts, per clinic, in a pre-post analysis. Changes in the natural logarithm of annual admissions are presented, which approximates the average percentage change (year-to-year) in the number of new patient admissions per clinic.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|48 months (2 year baseline period and 2 year post-intervention period)||||Percent change (approx.)||95% Confidence Interval|Mean
1440116|NCT00934141|Primary|Change in Average Waiting Time From First Contact to Treatment|"The average length of time in days it takes from when a patient first calls for help to the time a patient was able to meet a clinician. In this quality improvement study, changes in this measure over time are reported. Estimates of improvement show the average days of improvement per month based on a best linear unbiased predictor estimate for each site.~Note: this study has three primary outcomes. The number of participants analyzed varies for each outcome. The (higher) number of clinics shown in the flow diagram results because clinics may have been analyzed on a subset of the three primary outcomes (e.g., analyzed for waiting time and continuation, but not for annual number of new patients). To be considered analyzed in the flow diagram, a clinic must have been included in at least one primary outcomes analysis."|Baseline and 15 months||||Change in days||Standard Error|Mean
1440153|NCT00933543|Secondary|Percent Change From Baseline in Facial Non Inflammatory Lesion Count||12 weeks after first treatment|ITT|||percentage change from baseline||Standard Deviation|Mean
1440117|NCT00934128|Primary|Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale|Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.|Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)|One participant assigned to receive BiPAP was mistakenly started on Vapotherm (High Flow Oxygen = HFO), and was reported here in the HFO group.|||units on a scale||Inter-Quartile Range|Median
1440118|NCT00934128|Primary|Number of Participants Completing Study Intervention|"Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study.~A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was >/= baseline dyspnea level-1, or (2) their dyspnea level was >/= 3/10 after one hour."|Minimally 1 hour, up to 5 hours||||Participants|||Number
1440119|NCT00934102|Primary|Front Surface Lens Deposits|Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.|Period 2, Day 6|Per Protocol. Only the data from participants who completed all study visits were analyzed.|||Units on a Scale|Participants|Standard Deviation|Mean
1440120|NCT00934050|Primary|Treatment Emergent Adverse Events (TEAEs)|Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)|12 months|As a result of safety findings, effective 15 December 2009, all 50 patients at the 2000 mg BID dose were withdrawn from the study. Subsequently patients who were on placebo or 250 mg BID in Study AD201 received 250 mg BID in Study AD251. Only Arms who completed the study per the protocol were included in the analysis.|||participants|||Number
1440121|NCT00933933|Secondary|Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations|Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot.|||Blood specimens|||Number
1440122|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area.|||Blood specimens|||Number
1440123|NCT00933933|Primary|Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females.|||Blood specimens|||Number
1440124|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens|Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.|3 months|Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing.|||Blood specimens|||Number
1440125|NCT00933933|Primary|Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection|HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.|3 months|Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis.|||Blood Specimens|||Number
1440126|NCT00933686|Secondary|Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale|Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Percentage of participants|||Number
1440127|NCT00933686|Secondary|Multidimensional Assessment of Fatigue (MAF) Total Score|Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition.|Baseline, Month 6 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Units on a scale|||Number
1440129|NCT00933686|Secondary|Visual Analog Scale (VAS) Total Score|Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||mm||Standard Deviation|Mean
1440130|NCT00933686|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Total Score|Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful).|Baseline, Month 1, 3, 6, 7, 9 and 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure. 'n' signifies number of participants who were evaluable at each time-point for each arm group.|||Units on a scale||Standard Deviation|Mean
1440131|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 12|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 12|ITT population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1440132|NCT00933686|Primary|Percentage of Participants With Less Than 11 Tender Points at Month 6|The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.|Month 6|Intention-to-treat (ITT) population included all the participants who were randomized in the study. 'N' signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
1440133|NCT00933608|Primary|N-acetylaspartate|The change in N-acetylaspartate (NAA) measured with magnetic resonance spectroscopy (MRS) is the primary outcome measure. NAA is a metabolite found predominately in neuronal cells, and its amount indicates tissue well being (the higher the better). In MRS studies NAA (and other metabolites like choline or myoinositol) are presented as a ratio to creatine (Cr) also measured by MRS. The concentration of creatine does not change is used as an internal standard. The ratio NAA/Cr is unitless. In summary, the measurable outcome will be the NAA/Cr ratio change from pre-to post treatment.|baseline (pre-treatment) and 4 months (post-treatment)|This is an intention to treat analysis, based on initial treatment assignment.|||NAA/creatine Ratio||Standard Deviation|Mean
1440134|NCT00933543|Secondary|Proportion of Patients With Dryness (Mild)||at 12 weeks after first treatment|Safety|||participants|||Number
1440135|NCT00933543|Secondary|Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)||at 12 weeks after first treatment|Safety|||participants|||Number
1440136|NCT00933543|Secondary|Proportion of Patients With Severe and Very Severe Scarring at End of Study||week 12||||participants|||Number
1440137|NCT00933543|Secondary|Proportion of Patients With Clear or Almost Clear Scarring at End of Study||week 12||||participants|||Number
1440138|NCT00933543|Secondary|Proportion of Patients With Mild or Moderate Scarring at End of Study||week 12||||participants|||Number
1440139|NCT00933543|Secondary|Proportion of Patients With Severe Hyperpigmentation||at 12 weeks after first treatment|Safety|||participants|||Number
1440140|NCT00933543|Secondary|Proportion of Patients With Mild and Moderate Hyperpigmentation||at 12 weeks after first treatment|Safety|||participants|||Number
1440141|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after fourth treatment|Safety population|||cm||Full Range|Mean
1440142|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after third treatment|Safety population|||cm||Full Range|Mean
1440143|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after second treatment|Safety population|||cm||Full Range|Mean
1440144|NCT00933543|Secondary|Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable|Facial pain was assessed on a visual analogue scale ranging from 0-10cm.|directly after first treatment|Safety population|||cm||Full Range|Mean
1440145|NCT00933543|Secondary|Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.||6 weeks after the first treatment|ITT|||Participants|||Number
1440146|NCT00933543|Secondary|Absolute Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
1440147|NCT00933543|Secondary|Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count||6 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
1440148|NCT00933543|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Count||6 weeks after the first treatment|ITT|||lesions||Standard Deviation|Mean
1440149|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline||12 weeks after first treatment||||participants|||Number
1440150|NCT00933543|Secondary|Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count||12 weeks after last treatment|ITT|||participants|||Number
1440151|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||12 weeks after the first treatment|ITT|||Percent change from baseline||Standard Deviation|Mean
1440152|NCT00933543|Secondary|Percent Change From Baseline in Facial Total Lesion Count||6 weeks after the first treatment|ITT|||Percent change from baseline||Standard Deviation|Mean
1440164|NCT00933335|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from the treatment start date to the first occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with treatment failure were evaluated.|||months||95% Confidence Interval|Median
1440165|NCT00933335|Secondary|Number of Participants With a Treatment Failure|Treatment failure is defined as the occurrence of treatment withdrawal, a decision to seek additional therapy, study removal, progression, alternative therapy for lymphoma, or death.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440166|NCT00933335|Secondary|Time to Disease Progression or Death|Time to progression is the time from the treatment start date to the first documented disease progression or death. Disease progression: 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants with disease progression were evaluated.|||months||95% Confidence Interval|Median
1440167|NCT00933335|Secondary|Number of Participants With Progressive Disease (PD)|PD is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440168|NCT00933335|Secondary|Duration of Response for All Confirmed Responders|Duration of response was defined as the time from the first documented response to the first documented disease progression. Partial Response (PR): 50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions with no new lesions. Responders are the participants with CR, or CCR, or PR.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and were classified as responders were evaluated.|||months||95% Confidence Interval|Median
1440169|NCT00933335|Secondary|Number of Participants With Progression of Disease|Progression of disease is defined as a 50% increase from nadir of the sum of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >2 cm in diameter per radiographic evaluation or >1 cm in diameter by physical examination. All participants without progression of disease were censored.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: participants with confirmed response rates (CR, CCR, or PR) were evaluated.|||participants|||Number
1440170|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Unconfirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. Participants (par.) evaluable for response were those with >= 1 response assessment. 2 of 38 par. who received <3 cycles of fludarabine withdrew from the study and were not evaluable for response. 35 of 38 par. received TST and I 131 TST treatment and were evaluated for response.|||participants|||Number
1440171|NCT00933335|Secondary|Number of Participants With the Investigator-assessed Confirmed Responses of Complete Response (CR), Clinical Complete Response (CCR), and Partial Response (PR)|CR: Complete resolution of disease-related (DR) radiological abnormalities; disappearance of non-Hodgkin's lymphoma-related signs/symptoms. CCR: Complete resolution of DR symptoms except for residual scar tissue. PR: 50% reduction in the sum of the products of the longest perpendicular diameters of measurable lesions with no new lesions. A confirmed response (resp.) (CR/CCR/PR) had to be confirmed by a consecutive resp. (>=28 days later) that was the same/better. Individual confirmed resp. data only counts that resp. confirmed by the same resp.; not all possible combinations are represented.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population. 2 participants (par.) who received <3 cycles of fludarabine (fl.) did not receive TST treatment and were not evaluated. Par. evaluable for response were those with >=1 assessment. Three par. were not evaluable for response. None of the responses could be confirmed after fl. treatment; thus, no data are reported for this arm.|||participants|||Number
1440172|NCT00933335|Primary|Number of Participants Receiving the Indicated Type of Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease. Supportive care involved administration of granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), red blood cell (RBC) transfusions, erythropoietin, and platelet transfusions.|First day of fludarabine cycle 1 to day prior to TST/I 131 TST dosimetric dose (Week -16 to Week 1); Day of TST/I 131 TST dosimetric dose to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment and were not evaluated.|||participants|||Number
1440183|NCT00933335|Primary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.|||10^3/mm^3||Full Range|Median
1440173|NCT00933335|Primary|Number of Participants Who Received Any Supportive Care After Fludarabine Treatment and After TST Treatment|Supportive care involves interventions that help the participants to achieve comfort but do not affect the course of a disease.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: two participants who received less than 3 cycles of fludarabine did not receive TST treatment, and hence were not evaluated.|||participants|||Number
1440174|NCT00933335|Primary|Number of Participants With an Anti-infective Administered at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.|||participants|||Number
1440175|NCT00933335|Primary|Number of Participants With Positive Culture Results for Infections at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|The culture results could be positive or negative. The positive culture results indicates that the tested participant have the infection under investigation so therapeutic treatment with anti-infective is required.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses, those who had an infection, and from whom the cultures were obtained were evaluated.|||participants|||Number
1440176|NCT00933335|Primary|Number of Participants With a Culture Obtained for Infection at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated.|||participants|||Number
1440177|NCT00933335|Primary|Number of the Indicated Type of Infection Reported by Investigator Based on Laboratory Testing at Week 16 Post-Fludarabine (Fl) Treatment and Week 13 Post-TST Treatment|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses and those who had an infection were evaluated. A single participant could have had more than one infection. The number analyzed in the category titles reflects the number of participants who had any infection.|||number of infections|||Number
1440178|NCT00933335|Primary|Number of Participants With Any Infection at Week 16 Post-Fludarabine Treatment and Week 13 Post-TST Treatment Detected by Laboratory Culture of Participant Sample or Investigator Report|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Colloquially, infections are usually considered to be caused by microscopic organisms or microparasites like viruses, bacteria, and viroids, although larger organisms such as macroparasites and fungi can also infect.|Week 16 Post-Fludarabine Treatment (Week -16 to Week 0); Week 13 Post-TST Treatment (Week 1 to Week 13)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
1440179|NCT00933335|Primary|Duration of Any Grade 3 or Grade 4 Toxicity for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||days||Full Range|Median
1440180|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Toxicity (AE) for Hematological Parameters (Absolute Neutrophil Count [ANC], Hemoglobin, and Platelets)|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades (G): 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE. ANC (10^3/mm^3): G1=1.5 to <2.0, G2=1.0 to <1.5, G3=0.5 to < 1.0, G4=<0.5. Hemoglobin (g/dL): G1=10.0 to <12.0, G2=8.0 to <10.0, G3=6.5 to <8.0, G4=< 6.5. Platelets (10^3/microliter): G1=75 to <150, G2=50 to <75, G3=25 to <50, G4=<25.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
1440181|NCT00933335|Primary|Nadir Values for Platelet Count|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.|||10^3/microliter||Full Range|Median
1440182|NCT00933335|Primary|Nadir Values for Hemoglobin|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: only the 35 participants who received the dosimetric dose were evaluated.|||g/dL||Full Range|Median
1440184|NCT00933335|Primary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, and Platelets|Nadir was defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose).|up to 120 days following the therapeutic dose (or dosimetric dose for participants who did not receive the therapeutic dose)|ITT-Exposed Population: all participants who received the dosimetric dose were evaluated.|||days||Full Range|Median
1440185|NCT00933335|Primary|Number of Participants With Thyroid Medication Use Prior to the Therapeutic Dose|Thyroid medication included any prescribed medication for the treatment of thyroid dysfunction.|Baseline (study entry; Week -16) and Week 2 to Week 3 (prior to the therapeutic dose)|ITT-Exposed Population: all participants who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
1440186|NCT00933335|Primary|Number of Participants With Elevated Thyroid-Stimulating Hormone (TSH) Levels at Baseline (Study Entry) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|The number of participants with elevated TSH levels is reported. An elevated TSH level indicates that an insufficient amount of the thyroid hormone is being produced. Insufficient thyroid hormone production is known as hypothyroidism. The normal range of TSH is between 0.2 and 6.1 milliunits per liter (mU/L).|Baseline (Week -16) and Weeks 25, 52, 78, 104, 130, 156, 182, 208, 234, 260, 286, 312, 364, 416, 468, and 512|ITT-Exposed Population: baseline TSH levels were determined for 36 participants. Of 35 participants who received the dosimetric and therapeutic doses of TST/I-131 TST, 2 had elevated TSH at baseline, and 33 were assessed for developing elevated TSH.|||participants|||Number
1440187|NCT00933335|Primary|Time to HAMA Positivity From the First TST/I 131 TST Dosimetric Dose for the Participants Achieving HAMA Positivity|Kaplan-Meier estimates of the time to HAMA positivity (days from the first fludarabine dose) was determined for participants who converted to HAMA positivity.|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who received dosimetric and therapeutic doses and those who were converted to HAMA positivity were evaluated.|||days|||Number
1440188|NCT00933335|Primary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Weeks 12 and 25 and at Months 12, 18, and 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). Fludarabine, a known immunosuppressant, might decrease HAMA production in addition to reducing bone marrow involvement. To be positive, a participant had to have a positive HAMA assessment at any follow-up visit (Weeks 12 and 25; Months 12, 18, and 24)."|Day 1 to Day 730 (24 Months) after receiving the dosimetric dose|ITT-Exposed Population: participants who were evaluable for HAMA (those who did not have a positive HAHA level at Baseline) and those who received dosimetric and therapeutic doses were evaluated.|||participants|||Number
1440189|NCT00933335|Primary|Number of Participants With the Indicated Treatment-related AEs Experienced by at Least 10% of Participants in the Combined Regimen|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440190|NCT00933335|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 AEs|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. mm, millimeters; mm^3, millimeters cubed. Grade 3 and Grade 4 AEs are reported to focus on the most severe AEs.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440191|NCT00933335|Primary|Number of Participants With Any Treatment-related SAE|All of the treatment-related SAEs experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440192|NCT00933335|Primary|Number of Participants With Any Serious Adverse Event (SAE)|An SAE was defined as any event occurring at any dose that results in any of the following outcomes: death, a life threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440193|NCT00933335|Primary|Number of Participants With Any Treatment-related Grade 3 or Grade 4 Adverse Event|All of the treatment-related grade 3 (severe and undesirable) and grade 4 (life-threatening or disabling) adverse events experienced by the participants were recorded.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440194|NCT00933335|Primary|Number of Participants With Any Grade 3 or Grade 4 Adverse Event|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440423|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.|Quantitative Sensory Tests (QSTs), including, cold sensation threshold, cold pain threshold and vibration detection threshold, were used to evaluate peripheral sensory perception.|One year||||°C||Standard Error|Mean
1440195|NCT00933335|Primary|Number of Participants With Any Treatment-related Adverse Event (TRAE)|All noxious and unintended responses to a study treatment related to any dose were considered as TRAEs. A response to a study treatment indicates that a causal relationship between a study drug and an adverse event was at least a reasonable possibility, i.e., the relationship cannot be ruled out.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST DD (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|ITT-Exposed Population|||participants|||Number
1440196|NCT00933335|Primary|Number of Participants With Any Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a causal relationship (association) with this treatment. Therefore, an AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not it was considered to be related to the medicinal product. Laboratory abnormalities were recorded as AEs only if they were associated with clinical sequelae and/or required an intervention.|First day of fludarabine cycle 1 to day prior to TST and iodine I 131 TST dosimetric dose (DD) (Week -16 to Week 1); Day of TST and iodine I 131 TST DD to database release (Week 1 to Week 520)|Intent-to-Treat (ITT)-Exposed Population: all participants who were enrolled into the study and who received at least 1 dose of fludarabine. The data are presented for the subgroup of the ITT-Exposed Population for those participants who received the dosimetric and therapeutic dose of TST/I 131 TST.|||participants|||Number
1440197|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
1440198|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
1440199|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Time|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
1440200|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
1440201|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
1440202|NCT00933270|Secondary|Exercise Tolerance Test: Maximal Walking Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
1440203|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months (± 30 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
1440204|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
1440205|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Time (CPT)|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||seconds||Standard Deviation|Mean
1452612|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 12 (Month 24; 720 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1440206|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|12 months|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
1440207|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|1 month (± 7 Days)|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
1440208|NCT00933270|Secondary|Exercise Tolerance Test: Claudication Pain Distance|Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.|Baseline|Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.|||meters||Standard Deviation|Mean
1440209|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
1440210|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
1440211|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
1440212|NCT00933270|Secondary|Clinical Improvement Compared With Baseline: Rutherford Becker Scale|"Clinical Improvement Compared With Baseline~Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening"|1 month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.|||percentage of limbs|||Number
1440213|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|36 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
1440214|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|24 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
1440215|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|12 Months (± 30 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
1440228|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440216|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|1 Month (± 7 Days)|Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed|||percentage of limbs|||Number
1440217|NCT00933270|Secondary|Clinical Category: Rutherford Becker|"Category and Clinical Description~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.~Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction."|Baseline|Per ITT Set. Patients are included in the Rutherford Becker Score if the Rutherford Becker Classification was performed prior to the Study procedure.|||percentage of limbs|||Number
1440218|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440219|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440220|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440221|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440222|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440223|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440224|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440225|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440226|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440227|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440229|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440230|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440231|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440232|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440233|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440234|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440235|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440236|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440237|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440238|NCT00933270|Secondary|Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation|The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440239|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|12 Months (± 30 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit"|||units on a scale||Standard Deviation|Mean
1440250|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|30 days (±7 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
1440240|NCT00933270|Secondary|Quality of Life Assessed by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|6 Months (± 14 Days)|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit."|||units on a scale||Standard Deviation|Mean
1440241|NCT00933270|Secondary|Quality of Life Assessed (QoL) by SF-12 Questionnaire|The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.|Baseline|"Per ITT set.~Patients are included in the QoL endpoint if:~They completed the SF-12 Questionnaire prior to the study procedure"|||units on a scale||Standard Deviation|Mean
1440242|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|36 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440243|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|24 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440244|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|12 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440245|NCT00933270|Secondary|Index Limb Amputations|Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.|6 months (±14 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440246|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|36 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
1440247|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|24 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
1440248|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|12 months (±30 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
1440249|NCT00933270|Secondary|Major Adverse Events (MAVE)|"Defined as a composite rate of~stent thrombosis,~clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),~procedure-related arterial rupture,~acute limb ischemia,~target limb amputation,~procedure related bleeding event requiring transfusion."|6 Months (±14 days)|Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.|||percentage of participants|||Number
1440251|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|36 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
1440252|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|24 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
1440253|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|12 Months (±30 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
1440254|NCT00933270|Secondary|Limb Ischemia Improvement: Rutherford Becker Scale|"Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.~Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.~Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.~Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).~Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.~Grade -2 = Moderate worsening. Deterioration of the subject’s condition by one category or unexpected minor amputation.~Grade -3 = Marked worsening. Deterioration of the subject’s condition by more than one category or major amputation."|1 month (± 7 days)|"Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done."|||percentage of limbs|||Number
1440255|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.|36 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440256|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.|24 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440257|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.|12 months (±30 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440258|NCT00933270|Secondary|Target Vessel Revascularization|Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.|6 months (± 14 days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440270|NCT00933270|Secondary|Stent Fracture Rate|Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.|36 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab|||percentage of participants|||Number
1440259|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 Months (±30 days)|Per ITT set. Patients are included if they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
1440260|NCT00933270|Secondary|SFA Patency: PSV Ratio > 2.4|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
1440261|NCT00933270|Secondary|SFA Patency: PSV Ratio ≥ 2.0|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|6 Months (± 14 days)|Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit & sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed & analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
1440262|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|36 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440263|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|24 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440264|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|12 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440265|NCT00933270|Secondary|Target Lesion Revascularization (TLR)|Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.|6 months (± 14 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440266|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|12 Months (± 30 Days)|Per ITT set: Patient returned for visit and had ABI measured|||ratio||Standard Deviation|Mean
1440267|NCT00933270|Secondary|Ankle-brachial Index (ABI) on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|6 Months (± 14 Days)|Per ITT set: Patient returned for visit and had ABI measured|||ratio||Standard Deviation|Mean
1440268|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|1 month (± 7 Days)|Per ITT set: Patient returned for visit and had ABI measured|||ratio||Standard Deviation|Mean
1440269|NCT00933270|Secondary|Ankle-brachial Index (ABI) Measurements on Target Limb|A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.|Baseline|Per ITT set: Baseline ABI measured prior to study procedure|||ratio||Standard Deviation|Mean
1440272|NCT00933270|Secondary|Stent Fracture Rate|"Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.~Stent fracture classification~Type I - a single strut fracture only.~Type II - multiple single nitinol stent fractures that can occur at different sites.~Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.~Type IV - a complete transverse linear type III fracture with stent displacement.~Type V - a spiral dissection of a stent."|12 months (± 30 Days)|Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab|||percentage of participants|||Number
1440273|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||36 months (± 30 Days)||||percentage of participants||95% Confidence Interval|Number
1440274|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||24 months (± 30 Days)||||percentage of participants||95% Confidence Interval|Number
1440275|NCT00933270|Secondary|Long-Term Safety Endpoint (Clinically Driven TLR, Index Limb Amputation)||12 months (± 30 Days)||||percentage of participants||95% Confidence Interval|Number
1440276|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 36 months (± 30 Days)(comparing pre- to post-procedural assessments).|36 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440277|NCT00933270|Secondary|Secondary Safety Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).|24 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440278|NCT00933270|Secondary|Secondary Safety Composite Endpoint|Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).|12 months (± 30 Days)|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440279|NCT00933270|Secondary|Device Success|Device success, defined as achievement of a final residual diameter stenosis of <50% (by QA), using the assigned treatment only.|intraoperative|Per ITT set: Supera implanted. Post-procedure angiogram analyzed by core lab|||percentage of participants||95% Confidence Interval|Number
1440280|NCT00933270|Secondary|Procedural Success|Defined as device success with < 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.|intraoperative|Per ITT set. Supera implanted. Post-procedure angiogram analyzed by core lab Occurrence of death, amputation or TLR during the hospital stay|||percentage of participants||95% Confidence Interval|Number
1440281|NCT00933270|Secondary|Technical (Lesion) Success|Technical (lesion) success, defined as the attainment of <50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.|intraoperative|Per ITT set: Post-procedure angiogram analyzed by core lab|||percentage of treated segments||95% Confidence Interval|Number
1440282|NCT00933270|Primary|Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR ≥ 2.0) and TLR.|Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of > 2.0 when compared to the proximal normal segment.|12 months|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440283|NCT00933270|Primary|Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.||30 days|"Per ITT set.~Patients are included in the clinical endpoint if:~They return for their visit within the window~They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~The last contact date predated the endpoint time frame but had an event within the endpoint time frame."|||percentage of participants||95% Confidence Interval|Number
1440284|NCT00933244|Other Pre-specified|Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test|We summarized within-arm one-year changes in continuous muscle outcomes using the mean (95% confidence interval).|1 Year|4% of subjects withdrew from the study and muscle tests were not conducted in four additional subjects who sustained injury or reported leg pain during a study visit. Thus the number analyzed is less than the number randomized into the trial.|||seconds||95% Confidence Interval|Mean
1440285|NCT00933244|Other Pre-specified|Bone Turnover|C-telopeptide (pg/mL) was measured at baseline, 30 days, 60 days, 120 days, 365 days in the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am. Data demonstrated outliers and was summarized using the median (25th, 75th interquartile range).|0, 30, 60, 120, 365 days|Bone turnover markers were analyzed in duplicate for the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am.|||pg/mL||Inter-Quartile Range|Median
1452613|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 11 (Month 21; 630 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1440286|NCT00933244|Secondary|Bone Mineral Density|Annualized percent change in bone mineral density at spine, hip, femoral neck, and body|1 Year|Annual changes in bone mineral density were analyzed for subjects who completed the study. 9 subjects (4%) withdrew from the study, all for personal reasons. Thus, number of participants analyzed is 4% less than number of subjects randomized.|||Percent Change in Bone Mineral Density||Inter-Quartile Range|Mean
1440287|NCT00933244|Primary|Intestinal Calcium Absorption|Percent of calcium absorbed in the intestinal tract within one day|One Year|4% of subjects withdrew from the study. Additionally the calcium isotope dose was not recorded in 2 subjects and a urine sample was mishandled in a third. Thus, the number of participants analyzed is less than the number randomized into the trial.|||Total Fractional Calcium Absorption||Inter-Quartile Range|Median
1440288|NCT00933166|Primary|Comfort After Insertion|Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.|||Units on a Scale||Standard Deviation|Mean
1440289|NCT00932893|Secondary|European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1440290|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: 1 'Not at All' to 4 'Very Much'. Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms.|Baseline, Day 1 of each cycle until disease progression, end of treatment (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1440291|NCT00932893|Secondary|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score for Global Qol/functional scales=better level of QoL/functioning or higher score for symptom scale=greater degree of symptoms.|Baseline, Day (D) 1 of each cycle (C) until disease progression, end of treatment (EOT, up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants who were evaluable for specified time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1440292|NCT00932893|Secondary|Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough|TTD in pain (pain in chest from European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer [EORTC QLQ-LC13]), dyspnea (from EORTC QLQ-LC13), or cough (from EORTC QLQ-LC13) symptoms was defined as the time from randomization to the earliest time the participant's score showed a 10 point or higher increase from baseline in any of the three symptoms from the instrument. The transformed score of pain, dyspnea, and cough symptom scales of EORTC QLQ-LC13 range from 0 to 100, greater scores = higher symptom severity.|Baseline up to end of treatment (up to 112 weeks)|Patient Reported Outcome (PRO) evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline PRO assessment.|||months||95% Confidence Interval|Median
1440293|NCT00932893|Secondary|Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins|Descriptive statistics (absolute value and change from baseline as measured by ratio to baseline) for each best overall response category (CR, PR, SD, PD or combined) have been used to summarize the data from optional soluble c-Met ectodomain assays for crizotinib treated patients.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 2, end of treatment (up to 112 weeks)|The soluble biomarker-evaluable population includes patients from the SA population that received PF-02341066, who have an optional blood sample prior to dosing on Cycle 1 Day 1 and have at least 1 on-treatment soluble biomarker evaluation (Cycle 2 Day 1 and/or end of treatment).|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1440294|NCT00932893|Secondary|Number of Participants With Categorical Maximum QTcF for Crizotinib|QT interval corrected using Fridericia’s formula (QTcF): QT interval (time corresponding to the beginning of depolarization to re-polarization of the ventricles) divided by cube root of RR interval. Maximum QTcF was categorized as less than (<) 450 milliseconds (msec), 450 msec to <480 msec, 480 msec to <500 msec, and more than or equal to (>=) 500 msec. A participant is reported only once under the maximum QTcF interval observed at any of the time-points. Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Day 1 of Cycle 1, 2 to 6 hours post-dose on Day 1 of Cycle 1, 2|ECG-evaluable population included all randomized participants who received at least 1 dose of study treatment, and had a baseline and at least 1 post-baseline ECG measurement.|||participants|||Number
1452614|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 10 (Month 18; 540 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1440295|NCT00932893|Secondary|Plasma Concentration of Crizotinib|Only participants receiving crizotinib were to be analyzed for this outcome measure as per planned analysis.|Pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 5|"Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had 1 of the PK parameters of interest. Here N (number of participants analyzed) signifies participants evaluable for this measure. n=participants evaluable at specific time points."|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1440296|NCT00932893|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response. TTR was calculated for the subgroup of participants with objective tumor response. Objective tumor response was defined as CR or PR according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.|||weeks||Full Range|Median
1440297|NCT00932893|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.02. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment. Here 'N' (number of participant analyzed) signifies participants with objective tumor response.|||weeks||95% Confidence Interval|Median
1440298|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 12|Disease control: participants with CR, PR, or SD according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Week 12|FAS included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
1440299|NCT00932893|Secondary|Percentage of Participants With Disease Control at Week 6|Disease control: participants with CR, PR, or stable disease (SD) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 mm short axis). PR: at least 30 % decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Disease control is based on independent radiology review.|Week 6|FAS included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
1440300|NCT00932893|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis). PR: at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Objective response is based on independent radiology review.|Randomization until PD or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|FAS included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
1440301|NCT00932893|Secondary|Overall Survival Probability at Months 6 and 12|Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.|Month 6, 12|FAS included all participants who were randomized to study treatment.|||percent chance of survival||95% Confidence Interval|Number
1440302|NCT00932893|Secondary|Overall Survival (OS)|OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.|Randomization until death (up to 4.5 years)|FAS included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
1440303|NCT00932893|Primary|Progression-Free Survival (PFS)|PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)|Full analysis set (FAS) included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
1440304|NCT00932828|Secondary|Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT.|In addition to studying the effectiveness of peanut OIT, we will also determine the safety of peanut OIT by reporting the average rate of TAEs per person per dose.|After 36 months of OIT dosing followed by 1 month of avoidance|37 subjects considered with ITT analysis including 5 withdrawals|||AEs per person per dose||95% Confidence Interval|Median
1440305|NCT00932828|Secondary|Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).|We expect to demonstrate the effectiveness of peanut OIT in inducing desensitization by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT .|After 36 months of OIT dosing|37 subjects considered with ITT analysis including 5 withdrawals|||Participants|||Count of Participants
1440306|NCT00932828|Primary|Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).|The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks.|After 36 months of OIT dosing followed by 1 month of avoidance|37 subjects considered with ITT analysis including 5 withdrawals|||Participants|||Count of Participants
1440307|NCT00932659|Secondary|Number of Participants Experiencing a Peridialytic or Intradialytic Arrhythmias||6 months|all participants included|||participants|||Number
1440308|NCT00932659|Primary|Number of Participants With a Significant Arrhythmia Detected||6 months|All patients enrolled were analyzed in this observational study.|||participants|||Number
1440309|NCT00932646|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks||||participants|||Number
1440310|NCT00932646|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS).|||Liter||Standard Error|Least Squares Mean
1440311|NCT00932646|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440312|NCT00932646|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Peak FVC was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440313|NCT00932646|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
1440314|NCT00932646|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
1440315|NCT00932646|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
1440316|NCT00932646|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440886|NCT00928408|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density (g/cm^2). Anatomic Site: Femoral Neck; Densitometer: Hologic|Results only shown where >10 patients have data|Baseline to Month 12|Full Analysis Set - Participants with Observed Data|||Percent change||Inter-Quartile Range|Median
1440317|NCT00932646|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Peak values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440318|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
1440319|NCT00932646|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of the treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
1440320|NCT00932646|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) date and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.|||Liter||Standard Error|Least Squares Mean
1440321|NCT00932620|Secondary|Changes in Low-density Lipoprotein Cholesterol (LDL-C)||3 months||||LDL-C, mg/dL||Standard Deviation|Mean
1440322|NCT00932620|Primary|Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels||Baseline and 3 months||||sdLDL-C, mg/dL||Standard Deviation|Mean
1440323|NCT00932477|Secondary|The Number of Ophthalmic Adverse Events at 1 Week|The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Number of adverse events|||Number
1440324|NCT00932477|Secondary|Best-Corrected Visual Acuity (BCVA) Status at 1 Week|"BCVA status at 1 week reported as the number of patients whose scores were either Better, No Change, or Worse than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. Better equals increase of 2 lines or more in at least 1 eye; No Change equals change between -2 to +2 lines in either eye; Worse equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly."|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Number of Patients|||Number
1440325|NCT00932477|Secondary|Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week|Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Number of Patients|||Number
1440326|NCT00932477|Primary|Tolerability Questionnaire Mean Scores at 1 Week|Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.|1 Week|Safety population, which consisted of all patients who started the study (randomized) and received treatment.|||Scores on a scale||Standard Deviation|Mean
1440327|NCT00932451|Primary|Percentage of Participants With Adverse Events|Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).|||Percentage of Participants|||Number
1440328|NCT00932451|Primary|Objective Response Rate|The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Percentage of participants||95% Confidence Interval|Number
1440384|NCT00932126|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
1440329|NCT00932451|Secondary|Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale|The EQ-5D descriptive system measured a patient’s health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent’s self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1440330|NCT00932451|Secondary|Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)|"The participants who responded to the question: Have you experienced any visual disturbances? Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question."|6 years|The safety analysis population included all participants who were enrolled and received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing).|||Percentage of participants|||Number
1440331|NCT00932451|Secondary|Mean Change From Baseline of QLQ-LC13 Scale Scores|The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1440332|NCT00932451|Secondary|Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores|The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The PRO evaluable population was defined as the participants from the SA population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1440333|NCT00932451|Secondary|Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.|The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher (“worse”) symptom severity, higher (“better”) functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.|6 years|The patient reported outcomes (PRO) evaluable population was defined as the participants from the safety analysis (SA) population who completed a baseline assessment and at least one post-baseline assessment.|||Units on a scale||Standard Deviation|Mean
1440334|NCT00932451|Secondary|QTc Prolongation in Participants|The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and ≥500 msec) were evaluated.|6 years|Participants from the SA population who had a Baseline (last ECG [electrocardiogram] prior to Cycle 1 Day 1 dose) and ≥1 post Baseline ECG measurement and were not included in the ECG sub-study.|||Percentage of participants|||Number
1440335|NCT00932451|Secondary|Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)|The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.|6 years|The All Genotyped Population was defined as all participants in the safety analysis population who had at least 1 genotype result. The Pharmacogenomic Evaluable (PE) Population was defined as participants in the All Genotyped Population who had an HLA genotype result and were designated as an ALT Case or Control.|||Percentage of participants|||Number
1440350|NCT00932373|Primary|PK Parameters After the First Dose: Terminal Half-life (t½) for T-DM1 Concentrations|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.|||day||Standard Deviation|Mean
1440887|NCT00928408|Primary|Change From Baseline to Month 12 in Albumin-corrected Serum Calcium||Baseline to Month 12|Full Analysis Set - Participants with Observed Data|||mmol/L||Standard Error|Mean
1440336|NCT00932451|Secondary|Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)|Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.|6 years|The safety analysis population included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing) and were ALK positive by IUO (SA-ALK positive by IUO population)|||Percentage of cells||Full Range|Median
1440337|NCT00932451|Secondary|Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182|Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.|6 years|All participants who have ≥ 1 measurement of PF-02341066 or PF-06260182 at the time of reporting are included in PK analysis. Concentration at Cycle 2 Day 1 and beyond are considered steady state, and only included those who received at least 14 continuous days of 250 mg BID dosing.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1440338|NCT00932451|Secondary|Probability of Survival|Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.|||Percentage of probability||95% Confidence Interval|Number
1440339|NCT00932451|Secondary|Overall Survival (OS)|OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death − date of Cycle 1 Day 1 dose + 1)/30.4.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.|||Months||95% Confidence Interval|Median
1440340|NCT00932451|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.|6 years|The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic [PK] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively.|||Months||95% Confidence Interval|Median
1440341|NCT00932451|Secondary|Disease Control Rate (DCR)|DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Percentage of participants||95% Confidence Interval|Number
1440342|NCT00932451|Secondary|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Weeks||Full Range|Median
1440343|NCT00932451|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death − first date of CR or PR that was subsequently confirmed + 1)/30.4.|6 years|Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment.|||Months||95% Confidence Interval|Median
1440344|NCT00932425|Primary|Completion of Assigned Monitoring as a Measure of Feasibility|Feasibility criteria included more than 70% completion of cardiac monitoring if applicable. Patients in the Monitoring arm were assigned to wear a Cardionet mobile cardiac outpatient telemetry monitor for 21 days. Outpatient monitoring began 22 days (+/- 12 days) after symptom onset.|21 days|Only patients in the monitoring arm were assessed for compliance with assigned monitoring|||participants|||Number
1440345|NCT00932425|Secondary|Recurrent Stroke or TIA|Patients and their primary physicians or neurologists were contacted at 3 months and 1 year after discharge and reported clinical diagnoses of recurrent stroke or TIA using validated questionnaires. Reported events were verified by review of relevant medical records.|1 year||||participants|||Number
1440346|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||1 year|2 participants in the Control arm were followed for less than 90 days|||participants|||Number
1440347|NCT00932425|Secondary|Diagnosis of Atrial Fibrillation||90 days|2 patients in the control arm did not have a full 90 days of assessment (see Participant Flow)|||participants|||Number
1440348|NCT00932425|Primary|Completion of Clinical Follow-up as a Measure of Feasibility|Feasibility was defined as 90% or more of randomized patients completing full clinical follow-up and 70% or more completion of assigned cardiac monitoring if applicable|1 year||||participants|||Number
1440349|NCT00932399|Primary|% Weight Change From Baseline|Time window for 3 years is 31-39 months after baseline|At ~3 years after baseline||||% weight change||95% Confidence Interval|Mean
1440351|NCT00932373|Primary|PK Parameters After the First Dose: Area Under the Plasma Concentration-time Curve From 0 to Infinity (AUC[0-∞] for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.|||day • μg/mL||Standard Deviation|Mean
1440352|NCT00932373|Primary|Pharmacokinetic (PK) Parameters After the First Dose: Maximum Observed Plasma Concentration Cmax for T-DM1 Concentrations||3-Week and Weekly Cohorts: Cycle 1 Day 1 Pre-dose 30 minutes and 4 hours after the end of infusion; Cycle 1 Day 2, 3, 4, 8 (Pre-dose 30 minutes after the end of infusion) 11, 15 (Pre-dose 30 minutes after the end of infusion) and 18|Pharmacokinetic-evaluable patients were defined as patients who received at least one dose of T-DM1 with at least one post-dose concentration data point.|||μg/mL||Standard Deviation|Mean
1440353|NCT00932373|Primary|Maximum Tolerated Dose (MTD)|The highest dose level resulting in a DLT in ≤ 1 of 6 patients was declared the MTD.|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1|||mg/kg|||Number
1440354|NCT00932373|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|"DLT is defined as one of the following as per investigator related to study drug:~Grade ≥ 3 non-hematologic, non-hepatic major organ toxicity~Grade ≥ 3 cardiac toxicity, including cardiac troponin I elevation or any new segmental wall abnormality as determined by non-invasive cardiac imaging~Grade ≥ 4 thrombocytopenia~Grade ≥ 4 neutropenia (absolute neutrophil count < 500/μ L) lasting > 4 days or accompanied by fever~Grade ≥ 4 anemia~Grade ≥ 3 serum bilirubin, hepatic transaminase (alanine aminotransferase or aspartate aminotransferase), or alkaline phosphatase For patients with Grade 2 hepatic transaminase or alkaline phosphatase levels at baseline as a result of liver metastases or bone metastases, a hepatic transaminase or alkaline phosphatase level ≥ 10 times the upper limit of normal will be considered a DLT.~Weekly cohorts only: Toxicity preventing retreatment on Cycle 1, Day 8 or toxicity preventing re-treatment on Cycle 1, Days 15 and Day 22"|A minimum of 21 days after first dose of trastuzumab-MCC-DM1|Safety Population included all treated patients|||participants|||Number
1440355|NCT00932373|Secondary|Percentage of Participants With Anti-therapeutic Antibodies to Trastuzumab Emtansine|After the start of trastuzumab emtansine treatment, serum samples were collected every 3 weeks prior to trastuzumab emtansine dosing for detection of anti-therapeutic antibodies using a validated assay. A bridging antibody electrochemiluminescence assay (ECLA) was used to detect antibodies to trastuzumab emtansine. The assay utilized trastuzumab emtansine conjugated to biotin and a ruthenium label to form a complex with anti-trastuzumab emtansine antibodies. The antibody complex was captured by streptavidin-coated paramagnetic beads.|Baseline to the end of the study (up to 3 years 2 months)||||percentage of participants|||Number
1440356|NCT00932373|Secondary|Progression-free Survival|Progression-free survival was defined as the time from first dose of trastuzumab emtansine to documented disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.|||Months||95% Confidence Interval|Median
1440357|NCT00932373|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from the initial response to disease progression or death from any cause within 30 days of the last dose of trastuzumab emtansine.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.|||Months||95% Confidence Interval|Median
1440358|NCT00932373|Secondary|Percentage of Participants With an Objective Response|The occurrence of an objective response was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). An objective response was defined as a complete response or a partial response as determined on 2 consecutive occasions ≥ 4 weeks apart. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 3 years 2 months)|Efficacy population: All enrolled participants who received treatment.|||percentage of participants|||Number
1440359|NCT00932373|Primary|Percentage of Participants With Adverse Events (AE), Serious Adverse Events (SAE), AEs With Grade >=3, and AEs Related To Treatment|"The time frame for AEs is study treatment initiation until 30 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first.~The time frame for SAEs is study treatment initiation until 90 days after last administration of study treatment or at the time of initiation of another anti-cancer therapy, which ever occurs first."|Study treatment initiation until 30 or 90 days after last administration of study treatment|Safety-evaluable population: All participants who received at least 1 dose of trastuzumab-MCC-DM1|||percentage of participants|||Number
1440360|NCT00932321|Secondary|Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population|Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.|5.6 months (6 - 28 day cycles)|Modified Intent to Treat (MITT)|||Days||Standard Deviation|Mean
1440361|NCT00932321|Primary|Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population|Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment|5.6 months (6 - 28 day cycles)|Modified intention to treat (MITT) subset of all treat subjects - evaluated for pregnancy at least once after beginning study medication.|||Pearl Index|||Number
1440362|NCT00932282|Secondary|Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy|The primary safety outcome of the study is to determine the frequency of side effects during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of allergic symptoms that occur during oral immunotherapy when compared to previously published results|approximately 24 or 36 months||||side effects reported per 100 OIT doses|||Number
1440363|NCT00932282|Secondary|Incidence of All Serious Adverse Events During the Study|A secondary safety outcome of the study is to determine the frequency of SAEs during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of SAEs that occur during oral immunotherapy when compared to previously published results|approximately 24 or 36 months||||SAEs per 100 OIT doses taken|||Number
1440364|NCT00932282|Secondary|The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study|A secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical desensitization as measured by passing an oral food challenge to 20 grams of peanut flour on the final day of peanut OIT dosing.|approximately 24 or 36 months||||Participants|||Count of Participants
1440365|NCT00932282|Secondary|The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour.|A secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to a peanut oral immunotherapy protocol allows for a higher amount of peanut tolerated after the rush desensitization phase, thereby reducing the duration of buildup phase and achieving maintenance dosing more rapidly|4 months||||Participants|||Count of Participants
1440366|NCT00932282|Primary|The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy|The primary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical tolerance as measured by passing an oral food challenge to 20 grams of peanut flour, 2-4 weeks after discontinuing peanut OIT therapy|approximately 24 or 36 months||||Participants|||Count of Participants
1440367|NCT00932165|Primary|Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status||24 weeks|The participants who were evaluated for efficacy of Aromasin for the post-operative adjuvant therapy.|||participants|||Number
1440368|NCT00932165|Primary|Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment|Anti-tumor effect was evaluated according to the rules for ‘General Rules for Clinical and Pathological Recording of Breast Cancer’ (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start.|24 weeks|N = number of participants with tumor response|||participants|||Number
1440369|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction|The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.|24 weeks|Subjects with renal Dysfunction.|||participants|||Number
1440370|NCT00932165|Primary|Number of Participants With Adverse Drug Reaction|Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported.|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.|||participants|||Number
1440371|NCT00932165|Primary|Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Scale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, <50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, >50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)|24 weeks||||participants|||Number
1440372|NCT00932165|Secondary|Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction|The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information.|24 weeks|Subjects with hepatic Dysfunction.|||participants|||Number
1440373|NCT00932165|Primary|Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane|Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.|||participants|||Number
1440374|NCT00932165|Secondary|Number of Participants With Unexpected Adverse Drug Reaction|"Adverse drug reaction that is not included in the “precautions for use”or undesirable effects section in the package insert (same as Local Product Document)."|24 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.|||participants|||Number
1440375|NCT00932152|Secondary|To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
1440376|NCT00932152|Secondary|To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
1440377|NCT00932152|Secondary|To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities||1.5 years|No data displayed because Outcome Measure has zero total participants analyzed.||||||
1440378|NCT00932152|Primary|To Evaluate the Progression-free Survival.||1.5 years|Analysis was not completed because the trial was stopped prematurely due to slow accrual.||||||
1440379|NCT00932126|Secondary|Baseline Tumor Expression of PAK-related Pathway Molecules and Other Known Biomarkers||Baseline|Data not analyzed due to early study termination.||||||
1440380|NCT00932126|Secondary|PAK (p21 Activated Kinase)-Related Pathway Molecule Expression Modulation by PF-03758309 in Tumor and Surrogate Tissue||Screening, 0, 2, 4, and 72 hours post dose Cycle 2 Day 8. A 6th sample of hair follicle could be requested at 6 or 8 hours post-dose if necessary. For fresh tumor tissue, baseline and between Day 8 and 22 of Cycle 1 in participants with accessible tumors|Data not analyzed due to early study termination.||||||
1440381|NCT00932126|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
1452615|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 09 (Month 15; 450 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1440386|NCT00932126|Secondary|Maximum Observed Plasma Concentration (Cmax)||predose, 0.5, 1, 2, 3, 5, 8, 10, 24 and 48 hours post dose, on Cycle 1 Day 8 and Cycle 2-4 Day 1 at pre-dose and 2 hours post morning dose, and on Cycle 1 Day 15 at predose, 0.5, 1, 2, 3, 5, 8 and 10 hours post morning dose|Data not analyzed due to early termination of the study.||||||
1440387|NCT00932126|Secondary|Duration of Response|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.||||||
1440388|NCT00932126|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Data not analyzed due to early termination of the study.||||||
1440389|NCT00932126|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 2 months until when the last participant was discontinued due to disease progression in Month 27 of the study|Per protocol analysis set: all participants who have received a minimum of 1 cycle of study treatment (at least 80% of planned dose), had baseline assessments and at least 1 on-study tumor assessment were considered evaluable for response.|||participants|||Number
1440390|NCT00932126|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLT)|DLT includes: Grade (GR) 4 neutropenia (NP) that persisted for >7 consecutive days; Febrile NP; GR3 NP infection; GR4 thrombocytopenia (TP); GR3 TP with bleeding; Any other GR>=3 toxicity not classified under Common Terminology Criteria for Adverse Events (CTCAE) blood or bone marrow (exception of nausea, vomiting, or diarrhea in subjects who received optimal treatment with antiemetics or anti-diarrheals); Failure to recover to an adequate condition to recommence study treatment after a 2-week delay; Failure to receive >= 80% of planned PF-03758309 dose due to study drug related toxicity|Baseline (up to 30 days prior to first study drug administration) till 28 days after the last treatment administration (end of Cycle 1 [28 days])|Safety analysis set: All participants enrolled in the study that received at least 1 dose of PF-03758309 (including the lead in dose).|||participants|||Number
1440391|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Photography Completed||Week 0 and Week 16||||participants|||Number
1440392|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Target Lesion Score|The lesion score of a single psoriatic plaque selected at baseline. Total range is 0 - 12 with 0 being clear and 12 representing the most severe disease. The target lesion score is composed of scale, erythema, and induration, each parameter is scored 0 (clear) through 4 (very severe). Totals are summed for target lesion score. S+E+I = TLS|Week 0 and Week 16||||units on a scale||Full Range|Mean
1440393|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: % Body Surface Area||Week 0 and week 16||||percentage of total body surface area||Full Range|Mean
1440394|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: Physician's Global Assessment (PGA) Clear or Almost Clear (PGA 0-1)||Week 0 and Week 16||||percentage of subjects|||Number
1440395|NCT00932113|Other Pre-specified|Additional Gene Analysis (Ongoing)|A single, long-term follow-up visit will be done for all available subjects for additional pharmacogenetic analysis. The goal in collecting DNA from psoriasis patients is to determine if individual subjects have gene variants associated with increased incidence of psoriasis. The investigators plan on analyzing variants using single nucleotide polymorphism (SNP) analysis by high-throughput DNA sequencing. This patient genetic information may allow us to correctly interpret data collected about gene expression levels in affected or non-affected skin. Additionally genetic typing may lead to cogent personalized health care (PHC) strategies for the identification of psoriasis drug responders/non-responders, patients who achieve durable disease remission post-treatment, and/or pharmacodynamic markers, as examples.|long-term follow-up visit 4- 6 years post end of study|||||||
1440396|NCT00932113|Secondary|Clinical Endpoints for Psoriasis: PASI 75|PASI 75 is the percent of subjects who experience an improvement in PASI (Psoriasis Area and Severity Index) score of at least 75% from their baseline PASI score.|Weeks 0 and week 16||||percentage of subjects|||Number
1440397|NCT00932113|Primary|Biologic Activity Endpoints|Histologic and Immunohistochemistry endpoints; Relative messenger RNA gene expression (normalized to HARP); and Gene Arrays.|Weeks 0, 1, 2, 4 and 16||||fold change||Standard Error|Mean
1440398|NCT00932035|Primary|Percentage of Patients With Lymphedema|Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.|||Participants|||Count of Participants
1440399|NCT00932035|Primary|Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes|A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.|||Participants|||Count of Participants
1440888|NCT00928408|Primary|Change From Baseline to Month 6 in Albumin-corrected Serum Calcium||Baseline to Month 6|Full Analysis Set - Participants with Observed Data|||mmol/L||Standard Error|Mean
1440400|NCT00932035|Primary|Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein|A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group.|Up to 4 years|Because of early termination the study did not accrue the planned number of subjects.|||Participants|||Count of Participants
1440401|NCT00932022|Secondary|Percent Change From Baseline in Percentage of Patients Continent|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
1440402|NCT00932022|Secondary|Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
1440403|NCT00932022|Secondary|Percent Change From Baseline in Voided Volume|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
1440404|NCT00932022|Secondary|Percent Change From Baseline in Urgency Severity Associated With Toilet Voids|Due to lack of evaluable data, analysis for this outcome measure was not performed.|Baseline (Week 2), Week 14|||||||
1440405|NCT00932022|Primary|Percent Change From Baseline in Urinary Urgency Incontinence (UUI)|Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.|Baseline (Week 2), Week 14|Modified Intent-to-Treat (mITT) defined as all patients who were randomized and received at least one dose of study medication. Analysis below was done on patients from the mITT population who completed the study at Week 14 and who had data available for this outcome measure.|||Percent change||Standard Deviation|Mean
1440406|NCT00931996|Primary|Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline.|Positive and Negative Syndrome Scale (PANSS) Total Score. 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. PANSS Total score minimum = 30, maximum = 210 Higher scores represent more severe symptoms. A positive change score (baseline-6 weeks) indicates an improvement in symptoms.|Baseline and 6 weeks|Completers|||units on a scale||Standard Deviation|Mean
1440407|NCT00931918|Secondary|Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher|Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE.|Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment)|Safety Population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1440408|NCT00931918|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category|Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)|Safety Population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1440409|NCT00931918|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||months||95% Confidence Interval|Median
1440410|NCT00931918|Secondary|Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate|FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point.|End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1440424|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.|Quantitative Autonomic Function Tests (QAFTs) were performed. Primarily, power spectral analysis of heart rate variability (HRV) and time- and frequency-domain analyses, including measures of the sympathetic and parasympathetic control of the heart beat (R-R interval), were recorded with deep breathing, Valsalva, and standing from the sitting position maneuvers. Additionally, the sample difference of the beat to beat (NN) intervals and the TSP was calculated as well as the standard deviation of all normal R-R intervals (sdNN).|One year||||ms||Standard Error|Mean
1440411|NCT00931918|Secondary|Duration of Response|Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Participants from the Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment who had a CR or PR|||months||95% Confidence Interval|Median
1440412|NCT00931918|Secondary|Complete Response Rate|Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1440413|NCT00931918|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites.|End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]|Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
1440414|NCT00931918|Secondary|Overall Survival|Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||months||95% Confidence Interval|Median
1440415|NCT00931918|Primary|Progression-Free Survival Rate|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.|2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||percentage of participants|||Number
1440416|NCT00931918|Primary|Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)|PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir.|Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm|Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype.|||months||95% Confidence Interval|Median
1440417|NCT00931879|Primary|Efficacy Measures Examining Increased Vascular Response to Ischemic Block and to Local Warming at the Dorsum of the Foot.||One Year|Measures of vascular response to ischemic block and local warming at the dorsum of the foot were not reliably collected for this assessment due to the difficulty of analysis and the inability to properly distinguish a vascular response in patients.||||||
1440418|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction||One Year||||m/s||Standard Error|Mean
1440419|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency.||One Year||||ms||Standard Error|Mean
1440420|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity.||One Year||||m/s||Standard Error|Mean
1440421|NCT00931879|Primary|Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress.|Oxidative stress/inflammatory markers (IL1β, IKKβ, TLR4, TNF-α, JNK1, toll-like receptor 2) were assessed through a meal challenge.|One year||||pg/ml||Standard Error|Mean
1440422|NCT00931879|Primary|Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds|Quantitative Sensory Tests (QSTs), including vibration detection threshold, were used to evaluate peripheral sensory perception. Mean represents percent change of total group. Measurements taken at baseline and at one year.|One year||||% Change||Standard Error|Mean
1440425|NCT00931879|Primary|Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.|19 participants in each arm( placebo or omega-3-ethyl esters 4g) were analyzed . Conduction velocities and amplitude of the following nerves were compared between each arm: Tibial Nerve Ankle Amplitude, Tibial Nerve Popliteal Amplitude, Median Nerve Wrist Amplitude, Median Nerve Elbow Amplitude, Peroneal Motor Nerve Ankle Amplitude, Peroneal Motor Nerve Below Fibular Amplitude, Peroneal Motor Nerve Above Fibular Amplitude, Sensory Median Nerve Wrist Amplitude, Sensory Ulnar, Sensory Sural Ankle Ampltiude Wrist Ampltiude|One year||||uV||Standard Error|Mean
1440426|NCT00931801|Secondary|Change in Quality of Life From Baseline to 48 Weeks of Study Treatment|Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.|baseline and 48 weeks|Data for all participants assigned to a study treatment was analyzed except data for participants that did not have both baseline and week 48 data, including early withdrawal, virologic failure, loss to follow-up or missing data.|||units on a scale||Standard Deviation|Mean
1440427|NCT00931801|Secondary|The Change in Adherence to Study Treatment Arm From Baseline to Week 48|Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or other error.|||percentage of prescribed doses||Standard Deviation|Mean
1440428|NCT00931801|Secondary|The Difference in CD4 From Baseline to Week 48|Change in mean CD4 from Baseline to Week 48.|Baseline and Week 48|Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or lab error.|||cells/mm3||Standard Deviation|Mean
1440429|NCT00931801|Primary|Maintenance of Virologic Suppression|To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.|48 weeks|All enrolled participants were included in this analysis of primary outcome measurement.|||participants|||Number
1440430|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 11|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 11 (insight) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440431|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 10|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 10 (appearance) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440432|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 9|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. . This analysis is for Item 9 (disruptive-aggressive behavior) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440433|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 8|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 8 (content) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440434|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 7|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 7 (language-thought disorder) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440457|NCT00931632|Secondary|Severity of Bronchopulmonary Dysplasia|Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.|36 weeks|Number of subjects within the Intent-to-treat population with available data|||Participants|||Count of Participants
1440458|NCT00931632|Secondary|Number of Days of Oxygen Use||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Number of subjects within the Intent-to-treat population with available data|||Days||Standard Deviation|Mean
1440435|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 6|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 6 (speech-rate and amount) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440436|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 5|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 5 (Irritability) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440437|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 4|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43||||Scores on a scale||Standard Error|Least Squares Mean
1440438|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 3|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 3 (sexual interest) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440439|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 2|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 2 (increased motor activity-energy) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440440|NCT00931723|Secondary|Change From Baseline to Day 43 in Each YMRS Item Score No. 1|The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 1 (Elevated mood) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440441|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Positive Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440442|NCT00931723|Secondary|Change From Baseline to Day 43 in PANSS Activation Subscale Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440443|NCT00931723|Secondary|Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210.A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440444|NCT00931723|Secondary|Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms.|Change from baseline to Day 43.||||Scores on a scale||Standard Error|Least Squares Mean
1440445|NCT00931723|Secondary|Improvement of Overall Bipolar Illness|"The number of patients with a CGI-BP-C of “Much” or “Very much” improved in overall bipolar illness assessment at Day 43 was calculated.~The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement."|Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Participants|||Number
1440446|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)|The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from baseline to Day 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440447|NCT00931723|Secondary|Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)|The CGI-BP-S scale rates the severity of the patient’s illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440448|NCT00931723|Secondary|Remission|"The number of patients with clinically significant remission (defined as YMRS total score ≤12) from Days 8 to 43) was calculated.~The Young Mania Rating Scale total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|Days 8 to 43|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Participants|||Number
1440449|NCT00931723|Secondary|The Number of Patients With Clinically Significant Response.|The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.|43 days (from baseline to Day 43)|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Participants|||Number
1440450|NCT00931723|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)|The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).|Change in YMRS total score from baseline to Day 43.|173/176 is modified intent to treat analysis set. The reason why is different from 173/183 is that there is 7 patients excluded from the analysis (1 patient who did not take study drug and 6 patients who did not have post treatment YMRS scores).|||Scores on a scale||Standard Error|Least Squares Mean
1440451|NCT00931710|Secondary|Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit|To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.|3, 6, 9 and 12 weeks|Full Analysis Set (FAS).|||cumulative percentage of patients|||Number
1440452|NCT00931710|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks|To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to week 12|Full Analysis Set (FAS). Last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
1440453|NCT00931710|Secondary|Cumulative Percentage of Treatment Responders|To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).|||Cumulative percentage of responders|||Number
1440454|NCT00931710|Secondary|Cumulative Percentage of Patients Achieving Blood Pressure Control|To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|3 and 6 weeks|Full Analysis Set (FAS).|||cumulative percentage of patients|||Number
1440455|NCT00931710|Secondary|Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
1440456|NCT00931710|Primary|Change in Mean Sitting Systolic Blood Pressure After 6 Weeks|To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.|Baseline to Week 6|Full Analysis Set (FAS). Last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
1440459|NCT00931632|Secondary|Systemic Use of Postnatal Corticosteroids for Any Medical Reason||Through hospital discharge, an average of 105 days for placebo and 108 days for INO|Intent-to-treat population|||Participants|||Count of Participants
1440463|NCT00931632|Secondary|Days of Airway Pressure Support - Intent-to-treat Population|Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.|Through hospital discharge, an average of 105 days for placebo and 108 days for INO||||Days||Standard Deviation|Mean
1440464|NCT00931632|Primary|Survival Without BPD at 36 Weeks||Baseline, 36 weeks PMA|Subjects with missing primary outcome or who crossed over to open-label iNO during the blinded treatment period were considered as failures|||participants|||Number
1440465|NCT00931528|Other Pre-specified|Patient Follow-up Treatment for Erectile Dysfunction at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline, week 30 and years 1 and 2 after the start of treatment|||||||
1440466|NCT00931528|Other Pre-specified|Radiotherapy Factors Associated With Spontaneous (Off-drug) EF at Weeks 28-30 and Years 1 and 2 After Initiation of RT||Baseline, week 30 and years 1 and 2 after the start of treatment|||||||
1440467|NCT00931528|Secondary|Partner Marital Adjustment as Measured by the Locke's Marital Adjustment Test|The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.|Baseline, week 30 and years 1 and 2 after the start of treatment|Consenting spouses of randomized, eligible patients with data at baseline and time point of interest|||change in LMAT score||Standard Error|Mean
1440468|NCT00931528|Secondary|Patient Marital Adjustment as Measured by the Locke's Marital Adjustment Test|The Locke Marital Adjustment Test (LMAT) is a 16-item questionnaire with scores ranging from 48 to 138 for participants. Higher scores indicate greater sexual function, sexual wellbeing, or marital adjustment. The change in LMAT score is calculated by subtracting the baseline score from the follow-up score.|Baseline, week 30 and years 1 and 2 after the start of treatment|Eligible patients with data at baseline and time point of interest.|||change in LMAT score||Standard Deviation|Mean
1440469|NCT00931528|Secondary|Overall Partner Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire-Partner (SAQ-P) Score|The SAQ-P is an 18-item questionnaire with an overall score range between 0 and 90 including the following domains: desire, dysfunction, activity, satisfaction, and fatigue. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.|Baseline, week 30 and years 1 and 2 after the start of treatment|Consenting partners of randomized eligible patients with data at baseline and corresponding time point|||change in SAQ score||Standard Deviation|Mean
1440470|NCT00931528|Secondary|Overall Patient Sexual Satisfaction as Measured by Change From Baseline in the Sexual Adjustment Questionnaire (SAQ) Score|The Sexual Adjustment Questionnaire (SAQ) is a 20-item questionnaire with an overall score range between 8 and 100 including the following domains: desire, ranging between 5 and 30; dysfunction, 0 and 25; activity, 0 and 10; satisfaction, 1 and 10; and fatigue, 1 and 5. The change in SAQ score is calculated by subtracting the baseline score from the follow-up score. A positive change indicates an improvement in sexual well-being.|Baseline, week 30 and years 1 and 2 after the start of treatment|Eligible patients with data at baseline and corresponding time point|||change in SAQ score||Standard Deviation|Mean
1440471|NCT00931528|Secondary|Overall Sexual Function as Measured by Change From Baseline in the International Index of Erectile Function (IIEF)|The IIEF is a validated 15-item for measuring patient-reported erectile function. A score of 0-5 is given to each of the 15 questions that examine 5 main domains of male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Domain scores are the sum of each item. The erectile function domain has 5 items with a score range of 1-30, orgasmic function has 2 items with a score range of 0-10, sexual desire has 2 items with a score range of 0-10, intercourse satisfaction has 3 items with a score range of 0-15, and overall satisfaction has 2 items with a score range of 2-10. Total score ranges from 0-70, with higher scores indicated better functioning. Change from baseline is calculated by subtracting baseline score from score at the time point of interest.|Baseline, week 30, and years 1 and 2 from start of treatment|Eligible patients with IIEF at baseline and corresponding time points.|||change in total IIEF||Standard Deviation|Mean
1440472|NCT00931528|Secondary|Percentage of Patients Maintaining Spontaneous (Off-drug) EF at Years 1 and 2 After Initiation of RT|"The International Index of Erectile Function (IIEF) is a validated 15-item for measuring patient-reported erectile function. Question 1 asks How often were you able to get an erection during sexual activity? Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at Years 1 and 2 are also reported with this outcome measure."|Baseline, 1 and 2 years from the start of tadalafil or placebo|All randomized eligible patients with IIEF at both baseline and corresponding time point.|||percentage of participants||95% Confidence Interval|Number
1440473|NCT00931528|Primary|Percentage of Patients Maintaining Spontaneous (Off-drug) Erectile Function (EF) at Weeks 28-30 After Initiation of Radiation Therapy (RT)|"EF is measured by Question 1 of the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item for measuring patient-reported erectile function. Question 1 asks How often were you able to get an erection during sexual activity? Responses ranged from 0=no sexual activity, to 5=Almost always or always. Higher scores indicated better functioning. All patients have erectile function prior to initiation of RT, indicated by a score of 3, 4, or 5 on IIEF Q1. Patients with a lower IIEF Q1 score at weeks 28-30 than at baseline will have less erectile function and be categorized as nonresponders. Patients with similar or improved erectile function will be categorized as responders (maintaining). Patient-related predictors of at erectile function at this time point are also reported with this outcome measure."|Baseline and 30 weeks from the start of radiation therapy|All randomized eligible patients with IIEF at both baseline and 30 week time point.|||percentage of participants||95% Confidence Interval|Number
1440829|NCT00928668|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline to Visit 6|All patients in the Safety set who have a baseline value and post dose values for each planned time.|||mmol/L||Inter-Quartile Range|Geometric Mean
1440474|NCT00931515|Primary|Participants With Improved Patient Function|"The comparison of results was based on the proportion of participants with improved outcomes.~The primary efficacy variable was treatment success based on the following criteria:~Oswestry Disability Index score improved by at least 15 points~Device success~Neurological success~Absence of major complications~Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure."|24 months||||participants|||Number
1440475|NCT00931489|Secondary|Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6|Ocular Coherence Tomography (OCT) was used to measure retinal central foveal thickness. The mean change from baseline to 6 months was determined and recorded in micrometers (µm).|6 months|"At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of non-responder following 4 months of treatment)."|||µm||Full Range|Mean
1440476|NCT00931489|Secondary|Change in Visual Acuity (VA) From Baseline to Month 6|Subjects visual acuity (VA) was tested using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letters correctly read on ETDRS chart was recorded at baseline and 6 months. Mean change was measured.|6 months|"At the 6 month timepoint - 3 of the 40 subjects enrolled into Group 1 (Wet AMD responders) had been moved to Group 3 due to persistent subretinal fluid on OCT (protocol definition of non-responder following 4 months of treatment)."|||letters gained||Full Range|Mean
1440477|NCT00931489|Primary|"Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular (Wet) Age-related Macular Degeneration Patients Compared to Population Normals."|Blood samples were collected from all study participants at baseline and Western Blot analysis was performed to identify the presence of anti-retinal and anti-RPE antibodies. Presented are the number of subjects in which the presence of anti-retinal and anti-RPE antibodies (yes/no) were recorded by a masked observer.|6 months|"The wet AMD patients' 6 month values in production of RPE or anti-retinal antibody formation are being compared to the Normal Population baseline values."|||participants|||Number
1440478|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load <=100,000 copies per mL|||participants|||Number
1440479|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL|The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Baseline viral load >100,000 copies per mL|||participants|||Number
1440480|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure|"The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures:~i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy"|48 weeks|Non-completer classes as failure|||participants|||Number
1440481|NCT00931463|Secondary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population|The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment|48 weeks|Per protocol|||participants|||Number
1440482|NCT00931463|Primary|Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization||48 weeks following randomization|modified intention-to-treat|||participants|||Number
1440483|NCT00931411|Secondary|Preferred Formulation|Number of participants that preferred one formulation over the other. All patients started the study with one cream and crossed over to the other cream at Day 42 for another 14 days. Participants were asked which they prefered.|56 days|All subjects with an evaluation after the Day 42 visit were included in this evaluation if their overall compliance was between 70 and 120%. Two patients lost to follow-up, one with no Day 56 value and 5 less than 70% compliant were not included in this analysis.|||Participants|||Number
1440484|NCT00931411|Secondary|Change in Mean Tolerance After Crossover|"Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study):~1) Very good tolerance: no objective or subjective intolerance during the study~2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign~3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign~4) Poor tolerance: symptoms requiring cessation of application, no objective sign~5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|14 Days (Day 42 to Day 56 of the study)|All subjects that had at least one evaluation after Day 7 (no day 0 visit for this parameter) were included in the analysis. Missing data were replaced using the last observation carried forward method. The same patients as in outcome #7 did not have results to carry forward and were not included in analysis (subjects swapped after crossover).|||Units on a scale||Standard Deviation|Mean
1440485|NCT00931411|Secondary|Change in Tolerance Before Crossover|"Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale:~1) Very good tolerance: no objective or subjective intolerance during the study~2) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign~3) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign~4) Poor tolerance: symptoms requiring cessation of application, no objective sign~5) Very poor tolerance: objective signs of irritative or allergic dermatitis"|7, 42 days|All subjects that had at least one evaluation after the Day 7 (no Day 0 visit for this parameter) visit were included in the efficacy evaluations. Missing data were replaced using the last observation carried forward (LOCF) method. Four patients had no Day 7 visit to carry forward and were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
1440889|NCT00928408|Primary|Change From Baseline to Month 3 in Albumin-corrected Serum Calcium||Baseline to Month 3|Full Analysis Set - Participants with Observed Data|||mmol/L||Standard Error|Mean
1452616|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 08 (Month 12; 360 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1440486|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability After Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the 2 week period after the crossover. Scale from 44 (worst) to -44 (best). The 14 Days after the crossover is the same as Day 56 in the study.|14 days (Day 42 to Day 56 of the study)|Subjects that had at least one evaluation after the Day 0 visit were in analysis if they had overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward. Two patients lost to follow-up, 1 early term and 5 less than 70% compliant were not included in this analysis and participants swapped after crossover.|||Units on a scale||Standard Deviation|Mean
1440487|NCT00931411|Secondary|Change in Mean Cosmetic Acceptability Before Crossover|The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the first 42 prior to the crossover. Scale from 44 (worst) to -44 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in the cosmetic evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
1440488|NCT00931411|Secondary|Change in Mean Quality of Life|The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worst) to 46 (best).|0, 42 days|All subjects with at least one evaluation after the Day 0 visit were included in this evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
1440489|NCT00931411|Secondary|Change in Mean Global Efficacy (by Parent)|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by parent).~0 = worsening~1 = No change~2 = Mild Improvement~3 = Moderate Improvement~4 = Good Improvement~5 = Excellent Improvement"|7, 42 days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, two missing Day 7 value and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
1440490|NCT00931411|Secondary|Change in Mean Global Efficacy (by Investigator).|"The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by investigator).~0 = worsening~1 = No change~2 = Mild Improvement~3 = Moderate Improvement~4 = Good Improvement~5 = Excellent Improvement"|7, 42 Days|All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was >70 and <120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, one missing Day 7 value and 5 less than 70% compliant were not included in this analysis.|||Units on a scale||Standard Deviation|Mean
1440491|NCT00931411|Primary|Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0|The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.|7 , 42 days|All subjects that had at least one evaluation after the Day 0 visit were included in the efficacy evaluations if their overall compliance was between 70 and 120%. Missing data were replaced using the last observation carried forward (LOCF) method. Two patients lost to follow-up and 5 less than 70% compliant were not included in this analysis.|||Percentage of change in SCORAD||Standard Deviation|Mean
1440492|NCT00931385|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|6 weeks|Treated set.|||participants|||Number
1440493|NCT00931385|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440494|NCT00931385|Secondary|Peak FVC (0-3h) Response|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values at the randomisation visit. Peak FVC (0-3h) was obtained within 0 - 3 hours after the last am dose of study drug after 6 weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440495|NCT00931385|Secondary|FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
1440543|NCT00930982|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC)|Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||giga/L||Standard Deviation|Mean
1440496|NCT00931385|Secondary|FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 12-24h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
1440497|NCT00931385|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FVC AUC 0-12h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
1440498|NCT00931385|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values at the randomisation visit. Trough values were obtained 30 minutes prior to the last am dose of study drug after six weeks of treatment . Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440499|NCT00931385|Secondary|Peak FEV1 (0-3h) Response|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values at the randomisation visit. Peak (0-3h) values were obtained within 0 - 3 hours after the last am dose after six weeks of treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.|Baseline and 6 weeks|FAS|||Liter||Standard Error|Least Squares Mean
1440500|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-3h was calculated from 0-3hours post-dose using the trapezoidal rule, divided by the observation time (3 h) to report in litres.|1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
1440501|NCT00931385|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values at the randomisation visit. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random.FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.|FAS|||Liter||Standard Error|Least Squares Mean
1440502|NCT00931385|Primary|FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment|FAS|||Liter||Standard Error|Least Squares Mean
1440503|NCT00931385|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment|Full analysis set (FAS). FAS is defined as all patients with the baseline (pre-dose) data and any evaluable post-dosing data for the first co-primary endpoint FEV1AUC 0-12h.|||Liter||Standard Error|Least Squares Mean
1440504|NCT00931359|Secondary|Percentage of Subjects With Reported Adverse Events|Adverse events were defined in the protocol and included anticipated side effects of the procedure. These events were tracked by the clinical site and did include subject-reported events. The events reported here only included side effects that were attributed by the principal investigator as being possibly to definitely related to the device or procedure. They did not include expected treatment effects, such as swelling or bruising in the treatment area.|6 months post-treatment||||Percentage of Participants|||Number
1440505|NCT00931359|Secondary|Percentage of Treatment Group Subjects That Report an HDSS Score of 1 or 2 at the 12 Month Visit|"The Hyperhidrosis Disease Severity Scale (HDSS) is a 4-point validated scale for measuring the effect of excessive sweating.~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities This outcome is only measured for the treatment group; sham group exited the study after 6 month visit."|12 months|Sham group subjects exited the study after the 6 month follow-up visit, so were not in the study at this timepoint.|||Percentage of Participants|||Number
1440506|NCT00931359|Secondary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at the 6 Month Follow-up Visit.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities"|6 months post-treatment||||Percentage of Participants|||Number
1440507|NCT00931359|Primary|Percentage of Subjects That Report an HDSS Score of 1 or 2 at 30 Days.|"The Hyperhidrosis Disease Severity Scale (HDSS) is a validated scale for measuring the effect of excessive sweating on the quality of life. It is a 4-point scale, with the following descriptors:~- My underarm sweating is never noticeable and never interferes with my daily activities~- My underarm sweating is tolerable but sometimes interferes with my daily activities~- My underarm sweating is barely tolerable and frequently interferes with my daily activities~- My underarm sweating is intolerable and always interferes with my daily activities"|30 days post-treatment|Intent to Treat Population was used. Last Observation Carry Forward was used for missing data.|||Percentage of Participants|||Number
1440508|NCT00931307|Primary|Comfort After Insertion|Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month’s wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.|3 months|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||Scale of 1 to 10||Standard Deviation|Mean
1440509|NCT00931268|Secondary|Time Until it Became Impossible to Stay Sitting|Evaluation of when (in minutes) it became impossible for the subject to stay in the sitting position on a standardized chair, at the time points 1, 3, 6, 9, 12 and 18 months compared to baseline. In this analysis “more than 60 minutes” was handled as 60 minutes.|Baseline and at 6 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.|||minutes||Standard Deviation|Mean
1440510|NCT00931268|Secondary|Adverse Event Recording|Adverse events (AEs) were collected by open questioning, investigator findings, spontaneous reports and by direct questioning in the Case Report Form (CRF).|Up to 18 months after treatment|Reported AEs, Safety population|||participants|||Number
1440511|NCT00931268|Secondary|Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)|MRI was performed at baseline and at 1, 6, 9, and 12 months to determine the implant volume, thickness, localization and the possible local displacement of the implant. At the 6, 9 and 12 month visits any displacement was evaluated with MRI by comparison to the 1-month position of the gel. The number of participants with gel displacement are shown below.|12 months after treatment||||participants|||Number
1440512|NCT00931268|Secondary|Number of Participants With Global Esthetic Improvement|Number of participants maintaining an improvement compared to baseline using the Global Esthetic Improvement Scale (GEIS) consisting of 5 grades (worse/no change/improved/much improved/very much improved), where the three latter indicates improvement. GEIS was assessed at the time points 1, 3, 6, 9, 12 and 18 months compared to pre-treatment photos.|One month and up to 18 months after treatment|The ITT population at 6 months comprised all 10 treated subjects.|||participants|||Number
1440513|NCT00931268|Secondary|Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire|A physical health summary score and a mental health summary score was generated on a rating scale of 0 to 100 where higher scores indicate better health. The change in health summary scores were assessed at the time points 3, 6, 9, 12 and 18 months compared to baseline.|Baseline and at 6 months after treatment|The physical and mental health summary scores at 6 months after treatment were compared to baseline. The ITT population comprised 8 of 10 treated subjects.|||units on a scale||Standard Deviation|Mean
1440514|NCT00931268|Secondary|Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = “no pain” to the left and 100 = “worst possible pain” to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The change in VAS pain was assessed at the time points 1, 3, 9, 12 and 18 months compared to baseline.|Baseline and up to 18 months after treatment|The VAS pain at 1, 3, 9, 12 and 18 months after treatment was compared to baseline. Of 10 treated subjects the ITT populations at each time point was: 9 (1 month), 8 (3 months), 7 (9 months), 5 (12 months) and 4 (18 months).|||mm||Standard Deviation|Mean
1440515|NCT00931268|Primary|Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting|Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = “no pain” to the left and 100 = “worst possible pain” to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated.|6 months after treatment compared to baseline|All efficacy analyses were performed using the intention to treat (ITT) population. The ITT population at baseline and 6 months comprised all 10 treated subjects.|||mm||Standard Deviation|Mean
1440516|NCT00931255|Secondary|Change in Inflammatory Marker, MCP, From Baseline||1 year||||pg/mL||Standard Deviation|Mean
1440517|NCT00931255|Secondary|Change in Inflammatory Marker, IL-6 From Baseline||1 Year||||pg/mL||Standard Deviation|Mean
1440518|NCT00931255|Secondary|Change in Inflammatory Marker : CRP From Baseline||1 year||||mg/L||Standard Deviation|Mean
1440519|NCT00931255|Secondary|Incidence of BK Nephropathy (Cumulative)||1 year||||participants|||Number
1440520|NCT00931255|Secondary|Incidence of Acute Rejection (Actual, Actuarial)||1 year||||participants|||Number
1440521|NCT00931255|Secondary|Graft Survival (Actual, Actuarial)||1 year||||participants|||Number
1440522|NCT00931255|Secondary|Change in eGFR From Baseline to 1-year||1 year||||mL/min per 1.73 m^2||Standard Deviation|Mean
1440523|NCT00931255|Secondary|eGFR||One year||||mL/min per 1.73 m^2||Standard Deviation|Mean
1440524|NCT00931255|Primary|The Composite Endpoint of Reduction of e eGFR at One Year by More Than 15% & the Progression in Fibrosis Score at One Year by >=20% Compared With the Baseline Values||One year||||participants|||Number
1440890|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 12||Month 12|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1440525|NCT00931242|Secondary|Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks||||participants|||Number
1440526|NCT00931242|Secondary|Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0|EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|12 weeks||||participants|||Number
1440527|NCT00931242|Primary|Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points|Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12|12 weeks||||participants|||Number
1440528|NCT00931164|Secondary|Neuropsychological Tests||Week 14|||||||
1440529|NCT00931164|Secondary|Functional Skills Questionnaires||Week 14|||||||
1440530|NCT00931164|Secondary|Mood and Behavior Questionnaires||Week 14|||||||
1440531|NCT00931164|Secondary|Quality of Life Questionnaires||Week 14|||||||
1440532|NCT00931164|Secondary|Mean Daily Percentage of Time That Functional Status is Affected Due to Episodes||Week 14|||||||
1440533|NCT00931164|Primary|Number of Participants Who Reported Side Effects During Home Drug Maintenance Phase||1 year||||participants|||Number
1440534|NCT00931164|Primary|Observed Safety Data During 5-day Hospitalization for Drug Dose Identification||Week 7|||||||
1440535|NCT00931164|Primary|Time Duration of AHC Episodes||Week 7|||||||
1440536|NCT00930982|Other Pre-specified|Change From Baseline in Total Bacterial Load in the Sputum|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL on Day 8. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. Decadic logarithm of colony forming units (CFUs) per gram sputum|||log10 of CFU per gram sputum||Standard Deviation|Mean
1440537|NCT00930982|Secondary|Emergence of Resistance Among Baseline Pathogens|The emergence of resistance (at least two-fold increase of Minimal inhibitory concentration, MIC, vs. baseline values) probably or possibly related to study medication among baseline pathogens was evaluated using microbiological analysis.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Participants|||Number
1440538|NCT00930982|Secondary|Emergence of New Potential Respiratory Pathogens|The emergence of new potential respiratory pathogens was evaluated using microbiological analysis. Evaluated was the cumulative number of participants with first appearance of new potential respiratory antigens at each time point. In some cases, participants attended the end of study visit later than Day 84 (up to Day 88).|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Cumulative participants|||Number
1440539|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Pathogen|Microbiological response was defined as reduction in bacterial load or eradication (measured as the number of participants with positive culture). Missing values were not imputed. Pathogens analyzed: Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Serratia marcescens, Pseudomonas aeruginosa, mucoid, Pseudomonas aeruginosa, non mucoid, Stenotrophomonas maltophilia, Achromobacter xylosoxydans, Moraxella catarrhalis, Haemophilus influenzae|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Participants|||Number
1440540|NCT00930982|Secondary|Microbiological Response of Cipro Inhale Per Participant|Microbiological response was defined as reduction in bacterial load or eradication (measured as the percentage of participants with positive culture). Missing values were not imputed.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percentage of participants|||Number
1440541|NCT00930982|Secondary|24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. Sputum color was assessed as either 'clear', or as 'yellow', 'green' or 'rust', or an assessment of 'no sputum' was made.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percentage of participants|||Number
1440542|NCT00930982|Secondary|24-hour Sputum Volume|Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. The volume of the completed sample was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||mL||Standard Deviation|Mean
1440544|NCT00930982|Secondary|Change From Baseline in High Sensitive C-reactive Protein (hsCRP)|High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.|Baseline and up to Day 42|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||mg/L||Inter-Quartile Range|Median
1440545|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS)|Participants completed the Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges between 1 and 7, 1 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Total score on a scale||Standard Deviation|Mean
1440546|NCT00930982|Secondary|Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score|Participants completed the Saint George's Respiratory Questionnaire (SGRQ). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges from 0 to 100 with 100 being the worst possible score.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Scores on a scale||Standard Deviation|Mean
1440547|NCT00930982|Secondary|Time to Exacerbation With Antibiotic Intervention|Acute exacerbation was defined according to the joint American Thoracic Society/European Respiratory Society criteria. For detailed information with regard to this definition of acute exacerbation, please refer to the detailed description in the protocol section. The time to an acute exacerbation with antibiotic intervention was determined.|Up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. NA: due to fewer than 25% of participants having an exacerbation|||Days||Inter-Quartile Range|Median
1440548|NCT00930982|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FVC was defined as the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, i.e. vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS. Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percent of predicted FVC||Standard Deviation|Mean
1440549|NCT00930982|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS). Imputation method: last observation carried forward (LOCF).|Baseline and up to end of study (planned at Day 84)|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||Percent of predicted FEV1||Standard Deviation|Mean
1440550|NCT00930982|Primary|Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).|Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm|Baseline and 29 days|Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.|||log10 of CFU per gram sputum||Standard Deviation|Mean
1440551|NCT00930969|Secondary|Participants That Consented to Wear a Holter Monitor for a Period of 24 Hours to Collect Heart Sounds Data.|When study subjects completed their six-month follow-up visit, they were asked if they would consent to wear a Holter monitor for a period of 24 hours to collect Heart Sounds data. The study subject would have to return to the center the following day to return the Holter monitor and have their ICD EGM vectors reprogrammed.|Six-month follow-up visit|A subset of participants opting to wear a Holter monitor for 24 hours to collect Heart Sounds data, and then returning the following day for device reprogramming.|||Participants|||Number
1440552|NCT00930969|Secondary|Number of Years of Stored Data in a Database of the Hearts Electrical Activity in This Specific Patient Population to be Used for Future Research.|The device in this study included an additional capacity to collect and store information about the hearts electrical activity specific to ischemic heart disease. This additional capacity of the device is not currently available in market release ICDs. There is no measure to this objective, other than reporting the number of follow-up years of data accrued, which can be used by Medtronic for additional research.|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore the number of years of stored device data to utilize for future research as collected by the implanted ICD in the remaining 173 subjects was analyzed.|||Years|||Number
1440891|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 6||Month 6|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1440553|NCT00930969|Secondary|ST Segment Changes Measured by an ICD in Subjects Who Test Positive for Ischemia During an Exercise Stress Test|Patients underwent an exercise stress test at their one month study visit. This objective was to summarize the magnitude of the hearts electrical activity signal measured by the implanted ICD during a positive exercise stress test for ischemia.|One-month follow-up visit||||millivolts||Standard Deviation|Mean
1440554|NCT00930969|Secondary|Occurrence of Spontaneous Coronary Event|During the study, spontaneous coronary ischemic events were categorized as STEMI, Non-ST elevated myocardial infarction (NSTEMI), or Unstable Angina. This objective was to provide estimates of rates per patient year for the study population. Rates are presented as: Average number of events per patient year (95% Confidence Interval)|Implant to 2 years|There were 175 subjects that consented to participate in the study, and two subjects were not implanted with an ICD by the time the study was terminated. Therefore data collected by the implanted ICD in the remaining 173 subjects was analyzed.|||Events per patient year||95% Confidence Interval|Number
1440555|NCT00930969|Primary|Number of Participants With ST Segment Changes During Myocardial Infarction|The primary objective of the study was to observe if there are any detectable ST segment changes on an electrogram (EGM) signal from an implanted cardiac defibrillator (ICD) during myocardial infarctions among study participants.|Implant to 2 years|During the study, none of the subjects presented with a ST Elevation Myocardial Infarction (STEMI). Therefore, there was not the opportunity to measure the hearts electrical activity during one of these events.|||Participants|||Number
1440556|NCT00930930|Other Pre-specified|Ability of p63 and p73 Gene Signatures to Predict Patient Response|To determine the levels of P63 and p73 in order to correlate these levels with patient response to treatment to help define a biomarker signature associated with p63/p73 dependence in triple negative breast cancers|Before treatment, on day 3-5 of week 1, and at week 12|||||||
1440557|NCT00930930|Other Pre-specified|Therapy-mediated Changes in Cell Cycle Position, Proliferation, and Apoptosis as Well as Status, Levels, and Phosphorylation State of p53, p73, and p63 and Select p53 Family Target Genes|To determine the relevance of pathway modulation in triple negative breast cancer cell networking|Before treatment, on day 3-5 of week 1, and at week 12|||||||
1440558|NCT00930930|Secondary|Number of Patients With Each Worst-grade Toxicity Response|Tables represent the number of patients with their worst-grade toxicity at each of five grades (grade 1, least severe to grade 5, most severe) following NCI Common Toxicity Criteria. Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables.|week 12|Total number of patients reported with any toxicity related to study treatment.|||participants|||Number
1440559|NCT00930930|Secondary|Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery|Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|After treatment, week 12-15|Patients reported by best overall response data. Patients are excluded if best overall response data is not accessible or not evaluable.|||participants|||Number
1440560|NCT00930930|Secondary|Number of Patients That Underwent Breast Conservation Surgery|Defined as patients that did not undergo complete removal of a cancerous breast (mastectomy).|at the time of surgery, week 15-18|participants that had breast conservation surgery|||participants|||Number
1440561|NCT00930930|Primary|Number of Patients With Pathological Complete Response|Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.|at time of surgery, week 15-18|Number of patients that had complete response. Specimens containing only non-invasive disease will be classified as complete pathologic responders|||participants|||Number
1440562|NCT00930813|Secondary|Serum Paclitaxel Levels - in Subsets of Patients||0, 1, 3 hours and pre-discharge|||||||
1440563|NCT00930813|Secondary|Change in Rutherford Grade||pre-procedure,6, 12 and 24 months|||||||
1440564|NCT00930813|Secondary|Change in Walking Impairment Questionnaire (WIQ)||pre-procedure, 6, 12 and 24 months|||||||
1440565|NCT00930813|Secondary|Change in Ankle-brachial Index||pre-procedure, 6, 12 and 24 months|||||||
1440566|NCT00930813|Secondary|Procedural Success|Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)|at procedure|||||||
1440567|NCT00930813|Secondary|Device Success|Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).|at procedure|||||||
1440568|NCT00930813|Secondary|Target Vessel Revascularization||6, 12, 24 months|||||||
1440569|NCT00930813|Secondary|Target Lesion Revascularization||6, 12, 24 months|||||||
1440570|NCT00930813|Secondary|Primary Patency of Treated Segment||6, 12, 24 months|||||||
1440571|NCT00930813|Secondary|Safety - Device Related Adverse Events||30 days|ITT|||participants|||Number
1440572|NCT00930813|Primary|Angiographic Late Lumen Loss|Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.|6 months|Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.|||mm||Standard Deviation|Mean
1440573|NCT00930787|Primary|Incidence of Surgical Site Events (SSEs)||Postoperative Day 30|Study was terminated early and no analyses were conducted.||||||
1440582|NCT00930761|Secondary|Maternal Breastfeeding at 60 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 60 days after the infant hospital discharge||||participants|||Number
1440574|NCT00930774|Secondary|Speech, Spatial and Qualities of Hearing Scale-comparative (SSQ-C)|Three subscale questionnaire that examines reported change in auditory disability for Speech, Spatial hearing and Quality of sounds. Subjects respond on a scale of -5 (‘much worse’) to +5 (much better) to indicate the change in difficulties following an intervention they have hearing in specific situations, with a lower number indicating greater difficulty. Results are presented for average total SSQ-C score which can range from -5 to +5, with higher scores indicating greater improvement.|Immediately post-intervention|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
1440575|NCT00930774|Secondary|Cognitive Self Report Questionnaire (CSRQ).|CSRQ assesses self-reported cognitive difficulties in 8 domains: Attention, Executive function, Memory, Language, Vision, Hearing, Energy,and Satisfaction. Participants respond on a 3-point Likert scale whether they perceived they improved, remained the same, or got worse as a result of an intervention. Total score is computed by summing scores on each subscale. Range for total score = -64 to +64, with higher scores indicating fewer reported cognitive difficulties.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
1440576|NCT00930774|Secondary|Time Compressed Speech Test (TCST)|the TCST assessed speech recognition for speeded speech. Sentences are presented in the sound field in quiet at with 50% and 60% time compression. Participants repeat back each sentence after it is presented.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||percent correct||Standard Deviation|Mean
1440577|NCT00930774|Secondary|Digit Span Score Measure of Auditory Working Memory|The Digit Span subtest of the Wechsler Adult Intelligence Scale 3rd edition (WAIS-III) assessed auditory working memory. It consists of a Digit Span Forward task in which individuals to repeat numbers in the same sequence as they were presented verbally, and a Digit Span Backward task in which individuals repeat back the numbers in the reverse order to which they were heard. Data are summed to compute a Digit Span total score. Possible range of scores is 0 to 30, with higher scores indicating better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
1440578|NCT00930774|Secondary|Staggered Spondaic Word Test|Dichotic listening test in which two spondaic words are presented, one to each ear of the listener, in an overlapping fashion such that the first syllable of the first word is presented in isolation, the second syllable of the first word is presented simultaneously with the first syllable of the second word, and the second syllable of the second word is presented in isolation. Total number of test spondee pairs = 40.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||total errors||Standard Deviation|Mean
1440579|NCT00930774|Secondary|Hearing in Noise Test|Hearing In Noise Test assesses speech understanding in noise assessed. Sentences are presented in a background of noise. The signal to noise ratio is varied adaptively to obtained the signal to noise ratio at which participants can correctly repeat back 50% of sentences presented in speech-shaped noise is determined. A lower signal to noise ratio indicates better performance.|Immediately post-intervention between weeks 8 and 12.|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||Decibels (signal to noise ratio)||Standard Deviation|Mean
1440580|NCT00930774|Primary|Stroop Color and Word Test|Measure of processing interference that assesses the ability to cope with cognitive stress and process complex input. It consists of a Word Page with color words printed in black ink, a Color Page with 'Xs' printed in color, and a Color-Word Page with words from the first page printed in colors from the second page (the color and the word do not match). The test-taker looks at each sheet and moves down the columns, reading words or naming the ink colors as quickly as possible within a time limit. Interference raw scores were converted into t-scores for analysis. T-score benefit was the analytic metric used. T-score benefit = post-intervention score minus baseline score|Baseline and Immediately post-intervention (between weeks 8 and 12).|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||t-score benefit||Standard Deviation|Mean
1440581|NCT00930774|Primary|Competence Score From the Psychosocial Impact of Assistive Devices Scale (PIADS)|Assesses the impact a rehabilitative intervention has on perceived Competence (perceived functional capability, independence and performance). Responses are reported on a 7-point scale that ranges from -3 (maximum negative impact) to +3 (maximum positive impact). The mid-point, zero, indicates no impact or no perceived change|Immediately post-intervention between weeks 8 and 12|The number of participants analyzed differs from the number of baseline enrollees due to participant attrition. Specifically, one individual in arm 1 (FM system), eleven participants in arm 2 (Auditory training), four in arm 3 (FM system and auditory training) and three in arm 4 (standard of care) chose not to attend the follow-up visit.|||units on a scale||Standard Deviation|Mean
1440583|NCT00930761|Primary|Maternal Breastfeeding 7-15 Days After Discharge|Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the first follow-up visit (7-15 days after discharge)|Analysis was by intention to treat (ITT)|||participants|||Number
1440584|NCT00930761|Secondary|Maternal Breastfeeding at 30 Days After Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At 30 days after the infant hospital discharge|Analysis by intention to treat (ITT)|||participants|||Number
1440585|NCT00930761|Primary|Maternal Breastfeeding at Infant Discharge|Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).|At the time of the infant hospital discharge|Analysis by intention to treat (ITT)|||participants|||Number
1440586|NCT00930722|Secondary|Number of Participants With Preference for add-on Anti-hypertensive Therapy|The first add-on antihypertensive therapy for each participant was the first additional antihypertensive medication since initiation of Quinapril. If the participant did not require any such add-on medication, the first add-on antihypertensive therapy was “None”.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.|||Participants|||Number
1440587|NCT00930722|Secondary|Mean Daily Dose of Study Medication|The mean daily dose of the study medication was calculated by dividing the total dose (sum of the daily doses) in the study by the treatment duration.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.|||mg||Standard Deviation|Mean
1440588|NCT00930722|Secondary|Duration of Monotherapy With Quinapril|Time in weeks to the first “taking additional antihypertensive medication” since Quinapril therapy began.|Baseline up to week 52 or early termination|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed. Due to limited number of participants available, the analysis could not be performed.|||Weeks||Inter-Quartile Range|Median
1440589|NCT00930722|Secondary|Number of Participants With Achievement of BP Goal at Week 52|The status of achieving a participant’s goal BP at week 52 was yes (at goal) or no (not at goal). The BP goal also depended on the participant’s status of “DM or renal disease”. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.|Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.|||Participants|||Number
1440590|NCT00930722|Secondary|Number of Participants Achieving BP Goal at Week 12|The status of achieving a participant’s goal BP at Week 12 was yes (at goal) or no (not at goal). The BP goal also depended on the participant’s status of “Diabetes Mellitus (DM) or renal disease”. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.|Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Subgroup analysis was performed for each subgroup of participants in the FAS defined by DM or renal disease status. Missing values were imputed by LOCF.|||Participants|||Number
1440591|NCT00930722|Secondary|Change From Pre-treatment in DBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.|||mmHg||Standard Deviation|Mean
1440592|NCT00930722|Secondary|Change From Pre-treatment in SBP at Week 0|Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.|Pre-treatment and Week 0|FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.|||mmHg||Standard Deviation|Mean
1440593|NCT00930722|Secondary|Change From Baseline in DBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.|||mmHg||Standard Deviation|Mean
1440594|NCT00930722|Secondary|Change From Baseline in SBP at Week 52|Value at week 52 minus value at baseline.|Baseline and Week 52|The “full analysis set – follow up” (FAS-FU) included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.|||mmHg||Standard Deviation|Mean
1440595|NCT00930722|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by LOCF.|||mmHg||Standard Deviation|Mean
1440596|NCT00930722|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12|Value at week 12 minus value at baseline.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by last-observation-carried forward (LOCF).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1440626|NCT00930293|Secondary|Weeks to Depression Remission|"Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).~Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)"|Measured at baseline and weekly for up to 20 weeks of treatment||||weeks||Standard Error|Mean
1440597|NCT00930722|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to Week 52|Full analysis set (FAS) included participants who received at least 1 dose of study medication including those who took it before enrollment.|||Participants|||Number
1440598|NCT00930644|Secondary|Number of Subjects Achieving PN/IV Reduction|The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.|24 Months or Last Dosing Visit||||participants|||Number
1440599|NCT00930644|Primary|Absolute Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.|24 months||||Liters||Standard Deviation|Mean
1440600|NCT00930644|Primary|Percent Change in PN/IV Volume by Visit|The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.|24 months||||percent change||Standard Deviation|Mean
1440601|NCT00930553|Secondary|Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison|EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
1440602|NCT00930553|Secondary|Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6|EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
1440603|NCT00930553|Secondary|Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison|FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
1440604|NCT00930553|Secondary|Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6|FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
1440605|NCT00930553|Secondary|Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison|"SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “CAMMS323” and “CAMMS324 participants, respectively."|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
1452617|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 07 (Month 9; 270 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1440606|NCT00930553|Secondary|Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
1440607|NCT00930553|Secondary|Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison|"SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “CAMMS323” and “CAMMS324 participants, respectively."|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
1440608|NCT00930553|Secondary|Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “alemtuzumab treatment CAMMS323 extension group”, “alemtuzumab Treatment CAMMS324 Extension” group, respectively),Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
1440609|NCT00930553|Secondary|Percentage of Relapse Free Participants|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
1440610|NCT00930553|Secondary|Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6|Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5 and 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1440611|NCT00930553|Secondary|Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity|Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
1440612|NCT00930553|Secondary|Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6|Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
1440627|NCT00930293|Primary|Number of Participants Meeting Depression Remission Criteria|Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7|Measured at baseline and weekly for up to 20 weeks of acute treatment||||participants|||Number
1440628|NCT00930176|Primary|FX:C Half-life|Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment|At Baseline and at 6 months post-Baseline||||hours||Geometric Coefficient of Variation|Geometric Mean
1440613|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date.|Retreatment Baseline, Year 1, 2 and 3 after retreatment|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.|||percentage of participants|||Number
1440614|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||percentage of participants|||Number
1440615|NCT00930553|Secondary|Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity|Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually.|Year 3, 4, 5 and 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
1440616|NCT00930553|Secondary|Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points.|Retreatment baseline, Year 1, 2 and 3 after retreatment baseline|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.|||units on a scale||Standard Deviation|Mean
1440617|NCT00930553|Secondary|Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “CAMMS323 participants” and “CAMMS324 participants” respectively.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||units on a scale||95% Confidence Interval|Mean
1440618|NCT00930553|Secondary|Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 [NCT00530348] or CAMMS324 [NCT00548405]) value from EDSS scores at specified time points.|"Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively), Year 3, 4, 5, 6"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
1440619|NCT00930553|Secondary|Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study|SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Extension study (CAMMS03409) baseline up to Extension Year 2|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. Number of participants analyzed = participants with available data for this outcome measure.|||Participants|||Count of Participants
1440629|NCT00930176|Primary|FX:C Incremental Recovery|"Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg).~Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment"|At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)||||IU/dL per IU/kg||Geometric Coefficient of Variation|Geometric Mean
1440680|NCT00929656|Secondary|Upper Extremity Fugl-Meyer Motor Assessment Change|Change in Score from Pre-intervention to Post-Intervention. This outcome measures arm motor control; the ability to move outside of pathologic synergistic patterns. It is a measure of impairment in Body Structure/Function. Total score ranges from 0-66, with 0 indicative of no movement and 66 considered normal motor control.|Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||units on a scale||Standard Error|Mean
1440620|NCT00930553|Secondary|Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6|SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure.|Baseline (Year 0) up to Year 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||Participants|||Count of Participants
1440621|NCT00930553|Primary|Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison|SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||Participants|||Count of Participants
1440622|NCT00930553|Primary|Number of Participants With Sustained Accumulation of Disability (SAD)|"SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for “alemtuzumab treatment CAMMS323 extension group and “alemtuzumab Treatment CAMMS324 Extension” group, respectively."|Baseline (Year 0) up to Year 6|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324.|||Participants|||Count of Participants
1440623|NCT00930553|Primary|Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment.|Year 1 prior to retreatment, Year 1, 2, 3 after retreatment|Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study.|||relapses per participant per year||95% Confidence Interval|Number
1440624|NCT00930553|Primary|Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group.|Baseline (Year 0 of initial studies) up to Year 4|Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409.|||relapses per participant per year||95% Confidence Interval|Number
1440625|NCT00930553|Primary|Annualized Relapse Rate (ARR)|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation.|"Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for “Alemtuzumab Treatment CAMMS323 Extension group and “Alemtuzumab Treatment CAMMS324 Extension” group, respectively)"|Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure.|||relapses per participant per year|||Number
1440661|NCT00929708|Primary|FEV1, E24−26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)|change from baseline|24h, 26h||||Litre||Standard Deviation|Mean
1440630|NCT00929981|Secondary|Change From Baseline in Investigator-rated Total Signs and Symptoms of CD Score at First, Second, Third and Final Follow-up Visits|Investigator-rated total signs and symptoms score of CD included pruritus, erythema, induration, vesiculation, edema or other specific sign or symptom rated on a 5 point scale of 0 – 4 (0=none, 1=mild, 2=moderate, 3=severe, 4=extreme) with a total score of 0 - 20 (lower score was preferred).|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
1440631|NCT00929981|Secondary|Change From Baseline in Participant-rated Pruritus Score at First, Second, Third and Final Follow-up Visits|Participant-rated pruritus score of lesions rated the severity of pruritus suffered in the past 24 hours on an 11-point NRS where 0 = no pruritus and 10 = most severe possible pruritus.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
1440632|NCT00929981|Secondary|Change From Baseline in Participant-rated Clinical Severity Score of Lesions at First, Second, Third and Final Follow-up Visits|Participant-rated clinical severity score of lesions rated the severity of all symptoms in the past 24 hours on an 11-point Numerical Rating Scale (NRS) where 0 = No lesions and 10 = Most severe possible lesions.|Baseline,First Follow-up(between Day 6-10 of start of treatment),Second(Day 5-28),Third(between Day 6-10 after EOT),Final(between Day 25-35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
1440633|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Final Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Final follow-up visit (between Day 25 to 35 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
1440634|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the Third Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Third follow-up visit (between Day 6 to 10 after EOT)|FAS population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
1440635|NCT00929981|Secondary|Treatment Status (Success/Failure) of CD at the First Follow-up Visit|The signs and symptoms of CD were rated on PGA 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|First follow-up visit (between Day 6 to 10 after start of treatment)|FAS population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
1440636|NCT00929981|Primary|Treatment Status (Success/Failure) of Contact Dermatitis (CD) at the Second Follow-up Visit|The signs and symptoms of CD were rated on Physician’s Global Assessment (PGA) 5-point scale (range, 0 – 4 scale):0 - no clinically relevant reaction; 1- macular erythema with induration; 2 - weak (non-vesicular) reaction with erythema, infiltration, and possible papules; 3 - strong (edematous or vesicular) reaction; 4 - extreme (spreading, bullous, ulcerative) reaction. “Success” was defined as a score of 0 or 1 and “failure” was defined as a score of 2, 3, or 4.|Second follow-up visit (Day 5-28)|Full analysis set (FAS) population included all participants who received at least 1 dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
1440637|NCT00929864|Secondary|Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population|The induction of autoantibodies was defined as participant’s antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729). Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline. Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate.|Day 1 to Day 729|ITT population was defined as all participants randomized into the study who received at least one dose of study drug; number analyzed was ITT participants with data at each time point and who had negative ANA or dsDNA at baseline (m)|||Percentage of participants||95% Confidence Interval|Number
1440638|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 729|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.|||incidence/100 person-years||95% Confidence Interval|Number
1440639|NCT00929864|Secondary|Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population|Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all subjects randomized into the study who received at least one dose of study drug. Poisson distribution was used to construct the 95% CIs.|||incidence/100 person-years||95% Confidence Interval|Number
1440640|NCT00929864|Secondary|Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population|Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729. BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign). SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films. Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2). Proportion n/m (%)=number meeting criteria (n); number analyzed (m). SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt). mSvdHS=summary of erosion severity in 32 hand and 12 foot joints. Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity. BL: radiographic data within 14 days or less of first dose.|Baseline to Day 729|ITT population: all subjects randomized into the study who received at least one dose of study drug. Number analyzed: m=number of ITT participants with both BL and post-BL total score: Day 365: m=295, 297;Day 729 m=257 and 260, in abatacept and adalimumab arms, respectively. n=number without progression. CI based on normal approximation.|||percentage of participants||95% Confidence Interval|Number
1440641|NCT00929864|Secondary|Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population|Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25. The 24 Month Period includes data up to 56 days post the last dose in the 24 month period. Poisson distribution used to construct the 95% CIs.|Day 1 to Day 729|ITT population: all participants randomized into the study who received at least one dose of study drug. Participants with a pre-specified local injection site event at 24 Months: 13, 34, in abatacept and adalimumab arms, respectively. 24 Month Exposure=579.21, 532.99, respectively.|||incidence/100 person years||95% Confidence Interval|Number
1440642|NCT00929864|Secondary|Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population|n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk. Proportion (%) = n/N. 12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period.|Day 1 to 12 Months|The ITT analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 12/318, 30/328 in abatacept and adalimumab, respectively. CI based on normal approximation.|||percentage of participants||95% Confidence Interval|Number
1440643|NCT00929864|Primary|The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population|Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient’s RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale.|Day 1 to Day 365|The intent to treat (ITT) analysis population was defined as all participants randomized into the study who received at least one dose of study drug. n/N = 206/318 and 208/328 in the abatacept and adalimumab arms, respectively.|||percentage of participants||95% Confidence Interval|Number
1440644|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right shoulder is a measure of how well the participant can move the right shoulder. The participant gently raises the right shoulder (with right arm) as far as possible, and this distance is measured in degrees. The change for ROM for the right shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the right shoulder can move further more easily than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the right shoulder can move less and not as far to the left side than before getting the treatment.|baseline and one hour||||degrees||Standard Deviation|Mean
1440662|NCT00929708|Primary|FEV1, E0−4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)|change from baseline|0,5 min, 15 min, 60 min, 2 h, 4 h||||Litre||Standard Deviation|Mean
1440663|NCT00929695|Secondary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
1440645|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Right Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the right side of the neck is a measure of how well the neck can move to the right side. The participant gently tilts their neck to the right side as far as possible, and this distance is measured in degrees. The change for ROM for the right side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the right side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the right side than before getting the treatment.|baseline and one hour||||degrees||Standard Deviation|Mean
1440646|NCT00929773|Primary|Change in Self-reported Degree of Pain in the Neck-shoulder Region on the 0-100 Visual Analog Scale (VAS)|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. The change is calculated as the difference from the VAS score recorded at baseline to the VAS score recorded one hour after study treatment administration. A positive change (+) means that the pain got worse and a negative change (-) means that the pain got better.|baseline and one hour||||units on a scale||Standard Deviation|Mean
1440647|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Shoulder From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left shoulder is a measure of how well the participant can move the left shoulder. The participant gently raises the left shoulder (and left arm) as far as possible, and this distance is measured in degrees. The change for ROM for the left shoulder is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and can move the left shoulder better and further than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the left shoulder can move less easily and not as far than before getting the treatment|one hour||||degrees||Standard Deviation|Mean
1440648|NCT00929773|Secondary|Change in Range of Motion (ROM) for the Left Side of the Neck From Baseline to One Hour After Study Treatment.|Range of motion (ROM) for the left side of the neck is a measure of how well the neck can move to the left side. The participant gently tilts their neck to the left side as far as possible, and this distance is measured in degrees. The change for ROM for the left side of the neck is measured as the difference in degrees of ROM recorded from baseline to one hour after study treatment. If the change is positive (+), this means that ROM has gotten better and the neck can move further to the left side than before getting the treatment. If the change is negative (-), this means that ROM has gotten worse and the neck can move less to the left side than before getting the treatment|baseline and one hour||||degrees||Standard Deviation|Mean
1440649|NCT00929773|Primary|Number of Participants Whose Self-reported Degree of Pain on the Visual Analog Scale (VAS) in the Neck and Shoulder Area Decreased by 30% or More From Before to After Study Treatment.|Self-reported degree of pain in the neck and shoulder region on the Visual Analog Scale (VAS). The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment.|baseline and one hour||||participants|||Number
1440650|NCT00929734|Secondary|Relative Change in Interleukin 6||Baseline to 3 months|Complete case analysis|||percent change||Inter-Quartile Range|Median
1440651|NCT00929734|Secondary|Relative Change in High-sensitivity C-reactive Protein||Baseline to 3 months|Complete case analysis|||percent change||Inter-Quartile Range|Median
1440652|NCT00929734|Secondary|Relative Change in FEV1||Baseline to 3 months|Complete case analysis|||percent change||95% Confidence Interval|Mean
1440653|NCT00929734|Primary|Relative Change in Reactive Hyperemia Index (RHI)|Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.|Baseline to 3 months|Complete case analysis|||percent change||95% Confidence Interval|Mean
1440654|NCT00929708|Secondary|Total Score SGRQ-C (St George’s Respiratory Questionnaire for COPD)|The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)|At baseline (visit 2) and after 4 weeks of treatment (visit 5).||||Score||Standard Deviation|Mean
1440655|NCT00929708|Secondary|Overall Mean CCQ (Clinical COPD Questionnaire)|Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.|Mean over week 0, mean over week 1, mean over week 2, and mean over week 4||||score on scale||Standard Deviation|Mean
1440656|NCT00929708|Secondary|Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)|Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.|Daily, during run-in and treatment||||total score||Standard Deviation|Mean
1440657|NCT00929708|Secondary|Total Number of Reliever Medication Inhalations Per 24h|Change from run-in|During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.||||Number of reliver inh.||Standard Deviation|Mean
1440658|NCT00929708|Secondary|FEV1 Post Salbutamol Inhalation|Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5|Baseline (visit 2) and 26 h after the last morning dose (visit 5).||||Litre||Standard Deviation|Mean
1440659|NCT00929708|Secondary|AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.|||nmol*h/L||Full Range|Geometric Mean
1440660|NCT00929708|Secondary|Cmax; the Highest Plasma Concentration of AZD3199 Measured|PK is only measured for AZD3199|0,15 min, 1, 4 and 24 hours post dose|AZD3199 plasma data were available for 178 of the 199 randomized patients, but data from 2 patients in AZD3199 200 mcg group were excluded from analysis because most of the values were below LOQ.|||nmol/L||Full Range|Geometric Mean
1440665|NCT00929695|Secondary|Secondary Therapy for Acute GVHD Beyond Prednisone|This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.|At approximately 100 days after transplant||||percentage of participants|||Number
1440666|NCT00929695|Secondary|Progression to Grade III-IV Acute GVHD|Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.|At approximately 100 days after transplant||||percentage of participants|||Number
1440667|NCT00929695|Secondary|Recurrent or Progressive Malignancy|Percentage of relapse estimated by cumulative incidence methods|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
1440668|NCT00929695|Secondary|Non-relapse Mortality|Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.|At 12 months after the start of prednisone therapy||||percentage of participants|||Number
1440669|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Quality of Life|Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.|Baseline and then every other week until 42 days after starting treatment||||units on a scale||Full Range|Mean
1440670|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hypertension|The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.|Baseline and then through 42 days after starting treatment||||medications||Full Range|Mean
1440671|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Myopathy|Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.|Baseline and then weekly until 42 days after starting treatment||||units on a scale||Full Range|Mean
1440672|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)|The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.|Baseline and through 100 days of treatment||||percentage of participants|||Number
1440673|NCT00929695|Secondary|Prednisone-associated Toxicity as Assessed by Hyperglycemia|Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.|Baseline and then through 42 days after starting treatment||||mg/dL||Standard Error|Mean
1440674|NCT00929695|Primary|Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment|The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.|At day 42 after initiation of treatment|From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification.|||milligrams per kilogram||Standard Deviation|Mean
1440675|NCT00929669|Secondary|Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.|Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.|12 months||||number of participants|||Number
1440676|NCT00929669|Primary|Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI|MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.|12 months||||participants|||Number
1440677|NCT00929656|Secondary|Motor Activity Log - How Well Change|"Self-Report of How Well paretic UE performed completing 30 functional tasks. Each task is reported on a 0-5 scale with 0 representing Unable to use my paretic hand to perform that task and 5 representing My paretic hand performs that task as well as it did before the stroke. A 5 on each task would be considered normal."|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||Units on a scale||Standard Error|Mean
1440678|NCT00929656|Secondary|Motor Activity Log - Amount of Use Change|"Self-Report Amount of Use of Paretic UE to complete 30 functional tasks. Each task is reported on a 0-5 scale with 0 representing did not use my paretic hand at all for that task and 5 representing I used my paretic hand as much as before the stroke to complete that task. A 5 on each task would be considered normal."|Change Between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||Units on a scale||Standard Error|Mean
1440679|NCT00929656|Secondary|Grip Strength Change|Change in Paretic hand grip strength from pre- to post-intervention. Grip strength measured by hand-held dynamometer. An average of 3 5-second trials was used for analysis.|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||kilograms||Standard Error|Mean
1440892|NCT00928408|Primary|Incidence of an Albumin-corrected Serum Calcium Concentration ≤ 2.6 mmol/L (10.3 mg/dL) at Month 3||Month 3|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1440681|NCT00929656|Primary|Wolf Motor Function Test Change|Change, in seconds, between Pre-intervention and post-intervention (4 wks following pre-intervention). The time to complete 15 separate upper extremity functional tasks are recorded. These 15 separate timed events are averaged to provide one time, in seconds. This is considered an Activity Measure on the WHO ICF model.|Change between Pre-intervention (baseline) to Post-intervention (4 wks following pre-intervention)||||seconds||Standard Error|Mean
1440682|NCT00929643|Secondary|Percentage of Participants by Diagnosis at Discharge||Month 6 or study exit|FAS|||Percentage of participants|||Number
1440683|NCT00929643|Secondary|Percentage of Participants With Specific Pathogen||Baseline up to 6 months|FAS|||Percentage of participants|||Number
1440684|NCT00929643|Primary|Duration of Hospitalization (by Failure of Initial Empiric Treatment)|Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch).|Baseline up to 6 months|FAS; n=number of participants with nonmissing data|||Days||Standard Deviation|Mean
1440685|NCT00929643|Primary|Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy|Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection.|Baseline up to 6 months|FAS; n=number of participants in which failure could be assessed|||Percentage of participants|||Number
1440686|NCT00929643|Primary|Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)||Baseline up to 6 months|FAS|||Percentage of participants|||Number
1440687|NCT00929643|Primary|Duration of Hospitalization|Overall health care resource utilization was analyzed using mean duration of hospitalization.|Baseline up to 6 months|Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.|||Days||Standard Deviation|Mean
1440688|NCT00929578|Secondary|Fluphenazine Serum Levels Measured at Baseline, 2 Hours Post Dose and 1 Week Post Dose.|Number of participants with fluphenazine serum levels > 0.200ng/ml, at baseline, 2 hours post dose and 1 week post dose.|1 week|All participants who were enrolled and completed baseline and week 1 were included.|||participants|||Number
1440689|NCT00929578|Secondary|Safety Outcome Measures|adverse events will be recorded and monitored. Adverse events will be noted in a separate chart.|8 weeks|All participants who completed enrollment.|||All Study Participant|||Number
1440690|NCT00929578|Secondary|Change in the Target Lesion Visual Analog Scale (VAS) Score for Pruritus Evaluated at Baseline and 4 Weeks|Visual Analog Scale (VAS) score for pruritus. Subjective measurement of pruritus on an analog scale with a single mark denoting self-perceived pruritus: Minimum 0mm for no itch, Maximum 100mm for worst itch imaginable. Scores are measured in millimeters. This secondary outcome is a percentage improvement from baseline score for pruritus. Improvement is negative, worsening is positive.|4 weeks|Participants who completed entire trial.|||percentage of baseline pruritus||Standard Deviation|Mean
1440691|NCT00929578|Primary|Change in Target Lesion Scoring Evaluated at Baseline and 4 Weeks|Actual change in target lesion score comparing 4 week score with baseline score. Improvement is positive, worsening is negative. Target lesions scores range from 0 (no disease) to 12 (severe disease), and are scored based on the sum of erythema (0-4), induration (0-4) and scale (0-4) scores.|4 weeks|All participants who successfully were enrolled.|||units on a scale||Standard Deviation|Mean
1440692|NCT00929526|Secondary|Number of Subjects With Pregnancies and Pregnancy Outcomes.|Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
1440693|NCT00929526|Secondary|Number of Subjects With Medically Significant Conditions (MSCs).|MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
1440694|NCT00929526|Secondary|Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.||During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
1440695|NCT00929526|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.|NOCDs included autoimmune diseases, diabetes mellitus.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
1440719|NCT00929383|Primary|Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)|The number of Wingspan Stents successfully deployed across the target lesion.|Peri-procedural|(ITT) Intent-to-treat|||patients w stent implanted|||Number
1440893|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 12|Baseline is pre-cinacalcet.|Month 12|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1440696|NCT00929526|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12|The analysis was performed on all subjects from the Total Vaccinated cohort who came for the current follow-up study and for whom data were available.|||Subjects|||Number
1440697|NCT00929526|Secondary|HPV-16 and HPV-18 Antibody Titers|Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity M48 EXT- NCT00316693 included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.|||Titers||95% Confidence Interval|Geometric Mean
1440698|NCT00929526|Secondary|Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.|Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.|At Month 0 and at Month 12|The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available in this current follow-up study for antibodies against at least one study vaccine antigen component.|||Subjects|||Number
1440699|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.|"Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between.~HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
1440700|NCT00929526|Secondary|Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.|"Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days).~For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
1440701|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.|HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.|From Month 0 up to Month 12|The analysis was performed in subjects who were negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
1440702|NCT00929526|Secondary|Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.|"For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
1440703|NCT00929526|Secondary|Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC.~HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
1440704|NCT00929526|Secondary|Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC.~HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|From Month 0 up to Month 12|The analysis was performed in subjects who were DNA negative at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered, regardless of their initial serostatus and for whom data concerning efficacy outcome measures were available in this current follow-up study.|||Subjects|||Number
1440705|NCT00929526|Secondary|Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.|"Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC).~For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for HPV DNA at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
1440756|NCT00929240|Secondary|Percentage of Participants Who Died (Maintenance Phase Data Cutoff October 4, 2013)||Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||percentage of participants|||Number
1440706|NCT00929526|Primary|Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.|"Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC).~Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR).~For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.~For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type."|From Month 0 up to Month 12|The analysis was performed in subjects who were seronegative at baseline and negative for human papillomavirus (HPV) desoxyribonucleic acid (DNA) at baseline and Month 6 in the primary study (NCT00316693) for the HPV-type considered and for whom data concerning efficacy outcome measures were available in this follow-up study.|||Subjects|||Number
1440707|NCT00929500|Secondary|Muscle Strength|MAST sessions were held twice a week for 16 weeks. Each exercise session consisted of 10 min of warm-up, 15–30 min of interval aerobic training by cycle ergometer according to the program, 20 min of strength training exercises, and 10 min of cool-down by stretching. The target heart rate (HR) increased progressively from 50% up to 80% of HR reserve by the end of the intervention period.The Karvonen formula ([(HRmax – HRrest)×(0.50 to 0.80)] + HRrest) was used to calculate the target HR. During every training session a new wireless computerized ECG monitoring system was used. After aerobic training, the strength training program was performed. Exercises used body mass as resistance and included squat, step-up-squat, step-up, heel rise, and sit-ups. Dumbbells were used as extra weight (5 or 10% of body weight) during other exercises except for sit-ups. The control group participated in an educational session once a month and kept physical activity diaries during the intervention period.|At baseline and after 4 months of intervention||||W||Standard Deviation|Mean
1440708|NCT00929500|Secondary|Trail Making Test|The Trail Making (TM) test is a measure of shifting attention. Participants are required to sequentially connect a series of numbered circles (Part A), and then to alternate between numbers and letters sequentially (Part B) (e.g., A-1-B-2-C-3..). Any participant who has not completed Part B within the standard 5 minutes (300 seconds) allotted for the task will be considered unable to complete the task. The scores in Part A (TM-A), Part B (TM-B) T scores ( age, education adjusted), and their difference (TM-B –TM-A) were calculated and used to measure executive function, i.e., lower scores indicates better performance.|At baseline and after 4 months of intervention||||T-score||Standard Deviation|Mean
1440709|NCT00929500|Secondary|Cerebral Blood Flow Velocity (BFV)|Cerebral BFV was monitored using Transcranial Doppler Ultrasound.11 The middle cerebral artery was insonated from the temporal window by placing the 2-MegaHertZ (MHz) probe against the skin of the temporal region above the zygomatic arch. The probe was positioned to obtain maximal BFV and was fixed at the desired angle using a 3-dimensional positioning system. Once instrumented, BFV was continuously recorded throughout ten minutes of supine rest and 10-minutes on a table tilted to 80° from the horizontal position (head-up with foot plate support).|At baseline and after 4 months of intervention||||cm/s||Standard Deviation|Mean
1440710|NCT00929500|Primary|Maximal Oxygen Uptake|To obtain peak oxygen uptake (VO2max; ml−1/min−1/kg), a symptom-limited exercise stress test was performed on a cycle ergometer. The test was preceded by a 2-minute warm-up at the intensity of 20 W. The first test load was 20 W, and was increased by 20 W at each 2-minute stage until the participants could no longer continue, i.e., they were unable to maintain pedaling frequency > 40 rpm, they achieved a respiratory exchange ratio of more than 1.0, or clinical criteria for test termination was observed. VO2max was measured and monitored with a breath-by-breath gas exchange system.|At baseline and after 4 months of intervention||||ml/kg/min||Standard Deviation|Mean
1440711|NCT00929474|Secondary|All-cause Cardiovascular and Heart Failure Hospitalizations; All-cause Cardiovascular and Heart Failure Mortality; Changes in Paced/Sensed AV and V-V Delays; Percent Atrial and Ventricular Pacing||Not assessed|||||||
1440712|NCT00929474|Secondary|6-minute Hall Walk; Intrinsic QRS Width; Echo Measurements (End Diastolic Volume, End Systolic Volume, Ejection Fraction, Left Ventricular Mass, Mitral Regurgitation, Tricuspid Regurgitation, and Interventricular and Intraventricular Mechanical Delays)||Not assessed|||||||
1440713|NCT00929474|Secondary|Modified Specific Activity Scale (SAS); Quality-of-life (QOL) Score as Measured by Minnesota Living With Heart Failure (MLHF) Questionnaire||Not assessed|||||||
1440714|NCT00929474|Primary|Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)|The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.|Not assessed|||||||
1440715|NCT00929383|Secondary|Rate of Restenosis|"The rate of restenosis at 12 months was defined as the degree of residual stenosis greater than 50% as determined by the study sites using the WASID method. There was a 10.4% rate of restenosis >50% or 8 patients out of 77 analyzed. The differences in this analysis population N=77 vs. ITT N= 82 populations results from exclusion of N=4 patients with no stent implanted and N=1 patient who died prior to any follow up measures of restenosis.~The WASID method is a standardized protocol for measuring intracranial arterial stenosis.~[1-(Dstenosis/Dnormal)] x100=% stenosis (where D=vessel diameter)"|12 Months|There were only N=77 patients available for analysis of restenosis at 12 months. This differs from the original N=82 ITT population in that denominator is based on the number of subjects available at 30 day follow up. Five subjects who exited the study at discharge were excluded from the analysis (no stent implanted (4), death (1)).|||participants|||Number
1440716|NCT00929383|Secondary|Cumulative Stroke Rate at 12 Months|The cumulative stroke rate at 12 months (any stroke or neurological death </= 30 days or any ischemic stroke in territory >/= 31 days is 15.9% or 13 events per 82 patients|12 months|(ITT) Intent-to-treat|||participants|||Number
1440717|NCT00929383|Primary|Rate of Recurrent Ischemic Stroke in the Target Territory|The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.|12 Months|(ITT) Intent-to-treat|||participants|||Number
1440718|NCT00929383|Primary|Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)|"Any stroke or neurological death at </= 30 days will be included in the cumulative morbidity and mortality rate.~There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients."|30 days|(ITT) Intent-to-treat|||participants|||Number
1440720|NCT00929357|Secondary|Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)|Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (<20 EU) or positive (≥20 up to >60 EU).|Baseline (Day 0) up to 48 months|Evaluable population; N=number of participants with evaluable data for CCP. CCP value as a laboratory diagnostic marker was collected within the complete timeframe and was documented only once; calculation for change in value not applicable.|||participants|||Number
1440721|NCT00929357|Secondary|Number of Participants With Change From Baseline in Rheumatoid Factor (RF)|Rheumatoid Factor measured as a titer and categorized as negative (<1:16 ratio) or positive. A ratio >1:16 indicates a higher level of RF.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for Positive or Negative status for DMARDS and Biologics, respectively.|||participants|||Number
1440722|NCT00929357|Secondary|Change From Baseline in C-reactive Protein (CRP)|C-reactive protein measured as milligrams per liter (mg/l)|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.|||mg/l||Standard Deviation|Mean
1440723|NCT00929357|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.|||mm/h||Standard Deviation|Mean
1440724|NCT00929357|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline (Day 0) up to 48 months|Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.|||scores on a scale||Standard Deviation|Mean
1440725|NCT00929357|Secondary|Number of Participants Without Erosions|Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.|Baseline (Day 0) up to 48 months|Evaluable population. Ratingen scores were calculated based on radiographic assessment, but score of 0 (no erosions) was not reported separately; data not summarized.|||participants|||Number
1440726|NCT00929357|Secondary|Number of Participants Without Radiographic Progression|An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.|Baseline (Day 0) up to 48 months|Evaluable population|||participants|||Number
1440727|NCT00929357|Primary|Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression|Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, <20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = >80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 [months])*12 months.|Baseline (Day 0) up to 48 months|Evaluable population: all participants who had provided two evaluable, consecutive radiographs of the hands and forefeet, taken at intervals of 12 to 48 months. Since the time period between the first and second radiograph could range between 12 to 48 months, changes in Ratingen score were to be normalized to 1 year.|||scores on a scale||Standard Deviation|Mean
1440728|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12||||drinks/drinking day||Standard Deviation|Mean
1440729|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12||||drinking days/week||Standard Deviation|Mean
1440730|NCT00929344|Primary|Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.|Baseline and Week 12||||drinks/week||Standard Deviation|Mean
1440731|NCT00929331|Secondary|Number of Subjects With Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From the beginning up to the end of the study (Day 0 - Day 21)||||subjects|||Number
1440732|NCT00929331|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any = unsolicited adverse event regardless of intensity. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination."|During a 21-day (Day 0-20) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
1440830|NCT00928668|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|5 days|The safety set included all patients who received any study medication.|||percentage of participants|||Number
1440733|NCT00929331|Secondary|Number of Subjects Reporting Related Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.~Related = general symptom assessed by the investigator as related to the vaccine"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
1440734|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.~Grade 3 general symptom = symptom that prevented normal activity Grade 3 temperature = temperature above 39.0 degrees celsius"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
1440735|NCT00929331|Primary|Number of Subjects With a Pre-vaccination Titer Below the Cut-off Value and a Post-vaccination Titer Equal to or Above the Cut-off Value|"The cut-off value was a titer of 1:40.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
1440736|NCT00929331|Primary|Seroconversion Factors|"Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||ratio||95% Confidence Interval|Mean
1440737|NCT00929331|Primary|Number of Seroconverted Subjects|"A seroconverted subject is a subject who had either a prevaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a four-fold increase in post-vaccination titer.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
1440738|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|"The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
1440739|NCT00929331|Primary|Number of Subjects With a Serum HI Titer Equal to or Above the Cut-off Value|"The cut-off value was defined as a serum HI titer >= 1:40, which is usually accepted as indicating protection.~Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane."|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||subjects|||Number
1440740|NCT00929331|Primary|GMTs of HI Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 21 after vaccination|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1440741|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|"Solicited local symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, temperature (orally) in degrees celsius.~Any = solicited general symptoms are presented regardless of their intensity grade or relationship to vaccination.~For temperature this means equal to or above 38.0 degrees celsius."|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
1440742|NCT00929331|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the site of injection.~Grade 3 pain = pain that prevented normal activity, Grade 3 redness/swelling = redness/swelling > 100 mm"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
1440743|NCT00929331|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|"Solicited local symptoms assessed include pain, redness and swelling at the site of injection.~Any = Solicited local symptoms are presented regardless of their intensity grade"|During a 4-day (Day 0-3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all subjects for whom data were available.|||subjects|||Number
1440831|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours|32 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
1440744|NCT00929331|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies|Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.|At Day 0|Analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. These included subjects for whom assay results were available for antibodies against at least on study vaccine antigen component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1440745|NCT00929305|Primary|Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.|baseline and one day||||units on a scale||Standard Deviation|Mean
1440746|NCT00929305|Secondary|Muscle Trigger Points of the Cervical Spine||one day|||||||
1440747|NCT00929305|Secondary|Range of Motion of the Neck and Shoulders||one day|||||||
1440748|NCT00929305|Primary|The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment|Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.|baseline and one day||||participants|||Number
1440749|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Initial Treatment Phase)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
1440750|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Initial Treatment Phase)|Objective Response was determined by the investigator using RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30% decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Pearson-Clopper one-sample method was used for CI.|Screening and at the end of every third cycle until randomization for an average of 18 weeks|Initial Phase ITT population; only participants who were not randomized at the end of the initial treatment phase were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
1440751|NCT00929240|Secondary|Quality of Life Assessed As Change From Baseline in Global Health Status Using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - 30 (EORTC QLQ - C30) (Maintenance Phase Data Cutoff October 4, 2013)|The EORTC QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. The change in global health status was determined to be the difference in values at baseline and each specific visit. The term ‘’baseline’’ refers to the time of randomization to the maintenance phase.|Baseline, Randomization and Cycles 3, 6, 9 and 12|Maintenance Phase ITT population; n (number) = number of participants analyzed at the specific visit. Only timepoints with more than 10 participants in each treatment arm are presented.|||units on a scale||95% Confidence Interval|Mean
1440752|NCT00929240|Secondary|Time To Progression (Maintenance Phase Data Cutoff October 4, 2013)|Time to Progression was defined as the time from randomization to the first documented disease progression (using investigator assessments of disease progression by RECIST 1.0). PD was defined as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population|||months||95% Confidence Interval|Median
1440753|NCT00929240|Secondary|Percentage Of Participants With PD or Death Due to PD (Maintenance Phase Data Cutoff October 4, 2013)|PD was defined per RECIST 1.0 as 20% increase in the sum of the longest diameter of target lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013|Maintenance Phase ITT population|||percentage of participants|||Number
1440754|NCT00929240|Secondary|Percentage of Participants Expected to Be Alive After 1 and 2 Years on Treatment (Maintenance Phase Data Cutoff October 4, 2013)|Probability of being alive after 1 and 2 years on treatment with 95% CIs was calculated using Kaplan Meier approach with LOGLOG transformation.|Years 1 and 2|Maintenance Phase ITT Population|||percentage of participants||95% Confidence Interval|Number
1440755|NCT00929240|Secondary|Overall Survival (Maintenance Phase Data Cutoff October 4, 2013)|Duration of Overall Survival (OS) was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. Kaplan Meier estimation was used to determine OS.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||months||95% Confidence Interval|Median
1440757|NCT00929240|Secondary|Percentage of Participants With Clinical Benefit (CR, PR and SD) Per RECIST 1.0 (Data Cutoff October 4, 2013)|CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as ≥ 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||percentage of participants||95% Confidence Interval|Number
1440758|NCT00929240|Secondary|Percentage of Participants With Best Overall Confirmed Objective Response of CR or PR Per RECIST 1.0 (Maintenance Phase Data Cutoff October 4, 2013)|Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. Progressive disease (PD) was defined as 20% increase in the sum of the longest diameter of target lesions and SD was defined as small changes that do not meet above criteria. Pearson-Clopper one-sample method was used for Confidence intervals (CIs).|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT Population|||percentage of participants||95% Confidence Interval|Number
1440759|NCT00929240|Primary|Progression Free Survival (Maintenance Phase Data Cutoff October 4, 2013)|PFS was defined as the time from first study drug dosing to the first documented disease progression or death, whichever occurred first.Time to progression was defined as the time from randomization to the first documented disease progression defined per RECIST 1.0 criteria. Participants without an event at data cut-off or who were withdrawn from the study without documented progression were censored at the date of the last tumor assessment when the participant was known to be progression free. Participants who took other non-protocol anti-cancer drugs while being on study medication, and who were still event free were censored on the date of first dose of the anti-cancer drug. Participants without post-randomization tumor assessments but alive were censored at the time of randomization. Participants without post-randomization assessments, who died after randomization were considered to have the PFS event at date of death. Kaplan-Meier estimation was used for median time to PFS|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population|||months||95% Confidence Interval|Median
1440760|NCT00929240|Primary|Percentage of Participants With Disease Progression or Death (Maintenance Phase Data Cutoff October 4, 2013)|Progression Free Survival (PFS) was defined as the time from first study drug dosing (during the maintenance treatment phase) to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST). Progressive Disease (PD) was defined as a 20 percent (%) or greater increase in the sum of the Longest Diameter (LD) of the target lesions taking as reference the smallest sum LD recorded or appearance of new lesions.|Randomization, at the end of every third cycle (every 9 weeks) until the end of maintenance phase and every 3 months until disease progression or death until data cutoff on October 4, 2013, up to 4 years|Maintenance Phase ITT population: All randomized participants|||percentage of participants|||Number
1440761|NCT00929201|Secondary|Peak Plasma Concentration (Cmax) of Metformin|Serum samples were used to determine the maximum concentration for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period|||ng/mL||Standard Deviation|Least Squares Mean
1440762|NCT00929201|Primary|Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin|Serum samples were used to determine the AUC from time 0 to infinity for metformin.|Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 32, 48, and 72 hours postdose|All participants who completed and who had pharmacokinetic data available from at least one treatment period|||μg * hr/mL||Standard Deviation|Least Squares Mean
1440763|NCT00929162|Secondary|Tumour Response Rate|Objective response rate defined as participants with a complete or partial response according to RECIST|While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)|The number of participants for analysis corresponds to patients with measurable disease at study entry|||Participants|||Number
1440764|NCT00929162|Secondary|Overall Survival|Median time (in months) from randomisation until death using the Kaplan-Meier method.|Patients were followed for survival up to 2 years|Overall Survival was not analysed as the study was terminated early.||||||
1440765|NCT00929162|Primary|Progression Free Survival|Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.|Patients were followed for progression up to 2 years||||Months||Inter-Quartile Range|Median
1440766|NCT00929110|Secondary|Change From Baseline in the Mean Daily Total Symptom Score During the Study (Baseline to Week 52)|The daily total symptom score was defined as the sum of the morning and evening patient self-reported diary assessments of 6 symptoms (respiratory symptoms/impact on daily activities, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Means for baseline (14 day maximum run-in period) and the 52 week treatment period were calculated. Mean scores ranged from 0-18, with a higher score indicating worse symptoms. A negative change score indicated improvement.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1440776|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post Dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440767|NCT00929110|Secondary|Percentage of “Days Able to Perform Usual Daily Activities” During the Study (Baseline to Week 52)|A “day able to perform usual daily activities” was defined as any day where the patient recorded in their electronic diary in the evening that they were not prevented from performing their usual daily activities due to respiratory symptoms during the previous 12 hours. The percentage of “days able to perform usual daily activities” was calculated as the total number of “days able to perform usual daily activities” over the 52 week treatment period divided by the total number of days where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of days||Standard Error|Least Squares Mean
1440768|NCT00929110|Secondary|Percentage of Days With “no Daytime Symptoms” During the Study (Baseline to Week 52)|A day with “no daytime symptoms” was defined as any day where the patient recorded no cough, no wheeze, no production of sputum, no feeling of breathlessness (other than when running), and no puffs of rescue medication during the previous 12 hours in evening entry in the electronic patient diary. The percentage of days with “no daytime symptoms” was calculated as the total number of days with “no daytime symptoms” over the 52 week treatment period divided by the total number of days where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of days||Standard Error|Least Squares Mean
1440769|NCT00929110|Secondary|Percentage of Nights With “no Nighttime Awakenings” During the Study (Baseline to Week 52)|A night with “no nighttime awakenings” was defined as any night where the patient did not wake up due to 1 or more of 6 symptoms (respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and breathlessness). Symptoms occurring during the previous 12 hours were recorded each morning and evening by the patient in an electronic diary. The percentage of nights with ‘no nighttime awakenings’ was calculated as the total number of nights with “no nighttime awakenings” over the 52 week treatment period divided by the total number of nights where diary recordings were made.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of nights||Standard Error|Least Squares Mean
1440770|NCT00929110|Secondary|Percentage of Patients Who Experienced a Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Percentage of participants|||Number
1440771|NCT00929110|Secondary|Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Per Year During the Study (Baseline to Week 52)|The number of moderate or severe exacerbations of COPD per year during the study was calculated by dividing the total number of exacerbations during the study by the total number of years of treatment. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Exacerbations per treatment year||95% Confidence Interval|Number
1440772|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes and From 12 Hours to 23 Hours 45 Minutes Post-dose at Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 23 hours 45 minutes post-dose at Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440773|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours Post-dose at Day 1 and Weeks 12 and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, 4, 6, 8 10, and 12 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 12 hours post-dose at Day 1 and Weeks 12 and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440774|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at Day 1 and Weeks 12, 26, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 3, and 4 hours post-dose. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included the same covariates as the primary Outcome Measure.|From 5 minutes to 4 hours post-dose at Day 1 and Weeks 12, 26, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440775|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; and 1, 2, 3, and 4 Hours Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; and 1, 2, 3, 4 hours post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440787|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Subject|Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100).|immediate post-injection||||units on a scale|Participants|Standard Deviation|Mean
1440777|NCT00929110|Secondary|Forced Vital Capacity (FVC) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440778|NCT00929110|Secondary|Forced Expiratory Volume in 1 Second (FEV1) 5, 15, and 30 Minutes; 1, 2, 3, 4, 6, 8, 10, and 12 Hours; 23 Hours 15 Minutes; and 23 Hours 45 Minutes Post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. The analysis included the same covariates as the primary Outcome Measure. Data was not collected at all time points for all Days and Weeks.|5, 15, and 30 minutes; 1, 2, 3, 4, 6, 8, 10, and 12 hours; 23 hours 15 minutes; and 23 hours 45 minutes post-dose at Days 1 and 15; and Weeks 5, 9, 12, 16, 20, 26, 34, 42, 50, and 52|Full Analysis Set (FAS), serial spirometry subgroup: A subgroup of approximately one third of all randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440779|NCT00929110|Secondary|Trough Forced Vital Capacity (FVC) at Day 1, Week 12, Week 26, and Week 52|Trough FVC is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FVC values. Just prior to FVC measurement, patients performed normal tidal breathing. The patient was given a few breaths warning before being told “At the end of the next normal breath out, take a deep breath all the way in”; they were then verbally encouraged to make a maximal effort before relaxing. The analysis included the same covariates as the primary Outcome Measure.|Day 1, Week 12, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440780|NCT00929110|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included the same covariates as the primary Outcome Measure.|Day 1, Week 26, and Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440781|NCT00929110|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The mean daily number of puffs of rescue medication taken was calculated by dividing the number of puffs of rescue medication per day over the 52 weeks of the study by the number of days with non-missing rescue medication data. Rescue medication data recorded during the 14 day run-in period was used to calculate the baseline. The analysis included the same covariates as the primary Outcome Measure. A positive change score indicates more puffs taken.|Baseline to Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Puffs||Standard Error|Least Squares Mean
1440782|NCT00929110|Secondary|Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)|Time to first moderate or severe COPD exacerbation was calculated as the number of days from baseline to the day on which the patient experienced the first moderate or severe COPD exacerbation. A COPD exacerbation was considered to be moderate if treatment with systemic corticosteroids and/or antibiotic was required. A COPD exacerbation was considered to be severe if treatment for moderate severity and hospitalization was required.|Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Days||Full Range|Median
1440783|NCT00929110|Secondary|Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52|The SGRQ contained 51 patient-rated items divided into three components: Symptoms (respiratory symptoms, their frequency, and severity), Activity (activities that cause or are limited by breathlessness), and Impacts (social functioning and psychological disturbances resulting from airway disease). A total score for the 3 components was calculated and ranged from 0 to 100. Higher values indicate greater impairment of QoL. The analysis included the same covariates as the primary Outcome Measure.|Week 52|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1440784|NCT00929110|Secondary|Transition Dyspnea Index (TDI) at Week 26|The TDI measured changes in dyspnea from baseline during treatment and included 3 domains: Functional impairment (activities of daily living), magnitude of task (intensity of activity), and magnitude of effort (difficulty breathing). Each domain was rated from -3 to 3 (major deterioration-major improvement). The total score ranged from -9 to 9; minus scores indicate deterioration. The analysis included the same covariates as the primary Outcome Measure.|Week 26|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
1440785|NCT00929110|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.|Week 12|Full Analysis Set (FAS): All randomized patients who received at least 1 dose of study medication.|||Liters||Standard Error|Least Squares Mean
1440786|NCT00929071|Primary|Assessment of Immediate Post-injection Pain Severity by Investigator|Investigators assessment of immediate post-injection pain severity using Thermometer Pain Scale (TPS) with a range of 0-10 where 0=no pain and 10=worst possible pain|immediate post injection||||units on a scale|Participants|Standard Deviation|Mean
1440790|NCT00928889|Secondary|Change From Baseline in Glycosylated Serum Albumin (GSA) at the End of the Study (Week 4)|Blood samples were collected for measurement of GSA prior to (fasting) the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. GSA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||Percentage||Standard Deviation|Mean
1440791|NCT00928889|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at the End of the Study (Week 4)|Blood samples were collected for measurement of hsCRP prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. hsCRP was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mg/dL||Standard Deviation|Mean
1440792|NCT00928889|Secondary|Change From Baseline in Free Fatty Acids (FFA) at the End of the Study (Week 4)|Blood samples were collected for measurement of FFA prior to (fasting) and 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. FFA was assayed at a central laboratory.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
1440793|NCT00928889|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of HDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. HDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
1440794|NCT00928889|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the End of the Study (Week 4)|Blood samples were collected for measurement of LDL-C prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. LDL-C was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
1440795|NCT00928889|Secondary|Change From Baseline in Triglycerides at the End of the Study (Week 4)|Blood samples were collected for measurement of triglycerides prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Triglycerides were assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
1440796|NCT00928889|Secondary|Change From Baseline in Total Cholesterol at the End of the Study (Week 4)|Blood samples were collected for measurement of total cholesterol prior to (fasting) and 120 minutes following the start of a standardized meal test at Baseline and Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM. Total cholesterol was assessed at each study site using the same method and same reference value.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
1440797|NCT00928889|Secondary|Change From Baseline in Postprandial Glucose Area Under the Curve at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The postprandial glucose area under the curve was calculated using values from the 4 time points. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol*min/L||Standard Deviation|Mean
1440798|NCT00928889|Secondary|Change From Baseline in Peak Postprandial Glucose at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. The peak postprandial glucose values were used in the calculation of change from Baseline at Week 4. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
1440832|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours|8 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
1440799|NCT00928889|Primary|Change From Baseline in Postprandial Glucose Excursion (PPGE) at the End of the Study (Week 4)|Blood samples were collected for measurement of plasma glucose at 30, 60, 90, and 120 minutes following the start of a standardized meal test at Baseline and Week 4. PPGE was defined as the mean difference between the preprandial glucose value and the postprandial glucose value measured at 2 hours in a standardized meal test. Participants were fasting (no calorie intake for at least 8 hours prior to the meal test) and completed the standardized meal test between 7 and 10 AM.|Baseline to the end of the study (Week 4)|Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable.|||mmol/L||Standard Deviation|Mean
1440800|NCT00928772|Secondary|Heart Rate During Cataract Surgery Under Topical Anesthesia||during cataract surgery up to 30 minutes||||Beats per minute||Full Range|Mean
1440801|NCT00928772|Secondary|Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia||during cataract surgery up to 30 minutes||||mmHg||Full Range|Mean
1440802|NCT00928772|Secondary|Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia|VAS from 0 to 10 with 10 being maximal discomfort percieved|during cataract surgery up to 30 minutes||||units on a scale||Full Range|Mean
1440803|NCT00928772|Primary|Anxiety During Cataract Surgery Under Topical Anesthesia|Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.|during the cataract surgery up to30 minutes||||units on a scale||Full Range|Mean
1440804|NCT00928746|Secondary|Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440805|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440806|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440807|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440808|NCT00928746|Secondary|Number of Participants Who Reported Satisfaction With Performance of the Dose Counter for Indicating Approximately How Many Doses Remain in Inhaler According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440809|NCT00928746|Secondary|Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440810|NCT00928746|Secondary|Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440811|NCT00928746|Secondary|Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||participants|||Number
1440812|NCT00928746|Secondary|Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||95% Confidence Interval|Median
1440813|NCT00928746|Secondary|Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations based on advancing the actuation indicator to a zero reading or to the next increment and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||95% Confidence Interval|Median
1440814|NCT00928746|Secondary|Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed|Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||95% Confidence Interval|Median
1440815|NCT00928746|Secondary|Actuations Registered by the Actuation Indicator and Read by Site Coordinator||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
1440816|NCT00928746|Secondary|Actuations Based on Advancing the Actuation Indicator|Actuations based on advancing the actuation indicator to a zero reading or to the next increment|21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
1440817|NCT00928746|Secondary|Actuations Recorded on Patient Diary||21 Days|This secondary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
1440818|NCT00928746|Primary|Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed|Difference between the number of actuations registered by the actuation indicator and the number of actuations dispensed (calculated using weight differential and shot weight)|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)|||Count||95% Confidence Interval|Median
1440819|NCT00928746|Primary|Actuations Dispensed|Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight|21 Days|The primary analysis was performed using the Full Analysis Set (FAS)|||Count||Standard Deviation|Median
1440820|NCT00928746|Primary|Actuations Registered by the Actuation Indicator|This outcome measure presents the number of actuations (doses) of medication used in the specific time frame as measured by the actuation indicator|21 Days|The primary analysis was performed using the Full Analysis Set (FAS).|||Count||Standard Deviation|Median
1440821|NCT00928720|Secondary|Functional Status Using the Fibromyalgia Index Questionnaire||Week 8||||units on a scale||Standard Deviation|Mean
1440822|NCT00928720|Secondary|Perceived Stress Using Numeric Rating Scale||Week 8||||units on a scale||Standard Deviation|Mean
1440833|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours|4 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
1440834|NCT00928668|Secondary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes|30 minutes post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
1440835|NCT00928668|Primary|Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours|Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours|24 hours post dose|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.|||Log base 2 (mg/ml)||Standard Error|Least Squares Mean
1440836|NCT00928642|Secondary|To Assess the Effects of Prognostic Variables; Initial Performance Status; Platinum Sensitivity, and Mucinous (or Clear Cell)Histology on Progression-free Survival Overall.|The study was stopped after 8 subjects. It was not possible to perform meaningful analysis on prognostic variables. this outcome measure was not done.|Until disease progression|||||||
1440837|NCT00928642|Secondary|To Estimate the Clinical Response Rate(Partial and Complete Response as Defined Under the SWOG Criterial)|"Using SWOG criteria for response of measurable disease, subject best response was assessed. First assessment was 6 weeks after starting treatment. Subjequent evaluations were every 6 weeks in patients who remained on study.~Repsonse rate was the sum of Complete Repsonse and Partial Response."|until disease progression or unacceptable toxicity|All subjects were assessed after 6 weeks of treatment and reassessed at 6 week intervals|||participants|||Number
1440838|NCT00928642|Secondary|To Determine the Distribution of the Overall Survival|All subjects were followed after treatment was complete to assess overall survival.|Until death||||months||Full Range|Median
1440839|NCT00928642|Secondary|Tumor Response Rates Using Modified SWOG Criteria to the Combination of Gleevec and Gemzar in Patients With Relapsed Ovarian Cancer Who Have Failed at Least One Prior Chemotherapy Treatment.|"Best response to thearpy was assessed using modified SWOG criteria (same as for outcome masure #1). Subjects were assess as complete response, partial response, stable disease, and progressive disease after 2 cycles (6 weeks) of beginning treatment and every 6 weeks afterward until progression of disease, unacceptable toxicity, or subject withdrawl from study.~the measurement reported is the number of patients who met the criteria for partial response."|Subjects treated until progression of disease or unacceptable toxicity. no maximum dose was specified|All subjects who underwent treatment and participated in the study were analysed|||participants|||Number
1440840|NCT00928642|Primary|To Determine the Safety and Tolerability Via Frequency and Severity of Adverse Effect of Combination Gleevec and Gemzar in This Cohort of Patients as Assessed Byt Common Toxicity Criteria|Toxicity was assess prior to each cycle of therapy (every 3 weeks) and graded based on NCI common toxicity criteria|Until disease progression or unacceptable toxicity||||participants|||Number
1440841|NCT00928642|Primary|The Cystostatic, Anti-tumor Activity of the Combination of Gleevec and Gemzar Via Progression-free Survival for at Least Six Months in Patients With Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma.|Progression free survival at six months was assessed for all research subjects. Progression defined by SWOG criteria: Invest New Drugs. 1992 Nov;10(4):239-53. Progression is defined as > 50% increase in the sume of measured cross sectional area of areasa of measurable disease, measured from the lowest measured amount of disease. Progression is also defined as new areas of measurabe disease.|Time to progression was measured from enrollment in study until documented disease progression over a period not greater than 2 years.|of 8 enrolled subjects, 7 were eligible for analysis of progression-free survival at 8 months. One subject declined to continue treatment|||participants|||Number
1440842|NCT00928512|Secondary|Change From Baseline in ACR Component: Erythrocyte Sedimentation Rate (ESR) at Week 16|Blood for ESR, which is helpful to diagnose inflammatory diseases and to monitor disease activity and response to therapy, was obtained at the visits.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||mm/hr||Standard Error|Least Squares Mean
1440843|NCT00928512|Secondary|Change From Baseline in ACR Component: High Sensitivity C-reactive Protein (hsCRP)|Blood for this assessment was obtained at the visits in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.Since the results of this test may have unblinded study personnel, results from the central lab were provided for screening and baseline only. The hsCRP results from samples collected during the treatment period were revealed only after final database lock.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||mg/L||Standard Error|Least Squares Mean
1440851|NCT00928512|Secondary|Anti-CCP (Cyclic Citrulinated Peptide) Antibodies Concentrations at Baseline and at Week 16|Only values that were above normal range (20 units) were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Units||Standard Deviation|Mean
1440894|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 6|Baseline is pre-cinacalcet.|Month 6|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1440844|NCT00928512|Secondary|Change From Baseline in ACR Component: Health Assessment Questionnaire (HAQ©) Score at Week 16|HAQ© was used to assess physical ability and functional status of patients as well as quality of life at the visits in these 8 categories assessed by the Disability Index: dressing & grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Patients report amount of difficulty they have in performing 2 or 3 specific activities. There are 4 possible responses (0, 1, 2, 3) for these questions which include types of assistance, if any; the participant uses for his/her usual activities: 0: without any difficulty- No assistance is needed; 1: with some difficulty - A special device is used by the patient in his/her usual activities; 2: with much difficulty - The patient usually needs help from another person. 3: Unable to do - the patient usually needs both a special device and help from another person. Scores of 0 - 1 are generally considered to represent mild to moderate difficulty, 1-2 moderate to severe disability, and 2 -3 severe to very severe disability.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale||Standard Error|Least Squares Mean
1440845|NCT00928512|Secondary|Change From Baseline in ACR Component: Physician’s Global Assessment of Disease Activity at Week 16|"The physician’s global assessment of disease activity was performed at the visits usingon a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||VAS in mm||Standard Error|Least Squares Mean
1440846|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Global Assessment of Disease Activity at Week 16|"The patient’s global assessment of disease activity was performed at the visits on a 100 mm non-anchored visual analog scale, from no arthritis (0) activity to maximal arthritis (100) activity, after the question, Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||VAS in mm||Standard Error|Least Squares Mean
1440847|NCT00928512|Secondary|Change From Baseline in ACR Component: Patient's Assessment of RA Pain at Week 16|"The patient's assessment of pain was performed at all visits using 100 mm visual analog scale (VAS) ranging from no pain to unbearable pain after the question Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours."|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||VAS in mm||Standard Error|Least Squares Mean
1440848|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Tender 28-joint Count at Week 16|The ACR tender joint count (28 joints) was done by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., T) was less than 28, the number of tender joints (e.g., t) was scaled up proportionately (i.e., 28*(t/T)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||tender joints||Standard Error|Least Squares Mean
1440849|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using ESR (DAS28-ESR) at Week 16|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient’s ‘global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission.The DAS28 was also derived using erythrocyte sedimentation rate (ESR) (referred to as DAS28-ESR).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale||Standard Error|Least Squares Mean
1440850|NCT00928512|Secondary|Change From Baseline in ACR Component: Adjusted Swollen 28-joint Count at Week 16|Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive result for swollen joint count. Joint counts were performed according to the visit schedule by the physician or by well trained personnel. Whenever possible, the same evaluator performed these assessments at all visits. The following 28 joints were assessed for tenderness and swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). If the number of joints for which data were available (e.g., S) was less than 28, the number of swollen joints (e.g., s) was scaled up proportionately (i.e., 28*(s/S)).|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||swollen joints||Standard Error|Least Squares Mean
1440852|NCT00928512|Secondary|Change From Baseline in Rheumatoid Factor (RF) Concentrations at Week 16|Only values that were above normal range (12 U/mL) were were included.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||U/mL||Standard Deviation|Mean
1440853|NCT00928512|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 16|The distribution of EULAR response criteria was according to DAS28-CRP at Week 16. EULAR response criteria are based on DAS28-CRP status in combination with DAS28-CRP improvements. The EULAR response criteria are as follows: Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement >1.2 corresponds to 'good response'; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement between 0.6 to 1.2, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement >1.2 or from 0.6 to 1.2, or WeeK 16 DAS28-CRP >5.1 with DAS28-CRP improvement >1.2 correspond to 'moderate response; Week 16 DAS28-CRP <3.2 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP between 3.2 to 5.1 with DAS28-CRP improvement <0.6, or Week 16 DAS28-CRP >5.1 with DAS28-CRP improvement between 0.6 to 1.2 or <0.6 correspond to 'no response'.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Percentage of participants|||Number
1440854|NCT00928512|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 16|The Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue©) is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants responded to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeThe scale score was computed by summing the item scores, after reversing those items that were worded in the negative direction. When there were missing item scores, the subscale score was computed by summing the non-missing item scores, multiplying by 13 (the total number of items in the scale) and dividing by the number of non-missing items. The latter rule applied only when at least half of the items (seven or more) were non-missing. FACIT-Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.|Baseline, Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale-change from baseline||Standard Deviation|Mean
1440855|NCT00928512|Secondary|Change From Baseline in Medical Outcome Short Form (36) Health Survey (SF-36® v2)|The SF-36 Scale is a 36-item, patient-reported survey which measures overall quality of life. It consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health) which can be aggregated to derive a physical-component summary score and a mental-component score. Scores are normally determined with the use of norm-based methods which standardize scores based on an assessment of the general U.S. population free of chronic conditions. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with the higher scores indicative of better health.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale-change from baseline||Standard Deviation|Mean
1440856|NCT00928512|Secondary|Change From Baseline in Disease Activity Score 28 Using CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in Rheumatoid Arthritis (RA). The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR) or hsCRP, and the patient’s ‘global assessment of global health (indicated by marking a 100 mm line between very good and very bad). A DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease, and less than 2.6 remission. The DAS28-CRP was derived from swollen joint count, tender joint count, hsCRP and patient’s global assessment of disease activity.|Baseline, week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||scores on a scale||Standard Error|Least Squares Mean
1440857|NCT00928512|Secondary|Number of Participants Who Achieved an ACR20, ACR50 or ACR70 Response up to Week 16|A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if he/she had as least a 20%, 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assessed disability and acute phase rectant or Erythrocyte sedimentation rate (ESR).|at Weeks2, 4, 8, 12, 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Participants|||Number
1440866|NCT00928434|Secondary|Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group|The time to testosterone >0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Days||95% Confidence Interval|Median
1440895|NCT00928408|Primary|Achievement of a Reduction From Baseline of Albumin-corrected Serum Calcium ≥ 0.25 mmol/L (1 mg/dL) at Month 3|Baseline is pre-cinacalcet.|Month 3|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1440858|NCT00928512|Secondary|Number of Participants Who Achieved an ACR50 or ACR70 Response at Week 16|A participant was considered as improved according to the ACR50 or ACR70 criteria if he/she had at least a 50% or 70% improvement, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient self-assessed disability (Health Assessment Questionnaire [HAQ©] score) and Acute phase reactant (C-reactive protein [hsCRP]/ESR). Participants were defined as ACR50/70 responders at a given post-randomization visit if they satisfied the ACR50/70 criteria, respectively. Participants were considered ACR50/70 nonresponders if they failed the ACR50/70 criteria respectively. Participants who prematurely discontinued from study due to insufficient therapeutic effect were also considered nonresponders.|Week 16|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Participants|||Number
1440859|NCT00928512|Primary|Number of Participants With American College of Rheumatology Response of 20 (ACR20) at 16 Weeks|A participant was considered to have achieved the incidence of response (ACR20 criteria) if he/she had at least a 20% improvement in both the tender and swollen 28-joint counts and had at least 20% improvement in at least 3 of the following 5 measures: patient's assessment of rheumatoid athritis (RA) pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's self-assesseddisability (Health Assessment Questionnaire [HAQ©] score)and acute phase rectant (C-reactive protein [hsCRP]/ESR).|16cweeks|Full analysis set (FAS) all subjects to whom study drug was assigned. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization. FAS did not include subjects who have missing values for all post-baseline (visit >=3) assessments on all of the specified efficacy variables.|||Participants|||Number
1440860|NCT00928486|Secondary|Kaplan-Meier Estimates of Duration of Response (DoR)|Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia >11.5mg/dL|From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders|||weeks||95% Confidence Interval|Median
1440861|NCT00928486|Secondary|Myeloma Response Rate|Overall myeloma response rate was determined by the investigator using the Myeloma Response Determination Criteria adapted from Bladé criteria. A responder is any patient who showed at least a partial response. Overall myeloma response rate is defined as the percentage of participants who achieved a Complete Response (CR), plus a Remission Response (RR), plus a Partial Response (PR). A CR is the disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks. RR is a 75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. PR is a 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion.|From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks|Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria|||percentage of participants|||Number
1440862|NCT00928486|Primary|Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)|A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks|Safety population included all 25 participants who received at least one dose of study drug.|||participants|||Number
1440863|NCT00928434|Secondary|Percent Change From Baseline in Serum Testosterone Levels|Percent change from Baseline in serum testosterone levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percent change||Standard Deviation|Mean
1440864|NCT00928434|Secondary|Absolute Change From Baseline in Serum Testosterone Levels|Absolute Change From Baseline in Serum Testosterone Levels was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||ng/mL||Standard Deviation|Mean
1440865|NCT00928434|Secondary|Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level|The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).|During Phase B|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Days||95% Confidence Interval|Median
1440884|NCT00928408|Primary|Reason for Prescribing Cinacalcet||Initiation|Full Analysis Set|||Participants|||Number
1440896|NCT00928408|Primary|Duration of Exposure to Cinacalcet|Time from first dose to last non-zero dose on study|12 months|Full Analysis Set|||Days||Inter-Quartile Range|Median
1440867|NCT00928434|Secondary|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL|Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.|At 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percentage of patients||95% Confidence Interval|Number
1440868|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score|The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440869|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440870|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440871|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440872|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the SFI: Erection|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440873|NCT00928434|Secondary|Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive|"The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function.~Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440874|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score|The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440897|NCT00928408|Primary|Occurrence of a Change in Cinacalcet Dose or Frequency >6 Months After Initiation||>6 months after initiation|Full Analysis Set - Participants with Observed Data|||Participants|||Number
1440875|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440876|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440877|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440878|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440879|NCT00928434|Secondary|Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy–Prostate (FACT-P) : Physical Well-being|"The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score.~Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL."|During 14 months|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Scores on a scale||95% Confidence Interval|Mean
1440880|NCT00928434|Secondary|Percent Change From Baseline in Serum PSA Levels|Percent change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B analysis set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percent change||Standard Deviation|Mean
1440881|NCT00928434|Secondary|Absolute Change From Baseline in Serum PSA Levels|Absolute change from Baseline in serum PSA levels during the study period was measured.|Phase A Visit 1-8 and Phase B Visit 9-15.|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||ng/mL||Standard Deviation|Mean
1440882|NCT00928434|Primary|Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL|Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.|At 14 month|Analysis set consist of Full Phase B Analysis Set, which comprised of patients who completed 7 months of treatment and had a PSA ≤2.0 ng/mL at the end of Month 7 and had at least one primary endpoint efficacy assessment after Month 7.|||Percentage of patients||95% Confidence Interval|Number
1440883|NCT00928421|Primary|Responders to Treatment, Assessed by Duplex Ultrasound|Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.|8 weeks||||participants|||Number
1440913|NCT00928395|Primary|"Proportion of Patients Reporting Moderately or Markedly Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline"|The GRA asked patients, “Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?” and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).|36 months total||||Proportion of Patients||95% Confidence Interval|Number
1440914|NCT00928304|Secondary|Consistency Between Visual and Quantitative Efficacy|For a comparison of the results of the visual assessment with the quantitative assessment, descriptive Standardized Uptake Value Ratio (SUVR) statistics were computed separately for DS subjects with an abnormal/normal majority read of the PET scan (DS-PET+/DS-PET-). The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min||||SUVR||Standard Deviation|Mean
1440915|NCT00928304|Secondary|Quantitative Parameters Standard Uptake Value Ratio|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, posterior cingulate, lateral temporal cortex, parietal cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.|100 - 120 min p.i.|All Down Syndrome subjects and healthy volunteers enrolled in the study were included in this analysis|||SUVR||Standard Deviation|Mean
1440916|NCT00928304|Secondary|Sensitivity Results in the Down Syndrome Age Subgroups|The majority read sensitivity (percentage of DS subjects positive for cerebral beta-amyloid by majority read) was computed for the group of DS subjects with age equal to or below the median age (DS-young) and for DS subjects with age above the median age (DS-old). The median age was 46 yrs, with 3 subjects being exactly 46 yrs old. As defined, these subjects were assigned to the DS-young group.|100 - 120 min|All Down Syndrome subjects (n=39) were analyzed for this outcome.|||percentage of subjects||95% Confidence Interval|Number
1440917|NCT00928304|Primary|Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome|The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.|100-120 min|All subjects in the down syndrome population and healthy volunteers were included in this analysis.|||percentage of subjects||95% Confidence Interval|Number
1440918|NCT00928252|Primary|Proportional Hazards Regression Analysis of Time to PSA Progression|PSA levels measured from the start of treatment over the period of follow-up were recorded. Time to PSA progression was calculated as the number of days from the start of treatment to the date of the first PSA test result that represented a 30% or greater increase from the PSA nadir, confirmed on the basis of repeated PSA measurements. For proportional hazards regression analysis, the percentage change in PSA level within 15 wk of starting treatment was calculated, using a 50% or greater decrease in PSA level as a predefined definition of PSA re- sponse based on Prostate Cancer Working Group guidelines.|Up to 15 week post-chemotherapy|Twenty patients met the study criteria for an metabolically active tumor volume (MATV) response (30% or greater decline in MATV) response.|||Hazard Ratio||95% Confidence Interval|Number
1440919|NCT00928252|Primary|Time to PSA Progression|Time to PSA Progression between patients exhibiting MATV reduction greater or equal to 30% vs. MATV reduction less than 30%.|2 years||||days||Standard Error|Mean
1440920|NCT00928252|Primary|Metabolically Active Tumor Volume (MATV) Response|Number of patients achieving 30% or greater reduction in MATV measured on 18F-fluorocholine PET/CT|21 to 98 days||||Participants|||Count of Participants
1440921|NCT00928187|Secondary|Number of Patients With HIV Plasma Viral Load < 200 Copies/ml|number of patients having a plasma viral load below 200 copies/ml at week 24|Week 24|ITT|||Participants|||Count of Participants
1440922|NCT00928187|Secondary|Number of Patients With HIV Plasma Viral Load < 50 Copies/ml|Snapshot of patients with HIV viral load less then 50 copies/ml at week 24|Week 24|ITT|||Participants|||Count of Participants
1440923|NCT00928187|Secondary|Development of Metabolic Syndrome|number of patients developing metabolic syndrome over a period of 48 weeks|from baseline to week 48|population with data available|||Participants|||Count of Participants
1440924|NCT00928187|Secondary|Number of Patients With Resistance Mutations|number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml)|between W12 and W48|patients who failed second line (2 HIV RNA measure above 1000 copies/ml)|||participants|||Number
1440925|NCT00928187|Secondary|Adherence|number of patients in different categories of adherence as measured by questionnaire|between baseline and W48|patients with data available|||participants|||Number
1440926|NCT00928187|Secondary|Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)|evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value|between baseline and W48|ITT|||participants|||Number
1440927|NCT00928187|Secondary|Tolerance: Neuropathies (Grade 1 to 4)|any symptom of peripheral neuropathy|between baseline and W48|ITT|||participants|||Number
1440928|NCT00928187|Secondary|Tolerance: Gastrointestinal Complains|Gastrointestinal complaints (grade 1 to 4) between baseline and W48.|between baseline and 48 weeks|ITT|||participants|||Number
1440929|NCT00928187|Secondary|Number of Patients Discontinuing Study Treatment|number of patients discounting treatment because of adverse events|between baseline and W48|ITT|||participants|||Number
1440930|NCT00928187|Secondary|Gain in CD4 Cells Between Baseline and W48|median gain in circulating CD4 cells between baseline and W48|between baseline and 48 weeks|ITT with data available|||cell/mm3||Inter-Quartile Range|Median
1440931|NCT00928187|Secondary|Patients With Plasma HIV RNA < 200 Copies/ml|number of patients with plasma HIV RNA below 200 copies/ml|48 weeks|ITT|||participants|||Number
1440934|NCT00928174|Primary|Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT|The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.|Concurrent with PET Procedure|Outcome Measure Data Table reflects data from the 22 subjects completing the current study.|||%PET-positive cases in a given PSA range|||Number
1440935|NCT00928083|Secondary|OZ439 Rac|"Accumulation index is the ratio of drug exposure observed during a dosing interval at steady-state divided by drug exposure after a single first dose, as described by the following equations:~Accumulation index (Rac) = AUC0-(Day 3)/ AUC0-(Day 1)"|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population received multiple dosing only. This PK parameter is not applicable in a single dose setting.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1440936|NCT00928083|Secondary|OZ439 t1/2|Apparent terminal half-life (t1/2)|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||hours||Geometric Coefficient of Variation|Geometric Mean
1440937|NCT00928083|Secondary|OZ439 Tmax|Time to maximum observed plasma drug concentration of OZ439|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||hours||Full Range|Median
1440938|NCT00928083|Secondary|OZ439 Cmax|Maximum observed plasma drug concentration (Cmax).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1440939|NCT00928083|Secondary|OZ439 AUC0-∝|Area under the plasma concentration-time curve from zero to infinity (AUC0-∝).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
1440940|NCT00928083|Secondary|OZ439 AUC0-t|Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t).|Samples collected from Pre-dose up to 96h post dose|Pharmacokinetics Population|||ng.h/ml||Geometric Coefficient of Variation|Geometric Mean
1440941|NCT00928083|Primary|Adverse Events|Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.|From screening and at 10 (+/-2) days after last dose of study medication||||participants|||Number
1440942|NCT00928070|Secondary|Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12|PVR volume is defined as volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||mL||Standard Deviation|Mean
1440943|NCT00928070|Secondary|Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline|Screening, Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1440944|NCT00928070|Secondary|Mini Mental State Examination (MMSE)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.|Screening|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1440945|NCT00928070|Secondary|Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response|"Participant's response to question, overall, how satisfied are you with your OAB medication? was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into satisfied, and 4 and 5 were combined into dissatisfied."|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.|||percentage of participants|||Number
1440946|NCT00928070|Secondary|Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control|OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.|Week 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing value at Week 12.|||units on a scale||Standard Deviation|Mean
1440955|NCT00928070|Secondary|Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1440980|NCT00928018|Primary|To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil||2 years||||percentage of participants||95% Confidence Interval|Number
1440947|NCT00928070|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4, 12|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. LOCF method was used to impute Week 12 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.|||units on a scale||Standard Error|Least Squares Mean
1440948|NCT00928070|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Week 4 and 12.|||units on a scale||Standard Deviation|Mean
1440949|NCT00928070|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.|||units on a scale||Standard Error|Least Squares Mean
1440950|NCT00928070|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at both Weeks 4 and 12.|||units on a scale||Standard Deviation|Mean
1440951|NCT00928070|Secondary|Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12|PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.|Screening, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||percentage of participants|||Number
1440952|NCT00928070|Secondary|Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12|Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'n' is signifying those participants of the population subsets who were evaluated for this measure at the time point for each group respectively.|||undergarments||Standard Deviation|Mean
1440953|NCT00928070|Secondary|Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1440954|NCT00928070|Secondary|Frequency-Urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, 'N' (number of participants analyzed) signifies those participants who had baseline frequency urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1440956|NCT00928070|Secondary|Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
1440957|NCT00928070|Secondary|Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours|Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
1440958|NCT00928070|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1440959|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
1440960|NCT00928070|Secondary|Mean Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
1440961|NCT00928070|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1440962|NCT00928070|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Error|Least Squares Mean
1440963|NCT00928070|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Deviation|Mean
1440964|NCT00928070|Secondary|Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4, 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1440975|NCT00928018|Secondary|To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied.||2 years|Given the small number of patients within each group, we considered indolent histologies (indolent B-cell NHL, CLL and HL) together in one group (indolent group), and aggressive histologies (aggressive B-cell NHL, MCL, and T-cell NHL) in another (aggressive group).|||percentage of participants|||Number
1440965|NCT00928070|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.|||episodes per 24 hours||Standard Error|Least Squares Mean
1440966|NCT00928070|Primary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute only Week 12 missing data but not Week 4 missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
1440967|NCT00928070|Primary|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|Full analysis set (FAS) population included all participants who received at least 1 dose of study drug and had at least 1 baseline or post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
1440968|NCT00928057|Other Pre-specified|Reported Injection Site Leakage Events, by Pen Needle Type and Droplet Size|If insulin leakage from the injection site was observed, subjects rated the size of the leakage droplet based on a visual scale provided in their diaries. Scores of 1+, 2+, 3+, and 4+ correspond to droplet sizes of 1, 10, 20 and 50 ul, respectively. Droplets larger than those shown on the scale were scored as 5+. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks|The number of participants shown is the number of subjects that reported at least one event of leakage (see previous data table). The number of reported leakage events is presented for each droplet size category. No data were collected if there was no leakage.|||number of events|||Number
1440969|NCT00928057|Secondary|Relative Injection Pain Score Assessed by Subject|After using the second assigned pen needle (PN) for 3 weeks, subjects used a 150mm Visual Analog Scale (VAS) to rate the pain of the second PN relative to the first PN. The VAS was anchored at the center (0mm) with “as painful”, and at the extreme ends with “much less painful” (-75mm) and “much more painful” (+75mm). VAS scores were adjusted for the order of PN use, such that a positive score means that the 4mm PN was scored as more painful than the reference PN (5mm or 8mm), and a negative score indicates that the 4mm PN was less painful than the reference.|Visit 4: 18-24 days after starting 2nd pen needle|Of the 167 subjects that completed the study, 137 subjects had within-window VAS pain scores for Visit 4 and were included in this analysis. Per the protocol, the allowable visit window was 18-24 days from Visit 3, when the subject switched from the 1st to 2nd assigned pen needle.|||mm||Standard Error|Mean
1440970|NCT00928057|Other Pre-specified|Percentage of Subjects With at Least One Leakage Event|After each insulin injection with a study pen needle, subjects recorded in their study diary if they observed insulin leakage from the injection site. Subjects were not required to make a diary entry if there was no leakage.|each PN was used for 3 weeks||||percent of subjects|||Number
1440971|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hyperglycemic Events|Severe Unexplained Hyperglycemia is defined as requiring a visit to the emergency room or hospitalization and/or having a blood glucose value above 450mg/dL without an identified cause (for example, the subject missed an insulin dose). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.|||participants|||Number
1440972|NCT00928057|Secondary|Number of Subjects With Severe Unexplained Hypoglycemic Events|Severe Unexplained Hypoglycemia is defined as an event in which the subject’s blood glucose is below 50 milligrams per deciliter (mg/dL) and/or they required assistance from another person for treatment and there is no identified cause (for example, the subject skipped a meal). These events were also reported as Adverse Events.|During 3 weeks using each pen needle|All subjects that were randomized and used at least one of the study pen needles are included. The number of subjects with one or more events while using each PN is presented.|||participants|||Number
1440973|NCT00928057|Secondary|Percent Absolute Change in Fructosamine, by Dose Group|"Glycemic control was determined separately for each insulin dose group in the same manner as described for the primary outcome measure, according to the following formula:~%|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|"4 of the 167 completed subjects were excluded for out of window fructosamine samples (3), or lab error with a sample (1).~For 4 mm/8 mm: this includes 45 subjects in the Low Dose insulin group and 35 in the Regular Dose group. For 4 mm/5 mm: this includes 47 subjects in the Low Dose insulin group and 36 in the Regular Dose group."|||Percent absolute change||95% Confidence Interval|Mean
1440974|NCT00928057|Primary|Percent (%) Absolute Change in Fructosamine|"Within each study arm (4mm / 5mm PN, or 4mm / 8mm PN) subjects used one pen needle (PN) for 3 weeks then switched to the alternate PN for the next three weeks, for a total of 6 weeks. The principal endpoint measure of glycemic control is the percent absolute change in serum fructosamine concentration, based on the fructosamine (FRU) concentration measured in micromoles per liter (umol/L) at the end of each three week period. The change was calculated according to the following formula:~Percent absolute change in FRU, or %|∆ FRU|= 100*[FRU(4mm)-FRU(5 or 8mm)]/[FRU(5 or 8mm)]."|3 weeks per pen needle, from visit 2-3 and visit 3-4.|167 subjects completed the study. 163 of the 167 completed subjects were included in this analysis. Four (4) of 167 were excluded due to out of window fructosamine samples (3), or laboratory error with fructosamine sample (1).|||Percent absolute change||95% Confidence Interval|Mean
1440981|NCT00927992|Secondary|Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation||Post liver transplantation up to Month 3|Data was not analyzed as only hemophiliac participants were enrolled in the study.||||||
1440982|NCT00927992|Secondary|Dose of Exogenous Clotting Factors Used During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.|||International Unit/kilogram (IU/kg)||Standard Deviation|Mean
1440983|NCT00927992|Secondary|Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation|Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.|Up to Day 5 post liver transplantation|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
1440984|NCT00927992|Primary|Number of Participants Who Survived After Liver Transplantation|Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
1440985|NCT00927992|Primary|Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation|Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
1440986|NCT00927992|Primary|Number of Participants With Acute Rejection of Liver Transplant|Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
1440987|NCT00927992|Primary|Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation|Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.|Post liver transplantation up to Month 3|Evaluable population included all the participants who met the eligibility criteria.|||Participants|||Number
1440988|NCT00927953|Secondary|Time to a >= 1 Point Reduction in the Modified Rankin Scale Score||Study Day 2, 7, 14, 28, and 120|Intention to treat (ITT)|||Days||95% Confidence Interval|Median
1440989|NCT00927953|Secondary|Mean Modified Rankin Scale Scores|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead."|Study Day 0, 2, 7, 14, 28, and 120||||units on a scale||Standard Deviation|Mean
1440990|NCT00927953|Secondary|The Number of Participants With a Favorable Neurologic Outcome|"Favorable neurologic outcome responders are defined as subjects whose Modified Rankin Score is <=2. The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead."|Study Day 2, 7, 14, 28, and 120||||participants|||Number
1440991|NCT00927953|Primary|The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event|Includes adverse events considered possibly, probably, or definitely related to study drug|120 days|Intention to treat (ITT)|||participants|||Number
1440992|NCT00927953|Primary|The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)|"The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows:~0 = No symptoms at all~1 = No significant disability despite symptoms;~2 = Slight disability;~3 = Moderate disability;~4 = Moderately severe disability;~5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention;~6 = Dead"|Study Day 2, 7, 14, 28, and 120|All randomized participants with confirmed West Nile virus infection|||participants|||Number
1440993|NCT00927940|Secondary|Rates of Incomplete Stent Apposition, Neointimal Hyperplastic Volume and Percent Volume Obstruction (%VO)||8 months|||||||
1440994|NCT00927940|Secondary|Success(Device, Lesion, Procedure), Major Adverse Cardiac Events (MACE), Target Vessel Failure (TVF), and Stent Thrombosis||12 months|||||||
1440995|NCT00927940|Secondary|Percent of Patient With Target Lesion Failure(Major Secondary Endpoint)|Major Secondary Endpoint Target lesion fature (TLF) is defined as cardiac death, target vessel myocardial infarction(Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.|12 months|ITT population|||percentage of participants with TLF|||Number
1440996|NCT00927940|Primary|In-stent Late Lumen Loss (LLL)|The difference between the post-procedure immediate minimal lumen diameter (MLD) and follow up angigraphy MLD|Post procedure, 8 Months|Actually a patient was excluded from this analysis because of death before 30 days follow up.|||mm||Standard Deviation|Mean
1440997|NCT00927927|Secondary|Area Under the Concentration-time Curve (AUC)|Systemic exposure to NNC0142-0002.|Data were collected from 0 hours to at least Day 43 (SD cohorts) and Day 85 (MD cohorts), and until the receptor occupancy was confirmed below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo. Serum drug concentrations after dosing with less than 0.175 mg/kg (SD cohorts) and 0.3 mg/kg (MD cohorts) were below the lower limit of quantification.|||microgram×h/mL||Geometric Coefficient of Variation|Geometric Mean
1440998|NCT00927927|Primary|Frequency of Adverse Events|Adverse event: any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. Serious AE: AE that at any dose level resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly or birth defect, or an important medical event that may jeopardize the subject and require medical or surgical intervention.|Adverse events were collected for a mean (min; max) of 15.7 (6.4; 42.6) weeks for single-dose subjects, and 30.6 (12.7; 43.1) for multiple-dose subjects. Visits were scheduled until receptor occupancy was below the cut-off level for receptor positivity.|All randomised subjects exposed to at least one dose of NNC0142-0002 or placebo.|||events|||Number
1440999|NCT00927901|Secondary|Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1441000|NCT00927901|Secondary|Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period|Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.|End of each treatment period (Day 7)|Pharmacokinetic analysis set: All subjects with evaluable pharmacokinetic parameter data. Number of subjects varied due to missing values.|||pg * hr/mL||Geometric Coefficient of Variation|Geometric Mean
1441001|NCT00927901|Secondary|Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period|Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs > 0) was included to calculate endpoint.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Percentage of participants|||Number
1441002|NCT00927901|Secondary|Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7|FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.|Day 1 and Day 7|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Hours||90% Confidence Interval|Median
1441003|NCT00927901|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.|Baseline to Day 1|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||90% Confidence Interval|Least Squares Mean
1441004|NCT00927901|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.|Baseline to the end of each treatment period (Day 7)|Efficacy analysis set: All randomized subjects that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.|||Liters||90% Confidence Interval|Least Squares Mean
1441005|NCT00927888|Secondary|SNOT-20 Surgical Outcome Score|"This measures uses a 20 item surgical assessment tool to assess surgical field. This assessment score is the Sino-Nasal Outcome Test, SNOT-20. Patients were completed this validated sinus symptom questionnaire. The average magnitude score for the 20 items is calculated. Each item of the 20-question assessment is scored from 1 to 5 where 1 is less severe and 5 is a maximum as described by that particular symptom score. The final score is reported as a mean with a range of 0 (zero) to 5 (no units).~ref. Otolaryngol Head Neck Surg, 126 (2002), pp. 41–47"|1-day|Entire study population included.|||units on a scale|Participants|Standard Deviation|Mean
1441006|NCT00927888|Primary|Postoperative Pain Assessed on Standard VAS Scale|Post-operative quality of recovery and pain followed up to 1 month. Visual Analog Pain (VAS) was recorded by the patient on a 10-centimeter line to mark an estimated pain score that could be from zero (0) to ten (10). Zero would indicate no pain while a score of 10 would be the worse pain possible.|VAS Pain Score at 7 days|Entire population of both groups.|||units on a scale|Participants|Standard Deviation|Mean
1441007|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 in the Pharmacogenetic (PG)-Guided Dosing Arms and the Parallel Control Arm|What is reported is the percent of patients with an INR ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.|||percent||Standard Deviation|Mean
1441008|NCT00927862|Primary|The Time in Therapeutic Range (TTR) for the Pharmacogenetic-guided Patients and Parallel Controls|The percent of time in therapeutic INR range for the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) guided patients and parallel controls. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls.|||percent||95% Confidence Interval|Mean
1441009|NCT00927862|Primary|The Percent of Time in Therapeutic Range (TTR) for the Standard and Modified Pharmacogenetic Algorithms.|The percent of time in therapeutic INR range for the standard and modified pharmacogenetic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin inside of the target range was allowed in determine TTR values, ie, INRs 1.8-3.3 for INR 2.5 target; 2.25-3.85 for INR 3.0 target. What is reported is the percent of TTR for each patient during 1 month.|1 month (from baseline to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.|||percent||95% Confidence Interval|Mean
1441010|NCT00927862|Primary|The Percent of Out of Range (OOR) INRs in Pharmacogenetic-guided Patients and Parallel Controls|The percent of out of range (OOR) INRs in the pharmacogenetic (PG)-dosing (standard + modified IWPC warfarin algorithms) and parallel controls. A 10% margin outside of the target INR range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with OOR INRs at 1 month.|1 month (from day 3 to day 30)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls|||percent||95% Confidence Interval|Mean
1441011|NCT00927862|Secondary|Prediction of a Stable Maintenance Dose Among the Pharmacogenetic (PG)-Guided Dosing Algorithms and the Parallel Controls|Prediction of a stable maintenance dose (within 1 mg/day) among the pharmacogenetic (PG)-guided dosing and the parallel control group. For the parallel control group, an empiric starting dose of 5 mg/day was assumed. What is reported is the percent of patients who had their maintenance dose predicted as described above.|3 months (from baseline to 3 months or until stable dosing is achieved, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) and had a stable maintenance dose that could be determined were compared to parallel controls|||percent|||Number
1441012|NCT00927862|Secondary|The Number of INRs Measured up to 3 Months in the Pharmacogenetic (PG) (Modified and Standard) Algorithms and Parallel Controls.|What is reported is the mean number of INRs measured/drawn among the patients in each arm.|1-3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms) were compared to parallel controls|||INRs||Standard Deviation|Mean
1441013|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 or SAEs Among the Modified IWPC Warfarin Algorithm and Standard IWPC Warfarin Algorithm.|What is reported is the percent of patients with INRs ≥4 or ≤1.5 or having experienced a serious adverse event (SAE) at the end of follow-up.|3 months (from baseline to 3 months or end of warfarin therapy, whichever occurs first)|All patients receiving at least 1 dose of warfarin were included in safety analyses until 1 week after the last warfarin dose|||percent|||Number
1441014|NCT00927862|Secondary|The Percent of INRs ≥4 or ≤1.5 for the Modified IWPC Warfarin Algorithm and the Standard IWPC Warfarin Algorithm|The percent of INRs ≥4 or ≤1.5 for the pharmacogenetic (modified IWPC warfarin algorithm and the standard IWPC warfarin) algorithms. What is reported is the percent of patients with INRs ≥4 or ≤1.5 at the end of follow-up.|3 months (baseline to 3 months or to end of warfarin therapy, whichever occurs first)|All consented, randomized patients who were successfully genotyped and received at least 1 dose of warfarin with at least 1 postdose INR.|||percent||Standard Deviation|Mean
1441015|NCT00927862|Primary|The Percent of Out of Range (OOR) International Normalized Prothrombin Time Ratio (INRs) in the Standard and Modified Pharmacogenetic Arms.|The percent of out of range (OOR) international normalized prothrombin time ratio (INRs) in the standard and modified pharmacogentic algorithms at 1 month. To account for laboratory INR-measurement error, a 10% margin outside of the target range was allowed in determination of OOR values, ie, INRs <1.8, >3.3 for INR 2.5 target; <2.25, >3.85 for INR 3.0 target. What is reported is the percent of patients with an OOR INR at 1 month.|1 month (from day 3 to day 30)|Patients >= 18 years of age who have an indication for initiation of warfarin anticoagulation, gave written informed consent, and met other inclusion/exclusion criteria were studied.|||percent||95% Confidence Interval|Mean
1441016|NCT00927849|Primary|Relieve of Anal Pain|using a visual analog scale (VAS) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 ( severe pain)|one year after the procedure||||score in scale||Standard Deviation|Mean
1441017|NCT00927849|Primary|Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal|effect of closed lateral sphincterotomy and chemical sphincterotomy on hypertensive anal canal, anal manometery|one year|||||||
1441018|NCT00927823|Secondary|Number of Participants With Objective Response|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, prior to Day 1 of Cycle every odd-numbered cycle or when progressive disease was suspected|Response analysis set included all participants who started treatment and had an adequate baseline tumor assessment.|||participants|||Number
1441019|NCT00927823|Secondary|Number of Participants With Mutation, Deletion, Amplification in Phosphatidylinositol 3-kinase (PI3K) Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue|Biopsied tumor tissue was analyzed for alterations in the phosphoinositide-3-kinase/rat sarcoma (PI3K/RAS) signaling pathway by molecular approaches. The biomarkers studied were phosphoinositide-3-kinase, catalytic, alpha (PIK3CA) gene mutation, PIK3CA gene amplification, and phosphatase and tensin homolog (PTEN) protein deficiency status by immunohistochemistry.|Baseline; 4 hours post-dose on C1D21|Baseline tumor tissue biomarker analysis set: all enrolled participants who started treatment, had baseline tumor tissues (archived paraffin block/unstained slides/fresh tumor tissue) analyzed for at least 1 of biomarkers. N (number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at specified time point.|||participants|||Number
1441020|NCT00927823|Secondary|Change From Baseline in Hair Follicle Biopsy Biomarkers at Cycle 1 Day 21|Hair follicle biopsy samples analysis included assessment of status of proteins indicative of PI3K/mTOR related pathways signaling status and cell cycle status. The analytes measured were phosphorylated AKT S473, AKT T308, KI67, STAT3 (Y705) and proline-rich Akt substrate of 40 kilodaltons at Thr246 (PRAS40 T246). The method of analysis was reverse phase microarray (RPMA). The signal for each biomarker expressed as normalized fluorescence intensity (NFI) was normalized by their respective total protein concentration. This normalization was performed by dividing the biomarker NFI by total protein concentration (mg/mL) of the sample printed to give total protein normalized fluorescence unit (NFU). All clinical sample test results are reported in NFU.|Baseline; pre-dose, 2, 4, 24 hours post-dose on C1D21|Hair follicle analysis set included participants with hair follicles collected and analyzed for biomarkers at screening and on treatment. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.|||NFU||Standard Deviation|Mean
1441021|NCT00927823|Secondary|Change From Baseline in Fresh Tumor Biopsy Biomarkers at Cycle 1 Day 21|Fresh tumor biopsy samples analysis included assessment of status of proteins indicative of phosphoinositide 3-kinase/mammalian target of rapamycin (PI3K/mTOR) related pathways signaling status and cell cycle status. The biomarkers included phosphorylated activated kinase (AKT) S473, AKT T308, signal transducer and activator of transcription 3 (STAT3) and forkhead transcription factor Foxo1 (FKHR) T24/forkhead in rhabdomysacoma-like 1 (FKHRL1) T32. The method of analysis was reverse phase microarray (RPMA). The signal (normalized fluorescence unit [NFU]) for each pathway biomarker was normalized against the signal (NFU) for cytokeratin. The final concentration for each pathway biomarker was reported as a cytokeratin normalized fluorescence unit (NFC) value.|Baseline; 4 hours post-dose on C1D21|Fresh tumor biopsy analysis set included all enrolled participants in the tumor biopsy cohort who started treatment and had baseline and on-treatment fresh tumor tissue successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point. Only PF-04691502 8 mg treatment arm was evaluable for this outcome.|||NFC||Standard Deviation|Mean
1441022|NCT00927823|Secondary|Change From Baseline in Serum C-peptide at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum C-peptide level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively. Results of PF-04691502 2 mg and 4 mg arm not reported because none of the participants were evaluable.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1441023|NCT00927823|Secondary|Change From Baseline in Serum Insulin at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum insulin level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable at specified time point for each arm, respectively.|||micro International Unit/mL (mc IU/mL)||Standard Deviation|Mean
1441024|NCT00927823|Secondary|Change From Baseline in Serum Glucose at Cycle 1 Day 8 (C1D8), C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and End of Treatment (EOT)|Serum glucose level was measured following 4 hours fasting. EOT data included values from participants who came off-treatment before cycle 8.|Baseline, C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1 and EOT|Serum biomarker analysis set included all enrolled participants who started treatment and had baseline and on-treatment serum biomarker samples (insulin, glucose, and c-peptide) successfully analyzed for at least 1 of the biomarkers. n=participants evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1441025|NCT00927823|Secondary|Number of Participants With Maximum Post-dose QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants had at least 1 ECG assessment after receiving PF-04691502.|||participants|||Number
1441026|NCT00927823|Secondary|Number of Participants With Increase From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2-4 minutes) were performed and average calculated. QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds. End of treatment (EOT) data included values from participants who came off-treatment before cycle 8.|Pre-dose, 30 minutes, 1, 2, 4, 8, 24, 48, hrs post-dose in Lead-in period; 1 hour post-dose on C1D8, C1D15; 1, 2, 4, 8 hours post-dose on C1D21; 1 hour post-dose C2D1, C2D15, D1 of subsequent cycles up to C8; EOT|QTc analysis set included all enrolled participants who had at least 1 ECG assessment after receiving PF-04691502.|||participants|||Number
1441027|NCT00927823|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where tau is the dosing interval of 24 hours. It was evaluated following repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1441684|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||mmHg||Standard Deviation|Mean
1441028|NCT00927823|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1441029|NCT00927823|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half-life of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeat oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours (hrs) post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hrs post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.|||hours||Standard Deviation|Mean
1441030|NCT00927823|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). It was evaluated following a single oral dose in lead-in-dose period (single dose PK) only.|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1441031|NCT00927823|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|The PK of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on C1D21|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.|||hours||Full Range|Median
1441032|NCT00927823|Secondary|Maximum Observed Plasma Concentration (Cmax)|The pharmacokinetics (PK) of PF-04691502 was assessed following a single oral dose administration in lead-in-dose period (single dose PK) and repeated oral dose administration for 21 days in Cycle 1 (multiple dose PK).|Pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72, 96 hours post-dose in Lead-in period; pre-dose, 30 minutes, 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 21 (C1D21)|PK population included all randomized participants who received treatment and had at least 1 of the PK parameters of interest estimated. n=participants evaluable at specified time point for each arm, respectively.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1441033|NCT00927823|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined based on the safety profile and pharmacodynamic findings, as per investigator's discretion.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.|||milligram|||Number
1441034|NCT00927823|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 and defined as any of the following events occurring after first dose of study medication and considered at least possibly-related to study medication. Hematological: grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells per cubic millimeter [cells/mm^3]) for 1 week or greater, febrile neutropenia (fever >=38.5 degree celsius with ANC <1000/mm^3), grade 3 (50,000 cells/mm^3) and grade 4 (<25,000 cells/mm^3) thrombocytopenia; Non-Hematologic: grade 3 or 4 nausea, vomiting, or diarrhea and any clinically significant grade 3 or greater non-hematologic toxicity, despite the use of adequate/maximal medical intervention and/or prophylaxis, and any persistent, intolerable PF-04691502 related toxicity which delayed retreatment for >14 days.|Baseline up to Cycle 1 Day 21|Safety analysis set included all enrolled participants who started the treatment.|||participants|||Number
1441035|NCT00927823|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety analysis set included all enrolled participants who started the treatment.|||participants|||Number
1441036|NCT00927758|Primary|Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)|Percentage change in eNO was reported following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines. eNO was calculated 3 times every day in a treatment cycle for 7 days. The maximum value of all 3 collected value were collected for each seven days of the individual treatment cycle. Out of the maximum values, the minimum was taken and used for calculating the percentage change from baseline.|Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)|The per-protocol (PP) population was all subjects who completed the study with no major variances that would impair the analysis of the data|||Percentage change in eNO||Standard Deviation|Mean
1441037|NCT00927589|Primary|Minimum Observed Serum Trough Concentration (Cmin) of Trastuzumab||15 (±15) minutes prior to the start of the trastuzumab infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|PK analysis population for trastuzumab. n=participants with available data at each timepoint.|||mcg/mL||95% Confidence Interval|Geometric Mean
1441038|NCT00927589|Primary|Maximum Observed Serum Concentration (Cmax) of Trastuzumab||30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|The PK analysis population for trastuzumab included all participants who had at least 1 measurable serum trastuzumab concentration collected at a nominal sampling timepoint. Participants who did not receive a trastuzumab dose or for whom no trastuzumab PK samples were reported were excluded. n=participants with available data at each timepoint.|||mcg/mL||95% Confidence Interval|Geometric Mean
1441039|NCT00927589|Primary|Plasma Decay Half-Life (t1/2) of Carboplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin. n=participants with available data at each timepoint.|||hr||Standard Deviation|Mean
1441040|NCT00927589|Primary|Geometric Mean Ratio of AUC0-6hr/D of Carboplatin|The geometric mean ratio of AUC0-6hr/D of carboplatin was defined as the AUC0-6hr/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by AUC0-6hr/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||ratio||90% Confidence Interval|Geometric Mean
1441041|NCT00927589|Primary|Dose−Normalized AUC0-6hr (AUC0-6hr/D) of Carboplatin|AUC0-6hr/D = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion, normalized by carboplatin dose level.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||(hr*mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
1441042|NCT00927589|Primary|Geometric Mean Ratio of Cmax/D of Carboplatin|The geometric mean ratio of Cmax of carboplatin was defined as the Cmax/D of carboplatin on Cycle 1 Day 1 (in the absence of trastuzumab) divided by Cmax/D of carboplatin on Cycle 2 Day 1 (in the presence of trastuzumab).|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||ratio||90% Confidence Interval|Geometric Mean
1441043|NCT00927589|Secondary|Population Pharmacokinetics of Trastuzumab|As per planned analysis, separate population pharmacokinetic analysis results are not available for the current study as this analysis is based on pooled data from multiple studies.|15 (±15) minutes prior to the start of the trastuzumab infusion, and 30 (±15) minutes after the end of the infusion on Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 3 Day 1|||||||
1441044|NCT00927589|Secondary|Number of Participants With Abnormal Changes in QRS Interval|Criteria for abnormal changes in QRS interval were defined as: >=25% change from baseline, an absolute value >110 msec, or >=25% change from baseline and an absolute value >110 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
1441045|NCT00927589|Secondary|Number of Participants With Abnormal Changes in PR Interval|Criteria for abnormal changes in PR interval were defined as: =>25 percentage (%) change from baseline, an absolute value >200 msec, or >=25% change from baseline and an absolute value >200 msec.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
1441046|NCT00927589|Secondary|Number of Participants With New Abnormal T Waves on ECG|The incidence of abnormal T-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: an inverted T, flat T, or biphasic T compared with baseline was considered an abnormal significant change from baseline. Additionally, nonspecific T-wave changes from baseline were considered as abnormal nonsignificant changes from baseline. T-wave changes from baseline due to ventricular conduction or left ventricular hypertrophy strain were considered not evaluable.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
1441047|NCT00927589|Secondary|Number of Participants With New Abnormal U Waves on ECG|The incidence of abnormal U-wave changes from baseline was determined based on centrally read ECG tracings comparing each of the three triplicate readings from the post baseline ECG time points to the baseline ECG reading. At each time point, if at least one of the three triplicate readings was abnormal, the participant was counted as abnormal for that ECG timepoint as follows: a large U wave, inverted U wave, or T-U fusion compared with baseline was considered an abnormal significant change from baseline.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
1441048|NCT00927589|Secondary|Number of Participants With Increase From Baseline in QTc Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of =>30msec, 30 to <60 msec (borderline) and >=60 msec (prolonged) were summarized.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
1441060|NCT00927563|Primary|Clinical Global Impression Scale (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is assessed at every visit (1-5), but only the final visit will be reported here.|Visit 5 (final visit)||||units on a scale||Standard Deviation|Mean
1441100|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 12 Endpoint|CTX is a measure of bone resorption.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months CTX measurement.|||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
1441049|NCT00927589|Secondary|Number of Participants Within Each Absolute QTc Interval Category|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR) and by Bazette’s formula (QTcB = QT divided by square root of RR). Participants with maximum QTc less than or equal to (<=) 450 msec, greater than (>) 450 to <=470 msec, >470 to <= 500 msec, or >500 msec were reported.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||participants|||Number
1441050|NCT00927589|Secondary|Baseline-adjusted Heart Rate|For each postbaseline timepoint, a participant’s corresponding baseline heart rate was subtracted from his or her average of the triplicate heart rate to create a “baseline-adjusted” corresponding heart rate for each participant at each postbaseline timepoint.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||beats per minute (bpm)||Standard Deviation|Mean
1441051|NCT00927589|Secondary|Baseline-adjusted QTcF, QTcB, PR Interval, and QRS Duration|For each postbaseline timepoint, a participant’s corresponding baseline measure was subtracted from his or her average of the triplicate ECG measure to create a “baseline-adjusted” corresponding ECG measure for each participant at each postbaseline timepoint.|Baseline, Cycle 1 Day 2 (30 minutes postdose), Cycle 1 Day 8 (15 minutes predose), Cycle 1 Day 8 (30 minutes postdose), Cycle 2 Day 1 (15 minutes predose), and Cycle 2 Day 1 (30 minutes postdose)|ECG-evaluable participant population. n=participants with available data at each timepoint.|||msec||Standard Deviation|Mean
1441052|NCT00927589|Secondary|Change From Baseline in Corrected QT Interval Using Bazett’s Correction (QTcB) at Trastuzumab Steady State|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette’s formula (QTcB = QT divided by square root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 and Cycle 2 Day 1 after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population|||msec||90% Confidence Interval|Mean
1441053|NCT00927589|Primary|Dose-Normalized Cmax (Cmax/D) of Carboplatin|Dose normalized Cmax is the maximum observed concentration of carboplatin in plasma normalized for different dose levels.|0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||(mcg/mL)/(min*mg/mL)||Standard Deviation|Mean
1441054|NCT00927589|Primary|Area Under the Curve From Time Zero to 6 Hours Post Infusion (AUC0-6hr) of Carboplatin|AUC0-6hr = Area under the plasma concentration versus time curve from 0 to 6 hours post-infusion.|0 to 5, 60 (±5), 120 (±10), 240 (±10), and 360 (±15) minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The PK analysis population for carboplatin|||Hour*microgram/milliliter (hr*mcg/mL)||Standard Deviation|Mean
1441055|NCT00927589|Primary|Maximum Observed Plasma Concentration (Cmax) of Carboplatin||0 to 5 minutes after end of infusion on Cycle 1 Day 1 (in absence of trastuzumab) and Cycle 2 Day 1 (in presence of trastuzumab)|The pharmacokinetic (PK) analysis population for carboplatin included all participants who had a measurable ultrafiltrate or plasma carboplatin concentration at all nominal sampling time points. Participants for whom a full set of carboplatin PK samples in both Cycle 1 and Cycle 2 was not reported were excluded.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1441056|NCT00927589|Primary|Change From Baseline in Corrected QT Interval Using Fridericia’s Correction (QTcF) at Trastuzumab Steady State|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Trastuzumab steady state was defined as the average of the 2 ECG measurements collected on Cycle 1 Day 8 (C1D8) and Cycle 2 Day 1 (C2D1) after the trastuzumab infusion.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|ECG-evaluable participant population: received any trastuzumab, had at least 1 interpretable baseline ECG measurement recorded on C1D2 prior trastuzumab exposure, had at least 1 interpretable ECG measurement recorded on C1D8 or C2D1 corresponding to time of steady-state trastuzumab concentration, and no infusion reaction requiring drug treatments.|||milliseconds (msec)||90% Confidence Interval|Mean
1441057|NCT00927576|Primary|Performance in TBI Patients and Controls|Subjects were assessed on a set of cognitive tests. Here we describe the results on the simple reaction time test in which subjects respond as rapidly as possible to the computer-controlled occurrence of a visual stimulus by pressing a mouse button. Two control groups were used. One large control group underwent a single test to provide data from subjects with a broad range of age and education. The other, smaller, control group underwent three tests at weekly intervals to evaluate the test-retest reliability of the measure.|Subjects were tested in a single 2-hr session.|Data from two TBI patients were excluded due to suspected suboptimal effort.|||ms||Standard Deviation|Mean
1441058|NCT00927563|Secondary|Gambling Symptom Assessment Scale (G-SAS)|Self report test of severity of gambling on a scale from 0-48 with 48 being the most severe. The G-SAS was performed at every visit (1-5), but only the final visit (visit 5) will be reported here as a final score.|Visit 5 (final visit)||||units on a scale||Standard Deviation|Mean
1441059|NCT00927563|Secondary|Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS)|Scale used to measure severity of gambling. Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The PG-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported.|Visit 5 (final visit)||||units on a scale||Standard Deviation|Mean
1441217|NCT00926536|Primary|Dose Area Product (DAP)|Dose area product (DAP) is a measure of the entire amount of energy (radiation dose) delivered to the patient by the beam (indicator of stochastic dose)|Duration of a TACE procedure, an average of 2 hours|DAP measured in both groups|||Gy.cm2||Full Range|Mean
1441061|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)|"Treatment Success in the Modified ITT (non LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."|||percentage of subjects|||Number
1441062|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)|"Treatment Success in the Modified ITT (LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the Modified ITT was considered supportive."|3 weeks|"The evaluations was in the Modified ITT was considered supportive. The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 199; frequency missing = 33."|||percentage of subjects|||Number
1441063|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP|"Treatment Success in the PPP~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~The evaluations in the PPP was considered supportive."|3 weeks|"The evaluations in the PPP was considered supportive The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 188; frequency missing = 33."|||percentage of subjects|||Number
1441064|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))|"Treatment Success in the Efficacy ITT (non LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|"Treatment Success was evaluated in the Efficacy ITT(non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.~Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13."|||percentage of subjects|||Number
1441065|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).|"Treatment Success in the Modified ITT (non-LOCF)~The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit.~Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified ITT (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.|||percentage of subjects|||Number
1441066|NCT00927472|Primary|Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)|"Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF)~The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF"|3 weeks|Treatment Success in the Modified Intention to Treat ( Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF.|||percentage of subjects|||Number
1441067|NCT00927472|Primary|Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment|"Treatment Success in the Per Protocol Population (PPP)~The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive."|3 weeks|The Per-Protocol Population (PPP) included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.|||percentage of subjects|||Number
1441068|NCT00927472|Primary|Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment|"Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF)~The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)."|3 weeks|Treatment Success in the Efficacy ITT (No LOCF) The Efficacy ITT population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.|||percentage of subjects|||Number
1441069|NCT00927472|Secondary|Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))|"Treatment Success in the Efficacy ITT (LOCF)~The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment."|3 weeks|Treatment Success in the Efficacy ITT (LOCF). The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. Based on the protocol predefined imputation of missing efficacy data, the effective sample size = 82; frequency missing = 13.|||percentage of subjects|||Number
1441070|NCT00927472|Primary|Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.|"Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive.~The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).~Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))"|3 weeks|"The Efficacy Intention to Treat (eITT) population was the primary population for demonstrating the superiority of the Malathion product to the active control Nix® Crème Rinse.~eITT population: included all index subjects with at least one application of treatment.~Proportion of Subjects that are lice-free 14 days after their last treatment"|||percentage of subjects|||Number
1441099|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 1, 3 and 6 Endpoint|PINP is a measure of bone formation.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.|||microgram/Liter (µg/L)||Inter-Quartile Range|Median
1441071|NCT00927394|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|"Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.~Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards."|8 weeks|Safety Set — Consisted of all patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received.|||Patients|||Number
1441072|NCT00927394|Secondary|Change From Baseline in Plasma Aldosterone at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||pmol/L||Standard Deviation|Mean
1441073|NCT00927394|Secondary|Change From Baseline in Plasma Renin Concentration (PRC) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||ng/L||Standard Deviation|Mean
1441074|NCT00927394|Secondary|Change From Baseline in Plasma Renin Activity (PRA) at Week 8||Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||ng/mL/hr||Standard Deviation|Mean
1441075|NCT00927394|Secondary|Percentage of Responders|Responders were defined as patients with MSSBP <130 mmHg or a reduction from baseline in MSSBP of >20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.|Baseline, Week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis.|||Percentage of patients|||Number
1441076|NCT00927394|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control was defined as MSSBP/MSDBP <140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported|8 weeks|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed.|||Percentage of patients|||Number
1441077|NCT00927394|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8|At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.|baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.|||mmHg||Standard Deviation|Mean
1441078|NCT00927394|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.|||mmHg||Standard Deviation|Mean
1441079|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8|The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.|||mmHg||Standard Deviation|Mean
1441080|NCT00927394|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8|The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.|||mmHg||Standard Deviation|Mean
1441081|NCT00927394|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.|Baseline, week 8|Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used.|||mmHg||Standard Deviation|Mean
1441082|NCT00927394|Primary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8|The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient’s available hourly means for post-dosing hours 1-24.|baseline, week 8|Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)— Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments.|||mmHg||Standard Deviation|Mean
1441083|NCT00927368|Secondary|Incremental Cost of Femoral Nerve Blocks|The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate.|postoperative period when block is used||||dollars||Standard Deviation|Mean
1441084|NCT00927368|Secondary|Block Performance Time|Block performance time, defined as the time from block start until catheter placement.|time elapsed from beginning the block to catheter placement||||seconds||95% Confidence Interval|Mean
1441085|NCT00927368|Primary|Opioid Consumption|cumulative opioid consumption, where all opioids were converted to IV morphine equivalents|48 hours after surgery||||mg morphine equivalents||Inter-Quartile Range|Median
1441086|NCT00927368|Primary|Time Weighted Average Verbal Response Scale Pain Score|"Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).~Verbal Response Scale (VRS) pain scores after surgery – which ranged from 0 (no pain) to 10 (maximum intolerable pain) – were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.)."|48 hours after surgery||||units on a scale||Standard Deviation|Mean
1441087|NCT00927355|Secondary|Bone Mineral Density||6 months||||percent change from baseline to 6 months||Standard Error|Mean
1441088|NCT00927355|Secondary|βCTX (Carboxy Terminal Collagen Crosslinks), Osteocalcin, and Adiponectin.||6 months||||percent change from baseline||Standard Error|Mean
1441089|NCT00927355|Primary|Percent Change in Number of Osteoblast and Adipocyte Colony Forming Units Cultured From Bone Marrow Stem Cells Harvested 6 Months After Treatment With Study Drug Compared to Baseline|To determine the effect of PIO (pioglitazone) on BMSC (bone marrow stem cell) lineage choice in vivo, a bone marrow aspiration was obtained from patients at baseline and after 6 months of treatment with PIO or placebo. The bone marrow was used for ex vivo CFU-OB (Colony forming units-Osteoblast) and CFU-AD assays using the same protocol described for the in vitro studies previously. We also analyzed the number of total colonies per patient at both baseline and final visit.|6 months||||percent change from baseline to 6months||Standard Error|Mean
1441090|NCT00927264|Secondary|Number of Participants Who Report Endorsing a Home Smoking Ban|Number of participants endorsing presence of home smoking ban|Measured at baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact|||Participants|||Count of Participants
1441091|NCT00927264|Secondary|Health Care Utilization by Child- Self Report From Parent/Caregiver|Parent caregiver reported urgent care visits, number of hospitalizations, and number of emergency department visits in the 12 months prior for child enrolled in study|Measured at baseline and 3, 6 and 12 months||||Participants|||Count of Participants
1441092|NCT00927264|Secondary|Respiratory Function of Child by Self Report of Parent|Number of cold infections child experienced in previous 3 months, reported by caregiver|Measured at Baseline, 3, 6, and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact or caregiver refused or did not fully complete survey|||cold infections||Standard Deviation|Mean
1441093|NCT00927264|Secondary|ETS Reduction, as Measured by Child's Cotinine Levels|Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction|Measured at Baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact, samples not able to be analyzed due to insufficient quantity of saliva collected, or child not available during assessment.|||ng/mL||Inter-Quartile Range|Median
1441094|NCT00927264|Primary|Air Nicotine Levels|Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)|Measured at Baseline, 3, 6 and 12 months|The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact|||mg/m^3||Inter-Quartile Range|Median
1441095|NCT00927251|Primary|Number of Participants With Left Ventricular (LV)Lead Related Complications|A LV lead related complication occurs when an invasive procedure is needed to correct an adverse event related to the LV lead.|Implant to one-month post implant|All subjects implanted with the lead who had completed their one-month post-implant/or a later follow-up visit, or have had a complication by the one-month post-implant visit, were included in the analysis. A complication is defined as an Adverse Event that results in death, any termination of significant device function or invasive intervention|||participants|||Number
1441096|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 12 Endpoint|OC is a measure of osteoblast function.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months OC measurements.|||microgram/liter (µg/L)||Inter-Quartile Range|Median
1441097|NCT00927186|Secondary|Change From Baseline in Serum Osteocalcin (OC) at Month 1, 3, and 6 Endpoint|OC is a measure of osteoblast function.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.|||µg/L||Inter-Quartile Range|Median
1441098|NCT00927186|Secondary|Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 12 Endpoint|PINP is a measure of bone formation.|Baseline, 12 months|All participants who received at least one dose of study drug, had baseline and 12 months PINP measurement.|||microgram/liter (µg/L)||Inter-Quartile Range|Median
1441218|NCT00926497|Primary|Absolute Duration of Antibiotic Therapy|Co-primary endpoint was the absolute duration of antibiotic therapy(quantitative version of the primary endpoint for estimation of effect size)|1 month||||hours||Full Range|Mean
1441101|NCT00927186|Secondary|Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 1, 3 and 6 Endpoint|CTX is a measure of bone resorption.|Baseline, 1, 3, 6 months|All randomized participants who received at least one dose of study drug with available biochemical marker of bone turnover data.|||nanogram/milliliter (ng/mL)||Inter-Quartile Range|Median
1441102|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Eroded surface/bone surface (ES/BS) in the endocortical compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the EC at 6 and 24 months.|||percentage of surface||Inter-Quartile Range|Median
1441103|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had ES/BS analysis of the CC at 24 months.|||percentage of surface||Inter-Quartile Range|Median
1441104|NCT00927186|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Eroded surface/bone surface (ES/BS) in the cancellous compartment is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of surface||Inter-Quartile Range|Median
1441105|NCT00927186|Secondary|Wall Thickness (WTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Wall thickness (WTh.) in the endocortical compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the EC at 6 and 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
1441106|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had WTh. analysis of the CC at 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
1441107|NCT00927186|Secondary|Wall Thickness (WTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Wall thickness (WTh.) in the cancellous compartment is measured as the mean distance from the cement line to the marrow space of completed trabecular bone packets.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||µm||Inter-Quartile Range|Median
1441108|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid thickness (OTh.) in the endocortical compartment is a measure of the average thickness of osteoid seams.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the EC at 6 and 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
1441109|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OTh. analysis of the CC at 24 months.|||micrometer (µm)||Inter-Quartile Range|Median
1441110|NCT00927186|Secondary|Osteoid Thickness (OTh.) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid thickness (OTh.) in the cancellous compartment is a measure of the average thickness of osteoid seams.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||micrometer (µm)||Inter-Quartile Range|Median
1441111|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Osteoid surface (OS) in the endocortical compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the EC at 6 and 24 months.|||percentage of surface||Inter-Quartile Range|Median
1441112|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OS/BS analysis of the CC at 24 months.|||percentage of surface||Inter-Quartile Range|Median
1441113|NCT00927186|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid surface (OS) in the cancellous compartment is the fraction (%) of the entire trabecular bone surface that is covered by osteoid.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of surface||Inter-Quartile Range|Median
1441114|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had OV/BV analysis of the CC at 24 months.|||percentage of volume||Inter-Quartile Range|Median
1441115|NCT00927186|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Osteoid volume (OV) in the cancellous compartment is the percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of volume||Inter-Quartile Range|Median
1441219|NCT00926497|Primary|Antibiotic Treatment for More Than 72 Hours|Infants treated with antibiotics for more than 72 hours (efficacy of study intervention)|1 month||||participants|||Number
1441116|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the endocortical compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the endocortical compartment at 6 and 24 months.|||millimeter (mm)||Inter-Quartile Range|Median
1441117|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had length of tetracycline double labels analysis of the cancellous compartment at 24 months.|||millimeter (mm)||Inter-Quartile Range|Median
1441118|NCT00927186|Secondary|Average Length of Tetracycline Double Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The length of tetracycline double labels is a measure of the extent of bone formation in the cancellous compartment within individual remodeling units and is measured in millimeters (mm). Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||millimeter (mm)||Inter-Quartile Range|Median
1441119|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the endocortical compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the endocortical compartment at 6 and 24 months.|||samples|||Number
1441120|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy of the cancellous compartment at 24 months.|||samples|||Number
1441121|NCT00927186|Secondary|Number of Samples With Single or Double Tetracycline Labels, Single and Double Labels, or No Tetracycline Labels in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|Number of samples with single or double tetracycline labels, both single and double labels, or no labels in the cancellous compartment were compared between teriparatide and zoledronic acid treated participants. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||samples|||Number
1441122|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Endocortical Compartment of Iliac Crest Bone Biopsies at 6 and 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the endocortical compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the endocortical compartment at 6 and 24 months.|||percentage of tetracycline labels||Inter-Quartile Range|Median
1441123|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 24 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had sLS/BS and dLS/BS analysis of the cancellous compartment at 24 months.|||percentage of tetracycline labels||Inter-Quartile Range|Median
1441220|NCT00926393|Secondary|Number of Patients With Potential Somnolence|Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence|From start of the study treatment to last dose plus 30 days||||Patients|||Number
1441685|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||mmHg||Standard Deviation|Mean
1441124|NCT00927186|Secondary|Percent of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS), (dLS/BS) in the Cancellous Compartment of Iliac Crest Bone Biopsies at 6 Months|The percent of single or double tetracycline labels per bone surface (sLS/BS, dLS/BS) in the cancellous compartment. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of tetracycline labels||Inter-Quartile Range|Median
1441125|NCT00927186|Secondary|Active Formation Period (a.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|a. FP in EC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3 day-periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the EC at 6 and 24 months.|||year||Inter-Quartile Range|Median
1441126|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had a.FP analysis of the CC at 24 months.|||year||Inter-Quartile Range|Median
1441127|NCT00927186|Secondary|Active Formation Period (a.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|a. FP in CC is the mean time required to rebuild a new bone structural unit, calculated as wall thickness divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||year||Inter-Quartile Range|Median
1441128|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Tt.FP in EC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the EC at 6 and 24 months.|||year||Inter-Quartile Range|Median
1441129|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Tt.FP analysis of the CC at 24 months.|||year||Inter-Quartile Range|Median
1441130|NCT00927186|Secondary|Total Formation Period (Tt.FP) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Tt.FP in CC is a measure of bone formation and is calculated as wall thickness divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||year||Inter-Quartile Range|Median
1441131|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Omt in EC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 Months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the EC at 6 and 24 months.|||day||Inter-Quartile Range|Median
1441132|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Omt analysis of the CC at 24 months.|||day||Inter-Quartile Range|Median
1452618|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 06 (Month 6; 180 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1441133|NCT00927186|Secondary|Osteoid Maturation Time (Omt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Omt in CC is the period between the onset of deposition and onset of mineralization of a given amount of osteoid. Omt is calculated as O.Th divided by MAR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||day||Inter-Quartile Range|Median
1441134|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Mlt in EC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the EC at 6 and 24 months.|||day||Inter-Quartile Range|Median
1441135|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as O.Th divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Mlt analysis of the CC at 24 months.|||day||Inter-Quartile Range|Median
1441136|NCT00927186|Secondary|Mineralization Lag Time (Mlt) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Mlt in CC is the period between deposition and subsequent mineralization of osteoid. Mlt is calculated as Osteoid Thickness (O.Th) divided by Aj.AR. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||day||Inter-Quartile Range|Median
1441137|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Aj.AR in EC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the EC at 6 and 24 months.|||micrometer (µm)/day||Inter-Quartile Range|Median
1441138|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Aj.AR analysis of the CC at 24 months.|||micrometer (µm)/day||Inter-Quartile Range|Median
1441139|NCT00927186|Secondary|Adjusted Apposition Rate (Aj.AR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Aj.AR in CC is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||µm/day||Inter-Quartile Range|Median
1441140|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MAR in EC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the EC at 6 and 24 months.|||micrometer (µm/day)||Inter-Quartile Range|Median
1441158|NCT00927082|Secondary|Quantitative HBsAg|Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||log10 IU/mL||Standard Deviation|Mean
1452619|NCT00833690|Secondary|Serum Urate|From blood sample drawn before taking study drug that day|Visit 05 (Week 12; 84 +/- 7 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1441141|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MAR analysis of the CC at 24 months.|||micrometer (µm)/day||Inter-Quartile Range|Median
1441142|NCT00927186|Secondary|Mineral Apposition Rate (MAR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MAR in CC is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between two consecutive T labels divided by the time interval. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||micrometer (µm)/day||Inter-Quartile Range|Median
1441143|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|BFR in EC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of EC at 6 and 24 months.|||mm³/mm²/year||Inter-Quartile Range|Median
1441144|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (mm³/mm²/year); calculated as MAR times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had BFR analysis of the CC at 24 months.|||mm³/mm²/year||Inter-Quartile Range|Median
1441145|NCT00927186|Secondary|Bone Formation Rate (BFR) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|BFR in CC is the volume of mineralized bone formed per unit surface bone per unit time (cubic millimeter/square millimeter/year [mm³/mm²/year]); calculated as mineral apposition rate (MAR) times MS/BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||mm³/mm²/year||Inter-Quartile Range|Median
1441146|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|Ac.f in EC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the EC at 6 and 24 months.|||new cycles/year||Inter-Quartile Range|Median
1441147|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on the bone surface (BFR/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had Ac.f analysis of the CC at 24 months.|||new cycles/year||Inter-Quartile Range|Median
1441148|NCT00927186|Secondary|Activation Frequency (Ac.f) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|Ac.f in CC represents the frequency of activation of new remodeling cycles on BS (bone formation rate [BFR]/BS divided by wall thickness) and is expressed in units of new cycles per unit of time. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in biopsy is seen as amount of bone between 2 fluorescently T labeled lines under microscope. DL indicates active bone formation, SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 micrometer (µm)/day or counted as missing.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||new cycles/year||Inter-Quartile Range|Median
1441221|NCT00926393|Secondary|Number of Patients With Potential Extrapyramidal Symptoms (EPS)|Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness|From start of the study treatment to last dose plus 30 days|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||Patients|||Number
1441149|NCT00927186|Secondary|Mineralizing Surface/Bone Surface(MS/BS) in the Endocortical Compartment (EC) of Iliac Crest Bone Biopsies at 6 and 24 Months|MS/BS in EC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 and 24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the EC at 6 and 24 months.|||percentage of surface||Inter-Quartile Range|Median
1441150|NCT00927186|Secondary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 24 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|24 months|All participants who received at least one dose of study drug with an evaluable bone biopsy and had MS/BS analysis of the CC at 24 months.|||percentage of surface||Inter-Quartile Range|Median
1441151|NCT00927186|Primary|Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Compartment (CC) of Iliac Crest Bone Biopsies at 6 Months|MS/BS in CC is a measure of the proportion of BS on which new mineralized bone is deposited at the time of tetracycline (T) labeling and is calculated as sum of total extent of double label (DL) plus half the extent of single label (SL) divided by BS. Participants were given T for two 3-day periods, 14 days apart. T fluoresces under certain light and temporarily binds to new bone. New bone in the biopsy is seen as the amount of bone between 2 fluorescently T labeled lines under a microscope. DL indicates active bone formation, SL or no label (NL) suggests suppression of bone formation.|6 months|All randomized participants who received at least one dose of study drug with an evaluable bone biopsy.|||percentage of surface||Inter-Quartile Range|Median
1441152|NCT00927160|Secondary|Rehospitalization Rate|30 days for readmission rate|30 days||||percentage of particpants|||Number
1441153|NCT00927160|Primary|Length of Hospital Stay||Depending on hospital stay||||days||Standard Deviation|Mean
1441154|NCT00927095|Primary|Pre-Post Change in Premenstrual Symptom Severity|"Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: mean rating on the individual's worst symptom during the premenstrual week at baseline minus mean rating during the premenstrual week during the last on-treatment cycle. Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial."|monthly||||units on a scale||Standard Deviation|Mean
1441155|NCT00927082|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche’s following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.|||Participants|||Number
1441156|NCT00927082|Secondary|Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)|Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).|Up to 5-year FU period|The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.|||Participants|||Number
1441157|NCT00927082|Secondary|Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B|Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.|Up to 5-year FU period|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Participants|||Number
1441233|NCT00926380|Primary|Change in Spine Bone Density From Baseline to 2 Years||Baseline and 2 years||||percent change||Standard Error|Mean
1441280|NCT00926263|Primary|Plasma Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).|||mL/day/kg||Standard Deviation|Mean
1441159|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441160|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)|The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441161|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).|The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441162|NCT00927082|Primary|Percentage of Participants With HBsAg Loss|HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage||95% Confidence Interval|Number
1441163|NCT00927082|Secondary|Percentage of Participants With Normalised Alanine Transaminase (ALT)|Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441164|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-HBs|The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441165|NCT00927082|Secondary|Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).|The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441166|NCT00927082|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441167|NCT00927082|Secondary|Percentage of Participants With HBeAg Loss.|HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.|Annually, for up to 5 years|The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441200|NCT00926796|Secondary|Resolution of Symptoms and Signs (Clinical Cure)|Number of participants whose gonorrhea-related symptoms (e.g. vaginal/urethral discharge, dysuria, dyspareunia) present at enrollment has resolved by visit 2.|10-17 days after treatment.|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||participants|||Number
1441168|NCT00927082|Primary|Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.|Annually, for up to 5 years|The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.|||Percentage of participants||95% Confidence Interval|Number
1441169|NCT00927069|Secondary|Total Number of Adverse Events for All Patients in the Study.|Safety of adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of therapy with etanercept|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Adverse events|||Number
1441170|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at Week 24.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
1441171|NCT00927069|Secondary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.|"Efficacy of adalimumab in patients from Group B who achieve a Physician's global assessment (PGA) of clear or almost clear at Week 24.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|24 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
1441172|NCT00927069|Secondary|Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at week 12.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
1441173|NCT00927069|Primary|Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.|"Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12.~Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration.~Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration."|12 weeks|The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)|||Participants|||Number
1441174|NCT00926952|Secondary|Number of Adverse Events|To study the safety of MAL-PDT performed without occlusion when red light exposure takes place 90 minutes after the application of MAL by tracking adverse events until week 12 and adverse events until week 24|12, 24 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Adverse events|||Number
1441175|NCT00926952|Secondary|Mean Mottled Hyperpigmentation at Week 12|"This factor represents a visual assessment of light, patchy, mottled hyperpigmentation and solar freckling (including melasma) based on quantitative criteria such as the area/density of pigment, color intensity (dark vs. light), and uniformity of distribution (i.e. the more uneven or blotchy, the greater the score), Lentigines, nevi, and other pigmented lesions are not to be included in this assessment.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
1441176|NCT00926952|Secondary|Mean Sallowness Score at Week 12|"This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
1441177|NCT00926952|Secondary|Mean Coarse Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of coarse wrinkles (i.e. deep lines, furrows, or creases). Coarse wrinkles appear on the forehead, glabella, chin, and nasolabial and periorbital areas, and they tend to be located closer to the eyes and mouth than fine wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
1441178|NCT00926952|Secondary|Mean Fine Wrinkling Score at Week 12|"This factor represents a visual assessment of the number and depth of superficial wrinkles (i.e. shallow indentations or lines). Fine wrinkles typically appear in periorbital and perioral regions and are usually found further from the eyes and mouth than are coarse wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe"|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
1452620|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 04 (Week 9; 63 +/- 5 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1441179|NCT00926952|Secondary|Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12|Griffiths photonumeric scale was evaluated by the dermatologist. Patients were placed under natural daylight or fluorescent lighting for grading. A direct comparison was then made between the subjects and photographic standards (provided in reference 1). If an exact match could not be made to a grade then an inter-grade number was used used, for example 1, 3, 5, or 7. Zero (0) is the least amount of photodamage, 8 is the most amount of photodamage.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Units on a scale||Standard Deviation|Mean
1441180|NCT00926952|Secondary|Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12||0, 12 weeks||||Lesions|||Number
1441181|NCT00926952|Secondary|Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12|The proportion of patients with a complete clinical response is calculated by dividing the number of patients with a complete response at week 12 by the number of participants at baseline.|12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Participants|||Number
1441182|NCT00926952|Primary|Mean Number of Facial Actinic Keratoses at Week 12||12 weeks|The analysis was per protocol (PP). Imputation techniques were not required since all patients completed the study and no visits were missed.|||Lesions||Standard Deviation|Mean
1441183|NCT00926887|Primary|Self-reported Pain Rating on the 0-100 VAS 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 VAS scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. VAS values range from '0' representing 'no pain at all' to '100' representing 'worst pain imaginable.'|24 hours|Intention to treat (ITT) analysis with imputation technique of Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
1441184|NCT00926887|Secondary|Wound Healing Evaluation According to the Modified Hollander Cosmesis Scale||7 days post surgery|||||||
1441185|NCT00926887|Secondary|Infection Evaluation||24 hours & 7 days post surgery|||||||
1441186|NCT00926887|Secondary|Hydration Level Assessment||immediately, 24 hours & 7 days post surgery.|||||||
1441187|NCT00926887|Secondary|Use of Pain Management Medication Post-surgically.|Average number of rescue pain medication doses consumed across the 1st 7 post-operative days.|Through the 1st 7 post-operative days.|ITT with LOCF|||medication doses||Standard Deviation|Mean
1441188|NCT00926887|Secondary|Self-reported Degree of Pain Rating in the Breasts Area.||24 hours, 7 days, 14 days & 28 days post surgery|||||||
1441189|NCT00926887|Secondary|Swelling Evaluation Through Length by Width Breast Diameter Measurements||immediately, 24 hours & 7 days post surgery|||||||
1441190|NCT00926887|Primary|Number of Participants Who Scored Less Than 30 on the 0-100 Visual Analog Scale (VAS)for Pain 24 Hours Post-operative.|Self-reported Degree of Pain rating using the standardized 0-100 Visual Analog Scale (VAS) scale provided at 24 hours post-implant procedure, at which time the subject will not have taken any pain medication for at least four hours. The VAS ratings range from 0 to 100, where '0' represents 'no pain at all' and '100' represents 'worst pain imaginable.' A VAS of 30 is indicated as a cutoff threshold for 'success.' Participants who recorded a VAS rating of less than 30 were considered study 'successes' and are reported below.|24 hours post-operative|ITT Analysis with LOCF technique employed, as applicable.|||participants|||Number
1441191|NCT00926848|Secondary|Functional Capacity in Partners|Exercise tolerance test using a treadmill|6 months post baseline||||Metabolic equivalents (METs)||Standard Deviation|Mean
1441192|NCT00926848|Secondary|Functional Capacity in Patients|Exercise tolerance test using a treadmill|6 months post baseline||||Metabolic equivalents (METs)||Standard Deviation|Mean
1441193|NCT00926848|Primary|Eating Behavior (% Saturated Fat) in Partners|Eating behavior (% saturated fat) was measured using a 3-day food record.|6 months post baseline||||percent saturated fat per day||Standard Deviation|Mean
1441194|NCT00926848|Primary|Eating Behavior (% Saturated Fat) in Patients|Eating behavior (% saturated fat) was measured using a 3-day food record.|6 months post baseline||||percent saturated fat per day||Standard Deviation|Mean
1441195|NCT00926848|Primary|Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners|Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.|6 months post enrollment/baseline||||minutes per day||Standard Deviation|Mean
1441196|NCT00926848|Primary|Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients|Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.|6 months post enrollment/baseline||||minutes per day||Standard Deviation|Mean
1441197|NCT00926796|Secondary|Number of Participants With Adverse Events for Each Regimen|Number of treated participants experiencing mild, moderate, severe, or life-threatening adverse events (AEs) either temporarily associated or not associated with study product.|Day 0 through Day 30|All participants receiving study medication comprised the safety population. Of 614 participants randomized, 603 received study medication.|||participants|||Number
1441198|NCT00926796|Primary|Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||percentage of participants|||Number
1441199|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Enrollment Isolates.|Minimum inhibitory concentration (micrograms/milliliter) of pretreatment gonorrhea isolates collected from participants|Isolates obtained at enrollment (Day 0).|Per protocol population (all randomized participants who too study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.).|||micrograms/milliliter||Full Range|Median
1441216|NCT00926536|Primary|Cumulative Dose (CD), a Measure of Radiation Dose|CD - a measurement of total radiation to the skin (measure of a deterministic dose)|Duration of a TACE procedure, an average of 2 hours|CD measured in both groups|||mGy||Full Range|Mean
1441201|NCT00926796|Secondary|Clinical Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), number participants with clinical symptoms (vaginal/urethral discharge, dysuria, dyspareunia) at 10-17 days.|10-17 days|Participants who had clinical symptoms at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.|||participants|||Number
1441202|NCT00926796|Secondary|Antimicrobial Susceptibility Profile of Treatment Failures.|For treatment failures (i.e., participants with positive culture at cervix/urethra 10-17 days after treatment), the minimum inhibitory concentrations for various antimicrobial agents (Azithromycin, Cefixime, Ceftriaxone, Ciprofloxacin, Gemifloxacin, Gentamicin, Penicillin, Tetracycline).|Isolates obtained at enrollment (Day 0).|Participants in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.) with treatment failure.|||micrograms/milliliter||Full Range|Median
1441203|NCT00926796|Secondary|Eradication of Pharyngeal Infection|Number of enrollees with positive pharyngeal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for pharyngeal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||participants|||Number
1441204|NCT00926796|Secondary|Eradication of Rectal Infection|Number of enrollees with positive rectal culture at enrollment who have negative culture 10-17 days after treatment|10-17 days after treatment.|Participants who were positive for rectal gonorrhea at enrollment and were in the per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||participants|||Number
1441205|NCT00926796|Primary|Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection|Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure)|10-17 days after treatment.|Per protocol population (all randomized participants who took study drug, positive for gonorrhea, completed follow up visit, and met additional protocol specific conditions such as key inclusion/exclusion, the 10-17 day Visit 2 window requirement, etc.)|||percentage of participants|||Number
1441206|NCT00926783|Secondary|Incidence of Atrial Fibrillation (AF) Termination/Regularization|Incidence of Atrial Fibrillation (AF) termination/regularization is defined as AF terminates during a complex fractionated atrial electrograms (CFAE) procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data|||participants|||Number
1441207|NCT00926783|Secondary|Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target|Change in atrial fibrillation cycle length from baseline to the end of the ablation procedure for each target|Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours)|Per-protocol population with available outcome data|||Milliseconds||Standard Deviation|Mean
1441208|NCT00926783|Secondary|Fluoroscopy Time|"Fluoroscopy time is divided into: Fluoroscopy time for access - Time to track the NAVISTAR catheter to the chamber of interest; Fluoroscopy time to map - Creation of first workable map, ablation, and verification time; Fluoroscopy to create and verify all ablation points including pulmonary vein isolation and complex fractionated electrograms.~Fluoroscopy time for access is independent of the strategies and will not be included in comparative analysis."|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data|||Minutes||Standard Deviation|Mean
1441209|NCT00926783|Secondary|Duration of Ablation Procedure|Duration of ablation procedure includes three components: Access time - Time from first stick to tracking of the NAVISTAR catheter to the chamber of interest; Mapping time - Creation of first workable map; Ablation and verification time - Creation and verification of all ablation points including pulmonary vein isolation and complex fractionated electrograms.|Duration of ablation procedure (up to about 5 hours)|Per-protocol population with available outcome data|||Minutes||Standard Deviation|Mean
1441210|NCT00926783|Primary|Total Radio-frequency (RF) Delivery Time During CFAE|Total RF delivery time (minutes) is defined as the duration of the RF delivered per ablation site and totaled for each procedure.|Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours)||||Minutes||Standard Deviation|Mean
1441211|NCT00926783|Primary|Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.|Proportion of subjects who were free from atrial arrhythmia (no recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT)) between Day 91 and Day 365 post first ablation procedure.|From day 91 to day 365 post first ablation procedure|Per-protocol population - subjects who underwent repeat ablation procedures within six months of initial procedures.|||participants|||Number
1441212|NCT00926588|Primary|Brief Pain Inventory (Pain)|The full scale name is the Brief Pain Inventory. This 11-item scale measures self-reported pain severity and interference. It consists of 4 pain severity items and 7 pain interference items. Each item is scored from 0 (no pain) to 10 (worse pain imaginable). There is a pain severity score (average of 4 pain severity items), pain interference score (average of 7 pain interference items), and total pain score (average of all 11 items). For all 3 scores, 0 represents the best score (i.e., least pain) and 10 represents the worst score (i.e., greatest pain).|1 year||||units on a scale||Standard Deviation|Mean
1441213|NCT00926575|Secondary|Survival Status||Day 200|||||||
1441214|NCT00926575|Secondary|Cumulative Exposure to Prednisone||Day 80|||||||
1441215|NCT00926575|Primary|The Proportion of Subjects With GVHD Treatment Failure|The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD|Day 80|Data was not analyzed as the study was terminated due to futility||||||
1441222|NCT00926393|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score|AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||units on scale||Standard Deviation|Mean
1441223|NCT00926393|Secondary|Change in Barnes Akathisia Rating Scale (BARS) Global Score|BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||units on scale||Standard Deviation|Mean
1441224|NCT00926393|Secondary|Change in Simpson-Angus Scale (SAS) Total Score|SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms.|Randomization to Day 7|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||units on scale||Standard Deviation|Mean
1441225|NCT00926393|Secondary|Area Under the Modified Bond-Lader Visual Analog Scale-time Curve|Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose|During Day 2 (50 mg)|The randomized safety analysis data set included all patients who received at 1 dose of randomized study treatment during the Randomized treatment Phase, classified according to actual treatment taken.|||mm * hour||Standard Error|Least Squares Mean
1441226|NCT00926393|Secondary|Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||Hours||Standard Error|Least Squares Mean
1441227|NCT00926393|Secondary|Maximum Intensity Modified Bond-Lader Visual Analog Scale Score|The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments|During Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
1441228|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 6 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
1441229|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 5 (300 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
1441230|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 4 (200 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
1441231|NCT00926393|Secondary|Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 3 (100 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||Standard Error|Least Squares Mean
1441232|NCT00926393|Primary|Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)|The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) – Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100.|At 1 hour post-dose, Day 2 (50 mg)|The modified intent-to-treat (MITT) analysis data set included all randomized patients who received study treatment, classified according to their randomized treatment and provided the Modified Bond-Lader VAS score at baseline (pre-dose at Day 1 or Day 2) and at least 1 hour after 50 mg dose administration.|||units on scale||95% Confidence Interval|Least Squares Mean
1441234|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult"|Day 14||||units on a scale||Standard Deviation|Mean
1441235|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product?~The subject replied using the following scale:~- Very Satisfied~- Satisfied~- Neutral~- Unsatisfied~- Very Unsatisfied"|Day 14||||units on a scale||Standard Deviation|Mean
1441236|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up?~The subject replied using the following scale:~0 - Not Applicable~- Very Easy~- Easy~- Neutral~- Difficult~- Very Difficult"|Day 14||||units on a scale||Standard Deviation|Mean
1441237|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?~The subject replied using the following scale:~1 - Yes 0 - No"|Day 14||||units on a scale||Standard Deviation|Mean
1441238|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day?~The subject replied using the following scale:~0 - Not Compliant at all (<50%)~- Mostly Compliant (50%-79%)~- Very Compliant (80%-100%)"|Day 14||||units on a scale||Standard Deviation|Mean
1441239|NCT00926367|Secondary|Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?|"The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product?~The subject replied using the following scale:~- Very Comfortable~- Comfortable~- Somewhat Comfortable~- Somewhat Uncomfortable~- Uncomfortable"|Day 14||||units on a scale||Standard Deviation|Mean
1441240|NCT00926367|Secondary|Self Assessment of Oiliness|"The amount of oiliness on the left and right cheek of each panelist.~The scale used to evaluate oiliness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441241|NCT00926367|Secondary|Self Assessment of Blistering|"The amount of blistering on the left and right cheek of each panelist.~The scale used to evaluate blistering is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441242|NCT00926367|Secondary|Self Assessment of Crusting|"The amount of crusting on the left and right cheek of each panelist.~The scale used to evaluate crusting is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441243|NCT00926367|Secondary|Self Assessment of Pain|"The amount of pain on the left and right cheek of each panelist.~The scale used to evaluate pain is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441244|NCT00926367|Secondary|Self Assessment of Texture (Roughness)|"The amount of roughness on the left and right cheek of each panelist.~The scale used to evaluate roughness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441245|NCT00926367|Secondary|Self Assessment of Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate dryness is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441246|NCT00926367|Secondary|Self Assessment of Stinging|"The amount of stinging on the left and right cheek of each panelist.~The scale used to evaluate stinging is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441247|NCT00926367|Secondary|Self Assessment of Burning|"The amount of burning on the left and right cheek of each panelist.~The scale used to evaluate burning is:~Scale Description:~(scale: 0 = none to 3 = severe)~Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441248|NCT00926367|Secondary|Skin Hydration|"The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration.~Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration."|Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14||||Microsiemens||Standard Deviation|Mean
1441264|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7|SBP control is defined as SBP < 140 mmHg.|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441249|NCT00926367|Primary|Skin Dryness|"The amount of dryness on the left and right cheek of each panelist.~The scale used to evaluate skin dryness is:~Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring~Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14."|Baseline, Day 1 through Day 14||||units on a scale||Standard Deviation|Mean
1441250|NCT00926367|Secondary|Skin Moisture and Hydration|"To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels.~Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss."|Baseline, Days 3, 7, and 14||||TEWL rates (gm/m2/hr)||Standard Deviation|Mean
1441251|NCT00926367|Primary|Skin Erythema (Redness)|"Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below.~Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion"|Baseline, Day 1 through Day 14||||Units on a scale||Standard Deviation|Mean
1441252|NCT00926328|Primary|Plaque Index|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 Months|Per protocol|||Units on a scale||Standard Deviation|Mean
1441253|NCT00926328|Primary|Gingivitis Index|"Units on a scale 0 to 3 (0 = no inflammation ,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing.~3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|6 months||||Units on a scale||Standard Deviation|Mean
1441254|NCT00926289|Secondary|BP Categories at Week 7|"BP categories comprise:~BP optimal (SBP <120 mmHg and DBP <80 mmHg)~BP normal (SBP <130 mmHg and DBP <85 mmHg but not ‘optimal’)~BP high normal (SBP <140 mmHg and DBP <90 mmHg but not ‘normal’)~Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not ‘high normal’)~Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not ‘Grade 1 hypertension’)~Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)"|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441255|NCT00926289|Secondary|Number of Participants With DBP Response at Week 7|DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441256|NCT00926289|Secondary|Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7|SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441257|NCT00926289|Secondary|Number of Patients With BP Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441258|NCT00926289|Secondary|Number of Patients With Blood Pressure (BP) Control at Week 7|BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441259|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3|DBP control is defined as DBP<90 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441260|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5|DBP control is defined as DBP<90 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||participants|||Number
1441261|NCT00926289|Secondary|Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7|DBP control is defined as DBP<90 mmHg|Week 7 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441262|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3|SBP control is defined as SBP < 140 mmHg|Week 3 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441263|NCT00926289|Secondary|Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5|SBP control is defined as SBP < 140 mmHg|Week 5 timepoint|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||Participants|||Number
1441281|NCT00926263|Primary|Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.|||mg*h/L||Standard Deviation|Mean
1441265|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7|The DBP value at baseline was subtracted from the DBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
1441266|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 3|The SBP value at baseline was subtracted from the SBP value at Week 3.|Baseline and Week 3|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
1441267|NCT00926289|Secondary|Change From Baseline in Mean Seated Trough Cuff SBP to Week 5|The SBP value at baseline was subtracted from the SBP value at Week 5.|Baseline and Week 5|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
1441268|NCT00926289|Primary|Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7|The SBP value at baseline was subtracted from the SBP value at Week 7.|Baseline and Week 7|The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm|||mmHg||Standard Error|Least Squares Mean
1441269|NCT00926263|Secondary|Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples|Number of participants who tested positive for ADA|Day 1 pre-dose, Day 15, 29, 57, 85|All treated participants.|||number of participants|||Number
1441270|NCT00926263|Secondary|Serum Concentration of Fasting Glucose|Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||mg/dL||Standard Deviation|Mean
1441271|NCT00926263|Secondary|Serum Concentration of Insulin|Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||mIU/mL||Standard Deviation|Mean
1441272|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)|IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
1441273|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 2 (IGF-2)|IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
1441274|NCT00926263|Secondary|Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
1441275|NCT00926263|Secondary|Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)|IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.|Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85|All treated participants who had at least 1 postdose concentration measurement.|||ng/mL||Standard Deviation|Mean
1441276|NCT00926263|Secondary|QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours||baseline, 3 hours postdose|Data not obtained due to early termination of the study.||||||
1441277|NCT00926263|Primary|QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level|QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction|Day 1 at 1 and 24 hours post-dose, Day 7, 28|Data not obtained due to early termination of the study.||||||
1441278|NCT00926263|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).|||days||Standard Deviation|Mean
1441279|NCT00926263|Primary|Apparent Volume of Distribution (Vz)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated and evaluable participants (had measurements related to the PK parameter stated above).|||mL/kg||Standard Deviation|Mean
1441282|NCT00926263|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85|All treated participants.|||mg/L||Standard Deviation|Mean
1441284|NCT00926211|Primary|Increase in Hair Follicles Present|The increase in the number of hair follicles present at follow-up in each region compared to the number present at baseline.|Change from Baseline at 9 Months|The analysis was based on intention to treat (ITT). Imputation technique was based LOCF.|||Hair follicles||Standard Deviation|Mean
1441285|NCT00926185|Secondary|Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Baseline (Day 0) and Day 84|ITT set with LOCF was used for analysis of this outcome. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
1441286|NCT00926185|Primary|Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Day 84|Intent-to-treat (ITT) population with LOCF defined as all randomized subjects. For the efficacy analysis, the Last Observation Carried Forward (LOCF) method will be used to impute missing values.|||units on a scale||Standard Deviation|Mean
1441287|NCT00926029|Primary|Gingivitis Index|Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 Weeks||||Units on a scale||Standard Deviation|Mean
1441288|NCT00926029|Primary|Plaque Index|Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||Units on a scale||Standard Deviation|Mean
1441289|NCT00925990|Secondary|Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment|"Mean absolute changes in ALT (alanine aminotransferase)in the blood from before treatment (baseline)through 24 weeks of treatment are presented.~Mean absolute change in ALT (IU/ml)= ALT(Week 24) - ALT(baseline)"|Baseline and 24 weeks|All patients dosed with at least one dose of study drug were analyzed.|||IU/mL||Standard Deviation|Mean
1441290|NCT00925990|Primary|Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment|"Measure the mean absolute changes in HCV-RNA (Hepatitis C virus ribonucleic acid, also known as viral load) levels in the blood from before treatment (baseline) through 24 weeks of treatment.~Mean Absolute Change in HCV-RNA (log) = log10(HCV-RNA Week 24) - log10(HCV-RNA Baseline)"|Baseline and 24 weeks|All patients receiving at least one dose of study drug were analyzed for safety.|||log (IU/mL)||Standard Deviation|Mean
1441291|NCT00925938|Secondary|Percentage of Participants With Adverse Events||9 days||||Percentage of participants|||Number
1441292|NCT00925938|Secondary|Physician Assessment of Ease of Cervical Dilation;||18 - 24 hours||||percentage of participants|||Number
1441293|NCT00925938|Secondary|Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;||18 - 24 hours||||minutes||Standard Deviation|Mean
1441294|NCT00925938|Secondary|Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access||18 - 24 hours|A total of 46 subjects (90.2%) did not achieve their target dilatation after study drug removal (MVPI 400: 8 subjects; MVPI 800: 21 subjects; Placebo: 17 subjects). Forty-five subjects had additional dilatation attempted; additional dilatation was not attempted on one subject (MVPI 800) due to a protocol deviation (MVPI 800: 20 subjects).|||percentage of participants|||Number
1441295|NCT00925938|Primary|Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).||Baseline to 18-24 hours||||mm||Standard Deviation|Mean
1441296|NCT00925899|Secondary|General Fatigue Measured by the The Multidimensional Fatigue Inventory (MFI)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~The general fatigue scale that consits of four items was converted to a 0 til 100 scale where 100 indicated maximum (worst possible) fatigue.~Note outcome reported for complete compliers"|One week||||units on a scale||Standard Deviation|Mean
1441297|NCT00925899|Secondary|Appetite Loss as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Appetite loss was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum appetite loss (worst possible).~Note outcome reported for complete compliers"|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
1441686|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||mmHg||Standard Deviation|Mean
1441298|NCT00925899|Secondary|Quality of Life as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Quality of Life was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated best possible quality of life.~Note outcome reported for complete compliers"|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
1441299|NCT00925899|Secondary|Pain as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Pain was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum pain.~Note outcome reported for complete compliers"|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
1441300|NCT00925899|Secondary|Emotional Function as Measured by the Questionnaire EORTC QLQ-C15-PAL (Groenvold M, Petersen MA, Aaronson NK, et al, Eur J Cancer 42:55-64, 2006)|"Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Emotional function was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated the best possible emotional function.~Note outcome reported for complete compliers"|One week||||units on a scale||Standard Deviation|Mean
1441301|NCT00925899|Secondary|Insomnia Measured by the Insomnia Item in the Questionnaire EORTC QLQ-C15-PAL|"Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~Insomnia was converted to a 0 til 100 scale according to the scoring manual for EORTC QLQ C15-PAL where 100 indicated maximum insomnia."|One week|Complete compliers|||units on a scale||Standard Deviation|Mean
1441302|NCT00925899|Primary|Fatigue as Measured by the Physical Fatigue Scale in the The Multidimensional Fatigue Inventory (MFI) (Smets EM, Garssen B, Bonke B, et al., J Psychosom Res 39:315-325, 1995)|"Primary outcome: Change from baseline to week one in intervention group minus change from baseline to week one in control group.~Because it was a cross-over trial this was calculated the following way:~Outcomes for arm 1 (melatonin then placebo) were calculated as the difference in mean change scores between week 1 and week 2 (scores for day 7 to day 1-scores for day 17 to day 10). Outcomes for arm 2 (placebo then melatonin) were calculated as the difference in mean change scores between week 2 and week 1 (scores for day 17 to day 10-scores for day 7 to day 1).~The physical fatigue scale conists of four item each ranging from one to five. The four item were summed and the scae was converted to 0 to 100, where 100 indicated maximum fatigue."|One week|The primary analysis was a per protocol analysis including only complete compliers, defined as those patients who had consumed at least 5 capsules per week for the 2 weeks in part 1 and who had answered the MFI-20 on days 1, 7, 10, and 17.|||units on a scale||Standard Deviation|Mean
1441303|NCT00925782|Primary|Concentration-Max (Cmax)|"Cmax was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.~The Cmax results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate subsequent pharmacokinetic blood draws for the calculation of area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) for both Melphalan HCl for Injection and Alkeran for Injection.|||ng/mL||Standard Deviation|Geometric Mean
1441304|NCT00925782|Secondary|Determination of Engraftment Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"Neutrophil engraftment was defined as the first day of 3 consecutive days where ANC (absolute neutrophil count) was higher than 500/ul. The two drug treatments in this cross-over design were administered on 2 subsequent days (Day -3 and Day -2). No per arm analysis was performed.~Since the two treatments were administered consecutively with 1 day rest, the time to engraftment and engraftment rate was measured after both treatments were administered."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.|||days||Standard Deviation|Mean
1441313|NCT00925769|Secondary|Part 1: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||h*µg/mL||Standard Deviation|Mean
1441305|NCT00925782|Secondary|Determination of Myeloablation Following Melphalan-alkeran Sequence and Alkeran-melphalan Sequence Followed by ASCT|"ANC <0.5 × 109/L, absolute lymphocyte count (ALC) <0.1 × 109/L, platelet count <20,000/mm3, or bleeding requiring transfusion. The first of 2 consecutive days for which cell counts drop below these cutoff levels was recorded as the date of myeloablation.~Since the two treatments were administered consecutively with 1 day rest, the time to myeloablation and myeloablation rate was measured after both treatments were administered.~Comparison of sequence effect was not planned in the study and due to small sample size, it was not performed."|30 days|The intent-to-treat (ITT) population was defined as all patients who received at least one dose of Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection. All efficacy analyses were to be performed on the ITT population.|||days||Standard Deviation|Mean
1441306|NCT00925782|Primary|Area Under the Curve (0-t)|"AUC (0–t) was one of the pharmacokinetic endpoints to confirm pharmacokinetic similarity between Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection in patients with multiple myeloma. Pharmacokinetic similarity was defined as a difference of 20% or less in the 90% confidence intervals (CIs) for the ratios of the pharmacokinetic parameters (calculated using log-transformed data) for the two formulations.~The AUC results provided is the summary of Melphalan PK following Melphalan-Alkeran injection in Sequence 1 and Alkeran-melphalan injection in Sequence 2."|Day -3 and Day -2|"The pharmacokinetic-evaluable population was defined as all patients who completed dosing and adequate pharmacokinetic blood draws for the calculation of AUC and Cmax for both Melphalan HCl for Injection and Alkeran for Injection.~The results are presented by each drug group that combines data from both sequence."|||min*ng/mL||Standard Deviation|Geometric Mean
1441307|NCT00925769|Primary|Part 1: PRD of Bevacizumab for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/kg Q2W|||Number
1441308|NCT00925769|Primary|Part 1: PRD of Erlotinib for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/day|||Number
1441309|NCT00925769|Secondary|Part 2: Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|From baseline until death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
1441310|NCT00925769|Secondary|Part 2: Percentage of Participants With Clinical Benefit Response|Clinical benefit response was defined as a composite of pain control, Karnofsky performance status (KPS), and weight. The KPS allows participants to be classified as per their functional impairment (abnormal function). It was recorded on an 11-point scale; 0= “dead” to 100= “Normal, no complaints, no evidence of disease” and sub-divided to 3 categories; 0 to 40 = “Unable to care for self, requires institutional or hospital care or equivalent, disease may be rapidly progressing”; 50 to 70= “Unable to work, able to live at home and care for most personal needs, varying amount of assistance needed and 80 to 100= “Able to carry on normal activity; no special care is needed”.|One week before start of study treatment and weekly until disease progression or death (Up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
1441311|NCT00925769|Secondary|Part 2: Percentage of Participants With Disease Control|A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) during the assessment. As per RECIST v1.1, CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|From baseline thereafter, every 6 weeks (±7 days), then 1 week after last dose (follow-up), thereafter every 6 weeks (±7 days) until disease progression (up to Week 259)|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
1441312|NCT00925769|Secondary|Part 2: Percentage of Participants Free From Disease Progression|As per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Month 6|Data was not reported as there were no participants analyzed since Part 2 of the study was not fully implemented.||||||
1441375|NCT00925587|Secondary|Hb at Week 15||Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441314|NCT00925769|Secondary|Part 1: Last Quantifiable Drug Concentration (Clast) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||µg/mL||Standard Deviation|Mean
1441315|NCT00925769|Secondary|Part 1: Time to Reach Cmax (Tmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-DFCR and 5'-DFUR)||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||hours (h)||Full Range|Median
1441316|NCT00925769|Primary|Part 1: Preliminary Recommended Dose (PRD) of Capecitabine for Part 2|Once the MTD was reached then the preceding lower dose level was used as PRD. MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs. If MTD was not defined for a drug treatment then the maximum planned dose of that particular drug was considered as PRD for Part 2.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/m^2 BID|||Number
1441317|NCT00925769|Primary|Part 1: MTD of Bevacizumab|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/kg once every 2 weeks (Q2W)|||Number
1441318|NCT00925769|Secondary|Part 1: Maximum Serum Concentration (Cmax) of Erlotinib and Its Metabolite OSI-420 (CP373420), Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR] and 5'-Deoxy-5-Fluorouridine [5'-DFUR])||CAP: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6 hours (h) of every 2-week cycle (until Week 259) ERL: 2, 3 4, 5, 6, 7, 8, 10, 24, 28, 48, 52, 72, 76, 96, 100, 120, 124, 144, 148, 168 and 172 h of every 2-week cycle (until Week 259)|"Per-protocol population. Here n signifies the number of participants who were evaluable for each drug for each arm, respectively."|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
1441319|NCT00925769|Primary|Part 1: MTD of Erlotinib|MTD for each of the medications was defined as the lowest dose studied which resulted in DLT in at least 33% of participants of the same quality category. DLT was defined as >= G3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to AEs.|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/day|||Number
1441320|NCT00925769|Primary|Part 1: Maximum Tolerated Dose (MTD) of Capecitabine|MTD for each of the medications was defined as the lowest dose studied which resulted in dose limiting toxicity (DLT) in at least 33 percent (%) of participants of the same quality category. DLT was defined as any greater than or equal to (>=) Grade (G) 3 or G4 toxicity; >= G3 non-hematological toxicities directly related to study treatment (other than untreated nausea/vomiting, alopecia, G3/G4 bilirubinemia for less than 7 days due to edema of the ductus choledochus and anemia); G4 thrombocytopenia, neutropenia lasting >= 7 days or G3 thrombocytopenia with complications, requiring transfusions, febrile neutropenia; stopping of oral CAP and/or ERL intake for >= 7 days, and/or cancellation of one or more BEV infusion(s) due to adverse events (AEs).|Up to Week 6 (Cycle 1-3)|Per-protocol population.|||mg/m^2 BID|||Number
1441321|NCT00925704|Secondary|Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set|||hours||95% Confidence Interval|Median
1441322|NCT00925704|Secondary|Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|PK set|||pg/ml||95% Confidence Interval|Least Squares Mean
1441323|NCT00925704|Primary|Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol|This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose|Pharmacokinetic set (PK) consists of subjects who received at least 1 dose of investigational product, had evaluable serum concentration-time profiles for calcitriol through 48 hours post-dosing on Day 1 of any treatment period and did not vomit between dosing and 10 hours post-dose on Day 1 of that treatment period.|||pg*h/ml||95% Confidence Interval|Least Squares Mean
1441376|NCT00925587|Secondary|Hb at Week 13||Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441324|NCT00925600|Other Pre-specified|Number of Participants With Adverse Events|"Adverse events (AEs) were assessed for severity by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) severity grading scale, version 3.0, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 =Life-threatening AE and Grade 5 = Death due to AE.~Treatment-related AEs (TRAEs) include only events for which the investigator indicated there was a reasonable possibility they may have been caused by the study drug."|12 months|All enrolled participants who received at least one dose of study drug. Three participants randomized to the placebo group who received at least 1 dose of denosumab in error are analyzed in the denosumab group for safety.|||participants|||Number
1441325|NCT00925600|Other Pre-specified|Change From Baseline in Refraction Needed to Achieve BCVA|Refraction error was measured using a phoropter. The change from baseline in spherical refraction error needed to achieve BCVA is reported.|Baseline and months 3, 6, 9, and 12|"Lens opacification analysis set with evaluable assessments at both baseline and each time point in the same eye.~n=the number of evaluable eyes in the lens opacification analysis set at the corresponding time point; 3 participants randomized to placebo who received denosumab in error are analyzed in the denosumab group."|||diopters|eyes|Standard Deviation|Mean
1441326|NCT00925600|Other Pre-specified|Percentage of Participants With a Decrease From Baseline in Best Corrected Visual Acuity (BCVA) of ≥ 10 Letters|"The best corrected visual acuity (BCVA) is the best vision one can achieve with correction (such as eye glasses) as measured on an eye chart. BCVA was assessed by a trained ophthalmologist using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at 4 meters. The modified University of Crete ETDRS chart was used in Ukraine, Greece, Russia and Bulgaria, which do not use the Roman alphabet. The 2000 series revised ETDRS chart was used to assess the change in all other countries.~The letter score was calculated based on the number of letters that were correctly identified; higher letter scores correspond to better visual acuity."|Baseline and Months 3, 6, 9 and 12|"Lens opacification analysis set with evaluable assessments at both baseline and the time point of interest in the same eye (as indicated by n). Three participants randomized to placebo who received at least 1 dose of denosumab in error are analyzed in the denosumab group."|||percentage of participants|||Number
1441327|NCT00925600|Other Pre-specified|Percentage of Participants With Confirmed Lens Opacification Event Development or Progression by Month 12|"The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity.~Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline. A confirmed lens opacification event development or progression was defined as 2 directly subsequent events per protocol assessments at the same location (P, C, NO) using LOCS III as above."|12 months|"Lens opacification analysis set with at least two post-baseline LOCS III measurements by month 12.~Three participants randomized to placebo who received at least 1 dose of denosumab in error are analyzed in the denosumab group."|||percentage of participants|||Number
1441328|NCT00925600|Other Pre-specified|Percentage of Participants With Lens Opacification Event Development or Progression by Month 6|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 6 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.|6 months|Lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site at or before month 6. Three participants randomized to placebo who received denosumab in error are analyzed in the denosumab group.|||percentage of participants|||Number
1441329|NCT00925600|Other Pre-specified|Percentage of Participant With Lens Opacification Event Development or Progression by Month 12 Based on a Change of ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III Score|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change ≥ 1.5 in P, ≥ 1.5 in C, or ≥ 1.5 in NO in the LOCS III score from baseline.|12 months|The lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site. Three participants randomized to placebo who eceived ≥ 1 dose of denosumab in error are analyzed in the denosumab group.|||percentage of participants|||Number
1441342|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441343|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441330|NCT00925600|Primary|Percentage of Participants With Lens Opacification Event Development or Progression by Month 12|The Lens Opacities Classification System III (LOCS III) is a slit lamp based opacification grading method. Photographs of slit lamp cross-sections of the lens are used as references for grading nuclear opalescence (NO) and nuclear color (NC), and photographs of the lens seen by retroillumination are used as references for grading cortical (C) and posterior subcapsular (P) cataract. Opacification severity is graded on a decimal scale, scores can range from 0.1 to 6.9 for NO and NC and from 0.1 to 5.9 for C and P. For each opacification type the higher grading scores indicate greater severity. Lens opacification event development or progression by month 12 was based on a change of ≥ 1.0 in P, ≥ 1.0 in C, or ≥ 0.7 in NO in the LOCS III score from baseline.|12 months|The lens opacification analysis set includes randomized participants who received ≥1 dose of study drug, had an evaluable baseline and at least 1 evaluable post-baseline LOCS III assessment at the corresponding lens site. Three participants randomized to placebo who received ≥ 1 dose of denosumab in error are analyzed in the denosumab group.|||percentage of participants|||Number
1441331|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Evaluation Period|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441332|NCT00925587|Secondary|Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)||Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||Weeks||Inter-Quartile Range|Median
1441333|NCT00925587|Secondary|Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 1-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441334|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441335|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441336|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441337|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441338|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441339|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441340|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441341|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441639|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|6 months||||pg/ml||Standard Deviation|Mean
1441344|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441345|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441346|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441347|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441348|NCT00925587|Secondary|Ratio of Darbepoetin Alfa Dose to Baseline at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||ratio||95% Confidence Interval|Geometric Mean
1441349|NCT00925587|Secondary|Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Weeks 29-33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441350|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 31|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441351|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 29|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441352|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 27|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441353|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 25|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441354|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 23|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441355|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 21|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441356|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 19|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441357|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 17|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441358|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 15|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 15|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441359|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 13|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 13|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441360|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 11|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441361|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 9|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441362|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 7|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441363|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 5|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441364|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 3|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441365|NCT00925587|Secondary|Darbepoetin Alfa Dose at Week 1|Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period|Week 1|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||µg/wk||95% Confidence Interval|Geometric Mean
1441366|NCT00925587|Secondary|Hb at Week 33||Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441367|NCT00925587|Secondary|Hb at Week 31||Week 31|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441368|NCT00925587|Secondary|Hb at Week 29||Week 29|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441369|NCT00925587|Secondary|Hb at Week 27||Week 27|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441370|NCT00925587|Secondary|Hb at Week 25||Week 25|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441371|NCT00925587|Secondary|Hb at Week 23||Week 23|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441372|NCT00925587|Secondary|Hb at Week 21||Week 21|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441373|NCT00925587|Secondary|Hb at Week 19||Week 19|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441374|NCT00925587|Secondary|Hb at Week 17||Week 17|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441377|NCT00925587|Secondary|Hb at Week 11||Week 11|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441378|NCT00925587|Secondary|Hb at Week 9||Week 9|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441379|NCT00925587|Secondary|Hb at Week 7||Week 7|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441380|NCT00925587|Secondary|Hb at Week 5||Week 5|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441381|NCT00925587|Secondary|Hb at Week 3||Week 3|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441382|NCT00925587|Secondary|Hb at Baseline||Baseline|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||Standard Error|Mean
1441383|NCT00925587|Secondary|Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.||Baseline to Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||Percentage of Participants||95% Confidence Interval|Number
1441384|NCT00925587|Primary|Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)|The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.|Baseline Week 33|Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)|||g/dL||95% Confidence Interval|Least Squares Mean
1441385|NCT00925548|Secondary|Serum Carcinoma Antigen (CA) 15-3 Levels|CA 15-3 is a serum marker for breast cancer which is a possible measure for immune response.|Baseline, Week 5, 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441386|NCT00925548|Secondary|Number of Participant Utilizing Healthcare Resources|Healthcare Resource Utilization (HRU) parameters included direct medical resources (e.g., nonscheduled procedures, unplanned hospitalization, outpatient visits), nonmedical resources (e.g., travel, paid and unpaid assistance), and occupational resources (e.g., occupational changes and concerns).|Randomization up to end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441387|NCT00925548|Secondary|European Questionnaire-5 Dimensions (EQ-5D) Questionnaire|EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were to be converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00. Higher scores on the EQ-5D represent a better quality of life (QoL) and lower scores on the EQ-5D represent a worst QoL.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441388|NCT00925548|Secondary|Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire|FACT-B questionnaire consists of 36 questions; 7 in physical well-being (PWB); 7 in social well-being (SWB); 6 in emotional well-being (EWB); 7 in functional well-being (FWB); 9 in breast cancer subscale (BCS). Trial outcome Index (TOI) was calculated by the sum of the physical well-being (PWB), functional well-being (FWB), and breast cancer scale (BCS) subscales of FACT-B. Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier. Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.|Baseline, Week 9, 20, 32, 44 and end of trial visit|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441389|NCT00925548|Secondary|Time to Chemotherapy|Time to chemotherapy is defined as the time from date of randomization to the start date of chemotherapy.|Time from randomization to start of chemotherapy, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441390|NCT00925548|Secondary|Time to Progression (TTP)|TTP is defined as the time from date of randomization to the date of radiological diagnosis of PD (censoring for death without progression).|Time from randomization to PD, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).||||||
1441444|NCT00924898|Secondary|Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment|Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization|At enrollment||||Participants|||Count of Participants
1441391|NCT00925548|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit is defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or stable disease (SD,) lasting for at least 22 weeks.|Randomization until the date of first documented progression assessed up to end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441392|NCT00925548|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441393|NCT00925548|Secondary|Percentage of Participants With Objective Tumor Response|Percentage of participants with objective tumor response was to be reported. An objective response (OR) was defined as a participant having a best overall response of either confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST 1.0) as assessed by independent radiological review.|Randomization until the date of first documented progression, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441394|NCT00925548|Secondary|Overall Survival (OS) Time|OS time was defined as the time from randomization to death. Participants without event were to be censored at the last date known to be alive or at the clinical cut-off date, whichever was earlier.|Time from randomization to death or last day known to be alive reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not analyzed as the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25)||||||
1441395|NCT00925548|Primary|Progression-Free Survival (PFS)|PFS was defined as the duration from randomization to first observation of progressive disease (PD) as confirmed by the independent radiological review or death.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized i.e. 30 Sep 2009, until end of trial i.e. 27 Aug 2010|Data were not collected as no independent read took place, due to low numbers: the trial was prematurely terminated following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).||||||
1441396|NCT00925522|Secondary|Chronic Success is Defined at 6 Months Following the RF Ablation Procedure as no Recurrence of Clinically Relevant VT(s) That Were Targeted at Ablation.|Summarized as the number of subjects with recurrence of clinically relevant VT(s) that were targeted at ablation at 6 months following the RF ablation procedure|6 months||2017-08-31|08/2017||||
1441397|NCT00925522|Primary|Acute Success is Achieved When All Clinically Relevant VT Substrates (Spontaneous and Induced VT Episodes) Are Terminated and no Longer Inducible Upon Hospital Discharge (i.e., Last Study Ablation Procedure Prior to Hospital Discharge).|Summarized as number of subjects with clinically relevant VT substrates (spontaneous and induced VT episodes) that are terminated and no longer inducible upon hospital discharge - from the last study ablation procedure prior to hospital discharge.|Hospital Discharge||2017-08-31|08/2017||||
1441398|NCT00925522|Primary|Primary Safety is Defined as the Incidence of Intra-procedural, Acute or Sub-chronic, Serious Cardiac Adverse Events, up to 7 Days Post-procedure.||7 days||||participants|||Number
1441399|NCT00925353|Secondary|Frequencies of Moderate, Severe, or Life-threatening Side Effects|Percentages of study subjects exhibiting moderate, severe, or life-threatening signs and symptoms at each of the eight time measurements|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after|||||||
1441400|NCT00925353|Secondary|Variation of Heart Rate (Bpm), Respiratory Rate (Respirations Per Minute, Rpm), Systolic Blood Pressure (mm Hg), and Diastolic Blood Pressure (mm Hg) Over Time.|Variation of heart rate (bpm), respiratory rate (respirations per minute, rpm), systolic blood pressure (mm Hg), and diastolic blood pressure (mm Hg) over time was assessed using generalized linear mixed models with time modeled as a fixed effect and study subject modeled as a random effect.|Prior to gel application and at 30 min, 60 min and 2, 3, 4, 6. and 8 hours after|||||||
1441401|NCT00925353|Secondary|EKG Changes|The PR interval (msec), QRS duration (msec), and QTc interval (msec) were compared between the baseline and subsequent EKG using paired t-tests.|Prior to gel application and 3 hours after|||||||
1441402|NCT00925353|Primary|Pharmacokinetic Parameters Based on Plasma Concentration of Lidocaine and MEGX in Nanograms/Milliliter.|Plasma concentration of lidocaine and MEGX in nanograms/milliliter were measured prior to one-time application of 4% lidocaine gel on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography, and at 30 minutes, 60 minutes, and 2, 3, 4, 6, and 8 hours. Due to the high frequency of nondetectable values, pharmacokinetic parameters could not be estimated. Measurements at all time points were grouped together to select a median.|Prior to gel application, and at 30 min, 60 min, and 2, 3, 4, 6, and 8 hours after|Plasma lidocaine and MEGX levels were measured prior to lidociane gel application, and at 30 min, 60, min, and 2, 3, 4, 6, and 8 hours after on 10 subjects (total of 80 lidocaine levels and 80 MEGX levels). Minimum level of detection for lidocaine and MEGX was 200 ng/mL.|||nanograms/mililiter|Participants|Full Range|Median
1441403|NCT00925288|Secondary|Identify Barriers to Acceptance of HPV Vaccine Among Female Sex Workers|Listed doubts about the HPV vaccine. Participants were asked if they had any doubts about the vaccine prior to learning about it from the health professional. Herein we present the total number of participants who reported doubts by study arm.|Month 0|All participants who listed doubts about the vaccine are counted here.|||participants|||Number
1441404|NCT00925288|Secondary|Prevalence of Infection With HPV Subtypes (6,11,16,18) Among Female Sex Workers|Type specific prevalence of HPV6,11,16,18 among study participants, calculated using Linear Array testing.|Baseline|All participants were included in the analysis for baseline HPV DNA prevalence|||participants|||Number
1441445|NCT00924898|Secondary|Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications|Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization|At enrollment||||Participants|||Count of Participants
1441405|NCT00925288|Primary|Proportion of Female Sex Workers Who Complete the Three Dose (0, 2, 6 Month) HPV Schedule in a Timely Manner Compared to the Modified (0, 3, 6 Month) Schedule.|Completion of 3 doses of HPV4 vaccine was measured at 6 months for women receiving the vaccine in 0,2,6 month regimen or the modified 0,3,6 month regimen. Completion was measured as receiving dose 3 of the vaccine during the study.|6 months|All participants were included|||participants|||Number
1441406|NCT00925288|Primary|Antibody Response to HPV Vaccine for HPV 6,11,16,18.|We measured anitbody response to HPV vaccine for HPV subtypes 6,11,16, and 18. This was compared by study arm, namely the regular and modified vaccination schedules.|Month 7|All participants who returned for the final blood draw considered in the final antibody analysis. The analysis applies to antibody levels after vaccination for HPV6, HPV11, HPV16, and HPV18. This is done for each study arm, namely the regular schedule and the modified schedule.|||Milli Merck Units||95% Confidence Interval|Geometric Mean
1441407|NCT00925132|Secondary|Phase 2 - Number of Participants With Disease Progression|Number of participants who died or had disease progression|5 years|Number patients who received study drug in Phase II portion of trial|||Participants|||Count of Participants
1441408|NCT00925132|Primary|Phase 2 -Number of Patients With a Decrease in Tumor Size Using RECIST and CHOI's Criteria|"Tumor response rate was assessed using RECIST criteria in which a complete response was the disappearance of all target lesions; Partial response was a 30% decrease in the sum of the longest dimension (LD) of target lesions, relative to baseline measurement; Progressive disease was an increase of 20% or more in the sum of the LD of target lesions; and Stable disease was a decrease in tumor size of less than 30% or increase of less than 20%.~Tumor response rate was also assessed using CHOI's criteria in which a response was a 10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced computed tomography scan.~Tumor response rates were assessed in order to determine effectiveness of the treatment regimen which was defined by the response rate of at least 30% as measured by either the RECIST or Choi’s criteria, and ineffective if the rate is less than 15% on both."|12 weeks (2 cycles)|Number of patients evaluable for tumor response assessment following 2 cycles of treatment|||Participants|||Count of Participants
1441409|NCT00925132|Primary|Phase I - Number of Participants With Dose Limiting Toxicities (DLTs) at a Given Dose Level|"A DLT was any Grade 4 toxicity for neutrophils or platelets for ≥ 7 days, Grade 3 toxicity for neutrophils for ≥ 21 days, any Grade 3 solid organ toxicity not explainable by another cause (e.g. neurotoxicity, GI toxicity), metabolic/laboratory toxicity (≥10 x ULN AST) for ≥ 14 days, any Grade 4 infection or QTcF> 500msec EKG. DLTs were assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.~All adverse events were collected and graded to determine DLTs as assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. DLTs were assessed to determine the recommended Decitabine and Panobinostat dose for the Phase II portion of the trial."|6 weeks (one full cycle)|Number of patients within the 4 dosing cohorts evaluable for DLTs following administration of one full cycle|||Participants|||Count of Participants
1441410|NCT00925119|Secondary|Change in Insulin|fasting insulin (post - pre atenolol)|Baseline and Week 8||||mU/mL||Standard Deviation|Mean
1441411|NCT00925119|Secondary|Change in HDL||Baseline and Week 8||||mg/dL||Standard Deviation|Mean
1441412|NCT00925119|Secondary|Change in Glucose Effectiveness|Glucose effectiveness as measured by insulin-modified IV glucose tolerance test using the MINMOD model.|Baseline and Week 8|Data could not be determined because assumptions for MINMOD model were not met.||||||
1441413|NCT00925119|Secondary|Change in Insulin Sensitivity|"As measured by the Homeostatic model assessment of insulin resistance (HOMA2-IR) (post atenolol - pre atenolol).~he Homeostatic model assessment (HOMA) is a method for assessing insulin sensitivity from fasting glucose and insulin. A higher HOMA value indicates higher insulin resistance. The widely-used formulae available for HOMA1 provide only linear approximations of HOMA_%B and HOMA_IR, the inverse of HOMA_%S. These are: HOMA1_IR = [FPI (uU/ml) x FPG (mmol/l) ]/22.5 HOMA1_%B = (20 x FPI)/(FPG - 3.5) The results obtained for HOMA2 may differ considerably from HOMA1 computer-calculated values, especially for more extreme glucose and insulin values. For this reason, no attempt has been made to provide linear approximations of HOMA2 calculated values of HOMA_%B, HOMA_IR and HOMA_%S. The software needed to calculate HOMA2 values is available on this website: https://www.dtu.ox.ac.uk/homacalculator/download.php, subject to the conditions specified on the downloads page."|Baseline and Week 8|Post and Pre atenolol data available in 17 subjects|||arbitrary units||Standard Deviation|Mean
1441414|NCT00925119|Secondary|Change in Triglycerides|(Post atenolol triglycerides - Pre atenolol triglycerides)|Baseline and Week 8|Data available in 17 subjects|||mg/dL||Standard Deviation|Mean
1441415|NCT00925119|Primary|Change in Free Fatty Acid Kinetics|Estimate of peripheral lipolysis using modeling of free fatty acid levels collected during an IV glucose tolerance test. The change in threshold for insulin action (post-atenolol minus pre-atenolol) is the primary variable from this modeling that we analyzed.|Baseline and Week 8|Modeling data not available in all subjects|||mU/mL||Standard Deviation|Mean
1441416|NCT00925119|Primary|Change in Diastolic Function (Annular Tissue Velocity [Em])||8 weeks|Data were not able to be collected from the echocardiography.||||||
1441417|NCT00925015|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|Approximately 4 weeks after last drug treatment (up to Day 293)|Participants treated with study medication.|||Participants|||Number
1441418|NCT00925015|Secondary|AUC0-24 of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The AUC0-24 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8 and 24 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1441419|NCT00925015|Secondary|Vss of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Vss of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/m^2||Geometric Coefficient of Variation|Geometric Mean
1441420|NCT00925015|Secondary|CL of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The CL of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/h/m^2||Geometric Coefficient of Variation|Geometric Mean
1441421|NCT00925015|Secondary|T1/2 of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The T1/2 of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29..|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Geometric Coefficient of Variation|Geometric Mean
1441422|NCT00925015|Secondary|Cmax of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Cmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1441423|NCT00925015|Secondary|Tmax of Irinotecan Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Irinotecan was administered with an intravenous infusion of 150 mg/m^2 once every other week on Days 1, 15, and 29. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Cetuximab was administered on Days 1, 8, 15, 22, 29 and 36. The Tmax of plasma Irinotecan was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 1, 5, 8, 24, and 48 h after completion of Irinotecan infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Full Range|Median
1441424|NCT00925015|Secondary|AUC0-168 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-168 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1441425|NCT00925015|Secondary|AUC0-24 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The AUC0-24 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8 and 24 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1441426|NCT00925015|Secondary|Vss of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Vss of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/m^2||Geometric Coefficient of Variation|Geometric Mean
1441446|NCT00924898|Secondary|Number of Participants With HIV RNA Suppression at Week 96|Number of participants wtih HIV RNA level <50 copies/mL at week 96|HIV RNA level at 96 weeks following enrollment||||Participants|||Count of Participants
1441427|NCT00925015|Secondary|CL of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The CL of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mL/h/m^2||Geometric Coefficient of Variation|Geometric Mean
1441428|NCT00925015|Secondary|T1/2 of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The T1/2 of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Geometric Coefficient of Variation|Geometric Mean
1441429|NCT00925015|Secondary|Cmax of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Cmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1441430|NCT00925015|Secondary|Tmax of Cetuximab Following Administration of Cetuximab / Irinotecan Alone, or in Combination With 10 mg/kg Dalotuzumab|In Cycle 1 Cetuximab was administered with an initial intravenous infusion of 400 mg/m^2 on Day 8, followed by subsequent once weekly intravenous infusions of 250 mg/m^2 on Days 15, 22, 29 and 36. In the same Cycle 1 Dalotuzumab 10 mg/kg was administered on Days 22, 29 and 36; and Irinotecan was administered on Days 1, 22, and 29. The Tmax of plasma Cetuximab was determined alone on Day 15 and in combination with dalotuzumab on Day 29.|Cycle 1: Day 15 and Day 29 at predose, 2, 5, 8, 24, 48, 96 and 168 h after initiation of cetuximab infusion|Participants from the Cetux/Irin - Dmab 10 mg/kg arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Full Range|Median
1441431|NCT00925015|Secondary|Area Under the Concentration-time Curve From 0-168 Hours Post-dose (AUC0-168) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-168 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1441432|NCT00925015|Secondary|Area Under the Concentration-time Curve From 0-24 Hours Post-dose (AUC0-24) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The AUC0-24 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8 and 24 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1441433|NCT00925015|Secondary|Steady-state Volume of Distribution (Vss) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Vss of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
1441447|NCT00924898|Secondary|Number of Participants Without Virologic Failure at Week 48|HIV RNA level <50 copies/mL at week 48|HIV RNA level at week 48 following enrollment||||Participants|||Count of Participants
1441448|NCT00924898|Primary|Number of Participants Without Virologic Failure at Week 24|Number of participants with a HIV RNA level <200 copies/mL at week 24|HIV RNA level prior to or at week 24 following enrollment||||Participants|||Count of Participants
1441449|NCT00924833|Secondary|Mean 24 Hour/Daytime/Night-time Blood Pressure and Heart Rate||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
1441434|NCT00925015|Secondary|Clearance From Plasma (CL) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The CL of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||mL/min/kg||Geometric Coefficient of Variation|Geometric Mean
1441435|NCT00925015|Secondary|Apparent Terminal Half-life (T1/2) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The T1/2 of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Geometric Coefficient of Variation|Geometric Mean
1441436|NCT00925015|Secondary|Maximum Concentration (Cmax) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Cmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1441437|NCT00925015|Secondary|Concentration at the End of Infusion (Ceoi) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Ceoi of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1441438|NCT00925015|Secondary|Time to Maximum Concentration (Tmax) of Dalotuzumab Following Administration of 10 mg/kg Dalotuzumab Alone in or in Combination With Cetuximab / Irinotecan|In Cycle 1 Dalotuzumab was administered on Days 1 and 22 as an intravenous infusion at 10 mg/kg. In the same Cycle 1 Cetuximab was administered on Days 8, 15, 22 and 29; and Irinotecan was administered on Days 8 and 22. The Tmax of plasma Dalotuzumab alone was determined on Day 1, and in combination with cetuximab/irinotecan on Day 22.|Cycle 1: Day 1 and Day 22 at predose, 0.5 h after start of infusion, end of infusion, 5, 8, 24, 30, 48, 96 and 168 h after initiation of dalotuzumab infusion|Participants from the Dmab 10 mg/kg - Cetux/Irin (DDI) arm only, who were treated with study medication and had evaluable measurements at baseline and at least once during treatment. No explicit imputation was made for missing data.|||h||Full Range|Median
1441439|NCT00925015|Secondary|Number of Participants With Human Anti-Human Antibody (HAHA)|Sera were collected from participants prior to administration of the first dose of study drug, every 6 weeks during the study period, then 4 weeks, 8 weeks and 12 weeks post-treatment. A sandwich format enzyme-linked immunosorbent assay (ELISA) was used to detect the presence of HAHA in serum.|Up to 12 weeks after the last administration of dalotuzumab (up to 349 days)|All treated participants, excluding those without measurable data.|||Participants|||Number
1441440|NCT00925015|Primary|Number of Dose-limiting Toxicities (DLTs)|To be declared a DLT an adverse experience had a causality related to study therapy. DLTs could be adverse experiences possibly, probably, or definitely related to study therapy by the Investigator, and included the following : Grade 4 neutropenia lasting >= 5 days; Grade 3 or 4 neutropenia with fever >38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except inadequately treated diarrhea, nausea and vomiting, rash, hyperglycemia, and transient abnormality of electrolytes. Anemia, infusion reactions, hypersensitivity reactions, and adverse experiences not-related to study therapy did not qualify as DLTs.|Four weeks of Cycle 1 treatment (up to 28 days)|Participants treated with study medication. The Dmab 10 mg/kg - Cetux/Irin arm was not evaluated. In the Cetux/Irin - Dmab 10 mg/kg (DDI) arm two participants were not analyzed because one had febrile neutropenia (Grade 3) before the first treatment, and the second had a skin toxicity (Grade 3) before the DLT evaluation period.|||DLT|||Number
1441441|NCT00924950|Secondary|To Determine the Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion.||Between Week 4 and Week 6|||||||
1441442|NCT00924950|Primary|Difference in Change Between Baseline and Week 4 Modified Psoriasis Area Severity Index (PASI) Scores in Targeted Plaques Treated With Taclonex Under Occlusive Dressing Versus Taclonex Alone.|Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.|Between Baseline and Week 4|The number of participants was chosen by our budget restrictions|||Units on a scale||95% Confidence Interval|Mean
1441443|NCT00924898|Secondary|Time to HIV RNA Suppression <50 Copies/mL|Number of days from ART initiation to HIV RNA suppression <50 copies/mL|Number of days from start of study treatment until HIV RNA suppression, assessed through week 96||||days||Full Range|Median
1441452|NCT00924833|Primary|Delta Peak Exercise Minute Ventilation Time 1 Versus Time 3.|"Difference in peak exercise minute ventilation between Time 1 and Time 3 (Time 3 - Time 1.~Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)."|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||L/min||Standard Deviation|Mean
1441453|NCT00924833|Secondary|Systolic Pulmonary Artery Pressure.||Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
1441454|NCT00924833|Secondary|Peak Exercise Oxygen Saturation|Oxygen saturation by pulse oxymetry at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||2009-12-31|12/2009||||
1441455|NCT00924833|Primary|Peak Exercise Minute Ventilation|Minute ventilation at peak of exercise. Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||L/min||Standard Deviation|Mean
1441456|NCT00924833|Primary|Delta Peak Exercise Oxygen Consumption Time 1 Versus Time 3|Difference in peak exercise oxygen consumption between Time 1 and Time 3 (Time 3 - Time 1)|Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||ml/Kg/min||Standard Deviation|Mean
1441457|NCT00924833|Primary|Peak Exercise Oxygen Consumption|Oxygen consumption at peak of exercise|Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment.||||ml/Kg/min||Standard Deviation|Mean
1441458|NCT00924807|Secondary|Biochemical Disease-free Survival|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|after 9 months|||||||
1441459|NCT00924807|Primary|Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."|Day 29 and every 2 weeks|"Data of zero (0) participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study."||||||
1441460|NCT00924781|Secondary|Change From Baseline in Hg Level at Week 12||12 weeks|Full analysis set; due to study termination participants in the MK2578 1mcg/350U QW and MK2578 1mcg/350U QM were not analyzed.|||g/dL||Standard Deviation|Mean
1441461|NCT00924781|Primary|Number of Participants With Confirmed, Treatment Emergent Antibodies to MK2578||12 weeks|Immunogenicity assays for antibodies to MK2578 were not performed due to early study termination.||||||
1441462|NCT00924781|Primary|Number of Participants With Events of Death, MI, CVA, Peripheral Vascular Thromboses, Vascular Access Thrombosis, Congestive Heart Failure (CHF), Hypertension, Seizure, or Pure Red Cell Aplasia||12 weeks||||Participants|||Number
1441463|NCT00924781|Primary|Number of Participants With Composite Events of Infusion Reactions||12 weeks||||Participants|||Number
1441464|NCT00924781|Primary|Number of Participants With Composite Events of Transfusion-Related Adverse Experiences||12 weeks||||Participants|||Number
1441465|NCT00924781|Primary|Number of Participants With Composite Events of Death, Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)||12 weeks||||Participants|||Number
1441466|NCT00924781|Primary|Change From Baseline in Hemoglobin (Hg) Level at Week 4||4 weeks|Full analysis set|||g/dL||Standard Deviation|Mean
1441467|NCT00924729|Secondary|Disk Diffusion Assay of Collected Aqueous Humor|A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.|Approximately 3-4 months.|The amount of aqueous concentration of antibiotic agent was not enough to perform a secondary analysis||||||
1441468|NCT00924729|Primary|Aqueous Humor Concentration of Study Drug|Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.|approximately 3 to 4 months||||µg/ml||Standard Deviation|Mean
1441469|NCT00924651|Primary|Change of Cancer-related Fatigue as Assessed by the Brief Fatigue Inventory (BFI) Total Score at Day 41 (After Exercise Intervention) Minus BFI Total Score at Day 0 (Before Exercise Intervention)|"BFI has nine items. Three items ask patients to rate the severity of their fatigue at its “worst,” “usual,” and “now” during normal waking hours, with 0 being “no fatigue” and 10 being “fatigue as bad as you can imagine.” Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0–10 scale, with 0 being “does not interfere” and 10 being “completely interferes.” BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue).~The outcome measure is the change in the Brief Fatigue Inventory Total Score at day 41 (after exercise intervention) minus Brief Fatigue Inventory Total Score at day 0 (before exercise intervention)."|41 days: Day 0 (before intervention) Day 41 (post intervention)|Subjects completing both BFI at day 0 and day 41|||units on a scale||Standard Deviation|Mean
1441489|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set|||g/cm^2||Standard Error|Least Squares Mean
1441470|NCT00924638|Secondary|Impact of Patient Assistant Use on AF Diagnosis|AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency|Follow-up closure|Number of subjects in the Continuous Monitoring arm who had AF detected by the Insertable Cardiac Monitor (ICM) during the course of the study|||days from AF occurrence to AF diagnosis||Standard Deviation|Mean
1441471|NCT00924638|Secondary|Clinical Disease Burden and Care Pathway|Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months|12 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
1441472|NCT00924638|Secondary|Health Outcome as Evaluated by EQ-5D Questionnaire|EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).|12 months|Number of subjects who reported EQ-5D VAS score at the 12 months visit|||units on a scale of 0 to 100||Standard Deviation|Mean
1441473|NCT00924638|Secondary|Use of Antiarrhythmic Drugs|Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12 months follow-up visit|||percentage of participants|||Number
1441474|NCT00924638|Secondary|Use of Oral Anticoagulation (OAC) Drugs|Percentage of subjects who were using OAC drugs at the 12 months follow-up visit|12 months|Number of subjects who completed the 12-months follow-up visit|||percentage of participants|||Number
1441475|NCT00924638|Secondary|Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)|Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
1441476|NCT00924638|Secondary|AF Detection Rate Within 12 Months|Percentage of subjects with AF detected within 12 months of follow-up|12 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
1441477|NCT00924638|Primary|AF Detection Rate Within 6 Months|Percentage of subjects with AF detected within 6 months of follow-up|6 months|Intention-to-treat (ITT) population (all randomized subjects)|||percentage of participants|||Number
1441478|NCT00924560|Secondary|Number of Participants With Adverse Events (AEs)|"An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.~A severe AE is defined as incapacitating, with inability to perform usual activities.~A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:~fatal or life-threatening;~required or prolonged inpatient hospitalization;~resulted in persistent or significant disability/incapacity;~congenital anomaly or birth defect;~important medical event."|12 months|The safety analysis set includes data from all randomly assigned participants who received at least 1 dose of study treatment and from all participants enrolled in the control group who had baseline BMD measures via DXA. One participant randomly assigned to 91-day LNG received 21-day LNG instead and is included in the 21-day LNG group for safety.|||participants|||Number
1441479|NCT00924560|Secondary|Change From Baseline in Serum Type I Collagen N-telopeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||nM bone collagen equivalents (BCE)||Standard Deviation|Mean
1441480|NCT00924560|Secondary|Change From Baseline in Serum Procollagen 1 N-terminal Propeptide||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||µg/L||Standard Deviation|Mean
1441481|NCT00924560|Secondary|Change From Baseline in Serum Osteocalcin||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||nmol/L||Standard Deviation|Mean
1441482|NCT00924560|Secondary|Change From Baseline in Serum Deoxypyridinoline||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||nmol/L||Standard Deviation|Mean
1441483|NCT00924560|Secondary|Change From Baseline in Bone-specific Alkaline Phosphatase||Baseline, Month 6 and Month 12|"Per protocol analysis set with Baseline data available; participants with available data at each time point are indicated by n."|||µg/L||Standard Deviation|Mean
1441484|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."|||g||Standard Error|Least Squares Mean
1441485|NCT00924560|Secondary|Change From Baseline in Total Body Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with Baseline total body DXA scans. Participants with available total body DXA scans at each time point are indicated by n."|||g/cm^2||Standard Error|Least Squares Mean
1441486|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."|||g||Standard Error|Least Squares Mean
1441487|NCT00924560|Secondary|Change From Baseline in Proximal Femur Bone Mineral Density|Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|"Per-protocol analysis set with available Baseline proximal femur DXA scans; participants with available proximal femur DXA scans at each time point are indicated by n."|||g/cm^2||Standard Error|Least Squares Mean
1441488|NCT00924560|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Content (BMC)|Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists.|Baseline, Month 6 and Month 12|Per-protocol analysis set|||g||Standard Error|Least Squares Mean
1441490|NCT00924560|Primary|Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD)|"Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.~Percent change from Baseline was calculated as (BMD at Month 12 – BMD at Baseline)/BMD at Baseline * 100%."|Baseline and Month 12|Per-protocol analysis set, including all participants who received at least 1 dose of study treatment (does not apply to Control group), had both Baseline and one post-baseline assessment via DXA, and who completed all procedures at all scheduled study visits including the 12-month DXA scans, and did not have any major protocol violations.|||percent change||Standard Error|Least Squares Mean
1441491|NCT00924508|Secondary|Number of Adverse Events Associated With Treatment||6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.|||Adverse events|||Number
1441492|NCT00924508|Primary|Change in Disease Severity: Percent Change in Mean EASI Score|Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.|Baseline, 6 weeks|3 of 23 enrolled participants withdrew consent and did not provide data for analysis. Each participant had 3 lesions treated in the study, one by each of 3 study treatments.|||percentage change|Participants|Full Range|Mean
1441493|NCT00924482|Primary|Comparison of ECOM Impedance and Thermodilution Cardiac Output Measurements|"Correlation measured via Linear regression between thermodilution and ECOM, included as r^2 coefficient.~Cardiac output measured by iced-thermodilution and impedance cardiography. Management of the patients done using (standard) thermodilution derived cardiac output measurements only. The ECOM endotracheal cardiac output measurements are for research purposes only and not used in the management of the patient.~ECOM Impedance cardiography measured in the ICU when routine thermodilution cardiac output measurements are made. Endotracheal impedance measurements (ECOM) continued until tracheal extubation. Correlation with thermodilution measurements stopped when either the endotracheal tube or the thermodilution catheter was removed (post op day 0 routinely)."|perioperative period|Results are for the final n=101 who had the approved clinical electronics and clinical tube; no changes in tube, algorithm or electronic design were made during this part of the study. Experimental electronics and version of the tube were used to test and finalize the design and algorithm during enrollment of the earlier patient group.|||liters/min||Standard Deviation|Mean
1441494|NCT00924482|Secondary|Safety of Device Measured by Number of Participants With Adverse Events|Patients were interviewed postoperatively for all complications and specifically for complications related to intubation and/or cardiac output measurements|perioperative period||||participants|||Number
1441495|NCT00924469|Primary|Dihydrotestosterone (DHT) Concentration in Prostate Tissue|The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
1441496|NCT00924469|Secondary|Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment|Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.||||||
1441497|NCT00924469|Secondary|Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24|Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.|Week 24|Resullts were not reported due to insufficient data in this outcome measure.||||||
1441498|NCT00924469|Secondary|Percentage of Participants With Pathologic Complete Response (CR)|Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Percentage of participants|||Number
1441499|NCT00924469|Secondary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.|Weeks 12 and 24|ITT population included all the participants who were randomly assigned to the study treatment.|||Percentage of participants|||Number
1441500|NCT00924469|Secondary|Serum Levels of Androgens|Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."|||Nanogram per deciliter (ng/dL)||Standard Deviation|Mean
1441512|NCT00924352|Secondary|Incidence of Grade 4 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||participants|||Number
1452621|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 03 (Week 6; 42 +/- 3 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1441501|NCT00924469|Secondary|Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue|Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.|Week 12 and 24|"ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
1441502|NCT00924469|Secondary|Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.|Week 24|ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
1441503|NCT00924469|Primary|Testosterone Concentration in Prostate Tissue|Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.|Week 12|Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Picogram per milligram (pg/mg)||Standard Deviation|Mean
1441504|NCT00924443|Secondary|Duration of Complete Remission|Duration was calculated by Kaplan- Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of participants who achieved CR+CRi only|||days||95% Confidence Interval|Median
1441505|NCT00924443|Secondary|Overall Survival|Calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.|||days||95% Confidence Interval|Median
1441506|NCT00924443|Secondary|Duration of Overall Response|Duration was calculated by Kaplan-Meier estimates|From 20 months up to 48 months|The analysis were performed on the primary analysis population, the Full Analysis Set population. Defined as the median duration of overall response (CR+CRi+PR) in participants who achieved CR, CRi or PR only|||days||95% Confidence Interval|Median
1441507|NCT00924443|Secondary|Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial)|"Response was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment.~Response was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analyses were performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.|||percent of participants||95% Confidence Interval|Number
1441508|NCT00924443|Primary|Overall Response Rate (ORR)|"ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population.~ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment."|At month 20|The efficacy analysis was performed on the primary analysis population, the Full Analysis Set population, which consisted of all participants with a diagnosis of AML confirmed by the Investigator who received at least one dose (partial or complete) of clofarabine.|||percentage of participants||95% Confidence Interval|Number
1441509|NCT00924404|Secondary|Mean Number of Antibiotic Courses During the Study Period|Mean Number of antibiotic courses for infection during the study period|12 weeks||||mean number of antibiotic courses during||Standard Deviation|Mean
1441510|NCT00924404|Primary|SNOT-20 Scores at 12 Weeks|"Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues.~Symptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent “as troublesome as possible”. The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100."|12 weeks|We initially enrolled 53 subjects but we had 10 subjects drop out of the study.|||units on a scale||Standard Deviation|Mean
1441511|NCT00924352|Primary|Evaluation of Progression-free Survival (PFS) of the Combination of Dasatinib and Ixabepilone (Phase II)|Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.|PFS was measured from day 1 of treatment until time of progression (assessed about every 8 weeks) or death, whichever came first, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||months||95% Confidence Interval|Median
1452622|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 02 (Week 4; 28 +/- 3 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1441513|NCT00924352|Secondary|Incidence of Grade 3 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)|All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||participants|||Number
1441514|NCT00924352|Secondary|Clinical Benefit Rate of the Combination of Dasatinib and Ixabepilone (Phase II)|Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks (from the start of treatment) plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of >=20%.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.||||percentage of participants|||Number
1441515|NCT00924352|Secondary|Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)|Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.|The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.|||participants|||Number
1441516|NCT00924352|Primary|Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I)|DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose limiting toxicity was defined as any grade 4 hematologic event or any grade 3 or 4 non-hematologic event occurring during cycle 1 that is attributable to dasatinib, ixabepilone, or the combination. The following events were excluded from this definition: grade 4 neutropenia lasting for 3 days or less; grade 3 nausea responsive to antiemetics; grade 3 infection with normal ANC or grade 1 or 2 neutrophils; grade 3 diarrhea responsive to optimal use of antidiarrheal therapy.|DLTs were assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.|||participants|||Number
1441517|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I)|The MTD of ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) when given in combination with dasatinib (taken daily, continuously) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.|||mg/m2|||Number
1441518|NCT00924352|Primary|Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I)|The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.|MTD was assessed during the first cycle of combination therapy (days 1-28).|The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.|||mg daily|||Number
1441519|NCT00924313|Secondary|11C-Acetate Standardized Uptake Value (SUV)Max and Serum Prostate Specific Antigen (PSA) Levels Using Spearman Correlation|Tumor foci was histopathologically identified and tested to determine SUVmax relative to PSA levels. PSA normal range is 0-4ng/mL.|2 years|One patient was not imaged because of failed tracer synthesis.|||SUVmax||Standard Deviation|Mean
1441520|NCT00924313|Secondary|Lesion Based Sensitivity Analysis Using Positron Emission Tomography (PET)/Computed Tomography (CT), Multi-parametric Magnetic Resonance Imaging (MP-MRI), Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI), and DCE-MRI.|PET/CT, MP-MRI, DW-MRI, and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) were used to detect lesion sensitivity.|2 years|One patient was not imaged because of failed tracer synthesis.|||percentage of sensitivity||95% Confidence Interval|Number
1441521|NCT00924313|Secondary|Standardized Uptake Value (SUV) of Grouping Tumors Based on Gleason Score|Intensity [11C]AC uptake with histopathologic Gleason grade were done with a Spearman rank correlation following prostatectomy. Two biopsies were performed and graded according to tumor pattern. The two grades were added together for a final Gleason score. Gleason score equal to or less than 3+4 is considered low risk. Gleason score equal to or greater than 4+3 is considered high-risk.|2 years|One patient was not imaged because of failed tracer synthesis.|||SUV||Standard Deviation|Mean
1441522|NCT00924313|Secondary|Incidence of Extraprostatic Lesions Accumulating [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Detection|Suspicious lesions noted on biopsy were compared with standard care imaging diagnostic modalities, additional biopsies, and/or clinical follow up performed at the discretion of the referring physician.|2 years|One patient was not imaged because of failed tracer synthesis.|||Participants|||Count of Participants
1441640|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||pg/ml||Standard Deviation|Mean
1441523|NCT00924313|Secondary|Count of Participants With Physiological Effects of [11C]AC|Buildup of positron emission tomography (PET) radiopharmaceuticals excreted by the urinary system can accumulate in the bladder and limit pelvic imaging. This effect contributes to low physiologic distribution in the pelvis.|2 years|One patient was not imaged because of failed tracer synthesis.|||Participants|||Count of Participants
1441524|NCT00924313|Secondary|Pelvic Biodistribution of [11C]AC Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging|Pelvic biodistribution was obtained for the prostate tumor, normal prostate and benign prostatic hyperplasia (BPH). Uptake is expressed in standardized uptake value (SUV).|2 years|One patient was not imaged because of failed tracer synthesis.|||SUV||Standard Deviation|Mean
1441525|NCT00924313|Secondary|Diagnostic Accuracy of the Standardized Uptake Value of [11C]AC Obtained Using Positron Emission Tomography (PET)/Computed Tomography (CT) for Detecting Region (Sextant)-Specific Malignancy Using Receiver Operating Curves (ROC) for a Lesion >0.9cm|The diagnostic accuracy of 11C-Acetate PET/CT imaging in prostate cancer was compared with multi-parametric magnetic resonance imaging (MP-MRI) using sector based analysis, generating receiver-operating-characteristic (ROC) curves (plots of 1-specificity versus sensitivity) for both modalities.|2 years|One patient was not imaged because of failed tracer synthesis.|||Percentage ROC curve||95% Confidence Interval|Number
1441526|NCT00924313|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years||||Participants|||Count of Participants
1441527|NCT00924313|Primary|Compare the Biodistribution of 11C-acetate Positron Emission Tomography (PET)/Computed Tomography (CT) Imaging in Tumor and Non Tumorous Regions of the Prostate|Standard uptake values (SUV) measurements of 11C-acetate will be obtained in each sextant (e.g. region) on each patient. Sextant-specific malignancy will be determined pathologically based on a subsequent prostatectomy. Initially, on each patient, we will, average SUV measurements in tumor and non-tumor regions (i.e., sextants with malignancy and no malignancy, respectively). The patient average SUV measurements across tumors and non-tumor regions will then be compared using a paired t-test.|2 years|One patient was not imaged because of failed tracer synthesis.|||ng/mL||Standard Deviation|Mean
1441528|NCT00924287|Secondary|Number of Participants With In Vivo Survival of Transfused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|12 days||||Participants|||Number
1441529|NCT00924287|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 days||||Participants|||Number
1441530|NCT00924287|Primary|Number of Participants With an Objective Clinical Tumor Regression Response|Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 days|||||||
1441531|NCT00924209|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|38 months||||Participants|||Number
1441532|NCT00924209|Primary|Rate of Pathologic Complete Response|Complete response is defined as a disappearance of all target lesions and was assessed by the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.|25 weeks|No goals were met because of low accrual for which the study was closed.||||||
1441533|NCT00924170|Secondary|Count of Participants With Adverse Events Attributed At Least Possibly to Patients Treated With Fludarabine and Cyclophosphamide Dose Levels 20+200, 25+250, and 30+300 mg/m^2|Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 12 days|*Grade 5 (death) event. Data for this outcome measure is reported as in the publication noted in the References module.|||Participants|||Count of Participants
1441534|NCT00924170|Secondary|Count of Participants With Grades 3-5 Adverse Events of > 1 Adult T-Cell Leukemia (ATL) Patients Treated With 20+200, 25+250, and 30+300 mg/m^2 LMB-2/Fludarabine and Cyclophosphamide|Adverse events is assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 (mild), Grade 4 (life threatening) and Grade 5 (death).|7 years and 12 days|Data for this outcome measure is reported as in the publication noted in the References module.|||Participants|||Count of Participants
1441535|NCT00924170|Secondary|Half Life (t1/2) of LMB-2|Dilutions of patient plasma was tested by cytotoxicity assays to determine half life. Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||min||Full Range|Median
1441536|NCT00924170|Secondary|Volume of Distribution of LMB-2|Dilutions of patient plasma were tested by cytotoxicity assays to determine volume of distribution of LMB-2. Volume distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. This was measured during the first 24 hours after administration of the dose on cycle 2 day 1.|24 hours|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||Liters||Full Range|Median
1441537|NCT00924170|Secondary|Plasma Clearance (CL) of LMB-2|Dilutions of patient plasma was tested by cytotoxicity assays to determine plasma clearance of LMB-2.The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||mL/min||Full Range|Median
1441538|NCT00924170|Secondary|Duration of Response (Complete Response + Partial Response)|Duration of response is defined as a response lasting for at least 4 weeks but >8 weeks and is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion.|69 months||||Weeks||95% Confidence Interval|Median
1441539|NCT00924170|Secondary|Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2|Blood was drawn prior to each cycle of LMB-2 to determine if the level, >75% neutralization of 1000ng/ml of LMB-2 of neutralizing antibodies is too high to give additional LMB-2. Analysis was performed by cytotoxicity assay.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||percentage of participants||95% Confidence Interval|Number
1441540|NCT00924170|Secondary|Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry|Peripheral blood was obtained and analyzed by flow cytometry.|First 24 hours after the dose given on Cycle 2, day 1|One patient did not have flow cytometry measuring it.|||Cells/µL||Full Range|Median
1441541|NCT00924170|Secondary|Area Under the Plasma Concentration (AUC) - LMB2|AUC is a measure of the plasma concentration of drug over time. It is used to characterize drug absorption. Plasma levels were analyzed by cytotoxicity assay.|First 24 hours after the dose given on Cycle 2, day 1|Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2|||µg/-min/mL||Full Range|Median
1441542|NCT00924170|Secondary|Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders|Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.|First 24 hours after the dose given on Cycle 2, day 1|The number 8 represents the number of responders in the Arm/Group and the number 2 represents the number of non-responders in the Arm/Group.|||pg/ml||Full Range|Median
1441543|NCT00924170|Secondary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to <grade II within 2 weeks is considered DLT. Hematologic toxicity is not considered DLT unless it fails to resolve to <grade 2 or baseline by day 18 after cycle 1 or after day 25 after cycles 2-7. DLT from hepatotoxicity, creatine phosphokinase, and vascular leak syndrome is assumed from LMB-2, and hematologic toxicity from fludarabine and cyclophosphamide. Grade III proteinuria lasting <2 weeks after the last dose of LMB-2 is not considered DLT, and needs to resolve to grade 0-2 prior to retreatment.|30 days after last dose of LMB2||||Participants|||Count of Participants
1441544|NCT00924170|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 12 days||||Participants|||Count of Participants
1441545|NCT00924170|Secondary|Overall Survival (OS)|OS is the time between the first day of treatment to the day of disease progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|70 months|One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2.|||Months||95% Confidence Interval|Median
1441546|NCT00924170|Secondary|Progression Free Survival (PFS)|PFS was determined by the Kaplan Meier method beginning at the on study date and continuing until progression or last follow-up without progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|70 months||||Months||95% Confidence Interval|Median
1441547|NCT00924170|Secondary|Peak Level of LMB-2 in Adult T-Cell Lymphoma|The maximum analyte concentration in serum was reported using a cytotoxicity assay measuring the level of LMB-2 in the plasma and using purified LMB-2 as a standard curve.|First 24 hours after the dose given on Cycle 2, day 1||||ng/mL||Full Range|Median
1441641|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Tumor Necrosis Factor-alpha)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||pg/ml||Standard Deviation|Mean
1441548|NCT00924170|Primary|Percentage of Participants With a Minimally Durable Clinical Response Rate|Response is based on the International Workshop to Standardize Response Criteria for Non-Hodgkin’s Lymphoma and must last >8 weeks to meet the primary endpoint of the study. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. Stable disease is neither a response nor progressive disease. Progressive disease is appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count.|8 weeks|"All 10 patients receiving LMB-2 and at least 25+250 mg/m^2 Fludarabine/Cyclophosphamide (FC) were evaluable for response.~Of the 8 other patients, only 5 received LMB-2 and were therefore evaluable for response."|||percentage of participants||95% Confidence Interval|Number
1441549|NCT00924118|Secondary|Left Ventricular Infarct Size|Left ventricular infarct size by Magnetic Resonance Imaging (MRI). Calculated percentage of the left ventricular mass by MRI that has undergone infarction.|4-5 days following enrollment|Only 2 participants from each arm underwent MRI imaging. Too few subjects underwent MRI imaging to make a statistical comparison. Only those where data was obtained has been reported.|||infarct percentage of left ventricle||Full Range|Mean
1441550|NCT00924118|Primary|Ischemia Area at Risk as Determined by Paired Single-photon Computed Tomography Studies With Technetium Tc99m Sestamibi.|Measured as percentage of left ventricle|4-5 days from enrollment|Sestamibi imaging proved impossible to obtain emergently and therefore no data was collected.||||||
1441551|NCT00924066|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|61 months|Adverse events are grouped together because the histology cohort has no bearing on the adverse events.|||participants|||Number
1441552|NCT00924066|Primary|Tumor Response (PR + CR) Per RECIST|Establish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.|Every 6 weeks, up to 15 months||||participants|||Number
1441553|NCT00924053|Primary|Vz/F|Apparent volume of distribution|3 days||||mL||Standard Deviation|Mean
1441554|NCT00924053|Primary|CL/F|The apparent rate of oral clearance of EGT0001474.Oral clearance was defined as rate of drug removal from the body after oral administration.|3 days||||mL/hr||Standard Deviation|Mean
1441555|NCT00924053|Primary|t1/2|Apparent terminal half life|3 days||||hour||Standard Deviation|Mean
1441556|NCT00924053|Primary|λz|Terminal phase rate constant|3 days||||1/hour||Standard Deviation|Mean
1441557|NCT00924053|Primary|Tmax|Time of maximum plasma concentration|3 days||||hour||Full Range|Median
1441558|NCT00924053|Primary|Cmax|Maximum plasma concentration|3 days||||ng/mL||Standard Deviation|Mean
1441559|NCT00924053|Primary|AUC Inf|Area under the plasma concentration-time curve from time 0 to infinity|3 days||||ng*hr/mL||Standard Deviation|Mean
1441560|NCT00924053|Primary|AUC0-24|Area under the plasma concentration-time curve from time 0 to hour 24|3 days||||ng*hr/mL||Standard Deviation|Mean
1441561|NCT00924053|Primary|AUC 0-t|Area under the plasma concentration-time curve from time 0 to time t|3 days||||ng*hr/mL||Standard Deviation|Mean
1441562|NCT00924053|Primary|Safety and Tolerability of EGT0001474|Safety and tolerability were measured in terms of the number of mild, moderate and severe adverse events experienced by any participants.|25 days|All patients who took study medication were included in the analysis.|||Events|||Number
1441563|NCT00924040|Secondary|Percentage of Patients Who Have Dose Limiting Toxicity (DLT)|Determination of dose limiting toxicity (DLT) is by the standard toxicity assessment Common Terminology Criteria for Adverse Events version 3.0 (CTCAEv3.0) done every cycle. For detailed information about the CTCAEv3.0 see the protocol Link module.|24 weeks||||Percentage of participants|||Number
1441564|NCT00924040|Secondary|Percentage of Patients Who Make Antibodies|Determination of antibodies against BL22 is determined by the Clinical Laboratory Improvement Amendments (CLIA) certified blood tests in our contract lab. NCI-Frederick in the laboratory of Dr. David Waters (Science Applications International Corporation (SAIC). He is CLIA certified.|24 weeks||||Percentage of participants|||Number
1441565|NCT00924040|Secondary|Correlation Between Number of Prior Cycles of BL22 With Immunogenicity on This Protocol|Percent of patients neutralizing >75% of 1000 ng/ml of BL22 in a biologic assay by end of treatment, with respect to the number of prior cycles of BL22 prior to entry on this protocol|Within 2 months of end of treatment ( measure antibodies before each cycle)||||correlation coefficient|||Number
1441566|NCT00924040|Secondary|Percentage of Patients Who Respond Clinically, Who Also Have Normalization in sCD22 or sCD25|CD25 (sCD25)and CD22 (sCD22) quantify hairy cell leukemia (HCL) tumor burden. Patients with either PR or CR are evaluated for soluble forms of CD25 (sCD25) and soluble CD22 (sCD22). The number of patients with PR or CR who have normalization of sCD25 and sCD22 will be recorded. Normalization is considered <3 ng/ml for sCD25, and <2 ng/ml for sCD22. Patients will be assessed for normalization of sCD25 and sCD22 for at least 12 months after achieving PR or CR.|patients may undergo lymphapheresis before the first and/or later cycles up to 12 months after achieving CR or PR||||Percentage of participants|||Number
1441642|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|1 year||||μg/mL||Standard Deviation|Mean
1441567|NCT00924040|Secondary|Number of Patients With ex Vivo Sensitivity Who Respond Clinically|Although some hairy cell leukemia (HCL) cells from some patients may have ex vivo sensitivity, they might not respond clinically. Number of participants with pretreatment ex vivo sensitivity (<10 ng/ml IC50) who go on to achieve CR as best response. CR required abscence of HCL in the bone marrow and resolution of cytopenias.|Time to CR can be between 2 months and 1 year||||Participants|||Number
1441568|NCT00924040|Secondary|Number of Patients Who Developed Neutralizing Antibodies After One or More Cycles of BL22|Fresh malignant cells are isolated from blood, bone marrow, lymph nodes or other tissue and incubated with recombinant immunotoxins to determine sensitivity to BL22 and other agents to estimate the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood.|24 weeks||||Participants|||Number
1441569|NCT00924040|Secondary|Number of Participants With Complete Response (CR) Who Resolve the Bone Marrow Abnormality by Magnetic Resonance Imaging (MRI)|Patients are assessed by MRI to determine which ones resolve their marrow abnormality. A non-parametric Wilcoxon test was to be used to determine whether CR correlated with resolution of MRI abnormality|Bone marrow biopsy and MRI 4 weeks after patients meeting blood criteria for CR, and if CR is present, repeat bone marrow biopsy and MRI every 12 months. Bone marrow biopsy and MRI is not done in patients with PR as best response.||||Participants|||Number
1441570|NCT00924040|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|2 years & 6 months||||Participants|||Number
1441571|NCT00924040|Primary|Number of Months to Response to Treatment|Response is defined by the Response Evaluation Criteria in the protocol, namely the earliest point where all relevant tests (i.e. lab tests, physical exam, radiology results) are consistent with complete response (CR) or partial response (PR). CR or PR must be confirmed for at least 4 weeks. Complete response: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. Partial response:neutrophils >/= 1,500/micrograms/L or 50% improvement over baseline without growth factors for at least 4 weeks.|2/14/2009 till 6/24/2010||||Months|||Number
1441572|NCT00924001|Secondary|Number of Participiants With In-vivo Survival of Infused Cells|In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).|44 days||||Participants|||Number
1441573|NCT00924001|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|44 days||||Participants|||Number
1441574|NCT00924001|Primary|Number of Participants With an Objective Clinical Tumor Regression Response According to RECIST Criteria|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progression (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|44 days||||Participants|||Number
1441575|NCT00923975|Primary|Number of Participants Out of 50 Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks|"Study staff rated participants on their success at performing specific tasks. The rating scale was:~= Successful ( no assistance)~= Successful after staff prompted to view user instructions~= Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call)~= Unsuccessful (Subject could not perform the task)~= Subject could not perform task due to software or hardware failure after repeated attempt."|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.|||participants|||Number
1441576|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)|"Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale:~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.|||participants|||Number
1441577|NCT00923975|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)|"After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale.~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|The number of results analyzed was less than 50 because some subjects had no opinion. One subject had no opinion of clarity of online help overall and three subjects had no opinion of usefulness of online help overall.|||participants|||Number
1441578|NCT00923975|Secondary|Number of Participants Out of 50 Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:~= Very Simple~= Simple~= Neither Simple nor Difficult~= Difficult~= Very Difficult"|1-2 hours|One subject was withdrawn from the study and the data was not used in the analysis. The subject did not meet inclusion criteria.|||participants|||Number
1441579|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Serum Tumor Markers|C-reactive protein, cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA-125) and carcinoembryonic antigen (CEA) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
1441580|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Histologically Normal Tissue Biomarkers|ki-67 and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
1441643|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||μg/mL||Standard Deviation|Mean
1441581|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Premalignant Tissue Biomarkers|Premalignant tissue biomarkers ki-67, apoptotic index and peroxisome proliferator-activated receptor gamma (PPARgamma) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
1441582|NCT00923949|Secondary|Number of Participants With Metabolic Activity Determined by Fludeoxyglucose Positron-emission Tomography (FDG-PET)|Response will be evaluated by FDG-PET. Response is defined as a decrease of standardized uptake values (SUV) of more than one.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
1441583|NCT00923949|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|58 days||||Participants|||Number
1441584|NCT00923949|Secondary|Number of Participants With Effects of Pioglitazone on Multiple Biomarkers in Tumor|Apoptotic index (A1) will be assessed by terminal deoxynucleotidyl transferase dUTP end labeling (TUNEL) and cyclin D1, p21/Waf1, PPARy, MUC1, gelsolin, proline oxidase, and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
1441585|NCT00923949|Primary|Number of Participants With a Change in Ki-67 Due to the Effect of Pioglitazone in Tumor Tissue|Antigen ki-67 (Ki-67) will be assessed by immunohistochemistry.|58 days|No participants were analyzed because only one participant went on study and he did not undergo the requisite lung cancer resection due to disease progression, which means there was insufficient tissue to perform all the secondary tumor marker analyses. There is no statistical power to draw any conclusions and thus the data are not informative.||||||
1441586|NCT00923936|Secondary|Percentage of Participants With 12- Month Progression-free Survival (PFS)|Participants who survived and were progression free for 12 months. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Progressive disease is an increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters) of the marker lesions or a change in character from macular to plaque-like or nodular of at least 25% of the lesions or new visceral sites of involvement or progression of visceral disease or the development of new or increasing tumor-associated edema or effusion that lasts at least 1 week and interfered with the patient's normal activities.|12 months||||percentage of participants||95% Confidence Interval|Number
1441587|NCT00923936|Secondary|Median Number of Cycles Need to Obtain a Partial Response|Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) and noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1; no new lesions occurring in previously uninvolved areas of the body; no new visceral sites of involvement or the appearance or worsening of tumor-associated edema or effusions and a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or complete flattening of at least 50% of all previously raised lesions (i.e., 50% of all previously nodular or plaque-like lesions become macular) lasting for at least 4 weeks.|6 cycles, an average of 18 weeks||||Cycles||95% Confidence Interval|Median
1441588|NCT00923936|Secondary|Count of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|7 years and 6 months and 21 days||||Participants|||Count of Participants
1441589|NCT00923936|Secondary|Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab|Complete response rate is the fraction of subjects with an complete response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. In patients whom pigmented macular skin lesions persist after apparent complete response, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having a clinical complete response.|6 cycles, an average of 18 weeks|No patients had a complete response.|||percentage of participants||80% Confidence Interval|Number
1441603|NCT00923845|Secondary|Count of Patients With Chronic Graft Versus Host Disease (GVHD)|Chronic GVHD was assessed by the 2005 Chronic GVHD Consensus Project. Chronic GVHS may include dryness of the mouth and eyes, weight loss, liver damage and lung damage leading to cough and shortness of breath (i.e. skin Grading: no symptoms = 0, <18% body surface area (BSA) = 1, 19-50% BSA = 2, and >50% BSA = 3); oral cavity Grading: no symptoms = 0, mild symptoms = 1, moderate symptoms =2 and severe symptoms =3)).|For the duration of post-transplant follow-up|Only 4 patients were evaluable due to mortality from malignancy.|||Participants|||Count of Participants
1441644|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (C-reactive Protein)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||μg/mL||Standard Deviation|Mean
1441590|NCT00923936|Primary|Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS.|Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) & noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.|6 cycles, an average of 18 weeks||||percentage of participants||80% Confidence Interval|Number
1441591|NCT00923910|Secondary|Number of Participants With Progressive Disease|Progressive disease is at least a 20% increase in the sum of the longest diameter of all target lesions (i.e. tumor response). Response criteria for acute leukemia's is worse marrow classification (i.e., M status) with at least a 50% increase in the percentage of marrow blasts, or no change in marrow classification (i.e., M status), but a 50% or greater increase in absolute peripheral blast count or extent of medullary disease|4 to12 weeks|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
1441592|NCT00923910|Secondary|Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)|KLH is a neoantigen known to induce helper response was used concurrently as a vaccine adjuvant and control antigen. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
1441593|NCT00923910|Secondary|Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)|WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
1441594|NCT00923910|Secondary|Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot)|WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control.|48 to 72 hours after placement|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
1441595|NCT00923910|Secondary|Time to Immune Response|Immune response was monitored by use of interferon gamma Enzyme-Linked Immunospot (ELISpot) and by delayed-type hypersensitivity (DTH) testing.|4 to 12 weeks|The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||Weeks|||Number
1441596|NCT00923910|Primary|Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3|Acute Graft versus Host Disease (GVHD) was graded by the modified Glucksberg scale. 0 = no GVHD normal, 4 = severe GVHD.|28 days following completion of last vaccine and/or DLI (donor lymphocyte infusion) administration|Data for the frequency and severity of GVHD was captured as an endpoint for this trial. The donor arm is not included here because they were not evaluated for this outcome measure; recipients only.|||participants|||Number
1441597|NCT00923910|Primary|Toxicity|Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module.|21 months|Only recipients were monitored for adverse events.|||participants|||Number
1441598|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))|CD4+ T cells were analyzed by flow cytometry for intracellular expression of FoxP3.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4+ T cells||Full Range|Median
1441599|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet|CD4+ T cells were analyzed by flow cytometry for intracellular detection of Tbet transcription factor.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4+T cells||Full Range|Median
1441600|NCT00923845|Secondary|Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)|Intra-cellular flow cytometry detection of GATA3 transcription factor.|Days 14, 60 and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4+ T cells||Full Range|Median
1441601|NCT00923845|Secondary|Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution|CD8+ T Cells immune reconstitution is defined as distribution of CD8+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percent of total CD8 cell subsets||Standard Deviation|Median
1441602|NCT00923845|Secondary|Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution|CD4 T Cells immune reconstitution is defined as distribution of CD4+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.|Days 14, 60, and 100 post transplant|The values for each subset were stable at days 60 and 100 relative to day 14 values.|||Percentage of total CD4 cell subsets||Standard Deviation|Median
1452623|NCT00833690|Secondary|Serum Urate|From blood sample drawn after taking study drug that day|Visit 01 (Week 2; 14 +/- 3 days after Baseline Visit)||||mg/dL||Standard Deviation|Mean
1441604|NCT00923845|Secondary|Count of Patients With Late Acute Graft Versus Host Disease (GVHD) After Day 100 Post-Transplant|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).|100 days post-transplant through 5 years post-transplant|Only 6 patients were evaluable for this endpoint due to death due to malignancy.|||Participants|||Count of Participants
1441605|NCT00923845|Secondary|Count of Patients With Grade II or Greater Acute Graft Versus Host Disease (GVHD) in First 100 Days Post-Transplant|Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).|100 days post transplant||||Participants|||Count of Participants
1441606|NCT00923845|Secondary|Engraftment Donor T Cell and Myeloid Cell Chimerism|Donor Genetic Elements by variable number tandem repeat-polymerase chain reaction (VNTR-PCR) Analysis.|Days 14, 28, 45, and 60 post transplant||||Percent Donor by VNTR-PCR Analysis||Full Range|Median
1441607|NCT00923845|Secondary|Immune Suppression|Immune suppression is defined by the frequency of elimination of a pre-transplant T cell cytokine value.|Cytokine analysis at baseline and within 24 hours of completion of the pentostatin/cyclophosphamide regimen||||% of undetectable cytokine measurements|||Number
1441608|NCT00923845|Secondary|Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells|Reduction in cluster of differentiation 8 (CD8)+ T cells [change in median values and (range of values)].|Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)||||cells/µL||Full Range|Median
1441609|NCT00923845|Secondary|Immune Depletion in Cluster of Differentiation 4 (CD4) Cells|Reduction in cluster of differentiation 4 (CD4)+ T cells [change in median values and (range of values)].|Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)||||Cells/µL||Full Range|Median
1441610|NCT00923845|Secondary|Count of Patients Having an Infectious Complication Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen|Occurrence of infection by Common Terminology Criteria for Adverse Events (CTCAE).|During the 21-day PC regimen||||Participants|||Count of Participants
1441611|NCT00923845|Secondary|Count of Patients Having Neutropenia Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen|Absolute neutrophil count determination by complete blood count methodology (Absolute Neutrophil Count (ANC) < 500 Cells/µL).|During the 21-day PC regimen||||Participants|||Count of Participants
1441612|NCT00923845|Secondary|Count of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|50 months and 6 days||||Participants|||Count of Participants
1441613|NCT00923845|Primary|Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))|Response was assessed by computed tomography measurements and the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest LD recorded since the treatment started or the appearance of one or more new lesions.|6 Months Post-Transplant (Day +100)||||participants|||Number
1441614|NCT00923481|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|23 months||||Participants|||Number
1441615|NCT00923481|Primary|Response Rate|Response is assessed by the RECIST (response criteria in solid tumors)criteria. A complete response (CR) is disappearance of all target lesions , partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|24 months||||Participants|||Number
1441616|NCT00923364|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|91 months|Data were not collected separately for donors and recipients.|||Participants|||Count of Participants
1441617|NCT00923364|Secondary|Number of Participants With Disease Free Survival|Number of participants with documented evidence of disease progression following start of treatment.|2 years|10/19 analyzed:5pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||Participants|||Count of Participants
1441618|NCT00923364|Secondary|Overall Survival|Overall survival is defined as date of on-study to date of death from any cause or last follow up.|2 years|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||months||Full Range|Median
1441636|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||ng/ml||Standard Error|Mean
1441637|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||ng/ml||Standard Deviation|Mean
1441619|NCT00923364|Secondary|Incidence of Acute and Chronic Graft-versus-host Disease (GVHD)|Acute GVHD is assessed according to the 1994 Consensus Conference Grading Criteria. Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. GVHD can affect performance status and attack multiple organ systems such as the skin, liver, gut, mouth, eyes, joints, lung, etc. that can lead to a rash, diarrhea, metabolic changes, infection and/or death. The clinical grading of acute GVHD is grade 0 (none) to 4 (severe). Chronic GVHD is a delayed form of GVHD that may occur after day 100 post transplant.|2 years|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||participants|||Number
1441620|NCT00923364|Secondary|Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)|Engraftment of donor cells was assessed using polymorphisms in regions known to contain short tandem repeats. Peripheral blood cluster of differentiation 14 (CD14+), cluster of differentiation 3 (CD3-)/cluster of differentiation 56 (CD56+), cluster of differentiation 19 (CD19+), and CD3+ subsets were isolated by flow cytometry and chimerism was assessed.|2 years|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||percentage of donor cells||Full Range|Mean
1441621|NCT00923364|Primary|Days to Platelet Engraftment|Platelet engraftment is defined as a platelet count of >20 x 10(9) cells/L for 7 consecutive days without requiring a platelet transfusion.|30 days|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||Days||Full Range|Median
1441622|NCT00923364|Primary|Days to Neutrophil Engraftment|Neutrophil engraftment is defined as a neutrophil count of >0.5 x 10(9) cells/L for 3 consecutive days.|30 days|10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant & 3 pts had early deaths (before outcome measurements could be evaluated)|||Days||Full Range|Median
1441623|NCT00923351|Primary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|Time between the first day of treatment to the day of death or at the conclusion of 5 years of follow-up, whichever comes first, assessed up to approximately 11 years.||||years||Full Range|Median
1441624|NCT00923351|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|Date treatment consent signed to date off study, approximately 49.5 months||||Participants|||Count of Participants
1441625|NCT00923351|Primary|Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay|"A positive response to the tumor vaccine requires a positive reaction in at least one of the two assays below (immune responses to tumor lysates using ex vivo and delayed type of hypersensitivity (DTH).~The presence of a positive delayed type of hypersensitivity (DTH) reaction to the tumor lysate in a patient who did not show a positive DTH reaction prior to immunotherapy. A positive reaction is induration of at least 0.5 cm.~Immunotherapy administered to patients with recurrent or metastatic pediatric solid tumors such as Ewing's sarcoma, rhabdomyosarcoma, or neuroblastoma. Each vaccine is given as 6 separate injections. Three intradermal on one arm or leg and three subcutaneous on the other arm or leg."|Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (± 7 days) (Arm B)|Five of the original six participants from Arm A were analyzed because one subject was changed to a special exemption.|||Participants|||Count of Participants
1441626|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Sirolimus|The phase I component of the study are to determine the safety and tolerability of sirolimus in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks||||mg/m^2|||Number
1441627|NCT00923273|Primary|Phase II: Clinical Response Rate|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|21 weeks|By formal criteria in the protocol, DL4 exceeds the MTD, and DL 3 would be expanded by 3 subjects to confirm it's tolerability. We believe that DL4 is safe, and that the observed DLTs at this DL are related to enrollment of a subject with a borderline performance status, and the omission of defining length of neutropenia as a DLT.|||Participants|||Number
1441628|NCT00923273|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|45 months||||Participants|||Number
1441629|NCT00923273|Primary|Phase I: Maximum Tolerated Dose (MTD) of Pemetrexed|The phase I component of the study are to determine the safety and tolerability of pemetrexed in human subjects with non small cell lung cancer (NSCLC), and to determine the maximum tolerated dose.|5 weeks||||mg/m^2|||Number
1441630|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||ng/ml||Standard Deviation|Mean
1441631|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||ng/ml||Standard Deviation|Mean
1441632|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||ng/ml||Standard Deviation|Mean
1441633|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Adiponectin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||ng/ml||Standard Deviation|Mean
1441634|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||ng/ml||Standard Deviation|Mean
1441635|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Leptin)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||ng/ml||Standard Deviation|Mean
1441687|NCT00923260|Primary|Components of Metabolic Syndrome (Systolic Blood Pressure)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||mmHg||Standard Deviation|Mean
1441688|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 year||||Kg/m2||Standard Deviation|Mean
1441689|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|6 months||||Kg/m2||Standard Deviation|Mean
1441690|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|3 months||||Kg/m2||Standard Deviation|Mean
1441691|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|1 month||||Kg/m2||Standard Deviation|Median
1441692|NCT00923260|Secondary|Acute Phase Reactants and Inflammatory Mediators (Interleukine-6)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement|Basal||||pg/ml||Standard Deviation|Mean
1441693|NCT00923260|Primary|Components of Metabolic Syndrome (Body Mass Index)|Absolute values are presented, a basal value is provided in a previous outcome measure to determine the improvement.|Basal||||Kg/m2||Standard Deviation|Mean
1441694|NCT00923247|Secondary|Comparison of Steady State Vandetanib Exposure With Relevant Literature Values|"Because vandetanib PK exposure was only measured during a single 8-hr window during daily dosing, the only comparison to assess the effect of bortezomib is to compare these values to published literature."|Cycle 3 day 1 (an average of 60 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|Vandetanib PK samples were only obtained during the phase 1 portion of the study during cycle 3, day 1, where patients received both vandetanib (at steady-state) and bortezomib. “13/14 patients analyzed on day 61 (C3D1). Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||ng/mL/mg||Standard Deviation|Mean
1441695|NCT00923247|Secondary|Bortezomib Volume of Distribution (Vss)|Vss represents the volume into which the drug distributes into once given to the patient at steady-state. This volume parameter provides a measure of where in the body the drug is going, based on fluid volume.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||Liter||95% Confidence Interval|Geometric Mean
1441696|NCT00923247|Secondary|Total Systemic Clearance (CL) of Bortezomib|Total systemic clearance = dose/area under curve extrapolated to infinity (AUCinf.). This measurement represents the rate at which plasma is systematically cleared of drug.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||L/hr||95% Confidence Interval|Geometric Mean
1441697|NCT00923247|Secondary|Terminal Half-Life (T1/2) of Bortezomib|The time it takes for the measured concentration of the drug to drop by half.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||hour||95% Confidence Interval|Geometric Mean
1441698|NCT00923247|Secondary|Area Under the Bortezomib Plasma Concentration Versus Time Curve From Time Zero to Infinity/Dose (AUCinf/D)|The area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf) was calculated using the linear up-log down trapezoidal method via extrapolation of AUC(LAST) (AUC to the last quantifiable time point) by dividing C(LAST) (the last measurable drug concentration, typically at 24 hour post-dose) by the rate constant of the terminal phase, lambda z. This constant was determined from the slope of the terminal phase of the concentration-time curve using weighted least-squares as the estimation procedure.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post dose|PK samples were only done during the phase I portion of the study. “7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.” Please see other outcome measure modules for details.|||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
1441699|NCT00923247|Secondary|Maximum Bortezomib Plasma Concentration Normalized to Dose (Cmax/D)|Geometric mean for Bortezomib pharmacokinetic (PK) parameters both before (cycle 1 day 1) and during steady-state Vandetanib (cycle 3 day 1; exposures are dose normalized). Bortezomib plasma concentrations were measured using a validated LC-MS/MS assay with a lower limit of quantification (LLOQ) of 1 ng/mL. Only measured concentrations above the LLOQ were used in the calculation of PK parameters. The maximum plasma concentration (Cmax) was recorded as observed values.|Cycle 1 day 1, and cycle 3 day 1 (an average of 61 days); and Pre-dose, 1, 2,4, 6, 8, 10 and 24 hours post dose|“7/14 patients were analyzed on day 1; 13/14 patients analyzed on day 61. Those patients that were not analyzed had insufficient PK data to calculate this parameter.”|||ng/mL/mg||95% Confidence Interval|Geometric Mean
1441700|NCT00923247|Secondary|Percentage of Participants With a Change in Consistency in Tumor-Related Diarrhea Compared to Baseline|Baseline stool consistency (formed, loose or partially formed, watery) will be the consistency most frequently observed during a 7-day period immediately prior to starting vandetanib. Complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.|Baseline, and for a period of at least 4 weeks post study drug administration|This outcome measure was not analyzed because the number of patients eligible for this response is 0, in both the Phase I and Phase II cohorts. None of the participants met the criteria of >=5 watery stools per day at baseline. No participants were enrolled in the phase IIB cohort.||||||
1441777|NCT00922701|Primary|Long Dwell Ultrafiltration|The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.|day 5||||milliliters||Standard Deviation|Mean
1441701|NCT00923247|Secondary|Percentage of Participants With a Change in Frequency in Tumor-Related Diarrhea Compared to Baseline|Complete response is an average of 0-2 formed stools per day for a period of at least 4 weeks. partial response is a ≥50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks. No response is criteria for CR or PR not met. Only patients with a stool frequency of ≥5/day and a stool consistency of watery will be evaluable for clinical response.|Baseline, and for a period of at least 4 weeks post study drug administration|This outcome measure was not analyzed because no participant had a baseline diarrhea that met the criteria for analysis. They needed to have diarrhea 5 times a day for several days in a row and no one had the baseline problem.||||||
1441702|NCT00923247|Secondary|Number of Participants With Tumor Biomarker Carcinoembryonic Antigen (CEA) Response|Carcinoembryonic Antigen (CEA) was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CEA level following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CEA level relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CEA relative to the baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Stable disease is <50% increase or decrease in CEA level relative to the baseline level.|4 weeks|No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CEA levels that are >2 times the upper limit of normal are evaluable for biomarker response. There were 14 participants that met this criteria.|||Participants|||Count of Participants
1441703|NCT00923247|Secondary|Number of Participants With Tumor Biomarker Calcitonin (CTN) Response|Calcitonin was measured by the biomarker response criteria. Complete response (CR) is normalization (≤ upper limit of normal) of CTN level following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a ≥50% decrease in the CTN level relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Progressive disease is a ≥50% increase in the CTN relative to the baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Stable disease is <50% increase or decrease in CTN level relative to the baseline level.|4 weeks|No participants were enrolled in the phase IIB cohort. Only participants with average pre-treatment CTN levels that are >2 times the upper limit of normal are evaluable for biomarker response. There were 16 participants that met this criteria.|||Participants|||Count of Participants
1441704|NCT00923247|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0. For the detailed list of adverse events see the adverse event module.|Date treatment consent signed to date off study, approximately 7 years and 9 days|No participants were enrolled in the phase IIB cohort.|||Participants|||Count of Participants
1441705|NCT00923247|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the duration of time from start of treatment to time of progression. Comparison of PFS between cohorts 1, 2A and 2B was to be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2-3 years|A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.|||Months||Full Range|Median
1441706|NCT00923247|Secondary|Response Rate (Complete Response (CR) + Partial Response (PR) of Adults With a Diagnosis of MTC Treated With Either of Two Regimens: (1) Daily Oral Vandetanib and Bortezomib or (2) Daily Oral Vandetanib|Comparison of response between cohorts 1, 2A and 2B was to be determined by computed tomography scan reviews using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|2-3 years|A comparison between phase 1, 2A and 2B was not done because no participants were enrolled in the phase 2B cohort.|||Participants|||Count of Participants
1441707|NCT00923247|Primary|Phase 2: Progression Free Survival in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib|"Progression free survival is defined as the duration of time from start of treatment to time of progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator)."|4 months|No participants were enrolled in the phase IIB cohort. One participant was in cohort 2A, thus standard deviation could not be calculated.|||months||Standard Deviation|Median
1441708|NCT00923247|Primary|Phase 2: Tumor Response in Adults With a Diagnosis of Medullary Thyroid Cancer (MTC) Treated With Daily Oral Vandetanib and Bortezomib|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|4 months|No participants were enrolled in the phase IIB cohort.|||Participants|||Count of Participants
1441709|NCT00923247|Primary|Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Bortezomib|A maximum tolerated dose for bortezomib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.|80 days||||mg/m^2|||Number
1441710|NCT00923247|Primary|Phase I: Maximum Tolerated Dose (MTD) of Daily Oral Vandetanib|A maximum tolerated dose for vandetanib will be determined if dose limiting toxicity is observed in 2 or more patients at one of the dose levels being evaluated. The MTD will be the dose level immediately preceding the dose level at which DLT (e.g. defined as neutrophil count below 1000/ µL (grade 3) on 2 consecutive measurements drawn at least 72 hours OR a single neutrophil count below 500/µL occurred. Platelet count below 50,000 µL (grade 3) on 2 consecutive measurements drawn at least 72 hours apart OR a singe platelet count below 25,000/µL. A platelet transfusion administered when platelet count is below 50,000/µL is dose limiting thrombocytopenia, unless the transfusion is being administered for peri-operative coverage.|80 days||||mg|||Number
1441711|NCT00923195|Secondary|Toxicity Profile|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|32 months||||Participants|||Number
1441712|NCT00923195|Primary|Complete Response Rates for Patients With Metastatic Melanoma|Complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is a disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|Every 4-6 weeks after initial treatment regimen. If the patient has stable disease or tumor shrinkage, complete evaluations will be repeated every 1-3 months.||||Participants|||Number
1441713|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Terminal Elimination Half-life (T½)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hour||Standard Deviation|Mean
1441714|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
1441715|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
1441716|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau)|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
1441717|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||ng/mL||Standard Deviation|Mean
1441718|NCT00923156|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration|Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose.|12 weeks|All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis.|||Hour||Full Range|Median
1441719|NCT00923156|Secondary|Biomarker Urinary Aldosterone After 12 Weeks of Treatment|24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose.|Baseline,12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.|||ratio||95% Confidence Interval|Geometric Mean
1441720|NCT00923156|Secondary|Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose.|Baseline, 12 weeks (Day 84 period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.|||ratio||95% Confidence Interval|Geometric Mean
1441721|NCT00923156|Secondary|Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose.|Baseline,12 weeks (84 days, Period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."|||ratio||95% Confidence Interval|Geometric Mean
1442153|NCT00919191|Secondary|Self Assessment of Burning/Stinging and Itching|Cumulative scores of Subjects' self assessment of burning/stinging and itching on a score from 0=none to 3=severe|Daily, for 3 weeks||||Scores on a Scale||Standard Deviation|Mean
1441722|NCT00923156|Secondary|Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose.|Baseline, 12 weeks (84 days, period 2)|Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included.|||ratio||95% Confidence Interval|Geometric Mean
1441723|NCT00923156|Primary|Venous Angiotensin II Levels After 12 Weeks of Treatment|Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose.|Baseline. 12 Weeks (Day 84, period 2)|"Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point."|||ratio||95% Confidence Interval|Geometric Mean
1441724|NCT00923130|Other Pre-specified|Regression Rate Constant (d)|This assessment was intended as an exploratory analysis.|up to 50 days|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441725|NCT00923130|Other Pre-specified|Percentage of Participants With an Increase or Decrease in Reverse Contrast Transfer Rate (Kep) Using MRI Versus Conventional Imaging|This assessment was intended as an exploratory analysis.|Cycle 1 before day 1 of treatment and day 5 following infusion|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441726|NCT00923130|Other Pre-specified|Percentage of Participants With an Increase or Decrease in Forward Contrast Transfer Rate (Ktrans) Using MRI Versus Conventional Imaging|This assessment was intended as an exploratory analysis.|Cycle 1 before day 1 of treatment and day 5 following infusion|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441727|NCT00923130|Other Pre-specified|Growth Rate Constant (g)|This assessment was intended as an exploratory analysis.|up to 50 days|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441728|NCT00923130|Other Pre-specified|Tumor Endothelial Markers (TEMs)|This assessment was intended as an exploratory analysis.|Cycle 1 Day 5, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 6 Day 1|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441729|NCT00923130|Other Pre-specified|Micro Vessel Density|This assessment was intended as an exploratory analysis|Prior to cycle 2|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441730|NCT00923130|Other Pre-specified|Circulating Endothelial Cells (CECs)|This assessment was intended as an exploratory analysis.|Baseline, Day 5, and Cycle 2 Day 1|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441731|NCT00923130|Other Pre-specified|Protein Profiling of Vascular Endothelial Growth Factor A (VEGF-A), Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2), Vascular Endothelial Growth Factor Receptor 3 (VEGFR-3), Beta Fibroblast Growth Factor (βFGF) and Erythropoietin From Baseline|This assessment was intended as an exploratory analysis.|Cycle 1 Day 5 (C1D5), Cycle 2 Day 1 (C2D1), Cycle 4 and Cycle 6|This outcome measure was not done. Data was not collected because the clinical data did not support further analysis and interest.||||||
1441732|NCT00923130|Secondary|Overall Survival|Time between the first day of treatment and the day of death.|Time between the first day of treatment and the day of death, assessed up to approximately 7 years.||||months||95% Confidence Interval|Median
1441733|NCT00923130|Secondary|Number of Participants Who Had Biopsies|To obtain tumor tissue and perform analysis for molecular changes in the tumor before and after a cycle of chemotherapy.|Baseline and Cycle 2 Day 1|This outcome measure was not done because biopsy samples were not obtained.||||||
1441734|NCT00923130|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. Adverse events are assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Date treatment consent signed to date off study, approximately 84 months and 25 days||||Participants|||Count of Participants
1441735|NCT00923130|Secondary|Number of Participants With an Objective Response (Complete Response (CR) or Partial Response (PR)) Per the Response Evaluation Criteria in Solid Tumors (RECIST)|Response (complete response (CR) and partial response (PR)) was measured by the RECIST. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Two Years||||Participants|||Count of Participants
1441736|NCT00923130|Primary|Progression-free Survival|The time between the first day of treatment to the day of disease progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to 44 months||||months||95% Confidence Interval|Median
1441737|NCT00923117|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7/2/08 -12/6/13||||Participants|||Number
1441738|NCT00923117|Primary|6-month Progression-free Survival.|Time between the start of treatment to progression. Progression is defined by the RANO(Response Assessment in Neuro-Oncology) criteria. Progression is defined by any of the following: 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.|6 months|63 patients enrolled with glioblastoma multiforme (GBM) (32 Bev naive, 31 Bev resistant) and were evaluated for this outcome measure.|||Months||95% Confidence Interval|Median
1441739|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25.||Week 26 to week 54|The number of subjects up titrated who had blood pressure values at both time points.|||mm Hg||Standard Deviation|Mean
1441740|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 26|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V|||Participants|||Number
1441741|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.|||mm Hg||Standard Error|Least Squares Mean
1441742|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 22 to Week 26||Week 22 to week 26|The Full Analysis Set 3=312 randomized participants who received at least one dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period V.|||mm Hg||Standard Error|Least Squares Mean
1441743|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV|||Participants|||Number
1441744|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one blood pressure measurement in Period IV|||mm Hg||Standard Error|Least Squares Mean
1441745|NCT00923091|Secondary|Change in Seated Diastolic Blood Pressure From Week 18 to Week 22||Week 18 to week 22|The Full Analysis Set 2=681 randomized participants who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period IV|||mm Hg||Standard Error|Least Squares Mean
1441746|NCT00923091|Secondary|Number of Subjects Reaching Blood Pressure Goal at Week 10|Blood pressure treatment goal was defined as blood pressure <140/90 mmHg or <130/80 mmHg for subjects with diabetes, chronic renal disease, or chronic cardiovascular disease.|baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II|||Participants|||Number
1441747|NCT00923091|Secondary|Change in Seated Systolic Blood Pressure (SeDBP).||Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II|||mm Hg||Standard Error|Least Squares Mean
1441748|NCT00923091|Primary|Change in Seated Diastolic Blood Pressure (SeDBP).|Baseline blood pressure was defined as the average values obtained at the randomization visit and at the visit prior to randomization|Baseline to week 10|The full analysis set includes 2679 randomized patients who received at least 1 dose of double-blind medication and who provided at least one diastolic blood pressure measurement in Period I-II|||mm HG||Standard Error|Least Squares Mean
1441749|NCT00923078|Secondary|Auditory Working Memory (LNS) Change|Auditory working memory is assessed in the MCCB using the Letter-Number Sequencing (LNS) task. LNS is an orally administered test in which and examiner reads strings of numbers and letters, of increasing length over trials, and the respondent mentally reorders the string and reports back to the examiner verbally. Scores represent total number of accurate trials. Analysis is based on age- and gender-corrected t-scores. LNS reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
1441750|NCT00923078|Secondary|Visual Working Memory (Spatial Span) Change|Visual working memory is assessed in the MCCB using the Spatial Span task of the Wechsler Memory Scales-III. Using a board on which 10 cubes are irregularly spaced, the examiner taps patterns of increasing length. The respondent is asked to follow by tapping the pattern in the same or reverse sequence. Scores represent total accuracy combined over forward and reverse span conditions. Analysis is based on age- and gender-corrected t-scores. Spatial Span reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
1441751|NCT00923078|Secondary|Verbal Learning (HVLT-R) Change|The verbal learning domain of the MCCB is assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R). In three Learning Trials, the respondent listens to a 12-item word list read by an examiner and is then asked to recall as many of the words as possible from memory. Scores represent overall accuracy across the three trials, with higher scores indicating better learning. Analysis is based on age- and gender-corrected t-scores. HVLT-R reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
1441752|NCT00923078|Secondary|Visual Learning (BVMT-R) Change|The visual learning domain of the MCCB is assessed using the Brief Visuospatial Memory Test-Revised (BVMT-R). In three Learning Trials, the respondent views a stimulus display for 10 seconds and is then asked to draw as many of the figures as possible in their correct location on a page in the response booklet. Scores represent overall accuracy across the three trials, with higher scores indicating better learning. Analysis is based on age- and gender-corrected t-scores. BVMT-R reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||t-score||Standard Error|Mean
1441763|NCT00922987|Secondary|Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit|The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant’s final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.|Baseline and week 16 or ET|MFAS included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis. Analysis was done using last observation carried forward (LOCF) method.|||percent change||95% Confidence Interval|Median
1441753|NCT00923078|Primary|MCCB Cognitive Composite Score Change|The Cognitive Composite score is derived from the MATRICS Consensus Cognitive Battery (MCCB). The MCCB consists of 10 tests and provides standard scores for each according to seven cognitive domains: (1) speed of processing, (2) attention/vigilance, (3) working memory (verbal and visual), (4) verbal learning, (5) visual learning, (6) reasoning and problem solving, and (7) social cognition. The primary dependent measures derived from the MCCB for purpose of this study is the cognitive composite score, computed as the average of standard (t-scores) scores from each domain excluding social cognition. MCCB Composite reported as difference scores from baseline with negative values indicating higher test performance.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks|Of N=40 randomized, analysis was based on 38 who completed intervention and post-testing. Across conditions, participants completed, on average, 14.61 hrs of training in Period 1 (12.53 visual, 16.70 auditory) and 14.41 hrs in Period 2 (13.00 visual, 15.92 auditory)|||t-score||Standard Error|Mean
1441754|NCT00923078|Primary|Auditory Mismatch Negativity (MMN) Amplitude Change|Auditory MMN is a fronto-central, mid-latency, potential generated by the auditory cortex in response to deviation in a repetitive stimulus sequence. MMN was assessed using a 3-deviant paradigm in which a series of standard tones (633 Hz, 50ms duration,90%) is interrupted by deviants (10%) that differ either by (1) pitch (1000Hz, 50ms), (2) duration (633 Hz, 100ms), or (3) both (1000Hz, 100ms). MMN was tested concurrently with Visual P300 using a combined task in which subjects were instructed to ignore the auditory stimuli and focus on the visual stimuli. MMN is scored by subtracting each deviant ERP waveform from the standard waveform and measuring the most negative deflection in a window of 50 to 265ms post-stimulus from the resulting difference wave. Primary analysis is based on the combined deviant condition scored at the frontal midline (Fz) electrode site. MMN reported as difference scores from baseline with positive values indicating increased MMN.|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||microvolts (uV)||Standard Error|Mean
1441755|NCT00923078|Primary|Visual Target Detection (P300 Event-related Potential Amplitude) Change|"Visual P300 was measured in a 3-stimulus target detection task with target stimuli (10%; large circle) presented in pseudo random order amidst a series of novel (10%; fractal), and standard (80%; small circle) images on a 24 LCD monitor at 100cm viewing distance. Subjects are instructed to press a reaction time button with the preferred hand to Targets only, giving equal importance to speed and accuracy. Primary analysis are based on Target P300b identified as the most positive amplitude deflection within the window of 250-550ms post stimulus at posterior midline electrode Pz. The P300b component is thought to reflect cognitive processes involved in memory updating and decision making. P300 reported as difference scores from baseline with negative values indicating increased P300."|Baseline; Post 4 weeks (treatment crossover); Post 8 weeks||||microvolts (uV)||Standard Error|Mean
1441756|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Co-morbidities|Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.|Baseline through week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.|||participants|||Number
1441757|NCT00922987|Other Pre-specified|Number of Participants With Concomitant Drug Treatments|Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.|Baseline through Week 16 or ET|Safety analysis set included all enrolled participants who received 1 dose of study medication.|||participants|||Number
1441758|NCT00922987|Secondary|Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET|MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.|Baseline and week 16 or ET|The FAS included all participants who received at least 1 dose of the study drug and had at least one efficacy measurement.|||Units on a scale||Standard Deviation|Mean
1441759|NCT00922987|Secondary|Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit|"The CGI-C scale measures a physician’s global impression of a participant’s clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).~At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse."|Week 16 or ET|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.|||Participants|||Number
1441760|NCT00922987|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline|FAS: Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing.|||participants|||Number
1441761|NCT00922987|Secondary|Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit|VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).|Baseline, week 4 and week 16 or ET|Full Analysis Set (FAS): Included all participants who received at least 1 dose of study drug. Participants who did not have the minimum required data for the statistical summary were treated as missing. Analysis was done using LOCF method.|||millimeter (mm)||95% Confidence Interval|Mean
1441762|NCT00922987|Secondary|Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study|Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.|Week 4 through week 16 or ET|MFAS: Data collected during the titration phase, i.e. prior to Visit 2 (Week 4) were not analyzed for this endpoint. Only participants who did not discontinue in the first 4 weeks after the baseline visit (titration phase) and had at least 4 weeks of seizure data during the maintenance phase were analyzed for this endpoint.|||Participants|||Number
1441764|NCT00922987|Primary|Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency|Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 – Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.|Baseline through week 16 or early termination (ET)|The modified full analysis set (MFAS) included all participants who received at least 1 dose of the study drug and who had at least one baseline seizure. Participants who discontinued during first 4 weeks titration phase were regarded as missing and were excluded from the analysis.|||Percentage of participants||95% Confidence Interval|Number
1441765|NCT00922935|Primary|Bone Level Change on Radiographs|Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.|3 years after loading||||mm||Standard Deviation|Mean
1441766|NCT00922883|Primary|The Portion of Drug Responders as Defined by Hematologic Improvements|Defined as unilineage or multilineage recovery by 1 or more of the following: 1) platelet response (increase to 20 × 103/μL above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks in those who were transfusion dependent on entry into the protocol); (2) erythroid response (when pretreatment hemoglobin was <9 g/dL, defined as an increase in hemoglobin by 1.5 g/dL or, in transfused patients, a reduction in the units of packed red blood cell transfusions by an absolute number of at least 4 transfusions for 8 consecutive weeks, compared with the pretreatment transfusion number in the previous 8 weeks); and (3) neutrophil response (when pretreatment absolute neutrophil count [ANC] of <0.5 × 103/μL as at least a 100% increase in ANC, or an ANC increase >0.5 × 103/μL, and the toxicity profile as measured using Common Terminology Criteria for Adverse Events).|12-16 weeks|All subjects who received Eltrombopag were analyzed.|||Participants|||Count of Participants
1441767|NCT00922779|Secondary|Percentage of Participants With Change in Hemoglobin Level|Change in hemoglobin level (compared to baseline) was reported as “significant decrease”, “Normal” (no change), “Increase”, “Decrease”, and “Missing”. Significant decrease was defined as per Investigator's discretion.|Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)|ITT Population.|||Percentage of Participants|||Number
1441768|NCT00922779|Secondary|Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation|HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48.|Weeks 12,24 and 48 After Therapy Initiation|ITT Population.|||Percentage of Participants|||Number
1441769|NCT00922779|Secondary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy|SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.|24 weeks after end of therapy (Week 72)|Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin.|||Percentage of Participants|||Number
1441770|NCT00922779|Primary|Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.|From signing of informed consent up to end of study (up to Week 72)|Safety analysis population included all participants who received at least one therapeutic dose of ribavirin.|||Participants|||Number
1441771|NCT00922766|Other Pre-specified|Number of Participants With Heparin Induced Thrombocytopenia|Thrombocytopenia was defined as a disorder in which there is an abnormally low platelet count. A normal platelet count ranged from 150,000 to 450,000 platelets per micro liter of blood.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
1441772|NCT00922766|Other Pre-specified|Number of Participants With Cardiac Arrest- Resuscitated|Cardiac arrest resuscitated was defined as sudden cessation of cardiac activity so that the participant became unresponsive, with no normal breathing and no signs of circulation. Cardiac arrest was used to signify an event that was reversed, usually by cardio-pulmonary resuscitation (CPR) and/or defibrillation or cardioversion, or cardiac pacing.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
1441773|NCT00922766|Other Pre-specified|Number of Participants With Stroke|Stroke was defined as a sudden, focal neurologic deficit that was not reversible within 24 hours and was not the result of any readily identifiable cause (for example, tumor or trauma).|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
1441774|NCT00922766|Primary|Number of Participants With Minor Bleeding Events|Bleeding events like hematuria, wound hematoma or injection site hematoma which did not fulfill the criteria for a major bleeding episode were classified as minor bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
1441775|NCT00922766|Primary|Number of Participants With Major Bleeding Events|Bleeding events were considered major if, accompanied by a decrease in hemoglobin of more than or equal to 2 grams/deciliter (g/dL) in connection with clinical symptoms; a transfusion was required; bleeding led to interruption of treatment or death; or intracranial bleeding.|Baseline to 28 days after last dose of study drug|FAS included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
1441776|NCT00922766|Primary|Number of Participants With Death or Myocardial Infarction (MI)||Baseline to 28 days after last dose of study drug|The full analysis set (FAS) included all enrolled participants who received at least 1 dose of the study medication.|||Participants|||Number
1441778|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||Participants|||Number
1441779|NCT00922636|Secondary|Number of Participants With a Response (Response Rate) up to Week 8|Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score <=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.|Baseline, up to 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||Participants|||Number
1441780|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441781|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8|Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441782|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 in Stimulant Naive Methylphenidate Group|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441783|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8|A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441784|NCT00922636|Secondary|Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441837|NCT00922428|Primary|Tenderness|Number of patients (in%) with an improvement of tenderness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
1441785|NCT00922636|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8|Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441786|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.||||||
1441787|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8|The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.|Baseline, 8 weeks|No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.||||||
1441788|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441789|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8|Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline evening score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441790|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441791|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8|Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline morning score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441792|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441838|NCT00922428|Primary|Morning Stiffness|Number of patients (in%) with an improvement of morning stiffness between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
1441793|NCT00922636|Secondary|Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8|Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441794|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441795|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8|Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441796|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441797|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8|Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441798|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 in Stimulant Naive Methylphenidate Group|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441799|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8|Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441843|NCT00922428|Secondary|Acceptance of the Drug|Number of patients with good (patient was satisfied with the treatment, there was nothing to complain about) or poor (patient was not satisfied with the treatment, there were ADRs or other reasons) acceptance.|from enrollment until completion|due to the character of an observational study: descriptive|||percentage of participants|||Number
1441800|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441801|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8|Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441802|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441803|NCT00922636|Secondary|Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8|Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441804|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. LS Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441805|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 in Stimulant Naive Methylphenidate Group|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441839|NCT00922428|Primary|Pain on Weight-bearing|Number of patients (in%) with an improvement of pain on weight-bearing between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
1441887|NCT00922207|Secondary|Percentage of Participants Who Were HBeAg Negative||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants||95% Confidence Interval|Number
1441806|NCT00922636|Secondary|Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8|Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441807|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group|76-item parent-rated assessment of child’s health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of ANCOVA model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441808|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8|76-item parent-rated assessment of child’s health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of covariance model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441809|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group|Assesses adolescent’s health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least squares (LS) mean of the change from baseline to endpoint (week 8) is from an ANCOVA model. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline CHIP-AE domain score.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441810|NCT00922636|Secondary|Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8|Assesses adolescent’s health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least Squares (LS) Mean Change from analysis of covariance model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline score.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441811|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441812|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8|Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score, baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441840|NCT00922428|Primary|Pain After Rest|Number of patients (in %) with an improvement of pain after rest between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
1441813|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at 8 Weeks in Stimulant Naive Methylphenidate Group|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441814|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at Week 8|Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441815|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 in Stimulant Naive Methylphenidate Group|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||Participants|||Number
1441816|NCT00922636|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8|"Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide."|8 weeks|Intent to treat (ITT). All randomized participants with a baseline and at least 1 post-baseline C-SSRS assessment.|||Participants|||Number
1441817|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441818|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8|Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441819|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441841|NCT00922428|Primary|Pain in Movement|Number of patients (in %) with an improvement of pain in movement between V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
1441820|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8|Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441821|NCT00922636|Secondary|Change From Baseline in the CP-CBRS DSM-IV-TR ADHD Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 in Stimulant Naive Methylphenidate Group|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441822|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8|Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441823|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) in Stimulant Naive Methylphenidate Group|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||Total Score||Standard Error|Least Squares Mean
1441824|NCT00922636|Secondary|Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8)|Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction.|Weeks 1 through 8|Per protocol (PP) population included all randomized participants with a post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441825|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441826|NCT00922636|Secondary|Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8|Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441842|NCT00922428|Primary|Pain at Rest|Number of patient (in %) with an improvement of pain at rest between V1 and V2 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
1442193|NCT00918866|Secondary|Immunology Panel- Interleuken-6|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||pg/ml||Standard Deviation|Mean
1441827|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 in Stimulant Naive Methylphenidate Group|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441828|NCT00922636|Secondary|Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8|The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline total score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||T-Score||Standard Error|Least Squares Mean
1441829|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441830|NCT00922636|Secondary|Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8|Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and the continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) participant population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441831|NCT00922636|Primary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8|Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment*visit interaction, and continuous, fixed effects of baseline score and baseline score*visit interaction.|Baseline, 8 weeks|Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data might have been compromised.|||units on a scale||Standard Error|Least Squares Mean
1441832|NCT00922623|Primary|Percentage of Subjects With Product-related Adverse Events.|Adverse events considered possibly, probably, or definitely related to study product are summarized by body system and MedDRA preferred term.|24 weeks|The Full Analysis Set (FAS) consisted of all subjects enrolled and treated with Belotero (ITT principle).|||percentage of subjects with AEs.|||Number
1441833|NCT00922480|Secondary|Diastolic Blood Pressure Change|"Value of DBP at 4 Weeks minus value of DBP at Baseline while in a sitting position~Value of DBP at 8 Weeks minus value of DBP at Baseline while in a sitting position"|baseline and 4 weeks, 8 weeks|As ITT group, these are subjects who have been randomly assigned and have at least one primary end point.|||mmHg||Standard Deviation|Mean
1441834|NCT00922480|Primary|Diastolic Blood Pressure Change|Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position|baseline and 12 weeks|As ITT group, these are subjects who have been randomly assigned and have at least one primary end point.|||mmHg||Standard Deviation|Mean
1441835|NCT00922441|Primary|Mean Change of Diastolic Blood Pressure|24hr Mean change of DBP on Week 8, from Baseline|baseline and 8 Weeks||||mmHg||Standard Deviation|Mean
1441836|NCT00922428|Primary|Antalgic Position|Number of patients (in%) with an improvement of antalgic position V1 and V3 / V1 and V3 / V2 and V3 A four-point scale (0=not present, 1=slightly, 2=moderate, 3=severe) was used to record symptom severity before the beginning, during treatment and at the end of the observation period.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: descriptive, all patients who had an value|||percentage of participants|||Number
1442194|NCT00918866|Secondary|Immunology Panel- Complement 5A(C5A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||ng/ml||Standard Deviation|Mean
1441844|NCT00922428|Primary|Tolerability of the Drug|"Tolerability assessment of medical personnel End of study could by after 2 (visit 2) or after 4 weeks (Visit3).~It was measured by a score:~very well tolerated (no side effects)~moderately tolerated (mild side effects)~poorly tolerated (marked side effects)"|after end of study|1374 were full analysed, data of 2 patient were additionally analysed for tolerability|||percentage of participants|||Number
1441845|NCT00922428|Primary|Visual Analog Scale (VAS)|Efficacy of the drug, measured by a Visual Analog Scale (VAS) Scale ranged from 0(=best, no pain) to 10(worst, intolerable pain) The VAS was filled by the patient.|Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3)|due to character of an observational study: all patient who had a value, descriptive|||units on a scale||Standard Deviation|Mean
1441846|NCT00922272|Secondary|Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 4 of Double-blind Phase|Randomized SAS defined as all subjects who took at least 1 dose of randomized investigational product and for whom at least 1 follow-up safety assessment was made.|||Units on a scale||Standard Deviation|Mean
1441847|NCT00922272|Secondary|Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Open-label Baseline and Week 10 Open-label Phase|Safety Analysis Set (SAS) defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.|||Units on a scale||Standard Deviation|Mean
1441848|NCT00922272|Secondary|Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
1441849|NCT00922272|Secondary|Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase|PSQI evaluates 7 areas of quality and pattern of sleep. Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.|Open-label Baseline and Week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
1441850|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
1441851|NCT00922272|Secondary|Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Open-label Baseline and Week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
1441852|NCT00922272|Secondary|Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
1441853|NCT00922272|Secondary|Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Open-label Baseline and week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
1441854|NCT00922272|Secondary|Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 4 Double-blind Phase|Randomized SAS|||Units on a scale||Standard Deviation|Mean
1441855|NCT00922272|Secondary|Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Open-label Baseline and Week 10 Open-label Phase|SAS|||Units on a scale||Standard Deviation|Mean
1441856|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS|||T-scores||Standard Error|Least Squares Mean
1441857|NCT00922272|Secondary|Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase|BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS|||T-scores||Standard Deviation|Mean
1441858|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
1441859|NCT00922272|Secondary|Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF|UPSA-B assesses skills in 5 areas of life functioning. It contains 2 subscales. Percentages correct on these 2 subscales are multiplied by 50. Thus, scores can range from 0 to 50 on each of these 2 subscales, and total scores can range from 0 to 100. Scores of 75 or higher are associated with independent living.|Open-label Baseline and week 10 Open-label Phase|FAS|||Scores on a scale||Standard Deviation|Mean
1441860|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Double-blind Randomization Baseline and week 4 Double-blind Phase|Randomized FAS|||words recalled||Standard Error|Least Squares Mean
1441861|NCT00922272|Secondary|Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase|HVLT-R measures verbal learning. Test scores are the total number of words recalled correctly over 3 trials. The test consists of 12 nouns read aloud for 3 consecutive trials and each trial is followed by a recall test.|Open-label Baseline and Week 10|FAS|||words recalled||Standard Deviation|Mean
1441862|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Double-blind Randomization Baseline and Week 4|Randomized FAS|||correct sequences||Standard Error|Least Squares Mean
1441863|NCT00922272|Secondary|Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase|LNS is a test of verbal working memory. Subjects are presented with a sequence of numbers and letters aurally and then asked to tell the rater the numbers first from lowest to highest followed by the letters in alphabetical sequence. The measure is the number of correct sequences.|Open-label Baseline and week 10 Open-label Phase|FAS|||correct sequences||Standard Deviation|Mean
1441864|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Double-blind Randomization Baseline and Week 4|Randomized FAS|||correct numerals||Standard Error|Least Squares Mean
1441865|NCT00922272|Secondary|Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase|BACS measures attention and speed of processing, and the test score is the total number correct. The measure of the test is the number of correct numerals where subjects write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 seconds, based upon a key provided to them.|Open-label Baseline and week 10 Open-label Phase|FAS|||correct numerals||Standard Deviation|Mean
1441866|NCT00922272|Secondary|Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Double-blind Phase Week 4|Randomized FAS|||Percent of participants|||Number
1441867|NCT00922272|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase|CGI-C permits a global evaluation of the change of the subject's overall schizophrenia condition over time. It consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Open-label Phase Week 10|FAS|||Percent of participants|||Number
1441868|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 4 Double-blind Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 4 Double-blind Phase|Randomized FAS|||Percent of participants|||Number
1441869|NCT00922272|Secondary|Percent of Participants With CGI-S at Double-blind Randomization Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Double-blind Randomization Baseline|Randomized FAS|||Percent of participants|||Number
1441870|NCT00922272|Secondary|Percent of Participants With CGI-S at Week 10 Open-label Phase|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Week 10 Open-label Phase|FAS|||Percent of participants|||Number
1441871|NCT00922272|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Open-label Baseline|FAS|||Percent of participants|||Number
1441872|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized FAS defined as all subjects who received randomized investigational product and had a SANS-18 total scores at week 4 or at the early termination visit.|||Units on a scale||Standard Error|Least Squares Mean
1442195|NCT00918866|Secondary|Immunology Panel- Complement 3A (C3A)|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||ng/ml||Standard Deviation|Mean
1441873|NCT00922272|Secondary|Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS|||Units on a scale||Standard Deviation|Mean
1441874|NCT00922272|Secondary|Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|RES|||Units on a scale||Standard Error|Least Squares Mean
1441875|NCT00922272|Secondary|Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase|The SANS assesses 5 symptom complexes to rate the negative symptoms of subjects. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|FAS|||Units on a scale||Standard Deviation|Mean
1441876|NCT00922272|Secondary|Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.~The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 4 Double-blind Phase|RES|||Percent of participants|||Number
1441877|NCT00922272|Primary|Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Double-blind Randomization Baseline and Week 4 Double-blind Phase|Randomized Evaluable Set (RES) defined as all randomized subjects who were responders (Response is defined as reduction in total SANS score of greater than or equal to 20%) at the Double-blind Randomization and had SANS-18 total scores at week 4 of the Double-blind Phase or the early termination visit.|||Units on a scale||Standard Error|Least Squares Mean
1441878|NCT00922272|Secondary|Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase|"Response is defined as reduction in total SANS score of greater than or equal to 20%.~The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment."|Week 10 Open-label Phase|FAS|||Percent of participants|||Number
1441879|NCT00922272|Primary|Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Open-label Baseline and Week 10 Open-label Phase|Open-label Phase Full Analysis Set (FAS) defined as all enrolled subjects who took at least 1 dose of the investigational product and had 1 primary efficacy assessment after baseline in the Open-label Phase.|||Units on a scale||Standard Deviation|Mean
1441880|NCT00922233|Primary|Participant Report of Adverse Events.|Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken|6.5 months|A total of 58 women documented use of product on coital diaries and are included in the User Population for primary safety analysis. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.|||adverse events|||Number
1441881|NCT00922233|Secondary|Acceptability Based on Bleeding Patterns Reported|Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel|6.5 months|A total of 56 women reported on their bleeding patterns, of these, 43 found it acceptable. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.|||participants|||Number
1441882|NCT00922233|Primary|Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)|Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived|6.5 months||||pregnancies per 100 woman years|||Number
1441883|NCT00922207|Secondary|Percentage of Participants With Combined Response|Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants|||Number
1441884|NCT00922207|Secondary|Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||International Units/milliliter (IU/mL)||Standard Deviation|Mean
1441885|NCT00922207|Secondary|Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels|The normal range for ALT is 10 to 40 international units per liter (IU/L).|Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants|||Number
1441886|NCT00922207|Secondary|Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive||Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||percentage of participants|||Number
1441888|NCT00922207|Secondary|Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100|ITT analysis population. Here, n = participants who had available assessment at specified time-point.|||copies/mL||Standard Deviation|Mean
1441889|NCT00922207|Primary|Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment|HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).|Week 100|ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1441890|NCT00922194|Primary|Change in Glycosylated Haemoglobin (A1C) From Baseline at 12 Months or More|Change: Glycosylated Haemoglobin after 12 months or more of therapy - Glycosylated Haemoglobin at baseline.|Initial and at the end of 12 months or more||||Percentage of HbA1c||95% Confidence Interval|Median
1441891|NCT00922194|Primary|Change in Fasting Blood Glucose From Baseline at 12 Months or More|Change: Fasting blood glucose after 12 months or more of therapy - Fasting blood glucose at baseline|Initial and at the end of 12 months or more||||mmol/L||95% Confidence Interval|Median
1441892|NCT00922194|Primary|Change in Waist (Cms) /Height (Meters) Ratio From Baseline at 12 Months or More|Change: Waist/Height ratio after 12 months or more of therapy - Waist/Height ratio at baseline|Initial and at the end of 12 months or more||||Ratio||95% Confidence Interval|Median
1441893|NCT00922194|Primary|Change in Waist Circumference (Cms)/Hip Circumference (Cms)From Baseline at 12 Months or More|Change: Waist circumference/Hip circumference ratio after 12 months or more of therapy - Waist circumference/Hip circumference ratio at baseline|Initial and at the end of 12 months or more||||Ratio||95% Confidence Interval|Median
1441894|NCT00922194|Primary|Change in Waist Circumference From Baseline at 12 Months or More|Change: Waist circumference after 12 months or more of therapy - Waist circumference at baseline|Initial and at the end of 12 months or more||||Centimeters||95% Confidence Interval|Median
1441895|NCT00922194|Primary|Change in Body Mass Index (BMI) From Baseline at 12 Months or More|Change: Body Mass Index (BMI) after 12 months of therapy or more - BMI at baseline|Initial and at the end of 12 months or more||||kg/m2||95% Confidence Interval|Median
1441896|NCT00922194|Primary|Change in Weight From Baseline at 12 Months or More|Change: Weight after 12 months of therapy or more - weight at baseline|Initial and at the end of 12 months or more||||Kg||95% Confidence Interval|Median
1441897|NCT00922116|Secondary|Average Dose of Mircera Per Month||Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.|||microgram (mcg)||Standard Deviation|Mean
1441898|NCT00922116|Secondary|Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.|||days||Standard Deviation|Mean
1441899|NCT00922116|Secondary|Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP|DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.|Weeks 1 to 24|ITT population.|||percentage of participants|||Number
1441900|NCT00922116|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP|EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1441901|NCT00922116|Secondary|Change in Hemoglobin Concentration Between SVP and the EEP|Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.|SVP (Baseline), and EEP (Weeks 17 to 24)|ITT population.|||grams per deciliter (g/dL)||Standard Deviation|Mean
1441902|NCT00922116|Primary|Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)|The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.|EEP (Weeks 17 to 24)|Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera.|||percentage of participants||95% Confidence Interval|Number
1441903|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)|Solicited local and general symptoms experienced within 14 days after vaccination 2|14 days after vaccination||||participants|||Number
1441904|NCT00921947|Secondary|Anti-M2e Serum Antibody Concentration|Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.|42 days (+/- 2)||||Titers||95% Confidence Interval|Geometric Mean
1441905|NCT00921947|Primary|Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)|Solicited local and general symptoms experienced within 7 days after vaccination 1.|0 to 7 days after vaccination|The population analyzed included all participants receiving at least 1 dose of the vaccine.|||participants|||Number
1441906|NCT00921934|Primary|Change of Pain Measured by VAS|VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS|visit 1 - 3|Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).|||pain intensity||Standard Deviation|Mean
1441907|NCT00921895|Primary|Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.|Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.|15 minutes||||percentage of cases||95% Confidence Interval|Number
1441908|NCT00921687|Secondary|Last Clinic BP <130/80 mmHg|Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.|One year||||probability of controlled clinic BP||95% Confidence Interval|Number
1441909|NCT00921687|Primary|PTH (Parathyroid Hormone) Adherence|Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.|One year||||probability of having a PTH measured|||Number
1441910|NCT00921557|Secondary|Percent of Participants With Detectable Urinary Alendronate|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 48, 96 and 144|||||||
1441911|NCT00921557|Secondary|Change in Centers for Disease Control (CDC) HIV Disease Category|Percentage of participants advancing in CDC HIV disease category from baseline throughout study follow-up|Weeks 144|Participants who started study treatment.|||Participants|||Count of Participants
1441912|NCT00921557|Secondary|Change in CD4 Percent From Baseline|Change in percentage of lymphocytes that are CD4 cells calculated as measurement at each time point minus baseline measurement|Weeks 0, 48, 96 and 144|Participants who started study treatment and had CD4 percent available at week 0.|||percent of lymphocytes that are CD4 cell||95% Confidence Interval|Median
1441913|NCT00921557|Secondary|Percent of Participants With HIV-1 RNA <= 400 Copies/ml|Percent calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point.|Weeks 0, 48, 96 and 144|Participants who started study treatment.|||Participants|||Count of Participants
1441914|NCT00921557|Secondary|Correlation of Changes in Central Fat Content With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
1441915|NCT00921557|Secondary|Change From Baseline to Week 48 in Central Fat Content|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
1441916|NCT00921557|Secondary|Correlation of Changes in RANKL/OPG Ratio With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
1441917|NCT00921557|Secondary|Change From Baseline to Week 48 in Receptor Activator of Nuclear Factor Kappa-B Ligand/Osteoprotegerin (RANKL/OPG) Ratio|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
1441918|NCT00921557|Secondary|Correlation of Changes in Bone Marker Turnover With Changes in Lumbar Spine and Whole Body (With Head) BMD|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
1441919|NCT00921557|Secondary|Change From Baseline to Week 48 in Bone Marker Turnover|Outcome measure required additional funding for laboratory testing which was not available, so this outcome is not reported.|Weeks 0 and 48|||||||
1441920|NCT00921557|Secondary|Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Whole Body (With Head) BMD|Percent change was calculated as (measurement at time T2 - measurement at time T2)/measurement at time T1 * 100%.|Weeks 48, 96 and 144|All participants who started study treatment and had measurements available at both time points.|||Percent change||95% Confidence Interval|Median
1441921|NCT00921557|Secondary|Percent Change From Week 48 to Week 96 (Group 1B), Week 48 to Week 144 (Group 1B), and Week 96 to 144 (Group 2) in Lumbar Spine BMD|Percent change was calculated as (measurement at time T2 - measurement at time T1)/measurement at Time T1 * 100%.|Weeks 48, 96 and 144|All participants who started study treatment and had measurements available at the two time points of interest|||Percent change||95% Confidence Interval|Median
1441922|NCT00921557|Secondary|Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Whole Body (With Head) BMD.|A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in whole body (with head) BMD from baseline. Results represent average changes in whole body (with head) BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started study treatment and had Whole Body (with head) available at week 0|||percentage of baseline||95% Confidence Interval|Mean
1441923|NCT00921557|Secondary|Effect of Other Known Bone Mineral Determinants (Age, Gender, Race/Ethnicity, Steroid Use, Depo-Provera, Tenofovir, Pubertal Stage, Bone Age, Vitamin D Status) and Inflammatory Cytokine Levels on Changes in Lumbar Spine BMD|A slope was fit for each participant to their percent change [(measurement at time T - measurement at baseline)/measurement at baseline)*100%] in lumbar spine BMD from baseline. Results represent average changes in lumbar spine BMD over one year. Results are summarized for age, gender, ethnicity, tenofovir use, Tanner stage, bone age and vitamin D level. Only one participant was on steroids and none were using Dep-Provera. Inflammatory cytokine levels were not assayed. Results were combined for Groups 1A and 1B as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started study treatment|||percentage of baseline||95% Confidence Interval|Mean
1441924|NCT00921557|Secondary|Safety as Measured by the Incidence of New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures|Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004).|Weeks 0 to 144|All participants who started treatment|||Participants|||Count of Participants
1441925|NCT00921557|Secondary|Percent Change From Baseline to Week 96 in Whole Body (With Head) BMD|Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.|Weeks 0 and 96|Includes all participants who started study treatment and had measurements available at weeks 0 and 96|||Percent change from baseline||95% Confidence Interval|Median
1442196|NCT00918866|Primary|Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose|Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose|31-35 minutes minus baseline|Per the protocol|||mm Hg||Standard Deviation|Mean
1441926|NCT00921557|Secondary|Percent Change From Baseline to Week 96 in Lumbar Spine BMD|Percent change was calculated as (measurement at week 96 - measurement at baseline)/measurement at baseline * 100%. Includes Groups 1A and 1B only.|Weeks 0 and 96|Includes all participants who started study treatment and had measurements available at weeks 0 and 96|||Percent change from baseline||95% Confidence Interval|Median
1441927|NCT00921557|Secondary|Percent Change From Baseline to Weeks 24 and 48 in Whole Body (With Head) BMD|Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Participants who started treatment and had Whole Body (with head) BMD available at week 0|||Percent change from baseline||95% Confidence Interval|Median
1441928|NCT00921557|Primary|Percentage of Participants Developing New Signs, Symptoms, Hematology or Chemistry Laboratory Values Greater Than or Equal to Grade 3 or New Cases of Jaw Osteonecrosis, Atrial Fibrillation, or Non-healing Fractures|Signs, symptoms, and laboratory values were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 (December 2004). Results for Groups 1A and 1B were combined as both were on alendronate for the first 48 weeks.|Week 0 to 48|All participants who started study treatment|||Participants|||Count of Participants
1441929|NCT00921557|Primary|Percent Change From Baseline to Weeks 24 and 48 in Lumbar Spine BMD|Percent change was calculated as (measurement at time T - measurement at baseline)/measurement at baseline * 100%. Results for Groups 1A and 1B combined as both were on alendronate for the first 48 weeks.|Weeks 0, 24 and 48|Includes all participants who started study treatment|||Percent change from baseline||95% Confidence Interval|Median
1441930|NCT00921518|Primary|Number of Participants With Acute Kidney Injury|Acuge kidney injury is defined using the AKIN criteria|5 days||||participants|||Number
1441931|NCT00921310|Secondary|Phase 2 Only: Phospho-S6 Levels in Circulating Mononuclear Cells Before and After Treatment||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
1441932|NCT00921310|Secondary|Phase 2 Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
1441933|NCT00921310|Secondary|Phase 2 Only: Survival Rate||1 year after start of treatment||||percentage of participants|||Number
1441934|NCT00921310|Secondary|Phase 2 Only: Progression-free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression.|2 years from completion of treatment|There were only (2) patients evaluable for PFS.|||days|||Number
1441935|NCT00921310|Primary|Phase I Only: Phospho-S6 Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
1441936|NCT00921310|Primary|Phase I Only: Phospho-Akt Levels in Circulating Mononuclear Cells||Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8|Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.||||||
1441937|NCT00921310|Primary|Phase I and Phase II: Overall Response Rate (Complete Response + Partial Response)|"Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.~Complete response (CR)−disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level.~Partial response (PR)−at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD"|2 years|(4) patients in Phase 1 were not evaluable for response as they were removed from study prior to week 6 scans. One patient in Phase 2 was not evaluable due to expiring prior to week 6 scans.|||percentage of participants|||Number
1441938|NCT00921310|Primary|Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLT) of Temsirolimus and Pemetrexed|"DLT will be defined as occurring within the first cycle of Phase I only and will be graded according to the Common Terminology Criteria for Adverse Events v 3.0 (CTCAE)~Any grade 3 or higher hematologic toxicity with the exception of anemia.~Any grade 3 or higher non-hematologic toxicity related to study therapy (except alopecia).~Grade 3 or 4 pneumonitis or esophagitis.~Treatment delay of temsirolimus for more than 14 consecutive days due to study-related toxicity.~Treatment delay of pemetrexed therapy for more than 14 consecutive days because of study-related toxicity."|Completion of first cycle (approximately 21 days)||||participants|||Number
1441939|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Temsirolimus That Could be Administered Weekly in Combination With Pemetrexed|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study||||mg|||Number
1441949|NCT00920907|Secondary|Number of Participants Who Developed Antibodies and Neutralizing Antibodies|Electrochemiluminescent (ECL) Immunoassay was used to detect human anti-human ipilimumab antibodies (HAHA) in serum. Blood samples were collected prior to the start of each ipilimumab infusion at Weeks 1, 4, 7, 10, 24, and at end of treatment. Those participants who were positive HAHA on treatment were then tested for presence of neutralizing antibodies.|Prior to start of drug Week 1 to Week 24 on treatment or end of treatment|Participants who received study drug and had HAHA data prior to infusion in Week 1 and while on treatment.|||participants|||Number
1441940|NCT00921310|Primary|Phase I Only: Maximum Tolerated Dose (MTD) of Pemetrexed That Could be Administered Weekly in Combination With Temsirolimus|The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.|Completion of first cycle by all enrolled patients in Phase I portion of study||||mg/m^2|||Number
1441941|NCT00921115|Primary|Pathologic Complete Response (PCR) Rate|Pathologic complete response (PCR) rate with 4 months of neo-adjuvant combination endocrine therapy (Anastrazole and Fulvestrant).|4 months|Number of participants with PCR after 4 cycles of Neoadjuvant Endocrine Therapy|||participants|||Number
1441942|NCT00921024|Primary|Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|ME: Treated patients, with baseline pathogen, complied with protocol.|||percentage of patients||95% Confidence Interval|Number
1441943|NCT00921024|Primary|Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population|Microbiological response is eradication for each baseline pathogen|TOC; 6-9 days after last study drug administration|mMITT: Treated patients, with baseline pathogen.|||percentage of patients||95% Confidence Interval|Number
1441944|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Electrolyte Laboratory Safety Tests - All Treated Participants|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 – 155; Gr 3: >155 – 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN – 130; Gr 3: <130 – 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN – 5.5; Gr 2: >5.5 – 6.0; Gr 3: > 6.0 – 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN – 3.0; Gr 2: <LLN – 3.0; Gr 3: < 3.0 – 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 – 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN – 11.5, Gr2:>11.5 – 12.5, Gr3: 12.5 – 13.5, Gr4: >13.5. Baseline is screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.|||participants|||Number
1441945|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Chemistry Laboratory Safety Tests (Non-electrolyte) - All Treated Participants|Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP); upper limits of normal (ULN). ALT Gr 1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 g/dL; Gr 2: <3.0 – 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 – 1.5*ULN; Gr 2: >1.5 – 3.0*ULN; Gr 3: >3.0– 6.0*ULN; Gr 4: >6.0*ULN. Lipase (U/L) Gr 1: 1.0 to 1.5*ULN; Gr 2: >1.5 to 2.0*ULN; Gr 3: 2.0 to 5; Gr 4: >5*ULN. Amylase (U/L) Gr 1: >ULN to 1.5*ULN; Grade 2 >1.5 to 2.0*ULN, Grade 3 >2.0 to 5.0*ULN, Grade 4 >5.0*ULN. Baseline was screening or Day 1, prior to first dose of drug.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.|||participants|||Number
1441946|NCT00920907|Secondary|Number of Participants With 2-Grade or Greater Shift From Baseline (Worsening) in Hematology Laboratory Safety Tests - All Treated Participants|Common Terminology Criteria (CTC), Version 3 used to assess parameters. Lower limit of normal (LLN); grams per deciliter (g/dL); Grade (GR); cells per microliter (c/µL). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute neutrophil (ANC) and ANC plus bands: Gr 1:<LLN to 1.5*10^3 c/µL, Gr 2:<1.5 to 1.0*10^3 c/µL, Gr 3:<1.0 to 0.5*10^3 c/µL, Gr 4:<0.5*10^3 c/µL. Platelet count Gr 1:LLN to 75.0*10^9 c/L, Gr 2:<75.0 to 50.0*10^9 c/L, Gr 3:<50.0 to 25.0*10^9 c/L, Gr 4:<25.0 to 10^9 c/L. Lymphocytes Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL. Baseline is screening or Day 1, prior to dosing.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and post baseline.|||participants|||Number
1441947|NCT00920907|Secondary|Mean Change From Baseline in Sitting Pulse Rate - All Treated Participants up to Data Cutoff|Pulse Rate was measured in beats per minute (bpm) and was obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.|||bpm||Standard Deviation|Mean
1441948|NCT00920907|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants up to Data Cutoff|Systolic and Diastolic blood pressure were measured in millimeters of mercury (mmHg) and were obtained after the participant had been seated for 5 minutes. Vital sign measurements were collected at Screening (baseline), Weeks 1, 4, 7, 10, 12, 24 and every 12 weeks thereafter in the Maintenance Phase, and at the End of Treatment visit. The change from baseline in blood pressure one hour post end of infusion at the end of induction Period, Week 36 of Maintenance Period, and end of treatment, up to data cutoff for July 2010 are presented below.|Screening to data cut off for July 2010, approximately 36 Weeks|All participants who received at least 1 dose of ipilimumab and had available data at baseline and the specific timepoint.|||mmHg||Standard Deviation|Mean
1442197|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1441950|NCT00920907|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Medical Dictionary for Regulatory Activities (MedDRA) version 15.1 was used. Note there is a difference in number of participants with an SAE in this outcome measure and the number listed in the Adverse Events Section of this document. This is because the SAEs reported in the xml upload of the Adverse Events section includes additional participants who reported SAEs after the clinical study report database was closed.|Day 1 to last patient, last visit, approximately 3 years|All participants who received at least 1 dose of ipilimumab.|||participants|||Number
1441951|NCT00920907|Secondary|Model Estimates of Mean Absolute Lymphocyte Count at Each Nominal Ipilimumab Induction Dose and at End of the Induction Dosing Period|Absolute lymphocyte counts (ALC) were obtained throughout the study as part of the hematology panel. Results collected from 28 days prior to the first infusion of ipilimumab through the end of the Induction-Dosing Period were included in the analyses of ALC. Mean ALC was estimated via an extended linear model, with linear splines and a spatial exponential within-patient correlation structure. Lymphocytes were measured as 1000 cells per micro liter (c/µL).|Day 0 (prior to first dose) to Day 84|All participants in the Pharmacodynamic data set with: (1) a baseline ALC evaluation; and (2) at least 1 post-baseline ALC evaluation (after the date of first dose).|||1000 c/µL||95% Confidence Interval|Mean
1441952|NCT00920907|Secondary|Median Overall Survival Following First Ipilimumab Dose - All Treated Participants|Overall survival (OS) was defined as the time between the first dose of study treatment and death and was analyzed using Kaplan-Meier methods, with participants who had not died censored at the last date known to be alive. Overall survival was measured in months.|Week 1 (first dose) to last patient, last visit, approximately 3 years|All participants who received at least one dose of ipilimumab.|||months||95% Confidence Interval|Median
1441953|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Immune-related (ir) Response Criteria (RC) - All Randomized Participants|ir RC=modifications of mWHO criteria reflecting clinical experience with ipilimumab in over 20 completed and/or ongoing clinical studies. irRC were designed to capture clinical activity of ipilimumab immunotherapy that may not be adequately addressed by the mWHO criteria. irComplete Response (irCR): Complete disappearance of all index and non-index lesions. irPartial Response (irPR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index and all new measurable lesions in the absence of irCR, non-index lesions not considered. irStable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (irPD). irProgressive Disease (irPD): At least 25% increase in Tumor Burden when compared to sum of the products of diameters of lesions at nadir.|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions, and for irRC, no resection of new lesions.|||participants|||Number
1441954|NCT00920907|Secondary|Best Overall Tumor Response Per Investigator Based on Modified World Health Organization (mWHO) Criteria - All Randomized Participants|Overall Response (OR) was determined as the combination of assessments of index and non-index lesions using mWHO criteria which were: Complete Response=complete disappearance of all lesions; Partial Response=decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease=does not meet criteria for complete or partial response, in the absence of progressive disease, or a decrease or tumor stabilization of one or more non-index lesions; Progressive Disease (Progression)=at least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s), or progression of non-index lesion(s). OR was measured across the entire study from Day 1 to the last patient, last visit (2009 to 2012)|Day 1 to last patient, last visit, approximately 3 years|All participants randomized to a treatment arm who received at least 1 dose of ipilimumab as randomized with measurable disease at baseline, at least one baseline assessment and one on-treatment tumor assessment, no resection of index lesions.|||participants|||Number
1441955|NCT00920907|Secondary|Volume of Distribution at Steady State (Vss) of Ipilimumab Manufactured by Process C Relative to the Vss of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Vss was measured from first dose to end of the induction period (4 doses) in liter(s) (L). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||L||Geometric Coefficient of Variation|Geometric Mean
1441956|NCT00920907|Primary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Day 21, AUC(0-21d), of Ipilimumab Manufactured by Process C Relative to the AUC(0-21d) of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. AUC(0-21d) was measured from first dose to end of the induction period as micrograms*hours per milliliter (μg*h/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1441957|NCT00920907|Secondary|Clearance (CLT) of Ipilimumab Manufactured by Process C Relative to the CLT of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. CLT was measured from first dose to end of the induction period (4 doses) in milliliters per hour (mL/h). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
1441958|NCT00920907|Secondary|Terminal Elimination Half Life (T-HALF) of Ipilimumab Manufactured by Process C Relative to the T-HALF of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. T-HALF was measured from first dose to end of the induction period (4 doses) in day(s). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||days||Standard Deviation|Mean
1441959|NCT00920907|Secondary|Time of Maximum Observed Serum Concentration (Tmax) of Ipilimumab Manufactured by Process C Relative to the Tmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|The single-dose Pharmacokinetic parameters of ipilimumab were derived from serum concentration versus time data. Tmax was measured from first dose to end of the induction period (4 doses) in hours (h). Samples were obtained at 0 h (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|PK evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||h||Full Range|Median
1441960|NCT00920907|Primary|Maximum Observed Serum Concentration (Cmax) of Ipilimumab Manufactured by Process C Relative to the Cmax of Ipilimumab Manufactured by Process B - Evaluable Pharmacokinetic Population|Single-dose Pharmacokinetic (PK) parameters of ipilimumab were derived from serum concentration versus time data. Cmax was measured from first dose to end of the induction period (4 doses) as micrograms per milliliter (μg/mL). Samples were obtained at 0 hour (predose) on Days 1, 2, 3, 4, and Weeks 2, 3, 4, 7, and 10; Day 1, samples were also obtained 1 h 30 minutes (min), 2 h, 2 h 30 min, 3 h 30 min, 4 h 30 min, and 6 h post dose. In calculating PK parameters, predose concentrations and concentrations prior to first quantifiable concentration below the lower limit of quantitation (LLOQ) were treated as “missing” for the calculation of summary statistics. Drug was quantitatively determined in serum by an enzyme-linked immunosorbent assay (ELISA). Individual PK parameter values were derived by non-compartmental methods using a validated PK analysis program (Kinetica™ 4.4.1 within eToolbox [version 2.6.1]).|Day 1 to Day 84|Pharmacokinetic (PK) evaluable Population: All participants who received at least one dose of drug and had adequate PK profiles.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1441961|NCT00920855|Secondary|Summary of Participants With Adverse Events (AEs)|Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.|up to 8.5 months. Deaths are reported up to 18 months|Safety population|||participants|||Number
1441962|NCT00920855|Secondary|Kaplan-Meier Estimate for Overall Survival (OS)|Overall survival is defined as the time from initiation of therapy to death from any cause or last follow-up visit.|up to 23 months|Safety population|||months||95% Confidence Interval|Median
1441963|NCT00920855|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response (DR) is defined as the time from the first response to progressive disease (PD). See outcome #4 for a PD definition.|up to 8.5 months|Participants who had a response|||months||95% Confidence Interval|Median
1441964|NCT00920855|Secondary|Time to the First Response|Time to first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (ie, CR, VGPR, PR, or MR).|up to 8.5 months|Participants who had a response|||months||Standard Deviation|Mean
1441965|NCT00920855|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression free survival is the time between the date of initiation of therapy to progressive disease (PD) or death from any cause, whichever occurs first. See outcome #4 for a definition of PD.|up to 23 months|Safety population|||months||95% Confidence Interval|Median
1442198|NCT00918749|Secondary|Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1441966|NCT00920855|Secondary|Kaplan-Meier Estimate for Time to Progression (TTP)|"Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following:~>25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L),~>25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h),~>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy (which must also be an absolute increase of at least 10%),~definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas,~the development of new bone lesions or soft tissue plasmacytomas,~the development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause)."|up to 8.6 months|Safety population|||months||95% Confidence Interval|Median
1441967|NCT00920855|Secondary|Participants' Best Tumor Response as Assessed by the Investigator|Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and <5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for >=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by <100 mg, and disappearance of soft tissue plasmacytomas for >= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a >=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either >=90% or to <200 mg, and >=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a >=25% and <=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.|up to 7.5 months (eight 28-day cycles)|Efficacy population|||participants|||Number
1441968|NCT00920855|Secondary|Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator|Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.|Up to 7.5 months (eight 28-day cycles)|Efficacy population|||percentage of participants||95% Confidence Interval|Number
1441969|NCT00920855|Primary|Participants With Dose Limiting Toxicity (DLT)|"Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle:~grade 4 hematologic toxicity without regard for relationship to study drug treatment~thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage~grade 3 febrile neutropenia~grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy~any study drug related grade 3 or grade 4 nonhematologic toxicity~any drug related death~Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3."|Day 1 - 28|Safety population|||participants|||Number
1441970|NCT00920829|Primary|Percent Heavy Drinking Days by mu Opioid Receptor Gene||Time Line Follow-Back drinking collected at each of 9 visits (weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16)||||percentage of days||Standard Error|Mean
1441971|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): Second-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441972|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Visual Analog Scale (VAS): First-Line Participants|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0: worst imaginable health state to 100: best imaginable health state; higher scores indicate a better health state.|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441973|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: Second-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441981|NCT00920816|Secondary|Duration of Response (DR): Second-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|DR was calculated for the subgroup of participants from the FAS previously-treated population, with a confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
1441974|NCT00920816|Other Pre-specified|Euro Quality of Life Questionnaire- 5 Dimensions (EQ-5D) Index Score: First-Line Participants|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441975|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): Second-Line Participants|FKSI-DRS: subset of FKSI which is FACT–Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441976|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms (FKSI-DRS): First-Line Participants|FKSI-DRS: subset of FKSI which is FACT–Kidney Symptom Index questionnaire used to assess QoL for participants diagnosed with renal cell cancer. FKSI contains 15 questions and FKSI-DRS 9 questions (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, hematuria) each ranging from 0 (not at all) to 4 (very much). FKSI-DRS total score 0 to 36; higher scores associated with better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441977|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): Second-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C21, end of treatment (up to Week 103), follow-up (28 days after last dose)|FAS previously-treated Asian population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441978|NCT00920816|Other Pre-specified|Functional Assessment of Cancer Therapy Kidney Symptom Index-15 (FKSI-15): First-Line Participants|FKSI-15 questionnaires (lack of energy, side effects, pain, weight loss, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria, sleep) was used to assess quality of life (QoL) for those diagnosed with renal cell cancer. Questions answered on 5-point Likert scale: 0 to 4 (0= not at all, 1= little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score 0 to 60; higher scores=better health states (Individual questions may be reversed coded, as appropriate).|Baseline (Pre-dose on Cycle [C]1 Day [D]1), D1 of each cycle until C23, end of treatment (up to Week 107), follow-up (28 days after last dose)|FAS treatment-naive population. Here ‘N’ (Number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants evaluated for this measure at specific time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1441979|NCT00920816|Secondary|Overall Survival (OS): Second-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1441980|NCT00920816|Secondary|Overall Survival (OS): First-Line Participants|Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1442012|NCT00920621|Secondary|Mass Spec Vitamin D Value From Cord Blood at Delivery|Mass Spec Vitamin D value from cord blood at delivery|Blood collection at delivery|Some measures have missing data due to collection, technical, and processing issues.|||ng/mL||Standard Deviation|Mean
1441982|NCT00920816|Secondary|Duration of Response (DR): First-Line Participants|Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|DR was calculated for the subgroup of participants from the FAS treatment-naive population, with a confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
1441983|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): Second-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1441984|NCT00920816|Secondary|Percentage of Participants With Objective Response (OR): First-Line Participants|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|FAS included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1441985|NCT00920816|Primary|Progression Free Survival (PFS): Second-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 103)|FAS included all previously-treated Asian participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1441986|NCT00920816|Primary|Progression Free Survival (PFS): First-Line Participants|"Time in months from randomization to first documentation of objective tumor progression or death due to any cause. PFS calculated as (first event date minus date of randomization plus 1)/30.4. Tumor progression determined from oncologic assessment data (where it meets criteria for progressive disease [PD]), or from adverse event (AE) data (where outcome was Death). Progression using Response Evaluation Criteria in Solid Tumors (RECIST) is >= 20 percent (%) increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions."|Baseline until disease progression or death (assessed on Week 6, Week 12 and thereafter every 8 weeks up to Week 107)|Full analysis set (FAS) included all treatment-naive participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1441987|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)||0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period).|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.|||hours||Standard Deviation|Mean
1441988|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)|Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.|||ng·h/mL||Standard Deviation|Mean
1441989|NCT00920790|Primary|Pharmacokinetics-Plasma KW-0761 Concentrations|"Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.~The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose."|0 to 7 days post final dose|Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set.|||ng/mL||Standard Deviation|Mean
1441990|NCT00920790|Secondary|Overall Survival (OS)|The time from the date of first KW-0761 dosing to the date of death.|Baseline to response|Of the 27 subjects enrolled, 26 were included in the overall survival analysis set, whereas 1 was excluded.|||days||Full Range|Median
1441991|NCT00920790|Secondary|Progression Free Survival (PFS)|"The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death.~The antitumor response criteria including PD were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG)."|Baseline to response|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.|||days||Full Range|Median
1441992|NCT00920790|Primary|Overall Response Rate (ORR)|"Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response.~The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin’s lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR."|From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months.|Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded.|||percentage of participants with response||95% Confidence Interval|Number
1441993|NCT00920699|Secondary|CoQ10 Levels|ng/ml|change from baseline to 20 weeks|data was not available for all participants to compare baseline to 20 weeks|||ng/ml||Standard Deviation|Mean
1441994|NCT00920699|Secondary|8OHdG Levels|ng/ml. Negative value signifies an decrease in 8OHdG levels|change from baseline to 20 weeks|Lab data not available for all participants to compare baseline and 20 weeks|||ng/ml||Standard Deviation|Mean
1441995|NCT00920699|Primary|Tolerability as Assessed by Ability to Complete the Study on the Originally Randomized Treatment Assignment.|No dosage modifications, reported as a %|20 weeks||||percentage of participants|||Number
1441996|NCT00920686|Secondary|24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|24 hours|Number of subjects with headache relief at 24 hours.|||Participants|||Number
1441997|NCT00920686|Secondary|4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|4 hours|Number of subjects with headache relief at 4 hours.|||Participants|||Number
1441998|NCT00920686|Secondary|2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea|"Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.~Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present~Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea"|2 hours|Number of subjects with headache relief at 2 hours.|||Participants|||Number
1441999|NCT00920686|Secondary|Headache Relief and Recurrence (Observed Cases)|"Headache relief is defined as a ≥ 1-point reduction from baseline in Headache Severity Score. The Headache Severity Score is a four-point scale: 0=no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain.~Headache recurrence is defined as any subject that experiences headache relief within 4 hours, who did not use rescue medication, and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration."|2, 4 and up to 24 hours|Number of subjects who experienced headache relief within 4 hours|||percentage of participants|||Number
1442000|NCT00920686|Primary|Time (Hours) to First Use of Rescue Medication||24 hours|The Full Analysis Set included all those subjects randomized who had dosed with study drug and had at least one (1) post study drug administration observation for headache severity. The Efficacy Evaluable Analysis Set, included all subjects with an imputed (LOCF) HSS at both the 2 hour time point and the 4 hour time point.|||hours||Inter-Quartile Range|Median
1442001|NCT00920647|Secondary|% Change From Baseline in Urinary GAG||Baseline to Week 27||||% Change||Standard Error|Mean
1442002|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Repeated Doses of Intrathecal Idursulfase-IT Given in Conjunction With Elaprase||Weeks 23|Only 1 patient out of 4 in the 1mg dose yielded sufficient data to calculate AUC.|||min*ng/mL||Standard Deviation|Mean
1442003|NCT00920647|Secondary|Concentration of Idursulfase in Serum After Single Administration (Week 3) in Conjunction With Elaprase|Values below lower limit of quantitation (LLOQ) are listed as 0.|Weeks 3|"Data were not available for the calculations in the patients of 1 mg idursulfase-IT group at Week 3.~Serum samples were not obtained from one patient in the 30mg Idursulfase-IT group at Week 3 after IV and IT administration."|||min*ng/mL||Standard Deviation|Mean
1442004|NCT00920647|Primary|Clinically Significant ECG Findings at Any Time During the Study.|Electrocardiogram (ECG) parameters included: heart rate, sinus rhythm, atrial/ventricular hypertrophy, PR, QRS, QT and QTc intervals.|6 months|Abnormalities Any Time Post-baseline ITT Population|||participants|||Number
1442005|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (Serum)||6 months|Development of antibodies post Baseline-ITT Population|||participants|||Number
1442006|NCT00920647|Primary|Safety: Development of Anti-idursulfase Antibodies (CSF)|Reflects development of anti-idursulfase antibodies post baseline.|6 months|Abnormalities Any Time Post-baseline ITT Population|||participants|||Number
1442007|NCT00920647|Primary|Safety Changes in Cerebrospinal Fluid (CSF)- White Blood Cells (WBC)|White blood cell count in CSF was monitored throughout the study as a way of assessing any potential inflammation of the meninges induced by idursulfase-IT.|6 months|Abnormalities Any Time Post-baseline ITT Population|||events|||Number
1442008|NCT00920647|Primary|Number of Treatment Emergent Adverse Event (AE)|ITT patient population|Baseline to week 23||||events|||Number
1442009|NCT00920647|Secondary|Level of Idursulfase in the CSF Compartment Resulting From Monthly Idursulfase IT Administrations|Samples collected from patients treated at doses of 1 mg and 30 mg, as well as the control group, were below the lower limit of detection of the bioanalytical method (3.13 ng/mL)|Week 27 (end of study)||||ng/mL||Standard Deviation|Mean
1442010|NCT00920647|Secondary|Change From Baseline in CSF Glycosaminoglycans [GAGs] at Week 27|Percent Change from Baseline to Week 27|Baseline to Week 27||||% change||Standard Error|Mean
1442011|NCT00920647|Primary|Number of Serious Adverse Event (SAE)||6 months|Abnormalities Any Time Post-baseline ITT Population|||events|||Number
1442013|NCT00920621|Secondary|Any Allergic Sensitization in the Child's First 3 Years of Life.|"Any allergic sensitization in the child's first 3 years of life.~*For some variables the negative count incorporates negative and indeterminate."|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
1442014|NCT00920621|Secondary|Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 3 Year Visit.|Child serum 25-hydroxyvitamin D measurement from blood collection at 3 year visit.|Blood collection at childs' 3 year visit.|Some measures have missing data due to collection, technical, and processing issues.|||ng/mL||Standard Deviation|Mean
1442015|NCT00920621|Secondary|Parental Report of Physician Diagnosis of Lower Respiratory Tract Infection in the Child's First 3 Years of Life.|Parental report of physician diagnosis of lower resperatory tract infection (LRI) in the child's first 3 years of life. LRI defined as physician diagnosed bronchitis, bronchiolitis, croup, or pneumonia ascertained from questionnaires administered every 3 months.|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Number of lower respiratory infections|||Number
1442016|NCT00920621|Secondary|Parental Report of Physician Diagnosed Eczema (With Rash) in the Child's First 3 Years of Life.|"Parental report of physician diagnosis of eczema with rash in typical distribution in the child's first 3 years of life ascertained from questionnaires administered every 3 months.~*For some variables the negative count incorporates negative and indeterminate."|Child's first 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
1442017|NCT00920621|Secondary|Child Serum 25-hydroxyvitamin D Measurement From Blood Collection at 1 Year Visit.|Child serum 25-hydroxyvitamin D measurement from blood collection at 1 year visit.|1 year visit|Some measures have missing data due to collection, technical, and processing issues.|||ng/mL||Standard Deviation|Mean
1442018|NCT00920621|Secondary|Child Positive-specific IgE Tests From Blood Collection at 3 Year Visit.|Child positive-specific IgE tests from blood collection at 3 year visit.|3 years|Some measures have missing data due to collection, technical, and processing issues.|||Positive-specific IgE tests|completed tests||Number
1442019|NCT00920621|Primary|Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling.|Maternal serum 25-hydroxyvitamin D measurement at third trimester during pregnancy|32-38 weeks gestation|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
1442020|NCT00920621|Primary|Asthma or Recurrent Wheeze in First 3 Years of Life|"Parental report of physician diagnosis of asthma or occurrence of recurrent wheeze in the child's first 3 years of life ascertained from questionnaires administered every 3 months.~*For some variables the negative count incorporates negative and indeterminate."|First 3 years of life.|Some measures have missing data due to collection, technical, and processing issues.|||Participants|||Count of Participants
1442021|NCT00920439|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
1442022|NCT00920439|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
1442023|NCT00920439|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were temperature [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = all reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite= subject did not eat at all. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
1442024|NCT00920439|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = all reports of the specified symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.|||Subjects|||Number
1442025|NCT00920426|Secondary|Day 10 Cmax, C0 and Ctau at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (Cmax, Ctau and C0) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 10|PK Summary Population.|||µg/mL/mg||90% Confidence Interval|Mean
1442026|NCT00920426|Secondary|Day 10 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following a repeat dose administration on Day 10 (AUC[0-tau]) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 10|PK Summary Population.|||hr*µg/mL/mg||90% Confidence Interval|Mean
1442027|NCT00920426|Secondary|Day 1 Cmax and C24 at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (Cmax, and C24) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 1|PK Summary Population.|||μg/mL/mg||90% Confidence Interval|Mean
1442028|NCT00920426|Secondary|Day 1 AUC(0-24) at Different Doses for the Assessment of Dose Proportionality Using Power Model|Data from GSK1265744 30 mg in HIV participants (Study ITZ111451 part C HIV cohort, NCT00659191) was combined with data from this study to access dose proportionality. Dose proportionality of GSK1265744 PK parameters was assessed following single dose administration on Day 1 (AUC[0-24]) using the power model. The mean slope and corresponding 90% confidence interval has been presented.|Day 1|PK Summary Population.|||hr*µg/mL/mg||90% Confidence Interval|Mean
1442029|NCT00920426|Secondary|Accumulation Ratios for AUC, Cmax, and Ctau|The accumulation ratio was calculated as the ratio of AUC(0-τ), Cmax, and Ctau on Day 10 to AUC(0-24), Cmax, and C24 on Day 1 for each participant. The ratio of geometric least square means of each parameter on Day 10 to Day 1 was presented along with 90% confidence interval.|Days 1 and 10|PK/ Pharmacodynamic (PD) Summary Population included participants who met the criteria for both ITT Population and PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Ratio||90% Confidence Interval|Geometric Least Squares Mean
1442030|NCT00920426|Secondary|Pre-morning Dose Concentrations (C0) on Day 2 Through 10 to Assess the Achievement of Steady State of GSK1265744 Following Repeat Administration|Steady state is said to be reached, when the pre-dose concentration slope estimate is close to zero. The data for pre-dose concentration on Day 1 24 hours (Day 2) through Day 10 has been presented.|Day 1 24 hours (Day 2), Pre-dose on Days 3, 4, 7, 8, 9 and 10|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||µg/mL||Standard Deviation|Mean
1442031|NCT00920426|Secondary|Change From Baseline in CD4+ Cell Count to Day 11|Whole venous blood samples was obtained from each participant for the analysis of lymphocyte subsets by flow cytometry on Day 1 and Day 11. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Cells per cubic millimeter||Standard Deviation|Mean
1442032|NCT00920426|Secondary|Number of Participants With HIV-1 RNA<50 Copies/mL|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.|Up to Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
1442033|NCT00920426|Secondary|Number of Participants With HIV-1 RNA<400 Copies/mL|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.|Up to Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
1442034|NCT00920426|Secondary|Plasma HIV-1 RNA Rate of Decline (Slope) Over 11 Days|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Estimated mean rate of decline (i.e., slope of day) with corresponding 90% confidence interval was provided for each treatment.|Up to Day 10|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||log10 copies per mL per day||90% Confidence Interval|Mean
1442035|NCT00920426|Secondary|Change From Baseline in Plasma HIV-1 RNA to Nadir Over 11 Days|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Nadir was the maximum change from Baseline in plasma HIV-1 RNA. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 11|ITT population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||log10 copies/mL||Standard Deviation|Mean
1442046|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Red Blood Cell Count|Blood samples for assessment of hematology parameter of red blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Million cells per microliter||Standard Deviation|Mean
1442036|NCT00920426|Secondary|Change From Baseline in Plasma HIV-1 RNA|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA were collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a LLOD of 50 copies/mL (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1 pre-dose) and Day 1 (post dose), 2, 3, 4, 7, 8, 9, 10|ITT population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Log10 copies/mL||Standard Deviation|Mean
1442037|NCT00920426|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters|All ECGs were obtained after a minimum 10 minute rest in a semi-supine position. The 12-lead ECGs were obtained at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10 using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and Bazett’s correction (QTcB) and Fridericia correction (QTcF) intervals. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Milliseconds (msec)||Standard Deviation|Mean
1442038|NCT00920426|Primary|Change From Baseline in Vital Sign: Heart Rate|Heart rate was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Beats per minute||Standard Deviation|Mean
1442039|NCT00920426|Primary|Change From Baseline in Vital Sign: Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure was measured at Baseline (Day 1 pre-dose), 2 hour post dose on Day 1, pre-dose on Day 4, 7, 10 and 2 hours post dose on Day 10. Baseline was defined at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1, pre-dose) and Day 1 (2 hours post dose), 4, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1442040|NCT00920426|Primary|Number of Participants With Urinalysis Data|Samples for urinalysis assessment was collected on Day 1, Day 3 and Day 10. Urinalysis parameters included urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine pH, urine protein, urine specific gravity and urine leukocyte esterase test for detecting white blood cell.|Day 1 to Day 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
1442041|NCT00920426|Primary|Change From Baseline in Clinical Chemistry Data: Chloride, Carbon Dioxide Content/Bicarbonate, Magnesium, Sodium, Potassium|Blood samples for assessment of clinical chemistry parameters of chloride, carbon dioxide content/bicarbonate, magnesium, sodium and potassium was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Milliequivalents per liter||Standard Deviation|Mean
1442042|NCT00920426|Primary|Change From Baseline in Direct Bilirubin, Total Bilirubin, Calcium, Cholesterol, Creatinine, Glucose, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, Triglycerides, Urea/Blood Urea Nitrogen|Blood samples for assessment of clinical chemistry parameters of direct bilirubin, total bilirubin, calcium, cholesterol, creatinine, glucose, HDL cholesterol direct, LDL cholesterol calculation, triglycerides,Urea/BUN was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Milligrams per deciliter||Standard Deviation|Mean
1442043|NCT00920426|Primary|Change From Baseline in Clinical Chemistry Data: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Lipase|Blood samples for assessment of clinical chemistry parameters of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and lipase was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. Only those participants available at the indicated time points were analyzed. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Units per liter||Standard Deviation|Mean
1442044|NCT00920426|Primary|Change From Baseline in Clinical Chemistry Data: Albumin, Total Protein|Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Grams per deciliter||Standard Deviation|Mean
1442045|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Reticulocytes|Blood samples for assessment of hematology parameter of reticulocytes was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Giga cells per liter||Standard Deviation|Mean
1442047|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Platelet Count|Blood samples for assessment of hematology parameter of platelet count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Cells per cubic millimeter||Standard Deviation|Mean
1442048|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Mean Corpuscle Volume|Blood samples for assessment of hematology parameter of mean corpuscle volume was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Femtoliter||Standard Deviation|Mean
1442049|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Mean Corpuscle Hemoglobin|Blood samples for assessment of hematology parameter of mean corpuscle hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Picogram||Standard Deviation|Mean
1442050|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Hemoglobin|Blood samples for assessment of hematology parameter of hemoglobin was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Grams per deciliter||Standard Deviation|Mean
1442051|NCT00920426|Primary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC- Absolute Neutrophil Count), White Blood Cell Count|Blood samples for assessment of hematology parameters of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC- absolute neutrophil count) and white blood cell count was collected at Baseline, Day 3, 7 and 10. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 3, 7, 10|Safety population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Thousand cells per microliter||Standard Deviation|Mean
1442052|NCT00920426|Primary|Number of Participants With Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or is associated with liver injury and impaired liver function.|Day 1 to Day 11|Safety population was defined as all participants who were randomized into the study with documented evidence of having received at least 1 dose of randomized treatment. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Participants|||Count of Participants
1442053|NCT00920426|Primary|GSK1265744 PK Parameters Following Last Repeat Administration on Day 10: Apparent Clearance Following Oral Dosing (CL/F)|Blood samples for PK analysis of CL/F of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1442054|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Terminal Half-life (t1/2) and Absorption Lag Time (Tlag)|PK sampling was planned to be collected up to 24 hours only on Day 1 and Day 10. The data for this outcome measure was however not collected.|Day 1 and Day 10|PK Summary Population. Data for this outcome measure was not collected. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.||||||
1442055|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Time to Cmax (Tmax)|Blood samples for PK analysis of tmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Hour||Full Range|Median
1442056|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1 and Day 10: Maximum Observed Concentration (Cmax)|Blood samples for PK analysis of Cmax of GSK1265744 was collected at pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10. Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Pre-dose (within 15 minutes prior to dosing) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose on Days 1 and 10|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1442069|NCT00920374|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
1442070|NCT00920374|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
1442057|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 10: Predose Concentration (C0), Concentration at End of Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin)|Blood samples for PK analysis of C0, Ctau and Cmin of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK Summary Population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1442058|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 10: Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau])|Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 10 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||hr*µg/mL||Geometric Coefficient of Variation|Geometric Mean
1442059|NCT00920426|Primary|GSK1265744 PK Parameters Following Dose Administration on Day 1: Concentration at 24 Hours Post Dose (C24)|Blood samples for PK analysis of C24 of GSK1265744 was collected on Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded.|Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK summary population. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1442060|NCT00920426|Primary|GSK1265744 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments(AUC[0-24])|Blood samples for PK analysis of AUC(0-24) of GSK1265744 was collected on Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose). Samples were collected at nominal times relative to the proposed time of GSK1265744 dosing. The actual date and time of each blood sample collection was recorded. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Day 1 (Pre-dose [within 15 minutes prior to dosing] and at 0.5, 1, 1.5, 2, 3, 4, 6, and 8hours post-dose)|PK Summary Population included participants with evaluable PK profile of GSK1265744 on Day 10. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||Hour*microgram per milliliter (hr*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1442061|NCT00920426|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) to Day 11|Plasma for quantitative HIV-1 RNA was collected on Day 1, 2, 3, 4, 7, 8, 9, 10 and 11. On Days 1, 10 and 11, two samples for HIV-1 RNA was collected between 5-20 minutes apart to reduce sample variability. An HIV-1 RNA PCR assay with a lower limit of detection (LLOD) of 50 copies/milliliter (mL) (ultrasensitive assay) was used for post-baseline assessments. An HIV-1 RNA PCR assay with a LLOD of 400 copies/mL (standard assay) was used for screening and Baseline assessments and included a re-test with and ultrasensitive assay for all Baseline values below the LLOD. Baseline was defined at Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) and Day 11|Intent-to-treat (ITT) population comprised of all participants who met study criteria and randomized into study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post-baseline HIV-1 RNA measurement. GSK1265744 30 mg arm is from study ITZ111451 that was used only for dose proportionality assessments.|||log10 copies/mL||Standard Deviation|Mean
1442062|NCT00920374|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the entire study period||||subjects|||Number
1442063|NCT00920374|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||subjects|||Number
1442064|NCT00920374|Primary|Seroconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||fold increase||95% Confidence Interval|Mean
1442065|NCT00920374|Primary|Number of Seroconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||subjects|||Number
1442066|NCT00920374|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||subjects|||Number
1442067|NCT00920374|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data|||subjects|||Number
1442068|NCT00920374|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1442071|NCT00920374|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|Day 0 and Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data|||titer||95% Confidence Interval|Geometric Mean
1442072|NCT00920309|Secondary|Glomerular Filtration Rate (Kidney Function)||2 years|Outcome measures were not analyzed due to study termination||||||
1442073|NCT00920309|Primary|Total Kidney Volume (mL)||2 years|Outcome Measures were not analyzed due to study termination||||||
1442074|NCT00920231|Secondary|Ability to Meet the Subjective Travel Needs of the Blind Subject|This is a subjective rating that incorporates user friendliness of the system and the specific needs of the subject. The subject is asked to rate whether the device meets his or her travel needs on a 1 to 7 scale with 1 being excellent and 7 being very poor.|no time limit||||units on a scale||Standard Error|Mean
1442075|NCT00920231|Primary|Frequency of Device Failures Per Attempt to Complete a Navigation Course|device failures were defined as any failure to provide correct location and direction information at thre appropriate time, resulting in a mistake that needed the initial prototype's ability to meet their travel needs at a good to excellent range.|The subject is given as much time as needed to complete the task||||number of device failures per attempt||Standard Error|Mean
1442076|NCT00920218|Secondary|Number of Subjects With Confirmed Herpes Zoster (HZ) Cases|A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as ‘a confirmed case of HZ’ or ‘not a case of HZ’ based on the determination by the GSK responsible physician of the study.|During the entire study period (from Day 0 to Month 15)|he analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442077|NCT00920218|Secondary|Anti-gE Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||Standard Deviation|Mean
1442078|NCT00920218|Secondary|Anti-gE Geometric Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
1442079|NCT00920218|Secondary|VZV-specific Mean Antibody Concentrations|Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3, 4 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||Standard Deviation|Mean
1442080|NCT00920218|Secondary|Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Months 0, 1, 2, 3, 4 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
1442081|NCT00920218|Secondary|Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines|The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).|At Months 0, 1, 2, 3 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
1442082|NCT00920218|Secondary|Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens|The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).|At Months 0, 1, 2, 3, 4 and 15|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||VZV specific CD4+ T-cells/million Tcells||Standard Deviation|Mean
1442083|NCT00920218|Primary|Anti-gE Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||Standard Deviation|Mean
1442084|NCT00920218|Primary|Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||mIU/mL||95% Confidence Interval|Geometric Mean
1442127|NCT00919867|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
1442972|NCT00912158|Secondary|Arterial Blood Gases, Respiratory Rate, Blood Pressure, Cardiac Output ,Intrapulmonary Shunt, A-a Oxygen Gradient, Heart Rate, and Dyspnea Duration of Hospital and ICU Stay and Mortality||Hospital stay||2010-01-31|01/2010||||
1442085|NCT00920218|Primary|Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines|The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma [IFN-γ], Interleukin 2 [IL-2], Tumour Necrosis Factor alpha [TNF-α] and/or CD40 Ligand [CD40L] as determined by in vitro intracellular cytokine staining (ICS).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
1442086|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 4|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442087|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 3|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442088|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 2|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442089|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 1|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442090|NCT00920218|Primary|Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 0|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442091|NCT00920218|Primary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders|Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|During the entire study period (from Day 0 to Month 15)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442092|NCT00920218|Primary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders|Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|Within the 30-day (Days 0-29) post last vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442093|NCT00920218|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Month 15)|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442094|NCT00920218|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Any time during the study up to Day 29 after the last vaccination|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442095|NCT00920218|Primary|Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities.|During the 30-day (Days 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1442096|NCT00920218|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [including nausea, vomiting, diarrhoea and abdominal pain], temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-days (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1442097|NCT00920218|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-days (Days 0-6) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1442098|NCT00920140|Secondary|Overall Survival by Cohort|Overall survival is defined as the time from the start of study treatment (GSK1120212) until death due to any cause. For the analysis of overall survival, the last date of known contact was used for those participants who had not died at the time of analysis; such participants were considered censored.|From the start of the study drug until the final study visit (up to approximately 407 days )|Efficacy Population. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).|||Months||90% Confidence Interval|Median
1442099|NCT00920140|Secondary|Ctau of GSK1120212 in Part 2|Ctau is the pre-dose (trough) concentration at the end of the dosing interval and was measured for Cycle 1 Day 15 (C1D15), Cycle 2 Day 1(C2D1), Cylce 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), Cycle 7 Day 1 (C7D1), Cycle 8 Day 1 (C8D1), Cycle 9 Day 1 (C9D1), Cycle 10 Day 1 (C10D1), Cycle 11 Day 1 (C11D1) and Cycle 12 Day 1 (C12D1). Blood samples for PK analysis were collected pre-dose (i.e., no later than 15 min prior to dosing).|C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1 and C12D1|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1442100|NCT00920140|Secondary|Accumulation Ratio (AR) of GSK1120212 in Part 1|AR is the ratio of the Day 15 AUC0-tau (0 hour to last dose interval) and Day 1 AUC0-tau (AUCtau C1D15/AUCtau C1D1). Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1442101|NCT00920140|Secondary|Tmax of GSK1120212 in Part 1|Tmax is defined as the time to reach the observed maximum concentration and was measured for C1D1 and C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||Hours||Full Range|Median
1442102|NCT00920140|Secondary|t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half and was measured for C1D1. t1/2eff. is defined as the effective half-life and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff)|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1442103|NCT00920140|Secondary|Cmin and Cmax of GSK1120212 in Part 1|Cmax is defined as the maximum observed concentration of GSK1120212 and was measured for C1D1 and C1D15. Cmin is defined as the minimal observed concentration of GSK1120212 and was measured for C1D15. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 min before study drug administration) and at 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1442128|NCT00919867|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-amphetamine. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
1442199|NCT00918749|Secondary|Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|ITT Population|2 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1442104|NCT00920140|Secondary|AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 24 hours (AUC[0-24]) for Cycle 1 Day 1 (C1D1), from time zero to the last time of a quantifiable concentration (AUC[0-t]) for C1D1 and Cylce 1 Day 15 (C1D15) and AUC curve over the dosing interval AUC[0-tau] for C1D15 were measured. Blood samples for PK analysis were taken on Day 1 and Day 15 (within 30 minutes [min] before study drug administration) and at 0.5 hour (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 24 h post-dose. All other PK sampling were done pre-dose (i.e., within 30 min before study drug administration).|Cycle 1 Day 1 and Cycle 1 Day 15|Pharmacokinetic Population: all participants included in the All Treated Population for whom a PK sample was obtained and analyzed. Only participants with data available at the indicated time points were analyzed.|||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
1442105|NCT00920140|Primary|Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort|Overall response rate (ORR=CR+CRp+Marrow CR+MLFS+PR) was calculated from the investigator’s assessment of response recorded within the first eight weeks of treatment. CR includes complete remission. Complete remission is a state in which the participant must be free of all symptoms related to leukemia and have an absolute neutrophil count >=1 x 10^9/L, platelet count >=100 x 10^9/L, and normal marrow differential (<=5% blasts). PR includes partial remission. Partial remission is a state in which the participant has a CR with 6 to 25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. CRp is as per CR but platelet count <100 x 10^9/L. MLFS is a state in which the participant has a normal marrow differential (<5% blasts), neutrophil, and platelet counts are not considered.|From the start of the study drug until the final study visit (up to approximately 407 days)|Efficacy Population: all participants included in the All Treated Population who had received at least one dose of 2 mg of study drug in Phase 2. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30).|||Participants|||Number
1442106|NCT00920140|Primary|Number of Participants With a Change From Baseline in Temperature by Dose|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants (par.) are counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
1442107|NCT00920140|Primary|Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3/4 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3/4 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values are assumed to have a Baseline value of grade 0. Only those participants (par.) with blood pressure values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
1442108|NCT00920140|Primary|Number of Participants With a Change From Baseline in Heart Rate by Dose|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants are counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-baseline. Only those participants (par.) with heart rate values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
1442109|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose|Hematology and clinical chemistry data were summarized according to NCI-CTCAE grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, bicarbonate, potassium, magnesium, sodium, and phosphorus. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
1442129|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in CD4+ Percentage||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Percentage of lymphocytes||Standard Error|Mean
1442110|NCT00920140|Primary|Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose|Hematology and clinical chemistry data were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 3.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe; Grade 4, Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, international normalized ratio (INR), lymphocytes, total neutrophils, platelet count, and partial thromboplastin time (PTT). Participants with missing baseline grades were assumed to have a baseline grade of 0. Only those participants (par.) with laboratory values for worst-case on-therapy (defined as the worst shift that occurred at any time during the treatment period) are presented.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
1442111|NCT00920140|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose|An AE is any untoward medical occurrence in a participant (par.) or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of the study drug until the final study visit (up to approximately 407 days)|All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received <2 mg [0.5 mg]); thus, 6 par. receiving GSK1120212 <2 mg OD were analyzed.|||Participants|||Number
1442112|NCT00920075|Secondary|Number of Participants With Fracture|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.|Post study (1-6 years), one clinical visit|11 participants responded to participate in the post study. During their one clinic visit, their fracture history during the period before coming to the post study was obtained.|||participants|||Number
1442113|NCT00920075|Secondary|Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.|Post study (1-6 years), one clincial visit|11 participants responded to participate in the post study. Their bone density of Hip was measured by DXA scan. Increase in percentage density of Hip was obtained from that of previous values. One participant showed a slight decrease in bone density.|||participants|||Number
1442114|NCT00920075|Primary|Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).|Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.|Post study (1-6 yrs), one clinical visit|Participants who earlier completed our phase I or phase II study on alendronate in juvenile osteoporosis, were invited to participate in the current post study evaluation of bone density and fractures.|||participants|||Number
1442115|NCT00920023|Primary|To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.|Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative.|3 years||||Percentage of true negative sample||95% Confidence Interval|Number
1442116|NCT00920023|Primary|To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.|Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive.|3 years||||percentage of positive cases||95% Confidence Interval|Number
1442117|NCT00919932|Secondary|Exit Interview|Verbal interview|1 month||||participants|||Number
1442118|NCT00919932|Primary|Therapy Homework Compliance: Percent Homework Completed|Number of thought logs completed over the course of the 4 week trial.|1 month||||homework sheets completed||Standard Deviation|Mean
1442119|NCT00919893|Primary|Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)|Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.|0, 6, 12 weeks|ITT (Intention to treat) LOCF (Last observation carried forward)|||participants|||Number
1442120|NCT00919893|Secondary|Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.|Decrease of score points. Decrease of leucocytes in urine.|0, 6, 12 weeks||||participants|||Number
1442121|NCT00919867|Primary|T 1/2 of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1442122|NCT00919867|Primary|Tmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1442123|NCT00919867|Primary|AUC of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
1442124|NCT00919867|Primary|Cmax of d-Amphetamine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng/ml||Standard Deviation|Mean
1442125|NCT00919867|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1442126|NCT00919867|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1442130|NCT00919854|Secondary|Mean Change From Baseline to Week 24 and Week 48 in Plasma log10 Viral Load||Baseline, Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||log10 copies/mL||Standard Error|Mean
1442131|NCT00919854|Secondary|Number of Participants With Less Than or Equal to 1 log10 Decrease in Plasma Viral Load at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
1442132|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 400 Copies/mL) at Week 24 and Week 48||Week 24 and Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
1442133|NCT00919854|Secondary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 48||Week 48|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
1442134|NCT00919854|Primary|Number of Participants With Virological Response (Viral Load Less Than 50 Copies/mL) at Week 24 - Time to Loss of Virologic Response (TLOVR)|The TLOVR algorithm was used to derive response, ie, response and loss of response needed to be confirmed at 2 consecutive visits and participants who permanently discontinued were considered nonresponders after discontinuation. Participants with intermittent missing viral load values were considered responders if the preceeding and succeeding visits indicated response. In all other cases, intermittent values were imputed with nonresponse. Resuppression after confirmed virologic failure was considered as failure in this algorithm.|Week 24|27 participants were recruited and received at least 1 dose of study medication; as Good Clinical Practice (GCP) requirements were not consistently adhered to at one site (involving 6 participant), analyses were performed excluding the participants from this site, resulting in 21 participants used for analyses.|||Participants|||Number
1442135|NCT00919802|Secondary|Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration|A verbal anxiety report (VAR; 0-10 with 0 being no anxiety and 10 being the worst possible anxiety); a change from baseline measure was calculated for value measured 6 hours post drug/placebo administration|6 hours post drug or placebo administration||||units on a scale||Standard Error|Mean
1442136|NCT00919802|Primary|Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours|This is a seven-point symmetric scale previously validated for use in IC studies in which patients are asked relative to baseline (over the last 6 hours for purposes of this study), -3 -are you markedly worse, -2 -moderately worse, -1 -slightly worse, 0-no change, +1-slightly improved, +2-moderately improved, or +3-markedly improved. A +2 or +3 can be defined categorically as a positive treatment response|6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data||||units on a scale||Standard Error|Mean
1442137|NCT00919763|Secondary|Percent Change in TSS||from Baseline to Week 4|||||||
1442138|NCT00919763|Primary|Total Sum Score (TSS)of Target Lesion|"Total Sum Score (TSS) on the Target Lesion at Week 4 or Early Termination adjusted on Baseline (Sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification of Target Lesion).~Scale values range from 0 - 3; 0 is minumal (best) and 3 is maximum (worst). Unit is used as score on a scale. Total possible minimum score is 0. Total possible maximum score is 15."|at Week 4|intention to treat (ITT) Last Observation Carried Forward (LOCF)|||Scores on a scale||Standard Error|Least Squares Mean
1442139|NCT00919724|Primary|Endothelial Function (Brachial Artery Reactivity)|The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.|Single measurement||||percent dilation||Standard Deviation|Mean
1442140|NCT00919711|Secondary|Lumbar Spine BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation|||Percent Change From Baseline||95% Confidence Interval|Mean
1442141|NCT00919711|Secondary|Femoral Neck BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation|||Percent Change From Baseline||95% Confidence Interval|Mean
1442142|NCT00919711|Secondary|Serum CTX Percent Change From Baseline at Month 1|Serum Type-1 Collagen C-Telopeptide Percent Change From Baseline at Month 1|Baseline to month 1|All randomized subjects who enrolled in the bone marker substudy with observed data|||Percent Change From Baseline||Inter-Quartile Range|Median
1442143|NCT00919711|Primary|Total Hip BMD Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry|Baseline to month 12|All randomized subjects excluding those with missing post baseline data and missing covariate for regression imputation|||Percent Change From Baseline||95% Confidence Interval|Mean
1442144|NCT00919633|Secondary|Viral Decay||12 weeks of treatment|||||||
1442145|NCT00919633|Secondary|Functional Health, Depression Score, and Fatigue Level||through Study Week 72|||||||
1442146|NCT00919633|Secondary|Pharmacodynamics||through Study Week 72|||||||
1442147|NCT00919633|Secondary|Pharmacokinetics||through Study Week 72|||||||
1442148|NCT00919633|Secondary|End-of-treatment Response (EOT)||Study week 48|||||||
1442149|NCT00919633|Secondary|Early Virologic Response (EVR)||Study week 12||||participants|||Number
1442150|NCT00919633|Secondary|Rapid Virologic Response (RVR)||Study Week 4||||participants|||Number
1442151|NCT00919633|Primary|Safety/Tolerability||Through study week 72|||||||
1442154|NCT00919191|Primary|Comparative Assessment of Facial Irritation and Cutaneous Effects.|Expert Grader Assessment, including cumulative scores for Erythema and Dryness on a scale of 0=none to 8=severe|Daily, for 3 weeks|All participants used both gels concurrently, on opposite sides of the face (split-face model)|||Scores on a Scale||Standard Deviation|Mean
1442155|NCT00919126|Secondary|Serum Chemistry - Urea (mmol/L)|Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||mmol/L||Standard Deviation|Mean
1442156|NCT00919126|Secondary|Serum Chemistry - Creatinine (Mcmol/L)|Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||mcmol/L||Standard Deviation|Mean
1442157|NCT00919126|Secondary|Serum Chemistry - Gamma GT (IU/L)|Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients)|||IU/L||Standard Deviation|Mean
1442158|NCT00919126|Secondary|Serum Chemistry - ALT (GPT) (IU/L)|ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||IU/L||Standard Deviation|Mean
1442159|NCT00919126|Secondary|Serum Chemistry - AST (GOT) (IU/L)|AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||IU/L||Standard Deviation|Mean
1442160|NCT00919126|Secondary|Haematology - Platelets (Giga/L)|Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||Giga/L||Standard Deviation|Mean
1442161|NCT00919126|Secondary|Haematology - Erythrocytes (Tera/L)|Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day.|The analysis was done in the ITT Data Set (Randomised Patients).|||Tera/L||Standard Deviation|Mean
1442162|NCT00919126|Secondary|Haematology - Leucocytes (Giga/L)|Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||Giga/L||Standard Deviation|Mean
1442163|NCT00919126|Secondary|Stay in the Recovery Room|Time interval between admission in the recovery room and discharge from the recovery room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
1442164|NCT00919126|Secondary|Stay in the Operating Room|Time interval between admission in the operating room and discharge from the operating room.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
1442165|NCT00919126|Secondary|Awakening Time|Time interval between the end of maintenance period and time of Aldrete score ≥ 9.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
1442166|NCT00919126|Secondary|Anaesthesia Recovery Time|Time interval between the end of maintenance period and time of tracheal tube removal.|1 Postoperative Day|The analysis was done in the ITT Data Set (Randomised Patients).|||minutes||Standard Deviation|Mean
1442167|NCT00919126|Primary|Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)|Dose of propofol administered with a Target Controlled Infusion (TCI) device, cerebral concentration equal to 5 µg/mL at the end of induction, and then concentration adjusted to the level of depth of anaesthesia during maintenance. Depth of anaesthesia continuously assessed by signals derived from electroencephalographic recording. Analgesia during induction and maintenance obtained with remifentanil administered with a second TCI device at the stable cerebral concentration of 7 ng/mL.|Maintenance period (1 Day)|The main analysis was done in the ITT Data Set (Randomised Patients).|||mg adjusted||Standard Deviation|Mean
1442168|NCT00919113|Secondary|Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.|Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF|at week 11|Efficacy analysis performed according to randomized treatment.|||participants|||Number
1442169|NCT00919113|Primary|Global Response Assessment (GRA) Responders at Week 11.|"subjects that indicated markedly improved or moderately improved on the GRA, LOCF"|at week 11|Efficacy analysis performed according to randomized treatment.|||participants|||Number
1442170|NCT00919061|Primary|Median PFS|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 mos||||months||95% Confidence Interval|Median
1442171|NCT00919061|Primary|Progression-Free Survival|Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.|6 months||||percentage of participants||95% Confidence Interval|Number
1442172|NCT00919035|Secondary|Does the Prostate Specific Antigen (PSA) Doubling Times Change Before and After Treatment|PSA Doubling time is defined as the length of time that it takes for an individual patients PSA to double. PSA doubling times were calculated using the medial records at study entry for each patient. While the patient was on study their PSA doubling times were also calculated.|evaluate PSA doubling time pre study to actual doubling time while on study - calculated from start of study up to 10 cycles or 40 weeks.|PSA doubling time pre study was compared to PSA doubling time while the patients are on study, per protocol.|||percentage of participants|||Number
1442173|NCT00919035|Secondary|Time to Disease Progression|Time to disease progression is defined as the length of time from when the patient starts the study till disease progression. Disease progression is defined as more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies. Or the appearance of 2 or more new bony lesions on a bone scan. Or newly developed cord compression or pathologic fracture.|Disease progression is assessed every 2 months, for up to 40 weeks, measured from day one of protocol treatment until the date the patient is off study.||||months||Full Range|Mean
1442200|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population|ITT Population|4 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1442174|NCT00919035|Primary|Overall Clinical Benefit From Torisel® in Chemotherapy-naïve Castration Resistant Prostate Cancer (CRPC).|The overall clinical benefit is defined as the sum of complete response (CR), partial response (PR), and stable disease (SD). CR: is the disappearance of all measurable lesions including bone lesions detected on the bone scan, no evidence of new lesions, and no disease-related symptoms. PR: More than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. SD: Lesions should have no sufficient decrease for PR or CR and no sufficient increase to meet criteria for Progressive Disease (PD). PD: > 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies OR The appearance of 2 or more new bony lesions on a bone scan is satisfactory for PD. Newly developed cord compression or pathologic fracture is defined as PD.|disease progression is assessed every 2 cycles, for up to 40weeks, per protocol, from the date of the first dose of study drug to the date the patient is taken off study||||percentage of participants|||Number
1442175|NCT00918957|Primary|Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier|Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.|||change in percentage||Standard Error|Least Squares Mean
1442176|NCT00918957|Primary|Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29)|"Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.~In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error.~﻿Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.|||change in percentage||Standard Error|Least Squares Mean
1442177|NCT00918957|Secondary|Tobramycin Serum Concentration|"Descriptive statistics of serum and sputum concentrations per scheduled sampling time.~Detectable concentration values at pre-dose on Day 1 were excluded from the analysis."|Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose|"Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.~This measures the concentration of active substance in the body at different time-point to evaluate there is abnormal accumulation of active substance. Not for Placebo Patients."|||μ﻿g/mL||Standard Deviation|Mean
1442178|NCT00918957|Secondary|Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug|"Relative change = 100 * (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose.~Day 1 is the scheduled visit of first study drug administration."|Day 1, Day 29|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received.|||Percentage of participants|||Number
1442179|NCT00918957|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|"Serious Adverse Events (on and off treatment) by preferred term and treatment group.~Preferred terms are sorted in descending order of frequency in the TIP treatment group.~A patient with multiple occurrences of the same preferred term is counted only once in the preferred term."|Time of consent, 4 weeks after study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.|||percentage of participants|||Number
1442180|NCT00918957|Secondary|Percentage of Participants With Adverse Events (AEs)|"Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group.~Primary system organ classes are sorted in descending order of frequency in the TIP treatment group.~A patient with more than one AE within a primary system organ class is counted only once for that class."|First administration of study drug, study completion|Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received|||Percentage of participants|||Number
1442181|NCT00918957|Secondary|Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal|"Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline.~Biochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline."|Baseline, Study completion|Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received.|||percentage of participants at risk|||Number
1442182|NCT00918957|Secondary|Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC)|Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group.|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||μg/mL||Standard Deviation|Mean
1442201|NCT00918749|Secondary|Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population|ITT Population|3 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1442183|NCT00918957|Secondary|Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum)|"P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant).~If sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed."|Baseline, Day 29, Day 57|﻿Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Log10 CFU (colony forming unit)||Standard Error|Mean
1442184|NCT00918957|Secondary|Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57)|"﻿FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity~For FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value."|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||percentage change||Standard Error|Least Squares Mean
1442185|NCT00918957|Secondary|Change From Baseline of ﻿Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57)|"Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication.~Response (percentage change) = treatment + Screening FEV1 percentage predicted (<50 and >=50) + age (<13 and >=13) + error"|Baseline, Day 29, Day 57|Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||percentage change||Standard Error|Mean
1442186|NCT00918957|Primary|Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29)|"Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model.~ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero.~BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication~- Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses."|Baseline, Day 29|ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded.|||change in percentage||Standard Error|Least Squares Mean
1442187|NCT00918931|Primary|Response Rate|Response rate is defined as number of participants with objective response divided by number of participants evaluated. Objective response is complete response and partial response where 'complete response' constitutes total elimination of a symptom or sign of the disease; 'partial response' constitutes at least 50% improvement in a symptom or sign of the disease. Objective response definitions of response evaluated following guidelines proposed by Valent et al. (International working group consensus criteria).|3-Month Response Evaluation|Analysis was per protocol.|||participants|||Number
1442188|NCT00918879|Secondary|Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24|Proportion of participants (expressed in percentage of total participants)achieving HbA1c < 7.0% for saxagliptin versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||Percentage of Participants|||Number
1442189|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mmol/L||Standard Error|Mean
1442190|NCT00918879|Secondary|Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||mg/dL||Standard Error|Mean
1442191|NCT00918879|Primary|Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)|Adjusted* mean change from baseline in glycosylated haemoglobin A1c (HbA1c) achieved with saxagliptin 5 mg versus placebo at Week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the Week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.|Baseline , Week 24|Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.|||percent||Standard Error|Mean
1442192|NCT00918866|Secondary|Immunology Panel- Tryptase|Evaluate the Immunology Panel after the administration of DEFINITY|Out to 70 minutes||||ug/ml||Standard Deviation|Mean
1442202|NCT00918749|Secondary|Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population|Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.|2 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1442203|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population||3 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1442204|NCT00918749|Secondary|Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population||2 months|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1442205|NCT00918749|Primary|Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population|Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.|Month 4|ITT Population|||Percent Change from Baseline||Standard Error|Least Squares Mean
1442206|NCT00918736|Secondary|Rescue Acetaminophen Consumption|The use of all analgesic medication during the study period was recorded on a diary card by the patient.|6 months||2009-10-31|10/2009||||
1442207|NCT00918736|Secondary|Systemic and Local Adverse Events Recording|he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card|6 months||2009-10-31|10/2009||||
1442208|NCT00918736|Secondary|the Level of Global Satisfaction Based on a 7-point Categorical Scale|The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.|6 months||2009-10-31|10/2009||||
1442209|NCT00918736|Secondary|Four Clinical Balance Tests|Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed “ Up-and-Go” test (TUG) ,Berg Balance Scale (BBS)|6 months||2009-09-30|09/2009||||
1442210|NCT00918736|Secondary|Ankle Sagittal Range of Motion|Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.|6 months||2009-09-30|09/2009||||
1442211|NCT00918736|Secondary|The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score|The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment|6 months||2009-10-31|10/2009||||
1442212|NCT00918736|Primary|Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months|The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable|baseline and 6 months|The statistical analysis was done on completers.|||score on a scale||Standard Deviation|Mean
1442213|NCT00918723|Secondary|To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat|Responses were measured after completion of FCR+ vorinostat induction therapy (within 21 days of starting maintenance) and again after completion of maintenance therapy (24 months after the start of maintenance therapy). Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat. Criteria for response are specified by the National Cancer Institute (NCI) working group guidelines; in addition, patients were required to meet computed tomography (CT) criteria as described in the protocol. Response categories include Complete Response (CR), Partial Response (PR), Nodular Partial Response (nPR), Stable Disease (SD) or Progressive Disease (PD).|After completion of maintenance therapy (24 months after start of maintenance)|Participants who had a partial response (PR) or nodular partial response (nPR) after FCR+vorinostat induction therapy, as measured within 21 days of starting maintenance therapy. Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat.|||percentage of participants|||Number
1442214|NCT00918723|Secondary|To Eliminate Residual Disease (Documented by Flow Cytometry and/or Polymerase Chain Reaction [PCR]) in Patients Who Have Achieved Complete Response (CR) After Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Vorinostat||Within 21 days prior to starting maintenance therapy|Patients who achieved a complete response (CR) after induction therapy and had minimal residual disease (MRD) status tested using flow cytometry|||Participants|||Count of Participants
1442215|NCT00918723|Primary|Overall Survival|Overall survival (OS): The percentage of people in a study who are still alive at for a certain period of time after they started treatment.|2 years||||percentage of participants||95% Confidence Interval|Number
1442216|NCT00918723|Primary|Percentage of Patients With Progression-free Survival at 2 Years|"Progression-free survival (PFS): The length of time during and after the treatment that a patient lives with the disease but it does not get worse.~Progressive disease is specified by the NCI (National Cancer Institute) working group guidelines and additional CT (computerized tomography) scan requirements:~Lymphadenopathy, > 50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations; one lymph node must be at least 2 cm.~An increase in the liver or spleen size by 50% or more by CT scan or the de novo appearance of hepatomegaly or splenomegaly.~An increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter.~Transformation to a more aggressive histology or occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL."|2 years||||percentage of participants||95% Confidence Interval|Number
1442217|NCT00918723|Primary|Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I)|"The MTD of vorinostat in combination with FCR will be defined as the dose level immediately below the dose level at which greater than or equal to 2 patients out of 6 of a cohort experience dose-limiting toxicity. Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Doses of vorinostat analyzed to reach the MTD were 200 mg, 300 mg and 400 mg."|28 days||||mg|||Number
1442218|NCT00918684|Primary|Stroop Color-Word Test|A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.|14 weeks (12th week of treatment)||||units on a scale||Standard Deviation|Mean
1442986|NCT00912002|Secondary|Number of Participants Who Experienced An Adverse Event||Up to 14 days after study drug administration|All treated participants.|||participants|||Number
1442219|NCT00918684|Primary|WHODAS-II Disability Scale|A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.|14 weeks (12th week of treatment)||||units on a scale||Standard Deviation|Mean
1442220|NCT00918684|Primary|Hamilton Depression Rating Scale.|A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|14 weeks (12th week of treatment)||||units on a scale||Standard Deviation|Mean
1442221|NCT00918671|Secondary|Change of Medication Days/Month Compared to Baseline||Baseline and after 4 years' of follow-up||||medication days/month||Standard Deviation|Mean
1442222|NCT00918671|Primary|Change in Headache Days/Month After 4 Years Compared to Baseline|Change in headache days/month after 4 years compared to baseline|Baseline and after 4 years||||headache days/month||Standard Deviation|Mean
1442223|NCT00918645|Secondary|Number of Patients With Correlation Between 41Ca Clearance and Disease Stage|Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.|Samples will be collected over 18 months|Due to small population size Data were not collected||||||
1442224|NCT00918645|Secondary|Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression|Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir.|Samples will be collected over 18 months|Due to small population size of both Urinary samples and disease progression, no correlation data was collected||||||
1442225|NCT00918645|Primary|Number of Patients Whose Samples Were Measured for Pharmacokinetics|Pre-dose specimens will be provided immediately prior to dose administration. Day 1 specimens shall be collected by the subjects 6 hours after dosing (at home); all subsequent urine specimens may be collected at any time during the day and blood specimens should be taken at the same time of day, if feasible (e.g., morning fasted).|Samples will be collected over 18 months|No data was collected from the specimens.||||||
1442226|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2|Specific systemic events (fever >=38 degrees C, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and use of antipyretic medications) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours); Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 2 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.|||percentage of participants|||Number
1442227|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1|Specific systemic events (fever >=38 degrees Celsius[C], vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, use of antipyretic medications) were prompted for each day and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any(symptom present); Mild(did not interfere with activity); Moderate(some interference); Severe(prevented routine daily activity). Vomiting was scaled as: Any(vomiting present); Mild(1-2 times in 24 hours); Moderate(>2 times in 24 hours); Severe(required intravenous hydration). Diarrhea was scaled as: Any(diarrhea present); Mild(2-3 loose stools in 24 hours);Moderate(4-5 loose stools 24 hours); Severe(>=6 loose stools in 24 hours). Here number of participants analyzed signifies the safety population for Dose 1 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified systemic event. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.|||percentage of participants|||Number
1442228|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (<2.5 cm for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged >=12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here number of participants analyzed signifies the safety population for Dose 2 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 2|Safety population for Dose 2 included all participants who received Dose 2 of study vaccine and had safety data available.|||percentage of participants|||Number
1442229|NCT00918580|Other Pre-specified|Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1|Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as: Any (redness present or swelling present); Mild (less than <2.5 centimeters [cm] for participants aged 6 to <12 years and 2.5 to 5.0 cm for participants aged greater than or equal to [>=] 12 years); Moderate (2.5 to 7.0 cm for participants aged 6 to <12 years and 5.1 to 10.0 cm for participants aged >=12 years); Severe (>7 cm for participants aged 6 to <12 years and >10 cm for participants aged >=12 years). Pain was scaled as: Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Here “Number of participants analyzed” signifies the safety population for Dose 1 and “N” signifies those participants who reported “Yes” for at least 1 day or “No” for all days for specified local reaction. Participants may be represented in more than 1 category.|Within 7 days after 13vPnC Dose 1|Safety population for Dose 1 included all participants who received Dose 1 of study vaccine and had safety data available.|||percentage of participants|||Number
1454783|NCT00814970|Secondary|Secondary Patency Rate|Defined as vessel patency resulting from any procedure that restores patency.|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
1442230|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||titer||95% Confidence Interval|Geometric Mean
1442231|NCT00918580|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)|"Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||titer||95% Confidence Interval|Geometric Mean
1442232|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and N signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category."|1 year after 13vPnC Dose 2|Evaluable immunogenicity population at 1-year follow-up: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||mcg/mL||95% Confidence Interval|Geometric Mean
1442233|NCT00918580|Secondary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody|"Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
1442234|NCT00918580|Secondary|Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 – Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||ratio of GMFR||95% Confidence Interval|Geometric Mean
1442245|NCT00918346|Primary|Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Intention To Treat (ITT): randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.|||mmHg||95% Confidence Interval|Mean
1442246|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 4|IOPs at week 4: mean IOP values at four timepoints (worse eye)|Week 4|IOPs of all subjects who received preserved/unpreserved formulation|||mmHg||Standard Deviation|Mean
1442247|NCT00918346|Primary|Intraocular Pressures (IOPs) at Week 1|IOPs at week 1: mean IOP values at four timepoints (worse eye)|Week 1|IOPs of all subjects who received preserved/unpreserved formulation|||mmHg||Standard Deviation|Mean
1443812|NCT00905567|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in statistical analysis.|||ng/mL||Standard Deviation|Mean
1442235|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||fold rise||95% Confidence Interval|Geometric Mean
1442236|NCT00918580|Secondary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and N signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category."|Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||fold rise||95% Confidence Interval|Geometric Mean
1442237|NCT00918580|Primary|Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and “N” signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.|1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2|Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).|||fold rise||95% Confidence Interval|Geometric Mean
1442238|NCT00918463|Secondary|To Determine Potential Correlatives of Response.||2 years|Data was not collected due to early termination of the study.||||||
1442239|NCT00918463|Secondary|To Evaluate the Safety of Dasatinib Monotherapy as Treatment for Subjects With Relapsed or Refractory Aggressive DLBCL.||2 years|Data was not collected due to early termination of the study.||||||
1442240|NCT00918463|Primary|Response Rate|Response rate will be used as a measure of efficacy of dasatinib monotherapy in relapsed or refractory aggressive Diffuse Large B-Cell Lymphoma (DLBCL)|2 years|Data was not collected due to early termination of the study.||||||
1442241|NCT00918385|Secondary|Overall Response Rate of Men With Low AR Activity|Tumor response is based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During dasatinib monotherapy ( at least 12 weeks)|Of the 17 subjects treated, 15 had response documentation and are included in the calculation. Two were omitted (1 because response documentation was not provided; 1 ended treatment after 2 weeks for toxicity prior to repeat scans).|||percentage of patients with CR,PR||95% Confidence Interval|Number
1442242|NCT00918385|Secondary|Overall Response Rate of Men With High AR Activity|Tumor response was based on Response Criteria in Solid Tumors (RECIST). Complete response (CR) is defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|During monotherapy (at least 12 weeks)|14 subjects began treatment; 13 with response documentation are included in the calculation; 1 subject was omitted because response documentation was not provided.|||percentage of patients with CR,PR||95% Confidence Interval|Number
1442243|NCT00918385|Primary|Progression Free Survival (PFS)|PFS is the interval from start of monotherapy until first disease progression or death, whichever occurred first.|During monotherapy ( at least 12 weeks)||||months||90% Confidence Interval|Median
1442244|NCT00918346|Primary|Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)|Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.|Baseline - Week 4|Per Protocol (PP): randomized patients who completed the study per protocol (i.e. excluded from PP is the discontinued patient and a patient with major protocol violation)|||mmHg||95% Confidence Interval|Mean
1442269|NCT00918203|Secondary|PK - Steady State Volume of Distribution (Vss) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
1442248|NCT00918346|Secondary|Change From Baseline in Time-wise IOPs at Week 4|The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 4|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.|||mmHg||95% Confidence Interval|Mean
1442249|NCT00918346|Secondary|Overall and Time-wise Comparisons of IOP at Week 1|The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.|Baseline - Week 1|ITT: randomized patients who received at least one dose of study medication and had at least one pharmacodynamic (IOP) measurement available.|||mmHg||95% Confidence Interval|Mean
1442250|NCT00918346|Primary|Intraocular Pressures (IOPs) at Baseline|IOPs at baseline: mean IOP values at four timepoints (worse eye)|Baseline|IOPs of all subjects who received preserved/unpreserved formulation|||mmHg||Standard Deviation|Mean
1442251|NCT00918333|Other Pre-specified|Changes in Biological Markers|Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher’s exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.|Baseline to up to 12 courses|||||||
1442252|NCT00918333|Other Pre-specified|Change in Pharmacologic (Pharmacokinetic/Pharmacodynamic) Parameters|Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher’s exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.|Day 5 and 19 of the first course and then day 1 of each subsequent courses (courses 2-4) prior to the daily dose and 1 and 2 hours after each dose|||||||
1442253|NCT00918333|Secondary|Duration of Response (Phase II)|Duration of response is defined as the time from the date at which the objective status is first noted to be (for myeloma) a complete response (CR, defined as Negative immunofixation(IFE) of the serum and urine, < 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) or minor response(MR, defined as ≥25% but < 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%); (for lymphoma) a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Estimated using the method of Kaplan-Meier.|The time from the date at which the patient’s objective status is first noted to be a CR, sCR, VGPR, PR, or minor response to the earliest date progression is documented, assessed up to 2 years post-treatment|Patients who were enrolled in and completed Phase II and objective status are first noted to be CR, sCR, VGPR, PR or MR were evaluable for this endpoint.|||months||95% Confidence Interval|Median
1442254|NCT00918333|Secondary|Progression-free Survival (Phase II)|Progression-free survival time is defined as the time from registration to progression or death due to any cause. Progression is defined for myeloma as Any one or more of the following: Increase of 25% from lowest value in, Serum M-component (absolute increase must be ≥ 0.5 g/dl), Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl,Urine M-component (absolute increase must be ≥ 200 mg/24 h), Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder: Development of new soft tissue plasmacytomas or bone lesions, Hypercalcemia (≥11.5 mg/dl) Decrease in hemoglobin of ≥2 g/dl, Serum creatinine level ≥2 mg/dl. Progression is defined for lymphoma as any new lesion or increase by ≥50% of previously involved sites from nadir. The median and 95% confidence intervals are estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 2 years post-treatment|Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.|||months||95% Confidence Interval|Median
1442255|NCT00918333|Secondary|Overall Survival Time (Phase II)|Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 2 years post-treatment|Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.|||months||95% Confidence Interval|Median
1442256|NCT00918333|Primary|Overall Response Rate (Phase II)|For myeloma, a complete response(CR, defined as Negative immunofixation(IFE) of the serum and urine, < 5% plasma cells in bone marrow(BM), Disappearance of plasmacytomas), stringent CR(sCR, defined as CR plus Normal serum FLC ratio, Absence of clonal cells in BM), very good partial response(VGPR, defined as PR plus Serum and urine M-component detectable by IFE but not on electrophoresis), partial response(PR, defined as a ≥ 50% reduction of serum M-protein and/or reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h), or minor response(MR, defined as ≥25% but < 49% reduction of serum M-protein and reduction in 24h urine M-protein by 50-89%) noted as the objective status. For lymphoma, a CR(defined as no evidence of measurable disease), or PR(defined as regression of measurable disease and no new sites of disease) noted as the objective status. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.|Up to 12 courses|Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.|||percentage of patients||95% Confidence Interval|Number
1442270|NCT00918203|Secondary|PK - Clearance (Cl) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hr, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose.|||Liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1442257|NCT00918333|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.|4 weeks|The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).|||Participants|||Count of Participants
1442258|NCT00918281|Secondary|The Safety of Greater Than or Equal to 2 Administrations, Each of a Maximum of 370MBq, Fluciclatide Injection (AH111585 (18F) Injection) in Subjects With Solid Primary or Metastatic Tumors.|Safety was monitored throughout the duration of the subject’s participation.|Up to 8 weeks post contrast administration.|The variable is looking at the Overall Summary of Treatment-Emergent Adverse Events (TEAE). Subjects could have experienced more than one TEAE. The category titles refer to Severe Adverse Events(SAE) and Adverse Events (AE).|||number of adverse events|||Number
1442259|NCT00918281|Primary|Test Image and Retest Image Reproducibility of Fluciclatide Injection ([18F]AH111585) Uptake by Solid Tumors Following Intravenous Administration of AH111585 (18F) Injection Via PET Imaging.|Mean relative differences of Standardized uptake value (SUV) following intravenous administration of AH111585 (F18) Injection between the two PET imaging sessions.|Forty minutes, 65 minutes and 90 minutes post Fluciclatide administration.|Subjects received 2 doses of Fluciclatide Injection (AH111585 (18F) Injection).|||Standardized Uptake Value||Standard Deviation|Mean
1442260|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 52|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 52|||||||
1442261|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 52|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 52|||||||
1442262|NCT00918255|Secondary|Change From Baseline in Modified Sartorius Scale at Week 16|The Modified Sartorius Scale reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|Baseline, Week 16|Population was Intent-to-treat (ITT). Imputation method was Last Observation Carried Forward (LOCF).|||scores on a scale||Inter-Quartile Range|Median
1442263|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 12|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 12|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
1442264|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 8|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
1442265|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 4|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 4|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
1442266|NCT00918255|Secondary|Percentage of Participants Achieving Clinical Response at Week 2|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 2|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
1442267|NCT00918255|Secondary|Percent Change From Baseline in Number of All Inflammatory Nodules and Plaques at Week 16|Includes inflammatory nodules that are tender, erythematous, and have diameters less than 5 cm and includes plaques that have diameters greater than or equal to 5 cm. Range for percent change is negative infinity to infinity. Negative percent changes from Baseline indicate improvement.|Baseline, Week 16|Population was Intent-to-treat (ITT) and included participants with any inflammatory nodules (defined as tender, erythematous) or plaques at Baseline. Imputation method was Last Observation Carried Forward (LOCF).|||percent change||Standard Error|Least Squares Mean
1442268|NCT00918255|Primary|Percentage of Participants Achieving Clinical Response at Week 16|Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).|Baseline, Week 16|Intent-to-treat analysis with non-responder imputation (participants with missing PGA scores counted as non-responders).|||percentage of participants|||Number
1442310|NCT00917384|Secondary|Maximum Concentration (Cmax) of IMC-1121B|Cmax was not analyzed as only pre-dose samples were collected.|6 weeks post-randomization|Zero participants were analyzed.||||||
1442271|NCT00918203|Secondary|PK - Half-Life (t1/2) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.|||days||Full Range|Geometric Mean
1442272|NCT00918203|Secondary|PK - Maximum Concentration (Cmax) of Olaratumab||Cycle 3, Day 1: Predose, 30 min, 1.5 hrs, 24,48,96,168 Hrs Post Dose|"All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3 first dose. PK data was not analyzed in the paclitaxel~+ carboplatin arm or the crossover to olaratumab arm."|||micrograms/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
1442273|NCT00918203|Secondary|Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab|AUC(0-168) = area under the concentration versus time curve from time zero to 168 hours post dose.|Cycle 3, Day 1: Predose, 30 minutes (min), 1.5 hours (hrs), 24,48,96,168 Hrs Post Dose|All randomized participants who received any dose of study drug and had evaluable PK data in Cycle 3. PK data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.|||microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1442274|NCT00918203|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline to Study Completion (Up to 8 Months)|All randomized participants who had baseline and post baseline Anti-Olaratumab antibodies. Those participants who did not meet eligibility criteria were not included in this assessment.|||percentage of participants|||Number
1442275|NCT00918203|Secondary|Pharmacodynamics of Olaratumab|Pharmacodynamics of Olaratumab was determined by analysis of pharmacodynamic markers vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF).|Cycle 1: Days 1, 8, and 15 pre- and post-infusion of Olaratumab; Cycles 2-6: day 1 only, pre- and post-infusion of Olaratumab|No data was available due to the collection of plasma samples was not fit for the assessment of PDGFs, as the collection procedure did not prevent platelet activation resulting in elevated levels of PDGFs in the circulation. Pharmacodynamics data was not analyzed in the paclitaxel + carboplatin arm or the crossover to olaratumab arm.||||||
1442276|NCT00918203|Secondary|Median Duration of Response|The duration of overall response is measured from the time measurement criteria are first met for Complete Response (CR)/Partial Response (PR) (whichever is first recorded) until the first date that the criteria for PD are met (taking as a reference for PD the smallest measurement recorded since the treatment started), initiation of other/additional antitumor therapy is first reported, or death, is objectively documented.|First Criteria Met for CR or PR to Measured PD Start of Other Antitumor Therapy or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug and had achieved tumor response of CR or PR. Median Duration of Response data was not analyzed in the crossover olaratumab arm.|||weeks||95% Confidence Interval|Median
1442277|NCT00918203|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Baseline to Measured PD or Study Discontinuation (Up to 31 Months)|All randomized participants who received any dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1442278|NCT00918203|Secondary|Overall Survival (OS)|Overall survival is defined as the time from date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS was censored on the last date the participants is known to be alive.|Baseline to Death From Any Cause (Up to 31 Months)|"All randomized participants who received any dose of study drug. OS data was not analyzed in the crossover olaratumab arm. Participants censored:~olaratumab + paclitaxel + carboplatin = 19 and paclitaxel + carboplatin = 20."|||weeks||95% Confidence Interval|Median
1442279|NCT00918203|Secondary|Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events||Up to 43 Months|All randomized participants who received any dose of study drug.|||participants|||Number
1442280|NCT00918203|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline to Study Completion (Up to 43 Months)|All randomized participants who received any dose of study drug.|||participants|||Number
1442281|NCT00918203|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression by RECIST version 1.1, or death from any cause. Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of their last tumor assessment. If there was no radiologic assessment at baseline or post baseline, participants were censored at the date of randomization. If death or progressive disease (PD) occurred after 2 or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.|Baseline to Measured PD or Death From Any Cause (Up to 31 Months)|All randomized participants who received any dose of study drug. Participants censored: paclitaxel + carboplatin = 13, olaratumab + paclitaxel + carboplatin = 20, and crossover to olaratumab = 4.|||weeks||95% Confidence Interval|Median
1442322|NCT00917267|Secondary|Change in Total Cholesterol (TC) From Baseline to Week 26|Change in TC from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
1442282|NCT00918138|Other Pre-specified|Participants With Reported Hypoglycemic Adverse Events During Treatment Period|Hypoglycemic events are based upon the Saxagliptin Predefined List of Events, which includes hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness. The Hypoglycemic events occurred in less than 5% of the participants and hence do not appear in the adverse events module.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.||||participants|||Number
1442283|NCT00918138|Other Pre-specified|Participants With Confirmed Hypoglycemia Events During the Treatment Period|'Confirmed' = recorded on the hypoglycemia AE case report form with a fingerstick for glucose <= 50 mg/dL and associated symptoms.|AEs: up to last treatment day (LTD) +1 day or last visit day (LVD), whichever came last ; SAEs: up to LTD +30 days or LVD + 30 days, whichever came last. Mean duration of exposure=27.7 days for Saxa 5 mg + Met XR 1500 mg, and 28.3 days for Met 2000 mg.|Treated participants|||participants|||Number
1442284|NCT00918138|Secondary|Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal|FPG measurements were done at baseline, day 14 and 28. At baseline and day 28, the FPG value=plasma glucose value collected 30 minutes prior to the morning meal during the domicile visit.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments. Last Observation Carried Forward (LOCF).|||mg/dL||Standard Error|Mean
1442285|NCT00918138|Secondary|Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)|Adjusted mean change from baseline in 2-hour postprandial (after mealtime) plasma glucose two hours after start of the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.|||mg/dL||Standard Error|Mean
1442286|NCT00918138|Primary|Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4|Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value.|Baseline, Week 4|Randomized participants who had both baseline and Week 4 assessments.|||mg/dL||Standard Error|Mean
1442287|NCT00918125|Other Pre-specified|Mean Knowledge Scores About ICD Therapy One Week Post Intervention.|We assessed knowledge of ICD therapy prior to the educational intervention, directly after the educational intervention and one week later. The tool used was a 13 question tool on key aspects of ICDs, risks and benefits, and health conditions eligible for an ICD. Scores could range from 0-13, with higher score indicating greater levels of knowledge.|one week post intervention|Mean scores were calculated with one point for each correct answer out of 13 questions for all patients with data.|||units on a scale||Standard Deviation|Mean
1442288|NCT00918125|Secondary|Receipt of an ICD|Patients were asked (or medical records reviewed) to determine if patients did receive an ICD within approximately 3 months post intervention.|3 months|All patients with data at 3 months|||participants|||Number
1442289|NCT00918125|Secondary|Decisional Conflict Scale|At one week post-intervention, patients were asked 9 questions from a modified decisional conflict scale to assess overall decisional conflict and three subscales (decision uncertainty; factors contributing to uncertainty; and perceived effective decision making). Overall scores range from 9 (no decisional conflict) to 45 (high decisional conflict).|one week post intervention|Patients with data at one week|||units on a scale||Standard Deviation|Mean
1442290|NCT00918125|Primary|Decision to Receive an ICD|At one week post-intervention, patients were asked what treatment option they preferred: ICD placement with medications; No ICD, continue with medications only; or unsure.|1 week post intervention|All patients with available data at one week|||Participants|||Number
1442291|NCT00917865|Secondary|Mean SUVmax of Low Versus High Gleason Groups|To determine id radiotracer uptake correlates with gleason score|4 minutes,16 minutes,28 minutes and 40 minutes||||Mean SUV max||Standard Deviation|Mean
1442292|NCT00917865|Primary|Diagnostic Performance Per Sextant at Each Time Point by Visual Analysis|"Each of 12 sextants per prostate (for a total of 120 sextants for the 10 patients) were analyzed separately at 4, 16, 28 and 40 min post-injection for the presence or absence of focal activity suspicious for tumor.~Sensitivity: Proportion of people with a disease who have a positive test result~Specificity: The proportion of people without disease who have a negative test result Positive Predictive Value (PPV):The probability that a person who has a positive test result has the disease for which the test was conducted.~Negative Predictive Value (NPV): The probability that a person who has a negative test result does not have the disease for which the test was conducted~Accuracy: Ability of the test to differentiate between disease and non-disease.~Note: 'n=' is the denominator used to compute each parameter."|At 4, 16, 28 and 40 minutes post-injection of FACBC|The number of participants for analysis was based on the protocol.Each prostate was divided into 12 sextants and then each sextant was visualized for abnormal focal uptake.The SUVmax for the malignant sextants were compared to that of the benign sextants. Note: 'n=' is the denominator used to compute each parameter.|||Percentage of Sextants|Participants|95% Confidence Interval|Number
1442293|NCT00917852|Primary|Major Device Events|Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.|1 month post-treatment||||Participants|||Count of Participants
1442294|NCT00917852|Primary|All Cause Mortality||30 days post-treatment|All enrolled subjects|||participants|||Number
1442295|NCT00917735|Primary|Circulating Concentrations of IGF Axis Proteins Including IGF-1 and IGFBP-3|Circulating levels of IGF-1 and IGFBP-3 were measured in fasting blood samples by ELISA method.|Baseline and month 12|Circulating concentrations of IGF axis proteins including insulin-like growth factor (IGF-1) and IGF binding protein 3 (IGFBP-3) at baseline and month 12|||ng/ml||95% Confidence Interval|Geometric Mean
1442559|NCT00915551|Secondary|Partial Clearance of Actinic Keratoses (AK)|Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population|||participants|||Number
1442296|NCT00917735|Primary|Circulating Concentrations of Reproductive Hormones Including Estrone, Estradiol, Androstenedione, Testosterone, and Sex Hormone Binding Globulin (SHBG)|Circulating levels of reproductive hormones including estrone, estradiol, androstenedione, testosterone and SHBG were measured in fasting blood samples by liquid chromatography/tandem mass spectrometry method.|Baseline and month 12|Circulating concentrations of reproductive hormones including estrone, estradiol, androstenedione, testosterone, sex hormone binding globulin (SHBG) at baseline and month 12|||pg/ml||95% Confidence Interval|Geometric Mean
1442297|NCT00917735|Primary|Mammographic Density|Percent mammographic density was measured on digital images using a computer-assisted and quantitative method.|Baseline and month 12|Mammographic density at baseline and month 12|||Percent||95% Confidence Interval|Geometric Mean
1442298|NCT00917644|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours; ln 2/kel, where kel is the termination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||hours||Standard Deviation|Mean
1442299|NCT00917644|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL); collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||ng/mL||Standard Deviation|Mean
1442300|NCT00917644|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast). PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||ng*hr/mL||Standard Deviation|Mean
1442301|NCT00917644|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax). Observed directly from data as time of first occurrence; PK parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population|||hours||Full Range|Median
1442302|NCT00917644|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng*hr/mL). Pharmacokinetic (PK) parameters derived from subject's concentration data; collected Period 1, Day 1 to Day 4; Period 2, Day 1 to Day 4.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population defined as all subjects randomized and treated who had > = 1 of the parameters of primary interest in > = 1 treatment period.|||ng*hr/mL||Standard Deviation|Mean
1442303|NCT00917579|Secondary|Plasma Elimination Half-life (t1/2)|t1/2 = terminal elimination half-life in hours.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||hours||Standard Deviation|Mean
1442304|NCT00917579|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax = time (hours) to maximum plasma concentration (Cmax).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||hours||Inter-Quartile Range|Median
1442305|NCT00917579|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax = maximum observed plasma concentration. Measured in nanograms per milliter (ng/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||ng/mL||Standard Deviation|Mean
1442306|NCT00917579|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|AUClast = area under the plasma concentration-time curve from 0 (predose) to the time of the last measureable concentration (Clast); measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|PK parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, with the exception of 1 time point.|||ng•hr/mL||Standard Deviation|Mean
1442307|NCT00917579|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)|AUCinf = Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time; measured in nanograms times hour per milliliter (ng•hr/mL).|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose|Pharmacokinetic (PK) parameter analysis population: all subjects enrolled and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Only 73 subjects contributed to the PK analysis in the reference group as plasma concentrations for 1 subject were below the limit of quantification, except 1 time point.|||ng•hr/mL||Standard Deviation|Mean
1442308|NCT00917501|Primary|Change From Baseline in Depression Symptom Severity at 12 Weeks|Change in Children’s Depression Rating Scale-revised (CDRS-R) Total Score from Baseline to 12 weeks CDRS-R score ranges from 17 (i.e., not depressed) to 113 (i.e., severe depression)|Baseline and 12 weeks||||Total score on CDRS-R||Standard Deviation|Mean
1442309|NCT00917384|Secondary|Number of Participants Who Developed Antibodies Against IMC-1121B|The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.|Baseline, 12 Weeks|Subset of the Safety Population: All randomized participants who received at least 1 dose of study drug and who had immunogenicity analysis performed.|||participants|||Number
1442311|NCT00917384|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.|Randomization up to 18 months|Safety Population: All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1442312|NCT00917384|Secondary|Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)|EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.|Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])|All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.|||units on a scale||Standard Error|Least Squares Mean
1442313|NCT00917384|Secondary|Duration of Response (DOR)|DOR is the interval from date of initial documented response (complete response [CR] or partial response [PR]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.|Randomization up to 17 months post-randomization|Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.||||||
1442314|NCT00917384|Secondary|Percentage of Participants With Objective Response (Objective Response Rate [ORR])|ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.|Randomization up to 17 months post-randomization|Intent-to-treat population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1442315|NCT00917384|Secondary|Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)|The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.|Week 12 post-randomization|Intent-to-treat population: all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1442316|NCT00917384|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).|Randomization up to 17 months|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.|||months||95% Confidence Interval|Median
1442317|NCT00917384|Primary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive|Randomization up to 28 months post-randomization|Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.|||months||95% Confidence Interval|Median
1442318|NCT00917267|Secondary|Assessment of Event Rate of Treatment-emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.|Baseline to Week 26|ITT Population.|||events per subject-year||Standard Error|Mean
1442319|NCT00917267|Secondary|Change in Blood Pressure From Baseline to Week 26|Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was not imputed.|||mmHg||Standard Deviation|Mean
1442320|NCT00917267|Secondary|Ratio of Triglycerides (TG) at Week 26 to Baseline|Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||ratio||Standard Error|Least Squares Mean
1442321|NCT00917267|Secondary|Change in High-Density Lipoprotein (HDL) From Baseline to Week 26|Change in HDL from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
1442323|NCT00917267|Secondary|Change in Body Weight (BW) From Baseline to Week 26|Change in BW from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||kg||Standard Error|Least Squares Mean
1442324|NCT00917267|Secondary|Change in Fasting Serum Glucose (FSG) From Baseline to Week 26|Change in FSG from baseline to Week 26.|Baseline, Week 26|ITT Population. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mg/dL||Standard Error|Least Squares Mean
1442325|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26|Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using LOCF approach.|||percentage of patients|||Number
1442326|NCT00917267|Secondary|Percentage of Patients Achieving HbA1c Targets <=7% at Week 26|Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).|Baseline, Week 26|ITT Population. Only patients with baseline HbA1c > target were included in calculation. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Missing data at endpoint was imputed using last observation carried forward (LOCF) approach.|||percentage of patients|||Number
1442327|NCT00917267|Primary|Change in HbA1c From Baseline to Week 26.|Change in HbA1c from baseline to Week 26.|Baseline, Week 26|ITT Population: Randomized patients received at least one dose of study drug. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1442328|NCT00917124|Secondary|Evidence of Coma, Stupor, Cerebral Insult, Delirium, Ventilation Longer Than 24 Hours, Myocardial Infarction, Atrial Fibrillation, Dialysis, Reoperation for Bleeding, Infection, Hospital Stay > 7 Days||7 postoperative days||||participants|||Number
1442329|NCT00917124|Primary|Difference in Incidence of Cognitive Impairment Between Groups. Change Between Preoperative and Postoperative Cognitive Function Was Assessed by Performing Standardized Neurocognitive Tests.|"The Mini-Mental State Examination (MMSE) total score is calculated by summing the item scores across several aspects of cognition. The maximum possible total score is 30 points.~Color Trials Test (CTT) measures sustained visual attention, visual scanning and graphomotor skills. The examiner records the length of time (in seconds) required by the patient to rapidly draw a line connecting the circles numbered 1 through 25 in consecutive order.~Grooved-Pegboard test (GP test) is manipulative dexterity test that contains twenty-five holes with randomly positioned slots and pegs which have a key along one side. Pegs must be rotated to match the hole before they can be inserted. The examiner records the time in seconds.~Cognitive impairment was defined as a decline in postoperative performance in one or more tests: decrease of MMSE score three points or more from baseline and decrease of one standard deviation or more in performance on CTT 1 and GP tests"|preoperative, 7 days postoperative|"3 participants in Control group did not perform control cognitive test- transferred to another hospital.~6 participants in INVOS group did not perform control cognitive test - transferred to another hospital n=4, declined to participate n=2"|||participants|||Number
1442330|NCT00916929|Secondary|Sensitivity|Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).|6-months|All patients enrolled in the study were included in this analysis with a total of 82 patients in each group. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D during data collection period. These 2 patients were censored from ICD cohort and included in CRT-D cohort at the time of upgrade based on as-treated analysis principle.|||percentage of true positives||95% Confidence Interval|Number
1442331|NCT00916929|Primary|False Positive Rate|False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.|6-months|All patients participating in the study were included in the analysis with a total of 82 patients in each arm. Of the 82 patients implanted with ICD, 2 were upgraded to CRT-D. These 2 patients were censored from the ICD cohort and included in the CRT-D cohort at the time of upgrade based on as-treated analysis principle resulting.|||departures from device threshold||95% Confidence Interval|Number
1442332|NCT00916721|Primary|Change in the Corrugator Muscle (EMG) Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Corrugator EMG will be obtained through Ag/AgCl electrodes. The amplified EMG signal will be integrated using a 300-msec. time constant. A Coulbourn Modular Instrument System was used to measure corrugator EMG during 4 periods; baseline, reading, imagery and recovery|Corrugator EMG level was measured at visit 3, after presentation of two neutral and two smoking scripts||||µV||Standard Deviation|Mean
1442333|NCT00916721|Primary|Change in Heart Rate (Beats Per Minute), Caused by Smoking Cues, Measured Using Script Driven Imagery|Heart rate was measured through 9-mm (sensor diameter) Ag/AgCl electrodes filled with electrolytic paste and placed on the medial surface of each forearm. Amplified electrocardiogram signal will input to a tachometer that will provide a voltage output reflecting interbeat interval, which will be transformed to HR. A Coulbourn Modular Instrument System was used to measure HR during 4 periods; baseline, reading, imagery and recovery|Heart rate was measured at visit 3, after presentation of two neutral and two smoking scripts||||beats per minute||Standard Deviation|Mean
1442334|NCT00916721|Primary|Change in the Skin Conductance Level, Caused by Smoking Cues, Measured Using Script Driven Imagery|Skin conductance level was obtained through 9-mm (sensor diameter) Ag/AgCl electrodes filled with isotonic paste placed on the non-dominant hypothenar surface using a constant-voltage technique. A Coulbourn Modular Instrument System was used to measure SC during 4 periods; baseline, reading, imagery and recovery.|skin conductance was measured at visit 3, after presentation of two neutral and two smoking scripts||||µS||Standard Deviation|Mean
1442500|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||IU/dL||Standard Deviation|Mean
1442335|NCT00916721|Secondary|Change in Craving Level to Smoking Cues Caused by Smoking Cues, Measured Using Script Driven Imagery|"Craving level will be measured using a 8 point Visual Analogue Scale (VAS) of craving. Participants will be ask How much do you want a cigarette right now Participants will answer accordingly: 0=no desire at all; 7=unable to resist craving"|Craving level was measured at visit 3, after presentation of two neutral and two smoking scripts||||units on a scale||Standard Deviation|Mean
1442336|NCT00916643|Primary|Frequency and Severity of CHD Symptoms (Angina)|This is equatable to the incidence of Cardiovascular AEs.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.|||participants|||Number
1442337|NCT00916643|Primary|Serious Unexpected Adverse Events||Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.|||participants|||Number
1442338|NCT00916643|Primary|Occurrence of Cardiovascular Events and Interventions|Adverse Events reported for Cardiovascular disease not directly related to therapy.|Participants were followed for one (1) year following discontinuation of treatment.|The number of participants for analysis was determined per protocol.|||participants|||Number
1442339|NCT00916643|Primary|Occurence of Death|The Categories listed in the table are the Adverse Events (or similar) that resulted in death.|Participants were followed for one (1) year following discontinuation of treatment.|Inclusion was per protocol.|||participants|||Number
1442340|NCT00916617|Secondary|Pharmacokinetic Parameters Including Maximal Serum Drug Concentration, Time to Maximal Serum Drug Concentration, and Terminal Half-life of Elimination||36 months|Because this study was terminated early, the planned pharmacokinetic analyses were not performed.||||||
1442341|NCT00916617|Primary|Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings|A brain Magnetic Resonance Imaging (MRI) was obtained from all participants at Week 13 and quarterly thereafter. Participants were to meet the following criteria: screening brain MRI scan is consistent with the diagnosis of Alzheimer's Disease. Screening diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Clinically significant MRIs were identified by the investigator. The number of participants with clinically significant MRIs are tabulated by visit and treatment group.|Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit|The safety population included all participants who received at least 1 dose of study medication in Study NCT00916617.|||Participants|||Number
1442342|NCT00916578|Primary|Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.|The response by RECIST was assessed after 45 Gy of radiation for patients with breast cancer treated with concurrent capecitabine and radiation therapy.|Participants were monitored from 2009 to 2012.|All patients who received protocol - specified treatment.|||participants|||Number
1442343|NCT00916539|Secondary|Range of Motion: Radial Deviation|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
1442344|NCT00916539|Secondary|Range of Motion: Ulnar Deviation|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
1442345|NCT00916539|Secondary|Range of Motion: Extension|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
1442346|NCT00916539|Secondary|Range of Motion: Flexion|Range of motion measures the ability to move the wrist joint after injury.|6 months||||degrees||Standard Deviation|Mean
1442347|NCT00916539|Secondary|Visual Analog Scale for Pain|The pain scale measures the amount of pain on a scale from 0 to 10, where 10 indicates the most pain and 0 is no pain.|6 months||||units on a scale||Standard Deviation|Mean
1442348|NCT00916539|Secondary|Grip Strength||6 months||||kilograms||Standard Deviation|Mean
1442349|NCT00916539|Secondary|Modified Mayo Wrist Score|The Modified Mayo Wrist Score evaluates wrist function after treatment. The total score ranges from 0 to 100, with higher scores indicating a better result.|6 months||||units on a scale||Standard Deviation|Mean
1442350|NCT00916539|Secondary|DASH Questionnaire|This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability).|6 months||||units on a scale||Standard Deviation|Mean
1442351|NCT00916539|Primary|Extent of Union|The investigators looked at the extent of fracture union after immobilization.|10 weeks||||percentage of union||Standard Deviation|Mean
1442352|NCT00916383|Secondary|Safety, Tolerability, and Adhesion|See Adverse Event section for Safety assessment. Adhesion was assessed according to the following scoring criteria: Score 0 = approximately > 90% adhered (essentially no lift off the skin); Score 1 = approximately 75% to < 90% adhered (some edges only lifting off the skin); Score 2 = approximately 50% to < 75% adhered (less than half of the system lifting off the skin); Score of 3 = approximately < 50% adhered but not detached (more than half of the system lifting off the skin without falling off); Score of 4 = Patch-system detached (patch /overlay completely off the skin).|Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.|||||||
1442353|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||participants|||Number
1442366|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442354|NCT00916383|Primary|Skin Irritation (Other Skin Effects)|Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.|||participants|||Number
1442355|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||participants|||Number
1442356|NCT00916383|Primary|Skin Irritation (Papules and Vesicles)|Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on < 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on > 50% of skin site, with multiple (> 3) clusters.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.|||participants|||Number
1442357|NCT00916383|Primary|Skin Irritation (Edema)|Edema was used to determine skin irritation using a modified Draize scale. Score 0 = no edema; Score 1 = very slight edema; Score 2 = slight edema; Score 3 = moderate to severe edema; Score 4 = severe edema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||units on a scale||Standard Deviation|Mean
1442358|NCT00916383|Primary|Skin Irritation (Erythema)|Erythema was used to determine skin irritation using a modified Draize scale. Score 0 = no erythema; Score 1 = very slight erythema; Score 2 = well-defined erythema; Score 3 = moderate to severe erythema; Score 4 = severe erythema.|1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)|All patients who received patches are included in the analysis.|||units on a scale||Standard Deviation|Mean
1442359|NCT00916383|Primary|Skin Irritation (Erythema and Edema)|Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.|Immediately after patch removal|All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.|||units on a scale||Standard Deviation|Mean
1442360|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442361|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442362|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442363|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Overall (0-758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442364|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Overall (0-393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442365|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442382|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442367|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442368|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442369|NCT00916370|Secondary|Stent Thrombosis|Per ARC, definite and probable|Very Late (394 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442370|NCT00916370|Secondary|Stent Thrombosis|Per protocol|Late (31 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442371|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Late (31 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442372|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Acute/Subacute (0 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442373|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per ARC|Subacute (>1 - 30 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442374|NCT00916370|Secondary|Stent Thrombosis|Per protocol and per Academic Research Consortium (ARC, definite/probable)|Acute (≤1 day)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442375|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442376|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442377|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442378|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442379|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442380|NCT00916370|Secondary|All Death/All MI/All Coronary Revascularization|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442381|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442497|NCT00916136|Primary|Time to Pass Guidewire After Attaining Starting Point|Time to pass guidewire across reduced fracture once opening reamer is used in OR|while in Emergency Department (ED) up to 24 hours||||minutes||Standard Deviation|Mean
1442383|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442384|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442385|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442386|NCT00916370|Secondary|Cardiac Death/ All MI/CI-TLR||in-hospital|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442387|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442388|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442389|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442390|NCT00916370|Secondary|Cardiac Death/All MI|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442391|NCT00916370|Secondary|Cardiac Death/ All MI|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442392|NCT00916370|Secondary|Cardiac Death/All MI||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442393|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442394|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442395|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442396|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442397|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442398|NCT00916370|Secondary|All Coronary Revascularization (TVR and Non-TVR)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442399|NCT00916370|Secondary|All TVR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442400|NCT00916370|Secondary|All TVR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442401|NCT00916370|Secondary|All TVR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442402|NCT00916370|Secondary|All TVR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442403|NCT00916370|Secondary|All TVR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442404|NCT00916370|Secondary|All TVR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442405|NCT00916370|Secondary|All TLR (CI and Non-CI)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442406|NCT00916370|Secondary|All TLR (CI and Non-CI)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442407|NCT00916370|Secondary|All TLR (CI and Non-CI)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442408|NCT00916370|Secondary|All TLR (CI and Non-CI)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442409|NCT00916370|Secondary|All TLR (CI and Non-CI)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442410|NCT00916370|Secondary|All TLR (CI and Non-CI)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442411|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442412|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442413|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442414|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442415|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442416|NCT00916370|Secondary|Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442417|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442418|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442419|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442420|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442421|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442422|NCT00916370|Secondary|Clinically Indicated-Target Lesion Revascularization||In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442423|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442424|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442425|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442426|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442427|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442428|NCT00916370|Secondary|Non-target Vessel MI (Q-wave, Non Q-wave)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442429|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442430|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442431|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442432|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442433|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442434|NCT00916370|Secondary|Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)|Per Protocol|In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442435|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442436|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442437|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442438|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||180 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442439|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442440|NCT00916370|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)||In-hospital is less than or equal to 7 days post index procedure|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442441|NCT00916370|Secondary|Procedural Success (Subject Basis)|Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.|||percentage of participants|||Number
1442442|NCT00916370|Secondary|Device Success (Lesion Basis)|Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).|From the start of index procedure to end of index procedure|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.|||percentage of lesions|Participants||Number
1442443|NCT00916370|Secondary|Procedure Time|Procedure time is defined as time between insertion and withdrawal of guide catheter.|From insertion to withdrawal of guide catheter|The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.|||Minutes||Standard Deviation|Mean
1442444|NCT00916370|Primary|Target Lesion Failure (TLF)|"The composite rate of:~Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol."|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).|||percentage of participants|||Number
1442445|NCT00916357|Secondary|Time to Percentage of Insulin Exposure (as Measured by Area Under the Curve [AUC])|Time to percentage of exposure to insulin, as measured by area under the curve (AUC), following a liquid meal for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes following after injection of study drug|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to percentage of insulin exposure as measured by area under the curve (AUC) data.|||Minutes (min)||Standard Deviation|Mean
1442446|NCT00916357|Secondary|Percentage of Participants Without Hypoglycemia|Percentage of participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 who did not experience hypoglycemia following a liquid meal is reported. Hypoglycemia was defined as any blood glucose values lower than 70 milligrams per deciliter (mg/dL) or symptoms of hypoglycemia responding to treatment with glucose. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20.|||Percentage of participants|||Number
1442447|NCT00916357|Secondary|Minimum Postprandial Glucose (PPG)|Minimum postprandial glucose (PPG) in participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable minimum postprandial glucose (PPG) data.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1442448|NCT00916357|Secondary|Area Under the Time-Concentration Curve for Blood Glucose (AUC[BG])|Area under the time-concentration curve for blood glucose (AUC[BG]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), and Humulin-R + rHuPH20 following a liquid meal is reported. AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 160 milligrams per deciliter (mg/dL) or 140 mg/dL, or lower than 70 mg/dL within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the time-concentration curve for blood glucose (AUC[BG]) data.|||Milligrams per deciliter * minutes||Standard Deviation|Least Squares Mean
1442449|NCT00916357|Secondary|Area Under the Concentration Time-Curve for Serum Insulin From Time 0 to the End of Blood Sampling (AUC[Last])|Area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least squares mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable area under the concentration time-curve for serum insulin from time 0 to the end of blood sampling (AUC[last]) data.|||Minutes * picomoles /1000 (min*pm/1000)||Standard Deviation|Least Squares Mean
1442450|NCT00916357|Secondary|Mean Residence Time From Time 0 to the End of Blood Sampling (MRT[Last])|Mean residence time from time 0 to the end of blood sampling (MRT[last]) for participants who received Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable mean residence time from time 0 to the end of blood sampling (MRT[last]) data.|||Minutes (min)||Standard Deviation|Mean
1442451|NCT00916357|Secondary|Time to Late 50% Maximum Serum Insulin Concentration (Late[t50%])|Time to late 50% maximum serum insulin concentration (late[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to late 50% maximum serum insulin concentration (late[t50%]) data.|||Minutes (min)||Standard Deviation|Mean
1442498|NCT00916136|Primary|Difference in the Two Groups in Regards to Resident Time.|Time from consult entered to time traction apparatus is applied.|while in Emergency Department (ED) up to 24 hours||||minutes||95% Confidence Interval|Mean
1442452|NCT00916357|Secondary|Time to Early 50% Maximum Serum Insulin Concentration (Early[t50%])|Time to early 50% maximum serum insulin concentration (early[t50%]) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, and 120 minutes after injection of each study drug.|Predose up to 120 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to early 50% maximum serum insulin concentration (early[t50%]) data.|||Minutes (min)||Standard Deviation|Mean
1442453|NCT00916357|Secondary|Time To Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (Tmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable time to maximum serum insulin concentration (Tmax) data.|||Minutes (min)||Standard Deviation|Mean
1442454|NCT00916357|Secondary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) for participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 is reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug.|Predose up to 480 minutes after study drug injection|Participants who received at least one dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable maximum serum insulin concentration (Cmax) data.|||Picomoles per liter (pm/L)||Standard Deviation|Mean
1442455|NCT00916357|Primary|Postprandial Glucose (PPG) Excursion Following a Liquid Meal|Postprandial glucose (PPG) values in participants receiving Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 following a liquid meal are reported. Blood samples were collected at 30, 20, 10, and within 5 minutes before and at 3, 6, 9, 12, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 180, 210, 240, 300, 360, 420, and 480 minutes after injection of each study drug. Least square mean difference was calculated and tested using repeated measures analysis of variance with fixed effect for treatment.|Predose up to 480 minutes after study drug injection|Participants who received at least 1 dose of Humalog alone, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 with evaluable postprandial glucose (PPG) excursion data.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Least Squares Mean
1442456|NCT00916344|Secondary|Complication Free Rate|"Complication free rate (in %):~1 minus(the number of possibly pacemaker related complications divided by the number of patients)"|1- and 3- month follow-up completed||||Percentage complication free patients||95% Confidence Interval|Number
1442457|NCT00916344|Primary|Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)|"atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.~atrial threshold test: measurable automatically or manually."|1 month follow-up completed|At 1 month follow-up 93 patients with dual chamber pacemaker had both manual and automatic atrial treshold tests (ITT analysis).|||Volt|Participants|95% Confidence Interval|Mean
1442458|NCT00916305|Primary|Reduction in Dangerous Listening Behaviour Defined as Weekly Personal Noise Exposure in dB (LEPD)|Weekly average over the previous month|1 months||||Decibels per week||Standard Deviation|Mean
1442459|NCT00916305|Secondary|Reduction in Dangerous Listening Behaviour Defined as Daily Personal Noise Exposure in dB (LEPD) :to be Safe This Should Total Less Than 80dB|Daily average over the previous month|1 months||||Decibels per day||Standard Deviation|Mean
1442460|NCT00916279|Secondary|Binary Restenosis|Subjects with percent diameter stenosis >50% in the analysis segment.|6 Months|ITT|||participants|||Number
1442461|NCT00916279|Primary|Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months|Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.|6 Months|ITT|||percent diameter stenosis||Standard Deviation|Mean
1442462|NCT00916279|Secondary|MACE Rate|Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).|30 Days|ITT|||Percentage of patients|||Number
1442463|NCT00916279|Secondary|Late Lumen Loss|Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).|6 months|ITT|||(mm)||Standard Deviation|Mean
1442464|NCT00916279|Primary|Percent Diameter Stenosis (%DS) in the Analysis Segment||6 months|ITT|||Percentage stenosis of vessel diameter||Standard Deviation|Mean
1442465|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Adverse Events Profile (AEP)|Change in Adverse Events Profile score (scores range from 19-76; higher scores indicate greater side effects)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
1442466|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: NDDIE|Change in Neurological Disorders Depression Inventory for Epilepsy (NDDIE) score (scores range from 0-24; higher scores indicate greater depressive symptoms)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
1442467|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Reaction Time|Change in Facial Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442468|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Facial Recognition Accuracy|Change in Facial Recognition Accuracy Score (accuracy ranges from 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
1442469|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Reaction Time|Change in Verbal Recognition Reaction Time Score (indicates processing speed, with reaction time measured in seconds)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442470|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Recognition Accuracy|Change in Verbal Recognition Accuracy Score (accuracy ranges from 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
1442471|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Reaction Time|Change in Non-verbal Working Memory Reaction Time Score (indicates processing speed, with reaction time measured in seconds)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442472|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Non-verbal Working Memory Accuracy|Change in Non-verbal Working Memory Accuracy Score (accuracy ranges from 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
1442473|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Reaction Time|Change in Verbal Working Memory Reaction Time Score, with reaction time measured in seconds (indicates processing speed)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442474|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Working Memory Accuracy|Change in Verbal Working Memory Accuracy Score (range 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
1442475|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Reaction Time|Change in Choice Reaction Time Score, with reaction time measured in seconds (indicate if red or blue stimulus; lower reaction time suggests better performance)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442476|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Choice Accuracy|Change in Choice Accuracy Score (indicate if red or blue stimulus; accuracy 0-100%)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
1442477|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Reaction Time (CPT RT)|Change in Continuous Performance Test Score - Reaction Time, measured in seconds (CPT RT; less time reflects better performance)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442478|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CPT Accuracy|Change in Continuous Performance Test Score - Accuracy (CPT; score ranges from 0-100% correct)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||percentage of correct responses||Standard Deviation|Mean
1442479|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Symbol|Change in Digit Symbol Score (The score is the number of items completed. A higher score reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
1442480|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Grooved Pegboard|Change in Grooved Pegboard Score (The score is the time for completion. A lower score reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442481|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Trails Test|Change in Trails Test score (The score is the time for completion in seconds. A lower score reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442482|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Design Fluency|Change in Design Fluency score (Score range: lowest score = 0; there is no upper limit. A higher score reflects more designs generated, hence better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
1442499|NCT00916032|Secondary|Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||IU/dL||Standard Deviation|Mean
1442483|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Stroop|Change in Stroop score (The score is the time for completion in seconds; less time reflects better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||time (seconds)||Standard Deviation|Mean
1442484|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Verbal Fluency|Change in Verbal Fluency score (Score range: lowest score = 0, with no upper limit, reflecting total number of words generated. Higher scores indicate better performance.)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
1442485|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Digit Span|Change in Digit Span score (score ranges from 0-30; higher scores indicate better performance). Scores indicate the number of digit sequences correctly recalled, forwards and backwards.|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442486|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: Spatial Span|Change in Spatial Span score (score ranges from 0-32; higher scores indicate better performance). Scores indicate the number of spatial sequences correctly recalled, forwards and backwards.|1 and 11 Weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442487|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: LNS|Change in Letter-Number Sequencing score (LNS; score ranges from 0-21; higher scores indicate better performance). The score reflects the number of items that the subject can correctly recall and place in proper alphabetical and numerical sequence.|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||scores on a scale||Standard Deviation|Mean
1442488|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: QOLIE|Change in Quality of Life Inventory in Epilepsy-89 score (QOLIE; score ranges from 0-100; higher scores reflect better quality of life)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures. The QOLIE is specific to epilepsy and was only administered in that subject group.|||scores on a scale||Standard Deviation|Mean
1442489|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Delayed Recall|Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall score (the score ranges from 0-6, reflecting the number of shapes recalled after a 25 minute delay)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442490|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Total Learning|Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning score (the score is summed across 3 learning trials, score range 0-18, reflecting the total number of shapes recalled)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442491|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: BVMT-R Learning|Change in Brief Visuospatial Memory Test-Revised (BVMT-R) Learning score (the score ranges from 0-6, reflecting the number of shapes recalled on the initial learning trial)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442492|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Long Delay|Change in California Verbal Learning Test (CVLT) Long Delay Recall score (the score ranges from 0-16, reflecting the number of words recalled)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442493|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Short Delay|Change in California Verbal Learning Test (CVLT) Short Delay Recall Score (the score ranges from 0-16, reflecting the number of words recalled)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442494|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Total Learning|Change in California Verbal Learning Test (CVLT) Total Learning Score (the total learning score is summed across 5 learning trials, range 0-80). Higher scores indicate better memory. Scores on the CVLT reflect the number of words recalled.|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across outcome measures.|||number recalled||Standard Deviation|Mean
1442495|NCT00916149|Secondary|Performance on Neuropsychological Batteries and Computerized Cognitive Testing: CVLT Trial 1 Learning Score|Change in California Verbal Learning Test (CVLT) Trial 1 learning score (range 0-16; higher score indicates better memory)|1 and 11 weeks|Not all subjects completed each neuropsychological test (e.g., lack of time, fatigue, computer issues); hence, the number analyzed may differ across measures.|||scores on a scale||Standard Deviation|Mean
1442496|NCT00916149|Primary|Mean Change in Focal Interictal Discharges (IEDs) Per Hour, Pre to Post Treatment|This descriptive analysis examined the change in interictal discharge rates pre to post-treatment with levetiracetam in subjects with epilepsy and with no treatment in healthy controls.|1 and 11 weeks|In a preliminary analysis, data from 11 healthy controls and 6 subjects with partial-onset epilepsy were evaluated.|||IEDs/hour||Standard Deviation|Mean
1442501|NCT00916032|Secondary|Volume of Distribution at Steady State- One-stage aPTT Assay|computed as CL * MRT|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||dL/kg||Standard Deviation|Mean
1442502|NCT00916032|Secondary|Volume of Distribution at Steady State- Chromogenic Assay|computed as Clearance (CL) * Mean residence time (MRT)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||dL/kg||Standard Deviation|Mean
1442503|NCT00916032|Secondary|Mean Residence Time (MRT)- One-stage aPTT Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||hour||Standard Deviation|Mean
1442504|NCT00916032|Secondary|Mean Residence Time (MRT)- Chromogenic Assay|Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||hour||Standard Deviation|Mean
1442505|NCT00916032|Secondary|FVIII Clearance- One-stage aPTT Assay|Computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||mL/(kg·h)||Standard Deviation|Mean
1442506|NCT00916032|Secondary|FVIII Clearance- Chromogenic Assay|computed as the dose divided by total AUC|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||mL/(kg·h)||Standard Deviation|Mean
1442507|NCT00916032|Secondary|Elimination Phase Half-life- One-stage aPTT Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.||||hour||Standard Deviation|Mean
1442508|NCT00916032|Secondary|Elimination Phase Half-life- Chromogenic Assay|calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.||||hour||Standard Deviation|Mean
1442509|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- One-stage aPTT Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1442510|NCT00916032|Secondary|Incremental Recovery at 30 Minutes- Chromogenic Assay|Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion|30 minutes pre-infusion and 30 minutes post-infusion|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1442511|NCT00916032|Secondary|Incremental Recovery at Cmax - One-stage aPTT Assay|Determined as the highest FVIII activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1442512|NCT00916032|Secondary|Incremental Recovery at Cmax - Chromogenic Assay|Determined as the highest Factor VIII (FVIII) activity achieved post-infusion|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.|Intent to Treat|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1442513|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
1442514|NCT00916032|Secondary|Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay|The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
1442515|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
1442516|NCT00916032|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay|Computed using the linear trapezoidal method.|Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.|Intent to Treat|||(IU·h)/dL||Standard Deviation|Mean
1442517|NCT00916006|Secondary|Patients With Partial Clearance of Actinic Keratosis (AK)|Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area|baseline and 57 days|Intention to treat population|||participants|||Number
1442518|NCT00916006|Primary|Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.|Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population|||participants|||Number
1442519|NCT00915902|Primary|Change in Triglyceride Level||after 8 week treatment or placebo period||||mg/dL||Standard Deviation|Mean
1442520|NCT00915876|Primary|Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56|Values of ICAM-1 (intracellular adhesion molecule) a measure of vascular reactivity, at three time points: baseline, day 28, and day 56|Day 28 and Day 56||||nanogram/ml||Standard Deviation|Mean
1442558|NCT00915590|Primary|Incidence and Severity of Ocular Adverse Event|Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.|64 Weeks||||participants|||Number
1442521|NCT00915798|Secondary|Salivary Cotinine|Average level of salivary cotinine over all time points (microgram/milliliter)|Once per week for 4 weeks|Discrepancies between participants cotinine samples and participant flow are due to the fact that not all participants provided useful saliva samples.|||Microgram/milliliter||Standard Deviation|Mean
1442522|NCT00915798|Secondary|DRD4 Genotype||one time blood draw|Discrepancies between participant flow and data analyze reflect that not all participants provided blood samples. Dopamine genotypes were only available for participants who were also enrolled in the Multimodal Treatment for ADHD Study (MTA-Study).|||Participants|||Count of Participants
1442523|NCT00915798|Primary|Brain Activity|BOLD z-score of smokers with ADHD after abstinence/smoking a cigarette, control smokers after abstinence/smoking a cigarette, nonsmokers with ADHD, and control nonsmokers. All participants performed a mathematical task in the MRI scanner. Higher BOLD z-scores indicate greater brain activation.|One MRI session for nonsmokers and two MRI sessions for smokers|Discrepancies between participant flow and number of participants analyzed are due to motion artifacts, which compromised the MRI findings. Thus, a number of participants had to be excluded from the MRI data analysis.|||z-score||Standard Deviation|Mean
1442524|NCT00915772|Primary|Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE|Frequency of patients with adverse events by treatment, primary system organ class and preferred term|Baseline and drug stop (up to 54 weeks) + 7 days|Treated Set (TS)|||participants|||Number
1442525|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).|78 weeks|Non-switcher set (OC) with non-missing data at visit. Only patients who continued on the same treatment in both studies are included|||Percentage||Standard Deviation|Mean
1442526|NCT00915772|Secondary|Number of Patients With Rescue Therapy||54 weeks|TS|||Number of patients|||Number
1442527|NCT00915772|Secondary|Change in FPG From Baseline Over Time|Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit|||mg/dL||Standard Deviation|Mean
1442528|NCT00915772|Secondary|Number of Patients With HbA1c of at Least <0.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)|||participant|||Number
1442529|NCT00915772|Secondary|Number of Patients With HbA1c <6.5% Over Time||54 weeks|Treated Set with non completers considered as failures (NCF)|||participant|||Number
1442530|NCT00915772|Secondary|Number of Patients With HbA1c <7.0% After 54 Weeks||54 weeks|Treated Set with non completers considered as failures (NCF)|||participant|||Number
1442531|NCT00915772|Secondary|Change in HbA1c From Baseline Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.|54 weeks|TS (OC) with non-missing data at visit|||Percentage||Standard Deviation|Mean
1442532|NCT00915772|Primary|Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry|ULN means upper limit of normal|54 weeks|TS and observed cases (OC). In treatment group L2.5+M500, the number of patients analysed was 224 for lactate dehydrogenase abnormality and total bilirubin abnormality due to anailable data.|||participants|||Number
1442533|NCT00915772|Primary|Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology||54 weeks|TS and observed cases (OC)|||participants|||Number
1442534|NCT00915772|Primary|Change From Baseline at Week 54 in Pulse Rate|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)|||beats per minute (bpm)||Standard Deviation|Mean
1442535|NCT00915772|Primary|Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Baseline is defined as Visit 1 of 1218.52.|54 weeks|TS and observed cases (OC)|||mmHg||Standard Deviation|Mean
1442536|NCT00915772|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|54 weeks|Treated Set (TS): all screened patients who were documented to have taken at lease 1 dose of study drug.|||participant|||Number
1442537|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 3, ProKera and bandage contact lens were left in place until postoperative day 1.|||days to complete re-epithelialization|Participants|Standard Deviation|Mean
1442538|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK.For group 2, ProKera and bandage contact lens were left in place until postoperative day 3.|||days to complete re-epithelialization|Participants|Standard Deviation|Mean
1442539|NCT00915759|Secondary|Tear Protein Analysis||up to 1 month post-operatively||2013-12-31|12/2013||||
1442540|NCT00915759|Secondary|Corneal Clarity||one year postoperatively||2013-12-31|12/2013||||
1442541|NCT00915759|Secondary|Long-term Visual Outcomes||one year post-operatively||2013-12-31|12/2013||||
1442542|NCT00915759|Secondary|Visual Recovery||one year post-operatively||2013-12-31|12/2013||||
1442543|NCT00915759|Secondary|Complications/Adverse Events||one year post-operatively||2013-12-31|12/2013||||
1442544|NCT00915759|Secondary|Post-operative Pain|measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)|measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively||2013-12-31|12/2013||||
1442545|NCT00915759|Primary|Corneal Re-epithelialization|measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy|participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK. For group 1, ProKera and bandage contact lens were left in place until complete corneal re-repithelialization (healing).|||days to complete re-epithelialization|Participants|Standard Deviation|Mean
1442546|NCT00915655|Secondary|Virological Response [Viral Load <50 Copies/mL, FDA-SNAPSHOT]|The analysis is based on the last observed viral load (VL) data within the Week 24 window. Virologic response is defined as a VL<50 copies/mL (observed case). Virologic Failure includes a) patients who had >=50 copies/mL in the Week-24 window, b) patients who discontinued prior to Week 24 for lack or loss of efficacy, c) patients who had a switch in their background regimen that was not permitted by the protocol, and d) patients who discontinued for reasons other than adverse events (AEs)/death, and lack or loss of efficacy (provided their last available viral load was detectable).|Week 24|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1442547|NCT00915655|Primary|Virological Response[Viral Load <50 Copies/mL, TLOVR]|The analysis is based on virologic response defined as percentage of patients with confirmed plasma viral load <50 HIV-1 RNA copies/mL at Week 24 calculated according to the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) algorithm.|Week 24|The ITT analysis set was considered the primary efficacy analysis set.|||Participants|||Number
1442548|NCT00915603|Secondary|Overall Survival (OS)|Assessed from Day 1 of study drug administration to date of death due to any cause.|every 8 weeks until treatment discontinuation, expected average 6 months||||months||95% Confidence Interval|Median
1442549|NCT00915603|Secondary|Duration of Response (DOR)|Defined as time between date of objective response and date of response to disease progression or death, as defined by RECIST v1.1 criteria. Objective response is defined as either complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until treatment discontinuation, expected average 6 months||||months||95% Confidence Interval|Median
1442550|NCT00915603|Secondary|Overall Response Rate (ORR)|The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|every 8 weeks until treatment discontinuation, expected average of 18 months|Includes patients who were enrolled and randomized|||participants|||Number
1442551|NCT00915603|Secondary|Number of Patients With Treatment-related Adverse Events (AEs) as a Measure of Safety and Tolerability|Assessments will be made based on the analysis of reported incidence of treatment-emergent AEs|every 4 weeks until intolerable toxicity occurs|Includes patients who were enrolled, randomized and treated|||participants|||Number
1442552|NCT00915603|Primary|Progression-Free Survival (PFS)|Progression-free survival will be measured from Day 1 of study drug administration to disease progression defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months|Includes all enrolled and randomized patients|||months||95% Confidence Interval|Median
1442553|NCT00915590|Secondary|Central Corneal Thickness|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
1442554|NCT00915590|Secondary|Best Spectacle-Corrected Visual Acuity (BSCVA)|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
1442555|NCT00915590|Primary|Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
1442556|NCT00915590|Primary|Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 Weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
1442557|NCT00915590|Primary|Extent of Neovascular Area (NA)|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.|64 weeks|The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.||||||
1442561|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442562|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442563|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442564|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442565|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442566|NCT00915525|Secondary|Change From Study Baseline in Daily Frequency of Urgency Episodes|The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442567|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1443387|NCT00909610|Primary|Cmax for Baseline Corrected Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1442568|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442569|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442570|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442571|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442572|NCT00915525|Secondary|Change From Study Baseline in the KHQ Social Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442573|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442574|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442575|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442576|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442577|NCT00915525|Secondary|Change From Study Baseline in the KHQ Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442578|NCT00915525|Secondary|Change From Study Baseline in the King’s Health Questionnaire (KHQ) Role Limitations Domain|The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442579|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442580|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442581|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442582|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442583|NCT00915525|Secondary|Change From Study Baseline in the I-QOL Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442584|NCT00915525|Secondary|Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1442585|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442586|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442587|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442588|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442605|NCT00915473|Secondary|Mean Number of Days With Acute Medication Use|"Acute medication use meant the consumption of a drug to abort or terminate a headache."|4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||days per 4 weeks||Standard Deviation|Mean
1442606|NCT00915473|Secondary|Mean Number of Hours With Moderate or Severe Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||hours per 4 weeks||Standard Deviation|Mean
1442589|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442590|NCT00915525|Secondary|Change From Study Baseline in the Daily Average Number of Micturition Episodes|The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Number of Episodes||Standard Deviation|Mean
1442591|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
1442592|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
1442593|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
1442594|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
1442595|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point TBS|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
1442596|NCT00915525|Primary|Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)|The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.|Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Percentage of Patients|||Number
1442607|NCT00915473|Secondary|Mean Frequency of Days With a Migraine||4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||days per 4 weeks||Standard Deviation|Mean
1442597|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 6|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1442598|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1442599|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1442600|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1442601|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1442602|NCT00915525|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).|Study Baseline, Week 12 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1442603|NCT00915499|Secondary|Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)|Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response.|3 months||||units on a scale||Standard Deviation|Mean
1442604|NCT00915499|Primary|Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period|AHI refers to the number of apneas and hypopneas that occurred per hour of sleep|3 months||||AHI (events/hour)||Standard Deviation|Mean
1454784|NCT00814970|Secondary|Assisted Primary Patency|Defined as vessel patency resulting from a procedure performed in the treated segment.|12 months|Intention-to-Treat (ITT)|||percentage of participants|||Number
1442608|NCT00915473|Primary|Number of Subjects With at Least 50% Reduction in the Frequency of Days With Moderate or Severe Migraine in the 4 Week Post Injection Compared to the 4 Week Pre-injection Baseline Period|The baseline frequency will be the number of calendar days with moderate or severe migraine during the 4 week period prior to injection, and the follow-up frequency will be the number of calendar days with migraine during the 4 week period following injection.|4 weeks pre-injection baseline, 4 weeks post-injection|Because of missing data, 33 subjects in the active arm and 30 subjects in the placebo arm were analyzed.|||participants|||Number
1442609|NCT00915356|Secondary|Percentage of Patients, Discharged Within 6 h (QTcF ≤500 ms) After Start of Infusion|Percentage, with 95% confidence interval, of patients with QTcF≤500 ms six hours following start of study drug infusion|Six hours following start of study drug infusion||||Percent of participants||95% Confidence Interval|Number
1442610|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 31 Days - 3 Months|Subgroup analysis for patients with duration of current AF episode 31 days – 3 months. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion||||Participants|||Number
1442611|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 8 Days - 30 Days.|Subgroup analysis for patients with duration of current AF episode 8 days - 30 days. Number of patients converting from AF to SR.|Conversion from AF to SR within 90 minutes from start of infusion||||Participants|||Number
1442612|NCT00915356|Secondary|Conversion From AF to SR Within 90 Minutes From Start of Infusion in the Subgroup of Patients With Duration of Current AF Episode 10 Hours to 7 Days||Conversion from AF to SR within 90 minutes from start of infusion||||Participants|||Number
1442613|NCT00915356|Secondary|Maximal Observed Plasma Concentration of AZD1305|Plasma concentration of AZD1305|Up to 24 hours following start of study drug infusion||||mol/L||Full Range|Median
1442614|NCT00915356|Secondary|Study the Relationship Between Systemic Exposure and Response, With Special Regards to Conversion of AF to SR and the Effect on the QTcF Interval.||Since this study is no longer intended to be part of any marketing authorisation application, the analyses addressing this objective were not conducted.|||||||
1442615|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 13 to 18 Days Following Study Drug Infusion.|Number of patients in SR at day 13-18|During 13 to 18 days following study drug infusion||||Participants|||Number
1442616|NCT00915356|Secondary|Heart Rhythm. Number of Patients Remaining in SR up to 24 h Following Start of Study Drug Infusion||During 24 hours following start of study drug infusion||||Participants|||Number
1442617|NCT00915356|Secondary|Heart Rhythm. Number of Participants With Early Relapse Into AF.|Early relapse into AF within 5 minutes from obtaining the defined criterion for conversion to SR (i.e.1 minute in SR). Patients never converted are not included in the analysis.|Within 5 minutes following investigational product (IP) induced conversion, or direct current (DC) cardioversion, of AF to SR||||Participants|||Number
1442618|NCT00915356|Secondary|Wide QRS Tachycardias|Number of patients with wide QRS tachycardias, determined as significant arrhythmias by an Adjudication Committee (AC). The AC analysed and classified the occurrence of significant arrhythmias (other than AF or AFl) and pauses based on the 12-lead Holter reports. All pauses (≥3 sec) and all wide QRS complex tachycardias (≥3 beats, QRS ≥120 ms, and ≥120 bpm).|From start of study drug infusion until discharge from hospital on study day 2.||||Participants|||Number
1442619|NCT00915356|Primary|Conversion of Atrial Fibrillation (AF) and Maintenance of Sinus Rhytm (SR)|Conversion of AF to SR with maintenance of SR maintained for at least 1 minute|Within 90 minutes from start of infusion||||Percentage of patients converted to SR||95% Confidence Interval|Number
1442620|NCT00915356|Primary|Dose-response Relationship for QTcF Interval of AZD1305|QTcF-QT interval corrected for the RR interval (the time elapsing between two consecutive R waves in the electrocardiogram (ECG)) using the Fridericia formula.For each of 3 consecutive beats (5 consecutive beats if AF) a manual measurement, preferably in lead V2, of QTend intervals was done.The mean QT values of the 3 consecutive beats (5 consecutive beats if AF) were, together with RR intervals, date & time of the ECG, entered into the eCase Report Form (eCRF).The selected beats had to be marked with calipers and noted together with measured values and calculations on the print-out and signed|At any time post randomisation until end of Holter recording (18-24 hours post start of drug infusion).||||ms||95% Confidence Interval|Mean
1442621|NCT00915343|Secondary|Comparison on 24-hour Urinary Free Cortisol Between Once Daily and Thrice Daily Therapy-Part A||12 weeks|Part A Safety population consisted of all randomised patients who took at least one dose of study medication. Safety population with participants evaluable for this outcome.|||nanomoles per 24 hours||Standard Deviation|Mean
1442622|NCT00915343|Secondary|Comparison on Participant Preference by Questionnaire Between Once Daily and Thrice Daily Therapy-Part A|"Participant Preference Questionnaire consisted of the following set of questions:~1. How large was the benefit with OD compared to TID and the responses were recorded as considerably poorer, somewhat poorer, comparable, large, very large; 2. How strongly concur with the following statement: I prefer novel OD to conventional TID and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly; 3. How strongly concur with the following statement: I prefer conventional TID to novel OD and the responses were recorded as strongly disagree, disagree, neutral, strongly, very strongly."|Weeks 16 up to 28|Part A ITT population|||percentage of preference|||Number
1442623|NCT00915343|Secondary|Participant Compliance- Part B|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets – Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Up to Month 6 follow-up|Part B ITT population with participants evaluable for this outcome.|||percentage use||Standard Deviation|Mean
1442624|NCT00915343|Secondary|Comparison on Participant Compliance Between Once Daily and Thrice Daily Therapy - Part A|Compliance was calculated as actual consumption/expected consumption Compliance = (Number of dispensed tablets – Number of returned tablets)/(Number of days during the study period x daily Number of hydrocortisone tablets when taking the ordinary daily dose).|Weeks 4 up to 28|Part A ITT population with participants evaluable for this outcome.|||percentage use||Standard Deviation|Mean
1442625|NCT00915343|Secondary|Change From Baseline to 6 Months in Diurnal Fatigue Questionnaire for Day Average- Part B|Diurnal fatigue scores (Visual Analog Scale [VAS] scores of energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442626|NCT00915343|Secondary|Change From Baseline to 12 Weeks in Diurnal Fatigue Questionnaire for Day Average of Once Daily Therapy - Part A|Diurnal fatigue was assessed at 8 ante meridian (AM), at 12 AM and at 4 post meridian (PM) by a visual analogue scale (VAS) based on 8 domains (energy, relaxed, less alert, moody, mental fatigue, intellectually slow, difficulty focusing, physical activity). Mean values were calculated for the morning (8 AM), the day (12 AM), the evening (4 PM) and mean per day (mean of 8 AM, 12 AM and 4 PM) were analyzed with score range from 0 to 100. A lower value corresponds to better well-being.|Baseline (week 0), Week 12|ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442627|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores- Part B|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442628|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Psychological General Well Being (PGWB) Total Scores Between Once Daily and Thrice Daily Therapy- Part A|The PGWB consists of 22 self-administered items rated on a scale from 1 (worst level of well-being) to 6 (maximum level of well-being) with a total score ranging from 22 to 132. A higher score represents better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442629|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score - Part B|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442630|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Fatigue Impact Scale (FIS) Total Score Between Once Daily and Thrice Daily Therapy - Part A|FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in participants. It consisted of 40 statements that measure fatigue in 3 areas: physical, cognitive, and psychosocial. This 40-item scale evaluates the construct of perceived impact of fatigue on everyday life. Respondents rated each statement using a 5-point Likert-type scale ranging from 0 (no problem) to 4 (extreme problem). A total score ranged from 0 to 160. A lower value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442631|NCT00915343|Secondary|Change From Baseline to 6 Months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score - Part B|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value in the SF-36 questionnaire corresponds to better well-being.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442632|NCT00915343|Secondary|Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical and Mental Component Score Between Once Daily and Thrice Daily Therapy- Part A|The SF-36 was a questionnaire used to assess physical functioning and is made up of eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Transforming and standardizing these domains lead to the calculation of the physical and mental component summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A higher value corresponds to better well-being.|12 weeks|Part A ITT population with participants evaluable for this outcome.|||scores on a scale||Standard Deviation|Mean
1442633|NCT00915343|Secondary|Percentage (%) of Participants With Change From Baseline in Patient Tolerability Questionnaire at Month 6, Assessed by Patient and Investigator – Part B|Patient tolerability questionnaire was assessed by both patient and investigator, the responses were as follows: improvement, no change, worsening and were reported.|Baseline (week 0), month 6|Part B ITT population with participants evaluable for this outcome.|||percentage of participants|||Number
1442634|NCT00915343|Secondary|Comparison of Overall Patient Tolerability Score Between Once Daily and Thrice Daily Therapy, Assessed by Patient and Investigator – Part A|"Overall patient tolerability score assessed by patient and investigator, ranged from 1 (feeling poor on treatment) to 5 (feeling very well on treatment). The average total score ranges from 1 to 5 with a higher score representing better tolerability of the treatment.~Questionnaire assessed by patient were I have been very poorly on the treatment, I haven’t been very well (or less well) on the treatment, I have been acceptably well on the treatment, I have been well on the treatment and I have been very well on the treatment. Questionnaire assessed by investigator were The patient has been feeling very poorly on the treatment, The patient has not tolerated the treatment well, The patient has tolerated the treatment less well, The patient has tolerated the treatment well and The patient has tolerated the treatment very well."|12 weeks|Part A ITT population|||scores on a scale||Standard Deviation|Mean
1442710|NCT00914862|Primary|Time to Reach Maximum Serum Concentration (Tmax)|Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||hours||Full Range|Median
1442635|NCT00915343|Secondary|Accumulation Ratio (Rac) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The Rac was calculated as area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) on Day 28 divided by AUC0-24h on Day 1. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||ratio||Standard Deviation|Mean
1442636|NCT00915343|Secondary|Percentage (%) of Fluctuation in Concentrations of S-cortisol at Steady State in Plasma After Single and Multiple Dosing During Part A|Percentage of fluctuation was calculated by using formula 100*(Cmax-minimum plasma concentration [Cmin])/Cavg,ss. It was peak trough fluctuation within one dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||percentage of fluctuation||Standard Deviation|Mean
1442637|NCT00915343|Secondary|Percentage (%) of Area Under the Concentration Time Curve (AUC) Extrapolation of S-cortisol in Plasma After Single and Multiple Dosing During Part A|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) was calculated by using the formula AUC%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter was to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t). Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||percentage of AUC||Standard Deviation|Mean
1442638|NCT00915343|Secondary|First Detectable Concentration Adjusted by Dose (Cfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||per liter||Standard Deviation|Mean
1442639|NCT00915343|Secondary|Time to First Detectable Concentration Adjusted by Dose (Tfirst/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||(hour per nanomole)*10^6||Standard Deviation|Mean
1442640|NCT00915343|Secondary|Maximal Concentration Adjusted by Dose (Cmax1/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||per liter||Standard Deviation|Mean
1442641|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State Adjusted by Dose (Css,av/Dose) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||per liter||Standard Deviation|Mean
1442642|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 4 Hours Adjusted by Dose (AUC0-4h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
1442643|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 10 Hours Adjusted by Dose (AUC0-10h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
1442644|NCT00915343|Secondary|Area Under the Concentration Time Curve From Zero to 24 Hours Adjusted by Dose (AUC0-24h/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
1442645|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State Adjusted by Dose (AUCtau/Dose) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 14 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour per liter||Standard Deviation|Mean
1442646|NCT00915343|Secondary|Area Under the Concentration Time Curve During a Dosing Interval at Steady State (AUCtau) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUCtau is defined as AUC during a dosing interval at steady state. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hour*nanomole per liter||Standard Deviation|Mean
1442647|NCT00915343|Secondary|Area Under the Concentration Time Curve (AUC) Between Specified Timepoints of Total S-cortisol in Plasma After Single and Multiple Dosing During Part A|"AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. AUC between specified timepoints included AUC0-4h, AUC4-12h, AUC6-12h, AUC12-24h, AUC0-10h, AUC4-10h, AUC6-10h, AUC10-24h, AUC(0-inf), AUC(24h-inf). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported. Here, Nsignifies the number of participants evaluable for this outcome."|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population.|||hour*nanomole per liter||Standard Deviation|Mean
1442648|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 14 Hours (t1/2[5-14h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-14h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 14 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Standard Deviation|Mean
1442649|NCT00915343|Secondary|Drug Concentration Half-Life From 5 to 24 Hours (t1/2[5-24h]) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|t1/2[5-24h] is the time taken for the blood plasma concentration of a drug to halve from 5 to 24 hours. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Standard Deviation|Mean
1442650|NCT00915343|Secondary|Time to Reach a Concentration of 200 Nanometers (nM) (T200) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
1442651|NCT00915343|Secondary|Time to First Detectable Concentration (Tfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
1442652|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax2 is the Tmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
1442653|NCT00915343|Secondary|Time to Peak Plasma Concentration (Tmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. Tmax1 is the Tmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||hours||Full Range|Median
1442654|NCT00915343|Secondary|Concentration at 7 Hours (C7h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
1442655|NCT00915343|Secondary|Concentration at 6 Hours (C6h) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
1442656|NCT00915343|Secondary|First Detectable Concentration (Cfirst) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
1442657|NCT00915343|Secondary|Average Concentration of S-cortisol During the Dosing Interval at Steady State (Css,av) in Plasma After Single and Multiple Dosing During Part A|Css,av was calculated as the area under the S-cortisol concentration versus time curve during a dosing interval at steady state (AUCtau) divided by dosing interval (tau). Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
1442658|NCT00915343|Secondary|Maximal Concentration (Cmax2) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax2 is the Cmax after second dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
1442659|NCT00915343|Secondary|Maximal Concentration (Cmax1) of S-cortisol in Plasma After Single and Multiple Dosing During Part A|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. Cmax1 is the Cmax after first dose of study drug. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The average of single and multiple dosing for combined arm 1+2 was reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A ITT population with participants evaluable for this outcome.|||nanomoles per liter||Standard Deviation|Mean
1442660|NCT00915343|Primary|Area Under the Concentration Time Curve From Zero to 24 Hours (AUC0-24h) of Total S-cortisol in Plasma After Multiple Doses During Part A|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. Participants in Arm 1 underwent standardised in-house PK sampling during 24 hours in order to assess single-dose PK of OD or TID regimen at the start of each study treatment period while participants in Arm 2 had a reduced PK sampling scheme of single dose PK on Days 1-2 and returned for multiple-dose PK sampling on Days 7-8. The data for combined arm 1+2 after multiple doses were reported.|Arm 1: Week 4, Week 16, Week 16 + 1 day, Week 28; Arm 2: Week 4, Week 4 + 7 days, Week 16, Week 16 + 7 days|Part A: Intention-To-Treat (ITT) set included all randomised participants who took at least 1 dose of study drug with primary efficacy assessments including all pharmacokinetic (PK) samplings during either treatment period. Here “number of participants analysed” signifies those who were evaluable for the outcome measure.|||hour*nanomole per liter||Standard Deviation|Mean
1442661|NCT00915278|Secondary|Number of Participants With Perforin Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Perforin.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442662|NCT00915278|Secondary|Number of Participants With Ki67 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Ki67.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442663|NCT00915278|Secondary|Number of Participants With Caspase 3 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Caspase 3.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442664|NCT00915278|Secondary|Number of Participants With CD31 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD31.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442665|NCT00915278|Secondary|Number of Participants With pFAK Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against pFAK.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442666|NCT00915278|Secondary|Number of Participants With CD16 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD16.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD16 expression.|||Participants|||Number
1442667|NCT00915278|Secondary|Number of Participants With CD56 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against CD56.|Predose and postdose|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CD56 expression.|||Participants|||Number
1442668|NCT00915278|Secondary|Number of Participants With Granzyme B Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against Granzyme B.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442669|NCT00915278|Secondary|Number of Participants With CD68 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies CD68.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442670|NCT00915278|Secondary|Number of Participants With Integrin Alpha 5 Beta 1 Expression|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against integrin alpha 5 beta 1.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442671|NCT00915278|Secondary|Number of Participants With Tissue Macrophage Infiltration|Immunohistochemical staining of tissue biopsies was performed with monoclonal antibodies directed against tissue macrophages.|Predose and postdose|The data was not statistically analyzed as planned due to early study termination.||||||
1442672|NCT00915278|Secondary|Percent Change in Initial Area Under the Curve (IAUC)|Percent change in the IAUC for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 Day 15. IAUC reflects the contrast distribution volume (extravascular extracellular space) in addition to contrast delivery and transport across the vascular endothelium. An IAUC value of zero indicates the absence of disease (ie, no leakage of the contrast agent into the synovial volume); therefore, an increase in this parameter indicates worsening disease (ie, greater permeability of the synovial membrane).|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.||||||
1442673|NCT00915278|Secondary|Percent Change in Transfer Constant (Ktrans) From Baseline to Cycle 1 Day 15|Percent change in Ktrans for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) from baseline to Cycle 1 day 15 aimed at defining the effect of PF-04605412 on tumor vasculature.|Screening, and Cycle 1 Day 15|The data was not statistically analyzed as planned due to early study termination.||||||
1442674|NCT00915278|Secondary|Objective Response - Number of Participants With Objective Response|"Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.~Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions."|Baseline up to 6 weeks after the first infusion of PF-04605412 (end of Cycle 2) and approximately every 6 weeks thereafter only in the absence of progressive disease|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.|||participants|||Number
1442675|NCT00915278|Secondary|Number of Participants Positive for Anti-PF04605412 Antibodies|Serum samples were analyzed for anti-drug antibodies (ADA) or human anti-human antibodies (HAHA). This was used to evaluate immunogenicity.|Baseline up to end of treatment|All subjects enrolled in this study who were treated with at least one dose of PF-04605412.|||participants|||Number
1442676|NCT00915278|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Vss.|||Liter||Geometric Coefficient of Variation|Geometric Mean
1442677|NCT00915278|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable CL.|||Liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1442678|NCT00915278|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Tmax.|||hours||Full Range|Median
1442679|NCT00915278|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable t1/2.|||hours||Standard Deviation|Mean
1442680|NCT00915278|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]|AUC (0 - inf)= Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUC (0 - inf).|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1442681|NCT00915278|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from zero to the last measured concentration (AUClast).|Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable AUClast.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1442682|NCT00915278|Secondary|Maximum Observed Serum Concentration (Cmax)||Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1|The analyzed population is all enrolled subjects treated who had received at least 1 dose of PF-04605412 and completed sampling for PK profiles for PF‑04605412; N = number of subjects who had reportable Cmax.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1442683|NCT00915278|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any >= Grade 3 adverse event (AE) graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF‑04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.|Baseline up to 6 weeks PF-04605412|All subjects enrolled in the dose escalation part of the study who received at least one dose of study medication that remained on study and/or provided safety follow-up for at least 6 weeks, unless discontinuing due to a DLT. Subjects discontinuing the study due to DLT are included|||participants|||Number
1442684|NCT00915148|Secondary|Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)||6 hours post determination of prolonged labor||||percentage of participants|||Number
1442685|NCT00915148|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound|Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.|during labor||||percentage probability||95% Confidence Interval|Number
1442686|NCT00915018|Secondary|Symptomatic or Progressive Central Nervous System (CNS) Lesions|"Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable.~If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead."|From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years|all randomized patients|||Participants|||Count of Participants
1442687|NCT00915018|Secondary|Clinical Benefit Rate|Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From randomization to disease progression or death, assessed up to 5.3 years|all randomized patients|||percentage of participants||95% Confidence Interval|Number
1442688|NCT00915018|Secondary|Duration of Response|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first response to first PD or death, assessed up to 5.3 years after first subject randomized|patients who responded|||months||95% Confidence Interval|Median
1442689|NCT00915018|Secondary|Objective Response Rate|Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-Progressive Disease for non-target lesions, and no new lesions.|From randomization to disease progression or last tumor assessment, assessed up to 5.3 years|all randomized patients|||percentage of participants||95% Confidence Interval|Number
1442690|NCT00915018|Primary|Progression-Free Survival|Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.|From randomization to disease progression or death, assessed up to 5.3 years|all randomized patients|||months||95% Confidence Interval|Median
1442691|NCT00914966|Secondary|Use of Rescue Therapy and/or Other Therapy for Treatment of HAE Symptoms||12 weeks at each dose level|||||||
1442692|NCT00914966|Secondary|Treatment Effect of Escalating Doses of CINRYZE on HAE Attack Rates|"Two definitions of success were applied in this study:~Per-protocol success - Average angioedema attack rate of ≤1.0 per month at the end of any dose escalation step (Week 12). The a priori definition of study success was 4 or more subjects with per-protocol success.~Investigator-determined success - Based on the investigator's clinical judgment, an average monthly angioedema attack rate demonstrating improvement sufficient for progression to follow-up.~In addition, subjects who were not a per-protocol or investigator-determined success, but who experienced a reduction of >1.0 attack per month from their historical angioedema attack rate at the end of any dose escalation step (Week 12), were summarized."|12 weeks at each dose level||||participants|||Number
1442693|NCT00914966|Primary|Number of Subjects With Adverse Events, Hospitalizations, Thrombotic Events, Treatment-emergent C1 INH Antibodies, Post-baseline Toxicity Grade Increases in Clinical Laboratory Parameters, and Post-dose Vital Signs Changes of Potential Clinical Importance|Events reported during the 3 month follow-up period are counted with the dose level at which they occurred.|12 to 24 weeks at each dose level||||participants|||Number
1442694|NCT00914927|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 4 (Visit 3) and Day 8 (Visit 5, EOT)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
1442695|NCT00914927|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than 75,000/mm^3 on Day 4|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 4 (Visit 3)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
1442696|NCT00914927|Secondary|Percentage of Participants Experiencing Dose-response by Visit|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 4 (Visit 3), Day 6 ( Visit 4), Day 8 (Visit 5, EOT), 3 Day Post Last Dose (Visit 6), and 7 Day Post Last Dose (Visit 7)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
1442709|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc])|Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||ng*hr/mL||Standard Deviation|Mean
1446889|NCT00877929|Secondary|Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks|Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg|Baseline, week 8|Treated set using last observation carried forward (LOCF)|||participants|||Number
1442697|NCT00914927|Secondary|Change in Platelet Count on Day 8 (Visit 5 and/or End of Treatment) From Baseline|Platelet counts were determined from blood draws. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (EOT), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 8 (Visit 5, EOT)|Intent-to-treat population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||K/mm^3||Standard Deviation|Mean
1442698|NCT00914927|Primary|Percentage of Participants Experiencing Response|Platelet counts (PC) were determined from blood draws. A responder is defined as a participant having an increase of at least 20,000/mm^3 PC from Baseline and a PC greater than 50,000/mm^3 at least once during Day 4 through Day 8. Missing PC assessments at any given time point was considered to be a non-response at that point and were not estimated. For PC measurements taken after the last dose day (end of treatment (EOT)), the postdose windows applied. If there was more than one PC within the same analysis visit window, the following selection rules were applied sequentially to determine which PC was used for that time point: 1) the PC that was closer to the target date was used, 2) if PC were equal-distance in days from the target day, the later one based on measurement date and time was used, and 3) if there was more than one PC on the same day, if it was a baseline record, the largest one was used; if it was a postbaseline record, the smallest one was used.|Day 8 (Visit 5, EOT)|Intent-to-treat (ITT) population included all participants who were randomized into the study, received study medication, and had a posttreatment assessment. The ITT population was analyzed as randomized.|||Percentage of participants|||Number
1442699|NCT00914862|Secondary|Number of Participants With Clinically Significant Physical Examination Results|A complete physical examination was performed for each participant at Screening, Check-in (Day 1), Day 2, and Final Visit (Day 4) or Early Termination. The examination consisted of a review of the following body systems: eyes; ears, nose, and throat; respiratory; gastrointestinal; extremities; musculoskeletal; cardiovascular; nervous; and dermatological.|Screening, Day 1, Day 2 and Day 4|Safety set.|||participants|||Number
1442700|NCT00914862|Secondary|Number of Participants With Clinically Significant Electrocardiogram Findings|A standard 12-lead electrocardiogram (ECG) was recorded at Screening, Day 2, and at Final Visit (Day 4). The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Screening, Day 2 and Day 4|Safety set.|||participants|||Number
1442701|NCT00914862|Secondary|Number of Participants With Clinically Significant Vital Signs|Vital signs included oral body temperature, pulse and blood pressure (taken after 5 minutes in the sitting position). Vital signs measurements were determined to be clinically significant according to predefined criteria.|Screening, Day 1, Day 2 and Day 4|Safety set.|||participants|||Number
1442702|NCT00914862|Secondary|Number of Participants With Clinically Significant Laboratory Findings|Laboratory samples were collected at Screening, Check-in (Day 1), and Day 2 or Early Termination for assessment of hematology, chemistry, and urinalysis.|Screening, Day 1, Day 2 and Day 4|Safety set.|||participants|||Number
1442703|NCT00914862|Secondary|Number of Participants With Adverse Events (AE)|"An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it did not necessarily have to have a causal relationship with this treatment. The different categories of intensity (severity) were characterized as follows:~Mild: The event was transient and easily tolerated by the participant.~Moderate: The event causes the participant discomfort and interrupted usual activities.~Severe: The event causes considerable interference with the participant’s usual activities."|Day 1 to Day 15|The safety set includes all participants who received at least 1 dose of study drug.|||participants|||Number
1442704|NCT00914862|Primary|Apparent Volume of Distribution (Vz/F)|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||Liters||Standard Deviation|Mean
1442705|NCT00914862|Primary|Terminal Elimination Half-life (T1/2)|Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln[2]) / Terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||hours||Standard Deviation|Mean
1442706|NCT00914862|Primary|Terminal Elimination Rate Constant (λz)|The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||1/hour||Standard Deviation|Mean
1442707|NCT00914862|Primary|Apparent Clearance After Oral Administration (CL/F)|"Apparent oral clearance of drug from the serum calculated as:~CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf])."|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||L/hr||Standard Deviation|Mean
1442708|NCT00914862|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC[0-inf])|Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|Pharmacokinetic set where valid PK parameter estimates were available.|||ng*hr/mL||Standard Deviation|Mean
1442711|NCT00914862|Primary|Maximum Observed Serum Concentration (Cmax)|Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.|Day 1: predose (within 1 hour prior to dose) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours post-dose.|The Pharmacokinetic (PK) set, which consisted of all patients who received study drug and had sufficient concentration data to calculate at least 1 PK parameter.|||ng/mL||Standard Deviation|Mean
1442712|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure||Up to Day 2||||participants|||Number
1442713|NCT00914849|Secondary|Rate of Chronic GVHD in Recipients||Day 101-1 year|8 patients are not evaluable because they were not alive for the outcome measure time frame.|||participants|||Number
1442714|NCT00914849|Secondary|Grade 3-4 Toxicity for Recipients|Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.|1 year||||participants|||Number
1442715|NCT00914849|Secondary|Transplant Related Mortality Rate for Recipients|Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.|Day 100||||participants|||Number
1442716|NCT00914849|Secondary|Time to Platelet Engraftment for Recipients|Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.|Up to Day 100||||days||Full Range|Median
1442717|NCT00914849|Secondary|Time to Neutrophil Engraftment for Recipients|Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.|Up through Day 100||||days||Full Range|Median
1442718|NCT00914849|Secondary|Rate of Acute GVHD (Grade III-IV) in Recipients||Day 0-Day 100 (acute)||||participants|||Number
1442719|NCT00914849|Secondary|Rate of Acute GVHD (Grade II-IV) in Recipients||Day 0-Day 100 (acute)||||participants|||Number
1442720|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)||Day 1 and Day 2||||hr.ng/mL||Standard Deviation|Mean
1442721|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by Half Life|"-Blood samples for pharmacokinetics were drawn on the following schedule:~prior to IV infusion~15 minutes after start of infusion~30 minutes after start of infusion~1 hour after start of infusion~4 hours after start of infusion~6 hours after start of infusion~9 hours after start of infusion~24 hours after start of infusion"|Day 1 and Day 2||||hours||Standard Deviation|Mean
1442722|NCT00914849|Secondary|Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)|"-Blood samples for pharmacokinetics were drawn on the following schedule:~prior to IV infusion~15 minutes after start of infusion~30 minutes after start of infusion~1 hour after start of infusion~4 hours after start of infusion~6 hours after start of infusion~9 hours after start of infusion~24 hours after start of infusion"|Day 1 and Day 2||||ng/mL||Standard Deviation|Mean
1442723|NCT00914849|Secondary|Number of Recipients Who Have Neutrophil Engraftment||Day 21||||participants|||Number
1442724|NCT00914849|Secondary|Number of Donors Who Experience Grade 3-4 Infusional Toxicity||Up to Day 2||||participants|||Number
1442725|NCT00914849|Primary|Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant||Completion of enrollment of all donors (17 months)|3 donors failed to reach target after two collections and 1 donor withdrew consent after failing to reach the goal on the first collection.|||participants|||Number
1442726|NCT00914810|Secondary|Change in Blood Level of Vitamin D (25-hydroxyvitamin D)||Baseline and 6 weeks|25-hydroxyvitamin D levels missing for 2 participants in the vitamin D arm of the trial.|||ng/mL||Standard Deviation|Mean
1442727|NCT00914810|Primary|Change in Short Physical Performance Battery (SPPB) Score|SPPB measures lower extremity strength using 3 simple office-based tests to assess standing balance, gait speed, and chair stands. The composite SPPB score ranges from 0 (worst performance) to 12 (best performance). The minimal clinically important difference is not fully agreed upon, although a difference of 1.0 point has been used in many studies.|Baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
1442728|NCT00914589|Secondary|Percentage of Subjects With Serious Adverse Events|Percentage of subjects with serious adverse events until end of trial.|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.|||percentage (%) of subjects|||Number
1442729|NCT00914589|Secondary|Percentage of Subjects With Critical Adverse Events|Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.|||percentage (%) of subjects|||Number
1442730|NCT00914589|Secondary|Percentage of Subjects With rFXIII Antibody Reaction|Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.|measured from screening until 5-7 weeks post Trial Drug Administration|Safety analysis set includes all subj. exposed to at least one dose of trial product. 1 subj with a low titre antibody at baseline was also reported with low titre FXIII antibody at visit 8. 27, 19 and 17 subjects in placebo, FXIII 17.5 and 35 IU/KG, respectively, did not have antibody measurement.|||participants|||Number
1442731|NCT00914589|Secondary|Percentage of Subjects With Thromboembolic Events|Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial|measured from screening until 5-7 weeks post Trial Drug Administration|The safety analysis set included all subjects who were exposed to at least one dose of trial product.|||percentage of subjects|||Number
1442732|NCT00914589|Primary|Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First|Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.|measured ongoing from dosing until day 7 or discharge, whichever came first|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment.|||percentage (%) of subjects|||Number
1442733|NCT00914485|Primary|Change in Provider Use of Best Acts From Baseline to Post-Intervention|"Mean per-patient use of best acts learned during provider communication skills intervention, post-intervention minus baseline."|Baseline, 18 months||||best acts per patient||Standard Deviation|Mean
1442734|NCT00914459|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): All Participants|An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 30 days after last study visit (Month 25)|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||participants|||Number
1442735|NCT00914459|Secondary|Mean Residence Time (MRT) of ReFacto AF|MRT was calculated as AUMCinf / AUCinf-TI/2, where AUMCinf is the area under the first moment curve from time zero to infinity and TI was the duration of infusion.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||hour||Full Range|Median
1442736|NCT00914459|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1442737|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)|AUClast is the area under the plasma versus time curve from time zero to time of last measurable concentration (AUClast)|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1442738|NCT00914459|Secondary|Area Under the Plasma Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was calculated as International units*hour per milliliter (IU*hr/mL).|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||IU*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1442739|NCT00914459|Secondary|Plasma Concentration of Factor VIII at 0.5 Hour Post-dose (C0.5)||0.5 hour post-dose on Day 1|The PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
1442740|NCT00914459|Secondary|Number of Participants Requiring Escalated Dose of Prescribed Regimen During the Treatment Period: All Participants|Participants who met the dose escalation criteria were prescribed a higher dose and/or more frequent doses as per the investigator’s discretion.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who used a prophylaxis regimen were analyzed for this outcome measure.|||participants|||Number
1442741|NCT00914459|Secondary|Number of Occurrences of Less-Than-Expected-Therapeutic Effect (LETE) in the Low Recovery Setting: All Participants|LETE in the low recovery setting was defined as lower than expected recovery of FVIII (in the opinion of investigator), following the infusion of ReFacto AF in the absence of confounding factors for the low recovery. The only confounding factors for low recovery are as follows: known presence or subsequent identification of a FVIII inhibitor, known compromised ReFacto AF, faulty administration of ReFacto AF, including inadequate dosing.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||LETE bleeds|||Number
1442742|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the Prophylaxis Setting: All Participants|LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (<=48 hours) after a regularly scheduled prophylactic dose of ReFacto AF (which was not used to treat a bleed) in the absence of confounding factors. Therefore, LETE in the prophylaxis setting is the occurrence of a bleed. Confounding factors include: Known presence or subsequent identification of a FVIII inhibitor, known inadequate prophylactic dose, known lack of adherence to the prescribed prophylaxis regimen, bleed occurs in a target joint identified at the start of the study, known compromised ReFacto AF, faulty administration of ReFacto AF, an underlying, predisposing condition responsible for the bleed in the opinion of the investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs) or traumatic injury responsible for bleeding.|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Participants who received at least 1 prophylaxis dose of ReFacto AF were reported.|||LETE bleeds|prophylaxis infusions||Number
1442763|NCT00914069|Secondary|Summary of Minor Complications|Any device-related or procedure-related adverse event that causes clinically inconsequential symptoms to the patient.|Post-PIV placement until catheter removal (usually within 4 days)||||participants|||Number
1442743|NCT00914459|Secondary|Number of Less-Than-Expected-Therapeutic Effect (LETE) Bleeds in the On-Demand Setting: All Participants|"LETE in on-demand setting was based on response to treatment of a bleeding episode. LETE in the on-demand setting occurred if participant recorded 2 successive no response ratings after 2 successive ReFacto AF infusions. Both infusions were to be administered at an interval of 24 hours for treatment of same bleeding event in absence of confounding factor which included: known presence or subsequent identification of a FVIII inhibitor, known inadequate dose for type and/or severity of bleed in opinion of investigator, delay of greater than 4 hours between onset of bleed to infusion, delay of greater than 24 hours before administration of a follow-up infusion, known compromised ReFacto AF, faulty administration of ReFacto AF, participant had an underlying, predisposing condition responsible for bleed in opinion of investigator (e.g., kidney stones or use of medications known to impair platelet function, such as aspirin or NSAIDs),or ongoing trauma responsible for continued bleeding."|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, “number of participants analyzed” signifies participants who were evaluable for this outcome measure and received treatment for at least one bleed.|||LETE bleeds|bleeding episodes||Number
1442744|NCT00914459|Secondary|Total Factor VIII Consumption: All Participants|Total factor VIII consumption for each participant was calculated by sum of the total amount of ReFacto AF (in IU) infused for each ReFacto AF infusion (recorded in the infusion log diary CRF). Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."|||IU||Standard Deviation|Mean
1442745|NCT00914459|Secondary|Average Infusion Dose of ReFacto AF: All Participants|The average infusion dose (by weight) for each participant was calculated as his total factor FVIII consumption (in IU) divided by weight (in kg) divided by the number of infusions administered in total study duration. Data was reported separately for participants classified at baseline as following non-prophylaxis regimen (for example: on-demand regimen, preventive, or not specified), and participants classified at baseline following a primary or secondary prophylaxis regimen.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable for each specified baseline category."|||IU/kg||Standard Deviation|Mean
1442746|NCT00914459|Secondary|Number of Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of ReFacto AF: All Participants|The number of breakthrough bleeds within 48 hours following a prophylaxis dose of ReFacto AF was summarized. The infusion log diary CRF was used to determine the number of infusions administered to treat a new bleed counting only those infusions which were administered <=48 hours after an infusion marked as “prophylaxis” (which had no associated bleed).|Baseline up to Month 24|Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||breakthrough bleeds||Standard Deviation|Mean
1442747|NCT00914459|Secondary|Number of On-Demand ReFacto AF Infusions to Treat a New Bleed: All Participants|"The infusion log diary case report form (CRF) was used to determine the number of on-demand (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) ReFacto AF infusions administered to treat a new bleed. This was calculated by adding the initial for a new bleed (on-demand) infusion to any subsequent (on-demand) infusions for the same previously treated bleed (same bleed with same start date/time)."|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure."|||infusions|bleeds|Standard Deviation|Mean
1442748|NCT00914459|Secondary|Response to First On-Demand Treatment for New Bleeds: All Participants|A 4-point scale of assessment of ‘on-demand’ treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: 1. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. 2. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode;or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following infusion, with no additional infusion administered. 3. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. 4. No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and received at least 1 dose of ReFacto AF for at least one bleeding episode."|||responses|bleeds||Number
1442749|NCT00914459|Secondary|Mean Annualized Bleeding Rates (ABRs): All Participants|ABR for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by the total therapy duration (in days), then multiplied by 365.25. ABR for the participants who reported following a primary or secondary prophylaxis, on-demand regimen or preventive regimen at baseline were reported.|Baseline up to Month 24|"Efficacy analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at the specified time points."|||bleeds per year||Standard Deviation|Mean
1442750|NCT00914459|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||milliliter per hour per kilogram||Geometric Coefficient of Variation|Geometric Mean
1449220|NCT00856908|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
1442751|NCT00914459|Primary|Terminal Elimination Half Life of ReFacto AF (t1/2)|T1/2 was the time for the plasma concentration of drug to decrease by one-half of its original concentration.|Pre-dose, 0.5, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose on Day 1|"PK parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data was not planned to be collected and analyzed for reporting arm “ReFacto AF: Less Than 6 Years”, as pre-specified in protocol."|||hours||Standard Deviation|Mean
1442752|NCT00914459|Primary|Incremental Recovery|Incremental recovery was the increase in circulating FVIII activity for every international unit (IU) of ReFacto AF administered per kilogram of body weight. It was measured in international units per deciliter (IU/dL) per international units per kilogram (IU/kg).|Days 1, 15, 50, Months 6, 18 and Final visit (up to Month 24)|"The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of ReFacto AF. Here, n signifies participants who were evaluable at the specified time point for each arm respectively."|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
1442753|NCT00914459|Primary|Percentage of Participants With Clinically Significant Factor VIII Inhibitor Development|Clinically significant factor VIII (FVIII) inhibitors were defined as a central laboratory confirmed positive inhibitor of greater than or equal to (>=) 0.6 Bethesda units (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval and one of the following within 4 weeks before the initial or within 4 weeks following the second positive FVIII inhibitor sample collection: 1) the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, 2) >=2 events indicating a decrease in the efficacy of the study treatment. Percentage of participants who developed clinically significant Factor VIII inhibitor after study drug administration were reported.|Baseline up to Month 24|Safety analysis population included all enrolled participants who received at least 1 dose of ReFacto AF.|||percentage of participants||95% Confidence Interval|Number
1442754|NCT00914316|Secondary|Percentage Increase in Absolute Walking Distance Following Phase 2|Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test|24 weeks|Missing data from one subject 24 week treadmill test in placebo/placebo group|||percentage of baeline||Inter-Quartile Range|Median
1442755|NCT00914316|Primary|Percentage Increase in Absolute Walking Distance Following Phase 1|Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test|12 weeks|Missing data for 12 week test in 1 subject in Ranolazine/Ranolazine group, 1 subject in Ranolazine/placebo group, and 3 subjects in placebo/placebo group|||percentage of baseline||Inter-Quartile Range|Median
1442756|NCT00914186|Primary|Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale|"Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from No Itch, even the slightest itch or Slight Itch, to Worst Itch Imaginable to denote the increase in severity of itching."|Baseline through Study Day 36 (Visit 7)||||participants|||Number
1442757|NCT00914186|Primary|Skindex-29 Questionnaire to Measure the Subject’s Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.|Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject’s overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.|Study Day -7 through Study Day 22|ITT|||units on a scale||Standard Deviation|Mean
1442758|NCT00914186|Primary|Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas|The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.|baseline through Study Day 36 (Visit 7)|ITT analysis|||units on a scale||Standard Deviation|Mean
1442759|NCT00914186|Primary|Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score|self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)|Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)|ITT|||units on a scale||95% Confidence Interval|Mean
1442760|NCT00914186|Primary|Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas|investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)|baseline through Study Day 36 (Visit 7)|ITT|||units on a scale||95% Confidence Interval|Mean
1442761|NCT00914186|Primary|Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events|Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms|Baseline through Study Day 36 (Visit 7)|total number of subjects who received study drug.|||participants|||Number
1442762|NCT00914186|Primary|Change in Pruritis Visual Analog Scale (VAS)|Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale|Baseline through Study Day 36 (Visit 7)|Intent To Treat (ITT) analysis|||mm||Standard Deviation|Mean
1442764|NCT00914069|Secondary|Second Stick Success Rate|A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.|Number of Participants Analyzed is not consistent with numbers provided in the Participant Flow Module because not all participants required a second attempt at catheter placement.|||participants|||Number
1442765|NCT00914069|Secondary|Time Required to Obtain Access|A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.||||minutes||Standard Deviation|Mean
1442766|NCT00914069|Primary|Summary of Major Complications|Any device-related or procedure-related adverse event that causes clinically consequential symptoms to the patient. These may include access site hematoma, bleeding, infection, nerve injury, vessel laceration, wound dehiscence, allergic reaction, or inflammation, among others.|Post-PIV placement until catheter removal (usually within 4 days)||||participants|||Number
1442767|NCT00914069|Primary|IV Insertion Success Rate at First Attempt IV Insertion Success Rate at First Attempt|A successful IV insertion includes all of the following: initial vein penetration, which is visualized by a flash back of blood into the access device, deployment of the guidewire, advancement of the catheter into the vein, retraction of needle and guidewire, and flushing of IV. A secured flushed IV will be indicative of a successful PIV placement.|An access attempt usually ranges from 0 to 45 minutes in duration.||||participants|||Number
1442768|NCT00913913|Other Pre-specified|Clinical Response|clinical response by RECIST 1.1|Day 70||||participants|||Number
1442769|NCT00913913|Other Pre-specified|Measure of Percent of CD4 and CD8 Lymphocyte Subsets|percent of CD4 and CD8 positive lymphocyte subsets|Baseline, day 28, day 70|Peripheral blood lymphocyte subsets: 5 subjects at baseline and same 5 at day 70. 6 subjects analyzed at day 28|||percentage of total lymphocytes||Full Range|Mean
1442770|NCT00913913|Secondary|To Characterize the Number of Participants With Clinical and Autoimune Related Toxicity of Treatment|To characterize the clinical and autoimmune related toxicity profile of the combined treatment regimen using CTCAE 3. Toxicity reported are those expected from high dose IL-2 and were not considered adverse events.|5 years||||participants|||Number
1442771|NCT00913913|Primary|Progression Free Survival|median progression free survival|5 years||||DAYS||Full Range|Median
1442772|NCT00913835|Secondary|PFS for Participants Who Had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association Between PDGFRα Tumor Expression and PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is >0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.|Randomization to PD or Date of Death (Up to 130 Weeks)|All participants who had evaluable PDGFRα results.|||weeks||95% Confidence Interval|Median
1442773|NCT00913835|Secondary|Apparent Volume of Distribution (Vss) of Olaratumab|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
1442774|NCT00913835|Secondary|Clearance (CL) of Olaratumab|CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
1442775|NCT00913835|Secondary|Half-life (t1/2) of Olaratumab|The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.|Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
1442776|NCT00913835|Secondary|Maximum Concentration (Cmax) of Olaratumab||Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
1442777|NCT00913835|Secondary|Area Under the Curve (AUC) of Olaratumab||Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)|Zero participants were analyzed. An insufficient amount of samples were collected to derive this measure.||||||
1442778|NCT00913835|Secondary|PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)|PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. PD is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.|From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)|Participants who received Olaratumab treatment after PD on liposomal doxorubicin monotherapy. Participants censored=4|||weeks||90% Confidence Interval|Median
1442800|NCT00913627|Secondary|Time to Meaningful Pain Relief|Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that is considered meaningful to the participant.|Baseline to 6 hours|ITT population|||minutes||95% Confidence Interval|Median
1442779|NCT00913835|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies|Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Baseline Up to 30-Day Postdose Follow-Up (Up To 35 Months)|All randomized participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.|||percentage of participants|||Number
1442780|NCT00913835|Secondary|Number of Participants With Adverse Events (AEs) and Who Died|Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.|Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)|All randomized participants who received any amount of study drug.|||participants|||Number
1442781|NCT00913835|Secondary|Median Duration of Response|Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.|Date of Initial CR or PR to PD (Up to 35 Months)|All participants who achieved CR or PR. Participants censored: Olaratumab=2, Liposomal Doxorubicin=4.|||weeks||90% Confidence Interval|Median
1442782|NCT00913835|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) * 100.|Randomization to PD (Up to 35 Months)|mITT Population: All randomized participants who received any amount of study drug.|||percentage of participants||90% Confidence Interval|Number
1442783|NCT00913835|Secondary|Overall Survival (OS)|OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.|First Day of Therapy to Date of Death (Up to 35 Months)|mITT Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=21, Liposomal Doxorubicin=23.|||weeks||90% Confidence Interval|Median
1442784|NCT00913835|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Progressive Disease (PD) is a 20% increase over the smallest sum of target lesions or new lesions. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.|Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)|Modified Intent to Treat (mITT) Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=13, Liposomal Doxorubicin=14.|||weeks||90% Confidence Interval|Median
1442785|NCT00913770|Secondary|Days of Self-reported Illicit Opioid Use in the Past 7 Days||30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104|||Mean Number of Days||95% Confidence Interval|Mean
1442786|NCT00913770|Primary|Self-reported Engagement in Formal Substance Abuse Treatment at 30 Days (Verified by Contact With the Treatment Program)|Defined as enrollment and receiving formal addiction treatment on the 30th day following randomization. This is assessed by direct contact with facility, clinician, or both.|30 days post randomization|All subjects who were randomized to receive treatment were included in the primary analysis. 2 subjects were lost to follow up in the standard of care arm which is why 102 are included in the analysis instead of 104|||Mean Number of Outpatient Visits||95% Confidence Interval|Mean
1442787|NCT00913744|Primary|Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28|The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation|Day 28|The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method.|||percentage of subjects|||Number
1442788|NCT00913692|Secondary|Does Oral Glutamine Reduce the Area of Recurrent Lesions?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences, start and end dates of each recurrence and measurement of each lesion during each phase of the study would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||mm squared||Standard Deviation|Median
1442801|NCT00913627|Secondary|Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief|The elapsed time from dosing until the participant indicated first perceptible relief, provided the participant also indicated achieving meaningful relief. Perceptible relief defined as when participant first begins to feel any pain-relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she currently has now.|15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes|ITT population|||percentage of participants|||Number
1442789|NCT00913692|Secondary|Does Oral Glutamine Reduce the Duration of Recurrences?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||days||Standard Deviation|Median
1442790|NCT00913692|Secondary|Does Oral Glutamine Reduce the Time to First Recurrence of Herpes Labialis Diagnosed by Clinical and Microbiologic Criteria or Diagnosed by Clinical Criteria With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences and start and end dates of each recurrence would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||days||Standard Deviation|Median
1442791|NCT00913692|Secondary|Does Oral Glutamine Reduce the Number of Clinical Recurrences of Herpes Labialis With or Without PCR Confirmation?|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of recurrences would be documented during each phase of the study.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.|||herpes labialis lesions||Standard Deviation|Median
1442792|NCT00913692|Primary|Does Oral Glutamine Reduce the Number of Recurrences of Herpes Labialis, Diagnosed by Clinical and Microbiologic Criteria, in Healthy Participants With Frequently Recurrent Disease.|During all phases of the study, participants returned to clinic whenever they had a herpes labialis outbreak for staff to assess, obtain a viral swab and document. If unable to return to clinic in the time frame specified in the protocol, participants would take a photo and obtain a swab of the lesion. The number of outbreaks would be measured during each phase.|The screening phase time frame was 4 months. Treatment phase 1 was 5 months. Washout phase was 2 weeks. Treatment phase 2 was 5 months.|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.|||herpes labialis lesions|||Number
1442793|NCT00913627|Secondary|Peak Pain Relief Score|"Maximum PR score over the scheduled pain relief assessments. PR score based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief)."|Baseline to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
1442794|NCT00913627|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Score|PRID=PID+PR, where PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline and could range from -1 to 3. Baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated improvement. PR: 5-point categorical pain relief scale (None [0], A Little [1], Some [2], A Lot [3], Complete [4]). PRID score could range from -1 to 7 where higher scores indicated better pain relief and decrease in pain intensity.|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours|ITT population.|||units on a scale||Standard Deviation|Mean
1442795|NCT00913627|Secondary|Pain Relief (PR) Score|"PR score based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None [0], A Little [1], Some [2], A Lot [3] or Complete [4]. Higher scores indicated improvement (better pain relief)."|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours|ITT population.|||units on a scale||Standard Deviation|Mean
1442796|NCT00913627|Secondary|Pain Intensity Difference (PID) Score|"PID based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). PID score derived by subtracting postdose score from baseline score and could range from -1 to 3. A baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated greater improvement (decrease in pain intensity)."|15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours|ITT population.|||units on a scale||Standard Deviation|Mean
1442797|NCT00913627|Secondary|Participant Global Evaluation of Study Medication at 24 Hours|Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).|24 hours|ITT population; Number of participants analyzed (N)= participants with evaluable data|||participants|||Number
1442798|NCT00913627|Secondary|Participant Global Evaluation of Study Medication at 12 Hours|Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5).|12 hours|ITT population|||participants|||Number
1442799|NCT00913627|Secondary|Percentage of Participants Achieving Meaningful Pain Relief|Participants evaluated the time to first perceptible pain relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief defined as relief from the pain that is considered meaningful to the participant.|15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes|ITT population|||percentage of participants|||Number
1442802|NCT00913627|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR)|"TOTPAR based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief). For time-weighted sum of pain relief scores from 0 to 4 hours (TOTPAR 0-4), from 4 to 8 hours (TOTPAR 4-8), and from 8 to 12 hours (TOTPAR 8-12): range of scores 0 (worst) to 16 (best). TOTPAR 0-12 range of scores 0 (worst) to 48 (best)."|0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
1442803|NCT00913627|Secondary|Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID)|Time-weighted sum of PRID score where PRID=PID+PR. PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline, ranged from -1 to 3. Baseline pain intensity score of at least 2 required for enrollment. Higher positive PID values = improvement. PR: 5-point categorical pain relief scale None (0), A Little (1), Some (2), A Lot (3) or Complete (4). SPRID 0-4, SPRID 4-8, and SRID 8-12 scores ranged from -4 to 28, SPRID 0-12 ranged from -12 to 84, higher scores = greater improvement.|0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours|ITT population|||units on a scale||Standard Deviation|Mean
1442804|NCT00913627|Secondary|Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8)|"Time-weighted sum of PID score. PID based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity)."|0 to 4 hours and 4 to 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
1442805|NCT00913627|Secondary|Percentage of Participants With Treatment Failure|Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy.|8, 9, 10, 11, and 12 hours|ITT population|||percentage of participants|||Number
1442806|NCT00913627|Secondary|Time to Treatment Failure|Time to first rescue medication or discontinuation due to lack of efficacy|Baseline to 24 hours|ITT population|||hours||95% Confidence Interval|Median
1442807|NCT00913627|Secondary|Time to First Perceptible Pain Relief|Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled “first perceptible relief”, if the participant also depressed the second stopwatch labelled as “meaningful relief” by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she has currently.|Baseline to 6 hours|ITT population|||minutes||95% Confidence Interval|Median
1442808|NCT00913627|Primary|Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)|"PID score based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity)."|8 to 12 hours post dose|ITT population|||units on a scale||Standard Deviation|Mean
1442809|NCT00913627|Primary|Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)|"Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity)."|Baseline (0 hour) to 12 hours post dose|Intent-To-Treat (ITT) population: randomized participants who dosed with study product and provided a baseline pain severity assessment.|||units on a scale||Standard Deviation|Mean
1442810|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
1442811|NCT00913523|Secondary|Changes in Nugent Score|Percentage of subjects who showed a change in Nugent score from a score of </= 3 to a score of >/= 4.|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
1442812|NCT00913523|Secondary|Abundance of Selected Microflora in Tampons|Abundance of selected relevant microorganisms in tampons during menses, in log10 colony forming units (CFU) per gram of menstrual fluid add-on to the tampon, in subjects who had detectable counts of the microorganism.|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||CFU/gm||Standard Deviation|Mean
1442813|NCT00913523|Secondary|Percentage of Subjects With Selected Microflora in Tampons|Percentage of subjects with selected relevant microorganisms in tampons during menses|During Menses|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
1442814|NCT00913523|Secondary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Post-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
1442855|NCT00913380|Secondary|Visualization of the Normal Appendix|Grade 0. Not identified Grade 1. Unsure or partly visualized Grade 2. Clearly and entirely visualized|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
1442815|NCT00913523|Primary|Percentage of Subjects Showing Unfavorable Changes in Primary Microflora|Percentage of subjects showing unfavorable changes of at least 1-log in lactobacilli (decrease), C. albicans (increase), or G. vaginalis (increase)|Mid-Cycle Baseline to Mid-Menstrual Samples|Microbiological analyses are for the “per protocol” population, and no data imputation was performed. Analysis was limited to those subjects whose samples were viable for culture upon receipt at the laboratory.|||Percentage of Participants|||Number
1442816|NCT00913510|Primary|Percent Change From Baseline in Frequency of Micturition Per Day at 8 Weeks.|Number of micturitions per day was assessed using a patient diary during three days at baseline and after 8 weeks of treatment. The relative change in mean number of micturitions was compared between the groups. The change was calculated as percent change = ((measure at 8 weeks - measure at baseline)/measure at baseline)*100%.|Baseline and 8 weeks after randomization.||||percent change||Standard Deviation|Mean
1442817|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1442818|NCT00913458|Secondary|WPAI Questionnaire: Percent Activity Impairment in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
1442819|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1442820|NCT00913458|Secondary|WPAI Questionnaire: Percent Overall Work Impairment in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||units on a scale||Standard Deviation|Mean
1442821|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1442822|NCT00913458|Secondary|WPAI Questionnaire: Percent Impairment While Working in the Past 7 Days Due to Problem|WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named “Percent impairment While Working”) and as such range from 0 to 100.|52 Weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||units on a scale||Standard Deviation|Mean
1442857|NCT00913380|Other Pre-specified|Estimate of Carcinogenic Risk Induced by CT Radiation|Age- and sex-specific carcinogenic risk induced by CT radiation. This is not an actual measurement but an estimate of the stochastic risk, based on assumption and calculation from radiation dose used.|1 day after CT|||||||
1442823|NCT00913458|Secondary|Change From Baseline in WPAI Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI is a 6 question participant rated questionnaire determined the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores = greater impairment and less productivity. The raw (0-10) scores were converted to percent (the variable is named Percent impairment While Working) and as such range from 0 to 100."|64, 76, 91 weeks and Final on Therapy (includes all visits for a participant upto Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Error|Least Squares Mean
1442824|NCT00913458|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed in the Past 7 Days Due to Problem|"WPAI: 6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw (0-10) scores are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||units on a scale||Standard Deviation|Mean
1442825|NCT00913458|Secondary|Change From Baseline mTSS at Week 91 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)||||Units on a scale||Standard Error|Least Squares Mean
1442826|NCT00913458|Secondary|Modified Total Sharp Score (mTSS) at Week 52|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
1442827|NCT00913458|Secondary|Number of Participants Achieving Patient Acceptable Symptom State (PASS)|The PASS is defined as a symptom state that the subjects consider acceptable.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
1442828|NCT00913458|Secondary|Participant's Global Assessment of Pain (Visual Analogue Scale) (VAS)|100-mm line (Visual Analog Scale) marked by the participant to measure their degree of pain over past 2-3 weeks. Range: 0 = no pain to 100 = pain as bad as it could be.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||mm||Standard Deviation|Mean
1442829|NCT00913458|Secondary|Participant's Global Assessment of Disease Activity|Participant’s Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
1442830|NCT00913458|Secondary|Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Units on a scale||Standard Deviation|Mean
1442831|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on a 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 2 was defined as:~DAS28 <2.6 at the Week 76 and Week 91 visits and~No radiographic progression during Phase 2, defined as mean change from Week 52 in mTSS of ≤0.5.~Participant must achieve HAQ score ≤0.5 at Week 76 and 91 visits. HAQ is self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.A subject had to satisfy all 3 criteria at thevisits to be defined as a responder"|52 and 91 weeks|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
1442970|NCT00912223|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die, or if they relapse/progress or receive anti-lymphoma therapy not including planned post-transplant radiation.|Year 2||||percentage of participants||95% Confidence Interval|Number
1442832|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
1442833|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
1442834|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
1442835|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
1442836|NCT00913458|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
1442837|NCT00913458|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|52, 56, 64, 76, 91 weeks and Final on Therapy (includes all visits for a participant up to Week 91 or the visit they discontinued at)|Modified intent-to-treat (mITT) population, which included all subjects who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||participants|||Number
1442838|NCT00913458|Secondary|Proportion of Subjects Achieving a Patient Acceptable Symptom State (PASS) at Each Visit|The PASS is defined as a symptom state that the participants consider acceptable.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
1442839|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44) - Low Disease Activity|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participant who took at least 1 dose of open-label investigational product|||participants|||Number
1442858|NCT00913380|Other Pre-specified|Radiation Dose|"Radiation dose is measured in terms of dose-length product (mGy•cm) as displayed in the CT console. The length indicates the scan range."|1 day after CT|All participants who underwent CT. Intention to treat. Complete case analysis.|||mGy•cm||Inter-Quartile Range|Median
1442969|NCT00912223|Secondary|Graft Failure|Primary graft failure is defined as a donor peripheral blood T cell chimerism < 5% at Day +30 post-transplant. Secondary Graft Failure is defined as documented engraftment followed by loss of graft as defined by donor peripheral blood T cell chimerism < 5%.|Day 30||||participants|||Number
1442840|NCT00913458|Secondary|Number of Participants With Disease Activity Score Based on 44-joints Count (DAS44)-Remission|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
1442841|NCT00913458|Secondary|Change From Baseline in DAS44 Score at All Visits|DAS44 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 44 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS44 <1.6 = clinical remission, DAS44 ≤2.4 = low disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
1442842|NCT00913458|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|Participant’s Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 = extreme disease activity|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
1442843|NCT00913458|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 Visual Analog Scale (VAS), with 0 = no disease activity and 100 = extreme disease activity.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Units on a scale||Standard Deviation|Mean
1442844|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 90% (ACR 90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
1442845|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 70% (ACR 70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
1442846|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 50% (ACR 50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
1442847|NCT00913458|Secondary|Number of Participants Achieving American College of Rhematology 20% (ACR 20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.|2, 4, 8, 13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
1442856|NCT00913380|Secondary|Diagnosis of Appendiceal Perforation in CT in Patients With Confirmed Appendicitis.|"True positive: Perforation was rated as present in CT report and confirmed as present.~False positive: Perforation was rated as present in CT report and confirmed as absent.~True negative: Perforation was rated as absent in CT report and confirmed as absent.~False negative: Perforation was rated as absent in CT report and confirmed as present.~The data are used to calculate sensitivity and specificity."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
1442876|NCT00913003|Primary|24 Hour Hydromorphone|Total IV hydromorphone administered during surgery to 24 hours post surgery|24 hour||||miligrams||Standard Deviation|Mean
1442848|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Activity Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
1442849|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
1442850|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
1442851|NCT00913458|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem|"WPAI:6 question participant rated questionnaire to determine the degree to which rheumatoid arthritis affected work productivity while at work and affected activities outside of work. Four scores are derived:percentage of absenteeism, percentage of presenteeism (reduced productivity while at work),overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. The raw scores (0-10) are converted to percents (the variable is named Percent impairment While Working) and as such range from 0 to 100."|13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||units on a scale||Standard Deviation|Mean
1442852|NCT00913458|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Units on a scale||Standard Deviation|Mean
1442853|NCT00913458|Secondary|Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)|"The composite measure of complete response over the last 3 months of Phase 1 was defined as:~DAS28 <2.6 at the week 39 and 52 visits and,~No radiographic progression during Phase 1, defined as mean change in modified total Sharp score (mTSS) ≤0.5 and,~Health Assessment Questionnaire (HAQ) ≤ 0.5 at the week 39 and week 52 visits"|End of Phase 1|Efficacy data were analyzed in the modified intent-to-treat (mITT) population, which included all participants who took at least 1 dose of open-label investigational product|||Participants|||Number
1442854|NCT00913458|Primary|Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score|"Sustained remission was defined as a DAS28 <2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 >3.2 at either the Week 56 or Week 64 visit.~DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity.~The participants who met sustained remission in both Week 76 and 91 are presented here."|76 and 91 weeks|Modified intent-to-treat (mITT) population, which included all participants who had taken at least 1 dose of double-blind investigational product and had at least 1 post-randomization DAS28 evaluation.|||Participants|||Number
1442877|NCT00913003|Secondary|Number of Participants Experiencing Post Operative Ileus||7 days||||Participants|||Number
1442859|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Not Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.~Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data are used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed not to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
1442860|NCT00913380|Secondary|Likelihood of Appendicitis in CT Report in Patients Confirmed as Having Appendicitis|"Grade 1. Definitely absent. Clinical observation is recommended. Grade 2. Probably absent. Clinical observation is recommended. Grade 3. Indeterminate. Clinical observation or surgical exploration is recommended.~Grade 4. Probably present. Surgical exploration is recommended. Grade 5. Definitely present. Surgical exploration is recommended. The data is used to calculate sensitivity, specificity, area under receiver-operating-curve and to measure diagnostic confidence."|3 months after CT|"Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.~There can be missing data if CT report was not made following predefined structured format."|||participants|||Number
1442861|NCT00913380|Secondary|Interval From CT to Discharge After Appendectomy|Time interval between the CT acquisition and discharge after appendectomy|3 months after CT|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.|||day||Inter-Quartile Range|Median
1442862|NCT00913380|Secondary|Interval Between CT and Discharge Without Surgery|Time interval between the CT acquisition and discharge without surgery|3 months after CT|Participants who did not undergo surgery. Intention to treat. Complete case analysis.|||hr||Inter-Quartile Range|Median
1442863|NCT00913380|Secondary|Interval Between CT and Appendectomy|Time interval between the CT acquisition and non-incidental appendectomy|1 day after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.|||hr||Inter-Quartile Range|Median
1442864|NCT00913380|Secondary|Appendiceal Perforation|Number of participants with appendiceal perforation|1 week after surgery|Participants confirmed to have appendicitis. Intention to treat. Complete case analysis.|||participants|||Number
1442865|NCT00913380|Secondary|Additional Imaging Test(s)|Number of participants who need additional imaging test(s) to diagnose or rule out appendicitis|1 week after CT|All participants included in outcome analyses. Intention to treat. Complete case analysis.|||participants|||Number
1442866|NCT00913380|Primary|Negative Appendectomy|Number of participants with unnecessary appendectomies (removal of un-inflamed appendix)|1 week after surgery|Participants who underwent non-incidental appendectomy. Intention to treat. Complete case analysis.|||participants|||Number
1442867|NCT00913263|Secondary|Number of Days to Prostate Volume Nadir.|Number of Days from day of injection to prostate volume nadir.|Measured every 4th week until progression or maximum 6 months.||||Days||95% Confidence Interval|Median
1442868|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Final Visit|Prostate volume was captured at each visit and percent change from baseline to final visit was measured. Final visit was either day of progression or after 6 months. Prostate volume decrease is reported in percent change from baseline|Measured every 4th week until progresion or maximum 6 months.||||percentage change||Standard Deviation|Median
1442869|NCT00913263|Secondary|Time to PSA Nadir|Time frame was from baseline to day of PSA nadir.|Measured every 4th week until progression or maximum 6 moths.||||Number of days from baseline to PSA nadi||95% Confidence Interval|Number
1442870|NCT00913263|Secondary|Percent Change in Prostate Volume From Baseline to Nadir.|Prostate volume was measured at each visit to capture nadir and compared to baseline for all patients. Decrease in prostate volume is reported as percent change from baseline.|Measured every 4th week until progression or maximum 6 months.||||percent change||Standard Deviation|Median
1442871|NCT00913263|Secondary|Number of Patients Reporting Adverse Events Caused by the Study Treatment|"Adverse events caused by the study treatment~Abnormal, clinically relevant, laboratory parameters~Voiding symptoms~Vital Signs~Quality of Life"|Measured every 4th week till progression or maximum 6 months|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, should be included in the efficacy analysis.~Study population safety All patients who received at least one dose of Liproca® Depot should be included in the safety analysis."|||Patients reporting study related AE|||Number
1442872|NCT00913263|Primary|Proportion of Patients Showing PSA Nadir|Plasma PSA nadir is the lowest PSA reading achieved after any treatment for prostate cancer. The patients were observed once every 4th week during the study period.|Measured every 4th week until progression or maximum 6 months.|"All patients who received the single dose of Liproca® Depot and had a baseline plasma PSA measurement, and at least one PSA measurement after the baseline measurement, were included in the efficacy analysis.~Study population safety All patients who received at least one dose of Liproca® Depot were included in the safety analysis."|||percentage of patients with PSA nadir||95% Confidence Interval|Number
1442873|NCT00913133|Secondary|Thrombosis|"New onset symptomatic thrombosis requiring medical or surgical intervention;~Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction."|Up until 24 hours after last dose of study drug|Patients who received at least one dose of study drug|||participants|||Number
1442874|NCT00913133|Primary|Major Bleeding|Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.|24 hours after last dose of study drug|All patients receiving at least one dose of study drug|||participants|||Number
1442875|NCT00913081|Primary|Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin|Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.|8 hour period|All subjects who finished at least one visit were analysed.|||Fold change over baseline||95% Confidence Interval|Mean
1442879|NCT00912964|Secondary|Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a one point improvement from Baseline to post-baseline and a major improvement was defined as at least a two point improvement from Baseline to post-baseline in PPBC score.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percentage of participants|||Number
1442880|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Overall Condition on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in the patient's overall condition since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.|||participants|||Number
1442881|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Patient Global Impression Scale|The patient global impression (PGI) scale assessed the change in bladder symptoms since the start of the study and was completed by the patient at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.|||participants|||Number
1442882|NCT00912964|Secondary|Summary of Baseline, Week 12 and Final Visit Change in Bladder Symptoms on the Clinician Global Impression Scale|The Clinician Global Impression Scale (CGI) assessed the change in the patient's bladder symptoms since the start of the study and was completed by the physician at Baseline and at Week 12/end of treatment. The degree of change was categorized as one of the following: 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse', or 'Very much worse'.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. This assessment was completed by English speaking patients in the United States only. LOCF was used for the Final visit analysis.|||participants|||Number
1442883|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician|The number of times the patient visited a physician’s office during the 4 weeks prior to each study visit (excluding study visits) because of the patient’s bladder condition.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||Physician visits||Standard Deviation|Mean
1442884|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A positive change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Error|Least Squares Mean
1442885|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems’; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. LS means are from an ANCOVA model with treatment group, gender, and geographical regions as fixed factors and baseline as a covariate. A negative change from Baseline score indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants included at each time point (N) only includes those with baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Error|Least Squares Mean
1442886|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) includes only patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||scores on a scale||Standard Deviation|Mean
1442887|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1442888|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1442889|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available at that Visit.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1442890|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-Care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself. In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1442891|NCT00912964|Secondary|Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by Final Visit health status and reports the number of patients in that category. Missing data indicates patients with no data available for that Visit."|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||participants|||Number
1442892|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with daily activities over the last 7 days. Percent activity impairment is derived from the patient’s assessment of the degree to which OAB affected their regular daily activities. A higher percentage indicates greater impairment. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. The number of participants at each time point (N) included patients with both baseline and post-baseline values. LOCF was used for the Final Visit analysis.|||percent activity impairment||Standard Deviation|Mean
1442893|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent overall work impairment takes into account both hours missed due to OAB symptoms and the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent overall work impairment||Standard Deviation|Mean
1442934|NCT00912743|Secondary|Overall Survival|Overall survival is defined as the duration from first dose till death from any cause. In absence of death, the time is calculated from first dose till the date subject last known to be alive|Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months|Full analysis set - all treated patients|||days||95% Confidence Interval|Median
1442894|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent impairment while working was derived from the patient’s assessment of the degree to which OAB affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent impairment while working||Standard Deviation|Mean
1442895|NCT00912964|Secondary|Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess the degree and extent to which overactive bladder (OAB) symptoms interfered with work productivity in the last 7 days. Percent of work time missed is derived from the number of hours of work missed due to OAB symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from baseline indicates improvement.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. The number of patients at each time point (N) includes those with both baseline and post-baseline values who were employed. LOCF was used for the Final Visit analysis.|||percent work time missed||Standard Deviation|Mean
1442896|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score|"Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||scores on a scale||Standard Error|Least Squares Mean
1442897|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score|"Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|"The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for the Final Visit analysis. The number of participants included in the calculation for each time point is noted as N."|||scores on a scale||Standard Error|Least Squares Mean
1442898|NCT00912964|Secondary|Percentage of Responders for Number of Grade 3 or 4 Urgency Episodes|Percentage of participants with a decrease from baseline to final visit in mean number of urgency episodes (grade 3 or 4) at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 1.54 for mean number of urgency episodes (grade 3 or 4). The mean number of urgency episodes was derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale where a score 3=severe urgency and 4=urge incontinence.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||percentage of participants|||Number
1442899|NCT00912964|Secondary|Percentage of Responders for Mean Level of Urgency|Percentage of participants with a decrease from Baseline to Final Visit in mean level of urgency at least as large as the pre-specified minimally important difference (MID). The MID was determined to be 0.24 for mean level of urgency. Mean level of urgency was derived from the average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale which ranged from 0 (No urgency) to 4 (Urge incontinence).|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary. LOCF was used for this analysis.|||percentage of participants|||Number
1442900|NCT00912964|Secondary|Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with at least a 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the patient micturition diary.|Baseline and Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
1442901|NCT00912964|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the patient.|Weeks 4, 8 and 12|The full analysis set-incontinence included all patients who took at least 1 dose of double-blind study drug & had a baseline & at least 1 postbaseline micturition measurement in the visit diary & who had at least 1 incontinence episode at baseline. LOCF was used for the Final Visit analysis. N is the number of patients included at each time point.|||percentage of participants|||Number
1442902|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours|"The average number of times a patient records a new pad used per day during the 3-day micturition diary period.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 postbaseline micturition measurement in the visit diary and who had at least one use of a pad at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||pads||Standard Error|Least Squares Mean
1442903|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours|"Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day patient micturition diary.~LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate."|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least one nocturia episode at baseline. LOCF was used for the Final Visit analysis. N is the number of participants included at each time point.|||nocturia episodes||Standard Error|Least Squares Mean
1442904|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized for this analysis. The number of participants included in the calculation for each time point is noted as N."|||scores on a scale||Standard Error|Least Squares Mean
1442905|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. LOCF was not utilized for this analysis. N is the number of patients included at each time point.|||Urgency episodes||Standard Error|Least Squares Mean
1442906|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode (grade 3 or 4) at baseline. LOCF was not utilized.|||Urgency incontinence episodes||Standard Error|Least Squares Mean
1442907|NCT00912964|Secondary|Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 4, 8 and 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 4, 8 and 12|"The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. LOCF was not utilized in this analysis. The number of participants included in the calculation for each time point is noted as N."|||mL||Standard Error|Least Squares Mean
1442908|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set-incontinence included all randomized patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 incontinence episode at baseline. The number of patients included at each time point is noted as “N”. LOCF was not utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
1442935|NCT00912743|Secondary|Progression Free Survival|Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients|||days||95% Confidence Interval|Median
1442971|NCT00912158|Primary|Number of Patients Who Were Intubated|Number of patients who were subjected to endotracheal intubation and invasive mechanical ventilation|During ICU Stay||||participants|||Number
1442909|NCT00912964|Secondary|Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline, Week 8 and 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Weeks 8 and 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. The number of patients included in the calculation for each time point is noted as “N”. LOCF was not used in this analysis.|||micturitions||Standard Error|Least Squares Mean
1442910|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the patient in a 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all patients who took at least 1 dose of double-blind study drug and had a baseline and at least 1 post baseline micturition measurement in the visit diary and at least 1 episode of urgency grade 3 or 4 at baseline. Last observation carried forward was utilized.|||urgency episodes||Standard Error|Least Squares Mean
1442911|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The involuntary leakage of urine accompanied by or immediately proceeded by urgency, derived from the number of incontinence episodes classified by the patient in a 3-day micturition diary as 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 urgency incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.|||urgency incontinence episodes||Standard Error|Least Squares Mean
1442912|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Level of Urgency|Average of patients’ ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in a 3-day micturition diary according to the following 5-point categorical scale (Patient Perception of Intensity of Urgency Scale): 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet. LS Means are from an ANCOVA with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||scores on a scale||Standard Error|Least Squares Mean
1442913|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was calculated from the number of micturitions recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was not utilized in this analysis.|||micturitions||Standard Error|Least Squares Mean
1442914|NCT00912964|Secondary|Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per 24 hours was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 4 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 4|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was not utilized in this analysis.|||Incontinence episodes||Standard Error|Least Squares Mean
1442915|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||micturitions||Standard Error|Least Squares Mean
1442916|NCT00912964|Secondary|Change From Baseline to End of Treatment (Final Visit) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the patient and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits. LS Means were generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary. Last observation carried forward was utilized.|||mL||Standard Error|Least Squares Mean
1442967|NCT00912223|Secondary|Time to Neutrophil Recovery|Neutrophil Recovery is defined as ANC > 500/mm^3 for 3 consecutive days.|Day 60||||days||Full Range|Median
1442917|NCT00912964|Primary|Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|Baseline and Week 12|The full analysis set-Incontinence included all randomized patients who took at least 1 dose of double-blind study drug and who had a baseline and at least 1 post baseline micturition measurement in the visit diary and who had at least 1 incontinence episode at baseline. Last observation carried forward (LOCF) was utilized.|||Incontinence episodes||Standard Error|Least Squares Mean
1442918|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Urinary Glycosaminoglycan (GAG) Levels|Urinary Glycosaminoglycan (GAG) Levels: Concentration of GAG relative to creatinine in urine. A greater decrease in GAG level indicates a greater response.|Baseline to Week 26||||ug/mg||Standard Deviation|Mean
1442919|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Active Joint Range of Motion (ROM)|Active Joint Range of Motion (ROM): Shoulder Flexion Ability to maximally raise one's arm overhead without assistance. Shoulder range of motion (mean of left and right arms) measured in degrees (0-180) by goniometry. Greater degree of flexion indicates greater response.|Baseline to Week 26||||Degrees||Standard Deviation|Mean
1442920|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Child Health Assessment Questionnaire/Health Assessment Questionnaire (CHAQ/HAQ) Disability Index Score|CHAQ/HAQ) = Patient questionnaire that measures the degree of disability on a scale of 0 (no disability) to 3 (maximal disability). A lower score indicates a greater response.|Baseline to week 26||||Units on a scale||Standard Deviation|Mean
1442921|NCT00912925|Secondary|Overall Percent Change From Baseline to Week 26 in Liver Volume|Liver Organ Volume: Volume of liver measured by Magnetic Resonance Imaging (MRI). Greater decrease in volume indicates a greater response.|Baseline to Week 26||||Cubic centimeters||Standard Deviation|Mean
1442922|NCT00912925|Secondary|Overall Change From Baseline to Week 26 in Apnea/Hypopnea Index (AHI)|Apnea/Hypopnea Index (AHI): Number of absent (apnea) and shallow (hypopnea) breaths per hour of sleep. Overall change from Baseline to Week 26 in AHI. A greater decrease in events indicates a greater response.|Baseline to Week 26||||Events per hour||Standard Deviation|Mean
1442923|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Six Minute Walk Test (6MWT)|Six Minute Walk Test (6MWT): Distance walked (measured in meters) in 6 minutes. A longer distance indicates a greater response.|Baseline to Week 26||||meters||Standard Deviation|Mean
1442924|NCT00912925|Primary|Overall Change From Baseline to Week 26 in Percent Predicted Forced Vital Capacity (FVC)|Percent Predicted Forced Vital Capacity (FVC): the maximal exhaled breathe volume following a maximal inhaled breath. Overall Change from Baseline to Week 26 in percent predicted FVC = (observed value)/(predicted value) * 100%). A higher value indicates a greater response.|Baseline to Week 26||||Percent predicted FVC||Standard Deviation|Mean
1442925|NCT00912912|Primary|12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate|Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.|12 weeks||||Percentage of Participants|||Number
1442926|NCT00912808|Secondary|Frequency of Near Falls Per Day|The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.|6 weeks||||Number Near Falls/Day||Standard Error|Mean
1442927|NCT00912808|Primary|Fall Frequency Per Day|The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.|6 weeks||||Number Falls/Day||Standard Error|Mean
1442928|NCT00912795|Secondary|Self-reported 30-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 30 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
1442929|NCT00912795|Secondary|Self-reported 7-day Point Prevalence Abstinence at 12 Weeks|self-reported smoking abstinence in the past 7 days at 12 weeks (<=5 cigarettes)|12 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
1442930|NCT00912795|Secondary|CO-verified 7-day Point Prevalence Abstinence at 4 Weeks|self-reported continuous abstinence in the past 7 days at 4 weeks (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|4 weeks|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
1442931|NCT00912795|Primary|Carbon Monoxide-verified Continuous Abstinence at 12 Weeks|self-reported continuous abstinence since quit day (<=5 cigarettes) verified with carbon monoxide reading (<=8ppm)|12-weeks post-quit day|Intention-to-treat (ITT) analysis: All participants randomized at baseline included in analyses regardless of completion of 12-week follow-up data. Missing equals failure (i.e., smoked cigarettes).|||participants|||Number
1442932|NCT00912782|Secondary|25-hydroxyvitamin D and Serum Calcium||10 weeks||||ng/mL||Standard Deviation|Mean
1442933|NCT00912782|Primary|Arteriovenous Fistulae Maturation|Maturation of an AVF is the ability to stick the AVF with two large bore needles at ≥ 6 consecutive dialysis sessions, and achievement of an AVF blood flow >300 ml/min, assessed at six months following AVF creation.|6 months||||percentage of group|||Number
1442936|NCT00912743|Primary|Tumour Response|Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)|From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months|Full analysis set - all treated patients|||Percentage of Participants||95% Confidence Interval|Number
1442937|NCT00912509|Secondary|Time to Resolution of Stromal Infiltration||day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved||||days||Inter-Quartile Range|Median
1442938|NCT00912509|Primary|Time to Re-epithelialization||Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete||||Days||Inter-Quartile Range|Median
1442939|NCT00912405|Secondary|Number of Sinuses With Significant Post-operative Adhesion Formation|Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.|30 days||||sinuses|Participants||Number
1442940|NCT00912405|Secondary|Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities|Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.|Baseline and 30 days||||Pts. w/ significant IOP elevation|||Number
1442941|NCT00912405|Primary|Device Placement Success Rate|A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.|At the time of procedure||||Sinuses|Participants||Number
1442942|NCT00912405|Primary|Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)||30 days||||Number of Sinuses|Participants|95% Confidence Interval|Number
1442943|NCT00912301|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|after 4 days' treatment||||percentage of the radio-labeled meal||Standard Deviation|Mean
1442944|NCT00912301|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|after 4 days' treatment||||units on a scale||Standard Deviation|Mean
1442945|NCT00912301|Secondary|Ascending Colon Emptying (AC t_1/2)||after 4 days' treatment||||hours||Standard Deviation|Mean
1442946|NCT00912301|Secondary|Colonic Transit at 48 Hours (GC48)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment||||units on a scale||Standard Deviation|Mean
1442947|NCT00912301|Primary|Colonic Geometric Center at 24 Hours (GC24)|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|after 4 days of treatment||||units on a scale||Standard Deviation|Mean
1442948|NCT00912288|Secondary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence (including clinially important changes in clinical safety laboratory assessments, electrocardiograms and vital signs) in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Safety analysis set included all participants who received at least 1 dose of study medication, including partial doses.|||Participants|||Number
1442949|NCT00912288|Secondary|Population Pharmacokinetic (PK) Analysis|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12|||||||
1442950|NCT00912288|Secondary|Euro Quality of Life - 5 Domain (EQ-5D) Assessment|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Total possible score ranged from 5 to 15; lower score indicated a better health state.|Baseline, Weeks 12, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442951|NCT00912288|Secondary|Resource Utilization in Dementia-Lite Version (RUD-Lite)|RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver’s job. Overall cost of care was evaluated to quantify resources utilized.|Baseline, Weeks 12, 18, 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442968|NCT00912223|Secondary|Donor Cell Engraftment|Donor engraftment is defined as > 5% donor peripheral blood T cell chimerism by Day +30 post-transplant in the setting of Absolute Neutrophil Count (ANC) recovery (ANC >500/mm^3 for 3 consecutive days).|Days 30 and 100||||percentage of donor T-cell chimerism||Full Range|Median
1442952|NCT00912288|Secondary|Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores|Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) version of CIBIC-Plus was used to assess participant’s overall disease severity. The corresponding baseline assessment rated participant on 7-point scale: (1) extremely severe AD to (7) no symptoms of AD. Overall impression of change from baseline was rated on a 7-point scale: 1=marked improvement; 2=moderate improvement; 3=minimal improvement; 4=no change; 5=minimal worsening; 6=moderate worsening; 7=marked worsening; all assessments are relative to baseline. Higher score = worsening of global function.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442953|NCT00912288|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26|MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442954|NCT00912288|Secondary|Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI|NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer’s Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.|Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442955|NCT00912288|Secondary|Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26|NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442956|NCT00912288|Primary|Change From Baseline in the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26|ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442957|NCT00912288|Primary|Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26|SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis(0-8), visuospatial ability(0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score = greater cognitive impairment.|Baseline, Week 26|Data for this outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to early termination of the study.||||||
1442958|NCT00912223|Secondary|Serum Rituximab (RTX) Levels|RTX concentration levels within participants|Baseline, Days 28 and 365|Serum RTX concentrations were collected at baseline (n=57), day +28 (n=56), and day +365 (n=44) for a compliance rate of 92%, 90%, and 80% at the assigned time points.|||ng/mL||Full Range|Median
1442959|NCT00912223|Secondary|Incidence of Toxicities|Number of participants that experiences at least one grade 3 - 5 toxicity during the first two years, where grade 5 is worst. Toxicity grades are based on the NCI CTCAE Version 3.0.|Year 2||||participants|||Number
1442960|NCT00912223|Secondary|Immunologic Reconstitution|Quantitative immunoglobulins (IgG)|Year 1||||mg/dL||Full Range|Median
1442961|NCT00912223|Secondary|Quality of Life||Year 2|No data collected||||||
1442962|NCT00912223|Secondary|Infections||Year 2|no data collected||||||
1442963|NCT00912223|Secondary|Treatment-related Mortality (TRM)|The event is death occurring in patients in continuous complete remission. The TRM distribution will be estimated by the Kaplan-Meier curve.|Year 3||||percentage of participants||95% Confidence Interval|Number
1442964|NCT00912223|Secondary|Overall Survival|The event is death from any cause.|Years 2 and 3||||percentage of participants||95% Confidence Interval|Number
1442965|NCT00912223|Secondary|Chronic GVHD|The event is the incidence and severity of chronic GVHD from day of transplant, a cumulative incidence curve will be computed along with a 95% confidence interval at two years post-transplant. Death prior to occurrence of chronic GVHD will be considered as a competing risk.|Year 2||||percentage of participants||95% Confidence Interval|Number
1442966|NCT00912223|Secondary|Acute Graft-versus-Host Disease (GVHD)|The event is the incidence of grades II-IV acute GVHD from day of transplant, where grade IV is worst. The first day of acute GVHD onset at a certain grade will be used to calculate a cumulative incidence curve for that acute GVHD grade. GVHD should be monitored in accordance with BMT CTN manual of procedures guidelines. Acute GVHD grading was based on the consensus conference criteria (Przepiorka, et. al., 1994) and the Center for International Blood and Marrow Transplant Research (CIBMTR) grading criteria.|Day 100||||percentage of participants||95% Confidence Interval|Number
1442973|NCT00912093|Secondary|Time to Investigator-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
1442974|NCT00912093|Secondary|Time to Subject-Assessed Initial Symptom Improvement|Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
1442975|NCT00912093|Secondary|Time to Almost Complete Symptom Relief|Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores <10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time.|Up to 120 Hours post treatment|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
1442976|NCT00912093|Secondary|Time to Onset of Primary Symptom Relief|Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
1442977|NCT00912093|Primary|Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient|Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.|Up to 120 hours post-dose|Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy.|||Hours||95% Confidence Interval|Median
1442978|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
1442979|NCT00912028|Primary|Corneal Staining|Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis was on those subjects who were enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
1442980|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those who are enrolled, randomized to a study arm, and completed the study.|||eyes|eyes||Number
1442981|NCT00912028|Primary|Bulbar Hyperemia (Redness)|Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks||||eyes|eyes||Number
1442982|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|4 weeks|Analysis is on those subjects who are enrolled, randomized to a study arm, and who completed the study.|||eyes|eyes||Number
1442983|NCT00912028|Primary|Limbal Hyperemia (Redness)|Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.|2 weeks|Analysis is on those subjects who were enrolled, randomized, and completed the study.|||eyes|eyes||Number
1442984|NCT00912015|Primary|Adverse Events: 12-months Safety Population|Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.|12 months|Patients who received the same dose for at least 350 days (12 months)|||participants|||Number
1442985|NCT00912002|Secondary|Number of Participants Who Discontinued the Study Due to An Adverse Event||Up to 14 days after study drug administration|All treated participants.|||participants|||Number
1442987|NCT00912002|Primary|Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).|Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.|Up to 168 hours after study drug administration|All treated participants.|||Percent Recovered||Standard Deviation|Mean
1442988|NCT00911989|Primary|Proportion of Procedures Completed With Successful Endoscopic Visualization.|The goal of the study was to evaluate the feasibility of endoscopic visualization during a laparoscopic sleeve gastrectomy procedure using an endoscope inserted transvaginally through a steerable flex trocar. The number of subjects in whom the procedure was completed with endoscopic visualization was recorded.|Assessed intra-operatively|All subjects on whom the surgery was attempted represent the primary analysis population.|||participants|||Number
1442989|NCT00911937|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1442990|NCT00911937|Secondary|Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)|OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1442991|NCT00911937|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline, Week 4 and 12|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Least Squares Mean
1442992|NCT00911937|Secondary|Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score – lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1442993|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Micturition at Week 12|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||mL||Standard Error|Least Squares Mean
1442994|NCT00911937|Secondary|Mean Voided Volume Per Micturition|Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||mL||Standard Deviation|Mean
1442995|NCT00911937|Secondary|Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline and Week 12|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||mL||Standard Error|Least Squares Mean
1442996|NCT00911937|Secondary|Mean Voided Volume Per Nocturnal Micturition|Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline voided volume per nocturnal micturition greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||milliliter (mL)||Standard Deviation|Mean
1442997|NCT00911937|Secondary|Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Least Squares Mean
1442998|NCT00911937|Secondary|Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1442999|NCT00911937|Secondary|Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Error|Least Squares Mean
1443000|NCT00911937|Secondary|Nocturnal Frequency-urgency Sum Rating Per 24 Hours|Frequency-urgency sum is total USS ratings recorded for all nocturnal micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal frequency-urgency sum rating greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||units on a scale||Standard Deviation|Mean
1443001|NCT00911937|Secondary|Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1443002|NCT00911937|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
1443003|NCT00911937|Secondary|Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours|UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline UUI episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
1443004|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1443005|NCT00911937|Secondary|Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
1443006|NCT00911937|Secondary|Number of Micturition-related Urgency Episodes Per 24 Hours|The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
1443007|NCT00911937|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12|Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1443008|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Error|Least Squares Mean
1443009|NCT00911937|Secondary|Mean Number of Micturitions Per 24 Hours|Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [UUI]. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.|Baseline|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Deviation|Mean
1443010|NCT00911937|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Percent change of nocturnal micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1443011|NCT00911937|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Error|Least Squares Mean
1443012|NCT00911937|Secondary|Number of Nocturnal Micturitions Per 24 Hours|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.|Baseline|FAS population. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal micturition frequency greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||micturitions per 24 hours||Standard Deviation|Mean
1443013|NCT00911937|Secondary|Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12|Percent change of micturition-related nocturnal urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (100*(Week 4 or 12 - baseline)/baseline).|Baseline, Week 4 and 12|FAS population. LOCF method was used to impute only Week 12 missing data but not Week 4 missing data. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||percent change||Standard Deviation|Mean
1443014|NCT00911937|Secondary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of micturition-related nocturnal urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 4|FAS population included all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’ (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 4.|||episodes per 24 hours||Standard Error|Least Squares Mean
1443015|NCT00911937|Primary|Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12|Micturition-related nocturnal urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline and Week 12|FAS population. Last observation carried forward (LOCF) method was used to impute missing data. Here, 'N' (number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Error|Least Squares Mean
1443046|NCT00911768|Secondary|Unstimulated Salivary Flow Rates|Unstimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was changes of unstimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.|||ml/min||Standard Deviation|Mean
1443016|NCT00911937|Primary|Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours|Micturition-related nocturnal urgency episodes had urinary sensation scale (USS) rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.|Baseline|Full analysis set (FAS): all participants who received at least 1 dose of study drug and had at least baseline or a post-baseline efficacy assessment. Here, ‘N’(number of participants analyzed) signifies those participants who had baseline nocturnal urgency episodes greater than 0 per 24 hours and non-missing change from baseline value at Week 12.|||episodes per 24 hours||Standard Deviation|Mean
1443017|NCT00911898|Primary|Maximum Tolerated Dose (MTD) or Maximum Feasible Dose|The Maximum Tolerated Dose (MTD) was defined as the highest dose level in which a DLT is experienced by fewer than two patients in a cohort of 3 - 6 patients. If a DLT is observed in at least two patients in a cohort of 3 – 6 patients, the MTD will be determined to have been exceeded and an additional three patients (up to a total of six) are to be treated at the next lower dose level.|28 days||||mg/kg|||Number
1443018|NCT00911898|Secondary|To Explore the Role Functional Imagining (FDG-PET CT Scan), as a Predictor of Clinical Activity||December 2011|||||||
1443019|NCT00911898|Secondary|To Determine the Clinical Activity of MM-111 in Patients Based on Objective Response Rate (ORR), Duration of Response (DoR), Progression Free Survival (PFS), and 16 & 24-week Clinical Benefit Rate (CBR)||December 2011|||||||
1443020|NCT00911859|Secondary|Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)|"Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) health and quality of life."|Baseline (Day 1 predose) and Cycle 9 (Week 54)|Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9|||Scores on a scale||Standard Deviation|Mean
1443021|NCT00911859|Secondary|Overall Survival|Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.|From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
1443022|NCT00911859|Secondary|1-year Survival Rate|Percentage of participants who are alive at the end of year 1 after randomization|1 year|Intent-to-treat (ITT) population: all randomized participants|||Percentage of participants|||Number
1443023|NCT00911859|Secondary|Duration of Response (DOR)|DOR was defined as length from the earliest date a participant achieved a complete response (CR) or partial response (PR) to either date for disease progression (including relapse from CR) or the censoring date for progressive disease. Responders without disease progression were censored at the last efficacy assessment for disease progression.|From the date participants achieved CR or PR to either date for disease progression (including relapse from CR) or the censoring date for progressive disease, as assessed Up to 30 days after last dose of study medication|Included participants in the randomized population who achieved CR or PR.|||Days||95% Confidence Interval|Median
1443024|NCT00911859|Secondary|1-year Progression-Free Survival (PFS) Rate|The 1-year PFS rate was defined as the percentage of participants surviving 1 year after randomization without disease progression or death.|1 year|Intent-to-treat (ITT) population: all randomized participants|||Percentage of participants|||Number
1443025|NCT00911859|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between randomization and either disease progression or death, whichever occurred first.|From the date of randomization until disease progression or death, whichever occurred first, as assessed up to the last efficacy assessment for disease progression (approximately 3 years)|Intent-to-treat (ITT) population: all randomized participants.|||Days||95% Confidence Interval|Median
1443026|NCT00911859|Secondary|Percentage of Participants Who Achieved Stringent Complete Response (sCR) - International Myeloma Working Group (IMWG) Criteria|sCR was assesses by IMWG Criteria: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, <=5% plasma cells in bone marrow, normal free light chain ratio, absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. sCR is a CR that has been confirmed by immunofixation + free light chain assay + either bone marrow immunohistochemistry or immunofluorescence|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.|||Percentage of participants|||Number
1443027|NCT00911859|Secondary|Percentage of Participants Who Achieved Overall Response ie, Complete Response (CR) or Partial Response (PR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR or PR was assessed using EBMT criteria. CR: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks; PR: >=50% reduction in the level of serum monoclonal paraprotein for at least 2 determinations 6 weeks apart, if present, reduction in 24-hour urinary light chain excretion by either >=90% or to <200 mg for at least 2 determinations 6 weeks apart, >=50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least 6 weeks, if skeletal survey is available: no increase in size or number of lytic bone lesions|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.|||Percentage of participants|||Number
1443028|NCT00911859|Primary|Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria|CR was assessed using EMBT criteria: disappearance of the original monoclonal paraprotein from the blood and urine on at least 2 determinations for a minimum of 6 weeks by immunofixation studies, <5% plasma cells in the bone marrow on at least 1 determination, if skeletal survey is available: no increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response), disappearance of soft tissue plasmacytomas for at least 6 weeks.|Up to disease progression, approximately 3 years|Response-evaluable population: Participants who had a confirmed diagnosis of multiple myeloma and measurable disease according to the EBMT criteria were evaluated for disease response. Also, participants must have received at least 1 administration of study medication and have at least 1 post-baseline disease assessment.|||Percentage of participants|||Number
1443029|NCT00911820|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Patients were followed for up to 2.5 years as of this analysis.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1443030|NCT00911820|Secondary|Overall Response (OR) Rate|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis.|The analysis dataset is comprised of all treated patients.|||proportion of patients||95% Confidence Interval|Number
1443031|NCT00911820|Secondary|Best Response|Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment duration was a median of 5 cycles (up to approximately 1 year) in this study cohort as of this analysis..|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
1443032|NCT00911820|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.|Patients in the study cohort were followed up to approximately 2.5 years as of this analysis.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
1443033|NCT00911820|Primary|7-month Progression-Free Survival|7-month progression-free survival is the probability of patients remaining alive and progression-free at 7-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Relevant for this endpoint was disease status at 7 months of follow-up.|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
1443034|NCT00911807|Secondary|Adverse Experiences, Vital Signs, Physical and Neurological Examinations, Laboratory Tests (Hematology, Clinical Chemistry , Urinalysis, Electrocardiogram [ECG])||Baseline, week 4, 12, 16, 28|||||||
1443035|NCT00911807|Secondary|Combined Responders, i.e. Response in ADAS-COG+ and CIBIC+||week 4, 12, 16, 28|||||||
1443036|NCT00911807|Secondary|Change From Baseline in Total Score for Neuropsychiatric Inventory (NPI)||week 16, 28|||||||
1443037|NCT00911807|Secondary|Change From Baseline for Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)||week 16, 28|||||||
1443038|NCT00911807|Secondary|Clinical Interview-based Impression of Severity (CIBIS+) Score||week 28|||||||
1443039|NCT00911807|Secondary|CIBIC+ Responders||week 4, 12, 16, 28|||||||
1443040|NCT00911807|Secondary|CIBIC+ Score||week 4, 12, 16|||||||
1443041|NCT00911807|Secondary|Change From Baseline for Original ADAS-COG||week 4, 12, 16, 28|||||||
1443042|NCT00911807|Secondary|ADAS-COG+ Responders||week 4, 12, 16, 28|||||||
1443043|NCT00911807|Secondary|Change From Baseline for ADAS-COG+||week 4, 12, 16|||||||
1443044|NCT00911807|Primary|Clinical Interview-based Impression of Change (CIBIC+) Score||week 28|||||||
1443045|NCT00911807|Primary|Change From Baseline in Alzheimer’s Disease Assessment Scale Cognitive Subpart (Extended Version) (ADAS-COG+) at Week 28|The ADAS-cog+ is a validated, widely used, 14 item psychometric instrument for testing cognitive functions with increased sensitivity in detecting changes in milder patients compared to the original ADAS-cog. It has a maximum score of 85 with a higher score indicating impairment and was assessed by a qualified neuropsychologist.|baseline and week 28|Analysis was intention to treat|||points on a scale||Standard Deviation|Mean
1443047|NCT00911768|Secondary|Stimulated Salivary Flow Rates|Stimulated salivary flow rates were compared between 0 and 8 weeks in both groups.|8 weeks|Because secondary outcome of the study was also changes of stimulated salivary flow rates between 0 and 8 weeks, per protocol analysis was applied.|||ml/min||Standard Deviation|Mean
1443048|NCT00911768|Primary|Visual Analogue Scale of Subjective Dry Mouth|Visual Analogue Scale of Subjective Dry Mouth is 10 cm, where 0 cm indicates no dry mouth and 10 cm the severe dry mouth.|8 weeks|Because primay outcome of the study was changes of Visual Analogue Scale of Subjective Dry Mouth between 0, 4 and 8 weeks, per protocol analysis was applied.|||cm||Standard Deviation|Mean
1443049|NCT00911742|Secondary|Tmax|Time to maximum plasma concentration|48 hours||||hours||Full Range|Median
1443050|NCT00911742|Secondary|t1/2|Apparent terminal elimination half-life|48 hours||||hours||Standard Deviation|Mean
1443051|NCT00911742|Primary|Cmax|Maximum plasma concentration|48 hours||||ng/mL||Standard Deviation|Mean
1443052|NCT00911742|Primary|AUC (0-∞)|"The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0–t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R’2 (coefficient of determination). The units are ng.h/mL.~h=hours"|48 hours||||ng.h/mL||Standard Deviation|Mean
1443053|NCT00911742|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measured concentration.~h=hour"|48 hours||||ng.h/mL||Standard Deviation|Mean
1443054|NCT00911625|Secondary|The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter|At the end of the study, the number of participants who experience at least one blood glucose level below 70 milligrams per deciliter (mg/dL) is compared between the two treatment cohorts|6 Days|This analysis comprises all participants who were randomized and completed all study activities|||Participants|||Count of Participants
1443055|NCT00911625|Primary|Average Blood Glucose Over 6 Days|Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts.|6 Days|The analysis population for the primary outcome comprises all participants who were randomized and completed all study activities|||milligrams per deciliter||Standard Deviation|Mean
1443056|NCT00911612|Secondary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|After 12-14 days' treatment||||units on a scale||Standard Error|Mean
1443057|NCT00911612|Secondary|Colonic Transit, Geometric Center at 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days' treatment||||units on a scale||Standard Error|Mean
1443058|NCT00911612|Secondary|Colonic Permeability as Measured by Cumulative Urinary Excretion of Mannitol 8-24 Hours|Colonic permeability is measured through differential excretion of urine saccharides. The subject ingests a methacrylate-coated capsule that contains saccharides (mannitol 1g and lactulose 5 g powder). The capsule provides a means to protect the sugars from absorption, until the sugars are delivered to the colon by means of a standard delayed release capsule. The value reported is the mean for each arm of the total amount of mannitol excreted over the 8-24 hour time period.|after 12-14 days' treatment||||mg||Standard Error|Mean
1443059|NCT00911612|Primary|Ascending Colon Emptying T1/2|The half time for the ascending colon emptying (T1/2) was measured by the scintigraphic method. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule that is swallowed by the subject. Anterior and posterior gamma images are taken hourly. From the hourly scans, a time-activity curve is plotted using linear interpolation between time points when content was measured. The time taken to empty 50% of the isotope from the ascending colon is read from this time-activity curve.|After 12-14 days' treatment||||hours||Standard Error|Mean
1443060|NCT00911612|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit. A GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|After 12-14 days treatment||||units on a scale||Standard Error|Mean
1443061|NCT00911547|Secondary|Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only|"Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, Did you wake up with asthma symptoms? (no, once, more than once, awake “all night”), were assigned numerical values (0, 1, 2, 3, respectively).~The average score for the visit was determined by averaging the daily scores over all days between consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1443079|NCT00911326|Secondary|Lymph Node Detection Rate|The rate of the subjects for whom Lymphoseek identified at least 1 sentinel lymph node. The detection rate point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek||||percentage of participants||95% Confidence Interval|Number
1443192|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 16|Change in the number of migraine days per 30 days at Month 16 relative to the OAT run-in (Month 1). Assessed by participant electronic diary.|Change form Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of Days||95% Confidence Interval|Mean
1443062|NCT00911547|Secondary|Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma|Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Liters/minute||95% Confidence Interval|Least Squares Mean
1443063|NCT00911547|Secondary|Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use|Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1443064|NCT00911547|Primary|Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma|"The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.~The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits."|Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.|||Units on a Scale||95% Confidence Interval|Least Squares Mean
1443065|NCT00911547|Primary|Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma|Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups|Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups|Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values were imputed. Data collected during discontinuation and unscheduled visits were included the analysis. Differences between treatments are evaluated based on LS means|||Percentage of Change||95% Confidence Interval|Least Squares Mean
1443066|NCT00911534|Other Pre-specified|Time to Achieve First 24-Hour Period Without Heartburn|Participants completed a daily symptom diary.|Baseline to Week 4|ITT|||Days||Standard Error|Mean
1443067|NCT00911534|Other Pre-specified|Percentage of Participants With Complete Heartburn Relief|Participants completed a daily symptom diary.|Week 2 and Week 4|ITT (n=number of participants with evaluable data)|||Percentage of Participants|||Number
1443068|NCT00911534|Primary|Mean Percentage of Diary-Recorded Heartburn-Free Days at Week 4|Participants completed a daily symptom diary. A heartburn-free day was defined as participant report of 'No Heartburn' from nighttime and daytime of the diary for the same day.|Week 4|Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug (n=number of participants with evaluable data)|||Percentage of Days||Standard Deviation|Mean
1443069|NCT00911534|Secondary|Change From Baseline in Average Daily Severity Score of Gastroesophageal Reflux Disease (GERD)-Related Symptoms at Week 4|Participants collected GERD-associated symptoms of daytime heartburn, nighttime heartburn and regurgitation in daily symptom diary. Daytime episodes were defined as those that occurred after arising in the morning until retiring in the evening, and nighttime episodes were defined as those that occurred during the night while sleeping or trying to sleep. The severity score was calculated was based on a 5-point Likert scale ranging from 0 (no symptom) to 4 (very severe symptom); higher scores indicated greater disease activity.|Baseline and Week 4|ITT|||Scores on a Scale||Standard Deviation|Mean
1443070|NCT00911495|Secondary|Volume of the Peripheral Compartment||48 hours||||mL/kg||Standard Deviation|Mean
1443071|NCT00911495|Secondary|Intercompartmental Clearance||48 hours||||mL/h/kg||Standard Deviation|Mean
1443072|NCT00911495|Secondary|Volume of the Central Compartment||48 hours||||mL/kg||Standard Deviation|Mean
1443073|NCT00911495|Other Pre-specified|Blood Flow and Biomarkers of Adhesion|As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity.|48 hours|||||||
1443074|NCT00911495|Secondary|Total Plasma Clearance||48 hours|All subjects were analyzed for pharmacokinetics; one subject of the 15 enrolled was lost to follow-up.|||mL/h/kg||Standard Deviation|Mean
1443075|NCT00911495|Primary|Safety as Measured by the Number of Participants With Adverse Events||28 days|All enrolled subjects were analyzed for safety.|||participants|||Number
1443076|NCT00911443|Primary|Overall Tumor Response|Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response|1 year||||participants|||Number
1443077|NCT00911443|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from the randomization to progression or death|2 years||||months||95% Confidence Interval|Median
1443078|NCT00911443|Secondary|Overall Survival|The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored.|2 years||||months||95% Confidence Interval|Median
1443238|NCT00910247|Secondary|Percentage of Subjects That Are Seizure-free During Study|Percentage of subjects that are seizure-free during study|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentage of participants|||Number
1443080|NCT00911326|Secondary|Overall Accuracy|The overall accuracy is calculated as a percentage from the ratio of (true positives + true negatives) / (true positives + false negatives + true negatives). The overall accuracy point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.|Surgery after injection of Lymphoseek||||percentage of participants||95% Confidence Interval|Number
1443081|NCT00911326|Secondary|Negative Predictive Value (NPV)|The NPV is calculated as a percentage from the ratio of true negatives to the sum of true negatives plus false negatives. The NPV point estimate was the observed rate and was made on a per-patient basis relative to patients predicted to be pathology-negative.|Surgery after injection of Lymphoseek||||% of participants predicted negative||95% Confidence Interval|Number
1443082|NCT00911326|Primary|False Negative Rate (FNR)|The FNR is calculated as a percentage from the ratio of false negatives to the sum of true positives plus false negatives. The FNR point estimate was the observed rate and was made on a per-patient basis relative to patients with pathology-positive nodes.|Surgery after injection of Lymphoseek||||% of pathology-positive participants||95% Confidence Interval|Number
1443083|NCT00911300|Secondary|Number of Participants Who Were Re-hospitalized|Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
1443084|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm|Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
1443085|NCT00911300|Secondary|Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE|Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF.|At second TEE (at Day 28+/-4)|mITT Population. Only clot-positive participants at the time of the first TEE were analyzed.|||participants|||Number
1443086|NCT00911300|Secondary|Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm|CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed.|Day 1 until Day 3|mITT Population. Only participants with data for primary successful electric cardioversion at the indicated timepoint were analyzed.|||participants|||Number
1443087|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
1443088|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event|Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
1443089|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause|The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
1443090|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism|Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
1443091|NCT00911300|Secondary|Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)|mITT Population|||participants|||Number
1443092|NCT00911300|Primary|Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days|Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.|Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants|Modified Intent-to-Treat (mITT) Population: all randomized participants receiving at least one dose of study medication and for whom any post-baseline value was available|||participants|||Number
1443093|NCT00911274|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
1443094|NCT00911274|Primary|AUC0-inf - Area Under Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
1443095|NCT00911274|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
1443096|NCT00911170|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an adverse event that - is fatal; - is life threatening (places the participant at immediate risk of death); - requires inpatient hospitalization or prolongation of existing hospitalization; - results in persistent or significant disability/incapacity; - is a congenital anomaly/birth defect; - other significant medical hazard. AEs were assessed for severity according to National Cancer Institute, Common Terminology Criteria for Adverse Events, Version 3.0, based on this general guideline: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.|Approximately 8 weeks (4 treatment cycles)|Safety analysis set, defined as all participants in the Primary Analysis Set who received at least one dose of investigational product (IP; placebo or pegfilgrastim). One participant was randomized to the placebo arm but actually received pegfilgrastim and is included in the pegfilgrastim arm for the safety analyses.|||participants|||Number
1443097|NCT00911170|Secondary|Percentage of Participants With Grade 4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <0.5 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1443098|NCT00911170|Secondary|Percentage of Participants With Grade 3/4 Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 severe neutropenia is defined as neutropenia with absolute neutrophil count (ANC) <1.0 x 10^9/L.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1443099|NCT00911170|Secondary|Percentage of Participants With Grade 4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|"Grade 4 febrile neutropenia (FN) is defined as:~A temperature ≥ 38.0ºC (≥ 100.4ºF) and absolute neutrophil count (ANC) < 0.5 × 10^9/L, where ANC is measured the same day or within +/- 1 calendar day of a temperature ≥ 38.0ºC (≥ 100.4ºF), or~An ANC <0.5 × 10^9/L in combination with:~Documented sepsis or infection, OR~Neutropenia-related hospitalization where ANC is measured the same day or within +/- 1 calendar day."|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
1443100|NCT00911170|Secondary|Percentage of Participants With an Objective Response|The percentage of participants with a complete response (CR) or partial response (PR) defined by the RECIST v1.1 criteria at any time during the study. Response was be determined by the investigator’s assessment of radiographic scans. CR: Disappearance of all non-nodal target lesions and the disappearance of all non-nodal non-target lesions, and no new lesions. All nodal lesions must have reduction of short axis to < 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters and no new lesions and/or unequivocal progression of existing non-target lesions, or, the disappearance of all non-nodal target lesions with persistence of one or more non-target lesion(s).|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set participants with measurable disease at Baseline.|||percentage of participants||95% Confidence Interval|Number
1443111|NCT00911144|Secondary|Concentration of Antibodies Against Protein D (PD)|Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||ELISA units per milliliter||95% Confidence Interval|Geometric Mean
1455736|NCT00810069|Secondary|Number of Participants With Adverse Events (AEs)|The list of AEs is located in the Reported Adverse Event module.|Baseline through Week 16|Full Analysis Population|||participants|||Number
1443101|NCT00911170|Secondary|Time to Progression|Time from randomization to date of radiological disease progression calculated using the Kaplan-Meier method. Participants without progression were censored on the date of their last radiographic tumor assessment. Disease progression based on the investigator’s assessment of scans using the RECIST v1.1. Clinical progression without radiological assessment was not considered a disease progression. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set|||months||95% Confidence Interval|Median
1443102|NCT00911170|Secondary|Progression Free Survival|Time from randomization to date of radiological disease progression or death from any cause, whichever event occurs first, calculated using the Kaplan-Meier method. Participants without either event by the analysis data cutoff date were censored on the date of their last evaluable disease assessment. Disease progression based on the investigator’s assessment of radiographic scans using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Clinical progression without radiological assessment was not be considered a disease progression in this analysis. Progression defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set|||months||95% Confidence Interval|Median
1443103|NCT00911170|Secondary|Overall Survival|Median time from randomization to date of death caclulated using the Kaplan-Meier method. Participants were censored on the date of last contact (i.e., the date the participant was last known to be alive) if they were not known to have died.|From randomization to the data cut-off date of 8 June 2012. Median time on study was 11.6 months and the maximum was 27.6 months.|Primary analysis set|||months||95% Confidence Interval|Median
1443104|NCT00911170|Primary|Percentage of Participants With Grade 3/4 Febrile Neutropenia Across the First 4 Cycles of Chemotherapy|Grade 3/4 febrile neutropenia (FN) is defined as: • A temperature ≥ 38.0°C (≥ 100.4°F) and absolute neutrophil count (ANC) < 1.0 × 10^9/L, where ANC was measured the same day or within ± 1 calendar day of a temperature ≥ 38.0°C (≥ 100.4°F), or • An ANC < 1.0 × 10^9/L in combination with: – documented sepsis or infection, OR – neutropenia-related hospitalization where ANC was measured the same day or within ± 1 calendar day. Participants monitored their oral temperatures and maintained diaries to record their temperature twice per day: once in the morning and once in the evening, as well as whenever they suspect they had fever throughout the first 4 cycles of chemotherapy treatment.|Approximately 2 months duration (Daily for 4 cycles of treatment; 2 weeks per cycle)|The primary analysis set which included all participants with a signed informed consent, and who were randomized and received at least 1 dose of protocol-specified study treatment (chemotherapy, bevacizumab, or investigational product).|||percentage of participants||95% Confidence Interval|Number
1443105|NCT00911157|Secondary|Percentage of Participants With a Bleeding Event|Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS).|Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).|Safety Population: all participants who received at least one dose of medication (FPX or UFH).|||percentage of participants|||Number
1443106|NCT00911157|Secondary|Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10|Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe).|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS|||points on a scale||Standard Deviation|Mean
1443107|NCT00911157|Secondary|Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline|"Classifications of Improved, No change, or Worse were adjudicated blindly by the CIACE."|Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)|FAS|||percentage of participants|||Number
1443108|NCT00911157|Secondary|Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE.|From Day 1 to Day 90 (±7 days)|FAS|||percentage of participants|||Number
1443109|NCT00911157|Primary|Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)|VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE).|From Day 1 to Day 90 (±7 days)|Full Analysis Set (FAS): all participants receiving at least one dose of medication (FPX or UFH) who had efficacy data and had a confirmed diagnosis of acute symptomatic deep vein thrombosis (DVT)|||percentage of participants|||Number
1443110|NCT00911144|Secondary|Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)|Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||microgram per milliliter||95% Confidence Interval|Geometric Mean
1443174|NCT00910845|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||milliliters||Standard Deviation|Mean
1443112|NCT00911144|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||titer||95% Confidence Interval|Geometric Mean
1443113|NCT00911144|Secondary|Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A|Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||microgram per milliliter||95% Confidence Interval|Geometric Mean
1443114|NCT00911144|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.~Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||titer||95% Confidence Interval|Geometric Mean
1443115|NCT00911144|Secondary|Concentration of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter.~Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after booster vaccination (Month 1)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data were available for antibodies against at least one study vaccine antigen after booster vaccination.|||microgram per milliliter||95% Confidence Interval|Geometric Mean
1443116|NCT00911144|Secondary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|After booster vaccination up to study end (Month 0 to Month 1)||||subjects|||Number
1443117|NCT00911144|Secondary|Number of Subjects Reporting Unsolicited Adverse Events|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|Within 31 days (Days 0 to 30) after booster vaccination||||subjects|||Number
1443118|NCT00911144|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.|Within 4 days (Days 0 to 3) after booster vaccination|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||subjects|||Number
1443119|NCT00911144|Primary|Number of Subjects Reporting Grade 3 Adverse Events|Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.|Within 31 days (Day 0 - Day 30) after booster vaccination.|Analysis was performed on the Total vaccinated cohort on the subjects with available data.|||subjects|||Number
1443120|NCT00910988|Primary|Adipose Tissue Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as free fatty acid release (glycerol rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||% change from basal to insulin phase||Standard Deviation|Mean
1443121|NCT00910988|Primary|Peripheral Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as primarily muscle glucose utilization (glucose rate of disappearance [Rd]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||% change from basal to insulin phase||Standard Deviation|Mean
1443122|NCT00910988|Primary|Hepatic Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as hepatic glucose production (glucose rate of appearance [Ra]).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||% change from basal to insulin phase||Standard Deviation|Mean
1443123|NCT00910988|Primary|Whole Body Insulin Sensitivity|To evaluate, using a within-subject placebo-controlled comparison, the acute effects of olanzapine or ziprasidone administration on insulin sensitivity in antipsychotic-naïve healthy young men, measured as whole-body dextrose infusion rates (mg/kg/min).|approximately 3 hours|The analysis was per protocol and involved subjects who completed both a clamp that involved an injection of either olanzapine or ziprasidone, and a clamp that involved a placebo injection. Nine subjects did not complete a second clamp as they were lost to follow-up. This resulted in the analysis of 37 participants.|||mg/kg/min||Standard Deviation|Mean
1443124|NCT00910962|Secondary|Mean Hyperenhancement Score Index at Week 12|The myocardium was divided into 17 segments. A score ranging from 0 to 4 was visually attributed to each of the 17 segments according to the transmural extent of the hyperenhancement: score 0=0%, 1=>0-25%, 2=>25-50%, 3=>50-75% and 4=>75-100%. All these 17 scores were summed. The resulting summed score ranged in theory from 0 to 68 and was thereafter expressed as a percentage of the maximum possible score of 68, with higher percentages indicating hyper-enhancement in a greater percentage of the tissue in a greater number of segments. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. Statistical analysis was performed on LS mean value using repeated measures ANCOVA.|At week 12|MRI ITT Population. Only those participants with data available at week 12 were analyzed.|||Scores on a scale||Standard Deviation|Mean
1443125|NCT00910962|Secondary|Mean Regional Wall Motion Score Index at Week 12|Wall motion score index is a semi-quantitative analysis of regional systolic function. Each segment is analyzed individually and scored on the basis of its motion and systolic thickening. This score is a 5-level score defines as: 1=normokinesis or hyperkinesis, 2=hypokinesi, 3=akinesis, 4=dyskinesis, 5=aneurysm. Wall motion score index is derived as a sum of all scores divided by the number of segments visualized. Larger score index indicates higher degree of abnormalities. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
1443126|NCT00910962|Secondary|Mean Left Ventricular Mass at Week 12|Statistical analyses of the treatment differences was performed to compare the left ventricular mass (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo.Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||grams (gm)||Standard Deviation|Mean
1443127|NCT00910962|Secondary|Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12|Statistical analyses of the treatment differences was performed to compare the LVEDV and LVESV (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||mL||Standard Deviation|Mean
1443128|NCT00910962|Secondary|Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12|Statistical analyses of the treatment differences was performed to compare the LVEF (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|At Week 12|MRI ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percent||Standard Deviation|Mean
1443129|NCT00910962|Secondary|Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12|Statistical analyses was performed to compare the infarct size (via MRI) at Week 12 via repeated measures ANOVA between study drug and placebo using Bayesian methods for inference. Myocardial infarct size was measured by delayed enhancement magnetic resonance imaging (MRI) as: Infarct size (% of left ventricular myocardium [% of LV]) for infarct 1. The infarct region 1 was the infarct region which the MRI interpretation process identified as the primary infarct region of the index hospitalization. Participants were included in the analyses, provided they have data for derivation of the measures of interest (MR infarct size). A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.|Prior to discharge (visit 1) and at Week 12|MRI ITT Population was subset of participants in the ITT Population who had at least one MRI scan. Only those participants available at the specified time points were analyzed.|||Percent of left ventricle||Standard Deviation|Mean
1443130|NCT00910962|Secondary|Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12|Statistical analyses was performed to compare BNP levels between study drug and placebo. Log transformed ratio to Baseline BNP was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline BNP as a covariate, and accounting for other covariates as appropriate to the study design.|At discharge and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1443131|NCT00910962|Secondary|Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|Statistical analyses was performed to compare cTnI levels between study drug and placebo. Log transformed ratio to Baseline cTnI was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline cTnI as a covariate, and accounting for other covariates as appropriate to the study design.|Up to 72 hours|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443175|NCT00910845|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||micturition episodes||Standard Deviation|Mean
1443132|NCT00910962|Secondary|Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|Statistical analyses was performed to compare CK-MB levels between study drug and placebo. Log transformed ratio to Baseline CK-MB was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline CK-MB as a covariate, and accounting for other covariates as appropriate to the study design.|At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72|ITT Population. Only those participants available at the specified time points were analyzed.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1443133|NCT00910962|Secondary|Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12|Statistical analyses was performed to compare IL-6 levels between study drug and placebo. Log transformed ratio to Baseline IL-6 was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline IL-6 as a covariate, and accounting for other covariates as appropriate to the study design.|24 hours post-randomization and at Weeks 2 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1443134|NCT00910962|Secondary|Mean hsCRP Over Hospitalization Period and Through Week 14|Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. The sample had a collection window of +/- 8 hours. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using ANCOVA including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.|Up to Week 14|ITT Population. Only those participants available at the specified time points were analyzed.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1443135|NCT00910962|Primary|Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)|cTnI AUC was the average concentration of cTnI during hospital stay. Statistical analyses was performed to compare cTnI levels between study drug and placebo, via ANCOVA.|At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours|ITT Population. Only those participants available at 72 hours were analyzed.|||nonograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1443136|NCT00910962|Primary|Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12|Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using repeated measures analysis of covariance (ANCOVA) including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.|At Week 12|Intent-to-treat (ITT) Population comprised all randomized participants who received at least one dose of study medication and at least one on treatment assessment. Only those participants with data available at Week 12 were analyzed.|||mg per liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1443137|NCT00910962|Primary|Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline|Vital signs (PCI range): Systolic blood pressure (SBP) (<75 and >200 millimeter of mercury [mmHg]), Diastolic blood pressure (DBP) (<40 and >120 mmHg) and Heart rate (<30 and >200 beats per minute [bpm]) were analyzed and were presented at any visit post-Baseline. Participants with both Normal and Low values were counted once under their worst case (Low). Participants with both Normal and High values were counted once under their worst case (High). Participants with both High and Low values were counted under both categories. All heart rate values were within normal range, hence not presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
1443138|NCT00910962|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline|A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. ECG findings were presented as Normal, Abnormal - Not clinically significant and Abnormal – Clinically significant at any time post-Baseline.|Up to Week 14|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1443139|NCT00910962|Primary|Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline|Liver function test parameters: Alanine aminotransferase (ALT), Total Bilirubin (T. Bilirubin), Aspartate aminotransferase (AST), Alkaline Phosphatase, Gamma glutamyl transferase (GGT) and Creatine Kinase were analyzed and presented as elevated test values at any time post-Baseline. The elevations were presented as >=2xULN, >=3xULN, >=5xULN, >=10xULN, and >=20xULN. n= number of participants with at least one non-missing result of the particular lab test post-Baseline.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
1443140|NCT00910962|Primary|Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline|Clinical chemistry parameters (PCI range): Alanine Amino Transferase (ALT) (>=3x upper limit normal [ULN] units per liter [U/L]), Albumin (<25.6 or >60 g/L), Alkaline Phosphatase (>=2x ULN U/L), Aspartate Amino Transferase (AST) (>=3x ULN U/L), Calcium (<2.0776 or >2.6112 millimoles per liter [mmol/L]), Carbon dioxide content/Bicarbonate (CO2/HCO3) (<19.6 or >32.64 mmol/L), Chloride (<93.1 or >110.16 mmol/L), Creatinine (<39.6 or >136.4 micromole per liter [µmol/L]) , Glucose (<3.51 or >6.05 mmol/L), Potassium (<3.43 or >5.406 mmol/L), Sodium (<132.3 or >148.92 mmol/L), Total Bilirubin (T. bilirubin) (>=1.5xULN µmol/L) , Total Protein (<50 or >95 g/L), Urea/Blood urea nitrogen (BUN) (<2.25 or >11.55 mmol/L) and Uric acid (<135 or >495 µmol/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
1443151|NCT00910910|Secondary|Euro Quality of Life Five Dimension (EQ-5D) Questionnaire|The standardized extended version of EQ-5D was designed for the collection of health state values using a visual analogue scale (VAS) rating scale - a vertical 20 cm visual analogue scale with the end points labeled best imaginable health state at the top and worst imaginable health state at the bottom having numeric values of 100 and 0 respectively. The participant is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.|Day 1 and once every 8 weeks|No data were collected for the EQ-5D QOL assessment.EQ-5D analysis was not conducted due to the discontinuation of the Lenalidomide arm||||||
1443141|NCT00910962|Primary|Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline|Hematology parameters (PCI range): Eosinophils (<0.045 or >0.605 Giga cells per liter [GI/L]), Hematocrit (<0.297 or >0.506 ratio), Hemoglobin (<85 or >200 grams per liter [g/L]), Lymphocytes (<0.765 or >4.51GI/L), Mean Corpuscle Hemoglobin (MCH) (<24.3 or >38.5 picograms [PG]), Mean Corpuscle Hemoglobin Concentration (MCHC) (<256 or >432 g/L), Mean Corpuscle Volume (MCV) (<70 or >115 femtoliter [FL]), Monocytes (<0.18 or >1.21 GI/L), Platelet count (<104 or >480 GI/L), Red Cell Distribution Width (RDW) (<7.2 or >18%), Red Blood Cell (RBC) count (<2.88 or >6.12 trillion per liter [TI/L] for females and <3.52 or >6.96 TI/L for males) , Reticulocytes (<22.5 or >93.5 10^9/L), Total Absolute Neutrophil Count (ANC) (<1.62 or >8.8 GI/L), White Blood Cell (WBC) count (<3.04 or >12 GI/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.|Up to Week 14|Safety Population. Number of participants with analyzable samples at the time of analysis were included.|||Participants|||Count of Participants
1443142|NCT00910962|Primary|Number of Participants With Any Pure MACE|Pure MACE was defined as all-cause death, adjudicated myocardial infarction or stroke/transient ischemic attack.|Up to Week 14|Safety Population.|||Participants|||Count of Participants
1443143|NCT00910962|Primary|Number of Participants With Any Major Adverse Cardiovascular Events (MACE)|MACE was defined as all-cause death, adjudicated myocardial infarction, stroke/transient ischemic attack, heart failure or recurrent ischemia requiring urgent revascularization.|Up to Week 14|Safety Population|||Participants|||Count of Participants
1443144|NCT00910962|Primary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to Week 14|Safety Population consisted of all participants randomized to treatment, who had taken at least one dose of study medication.|||Participants|||Count of Participants
1443145|NCT00910910|Secondary|Number of Participants With Subsequent Anti-cancer Therapies Received Post Treatment|Subsequent anti-cancer therapies administered to participants following the discontinuation of study drug (either Lenalidomide or Chlorambucil)|Up to data cut-off of 31 March 2014; up to approximately 53 months|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).|||participants|||Number
1443146|NCT00910910|Secondary|Time to Response|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|Intent to treat participants with an objective response as of 18 February 2013|||weeks||Full Range|Median
1443147|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 18 Feb 2013; up to approximately 39 months|Intent to Treat population with an objective response as of 18 February 2013|||weeks||95% Confidence Interval|Median
1443148|NCT00910910|Secondary|Percentage of Participants With Overall Response Based on IWCLL Guidelines With a Later Cut-off of 31 March 2014|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:~Complete Remission (CR):~No lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~No circulating clonal B-lymphocytes~Platelets > 100,000/ul~Hemoglobin > 11.0 g/dl~Normocellular <30% lymphocytes, no B-lymphoid nodules;~Incomplete Clinical Response (CRi):~• CR without bone marrow biopsy confirmation.~Nodular Partial Response:~• CR with the presence of residual clonal nodules.~Partial Response requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul"|Up to data cut-off of 31 March 2014; approximately 53 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not|||percentage of participants with response|||Number
1443149|NCT00910910|Secondary|Percentage of Participants With the Best Overall Response Based on the International Workshop on Chronic Lymphocytic Leukemia Guidelines (IWCLL) Guidelines|"A best overall response rate is a CR, CRi, nPR or PR and is defined as:~Complete Remission (CR):~No lymphadenopathy~No hepatomegaly or splenomegaly~Absence of constitutional symptoms~Polymorphonuclear leukocytes ≥ 1500/ul~No circulating clonal B-lymphocytes~Platelets > 100,000/ul~Hemoglobin > 11.0 g/dl~Normocellular <30% lymphocytes, no B-lymphoid nodules;~Incomplete Clinical Response (CRi):~• CR without bone marrow biopsy confirmation.~Nodular Partial Response (nPR):~• CR with the presence of residual clonal nodules.~Partial Response (PR) requires:~≥ 50% decrease in peripheral blood lymphocyte count~≥ 50% reduction in lymphadenopathy~≥ 50% reduction in size of liver and/or spleen~1 or more of the following:~Polymorphonuclear leukocytes ≥ 1500/ul~Platelets >100,000/ul"|Up to data cut-off of 18 Feb 2013; approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||percentage of participants|||Number
1443150|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator’s assessment or death due to any cause on study, whichever occurred first. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression|Data cut-off of 18 Feb 2013; up to approximately 39 months|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
1443152|NCT00910910|Secondary|Functional Assessment of Cancer Therapy-General to Create the FACT-Leukemia (FACT-Leu) Quality of Life Instrument|The FACT-Leu scale is a valid, reliable, and efficient measure of leukemia-specific health-related quality of life for acute and chronic disease. The FACT-Leu is described as including 27 items that assess 17 physical symptoms (fevers, bleeding, general pain, stomach pain, chills, night sweats, bruising, lymph node swelling, weakness, tiredness, weight loss, appetite, shortness of breath, functional ability, diarrhea, concentration, and mouth sores) and 10 emotional/social concerns (frustration with activity limitation, discouraged by illness, future planning, uncertainty, worry about illness, emotional lability, isolation, infertility concern, family worry, and worry about infections).|Day 1 and once every 8 weeks|No data were collected for the FACT-Leu QOL assessment. Analysis not conducted due to the discontinuation of the Lenalidomide arm||||||
1443153|NCT00910910|Secondary|Kaplan Meier Estimate of Overall Survival for a Later Cut-off of 31 March 2014|Overall Survival is defined as the time between randomization and death from any cause.|Up to data cut off of 31 March 2014; up to approximately 53 months; median follow-up was 18.8 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||Months||95% Confidence Interval|Median
1443154|NCT00910910|Secondary|Kaplan Meier Estimate for Overall Survival|Overall Survival is defined as the time between randomization and death from any cause..|Up to data cut off of 18 Feb 2013; up to approximately 39 months;|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not as of 18 February 2013.|||Months||95% Confidence Interval|Median
1443155|NCT00910910|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS) With a Later Cut-off of 31 March 2014|Progression-free survival was defined as the time from randomization to the first documented progression confirmed per investigator’s assessment or death due to any cause on study, whichever occurred first. Progressive disease included lymphadenopathy, an appearance of any new lesion such as enlarged lymph nodes (> 1.5 cm), splenomegaly, hepatomegaly or other organ infiltrates, an increase by 50% or more in greatest determined diameter of any previous site or an increase by 50% or more in the sum of the product of diameters of multiple nodes. The progression date was assigned to the earliest time when any progression was observed without prior missing assessments. If withdrawal of consent or lost to follow-up occurred before documented progression or death, then these observations were censored at the date when the last complete tumor assessments determined a lack of progression.|Data cut-off of 31 March 2014; up to approximately 53 months|The Intent-to-Treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not.|||months||95% Confidence Interval|Median
1443156|NCT00910910|Secondary|Time to Response for a Later Cut-off of 31 March 2014|Time to response was calculated as the time from randomization to the first nPR, PR, CRi or CR based on IWCLL guidelines|Up to data cut-off of 31 March 2014; up to approximately 53 months|Intent to Treat participants with an objective response|||weeks||Full Range|Median
1443157|NCT00910910|Secondary|Kaplan-Meier Estimate for Duration of Response With a Later Cut-off of 31 March 2014|Duration of response was defined as the time from first nPR, PR, CRi, or CR to PD. Duration of response was censored at the last date that the patient was known to be progression-free for: 1) patients who had not progressed at the time of analysis; 2) patients who had withdrawn consent or were lost to follow-up prior to documentation of progression|Up to data cut-off of 31 March 2014; up to approximately 53 months|Intent to Treat participants with an objective response|||weeks||95% Confidence Interval|Median
1443158|NCT00910910|Secondary|Number of Participants With Adverse Events (AEs) With a Later Cut-off of 31 March 2014|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization to the data cut-off of 31 March 2014; Up to 53 months; maximum duration of exposure for Lenalidomide was 1140 days and 406 days for Chlorambucil|The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil).|||participants|||Number
1443159|NCT00910910|Secondary|Number of Participants With Adverse Events (AEs)|AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From randomization up to data cut-off of 18 Feb 2013; Up to approximately 39 months; maximum duration of exposure for Lenalidomide was 1086 days and 406 days for Chlorambucil|This is a smaller population used in this analysis (earlier cut-off date) prior to the last participant enrolled in the study. The safety population was defined as all randomized participants who received at least 1 dose of the study treatment (either lenalidomide or chlorambucil) as of the data cut off date of 18 Feb 2013|||participants|||Number
1443173|NCT00910858|Primary|PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose for lenalidomide after a single dose, calculated using the log-linear trapezoidal method.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours post-dose.|All Pharmacokinetic Phase participants.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443160|NCT00910871|Secondary|The Percentage of Participants With Sputum Culture Conversion|The table below shows the percentage of participants who were responders to treatment. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued or died during the trial were considered non-responders.|Week 120|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.|||Percentage of Participants|||Number
1443161|NCT00910871|Primary|The Median Time to Sputum Culture Conversion|The table below shows the median time in days to culture conversion for the modified intent-to-treat (mITT) population up to Week 24. Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multi-drug resistant tuberculosis (MDR-TB) taken at least 25 days apart. Participants who discontinued during the 24-week period were considered non-responders (based on Mycobacteria Growth Indicator Tube [MGIT]).|Up to Week 24|The modified intent-to-treat (mITT) population used for all efficacy analyses included all randomized participants who received at least 1 dose of TMC207 excluding participants with drug-susceptible tuberculosis (DS-TB) or participants that were not evaluable for efficacy.|||Days||95% Confidence Interval|Median
1443162|NCT00910858|Secondary|Marrow-infiltrating Lymphocyte (MIL) Number and Cytolytic Activity|Due to the low number of bone marrow samples collected this analysis was not performed.|Pre-Study and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses||||||
1443163|NCT00910858|Primary|Monotherapy Phase: Area-under-the Concentration-time Curve (AUC0-5) for Lenalidomide|Area under the plasma concentration-time curve from Time 0 to 5 hours postdose for lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days, calculated using the log-linear trapezoidal method.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443164|NCT00910858|Secondary|Change From Baseline in Bone Marrow Cellularity and Correlation With Grade 4 Myelosuppression|Bone marrow cellularity is the volume ratio of hematopoietic stem cells and adipocytes (fat cells). Due to the small number of bone marrow samples, this analysis was not performed.|Baseline and Week 16|Unable to obtain sufficient bone marrow samples to perform analyses.||||||
1443165|NCT00910858|Secondary|Percentage of Participants Overall With Erythroid Response by Baseline Erythropoietin Level|To evaluate the predictive value of pretreatment serum erythropoietin (EPO) concentration for erythroid response to lenalidomide, the percentage of erythroid responders versus non-responders were stratified by Baseline EPO levels (≤ 500 mIU/mL versus > 500 mIU/mL). Response includes participants with either a major or minor response.|Assessed every 28 days until study discontinuation (up to 1218 days)|Safety population.|||percentage of participants|||Number
1443166|NCT00910858|Secondary|Percentage of Participants With a Erythroid Response Across All Phases|Erythroid response was categorized as either a major response or a minor response. A major response was defined as red blood cell (RBC) transfusion independence during any consecutive 56-day period and an increase in hemoglobin of at least 1.5 g/dL. A minor response was defined as a ≥ 50% or ≥ 4 unit decrease in RBC transfusions from pretreatment requirements (the number of RBC transfusions required over an 8-week period before the start of study drug treatment).|Assessed every 28 days until study discontinuation (up to 1218 days).|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.|||percentage of participants|||Number
1443167|NCT00910858|Secondary|Time to Grade 4 Neutropenia or Thrombocytopenia|Time to the first event of grade 4 neutropenia or thrombocytopenia, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0, was calculated as date of first event - date of first dose + 1.|From the date of first dose until 30 days after the last dose (up to 1218 days)|Safety population, which comprised all enrolled patients who took at least 1 dose of study drug during the Monotherapy Phase or the Combined Treatment Phase.|||days||Full Range|Median
1443168|NCT00910858|Secondary|Monotherapy Phase: Percent of Lenalidomide Excreted Over 5 Hours Post Day 14 Dose|"Percent of the administered lenalidomide dose excreted unchanged in urine over 5 hours postdose after multiple dosing for 14 days, calculated as:~(amount excreted unchanged in urine over the first 5 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day 14, at predose and over the interval of 0-5 hours postdose.|Monotherapy Phase Pharmacokinetic Population.|||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
1443169|NCT00910858|Secondary|PK Phase: Percent of Administered Lenalidomide Excreted Over 24 Hours After a Single, Oral Dose|"Percent of the administered dose of lenalidomide excreted unchanged in urine over 24 hours postdose after a single dose on Day -7, calculated as:~(amount excreted unchanged in urine over 24 hours postdose / Dose) * 100.~The dose was 10 mg for total lenalidomide and 5 mg for the enantiomers."|On Day -7 at predose and over the intervals of 0-5, 5-8, 8-12, and 12-24 hours postdose.|PK Phase participants for whom data was available.|||percent of administered dose||Geometric Coefficient of Variation|Geometric Mean
1443170|NCT00910858|Secondary|PK Phase: Terminal Half-life (t1/2)|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|Pharmacokinetic Phase participants.|||hours||Geometric Coefficient of Variation|Geometric Mean
1443171|NCT00910858|Secondary|Monotherapy Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The Maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after multiple dosing for 14 days.|On Day 14 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, and 5 hours postdose.|Monotherapy Phase pharmacokinetic population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443172|NCT00910858|Secondary|PK Phase: Maximum Plasma Concentration of Lenalidomide (Cmax)|The maximum observed plasma concentration (Cmax) of lenalidomide (its R- and S- enantiomers and the enantiomers combined) after a single dose on day -7.|On Day -7 blood samples were taken at predose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose.|All Pharmacokinetic Phase participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443176|NCT00910845|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||Incontinence episodes||Standard Deviation|Mean
1443177|NCT00910728|Primary|Inhibition of PSTAT3 (Count)|PSTAT3 inhinition|2hrs and 4 hrs post dose||||# patients with 50% reduction in PSTAT3|||Number
1443178|NCT00910728|Primary|Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss|Multiple dose Tmax,ss (h)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10||||h||Full Range|Median
1443179|NCT00910728|Primary|Pharamcokinetic Parameters Following Single Dosing: Tmax|Single dose Tmax (h)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)||||h||Full Range|Median
1443180|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: CLss/F|Multiple dose CLss/F (L/h)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||L/h||Standard Deviation|Geometric Mean
1443181|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: CL/F|Single dose CL/F (L/h)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||L/h||Standard Deviation|Geometric Mean
1443182|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: Vz/F|Single dose Vz/F (L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).~Due to the nature of the dosing schedule this PK parameter was not reported for the BID (twice daily dosing) groups."|||L||Standard Deviation|Geometric Mean
1443183|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: Cmax|Single dose Cmax (ug/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug/L||Standard Deviation|Geometric Mean
1443184|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss|Multiple dose Cmin,ss (ug/L)|On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10.|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug/L||Standard Deviation|Geometric Mean
1443185|NCT00910728|Primary|Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss|Multiple dose Cmax,ss (ug/L)|On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug/L||Standard Deviation|Geometric Mean
1443186|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing:AUC0-inf|Single dose AUC(0 to infinity) (ug*h/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).~From the BID (twice a day dosing schedules) we can not derive the PK parameter AUC0_inf following single dosing. With that these do not contribute."|||ug*h/L||Standard Deviation|Geometric Mean
1443187|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: AUC0-24|Single dose AUC0-24 (ug*h/L)|0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).~From the BID schedule we can not derive the single dosing AUC0_24 and hence this is not presented/calculated."|||ug*h/L||Standard Deviation|Geometric Mean
1443188|NCT00910728|Primary|Pharmacokinetic Parameters Following Single Dosing: AUC0-12|Single dose AUC0-12 (ug*h/L)|0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)|"Pharmacokinetic.~Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available)."|||ug*h/L||Standard Deviation|Geometric Mean
1443189|NCT00910715|Secondary|Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.|"6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week.~For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe)."|6 months after treatment|number of participants with nonspecific symptoms|||number of participants|||Number
1443190|NCT00910715|Primary|Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.|At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.|1 year follow-up|Number of participants with complete response to treatment.|||number of participants|||Number
1443191|NCT00910689|Secondary|Change in Quality of Life at Month 16|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores relative to OAT run-in. The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Scores on a scale||95% Confidence Interval|Mean
1443193|NCT00910689|Secondary|Change in Number of Migraine Episodes Per 30 Days at Month 16.|Change in number of migraine episodes (with 24 hours pain free period required between episodes) per 30 days from OAT run-in (Month 1) to Month 16. Assessed by participant daily electronic diary.|Change from Month 1 to Month 16|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of Migraine Episodes||95% Confidence Interval|Mean
1443194|NCT00910689|Secondary|Change in Quality of Life at Month 10|Change in Migraine Specific Quality of Life Questionnaire (MSQL; Martin, et al., 2000: v 2.1) scores at Month 10 relative to OAT run-in (Month 1). The MSQL is a 14-item self-report measure that assesses the impact of migraine. The total score ranges from 14 to 84 with higher scores reflecting greater impairment.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Scores on a scale||95% Confidence Interval|Mean
1443195|NCT00910689|Secondary|Change in the Number of Migraine Days Per 30 Days at Month 10|Change in the number of days with migraine per 30 days at Month 10 relative to the OAT Run-in (Month 1). Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of days||95% Confidence Interval|Mean
1443196|NCT00910689|Primary|Change in Number of Migraine Episodes Per 30 Days at Month 10.|Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary.|Change from Month 1 to Month 10|Efficacy analyses were intent-to-treat analyses that included all randomized (N = 232) participants.|||Number of Migraine episodes||95% Confidence Interval|Mean
1443197|NCT00910663|Primary|AUC0-t|Bioequivalence based on AUC0-t - Area under concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
1443198|NCT00910663|Primary|AUC0-inf|Bioequivalence based on AUC0-inf - Area under concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
1443199|NCT00910663|Primary|Cmax|Bioequivalence based on Cmax - Maximum Drug Concentration|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
1443200|NCT00910624|Secondary|Percentage of Participants With Early Virologic Response (EVR)|EVR was defined as undetectable HCV-RNA at TW 12 of BOC + PEG/RBV. EVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From TW 1 to TW 12|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."|||percentage of participants|||Number
1443201|NCT00910624|Primary|Percentage of Participants With Adverse Events (AEs) Leading to Dose Modification (DM) or Discontinuation (DC), Treatment-Related Serious AEs (SAEs), Neutrophil Count <0.75 × 10^9/L, or Hemoglobin (Hgb) <10 g/dL|AE= any untoward medical occurrence in a participant administered a pharmaceutical product/biologic (at any dose), whether or not considered related to the use of that product. Included the onset of new illness and the exacerbation of pre-existing conditions. Clinically significant laboratory abnormalities that required intervention/additional therapy, required a dose modification, or were associated with a clinical manifestation were considered AEs. SAE= any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, or was a congenital anomaly or birth defect.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through FW 24 (up to 68 weeks)|All Treated Participants: All enrolled participants who received at least one dose of treatment.|||percentage of participants|||Number
1443202|NCT00910624|Primary|Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24);|SVR24 was defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) at Follow-up Week (FW) 24. SVR rates were evaluated by the prior interferon response (e.g., log drop from baseline at TW 4 or TW 12) in the previous studies.|From start of 4-week PEG/RBV lead-in therapy or 44-week BOC/PR treatment through Follow-Up Week (FW) 24 (up to 68 weeks)|"All BOC-Treated Participants: All enrolled participants who received at least 1 dose of BOC. Data for 2 Other participants were included in the calculations for BOC + PEG/RBV: All  (n=164). 4 discontinued during the 4-week PEG/RBV lead-in and did not receive BOC and thus were excluded from analysis."|||percentage of participants|||Number
1443203|NCT00910520|Secondary|Change From Baseline in Volume Voided Per Micturition|The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||milliliters||Standard Deviation|Mean
1443204|NCT00910520|Secondary|Change From Baseline in Number of Daily Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||micturition episodes||Standard Deviation|Mean
1443205|NCT00910520|Primary|Change From Baseline in Number of Daily Episodes of Urinary Incontinence|A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Baseline, Week 12|Intent-to-treat population included all randomized patients.|||Incontinence episodes||Standard Deviation|Mean
1443206|NCT00910299|Secondary|Number of Participants With Composite Endpoint of All-Cause Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of all-cause death or MI.|Baseline through 6 months|Participants who were randomized.|||participants|||Number
1443207|NCT00910299|Secondary|Number of Participants With Stent Thrombosis (ST)|Academic Research Consortium (ARC) criteria was used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause.|Baseline through 6 months|Participants who were randomized.|||participants|||Number
1443208|NCT00910299|Primary|Number of Participants With Composite Endpoint of Cardiovascular Death or Myocardial Infarction (MI)|The endpoint in this measure is a combination of cardiovascular death or MI.|Baseline through 6 months|Participants who were randomized.|||participants|||Number
1443209|NCT00910273|Secondary|Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52|Chest expansion defined as the difference in thoracic circumference during full expiration versus full inspiration, measured in cm at the fourth intercostal space (nipple line) while participant was standing. Measurement taken twice and best of the two measurements (corresponding to the highest value of inspiration and smallest value for expiration), were then averaged. Greater chest circumference indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; Due to limited number of participants with visits after Week 12 analysis limited to Week 12|||cm||Standard Deviation|Mean
1443210|NCT00910273|Secondary|Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52|While participant stood with back against the wall and during maximal effort to touch head to the wall, the distance between the occiput (back of head) and the wall was measured. The measurement of two attempts was made and best of the two measurements which corresponds to the highest value were reported. Lower scores indicated improvement in spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
1443211|NCT00910273|Secondary|Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between participant's middle fingertip and the floor after bending sideways, without bending knees or lifting heels, while attempting to keep shoulders in same place (flexion position). Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
1443212|NCT00910273|Secondary|Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between the tragus and wall from the right and left side while participant was standing with back against the wall; knees straight; scapulae, buttocks, and heels against the wall; with head in a neutral position. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the smallest value), were then averaged. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
1443213|NCT00910273|Secondary|Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52|Measurement in cm of distance between marks originally placed while participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joins the posterior superior iliac spines. Distance between marks was re-measured with participant maximally bent forward, knees fully extended, with supine in full flexion. The measurement was carried out two times and best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
1443214|NCT00910273|Secondary|Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52|Measurement in cm of the distance between the medial malleoli when participant was lying supine with knees straight and feet pointed straight up with legs separated as far as possible, 2 attempts were measured. The best of the two measurements which corresponds to the highest value were reported. Higher score indicated greater spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point|||cm||Standard Deviation|Mean
1443215|NCT00910273|Secondary|Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52|While in a neutral position, the participant turned the head as far as possible to the right and then to the left. Using a goniometer the degrees of movement were measured. Two measurements on the right and 2 on the left were made. The best of the two measurements for each side (corresponding to the highest value), were then averaged. Higher score indicated greater spinal mobility. Actual rotation ranged from 3.0 to 99.0 degrees. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, 52 or ET|mITT; n= number of participants evaluable at specific time point|||degrees of movement||Standard Deviation|Mean
1443239|NCT00910247|Secondary|Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).|One year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentage of participants|||Number
1443216|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. Lower score indicated better spinal mobility. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point|||Units on a scale||Standard Deviation|Mean
1443217|NCT00910273|Secondary|Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52|Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
1443218|NCT00910273|Secondary|Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
1443219|NCT00910273|Secondary|Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
1443220|NCT00910273|Secondary|Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants with evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
1443221|NCT00910273|Secondary|Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 mm scale (0 mm = no disease activity, 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
1443222|NCT00910273|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change greater than or equal to (≥) 10 units on a 0-100 millimeter (mm) scale (0 mm = no disease activity; 100 mm = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|Week 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
1443223|NCT00910273|Secondary|Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52|BASDAI a validated self assessment tool used to determine disease activity in participants with AS. Utilizing a VAS of 0 (none) to 10 cm (very severe), participant's answered 6 questions measuring discomfort, pain and fatigue. BASDAI 50 response defined as at least a 50% improvement (decrease) from baseline in BASDAI. Baseline score – score at observation divided by Baseline score * 100 = greater than or equal to 50%.|Weeks 4, 12, 24, 36, and 52 or ET|mITT; N=number of participants evaluable; n=number of participants evaluable at specific time point|||percentage of participants|||Number
1443224|NCT00910273|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52|BASDAI a validated self assessment tool to determine disease activity in participant with Ankylosing Spondylitis (AS) using a Visual Analog Scale (VAS) of 0 (none) to 10 (very severe) centimeter (cm). Participant answered 6 questions measuring discomfort, pain and fatigue. Final BASDAI score averages the individual assessments for a final score range of 0-10. Change: Week x observation minus Baseline observation. Higher score indicates greater disability. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36, and 52 or ET|mITT; n= number of participants evaluable at specific time point|||Units on a scale||Standard Deviation|Mean
1443225|NCT00910273|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52|CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point|||mg/liter (mg/L)||Standard Deviation|Mean
1443240|NCT00910247|Secondary|Change in Seizure Frequency From Baseline.|Relative (%) change in standard seizure frequency(SSF) from baseline|Month 12 from baseline|Intent-to-treat (ITT) population consisted of all subjects who had taken any open-label study medication|||percent change||Inter-Quartile Range|Median
1443226|NCT00910273|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour (hr). A higher rate is consistent with inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; N=number of participants evaluable; n= number of participants evaluable at specific time point|||mm/hr||Standard Deviation|Mean
1443227|NCT00910273|Secondary|Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52|Mean serum homocysteine blood concentrations. Lower values of homocysteine indicate improvement in inflammation. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n= number of participants evaluable at specific time point; N=number of participants evaluable|||micromole/liter (µmol/L)||Standard Deviation|Mean
1443228|NCT00910273|Secondary|Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52|Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and Triglyceride (TGL) blood concentrations, lower values indicated improvement in cardiovascular risk. Mean High Density Lipoprotein (HDL), higher values indicated improvement in cardiovascular risk. Change: Week x observation minus Baseline observation. Baseline value was used when present, otherwise valid screening value used as baseline if within 14 days of first test article injection.|Baseline, Weeks 4, 12, 24, 36 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable|||millimole/Liter (mmol/L)||Standard Deviation|Mean
1443229|NCT00910273|Secondary|Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52|Change in IMT in the distal common carotid arteries (CCA), common bulbs (CB), and internal carotid arteries (ICA) as determined by ultrasound. Higher scores indicate worsening in cardiovascular risk assessment. Change: Week x observation minus Baseline observation.|Baseline, Week 12 and 52 or ET|mITT; n=number of participants evaluable at specific time point; N=number of participants evaluable|||mm||Standard Deviation|Mean
1443230|NCT00910273|Secondary|Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52|BA FMD =(maximum diameter -baseline diameter divided by baseline diameter) * 100%. Ultrasound images of BA at rest were followed by BP cuff inflated to at least 50 mm Hg above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function. Change: Week x observation minus Baseline observation.|Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)|mITT; n=number of participants evaluable at specific time point|||percentage of BA diameter||Standard Deviation|Mean
1443231|NCT00910273|Primary|Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12|Brachial artery (BA) FMD equals (=)(maximum diameter minus[-] baseline diameter divided by baseline diameter) times (*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.|Baseline, Week 12|Modified Intent to Treat Population (mITT): all randomized participants who received at least one dose of test article followed by at least one available evaluation; n=number of participants evaluable at specific time point|||percentage of BA diameter||Standard Deviation|Mean
1443232|NCT00910247|Secondary|Completion Rate (% of Subjects Completing Each Visit Post-one Year).|Completion rate (% of subjects completing each visit post-one year).|post 1 year|The intent-to-treat (ITT) subjects who entered the post - 1- year open -label period.|||percentagae of participants|||Number
1443233|NCT00910247|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening|The total score of MADRS is defined as the sum of all individual item scores . Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.|baseline and Month 12|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||units on a scale||Standard Deviation|Mean
1443234|NCT00910247|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).|The total score of MADRS is defined as the sum of all individual item scores. Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||units on a scale||Standard Deviation|Mean
1443235|NCT00910247|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|"Change in the overall score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31 )~The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life."|baseline and Month 12|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||units on a scale||Standard Deviation|Mean
1443236|NCT00910247|Secondary|Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)|The retention time is defined from the start of eslicarbazepine acetate monotherapy period in 093-045 or 093-046 to the last known dose of open-label eslicarbazepine acetate. The time may include taking eslicarbazepine acetate concomitantly with other anti-epileptic drugs. If a subject’s termination reason(s) includes: withdrawal of consent, lost to follow-up, physician decision or other, then it was assumed the subject terminated the study due to lack of efficacy.|One year|Intent-to-treat (ITT) subjects who started the monotherapy period in 093-045 or 093-046 (visi t6/week 8)|||days||95% Confidence Interval|Median
1443237|NCT00910247|Secondary|Completion Rate (% of Subjects Completing the One Year Treatment)|Completion rate (% of subjects completing the one year treatment)|One year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentagae of participants|||Number
1443241|NCT00910247|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other anti-epileptic drugs while taking study medication. Time on eslicarbazepine acetate monotherapy is defined from the date of the first monotherapy dose in 093-045 or 093-046 study to the last known dose of monotherapy treatment, regardless of dose change and the time gap between the parent studies and the current study.|One year|ITT Subjects who started the monotherapy period (Visit 6/Week 8) in 093-045 or 093-046 and did not add a non-rescue/emergency Antiepileptic drug (AED) during the start date of the monotherapy period|||Days||95% Confidence Interval|Median
1443242|NCT00910247|Secondary|Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).|"The C-SSRS is an instrument designed to systematically assess and track suicidal behavior and suicidal ideation. The C-SSRS will be completed by the Investigator or Sub-Investigator (or qualified site personnel).~Suicidal ideation is collected as any occurrence of wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with specific plan and intent.~Suicidal behavior is collected as any occurrence of actual attempts, Non-Suicidal Self-Injurious Behavior, interrupted attempts, aborted attempts, or preparatory acts or behavior, suicidal behavior.~Any suicidality is defined as having at least one occurrence of Suicidal Behavior or Suicidal Ideation."|1 year|The Intent-to-Treat (ITT) population consisted of all subjects that received any open-label study medication|||percentage of events|||Number
1443243|NCT00910247|Secondary|Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.|"Number and percentage of subjects by QT interval corrected using the Fridericia fomula (QTcF) categories~Based on the numbers of subjects who had at least one post-baseline assessment, the number and percentage of subjects with QTcF values in the following categories were summarized:~>500 millisecond (msec) at any post-baseline timepoint but not present at baseline~>480 msec at any post-baseline timepoint but not present at baseline~>450 msec at any post-baseline timepoint but not present at baseline~Change from Baseline >=60 ms for at least one post-baseline measurement~Change from Baseline >=30 ms for at least one post-baseline measurement and <60 ms for all post-baseline measurement~QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle."|Baseline, Month 12|The intent-to-treat (ITT) subjects with at least one post-baseline assessment|||Participants|||Count of Participants
1443244|NCT00910247|Secondary|Number and Percentage of Subjects With Orthostatic Effects.|Number and percentage of subjects with orthostatic effects.|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||Participants|||Count of Participants
1443245|NCT00910247|Secondary|Percentage of Subjects With Increase of Body Weight ≥7%|Percentage of subjects with increase of body weight ≥7%|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||percentagae of participants|||Number
1443246|NCT00910247|Secondary|Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Number and percentage of subjects who had normal sodium value (i.e. >135 mEq/L) at baseline but reached <=135 mEq/L and >130 mEq/L, <=130 mEq/L and >125 mEq/L, or <=125 mEq/L at any post baseline.|1 year|ITT subjects with baseline sodium and at least one post baseline sodium value|||Participants|||Count of Participants
1443247|NCT00910247|Secondary|Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations|Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations|1 year|The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.|||Participants|||Count of Participants
1443248|NCT00910247|Primary|Number and Percent of Subjects With Treatment Emergent Adverse Events|Number and percent of subjects with treatment emergent adverse events|One year|The Intent-to -Treat (ITT) population consisted of all subjects who had taken any open-label study medication|||Participants|||Count of Participants
1443249|NCT00910091|Secondary|Progression Free Survival (PFS): Time From Randomisation Until Objective Tumour Progression or Death From Any Cause||Up to 2 years||||Weeks||90% Confidence Interval|Median
1443250|NCT00910091|Secondary|Overall Survival (OS)|OS is defined as the time from the date of enrollment to the date of death due to any cause.|At 2 years|ITT population.|||Weeks||90% Confidence Interval|Median
1443251|NCT00910091|Secondary|Duration of Response (DR) in Responders|DR is defined as period from the time that measurement criteria are first met for CR or PR until first date of documented Progressive Disease (PD) or death. DR was assessed in participants with a best overall response of CR or PR.|At 2 years|ITT population.|||Weeks||90% Confidence Interval|Median
1443252|NCT00910091|Secondary|Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation||Up to 2 years|ITT population.|||Percentage of Participants||Standard Deviation|Mean
1443253|NCT00910091|Secondary|Percentage of Participants With Overall Response (OR) Including CR and PR||Up to 2 years|ITT population.|||Percentage of Participants||Standard Deviation|Mean
1443254|NCT00910091|Secondary|Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks|"CR: Disappearance of all known disease & no new sites / disease related symptoms confirmed at least 12 weeks after initial documentation. Disappearance of all non-target lesions. Normalization of tumor marker level confirmed at least 12 weeks after initial documentation.~PR: Minimum 30% decrease in sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 12 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Up to 2 years|ITT population.|||Percentage of Participants||Standard Deviation|Mean
1443388|NCT00909610|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443255|NCT00910091|Secondary|Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is a participant answered questionnaire scoring 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.|Up to week 32|"ITT population.~Three subjects withdrawn the consent from MA 160 mg group and did not have EuroQoL score up to week 32."|||Percentage of participants|||Number
1443256|NCT00910091|Secondary|Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions|Percentage of participants who had dose interruptions and reason for interruptions as AE, study treatment forgotten, and other reasons.|Up to 2 years|Safety Population|||Percentage of participants|||Number
1443257|NCT00910091|Secondary|Tolerability of BN83495 Based on Cumulative Dose Administered|Cumulative dose is the actual total dose administered.|Up to 2 years|"Safety Population~Missing number of subjects = 2"|||mg||Standard Deviation|Mean
1443258|NCT00910091|Secondary|Tolerability of BN83495 Based on Length of Exposure|Length of exposure includes interruptions.|Up to 2 years|Safety Population|||Week||Standard Deviation|Mean
1443259|NCT00910091|Secondary|Percentage of Participants With Adverse Event (AE)|Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening/disabling and Grade 5: Death|Up to Day 28 follow-up|Safety Population: All randomised subjects who received at least one dose of study medication.|||Percentage of subjects|||Number
1443260|NCT00910091|Primary|Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died|Subject continuation in the study and Response Evaluation Criteria in Solid Tumours (RECIST) assessment has been based on investigator assessment and not on central review. The 6 month timepoint is defined as the treatment start date +183 days (26 weeks).|Up to 6 months|Intent-to-treat (ITT) population includes all randomized subjects who received at least one dose of study medication.|||Percentage of subjects||90% Confidence Interval|Number
1443261|NCT00910039|Secondary|Safety and Tolerability|Number of patients that experienced treatment-related G 3-4 adverse events.|3 years from study start||||participants|||Number
1443262|NCT00910039|Secondary|Neurocognitive Effects|The number of patients that had statistically significant change (p’s > 0.05) in their neurocognitive assessment (improvement or decline) from baseline. Neurocognitive function was assessed in several domains, including memory, verbal fluency, visual-motor speed, executive function and motor dexterity.The difference between the pre-treatment baseline and follow-up assessment scores were determined by the reliable change (RC) index. RC Index: 1=deterioration, 2=no change, 3=improved|at 2 months after treatment|Due to the small number of patients accrued there was not enough data for analysis of this outcome.||||||
1443263|NCT00910039|Secondary|Rate of Local Failure at 12 Months|Rate of local vs regional failure –rates of progression at site of stereotactic radiosurgery (local failure)vs progression anywhere else in CNS (regional failure).|12 months|Due to the small number of patients accrued there was not enough data for analysis of this outcome.||||||
1443264|NCT00910039|Secondary|Time to Progression|Time to progression (all sites of disease) - interval between stereotactic radiosurgery and the earliest date of progression (systemic or CNS) or death due to any cause.|at 3 yrs from SRS||||months||95% Confidence Interval|Median
1443265|NCT00910039|Secondary|Overall Survival|The number of subjects surviving at least 12 months from stereotactic radiosurgery.|12 months from SRS|Intent to treat|||participants|||Number
1443266|NCT00910039|Secondary|Median Time to CNS Disease Progression|Time to disease progression will be recorded from the first day of protocol therapy until the criteria for disease progression are met, patient death from any cause or removal of the patient from study for any reason, whichever comes first.|up to12 months from SRS|Intent to treat|||months||95% Confidence Interval|Median
1443267|NCT00910039|Secondary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least 12 months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald’s standard criteria. Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|12 months after stereotactic radiosurgery (SRS)|Intent to treat|||participants|||Number
1443268|NCT00910039|Primary|Central Nervous System (CNS) Progression-free Survival Rate|The number of subjects surviving at least six months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald’s standard criteria.Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.|6 months after stereotactic radiosurgery (SRS)|Intent to treat|||participants|||Number
1443269|NCT00910000|Secondary|Response|Response was based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD from the smallest LD recorded on treatment. Stable disease (SD) is neither sufficient increase to qualify as PD nor sufficient shrinkage to qualify for PR. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed 4 weeks +/- 2 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Participants who received therapy but did not have their disease re-evaluated were considered unevaluable.|Disease was assessed radiographically (CT or MRI scan) every 2 cycles on treatment; Phase Ib participants received up to 8 cycles of treatment. The median number of cycles started was 2 (range 1-8).||||participants|||Number
1443298|NCT00909857|Secondary|Own Costs of Massages Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443270|NCT00910000|Primary|Dose Limiting Toxicity (DLT) [Phase Ib]|"Dose-limiting toxicity was based on the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) and defined as any of the following:~Any CTCAE grade 3 or 4 non-hematologic event except manageable gastrointestinal toxicity and fatigue.~Any of the following hematologic events (excluding neutropenia lasting < 5 days):~i) febrile neutropenia defined as grade 3-4 neutropenia with fever ≥ 38.5°C and/or infection.~ii) any grade 4 neutropenia lasting 5 days or more. iii) grade 4 thrombocytopenia (plt count < 25x 109/L) iv) failure of ANC to recover to ≥ 1000/μL or platelets to recover to ≥ 50,000/μL within 14 days of therapy v) grade 4 anemia~Any clinically significant abnormal laboratory value that results in dose delay of >14 days.~<75% of vorinostat dosing taken by the patient during the first cycle due to any toxicity."|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, DLT evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final DLT dataset was comprised of all enrolled and treated participants.|||participants with DLT|||Number
1443271|NCT00910000|Primary|Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]|The Vorinostat MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached.|The DLT observation period in determining the MTD was the 21-day cycle 1 length.|Per protocol, MTD evaluable participants received day 1 of treatment, were not taken off study during cycle 1 due to disease progression, showed proof via pill diary that all doses of vorinostat were taken or attempted to be taken and were compliant with study procedures. The final MTD dataset was comprised of all enrolled and treated participants.|||mg/day|||Number
1443272|NCT00909870|Other Pre-specified|Complete Healing by Week 16: Ulcers <= 12 Months Duration||16 weeks|Pre-specified Subgroup of the Intent-to-Treat Population|||participants|||Number
1443273|NCT00909870|Secondary|Time-to-Complete Healing|Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.|From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject’s ulcer not healed at 16 weeks, the “time until CH” was censored at 112 days.|Intent-to-Treat population|||days||Inter-Quartile Range|Median
1443274|NCT00909870|Primary|Complete Healing of the Study Ulcer by Week 16.||16 weeks|Intent-to-Treat population|||participants|||Number
1443275|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443276|NCT00909857|Secondary|Bodily Pain as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443277|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443278|NCT00909857|Secondary|Role Emotional as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443279|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443389|NCT00909610|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443280|NCT00909857|Secondary|Role Physical as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443281|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443282|NCT00909857|Secondary|General Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443283|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443284|NCT00909857|Secondary|Vitality as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443285|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443286|NCT00909857|Secondary|Mental Health as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants wit assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443287|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443299|NCT00909857|Secondary|Own Costs of Vitamins Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443288|NCT00909857|Secondary|Social Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443289|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Final Examination|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|at final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443290|NCT00909857|Secondary|Physical Functioning as Measured by General Health and Well-being Questionnaire SF-36 at Baseline Cycle|The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome)|At baseline cycle (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443291|NCT00909857|Secondary|Participants With Improvement in Participants' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Participants were asked to rate their improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Participants|||Number
1443292|NCT00909857|Secondary|Participants With Improvement in the Investigators' Assessment in the Clinical Global Impression|The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women’s health in particular. Investigators were asked to rate the participants' improvement during the course of the study.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Participants|||Number
1443293|NCT00909857|Secondary|Other Own Costs Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443294|NCT00909857|Secondary|Own Costs of Herbs/Teas Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443295|NCT00909857|Secondary|Own Costs of Alternative Medicine Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443296|NCT00909857|Secondary|Own Costs of Medical Counseling Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443297|NCT00909857|Secondary|Own Costs of Acupuncture Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443300|NCT00909857|Secondary|Own Costs of Pain Medication Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443301|NCT00909857|Secondary|Own Costs of Physiotherapy Per Treatment Converted to U.S. Dollars as Measured by Resource Use Questionnaire|The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars.|At screening (average over 3 months before screening)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Dollars||Full Range|Median
1443302|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Final Examination|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At final examination (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
1443303|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Cycle 2|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At cycle 2 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
1443304|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Baseline Cycle|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At Baseline (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
1443305|NCT00909857|Secondary|Percentage of Participants Missing Time From Work Due to Dysmenorrheic Pain at Screening|The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle.|At screening (28 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available|||Percentage of Participants|||Number
1443306|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of participants|||Number
1443307|NCT00909857|Secondary|Percentage of Participants With Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of participants|||Number
1443308|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443354|NCT00909844|Secondary|Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test|A suppressed FSH response to the GnRH test was defined as a stimulated peak of FSH ≤3 IU/L. Percentage of patients who had a suppressed FSH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0 and 36|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||percentage of patients||95% Confidence Interval|Number
1443309|NCT00909857|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443310|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443311|NCT00909857|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443312|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1443313|NCT00909857|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1443314|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 3|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
1443315|NCT00909857|Secondary|Percentage of Participants With Intracyclic Bleeding at Cycle 1|Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
1443316|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443390|NCT00909545|Secondary|Common Adverse Events: Hypotension|Vascular Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443317|NCT00909857|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443318|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443319|NCT00909857|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443320|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443321|NCT00909857|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443322|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 3|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
1443323|NCT00909857|Secondary|Percentage of Participants With Withdrawal Bleeding at Cycle 1|Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal.|At cycle 1 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of Participants|||Number
1443324|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Spotting Only Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443391|NCT00909545|Secondary|Common Adverse Events: Back Pain|Musculoskeletal and Connective Tissue Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443985|NCT00904826|Secondary|Change in Expanded Disability Status Scale (EDDS) Score|The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments.|baseline, 12 months||||units on a scale||95% Confidence Interval|Mean
1443325|NCT00909857|Secondary|Maximum Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443326|NCT00909857|Secondary|Mean Length of Spotting Only Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443327|NCT00909857|Secondary|Number of Episodes With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1443328|NCT00909857|Secondary|Number of Days With Spotting-only|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443329|NCT00909857|Secondary|Difference in Duration Between Longest and Shortest Bleeding or Spotting Episode|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443330|NCT00909857|Secondary|Maximum Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443331|NCT00909857|Secondary|Mean Length of Bleeding or Spotting Episodes|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443355|NCT00909844|Secondary|Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA)|Mean levels of oestradiol in girls or testosterone in boys are reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 36 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
1443986|NCT00904826|Secondary|Number Subjects Experiencing an NMO Attack in 12 Months of Eculizumab Treatment||12 months||||participants|||Number
1443332|NCT00909857|Secondary|Number of Episodes With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1443333|NCT00909857|Secondary|Number of Days With Bleeding or Spotting|Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject’s experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting.|From day 1 to day 90|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443334|NCT00909857|Secondary|Percentage of Participants Satisfied With Study Treatment|Participants were asked to express the degree of their satisfaction with study treatment.|From cycle 1 to cycle 3 (28 days per cycle)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Percentage of participants|||Number
1443335|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Entire Evaluation Period Used)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available|||Percentage of Participants|||Number
1443336|NCT00909857|Secondary|Percentage of Participants With Interference of Dysmenorrheic Pain With Work/School and Social or Other Activity (Only Bleeding Episodes Used Including the Two Days Before)|Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available|||Percentage of participants|||Number
1443337|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Entire Evaluation Period Used)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
1443338|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Rescue Medication Use (Only Bleeding Episodes Used Including the Two Days Before the Episode)|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
1443356|NCT00909844|Secondary|Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test|A suppressed LH response to the GnRH test was defined as a stimulated peak of LH ≤3 international units per litre (IU/L). Percentage of patients who had a suppressed LH response to the GnRH test is reported. It should be noted that almost no hormonal data was collected after Baseline; all data analysed is presented.|Months -6, 0 and 36|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||percentage of patients||95% Confidence Interval|Number
1443987|NCT00904826|Primary|Median Number of Neuromyelitis Optica (NMO) Attacks Per Year||baseline, after 12 months of treatment||||attacks per year||Full Range|Median
1443339|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain During Unscheduled Bleeding|Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443340|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in Number of Days With Pelvic Pain Independent of Occurrence of Vaginal Bleeding|Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443341|NCT00909857|Secondary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Sum of Score Points of Dysmenorrheic Pain|Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst)|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1443342|NCT00909857|Primary|Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain|Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period).|baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)|Full analysis set (FAS): all subjects admitted to the treatment phase who took at least 1 tablet of study medication or comparator, and for whom at least 1 observation after admission to treatment was available, all participants with assessment for this outcome measure|||Days||Standard Deviation|Mean
1443343|NCT00909844|Post-Hoc|Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6)|One secondary efficacy endpoint in this study was the percentage of children who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage at the end of the study. Results reported for this secondary endpoint applied the variable ‘Final Visit’ for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of children with regression or stabilisation of Tanner pubic hair pubertal stage was performed which applied the derived variable ‘Last Visit on Treatment’ for comparison to the Pretreatment stage. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.|Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.|||percentage of patients|||Number
1443344|NCT00909844|Post-Hoc|Percentage of Girls With a Stabilisation or Regression of Tanner Breast Pubertal Stage at the End of the Study (Last Visit on Treatment), Compared to Pretreatment (Month -6) and Baseline (Month 0)|One primary efficacy endpoint was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of girls maintaining a regression or stabilisation of sexual maturity (based on Tanner breast pubertal stage) until end of study. Results reported for this primary endpoint applied the variable ‘Final Visit’ for comparison to Pretreatment and Baseline. Since it was determined that the majority of patients had a Final Visit >3 months after their last injection, a post-hoc analysis of the percentage of girls with regression or stabilisation of Tanner breast pubertal stage was performed which applied the derived variable ‘Last Visit on Treatment’ to compare to the Pretreatment stage and to Baseline. This post-hoc analysis was judged to be appropriate since triptorelin pamoate 3-month formulation allows release of the active compound over 3 months and beyond this time, pubertal development is expected to progress.|Months 12, 24, 36, 48 and Last Visit on Treatment (if applicable; up to 51 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study.|||percentage of patients||95% Confidence Interval|Number
1443385|NCT00909610|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443345|NCT00909844|Secondary|Percentage of Children With a Stabilisation or Regression of Tanner Pubic Hair Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)|Pubic hair was measured by the Tanner method on a scale of 1 to 6. A low grade (i.e. 1) corresponds to a pre-pubertal stage and a high grade (i.e. 5 or 6) to an adult stage. Percentage of patients who had stabilisation or regression (no change in grade or a reduced grade) of Tanner pubic hair pubertal stage is reported. Study treatment was to last until the end of the therapeutic period; visits for Months 36 and 48 were optional because if the girl was already 11 and the boy already 13, they would have finished the study at a prior visit. The Final Visit was to occur only if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Please also note the additional post-hoc analysis for percentage of children with a stabilisation or regression of Tanner pubic hair pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.|Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study.|||percentage of patients||95% Confidence Interval|Number
1443346|NCT00909844|Secondary|Percentage of Girls With a Uterine Length < 36 Millimetres (mm)|Percentage of girls who had a uterine length < 36 mm are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36 and Final Visit (up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||percentage of patients||95% Confidence Interval|Number
1443347|NCT00909844|Secondary|Bone Age Maturation|Mean change in difference between bone age and chronological age from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||years||Standard Deviation|Mean
1443348|NCT00909844|Secondary|Predicted Adult Height SD Score|Mean change of predicted adult height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented. Also note that data for this endpoint was analysed for girls only.|Months -6, 0, 12 and Final Visit (up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
1443349|NCT00909844|Secondary|Auxological Parameters Variations: Weight Variation|Mean changes of weight from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||kg||Standard Deviation|Mean
1443350|NCT00909844|Secondary|Auxological Parameters Variations: Growth Velocity SD Score|Mean changes of growth velocity SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
1443351|NCT00909844|Secondary|Auxological Parameters Variations: Height SD Score|Mean changes of height SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
1443352|NCT00909844|Secondary|BMI Standard Deviation (SD) Score for Chronological Age Variation|Mean changes of BMI SD score from Pretreatment and from Baseline are reported. SD score is a standard term used in growth studies and represents standard deviations calculated as the patient value minus the mean divided by the SD. SD scores vary depending on the age and sex of the child. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||SD score||Standard Deviation|Mean
1443353|NCT00909844|Secondary|Body Mass Index (BMI) for Chronological Age Variation|Mean changes of BMI from Pretreatment and from Baseline are reported. It should be noted that only limited patient data was collected after Baseline; all data analysed is presented.|Months -6, 0, 12, 24, 36, 48 and Final Visit (up to 63 months)|Analysis performed on the ITT population, consisting of all enrolled patients who received at least one injection of study treatment in this follow up study. Only patients with data available at the timepoint of testing are reported.|||kilograms per metre squared (kg/m^2)||Standard Deviation|Mean
1443386|NCT00909610|Primary|AUC0-72 for Baseline Corrected Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443357|NCT00909844|Primary|Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0)|The primary objective was to assess efficacy of triptorelin pamoate 11.25 mg with respect to percentage of children maintaining a regression or stabilisation of sexual maturity (based on Tanner breast [girls] or genital [boys] pubertal stage) until end of study. Study treatment lasted until end of the therapeutic period; visits for Months 36 and 48 were optional since a child may have already finished the study at a prior visit. The Final Visit only occurred if the child did not end the study by a complete visit such as at Months 24, 36 or 48. Results are presented only for percentage of girls with regression or stabilisation of Tanner breast pubertal stage (n=34). Since only one boy was included in the study, results for this outcome measure were listed only and no statistical analysis was performed. Please also note additional post-hoc analysis for regression or stabilisation of Tanner breast pubertal stage which applied the variable Last Visit on Treatment instead of Final Visit.|Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)|Analysis performed on female patients in the ITT population, consisting of all enrolled female patients who received at least one injection of study treatment in this follow up study.|||percentage of patients||95% Confidence Interval|Number
1443358|NCT00909792|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.|||logMAR||Standard Deviation|Mean
1443359|NCT00909779|Secondary|Inspiratory Capacity (IC): Mean Change From Baseline|"IC: the total amount of air that can be drawn into the lungs after normal expiration.~IC was measured pre- and post-albuterol administration at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. IC maneuvers were done in triplicate. The mean of all recorded IC values was used for each subject at each time point. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last IC value obtained prior to first treatment dose was used for baseline."|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Least Squares Mean
1443360|NCT00909779|Secondary|Forced Vital Capacity (FVC): Mean Change From Baseline|Forced Vital capacity: the volume of air that can forcibly be blown out after full inspiration. Best FVC was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FVC from at least 3 acceptable maneuvers was recorded.|Baseline and on treatment at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Least Squares Mean
1443361|NCT00909779|Secondary|Percent Predicted FEV1: Mean Change From Baseline|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics (height, age, sex, and sometimes race and weight). Best FEV1 percent predicted was measured at Visit 1 (screening), pre-dose at baseline, months 3, 6, 9 and 12/EOS, as described for FEV1."|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Least Squares Mean
1443362|NCT00909779|Secondary|FEV1: Mean Change From Baseline|FEV1 was measured at Visit 1 (screening), pre- and post-albuterol administration for reversibility testing, pre-dose at baseline, months 3, 6, 9 and 12/EOS. The best FEV1 from at least 3 acceptable maneuvers was recorded. Study baseline was defined as the Visit 2 pre-dose value. If the Visit 2 pre-dose value was missing, the last FEV1 value obtained prior to first treatment was used for baseline.|Baseline and on treatments at months 3, 6, 9 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Liter||Standard Error|Mean
1443363|NCT00909779|Secondary|SGRQ: Mean Change From Baseline in Total Score|The SGRQ assessed health status and consisted of 3 component scores (Symptoms, Activity, and Impacts) as well as a total score. Items were scored in accordance with the developer’s guidelines. Scores were expressed as a percentage of overall impairment, where 100 represented worst possible health status and 0 indicated best possible health status. The SGRQ was assessed pre-dose at baseline, months 3, 6 and 12 or the end of study (EOS). Visit 2 was defined as baseline. A change from baseline in the Total Score of ≥ 4 units is considered the minimal clinically important difference (MCID) for SGRQ.|Baseline and on treatment at months 3, 6 and 12 (or early termination)|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Score||Standard Error|Least Squares Mean
1443364|NCT00909779|Secondary|The Incidence of Treatment Emergent AEs|"TEAEs were defined as: 1) adverse events that occurred on or after the date of first dose of study medication, 2) adverse events with a missing start date and a stop date on or after the date of first does of study medication, or 3) adverse events with both a missing start and stop date.~The frequency and percentage of subjects with TEAEs were summarized. At each level of summarization, a subject was counted only once for each AE he/she experienced within that level. The percentage of subjects having had at least 1 AE at each level was calculated."|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
1443365|NCT00909779|Secondary|The Incidence of All Cause Mortality|Survival status at the end of the study will be determined for each subject. The proportion of subjects dead and the annual event rate will be summarized by treatment.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
1443366|NCT00909779|Secondary|The Incidence of Protocol Defined COPD Exacerbations.|A protocol-defined exacerbation of COPD was defined as an increase in respiratory symptoms (classically, increased shortness of breath, increased sputum production, and/or increased sputum purulence) that necessitates any change in baseline medication other than bronchodilators (e.g., anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc) or causes the subject to require additional medical attention (i.e., emergency room visit or hospitalization).|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
1443367|NCT00909779|Primary|Time From Randomization to Respiratory Death or First COPD Exacerbation Related Hospitalization (Whichever Occurs First).|COPD exacerbation: an increase in COPD symptoms that necessitated any change in baseline medication (bronchodilators,anti-inflammatory agents, antibiotics, supplemental oxygen therapy, etc.).Hospitalization: any inpatient admission or any emergency department visit > 24 hours in duration. Hospice was considered hospitalization.COPD exacerbation related hospitalization: hospitalization that was due to 1) COPD exacerbation or 2) a COPD exacerbation preceded, or occurred concomitantly with the onset of, the event for which the subject was hospitalized.Respiratory-related death: For each death the Primary Investigator designated a ‘probable cause’, which was the primary condition that precipitated the terminal events that were the immediate cause of death. If a probable cause could not be ascertained, the cause of death was considered ‘UNKNOWN’. Cause other than ‘UNKNOWN’ was categorized as either respiratory or non-respiratory. Deaths of ‘UNKNOWN’ cause were counted as primary events.|0-12 months|Intent-to-treat population: subjects who were randomized to treatment and received at least 1 dose of study medication.|||Days|Participants|Standard Deviation|Mean
1443368|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443369|NCT00909753|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443370|NCT00909753|Primary|AUC0-72 for Total Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443371|NCT00909753|Primary|Cmax for Total Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443372|NCT00909753|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443373|NCT00909753|Primary|Cmax for Unconjugated Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443374|NCT00909753|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443375|NCT00909753|Primary|Cmax - Maximum Observed Concentration - for Total Ursodiol|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443376|NCT00909727|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||kilograms||Standard Error|Least Squares Mean
1443377|NCT00909727|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||millimoles per liter||Standard Error|Least Squares Mean
1443378|NCT00909727|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Through Week 24 and Week 48 (Respiratory Domain Score, Children)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||score on a scale||Standard Error|Least Squares Mean
1443379|NCT00909727|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||percent of predicted volume (L)||Standard Error|Least Squares Mean
1443380|NCT00909727|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo)and had available assessments during the time frame.|||percent of predicted volume (L)||Standard Error|Least Squares Mean
1443381|NCT00909649|Primary|Seroma Formation|the mean total drainage volume|within 30 days postoperative|ITT|||ml||Standard Deviation|Mean
1443382|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443383|NCT00909610|Primary|Cmax for Unconjugated Ursodiol - Baseline Corrected|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443384|NCT00909610|Primary|AUC0-72 for Unconjugated Ursodiol|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1443392|NCT00909545|Secondary|Common Adverse Events: Sinusitis|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443393|NCT00909545|Secondary|Common Adverse Events: Diarrhoea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443394|NCT00909545|Secondary|Common Adverse Events: Dyspepsia|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443395|NCT00909545|Secondary|Common Adverse Events: Insomnia|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443396|NCT00909545|Secondary|Common Adverse Events: Somnolence|Nervous System Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443397|NCT00909545|Secondary|Common Adverse Events: Depression|Psychiatric Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443398|NCT00909545|Secondary|Common Adverse Events: Upper Respiratory Tract Infection|Infections and Infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443399|NCT00909545|Secondary|Common Adverse Events: Nausea|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443400|NCT00909545|Secondary|Common Adverse Events: Fatigue|General Disorders and Administration Site Conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443401|NCT00909545|Secondary|Common Adverse Events: Constipation|Gastrointestinal Disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443402|NCT00909545|Secondary|Common Adverse Events: Headache|Nervous System disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443403|NCT00909545|Secondary|Common Adverse Events: Nasopharyngitis|Infections and infestations. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443404|NCT00909545|Secondary|Common Adverse Events: Dizziness|Nervous system disorders. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects. They will also be tabulated by treatment groups.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443405|NCT00909545|Secondary|Common Adverse Events: Oedema Peripheral|General disorders and administration site conditions. Common adverse experience/event is defined as AE occurs to 5(about 5%) or more subjects.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443406|NCT00909545|Secondary|Vital Signs: Change in Pulse Supine||Baseline to 12 months or the time to require dopaminergic therapy||||beats per minute||Standard Error|Least Squares Mean
1443407|NCT00909545|Secondary|Vital Signs: Change in Pulse Standing||Baseline to 12 months or the time to require dopaminergic therapy||||beats per minute||Standard Error|Least Squares Mean
1443408|NCT00909545|Secondary|Vital Signs: Change in Diastolic Supine||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
1443409|NCT00909545|Secondary|Vital Signs: Change in Diastolic Standing||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
1443410|NCT00909545|Secondary|Vital Signs: Change in Systolic Supine||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
1443411|NCT00909545|Secondary|Vital Signs: Change in Systolic Standing||Baseline to 12 months or the time to require dopaminergic therapy||||mm Hg||Standard Error|Least Squares Mean
1443412|NCT00909545|Secondary|Efficacy: Change in Parkinson Disease Quality of Life Questionnaire-39(PDQ-39)|The PD Quality of Life Scale(PDQ-39) asks the subject to evaluate how Parkinson disease has affected their health and overall quality of life at that point in time. The total quality of life scale includes subscales relating to social role, self-image/sexuality, sleep, outlook, physical function and urinary function. The outcome is defined as change in PDQ-39 between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. It is scored on a scale of zero to 100, with lower scores indicating better health and higher scores more severe disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443413|NCT00909545|Secondary|Efficacy: Change in Montreal Cognitive Assessment|The Montreal Cognitive Assessment(MoCA) is a brief 30-point screening instrument that was developed and validated to identify subjects with mild cognitive impairment. The outcome is defined as change in MoCA between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total MoCA score represents the sum of these 30-points, with a lower score indicating greater cognitive impairment. 30 is the maximum score, with a score of 26 or higher considered normal and below 26 indicative of Mild Cognitive Impairment.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443414|NCT00909545|Secondary|Efficacy: Change in Beck Depression Inventory II (BDI-II)|The Beck Depression Inventory (BDI) is a validated self-reported 21-item depression scale that was tested and validated as a reliable instrument for screening for depression in PD. The outcome is defined as change in BDI-II between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Total BDI score represents the sum of these 21-items. A higher change in score indicates a greater increase in disability. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443415|NCT00909545|Secondary|Efficacy: Change in Modified Schwab & England Independence Scale|The Schwab & England scale is an investigator and subject assessment of the subject's level of independence at all scheduled study visits. The subject will be scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to what he/she did before Parkinson's disease appeared. The outcome is defined as change in Schwab & England Independence Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. Higher decrease in score indicates higher disability. Score ranges from 100% (complete independence) to 0% (total disability).|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443416|NCT00909545|Secondary|Efficacy: Change in Modified Hoehn & Yahr Scale|The Modified Hoehn & Yahr Scale is an 8-level Parkinson's disease staging instrument. The outcome is defined as change in Modified Hoehn & Yahr Scale between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. A greater increase in stage indicates a greater increase in disability. Stage ranges from 0-5 (also including 1.5 and 2.5) with 0 indicating no disability and 5 indicating maximum disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443417|NCT00909545|Secondary|Efficacy: Change in Motor Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Motor subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part III) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part III: motor abilities at the time of the visit, consisting of 27 items (including 13 general questions and 14 sub-questions) each answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part III score represents the sum of these 27 items. A total of 108 points are possible. 108 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443418|NCT00909545|Secondary|Efficacy: Change in Activities of Daily Living(ADL) Subscale of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in ADL subscale of the Unified Parkinson's Disease Rating Scale(UPDRS Part II) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part II: Activities of Daily Living in the week prior to the designated visit, consisting of 13 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total Part II score represents the sum of these 13 questions. A greater increase in score indicates a greater increase in disability. A total of 52 points are possible. 52 represents the worst (total) disability), 0--no disability|Baseline to 12 months or the time to require dopaminergic therapy|All participants were included in the primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443419|NCT00909545|Secondary|Efficacy: Change in Mental Subscales of the Unified Parkinson's Disease Rating Scale|The outcome is defined as change in Mental subscale of Unified Parkinson's Disease Rating Scale(UPDRS Part I) between the baseline visit and month 12 or the time of sufficient disability to require dopaminergic therapy. UPDRS Part I: Mentation, behavior and mood, consisting of 4 questions answered on a 0-4 point scale where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score represents the sum of these 4 questions. A greater increase in score indicates a greater increase in disability. A total of 16 points are possible. 16 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|All participants were used in primary and secondary outcome analyses|||units on a scale||Standard Error|Least Squares Mean
1443420|NCT00909545|Primary|Tolerability of the Three Dosages(5mg, 10mg and 20mg) of Isradipine CR.|Tolerability will be judged by the proportion of subjects enrolled in a dosage group able to complete the 12 month study or to the time of initiation of dopaminergic therapy on their original assigned dosage. Tolerability of each active arm will be compared to placebo group.|Baseline to 12 months or the time to require dopaminergic therapy||||participants|||Number
1443421|NCT00909545|Secondary|Efficacy: Change in Unified Parkinson's Disease Rating Scale (UPDRS)|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 12 or the time to require dopaminergic therapy (last visit before subject goes on dopaminergic therapy), whichever occurs first. The UPDRS score has 4 components. Part I assesses mentation; Part II assesses activities of daily living; Part III assesses motor abilities; Part IV assesses complications of therapy. A total of 44 items are included in Parts I-III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Part IV contains 11 items, 4 of these items are scored 0-4 in the same manner, and 7 are scored 0-1, with 0 indicating the absence of impairment and 1 indicating the presence of impairment. Total UPDRS score represents the sum of these items in Parts I-IV. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability.|Baseline to 12 months or the time to require dopaminergic therapy|Participants are 99 subjects with early Parkinson disease not requiring dopaminergic therapy.|||Scores on a scale||Standard Error|Least Squares Mean
1443422|NCT00909532|Secondary|Absolute Change From Baseline in Weight at Week 24 and Week 48|As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.|baseline to 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||kilograms||Standard Error|Least Squares Mean
1443423|NCT00909532|Secondary|Time-to-first Pulmonary Exacerbation Through Week 24 and Week 48|Pulmonary exacerbation was defined as a change in antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of signs/symptoms such as change in sputum; new or increased hemoptysis; increased cough or dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees C; anorexia or weight loss; sinus pain/tenderness and discharge; change in physical examination of the chest; decreased pulmonary function by 10%; and radiographic changes indicative of pulmonary infection.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||proportion of event-free participants||95% Confidence Interval|Number
1443424|NCT00909532|Secondary|Absolute Change From Baseline in Sweat Chloride Concentration Through Week 24 and Week 48|The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..|||millimoles per liter||Standard Error|Least Squares Mean
1443425|NCT00909532|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score Through Week 24 and Week 48 (Respiratory Domain Score, Pooled)|The CFQ-R is a health-related quality of life measure for subjects with cystic fibrosis. Each domain is scored from 0 (worst) to 100 (best). A difference of at least 4 points in the respiratory domain score of the CFQ-R is considered a minimal clinically important difference (MCID).|baseline through 24 weeks and 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||score on a scale||Standard Error|Least Squares Mean
1443426|NCT00909532|Secondary|Absolute Mean Change From Baseline in Percent Predicted FEV1 Through Week 48|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 48 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame..|||percent of predicted volume (L)||Standard Error|Least Squares Mean
1443427|NCT00909532|Primary|Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|Spirometry (as measured by FEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies.|baseline through 24 weeks|All randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo) and had available assessments during the time frame.|||percent of predicted volume (L)||Standard Error|Least Squares Mean
1443428|NCT00909480|Secondary|"Number of Subjects Having the Adverse Event Incorrect Dose Administered"|"Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications"|Weeks 0-26|Safety Analysis Set: All subjects that received at least one dose of the trial product.|||Subjects|||Number
1443429|NCT00909480|Secondary|Change in Body Weight From Baseline||Week 0, Week 26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||kg||Standard Deviation|Mean
1443430|NCT00909480|Secondary|Hypoglycemic Episodes, Unclassifiable|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1443431|NCT00909480|Secondary|Hypoglycaemic Episodes, Nocturnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1443432|NCT00909480|Secondary|Hypoglycaemic Episodes, Diurnal|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1443433|NCT00909480|Secondary|Incidence of Hypoglycaemic Episodes During the Trial|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1443434|NCT00909480|Secondary|Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)|Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||mmol/L||Standard Deviation|Mean
1443435|NCT00909480|Secondary|Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast|The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||mmol/L||Standard Deviation|Median
1443436|NCT00909480|Secondary|Fasting Plasma Glucose (FPG)||Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||mmol/L||Standard Deviation|Mean
1443437|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage (%) of subjects|||Number
1443438|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%|The percentage of subjects – overall and by previous OAD treatment – meeting the HbA1c of 6.5% or less|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage (%) of subjects|||Number
1443439|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia|The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage (%) of subjects|||Number
1443440|NCT00909480|Secondary|Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%|The percentage of subjects – overall and by previous OAD treatment – meeting the HbA1c less than or equal to 7%|Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage of subjects|||Number
1443441|NCT00909480|Primary|Change in HbA1c From Baseline||Week 0, Week 26|Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.|||percentage point change||Standard Deviation|Mean
1443442|NCT00909428|Primary|Change in Maximal Cystometric Capacity (mL)|At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.|30 Days|The primary outcome analysis population comprises only women with two valid MCC recordings (i.e., one baseline recording and one recording following 30 days of treatment with daily 10mg solifenacin succinate. The groups DOI and USI were combined for this repeated measures analysis.|||milliliters (mL)||Inter-Quartile Range|Median
1443443|NCT00909389|Primary|Number of Participants Who Had an Adverse Event (AE).|"The objective of this study was to evaluate the overall safety and tolerability of Vytorin (R) Tablet (Ezetimibe+Simvastatin) when used in patients with hypercholesterolemia.~All AEs observed by or volunteered to the investigator during this observational study, regardless of suspected causal relationship, were to have been considered an AE."|Throughout study up to Day 29 (Final Visit)||||participants|||Number
1443444|NCT00909324|Secondary|Change in the Results of Schirmer’s Test From Baseline to End of Study|Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.|||mm||Standard Deviation|Mean
1443445|NCT00909324|Secondary|Change in Tear Breakup Time From Baseline to End of Study|The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.|||Seconds||Standard Deviation|Mean
1443446|NCT00909324|Primary|Change in Ocular Comfort Level From Baseline to End of Study|Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.|Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery|Intent-to-Treat population: All patients in the study who received study treatment.|||Units on a scale||Standard Deviation|Mean
1443447|NCT00909220|Primary|A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).|The negativity bias, characterized as the tendency to evaluate unpleasant versus pleasant information as more important, was measured using a computer task. Sitting in front of the computer, participants viewed emotionally evocative images and assigned their evaluations of how the intensity of these emotional images using a grid. The grid is comprised of a matrix, with 5 points on the horizontal axis representing the positivity seen in the image (0=not at all, 4 = extremely positive) by 5 points on a vertical axis representing the negativity seen in the image (0=not at all, 4 = extremely negative) matrix. The dimensional variable, negativity bias, is calculated as the difference in the mean ratings of very unpleasant images minutes the positive ratings of the very pleasant images. The Inventory of Depressive Symptomatology, Self-Rated (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity provided by the participant.|Weeks 0-16|First level units were 'weeks in BA treatment', with participants limited to those diagnosed with MDD and who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'MDD subjects entering treatment' (n = 41)|||slope||Standard Error|Geometric Least Squares Mean
1443448|NCT00909220|Primary|Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment|Frontal EEG asymmetry scores were calculated over the midfrontal sites, subtracting the natural log of the alpha power of the electrode in the left hemisphere (F3 or F7) from that of the right frontal electrode (F4 or F8), creating one summary alpha asymmetry variable. The absolute value of this difference score was taken. Using the natural log transformation is used in EEG asymmetry research as EEG power appears to be positively skewed. A higher score thus reflected greater relative left versus right frontal activation (e.g., relatively higher right alpha activity).|Week 0||||Alpha power||Standard Error|Mean
1443639|NCT00907153|Secondary|Change From Baseline in Mean LDL Cholesterol|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
1443449|NCT00909220|Primary|Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Patient-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.|The Inventory of Depressive Symptomatology, Self-Rated measure (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity completed by the participant. The item scores on this scale are summed to create a total score (range from 0 (no symptoms) to 84 (highest severity). The item scores on this scale are summed to create a total score (range from 0 (minimum score reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Severity of depression is reflected by total score (e.g., scores between 0-13 is interpreted as 'no depression', scores between 14-25 are interpreted as 'mild severity'; total scores between 26-48 are interpreted as 'severe', and total scores between '49-84' are interpreted as 'very severe'.|Week 16|Intent to treat sample.|||units on a scale||Standard Deviation|Mean
1443450|NCT00909220|Primary|Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Clinician-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.|The Inventory of Depressive Symptomatology-Clinician Rated measure (IDS-C; Rush, Giles, Schlesser, Fulton, Weissenburger, Burns, 1986; Rush, Carmody, & Reimitz, 2000; Rush, Trivedi, Ibrahim, Carmody, Arnow, Klein, et al., 2003) is a 30-item measure that reflects the presence and severity of DSM-IV symptoms of depression. The item scores on this scale are summed to create a total score. Scores range from 0 (minimum score, reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Scores between 0-11 are interpreted as 'no depression'; scores between 12-23 are interpreted as 'mild severity'; scores between 24-36 are interpreted as 'severe'; and total scores between '47-84' are interpreted as 'very severe'.|Week 16|Intent to treat sample.|||units on a scale||Standard Deviation|Mean
1443451|NCT00909181|Primary|Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12|Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.|12 weeks|mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment|||Episodes||Standard Deviation|Mean
1443452|NCT00909155|Primary|Functional Magnetic Resonance Imaging (fMRI) Response to an Emotional Regulation Task.|"Depressed participants were scanned while viewing a sequence of positive and negative images; they were instructed to enhance or supress their emotional response to the image or to continue to attend. To examine brain function when regulating negative affect, we created contrast maps for each participant at all 3 time points by subtracting the attend condition from the suppress condition in response to negative stimuli. Data from all 3 scan sessions were used to assess treatment-induced change in brain activity when regulating emotion. Analyses examining change using difference scores (end vs. starting points), we subtracted initial HAMD score from final HAMD score. For fMRI analyses, in a voxelwise manner, we subtracted initial negative suppress vs attend from final negative suppress vs attend.~Control subjects were not depressed, repeat scans to assess change were not completed.~Reported results are from BA10, one of our areas of interest."|At study entry, 2 months and end of study (6 months)|Depressed subjects were treated with an SSRI or an SNRI, and assessed at 3 time points on an fMRI emotional response task. Differences in depression scores and changes in the fMRI responses were analyzed for changes to better understand the association between emotion regulation, depression, and treatment response.|||fMRI signal change||Standard Deviation|Mean
1443453|NCT00909155|Primary|Hamilton Depression (HAM-D) and Anxiety (HAM-A) Rating Scales|"Hamilton Depression rating scale is a clinician assessment tool to measure severity of depression symptoms. Minimum score is 0 (no symptoms); maximum score is 52 (severe symptoms of depression).~Hamilton Anxiety rating scale is a clinician assessment tool to measure severity of anxiety symptoms. Minimum score is 0 (no symptoms); maximum score is 56 (severe symptoms of anxiety)."|Study entry, 2 months, and at end of study (6 mos)||||units on a scale||Standard Deviation|Mean
1443454|NCT00909064|Secondary|Incidence of Wound Infection|Incidence of Cellulitis in patients undergoing Arixtra treatment|Up to 10 days||||Participants|||Count of Participants
1443455|NCT00909064|Secondary|Number of Days in Hospital.|Days after surgery to dischage|Up to 10 days||||days||Standard Deviation|Mean
1443456|NCT00909064|Primary|Number of Days Until a Dry Wound|Days from day of surgery to stoppage of leakage from the wound|Up to 10 days||||days||Standard Deviation|Mean
1443457|NCT00909038|Secondary|Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007|The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.|Baseline to a minimum of 8 weeks of treatment|Per protocol set (PPS)|||percentage of patients|||Number
1443458|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mmHg||Standard Deviation|Mean
1443459|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mmHg||Standard Deviation|Mean
1443460|NCT00909038|Secondary|Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean DBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mm Hg||Standard Deviation|Mean
1443640|NCT00907153|Secondary|Change From Baseline in Mean HDL Cholesterol|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
1443461|NCT00909038|Secondary|Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population|Mean SBP measured at the Study End|baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||mm Hg||Standard Deviation|Mean
1443462|NCT00909038|Primary|Rate of BP Control in Hypertensive Patients|"Percentage of controlled Patients at the Study End.~Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines."|Baseline to a minimum of 8 weeks of treatment|Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.|||Percentage of Participants||95% Confidence Interval|Number
1443463|NCT00908960|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Assessed up to approximately 30 months|The analysis dataset is comprised of all evaluable patients.|||months||95% Confidence Interval|Median
1443464|NCT00908960|Secondary|Incidence of Major Hemorrhage Events|Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines. (Schulman and Kearon 2005)|Assessed during the 60 day therapy|The analysis dataset is comprised of evaluable patients.|||Participants|||Count of Participants
1443465|NCT00908960|Primary|2-Month Cumulative Incidence of VTE|2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.|Assessment with lower extremity ultrasound occured at day 60/ month 2|The analysis dataset is comprised of all evaluable patients.|||percent probability||95% Confidence Interval|Number
1443466|NCT00908908|Primary|Pharmacokinetics AUC (0-t) for Eribulin in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population|||ng eq*hr/mL/mg||Standard Deviation|Mean
1443467|NCT00908908|Primary|Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma|Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.|Between Days 1 and 8 of Cycle 1|Pharmacokinetic Population|||ng eq*hr/mL/mg||Standard Deviation|Mean
1443468|NCT00908908|Primary|Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.||312 hours postdose|Pharmacokinetic Population|||percent recovery||Standard Deviation|Mean
1443469|NCT00908895|Secondary|Range of Movement of Wrist|"Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.~Motion is described as a percentage of the opposite side."|6 months||||Percentage of opposite side||95% Confidence Interval|Mean
1443470|NCT00908895|Primary|The Grip Strength|Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.|6 months|No participant changed to the other group. Patients lost or with complications were not analyzed|||Percentage of opposite side||95% Confidence Interval|Mean
1443471|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 6-month follow-up period|These numbers represent those who completed the survey.|||units on a scale||Standard Deviation|Mean
1443472|NCT00908882|Secondary|Geriatric Depression Scale|range 1-15; >6 indicates depression|At the end of the 90-session intervention period|These numbers represent those that completed the survey.|||units on a scale||Standard Deviation|Mean
1443473|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At the end of the 6-month follow-up period|These numbers represent those that completed the survey.|||units on a scale||Standard Deviation|Mean
1443474|NCT00908882|Secondary|Post Traumatic Stress Disorder Checklist|range 17-85; >50 indicates PTSD diagnosis|At end of 90-session intervention period|These numbers represent those that completed the survey.|||units on a scale||Standard Deviation|Mean
1443475|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Are you currently a smoker?~Yes, I currently smoke (move to For Smokers Only section)~No, I quit within the last 6 months (ACTION STAGE)~No, I quit more than 6 months ago (MAINTENANCE STAGE)~No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?~(For smokers only) Are you seriously thinking of quitting smoking?~Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)~Yes, within the next 6 months (CONTEMPLATION STAGE)~No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During the 6-month follow-up period||||participants|||Number
1443476|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During the 6-month follow-up period||||participants|||Number
1443477|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During the 6-month follow-up period||||participants|||Number
1443478|NCT00908882|Primary|Seven-day Point Prevalence -A Primary Outcome is the Number of Veteran's Who Self-reported Quit Smoking for Seven Days.||During 90-session intervention period||||participants|||Number
1443813|NCT00905554|Secondary|Evaluation of Pain and Tolerability Scores|Entity of pain and tolerability level on a visual analogic scale (ranging from 0 - no pain, optimal tolerability - to 100 mm - worst pain ever, unbearable)|6-9 months||||Scores on a VAS scale||Inter-Quartile Range|Median
1443479|NCT00908882|Primary|Number of Participants Who Progressed Along the Stage of Change Toward Action as Measured by the Transtheoretical Model of Change (Short Form) Questionnaire. This Will Identify Current Stage of Change for Each Subject.|"Transtheoretical Model of Change questionnaire:~Are you currently a smoker?~Yes, I currently smoke (move to For Smokers Only section)~No, I quit within the last 6 months (ACTION STAGE)~No, I quit more than 6 months ago (MAINTENANCE STAGE)~No, I have never smoked (NONSMOKER) (For smokers only) In the last year, how many times have you quit smoking for at least 24 hours?~(For smokers only) Are you seriously thinking of quitting smoking?~Yes, within the next 30 days (PREPARATION STAGE if they have one 24-hour quit attempt in the past year - refer to previous question... if no quit attempt then CONTEMPLATION STAGE)~Yes, within the next 6 months (CONTEMPLATION STAGE)~No, not thinking of quitting (PRECONTEMPLATION STAGE)"|During 90-session intervention period||||participants|||Number
1443480|NCT00908882|Primary|Self-reported Quit Attempts - The Primary Outcome is the Number of Veteran's Who Make a Self-reported Quit Attempt (as Defined as a 24-hour Point Prevalence Rate).||During 90-session intervention period||||participants|||Number
1443481|NCT00908830|Secondary|Inter- and Intra-patient Variability of Mycophenolic Acid Exposure (AUC) in Cystic Fibrosis Lung Transplant Recipients on Tacrolimus Based Immunosuppression.|"Inter- and intra-patient variability will be calculated by the coefficients of variation (CV) of the MPA AUC (mg*h/L).~To analyze the intra- and interindividual variability, the coefficient of variation (CV) was calculated by dividing the standard deviation by the mean of the PK parameters from the 3 PK visits and the 5 study patients in each group, respectively. Inter-individual CVs presented are only comparing within the individuals per arm, not across or between arms."|0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose||||percent CV||Standard Deviation|Mean
1443482|NCT00908830|Primary|Steady-state Pharmacokinetics of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Stable Cystic Fibrosis and Non-Cystic Fibrosis Lung Transplant Recipients.|The AUC is the area under the concentration-time curve from time 0 to 12 hours. The AUC is measured in units of micrograms of mycophenolic acid (MPA) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg*h/L) and in units of micrograms of mycophenolic acid glucuronide (MPAG) per milliliter of plasma (mcg/mL) multiplied by time in hours (mg*h/L). Apparent oral clearance (CL/F) was calculated by dose/AUC0-12.|0 hours pre-dose and again at 0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours post-dose||||mg*h/L||Standard Error|Mean
1443483|NCT00908687|Other Pre-specified|Cross-clade HI Antibody Titer Measurement: Compare the Heterologous HI Antibody Responses to the A/Indonesia/05/2005 (Clade 2.1) Strain of the H5N1 Virus.||6 months|||||||
1443484|NCT00908687|Other Pre-specified|Adjuvanticity Evaluation: Compare HI Immune Responses Achieved by Antigen and Adjuvant Combinations With Antigen Alone Groups.||6 months|||||||
1443485|NCT00908687|Secondary|Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity|"The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40%~The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70%~Geometric mean titer (GMT) fold increase > 2.5"|Day 28|||||||
1443486|NCT00908687|Secondary|Safety of a 100μg LT Patch||6 months|||||||
1443487|NCT00908687|Secondary|Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch||6 months|||||||
1443488|NCT00908687|Primary|Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.|Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40.|Day 28|Primary Immunogenicity Evaluable Population (PIEP): all subjects who were consented, randomized, received the assigned treatment, had HI assay results at all the following time points: baseline (Day 0), Day 21 and Day 28, and did not have any major protocol deviations|||percentage of subjects||95% Confidence Interval|Number
1443489|NCT00908648|Secondary|Detection of Flat and/or Depressed Adenomas|number of patients with at least 1 flat and/or depressed adenoma|duration of colonoscopy procedure||||participants|||Number
1443490|NCT00908648|Primary|Adenoma Detection|Detection of adenoma, defined as the number of patients with > 1 adenoma, under White Light or NBI visualization|duration of colonoscopy procedure||||participants|||Number
1443491|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Characterization|The investigator was to record the imaging efficacy by evaluation of lesion characterization using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
1443492|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Delineation|The investigator was to record the imaging efficacy by evaluation of lesion delineation using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
1443493|NCT00908596|Secondary|Number of Participants With “Excellent / Good / Adequate / Insufficient” Scores for Lesion Detection|The investigator was to record the imaging efficacy by evaluation of lesion detection using a 4 point scale (Excellent / Good / Adequate / Insufficient). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
1443494|NCT00908596|Secondary|Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging)|The investigator was to record his / her confidence in making a diagnosis using a 4 point scale (Very high confidence / High confidence / Moderate / Low confidence). For some participants the values were not collected.|Immediately after Primovist/Eovist-enhanced MRI|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
1443641|NCT00907153|Secondary|Change From Baseline in Mean Total Cholesterol|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
1443495|NCT00908596|Secondary|Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score|Participants in whom no biopsy was obtained with a clinical score of 4 on a scale comprising 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
1443496|NCT00908596|Primary|Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information|A diagnosis of NSF was assumed for subjects with a minimum combined clinical (scale: 0-other diagnosis, 1-inconsistent, 2-suggestive, 3-consistent, 4-highly consistent) and histopathological score (same scale as clinical score). Either the clinical score or the histopathology score had to be at least 2, and the other at least 3.|Up to 24 months following the administration of Primovist/Eovist|Full Analysis Set: all participants who were enrolled and received Primovist/Eovist|||Participants|||Number
1443497|NCT00908583|Secondary|Acute Rejection Rate|Acute rejection rate at 6 months of all desensitized and transplanted patients|6 months post transplant|One graft loss occurred due to graft thrombosis within 24 hours (due to unrecognized hypercoagulability disorder without AMR). Two patients were transplanted at other centers and data was not available. This dropped the number of analyzed patients to 16 from 19.|||participants|||Number
1443498|NCT00908583|Secondary|Number of Patients Whose Cytotoxic Panel Reactive Antibody (PRA) is Decreased by 50%|Number of patients on the waiting list whose cytotoxic PRA is decreased by 50%.|46 days||||participants|||Number
1443499|NCT00908583|Primary|Number of Living Donor Transplant Candidates That Are Transplanted|Number of living donor transplant candidates who convert to a negative flow T- and B-cell crossmatch via desensitization and are subsequently transplanted|1 year post baseline||||participants|||Number
1443500|NCT00908583|Secondary|Overall Safety of Bortezomib|Incidence of grade 3 and above non-hematologic toxicities. Incidence of grade 4 hematologic toxicities. Incidence of all grades of peripheral neuropathy. Incidence of Cytomegalovirus (CMV), Polyomavirus Allograft Nephropathy (PVN), and Posttransplant Lymphoproliferative Disorder (PTLD).|Study Day 62||||participants|||Number
1443501|NCT00908466|Secondary|Change From Baseline VA by ETDRS||6 and 12 months|||||||
1443502|NCT00908466|Primary|Number of Participants With at Least 2-step Decrease in Vitreous Haze (VH)|Vitreous Haze is calculated using a 9 step photographic haze in uveitis patients using fundus photograph|6 months||||participants|||Number
1443503|NCT00908388|Primary|Exclusion of Primary Entry Tear|Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery|1 month||||participants|||Number
1443504|NCT00908388|Secondary|Additional Dissection Based Intervention Rate|Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.|Last available follow-up through 5 years||||participants|||Number
1443505|NCT00908388|Secondary|Aortic Rupture|Number of participants with thoracic aortic rupture|Last available follow-up through 5 years||||participants|||Number
1443506|NCT00908388|Secondary|False Lumen Thrombosis|Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.|Last available follow-up through 5 years|Participants with contrast-enhanced CT imagery performed during the specified follow-up period were included in this analysis|||participants|||Number
1443507|NCT00908388|Primary|All-cause Mortality Incidence Through 30 Days Post-treatment||30 Days Post-Treatment|All subjects were analyzed. One subject whose vital status could not be confirmed was included as a death in this analysis.|||participants|||Number
1443508|NCT00908375|Secondary|Oswestry Disability Questionnaires|"Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the percent disability. There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks."|3 weeks||||percent disability||Full Range|Median
1443509|NCT00908375|Secondary|Patient's Global Impression of Change at 3 Weeks|"Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:~Very Much Improved~Much Improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse"|3 weeks||||units on a scale||Full Range|Median
1443510|NCT00908375|Primary|Pain Scores (NRS) at 3-weeks|Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.|3 weeks||||units on a scale||Full Range|Median
1443511|NCT00908349|Primary|Percent Change in Seizure Rate|Measured as change from baseline to end of study|one year||||percentage of change in seizure rate||Full Range|Median
1443512|NCT00908310|Primary|Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).|Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.|Greater than or equal to 7 days post contrast administration.|Incidence of Nephrogenic Systemic Fibrosis (NSF)|||percentage of subjects||95% Confidence Interval|Number
1443513|NCT00908232|Secondary|Overall Survival|Is defined as the time interval from start of treatment to the date of death due to any cause. In the absence of confirmation of death (including subjects lost to follow-up), survival time will be censored at the last date the subject is known to be alive|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy. Further follow up by monthly phone call until the last patient was treated and followed for 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
1443514|NCT00908232|Secondary|One Year Survival|Percent Probability of Survival at 1 year from the start of treatment, estimated using Kaplan-Meier analysis.|At each visit from baseline to end of treatment. After treatment, monthly visit until progression or relapse or until the start of alternative MMY therapy, up to 1 year|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||percent probability||95% Confidence Interval|Number
1443515|NCT00908232|Secondary|Time to Progression|Is calculated as the time from start of treatment to the date of the first observation of disease progression or relapse from CR. Deaths owing to causes other than progression not counted, but censored. Subjects who withdraw from the study or die will be censored at the time of last disease assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), Median Follow-up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
1443516|NCT00908232|Secondary|Progression Free Survival|"Time from start of treatment to date of disease progression, relapse from CR or death. Estimated using the kaplan-meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR). Median Follow-Up of 16.9 months|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non-randomized CR/PR group, n=144. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
1443517|NCT00908232|Secondary|Median Time to First Confirmed Response|Time from start of treatment to the date of the first documentation of a confirmed response. Estimated using the Kaplan-Meier method. Response was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|At Day 1 of each treatment cycle, at the End of Treatment visit until there is evidence of Progressive Disease or relapse from Complete Response (CR), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. The non- randomized CR/PR group, n=144 for Time to First confirmed Response. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19).|||days||95% Confidence Interval|Median
1443518|NCT00908232|Primary|Overall Best Confirmed Response|Overall Best Confirmed Response is the best Overall Response Rate with borezomib-dexamathasone (+/-cyclophosphamide or lenalidomide) recorded between baseline and end of treatment. Response was assessed using the International Myeloma working Group (IMWG) Uniform Response Criteria and validated by an Independent Monitoring Committee.|Prior to treatment at day 1 of each cycle and at the end of treatment (day 21 of cycle 8), up to 168 days|mITT: All patients with at least 1 dose and 1 post baseline assessment. Low powered study because necessary sample size for the randomized part could not be reached. Thus, data were analyzed and reported by combining the randomized groups with SD, (n=19). Data are missing for 21 patients in the non-randomized CR/PR group, n=123.|||number of participants|||Number
1443519|NCT00908141|Primary|Prostate Specific Antigen (PSA) Response|The number of patients with PSA modulation defined as PSA decline of at least 50%|post treatment at 9 weeks||||participants|||Number
1443520|NCT00908128|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
1443521|NCT00908128|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
1443522|NCT00908128|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
1443523|NCT00908115|Primary|Number of Subjects Reporting Unsolicited Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) following vaccination.||||Subjects|||Number
1443524|NCT00908115|Primary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include induration, itching, pain, redness, and swelling.~Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting."|During the 4-week follow-up period after each dose|Analysis was performed on the subjects who received the considered dose.|||Subjects|||Number
1443525|NCT00908115|Primary|Number of Subjects Reporting Serious Adverse Events|"A serious adverse event is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Since the beginning of the study and during the entire study period (up to 6 years)||||Subjects|||Number
1443621|NCT00907335|Secondary|Change From Baseline in Lesion Counts|Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12||||Lesions||Standard Error|Least Squares Mean
1443526|NCT00908076|Primary|Change From Baseline to End of Study|Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student’s t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.|Baseline to end of study|"A marked or very marked clinical global improvement.~Ondo WG et al. Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease. Neurology 2012 May 22; 78:1650. - See more at: http://www.jwatch.org/jn201205290000006/2012/05/29/lubiprostone-constipation-parkinson-disease#sthash.ggWrS7Vq.dpuf"|||Percentage of participants|||Number
1443527|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Number of participants with a change in visual acuity and change in visual acuity due to the worsening of cataracts since Baseline are presented for Part 2/3 Follow-up Visits at 3-months (FU3) and 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|BL, 3 and 6mo Follow-up of Part 2/3|Safety Population: all subjects who have received at least one dose of the investigational product during Part 2/3 were analyzed.|||Participants|||Number
1443528|NCT00908037|Secondary|Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as yes or no. Change due to cataracts is categorized as yes or no."|Baseline, 3and 6-mo Follow-up of Part 1|Safety Population: all subjects who have received at least one dose of the investigational product during Part 1 were analyzed.|||Participants|||Number
1443529|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 31 of Part2/3|Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed|||Participants|||Number
1443530|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 7 of Part 2|Safety Population: all participants who received at least one dose of the investigational product during Part 2 were analyzed.|||Participants|||Number
1443531|NCT00908037|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Treatment + 1 day up to Week 24 of Part1|Safety Population: all participants who received at least one dose of the investigational product during Part 1 were analyzed.|||Participants|||Number
1443532|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 2/3 up to Study Week 31|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population|||Participants|||Number
1443540|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Baseline through Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population .|||Breaths per min||Standard Deviation|Mean
1443659|NCT00907088|Primary|The Primary Outcome is Iron Depletion, and Will be Defined as Serum Ferritin <10 mcg/L.||Age 24 months||||participants|||Number
1443533|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.|Baseline and Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population|||Participants|||Number
1443534|NCT00908037|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1|Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.|Baseline and Week 24 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.|||Participants|||Number
1443535|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population.|||Beats per minute||Standard Deviation|Mean
1443536|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Beats per minute||Standard Deviation|Mean
1443537|NCT00908037|Secondary|Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1|Pulse rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline (MPB) visit included any scheduled and unscheduled post-Baseline assessment..|From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population|||Beats per minute||Standard Deviation|Mean
1443538|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Breaths per minute||Standard Deviation|Mean
1443539|NCT00908037|Secondary|Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2|Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline value included any scheduled and unscheduled post-Baseline assessment.|From Week 1 to Week 7 of Part 2|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety Population|||Breaths per min||Standard Deviation|Mean
1443541|NCT00908037|Secondary|Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3|Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: <85, 85-115, >115; for Cohort 2: <85, 85-120,>120; and Cohort 3: <95, 95-135, >135. RR for DBP (mmHg) for Cohort 1: <45, 45-70,>70; for Cohort 2: <50, 50-75, >75; and Cohort 3: <55, 55-85, >85.|From Baseline through Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1443542|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline and post-Baseline up to Study Week 31 of Part 2/3|Safety Population, only those participants enrolled during Part 2/3 were analyzed.|||Participants|||Number
1443543|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline and post-Baseline up to Study Week 7 of Part 2|Safety Population, only those participants enrolled during Part 2 were analyzed.|||Participants|||Number
1443544|NCT00908037|Secondary|Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1|Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.|From Baseline up to Study Week 24 of Part 1|Safety Population, only those participants enrolled during Part 1 were analyzed.|||Participants|||Number
1443545|NCT00908037|Secondary|Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute [ ml/min]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles [mg/mmol]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1443546|NCT00908037|Secondary|Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Hematology parameters included: erythrocytes (RR: 4.2 - 6.1 teragrams per liter [TI/L]), hemoglobin (RR: 125 - 165 g/L), hematocrit (RR: 0.36 - 0.46), platelets (RR: 170 - 430 gigagrams per liter [GI/L]), mean platelet volume (MPV, RR: 4 - 14 femotoliter [fL]), leukocytes (RR: 3.4 - 11.2 GI/L), total neutrophils (RR: 2.1 - 4.9 GI/L), lymphocytes (RR: 1.4 - 2.9 GI/L), monocytes (RR: 0.2 - 0.9 GI/L), eosinophils (RR: 0.2 - 0.7 GI/L), and basophils (RR: 0.02 - 0.12 GI/L). Baseline values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1443553|NCT00908037|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.|||Participants|||Number
1443547|NCT00908037|Secondary|Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3|Clinical chemistry parameters included: aspartate amino transferase (AST, reference range [RR]: 0-38 International Units per Liter [IU/L]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles [umol]/L), albumin grams [g/L], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles [mmol]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment|Post-Baseline from Week 1 through Follow-up up to Study Week 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
1443548|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline of Part 2/3 through Follow-up|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1443549|NCT00908037|Secondary|Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.|From Baseline through Week 7 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1443550|NCT00908037|Secondary|Kids’ ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1=never, 2=seldom, 3=sometimes, 4=often, 5=always and 9=not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|From Baseline to end of treatment up to Study Week 31|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Score on scale||Standard Deviation|Mean
1443551|NCT00908037|Secondary|Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline and Week 6 of Part 2|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Score on scale||Standard Deviation|Mean
1443552|NCT00908037|Secondary|Kids’ ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1|The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 – Q26 (excluding any answer that is ‘Not applicable’). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.|Baseline, Week 6, Week 12, and Week 24 of Part 1|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Score on scale||Standard Deviation|Mean
1443554|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3|Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.|From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3|ITT Population, only those participants enrolled during Part 2/3 were analyzed.|||Percentage of Participants|||Number
1443555|NCT00908037|Secondary|Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.|The participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 1 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 1 Day 1 to the last dose of study medication + 1 day.|From Baseline up to Week 24+ 1 day of Part 1|ITT Population, only those participants enrolled during Part 1 were analyzed.|||Percentage of Participants|||Number
1443556|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2/3. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|From Baseline up to Study Week 31|ITT Population only those participants enrolled in Part 2/3 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2/3.|||Weeks||Full Range|Median
1443557|NCT00908037|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count|From Baseline through Week 7 of Part 2|ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.|||Weeks||Full Range|Median
1443558|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3|The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
1443559|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3|The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||hour (hr)||Full Range|Median
1443573|NCT00907881|Secondary|Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12|Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases.|Baseline and Week 12|All enrolled participants with available data at both Baseline and Week 12.|||Correlation coefficient|||Number
1443574|NCT00907881|Secondary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)|Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12||||Correlation coefficient|||Number
1443560|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.|The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
1443561|NCT00908037|Secondary|Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3.|The area under the concentration-time curve over the dosing interval (AUC0-t) data was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. From the final model, a single value of AUC(0-t) was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|From Day 1 of treatment up to Study Week 31|Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.|||Microgram*hour per milliliter (ug*h/mL)||95% Confidence Interval|Geometric Mean
1443562|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment during Part 2/3 of the study were reported. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.|Part 2/3 up to Study Week 31|ITT Population. Only evaluable participants were included for this analysis, where participants with a baseline platelet count >10 Gi/L was considered as evaluable.|||Percentage of Participants|||Number
1443563|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.|The percentage of participants achieving platelet counts >=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.|From Day 1 of treatment up to Week 24 of Part 1|ITT Population only those participants enrolled during Part 1 were analyzed.|||Percentage of Participants|||Number
1443564|NCT00908037|Secondary|Weighted Mean Platelet Count|The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.|Baseline and Day 43 of Part 2|ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis|||Gi/L||Standard Deviation|Mean
1443565|NCT00908037|Secondary|Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)|Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count >=50 Gi/L during treatment with eltrombopag in >= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.|Between Day 15 and Day 43 of Part 2|Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.|||Percentage of Participants|||Number
1443566|NCT00908037|Primary|Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)|Participants who achieved a platelet count >=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.|From Day 8 up to Day 43 of Part 2|Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count >10Gi/L was considered as evaluable.|||Percentage of Participants|||Number
1443567|NCT00908011|Secondary|Assessment of Safety Parameters, Specifically Incidence of Complications as Measured by an Increase in AST &/or ALT ≥3-fold ULN & a CK ≥10-fold ULN||3 months from baseline|||||||
1443568|NCT00908011|Secondary|Percent Change in Apolipoprotein B, Percent and Absolute Change Total Cholesterol, LDL, HDL, Triglycerides, Apolipoprotein A1, apolipoproteinB/apoliporoteinA1 Ratio and C-reactive Protein||3 months from baseline|||||||
1443569|NCT00908011|Primary|The Primary Endpoint is the Difference in Final Value of Serum Apolipoprotein B Between Participants Treated With Rosuvastatin Versus Participants Treated With Both Rosuvastatin and Ezetimibe.||3 months from baseline||||mmol/L||Standard Deviation|Mean
1443570|NCT00907907|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
1443571|NCT00907907|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg*hr/mL||Standard Deviation|Mean
1443572|NCT00907907|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||µg/mL||Standard Deviation|Mean
1443575|NCT00907881|Secondary|Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)|Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.|||Score on a scale||Standard Deviation|Mean
1443576|NCT00907881|Primary|Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores|Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.|Week 12|Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.|||Correlation coefficient||95% Confidence Interval|Number
1443577|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½|t½: Observed terminal elimination half-life determined after the last dose on Day 14|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 21 and 20 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ).|||hours||Standard Deviation|Mean
1443578|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 5 and 6 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).|||ng*hr/mL||Standard Deviation|Mean
1443579|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau|AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 23 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to early withdrawals or because PK data fell below the limit of quantitation (BLQ) before the 24-hour dosing interval was complete.|||ng*hr/mL||Standard Deviation|Mean
1443580|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 and 5 subjects in the ST-246 400 mg and 600 mg groups respectively, were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).|||hours||Standard Deviation|Mean
1443581|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax|Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.|||hours||Standard Deviation|Mean
1443582|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 14 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 4 subjects in each of the ST-246 400 mg and 600 mg groups were excluded from PK analysis due to withdrawals or because PK data fell below the limit of quantitation (BLQ).|||ng/mL||Standard Deviation|Mean
1443583|NCT00907803|Secondary|Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax|Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data|Day 1 post-dose|As per protocol. All 16 subjects in the placebo group were excluded from the PK population. In addition, 2 subjects in each of the ST-246 400 mg and 600 mg groups were excluded due to early withdrawals.|||ng/mL||Standard Deviation|Mean
1443584|NCT00907803|Primary|Number of Study Participants Who Tolerated a Single Daily Oral ST-246 Dose as Determined by Safety Parameter Changes According to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table.|Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.|Days 1 to 14; then 24, 48, 72, 96 and 120 hours and 4 weeks after final dose|As per protocol. During the study, a total of 6 withdrawals occurred. These were due to adverse events (2) and consent withdrawal (1) in the 400 mg group, and subject request (1), lost to follow-up (1) and protocol violation (1) in the 600 mg group.|||Participants|||Number
1443585|NCT00907777|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.|Throughout the entire study period (approximately 1 month per subject)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Subjects|||Number
1443586|NCT00907777|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.|Within 31 days (Day 0-30) post-additional vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Subjects|||Number
1443814|NCT00905554|Primary|Number of Patients Undergoing Complete Unsedated Colonoscopy||6-9 months||||participants|||Number
1443587|NCT00907777|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Subjects|||Number
1443588|NCT00907777|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|"Solicited general symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 8-day (Days 0-7) post-additional dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.|||Subjects|||Number
1443589|NCT00907777|Secondary|Anti-protein D Antibody Concentrations|The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1443590|NCT00907777|Secondary|Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1443591|NCT00907777|Secondary|Cross-reactive Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1443592|NCT00907777|Secondary|Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1443593|NCT00907777|Primary|Vaccine Pneumococcal Serotype Antibody Concentrations|The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.|Before (PRE) and one month after (POST) the additional dose|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.|||microgram/milliliter||95% Confidence Interval|Geometric Mean
1443594|NCT00907738|Primary|Percent of Participants With a Serious Drug-related Adverse Event (AE)|"A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.~A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug."|From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)||||percent of participants|||Number
1443595|NCT00907621|Secondary|Parents Evaluation of Benefit to the Child.|"Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well.~The numbers are the actual evaluations on the time specified."|5 days, 1 , and 4 weeks after the first treatment|The differences in numbers on parents evaluation of the childs condition (37 and 38) is due to one location assistant not reporting back on these results. Thus the number of interviews, 84, and secondary outcome data is not consistent with the numbers in the flow diagram.|||units on a scale||Standard Deviation|Mean
1443596|NCT00907621|Primary|Change in Crying Time Per 24 Hour Period.|Crying time per 24 hour period at baseline and post treatment|6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.||||minutes crying time pr 24 hour||95% Confidence Interval|Mean
1443597|NCT00907517|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who discontinued study treatment due to an AE is summarized.|Up to 135 days|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1443619|NCT00907335|Secondary|Measurement of Success 2|Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12||||Participants|||Number
1443598|NCT00907517|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who experienced an AE is summarized.|Up to 45 days after last dose of study treatment (Up to 180 days)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1443599|NCT00907517|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number of participants who experienced a DLT during Cycle 1 is summarized.|Throughout Cycle 1 (Up to 6 weeks)|The population consisted of all participants who received at least one dose of study treatment.|||Participants|||Number
1443600|NCT00907478|Secondary|Number of Participants Who Developed Antibodies or Neutralizing Antibodies to Romiplostim or to Endogenous Thrombopoietin|"Two validated assays were used to test for antibodies to romiplostim, the thrombopoietin-mimetic peptide component of romiplostim (TMP) and to endogenous thrombopoietin (TPO). The first was an immunoassay to confirm the presence of antibodies. The second was a cell-based bioassay to detect neutralizing or inhibitory effects in vitro. If a sample was positive in both assays, a participant was defined as positive for neutralizing antibodies.~Persistent antibodies were those positive at the last timepoint tested and transient are defined as positive post-dose but negative at the last time point tested."|Every 24 weeks and at the end of study visit (4 weeks or 12 weeks after study drug discontinuation).|All participants who received at least one dose of romiplostim.|||participants|||Number
1443601|NCT00907478|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant that did not necessarily have a causal relationship with this treatment, or any such occurrence or worsening of a pre-existing medical condition from the first dose of investigational product through the last study visit. A serious adverse event is defined as an AE that is fatal or life threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. The relationship of each AE to the study drug was assessed by the investigator. The severity of each AE was graded using using CTCAE 3.0; For any AEs not listed in CTCAE, the Amgen Standard Severity Scoring System was used: 1: Mild- Aware of sign or symptom, but easily tolerated; 2 Moderate- Discomfort enough to cause interference with usual activity; 3: Severe- Incapacitating with inability to work or do usual activity; 4: Life-threatening; 5: Fatal.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim|||participants|||Number
1443602|NCT00907478|Secondary|Percentage of Participants With CTCAE Grade ≥ 2 Shift in Anemia or Neutropenia|Anemia was identified by laboratory values with hemoglobin < the lower limit of normal (LLN) or the Medical Dictionary for Regulatory Activities (MedDRA) terms prespecified by the sponsor. Neutropenia was identified by laboratory values with absolute neutrophil count <1.8x10^9/L or the MedDRA terms pre-specified by the sponsor. Severity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, based on the following: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.|From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks.|All participants who received at least one dose of romiplostim|||percentage of participants||95% Confidence Interval|Number
1443603|NCT00907478|Secondary|Number of Participants With Improvement of Reticulin to a Grade of ≤ 2 for Participants Who Developed Grade 3 Reticulin|The number of participants who had any improvement of reticulin to a grade of ≤ 2 for participants who developed grade 3 reticulin after initial exposure to romiplostim as measured by the modified Bauermeister grading scale. The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|12 weeks after romiplostim discontinuation|Participants with Grade 3 reticulin at Year 1, 2 or 3 and who had a follow-up bone marrow biopsy 12 weeks after romiplostim discontinuation. Two participants with grade 3 reticulin did not have a bone marrow biopsy performed 12 weeks after romiploastim discontinuation.|||participants|||Number
1443604|NCT00907478|Secondary|Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals|A clinically relevant change in QTc (Fridericia) interval is defined as an absolute QTc interval >500 ms or a QTc Interval increase from Baseline >60 ms post romiplostim exposure. 12-lead electrocardiograms (ECG) were performed in triplicate at Baseline, Week 3 and Week 12; the average of of the 3 values at each assessment was used.|Baseline, Week 3 and Week 12|All participants who received at least one dose of romiplostim.|||percentage of participants||95% Confidence Interval|Number
1443620|NCT00907335|Secondary|Measurement of Success 1|Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear.|Week 12||||Participants|||Number
1443605|NCT00907478|Secondary|Percentage of Participants Who Developed an Increased Modified Bauermeister Grade|Increased modified Bauermeister grade refers to an increase by ≥ 2 severity grades or an increase to grade 4 (ie, grade 0 to 2-4, grade 1 to 3-4, grade 2 to 4, or grade 3 to 4 over baseline). The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining).|At Year 1, Year 2, or Year 3 post romiplostim exposure|Participants who had evaluable reticulin silver stain results|||percentage of participants||95% Confidence Interval|Number
1443606|NCT00907478|Secondary|Number of Participants With Collagen Fibrosis 12 Weeks After Romiplostim Discontinuation in Participants Who Developed Collagen Fibrosis at Years 1, 2, or 3|The number of participants with collagen fibrosis as evidenced by trichrome staining 12 weeks after romiplostim discontinuation in participants who developed collagen fibrosis at Years 1, 2, or 3 after initial exposure of romiplostim, assessed by the central laboratory using the modified Bauermeister grading scale.|12 weeks after romiplostim discontinuation|Participants with collagen fibrosis at Year 1, 2 or 3 and with available trichome staining results 12 weeks after study drug discontinuation. One participant with collagen fibrosis refused the follow-up bone marrow biopsy.|||participants|||Number
1443607|NCT00907478|Primary|Percentage of Participants With Collagen Fibrosis|The percentage of participants who developed collagen fibrosis as evidenced by trichrome staining. Bone marrow biopsy samples were assessed using the modified Bauermeister grading scale by a central laboratory.|At Years 1, 2 or 3 after initial exposure of romiplostim|Participants who had evaluable trichrome stain results|||percentage of participants||95% Confidence Interval|Number
1443608|NCT00907426|Other Pre-specified|Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4|Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.|Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Percentage of Participants|||Number
1443609|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Darkness at Month 4|Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Eyelash Intensity Units||Standard Deviation|Mean
1443610|NCT00907426|Secondary|Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4|Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Millimeters squared (mm^2)||Standard Deviation|Mean
1443611|NCT00907426|Secondary|Change From Baseline in Upper Eyelash Length at Month 4|Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.|Baseline, Month 4|Intent-to-Treat: All randomized subjects who had baseline and Month 4 data collected for this outcome measure|||Millimeters (mm)||Standard Deviation|Mean
1443612|NCT00907426|Primary|Percentage of Treatment Responders at Month 4|Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.|Month 4|Intent-to-Treat: All randomized subjects|||Percentage of Subjects|||Number
1443613|NCT00907374|Secondary|Endothelial Dysfunction|Post hyperemia increase in blood flow - fold increase from before and after occluding BP; values are mean of all participants in 6-36 months of study period.|6 to 36 months|complerters|||Fold increase||Standard Deviation|Mean
1443614|NCT00907374|Secondary|Carotid Artery Intima Thickness|Thickness of intima of right carotid artery; average of all particpants from 6-36 months of study|6 to 36 months|Completers|||mm||Standard Deviation|Mean
1443615|NCT00907374|Secondary|Estimated Glomerular Filtration Rate|This is an average for all participants during the 3-36 month study period|3 to 36 months|Completers|||ml/min/1.73 meters squared||Standard Deviation|Mean
1443616|NCT00907374|Primary|Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio|Average of ratio for all participants during the 3-36 months of the study|3 to 36 months||||Ratio||Standard Deviation|Mean
1443617|NCT00907335|Secondary|Global Assessment|Participants showing improvement from baseline in the Investigator’s Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject’s improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse.|Baseline to Week 12||||Participants|||Number
1443618|NCT00907335|Secondary|Measurement of Success 3|Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject’s improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of “Excellent” or “Good” scores.|Week 12||||Participants|||Number
1443622|NCT00907335|Primary|Change From Baseline in Total Non-inflammatory Lesion Count|Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.|Baseline to Week 12||||Lesions||Standard Error|Least Squares Mean
1443623|NCT00907257|Secondary|Measurement of Success|"Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows:~0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe."|Baseline to Week 12|Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF)|||Participants|||Number
1443624|NCT00907257|Secondary|Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals|Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions).|Baseline to Week 12|Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF).|||Lesions||Standard Error|Least Squares Mean
1443625|NCT00907257|Primary|Change From Baseline in Total Facial Acne Lesion Count|Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement.|Baseline to Week 12|Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations.|||Lesions||Standard Error|Least Squares Mean
1443626|NCT00907218|Secondary|Spontaneous Reports of Adverse Effects|Reports of adverse events were completed at baseline and weekly visits throughout the trial.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
1443627|NCT00907218|Secondary|Vital Signs|Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
1443628|NCT00907218|Secondary|ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)|The Clinical Global Impression Scale of ADHD for Improvement and Severity assess overall severity and change in severity of ADHD. The CGI-I scale is rated from 1 to 7 (1=very much improved; 7=very much worse). The CGI-S is rated from 1 to 7 as well (1=not ill; 7=extremely ill).|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
1443629|NCT00907218|Secondary|Rates of Smoking Cessation|Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
1443630|NCT00907218|Secondary|Exhaled CO Levels|At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.|Weekly over 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
1443631|NCT00907218|Primary|Time Line Follow Back of Cigarette Smoking|The reduction in cigarette smoking, defined as the change from baseline on the amount of cigarettes per day smoked (cpd), using the time-line follow back method. This method involves asking subjects to retrospectively estimate their cigarette use 7 days to 2 years prior to the interview date.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
1443632|NCT00907218|Primary|The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)|The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54.|Weekly for 7 weeks|Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed||||||
1443633|NCT00907153|Other Pre-specified|Change From Baseline in Mean Intact Parathyroid Hormone (i-PTH)|Intact parathyroid hormone levels were assessed as they have been linked with obesity and insulin resistance.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||pg/mL||95% Confidence Interval|Mean
1443634|NCT00907153|Other Pre-specified|Change From Baseline in Mean Vitamin D Binding Protein|Vitamin D binding protein levels were assessed as it has been linked with insulin resistance and type 2 diabetes.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
1443635|NCT00907153|Other Pre-specified|Change From Baseline in Mean 25-hydroxyvitamin D|Total 25-hydroxyvitamin D was assayed by the Immunodiagnostic Systems radioimmunoassay.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||ng/mL||95% Confidence Interval|Mean
1443636|NCT00907153|Secondary|Change From Baseline in Mean Free Testosterone|Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||ng/dL||95% Confidence Interval|Mean
1443637|NCT00907153|Secondary|Change From Baseline in Mean Total Testosterone|Total and free testosterone levels were assessed from blood samples to evaluate effects on hyperandrogenemia in PCOS.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||ng/dL||95% Confidence Interval|Mean
1443638|NCT00907153|Secondary|Change From Baseline in Mean Triglycerides|Lipid profile was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
1443642|NCT00907153|Secondary|Change From Baseline in Mean Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is a validated measure of insulin resistance based on fasting insulin and glucose. HOMA-IR is calculated as the product of fasting glucose and insulin divided by 22.5.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||units on a scale||95% Confidence Interval|Mean
1443643|NCT00907153|Secondary|Change From Baseline in Mean Insulin Sensitivity Index (ISI 0,120)|Participants underwent a 75-g oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 120 minutes and used to calculate the insulin sensitivity index (ISI0,120). The ISI 0,120 = the glucose uptake rate divided by the mean plasma glucose divided by the log(mean serum insulin).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg·l^2/mmol·mU·min||95% Confidence Interval|Mean
1443644|NCT00907153|Secondary|Change From Baseline in Mean 2-hour Insulin|Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||uU/mL||95% Confidence Interval|Mean
1443645|NCT00907153|Secondary|Change From Baseline in Mean 2-hour Glucose|Participants underwent a 75-gram oral glucose tolerance test, in which blood samples for glucose and insulin were obtained at 0 and 2 hours and used to calculate the insulin sensitivity index (ISI 0,120).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
1443646|NCT00907153|Secondary|Change From Baseline in Mean Fasting Insulin|Insulin was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||uU/mL||95% Confidence Interval|Mean
1443647|NCT00907153|Secondary|Change From Baseline in Mean Fasting Glucose|Glucose was assessed after 12 hours of fasting.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/dL||95% Confidence Interval|Mean
1443648|NCT00907153|Secondary|Change From Baseline in Mean Diastolic Blood Pressure|Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mm Hg||95% Confidence Interval|Mean
1443649|NCT00907153|Secondary|Change From Baseline in Mean Systolic Blood Pressure|Blood pressure was measured in the right arm in the sitting position after a 15-minute rest.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mm Hg||95% Confidence Interval|Mean
1443650|NCT00907153|Secondary|Change From Baseline in Mean High Sensitive C-reactive Protein (hsCRP)|High sensitive C-reactive protein (hsCRP) was assessed as a measure of inflammation.|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||mg/L||95% Confidence Interval|Mean
1443651|NCT00907153|Primary|Change From Baseline in Mean Quantitative Insulin Sensitivity Check Index (QUICKI)|Quantitative insulin sensitivity check index (QUICKI) is a validated measure of insulin sensitivity based on fasting insulin and glucose. Quantitative insulin sensitivity check index (QUICKI) = 1/[log(I(0)) + log(G(0))]).|Baseline and 12 weeks|All analyses were by intention to treat. All randomized participants received and ingested the treatment that they were randomly assigned to.|||units on a scale||95% Confidence Interval|Mean
1443652|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Stinging/Burning|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
1443653|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Scaling|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
1443654|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Dryness|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
1443655|NCT00907101|Secondary|Worst Post Baseline Tolerability Assessment - Erythema|Please note: Tolerability assessments were recorded separately from adverse events. Tolerability changes which may have required a temporary or permanent interruption of the subject’s participation in the study (at his/her request or at the investigator’s discretion), or concomitant treatment, was to be recorded in the AE form of the CRF. An entry was to be made on the AE form for all AEs.|Week 4||||participants|||Number
1443656|NCT00907101|Primary|Change From Baseline in Quantitative Bacteriology Measurements at Week 4|Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².|Week 4||||log10 CFU/cm2||Standard Deviation|Mean
1443657|NCT00907088|Secondary|IDA (Hemoglobin < 110 g/L With Iron Deficiency)||Age 24 months|||||||
1443658|NCT00907088|Secondary|Iron Deficiency (Defined as Serum Ferritin <10 mcg/L and MCV < 70 mcm3 Iron Deficiency.||Age 24 months|||||||
1443660|NCT00906971|Primary|Retentive Fecal Incontinence.|"Retentive fecal incontinence is the lose of fecal while the patient tries to avoid the bowel movement.~The patients (or their parents) received a bowel diary and they fulfilled about frequency of episodes of retentive fecal incontinence weekly."|six weeks||||days/week||Standard Deviation|Mean
1443661|NCT00906971|Primary|Frequency of Defecation.|The patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.|six weeks||||days/week||Standard Deviation|Mean
1443662|NCT00906945|Post-Hoc|Relapse Free-survival Rate||2 years|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi were evaluable for this outcome measure.|||percentage of participants|||Number
1443663|NCT00906945|Secondary|Overall Survival|Overall survival: Defined as the date of first dose of study drug to the date of death from any cause.|Median follow-up was 34.6 months||||days||Full Range|Median
1443664|NCT00906945|Secondary|Time to Treatment Failure||8 days|Data was not collected for this outcome measure. It is not well defined in the literature as when to measure treatment failure. Relapse free survival is a better way to measure response duration (this outcome measure was added to the results).||||||
1443665|NCT00906945|Secondary|Time to Progression|Recurrence / morphologic relapse: Defined as reappearance of blasts in the blood or the finding of > 5% blasts in the BM, not attributable to any other cause. New dysplastic changes are considered a relapse. If there are no blasts in the peripheral blood and 5-19% blasts in the BM, the BM biopsy and aspirate should be repeated in > 1 week to confirm relapse.|2 years|Data was not collected for this outcome measure. Progression is very hard to define acute myeloid leukemia and including it as a pre-specified secondary outcome measure in the protocol was an oversight.||||||
1443666|NCT00906945|Secondary|Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity||6 hours after plerixafor|29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in CXCR4 clone 1D9||Standard Deviation|Mean
1443667|NCT00906945|Secondary|Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity||6 hours after plerixafor|29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in CXCR4 clone 1D9||Standard Deviation|Mean
1443668|NCT00906945|Secondary|Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count||6 hours after plerixafor|31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in AML blast count||Standard Deviation|Mean
1443669|NCT00906945|Secondary|Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells||6 hours after plerixafor|31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure.|||fold change in white blood cells||Standard Deviation|Mean
1443670|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Platelet Recovery|-Platelet recovery is defined as platelets >= 100,000/mm3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR whose platelets were >=100,000/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
1443671|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Platelet Recovery|-Platelet recovery is defined as platelets >= 50,000/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had CR whose platelets were >=50,000/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
1443672|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery|-Neutrophil recovery is defined as absolute neutrophil count >= 1000/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=1000/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
1443673|NCT00906945|Secondary|Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery|-Neutrophil recovery is defined as absolute neutrophil count (ANC) >= 500/mm^3|Up to 62 days after treatment|All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=500/mm^3 were evaluable for this outcome measure.|||days||Full Range|Median
1443674|NCT00906945|Secondary|Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency||30 days following end of treatment||||number of events|||Number
1443675|NCT00906945|Primary|Phase II: Complete Response Rate (CR+CRi)|"Morphologic complete remission (CR): Defined as morphologic leukemia-free state, including <5% blasts in BM aspirate with marrow spicules and a count of > 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC > 1,000/mm3, platelet count > 100,000/mm3.~Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia <1,000/mm3 or thrombocytopenia <100,000/mm3."|45 days|Only patients enrolled in Phase 2 portion were analyzed for this outcome measure.|||percentage of participants|||Number
1443676|NCT00906945|Primary|Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC||Completion of Phase I enrollment (17 months)|Number of participants analyzed is the number of participants enrolled in the Phase I portion of the study.|||mcg/kg/day|||Number
1443677|NCT00906789|Secondary|Sensitivity and Specificity Using SoftView Software|Sensitivity and specificity were calculated using the radiologists' responses of recommendations for follow-up with CT or biopsy. Truth was whether or not the nodule identified was found to be cancer. Sensitivity is the percentage of correct identification of a positive case (a case with cancer). Specificity is the percentage of negative cases (those without cancer) that were correctly identified as not having cancer. The mean values of 15 radiologists are used.|Three days of experiment over 3-5 months, varied by participant||||percentage of cases||95% Confidence Interval|Mean
1443678|NCT00906789|Other Pre-specified|Difference in the Area Under the LROC Curve Comparing OnGuard 1.0 and OnGuard 5.1|This reports the comparison of the detection of lung nodules that were proven to represent lung cancers. It compares the results of two versions of computer-aided detection software: OnGuard 1.0 from 2001 and OnGuard 5.1 from 2009. The results represent the responses of radiologists when they use one or the other types of software. To compare radiologists' results with the two types of software, the measurement analyzed was the difference in the areas under the localized receiver operating characteristic curve (LROC). The results from the 15 participating radiologists were averaged (mean value). The area under the LROC curve is a measure of the trade-offs between sensitivity and 1-specificity that occurs as the level of certainty of a positive finding changes. It is normally reported as a decimal without units. In this study dsign, a lower number indicates that the new method (OnGuard 5.1), if statistically significant, if better.|5 months|81 of the 263 radiographs contained a non-calcified nodule that had been diagnosed as lung cancer. Power calculation showed 246 patients, in a 2:1 ratio of nodule absent to present would provide 80% power to detect a difference in areas under the curve of 0.10 or greater.|||unitless|Participants|95% Confidence Interval|Mean
1443679|NCT00906789|Primary|Improvement in Cancer Detection as Measured by Localized Receiver Operating Characteristic) LROC Changes Under the LROC Curve.|"Standard methods for LROC methodology and statistical analysis were used. We are testing two different types of software using different cases, but the same radiologists to control for radiologist differences. LROC is Localized Receiver Operating Characteristic. LROC measures the trade-offs between sensitivity and specificity as radiologists use different levels of suspicion of disease. This analysis is for the software that decreases the visibility of the ribs and clavicles while preserving (and potentially enhancing) the visibility of the lungs and lung diseases. In this case, the level of suspicion recorded was for the radiologist's concern that a finding did or did not represent cancer. Please note that the FDA approved indications for use is to detected nodules that may represent cancer, but in our study scoring for a true finding was based on whether or not the nodule did represent cancer.~A larger number, if statistically significant, indicates that that method is better."|Three days of experiment over 3-5 months, varied by participant|122 subjects had cancer that potentially could be detected on their chest radiograph. Power analysis showed that sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater.|||unitless|Participants|95% Confidence Interval|Mean
1443680|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 12 months||||mm||Standard Deviation|Mean
1443681|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 6 months||||mm||Standard Deviation|Mean
1443682|NCT00906776|Secondary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 6 months||||mm||Standard Deviation|Mean
1443683|NCT00906776|Secondary|Change in Probing Pocket Depth (PPD)|PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket.|Baseline and 12 months||||millimeters||Standard Deviation|Mean
1443684|NCT00906776|Secondary|Change in Distance Between the Cementum-enamel-junction and the Base of the Vertical Bone Defect||Baseline and 6 months||||mm||Standard Deviation|Mean
1443685|NCT00906776|Primary|Change in Clinical Attachment Level (CAL)|CAL is calculated as the sum of Probing Pocket Depth (PPD) and Recession (REC). PPD is measured using a periodontal probe from the gingival margin to the bottom of the pocket. REC is measured using a periodontal probe from the gingival margin to the cemento-enamel junction (CEJ).|Baseline and 12 months||||millimeters||Standard Deviation|Mean
1443686|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
1443687|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
1443688|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443689|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443690|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443691|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h,, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443692|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
1443693|NCT00906698|Secondary|Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||hours||Full Range|Median
1443694|NCT00906698|Secondary|Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443695|NCT00906698|Secondary|Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443696|NCT00906698|Secondary|Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the TS, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443697|NCT00906698|Secondary|Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State||0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing|All patients treated in the MTD cohort, for which evaluable PK parameters were available for the analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443698|NCT00906698|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose of study medication to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0. Median time results from unstratified Kaplan-Meier estimates.|From first dose of study medication to the occurrence of progression or death whichever came first, up to 44 months.|All patients treated in the MTD cohorts.|||weeks||Inter-Quartile Range|Median
1443699|NCT00906698|Secondary|Best Percentage Change in Tumour Size|Best percentage change in tumour size was the best percentage change in the sum of diameters of target lesions and was calculated as (minimum sum of diameters post baseline - sum of diameters at baseline)/sum of diameters at baseline. Negative values indicate a decrease, positive values an increase.|Screening and every 8 weeks after starting of treatment, up to 44 weeks.|Patients from Treated Set (TS).|||percentage change in tumour size||Standard Error|Mean
1443700|NCT00906698|Secondary|Duration of Disease Control|Duration of disease control was measured from the start of study treatment to the time of progression or death, whichever occured first.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with disease control.|||days||Full Range|Median
1443701|NCT00906698|Secondary|Duration of Objective Response|The duration of objective response was measured from the time of first documented confirmed CR or PR to the time of progressive disease or death, whichever occured earlier.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from Treated Set (TS) with Objective Response.|||days||Full Range|Median
1443702|NCT00906698|Secondary|Time to Objective Response|The time to OR was the duration from the first treatment to the time when the measurement criteria for first documented confirmed CR and/or PR were met according to RECIST 1.0 criteria.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Patients from the Treated Set (TS) with objective response.|||days||Full Range|Median
1443703|NCT00906698|Secondary|Number of Patients With Disease Control (DC)|DC is defined as confirmed complete response (CR), partial response (PR) and stable disease (SD) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).|||participants|||Number
1443704|NCT00906698|Secondary|Number of Patients With Objective Response (OR)|OR is defined as confirmed complete response and confirmed partial response (PR) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0).|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).|||participants|||Number
1443728|NCT00906373|Secondary|PK: Clearance (CL) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443705|NCT00906698|Secondary|Number of Patients With Best Overall Response|Overall response is defined as complete response, partial response and stable disease and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). Complete response (CR) and partial response (PR) had to be confirmed by a subsequent tumour assessment at least 28 days after the criteria for CR or PR were first met. To confirm a status of stable disease, the duration of stable disease was to be at least 42 days.|From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from the Treated Set (TS).|||participants|||Number
1443706|NCT00906698|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). 3+3 dose escalation design. MTD based on DLTs during first treatment course. After MTD was determined, additional patients were included at the MTD in an expansion cohort.|28 days|Treated Set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||participants|||Number
1443707|NCT00906503|Primary|Feasibility of Ultra Short-term Steroid Therapy to Increase the Accuracy of FDG-PET/CT Imaging|The blood glucose of all patients will be checked by accu-check before the injection of 18F-FDG. The acceptable blood glucose level will be ≤120 mg/dl. Any participant experienced elevated fasting blood glucose of more than 120 mg/dl after steroid therapy, he /she will be asked to come back to the PET center within 48 hours to check the blood glucose level. If the blood glucose level did not decline to baseline level, the participant will be asked to follow with his/her family doctor for management. Participants with history of systemic hypertension will be monitored for increased blood pressure. After 50-to-70 minutes period for FDG incorporation into presumed lesions, patient will under go a limited 18F-FDG PET/CT for the area of the interest (1-2 bed positions). PET imaging will be performed using a GE Discovery STE PET/CT system (GE Medical Systems, Milwaukee, WI).|24-48 hours||||gm/ml||Standard Deviation|Mean
1443708|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|12 months||||% of implants|||Number
1443709|NCT00906425|Secondary|Implant Survival Rate|The percentage of implants that remain in place in the jaw.|6 months||||% of implants|||Number
1443710|NCT00906425|Primary|Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)|The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.|Baseline and 6 months|ITT population|||millimeters||Standard Deviation|Mean
1443711|NCT00906399|Secondary|Estimated Proportion of Participants With Sustained Disability Progression at 1 Year|Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method.|1 Year|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression.|||proportion of participants|||Number
1443712|NCT00906399|Secondary|Proportion of Participants Relapsed at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method.|Year 1|ITT population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo). Participants who did not experience a relapse prior to switching to alternative MS medications or withdrew from study were censored at the time of switch/withdrawal.|||proportion of participants|||Number
1443713|NCT00906399|Secondary|Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year|Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions.|1 Year|ITT population, with at least 1 post-baseline assessment. Missing data prior to alternative MS medications and visits after participants switched to alternative MS medications imputed based on previous visit data assuming the constant rate of lesion development or group mean at same visit.|||lesions||95% Confidence Interval|Mean
1443714|NCT00906399|Primary|Annualized Relapse Rate (ARR) at 1 Year|A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3).|1 Year|Intent-to-treat (ITT) population: participants who were randomized and received at least 1 dose of study treatment (peginterferon beta-1a or placebo).|||relapses per person-years||95% Confidence Interval|Number
1443715|NCT00906373|Secondary|The Number of Participants With Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)|A participant's serum sample was considered positive for antibodies against cixutumumab if it exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-cixutumumab level seen in healthy untreated individuals. A participant was considered to have an anti-cixutumumab response if there were 2 consecutive positive samples or if the final sample tested was positive.|Predose, immediately prior to the first Cycle 3 and Cycle 5 infusions (3-week cycle) and 30 days after last dose of study drug|Zero participants were analyzed. No assay was available to assess serum anti-cixutumumab antibodies.||||||
1443748|NCT00906204|Secondary|Kidney Function|Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study)|12 months post-transplantation||||mL/min/1.73m^2||Standard Deviation|Mean
1443716|NCT00906373|Secondary|Duration of Response (DOR)|Duration of CR or PR was defined as time from first objective assessment of CR or PR until first date of PD or death from any cause. Response was defined using RECIST v 1.0 criteria. CR was defined as disappearance of all target and nontarget lesions and normalization of tumor marker levels. PR was defined as a ≥30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. PD defined as a ≥20% increase in the sum of LD of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants with no PD, who discontinued treatment for toxicity or a reason other than PD, or were lost to follow-up, were censored at date of last tumor assessment. Participants who began new anticancer therapy prior to PD or death were censored at date of last tumor assessment prior to new therapy. Participants who died or had PD after ≥2 missed tumor assessments were censored at date of last tumor assessment prior to the missed assessments|Date of first occurrence of CR or PR to first date of PD or death up to 8 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 1.|||months||95% Confidence Interval|Median
1443717|NCT00906373|Secondary|Time to Disease Progression (TTP)|TTP is defined as the time from the date of first dose of study drug until the date of objective disease progression. Participants without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and lost to follow-up were censored at the date of the last objective tumor assessment before loss to follow-up. Participants who began new anticancer therapy prior to PD or death were censored at date of last tumor assessment prior to new therapy. Participants who died or had PD after ≥2 missed tumor assessments were censored at date of last tumor assessment prior to the missed assessments.|Date of first dose of study drug to date of PD up to 12 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 14.|||months||95% Confidence Interval|Median
1443718|NCT00906373|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose of study drug to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.|Date of first dose of study drug to date of death up to 22 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 19.|||months||95% Confidence Interval|Median
1443719|NCT00906373|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) [Objective Response Rate (ORR)]|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR was defined as the disappearance of all target and nontarget lesions and the normalization of tumor marker levels. PR was defined as having a ≥30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator when calculating the response rate. Percentage of participants was calculated as: CR + PR / total number of participants in the treatment group * 100.|Date of first dose of study drug to PD up to 12 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2.|||percentage of participants||95% Confidence Interval|Number
1443720|NCT00906373|Secondary|PK: Vss Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443721|NCT00906373|Secondary|PK: AUC Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443722|NCT00906373|Secondary|PK: CL Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443723|NCT00906373|Secondary|PK: t1/2 Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443724|NCT00906373|Secondary|PK: Cmin Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443725|NCT00906373|Secondary|PK: Cmax Cycle 3||Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443726|NCT00906373|Secondary|PK: Volume of Distribution at Steady State (Vss) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443727|NCT00906373|Secondary|PK: Area Under the Concentration Versus Time Curve (AUC) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443749|NCT00906204|Secondary|Incomplete Thymoglobulin Infusion||First 7 days post-transplantation||||participants|||Number
1443729|NCT00906373|Secondary|PK: Half-Life (t1/2) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443730|NCT00906373|Secondary|PK: Minimum Concentration (Cmin) Cycle 1||Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443731|NCT00906373|Secondary|Pharmacokinetic (PK): Maximum Concentration (Cmax) Cycle 1||Cycle 1, Day 1: Predose, 1 hour (h), 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)|Zero participants analyzed. No PK analysis was done, the assay used for PK assessment was not reliable and the values obtained could not be used. The samples expired before a new assay was developed, so data were not collected.||||||
1443732|NCT00906373|Secondary|Number of Participants With Adverse Events (AEs)|Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|First day of treatment up to 22 months|All randomized participants who received any amount of study drug.|||Participants|||Count of Participants
1443733|NCT00906373|Primary|Progression Free Survival (PFS)|PFS is defined as the time from date of first dose of study drug until the date of objective PD or death due to any cause, whichever occurs first. PD defined as a ≥20% increase in the sum of the longest diameter (LD) of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants who died without PD were considered to have progressed on the date of death. Participants who were alive and without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and are subsequently lost to follow-up were censored at the date of their last objective tumor assessment before loss to follow-up. Participants who progressed or died after ≥2 missed tumor assessment visits were censored at the date of their last objective tumor assessment before missed assessments. Participants who begin a new anticancer therapy were censored at the date of their last objective tumor assessment before initiation of new therapy.|Date of first dose of study drug up PD or death up to 12 months|All randomized participants in Cohort 2 who received any amount of study drug, per the protocol efficacy analysis was only performed for Cohort 2. Participants censored = 10.|||months||95% Confidence Interval|Median
1443734|NCT00906347|Secondary|Time Elapsed From Start of Labor Augmentation to Delivery||Initiation of augmentation until delivery|Intent to treat|||minutes||Inter-Quartile Range|Median
1443735|NCT00906347|Secondary|Method of Delivery||At delivery|Intent to treat|||participants|||Number
1443736|NCT00906347|Secondary|Maternal Hypovolemia Requiring Blood Transfusion||Until hospital discharge|Intent to treat|||participants|||Number
1443737|NCT00906347|Secondary|Maternal Chorioamnionitis|Temperature 38 degrees C or higher in the absence of other sources of infection|During labor|Intent to treat|||participants|||Number
1443738|NCT00906347|Secondary|Admission of Neonatal Intensive Care Unit||Until hospital discharge|Intent to treat|||infants|||Number
1443739|NCT00906347|Secondary|Umbilical Cord Artery pH <7.1||Obtained at delivery|Intent to treat|||infants|||Number
1443740|NCT00906347|Secondary|Infant Apgar Score <4|Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.|5 minutes after delivery|Intent to treat|||infants|||Number
1443741|NCT00906347|Primary|Uterine Tachysystole|Defined as six contractions in two consecutive 10-minute periods|Up to four hours after administration of study drug|Intent to treat|||participants|||Number
1443742|NCT00906282|Secondary|Complete Resection Rate|The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).|At weeks 15-18||||percentage of patients|||Number
1443743|NCT00906282|Secondary|Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)|pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).|At 15-18 weeks|The amount of residual tumor measured in centimeters (cm).|||centimeters||Full Range|Median
1443744|NCT00906282|Secondary|Pathologic Response Rate|Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.|weeks 15 -18||||percentage of participants|||Number
1443745|NCT00906282|Secondary|Objective Tumor Response|Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]|At 6 and 12 weeks||||percentage of participants|||Number
1443746|NCT00906282|Primary|3-Year Overall Survival Rate|The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.|36 months||||percentage of participants||95% Confidence Interval|Number
1443747|NCT00906243|Primary|Phase I: Assessment of Safety and Tolerability of the Trial Regimen|"Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0:~All Categories equal or greater than grade 3~Allergy/autoimmunity equal or greater than grade 2~Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0."|At Nine Weeks with Follow Up at One Year|Phase 1 consisted of cohort 1 with 3 subjects and cohort 2 with three subjects.|||events|||Number
1443753|NCT00906204|Primary|Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function|"The composite endpoint components and definitions are:~Fever: Body temperature ≥ 38.5˚C.~Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors.~Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for > 12 hours out of a 24 hour period.~Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia)~Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation"|During first 7 days after kidney transplantation||||participants|||Number
1443754|NCT00906178|Secondary|Unprotected Sex at Three-month Follow-up|Ever had vaginal or anal sex without a condom in the past 90 days|3 months post-intervention|ITT--Intention to Treat|||participants|||Number
1443755|NCT00906178|Secondary|Abstinence at Three-month Follow-up|Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days|3 months post-intervention|ITT--Intention to Treat|||participants|||Number
1443756|NCT00906178|Primary|Sexual Abstinence|Not having had vaginal or anal sex in the past three months|6-months post-intervention|ITT - Intention to Treat|||participants|||Number
1443757|NCT00906178|Primary|Sex Without a Condom as Assessed by Self-report|Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months|6-months post-intervention|ITT - Intention to Treat|||participants|||Number
1443758|NCT00906087|Secondary|Myocilin Mutation Arg272Gly in Subjects|Number of subjects with Myocilin Arg272Gly|10 week study|Only 1 participant had a MYOC mutation in the 3 exons|||Participants|||Count of Participants
1443759|NCT00906087|Primary|Blood Pressure in Sitting to Supine Positions|Effect of Cosopt treatment on blood pressure changes in sitting to supine positions.|10 weeks||||mmHg||Standard Deviation|Mean
1443760|NCT00906087|Primary|Intraocular Pressure in Sitting and Supine Positions.|Effect of Cosopt treatment on intraocular pressure changes in sitting to supine positions.|10 weeks||||mmHg||Standard Deviation|Mean
1443761|NCT00906074|Secondary|Number of Participants With Antimicrobial Resistance|Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Number of participants|||Number
1443762|NCT00906074|Secondary|Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)|Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Percentage of participants|||Number
1443763|NCT00906074|Secondary|Classification of SSI Infection|Participants with organ-space or deep incisional SSI.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||participants|||Number
1443764|NCT00906074|Secondary|ASEPSIS Classification in Participants With Serious SSI|Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay in hospital prolonged over 14 days (ASEPSIS). ASEPSIS classification is a numerical indication of wound healing progress: satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (20-30), moderate wound infection (30-40), and severe wound infection (over 40).|Up to 30 days post surgery|Subset of study population with infection|||participants|||Number
1443765|NCT00906074|Secondary|Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0|Percentage of participants with NNISS score for increased preoperative risk of infection.|Baseline (pre-surgical)|Study population|||Percentage of participants|||Number
1443766|NCT00906074|Primary|Percentage of Participants With Post-surgical Drainage||Day 0 (day of surgery) up to 30 days post surgery|Study Population|||Percentage of participants|||Number
1443767|NCT00906074|Primary|Percentage of Participants Who Showed Clinical Improvement of SSI|Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Percentage of participants|||Number
1443768|NCT00906074|Primary|Percentage of Participants With Infection|Microorganism infection by bacterial type.|Day 0 (day of surgery) up to 30 days post surgery|Subset of study population with infection; N=number of participants with evaluable data|||Percentage of participants|||Number
1443769|NCT00906074|Primary|Type of Surgeon|Surgical speciality of physician who performed surgery.|Day 0 (day of surgery)|No data collected|||surgeon|||Number
1443770|NCT00906074|Primary|Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty|Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin. Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds. Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.|Day 0 (day of surgery)|Study population|||Percentage of participants|||Number
1443771|NCT00906074|Primary|Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery||Day 0 (day of surgery)|Study Population|||Percentage of participants|||Number
1443772|NCT00906074|Primary|Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis||Baseline (Pre-surgical)|Study Population|||Percentage of participants|||Number
1443773|NCT00906074|Primary|Percentage of Participants With Pre-surgical Morbidities|Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared [BMI kg/m2]) greater than (>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin [Hb] less than (>) 9 grams per deciliter [gr/dL]) or malnutrition (hypoalbuminemia).|Baseline (Pre-surgical)|Study population: participants with or without SSI after surgery, treated in major hospitals with general surgical units located in Spain|||percentage of participants|||Number
1443774|NCT00906035|Secondary|Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Reporting Blood Oxygenation.|Reporting blood oxygenation. Data could not be analyzed due to insufficient number of participants enrolled. Difficulty finding participants who fit into the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180.|Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.||||||
1443775|NCT00906035|Secondary|Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Blood Flow Reporting to Added Table.|Done by doppler ultrasound. Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180.|Data could not be analyzed due to insufficient number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.||||||
1443776|NCT00906035|Primary|The Present Study is Designed to Explore Two Potential Mechanisms Which Have Been Linked to Dipyridamole Action on the Vessel Wall; Modulation of Vascular Eicosanoid Generation and Prevention of Oxidant Stress.|No analysis could be performed due to the insufficent number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.|Predose and dosing days 30, 90 and 180|Data could not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria. Data could not be analyzed due to insufficient number of participants enrolled.||||||
1443777|NCT00905840|Secondary|Soft Tissue and Safety Assessments|"Modified Plaque Index (mPI) and modified Sulcus Bleeding Index (mSBI) according to Mombelli at al. (1987). Assessment to be perform at four sites per implant: lingual, buccal, mesial, and distal.~mPI: 0=no plaque detected, 1=plaque only recognized by running a probe across the smooth marginal surface of the implant, 2=plaque can be seen by the naked eye, 3=abundance of soft matter.~mSBI: 0=no bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant, 1=isolated bleeding spot visible, 2=blood forms a confluent red line on margin, 3=heavy or profuse bleeding.~Safety evaluations including recording of all complications, adverse events (AEs), and serious adverse events SAEs). Each AE and SAE will be assessed for severity and its potential relationship to the study device."|after 12, 24, and 36 month|"The numbers represent subjects that are classified as Yes. mPI: if all 4 evaluated scores are 0 or 1, the mPI will be classified as No. If at least one score is 2 or 3, mPI will be classified as Yes.~mSBI: if all evaluated scores are 0 or 1, mSBI will be classified as No. If at least one score is 2 or 3, mSBI will be classified as Yes."|||participants|||Number
1443778|NCT00905840|Secondary|Success and Survival Rate of Both Study Implants Titanium Grade IV and Titanium Zirconium) According to Definition by Buser et al. 1990|"split-mouth design~Implant success and survival rate according the definition by Buser et al. 1990 are:~Absence of persistent subjective complaints, such as pain, foreign body sensation and/or dysaesthesia~Absence of a recurrent peri-implant infection with suppuration~Absence of mobility~Absence of a continuous radiolucency around the implant~Possibility for restoration"|at 12, 24 and 36 months post surgery|The analysis was determined as Intent To Treat (ITT). The study population consisted of each randomized patient who received the device.|||implants|Participants||Number
1443779|NCT00905840|Primary|Change in Crestal Bone Level Between Surgery and 12 Months, to Compare Between the Titan Zircon Implant and the Titan Grade IV Implant.|"Panoramic radiographs with standardized setting were taken at the implant surgery and after 12 month. Digital images were analyzed using Image J 1.33 open software and film-based images were digitalized via a video camera, light box and an image analysis program, as described by Braegger (1998; Braegger at al. 2004). All images were analyzed by an independent investigator who was blind to the implant material.~The implant length was used as a reference measurement, and the implant chamfer 0.2 mm above the implant shoulder was used as the reference line for the bone-level measurement. Bone level was, therefore, defined as the distance from the reference point to the first bone-to-implant contact; mesial and distal bone-level changes in this region were considered as remodeling. Mesial and distal measurements were recorded and the mean of the two values was used."|12 months|The Intent To Treat (ITT) populaton consisted of all randomized patients who received implants and who underwent at least one efficacy assessment.|||mm|Participants|Full Range|Mean
1443780|NCT00905827|Secondary|Satisfaction With Training|Evaluation included 20 standard items assessing providers satisfaction with training, including items similar to other published satisfaction surveys. Survey items were rated using a five-point Likert scale indicating the degree to which respondents agreed or disagreed. Questions were always phrased positively so that agree or strongly agree is equivalent to a positive response.|post-training||||participants|||Number
1443781|NCT00905827|Primary|Provider Self-efficacy and Beliefs About Suicidality|Assessed beliefs and confidence in managing suicidal individuals. Using a 5-point Likert scale, there were 11 items that addressed the following: competence, reactions, beliefs, motivations, and CAMS as it relates to their practice. Scores ranged from 11-55 with questions were phrased so higher scores indicated more positive views.|post-training||||units on a scale||Standard Error|Mean
1443782|NCT00905632|Secondary|Number of Participants With Discontinuations Due to AEs|Number of participants with adverse events (AEs) leading to discontinuation of trial drug|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||participants|||Number
1443783|NCT00905632|Secondary|Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG|Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events.|From the start of the study to Day 30 (2 days after last dose)|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||participants|||Number
1443815|NCT00905515|Primary|Change in Risk Factors for Cardiovascular Morbidity and Chronic Graft Dysfunction as Evidenced by Blood Levels of Homocysteine and Transforming Growth Factor Beta (TGF-B)||6 months, 1 year, 2 years, 3 years|||||||
1443784|NCT00905632|Secondary|RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax.|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1443785|NCT00905632|Secondary|t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||hour||Geometric Coefficient of Variation|Geometric Mean
1443786|NCT00905632|Secondary|λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1443787|NCT00905632|Secondary|AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose|5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443788|NCT00905632|Secondary|C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose|C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h).|654 hours after drug administration on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443789|NCT00905632|Secondary|Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168|Cpre,N [ng/mL] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below.|5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443790|NCT00905632|Secondary|AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168|30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1443791|NCT00905632|Secondary|Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|tmax [h] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state).|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||hour||Geometric Coefficient of Variation|Geometric Mean
1443792|NCT00905632|Secondary|Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State)|Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168|5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443793|NCT00905632|Secondary|Plasma Concentration Time Profiles of CD 6168|Plasma concentration time profiles of CD 6168|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443811|NCT00905567|Primary|AUC0-72 - Area Under the Concentration Time Curve From Time Zero to Time 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443794|NCT00905632|Secondary|Plasma Concentration Time Profiles of BI 207127|Plasma concentration time profiles of BI 207127|0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443795|NCT00905632|Secondary|Number of Participants With Sustained Virological Response|Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (<10 IU/mL) at least 85 days after stopping standard care (SOC).|Until end of treatment, up to 570 days|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
1443796|NCT00905632|Secondary|Number of Participants With End of Treatment Response|Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders* - Response = Viral load below the limit of detection at end of all treatment.|Week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
1443797|NCT00905632|Secondary|Number of Participants With Early Virological Response|Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84)|Baseline and week 12|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
1443798|NCT00905632|Secondary|Number of Participants With Rapid Virological Response|Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28.|4 weeks|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
1443799|NCT00905632|Secondary|Number of Participants With Virologic Response at Day 28|Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), <10 IU/mL, at day 28|day 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy.|||Participants|||Number
1443800|NCT00905632|Secondary|Viral Load at Each Visit up to Day 28|Viral load (VL) (original values) at each visit up to day 28.|Baseline and days 8, 15, 22 and 28|Pharmacodynamic (PD) set which included patients in the treated set but excluded VL values after recorded treatment stop time and values after subjects took wrong or additional doses of treatment. Also one patient was excluded from all descriptive PD summaries due to a protocol violation and another excluded as they did not have a predose VL value.|||IU/mL||Full Range|Median
1443801|NCT00905632|Secondary|Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline|"Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit.~A negative value represents an increase in viral load, a positive value represents a decrease in viral load."|Baseline and days 1, 2, 4, 8, 15, 22 and 28|Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available viral load data at baseline and day 28.|||IU/mL||Full Range|Median
1443802|NCT00905632|Primary|Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.|The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir.|Baseline and 4 weeks|Full Analysis Set (FAS): The subset of patients in the treated set (TS) that had at least one measurement of efficacy.|||Participants|||Number
1443803|NCT00905606|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443804|NCT00905606|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours (Per Participant)|Bioequivalence based on AUC0-72|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443805|NCT00905606|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443806|NCT00905580|Primary|Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively||1, 6, 24 & 48 hours||||participants|||Number
1443807|NCT00905580|Secondary|Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.|we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.|3 months||||participants|||Number
1443808|NCT00905580|Primary|The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.|Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. We asked patients about sedation, headache, dizziness, blurred vision.|1, 6, 24 & 48 hours||||participants|||Number
1443809|NCT00905580|Primary|Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.|Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0–10 VNRS, where 0 means no pain at all, and 10 represents the worst pain imaginable|1, 6, 24 & 48 hours||||VNRS||Inter-Quartile Range|Median
1443810|NCT00905567|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from all subjects who completed the study was used in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443818|NCT00905489|Other Pre-specified|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Last Available Visit|Patients maintaining a viral load < 50 copies/mL at the last available visit|Last available visit, up to 155 weeks|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase with VL data available|||percentage of patients|||Number
1443819|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL in Optional Extension Phase|Patients maintaining a viral load < 400 copies/mL at week 24 of the Optional Extension Phase (OEP)|week 24|Full analysis set including patients with available viral load data at week 24|||percentage of patients|||Number
1443820|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL at Week 24 of Optional Extension Phase|Patients maintaining a viral load < 50 copies/mL at week 24 (approximately 168 days) of Optional Extension Phase (OEP).|week 24|Full analysis set including patients with available viral load data at week 24|||percentage of patients|||Number
1443821|NCT00905489|Secondary|Percentage Change From Baseline in Mean CD4+ Count|((Day 22 value-Baseline value)/Baseline value)*100. ((Week 24 value-Baseline value)/Baseline value)*100.|Baseline to day 22 and baseline to week 24|Optional Extension Phase Treated Set (OEP TS), all patients that complete PK phase and enroll in Extension phase, and had available data at either day 22 or week 24.|||percentage change||Standard Deviation|Mean
1443822|NCT00905489|Secondary|Change From Baseline in Mean CD4+ Count (Absolute)|Change in mean CD4+ count (absolute) from baseline to Day 22 and from baseline to Week 24.|Baseline, Day 22 and week 24|PK Analysis set: This patient set includes all patients in the Full Analysis Set (FAS) that have no protocol violations excluding them from PK analysis.|||cells/mm^3||Standard Deviation|Mean
1443823|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 400 Copies/mL|Patients maintaining a viral load < 400 copies/mL at Day 22|Day 22|Full analysis set including patients with available viral load data at day 22|||percentage of patients|||Number
1443824|NCT00905489|Secondary|Efficacy: Patients Maintaining a VL < 50 Copies/mL|Patients maintaining a viral load < 50 copies/mL at Day 22.|Day 22|Full analysis set including patients with available viral load data at day 22|||percentage of patients|||Number
1443825|NCT00905489|Secondary|Cavg|Average measured concentration of the Nevirapine in plasma at steady state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443826|NCT00905489|Secondary|CL/F,ss|Apparent clearance of the Nevirapine in the plasma after extravascular administration at steady-state Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
1443827|NCT00905489|Secondary|Tmax,ss|"Time from dosing to the maximum concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.~The standard deviation is actually the coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||hours||Standard Deviation|Mean
1443828|NCT00905489|Secondary|%PTF|Percentage peak-trough Nevirapine fluctuation, % fluctuation (degree of peak to trough fluctuation) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
1443829|NCT00905489|Secondary|Ratio Cmax,ss/Cmin,ss|Ratio of (maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ)/(minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ) Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
1443830|NCT00905489|Secondary|Cmax,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Maximum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443831|NCT00905489|Secondary|Cmin,ss (for IR and XR Formulations by Nevirapine XR Dose Group)|Minimum measured concentration of the Nevirapine in plasma at steady state over the time dosing interval τ by nevirapine XR dose group Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 21.|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1443832|NCT00905489|Secondary|AUCt,ss|"Area under the concentration-time curve of the Nevirapine (NVP) in plasma at steady state over the time dosing interval τ.~All patients received nevirapine IR for 10 days prior to collection of 12-hour Area Under the Curve (AUC) data. Then, all patients were switched to nevirapine XR for 9 days prior to collection of 24-hour AUC data. The treatments of IR and XR are summarized separately using geometric means and geometric coefficients of variation.~For NVP IR AUC measured over hours: 0,1,2,3,4,8 and 12, For NVP XR AUC measured over hours: 0,1,2,3,4,8,10,12 and 24."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|Intensive PK analysis set (IPK): This patient set includes all patients in the PK set that underwent intensive PK sampling.|||ng*h/ml||Geometric Coefficient of Variation|Geometric Mean
1443833|NCT00905489|Primary|Trough Cpre,N.|"Trough Nevirapine concentration immediately prior to the next scheduled dose. Patients took Nevirapine (NVP) Immediate Release (IR) up to day 10 and had PK measurements taken on Day 11. This was followed by 9 days (from day 12 to day 20) taking NVP Extended Release (XR) with PK measurements taken on Day 22.~The measure of dispersion presented is the coefficient of variation (%) rather than the geometric coefficient of variation."|Day 11 prior to the next scheduled dose of Nevirapine IR and day 22 prior to the next scheduled dose of Nevirapine XR|PK analysis set (PKS): This patient set includes all patients in the Full Analysis Set (FAS) set that have no protocol violations excluding them from PK analyses.|||(ng/mL/mg)||Geometric Coefficient of Variation|Geometric Mean
1443834|NCT00905437|Secondary|Number of Participants With Neuropathic Pain|"ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. Yes response to questions 1-5 were scored as 1, while a yes response to question 6 was scored as -1. No response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported."|Day 90, Day 180 post-surgery|Data was not analyzed as the intended sample size was not met, and the reported numbers from the final set were not sufficient for a meaningful analysis.||||||
1443835|NCT00905437|Secondary|Number of Participants With Rescue Medication Usage|Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications.|Day 0 to Day 6 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications.|||participants|||Number
1443836|NCT00905437|Secondary|Time to Mobilization After Surgery|Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Inter-Quartile Range|Median
1443837|NCT00905437|Secondary|Mean Anxiety Visual Analogue Scale (A-VAS)|Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious.|Day 0 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||Units on a scale||Standard Error|Mean
1443838|NCT00905437|Secondary|Mean Daily Sleep Interference Score|Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication.|Day 1 to Day 5 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||Units on a scale||Standard Error|Mean
1443839|NCT00905437|Secondary|Mean Daily Pain Score|Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain.|Day 1 to Day 7, Day 8 to Day 14 post-surgery|MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure. ‘n’ signifies participants who were evaluable for this measure at specified time-point for each arm.|||Units on a scale||Standard Error|Mean
1443840|NCT00905437|Primary|Mean Pain on Movement Score|Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain.|Every 12 hours from Day 1 to Day 5 post-surgery|Modified Intent to Treat (MITT) population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. ‘N’ (number of participants analyzed) signifies participants who were evaluable for this measure.|||Units on a scale||Standard Error|Mean
1443841|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1444037|NCT00904215|Secondary|Change in VAS (Visual Analog Scale)|VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)|between baseline (visit 1) and after 12 weeks of treatment (visit 3)||||Units on a scale||Standard Deviation|Mean
1443842|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1443843|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6|BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.|Augmentation baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1443844|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|FAS|||Percent of participants|||Number
1443845|NCT00905424|Secondary|Assessment in Remitters of CGI-S at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation Baseline|FAS|||Percent of participants|||Number
1443846|NCT00905424|Secondary|Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|FAS|||Percent of participants|||Number
1443847|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1443848|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline and 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1443849|NCT00905424|Secondary|Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline and 6 weeks|Full Analysis Set (FAS) defined as all subjects who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.|||Units on a scale||Standard Error|Least Squares Mean
1443850|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
1443851|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
1443852|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6|BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.|Augmentation Baseline and 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
1443853|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|6 weeks|Primary Efficacy Analysis Set|||Percent of participants|||Number
1443854|NCT00905424|Secondary|Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Augmentation baseline|Primary Efficacy Analysis Set|||Percent of participants|||Number
1443855|NCT00905424|Secondary|Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|6 weeks|Primary Efficacy Analysis Set|||Percent of Participants|||Number
1443856|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
1444031|NCT00904371|Primary|Change From Baseline in Framingham Stroke Risk Assessment Score|The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||units on a scale||Standard Deviation|Mean
1443857|NCT00905424|Secondary|Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF|The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0–7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set|||Units on a scale||Standard Error|Least Squares Mean
1443858|NCT00905424|Primary|Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Augmentation Baseline, 6 weeks|Primary Efficacy Analysis Set defined as all non-remitters (MADRS total score greater than 10 at augmentation baseline) who take at least 1 dose of randomized augmentation treatment and have at least 1 primary efficacy measurement after randomization.|||Units on a scale||Standard Error|Least Squares Mean
1443859|NCT00905359|Secondary|Number of Patients With Improvement of Symptoms, Symptoms Recurrence, Decreased Therapeutic Response, no Therapeutic Response and Treatment Failure at 14 Days, 6 Weeks, 6, 12 and 24 Months||14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||participants|||Number
1443860|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Symptom Severity||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
1443861|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-ZCQ Physical Function||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
1443862|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-leg Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
1443863|NCT00905359|Secondary|Correlation Between Changes in Spinal Central Canal Stenosis and Changes in Patient Reported Outcomes-Back Pain||12 months and 24 months|Intention to treat population analysis: all randomized patients who were operated, and had at least one post-operative assessment.|||correlation coefficient|||Number
1443864|NCT00905359|Secondary|Bony Structure Changes of Spinous Process Assessed by CT at the Follow-up Time Points|Number of subjects who had abnormal bony structure of Spinous process was reported for bony structure changes of Spinous process assessed by CT at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||participants|||Number
1443865|NCT00905359|Secondary|Changes in Stenosis of the Spinal Canal Assessed by Magnetic Resonance Imaging (MRI) at the Follow-up Time Points|The lumen sizes of the spinal central canal were reported for the changes in stenosis of the spinal canal assessed by Magnetic Resonance Imaging (MRI) at the follow-up time points.|baseline, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||mm^2||Standard Deviation|Mean
1443866|NCT00905359|Secondary|Percentage of Subjects With Serious Adverse Device Effects||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).|||percentage of subjects|||Number
1443867|NCT00905359|Secondary|Number of Subjects Requiring Secondary Surgical Intervention||Overall study period, up to 24 months|Safety population: All patients who were operated within this study (either by an APERIUS® procedure or by SDS).|||participants|||Number
1443868|NCT00905359|Secondary|Mean Percentage Changes From Baseline in Quality of Life Using the Patient-completed SF-36 Questionnaire|The SF-36 questionnaire was used to assess the quality of life. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life. Mean percentage changes of SF-36 PCS and MCS from baseline are reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage of change from baseline||Standard Deviation|Mean
1443869|NCT00905359|Secondary|Mean Percentage Change of Visual Analog Scale (VAS) From Baseline in Leg Pain|Patients rated their leg pain using Visual Analog Scale (VAS) from 0 to 10, higher values represents a worse pain. Mean percentage change of VAS scores from baseline in leg pain is reported.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage of change from baseline||Standard Deviation|Mean
1443870|NCT00905359|Secondary|Patient Satisfaction (PS) Scores of Zurich Claudication Questionnaire|PS score is the mean score of 6 questions of ZCQ, ranging from 1 to 4 if the number of responses exceeded four. A lower score represents a better outcome. Patients with PS score less than 2.5 at postoperative evaluation were considered positive, which implied that patients were satisfied with their treatment.|14 days, 6 weeks, 6 months, 12 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||units on a scale||Standard Deviation|Mean
1443908|NCT00905125|Primary|Number of Participants Reporting Fever Based on the Protocol-defined Grading Scale for Oral Temperature|Participants recorded a daily oral temperature on a memory aid for 8 days (Days 0-7) after vaccination. The protocol defined mild fever as oral temperatures 37.8 to less than 38 degree Celsius, moderate fever as 38 to less than 39 degrees Celsius and severe fever as oral temperatures of 39 degrees Celsius or higher. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
1443871|NCT00905359|Secondary|Mean Percentage of Change From Baseline in Symptom Severity of the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment PS. SS Score is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance) in ZCQ. The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire, ranging from 1 to 5. A lower score represents a better outcome/condition. Mean percentage of change from baseline in Symptom Severity is reported.|14days, 6 week, 6 months, 12 months, 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage change from baseline||Standard Deviation|Mean
1443872|NCT00905359|Secondary|Mean Percentage Change From Baseline in Physical Function, Using Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 14 days, 6 weeks, 6 months, and 24 months was reported.|14 days, 6 weeks, 6 months, and 24 months|Per-protocol population analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage change from baseline||Standard Deviation|Mean
1443873|NCT00905359|Primary|Mean Percentage Change From Baseline in Physical Function at 1 Year Follow-up Using the Patient Completed Zurich Claudication Questionnaire|ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: Physical function (PF), Symptom Severity (SS), and post-treatment Patient Satisfaction (PS).PF score is the mean score of five physical function questions of ZCQ, ranging from 1 to 4. A lower score represents a better outcome/condition. Mean percentage change from baseline in Physical Function at 1 year follow-up was reported.|1 year|Per-protocol analysis (subjects who were not performed surgical procedure as assigned per randomization were excluded).|||percentage change from baseline||Standard Deviation|Mean
1443874|NCT00905346|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443875|NCT00905346|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443876|NCT00905346|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443877|NCT00905307|Secondary|Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712|Efficacy-related discontinuation rate was assessed|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Percentage of participants|||Number
1443878|NCT00905307|Secondary|Response Rate at Week 6|Response rate was defined as a reduction of ≥ 30% from baseline in PANSS Total Score; or a CGI–I score of 1 (very much improved) or 2 (much improved) at Week 6|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impuite missing data.|||Percentage of participants|||Number
1443879|NCT00905307|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) at Week 6|The rater or investigator rated the particpant’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant’s condition at baseline prior to the first dose of double-blind study medication. Response choices included the following: 0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1443880|NCT00905307|Secondary|Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)|The severity of illness for each participant was rated using the CGI–S. To perform this assessment, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices include the following: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1443881|NCT00905307|Secondary|Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains. The rating is based on four main areas: (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. The ratings are converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater’s judgment to determine the total score within the 10-point interval. Ratings from 71-100 reflect only mild difficulties. Ratings from 31-70 reflect manifest disabilities of various degrees. Ratings from 1-30 reflect functioning so poor that intensive support or supervision is needed.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1444036|NCT00904215|Primary|Change in WHO-QOL (WHO-Quality Of Life)|"World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed.~Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)"|between baseline (visit 1) and after 12 weeks of treatment (visit 3)||||Units on a scale||Standard Deviation|Mean
1443882|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. PANSS negative subscale score is the sum of the rating scores for the 7 negative scale items from the PANSS panel. The PANSS negative subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1443883|NCT00905307|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. The positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS positive subscale score is the sum of the rating scores for the 7 positive scale items from the PANSS panel. The PANSS positive subscale score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1443884|NCT00905307|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)|The PANSS consists of three subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS total score is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline to Week 6|Consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. The last observation carried forward (LOCF) method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1443885|NCT00905268|Secondary|Change in Peak Workload From Baseline to Week 52|"Assessed by a modified exercise test, in a subset of patients able to undertake this.~Wpeak has been calculated from the following formula: Workload last fully completed stage + (seconds completed in last stage / 60 * (4 [if arm ergonometry] or 10 [if leg ergonometry]))."|1 year||||Watts||Standard Deviation|Mean
1443886|NCT00905268|Secondary|Change in Peak Systolic Strain Rate From Baseline to Week 52|Mean Change of Peak systolic longitudinal strain rate (PSLSR) from Baseline to Week 52 in subjects with cardiac involvement (FRDA-CM criteria), where positive value in PSLSR is a deterioration and negative value an improvement.|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)|||1/s||Standard Deviation|Mean
1443887|NCT00905268|Secondary|Proportion of Patients Improving on Left Ventricular Peak Systolic Strain Rate or Showing a Reduction in Left Ventricular Mass Index (LVMI) With no Worsening in Strain Rate|(In the statistical analysis sub-population presenting with cardiac involvement as defined by the FRDA cardiomyopathy criteria)|1 year|Subgroup of subjects with cardiac involvement as defined by Friedreich’s ataxia cardiomyopathy (FRDA-CM)|||percentage of patients|||Number
1443888|NCT00905268|Secondary|Proportion of Patients Improving (Responding) on ICARS by a Clinically Relevant Margin|"The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.~ICARS Responder Analysis at Week 52: Percentage of subjects Improving by 2.5 Points or More."|week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.|||percentage of patients|||Number
1443889|NCT00905268|Secondary|Absolute Change in Friedreich's Ataxia Rating Scale (FARS) Scores From Baseline Assessment to Week 52|The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, and activities of daily living subscale and a neurological subscale. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|Baseline and week 52|The comparison was carried out in the ITT population, on data imputed using the last observation carried forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1443890|NCT00905268|Primary|Absolute Change in International Cooperative Ataxia Rating Scale (ICARS) Scores From Baseline Assessment to Week 52|The International Cooperative Ataxia Rating Scale (ICARS) is a commonly used evaluation and is composed of four clinical sub-scores involving the following: posture and gait, limb coordination, speech and oculomotor function.The ICARS score is the total sum of the sub scores and ranges from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline and week 52|The Intent-To-Treat (ITT) population included all randomized subjects who received at least one dose of the study medication and had a confirmed diagnosis of FRDA, did not take idebenone within one month pre-Screening or between Screening and Visit 1, and were not under idebenone treatment at Baseline according to available PK results at Visit 1.|||units on a scale||Standard Deviation|Mean
1443909|NCT00905125|Primary|Number of Participants Reporting Solicited Systemic Symptoms at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which systemic symptoms of feverishness, malaise, myalgia, headache and nausea were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
1443891|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for All Patients During On-Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||participants|||Number
1443892|NCT00905255|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period and “n” = patients with FPG assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||mmol/L||Standard Deviation|Mean
1443893|NCT00905255|Secondary|Change From Baseline in Body Weight for All Patients at Week 52 and 76|Change was calculated by subtracting baseline value from value at week of assessment (Week 52/Week 76). The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline weight assessment during on-treatment period and “n” = patients with weight assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||kilogram||Standard Deviation|Mean
1443894|NCT00905255|Primary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of the One-Step and Two-Step Titration Arms Assessed Through Adverse Events Collection and Vital Signs, Electrocardiogram (ECG) and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with treatment emergent adverse events (TEAEs) during the 24-week treatment period: any TEAE; any serious TEAE; any TEAE leading to death; and any TEAE leading to permanent treatment discontinuation.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||percentage of participants|||Number
1443895|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
1443896|NCT00905255|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 52 and 76|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
1443897|NCT00905255|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) for All Patients at Week 52 and 76|Absolute change = HbA1c value at week of assessment (Week 52/Week 76) minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 52, 76|mITT population. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period and “n” = patients with HbA1c assessment for the specified category. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of hemoglobin||Standard Deviation|Mean
1443910|NCT00905125|Primary|Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness at Each Grade|Participants recorded a daily measured value of swelling and redness, if present. The protocol defined grading of small, medium and large, with small as less than 20 mm, medium as 20-50 mm and large as greater than 50 mm. Participants are counted at the largest measured grade experienced across the 8 day period after vaccination.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
1444038|NCT00904215|Primary|Change in DBP (Diastolic Blood Pressure)|The change of the mean DBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)||||mmHg||Standard Deviation|Mean
1443898|NCT00905255|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia for the One-Step and Two-Step Titration Arms During 24-Week Treatment Period|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose of study drug at Week 24 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1443899|NCT00905255|Other Pre-specified|Percentage of Patients Requiring Rescue Therapy|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 4 to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%, from Week 24 to end of treatment (Week 76): fasting SMPG/FPG >180 mg/dL (10.0 mmol/L) or HbA1c >8%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 52, Baseline up to Week 76|mITT population.Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
1443900|NCT00905255|Secondary|Overview of Adverse Event Profile (Treatment Emergent Adverse Events) of All Patients During On-Treatment Period Assessed Through Adverse Events Collection and Vital Signs, ECG and Laboratory Monitoring|Overview of adverse event profile is reported in terms of percentage of patients with TEAEs during the on-treatment period: any TEAE; any serious TEAE; any TEAE leading to death; any TEAE leading to permanent treatment discontinuation. The on-treatment period was the time from the first dose of study drug up to 3 days after the last dose at Week 76.|First dose of study drug up to 3 days after the last dose of study drug at Week 76 or early withdrawal|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered. Analysis was done on the overall group (pooled data from the 2-step and 1-step titration arms) as pre-specified|||percentage of participants|||Number
1443901|NCT00905164|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443902|NCT00905164|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443903|NCT00905164|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443904|NCT00905151|Primary|Performance of Glomerular Filtration Rate (GFR) Estimating Equations|Overall bias, median difference (95% confidence interval), mL/min per 1.73 m^2, assessed as the median difference between the measured and estimated GFR across all estimated GFR levels, with positive values indicating an underestimation of measured GFR.|Blood samples for plasma iohexol clearance were taken at approximately 10, 30, 120, and 240 minutes post-iohexol dose.||||mL/min per 1.73 m^2||95% Confidence Interval|Median
1443905|NCT00905125|Primary|Number of Participants With a Four-fold or Greater Rise in HAI Antibody Titer Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. A participant met the threshold of a four-fold increase in titer if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.|||Participants|||Number
1443906|NCT00905125|Secondary|Microneutralization Assay Geometric Mean Antibody Titers Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.|||Participants|||Number
1443907|NCT00905125|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against Each Antigen in the 2008-2009 Seasonal Influenza Trivalent Influenza Vaccine|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.|||Titer||95% Confidence Interval|Mean
1443938|NCT00904969|Post-Hoc|Uroflow Studies: Average Flow Rates|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 Month|Number of subjects that did not have test performed at follow-up visit.|||ml/sec||Standard Deviation|Mean
1443911|NCT00905125|Secondary|Number of Participants With a Four-fold or Greater Rise in Microneutralization Antibody Titer Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen. The threshold of a four-fold increase in titer would be met if the Day 0 titer was less than 10 (the assay's lowest level of detection) and the Day 28 titer was 40 or greater, or the Day 0 titer was greater than or equal to 10, and the Day 28 titer was an increase by four-fold or more.|Day 0 prior to and Day 28 receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.|||Participants|||Number
1443912|NCT00905125|Secondary|Number of Participants With a Serum Microneutralization Antibody Titer of Greater Than or Equal to 40 Against Each Antigen in the 2008-2009 TIV|Blood was collected for microneutralization assay at Day 0 prior to vaccination and again at 28 days following vaccination. The microneutralization assay was to be conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving a single dose.|Microneutralization assays were deemed not necessary by the sponsor and conduct of these assays is not planned.|||Participants|||Number
1443913|NCT00905125|Primary|Number of Participants Reporting Solicited Injection Site Reactions at Each Severity Based on the Functional Grading Scale|Participants recorded a daily maximum severity at which local reactions of pain, tenderness and swelling were experienced. Mild reactions had no interference with daily activities, moderate reactions interfered with daily activity, and severe reactions were defined as preventing daily activity. Participants are reported at the highest severity experienced across the 8 days.|Days 0-7 after vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
1443914|NCT00905125|Primary|Number of Participants Reporting Unsolicited Non-serious Adverse Events Considered Associated With Vaccination|Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.|Day 0 through Day 28 post vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
1443915|NCT00905125|Primary|Number of Participants Reporting Serious Adverse Events (SAE)|Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes. All events are included regardless of association to vaccination.|Through 6 months post vaccination.|All participants are included in the ITT safety population for this outcome measure.|||Participants|||Number
1443916|NCT00905125|Primary|Number of Participants Reporting Neonatal Complications.|Participants were contacted after delivery, and medical records reviewed, to collect neonatal complications. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All live births are included in this outcome measure, which excludes three participants whose pregnancies ended in miscarriage or stillbirth (reported as maternal complications). Three participants gave birth to twins, who are each counted separately.|||Participants|||Number
1443917|NCT00905125|Primary|Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.|Participants were contacted after delivery, and medical records reviewed, to collect complications experienced during pregnancy, labor and delivery. The data collection process followed a prospectively-defined list of complications reported for this outcome measure, some of which may have also been reported as serious adverse events if otherwise meeting those requirements.|At time of delivery.|All participants from whom outcome data were collected are included in the ITT safety population for this outcome measure.|||Participants|||Number
1443918|NCT00905125|Primary|Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV)|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.|Day 0 prior to and Day 28 after receiving single dose.|Participants are included in this ITT analysis if blood was collected at both timepoints. One participant was excluded because the baseline blood draw was done after vaccination.|||Participants|||Number
1443919|NCT00905034|Primary|Complete Response (CR) Rate|Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.|6 cycles (cycle = 28 days)|Of the 37 participants enrolled, 36 participants completed therapy and were evaluable for response.|||percentage of participants|||Number
1443920|NCT00905021|Secondary|Study Molecular Changes in Tissue Biopsies, Circulating Tumor Cells, and Circulating Endothelial Cells||5 years|||||||
1443921|NCT00905021|Secondary|Determine the Safety and Tolerability||5 years|||||||
1443922|NCT00905021|Secondary|Obtain Assessments of Overall Response Rate, Clinical Benefit Rate, and Overall Survival||5 years|The study was terminated early before target accrual.||||||
1443923|NCT00905021|Primary|Time to Disease Progression in Weeks|Time from the first day of treatment to date of progression in weeks|Medical evaluation every 4 weeks;The study does not have a fixed time frame for each participant. Duration of therapy depends on individule response, evidence of disease progression and tolerance|2 patients developed disease progression.|||week||Full Range|Mean
1443939|NCT00904969|Post-Hoc|Uroflow Studies: Peak Flow Rate|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 month|Number of subjects that did not have test performed at follow-up visit.|||ml/sec||Standard Deviation|Mean
1443924|NCT00904995|Primary|Percentage of Samples With BG Levels > 60pg/ml|"Rate calculated as number of participants with positive levels divided by total number of participants. beta-d-glucan (BG), a cell wall constituent of fungi, can be detected in serum as a marker of Invasive fungal infections (IFI).~Blood samples were drawn on first 2 days of treatment at baseline (before the drug) and at 1, 2, 4, 8 hours after the first dose of the day. BG serum levels were measured using the Fungitell assay, using a cut off value of 60 pg/ml for positivity."|Up to 42 days|Analysis was intent to treat with a total of 182 samples (mean 8.6 samples/participant) drawn from participants.|||percent of blood samples|Participants||Number
1443925|NCT00904982|Primary|Improved Warfarin Adherence/% Timeout of Target INR Range||six months|This analysis required multiple INR results. If those were not available for a subject, they were excluded from the primary analysis.|||percentage of out of target INR range||Inter-Quartile Range|Median
1443926|NCT00904969|Secondary|Procedural and Device Complication Rates|Percentage of participants with serious and non-serious adverse events.|Procedure to 24 Months Post implant||||percentage of participants|||Number
1443927|NCT00904969|Secondary|Subject Satisfaction Endpoint: Physician Evaluation of Subject’s Incontinence Status|Physician evaluation of subject’s incontinence status at 6 weeks and subsequent follow-up evaluations|6 Weeks post implant to 24 Months||||Participants|||Count of Participants
1443928|NCT00904969|Secondary|Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores|Improvement in the subject’s quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||score||Standard Deviation|Mean
1443929|NCT00904969|Post-Hoc|Urodynamic Results: Abdominal Leak Point Pressure|Abdominal leak point pressure (ALPP) is one indicator of improvement in continence symptoms. Abdominal leak point pressure was collected at baseline and 6-month follow-up as part of the urodynamic assessment.|Baseline and 6 Months Post Implant|18 participants did not have 6-month follow-up data|||participants|||Number
1443930|NCT00904969|Post-Hoc|Urodynamics Results: Abnormal Cystometrogram, Abnormal End Fill Pressure|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Abnormal graphical representation of bladder pressure during urodynamics testing which is when the bladder is filled with saline water."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H2O||Standard Deviation|Mean
1443931|NCT00904969|Post-Hoc|Urodynamics Results: Detrusor Instability, Max Pdet|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.~Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.~The outcome measure data table shows the Pdet for patients with detrusor instability."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H2O||Standard Deviation|Mean
1443932|NCT00904969|Post-Hoc|Urodynamics Results: Detrusor Instability, Started at Filling Volume|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.~The measure data table shows the mean volume at the start of the urodynamic measurement study for patients with detrusor instability."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
1443933|NCT00904969|Post-Hoc|Urodynamics Results: Pdet at Qmax|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H20||Standard Deviation|Mean
1443934|NCT00904969|Post-Hoc|Urodynamics Results: Maximum Detrusor Pressure|"Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.~Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water."|Baseline and 6 Months Post Implant|Number of subjects that did not have test performed at follow-up visit.|||cm H2O||Standard Deviation|Mean
1443935|NCT00904969|Post-Hoc|Urodynamic Results: Bladder Capacity|Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.|Baseline and 6 Months Post implant|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
1443936|NCT00904969|Post-Hoc|Uroflow Studies: Post-Void Residual|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
1443937|NCT00904969|Post-Hoc|Uroflow Studies: Voided Volume|Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||ml||Standard Deviation|Mean
1444039|NCT00904215|Primary|Change in SBP (Systolic Blood Pressure)|The change of the mean SBP|between baseline (visit 1) and after 12 weeks of treatment (visit 3)|In clinical report form (CRF), some patients' SBP was not recorded.|||mmHg||Standard Deviation|Mean
1443940|NCT00904969|Secondary|Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores|The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject’s quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||score||Standard Deviation|Mean
1443941|NCT00904969|Secondary|Subject Satisfaction Endpoint: Quality of Life I-QOL Scores|The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.|Baseline to 24 Months|Number of subjects that did not have test performed at follow-up visit.|||score||Standard Deviation|Mean
1443942|NCT00904969|Secondary|Subject Satisfaction Endpoint: Pads Per Day Use|Summarize the subject satisfaction using pads per day use collected in follow-up in participants.|Baseline to 24 Months|LOCF and WCS data are derived from data from the 24 month visit|||Participants|||Count of Participants
1443943|NCT00904969|Secondary|Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)|Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).|Baseline to 24 Month||||participants|||Number
1443944|NCT00904969|Secondary|Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)|Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).|Baseline to 24 month||||participants|||Number
1443945|NCT00904969|Secondary|Subject Satisfaction Endpoint: 24-Hour Pad Weight|Summarize subject satisfaction with 24-hour pad weight across participants.|Baseline to 24 month|LOCF and WCS data are derived from data from the 24 month visit|||grams||Standard Deviation|Mean
1443946|NCT00904969|Secondary|Subject Satisfaction Endpoint: 1-Hour Pad Weight|Summarize subject satisfaction of 1-hour pad weight for participants.|Baseline to 24 month|Last observation carried forward (LOCF) and worst case scenario (WCS) data are derived from data from the 24 month visit|||grams||Standard Deviation|Mean
1443947|NCT00904969|Primary|Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively|Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
1443948|NCT00904969|Primary|Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning|Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
1443949|NCT00904969|Primary|Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection|Characterize procedural parameters, including muscle dissection across all participants.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
1443950|NCT00904969|Primary|Procedural Endpoint: Descriptive Procedural Parameters – Use of Tack Sutures|Characterize procedural parameters including the use of tack sutures.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
1443951|NCT00904969|Primary|Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge|Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.|post discharge||||Participants|||Count of Participants
1443952|NCT00904969|Primary|Procedural Endpoint: Rate of Foley Catheter Use - Post-operative|Number of participants requiring the use of a foley catheter who were able to void prior to discharge.|post-operative to discharge||||Participants|||Count of Participants
1443953|NCT00904969|Primary|Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative|Number of participants requiring the use of a foley catheter intra-operatively.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
1443954|NCT00904969|Primary|Procedural Endpoint: Type of Anesthesia Used|Describe the type of anesthesia used.|During Procedure, Approximately 60 Minutes||||Participants|||Count of Participants
1443955|NCT00904969|Primary|Procedural Endpoint: Procedure Time From First Incision to Closing.|Characterize procedure time from first incision to closing.|During Procedure, Approximately 60 Minutes||||minutes||Standard Deviation|Mean
1443956|NCT00904943|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443957|NCT00904943|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Mean
1443958|NCT00904943|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects that completed the study was included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1443959|NCT00904917|Secondary|Child's Report on Parental Behavior Inventory (CRPBI)|Child's Report on Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1970) assesses children's and parents’ perceptions of parental acceptance, permitting psychological autonomy, and level of parental control. The 10-item acceptance scale which assesses parental warmth was administered. The acceptable scale has items scored from 1 to 3 (not like me, somewhat like me, a lot like me). Items are summed with a total range is 10 to 30. Higher scores represents greater warmth exhibited by mother to child. Separate forms are available for both child and parent report.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the CRPBI, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).|||units on a scale||Standard Deviation|Mean
1443960|NCT00904917|Secondary|Understanding Mood Disorders Questionnaire (UMDQ)|Understanding Mood Disorders Questionnaire (UMDQ; Gavazzi, Fristad, & Law, 1997) measures attributions and knowledge of symptoms, course, and treatment of mood disorders and a symptom checklist. It has 39 items and two subscales. A range of total score is 0 to 59. The first 20 questions are true/false questions and correct responses are scored 2 points each. Nineteen questions are a checklist of symptoms and correct identification of those depression and manic symptoms are scored 1 point each. All items are summed for a total score. Higher scores indicate greater knowledge of mood disorders. Both maternal and child reporters completed this measure.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the UMDQ, which was administered to both the mothers and their children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 5 mothers and 9 children in Adapted PIP (4 participants lost to follow-up) and 6 mothers and 6 children in Lecture group (4 participants lost to follow-up).|||units on a scale||Standard Deviation|Mean
1443961|NCT00904917|Primary|Multidimensional Anxiety Scale for Children (MASC)|Multidimensional Anxiety Scale for Children (MASC; March et al., 1997) is a self-report instrument that measures a broad range of anxiety symptoms in youth. The MASC consists of 39 items using a 4-point Likert scale that are distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. Scores are summed and converted to T-scores. The total T score ranges from 25 to 90 with higher scores representing greater levels of anxiety.|Measured at baseline and post-treatment (8 weeks after baseline)|These scores are based on the MASC which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).|||T scores||Standard Deviation|Mean
1443962|NCT00904917|Primary|Children Depression Inventory (CDI)|Children Depression Inventory (CDI; Kovacs, 1992) is a widely-used self-report scale of depressive symptoms suitable for use by youth ranging from 7 to 17 years. The CDI is a 27-item scale that is self-rated and symptom-oriented. The 27 items on the assessment are grouped into five major factor areas. The item score are rated 0-2 with a total scores summed and converted to T scores. The total T score ranges from 33 to 100 with high scores indicating higher levels of depressive symptoms.|Measured at baseline and at post-treatment (8 weeks after baseline)|These scores are based on the CDI which was administered solely to the children of the dyadic mother-child intervention and control groups. Post-intervention scores based on 9 children in Adapted PIP (2 lost to follow-up) and 6 children in Lecture group (2 lost to follow-up).|||T scores||Standard Deviation|Mean
1443963|NCT00904839|Secondary|Exploratory Biomarker and Pharmacogenetic Analysis for VEGF|"Exploratory biomarker and pharmacogenetic analysis for Vascular endothelial growth factor (VEGF).~Note: This endpoint was not statistically analysed in this study."|Day 1, Day 29, Day 57, Day 85 and Day 127|||||||
1443964|NCT00904839|Secondary|Number of Participants for Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the First Use of Stoma Bag.|Number of participants for Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the first use of stoma bag.|from baseline until end of treatment, up to 892 days|Treated Set (TS).|||participants|||Number
1443965|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-CR38 for the Change From Baseline at 9 Months.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-CR38 for the change from baseline at 9 months for functional scales, Symptom scales Chemotherapy side effects .~The EORTC-QLQ-CR38 was composed of functioning scales (body image, future perspective, sexual enjoyment, sexual functioning) and symptom scales (chemotherapy side effects, defecation problems, symptoms of the gastrointestinal tract, micturition problems,female sexual problems, male sexual problems, stoma related problems, and weight loss).~Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for functional scales and a worse quality of life for symptom scales."|Baseline and 9 months.|Treated Set (TS)|||units on scale||Standard Deviation|Mean
1443966|NCT00904839|Secondary|Quality of Life Evaluation by a Standardised Questionnaires of EORTC: EORTC-QLQ-C30 for the Change From Baseline at 9 Months of Global Health Status Scores.|"Quality of life evaluation by a standardised questionnaires of European Organisation for Research and Treatment of Cancer (EORTC): EORTC-QLQ-C30 for the change from baseline at 9 months for Global health status scores.~Raw scores are transformed to scales of 0-100. A higher score is associated with a better quality of life for Global health status scores"|Baseline and 9 months.|Treated Set (TS). Number of analysed patients are the total number of patients who were analysed for the change from baseline at 9 months for Global health status scores|||units on scale||Standard Deviation|Mean
1443967|NCT00904839|Secondary|Maximum Plasma Concentration for Nintedanib at Steady State and Normalized by the Dosing Unit Administered (Cmax,ss,Norm) (Phase I)|Maximum plasma concentration for Nintedanib at steady state and normalized by the dosing unit administered (Cmax,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h, and 10h after drug administration.|Treated Set (TS).|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1443968|NCT00904839|Secondary|Area Under the Plasma Concentration Time-curve Over 12 Hours for Nintedanib in the Dosing Interval at Steady State and Normalized by the Dosing Unit Administered (AUCtau,ss,Norm) (Phase I)|Area under the plasma concentration time-curve over 12 hours for Nintedanib in the dosing interval at steady state and normalized by the dosing unit administered (AUCtau,ss,norm) (Phase I)|-0:05h before drug administration and 1h, 2h, 2.5h, 3h, 4h, 6h, 8h and 10h after drug administration.|Treated Set (TS).|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1443969|NCT00904839|Secondary|Maximum Tolerable Dose (MTD)|Determination of Maximum Tolerable Dose based on DLT incidence.|First two treatment cycles, up to 28 days|MTD Set|||mg|||Number
1443984|NCT00904826|Secondary|Number of Subjects With Change in Visual Acuity in at Least One Eye by at Least One Point|Visual acuity was measured using the the Visual Acuity subscale of the Opticospinal Impairment Score (OSIS) for Exacerbations. This subscale ranges from 0 (normal) to 8 (no light perception).|12 months||||participants|||Number
1443970|NCT00904839|Secondary|Percentage of Patients With Dose Limit Toxicity (DLTs) Incidence During the First Two Treatment Cycles (Phase I).|Percentage of patients with DLTs,AE were observed in Gastrointestinal,Hepatobiliary & skin and subcutaneous tissue disorder.Drug related DLT was defined:1)Gastrointestinal toxicity(vomiting, nausea and diarrhoea)or hypertension of CTCAEgrade(G)3 despite optimal supportive care/intervention.2)Non-haematological toxicity of G≥3 except AE:alopecia,nail modifications,& isolated elevation of gamma glutamyl transpeptidase.3)G4 neutropenia for>7days(not associated with fever≥38.5°C).4)Neutropenia of G≥3 of any duration associated with fever≥38.5ºC.5)Platelets <25,000/μLorG3 thrombocytopenia associated with bleeding requiring transfusion.6)Inability to resume nintedanib dosing within14days of stopping due to treatment related toxicity.7)ALT and/or AST elevation of G≥3orG≥2 in conjunction with bilirubin G>1. 8)Inability to recover from increase ALT/AST in conjunction with increase of bilirubin toALT/AST toG≤1 &bilirubin to normal or baseline within14days after nintedanib treatment interruption|First two treatment cycles, up to 28 days|MTD set: The first 12-18 patients randomised to the nintedanib treatment group, treated with nintedanib according to the dose escalation part of the study. The outputs (updated with cleaned and more complete data) that were used to decide on the MTD of nintedanib while the study was ongoing.|||percentage of participants|||Number
1443971|NCT00904839|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|From the first dose of study medication up to 28 days after the day of the last intake of study medication, up to 920 days|Treated Set (TS)|||participants|||Number
1443972|NCT00904839|Secondary|Tumor Shrinkage|"For each patient, the minimum percentage increase from baseline measurement (≤ 28 days before the beginning of the treatment) of the sum Longest diameter (LD) of target lesions was calculated based on the measurements of tumor size. The minimum percentage increase has been divided to four groups:~<= - 30%~> - 30% and < 0%~>= 0% and < 20%~>=20%"|Baseline and day 85|Treated Set (TS)|||participants|||Number
1443973|NCT00904839|Secondary|Resection Rate|"Surgical excision of the lesions is allowed if the previous assessment of tumoral response occurred after at least 6 cycles of treatment. Resection Rate includes resection rates R0, R1 and R2 before progressive disease.~Peto's variance estimate was used."|First treatment administration until end of treatment, up to 892 days|Treated Set (TS)|||percentage of Participants||95% Confidence Interval|Number
1443974|NCT00904839|Secondary|Unconfirmed Objective Response Rate|Objective response is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% Confidence interval represent the Clopper- Pearson exact confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||percentage of Participants||95% Confidence Interval|Number
1443975|NCT00904839|Secondary|Confirmed Objective Response Rate|Objective response rate is defined as a best response of either complete (CR) or partial response (PR) according to RECIST version 1.0. To be assigned a status of PR or CR, changes in tumour measurements had to be confirmed by repetition of the CT or MRI scan no less than 4 weeks after the criteria for response were first met. This confirmation was necessary to avoid overestimating the response rate observed. The 95% confidence interval represent the Clopper-Pearson exact confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||percentage of Participants||95% Confidence Interval|Number
1443976|NCT00904839|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death throughout the whole study. Progression is assessed according to RECIST criteria (version 1.0). In this endpoint, the Greenwood's variance estimate was used to calculate the Kaplan-Meier progression free survival median and its corresponding 95% confidence interval|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||months||95% Confidence Interval|Median
1443977|NCT00904839|Secondary|Overall Survival|Overall survival is defined as the time from first treatment until death. Greenwood variance was used for the calculation of 95% confidence interval.|First treatment administration until end of treatment, up to 892 days|Treated Set (TS).|||months||95% Confidence Interval|Median
1443978|NCT00904839|Primary|Progression-free Survival Rate at 9 Months (PFS-9)|"PFS-9 is defined as the time from first treatment with the trial drug until either the onset of progressive disease or death. A patient is defined as progression-free for 9 months if their PFS was at least 270 days. Progression is assessed according to following mentioned RECIST criteria (version 1.0).~20% increase in the sum of the longest diameter of target lesions.~The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions."|First treatment administration to nine months|Treated Set (TS) - The treated set includes all patients who were dispensed and were documented to have taken at least one dose of the trial drug.|||percentage of Participants||95% Confidence Interval|Number
1443979|NCT00904826|Secondary|Mean Complement Protein 5 (C5) Concentration in CSF||baseline, 3 months|At 3 months, C5 was undetectable in 6 subjects; patient 13 was excluded because she had temporarily discontinued treatment.|||ng/mL||Standard Deviation|Mean
1443980|NCT00904826|Secondary|Mean Eculizumab Concentration in Cerebrospinal Fluid (CSF)||3 months|12 subjects including subject 13 agreed to have CSF draw at the 3 month visit, but subject 13 was excluded because she had temporarily discontinued treatment.|||ng/mL||Standard Deviation|Mean
1443981|NCT00904826|Secondary|Percentage Hemolysis|Percentage of hemolysis is a measure of complement activity. Less than 20% lysis is deemed to be complete complement inhibition.|baseline, 6 weeks, 3 months, 6 months, 9 months, 12 months|Subject 13 was excluded at 3 months visit because she had temporarily discontinued treatment.|||percentage of hemolysis||Standard Deviation|Mean
1443982|NCT00904826|Secondary|Mean Serum Concentration of Eculizumab||6 weeks, 3 months, 6 months, 9 months, 12 months|Patient 13 was excluded from the 3 months measurement because she had temporarily discontinued treatment.|||micrograms/mL||Standard Deviation|Mean
1443983|NCT00904826|Secondary|Number of Subjects With Change in Ambulation by at Least 1 Point|Ambulation was measured by the Hauser Ambulation Index, which ranges from 0 (asymptomatic; fully active) to 9 (restricted to wheelchair; unable to transfer self independently.)|12 months||||participants|||Number
1443988|NCT00904748|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs|Clinically significant abnormalities in blood pressure (BP), pulse, and temperature reported as an adverse event. Clinically significant = values outside the normal range and/or values judged as significant by the investigator (normal range: systolic BP 100-140 mmHg; diastolic BP 60- 90 mmHg; temperature 35-37°Celsius). Pulse rate based on investigator discretion.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.5, 1, 2, 4, 8 and 12 hours post-dose.|Safety population: all subjects who received at least 1 dose of study medication. Although individual listing data for vital signs were collected, summary statistics were not generated for this outcome measure.|||participants|||Number
1443989|NCT00904748|Secondary|Half-life (T 1/2)|Terminal elimination half-life.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||hours||Standard Deviation|Mean
1443990|NCT00904748|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time at which maximum plasma concentration (Cmax) occurred.|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||hours||Standard Deviation|Mean
1443991|NCT00904748|Secondary|Area Under the Curve From 0 to Infinity (AUC 0-inf )|Area under the blood concentration-time profile from time zero extrapolated to infinite time measured in nanograms *hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||ng*hr/mL||Standard Deviation|Mean
1443992|NCT00904748|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma concentration measured in nanograms per milliliter (ng/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||ng/mL||Standard Deviation|Mean
1443993|NCT00904748|Primary|Area Under the Curve (AUC 0-t)|Area under the blood concentration-time profile from time zero to last experimentally determined concentration measured in nanograms*hour/milliliter (ng*hr/mL).|Day 1 (Period 1), Day 8 (Period 2), and Day 15 (Period 3): Pre-dose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, and 12 hours post-dose|Participants for pharmacokinetic analysis = participants who completed all of the 3 treatment periods.|||ng*hr/mL||Standard Deviation|Mean
1443994|NCT00904722|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was measured from enrollment to disease progression or recurrence or death from any cause.|Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.|||months||95% Confidence Interval|Median
1443995|NCT00904722|Primary|Overall Response Rate|Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.|Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.|One patient was withdrawn after one infusion of CT-011 as per the treating physician's decision.|||participants|||Number
1443996|NCT00904670|Other Pre-specified|SKAMP Compliance Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1443997|NCT00904670|Other Pre-specified|SKAMP Quality of Work Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1444032|NCT00904371|Primary|Change From Baseline in Framingham CVD Risk Assessment Score|10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||units on a scale||Standard Deviation|Mean
1443998|NCT00904670|Secondary|SKAMP Combined Scores Over 12 Hours|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Data for combined SKAMP score was collected and reported through the measure of onset and duration of clinical effects as given in outcome measure 2.||||||
1443999|NCT00904670|Secondary|Permanent Product Measure of Performance (PERMP) Score Over 12 Hours|The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant’s performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1444000|NCT00904670|Secondary|SKAMP Deportment Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1444001|NCT00904670|Secondary|SKAMP Attention Subscale Score Over 12 Hours|SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1444002|NCT00904670|Secondary|Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale|Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 8, 10, 12 hours post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1444003|NCT00904670|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose|The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant’s impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.|Hour 4 post-dose|Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1444004|NCT00904618|Secondary|Safety of the Sling.|Safety of the sling was assessed with a record of perioperative and postoperative complications. The following are all the complications experienced with the TVT-SECUR for each technique, the 'Hammock' technique and the 'U-Method'.|15 months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the ‘U-Method’.|||Participants|||Number
1444033|NCT00904371|Primary|Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)|A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||units on a scale||Standard Deviation|Mean
1444005|NCT00904618|Secondary|Improvement in Stress Urinary Symptoms.|A questionnaire with a Likert scale from one to five was used to assess the improvement in stress urinary symptoms at six months for each technique, the 'Hammock' technique and the 'U-Method' (1-Worst, 2-Same, 3-Improved, 4-Almost cured, 5-Cured). Patients had to answer 3 or more on the scale to be considered improved.|Six months|The ‘Hammock’ technique, similar to the transobturator tape dissection, was used in the first 23 cases and the ‘U-Method’, similar to the retropubic tape dissection, in the last 25 cases. Seven patients for the 'Hammock' technique and three patients for the 'U-Method' did not fill out the questionnaire at six months.|||participants|||Number
1444006|NCT00904618|Primary|Local Anesthesia Satisfaction|Local anesthesia satisfaction was assessed with a questionnaire completed by the patients. The patients were asked if they would recommend this type of anesthesia (yes or no).|Questionnaire filled 1 week after surgery|2 patients did not fill out the questionnaire 1 week after surgery|||participants|||Number
1444007|NCT00904488|Secondary|Blood Urea Nitrogen (BUN)||Baseline, 24, 48, 72, 96 hours||||mg/dL||Standard Deviation|Mean
1444008|NCT00904488|Secondary|Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic||30 days|30-day follow up data (except for mortality) were not collected in 2 participants|||Participants|||Count of Participants
1444009|NCT00904488|Secondary|Rehospitalization at 30 Days||30 days|30-day follow up data (except for mortality) were not collected in 2 participants|||Participants|||Count of Participants
1444010|NCT00904488|Secondary|30-day All-cause Mortality||30 days||||Participants|||Count of Participants
1444011|NCT00904488|Secondary|Length of Hospitalization||Assessed till hospital discharge, an average of 1 week (longest 29 days)|Data not available in all subjects.|||Days||Standard Deviation|Mean
1444012|NCT00904488|Secondary|Time to Return to Baseline Weight||0-96 hours|Weight was not collected in all subjects every day.|||Days||Standard Deviation|Mean
1444013|NCT00904488|Secondary|Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure)|Patients will be considered a treatment failure if they require additional diuretic (including crossover to the alternative study arm) or require IV vasoactive drug therapy (e.g. vasodilators including nitroglycerin or inotropes) as deemed appropriate/necessary by their medical team.|0-96 hours||||Participants|||Count of Participants
1444014|NCT00904488|Secondary|Physician Global Assessment Scale|"Scale range: 1-5 Which of the following best describes the patient’s overall health state today?~= markedly worse~= worse~= neither better nor worse~= better~= markedly better"|Baseline, 24, 48, 72, 96 hours|Data were not collected at all time points, and were only analyzed when available.|||units on a scale||Standard Deviation|Mean
1444015|NCT00904488|Secondary|Patient Global Assessment Scale|"Scale range: 1-5 Which of the following best describes your overall health state today?~= markedly worse~= worse~= neither better nor worse~= better~= markedly better"|Baseline, 24, 48, 72, 96 hrs|Data were not collected at all time points, and were only analyzed when available.|||units on a scale||Standard Deviation|Mean
1444016|NCT00904488|Secondary|Daily Weight||Baseline (Dry), Baseline, 0-24, 24-48, 48-72, 72-96 hrs|Data were not collected for all subjects at all time points, and were only analyzed when available|||Kg||Standard Deviation|Mean
1444017|NCT00904488|Secondary|Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)||0-24, 24-48, 48-72, 72-96 hrs|Data were not collected at all time points for all subjects, and were only analyzed when available. Data not analyzed on days when diuretics were held or discontinued.|||ml/mg furosemide received||Standard Deviation|Mean
1444018|NCT00904488|Secondary|Daily Net Fluid Output on Days 1, 3, and 4|Daily net fluid output = daily fluid output - daily intake. A negative value means that daily fluid intake was less than the daily fluid output.|0-24, 48-72, 72-96 hrs|If diuretic therapy is changed to the oral route before a scheduled efficacy endpoint is to be measured (e.g.72 or 96 hour net output), then that endpoint will not be obtained.|||ml/day||Standard Deviation|Mean
1444019|NCT00904488|Primary|Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization)|Net fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output.|24-48 hours||||mL/day||Standard Deviation|Mean
1444020|NCT00904423|Secondary|Serum Calcium and Fasting Spot Urine Calcium/Creatinine Ratio||every 4 months|Data are not accessible.||||||
1444021|NCT00904423|Secondary|Arthralgias and Myalgias||every 4 months|Data are not accessible.||||||
1444022|NCT00904423|Secondary|Bone Turnover Markers||months 4 and 12|Data are not accessible.||||||
1444023|NCT00904423|Secondary|Change in Hip Bone Mineral Density (BMD) T-score||one year|Data are not accessible.||||||
1444024|NCT00904423|Primary|Spine Bone Mineral Density T Score Change Over One Year||1 year|Data are not accessible.||||||
1444025|NCT00904371|Secondary|Number of Participants Not Completing Study|Number of participants discontinuing study early for given reason|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)|||Participants|||Number
1444026|NCT00904371|Secondary|Number of Patients With Adverse Events (AE)||4-10 months|Treated patients|||Participants|||Number
1444027|NCT00904371|Secondary|Change in Heart Rate From Baseline to Study End||Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status|||Beats per minute||Standard Deviation|Mean
1444028|NCT00904371|Secondary|Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)|Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)|||Percentage of participants|||Number
1444029|NCT00904371|Secondary|Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC|ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients|3rd visit (4-10 months)|Patients with data at 3rd visit (4-10 months)|||Percentage of participants|||Number
1444030|NCT00904371|Primary|Change From Baseline in Risk Assessment According to ESH/ESC Guidelines|ESH is the European society of hypertension, and ESC is the European society of cardiology.|Baseline to 3rd visit (4-10 months)|Patients with data both at baseline and on 3rd visit (4-10 months)|||Participants moved into category|||Number
1444040|NCT00904189|Secondary|Determination of the Range of Background Signal Measured by the EPR Device.||2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.||||||
1444041|NCT00904189|Primary|Mean Dose of Radiation Received by Fingernails|The mean dose in gray of radiation exposure to participants fingernails as determined by Electron Paramagnetic Resonance (EPR).|2.5 years|The study enrolled only 2 subjects and then was substantially changed. After the amendment, no further subjects were enrolled. The data collected from the two enrolled subjects was not analyzed and therefore is not available.||||||
1444042|NCT00904150|Secondary|Menstrual Cycle Expression of TNF and SYNE1 in Women With Menstrual Migraine and Women Without Migraine|TNF and SYNE1|6 years|Matched luteal and follicular phase samples Not all samples were suitable for analysis for each outcome measure|||number of genes expressed||Standard Deviation|Mean
1444043|NCT00904150|Primary|Menstrual Cycle Expression of PGR and ESR in Women With Menstrual Migraine and Women Without Migraine|PgR and ESR|6 years|Matched pairs of follicular and luteal samples Not all samples were suitable for analysis for each outcome measure|||number of genes expressed||Standard Deviation|Mean
1444044|NCT00904150|Primary|Estrogen Receptor 1 C325G Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 C325G|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
1444045|NCT00904150|Secondary|SYNE1 Genotype in Women With Menstrual Migraine and Women Without Migraine|SYNE1|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
1444046|NCT00904150|Secondary|Tumour Necrosis Factor Genotype in Women With Menstrual Migraine and Women Without Migraine|TNF|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
1444047|NCT00904150|Primary|Estrogen Receptor 1 G594a Polymorphism in Women With Menstrual Migraine and Women Without Migraine|ESR1 G594A|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
1444048|NCT00904150|Primary|Progesterone Receptor Gene Polymorphism PROGINS in Women With Menstrual Migraine and Women Without Migraine|PR PROGINS|6 years|Not all samples were suitable for analysis for each outcome measure|||participants|||Number
1444049|NCT00904007|Secondary|Provider-perceived Barriers and Facilitators to the Spaced Education Intervention||Months 1-12|||||||
1444050|NCT00904007|Secondary|Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention||Months 1-12|||||||
1444051|NCT00904007|Secondary|Provider-perceived Effectiveness of Spaced Education Intervention||Months 1-12|||||||
1444052|NCT00904007|Secondary|Provider-perceived Acceptability of Spaced Education Intervention||Months 1-12|||||||
1444053|NCT00904007|Secondary|Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only)||Months 1-12|||||||
1444054|NCT00904007|Secondary|Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)||Months 1-12|||||||
1444055|NCT00904007|Secondary|Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)||Months 1-12|||||||
1444056|NCT00904007|Secondary|Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)||Month 1|||||||
1444057|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure||Months 1-24|||||||
1444058|NCT00904007|Secondary|Cross-cohort Comparison of Frequency of Treatment Intensification||Months 1-24|||||||
1444059|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24)||Months 1-24|||||||
1444060|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24)||Months 1-24|||||||
1444061|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24)||Months 13-24|||||||
1444062|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24)||Months 13-24|||||||
1444063|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12)||Months 1-12|||||||
1444064|NCT00904007|Secondary|Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12)||Months 1-12|||||||
1444065|NCT00904007|Primary|Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure|A unique hypertensive period served as the unit of analysis. A hypertensive period started on the first day during the study when a patient’s BP was elevated. It ended on the first subsequent day when it was <140/90 mm Hg or on the last day BP was recorded during the study. Duration of the hypertensive period (days) was the outcome measure. BP measurements obtained in the course of routine care were used to ascertain study outcomes, whether obtained by the PCP or at other clinic visits. These measurements were obtained from structured data (ie, BP recordings in the electronic medical record) and natural language processing of provider notes as previously described. If several measurements were recorded on the same day, the lowest mean arterial BP was used.|Months 1-24||||days||Full Range|Median
1444066|NCT00903968|Secondary|Duration of Response (DOR) [Phase II]|DOR is defined as the time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died. DOR was estimated using the Kaplan-Meier method.|DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.|All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for DOR.|||Months||95% Confidence Interval|Median
1444223|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months||||Log (pg/ml)||Standard Deviation|Mean
1444067|NCT00903968|Secondary|Time to Progression (TTP) [Phase II]|TTP estimated using the Kaplan-Meier method is defined as the time from registration to progression based on IMWG criteria or date last known progression-free for those who have not progressed. [Durie BG et al. Leukemia. 2006] Progression (PD): ≥ 25% increase from lowest value reported in serum M-component (absolute increase ≥0.5 g/dL) and/or urine M-component (absolute increase ≥200 mg/24 hours); if appropriate, a ≥25% increase above the lowest level in the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); If none of these are measurable then ≥25% increase in bone marrow plasma cell percentage above the lowest response level (absolute ≥10%); Definite development of new bone lesions or soft tissue plasmacytomas OR increase in size of existing|DIsease was assessed to document progression every cycle on treatment and post-treatment every 12 weeks until progression.|All Phase II participants with measureable disease present at baseline and received at least one dose of the study drug were evaluable for TTP.|||Months||95% Confidence Interval|Median
1444068|NCT00903968|Primary|Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]|Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR) which is a complete disappearance of monoclonal paraprotein based on negative immunofixation on the serum M-component and urine M-component and no evidence of myeloma in bone marrow, Very Good Partial Response (VGPR) defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component <100 mg per 24 hours, Partial Response (PR) ≥50% reduction in serum M-component or ≥90% reduction urine M-component or urine M-component <200 mg per 24 hours, Minimal Response (MR) ≥25% reduction in serum or urine M-component, Stable Disease (SD) defined as failure to meet any response criteria, and Progressive Disease (PD) ≥ 25% increase from lowest value reported in serum M-component (absolute ≥0.5 g/dL) and/or urine M-component (absolute ≥200 mg/24 hours).|Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.|All participants with measureable disease at baseline and received at least one dose of the study drug were evaluable for response.|||Participants|||Count of Participants
1444069|NCT00903968|Primary|Number of Participants With Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as (a) grade 3 or greater non-hematologic toxicity, considered by the investigator to be related to plerixafor or bortezomib, with the exception of nausea, vomiting or diarrhea unless receiving maximal medical therapy, (b) grade 4 hematologic toxicity defined as: thrombocytopenia with platelets <10,000 on more than one occasion within first cycle despite transfusion. Grade 4 neutropenia must occur for more than 5 days and/or result in neutropenic fever with elevated temperature (defined as > 101 degrees F). (c) inability to receive Day 1 dose for Cycle 2 due to toxicity. All adverse events were graded according to the CTEP Common Toxicity Criteria (CTCAE v.3.0).|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for DLT.|||Participants|||Count of Participants
1444070|NCT00903968|Primary|Bortezomib Maximum Tolerated Dose (MTD) [Phase I]|The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of bortezomib was given on days 3, 6, 10, 13 of 21 each cycle.|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for MTD.|||mg/m2|||Number
1444071|NCT00903968|Primary|Plerixafor Maximum Tolerated Dose (MTD) [Phase I]|The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of plerixafor was given on days 1, 2, 3, 6, 10, 13 of 21 each cycle.|Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.|All Phase I participants who received at least one dose of the study drug were evaluable for MTD.|||ug/kg|||Number
1444072|NCT00903929|Secondary|Median Number of Platelet Transfusions up to the Day of Engraftment||baseline to day of engraftment||||units of platelets||Full Range|Median
1444073|NCT00903929|Secondary|Median Time to Platelet Engraftment|Determined for all participants who completed at least 75% of the planned doses. Platelet engraftment was as defined by the Center for International Blood and Marrow Transplant Research as the first of 3 consecutive days of a platelet count 20,000/mL without platelet trans-fusions for 7 days and/or the first day of a platelet count 100,000/mL without platelet transfusions for 7 days.|1.5 years||||days||Full Range|Median
1444074|NCT00903929|Primary|Maximum Tolerated Dose (MTD) of Eltrombopag|The MTD was defined as the highest dose if no dose limiting toxicity was observed, or the highest dose at which less than one-third of the patients experienced toxicities not expected in the standard stem cell transplantation setting.|1.5 years||||mg/day|||Number
1444075|NCT00903877|Primary|Visual Analogue Scale of Pain Intensity|Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).|12 weeks||||Units on a scale||Standard Deviation|Mean
1444076|NCT00903786|Secondary|The Clinical Global Impression of Change (CGIC) at Week 52 and End of Treatment|The investigator evaluated each participant for CGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing medical conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.|Week 52 and End of Treatment, up to approximately 7 years 2 months|Efficacy Analysis Population|||Percentage of participants|||Number
1444224|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Baseline|Simple correlations will be computed at Baseline for quality of life scores.|Baseline||||correlation coefficient|||Number
1444077|NCT00903786|Secondary|The Patient Global Impression of Change (PGIC) at Week 52 and End of Treatment|Each participant evaluated him/herself for PGIC at Week 52 of the Treatment Period and at the end of treatment (or discontinuation) by comparing seizure conditions during 4 weeks before Week 52 of the Treatment Period and those during 4 weeks before end of treatment (or discontinuation) of the open label extension study with those during 4 weeks before start of the Treatment Period of Study 231. Assessment was implemented based on frequency of seizure, severity of seizures, AEs, and overall conditions using the 7-grade scores. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse.|Week 52 and End of Treatment; up to approximately 7 years 2 months|Efficacy Analysis Population|||Percentage of participants|||Number
1444078|NCT00903786|Secondary|Responder Rate During the Treatment Period-LOCF|"Responder rate (percentage of participants with greater than or equal to 50% reduction in seizure frequency for 28 days in the Treatment Period relative to that for 28 days in the observation period of Study 231 [responder]. If the reduction in seizure frequency is less than 50%, then the participants are considered as non-responders.~LOCF = Last Observation Carried Forward."|Week 1 through Week 316 and Follow-up period of the Extension study, up to approximately 7 years 2 months|Efficacy Analysis Population|||Percentage of participants|||Number
1444079|NCT00903786|Secondary|Percent Change in Total Seizure Frequency Per 28 Days for the Treatment Period Summarized Until Week 316|Seizure frequency was derived from information (seizure count and type) recorded in the participant diary. The seizure frequency per 28 days was calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. Of the 21 participants, 20 participants concomitantly used at least 1 inducer anti-epileptic drug (AED) (carbamazepine, phenytoin, phenobarbital, or primidone), and 1 participant used only non-inducer AEDs. The data is presented as median percent change with full range.|From Week 1 through Week 316 and Follow-up Period of the Extension Study, up to approximately 7 years 2 months|"The Efficacy Analysis Population (identical to the SAS for this study) was defined as all participants who met the inclusion/exclusion criteria regarding indication (inclusion criteria number 5 of Study 231), who received at least one dose of study treatment, and who had at least one data on efficacy."|||Percent change in seizure frequency||Full Range|Median
1444080|NCT00903786|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|Safety was assessed by monitoring adverse events (AEs), adverse drug reactions, clinical laboratory parameters, vital signs, 12-lead electrocardiogram, and dependency questionnaire. AEs were graded on a 3-point scale; 1) mild: (Grade 1) discomfort noticed, but no disruption of normal daily activity, 2) moderate: (Grade 2) discomfort reduced or affected normal daily activity, and 3) severe: (Grade 3) incapacitating, with inability to work or to perform normal daily activity. AE severity associated with abnormal changes in laboratory parameters was assessed using the Ministry of Health and Welfare Notification Number 80 “Classification of Severity of Adverse Drug Reactions of Medicinal Products”. TEAEs were defined as AEs that emerged during treatment (absent at pretreatment [Baseline]), reemerged during treatment (were present at pretreatment but stopped before treatment), or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 7 years 2 months|"The Safety Analysis Set (SAS) was defined as all participants who met the inclusion/exclusion criteria regarding indication (inclusion criteria number 5 of Study 231), who received at least one dose of study treatment, and who had at least one evaluable set of safety data."|||Participants|||Number
1444081|NCT00903695|Primary|Differences in Instrumental Activities of Daily Living (IADL) Scores Over 12 Months, by Study Group|IADL is a behavior rating scale using 9 domains of household and community activities, with a total score of 27 points indicating less competence than a normal function score of 9 points. Outcome measure is results of an ANOVA of the differences between baseline and end/last score, by study arm/group, to detect statistically significant differences (nutriceutical vs placebo).|baseline to 12 months|All subjects who completed 12-month study were included.|||units on a scale||Standard Error|Mean
1444082|NCT00903695|Primary|Differences in Activities of Daily Living (ADL) Scores Over 12 Months, by Study Group|ADL is a behavior rating scale with 6 domains of self-care (feeding, toileting, etc.) in which a maximum score of 18 indicates less competence than a minimum score of 6 (normal skills). Outcome measure is results of ANOVA of the differences between baseline and last/end scores, by study arm/group, to detect any statistically significant differences.|baseline to 12 months|All subjects who completed 12-month study were included.|||units on a scale||Standard Error|Mean
1444083|NCT00903695|Primary|Differences in Neuropsychiatric Inventory (NPI) Scores Over 12 Months, by Study Group|NPI is a behavior rating scale with 12 categories in which a maximum score of 36 points indicates more pathology than a minimum score of 0. Outcome measure reported here is results of an ANOVA of the differences between baseline and end scores, by study arm/group, to detect any statistically significant difference (nutriceutical vs placebo groups) was completed.|baseline to 12 months|All subjects who completed 12-month study were included.|||units on a scale||Standard Error|Mean
1444084|NCT00903695|Primary|Differences in MiniMental State Exam (MMSE) Scores Over 12 Months, by Study Group|MiniMental State Exam is a cognitive screening device with possible 30 points in several categories; higher points indicate greater competence. Clinician tests orientation, attention, language, & visuo-spatial construction. Outcome measure is results of an ANOVA of differences between baseline and end/last scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.|||units on a scale||Standard Error|Mean
1444085|NCT00903695|Primary|Differences in Clock Drawing Test (CLOX) Scores Over 12 Months, by Study Group|Clock Drawing Test is a cognitive screening instrument in which subjects are to draw a clock and set a specified time. Various scoring methods can be employed using 4 to 15 points, with more points showing more competence. This study used the 8-point scoring method, so that 0-8 points could be assigned during each of the baseline and 4 assessment periods during the 12-month study. ANOVA of the differences between baseline and end scores, by study arm/group was completed.|baseline to 12 months|All subjects who completed the 12-month study were included.|||units on a scale||Standard Error|Mean
1444086|NCT00903695|Primary|Differences in Clinical Dementia Rating Scale (CDR) Over 12 Months, by Study Group|CDR is a rating scale for 8 aspects of behavior with 0-3 points allowed; higher scores indicate more pathology. Total minimum and maximum scores are 0 and 36 respectively.Clinician rates the patient's behavior and competence with input from family members who live with the patient. ANOVA of differences between baseline and end scores of the CDR scale are reported here, by the study arm/group.|baseline before intervention to 12 months of intervention|All subjects who completed the 12-month study were included (placebo and nutriceutical arms/groups).|||units on a scale||Standard Error|Mean
1444087|NCT00903695|Primary|Differences in Dementia Rating Scale (DRS) at 12 Months From Baseline, by Study Group|Dementia Rating Scale (DRS) is a cognitive test with 5 domains; raw scores can be converted to percentiles for age/education levels, so individuals can be compared. Higher scores mean more competence (0-36 points converted to percentiles so different ages can be compared). Total raw scores for the 5 domains were computed so that Mean and SD of differences between first and last assessments for all subjects, by study arms (nutriceutical = XL and placebo = PL) are reported here.|Baseline and 12 months|All participants who completed 12-month study were included in the ANOVA analysis of the differences in scores of tests between baseline and end assessments.|||units on a scale||Standard Deviation|Mean
1444088|NCT00903695|Secondary|Number of Subjects Who Converted to Early Alzheimer's (Dementia).|Neurological diagnosis is based on test scores that reach -1.6 SD of mean for age/education, and on radiological tests of brain structure (CT, MRI, PET). Usual cutoff for test score percentile is <0.05 to diagnose dementia.|12 months|Subjects diagnosed as Mild Cognitive Impairment (MCI) in VA clinic were given opportunity to participate in the study if they met inclusion/exclusion criteria (no illnesses that cause brain damage or are uncontrolled such as brittle diabetes).|||participants|||Number
1444089|NCT00903682|Secondary|Resistance Determinations|The evolution of viral genotype and phenotype was assessed by the number of patients with resistance-associated mutations emerging at the endpoint. A mutation was considered emerging if it was present at endpoint and not present at baseline or any pre-baseline assessment. (NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; RAM = resistance-associated mutation, IAS-USA = International AIDS Society - USA)|at baseline and all subsequent visits until week 48 in case if virologic failure|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol|||number of participants|||Number
1444090|NCT00903682|Secondary|Mean Change From Baseline in CD4+ Cell Count|The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.|at baseline and week 2, 6, 12, 24, 36 and 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol|||number of cells/L (x10^6)||Standard Error|Mean
1444091|NCT00903682|Secondary|Neuropsychiatric Adverse Events by Week 48|The percentage of patients with at least 1 treatment emergent Grade 1 -4 neurologic or psychiatric adverse event, judged by the investigator to be at least possibly related to the study drug.|from baseline to week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||percentage of patients|||Number
1444092|NCT00903682|Secondary|Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score|"The HIV Patient Symptoms Profile measures the tolerability of HIV treatment from the patient's perspective, using 14 concept scales in maximum 84 questions. The response options include a no or yes answer to Did symptom occur?. If yes, there is a problem scale which ranges from 1 = I had this symptom and it was not a problem to 5 = I had this symptom and it was a severe problem. A neuropsychiatric tolerability score is composed as the sum of 21 items and ranges from 0 (best) to 105 (worse). A total Tolerability score (ie, the sum of all items) ranges from 0 (best) to 420 (worse)"|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||points on a scale||Standard Error|Mean
1444093|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <200 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||Number of participants|||Number
1444094|NCT00903682|Secondary|Antiviral Activity of ETR vs. EFV|The proportion of patients with confirmed plasma viral load <50 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)|between baseline and week 48|ITT: the set of all randomized patients who have taken at least 1 dose of trial medication, regardless of their compliance with the protocol.|||Number of participants|||Number
1444095|NCT00903682|Primary|Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event|Proportion of patients with at least 1 treatment-emergent Grade 1-4 Central Nervous System or psychiatric Adverse Event, observed between Baseline through Week 12 and judged by investigator to be at least possibly related to the study drug in ETR group versus EFV group. All Adverse Events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (“DAIDS AE grading table”). Grade 1-4 covers all severities.|between baseline and 12 weeks|The intent-to-treat (ITT) population has been defined as the set of all patients who were randomized and who have taken at least one dose of trial medication, regardless of their compliance with the protocol.|||percentage of patients|||Number
1444096|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:~At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurement, or the appearance of one or more new lesion(s)."|6 months after starting treatment||||participants|||Number
1444097|NCT00903630|Secondary|Phase 2 - Number of Subjects Who Are Progression-Free and Alive|"Progression is defined as:~At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."|3 months after starting treatment||||participants|||Number
1445145|NCT00891774|Primary|Safety Endpoint|Safety Endpoint includes three categories: 1) composite determination of success (no pigmentation change or keloid formation); 2) pigmentation changes; and 3) keloid formation|6 months post injection||||Participants|||Number
1444098|NCT00903630|Primary|Phase 2 - Number of Subjects Achieving a Partial or Complete Response|"Partial response is defined as:~At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.~Complete response is defined as:~The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met."|3 months after starting treatment||||participants|||Number
1444099|NCT00903630|Primary|Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.|within 5 weeks of starting treatment||||participants|||Number
1444100|NCT00903630|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer|The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).|1 cycle (28 days)||||milligrams (mg)|||Number
1444101|NCT00903617|Secondary|Plasma PK- AUC(0-t)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine AUC(0-t) was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Analysis Population. Only those participants available at the indicated time points were analyzed.|||Hour nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1444102|NCT00903617|Secondary|Plasma PK- Time of Occurrence of Cmax (Tmax)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Tmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The time at which Cmax was observed was determined directly from the raw concentration-time data.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Population.|||Hours||Full Range|Median
1444103|NCT00903617|Secondary|Plasma PK- Maximum Observed Concentration (Cmax)|All participants treated with GSK256073 or placebo participated in PK sampling. Blood samples for PK analysis of GSK256073 to determine Cmax was collected at Week 2, 4, 6 and 8. For samples obtained during time windows, every attempt was made to collect three samples during each time window: pre-dose to 2 hours after dosing, 2 hours to 4.5 hours after dose, and 6 hours to 12 hours after dose. During each window, 3 samples spaced at least 30 minutes apart were collected (i.e., avoid collection from all participants at the same time within a window or only at the extremes of a time window). The first occurrence of the Cmax was determined directly from the raw concentration-time data.|0-2 hours after dosing (pre-dose plus 3 samples spaced at least 30 minutes apart), 2 to 4.5 hours after dose (3 samples spaced at least 30 minutes apart) and 6-12 hours post dose (3 samples spaced at least 30 minutes apart) on Week 2, 4, 6 and 8|PK Population was defined as all participants in the PK concentration population for whom PK parameters had been derived.|||Nanograms per mililiter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1444104|NCT00903617|Secondary|Percent Change From Baseline in Non-esterified Fatty Acids (NEFA) Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of NEFA was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1444105|NCT00903617|Secondary|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of Lp[a] was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1444106|NCT00903617|Secondary|Percent Change From Baseline in Insulin Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of insulin was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from Baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1444118|NCT00903617|Secondary|Number of Participants With Abnormal Hematology Values|Blood samples for assessment of hematology parameters of platelet count, red blood cell count, white blood cell count, hemoglobin, haptoglobin, reticulocyte count, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils and basophils was collected at Baseline and at Weeks 2, 4, 6 and 8.|Baseline (Week 0) up to Week 8|Safety Population.|||Participants|||Count of Participants
1444107|NCT00903617|Secondary|Percent Change From Baseline in Fasting Levels of Total Cholesterol (TC), Triglyceride (TG), Glucose, Low Density Lipoprotein Cholesterol (LDLc), Apolipoprotein A2 (ApoAII), Apolipoprotein B (ApoB) Over 8 Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of fasting levels of TC, TG, glucose, LDLc, ApoAII and ApoB was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1444108|NCT00903617|Secondary|Percent Change From Baseline in Fasting Plasma HDLc and Apolipoprotein A-I (ApoA1) Concentrations Over Eight Weeks of Administration With GSK256073 or Placebo|Blood samples for analysis of fasting levels of HDLc and ApoA1 was collected at Baseline (Week 0) and Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value. Percent change from Baseline was calculated by multiplying change from baseline value with 100.|Baseline (Week 0) up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1444109|NCT00903617|Secondary|Mean Episode of Flushing as Measured by Visual Analogue Scale (VAS)|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants self-assessed intensity of flushing using a 100 mm VAS once daily at the first flushing episode. The left hand side of the scale (0) represented ‘No Flushing Sensation’ and the right hand side of the scale (100) represented ‘Unbearable Flushing Sensation’. The intensity of flushing of each episode was measured in centimeters (to the nearest 1/100) from the 0 point of the scale. Data is reported for average VAS scores over 8 weeks of treatment.|Up to Week 8|PD Population was defined as all participants who provided PD data.|||Scores on a scale||Standard Deviation|Mean
1444110|NCT00903617|Secondary|Number of Participants Who Withdrew Due to Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits.|Up to follow up (14 days from last dose)|Safety Population.|||Participants|||Count of Participants
1444111|NCT00903617|Secondary|Participant's Average Duration of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participant’s average duration of flushing was analyzed.|Up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Minutes||Full Range|Median
1444112|NCT00903617|Secondary|Average Time to Onset of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. The time to the onset of the first flushing (if more than one happens to occur on each day) was analyzed.|Up to Week 8|PD Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
1444113|NCT00903617|Secondary|Average Number of Flushing Episodes|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants with average number of flushing episodes was reported as “did not have flushing episode”, “1 flushing episode”, “2 flushing episode” and “3 or more flushing episode”.|Up to Week 8|PD Population.|||Participants|||Count of Participants
1444114|NCT00903617|Secondary|Number of Participants With Self Reported Assessment of Flushing|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Participants were asked to perform an assessment of their perceived flushing intensity after their completion of VAS assessment once daily after their first flushing episode (if more than one happens to occur). The scale was from 0 to 3, where 0 represents no flushing, 1 represents mild flushing, 2 represents moderate flushing, and 3 represents severe flushing.|Up to Week 8|PD Population.|||Participants|||Count of Participants
1444115|NCT00903617|Secondary|Average Global Flushing Score|Flushing assessment was captured by participants in individual diaries provided to each study participant. Participants were instructed to return their diaries after each study visit (Week 2, Week 4, Week 6 and Week 8) where they were given a new diary for the time between visits. Flushing symptom questionnaire (FSQ) was used to measure participant reported feelings of severity associated with different types of flushing symptoms. The FSQ comprised of 11 items. The response scale combined verbal descriptors as well as a 0-10 numerical rating scale. Items 1, 2, 4 and 10 had verbal descriptors. The items 3, 5, 6, 7, 8, 9 and 11 were rated on a 0 to 10 scale (none=0, mild=1–3, moderate=4–6, severe=7–9 and extreme=10). The total score for these items ranged from 0 (not at all) to 70 (extreme). Higher score indicated more severe flushing symptoms and 0 indicated no flushing symptoms.|Up to Week 8|PD Population.|||Participants|||Count of Participants
1444116|NCT00903617|Secondary|Number of Participants With Abnormal Urinalysis Results|Urinalysis assessment was done for urine occult blood, urine glucose, urine ketones and urine protein over eight weeks treatment period.|Up to Week 8|Safety Population.|||Participants|||Count of Participants
1444117|NCT00903617|Secondary|Number of Participants With Abnormal Clinical Chemistry Values|Blood samples for assessment of clinical chemistry parameters of blood urea nitrogen, creatinine, glucose (fasting), sodium, creatine phosphokinase, potassium, chloride, total carbon dioxide, calcium, total lactose dehydrogenase (LDH), aspartate aminotransferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, phosphate, total and direct bilirubin, uric acid, albumin and total protein was collected at Baseline and at Weeks 2, 4, 6 and 8.|Up to Week 8|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1444119|NCT00903617|Secondary|Change From Baseline in Vital Signs-Heart Rate|Heart rate was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.|Baseline (Week 0) up to Week 8|Safety Population. Only those participants available at the indicated time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1444120|NCT00903617|Secondary|Change From Baseline in Vital Signs-Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP was assessed at Baseline (Week 0), Week 2, 4, 6 and 8. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the post-Baseline value from the Baseline value.|Baseline (Week 0) up to Week 8|Safety population. Only those participants available at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1444121|NCT00903617|Secondary|Number of Participants With Electrocardiography (ECG) Findings|Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. Participants with normal, abnormal- clinically significant (CS) and abnormal- not clinically significant (NCS) ECG values were reported.|Up to Week 8|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1444122|NCT00903617|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, medically significant or it is associated with liver injury and impaired liver function.|Up to follow up (14 days from last dose)|Safety Population was defined as all participants who received at least one dose of study drug.|||Participants|||Count of Participants
1444123|NCT00903617|Primary|The GSK256073 Area Under Concentration-time Curve (AUC) and High Density Lipoprotein Cholesterol (HDLc) Data to Evolve the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship for Changes in HDLc Levels|The potential PK/PD relationship was to be assessed by plotting GSK256073 AUCs against HDLc. The PK/PD model that was to be used for the simulations in the study design was to be refined with the Part A observed AUC exposures and HDLc levels. However, the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.|Week 2, 4, 6 and 8|Data was not collected as the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.||||||
1444124|NCT00903448|Primary|Mean Percent Time That Gastric pH > 4.0 on Day 5|for 24 hours starting Day 5 for each period|24 hours|This study was a three period, crossover study of 40 subjects entering either treatment sequence ABB or BAA; consequently each subject in the study participated in three periods over which each subject would eventually receive both Prilosec OTC and Prevacid|||percent time gastric pH exceeds 4.0||Standard Error|Mean
1444125|NCT00903409|Secondary|Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial|Median percent change from LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial|ITT Population|||Percentage change||Full Range|Median
1444126|NCT00903409|Secondary|Median Percent Change of Lipid Measurements From LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in “Switchers” vs. Non-switchers|Median percent change from LOV111858 Baseline to LOV111818 Months 4, 12, and 24 visits of the open-label extension trial|Months 4, 12, and 24 (LOV111818) of the open-label extension trial|ITT Population|||Percent change||Full Range|Median
1444127|NCT00903409|Primary|Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers Subjects From LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)|Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)|Month 4 (LOV111818)|Intent-to-Treat (ITT) Population: Comprised of data for all participants who were enrolled and received at least one dose of study medication|||Percent change||Full Range|Median
1444128|NCT00903396|Secondary|Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1444129|NCT00903396|Secondary|Tolerability and Adverse Events as Assessed by NCI CTC v 3.0||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1444130|NCT00903396|Secondary|Proportion of Patients Reporting Treatment Failure||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1444131|NCT00903396|Secondary|Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1444132|NCT00903396|Primary|Complete Response (no Episodes of Nausea or Vomiting)||Up to 2 years|Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.||||||
1444133|NCT00903383|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12|The value for Erythrocyte Sedimentation Rate (mm) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population|||mm||Standard Deviation|Mean
1444134|NCT00903383|Secondary|Change From Baseline in C-reactive Protein (mg/L) at Week 12|The C-reactive protein value (mg/L) at baseline was subtracted from the value for each of the treatment groups at Week 12.|Baseline and 12 weeks|Intent to Treat Population|||mg/L||Standard Deviation|Mean
1444498|NCT00897390|Primary|Saxagliptin PK Parameter Maximum Observed Plasma Concentration (Cmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng/mL||Full Range|Geometric Mean
1444135|NCT00903383|Secondary|Hybrid ACR Response at Week 12|Evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a continuous score of the mean change in core set measures. The percentage improvement from baseline was computed in each of the components of the ACR. The average percent improvement was calculated and used with the subject's ACR20, ACR50, and ACR70 status to compute the hybrid ACR response, with a positive change indicating improvement.|Baseline and 12 weeks|Intent to Treat Population|||Percent change||Standard Deviation|Mean
1444136|NCT00903383|Secondary|ACR70 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 70% response criteria (ACR70) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR70, there had to be ≥70% improvement in swollen joint count, ≥70% improvement in painful/tender joint count, and ≥70% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population|||Participants|||Number
1444137|NCT00903383|Secondary|ACR50 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 50% response criteria (ACR50) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR50, there had to be ≥50% improvement in swollen joint count, ≥50% improvement in painful/tender joint count, and ≥50% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population|||Participants|||Number
1444138|NCT00903383|Primary|ACR20 Response at Week 12|Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).|Baseline and 12 weeks|Intent to Treat Population|||Participants|||Number
1444139|NCT00903370|Secondary|Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge||Less than 30 days post-procedure or hospital discharge||||percentage of patients||95% Confidence Interval|Number
1444140|NCT00903370|Primary|Freedom From Atrial Fibrillation||Measured at Month 12|Since the primary analysis is an intent-to-treat, outcomes were imputed for patients with missing data.|||percentage of patients||95% Confidence Interval|Number
1444141|NCT00903357|Primary|Changes in Urinary EDN|Changes of Urinary EDN(Eosinophil Derived Neurotoxin) after taking Montelukast or placebo drug. Urinary EDN levels were measured using an ELISA (MBL, Woburn, MA, USA) and the intra-assay and inter-assay variations were 3.0 ± 0.5 and 7.7 ± 1.5, respectively. Minimum value: 0, Maximum value: 2040 ng/ml.|18 weeks after participants recruitment||||Urine EDN (ng/ml)||Standard Deviation|Mean
1444142|NCT00903357|Primary|Changes in Urinary LTE4|Changes of Urinary LTE4(Leukotrien E4) after taking Montelukast or placebo drug. Urinary LTE4 levels were measured using an enzyme-linked immunoassay (ELISA) (Cayman Chemical, Michigan, USA) and the intra-assay and inter-assay variations were 7.4 ± 2.1 and 12.4 ± 7.8, respectively. Minimum value : 0 Maximum vlaue: 1000 pg/ml.|18 weeks after patient recruitment||||Urinary LTE4 (pg/ml)||Standard Deviation|Mean
1444143|NCT00903357|Primary|Changes in SCORAD Index|Changes of SCORAD(SCORing Atopic Dermatitis) index after taking Montelukast or placebo drug. SCORAD calculation: Extent(%)/5 + 7*Intensity/2 + subjective symptoms (minimum score 0, maximum score 103) (SCORAD index >40: severe, 15-40:moderate, <15: mild)|18 weeks after patient recruitment||||units on a scale||Standard Deviation|Mean
1444144|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months|difference in the mean|Change from Baseline to 6 Months||||grams/cm^2||Standard Deviation|Mean
1444145|NCT00903344|Secondary|Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months|difference in mean|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.|||grams/cm^2||Standard Deviation|Mean
1444146|NCT00903344|Secondary|Change in Bone Mineral Density (BMD) at HIP at 3 Months||Change from Baseline to 3 months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results.|||grams/cm^2||Standard Deviation|Mean
1444147|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 6 Months||Change from Baseline to 6 Months||||ng/ml||Standard Deviation|Mean
1444148|NCT00903344|Secondary|Change in 25-hyroxyvitamin D Levels at 3 Months|Difference in means between visits|Change from Baseline to 3 Months|At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for two of the groups' participants was not included in the results.|||ng/ml||Standard Deviation|Mean
1444149|NCT00903344|Primary|Change in Bone Mineral Density (BMD) in HIP at 6 Months||Change from Baseline to 6 months||||grams/cm^2||Standard Deviation|Mean
1444150|NCT00903331|Secondary|Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study|"Disease worsening was indicated by pulmonary function test/idiopathic pulmonary fibrosis worsening (PFT/IPF) or acute respiratory decompensation of IPF.~PFT/IPF worsening was indicated by the occurrence of both of the following: confirmed by two tests at least 4 weeks apart, as defined by the occurrence of both of the following: decrease from baseline ≥ 10% in forced vital capacity and decrease from baseline ≥ 15% in corrected diffusing capacity of the lung for carbon monoxide.~Acute respiratory decompensation of IPF was defined as an unexplained rapid deterioration (over a period of less than 4 weeks) of the patient’s condition with increasing shortness of breath requiring oxygen supplementation ≥ 5 L/min to maintain a resting oxygen saturation ≥ 90% or arterial oxygen pressure ≥ 55 mmHg (sea level) or 50 mmHg (high altitude)."|Up to end of study (Up to 24 months)|All randomized patients|||participants|||Number
1444151|NCT00903331|Primary|Forced Vital Capacity (FVC) at Baseline and End of Period 1|FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient’s measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing.|12 months|All randomized patients|||litres||95% Confidence Interval|Median
1444152|NCT00903201|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax)|Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL EDTA lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.|Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours|PK population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
1444153|NCT00903201|Secondary|Maximum Observed Plasma Drug Concentration (Cmax)|Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL EDTA lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.|Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours|PK population. Only those participants available at the specified time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1444154|NCT00903201|Secondary|Area Under the Plasma Drug Concentration (AUC) Versus Time Curve: AUC From Time Zero (Pre-dose) to Four Hours Post Dose (AUC[0-4]) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t])|Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL Ethylenediaminetetraacetic acid (EDTA) lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.|Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours|PK Population which comprised of all participants in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed.|||Nanogram * hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1444155|NCT00903201|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (Day 1) to Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||L||90% Confidence Interval|Mean
1444156|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D)|Blood samples intended for MMP-8 and MMP-9 analyses were collected in 4.0 mL lithium heparin greentopped collection tubes, then immediately mixed by gentle inversion five times. The samples were centrifuged at 1800 g for 15 minutes within 30 minutes of collection. A 2 mL volume of supernatant was transferred into a Sarstedt tube and subsequently centrifuged at 10000 g for 10 minutes at 2 to 8°C for complete platelet removal. A 1 mL volume of plasma supernatant was transferred into a Sarstedt tube and frozen at -70°C. Blood samples intended for SP-D were collected in 5.0 mL serum separator goldtopped blood collection tubes, then immediately mixed by gentle inversion 10 times. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 g for 15 minutes. Two 0.75 mL aliquots of serum supernatant were transferred separately into two Sarstedt tubes and frozen at -70°C. Plasma samples were centrally analyzed using a commercial test kit based on ELISA method.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1444157|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- Fibrinogen|Blood samples intended for fibrinogen analysis were collected in 4.5 mL 3.2 % sodium citrate blue-topped blood collection tubes, then immediately mixed by gentle inversion eight to ten times. Each sample was centrifuged at 1600 g for 15 minutes. A 1 mL volume of plasma supernatant was transferred via pipette into a Nunc tube, frozen at -20°C. Central analysis of fibrinogen in plasma samples was completed via photometric clot detection with automatic sample preparation.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed. One participant in the SB656933 20 mg arm had a fibrinogen reading on Day 14. This was not a planned visit schedule, therefore, fibrinogen levels were not analyzed for the placebo arm and SB656933 50 mg arm.|||Gram per liter||Geometric Coefficient of Variation|Geometric Mean
1444158|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- C-reactive Protein (CRP)|Blood samples intended for C-Reactive Protein (CRP) analysis were collected in 4.0 mL plain red-topped blood collection tubes. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 gram (g) for 15 minutes. A 1 mL volume of serum supernatant was transferred via pipette into a Nunc tube and stored at room temperature. Central analysis of CRP in serum samples was measured via fixed time nephelometry on the Behring Nephelometer II.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milligram per liter||Geometric Coefficient of Variation|Geometric Mean
1444159|NCT00903201|Secondary|Serum and Plasma Markers of Inflammation- Clara Cell Secretory Protein (CC-16) and CXCL8 (Interleukin-8 [IL-8])|Blood samples intended for CC-16 and CXCL8 were collected in 5.0 milliliter (mL) serum separator goldtopped blood collection tubes, then immediately mixed by gentle inversion 10 times. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 g for 15 minutes. Two 0.75 mL aliquots of serum supernatant were transferred separately into two Sarstedt tubes and frozen at -70 degree Celsius (°C). Plasma samples intended for CC-16 and CXCL8 were centrally analyzed using a commercial test kit based on enzyme-linked immunosorbent assay (ELISA) method.|Day 14 and Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
1444160|NCT00903201|Secondary|Induced Sputum Inflammatory Markers-Myeloperoxidase and Neutrophil Elastase|Sputum samples were taken after bronchodilation. Mean induced sputum inflammatory markers namely Myeloperoxidase and neutrophil elastase are presented.|Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Nanogram/microgram||Geometric Coefficient of Variation|Geometric Mean
1444161|NCT00903201|Secondary|Induced Sputum Neutrophil Percentage|Sputum samples were taken after bronchodilation and percentage of neutrophils in induced sputum are presented.|Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Percentage of neutrophil cells||Standard Deviation|Mean
1444162|NCT00903201|Secondary|Induced Sputum Neutrophil Number|Sputum samples were taken after bronchodilation and number of neutrophils in induced sputum were reported.|Day 28|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^4 cells/gram||Geometric Coefficient of Variation|Geometric Mean
1444163|NCT00903201|Secondary|Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum|Bacterial colony count of both Pseudomonas aeruginosa and Staphylococcus aureus in sputum were performed. Participants were graded as no bacteria in sputum, 1+, 2+, 3+ and 4+, which indicated proportional concentration of Pseudomonas aeruginosa and Staphylococcus aureus in sputum, where no bacteria indicated there was no bacteria in sputum, 1+ indicated slightly positive and 4+ indicated highly positive. Higher grades (4+) indicated worst outcomes (highly infected sputum). Number of participants with Pseudomonas aeruginosa and staphylococcus aureus count in sputum are presented.|Day 1 and Day 28||||Participants|||Count of Participants
1444164|NCT00903201|Primary|Number of Participants With Cystic Fibrosis (CF) Exacerbation|CF is one of the most common, lethal, autosomal recessive disease characterized by airway obstruction, bronchiectasis and infection, and exocrine pancreatic insufficiency. Number of participants with CF exacerbation are presented.|Day 1 to Day 42|All Subjects Population.|||Participants|||Count of Participants
1444165|NCT00903201|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Prior to ECG recordings, all participants rested for at least 5 minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Participants avoided hot and cold food for at least 30 minutes prior to an ECG measurement. Any results falling outside normal range were repeated at the discretion of the Investigator. ECG Baseline values taken within 2.5 hours prior to first dose were calculated using the mean value of triplicate pre-dose readings. Triplicate readings were taken at least five minutes apart. Participants agreed to abstain from hot and cold drinks and food prior to an ECG measurement. ECG machine calculated heart rate and measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant [NCS] and clinically significant [CS]) electrocardiogram (ECG) findings are presented.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
1444166|NCT00903201|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|The potential clinical concern range for clinical chemistry parameters were: glucose (low: < 2.8 millimole [mmol]/L and high: > 9.4 mmol/L), creatine kinase (high: > 3 * upper limit of normal units [ULN]/L), phosphorous, inorganic (low: < 0.8 mmol/L and high: > 1.6 mmol/L), total bilirubin (high: ≥ 1.5 * ULN micromole [μmol]/L), uric acid (low: < 41.636 μmol/L and high: > 582.904 μmol/L), alkaline phosphatase (ALP) (high: ≥ 2 * ULN international units [IU/L]/L), gamma glutamyl transpeptidase (GGT) (high: ≥ 110 IU/L), carbon dioxide content (low: < 18 mmol/L and high: > 32 mmol/L), direct bilirubin (high: > 1.5 * ULN μmol/L), potassium (low: < 3.0 mmol/L and high: > 5.5 mmol/L) and aspartate aminotransferase (AST) (high: ≥ 3* ULN IU/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry abnormalities of potential clinical importance.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
1444167|NCT00903201|Primary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance|Hematology parameters were reviewed prior to participants receiving first dose of study medication. The potential clinical concern range for hematology parameters were: Red blood cell (RBC) count (low: < 3.72 * 10^12/Liters (L) and high: > 6.313 * 10^12/L), lymphocytes (low: < 0.8 gigacells/L), hematocrit (low: > 0.075 ratio change from Baseline and high: > 0.54 ratio), mean cell hemoglobin (MCH) (low: < 23.8 picograms (pg) and high: > 39.6 pg), mean cell volume (MCV) (low: <73 femtoliters (FL) and high: >110 FL), platelet count (low: < 100 gigacells/L and high: > 550 gigacells/L), white blood cell (WBC) count (low: < 3 gigacells/L and high: > 20 gigacells/L) and eosinophils (high: > 1 gigacells/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with hematology abnormalities of potential clinical importance are presented.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
1444168|NCT00903201|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital signs included heart rate, systolic and diastolic blood pressure and body temperature. Prior to vital signs all participants rested for at least five minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Any results falling outside the normal range were repeated at the discretion of the Investigator. Potential clinical concern range for systolic blood pressure: <85 and >160 millimeter of mercury (mmHg), for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.|Up to Follow-up (up to 42 days)|All Subjects Population.|||Participants|||Count of Participants
1444169|NCT00903201|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to Follow-up (up to 42 days)|All Subjects population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
1444170|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Mean
1444171|NCT00903175|Secondary|Time to Definitive Deterioration of the Fatigue Scale of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444172|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444173|NCT00903175|Secondary|Time to Definitive Deterioration of the Global Health Status/QoL Scores of the EORTC QLQ-C30 by First-Line Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444174|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning Scale of the EORTC QLQ-C30 - by First and Second-Line Drugs Combined|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items.The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line or second line treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444194|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
1444680|NCT00895947|Post-Hoc|Acute Respiratory Illness|"Number of subjects in each group meeting definition of acute respiratory illness (ARI), defined as 2 or more cold/flu symptoms reported in the same week. Further defined as febrile or afebrile depending on whether the subject reported the symptom of feverishness."|16 weeks||||participants|||Number
1444175|NCT00903175|Secondary|Time to Definitive Deterioration of the Physical Functioning (PF) Scale of the EORTC QLQ-C30 - by First-Line (1L) Drug|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) contains 30 items. These include a global health status/QoL scale, five functional scales, three symptom scales, and six single items. The standardized score for the PF, fatigue subscales and global health status ranges from 0 to 100, with a higher score representing a high level of functioning/high level of symptom/high quality of life. Definitive deterioration by at least 10% was defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the first line of treatment. A single measure reporting a decrease of at least 10% was considered definitive only if it was the last one available for the participant.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444176|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First and Second-line Drugs Combined|The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L or 2-L treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444177|NCT00903175|Secondary|Time to Definitive Deterioration of the FKSI-DRS Risk Score by at Least 3 Score Units by First-line Drug|The Functional Assessment of Cancer Therapy – Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) is a set of items to assess symptoms experienced by patients with advanced kidney cancer. These symptoms include fatigue, pain, weight loss, dyspnea, cough, fever and hematuria. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration was defined as a decrease by at least 3 units compared to baseline, with no later increase above this threshold observed during the 1-L of treatment. A single measure reporting a decrease of at least 3 units was considered definitive only if it was the last one available for the patient.|<=14 days prior to the first dose of study medication, on day 1, day 28 of every cycle, at the end of treatment visit, at the 28 day FUP visit and monthly thereafter for up to 3 months or until initiation of another anticancer therapy up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444178|NCT00903175|Secondary|Duration of Response (DoR) - First-Line (1-L)|Duration of overall response (CR or PR) applies only to patients whose Best Overall Response (BOR) was Complete Response (CR) or Partial Response (PR) during the first-line treatment period. The start date was the date of first documented response (CR or PR) during the first-line treatment and the end date was the date of the event defined as the first documented progression or death due to underlying cancer during or after the same treatment line.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The analysis population corresponds to the patients included in the Full analysis set (i.e. randomized patients analyzed according to the treatment and stratum they were assigned to at randomization) and who achieved a best overall response of CR or PR during the first-line treatment period.|||Months||95% Confidence Interval|Median
1444179|NCT00903175|Secondary|Overall Response Rate (ORR) - First -Line (1-L)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) and was based on investigator assessment of radiology data per RECIST. Participants with best overall response of ‘Unknown’ were treated as non-responders in the calculation of the ORR. Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Radiological assessments : every 12 weeks until disease progression, the start of another antineoplastic therapy or for any other reason.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||percentage of participants|||Number
1444180|NCT00903175|Secondary|Overall Survival (OS)|Overall survival was defined as the time from date of randomization to date of death due to any cause. The analysis of OS included all deaths in the FAS regardless of when they were observed.|Every 2 months from randomization up to 3 years after last patient randomized|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444195|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
1444681|NCT00895947|Secondary|Incidence/Severity of Viral Respiratory Infections|Number of subjects in each group with a confirmed viral respiratory infection and the proportion of subjects reporting a mild vs. moderate to severe infection|16 weeks||||participants|||Number
1444181|NCT00903175|Secondary|Progression-free Survival Combined (PFS-C)|PFS-C (1L and 2L study drugs combined) was a composite endpoint which combined both lines of study treatment. It was defined as the time from the date of randomization to the first of the following: date of death due to any cause, or date of the first radiologically documented progression disease during or after the second-line treatment period for patients with a radiologically documented progression disease in the first-line treatment period and who had crossed-over to second-line treatment no more than 6 weeks after progression.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to about 56 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444182|NCT00903175|Primary|Progression Free Survival First-Line (PFS 1-L)|PFS_1L based on investigator assessment of radiology data by RECIST 1.0, was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause during or after first-line treatment with everolimus or sunitinib. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|based on radiological assessments every 3 months until disease progression, start of another antineoplastic therapy or for any other reason up to 35 months|The Full Analysis Set (FAS) consists of all randomized patients analyzed according to the treatment and stratum they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1444183|NCT00903162|Secondary|The Effect of OFS Combined With Aromatase Inhibitor Therapy on the Incidence and Severity of Menopausal Symptoms, Sexual Dysfunction, Musculoskeletal Complaints, Other Side Effects and Overall Quality of Life.|OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.||||||
1444184|NCT00903162|Secondary|Ovarian Function Suppression (OFS) Combined With Aromatase Inhibition Combined With Intravenous Bisphosphonate Therapy on Bone Mineral Density.|Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.|2 years|This data was not collected nor analyzed because of too few participants to be meaningful.||||||
1444185|NCT00903162|Primary|Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.|The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.|1 year|Between September 15, 2009, and January 18, 2013, 17 patients were enrolled, but only 16 actually began protocol-directed treatment. Of the 16, 4 stopped treatment before completing even 1 year of protocol-directed therapy, owing to toxicity.|||participants|||Number
1444186|NCT00903032|Primary|Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB)|The primary outcome was the proportion of patients who were adherent to cardioprotective medications (beta-blockers, statins, clopidogrel, and ACE/ARB) in the year following ACS hospitalization.|12-months|Composite Adherence* (PDC>0.80) (%)|||percentage of participants|||Number
1444187|NCT00903006|Primary|Patient Response (+ Time to Disease Progression)||Baseline, after two 28 day cycles, until disease progression.|||||||
1444188|NCT00903006|Primary|Phase I Maximum Tolerated Dose (MTD) for Dose Level 1|"Maximum Tolerated Dose (MTD) defined as the dose or dose-combination that has the mean posterior toxicity rate closest to the target toxicity rate of 0.33. Dose levels reviewed with each 28 day cycle. Treatment dose levels:~Fulvestrant will be given using a loading dose of 500 mg intramuscularly (IM) on day 1 as two 250 mg/5 ml injections, followed by 500 mg IM on day 15 and on day 1 of each subsequent 28- day (+/- 2 days) cycle.~MK-0646 will be given intravenously on days 1,8, 15, and 22 for each cycle at one of the two dose levels: 1) 5 mg/kg or 2) 10 mg/kg (Dose level 1)~Dasatinib will be given orally (PO) continuously on days 1 -28 for each cycle at one of two dose levels: 1) 70 mg po daily or 2) 100 mg po daily"|28 day cycle|Study terminated early; Analysis not available due to smaller sample size.||||||
1444189|NCT00902850|Primary|Clinical Performance|Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.|Insertion, 4 hours & End of Day|All eligible participants|||units on a scale|||Number
1444190|NCT00902746|Secondary|Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.|||units on a scale||Standard Deviation|Mean
1444191|NCT00902746|Primary|Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|52 weeks|This analysis was carried out for 112 patients whom end of study data was available on FAS.|||units on a scale||Standard Deviation|Mean
1444192|NCT00902668|Primary|Proportion of Good/Excellent Cosmetic Outcome During the First 5 Years After Radiotherapy|Proportion of good or excellent cosmetic outcomes, assessed using the Harvard Cosmesis Scale|during the first 5 years after treatment|Due to slow accrual the study was closed to accrual and all 3 participants were terminated. No data was analyzed.||||||
1444193|NCT00902564|Secondary|Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks|Observed Cases (OC)|||percentage of patients|||Number
1444196|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
1444197|NCT00902564|Secondary|Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks||||percentage of patients|||Number
1444198|NCT00902564|Secondary|Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks||||percentage of patients|||Number
1444199|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
1444200|NCT00902564|Secondary|Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
1444201|NCT00902564|Primary|Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)|The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56.|baseline and 8 weeks||||scores on a scale||Standard Deviation|Mean
1444202|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour systolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
1444203|NCT00902538|Secondary|In Non-responders, the Change in 24-hour Diastolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|In non-responders, the change in 24-hour diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement from the beginning to the end of Period 4.|Week 16 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
1444204|NCT00902538|Secondary|In Non-responders, the Number of Subject Meeting Their Blood Pressure Goals Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|The number of non-responding participants who achieved their blood pressure goals at the end of Period 4. Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||Participants|||Number
1444205|NCT00902538|Secondary|In Non-responders, the Change in Seated Systolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated systolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
1444206|NCT00902538|Secondary|In Non-responders, the Change in Seated Diastolic Blood Pressure Associated With the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg.|Change in seated diastolic blood pressure from the beginning to the end of Period 4. Three cuff blood pressure measurements were taken at each visit.|week 24 to week 32|The analysis population includes those participants who had blood pressure values at both the beginning and end of Period 4.|||mm Hg||Standard Error|Least Squares Mean
1444207|NCT00902538|Secondary|Change in 24-hour Systolic Blood Pressure Assessed by 24-hour Ambulatory Blood Pressure Measurement.|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
1444208|NCT00902538|Secondary|Change in 24-hour Diastolic Blood Pressure (DBP) Assessed by 24-hour Ambulatory Blood Pressure Measurement (ABPM).|Three cuff blood pressure measurements were taken at each visit.|Baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
1444209|NCT00902538|Secondary|Number of Subjects Achieving Blood Pressure (BP) Goal at Week 16.|Achieving blood pressure goal is defined as seated blood pressure <140/90 mm Hg; 130/80 mm Hg for participants with diabetes and/or other chronic renal and/or chronic cardiovascular disease. Three cuff blood pressure measurements were taken at each visit.|baseline (week 8) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||Participants|||Number
1444210|NCT00902538|Secondary|Change in Seated Systolic Blood Pressure (SeSBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to week 16|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
1444211|NCT00902538|Primary|Change in Seated Diastolic Blood Pressure (SeDBP) of the Triple Combinations OM/AML/HCTZ 40/10/12.5 and 40/10/25 mg vs. OM/AML 40/10 mg|Three cuff blood pressure measurements were taken at each visit.|baseline (8 weeks) to 16 weeks|The Full Analysis Set 1 included 806 randomized subjects who received at least 1 dose of double-blind study medication in Period II and provided at least 1 SeDBP measurement in Period II: 269 subjects in the OM/AML 40/10 mg group, 268 subjects in the OM/AML/HCTZ 40/10/12.5 mg group, and 269 subjects in the OM/AML/HCTZ 40/10/25 mg group.|||mm Hg||Standard Error|Least Squares Mean
1444212|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at End of Chemotherapy for quality of life scores.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||correlation coefficient|||Number
1444213|NCT00902330|Secondary|Effects of Treatment on Quality of Life - Means at End of Treatment|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not al all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|up to 2 weeks after completion of study treatment, for up to 8 months||||units on a scale||Standard Error|Least Squares Mean
1444214|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at End of Chemotherapy|Simple correlations will be computed at end of Chemotherapy for symptoms.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||correlation coefficient|||Number
1444215|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||units on a scale||Standard Deviation|Mean
1444216|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment|Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks afer completion of study treatment, for up to 8 months||||correlation coefficient|||Number
1444217|NCT00902330|Secondary|Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed after completion of study treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Up to 2 weeks after completion of study treatment, for up to 8 months||||Log (pg/ml)||Standard Deviation|Mean
1444218|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores.|Midpoint Chemotherapy, up to 4 months||||correlation coefficient|||Number
1444219|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Midpoint Chemotherapy, up to 4 months||||units on a scale||Standard Deviation|Mean
1444220|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for symptoms.|Midpoint Chemotherapy, up to 4 months||||correlation coefficient|||Number
1444221|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Midpoint Chemotherapy, up to 4 months||||units on a scale||Standard Deviation|Mean
1444222|NCT00902330|Secondary|Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Midpoint Chemotherapy, up to 4 months||||correlation coefficient|||Number
1444225|NCT00902330|Secondary|Relationships Among Quality of Life Scores - Means at Baseline|Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.|Baseline||||units on a scale||Standard Deviation|Mean
1444226|NCT00902330|Secondary|Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy|Simple correlations will be computed at Baseline Chemotherapy for symptoms.|Baseline||||correlation coefficient|||Number
1444227|NCT00902330|Secondary|Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline|Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.|Baseline||||units on a scale||Standard Deviation|Mean
1444228|NCT00902330|Secondary|Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline||||correlation coefficient|||Number
1444229|NCT00902330|Secondary|Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).|Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.|Baseline|Per protocol, for all subjects with available data. No imputation was utilized.|||Log(pg/ml)||Standard Deviation|Mean
1444230|NCT00902330|Secondary|To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.|Examine correlations between the symptoms at baseline to determine a general pattern of association. Factor analysis (a statistical method used to describe variability among observed, correlated variables in terms of a potentially lower number of unobserved variables called factors) was performed to examine how these 5 symptoms cluster. A principal component factor analysis was performed on the correlation matrix for the symptom scores of anxiety, depression, pain, fatigue and sleep disturbance at up to two weeks after completion of study treatment, up to 8 months). For each analysis two factors were retained that explained 74% of the variability for the baseline symptom scores, 79% of the variability of the symptom scores at the midpoint and 78% of the variability in symptom scores at study completion. A varimax rotation was utilized and the factor loadings from the varimax rotation were reported.|up to 2 weeks after completion of study treatment, for up to 8 months||||Rotated factor loading multiplied by 100|||Number
1444231|NCT00902330|Primary|Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer|Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire|Up to 2 weeks afer completion of study treatment, for up to 8 months||||units on a scale||Standard Deviation|Least Squares Mean
1444232|NCT00902304|Secondary|Number of Patients With Major Clinical Endpoints|Major clinical endpoints measured were all-cause mortality and fatal and non-fatal cardiovascular events (e.g. acute myocardial infarction, stroke and heart failure).|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.|||participants|||Number
1444233|NCT00902304|Secondary|Rate of Treatment Compliance|The rate of compliance was planned to be estimated from the quantity of unused medication returned at each scheduled visit over the entire follow-up period. Rate of compliance = (tablets supplied - tablets returned)/(tablets for 100% compliance).|26 weeks|This data will not be analyzed due to the poor quality of the data.||||||
1444234|NCT00902304|Secondary|Change in Self-care Behavior Score From Baseline to Week 26|A modified self-care behavior tool (questionnaire) was used to calculate 2 domain scales: maintenance and confidence. Each domain has a standardized score between 0 and 100. Self-care is best represented by maintenance. Confidence is an important process that moderates the relationship between self-care and outcomes. Higher index score suggests better self-care. A score of 70 or greater can be used as the cut-point to judge self-care adequacy.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||Change in score||Standard Deviation|Mean
1444255|NCT00902265|Primary|Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12|The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||Number of nocturnal voids||Standard Deviation|Mean
1444235|NCT00902304|Secondary|Participants With End Organ Disease at Baseline and Week 26|"A patient was considered to have end organ damage with either of the following: 1) proteinuria (dipstick = 1+ or more or protein/creatinine ratio > 30mg/mol or 24h urine protein > 0.3g); 2) no proteinuria, but presence of microalbuminuria (urine albumin/creatinine ratio 3.6 to 25mg/mol(male) or 3.6 to 35mg/mol (female) detected; 3) no proteinuria or microalbuminuria, but presence of macroalbuminuria (urine albumin/creatinine ratio > 25mg/mol(male) or >35mg/mol (female) detected OR 4) ECG evidence of LVH (Sokolow-Lyon voltage criteria values >= 38mm).~Baseline potential for end organ damage was calculated in all 1562 randomised patients based on the criteria outlined above. If no investigation/data available, assumed no end-organ damage.~It is important to note that given the limited number of ECGs at 26 weeks, between group comparisons should be limited to the two time points (baseline and 26 weeks)."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.|||participants|||Number
1444236|NCT00902304|Secondary|Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26|"The CES-D score was from 0 to 30, with a higher score indicating a higher level of depression.~The categories for the score are: 0 to 9 suggests no depression; 10 to 15 suggests mild depression; 16 to 24 suggests moderate depression; 24 or above suggests severe depression."|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||change in CES-D score||Standard Deviation|Mean
1444237|NCT00902304|Secondary|Number of Patients With Depression|Patients with depression refers to potential depressive symptoms, not clinically diagnosed depression. The 2 question Arrol screening tool was used to determine if the patient had potential depressive symptoms. The 2 questions are: During the last month have you often been bothered by feeling down, depressed or hopeless? During the past month have you often been bothered by little interest or pleasure in doing things? The presence of potential depressive symptoms was determined by a 'yes' answer to either of these questions.|Baseline and week 26|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||participants|||Number
1444238|NCT00902304|Secondary|Change in the EQ-5D Score|The EQ-5D total indexed score (AUS) measures self-reported quality of life with the following 5 dimensions: mobility (range 1,2,3), self-care (range 1,2,3), usual activity (range 1,2,3), pain/discomfort (range 1,2,3) and anxiety/depression (range 1,2,3), where a 1 indicates no problems, a 2 indicates moderate problems, and a 3 indicates severe problems. The range of possible utility scores are between -0.217 (derived from worse responses from all 5 dimensions with severe problems ie 3,3,3,3,3) and 1.000 (no problems for all 5 dimensions) for each dimension. An increase in EQ-5D indexed score (AUS) indicates improvement.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||change in EQ-5D score||95% Confidence Interval|Mean
1444239|NCT00902304|Secondary|Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments|A comparison of the early responders was made based on the blood pressure measurements taken at the week 6 visit window according to gender and guideline targets. The guideline targets were: patients with renal impairment: 125/75 mmHg; patients with end-organ damage/cardiovascular disease: 130/80 mmHg; others: 140/90 mmHg.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization.|||Participants|||Number
1444240|NCT00902304|Secondary|Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy|The rate of all adverse events by preferred terms as determined by the General Practice investigators to be related to study intervention therapy was reported. Percentage of adverse events was calculated based on the number of participants analyzed. 41 adverse events were not reported as inadequate information was supplied to allow determination of drug treatment at onset.|26 weeks|Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment.|||participants|||Number
1444241|NCT00902304|Secondary|Change in Absolute Cardiovascular Risk Score|"The absolute cardiovascular risk assessment uses the Framingham Risk Equation to predict risk of a cardiovascular event over the next 5 years. A score of <10% is a low risk, 10 to 15% is a moderate risk, and >15% is a high risk.~A decrease indicates improvement."|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis.|||percentage risk score change||Standard Deviation|Mean
1444242|NCT00902304|Secondary|Change in Mean Sitting Diastolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.|||mmHg||95% Confidence Interval|Least Squares Mean
1444254|NCT00902265|Secondary|Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12|The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||ratio||Standard Deviation|Mean
1444243|NCT00902304|Secondary|Change in Mean Sitting Systolic Blood Pressure|The visit window was from 22 to 36 weeks. If more than one blood pressure measure was available within the specified window, then the one closest to the scheduled visit was used for analysis. If no measure was available within this window, then the last recorded BP post-randomization was used for the endpoint. Analysis of covariance model was used with the factors: baseline blood pressure, treatment and blood pressure target group at randomization.|Baseline and 26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.|||mmHg||95% Confidence Interval|Least Squares Mean
1444244|NCT00902304|Primary|Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target|BP target groups were: <= 125/75mmHg, <= 130/80mmHg and <= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.|26 weeks|Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis.|||percentage of participants|||Number
1444245|NCT00902278|Secondary|Antibody Responses Following Immunization|Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group|Prevaccination and approximately 1 month post vaccination|Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for the flulaval group. Only participants with evaluable data were included in this analysis.|||fold change||95% Confidence Interval|Geometric Mean
1444246|NCT00902278|Primary|T Cell Responses Following Immunization|Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups|Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination|Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for Flulaval group.Only participants with evaluable data were included in the analysis.|||fold change||Standard Deviation|Mean
1444247|NCT00902265|Secondary|Participants With Treatment Emergent Adverse Events (AEs)||Week 1 to Week 12|Safety Population, consisting of participants who took at least one dose of desmopressin|||Participants|||Number
1444248|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
1444249|NCT00902265|Secondary|Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)|The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
1444250|NCT00902265|Secondary|Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12|The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
1444251|NCT00902265|Secondary|Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL).|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).|||Units on a scale||Standard Deviation|Mean
1444252|NCT00902265|Secondary|Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12|The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||Units on a scale||Standard Deviation|Mean
1444253|NCT00902265|Secondary|Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12|Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 – baseline.|Baseline, Week 12|Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)|||Hours||Standard Deviation|Mean
1444256|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
1444257|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
1444258|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|baseline and 12 weeks|Due to data being unavailable, 22 participants were analysed for this outcome, in contrast with 30 participants for the other outcomes.|||scores on a scale||Standard Deviation|Mean
1444259|NCT00902226|Secondary|Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks||||percentage of patients|||Number
1444260|NCT00902226|Secondary|Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks||||percentage of patients|||Number
1444261|NCT00902226|Secondary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
1444262|NCT00902226|Primary|Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|baseline and 12 weeks||||scores on a scale||Standard Deviation|Mean
1444263|NCT00902174|Secondary|Plasma Concentration of QTI571 400 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.~The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.|||ng/mL||Standard Deviation|Mean
1444264|NCT00902174|Secondary|Plasma Concentration of QTI571 200 mg and Its Metabolite (GCP74588) Pre-dose and Between 0 Hour to 3 Hour Post-dose Per Participant|"Blood samples were taken from each subject participating in the study (placebo group and active treatment group) once predose and once between 0 hour to 3 hour post dose at day 1 (baseline), day 14, day 28 and day 168.~The parent compound QTI571 and its active metabolite, GCP74588, were measured in plasma by validated liquid chromatography-mass spectrometry (HPLC-MS/MS) assay."|predose and between 0 hour to 3 hour post dose at day 1, day 14, day 28 and day 168|The Full Analysis Set includes all patients who received at least one dose of study drug with available blood samples for analysis.|||ng/mL||Standard Deviation|Mean
1444265|NCT00902174|Secondary|Covariance of End of Study CAMPHOR Score|The CAMPHOR test consists of 65 items and 3 scales. Two scales measure Health Related Quality of Life. 1) Symptoms: consists of 25 items measuring loss or abnormality of psychological, physiological or anatomical structure or function; further sub-divided into 3 subscales (energy, breathlessness and mood), 2) Disability: consists of 15 items measuring any restriction or lack of ability to perform an activity. 3) Quality of Life (QOL): consists of 25 items defining how individuals perceived ability and capacity to satisfy their needs. The 25-item symptom and QOL scales score from 0-25 where a higher score indicates the presence of more symptoms and poor QOL, respectively. The 15-item functioning scale scores 0-30; a higher score indicates poor functioning.|Week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Error|Least Squares Mean
1444266|NCT00902174|Secondary|Change in Borg Dyspnea Score During 6-minute Walk Test|Change in Borg scale was measured at different time points at week 24. The Borg Scale consists of scale range of 0 to 10. Participants pointed to indicate their level of dyspnea before and at the end of exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). A reduction in this score indicates an improvement.|week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||units on a scale||Standard Deviation|Mean
1444267|NCT00902174|Secondary|Change From Baseline in Heart Rate|Change from baseline in heart rate (bpm) was measured via right heart catheterization according to the local hospital procedures. The heart rate was assessed when the participant was in a stable hemodynamic rest state.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||bpm||Standard Error|Least Squares Mean
1447280|NCT00873457|Secondary|Overall Survival|Overall survival is defined as the length of time between discontinuation of perifosine until death or 2 year's followup, whichever comes first.|up to a maximum of 2 years|All treated patients|||Days||Full Range|Median
1444268|NCT00902174|Secondary|Change From Baseline in Diastolic Arterial Blood Pressure|Change from baseline in diastolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The diastolic arterial blood pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
1444269|NCT00902174|Secondary|Change From Baseline in Systolic Arterial Blood Pressure|Change from baseline in systolic arterial blood pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The systolic arterial blood was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
1444270|NCT00902174|Secondary|Change From Baseline in Cardiac Output|Change from baseline in cardiac output (L/min) was measured via right heart catheterization according to the local hospital procedures. The cardiac output was assessed when the participant was in a stable hemodynamic rest state. An increase from baseline (higher number) in cardiac output indicates improvement.|24 weeks|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||Liters/minute||Standard Error|Least Squares Mean
1444271|NCT00902174|Secondary|Change From Baseline in Pulmonary Resistance Index|Change from baseline in pulmonary resistance index (dynes*sec*cm^-5/m2) was measured via right heart catheterization according to the local hospital procedures. The pulmonary resistance index was assessed when the participant was in a stable hemodynamic rest state. A reduction from baseline in pulmonary resistance index indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||dynes*sec*cm^-5/m2||Standard Error|Least Squares Mean
1444272|NCT00902174|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Change from baseline in pulmonary vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The pulmonary vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in pulmonary vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||dynes*sec*cm^-5||Standard Error|Least Squares Mean
1444273|NCT00902174|Secondary|Change From Baseline in Systemic Vascular Resistance|Change from baseline in systemic vascular resistance (dynes*sec*cm^-5) was measured via right heart catheterization according to the local hospital procedures. The systemic vascular resistance was assessed when the participant was in a stable hemodynamic rest state. Reduction from baseline in mean systemic vascular resistance indicates improvement.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||dynes*sec*cm^-5||Standard Error|Least Squares Mean
1444274|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Capillary Wedge Pressure|Change from baseline in mean pulmonary capillary wedge pressure (mmHg)was measured via right heart catheterization according to the local hospital procedures. The right atrial mean pulmonary capillary wedge pressure was assessed when the participant was in a stable hemodynamic rest state.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
1444275|NCT00902174|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure|Change from baseline in mean pulmonary arterial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The mean pulmonary arterial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher mean pulmonary arterial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis|||mm Hg||Standard Error|Least Squares Mean
1444276|NCT00902174|Secondary|Change From Baseline in Right Atrial Pressure|Change from baseline in right atrial pressure (mmHg) was measured via right heart catheterization according to the local hospital procedures. The right atrial pressure was assessed when the participant was in a stable hemodynamic rest state. A higher right atrial pressure number indicates worsening.|baseline and week 24|Participants from the Full Analysis Set, defined as all randomized participants who received at least one dose of study drug, with data available for analysis.|||mm Hg||Standard Error|Least Squares Mean
1444277|NCT00902174|Secondary|Clinical Worsening Comparing Imatinib Versus Placebo for Adjudicated Cases|Clinical worsening per participant was measured by the onset of any adjudicated event (all cause mortality; overnight hospitalization for worsening of Pulmonary Arterial Hypertension (PAH); worsening of WHO functional class by one level; 15% decline in Six Minute Walk Distance (6MWD) measured on two consecutive occasions) at 24 weeks treatment, comparing imatinib to placebo groups. A cox regression analysis model was used.|24 weeks|The Full Analysis Set included all participants who received at least one dose of study drug and experienced an adjudicated event. A cox regression analysis model was used.|||percentage of participants|||Number
1444278|NCT00902174|Primary|Difference in Six-minute Walk Distance Test (6MWD) Between Imatinib and Placebo at 24 Weeks|This standardized walk course was 30 meters in length. During the walk the participant was connected to a portable pulse oximeter via a finger probe. Participants were instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. The total distance walked (in meters) was recorded. Results were compared between the 2 groups.|24 weeks|The Full Analysis Set includes all participants who received at least one dose of study drug and completed the 6MWD Six-minute walk test at week 24. Repeated measurement model was used for this analysis.|||meters||Standard Error|Least Squares Mean
1444308|NCT00901342|Primary|Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)||Day 0 (first infusion) and up to 3 infusions at 2-week intervals|Participants who Received At least 1 Infusion|||participants|||Number
1447367|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Cmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing||||umol/L||Geometric Coefficient of Variation|Geometric Mean
1444279|NCT00902161|Secondary|Number of Participants Who Discontinued Study Treatment Due To AEs|"An AE was defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)|All treated participants|||participants|||Number
1444280|NCT00902161|Secondary|Number of Participants With An Adverse Event (AE)|"An AE was defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product."|From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).|All treated participants|||participants|||Number
1444281|NCT00902161|Secondary|Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893|Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve|From time of MK0893 administration through estimated 32 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.|||nM||Standard Deviation|Mean
1444282|NCT00902161|Secondary|Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893|"Cmax was the maximum or “peak” concentration of MK0893 observed after its administration.~Approximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC [8-12]) ÷ 4"|From time of MK0893 administration through 24 hours post-dose|Data from the first 15 participants who completed the study were used for the pharmacokinetic analysis.|||uM||Standard Deviation|Mean
1444283|NCT00902161|Primary|Recovery Time (Rt[65] From Insulin-induced Hypoglycemia|Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within ~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes|From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes|21 participants who received MK0893 + Propanolol while on study had data available, and 17 participants who received Placebo + Propanolol while on study had data available|||minutes||95% Confidence Interval|Least Squares Mean
1444284|NCT00901901|Other Pre-specified|Tumor Response|Tumor response was the proportion of participants with the best tumor response (ie, achieving either a confirmed complete response [CR] or partial response [PR], according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants|||Participants|||Number
1444285|NCT00901901|Other Pre-specified|Time to Response|Time to response was the number of days from randomization to the date the CR or PR was documented (with confirmation) (Note: the relevant date is that of the first documentation, not the confirmation date).|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Time to response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.|||Days||95% Confidence Interval|Median
1444286|NCT00901901|Other Pre-specified|Duration of Response|Duration of response - RECIST: number of days from the date that CR or PR is first documented to date that PD is first objectively documented or to death before progression. Note: the relevant date is that of the first documentation, not the confirmation date (if participant progressed or died then censored=no) or to last observation if participant did not progress or die then censored=yes note: this last observation date should be the same as that used for time to progression.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants. Duration of response was evaluated in the 14 participants in the sorafenib + placebo group and 24 participants in the sorafenib + erlotinib group who achieved their confirmed best response as CR or PR.|||Days||95% Confidence Interval|Median
1444287|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - VAS|Participants indicated on a scale of 0 (worst) to 100 (best) how good or bad their health state was on that particular day.|The EQ-5D VAS was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1444288|NCT00901901|Secondary|Health-related Quality of Life and Utility Values as Measured by EQ-5D - Index|The European quality of life scale (5 dimensions) (EQ-5D) questionnaire was given to the participants at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 ‘no problems’; 2 ‘some problems’; 3 ‘extreme problems’). The 5 health dimensions are summarized into a single score, the EQ-5D index score. The EQ-5D index score has a range of 0 and 1 with 0 representing death and 1 representing perfect health.|The EQ-5D was administered at the beginning of the visit prior to seeing the investigator. Questionnaires were to be completed every 6 weeks (Day 1 of each cycle) for subsequent cycles and at the end of treatment visit.|The full analysis set (FAS), which was defined as all randomized participants|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1444922|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (Tmax)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
1444289|NCT00901901|Secondary|Disease Control|Disease control was defined as the number of participants who had a best response rating of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST assessed by magnetic resonance imaging (MRI) that was confirmed at least 28 days from the first demonstration of that rating. CR: disappearance of all clinical and radiological evidence of target and non-target tumors. PR: at least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage for PR nor sufficient increase for PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants|||Participants|||Number
1444290|NCT00901901|Secondary|Time to Radiological Tumor Progression (TTP)|TTP was the time from randomization to radiological tumor progression. Participants without radiological tumor progression at the time of analysis were censored at their last date of tumor evaluation. Progressive disease (PD) was defined using Response Evaluation Criteria in Solid Tumors (RECIST version 1.0), as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Appearance of new lesions also constituted PD.|From randomization of the first participant until 34 months later (cut-off date), assessed every 6 weeks|The full analysis set (FAS), which was defined as all randomized participants|||Days||95% Confidence Interval|Median
1444291|NCT00901901|Primary|Overall Survival|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.|From randomization of the first patient until 34 months or date of death of any cause whichever came first|The full analysis set (FAS), which was defined as all randomized participants|||Days||95% Confidence Interval|Median
1444292|NCT00901628|Secondary|Maximal Flexion Angle Degree on Postoperative 7 Day|An independent investigator measured the maximal flexion angle (degree) of replaced knee with 28 centimeter armed goniometer on postoperative 7 day|postoperative 7 day||||degree||Standard Deviation|Mean
1444293|NCT00901628|Secondary|The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended||24 hours postoperative||||participants|||Number
1444294|NCT00901628|Secondary|the Proportion of Patients Who Were Satisfied With the Pain Management||postoperative 7 day||||participants|||Number
1444295|NCT00901628|Secondary|Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery|An independent investigator assessed participant number of postoperative nausea and vomiting during 24 hours after surgery. Nausea was defined as a subjective unpleasant sensation associated with awareness of the urge to vomit; and vomiting, as the forceful expulsion of gastric contents from the mouth.|24 hours after surgery||||participants|||Number
1444296|NCT00901628|Secondary|Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery|Fentanyl based PCA consumption via PCA pump (microgram)|24 hours postoperative||||microgram||Standard Deviation|Mean
1444297|NCT00901628|Primary|Pain( Visual Analog Scale )|An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.|the night after surgery||||units on a scale||Standard Deviation|Mean
1444298|NCT00901576|Primary|T 1/2 of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1444299|NCT00901576|Primary|Tmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1444300|NCT00901576|Primary|AUC of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
1444301|NCT00901576|Primary|Cmax of d-Methylphenidate||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng/ml||Standard Deviation|Mean
1444302|NCT00901576|Primary|Time of Plasma Half-Life(T 1/2) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1444303|NCT00901576|Primary|Time of Maximum Plasma Concentration (Tmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||hours||Standard Deviation|Mean
1444304|NCT00901576|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|PKP|||ng*h/ml||Standard Deviation|Mean
1444305|NCT00901576|Primary|Maximum Plasma Concentration (Cmax) of Guanfacine||0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose|Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-methylphenidate. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
1444306|NCT00901459|Secondary|Change in Craving for Cigarettes After Controlled Smoke Presentations.|Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire (“Did it immediately reduce your craving for cigarettes?”) after smoking presentations through the controlled puff volume apparatus.|After smoking a cigarette through the controlled puff volume apparatus during rTMS||||units on a scale||Standard Deviation|Mean
1444307|NCT00901459|Primary|Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.|Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING (“urges to smoke,” “miss a cigarette,” and “crave cigarettes”), MOOD (“calm,” “tense,” and “irritable”), AROUSAL (“wide awake,” “able to concentrate”), and HUNGER (“feel hungry”). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving.|Following exposure to in vivo cues|A repeated measures design exposed participants to three different rTMS conditions over 3 separate visits, with order counterbalanced using latin square design.|||units on a scale||Standard Error|Mean
1444309|NCT00901316|Primary|Medically Attended Skin and Soft Tissue Infections (MA-SSI)|Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.|From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.||||percentage of partipants||95% Confidence Interval|Number
1444310|NCT00901303|Primary|36-Month Progression-free Survival Rate|Progression-free survival is defined as the length of time from study intervention to disease progression or death|36 months|Data was not collected due to early termination of the study.||||||
1444311|NCT00901225|Secondary|Platelet Engraftment|Days to platelet count >20,000|12 months||||days||Full Range|Median
1444312|NCT00901225|Secondary|Number of Subjects Experiencing Durability of Engraftment|Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.|12 months||||participants|||Number
1444313|NCT00901225|Secondary|Days to Absolute Neutrophil Count >500||12 months||||days||Full Range|Median
1444314|NCT00901225|Secondary|Number of Subjects Experiencing Graft Failure|To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).|12 months||||participants|||Number
1444315|NCT00901225|Secondary|Number of Participants Experiencing a Grade III/IV Toxicity|Safety of plerixafor as measured by Grade III/IV Toxicity|6 months post transplant or until relapse||||participants|||Number
1444316|NCT00901225|Primary|Number of Participants Who Achieved > or Equal to 2 X 10(6)CD34+ Cells/kg Within 3 Days of Apheresis After Receiving Plerixafor With G-CSF.||5 days after receiving G-CSF||||participants|||Number
1444317|NCT00901186|Secondary|Percentage of CRT Change From Baseline by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.|||Percentage change||Standard Deviation|Mean
1444318|NCT00901186|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT) by Study Visit|CRT was assessed by Optical Coherence Tomography (OCT).|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month CRT values were included in the analysis.|||micrometers||Standard Deviation|Mean
1444319|NCT00901186|Secondary|Percentage of Participants With VA > 73 Letters With Ranibizumab (0.5 mg) vs Laser.|VA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.|||Percentage of participants|||Number
1444320|NCT00901186|Secondary|Evolution of Mean Change From Baseline in BCVA by Study Visit|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|ITT: The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. For each month, participants who had both the baseline and the study month BCVA values were included in the analysis.|||letters||Standard Deviation|Mean
1444321|NCT00901186|Secondary|Percentage of Participants With Improvement in BCVA|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value.|||Percentage of participants|||Number
1444322|NCT00901186|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, 12 months|Intent-to-treat (ITT): The ITT consisted of all randomized participants who received at least one intravitreal ranibizumab injection of one laser photocoagulation treatment for whom there was at least one baseline and one post-treatment BCVA value. Participants who had both Baseline and Month 12 BCVA values only were included in this analysis.|||letters||Standard Deviation|Mean
1444323|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|12 months||||% of implants|||Number
1444367|NCT00900146|Primary|Change From Baseline in Dynamic Phase Secreted Insulin Per Unit of Glucose Concentration (Φd) Over 4 Months (Period III)|This was planned as interim analysis and was not conducted because the study was terminated in period III.|Baseline, Over Month 4|The benefit of canakinumab for the treatment of patients with type 2 diabetes mellitus in combination with metformin was inadequate to continue patients into Period IV in the present study, and therefore decided to terminate the study during Period III.|||pmol/min/m2/mmol* hour/L||Standard Error|Least Squares Mean
1444324|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility (based on hand testing)~Absence of a peri-implant infection with suppuration.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|12 months||||% of implants|||Number
1444325|NCT00901017|Secondary|Implant Survival Rate|"A surviving implant will be considered an implant fulfilling the following criteria:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Absence of pain or any other adverse observation by the patient, so that the implant has to be removed."|6 Months||||% of implants|||Number
1444326|NCT00901017|Secondary|Implant Success Rate|"The success of oral implant will be determined according to the following parameters:~Absence of any continuous peri-implant radiolucency based on radiographic findings.~Absence of implant mobility (based on hand testing)~Absence of a peri-implant infection with suppuration.~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics).~Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection."|6 months||||% of implants|||Number
1444327|NCT00901017|Primary|Change of Vertical Height of Buccal Defects|Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery|Baseline to 26 weeks|14 patients represented the ITT population.|||mm||95% Confidence Interval|Mean
1444328|NCT00900822|Secondary|Implant Success Rate|Implant success is defined as the absence of any continuous peri-implant radiolucency based on radiographic findings, absence of implant mobility, absence of a recurrent per-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more 3-month follow-up visits after treatment with systemic antibiotics), and bone level changes around the implant less than 1 mm during the first year of loading and less than 0.2 mm per year thereafter.|12 months after loading the implant||||percentage of implants|||Number
1444329|NCT00900822|Primary|Histologically Measured Bone to Implant Contact (BIC)|Results from morphometric measurements of percentage of new bone in contact with the total surface of the titanium implant, area of new bone and bone graft particles in contact with bone|9 months after implant placement|This was a split-mouth design. Each patient received both treatments. There was one sample in the Straumann BoneCeramic group that could not be analyzed.|||percentage of total surface||Standard Deviation|Mean
1444330|NCT00900822|Secondary|Implant Survival Rate|The percentage of implants remaining in the jaw.|12 months after loading the implant||||percentage of implants|||Number
1444331|NCT00900796|Secondary|Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by ASAS 40 and who received second anti-TNF treatment for at least 16 weeks (Phase 2).|||percentage of participants|||Number
1444332|NCT00900796|Secondary|Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy||Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1444333|NCT00900796|Secondary|Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|ASAS measures symptomatic improvement in ankylosing spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40 percent (%) improvement from baseline and an absolute change of greater than or equal to (>=) 2 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for >= 3 domains, and no worsening in remaining domain.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).|||percentage of participants||95% Confidence Interval|Number
1444334|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator’s criteria.|Week 16|Analysis population included all participants enrolled in study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting first anti-TNF treatment (Phase 1). N (number of participants analyzed) signifies those participants who had low probability of response and were evaluable for the measure.|||percentage of participants||95% Confidence Interval|Number
1444395|NCT00899847|Secondary|Median Time to Engraftment After Allo-PBSC Transplant|"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia"|1 month|Due to the less intensive conditioning before allo-PBSC, only 2 participants experienced cytopenia, and thus only 2 participants could be evaluated for engraftment after allo-PBSC.|||Days||Full Range|Median
1448613|NCT00861601|Secondary|Percent Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|FAS|||Percent change||95% Confidence Interval|Mean
1444335|NCT00900796|Secondary|Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment|Low probability of response = participants who met no more than 2 of 5 criteria at time of treatment start: CRP > 15 mg/L; time from onset of disease less than < 10 years; total spinal pain > 30 mm, measured as mean score on 100 mm VNS (higher score=more severe pain) for nocturnal and total spinal pain; BASDAI > 4 cm, measured as mean score on 10 cm VNS (higher score=more severe state) for discomfort, pain and fatigue; BASFI < 4.5 cm; measured as mean score on 10 cm VNS (higher score=less functionality) evaluating functional capacity. Assessment of response was as per investigator’s criteria.|Week 32|Data was not analyzed as no participant met the criteria for low probability of response in phase 2 of the study.|||percentage of participants||95% Confidence Interval|Number
1444336|NCT00900796|Secondary|Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment|High probability of response=participants who met at least 3 of 5 criteria at start of treatment:C-reactive Protein (CRP) >15 mg/Liter (mg/L);time from onset of disease <10 years;total spinal pain >30 millimeter (mm), mean score on 100 mm visual numeric scale (VNS) for nocturnal, total spinal pain;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 centimeter (cm), mean score on 10 cm VNS for discomfort, pain, fatigue;Bath Ankylosing Spondylitis Functional index (BASFI) <4.5 cm, mean score on 10 cm VNS evaluating functional capacity. Assessment of response was per investigator.|Week 32|Analysis population included all participants with an inadequate response, 16 weeks after starting the first anti-TNF treatment as determined by the investigator and who received second anti-TNF treatment for at least 16 weeks (Phase 2).|||percentage of participants||95% Confidence Interval|Number
1444337|NCT00900796|Primary|Percentage of Participants With a Clinical Response|Assessment of clinical response was as per investigator’s discretion. Investigators were provided with the final consensus document of the Spanish Society for Rheumatology (SER) for the biological treatment of spondyloarthropathies as a guide for defining active AS, the indication of treatment with biological therapy and the assessment of response to it.|Week 16|Analysis population included all participants enrolled in the study who gave their consent, satisfied all evaluation criteria and had information available at Week 16 after starting the first anti-TNF treatment (Phase 1).|||percentage of participants||95% Confidence Interval|Number
1444338|NCT00900757|Secondary|Percentage of Participants With a Osoba Vomiting/Retching Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba vomiting/retching module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba vomiting/retching module is a 5-item questionnaire assessing the effect of vomiting/retching on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all vomiting/retching scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks||||percentage of participants|||Number
1444339|NCT00900757|Secondary|Percentage of Participants With a Osoba Nausea Module Maximum Standardized Score of Zero for Each Week of Radiation (XRT) and Temozolomide (TMZ)|Percentage of participants with a Osoba nausea module maximum standardized score of zero for each week of radiation (XRT) and Temozolomide (TMZ). The Osoba nausea module is a 5-item questionnaire assessing the effect of nausea on quality of life and daily functioning. Raw scores range from 5-20 and have been converted to standardized scores (0-100) using the formula: std_score = round((raw_score - 5) * 6.66). Lower scores indicate better quality fo life. The maximum standardized score of all nausea scores collected during the week (days 1, 3 and 6) was used for this outcome.|6 weeks||||percentage of participants|||Number
1444340|NCT00900757|Secondary|Change in the Functional Living Index - Emesis (FLIE) Score From Baseline to Each Week of Radiation (XRT) and Temozolomide (TMZ) Treatment|The FLIE is a 18-item validated questionnaire for assessing the effects of chemotherapy-induced nausea and emesis on quality of life and daily functioning. The raw score range is 18-126 with higher scores indicating better quality of life. For each week of XRT and TMZ, the change from baseline was calculated by subtracting the baseline score from the mean of the day 1, 3 and 6 scores. A negative change represents worsening in quality of life due to nausea and emesis.|6 weeks||||units on a scale||95% Confidence Interval|Mean
1444341|NCT00900757|Secondary|Complete Response|The percentage of participants with a complete response defined as no emetic episode or use of rescue medication while receiving radiation (XRT) and concomitant temozolomide (TMZ).|6 weeks||||percentage of participants||95% Confidence Interval|Number
1444342|NCT00900757|Primary|Safety and Tolerability of Palonosetron as Determined by the Number of Participants Who Experience Unacceptable Toxicity|The number of participants with unacceptable toxicity defined as ≥grade 3, non-hematologic toxicities that are possibly, probably or definitely related to the study regimen.|6 weeks||||participants|||Number
1444343|NCT00900731|Secondary|Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment|A day with no rescue medication was defined as any day in the diary that the participant used no puffs of rescue medication. The percentage of days with no rescue medication was calculated by dividing the number of days with no rescue medication over the 12 week treatment period by the number of evaluable days and multiplying by 100. Mixed model used baseline percentage of days with no rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Up to 12 weeks|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure.|||Percentage of days||Standard Error|Least Squares Mean
1444344|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning in an electronic diary. The number of nighttime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of nighttime puffs of rescue medication for each participant. Mixed model used baseline number of nighttime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.|||Puffs||Standard Error|Least Squares Mean
1444345|NCT00900731|Secondary|Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each evening in an electronic diary. The number of daytime puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of daytime puffs of rescue medication for each participant. Mixed model used baseline number of daytime puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.|||Puffs||Standard Error|Least Squares Mean
1444346|NCT00900731|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)|Participants recorded the number of puffs of rescue medication taken in the previous 12 hours each morning and evening in an electronic diary. The number of puffs per day over the 12 weeks of treatment was divided by the number of days to derive the mean number per day of puffs of rescue medication for each participant. Mixed model used baseline number of puffs per day of rescue medication, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|Baseline, up to 12 weeks|Full analysis set included all participants who received at least 1 dose of study medication. The endpoint was analyzed only for those participants who had data at baseline and at week 12 for this outcome measure.|||Puffs||Standard Error|Least Squares Mean
1444347|NCT00900731|Secondary|Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment|SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms (frequency and severity), activity (that cause or are limited by breathlessness) and impacts (social functioning & psychological disturbances resulting from airway disease). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.|||Score on a scale||Standard Error|Least Squares Mean
1444348|NCT00900731|Secondary|Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnea index, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|12 weeks|Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure. Missing data were imputed using Last Observation Carried Forward.|||Score on a scale||Standard Error|Least Squares Mean
1444349|NCT00900731|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. FEV1 was measured at 5 and 30 minutes; and 1, 2, and 4 hours post-dose on Week 12. Standardized FEV1 AUC (5 minutes-4 hour) post-dose at week 12 was calculated based on the trapezoidal rule, and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|5 minutes to 4 hours post-dose at the end of treatment (week 12)|Full analysis set included all participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data at week 12 for this outcome measure.|||Liter||Standard Error|Least Squares Mean
1444350|NCT00900731|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.|End of treatment (Week 12)|Per-protocol population included all participants who received at least one dose of study medication without any major protocol deviations. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data were imputed using last observation carried forward.|||Liters||Standard Error|Least Squares Mean
1444351|NCT00900666|Secondary|Gait Function (Based on 6-Minute Walk)|Average walking speed as calculated during a 6-min walk|baseline, 1-mo and 4-mo post-injection|intention to treat|||meters/sec||Standard Deviation|Mean
1444352|NCT00900666|Primary|Mean Peak Knee Flexion During Swing Phase of Gait|Measured via computerized gait analysis, the average of peak knee flexion during swing phase.|baseline, 1-month and 4-month post-injection||||degrees||Standard Deviation|Mean
1444353|NCT00900627|Secondary|Phase II: The Overall Survival (OS) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The time from the date of randomization until the date of death due to any cause.|Weekly visits for routine safety monitoring, accessed up to data cut off on 11th April 2012|Full Analysis Set|||Months|Participants|Inter-Quartile Range|Median
1444396|NCT00899847|Secondary|Median Time to Engraftment After Auto-PBSC Transplant|"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia"|1 month|Includes all study participants|||Days||Full Range|Median
1444923|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
1444354|NCT00900627|Secondary|Phase II: Objective Tumour Response Rate (ORR) Was Compared in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline))|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Evaluable for response set (EFR set is all FAS patients with measureable disease at baseline)|||Participants|||Number
1444355|NCT00900627|Primary|Phase II: Progression-free-survival (PFS) Were Analyzed in Patients Treated With AZD8931 in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression)|Baseline and every 8 weeks, accessed up to data cut off on 11th April 2012|Full Analysis Set|||Months|Participants|Inter-Quartile Range|Median
1444356|NCT00900627|Primary|Phase I: The Number of Dose Limiting Toxicities in AZD8931 in Combination With Weekly Paclitaxel|DLT is an AE or laboratory abnormality related to AZD8931, starting during the DLT evaluation period and meeting any of the following criteria (further detail in protocol): Symptomatic ocular surface lesion; CTCAE grade 4 haematological AE; CTCAE grade ≥3 of febrile neutropenia / neutropenia / thrombocytopenia / hyperkalaemia / hyperglycaemia / hypotension / urological toxicity / ILD / pneumonitis; QTcF interval > 500 msec, two ECGs ≥ 30 minutes apart; Symptomatic congestive cardiac failure and a drop in LVEF; Decrease in LVEF of ≥20% to below the LLN; CS rash remaining CTCAE grade ≥3 for ≥5 days despite optimal treatment; CTCAE grade ≥3 nausea, vomiting or diarrhoea, despite optimal therapy; Other CTCAE grade ≥3 toxicity which, in the opinion of the investigator, is CS and related to AZD8931; Delay to the administration of paclitaxel on D1 of Cycle 2 by ≥7 days. Patients could have more than one DLT.|Weekly visits for routine safety monitoring from Day 1 to Day 28 for each participant|Safety population (all participants who received at least one dose)|||Number of Dose Limiting Toxicities|||Number
1444357|NCT00900601|Secondary|Healing Measured by CT|Number of participants with healing as measured by CT data. The outcome was radiological healing vs no signs of radiological healing. In order to be classified as healed the CT scans had to show Clear signs of bone bridging across the sacroiliac joint.|12 months||||Participants|||Count of Participants
1444358|NCT00900601|Primary|Visual Analogue Scale (VAS) 0 to 10|Visual Analogue Scale is a 0 -10 scale. Zero is no pain and 10 is the worst pain you can imagine. In this study the patients were asked to report the morgning and evening pain by this scale.|12 months||||units on a scale||95% Confidence Interval|Mean
1444359|NCT00900601|Primary|Oswestry Disability Index (ODI)|Oswestry Disability Index is a 10 item questionnaire comprises 10 questions about physical function. Each item has a 0-5 scale and the raw score is multiplied by 2 and the sum is the total score. Zero represents excellent physical function and 100 is more or less bedridden. This is the most used outcome measure in low back pain studies.|12 months||||units on a scale||95% Confidence Interval|Mean
1444360|NCT00900237|Primary|AUC0-t AUC From Time Zero to the Last Sampling Time|AUC0-t - area under the concentration versus time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification CSF - cerebrospinal fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h||||ng.h/mL||Standard Deviation|Mean
1444361|NCT00900237|Primary|Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid|Cmax - Maximum plasma concentration CSF - Cerebral Spinal Fluid Oxcarbazepine, BIA 2-194 and BIA 2-195 are active metabolites of Eslicarbazepine Acetate.|Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h||||ng/mL||Standard Deviation|Mean
1444362|NCT00900159|Secondary|Sleep-dependent Memory Consolidation|A computer-based Word-pair tasks is the number of words recalled after sleep from a list of words shown prior to going to sleep.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts||||words||Standard Deviation|Mean
1444363|NCT00900159|Secondary|Objective Vigilance Task Performance|A computer-based Flanker Task elicits responses to an incongruent pairing of stimuli measured as reaction time, in milliseconds. The Flanker task tests response inhibition, or the participants suppression of an unwanted response. A target stimulus (symbol) is “flanked” by non-target stimuli (symbols) that are the same as the target stimulus, opposite of the target stimulus, or neutral with respect to the target stimulus. The task is intended to assess the ability to maintain “selective attention” in the presence of distractors.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts||||milliseconds||Standard Deviation|Mean
1444364|NCT00900159|Secondary|Subjective Sleepiness and Performance|The Karolinska Sleepiness Scale (KSS), a nine point Visual Analog Scale of alertness/sleepiness, was used to assess subjective sleepiness. The KSS is a scale from 1 to 9, from minimum to maximum sleepiness.|On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts||||units on a scale||Standard Error|Mean
1444365|NCT00900159|Secondary|EEG-recorded Sleep Efficiency|Polysomnographic recordings of daytime sleep were made at sleep screen (8.5hr) and during daytime sleep episodes of 8.5 hours of duration during treatment visits. Sleep efficiency is calculated based on the time the participant spent in bed and the actual time the participant slept.|On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts||||percentage of time sleeping||Standard Deviation|Mean
1444366|NCT00900159|Primary|Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests|Participants underwent four Maintenance of Wakefulness Tests (MWT) at 2-hour intervals during the simulated night shift starting 5 hours after wake time. MWT range from 0 to 40 minutes, where shorter times to fall asleep represent greater sleepiness (worse). MWT tests are averaged, for a mean in minutes.|On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts||||minutes||95% Confidence Interval|Mean
1444368|NCT00900146|Secondary|Percentage Change From Baseline in Fasting Lipids Profile at Month 4 (Period II)|The fasting lipid profiles included triglycerides, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), calculated very low-density lipoprotein (VLDL), non-HDL cholesterol. Percentage change was measured as [(value at month 4 – baseline value)/baseline value]*100%. The analysis of covariance model included treatment and metformin dose group as main effects and baseline triglycerides, total cholesterol, LDL, HDL, VLDL and non-HDL as covariates.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who randomized in error, did not receive study drug. LOCF method was used for patients without Month 4 data for any reason and who used rescue drug or any other glucose lowering agents other than metformin. 'n' = patients with baseline and endpoints data.|||percent change||Standard Error|Least Squares Mean
1444369|NCT00900146|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) at Month 4 (Period II)|The change from baseline in hsCRP (on the logarithmic scale) at Month 4 was measured for this analysis. The analysis of covariance included treatment and metformin dose group as main effects and baseline hsCRP as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||log (mg/L)||Standard Error|Least Squares Mean
1444370|NCT00900146|Secondary|Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI) at Month 4 (Period II)|The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. The score is calculated by the equation: 1 /(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)). In normal subjects, the mean score ± SE is 0.366 ± 0.029. The analysis of covariance included treatment and metformin dose group as main effects and baseline QUICKI as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||units on a scale||Standard Error|Least Squares Mean
1444371|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment Insulin Resistance (HOMA2 IR) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance which is the reciprocal of insulin sensitivity (%S)(100/%S)as a percentage of a normal reference population (normal young adults). The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA2 IR as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||percentage of insulin resistance||Standard Error|Least Squares Mean
1444372|NCT00900146|Secondary|Change From Baseline in Homeostatic Model Assessment B (HOMA2 B) Beta Cell Function (%B) at Month 4 (Period II)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). Time profile of postprandial glucose, insulin and C-peptide were assessed as measures of β-cell response to stimulation. The analysis of covariance included treatment and metformin dose group as main effects and baseline HOMA-B as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||percentage of beta cell function||Standard Error|Least Squares Mean
1444373|NCT00900146|Secondary|Change From Baseline in Fasting Insulin at Month 4 (Period II)|Change in fasting insulin Level measured from blood samples taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting insulin level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/L||Standard Error|Least Squares Mean
1444374|NCT00900146|Secondary|Change From Baseline in Fasting Plasma Glucose at Month 4 (Period II)|Change in Fasting Glucose Level measured from plasma taken at Baseline and at Month 4. The analysis of covariance included treatment and metformin dose group as main effects and baseline fasting plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
1444375|NCT00900146|Secondary|Change From Baseline in Average Plasma Glucose Level (7-point Glucose Testing) at Month 4 (Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: Month 0 (Baseline), Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. Patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline average plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
1448628|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|12 weeks||||participants|||Number
1444376|NCT00900146|Secondary|Change From Baseline in Peak Plasma Glucose Level (7-point Glucose Testing) at Month 4(Period II)|Patients were asked to check their glucose level (7 times) using their glucose meter on one of the seven days prior to the Meal Challenge Visits (Period II: baseline, Month 4. Patient was instructed to test at following timepoints: fasting before breakfast, 2 hours after starting breakfast, before lunch, 2 hours after starting lunch, before dinner, 2 hours after dinner and at bedtime. The patient documented the results in their Study Diary. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak plasma glucose level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
1444377|NCT00900146|Secondary|Change From Baseline in 2 Hour Insulin Secretion Rate Derived Based on Glucose and C-peptide Following at Month 4 Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. A 2 hour insulin secretion rate using deconvolution was performed. The deconvolution was an algorithm that analyzed the insulin secretion rate relative to glucose and C-peptide combined. Blood samples were taken prior to and after meal at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2 hour Insulin secretion rate as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/min/m²||Standard Error|Least Squares Mean
1444378|NCT00900146|Secondary|Change From Baseline in Insulin Secretion Rates Relative to Glucose AUC (0-2 Hours) at Month 4 Following Meal Test (Period II)|Change in Insulin Secretion Rate stimulated by Liquid mixed-meal challenge. A standard liquid mixed-meal challenge was done at baseline and Month 4. Blood samples were taken prior to and after meal for glucose and insulin at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes relative to the start of the meal. The model of analysis of covariance included baseline Insulin secretion rate relative to glucose AUC at 0-2 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/min/m²/mmol *hour/L||Standard Error|Least Squares Mean
1444379|NCT00900146|Secondary|Change From Baseline in Peak Insulin Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour insulin level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol/L||Standard Error|Least Squares Mean
1444380|NCT00900146|Secondary|Change From Baseline in Peak C-peptide Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on the day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak C-peptide level as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||nmol/L||Standard Error|Least Squares Mean
1444381|NCT00900146|Secondary|Change From Baseline in Peak Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline peak glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
1444382|NCT00900146|Secondary|Change From Baseline in 2-hour Glucose Level Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients fasted overnight after 10 pm on day prior to scheduled visit. Study visits should occur before 10 am. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. The sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. The analysis of covariance included treatment and metformin dose group as main effects and baseline 2-hour glucose level as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol/L||Standard Error|Least Squares Mean
1448644|NCT00860470|Secondary|Low Birth Weight|Birth weight below 2500g|December 2014||||participants|||Number
1444383|NCT00900146|Secondary|Change From Baseline in Insulin Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of insulin prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Insulin levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. Model of analysis of covariance included baseline insulin AUC 0-4 hours as covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||pmol*hour/L||Standard Error|Least Squares Mean
1444384|NCT00900146|Secondary|Change From Baseline in Prandial Plasma Glucose Area Under Curve (AUC0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of glucose prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to the start of meal. Glucose levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The model of analysis of covariance included baseline plasma glucose AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||mmol*hour/L||Standard Error|Least Squares Mean
1444385|NCT00900146|Secondary|Change From Baseline in C-peptide Area Under Curve (AUC 0-4 Hours ) Following Meal Test (Period II)|A standard liquid mixed-meal challenge was done at baseline and Month 4. Patients completed each standard meal challenge with measurement of C-peptide prior to and after a liquid mixed meal. Sampling times were -20, -10, and -1, 10, 20, 30, 60, 90, 120, 150, 180 and 240 minutes relative to start of meal. C-peptide levels over 4 hrs were shown as Area Under the Curve,(AUC). AUC was calculated as: x=1 AUC ΣAx n Where Ax = AUC for the 240 min.interval, and X = 1 for the 1st interval. The analysis of covariance included baseline C-peptide AUC 0-4 hours as a covariate.|Baseline, Month 4|The full analysis set included all randomized patients except for mis-randomized patients who inadvertently randomized into study and did not receive study drug. Last observation carried forward method was used for patients without Month 4 data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||nmol*hour/L||Standard Error|Least Squares Mean
1444386|NCT00900146|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II)|HbA1c was measured by National glycohemoglobin standardization program (NGSP) certified methodology. HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. The analysis of covariance (ANCOVA) included treatment and metformin dose group as main effects and baseline HbA1c as a covariate.|Baseline, Month 4|The full analysis set (included all randomized patients except for mis-randomized patients who randomized in error but did not receive study drug. Last observation carried forward (LOCF) method was used for patients without Month 4 HbA1c data for any reason and who used rescue medication or any other glucose lowering agents other than metformin.|||percentage of hemoglobin A1c||Standard Error|Least Squares Mean
1444387|NCT00900146|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II)|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|4 months (Period II)|The safety set (SAF) included all patients who received at least one dose of study medication during Period II.|||Participants|||Number
1444388|NCT00900029|Primary|Number of Subjects With Target Wound Closed for the First Time During the Study Period.|At each visit the status of open target ulcers was evaluated as “remained open” or “closed”.|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.|||participants|||Number
1444389|NCT00900029|Primary|The Number of Participants With Closed Target Ulcers at Each Visit|At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.|Over the 24-week study period, at each of the bi-monthly visits|Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.|||participants|||Number
1444390|NCT00899847|Secondary|Overall Survival (OS)|To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS)|2 years after the last participant is enrolled|Includes all study participants|||percentage of participants||95% Confidence Interval|Number
1444391|NCT00899847|Secondary|Event-free Survival (EFS)|To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS)|2 years after the last participant is enrolled|Includes all study participants|||percentage of participants||95% Confidence Interval|Number
1444392|NCT00899847|Secondary|Partial Response Rate (PRR)|"Partial response rate (PRR) was assessed as~> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr~If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain~If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma."|1 year|Includes all study participants|||Participants|||Count of Participants
1444393|NCT00899847|Secondary|Complete Response Rate (CRR)|"Complete response rate (CRR) was assessed as all of:~Negative immunoflixation on the serum and urine~Disappearance of any soft tissue plasmacytomas~< 5% plasma cells in bone marrow"|1 year|Includes all study participants|||Participants|||Count of Participants
1444394|NCT00899847|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR)|1 year|Includes all study participants|||Participants|||Count of Participants
1444397|NCT00899847|Primary|Incidence of Graft Versus Host Disease (GvHD)|To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting|2 years after the last participant is enrolled.|Due to the significance of the allo-PBSC transplant as a component to the treatment plan, participants who did not receive allo-PBSC are not included.|||Participants|||Count of Participants
1444398|NCT00899717|Secondary|Condylar Path Angles|Parasagittal plane condylar path angles tracings in relation to the Frankfort line were made following the Gysi extraoral method.|Baseline||||degrees||Standard Deviation|Mean
1444399|NCT00899717|Secondary|Maximum Mouth Opening (mm)|Maximum voluntary unassisted mouth opening|6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up||||mm||Standard Deviation|Mean
1444400|NCT00899717|Secondary|Preferred Chewing Side|The change in the habitual chewing side of each participant across the study|Before and 6 months after therapy||||participants|||Number
1444401|NCT00899717|Secondary|Symptom Checklist-90-Revised (SCL-90-R®)|Scale name: Global Severity Index. Scale graded from 0 to 4. Scores increases as the symptoms severity increases.|Before and 6 months after therapy|Only tests from 15 participants were suitable because of slow or too many positive responses.|||units on a scale||Standard Deviation|Mean
1444402|NCT00899717|Primary|Visual Analogic Scale for Pain Intensity (0-10)|"The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0=No pain and 10=Worst imaginable pain"|Baseline, immediately after therapy, 3 months and 6 months after therapy||||units on a scale||Standard Deviation|Mean
1444403|NCT00899678|Secondary|Percentage of Subjects in Corticosteroid-free Remission at the End of the Study|Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn’s Disease Activity index (PCDAI) data is available.|Last/Withdrawal Visit (up to Week 62)|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.|||percentage of paticipants||95% Confidence Interval|Number
1444404|NCT00899678|Secondary|Percentage of Subjects Who Initiated Steroid Tapering|Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject’s dose.|From Week 2 up to Week 8|Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.|||percentage of subjects||95% Confidence Interval|Number
1444405|NCT00899678|Secondary|Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)|The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.|From Week 0 to Week 62|Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores.|||participants|||Number
1444406|NCT00899678|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)|"The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn’s Disease (CD).~Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).|||ratio||95% Confidence Interval|Geometric Mean
1444407|NCT00899678|Secondary|Erythrocyte Sedimentation Rate (ESR) at Week 62|The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn’s Disease (CD).|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).|||mm/h||95% Confidence Interval|Geometric Mean
1444408|NCT00899678|Secondary|Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)|"The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn’s Disease (CD).~Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.|||ratio||95% Confidence Interval|Geometric Mean
1444409|NCT00899678|Secondary|C-Reactive Protein (CRP) Levels at Week 62|The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn’s Disease (CD)|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.|||mg/L||95% Confidence Interval|Geometric Mean
1444410|NCT00899678|Secondary|Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)|"Clinical response is defined as a decrease from Week 0 in Pediatric Crohn’s Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points.~The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|From Week 0 to Week 62|Full Analysis Set (FAS) population|||percentage of participants||95% Confidence Interval|Number
1444481|NCT00897676|Primary|Area Under the Curve (AUC) Plasma Glucose|Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion|Time 0 min - time 360 min|A total of 16 subjects were included in the analysis. 1 subject was withdrawn.|||mg*min/dL||Standard Deviation|Mean
1448645|NCT00860470|Secondary|Moderate to Late Preterm|Risk of birth between 32 and 37 weeks gestation|December 2014||||participants|||Number
1444411|NCT00899678|Secondary|Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)|"The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.~A negative value in change from Baseline indicates an improvement from Baseline to Week 62."|From Week 0 to Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.|||units on a scale||Standard Deviation|Mean
1444412|NCT00899678|Secondary|Absolute Pediatric Crohn’s Disease Activity Index (PCDAI) Scores at Week 62|The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.|Week 62|Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.|||Score on a scale||Standard Deviation|Mean
1444413|NCT00899678|Primary|Percentage of Subjects in Clinical Remission at Week 62|"Clinical remission is defined as a Pediatric Crohn’s Disease Activity Index (PCDAI) score ≤ 10.~The Pediatric Crohn’s Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity."|Week 62|Full Analysis Set (FAS) population|||percentage of participants||95% Confidence Interval|Number
1444414|NCT00899600|Secondary|Complications Related to Ketamine||24 and 48 hours|||||||
1444415|NCT00899600|Secondary|Hemodynamic Changes||24 and 48 hours|||||||
1444416|NCT00899600|Secondary|Mortality||1 year|||||||
1444417|NCT00899600|Secondary|Hospital Duration||24 and 48 hours|||||||
1444418|NCT00899600|Primary|Morphine Consumption in the First 48 Hours After Surgery|Total morphine(mg)consumed at 48 hours.|48 hours|See methodology|||mg||Standard Deviation|Mean
1444419|NCT00899574|Secondary|Clinical Benefits|This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.|||patients|||Number
1444420|NCT00899574|Primary|Objective Response (Complete Clinical Response+ Partial Response)|This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.|9 weeks|Patients who completed 1 cycle of treatment (8 weeks) and response evaluation at week 9.|||percentage of patients||95% Confidence Interval|Number
1444421|NCT00899470|Secondary|Number of Participant With Clinically Relevant Physical Examination Abnormalities|A physical examination was conducted which included height and weight measurements, from which the Body Mass Index was determined. Physical examination abnormalities were judged to be of medical importance by the Investigator.|Screen, Period 1 Day -1, prior to discharge|All Treated Participants|||participants|||Number
1444422|NCT00899470|Secondary|Number of Participants With Clinically Relevant Vital Sign Abnormalities|Mean systolic and diastolic blood pressure, heart rate, respiration, and temperature were assessed.Vital sign abnormalities abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants|||participants|||Number
1444423|NCT00899470|Secondary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities|PR interval, QRS complex, width of QRS, QT interval, and QT corrected for heart rate adjusting for heart rate using either Bazett formula or Fridericia formula were measured. ECG abnormalities were judged to be of medical importance by the Investigator.|Period 1 Day 1, Period 2 Day 1, Period 3 Day 1, Period 4 Day 1, Period 4 Day 3|All Treated Participants|||participants|||Number
1444424|NCT00899470|Secondary|Number of Participants With Laboratory Marked Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Leukocytes: <0.9 x LLN/ >1.2 x ULN; blood urea nitrogen (BUN): >1.1 x ULN; creatinine: >1.33 x BL; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN; creatinine kinase (CK): >1.5 x ULN; urine blood=use ≥2 x BL if value ≥2+ or BL1+|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants|||participants|||Number
1444425|NCT00899470|Secondary|Number of Participants With at Least 1 Adverse Event (AE), Death, Serious AE (SAE), or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 1 through Day 45, including up to 56 days after last dose of study medication|All Treated Participants|||participants|||Number
1444426|NCT00899470|Secondary|BMS-510849 Mean T-half and T-max|T-half and Tmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administerd as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||hours||Standard Deviation|Mean
1444924|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
1444427|NCT00899470|Secondary|BMS-510849 Mean AUC (0-INF)|AUC (0-T)= for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
1444428|NCT00899470|Secondary|BMS-510849 Mean AUC (0-T)|AUC (0-T) for the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administration as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
1444429|NCT00899470|Secondary|BMS-510849 Mean Cmax|Cmax of the saxagliptin metabolite BMS-510849, following single-dose saxagliptin (2.5 mg) coadministered with metformin IR (500 mg) or administered as an FDC 2.5 mg saxagliptin/500 mg metformin IR tablet, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng/mL||Standard Deviation|Mean
1444430|NCT00899470|Primary|Metformin T-half and T-max|T-half and T-max for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg), or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||hours||Standard Deviation|Mean
1444431|NCT00899470|Primary|Metformin Mean AUC(0-INF)|AUC (0-INF) for single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
1444432|NCT00899470|Primary|Metformin Mean AUC (0-T)|AUC (0-T for single-dose metformin (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
1444433|NCT00899470|Primary|Metformin Mean Cmax|Cmax of single-dose metformin IR (500 mg), either coadministered with saxagliptin (2.5 mg) or administerd as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng/mL||Standard Deviation|Mean
1444434|NCT00899470|Primary|Saxagliptin Mean Plasma Half-life (T-half) and Mean Time of Maximum Observed Plasma Concentration (T-max)|T-half and T-max for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg) or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||hours||Standard Deviation|Mean
1444435|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Infinity (AUC [0-INF])|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
1444436|NCT00899470|Primary|Saxagliptin Mean Area Under the Plasma Concentration Time Curve From Time Zero To Time of Last Quantifiable Concentration (AUC [0-T]}|AUC (0-T) for single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng*h/mL||Standard Deviation|Mean
1444437|NCT00899470|Primary|Saxagliptin Mean Maximum Observed Plasma Concentration (Cmax)|Cmax of single-dose saxagliptin (2.5 mg), either coadministered with metformin IR (500 mg), or administered as FDC 2.5 mg saxagliptin/500 mg metformin IR, under fasted and fed conditions.|Day 1: 0 hr, 0.25 hr, 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, 18 hr, Day 2: 0 hr, 12 hr, Day 3: 0 hr|PK data set, all participants who received study drug|||ng/mL||Standard Deviation|Mean
1444438|NCT00899392|Secondary|GI Suite Flow Efficiency Measured in 15 Minute Increments||At completion of study|||||||
1444439|NCT00899392|Secondary|Questions Asked by Subjects (Parents)|Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.|Questions written by parents during the end of consent process (48-72 hours)||||Questions||Full Range|Mean
1444440|NCT00899392|Secondary|Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)|s-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.|12-18 hours (Night before Endoscopy to Day of Endoscopy)|Matched pairs (pre consent and post consent), Pilot data included to increase power analysis|||Units on a Scale (STAI Score)||Standard Deviation|Mean
1444441|NCT00899392|Secondary|Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)|Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.|Every 1-2 months|(Consent Group + some pilot participants to increase power of analysis)|||Units on a scale||Standard Deviation|Mean
1444499|NCT00897390|Primary|Saxagliptin PK Parameter Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC[0-T])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
1444442|NCT00899392|Primary|Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)|"Units on a scale (score) as Measured by Consent 20 Instrument.~20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points.~Measures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40"|Every 1-2 months||||Units on a scale||Standard Deviation|Mean
1444443|NCT00899379|Secondary|Pain Relief at 2 Hours During the Fourth Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.|||Participants|||Number
1444444|NCT00899379|Secondary|Pain Relief at 2 Hours During the Third Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.|||Participants|||Number
1444445|NCT00899379|Secondary|Pain Relief at 2 Hours During the Second Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack|2 hours|The secondary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase. Values were not carried forward from one attack period to the next.|||Participants|||Number
1444446|NCT00899379|Primary|Pain Relief at 2 Hours During the First Migraine Attack Period|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack|2 hours|The primary efficacy analysis used an all-patients-treated approach which included all patients who had at least one record of an efficacy measure after the initial dose. Missing values were imputed by carrying forward the preceding values in the same phase.|||participants|||Number
1444447|NCT00899353|Primary|The Degree of Change in Tumor Mass Measurements During and After Omega-3 Supplementation as Evaluated by Standard Clinical Tests of Disease Activity.|"Patients diagnosed with early stage (asymptomatic) CLL were supplemented with escalating doses of omega-3 (n-3) fatty acids (2.4 g of n-3/day up to 7.2 g of n-3/day). Given that these patients are asymptomatic and did not require treatment, measures of tumor mass during and after omega-3 supplementation, as evaluated by standard clinical tests of disease activity, were not performed. Instead, absolute lymphocyte counts (ALC), as a measure of tumor burden, was evaluated before and after omega-3 supplementation. Data represents the fold change in ALC post omega-3 consumption as compared to baseline ALC.~Patients with MGUS or SMM were not enrolled into this study."|Baseline, month 1, month 2, month 3, month 6, month 9, 12 months|Patients who's absolute lymphocyte counts were known prior to omega-3 initiation (baseline) and after omega-3 consumption were included in this analysis. Patients who's ALC was unknown prior to omega-3 initiation or after omega-3 consumption were excluded.|||Fold Change|||Number
1444448|NCT00899353|Primary|Activated Nuclear Factor Kappa B (NFkB) in Peripheral Blood Lymphocytes From Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) Before, During and After Consumption of an Omega 3 Supplement.|Peripheral lymphocytes were isolated from the blood using Ficoll-Paque gradient. Nuclear Factor Kappa B activation was analyzed using Thermo Scientific Transcription Factor kit for NFkB p50, according to manufacturer’s protocol. Protein extracts containing 1-15µg of protein/well were added in triplicates. Luminescence resulting from a reaction with bound NFkB was detected using a Berthold Centro LB960 Luminometer and analyzed with MikroWin 2000 ver. 1.08. NFkB activity was normalized by luminescence units/µg of protein per well.|baseline, and post supplement month 1(3 capsules/day), month 2 (6capsules/day), month 3 (9 capusules/day), month 6 (9 capusules/day), month 9 (9 capusules/day), month 12 (post supplement)|NFkB activation of all patients diagnosed with early stage CLL at baseline and following omega 3 consumption. Patients are further separated into high (> median, n=7) and low initial baseline (< median, n=6) NFkB. Patients included must have had one baseline and at least one period of omega 3 consumption. Not all patients completed all periods|||10^6 NFkB Luminescence units/µg protein||Standard Error|Mean
1444449|NCT00898937|Primary|Tumor Gene Expression as Assessed by RNA Microarray Analysis|Concentration of RNA recovered from breast needle biopsies|1 day||||micrograms||Standard Error|Mean
1444450|NCT00898807|Secondary|Neuropsychiatric Inventory (NPI)-- Agitation Subscore|NPI agitation score is based on responses from an informed caregiver involved in the patient's life. Symptom severity (1=mild, 2=moderate, 3=severe) is multiplied by frequency (1=occasionally, less than once/week; 4 = very frequently, once or more/day or continuously) to obtain the NPI agitation score.Range is 0-12. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."|||units on a scale||Standard Deviation|Mean
1444451|NCT00898807|Secondary|Cohen-Mansfield Agitation Inventory (CMAI)|CMAI examines several agitated behaviors including verbal, physical agitation, and other behaviors. Sub-items are summed. Range is 14-70. Higher scores indicate more severe symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 169 of the 186 patients had week 9 data."|||units on a scale||Standard Deviation|Mean
1444500|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(INF)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
1444452|NCT00898807|Primary|Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in Agitation(CGIC)|Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change in agitation(CGIC) accesses clinically significant change in agitation. A trained clinician, blind to treatment assignment, uses a 7-point Likert scale to rate change of each patient along a continuum from “marked improvement”(1), “no change”(4), and “marked worsening”(7). A number of aspects of the agitation is considered such as emotional agitation, mood liability/distress, psychomotor agitation, verbal aggression, and physical aggression. Range is 1-7.|Baseline to 9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on CGIC."|||percentage moderate/marked improvement|||Number
1444453|NCT00898807|Primary|NeuroBehavior Rating Scale-- Agitation|NeuroBehavioral Rating Scale- Agitation(NBRS-A) assesses multiple types of psychopathology common in dementia and is based on a seven point Likert scale of increasing severity for each item(i.e., 0=not present, 1=very mild, 2-mild, 3=moderate, 4=moderately severe, 5=severe, 6=extremely severe). The NBRS agitation subscore includes NBRS 'inhibition’, ‘agitation’, and ‘hostility’. The range is 0 to 18 points. Higher scores indicate more symptoms.|9 weeks|"The primary analysis was an intention-to-treat analysis; analysis was conducted as randomized. Data from the 186 randomized participants were used in the analytic model. 167 of the 186 patients had week 9 data on the NBRS."|||units on a scale||Standard Error|Mean
1444454|NCT00898677|Secondary|Nausea at 2 Hours After Dose|Patients who recorded the presence or absence of nausea 2 hours after dose|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||participants|||Number
1444455|NCT00898677|Secondary|Functional Status at 2 Hours After Dose|Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444456|NCT00898677|Secondary|Pain Free at 2 Hours After Dose|Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after dose|An “all-patients-treated” approach was used in the secondary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.|||Participants|||Number
1444457|NCT00898677|Primary|Time to Relief Within 2 Hours After Dose|Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose|within 2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication.|||Participants|||Number
1444458|NCT00898677|Primary|Pain Relief at 2 Hours After Dose|Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after dose|An “all-patients-treated” approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.|||Participants|||Number
1444459|NCT00898560|Secondary|AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day||||ng.h/mL||Standard Deviation|Mean
1444460|NCT00898560|Secondary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day||||ng.h/mL||Standard Deviation|Mean
1444461|NCT00898560|Primary|Cmax - Maximum Observed Plasma Concentration|To investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).|15-day||||pg/mL||Standard Deviation|Mean
1444462|NCT00898443|Secondary|Impact of Anesthesia Type on OR (Operating Room) Efficiency|The time minutes)from initiation of anesthesia to surgery start.|minutes until surgery start|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.|||minutes||Full Range|Median
1444463|NCT00898443|Primary|Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation|Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.)|at the time of surgery|Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.|||participants|||Number
1444464|NCT00898222|Primary|Change in Exhaled Inflammatory Mediator Levels|Descriptive statistics|baseline and 6 months||||pg/mL||Full Range|Mean
1444482|NCT00897390|Secondary|Electrocardiogram (ECG), Vital Sign, and Physical Finding Abnormalities|12-lead Electrocardiogram (ECG), Vital Sign (body temperature, respiratory rate, seated blood pressure and heart rate), and Physical Finding Abnormalities reported by investigator as AEs.|At Screening (within 21 days of Study Day 1), Day -1 of Period 1 (ECG and Physical only), Day 1 of Periods 1-4 (Vitals only), at Study Discharge (Day 3 of Period 4) or Discontinuation|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.|||participants|||Number
1444465|NCT00897949|Secondary|Pain Relief 2 Hours After Treatment for Headache Recurrence|Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours).|2 hours after treatment for recurrence|Patients with initial headache recurrence who took rizatriptan 5 mg or 10 mg were prerandomized (ratio=1:1) to either rizatriptan 5 mg or 10 mg, respectively, or to placebo (ratio=1:1); and who took placebo, to either 5 mg or 10 mg of rizatriptan (ratio=1:1). Only those who took rizatriptan for their initial headache were considered for analysis.|||Participants|||Number
1444466|NCT00897949|Secondary|Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug||2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444467|NCT00897949|Secondary|No Disability at 2 Hours After the Initial Dose of Test Drug|Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 – Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of functional disability within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444468|NCT00897949|Secondary|Pain Free at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|An “all-patients-treated” approach was employed that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444469|NCT00897949|Primary|Pain Relief at 2 Hours After the Initial Dose of Test Drug|Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain.|2 hours after initial dose of test drug|The primary analysis employed an “all-patients-treated” approach that included all patients who had at least one record of pain severity within 2 hours after the initial dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444470|NCT00897910|Secondary|Cell Counts of Myeloma-specific T Cells ex Vivo Expanded Before and After CD3/CD28 Stimulation||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.|||||||
1444471|NCT00897910|Primary|Percentage of Myeloma-specific T Cells ex Vivo Expanded Using Flow Cytometry||Collection of PBMCs over a period of 9-12 months, and the laboratory component will be performed over another year.|||||||
1444472|NCT00897897|Secondary|Fibroid Symptom Severity Score (SSS) From the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) Questionnaire.|"Mean absolute change in the Symptom Severity Score (SSS) of the Uterine Fibroid Symptoms - Quality of Life (UFS-QoL) questionnaire after fibroid treatment with HIFU.~The SSS is a scale from 0-100, where 0 corresponds to no symptoms and 100 corresponds to the most severe symptoms."|At baseline and at 30 days following treatment||||scores on a scale||Standard Deviation|Mean
1444473|NCT00897897|Primary|Adverse Events/Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of Adverse Events reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of Adverse Events per subject.|30 days after treatment||||Adverse Event/subject||Standard Deviation|Mean
1444474|NCT00897715|Secondary|Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks|IL-6 is a sensitive laboratory assay for serum levels of Interleukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville|||pg/ml||Inter-Quartile Range|Median
1444475|NCT00897715|Primary|Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks|hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation|baseline and 12 weeks|The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville.|||mg/dl||Inter-Quartile Range|Median
1444476|NCT00897676|Secondary|Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1)|Area under the curve plasma active GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 min to time 360 min||||pmol*min/L||Standard Deviation|Mean
1444477|NCT00897676|Secondary|Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1)|Area under the curve plasma total GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 to time 360 min||||pmol*min/L||Standard Deviation|Mean
1444478|NCT00897676|Secondary|Area Under the Curve (AUC) Plasma Glucagon|Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 min to time 360 min||||pg*min/mL||Standard Deviation|Mean
1444479|NCT00897676|Secondary|Area Under the Curve (AUC) Plasma C-peptide|Area under the curve plasma C-peptide from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion|time 0 min to time 360 min||||ng*min/mL||Standard Deviation|Mean
1444480|NCT00897676|Secondary|Area Under the Curve (AUC) Plasma Insulin|Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion|time 0 min to time 360 min|data from only 15 subjects because the values were below the level of detection for one subject.|||uIU*min/mL||Standard Deviation|Mean
1444483|NCT00897390|Secondary|Number of Participants With Marked Urinalysis Abnormalities|Protein, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Glucose, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). Blood, Urine Abnormality: if value >= 2+ (or if pretreatment value >= 1+, then >= 2 * pretreatment). White Blood Cell (WBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). Red Blood Cell (RBC), Urine Abnormality: if value >= 2+ (or if pretreatment value >= 2+, then >= 4+). (The '+' is a normal lab result and refers to the magnitude of the finding.)|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Number of Participants Analyzed=treated participants; n=number of participants evaluated for this measure (among the 6 participants who had the urinary WBC and RBC test, there are only 2 had a pre-study evaluation, and were therefore evaluable for these measures.|||participants|||Number
1444484|NCT00897390|Secondary|Number of Participants With Marked Laboratory Abnormalities (MA)|Laboratory abnormalities=any result that is clinically significant, met the definition of an SAE, required discontinuation or interruption of study drug, or required specific corrective therapy. Upper normal (UN)/lower normal (LN) values: leukocytes UN, 11.40x10^3 c/uL; absolute neutrophils/bands LN, 1.500x10^3 c/uL; aspartate aminotransferase UN, 48 U/L; alanine aminotransferase UN, 67 U/L; blood urea nitrogen UN, 20.0 mg/dL; creatine kinase UN, 350 U/L; lactate dehydrogenase UN, 249 U/L.|Within 21 days of study Day 1, Days 1-3 of Periods 1, 2, 3, and 4.|Treated participants. One participant each in Arm C and Arm D was not evaluated for this measure.|||participants|||Number
1444485|NCT00897390|Secondary|AEs of Special Interest|See Outcome Measure 16 for a definition of AEs. AEs of clinical interest for saxagliptin were defined as those relating to the following:skin disorders, infection-related AEs (system organ class [SOC]: Infections and Infestations), thrombocytopenia, lymphopenia, hypoglycemia, cardiovascular AEs indicative of acute cardiovascular events, localized edema, fractures, pancreatitis, and AEs of hypersensitivity.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days).|All treated participants|||participants|||Number
1444486|NCT00897390|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs|An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|AEs collected from Day 1/Period 1 through study discharge (study duration: approximately 45 days). SAEs collected from date of written consent until 30 days post discontinuation of dosing or subject’s participation in the study.|All treated participants|||participants|||Number
1444487|NCT00897390|Secondary|BMS-510849 PK Parameter T-Max|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Full Range|Median
1444488|NCT00897390|Secondary|BMS-510849 PK Parameter T-Half|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from their respective plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Standard Deviation|Mean
1444489|NCT00897390|Secondary|BMS-510849 PK Parameter Cmax|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng/mL||Full Range|Geometric Mean
1444490|NCT00897390|Secondary|BMS-510849 PK Parameter AUC(0-T)|Single-dose PK parameters of the active metabolite of saxagliptin, BMS-510849, were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
1444491|NCT00897390|Primary|Metformin PK Parameter Tmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Full Range|Median
1444492|NCT00897390|Primary|Metformin PK Parameter T-HALF|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Standard Deviation|Mean
1444493|NCT00897390|Primary|Metformin PK Parameter Cmax|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng/mL||Full Range|Geometric Mean
1444494|NCT00897390|Primary|Metformin PK Parameter AUC(0-T)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
1444495|NCT00897390|Primary|Metformin PK Parameter AUC(INF)|Single-dose PK parameters of metformin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
1444496|NCT00897390|Primary|Saxagliptin PK Parameter Time of Maximum Observed Plasma Concentration (Tmax)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Full Range|Median
1444497|NCT00897390|Primary|Saxagliptin PK Parameter Plasma Terminal Half-life (T-HALF)|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||hours||Standard Deviation|Mean
1444925|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)|12 hours|Safety population|||L/min||Full Range|Mean
1444501|NCT00897390|Primary|Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])|Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.|pre-dose, post-dose at 15, 30, 45, 90 minutes, hours 1, 2, 3, 4, 6, 8, 12, 18, 24, 36 and 48 of each period|Treated participants with PK measures|||ng*h/mL||Full Range|Geometric Mean
1444502|NCT00897104|Secondary|Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1])|Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence|24 hours|The duration of relief, or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1), was calculated for responders who had a headache recurrence.|||Hours||Standard Deviation|Mean
1444503|NCT00897104|Secondary|Participants Who Used Escape Medication 2 Hours After the Treatment Dose|Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444504|NCT00897104|Secondary|Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment|Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.|2 hours after treatment|“All-participants-treated” approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories.|||Participants|||Number
1444505|NCT00897104|Secondary|Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities|Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444506|NCT00897104|Secondary|Pain Free at 2 Hours After Treatment|Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).|2 hours after treatment|An “all-participants-treated” approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444507|NCT00897104|Primary|Time to Relief Within 2 Hours After Treatment|Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).|within 2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication.|||Participants|||Number
1444508|NCT00897104|Primary|Pain Relief at 2 Hours After Treatment|Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment|2 hours after treatment|An “all-participants-treated” approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value.|||Participants|||Number
1444509|NCT00896779|Primary|Mean Change in Visual Acuity|Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported.|12 months||||letters||Standard Deviation|Mean
1444510|NCT00896649|Secondary|Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study|Number of participants satisfied with positron emission mammography with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied.|One month|All participants who completed imaging and questionnaires.|||participants|||Number
1444511|NCT00896649|Primary|"Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 in Positron Emission Mammography"|"Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) 0 in positron emission mammography~Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale:~0 = Inconclusive for malignancy; call-back in mammography~= normal~= abnormal, with no malignancy~= abnormal, likely benign~= abnormal, likely malignant~= malignant"|immediately at completion of mammogram|Number of participants who completed protocol with complete data set|||participants|||Number
1444512|NCT00896454|Secondary|Change From Baseline in Corrected Serum Calcium||Baseline and Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Efficacy Analysis Subset included all participants who received at least 1 dose of denosumab. n = Number of participants who had non-missing data at Baseline and the time point of interest.|||mmol/L||Inter-Quartile Range|Median
1444513|NCT00896454|Secondary|Time to Relapse/Nonresponse of Hypercalcemia of Malignancy|Time to relapse/nonresponse was defined as the number of days from study Day 1 until the last day of CSC ≤ 11.5 mg/dL for all particiipants with relapse after the first response. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after first response. For participants who never achieved response, time to relapse/nonresponse was set to zero. Otherwise, if there was no post-baseline CSC assessment, time to relapse/nonresponse was censored on study Day 1. Time to relapse/nonresponse was estimated using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset|||days||95% Confidence Interval|Median
1444926|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)|12 hours|Safety population|||Ratio||Full Range|Mean
1444514|NCT00896454|Secondary|Duration of Complete Response|Duration of complete response is defined as the number of days from the first day of of corrected serum calcium ≤ 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium ≤ 10.8 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 10.8 mg/dL after the complete response. If a participant had no CSC assessment after the complete response, duration of complete response was set to zero and censored. Duration of complete response was summarized for participants who achieved a complete response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a complete response in the Response Analysis Subset|||days||95% Confidence Interval|Median
1444515|NCT00896454|Secondary|Duration of Response|Duration of response is defined as the number of days from the first day of corrected serum calcium ≤ 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if their CSC level never reached > 11.5 mg/dL after the first response. If a participant had no CSC assessment after the first response, duration of response was set to zero and censored. Duration of response was summarized for participants who achieved a response using the Kaplan-Meier method.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Participants with a response in the Response Analysis Subset|||days||95% Confidence Interval|Median
1444516|NCT00896454|Secondary|Time to Complete Response|Time to complete response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) was ≤ 10.8 mg/dL (2.7 mmol/L). Participants were censored on the last CSC assessment day if no complete response was observed. If there was no post-baseline CSC assessment, time to complete response was censored on study Day 1. Time to complete response was analyzed using Kaplan–Meier methods.|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset|||days||95% Confidence Interval|Median
1444517|NCT00896454|Secondary|Time to Response|"Time to Response was defined as the time period from study Day 1 to the first time post-baseline corrected serum calcium (CSC) ≤ 11.5 mg/dL. Participants were censored on the last CSC assessment day if no response was observed. If there was no post-baseline CSC assessment, time to response was censored on study Day 1.~Time to response was analyzed using Kaplan–Meier methods."|From Day 1 until the end of study date or primary data cutoff date (13 September 2012), whichever occured first; median time on study was 1.8 months.|Response Analysis Subset|||days||95% Confidence Interval|Median
1444518|NCT00896454|Secondary|Percentage of Participants With a Complete Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 10.8 mg/dL (2.7 mmol/L). For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL])).|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset|||percentage of participants||95% Confidence Interval|Number
1444519|NCT00896454|Secondary|Percentage of Participants With a Response by Visit|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))|Days 2, 4, 8, 10, 15, 19, 23, 29, 36, 43, 50 and 57|Response Analysis Subset|||percentage of participants||95% Confidence Interval|Number
1444520|NCT00896454|Primary|Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab|Response is defined as corrected serum calcium (CSC) ≤ 11.5 mg/dL, within 10 days after the first dose of denosumab. For all CSC values, if albumin was < 4 g/dL, the following formula was used to calculate CSC: CSC = Total serum calcium [mg/dL] + (0.8 x (4 – serum albumin [g/dL]))|10 days|Response Analysis Subset including all participants who received at least 1 dose of denosumab and had a screening CSC (from local lab) > 12.5 mg/dL (3.1 mmol/L).|||percentage of participants||95% Confidence Interval|Number
1444521|NCT00896441|Secondary|Hamilton Anxiety Scale|Hamilton Anxiety Scale (HAMA) was utilized. Scores range from 0-56, with higher scores indicating more anxiety. The change score utilized baseline and Day 56 (week 8) scores. The change scores was HAMA day 1 less Ham A day 56 / HAMA Day 1. Thus, larger numbers equal a greater reduction in anxiety.|% change in anxiety from Day 1 to Day 56 (week 8)|Only participants completing the protocol are included in the analysis. Only participants in the Depressed group were analyzed for change in anxiety symptoms.|||percentage of change in anxiety||Standard Deviation|Mean
1444522|NCT00896441|Primary|Voxel-wise Changes in Resting State Functional Connectivity to the Posterior Cingulate Cortex|The dependent variable, measured in more than 30,000 voxels across the whole brain, was the functional connectivity between the posterior cingulate cortex seed region and each voxel. This is derived as the correlation coefficient between the blood-oxygen-level dependent (BOLD) signal timeseries in the seed region and the BOLD signal timeseries in each voxel.|baseline and week 8|Owing to the limited sample size, we first examined this measure in the depressed subjects using a paired-sample t-test at each of the 30,000+ voxels. No significant voxels were detected in this analysis and so subsequent analyses combining the depressed subjects and the healthy control subjects in a single model were not performed.|||significant voxels|||Number
1444523|NCT00896441|Primary|Hamilton Depression Rating Scale Percent Change From Day 0 to D56|Utilized the Hamilton Depression Rating Scale (HAM), 21-item version to assess depressive symptoms, with a range of 0-63. Higher scores indicate more depression. For the change score, it is Baseline less Day 56 HAM total / Baseline. Thus, larger values mean a greater decrease in the level of depression|% change from baseline to Day 56 ( week 8)|Only participants completing the protocol are included in the analysis; thus, the N = 12. Only participants in the Depressed group were analyzed for change in depressive symptoms.|||percentage of change in depression||Standard Deviation|Mean
1444524|NCT00896389|Secondary|Change in Plasma Sodium/Potassium Level During High Dose of HCTZ|Na/K ratio is a function of kidney function|Plasma sodium and potassium measured from blood collected pre and post salt loading|25 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ratio||Standard Error|Mean
1444927|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)|12 hours|Safety population|||% predicted||Full Range|Mean
1444525|NCT00896389|Primary|Fasting Glucose Change After 7 Days of High Dose (25mg) of HCTZ|Values on Day 8 subtracts Day 0.|Fasting glucose was measured on day 0 and day 8|25 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype 11 is homozygous for the minor allele G, genotype 12 is heterozygous, genotype 22 is homozygous for the major allele A.|||mmHg||Standard Error|Mean
1444526|NCT00896389|Primary|Fasting Glucose Change After 7 Days of Low Dose (12.5 mg) of HCTZ|Values on Day 8 subtracts Day 0.|Fasting glucose was measured on day 0 and day 8|28 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
1444527|NCT00896389|Primary|Blood Pressure Change After 7 Days of High Dose (25 mg) of HCTZ|Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.|24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8|25 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
1444528|NCT00896389|Primary|Blood Pressure Change After 7 Days of Low Dose (12.5 mg) of HCTZ|Blood pressure change is defined as SBP or DBP average over the 24 hour period, Day 8 subtracts Day 0.|24-hr Ambulatory blood pressure were measured every hour on day 0 and day 8|28 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
1444529|NCT00896389|Secondary|Change in Plasma Sodium/Potassium Level During Low Dose of HCTZ|Na/K ratio is a function of kidney function|Plasma sodium and potassium measured from blood collected pre and post salt loading|28 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype 11 is homozygous for the minor allele G, genotype 12 is heterozygous, genotype 22 is homozygous for the major allele A.|||ratio||Standard Error|Mean
1444530|NCT00896389|Secondary|Change in Plasma Sodium/Potassium Level Due to Salt-loading|Na/K ratio is a function of kidney function|Plasma sodium and potassium measured from blood collected pre and post salt loading|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ratio||Standard Error|Mean
1444531|NCT00896389|Secondary|Change in Plasma Renin Activity Due to Salt-loading|Renin is an enzyme that mediates extracellular fluid and regulates blood pressure. Plasma renin activity (PRA) is a measure of the activity of the plasma enzyme renin. PRA is measured in the laboratory by incubating plasma at physiologic temperature in a buffer that facilitates its enzymatic activity. The natural substrate for the enzyme renin is angiotensinogen. Exogenous angiotensinogen is not added to the reaction mixture. This means that, in effect, the PRA results reported are dependent on both renin concentration and the concentration of its substrate in the patient's plasma. Renin cleaves angiotensinogen to produce a decapeptide, angiotensin I, the concentration of which is assayed using liquid chromatography accompanied by tandem mass spectroscopic detection (LC/MS/MS). PRA levels are reported as the amount of angiotensin I generated per unit of time. Change is defined as the post-salt loading values minus the pre-salt loading values|Renin was measured from blood collected pre and post salt loading|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ng/ml/h||Standard Error|Mean
1444532|NCT00896389|Secondary|Change in Plasma Aldosterone Level Due to Salt-loading|Aldosterone is a hormone that plays a critical role in homeostatic regulation of blood pressure. Change is defined as the post-salt loading values minus the pre-salt loading values|Aldosterone was measured from blood collected pre and post salt loading|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, genotype AA is homozygous for the major allele A.|||ng/dL||Standard Error|Mean
1444533|NCT00896389|Primary|Blood Pressure Change During Salt Loading|"Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured every 15 minutes for 4 hours.~Blood pressure change is calculated by the trapezoid method. Essentially we use the average of blood pressure at each pair of time points (for example, DBP 30min + DBP 15min)/2 + (DBP 45min + DBP 30min)/2 + … up to 4 hours.) normalized by baseline SBP/DBP."|Every 15 minutes for 4 hours|124 subjects were divided into 3 genotype groups based on their rs35929607 genotypes. Genotype GG is homozygous for the minor allele G, genotype AG is heterozygous, and genotype AA is homozygous for the major allele A.|||mmHg||Standard Error|Mean
1444534|NCT00896363|Secondary|Preliminary Pharmacokinetic/ Pharmacodynamic (PK/PD)Relationships for GSK163090 in Participants With MDD.|PK/PD relationships for GSK163090 in participants with MDD data was not collected.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|PK population.||||||
1444535|NCT00896363|Secondary|Average Concentration (Cave) at Steady State|PK samples were supposed to be collected to estimate individual specific parameters like Cave however data for this outcome was not collected.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|PK population.||||||
1444536|NCT00896363|Secondary|Area Under Concentration-time Curve (AUC) at Steady State|PK samples were supposed to be collected to estimate individual specific parameters like AUC however data for this outcome was not collected.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|PK population.||||||
1444537|NCT00896363|Secondary|Mean Last Observed Quantifiable Concentration (Ct) of GSK163090 Over the Period|Ctrough is defined as trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]). Concentration was reported at specified time points.|Day 4 (AM pre-dose), Day 7 (AM and PM pre-dose), Day 10 (AM and PM pre-dose), Day 14 (AM and PM pre-dose), Day 21 (AM pre dose), Day 28 (AM pre dose), Day 42 (AM pre-dose and 4-6 h post AM dose)|The ‘PK population' comprised of participants in the intent to treat population for whom a pharmacokinetic sample was obtained and analyzed.|||microgram per liter||Standard Deviation|Mean
1444538|NCT00896363|Primary|Number of Participants With All Adverse Events (AEs), and Serious Adverse Events (SAEs)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to Day 52|All subjects population. The number of participants available at the particular time point were used for analysis.|||Participants|||Number
1444539|NCT00896363|Primary|Mean of Change From Baseline in Heart Rate|Heart rate is the speed of the heartbeat measured by the number of contractions of the heart per minute, (beats per minute). Heart rate was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.|Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
1444540|NCT00896363|Primary|Mean of Change From Baseline in Systolic and Diastolic Blood Pressure (BP)|Semi-supine systolic and diastolic blood pressure was assessed at the specified time points. Measurements were taken after the participant has been semi-supine for at least 5 minutes. BP was measured at least every hour until the values were within the normal range. Day 1 was Baseline and change from Baseline was difference between the value at the time point analyzed and baseline value.|Baseline (Day 1) , Day 2, 3, 4, 5, 6, 7, 8, 14, 21, 28 and 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1444541|NCT00896363|Primary|Change From Baseline in Electrocardiogram (ECG) Values -PR Interval, QRS Duration, QT Interval, QTcB, QTcF, RR Interval|Data for change from Baseline was reported for PR Interval, QRS Duration, QT Interval, QTcB, QTcF, and RR Interval. 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTcB ,QTcF, and RR intervals. Day -1 evening (PM) was the Baseline for participants with only Day -1 records. Day 1 PM Dose was the Baseline for participants with Day 1 records. Baseline was the mean of replicate assessments. Change from Baseline was the difference between the value at the time point analyzed and baseline value.|Baseline (Day 1) and up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||milisecond (msec)||Standard Deviation|Mean
1444542|NCT00896363|Primary|Number of Participant of Urinanalysis Assessment Over Period|Urinalysis parameters included: Urine Occult Blood, Urine Ketones, Urine Ketones. data for number of participants with abnormal urinanalysis parameters was reported by dipstick method. dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. dipstick test gives results in a semi-quantitative manner, and results can be read as negative, Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Urine occult blood dipstick and urine general dipstick were semi quantitative results. Urine glucose and urine ketones dipstick results were in milimole per liter, urine protein dipstick results were in gram per liter.|Screening (Day -10 to -2), Day 14 and Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1444543|NCT00896363|Primary|Change From Baseline in Liver Chemistry- Direct Bilirubin and Total Bilirubin|Liver chemistry parameters: Direct Bilirubin and Total Bilirubin were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.|Baseline (screening) up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||UMOL/L||Standard Deviation|Mean
1444544|NCT00896363|Primary|Change From Baseline in Liver Chemistry -Alkaline Phosphatase (ALP), ALT, AST and GGT|Clinical liver chemistry parameters of Alkaline Phosphatase , ALT, AST, GGT were assessed on screening, Day 7, Day 14, Day 28 and Day 42. Screening was defined as Baseline. Change from Baseline in liver chemistry was the difference between the value at time point analyzed and screening.|Baseline (screening) up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||International unit per litre (IU/L)||Standard Deviation|Mean
1444545|NCT00896363|Primary|Number of Participants With Abnormal Chemistry Values of CCR|Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) were: albumin (unit: gram per liter): < 30, NA; alanine aminotransferase (ALT): NA, >= 3 times upper limit of normal; aspartate aminotransferase (AST): NA, >= 3 times upper limit of normal; total bilirubin: NA, >=1.5 times upper limit of normal; calcium: < 2.0, > 2.75; gamma glutamyl transferase (GGT): < 3.0, > 9; potassium: < 3.0, > 5.5; magnesium: < 0.5, > 1.23.|Up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1444546|NCT00896363|Primary|Number of Participants With Abnormal Hematology Values of Clinical Concern Range (CCR).|Only those parameters for which at least one value of CC was reported were summarized. Pre-defined limits of CC (CC Low [relative to the lower limit of normal], CC High [relative to the upper limit of normal]) were: hemoglobin (Hb): > 25, 180; hematocrit (Hct): > 0.075, 0.54; absolute neutrophil count (ANC): < 1.5, NA; platelet: < 100, > 550; white blood cells (WBC): < 3,> 20|Up to Day 42|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1444555|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
1444547|NCT00896363|Primary|Number of Participants With Suicidal Behavior and Suicidal Ideation Subscales of the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS was a clinician-rated scale that evaluated severity and change of suicidality by integrating both behaviour and ideation. The 2 of 3 sections of the scale were suicidal behavior and suicidal ideation. For suicidal behaviour participants were scored as non-suicidal-0, preparatory acts or behavior communicating ideation-01, aborted attempt-2, interrupted attempt-3 or actual attempt-4. The score ranges from 0-4, where 0 was absence of suicidal behavior and 4 being the most severe form of suicidal behavior. On the Suicidal Ideation scale, participants were scored as non-suicidal-0, wish to be dead-1, non-specific active suicidal thoughts-2, active suicidal ideation with associated thoughts of methods without intent-3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan-4, active suicidal ideation with plan and intent-5. The score ranges from 0-5, where 0 was absence of suicidal ideation and 5 being the most severe form of suicidal ideation.|Up to Day 52|All subjects population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1444548|NCT00896363|Primary|Change From Baseline in Quick Inventory of Depressive Symtomatology – Self Rated (QIDS-SR) Scale, on Day 14 and 42|The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle, and late insomnia or hypersomnia), appetite/weight increase/decrease and psychomotor agitation/retardation. A total score was obtained by summing scores on each domain. the scores ranges from 0 (none) to 27 (very severe), where the highest possible score was 27, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1. Change from Randomization in total score was the difference between QIDS total score at the time point being analyzed to randomization.|Baseline (Day 1, pre-dose), Day 14 and Day 42|Intent-to-treat population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1444549|NCT00896363|Primary|Change From Baseline in Bech Melancholia Subscale (BECH 6) Scale, on Day 14 and 42|The bech melancholia is sum of scores on 6 items- depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, somatic symptoms general (items 1, 2, 7, 8, 10 and 13 respectively). Each item having 5 responses. The items are rated on a scale of 0-4, where 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. Total possible score is 0-24. where the lowest possible score was 0, which represented an absence of depression and higher scores reflecting greater severity of diseases. Baseline was defined as the assessment done on Day 1. Change from baseline was the difference between BECH 6 scale at the time point being analyzed to randomization.|Baseline (Day 1, pre-dose), Day 14 and Day 42|Intent-to-treat population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1444550|NCT00896363|Primary|Change From Baseline in the Hamilton Depression Rating Scale (HAMD17), on Day 14 and 42|HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items were rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill). The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represents an absence of depression. Baseline was defined as the assessment done on Day 1 (pre-dose). Change from baseline in total Score was the difference between HAMD total score at the time point being analyzed to Day 1.|Baseline (Day 1, pre-dose), Day 14 and Day 42|Intent-to-treat population comprised of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
1444551|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
1444552|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
1444553|NCT00896337|Secondary|Walking Impairment Questionnaire Score-Stair Climbing|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.|||units on a scale||Standard Deviation|Mean
1444554|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
1444682|NCT00895947|Secondary|Negative Events Related to Cold/Flu Symptoms|Number of subjects in each group reporting one or days of occurrence of the following 6 negative events: (1) felt sick, (2) missed work, (3) went to the doctor, (4) went to the pharmacy, (5) took cold/flu medication, and (6) skipped a planned activity|16 weeks||||participants|||Number
1444556|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Speed|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.|||units on a scale||Standard Deviation|Mean
1444557|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
1444558|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.|||units on a scale||Standard Deviation|Mean
1444559|NCT00896337|Secondary|Walking Impairment Questionnaire Score - Distance|The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.|||units on a scale||Standard Deviation|Mean
1444560|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.|||percentage of lesions|Participants||Number
1444561|NCT00896337|Secondary|Restenosis Assessed by Duplex Ultrasound|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.|||percentage of lesions|Participants||Number
1444562|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable|||percentage of lesions|Participants||Number
1444563|NCT00896337|Secondary|Secondary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable|||percentage of lesions|Participants||Number
1444564|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.|||percentage of lesions|Participants||Number
1444565|NCT00896337|Secondary|Primary-assisted Patency (PAP)|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.|||percentage of lesions|Participants||Number
1444566|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable|||percentage of lesions|Participants||Number
1444928|NCT00893971|Primary|Spirometry Change From Baseline|Change from baseline for spirometery measures 12-hours post-dose|12 hours|Safety population|||Liters||Full Range|Mean
1444567|NCT00896337|Secondary|Primary Patency|Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable|||percentage of lesions|Participants||Number
1444568|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.|||ratio|Participants|Standard Deviation|Mean
1444569|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.|||ratio|Participants|Standard Deviation|Mean
1444570|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||ratio|Participants|Standard Deviation|Mean
1444571|NCT00896337|Secondary|Ankle-Brachial Index|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Hospital Discharge (1-2 days post-procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||ratio|Participants|Standard Deviation|Mean
1444572|NCT00896337|Secondary|Ankle-Brachial Index (ABI)|"Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:~Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.~Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation."|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||ratio|Participants|Standard Deviation|Mean
1444573|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.|||percentage of lesions|Participants||Number
1444574|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.|||percentage of lesions|Participants||Number
1444575|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.|||percentage of lesions|Participants||Number
1444576|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of lesions|Participants||Number
1444929|NCT00893971|Primary|ECG Change From Baseline|Change from baseline for ECG parameters 12-hours post-dose|12 hours|Safety population|||ms||Full Range|Mean
1448646|NCT00860470|Secondary|Very Pre-term|Risk of birth between 28 and 32 weeks of gestation|December 2014||||participants|||Number
1444577|NCT00896337|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of lesions|Participants||Number
1444578|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Very late stent thrombosis is defined as >365 days following the trial procedure."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable|||percentage of participants|||Number
1444579|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Very late stent thrombosis is defined as >365 days following the trial procedure."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable|||percentage of participants|||Number
1444580|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable|||percentage of participants|||Number
1444581|NCT00896337|Secondary|Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Late stent thrombosis is defined as >30 days to 365 days following the trial procedure."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable|||percentage of participants|||Number
1444582|NCT00896337|Secondary|Sub-acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure."|>24 Hours to <=30 Days Post-index procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable|||percentage of participants|||Number
1444583|NCT00896337|Secondary|Acute Stent Thrombosis|"Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion~Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure."|24 Hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of participants|||Number
1444584|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.|||percentage of participants|||Number
1444585|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.|||percentage of participants|||Number
1444586|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of participants|||Number
1444587|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Post-procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of participants|||Number
1444588|NCT00896337|Secondary|Rutherford Classification Distribution|"Rutherford Classification is used to assess lower extremity ischemia as shown below:~0 = Asymptomatic~= Mild claudication~= Moderate claudication~= Severe claudication~= Ischemic rest pain~= Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Pre-procedure/baseline|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of participants|||Number
1444589|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.|||percentage of limbs|Participants||Number
1444590|NCT00896337|Secondary|Late Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.|||percentage of limbs|Participants||Number
1444591|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of limbs|Participants||Number
1444592|NCT00896337|Secondary|Early Hemodynamic Success|Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.|||percentage of limbs|Participants||Number
1444593|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.|||percentage of patients|||Number
1444594|NCT00896337|Secondary|Late Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.|||percentage of patients|||Number
1444595|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable|||percentage of participants|||Number
1444596|NCT00896337|Secondary|Early Clinical Success|"Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:~Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss – non-healing ulcer, focal gangrene with diffuse pedal edema"|Hospital Discharge|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable|||percentage of participants|||Number
1444597|NCT00896337|Secondary|Procedure Success|Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).|In hospital (1-2 days post procedure)|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of participants|||Number
1444598|NCT00896337|Secondary|Technical Success|Residual lesion stenosis <=30% based on visual assessment immediately postprocedure|Index procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of lesions|Participants||Number
1444599|NCT00896337|Secondary|Myocardial Infarction (MI)|Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.|Index hospitalization|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of participants|||Number
1444600|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.|||percentage of participants|||Number
1444625|NCT00896168|Secondary|Change From Baseline in Participant’s Pain Visual Analogue Scale (VAS) Score at Week 26|Participant’s pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Units on a scale||Standard Deviation|Mean
1444930|NCT00893971|Primary|ECG Change From Baseline|Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)|12 hours|Safety population|||bpm||Full Range|Mean
1444601|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.|||percentage of participants|||Number
1444602|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.|||percentage of participants|||Number
1444603|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
1444604|NCT00896337|Secondary|Target Vessel Revascularization (TVR)|"Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.~A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia."|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of participants|||Number
1444605|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.|||percentage of participants|||Number
1444606|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.|||percentage of participants|||Number
1444607|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.|||percentage of participants|||Number
1444608|NCT00896337|Secondary|Amputation of Index Limb|Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
1444609|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|3 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.|||percentage of participants|||Number
1444610|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.|||percentage of participants|||Number
1444611|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|1 Year|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.|||percentage of participants|||Number
1444612|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
1448647|NCT00860470|Secondary|Extremely Pre-term|Risk of birth before 28 weeks gestation|December 2014||||participants|||Number
1444613|NCT00896337|Secondary|Death|Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions|30 Days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.|||percentage of participants|||Number
1444614|NCT00896337|Primary|Device- and/or Procedure-related Major Adverse Events (MAE)|MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months|9 Months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.|||percentage of participants|||Number
1444615|NCT00896233|Primary|Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.|||percent treatment difference||95% Confidence Interval|Number
1444616|NCT00896233|Primary|Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared."|14 days|Participants analyzed were Completers.|||percent treatment difference||95% Confidence Interval|Number
1444617|NCT00896233|Primary|Repeated Mean Liver Elastic Stiffness (kPa) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.|||kPa||Standard Deviation|Mean
1444618|NCT00896233|Primary|Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements|"Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI's selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI's) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation."|14 days|Participants analyzed were Completers.|||kPa||Standard Deviation|Mean
1444619|NCT00896168|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26|ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Millimeter/1 hour||Standard Deviation|Mean
1444620|NCT00896168|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 26|CRP is a protein found in the blood, the levels of which rise in response to inflammation.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data. Here, 'N' signifies participants who were evaluated for this outcome measure.|||Milligram/Liter||Standard Deviation|Mean
1444621|NCT00896168|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26|The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Units on a scale||Standard Deviation|Mean
1444622|NCT00896168|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 26|Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Minutes||Standard Deviation|Mean
1444623|NCT00896168|Secondary|Change From Baseline in Physicians' Global Disease Assessment at Week 26|Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using “0=no active RA” to “100=most serious active RA” scale.|Baseline and Week 26|FAS population included participants who received at least 1 dose of study medication and possessed the record of efficacy data.|||Units on a scale||Standard Deviation|Mean
1444624|NCT00896168|Secondary|Change From Baseline in Participants' Global Disease Assessment at Week 26|"Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using “0 mm=very good” to “100 mm=very poor scale."|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Units on a scale||Standard Deviation|Mean
1448648|NCT00860470|Secondary|Preterm Birth|Risk of being born before 37 weeks of gestation|December 2014||||participants|||Number
1444626|NCT00896168|Secondary|Change From Baseline in Tender Joints Count at Week 26|Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Tender joints||Standard Deviation|Mean
1444627|NCT00896168|Secondary|Change From Baseline in Swollen Joints Count at Week 26|Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).|Baseline and Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Swollen joints||Standard Deviation|Mean
1444628|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response|ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Percentage of participants|||Number
1444629|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response|ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|The FAS population included participants who received at least 1 dose of study medication and had post efficacy data.|||Percentage of participants|||Number
1444630|NCT00896168|Primary|Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response|ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants’ assessment of pain; participants’ global assessment of disease activity; physician’s global assessment of disease activity; participants’ assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).|Week 26|Full analysis set (FAS) included participants who received at least 1 dose of study medication and had post efficacy data.|||Percentage of participants|||Number
1444631|NCT00896064|Secondary|Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities|"Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.~Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening"|At 1 and 6 days post-booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444632|NCT00896064|Secondary|Number of Subjects With Any SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 30)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444633|NCT00896064|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444634|NCT00896064|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444635|NCT00896064|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444636|NCT00896064|Secondary|Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein|Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.|Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.|||Titers||95% Confidence Interval|Geometric Mean
1448649|NCT00860470|Secondary|Still Birth Rates|Risk of Still birth|December 2014||||participants|||Number
1444637|NCT00896064|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins|Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD.|Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom post results were available for at least one assay.|||LU/mL||95% Confidence Interval|Geometric Mean
1444638|NCT00896064|Primary|Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities|"Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.~Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening"|At Days 1 and 6 post-booster vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444639|NCT00896064|Primary|Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Day 30)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444640|NCT00896064|Primary|Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444641|NCT00896064|Primary|Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444642|NCT00896064|Primary|Number of Subjects With Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
1444643|NCT00896051|Secondary|Time to Virologic Failure|The table below shows the number of days to virologic failure defined as a plasma viral load (VL) > 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL <50, and <400 copies/mL according to the time to loss of virologic response [TLOVR] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Days||95% Confidence Interval|Median
1444644|NCT00896051|Secondary|Time to Confirmed Virologic Response|The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) <50 copies/mL, and plasma VL <400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method.|Prebaseline to Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Days||95% Confidence Interval|Median
1444645|NCT00896051|Secondary|Change From Pre-Baseline in Log10 Viral Load Over Time|The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method.|Pre-Baseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||log10 (Copies/mL)||Standard Error|Mean
1444646|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method|The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (<50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48.|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Participants|||Number
1444683|NCT00895947|Secondary|Impact of Cold/Flu Symptoms|Number of subjects in each group reporting that cold/flu symptoms impacted the following 9 measures of daily life: ability to (1) think clearly, (2) sleep well, (3) breathe easily, (4) walk, climb stairs and exercise, (5) perform daily tasks, (6) work outside the home, (7) work inside the home, (8) interact with others, and (9) live personal life.|16 weeks||||participants|||Number
1444647|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method|The table below shows the percentage of participants with a virologic response defined as a viral load <50 Copies/mL and <400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method.|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Particpants|||Number
1444648|NCT00896051|Secondary|The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method|The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) <50 copies/mL, and with plasma VL <400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change).|Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Participants|||Number
1444649|NCT00896051|Secondary|Change From Prebaseline in CD4+ Cell Count Over Time|The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method.|Prebaseline, Baseline, Weeks 4, 12, 24, 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||CD4+ cell count||Standard Error|Mean
1444650|NCT00896051|Primary|Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48|The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change).|Week 48|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||Percentage of Participants||95% Confidence Interval|Number
1444651|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/mL||Standard Deviation|Mean
1444652|NCT00896051|Primary|Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax).|Week 2|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng/ml||Standard Deviation|Mean
1444653|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/ml||Standard Deviation|Mean
1444654|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng/ml||Standard Deviation|Mean
1444655|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/ml||Standard Deviation|Mean
1444656|NCT00896051|Primary|Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng/ml||Standard Deviation|Mean
1444684|NCT00895947|Secondary|Symptom Incidence/Severity|Number of subjects in each group reporting 13 different cold/flu symptoms assessed weekly|16 weeks||||participants|||Number
1448650|NCT00860470|Secondary|Post-neonatal Mortality|Risk of Post-neonatal Mortality (29th -180th day of life)|Dec 2014||||participants|||Number
1444657|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the parameter reported.|||ng.h/mL||Standard Deviation|Mean
1444658|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Reference); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population).|||ng/ml||Standard Deviation|Mean
1444659|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.|||ng.h/mL||Standard Deviation|Mean
1444660|NCT00896051|Primary|Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)|The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax).|Day -1 (Pretreatment); Week 2 (Test)|The population analyzed included all randomized participants with at least 1 etravirine (ETR) intake regardless of their compliance with the protocol (ie, the efficacy ITT population) for which data was available for the PK parameter reported.|||ng/ml||Standard Deviation|Mean
1444661|NCT00896038|Primary|PTSD Total Symptom Severity Score|PTSD total symptom severity was measured using the Clinician-Administered PTSD Scale (CAPS). This is a 30-item interview-based questionnaire that measures symptom severity during the past week. The total symptom severity score ranges from 0 (lowest symptom severity) to 136 (highest symptom severity).|Day 29 of the treatment period, 2 days after the final script presentation|The analysis included subjects who completed the CAPS at both baseline (Day 1) and Day 29, and who had data for the baseline covariates used in the analysis|||units on a scale||Standard Error|Mean
1444662|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444663|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444664|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444665|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444666|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444679|NCT00896025|Primary|The Primary Outcome is to Compare All Patients Who Survive (With or Without Transplant) to Those Who Die.||3 Weeks, 1-year and 2-year follow-ups|The estimated minimum enrollment for any statistical validity was 100 patients. Due to low enrollment (8 participants) and the likelihood of generating any meaningful study data moving forward, the DSMB recommended the early termination of the study. Zero participants were analyzed because the small sample size would not yield meaningful results||||||
1444667|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444668|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444669|NCT00896038|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444670|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444671|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444672|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444673|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444674|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444675|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444676|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444677|NCT00896038|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||units on a scale||Standard Error|Mean
1444678|NCT00896025|Secondary|To Compare Patients Who Survive Without Transplantation to All Other Patients Enrolled in This Study (Those Who Receive a Transplant and Live, Those Who Receive a Transplant and Die, or Those Who Die Before Transplantation).||3 Weeks, 1-year and 2-year follow-ups|||||||
1448651|NCT00860470|Secondary|Neonatal Mortality|Risk of neonatal Mortality (28 days of life)|Dec 2014||||participants|||Number
1444685|NCT00895947|Primary|Frequency of Influenza-like Illness|Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).|16 weeks|Intent-to-treat, defined as all randomized subjects who took at least one dose of study drug|||participants|||Number
1444686|NCT00895934|Secondary|Relapse-free Survival (RFS)|Estimated using Kaplan-Meier method. Logistic regression will be used as a tool to assess the association of various factors with the probability of response, recognizing that the power to detect statistically significant associations will be limited due to the sample size (and expected number of responses). The impact of remission and post-remission therapy on RFS will be assessed using Cox regression with remission and therapy treated as time-dependent covariates.|Up to 3 years|||||||
1444687|NCT00895934|Primary|Efficacy Defined as Best Response Achieved During Study Treatment Measured by Complete Remission (CR) Rate||Up to 3 years||||participants|||Number
1444688|NCT00895934|Primary|Dose-limiting Toxicity and Maximum Tolerated Dose of Vorinostat (Phase I)||42 days|||||||
1444689|NCT00895895|Secondary|Percentage of Participants Who Were Responders at Week 24|Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.|Week 24|ITT; N=number of participants with evaluable data|||percentage of participants|||Number
1444690|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
1444691|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Simple Movement Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
1444692|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
1444693|NCT00895895|Secondary|Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
1444694|NCT00895895|Secondary|Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24|CANTAB-RTI assessed participant’s reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||correct trials||Standard Deviation|Mean
1444695|NCT00895895|Secondary|Change From Baseline in CANTAB PRM-Percentage Correct at Week 24|CANTAB-PRM assessed participant’s visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||percentage of correct answers||Standard Deviation|Mean
1444696|NCT00895895|Secondary|Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24|CANTAB-PRM assessed participant’s visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||msec||Standard Deviation|Mean
1444754|NCT00895583|Secondary|Percentage of Participants With Stomatitis|Includes adverse events based on categorization by the investigator as stomatitis, regardless of the event preferred term in Medical Dictionary for Regulatory Activities (MedDRA)|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
1444697|NCT00895895|Secondary|Change From Baseline in CANTAB SWM Strategy at Week 24|CANTAB-SWM assessed participant’s ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||boxes||Standard Deviation|Mean
1444698|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
1444699|NCT00895895|Secondary|Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
1444700|NCT00895895|Secondary|Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
1444701|NCT00895895|Secondary|Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24|CANTAB-SWM assessed participant’s retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
1444702|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||correct choices||Standard Deviation|Mean
1444703|NCT00895895|Secondary|Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||patterns||Standard Deviation|Mean
1444704|NCT00895895|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24|CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||errors||Standard Deviation|Mean
1444705|NCT00895895|Secondary|Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24|Caregiver and participant interview-based tool to rate the overall impression of participant’s clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.|Baseline, Week 24|ITT; N=number of evaluable participants|||participants|||Number
1444722|NCT00895752|Secondary|Aberrant Behavior Checklist|The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. The ABC has 5 subscales: Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), and Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe). Items are rated from 0 (not at all) to 3 (severe).|Week 6||||units on a scale||Standard Deviation|Mean
1444706|NCT00895895|Secondary|Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24|Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances|Baseline, Week 24|ITT; N=number of participants with evaluable data|||unit on a scale||Standard Deviation|Mean
1444707|NCT00895895|Secondary|Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24|Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant’s actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of “Not Applicable” was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.|Baseline, Week 24|ITT; N=number of participants with evaluable data|||percentage of yes answers||Standard Deviation|Mean
1444708|NCT00895895|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24|14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.|Baseline, Week 24|Intent to treat (ITT) population: randomized participants who took at least one dose of study medication, had a baseline evaluation and had at least one on-treatment post-baseline evaluation for the ADAS-Cog; Number of Participants Analyzed (N): number of evaluable participants|||units on a scale||Standard Deviation|Mean
1444709|NCT00895843|Secondary|Pain Control/Relief|Patient satisfaction scores|48 hours after surgery (end of study)|||||||
1444710|NCT00895843|Secondary|Time to Rescue|Time taken for rescue medication requirement|Between 30mins and 48 hours|||||||
1444711|NCT00895843|Secondary|Mean Pain Intensity|Mean VAS scores of pain intensity for each time points|30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery|||||||
1444712|NCT00895843|Primary|Number of Patients Needing Rescue Medication|Number of patients who required rescue medication within 6 hours|At 6 hours||||Participants|||Number
1444713|NCT00895830|Primary|Experienced Post-operative Nausea or Vomiting||24 hours|ITT|||participants|||Number
1444714|NCT00895817|Secondary|Endoscopic Change|Following therapy, resolution of EE findings will be assessed.|8 weeks|||||||
1444715|NCT00895817|Secondary|Symptom Score|Using a validated questionnaire, symptoms will be assessed at baseline and following therapy.|8 weeks|||||||
1444716|NCT00895817|Primary|Number of Participants Who Responded|Histologic resolution of esophageal eosinophilia. Response is defined as achieving < 7 eosinophils/high power field in both the proximal and distal esophagus.|8 weeks|Sample size estimation was based on the assumptions:10% of the EE patients will respond to PPI compared to 55% of patients treated with steroids. Controlling the probability of a Type I error at alpha=0.05, a sample of 38 patients in the treatment groups (19 in each arm) will have 80% power to detect a difference in treatment response of 45%.|||participants|||Number
1444717|NCT00895752|Secondary|Extra-cellular Signal-relatedness Kinase (ERK)|ERK activations times, as defined as the time in minutes for ERK phosphorylation to reach the half maximal level.|Screen and Week 6||||minutes||Standard Deviation|Mean
1444718|NCT00895752|Secondary|The Social Reciprocity Scale|The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment.|Week 6||||units on a scale||Standard Deviation|Mean
1444719|NCT00895752|Secondary|The Peabody Picture Vocabulary Test|The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability in standard American English vocabulary. This test has been nationally standardized using examinees from various age groups, from children to adults. Thus, the raw scores are equated to mental age, using the norms obtained from standardization. The total standard scores range from 40 (worse receptive vocabulary) to 160 (better receptive vocabulary). The scores can also be converted to percentile rank.|Week 6||||units on a scale||Standard Deviation|Mean
1444720|NCT00895752|Secondary|The Clinical Global Impression - Severity Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill|Week 6||||units on a scale||Standard Deviation|Mean
1444721|NCT00895752|Secondary|The ADHD Rating Scale|The ADHD Rating Scale is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder. The ADHD Rating Scale-IV is completed by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. The total score can range from 0 to 54, with a higher score indicating greater severity|Week 6||||units on a scale||Standard Deviation|Mean
1444723|NCT00895752|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CY-BOCS PDD has been utilized in a largescale clinical treatment study of repetitive behavior in idiopathic ASDs. CYBOCS-PDD scores range from 0 to 20 and measure repetitive/compulsive behavior and not obsessions. Higher score indicate worse outcome.|Obtained at Baseline and Week 6||||Units on a Scale||Standard Deviation|Mean
1444724|NCT00895752|Primary|Clinical Global Impression-Improvement (CGI-I)|The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse|Obtained at Week 6||||units on a scale||Full Range|Mean
1444725|NCT00895661|Secondary|Incidence of Severity of Infusion Reactions, Infections and Neutropenia|Toxicity grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening|24 months||||Participants|||Count of Participants
1444726|NCT00895661|Secondary|Progression-free Survival (PFS)|"Progressive Disease (PD) or Relapsed Disease (RD):~Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis.~>50% increase from nadir in the SPD of any previous lesions PFS is number of participants who have not died or had PD or RD."|5 years||||Participants|||Count of Participants
1444727|NCT00895661|Secondary|Overall Response Rate (ORR)|"Complete Response (CR): see definition in primary outcome~Partial Response (PR):~≥50% decrease in SPD of up to 6 largest dominant masses~No new sites of disease or increase in the size of the other nodes, liver, or spleen.~Splenic and hepatic nodules must regress by at least 50% in the SPD.~Overall Response (OR) = CR + PR."|after a median number of 8 maintenance cycles, up to 24 weeks||||Participants|||Count of Participants
1444728|NCT00895661|Primary|Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas|"CR requires all of the following:~Regression to normal size on CT (≤ 1.5 cm in their greatest transverse diameter for nodes ≥ 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to <1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).~The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.~If bone marrow is known to be involved at the beginning, then repeat biopsy documents clearance"|after a median number of 8 maintenance cycles, up to 24 weeks||||Participants|||Count of Participants
1444729|NCT00895622|Secondary|Histopathologic Correlates of PFS Including Light Microscopy, Immunohistochemical Analysis, and Microarray Analysis|Biomarker data has not yet been obtained and therefore this outcome measure cannot be reported.|From registration to 3 years|||||||
1444730|NCT00895622|Secondary|Molecular Correlative Studies|Biomarker data has not yet been obtained and therefore this outcome measure cannot be reported.|From registration to 3 years|||||||
1444731|NCT00895622|Secondary|Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping|A pathology review was conducted both by the institution and centrally, with three possible choices for grade / subtype: World Health Organization (WHO) Grade I / benign; WHO grade II / atypical; WHO grade III / anaplastic. Data is presented for all risk groups combined.|Baseline|Eligible patients with central and site reviews|||Participants|||Count of Participants
1444732|NCT00895622|Secondary|Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters||After treatment delivery||2018-12-31|12/2018||||
1444733|NCT00895622|Secondary|MRI Imaging Predictors as Assessed by Central Neuroradiology Review at Diagnosis, at Any Failure, and at 3 Years||From registration to 3 years||2018-12-31|12/2018||||
1444734|NCT00895622|Secondary|Progression-free Survival Rate at 3 Years (Kaplan-Meier Method)|Progression was determined by central review of MRI exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.|From registration to 3 years|Eligible patients who started study treatment and evaluable for 3-year progression-free survival|||percentage of participants||95% Confidence Interval|Number
1444735|NCT00895622|Secondary|Overall Survival Rate at 3 Years|Overall survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From registration to 3 years|Eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1444736|NCT00895622|Secondary|Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]|Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown. Late adverse events are those occurring more than 90 days from start of radiation therapy.|Ninety-one days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 6.3 years.|Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.|||Participants|||Count of Participants
1444737|NCT00895622|Secondary|Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]|Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From start of radiation to 90 days.|Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.|||Participants|||Count of Participants
1448652|NCT00860470|Primary|Infant Mortality Through 6 mo of Age|Risk of Infant Mortality to Age 6 months (180 days)|Dec 2014||||participants|||Number
1444738|NCT00895622|Primary|Progression-free Survival Rate at 3 Years|Progression was determined by central review of MRI exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival (PFS) rates are estimated using the binomial method.|From registration to 3 years|Eligible patients who started study treatment and evaluable for 3-year progression-free survival|||percentage of participants||95% Confidence Interval|Number
1444739|NCT00895583|Secondary|Percentage of Participants With Malignancy|Includes any adverse events based on categorization by the investigator as 'malignancy', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
1444740|NCT00895583|Secondary|Percentage of Participants With Polyomavirus Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'polyomavirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
1444741|NCT00895583|Secondary|Percentage of Participants With Cytomegalovirus (CMV) Infection|Includes adverse event terms reported by the investigator to be attributed to the organism 'cytomegalovirus', regardless of the preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
1444742|NCT00895583|Secondary|Percentage of Participants With Infection|Includes adverse events based on categorization by the investigator as 'infection', regardless of the event preferred term in MedDRA.|From randomization up to 24 months after transplantation (On-Therapy)|Safety Population|||percentage of participants|||Number
1444743|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes Receiving Treatment for Diabetes (Insulin and Non-Insulin)|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged between baseline and Month 12 or Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose ≥126 mg/dL after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization.|12 Months and 24 Months|Safety Population. Only participants with new-onset diabetes mellitus at the beginning of the analysis interval were included; those with pre-existing diabetes were excluded from the analysis.|||percentage of participants|||Number
1444744|NCT00895583|Secondary|Percentage of Participants With New-Onset Diabetes|Participants were considered as having new onset diabetes during the On-therapy period if any of the below events emerged from baseline to Month 24: 1) at least 30 days continuous, or at least 25 days non-stop (without gap) use of any diabetic treatment after randomization; 2) a fasting glucose greater than or equal to (≥)126 milligrams per deciliter (mg/dL) after randomization; or 3) a non-fasting glucose ≥200 mg/dL after randomization, were included in the new-onset diabetes population. Events at Months 12 or 24 occurred from baseline to On-therapy Month 12 and from On-therapy Months 12 to 24, respectively.|From Baseline to On-Therapy Month 12, from Baseline to On-Therapy Month 24, and from On-Therapy Month 12 up to On-Therapy Month 24|Safety Population; participants at risk of new-onset diabetes mellitus at the beginning of the analysis interval were included and those with pre-existing diabetes were excluded from the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1444745|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Body Mass Index (BMI; in Kilograms Per Square Meter [kg/m^2])|BMI = Weight (kg)/(Height*Height) (square meters [m^2]).|Baseline, Month 12|Safety Population|||kg/m^2||Standard Error|Mean
1444746|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in HOMA-Beta Cell (HOMA-B; Fasting)|"The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.~HOMA-B = 20 * insulin (µU/L) / fasting plasma glucose (mmol/L) minus (-) 3.5 Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population|||percentage beta cell function||Standard Error|Mean
1444747|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Homeostasis Model Assessment Insulin Resistance (HOMA-IR; Fasting)|"The HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements:~HOMA-IR = fasting plasma glucose (mmol/L) multiplied by (*) fasting plasma insulin in microunits per liter (µU/L) divided by (/) 22.5.~Participants taking insulin within 12 hours were excluded from the analysis."|Baseline, Month 12|Safety Population|||insulin resistance score||Standard Error|Mean
1444748|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Waist Circumference(Centimeters [cm])||Baseline, Month 12|Safety Population|||cm||Standard Error|Mean
1444749|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Weight (Kilograms [kg])||Baseline, Month 12|Safety Population|||kg||Standard Error|Mean
1444750|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Insulin (Picomoles Per Liter [Pmol/L])||Baseline, Month 12|Safety Population|||pmol/L||Standard Error|Mean
1444751|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Fasting Glucose (mmol/L)||Baseline, Month 12|Safety Population|||mmol||Standard Error|Mean
1444752|NCT00895583|Secondary|Change From Pre-Randomization to 12 Months Post-Transplantation in Hemoglobin A1C (Liter Per Liter [L/L])|Ratio of hemoglobin A1c to normal hemoglobin.|Baseline, Month 12|Safety Population|||L/L||Standard Error|Mean
1444753|NCT00895583|Secondary|Percentage of Participants Requiring Treatment for Stomatitis by Treatment Type|Included treatments (analgesics, dental paste, topical antifungal, topical steroids, or other) prior to randomization, during the on-therapy period (up to 19 to 21 months post-randomization) and the off-therapy period (up to 24 months post-transplantation).|On-Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population|||percentage of participants|||Number
1444931|NCT00893971|Primary|Vital Sign Change From Baseline, SpO2|Vital Sign Change from baseline 12-hours post-dose SpO2 (%)|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter|||% blood oxygen saturation level||Full Range|Mean
1444755|NCT00895583|Secondary|Percentage of Participants With Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor Block (ARB) Use|Included ACEI or ARB use prior to randomization, during the on-therapy period (up to 19 to 21 months post randomization) and the off-therapy period (up to 24 months post-transplantation).|Pre-randomization, On-Therapy Period (up to 21 months post-randomization), and Off-Therapy Period (up to 24 months post-transplantation)|ITT Population|||percentage of participants|||Number
1444756|NCT00895583|Secondary|Spot and 24 Hour Urine Protein to Creatinine Ratio (UPr/Cr)|Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline and Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||UPr/Cr||Standard Deviation|Mean
1444757|NCT00895583|Secondary|Percentage of Participants Requiring Anti-Hypertensive Medication, Diabetes Agents, Lipid-Lowering Agents, or Erythropoiesis Stimuating Agents (ESAs)||Baseline, Months 12 and 24|ITT Population|||percentage of participants|||Number
1444758|NCT00895583|Secondary|Change From Baseline (Pre-Randomization) to 12 and 24 Months Post-Transplantation in Fasting Lipid Parameters (Millimoles Per Liter [mmol/L])|Parameters assessed included total cholesterol (TC), triglycerides, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C); collected when participant was in a fasting state.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||mmol/L||Standard Error|Mean
1444759|NCT00895583|Secondary|Percentage of Participants With Anemia, Thrombocytopenia, or Leukopenia|Anemia was defined as hemoglobin less than or equal to (≤)10 grams per deciliter (g/dL); leukopenia was defined as white blood cell (WBC) count ≤2000 per cubic millimeters (/mm^3); and thrombocytopenia was defined as platelets ≤100,000/mm^3. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 12 and 24|Safety Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1444760|NCT00895583|Secondary|Percentage of Participants With Antibody Use in Treatment of Acute Rejection|Number of participants who experienced an adverse event (AE) of rejection was used as the denominator in the determination of percentage of participants with antibody use in treatment of acute rejection.|On Therapy Period (up to 21 months post-randomization) and Off-Therapy Period (up to 24 months post-transplantation)|Safety Population; only participants with an AE of rejection were included in the analysis.|||percentage of participants|||Number
1444761|NCT00895583|Secondary|Number of Participants With BCAR by Severity of First BCAR and Time of Onset From Post-Randomization to 6, 12, 18, and 24 Months Post-Transplant|BCAR was categorized as antibody-mediated (AM) or T-cell. AM BCAR severity was graded as Grade I (mild), Grade II (moderate), and Grade III (severe). T-cell BCAR severity was graded as 'Grade Ia, Ib (mild), Grade IIa, IIb (moderate), and Grade III (severe). If a participant had both T-cell BCAR and antibody-mediated BCAR on the first rejection, the participant was counted in each category.|Months 6, 12, 18, and 24|ITT Population|||participants|||Number
1444762|NCT00895583|Secondary|Percentage of Participants With First On-Therapy BCAR From Transplantation Occurring at 12 and 24 Months|Defined as the first BCAR occurring during the On-Therapy period based on the ITT population. Time to first BCAR was the days from transplantation to the date of BCAR.|Months 12 and 24|ITT Population|||percentage of participants|||Number
1444763|NCT00895583|Secondary|Percentage of Participants With BCAR Post-Randomization to 6, 12, 18, and 24 Months Post-Transplantation|BCAR was defined according to updated Banff criteria (2007) for renal allograft rejection.|Post-Randomization to 6, 12, 18, and 24 months Post-Transplantation|ITT Population|||percentage of participants|||Number
1444764|NCT00895583|Secondary|Percentage of Participants With Graft Loss (Including Death) at 12 and 24 Months Post-Randomization|Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for ≥56 days with no return of graft function), or death.|Post-randomization to Months 12 and 24 Post-Transplantation|ITT Population|||percentage of participants|||Number
1444765|NCT00895583|Secondary|Percentage of Participants With Biopsy-Confirmed Acute Rejection (BCAR), Graft Loss, or Death From Randomization to 24 Months Post-Transplantation|Biopsy-confirmed acute rejection was defined according to updated Banff criteria (2007) for renal allograft rejection. Graft loss was defined as physical loss (nephrectomy or retransplantation), functional loss (requiring dialysis for greater than or equal to [≥]56 days with no return of graft function), or death.|Post-randomization to Month 24 post-transplantation|ITT Population|||percentage of participants|||Number
1444766|NCT00895583|Secondary|Change From Randomization in Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in mcmol/L. Baseline was defined as the last assessment prior to first administration of study drug.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.|||mcmol/L||Standard Error|Mean
1444767|NCT00895583|Secondary|Serum Creatinine (On-Therapy Analysis)|Serum creatinine was measured in micromillimoles per liter (mcmol/L). Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. n=number of participants assessed for the specified parameter at a given visit.|||mcmol/L||Standard Deviation|Mean
1444768|NCT00895583|Secondary|Slope of Calculated GFR (MDRD) From Randomization to 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Timepoints were calculated as study days, relative to the time of randomization of study medication. All available on-therapy values were included. Observed data were multiplied by a scale factor of 365, expressing the slope as an annual change.|Baseline, Month 24|On-Therapy analysis of the slope comprised the data collected from the on-therapy evaluations for all the participants in the ITT population; data collected from participants receiving sirolimus during the first 3 weeks post-randomization for safety monitoring were excluded from the analysis.|||mL/min/1.73 m^2 per year||95% Confidence Interval|Mean
1444932|NCT00893971|Primary|Vital Sign Change Baseline; Blood Pressure|Vital sign change baseline; blood pressure|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter|||mmHg||Full Range|Mean
1444769|NCT00895583|Secondary|Change From Randomization in Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Error|Mean
1444770|NCT00895583|Secondary|Calculated GFR Using MDRD (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS. Baseline was defined as the last nonmissing assessment before or on the date of the first dose of test article.|Baseline, Months 6, 12, 18, and 24|On-Therapy Population: all participants who remained on assigned study therapy up to the point of discontinuation. number (n)=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Deviation|Mean
1444771|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥10 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.|||percentage of participants|||Number
1444772|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥7.5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population. Missing GFR was imputed as follows: 1) GFR=0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.|||percentage of participants|||Number
1444773|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 and 24 Months Post-Transplantation (Intent-to-Treat [ITT] Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Months 12 and 24|ITT Population: all randomized participants who received at least 1 dose of the assigned therapy after randomization. Missing GFR was imputed as follows: 1) GFR equals (=)0 after graft loss and 2) last observed value prior to missing was carried forward for death (with functioning graft), early termination or skipped assessment.|||percentage of participants|||Number
1444774|NCT00895583|Secondary|Percentage of Participants With Improvement of ≥5 mL/Min/m^2 in Calculated GFR at 12 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the MDRD equation using either serum creatinine traceable to IDMS or serum creatinine not traceable to IDMS.|Baseline, Month 12|On-Therapy Population (12 Months): all randomized participants who remained on assigned study therapy through 12 months post-transplantation.|||percentage of participants|||Number
1444775|NCT00895583|Primary|Percentage of Participants With Improvement of Greater Than or Equal to [≥]5 Milliliters Per Minute Per 1.73 Square Meters (mL/Min/m^2) in Calculated Glomerular Filtration Rate (GFR) at 24 Months Post-Transplantation (On-Therapy Analysis)|GFR was calculated using the Modified Diet in Renal Disease (MDRD) equation using either serum creatinine traceable to isotope dilution mass spectrometry (IDMS) or serum creatinine not traceable to IDMS.|Baseline, Month 24|On-Therapy Population (24 Months): all randomized participants who remained on assigned study therapy through 24 months post-transplantation.|||percentage of participants|||Number
1444776|NCT00895531|Primary|Postoperative Pain|Pain as reported on a verbal rating scale ( VRS) (0–10, 0 = no pain, 10 = worse pain imaginable).|48 hours||||units on a scale||Standard Deviation|Mean
1444777|NCT00895453|Primary|Candida Culture Free After Maintenance Therapy|candida culture free (monthly vaginal cultures were obtained)|12 months||||participants|||Number
1444778|NCT00895310|Secondary|Duration of Stable Disease||From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Days||Full Range|Median
1444779|NCT00895310|Secondary|Progression Free Survival|Response Evaluation Criteria In Solid Tumors (RECIST) radiographic criteria for progression|From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Days||95% Confidence Interval|Median
1444780|NCT00895310|Secondary|PSA Response (>30% From Baseline)||From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Participants|||Count of Participants
1444781|NCT00895310|Primary|Prostate Specific Antigen (PSA) Response (>50% Reduction From Baseline)|Percentage of patients who achieved a clinically significant decline in Prostate Specific Antigen (PSA) after initiation of ketoconazole therapy, defined as a >=50% decrease in PSA.|From date of enrollment, every Cycle (4 weeks), until disease progression, unacceptable toxicities, study withdrawal, or death from any cause, whichever came first, assessed up to 2 years||||Participants|||Count of Participants
1444782|NCT00895284|Primary|Total Procedure Time - Skin Incision to Skin Closure||At skin closure.|The study was terminated due to lack of funding; due to the small sample size, no analysis was done.||||||
1444783|NCT00895245|Secondary|Impact of Cisplatin-induced Nausea and Vomiting on Daily Life During the 5 Day Period Following Cisplatin Infusion for Multiple Cycles as Measured by the Functional Living Index-Emesis Questionnaire|"FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index – Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient’s life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being none /not at all and 1 being a great deal. The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of >108 defines those patients who had a minimal impact of CINV on quality of life. All particpants discontinued the trial after one cycle of cisplatin."|5 days following cisplatin infusion|Two patients did not complete the Functional Living Index-Emesis (FLIE) Questionnaire.|||units on a scale||Full Range|Mean
1444784|NCT00895245|Secondary|Control of Nausea for 120 Hours Following Each Cisplatin Infusion for Multiple Cycles of Therapy as Measured by the Visual Analog Scale|"The visual analog scale ranges from 0-100. 0 is labeled as no nausea and 100 is labeled as nausea as bad as it could be A score of < 25 is considered to indicate no significant nausea. All patients discontinued trial after only one cisplatin infusion."|120 hours following cisplatin infusion||||millimeters||Full Range|Mean
1444785|NCT00895245|Secondary|Rate of Complete Response to Anti-emetic Therapy in the Delayed Setting (25-120 Hours After Cisplatin Infusion)||25-120 hours following cisplatin infusion||||Participants|||Count of Participants
1444786|NCT00895245|Primary|Proportion of Patients With a Complete Response to the Anti-emetic Medication Regimen|Complete response is defined as no emesis or rescue nausea medications needed in the first 120 hours following cisplatin infusion.|120 hours following cisplatin infusion||||Participants|||Count of Participants
1444787|NCT00895232|Secondary|Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)|Quantifies amount of leg movement|Baseline to Day 84|Only subjects who recorded PLM's/Hour at Baseline AND on Day 84.|||PLM's per hour||Standard Deviation|Mean
1444788|NCT00895232|Post-Hoc|Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.|Response is defined as any effect based on a scale of 0 through 4 where 0 = no effect, 1 = mild effect, 2 = moderate effect, 3 = marked effect, and 4 = dramatic effect.|Baseline to Day 84|Only subjects who were evaluated at Baseline AND on Day 84|||percent of participants|||Number
1444789|NCT00895232|Primary|Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale|Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe])|Baseline to Day 84|Only subjects who completed the IRLSSG Rating Scale at baseline AND on Day 84.|||units on a scale||Standard Deviation|Mean
1444790|NCT00895193|Primary|Maximum Flushing Severity Score|Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.|||units on a scale||Standard Deviation|Mean
1444791|NCT00895193|Primary|Duration of Flushing|The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.|||minutes||Standard Deviation|Mean
1444792|NCT00895193|Primary|Time to Flushing|The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.|6 hours after dosing|All participants randomized to the study completed the study. Each arm had 25 participants.|||minutes||Standard Deviation|Mean
1444793|NCT00895193|Primary|Incidence of Flushing|Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.|Hourly for 6 hours on day of dosing|This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study.|||participants|||Number
1444794|NCT00895180|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies (ADA)|Percentage of Participants with Treatment Emergent (TE) anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)|All enrolled participants who had any amount of ramucirumab and evaluable anti-ramucirumab antibodies.|||percentage of participants|||Number
1444795|NCT00895180|Secondary|Percentage of Participants With Anti-Olaratumab Antibodies (ADA)|Percentage of Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.|Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months)|All enrolled participant who had any amount of olaratumab and evaluable anti-olaratumab antibody data.|||percentage of participants|||Number
1444796|NCT00895180|Secondary|Pharmacodynamics (PD) Profiles||Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion|Zero participants were analyzed for pharmacodynamic profile as the plasma collection procedure in this study was not fit for this purpose.||||||
1444797|NCT00895180|Secondary|PK: Cmax and Cmin of Olaratumab||Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion|All enrolled participants who received at least one dose of Olaratumab and had evaluable PK data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
1444798|NCT00895180|Secondary|Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab||Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion|All enrolled participants who received at least one dose of ramucirumab and had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1444799|NCT00895180|Secondary|Median Overall Survival (OS)|OS is the time from the start of treatment to the date of death. Participants who had not expired by the data analysis cutoff date were censored at their last date known to be alive.|Start of Treatment to Death Up To 27 Months|All enrolled participants who received at least one dose of study drug. Participants censored in ramucirumab = 4 and olaratumab = 4.|||Weeks||95% Confidence Interval|Median
1444809|NCT00895037|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.|Baseline until last visit (up to 87 months)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.|||participants|||Number
1444800|NCT00895180|Secondary|Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR])|The pts achievement of both measurement and confirmation criteria for a status of CR, PR or MR based on the modified RANO criteria.CR requires all of the following:complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks (wks);no new lesions;no corticosteroids;and stable or improved clinically.PR requires all of the following:≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 wks;no new lesions;stable or reduced corticosteroid dose;and stable or improved clinically.MR requires ≥ 25% reduction in sum of products of the perpendicular diameters of all measureable enhancing lesions sustained for at least 4 wks and no new lesions or progression of non-measurable lesions. PD is defined by any of these: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions;any new lesion;or clinical deterioration.|Start of Treatment to PD Up To 20 Months|All enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
1444801|NCT00895180|Secondary|Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)|The number of participants who experienced serious adverse events (SAEs) that were considered to be related to ramucirumab or olaratumab. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Start of Treatment to End of Study (Up to 13 Months)|All enrolled participants who received at least one dose of study drug.|||participants|||Number
1444802|NCT00895180|Primary|Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)|PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).|Start of treatment to PD or Death Up To 6 Months|All enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
1444803|NCT00895037|Secondary|Investigator Assessment of Treatment Satisfaction of Participants|Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied.|End of study visit (any time up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.|||participants|||Number
1444804|NCT00895037|Secondary|Participant Assessment of Satisfaction With Treatment Handling|Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied.|End of study visit (any time up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.|||participants|||Number
1444805|NCT00895037|Secondary|Number of Participants With Change From Baseline Status in Days Missed From School or Work|Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.|Baseline until last visit (up to 87 months)|Analysis was performed on effectiveness analysis set. Here, 'N' signifies those participants who were evaluable for this outcome measure. For this outcome measure, data for Refacto AF: intermediate prophylaxis treatment arm could not be analyzed since all participants of this arm were neither working nor school going.|||participants|||Number
1444806|NCT00895037|Secondary|Mean Total Number of Bleeding Episodes Per Year in Participants|Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.|Baseline until last visit (up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' =participants evaluable for this outcome measure.|||bleeding episodes per year||Standard Deviation|Mean
1444807|NCT00895037|Primary|Mean Total Number of Bleeding Episodes in Participants|Participants documented all bleeding episodes in a diary during the study.|Baseline until last visit (up to 87 months)|Effectiveness analysis set =participants registered in study and had at least 1 dose of ReFacto AF documented by participants diary entries. Participant’s registration included confirmation of obtained participant’s informed consent from the physician. Here, 'N' (number of participants analyzed) = participants evaluable for this outcome measure.|||bleeding episodes||Standard Deviation|Mean
1444808|NCT00895037|Primary|Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay|FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.|Baseline until last visit (up to 87 months)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.|||participants|||Number
1444826|NCT00894933|Primary|Safety - Infection That Requires IV Antibiotics or Re-hospitalization|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
1444810|NCT00895037|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline until last visit (up to 87 months)|Safety analysis set included all participants with informed consent and treated with at least 1 dose of ReFacto AF.|||participants|||Number
1444811|NCT00895011|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total scores from questions 1-5 & 15 range from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Error|Least Squares Mean
1444812|NCT00895011|Primary|The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.|||Percentage of Sexual Attempts||Standard Deviation|Least Squares Mean
1444813|NCT00895011|Primary|Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, Week 12|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
1444814|NCT00894933|Primary|Safety - Bladder Neck Contracture|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
1444815|NCT00894933|Primary|Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
1444816|NCT00894933|Primary|Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
1444817|NCT00894933|Primary|Safety - Urinary Retention Requiring Catheterization Post-Device Removal|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
1444818|NCT00894933|Primary|Safety - Creation of a False Passage|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
1444819|NCT00894933|Primary|Safety - Perforation of the Bowel or Bladder|Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.|At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal|Subjects in whom device placement was attempted|||Events|||Number
1444820|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.|At Device placement|Subjects in whom device placement was attempted|||Minutes||Standard Deviation|Mean
1444821|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Total Device Placement Time|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.|At Device placement|Subjects in whom device placement was attempted|||Minutes||Standard Deviation|Mean
1444822|NCT00894933|Secondary|Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts||7-10 and 13 - 15 days post-Device placement|Subjects with successful device placement|||Participants|||Count of Participants
1444823|NCT00894933|Secondary|Intraoperative/Postoperative Parameters - Estimated Blood Loss|To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.|At Device placement|Subjects in whom device placement was attempted|||cc||Standard Deviation|Mean
1444824|NCT00894933|Primary|Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement|Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)|7-21 days post-Device placement||||Participants|||Count of Participants
1444825|NCT00894933|Primary|Successful Device Placement|Defined as the establishment of a water-tight anastomosis immediately post-Device placement.|At Device placement|Subjects in whom device placement was attempted (i.e. treated subjects)|||Participants|||Count of Participants
1444827|NCT00894803|Post-Hoc|Modified Rankin Scale (mRS) of 0-1|"Modified Rankin Scale of 0 or 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of ‘6’, and assigned the “bad” outcome. Also those lost to follow-up were assigned the “bad” outcome.~The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset||||participants|||Number
1444828|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤2 at 90 Days|"Study subjects with an NIH stroke scale score ≤ 2 points at 90 days from treatment onset compared to baseline value, those dead or unable to be evaluated by the NIHSS were assigned the “bad” outcome.~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|90 days from treatment onset||||participants|||Number
1444829|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 2|"Study subjects with an NIH stroke scale score of ≤ 2 at 24 hours from treatment onset, those dead (n=1) or sedated and unable to be evaluated by the NIHSS were assigned the “bad” outcome (n=5).~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 24 hours of treatment onset||||participants|||Number
1444830|NCT00894803|Other Pre-specified|NIH Stroke Scale Score (NIHSS) ≤ 5|"Study subjects with an NIH stroke scale score of ≤ 5 at 2 hours from treatment onset, those sedated and unable to be evaluated by the NIHSS were assigned the “bad” outcome (n=1).~The NIH stroke scale score is scale based on 15 items individually scored between 0-2, 0-3 or 0-4 depending upon the item. The individual items are summed to produce a score between 0 and 42, where 0 indicates no deficit and 42 indicates death."|Within 2 hours of treatment onset||||participants|||Number
1444831|NCT00894803|Secondary|Glasgow Outcome Scale (GOS) of 1|"Glasgow outcome scale score of 1 versus greater than 1. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the “bad” outcome.~The Glasgow Outcome Scale is scored; 1=good recovery, 2=moderately disabled, 3=severely disabled, 4=vegetative survival, 5=dead."|90 days from treatment onset||||participants|||Number
1444832|NCT00894803|Secondary|Barthel Index ≥ 95|"Barthel index score of ≥ 95. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days and those lost to follow-up were assigned the “bad” outcome.~The Barthel index is a score comprised of 10 individual items. Each item may be scored 0, 5, 10 or 15; not all items use the full range of 4 possible values. The individual items are summed to produce a total score between 0 and 100; where 0 is inferior performance and 100 is optimal. A score of ≥ 95 is usually considered excellent."|90 days from treatment onset||||participants|||Number
1444833|NCT00894803|Post-Hoc|Death Due to Stroke Within 90 Days of Treatment Onset|Death due to stroke within 90 days of treatment onset. Classified by blinded clinical investigators|Within 90 days of treatment onset||||participants|||Number
1444834|NCT00894803|Post-Hoc|Death Within 90 Days of Treatment Onset|Death due to any cause within 90 days of treatment onset|Within 90 days of treatment onset||||participants|||Number
1444835|NCT00894803|Other Pre-specified|Death Due to Stroke Within 7 Days of Treatment Onset|Death due to stroke within 7 days of treatment onset. Classified by blinded clinical investigators|Within 7 days of treatment onset||||participants|||Number
1444836|NCT00894803|Other Pre-specified|Death Within 7 Days of Treatment Onset|Death due to any cause within 7 days of treatment onset|Within 7 days of treatment onset||||participants|||Number
1444837|NCT00894803|Other Pre-specified|Asymptomatic Intracranial Hemorrhage (asICH) Within 7 Days of Treatment Onset|Any ICH observed on CT by the study site neuroradiologist and the independent study neuroradiologist; the central reader. The ICH would not be related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH,where judgment of significant neurological decline was made by the local clinical investigator. A third independent reader will make the final determination if there is disagreement between the treating investigator and the central reader|Within 7 days of treatment onset||||participants|||Number
1444838|NCT00894803|Other Pre-specified|Symptomatic Intracranial Hemorrhage (sICH) Within 7 Days of Treatment Onset|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 7 days of treatment onset||||participants|||Number
1444839|NCT00894803|Other Pre-specified|Serious Systemic Bleeding|Incidence of serious systemic bleeding defined as requiring transfusion of 2 or more units of packed red blood cells.|Within 7 days of treatment onset||||participants|||Number
1444840|NCT00894803|Primary|Modified Rankin Scale (mRS) Score <1 or Return to mRS Baseline|"Primary efficacy outcome measure - Modified Rankin Scale of 0 or 1 or return to the pre-stroke value at baseline or better. The scale was performed by a study site investigator not directly involved with acute treatment of the patient. Study subjects dead at 90 days were given a value of ‘6’, and assigned the “bad” outcome. Also those lost to follow-up were assigned the “bad” outcome.~The Modified Rankin Score (mRS) is a 6 point ordinal scale, measuring functional status. 0 (no symptoms at all), 5 (severe disability; bedridden, incontinent, and requiring constant nursing care)."|90 days from treatment onset||||participants|||Number
1444841|NCT00894803|Primary|Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours of Treatment Onset|Primary safety outcome measure - Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|Within 36 hours of initiation of therapy||||participants|||Number
1444877|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 12 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug.|||Participants|||Number
1444842|NCT00894790|Secondary|Change From Baseline in Participant's Responses to Neck Disability Index (NDI)|NDI: participant-administered 10-item questionnaire to assess how neck pain affects 10 activities of daily living (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) with six potential responses, each describing a greater degree of disability (0 = no disability to 5 = total disability). Total score calculated by adding individual item scores for evaluation scheme: 0-5 = No disability; 6-15 = Mild disability; 16-25 = Moderate disability; 26-35 = Severe disability; Above 35 = Complete disability.|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
1444843|NCT00894790|Secondary|Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire|Two part questionnaire; First part assessed symptoms: feeling of gas/air in stomach or feeling bloated, nausea, vomiting, excessive burping or belching and worsening of heartburn or acid reflux. Participant rated Yes/No experienced, for how many days per week (1 through 7) for each symptom and how bothered they were (not at all, somewhat or very). Second part assessed the presence of general abdominal pain (steady, dull, sharp/shooting, always present or comes and goes), the number of days they experienced it (1 through 7) and how bothered they were by it (not at all, somewhat, very).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
1444844|NCT00894790|Secondary|Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores|m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
1444845|NCT00894790|Secondary|Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score|m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours.|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
1444846|NCT00894790|Secondary|Change From Baseline on Physician’s Global Assessment of Cervical Injury|Physician rated responses evaluating the overall condition of participant's cervical injury at that time. Response option ranged from 1 (Very mild - Very mild signs and symptoms of cervical injury) to 5 (Very Severe - Very severe signs and symptoms of cervical injury).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
1444847|NCT00894790|Secondary|Change From Baseline in Patient Global Assessment of Cervical Injury|Participant rated responses to question: Considering all the ways your cervical injury affects you, how are you doing today? Response options ranged from 1 (Very good - No symptoms and no limitation of normal activities) to 5 (Very Poor - Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Days 7, 14|Data not analyzed due to study termination.|||units on a scale||Standard Deviation|Mean
1444848|NCT00894790|Secondary|Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain) with at least a 20 mm improvement.|Baseline, Days 7, 14|Data not analyzed due to study termination.|||Percentage of participants|||Number
1444849|NCT00894790|Secondary|Change From Baseline on VAS-pain at Day 3 and Day 14|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Days 3, 14|Data not analyzed due to study termination.|||mm||Standard Deviation|Mean
1444850|NCT00894790|Primary|Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain|Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).|Baseline, Day 7|Data not analyzed due to study termination.|||mm||Standard Deviation|Mean
1444851|NCT00894699|Primary|Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4)|The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.|4 hour study period|ITT population were those patients that took at least one dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1444852|NCT00894647|Secondary|Number of Participants With Any Post-baseline Local Skin Reactions (LSRs)|"LSRs were assessed independently from AEs. The frequency and percentage of subjects, as well as the mean (SD) and median score for severity (none=0, mild=1, moderate=2, and severe=3), were summarized by treatment group and by visit for the following LSRs: erythema, edema, weeping/exudates, flaking/ scaling/dryness, and scabbing/crusting. Erosion and ulceration were also evaluated (none=0, erosion=1, and ulceration=2). A score of greater than 0 for the specified LSR was considered a treatment site reaction."|Weeks 2, 4, 6, 10, 14, 20, and 26|Safety population: all randomized subjects were presumed to have applied at least one application of study medication and were included in the safety population. This population was used for all safety analyses. Subjects were analyzed as treated.|||participants|||Number
1444853|NCT00894647|Secondary|Percent of Subjects With Complete Clearance|Proportion of subjects who achieved complete clearance of all AK lesions, cryosurgery-treated AK lesions, and non cryosurgery-treated AK lesions from baseline to Week 26/EOS in the ITT population.|Week 26|Intent to treat (ITT) population, last observation carried forward (LOCF)|||percentage of participants||95% Confidence Interval|Number
1444854|NCT00894647|Primary|Change From Baseline in Percentage of Lesion Count|The primary efficacy endpoint was a comparison between the active and placebo treatment groups of percent change from baseline in the total AK lesion count at Week 26. All AK lesions on the face were included in the analysis—treated and untreated AK lesions at baseline (defined as the AK lesion count just prior to cryosurgery) and new lesions that appeared post-baseline.|Week 26|Intent to treat population, Last Observation Carried Forward (LOCF)|||percentage of lesion count||Standard Deviation|Mean
1444933|NCT00893971|Primary|Heart Rate Change From Baseline|Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)|12 hours|All subjects in the Safety Population that had a valid measurement for the parameter|||bpm||Full Range|Mean
1448653|NCT00860457|Secondary|Number of Patients With Adverse Events|Adverse events were evaluated as per the NCI Criteria for Adverse Events, version 3.0.|3 years|||||||
1444855|NCT00894556|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.|||attacks|Evaluable Attacks||Number
1444856|NCT00894556|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|The FAS population included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack the participant must have administered study treatment for this attack and must have had both a baseline severity measurement and at least one post-dose efficacy measurement prior to or including the 2-hour time point.|||attacks|Evaluable Attacks||Number
1444857|NCT00894543|Secondary|Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries|Change in daily hot flash bother between baseline & week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|"Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).~Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment."|||Scores on a scale||95% Confidence Interval|Mean
1444858|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash severity between baseline & week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN).|week 8 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).|||Scores on a scale||95% Confidence Interval|Mean
1444859|NCT00894543|Primary|Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|"Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).|||Scores on a scale||95% Confidence Interval|Mean
1444860|NCT00894543|Secondary|Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries|"Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|week 4 minus baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).|||Scores on a scale||95% Confidence Interval|Mean
1444861|NCT00894543|Primary|Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries|"Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adapted from the Study of Women Across the Nation (SWAN).|||Scores on a scale||95% Confidence Interval|Mean
1444862|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit.|week 8 minus baseline||||Hot flashes/day||95% Confidence Interval|Mean
1444863|NCT00894543|Primary|Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries|Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit.|week 4 minus baseline||||Hot flashes/day||95% Confidence Interval|Mean
1444934|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study Hemoglobin|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||g/L||Full Range|Mean
1444935|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||(10^9 cells/L)||Full Range|Mean
1444864|NCT00894543|Secondary|Daily Hot Flash Bother, Recorded on Daily Diaries|"Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)."|Baseline|Twice daily rating for bother using response categories from the Study of Women Across the Nation (SWAN): 1 (not at all), 2 (very little), 3 (moderately), 4 (a lot).|||Scores on a scale||95% Confidence Interval|Mean
1444865|NCT00894543|Primary|Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries|Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks.|Baseline||||Hot flashes/day||95% Confidence Interval|Mean
1444866|NCT00894517|Secondary|Change From Baseline in Normal Sperm Morphology|Sperm Morphology was evaluated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Normal sperm morphology was assessed from slide smears sent to a central reading facility. A positive change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Percent||Standard Deviation|Mean
1444867|NCT00894517|Secondary|Change From Baseline in Total Sperm Motility|Sperm motility was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Sperm motility was assessed using the CELL-VU chamber and was scored according to the World Health Organization criteria for sperm progression and motility. A total of at least 200 motile and immotile sperm were counted. A percent was determined by the calculation of motile sperm/total sperm count. A negative change from Baseline indicated a worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Percent||Standard Deviation|Mean
1444868|NCT00894517|Secondary|Change From Baseline in Ejaculatory Volume|Ejaculatory volume was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume was measured using a standard pipette (measuring device). A negative change from Baseline indicated worsening.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||milliliters (mL)||Standard Deviation|Mean
1444869|NCT00894517|Secondary|Change From Baseline in Log Transformed Sperm Concentration|Sperm concentration was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Collected sperm samples were assessed using a CELL-VU® count chamber. The total number of sperm per 100 boxes on the chamber grid were counted. Sperm Concentration = total number of sperm counted in 100 boxes × dilution factor / 1 × 10^6 and is reported in millions per milliliter. Log transformation of the sperm concentration was used for analysis . The log transformed sperm concentration data has no units. A negative change from Baseline indicated a lower sperm concentration (worsening).|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Unitless||Standard Deviation|Mean
1444870|NCT00894517|Primary|Percent Change in Total Sperm Count Per Ejaculate|Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all randomized participants who received treatment.|||Percent change||Standard Deviation|Mean
1444871|NCT00894504|Secondary|Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab|Median PFS (95% CI), months, reported by biomarker expression/mutation status for: EGFR, p53, PTEN, PIK3CA, KRAS|18 months|Excludes patients in the following categories due to insufficient data: PTEN status unknown, PIK3CA Status unknown and KRAS no mutation|||months||95% Confidence Interval|Median
1444872|NCT00894504|Secondary|Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity|Assessments made through analysis of treatment-related adverse events and serious adverse events|every 6 weeks until discontinuation of treatment, expected average of 18 months||||participants|||Number
1444873|NCT00894504|Secondary|Objective Response Rate and Clinical Benefit Rate|Estimated as the proportion of subjects who meet the criteria for complete or partial response (CR or PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 - for target lesions assessed by MRI: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions.|every 6 weeks until treatment discontinuation|All evaluable patients per RECIST v 1.1|||Participants|||Number
1444874|NCT00894504|Primary|Progression-free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions|every 6 weeks until treatment discontinuation||||Months||95% Confidence Interval|Median
1444875|NCT00894465|Secondary|Anxiety Score From the State-Trait Anxiety Inventory|The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. This questionnaire was used to evaluate the anxiety level of the parents of the children who randomized to versed or placebo.|At the time of the procedure||||units on a scale||Standard Deviation|Mean
1444876|NCT00894465|Primary|Anxiety Score From the Modified Yale Preoperative Anxiety Scale|The modified Yale preoperative scale consists of 5 categories (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Four of the five categories are scored between 1-4 points and one of the categories is scored from 1-6 points. The scores are divided by their number of possible points in their respective category and multiplied by 20 to get the final anxiety score which ranges from 20 to 100. Low numbers represent low anxiety and higher numbers represent high anxiety.|Waiting room, before catheterization, and after catheterization||||units on a scale||Standard Deviation|Mean
1444938|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||µmol/L||Full Range|Mean
1444878|NCT00894387|Secondary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Level at 1 Month, 6 Months, and 12 Months|The reported Least square means, and Confidential Interval were from a repeated measures model on log transformed NT-proBNP data containing treatment, visit, and region as factors, log baseline NT-proBNP as a continuous covariate and treatment by visit and visit by log baseline NT-proBNP as interaction terms.|Baseline, 1 month, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of study drug. 'n' in each category indicates patients with assessable date at baseline and each corresponding time point.|||pg/mL||95% Confidence Interval|Least Squares Mean
1444879|NCT00894387|Primary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.|6 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.|||Participants|||Number
1444880|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With All-cause Mortality Hospitalized for an AHF Event Within 12 Months||12 months|Full ananlysis set included all randomized patients who had at least one dose of study drug.|||Participants|||Number
1444881|NCT00894387|Secondary|Time to Event Analysis: Number of Patients With First Cardiovascular (CV) Event Hospitalized for an Acute Heart Faliure (AHF) Event Within 6 Months|A cardiovascular event defined as CV death, heart faliure re-hospitalization, non-fatal myocardial infarction (MI), nonfatal stroke, sudden death with resuscitation.|6 months|Full analysis set included all randomized patients who had taken at least one dose of drug.|||Participants|||Number
1444882|NCT00894387|Secondary|Change From Baseline in the Clinical Summary Score to 1 Month, 6 Months and 12 Months|Symptom reduction and reduction in physical limitations was assessed using the clinical summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a self-administered questionnaire and contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Health-Related Quality of Life (QoL), including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Each scale score was calculated as the mean of its item scores and transformed to a 0–100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents death. A positive change in score from baseline indicates an improvement.|Baseline, 1 months, 6 months and 12 months|Full analysis set included all randomized patients who had taken at least one dose of drug. 'n' in each category indicates patients with assessable data both at baseline and corresponding time points.|||units on a scale||Standard Error|Least Squares Mean
1444883|NCT00894387|Secondary|Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months|Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.|12 months|Full analysis set (FAS) consisted of randomized patients who had received at least one dose of study drug.|||Participants|||Number
1444884|NCT00894361|Primary|Knee Postoperative Range of Motion (ROM) at 2 Years|range of motion of the knee postoperatively at 2 years|2 years||||degrees||Standard Deviation|Mean
1444885|NCT00894361|Secondary|Survival of the Implants to Subject Death or Implant Removal||10 or more years|||||||
1444886|NCT00894322|Primary|Time to Maximum Concentration (Tmax) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Tmax was measured in hours (h). Exenatide was measured using a validated ELISA. Tmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||hours||Standard Error|Geometric Mean
1444887|NCT00894322|Primary|Maximum Concentration (Cmax) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. Cmax was measured in pg/mL. Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). Cmax summarized at 0-6 h at Week 10, 0-168 h at Weeks 10-11, and 0-tlast at Weeks 10-12. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10, Weeks 10-11, Weeks 10-12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||pg/mL||Standard Error|Geometric Mean
1444896|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Heart Rate in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Heart rate was measured in beats per minute (bpm). In Cohort 2, sitting heart rates were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12||||bpm||Standard Deviation|Mean
1444936|NCT00893971|Primary|Hematology Change From Baseline|Hematology assessments taken throughout the study Hematocrit|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All subjects in the Safety Population that had a valid measurement for the parameter|||% of Red Blood Cells in the blood||Full Range|Mean
1444888|NCT00894322|Primary|Average Exenatide Concentration (Cave) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) and Cave(0-tlast) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h), and AUC (0-tlast), respectively. Cave was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10 - Week 11; Week 10 - Week 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||pg/mL||Standard Error|Geometric Mean
1444889|NCT00894322|Primary|Area Under the Curve (AUC) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population|Cohort 2: Blood samples for the assessment of plasma exenatide were collected on Day 1, Weeks 2, 4, 6, 8, and 10. At Week 10, blood samples were collected at time = -15, 60, 90, 120, 180, 240, and 360 minutes relative to study medication injection at time = 0. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-6h) measured at Week 10, AUC (0-168h) steady state measured between Weeks 10 and 11, and AUC (0-tlast) for time interval between Weeks 10 and 12 (approximately336 hours) are presented below. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Week 10-11; Weeks 10 - 12|PK evaluable population was analyzed. In categories below, n = number of ITT participants with PK evaluable data. Note: Placebo-treated participants not included in this analysis.|||pg*hr/mL||Standard Error|Geometric Mean
1444890|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Fasting Plasma Glucose in Participants With Diabetes (Cohort 2) for the ITT Population|Baseline was the last measurement at the screening visit. Fasting plasma glucose (FPG) was measured at screening, Day 1, Weeks 2, 4, 6, 8, 12, or early termination and reported in milligrams per deciliter (mg/dL).|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only participants in Cohort 2 were evaluated for this Outcome Measure.|||mg/dL||Standard Error|Least Squares Mean
1444891|NCT00894322|Secondary|Mean Change From Baseline at Week 12 in Body Weight in Participants With Diabetes (Cohort 2) in the ITT Population|Body weight was measured in kilograms (kg). Baseline was Day 1, last measurement prior to first dose of study drug. Body weight was measured at screening, Day 1, Weeks 4, 8, 12 or early termination and the LOCF approach was applied to estimate missing value at each post baseline timepoint.|Baseline, Week 12|ITT population included all participants treated with at least one dose of study drug. Only Cohort 2 was analyzed for this outcome measure.|||kg||Standard Error|Least Squares Mean
1444892|NCT00894322|Secondary|Number of Participants Achieving HbA1c Less Than Equal to (<=) 6.5% and Less Than (<) 7% at Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. LOCF was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Week 12|ITT population included all participants treated with at least one dose of study drug. Only those ITT participants in Cohort 2 were analyzed.|||participants|||Number
1444893|NCT00894322|Secondary|Least Square Mean Change From Baseline in Hemoglobin A1c (HbA1c) to Week 12 in Participants With Diabetes (Cohort 2) in the ITT Population|HbA1c was measured as a percent of hemoglobin at screening, Day 1, Weeks 4, 8, 12 or early termination. Last observation carried forward (LOCF) was applied to estimate missing values at post baseline timepoints. Baseline=Day 1, last measurement prior to first dose of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug. This analysis was only done in Cohort 2 so the ITT population of Cohort 2 was available for analysis.|||Percent of hemoglobin||Standard Error|Least Squares Mean
1444894|NCT00894322|Primary|Antibody Titers for Participants With Treatment Emergent Positive Antibodies to Exenatide in Participants Who Received Exenatide in Cohorts 1 and 2|Serum titers of antibodies to exenatide were evaluated using a validated enzyme-linked immunosorbent assay (Covance Method No. ELISA-0308). Positive antibody to exenatide titer: observed at the indicated visit following a negative or missing titer at baseline, or a positive titer that has increased by at least 3 dilutions at the indicated visit from a detectable baseline. Baseline=Day 1. Negative titers were assigned a value of 1 in order to calculate geometric mean. Geometric mean of reportable titers, by study week, are presented below.|Day 1 to Week 12|Only participants who received exenatide were analyzed (no placebo-treated participants were included). N=number of participants in each treatment at each visit and n= number of participants with reportable titers at the visit. Last visit=last visit with reportable titers.|||Reportable Titers||Standard Error|Geometric Mean
1444895|NCT00894322|Primary|Number of Participants With Hematology and Serum Chemistry Laboratory Values of Potential Clinical Importance in Cohorts 1 and 2 in ITT Population|Abbreviations: Upper Limit of Normal (ULN); milligram per deciliter (mg/dL); units per liter (U/L); micro liters (µL); creatine kinase (CK); gamma-glutamyltransferase (G-GT). Normal ranges = Hematocrit: 40.6-52.3% (male), 35.3-47.0 (female); Platelets 155-361*10^3/µL(male/female); Calcium: 8.6-10.4 mg/dL (male/female); CK: 43-350 U/L (male), 28-207 U/L (female); G-GT: 7-62 U/L (male/female); Glucose 73-105 mg/dL (male/female); Lipase 14-70 U/L (male/female); Uric acid: 3.5-7.8 mg/dL (male), 2.3-5.9 mg/dL (female). Blood samples for laboratories were collected at screening, Day 1, Weeks 4, 8, 12 or early termination. Value for potential clinical importance is presented in each category presented below.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.|||participants|||Number
1444920|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||pg/mL||Standard Deviation|Mean
1448681|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 6|DBP < 90 mmHg|week 6|FAS (LOCF)|||participants|||Number
1444897|NCT00894322|Primary|Mean Change From Baseline to End of Study in Sitting Diastolic and Systolic Blood Pressure in Cohorts 1 and 2 in ITT Population|In Cohort 1, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-11 (Visits 3-13), Week 12 (Visit 14), and at early termination. Blood pressures (diastolic and systolic) were measured in millimeters of mercury (mmHg). In Cohort 2, sitting blood pressures were obtained at Screening (Visit 1), Day 1 (Visit 2), Weeks 1-10 (Visits 3-12), Week 11 (Visit 15), Week 12 (Visit 16) and at early termination. Baseline was defined as last measurement prior to first injection of study drug.|Day 1 to Week 12|ITT population included all participants treated with at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1444898|NCT00894322|Secondary|Average Exenatide Concentration (Cave) of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single dose, a single blood sample was collected for assessment of exenatide concentrations. Cave(0-168h) was the time-weighted mean concentration over the sampling period from time x to time y corresponding to AUC (0-168h) and was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.|||pg/mL||Standard Error|Geometric Mean
1444899|NCT00894322|Secondary|AUC (0 Hour to 168 Hour) for 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC (0-168 h) data represents average concentration rather than maximum concentration. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y and measured in pg*h/mL. PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements (not < LLOQ) from Day 1 to Week 12 and had reliable PK data.|Day 1 to Week 1|PK evaluable population.|||pg*h/mL||Standard Error|Geometric Mean
1444900|NCT00894322|Primary|Number of Participants With Concomitant Medications in Cohort 1 and Cohort 2 in ITT Population|Concomitant medications are defined as those medications received on or after the date of the first injection on Day 1, including prior medications that continued past Day 1 and new concomitant medications. Participants may be counted in more than one medication class and no more than once in each class. Categories by Anatomical Therapeutic Chemical (ATC) classification using the World Health Organization (WHO) Drug Dictionary version C1, 01 March 2009. As per protocol, all participants in Cohort 1 could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide.|Day 1 to 12 weeks|ITT population included all participants treated with at least one dose of study drug.|||participants|||Number
1444901|NCT00894322|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Injection Site TEAEs, Serious Adverse Events (SAEs), Deaths, and Withdrawals Due to AEs in Cohort 1 and Cohort 2 in Intent to Treat (ITT) Population|Treatment emergent (TE)=occurs during or after treatment with study drug. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Participants experiencing multiple episodes of a given AE are counted once. Injection site AEs: adverse events that existed prior to Day 1 and worsened after the first administration at Day 1, or occurred after the first administration at Day 1 through Week 12, or after Study Termination if considered by investigator to be clinically significant.|Day 1 to Week12|ITT population included all participants treated with at least one dose of study drug.|||participants|||Number
1444902|NCT00894322|Primary|Time to Maximum Concentration (Tmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time(t) = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 an the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Tmax was measured in hours and Tmax (0-8h) and (0-tlast) are presented below. Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] and had reliable PK data.|Day 1, Week 12|PK evaluable population. n=number of participants who had reliable PK data available to be evaluated.|||hours||Standard Error|Geometric Mean
1444903|NCT00894322|Primary|Maximum Concentration (Cmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. Cmax was measured in picograms per milliliter (pg/mL). Exenatide concentration was measured using a validated enzyme-linked immunosorbent assay (ELISA). PK evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 for the evaluation of the PK characteristics of plasma exenatide and had reliable PK data. Cmax (0-8h) and (0-tlast) are presented below.|Day 1, Week 12|PK evaluable population.|||pg/mL||Standard Error|Geometric Mean
1444921|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (t1/2)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
1444937|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All patients in the Safety Population that had a valid measurement for the parameter|||U/L||Full Range|Mean
1444904|NCT00894322|Primary|Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population|Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC was measured in picograms * hours per milliliter (pg*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (ELISA). AUC calculated using linear trapezoidal method from time x to time y; AUC (0-8h) and (0-tlast) are presented below. Pharmacokinetic (PK) evaluable population consisted of all ITT participants who had at least 4 detectable plasma exenatide measurements [not less than (<) lower limits of quantification (LLOQ)] from Day 1 to Week 12 and had reliable PK data.|Day 1, Week 12|PK evaluable population was analyzed. n in categories below = number of ITT participants with PK evaluable data.|||pg*h/mL||Standard Error|Geometric Mean
1444905|NCT00894244|Primary|The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)|The documented variable was shrinkage length in millimeters as measured by the same straight ruler used throughout the experimentation. Measurements were taken immediately following treatment and thirty days following the last treatment|immediately following treatment and 30 days after last treatment||||millimeters||95% Confidence Interval|Number
1444906|NCT00894166|Secondary|Continuous Abstinence From Smoking at 6 Months Post Quit.||continuous abstinence at 6 months post quit day||||percentage of subjects|||Number
1444907|NCT00894166|Secondary|Abstinence (7 Days) at 6 Months.||point abstinence (7 days) at 6 months post-quit date||||percentage of subjects|||Number
1444908|NCT00894166|Primary|Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment)|A self report of no cigarettes smoked confirmed by expired air carbon monoxide of <=10ppm was the criterion for abstinence.|weeks 8-11 after quit date|All participants were included in the analyses except those dropping out prior to randomization points, those censored for taking contraindicated medications or failing to meet other inclusion criteria, and one death having no apparent relationship to treatment.|||percentage of subjects abstinent||95% Confidence Interval|Number
1444909|NCT00894127|Primary|Determine the Clinical Sensitivity and Specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay Using Sputum Specimens From Two Cohorts of Participants and Estimate the Required Sample Size to Finalize a Protocol for a Pivotal Study.|"Various measurements were taken to report the validity of the findings. Sensitivity in this study was defined as the percentage of tumor cells that were positively identified. Specificity was the percentage of true positive signals and accuracy calculated as the percentage of those patients identified as having cancer.~Testing for the study was performed at multiple locations to assess the efficacy of the CyPath Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the study and assigned to one of two cohorts (smoker with clear Low dose CT scan or high-risk normals, and lung cancer confirmed by pathology or cancer)."|March 2011||||percentage|||Number
1444910|NCT00893997|Primary|Number of Patients With Clinical Response|Clinical response based on the International Working Group (IWG) Response Criteria in myelodysplastic syndromes (MDS): 'Complete Response' or Hematologic Improvement' and 'No Clinical Response'. Clinical responses as assessed by standard criteria with bone marrow biopsy, cytogenetic studies (standard chromosome banding) and molecular studies 3 weeks after the last vaccination.|At 29 weeks|Analysis on patients treated; study terminated early.|||participants|||Number
1444911|NCT00893997|Primary|Patient Immunologic Response|Patients assessed after 4th vaccination for immunologic response categorized as 'Immunologic-Responders' or 'Non-Responders.' Immune response defined as an increase of ≥ 0.5 PR1-HLA-A2 tetramer cells/μl compared to the pre study absolute PR1-HLA-A2 tetramer cells/μl. Time period 29 weeks after study entry, with week 0 corresponding to 1st injection, and 8th injection thus being given at week 25, 29 weeks corresponds to 13 weeks after receipt of a 4th injection.|29 weeks|Analysis on patients treated; study terminated early.|||participants|||Number
1444912|NCT00893971|Primary|Serum Potassium Change From Baseline||12 hours|All subjects in the Safety Population|||mmol/L||Full Range|Median
1444913|NCT00893971|Secondary|Plasma Formoterol PK Parameters (ke)|Pharmacokinetic parameters for plasma formoterol ke|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||1/h||Standard Deviation|Mean
1444914|NCT00893971|Secondary|Plasma Formoterol PK Parameters (Cmax)|Pharmacokinetic parameters for plasma formoterol Cmax|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||pg/mL||Standard Deviation|Mean
1444915|NCT00893971|Secondary|Plasma Formoterol PK Parameters (t1/2)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
1444916|NCT00893971|Secondary|Plasma Formoterol PK Parameters (Tmax)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h||Standard Deviation|Mean
1444917|NCT00893971|Secondary|Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
1444918|NCT00893971|Secondary|Plasma Formoterol PK Parameters|Various pharmacokinetic parameters for plasma formoterol|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||h*pg/mL||Standard Deviation|Mean
1444919|NCT00893971|Secondary|Plasma Glycopyrrolate PK Parameters (ke)|Various pharmacokinetic parameters for plasma glycopyrrolate|Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose|Subjects with an evaluable profile for this analyte|||1/h||Standard Deviation|Mean
1448682|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 4|DBP < 90 mmHg|week 4|FAS (LOCF)|||participants|||Number
1444939|NCT00893971|Primary|Blood Chemistry Change From Baseline|Series of 11 blood chemistries assessed throughout the study|24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects|All patients in the Safety Population that had a valid measurement for the parameter|||mmol/L||Full Range|Mean
1444940|NCT00893971|Primary|Symptoms of Tremor|Number of participants reporting tremor at 12 hours post-dose|12 hours|All subjects in the Safety Population|||Participants|||Number
1444941|NCT00893971|Primary|Symptoms of Dry Mouth|Number of participants reporting dry mouth at 12 hours post-dose|12 hours|All subjects in the Safety Population|||Participants|||Number
1444942|NCT00893789|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint (Last Postbaseline Observation, up to Week 12)|Number of participants with shifts from normal/abnormal physical examination findings at baseline (BL) to (→) normal/abnormal findings at endpoint (EP, defined as last postbaseline observation, up to Week 12). Shifts (normal and abnormal) from baseline to endpoint are summarized using participant counts for each physical examination category. A newly diagnosed finding was defined as being normal or missing at baseline and abnormal at least once during the study. Any physical examination finding that was judged by the investigator as a clinically significant change (worsening) compared to a baseline value was considered an adverse event. HEENT=head, eyes, ears, nose, throat.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|For each category, only participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.|||participants|||Number
1444943|NCT00893789|Secondary|Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|Number of participants with shifts from normal/abnormal 12-lead ECG findings at baseline (BL) to (→) normal/abnormal findings overall are presented. For overall, the worst postbaseline finding (the abnormal finding if there are both normal and abnormal findings) for the participant between baseline and endpoint (defined as last postbaseline observation, up to Week 12) is summarized. Shifts (normal and abnormal) from baseline to overall are summarized using participant counts. Any ECG finding that was judged by the investigator as a clinically meaningful change (worsening) compared to baseline was recorded as an adverse event.|Baseline through Endpoint (last postbaseline observation, up to Week 12)|Participants in the Safety Analysis Set with a baseline and postbaseline measurement are summarized.|||participants|||Number
1444944|NCT00893789|Secondary|Number of Participants With Notable Blood Pressure Values Per World Health Organization Criteria|Criteria for World Health Organization (WHO) notable blood pressure (BP) values: systolic blood pressure, ≥140 mm Hg plus increase of ≥10% from baseline; diastolic blood pressure, ≥90 mm Hg plus increase of ≥10% from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
1444945|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Vital Sign Values|Criteria for clinically significant abnormal vital signs values: heart rate, ≤50 beats per minute (bpm) and decrease from baseline of ≥15 bpm; sitting systolic blood pressure, ≤90 mm Hg and decrease from baseline of ≥20 mm Hg; sitting diastolic blood pressure, ≤50 mm Hg and decrease from baseline of ≥15 mm Hg.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
1444946|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Urinalysis Values|Participants with at least one clinically significant postbaseline urinalysis abnormality, specifically presented is blood (hemoglobin) in urine >=2 units increase from baseline.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
1444947|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Hematology Values|Normal ranges for hematology values: white blood cell (WBC) count, 3.8 - 10.7 x 10^9/L; absolute neutrophil count (ANC), 1.96 - 7.23 x 10^9/L. Participants may have had more than one clinically significant abnormal value.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
1444948|NCT00893789|Secondary|Number of Participants With Clinically Significant Abnormal Postbaseline Serum Chemistry Values|Normal ranges for serum chemistry values: blood urea nitrogen (BUN), 1.43 - 8.57 mmol/L; uric acid, 124.91 - 493.68 μmol/L; aspartate aminotransferase (AST), 11 - 36 U/L; gamma-glutamyl transpeptidase (GGT), 10 - 61 U/L; total bilirubin, 3.42 - 20.52 μmol/L.|Baseline, last postbaseline observation up to Week 12|Participants in the Safety Analysis Set with a baseline and postbaseline measurement.|||participants|||Number
1444949|NCT00893789|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Withdrawals Due to AEs|AE=any untoward medical occurrence in a patient that develops or worsens in severity during the conduct of the clinical study of a pharmaceutical product and does not necessarily have a causal relationship to the study drug. SAE=any AE that resulted in any of the following: death; a life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly or birth defect; an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-related AEs=definite, probable, possible, or missing relationship. Protocol-defined AEs=treatment-emergent adverse events associated with skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, depression, psychosis (including hypomanic or manic episode), and seizure or suspected seizure were considered to be of potential clinical importance.|Screening through Week 12|Safety Analysis Set (all participants who received 1 or more doses of study drug).|||participants|||Number
1444950|NCT00893789|Secondary|Concomitant Medication Usage In ≥5% of Participants Throughout the Study|Therapeutic classification of concomitant medications used by ≥5% of participants throughout the study. Participants are counted only once in each therapeutic class category. Medications were included in the table if the proportion of participants in the combined armodafinil treatment group was ≥5%.|Screening through Week 12|All randomized participants|||participants|||Number
1444988|NCT00893074|Primary|"Subjective Drug Effect After Smoked Marijuana"|Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect|Day 5 of the Dronabinol abstinence period||||mm of subjective drug effect||Standard Error|Mean
1444951|NCT00893789|Secondary|Plasma Concentrations of Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) at Weeks 4, 8, and 12 (or Last Postbaseline Observation Up to Week 12)|To evaluate the impact of treatment with armodafinil on the pharmacokinetics of selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) (as appropriate), plasma concentrations at weeks 4, 8, and 12 (or last postbaseline observation) were to be assessed.|Weeks 4, 8, and 12 (or last postbaseline observation, up to Week 12)|Due to the limited samples available for measurement of concentrations of antidepressants in the study, the plasma concentrations of antidepressants were not measured. The planned pharmacokinetic evaluation of the impact of armodafinil treatment on the pharmacokinetics of selective antidepressants was not conducted.||||||
1444952|NCT00893789|Secondary|Change From Baseline in the Total Sleep Time As Assessed by Nocturnal Polysomnography (NPSG) at Weeks 2, 4, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|NPSG continuously records normal and abnormal physiological activity during an entire night. It documents the adequacy of sleep, including the frequency, duration, and total amounts of stage 1-2, stage 3-4 (slow wave sleep), and rapid eye movement (REM) sleep.|Baseline, Weeks 2, 4, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Safety Analysis Set (all participants who received 1 or more doses of study drug); n=number of participants with data at given time point.|||minutes||Standard Deviation|Mean
1444953|NCT00893789|Secondary|Change From Baseline in the Total Score From the Self-Reported Hamilton Depression Rating Scale, 6 Item Version (S-HAM-D6) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to 12 Weeks)|"The self-reported S-HAM-D6 is a validated scale developed from the core depressive items of the 17 Item Hamilton Depression Inventory (HAM-D17). The HAM-D6 (Items 1, 2, 7, 8, 10, 13 from the 17-item HAMD) evaluates core symptoms of Major Depressive Disorder (MDD). The assessment consists of 6 items representing depressed mood, guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). Total scores range from 0 (normal) to 22 (severe). Scores greater than 12 indicate moderate to severe depression and scores less than 12 indicate mild depression."|Baseline, Weeks 2, 4, 8, 12, and Endpoint (last postbaseline observation up to 12 weeks)|Participants in the Safety Analysis Set (participants who received 1 or more doses of study drug) with a baseline S-HAM-D6 measurement; n=number of participants with nonmissing data at given time point.|||units on a scale||Standard Deviation|Mean
1444954|NCT00893789|Secondary|"Percentage of Participants Answering No to All Questions on the Columbia-Suicide Severity Rating Scale Since Last Visit Version (C-SSRS SLV) at Weeks 2, 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)"|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors since last visit (SLV). The number of participants answering 'no' to all 9 yes/no questions about suicidal behaviors, ideations, and acts are presented. Questions included the presence of the following: a wish to be dead; nonspecific active suicidal thoughts; actual suicide attempt; non-suicidal self-injurious behavior; interrupted attempt; aborted attempt; suicidal behavior; preparatory suicidal acts or behavior; and completed suicide.|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Safety analysis set (all participants who received 1 or more doses of study drug); n=all participants with a nonmissing value at given time point.|||percentage of participants|||Number
1444955|NCT00893789|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|The patient’s evaluation of excessive daytime sleepiness was measured by the ESS. The ESS score is based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflects a patient’s propensity to fall asleep in those situations. The ESS score is derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS range from 0 to 24, with a higher score indicating a greater daytime sleepiness. This test was self-administered.|Baseline, Week 12, Endpoint (last postbaseline observation, up to Week 12)|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time point.|||units on a scale||Standard Deviation|Mean
1444956|NCT00893789|Secondary|Change From Baseline in Traumatic Brain Injury - Work Instability Scale (TBI-WIS) Total Score At Weeks 4, 8, 12 and Endpoint (Last Postbaseline Observation Up to Week 12)|The TBI-WIS is a validated participant-rated instrument for assessing a participant’s functional ability after TBI and the functional demands of their job. The assessment consists of 36 questions to which the participant responded with a “true” or “not true” answer. To score the questionnaire, the number of “true” responses is counted: if < 2, the risk is low; 2 to 23, the risk is medium; and >23, the risk is high, for work instability. Score range is 0 (lowest risk for work instability) to 36 (highest risk for work instability).|Weeks 4, 8, 12 and Endpoint (last postbaseline observation up to Week 12)|Participants in the Full Analysis Set (participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment) with a baseline TBI-WIS measurement; n=number of participants with values at given time points.|||units on a scale||Standard Deviation|Mean
1444957|NCT00893789|Secondary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Weeks 2, 4, 8, and 12|The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Weeks 2, 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with a nonmissing value at given time point.|||percentage of participants|||Number
1449221|NCT00856908|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
1444958|NCT00893789|Secondary|Change From Baseline in Mean Sleep Latency From the MSLT at Weeks 4, 8, and 12|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, Weeks 4, 8, and 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with data at given time points.|||minutes||Standard Deviation|Mean
1444959|NCT00893789|Primary|Percentage of Responders and Nonresponders According to Clinical Global Impression of Change (CGI-C) Ratings at Endpoint (Last Postbaseline Observation Up to Week 12)|The CGI-C is the clinician’s rating of disease severity as compared with pretreatment, assessed by the Clinical Global Impression of Severity (CGI-S). Severity of illness, as related to excessive sleepiness, was assessed at baseline by the CGI-S, which consists of 7 categories: normal–shows no sign of illness, borderline ill, mildly (slightly) ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The clinician assessed the change from baseline in the participant’s condition, as related to excessive sleepiness, in response to treatment. The CGI-C uses the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders were defined as those participants who were considered much or very much improved on the CGI-C. Those in all other categories of the CGI-C were considered nonresponders.|Last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment).|||percentage of participants|||Number
1444960|NCT00893789|Primary|Change From Baseline in Multiple Sleep Latency Test (MSLT) at Endpoint (Last Postbaseline Observation Up to Week 12)|The MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. Four 20-minute (maximum) MSLT naps were performed at 0900, 1100, 1300, and 1500. The participant, dressed in nonconstricting clothes, was instructed to lie quietly and attempt sleep. Each MSLT nap continued until: (a) 3 consecutive 30-second epochs of stage 1 sleep were reached or (b) any single, 30-second epoch of stage 2, 3, 4, or rapid eye movement (REM) sleep was reached. Sleep latency for each nap and average sleep latency for the 4 naps were tabulated. According to clinical protocol for the MSLT, each nap was terminated after 20 minutes if no sleep occurred. If a participant did not fall asleep in 20 minutes, his/her sleep latency for that nap was set to 20 minutes. Sleep latency was measured as the elapsed time from lights-out to the first epoch scored as sleep. With a 30-second scoring epoch, this criterion was reached when sleep occupied at least 16 seconds of any epoch.|Baseline, last postbaseline observation up to Week 12|Full Analysis Set (all participants who received 1 or more doses of study drug with ≥1 postbaseline primary efficacy assessment); n=number of participants with measurements at given time point.|||minutes||Standard Deviation|Mean
1444961|NCT00893763|Secondary|Serum Procalcitonin||5 days|||||||
1444962|NCT00893763|Secondary|Serum Cytokines||5 days|||||||
1444963|NCT00893763|Secondary|Endotracheal Tube Colonization|semiquantitative swab culture for potentially pathogenic organisms of distal end of the endotracheal tube (ETT) interior lumen at extubation. Results were collapsed into two categories: colonization (moderate or many organisms) or no colonization.|24 hours|The subjects analyzed were a subset of subjects enrolled in the study from whom endotracheal tunes were obtainable for microbial culture post-intubation. Subset analysis was planned a priori.|||percentage of ET tubes colonized|||Number
1444964|NCT00893763|Primary|Development of VAP (Clinical Pulmonary Infection Score)|Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP.|Baseline up to 5 days|Subjects who had complete CPIS data on admission to the study (Day 0) and subsequent complete CPIS data from day 2, 3, 4 or 5 (47 CHX & 47 control, 438 observations) were included in the analysis in accordance with intent to treat analysis principles.|||units on a scale||Standard Error|Mean
1444965|NCT00893737|Primary|Change in Scores From Completeness of Response Survey (CORS)|"CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.~The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication)."|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)||||Units on a scale||95% Confidence Interval|Mean
1444966|NCT00893737|Secondary|Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)|Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)||||Units on a scale||95% Confidence Interval|Mean
1444967|NCT00893737|Secondary|Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan|CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours.|Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)||||Percent of Participants|||Number
1444989|NCT00893074|Primary|Peak Effect of Marijuana Withdrawal|Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).|Day 5 of the Dronabinol abstinence period||||units on a scale||Standard Error|Mean
1444968|NCT00893464|Secondary|Overall Best Response|Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD. PD is any new lesion or increase by >50% of previously involved sites from nadir.|Baseline up to Cycle 45|Response-evaluable population included participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 postbaseline disease assessment for analyses of response.|||participants|||Number
1444969|NCT00893464|Secondary|TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib|TEmax: Time to reach the maximum observed effect (Emax), equal to time (hours) to Emax.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.|||hr||Full Range|Median
1444970|NCT00893464|Secondary|Emax: Maximum Observed Effect for Ixazomib|Emax is the maximum inhibition of 20S proteasome activity in whole blood.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The pharmacodynamic analysis population included participants who had sufficient dosing data and effect-time data to permit calculation of pharmacodynamic parameters where Days 1 and 15 assessments were available.|||percentage of inhibition||Standard Deviation|Mean
1444971|NCT00893464|Secondary|CLr: Renal Clearance|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr).|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. CLr is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.|||L/hr||Standard Deviation|Geometric Mean
1444972|NCT00893464|Secondary|Fe (0-4): Fraction of Dose Excreted Unchanged in Urine From 0 to 4 Hours Postdose|Fe (0-4) is the fraction of the dose excreted unchanged in the urine from 0 to 4 hours postdose, calculated as percentage of the exact dose administered.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population was defined as participants who had sufficient dosing data and ixazomib concentration-time data to permit the calculation of PK parameters where Days 1 and 15 assessments were available.|||percentage of dose||Standard Deviation|Geometric Mean
1444973|NCT00893464|Secondary|Ae (0-4): Amount of Drug Excreted in Urine From 0 to 4 Hours Postdose|Ae (0-4) is the total amount of drug excreted in the urine from 0 to 4 hours postdose.|Cycle 1, Days 1 and 15: 0 to 4 hours postdose|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.|||nanogram||Standard Deviation|Geometric Mean
1444974|NCT00893464|Secondary|Rac: Accumulation Ratio for Ixazomib|Rac was estimated as the ratio of AUC (0-168) on Day 15 and AUC (0-168) on Day 1. AUC (0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Rac is reported for ixazomib 1.4, 2.34 and 3.11 mg/m^2 groups only as it could not be estimated for the other dosing groups.|||ratio||Standard Deviation|Geometric Mean
1444975|NCT00893464|Secondary|Terminal Phase Elimination Half-life (T1/2) for Ixazomib|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Cycle 1 Day 15: Predose and at multiple time points (up to 336 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters.T1/2 is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.|||hr||Standard Deviation|Geometric Mean
1444976|NCT00893464|Secondary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib|AUC(0-168) is a measure of the area under the plasma concentration time-curve from time 0 to 168 hours postdose|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 168 hours postdose)|The PK analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available. AUC(0-168) is not reported for ixazomib 0.125 and 0.25 mg/m^2 as the participants were not evaluable for this parameter.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
1444977|NCT00893464|Secondary|C0: Initial Plasma Concentration After Bolus Intravenous Administration|C0 is the plasma drug concentration at time zero following bolus intravenous injection, obtained from the plasma concentration-time curve.|Cycle 1 Days 1 and 15: Predose and at multiple time points (up to 336 hours postdose)|The pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 15 assessments were available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1444978|NCT00893464|Primary|Recommended Phase 2 Dose (RP2D)|The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.|Baseline up to Treatment Cycle 45|Safety population included all participants who received at least 1 dose of ixazomib.|||mg/m^2|||Number
1444990|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||95% Confidence Interval|Number
1444979|NCT00893464|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of ixazomib that generated dose limiting toxicity (DLT) during Cycle 1 in 0 of 3 or 1 of 6 participants. DLT defined as any of the following considered possibly related to therapy by investigator: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; platelet count <25,000 cells/mm^3; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by maximal supportive therapy; Grade 3 QTc prolongation>500 millisecond (msec);any >=Grade 3 nonhematologic toxicity except arthralgia/myalgia; <1 week fatigue; delay in the initiation of the subsequent therapy cycle by >=7 days ; other Grade 2 ixazomib-related nonhematologic toxicities requiring therapy discontinuation.|Treatment Cycle 1|DLT-Evaluable Population included participants who received all Cycle 1 doses of MLN9708 and who completed Cycle 1. If Cycle 1 was interrupted by a DLT, the participant was included in this population.|||mg/m^2|||Number
1444980|NCT00893464|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, weight, systolic and diastolic blood pressure and heart rate.|Baseline and Days 1, 8, 15 of each treatment cycle up to 45 treatment cycles|Safety population included all participants who received at least 1 dose of ixazomib.|||participants|||Number
1444981|NCT00893464|Primary|Number of Participants Reporting at Least 1 TEAE Related to Laboratory Assessments|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Hematology, clinical chemistry and urinalysis were performed. TEAEs related to laboratory assessment observed at any time-points were reported under 3 system organ classes: blood and lymphatic system disorders, metabolism and nutrition disorders, and investigations.|Baseline and Days 1, 8, and 15 of each treatment cycle (up to Cycle 45)|Safety population included all participants who received at least 1 dose of ixazomib.|||participants|||Number
1444982|NCT00893464|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after last dose of study drug|Safety population included all participants who received at least 1 dose of ixazomib.|||participants|||Number
1444983|NCT00893152|Primary|Qualitative Interviews - Perspectives on Family Involvement in PTSD Treatment|"This is qualitative research. Outcomes were themes raised with regard to content to be included in a multi-family group psychoeducation program for OEF/OIF/OND veterans with PTSD and family members."|During the 1-1.5 hour interviews|Participants in focus group or individual qualitative interviews|||participants|||Number
1444984|NCT00893113|Secondary|Change in Total International Index of Erectile Function (IIEF) Score|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. A score of 0-5 is awarded to each question of the IIEF. Total IIEF scores range from 0-75. Lower scores indicate severe erectile dysfunction (0=severe erectile dysfunction), while higher scores indicate less erectile dysfunction (75=no erectile dysfunction).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.|||Change in Total IIEF Score from Baseline||Standard Deviation|Mean
1444985|NCT00893113|Secondary|Changes in American Urological Association (AUA) Symptom Index|The American Urological Association (AUA) Symptom Index is used to evaluate the severity of the patient's enlarged prostate symptoms. The AUA Symptom Index is completed by the patient. Questions are based on patient experiences in the past month and are answered on a scale of 0-5 (0 = not at all, 1 = less than one time in 5, 2 = less than half the time, 3 = about half the time, 4 = more than half the time, 5 = almost always). The scores are totaled and ranked as follows: mild (1-7), moderate (8-19), and severe (20-35).|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.|||Change in AUA Score From Baseline||Standard Deviation|Mean
1444986|NCT00893113|Primary|Change From Baseline Erectile Function Domain of the International Index of Erectile Function|The International Index of Erectile Function (IIEF) is used for the evaluation of male sexual function and diagnostic evaluation of Erectile Dysfunction (ED) severity. There are 5 domains of the IIEF: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. The Erectile Function (EF) domain of the IIEF is used to assess specific key components of ED including ability to achieve penetration and ability to maintain erection sufficient for satisfactory sexual performance. A score of 0-5 is awarded to each question of the IIEF. The EF domain pertains to questions 1, 2, 3, 4, 5, and 15. Scores are totaled and ranges are assigned to results. In the EF domain, a score of 0-30 is possible. The EF scores can be interpreted as follows: 0-6 severe dysfunction, 7-12 moderate dysfunction, 13-18 mild to moderate dysfunction, 19-24 mild dysfunction, and 25-30 no dysfunction.|Baseline and 12 Weeks|The evaluable set includes all subjects who have sufficient data to assess the primary efficacy endpoint, and who have no major protocol deviations. Subjects were analyzed according to randomized treatment. Data for 45 subjects was analyzed.|||Change in EF Domain Score from Baseline||Standard Deviation|Mean
1444987|NCT00893074|Secondary|Heart Rate|Heart rate measured after acute cannabis exposure|Assessed on Day 5 of dronabinol maintenance||||beats per minutes||Standard Error|Mean
1445038|NCT00892606|Secondary|Visual Pain Score|Patients rated their pain with the numerical VPS from 0 to 10, with 10 being the worst pain possible and 0 being no pain|48 hours||||units on a scale||Standard Deviation|Mean
1444991|NCT00892957|Primary|Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding|"Investigators were shown videos of bleeding severities to standardize assessments.~Moderate bleeding defined as:~Either >25% of the suture line bleeds, or~≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or~1 pulsatile suture line bleeding was present."|4 minutes post start of treatment application|Intent to Treat|||percentage of participants||95% Confidence Interval|Number
1444992|NCT00892957|Secondary|Laboratory Values Over Time: International Normalized Ratio(INR)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||ratio||Full Range|Median
1444993|NCT00892957|Secondary|Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||seconds||Full Range|Median
1444994|NCT00892957|Secondary|Laboratory Values Over Time: Aspartate Aminotransferase (AST)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||U/L||Full Range|Median
1444995|NCT00892957|Secondary|Laboratory Values Over Time: Alanine Aminotransferase (ALT)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||U/L||Full Range|Median
1444996|NCT00892957|Secondary|Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||mg/dL||Full Range|Median
1444997|NCT00892957|Secondary|Laboratory Values Over Time: Platelets||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||x10^3/µl||Full Range|Median
1444998|NCT00892957|Secondary|Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||x10^3/µl||Full Range|Median
1444999|NCT00892957|Secondary|Laboratory Values Over Time: Erythrocytes||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||x10^6/µl||Full Range|Median
1445000|NCT00892957|Secondary|Laboratory Values Over Time: Hematocrit||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||percentage of red blood cells in blood||Full Range|Median
1445001|NCT00892957|Secondary|Laboratory Values Over Time: Hemoglobin||Preoperative baseline through postoperative Day 14|Safety Analysis Data Set|||g/dL||Full Range|Median
1445002|NCT00892957|Secondary|Percent Change in Vital Signs: Respiratory Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set|||percent change||Full Range|Median
1445003|NCT00892957|Secondary|Vital Signs: Respiratory Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||breaths per minute||Full Range|Median
1445004|NCT00892957|Secondary|Percent Change in Vital Signs: Heart Rate|Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set|||percent change||Full Range|Median
1445005|NCT00892957|Secondary|Vital Signs: Heart Rate - Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||beats per minute||Full Range|Median
1445006|NCT00892957|Secondary|Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure|Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14|Within 14 days prior to surgery through postoperative day 14|Safety Analysis Set|||percent change||Full Range|Median
1445007|NCT00892957|Secondary|Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline||Within 14 days prior to date of surgery|Safety Analysis Set|||mm Hg||Full Range|Median
1445008|NCT00892957|Secondary|Number of Participants With Infections by Grade|"Infections were recorded according to:~Grade I: only dermis affected~Grade II: infection invades subcutaneous region but not the arterial implant~Grade III: the arterial implant is infected"|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set|||participants|||Number
1445009|NCT00892957|Secondary|Percentage of Participants With Infection at the Surgical Site||post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set|||percentage of participants||95% Confidence Interval|Number
1445010|NCT00892957|Secondary|Percentage of Participants With Graft Occlusion|Determined clinically and defined as absence of blood flow through the graft.|post-op discharge/day 1, post-op day 14 and day 30|Safety Analysis Set|||percentage of participants||95% Confidence Interval|Number
1445011|NCT00892957|Secondary|Percentage of Participants With Postoperative Rebleeding|Any rebleeding requiring surgical re-exploration|Postoperative through day 30 ± 5|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1445012|NCT00892957|Secondary|Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line|Intraoperative rebleeding at the study suture line after occurrence of hemostasis.|Intraoperative day 0|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1445013|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|10 minutes post start of treatment application|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1445014|NCT00892957|Secondary|Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|6 minutes post start of treatment application|Intent to treat|||percentage of participants||95% Confidence Interval|Number
1445015|NCT00892957|Primary|Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.|Hemostasis at the study suture line must be maintained until closure of the surgical wound.|4 minutes post start of treatment application|Intent to Treat|||Percentage of participants||95% Confidence Interval|Number
1445039|NCT00892606|Secondary|Number of Participants With Post Operative Nausea and Vomiting|rates subjects experienced PONV|48 hours||||Participants|||Count of Participants
1445040|NCT00892606|Primary|Opioid Consumption During the 48 Hours After Surgery|The amount of opioid required for postoperative pain relief|48 hours||||mg||Standard Deviation|Mean
1445016|NCT00892775|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.|From first study dose (Day 0) until study end (Week 18)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1445017|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.|Within 43 days (Days 86-128) after second vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1445018|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.|Within 43 days (Days 0-42) after first vaccination dose|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1445019|NCT00892775|Secondary|Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes|Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin’s surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin’s surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.|||Participants|||Count of Participants
1445020|NCT00892775|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.|||Participants|||Count of Participants
1445021|NCT00892775|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms|Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects,with the symptom sheet filled-in.|||Participants|||Count of Participants
1445022|NCT00892775|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/ spontaneously painful. Grade 3 redness/ swelling = redness/ swelling spreading beyond 20 millimeters (mm) of injection site.|Within 4 days after each vaccination (Days 0-3)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.|||Participants|||Count of Participants
1445023|NCT00892775|Secondary|Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses|Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.|At 42-56 days after the first and second dose of study vaccine(s).|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.|||Titres||95% Confidence Interval|Geometric Mean
1445024|NCT00892775|Secondary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42-56 days after the second dose of study vaccine (Week 18)|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.|||Participants|||Count of Participants
1445025|NCT00892775|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.|Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.|At 42-56 days after the first dose of study vaccine (Week 6)|The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.|||Participants|||Count of Participants
1445026|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number. Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters cubed||Standard Deviation|Mean
1445027|NCT00892723|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred, because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number. A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
1445028|NCT00892723|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in a scrambled order. Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately. Data from the two raters was not combined.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
1445029|NCT00892723|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Units on a scale||Standard Deviation|Mean
1445030|NCT00892710|Secondary|6-month and 12-month Overall Survival Probability|Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|12 months|Includes all enrolled patients, whether or not they received treatment|||probability out of 1||95% Confidence Interval|Number
1445031|NCT00892710|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months|Includes all enrolled patients, whether or not they were treated|||months||95% Confidence Interval|Median
1445032|NCT00892710|Secondary|Time to Treatment Failure (TTTF)|Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.|18 months|Includes all treated patients|||months||Full Range|Median
1445033|NCT00892710|Secondary|Time to Progression (TTP)|The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all treated patients|||months||95% Confidence Interval|Median
1445034|NCT00892710|Secondary|Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months|Includes all treated patients|||participants|||Number
1445035|NCT00892710|Primary|Progression Free Survival (PFS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months|Includes all enrolled patients whether they recieved treatment or not|||months||95% Confidence Interval|Median
1445036|NCT00892697|Secondary|Intrahepatic and Peripheral Pharmacokinetic Assessment of Telaprevir|Intrahepatic and plasma telaprevir concentration ratios|Day 1, Day 4, Day 15, Week 8||||telaprevir liver to plasma conc ratio||Inter-Quartile Range|Median
1445037|NCT00892697|Primary|Intrahepatic and Plasma HCV Viral Kinetics|Intrahepatic viral kinetics, plasma viral kinetics,|Day-7, Day 1, Day 4,||||log transformed copies/ml||Standard Deviation|Mean
1445041|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.|||cells/μL||Standard Deviation|Mean
1445042|NCT00892437|Secondary|Change From Baseline in CD4 Cell Count at Week 24|The change from baseline in CD4 cell count at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.|||cells/μL||Standard Deviation|Mean
1445043|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with available change data at Week 48 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
1445044|NCT00892437|Secondary|Change From Baseline in HIV-1 RNA at Week 24|The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed.|Baseline to Week 24|Participants in the ITT Analysis Set with available change data at Week 24 were analyzed.|||log_10 copies/mL||Standard Deviation|Mean
1445045|NCT00892437|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1445046|NCT00892437|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.|Week 24|ITT Analysis Set: participants who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
1445047|NCT00892281|Secondary|Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)|Number of treatment responders at week 12, where response is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (near clear). IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best and 4 being worst.|Baseline to Week 12||||participants|||Number
1445048|NCT00892281|Secondary|Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Clinician's Erythema Assessment Scale (CEA) score. Clinician's Erythema Assessment Scale (CEA) is a scale from 0 - 4 with 0 = None; 1 = Mild; 2 = Moderate; 3 = Significant; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12 in CEA.|Baaseline to Week 12||||participants|||Number
1445049|NCT00892281|Primary|Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint|Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.|Baseline to Week 12|Per protocol|||participants|||Number
1445050|NCT00892177|Secondary|Objective Response (Phase II)|Objective response to treatment will be determined by the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The percentage of patients in each response category will be summarized, 95% confidence intervals calculated, and rates between the 2 arms will be compared using a Fisher’s Exact test. For bi-dimensionally measurable disease, CR: total disappearance of all tumor and that patients be on no corticosteroids or on only adrenal replacement maintenance; PR: ≥ 50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions, and stable or decreasing steroid dosing; PD: >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions; REGR: unequivocal reduction in extent of contrast-enhancement, or a decrease in mass effect, no new lesions (for evaluable disease); SD: failure to qualify for CR, PR,REGR or PD.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.|||percentage of participants||95% Confidence Interval|Number
1445051|NCT00892177|Secondary|Patient-reported QOL, as Measure by the Functional Assessment of Cancer Therapy-Brain (FACT-Br) (Phase II)|"FACT-Br questionnaires were used to assess QOL at every other cycle of treatment (prior to cycles 3, 5, 7, etc.). FACT-Br includes 50 questions used to assess patients' self-assessment in 4 broad categories: Physical, Social/Family, Emotional, and Function Well-being. Scores range from 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very Much. Higher scores can be interpreted as having higher quality of life. The scores for all 50 questions were summed to give a total score per patient per cycle. Therefore the possible range is from 0 to 200. Below is the reported mean and standard deviation for patients at baseline and during cycles 2, 4, 6, 8, and 10."|Baseline to cycle 10 (20 weeks).|All Phase II patients that began treatment and submitted at least one FACT-Br questionnaire were included in this analysis.|||units on a scale||Standard Deviation|Mean
1445052|NCT00892177|Secondary|Time-to-disease Progression (Phase II)|Time-to-disease progression is defined as the time from start of study therapy to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death unless there is documented evidence that no progression occurred before death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. Patients who experience major treatment violations will be censored for progression on the date the treatment violation occurred. The time-to-progression distribution will be estimated using the Kaplan-Meier method.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.|||months||95% Confidence Interval|Median
1445053|NCT00892177|Secondary|Overall Survival (Phase II)|Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both arms of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.|Up to 3 years|All eligible Phase II patients are included in this Phase II endpoint analysis.|||months||95% Confidence Interval|Median
1445069|NCT00892047|Primary|Weight|Weight change in kilograms|Baseline through12 weeks|The number of participants analyzed is lower due to missing data attributable to dropouts. The information obtained is from figure 3B in the manuscript|||kilograms||Standard Deviation|Mean
1445054|NCT00892177|Secondary|Number of Participants With Adverse Events According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 (Phase II)|"Adverse events were collected systematically at the end of each cycle and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. Events are scored as: 1=Mild symptoms, 2= Moderate, 3=Severe, 4=Life-threatening, and 5=Death. The number of patients reporting a grade 3 or higher event regardless of attribution are summarized here. A complete list of all adverse events reported during treatment can be found in the Adverse Events Section."|Up to 3 years|All Phase II patients treated and evaluated for adverse events are included in this Phase II endpoint analysis.|||participants|||Number
1445055|NCT00892177|Primary|Progression-free Survival at 6 Months (PFS6) (Phase II)|The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation (PFS6). All eligible consented patients that received treatment will be considered evaluable. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS6 will be estimated as the number of evaluable patients progression free and still alive at 6 months divided by the total number of evaluable patients. The confidence interval will be calculated according to the Clopper-Pearson Method.|6 months|All patients that received treatment and were eligible for assessment were included in this analysis.|||proportion of participants||90% Confidence Interval|Number
1445056|NCT00892177|Primary|Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Bevacizumab (Phase I)|The Maximum Tolerated Dose (MTD) will be based on the assessment of dose-limiting toxicities (DLT) during the first 4 weeks of treatment only (i.e., following the first 2 treatment cycles), and will be defined as the dose at which fewer than one-third of patients experience a DLT to study treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with the next higher dose having at least 2 out of 3 or 2 out of 6 patients encountering DLT. > Three patients will be treated at each dose level, and can be enrolled simultaneously. If one DLT is encountered, an additional 3 patients will be added to that dose level. If at any point two DLTs are encountered within a given dose level, then the MTD has been exceeded and if only three patients have been treated at the next lower dose three more patients are treated at the next lower dose. The number of patients who developed DLTs are reported here by dose level, with the MTD reported in the statistical analysis section.|14 days|Adverse event information is available for 4 patients on study 1 dose level 1 (with 1 being a MTD replacement due to disease progression prior to completing cycles 1 and 2).|||participants who developed DLTs|||Number
1445057|NCT00892151|Secondary|Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3|"User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:~= Unacceptable~= Poor~= Good~= Very Good~= Excellent"|1-2 hours|Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses.|||participants|||Number
1445058|NCT00892151|Secondary|Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3|"Subjects rated ease of using the software with respect to specific tasks. The rating scale was:~= Very Simple~= Simple~= Neither Simple nor Difficult~= Difficult~= Very Difficult"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes; the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.|||percentage of participants|||Number
1445059|NCT00892151|Primary|Number of Participants Rated Successful (<=3) at Performing Specific Tasks|"Study staff rated participants on their success at perfoming specific tasks. The rating scale was:~= Successful~= Successful after being referred to user instructions~= Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~= Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)~= Problem encountered with software"|1-2 hours|Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.|||participants|||Number
1445060|NCT00892099|Secondary|Parathyroid Hormone|serum PTH levels (pg/mL)|every 4 weeks for 12 weeks|Subject receiving treatment|||pg/mL||Standard Error|Mean
1445061|NCT00892099|Secondary|Serum 1,25(OH)2 Levels|serum 1,25(OH) vitamin D levels (pg/mL)|At week 12|Subject receiving treatment|||pg/mL||Inter-Quartile Range|Median
1445062|NCT00892099|Secondary|Serum 25-OH Vitamin D|serum 25-OH vitamin D levels (ng/mL)|every 4 weeks for 12 weeks|Subject receiving treatment|||ng/mL||Standard Error|Mean
1445063|NCT00892099|Secondary|Serum Phosphate|serum phosphate levels (mmol/L)|every 4 weeks for 12 weeks|Subject receiving treatment|||mmol/L||Standard Error|Mean
1445064|NCT00892099|Secondary|Serum Calcium|serum calcium levels (mg/dL)|every 4 weeks for 12 weeks|Subject receiving treatment|||mg/dl||Standard Error|Mean
1445065|NCT00892099|Primary|Serum 25D Level||12 weeks||||ng/ml||Standard Deviation|Mean
1445066|NCT00892047|Secondary|QTc Prolongation on EKG (to Greater or Equal to 480 Msec)|percentage of participants|12 weeks|We had a smaller number of participant observations due to dropouts and missing data. This data is in Table 3 of the manuscript.|||percent of participants|||Number
1445067|NCT00892047|Secondary|Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment|percentage of participants who reported suicidal ideation during treatment but not at baseline|12 weeks|It is a smaller number of participants restricted to those who did not report any suicidal ideation at baseline. This is in Table 3of the manuscript|||percent of participants|||Number
1445068|NCT00892047|Primary|Parkinsonism|Percentage of participants who develop signs of parkinsonism|12weeks|We have a lower number of participants analyzed due to dropouts and missed assessments.|||percentage of participants|||Number
1445070|NCT00892047|Primary|Akathisia|Percentage of participants who developed clinically significant akathisia.|12 weeks||||percentage of participants|||Number
1445071|NCT00892047|Primary|Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS.|12 weeks||||percentage of participants|||Number
1445072|NCT00892008|Primary|Discontinuations Due to Adverse Events|Discontinuations due to adverse events by MedDRA system organ class and preferred term.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Safety population: all subjects who took at least one dose of study medication.|||participants|||Number
1445073|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit|Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445074|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist|Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445075|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445076|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit|Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445077|NCT00892008|Secondary|Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445078|NCT00892008|Secondary|Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits|Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.|Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445079|NCT00892008|Secondary|VAS Pain Score at Baseline and Final Visit|VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.|Baseline, Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445080|NCT00892008|Secondary|VAS Pain Score at Baseline (BL) and Second Visit|VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .|Baseline, Second Visit (Week ≥ 2)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.|||participants|||Number
1445081|NCT00892008|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.|Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)|Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N = number of subjects with a Visual Analog Scale (VAS) pain score at Baseline Visit.|||scores on scale||Standard Deviation|Mean
1445082|NCT00892008|Primary|Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)|Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.|Baseline through Final Visit (Week 4)|Safety population: all subjects who took at least 1 dose of study medication.|||participants|||Number
1445083|NCT00891995|Secondary|BMI Percentile||1 year||||percent||Inter-Quartile Range|Median
1445084|NCT00891995|Secondary|Daily Insulin Dose||1 year||||u/day/kg||Standard Deviation|Mean
1445085|NCT00891995|Secondary|CGM Measured Glucose Outcomes|Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.|1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.|||percent||Inter-Quartile Range|Median
1445086|NCT00891995|Secondary|CGM Mean Glucose||1 year|Participants who used CGM (either blinded or unblinded CGM) for at least 24 hours at 12 months.|||mg/dL||Inter-Quartile Range|Median
1445087|NCT00891995|Secondary|Adverse Events (Severe Hypoglycemia)||1 year||||participants|||Number
1445088|NCT00891995|Secondary|HbA1c||1 year||||percent||Standard Deviation|Mean
1445089|NCT00891995|Secondary|Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT|Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.|0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.|||participants|||Number
1445090|NCT00891995|Secondary|Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment||0 to 240 min post meal at 1 year MMTT|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.|||pmol/ml||95% Confidence Interval|Geometric Mean
1445091|NCT00891995|Primary|C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.|In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).|At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal|Among the 68 participants who completed 1 year visit and with positive autoantibody, 1 participant in the intensive treatment group did not complete MMTT test, thus was excluded from all C-peptide analyses.|||pmol/ml||95% Confidence Interval|Geometric Mean
1445092|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
1445093|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
1445094|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
1445095|NCT00891982|Secondary|Subject Assessment of Itching|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/Baseline||||Participants|||Number
1445096|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
1445097|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
1445098|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
1445099|NCT00891982|Secondary|Subject Assessment of Burning/Stinging|"Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||Participants|||Number
1445100|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
1445101|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
1445102|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
1445103|NCT00891982|Primary|Local Tolerability - Erythema (Redness)|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||Participants|||Number
1445104|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||Participants|||Number
1445105|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||Participants|||Number
1445106|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||Participants|||Number
1445107|NCT00891982|Primary|Local Tolerability - Skin Scaling|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||Participants|||Number
1445108|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 4||||participants|||Number
1445109|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 2||||participants|||Number
1445110|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Week 1||||participants|||Number
1445111|NCT00891982|Primary|Local Tolerability - Skin Dryness|"Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale:~0 - None~- Trace~- Mild~- Moderate~- Marked~- Severe"|Screening/baseline||||participants|||Number
1445112|NCT00891930|Secondary|Number of Subjects With Worst Post-baseline Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded using CTCAE v3.0.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2|||participants|||Number
1445113|NCT00891930|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (where 1 = Mild [aware of sign or symptom, but easily tolerated]; 2 = Moderate [discomfort enough to cause interference with usual activity]; 3 = severe [incapacitating with inability to work or do usual activity]; 4 = life-threatening; 5 = fatal), with the exception of selected skin toxicities that were graded using a modified version of CTC. Treatment-related adverse events were those events for which the investigator considered there to be a reasonable possibility that the event may have been caused by panitumumab (Part 1) and by panitumumab and/or ganitumab (Part 2). Discontinuation includes AEs leading to discontinuation of panitumumab (Part 1) and panitumumab, ganitumab (Part 2) or removal from the study.|From first dose date to 30 days since the last dose date in each part of the study. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 and Part 2|||participants|||Number
1445114|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Ganitumab|Two validated assays were used to detect the presence of anti-ganitumab antibodies. First, an eletrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding ganitumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against ganitumab.|From first dose of ganitumab until 30 days after last dose; median time frame was 2.4 months.|Primary Analysis Set - Part 2 particpants with at least 1 post-baseline immunoassay result.|||participants|||Number
1445115|NCT00891930|Secondary|Number of Participants Who Developed Antibodies to Panitumumab|Two screening immunoassays, an acid-dissociation enzyme-linked immunosorbent assay (ELISA) and a Biacore-based biosensor assay, were used to detect antibodies capable of binding to panitumumab. Postive samples were further tested for neutralizing antibodies in a cell-based epidermal growth factor receptor (EGFR) phosphorylation bioassay.|From first dose date to 30 days since the last dose date. The median time frame is 4.2 months for Part 1 and 2.4 months for Part 2.|Primary Analysis Set - Part 1 participants with at least 1 post-baseline immunoassay result.|||participants|||Number
1445116|NCT00891930|Secondary|Duration of Response|Duration of response is defined as the time from the first confirmed objective response to the earlier date of disease progression or death. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response|||months||95% Confidence Interval|Median
1445117|NCT00891930|Secondary|Time to Objective Response|Time to objective response was defined as the time from first dose of study drug to the first confirmed objective response. An objective response is defined as a confirmed complete response or partial response per modified RECIST v1.0 criteria during the treatment period.|From the first dose of study drug until the end of treatment in each Part; median duration of treatment was 16 weeks in Part 1 and 8 weeks in Part 2.|Tumor Response Evaluable Analysis Set - Part 1 and Part 2 participants with an objective response|||months||Full Range|Median
1445118|NCT00891930|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first dose of study therapy in Part 1 or Part 2 to the date of death. Participants who had not died by the analysis data cutoff date were censored at their last contact date.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1 and Part 2|||months||95% Confidence Interval|Median
1445119|NCT00891930|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the interval from the first dose of study therapy to the earlier date of disease progression (per modified RECIST version 1.0) or death prior to the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 2 where applicable. Participants who had not progressed or died during this period were censored at their last evaluable disease assessment date. Progressive Disease (PD): At least a 20% increase in the size of target or non-target lesions, significant increase in pleural effusions, ascites, or other fluid collections with cytologic proof of malignancy, or any new lesions.|From the first dose of study drug until the data cut-off date of 30 July 2013. Median time on study follow-up was 48.5 weeks for Part 1 and 32 weeks in Part 2.|Primary Analysis Set - Part 1: participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan. Part 2: participants who had radiographically confirmed disease progression on treatment in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2.|||months||95% Confidence Interval|Median
1445120|NCT00891930|Secondary|Part 1: Objective Response Rate|"Objective response rate is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified RECIST version 1.0 criteria during the treatment period.~Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From first dose of study drug until the end of treatment in Part 1; median duration of treatment was 16 weeks.|Tumor Response Evaluable Analysis Set – Part 1 (participants who had known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with at least one Baseline uni-dimensionally measurable lesion per the RECIST version 1.0 based on investigators’ review).|||percentage of participants||95% Confidence Interval|Number
1445121|NCT00891930|Primary|Part 2: Objective Response Rate (ORR)|Objective response rate (ORR) is defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in size of target lesions and no progression (increase in size) of non-target lesions and no new lesions, or, the disappearance of all target lesions, persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.|From the first dose of study drug in Part 2 until the end of treatment in Part 2; median duration of treatment in Part 2 was 8 weeks.|Tumor Response Evaluable Analysis Set - Part 2 (participants who had radiographically confirmed disease progression on panitumumab and irinotecan in Part 1 and received at least 1 dose of panitumumab and/or ganitumab in Part 2 and with at least 1 baseline uni-dimensionally measurable lesion per the RECIST v1.0 based on investigators’ review.|||percentage of participants||95% Confidence Interval|Number
1445122|NCT00891930|Primary|Part 1: Emergence of Mutant KRAS|Mutation in Kirsten rat sarcoma-2 virus oncogene (KRAS) status was determined by examining KRAS exons 2, 3, and 4. The emergence of mutant KRAS was defined as a change in KRAS mutation status from wild-type at Baseline in KRAS exons 2, 3, and 4 to mutant in any of KRAS exons 2, 3, and 4 at the time of the second biopsy following the radiographic evidence of acquired resistance to panitumumab when given in combination with irinotecan.|From first dose of study drug until the 2nd biopsy at the time of disease progression/entry into Part 2; median duration of treatment in Part 1 was 16 weeks.|KRAS analysis set (participants with known wild-type KRAS tumors from archival tumor sample and who received at least 1 dose of panitumumab and/or irinotecan in Part 1 and with known KRAS status at baseline and at acquired disease resistance to panitumumab in combination with irinotecan (i.e., based on the results of the second biopsy on study).|||percentage of participants||95% Confidence Interval|Number
1445123|NCT00891904|Secondary|Overall Survival||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter|Trial terminated early. Too few patients to analyze.||||||
1445124|NCT00891904|Secondary|Local and Distant Control||very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.|Trial terminated early. Too few patients to analyze.||||||
1445125|NCT00891904|Secondary|Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients||2 years|Trial terminated early. Too few patients to analyze.||||||
1445126|NCT00891904|Primary|Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30||Daily while on Treatment|Trial terminated early. Too few patients to analyze.||||||
1445127|NCT00891878|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.|Up to 3 years|Patients who achieved an objective response to be either a CR or PR were included in this analysis.|||months||95% Confidence Interval|Median
1445128|NCT00891878|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.|Up to 3 years|All evaluable patients|||months||95% Confidence Interval|Median
1445129|NCT00891878|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier.|Up to 3 years|All evaluable patients|||months||95% Confidence Interval|Median
1445130|NCT00891878|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Up to 3 years|All evaluable patients|||Months||95% Confidence Interval|Median
1445131|NCT00891878|Secondary|Response Rate (Complete Response or Partial Response)|A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher’s Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Up to 3 years|All evaluable patients|||percentage of patients||95% Confidence Interval|Number
1445132|NCT00891878|Primary|Comparison of Progression-free Survival|The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 3 years|All evaluable patients|||Months||95% Confidence Interval|Median
1445133|NCT00891839|Secondary|Shifts in Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status|"The ECOG scale is:~Grade 0: Fully active, able to carry on all pre-disease activities without restriction;~Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;~Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours;~Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours;~Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or Chair.~The shift table compares baseline ECOG scores to the ECOG scores as of the last treatment visit."|Day 0 (baseline) up to Month 8|Safety population. One participant dropped out prior to obtaining a post-treatment ECOG evaluation.|||participants|||Number
1445134|NCT00891839|Secondary|Shifts in Baseline to Post-Treatment in Positron Emission Tomography (PET)|Participants had a whole-body PET at baseline and at the end of cycle 6 or the end-of-treatment visit. Negative PET refers to PET results showing no abnormal lymph nodes; conversely, positive PET refers to PET results showing abnormal lymph nodes.|Baseline (Days -30 to 0), post treatment (up to Month 9, 30 days following completion of therapy)|Safety population of participants with PET data|||participants|||Number
1445135|NCT00891839|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall survival is defined as the time from first exposure to study medication to death, or to last date from adverse events, concomitant medications, vital signs, lost to follow-up, or last known alive, for overall survival censoring date.|Day 1 up to Month 57|Safety population|||months||95% Confidence Interval|Median
1445136|NCT00891839|Secondary|Kaplan-Meier Estimate for Progression-Free Survival|Progression-free survival is defined as the time from first exposure to study medication to disease progression or relapse, or death due to any cause. Progression is defined using the 2007 International Working Group criteria, as any new lesion or increase by at least 50% of previously involved sites from nadir.|Day 1 up to Month 45|Safety population|||months||95% Confidence Interval|Median
1445137|NCT00891839|Secondary|Kaplan-Meier Estimate for Duration of Response|Duration of response is defined as the time between the date of the first response to date of progression or death. Response is determined on the basis of the 2007 IWG criteria. A complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.|Day 1 up to Month 43|Safety population of participants who had a response.|||months||95% Confidence Interval|Median
1445138|NCT00891839|Primary|Overall Response Rate (Complete Response + Partial Response) at the End of Cycles 3 and 6 Using the 2007 International Working Group Criteria|"The International Working Group (IWG) criteria (Cheson et al 2007) for a complete response is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.~95% CIs are calculated using binomial exact method."|Month 3 (end of cycle 3), Month 6 (end of cycle 6)|Safety population consisting of all participants treated with at least 1 dose of bendamustine HCL.|||percentage of participants||95% Confidence Interval|Number
1445139|NCT00891813|Secondary|Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65).|The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study.|24 Weeks||||Number of participants|||Number
1445140|NCT00891813|Secondary|Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL|Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL.|24 Weeks||||Weeks||Inter-Quartile Range|Median
1445141|NCT00891813|Primary|The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL|The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients.|24 weeks|Analysis is based on the number of participants completing the study.|||Percentage of participants|||Number
1445142|NCT00891774|Secondary|Subject’s Satisfaction of the Overall Treatment||1, 3 and 6 months post injection|||||||
1445143|NCT00891774|Secondary|Investigator’s Satisfaction of the Overall Treatment||1, 3 and 6 months post injection|||||||
1445144|NCT00891774|Secondary|Reduction in Wrinkle Severity Score||Baseline, 1, 3 and 6 months post injection|||||||
1445146|NCT00891735|Secondary|Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12|The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm^2.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Disc area units||Standard Deviation|Mean
1445147|NCT00891735|Secondary|Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||mm^3||Standard Deviation|Mean
1445148|NCT00891735|Secondary|Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).|Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||µm||Standard Deviation|Mean
1445149|NCT00891735|Secondary|Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12|The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness < 270 µm.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
1445150|NCT00891735|Secondary|Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12|VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.|Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
1445151|NCT00891735|Secondary|Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Percentage of patients||95% Confidence Interval|Number
1445152|NCT00891735|Secondary|Number of Ranibizumab Injections up to But Not Including Month 12||Baseline to Month 12|All treated patients. Observed data were used with no imputation.|||Injections||Standard Deviation|Mean
1445153|NCT00891735|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12|BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.|Baseline to Month 12|Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.|||Letters||Standard Deviation|Mean
1445154|NCT00891657|Primary|Area of Sites Adherent to the Uterus (cm^2)||8-12 weeks post myomectomy||||cm^2||Standard Deviation|Mean
1445155|NCT00891657|Primary|Mean Extent Score of Sites Adherent to the Uterus|0 =no adhesions, 1=covering <25% of locations’ total area, 2=covering 26% to 50% of locations’ total area, and 3=covering >51% of locations’ total area.|8-12 weeks post myomectomy||||Scores on a Scale||Standard Deviation|Mean
1445156|NCT00891657|Primary|Mean Severity Score of Sites Adherent to the Uterus|The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.|||Scores on a Scale||Standard Deviation|Mean
1445157|NCT00891657|Primary|Number of Sites Adherent to the Uterus|The number of times an adhesion is attached to the uterus.|8-12 weeks post myomectomy|Number of subjects to have had a second laparoscopic look.|||Adhesion Sites||Standard Deviation|Mean
1445158|NCT00891618|Primary|Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)|Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Neurotoxicity Scale (FACT/GOG-Ntx) Version 4 used to assess efficacy of acupuncture for treatment-induced peripheral neuropathy among multiple myeloma and/or lymphoma patients. Severity of neuropathy measured by FACT-GOG-Ntx total score assessment where 11-item questionnaire 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT/GOG-Ntx Total Score ranges from 0 (best possible outcome) to 44 (worst possible outcome).|Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment.|Participants were excluded from primary outcome if did not complete follow up assessments.|||units on a scale||Standard Deviation|Mean
1445159|NCT00891527|Secondary|Number of Patients With Disease Stabilization at 48 Weeks||48 weeks||||Participants|||Count of Participants
1445160|NCT00891527|Secondary|Number of Patients With Disease Progression at 48 Weeks|"Patients will be classified as having disease progression if at least 2 pulmonary veins have significantly worsened at 48 weeks. This determination is based on the study defined Pulmonary Vein Status Scale, which categorizes pulmonary veins on a scale from 1- None: No narrowing of the luminal contour, to 7- Distal atretic: Complete obliteration of the luminal contour extending >5mm within the vessel segment."|48 weeks||||Participants|||Count of Participants
1445161|NCT00891527|Primary|Number of Patients With Survival at 48 Weeks||48 weeks||||Participants|||Count of Participants
1445287|NCT00890825|Secondary|Duration of Response|Duration of response is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint.|At least 12 months after start of treatment|MITT|||Days||Standard Error|Mean
1445162|NCT00891462|Secondary|Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)|Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.|||L||Standard Error|Least Squares Mean
1445163|NCT00891462|Primary|Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)|Change from Baseline to 12 weeks|Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population.|||L||Standard Error|Least Squares Mean
1445164|NCT00891436|Secondary|Histamine Content in the Tears Was Measured.|Tear samples were assayed for histamine by ELISA|Samples taken at initial visit & 2 week follow-up|All participants had tears measured for histamine.|||ng/ml||Standard Error|Mean
1445165|NCT00891436|Primary|Eosinophilic Cationic Protein (ECP) Levels|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.|Samples taken at initial visit & 2 week follow-up|Tear samples from the participants eyes were collect and were to be used for measuring esinophilic cationic prtein, but this was not measured because the volume of tears were to low.||||||
1445166|NCT00891371|Secondary|Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools||Day 56|ITT Population; Missing number of subjects: 1|||Percentage of participants|||Number
1445167|NCT00891371|Secondary|Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects|Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.|Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1|||Percentage of days per Week||Standard Deviation|Mean
1445168|NCT00891371|Secondary|Percent Change in Mean Number of Stools Compared to Baseline||Baseline (Day 1), Day 28 and Day 56|ITT Population; Missing number of subjects = 1|||Percent change||Standard Deviation|Mean
1445169|NCT00891371|Secondary|Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline|Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid|Baseline (day 1), day 28 and day 56|ITT Population; Missing number of subjects = 1|||units on a scale||Full Range|Median
1445170|NCT00891371|Secondary|Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline|"SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition~IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL"|Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56|ITT Population, Analysis based on number (n) of patients with a valid value.|||units on a scale||Standard Deviation|Mean
1445171|NCT00891371|Primary|Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)||Day 28|Intention to Treat (ITT) Population [All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods]|||Percentage of patients|||Number
1445172|NCT00891319|Secondary|Change in Upper Extremity Fugl-Meyer Score at 6-Months Post-Treatment|"The Upper Extremity Fugl-Meyer (UEFM) Assessment is a measure of upper limb motor impairment. Participants are asked to attempt to perform a list of very specific movements of the arm, elbow, forearm, wrist, and hand that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 66, minimum score of 0.~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and 6 months after completion of treatment.||||units on a scale||95% Confidence Interval|Mean
1445173|NCT00891319|Secondary|Change in Arm Motor Abilities Test Score at 6-Month Post-Treatment|"The Arm Motor Abilities Test assesses the participant’s ability to execute specific upper limb tasks and does not allow for compensation with the unimpaired side. The test consists of 9 compound tasks composed of 1 to 3 component tasks, each of which is rated on a 0 – 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it does not participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, almost normal use of affected limb; 5, normal use. The final score is the average of all component task scores across all 9 compound tasks.~The minimum score is 0; maximum score is 5. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and 6 months after completion of treatment.||||units on a scale||95% Confidence Interval|Mean
1445208|NCT00891176|Secondary|Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
1445174|NCT00891319|Primary|Change in Box and Block Test Score at 6 Mo Post-Treatment|"The Box and Blocks test counts how many times the participant can pick up 1 block at t time, move it over a partition, and release it in a target area within 60 seconds.~The minimum score is 0. There is no maximum score. The average score of healthy individuals within the age range of this study ranges from 70 to 79.~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at 6 months after completion of treatment. Then for each treatment group, these change scores were averaged."|2 timepoints: Prior to treatment, and 6 months after completion of treatment.||||blocks||95% Confidence Interval|Mean
1445175|NCT00891293|Secondary|Percent Change in Non-HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445176|NCT00891293|Secondary|Percent Change in Apo B From LOV111859/OM5 (Double-blind [DB[ Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445177|NCT00891293|Secondary|Percent Change in Apo A-1 From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study|Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445178|NCT00891293|Secondary|Percent Change in Ratio of Total-C:HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Ext. Study)|Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445179|NCT00891293|Secondary|Percent Change in HDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445180|NCT00891293|Secondary|Percent Change in LDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445181|NCT00891293|Secondary|Percent Change in VLDL-C From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study)|Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445182|NCT00891293|Secondary|Percent Change in Total Cholesterol From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB Study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension Study).|Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|MITT Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445183|NCT00891293|Primary|Percent Change in Serum Triglycerides From LOV111859/OM5 (Double-blind [DB] Study) Baseline to Week 8 of LOV111860/OM5X (1st Open-label [OL] Extension Study) and From LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL Extension).|Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.|Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24|Modified Intent-To-Treat (MITT) Population is defined as subjects who have a baseline assessment in Study LOV111859/OM5 and at least one on-therapy Study LOV111821/OM5XX efficacy assessment.|||Percentage change||Full Range|Median
1445184|NCT00891228|Secondary|The Impact on Sperm Morphology in Men Who Are Not Azoospermic||24 weeks|Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.|||percentage normal morphology||Standard Deviation|Mean
1445185|NCT00891228|Secondary|The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.||24 Weeks|Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.|||percentage of sperm||Standard Deviation|Mean
1445186|NCT00891228|Secondary|The Number of Men Who Have Azoospermia||24 Weeks||||participants|||Number
1445187|NCT00891228|Secondary|The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.||24 Weeks||||participants|||Number
1445188|NCT00891228|Primary|The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.||24 Weeks||||participants|||Number
1445189|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Platelet Counts at Week 234|Percent change in platelet count = ([platelet count at Week 234 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 platelet count assessment.|||percent change||Standard Deviation|Mean
1445190|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Liver Volume (in MN) at Week 234|Percent change in liver volume = ([liver volume at Week 234 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in MN. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 liver volume assessment.|||percent change||Standard Deviation|Mean
1445191|NCT00891202|Secondary|LTTP: Absolute Change From Baseline in Hemoglobin Level at Week 234|Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|ITT population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed=participants evaluable for this outcome measure and had available data for baseline and Week 234 hemoglobin level assessment.|||g/dL||Standard Deviation|Mean
1445192|NCT00891202|Secondary|LTTP: Percent Change From Baseline in Spleen Volume (in MN) at Week 234|Percent change in spleen volume = ([spleen volume at Week 234 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN. Baseline values for the original placebo participants refer to Day 1 of LTTP and baseline values for the original eliglustat participants refer to the Day 1 of PAP.|PAP Baseline for Eliglustat (Originally on Eliglustat) arm, LTTP Baseline for Eliglustat (Originally on Placebo) arm, Week 234|Intent-to-treat (ITT) population for LTTP included all participants who received at least 1 dose of eliglustat in LTTP period. Number of participants analyzed= participants evaluable for this outcome measure and had available data for baseline and Week 234 spleen volume assessment.|||percent change||Standard Deviation|Mean
1445193|NCT00891202|Secondary|PAP: Percent Change From Baseline in Platelet Counts at Week 39|Percent change in platelet count = ([platelet count at Week 39 minus platelet count at baseline] divided by [platelet count at baseline]) multiplied by 100.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||percent change||Standard Error|Least Squares Mean
1445194|NCT00891202|Secondary|PAP: Percent Change From Baseline in Liver Volume (in MN) at Week 39|Percent change in liver volume = ([liver volume at Week 39 minus liver volume at baseline] divided by [liver volume at baseline]) multiplied by 100, where all volumes are in MN.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||percent change||Standard Error|Least Squares Mean
1445195|NCT00891202|Secondary|PAP: Absolute Change From Baseline in Hemoglobin Level at Week 39|Absolute change = hemoglobin level at Week 39 minus hemoglobin level at baseline.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||g/dL||Standard Error|Least Squares Mean
1445196|NCT00891202|Secondary|PAP: Hemoglobin Level||PAP Baseline (Day 1)|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||gram per deciliter (g/dL)||Standard Deviation|Mean
1445265|NCT00890981|Secondary|Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA|Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445197|NCT00891202|Primary|PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo|Percent change in spleen volume = ([spleen volume at Week 39 minus spleen volume at baseline] divided by [spleen volume at baseline]) multiplied by 100, where all volumes are in MN.|PAP Baseline (Day 1), Week 39|FAS for PAP included all participants who signed informed consent and received at least one dose of study drug (placebo or eliglustat).|||percent change||Standard Error|Least Squares Mean
1445198|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age|Analysis was performed on the Total Enrolled cohort at 6 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.|||Subjects|||Number
1445199|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by ELISA. The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA).|At 3, 4 and 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||mIU/mL||95% Confidence Interval|Geometric Mean
1445200|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|"Cut-off values assessed were defined as equal to or above (≥) 6.2 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL.~Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by Enzyme-Linked Immunosorbent Assay (ELISA). The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA). Anti-HBs seroprotection was redefined as CLIA concentration above 10 mIU/mL."|At 3, 4 and 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
1445201|NCT00891176|Secondary|Anti-HBs Antibody Concentrations as Measured by ELISA|Concentrations were expressed as GMCs in mIU/mL.|At 3 and 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||mIU/mL||95% Confidence Interval|Geometric Mean
1445202|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA.|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 3 and 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age|||Subjects|||Number
1445203|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1445204|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
1445205|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
1445206|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
1445207|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age|||Titer||95% Confidence Interval|Geometric Mean
1445288|NCT00890825|Secondary|Objective Response Rate|ORR is defined as the ratio of proportions, patients with at least one visit response of CR or PR in AZD6244 + Docetaxel vs Placebo + Docetaxel.|At least 12 months after start of treatment|MITT|||Participants|||Count of Participants
1445209|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age|Analysis was performed on the Total Enrolled cohort at 4 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.|||Subjects|||Number
1445210|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||mIU/mL||95% Confidence Interval|Geometric Mean
1445211|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
1445212|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||EL.U/mL||95% Confidence Interval|Geometric Mean
1445213|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
1445214|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||μg/mL||95% Confidence Interval|Geometric Mean
1445215|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||μg/mL||95% Confidence Interval|Geometric Mean
1445216|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
1445217|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Subjects|||Number
1445218|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age|||Titers||95% Confidence Interval|Geometric Mean
1445219|NCT00891176|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.|From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age|Analysis was performed on the Total Enrolled cohort at 3 years of age, which included all subjects vaccinated in the booster study (NCT00463437) and who were part of the blood sample subset.|||subjects|||Number
1445220|NCT00891176|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed as GMCs in mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||mIU/mL||95% Confidence Interval|Geometric Mean
1445289|NCT00890825|Secondary|Progression Free Survival|PFS was defined as the interval between the date of randomisation and the earlier date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Patients who did not progress or die at the time of analysis were censored at the time of their latest evaluable objective tumour assessment. This also included patients who withdrew consent.|At least 12 months after start of treatment|MITT|||Participants|||Count of Participants
1445221|NCT00891176|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values|Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||subjects|||Number
1445222|NCT00891176|Secondary|Concentration of Antibodies Against Protein D|Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||EL.U/mL||95% Confidence Interval|Geometric Mean
1445223|NCT00891176|Secondary|Number of Subjects With Opsonophagocytic Activity|Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age|||Subjects|||Number
1445224|NCT00891176|Secondary|Antibody Concentrations Against Vaccine Pneumococcal Serotypes|"Antibody concentrations were expressed as GMCs in μg/mL.~Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
1445225|NCT00891176|Secondary|Anti-PRP Concentrations|Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||μg/mL||95% Confidence Interval|Geometric Mean
1445226|NCT00891176|Secondary|Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values|The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||subjects|||Number
1445227|NCT00891176|Secondary|rSBA-MenC Titers|Titers are given as Geometric Mean Titers (GMTs).|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||Titer||95% Confidence Interval|Geometric Mean
1445228|NCT00891176|Secondary|Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value|The cut-off value was defined as a titer equal to or above 1:128.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||subjects|||Number
1445229|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 4 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 4 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 4 years of age.|||Subjects|||Number
1445230|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 6 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 6 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 6 years of age.|||Subjects|||Number
1445231|NCT00891176|Primary|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value|rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.|At 3 years of age|Analysis was performed on the According-to-Protocol cohort for antibody persistence at 3 years of age, which included all evaluable subjects who had received the full vaccination course in the primary study (NCT00334334) and in the booster study (NCT00463437) and had available results at 3 years of age.|||subjects|||Number
1445232|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameter for BMI to Last Assessment of Study|Growth velocity parameter BMI percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.|||Percentile||Full Range|Median
1445233|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameters to Last Assessment of Study|Growth velocity parameter weight percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.|||Percentile||Full Range|Median
1445234|NCT00891046|Secondary|Percentage of Participants With Inactive Disease|Inactive disease was defined as no joints with active arthritis; no fever (body temperature ≤ 38 degree Celsius); no rheumatoid rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to SJIA; normal CRP, and a rating of no disease activity on the Physician’s Global Assessment of disease activity (with a best possible score ≤10 mm on the VAS).|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.|||Percentage of participants|||Number
1445235|NCT00891046|Secondary|Change From Baseline in Growth Velocity Parameter for Height to Last Assessment of Study|Growth velocity parameter height percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, 'Number of participants analyzed' signifies those participants with a value at both baseline and the respective post baseline time point.|||Percentile||Full Range|Median
1445236|NCT00891046|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Score to Last Assessment of Study|Sleep patterns in children and adolescents aged between 11 and 15 years were determined using PDSS instrument to evaluate whether canakinumab helps in reducing sleepiness in children with SJIA. Participants were assessed on 8 items of PDSS, on a scale of 0 to 4 (0 - never, 1 - seldom, 2- sometimes, 3 - frequently and 4 - always). The sum of all the items was reported as total score with a range of 0-32. Change from baseline was calculated by using the formula = (post baseline value - baseline value). A positive change from baseline score indicated improvement.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here, ‘Number of participants analysed’ signifies those participants with a value at both baseline and the respective post baseline time point and with an assessment of PDSS score in the given visit..|||units on a scale||Full Range|Median
1445237|NCT00891046|Secondary|Change From Baseline in EuroQual 5 ­Dimension Health Status Questionnaire (EQ­5D) Utility Index and Health State Assessment Scores [EQ Visual Analog Scale (EQ-VAS)] to Last Assessment of Study|EQ­5D HRQoL tool was employed for participants above 12 years and EQ­5D proxy for 8 – 11 years. Utility based EQ­5D questionnaire was in two parts and provides generic measure of health for clinical and economic appraisal based on 2 parts: EQ-5D descriptive system and EQ-VAS. EQ-5D descriptive system contains 5 dimensions each with 3 levels (Level 1: no problem, Level 2: moderate problem, Level 3: severe problem): mobility (1=0, 2=0.069, 3=0.314), self care (1=0, 2=0.104, 3=0.214), usual activities (1=0, 2=0.036, 3=0.094), pain/discomfort (1=0, 2=0, 3=0.386) and anxiety/depression (1=0, 2=0.071, 3=0.2). EQ-5D Total score= 1 - 0.081 - (score of level 2 in present) - 0.269 (if at least one of level 3 presents). EQ-5D total score: 1 = high quality of life; -0.59 worst quality of life. EQ-VAS recorded participant's self-rated health on vertical, visual analog scale- '100': Best and ‘0': Worst imaginable health state. A positive change from baseline score indicated improved health status.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with EQ­5D assessment in the given visit.|||units on a scale||Full Range|Median
1445238|NCT00891046|Secondary|Change From Baseline in Health­Related Quality of Life (HRQoL) Over Time Based on Child Health Questionnaire­ Parent Form (CHQ­PF50) to Last Assessment of Study|The Child Health Questionnaire – Parent Form (CHQ­PF50) instrument was used to measure HRQoL aged 5 to 18 years from a parent’s perspective. This 14 concept questionnaire measured physical and psychosocial health of the participants on following points: physical functioning, role/social emotional, role/social behavior, role/social physical, bodily pain, general behavior, mental health, self-esteem, general health perception, change in health, parental impact ­ emotional, parental impact – time, family activities, and family cohesion. Total score ranged from 1-100. Increase in score represented improvement in overall well being of participants. Change from baseline was calculated by using the formula = (post baseline value – baseline value).|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population. Here 'Number of participants analysed' signifies number of participants with HRQoL assessment in the given visit.|||units on a scale||Full Range|Median
1445239|NCT00891046|Secondary|Change From Baseline in Disability, Overall Well­Being and Pain Intensity Scores Based on Child Health Assessment Questionnaire (CHAQ) to Last Assessment of Study|The CHAQ was used to assess physical ability, overall well- being and pain intensity experienced by participants. The CHAQ (disability and well-being) dimension consisted of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Participants were graded for the response in four categories, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Participant’s pain intensity was assessed by parents and adult participants (18­20 years old) on a VAS scale of 0-100 mm (0 mm: no pain to 100: very severe pain). Change from baseline was calculated by using the formula = (post baseline value – baseline value). For both scales, lower scores indicate increased functional ability.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was performed in FAS population.|||units on a scale||Full Range|Median
1445266|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445240|NCT00891046|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as at least 6 months of inactive disease or at least 12 months of inactive disease on medication during the extension period. Participants with inactive disease for at least 6 months, but had loss of inactive disease before 12 months were also determined.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an assessment in the given visit.|||Percentage of participants|||Number
1445241|NCT00891046|Secondary|Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg|The canakinumab dose could be reduced from 4 mg/kg to 2 mg/kg in participants who were steroid-free, if requested by the treating physician and agreed by the sponsor. For treatment naive participants , dose reduction was allowed after the participant had received 6 months treatment with canakinumab.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population.|||participants|||Number
1445242|NCT00891046|Secondary|Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen|Steroid tapering with oral steroids was allowed if the participant achieved an adapted ACR Paediatric 50 response and had no fever. A participant was considered to have tapered steroids successfully, if the steroid dose was reduced from baseline and the participant did not flare and maintained a minimum adapted ACR Paediatric 30 at the last measurement. A participant was considered to have unsuccessfully tapered steroids if the steroid dose was reduced during the study but dose at last assessment was equal to or greater than dose at baseline or; if steroid dose was reduced but the participant did not maintain a minimum adapted ACR Paediatric 30 at the last measurement.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants who were steroid users at baseline.|||Percentage of participants|||Number
1445243|NCT00891046|Secondary|Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever in the preceding week (variable 7) and with no more than one variable 1 to 6 worsening by more than 30%. For minimum adapted ACR paediatric scores, the last measurement recorded from the participant's previous study was considered baseline for the current study.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit.|||Percentage of participants|||Number
1445244|NCT00891046|Secondary|Percentage of Non-­Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician’s Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of ­CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analysed' signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treated: Group 2 (Completed core study)' there were no Non-Responders participants available.|||Percentage of participants|||Number
1445245|NCT00891046|Primary|Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0­100 mm VAS; 2. Participants Global Assessment on a 0­100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit. For arm 'ACZ885 treatment naive: Group 2' there were no participants who had discontinued other biologics due to safety/tolerability issues.|||Percentage of participants|||Number
1445246|NCT00891046|Primary|Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0­100 mm VAS; 2. Participants Global Assessment on a 0­100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.|||Percentage of participants|||Number
1445290|NCT00890825|Primary|Overall Survival|OS was calculated as the interval from the date of randomisation to the date of patient death (any cause). Patients who had not died at the time of the final analysis, or who withdrew consent, were censored at the last date the patient was known to be alive.|At least 12 months since start of treatment.|MITT|||Participants|||Count of Participants
1445247|NCT00891046|Primary|Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study|Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 1-100 millimeter (mm) visual analog scale (VAS); 2. Participants Global Assessment on a 1-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of C-reactive protein (CRP) and 7. Absence of intermittent fever due to severe juvenile idiopathic arthritis (SJIA) during the preceding week. Response was defined as more than or equal to (≥) 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature less than or equal to (≤) 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.|Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier|The analysis was done in FAS population. Here 'Number of participants analyzed’ signifies number of participants with an ACR assessment at the given visit.|||Percentage of participants|||Number
1445248|NCT00891046|Primary|Number of Participants With Clinically Significant Local Injection Site Reactions During the Study|Local injection site tolerability was assessed on the injection site. Each participant was classified into one of the following four categories: 1. no tolerability reactions at any time during the study, 2. mild reaction observed on at least one occasion but no moderate or severe reactions. 3. moderate reaction observed on at least one occasion but no severe reaction. 4. severe reaction observed on at least one occasion.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed in SS population.|||participants|||Number
1445249|NCT00891046|Primary|Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study|Immunogenicity assessment included determination of anti­canakinumab (ACZ885) antibodies in serum samples using BIAcore system.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed on the SS population.|||participants|||Number
1445250|NCT00891046|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participants or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator.|From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)|The analysis was performed in safety set (SS), defined as all participants who received at least one dose of study drug.|||participants|||Number
1445251|NCT00891020|Secondary|Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24|The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Score on a scale||Standard Deviation|Mean
1445252|NCT00891020|Secondary|Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24|The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.|Baseline, Weeks 8,16,24|"Intent-to-treat population includes all participants who received at least 1 dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Score on a scale||Standard Deviation|Mean
1445253|NCT00891020|Secondary|Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20|Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient’s benefit-risk after Week 12.|Weeks 12,16, 20|"Safety population includes participants who received at least one dose of study drug. n in each of the categories is the number of participants previously on 4mg/kg + DMARD and receiving a dose at the current visit. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period."|||Participants|||Number
1445254|NCT00891020|Secondary|Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8|Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.|Baseline, Week 8|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
1445267|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445291|NCT00890721|Secondary|Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days||30 days|||||||
1445255|NCT00891020|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24|"The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:~Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and~At least 3 of the following 5 assessments:~Patient’s global assessment of pain-Visual Analog Scale (VAS)~Patient global assessment of disease activity-(VAS)~Physician global assessment of disease activity-(VAS)~Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)~Acute phase response C-Reactive Protein (CRP)"|Baseline, Weeks 8,16,24|Intent-to-treat population includes all participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received.|||Percentage of Participants|||Number
1445256|NCT00891020|Secondary|Change From Baseline in DAS28 Score at Weeks 8, 16 and 24|"The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of > 5.1 represents high disease activity.~The Change from Baseline to Weeks 8, 16 and 24 is reported."|Baseline, Weeks 8,16,24|"Intent-to-treat includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Score on a scale||Standard Deviation|Mean
1445257|NCT00891020|Secondary|Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24|Clinical Remission is defined as a Disease Activity Score 28 [DAS28] < 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Weeks 8,16,24|"Intent-to-treat population includes participants who received at least one dose of study drug. Patients were included in the treatment group to which they were randomized or assigned, regardless of the treatment actually received. n in each of the categories is the number of participants with data available for analysis at the given time point."|||Percentage of Participants|||Number
1445258|NCT00891020|Secondary|Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest|"Non-serious adverse Events of Special interest include:~Serious/Medically Significant Hepatic Events~Spontaneous /Serious Bleeding~Malignant Neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
1445259|NCT00891020|Secondary|Percentage of Participants Experiencing Serious Adverse Events of Special Interest|"Serious Adverse Events of Special interest include:~Serious infections including opportunistic infections~Complications of diverticulitis (including lower gastrointestinal [GI] perforations)~Myocardial infarction/acute coronary syndrome~Stroke~Spontaneous or serious bleeding~Malignant neoplasms"|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
1445260|NCT00891020|Primary|Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period|"An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:~Was fatal (results in death)~Was life-threatening~Required in-patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was medically significant or required intervention to prevent one or other of the outcomes listed above."|24 Weeks|Safety Population. Patients were included in the TCZ dose group according to the first infusion they actually received. Patients were assigned as using a nonbiologic DMARD if they took at least 1 dose of nonbiologic DMARD during the treatment period. Patients who did not take at least 1 dose of nonbiologic DMARD were considered as on monotherapy.|||Percentage of Participants|||Number
1445261|NCT00890981|Secondary|Actual Value of Procollagen Type 1 N-terminal Peptide|Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.|||µg/L||95% Confidence Interval|Least Squares Mean
1445262|NCT00890981|Secondary|Actual Value of Serum Type I C-telopeptide|Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179).|Day 1|Participants with observed data.|||ng/mL||95% Confidence Interval|Least Squares Mean
1445263|NCT00890981|Secondary|Percent Change of Total Radius BMD From the Parent Study Baseline by DXA|Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445264|NCT00890981|Secondary|Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA|Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445286|NCT00890825|Secondary|Change From Baseline in Tumour Size at 6 Week.|Percentage change from baseline in tumour size at 6 week. Values calculated as tumour sizes at 6 weeks minus value at baseline.|6 weeks after first dose of treatment|MITT|||Percentage change from baseline||80% Confidence Interval|Least Squares Mean
1445268|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445269|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445270|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445271|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445272|NCT00890981|Secondary|Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445273|NCT00890981|Primary|Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT|Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.|Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.|Participants with observed data.|||Percent change||95% Confidence Interval|Least Squares Mean
1445274|NCT00890929|Secondary|OS of Responders|OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)||||weeks||Full Range|Median
1445275|NCT00890929|Secondary|Time to PR|Responses were assessed according to the ELN guidelines.|36 weeks||||weeks||Full Range|Median
1445276|NCT00890929|Secondary|Time to CR|CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.|18 weeks||||weeks||Full Range|Median
1445277|NCT00890929|Secondary|Overall Survival (OS)|OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.|88 weeks (median)||||weeks||Full Range|Median
1445278|NCT00890929|Secondary|Overall Response Rate (ORR)|ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.|26 months||||percentage of subjects|||Number
1445279|NCT00890929|Secondary|Remission Duration|Responses and remission were assessed according to the ELN guidelines.|26 months||||weeks||Full Range|Median
1445280|NCT00890929|Secondary|Maximum Tolerated Dose (MTD) of Lenalidomide|The maximum tolerated dose (MTD) of lenalidomide was determined in study phase 1, for use in study Phase 2 (not conducted). The outcome is reported as the dose of lenalidomide that represents the MTD.|15 months|This outcome only includes results from participants in study Phase 1.|||mg/day lenalidomide (oral)|||Number
1445281|NCT00890929|Secondary|4-week Survival Rate|"Early death was assessed as death within 28 days of the start of treatment"|28 days||||percentage of subjects remaining alive|||Number
1445282|NCT00890929|Primary|Compete Remission (CR) Rate|Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood.|12 months||||percentage of subjects|||Number
1445283|NCT00890916|Primary|Grasp Release Test - Test of Functional Ability to Pick up and Move Objects|Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) [Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers [Peckham, 2001]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.|6-9 weeks||||Number of Completions||Full Range|Median
1445284|NCT00890825|Secondary|Alive and Progression-Free at 6 Months|Percentage of patients alive and progression-free at 6 months|6 months after first dose of treatment|MITT|||percentage|||Number
1445285|NCT00890825|Secondary|Change From Baseline in Tumour Size at Week 12|Percentage change from baseline in tumour size at Week 12. Values calculated as tumour sizes at 12 weeks minus value at baseline.|12 weeks|MITT|||Percent change from baseline||80% Confidence Interval|Least Squares Mean
1445292|NCT00890721|Primary|The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo.|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain and respond to the following question: “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?”|72 hours||||units on a scale*hr||Standard Error|Least Squares Mean
1445293|NCT00890695|Secondary|Hospital Admission or Death||from enrolment to 3 months|All participants recruited until trial halted|||participants|||Number
1445294|NCT00890695|Secondary|Anemia (Hb <9.3g/dl)||at 4 weeks|All participants recruited until trial halted|||participants|||Number
1445295|NCT00890695|Secondary|Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)||at 4 weeks and 3 months|All participants recruited until trial halted|||participants|||Number
1445296|NCT00890695|Secondary|MUAC for Age Z Score at 3 Months||between enrolment and 4 weeks and at 3 months|All participants recruited until trial halted|||Z score||95% Confidence Interval|Mean
1445297|NCT00890695|Secondary|WHZ Score at 3 Months||between enrolment and 3 months|All participants recruited until trial halted|||Z scores||95% Confidence Interval|Mean
1445298|NCT00890695|Primary|Weight for Height z Score at 4 Weeks|"The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition.~A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ<-2 and <-3 respectively. These correspond to 2 and 3 standard deviations below the reference median.~Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines."|between enrolment and 4 weeks|All participants recruited until trial was halted|||units on a scale||95% Confidence Interval|Mean
1445299|NCT00890682|Secondary|Adverse Event Profile|Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days|30 days|||||||
1445300|NCT00890682|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|"The AUC of the NRS-R pain intensity scores from time 0 through 24 hours~The subject was to rest for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?”"|0-24 hours||||Units on a scale*hours||Standard Error|Geometric Mean
1445301|NCT00890656|Primary|Number of Participants With Complete Remission|Complete remission (CR) required a marrow with ≤ 5% blasts in a normo- or hypercellular marrow with an absolute neutrophil count (ANC) of ≥ 1 * 10^9/L and a platelet count of ≥ 100 * 10^9/L with complete resolution of all sites of extramedullary disease required.|Response evaluated following first course at 14 -21 days and 1-2 weeks later to confirm response status (or at the time of hematologic recovery) and with visits every 2-3 courses.||||Participants|||Number
1445302|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)|Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.|4 - 9 weeks|32 subjects started the third and final titration regimen and 12 met their blood pressure goals. 20 dropped out for lack of efficacy.|||Participants|||Number
1445303|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.|4 to 9 weeks|73 patients started the second titration regimen and 41 met their blood pressure goal. There were no dropouts. 32 started the final titration regimen.|||Participants|||Number
1445304|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)|Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks|4 to 9 weeks on combination therapy|In this first titration group 106 patients started and 33 achieved their blood pressure goal. There were no dropouts and 73 subject started the second titration regimen.|||Participants|||Number
1445305|NCT00890591|Primary|Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)|Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level|4 - 9 wks of olmesartan monotherapy|In this first dosage group 144 started and 38 patients met their blood pressure goal; therefore, 106 started the first titration regimen. There were no dropouts.|||Participants|||Number
1445306|NCT00890552|Secondary|Duration of Response|Assessed as the median value for the time from first partial response until progression; death; or last follow-up.|32 months|All participants who achieved at least a partial response (9 subjects were not included due to not having any response)|||months||Full Range|Median
1445307|NCT00890552|Secondary|Event-free Survival (EFS)|Assessed as the median value for EFS 12 months after starting MDR treatment|12 months|All participants starting MDR treatment|||months||Full Range|Median
1445308|NCT00890552|Secondary|Overall Survival (OS)|Participants alive 12 months after starting MDR treatment.|12 months|All subjects receiving MDR treatment.|||percentage of participants|||Number
1445341|NCT00889863|Secondary|Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic||28 Weeks|Participants from the Full Analysis set who were taking oral steroids at the start of the study.|||Percentage of participants||95% Confidence Interval|Number
1445309|NCT00890552|Primary|Hematologic Response Rate|At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%).|8 weeks|Subjects completing at least one full cycle of study treatment|||participants|||Number
1445310|NCT00890409|Secondary|Major Adverse Events|Major adverse events were defined as severe arrhythmia (II or III degree A-V block or atrial or ventricular arrhythmia), major venous thrombosis, refractory hypotension (mean blood pressure less than 40 mmHg), moderate or severe scleredema (greater or equal to 20% body surface area), and severe bleeding.|18 months||||participants|||Number
1445311|NCT00890409|Primary|Severe Neurodevelopmental Disability|Severe disability was defined as cerebral palsy (CP) or mental retardation (MR). The definition of MR was development quotient (DQ) <70 by Gesell’s Child Development Scale and CP was based on the Criteria of a level 3 to 5 by the Gross Motor Function Classification System (GMFCS).|18 months||||participants|||Number
1445312|NCT00890409|Primary|Death|The number of deaths by 18 months of age.|18 months||||participants|||Number
1445313|NCT00890201|Secondary|Normal Preoperative Serum Values of Amylase and Lipase||24 hours|||||||
1445314|NCT00890201|Secondary|Normal Operative Cholangiography||24 hours|||||||
1445315|NCT00890201|Secondary|Amylase and Lipase Values in Gallbladders With Cholelithiasis||24 hours|||||||
1445316|NCT00890201|Secondary|Amylase and Lipase Values in Normal Gallbladders||24 hours|||||||
1445317|NCT00890201|Primary|Amylase and Lipase Values in Gallbladder Bile|Normal values of lipase and amylase in gallbladder bile should be zero|24 hours|The number of participants analyzed was determined by the number of participants that matched the inclusion criteria. As posted elsewhere some participants were excluded from this analysis based in the exclusion criteria of the protocol.|||mg/dl||Standard Deviation|Mean
1445318|NCT00890097|Primary|Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging|The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.|Baseline, up to Month 30|This analysis population included all treated subjects. A subject was considered treated if they had a first or last dosing date in the database.|||square millimeters per year||95% Confidence Interval|Mean
1445319|NCT00890084|Secondary|Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007|Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients|12 weeks|all investigators participating in the trial|||percentage of prescribers||95% Confidence Interval|Number
1445320|NCT00890084|Secondary|Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg||12 weeks|Intention to treat (ITT)|||percentage of patients||95% Confidence Interval|Number
1445321|NCT00890084|Secondary|Change in Concomitant Antihypertensive Drugs Given at Study Entry|Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.|baseline and 12 weeks|Intention to treat (ITT)|||percentage of patients||95% Confidence Interval|Number
1445322|NCT00890084|Secondary|Treatment Patterns|Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).|12 weeks|ITT Population|||Percentage of patients|||Number
1445323|NCT00890084|Secondary|BP Response Rate (Drop of Systolic BP of 10mmHg or More)|BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)|12 weeks|ITT Population|||Percentage of patients||95% Confidence Interval|Number
1445324|NCT00890084|Secondary|Absolute Blood Pressure Decrease|systolic blood pressure|baseline and 12 weeks|Intention to treat (ITT)|||mm Hg||95% Confidence Interval|Mean
1445325|NCT00890084|Secondary|Percentage of Patients With Blood Pressure < 130/80 mm Hg||12 weeks|Intention to Treat (ITT)|||Percentage of participants||95% Confidence Interval|Number
1445326|NCT00890084|Primary|Percentage of Patients With Blood Pressure < 140/90 mm Hg|% of high risk patients with Blood Pressure < 140/90 mm Hg|12 weeks|Intention-to-Treat (ITT)|||Percentage of participants||95% Confidence Interval|Number
1445327|NCT00889928|Primary|Procedure Completion|Completion of procedure - transvaginal removal of the gallbladder|Day of Surgery|All subjects on whom the procedure was attempted.|||participants|||Number
1445328|NCT00889915|Secondary|Clinical Global Improvements-Acceptability (CGI-A) Scale|The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability|Measured at each participant's last visit, which can occur at or before Week 6||||Units on a scale||Full Range|Median
1445329|NCT00889915|Secondary|Clinical Global Impressions-Improvement (CGI-I) Scale|The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse.|Measured at each participant's last visit, which can occur at or before Week 6||||Units on a scale||Full Range|Median
1445373|NCT00889603|Other Pre-specified|Number of Participants Receiving Other Medications|Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.|Baseline and Week 24|Safety population|||Participants|||Number
1445330|NCT00889915|Primary|Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale|The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.|Measured at each participant's last visit, which can occur at or before Week 6||||Units on a scale||Full Range|Median
1445331|NCT00889863|Secondary|Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact–emotional, Parental impact–time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates.|Start Part II (Week 32), End Part II (total duration - 88 Weeks)|Full Analysis Set Part II-patients aged 5-18 years.|||Score on a scale||Standard Error|Least Squares Mean
1445332|NCT00889863|Secondary|Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)|The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: Physical functioning, Role/social emotional, Role/social behavior, Role/social physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact – emotional, Parental impact – time, Family activities, and Family cohesion. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement.|Baseline, End of Part I ( Week 32)|Participants from the Full Analysis Set Part I-age 5 to 18 years.|||Score on a scale||Full Range|Median
1445333|NCT00889863|Secondary|Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI)|"CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do).~Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates."|Start of Part II (Week 32), End of Part II ( total duration-88 weeks)|Full Analysis set Part II.|||Score on a scale||Standard Error|Least Squares Mean
1445334|NCT00889863|Secondary|Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I|The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other “activities”. Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement.|Baseline, End of Part I (Week 32)|Participants from the Full Analysis Set Part I with data at baseline and End of Part I.|||Score on a scale||Full Range|Median
1445335|NCT00889863|Secondary|Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response|"Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response.~ACR response is determined by the following items:~Physician’s global assessment of disease activity~CHAQ-patient’s overall wellbeing~CHAQ-Functional ability~Number of joints with active arthritis~Number of joints with limitation of motion~C-Reactive Protein.~No intermittent fever in the preceding week"|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set Part II|||Days||95% Confidence Interval|Median
1445336|NCT00889863|Secondary|Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a||Day 3|Participants from the Full Analysis Set Part I with temperature readings at Day 3.|||Percentage of participants||95% Confidence Interval|Number
1445337|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 70 and a Normal CRP.|||Days||Standard Deviation|Mean
1445338|NCT00889863|Secondary|Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein|Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein|Baseline, Week 32|Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP.|||Days||Standard Deviation|Mean
1445339|NCT00889863|Secondary|Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I|"Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following:~improvement from baseline of ≥ 30%, ≥ 50%, ≥ 70%, ≥ 90%, or 100%, in at least 3 of the first 6 response variables~Physician’s global assessment of disease activity~CHAQ-patient’s overall well-being~CHAQ-Functional ability~# of joints with active arthritis~# of joints with limitation of motion~C-Reactive Protein.~no intermittent fever in the preceding week~no more than one of the first 6 response variables worsening by more than 30%"|Baseline, 32 Weeks|Participants from the full analysis set with an assessment at the given time-point.|||Percentage of participants|||Number
1445340|NCT00889863|Secondary|Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c||Start of Part Ic (After Week 8) to End of Part Ic (Week 28)|Participants from the Full Analysis set who were taking oral steroids at the start of Part Ic.|||Percentage of participants||90% Confidence Interval|Number
1445342|NCT00889863|Primary|Part II: Survival Estimate of Time to Flare|"Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following.~Reappearance of fever (>38°C, lasting for at least 2 consecutive days) not due to infections~Flare according to the JIA pediatric criteria for flare (all criteria must have been met):~≥ 30% worsening in at least 3 of the first 6 response variables~≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II."|Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)|Full Analysis Set in Part II|||Days||95% Confidence Interval|Median
1445343|NCT00889863|Primary|Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid|Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures.|32 Weeks|Participants from the Full Analysis Set who were taking oral steroids at the beginning of Part I.|||Percentage of participants||90% Confidence Interval|Number
1445344|NCT00889824|Primary|Change in Dynamic Gait Index (DGI) From Baseline to 6 Weeks.|The DGI is designed to measure a patient's functional balance and postural stability on a scale of 0-3 (3 being normal) for each task. A series of 8 tasks including walking on a level surface, walking while changing speeds, walking with head turns, walking then turning, stepping over obstacles, walking around obstacles, and stairs. For a total scale of 0-24.|6 weeks|The Dynamic Gait Index (DGI) data were analyzed by way of an linear mixed (LM) model. The DGI response data were treated as the dependent observations.|||units on a scale||Standard Deviation|Mean
1445345|NCT00889720|Secondary|Number of Treatment Emergent Adverse Events by Severity|Mild: did not interfere with usual function; Moderate: interfered to some extent with usual function; Severe: interfered significantly with usual function. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence was taken. Missing baseline severities were imputed as mild.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.|||events|||Number
1445346|NCT00889720|Secondary|Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline|Treatment-emergent AE (TEAE): any untoward medical occurrence that occurred or worsened after beginning study treatment without regard to causal relationship. Treatment-related TEAE: investigator assessment of reasonable possibility that treatment caused or contributed to AE. Severe TEAE: interfered significantly with usual function. SAE: AE resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience (immediate risk of death), persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason.|Baseline through Week 26 (within 30 days of last dose)|Safety analysis set: participants who took at least 1 dose (including partial doses) of study medication. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.|||participants|||Number
1445347|NCT00889720|Secondary|Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline.||Baseline, Week 12, Week 26|Surgical population: Not analyzed due the limited number of participants recruited.|||percentage of participants|||Number
1445348|NCT00889720|Secondary|Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|Week 26|Surgical population: N = number of participants who had a Week 26 visit.|||participants|||Number
1445349|NCT00889720|Secondary|Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|Week 12|Surgical population: N = number of participants who had a Week 12 visit.|||participants|||Number
1445350|NCT00889720|Secondary|Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline.||Baseline, Week 8|Surgical population. Not analyzed due the limited number of participants recruited.|||percentage of participants|||Number
1445351|NCT00889720|Secondary|Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System|Grade 0: no post-operative (post-op) complications (comp), Grade 1: any deviation from normal post-op course without need for pharmacological treatment (PT) other than allowed interventions (INT), or surgical, endoscopic or radiological INT; Grade II: required PT with drugs other than those allowed for grade I comp; Grade III required surgical, endoscopic or radiological INT, IIIa: not under general anaesthesia (GA), IIIb: under GA; Grade IV: life-threatening comp requiring IC/ICU management, IVa: single organ dysfunction (DSF), IVb: multiorgan DSF; Grade V: death. Not done = not assessed.|Baseline through Week 26|Surgical Population; N = participants who took at least 1 dose of study medication and received planned surgery. Results provided for participants who had a study visit at timepoint. For participants with more than 1 incidence of surgical complication recorded, the most severe incidence was used for analysis. Abbreviations: PS=post-surgery.|||participants|||Number
1445374|NCT00889603|Other Pre-specified|Number of Participants With Treatment Tolerability|Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor|Week 24|Safety population; N=number of particpants with evaluable data.|||Participants|||Number
1445395|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 4 (Day 14) pre-dose, pre-allergen challenge||||eyes|Participants||Number
1445352|NCT00889720|Primary|Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.|Responder defined as participant who answered “No” to question on Nicotine Use Inventory (NUI), “Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?” Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration <10 parts per million (ppm).|7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)|Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery.|||participants|||Number
1445353|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 26|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 26|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit.|||participants|||Number
1445354|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria at Week 12|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Week 12|Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit.|||participants|||Number
1445355|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit.|||participants|||Number
1445356|NCT00889720|Primary|Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3|Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (>40). Surgical site complication defined as total score >10; wound infection defined as total score >20. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit.|||participants|||Number
1445357|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.|||participants|||Number
1445358|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.|||participants|||Number
1445359|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.|||participants|||Number
1445360|NCT00889720|Primary|Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale|Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm, c: large volume, D: prolonged > 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd > 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.|||participants|||Number
1445361|NCT00889720|Primary|Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection|Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.|Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26|Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken.|||participants|||Number
1445362|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 26|Surgical Population; N= number of participants with a Week 26 visit.|||participants|||Number
1445363|NCT00889720|Primary|Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Week 12|Surgical Population; N= number of participants with a Week 12 visit.|||participants|||Number
1445364|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 6-10|Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.|||participants|||Number
1445365|NCT00889720|Primary|Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition|Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.|Post-surgery Days 1-3|Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.|||participants|||Number
1445366|NCT00889720|Primary|Percentage of Fully Compliant Participants|Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery.|Baseline through Week 12|Surgical Population: subset of Full Analysis Set; includes all participants who took at least 1 dose (including partial doses) of study medication and received their planned surgery within the study period. N = participants in surgical population.|||percentage of participants|||Number
1445367|NCT00889707|Secondary|Change in Maximum Urinary Flow Rate (Qmax) From Baseline to 3 Months (Qmax at 3 Months Minus Qmax at Baseline)|A printout of uroflowmetry was provided to a central, blinded, independent reviewer for determination of the Qmax values to be used for evaluation of efficacy. The central, independent, blinded reviewer determined the Qmax from over-reads of the uroflowmetry printouts, applying the 2-second rule to reduce variability and increase the accuracy.|3 months after treatment|The protocol-defined efficacy evaluable (EE) primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel|||ml/sec||Standard Deviation|Mean
1445368|NCT00889707|Primary|Change in International Prostate Symptom Scale (IPSS) of Lower Urinary Tract Symptoms From Baseline to 3 Months (Total Score at 3 Months Minus Total Score at Baseline)|Total of 7 questions regarding lower urinary tract symptoms, with each question scored on a range of 0 (not at all) to 5 (almost always have the symptom). The total score is the summation of all 7 questions, and therefore has a possible range of 0 to 35.|3 months post-treatment|The efficacy evaluable (EE) protocol defined primary analysis population, defined as (1) all patients who received the randomized treatment in full, (2) completed the Month 3 efficacy assessments, and (4) did not have a major protocol deviation that could confound the assessment of efficacy as determined by a blinded, independent data review panel.|||score||Standard Deviation|Mean
1445369|NCT00889681|Primary|Long-term Clinical Success|Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.|180 days|78 of 81 subjects were treated with cryoablation.|||Participants|||Number
1445370|NCT00889681|Primary|Freedom From Major Atrial Fibrillation Events (MAFE)|Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.|365 days|78 of 81 enrolled subjects were treated with cryoablation.|||Participants|||Number
1445371|NCT00889681|Primary|Acute Procedural Success (APS)|Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.|At the conclusion of the cryoablation procedure|78 of 81 subjects were treated with cryoablation.|||Participants|||Number
1445372|NCT00889681|Primary|Cryoablation Procedure Events (CPEs)|Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.|365 days|78 of the 81 enrolled subjects were treated with cryoablation.|||Participants|||Number
1445450|NCT00888628|Secondary|Number of Participants With a Decrease in HbA1c|Subjects will have a decrease in HbA1c of at least >1%|1 year after subject's first islet transplant||||Participants|||Count of Participants
1445375|NCT00889603|Secondary|Number of Participants in Each Patient Domain of Benefit|Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated ‘yes’ and leaving a box blank indicated ‘no’).|Week 24|Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24.|||Participants|||Number
1445376|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS; LOCF. N=number of participants with evaluable data.|||Participants|||Number
1445377|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 24|FAS. N=number of participants with evaluable data.|||Participants|||Number
1445378|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 16|FAS. N=number of participants with evaluable data.|||Participants|||Number
1445379|NCT00889603|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8|CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8|FAS. N=number of participants with evaluable data.|||Participants|||Number
1445380|NCT00889603|Secondary|Change From Baseline in Functional Activity Questionnaire (FAQ)|Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.|Baseline and Week 24|FAS. Data not analyzed|||Scores on a scale||Standard Deviation|Mean
1445381|NCT00889603|Secondary|Change From Baseline in MMSE Total|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.|Baseline, Week 8, 16, and 24|FAS. N=number of participants with evaluable data.|||Scores on a scale||Standard Error|Least Squares Mean
1445382|NCT00889603|Primary|Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.|Baseline and Week 24|Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data.|||Scores on a scale||Standard Error|Mean
1445383|NCT00889512|Primary|The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG.||2 years||||number of follicles||Full Range|Median
1445384|NCT00889421|Secondary|Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment||7 months|||||||
1445385|NCT00889421|Primary|Reduction in Cystoid Macular Edema||6 months|||||||
1445386|NCT00889421|Primary|Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)||6 months|||||||
1445387|NCT00889421|Primary|Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%||6 months|||||||
1445388|NCT00889421|Primary|Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye||6 months|||||||
1445389|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) post-dose, pre-allergen challenge||||eyes|Participants||Number
1445390|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 4 (Day 14) pre-dose, pre-allergen challenge||||eyes|Participants||Number
1445391|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) post-dose, pre-allergen challenge||||eyes|Participants||Number
1445392|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 3 (Day 0) pre-dose, pre-allergen challenge||||eyes|Participants||Number
1445393|NCT00889330|Other Pre-specified|Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14|The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus|Visit 2 (Day -14) pre-allergen challenge||||eyes|Participants||Number
1445394|NCT00889330|Other Pre-specified|Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14|The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve|Visit 4 (Day 14) pre-dose, pre-allergen challenge||||eyes|Participants||Number
1445396|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge|The number of eyes with any change in visual acuity measurements compared to Day -21|Visit 3 (Day 0) pre-dose, pre-allergen challenge||||eyes|Participants||Number
1445397|NCT00889330|Other Pre-specified|Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14|The number of eyes with any change in visual acuity measurements compared to Day -21.|Visit 2 (Day -14) pre-allergen challenge||||eyes|Participants||Number
1445398|NCT00889330|Primary|Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 4 (Day 14) At 20 minutes following Allergen Challenge||||units on a scale||Standard Deviation|Mean
1445399|NCT00889330|Primary|Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation|"0 to 4 scale, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub"|Visit 4 (Day 14) up to 7 minutes following Allergen Challenge||||units on a scale||Standard Deviation|Mean
1445400|NCT00889330|Primary|Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation|"A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment||||units on a scale||Standard Deviation|Mean
1445401|NCT00889330|Primary|Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.|"A 0 to 4 scale used, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation."|Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge||||units on a scale||Standard Deviation|Mean
1445402|NCT00889265|Secondary|Mean Wound Healing Index at 6 Months|"Score Description~Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence~Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration~Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration"|6 months||||units on a scale||Standard Deviation|Mean
1445403|NCT00889265|Primary|Change in Horizontal Ridge Widths From Baseline to 6 Months|The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.|6 months||||mm||Standard Deviation|Mean
1445404|NCT00889252|Primary|Visual Acuity Assessment|Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.|at the 12 week visit|Subjects that completed the study per protocol were included in this analysis.|||Eyes|Participants||Number
1445405|NCT00889252|Primary|Dilated Ophthalmoscopy - Vitreous, Change From Baseline|Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445406|NCT00889252|Primary|Dilated Ophthalmoscopy - Fundus, Change From Baseline|Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445407|NCT00889252|Primary|Intraocular Pressure - Change From Baseline||baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||mm of mercury|Participants|Standard Deviation|Mean
1445408|NCT00889252|Primary|Corneal Staining - Central, Change From Baseline|Assessment of changes to the surface of the cornea, the central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445409|NCT00889252|Primary|Corneal Staining - Superior, Change From Baseline|Assessment of changes to the surface of the cornea, the upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445410|NCT00889252|Primary|Corneal Staining - Inferior, Change From Baseline|Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445411|NCT00889252|Primary|Corneal Staining - Temporal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445412|NCT00889252|Primary|Corneal Staining - Nasal, Change From Baseline|Assessment of changes to the surface of the cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445413|NCT00889252|Primary|Cells in Anterior Chamber, Change From Baseline|Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445414|NCT00889252|Primary|Flare in Anterior Chamber, Change From Baseline|Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445415|NCT00889252|Primary|Lens Pathology, Change From Baseline|Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445416|NCT00889252|Primary|Corneal Endothelial, Change From Baseline|Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445417|NCT00889252|Primary|Corneal Erosion, Change From Baseline|Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445418|NCT00889252|Primary|Corneal Edema, Change From Baseline|Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445419|NCT00889252|Primary|Conjunctival Chemosis, Change From Baseline|Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445420|NCT00889252|Primary|Conjunctival Redness, Change From Baseline|Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445421|NCT00889252|Primary|Lid and Lid Margin Swelling, Change From Baseline|Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445422|NCT00889252|Primary|Lid and Lid Margin Erythema, Change From Baseline|Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe|baseline and 12 weeks|Subjects that completed the study per protocol were included in this analysis.|||Units on a scale|Participants|Standard Deviation|Mean
1445423|NCT00889200|Primary|Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)|Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).|post drug (6 weeks oral eszopiclone)|All subjects completed all study procedures|||nmol/L|paired t-test cortisol reactivity|Standard Deviation|Mean
1445424|NCT00889187|Secondary|Surgical Mortality Rate [Phase II]|The proportion of patients with a death related to the surgery (CTCAEv3 attribution possible, probable, definite).|Assessed up to 30 days after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
1445425|NCT00889187|Secondary|Surgical Morbidity Rate [Phase II]|The proportion of patients experienced any grade 3-4 adverse event based on CTCAEv3 related to the surgery (attribution possible, probable, definite) as reported on case report forms.|Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
1445426|NCT00889187|Secondary|Progression-Free Survival (PFS) [Phase II]|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Patients alive whose disease had not progressed are censored at date of last disease evaluation|Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
1445427|NCT00889187|Secondary|Pathologic Response Rate [Phase II]|Pathologic response rate is the proportion of patients with the pathologic specimen absent any viable tumor cell. Pathological review of the pancreaticoduodenectomy specimen will be performed according to the AJCC Staging Classification, 6th edition. Initial gross evaluation and identification of resection margins will be performed jointly by the surgeon and the pathologist.|Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
1445428|NCT00889187|Secondary|Local Recurrence Rate [Phase II]|Local recurrence rate is defined as the proportion of patients with evidence of tumor recurrence within the radiation field based on RECIST criteria. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
1445429|NCT00889187|Primary|Grade 3-5 Toxicity Rate [Phase II]|All Grade 3-5 events based on CTCAEv3 related to the accelerated dose (attribution possible, probable, definite) as reported on case report forms.|within 3 weeks of the start of chemoradiation therapy|The study did not proceed to phase II due to unexpected intraoperative complications experienced by patients enrolled on phase I.||||||
1445430|NCT00889187|Primary|Dose Limiting Toxicity (DLT) [Phase I]|DLT occurring within 3 weeks of the start of chemoradiation therapy was defined as: Grade 3 non-hematologic or hematologic toxicity requiring interruption of >7 days (d) of chemo or >3d chemoradiation; Grade 4 non-hematologic; Grade 4 neutropenia or thrombocytopenia; Treatment-related death; Delays in surgery >3 weeks due to treatment-related toxicity. A 30% increase in any surgical complication rate beyond those previously established rates (readmission rate: 16%; pancreatic fistula/intra-abdominal abscess/infection rate: 27%, major intra-abdominal bleeding requiring return to OR: 1.6%, delayed gastric emptying: 4.4%, and superficial wound infection rate: 8%) was also considered a DLT.|within 3 weeks of the start of chemoradiation therapy|The analysis dataset is comprised of all treated patients.|||patients with DLT|||Number
1445431|NCT00889187|Primary|Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I]|Neoadjuvant short-course photon radiation therapy MTD in combination with capecitabine 825 mg/m2 orally BID for ten consecutive weekdays, beginning on the morning of the first day of radiation therapy is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If none of 3 initial patients or only 1 of 6 patients have a DLT on dose level 3 then 6 additional patients are treated at this dose. If during this expansion, the rate of DLT exceeds 30% then the next lower dose level is declared the MTD. If no DLTs are observed, the MTD is not reached.|within 3 weeks of the start of chemoradiation therapy|The analysis dataset is comprised of all treated patients.|||Gy per fraction|||Number
1445432|NCT00888979|Secondary|Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.||Baseline to 4 weeks||||reduction in number of CPD||Standard Deviation|Mean
1445433|NCT00888979|Secondary|Cartridge Use||Baseline to 4 weeks||||cartridges per day||Standard Deviation|Mean
1445434|NCT00888979|Primary|Number of Days of Inhaler Use||Baseline to 4 weeks||||days||Standard Deviation|Mean
1445435|NCT00888940|Secondary|Treatment-emergent Adverse Events.||Over the duration of the study.|Safety population analyzed|||events|||Number
1445436|NCT00888940|Primary|Cumulative Volume of Packed Red Blood Cells Transfused||12 hours after the end of surgery|Modified Intent to Treat = all subjects received at least one dose and analyzed according to planned treatment assignment. 3 subjects in ecallantide group not included due to no value being present|||mL||Standard Deviation|Mean
1445437|NCT00888849|Primary|Return to Bowel Activity||Number of days post-surgery to appearance of peristaltic movement||||days||Standard Error|Mean
1445438|NCT00888849|Primary|Time of Anastomosis||Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)||||minutes||Standard Error|Mean
1445439|NCT00888849|Primary|Time of Surgery (Skin Open to Skin Close)||Day 1|Intent-to-Treat|||minutes||Standard Error|Mean
1445440|NCT00888654|Secondary|Levels of Androgen Receptor in Prostate Tissue|Levels of androgen receptor in prostate tissue as measured by AR score (intensity x % cells stained), higher scores indicate higher levels of androgen receptor in prostate tissue.|Pre and post radical prostatectomy|All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.|||AR score (intensity x % cells stained)||90% Confidence Interval|Mean
1445441|NCT00888654|Secondary|Serum Levels of PSA, Testosterone, and Diindolylmethane|Serum levels of PSA, testosterone, and diindolylmethane (DIM)|Pre and post radical prostatectomy|All enrolled patients except for one patient who was deemed ineligible due to a disallowed concomitant medication and for one patient whose prostatectomy was cancelled because of adhesions found at the time of surgery.|||ng/ml||Full Range|Median
1445442|NCT00888654|Primary|Mean Level of Diindolylmethane in Prostate Tissue After Treatment||Within the first 24 months after radical prostatectomy.|Patients that were eligible, evaluable, and compliant|||ng/g||90% Confidence Interval|Mean
1445443|NCT00888628|Secondary|Reduction of Insulin Requriements|Evidence of partial success will be considered for subjects who have a reduction in insulin requirements but who are not insulin independent. This will be assessed by comparing the pre-transplant insulin requirement expressed as insulin units per kg per day with the requirement preceding subsequent islet transplants and the insulin requirements at 6 months and 1, 2, and 3 years after the first and last transplant.|1 year after the subject's first islet transplant||||Participants|||Count of Participants
1445444|NCT00888628|Secondary|Number of Participants With a Decrease of Severe Hypoglycemic Events|Subjects will have a decrease in severe hypoglycemic events|1 year after subject's first transplant||||Participants|||Count of Participants
1445445|NCT00888628|Secondary|Improvement of Metabolic Control|"Whether there is an improvement in metabolic control in IAK will be evaluated based on improvement in~basal c-peptide levels,~MMTT,~insulin requirements, and~c-peptide to glucose, creatinine ratio (CPGCR)."|1 year after the subject's first islet transplant||||Participants|||Count of Participants
1445446|NCT00888628|Secondary|Absence of Negative Renal Impact Measures|Loss of allograft survivial (return to dialysis, retransplant, death) and Renal allograft function meausred by SCr|1 year after the subject's first islet transplant||||Participants|||Count of Participants
1445447|NCT00888628|Secondary|Impact on Vision|Improvement of frequency of interventions and from changes in reported visual acuity with optical refraction and severity of diabetic retinopathy|1 year after the subject's first islet transplant||||Participants|||Count of Participants
1445448|NCT00888628|Secondary|An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction||1 year after the subject's first islet transplant||||Participants|||Count of Participants
1445449|NCT00888628|Secondary|Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine|Proteinuria and serum creatinine will be stable or decreased as compared to pre-transplant values|1 year after subjects initial islet transplant||||Participants|||Count of Participants
1445451|NCT00888628|Primary|Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.||1 year after the subject's first islet transplant||||participants|||Number
1445452|NCT00888459|Primary|Number of Participants With Tobacco Abstinence|self-reported 7-day point prevalence tobacco abstinence at week 12 (end of treatment)|12 weeks|intention to treat|||participants|||Number
1445453|NCT00888433|Primary|Office Systolic Blood Pressure Reduction|The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.|Baseline to 6 months||||mmHg||Standard Deviation|Mean
1445454|NCT00888381|Secondary|The Incidence of Any Unsolicited Adverse Events (AEs).|"The number of participants reporting any unsolicited adverse events.~Unsolicited adverse event (UAE) grading:~Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities."|After vaccination until the end of the study; approximately 21 days|The Safety Population comprised all participants who received study vaccine.|||participants|||Number
1445455|NCT00888381|Secondary|The Frequency of Any Solicited Systemic Symptoms.|The number of participants reporting any solicited systemic symptoms.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.|||participants|||Number
1445456|NCT00888381|Secondary|The Frequency of Any Solicited Local Reactions.|The number of participants reporting any solicited local reactions.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population comprised all participants who received study vaccine.|||participants|||Number
1445457|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.||Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||percentage of participants||95% Confidence Interval|Number
1445458|NCT00888381|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||percentage of participants||95% Confidence Interval|Number
1445459|NCT00888381|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population comprised all participants who were vaccinated with the study vaccine, provided both pre- and post-vaccination antibody titre results, and were not excluded from the analyses (eg, for the use of a prohibited medication or a laboratory-confirmed influenza virus infection between Visits 1 and 2).|||percentage of participants||95% Confidence Interval|Number
1445460|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to LAEs|Patients discontinued due to LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis|||Participants|||Number
1445461|NCT00888355|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related LAEs during the 12-week treatment period|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1445462|NCT00888355|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1445463|NCT00888355|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.|||Participants|||Number
1445464|NCT00888355|Other Pre-specified|Number of Patients Who Died|Patients who died during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1445465|NCT00888355|Other Pre-specified|Number of Patients Discontinued Due to CAEs|Patients discontinued due to CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1445466|NCT00888355|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1445467|NCT00888355|Other Pre-specified|Number of Patients With Serious CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1445485|NCT00888134|Secondary|Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip||Up to 4 years|Samples and data were not collected for this outcome.||||||
1445468|NCT00888355|Other Pre-specified|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|12 weeks|All patients who took study medication were included in the analysis.|||Participants|||Number
1445469|NCT00888355|Secondary|Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg or increased were in Category III.|24 hours after last morning dose and 12 hours after last PM dose at 12 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
1445470|NCT00888355|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours after last morning dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1445471|NCT00888355|Secondary|Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1445472|NCT00888355|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12|At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1445473|NCT00888329|Primary|Number of Participants With Emesis|This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.|24 hours after emergence from anesthesia|ITT. However, the primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group.|||participants|||Number
1445474|NCT00888238|Secondary|Glucose Infusion Rate (GIR) During 190 – 340 Minutes Post-dose|Glucose Infusion Rate required to maintain the target glucose level of 160 milligrams / deciliter (mg/dL) ; GIR was normalized to subject's body weight (kg).|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.|||mg / kg / min||Standard Deviation|Least Squares Mean
1445475|NCT00888238|Primary|Insulin Secretion Rate (ISR) During 190 – 340 Minutes Post-dose|ISR was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters.|190 minutes to 340 minutes|All subjects who completed a hyperglycemic clamp in each period were included in the analysis.|||ng/min||Standard Deviation|Least Squares Mean
1445476|NCT00888173|Other Pre-specified|Mutations in FGFR2 and PTEN|Will be correlated with PFS, overall survival (OS), tumor response, and histologic cell type.|Up to 5 years|||||||
1445477|NCT00888173|Other Pre-specified|IHC Expression of FGFR Family and Ligands, Steroid Receptor Isoforms, and pAKT|Will be correlated with PFS, OS, tumor response, and histologic cell type.|Up to 5 years|||||||
1445478|NCT00888173|Other Pre-specified|Change in Concentration of VEGF and Type IV Collagen|Will be correlated with PFS, OS, tumor response, and histologic cell type.|Baseline to up to pre-course 3|||||||
1445479|NCT00888173|Other Pre-specified|Activating Mutation in FGFR2|Will be correlated with clinical measures of outcome such as tumor response, progression-free survival (PFS), and endometrioid histology.|Up to 5 years|||||||
1445480|NCT00888173|Secondary|Severity of Adverse Events as Assessed by CTCAE v3.0 Criteria|Adverse Events (grade 3 or higher)|Up to 5 years|Eligible and Treated Patients|||Participants|||Count of Participants
1445481|NCT00888173|Secondary|Duration of Progression-free Survival|Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on progression-free survival will be examined.|Form study entry until disease progression, death or date of last contact, assessed up to 5 years|Eligible and Treated Patients|||months||90% Confidence Interval|Median
1445482|NCT00888173|Secondary|Duration of Overall Survival|Characterized graphically with Kaplan-Meier estimates and using descriptive statistics. The effect of cell type (type I versus type II endometrial cancers) on overall survival will be examined.|From entry into the study to death or the date of last contact, assessed up to 5 years|Eligible and Treated Patients|||months||90% Confidence Interval|Median
1445483|NCT00888173|Primary|Tumor Response|Per response evaluation criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30 % decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|If evaluated by physical exam, response was assessed prior to each cycle. If evaluated by CT or MRI, response was assessed during course of therapy. Overall time frame is up to 6 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1445484|NCT00888173|Primary|Progression-free Survival > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For patients whose disease can be evaluated by physical examination, progression was assessed prior to each cycle for 6 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1445486|NCT00888134|Secondary|Progression-free Survival|Reported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.|4 months||||percentage of participants||95% Confidence Interval|Number
1445487|NCT00888134|Secondary|Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers|Percentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.|Up to 4 years||||percentage of participants|||Number
1445488|NCT00888134|Secondary|AKT Pathway Activity|Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)|Up to 4 years|Samples and data were not collected for this outcome.||||||
1445489|NCT00888134|Primary|Objective Response Rate in Patients With Cancers Other Than Melanoma|Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).|4 years||||percentage of participants|||Number
1445490|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 3.6 - 26.4 Years||Baseline and 16 weeks|Subjects who had been diagnosed with PAH for 3.6 to 26.4 years prior to Baseline.|||meters||Inter-Quartile Range|Median
1445491|NCT00887978|Post-Hoc|6-minute Walk Distance by Years Since PAH Diagnosis: 1.8 - 3.5 Years||Baseline and 16 weeks|Subjects who were diagnosed with PAH between 1.8 and 3.5 years prior to Baseline.|||meter||Inter-Quartile Range|Median
1445492|NCT00887978|Post-Hoc|6-minute Walk Distance by Time Since PAH Diagnosis: 0.9 - 1.74 Years||16 Weeks|Subjects who had been diagnosed with PAH between 0.9 and 1.74 years prior to Baseline.|||meters||Inter-Quartile Range|Median
1445493|NCT00887978|Post-Hoc|6-minute Walk Distance by Time to PAH Diagnosis: 0 - 0.9 Years||Baseline and 16 weeks|Subjects who have been diagnosed with PAH between 0 to 0.9 years prior to Baseline.|||meters||Inter-Quartile Range|Median
1445494|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA + PDE-5i||16 weeks|Subjects receiving both an ERA and a PDE-5i at Baseline.|||meters||Inter-Quartile Range|Median
1445495|NCT00887978|Post-Hoc|6-minute Walk Test by Background PAH Therapy: ERA Only||Baseline and 16 weeks|Subjects who were only receiving an ERA at Baseline|||meters||Inter-Quartile Range|Median
1445496|NCT00887978|Post-Hoc|6-minute Walk Distance by Background PAH Therapy: PDE-5i Only||16 weeks|Subjects receiving only a PDE-5i at Baseline|||meters||Inter-Quartile Range|Median
1445497|NCT00887978|Post-Hoc|6-minute Walk Distance by PAH Etiology: Idiopathic PAH (IPAH) / Heritable PAH(HPAH)|Covariate analysis of change in 6MWD by PAH etiology, specifically idiopathic or heritable PAH|Baseline and 16 Weeks|Subjects with IPAH/HPAH|||meters||Inter-Quartile Range|Median
1445498|NCT00887978|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 16. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 16 Weeks|Subjects in countries where the CAMPHOR has not been validated in the local language were not included in these analyses. Additionally, only subjects with completed questionnaires at Baseline and Week 16 were analyzed.|||units on a scale||Inter-Quartile Range|Median
1445499|NCT00887978|Secondary|N-terminal proBNP (NT-proBNP)|Serum N-terminal pro-BNP concentration was assessed at Baseline and Week 16.|Baseline and 16 Weeks|Subjects who were missing Week 16 samples were not included in the analysis.|||pg/mL||Standard Deviation|Mean
1445500|NCT00887978|Secondary|Dyspnea Fatigue Index|The dyspnea-fatigue index was assessed at Baseline and Week 16. Each of the three components of the dyspnea-fatigue index were rated on a scale 0 to 4, with 0 being the worst condition and 4 being the best condition for each component. The dyspnea-fatigue index is computed by summing the three component scores.|Baseline and 16 Weeks|Subjects without a Dyspnea Fatigue Index score at Baseline were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1445501|NCT00887978|Secondary|Symptoms of PAH|Symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain and orthopnea were assessed by the physician at Baseline and Week 16. Severity grade values (i.e., 0, 1, 2 or 3) for each symptom were provided each subject. A severity of 0 indicated no symptoms, the maximum severity was 3, indicating severe symptoms. Mean change in symptom severity from Baseline to Week 16 is described.|Baseline and 16 Weeks|Subjects without Baseline assessments of PAH symptoms were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1445502|NCT00887978|Secondary|World Health Organization (WHO) Functional Class|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and 16 Weeks|Subjects with a WHO functional class assessment at Week 16|||participants|||Number
1445503|NCT00887978|Secondary|Borg Dyspnea Score|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and 16 Weeks|All subjects with a Baseline Borg Score were included in the analysis. One subject in the placebo group did not have a Baseline Borg Score recorded.|||score||Inter-Quartile Range|Median
1445504|NCT00887978|Secondary|Clinical Worsening Assessment|"Definition of clinical worsening included patients who met at least one of the following criteria during the 16 weeks of study:~Death (all causes excluding accident)~Transplantation~Atrial septostomy~Hospitalization as a result of right heart failure~Greater than or equal to a 20% decrease in 6MWD from Baseline (or too ill to walk) AND addition of an inhaled prostacyclin analogue, ERA, or PDE-5i~Initiation of parenteral prostacyclin therapy (i.e., epoprostenol, iloprost, or treprostinil) for the treatment of PAH"|Baseline and 16 Weeks|Intention to treat analysis|||number of clinical worsening events|||Number
1445505|NCT00887978|Primary|6-minute Walk Distance (6MWD)|"Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).~The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies)."|Baseline and 16 weeks|Intention to treat analysis|||meters||Inter-Quartile Range|Median
1445506|NCT00887965|Secondary|Procollagen Type 1 N-terminal Peptide (P1NP)|Procollagen Type 1 N-terminal Peptide is a biochemical marker of bone turnover. Blood samples were drawn for assessment of P1NP levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy|||μg/L||Inter-Quartile Range|Median
1445507|NCT00887965|Secondary|C-Telopeptide (CTX-1)|C-Telopeptide is a biochemical marker for bone turnover. Blood samples were drawn for assessment of CTX-1 levels on either Day 3 or Day 20, within 24 hours of the last dose of the respective tetracycline cycle.|Day 3 or Day 20|All enrolled patients with at least one evaluable biopsy|||ng/mL||Inter-Quartile Range|Median
1445508|NCT00887965|Secondary|Bone Histomorphometry: Mineralization Lag Time|The mineralization lag time is the time interval between osteoid secretion and its subsequent mineralization, in days.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||days||Inter-Quartile Range|Median
1445509|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Volume|Osteoid volume is expressed as a percentage of total bone volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of total volume||Inter-Quartile Range|Median
1445510|NCT00887965|Secondary|Bone Histomorphometry: Activation Frequency|The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency (Ac.f). Activation frequency is calculated as the bone formation rate / wall width.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||/year||Inter-Quartile Range|Median
1445511|NCT00887965|Secondary|Bone Histomorphometry: Formation Period|The formation period is the duration of an interval when a place on the bone surface is actively forming bone. The formation period is calculated as the wall width (thickness of new bone made in one cycle) divided by the mineral apposition rate.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||days||Inter-Quartile Range|Median
1445512|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Volume Based|Bone formation rate - volume based (BFR/BV) is the calculated rate at which cancellous bone volume is being replaced annually. BFR/BV is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percent of bone volume per year||Inter-Quartile Range|Median
1445513|NCT00887965|Secondary|Bone Histomorphometry: Bone Formation Rate - Surface Based|Bone formation rate - surface based (BFR/BS) is the calculated rate at which cancellous bone surface is being replaced annually. BFR/BS is derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface /total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm^3 /μm^2 /year||Inter-Quartile Range|Median
1445514|NCT00887965|Secondary|Bone Histomorphometry: Adjusted Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm/day||Inter-Quartile Range|Median
1445515|NCT00887965|Secondary|Bone Histomorphometry: Mineral Apposition Rate|The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm/day||Inter-Quartile Range|Median
1445516|NCT00887965|Secondary|Bone Histomorphometry: Total Mineralizing Surface|Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
1445517|NCT00887965|Secondary|Bone Histomorphometry: Double-label Surface|Double-label surface is expressed as a percentage of total bone surface. The presence of double labels indicates that normal bone mineralization was actively occurring over the labeling interval.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
1445518|NCT00887965|Secondary|Bone Histomorphometry: Single-label Surface|Single-label surface is expressed as a percentage of total bone surface. The presence of a single label indicates that mineralization was occurring during only one labeling period.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
1445519|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Surface Based|Osteoclast number expressed per bone surface area. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||1/100 mm||Inter-Quartile Range|Median
1445520|NCT00887965|Secondary|Bone Histomorphometry: Osteoclast Number - Length Based|Osteoclast number expressed per mm of bone. Osteoclast number was measured using fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||1/mm||Inter-Quartile Range|Median
1445521|NCT00887965|Secondary|Bone Histomorphometry: Eroded Surface/Bone Surface|Eroded surface is expressed as a percentage of total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
1445864|NCT00885703|Secondary|Number of Hospital Admissions|Count of number of times a participant was admitted to the hospital.|Measured from study entry through Week 24|Arms pooled by dose in safety population (see study detailed description for details).|||Participants|||Count of Participants
1445522|NCT00887965|Secondary|Bone Histomorphometry: Wall Thickness|Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
1445523|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Width|Osteoid thickness (width; O.Th) is the mean thickness of osteoid seams on cancellous surfaces. O.Th is normally <12.5 µm. Increased O.Th suggests abnormal mineralization (osteomalacia).|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
1445524|NCT00887965|Secondary|Bone Histomorphometry: Osteoid Surface|Osteoid surface is expressed as a percentage total bone surface.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of bone surface||Inter-Quartile Range|Median
1445525|NCT00887965|Secondary|Bone Histomorphometry: Osteoblast - Osteoid Interface|Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||percentage of osteoid surface||Inter-Quartile Range|Median
1445526|NCT00887965|Secondary|Bone Histomorphometry: Surface Density|Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||mm^2 /mm^3||Inter-Quartile Range|Median
1445527|NCT00887965|Secondary|Bone Histomorphometry: Cortical Width|Cortical width correlates with dual photon absorptiometric (DPX) measurements of bone density.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
1445528|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Thickness|Mean trabecular thickness (Tb.Th) is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Tb.Th is reduced by aging and osteoporosis.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
1445529|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Separation|Trabecular separation (Tb.Sp) is the mean distance in mm between trabeculae (measured by integrated computer graphics). Tb.Sp increases with trabecular bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||μm||Inter-Quartile Range|Median
1445530|NCT00887965|Secondary|Bone Histomorphometry: Trabecular Number|Trabecular number (Tb.N) is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Tb.N is a measure of trabecular connectivity and decreases with bone loss.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry.|||mm^-1||Inter-Quartile Range|Median
1445531|NCT00887965|Secondary|Bone Histomorphometry: Cancellous Bone Volume|Cancellous (trabecular) bone volume (Tb.V) is the relative volume of total cancellous bone measured (TV), expressed as percentage, that is occupied by trabeculae. Cancellous bone volume was measured using Fluorochrome labeling with tetracyclene and tartrate-resistant acid phosphatase stain (TRAP) staining techniques.|25-34 days post-Day 1|All enrolled patients with at least one biopsy evaluable for histomorphometry|||percentage of total volume||Inter-Quartile Range|Median
1445532|NCT00887965|Primary|Number of Participants With Normal/Abnormal Bone Histology|The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.|25-34 days post-Day 1|All enrolled patients who had at least one evaluable biopsy|||Participants|||Number
1445533|NCT00887913|Primary|Improvement in Brightness|"Assess the improvement in brightness of the treated anatomical area using Improvement Scale where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up post last treatment|Per protocol, each anatomical area treated was assessed for skin brightness using the Improvement Scale of 0-4 where 0= 0%, 1= 1-25%, 2=26-50%, 3=51-75%, 4= 76-100% based on before and photographs. Maximum value grade is 4 and the minimum value grade is 0.|||Scores on a scale|Participants|Standard Deviation|Mean
1445534|NCT00887913|Primary|Improvement in Smoothness|"Smoothness of anatomical treated area assessed based on Improvement Scale 0-4.Where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 weeks follow up post last treatment|Analysis was per protocol, each area treated was graded on its improvement regarding the smoothness of the skin|||Scores on a scale|Participants|Standard Deviation|Mean
1445535|NCT00887913|Primary|Improvement in Fine Lines|"Improvement of fine lines (wrinkles) assessed per anatomical area treated based on Improvement Scale: 0-4 where higher scores indicate a better outcome.~Improvement is graded by means of photographs taken at baseline vs treatment 3 and baseline vs 6week follow up"|4 week follow up after last treatment|Per protocol each defined anatomical area treated was assessed for improvement according to Improvement Scale- 0-4|||Scores on a scale|Participants|Standard Deviation|Mean
1445536|NCT00887822|Secondary|Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time|The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|From Cycle 1 until disease progression (up to 26 months)|ITT population|||scores on scale||95% Confidence Interval|Mean
1445556|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)|"Scoring:~Participants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant."|baseline and 7 weeks||||units on a scale||Standard Deviation|Mean
1445537|NCT00887822|Secondary|Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time|EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.|From Cycle 1 until disease progression (up to 26 months)|ITT population|||scores on scale||95% Confidence Interval|Mean
1445538|NCT00887822|Secondary|Percentage of Participants With Disease Control During First-Line Therapy|Disease control was defined as stable disease(SD) for 6 weeks or longer, CR plus PR as assessed by RECIST criteria for participants with measurable disease.CR:disappearance of all TLs & normalization of tumor markers. Pathological lymph nodes must have short axis measures<10 mm. PR:at least 30% decrease in sum of measures(longest diameter for tumor lesions and short axis measure for nodes)of TLs, taking as reference baseline sum of longest diameters.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression taking as reference smallest sum of longest diameters on study. For participants without measurable disease, clinical benefit rate was defined as no clinical disease progression for >/=6 weeks. Disease progression was defined as at least 20% increase in sum of diameters of TLs compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants||95% Confidence Interval|Number
1445539|NCT00887822|Secondary|Duration of Response During First-Line Therapy|Duration of response during first-line therapy was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death (whichever occurs first) during first-line therapy. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters. Duration of response was estimated using Kaplan Meier method. Reported data included censored observations. Participants who did not progress or die after they had had a confirmed response were censored at the date of their last tumor measurement or last follow-up for progression of disease during first line therapy.|From randomization until disease progression or death (up to 26 months)|Measurable disease population|||months||95% Confidence Interval|Median
1445540|NCT00887822|Secondary|Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy|Best overall response during first-line therapy was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR), as assessed by the RECIST criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm. PR: at least a 30 % decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of longest diameters.|From randomization until disease progression or death (up to 26 months)|Measurable disease population included all randomized participants who had measurable disease at baseline according to RECIST.|||percentage of participants||95% Confidence Interval|Number
1445541|NCT00887822|Secondary|Time to Progression|Time to progression was defined as the time between randomization and the first occurrence of disease progression. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Time to progression was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had not progressed at the time of study completion (including participants who had died before disease progression) or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population|||months||95% Confidence Interval|Median
1445542|NCT00887822|Secondary|Percentage of Participants With Disease Progression|Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants|||Number
1445543|NCT00887822|Secondary|PFS During First-line Therapy|PFS during first-line therapy was defined as time between randomization and date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last intake of any study medication and only if it occurred before start of non-study antineoplastic treatment, according to RECIST. Progression of disease was defined as at least 20% increase in sum of longest diameters of target lesions compared to smallest sum of longest diameters on-study & absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who neither progressed nor died in this interval, or who were lost to follow-up were censored at date of last tumor assessment/last follow-up within this time window. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population.|||months||95% Confidence Interval|Median
1445544|NCT00887822|Secondary|Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy|Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS during first-line therapy was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first and only if it occurred no later than 28 days after last confirmed intake of any study medication and before the start of non-study antineoplastic treatment, according to RECIST.|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants|||Number
1445545|NCT00887822|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to RECIST. Progression of disease was defined as at least 20% increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method. Reported data included censored observations. Participants who had neither progressed nor died at the time of study completion or who were lost to follow-up were censored at the date of the last tumor assessment or last follow-up for progression of disease. Participants for whom no post-baseline tumor assessments were available were censored at day of randomization.|From randomization until disease progression or death (up to 26 months)|ITT population|||months||95% Confidence Interval|Median
1445546|NCT00887822|Secondary|Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)|Progression of disease was defined as at least 20 percent (%) increase in the sum of longest diameters of target lesions compared to the smallest sum of longest diameters on-study and absolute increase of at least 5 millimeters (mm), progression of existing non-target lesions, or presence of new lesions. PFS was defined as the time between randomization and the date of first documented disease progression or death, whichever occurred first, according to Response Evaluation Criteria In Solid Tumors (RECIST).|From randomization until disease progression or death (up to 26 months)|ITT population|||percentage of participants|||Number
1445547|NCT00887822|Primary|Overall Survival|Overall survival was defined as the time between randomization and the date of death due to any cause. Overall survival was estimated using Kaplan Meier method. Reported data included censored observations. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. As planned, ad hoc analysis was done for overall survival up to clinical clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months).|From randomization until death (up to 34 months)|ITT population|||months||95% Confidence Interval|Median
1445548|NCT00887822|Primary|Percentage of Participants With Event (Death)|Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause.|From randomization until death (up to 34 months)|ITT population|||percentage of participants|||Number
1445549|NCT00887809|Primary|Overall Objective Response|Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|6 months||||participants|||Number
1445550|NCT00887744|Secondary|Proportion of Patients Having Procedure and/or Device Related Events During the Complete 12 Month Follow-up Period.||From baseline up to 12 months follow up||||Proportion of patients (%)|||Number
1445551|NCT00887744|Secondary|Mean Change in Quality of Life Score at 12 Months Compared to Baseline|The quality of life scale covers five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels (no health problems,moderate health problems,extreme health problems). The distribution of the response of the patients in these five dimensions was to be studied.This descriptive system was converted into a weighted health state index with Min-max score = 0-100 and 100 as most optimal score. If one or more questions are left unanswered, the questionnaire is not scored.|From baseline up to 12 months follow up||||Scores on a scale (1-100)||Standard Deviation|Mean
1445552|NCT00887744|Secondary|Mean Percentage Change in Physical Function at 12 Months Compared to Baseline, Using the Zurich Claudication Questionnaire|"The Zurich Claudication Questionnaire – Physical Function score is the unweighted mean of six physical function questions ranging from 1 to 4. The six Physical Function questions ask about walking distance and ability to walk for pleasure, for shopping, and for getting around the house or apartment and from bathroom to bedroom. If more than one item was missing, the scale score was also to be considered as missing. The possible range of this score is 1.0 to 4.0.~The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months||||Percent Change||Standard Deviation|Mean
1445553|NCT00887744|Secondary|Mean Percentage Change in Symptom Severity at 12 Months Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|"The Zurich Claudication questionnaire - Symptom Severity score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).This score is the unweighted mean of all answered items (missing scores are discarded). Scoring range= 1-5.~The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage."|From baseline up to 12 months follow up||||Percent Change||Standard Deviation|Mean
1445554|NCT00887744|Primary|The Proportion of Patients Experiencing a Procedure or Device Related Serious Adverse Events During the First 7 Days Starting at the Surgical Procedure|"Adverse events were to be summarized by proportion. All Adverse events occurring within the first 7 days after the surgical procedure were to be analyzed:~Day of the procedure until P+1 (where P refers to the day of the surgical procedure)~P+2 until P+7"|Starting at the surgical procedure till 7 days post-operatively||||Proportion of patients (%)|||Number
1445555|NCT00887744|Primary|Mean Percentage Change in Symptom Severity at 6 Weeks Compared to Baseline, Using the Patient Completed Zurich Claudication Questionnaire for Symptom Severity|This score is based on seven questions (overall pain,pain frequency,pain in the back,pain in the leg,numbness,weakness,and balanced disturbance.The first 6 categories are scored 1 to 5 (none,mild,moderate, severe,very severe). Balance disturbance is scored in a 1-3-5 scale (None,sometimes,often).The symptom severity scale score is the unweighted mean of all answered items (missing scores are discarded) in the questionnaire. Scoring range= 1-5.The change is calculated as the scores at the later timepoint minus the earlier timepoint expressed in terms of percentage.|From baseline up to 6 weeks follow-up|Intention-To-Treat: the population of patients who underwent the minimally invasive procedure.|||Percent change||Standard Deviation|Mean
1445557|NCT00887679|Secondary|Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)|Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.|baseline and 7 weeks||||units on a scale||Standard Deviation|Mean
1445558|NCT00887679|Secondary|Change From Randomization to End of Treatment for Trail Making Tet (TMT)|"Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.~Average =29 seconds, Deficient > 78 seconds"|baseline to 7 weeks||||seconds||Standard Deviation|Mean
1445559|NCT00887679|Secondary|Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)|"Scale for scoring:~Clinical Global Impression(CGI-S)~= Normal, no symptoms~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Most extremely ill~Clinical Global Impression(CGI-I)-improvement since treatment~very much improved~much improved~minimally improved~no change from baseline~minimally worse~much worse~very much worse"|baseline and 7 weeks|3 patients dropped out, 4 patients did not meet criteria, and 3 patients did not show up.|||scores on a scale||Standard Deviation|Mean
1445560|NCT00887679|Primary|Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory|"Scoring~The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:~(0) I do not feel sad.~I feel sad.~I am sad all the time and I can't snap out of it.~I am so sad or unhappy that I can't stand it.~A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[6] 0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms."|baseline and 7 weeks||||units on a scale||Standard Deviation|Mean
1445561|NCT00887679|Primary|Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)|The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.|baseline and 7 weeks|3 patients dropped out, 4 patients did not met the criteria, and 3 patients did not show up.|||scores on an anxiety scale||Standard Deviation|Mean
1445562|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 6 months|6 months||||units on a scale||Full Range|Median
1445563|NCT00887653|Secondary|Proportion of Patients With Plasma Viral Load Below the Limit of Detection|Assess proportion of patients with PVL below limit of detection at end of study.|6 months|One subject was prematurely discontinued from the study at week 12 due to detectable HIV-1 RNA of 57 copies/mL that was sustained at 61 copies on repeated measurement two weeks later.|||proportion of participants|||Number
1445564|NCT00887653|Primary|Change From Baseline Triglycerides|Assess changes from baseline triglycerides at 3 months|3 months||||units on a scale||Full Range|Median
1445565|NCT00887640|Secondary|Safety and Tolerability of Temsirolimus|Total number of grade 3, 4, and 5 adverse events at least possibly related to temsirolimus therapy. Adverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to 4.0 for the purposes of reporting to ClinicalTrials.gov.|2 years||||Adverse Events|||Number
1445566|NCT00887640|Secondary|Change Over Time in CTC Gene Expression Profile|Percent change in CTC gene expression from baseline to 8 or 12 weeks of treatment.|12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.||||||
1445567|NCT00887640|Secondary|Time to Second PSA Progression After Addition of Anti-androgen Therapy|Time in months from the time of anti-androgen therapy to the date of second PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to second PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. Patients progressed radiographically before 2nd PSA progression occurred.||||||
1445568|NCT00887640|Secondary|Time to PSA Progression|Time in months from the start of study treatment to the date of first PSA progression . Patients alive who had not progressed as of the last follow-up or patients who had expired had time to PSA progression censored at the last follow-up date or death date. The median was estimated using a Kaplan-Meier curve.|2 years|Data were insufficient to evaluate this outcome. Data not collected. PSA responses were not observed in this study and PSA progression dates would essentially be the same as the radiographic PFS dates.||||||
1445569|NCT00887640|Secondary|Maximum Rate of Change of Prostate-Specific Antigen (PSA).|Percent change in PSA between baseline and the measurement time point where the largest change in PSA occurred. Note that a positive change (greater than 0) indicates an increase in PSA, and a negative change (less than 0) indicates a decrease.|Baseline to 7 months||||Percent change||Full Range|Median
1445570|NCT00887640|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Clinical Trial Working Group 2 (PCWG2) criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Additionally, according to PCWG2 criteria, disease progression in bone is defined as 2 or more new lesions seen on bone scan compared with the baseline scan used for trial entry. Per PCWG2 guidelines, therapy was not discontinued solely due to a rise in PSA alone.|2 years||||Months||95% Confidence Interval|Median
1446654|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Possible Sleep Disturbance of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of sleep disturbance.|two days||||scores|Participants|Standard Deviation|Mean
1445571|NCT00887640|Secondary|Percent Change in LDH|To evaluate and correlate changes in serum Lactate Dehydrogenase (LDH) with CTC count changes over time in men with Castrate Resistant Prostate Cancer (CRPC) treated with temsirolimus|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Data not collected. This outcome was not performed due to availability and feasibility of the tests involved.||||||
1445572|NCT00887640|Secondary|Mean Percent of N-cadherin Expression at Baseline and 8 Weeks of Treatment.|Measures of epithelial plasticity on CTCs in response to Mammalian Target of Rapamycin (mTOR) inhibition with temsirolimus, using genomic and protein immunohistochemical methodology. N-cadherin was measured in CTCs captured using the CellSearch profile kit. The proportion of CTCs expressing N-cadherin was calculated and divided by the total number of CD45-negative, pan cytokeratin (CK) – positive, and 4’,6-diamidino-2-phenylindole (DAPI+) intact cells to give a fractional expression of N-cadherin. Results are reported as a percentage.|Baseline and 8 weeks|N-cadherin expression at both baseline and 8 weeks was evaluable in 7 patients.|||Percent expression||Full Range|Median
1445573|NCT00887640|Secondary|Percent Change in CTC Count From Baseline to 12 Weeks of Treatment.|To evaluate the change in CTC counts upon the addition of an anti-androgen upon PSA progression while on temsirolimus therapy|Baseline to 12 weeks|Data were insufficient to evaluate this outcome. Outcome not available at 12 weeks. CTCs were not collected at week 12 and thus were not analyzed.||||||
1445574|NCT00887640|Primary|Change in Circulating Tumor Cell (CTC) Counts in Men With Metastatic Treatment-refractory Castration-resistant Prostate Cancer.|Median percent change in CTC count from baseline to 8 weeks of treatment. Percent change was calculated by determining the percentage increase or decrease in CTC count from baseline.|Baseline to 8 weeks|CTC count at both baseline and week 8 were assessable in 8 of the 11 patients as CTCs were collected at both time points in these patients. Missing CTC data for 3 of the 11 patients due to laboratory error or no CTC available at various time points.|||percent change||Inter-Quartile Range|Median
1445575|NCT00887588|Secondary|Change From Baseline in Sitting SBP, Sitting DBP and Sitting Pulse Pressure (PP)|Sitting blood pressure and sitting pulse pressure were assessed. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||mmHg||Standard Error|Least Squares Mean
1445576|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Pulse Wave Velocity|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||cm/s||Standard Error|Least Squares Mean
1445577|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||bpm||Standard Error|Least Squares Mean
1445578|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Heart Rate Correct Cen Aug/Pulse Ht|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||Percent||Standard Error|Least Squares Mean
1445579|NCT00887588|Secondary|Change From Baseline in Arterial Stiffness Parameters: Brachial Systolic Blood Pressure (SBP), Brachial Diastolic Blood Pressure (DBP), Central Augmentation Pressure, Central Pressure at T1-DP, Central SBP, Central DBP, Central Mean Pressure|A vascular arterial stiffness sub-study was conducted in a subset of participants. Noninvasive arterial tonometry was assessed using the Sphygmor device. Participants had arterial stiffness, pulse wave velocity and central pressures measured. A negative change from baseline indicates improvement.|baseline, 36 weeks|Participants from the arterial stiffness set, who had values for both baseline and week 36, were analyzed. The arterial stiffness set included randomized participants who participated in the arterial stiffness sub-study.|||mmHg||Standard Error|Least Squares Mean
1445580|NCT00887588|Secondary|Change From Baseline in Albumin/Creatinine Ratio|Evaluation of albumin/creatinine was performed by central laboratory. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio||95% Confidence Interval|Geometric Mean
1445581|NCT00887588|Secondary|Change From Baseline in Serum Creatinine|Evaluation of serum creatinine was performed by central laboratory. A negative change from baseline indicates improvement.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||µmol/L||Standard Error|Least Squares Mean
1445582|NCT00887588|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|eGFR was calculated from the serum creatinine concentration determined by central laboratory assessment. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
1446890|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 1||||mmHg||Standard Error|Least Squares Mean
1445583|NCT00887588|Secondary|Percentage of Participants With New York Heart Association (NYHA) Class I, II, II or IV|The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases.|baseline, 36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||Percentage of participants|||Number
1445584|NCT00887588|Secondary|Percentage of Participants With Clinical Composite Assessment of Improved, Unchanged or Worsened|The clinical composite assessment is defined as follows: Improved = a) participant improved (markedly or moderately) in the global assessment of disease activity with no worsening of NYHA functional class and no major adverse cardiovascular event or b) participant improved in NYHA functional class with no worsening (markedly or moderately) in the global assessment of disease activity and no major adverse cardiovascular event. Worsened = participant worsened (markedly or moderately) in the global assessment of disease activity or in NYHA functional class or experienced a major adverse cardiovascular event. Unchanged = participant does not meet the definition for improved or worsened.|36 weeks|Extension efficacy set: the extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||Percentage of participants|||Number
1445585|NCT00887588|Secondary|Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score and Individual Domain Summary Scores|The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each domain, were included in the analysis for that domain. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||score on a scale||Standard Error|Least Squares Mean
1445586|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Tricuspid Regurgitation Velocity|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||m/s||Standard Error|Least Squares Mean
1445587|NCT00887588|Secondary|Change in Echocardiography Parameters: Isovolumic Relaxation Time|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ms||Standard Error|Least Squares Mean
1445588|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ratio of E to A Velocity, E/e' Ratio|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A ratio < 1 indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio||Standard Error|Least Squares Mean
1445589|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Ewave Velocity, A Wave Velocity, e' at Septal Mitral Annulus, e' at Lateral Mitral Annulus|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||cm/s||Standard Error|Least Squares Mean
1445590|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Atrial Volume Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ml/m^2||Standard Error|Least Squares Mean
1445591|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass Index|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||g/m^2||Standard Error|Least Squares Mean
1445592|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Mass|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||grams (g)||Standard Error|Least Squares Mean
1446931|NCT00877604|Secondary|Medical Research Council Scores for Right and Left Muscle Groups||1 year|||||||
1445593|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: Left Ventricular Ejection Fraction|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||Percent ejection fraction||Standard Error|Least Squares Mean
1445594|NCT00887588|Secondary|Change From Baseline in Echocardiography Parameters: LVE Diastolic Volume, LVE Systolic Volume, Left Ventricular Stroke Volume, Left Atrial Volume|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ml||Standard Error|Least Squares Mean
1445595|NCT00887588|Secondary|Change From Baseline in Echocardiography (ECHO) Parameters: Left Ventricular End (LVE) Diastolic Diameter, LVE Systolic Diameter, Septal End Diastolic Thickness, Posterior LV Wall End Diastolic Thickness, Relative Wall Thickness, Left Atrial Dimension|A limited two-dimensional and Doppler ECHO examination was done to assess ECHO parameters. A negative change from baseline indicates improvement.|Baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||cm||Standard Error|Least Squares Mean
1445596|NCT00887588|Secondary|Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP)|Evaluation of cGMP was performed by a central laboratory. Change from baseline in cGMP was presented as a ratio where the ratio was calculated as the cGMP value at 36 weeks over the cGMP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio: endpoint/baseline (nmol/L)||95% Confidence Interval|Geometric Mean
1445597|NCT00887588|Secondary|Change From Baseline in NT-proBNP and Brain Natriuretic Peptide (BNP)|Evaluation of NT-proBNP and BNP was performed by a central laboratory. Change from baseline in NT-proBNP and in BNP was presented as a ratio where the ratio for NT-proBNP was calculated as the NT-proBNP value at 36 weeks over the NT-proBNP value at baseline, and the ratio for BNP was calculated as the BNP value at 36 weeks over the BNP value at baseline. A ratio < 1 indicates improvement.|baseline, 36 weeks|Participants from the extension efficacy set, who had both baseline and 36 week values for each parameter, were included in the analysis for that parameter. The extension efficacy set included all randomized participants who had baseline and at least one post-baseline efficacy measurement during the extension period.|||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
1445598|NCT00887588|Primary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|Evaluation of NT-proBNP was performed by a central laboratory. Change from baseline in NT-proBNP was presented as a ratio where the ratio was calculated as the NT-proBNP value at 12 weeks over the NT-proBNP value at baseline. A ratio < 1 indicates improvement.|Baseline, 12 weeks|Participants from the full analysis set (FAS), who had both baseline and 12 week values, were included in the analysis. The FAS consisted of all randomized participants who had baseline and at least one post-baseline efficacy measurement during the double blind period.|||ratio: endpoint/baseline (pg/mL)||95% Confidence Interval|Geometric Mean
1445599|NCT00887575|Secondary|Overall Survival (OS)|Defined as the time between Day 1 Cycle 1 to time of death from any cause.|24 months||||probability of overall survival at 24 m||95% Confidence Interval|Number
1445600|NCT00887575|Secondary|Disease-free Survival|Defined as the time between day of surgery to first documented disease occurrence or death due to any cause.|every 4 weeks from date of surgery until treatment discontinuation or death, expected average 18 months||||months||90% Confidence Interval|Median
1445601|NCT00887575|Secondary|Overall Response Rate (ORR)|Assessed by clinical, radiologic and surgical determinations before and after neoadjuvant therapy. Measurable lesions will be defined by RECIST criteria v1.1.|Days 1, 8 and 15 of each cycle, minimum of 12 weeks|Patients who were enrolled, treated at the MTD and completed at least 3 cycles of neoadjuvant therapy|||participants|||Number
1445602|NCT00887575|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assessments will be made through analysis of reported incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) at the phase II dose|Days 1, 8, and 15 of each 4-week cycle up to 24 weeks during neoadjuvant treatment, and every 4 weeks during maintenance treatment|The safety analysis includes all eligible patients enrolled at the MTD, whether or not treatment was recieved (6 patients in Phase I were treated at the MTD, 39 patients were enrolled in Phase II, 3 were deemed ineligible after enrollment-thus 42 patients are included in the safety analysis, including 1 eligible patient who was not treated)|||participants|||Number
1445603|NCT00887575|Primary|Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin|Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.|at weeks 26-30|Patients treated at Dose Level I (Phase I and Phase II) who underwent surgery|||participants|||Number
1445604|NCT00887562|Secondary|Mean Change in Score on the Fatigue Severity Scale (FSS)|"To assess changes following 1 month treatment with 2 different doses of idebenone with that of placebo in fatigue as assessed by the Fatigue Severity Scale (FSS).~Scale score minimum is 9 (least fatigue) and maximum is 63 (maximum fatigue). Scores of 36 or less indicate possibility that patient may not be suffering from fatigue, while scores 36 and over suggest suffering from fatigue"|Baseline and Week 4||||units on a scale||Standard Deviation|Mean
1445605|NCT00887562|Secondary|Mean Change in Venous Lactate Concentration|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on venous lactate concentration|Up to 4 weeks from baseline||||mM/L||Standard Deviation|Mean
1445606|NCT00887562|Primary|Mean Change in Cerebral Lactate Concentration (as Measured by Magnetic Resonance Spectroscopy)|To compare the efficacy of 1 month treatment with 2 different doses of idebenone with that of placebo on cerebral lactate concentration as measured by magnetic resonance spectroscopy (MRS)|Up to 4 weeks from baseline||||IU||Standard Deviation|Mean
1445607|NCT00887549|Secondary|Percentage of Participants Surviving at 18 Months (Overall Survival Rate)|The percentage of participants surviving at 18 months was defined as the number of treated participants who had not died prior to 18 months from the date of their first dose divided by the total number of treated participants multiplied by 100. For participants who are alive, overall survival was censored at the last contact.|Baseline to date of death (up to 24.5 months)|All enrolled participants. Nineteen participants were censored for overall survival.|||percentage of participants||95% Confidence Interval|Number
1445608|NCT00887549|Secondary|Percentage of Participants With Concordance Between Local and Central Histological Diagnosis|A centralized pathology review on all enrolled participants was performed to confirm the histological diagnosis performed at the site. Upon review of the local diagnosis obtained at the respective site, the central reviewer established whether or not there was an agreement between the local and central diagnosis. The percentage of participants with concordance was defined as the number of participants for which there was an agreement divided by the number of treated participants (concordance rate) multiplied by 100.|Baseline|All enrolled participants.|||percentage of participants||95% Confidence Interval|Number
1445609|NCT00887549|Secondary|Percentage of Participants With Tumor Response (Tumor Response Rate)|Tumor response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Percentage of participants with tumor response was determined by the number of participants with PR or CR (confirmed or not) divided by the total number of treated participants multiplied by 100.|Baseline to disease progression (up to 20 months)|All enrolled participants.|||percentage of participants||95% Confidence Interval|Number
1445610|NCT00887549|Primary|Progression Free Survival (PFS)|PFS is time from first dose to first observation of disease progression/death (any cause). PFS is reported for participants with thymidylate synthase (TS) scores. For participants not known to have died by the data cut-off date and who do not have progressive disease, PFS will be censored at date of last objective progression-free disease assessment. For participants who receive systemic anticancer therapy after study drug discontinuation and prior to disease progression/death, PFS will be censored at date of last objective progression-free disease assessment prior to chemotherapy.|Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy)|Population for the efficacy assessment includes all treated participants with a valid TS expression assessment. Six participants were censored for PFS.|||months||95% Confidence Interval|Median
1445611|NCT00887510|Secondary|Change in Total Adiponectin Level After Addition of Trandolapril to HCTZ Compared With Change in Adiponectin After Addition of HCTZ to Trandolapril|"Comparing the change in adiponectin: rand 1 visit4-visit 3 with rand 2 visit 3-2.~This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril."|Over the course of 18 weeks||||mcg/ml||Standard Deviation|Mean
1445612|NCT00887510|Primary|Change in Oral Glucose Tolerance Test (OGTT) Area Under Curve (AUC) After Addition of Trandolapril to Hydrochlorothiazide (HCTZ) Compared With Change in OGTT AUC After Addition of HCTZ to Trandolapril|Comparing the change in OGTT AUC rand 1 visit4-visit 3 with rand 2 visit 3-2. This allows for understanding the effects of addition of trandolapril to 12 weeks of HCTZ compared with addition of HCTZ to 12 weeks of trandolapril. This is the primary outcome of the study.|OGTT AUC measured over 120 minutes after receiving study intervention for 18-24 weeks.||||minutes*mg/dl||Standard Deviation|Mean
1445613|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445614|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Satisfied; 2, Satisfied; 3, Neutral; 4, Unsatisfied; 5, Very Unsatisfied.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445615|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445616|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Applicable; 1, Very Easy; 2, Easy; 3, Neutral; 4, Difficult; 5, Very Difficult.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445617|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at 8 week timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Week 8|ITT|||Participants|||Number
1445618|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: If you were to choose to continue treatment for your acne, would you use the study product?|Weeks 1 and 2|ITT|||Participants|||Number
1445619|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Week 8|ITT|||Participants|||Number
1445620|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint by answering Yes or No to the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product?|Weeks 1 and 2|ITT|||Participants|||Number
1445621|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at week 8 by answering Yes or No to the following question: Did you use the product every day?. When only one product was applied to the face, subjects were asked to rate their compliance by answering the aforementioned question, rather than rating compliance on a 0-2 scale.|Week 8|ITT|||Participants|||Number
1445622|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, Not Compliant at all; 1, Mostly Compliant; 2, Very Compliant.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445623|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, More Dissatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445624|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Highly Favorable; 2, Favorable; 3, Neutral; 4, Unfavorable; 5, Uncomfortable.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445625|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, More Satisfied; 2, Somewhat More Satisfied; 3, Neither Satisfied or Dissatisfied; 4, Somewhat More Dissatisfied; 5, More Dissatisfied.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445626|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following choices: Epiduo, Clindoxyl Gel, Both Treatments Equally.|Weeks 1 and 2|ITT. Data are presented for only those participants completing the questionnaire.|||Participants|||Number
1445627|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445628|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very Comfortable; 2, Comfortable; 3, Somewhat Comfortable; 4, Somewhat Uncomfortable; 5, Uncomfortable.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445629|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445630|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 1, Very easy; 2, Easy; 3, Neutral; 4, Difficult.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445631|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445632|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe; 5, Very Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445633|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445634|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445635|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445636|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445637|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445638|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445639|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8|Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Week 8|ITT|||Units on a scale||Standard Deviation|Mean
1445640|NCT00887484|Secondary|Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2|Product Acceptability and Preference Questionnaire were completed by the subject at each timepoint using the following scale: 0, None; 1, Very minimal; 2, Mild; 3, Moderate; 4, Severe.|Weeks 1 and 2|ITT|||Units on a scale||Standard Deviation|Mean
1445641|NCT00887484|Secondary|Quality of Life Questionnaire - Global Score|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. A Global Score (range 0-100)=(sum of all 29 individual item scores) * 100/116.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
1445642|NCT00887484|Secondary|Quality of Life Questionnaire - Functional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The functional score (score=0 to 48)=(sum of the 12 individual item scores) * 100/48.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
1445643|NCT00887484|Secondary|Quality of Life Questionnaire - Emotional Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The emotional score (score=0 to 40)=(sum of the 10 individual item scores) * 100/40.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
1445644|NCT00887484|Secondary|Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain|Skindex-29 is a self-administered (by participants at each time point) QoL questionnaire comprised of 29 items (it.) scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 it.); symptomatic (7 it.); functional (12 it.). Domain scores range from 0 to 40, 0 to 28, and 0 to 48, respectively. Lower scores=better QoL. The symptomatic score (score=0 to 28)=(sum of the 7 individual item scores) * 100/28.|Baseline, Weeks 2 and 8|ITT|||Units on a scale||Standard Deviation|Mean
1445645|NCT00887484|Secondary|Non-inflammatory Acne Lesion Counts|Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.|Baseline, Weeks 5 and 8|ITT|||Acne Lesions||Standard Deviation|Mean
1445646|NCT00887484|Secondary|Inflammatory Acne Lesion Counts|Total number of inflammatory acne lesions (pustules, papules) at each timepoint.|Baseline, Weeks 5 and 8|ITT|||Acne Lesions||Standard Deviation|Mean
1445647|NCT00887484|Secondary|Total Acne Lesion Counts|Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),|Baseline, Weeks 5 and 8|ITT|||Acne Lesions||Standard Deviation|Mean
1445648|NCT00887484|Secondary|Investigators Static Global Assessment|ISGA is evaluated using the following scale: 0, Clear: Clear skin with no lesions; 1, Almost Clear: Rare non-inflammatory lesions; 2, Mild: Some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions); 3, Moderate: Up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, Severe: Up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, Very Severe: Many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.|Baseline, Weeks 5, 8|For the first 2 weeks, participants apply one of the drugs (Clindoxyl or Epiduo) to one side of the face and the other drug to the other side of their face. After week 2, participants apply Clindoxyl to their entire face and do not use Epiduo.|||units on a scale||Standard Deviation|Mean
1445649|NCT00887484|Secondary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
1445650|NCT00887484|Secondary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
1445651|NCT00887484|Primary|Irritant/Allergic Contact Dermatitis|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT|||units on a scale||Standard Deviation|Mean
1445652|NCT00887484|Primary|Skin Peeling|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3,Intense."|Weeks 1 and 2|ITT|||units on a scale||Standard Deviation|Mean
1445653|NCT00887484|Primary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|ITT|||units on a scale||Standard Deviation|Mean
1445654|NCT00887484|Secondary|Skin Dryness|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
1446289|NCT00883090|Primary|Terminal Half-life||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||days||Standard Deviation|Mean
1445655|NCT00887484|Secondary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 5 and 8|ITT|||units on a scale||Standard Deviation|Mean
1445656|NCT00887484|Primary|Erythema (Redness)|"Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis)on the face.~Erythema, peeling, dryness, and irritant/allergic contact dermatitis were graded using the following scale: 0, None; 1, Slight; 2, Moderate; 3, Intense."|Weeks 1 and 2|Intent-to-Treat (ITT)|||units on a scale||Standard Deviation|Mean
1445657|NCT00887471|Secondary|Number of Patients With Apnea-hypopnea Index (AHI) Less Than or Equal to 5|Number of patients with postoperative apnea-hypopnea index (apneas plus hypopneas per hour of sleep) less than or equal to 5 on sleep study|Baseline and 4 years||||participants|||Number
1445658|NCT00887471|Primary|Median Change in Apnea-hypopnea Index (AHI)|Change in the number of apneas plus hypopneas per hour of sleep on preoperative sleep study compared to postoperative sleep study, Change is calculated as baseline minus 4-year time point|Baseline and 4 years||||events per hour of sleep||Standard Deviation|Median
1445659|NCT00887458|Secondary|To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.|Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.|Baseline and approximately 2 years from open enrollment|One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression.|||percentage||95% Confidence Interval|Number
1445660|NCT00887458|Primary|To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.|"To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy. PSA progression is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later."|Up to 24 weeks|Based on how many participants were evaluable for the study primary endpoint|||percent of patients||95% Confidence Interval|Number
1445661|NCT00887354|Secondary|"Timed Up and Go Test"|"Timed Up and Go test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley’s pain score."|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||seconds (sec)||Standard Error|Least Squares Mean
1445662|NCT00887354|Secondary|Visual Analog Scale (VAS)|Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.|6, 12, 18, and 26 Weeks|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||millimeter (mm)||Standard Error|Least Squares Mean
1445663|NCT00887354|Secondary|Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale|Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.|Baseline|All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.|||percentage of participants|||Number
1445664|NCT00887354|Secondary|Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire|SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).|Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||units on a scale||Standard Error|Least Squares Mean
1445665|NCT00887354|Secondary|Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb|"Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .~Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use."|Baseline, Week 26; Baseline, Week 52; Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||g/cm^2||Standard Error|Least Squares Mean
1445666|NCT00887354|Secondary|Change in Lumbar Spine Areal Bone Mineral Density|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 26; Baseline, Week 52|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||g/cm^2||Standard Error|Least Squares Mean
1446445|NCT00881504|Secondary|Safety and Toxicity|The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.|8 weeks||||participants|||Number
1445667|NCT00887354|Primary|Change in Lumbar Spine Areal Bone Mineral Density (BMD)|Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).|Baseline, Week 78|All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.|||gram per square centimeter (g/cm^2)||Standard Error|Least Squares Mean
1445668|NCT00887341|Secondary|Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445669|NCT00887341|Secondary|HAQ-DI Score by Visit|HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1445670|NCT00887341|Secondary|Erythrocyte Sedimentation Rate|ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement.|Baseline, Weeks 2, 4, 8, 12,16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1445671|NCT00887341|Secondary|C-Reactive Protein (CRP) Levels|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L).|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||mg/L||Standard Deviation|Mean
1445672|NCT00887341|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)|ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445673|NCT00887341|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)|ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445674|NCT00887341|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)|ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445675|NCT00887341|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)|ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein [CRP])|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445676|NCT00887341|Secondary|DAS28 Score by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value.|Weeks 4, 8, 12, 16, 20, and Final Visit|ITT Population; n (number)=number of participants analyzed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1445677|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT population|||percentage of participants|||Number
1445678|NCT00887341|Secondary|Percentage of Participants Achieving a DAS28 Score <3.2 by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1446932|NCT00877604|Secondary|Incidence and Severity of Adverse Events, and Their Relationship to Treatment|laboratory tests, patients’ reports and the investigator’s judgments|1 year|||||||
1445679|NCT00887341|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference.|Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445680|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab for Any Reason||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445681|NCT00887341|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)||Weeks 4, 8, 12, 16, 20 and Final Visit|ITT Population|||percentage of participants|||Number
1445682|NCT00887341|Primary|Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.|Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
1445683|NCT00887315|Secondary|Overall PFS and CT Rate|Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines|>90 days|The study was terminated before conclusions were reached so no data was analyzed.||||||
1445684|NCT00887315|Primary|1-Year Overall Survival|Overall survival is assessed at 1 year from the date of study enrollment to date of death.|Baseline to death from any cause, 1 year|The study was terminated before conclusions were reached so no data was analyzed.||||||
1445685|NCT00887289|Secondary|Behavioural Changes During Treatment|Number of patients with occurence of behavioural changes in terms of impulse control disorders|Baseline to Visit 3|Full analysis set, no imputation technique was applied|||participants|||Number
1445686|NCT00887289|Secondary|Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3|Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.|Baseline to Visit 3|Full analysis set, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
1445687|NCT00887289|Secondary|Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3|Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.|Baseline to Visit 3|Full analysis set (FAS)|||Scores on scale||Standard Deviation|Mean
1445688|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a neurologist, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
1445689|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|All patients of the full analysis set treated by a general practitioner, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
1445690|NCT00887289|Primary|Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3|Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.|Baseline to Visit 3|Full analysis set, no imputation technique was applied|||Scores on scale||Standard Deviation|Mean
1445691|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (6 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1445692|NCT00887250|Secondary|Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1445693|NCT00887250|Secondary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6|At baseline and at 6 weeks (24 hours post dose)|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1445694|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 12|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
1445695|NCT00887250|Secondary|Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6|Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.|24 hours post dose at Week 6|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
1445696|NCT00887250|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12|At baseline and at 12 weeks (24 hours post dose)|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1445697|NCT00887224|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase|WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.|||scores on a scale||Standard Error|Mean
1445698|NCT00887224|Secondary|Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index|WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
1445699|NCT00887224|Secondary|Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.|Double-blind phase Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).|||participants|||Number
1445700|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase|HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
1445701|NCT00887224|Secondary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
1445702|NCT00887224|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation.|||scores on a scale||Standard Error|Mean
1445703|NCT00887224|Secondary|Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.|Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)|All Randomized population. N=number of participants with analyzable data at observation (Observed Cases).|||participants|||Number
1445728|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Anti-Drug Antibodies||Day 0, 8, 14, 15, 21, 28 and 35|Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.|||Participants|||Count of Participants
1446655|NCT00879775|Secondary|Impact of Symptom Burden to Daily Life (by MD Anderson Symptom Inventory-Korean)|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of impact of symptom burden to daily life.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
1445704|NCT00887224|Primary|Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185|Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).|Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)|All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.|||percent estimated probability|||Number
1445705|NCT00887198|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
1445706|NCT00887198|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
1445707|NCT00887198|Secondary|Maximum Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
1445708|NCT00887198|Secondary|Mean Plasma Concentrations of Abiraterone||Up to Cycle 5, Day 1|Data was not reported as non-compartmental analysis was not performed due to sparse sampling.||||||
1445709|NCT00887198|Secondary|Number of Participants With Treatment Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|From first dose of study drug up to 30 days after the last dose of study drug|Safety analysis set included all participants in the randomized population who received any study drug.|||Participants|||Number
1445710|NCT00887198|Secondary|Time to Prostate-specific Antigen (PSA) Progression|The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.|From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
1445711|NCT00887198|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point|The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
1445712|NCT00887198|Secondary|Time to Initiation of Cytotoxic Chemotherapy|The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
1445713|NCT00887198|Secondary|Time to Opiate Use for Prostate Cancer Pain|The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.|From randomization (Day 1) up to first opiate use or end of study (Month 60)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
1445751|NCT00886795|Secondary|Number of Participants With Clinically Detectable Improvement|Evaluations will occur at each visit after the first infusion. At 3 months, response will be recorded and patients with improvement will be eligible to move into the steroid and/or antihistamine tapering portion of the study. Improvement was determined by a reduction in the number of hives.|at each visit and at 3 months||||participants|||Number
1446933|NCT00877604|Secondary|ALSFRS-R at Study End||1 year|||||||
1446934|NCT00877604|Secondary|Survival Time From Starting of Study Medication Dosing (if Appropriate)||1 year|||||||
1445714|NCT00887198|Primary|Radiographic Progression-free Survival (rPFS)|The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.|From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)|ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
1445715|NCT00887198|Primary|Overall Survival|Overall survival is defined as the time from randomization to date of death from any cause.|From randomization (Day 1) up to end of study (Month 60)|Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
1445716|NCT00887159|Secondary|PFS|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients who had baseline CTC results available for analysis.|||months||95% Confidence Interval|Median
1445717|NCT00887159|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.|||months||95% Confidence Interval|Median
1445718|NCT00887159|Secondary|Response Rate|Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.|||Proportion of patients||95% Confidence Interval|Number
1445719|NCT00887159|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.|Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry|Eligible and treated patients.|||months||95% Confidence Interval|Median
1445720|NCT00886938|Primary|Average Change (Baseline-End of Treatment) Tinnitus Handicap Inventory (THI)|Patient self-reported Tinnitus Handicap Inventory (THI) The mean change (95% CI) in THI scores (Baseline - End of Treatment). Measures tinnitus severity, or how much tinnitus interrupts their life. The THI scores range from 0-100. 0 being no interruption, 100 being severe interruption in their life from tinnitus.|0,4 weeks|Total number of participants completing the full four weeks of treatment, according to protocol.|||units on a scale||95% Confidence Interval|Mean
1445721|NCT00886899|Secondary|Total Procedural Fluoroscopy Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Fluoroscopy time was not available for two participants|||minutes||Standard Deviation|Mean
1445722|NCT00886899|Secondary|Total Procedure Time|Minus any time to determine CTO was refractory to standard guidewire|Intraprocedural|Procedure time data for two participants was not available.|||minutes||Standard Deviation|Mean
1445723|NCT00886899|Primary|30-day Major Adverse Cardiac Event (MACE) Rate|Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.|30 Days|"Includes 21 patients with early (<30 day) follow-up"|||percentage of participants||90% Confidence Interval|Number
1445724|NCT00886899|Primary|Technical Success|Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire|Intraprocedural|Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants.|||percentage of CTOs|Participants|90% Confidence Interval|Number
1445725|NCT00886834|Secondary|Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)|VAS; anchors: 0 =none, 100 mm= worst imaginable|prior to insertion, immediately after insertion, and prior to clinic discharge|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.|||units on a scale||Standard Deviation|Mean
1445726|NCT00886834|Primary|Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)|VAS (anchors: 0 = extremely easy, 100 mm= impossible)|Immediately post IUD insertion|2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.|||units on a scale||Standard Deviation|Mean
1445727|NCT00886821|Other Pre-specified|Stage 2: Number of Participants With Anti-Drug Antibodies||Day 0, 29 and 50|Safety population included all randomized participants who received at least 1 dose of study medication. Here, number analyzed signifies those participants who were evaluable at specified time points.|||Participants|||Count of Participants
1446935|NCT00877604|Secondary|Time to Tracheostomy From Starting of Study Medication Dosing (if Appropriate)||1 year|||||||
1446936|NCT00877604|Secondary|SF-36 Quality of Life Rating Scale||1 year|||||||
1445729|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms|Criteria for abnormal rhythms: asymptomatic marked sinus bradycardia rate <35 bpm; asymptomatic supraventricular couplets, atrial bigeminy lasting >30 seconds; asymptomatic ventricular couplets, ventricular bigeminy lasting >30 seconds; asymptomatic type I second degree (wenckebach) atrioventricular block of >30 seconds duration; asymptomatic frequent premature ventricular complexes (=>200/24 hours); asymptomatic frequent premature atrial complexes (=>240/24 hours).|Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10|Safety population will consist of all randomized patients who received at least 1 dose of study medication.|||Participants|||Count of Participants
1445730|NCT00886821|Other Pre-specified|Stage 1: Number of Participants With Hypoglycemia|Blood glucose level was checked for hypoglycemia by glucometer. Criteria for hypoglycemia: blood glucose level <60 mg/dL if accompanied by symptoms, blood glucose level <=50 mg/dL regardless of symptoms.|Day 1: 0 hour (pre-dose) up to 48 hours post dose|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1445731|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Physical Examinations|Full physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1445732|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Criteria for ECG findings: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >=100 msec, and >=50 percent increase when baseline <=100 msec; QT/QTc interval (corrected QT interval) >=500 msec.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1445733|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Vital Signs|Criteria for vital signs: pulse rate <40 beats per minute (bpm), supine, sitting and erect pulse rate <40 bpm, supine pulse rate >120 bpm, sitting pulse rate >120 bpm, and erect pulse rate >120 bpm; systolic blood pressure: SBP <90 millimeters of mercury (mmHg), change from baseline in SBP greater than or equal to (>=) 30 mmHg; diastolic blood pressure: DBP <50 mmHg, change from baseline in DBP >=20 mmHg.|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1445734|NCT00886821|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).|Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1445735|NCT00886821|Other Pre-specified|Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7|It was assessed by 7-point glucose measurements via the glucose oxidase method.|Baseline, Day 3 and 7|Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data.|||milligram per deciliter(mg/dL)||Standard Deviation|Mean
1445736|NCT00886821|Other Pre-specified|Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7|Area under the glucose concentration-time curve from 0 minute (approximately 20 minutes prior to the meal) to 180 minutes post initiation of meal.|Baseline, Day 3 and 7|Pharmacodynamic analysis population included all randomized participants who had received at least 1 dose of study medication and had PD data. Here, number analyzed signifies those participants who were evaluable at specified time points.|||milligram*hour per deciliter (mg*hr)/dL||Standard Deviation|Mean
1445737|NCT00886821|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50|Safety population included all randomized participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
1445738|NCT00886821|Secondary|Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1|AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1446656|NCT00879775|Secondary|Health-related Quality of Life|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a better health-related quality of life.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
1445739|NCT00886821|Secondary|Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1|Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1445740|NCT00886821|Secondary|Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1|MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||hour||Full Range|Median
1445741|NCT00886821|Secondary|Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
1445742|NCT00886821|Secondary|Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.|||hour||Standard Deviation|Mean
1445743|NCT00886821|Secondary|Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1|Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort (Cohort 9), as pre specified in protocol.|||hour||Standard Deviation|Mean
1445744|NCT00886821|Primary|Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22||pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1445745|NCT00886821|Primary|Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8||pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1445746|NCT00886821|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1||Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1445747|NCT00886821|Primary|Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22||pre-dose, 1 and 6 hours post-dose on Day 22|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||hour||Full Range|Median
1445748|NCT00886821|Primary|Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8||pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. The outcome was not planned to be analyzed for single dosing cohorts (Cohort 1 to 8), since the dosing was done only on Day 1 in these cohorts.|||hour||Full Range|Median
1445749|NCT00886821|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1||Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1|PK analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||hour||Full Range|Median
1445750|NCT00886821|Primary|Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1|AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.|pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1|Pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of PF-04856883 and had PK data. 'N'(Overall number of participants)=participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed in multiple dosing cohort(Cohort 9),as pre-specified in protocol.|||nanogram*hour per milliliter (ng*hr)/mL||Geometric Coefficient of Variation|Geometric Mean
1446937|NCT00877604|Secondary|Forced Vital Capacity (FVC) %||1 year|||||||
1445752|NCT00886795|Primary|Number of Participants With Adverse Events|Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.|baseline, 3 month and 6 months|Participants who received all four doses.|||participants|||Number
1445753|NCT00886769|Secondary|Change in Disability Score Over Time by Use of the CHAQ|The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’(0) to ‘unable to do’ (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.|At 4 week study period|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Units on a Scale||Standard Error|Least Squares Mean
1445754|NCT00886769|Secondary|Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire – Parent Form (CHQ-PF50)|CHQ-PF50 measures HRQoL in children 5-18 years old from parent’s perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.|Over 4 week study period (Baseline, Day 15, Day 29)|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed.|||units on a scale||Standard Error|Least Squares Mean
1445755|NCT00886769|Secondary|Percentage of Patients Who Had Body Temperature ≤ 38°C|Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.|Day 3|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Percent of participants|||Number
1445756|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ|CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’(0) to ‘unable to do’ (3). The parent’s or patient’s pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1445757|NCT00886769|Secondary|Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)|CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from ‘without any difficulty’ (0) to ‘unable to do’ (3). The parent’s or patient’s pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.|Baseline, Day 15|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
1445758|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 100|Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation|baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percent of participants|||Number
1445759|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 90|Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percent of participants|||Number
1445760|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 70|Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percent of participants|||Number
1445811|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number|The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.|2 years|Based on inclusion & exclusion criteria and randomization in a 2:1 ratio to active NF vs. sham NF.|||participants|||Number
1445761|NCT00886769|Secondary|Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria|Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
1445762|NCT00886769|Primary|Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria|Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)|Baseline, Day 15, Day 29|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
1445763|NCT00886743|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oprelvekin|Tmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.|Postdose Day 1 to end of treatment|All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.|||hours|||Number
1445764|NCT00886743|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Oprelvekin|Cmax was obtained directly from the serum oprelvekin concentration data using noncompartmental methods.|Postdose Day 1 to end of treatment|All participants who received at least 1 dose of study drug and had at least 1 concentration assessment.|||picograms/mililiter|||Number
1445765|NCT00886743|Secondary|Number of Participants With Corrected QT (QTc) Interval ≥450, ≥480, and ≥500 Msec Using Bazett's (QTcB) and Fridericia's (QTcF) Correction Formulas|Definition of QTc is based on observed individual values rather than the average across triplicate starting from Day 1 postdose through the end of treatment.|Postdose Day 1 to end of treatment|Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.|||Participants|||Number
1445766|NCT00886743|Secondary|Number of Participants With Time-matched Change From Baseline in Corrected QT (QTc) Interval ≥30 or 60 Msec Using Fridericia's (QTcF) and Bazett's (QTcB) Correction Formulas|Based on average across triplicates for a given hourly measurement.|Postdose Day 1 to end of treatment|Participants who completed baseline and postdose triplicate electrocardiograms through at least 3 continuous days of dosing. Those who received any systemic concomitant medications that had the potential for drug interaction and sporadic effect on QT/QTc data, and thus impacted results, were excluded from the analyses.|||Participants|||Number
1445767|NCT00886743|Primary|Time-matched Change From Baseline in Corrected QT Interval Using a Population-specific Correction Formula (QTcN)|Because the sponsor terminated the study prematurely, this population-specific correction of QT was not done. QT data collected during the study corrected using the Bazett’s and Fridericia formulae are presented as secondary outcome measures.|Postdose Day 1 to end of treatment|||||||
1445768|NCT00886704|Primary|Omega-3 Index|Percentage of eicosapentaenoic and docosahexaenoic acids in total red cell fatty acids, as determined with a standardized analytical procedure, i.e. the HS-Omega-3 Index. Currently, the target range for the HS-Omega-3 Index has been suggested to be between 8% and 11%. Cardiovascular risk increases at levels below 8%, whereas levels above 11% do not seem to confer further benefit. Values of the HS-Omega-3 Index have been found between 1.5% and 20%.|after eight weeks of intervention||||% EPA+DHA in total red cell fatty acids||Standard Deviation|Median
1445769|NCT00886704|Secondary|Palatability|Palatability assessed as number on a visual analogue scale from 0 - 10, with 0 being the worst and 10 being the best possible outcome|at 8 weeks|Per protocol analysis|||Number on a scale from 0 - 10||Standard Deviation|Mean
1445770|NCT00886691|Secondary|Percentage of Participants With at Least One Cancer Antigen 125 (CA-125) Response|Response as evaluated by CA-125 levels.A CA 125 test measures the amount of the protein CA 125 (cancer antigen 125) in blood.CA 125 is a tumor marker recommended for clinical use in the diagnosis and management of ovarian cancer. CA-125 responses were assessed with Rustin criteria. Initial values had to be 2x ULN (upper limit of normal) within 2 weeks of starting therapy to be considered evaluable.Patient were evaluated by using best overall response while receiving study therapy.|Prior to each cycle of treatment. Then follow-up every three months for 2 years , then 6 months for 3 years for 5 years follow up.|CA-125 evaluable patients|||percentage of participants||90% Confidence Interval|Number
1445771|NCT00886691|Secondary|The Proportion of Patients With Measurable Disease Who Have Objective Tumor Responses by Treatment.|Complete and Partial Tumor Response by RECIST 1.0|Up to 5 years|All measurable patients treated on Everolimus plus Bevicizumab and Placebo plus Bevacizumab.|||percentage of participants responding||95% Confidence Interval|Number
1445772|NCT00886691|Secondary|Characterize and Compare Progression-free Survival and Overall Survival in Patients With Measurable Disease (RECIST Criteria) and Patients With Detectable (Non-measurable) Disease|Progression-free survival and overall survival broken down by measurable disease status|Continued until disease progression was assessed or up to 5 years in follow-up.|All Intent to treat patients|||Months||95% Confidence Interval|Median
1445773|NCT00886691|Secondary|Incidence of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)|Number of participants with a grade of 3 or higher during the treatment period.|All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment|All Intent to treat patients.|||Participants|||Count of Participants
1445812|NCT00886340|Secondary|Quality of Life||6 months|||||||
1445813|NCT00886340|Secondary|Lipids||6 months|||||||
1445774|NCT00886691|Primary|Progression-free Survival|The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as an 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Duration of time from start of treatment to time of progression, assessed up to 5 years|All intent to treat patients|||months||95% Confidence Interval|Median
1445775|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 22: minute 0 and 6|||||||
1445776|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 21: minute 0 and 6|||||||
1445777|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 2: minute 0 and 6|||||||
1445778|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 2: minute 0 and 6"|||||||
1445779|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 20: minute 0 and minute 6|||||||
1445780|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 21: minute 0 and minute 6|||||||
1445781|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 22: minute 0 and minute 6|||||||
1445782|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 2: minute 0 and minute 6|||||||
1445783|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|day 21: minute 0 and minute 6|||||||
1445784|NCT00886639|Secondary|Oxygen Saturation|Change of oxygen saturation from minute 0 to 6 in 6Minute-walking test on oxygen/ medical air|day 1: minute 0 and 6|||||||
1445785|NCT00886639|Secondary|BORG-Score|change of BORG-Score from pre to post 6 minute-walking test (minute 0 and 6)on oxygen/ medical air|day 1: minute 0 and minute 6|||||||
1445786|NCT00886639|Secondary|Lung Function|change in lung function from baseline to 3 weeks|day 1 and 21|||||||
1445787|NCT00886639|Secondary|Diffusion Capacity|change in diffusion capacity from baseline to 3 weeks|day 1 and 21|||||||
1445788|NCT00886639|Secondary|Oxygen Partial Pressure (paO2)|change in paO2 from minute 0 to minute 6 in 6-minute-walking test on oxygen/ medical air|"day 1: minute 0 and 6"|||||||
1445789|NCT00886639|Primary|Oxygen Response|Change in oxygen response (6-minute-walking distance on oxygen minus 6-minute-walking distance on medical air) from baseline to 3 weeks|day 1 and day 2; day 21 and day 22|per protocol|||Meter||Standard Deviation|Mean
1445790|NCT00886626|Primary|Change in Body Mass Index (BMI)|Change in body mass index (BMI) over three months|3-month|Data from all participants who completed the trial were analyzed.|||change in kg/m^2||Standard Deviation|Mean
1445791|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Injection Site Adverse Events Post Administration of VZV Skin Tests (Part B)|The number of participants with injection site adverse events due to the VZV skin test after administration of the VZV skin test antigen.|1-5 days post administration of each VZV skin test|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.|||Participants|||Number
1445792|NCT00886613|Primary|Number of Healthy, Elderly, Immunocompetent Participants With a Positive VZV Skin Test After Administration of 2 Doses of V212 Vaccine (Part B)|"Number of participants with a positive VZV skin test after 2 vaccine doses was determined. Participants with a negative VZV skin test reaction at baseline were evaluated for VZV immunogenicity by a final VZV skin test administered 14 days after dose 2 of vaccination.~For the VZV skin test participants were injected intradermally with the VZV skin test reagent, and reaction to the skin test was assessed after 48-72 hrs. A skin reaction (erythema and induration) around the injection site measuring >= 5mm for the VZV antigen was considered a positive skin test."|48-72 hours after administration of skin test at 14-17 days postdose 2|Per protocol population - participants with a negative baseline VZV Skin Test (<5 mm skin reaction to both, saline and the VZV skin test reagent), and who did not have a protocol deviation that could interfere with the immune response to vaccine following two administrations of either ZOSTAVAX™, placebo, or V212|||Participants|||Number
1445793|NCT00886613|Secondary|Number of Healthy Elderly Men and Women With Adverse Events Post Vaccination With V212 (Part B)|The number of participants with all serious and nonserious adverse events, and vaccine-related serious and nonserious adverse events, from 1-28 days post any vaccination dose was determined to assess safety. Non serious adverse events include injection-site adverse events as well as systemic adverse events post vaccination. Vaccine-related events include all events that were possibly, probably or definitely related to the vaccine according to the investigator. Participants with injection site adverse events due to administration of VZV skin tests are not included.|1-28 days post vaccination dose 1 and 1-28 days post vaccination dose 2|Participants from Part B. One participant in the placebo group was not vaccinated and is not included in the analysis.|||Participants|||Number
1445794|NCT00886613|Secondary|VZV Skin Test Reactions at 48 and 72 Hours (Part A)|Prior to vaccination, participants were administered a baseline VZV skin test for which the skin test reagent and saline were injected in opposite arms. The skin reaction (erythema and induration) around the injection site was assessed at 48 hours and at 72 hours. The reaction was marked with a ball point pen and the longest dimension closest to 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were defined as having a negative baseline skin test; and a measure of >= 5mm for the VZV antigen were defined as having a positive skin test.|48 hours and 72 hours post administration of baseline skin test|42 participants enrolled in Part A|||Participants|||Number
1445810|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #2. Retention|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).|40th treatment sessions ~ 13-20 weeks|Number randomized was denominator for percentage of participants completing 40 treatment sessions.|||percentage of participants|||Number
1445795|NCT00886613|Primary|Number of Participants With a Negative VZV Skin Test at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms, and assessed for a skin reaction around the injection site. The skin reaction assessed was erythema (redness of skin) and induration (palpable, raised, hardened area) around the injection site, which was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline and < 5mm for the VZV antigen were considered to have a negative baseline skin test.|48 hours following administration of the baseline skin test|Participants enrolled in Part A with a negative reaction for saline.|||Participants|||Number
1445796|NCT00886613|Other Pre-specified|Number of Participants With a Negative Reaction for Saline at Baseline (Part A)|Participants were given the VZV skin test prior to vaccination. For the baseline VZV skin test, they were administered VZV skin test reagent and saline in opposite arms. The skin reaction (erythema and induration) to saline was marked with a ball point pen. The longest dimension to the closest 1 mm was measured. Participants with a reaction measure < 5mm for saline had a negative reaction for saline, and measure >= 5mm for saline had a positive reaction for saline at baseline.|48 hours following administration of the baseline skin test|42 participants enrolled in Part A|||Participants|||Number
1445797|NCT00886600|Secondary|Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
1445798|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6||Baseline and 24-hours after morning dose at Week 6|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
1445799|NCT00886600|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4||Baseline and 24-hours after morning dose at Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
1445800|NCT00886600|Primary|Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24-hour period at baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
1445801|NCT00886600|Primary|Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4||24 hour period at Baseline and Week 4|"The efficacy analysis followed a per protocol approach in that only patients who completed the study according to the protocol were included in the analysis."|||mm Hg||Standard Deviation|Mean
1445802|NCT00886587|Secondary|Itch Score on Day 43 - Change From Baseline|The subject’s and/or caregiver's assessment of itch was measured on a 10-cm visual analog scale (VAS) in which 0 cm represented no itch and 10 cm represented worst itch imaginable.|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
1445803|NCT00886587|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 43 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA), with possible values of clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5).|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
1445804|NCT00886587|Secondary|Eczema Area and Severity Index (EASI) on Day 15 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).|Baseline to Day 15|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
1445805|NCT00886587|Primary|Eczema Area and Severity Index (EASI) Score on Day 43 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final possible calculation ranging from 0 (none) - 72 (severe).|Baseline to Day 43|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
1445806|NCT00886483|Primary|Necessary Duration of Treatment|The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.|40 treatment sessions ~ 13-20 weeks|Number of participants in active (n=24) and sham (n=10) neurofeedback completing 40 treatments.|||units on a scale||Standard Deviation|Mean
1445807|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice|Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.|24 treatments ~ 8-12 weeks|participants completing treatment 24|||percentage of participants|||Number
1445808|NCT00886483|Primary|Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction|Parent & child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).|24 treatments ~ 8-12 weeks|Those completing 24 treatments|||units on a scale||Standard Deviation|Mean
1445809|NCT00886483|Primary|Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind|The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.|Post-treatment at session 40|Participants in both Active and Sham Neurofeedback completing 40 treatment sessions.|||percentage of participants|||Number
1445814|NCT00886340|Secondary|Diet and Exercise Behavior||6 months|||||||
1445816|NCT00886288|Secondary|Percentage of Patients With Positive to Negative Shift in Albuminuria|Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks|Approximately 12 weeks (10 to 14 weeks) after baseline|All patients with albuminuria at initial visit and for which information on albuminuria was known at visit 2, 12 weeks after the initial visit.|||Percentage of patients||95% Confidence Interval|Number
1445817|NCT00886288|Secondary|Percentage of Patients Presenting an Adverse Event (AE)|Percentage of patients with any adverse events during the study period, related or not to investigational drug|baseline to the end of study period|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||percentage of patients|||Number
1445818|NCT00886288|Secondary|Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)|The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) – SBP (12 weeks) ≥ 10 mmHg|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||Percentage of patients|||Number
1445819|NCT00886288|Secondary|Mean Difference in Diastolic Blood Pressure|The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) – DBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||mmHg||Standard Deviation|Mean
1445820|NCT00886288|Secondary|Mean Difference in Systolic Blood Pressure|The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) – SBP (12 weeks) expressed in mmHg|baseline and approximately 12 weeks|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||mmHg||Standard Deviation|Mean
1445821|NCT00886288|Primary|Percentage of Patients With Controlled Blood Pressure|"Systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg if the patient has:~no chronic renal insufficiency or macroalbuminuria-dipsticks negative,~albuminuria is < 300 mg/24h or < 200 mg albumin per gram of creatinine~no diabetes~or SBP < 130 mmHg and DBP < 80 mmHg if the patient has:~chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine~diabetes (type 1 or 2)"|approximately 12 weeks (10 to 14 weeks) after baseline|1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)|||Percentage of patients|||Number
1445822|NCT00886145|Primary|Percent Change From Baseline in Volumetric Bone Mineral Density (vBMD) at 6-Months|Volumetric Bone Mineral Density of the Right and Left Distal Tibia as Determined by Peripheral Quantitative Computed Tomography|The Percent Change in vBMD from Baseline to 6 months after Mechanical Stimulation Vibration Therapy||||Percent Change|||Number
1445823|NCT00886119|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per Protocol. Analysis excluded major protocol deviations as determined by masked review.|||logMAR||Standard Deviation|Mean
1445824|NCT00886015|Secondary|Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis|"Trichiasis is generally defined as 1 or more eyelashes touching globe in primary position. Classifications of trichiasis severity are as follows:~Mild: 1-4 Eyelashes touching globe, no epilation OR 1-10 Eyelashes epilated, no eyelashes touching globe; Moderate: 5-9 Eyelashes touching globe, no epilation OR 1-4 Eyelashes touching globe and 1-10 eyelashes epilated; Severe: 5-9 Eyelashes touching globe and 1-10 eyelashes epilated OR 10 Eyelashes touching globe, regardless of epilation status OR 11-20 Eyelashes epilated, regardless of eyelashes touching globe OR Entire eyelid epilated, regardless of eyelashes touching globe"|2 Years|Of the 1669 TT eyelids and 1674 BLTR eyelids included in the initial analysis, 13 eyes (4 in the TT clamp group, 9 in the BLTR group) without TT at 1 year underwent operation between years 1 and 2. They are not included in the data for severity of recurrence because we do not know the TT severity.|||eyelids|eyelids||Number
1445825|NCT00886015|Secondary|Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality|"Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. ECA severity is defined as follows:~Mild: Vertical deviation from the natural contour < 1 mm in height (less than half the pupil height in daylight) and affecting < 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1–2 mm in height (about the pupil height in daylight) or affecting 1/3–2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour > 2 mm in height (more than the pupil height in daylight) or a defect > 2/3 of the horizontal eyelid length"|2 years|Of the 1771 participants originally assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
1445826|NCT00886015|Primary|Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities|"Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows:~Mild: Vertical deviation from the natural contour < 1 mm in height (less than half the pupil height in daylight) and affecting < 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1–2 mm in height (about the pupil height in daylight) or affecting 1/3–2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour > 2 mm in height (more than the pupil height in daylight) or a defect > 2/3 of the horizontal eyelid length"|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
1445827|NCT00886015|Primary|Number of Eyelids Experiencing an Unfavorable Outcome|At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
1446657|NCT00879775|Secondary|Degree of Fatigue at the Point of Time With Numeric Rating Scale From 0 to 10|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; a higher score represents a higher level of fatigue.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
1445828|NCT00886015|Primary|Number of Eyelids With Pyogenic Granuloma|A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.|2 years|Of the original 1771 eyelids assigned to TT clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up|||eyelids|eyelids||Number
1445829|NCT00886015|Primary|Number of Eyelids With Presence of Recurrent Trichiasis|Trichiasis: 1 or more eyelashes touching globe in primary position|2 years|Of the 1671 eyes initially assigned to TT Clamp, 1 participant (2 eyelids) was excluded from TT Clamp analysis because participant died before follow-up.|||eyelids|eyelids||Number
1445830|NCT00885846|Primary|Fasting Blood Glucose||Week 0 (baseline) and week 12 (final)|Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.|||mg/dL||Standard Deviation|Mean
1445831|NCT00885846|Secondary|Fasting Cortisol||Weeks 0 and 12|||||||
1445832|NCT00885846|Secondary|HOMA-IR Index||weeks 0 and 12|||||||
1445833|NCT00885846|Secondary|Beck's Depression Inventory (BDI)||weeks 0 and 12|||||||
1445834|NCT00885846|Secondary|Perceived Stress Scale (PSS)||weeks 0 and 12|||||||
1445835|NCT00885846|Secondary|Fasting Insulin||weeks 0 and 12|||||||
1445836|NCT00885846|Secondary|Fasting C-peptide||weeks 0 and 12|||||||
1445837|NCT00885768|Primary|The Number of Patients With Renal Artery Stenosis|the prevalence of renal artery stenosis in patients with coronary artery disease|3months||||participants|||Number
1445838|NCT00885768|Primary|Prevalence of Renal Artery Stenosis (RAS)||2 months|||||||
1445839|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Response by Best Overall Response by CR, PR, SD or PD in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.|||percentage of participants|||Number
1445840|NCT00885755|Primary|Part II: Percentage of Participants With a Best Overall Response of CR, PR, SD or PD by Biomarker|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm.PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (<median/≥median) , PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.|||percentage of participants|||Number
1445841|NCT00885755|Primary|Part I: Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progrerssive Disease (PD) by Biomarker|BOR was defined according to the Response Evaluation Criteria In Solid Tumors (RECIST). CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions. The relationship between best response and the following biomarkers was investigated: p95 HER2 (+ve/-ve), IGF1R, c-MET, PTEN, HER2 (median/≥median), PI3K catalytic subunit (WT/M), and FC gamma receptors IIIa, IIa and IIb (phenotypes FF, VF, VV, HH, HR, RR and II, IT and TT respectively). The correlation between the biomarker variables and percentage of participants with best response were investigated using a univariate regression analysis.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker. Data are reported for Group A only as there were no evaluable participants in Group B.|||percentage of participants|||Number
1445842|NCT00885755|Primary|Part II: TTP by Biomarker|TTP was calculated from first study medication in Part II to date of progression. The relationship between TTP and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT .|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
1445865|NCT00885703|Secondary|Length of Hospitalization|Duration of first hospitalization in days starting at entry in safety population.|Measured from study entry through Week 10|Arms pooled by dose in safety population (see study detailed description for details). Fluconazole 2000mg arm had one participant data missing (was not admitted to hospital at study entry).|||Days||Inter-Quartile Range|Median
1445890|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.|||mm Hg||Standard Error|Mean
1445843|NCT00885755|Secondary|Part I and II: Percentage of Participants With a Best Overall Response of CR or PR in ITT Population|Best Overall response was defined according to RECIST. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; n = number of participants analyzed for the specified category.|||percentage of participants|||Number
1445844|NCT00885755|Secondary|Overall Survival in ITT Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|ITT population|||months||Full Range|Median
1445845|NCT00885755|Secondary|Overall Survival in Per Protocol Population|Overall survival was calculated in months from the day of screening until death.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until death (up to 46 months)|PP population|||months||Full Range|Median
1445846|NCT00885755|Secondary|Part II: PFS in ITT Population|PFS was calculated from first study medication in Part II to date of progression or death. In participants with measurable disease progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
1445847|NCT00885755|Secondary|Part II: TTP in Intent to Treat (ITT) Population|TTP was calculated from first study medication in Part II to date of progression. In participants with measurable disease progression was defined according to RECIST(SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
1445848|NCT00885755|Secondary|Part I: PFS in ITT Population|PFS was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]).. In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
1445849|NCT00885755|Primary|Part I: Time to Progression (TTP) by Biomarker|Progression was defined as an increase by at least 20% from the smallest value in the SLD of lesions.TTP was determined as the time in months from the date of screening until first progression.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95 HER2 +ve and -ve population, IGF1R <median and ≥median, c-MET <median and ≥median, PTEN <median and ≥median, HER2 <median and ≥median, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT . The correlation between the biomarker variables and TTP were investigated using a univariate Cox regression model and time-to-event methods (Kaplan-Meier).|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 weeks|PP population; n = number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
1445850|NCT00885755|Primary|Part II: Progression Free Survival (PFS) by Biomarker|PFS was calculated from first study medication in Part II to date of progression or death.The relationship between PFS and the following biomarker variables was investigated in each of study Part 1 and 2: p95HER2 +ve and -ve population, IGF1R <median and ≥ median membrane H score, c-MET <median and ≥median membrane H score, PTEN <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, PI3K catalytic subunit WT and M, and FC gamma receptors IIIa, IIa and IIb Phenotypes FF, VF and VV, HH, HR and RR, and II, IT and TT.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|PP population; n = number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
1445851|NCT00885755|Secondary|Part I: TTP in Intent to Treat (ITT) Population|TTP was determined as the time in months from the date of screening until first progression. In participants with measurable disease, progression was defined according to RECIST (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]). In participants with non-measurable disease, progression was defined as the presence of new lesions or unequivocal progression during treatment.|End of first 2 Cycles (Weeks 3 and 6), every 3 cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|ITT population; Participant from Group B and from No group were not included in this analysis.|||months||95% Confidence Interval|Median
1445866|NCT00885703|Secondary|Results of Functional Status Evaluation|"Functional assessment of work status and ability. Consists of 2 measures: 1) Does participants have full time work status 2) Does participant have functional ability to work.~The measure from 6 week before enrollment will be referred to as 'baseline'."|Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24|Arms pooled by dose. Safety population (see study detailed description for details).|||Participants|||Count of Participants
1445852|NCT00885755|Primary|Part I: Progression Free Survival (PFS) by Biomarker|Progression was defined as an increase by at least 20 percent (%) from the smallest value in the Sum of Longest Diameter (SLD) of lesions. Biomarkers investigated: p95 human epidermal growth factor receptor 2 (p95HER2) positive (+ve) and negative (-ve) , insulin growth factor-1 receptor (IGF1R) less than (<) median and greater than or equal to (≥) median membrane H score, c-MET <median and ≥median membrane H score, phosphatase and tensin homolog gene (PTEN) <median and ≥median cytoplasm H score, HER2 <median and ≥median membrane H score, phosphatidylinositol-3-kinase (PI3K) catalytic subunit wild type (WT) and mutation (M), and FC gamma receptors IIIa homozygous Phenyl alanine (FF), heterozygous Phenyl alanine/Valine (VF) and homozygous Valine (VV), receptor IIa Phenotypes homozygous Histidine (HH), heterozygous Histidine/Arginine (HR) and homozygous Arginine (RR) IIb phenotypes homozygous Isoleucien (II),heterozygous Isoleucine/Threonine (IT) and homozygous Threonine (TT) .|End of first 2 Cycles (Weeks 3 and 6), every 3 Cycles for 18 weeks, then every 4 cycles until progression, unacceptable toxicity or participant decision to cease treatment up to 46 months|Per Protocol (PP) population included all participants who had received a complete first dose of study medication and had baseline and at least one on-treatment biomarker assessment. Number (n) equals (=) number of participants with biomarker data available for the specified biomarker.|||months||95% Confidence Interval|Median
1445853|NCT00885742|Secondary|Achievement of Trough Factor XIII Levels of 5% or Higher.|Number of subjects with Factor XIII level ≥ 5% before infusion at Week 12, Week 24, Week 36 and Week 48.|At 12, 24, 36 and 48 weeks: immediately before infusion.|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.|||participants|||Number
1445854|NCT00885742|Secondary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of (U/kg) infusion.|At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Units/mL/Units/kg||Standard Deviation|Mean
1445855|NCT00885742|Secondary|Time to Peak Concentration||At 12, 24, 36 and 48 weeks: immediately before infusion, then at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Hour||Standard Deviation|Mean
1445856|NCT00885742|Secondary|Trough FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: immediately before infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Units/mL||Standard Deviation|Mean
1445857|NCT00885742|Secondary|Peak FXIII Concentration at Steady State||At 12, 24, 36 and 48 weeks: at 30 and 60 minutes after the end of the infusion.|The Pharmacokinetic (PK) Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters).|||Units/mL||Standard Deviation|Mean
1445858|NCT00885742|Secondary|Adverse Events|Number of subjects with any treatment-emergent adverse event (AE), treatment-related AE or serious AE (SAE). Treatment related AEs are defined as AEs whose relationship to study treatment is related, or possibly related, and AEs with missing relationship.|12 months|The Safety Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study.|||participants|||Number
1445859|NCT00885742|Secondary|Association of the Incidence of Spontaneous Bleeding Events Requiring Treatment and FXIII Activity Trough Levels|P-value determined from Generalized Estimating Equation (GEE) model parameter estimates with bleeding as the response variable and FXIII activity trough level as the explanatory variable.|12 months|The analysis population comprised those subjects with spontaneous bleeding events requiring treatment with a FXIII-containing product. Note: no subjects had spontaneous bleeding events requiring treatment with a FXIII-containing product, so no subjects were analyzed.|||participants|||Number
1445860|NCT00885742|Primary|The Incidence of Spontaneous Bleeding Events Requiring Treatment (Treatment is Defined as Administration of a FXIII‑Containing Product to Treat the Bleeding Event)|The number of subjects requiring treatment with a Factor XIII-containing product to treat a spontaneous bleeding event.|Up to week 52|The Efficacy Population comprised all subjects who received a dose of FXIII Concentrate (Human) during the study and included those who were assessed for efficacy at Baseline and had at least 1 follow-up FXIII activity trough level.|||participants|||Number
1445861|NCT00885703|Secondary|Number of Participants With Grade 3 and 4 Adverse Events|"Occurrence of grade 3 (severe) and 4 (life-threatening) sign and symptoms events (as defined by FSTRF Appendix 29)~Occurrence of grade 3 (severe) and 4 (life-threatening) laboratory events (as defined by FSTRF Appendix 76)~See DAIDS AE Grading table V1.0"|Measured from study entry through Week 24|Arms pooled by dose in safety population (see study detailed description for details).|||Participants|||Count of Participants
1445862|NCT00885703|Secondary|Number of Participants With CNS IRIS|Number of participants who were diagnosed with CNS immune reconstitution inflammatory syndrome (IRIS)|Measured from study entry through Week 24|Arms pooled by dose in study population (see study detailed description for details).|||Participants|||Count of Participants
1445863|NCT00885703|Secondary|Number of Participants With Progression of Symptoms|"Progression of symptoms is defined as:~Died (including early deaths)~Discontinued Fluconazole and started ampho B~Had a positive cryptococcal culture at week 10~Microbiological Failure (i.e., relapse of CM)~Complication of CM (e.g., obstructive hydrocephalus or vascular complications such as venous or arterial thrombosis)~CM IRIS causing increased inflammation after ART exposure~New CNS Ol (e.g., toxoplasmosis, PML, CNS lymphoma)~Possibly related to CM but mechanism indeterminate~Other defined complication unrelated to CM"|Measured from study entry through Week 24|Arms pooled by dose. Analysis done in efficacy population (see detailed study description for details).|||Participants|||Count of Participants
1445867|NCT00885703|Secondary|Results of the Neurological Examination|Results from Glasgow Coma Score, which provides assessment of impairment of conscious level in response to defined stimuli. Min score of 0 and max score of 15 (no mental impairment).|Measured at study entry, Week 2, and Week 10|Arms pooled by dose. Safety population (see study detailed description for details).|||Participants|||Count of Participants
1445868|NCT00885703|Primary|Kaplan Meier (KM) Proportion of Participant Mortality|Kaplan Meier Proportion of participants who died over study with 90% Confidence Intervals.|Measured from study entry through Week 24|Arms pooled by dose in the safety population (see study detailed description for details).|||proportion of participants||90% Confidence Interval|Number
1445869|NCT00885703|Primary|Change in Log10 Quantitative CSF Culture Results|"Change in quantitative CSF (cerebrospinal fluid) cultures.~Note: No further CSF specimens are drawn following a negative culture. Thus, only week 2 CSF cultures are considered in this analysis."|Entry and Week 2|Arms pooled by dose. Analysis done in efficacy population (see study detailed description for details). Excludes participants who did not have a week 2 observation.|||Log10 CFU/mL||Inter-Quartile Range|Median
1445870|NCT00885703|Primary|Categorized Quantitative Culture Results|Count of participants who were CM negative (had no cryptococcal growth), CM negative after switching treatment (switched from Fluconazole to Ampho B or vice versa and later became CM negative), CM positive, Died, Lost to follow-up. Note: CM positive means continued to have cryptococcal growth.|At entry, Week 2, and Week 10|Arms pooled by dose. Analysis in efficacy population (see study detailed description for details).|||Participants|||Count of Participants
1445871|NCT00885703|Primary|Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B|"Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2~Discontinuation includes discontinuing for any reason, including progression of symptoms, death, etc."|Measured from study entry through Week10|Analysis in safety population (see study detailed description for details)|||Participants|||Count of Participants
1445872|NCT00885677|Primary|Phase 2: Combined Endpoint of Death From Any Cause, Cardiovascular and Device-related Hospitalizations (at Least 48 Hours Stay), Calculated as Number of Subjects With at Least One Event|Time to first event|2 years after randomization|All subjects in analysis were included in the primary endpoint analysis|||participants|||Number
1445873|NCT00885677|Primary|Phase 1: Median Time Between Event Onset Time and Clinical Decision for Each Subject.|The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group|1 year since the randomization|Phase 1: A total of 154 patients were enrolled from May 2009 through April 2010 from 32 centers in 6 different countries (France, Hungary, Israel, Italy, Spain, and Switzerland). The final patient cohort object of analysis comprised 148 patients (76 in the Remote group and 72 in the Control group)|||days||Inter-Quartile Range|Median
1445874|NCT00885638|Secondary|Insulin Secretion After Ingestion of Meal|Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion|300 min|Completer population|||mol/l/min||Standard Error|Mean
1445875|NCT00885638|Primary|Glucagon-like Peptide-1 Secretion After Meal Ingestion|Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion|300 min|Completer population|||nmol/l/min||Standard Error|Mean
1445876|NCT00885534|Primary|Overall Response to CVT Chemotherapy.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 years||||participants|||Number
1445877|NCT00885482|Secondary|Change of Bone Density and of Subcutaneous Fat at 48 Weeks||48 weeks|||||||
1445878|NCT00885482|Secondary|Change of the Results of Neurocognitive Tests at 48 Weeks||48 weeks|||||||
1445879|NCT00885482|Secondary|Change of Metabolic Parameters at 48 Weeks||48 weeks|||||||
1445880|NCT00885482|Secondary|Evolution of Atazanavir Plasma Concentrations During the 48 Weeks||48 weeks|||||||
1445881|NCT00885482|Secondary|Evolution of Adherence and Quality of Life During the 48 Weeks||48 weeks|||||||
1445882|NCT00885482|Secondary|Evolution of CD4 Cell Count During the 48 Weeks||48 weeks|||||||
1445883|NCT00885482|Secondary|Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis||48 weeks|||||||
1445884|NCT00885482|Secondary|Time to Virological Failure at Survival Analysis||48 weeks|||||||
1445885|NCT00885482|Primary|Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis||48 weeks||||patients|||Number
1445886|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria|Marked abnormality criteria were urine protein: if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine blood: if pre-Rx=0, use >=2, if pre-Rx=0.5 or 1, use >=3, if pre-Rx=2, use >=4; Urine red blood cell count (RBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine white blood cell count (WBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4.|Baseline, Week 12|All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.|||Participants|||Number
1445887|NCT00885378|Other Pre-specified|Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria|A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. ULN=upper limit of normal; LLN=lower limit of normal.|Baseline, Week 12|All treated participants.|||Participants|||Number
1445888|NCT00885378|Primary|Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with both a baseline value and post-baseline value (up to Week 12).|||Percentage of glycosylated hemoglobins||Standard Error|Mean
1445889|NCT00885378|Other Pre-specified|Baseline and Mean Change From Baseline in Participant Heart Rate (HR)|Baseline values reference the measurement for the cohort of participants evaluated at the given time point.|Baseline, Week 4, Week 8, Week 12|All treated participants. n= number of participants with measurement at time point.|||mm Hg||Standard Error|Mean
1445891|NCT00885378|Other Pre-specified|Participant Electrocardiogram (ECG) Status at Baseline and Week 12|Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.|Baseline, Week 12|All treated participants, excluding those with missing values.|||Participants|||Number
1445892|NCT00885378|Other Pre-specified|Participants With Confirmed Hypoglycemia|Confirmed hypoglycemia was defined by a fingerstick glucose value <= 50 mg/dL with associated hypoglycemia symptoms.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.|||Participants|||Number
1445893|NCT00885378|Other Pre-specified|Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period|Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.|||Participants|||Number
1445894|NCT00885378|Other Pre-specified|Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary|AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment.SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug.|Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period.|All treated participants.|||Participants|||Number
1445895|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.|||Percentage of Participants||95% Confidence Interval|Number
1445896|NCT00885378|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12|Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)|Week 12|Randomized participants with measurement at timepoint with LOCF.|||Percentage of Participants||95% Confidence Interval|Number
1445897|NCT00885378|Secondary|Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change was adjusted for baseline.|Baseline, Week 12|Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).|||mg / dL||Standard Error|Mean
1445898|NCT00885365|Secondary|Participants With a Hearing Threshold >20 Decibel in at Least One Ear|The potential ototoxic effects (hearing loss) of tobramycin were investigated by performing audiometric tests. Participants with a loss of auditory acuity greater than the 20 decibels auditory threshold are reported.|Day -10 to -1 (screening), Weeks 4 and 8|Safety population|||percentage of participants|||Number
1445899|NCT00885365|Secondary|Count of Participants With Treatment-Emergent Adverse Events (TEAEs)|"Treatment-Emergent Adverse Events defined as adverse events occurring after the first intake of study treatment (or the same day).~The investigator assessed relation to study treatment as a binary question: Reasonable possibility of relatedness or no reasonable possibility of relatedness. The expression “reasonable possibility of relatedness” is meant to convey in general that there are facts (evidence) or arguments meant to suggest a causal relationship.~A serious AE results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or an important medical event.~The investigator rates the severity of the AE based on a three point scale: mild, moderate or severe. A severe event prevents any usual routine activity of the participant and causes severe discomfort."|Day 0 to Week 8|Safety population: all randomised patients who took at least one dose of study medication|||percentage of participants|||Number
1445900|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Mass Index (BMI)||Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.|||kilograms/meters^2||Standard Deviation|Mean
1445901|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4 and 8 in Body Weight|Body weight was measured at all study visits as part of the physical examination.|Day 0 (baseline), Weeks 2, 4 and 8|Intent-to-Treat (ITT) Population, observed values. Two participants from both treatment arms were missing data at Week 4. Three participants from Bramitob and 4 participants from TOBI were missing data at Week 8.|||kilograms||Standard Deviation|Mean
1445902|NCT00885365|Secondary|Microbiological Outcome Summary by Visit|"Microbiological outcomes are derived considering all P. aeruginosa (PA) morphotypes together.~Week 4 and Week 8 microbiological outcomes:~Eradication = elimination of PA~Persistence = persistence of PA detected at previous visit~Superinfection = appearance of a pathogen (other than PA) not detected at previous visit~Re-infection (week 8 only) = re-appearance of PA detected at Screening and eradicated at Week 4~Superinfection supersedes eradication. Persistence for P. aeruginosa supersedes superinfection.~Re-infection for P. aeruginosa supersedes superinfection."|Day -10 to -1 (screening), Weeks 4 and 8|Intent-to-Treat Population.|||percentage of participants|||Number
1445942|NCT00885118|Secondary|fe0-24,ss|fraction of the analyte excreted unchanged in urine at steady state from time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
1445903|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 90% (MIC90) of Pseudomonas Aeruginosa|"MIC90 is the concentration of tobramycin required to inhibit 90% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:~Morphotype 1: mucoid~Morphotype 2: dry~Morphotype 3: variant~Overall MIC90 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population|||micrograms/milliliters|||Number
1445904|NCT00885365|Secondary|Minimal Inhibitory Concentration Inhibiting Growth of 50% (MIC50) of Pseudomonas Aeruginosa|"MIC50 is the concentration of tobramycin required to inhibit 50% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:~Morphotype 1: mucoid~Morphotype 2: dry~Morphotype 3: variant~Overall MIC50 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used."|Week 4, Week 8|Intent-to-Treat (ITT) Population|||micrograms/milliliters|||Number
1445905|NCT00885365|Secondary|Change From Baseline to End of Weeks 4 and 8 in Pseudomonas Aeruginosa Log10 Bacterial Load in Sputum|If a participant had more than one Pseudomonas aeruginosa (PA) morphotype at a given visit, and therefore more than one bacterial load value, then the bacterial load value corresponding to the highest tobramycin minimal inhibitory concentration (MIC) value regardless of the PA morphotype was used. If the tobramycin MIC value was the same for different PA morphotypes, then the bacterial load value corresponding to morphotype 1 (mucoid colony) was used. If morphotype 1 was not available, bacterial load value corresponding to morphotype 2 (dry colony) was used.|Day -10 to -1 (baseline), Week 4, Week 8|Intent-to-Treat (ITT) Population; At Week 4, six Bramitob patients and seven TOBI patients were missing sputum samples. At Week 8, 11 Bramitob patients and 16 TOBI patients were missing sputum samples.|||colony forming units/gram||Standard Deviation|Mean
1445906|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%)|Difference in the forced expiratory flow rate in mid-exhalation measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.|||liters/second||Standard Deviation|Mean
1445907|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%), Expressed as Percentage of Predicted Normal|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated). Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEF 25-75% values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEF 25-75% test.|||percentage predicted FEF 25-75%||Standard Deviation|Mean
1445908|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.|||liters||Standard Deviation|Mean
1445909|NCT00885365|Secondary|Change From Baseline at End of Weeks 2, 4, and 8 of Forced Vital Capacity (FVC) Expressed as Percentage of Predicted Normal|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FVC values for children were different than the reference normal values used with adult participants.|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FVC test.|||percentage predicted FVC||Standard Deviation|Mean
1445910|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Expiratory Volume in 1 Second (FEV1)|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.|||liters||Standard Deviation|Mean
1445911|NCT00885365|Secondary|Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).|Day 0 (baseline), Week 2, Week 4, Week 8|Intent-to-Treat (ITT) Population, observed values. Differences in number of participants analyzed to the ITT population represent participants who missed visits, or failed to take the FEV1 test.|||percentage predicted FEV1||Standard Deviation|Mean
1445941|NCT00885118|Secondary|CLR,ss|renal clearance of the analyte at steady state determined over the dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 0-5h, 5-12h, 12-24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1445912|NCT00885365|Primary|Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal|Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded.|Day 0 (baseline), Week 4|Intent-to-Treat (ITT) Population, Last Observation Carried Forward (LOCF)|||percentage predicted FEV1||Standard Deviation|Mean
1445913|NCT00885352|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
1445914|NCT00885352|Secondary|Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.|||mg/dL||95% Confidence Interval|Least Squares Mean
1445915|NCT00885352|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 26|Change from baseline reflects the Week 26 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 26|Full analysis set excluded participants without baseline or post-baseline data. Full analysis set with last observation carried forward.|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1445916|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24|The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had 25(OH)D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445917|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24|1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had 1,25(OH)2 D data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445918|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24|Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had SPH data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445919|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24|Serum phosphate is an index of mineral homeostasis.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had serum phosphate data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445920|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24|Serum calcium is an index of calcium homeostasis.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had serum calcium data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445921|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12|s-P1NP is a biochemical marker of bone formation.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445922|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24|Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had S-P1NP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445923|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12|BSAP is a biochemical marker of bone formation.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445924|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24|Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had BSAP data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445925|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12|u-NTx/Cr is a biochemical marker of bone resorption.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445926|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24|N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had u-NTx/Cr data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445927|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed s-CTx at Month 12|s-CTx is a biochemical marker of bone resorption.|Baseline and Month 12|The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 12 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445928|NCT00885170|Secondary|Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24|s-CTx is a biochemical marker of bone resorption.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had s-CTx data at Baseline and Month 24 but excluded participants due to important protocol deviations that may have substantially affected the results such as use of concomitant medication, lack of study medication compliance, and medical history.|||Percent change||95% Confidence Interval|Least Squares Mean
1445929|NCT00885170|Secondary|Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12|BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445930|NCT00885170|Secondary|Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24|BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had 1/3 distal forearm BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445931|NCT00885170|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12|BMD at the lumbar spine was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445932|NCT00885170|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 24|BMD at the lumbar spine was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had lumbar spine BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445933|NCT00885170|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12|BMD at the total hip was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445934|NCT00885170|Secondary|Percent Change From Baseline in Total Hip BMD at Month 24|BMD at the total hip was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had total hip BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445935|NCT00885170|Secondary|Percent Change From Baseline in Trochanter BMD at Month 12|BMD at the trochanter was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445936|NCT00885170|Secondary|Percent Change From Baseline in Trochanter BMD at Month 24|BMD at the trochanter was assessed by DXA at baseline and Month 24.|Baseline and 24 Months|The population analyzed included all randomized, treated participants who had trochanter BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445937|NCT00885170|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 12|BMD at the femoral neck was assessed by DXA at baseline and Month 12.|Baseline and 12 Months|The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 12.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445938|NCT00885170|Primary|Percentage of Participants Discontinuing Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to 24 months|The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.|||Percentage of participants|||Number
1445939|NCT00885170|Primary|Percentage of Participants Experiencing One or More Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to 25 months|The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.|||Percentage of participants|||Number
1445940|NCT00885170|Primary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24|BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.|Baseline and Month 24|The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 24.|||Percent Change||95% Confidence Interval|Least Squares Mean
1445943|NCT00885118|Secondary|Ae0-24,ss|amount of the analyte that is eliminated in urine at steady state over the time interval 0 to 24|0-5, 5-12, 12-24 hour after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol||Geometric Coefficient of Variation|Geometric Mean
1445944|NCT00885118|Secondary|RA,AUC|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on AUCτ|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||ratio||Geometric Coefficient of Variation|Geometric Mean
1445945|NCT00885118|Secondary|RA,Cmax|accumulation ratios of the analyte in plasma after 28 doses (once daily) over a uniform dosing interval τ, based on Cmax|Predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration, and predose, 15min, 30min, 45min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||ratio||Geometric Coefficient of Variation|Geometric Mean
1445946|NCT00885118|Secondary|Vz/F,ss|apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||Liter||Geometric Coefficient of Variation|Geometric Mean
1445947|NCT00885118|Secondary|CL/F,ss|apparent clearance of the analyte in plasma after extravascular administration at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1445948|NCT00885118|Secondary|t1/2,ss|terminal half-life of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||hour||Geometric Coefficient of Variation|Geometric Mean
1445949|NCT00885118|Secondary|Cmax,ss|maximum measured concentration of the analyte in plasma at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h 48h, 72h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1445950|NCT00885118|Secondary|AUCτ,ss|area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ at steady state|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h after last drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1445951|NCT00885118|Secondary|CLR,0-24|renal clearance of the analyte in plasma after extravascular administration – based on 0-24 hours data|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min, 0-5h, 5-12h, 12-24h after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1445952|NCT00885118|Secondary|fe0-24|fraction of the analyte excreted unchanged in urine from time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||percentage of Ae0-24 (to dosage)||Geometric Coefficient of Variation|Geometric Mean
1445953|NCT00885118|Secondary|Ae0-24|amount of the analyte that is eliminated in urine over the time interval 0 to 24|0-5, 5-12, 12-24 hour after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol||Geometric Coefficient of Variation|Geometric Mean
1445954|NCT00885118|Secondary|Vz/F|apparent volume of distribution during the terminal phase λz following an extravascular dose|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||Liter||Geometric Coefficient of Variation|Geometric Mean
1445955|NCT00885118|Secondary|CL/F|apparent clearance of the analyte in plasma after extravascular administration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1445956|NCT00885118|Secondary|t1/2|terminal half-life of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||hour||Geometric Coefficient of Variation|Geometric Mean
1445957|NCT00885118|Secondary|Cmax|maximum measured concentration of the analyte in plasma|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1445958|NCT00885118|Secondary|AUC0-∞|area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1448683|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 2|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 2|FAS (LOCF)|||participants|||Number
1445959|NCT00885118|Secondary|AUC0-tz|area under the concentration-time curve of the analyte in plasma over the time interval from 0 to last quantifiable plasma concentration|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1445960|NCT00885118|Secondary|AUCτ,1|Area under the concentration-time curve of the analyte in plasma after administration of the first dose over a uniform dosing interval τ|Predose and 15 minutes (min), 30min, 45min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 23h55min after first drug administration|Pharmacokinetic analysis set: all patients who received at least one dose of BI 10773 and had some pharmacokinetic data|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
1445961|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of insulin levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)|||hr*uU/mL||Standard Error|Least Squares Mean
1445962|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of glucagon levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)|||hr*pg/mL||Standard Error|Least Squares Mean
1445963|NCT00885118|Secondary|Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test)|Change from baseline in the area under the curve of plasma glucose levels until 4 hours after intake of a standardised food (meal tolerance test) to 28 days|baseline and 28 days|Full analysis set (FAS)|||hr*mg/dL||Standard Error|Least Squares Mean
1445964|NCT00885118|Secondary|Change From Baseline in Fasting Insulin|Change from baseline in Fasting insulin to 28 days|baseline and 28 days|Full analysis set (FAS)|||uU/mL||Standard Error|Least Squares Mean
1445965|NCT00885118|Secondary|Change From Baseline in 1,5-anhydroglucitol|Change from baseline in 1,5-anhydroglucitol to 28 days|baseline and 28 days|Full analysis set (FAS)|||ug/mL||Standard Error|Least Squares Mean
1445966|NCT00885118|Secondary|Change From Baseline in Fructosamine|Change from baseline in Fructosamine to 28 days|baseline and 28 days|Full analysis set (FAS)|||umol/L||Standard Error|Least Squares Mean
1445967|NCT00885118|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c to 28 days|baseline and 28 days|Full analysis set (FAS)|||percentage of HbA1c||Standard Error|Least Squares Mean
1445968|NCT00885118|Primary|Change From Baseline in 8-point Glucose|Change from baseline in 8-point glucose to 27 days|baseline and 27 days|Full analysis set (FAS)|||mg/dL||Standard Error|Least Squares Mean
1445969|NCT00885118|Primary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose to 28 days|baseline and 28 days|Full analysis set (FAS)|||mg/dL||Standard Error|Least Squares Mean
1445970|NCT00885118|Primary|Change From Baseline in Urine Glucose Excretion|Change from baseline in Urine glucose excretion to 28 days|baseline and 28 days|Full analysis set (FAS)|||mg||Standard Error|Least Squares Mean
1445971|NCT00885105|Other Pre-specified|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.|Days 0 up to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population|||Percentage of Participants|||Number
1445972|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Antibodies to polio viruses were measured by a serum neutralization assay.|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for the Polio antibodies were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1445973|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.|Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal antibodies were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1445974|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.|"Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).~Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.~The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay."|Day 28 Post-vaccination|GMTs to the Pertussis, Tetanus, Diphtheria and Haemophilus Influenzae antigens were assessed in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
1445975|NCT00885105|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.|Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.|Day 28 Post-vaccination|Geometric Mean Titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
1445976|NCT00885105|Primary|Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.|Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.|Day 28 Post-vaccination|Hemagglutination inhibition titers to the Influenza vaccine antigens were assessed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1446065|NCT00884221|Secondary|Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
1445977|NCT00885092|Secondary|Percentage of Participants With Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.|||Percentage of participants|||Number
1445978|NCT00885092|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, My lenses feel comfortable right now, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.|||Units on a scale||Standard Deviation|Mean
1445979|NCT00885092|Primary|Mean Ex-Vivo Wetting Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 7, Hour 14|Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.|||Degrees||Standard Deviation|Mean
1445980|NCT00885079|Primary|Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining sdore from 0 to 3, and the total score was calculated (0-18). 0 is better. Superiority was verified by comparing t-test results for change from baseline in the LGCS score (LOCF) between 2 treatment groups.|Baseline, Weeks4||||units on a scale||Standard Deviation|Mean
1445981|NCT00885079|Primary|Change in Fluorescein Corneal Staining (FCS) Score From Baseline|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Noninferiority for change from baseline in the FCS score (LOCF) was determined by comparing the noninferiority margin (0.4) with the upper limit of the 95% confidence interval (CI) of the difference between the 2 treatment groups|Baseline, Weeks4||||units on a scale||Standard Deviation|Mean
1445982|NCT00884949|Primary|Subject Incidence of Treatment Emergent AEs|"The primary objective of the study was to evaluate the safety of weekly infusions of BMN 110 administered in escalating doses to subjects with MPS IVA.~The safety variable incidence of TEAE is summarized."|Entire Study, through week 84||||participants|||Number
1445983|NCT00884949|Secondary|Percent Change From Baseline in FVC|Percent Change from baseline in Forced Vital Capacity.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage of FVC||Standard Deviation|Mean
1445984|NCT00884949|Secondary|Percent Change From Baseline in MVV|Percent Change from baseline in Maximum Voluntary Ventilation.|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage of MVV||Standard Deviation|Mean
1445985|NCT00884949|Secondary|Percent Change From Baseline in uKS|Percent Change from baseline in Normalized Urine KS. The percent change was calculated (Week X value - baseline value)/baseline value *100%|Baseline to Weeks 12, 24, 36, 72|Intent-to-Treat population (all subjects who enrolled in the study). The analysis was based on observed cases.|||percentage of uKS||Standard Deviation|Mean
1445986|NCT00884949|Secondary|Change From Baseline in 3MSCT|Change from baseline in the 3-minute Stair Climb Test. Patients walked up stairs that have a railing, which could be used for support, for 3 minutes, with the number of stairs climbed recorded. The test result was the number of steps climbed per minute.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). One patient was developmentally unable to perform the 3MSCT and the test scores were set to missing. The analysis was based on observed cases.|||steps/min||Standard Deviation|Mean
1445987|NCT00884949|Secondary|Change From Baseline in 6MWT|Change from baseline in meters in 6-minute Walk Test. As a measure of endurance, a 6-minute walk test (6MWT) was performed according to the American Thoracic Society Guidelines. Patients were instructed to walk as far as possible in 6 minutes.|Baseline to Weeks 12, 24, 36, 48, 72|Intent-to-Treat population (all subjects who enrolled in the study). Two patients were either physically (score was designated as 0 m) or developmentally (score was set to missing) unable to perform the 6MWT. The analysis was based on observed cases.|||meters||Standard Deviation|Mean
1445988|NCT00884910|Primary|Patient Preference|"Patients were asked Which voice prosthesis do you prefer? Answer options were old one (Provox2), new one (Provox Vega 22.5), or no preference."|3 months post insertion, or at end of device life (whichever comes sooner)|All patients that participated in the study and finished it were analyzed|||Patients|||Number
1445989|NCT00884910|Secondary|Device Life Time|Periodic replacement of voice prostheses is considered a normal event. Over time, the device is affected by Candida which may hinder closure of the valve flap. The device life time of the voice prosthesis is determined by leakage through the device that occurs because of incomplete closure of the valve flap. At the time of analysis (6 months after placement of the devices), 25 devices had been replaced because of leakage through the device and 8 devices were still in situ. The outcomes that are reported concern the 25 devices that had been replaced.|6 months|Six months after placement of the devices, 25 out of 33 had been replaced for leakage through the device. The median device life time is based on all 33 devices. The maximum of the range reflects the 6 months cut off and not the actual maximum device life time, because of the devices still in situ at the time of analysis.|||Days||Full Range|Median
1445990|NCT00884897|Secondary|To Determine Whether OT Improves Measures of Social Anxiety.|To determine whether OT improves measures of social anxiety as measured by the Social Interaction Anxiety Scale. This assessment has 20 items scored 0-4 for a total minimum score of 0 and maximum score of 80. The lower the score the better the outcome.|Outcomes are compared between Baseline and endpoint||||units on a scale||Standard Deviation|Mean
1445991|NCT00884897|Primary|To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients|Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.|participants are assessed at baseline and end point||||units on a scale||Standard Deviation|Mean
1445992|NCT00884832|Secondary|Percentage of Days With FI Post-treatment Adjusted for Baseline|The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.|4 weeks treatment||||percentage of days||Standard Error|Mean
1445993|NCT00884832|Secondary|Percentage of Days With Fecal Incontinence (FI)||4 weeks baseline, 4 weeks treatment||||percentage of days||Standard Error|Mean
1445994|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools Post-treatment Adjusted for Baseline|The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. The “adjustment for baseline” was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint.|4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
1445995|NCT00884832|Secondary|Percentage of Bowel Movements With Semi-formed and Loose Stools in Subjects With and Without Diarrhea|The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
1445996|NCT00884832|Secondary|Percentage of Bowel Movements Preceded by Rectal Urgency|Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
1445997|NCT00884832|Secondary|Satisfaction With Treatment|"This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = Not satisfied at all (no relief of symptoms) to 100 = Completely satisfied (symptoms resolved). The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods."|4 weeks baseline, 4 week treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
1445998|NCT00884832|Secondary|Impact of Fecal Incontinence on Post-Treatment Quality of Life|"Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|after 4 weeks treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
1445999|NCT00884832|Secondary|Impact of Fecal Incontinence on Baseline Quality of Life|"Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)."|4 weeks baseline|Intent to treat analysis|||units on a scale||Standard Error|Mean
1446000|NCT00884832|Secondary|Mean Severity of Fecal Incontinence|The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
1446001|NCT00884832|Secondary|Mean Percentage of Bowel Movements Which Were Incontinent|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||percentage of bowel movements||Standard Error|Mean
1446002|NCT00884832|Secondary|Mean Number of Fecal Incontinence Episodes|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||number of episodes||Standard Error|Mean
1446003|NCT00884832|Secondary|Mean Number of Days With Fecal Incontinence|Values were averaged over 4 week baseline and 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||days||Standard Error|Mean
1446004|NCT00884832|Primary|Mean Fecal Incontinence and Constipation Assessment (FICA) Score|The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1–6, 7–10, and 11–13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods.|4 weeks baseline, 4 weeks treatment|Intent to treat analysis|||units on a scale||Standard Error|Mean
1446005|NCT00884806|Secondary|Mean Lens Comfort|"Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, Over the previous 2-3 hours, my lenses felt comfortable, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree."|Day 7|Intent to treat: All participant who received regimen and had at least one on-therapy study visit.|||Units on a scale||Standard Deviation|Mean
1446066|NCT00884221|Secondary|Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set||Post-trial information|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
1446006|NCT00884806|Primary|Solution-Related Corneal Staining|Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.|Day 7|Intent to treat: All participants who received regimen and had at least one on-therapy visit.|||Percentage of participants|||Number
1446007|NCT00884793|Secondary|"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"|Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry|12 weeks|All patients who had endoscopy at week 12.|||percentage change||Standard Error|Mean
1446008|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4% in the Ileum.|Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum|12 weeks|Includes all those who had endoscopy at week 12|||participants|||Number
1446009|NCT00884793|Secondary|Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.|Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12.|12 weeks|Includes all with gut samples from week 12.|||participants|||Number
1446010|NCT00884793|Primary|Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum|Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum|12 weeks|We analyzed data from all subjects who had endosocopies at week 12.|||participants|||Number
1446011|NCT00884754|Primary|Time to Intubation (Seconds)||30-150 seconds (anticipated)||||seconds||Inter-Quartile Range|Median
1446012|NCT00884741|Other Pre-specified|Neurocognitive Function Measured by the Hopkins Verbal Learning Test-Revised(HVLT-R), Trail Making Test Part A, Trail Making Test Part B, Controlled Oral Word Association Test (COWAT)||Analysis can occur at or after time of primary outcome measure analysis.|||||||
1446013|NCT00884741|Other Pre-specified|Quality of Life Measured by the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT Tool) and EORTC Quality of Life Questionnaire-Core/Brain Cancer Module( QLQ-C30/BCM20)||Analysis can occur at or after time of primary outcome measure analysis.|||||||
1446014|NCT00884741|Secondary|Incidence of Grade 3 and Higher Treatment-related Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 3.0|AEs are graded by using CTCAE 3.0. The difference between the two randomized arms in the percentage of patients with grade 3 or higher toxicities reported as possibly/probably/definitely related to protocol treatment will be tested using a chi square test.|Up to 30 days|Eligible randomized patients with adverse event data who started study treatment.|||participants|||Number
1446015|NCT00884741|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as time from randomization to date of progression, death, or last follow-up, and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients|||months||95% Confidence Interval|Median
1446016|NCT00884741|Primary|Overall Survival (OS)|Survival time was defined as time from randomization to date of death from any cause and was estimated by the Kaplan-Meier method. Patients last known to be alive were censored at the date of last contact. This analysis was planned to occur when 390 deaths had been reported.|From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.|All eligible randomized patients|||months||95% Confidence Interval|Median
1446017|NCT00884611|Secondary|Mean Morning Blood Glucose (BG)|Desirable glucose level was 70-180 mg/mL. Average of all morning BG data is presented. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.|21 days|Participants who were treated and had data for the respective algorithm were included in the analysis.|||mg/dL||Standard Deviation|Mean
1446018|NCT00884611|Secondary|Percentage of Nights With CGM Values >180 mg/dL|Nights with CGM sensor values >180 mg/dL were considered to be undesirable. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.|21 days|Participants who were treated and had data for the respective algorithm were included in the analysis.|||percentage of nights|Nights||Number
1446019|NCT00884611|Primary|Percentage of Nights With CGM (Continuous Glucose Monitor) Sensor Values < 60 mg/dL|Nights with CGM sensor values < 60 mg/dL were considered to be undesirable. A Kalman filter-based model algorithm predicted whether the sensor glucose level would fall below 80 mg/dL and would suspend insulin delivery as needed. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.|21 days|Participants who were treated and had data for the respective algorithm were included in the analysis.|||percentage of nights|Nights||Number
1446020|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Punctate Corneal Staining Score|Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Baseline, Month 2||||Percentage of Patients|||Number
1446021|NCT00884585|Secondary|Percentage of Patients With an Improvement in the Composite Symptom Score|Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.|Baseline, Month 2|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1446022|NCT00884585|Secondary|Percentage of Punctate Corneal Staining Responders|Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.|Month 2|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1446023|NCT00884585|Primary|Percentage of Treatment Responders|Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).|Baseline, Month 2|Intent to Treat: all randomized patients|||Percentage of Patients|||Number
1446024|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the Prophylaxis Setting|The calculation of incidence of prophylaxis LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the Prophylactic LETE CRF), and the denominator was the number of routine prophylaxis infusions. Each infusion was classified in the infusion log (“Prophylaxis/ On Demand/ Preventive”), and participants were instructed to select “On Demand” if the infusion was to treat a bleed, even if the participant typically followed a prophylaxis regimen. Only the infusions classified as “Prophylaxis” were counted in this denominator.|100 exposure days to study medication (approx. 2 years)||||percentage of bleeding episodes||95% Confidence Interval|Number
1446025|NCT00884390|Secondary|Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting|The calculation of incidence of on-demand LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the On Demand LETE CRF), and the denominator was the number of bleeding episodes treated in an on-demand setting. This denominator could include new bleeding episodes in prophylaxis participants breakthrough bleeds), and if subsequent on-demand doses for such a bleed met the on-demand LETE criteria, then an on-demand LETE was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||percentage of bleeds LETE||95% Confidence Interval|Number
1446026|NCT00884390|Secondary|Average Infusion Dose|The average infusion dose for each participant was calculated as his total factor consumption (in IU) divided by the number of infusions administered. Summary statistics were reported for both of these variables separately for those participants classified at baseline as following an on-demand regimen, and for those on a primary or secondary prophylaxis regimen.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||IU||Standard Deviation|Mean
1446027|NCT00884390|Secondary|TFC Following a Prophylaxis Regimen at Baseline for All Participants|The total amount (in IU) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||IU||Standard Deviation|Mean
1446028|NCT00884390|Secondary|Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants|The total amount (in International Units [IU]) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||International Units (IU)||Standard Deviation|Mean
1446029|NCT00884390|Secondary|Number of Participants With Breakthrough Bleeds|The number of participants with any breakthrough bleed was reported.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||participants|||Number
1446030|NCT00884390|Secondary|Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion|First, the bleed start time from the Infusion Log Diary CRF was used to determine the number of breakthrough bleeds that occurred ≤48 hours after an infusion marked as “Prophylaxis” (which had no associated bleed). If there was more than 1 bleed location (ie, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence. If a response was given, or if a bleed time was given, but “On Demand” was not listed as “treatment type”, it was still counted as an on-demand bleed for analyses/summaries. Bleeding episodes were not categorized as spontaneous (atraumatic) or traumatic.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||bleeds|||Number
1446031|NCT00884390|Secondary|Number of ReFacto AF Infusions to Treat Each New Bleed|The Infusion Log Diary case report form (CRF) was used to determine the number of test article infusions administered to treat a bleed. This was calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time).|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of Infusions||Standard Deviation|Mean
1446041|NCT00884325|Secondary|Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30)|Baseline - Week 2 - Week 4||||units on a scale||Inter-Quartile Range|Median
1446101|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Adults Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.|||participants|||Number
1446032|NCT00884390|Secondary|Response Assessment of First On-demand Treatment of New Bleeds|"A 4-point scale of assessment of ‘on-demand’ treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as:~Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered.~Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered.~Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode.~No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens."|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of observations|||Number
1446033|NCT00884390|Secondary|Annualized Bleeding Rates (ABRs)|An ABR for each participant will be calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by his total therapy duration (in days), then multiplied by 365.25.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of bleeds||Standard Deviation|Mean
1446034|NCT00884390|Primary|Number of Participants With Clinically Significant Factor VIII Inhibitor Development|Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication.|100 exposure days to study medication (approx. 2 years)|All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses.|||Number of participants||95% Confidence Interval|Number
1446035|NCT00884377|Secondary|Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial|Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject’s infecting parasite. If an L. major infection could not be confirmed in a subject’s lesion(s), then that subject could not be treated under this protocol.|at baseline before treatment||||Participants|||Count of Participants
1446036|NCT00884377|Secondary|Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments|Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.|day 1 and day 10|Percent of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10|||% of T-cells||95% Confidence Interval|Mean
1446037|NCT00884377|Secondary|Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments|Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.|day 1 and day 10|Populations of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10|||populations of T-cells||95% Confidence Interval|Mean
1446038|NCT00884377|Secondary|Number of Participants With Solicited Adverse Events|To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events|Days 3, 7 and 10|Data ia showing only subjects with specified solicited symptoms on Days 3, 7 and 10. Collective count of participants for SSG is 53 and 28 for ThermoMed over all reported days.|||subjects showing specified symptoms|||Number
1446039|NCT00884377|Secondary|Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure|Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject’s study group. On the basis of these photo assessments, “clinical response” was assessed by lesion and by subject. In addition, an “overall response” was assigned (“healed” or “not healed”) based on a combination of experts’ photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.|12 months||||Participants|||Count of Participants
1446040|NCT00884377|Primary|Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure|Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject’s study group. On the basis of these photo assessments, “clinical response” was assessed by lesion and by subject. In addition, an “overall response” was assigned (“healed” or “not healed”) based on a combination of experts’ photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.|Assessment of cure is made at 2 months after treatment|A sample size of 27 subjects per treatment group was planned based on the assumption that the cure rate in the heat treatment arm would be 73% (Navin et al., 1990), compared to a 99% cure rate in the sodium stibogluconate arm (Wortmann et al., 2002).|||Participants|||Count of Participants
1446042|NCT00884325|Primary|Pruritus VAS Scores at Baseline, Week 2 and Week 4|Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.|Baseline - Week 2-Week 4||||units on a scale||Inter-Quartile Range|Median
1446043|NCT00884312|Secondary|Time to Progression|Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency.|From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data Only participants with regimens that continued from the initial study without baseline being reset are included.|||months||95% Confidence Interval|Median
1446044|NCT00884312|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first.~Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants.~PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency."|From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data. Only participants with regimens that continued from the initial study without baseline being reset are included.|||months||95% Confidence Interval|Median
1446045|NCT00884312|Secondary|Overall Survival|Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported.|From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.|||participants|||Number
1446046|NCT00884312|Primary|Number of Participants With Adverse Events|"Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0.~Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade).~A serious AE is one that met one or more of the following criteria:~Death~Life threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~A congenital anomaly/birth defect in the offspring of an exposed subject~Important medical events that, based upon appropriate medical judgment, jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above."|From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.|||participants|||Number
1446047|NCT00884312|Primary|Number of Participants With Peripheral Neuropathy|Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain.|From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.|All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.|||participants|||Number
1446048|NCT00884286|Secondary|Overall Survival|Overall survival (OS) was to be calculated from the date of registration to the date of death from any cause. Patients with no documented death were to be censored at the last date they were known to be alive.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
1446049|NCT00884286|Secondary|Progression-free Survival|"Progression-free survival (PFS) was to be calculated from the date of registration to the date of first objective disease progression or death from any cause. Patients who were lost to follow-up without documentation of progression were to be censored at the last date they were assessed and found progression-free.~A patient receiving a new treatment in the absence of documented progression was to be considered as progressing at the time of re-treatment."|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
1446050|NCT00884286|Secondary|Time to Subsequent Chemotherapy|Time to subsequent therapy was to be calculated from the first infusion of the study drug to the start date of the subsequent therapy. Patients without subsequent therapy were to be censored at their last reported date.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
1446051|NCT00884286|Secondary|Time to Progression|Time to progression (TTP) was to be calculated from the first day of plitidepsin treatment to the date of disease progression.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.|||months||95% Confidence Interval|Median
1446052|NCT00884286|Secondary|Duration of Response|Duration of response was defined as the time from the first documented objective response (CR, CRu or PR) to disease progression or death. Patients who had not progressed or died were to have their duration censored at the date of their last disease assessment.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|"The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.~The six responders belong to the Non-cutaneous PTCL cohort."|||months||95% Confidence Interval|Median
1446053|NCT00884286|Secondary|Time to Response Onset|Time to response onset was defined as the time from the first day of plitidepsin treatment to the first documentation of response.|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|"The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous PTCL, and for the subset of treated patients with other lymphomas.~Six responders belong to the Non-cutaneous PTCL cohort"|||weeks||95% Confidence Interval|Median
1446054|NCT00884286|Primary|Objective Response Rate|"The primary objective of the study was the exploration of the efficacy of plitidepsin when given as a weekly 1-hour infusion on Days 1, 8 and 15 in 4-week cycles to patients with relapsed or refractory aggressive non-Hodgkin's Lymphoma.~The primary efficacy endpoint was the Objective Response Rate, defined as the combined rate of Complete Response (CR), Unconfirmed Complete Response (CRu) and Partial Response (PR) following the definition of response according to the International Working Group (IWG) criteria for Non-Hodgkin’s Lymphoma (NHL)."|All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first|The efficacy and safety analyses were to be performed separately for the subset of treated patients with non-cutaneous Peripheral T-cell Lymphoma (PTCL), and for the subset of treated patients with other lymphomas.|||Participants|||Count of Participants
1446055|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).|||milliliter||Standard Deviation|Mean
1446056|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety Analysis Set.|||participants|||Number
1446057|NCT00884273|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety Analysis Set.|||participants|||Number
1446058|NCT00884273|Secondary|Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII)|The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.|||scores on a scale||Standard Deviation|Mean
1446059|NCT00884273|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS.|||scores on a scale||Standard Deviation|Mean
1446060|NCT00884273|Secondary|Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.|||nanograms per milliliter||Full Range|Median
1446061|NCT00884273|Secondary|Change in Serum Testosterone Levels During the Study||At 4, 8, and 12 weeks compared to baseline.|FAS.|||nanograms per milliliter||Full Range|Median
1446062|NCT00884273|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
1446063|NCT00884273|Secondary|Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8|TRUS is a method of measuring the size of the prostate.|After treatment of 4 and 8 weeks compared to Baseline|FAS, Last Observation Carried Forward (LOCF).|||milliliter||Standard Deviation|Mean
1446064|NCT00884273|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF).|||milliliter||Standard Deviation|Mean
1446067|NCT00884221|Secondary|Blastocyst Quality, Intention-to-treat (ITT) Analysis Set|"Blastocyst quality on day 5 was based on the blastocyst expansion and hatching status, inner cell mass grading and trophectoderm grading.~Excellent-quality blastocysts were defined as those with blastocyst expansion and hatching status 4, 5 or 6, inner cell mass grading A, and trophectoderm grading A or B. Good-quality blastocysts were defined as those with blastocyst expansion and hatching status 3, 4, 5 or 6, inner cell mass grading A or B, and trophectoderm grading A or B."|5 days after oocyte retrieval (120h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Number of blastocysts||Standard Deviation|Mean
1446068|NCT00884221|Secondary|Fertilization, Intention-to-treat (ITT) Analysis Set|Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized. Fertilization was estimated as (Number of oocytes with 2 pronuclei / number of metaphase II oocytes)*100|1 day after oocyte retrieval (19 h post-insemination)|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of metaphase II oocytes||Standard Deviation|Mean
1446069|NCT00884221|Secondary|Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set|Oocyte retrieval took place 36h (± 2h) after hCG administration. At oocyte retrieval, the number of oocytes retrieved was recorded.|36 h after hCG|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Oocytes per participant||Standard Deviation|Mean
1446070|NCT00884221|Secondary|Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set|During the controlled ovarian stimulation, transvaginal ultrasound was performed to count the number of follicles and measure the size of the follicles.|Last stimulation day|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Follicles per participant||Standard Deviation|Mean
1446071|NCT00884221|Secondary|Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||nmol/L||Standard Deviation|Mean
1446072|NCT00884221|Secondary|Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||nmol/L||Standard Deviation|Mean
1446073|NCT00884221|Secondary|Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||pmol/L||Standard Deviation|Mean
1446074|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The per-protocol (PP) analysis set was defined as all randomized and exposed participants except those excluded as a result of major protocol deviations, such as significant non-compliance or other serious unforeseen deviations deemed to invalidate the data and affect the conclusions of the trial.|||Percentage of participants||Standard Deviation|Mean
1446075|NCT00884221|Secondary|Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||nmol/L||Standard Deviation|Mean
1446076|NCT00884221|Secondary|Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||IU/L||Standard Deviation|Mean
1446077|NCT00884221|Secondary|Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn. Free androgen index = (testosterone (nmol/L)/ sex hormone binding globulin (nmol/L))*100|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
1446078|NCT00884221|Secondary|Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||IU/L||Standard Deviation|Mean
1446079|NCT00884221|Secondary|Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set|Blood samples for analysis of circulating concentrations of endocrine parameters were drawn|On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||pmol/L||Standard Deviation|Mean
1448684|NCT00860262|Secondary|Number of Patients Achieving Various Blood Pressure Response Levels at Week 1|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 1|FAS (LOCF)|||participants|||Number
1446080|NCT00884221|Primary|Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set|Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage|10-11 weeks after embryo transfer at the blastocyst stage|The intention-to-treat (ITT) analysis set was defined as all randomized and exposed participants. Participants were analyzed according to actual treatment.|||Percentage of participants||Standard Deviation|Mean
1446081|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.|||degrees Celsius||Standard Deviation|Mean
1446082|NCT00884117|Secondary|Body Temperature Among Children Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|"ALCIP Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table."|||degrees Celsius||Standard Deviation|Mean
1446083|NCT00884117|Secondary|Change From Baseline in Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. The change in body temperature between visits was averaged among all participants and expressed in degrees Celsius.|Baseline (Day 1) to Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at Baseline and Day 10. The number of participants who provided evaluable data for each viral RNA subtype at Baseline and Day 10 (n) is shown in the table.|||degrees Celsius||Standard Deviation|Mean
1446084|NCT00884117|Secondary|Body Temperature Among Adults Treated With Oseltamivir|Body temperature was measured by the Investigator using an oral or tympanic thermometer at Baseline and Day 10. Body temperature at each visit was averaged among all participants and expressed in degrees Celsius.|Days 1, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||degrees Celsius||Standard Deviation|Mean
1446085|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Children Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and energy/tiredness on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
1446086|NCT00884117|Secondary|Total Daily Symptom Score According to Global Assessment by the Investigator Among Adults Treated With Oseltamivir|Symptoms were assessed on Days 1, 6, and 10. The Investigator rated seven symptoms of fever, sore throat, nasal congestion, cough, aches/pains, headache, and fatigue on a scale of 0 (absent/no problem) to 3 (severe/major problem). The global score was calculated as a sum of all individual symptom scores. Global scores may range from 0 to 21, with higher scores indicating worse or more pronounced symptoms.|Days 1, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the specified visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||units on a scale||Standard Deviation|Mean
1446087|NCT00884117|Secondary|Percentage of Participants With Resistant Versus Susceptible Viruses by Baseline Viral Load|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The mean viral load from each sample was expressed in log10 vp/mL and stratified by resistant and susceptible viruses.|Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data. The number of participants who provided evaluable data for each resistance status at Baseline (n) is shown in the table.|||percentage of participants|||Number
1446088|NCT00884117|Secondary|Percentage of Participants by Day of Viral RNA First Not Detected Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as IC50 more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants by earliest post-Baseline test day on which viral RNA was not detected was reported and stratified by resistant and susceptible viruses.|Days 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the specified visit. The number of participants who provided evaluable data for each resistance status at the specified visit (n) is shown in the table.|||percentage of participants|||Number
1448685|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 2|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 2|FAS (LOCF)|||participants|||Number
1446089|NCT00884117|Secondary|Percentage of Participants With Symptom Resolution on Day 6 Comparing Resistant and Susceptible Viruses|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Phenotypic resistance was defined as 50% inhibitory concentration (IC50) more than 10-fold higher than the median value for all viruses of the same subtype. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. Susceptible viruses were those that did not exhibit treatment-emergent resistance. The percentage of participants with mild or absent symptoms on Day 6 was reported and stratified by resistant and susceptible viruses.|Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants with wild-type infection status at Baseline who provided evaluable data at the Day 6 visit. The number of participants who provided evaluable data for each resistance status at the Day 6 visit (n) is shown in the table.|||percentage of participants|||Number
1446090|NCT00884117|Secondary|Viral Load Among Children Treated With Oseltamivir|Viral load was determined for those with detectable virus above the LLQ of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 vp/mL.|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||log10 vp/mL||Standard Deviation|Mean
1446091|NCT00884117|Secondary|Viral Load Among Adults Treated With Oseltamivir|Viral load was determined for those with detectable virus above the lower limit of quantification (LLQ) of 1.82 for influenza A viruses and 1.99 for influenza B viruses. The viral load from each sample was averaged among all participants and expressed in log10 of the number of viral particles per milliliter (log10 vp/mL).|Days 1, 3, 6, 10|ALCIP Population. The “Number of Participants Analyzed” reflects the highest total number of participants who provided evaluable data for their viral RNA subtype at any visit. The number of participants who provided evaluable data for each viral RNA subtype at the specified visit (n) is shown in the table.|||log10 vp/mL||Standard Deviation|Mean
1446092|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With Influenza B Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with influenza B infection who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
1446093|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H1N1pdm09 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H1N1pdm09 infection who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
1446094|NCT00884117|Secondary|Time to Non-Detection of Viral RNA Among Participants With H3N2 Infections|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants with H3N2 infection who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
1446095|NCT00884117|Secondary|Time to Non-Detection of Viral RNA|Time to non-detection/viral clearance was the time between symptom onset and the day on which viral RNA was no longer detected, or the last visit date if the participant was not RNA-negative at that visit. Time to non-detection/viral clearance was estimated using Kaplan-Meier analysis and expressed in days.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10)|ALCIP Population. The “Number of Participants Analyzed” reflects the number of participants who provided sufficient post-Baseline data.|||days||95% Confidence Interval|Median
1446096|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Children Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.|||participants|||Number
1446097|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 6 Among Children Treated With Oseltamivir||Day 6|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 6 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 6 visit (n) is shown in the table.|||participants|||Number
1446098|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Children Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.|||participants|||Number
1446099|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Children Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.|||participants|||Number
1446100|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 10 Among Adults Treated With Oseltamivir||Day 10|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 10 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 10 visit (n) is shown in the table.|||participants|||Number
1446102|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 3 Among Adults Treated With Oseltamivir||Day 3|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Day 3 visit. The number of participants who provided evaluable data for each viral RNA subtype at the Day 3 visit (n) is shown in the table.|||participants|||Number
1446103|NCT00884117|Secondary|Number of Participants With Viral RNA Detected by RT-PCR on Day 1 Among Adults Treated With Oseltamivir||Baseline (Day 1)|ALCIP Population. The “Number of Participants Analyzed” reflects the total number of participants who provided evaluable data for their viral RNA subtype at the Baseline visit.|||participants|||Number
1446104|NCT00884117|Primary|Percentage of Participants Exhibiting Treatment-Emergent Resistance by Study Year Among Participants With H3N2 or H1N1pdm09 Infections|Pre-defined mutations in viral RNA were noted, the presence of which was defined as genotypic resistance. Treatment-emergent resistance was defined as the presence of genotypic or phenotypic resistance from a post-Baseline sample in the setting of a previously non-resistant Baseline sample. The percentage of participants with treatment-emergent resistance was reported by study year for participants with H3N2 or H1N1pdm09 infections. Only data with evaluable participants were reported.|From Baseline (Day 1) to Day 10 (assessed on Days 1, 3, 6, 10) during Study Years 1, 2, 3, 4, 5, 6, 7|ALCIP Population. The “Number of Participants Analyzed” reflects combined H3N2 or H1N1pdm09-infected participants across all study years who provided an analyzable post-Baseline sample for their viral RNA subtype. The number of participants who provided evaluable data for each viral RNA subtype in the specified timeframe (n) is shown in the table.|||percentage of participants|||Number
1446105|NCT00884117|Primary|Number of Participants With Genotypic Resistance|"Samples were analyzed using reverse transcriptase-polymerase chain reaction (RT-PCR). Pre-defined mutations in viral ribonucleic acid (RNA) were noted, the presence of which was defined as genotypic resistance. The number of participants with genotypic resistance at Baseline was reported. The number of participants with genotypic resistance post-Baseline was determined by a collective count of all participants who had a resistance mutation at least once on Days 3, 6, and/or 10. (Hereafter, H stands for hemagglutinin and N stands for neuraminidase in abbreviations of viral subtype such as H1N1, H1N1pdm09, and H3N2.)"|Baseline (Day 1) and post-Baseline (Days 3, 6, 10)|All Laboratory-Confirmed Influenza Participants (ALCIP) Population: All with confirmed influenza by positive RT-PCR at Baseline. The “Number of Participants Analyzed” reflects the total of participants who provided evaluable data for their viral RNA subtype. The number who provided data for each viral RNA subtype in each timeframe (n) is shown.|||participants|||Number
1446106|NCT00884065|Primary|Change in Active Internal Rotation After Intervention Minus Baseline|Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility|Baseline and the same day (just after intervention)||||Centimeters||Standard Deviation|Mean
1446107|NCT00884065|Primary|Change in Active External Rotation After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)||||Sexagesimal degrees||Standard Deviation|Mean
1446108|NCT00884065|Primary|Change in Active extensión Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)||||Sexagesimal degrees||Standard Deviation|Mean
1446109|NCT00884065|Primary|Change in Active Abduction Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination|Baseline and the same day (just after intervention)||||Sexagesimal degrees||Standard Deviation|Mean
1446110|NCT00884065|Primary|Change in Active Flexion Movement After Intervention Minus Baseline|A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)|Baseline and the same day (just after intervention)||||Sexagesimal Degrees||Standard Deviation|Mean
1446111|NCT00884065|Secondary|Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline|An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.|Baseline and the same day (just after intervention)||||Millimeters||Standard Deviation|Mean
1446112|NCT00884039|Primary|Intraocular Pressure Within Normal Limits (<24 mm Hg)|Intraocular pressure was measured by Goldmann applanation tonometry.|1 month|Per protocol|||Participants|||Number
1446113|NCT00883779|Secondary|Median Follow-up Time During the Study|Median follow-up was calculated using 'Reverse Kaplan-Meier' analysis for Overall survival.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 5.5 years])|FAS population.|||months||95% Confidence Interval|Median
1446114|NCT00883779|Secondary|Time to Deterioration in QOL Using FACT-L Version 4.0|"Time to deterioration in QoL is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in Total FACT-L or death on study. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||months||95% Confidence Interval|Median
1446115|NCT00883779|Secondary|Percentage of Participants With Deterioration in Quality of Life (QOL) Using FACT-L Version 4.0|"Total FACT-L score was defined as the sum of the TOI, Social Well Being (SWB) and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 136; higher score indicates better QoL. A clinically meaningful decline used to determine deterioration in QoL was ≥6-point decline from baseline. Participants without deterioration in QoL at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||percentage of participants|||Number
1446116|NCT00883779|Secondary|Time to Deterioration in TOI Using FACT-L Version 4.0|"Time to deterioration in TOI is defined as time from randomization until the earlier of a clinically meaningful decline from baseline in TOI or death on study. TOI is defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of QoL. A clinically meaningful decline used to determine deterioration in TOI was ≥6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||months||95% Confidence Interval|Median
1446117|NCT00883779|Secondary|Percentage of Participants With Deterioration in Trial Outcome Index (TOI) Using FACT-L Version 4.0|"TOI was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L (Version 4.0). Participants responded to questions on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 to 84; higher score indicates better physical aspects of quality of life (QoL). A clinically meaningful decline used to determine deterioration in TOI was greater than or equal to (≥) 6-point decline from baseline. Participants without deterioration in TOI at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||percentage of participants|||Number
1446118|NCT00883779|Secondary|Time to Symptomatic Progression|"Time to symptomatic progression was the time from randomization until the earlier of a clinically meaningful decline from baseline in LCS score, or death on study. LCS scores were obtained from a 7-item questionnaire from the FACT-L (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment. Analysis was performed using Kaplan-Meier method."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||months||95% Confidence Interval|Mean
1446119|NCT00883779|Secondary|Percentage of Participants With Symptomatic Progression Assessed Using the Lung Cancer Subscale (LCS)|"LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) (version 4.0). Participants responded to questions such as shortness of breath, cough, tightness in chest, breathing difficulty, appetite loss, weight loss and unclear thinking; on a 5-point scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, scores range on a scale of 0 (most symptomatic) to 28 (asymptomatic); higher score indicates fewer symptoms. A clinically meaningful decline used to determine symptomatic progression in this study was at least a three point decline in LCS score from baseline. Participants without symptomatic progression at the time of analysis were censored at the time of the last FACT-L assessment."|Baseline, Day 1 of Cycles 3 and 5, Day 1 of post-study Visits 1 and 2 until end of study medication administration or PD (up to approximately 1.5 years)|FAS population.|||percentage of participants|||Number
1446120|NCT00883779|Secondary|Time to Progression|Time to progression is defined as the time between the date of randomization and the date of the first documented disease progression. Participants who have not progressed at the time of study completion (or data cut off) or who were lost to follow up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was latest. PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. Participants with no post baseline tumor assessments were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD (assessed at baseline and every 8 weeks thereafter until PD or end of study [up to approximately 1.5 years])|FAS population.|||months||95% Confidence Interval|Median
1446121|NCT00883779|Secondary|Duration of Response|Duration of response is defined as the time between the date of first documented response (CR or PR, as determined by the RECIST criteria) and the date of first documented PD or death. Participants who did not progress or die after they had a confirmed response (CR or PR) were censored at the date of their last tumor assessment where non-progression was documented or last date of follow-up for progression of disease, whichever was last. CR and PR are defined in Outcome Measure 7.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population participants who were responders (CR or PR).|||months||95% Confidence Interval|Median
1446122|NCT00883779|Secondary|Objective Response Rate: Percentage of Participants With a Confirmed Best Overall Response of CR or PR|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||percentage of participants||95% Confidence Interval|Number
1446123|NCT00883779|Secondary|Non-Progression Rate: Percentage of Participants With a Confirmed Best Overall Response of Either Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for At Least 16 Weeks|Tumor response was evaluated according to RECIST (version 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the screening sum LD; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. Responses were confirmed with repeated assessment 4 weeks after initial response was observed.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||percentage of participants||95% Confidence Interval|Number
1446124|NCT00883779|Secondary|Percentage of Participants Alive at the End of Study-Overall and Among Different Subgroups||Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."|||percentage of participants|||Number
1446125|NCT00883779|Secondary|Median Overall Survival (OS) Time-Overall and Among Different Subgroups|OS was defined as the time between the date of randomization and the date of death from any cause. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Participants with no post baseline information were censored at the time of randomization. OS among different subgroups of type of carcinoma, smoking habit, EGFR mutation type, KRAS mutation type, EGFR IHC test result type, and EGFR FISH result type. Analysis was performed using Kaplan-Meier method.|Randomization until death (assessed at baseline and every 8 weeks thereafter until death or end of study [up to approximately 5.5 years])|"FAS population. n is the number of participants evaluable under the specified category."|||months||95% Confidence Interval|Median
1446126|NCT00883779|Secondary|Median PFS Time Based on Different Subgroups|Tumor response was evaluated according to RECIST (version 1.0). PD was defined in outcome measure 1. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. PFS among different subgroups of type of carcinoma, smoking habit, epidermal growth factor receptor (EGFR) mutation type, KRAS mutation type, EGFR immunohistochemistry (IHC) test result type, and EGFR fluorescent in situ hybridization (FISH) result type.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|"FAS population. n is the number of participants evaluable under the specified category."|||months||95% Confidence Interval|Median
1446127|NCT00883779|Secondary|Percentage of Participants Alive and Free From Disease Progression|Tumor response was evaluated according to RECIST (version 1.0). PD was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||percentage of participants|||Number
1446128|NCT00883779|Primary|Median Progression Free Survival (PFS) Time|Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.|Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years])|FAS population.|||months||95% Confidence Interval|Median
1446129|NCT00883753|Secondary|Change From Baseline in FACIT-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."|||score on a scale||Standard Deviation|Mean
1446684|NCT00879619|Secondary|Qualitative and Quantitative Toxicity|Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Categorical analysis of toxicities will be performed.|Every 3 weeks and at study termination|||||||
1446130|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36):Mental Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and at the given time-point."|||score on a scale||Standard Deviation|Mean
1446131|NCT00883753|Secondary|Change From Baseline in Quality of Life Short Form (SF-36): Physical Component Score|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
1446132|NCT00883753|Secondary|Percentage of Participants Achieving Health Assessment Questionnaire Disability Index (HAQ-DI) Clinical Remission|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinical Remission is defined as a HAQ-DI score < 0.5.|Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
1446133|NCT00883753|Secondary|Percentage of Participants Achieving Clinical Meaningful Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). Clinically meaningful improvement is defined as a reduction from Baseline in the HAQ-DI score ≥ 0.2.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
1446134|NCT00883753|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Response|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
1446135|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 90 (ACR90) Response|ACR90 response is defined as a ≥ 90 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
1446175|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 2)|NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Awakenings||Standard Error|Least Squares Mean
1446136|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 70 (ACR70) Response|ACR70 response is defined as a ≥ 70 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36 ,48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
1446137|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 50 (ACR50) Response|ACR50 response is defined as a ≥ 50 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
1446138|NCT00883753|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR20) Response|ACR20 response was defined as a ≥ 20 % improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||percentage of participants|||Number
1446139|NCT00883753|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."|||mg/dL||Standard Deviation|Mean
1446140|NCT00883753|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at Baseline and the given time-point."|||mm/hr||Standard Deviation|Mean
1446141|NCT00883753|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity VAS|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||mm||Standard Deviation|Mean
1446142|NCT00883753|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity VAS|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
1446685|NCT00879619|Secondary|Survival|Quantitative Kaplan-Meyer estimates of progression-free survival and overall survival will be determined.|At 2 and 3 years|||||||
1446143|NCT00883753|Secondary|Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||mm||Standard Deviation|Mean
1446144|NCT00883753|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||joint count||Standard Deviation|Mean
1446145|NCT00883753|Secondary|Change From Baseline in Tender Joint Count|68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||joint count||Standard Deviation|Mean
1446146|NCT00883753|Secondary|Change From Baseline in DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at both Baseline and the given time-point."|||score on a scale||Standard Deviation|Mean
1446147|NCT00883753|Secondary|Percentage of Participants With DAS28 Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission was defined as a DAS28 score < 2.6.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
1446148|NCT00883753|Secondary|Percentage of Participants With DAS28 Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Low Disease Activity was defined as a score of < 3.2.|Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"LTE ITT population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
1446149|NCT00883753|Secondary|Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Clinical meaningful improvement was defined as a ≥ 1.2 unit reduction in DAS28.|Core Baseline, Extension Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108|"Long Term Extension Intent-to-treat (LTE ITT) population included all participants from the Core Study who received at least one dose of study drug in the Extension Study. n in each of the categories is the number of participants with data available for both Baseline and the given time-point."|||percentage of participants|||Number
1446150|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Neutrophil Count During the Study|Blood samples were collected for a Neutrophil Count every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for Neutrophil Count during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.|||participants|||Number
1446151|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for Total Cholesterol During the Study|Blood samples were collected for Total Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by worst value for Total Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.|||participants|||Number
1446152|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for LDL Cholesterol During the Study|Blood samples were collected for LDL Cholesterol every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The number of participants categorized by the worst value for LDL Cholesterol during the study is reported: Low is below central lab reference range, Normal is within the central lab reference range and High is above central lab reference range.|108 Weeks|Participants from the LTE Safety population (all participants who received study drug and had at least one assessment of safety in the long term extension) with data available for analysis.|||participants|||Number
1446153|NCT00883753|Secondary|Number of Participants Categorized by Worst Value for AST (SGOT) During the Study|Blood samples were collected for liver function test: Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) [AST (SGOT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for AST=40 Units/Liter. The number of participants categorized by worst value for AST(SGOT) during the study is reported: Normal (AST result is within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.|||participants|||Number
1446154|NCT00883753|Secondary|Number of Participants Categorized by Highest Value for ALT (SGPT) During the Study|Blood samples were collected for liver function test: Alanine aminotransferase (serum glutamic-pyruvic transaminase) [ALT(SGPT)] every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. The Upper Limit of Normal (ULN) for ALT=55 Units/Liter. The number of participants categorized by the highest value for ALT/GPT during the study is reported: Normal (ALT result within the central lab reference range), Greater than the ULN to 1.5 times the ULN (>ULN to 1.5*ULN), 1.5 times the ULN to 3 times the ULN (1.5*ULN to 3*ULN) and 3 times the ULN to 5 times the ULN (3*ULN to 5*ULN).|108 Weeks|Participants from the LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE) with data available for analysis.|||participants|||Number
1446155|NCT00883753|Secondary|Percentage of Participants With AST Elevations > 3*ULN|Blood was collected for the Liver Function Test: Aspartate aminotransferase (AST) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 40 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
1446156|NCT00883753|Secondary|Percentage of Participants With ALT Elevations > 3*ULN|Blood samples were collected for the Liver Function Test: Alanine aminotransferase (ALT) every 12 weeks and at the follow-up visit in the Extension study and were sent to a central laboratory for analysis. Percentage of participants with any values greater than 3 times the Upper Limit of Normal (3*ULN) is reported. ULN= 55 Units/Liter.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
1446157|NCT00883753|Secondary|Percentage of Participants With Adverse Events (AEs) of Special Interest|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. Adverse Events of special interest for this study were: Infections (preferred term in the infection adverse event group term), Serious Infections (an infection that qualified as Serious Adverse Event), Infusion Reactions (occurred during infusion or within 24 hours of infusion), Major Cardiac AE (Myocardial Infarction/ Acute Coronary Syndrome), Stroke or Death.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
1446158|NCT00883753|Secondary|Percentage of Participants With Marked Lipid Abnormalities|Fasting blood samples were collected for Lipids: Cholesterol, Triglyceride, High-density lipoprotein (HDL) Cholesterol, Low-density lipoprotein (LDL) Cholesterol every 12 weeks and at follow-up in the Extension study and were sent to a central laboratory for analysis. Lipid abnormalities were defined as a High Cholesterol, High Triglyceride, Low HDL Cholesterol and a High LDL Cholesterol that occurred at any time in the extension study.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
1446159|NCT00883753|Secondary|Time to Discontinuation of Tocilizumab Treatment for Any Cause|Time in days from start of the Core Study Day 1 to discontinuation of tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE). Participants who did not experience discontinuation of tocilizumab treatment were censored.|||days||95% Confidence Interval|Median
1446160|NCT00883753|Secondary|Percentage of Participants With Discontinuation of Treatment Due to Any Cause|Percentage of participants who discontinued treatment with tocilizumab for any reason.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
1446161|NCT00883753|Secondary|Time to Withdrawal Due to an Adverse Event (AE)|Time to withdrawal was defined as the number of days from Core Study Day 1 to the first date of onset of the AE leading to discontinuation of tocilizumab.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension(LTE). Participants who did not experience an AE-related treatment discontinuation of tocilizumab were censored.|||days||95% Confidence Interval|Median
1446198|NCT00883337|Secondary|Extension Treatment Period: Overview of AEs|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|Safety population. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||participants|||Number
1446162|NCT00883753|Secondary|Percentage of Participants With Adverse Events Leading to Withdraw|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants|||Number
1446163|NCT00883753|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. The percentage of participants with AEs and SAEs that occurred in the Extension Study grouped according to the number of disease-modifying anti-rheumatic drugs (DMARD) a participant was taking at Core Baseline is presented.|108 Weeks|LTE Safety population included all participants who received study drug and had at least one assessment of safety in the long term extension (LTE).|||percentage of participants||95% Confidence Interval|Number
1446164|NCT00883740|Secondary|Subjective Total Sleep Time (sTST)|sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF|||Minutes||Standard Error|Least Squares Mean
1446165|NCT00883740|Secondary|Subjective Wake After Sleep Onset (sWASO)|sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant’s daily SSQ values.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF|||Minutes||Standard Error|Least Squares Mean
1446166|NCT00883740|Secondary|Daily Pain Score|Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores.|Daily up to Day 73 or ET|ITT; LOCF|||Units on a scale||Standard Error|Least Squares Mean
1446167|NCT00883740|Secondary|Latency of Sleep Onset (LSO)|LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant’s daily SSQ.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; LOCF|||Minutes||Standard Error|Least Squares Mean
1446168|NCT00883740|Secondary|Sleep Quality|Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores.|Weeks 1, 2, 3 and 4 of Each Intervention Period or ET|ITT; Last observation carried forward (LOCF)|||Unit on a scale||Standard Error|Least Squares Mean
1446169|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT|||Units on a scale||Standard Error|Least Squares Mean
1446170|NCT00883740|Secondary|Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11|MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline.|Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET|ITT; n: number of participants at specific time points|||Units on a scale||Standard Error|Least Squares Mean
1446171|NCT00883740|Secondary|Slow Wave Sleep (SWS)|SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Percentage of total sleep time||Standard Error|Least Squares Mean
1446172|NCT00883740|Secondary|WASO by Each Quarter of the Night|WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
1446173|NCT00883740|Secondary|WASO by Hour of the Night|WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total).|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
1446174|NCT00883740|Secondary|Latency to Persistent Sleep (LPS)|LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
1446176|NCT00883740|Secondary|Number of Awakenings After Sleep Onset (NAASO 1)|NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Awakenings||Standard Error|Least Squares Mean
1446177|NCT00883740|Secondary|Sleep Efficiency (SE)|SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Percentage of time asleep||Standard Error|Least Squares Mean
1446178|NCT00883740|Secondary|Total Sleep Time (TST)|TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
1446179|NCT00883740|Secondary|Wake Time After Sleep (WTAS)|WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|ITT|||Minutes||Standard Error|Least Squares Mean
1446180|NCT00883740|Secondary|Wake Time During Sleep (WTDS)|WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET|Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation|||Minutes||Standard Error|Least Squares Mean
1446181|NCT00883740|Primary|Wake After Sleep Onset (WASO) at Weeks 5 and 11|WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]) on 2 consecutive nights divided by 2 at the end of each intervention period.|Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)|Per Protocol Population (PP) = all randomized participants who received study medication at a dose of 300 or 450 mg/day and completed the study without any major protocol violations;|||Minutes||Standard Error|Least Squares Mean
1446182|NCT00883675|Primary|Febrile Neutropenia|The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%.|2 months|Intent to treat|||participants|||Number
1446183|NCT00883558|Secondary|Number of Participants With Hypoglycemic Events|The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 29|Participants who received at least 1 dose of study drug.|||participants|||Number
1446184|NCT00883558|Secondary|Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring|Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.|Week 14 and Week 26|Participants that completed both treatment cycles with evaluable CGM data.|||hours||Standard Deviation|Mean
1446185|NCT00883558|Primary|Postprandial Glucose Excursion|A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.|Week 14 and Week 26|Participants who completed both treatment cycles with evaluable postprandial glucose data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1446186|NCT00883493|Secondary|Treatment Satisfaction Questionnaire (TSQ) Scores.|"The 14-item TAQ questionnaire evaluates the patient’s overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.~Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||Scores on a scale||Standard Deviation|Mean
1446187|NCT00883493|Secondary|Change in the Sheehan Disability Scale (SDS) Total Score.|"The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).~Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||scores on a scale||95% Confidence Interval|Mean
1446211|NCT00883246|Secondary|Rutherford Clinical Category (in All Patients Enrolled)|Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.|1 Year|All patients with RCC data at baseline and 1 year|||percentage of patients|||Number
1446188|NCT00883493|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.|"The mean change in (Q-LES-Q–Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).~The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life."|baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||scores on a scale||Standard Deviation|Mean
1446189|NCT00883493|Secondary|Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.|"The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.~PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality."|Baseline, 8 weeks|The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.|||Scores on a scale||95% Confidence Interval|Mean
1446190|NCT00883493|Secondary|Change in Young Mania Rating Scale (YMRS) Total Score.|"The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient’s subjective report of his or hers clinical condition over the previous 48 hours.~The mean change in YMRS Total score reported was calculated as baseline - week 8.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).|||scores on a scale||Standard Deviation|Mean
1446191|NCT00883493|Secondary|Change in the Clinical Global Impression Severity (CGI-S) Score.|"The reported mean change in the CGI-S score was calculated as baseline - week 8.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill."|baseline, 8 weeks|The analysis population was “Per Protocol” (PP).|||scores on a scale||Standard Deviation|Mean
1446192|NCT00883493|Secondary|Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score|"The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).~The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as “anxious mood”, “tension” or “fears”. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max)."|baseline, 8 weeks|"The analysis population was Per Protocol (PP)."|||scores on a scale||Standard Deviation|Mean
1446193|NCT00883493|Secondary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|"The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).~HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression."|Baseline, 8 Weeks|"The analysis population was Per Protocol (PP)."|||scores on a scale||Standard Deviation|Mean
1446194|NCT00883493|Secondary|Response Rate for MADRS.|"Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|baseline, week 8|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.|||percentage of participants|||Number
1446195|NCT00883493|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.|"The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks).~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 8 weeks|The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.|||scores on a scale||Standard Deviation|Mean
1446196|NCT00883389|Primary|Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device.|"Qualitative questionnaire with primary assessment: How useful do you think the Med-alert device will be for future healthcare. Response recorded based on a Likert scale with response of 0 = not useful, 1 = somewhat useful, 2 = extremely useful"|3 months||||Likert scale||Inter-Quartile Range|Median
1446197|NCT00883337|Secondary|Extension Treatment Period: ARR Poisson Regression Estimates|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of the standardized treatment durations.To account for the different treatment durations among participants, a Poisson Regression Model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 197 weeks)|ITT population.|||relapses per year||95% Confidence Interval|Number
1446199|NCT00883337|Secondary|Core Treatment Period: Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"Safety population: all randomized and treated participants. Participants were considered according to the drug actually received.~The participant randomized to Teriflunomide 14 mg group who received Teriflunomide 7 mg was analyzed in the Teriflunomide 7 mg group."|||participants|||Number
1446200|NCT00883337|Secondary|Core Treatment Period: Treatment Satisfaction Questionnaire for Medication [TSQM] Scores|TSQM version 1.4 is an instrument to assess patients' satisfaction with medication. It consists of 13 questions that cover three dimensions (effectiveness, side effects and convenience) plus a global satisfaction question. Four scores ranging from 0 to 100 (extremely satisfied) are obtained. Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on TSQM score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction as factors).|48 weeks|ITT population.|||units on a scale||Standard Error|Least Squares Mean
1446201|NCT00883337|Secondary|Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score|"FIS is a subject-reported scale that qualifies the impact of fatigue on daily life in patients with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors)."|Baseline (before randomization) and 48 weeks|ITT population.|||units on a scale||Standard Error|Least Squares Mean
1446202|NCT00883337|Secondary|Core Treatment Period: Annualized Relapse Rate [ARR] - Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.|||relapses per year||95% Confidence Interval|Number
1446203|NCT00883337|Primary|Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints|"Probability of disability progression at 24, 48 and 96 weeks was estimated using Kaplan-Meier method on the time to failure defined as the time from randomization to failure. Participants free of failure were censored at the date of last treatment.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|ITT population.|||percent probability||95% Confidence Interval|Number
1446204|NCT00883337|Primary|Core Treatment Period: Overview of Failures|"Failure was defined as the first occurence of confirmed relapse or permanent treatment discontinuation (for any cause) which ever came first. If no events occurred, the participant was considered free of failure.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores."|Core treatment period between 48 and 118 weeks depending on when the participant was enrolled|Intent-to-treat population: all randomized participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||participants|||Number
1446205|NCT00883246|Secondary|Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)|Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.|1 year|Lesions in patients with claudication at baseline|||percentage of lesions|Participants||Number
1446206|NCT00883246|Secondary|Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)|Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.|3 months|Patients with wounds at baseline who had wound assessment scores at baseline and at 3 months.|||percentage of patients|||Number
1446207|NCT00883246|Secondary|Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)|Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.|One Year|All claudicants.|||percentage of patients|||Number
1446208|NCT00883246|Secondary|Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment|One Year|All patients with CLI.|||percentage of lesions|Participants||Number
1446209|NCT00883246|Secondary|Secondary Patency (in Patients Treated for Claudication RCC 1-3)|Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.|One Year|All claudicants.|||percentage of lesions|Participants||Number
1446210|NCT00883246|Secondary|Ankle-Brachial Index (in All Patients Enrolled)|Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9 was calculated.|1 Year|All patients with compressible arteries and a baseline ABI < 0.9.|||percentage of patients|||Number
1446212|NCT00883246|Secondary|Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)|WIQ Walking Distance Scores at Baseline and One Year are presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.|Baseline and 1 Year|All subjects treated for claudication RCC 1-3 with completed WIQ forms|||units on a scale||Standard Deviation|Mean
1446213|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).|One Year||||percentage of patients|||Number
1446214|NCT00883246|Secondary|Major Adverse Event Rate (in All Patients Enrolled)|Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).|30 Days||||percentage of patients|||Number
1446215|NCT00883246|Secondary|Procedural Success (in All Patients Enrolled)|Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography|Immediately following use of the SilverHawk and adjunctive devices|All lesions with angiographic core lab assessment of residual stenosis at the end of the procedure were included|||percentage of lesions|Participants||Number
1446216|NCT00883246|Secondary|Device Success (in All Patients Enrolled)|Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions.|Immediately following use of the SilverHawk device|Lesions with core angiographic laboratory measurements of residual stenosis|||percentage of Lesions|Participants||Number
1446217|NCT00883246|Primary|Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)|The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 – 6) at time of enrollment.|One Year||||percentage of subjects|||Number
1446218|NCT00883246|Primary|Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)|The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 – 3) at time of enrollment.|One year|Kaplan-Meier estimate of the freedom from loss of primary patency in lesions (N=743 lesions)|||percentage of lesions|Participants||Number
1446219|NCT00883233|Primary|Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.|Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit.|Week 4||||Scores on a scale||Standard Deviation|Mean
1446220|NCT00883181|Secondary|Number of Transfusions Per Participant in Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
1446221|NCT00883181|Secondary|Number of Participants With Systemic Transfusions in Cycles 1 to 8|Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
1446222|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment|The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.|9 weeks post initiation of ESA treatment|Participants who received treatment with an ESA|||percentage of participants||95% Confidence Interval|Number
1446223|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
1446224|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
1446225|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 12 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
1446287|NCT00883090|Primary|Clearance||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||mL/hr/kg||Standard Deviation|Mean
1446226|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 11 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
1446227|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA, and with hemoglobin < 10 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
1446228|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment|Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin < 9 g/dL at initiation of ESA treatment and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
1446229|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response|Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||percentage of participants||95% Confidence Interval|Number
1446230|NCT00883181|Secondary|Change in Hemoglobin During ESA Treatment Phase||Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.|Participants who received treatment with an ESA and with hemoglobin measurements available at both time points.|||g/dL||Standard Deviation|Mean
1446231|NCT00883181|Secondary|Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment|Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.|From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.|Participants who received treatment with an ESA and still on study 5 weeks after initiation of ESA treatment.|||percentage of participants||95% Confidence Interval|Number
1446232|NCT00883181|Secondary|Number of Clinical Visits in Cycles 1-8 by ESA Use|The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||visits per month||Standard Deviation|Mean
1446233|NCT00883181|Secondary|Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||participants|||Number
1446234|NCT00883181|Secondary|Reason for Treatment With Erythropoiesis-stimulating Agents|The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.|Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||participants|||Number
1446235|NCT00883181|Secondary|Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)||Cycles 1 - 8 (approximately 24 weeks)|Participants who received treatment with an ESA|||weeks||Standard Deviation|Mean
1446236|NCT00883181|Secondary|Time to Disease Progression|Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.|From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.|Full analysis set|||months||95% Confidence Interval|Median
1446237|NCT00883181|Secondary|Number of Participants With Hematological Toxicities|The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
1446238|NCT00883181|Secondary|Investigator Assessed Clinical Response at End of Treatment||End of treatment (approximately 24 weeks)|Full analysis set|||participants|||Number
1446239|NCT00883181|Secondary|Number of Participants With Unplanned Hospitalizations|Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
1446240|NCT00883181|Secondary|Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8|Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
1446241|NCT00883181|Secondary|Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned and with ≥ 15% chemotherapy dose reduction in any cycle.|||cycles|Cycles with ≥ 15% dose reduction||Number
1446242|NCT00883181|Secondary|Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy and had > 3 days delay in one or more cycles|||cycles|Cycles with > 3 days delay||Number
1446243|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Reductions|A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)|||percentage of cycles|Total cycles||Number
1446244|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Reductions|A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants with actual regimens as planned (17 participants received a different regimen to what was planned and are thus excluded)|||percentage of participants||95% Confidence Interval|Number
1446245|NCT00883181|Secondary|Percentage of Cycles With Chemotherapy Dose Delays|A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 days)|Full analysis set participants who received more than 1 cycle of chemotherapy|||percentage of cycles|Total cycles||Number
1446246|NCT00883181|Secondary|Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8|A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.|Cycles 2 - 8 (approximately 21 weeks)|Full analysis set participants who received more than 1 cycle of chemotherapy|||percentage of participants||95% Confidence Interval|Number
1446247|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF|||days||Standard Deviation|Mean
1446248|NCT00883181|Secondary|Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim|||days||Standard Deviation|Mean
1446249|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any other G-CSF|||percentage of participants||95% Confidence Interval|Number
1446250|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with any daily G-CSF|||percentage of participants||95% Confidence Interval|Number
1446251|NCT00883181|Primary|Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received treatment with pegfilgrastim|||percentage of participants||95% Confidence Interval|Number
1446252|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with other G-CSF|||percentage of participants||95% Confidence Interval|Number
1446288|NCT00883090|Primary|Area Under the Curve at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units*hr/mL||Standard Deviation|Mean
1446253|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with other G-CSF|||percentage of participants||95% Confidence Interval|Number
1446254|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF.|||days||Standard Deviation|Mean
1446255|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim|||days||Standard Deviation|Mean
1446256|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF|The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF|||days||Standard Deviation|Mean
1446257|NCT00883181|Secondary|Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim|The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim|||days||Standard Deviation|Mean
1446258|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with any daily G-CSF|||percentage of participants||95% Confidence Interval|Number
1446259|NCT00883181|Primary|Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received secondary prophylaxis with pegfilgrastim|||percentage of participants||95% Confidence Interval|Number
1446260|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with any daily G-CSF|||percentage of participants||95% Confidence Interval|Number
1446261|NCT00883181|Primary|Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the ‘best’ G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received primary prophylaxis with pegfilgrastim|||percentage of participants||95% Confidence Interval|Number
1448686|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 1|Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg|baseline, week 1|FAS (LOCF)|||participants|||Number
1446262|NCT00883181|Primary|Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia|FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set participants who received no prophylaxis or treatment with any G-CSF|||percentage of participants||95% Confidence Interval|Number
1446263|NCT00883181|Secondary|Number of Participants Who Received G-CSF During Cycles 1 to 8||Cycles 1 - 8 (approximately 24 weeks)|Full analysis set|||participants|||Number
1446264|NCT00883181|Primary|Percentage of Participants With Febrile Neutropenia (FN)|Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm².|Cycles 1 - 8 (approximately 24 weeks)|Full analysis set; Note: One participant with breast cancer had disease stage missing.|||percentage of participants||95% Confidence Interval|Number
1446265|NCT00883168|Secondary|Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to treat (ITT)population includes all subjects(18 years or older) who had at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
1446266|NCT00883168|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|change from baseline in 12-hour instantaneous total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improved condition.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who received at least one post baseline efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
1446267|NCT00883168|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population includes all subjects who had at least one post baseline dose efficacy evaluation|||units on a scale||Standard Deviation|Least Squares Mean
1446268|NCT00883129|Secondary|Tolerability, as Assessed by the Time to Withdrawal From the Study Drug or Meeting Protocol-defined Criteria for Treatment Failure.|The number of participants who remained in the study at the listed time points are reported|Continuous assessment from randomization to 24 months||||Participants|||Count of Participants
1446269|NCT00883129|Secondary|Toxicity, as Measured by Adverse Events, Serious Adverse Events, and Death||Measured throughout the 2-year study||||Participants|||Count of Participants
1446270|NCT00883129|Secondary|Skin Involvement, as Measured by the Modified Rodnam Skin Thickness Scores (mRSS)|Skin thickness is quantified using the modified Rodnan measurement method (mRSS), with a scale that ranges from 0 (no skin involvement) to a maximum of 51. The reported skin score is determined by a clinical assessment of skin thickness, which is performed by a trained reader, and represents the sum of individual assessments that are made in each of 17 body areas. Each area is given a score in the range of 0-3 (0 = normal; 1= mild thickness; 2 = moderate; 3 = severe thickness). A higher score represents more severe skin involvement.|Measured at baseline and Months 3, 6, 9, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||mRSS score||95% Confidence Interval|Mean
1446271|NCT00883129|Secondary|Health-related Quality of Life as Measured by the Patient Responses to the Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI asks questions related to 8 activity domains (dressing, arising, eating, walking, hygiene, reach, grip, and common daily activities) with the patient's capacity to carry out each activity scored from 0 to 3. Scores across all domains are averaged and a higher score represents greater disability.|Measured at study entry and Months 3, 6, 9, 12, 15, 18, 21, and 24|The analysis population contains all of those with data available at the defined time point.|||HAQ-DI Total Score||Standard Deviation|Mean
1446272|NCT00883129|Secondary|Transitional Dyspnea Index Score|Change in breathlessness was assessed using the Transitional Dyspnea Index, which compares current symptoms to those at baseline. Total score ranges from - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea.|Measured at Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||Transitional Dyspnea Index Score||95% Confidence Interval|Mean
1446273|NCT00883129|Secondary|Fibrosis Score, as Measured by Thoracic High Resolution Computerized Tomography (HRCT)|Imaging of the whole lung (WL) is performed using a volumetric high resolution computerized tomography (HRCT) scan, which is then analyzed using a computer algorithm to determine the percentage of overall pixels exhibiting features characteristic for quantitative lung fibrosis (QLF). Higher percentages for QLF-WL therefore represent greater involvement by lung fibrosis.|Measured at baseline and Month 24|Analysis was carried out in the subset of subjects that had measurable HRCT scans at both study entry and 24 months|||% of lung exhibiting QLF||95% Confidence Interval|Mean
1446274|NCT00883129|Secondary|Single-breath Diffusing Capacity for Carbon Monoxide (DLCO), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||DLCO %-pred||95% Confidence Interval|Mean
1446275|NCT00883129|Secondary|Total Lung Capacity (TLC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The TLC represents the total volume of air within the lung after taking the deepest breath possible and the TLC %-predicted represents the TLC expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The TLC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.|Measured at study entry and Months 6, 12, 18, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||TLC %-pred||95% Confidence Interval|Mean
1446276|NCT00883129|Primary|Forced Vital Capacity (FVC), as a Percent of the Age, Height, Gender, and Ethnicity Adjusted Predicted Value|The primary outcome is the course over time from baseline to 24 months for the FVC %-predicted. The FVC %-predicted represents the adjusted volume of air (adjusted as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity) that can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC %-predicted is reduced in patients with interstitial lung disease and is used as a measure of lung involvement and disease severity.|Measured at study Baseline and Months 3, 6, 12, 15, 18, 21, and 24|Randomized participants with an acceptable baseline HRCT study (a pre-specified covariate) and at least one outcome measure|||FVC %-pred||95% Confidence Interval|Mean
1446277|NCT00883116|Secondary|Number of Participants With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From Day 1 (first dose) to 30 days past last dose (up to Day 219); 9 cycles, or 189 days + 30 days|All participants who received at least 1 dose of ixabepilone|||Participants|||Number
1446278|NCT00883116|Secondary|Best Overall Response Rate|Best overall response rate was defined as the number of participants whose best response was either partial response (PR) or complete response (CR) divided by the number of participants in the treatment group. Overall tumor response was based on an integration of the evaluation of target, nontarget, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions; taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met.|Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)|All randomized participants with measurable disease|||Percentage of participants||95% Confidence Interval|Number
1446279|NCT00883116|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the date of documented disease progression. Patients who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Participants who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the patient had 1 or more measurable lesions.|Date of randomization to date of disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months|All participants with measurable disease at randomization|||Months||95% Confidence Interval|Median
1446280|NCT00883116|Primary|Overall Survival (OS)|Survival was defined as the time from the date of randomization until the date of death. If the patient did not die, OS was censored on the last date he or she was known to be alive.|Date of randomization to date of death or last date censored to up to approximately 26 months|All randomized participants|||Months||95% Confidence Interval|Median
1446281|NCT00883103|Primary|Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain|A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.|Immediately after the examination|All participants assigned to the lidocaine or aqueous gel groups were analyzed. There was no dropout or missing information.|||Scores on a scale||Full Range|Median
1446282|NCT00883090|Secondary|Vital Signs|Number of participants with clinically significant vital signs. The vital signs measured included blood pressure, pulse rate and temperature. Clinically significant changes in vital signs were to be reported as adverse events.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.|||participants|||Number
1446283|NCT00883090|Secondary|Laboratory Safety Parameters|Number of participants with clinically significant laboratory safety parameter values. The laboratory safety parameters measured included serum chemistries, hematology and urinalysis.|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.|||participants|||Number
1446284|NCT00883090|Secondary|Adverse Events|Number of participants with an adverse event|16 weeks|The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.|||participants|||Number
1446285|NCT00883090|Primary|Mean Residence Time||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||days||Standard Deviation|Mean
1446286|NCT00883090|Primary|Volume of Distribution at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||mL/kg||Standard Deviation|Mean
1446290|NCT00883090|Primary|Incremental Recovery|Incremental recovery (U/mL/U/kg) is defined as the maximum (peak) FXIII activity (U/mL) obtained after infusion, per dose of FXIII (U/kg) administered.|12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units/mL/Units/kg||Standard Deviation|Mean
1446291|NCT00883090|Primary|Time to Peak Concentration||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||hr||Standard Deviation|Mean
1446292|NCT00883090|Primary|Trough FXIII Concentration at Steady State||12 weeks|The analysis population was the PK population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units/mL||Standard Deviation|Mean
1446293|NCT00883090|Primary|Peak FXIII Concentration at Steady State||12 weeks|The analysis population was the pharmacokinetic (PK) population. The PK population comprised all subjects in the safety population who completed the study (defined as having sufficient bioanalytical assessments to calculate reliable estimates of the PK parameters specified).|||Units/mL||Standard Deviation|Mean
1446294|NCT00882921|Secondary|Change From Baseline in uGAG Levels to 109 Weeks|Urine GAG|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase. The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.|||mcg/mg||Standard Deviation|Mean
1446295|NCT00882921|Primary|Infusion-Related Adverse Event (IRAE) Rates Between IgG Anti-idursulfase Antibody Positive (Ab+) and Anti-idursulfase IgG Antibody Negative (Ab-) Patients|The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.|Baseline to 109 Weeks|The Safety Population was defined as all enrolled patients who received any portion of a dose of Elaprase.|||IRAE/Week|||Number
1446296|NCT00882908|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435|The table below shows the median (range) AUC24h values for TMC435 for participants in each of the 4 TMC435 treatment groups. Two blood samples taken at least 2 hours apart from each other for determination of TMC435 plasma pharmacokinetics were obtained in all participants on Weeks 2, 4, 8, 12, 16, and 24 to obtain Bayesian estimates of TMC435 AUC24h (overall exposure).|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng*h/mL||Full Range|Median
1446297|NCT00882908|Secondary|Plasma Concentrations of TMC435|The table below shows median (range) predose plasma concentration (C0h) values and median (range) average steady-state plasma concentration (Css,av) values for participants in each of the 4 TMC435 treatment groups.|Two random blood samples taken at least 2 hours apart at Weeks 2, 4, 8, 12, 16, and 24|Participants who received at least 1 dose of study medication with at least 1 post-baseline pharmacokinetic (PK) assessment were included in the PK analysis population.|||ng/mL||Full Range|Median
1446298|NCT00882908|Secondary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)|The table below shows the number of participants with abnormal ALT levels at Baseline who achieved ALT levels within the normal range at the EOT.|Baseline (Day 1) up to Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Participants|||Number
1446299|NCT00882908|Secondary|The Number of Participants With Viral Relapse|The table below shows the number of participants who experienced viral relapse, defined as a confirmed detectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level during the follow-up period in participants with undetectable plasma HCV RNA (less than 25 IU/mL undetectable) at the end of treatment.|Up to Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Participants|||Number
1446300|NCT00882908|Secondary|Number of Participants With Viral Breakthrough|The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period of the study, defined as a confirmed increase of more than 1 log10 IU/mL in plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA more than 100 IU/mL in participants whose plasma HCV RNA level had previously been below the limit of quantification (less than 25 IU/mL detectable or undetectable).|Week 24 or 48|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Participants|||Number
1446301|NCT00882908|Secondary|The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|The table below shows the percentage of participants who achieved undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 12 Weeks after the EOT.|Up to Week 36 or 52|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446302|NCT00882908|Secondary|The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)|The table below shows the percentage of participants in each treatment group who had a cEVR, defined as having undetectable plasma Hepatitis C Virus ribonucleic acid levels at Week 12.|Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446303|NCT00882908|Secondary|The Percentage of Participants Achieving an Early Virologic Response (EVR)|The table below shows the percentage of participants who achieved an EVR, defined as having a change from baseline in plasma Hepatitis C virus ribonucleic acid of 2 log10 at Week 12.|Baseline (Day 1) and Week 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446304|NCT00882908|Secondary|The Percentage of Participants Achieving a Rapid Virologic Response (RVR)|The table below shows the percentage of participants in each treatment group who achieved a RVR, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels after receiving 4 weeks of treatment.|Week 4|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446305|NCT00882908|Secondary|The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|The table below shows the percentage of participants in each treatment group who achieved a SVR24, defined as having undetectable plasma Hepatitis C virus ribonucleic acid levels at the end of treatment (EOT) and 24 weeks after the EOT.|Week 48 or 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446306|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA greater than or equal to 2 log10 drop from Baseline at selected time points during treatment.|Baseline (Day 1) and Weeks, 2, 4, 8, and 12|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446307|NCT00882908|Secondary|The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma levels of HCV RNA less than 25 IU/mL detectable or undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446308|NCT00882908|Secondary|The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up|The table below shows the percentage of participants in each treatment group who achieved plasma HCV RNA levels of less than 25 IU/mL undetectable at selected time points during treatment, follow-up, and at end of treatment (EOT).|Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446309|NCT00882908|Primary|The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)|The table below shows the percentage of participants in each treatment group who achieved a SVRW72, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72.|Week 72|The intent-to treat population (defined as those participants who received at least 1 dose of study medication) was used for all efficacy and safety analyses.|||Percentage of participants|||Number
1446310|NCT00882778|Secondary|Number of Physician Reported Outcome Assessment in Prophylaxis in Percentage of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days|||percentage of patients|||Number
1446311|NCT00882778|Secondary|Physician Reported Outcome Assessment in Prophylaxis in Number of Patients|Physician's assessment of prophylaxis outcome as successful, partially successful, unsuccessful, or unable to determine|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days|||patients|||Number
1446312|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months.|||change in days per month||Standard Deviation|Mean
1446313|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis of approximately 6 months.|||change in days per month||Standard Deviation|Mean
1446314|NCT00882778|Secondary|Healthcare Resource Consumption of Total Hospital Length of Stay and School/Work Absences Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of total hospital length of stay and school/work absences during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (RFVIIa) for at least 30 days.|||change in days per month||Standard Deviation|Mean
1446315|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Frequent Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||change in events per month||Standard Deviation|Mean
1446316|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations and Hospital Admissions Per Month - Bleeding Population|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis period to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||change in events per month||Standard Deviation|Mean
1446317|NCT00882778|Secondary|Healthcare Resource Consumption of Visits, Consultations, and Hospital Admissions Per Month - All Patients|Healthcare resource consumption evaluated the absolute change in number of outpatient clinical visits, physician consultations and hospital admissions during the pre-prophylaxis to the prophylaxis period.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Whole population of all male patients diagnosed with haemophilia A or B with inhibitor, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days|||change in events per month||Standard Deviation|Mean
1446318|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Frequent Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (= 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected in these patients. Bleed episodes with no recorded locations were not included in the analysis|||percent change (%) in bleeds per month|||Number
1446319|NCT00882778|Secondary|Total Bleed Episodes Per Month by Joint, Target Joint and Non-joint - Bleeding Population|Percent change in bleed episodes per month between pre-prophylaxis period and prophylaxis period by location of joint, target joint (defined as 3 or more documented bleeds in the same joint over the course of 6 months) or non-joint. All joints = target joints and non-target joints.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approx. 6 months. Patients from the French sites were not included because bleed location was not collected. Bleed episodes with no recorded locations were not included in the analysis|||percent change (%) in bleeds per month|||Number
1446320|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
1446321|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
1446322|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Frequent Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
1446323|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adult|Individual activated recombinant human factor VII dose for adult patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
1446721|NCT00879229|Secondary|Long-term Survival|Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.|Week 48|Full Analysis Set|||percent probability (KM% estimate)||95% Confidence Interval|Number
1446324|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Adolescent|Individual activated recombinant human factor VII dose for adolescent patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
1446325|NCT00882778|Secondary|Individual Dose by Dose Regimen and Age Group - Bleeding Population, Paediatric|Individual activated recombinant human factor VII dose for paediatric patients by dosing regimen (infrequent dosing = less than 2 doses per week, three times per week = dosing 2-4 times per week, daily = 5-7 doses per week, or frequent dosing = 7 or more doses per week).|Data was collected for the period of prophylactic treatment (prophylaxis period), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||mcg/kg||Full Range|Median
1446326|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446327|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446328|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446329|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Frequent Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446330|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Frequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Frequent dosing was defined as 7 or more doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446331|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Daily Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Daily dosing was defined as 5 to 7 doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446332|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Dosing Three Times Per Week|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Three times per week dosing was defined as dosing two to four times per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446333|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month by Dosing and Age Categories - Bleeding Population, Infrequent Dosing|Percent change of bleeds per month between the pre-prophylaxis period and prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years. Infrequent dosing was defined as less than two doses per week. All participants = paediatrics, adolescents and adults.|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446334|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Frequent Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446335|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month Per Age Categories - Bleeding Population|Percent change of bleeds per month between the pre-prophylaxis period and the prophylaxis period. Paediatric patients below 12 years, adolescents 12-17 years, and adults at least 18 years|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446336|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Frequent Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Frequent bleeding population is a subset of patients in the bleeding population with at least one bleed per month in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446337|NCT00882778|Primary|Percent Change in Total Bleed Episodes Per Month - Bleeding Population|Percent change of bleeds per month in the pre-prophylaxis period and bleeds per month in the prophylaxis period|Data was collected for an average of 6 months prior to start of prophylaxis (pre-prophylaxis period) and the period of prophylactic treatment (during prophylaxis), which had no time frame limits. Participants were on prophylaxis for a median of 288 days.|Bleeding population with at least one bleed in the pre-prophylaxis period of approximately 6 months|||percent change (%) in bleeds per month|||Number
1446338|NCT00882713|Secondary|Mean Change From Baseline in Weight Over Time|Mean change in weight was defined as the difference between mean weight at Baseline and following visits (Week 16 and Week 48).|Week 16 and Week 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.|||kilogram||Standard Deviation|Mean
1446339|NCT00882713|Secondary|Mean Change From Baseline in Blood Pressure Over Time|Mean change in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) before and after dialysis was defined as the difference between mean blood pressure at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.|||millimeter of mercury||Standard Deviation|Mean
1446340|NCT00882713|Secondary|Mean Change From Baseline in Pulse Rate Over Time|Mean change in pulse rate was defined as the difference between mean pulse rate at Baseline and following visits (Weeks 8, 16, 24, 32, 40, and 48).|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Participants with available data at the time of evaluation were analyzed. Number of participants with available data at specified period is denoted by ‘n’.|||beats per minute||Standard Deviation|Mean
1446341|NCT00882713|Secondary|Mean Transferrin Saturation Levels Over Time|The mean transferrin saturation (TSAT) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||Percentage of Transferrin Saturation||Standard Deviation|Mean
1446342|NCT00882713|Secondary|Mean Ferritin Levels Over Time|The mean ferritin levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||mcg/L||Standard Deviation|Mean
1446343|NCT00882713|Secondary|Mean C-Reactive Protein Levels Over Time|The mean C-Reactive Protein (CRP) Levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||miligrams/L||Standard Deviation|Mean
1446344|NCT00882713|Secondary|Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time|The mean creatinine, iron, and total iron binding capacity (TIBC) levels over time were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||micromole/L||Standard Deviation|Mean
1446345|NCT00882713|Secondary|Mean Phosphate and Potassium Levels Over Time|The phosphate and potassium levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||milimole/L||Standard Deviation|Mean
1446346|NCT00882713|Secondary|Mean White Blood Cells and Thrombocytes Over Time|The white blood cells (WBCs) and thrombocyte levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||10^9 cells/L||Standard Deviation|Mean
1446347|NCT00882713|Secondary|Mean Albumin Levels Over Time|The albumin levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and a safety follow-up, whether withdrawn prematurely or not. Out of 194, one participant was excluded from the ITT population due to missing hemoglobin measurement and C.E.R.A medication after Week 0.|||g/L||Standard Deviation|Mean
1446348|NCT00882713|Secondary|Mean Hematocrit Levels Over Time|The hematocrit (HCT) levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||Proportion of red blood cells in blood||Standard Deviation|Mean
1446349|NCT00882713|Secondary|Mean Hemoglobin Levels Over Time|The Hb levels were recorded for each participant at enrolment and at different time points during the study up to Week 48.|Baseline (Week 0) and Weeks 8, 16, 24, 32, 40, and 48|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not. Number of participants with available data at specified period is denoted by ‘n’.|||g/dL||Standard Deviation|Mean
1446350|NCT00882713|Secondary|Incidences of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase|Red Blood Cells (RBCs) transfusions were given during the treatment period in case of medical need. Blood transfusions occurred during the DTP, EEP, and during the long term safety period (LTSP) were reported.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.|||Number of RBCs transfusion|||Number
1446351|NCT00882713|Secondary|Percentage of Participants Requiring Any Dose Adjustment During DTP and EEP|Percentage of participants requiring any dose adjustment during DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24) is reported. The dose adjustments (increase or decrease) were required: if a single Hb concentration was either > or = 13 g/dL or < or = 9 g/dL; if the difference of 2 consecutive Hb concentrations was > or =2 g/dL; if the values of scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of range of 10.5 to 11.5 g/dL, the difference between the reference value (mean of Hb concentrations based on the Hb assessments at Weeks -4, -3, -2, -1, and 0) and the most recent value was >1 g/dL; if the values of the scheduled Hb assessments on the day of administration of C.E.R.A. and on the previous study visit were both out of the range 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP (Week 1 to Week 16) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||Percentage of participants|||Number
1446352|NCT00882713|Secondary|Number of Participants With Any Adverse Events or Serious Adverse Events|An adverse event (AE) is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAEs) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, and congenital anomaly.|Up to Week 52|Safety population included all participants who have been treated with at least one dose of the study drug and completed a safety follow-up, whether withdrawn prematurely or not.|||Participants|||Number
1446353|NCT00882713|Secondary|Mean Time Spent By Participants With Hemoglobin Range of 10.5-12.5 g/dL During the EEP|Mean time spent by participants in Hb range of 10.5-12.5 g/dL during the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||Days||Standard Deviation|Mean
1446354|NCT00882713|Secondary|Percentage of Participants Maintaining Hemoglobin Concentration Within the Range of 10.5-12.5 g/dL Throughout the EEP|Percentage of participants maintaining Hb concentration within the range of 10.5-12.5 g/dL throughout the EEP is reported. The EEP was from Week 17 to Week 24.|EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||Percentage of participants||95% Confidence Interval|Number
1446355|NCT00882713|Secondary|Mean Change in Hemoglobin Concentration Between Reference (Stability Verification Period) and the Efficacy Evaluation Period|Mean change in Hb concentration between reference SVP and the EEP is reported. The SVP was at Weeks -3, -2, -1, and EEP was from Week 17 to Week 24. Participants received epoetin alfa or beta during SVP.|SVP (Weeks -3, -2, -1) and EEP (Week 17 to Week 24)|ITT population included all the participants who had received at least one dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable (laboratory data, adverse events, etc.) was available. Out of 194 participants, one was excluded from the ITT population due to missing Hb measurement and C.E.R.A drug after Week 0.|||g/dL||Standard Deviation|Mean
1446356|NCT00882713|Primary|Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period|The percentage of participants who maintained their mean Hb concentration within +/- 1 g/dL of their reference Hb and between 10.5 and 12.5 g/dL during the Efficacy Evaluation Period (EEP) is reported. The EEP was from Week 17 to Week 24. The reference Hb was calculated from the mean of Hb concentrations based upon the Hb assessments at Weeks -4, -3, -2, -1, and 0.|EEP (Week 17 to Week 24)|The per-protocol (PP) population included all participants from the intention-to-treat (ITT) population, who fulfilled inclusion/exclusion criteria as per the study protocol. A total of 123 participants were included in the PP population.|||Percentage of participants||95% Confidence Interval|Number
1446357|NCT00882687|Secondary|Conjunctival Redness at Day 6 (CAC 4), 5 (CAC 7)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 6 (CAC 4), Day 13 (CAC 7) at 20 minutes post CAC|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
1446358|NCT00882687|Secondary|Ocular Itching at Day 6 (CAC 4), 5 (CAC 7)|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.|Baseline to Day 6 (CAC 4), Day 13 (CAC 7) 7 minutes post CAC|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
1446359|NCT00882687|Primary|Conjunctival Redness at Day 14 (20 Minutes Post CAC 9)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 14 (20 minutes post CAC 9)|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
1446360|NCT00882687|Primary|Conjunctival Redness at Day 7 (20 Minutes Post CAC 6)|Conjunctival Redness was evaluated by an investigator with slit lamp and graded with ORA Scale with the score ranged from 0 to 4 (0=none; 1=mild-slightly dilated blood vessels; color of vessels is typically pink; can be quadrantal; 2=moderate-more apparent dilation of blood vessels; vessel color is more intense (redder); involves the majority of the vessel bed; 3=severe-numerous and obvious dilated blood vessels; in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4=extremely severe-large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed) with 0.5 point increments allowed, and lower scores indicates reduction in the conjunctival redness.|Baseline to Day 7 (20 minutes post CAC 6)|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
1446361|NCT00882687|Primary|Ocular Itching at Day 14 (7 Minutes Post CAC 9)|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching.|Baseline to Day 14 (7 minutes post CAC 9)|ITT population with LOCF|||units on a scale||Standard Deviation|Mean
1446362|NCT00882687|Primary|Ocular Itching at Day 7 (7 Minutes Post Conjunctival Allergen Challenge [CAC 6])|Ocular Itching was evaluated by participants and graded with Ophthalmic Research Associates, Inc. (ORA) Scale with the score ranged from 0 to 4 (0=none; 0.5=intermittent tickle in the cornea; 1=intermittent tickle more than just the cornea; 1.5=intermittent all-over tickling sensation; 2=mild conscious itch without desire to rub; 2.5=moderate, diffuse continuous itch with desire to rub; 3=severe itch with desire to rub; 3.5=severe itch improved with minimal rubbing; 4=incapacitating itch with an irresistible urge to rub) with 0.5 point increments allowed, and lower scores indicates lesser ocular itching. CAC is an initial titration challenge to determine the appropriate allergen and lowest concentration of allergen that produced a positive bilateral allergic response for each subject, defined as ≥ 2 score (0-4 point scale) in ocular itching and conjunctival redness within 10 minutes of the last titration of allergen.|Baseline to Day 7 (7 minutes post CAC 6)|Intent-to-treat (ITT) population with last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1448687|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 2|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 2|FAS (LOCF)|||participants|||Number
1446363|NCT00882661|Secondary|Satisfaction|Patient satisfaction (definitely/mostly): proportion of patients|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Patient Satisfaction data was available for 78 non-randomized SECURE-C patients, 139 randomized SECURE-C patients and 115 control patients at 24 months.|||participants|||Number
1446364|NCT00882661|Secondary|SF-36 MCS|Health Status Survey SF-36 mental composite scores: 15% improvement from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 MCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.|||participants|||Number
1446365|NCT00882661|Secondary|SF-36 PCS|Health Status Survey SF-36 physical composite scores: 15% improvement from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete SF-36 PCS data was available for 78 non-randomized SECURE-C patients, 138 randomized SECURE-C patients and 114 control patients at 24 months.|||participants|||Number
1446366|NCT00882661|Secondary|Right Arm Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in right arm pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Right Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C patients, 133 randomized SECURE-C patients and 108 control patients at 24 months.|||participants|||Number
1446367|NCT00882661|Secondary|Left Arm Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in left arm pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Left Arm Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.|||participants|||Number
1446368|NCT00882661|Secondary|Neck Pain Visual Analog Scale (VAS)|Improvement of 20mm from baseline in neck pain measured using the Visual Analog Scale (VAS)|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Pain Visual Analog Scale (VAS) data was available for 75 non-randomized SECURE-C, 133 randomized SECURE-C patients and 108 control patients at 24 months.|||participants|||Number
1446369|NCT00882661|Secondary|Neck Disability Index (NDI)|Neck Disability Index (NDI) success defined as ≥25% improvement at 24 months from baseline|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete Neck Disability Index (NDI) data was available for 78 Non-randomized SECURE-C patients,139 randomized SECURE-C patients and 116 control patients at 24 months.|||participants|||Number
1446370|NCT00882661|Primary|Individual Patient Overall Success|Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion|24 months|At the time of database lock, of the 380 patients enrolled in the PMA study, all had reached the 24 month post-operative visit. Complete primary endpoint data was available for 79 Non-randomized SECURE-C patients,141 randomized SECURE-C patients and 114 control patients at 24 months.|||participants|||Number
1446371|NCT00882583|Primary|1.Maximally Tolerated Dose (MTD) of Daily Oral Dasatinib in Combination With Cetuximab/RT in Cohort A 2. MTD of Daily Oral Dasatinib in Combination With Cisplatin/Cetuximab/RT in Cohort B|The MTD for Dasatinib was defined as a) the dose producing DLT ( Dose limiting toxicity) in 0-1 out of 6 patients, or b) the dose level below the dose which produced DLT in <2 out of 6 patients, or c) the dose of 150mg PO QD with less than 33% rate of DLT.|Last day of Radiation|MTD not reached. Study closed to slow accrual.|||participants|||Number
1446372|NCT00882583|Primary|Phase I is Efficacy and Safety. Phase II Will be Tumor Response||Phase I will enroll over 12-18 months|||||||
1446373|NCT00882557|Secondary|Treatment-emergent Adverse Events|Safety was monitored throughout the study, including observation and reports of AEs as well as changes in physical findings, vital signs, ECGs, and laboratory tests.|Up to 9 days after the last dose of study drug administration (Day 13 to Day 17 for those dosed on Day 8 and Day 20 to Day 24 for those dosed on Day 15).|Safety population, defined as all subjects who received at least one dose of daptomycin|||participants|||Number
1446374|NCT00882557|Other Pre-specified|Volume of Distribution|Volume of distribution at steady state (mL) calculated as the product of clearance and mean residence time.|Up to 68 hours post dose||||mL/kg||Full Range|Median
1446375|NCT00882557|Other Pre-specified|Clearance of Daptomycin|Plasma clearance is dose (µg) divided by area under the concentration versus time curve from time 0 to last quantifiable concentration time.|Up to 68 hours post dose|PK Population - defined as all subjects who received both doses of daptomycin|||mL/hr/kg||Full Range|Median
1446376|NCT00882557|Other Pre-specified|Half-life|Apparent terminal half-life.|Up to 68 hours post dose||||Hours||Full Range|Median
1446377|NCT00882557|Other Pre-specified|Time to Maximum Concentration|Sampling time at which maximum plasma concentration occurred, obtained directly from the experimental plasma concentration time data, without interpolation.|Up to 68 hours post dose||||Hours||Full Range|Median
1446378|NCT00882557|Other Pre-specified|Maximum Plasma Concentration|Maximum plasma concentration over the entire sampling phase directly obtained from the experimental plasma concentration time data, without interpolation.|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|PK Population - defined as all subjects who received both doses of daptomycin|||ug/mL||Full Range|Median
1446379|NCT00882557|Primary|Evaluation of Area Under the Curve From Time 0 to Infinity|Area under the plasma concentration versus time curve from time 0 to infinity for daptomycin doses|Within 30 minutes prior to the start of the infusion, mid-infusion, and end of the infusion; at 1, 2, 4, 6, 9, 24, and 48 hours after the end of the infusion; and just prior to the next hemodialysis session (i.e., 68 hours post-infusion)|The primary endpoints are measured on the PK population, defined as all subjects who received both the 6 mg/kg dose and 9 mg/kg dose|||hr*ug/mL||Full Range|Median
1446380|NCT00882518|Secondary|Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42|6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
1446381|NCT00882518|Secondary|Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42|"6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least “minimally improved” at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient’s change from baseline CGI on a seven-point scale (1=”Very much improved”, 7=”Very much worse.)"|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||percentage of participants|||Number
1446382|NCT00882518|Secondary|Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.~1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme."|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||Percentage of participants|||Number
1446383|NCT00882518|Secondary|Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
1446384|NCT00882518|Secondary|Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42|"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme"|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
1446385|NCT00882518|Secondary|Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42|The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
1446386|NCT00882518|Secondary|Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
1446387|NCT00882518|Secondary|Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42|6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and 6 weeks|Full analysis set was used for secondary outcome|||scores on a scale||Standard Error|Least Squares Mean
1446388|NCT00882518|Primary|Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42|6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse.|Baseline and 6 weeks|Per-protocol population was used as the analysis set for primary outcome, because this is a non-inferior design study.|||scores on a scale||Standard Error|Least Squares Mean
1446389|NCT00882440|Secondary|Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8||6 hours post dose at Baseline and 8 weeks|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1446390|NCT00882440|Primary|Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8||24 hours post dose at Baseline and Week 8|"The primary analysis employed an all patients treated approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||mm Hg||Standard Deviation|Mean
1446391|NCT00882440|Secondary|Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8|"Patients in Category I (defined as excellent in protocol) if SuDBP was <90 mmHg, Category II (defined as good in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as fair or inadequate in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg."|24 hours post dose at Week 8|"An all patients treated approach was employed that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available."|||Participants|||Number
1446392|NCT00882362|Primary|Montgomery–Asberg Depression Rating Scale (MADRS)|"Change from baseline to Last Observation Carried Forward (LOCF).~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline(Day 1), Week52 or at discontinuation||||Rating Score||Standard Error|Mean
1446393|NCT00882310|Secondary|Score on FACT-Hep (Version 4)|"Quality of life score of patients treated with the adjuvant GTX regimen using, the FACT-Hep (Version 4), a sensitive measure of quality of life.~Data was not analyzed because original PI left institution before data analysis was completed."|Prior to starting treatment, after 3 months of treatment, and at the end of study visit.|||||||
1446394|NCT00882310|Secondary|Time to Death|"Median recurrence free survival in patients with non-metastatic, resected pancreatic cancer treated with adjuvant GTX.~Data was not analyzed because original PI left institution before data analysis was completed."|At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.|||||||
1446395|NCT00882310|Primary|Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)|"Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.~Data was not analyzed because original PI left institution before data analysis was completed."|At days 4, 11, and follow-up.|||||||
1446396|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 33|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.|||percentage of DNA||Standard Deviation|Mean
1446397|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 5|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.|||percentage of DNA||Standard Deviation|Mean
1446398|NCT00882206|Secondary|Level of Methylation|the percentage of methylated DNA|Day 0||||percentage of DNA||Standard Deviation|Mean
1446399|NCT00882206|Primary|Response to Treatment|Response includes both complete remission (defined as <5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33)|Day 33|The following participants were removed from the analysis: two patients had an early death; one patient had early disease progression; one patient was found to have nervous system involvement on day 5 of therapy; and one patient stopped study therapy due to toxicities.|||participants|||Number
1446400|NCT00882102|Primary|Number of Participants With a Complete Response|Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with </= 5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9 /l, and a platelet count of >/= 100 & 10^9 /l. Approximately Day 14 of the first cycle of 4 - 8 week cycle, a bone marrow aspirate was performed to check the status of the disease using International Working Group (IWG) criteria for acute myelogenous leukemia (AML) and myelofibrosis (MF).|Day 14 of first cycle||||Participants|||Number
1446401|NCT00881959|Primary|Non –Inferiority of Dermis to Alloderm|Non –inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.|12 months||||mm||Standard Deviation|Mean
1446402|NCT00881894|Secondary|Apparent Dose|Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.|48 hours|Pharmacokinetic Set (PKS)|||mg||Standard Deviation|Mean
1446403|NCT00881894|Secondary|CL/f of Unconjugated Rotigotine|The CL/f is the apparent total body clearance.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||L/ h||Standard Deviation|Mean
1446404|NCT00881894|Secondary|t1/2 of Unconjugated Rotigotine|The t1/2 is the terminal half- life.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
1446405|NCT00881894|Secondary|λz of Unconjugated Rotigotine|The λz is the rate constant of elimination.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||1/ hour (1/h)||Standard Deviation|Mean
1446406|NCT00881894|Secondary|MRT of Unconjugated Rotigotine|The MRT is the mean residence time.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Standard Deviation|Mean
1446407|NCT00881894|Secondary|Tmax of Unconjugated Rotigotine|The Tmax is the time to reach a maximum plasma concentration after patch application.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||hour (h)||Full Range|Median
1446408|NCT00881894|Secondary|Cmax,Norm (BW) of Unconjugated Rotigotine|The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*kg||Standard Deviation|Mean
1446409|NCT00881894|Secondary|Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine|The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL) / mg||Standard Deviation|Mean
1446658|NCT00879775|Primary|Numeric Rating of Scale (From 0 to 10) of Pain and Possible Side Effects (Drowsiness, Confusion, Nausea) of Opioids|Scores were measured by Numeric Rating Scale. Scores range from 0 to 10; higher scores represent higher levels of pain, and possible side effects (drowsiness, confusion, nausea) of opioids.|two days|intention to treat|||scores|Participants|Standard Deviation|Mean
1446410|NCT00881894|Secondary|AUC(0-tz)Norm (BW) of Unconjugated Rotigotine|The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h*kg||Standard Deviation|Mean
1446411|NCT00881894|Secondary|AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine|The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*(h/ mg)||Standard Deviation|Mean
1446412|NCT00881894|Secondary|AUC(0-∞) of Unconjugated Rotigotine|The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
1446413|NCT00881894|Primary|Cmax of Unconjugated Rotigotine|The Cmax is the maximum plasma concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.|Pharmacokinetic Set (PKS)|||ng/ mL||Standard Deviation|Mean
1446414|NCT00881894|Primary|AUC(0-tz) of Unconjugated Rotigotine|The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.|Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application|Pharmacokinetic Set (PKS)|||(ng/ mL)*h||Standard Deviation|Mean
1446415|NCT00881868|Primary|Number of Participants Who Were a Success or Failure Based on the Global Severity Score (GSS) of Scalp Psoriasis From Baseline to End of Treatment (Week 4 or Week 2 if Clear)|Number of participants who were a success or failure based on the Global Severity Score (GSS) of Scalp Psoriasis from baseline to end of treatment (Week 4 or Week 2 if Clear). GSS is evaluated on a scale from 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe) with 0 being best and 5 being worst. Success is defined as Clear or Almost Clear. (Note: 5 Clobex Spray subjects and 0 Vehicle Spray subjects were Clear at week 2 and their results were carried forward to week 4).|baseline to week 4|ITT, LOCF|||participants|||Number
1446416|NCT00881868|Secondary|Number of Participants in Each Category of Pruritus at Baseline and Week 4|Number of participants in each category of Pruritus at end of treatment (week 4 or week 2 if GSS was Clear). Pruritus is evaluated on a scale from 0 - 3 (0 = None, 1 = Mild, 2 = Moderate and 3 = Severe) with 0 being best and 3 being worst.|baseline to week 4||||participants|||Number
1446417|NCT00881868|Secondary|Number of Participants in Each Category of the Extent of Scalp Involvement Index at Baseline and Week 4|Number of participants in each category of the Extent of Scalp Involvement Index at end of treatment (week 4 or week 2 if GSS was Clear). The Extent of Scalp Involvement Index is evaluated on a scale from 0 - 5 (0 = None, 2 = <20%, 2 = 20-39%, 3 = 40-59%, 4 = 60-79% and 5 = 80-100%) with 0 being best and 5 being worst.|baseline to week 4||||participants|||Number
1446418|NCT00881868|Secondary|Number of Participants in Each Category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at Baseline and Week 4|Number of participants in each category of the Scalp Psoriasis Individual Sign Scores (Scaling, Erythema and Plaque Elevation) at baseline and end of treatment (week 4 or week 2 if GSS is Clear). Individual Sign Scores are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very Severe) with 0 being best and 4 being worst.|baseline to week 4||||participants|||Number
1446419|NCT00881751|Secondary|Response Rate|Secondary outcome measures include response rate as assessed on restaging imaging studies utilizing RECIST 1.1.|From day 1 drug administration until 30 days after the last dose of study drug.|Responders include complete and partial responders defined by RECIST 1.1 criteria.|||percentage of participants|||Number
1446420|NCT00881751|Secondary|Number of SAEs Experienced|The study will report the number of SAEs experienced in each arm. All patients who receive any study drug will be evaluable for toxicity.|From day 1 of drug administration until 30 days after the last dose of study drug.|Patients who received at least one dose of study drug were included in this analysis.|||serious adverse events|||Number
1446421|NCT00881751|Secondary|Event-free Survival|EFS is defined as the time from randomization to any of the following three types of events: 1 - progression; 2 - withdrawal due to excessive toxicity; 3 - any other clinical event requiring withdrawal from the study.|From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study.||||Months||95% Confidence Interval|Median
1446422|NCT00881751|Primary|Overall Survival|Overall survival is defined as the time from treatment day 1 until death from any cause. Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.|from date of day 1 until the date of death|Only subjects who received one dose of study drug were considered for this outcome. 5 subjects enrolled to Arm II did not receive any study drug and were not evaluable for this outcome.|||Months||95% Confidence Interval|Median
1446423|NCT00881712|Secondary|Correlation of Functional CT-PET Imaging With Treatment Outcomes||Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years|This data was not collected as study was terminated early.||||||
1446424|NCT00881712|Secondary|Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy||Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually|This data was not collected as study was terminated early.||||||
1446425|NCT00881712|Secondary|Percentage of Patients Alive at 5 Years||Five years following radiation treatment|Thirteen enrolled patients that completed treatment.|||percentage of patients|||Number
1446659|NCT00879710|Secondary|Changes in Cholesterol Absorption or Synthesis Rates From the Baseline|We did not complete analyses of this outcome as we ran out of funds to measure these variables though samples have been collected.|6 weeks after initiation of drug therapy|||||||
1446426|NCT00881712|Secondary|Percentage of Patients With Disease Control|"Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.), as accurate."|Following treatment every 6 months for 2 years, then annually for 4 years.|Thirteen enrolled patients that completed treatment|||percentage of participants|||Number
1446427|NCT00881712|Primary|Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities||Six months after end of radiation therapy||||participants|||Number
1446428|NCT00881647|Primary|Sleep Efficiency (SE)|SE, as determined by polysomnography (PSG) and by self-reported sleep diary, was the total sleep time (TST) divided by the time in bed, multiplied by 100. This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation||||percentage of time||Standard Deviation|Mean
1446429|NCT00881647|Primary|Minutes of Wake After Sleep Onset (WASO)|WASO was the sum of wake time during sleep as recorded in a self-report sleep diary, and as measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]). This outcome consists of posttreatment (CBT-I) or post-waitlist diary entries and polysomnography data; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation|per protocol|||Minutes||Standard Deviation|Mean
1446430|NCT00881647|Primary|Sleep Latency (SL)|In a self-report sleep diary, participants were asked to report the length of time it takes from lying down for the night until sleep onset. This outcome consists of the posttreatment (CBT-I) or post-waitlist diary entry; In other words, each of the values below was measured at 8 weeks.|After 8 weeks of study participation||||minutes||Standard Deviation|Mean
1446431|NCT00881621|Secondary|Adverse Events|Grade 3 or 4 toxicities|2 years|grade 3 or 4 toxicities|||participants|||Number
1446432|NCT00881621|Secondary|Progression Free Survival|Time of study entry to cancer progression.|24 months|Time of study entry to disease progression.|||months||95% Confidence Interval|Median
1446433|NCT00881621|Secondary|Clinical Benefit Response|"number of participants who had stable disease or partial response or complete response per Response Evaluation Criteria In Solid Tumors.~Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|3 months||||participants|||Number
1446434|NCT00881621|Primary|Overall Survival|Time of study entry to time of death|24 months||||months||95% Confidence Interval|Median
1446435|NCT00881608|Secondary|Duration of Vaginal Bleeding Following Treatment With Proellex.||At least 2 days|Study prematurely terminated||||||
1446436|NCT00881608|Primary|Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.||An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses|Study prematurely terminated||||||
1446437|NCT00881530|Primary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.|78 weeks plus 1 week of follow-up|Treated set|||percentage of participants|||Number
1446438|NCT00881530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||mg/dL||Standard Deviation|Mean
1446439|NCT00881530|Secondary|Occurrence of a Relative Efficacy Response|Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of participants|||Number
1446440|NCT00881530|Secondary|Occurrence of a Treat-to-target Response (HbA1c < 6.5%)|Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of participants|||Number
1446441|NCT00881530|Secondary|Occurence of a Treat-to-target Response (HbA1c < 7.0%)|Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of participants|||Number
1446442|NCT00881530|Secondary|Change From Baseline in HbA1c Over Time|Baseline source: before first intake of active treatment (preceding trial or Open label extension)|Weeks 1, 6, 18, 30, 42, 54, 66 and 78|Treated set|||percentage of HbA1c||Standard Deviation|Mean
1446443|NCT00881530|Primary|Change From Baseline to Week 78 in Lipid Parameters|Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)|Weeks 1 and 78|Treated set|||mmol/L||Standard Deviation|Mean
1446444|NCT00881530|Primary|Hypoglycaemic Events|"Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration:~Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L)~Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L)~Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance~Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions"|78 weeks plus 1 week of follow-up|Treated set|||percentage of participants|||Number
1446676|NCT00879645|Secondary|Coagulation Factors||Baseline, Day 1, 2, and 7|||||||
1446446|NCT00881504|Primary|Progression-free Survival|Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.|2 years|"Primary outcome of 4 participants out of 8 was undetermined due to several reasons including patient refusal of further follow up.~Of the 4 patients remaining for analysis, progression free survival of 34, 26.3, 7, and 4.7 weeks was seen."|||weeks||Full Range|Median
1446447|NCT00881465|Secondary|Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 (“Very Much Improved) and 7 (“Very Much Worse”).|Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.|within one week after treatment condition was concluded||||participants|||Number
1446448|NCT00881465|Secondary|Clinical Global Impression – Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded||||units on a scale||Standard Deviation|Mean
1446449|NCT00881465|Primary|Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index.|Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.|within one week after treatment condition was concluded||||units on a scale||Standard Deviation|Mean
1446450|NCT00881335|Secondary|Number of Cases With Hospital Visit||up to 28 days||||participants|||Number
1446451|NCT00881335|Primary|FEV1/FVC%, the Ratio of FEV1 to FVC|"indicators of pulmonary function,~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days||||ratios||Standard Deviation|Mean
1446452|NCT00881335|Primary|FVC, Forced Vital Capacity|"indicators of pulmonary function, for example, FVC(unit of measurement:Liter)~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days||||L||Standard Deviation|Mean
1446453|NCT00881335|Primary|FEV1, Forced Expiratory Volume at First Second|"indicators of pulmonary function, for example, FEV1(unit of measurement:Liter)~All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study."|up to 28 days||||L||Standard Deviation|Mean
1446454|NCT00881335|Primary|MPEF,Mean Peak Expiratory Flow|indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.|up to 28 days||||L/min||Standard Deviation|Mean
1446455|NCT00881335|Secondary|Number of Cases With Antibiotics Therapy|antibiotics therapy is the indicators of pulmonary infection|up to 28 days||||participants|||Number
1446456|NCT00881335|Primary|Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)||up to 28 days||||participants|||Number
1446457|NCT00881205|Primary|Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population|The Selective Reminding Test(SRT) is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the patient should be in the testing room. A list of twelve words is read aloud by the examiner at a rate of one word per two seconds. The patient is asked to recall all twelve words. Only the words that are missed on the preceding trial are given in the consecutive trial. The total score represents a sum score of 6 trials, therefore the range is from 0-72. The lower the value the worse the outcome.|After 16 weeks of treatment|Due to low enrollment numbers study did not achieve the anticipated 80% power.|||units on a scale||Standard Deviation|Mean
1446458|NCT00880919|Primary|Sheehan Disability Scale (SDS)|Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment|Change in functional impairment from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446459|NCT00880919|Primary|Young Mania Rating Scale (YMS)|Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms|Change in manic symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446460|NCT00880919|Primary|Symptom Checklist -90-Revised (SCL-90-R)|90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms|Change in psychological problems and symptoms from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446489|NCT00880685|Primary|Yale Brown Obsessive Compulsive Scale Modified for KM (KM-YBOCS)|Scores could range from 0-40 with 0 being the least severe and 40 being the most severe. Here the total score was used. The KM-YBOCS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)||||units on a scale||Standard Deviation|Mean
1446461|NCT00880919|Primary|Barratt Impulsiveness Scale (BIS)|30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most.|Change in Impulsiveness from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446462|NCT00880919|Primary|Global Assessment of Functioning Scale (GAF)|Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional|Change in Global Assessment of Functioning from Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446463|NCT00880919|Primary|Overt Aggression Scale - Modified (OAS-M)|Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms.|Change from Baseline Overt Aggression Scale - Modified to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446464|NCT00880919|Primary|Borderline Evaluation of Severity Over Time (BEST)|Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst).|Baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446465|NCT00880919|Primary|Montgomery–Åsberg Depression Rating Scale (MADRS)|"Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest~0 to 6 – normal /symptom absent 7 to 19 – mild depression 20 to 34 – moderate depression >34 – severe depression."|baseline to 8 weeks|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Error|Mean
1446466|NCT00880919|Primary|Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)|This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse.|baseline, weekly until week 8|All subjects randomly assigned to a treatment group were included in the intent-to-treat analyses of baseline demographic and clinical characteristics. The efficacy analyses were limited to subjects with at least one post-randomization observation to guarantee measurement of change.|||units on a scale||Standard Deviation|Mean
1446467|NCT00880906|Secondary|Immunological Assessment Into the Etiology of Eosinophilic Esophagitis||60 days|Saved samples were not analyzed due to there being no difference in the primary outcome measure.||||||
1446468|NCT00880906|Primary|Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)|"Dysphagia Scores:~0 = able to eat normal diet / no dysphagia.~= able to swallow some solid foods~= able to swallow only semi solid foods~= able to swallow liquids only~= unable to swallow anything / total dysphagia"|60 days||||Percent Change|||Number
1446469|NCT00880763|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1446470|NCT00880763|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 6 weeks|The All Participants as Treated population consists of all randomized participants who received at least one dose of study treatment. Participants are included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
1446471|NCT00880763|Secondary|Change From Baseline in HCV RNA in log10 at Week 4|Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||IU/mL in Log10||Standard Deviation|Mean
1446472|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percentage of participants|||Number
1446473|NCT00880763|Secondary|Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4|Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.|Baseline and Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percentage of participants|||Number
1446677|NCT00879645|Secondary|12-lead ECG||Baseline, Day 0 through 7|||||||
1446678|NCT00879645|Secondary|Hematology||Baseline, Days 1 and 2|||||||
1446474|NCT00880763|Primary|Percentage of Participants Achieving Rapid Viral Response|Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was <1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.|Week 4|Per protocol population excludes participants for important deviations from the protocol that may substantially affect the results of the primary efficacy analysis.|||Percentage of participants|||Number
1446475|NCT00880750|Secondary|Time of Maximum Plasma Concentration (Tmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set|||hours||Full Range|Median
1446476|NCT00880750|Secondary|Maximum Plasma Concentration (Cmax) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|PK set|||ng/ml||Standard Deviation|Mean
1446477|NCT00880750|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lanthanum Carbonate||3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose on Day 4|Pharmacokinetic set (PK) includes all subjects who had sufficient post-dose blood samples taken to estimate Cmax and AUC 0-48 hours after dosing on Day 4 in all treatment periods. Subjects who vomited between dosing and 10 hours post-dose on Day 4 of any treatment period were excluded from the PK set.|||ng*h/ml||Standard Deviation|Mean
1446478|NCT00880750|Secondary|Urinary Phosphate Excretion on Day 4||Continuous collection on Day 4|PD set|||mmol||Standard Error|Least Squares Mean
1446479|NCT00880750|Primary|Urinary Phosphate Excretion 3-Day Average||Continuous collection over 3 days|Pharmacodynamic Set (PD) includes all subjects who completed all urine collections and consumed at least 95% of food in all treatment periods. Subjects who vomited from days -2 to 4 of any treatment period were excluded from the set.|||mmol||Standard Error|Least Squares Mean
1446480|NCT00880698|Secondary|Number of Participants Classified at Screening or Entry as HIV-1 Uninfected, and Acquiring HIV-1 Infection on Study|HIV tests were done at screening, entry and the last study visit after the third vaccination. Any participants classified as HIV-1 uninfected at screening or entry but HIV-1 infected at their last study visit would be classified as acquiring HIV-1 infection during the study|From study entry until at least 42 days after third vaccination|Includes HIV-1 uninfected participants 'as-randomized' with an HIV test at entry and either 2 or 6 weeks after the third vaccination (or after the time point at which they would have received the third vaccination if they did not receive all three doses)|||participants|||Number
1446481|NCT00880698|Secondary|Change in CD4 Count From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-infected participants 'as randomized' with a CD4 count measurement prior to first vaccination and at their last study visit|||cells/mm^3||Standard Deviation|Mean
1446482|NCT00880698|Secondary|Change in CD4 Percent From Entry to Last Study Visit in HIV-1 Infected Participants|Change calculated as value at last study visit minus value closest to and before randomization date|At entry and 42 days after third vaccination or last study visit with CD4 measurement|Includes HIV-1 infected participants 'as-randomized' with a CD4 percent measurement prior to first vaccination and at last study visit|||Percentage of lymphocytes||Standard Deviation|Mean
1446483|NCT00880698|Secondary|Percentage of HIV-1 Infected Participants With HIV-1 RNA <= 400 Copies/ml|Percentage of HIV-1 infected participants with HIV-1 RNA <= 400 copies/ml at last study visit|42 days after third vaccination or last study visit with an HIV-1 RNA measurement|Includes HIV-infected participants 'as-randomized' with an HIV-1 RNA measurement at their last study visit|||Percentage of participants|||Number
1446484|NCT00880698|Secondary|Number of Participants With Fecal Shedding of RotaTeq Strains After Each Vaccination|Number of participants with at least one positive enzyme immuno assay (EIA) rotavirus antigen test, positive fluorescent focal assay, and specific for rotavirus gene 6 which codes for the VP6 protein after each vaccination.|At entry, days 7, 14, 21 and 42 days after first dose, and at days 7 and 21 after the second and third doses|All participants 'as randomized'|||participants|||Number
1446485|NCT00880698|Primary|Percentage of Participants Classified as Responders as Measured by Serum Anti-rotavirus IgA ELISA (IgA) and Serum Neutralizing Antibodies (SNA) G1, G2, G3, G4 and P1.|Percentage of participants who experienced >=3-fold increases from prior to the first vaccination to at least 14 days after the third vaccination in Iga, SNA G1, SNA G2, SNA G3, SNA G4 and SNA P1.|Prior to first vaccination and at least 14 days after third vaccination|Only participants in the per-protocol population (received all 3 as-randomized vaccinations within recommended windows) and with measurements prior to the first vaccination and at least 11 days after the third vaccination and whose levels at the entry time point were less than one third of the upper limit of detection of the assay were included.|||Percentage of participants||95% Confidence Interval|Number
1446486|NCT00880698|Primary|Percentage of Participants Developing New Grade >=3 Adverse Events|Percentage of participants developing new grade >=3 adverse events (abnormal laboratory values (hematology and chemistry), signs, symptoms and diagnoses) not present at the time of the first vaccination. Adverse events were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 1.0, December 2004, Clarification August 2009).|From study entry until at least 42 days after third vaccination|Participants classified 'as'randomized'. Includes all follow-up on participants unblinded during the study and found to be on RotaTeq. Follow-up on participants unblinded during the study and found to be on placebo censored at the time of their last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
1446487|NCT00880685|Secondary|Clinical Global Impression Severity Scales (CGI)|The overall impression of the clinician of the severity of the subject. Scores between 1 and 7 with 1 not being ill at all and 7 being one of the worst cases seen. CGI is given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)||||units on a scale||Standard Deviation|Mean
1446488|NCT00880685|Secondary|Kleptomania Symptom Assessment Scale (K-SAS)|Scale used to measure severity of kleptomania. Scores could range from 0-36 with 0 being the least severe and 36 being the most severe. Here the total score was used. The K-SAS was completed at every visit (1-5), but the final visit (visit 5) will be the only score reported. The scale was given at baseline and weeks 2, 4, 6, and 8. Only the last visit (week 8) will be reported here.|Week 8 (last visit)||||units on a scale||Standard Deviation|Mean
1446490|NCT00880620|Secondary|Summary of Change From Baseline to End of Study in Mean Parkinson's Disease Questionnaire-39 (PDQ-39) Score|"Change from Baseline in Parkinson's disease Questionnaire 39 (PDQ-39) at Weeks 4, 9, 16, 23 and 30 or early discontinuation was collected. The PDQ-39 is a self-reported questionnaire consisting of 39 questions regarding the subjects mobility and the responses consist of Never (better in outcome), (value 0), Occasionally (value 1), Sometimes (value 2), , Often (value 3), and Always (value 4), (worse in outcome). The minimum possible score is 0 and the maximum is 156. The outcome measure calculated was the change from baseline to end of study in mean PDQ-39 score. Negative values indicate a better result."|Baseline and Week 30 (or End of Study)|Subjects who had no postbaseline efficacy assessments (N=4) and those who had early termination assessments >3 days after last dose and no other postbaseline measurements (N=16) were not included in the efficacy analysis. 2 subjects without a baseline measurement, 1 each from 145mg and 390mg arm were also excluded. Randomized 381-4-16-2=359.|||score on a scale||Standard Deviation|Mean
1446491|NCT00880620|Primary|Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III at Week 30|"Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at Week 30 (End of Study).~Unified Parkinson’s Disease Rating Scale (UPDRS) – Four Parts Higher score values represent a worse outcome.~Subscales II and III were summed:~Part I: Mentation, Behavior and Mood – 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living – 13 questions 5-17 Score range: 0-52 Part III: Motor Examination – 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) – 11 questions Score range: 0-25"|Week 30|Analysis included all treated subjects with at least one efficacy measurement after dosing. Subjects who had no post-baseline efficacy assessments (N4) and those who had early termination assessments>3 days after last dose and no other post-baseline measurements (N16) were not included in the efficacy analysis set. Randomized (381)-(4+16) = 361.|||units on a scale||Standard Deviation|Mean
1446492|NCT00880581|Secondary|Response Rate After Cycle 2|"Response after a second cycle of treatment was assessed per the Cheson Criteria, as below.~Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease~CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia~Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR."|6 months|Participants with progressive disease (PD) were not re-evaluated.|||participants|||Number
1446493|NCT00880581|Primary|Overall ObjectiveResponse (ORR) Rate|"Overall objective response rate (OOR) at time of best response was assessed as the sum of the Complete Response (CR) rate and the Partial Response (CR, PR) rate. Response was assessed per the Cheson Criteria, as below.~Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease~CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia~Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR."|12 weeks||||participants|||Number
1446494|NCT00880568|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event|This is a measure of the number of participants who experienced any adverse event (AE) while on study.|First dose up to 30 days after last dose (up to 2 years)|All participants on study|||participants|||Number
1446495|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.~AUC[0-24] for the Day 1 doses is reported as Outcome Measure 4."|Cycle 1, Day 3 (Hour 0 through Hour 24)|All participants in the first 28-day cycle|||hr*nmol/L||Standard Deviation|Mean
1446496|NCT00880568|Secondary|Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)|"AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.~AUC[0-24] for the Day 3 doses is reported as Outcome Measure 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants in the first cycle of the 28-day dosing schedule|||hr*nmol/L||Standard Deviation|Mean
1446497|NCT00880568|Secondary|Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)|"AUC[0-24] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle.~AUC[0-24] for the 28-day cycle is reported as Outcome Measures 4 and 5."|Cycle 1, Day 1 (Hour 0 through Hour 24)|All participants on the 21-day dosing schedule|||hr*nmol/L||Standard Deviation|Mean
1446498|NCT00880568|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.|Cycle 1 (up to 21 or 28 days, depending on treatment arm)|All participants in the first cycle of each dosing schedule (21 or 28 days)|||participants|||Number
1446499|NCT00880555|Primary|FCI Score at Follow-up|At each research visit, participants undertook 5 portions of the Financial Capacity Instrument (Domains 2, 3, 4b, 5, and 7). We report the total FCI score across the five domains tested, which has a range of possible scores from 0-191. Higher scores reflect greater capacity for understanding financial concepts and handling financial tasks.|Year 1, Year 2, Year 3|Individuals completing at least one assessment following baseline|||points awarded for correct items||Standard Deviation|Mean
1446500|NCT00880542|Secondary|Local and Distant Recurrence-free Survival||conclusion of study|Due to study closing early and the few number of participants enrolled, the outcome measures were not done.||||||
1446679|NCT00879645|Secondary|Urinalysis||Baseline, Days 1, 2, and 7|||||||
1446501|NCT00880542|Primary|Using PET/CT Scan to Measure Safety, Toxicity, and Efficacy of Neoadjuvant Sorafenib Tosylate and Ifosfamide in Patients With Resectable High-grade Soft Tissue or Bone Sarcoma.|After cycle 1, a limited PET/CT scan of the affected site will be performed to assess response to sorafenib treatment alone. After cycle 3, prior to surgery, a limited PET/CT scan of the affected site will be performed to assess response to the combination sorafenib and ifosfamide treatment.|Participants were followed for duration of study, an average of 1 year.|Due to the study closing early and the few number of participants enrolled, the outcome measures were not done.||||||
1446502|NCT00880425|Secondary|Number of Patient With Daily Headache Who Have Non-continuous Headache|Number of patient with Daily Headache who have non-continuous headache|Records were reviewed from April 2009 through June 2009||||participants|||Number
1446503|NCT00880425|Primary|Number of Subjects With Daily Headache Who Have Continuous Headache|The number of subjects with Daily Headache who have continuous headache|Records were reviewed from April 2009 through June 2009||||participants|||Number
1446504|NCT00880399|Secondary|Change From Baseline in the MSFQ Total Score-Females|The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following four areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; and (4) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 4 to 24, where 5 represents greater than normal functioning and 24 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome.|Baseline (Day 1) to Week 6|Only females from all subjects population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446505|NCT00880399|Secondary|Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ)-Males|The MSFQ is a self report rating scale derived from the Guided Interview Questionnaire for females and males. The questionnaire includes five questions with a score for each question ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas of sexual functioning were included: (1) diminished/absent libido; (2) arousal difficulties; (3) orgasm difficulties/anorgasmia; (4) erectile dysfunction (males only) and (5) degree of sexual satisfaction. A total score (sum of individual question score) was used as a global measure of sexual dysfunction which ranged from 5 to 30, where 5 represents greater than normal functioning and 30 represents poorer function (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. A negative change from Baseline was considered a positive outcome.|Baseline (Day 1) to Week 6|Only males from all subjects population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446506|NCT00880399|Secondary|Number of Discontinuation-emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)|The discontinuation signs and symptoms scale consists of 43 signs and symptoms, scored as ‘new symptom’, ‘old symptom but worse’, ‘old symptom but improved’ or ‘ symptom not present/old symptom but unchanged’. A frequency table for each symptom is reported by treatment and visit. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms are calculated for treatment and visit and reported.|Week 1 to Week 8/Follow up 1|All subjects population comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Signs and symptoms||Standard Deviation|Mean
1446507|NCT00880399|Secondary|Number of Participants With Suicidal Behavior, Ideation, and Most Common Ideation Using the Columbia Suicidality Severity Rating Scale (C-SSRS)|The C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both behavior and ideation. It has 3 sections, Suicidal Behavior (SB), Suicidal Ideation (SI) and Intensity of Ideation (II). For SB, participants (par) were scored non-suicidal:0, preparatory acts or behavior communicating ideation:1, aborted attempt:2, interrupted attempt:3 or actual attempt:4 (most severe). For SI, par were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). II scale made of 5 questions measuring frequency, duration, controllability, deterrent and reasons; par received a separate score on most common ideation and on most severe. Total II score is obtained by adding scores from all 5 questions.|Week 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1446508|NCT00880399|Secondary|Number of Participants Who Remit (Have an Endpoint HAM-D Total Score <= 7) Who Continue to Show Symptoms on the HAM-D Sleep Items|A HAM-D remitter was defined as a participant with a HAM-D total score less than or equal to 7. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1446554|NCT00880191|Secondary|Level of Satisfaction for the Control of Nausea.|Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index – Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)|Days 1 through 6|203 patients in Gabapentin arm and 201 patients in Placebo arm submitted the data for this endpoint.|||units on a scale||Standard Deviation|Mean
1446680|NCT00879645|Secondary|Vital Signs||Study duration|||||||
1446509|NCT00880399|Secondary|Change From Baseline in MSQ Values for Sleep Quality (SQ) and Refreshing Value of Sleep (RVS)|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The score relating to SQ and RVS was measured by items/questions 4 and 5 respectively of the MSQ. The following two variables SQ and RVS were assessed in order to determine effects on sleep. Participants were asked to rate their SQ and RVS on a scale of 1 to 10. This scale has no subscales. The total score for SQ and RVS, both, ranged from 1 to 10 where 1=poor and 10=excellent. Lower scores indicated poor SQ and RVS and higher scores indicated excellent SQ and excellent RVS. During the conduct of study, participants self-administered MSQ via an IVRS from their home the morning of each clinic visit. If a participant did not remember to place IVRS MSQ call the morning of the clinic visit from home, they were allowed to place call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446510|NCT00880399|Secondary|Change From Baseline in MSQ Values for Number of Nocturnal Awakenings|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Awakenings||Standard Error|Least Squares Mean
1446511|NCT00880399|Secondary|Change From Baseline in Morning Sleep Questionnaire (MSQ) Values for Total Sleep Time (TST), Sleep Onset Latency (SOL) and Wake Time After Sleep Onset (WTSO)|The MSQ is a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following six variables were assessed in order to determine effects on sleep: (1) total sleep time, (2) sleep onset latency, (3) number of nocturnal awakenings, (4) wake time after sleep onset, (5) sleep quality (where poor=1 and excellent= 10) and (6) the refreshing value of the sleep (where poor=1 and excellent= 10). During the conduct of the study, participants self-administered the MSQ via an Interactive Voice Response System (IVRS) from their home the morning of each clinic visit. Participants were provided paper MSQ diary cards for note taking prior to completing the IVRS call. If a participant did not remember to place the IVRS MSQ call the morning of the clinic visit from home, they were allowed to place the call during in the clinic during their visit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Minutes (mins)||Standard Error|Least Squares Mean
1446512|NCT00880399|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score|The CPFQ is a brief self-report scale which is designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The scale comprises 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question is rated on a scale of 1 to 6, (1 = greater than normal; 2 = normal; 3 = minimally diminished; 4=moderately diminished; 5 = markedly diminished; and 6 = totally absent). The following five areas were included: motivation/interest/enthusiasm; wakefulness/alertness; energy; focus/sustain attention; remember/recall information; find words and sharpness/mental acuity. The total score (sum of individual question scores) ranged from 7 to 42. Lower score 7 represents greater than normal functioning and higher score 42 indicate poorer functioning (worst outcome). Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) and Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446513|NCT00880399|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. For the CGI-S, an independent site rater assessed the participant’s severity of illness considering (1) their total clinical experience with the particular population being studied and (2) information obtained during the Baseline HAM-D interview with the participant. The severity of illness (CGI-S) item is rated on a 1 to 7 scale such that 1 (normal, not at all ill) and 7 (among the most extremely ill). Higher scores indicate worsening. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446514|NCT00880399|Secondary|Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved)|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. Global improvement (CGI-I) item is rated on a 1-7 scale. The CGI-I assessed scores range from 1 - very much improved to 7 - very much worse. For the CGI-I, the investigator or delegated qualified clinician indicated their assessment of the participant’s total improvement or worsening compared with the individual’s condition at the start of the study whether or not the change was judged to be due to drug treatment. A participant with a CGI-I score of 1 'very much improved' or 2 'much improved' was considered a responder. Percentage of responders are reported.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1446551|NCT00880230|Secondary|Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)|The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.|30 Days|Intent to Treat Population (ITT)|||Percentage of Patients|||Number
1446515|NCT00880399|Secondary|Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)|The HAMD anxiety factor score includes 6 items/questions (item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, item 13: somatic symptoms general, item 15: hypochondriasis and item 17: insight). The items are rated on a scale of 0 to 4 (items 10, 11 and 15) or 0 to 2 (items 12, 13 and 17), higher scores reflecting greater severity. The highest possible score is 18, which represents the most severe measure of anxiety; the lowest possible score is 0, which represents an absence of anxiety. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446516|NCT00880399|Secondary|Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score|The QIDS-SR is a self-report rating scale that assesses symptom severity of major depressive disorders. The QIDS-SR utilized during this study contained 16 separate items which correspond to 9 symptom criterion domains: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation,(5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation. The QIDS-SR total score was calculated using the sum of the domain scores. The highest possible total QIDS-SR score is 27, which represents the most severe measure of depression. The lowest possible score is 0, which represents an absence of depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446517|NCT00880399|Secondary|Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAMD Scale)|The Bech Melancholia is sum of scores on 6 items/questions (item 1: depressed mood, item 2: feelings of guilt, item 7: work and activities, item 8: retardation, item 10: anxiety psychic and item 13: somatic symptoms general) pertaining to melancholia within HAM-D. The items are rated on a scale of 0 to 4 (items 1, 2, 7, 8 and 10) or 0 to 2 (item 13), higher scores reflecting greater severity. The highest possible score is 24, which represents the most severe measure of melancholy; the lowest possible score is 0, which represents an absence of melancholy. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446518|NCT00880399|Secondary|Number of Participants With (Maintained) Clinical Response|Clinical response or antidepressant response was defined as >= 50% reduction from randomization in their HAMD total score, where this response was maintained until the end of the Treatment Phase (Week 6). Participants who met the >= 50% reduction at Week 6 without also having met it at Week 4 were not considered to have reached a maintained response, and therefore were censored at Week 6. Number of participants with maintained clinical response are reported.|Up to Week 6|ITT Population.|||Participants|||Number
1446519|NCT00880399|Secondary|Percentage of Participants With a >= 50 Percent (%) Reduction From Baseline in HAM-D Total Score|Participants who had 50% or greater reduction from Baseline in their total HAMD score were termed as responders. The HAM-D was designed to measure the severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items that are ranked on a scale of 0 to 4 or 0 to 2. Items with quantifiable severity are scored 0 to 4 (4 indicating the greatest severity) or 0 to 2 (2 indicating the greatest severity) with 0 indicating not present. The HAM-D Total Score is calculated by summing the individual response scores on the HAM-D questionnaire. The highest possible score is 52, which represents the most severe measure of depression; the lowest possible score is 0, which represents an absence of depression. The HAM-D is also useful for monitoring changes in depressive symptoms with treatment and in comparing the efficacy of various interventions if the participant requires more than one type of treatment. Baseline was Day 1.|Baseline (Day 1) to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1446520|NCT00880399|Primary|Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score|The HAM-D is designed to measure severity of depressive symptoms in participants with primary depressive illness. The scale is a checklist of items (1: depressed mood, 2: feelings of guilt, 3: suicide, insomnia early, 4: insomnia early, 5: insomnia middle, 6: insomnia late, 7: work and activities, 8: retardation, 9: agitation, 10: anxiety psychic item 10: anxiety psychic, item 11: anxiety somatic, item 12: somatic symptoms gastrointestinal, 13: somatic symptoms general, 14: genital symptoms, 15: hypochondriasis, 16: loss of weight and 17: insight) that are ranked on a scale of 0 to 4 or 0 to 2 (4 and 2: highly severe and 0: not present). The HAM-D total score is calculated by summing individual response scores on the HAM-D questionnaire. The highest possible score is 52, representing most severe measure of depression; lowest possible score is 0, representing no depression. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.|Baseline (Day 1) to Week 6|The Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of double blind medication and for whom at least one post-randomization assessment was available. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
1446521|NCT00880360|Secondary|Toxicity|Determine any toxicity associated with Ontak treatment in these patients.|3 years|N/A data were not collected||||||
1446522|NCT00880360|Primary|Number of Participants Demonstrating Clinical Response|Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.|2 years|Measurements performed by RECIST criteria and response reported as a percent. 56 subjects needed to be recruited to the study to determine efficacy. Analysis was on an intent to treat basis.|||participants|||Number
1446552|NCT00880230|Primary|Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.|The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.|In-hospital and 9 Months|Intent to Treat Population (ITT)|||Percentage of Participants|||Number
1446523|NCT00880334|Post-Hoc|Disease Control Rate|Disease control rate is defined as the percentage of participants with confirmed overall Stable Disease (SD) or better using RECIST 1.0 criteria which parallels absence of disease progression (PD) on treatment during the randomized phase. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients without measurable disease only at baseline are included, based on status of non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).||||percentage of participants||95% Confidence Interval|Number
1446524|NCT00880334|Secondary|Objective Response Rate|Objective response rate is defined as the percentage of participants who achieved a confirmed overall partial response (PR) or complete response (CR) using RECIST criteria on treatment during the randomized phase. Patients without measurable disease only at baseline are included, based on status of non-target lesions.Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.|||percentage of participants||95% Confidence Interval|Number
1446525|NCT00880334|Secondary|Median Overall Survival|Overall survival is defined from date of randomization to date of death or censored at the date the patient was last known alive.|Off treatment, patients were followed for survival information every 6 months (±1 month) until death,up to 2 years after discontinuing therapy, or until lost to follow-up. Median survival follow-up for the study cohort was 12 months (95% CI: 9-18 months).|The analysis dataset is comprised of all eligible and treated patients.|||months||95% Confidence Interval|Median
1446526|NCT00880334|Secondary|Grade 3-5 Toxicity Rate|Grade 3-5 toxicity rate is the percentage of participants experiencing maximum grade of all toxicity types of grade 3-5 with any attribution on treatment during the randomized phase.|Assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort approximated 2 cycles (range 1-31).|The analysis dataset is comprised of all eligible and treated patients.|||percentage of participants||95% Confidence Interval|Number
1446527|NCT00880334|Primary|Median Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease evaluations occurred at week 6 and 12 and thereafter every 3 cycles/9 weeks on treatment and every 3 months in follow-up. Participants were followed until PD, death or lost to follow-up. Median survival follow-up was 12 months (range 1-26).|The analysis dataset is comprised of all eligible and treated patients.|||months||95% Confidence Interval|Median
1446528|NCT00880269|Secondary|Overall Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
1446529|NCT00880269|Secondary|Event-free Survival Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
1446530|NCT00880269|Secondary|Duration of Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
1446531|NCT00880269|Secondary|Time to Remission Measured in Stratum A and B||6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
1446532|NCT00880269|Secondary|Partial Response Measured in Stratum A and B|As predefined in the study's protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi)|6 treatment cycles (28-day/treatment cycle)|No secondary analyses were performed since study enrollment was stopped early at stage 1 for lack of evidence of activity.||||||
1446533|NCT00880269|Primary|Best Response as Per Investigator Assessment by Stratum (FAS)|Response to treatment was defined as complete remission rate (CRR). CRR is complete remission (CR) and morphologic CR with incomplete blood count recovery (residual neutropenia or thrombocytopenia) (CRi). To stop or to proceed with Stage 2 of a given stratum of the Simon’s optimal 2-stage design was based on the number of patients with CR/CRi and a safety evaluation of the patients from Stage 1 in that stratum. If early results clearly indicated that the drug was not active or worthy of further investigation, enrollment of that particular stratum would be terminated. CR and CRi were assessed by the Investigator according to IWG response Criteria for AML (Cheson et al 2003). As per protocol we would continue to stage II if ≥ 4 patients out of 26 patients enrolled to stage I had a CR or a CRi. As per response observed there was only 1 patient with CR/CRi in stratum A and 2 patients with CR/CRi in Stratum B.|6 cycles of treatment with a 28-day treatment cycle (Day 168)|Full analysis set (FAS) is the same as the Safety set and includes all patients who received at least one dose of study drug. The FAS was used for final efficacy analyses.|||Percentage of Participants|||Number
1446553|NCT00880191|Secondary|Comparison of Daily Complete Response Endpoints|Daily complete response is defined as no emetic episodes and no use of rescue therapy.|Days 1 through 6||||percentage of participants|||Number
1446555|NCT00880191|Secondary|Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses|The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.|Days 1 through 6||||units on a scale||Standard Deviation|Mean
1446534|NCT00880256|Secondary|Irritable Bowel Syndrome (IBS) Quality of Life|The IBS-QOL is a disease specific Quality-of-Life Measure for IBS. IBS-QOL has been shown have a high level of content validity and to be responsive to change, and has been used in several outcome studies and clinical drug trials throughout the world. It consists of 34 questions that assess the influence of bowel habits on daily life. The response to each question is rated on a 5-point scale. A lower score indicates worse bowel-related quality of life. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).|6 months|All participants who completed at 6 months were included|||units on a scale||Standard Deviation|Mean
1446535|NCT00880256|Primary|IBS (Irritable Bowel Syndrome) Symptom Severity Score (Total Score)|The Irritable Bowel Severity Scoring System (IBSSS) provides a measure of the severity of IBS. The measure consists of five questions, which assess severity of abdominal pain, number of days with abdominal pain in past 10 days, severity of abdominal distension, satisfaction with bowel habits, and impact of IBS on life in general. The score on each of the 5 questions ranges from 0 to 100, and the scores are summed with a range of total possible scores from 0 to 500. Higher scores reflect more severe IBS. Total score was used in the analyses.|6 months|We compared scores at baseline, 2-month, and 6-month time points, using t-tests. A two-sided P value of less than 0.05 was considered statistically significant. The standardized mean difference (Cohen’s d effect size) from baseline to 2-months, and baseline to 6-months was calculated for each variable.|||units on a scale||Standard Deviation|Mean
1446536|NCT00880230|Secondary|Target Limb Loss|Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446537|NCT00880230|Secondary|Death|Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446538|NCT00880230|Secondary|Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months||||Percentage of Patients|||Number
1446539|NCT00880230|Secondary|Target Limb Revascularization|Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446540|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.|9 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446541|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.|9 Months|Intention to Treat (ITT)|||Percentage of Patients|||Number
1446542|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.|9 Months|Intention to Treat (ITT)|||Percentage of Patients|||Number
1446543|NCT00880230|Secondary|Patency - Secondary|Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.|6 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446544|NCT00880230|Secondary|Patency - Primary Assisted|Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.|6 Months|Intention to Treat (ITT)|||Percentage of Patients|||Number
1446545|NCT00880230|Secondary|Patency - Primary|Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.|6 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446546|NCT00880230|Secondary|Clinical Success|Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|9 Months|Intent to Treat Population (ITT)|||Percentage of Patients|||Number
1446547|NCT00880230|Secondary|Clinical Success|Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.|6 Months|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446548|NCT00880230|Secondary|Clinical Success|Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.|30 Days|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446549|NCT00880230|Secondary|Procedural Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system [Device Success] and the achievement of <30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).|Up to the moment the catheter sheath introducer has been removed|Intention to Treat Population (ITT)|||Percentage of Patients|||Number
1446550|NCT00880230|Secondary|Device Success|The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.|At time of deployment|Intent to Treat Population (ITT)|||Percentage of Patients|||Number
1446556|NCT00880191|Secondary|Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents|The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.|Days1 through 6||||percentage of participants|||Number
1446557|NCT00880191|Secondary|Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.|The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 1 through 6||||percentage of participants|||Number
1446558|NCT00880191|Secondary|Complete Response|The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.|Days 2-6||||percentage of participants|||Number
1446559|NCT00880191|Primary|Comparison of Percentage of Complete Responders|Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|Days 2 through 6||||percentage of participants|||Number
1446560|NCT00880165|Secondary|Continuous Positive Airway Pressure Adherence|Mean daily hours of use of continuous positive airway pressure over the 3 month intervention|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.|||hours per day||Standard Deviation|Mean
1446561|NCT00880165|Secondary|Functional Outcome of Sleep Questionnaire|Change score from baseline of self-administered validate questionnaire of functional outcome following 3 months of positive airway pressure treatment|3 months|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.|||units on a scale||Standard Deviation|Mean
1446562|NCT00880165|Primary|Cost|VA sleep-study and treatment medical service use will be derived from the case report form; and costed out using VA acquisition costs. Other medical service use will be derived from VA administrative records. Non-VA medical service use will be derived from patient interview and will be costed out using federal reimbursement schedules. Costs will be stratified by whether or not they are related to the diagnosis and treatment of OSA.Cost and preferences are assessed for each entire arm.|Medical service use and cost will be collected every 3 months for the entire observation period. Thus the shortest duration of follow-up in the study is anticipated to be 3 months, while the longest will be 2.25 years.|Participants diagnosed with obstructive sleep apnea who were prescribed continuous positive airway pressure (CPAP) treatment. Of the 148 individuals randomized to each arm, 110 in the in-lab testing arm and 113 in the home testing arm were prescribed CPAP. Results from these 223 subjects were used in the per protocol analysis.|||dollars|||Number
1446563|NCT00880100|Post-Hoc|Percentage of Patients With Control of Steatorrhea Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. There was no imputation of missing data. Here n signifies patients who were evaluable for each specific category."|||percentage of patients||95% Confidence Interval|Number
1446564|NCT00880100|Other Pre-specified|Percentage of Days With Abdominal Pain and Excessive Flatulence|Mean percentage of days with abdominal complaints during baseline phase (BP) and the 5-day collection period of the treatment phase for total patients was summarized. Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days abdominal pain (AP) and excessive flatulence (EF) in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specific category."|||percentage of days||Standard Deviation|Mean
1446565|NCT00880100|Other Pre-specified|Total Weight of Stools|The total weight of stools in grams (g) is the total weight obtained during the stool collection period regardless of the number of stools that had been collected during this same collection period. Mean total weight of stools in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here N (number of patients analyzed) represents number of patients who were evaluable for this outcome measure. Here n signifies patients who were evaluable for each specified category."|||gram (g)||Standard Deviation|Mean
1446566|NCT00880100|Secondary|Mean Number of Days Without Abdominal Complaints|Abdominal complaints were defined as the reporting of abdominal pain and/or unusual and excessive flatulence/gas production. Mean number of days without abdominal complaints in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||days||Standard Deviation|Mean
1446681|NCT00879645|Primary|Sodium Sulfide in Blood|Total concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.|8 hours after treatment||||ng/mL||Standard Deviation|Mean
1446682|NCT00879645|Primary|Thiosulfate in Urine|Total concentration of thiosulfate in urine was measure through pharmacokinetic urine collection|48 hours after treatment||||ng/mL||Standard Deviation|Mean
1446567|NCT00880100|Secondary|Percentage of Stools With Abnormal Characteristics|Stools of abnormal characteristics were defined as bulky/large, foul-smelling and/or oily stools. Mean percentage of stools with abnormal characteristics in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||percentage of stools||Standard Deviation|Mean
1446568|NCT00880100|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as hard and formed or soft and formed consistency. Abnormal consistency was defined as loose and unformed stool or liquid stools and diarrhea. Percentage of stools with normal consistency of each patient was calculated from normal consistency of stools by the patient per day. Mean percentage of stools with normal consistency in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12, for total patients was summarized.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||percentage of stools||Standard Deviation|Mean
1446569|NCT00880100|Secondary|Percentage of Patients With Normal Stool Frequency|Normal stool frequency was defined as having less than 4 bowel movements per day in baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and 5-day collection period of the Treatment Phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|"The ITT population included all patients who signed an ICF and started the baseline phase. Here n signifies patients who were evaluable for each specified category."|||percentage of patients||95% Confidence Interval|Number
1446570|NCT00880100|Primary|Percentage of Patients With Control of Steatorrhea|Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected at baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and during the 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.|A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)|The Intent-to-treat (ITT) population included all patients who signed an informed consent form (ICF) and started the baseline phase. The 50th percentile imputation method was used for missing data.|||percentage of patients||95% Confidence Interval|Number
1446571|NCT00880087|Other Pre-specified|Neurological Abnormality Scores (for Participants Who Survive)||Measured at Month 12|||||||
1446572|NCT00880087|Secondary|Neuropsychological Scores (for Participants Who Survive)|Functioning, as assessed by the Mullen Early Learning Composite (for children age < 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.|Measured at Month 12|Randomized children alive at one year with neuropsychological score available.|||Participants|||Count of Participants
1446573|NCT00880087|Secondary|Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest|Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome. Since higher levels of VABS-II represent a better outcome, a larger decline (large negative magnitude of change) in VABS-II score from baseline to one year represents a worse outcome.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|All randomized subjects with available data for this outcome (this implies a child must be either dead at 1 year, have the lowest possible value for the VABS-II score at 1 year, or if neither of these two criteria applies, must have both baseline VABS-II and 1-year VABS-II scores available to allow calculation of change in VABS-II score)|||Participants|||Count of Participants
1446574|NCT00880087|Secondary|Survival|Survival at one year after cardiac arrest|Measured at one-year anniversary of cardiac arrest.|All randomized patients with available vital status (alive or deceased) at one year after cardiac arrest.|||Participants|||Count of Participants
1446575|NCT00880087|Primary|Survival With Good Neurobehavioral Outcome|Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest. Higher values of VABS-II represent a better outcome.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|Subjects with baseline VABS-II >= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.|||Participants|||Count of Participants
1446576|NCT00880048|Secondary|Change From Baseline in the MSFQ Total Score in Females|MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.|Baseline and up to Week 6|All Subject Population (female). Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1446683|NCT00879645|Primary|Thiosulfate in Plasma|Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.|8 hours after treatment||||ng/mL||Standard Deviation|Mean
1446577|NCT00880048|Secondary|Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males|MSFQ included five items with a score ranging from 1 to 6 (1 = greater than normal; 2 = normal; 3 = minimally diminished; 5 = markedly diminished; and 6 = totally absent). The following areas of sexual functioning were included: diminished/absent libido; arousal difficulties; orgasm difficulties/anorgasmia; erectile dysfunction (males only) and degree of sexual satisfaction. A total score was used as a global measure of sexual dysfunction. The Baseline MSFQ requested the participant reflect back over the past month. For the treatment period, the follow-up MSFQ requested the participant reflect back over the past week. Change from Baseline was the value at post-Baseline visit minus Baseline value.|Baseline and up to Week 6|All subjects Population (males). Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446578|NCT00880048|Secondary|Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)|The DESS scale consisted of 43 signs and symptoms, scored as ‘new symptom’, ‘old symptom but worse’, ‘old symptom but improved’ or ‘symptom not present/old symptom but unchanged’. The total number of new signs and symptoms, old symptoms but worse, old symptoms but improved and the total number of new or old-but-worse signs and symptoms were calculated for each treatment and visit. n = number of subjects who had at least one of the 43 symptoms in the specified category. The summary for a specified category are of the number of symptoms the n subjects had in that category. Treatment period was up to Week 6.|Up to 17 days post-treatment|All subjects Population. Only those participants available at the specified time points were analyzed.|||Number of Incidences||Standard Deviation|Mean
1446579|NCT00880048|Secondary|Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)|Assessment of suicidality were done through use of the CSSRS for suicidal ideation and suicidal behavior. For suicidal ideation ratings were 1 to 5, where 1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation without intent to act, 4. Active suicidal ideation with any methods (not plan) without intent to act, 5. Active suicidal ideation with specific plan and intent and for suicidal behavior ratings were 6 to 12, Where 6. Actual attempt, 7. Engaged in non-suicidal self-injurious behavior, 8. Interrupted attempt, 9. Aborted attempt, 10. Preparatory acts or behavior, 11. Suicidal behavior, 12. Completed suicide. n= number participants with at least one CSSRS assessment after the first dose of study medication (i.e. on treatment or post treatment). Only those categories from CSSRS (1-12) are presented for which symptoms were actually observed in the participants. Categories with null values for all the arms have not been presented.|Up to 17 days post-treatment|The All Subjects Population was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1446580|NCT00880048|Secondary|Number of HAM-D Remitters|A HAMD remitter was defined as a participant who had a HAMD Total Score <=7. The HAMD total score was calculated for each participant at each time point. Those participants with no missing value for HAMD total score were categorized as having a HAMD total score of <=7 or >7.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1446581|NCT00880048|Secondary|Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446582|NCT00880048|Secondary|Change From Baseline in the MSQ Number of Nocturnal Awakenings|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and upto Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Number of awakenings||Standard Error|Least Squares Mean
1446583|NCT00880048|Secondary|Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset|The MSQ was a self-rated scale designed to assess effects on sleep and effects on next day functioning. The following variables were assessed in order to determine effects on sleep: total sleep time, sleep onset latency, number of nocturnal awakenings, wake time after sleep onset and sleep quality (from poor, assigned a score of 1, to excellent, assigned a score of 10). The refreshing value of the sleep was also determined (poor assigned a score of 1, to excellent, assigned a score of 10). Value at randomization was the Baseline value. Change from Baseline was calculated for each domain separately. Change from Baseline was the difference between score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||minutes (min)||Standard Error|Least Squares Mean
1446614|NCT00879970|Secondary|Number of Participants With a Fracture|Fracture is defined as a medical condition in which there is a break in the continuity of the bone. Fractures are defined as those breaks that are self reported plus confirmed by an X-ray. Data regarding all occurrences of any fracture were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446584|NCT00880048|Secondary|Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score|CPFQ was a brief self-report scale which was designed to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ comprised of 7 questions assessing each of the most common complaints of depressed participants reporting fatigue or cognitive/executive problems. Each question was rated on a scale of 1 to 6, with 1 indicating greater than normal functioning, 2, indicating normal functioning, and with higher numbers indicating poorer functioning. Two versions of the CPFQ were utilized during the study. The Baseline CPFQ requested the participant reflect back over the past month. For the treatment period, the CPFQ requested the participant reflect back over the past week. Value at randomization was the Baseline value. Change from Baseline in Total Score was the difference between CPFQ Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446585|NCT00880048|Secondary|Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI-S assessed scores range from 1 – Very much Improved to 7 – Very much worse, with 0 representing a participant that was not assessed. For the CGI-S, remote, blinded MedAvante, raters assessed the participant’s severity of illness considering their total clinical experience with the particular population being studied and information obtained during the Baseline HAMD interview with the participant. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between CGI-S Score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446586|NCT00880048|Secondary|Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score|The CGI-I assessed scores range from 1 – Very much Improved to 7 – Very much worse, with 0 representing a participant that was not assessed. The assessed scores were dichotomized. Scores of 1 or 2 was in the first category, scoring 1. All other scores (except zero which was regarded as missing) was in the second category, scoring 0. The percentage of participants in the first category was calculated for each assessment.|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1446587|NCT00880048|Secondary|Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)|The anxiety score was extracted from the HAM-D-17 and comprises of items 10, 11, 12, 13 and 15 from the HAM-D scale. The anxiety score was calculated by summing the individual response scores to these questions. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 18 (most severe measure of depression). Due to the small number of items, missing data was not imputed for the anxiety score. If either of the anxiety items was missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in anxiety score was the difference between the anxiety score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446588|NCT00880048|Secondary|Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score|QIDS-SR assessed symptoms severity of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criterion for major depressive disorder. It consisted of 16 separate items, defining 9 DSM-IV symptom criterion domains. A total score was obtained by summing scores on each domain. The lowest possible score was 0, which represented an absence of depression; the highest possible score was 27, which represented the most severe measure of depression. Due to the small number of items, missing data was not imputed for the QIDS-SR total score. If any of the 9 domains above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in total score was the difference between QIDS total score at the time point being analyzed to randomization. If no post- randomization scores were available, change from Baseline was set to missing.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446589|NCT00880048|Secondary|Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D Scale)|The BECH scale was extracted from the HAMD-17 and comprised the 6 items (sum of items 1, 2, 7, 8, 10, and 13 of the 17-item HAM-D scale): Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic and Somatic Symptoms General. The BECH Total Score was calculated by summing the individual response scores. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The lowest possible score was 0 (absence of depression) and the highest possible score was 22 (most severe measure of depression). Due to the small number of items , missing data was not imputed for the BECH Total Score. If any of the 6 items above were missing, the total score was not calculated at that visit. Value at randomization was the Baseline value. Change from Baseline in BECH Total Score was the difference between BECH Total Score at the time point being analyzed to randomization.|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446590|NCT00880048|Secondary|Number of Participants Who Maintained Clinical Response by Week 6|The start of the ‘maintained antidepressant response’ was the time at which a participant demonstrates a 50% reduction from randomization in their HAM-D total score and where this response was maintained until the end of the treatment phase (week 6). Participants who met the 50% reduction at week 6 without having met it at week 4 were considered to have reached a maintained response, and therefore were censored at week 6. Where a participant met the criteria for maintained antidepressant response, the “time (in days) to maintained antidepressant response” was calculated as: (Date of assessment at which the maintained response commences minus Date of randomization) plus 1. Where a participant did not met the criteria for maintained antidepressant response, their time to response was censored at the last on-treatment assessment they undertake, up to and including the week 6 assessment.|Up to Week 6|ITT Population.|||Participants|||Number
1446591|NCT00880048|Secondary|Percentage of Participants With a >=50% Reduction From Baseline in HAM-D Total Score|"HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. The HAM-D Total Score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was carried forward and used in the calculation of the change from randomization value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Data was presented as percent of HAM-D responders which was defined as participants who has a >=50% reduction from randomization in HAM-D total score."|Up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1446592|NCT00880048|Primary|Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score|"HAM-D was use to measure the severity of depressive symptoms in participants with primary depressive illness. It was a checklist of items that were ranked on a scale of 0-4 or 0-2. Items with quantifiable severity were scored 0 (lowest severity) to 4 (greatest severity); The HAM-D total score was calculated by summing the individual response scores. The lowest possible score was 0 (absence of depression) and the highest possible score was 52 (most severe measure of depression). For the last observation carried forward analyses, the most recent post randomization total score (as opposed to individual responses) was carried forward and used in the calculation of the change from randomization (Baseline) value. If the responses to more than 1 question were missing for a participant at a particular time point, the total score was not calculated. Change from Baseline in total score was the difference between HAM-D total score at the time point being analyzed and randomization."|Baseline and up to Week 6|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
1446593|NCT00880022|Secondary|Symptom Improvement|Lymphedema Symptom and Intensity Scale-Arm measures 30 symptoms yes no over the past 7 days . Total yes items added for number of symptoms.|Before first treatment and end of all treatments|Number of participant symptoms|||Number of participant symptoms||Inter-Quartile Range|Median
1446594|NCT00880022|Primary|Arm Volume at End of Study|measured by tape and then volume was calculated.|end of scheduled treatments-day 30 of treatment|Study withdrawals were not included.|||ml||Inter-Quartile Range|Median
1446595|NCT00880009|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446596|NCT00880009|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446597|NCT00880009|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1; 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446598|NCT00880009|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 24, 52, 2-6 weeks after the last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446599|NCT00880009|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446600|NCT00880009|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 36 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446601|NCT00880009|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446615|NCT00879970|Secondary|Number of Participants With Clinical Proteinuria|Clinical proteinuria is defined as a laboratory detection of urinary protein excretion > 0.5 grams (g) per 24 hours; spot urine analysis for albumin:creatinine ratio >=300 milligrams/g; timed urine collection for albumin excretion >=200 µg/minute or >=300 mg/24 hours. Clinical proteinuria data were obtained from outcomes reported by the site.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446602|NCT00880009|Secondary|Progression-Free Survival (PFS) Based on Investigator|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for PD), or from AE data (where the outcome was Death). PFS assessed by investigator was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446603|NCT00880009|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Part 1 Baseline up to 28 days after the last dose|Safety population included all participants who receive at least 1 dose of study treatment.|||percentage of participants|||Number
1446604|NCT00880009|Primary|Progression-Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PFS assessed by independent radiologist was to be reported."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1446605|NCT00879996|Secondary|Self-reported Illicit Opioid Use||6 months||||number of participants|||Number
1446606|NCT00879996|Secondary|Numerical Rating Score for Functioning|We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.|6 months|The participants who completed the treatment were included in the statistical analysis.|||units on a 0-10 point NRS scale||Standard Deviation|Mean
1446607|NCT00879996|Secondary|Numerical Rating Score for Pain|Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.|6 months|Participants that completed the treatment at 6 months were analyzed.|||units on a 0-10 NRS scale||Standard Deviation|Mean
1446608|NCT00879996|Primary|Number of Participants Retained in Treatment|This outcome assesses the number of participants who completed the treatment after 6 months.|6 months|All participants that were randomized were analyzed regarding their retention in treatment at 6 months.|||participants|||Number
1446609|NCT00879970|Secondary|Mean Score on Montreal Cognitive Assessment (MoCA) Test, as an Assessment of Cognitive Function (CF)|CF was assessed with the 30-point (pt) MoCA test, involving a short-term memory recall task (T) (5 pts), a clock-drawing T (3 pts), a 3-dimensional cube copy (1 pt), a trail-making B T (1 pt), a phonemic fluency T (1 pt), a 2-item verbal abstraction T (2 pts), an attention T (1 pt), a serial subtraction T (3 pts), digits forward/ backward (1 pt each), a 3-item confrontation naming T (3 pts), repetition of 2 syntactically complex sentences (2 pts), and orientation to time/ place (6 pts). A score of 26 or above is normal.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
1446610|NCT00879970|Secondary|Mean Score on Euro-QoL (EQ)-5D|"Quality of life (QoL) was assessed by using the Euro-QoL (EQ)-5D, a short questionnaire used for measuring health-related QoL. The preference weights are elicited by asking participants to place hypothetical health states on a visual analogue scale from 0 to 1, whereby a score of 1 represents the best health state imaginable and 0 represents a health state equivalent to being dead. Negative states are those worse than being dead."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
1446611|NCT00879970|Secondary|Number of Participants With Erectile Dysfunction|Erectile dysfunction (ED) is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual performance. ED was assessed by using the International Index of Erectile Dysfunction (IIED) questionnaire. This standardized and validated 15-item self-evaluation scale provides pre- and post-treatment clinic evaluations of erectile and orgasmic function, sexual desire, satisfaction with sexual intercourse, and general satisfaction.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
1446612|NCT00879970|Secondary|Number of Participants With Cognitive (Mental Processes) Decline (CD) From Baseline to the Year 2 Visit and the Final Visit|CD is equivalent to a difference of >=1.5 units on the Digit Symbol Substitution Test (DSST) score. The DSST is a neuropsychological test sensitive to brain damage, a serious loss of cognitive ability, age, and depression. It consists of digit-symbol pairs, followed by a list of digits. Under each digit the participant was asked to write the corresponding symbol as quickly as possible. The number of correct symbols within the allowed time (90 or 120 seconds) was measured in units (one correct score equals one unit).|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population. Study participation was placed on full clinical hold before data could be collected for this endpoint.||||||
1446613|NCT00879970|Secondary|Number of Participants With Hepatic Enzyme Increased or Abnormal Liver Function Tests|"Liver function tests are groups of clinical biochemistry laboratory blood assays designed to give information about the health of the liver. Liver function test abnormal and hepatic enzyme increased were obtained from adverse event data as reported by investigators based on the reference range of the reporting local laboratory methodology. The vitamin D arm was not analyzed for this outcome measure."|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446635|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).||Baseline up to Month 7||||percentage of participants|||Number
1446616|NCT00879970|Secondary|Number of Participants With Severe Lower Than Normal Blood Glucose Level (Hypoglycemia)|Severe hypoglycemia is defined as hypoglycemia requiring assistance from another person with either a documented plasma glucose <=36 mg/deciliter (2.0 millimole per liter [mmol/L]) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration. Hypoglycemia data were obtained from outcomes reported by the site. Data regarding hypoglycemia were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446617|NCT00879970|Secondary|Number of Participants With Retinopathy Requiring Laser Therapy, a Decline in Estimated Glomerular Filtration Rate (eGFR), Vitrectomy, and Renal Replacement Therapy|Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data on the number of participants with all of these microvascular outcomes were collected at each visit. Data regarding the number of participants with these microvascular outcomes were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446618|NCT00879970|Secondary|Number of Participants With Composite Microvascular Outcome|The components of the composite microvascular outcome are retinopathy, decline in eGFR, vitrectomy, and renal replacement surgery. Retinopathy is defined as damage to the inner lining of the eye (retina). Decline in eGFR is defined as a >=30% reduction in kidney function. Vitrectomy is a surgery to remove some or all of the fluid (vitreous humor) from the eye. Renal replacement therapy includes all the life-supporting treatments for renal failure. Data regarding the number of participants with changes in micro blood vessels (composite microvascular outcome) were collected at each visit.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446619|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Congestive Heart Failure (CHF), Shortness of Breath, Pneumonia, or Angina|CHF is a condition in which the heart is not able to pump adequate blood to meet the body's needs. Shortness of breath is defined as difficulty in breathing. Pneumonia is an infection of the lungs, caused by various microorganisms. Angina is defined as severe chest pain due to lack of adequate blood supply of the heart muscle because of obstruction/spasm of the heart's blood vessels. Data regarding the need for hospitalization due to any of these reasons were adjudicated by the EAC and sent to the IDMC on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446620|NCT00879970|Secondary|Number of Participants With Need for Hospitalization for Any Reason|Data regarding the need for hospitalization for any reason were collected and were then forwarded to the independent data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446621|NCT00879970|Secondary|Number of Participants With Any Revascularization|Revascularization is defined as any surgical procedure for the provision of a new, additional, or augmented blood supply to heart muscle. Data regarding the need for any revascularization were adjudicated by the EAC and sent to the data monitoring committee (IDMC) on a regular basis for unblinded review.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446622|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Outcome for Vitamin D|An EAC adjudicated all occurrences of the components of the composite outcome for vitamin D. Components are the first occurrence of death or cancer requiring hospitalization, treatment with medicines (chemotherapy), or surgery.|From Randomization at Visit 3 to Final Visit (up to 162 days)|ITT Population|||participants|||Number
1446623|NCT00879970|Primary|Number of Participants With the Indicated Components of the Composite Cardiovascular Outcome for Thiazolidinedione (TZD)|An event adjudication committee (EAC) adjudicated all occurrences of the components of the composite cardiovascular (CV; related to heart) outcome for TZD. Components are the first occurrence of cardiovascular death for which a non-heart-related cause has not been identified; non-fatal myocardial infarction (MI) (death of heart muscle from sudden blockage of a coronary artery by blood clot not leading to death); and non-fatal stroke (rapidly developing loss of brain function[s] due to disturbance in the blood supply to the brain not leading to death).|From Randomization at Visit 3 up to the Final Visit (average of 162 days)|Intent-to-Treat (ITT) Population: all randomized participants|||participants|||Number
1446624|NCT00879879|Secondary|6-minute Walk Test Results||1 year|||||||
1446625|NCT00879879|Secondary|Baseline/Transition Dyspnea Index||1 year|||||||
1446626|NCT00879879|Secondary|Total Lung Capacity by Plethysmography||1 year|||||||
1446627|NCT00879879|Secondary|Diffusion Capacity of Carbon Monoxide (DLCO)||1 year|||||||
1446628|NCT00879879|Primary|Stable or Improved Forced Vital Capacity (FVC) Response at 1 Year|"Forced vital capacity (FVC) must be >= 50% at baseline. Stable FVC response is defined as a -5% change in FVC from baseline up to a +5% change from baseline.~Improved FVC response is defined as 5% or greater increase in the predicted value of FVC on pulmonary function testing following 12 months of treatment."|1 year||||participants|||Number
1446629|NCT00879814|Secondary|Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)||Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3||||titers||95% Confidence Interval|Geometric Mean
1446630|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).||Baseline up to Month 7||||percentage of participants|||Number
1446631|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).||Baseline up to Month 7||||percentage of participants|||Number
1446632|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).||Baseline up to Month 7||||percentage of participants|||Number
1446633|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).||Baseline up to Month 7||||percentage of participants|||Number
1446634|NCT00879814|Primary|Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).||Baseline up to Month 7||||percentage of participants|||Number
1446660|NCT00879710|Primary|Changes in LDL Cholesterol|"Subjects with T1DM or T2DM were assigned to alternating therapy with simvastatin (40 mg) or ezetimibe (10 mg) for 6 weeks in a crossover design.~The data are reported as follows.~Subjects with type 1 diabetes mellitus:~Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)~Subjects with type 2 diabetes mellitus:~Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order)"|6 weeks after starting drug therapy||||mmol/L||Standard Error|Mean
1446661|NCT00879697|Primary|Total Walking Distance|The maximal walking distance|12 weeks||||meter||Standard Deviation|Mean
1446662|NCT00879684|Secondary|Number of Participants With Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.|Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)|Safety population included all enrolled participants in the study who received any study medication.|||participants|||Number
1446663|NCT00879684|Secondary|Number of Samples From Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||samples|Participants||Number
1446664|NCT00879684|Secondary|Number of Participants With Anti-CVX-060 Antibodies||Baseline (Day 0) up to 42 days after last dose|Anti-drug antibodies (ADA) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||participants|||Number
1446665|NCT00879684|Secondary|Recommended Phase 2 Dose (RP2D): Stage 1|RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.|Baseline (Day 0) up to 42 days after the last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.|||(mg/kg)/week|||Number
1446666|NCT00879684|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||hours||Full Range|Median
1446667|NCT00879684|Secondary|Apparent Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||(mL/hr)/kg||Standard Deviation|Geometric Mean
1446668|NCT00879684|Secondary|Apparent Volume of Distribution (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||milliliter per kilogram (mL/kg)||Standard Deviation|Geometric Mean
1446669|NCT00879684|Secondary|Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]|AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1446670|NCT00879684|Secondary|Serum Decay Half-Life (t1/2)|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|PK analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||hours||Standard Deviation|Mean
1446671|NCT00879684|Secondary|Maximum Observed Serum Concentration (Cmax)||0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)|Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of CVX-060 and had PK data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1446672|NCT00879684|Primary|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|Baseline (Day 0) up to 30 days after last dose of study medication|Safety population included all enrolled participants in the study who received any study medication.|||participants|||Number
1446673|NCT00879645|Secondary|Exhaled Sulfide||Baseline through day 2|||||||
1446674|NCT00879645|Secondary|Creatinine Clearance||Baseline, Day 7|||||||
1446675|NCT00879645|Secondary|Biochemistry||Baseline, Days 1, 2, and 7|||||||
1446686|NCT00879619|Secondary|Time to Progression (TTP) by PSA Response and Disease Response|Defined as an absolute increase in PSA of at least 2 ng/ml. For subjects with measurable disease, Response Evaluation Criteria In Solid Tumors (RECIST) criteria will be used. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher's exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years|||||||
1446687|NCT00879619|Secondary|Duration of Response (DR)|Response rates will be expressed with two-sided exact binomial confidence intervals.|Up to 3 years|||||||
1446688|NCT00879619|Secondary|Rates of Tumor Response (ORR)|Response rates will be expressed with two-sided exact binomial confidence intervals. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher’s exact test. Associations between PSA response and tumor response will also be examined by Fisher’s exact test.|Every 2 months|||||||
1446689|NCT00879619|Primary|Prostate Specific Antigen (PSA) Response Rate|Defined by >= 30% decline in PSA from baseline for at least 3 months during study entry. Response rates will be expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. Associations between PSA response and tumor response will also be examined by Fisher’s exact test.|Baseline, every 3 weeks, at study termination, and then for 3 years|||||||
1446690|NCT00879411|Secondary|Overall Tolerability Scale|Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10|8 weeks||||units on a scale||Standard Deviation|Mean
1446691|NCT00879411|Primary|Efficacy (Change of Diastolic Blood Pressure)|Change from baseline in 24h diastolic blood pressure (BP) at week 8|baseline to 8 weeks||||mm Hg||Standard Deviation|Mean
1446692|NCT00879411|Primary|Efficacy (Change of Systolic Blood Pressure)|Change from baseline in 24h systolic blood pressure (BP) at week 8|baseline to 8 weeks|Intention to Treat (ITT)|||mm Hg||Standard Deviation|Mean
1446693|NCT00879398|Secondary|Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics|Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as “effective”. Baseline and treatment characteristics included: geriatric status (<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (<274 days and ≥274 days) .|At the end of study treatment|PP Population|||Percentage of Participants||95% Confidence Interval|Number
1446694|NCT00879398|Secondary|Participant Perception of Bladder Condition at the End of Study Treatment|Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.|Baseline and at the end of study treatment|PP Population|||Participants|||Number
1446695|NCT00879398|Secondary|Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment|The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.|||Number of Episodes per 24 Hours||Standard Deviation|Mean
1446696|NCT00879398|Secondary|Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment|The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.|||Number of Episodes per 24 Hours||Standard Deviation|Mean
1446697|NCT00879398|Secondary|Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment|The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.|Baseline and at the end of study treatment|PP Population; n refers to the number of participants with evaluable data.|||Number of Episodes per 24 Hours||Standard Deviation|Mean
1446698|NCT00879398|Primary|Investigator's Final Assessment of Effectiveness at the End of Study Treatment|The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).|At the end of study treatment|Per-Protocol (PP) Population: participants who had evaluable data and were eligible for the efficacy assessment of the approved indication. The method of last observation carried forward was used in the analysis of effectiveness endpoints.|||Percentage of Participants|||Number
1446699|NCT00879398|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.|From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.|Safety Analysis Set|||Percentage of Participants|||Number
1446700|NCT00879359|Secondary|Number of Participants With Adverse Events Grades 1-5|Toxicity and safety was monitored before every treatment cycle, during, and after treatment. Bevacizumab was discontinued if the following criteria was met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.|58 months||||participants|||Number
1446722|NCT00879229|Primary|Change From Baseline in Six-minute Walk Distance (6MWD).|The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.|Baseline to Week 16|Participants in the Full Analysis Set (randomized and received at least one dose of study medication) with evaluable data were analyzed.|||meters||Standard Error|Mean
1446701|NCT00879359|Secondary|Median Progression Free Survival of This Treatment Regimen in Patients With Advanced/Recurrent Endometrial Cancer.|Median progression free survival measured in months. Progression of disease is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of the target lesions, or a measurable increased in a non-target lesion, or the appearance of a new lesion.|58 months||||months||Full Range|Median
1446702|NCT00879359|Primary|Number of Participants With Progression Free Survival (PFS=Date of Progression of Disease or Death) at 6 Months Using Bevacizumab, Carboplatin, and Paclitaxel in Patients With Measurable Disease for Advanced/Recurrent Endometrial Cancer|Number of patients with progression free survival measured at 6 months. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of target lesions, or a measure increase in a non-target lesion, or the appearance of new lesions.|58 months||||Participants|||Count of Participants
1446703|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.|||ng/mL||Standard Deviation|Mean
1446704|NCT00879333|Secondary|Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5|Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.|Week 5|PK analyses were based on the safety population in patients with evaluable samples. Only valid pre-dose (Cmin) & Cmax everolimus samples were included. For patients who were unable to tolerate the protocol-specified dosing schedule, dose adjustments were allowed to keep the patient on study drug. Some patients had dose reductions to 5mg daily.|||ng/mL||Standard Deviation|Mean
1446705|NCT00879333|Secondary|Overall Response Rate (ORR)|ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Participants|||Number
1446706|NCT00879333|Secondary|Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1446707|NCT00879333|Secondary|Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores|The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss).|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1446723|NCT00879190|Secondary|Neonatal Clinical Sepsis (Early Onset)||Up to 6 weeks after delivery||||affected neonates|||Number
1446724|NCT00879190|Secondary|Composite Maternal Morbidity|Composite of maternal postpartum morbidity defined as any of the following outcomes: endometritis, clinical sepsis, pneumonia, blood transfusion or ileus.|Up to 6 weeks after delivery||||Participants|||Count of Participants
1446725|NCT00879190|Primary|Treatment Success Defined as Resolution of Fever by 24 Hours Postpartum|Proportion of patients in each arm experiencing treatment success defined as resolution of fever by 24 hours postpartum|Up to 24 hours after delivery||||Participants|||Count of Participants
1446708|NCT00879333|Secondary|Progression Free Survival (PFS)|Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1446709|NCT00879333|Primary|Overall Survival (OS)|The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.|2.5 years|The Full Analysis Set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum that they were assigned to at randomization.|||Months||95% Confidence Interval|Median
1446710|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.|6 months post-treatment||||units on a scale||Standard Error|Mean
1446711|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|3-month Post-treatment||||units on a scale||Standard Error|Mean
1446712|NCT00879255|Primary|Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)|The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.|Post-treatment (two-weeks following end of treatment)||||units on a scale||Standard Error|Mean
1446713|NCT00879229|Secondary|Change in QOL Score as Assessed by the St. George’s Respiratory Questionnaire (SRGQ)|The SRGQ is designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.|Baseline to Week 16|Insufficient data due to study termination||||||
1446714|NCT00879229|Secondary|Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)|Each SF-36 score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. An increase in score indicates an improvement in health state.|Baseline to Week 16|Insufficient data due to study termination||||||
1446715|NCT00879229|Secondary|Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted|DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination||||||
1446716|NCT00879229|Secondary|Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise|Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).|Baseline to Week 16|Insufficient data due to study termination||||||
1446717|NCT00879229|Secondary|Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.|Baseline to Week 16|Insufficient data due to study termination||||||
1446718|NCT00879229|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted|FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.|Baseline to Week 16|Insufficient data due to study termination||||||
1446719|NCT00879229|Secondary|Change From Baseline in WHO Functional Class|"WHO functional class rates severity of pulmonary hypertension, with 4 categories on a scale of 1 to 4 with the worst category being 4. Change is represented as an increase (+1: Improved), decrease (-1: Deteriorated), or no change (0: No change) on the scale."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.|||units on a scale|||Number
1446720|NCT00879229|Secondary|Transition Dyspnea Index (TDI)|"The change in TDI at Week 16 (end of blinded treatment) was evaluated. TDI measures the change from the baseline characteristic Baseline Dyspnea Index. The TDI range is -9 to +9 (worst to best; 0 = no change)."|Baseline to Week 16|Participants in the Full Analysis Set with evaluable data were analyzed.|||units on a scale||Standard Deviation|Mean
1446726|NCT00879034|Secondary|To Obtain Baseline Clinical and Laboratory Data so That Longer-term Measures of Efficacy Will be Achievable if Treatment Continues Beyond the 4-week Feasibility Study Period.|The number of participants from whom baseline clinical and Laboratory data was obtained.|4 weeks||||Participants|||Count of Participants
1446727|NCT00879034|Secondary|To Assay for the Inhibition of HDJ-2 Farnesylation in Peripheral Blood Leukocytes (PBL)||4 weeks|This data was not collected for this feasibility study. HDJ-2 assessment in these 5 patients was analyzed at the end of a different protocol, NCT00916747.||||||
1446728|NCT00879034|Secondary|To Assess the Pharmacokinetics of Lonafarnib in Patients With Progeria.||4 weeks|This data was not collected for this feasibility study. Pharmacokinetics assessment of lonafarnib in these 5 patients was analyzed at the end of a different protocol, NCT00916747.||||||
1446729|NCT00879034|Secondary|To Investigate Which Clinical and Laboratory Studies Are Needed to Monitor or Alter Therapy to Prevent Unacceptable Toxicity|The number of participants with abnormal CBC w/diff panel, LFTs, renal functions and lipid panels.|4 weeks||||Participants|||Count of Participants
1446730|NCT00879034|Secondary|To Describe Any Acute and Chronic Toxicities Associated With Treating Progeria Patients With the Combination of Zoledronic Acid, Pravastatin and Lonafarnib|Number of participants with acute and chronic toxicities associated with treating progeria patients with the combination of zoledronic acid, pravastatin and lonafarnib|4 weeks||||Participants|||Count of Participants
1446731|NCT00879034|Primary|The Primary Objective of This Study is to Evaluate the Feasibility of Administering Intravenous Zoledronic Acid, Oral Pravastatin and Oral Lonafarnib, to Patients With Progeria for a Minimum of 4 Weeks|Feasibility was assessed by determining the number of participants with adverse events occurring over the course of the 4 week study.|4 weeks|Results are reported for the 5 patients who completed the 4 weeks of therapy.|||Participants|||Count of Participants
1446732|NCT00878995|Secondary|1-year Survival|Number of participants who survived one year post study.|1 year post study|12 subjects started each group. 2 subjects withdrew after baseline from the testosterone group.|||Participants|||Count of Participants
1446733|NCT00878995|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks|Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).|7 weeks|20 subjects completed this questionnaire at this time point.|||scores on a scale||Standard Deviation|Mean
1446734|NCT00878995|Secondary|Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline|Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).|Baseline|19 subjects completed this questionnaire at this time point.|||scores on a scale||Standard Deviation|Mean
1446735|NCT00878995|Secondary|Mood as Measured by Profile of Mood States at 7 Weeks|"Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being not at all' and 4 being extremely. There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best)."|7 weeks|20 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
1446736|NCT00878995|Secondary|Mood Measured by Profile of Mood States at Baseline|"Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being not at all' and 4 being extremely. There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best)."|baseline|22 subjects completed this questionnaire at this time point.|||units on a scale||Standard Deviation|Mean
1446737|NCT00878995|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|7 weeks|20 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
1446738|NCT00878995|Secondary|Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline|21 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
1446757|NCT00878995|Secondary|Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446739|NCT00878995|Secondary|Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks|The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99|7 weeks|21 subjects completed this questionnaire at this time point.|||Units on a scale||Standard Deviation|Mean
1446740|NCT00878995|Secondary|Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline|The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.|baseline|20 subjects completed this questionnaire at this time point.|||units on a scale||Standard Deviation|Mean
1446741|NCT00878995|Secondary|Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks|Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.|7 weeks|24 subjects began the study, 2 were dis-enrolled, 22 subjects finished the study. All 22 subjects completed this outcome measure at 7 weeks.|||grams||Standard Deviation|Mean
1446742|NCT00878995|Secondary|Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline|Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit|baseline|24 subjects were able to complete this outcome measure at the baseline study visit.|||grams||Standard Deviation|Mean
1446743|NCT00878995|Secondary|Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446744|NCT00878995|Secondary|Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446745|NCT00878995|Secondary|Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446746|NCT00878995|Secondary|Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446747|NCT00878995|Secondary|Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446748|NCT00878995|Secondary|Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446749|NCT00878995|Secondary|Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446750|NCT00878995|Secondary|Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446751|NCT00878995|Secondary|Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446752|NCT00878995|Secondary|Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446753|NCT00878995|Secondary|Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446754|NCT00878995|Secondary|Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446755|NCT00878995|Secondary|Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446756|NCT00878995|Secondary|Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446869|NCT00877929|Secondary|SBP Response 140 at Eight Weeks|SBP < 140 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
1446758|NCT00878995|Secondary|Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446759|NCT00878995|Secondary|Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446760|NCT00878995|Secondary|Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446761|NCT00878995|Secondary|Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446762|NCT00878995|Secondary|Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446763|NCT00878995|Secondary|Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.|Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446764|NCT00878995|Secondary|Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446765|NCT00878995|Secondary|Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks|Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446766|NCT00878995|Secondary|Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.|Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446767|NCT00878995|Secondary|Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks|Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|7 weeks|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446768|NCT00878995|Secondary|Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline|Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.|Baseline|Blood was collected for this outcome from only 18 subjects.|||picogram/milliliter||Standard Deviation|Mean
1446769|NCT00878995|Secondary|Physical Activity Levels as Measured by the ActiGraph Accelerometer|Physical activity is reported as % time sedentary for the entire 7 week study.|through study completion,up to 7 weeks|Data from only 12 subjects is presented due to a compliance issue with wearing the activity monitoring belts. A threshold was set to determine if subject was wearing the belt as directed.|||% time sedentary||Standard Deviation|Mean
1446770|NCT00878995|Secondary|Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks|Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.|7 weeks|Only 19 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.|||kilo-calories per day||Standard Deviation|Mean
1446771|NCT00878995|Secondary|Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline|Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.|Baseline|24 subjects completed this outcome measure at the baseline visit.|||kilo-calories per day||Standard Deviation|Mean
1446772|NCT00878995|Secondary|Body Weight as Measured by Scale at 7 Weeks.|Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.|7 weeks|22 subjects completed this outcome measure at the 7 week time point. 24 subjects started the study, 2 subjects dis-enrolled after the baseline visit.|||Kilograms||Standard Deviation|Mean
1446773|NCT00878995|Secondary|Body Weight as Measured by Scale at Baseline|Body weight in kilograms as measured by a scale at the baseline visit.|Baseline|24 subjects began the study. Each subjects was able to complete this outcome measure at the baseline time point.|||Kilograms||Standard Deviation|Mean
1446774|NCT00878995|Secondary|Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.|7 weeks|Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.|||Watts||Standard Deviation|Mean
1446775|NCT00878995|Secondary|Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.|Baseline|24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.|||Watts||Standard Deviation|Mean
1446776|NCT00878995|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.|7 weeks|Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.|||Newton-Meters||Standard Deviation|Mean
1446777|NCT00878995|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.|Baseline|24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.|||Newton-Meters||Standard Deviation|Mean
1446778|NCT00878995|Primary|Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.|Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.|7 weeks|Reporting data for the 22 completing subjects only, since this data is reported as change over time.|||Percent change||Standard Deviation|Mean
1446779|NCT00878969|Primary|Interleukin-6 (IL-6)|IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.|baseline and 18 months|Based on our power calculations, we needed 210 subjects to complete the study to be able to detect an effect. Given that only 37 subjects completed the study (18% of goal), no formal analyses were performed. Specifically, data were not collected for this assessment for any of the participants enrolled in the study.||||||
1446780|NCT00878878|Primary|Observed the Change of Pulmonary Vascular Resistance (PVR) Measured by Wood Units Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the pulmonary vascular resistance (PVR) results, which was taken from the subject in Wood Units, taken at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The pulmonary vascular resistance (PVR) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.|||Wood Units||Standard Deviation|Mean
1446781|NCT00878878|Secondary|Recorded Any Adverse Events From the Optison and Control Solution (5% Dextrose) Used in Subjects With Normal and Elevated Pulmonary Artery Systolic Pressure (PASP. This is Per Sequence and Not a Cross-over Study.|"Observe subjects with normal pulmonary artery systolic pressure (PASP) and elevated pulmonary artery systolic pressure (PASP) as measured by any adverse events.~The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; 11 subjects that were Normal PASP and 19 subjects that were Elevated PASP.~This is per sequence and not a cross-over study."|During the injection and catheterization procedure, and for up to 24 hours post-injection|The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP). Subjects stratified by; Normal PASP and Elevated PASP.|||Adverse Events|||Number
1446782|NCT00878878|Primary|Observed the Change of Pulmonary Artery Systolic Pressure (PASP) Measured by Millimeters of Mercury (mm hg) Within Certain Time Periods. This is Per Sequence and Not a Cross-over Study.|Measurement of the Pulmonary artery systolic pressure (PASP) results, which were taken from the subject in millimeters of mercury; a unit of pressure (mm hg), at Baseline and at 2 minutes, 6 minutes and 10 minutes. This is per sequence and not a cross-over study.|Measurements recorded at Baseline, 2 minutes, 6 minutes and 10 minutes post contrast administration|The Pulmonary artery systolic pressure (PASP) results were taken at Baseline and at 2 minutes, 6 minutes and 10 minutes.|||mm Hg||Standard Deviation|Mean
1446783|NCT00878826|Secondary|Side Effect - Bruising||Enrollment through 6 weeks postpartum||||participants|||Number
1446784|NCT00878826|Secondary|Bleeding Events||Enrollment through 6 weeks postpartum||||participants|||Number
1446785|NCT00878826|Secondary|Thromboembolic Events||Enrollment through 6 weeks postpartum||||participants|||Number
1446786|NCT00878826|Primary|Peak Anti-Xa Level|Goal peak anti-Xa level is 0.2 to 0.4 u/ml. We compared peak drug levels between different dosing arms.|One measurement per trimester of pregnancy, up to 36 weeks||||u/ml||Standard Deviation|Mean
1446787|NCT00878800|Secondary|Belinostat t½|Measure the t½ of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.|||hours||Geometric Coefficient of Variation|Geometric Mean
1446788|NCT00878800|Secondary|Belinostat Cmax|Measure the Cmax of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1446789|NCT00878800|Secondary|Belinostat AUC (Time 0 to Last Measurement)|Measure the AUC of belinostat alone (Day 4 values) and in the presence of doxorubicin (Day 5 values) at the Maximum Tolerated Dose level: belinostat 1000 mg/m2 and doxorubicin 75 mg/m2|Cycle 1, Day 4 and Day 5, pre-infusion, at end of infusion and at 5 min, 15 min, 30 min, 1 h, 2 h, 2 h and 15 min, 2 h and 30 min, 3 h, 4 h, 6 h, 8 h and 24 h post infusion|The pharmacokinetic population consisted of all patients who were dosed and had evaluable pharmacokinetic data. Dose level belinostat 1000 mg/m² and belinostat 1000 mg/m² plus doxorubicin 75 mg/m² is presented.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1446870|NCT00877929|Secondary|SBP Control 130 at One Week|Mean seated SBP < 130 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
1446871|NCT00877929|Secondary|SBP Control 130 at Two Weeks|Mean seated SBP < 130 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
1446790|NCT00878800|Primary|Objective Response (CR and PR)|Measured by response rate using the RECIST (Response Evaluation Criteria in Solid Tumors) response criteria (response rate: Complete Response (CR) and Partial Response (PR)) following up to 6 cycles of treatment.|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.|||percentage of participants|||Number
1446791|NCT00878800|Primary|Dose Limiting Toxicity (DLT)|Dose Limiting Toxicity (DLT) of PXD101 and doxorubicin combination treatment|Throughout study||||Dose limiting toxicity|||Number
1446792|NCT00878800|Secondary|Disease Control Rate (CR or PR or SD)|The disease control rate, defined as best overall response of either objective response or stable disease (CR or PR or SD) following up to 6 cycles of treatment with confirmation according to the RECIST criteria|Throughout study, after every 2 cycles|The full-analysis set (FAS) comprises all patients enrolled in the study and receiving at least one dose of study drug, and for whom at least one tumor assessment was performed post baseline.|||percentage of participants|||Number
1446793|NCT00878800|Secondary|Time to Progression||Throughout study, after every 2 cycles|Includes only patients with disease progression.|||months||95% Confidence Interval|Median
1446794|NCT00878800|Secondary|Duration of Response||Throughout study, after every 2 cycles|Includes only patients with response|||Months||95% Confidence Interval|Median
1446795|NCT00878800|Secondary|Time to Response||Throughout study, after every 2 cycles|Includes all 41 patients in the FAS population. 37 patients were censored due to no response, 23 in the Dose Escalation group and 14 in the MTD Expansion group.|||months||Full Range|Median
1446796|NCT00878800|Primary|Maximum Tolerated Dose (MTD) of Doxorubicin|Maximum Tolerated Dose (MTD) of doxorubicin|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks||||mg/m2|||Number
1446797|NCT00878800|Primary|Maximum Tolerated Dose (MTD) PXD101|Maximum Tolerated Dose (MTD) of PXD101treatment|During Cohort 1 to 4, Cycle 1 only, up to 3 weeks||||mg/m²|||Number
1446798|NCT00878722|Secondary|Elimination t½||Cycle 1, Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d|||Hours||Standard Deviation|Mean
1446799|NCT00878722|Secondary|Belinostat AUC (Area Under Curve)||Cycle 1, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d|||ng*hrs/mL||Standard Deviation|Mean
1446800|NCT00878722|Secondary|Belinostat Cmax|Cmax: Arm A: at Cycle 1 Day 4, Cycle 1 Day 5 Arm B: Cycle 1 Day 1 and Cycle 1 Day 2|Samples taken in Cycle 1 only, prior to initial dose on days 4 and 5 and at end of infusion, 5, 15, and 30 min, and 1, 2, 3, 4, and 6 hours post infusion|Results shown for dose level 1000 mg/m2/d|||ng/mL||Standard Deviation|Mean
1446801|NCT00878722|Secondary|Remission Duration|Remission duration: time (weeks) from date of remission status to disease relapse.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Remission duration was reported among participants who reported response|||Weeks||95% Confidence Interval|Mean
1446802|NCT00878722|Secondary|Event-Free Survival|Event-free survival: time (weeks) from entry into study until treatment failure, disease relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle||||Weeks||95% Confidence Interval|Median
1446803|NCT00878722|Secondary|Relapse-Free Survival|Relapse-free survival: time (weeks) from leukemia-free state to relapse or death from any cause.|Throughout study, after each cycle for the first two cycles, then after every second cycle|Relapse free survival was reported among participants who reported response|||Weeks|||Number
1446804|NCT00878722|Secondary|Overall Survival|Overall survival: time in weeks from entry into study until death from any cause. All patients without this endpoint at the time of discontinuation or the end of trial have been censored.|Throughout study, after each cycle for the first two cycles, then after every second cycle||||Weeks||95% Confidence Interval|Median
1446805|NCT00878722|Secondary|Duration of Response (CR and PR)|Duration of Response (CR and PR) in Weeks|Throughout study, after each cycle for the first two cycles, then after every second cycle|All patients who received at least one dose of belinostat and/or idarubicin were included in the full analysis set (FAS). Duration of response was reported among participants who reported response|||weeks||Full Range|Mean
1446806|NCT00878722|Secondary|Time to Response (CR and PR)|Time to response: time in weeks from first treatment to obtainment of the particular response status (CR and PR)|Throughout study, after each cycle for the first two cycles, then after every second cycle|Time to response was reported among participants who reported response|||Weeks||95% Confidence Interval|Median
1446807|NCT00878722|Primary|Overall Response|Efficacy measured as Response rate (complete response ([CR] and Complete remission with incomplete recovery of platelets [CRi]) and partial response ([PR])) using the response criteria of the International Working Group (Cheson et al 2003). CR includes CRi, CRc (Cytogenetic complete remission), and CRm (Molecular complete remission).|Throughout study, after each cycle for the first two cycles, then after every second cycle||||participants|||Number
1446808|NCT00878722|Primary|Maximum Tolerated Dose, Dose Limiting Toxicity|DLT (dose limiting toxicities): patients with any of the toxicities: 1.Haematological toxicity is not included in the definition due to bone marrow involvement by the disease except for following grade 4 ANC (absolute neutrophil count) and PLT (platelet count) for 6 weeks with less than 5% blasts in bone marrow. 2.Drug related non hematological Grade 3 or 4 toxicity except alopecia, brief nausea and vomiting, diarrhea, rash, arthralgias and myalgias. Treatment interventions should palliate toxicity symptoms prior to concluding a DLT has occurred (e.g if nausea and vomiting to Grade 3 have been associated with the drug). If despite standard treatment Grade 3 nausea and or vomiting persisted then a DLT was considered to have occurred. Grade 4 diarrhea in spite of standard therapeutic measures was included in DLT definition. 3.Inability to tolerate full dosing cycle due to toxicity or any drug-related adverse event resulting in more than 14 day treatment delay in the next treatment cycle|First Cycle||||participants|||Number
1446809|NCT00878709|Secondary|Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2|Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray’s method (Gray,1988).|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
1446810|NCT00878709|Secondary|Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm|CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
1446811|NCT00878709|Secondary|Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
1446812|NCT00878709|Secondary|Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm|Time to distant recurrence is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
1446813|NCT00878709|Secondary|Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
1446814|NCT00878709|Secondary|Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm|Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
1446815|NCT00878709|Secondary|Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
1446816|NCT00878709|Secondary|Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm|Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
1446817|NCT00878709|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death from any cause|From time of randomization to death||2019-07-31|07/2019||||
1446818|NCT00878709|Primary|Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms||From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants||95% Confidence Interval|Number
1446819|NCT00878709|Primary|Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm|Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.|From randomization until time of event up to 2 years|Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.|||percentage of participants with events|||Number
1446820|NCT00878644|Secondary|Neuropsychological Scores (for Participants That Survive)|Functioning, as assessed by the Mullen Early Learning Composite (for children age < 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.|Measured at Month 12|Randomized children alive at one year with neuropsychological score available.|||Participants|||Count of Participants
1446821|NCT00878644|Secondary|Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest|Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|All randomized subjects with available data for this outcome (this implies a child must be either dead at 1 year, have the lowest possible value for the VABS-II score at 1 year, or if neither of these two criteria applies, must have both baseline VABS-II and 1-year VABS-II scores available to allow calculation of change in VABS-II score)|||Participants|||Count of Participants
1446822|NCT00878644|Secondary|Survival|Survival at one year after cardiac arrest|Measured at one-year anniversary of cardiac arrest.|All randomized patients with available vital status (alive or deceased) at one year after cardiac arrest.|||Participants|||Count of Participants
1446823|NCT00878644|Primary|Survival With Good Neurobehavioral Outcome|Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest.|Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date.|Subjects with baseline VABS-II >= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.|||Participants|||Count of Participants
1446824|NCT00878605|Primary|Hemoglobin A1C|% change HgbA1c from baseline to 12 weeks.|Baseline and Week 12|||||||
1446825|NCT00878553|Secondary|Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the plasma Half-Life (t1/2 in hours) of SKP-1041 zaleplon the each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA)for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||hour|Participants|Standard Error|Mean
1446826|NCT00878553|Secondary|AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC/Dose (ng*h/mL/mg) [Area under the concentration-time curve per Dose of SKP-1041 zaleplon] for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng*h/mL/mg|Participants|Standard Error|Mean
1446827|NCT00878553|Secondary|AUC Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the AUC (area under the concentration-time curve of SKP-1041 zaleplon) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics were calculated for AUC. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng x h/mL|Participants|Standard Error|Mean
1446828|NCT00878553|Secondary|Tmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Tmax (hour) (timepoint post-dose of maximum plasma zaleplon concentration) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||Hours post-dose|Participants|Standard Error|Mean
1446829|NCT00878553|Secondary|Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of Cmax/Dose (ng/mL/mg) (maximum plasma zaleplon concentration normalized per dose) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics, geometric means and 90% confidence intervals were calculated for dose-normalized values of Cmax. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng/mL/mg zaleplon|Participants|Standard Error|Mean
1446830|NCT00878553|Secondary|Cmax Pharmacokinetic (PK) Profile Characterization|"A detailed characterization of the Cmax (maximum plasma concentration of SKP-1041 zaleplon in ng/mL) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses.~Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis)."|Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)|Pharmacokinetic Population--Patients who completed night 3 of Visit 6 (the PK substudy). Note that these patients had participated in a crossover design across all doses for the sleep study but had PK assessments only for one dose (parallel group design).|||ng/mL|Participants|Standard Error|Mean
1446831|NCT00878553|Secondary|Visual Analog Scale (Sedation)|"Self-assessment of next morning sedation. Patients answered the question How alert do you feel? via a 100mm scale on which 0mm indicated very sleepy and 100mm indicated wide awake and alert.The VAS measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (in this case, sleepiness and alertness). Patients were asked to mark the point on the line that they felt represented their current state. The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked."|9 hours after tablet ingestion|Safety population (patients exposed to that given treatment)|||mm change from baseline||Standard Error|Mean
1446832|NCT00878553|Secondary|Digit Span Test|Assessment of next day residual cognitive effects via testing immediate recall of numbers. The patient was given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score was the number of correct responses, where the digits were repeated correctly. One point was given for each correctly repeated string of digits. The maximum subscore in the Digits Forward was 16, and the maximum subscore in the Digits Backward was 14, for a total score of 30.|9 hours post-dose|Intention to Treat population (all randomized patients)|||units on a scale change from baseline||Standard Error|Mean
1446833|NCT00878553|Secondary|Digit Symbol Substitution Test|Assessment of next-day residual cognitive effects. The Digit Symbol Substitution Test (DSST) explores attention and psychomotor speed. Given a code table displaying the correspondence between pairs of digits (from 1 to 9) and symbols, the patient filled in blank squares with the symbol that was paired with the digit displayed above the square. The patient was required to fill in as many squares as possible in 180 seconds.|9 hours after tablet ingestion|Intention to Treat population (all randomized patients)|||percentage change from mean baseline||Standard Error|Mean
1446834|NCT00878553|Secondary|Subjective Wake Time After Sleep Onset (sWASO)|Subjective wake time after sleep onset sourced from the Morning Sleep Questionnaire self-assessment|9 hours after tablet ingestion|All Efficacy Analyses were performed on the Intention to Treat (ITT) population (all randomized patients).|||minutes||Standard Error|Mean
1446835|NCT00878553|Secondary|Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)|Number of Awakenings After Sleep Onset during hours 3-7 post-dose (inclusive) as measured with PSG (polysomnography)|hours 3-7 (inclusive) post-dose|Intention to Treat dataset (all randomized patients)|||Number of awakenings||Standard Error|Mean
1446836|NCT00878553|Secondary|Total Sleep Time 3-7 Hours Post-dose|Total Sleep Time during hours 3-7 (inclusive) post-dose|hours 3-7 (inclusive) post-dose|Intention to Treat population (all randomized patients)|||Minutes||Standard Error|Mean
1446837|NCT00878553|Secondary|WASO 1-8|Wake Time After Sleep Onset, measured in minutes over the full 8 hour polysomnographic recording period, is summarized by treatment group for each night during the Screening and Treatment Periods.|Constantly throughout the 8 hour sleep period|Intention to Treat population|||Minutes||Standard Error|Mean
1446838|NCT00878553|Primary|Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)|Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.|Hours 3-7 (inclusive) after tablet ingestion|Efficacy analyses were performed on the Intention to Treat Population(all randomized patients).|||minutes||Standard Error|Mean
1446839|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score, 48 Hours Recall|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. It consists of a pain subscale (5 questions), function subscale (17 questions). and a stiffness subscale (2 questions). The total score was derived by calculating the mean of the VAS scores from all 24 questions with score scale ranging from 0 to 100, 0 being no pain, stiffness and difficulty in performing daily activities and 100 being extreme pain, stiffness and difficulty in performing daily activities.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
1446840|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Stiffness Subscale, 48 Hours Recall.|The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. The Stiffness subscale consists of 2 questions (Severity of stiffness after first awakening in the morning and severity of stiffnes after periods of inactivity later in the day). WOMAC stiffness was derived by calculating the mean of the VAS scores from the 2 questions with score scale ranging from 0 to 100, 0 being no stiffness and 100 extreme stiffness.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
1446841|NCT00878501|Secondary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscale, 48 Hours Recall.|The WOMAC VA 3.1. is a self-administered electronic questionnaire that assesses pain, stiffness and disability related to OA. The Function (daily activities) subscale consists of 17 questions. WOMAC function was derived by calculating the mean of the VAS scores from the 17 questions with scores ranging from 0 to 100, 0 = no difficulty in performing daily activities and 100 = extreme difficulty.|Baseline, Week 2 and Week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
1446842|NCT00878501|Primary|Mean of Week 2 and Week 4 Changes From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale, 48 Hours Recall.|The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.|Baseline, week 2, week 4.|Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.|||mm||95% Confidence Interval|Least Squares Mean
1446843|NCT00878436|Secondary|Number of Patients That Achieve a 50% or Greater PSA Decline by 9 Months of Therapy|Unable to locate PI for secondary outcome measure results. Data is not available.|9 months|Unable to locate PI for secondary outcome measure results. Data is not available.||||||
1446844|NCT00878436|Secondary|Time to PSA Progression|PSA progression is defined as a 25% or greater increase in PSA and an absolute increase value of 2 ng/ml or more over a nadir or baseline documented and confirmed by a second value three weeks later|up to 2 years|Unable to locate PI for secondary outcome measure results. Data is not available.||||||
1446872|NCT00877929|Secondary|SBP Control 130 at Four Weeks|Mean seated SBP < 130 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
1446873|NCT00877929|Secondary|SBP Control 130 at Six Weeks|Mean seated SBP < 130 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
1446845|NCT00878436|Primary|Percentage of Patients Free of Progression and Without Symptomatic Deterioration|"measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression.~Only participants who completed two or more treatment cycles were assessed for this outcome measure."|6 months||||percentage of participants|||Number
1446846|NCT00878436|Primary|Percentage of Patients Free of Progression and Without Symptomatic Deterioration|"measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression.~Only participants who completed two or more treatment cycles were assessed for this outcome measure."|9 months||||percentage of Participants|||Number
1446847|NCT00878228|Secondary|Impact of Nausea and Vomiting on Quality of Life|Percentage of participants whose quality of life was impacted by nausea and vomiting|Postdischarge Day 1||||percentage of participants|||Number
1446848|NCT00878228|Secondary|Severity of Nausea|Percentage of participants reporting moderate or severe nausea in the first 24 hours|Postdischarge Day 1||||percentage of participants|||Number
1446849|NCT00878228|Primary|Incidence of Nausea|Percentage of participants with nausea|Postdischarge Day 1||||percentage of participants|||Number
1446850|NCT00878215|Primary|The Number of Participants Who Have Complete Ablation According to Early Post-ablative Imaging Studies as Well as no Recurrence of the Tumor Within 6 Months (Phase 4 Portion of the Study)|-A successful endpoint will be a 90% success rate of complete ablation according to early post-ablative imaging studies as well as no recurrence of the tumor within 6 months.|6 months post-ablation|The study closed early as the imaging-guidance system became commercially available as the Explorer Liver Image Guided System and the Explorer Liver Passive Tracking device.||||||
1446851|NCT00878215|Primary|Target Accuracy of an Ablation Probe Using Image-guided Surgery Technology as Measured by the Number of Participants Who Had Ablation Burns Within a 5mm Radius of the Tumor Centroid (Phase 3 Portion of Study)|-A measurement of the ablation probe placement via the burn zone will be performed by pathology via specimen sectioning.|Completion of surgery|The study closed early as the imaging-guidance system became commercially available as the Explorer Liver Image Guided System and the Explorer Liver Passive Tracking device.||||||
1446852|NCT00878215|Primary|Accuracy With Which Image-guided Surgery (IGS) Can be Used to Implant a Ceramic Bead Inside a Tumor as Measured by Successful Deliveries of the Bead to Within 8mm of the Pre-operatively Planned Target Point (Phase 2 Portion of Study)|"Calculation of bead delivery accuracy using the IGS system involves the acquisition of images of the resected specimen and then the co-registration of the post-resection images to the pre-operative image set. Given that the target location is marked in the pre-operative image set and the registration calculation allows an overlay of the two image sets a Euclidean distance error can be calculated between the true bead location and the pre-operatively determined target. Given that the error involved in computing the registration between the two image sets is included within the bead delivery target error calculation it is imperative that the impact of registration error is minimized.~Numbers represented are the distance between the planned target site and the true bead location"|Completion of surgery|10 patients were excluded as they were determined to be ineligible after enrollment but prior to surgery.|||mm|||Number
1446853|NCT00878215|Primary|Number of Participants Who Have a Successful Intraoperative Registrations (Phase 1 Portion of Study)|"10 successful intraoperative registrations with no more than 30% failure rate over all the cases will be considered a successful endpoint~A successful registration is defined as one which yields an RMS surface residual of ≤ 10 mm and is determined to be success after qualitative evaluation."|Completion of surgery|2 patients were excluded due to the fact that liver surface data was not acquired for these cases due to equipment malfunctions and not due to a failure in the guidance method in general.|||participants|||Number
1446854|NCT00877929|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)|Change from baseline in UACR (measured in spot urine) after eight weeks of treatment|8 weeks|Treated set|||ratio||Standard Deviation|Mean
1446855|NCT00877929|Secondary|DBP Response at Week One|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 1|Treated set|||participants|||Number
1446856|NCT00877929|Secondary|DBP Response at Week Two|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 2|Treated set|||participants|||Number
1446857|NCT00877929|Secondary|DBP Response at Week Four|Mean seated DBP <80 mmHg or a reduction of >=10 mmHg|Week 4|Treated set|||participants|||Number
1446858|NCT00877929|Secondary|DBP Response at Six Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|week 6|Treated set|||participants|||Number
1446859|NCT00877929|Secondary|DBP Response at Eight Weeks|Mean seated DBP<80 mmHg or a reduction of <=10 mmHg|Week 8|Treated set|||participants|||Number
1446860|NCT00877929|Secondary|SBP Response 130 at One Week|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
1446861|NCT00877929|Secondary|SBP Response 130 at Two Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
1446862|NCT00877929|Secondary|SBP Response 130 at Four Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
1446863|NCT00877929|Secondary|SBP Response 130 at Six Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
1446864|NCT00877929|Secondary|SBP Response 130 at Eight Weeks|SBP <130 mmHg or a reduction >=10 mmHg|Baseline, week 8|Treated set using LOCF|||participants|||Number
1446865|NCT00877929|Secondary|SBP Response 140 at One Week|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 1|Treated set using LOCF|||participants|||Number
1446866|NCT00877929|Secondary|SBP Response 140 at Two Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 2|Treated set using LOCF|||participants|||Number
1446867|NCT00877929|Secondary|SBP Response 140 at Four Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 4|Treated set using LOCF|||participants|||Number
1446868|NCT00877929|Secondary|SBP Response 140 at Six Weeks|SBP <140 mmHg or a reduction >=10 mmHg|Baseline, week 6|Treated set using LOCF|||participants|||Number
1446891|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 2||||mmHg||Standard Error|Least Squares Mean
1446892|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 4||||mmHg||Standard Error|Least Squares Mean
1446893|NCT00877929|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 6||||mmHg||Standard Error|Least Squares Mean
1446894|NCT00877929|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8|Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.|Baseline, week 8|Treated Set includes all randomized participants who took at least one dose of treatment|||mmHg||Standard Error|Least Squares Mean
1446895|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events|The minor hypoglycemia category included events in which symptoms consistent with hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.|||rate per subject-year||Standard Error|Mean
1446896|NCT00877890|Secondary|Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events|The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject.|Day 1 to Week 24|ITT Population. Analysis was done for SU ITT patients (ITT patients taking SU) and Non-SU ITT patients separately.|||rate per subject-year||Standard Error|Mean
1446897|NCT00877890|Secondary|Ratio of Triglycerides at Week 24 to Baseline|Ratio of triglycerides (measured in mg/dL) at Week 24 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||ratio||Standard Error|Least Squares Mean
1446898|NCT00877890|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 24|Change in HDL from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1446899|NCT00877890|Secondary|Change in Total Cholesterol From Baseline to Week 24|Change in total cholesterol from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1446900|NCT00877890|Secondary|Change in Sitting Diastolic Blood Pressure From Baseline to Week 24|Change in diastolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
1446901|NCT00877890|Secondary|Change in Sitting Systolic Blood Pressure From Baseline to Week 24|Change in systolic blood pressure from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mmHg||Standard Error|Least Squares Mean
1446902|NCT00877890|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||kg||Standard Error|Least Squares Mean
1446903|NCT00877890|Secondary|Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL|Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1446904|NCT00877890|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|Change in fasting plasma glucose from baseline (Day 1) to Week 24.|Day 1, Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
1446905|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <=6.5%|Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1446906|NCT00877890|Secondary|Percentage of Subjects Achieving HbA1c Target of <7%|Percentages of subjects achieving HbA1c target value of <7% at Week 24.|Week 24|ITT Population. Missing data up to Week 24 were imputed using LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.|||percentage of subjects|||Number
1448151|NCT00866034|Other Pre-specified|Endocrine Profile in the Early, Mid and Late Follicular Phase.|"difference in endocrine profile between the 2 arms during the mid and late follicular phase~influence of early elevated follicular phase progesterone levels on clinical outcome"|2 years|||||||
1446907|NCT00877890|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c from baseline (Day 1) to Week 24 [Week 24 - Baseline].|Day 1, Week 24|The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 24 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1446908|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 108 to Month 120||||Subjects|||Number
1446909|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 96 to Month 108||||Subjects|||Number
1446910|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 84 to Month 96||||Subjects|||Number
1446911|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 72 to Month 84|Analysis was performed on the Month 84 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 84 time point.|||Subjects|||Number
1446912|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 60 to Month 72|Analysis was performed on the Month 72 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 72 time point.|||Subjects|||Number
1446913|NCT00877877|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Month 48 to Month 60|The analysis was performed on the Month 60 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 60 time point.|||Subjects|||Number
1446914|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.|||Subjects|||Number
1446915|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 120|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1446916|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 108|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.|||EL.U/ML||95% Confidence Interval|Geometric Mean
1446917|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.|At Month 108|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.|||Subjects|||Number
1446918|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1446919|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1446920|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1446921|NCT00877877|Primary|Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers|Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1446922|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 96|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.|||Subjects|||Number
1446923|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 84|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.|||Subjects|||Number
1446924|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 72|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.|||Subjects|||Number
1446925|NCT00877877|Primary|Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.|"Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.~Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.~A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.~A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination."|At Month 60|Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.|||Subjects|||Number
1446926|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment||8 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 8-16 hour time interval.|||mg||Standard Deviation|Mean
1446927|NCT00877799|Other Pre-specified|Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment||4 to 8 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 4-8 hour time interval.|||mg||Standard Deviation|Mean
1446928|NCT00877799|Secondary|Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment||0 to 16 hours|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.|||mg||Standard Deviation|Mean
1446929|NCT00877799|Primary|Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint|The primary efficacy endpoint was the percentage of treatment responders compared to placebo. A responder was defined as a subject who had at least a 40% reduction in their pain intensity score and a pain relief score of “some,” “a lot,” or “complete” at 15 and 30 min following the start of the study drug infusion.|15 and 30 minutes after study drug administration|Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.|||responders|||Number
1446930|NCT00877773|Primary|Tumor Response|For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).|Baseline to Disease Progression (restaged at 8 weeks and at 4 months)|Of the 44 participants enrolled, only 30 were evaluable for response.|||participants|||Number
1446938|NCT00877604|Primary|The Proportion of Responder Patients in the Two Treatment Groups According the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)-R Slope.|Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R slope during the treatment period as compared to the lead-in period.|1 year||||participants|||Number
1446939|NCT00877487|Primary|Percent of Treatment Failures at up to 6 Weeks|Treatment failure defined as > or equal to 50% increase in the ADHD-RS with adult prompts total score and a > or equal to 2 point increase in the CGI-S score.|Up to 6 weeks|Full Analysis Set (FAS) defined as all subjects who were randomized and received at least 1 dose of investigational product.|||Percent of participants|||Number
1446940|NCT00877487|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at up to 6 Weeks|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Up to 6 weeks|FAS|||Percent of Participants|||Number
1446941|NCT00877487|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 6 Weeks|The ADHD-RS consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Up to 6 weeks|FAS|||Units on a scale||Standard Error|Least Squares Mean
1446942|NCT00877448|Primary|Treatment-related Adverse Events|Number of treatment-related adverse events per cohort|Day 0 until day 42 (termination visit)||||number of reported events|||Number
1446943|NCT00877448|Primary|Adverse Events|Number of adverse events per cohort|day 0 until day 42 (termination visit)||||number of reported events|||Number
1446944|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1446945|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1446946|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1446947|NCT00877383|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1446948|NCT00877383|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|End of the study (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1446949|NCT00877383|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1446950|NCT00877370|Primary|Ertapenem Transmembrane Clearance by Continuous Hemodialysis.||24 hours after receiving first 1 gram dose|All participants were included in the analysis.|||mL/min||Standard Deviation|Mean
1448152|NCT00866034|Secondary|Cumulative Ongoing Pregnancy Rate||2 years||||cumulative ongoing pregnancy rate (%)|||Number
1446951|NCT00877071|Secondary|The Local Effects of the LC BeadTM in the Explanted Liver of Those Patients Who go on to Receive Liver Transplantation||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
1446952|NCT00877071|Secondary|Symptomatic and Quality-of-life Measures in Patients Treated With the LC BeadTM||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
1446953|NCT00877071|Secondary|The Objective Tumor Response Rate in Patients With HCC Treated With LC BeadTM Using EASL and RECIST Criteria||36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
1446954|NCT00877071|Primary|The Number of Patients in the Cohort Effectively Downstaged to Transplant Eligibility With the LC BeadTM|Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to both a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant as well as those individuals within Milan criteria as an attempt to maintain their eligibility.|36 months|The data was not analyzed due to insufficient enrollment. A total of 2 patients were enrolled during the course of the study. Both patients experienced disease progression; one patient following Treatment #1 and the other after Treatment #3.||||||
1446955|NCT00877058|Primary|Self Rated Health|"Self rated health was measured by the question In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed"|1 year|ITT|||participants|||Number
1446956|NCT00877058|Primary|Number of Partipants Measured Frail at 1-year Follow up|Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition|1 year|ITT was used. The basic assumption was that older adults (80+) deteriorate over time in the natural course of the aging process. The imputation method chosen was to replace missing values with a value based on the Median Change of Deterioration (MCD) a conservative form of worst case between baseline and follow-up.|||participants|||Number
1446957|NCT00877058|Primary|Dependence in Two or More Activities of Daily Living (ADL)|"ADL stair case:~Independence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0–9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed"|1 year||||participants|||Number
1446958|NCT00877032|Secondary|Number of Participants With Anti-Drug Anti-body|Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||participants|||Number
1446959|NCT00877032|Secondary|Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)|AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 165|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||nanogram*hr/mL (ng*hr/mL)||Standard Deviation|Mean
1446960|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PD analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||hours||Full Range|Median
1446961|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)||Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacodynamic (PD) analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
1446962|NCT00877032|Secondary|Plasma Terminal Half-life (t1/2) of RN6G|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||days||Standard Deviation|Mean
1446963|NCT00877032|Secondary|Mean Residence Time (MRT) of RN6G|MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||days||Standard Deviation|Mean
1446964|NCT00877032|Secondary|Clearance (CL) of RN6G|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||mL/hr/kg||Standard Deviation|Mean
1446965|NCT00877032|Secondary|Volume of Distribution (Vd) of RN6G|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||mL/kilogram (mL/kg)||Standard Deviation|Mean
1446966|NCT00877032|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.|||hours||Full Range|Median
1446967|NCT00877032|Secondary|Maximum Observed Plasma Concentration (Cmax) of RN6G|Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.|||mcg/mL||Standard Deviation|Mean
1446968|NCT00877032|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|PK analysis population included all participants who received any amount of the single dose of RN6G.|||mcg*hr/mL||Standard Deviation|Mean
1446969|NCT00877032|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.|Pre-dose on Day 1; 1 hour (hr) during infusion on Day 1; 0, 1, 4, 8, 12 hrs post-dose on Day 1; Day 2, 7, 14, 21, 28, 42, 56, 84, 168|Pharmacokinetic (PK) analysis population included all participants who received any amount of the single dose of RN6G. Here “N” (number of participants analyzed) signifies participants evaluable for this measure.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
1446970|NCT00877032|Primary|Incidence and Severity of Systemic Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||participants|||Number
1446971|NCT00877032|Primary|Incidence and Severity of Ocular Adverse Events (AEs)|AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant’s usual function), moderate (interfered to some extent with participant’s usual function) and severe (interfered significantly with participant’s usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.|Baseline up to Day 168|Safety analysis population included all participants who received any amount of the single dose of either study drug or placebo.|||participants|||Number
1446972|NCT00877006|Secondary|Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period|Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications.|Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period|Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.|||Participants|||Count of Participants
1446973|NCT00877006|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients|||months||95% Confidence Interval|Median
1446974|NCT00877006|Secondary|Kaplan-Meier Estimate for Duration of Response (DOR)|DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause.|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients with complete response (CR) or partial response (PR)|||months||95% Confidence Interval|Median
1446975|NCT00877006|Secondary|Kaplan-Meier Estimate for Event-free Survival (EFS)|"EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.~Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier."|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients|||months||95% Confidence Interval|Median
1446976|NCT00877006|Secondary|Kaplan-Meier Estimate for Progression-free Survival (PFS)|PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first.|Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)|Randomized patients|||months||95% Confidence Interval|Median
1448153|NCT00866034|Primary|Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle.||2 years||||Cumulative live birth rate (%)|||Number
1446977|NCT00877006|Secondary|Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period|"Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):~Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.~In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.~>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis~other conditions as specified in the protocol"|Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period|Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.|||Participants|||Count of Participants
1446978|NCT00877006|Secondary|Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)|EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life.|Day 1 (prior to treatment), 32 weeks|The set of randomized participants (intent-to-treat) consisting of all patients randomly assigned to treatment, and who had data at both timepoints.|||units on a scale||Standard Deviation|Mean
1446979|NCT00877006|Secondary|Therapeutic Classification of Concomitant Medications||32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.|||participants|||Number
1446980|NCT00877006|Secondary|Therapeutic Classification of Prior Medications||prior to start of treatment|Safety Analysis Set: all participants randomly assigned to a treatment group|||participants|||Number
1446981|NCT00877006|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period|Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status).|Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and with baseline and post-baseline values.|||participants|||Number
1446982|NCT00877006|Secondary|Potentially Clinically Significant Abnormal Weight|Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant.|Baseline, Week 32|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen with a baseline and post-baseline weight.|||participants|||Number
1446983|NCT00877006|Secondary|Clinically Significant Abnormal Vital Signs||32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and had baseline and post-baseline values.|||participants|||Number
1446984|NCT00877006|Secondary|Worst Overall CTCAE Grade for Hematology Laboratory Test Results|Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had an assessment.|||participants|||Number
1446985|NCT00877006|Secondary|Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results|Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles).|32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had a post-baseline assessment.|||participants|||Number
1446986|NCT00877006|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period|AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one’s ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event.|32 weeks|Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.|||participants|||Number
1446999|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 36.|||g/dL||Standard Deviation|Mean
1446987|NCT00877006|Secondary|Percentage of Participants With Overall Response at End of Treatment Period|Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1446988|NCT00877006|Primary|Percentage of Participants With Complete Response (CR) at End of Treatment Period|CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies.|6 to 8 21 or 28-day cycles (18-32 weeks)|Evaluable Analysis Set: treated participants with a baseline and >=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging [CT/MRI] or positron emission tomography [PET] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
1446989|NCT00876928|Secondary|Disposition Index|Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better|Baseline, 3, 6, 9, 12 months|modified intent to treat|||Unitless||Standard Deviation|Mean
1446990|NCT00876928|Primary|Percent of Subjects Who Develop Diabetes|Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl|one year|Minorities with pre-diabetes and hypovitaminosis D|||percentage of participants|||Number
1446991|NCT00876915|Secondary|The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TAT at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TAT|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||ug/L||Standard Deviation|Mean
1446992|NCT00876915|Secondary|The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of FVIIa at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of FVIIa|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||pM||Standard Deviation|Mean
1446993|NCT00876915|Secondary|The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of TFPI at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of TFPI|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||pg/mL||Standard Deviation|Mean
1446994|NCT00876915|Secondary|The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Human F12 at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of Human F12|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||ng/mL||Standard Deviation|Mean
1446995|NCT00876915|Secondary|The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of D-Dimer at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients|baseline value of D-Dimer|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||ug/mL||Standard Deviation|Mean
1446996|NCT00876915|Secondary|The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients|Blood samples were obtained to measure the value of Tissue Factor at baseline compared between high risk for VTE and low risk for VTE ambulatory cancer patients.|baseline value of tissue factor|From 98 high risk patients, 89 provided blood samples used for this analysis. From the low risk group, all 101 subjects provided blood samples for analysis.|||pg/mL||Standard Deviation|Mean
1446997|NCT00876915|Primary|Percentage of Patients Who Experienced Clinically Significant Bleeding Events.|The percentage of patients who experienced a clinically significant bleeding event were recorded (including major and clinically significant non-major bleeding) over 13 weeks (12 weeks of study and an additional week of observation). Major bleeding was defined as being clinically overt and satisfying one of the following: decrease in hemoglobin of 2.0 g/dL, leading to transfusion of 2 or more units of blood or packed red cells, occurring in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leading to death. Clinically significant non-major bleeding was defined as clinically overt, not meeting criteria for major bleeding and with one of the following characteristics: multiple-source, spontaneous hematoma > 25 cm², epistaxis > 5 mins, macroscopic hematuria not related to instrumentation, spontaneous rectal bleeding, gingival bleeding > 5 mins, hemoptysis, hematemesis or prolonged bleeding (> 5 minutes) after venipuncture.|13 weeks||||percentage of participants|||Number
1446998|NCT00876915|Primary|Percentage of Patients With Venous Thromboembolisms|The percentage of patients who developed a Venous thromboembolism were recorded within 12 weeks following randomization including all adjudicated occurrences of symptomatic DVT, PE and upper extremity thrombus as well as all asymptomatic DVT and PE detected by lower extremity ultrasonography and chest CT.|12 weeks||||percentage of participants|||Number
1448183|NCT00865189|Secondary|Number of Cycles of Chemotherapy||Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7|ITT population|||cycles||Standard Deviation|Mean
1447000|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
1447001|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 36.|||U/L||Standard Deviation|Mean
1447002|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 36 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for AST at baseline and at month 36.|||U/L||Standard Deviation|Mean
1447003|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 36 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for ALT at baseline and at month 36.|||U/L||Standard Deviation|Mean
1447004|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1447005|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1447006|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1447007|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1447008|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 36 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 36.|||mg/dL||Standard Deviation|Mean
1447009|NCT00876733|Secondary|Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline|The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Haemoglobin at baseline and at month 12.|||g/dL||Standard Deviation|Mean
1447010|NCT00876733|Secondary|Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline|The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Creatinine at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
1447011|NCT00876733|Secondary|Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline|The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Gamma GT at baseline and at month 12.|||U/L||Standard Deviation|Mean
1447012|NCT00876733|Secondary|Changes in the Laboratory Data (AST) After 12 Months From Baseline|The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for AST at baseline and at month 12.|||U/L||Standard Deviation|Mean
1447013|NCT00876733|Secondary|Changes in the Laboratory Data (ALT) After 12 Months From Baseline|The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for ALT at baseline and at month 12.|||U/L||Standard Deviation|Mean
1448184|NCT00865189|Secondary|Number of Cycles of Induction Chemotherapy||6 cycles (12 weeks; cycle length = 14 days)|ITT population. Only Arm A participants received induction treatment.|||cycles||Standard Deviation|Mean
1447014|NCT00876733|Secondary|Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline|The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Blood Glucose at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
1447015|NCT00876733|Secondary|Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline|The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Triglycerides at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
1447016|NCT00876733|Secondary|Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for LDL Cholesterol at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
1447017|NCT00876733|Secondary|Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline|The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for HDL Cholesterol at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
1447018|NCT00876733|Secondary|Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline|The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.|Baseline and 12 months|Patients from TS with evaluable data for Total Cholesterol at baseline and at month 12.|||mg/dL||Standard Deviation|Mean
1447019|NCT00876733|Secondary|Changes in the CD4+ Cell Count After 36 Months From Baseline.|The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 36 months|Patients from FAS with values for CD4+ at baseline and after 36 months.|||cells/mm^3||Standard Deviation|Mean
1447020|NCT00876733|Secondary|Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.|The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.|Baseline and 12 months|Patients from FAS with values for CD4+ at baseline and after 12 months.|||cells/mm^3||Standard Deviation|Mean
1447021|NCT00876733|Secondary|Changes in the Viral Load After 36 Months From Baseline.|The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 36 months|Patients from FAS with values for viral load at baseline and after 36 months.|||Log10 copies/ml||Standard Deviation|Mean
1447022|NCT00876733|Secondary|Changes in the Viral Load After 12 Months From Baseline.|The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.|Baseline and 12 months|Patients from FAS with values for viral load at baseline and after 12 months.|||Log10 copies/ml||Standard Deviation|Mean
1447023|NCT00876733|Primary|Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs|Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs|36 months|Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.|||participants|||Number
1447024|NCT00876694|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks|Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates.|After 12, 24 and 52 weeks|The intention-to-treat (ITT) population included all randomized patients who received at least one dose of study drug.|||Liters||Standard Error|Least Squares Mean
1447025|NCT00876694|Primary|Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.|||mmol/L||Standard Error|Least Squares Mean
1447026|NCT00876694|Primary|Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52|The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.|4, 8, 12, 24, 36, 44, and 52 weeks|The safety population included all patients who received at least one dose of study drug.|||mmol/L||Standard Error|Least Squares Mean
1447027|NCT00876694|Primary|The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.~The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).~Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms."|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
1447187|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2|Solicited injection site reactions: Pain, Erythema, and Swelling.|0-7 Days Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.|||Participants|||Number
1447028|NCT00876694|Primary|The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.~A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
1447029|NCT00876694|Primary|The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment|"The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.~A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.~A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg."|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
1447030|NCT00876694|Primary|The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment|The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.|52 weeks|The safety population included all patients who received at least one dose of study drug.|||Participants|||Number
1447031|NCT00876460|Secondary|Cmax of Docetaxel in Course 2|"Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2.~Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1447032|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 2|"AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2.~Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol."|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (AUC0-inf could not be calculated in 1 patient because the elimination phase was not observed in plasma concentration-time profile in this patient.)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1447033|NCT00876460|Secondary|Cmax of Docetaxel in Course 1|Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. PK sampling of docetaxel for this patient was done and included in PK analysis.)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1447034|NCT00876460|Secondary|AUC0-inf of Docetaxel in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1|-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration|Treated set (1 patient was replaced after completion of first administration of docetaxel and before any nintedanib intake. Pharmacokinetic (PK) sampling of docetaxel for this patient was done and included in PK analysis.)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1447035|NCT00876460|Secondary|Cmax of Nintedanib in Course 1|Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1|-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1447036|NCT00876460|Secondary|AUC0-inf of Nintedanib in Course 1|AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1|-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1|Treated set (AUC0-inf could not be calculated in 5 patients because the elimination phase was not observed in plasma concentration-time profiles in these patients.)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1447037|NCT00876460|Secondary|Clinical Relevant Abnormalities in Laboratory Parameters|Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set|||Participants|||Number
1447038|NCT00876460|Secondary|Time to Treatment Failure (TTF)|"For participants with known date of discontinuation of the study treatment (or progression [not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression] or death): TTF [days] = earlier of date of discontinuation of the study treatment, progression, or death – date the study treatment started + 1.~For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) [days] = date when the patient is known to be progression-free and alive – date the study treatment started + 1.~Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set|||Days||95% Confidence Interval|Median
1447039|NCT00876460|Secondary|Progression-Free Survival (PFS)|"For participants with known date of progression or death (of any cause): PFS [days] = earlier of date of progression or death – date the study treatment started + 1.~For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) [days] = date of last imaging when the participant is known to be progression-free and alive – date the study treatment started + 1.~Progression is assessed according to RECIST version 1.0."|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Treated set|||Days||95% Confidence Interval|Median
1447215|NCT00874250|Secondary|Intensive Care Unit (ICU) Stay|Subjects admitted to ICU during index hospitalization|Initial Device Implant Index Hospitalization||||Participants|||Count of Participants
1447040|NCT00876460|Secondary|Disease Control|Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who treated with nintedanib and had both baseline and at least one post-treated tumour measurement by computed tomography (CT) image|||Participants|||Number
1447041|NCT00876460|Secondary|Objective Tumor Response|Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0|Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)|Patients who were treated with nintedanib and had both baseline and at least one post-treatment tumour measurement by computed tomography (CT) image|||Participants|||Number
1447042|NCT00876460|Primary|Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses|"Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.~The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE)."|Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days|Treated set|||Participants|||Number
1447043|NCT00876460|Primary|Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel|"Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel.~Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) <1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT."|During the first treatment course, up to 3 weeks|Treated set (Patients eligible for DLT confirmation)|||Participants|||Number
1447044|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
1447045|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
1447046|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
1447047|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
1447048|NCT00876447|Secondary|Change From Study Baseline in Volume Per Void|The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Milliliters (mL)||Standard Deviation|Mean
1447064|NCT00876018|Secondary|Change From Baseline in Folate Level After 4 Months|Folate level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||nanogram per mililitre (ng/mL)||Inter-Quartile Range|Median
1447216|NCT00874250|Secondary|Procedural Survival|Subjects who survived the index procedure|Initial Device Implant Procedure During Index Hospitalization||||Participants|||Count of Participants
1447049|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1447050|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1447051|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1447052|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1447053|NCT00876447|Secondary|Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Scores on a Scale||Standard Deviation|Mean
1447054|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 5|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1447065|NCT00876018|Secondary|Change From Baseline in Vitamin B12 Level After 4 Months|Vitamin B12 was measured by electrochemilumenesence method as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||picomole per litre(pmol/L)||Inter-Quartile Range|Median
1447055|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 4|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1447056|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 3|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1447057|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 2|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1447058|NCT00876447|Primary|Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).|Study Baseline, Week 6 Treatment Cycle 1|BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received|||Incontinence Episodes||Standard Deviation|Mean
1447059|NCT00876343|Secondary|Mean Change in Sheehan Disability Scale (SDISS)|"The endpoint evaluated the change in SDISS from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period.~The patient rates the extent to which his or her 1) work, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired)."|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration||||Rating score||Standard Error|Mean
1447060|NCT00876343|Secondary|MADRS Response Rate|The percentage of subjects with a decrease in MADRS total score of 50% or more, from the end of the SSRI/SNRI treatment period to the end of the placebo-controlled, double-blind treatment period (or withdrawal).|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration||||percentage of subjects|||Number
1447061|NCT00876343|Primary|Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The change in MADRS total score from the end of the SSRI/SNRI treatment period to Week 6 of the placebo-controlled, double-blind treatment period by covariance analysis, and compared the aripiprazole variable dose group with the placebo group as well as the aripiprazole fixed dose group with the placebo group.~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms~1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts"|Baseline (the end of the SSRI/SNRI treatment period), at completion of administration||||Rating score||Standard Error|Mean
1447062|NCT00876265|Primary|Adjusted (LS) Mean Change From Baseline in Wrinkle Severity Rating Scale (SRS) Score of Each Nasolabial Fold (NLF) as Determined by the Blinded Evaluator at Week 12.|The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.|Baseline and Week 12 of follow-up|The Full Analysis Set (FAS) population was the analysis population which was defined as all subjects who were randomized and received at least one injection of the study device to the nasolabial folds.|||Wrinkle Severity Rating Score (SRS)||Standard Error|Least Squares Mean
1447063|NCT00876018|Secondary|Change From Baseline in Vitamin C Level After 4 Months|Vitamin C level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||miligram per decilitre (mg/dL)||Inter-Quartile Range|Median
1447217|NCT00874250|Secondary|Time in Days to Return to Normal Daily Activities|This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.|Average time within one month window||||Days||Full Range|Median
1447066|NCT00876018|Secondary|Change From Baseline in Vitamin B6 Level After 4 Months|Vitamin B6 level was measured as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||nano mole per litre (nmol/L)||Inter-Quartile Range|Median
1447067|NCT00876018|Secondary|Change From Baseline in Vitamin B2 Level After 4 Months|Vitamin B2 level was measured by erythrocyte glutathione reductase coefficient (EGRAC) method as micronutrient markers in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||ratio||Inter-Quartile Range|Median
1447068|NCT00876018|Secondary|Change From Baseline in C-reactive Protein Level After 4 Months|C-reactive protein level was measured.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||mg/L||Inter-Quartile Range|Median
1447069|NCT00876018|Secondary|Change From Baseline in Soluble Transferring Receptors (sTr) After 4 Months|Soluble transferring receptors (sTr) was measured to assess the iron status of study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||miligram per litre (mg/L)||Inter-Quartile Range|Median
1447070|NCT00876018|Secondary|Change From Baseline in Ferritin Level After 4 Months|Ferritin level was measured to assess the iron status of study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||nanogram per mililitre (ng/mL)||Inter-Quartile Range|Median
1447071|NCT00876018|Secondary|Change From Baseline in Hemoglobin Level After 4 Months|Hemoglobin level was measured to assess the iron status in study participants.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||gram per decilitre (g/dl)||Inter-Quartile Range|Median
1447072|NCT00876018|Secondary|Change From Baseline in Rate of Decline of Muscle Strength After 4 Months|Rate of decline of muscle strength was assessed to measure the muscle endurance of forearm. Sustained isometric contraction of forearm flexors to 50% of maximal handgrip was measured using the Jamar hand dynamometer and was performed on the non-dominant arm. The participant was required to sustain a maximal contraction until the force dropped to 50% of its maximal value. Rate of decline of muscle strength was calculated as 50 percent of maximal value of contraction divided by time to fatigue (50%maximal value of contraction (MVC)/Time to fatigue).|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||kg/sec||Standard Deviation|Mean
1447073|NCT00876018|Secondary|Change From Baseline in Time to Fatigue After 4 Months|Time to fatigue is defined as the time in seconds taken for the handgrip to fall from maximal value to 50% of the maximal value. Time to fatigue was measured using Jamar hand dynamometer to assess the muscle strength. In this test, participants were required to sustain a maximal contraction until the force dropped to 50% of its maximal value.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||sec||Standard Deviation|Mean
1447074|NCT00876018|Secondary|Change From Baseline in Maximal Handgrip Strength for Dominant and Non-dominant Hand After 4 Months|Maximal handgrip strength was measured using a Jamar handgrip dynamometer in dominant and non-dominant arms. The width of the grip was noted during the pre-intervention assessment and kept constant for an individual during the subsequent post-intervention assessment. Muscle strength was recorded as the best (highest) value for the dominant and non-dominant sides as well as average value of the 3 measurements.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||kg||Standard Deviation|Mean
1447075|NCT00876018|Primary|Change From Baseline in Visual Reaction Time After 4 Months|Visual reaction time was assessed using a customized computer based programme. Participant was provided with a periodic random test visual stimulus among many other ‘non test’ stimuli. Participant was required to tap the space bar of the computer as fast as possible on the appearance of the test visual stimulus. Three test visual cues were provided at each sitting to allow for training effects. The shortest visual reaction time of the three visual cues was used in analyses.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||milliseconds (msec)||Standard Deviation|Mean
1447076|NCT00876018|Primary|Change From Baseline in Time Taken for 40 Meter (m) Sprint After 4 Months|A 40m sprint was used to assess speed with time taken to complete the sprint being recorded manually using a digital stopwatch. The moment any part of the designated participant’s body reached the marker level, the corresponding examiner stopped their watches and recorded the time for the sprint.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||seconds (Sec)||Standard Deviation|Mean
1447112|NCT00875485|Secondary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1447077|NCT00876018|Primary|Change From Baseline in Aerobic Capacity-shuttle Test (VO2peak) After 4 Months|Aerobic capacity(VO2peak) is defined as maximum rate of oxygen consumption attained on a particular exercise test. VO2peak was measured by 20m shuttle run test to assess aerobic & whole body endurance. In this test, participants were asked to move around one cone to another placed at 19m distance, reversing direction & in accordance with a pace dictated by sound signal, that got progressively faster at one minute intervals. The initial pace was set at 4.0 km/hr & with subsequent increases of 0.5 km/hr every subsequent minute. This test was conducted in groups (of at least 3 children per group). The shuttle was stopped when either the participant chose to stop because of exhaustion or when participant was > 1m away from cone at 2 consecutive paced signals. The number of shuttles at stoppage was noted. VO2peak was calculated as 31.025 + (3.325 x speed) – (3.248 x age). Speed is speed attained in previous level of shuttle, computed as speed (km/hr) = v + 0.5 x n/60; and age is in years.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||km/hr*years||Standard Deviation|Mean
1447078|NCT00876018|Primary|Change From Baseline in Maximal Aerobic Capacity (VO2max)- 12 Inch Step Test After 4 Months|Maximal aerobic capacity (VO2max) is defined as the maximum rate of oxygen consumption, measured during incremental exercise. VO2max was measured with the help of an externally placed 12-inch step test to assess the aerobic fitness/cardio-respiratory endurance of the study participants. In this test, participants were asked to step at 22 steps a minute for 3 minutes. The pulse rate was recorded manually, within 15sec of stopping the test. VO2max was calculated as (VO2 x HRmax) divided by HR observed, where HRmax = 220-Age in years. HRmax= maximum heart rate. VO2 is equal to (0.2 x Stepping Rate) + (2.4 x Step height x Stepping Rate) + 3.5 mL/kg/min. mL/kg/min.= milliliter per kilogram per minute.|Baseline, after 4 months|Analysis for this outcome was performed on all randomized population. Number of participants analyzed is the number of participants from the randomized population evaluated at specific time points for respective treatment arm.|||mL/kg/min.||Standard Deviation|Mean
1447079|NCT00875979|Secondary|Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Progression-free survival was defined as the time from randomization to first documented disease progression (PD) or death due to any cause within 30 days of the last treatment, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients.|||Months||95% Confidence Interval|Median
1447080|NCT00875979|Secondary|Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|Duration of objective response was defined as the time from initial response to disease progression (PD) or death from any cause. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease. Only patients with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
1447081|NCT00875979|Primary|Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)|A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.|Baseline through the end of the study (up to 2 years 3 months)|Treated population: All enrolled patients who had baseline measureable disease.|||Percentage of patients||95% Confidence Interval|Number
1447082|NCT00875836|Secondary|Marijuana Craving|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) – 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course.|8 Weeks||||units on a scale||95% Confidence Interval|Mean
1447083|NCT00875836|Secondary|Retention in the Study|Number of days subjects remained active in the study|participants were followed for twelve weeks||||Day||Inter-Quartile Range|Median
1447084|NCT00875836|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|Participants provided a once-weekly urine sample for twelve weeks||||percentage of UDS|Participants||Number
1447085|NCT00875810|Secondary|Intervertebral Disc Space||2 years|As this is an observational study not all patients had images available for each visit, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.|||millimiters||Standard Deviation|Mean
1447218|NCT00874250|Secondary|Total Length of Hospital Stay (Days)|Total days of hospital stay during the initial hospitalization for implantation of device|Total Duration of the Index Hospitalization||||Days||Full Range|Median
1447086|NCT00875810|Primary|Neck Disability Index (NDI) Score|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).~The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.~NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation."|2 years|As this is an observational study not all patients completed NDI questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.|||units on a scale||Standard Deviation|Mean
1447087|NCT00875810|Secondary|Duration of Pain Prior to Enrollment|Documentation of duration of pain prior to enrollment|Baseline visit||||percentage of patients with pain|||Number
1447088|NCT00875810|Primary|EQ-5D|"The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).~EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by “no problem” in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death."|2 years|As this is an observational study not all patients completed EQ-5D questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.|||units on a scale||Standard Deviation|Mean
1447089|NCT00875797|Secondary|6-month Survival|Six month follow up|6 month||||participants|||Number
1447090|NCT00875797|Secondary|Infection Rate at Participants in Both Groups|Number of infections that occured at participants during study.|participants were followed for the duration of ICU stay (average 3 weeks)||||number of infections|||Number
1447091|NCT00875797|Primary|Intestinal Permeability - Lactulose-mannitol(L/M)Test|"Measurement of intestinal permeability using lactulose-mannitol test (L/M test).~Intestinal permeability to sugars is an accurate test for detecting intestinal damage. Intestinal permeability of the epithelium to very small sugar molecules such as lactulose/mannitol may give useful information regarding the overall condition of the digestive tract.~Mannitol is absorbed transcellularly and lactulose has a paracellular route of absorption. Reduction in mannitol absorption shows reduced surface area and increased lactulose absorption indicates a leaky gut.~Lactulose and mannitol are given orally and later determined from the collected urine with HPTLC (high performance thin layer chromatography). The L/M ratio, as a result of lactulose-mannitol tests, is then calculated regarding urine lactulose and mannitol concentrations.~Thus, with the lactulose/mannitol test the intestinal permeability changes due to different reasons can be evaluated."|4 days after admission to intensive care unit||||L/M ratio||Standard Deviation|Mean
1447092|NCT00875706|Primary|Number of Participants in Pilot Interviews|This outcome measures the number of participants that participated in interviews that were conducted during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Interview group were analyzed for this outcome. The population included trainees and direct care workers.|||participants|||Number
1447093|NCT00875706|Primary|Number of Participants in Pilot Surveys|This outcome measures the number of participants that completed the survey during the pilot in order to assess the feasibility of conducting a larger study.|This outcome was assessed at the end of the 1 year pilot study.|Only participants in the Data Collection - Survey group were analyzed for this outcome. The population included trainees and direct care workers.|||participants|||Number
1447094|NCT00875706|Primary|Facility Implementation of Trainings|This measure assesses the number of participating facilities (4) that implemented trainings in their own facilities upon completion of our educational training intervention.|This outcome was assessed at the end of the 1 year pilot study.|This unit of measure for this outcome measure is at the facility level. There were 4 facilities (8 trainees) in total that began the training intervention.|||Facility|Participants||Number
1447095|NCT00875706|Primary|Completion of Training Intervention|This outcome measures the number of participants that fully completed the training intervention.|This outcome was assessed at the end of the 1 year pilot study.|The analysis population includes only participants who started the Train-the-Trainer intervention and therefore only participants in the Training Feasibility Arm/Group were analyzed for this outcome.|||participants|||Number
1447096|NCT00875615|Secondary|Number of Patients Achieving Clinical Benefit|Number of patients achieving complete or partial response according to RECIST criteria|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.|||participants|||Number
1447097|NCT00875615|Primary|Number of Subjects Experiencing Adverse Events|The number of subjects experiencing adverse events after receiving protocol therapy.|36 months|Of the 11 participants enrolled, 10 had results that were evaluable.|||participants|||Number
1447098|NCT00875589|Primary|Stability of Fixation|The ability to keep eye position fixed on a visual target, measured by the distance between the target and eye fixation point averaged over 20 sec.|During eye movement recording session (20 sec).|Although there were 15 participants in the Control arm, data were only analyzed for a cohort of 11 that were age-matched to the MTBI arm participants.|||degrees||Standard Deviation|Mean
1447113|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-off Value.|"Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).~Note: Since none of the subjects were seronegative for anti-HAV antibody concentration at the pre-challenge time point, subjects received only the HBV vaccine as the challenge dose."|Before (PRE) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
1447099|NCT00875563|Primary|Number of Participants With Treatment Success|"Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm.~A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair.~A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis."|6 months|Two patients were lost to follow-up and did not have CT data at 6 months. Patients treated with the Zenith® Fenestrated AAA Endovascular Graft was compared to propensity score matched patients treated with the Zenith® AAA Endovascular Graft (NCT00196092, link to 5-year study results provided).|||participants|||Number
1447100|NCT00875550|Secondary|Time to Successful Extubation||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Hours||95% Confidence Interval|Median
1447101|NCT00875550|Secondary|Time to First Dose of Rescue Medication for Sedation and Analgesia||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Hours||95% Confidence Interval|Median
1447102|NCT00875550|Secondary|Total Amount of Rescue Medication Required for Sedation and Analgesia While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Milligram||Standard Deviation|Mean
1447103|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is Out of the Target Sedation Range (UMSS <1 or >3) While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||hours||Full Range|Median
1447104|NCT00875550|Secondary|Absolute Time on Study Drug That the Subject is in a UMSS Range of 1 to 3 While Intubated||6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Hours||Full Range|Median
1447105|NCT00875550|Primary|Percentage of Subjects That do Not Require Rescue Midazolam (MDZ) for Sedation Based on Achieving and Maintaining a Target University of Michigan Sedation Scale (UMSS) Score of 1 to 3 While Intubated.|"Clinical Score Level of Sedation 0 Awake/Alert~Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.~Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.~Deeply sedated: Deep sleep, arousable only with significant physical stimulation.~Unarousable"|6 to 24 hours|Efficacy Evaluable Population: All subjects randomized to study medication and who received randomized DEX for at least 6 hours|||Percentage of subjects|||Number
1447106|NCT00875485|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|One month after the administration of the challenge dose (Month 0 to Month 1)|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
1447107|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = AE that prevented normal activity. Related = AE assessed by the investigator as causally related to the study vaccination.|During the 31-day (Day 0 to 30) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
1447108|NCT00875485|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (axillary temperature). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature > 39.5°C. Related = general symptoms which were assessed by the investigator as causally related to vaccination.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
1447109|NCT00875485|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1447110|NCT00875485|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL|Before (PRE) and one month after (POST) the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
1447111|NCT00875485|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Day 0 to Day 3) follow-up period after the challenge dose|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
1447114|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 15.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||Subjects|||Number
1447115|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 14.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||Subjects|||Number
1447116|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 13.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||subjects|||Number
1447117|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 12.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||subjects|||Number
1447118|NCT00875485|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs) or Hepatitis A or B Infection.|SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|Since the last long-term follow-up visit up to Year 11.|Analysis was performed on Long Term (LT) Total Cohort which included all subjects who returned at the current follow-up study and who belonged to the Total cohort in the primary study.|||subjects|||Number
1447119|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Equal to or Above the Cut-Off Value.|Anti-HAV antibody cut-off value assessed was >= 15 milli-International Units per milliliter (mIU/mL).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084.|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points.|||subjects|||Number
1447120|NCT00875485|Primary|Anti-HBs Anamnestic Response.|"Anamnestic response was defined as:~Anti-HBs antibody concentrations ≥ 10 mIU/mL at one month post-challenge dose in subjects seronegative at the pre-challenge time-points.~At least a 4-fold increase in anti-HBs antibody concentrations, at one month post-challenge dose in subjects seropositive at the pre-challenge time-points."|One month after the challenge dose.|Analysis was performed on Total Vaccinated cohort for challenge dose that included all subjects who received the challenge dose and for whom the immunogenicity data were available.|||Subjects|||Number
1447121|NCT00875485|Primary|Anti-HBs Antibody Concentrations|"Antibodys concentrations are expressed as Geometric Mean concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HBs seropositive subjects. Seropositive subjects are subjects with anti-HBs antibody concentrations >= 6.2 mIU/mL.~Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by CLIA."|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of a two-dose or a three-dose primary vaccination in study HAB-084.|Analysis was performes on subjects from the Long Term According-to-Protocol (LT ATP) cohort forimmunogenicity on anti-HBs seropositive subjects with available data at the specified time-points.|||mIU/mL||95% Confidence Interval|Geometric Mean
1447122|NCT00875485|Primary|Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above the Cut-Off Values|Anti-HBs antibody cut-off values assessed were >= 6.2 mIU/mL and >= 10 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis for years 11 to 13. Results of year 14 and year 15 were only analysed by ChemiLuminescence ImmunoAssay (CLIA).|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on subjects with available data at the specified time-points|||Subjects|||Number
1447123|NCT00875485|Primary|Anti-HAV Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on anti-HAV seropositive subjects. Seropositive subjects are subjects with anti-HAV antibody concentrations >= 15 mIU/mL.|At Year 11, 12, 13, 14 and 15 after the first vaccine dose of two-dose or three-dose primary vaccination in study HAB-084|Analysis was performed on subjects from the Long Term According-to-Protocol (LT ATP) cohort for immunogenicity on anti-HAV seropositive subjects with available data at the specified time-points.|||mIU/mL||95% Confidence Interval|Geometric Mean
1447183|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
1447124|NCT00875433|Secondary|Percentage Peak Trough Fluctuation (PTF)|PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||percentage of peak trough fluctuation||Geometric Coefficient of Variation|Geometric Mean
1447125|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,Cmax)|R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1447126|NCT00875433|Secondary|Accumulation Ratio of AUC Values (R_A,AUC)|R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
1447127|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|Subset of TS, restricted to patients with adequate protocol compliance, i.e. patients without important protocol violations.|||hours||Full Range|Median
1447128|NCT00875433|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1447129|NCT00875433|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14).|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14|TS.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1447130|NCT00875433|Secondary|Time From Dosing to the Maximum Concentration (Tmax)|tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.|||hours||Full Range|Median
1447131|NCT00875433|Secondary|Maximum Concentration (Cmax)|Cmax represents the maximum measured concentration of afatinib in plasma on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1447132|NCT00875433|Secondary|Area Under Curve 0-24 Hours (AUC0-24) on Day 1|AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1.|0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1|TS.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1447133|NCT00875433|Secondary|Highest CTC Grade for Adverse Events|Highest Common Terminology Criteria (CTC) grade for adverse events|First administration of trial medication until 28 days after last administration of trial medication|All patients from TS with adverse events|||Participants|||Number
1447134|NCT00875433|Secondary|Average Time-matched Heart Rate Change From Baseline to Day 14.|Average time-matched heart rate change from baseline to day 14.|The day before the first drug dose (baseline) and the day 14.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.|||bpm||Standard Error|Mean
1447135|NCT00875433|Secondary|Patients With Notable Findings in QT on Day 14|Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT>500 ms.|Day 14|All patients from TS with data for QTcF on day 14|||Participants|||Number
1447136|NCT00875433|Secondary|Average Time-matched QT Change From Baseline to Day 14|Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.|||ms||Standard Error|Mean
1447137|NCT00875433|Secondary|Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point|Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model.|Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose )|All patients in TS who had at least 1 time-matched pair of QT measurements available from either Day1 or Day 14 of treatment.|||ms||Standard Error|Mean
1447138|NCT00875433|Secondary|Patients With Clinically Relevant Findings in ECG on Day 14|Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14.|Day 14|All patients from TS with data for ECG on day 14|||Participants|||Number
1447139|NCT00875433|Secondary|Patients With Notable Findings in QTcF on Day 14|Notable findings are defined as a QTcF>500 ms or an increase in QTcF of >60ms.|Day 14|All patients from TS with data for QTcF on day 14|||Participants|||Number
1447140|NCT00875433|Secondary|Duration of Disease Control (DC)|Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.|||weeks||95% Confidence Interval|Median
1447141|NCT00875433|Secondary|Disease Control|Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.|||Participants|||Number
1447142|NCT00875433|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as time from start of treatment to death.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|TS.|||weeks||95% Confidence Interval|Median
1447143|NCT00875433|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|All patients from TS who progressed or died.|||weeks||95% Confidence Interval|Median
1447144|NCT00875433|Primary|Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14|Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib.|The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.|All patients in TS who had at least 1 time-matched pair of QT measurements available from baseline and from Day 14 of treatment.|||ms||Standard Error|Mean
1447145|NCT00875433|Primary|Objective Response (OR)|OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas).|Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.|||Participants with OR|||Number
1447146|NCT00875420|Primary|Percent Change in Composite Score Over Time|Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.|||Percent change from baseline||Standard Deviation|Mean
1447147|NCT00875420|Secondary|Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.|Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.|||Percent change from baseline||Standard Deviation|Mean
1447148|NCT00875420|Secondary|Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.|Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.|Day 29 minus baseline|The intent-to-treat (ITT) population is defined as all patients who received one or more doses of study drug. Based on patients who had a result on Day 29.|||Percent change from baseline||Standard Deviation|Mean
1447149|NCT00875420|Primary|Percent Change in Frequency of Hot Flashes Over Time|Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.|Week 4 minus baseline week|The intent-to-treat population is defined as all patients who received one or more doses of study drug.|||Percent change from baseline||Standard Deviation|Mean
1447150|NCT00875394|Primary|Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 weeks|Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.||||||
1447151|NCT00875329|Primary|Responses From the TBI Clinical Reminder|The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview.|April 2007 January 2012||||percentage of participants|||Number
1447152|NCT00875212|Primary|Minimum pH After 14 Days of Use of Dentifrice|measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).|14 days|The initial part of the work as a pilot study.|||pH||Standard Deviation|Mean
1447153|NCT00875212|Primary|Minimum pH|The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose.|at 1 minute (minimum fermenting pH) or at 7 minutes|The number of subjects were determined by a pilot study carried out in 3 volunteers. The study has a crossover design. Thus the 4 groups of dentifrices tested included the same subjects in a different time-measurement avoiding the influence of individual variables in the analysis.|||pH||Standard Deviation|Mean
1447154|NCT00875017|Secondary|Net Calcium Absorption|"Net Calcium Absorption (Lanthanum carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Lanthanum carbonate + meal minus Rectal effluent calcium after fasting).~Net Calcium Absorption (Sevelamer Carbonate period) = Calcium ingested in meal minus (Rectal effluent calcium after Sevelamer carbonate + meal minus Rectal effluent calcium after fasting).~Net Calcium Absorption (Meal only period) = Calcium ingested in meal minus (Rectal effluent calcium after meal only minus Rectal effluent calcium after fasting)."|10 hours post-dose|PD set|||mg||Standard Error|Least Squares Mean
1447155|NCT00875017|Secondary|Net Phosphorous Binding|"Net Phosphorous Binding (Lanthanum carbonate period) = Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after meal only.~Net Phosphorous Binding (Sevelamer carbonate period) = Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after meal only."|10 hours post-dose|PD set|||mg||Standard Error|Least Squares Mean
1447184|NCT00874549|Other Pre-specified|Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
1447219|NCT00874250|Secondary|Days of Convalescence Stay in an Intensive Care Unit|Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation|During the Index Hospitalization||||participants|||Number
1447156|NCT00875017|Primary|Net Phosphorous Absorption|"Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting).~Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting).~Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting)."|10 hours post-dose|Pharmacodynamic Set (PD) consists of subjects who provided all rectal effluent collections and completed all treatment periods. Subjects who vomited during any of the treatment periods were excluded from the PD set.|||mg||Standard Error|Least Squares Mean
1447157|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Healthy Participants.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
1447158|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Healthy Participants|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
1447159|NCT00874939|Secondary|Time Weighted Average of the Change From Baseline After Single Dose Administration of MK-0249, Measured by GMLT in Participants With Alzheimer's Disease.|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
1447160|NCT00874939|Primary|Time Weighted Average of the Change From Baseline After Single Dose Administration of Donepezil 5 mg or Placebo, Measured by Groton Maze Learning Test (GMLT) in Participants With Alzheimer's Disease|The GMLT measures executive function and spatial problem solving on a computer touch screen where participants learn a hidden pathway through a maze consisting of a 10 x 10 grid of tiles. The number of errors made for five consecutive trials at a single session is totaled, where lower number of errors indicates better performance. A change from baseline that is positive indicates improved function.|Baseline and 5-7 hours post-dose|Analysis was not performed due to termination of the study prior to randomization and treatment.||||||
1447161|NCT00874887|Secondary|Minimum Inhibitory Concentration (MIC) Range at Day 14|MIC range at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2. The MIC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
1447162|NCT00874887|Secondary|Minimum Inhibitory Concentration 90 (MIC90) at Day 14|The Minimum Inhibitory Concentration 90 (MIC90) is the minimum concentration required to inhibit the growth of 90% of microorganisms. The MIC90 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
1447163|NCT00874887|Secondary|Minimum Inhibitory Concentration 50 (MIC50) at Day 14|The Minimum Inhibitory Concentration 50 (MIC50) is the minimum concentration required to inhibit the growth of 50% of microorganisms. The MIC50 outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
1447164|NCT00874887|Secondary|Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14|Mutant Prevention Concentration (MPC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MPC is the lowest drug concentration which prevents growth of any colony of bacteria on the conjunctiva. The MPC outcome measure was not analyzed due to the low number of data points.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points.|||micrograms per milliliter (ug/mL)|||Number
1447165|NCT00874887|Primary|Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14|Percentage of subjects with strain resistance as determined by Minimum Inhibitory Concentration (MIC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2.|Day 14|The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. One patient in the Zymar® group did not have cultures performed at Day 14.|||Percentage of Subjects|||Number
1447220|NCT00874250|Secondary|Operative Blood Loss (mL)|Blood loss in mL during initial device implantation procedure|Initial Device Implant Procedure During Index Hospitalization||||mL||Standard Deviation|Median
1447166|NCT00874848|Secondary|Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review|"Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator.~If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date."|From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||months||95% Confidence Interval|Median
1447167|NCT00874848|Secondary|Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review|"The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||months||95% Confidence Interval|Median
1447168|NCT00874848|Secondary|Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review|"The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||participants|||Number
1447169|NCT00874848|Secondary|Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review|"The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||participants|||Number
1447170|NCT00874848|Secondary|Overall Survival (OS) in Each Study Arm Based on the Safety Population|Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.|From the time of randomization to death, subject being lost to follow-up or study completion|The safety population comprised all randomized subjects who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin.|||months||95% Confidence Interval|Median
1447185|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days Post-vaccination 2|Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.|||Titers||95% Confidence Interval|Geometric Mean
1447186|NCT00874549|Primary|Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2|Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|Day 0 to 7 Post-vaccination 2|Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.|||Participants|||Number
1447171|NCT00874848|Primary|Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review|"Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria.~The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a ‘confirmation’ response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines."|From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months|The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0.|||participants|||Number
1447172|NCT00874822|Primary|Obstructive Sleep Apnea|The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.|9 Months||||participants|||Number
1447173|NCT00874770|Other Pre-specified|Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results|Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.|From screening up to Week 12 (treatment period)|All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point|||participants|||Number
1447174|NCT00874770|Secondary|Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12|cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12|At Week 12|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1447175|NCT00874770|Secondary|Percentage of Participants With Early Virologic Response (EVR) at Week 12|EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.|At Week 12|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1447176|NCT00874770|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.|At Week 4|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1447177|NCT00874770|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12|eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.|A Weeks 4 and 12|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1447178|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|From Day 31 up to Week 24 of post treatment follow-up|All participants who received at least 1 dose of study drug. n=evaluable patients|||participants|||Number
1447179|NCT00874770|Other Pre-specified|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase|An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.|SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug|All participants who received at least 1 dose of study drug.|||participants|||Number
1447180|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2||Day 0 and 28 days post-vaccination|Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
1447181|NCT00874549|Post-Hoc|Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
1447182|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2||Day 0 and Day 28 Post-vaccination 2|Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.|||Titers||95% Confidence Interval|Geometric Mean
1447188|NCT00874549|Post-Hoc|Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.|||Titers||95% Confidence Interval|Geometric Mean
1447189|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2||28 Days post-vaccination 2|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
1447190|NCT00874549|Post-Hoc|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1||Day 28 Post-vaccination 1|Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
1447191|NCT00874549|Other Pre-specified|Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1||Day 0 and Day 28 Post-vaccination 1|Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.|||Titers||95% Confidence Interval|Geometric Mean
1447192|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2||Day 28 Post-vaccination 2|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.|||Percentage of Participants|||Number
1447193|NCT00874549|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.||Day 28 Post-vaccination 1|Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.|||Percentage of Participants|||Number
1447194|NCT00874549|Primary|Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.|Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.|0-7 days post-vaccination 1|Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.|||Participants|||Number
1447195|NCT00874510|Primary|Hours Slept on Overnight Extended Duty Call Shifts|Two sites were separately analyzed for Mean Sleep Time for both Year 1 and Year 2.|12 months||||hours|Participants|95% Confidence Interval|Mean
1447196|NCT00874497|Secondary|Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)|Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan.|||percentage of participants|||Number
1447197|NCT00874497|Secondary|Percentage of Participants With COPD Exacerbations by Group at Week 104|For the COPD exacerbations, baseline is defined as Randomization (Day 1). COPD exacerbations, defined as an acute worsening of COPD symptoms, were classified as being in one of 3 levels: Level I (can by self-managed by the participant); Level II (requires a physician visit), or Level III (requires a hospital visit).|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan.|||percentage of participants|||Number
1447198|NCT00874497|Secondary|Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications|Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 14 and 9 respectively.|||number of puffs||Standard Deviation|Mean
1447199|NCT00874497|Secondary|Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum|Participants used the Breathlessness, Cough, and Sputum Scale (BCSS) as the diary to daily monitor and rate their symptoms of difficulty breathing, cough, and sputum. The scale allows patients to rate each symptom on a scale of 0 (no difficultly for breathing and sputum, or unaware of coughing) to 4 (an almost constant problem for breathing and sputum, or almost constant for cough).|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 13 and 9 respectively.|||units on a scale||Standard Deviation|Mean
1447200|NCT00874497|Secondary|Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)|Change from baseline in sRaw and sGaw is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.|||kPa.sec||Standard Deviation|Mean
1447201|NCT00874497|Secondary|Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)|Change from Baseline in DLco is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.|||mmoL/min/kPA||Standard Deviation|Mean
1447202|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)|Change from baseline in trough FRCpleth is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 15 respectively.|||mL||Standard Deviation|Mean
1447203|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough Inspiratory Capacity|Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table.|Baseline toWeek 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 25 and 14 respectively.|||mL||Standard Deviation|Mean
1447204|NCT00874497|Secondary|Change From Baseline to Week 104 in Trough RV/TLC|Change from Baseline in Trough RV/TLC is presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were n= 21 and 14 respectively.|||unitless||Standard Deviation|Mean
1447205|NCT00874497|Secondary|Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])|Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 22 and 16 respectively.|||mL||Standard Deviation|Mean
1447206|NCT00874497|Secondary|Change From Baseline to Week 104 in Cumulative Frequency of HU|The area under the curve (AUC) is defined as the cumulative voxel frequency in HU (ie, the value of the density mask denominator). Blood samples (4 mL) for pharmacokinetic analysis were collected for the determination of plasma OPC-6535 concentrations at Predose on Day 1 and Weeks 26, 52, 78 and 104.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.|||Hounsfield unit*hour||Standard Deviation|Mean
1447207|NCT00874497|Secondary|Observed Rate of Change in Emphysema From Baseline to Week 104|The level of emphysema (g/L) within in a lung region is defined as the value of the selected percentile (10th, 15th, or 20th) in HU + 1000. The rate of change in the emphysema from baseline was calculated as the change in the level of emphysema from baseline to the specified visit divided by the time in years between the baseline and specified visit (i.e., [date of visit – date of baseline visit + 1]/365.25).|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.|||g/L||Standard Deviation|Mean
1447208|NCT00874497|Secondary|Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104|The rate of change in lung density was calculated as the change in the 20th percentile of lung density voxels divided by the duration between the dates of measurement (month or year) where applicable. For example, if HRCT measurements are available over a span of 2 years, the annual rate of change was calculated as the difference over the 2 years divided by 2, where years between scans is given by years= floor(data of last scan - date of first scan + 1)/365.25.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 46 and 26 respectively.|||Hounsfield unit/year||Standard Deviation|Mean
1447209|NCT00874497|Secondary|Density Mask Score Based on Specified Thresholds Including -950 HU|The density mask score is defined as the percentage of lung density voxels that lie below a specified threshold in the lung region of interest. The higher the percentage of the participant's lung density voxels that lie below a specified threshold, the higher the level of the participant's emphysema in the lung region under consideration. Changes in the density mask score was assessed using only a single density mask threshold of -950 HU.|Baseline and Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively.|||Hounsfield unit||Standard Deviation|Mean
1447210|NCT00874497|Secondary|Percent Change From Baseline in Trough FEV1 From Baseline to Week 104|The percent change for the pulmonary function tests (PFT) from baseline was calculated for each study week as follows: % change from baseline = ([value at Week X – value at baseline] /value at baseline) x 100.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 28 and 18 respectively.|||percentage change||Standard Deviation|Mean
1447211|NCT00874497|Primary|Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels|The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit [HU] using quantitative HCRT) by visit and lung region is presented below.|Baseline to Week 104|The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 43 and 25 respectively.|||Hounsfield unit/year||Standard Deviation|Mean
1447212|NCT00874497|Primary|Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)|The analysis of the change from Baseline to Week 104 (last observation carried forward [LOCF]) in trough FEV1 is presented below.|Baseline to Week 104|The Intent-to-Treat (ITT) population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable High-resolution computed tomography (HRCT) scan.|||L||Standard Deviation|Mean
1447213|NCT00874276|Secondary|Terminal Half-life (the Amount of Time Needed to Clear One-half of the Dose of Drug)for Environmental Dose 2.5 ug/kg/Day.|Terminal half-life (the amount of time needed to clear one-half of the dose of drug)for the environmental dose 2.5 ug/kg/day.|24 hours for analysis on Day 5, Environmental dose|same as Primary|||minutes||Inter-Quartile Range|Median
1447214|NCT00874276|Primary|Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized.|Terminal half-life (the amount of time needed to clear one-half of dose of the drug).|24 hours for analysis on Day 5, Clinical dose|All completing subjects (2 withdrawals have no pharmacokinetic data on this parameter) The intent was to accrue 12 per group but the grant ended before that could be achieved. Subjects were recruited from a large pool but the two genetically defined subgroups are rare.|||Minutes||Inter-Quartile Range|Median
1447224|NCT00874120|Primary|Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).|Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.|24 hours after final dose of each 7-day treatment period.|The per-protocol population included 100 participants who completed both treatment periods and have 24-hour Ambulatory Blood Pressure Monitoring (ABPM) data for SBP measurements for each study drug, 46 participants who received phenylephrine followed by placebo and 54 participants who received placebo followed by phenylephrine.|||mmHg||Standard Deviation|Mean
1447225|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks|Pre-treatment to 6 weeks after treatment||||units on a scale||Standard Deviation|Mean
1447226|NCT00874094|Secondary|Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks|Pre-treatment to 2 weeks after treatment||||units on a scale||Standard Deviation|Mean
1447227|NCT00874094|Secondary|Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week|Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week|pre-treatment to 1 week after treatment|The number of participants required to demonstrate a 1 point difference between pre and post treatment values|||units on a scale||Standard Deviation|Mean
1447228|NCT00874094|Primary|Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.|Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.|Difference in Measurements taken Pre-treatment and 12 weeks after treatment.|Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant.|||units on a scale||Standard Deviation|Mean
1447229|NCT00874029|Secondary|Overall Subject Treatment Outcome and Satisfaction Using the Overall Treatment Evaluation (OTE)|The Overall Treatment Evaluation Survey refers to whether the patient felt symptoms improved, worsened or remained the same post treatment.|12 months||||percentage of patients|||Number
1447230|NCT00874029|Secondary|Change in Score on Questionnaire - General Health Outcome at 12 Months Post-procedure as Compared to Pre-procedure Using the EQ-5D (a Standardized Instrument for Use as a Measure of Health Outcome)|The EQ-5D is a standardized instrument with scores ranging from 0 to 100, for use as a measure of general health outcome, such as mobility, self-care, usual activities, pain/discomfort and anxiety and depression. An increase in the score post treatment indicates less disease burden.|12 months||||Units on a scale||Standard Deviation|Mean
1447231|NCT00874029|Secondary|Change in Fibroid Symptom Severity and Quality of Life Scores at 12 Months Post-procedure as Compared to Pre-procedure (Baseline) Using the Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) Assessment Tool.|"The Uterine Fibroid Symptom and Health Related Quality of Life (UFS-QoL) assessment tool measures symptom severity and Health related quality of life.~Symptom Severity (SS) - high scores indicate greater symptoms (bad) and low scores indicate less symptoms (good). Scores range from 0 to 100. Since this outcome measure indicates change in symptoms, a negative number indicates a reduction in symptoms and therefore improvement.~Health Related (HRQL) - high scores indicate better health state. Scores range from 0 to 100. Since this outcome measure indicates change in health and quality of life, a positive number indicates and improvement."|12 months from Baseline||||Units on a scale||Standard Deviation|Mean
1447232|NCT00874029|Secondary|Change in Uterine and Fibroid Volume at 12 Months Post-procedure Compared to Pre-procedure (Baseline) as Measured With Contrast-enhanced MRI (Magnetic Resonance Imaging)|Evaluate change from baseline in uterine volume and fibroid volume at 12 months post-procedure as measured by contrast-enhanced magnetic resonance imaging (MRI) measurements. Specifically, the outcomes of uterine and fibroid volume changes are expressed as a mean percentage of volume reduction. Treatment with RFA resulted in a reduction from baseline in total uterine and fibroid volume, as assessed by pretreatment and posttreatment MRI, at 3 and 12 months posttreatment.|12 month from Baseline|The Full Analysis Set (FAS) was used in the analysis of the change in total uterine and fibroid volumes between baseline and 12 months post treatment. Of the 137 Subjects enrolled, two were excluded from the FAS because they did not meet all of the inclusion/exclusion criteria.|||percentage of volume||95% Confidence Interval|Mean
1447233|NCT00874029|Primary|Surgical Re-Intervention for Menorrhagia at 12 Months Post-treatment|Patients who had surgical reintervention for bleeding prior to 12 months follow-up. Surgical reintervention success was defined as no surgical reintervention for menorrhagia within the 12-month posttreatment period.|12 months from Baseline||||participants|||Number
1447234|NCT00874029|Primary|Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure|An adverse event was defined as any untoward medical occurrence in a subject who uses a medical device, regardless of the presumed relationship of the event to the study device. A serious adverse event is defined as an untoward medical occurrence that results in death, is life threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. Preexisting conditions (i.e., underlying diseases that were present before the adverse event reporting period began), re-intervention for failure to meet the study endpoints, and pregnancy were not reported as adverse events. All adverse events that occured during the study were recorded on the Adverse Event case report form (CRF). The investigator recorded the adverse event and assessed the relationship of the adverse event to the device and/or procedure; the coding of the events was reviewed by the Clinical Events Committee (CEC).|12 months||||participants|||Number
1447235|NCT00874029|Primary|Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure|Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.|12 months from Baseline||||Percentage of participants|||Number
1447236|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-181 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
1447237|NCT00873912|Secondary|Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)|SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were an important medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.|Days 1-29 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
1447238|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One AE||Days 1-15 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
1447239|NCT00873912|Secondary|Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)|Solicited symptoms were collected from administration of investigational product through Study Day 15. For this study, solicited symptoms included: fever (> 100°F oral), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), headache.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
1447240|NCT00873912|Primary|Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F|The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.|Days 1-8 after vaccination|The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.|||participants|||Number
1447241|NCT00873873|Secondary|Protease/Antiprotease|"MMP9/TIMP 1 molar ratio MMP9 is matrix metalloproteinse 9 and is a protease enzyme that is responsible for tissue degradation of extracellular matrix and could be a factor in airway remodeling.~TIMP 1 is an abbreviation for tissue inhibitor of metalloproteinase-1 and is an inhibitor of MMP9 and would serve to balance the activity protease activity of MMP9 and this it is an anti-protease.~Therefore the ratio of MMP9 and TIMP1 is used to assess the relative balance of protease and antiprotease activity."|Measured at Year 2|54 participants had induced sputum data but 1 was excluded due to congenital anatomical anomaly (bronchial atresia).|||ratio||Standard Deviation|Mean
1447242|NCT00873873|Primary|Airway Wall Thickness|Segmental average airway wall thickness|Measured at Year 2|There were 43 participants with Chest CT data; 1 was excluded from the analysis due to incidental finding of an anatomical congenital anomaly.|||mm||Standard Deviation|Mean
1447243|NCT00873860|Secondary|Time to First Moderate or Severe Asthma Exacerbation|Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider.|Day 1 to Day 92 and Day 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.|||days||Standard Error|Mean
1447244|NCT00873860|Secondary|Moderate or Severe Asthma Exacerbations Per Person Per Annum|Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days*365 days, where X = 92 or 169).|Day 1 to Day 92 and Day 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.|||asthma exacerbations/person/annum||Standard Error|Mean
1447254|NCT00873860|Secondary|Number of Puffs of Rescue Beta-2 Agonist Per Week|Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169.|Day -7 to 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||puffs per week||Standard Deviation|Mean
1448688|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 1|Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg|baseline, week 1|FAS (LOCF)|||participants|||Number
1447245|NCT00873860|Secondary|Percentage of Participants With at Least 1 Moderate or Severe Exacerbation|Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of >= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission.|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation.|||Percentage of Participants|||Number
1447246|NCT00873860|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 to 169|Safety population included all participants who received any dose of the investigational product.|||participants|||Number
1447247|NCT00873860|Secondary|Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit||Day 1, 92 and 169|Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1447248|NCT00873860|Secondary|Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit||Day 1, 92 and 169|Safety population included all participants who received any dose of the investigational product. Here, ‘N’(number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1447249|NCT00873860|Secondary|Serum Concentration for CAT-354||Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169|Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
1447250|NCT00873860|Secondary|Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5|Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (<=) 0.75 or mean ACQ score greater than (>) 0.75 and less than (<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (>) 0.75 but less than (<) 1.5 indicated partly controlled asthma.|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.|||percentage of participants|||Number
1447251|NCT00873860|Secondary|Patient Global Impression of Change (PGIC)|Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better).|Day 92 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
1447252|NCT00873860|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline|Day 1, 29, 57, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
1447253|NCT00873860|Secondary|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores|Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).|Day 1, 29, 57, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||units on a scale||Standard Deviation|Mean
1447255|NCT00873860|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169|The PEF is a participant’s maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169.|Day -7 to 1 (predose), Day 2 to 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters/minute||Standard Deviation|Mean
1447256|NCT00873860|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169|Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline.|Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.|||liters||Standard Deviation|Mean
1447257|NCT00873860|Secondary|Time to First Observed Asthma Control|Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled).|Day 1 to Day 92 and Day 169|Evaluable population = all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Since, >50% participants for each arm achieved improvement through Day 92; the median time-to-first observed achievement is identical for data through Day 92 and Day 169.|||days||95% Confidence Interval|Median
1447258|NCT00873860|Primary|Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.|Day 1 and 92|Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, ‘n’ signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1447259|NCT00873821|Primary|Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration|Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24|Baseline (predose Day 1) to Day 13||||mg/dL||Standard Deviation|Least Squares Mean
1447260|NCT00873821|Primary|Number of Participants With Any Laboratory Adverse Experience|Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.|2 months|All study participants|||participants|||Number
1447261|NCT00873821|Primary|Number of Participants With Any Clinical Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.|2 months|All study participants|||participants|||Number
1447262|NCT00873782|Primary|Muscle, Nerve, or Vascular Damage|"Number of Participants with all of the following three:~Unchanged Doppler ultrasound to assess venous and arterial damage pre-and post perfusion based on report~Without clinically significant changes in electrodiagnostic testing using standard neurographic techniques pre-and post perfusion:>1 mSec change in baseline distal motor latency; <75% baseline compound muscle action potential amplitude, <75% baseline conduction velocity, sensory nerve action potential~Without clinically significant changes in Quantitative muscle testing (QMT) strength assessments pre-and post perfusion:< 85% baseline"|Measured within 2 weeks after limb perfusion procedure||||participants|||Number
1447263|NCT00873730|Secondary|Change in C-reactive Protein (CRP) From Baseline to Week 12.|CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.|Baseline and 12 weeks|The analysis population is the intent to treat.|||mg/l||Standard Deviation|Mean
1447264|NCT00873730|Secondary|Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms||12 weeks|The population for this assessment was patients who had ocular inflammatory disease at baseline. The number of patients analyzed is zero because no patients had symptoms of ocular inflammatory disease at baseline.|||patients|||Number
1447279|NCT00873457|Secondary|Event-free Survival|Event-free survival will be defined as the length of time between the discontinuation of study treatment and disease progression, next therapy, or death,whichever comes first, up to a maximum of 2 years.|up to a maximum of 2 years|All treated patients|||Days||Full Range|Median
1447265|NCT00873730|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12.|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and 12 weeks|The analysis population was the intent to treat population. Two scored areas had a different “Number of Participants Analyzed” in the etanercept arm. Bodily pain had 45 and Emotional role limitations had 46.|||units on scale||Standard Deviation|Mean
1447266|NCT00873730|Secondary|Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire|EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
1447267|NCT00873730|Secondary|Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12.|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||mm/hour||Standard Deviation|Mean
1447268|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12.|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober’s test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
1447269|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12.|BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0–10 (0=none and 10=very severe) patient’s answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
1447270|NCT00873730|Secondary|Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12.|BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0–10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
1447271|NCT00873730|Secondary|Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12.|Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 – 10 (0 = none and 10 = severe).|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
1447272|NCT00873730|Secondary|Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12.|Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 – 10 (0 = no pain and 10 = most severe pain).|Baseline and 12 weeks|The analysis population was the intent to treat population.|||units on scale||Standard Deviation|Mean
1447273|NCT00873730|Secondary|Number of Patients Achieving Partial Remission.|Partial remission defined as a score of less than 20 units (on a scale of 0–100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
1447274|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6.|ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
1447275|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
1447276|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
1447277|NCT00873730|Secondary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
1447278|NCT00873730|Primary|Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20.|ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.|12 weeks|The analysis population was the intent to treat population.|||patients|||Number
1447281|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 6 months of treatment|Patients who completed 6 months of therapy|||participants|||Number
1447282|NCT00873457|Primary|Overall Response|Per International Workshop on Chronic Lymphocytic Leukemia, Complete Response (CR):normal CBC; absence of the following: clonal lymphocytes in blood and marrow, lymphadenopathy, hepatomegaly or splenomegaly, and constitutional symptoms; and bone marrow has <30% lymphocytes, is normocellular, and is without B-lymphoid nodules. Partial Response(PR): one of the following: decrease lymphadenopathy ≥ 50%; decrease of liver and/or spleen size ≥ 50%, any constitutional symptoms, Polymorphonuclear leukocytes ≥ 1,500/µl or a 50% improvement, or decrease of circulating clonal B lymphocytes ≥ 50% AND one of the following: Platelets ≥ 100,000/µl or a 50% improvement, Hemoglobin ≥ 11.0 g/dl or a 50% improvement, Bone marrow has ≥ 30% lymphocytes, or B-lymphoid nodules, or not done. Overall Response (OR)= CR+PR|after 3 months of treatment|Patients who completed 3 months of therapy.|||participants|||Number
1447283|NCT00873366|Secondary|Median of 6 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447284|NCT00873366|Secondary|Median of 3 Month Endoxifen Steady State Concentrations (Endx Css) According to CYP2D6 Phenotype Group and Activity Score|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month Endx Css for each CYP2D6 phenotype group and the corresponding activity score are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447285|NCT00873366|Secondary|Median of 6 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447286|NCT00873366|Secondary|Median of 3 Month 4-hydroxy-tamoxifen (4HT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month 4HT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447287|NCT00873366|Secondary|Median of 6 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with Endoxifen pharmacokinetics data. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447368|NCT00872599|Secondary|HDL-cholesterol Measured During High Salt Fenofibrate in Salt-resistant and Salt-sensitive Hypertension|HDL-cholesterol concentration measured on the last day of fenofibrate treatment in salt-resistant and salt-sensitive hypertensive patients|Measured on day 6 of high salt intake and fenofibrate treatment|All subjects who completed the protocol|||mg/dL||Standard Deviation|Mean
1447288|NCT00873366|Secondary|Median of 3 Month N-desmethyl-tamoxifen (NDMT) Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month NDMT steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447289|NCT00873366|Secondary|Median of 6 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 6 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|6 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447290|NCT00873366|Secondary|Median of 3 Month Tamoxifen Steady State Plasma Concentrations According to CYP2D6 Phenotype Group|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The median of 3 month Tamoxifen steady state plasma concentrations for each CYP2D6 phenotype group are summarized below. Refer to Outcome Measure 1 Data Table for details on the combination of genotype for each participant that are defined for each CYP2D6 phenotype group."|3 Month|All eligible participants with pharmacokinetic data available. Data was not collected for the one participant with CYP2D6 phenotype group as IM/UM.|||nM||Full Range|Median
1447291|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between 6 Month DM-BT and 6 Month Endoxifen Steady State Concentrations|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)|6 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
1447292|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between 3 Month DM-BT and 3 Month Endoxifen Steady State Concentrations|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)|3 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
1447293|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio|Baseline, 3 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
1447294|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between Baseline DM-BT and 3 Month Endoxifen Steady State Concentrations|Spearman rank order correlation coefficients were used to assess the strength of the association between baseline ¹³Cdextromethorphan breath test (DM-BT) and Endoxifen steady state concentrations (Endx Css)|Baseline, 3 month|All eligible participants with DM-BT values and Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
1447295|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen/N-desmethyl-tamoxifen (Endx/NDMT) Ratio|Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx/NDMT ratio|3 Month and 6 Month|All eligible participants with Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
1447296|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between CYP2D6 Activity Score and Endoxifen Steady State Concentrations (Endx Css)|Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and Endx Css|3 Month and 6 Month|All eligible participants with Endoxifen pharmacokinetics data.|||Correlation coefficient|||Number
1447297|NCT00873366|Secondary|Spearman's Rank Correlation Coefficient Between CYP2D6 Genotype and ¹³Cdextromethorphan Breath Test (DM-BT)|Spearman rank order correlation coefficients were used to assess the strength of the association between CYP2D6 genotype activity score and DM-BT values.|Baseline, 3 month and 6 month|All eligible participants with DM-BT values.|||Correlation coefficient|||Number
1447298|NCT00873366|Primary|Operating Characteristics of the ¹³C-dextromethorphan (13C-DM) Breath Test in Identifying Those Who Are CYP2D6 Genotypic Poor Metabolizers|"Participants were classified as having CYP2D6 decreased or non-decreased metabolism based on genotype and the co-prescription of inhibitors of the enzyme system.~The specific phenotype, alleles and their associated activity score (AS) assessed were as follows:~Ultrarapid metabolism (UM) or AS=2.0 (*1XN or *2XN), Extensive metabolism (EM) or AS=1.0 (*1, *2, and *2A), Intermediate metabolism (IM) or AS=0.5 (*9, *10, *17 and *41), and Poor metabolism (PM) or AS=0.0 (3, *4, *5, *7, *8, *11, and *12). The distribution of CYP2D6 genotypes grouped by CYP2D6 metabolism phenotype for each participants are summarized below."|Baseline||||Participants|||Count of Participants
1447299|NCT00873327|Primary|Piperacillin Pharmacokinetics (PK)|To study how Piperacillin is metabolized in the body by measuring the drug concentration in plasma samples collected at different time points during the study|2-3 days after infant receives 1st drug dosing|All 32 subjects that were enrolled during the study.|||L/hr/kg||95% Confidence Interval|Median
1447300|NCT00873119|Secondary|Time to Progression (TTP)|Time from the date of randomization to the time of disease progression|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported.|||months||95% Confidence Interval|Median
1447301|NCT00873119|Secondary|Duration of Response|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD ([Progressive Disease]) or death was documented|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication|||months||95% Confidence Interval|Median
1447302|NCT00873119|Secondary|Time to Response|For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Patients with overall best response being either complete response or partial response.|||months||Full Range|Median
1447303|NCT00873119|Secondary|Overall Survival (OS)|Time from the date of randomization to the date of death|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored.|||months||95% Confidence Interval|Median
1447304|NCT00873119|Secondary|Best Overall Response|The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR)|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population.|||percentage of participants|||Number
1447305|NCT00873119|Primary|Progression Free Survival|Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).|Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study|Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy|||months||95% Confidence Interval|Median
1447306|NCT00873093|Other Pre-specified|Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.|This outcome measure cannot be reported due to the data used for analysis was not collected.|Day 8 of blocks 1 and 2|||||||
1447307|NCT00873093|Other Pre-specified|Plasma Concentration-time Profiles|Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).|Up to day 8 of block 2|These were for correlative biology studies and the data were not collected in COG database.||||||
1447308|NCT00873093|Other Pre-specified|Change in Stem Cell Percentage|Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.|Baseline to post-treatment with bortezomib|These were for correlative biology studies and the data were not collected in COG database.||||||
1447309|NCT00873093|Other Pre-specified|Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots|Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.||||||
1447310|NCT00873093|Other Pre-specified|NF-kB Activity|NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.|Up to 5 years|These were for correlative biology studies and the data were not collected in COG database.||||||
1447311|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3.|End of Block 3 (Day 36 of Block 3) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3.|||Percentage of participants|||Number
1447312|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2.|End of Block 2 (Day 36 of Block 2) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.|||percentage of participants|||Number
1447313|NCT00873093|Secondary|Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1|Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1.|End of Block 1 (Day 36 of Block 1) of re-induction therapy|The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.|||percentage of participants|||Number
1447314|NCT00873093|Primary|Severe Adverse Events (SAE) Rate.|The proportion of SAE rate among all eligible patients|4 months|The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.|||percentage of participants|||Number
1447315|NCT00873093|Primary|Toxic Death Rate|The proportion of toxic death rate among all eligible patients.|4 months|The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.|||percentage of participants|||Number
1447316|NCT00873093|Primary|Event Free Survival|Percentage of patients who were event free at 4 months|4 months after enrollment|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.|||Percentage of participants|||Number
1447317|NCT00873093|Primary|Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy|The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.|The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.|The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.|||Percentage of participants|||Number
1447318|NCT00873041|Secondary|Extension Study: Change From Baseline in Transferrin Saturation at Month 24|Blood was collected for transferrin saturation at Baseline and Month 24. Change from baseline= Month 24 transferrin saturation - baseline transferrin saturation.|Core Baseline, Month 24|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.|||Percent saturation||95% Confidence Interval|Mean
1447319|NCT00873041|Secondary|Extension Study: Change From Baseline in Hemoglobin at Month 24|Blood was collected for Hemoglobin at Baseline and Month 24. Change from Baseline= Month 24 hemoglobin - Baseline hemoglobin.|Core Baseline, Month 24|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.|||g/L||95% Confidence Interval|Mean
1447320|NCT00873041|Secondary|Extension Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for serum ferritin difference from Baseline at Month 24 versus LIC difference from Baseline at Month 24.~A value of 1.0 indicates a perfect correlation."|Core Baseline, Month 24|Participants from the Extension Full Analysis Set (all randomized participants)in the Extension Study with data available for analysis.|||Correlation coefficient|||Number
1447321|NCT00873041|Secondary|Extension Study: Change in Liver Iron Concentration (LIC) From Baseline at Month 24|LIC was measured by magnetic resonance imaging technique at Baseline and Month 24. A negative change from baseline indicated improvement.|Core Baseline, Month 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
1447322|NCT00873041|Primary|Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study|Liver iron concentration was measured at Core Baseline and at the end of the Extension Study. Magnetic Resonance Imaging (MRI) scans were analyzed at a central laboratory to determine the LIC value. The percentage of participants with LIC < 5 mgFe/g dw (milligram iron/gram dry weight) change from Baseline at the end of the Extension Study is reported.|Core Baseline to End of Extension Study (up to 24 months)|Full Analysis consisted of all randomized participants. Patients with post-baseline LIC satisfying criterion at any time during the study are counted as responder. Patients with no baseline LIC or without any post-baseline LIC measurements will be assumed as non-responder.|||Percentage of participants||95% Confidence Interval|Number
1447323|NCT00873041|Secondary|Extension Study: Absolute Change in Serum Ferritin From Baseline to Eighth Quarter|Blood was collected for serum ferritin at Core Baseline and monthly during the Eighth quarter of the Extension Study. Absolute change from Baseline: quarterly average – baseline average. A negative change from baseline indicated improvement.|Core Baseline, Eighth Quarter (last 3 months of the study)|Full Analysis Set included all randomized participants. Only patients with a value both at baseline and at considered time point are included.|||micrograms/liter||Standard Deviation|Mean
1447324|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Pulse Rate|"Pulse Rate was measured at each visit.~A Notably Abnormal Pulse Rate was defined as a measurement in one of the following two categories:~High: ≥120 with an increase from baseline ≥15 beats per minute (bpm)~Low: ≤50 with a decrease from baseline ≥15 bpm"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.|||Percentage of participants|||Number
1447325|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Diastolic Blood Pressure|"Diastolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.~A Notably Abnormal Diastolic Blood Pressure was defined as a measurement in one of the following two categories:~High: ≥105 with an increase from baseline ≥15 mmHg~Low: ≤50 with a decrease from baseline ≥15 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.|||Percentage of participants|||Number
1447326|NCT00873041|Secondary|Core Study: Percentage of Participants With Notably Abnormal Post-baseline Systolic Blood Pressure|"Systolic blood pressure was measured at each visit after the patient rested in the sitting position for at least 3 minutes.~A Notably Abnormal Systolic Blood Pressure was defined as a measurement in one of the following two categories:~High: ≥180 with an increase from baseline ≥20 mmHg~Low: ≤90 with a decrease from baseline ≥20 mmHg"|Baseline, 52 Weeks|Safety Set includes all randomized participants who received treatment.|||Percentage of participants|||Number
1448689|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 2|SBP < 140 mmHg and DBP < 90 mmHg|week 2|FAS (LOCF)|||participants|||Number
1447327|NCT00873041|Primary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 52 with treatment as factor and baseline LIC as covariate.|Baseline, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
1447328|NCT00873041|Secondary|Core Study: Percentage of Participants With Notable Abnormal Post-baseline Laboratory Results|"The percentage of participants with notable laboratory results:~Platelet count: (<100 x 10^9/L)~Absolute neutrophils: (<1.5 x 10^9/L)~Alanine aminotransferase (ALT): (>5 x Upper limit normal (ULN) and >2 x baseline).~Aspartate aminotransferase (AST): (>5 x ULN and >2 x baseline)~Serum creatinine: (>33% increase from baseline and >ULN at ≥2 consecutive post-baseline values) Creatinine clearance: (<60 mL/min at ≥2 consecutive post-baseline values)~Urinary protein/creatinine ratio: (≥ 1.0 mg/mg at ≥2 consecutive post-baseline values)"|52 Weeks|Safety Set included all randomized participants who received treatment.|||Percentage of participants|||Number
1447329|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) in Placebo Patients From Baseline to Week 52|LIC was measured by magnetic resonance imaging technique at baseline and Week 52. The change in liver iron concentration for participants in the placebo arm was used to assess the iron accumulation rate.|Baseline, Week 52|Safety Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 52. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
1447330|NCT00873041|Secondary|Core Study: Change From Baseline in Transferrin Saturation at Month 12|Blood was collected for transferrin saturation at Baseline and Month 12. Change from baseline= Month 12 transferrin saturation - baseline transferrin saturation.|Baseline, Month 12|Full Analysis Set (all randomized patients). Only patients with a value both at baseline and at considered timepoint are included in the analyses.|||Percent saturation||Standard Deviation|Mean
1447331|NCT00873041|Secondary|Core Study: Change From Baseline in Hemoglobin at Month 12|Blood was collected for Hemoglobin at baseline and Month 12. Change from baseline= Month 12 hemoglobin - baseline hemoglobin.|Baseline, Month 12|Full Analysis Set (all randomized participants). Only patients with a value both at baseline and at considered timepoint are included in analyses.|||g/L||Standard Deviation|Mean
1447332|NCT00873041|Secondary|Core Study: Correlation Between Serum Ferritin and LIC (Liver Iron Concentration)|"The correlation between serum ferritin and LIC was investigated using a scatter plot with a regression line for the following cases:~Baseline serum ferritin versus baseline LIC~Serum ferritin difference from baseline at fourth quarter versus difference from baseline in LIC at Week 52.~A value of 1.0 indicates a perfect correlation."|Baseline, 52 weeks|Participants from the Full Analysis Set (all randomized participants).|||Correlation coefficient|||Number
1447333|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline At Week 24 and Week 52 in Patients With Dose Increases After Week 24|LIC was measured by magnetic resonance imaging technique at baseline, Week 24 and Week 52. Dose Doubling (Dose Increases) began at Week 24.|Baseline, Week 24, Week 52|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24 and Week 52. Only patients with dose increases after week 24, with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Deviation|Mean
1447334|NCT00873041|Secondary|Core Study: Percentage of Participants With Adverse Events Graded Mild, Moderate and Severe|Percentage of Participants with Mild, Moderate and Severe adverse events (AE) any primary system organ class regardless of study drug relationship. A patient with multiple occurrences of an AE is counted only once in the AE category for that treatment. A patient with multiple severity ratings for an AE while on a treatment is only counted once under the maximum rating.|52 Weeks|Safety Analysis Set included all randomized participants who received treatment.|||Percentage of participants|||Number
1447335|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Second Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.~Second quarter serum ferritin average was the average of all serum ferritin values obtained within days 106-195.~Change from baseline: second quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 106 to Day 195)|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the second quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.|||μg/L||Standard Deviation|Mean
1447336|NCT00873041|Secondary|Core Study: Change in Serum Ferritin Between Baseline and Fourth Quarter|"Baseline serum ferritin average was the average of all available ferritin values from screening to last sample prior to the first intake of study drug.~Fourth quarter serum ferritin average was the average of all serum ferritin values obtained within days 286- End of Study.~Change from baseline: fourth quarter serum ferritin average - baseline serum ferritin average."|Baseline, (Day 286 to End of Study [Day 365])|Full Analysis set (all randomized patients). Only participants with both baseline and post-baseline values are included in analyses. If serum ferritin was missing during the fourth quarter, the last available average of serum ferritin per quarter was used for the calculation of the change from baseline.|||μg/L||Standard Deviation|Mean
1447337|NCT00873041|Secondary|Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 24|LIC was measured by magnetic resonance imaging technique at baseline and Week 24. Estimates were obtained from an Analysis of Covariance (ANCOVA) model for change in LIC between baseline and Week 24 with treatment as factor and baseline LIC as covariate.|Baseline, Week 24|Full Analysis Set. The last available post-baseline LIC was carried forward if no LIC value was available at Week 24. Only patients with both baseline and at least one post-baseline value were included for this analysis.|||mg iron (Fe)/g dry weight (dw)||Standard Error|Least Squares Mean
1447338|NCT00873015|Secondary|Efficacy of 14 Day Infusion of Sodium Nitrite||14 days|||||||
1447339|NCT00873015|Secondary|Safety of a 14 Day Infusion of Sodium Nitrite||14 days|||||||
1448690|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 1|Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg|week 1|FAS (LOCF)|||participants|||Number
1447340|NCT00873015|Primary|Mean Plasma Nitrite Concentration (Micromol/L)|Samples for pharmacokinetic analysis were collected from subjects treated with sodium nitrite at -15, -5, 0, 10, 30, 60, and 90 minutes after starting nitrite infusion and then at 2, 4, 6, 8, 12, 24, and every 24 hours after starting nitrite infusion. The sample at the time of starting the infusion was considered to be the time 0 sample. On study day 14 additional blood samples were collected at 0, 10, 30, 60, and 90 minutes and at 2, 4, 6, 8, and 12 hours after stopping nitrite infusion. Blood samples were analyzed for nitrite levels using mass spectroscopy.|multiple time points up to the end of day 14|Per protocol|||micromol/L||Standard Deviation|Mean
1447341|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.|||participants|||Number
1447342|NCT00872989|Secondary|Time to Treatment Failure|Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.||||Months||95% Confidence Interval|Median
1447343|NCT00872989|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1447344|NCT00872989|Secondary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|every 3 months for two years and then every 6 months for 3 years||||months||95% Confidence Interval|Median
1447345|NCT00872989|Secondary|Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in conjunction with measured CA125 responses|Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years.|Analysis of response is in the subset of patients who had at least one measurable target lesion at baseline.|||participants|||Number
1447346|NCT00872989|Primary|Progression Free Survival (PFS)|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years||||months||95% Confidence Interval|Median
1447347|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale|"The Children’s Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447348|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale|"The Children’s Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447349|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale|"The Children’s Communication Checklist-2 (CCC-2) Nonverbal Communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447384|NCT00872521|Secondary|Disease Response After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Particiipants|||Number
1447350|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale|"The Children’s Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447351|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale|"The Children’s Communication Checklist-2 (CCC-2) Scripted Language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447352|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale|"The Children’s Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447353|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale|"The Children’s Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447354|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale|"The Children’s Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447355|NCT00872898|Secondary|Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale|"The Children’s Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447356|NCT00872898|Secondary|Change in Children’s Communication Checklist-2 (CCC-2) - Speech Subscale|"The Children’s Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).~The Children’s Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70)."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447383|NCT00872521|Secondary|Overall Response Rate (ORR) to Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction 3-months Following Autologous Stem Cell Transplant (ASCT).|Responders are the number of participants who achieved stringent complete response (sCR)/ complete response (CR), very good partial response (VGPR) or partial response (PR) following PAD induction.|3-months following ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Participants|||Number
1447357|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Communication|"The Core Autism Treatment Scale-Improvement (CATS-I) Communication Subscale is based on rating 5 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 5 (improved) to 35 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447358|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Social Interaction|"The Core Autism Treatment Scale-Improvement (CATS-I) Social Interaction Subscale is based on rating 9 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 9 (improved) to 63 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447359|NCT00872898|Primary|Change in Total Raw Score of Social Responsiveness Scale|"The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment).~Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment."|From Baseline to Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447360|NCT00872898|Secondary|Core Autism Treatment Scale-Improvement: Total Score|"The Core Autism Treatment Scale-Improvement (CATS-I) is based on rating 14 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 14 (improved) to 98 (worsened).~The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe)."|At Week 12|All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.|||units on a scale||Standard Error|Least Squares Mean
1447361|NCT00872898|Primary|Extent of Absorption of Memantine (Part One)|Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.|Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose|Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population)|||ng•h/mL||Standard Deviation|Mean
1447362|NCT00872833|Secondary|Report of Pain by Length of the Transfusion Cycle|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles|Unit of analysis was participant-cycle. Data were collected over (at most) three transfusion cycles for each subject. Transfusion cycle lengths varied, and subjects may be represented in more than one arm/group.|||percentage of participant-cycles|Participants||Number
1447363|NCT00872833|Primary|Report of Pain by Age Group|Subjects reported whether or not they had pain (yes/no) during each transfusion cycle (data on up to 3 transfusion cycles were collected for each subject). The percent of subject-cycles with pain was calculated for the quartiles of the transfusion cycle.|measured daily over the 3 transfusion cycles||||percentage of participant-cycles|Participants||Number
1447364|NCT00872729|Primary|Pharmacodynamic Parameter: Changes of White Blood Cell (WBC) Cystine Level From Baseline|"The pharmacodynamic (PD) parameter measures the changes of WBC cystine level from the baseline.~Cystine is a disulfide amino acid formed through oxidation of two molecules of cysteine; hence, cystine’s concentration is commonly given in half-cystine equivalents to avoid confusion.~The level of cystine in WBC/leukocytes is expressed in units of nmol half-cystine/mg protein (nmol ½ cystine/mg protein). Half-cystine is quantified by a reduction of cystine followed by an assay for cysteine, which is then normalized by the total cellular protein content within the sample using methods of such as Lowry assay, bicinchoninic acid assay, or Bradford."|up to 12 hours post Cystagon® dosing and RP103 dosing|Sample size is based on feasibility rather than statistical considerations. Analysis time differences (0-6 hours) is due to different absorption characteristics of Cysteamine between RP103 and Cystagon. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.|||nmol 1/2 cystine/mg protein||Standard Deviation|Mean
1447365|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: AUC(0-t) of Cysteamine|t = 6 for Cystagon and t = 12 for RP103. Cystagon is dosed every 6 hours and there is no measurement after 6 hours and up to 12 hours.|12 hours post RP103 dosing and 6 hours post 1st Cystagon® dosing|Subjects were enrolled sequentially according to the study design. A mixed-effects linear model was used to assess differences between the RP103 and Cystagon treatment groups. Sample size is based on feasibility rather than statistical considerations.|||umol•h/L||Geometric Coefficient of Variation|Geometric Mean
1447366|NCT00872729|Primary|Plasma Pharmacokinetic Parameter: Tmax of Cysteamine||12 hours post RP103 dosing and 7 hours post 1st Cystagon® dosing||||hour||Full Range|Median
1447369|NCT00872599|Primary|Change in Blood Pressure During High Salt Intake and Fenofibrate Treatment Compared to High Salt Intake and Placebo Treatment|"Difference in blood pressure (mean arterial pressure) measured on the last day of high salt intake and fenofibrate treatment minus blood pressure (mean arterial pressure) measured during high salt intake and placebo treatment in participants classified as being salt-sensitive versus salt-resistant.~Participants were classified as salt-sensitive if the average study day mean arterial pressure (MAP) was at least 5 mmHg higher during the high salt placebo arm than during low salt intake."|pressure measured on day 6 of high salt fenofibrate minus pressure measured on day 6 of high salt placebo|All subjects who completed entire protocol|||mm Hg||Standard Deviation|Mean
1447370|NCT00872534|Primary|Incidence of Subjects With Gastroduodenal Erosions and Ulcers.|Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).|After 7 days of study medication||||participants|||Number
1447371|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (FGFR3)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (FGFR3).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
1447372|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Bcl-2)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (bcl-2).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
1447373|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (Cyclin D1)|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (Cyclin D1).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
1447374|NCT00872521|Secondary|Overall Survival (OS) Stratified by Protein Expression (p53).|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD) stratified by protein expression (p53).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The OS was not imputed.|||Percentage of participants|||Number
1447375|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (FGFR3)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (FGFR3)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
1447376|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Bcl-2)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (bcl-2)|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
1447377|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (Cyclin D1).|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (Cyclin D1).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
1447378|NCT00872521|Secondary|Overall Response Rate (ORR) Stratified by Protein Expression (p53)|Number of participants who are responders and nonresponders after 4 cycles of bortezomib, doxorubicin and dexamethasone (PAD) induction stratified by protein expression (p53).|84 days|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD. The ORR was imputed, with those who discontinued treatment or who had efficacy data unavailable being coded as Non-Responders.|||Participants|||Number
1447379|NCT00872521|Secondary|Assessment of Quality of Life (AQoL) Scores|The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).|Up to 2 years|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Scores on a scale||Standard Deviation|Mean
1447380|NCT00872521|Secondary|Overall Survival|Percentage of participants who had no event of death 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Percentage of participants|||Number
1447381|NCT00872521|Secondary|Event Free Survival (EFS)|Percentage of participants who did not have any of the following events: Death, Disease progression, Relapse, Cardiovascular accidents, Deep vein thrombosis, Pulmonary embolism, Fracture, Acute renal failure, Nervous system disorders 2 years after Day 1 Cycle 1 of bortezomib, doxorubicin and dexamethasone (PAD).|2 years after Day 1 Cycle 1 of PAD|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Percentage of participants|||Number
1447382|NCT00872521|Secondary|Disease Response 3-months After Autologous Stem Cell Transplant (ASCT)|Number of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), stable disease (SD) and relapse as per IMWG criteria.|3-months after ASCT|Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD|||Participants|||Number
1447844|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447385|NCT00872521|Primary|Overall Response Rate (ORR): Number of Participants Who Are Responders (Had Stringent Complete Response [sCR], CR, Very Good Partial Response [VGPR] or Partial Response [PR]) After 4 Cycles of Bortezomib, Doxorubicin and Dexamethasone (PAD) Induction|International Myeloma Working Group (IMWG) criteria – CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour|84 days|Intent-to-treat (ITT) population- All enrolled participants who proceeded to receive Day 1 of Cycle 1 of PAD induction.|||Participants|||Number
1447386|NCT00872430|Primary|Intestinal Transit Time|Radiologic technique consisting of the ingestion of radiopaque markers, followed by a simple x-ray of the abdomen on day 3 of each intervention period. Standard formula, regarding markers ingested, time of ingestion and markers still present on the colon (counted by radiologist unaware of the treatment allocation), provided transit time.|day 3 and day 17||||hours||Standard Deviation|Mean
1447387|NCT00872430|Secondary|Number of Patients With no Evacuation After Each Intervention Period|The number of patients who had not evacuated on day 5 of each intervention period was obtained using questions 1 and 9 of the Scale for Assessment of Constipation Symptoms based on: 1) How many times have you had a bowel movement in the last 24 hours?; 9) Classification of bowel habit on a scale of 1 (terrible) to 5 (excellent).|day 5 and day 19||||participants|||Number
1447388|NCT00872339|Secondary|Impact of Pain on Functioning and Well-being||Measured at Month 9||||participants|||Number
1447389|NCT00872339|Secondary|Pain Occurrence by Age||Measured at Month 9||||participants|||Number
1447390|NCT00872339|Secondary|Common Sites of Pain||Measured at Month 9||||participants|||Number
1447391|NCT00872339|Primary|Prevalence of Pain||Measured at Month 9||||participants|||Number
1447392|NCT00872170|Secondary|Change in Arginase Activity From Baseline to Week 12 Among Sildenafil Group|Change in Arginase activity was calculated as Arginase activity at week 12 minus Arginase activity at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||U/L||Standard Error|Mean
1447393|NCT00872170|Secondary|Change in Arginase Concentration From Baseline to Week 12 Among Sildenafil Group|Change in Arginase concentration was calculated as Arginase concentration at week 12 minus Arginase concentration at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ng/ml||Standard Error|Mean
1447394|NCT00872170|Secondary|Change in Cell Free Hemoglobin From Baseline to Week 12 Among Sildenafil Group|Change in Cell Free Hemoglobin was calculated as Cell Free Hemoglobin at week 12 minus Cell Free Hemoglobin at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ug/ml||Standard Error|Mean
1447395|NCT00872170|Secondary|Change in Lactate Dehydrogenase (LDH) From Baseline to Week 12 Among Sildenafil Group|Change in Lactate dehydrogenase (LDH) was calculated as LDH at week 12 minus LDH at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no LDH at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.|||U/L||Standard Error|Mean
1447396|NCT00872170|Secondary|Change in Soluble Platelet Selectin (sP-SELECTIN) From Baseline to Week 12 Among Sildenafil Group|Change in Soluble platelet selectin (sP-SELECTIN) was calculated as sP-SELECTIN at week 12 minus sP-SELECTIN at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ng/ml||Standard Error|Mean
1447397|NCT00872170|Secondary|Change in Red Blood Cell (RBC) Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Red Blood Cell (RBC) Arginine was calculated as Red Blood Cell (RBC) Arginine at week 12 minus Red Blood Cell (RBC) Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||µM||Standard Error|Mean
1447398|NCT00872170|Secondary|Change in Plasma Arginine From Baseline to Week 12 Among Sildenafil Group|Change in Plasma Arginine was calculated as Plasma Arginine at week 12 minus Plasma Arginine at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||µM||Standard Error|Mean
1447399|NCT00872170|Secondary|Change in Echo Left Ventricular End Diastolic Volume (LVEDV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end diastolic volume (LVEDV) was calculated as LVEDV at week 12 minus LVEDV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ml||Standard Error|Mean
1448691|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 2|DBP < 90 mmHg|week 2|FAS (LOCF)|||participants|||Number
1447400|NCT00872170|Secondary|Change in Echo Left Ventricular End Systolic Volume (LVESV) From Baseline to Week 12 Among Sildenafil Group|Change in echo left ventricular end systolic volume (LVESV) was calculated as LVESV at week 12 minus LVESV at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||ml||Standard Error|Mean
1447401|NCT00872170|Secondary|Change in Tricuspid Regurgitant Jet Velocity (TRV) From Baseline to Week 12 Among Sildenafil Group|Change in tricuspid regurgitant jet velocity (TRV) was calculated as TRV at week 12 minus TRV at baseline. The TRV provides an estimate of pulmonary artery pressure.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and one patient who withdrew from the study were excluded. Patients in control group were only assessed at baseline. Therefore, 9 Sildenafil and 0 control patients were used.|||m/s||Standard Error|Mean
1447402|NCT00872170|Primary|Change in Six-minute Walk Test (6MWT) Distance From Baseline to Week 12 Among Sildenafil Group|Change in six-minute walk test (6MWT) distance was calculated as 6MWT at week 12 minus 6MWT at baseline.|Baseline and Week 12|Of 14 patients in the Sildenafil arm, 4 patients with discrepant Tricuspid Regurgitant Jet Velocity (TRV) measurements between the local site, core lab and NHLBI readings and 2 patients who had no 6MWT at 12 weeks were excluded. Patients in control group were only assessed at baseline. Therefore, 8 Sildenafil and 0 control patients were used.|||meters||Standard Error|Mean
1447403|NCT00872079|Primary|Patient Genomics|During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.|Baseline||||participants|||Number
1447404|NCT00872027|Primary|Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation||Measured within 2 days of participant recruitment||||participants|||Number
1447405|NCT00872001|Secondary|Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population)|Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.|||Percentage of Participants|||Number
1447406|NCT00872001|Primary|Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population)|Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.|Up to Post-Operative Day 28|The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.|||Percentage of Participants|||Number
1447407|NCT00871975|Primary|Number of Participants With Urodynamic Detrusor Overactivity Events or Prostatic Obstruction as Detected by Tetra-NIRS Compared to Urodynamics|The Tetra-NIRS device provides a linear pattern similar to the pressures obtained during urodynamics. The NIRS output shows relative change in hemoglobin concentrations (oxygenated and deoxygenated) where the numerical value does not actually indicate the concentration, so there is no unit of measure. The numerical output is used to track change over time, or trendline analysis. A qualified interpreter studied tracings for significant changes (+/-2 Hb units) in the NIRS patterning during detrusor overactivity events. As well, under its' approved intended use, Tetra-NIRS trendline analysis was compared against urodynamics during voiding in males, such that a downward trend during voiding indicates urethral obstruction, and an upward trend indicates an unobstructed urethra.|1 Year|Male and female patients were included, where the urodynamics tracings were compared against the Tetra NIRS tracings.|||participants|||Number
1447408|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Normal Glucose Tolerant (NGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the measure of the quantity of glucose disposed per unit of plasma insulin concentration (PIC). Approximate PIC was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals, time = 90, 100, 110, and 120 minutes. NGT participants (FPG <100 mg/dL & 2 hour PG <140 mg/dL during a 75g OGTT at screening) were neither IGT nor IFG at screening. IGT - defined as a 2 hour PG >= 140 and <= 199 mg/dL during a 75g OGTT at screening. IFG - defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
1447409|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
1447868|NCT00868140|Primary|Fasting Serum Insulin (uIU/ml)|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT following 6 months treatment with either pioglitazone or placebo|6 months||||uIU.min/ml||Standard Error|Mean
1447410|NCT00871871|Primary|Part II: Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady-state|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes.|90 -120 minutes post-dose|Number of participants who took ISMN/placebo.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
1447411|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants Who Had Normal Glucose Tolerance (NGT)|Steady state was defined as 90-120 minutes post-dose. NGT participants (FPG <100 mg/dL & 2 hour plasma glucose (PG) <140 mg/dL during a 75g oral glucose tolerance test (OGTT) at screening) were neither Impaired Glucose Tolerant (IGT) nor Impaired Fasting Glucose (IFG). IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening. IFG was defined as FPG between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with NGT.|||ng/minute||Standard Deviation|Least Squares Mean
1447412|NCT00871871|Secondary|Part I: Change in the Ratio of Whole Body Glucose Disposal to Plasma Insulin at Steady State in Participants With Impaired Glucose Tolerant (IGT)|Steady state was defined as 90-120 minutes post-dose. The ratio was the quantity of glucose disposed by the body per kg body weight per minute at steady state divided by the approximate steady state plasma insulin concentration. The approximate steady state plasma insulin concentration was estimated by the time-weighted average of the insulin concentration measured at 10 minute intervals in which time = 90, 100, 110, and 120 minutes. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.|||(mg/kg/minute)/(µIU/mL)||Standard Deviation|Least Squares Mean
1447413|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Fasting Glucose (IFG)|Steady state was defined as 90-120 minutes post-dose. IFG was defined as fasting plasma glucose (FPG) between 100 and 125 mg/dL at screening.|90 -120 minutes post-dose|Number of participants with IFG.|||ng/minute||Standard Deviation|Least Squares Mean
1447414|NCT00871871|Primary|Part I: Change in Insulin Secretion at Steady-state Compared to Placebo in Participants With Impaired Glucose Tolerance (IGT)|Steady state was defined as 90-120 minutes post-dose. IGT was defined as a 2 hour plasma glucose >= 140 and <= 199 mg/dL during a 75g oral glucose tolerance test at screening.|90 -120 minutes post-dose|Number of participants with IGT.|||ng/minute||Standard Deviation|Least Squares Mean
1447415|NCT00871819|Primary|Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)||Immediately post-procedure||||Correlation coefficient|||Number
1447416|NCT00871780|Secondary|Improvement in Timed 25FT Walk Speed and T100T Speed at Week 24 and 48|To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations, participants were stratified by baseline EDSS scores, and walking tests at Weeks 24 and 48 were analyzed. A 15% or 20% improvement indicates that, when compared with baseline walking speed (meters per second), there is at least 15% or 20% improvement at the corresponding timepoint, e.g. (speed at Week 24 – speed at baseline)/speed at baseline*100% ≥ 15% or 20%. Confirmed (conf) improvement at Week 48 indicates that the participant has at least 15% (or 20%) improvement in walking speed at both Week 24 and Week 48.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n= number of participants with evaluable data at time point.|||participants|||Number
1447417|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447418|NCT00871780|Secondary|Correlation Between the EDSS and T100T (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447419|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447420|NCT00871780|Secondary|Correlation Between the EDSS and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447421|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447422|NCT00871780|Secondary|Correlation Between the T100T and T25FW (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447423|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Spearman Correlation Coefficient)|Spearman correlation coefficient is a non-parametric measure of the correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447424|NCT00871780|Secondary|Correlation Between the EDSS and MWD (Pearson Correlation Coefficient)|Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data evaluated at given time point.|||Correlation coefficient|||Number
1447425|NCT00871780|Primary|Change From Baseline in Expanded Disability Status Scale (EDSS)|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.|||units on a scale||Inter-Quartile Range|Median
1447426|NCT00871780|Primary|Change From Baseline in Maximum Walking Distance (MWD)||Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=those participants with observed data at given time point.|||meters||Inter-Quartile Range|Median
1447427|NCT00871780|Primary|Change From Baseline in the Timed 25-foot Walk Test (T25FW)|In the T25FW, the participant is instructed to walk as fast as possible for a distance of 25 feet.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.|||seconds||Inter-Quartile Range|Median
1447428|NCT00871780|Primary|Change From Baseline in the Timed 100-meter Walk Test (T100T)|In the T100T, the participant is instructed to walk as fast as possible for a distance of 100 meters.|Baseline, Week 24, Week 48|Efficacy Analysis Population (participants who had at least 1 infusion of natalizumab and completed at least 1 on-treatment evaluation); n=number of participants with data at given time point.|||seconds||Inter-Quartile Range|Median
1447429|NCT00871741|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 9)|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1447430|NCT00871741|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1447431|NCT00871741|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|"The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature.~Any = any general symptom irrespective of intensity grade and relationship to vaccination.~Grade 3 Irritability = crying that could not be comforted/prevented normal activity.~Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination.~Subjects from Control Group did not receive the second study vaccination dose due to study termination."|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1447432|NCT00871741|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms|"The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.~Subjects from Control Group did not receive the second study vaccination dose due to study termination."|During the 8-day (Days 0-7) post-vaccination period following each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1447433|NCT00871741|Primary|Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL|As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.|At Month 3|||||||
1447434|NCT00871728|Secondary|Percentage of Participants Showing Mycological Cure|Mycological cure was defined as a case in which the results of both potassium hydroxide (KOH) smear test and bacterial identification test (BIT) were found to be negative at each pre-defined time point.|Week 13, 25, 37 and 49|The FAS population, missing values imputed using last observation carried forward (LOCF) method. 'n' included those participants who were evaluable for this measure at specific time points.|||percentage of participants|||Number
1447435|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 49|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 49 compared to Baseline were reported.|Baseline and Week 49|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
1447436|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 37|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 37 compared to Baseline were reported.|Baseline and Week 37|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
1447437|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 25|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 25 compared to Baseline were reported.|Baseline and Week 25|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
1447438|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 13|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 13 compared to Baseline were reported.|Baseline and Week 13|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
1447439|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 9|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 9 compared to Baseline were reported.|Baseline and Week 9|The FAS population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
1447440|NCT00871728|Primary|Percentage of Participants Showing 10 Percent or Higher Response in Scoring Clinical Index for Onychomycosis (SCIO) Score at Week 5|The SCIO is based on clinical state and its items include major factors that can have an effect on the outcome of onychomycosis treatment. The factors include the clinical form, depth of an infected area and subungal hyperkeratosis. The SCIO score range from 1 to 30 and higher score indicates more severity. The score is classified into 7 steps and as there is treatment for each step, treatment based on the clinical state can be applied consistently. Percentage of participants who show an improvement in SCIO score by 10 percent or more at Week 5 compared to Baseline were reported.|Baseline and Week 5|The Full analysis set (FAS) population included all participants except for those participants who violated the major selection and exclusion criteria or did not take the study medication even once or those participants who didn’t participate in Week 5 assessment.|||percentage of participants|||Number
1447441|NCT00871715|Other Pre-specified|Exit Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Post-intervention to 1 year post-randomization||2017-08-31|08/2017||||
1447442|NCT00871715|Other Pre-specified|Post-Intervention Interview|A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|16-20 weeks post-randomization||2017-08-31|08/2017||||
1447443|NCT00871715|Other Pre-specified|Monthly Telephone Interviews|A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|monthly, beginning 30 days post-randomization||2017-08-31|08/2017||||
1447444|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)|Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447445|NCT00871715|Secondary|Color Trails Making Tests 1 & 2|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447446|NCT00871715|Secondary|Digits Span Backward|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447447|NCT00871715|Secondary|Hopkins Verbal Learning Test, Revised (HVLT-R)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447448|NCT00871715|Secondary|D-KEFS Verbal Fluency Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447449|NCT00871715|Secondary|Short Blessed Memory Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447450|NCT00871715|Secondary|Confidence in Arm & Hand Movement (CAHM)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447451|NCT00871715|Secondary|EQ5D|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447452|NCT00871715|Secondary|Single-Item Subjective Quality of Life Measurement (SQOL)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447453|NCT00871715|Secondary|Reintegration to Normal Living Index (RNLI)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447454|NCT00871715|Secondary|Satisfaction With Life Scale (SWLS)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447455|NCT00871715|Secondary|Motor Activity Log 28 QOM (MAL-28)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447456|NCT00871715|Secondary|As-Tex Sensory Index|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447457|NCT00871715|Secondary|Patient Health Questionnaire 9 (PHQ-9)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447458|NCT00871715|Secondary|Upper Extremity Fugl Meyer (UEFM), Motor Component|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447459|NCT00871715|Secondary|Wolf Motor Function Test (WMFT) Strength Components|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447460|NCT00871715|Secondary|Arm Muscle Torque Test|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447461|NCT00871715|Secondary|National Institute of Health Stroke Scale (NIHSS)|Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.|Baseline to 1 year post-randomization||2017-08-31|08/2017||||
1447462|NCT00871715|Primary|Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization)|The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||percentage of participants|||Number
1447463|NCT00871715|Primary|Stroke Impact Scale (SIS) Hand Function Subscale Score.|Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||units on a scale||95% Confidence Interval|Mean
1447464|NCT00871715|Primary|Wolf Motor Function Test Time|Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||seconds||95% Confidence Interval|Mean
1447465|NCT00871715|Primary|Wolf Motor Function Test (WMFT) Log-transformed Time|Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.|Baseline to 1 year post-randomization|Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.|||log(seconds)||95% Confidence Interval|Mean
1447466|NCT00871689|Secondary|Number of Patients With Successful Natural Killer Expansion|Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl.|Day 72 Post Transplant||||participants|||Number
1447467|NCT00871689|Secondary|Median Overall Survival|Average number of days the patients were alive after receiving UCB transplantation.|Month 6||||Days||Full Range|Median
1447468|NCT00871689|Primary|Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant||||participants|||Number
1447469|NCT00871689|Secondary|Number of Patients With Complete Remission of Disease|Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis).|Day 100||||Participants|||Number
1447470|NCT00871689|Secondary|Number of Patients With Transplant-Related Death (TRD)|Number of patients whose death is related to study treatment received. TRD is defined as the number of patients that die without prior relapse.|1 Year Post Transplant||||Participants|||Number
1447471|NCT00871689|Secondary|Number of Patients With Acute Graft-Versus-Host (GVHD) Disease|"Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant."|Day 100 Post Transplant||||participants|||Number
1447472|NCT00871689|Secondary|Incidence of Primary Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42.|Day 42||||Participants|||Number
1447473|NCT00871689|Primary|Number of Patients With Neutrophil Engraftment|Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.|Day 42||||Participants|||Number
1447474|NCT00871624|Secondary|Percent of Study Time Spent With a Riker-SAS Score Between 3 and 4 Inclusive|Percentage of time spent at desired sedation goal|Completed at baseline and every 4 hours after the start of NPPV therapy for the duration of the study||||percentage of time||95% Confidence Interval|Median
1447475|NCT00871624|Primary|Tolerability of NIV as Assessed by an NIV Tolerance Score|NIV tolerance (NIV intolerance score =1 out of 4) A score of 1 for a comfortable and relaxed patient tolerating NIV; a score of 2 for mild intolerance with some discomfort and occasionally grabbing at the NIV mask; a score of 3 for moderate intolerance and discomfort with the NIV mask most of the time but more frequent grabbing at the mask, sometimes pulling it off; and a score of 4 for severe NIV intolerance with agitation and the inability to leave the NIV mask in place. The outcome measure description of the time frame is reported as the average of the NIV tolerance scores reported at the various time frames (0min, 30min, 60 min, 3hr, 6hr, 12hr, and then every 12hr after the start of NIV therapy up to 72 hours)|Completed at time 0min, 30min, 60min, 3hr, 6hr, 12hr, and then every 12 hours after the start of NPPV therapy up to 72 hours||||percentage of time spent tolerant to NIV||Inter-Quartile Range|Median
1447476|NCT00871572|Secondary|Change From Baseline to Endpoint for Total Cholesterol|Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting total cholesterol measurement and analyzed according to the assigned treatment; LOCF.|||mmol/L||Standard Error|Least Squares Mean
1447477|NCT00871572|Secondary|Change From Baseline to Endpoint for Non-HDL Cholesterol|Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting non-HDL cholesterol measurement and analyzed according to the assigned treatment; LOCF.|||mmol/L||Standard Error|Least Squares Mean
1447478|NCT00871572|Secondary|Change From Baseline to Endpoint for High Density Lipoprotein (HDL)|Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting HDL measurement and analyzed according to the assigned treatment; LOCF.|||mmol/L||Standard Error|Least Squares Mean
1447479|NCT00871572|Secondary|Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)|Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting LDL measurement and analyzed according to the assigned treatment; last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
1447480|NCT00871572|Secondary|Change From Baseline for C-Peptide AUC From OGTT|LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: all randomized participants with at least 1 post baseline C-peptide AUC from OGTTmeasurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
1447481|NCT00871572|Secondary|Change From Baseline for Insulin AUC From OGTT|LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline AUC from OGTT measurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
1447482|NCT00871572|Secondary|Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting GLP-1 measurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
1447483|NCT00871572|Secondary|Change From Baseline Values for Fasting Glucagon|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting glucagon measurement and analyzed according to the assigned treatment.|||pmol/L||95% Confidence Interval|Least Squares Mean
1447484|NCT00871572|Secondary|Change From Baseline Values for Fasting Insulin|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting insulin measurement and analyzed according to the assigned treatment.|||picomole/liter (pmol/L)||95% Confidence Interval|Least Squares Mean
1447485|NCT00871572|Secondary|Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles|Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline 7-Point SMBG measurement and analyzed according to the assigned treatment.|||milligrams/deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
1447486|NCT00871572|Secondary|Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)|The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline Diabetes Medicines Survey measurement and analyzed according to the assigned treatment.|||units on a scale||Standard Deviation|Mean
1447487|NCT00871572|Secondary|Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)|The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline DSC-R measurement and analyzed according to the assigned treatment.|||units on a scale||Standard Deviation|Mean
1447488|NCT00871572|Secondary|Change From Baseline to Endpoint for Fasting Triglycerides|LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline fasting triglyceride measurement and analyzed according to the assigned treatment.|||mmol/L||Standard Error|Least Squares Mean
1447489|NCT00871572|Secondary|Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)|LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline OGTT measurement and analyzed according to the assigned treatment.|||mmol/L||95% Confidence Interval|Least Squares Mean
1447490|NCT00871572|Secondary|Change From Baseline Values for Fasting Blood Glucose (FBG)|LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|mITT: All randomized participants with at least 1 post baseline FBG measurement and analyzed according to the assigned treatment.|||millimoles/liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1447491|NCT00871572|Primary|Mean Change in Glycosylated Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.|Baseline, Week 12|Modified Intent-to-Treat (mITT): All randomized participants with at least 1 post baseline HbA1c measurement and analyzed according to the assigned treatment.|||percentage of HbA1c||90% Confidence Interval|Least Squares Mean
1447514|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.|||Subjects|||Number
1447492|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."|||percentageof participants||95% Confidence Interval|Number
1447493|NCT00871494|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of treatment, Day 15, Day 29|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1447494|NCT00871494|Secondary|Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1447495|NCT00871494|Primary|Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.~The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1447496|NCT00871429|Secondary|Percentage of Subjects With Skin Toxicity Grades 0 to 5 Using The NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 at Baseline Visit and 1 Month Follow-up After Using Lindi Products.||one month|||||||
1447497|NCT00871429|Primary|Product Satisfaction of the Following Test Articles A, B, and C: Lindi Skin Soothing Balm (Product A), Lindi Skin Face Serum (Product B), and Lindi Skin Face Wash (Product C)||one month of use|the number of participants for analysis was determined per protocol.|||Percentage of Participants|||Number
1447498|NCT00871403|Secondary|Percentage of Participants With a Complete Response or a Partial Response|The percentage of participants with a complete response or a partial response was evaluated.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population|||percentage of participants|||Number
1447499|NCT00871403|Secondary|Best Overall Response, Assessed as the Number of Participants With the Indicated Tumor Response: Investigator Assessed Only|Tumor response was assessed by the Investigator according to the RECIST, version 1.0. A participant was defined as a responder if he/she sustained a complete response (CR; the disappearance of all target lesions) or partial response (PR; >=30% decrease in the sum of the longest diameter of target lesions) for at least 4 weeks at any time during randomized treatment. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.|Randomization until response or progressive disease (up to 85 weeks)|ITT Population. A participant without a post-baseline assessment of response was considered to be a non-responder; i.e., all randomized participants are included in the denominator.|||participants|||Number
1447500|NCT00871403|Secondary|Overall Survival (OS)|OS was determined from the date of randomization to the date of death from any cause. Participants who had not died at the time of the cut-off for the final analysis were censored at the date the participants were last known to be alive. Because enrollment in the study was halted prematurely, the ability to achieve an estimate of OS was compromised. Consequently, OS was not estimated.|Randomization until death (up to 85 weeks)|ITT Population||||||
1447515|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PSC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447501|NCT00871403|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization (date on which the investigator evaluated the participant and first determined he/she had disease progression) and the first occurrence of progressive disease (PD) or death from any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST), version 1, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion).|Randomization until progression or death (up to 85 weeks)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment and who were analyzed based on the assigned randomized treatment and not based on actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||weeks||95% Confidence Interval|Median
1447502|NCT00871377|Primary|Seizure Frequency|Seizure frequency (seizures per day or seizures per month)|Study completion (42 weeks)||||Seizures per Day||Standard Error|Mean
1447503|NCT00871351|Secondary|Percent Change in Total Lipids and Hs-CRP|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).|End of washout to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
1447504|NCT00871351|Secondary|Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)|Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.|End of Week 4 to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
1447505|NCT00871351|Secondary|Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values|"LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).~Target values:~For participants with history of coronary artery disease: <100 mg/dL;~for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;~for participants with 1-2 CV risk factors: <140 mg/dL;~for participants with no CV risk factors: <160 mg/dL."|Week 16 or discontinuation|Randomized participants|||Participants|||Number
1447506|NCT00871351|Secondary|Percent Change in LDL-C|LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).|End of washout period to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
1447507|NCT00871351|Primary|Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values|LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).|End of Week 4 to Week 16 or discontinuation|Randomized participants|||Percent change||95% Confidence Interval|Mean
1447508|NCT00871338|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Month 0 to Month 11)|The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.|||Subjects|||Number
1447509|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.|||Subjects|||Number
1447510|NCT00871338|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.|||Subjects|||Number
1447511|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.|||Subjects|||Number
1447512|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Primary Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented during the primary course.|||Subjects|||Number
1447513|NCT00871338|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 8-day (Days 0-7)|The analysis was performed on the Booster Total Vaccinated cohort, which included all subjects vaccinated with the booster dose.|||Subjects|||Number
1447579|NCT00871000|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1447516|NCT00871338|Secondary|Number of Subjects With a Booster Response to Anti-PRP Antibodies.|Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447517|NCT00871338|Secondary|Number of Subjects With a Booster Response to rSBA-MenC Antibodies.|Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.|At Month 11|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447518|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||titers||95% Confidence Interval|Geometric Mean
1447519|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1447520|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||IU/mL||95% Confidence Interval|Geometric Mean
1447521|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||µg /mL||95% Confidence Interval|Geometric Mean
1447522|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||titers||95% Confidence Interval|Geometric Mean
1447523|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||µg /mL||95% Confidence Interval|Geometric Mean
1447524|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447525|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447526|NCT00871338|Secondary|Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.|A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).|At Month 10.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447527|NCT00871338|Secondary|Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447528|NCT00871338|Secondary|Number of Seropositive Subjects Against rSBA-MenC.|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447529|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-PRP.|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 10 and Month 11.|The analysis was performed on the Booster According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen for the blood sample taken 30 days after the administration of the booster vaccination course.|||Subjects|||Number
1447530|NCT00871338|Secondary|Concentrations for Anti-PNE Serotypes.|Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||µg/mL||95% Confidence Interval|Geometric Mean
1447531|NCT00871338|Secondary|Titers for Anti-polio 1, 2 and 3.|Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||titers||95% Confidence Interval|Geometric Mean
1447532|NCT00871338|Secondary|Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1447533|NCT00871338|Secondary|Concentrations for Anti-T and Anti-D.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||IU/mL||95% Confidence Interval|Geometric Mean
1447534|NCT00871338|Secondary|Concentrations for Anti-PSC.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||µg/mL||95% Confidence Interval|Geometric Mean
1447535|NCT00871338|Secondary|Titers for rSBA-MenC.|Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||titers||95% Confidence Interval|Geometric Mean
1447536|NCT00871338|Secondary|Concentrations for Anti-PRP.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||µg/mL||95% Confidence Interval|Geometric Mean
1447537|NCT00871338|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
1447538|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.|A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
1447539|NCT00871338|Secondary|Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).|A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
1447616|NCT00870740|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Hematology parameters evaluated include: white blood cells, lymphocytes, neutrophils, red blood cells (RBC), hemoglobin, and platelets.|Up to 72 Weeks|Number of participants in the safety population (all randomized participants who received study treatment) with at least one post-baseline value.|||participants|||Number
1447540|NCT00871338|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|At Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
1447541|NCT00871338|Secondary|Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.|The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
1447542|NCT00871338|Secondary|Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.|The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Subjects|||Number
1447543|NCT00871338|Primary|Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)|A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.|At Month 2 and Month 3.|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Participants|||Count of Participants
1447544|NCT00871338|Primary|Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 3|The analysis was performed on the Primary According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination course.|||Participants|||Count of Participants
1447545|NCT00871286|Primary|Number of Participants Having a CT Done|Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.|8 weeks|Per protocol; this was a nonpowered convenience sample|||participants|||Number
1447546|NCT00871286|Primary|Number of Participants in Compliance With Medical Recommendations|Number of participants in each group who complied with medical advice given at the initial appointment.|8 weeks||||participants|||Number
1447547|NCT00871234|Secondary|Endothelial Activation Biomarkers||Four weeks|||||||
1447548|NCT00871234|Secondary|Inflammatory Biomarkers||Four weeks|||||||
1447549|NCT00871234|Secondary|Blood Pressure||Four weeks|||||||
1447550|NCT00871234|Secondary|Insulin Sensitivity [(Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)]||Four weeks|||||||
1447551|NCT00871234|Secondary|Lipid Fractions||Four weeks|||||||
1447552|NCT00871234|Primary|Flow-mediated Dilation (FMD) of the Brachial Artery|FMD is measured as the percentage increase in brachial artery diameter after increase in blood flow. We measured the change in this percentage from entry (before etravirine was started) and again at four weeks after receiving etravirine.|Entry and four weeks|FMD analysis was per protocol restricted to those who completed the four week trial. The safety analysis was ITT.|||Percentage||Inter-Quartile Range|Median
1447553|NCT00871169|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events, and Serious Adverse Events (SAEs)).|2 years||||participants|||Number
1447554|NCT00871169|Primary|Overall Response Rate (ORR)|ORR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. ORR is the percentage of patients who experienced a CR + the percentage of patients who experienced a PR.|2 years||||percentage of participants||95% Confidence Interval|Number
1447555|NCT00871143|Secondary|Body Image Quality of Life Inventory (BIQLI)|The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from –3 (‘very negative effect’) to +3 (‘very positive effect’); Cronbach’s α for the scale is 0.95.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
1447556|NCT00871143|Secondary|Generalised Anxiety Disorder (GAD)-7|The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach’s α for the measure is 0.92.|12 weeks,1 month post treatment||||units on a scale||Standard Deviation|Mean
1447557|NCT00871143|Secondary|Patient Health Questionnaire (PHQ)-9|The PHQ is a 9-item self-report measure of depression; each item is scored from 0 (‘not at all’) to 3 (‘nearly every day’),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach’s α for the scale is 0.89.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
1447660|NCT00870233|Secondary|To Measure the Feasibility of Online Symptom Self-reporting in the Early Postoperative Period, and Clinician Perceptions of Its Potential Value in Routine Outpatient Post-operative Cancer Care.||once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended|9 Nurses|||Participants|||Count of Participants
1447558|NCT00871143|Secondary|Appearance Anxiety Inventory (AAI)|The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 (‘not at all’) to 4 (‘all the time’), and the range of the total scores is 0–40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach’s α of 0.86.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
1447559|NCT00871143|Secondary|Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).|MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating ‘normal’ or ‘no difficulties’) to 6, and the range is 0–60; higher scores reflect a greater symptomatology; a MADRS total score of ≥ 25 is regarded as moderate, and of >31 as severe.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
1447560|NCT00871143|Secondary|Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)|BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. ‘I am as ugly as the Elephant man’); each item is rated from 0 (‘non-delusional belief, or least pathological’) to 4 (‘delusional belief, or most pathological’) and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
1447561|NCT00871143|Primary|Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)|This is a clinician-rated scale administered by a trained blinded assessor. The range is 0–48. Cronbach’s α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to ‘much improved’ on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.|12 weeks, 1 month post treatment||||units on a scale||Standard Deviation|Mean
1447562|NCT00871117|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 to 6 months post-vaccination)|Analysis was performed on the total vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data was available.|||Participants|||Count of Participants
1447563|NCT00871117|Secondary|Number of Subjects With Unsolicited Adverse Events|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|Analysis was performed on the total vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data was available.|||Participants|||Count of Participants
1447564|NCT00871117|Secondary|Number of Subjects With Any Solicited General Symptoms|Solicited general symptoms included fever [temperature equal to or greater than 37.5 degrees Celsius (°C)], drowsiness and loss of appetite. Any was defined as incidence of a particular symptom regardless of intensity grade.|Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|The analysis was performed on the total vaccinated cohort, which included subjects with at least one vaccine administration documented, only on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1447565|NCT00871117|Secondary|Number of Subjects With Any Solicited Local Symptoms|Solicited local symptoms included pain, redness and swelling at the injection site. Any was defined as incidence of a particular symptom regardless of intensity grade.|Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax|The analysis was performed on the total vaccinated cohort, which included subjects with at least one vaccine administration documented, only on subjects with their symptom sheets completed.|||Participants|||Count of Participants
1447566|NCT00871117|Secondary|Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies|Seropositivity was defined as a concentration greater than or equal to 5.0 EL.U/mL|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1447567|NCT00871117|Secondary|Number of Subjects Protected Against Poliovirus 1, 2 and 3|"Seroprotection was defined:~* anti-poliovirus type 1, 2 or 3 antibody titer greater than or equal to 8 ED50.~ED50 is defined here as the reverse of the dilution resulting in 50% inhibition."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1447568|NCT00871117|Secondary|Number of Subjects Seroprotected Against Diphteria and Tetanus|"Seroprotection status was defined as:~anti-D antibody concentration greater than or equal to 0.1 IU/mL~anti-T antibody concentration greater than or equal to 0.1 IU/mL"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1447569|NCT00871117|Secondary|Number of Subjects With an Anti-polio 1, 2, 3 Booster Response|"Anti-poliovirus 1, anti-poliovirus 2 and anti-poliovirus 3 booster response:~initially seronegative subjects (pre-booster antibody titer below cut-off of 8 ED50) with an antibody titer ≥ 32 ED50 one month after vaccination~initially seropositive subjects (pre-booster antibody titers ≥ 8 ED50) with an increase at least four times the pre-booster antibody titer one month after vaccination.~ED50 is defined here as the reverse of the dilution resulting in 50% inhibition. The lowest dilution at which serum samples were tested is 1:8 from which a test was considered positive."|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1447570|NCT00871117|Secondary|GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies|Concentrations are expressed as GMCs in Enzyme-Linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1447571|NCT00871117|Secondary|Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies|Concentrations were expressed as GMCs in IU/mL.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1447572|NCT00871117|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value|Cut-off value was defined as greater than or equal to 1.0 international units per milliliter (IU/mL).|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1447573|NCT00871117|Primary|Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3|Titers are expressed as GMTs.|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||titer||95% Confidence Interval|Geometric Mean
1447574|NCT00871117|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL)|"anti-PT, anti-FHA and anti-PRN booster response :~initially sero- (pre-booster antibody concentration below cut-off < 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL)~initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and < 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster~initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1447575|NCT00871117|Primary|Number of Subjects With Booster Responses to Diphteria and Tetanus|"Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as:~initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of < 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL)~initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination"|One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.|Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1447576|NCT00871000|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (from Month 0 to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1447577|NCT00871000|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1447578|NCT00871000|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1447580|NCT00871000|Secondary|Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella|Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447581|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN|Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL, an increase in antibody concentrations of at least four times the pre-vaccination concentration. For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL, an increase in antibody concentrations of at least two times the pre-vaccination concentration.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447582|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3|Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447583|NCT00871000|Secondary|Number of Subjects With Booster Responses to Anti-D and Anti-T|Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL). For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL), an increase in antibody concentrations of at least four times the pre-vaccination concentration.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447584|NCT00871000|Secondary|Anti-rubella Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1447585|NCT00871000|Secondary|Anti-mumps Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||U/mL||95% Confidence Interval|Geometric Mean
1447586|NCT00871000|Secondary|Anti-measles and Anti-varicella Antibody Concentrations|Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1447587|NCT00871000|Secondary|Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella|Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447588|NCT00871000|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447589|NCT00871000|Secondary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1447590|NCT00871000|Secondary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447591|NCT00871000|Primary|Number of Seropositive Subjects for Anti-D and Anti-T Antibodies|A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447592|NCT00871000|Primary|Number of Seroprotected Subjects Against Polio Types 1, 2 and 3|A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Participants|||Count of Participants
1447593|NCT00871000|Primary|Anti-poliovirus Types 1, 2 and 3 Antibody Titres|Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.|At Month 1, one month post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||Titers||95% Confidence Interval|Geometric Mean
1447594|NCT00871000|Primary|Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.|At Month 1, one month post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1447595|NCT00870896|Secondary|Change in FEV1/FVC Ratio|We measured the change in FEV1/FVC ratio at baseline and following 30 days of treatment with Spiriva.Change in ratio reflects the percentage value (ratio) at 30 days minus the percentage value (ratio) at baseline x 100|30 days||||percentage change||Standard Deviation|Mean
1447596|NCT00870896|Secondary|Change in FEV1 (in Liters)|Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.|||liters||Standard Deviation|Mean
1447597|NCT00870896|Primary|Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days)|We measured the change in the number of coughs following capsaicin inhalation challenge from baseline followed by 30 days of treatment with spiriva|30 days|Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.|||coughs per dose of capsaicin||Standard Deviation|Mean
1447598|NCT00870870|Secondary|Cmin of Cixutumumab for Cycle 5||Week 13 (Cycle 5, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447599|NCT00870870|Secondary|Cmin of Cixutumumab for Cycle 3||Week 7 (Cycle 3, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447600|NCT00870870|Secondary|Cmin of Cixutumumab for Cycle 1||Week 1 (Cycle 1, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447601|NCT00870870|Secondary|Minimum Concentration (Cmin) of Cixutumumab at Study Day 1||Day 1|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447602|NCT00870870|Secondary|Cmax of Cixutumumab Cycle 5||Week 13 (Cycle 5, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447603|NCT00870870|Secondary|Cmax of Cixutumumab for Cycle 3||Week 7 (Cycle 3, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447604|NCT00870870|Secondary|Cmax of Cixutumumab for Cycle 1||Week 1 (Cycle 1, Day 1)|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447605|NCT00870870|Secondary|Maximum Concentration (Cmax) of Cixutumumab at Study Day 1||Day 1|Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.||||||
1447606|NCT00870870|Secondary|Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)||Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy|Zero participants analyzed. Analysis was not performed due to lack of an appropriate validated assay.||||||
1447607|NCT00870870|Secondary|Number of Participants With Adverse Events (AEs) or Deaths|Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.|Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up|All randomized participants.|||Participants|||Count of Participants
1447608|NCT00870870|Secondary|Duration of Response|The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.|Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)|All pts randomized to GCiC and GCiC Plus Cixutumumab arms and who had CR or PR, except 1 pt in GCiC group eliminated d/t PR after starting additional treatment. Participants censored: GCiC = 0, GCiC Plus Cixutumumab = 1. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) due to the amended protocol.|||months||95% Confidence Interval|Median
1447609|NCT00870870|Secondary|Time To Progression (TTP)|TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.|Randomization to months until PD or censor (up to 16.9 months)|All participants (pts) randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 9, GCiC Plus Cixutumumab = 12. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||months||95% Confidence Interval|Median
1447610|NCT00870870|Secondary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.|Randomization to PD or death due to any cause or censor (up to 16.9 months)|All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 2, GCiC Plus cixutumumab = 10. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||months||95% Confidence Interval|Median
1447611|NCT00870870|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.|Randomization to death due to any cause or censor (up to 30.4 months)|All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 6, GCiC Plus cixutumumab = 6. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||months||95% Confidence Interval|Median
1447612|NCT00870870|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated * 100.|Randomization to measured progressive disease (PD) (up to 16.9 months)|All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.|||percentage of participants||95% Confidence Interval|Number
1447613|NCT00870740|Secondary|Rate of Percentage Change From Baseline in Mean Total Brain Volume|Total brain volume was measured by MRI and analyzed by a central reader. Rate of percentage change from baseline calculated using an analysis of covariance adjusting for baseline normalized brain volume. Baseline values = baseline for study 205MS202 (NCT00870740). Missing values post-baseline were imputed using the average value across subjects in the treatment group.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.|||rate of percentage change||95% Confidence Interval|Number
1447614|NCT00870740|Primary|Number of Participants With Development of Anti-DAC Antibodies (ADAb) and Neutralizing Antibodies (NAb) Post-baseline|Number of participants positive and negative for ADAb and NAb, based on all post-baseline immunogenicity assessments during treatment period and follow-up. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|All participants in the Safety Population (all randomized participants who received study treatment) with a post-baseline ADAb assessment.|||participants|||Number
1447615|NCT00870740|Primary|Number of Participants With Abnormalities in Blood Chemistry Laboratory Data|For each abnormality a subject can be counted once. If a subject has more than one occurrence of the same abnormality the highest toxicity grade is counted. ALT=alanine aminotransferase; AST=aspartate aminotransferase; ALP=alkaline phosphatase; GGT=gamma-glutamyl transferase; TSH=thyroid stimulating hormone, ULN=upper limit of normal.|Up to 72 Weeks|Safety Population: all randomized participants who received study treatment; n=number of participants whose baseline value for 205MS202 (NCT00870740) was normal (i.e. not high or low) and who had at least one post-baseline value during the study.|||participants|||Number
1447661|NCT00870233|Primary|Feasibility of Electronic Capture of Patient-reported Symptoms From Home Following Major Gynecologic Cancer Surgery||once pre-operatively and then weekly starting 7 days after surgery until the 6-week post-operative period has ended.||||Participants|||Count of Participants
1447617|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Volume of Non-gadolinium (Gd)-Enhancing T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all participants within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.|||percentage change in volume||Standard Deviation|Mean
1447618|NCT00870740|Secondary|Mean Percentage Change From Baseline in Total Lesion Volume of T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. Baseline values = baseline for study 205MS202 (NCT00870740). For post-baseline visits, the total volume of T2 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 52|Per-protocol population (with a baseline and post-baseline assessment): randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days.|||percentage change in volume||Standard Deviation|Mean
1447619|NCT00870740|Secondary|Mean Volume of New T1 Hypointense Lesions|T1-weighted scans detect areas of hypointensity that represent a greater degree of tissue destruction and axon loss than T2 hyperintense lesions and are more highly correlated with clinical disability measures and neurological deficit. Evaluated by MRI by a central reader. Baseline is volume of new T1 hypointense lesions since baseline in study 205MS201 (NCT00390221). Scans at Week 20 and Week 52 in 205MS202 are relative to baseline in 205MS202 (NCT00870740). For post-baseline visits, the total volume of T1 lesions may be imputed using the mean value across all subjects within the treatment group. Baseline visits are not imputed.|Baseline, Week 20, Week 52|Per-protocol population: randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was ≥ 56 days; n=participants with measurement at given time point.|||mm^3||Standard Deviation|Mean
1447620|NCT00870740|Secondary|Mean Number of New or Newly-enlarging T2 Hyperintense Lesions|Lesions detected on T2-weighted sequences represent a range of histopathology related to MS, including edema, inflammation, demyelination, gliosis, and axon loss. Evaluated by MRI by a central reader. New or newly enlarging T2 lesions since baseline of study 205MS202 (NCT00870740). For post-baseline visits, the number of T2 lesions may be imputed using the mean value across all participants within the treatment group, if the participant has non-missing baseline data. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Baseline, Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||lesions||Standard Deviation|Mean
1447621|NCT00870740|Secondary|Mean Number of New Gadolinium-enhancing Lesions|Evaluated by magnetic resonance imaging (MRI) by a central reader. Number of new Gd lesions since the previous scan (the previous scan for Week 20 was Week 52 of study 205MS201 [NCT00390221]). The number of Gd lesions may be imputed using last observation carried forward or using the mean value across all subjects within the treatment group. Baseline visits are not imputed. Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Week 20, Week 52|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||lesions||Standard Deviation|Mean
1447622|NCT00870740|Secondary|Estimated Proportion of Participants With a Relapse|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the INEC. Estimated using Kaplan-Meier analysis where time to first relapse is calculated from date of first dose in the study to date of first confirmed relapse. Participants who received an alternative MS medication before the first relapse were censored at the time of taking the alternative MS medication.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||proportion of participants|||Number
1447623|NCT00870740|Secondary|Adjusted Annualized Relapse Rate|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Independent Neurology Evaluation Committee (INEC). Relapse rate is calculated as: (Total number of relapses that occurred during the 205MS202 [NCT00870740] treatment phase divided by the total number of days followed in the treatment phase for 205MS202), multiplied by 365 days. Participants who received an alternative multiple sclerosis (MS) medication during 205MS201 (NCT00390221; Year 1) are not included in the summary of relapses and relapse rate for this study (Year 2). Participants are stratified differently in this Outcome Measure as per the pre-specified statistical analysis plan.|Up to 72 weeks|Per-protocol population: all randomized participants who received study treatment, excluding 18 participants from a single site (protocol violation) plus 75 participants for whom the time between the last dose of study treatment in 205MS201 (NCT00390221) and the first dose in 205MS202 (NCT00870740) was 56 days or longer.|||relapses per person-years||95% Confidence Interval|Number
1447869|NCT00868140|Primary|Fasting Serum Insulin|Fasting serum insulin (uIU.min/ml) measured at 0, 60 and 120 minutes of a 2 hour OGTT before treatment with either pioglitazone or placebo|baseline||||uIU.min/ml||Standard Error|Mean
1447624|NCT00870740|Primary|Number of Participants With Abnormalities in Vital Signs|For participants who took DAC HYP during 205MS201 (NCT00390221) the baseline is defined as the baseline from 205MS201, and for participants who took placebo during 205MS201 the baseline is defined as the baseline from 205MS202 (NCT00870740). All post-baseline data are taken after first dose in 205MS202 only. SBP=systolic blood pressure; DBP=diastolic blood pressure; bpm=beats per minute; ↑ BL=increase from baseline; ↓ BL=decrease from baseline.|Up to Week 72|Safety population: all randomized participants who received study treatment; n=number of subjects who had a baseline assessment and at least one post-baseline assessment for that vital sign.|||participants|||Number
1447625|NCT00870740|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Treatment-emergent AE: any untoward medical occurrence after the first dose of study treatment that did not necessarily have a causal relationship with this treatment. Serious AE (SAE): any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE could also have been a medically significant event that, in the opinion of the Investigator, jeopardized the subject or required intervention to prevent one of the other outcomes listed in the definition above.|Up to 72 weeks|Safety population: all randomized participants who received study treatment. Participants who discontinued study treatment due to an AE and/or withdrew from the study due to an AE that started prior to 205MS202 (NCT00870740) and that was treatment-emergent under 205MS201 (NCT00390221) are included in this summary.|||participants|||Number
1447626|NCT00870688|Primary|Number of Seizures Within 7 Weeks||7 weeks||||seizures||Standard Deviation|Mean
1447627|NCT00870688|Secondary|Data About Efficacy, Safety and Compliance||7 weeks|||||||
1447628|NCT00870688|Primary|Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily||7 weeks|||||||
1447629|NCT00870584|Secondary|Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks|"The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study? The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment."|24 weeks|Full Analysis Set|||participants|||Number
1447630|NCT00870584|Primary|Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment|The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.|Baseline and 24 weeks|"The Full Analysis Set consisted of patients to whom study drug had been assigned through randomization. Patients inappropriately randomized were excluded from this analysis set.~Participants with observations at both baseline and 24 weeks were included in the analysis."|||Score on a scale||Standard Deviation|Mean
1447631|NCT00870545|Secondary|Family Communication|Family communication measured with the Family Problem Solving Communication scale at baseline, six and 12 months. Scores range from 0-30 with higher scores indicating better communication.|baseline, 6 months, and 12 months|All participants with family communication data at baseline, six and 12 months.|||units on a scale||Standard Deviation|Mean
1447632|NCT00870545|Secondary|Spouse Social Support|Support measured with the Social Support Index at baseline, six and 12 months. Scores range from 0-68 with higher scores indicating better social support.|baseline, 6 months, and 12 months|All participants with social support data at baseline, six and 12 months.|||units on a scale||Standard Deviation|Mean
1447633|NCT00870545|Primary|Quality of Marriage|Measure of marriage quality using Quality Marriage Index at baseline, six and 12 months. Scores range from 6-45 with higher scores indicating better quality of marriage.|Baseline, 6 and 12 months|All participants with quality marriage index scores at the three time points|||units on a scale||Standard Deviation|Mean
1447634|NCT00870545|Primary|Anxiety|Anxiety measured with the Generalized Anxiety Disorder -7 (GAD-7)measured at baseline, six and 12 months. Scores range from 0-21, with lower scores indicating fewer anxiety symptoms.|baseline, 6 months and 12 months|All participants with anxiety scores at 12 months|||units on a scale||Standard Deviation|Mean
1447635|NCT00870545|Secondary|Family Coping|Family problem solving measured at baseline, six and 12 months with the F-COPES measure. Scores range from 29-145 with higher scores indicating better coping.|Baseline, 6 months and 12 months|All participants with family coping data at baseline, six and 12 months.|||units on a scale||Standard Deviation|Mean
1447636|NCT00870545|Primary|Spouse Self-report of Depression|Depression measured with the Patient Health Questionnaire (PHQ)-9 at baseline, six and 12 months. Scores range from 0-27 with lower scores indicating less depressive symptoms.|Baseline, 6 months, and 12 months|All participants with depression data at baseline, six and twelve months|||units on a scale||Standard Deviation|Mean
1447637|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.|Through Week 52|Participants who received at least 1 dose of adalimumab during the study.|||participants|||Number
1447662|NCT00870194|Secondary|Incidence of Confirmed Hypoglycemia(Overall)|Incidence of confirmed hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; has a concurrent fingerstick blood glucose <3.0 mmol/L (54 mg/dL).|||Participants|||Number
1447663|NCT00870194|Secondary|Incidence of Nocturnal Hypoglycemia (Overall)|Incidence of nocturnal hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients|||Participants|||Number
1447638|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
1447639|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||units on a scale||Standard Deviation|Mean
1447640|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
1447641|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
1447642|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.|Week 52|Participants who completed the first 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||participants|||Number
1447643|NCT00870467|Secondary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 52|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 52|Participants who completed 26 weeks and received at least 1 dose of adalimumab after Week 26. Analysis performed using observed cases; no imputation technique used.|||units on a scale||Standard Deviation|Mean
1447644|NCT00870467|Secondary|Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26|Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.|Through Week 26|All participants who received at least 1 dose of double-blind study drug.|||participants|||Number
1447645|NCT00870467|Secondary|Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
1447646|NCT00870467|Secondary|Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26|Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Last observation carried forward (LOCF) was used for missing data.|||units on a scale||Standard Deviation|Mean
1447735|NCT00869414|Primary|Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)||6 weeks|This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available.||||||
1447647|NCT00870467|Secondary|Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
1447648|NCT00870467|Secondary|Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
1447649|NCT00870467|Secondary|Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)|Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.|Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Non-responder imputation (NRI) performed.|||participants|||Number
1447650|NCT00870467|Primary|Change From Baseline in Modified Total Sharp X-Ray Score at Week 26|Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.|Baseline, Week 26|All participants who received at least 1 dose of double-blind study drug and had at least 1 efficacy assessment during double-blind study drug treatment. Analysis performed using observed cases; no imputation technique used. Participants who switched to open-label adalimumab before Week 26 were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1447651|NCT00870363|Secondary|Immune Reconstitution With Respect to Absolute Numbers of CD4+ T-cells, the Relative Proportion of T-cell Subpopulations in the Tissue, and Immune Activation to a Cohort of Normal Controls||nine months|data was not collected/analyzed due to complications in the assays for immune activation in the collected samples||||||
1447652|NCT00870363|Secondary|Changes in CD4+ T-cell Numbers by Treatment Regimen|peripheral absolute CD4+ T-cell counts increase from baseline to 9 months of cART by commercial assay|Baseline and nine months|peripheral CD4 T-cell counts were not measured in the HIV negative cohort|||cells/mL||95% Confidence Interval|Mean
1447653|NCT00870363|Secondary|Lymphocyte Immune Function and Activation at Two Time Points Approximately Nine Months Apart in GALT; and Four Timepoints (Month 0, 3, 6, and 9) in Peripheral Blood||nine months|data were not collected due to inadequate sample volume for this complex experiment design||||||
1447654|NCT00870363|Secondary|Change in GALT CD4+ and CD8+ T-cell Subpopulations (naïve and Memory Subsets)||nine months|data were not collected due to the samples not being suitable for the epitopes being measured||||||
1447655|NCT00870363|Secondary|Change in HIV DNA Per 10^6 Cells in Duodenal Tissue Versus PBMC by Drug Regimen Received|single-cell suspension of digested duodenal tissue and Ficol-Hypaque separated PBMC underwent HIV-DNA PCR|Baseline and nine months|HIV negative controls did not have HIV-DNA in blood or tissue|||copies/10^6 cells||95% Confidence Interval|Mean
1447656|NCT00870363|Secondary|Trough Plasma and Tissue Drug Levels in Volunteers at the Time of the Upper Endoscopy|The reported drug level is for the primary ART agent for that cohort. For the maraviroc arm, maraviroc plasma and tissue levels are reported. For the maraviroc plus raltegravir arm, the raltegravir plasma and tissue levels are reported. For the efavirenz arm, the efavirenz plasma and tissue levels are reported. HIV negative controls were not on ART and did not have drug levels measured.|nine months|HIV negative controls were not on ART and did not have drug levels measured.|||ng/mL||Inter-Quartile Range|Median
1447657|NCT00870363|Primary|Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen|immunohistochemistry for CD3+/CD4+ cells counted manually within the lamina propria|Baseline and nine months for 3 treatment cohorts and Baseline for the control group, which was only assessed at one time point|numbers represent an increase from baseline for the 3 treatment cohorts and represent the absolute value for the control group who were only measured at one timepjoint.|||cells/mm^2||95% Confidence Interval|Mean
1447658|NCT00870233|Secondary|Most Commonly Reported and Most Distressing Symptoms Reported by Patients After Gynecologic Cancer Surgery Using the STAR System|The percentage of symptoms generated by patients on protocol|weekly starting 7 days after surgery until the 6-week post-operative period||||percentage of symptoms|||Number
1447659|NCT00870233|Secondary|To Evaluate the Impact of Online Symptom Self-reporting on Patient Care Processes as Measured by the Number of Telephone Calls Between Nurses and Patients,Resulting Interventions and Patient Satisfaction With Care Delivery.||two years|Data were not collected||||||
1447754|NCT00869167|Secondary|Daytime Lung Function (Peak Flow Monitoring) in Liter/Min||baseline and during treatment period (during 5th week)|This measure was added during the study and no subjects completed the measure.||||||
1447664|NCT00870194|Secondary|Incidence of Severe Hypoglycemia(Overall)|Incidence of severe hypoglycemia experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Severe hypo:symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose;or documented hypoglycemia (BG< 3.0 mmol/L [54/mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior|||Participants|||Number
1447665|NCT00870194|Secondary|Incidence of Hypoglycemia (Overall)|Incidence of hypoglycemic episodes experienced overall during the study|Baseline to 20 Weeks|As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; not confirmed with blood glucose values.|||Participants|||Number
1447666|NCT00870194|Secondary|Change in Total Cholesterol (mmol/L)|Change in total cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
1447667|NCT00870194|Secondary|Change in LDL (mmol/L)|Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
1447668|NCT00870194|Secondary|Change in HDL (mmol/L)|Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
1447669|NCT00870194|Secondary|Change in Triglycerides (mmol/L)|Change in triglycerides from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
1447670|NCT00870194|Secondary|SMBG (mmol/L)|7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
1447671|NCT00870194|Secondary|Waist-to-Hip Ratio|Change in waist-to-hip ratio from baseline to endpoint (Week20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Ratio||Standard Error|Least Squares Mean
1447672|NCT00870194|Secondary|Change in Waist Circumference (cm)|Change in waist circumference from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||cm||Standard Error|Least Squares Mean
1447673|NCT00870194|Secondary|Change in Body Weight (kg)|Change in body weight from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||kg||Standard Error|Least Squares Mean
1447674|NCT00870194|Secondary|Change in FSG (mmol/L)|Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||mmol/L||Standard Error|Least Squares Mean
1447675|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 6.5%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage|||Number
1447676|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <7.0%|Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was >= 7.0%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage|||Number
1447677|NCT00870194|Secondary|Percentage of Patients Achieving HbA1c <=7.0%|Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)|Baseline to 20 Weeks|Patients in the Per Protocol Set whose baseline HbA1c was > 7.0%; Last Observation Carried Forward.Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage|||Number
1447678|NCT00870194|Primary|Change in HbA1c (Percent)|Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]|Baseline to 20 Weeks|Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percent HbA1c||Standard Error|Least Squares Mean
1447679|NCT00870103|Primary|The Percentage of Patients With no Ocular Pain||Day 15 after cataract surgery||||Percentage of participants|||Number
1447791|NCT00868608|Secondary|Kaplan-Meier Estimates of the Probability of Survival at 6, 12 and 24 Months in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|6, 12 and 24 months|ITT population.|||Probability||95% Confidence Interval|Number
1447680|NCT00870103|Primary|The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.|"The percentage of patients with a score of zero for Anterior chamber cells.~Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).~Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon"|Day 15 after cataract surgery||||Percentage of participants|||Number
1447681|NCT00869999|Primary|Overall Response Rate|Complete response plus partial response after 6 cycles. Response rate will be evaluated by using the modified Cheson criteria for lymphoma response. Complete response requires all of the following: 1) PET positive prior to therapy: mass of any size permitted if PET negative. Variable FDG-avid or PET negative prior to therapy: regression to normal size on CT (</= 1.5cm in their greatest transverse diameter for nodes >/= 1.5 cm before therapy) 2) Spleen (if enlarged before therapy) must have regressed in size and must not be palpable, 3) If bone marrow is known to be involved, repeat biopsy documents clearance. Partial response requires 1) >/= 50% decrease in SPD, 2) No new sites of disease or increase in the size of other nodes, liver or spleen, 3) Splenic and hepatic nodules must regress by at least 50% in SPD|Assessed at the conclusion of cycle 2, cycle 4 and cycle 6||||percentage of participants||90% Confidence Interval|Number
1447682|NCT00869999|Secondary|Progression-free Survival|Progression-free survival is defined as the duration of time from start of treatment to time of documentation of progression or death|2 years||||months||90% Confidence Interval|Median
1447683|NCT00869999|Secondary|Duration of Overall Response|Duration of overall response is measured from the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.|2 years||||months||90% Confidence Interval|Median
1447684|NCT00869960|Primary|Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447685|NCT00869960|Primary|Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447686|NCT00869960|Primary|Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447687|NCT00869960|Primary|Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447688|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447689|NCT00869960|Primary|Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|Between time of dosing to 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447690|NCT00869960|Primary|Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase).|between time of dosing tp 24 hours after dose administration|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447691|NCT00869960|Primary|Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)|Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase).|between time of dosing to 24 hours after dose administered|The number was determined based upon the those women who completed the study.|||mg*h/L||Standard Deviation|Mean
1447692|NCT00869947|Secondary|Trailing Leg Step-to-step Transition Work|We calculated step-to-step transition work, the work done by each individual leg on the center of mass during transitions, using the individual limbs method described by Donelan et al. 2002. Trailing leg step-to-step transition work quantifies the amount of push-off work done by the trailing leg when both feet are on the ground during walking. Work (J) is normalized to each subject's mass (kg).|1 year||||J/kg||Standard Error|Mean
1447693|NCT00869947|Secondary|Preferred Walking Velocity|We determined preferred walking velocity by incrementally increasing and decreasing treadmill velocity until each participant ascertained the velocity that they felt most comfortable.|1 year||||m/s||Standard Deviation|Mean
1447694|NCT00869947|Primary|Metabolic Cost of Transport|We measured and compared gross rates of oxygen consumption and carbon dioxide production using a portable metabolic analysis system (Cosmed K4b2, IT) while participants walked at five constance velocities (0.75, 1.00, 1.25, 1.50 and 1.75 m/s) on a level treadmill (SoleFitness F85). We calculated average steady-state metabolic power in Watts (W) from 4-6 min of each trial using a standard equation. Then, we divided the metabolic power by each participant's weight and velocity to calculate the metabolic cost of transport (J/Nm).|1 year||||J/Nm||Standard Deviation|Mean
1447695|NCT00869791|Secondary|"Off Time Hours Reported by Subjects Using Parkinson's Patient Diary"|Subjects recorded state of ”OFF” time using the Parkinson's Patient Diary|Last 3 days of each treatment period, every 30 minutes over a 24-hour day beginning at 6:00 AM|All treated patients|||hours||Standard Deviation|Mean
1447696|NCT00869791|Secondary|Result Summary of Day 1 Dyskinesia Evaluated by Investigator Assessment for Each Treatment Period|"To determine 8h efficacy on Day 1 the on site investigator assessments of ON, OFF and state of dyskinesia for each subject was collected predose (-1, -0.5, and 0 hours) every 30 min for up to 8 hours after dosing . For all subjects duration of (1) OFF time (2) ON time without dyskinesia, (3) ON time with non-troublesome dyskinesia and (4) ON time with troublesome dyskinesia was calculated for both treatments. Definition of “ON” was based on a 20% change from predose measure, and the results were analyzed in the standard manner of a two way crossover design. The trial inclusion criteria included ability of subject to differentiate “ON” state from “OFF” state per investigator’s assessment."|Predose and then every 30 min upto 8 h after dosing on Day of 1 of each treatment period|For determining motor assessment of dyskinesia evaluated by investigator assessment a mixed-effect model was used with treatment, sequence, and period as factors and subjects within sequence as error term. The primary analysis was performed on the average of all times collected half hourly. Data for two patients was not collected, N25 instead of 27|||Hours||Standard Deviation|Mean
1447697|NCT00869791|Secondary|8-Hour Efficacy Using Day 1 Unified Parkinson’s Disease Rating Scale Part III Score|To determine efficacy on Day 1 the UPDRS (unified Parkinson's disease rating) Part III score, a clinician-scored measure of motor function, was collected immediately predose and 1, 2, 3, 4, 5, 6, 7 and 8 h post dose. The UPDRS Part III motor exam analyzes multiple motor functions like speech, facial expression, tremor, rigidity, movement, posture, gait etc. Each parameter is assigned values from 0 to 4, with 0 being normal and 4 being the most affected. The total range is 0 - 108, with lower scores indicating a better outcome.The average of post dose was calculated for day 1.|Pre dosing and at hourly intervals through the 8-hour measurement period on day 1|Analysis of covariance was the primary analysis conducted on the mean UPDRS Part III across the 8-hour measurement period, with the predose UPDRS Part III value as a covariate. This analysis was repeated at each timepoint for completeness.|||UPDRS Part III Motor Score||Standard Deviation|Mean
1447698|NCT00869791|Secondary|8-Hour Efficacy Using Day 1 Tapping|"Improvement in Tapping: has been used as a surrogate endpoint for assessing subject being “On. Finger Tapping: the number of times the subject could tap two counter keys 20 cm apart alternately in 1 minute with the most affected arm assessed every 30 minutes on Day 1. Subjects performed the 60-second tapping measurement three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period on Day 1 of each treatment period. More hours “On” during treatment represented better outcome. For the Tapping measurement, the protocol defined a 20% change from the average of the predose measurements as the time to “On.” Each half-hour interval counted as 0.5 hour. Any measurement below a 20% improvement was considered time “Not On.” If patient required redosing then primary analyses adjusted for redosing in calculating the results."|Day 1 of each treatment period - three times prior to dosing in the clinic, and at half-hour intervals through the 8-hour measurement period|Analysis of covariance was the primary analysis conducted on the mean total Taps across the 8-hour measurement period, with the average of the three predose Tapping measurement values as a covariate.|||Hours||Standard Deviation|Mean
1447699|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Area Under the Concentration-time Curve for the Dosing Interval for LD and CD Concentrations From Blood Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Area under the concentration-time curve for the dosing interval (AUC Tau) in hour*nanogram/milliliter was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.|||hour*nanogram/milliliter||Standard Deviation|Mean
1447700|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Tmax for Levodopa and Carbidopa Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Time of maximum drug concentration (Tmax in hours) was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm2 (CD-LD IR first, washout, then IPX066|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD. 14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.|||Hours||Standard Deviation|Mean
1447701|NCT00869791|Primary|Pharmacokinetics Measurements to Determine Cmax for Carbidopa (CD) and Levodopa (LD) Plasma Concentrations From Samples Collected Pre-dose and at Different Time Points on Day 1 and Day 8 of Periods 1 and 2 of Both Treatment Arms.|For both treatment arms: Sequence 1 (IPX066, Washout, then IR CD-LD) and Sequence 2 (IR CD-LD, Washout, IPX066), blood samples for measurement of LD and CD plasma concentrations were collected pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, and 8 hours after dosing on Day 1 (referred to as Single-Dose data); and at pre-dose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours after dosing on Day 8 (referred to as Multiple-Dose data). Maximum (peak) drug concentration (Cmax in nanograms/milliliter) was estimated using Single-Dose data and Multiple-Dose data.|Day 1 and on Day 8 after a week of intervention in each treatment arm: Arm 1 (IPX066 first, washout, then CD-LD IR) and Arm 2 (CD-LD IR first, washout, then IPX066)|The study was designed to assess the single and multiple-dose PK and PD of IPX066 and IR CD-LD in subjects with advanced PD.14 subjects first received IPX066 (Period 1), then IR CD-LD (Period 2). 13 Subjects first received IR CD-LD (Period 1), then IPX066 (Period 2). All 27 subjects that were treated in the study were included in the PK analyses.|||nanogram/milliliter||Standard Deviation|Mean
1447702|NCT00869778|Secondary|Change From Baseline by Visit for Serum HBV DNA|Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values|week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||IU/mL||Standard Deviation|Mean
1447703|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
1447704|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
1447705|NCT00869778|Secondary|Change From Baseline by Visit for HBeAg Titer|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population|||IU/mL||Standard Deviation|Mean
1447706|NCT00869778|Secondary|The Proportion of Patients With Positive Anti-HBe||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population|||percentage of participants|||Number
1447707|NCT00869778|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb;||at week 12, 28, 32, 40, 52, 64, 76.|Intent-to-treat population|||percentage of participants|||Number
1447708|NCT00869778|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
1447709|NCT00869778|Secondary|The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;||week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
1447710|NCT00869778|Secondary|Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76|HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication|serology response at week 12, 28, 32, 40, 52, 64, 76|Intent-to-treat population|||percentage of participants|||Number
1447711|NCT00869778|Primary|Percentage of Participants With HBeAg Seroconversion at Endpoint .|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint(LOCF), up to 76 Weeks|Intention-To-Treat Population|||percentage of participants|||Number
1447712|NCT00869622|Secondary|Vertebral Fractures||2 years||||Vertebral Fractures|||Number
1447713|NCT00869622|Primary|Changes in Bone Mineral Density|"Patients with a T-Score of > -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D.~Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals."|2 years|The study design involved 80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate. This is a prospective study in which 80 patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.|||g/cm2||Standard Deviation|Mean
1447714|NCT00869609|Secondary|Change in Waist Circumference|Waist circumference was measured at the midpoint between the lower rib margin and the iliac crest; the measurement was repeated twice and the average computed.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||inches||Standard Deviation|Mean
1447715|NCT00869609|Secondary|Change in Diastolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mmHg||Standard Deviation|Mean
1447716|NCT00869609|Secondary|Change in Systolic Blood Pressure|Blood pressure was measured in a sitting position in the right arm after resting for five minutes. First appearance and last heard (phase V) Korotkoff's sounds were used to define the pressure readings; the measures were repeated twice with a thirty second wait between each reading.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mmHg||Standard Deviation|Mean
1447717|NCT00869609|Secondary|Change in Glycosylated Hemoglobin A1c (HbA1c)|Collected via venous blood draw, the HbA1c level reflects glucose concentration over the previous period (approximately 8-12 weeks, depending on the individual) and provides an indication of long-term glycemic control.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1447718|NCT00869609|Secondary|Change in Fasting Glucose|Fasting plasma glucose was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mg/dl||Standard Deviation|Mean
1447719|NCT00869609|Secondary|Change in Triglycerides|Triglycerides were measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with relevant medication changes were excluded.|||mg/dl||Standard Deviation|Mean
1447720|NCT00869609|Secondary|Change in LDL Cholesterol|Low-density lipoprotein (LDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.|||mg/dl||Standard Deviation|Mean
1447721|NCT00869609|Secondary|Change in HDL Cholesterol|High-density lipoprotein (HDL) cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.|||mg/dl||Standard Deviation|Mean
1447722|NCT00869609|Secondary|Change in Total Cholesterol|Total cholesterol was measured after at least an eight-hour fast using the Cholestech LDX System by a certified research assistant.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Participants with medication changes relevant to the outcome were excluded.|||mg/dl||Standard Deviation|Mean
1447723|NCT00869609|Primary|Change in Weight|Weight was measured twice without shoes with the average computed; participants were asked to remove their shoes at each measure.|Measured at 8 months post intervention and 4 months post-randomization to maintenance group|Intention to treat analyses were performed; for those with missing weights at the post-intervention, 8 and 12 month visits, the last documented observation was carried forward. This information was available from the session data, where weight was collected weekly.|||pounds||Standard Deviation|Mean
1447724|NCT00869557|Secondary|The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL|The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.|Baseline to Weeks 24 and 48|ITT analysis set|||percentage of participants|||Number
1447725|NCT00869557|Secondary|Change From Baseline in CD4 Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to Week 48|ITT analysis set; M = E analysis (all missing data were excluded from the analysis).|||cells/µL||Standard Deviation|Mean
1447726|NCT00869557|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24|Change = Week 24 value minus baseline value|Baseline to Week 24|ITT analysis set. M = E analysis (all missing data were excluded from the analysis).|||cells/µL||Standard Deviation|Mean
1447727|NCT00869557|Secondary|Change From Baseline in HIV-1 RNA (log_10 Copies/mL)|Change = Week 24 or 48 value minus baseline value|Baseline to Weeks 24 and 48|ITT analysis set; The missing = excluded (M = E) analysis method was used in which all missing data were excluded from the analysis.|||log_10 copies/mL||Standard Deviation|Mean
1447728|NCT00869557|Secondary|The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|Week 48|ITT analysis set; M = F analysis (all missing data were considered as failure [HIV-1 RNA ≥ 50 copies/mL]).|||percentage of participants|||Number
1447729|NCT00869557|Primary|The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24|The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.|Week 24|ITT analysis set (all participants who were randomized into the study and received at least 1 dose of study drug). The missing = failure (M = F) analysis method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).|||percentage of participants|||Number
1447730|NCT00869518|Secondary|Recurrent Skin and Skin Structure Infections (SSTI)|recurrent SSTI was by self-report and exam, followed until positive colonization|up to 30 days following completion of treatment|participants were followed until colonization; therefore, no participants were followed past 30 days|||participants|||Number
1447731|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|60 days following completion of treatment|Participants were colonized at day 30 (i.e. S. Aureus not eradicated) and were not checked again for follow-up.||||||
1447732|NCT00869518|Secondary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|7 days following completion of treatment||||participants|||Number
1447733|NCT00869518|Primary|Eradication of S. Aureus Colonization|Eradication was measured by performing cultures for S aureus at the nose, throat, and groin|30 days following completion of treatment||||participants|||Number
1447734|NCT00869414|Primary|Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.||6 weeks|This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available||||||
1447736|NCT00869401|Secondary|Objective Response|Objective response to treatment will be determined by a combination of the results of neurological exam and the MRI and/or CT measurement of the tumor at each evaluation as is used for all NCCTG neuro-oncology trials. The proportion of patients in each response category will be summarized. Only phase II patients were evaluated for response.|Up to 5 years post treatment|Participants that have at least one disease evaluation for assessing best response to treatment.|||Proportion of participants|||Number
1447737|NCT00869401|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Only Phase II patients were evaluated for Progression-free survival|Up to 5 years post treatment|All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable|||Months||95% Confidence Interval|Median
1447738|NCT00869401|Primary|The Number of Dose Limiting Toxicities(DLT) in Order to Determine Maximum Tolerable Dose(MTD) of Dasatinib Combined With Radiation and Temozolomide in This Patient Population.|Doselimiting toxicity will be defined as: Adverse event at least possibly related to the study medication. All by CTCAE v3.0 criteria: Greater than or equal to grade 3: diarrhea or skin rash or desquamation or (other) clinically relevant non-hematological adverse event or non-hematologic adverse event at least possibly due to drug therapy. Or greater than or equal to grade 4: neutropenia or leukopenia or thrombocytopenia or radiation dermatitis or hematologic adverse event OR failure to administer greater than 75% of dasatinib TMZ or interruption of RT for more than 5 days due to adverse events.OR severe acute central nervous system deterioration attributable to TMZ, RT and or dasatinib which cannot be controlled with corticosteroid administration. The MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience DLT with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT.|Every cycle from first dose to end of rest period prior cycle 3|Only Phase I patients were evaluated for maximum tolerable dose.|||participants with Dose Limiting Toxicits|||Number
1447739|NCT00869401|Primary|Overall Survival|Overall survival (OS) is the primary endpoint and is defined as the time from study registration to time of death due to any cause. All patients who meet the eligibility criteria, have signed a consent form, and have received at least one dose of the regimens will be considered evaluable. Patients who are lost to follow-up will be censored at the date of their last follow-up. Patients still alive at the time of analysis will be censored. Only Phase II was evaluated for survival|Up to 5 years post treatment||||Months||95% Confidence Interval|Median
1447740|NCT00869375|Primary|Incidence of Bleeding Complications||24 hours after the procedure||||participants|||Number
1447741|NCT00869375|Primary|Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence||24 hours after the procedure||||participants|||Number
1447742|NCT00869362|Secondary|Average Intervention Effect Over 12 Months After Hospital Discharge||12 months from discharge||||HbA1c, %||Standard Error|Mean
1447743|NCT00869362|Primary|Hemoglobin A1c|Change in glycemic control measured by HbA1c change baseline to 6 months|6 months from discharge||||HbA1c, %||Standard Deviation|Mean
1447744|NCT00869349|Secondary|Self-Compassion|Change in the Neff Self Compassion scale from baseline to 21-months. This is a 26-item scale. The total self-compassion score ranges from 0 (no self-compassion) - 30 (high self-compassion). Reference: Neff, K.D. (2003). Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.|||units on a scale||Standard Deviation|Mean
1447745|NCT00869349|Secondary|Depression|"Change in the Beck Depression Scale from baseline to 21-months. The BDI-II (Reference: BDI- II Manual by Aaron T. Beck, Robert A. Steer, and Gregory K. Brown) is a 21-item scale for measuring negative attitudes about the future. Add up each of the items marked in the direction keyed for hopelessness to get a total score.~Each of 21 items is summed to give single score for BDI-II.~There is 4-point scale ranging from 0 - 3. On 2 items (16, 18)~There are 7 options to indicate either increase or decrease of appetite and sleep. These are still scored 0 - 3 - answers are 0,1a,1b,2a,2b,3a,3b.~Cut score guidelines for the BDI-II are given with recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the BDI-II.~0 - 13 minimal 14 - 19 mild 20 - 28 moderate 29 – 63 severe"|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.|||units on a scale||Standard Deviation|Mean
1447746|NCT00869349|Primary|RADAI Disease Activity Score|"Change in self-assessed disease activity from baseline to 21-months. Total RADAI score is 0-10 with 0 indicating no/low self-assessed disease activity and 10 indicating high self-assessed disease activity.~Reference: Stucki G, Liang M, Stucki S, Bruhlmann P, Michel BA. A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiological research. Psychometric properties and correlation with parameters of disease activity. Arthritis Rheum. 38;795-98,1995"|21 months|Data reported on per-protocol analysis. Sensitivity analysis was performed to evaluate robustness of analyses.|||units on a scale||Standard Deviation|Mean
1447747|NCT00869323|Secondary|Overall Survival||at 2 years||||participants|||Number
1447748|NCT00869323|Secondary|Relapse-free Survival||at 2 years||||participants|||Number
1447749|NCT00869323|Secondary|Time to Treatment Failure||Day 1 to Time of Disease Progression|Two participants had a complete response at the time they completed the study and were not included in this outcome measure.|||months|||Number
1447750|NCT00869323|Secondary|Remission Duration Among Patients Who Respond to Treatment||Day 1 to 8 Months Post Treatment|Both of the participants who responded to treatment were in remission at last contact or death.|||months||Full Range|Median
1447751|NCT00869323|Primary|Number of Patients With Overall (Complete and Partial) Response Rates||Day 1 to 2 Years Post Treatment||||participants|||Number
1447752|NCT00869258|Primary|Conversion Rate of Inoperable to Operable|Data was not analyzed because original PI left institution before data analysis was completed.|10 weeks|||||||
1447753|NCT00869167|Primary|Insomnia Severity Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.~PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|5 weeks|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||units on a scale||Standard Deviation|Mean
1447755|NCT00869167|Secondary|Daytime Performance (Digit Symbol Substitution Test)|"DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters.~DSST score can range from 0-125, with 125 being the most number correct during the allotted time period."|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||Number correct||Standard Deviation|Mean
1447756|NCT00869167|Secondary|Daytime Sleepiness (Epworth Sleepiness Scale)|Score of 0-24, with 24 being the most sleepy|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||units on a scale||Standard Deviation|Mean
1447757|NCT00869167|Primary|Pittsburgh Sleep Quality Index|"The change in ISI and PSQI from baseline to end of study will be compared between the two groups.~PSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms"|baseline and post-treatment (at end of 5 weeks)|The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.|||units on a scale||Standard Deviation|Mean
1447758|NCT00869141|Primary|Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase|intraocular pressure of eyes with hypertensive phase versus without hypertensive phase|1 year after surgery|Please note that these two groups were different from those groups in previous comparison. The patients that developed hypertensive phase were compared to those that did not developed hypertensive phase, so the number of patients in these two groups and the mean pressure at 1 year +/-standard deviation results were different.|||mmHg in 1 year postop||Standard Deviation|Mean
1447759|NCT00869141|Primary|Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma|intraocular pressure comparison between groups after the Ahmed valve implantation|3 weeks after surgery|Eye pressure at postop 3-week is reported|||mmHg at postop 3-week||Standard Deviation|Mean
1447760|NCT00869141|Primary|Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma|Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week|within 6 months after surgery||||participants|||Number
1447761|NCT00869128|Primary|Sleep Efficiency|Sleep efficiency is the percentage of time patients were asleep while in bed as scored by the actigraphic sleep algorithm assessed in the 3 consecutive last nights of each period|3 weeks|ITT|||Percentage of time asleep||Standard Deviation|Mean
1447762|NCT00869089|Primary|Improvement in Prurigo Nodularis||24 weeks|Subjects who completed the study were analyzed.|||participants|||Number
1447763|NCT00869050|Primary|Number of Participants With Complete Response (CR)|CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.|12 months|28/38 analyzed.|||participants|||Number
1447764|NCT00869050|Primary|Number of Participants With Partial Response (PR)|PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.|12 months|28/38 analyzed.|||participants|||Number
1447765|NCT00868998|Secondary|Toxicity|Data was not analyzed due to poor accrual.|Prior to day 4 and on day 12|||||||
1447766|NCT00868998|Primary|Response Rate|Data was not analyzed due to poor accrual.|10 weeks|||||||
1447767|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Clinical Global Impressions Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"This CGI-BP-S is a clinician-rated assessment of the subjects current severity of depression and ranges from 1=Normal, not ill to 7=Very severly ill. Higher scores are associated with greater severity."|24 weeks||||units on a scale||Standard Deviation|Mean
1447768|NCT00868959|Secondary|Change From Open-label Extension Baseline to Week 24 (Month 6/LOCF Endpoint) in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a clinician-rated assessment of the subject’s level of depression. Ten items are rated on a Likert scale, from 0=”Normal” to 6=”Most Severe”. The MADRS total score is calculated as the sum of ten items: reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity.|24 weeks||||units on a scale||Standard Deviation|Mean
1447769|NCT00868959|Primary|Number of Participants With Serious and Non-serious Treatment-emergent Adverse Events Who Have Completed 24 Weeks of Extension Study Treatment|Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)|24 weeks||||participants|||Number
1447770|NCT00868790|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 16 Visit (up to 16 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.|||Participants|||Number
1447790|NCT00868608|Secondary|Kaplan-Meier Estimate of the OS in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Months||95% Confidence Interval|Median
1447771|NCT00868790|Primary|Number of Participants With At Least One Adverse Event (AE) in the Treatment or Post-Treatment Periods|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR’s product, is also an AE.|From first dose of study treatment (Week 0 Visit) to Week 18 Post-study Visit (up to 18 weeks).|All randomized participants who took ≥1 dose of study treatment (N=118). Because this was a cross-over study, participants were counted in more than one treatment group. AEs were reported by the treatment that participants were receiving at the time of the event. Not all participants received all treatments.|||Participants|||Number
1447772|NCT00868790|Secondary|Percentage Change From Baseline (BL) After 4-Week Treatment in Low-Density Lipoprotein C (LDL-C) Levels|Blood samples were obtained from all participants to measure LDL-C levels at Week 0 (Baseline) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit). For each visit, LDL-C was measured over 2 days. The average of duplicate measurements (when available) was used in the analysis.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, and Week 16 Visit|All randomized participants who took at least 1 dose of study treatment and had a valid reading at timepoint.|||percentage change from BL||90% Confidence Interval|Least Squares Mean
1447773|NCT00868790|Secondary|Change From BL After 4-Week Treatment in 2-hour Post-Meal Glucose (PMG) Levels|Two-hour PMG was analyzed in both non-domiciled and domiciled participants. Non-domiciled participants completed a 3-point meal tolerance test (MTT) at Week 0 (Baseline) and Week 4 Visits of Treatment Period 1. Participants completed 12-hr fasting prior to the Week 0 (Baseline) and Week-4 clinic visits. Fasting blood samples were obtained at the beginning of these clinic visits, after which participants consumed a standardized meal (1 nutrition bar and 1 can of nutrition drink), and then completed the MTT, in which plasma glucose was measured at 30 min and 120 min (2 hr) post-meal. The 2-hr PMG data also include data from domiciled participants, based on 2-hr post-morning meal glucose levels in the 24-hr blood glucose sample at the Week 4 and Week 8 Visits. The 2-hour PMG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in 2-hour PMG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 visit|All randomized participants receiving ≥1 dose of therapy and having MTT measurement either at Week 0 (BL) or end of Treatment Period 1. N=number of participants included in the Longitudinal Data Analysis (LDA) model|||mg/dL||Standard Error|Least Squares Mean
1447774|NCT00868790|Secondary|Change From Baseline (BL) After 4-Week Treatment in Fasting Plasma Glucose (FPG)|Fasting blood samples were obtained during study site visits at Baseline (Week 0 Visit) and Week 4 of each treatment period (Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit). Participants were counseled to fast (no food or drink except water and non-study medications, as directed) for at least 12 hours prior to all study visits. FPG was analyzed using an LDA model, and change from baseline (Week 0) after 4-week treatment in FPG was reported.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit, Week 12 Visit, Week 16 Visit|All randomized participants receiving ≥1 dose of therapy and having FPG measurement either at BL or end of Treatment Period. Number of Participants Analyzed=number of participants included in the LDA model.|||mg/dL||Standard Error|Least Squares Mean
1447775|NCT00868790|Primary|Change From Baseline (BL) After 4-Week Treatment in Weighted Mean Glucose (WMG)|The primary efficacy outcome in this study was the assessment of 24-hour weighted mean glucose (WMG) levels for domiciled participants after 4-week treatment (Periods 1 and 2 only). At selected study sites, a subset of participants domiciled (stayed) overnight and underwent 24-hour blood sampling at the Week 0 Visit (Baseline), Week 4 Visit (end of Period 1), and Week 8 Visit (end of Period 2). Domiciled participants were not expected to follow a weight-maintaining diet while receiving standard meals from a dietician or licensed healthcare professional. WMG was calculated as the weighted average value of the glucose from the 24-hour blood sample (for Baseline, Week 4, and Week 8) and analyzed using a Longitudinal Data Analysis (LDA) model. Results were expressed as the change from baseline after 4-week treatment in 24-hour WMG.|Week 0 Visit (Baseline), Week 4 Visit, Week 8 Visit|All randomized domiciled participants receiving ≥1 dose of therapy and having 24-hour WMG measurement either at BL or end of Treatment Period 1 or 2. Number of Participants Analyzed=number of participants included in LDA model. Participants in MK-3577 25 mg BID group did not undergo 24-hour glucose sampling and were not analyzed.|||mg/dL||Standard Error|Least Squares Mean
1447776|NCT00868751|Secondary|Measurement of Sustained Clinical Response to Tocilizumab, Including Active Joint Count, Joints With Limited Range of Motion, and Absence of Fever or Rash.|To assess sustained clinical response to tocilizumab, including active joint count, joints with limited range of motion, and absence of fever|At weeks 8, 12, 16 of treatment, and every 8 weeks thereafter|No data are available because data were not collected||||||
1447777|NCT00868751|Secondary|Measurement of Laboratory Parameters of Active Disease, Specifically C-reactive Protein, Hemoglobin, Platelets, White Blood Cell Count, Ferritin, Immunoglobulins.|To assess normalization of laboratory parameters of active disease, specifically C-reactive protein, hemoglobin, platelets, white blood cell|At weeks 8, 12, and 16 of treatment, and every 8-12 weeks thereafter|No data are available because data were not collected||||||
1447778|NCT00868751|Primary|Number of Participants With at Least One Adverse Event|To evaluate the safety of tocilizumab administration in this subject|Ongoing, throughout 24 month study period|No data are available because data were not collected|||Participants|||Count of Participants
1447779|NCT00868751|Primary|Efficacy of Tocilizumab as Defined by Reduction of Oral Prednisone Dose by at Least 20%, or to Less Than 0.5mg/kg/Day, Whichever is of Lesser Daily Dose, While Maintaining an ACR JIA30 Response||At weeks 12 and 16 of treatment versus week 0 (pretreatment)|No data are available because data were not collected||||||
1447780|NCT00868751|Primary|Efficacy of Tocilizumab as Defined by Presence of an Equal to or Greater Than 30% Improvement in JIA Core Set (i.e. ACR JIA30 Response)||At week 12 of treatment versus week 0 (pretreatment)|No data are available because data were not collected||||||
1447781|NCT00868712|Secondary|International Normalized Ratio|The International Normalized Ratio (INR) is a standardized lab value that measures the intensity of anticogulation using warfarin. It is used to monitor patients taking warfarin.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.||||ratio||Standard Deviation|Mean
1447782|NCT00868712|Primary|Coronary Calcification (Presence and Degree as Measured by Agatston Score) Attributed to Duration of Warfarin Use in Months After Controlling for Standard Cardiovascular Risk Factors to Include the Framingham Risk Score|The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; >1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.|EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.|After interim analysis following n=70 showed no effect, further enrollment was halted.|||Agatston Score||Standard Deviation|Mean
1447783|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|"Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.~The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items."|Baseline to Week 6|Intent-to-treat population is analyzed. Number of participants in table is not consistent with intent-to-treat population because: if one or more items are missing at a study visit, as can occur when a subject opts out of the work/school item because it does not apply, the authors of the scale recommend setting the total score to missing|||units on a scale||Standard Error|Least Squares Mean
1447784|NCT00868699|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|"Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.~The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome."|Baseline to Week 6|Intent-to-treat population is analyzed.|||units on a scale||Standard Error|Least Squares Mean
1447785|NCT00868699|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items."|Baseline to Week 6|Intent-to-treat population is analyzed.|||units on a scale||Standard Error|Least Squares Mean
1447786|NCT00868608|Secondary|Percentage of Participants With QTc Interval Corrected Using Fridericia’s Formula (QTcF) by Category (Safety Population)|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR). Maximum QTcF was categorized as less than or equal to (≤) 450 msec, >450 msec to ≤480 msec, >480 msec to ≤500 msec and >500 msec. Participants are reported only once under the maximum QTcF interval observed at any of the time-points. Maximum increase from baseline was categorized as <30 msec, ≥30 to <60 msec (borderline) and ≥60 msec (prolonged) were summarized.|Screening; Cycle 1: pre-dose & 1 hour; Cycles 3 and 4: pre-dose, 1, 3, 48, and 168 hours; Cycle 6: pre-dose; end of treatment: 28 to 56 days post-last dose.|Safety Population|||Percentage of Participants|||Number
1447787|NCT00868608|Secondary|Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)|Includes all TEAEs: any event that emerged after the first dose of the study treatment during the treatment period that was absent before administration of any study treatment, or worsened during the treatment period relative to the pre-treatment state.|Protocol reporting period: from informed consent to at least 28 days after the last dose.|Safety Population - includes all participants who received at least 1 dose of study medication. This population only excluded participants who never received any study medication.|||Percentage of Participants|||Number
1447788|NCT00868608|Secondary|Median Induced Change From Baseline of QT Study Specific Correction (QTcS) by Cycle Based on Median Maximum Calicheamicin Concentration (Cmax)|Triplicate 12-lead electrocardiogram (ECG) measurements were performed approximately 2 minutes apart. ECG assessments were pre-specified in the protocol to be time-matched with selected pharmacokinetic (PK) samples in order to conduct a concentration-QTc analysis. A study-specific QT correction factor was estimated using the un-averaged triplicate data and was used to calculate the study-specific corrected QT (QTcS). QTcS interval versus serum concentrations were modeled using a population analysis approach to identify potential effects of total calicheamicin exposure. Results for drug effects were based on the median Cmax for total calicheamicin across all participants: median Cmax was 61.3 ng/mL|Cycle 1: pre-dose, 1 hour; Cycle 3 & 4: pre-dose, 1, 3, 48, 168 hours; Cycle 6 (if applicable): pre-dose; end of treatment: during clinic visit|There were 80 participants in the analysis dataset, but time-matched PK-ECG data only existed for 73 participants (35 female).|||Milliseconds (msec)||90% Confidence Interval|Median
1447789|NCT00868608|Secondary|Kaplan-Meier Esitmates of the Probability of Survival at 6, 12 and 24 Months in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|6, 12 and 24 months|ITT population (participants with NHL type defined as follicular).|||Probability||95% Confidence Interval|Number
1448185|NCT00865189|Secondary|Overall Survival|The overall survival was defined as the time from the first treatment intake to death from any cause.|From the first treatment administration to the date of death (up to approximately 6 years)|ITT population|||months||95% Confidence Interval|Median
1447792|NCT00868608|Secondary|Kaplan-Meier Estimate of the Overall Survival (OS) in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. OS was defined as the time from enrollment to death from any cause. For participants without death, censorship occurred at the date of last contact.|Any time up to 2 years after enrollment. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.|||Months||95% Confidence Interval|Median
1447793|NCT00868608|Secondary|Kaplan-Meier Estimate of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|ITT population (participants with NHL type defined as follicular).|||Percenr probability||95% Confidence Interval|Number
1447794|NCT00868608|Secondary|Kaplan-Meier Estimate of the PFS in Participants With Follicular NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to progression of disease or death from any cause. Events were defined as death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Months||95% Confidence Interval|Median
1447795|NCT00868608|Secondary|Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12 and 24 Months in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|ITT population.|||Percent Probability||95% Confidence Interval|Number
1447796|NCT00868608|Secondary|Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in Participants With Indolent NHL|Kaplan-Meier: a rule for calculating an estimate of survival. PFS was defined as time from enrollment to death from any cause without progression, progression during and after treatment, and initiation of all new anti-cancer treatments for the lymphoma. For participants with no event, censorship occurred at the date of last valid disease assessment. PD was defined in accordance with the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.|||Months||95% Confidence Interval|Median
1447797|NCT00868608|Secondary|Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Follicular NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|Participants with Follicular NHL who responded.|||Probability||95% Confidence Interval|Number
1447798|NCT00868608|Secondary|Duration of Response in Participants With Follicular NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Participants with Follicular NHL who responded.|||Months||95% Confidence Interval|Median
1447799|NCT00868608|Secondary|Probability of Maintaining a Response at 6, 12 and 24 Months in Participants With Indolent NHL|Duration of response was measured from the first date of response until the first date that the objective PD or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|6, 12 and 24 months|Participants with Indolent NHL who responded.|||Probability||95% Confidence Interval|Number
1447800|NCT00868608|Secondary|Duration of Response in Participants With Indolent NHL|Duration of response was measured from the first date of response until the first date that the objective progression of disease (PD) or symptomatic deterioration or initiation of new anticancer therapy for the lymphoma or death from any cause is documented. Participants without an event were censored at the date of the last valid tumor assessment. A valid tumor assessment visit was defined as the tumor assessment visit with overall response of CR, PR, stable disease (SD), or PD, but not ‘Not Done’ or ‘Unknown’. PD was defined according to the International Response Criteria for NHL: 1) New lesion or increase by ≥50% of previously involved sites from nadir, 2) New lesion(s) >1.5 cm (any axis); ≥50% increase in SPD of >1 node; or ≥50% increase in longest diameter of previously identified node >1 cm in short axis, 3) >50% increase from nadir in the SPD of any previous lesions (splenic or hepatic) and 4) New or recurrent involvement in bone marrow.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Participants with Indolent NHL who responded.|||Months||95% Confidence Interval|Median
1447801|NCT00868608|Secondary|Percentage of Participants With Follicular NHL Achieving a CR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Percentage of Participants||95% Confidence Interval|Number
1447802|NCT00868608|Secondary|Percentage of Participants With Indolent NHL Achieving a CR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population.|||Percentage of Participants||95% Confidence Interval|Number
1447803|NCT00868608|Secondary|Percentage of Participants With Follicular NHL Achieving CR or PR According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or greatest transverse diameter (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|ITT population (participants with NHL type defined as follicular).|||Percentage of Participants||95% Confidence Interval|Number
1447804|NCT00868608|Primary|Percentage of Participants With Indolent NHL Achieving CR or Partial Response (PR) According to International Response Criteria for NHL|CR was defined as complete disappearance of all target lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 cm in their greatest transverse diameter [GTD] for nodes more than [>]1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by greater than or equal to [≥]50% in the SPD or GTD (for single nodules). With exception of splenic and hepatic nodules, involvement of other organs was usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.|Assessed for up to 2 years, including planned assessments every 8 to 12 weeks from first dose of study drug. Follow-up period may have been extended beyond 2 years due to dosing delays and allowed study visit windows.|Intent to treat (ITT) population: all participants who were enrolled into the study.|||Percentage of Participants||95% Confidence Interval|Number
1447805|NCT00868530|Other Pre-specified|Average Dose of Xyntha Infusions Required Per Hemorrhage|The average dose of Xyntha per hemorrhagic event was calculated as total dose of Xyntha throughout the study (in IU) divided by total number of hemorrhage incidence.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Dose/Bleed (IU)||Standard Deviation|Mean
1447806|NCT00868530|Other Pre-specified|Frequency of Xyntha Infusions Required Per Hemorrhage|The mean frequency of Xyntha infusions per hemorrhage was calculated as total number of injections throughout the study divided by total number of hemorrhagic events.|Day 1 to Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Infusions||Standard Deviation|Mean
1447807|NCT00868530|Secondary|Number of Participants With Thrombosis||Baseline up to 6 months|The SS consisted of all participants who had taken at least 1 dose of investigational drug.|||Participants|||Number
1447808|NCT00868530|Secondary|Number of Participants With Thrombosis Allergic-Type Reactions||Baseline up to 6 months|The Safety Set (SS) consisted of all participants who had taken at least 1 dose of investigational drug.|||Participants|||Number
1447809|NCT00868530|Secondary|Number of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE, defined for on-demand treatment as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|24 hours after each of 2 successive infusion, up to 6 months|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Participants|||Number
1447810|NCT00868530|Secondary|FVIII Recovery : Change From Baseline in FVIII Concentration|FVIII recovery was assessed by evaluating the change in FVIII concentration at 6 months compared to baseline.|Day 1 and Month 6 or Early Termination Visit|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. Participants with missing data were not included.|||IU/dL per IU/kg||Standard Deviation|Mean
1447811|NCT00868530|Primary|Number of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and <= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Day 1 and Month 6 or Early Termination Visit|The Safety Set (SS) consisted of all participants who had taken at least 1 dose of investigational drug.|||Participants|||Number
1447812|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|24 hours post infusion|The FAS consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
1447813|NCT00868530|Primary|Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion|The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).|8 hours post infusion|The Full Analysis Set (FAS) consisted of all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
1447814|NCT00868517|Secondary|Fragmented Sleep Patterns-Sleep Efficiency|Disruptive sleep patterns that were analyzed by looking at Sleep Efficiency(SE). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months||||percentage of TST to time in bed||95% Confidence Interval|Mean
1447815|NCT00868517|Secondary|Number of Participants That Were Satisfied Based on Veteran Satisfaction Scores for True Group Acupuncture vs. Sham Group Acupuncture||t= 2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.|||participants|||Number
1447816|NCT00868517|Secondary|Attrition Rates|Examined attendance rates in attending group sessions to examine attrition rates.|t=2 months|For this measure, participants in wait list control group not analyzed as did not participate in group sessions.|||% of sessions attended||Standard Deviation|Mean
1447817|NCT00868517|Secondary|Hypnotic Medication Use|Amount of sleep medication taken by study participants. Measured by looking at demographic questionnaire results, chart reviews and Morin sleep diary (MSD).|t=2 months||||participants|||Number
1447818|NCT00868517|Secondary|Fragmented Sleep Patterns-Total Sleep Time, Sleep Latency, and Naps|Disruptive sleep patterns were analyzed by looking at Total Sleep Time (TST), Sleep Latency (SL), and Naps (short episodes of sleep at times other than bedtime). Morin sleep diaries (MSD) and wrist actigraphs (WA) were the study instruments used to collect this data.|t=2 months||||minutes||95% Confidence Interval|Mean
1447819|NCT00868517|Primary|Perceived Sleep Quality|"Perceived sleep quality: subjective assessment of how restorative and undisturbed sleep has been. Measured by Insomnia Severity Index (ISI) and Morin sleep diary refreshness and soundness ratings.~ISI: 7-item, self-report questionnaire based on DSM-IV criteria for insomnia. ISI scores range from 0 to 28 with higher scores reflecting greater insomnia. Total scores were reported, and an ISI cutoff total score of > 8 is indicative of probable insomnia.~The Morin Sleep Diary refreshness and soundness ratings are based on a 5-point Likert scale with scores ranging from 1 to 5. Scores for these two questions were reported and higher scores indicate higher perceived sleep quality."|t=2 months||||units on a scale||95% Confidence Interval|Mean
1447820|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score|STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baselin Week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Deviation|Least Squares Mean
1447821|NCT00868452|Secondary|Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)|CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline Week 6|Full analyis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
1447822|NCT00868452|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)|MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.|Baseline, Week 6|Full analysis set (intent-to-treat population)|||units on a scale||Standard Error|Least Squares Mean
1447823|NCT00868439|Secondary|Time to First Elevated Serum K+ > 5.5 mEq/L.||28 Days||||days||95% Confidence Interval|Median
1447824|NCT00868439|Secondary|Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L||Baseline and Day 28|Analysis was determined using LOCF.|||percentage of participants|||Number
1447825|NCT00868439|Secondary|Proportion of Participants Whose Spironolactone Dose Was Increased.||28 Days||||percentage of participants|||Number
1447826|NCT00868439|Secondary|Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).|Analysis based on local laboratory data.|28 Days||||percentage of participants|||Number
1447827|NCT00868439|Secondary|Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.|Analysis based on central laboratory data.|28 Days||||percentage of participants|||Number
1447828|NCT00868439|Primary|Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.||Baseline and Day 28|Analysis was determined using Last Observation Carried Forward (LOCF).|||mEq/L||Standard Error|Least Squares Mean
1447829|NCT00868374|Primary|Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)|The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression.|Week 0 - Week 8||||units on a scale||95% Confidence Interval|Mean
1447830|NCT00868348|Secondary|Pain Intensity During Daily Activity|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|16 weeks after surgery||||mm||Inter-Quartile Range|Median
1447831|NCT00868348|Secondary|Length of Hospital Stay||From the day of surgery until discharge||||days||Inter-Quartile Range|Median
1447832|NCT00868348|Secondary|Home Readiness|Ability to meet discharge criteria (home readiness)|time to fulfilment of discharge criteria||||days||Inter-Quartile Range|Median
1447833|NCT00868348|Secondary|Pain Intensity Scores During Walking|Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)|6-24 hours postoperatively||||mm||Inter-Quartile Range|Median
1447834|NCT00868348|Secondary|Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request||within 48 hours after surgery||||min||Inter-Quartile Range|Median
1447835|NCT00868348|Primary|Morphine Consumption|Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery|48 hours after surgery||||mg||Inter-Quartile Range|Median
1447836|NCT00868309|Secondary|>50,000 Platelets/mm3|Thrombocytopenia during follow up period. Two weeks|Follow up after maintenance dose||||participants|||Number
1447837|NCT00868309|Primary|Detection of Plasma Venom Levels During the Post Acute Treatment Period.||Follow up after Maintenance doses were completed. Two Weeks.||||participants|||Number
1447838|NCT00868296|Primary|Growth Parameters Z-scores|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.|6 weeks|Safety population (all patients with ≥1 dose of study drug) who also had baseline and end of study evaluations. Data point pairs were analyzed. All patients in study 3001B3-335 originated from study 3001B3-331 or -333 and baselines from the original study they were in were used.|||units on scale||Standard Deviation|Mean
1447839|NCT00868296|Primary|Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period|Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive.|6 weeks|Patients who received ≥1 dose of pantoprazole and had laboratory test results. The number of patients (n) tested varied by test, variations shown (low dose, high dose): Carbon dioxide (n=7,26), CPK (n=12,42), Gastrin (n=9,25), Neutrophils (n=12,44), Platelet count (n=12,41), Urine protein albumin (n=10,38), Urine leukocyte esterase (n=10,38).|||patients|||Number
1447840|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447841|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447842|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447843|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447845|NCT00868231|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447846|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447847|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24 hr at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447848|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC0-12) in Liters at Day 1 on Treatment||Day 1|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447849|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24 hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447850|NCT00868231|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 12-24hr at Day 15 on Treatment||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447851|NCT00868231|Primary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment.||Day 15|Intention-to-treat (ITT) population; patients were included who took at least one dose of Investigational Medicinal Product and had at least a baseline and one post-dose value of FEV1|||Liters||Standard Error|Least Squares Mean
1447852|NCT00868218|Secondary|Immunogenicity of a Non-adjuvanted and 3rd Generation ISCOM™ Adjuvanted Virosomal H5N1 Influenza Vaccine|Number of participants with haemagglutination inhibition tigers >= 32 at the long term time point (1 year post vaccination).|one year||||participants|||Number
1447853|NCT00868218|Primary|Adverse Events||42 days||||participants|||Number
1447854|NCT00868218|Primary|Solicted Adverse Events|The primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered virosomal H5N1 influenza vaccine with or without 3rd generation ISCOM™ adjuvant.|three months||||participants|||Number
1447855|NCT00868192|Post-Hoc|CA-125 Response|A CA-125 response was defined as at least a 50% reduction in CA-125 levels from a pretreatment sample following guidelines described by the Gynecological Cancer Intergroup.|6 months|7 participants were not evauable by CA-125 criteria.|||participants|||Number
1447856|NCT00868192|Post-Hoc|Overall Response Rate|"Overall response rate = complete response + partial response~Complete response = disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial response = at least a 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be non unequivocal progression of non-target lesions and no new lesions."|6 months||||percentage of participants||95% Confidence Interval|Number
1447857|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
1447858|NCT00868192|Post-Hoc|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
1447859|NCT00868192|Post-Hoc|Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|12 months||||percentage of participants||95% Confidence Interval|Number
1447860|NCT00868192|Secondary|Association Between Levels of Thymidylate Synthase, Dihydrofolate Reductase, and Glycinamide Ribonucleotide Formyl Transferase and Ovarian Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.||||||
1447861|NCT00868192|Secondary|Gene Expression as Assessed by Illumina cDNA Mediated Annealing, Selection, Extension and Ligation (DASL) Microarray From Paraffin-embedded Tumor Specimens With Response to Pemetrexed and Bevacizumab||6 months|This outcome was not analyzed. Columbia University was to participate in this study but did not. They were to perform the correlative studies.||||||
1447862|NCT00868192|Secondary|Frequency of Clinical Response|As measured by RECIST criteria|6 months||||participants|||Number
1447863|NCT00868192|Secondary|Toxicity Associated With Bevacizumab and Pemetrexed|Detailed serious adverse events and other adverse events are shown in the adverse event module of the results.|6 months||||percentage of participants|||Number
1447864|NCT00868192|Secondary|Distribution of Overall Survival (OS)|OS = observed length of time from entry into the study to death or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
1447865|NCT00868192|Secondary|Distribution of Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|Median follow-up was 25.7 months (range 3.0-47.2 months)||||months||95% Confidence Interval|Median
1447866|NCT00868192|Primary|Progression-free Survival (PFS)|PFS = Period from study entry until disease progression, death, or date of last contact|6 months||||percentage of participants||95% Confidence Interval|Number
1447867|NCT00868140|Secondary|Matsuda Index|Whole body insulin sensitivity as determined by the Matsuda Index|6 months||||units on a scale||Standard Error|Mean
1447870|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT following 6 months of treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|6 months||||% bioactivity at time 0 of OGTT||Standard Error|Mean
1447871|NCT00868140|Secondary|Matsuda Index|"Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula:~10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load.~Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity. A value of 2.5 or less is indicative of insulin resistance."|Baseline||||units on a scale||Standard Error|Mean
1447872|NCT00868140|Primary|AUC DCI-IPG (%/Min)|Change in the Area Under the Curve DCI-IPG measurements in blood samples taken at 15 minute intervals during the 2 hour OGTT before treatment with pioglitazone or placebo. Values reported as a percentage of bioactivity measured at time 0. Negative values indicate a decrease relative to the time 0 measurement.|Baseline||||% bioactivity at time 0 of OGTT||Standard Error|Mean
1447873|NCT00868101|Secondary|Troponin I|Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.|24 hours||||pg/mL||Standard Deviation|Mean
1447874|NCT00868101|Primary|Interleucine 8|Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method|24 hours||||pg/mL||Standard Deviation|Mean
1447875|NCT00868101|Primary|IkB-alpha Expression|"Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in arbitraries units, that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value."|24 hours||||units on a scale||Standard Deviation|Mean
1447876|NCT00868101|Secondary|NT-proBNP|Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.|24 hours||||pg/mL||Standard Deviation|Mean
1447877|NCT00867659|Primary|Ovarian Volumes as a Predictor of OHSS Severity|ultrasound measurements of both ovaries|30 days||||cc||Full Range|Mean
1447878|NCT00867659|Primary|Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS|evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.|4 weeks||||cc (volume of ascites)||Full Range|Mean
1447879|NCT00867568|Secondary|AUC of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose|||ng*hr/mL||Standard Error|Mean
1447880|NCT00867568|Secondary|Cmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose|||ng/ml||Standard Error|Mean
1447881|NCT00867568|Secondary|Progression Free Survival (PFS) of Participants Using Days From Start of Study Drug Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 4 years|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.|||months||Full Range|Mean
1447882|NCT00867568|Secondary|Number of Patients With an Overall Response Rate (ORR) of PR or CR|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|18 subjects enrolled, one subject censored due to age, 5 subjects not evaluable. Analysis population= 12 patients.|||participants|||Number
1447883|NCT00867568|Secondary|Tmax of TPI 287in Pediatrics Using Pharmacokinetic (PK) Testing.||Cycle 3 day 1 at Pre dose, 0 (end of infusion), 0.25, 0.5, 1, 2, 4, and 6 hours post dose|Six patients at the MTD dose of 125mg/m2/dose|||hour||Full Range|Mean
1447884|NCT00867568|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety, tolerability and maximum tolerated dose (MTD) of TPI 287 as a single agent and collect exploratory data on the safety and tolerability of TPI 287 in combination with temozolomide (TMZ) in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma|2 years||||participants|||Number
1447885|NCT00867529|Secondary|Time to Engraftment|Median time from transplant to engraftment.|18 Months||||Days||Full Range|Median
1447886|NCT00867529|Secondary|Rate of Graft Rejection and Graft Failure|Number of patients experiencing graft rejection and/or graft failure|18 Months||||Participants|||Count of Participants
1447887|NCT00867529|Secondary|Overall Survival and Progression-free Survival|Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant.|At 6 months and then every year thereafter, up to 18 months||||Participants|||Count of Participants
1447900|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized blood pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of patients|||Number
1447927|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 4|Plasma cholestanol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447888|NCT00867529|Secondary|Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0|"Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Through day +100 after transplant||||Participants|||Count of Participants
1447889|NCT00867529|Primary|Disease Relapse Rate|Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.|At 18 months||||Participants|||Count of Participants
1447890|NCT00867503|Primary|Overall Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.||Life of study||||Days||Full Range|Median
1447891|NCT00867503|Secondary|Toxicities of Patients Treated With Bendamustine.|Grade 4 Toxicity|Life of the study||||Partcipants|||Number
1447892|NCT00867503|Primary|Progression Free Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria|life of the study||||Days||Full Range|Median
1447893|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||Percentage of patients|||Number
1447894|NCT00867490|Secondary|Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study|Normalized was defined as a msSBP < 140 mm Hg and/or a msDBP < 90 mm Hg.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||Percentage of patients|||Number
1447895|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Extension Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||BPM (beats per minute)||95% Confidence Interval|Mean
1447896|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Extension Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||mmHg||95% Confidence Interval|Mean
1447897|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||mmHg||95% Confidence Interval|Mean
1447898|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 3 to end of Phase 3|Safety population: All patients who took at least one dose of aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg.|||mmHg||95% Confidence Interval|Mean
1447899|NCT00867490|Secondary|Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study|Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 compared to Baseline in Phase 2 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||Percentage of patients|||Number
1447925|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 12|Plasma cholestanol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447901|NCT00867490|Secondary|Change in Sitting Pulse Rate During the Core Phase of the Study|Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||BPM (beats per minute)||95% Confidence Interval|Mean
1447902|NCT00867490|Secondary|Change in Sitting Pulse Pressure During the Core Phase of the Study|Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
1447903|NCT00867490|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
1447904|NCT00867490|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.|Baseline Phase 2 to end of Phase 2|Intent-to-treat population (ITT): All patients who took at least one dose of aliskiren plus HCTZ who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.|||mmHg||95% Confidence Interval|Mean
1447905|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 35||||units on a scale||Standard Deviation|Mean
1447906|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Hyperactivity/Impulsivity|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Hyperactivity/Impulsivity domain was 0-27. Higher scores are indicative of higher levels of hyperactive/impulsive behaviors.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1447907|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Parent (VADPRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1447908|NCT00867451|Primary|Vanderbilt ADHD Rating Scales - Teacher (VADTRS): Inattention|35-item measure to assess behaviors consistent with ADHD. Nine items reflected the Inattention scale. Range of scores for the Attention Problems domain was 0-27. Higher scores are indicative of higher levels of inattention.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
1447909|NCT00867451|Primary|Percent Total Sleep|Data was gathered via actigraphy. Data on percentage of time individual was immobile during sleep was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly percentage of immobility for that respective week.|Baseline, Week 5||||percentage of immobility||Standard Deviation|Mean
1447910|NCT00867451|Primary|Length of Awake Time|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that respective week.|Baseline; Week 5||||minutes||Standard Deviation|Mean
1447911|NCT00867451|Primary|Sleep Activity (i.e., Average Amount of Time That the Participant Moved During Sleep)|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) of movement during sleep, for that respective week.|Baseline; Week 5||||minutes||Standard Deviation|Mean
1447912|NCT00867451|Primary|Sleep Duration|Data was gathered via actigraphy. Data was gathered on a nightly basis for one week at baseline and at week five. Data presented is the mean nightly value (in minutes) for that week.|Baseline; Week 5||||minutes||Standard Deviation|Mean
1447926|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 8|Plasma cholestanol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447998|NCT00867035|Secondary|Number of Bacteria on Tongue at 1 Week|Total viable count(TVC) in colony forming units(CFU) on anaerobe agar|1 week|ITT|||colony forming units (CFU)||Standard Deviation|Mean
1447913|NCT00867360|Secondary|% Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo|"Time 1 (baseline) = Difference in cortisol level from Day 1 (pre-florinef mean evening cortisol) at Baseline less Day 2 (post-florinef mean evening cortisol) at baseline~Time 2 (post- mife or placebo treatment) = Difference in cortisol level from Day 22 (pre-florinef mean evening cortisol) and Day 23 (post-florinef mean evening cortisol level).~All measurements were the percent change in mean cortisol level from 6 pm to 10 pm. Cortisol levels are expressed as ug/dL~Percent change in cortisol decrease between Time 2 and Time 1 post florinef should be greater with mifepristone than placebo, reflecting enhanced mineralocorticoid receptor activity."|Day 23||||percentage change||Standard Deviation|Mean
1447914|NCT00867360|Primary|Change in Mean Cortisol Level|The reported value is the difference in mean evening cortisol from baseline to Day 9 The mean evening cortisol is calculated from the hourly cortisol value taken from 1800 hrs to 0100 hrs for both time points. The outcome measure is the difference of mean evening cortisol from Day 9 less the mean evening cortrisol from baseline. Negative values indicate a reduction in cortisol levels at Day 9, whereas positive values indicate an increase in cortisol at Day 9. Serum cortisol levels are reported in ug/dL|Day 1 to Day 9 difference|Change in cortisol from Day 1 to Day 9|||ug/dL||Standard Deviation|Mean
1447915|NCT00867360|Primary|Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)|"The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms.~For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms.~The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms."|baseline to day 9||||units on a scale||Standard Deviation|Mean
1447916|NCT00867321|Secondary|Tumor Response at 6 Months|Tumor response (at 6 months) is defined as the number of responses (complete or partial response per Section 11) over the number of eligible patients observed for at least 6 months. Tumor response will be evaluated using simple estimates of proportions.|6 months|No patients were analyzed for this endpoint because data was not collected for it||||||
1447917|NCT00867321|Secondary|Overall Survival|Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up. Kaplan-Meier survival curves will be used to estimate the distribution of OS.|Up to 3 years post treatment|No patients were analyzed for this endpoint because data was not collected for it||||||
1447918|NCT00867321|Primary|Time to Progression (TTP) (Phase II)|Time to progression is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Kaplan-Meier survival curves will be used to estimate the distribution of TTP.|From baseline up to 3 years post treatment|6 of 7 patients have had at least one post-baseline assessment of disease and were used for this endpoint.|||years||95% Confidence Interval|Median
1447919|NCT00867321|Primary|Maximum Tolerated Dose (Phase I)|MTD is defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). If dose level (-1) is not tolerable, but dose (-3) or (-2) is below or at MTD, testing of alternate dose levels (-2a, -3a, -3b) will occur as outlined in the table. The number of dose limiting toxicities will be reported here.|From baseline up to 3 years post treatment|All eligible patients were treated and analyzed.|||Participants|||Count of Participants
1447920|NCT00867217|Primary|Number of Participants With Worsening of Musculoskeletal Symptoms (MS)|Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.|Change from Baseline to 24 Weeks|Subjects available for analysis included those that had completed the entire study; plus three subjects that had dropped out early specifically because of side effects related to musculoskeletal symptoms (one of the endpoints).|||participants|||Number
1447921|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 12|Plasma lathosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447922|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 8|Plasma lathosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447923|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 4|Plasma lathosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447924|NCT00867165|Secondary|Percentage Change From Baseline in Lathosterol at Week 2|Plasma lathosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447999|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Week|Using portable gas chromatograph|1 week|ITT|||parts per billion||Standard Deviation|Mean
1448000|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 4 Hours|Using portable gas chromatograph|4 hours|ITT|||parts per billion||Standard Deviation|Mean
1447928|NCT00867165|Secondary|Percentage Change From Baseline in Cholestanol at Week 2|Plasma cholestanol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447929|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 12|Plasma campesterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447930|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 8|Plasma campesterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447931|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 4|Plasma campesterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447932|NCT00867165|Secondary|Percentage Change From Baseline in Campesterol at Week 2|Plasma campesterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447933|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 12|Plasma sitosterol measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447934|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 8|Plasma sitosterol measured at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447935|NCT00867165|Secondary|Percentage Change From Baseline in Sitosterol at Week 4|Plasma sitosterol measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447936|NCT00867165|Secondary|Percent Change From Baseline in Sitosterol at Week 2|Plasma sitosterol measured at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447937|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 12|Plasma hs-CRP measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447938|NCT00867165|Secondary|Percentage Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 4|Plasma hs-CRP measured at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447939|NCT00867165|Secondary|Percentage Change From Baseline in Apo B:Apo A-I Ratio at Week 12|Serum Apo B:Apo A-I Ratio calculated at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447940|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 12|Serum LDL-C:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447941|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 8|Serum LDL-C:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447942|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 4|Serum LDL-C:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447943|NCT00867165|Secondary|Percentage Change From Baseline in LDL-C:HDL-C Ratio at Week 2|Serum LDL-C:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447944|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 12|Serum TC:HDL-C Ratio calculated at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447945|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 8|Serum TC:HDL-C Ratio calculated at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447946|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 4|Serum TC:HDL-C Ratio calculated at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447947|NCT00867165|Secondary|Percentage Change From Baseline in TC:HDL-C Ratio at Week 2|Serum TC:HDL-C Ratio calculated at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447948|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 12|Serum Apo A-I levels measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447949|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 8|Serum TG levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447950|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 4|Serum TG levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447951|NCT00867165|Secondary|Percentage Change From Baseline in TG at Week 2|Serum TG levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447952|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 8|Serum Non-HDL-C calculated at baseline and after 8 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447953|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 4|Serum Non-HDL-C calculated at baseline and after 4 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447954|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 2|Serum Non-HDL-C calculated at baseline and after 2 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447955|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 8|Serum HDL-C levels measured by photometry after precipitation at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447956|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 4|Serum HDL-C levels measured by photometry after precipitation at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447957|NCT00867165|Secondary|Percentage Change From Baseline HDL-C at Week 2|Serum HDL-C levels measured by photometry after precipitation at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447958|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 8|Serum TC levels measured using enzymatic methods at baseline and after 8 weeks of study drug administration.|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1448001|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 2 Hours|Using portable gas chromatograph|2 hours||||parts per billion||Standard Deviation|Mean
1447959|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 4|Serum TC levels measured using enzymatic methods at baseline and after 4 weeks of study drug administration.|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447960|NCT00867165|Secondary|Percentage Change From Baseline in TC at Week 2|Serum TC levels measured using enzymatic methods at baseline and after 2 weeks of study drug administration.|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447961|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 8|Serum LDL-C levels calculated at baseline and after 8 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 8|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447962|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 4|Serum LDL-C levels calculated at baseline and after 4 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 4|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447963|NCT00867165|Secondary|Percent Change From Baseline in LDL-C at Week 2|Serum LDL-C levels calculated at baseline and after 2 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 2|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447964|NCT00867165|Secondary|Percentage Change From Baseline in Triglycerides (TG) at Week 12|Serum TG levels measured using enzymatic methods at baseline and after 12 weeks of study drug.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage change||95% Confidence Interval|Least Squares Mean
1447965|NCT00867165|Secondary|Percentage Change From Baseline in Non-HDL-C at Week 12|Serum Non-HDL-C calculated at baseline and after 12 weeks of study drug administration. Non-HDL-C values were calculated as follows: Non-HDL-C (mg/dL) = TC – HDL-C.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447966|NCT00867165|Secondary|Percentage Change From Baseline High-density Lipoprotein Cholesterol (HDL-C) at Week 12|Serum HDL-C levels measured by photometry after precipitation at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447967|NCT00867165|Secondary|Percentage Change From Baseline in Apolipoprotein B (Apo B) at Week 12|Serum Apo B measured at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study medication and had a baseline value and at least one valid post-baseline evaluation.|||Percent Change||95% Confidence Interval|Least Squares Mean
1447968|NCT00867165|Secondary|Percentage Change From Baseline in Total Cholesterol (TC) at Week 12|Serum TC levels measured using enzymatic methods at baseline and after 12 weeks of study drug administration.|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study~medication and had a baseline value and at least one valid post-baseline evaluation."|||Percentage Change||95% Confidence Interval|Least Squares Mean
1447969|NCT00867165|Primary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|Serum LDL-C levels calculated at baseline and after 12 weeks of study drug administration. LDL-C were calculated by the method of Friedewald equation, LDL-C = Total Cholesterol (TC) – (High-density lipoprotein cholesterol [HDL-C] + triglyceride [TG]/5).|Baseline and Week 12|"Full Analysis Set (FAS) population defined as all randomized participants who took at least one dose of study~medication and had a baseline value and at least one valid post-baseline evaluation."|||Percent Change||95% Confidence Interval|Least Squares Mean
1447970|NCT00867139|Secondary|Pharmacokinetics (AUC0-last) of TCAD|Only 5 patients had partial pharmacokinetic (PK) data available. Plasma concentration of oseltamivir was measured at several time points in one patient receiving neuraminidase inhibitor monotherapy. Plasma concentration of oseltamivir, amantadine, and ribavirin were measured at several time points in four patients receiving TCAD therapy. Area under the time-concentration curve up to the last measured time point (AUC0-last) was calculated from the plasma concentration-time profiles by non-compartmental analysis.|5 days||||ng*hr/mL||Standard Deviation|Mean
1447971|NCT00867139|Secondary|Number of Deaths||58 days||||participants|||Number
1447972|NCT00867139|Secondary|Number of Participants With Intubations||58 days||||participants|||Number
1447973|NCT00867139|Secondary|Number of Participants With ICU Admissions|The number of participants with ICU admissions was evaluated.|baseline and up to 58 days||||participants|||Number
1447974|NCT00867139|Secondary|Days on Supplemental Oxygen||58 days|One open-labeled TCAD patient withdrew on day 5.|||days||Standard Deviation|Mean
1447975|NCT00867139|Secondary|Duration of Hospitalization||from baseline up to 58 days|One open-labeled patient withdrew the study on day 5|||days||Standard Deviation|Mean
1447976|NCT00867139|Secondary|Frequency of Confirmed Pneumonia||58 days||||participants|||Number
1447977|NCT00867139|Secondary|Duration of Symptoms|"Calculated as the number of days (mean) any persistent symptom lasted per patient as listed below.~overall health, short of breath, chills, cough, diarrhea, ear pain, fatigue, fever, headache, hoarseness, muscle ache, phlegm, runny nose, sinus congestion, sneezing, sore throat, watery eyes, wheezing"|from baseline up to 28 days|one open labeled patient withdrew on day 5.|||days||Standard Deviation|Mean
1447978|NCT00867139|Secondary|Number of Participants With Viral Resistance as a Function of Drug Exposure|Viral resistance was assessed within 28 days after drug administration by detecting resistance-conferring mutation genes and compared to the value at baseline.|28 days|One open-labeled patient withdrew on day 5.|||Number of participants|||Number
1447979|NCT00867139|Secondary|Number of Patients Not Shedding Virus at Day 5 +/-1 and Day 10 +/- 1||10 days|Participants assessed for viral shedding were those with available baseline viral load data.|||participants|||Number
1447980|NCT00867139|Secondary|Number of Participants With Viral Load Decrease as a Function of Time|Viral loads were measured by quantitative Polymerase Chain Reaction (PCR) on day 1, 3, 5, 7, 9, 15, 20 and 28, if applicable.|baseline and 28 days|Three patients could not get viral load at baseline.|||number of participants|||Number
1447981|NCT00867139|Primary|Number of Participants With Adverse Events (AEs), Drug Specific AEs or AEs Resulting in Treatment Interruption|"Abnormal lab data or newly appeared symptoms & signs were considered as AEs.~Examined lab data:~Blood cell count (WBC, differential count, Red Blood Cell (RBC), Hemoglobin, Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets), Chemistry (Cl, bicarbonate (HCO3), K, Na), Renal function test (BUN, Creatinine, Creatinine clearance), Liver function test (AST, Alanine aminotransferase(ALT), T.Bil, gamma-glutamyltransferase)"|30 days after the final dose of study drug||||number of participants with AEs|||Number
1447982|NCT00867113|Secondary|Kaplan-Meier Estimates for Overall Survival (OS) up to 60 Months|Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.|Baseline up to appoximately 60 months||||percentage of participants||95% Confidence Interval|Number
1447983|NCT00867113|Secondary|Overall Survival (OS) at 60 Months|Overall survival was defined as the time from the date of the first dose of study drug to the date of death. Subjects who were alive at the time of discontinuation/completion of the study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment. Full analysis set.|Baseline up to approximately 60 months||||participants|||Number
1447984|NCT00867113|Primary|Kaplan-Meier Estimates for Recurrence-free Survival up to 60 Months|Recurrence-free survival (RFS) assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event). RFS estimates were summarized using the Kaplan-Meier product-limit method (Kaplan 1958). Censoring rules for RFS with the earliest occurring rule used in the analysis: subjects without objective recurrence of disease who were alive at the time of their discontinuation from study were censored at the end of study date or end of treatment visit date if the subject refused to be followed post treatment and subjects recording antineoplastic therapy during the study were censored on the date of the therapy initiated|Baseline up to 60 months||||percentage of patients||95% Confidence Interval|Number
1447985|NCT00867113|Primary|Recurrence-free Survival up to 60 Months|Recurrence-free survival assessment is based on the radiologic evidence and is defined as the time from the date of first dose of imatinib to the date of the first documented disease recurrence or death due to any cause (event).|Baseline up to 60 months||||participants with an event|||Number
1447986|NCT00867087|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment|An AE was any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory/physiologic observations occurring in a participant given a test article or in a clinical study; the event may not necessarily have had a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; cancer. Treatment-emergent AEs were AEs that emerged after the first dose of the study treatment during the treatment period that were absent pre-treatment, or worsened during the treatment period relative to the pre-treatment state. The severity of all AEs was graded by the investigator using the NCI Common Terminology Criteria for AE Version 3.0 (CTCAE v3.0).|Treatment emergent AEs were collected from time of first dose to end of trial visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs were collected from informed consent until end of trial visit (up to 6 months).|Safety population Summary excludes events occurring after start of consolidation treatment.|||Percentage of Participants|||Number
1447987|NCT00867087|Secondary|Percentage of Participants With Any Grade 3/4 Laboratory Abnormality During Therapy|The following parameters were analyzed for serum chemistry; blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. The following parameters were analyzed for hematology; lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE v3.0).|Within 3 days prior each dose of test article, on Day -2, 1, 8, and 15 of Cycles 1 to 3, 2 to 3 weeks after Cycle 3, at the end-of-treatment visit, and every 3 to 6 months during long-term follow-up (up to 2 years).|Safety population|||Percentage of Participants|||Number
1447988|NCT00867087|Secondary|Overall Survival (OS)|OS was the time (in months) from the date of randomization to the date of death, and censored at the date of last contact if no death occurred.|From randomization until the date of death, or the date of last contact if no death occurred (up to 2 years).|ITT population|||Months||95% Confidence Interval|Median
1448002|NCT00867035|Secondary|Concentration of Methyl Mercaptan (MM) in Mouth Air at 1 Hour|Using portable gas chromatograph|1 hour|ITT|||parts per billion (ppb)||Standard Deviation|Mean
1447989|NCT00867087|Secondary|Percentage of Participants With a CR After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|CR: complete disappearance of all detectable clinical & radiographic evidence of disease & disease-related symptoms; lymph nodes & nodal masses regressed to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy); spleen and other organs (if enlarged prior to therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. Response includes confirmed CR and unconfirmed CR.|From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
1447990|NCT00867087|Secondary|Event-Free Survival (EFS) After aSCT|EFS was the time (in months) from the date of aSCT to the earliest date of progression, relapse after CR, death from any cause without progression, initiation of a new treatment for the lymphoma or was censored at the date of the last tumor assessment.|From the completion of aSCT through 2 year long-term follow-up period, including but not limited to planned assessments scheduled every 3 to 6 months.|ITT population. Only participants who underwent aSCT were included in the analysis.|||Months||95% Confidence Interval|Median
1447991|NCT00867087|Secondary|Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT)|Participants underwent high dose chemotherapy and aSCT. In order to proceed to aSCT, participants were required to achieve CR or PR and successful collection of PSBC (≥ 2.0 x 10^6 CD34+ cells/kg collected after 3 cycles).|A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
1447992|NCT00867087|Secondary|Percentage of Participants With Successful G-CSF Mobilization of PBSC|Successful mobilization of PBSC was defined as ≥ 2 x 10^6 CD34+ cells/kg collected after 3 cycles of inotuzumab ozogamicin plus rituximab therapy.|From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
1447993|NCT00867087|Secondary|Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|Successful mobilization of PBSC: ≥ 2 x 10^6 cluster of differentiation (CD) 34+ cells per kilogram (cells/kg) after 3 cycles. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (≤ 1.5 cm in greatest transverse diameter for nodes > 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: ≥ 50% decrease in SPD of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment post treatment were partial responders. Response includes confirmed CR/PR and unconfirmed CR/PR.|From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).|ITT population|||Percentage of Participants||95% Confidence Interval|Number
1447994|NCT00867087|Secondary|Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy|PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.|2 years after the first dose of inotuzumab ozogamicin|ITT population|||Percentage of Participants||95% Confidence Interval|Number
1447995|NCT00867087|Secondary|Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy|PFS; time from date of randomization to earliest date of progression, relapse after CR, death from any cause without progression, start of new treatment for the lymphoma excluding treatments/procedures for consolidation therapy in this protocol, or censored at date of last tumor assessment. Progression: abnormal lymph nodes (long axis > 1.5 cm or long axis 1.1 to 1.5 cm and short axis > 1.0 cm); appearance of any new lesion > 1.5 cm in any axis during or at end of treatment; ≥ 50% increase from nadir in SPD of any previously involved nodes, in a single involved node, or in the size of other lesions; ≥ 50% increase in longest diameter of any single previously identified node > 1.0 cm in short axis.|6 months after the first dose of inotuzumab ozogamicin|ITT population|||Percentage of Participants||95% Confidence Interval|Number
1447996|NCT00867087|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy|Response criteria based on National Cancer Institute (NCI) International Response Criteria for non-Hodgkin’s lymphoma. CR: no detectable clinical & radiographic evidence of disease/disease-related symptoms; lymph nodes/nodal masses regressed to normal size (less than or equal to [≤] 1.5 cm in greatest transverse diameter for nodes greater than [>] 1.5 cm pre-therapy); spleen & other organs (if enlarged pre-therapy) regressed in size & spleen not palpable on physical examination; repeat bone marrow infiltrate clear. PR: > or equal to (≥) 50% decrease in sum of product diameters (SPD) of 6 largest dominant nodes/nodal masses; no increase in size of other nodes, liver, or spleen; splenic & hepatic nodules regressed by ≥ 50% in SPD; involvement of other organs usually assessable & no measurable disease present; no new sites of disease. Participants achieving CR, but with persistent morphologic bone marrow involvement or no bone marrow assessment after treatment were partial responders.|Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)|Intention-to-treat (ITT) population - included all participants enrolled into the study. Response includes confirmed CR/PR and unconfirmed CR/PR.|||Percentage of Participants||95% Confidence Interval|Number
1447997|NCT00867035|Secondary|Percentage of Sulfide-producing Black Colonies Out of Total Viable Count(TVC) on Anaerobe Agar Containing Lead Acetate||1 week|ITT|||percentage black colonies||Standard Deviation|Mean
1448007|NCT00867035|Primary|Percentage of Participants With Rosenberg Score at Indicated Time Points|2 investigators are trained to evaluate smell using the Rosenberg scale which measures foul smelling breath. The Rosenberg scale is validated and is scored 0-5 with 0= no bad breath, 5=worst bad breath. A score of 2 is the threshold at which bad breath is determined.|baseline, 1 hour, 2 hours, 4 hours, 1 week|two judges score breath odor by Rosenberg scale 0 to 5. Score of 2 is threshold for malodor. participants randomly assigned, ITT.|||percentage of participants|||Number
1448008|NCT00867009|Secondary|The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.|From start of treatment until documented best tumor response (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||percentage of participants|||Number
1448009|NCT00867009|Secondary|The Percentage of Participants Still Living at One Year (One Year Survival Rate)|The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.|One year|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||percentage of participants|||Number
1448010|NCT00867009|Secondary|Progression-free Survival (PFS)|PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.|From start of treatment until documented disease progression or death from any cause (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||months||Full Range|Median
1448011|NCT00867009|Primary|Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)|Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.|From start of treatment until documented best response. (up to 18.9 months)|Outcome measure was assessed using the Protocol Qualified (PQ) population.|||percentage of participants|||Number
1448012|NCT00866918|Secondary|Overall Survival (OS)|OS - time from study entry to death.|At 3 years from study entry|Ineligible and inevaluable patients are excluded from analyses of OS.|||Percentage of participants||95% Confidence Interval|Number
1448013|NCT00866918|Secondary|Hematologic, Molecular, and Cytogenetic Remission Rate|Proportion of patients in hematologic, molecular, and cytogenetic remission at end of consolidation, course 3 and 4 are reported. Patients were determined to be in remission by all three criteria.|End of consolidation, course 3; up to 7 months (for Standard Risk) or end of consolidation, course 4; up to 9 months (for High Risk)|Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.|||Proportion of participants|||Number
1448014|NCT00866918|Secondary|Hematologic Remission Rate|Proportion of patients in hematologic remission at end of consolidation, course 1 are reported.|End of consolidation, course 1: up to 5 months|Patients who were ineligible (n=6), inevaluable (n=1), or who electively withdrew during Induction (n=4) were excluded.|||Proportion of participants|||Number
1448015|NCT00866918|Primary|Event-free Survival (EFS)|EFS - time from study entry until failure to achieve complete remission during consolidation, relapse, or death. For further clarification see definitions provided in the protocol.|At 3 years from study entry|Ineligible and inevaluable patients are excluded from analyses of EFS.|||Percentage of participants||95% Confidence Interval|Number
1448016|NCT00866905|Secondary|Disease Free Survival|Defined as the time between Day 1 Cycle 1, and date of first documented recurrence, initiation of additional chemotherapy, or death.|36 Months|||||||
1448017|NCT00866905|Secondary|Overall Survival|Overall survival (OS) determined as the time between day 1 cycle 1 to the date of death from any cause.|36 months|||||||
1448018|NCT00866905|Secondary|Absence of Grade-4 Non-hematologic Toxicity Excluding, Alopecia, Nausea, Vomiting and Bone Pain|Non hematologic treatment-related grade 4 toxicities measured according to RECIST v1.1|3 months||||participants|||Number
1448019|NCT00866905|Primary|Pathologic Complete Response Rate (pCR)|Pathologic complete response (pCR) rate will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following neoadjuvant treatment with six (21-day) cycles of ixabepilone and cyclophosphamide|6 months||||participants|||Number
1448020|NCT00866814|Secondary|Procedure Time|Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.|Day of surgery|All enrolled patients.|||minutes||Standard Deviation|Mean
1448021|NCT00866814|Secondary|Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey|"Mean Quality of Life scores at each study visit for the sensation of mesh, pain, and movement limitation components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure."|Baseline and post-surgery at week 2, month 6 and month 12|All enrolled patients with QOL scores at each visit.|||units on a scale (0-5)||Standard Deviation|Mean
1448022|NCT00866814|Secondary|Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|22 days post surgery through 1 year post surgery|All enrolled patients.|||Complication events|||Number
1448023|NCT00866814|Secondary|Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|Hospital discharge through 21 days post surgery|All enrolled patients.|||Complication events|||Number
1448024|NCT00866814|Secondary|Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital.|In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device.|From the time of surgery to hospital discharge, an average of 1-2 days|All enrolled patients.|||Complication events|||Number
1448025|NCT00866814|Primary|The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.|A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.|1 year post surgery|All enrolled patients.|||participants|||Number
1448026|NCT00866788|Secondary|Terminal Half-Life (t1/2) of Omalizumab|Terminal Half-Life (t1/2) is the time required for the serum concentration of omalizumab to decrease by half in the final stage of its elimination.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.|||days||Standard Deviation|Mean
1448027|NCT00866788|Secondary|Area Under the Concentration-time Curve From Time of Dosing Extrapolated to Infinity (AUC-Inf)|AUCinf is the area under the concentration−time curve from time of dosing extrapolated to infinity. AUCinf was measured in microgram times day per milliliter (µg*day/mL). Only participants having complete profiles and completed the study were included in the analysis.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.|||µg*day/mL||Standard Deviation|Mean
1448028|NCT00866788|Secondary|Time to Maximum Concentration (Tmax) of Omalizumab|Tmax is the time to maximum concentration of omalizumab.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population; Here, number of participants analyzed = participants with available data for this outcome measure.|||days||Standard Deviation|Mean
1448029|NCT00866788|Secondary|Maximum Observed Concentration (Cmax) of Omalizumab|Cmax is the maximum (or peak) concentration of omalizumab in serum.|Pre-dose and 2 hours post-dose on Days 0 and 3 of Week 0, Weeks 1, 2, 3, 4, 8, 12, 16 or early termination (up to Week 16)|Pharmacokinetic−Evaluable Population included all randomized participants who received omalizumab and had pharmacokinetic data available. Here, number of participants analyzed = participants with available data for this outcome measure.|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
1448030|NCT00866788|Secondary|Number of Participants With Immunogenicity|Immunogenicity was measured by detection of anti-therapeutic antibodies (anti-omalizumab antibodies) using a fragment enzyme-linked immunosorbent assay (ELISA).|16 weeks|Safety-Evaluable Population|||participants|||Number
1448031|NCT00866788|Secondary|Number of Patients With Adverse Events by Severity|"The severity (i.e. intensity) of each Adverse Event (AE) was graded according to the following scale: Mild: Symptoms causing no or minimal interference with usual social and functional activities. Moderate: Symptoms causing greater than minimal interference with usual social and functional activities. Severe: Symptoms causing inability to perform usual social and functional activities.~Additional AE data is provided in the AE section below. The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an AE. A “Serious” AE is defined below."|"16 weeks overall (data reported separately for up to 4 weeks and Weeks 5 to 16)"|Safety-Evaluable Population, which included all randomized patients who received any study drug. number (n) equals (=) number of participants analyzed in the specified category.|||participants|||Number
1448032|NCT00866788|Secondary|Change in the Weekly Score for the Amount of Rescue Medication From Baseline to Week 4|Diphenhydramine 25mg was provided and used on an as-needed basis (maximum 3 times/day) as rescue medication. The weekly score for the amount of rescue medication is the sum of the daily scores for the amount of rescue medication used at each day in the week, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||Pills||Standard Deviation|Mean
1448033|NCT00866788|Secondary|Change in the Weekly Score for Sleep Interference From Baseline to Week 4|The extent to which hives or itch interfered with participants’ sleep was recorded once daily in the patient diary using a scale from 0 (no interference) to 3 (substantial interference, waking often). The weekly score of sleep interference was the sum of the daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1448034|NCT00866788|Secondary|Change in the Weekly Score for Number of Hives From Baseline to Week 4|The number of hives was recorded by participants twice daily (morning and evening) using a scale from 0 (no hives) to 3 (more than 12 hives). The weekly score of number of hives was the sum of the average daily scores over the previous 7 days, and ranged from 0 to 21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1448186|NCT00865189|Secondary|Percentage of Participants Who Died||Baseline up to approximately 6 years|ITT population|||percentage of participants|||Number
1448035|NCT00866788|Secondary|Change in the Weekly Pruritus Score From Baseline to Week 4|The pruritus (itch) score was recorded by participants twice daily (morning and evening) based on the severity of itch over the last 12 hours, using a scale from 0 (none) to 3 (severe). The weekly pruritus score was the sum of average daily pruritus scores over the previous 7 days. The range of the weekly score is 0-21.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1448036|NCT00866788|Primary|Change in Urticaria Activity Score 7 (UAS7) From Baseline to Week 4|The UAS is a composite diary−recorded score, which is the sum of the numeric severity intensity ratings (0 = none to 3 = intense) for 1) the number of wheals (hives) and 2) the intensity of the pruritus (itch). The UAS7 is the sum of the daily average UAS (morning and evening values) for 7 days. The maximum UAS7 score is 42.|Baseline (based on the 7 days prior to randomization) and 4 weeks (Days 21-27)|Intent-to-Treat population (all randomized patients). The last observation carried forward value was used if a patient's Week 4 diary data were completely missing. One subject from the omalizumab 600-mg group did not have any post-baseline data and was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
1448037|NCT00866775|Secondary|Standardized Seizure Frequency (SSF) by Period|Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 1 to Week 18, Double-blind: weeks 1 to 18; Baseline: weeks -8 to -1; Titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; Monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60; Baseline: 60; Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Baseline: 118; Titration: 118; AED taper/conversion: 114; Monotherapy: 93|||Number of seizures in 28 days||Standard Deviation|Mean
1448038|NCT00866775|Secondary|Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).||18 Week Double-blind treatment period|ITT population|||Percent of participants|||Number
1448039|NCT00866775|Secondary|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L|18 Week Double-blind treatment period|ITT population|||Percent|||Number
1448040|NCT00866775|Secondary|Percentage of Subjects With Increase of Body Weight >= 7%||18 Week Double-blind treatment period|ITT population|||Percentage of participants|||Number
1448041|NCT00866775|Secondary|Change in Total Score From Baseline in MADRS in Those Subjects With a MADRS Score of ≥14 at Randomization.|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18, Baseline: Day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversation period: 7; Change from baseline to end of monotherapy period: 6 (ESL 1600 mg) Change from baseline to end of AED taper/conversation period: 13; Change from baseline to end of monotherapy period: 13|||units on a scale||Standard Deviation|Mean
1448042|NCT00866775|Secondary|Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).|The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity|Week 0 to Week 18; Baseline: day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period: 41 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 92; Change from baseline to end of monotherapy period: 91|||units on a scale||Standard Deviation|Mean
1448043|NCT00866775|Secondary|Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).|The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.|Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18|the numbers analyzed represent all participants for whom data were available at baseline (ESL 1200 mg)Change from baseline to end of AED taper/conversion period: 39;Change from baseline to end of monotherapy period:36 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 86;Change from baseline to end of monotherapy period: 86|||units on a scale||Standard Deviation|Mean
1448044|NCT00866775|Secondary|Percentage of Subjects Reaching Each of the Exit Events.|The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 1 to Week 18|efficacy population|||percentage of participants|||Number
1448045|NCT00866775|Secondary|Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).|Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.|Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
1448046|NCT00866775|Secondary|Change in Seizure Frequency From Baseline.|The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).|Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18|efficacy population (ESL 1200 mg) Double-blind: 60;Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Titration: 118; AED taper/conversion:114; Monotherapy:93|||percent change||Inter-Quartile Range|Median
1448047|NCT00866775|Secondary|Time on Eslicarbazepine Acetate Monotherapy.|The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.|Week 8 to Week 18|efficacy population|||days||95% Confidence Interval|Median
1448048|NCT00866775|Secondary|Completion Rate During the 10 Weeks of Monotherapy|Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.|Weeks 8 through 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
1448049|NCT00866775|Secondary|Completion Rate|Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.|Week 1 to Week 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
1448050|NCT00866775|Secondary|Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.|Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.|Weeks 15 through 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
1448051|NCT00866775|Secondary|Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.|Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.|Weeks 9 through 18|efficacy population|||percentage of participants||95% Confidence Interval|Number
1448052|NCT00866775|Primary|Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method|Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.|Week 3 to Week 18|efficacy population|||proportion of participants||95% Confidence Interval|Number
1448053|NCT00866723|Primary|Clinical Benefit Response Rate|Clinical benefit response was defined as absence of disease progression at 18 weeks (ie after 6 cycles). Disease progression (PD) could occur per RECIST 1.0 or based on CA-125 levels. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Disease progression based on CA-125 level was doubling of the CA-125 level from baseline. For patients with normal baseline CA-125 (who by definition had MD) the criterion for progression based on CA-125 doubling was doubling of CA-125 from the upper limit of normal (i.e. more than 70).|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.|||proportion of particpants||90% Confidence Interval|Number
1448054|NCT00866723|Primary|Clinical Response Rate|For measurable disease (MD) patients, clinical response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. For non-MD patients, clinical response based on modified Gynecologic Cancer Intergroup (GCIG) criteria was defined as at least a 50% decrease in CA-125 levels.|Disease was evaluated at baseline and every 3 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Patients underwent radiologic assessment (CT or MRI scans) and CA-125 levels were measured.|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
1448055|NCT00866697|Secondary|Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)|Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants with any TSH above 5 MU/L were analyzed.|||participants|||Number
1448086|NCT00866606|Secondary|Percentage of Participants With Red Blood Cell (RBC) Agglutination|RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.|||Percentage of Participants|||Number
1449261|NCT00856726|Primary|Urinary Phosphorus Excretion|Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)|six hours||||percentage of fractional excretion||Standard Deviation|Mean
1448056|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.|||participants|||Number
1448057|NCT00866697|Secondary|Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade|Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population. Only those participants contributing toxicity data were analyzed.|||participants|||Number
1448058|NCT00866697|Secondary|Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population|||participants|||Number
1448059|NCT00866697|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Adverse Event|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgement was to be exercised in deciding whether reporting was appropriate in other situations, such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)|All Treated Population: all randomized participants who received at least one dose of investigational product, based on the actual treatment received if this differed from that to which the participant was randomized|||participants|||Number
1448060|NCT00866697|Secondary|Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25|The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448061|NCT00866697|Secondary|Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25|The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448062|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25|||||||
1448063|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).|Baseline; Week 13; Months 7, 10, 13, 16, and 25|||||||
1448064|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448065|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448066|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448067|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448068|NCT00866697|Secondary|Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448076|NCT00866658|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1448069|NCT00866697|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25|"The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 (poor to excellent). Participants were asked to respond to the following questions using the 7-item Likert scale: How would you rate your overall health during the past week; How would you rate your overall quality of life during the past week? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA)."|Baseline; Week 13; Months 7, 10, 13, 16, and 25|ITT Population. Only those participants available at the specified time points were analyzed.|||scores on a scale||Standard Error|Least Squares Mean
1448070|NCT00866697|Secondary|3-year Progression-free Survival|3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Up to 3 years after randomization|ITT Population|||percentage of participants|||Number
1448071|NCT00866697|Secondary|Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria|Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.|From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)|ITT Population. For participants who did not progress or die, progression-free survival was censored at the time of the last adequate disease assessment.|||months||95% Confidence Interval|Median
1448072|NCT00866697|Secondary|Overall Survival|Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.|From the date of randomization until the date of death due to any cause (median time of follow-up was 24.3 months on pazopanib and 24.2 months on placebo)|ITT Population|||months||95% Confidence Interval|Median
1448073|NCT00866697|Primary|Investigator-assessed Progression-free Survival (PFS)|PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.|From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)|Intent-to-Treat (ITT) Population: all randomized participants|||months||95% Confidence Interval|Median
1448074|NCT00866658|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose less than 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1448075|NCT00866658|Secondary|Percentage of Patients Requiring Rescue Therapy During 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1448199|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Adverse Event|Please refer to Adverse Events section for further details|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
1448077|NCT00866658|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of the study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1448078|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1448079|NCT00866658|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1448080|NCT00866658|Secondary|Change From Screening in Total Insulin Dose at Week 24|Change was calculated by subtracting screening value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Screening, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post baseline insulin dose assessment during on-treatment period.|||units per day||Standard Error|Least Squares Mean
1448081|NCT00866658|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1448082|NCT00866658|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline average 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1448083|NCT00866658|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1448084|NCT00866658|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1448085|NCT00866658|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1448087|NCT00866606|Secondary|Percentage of Participants With Thrombosis|Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.|||Percentage of Participants|||Number
1448088|NCT00866606|Secondary|Percentage of Participants With Allergic-Type Allergic Reactions|Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.|Baseline up to 6 months|SS population included all enrolled participants who had taken at least 1 dose of drug.|||Percentage of Participants|||Number
1448089|NCT00866606|Secondary|Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)|The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Percentage of Participants|||Number
1448090|NCT00866606|Secondary|FIX Incremental Recovery|FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.|Baseline (Visit 2) up to 6 months (Visit 4)|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.|||IU/dL per IU/kg||Standard Deviation|Mean
1448091|NCT00866606|Secondary|Number of Infusions Required to Treat Each Bleed|The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.|Baseline up to 6 months|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Infusions||Standard Deviation|Mean
1448092|NCT00866606|Primary|Percentage of Participants With FIX Inhibitor Development|Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result >=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and <= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.|Baseline up to 6 months|Safety Set (SS) population included all enrolled participants who had taken at least 1 dose of drug.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively.|||Percentage of Participants|||Number
1448093|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|24 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
1448094|NCT00866606|Primary|Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion|Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.|8 hours post infusion|FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.|||Units on a scale||Standard Deviation|Mean
1448095|NCT00866359|Secondary|Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 197; maximum exposure was 25.1 weeks|Safety analyses for the apremilast-exposure period was based on the apremilast participants as treated (AAT) Population, and included those who were randomized (at the randomization visit) or switched (at the Day 85 visit) to apremilast 30 mg BID, and received at least one dose of apremilast after the initial randomization or switch to 30 mg BID.|||particpants|||Number
1448096|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase|||units on a scale||Standard Deviation|Mean
1448097|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 197|Not analyzed due to low numbers of genital ulcers; not considered meaningful.||||||
1448098|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response)|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 197|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
1448099|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase.|||units on a scale||Standard Deviation|Mean
1448100|NCT00866359|Secondary|Number of Oral Ulcers at Day 197|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 197|Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase|||ulcers/participants||Standard Deviation|Mean
1448101|NCT00866359|Secondary|Number of New Manifestations of Behçet’s Disease or Flare That Were Not Present at Day 1|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:~Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);~Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;~Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;~Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater;~New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||participants|||Number
1448102|NCT00866359|Secondary|Behçet's Disease (BD) Current Activity Index Form Score at Day 169|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Deviation|Mean
1448103|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 1 to Day 169|Not analyzed due to low numbers of genital ulcers; not considered meaningful.||||||
1448104|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Day 1 to Day 169|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline visit. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
1448114|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of oral ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||total AUC (#ulcers*days)||Standard Error|Least Squares Mean
1448105|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Deviation|Mean
1448106|NCT00866359|Secondary|Number of Oral Ulcers at Day 169|The number of oral ulcers were counted at Day 169 in reference to the participants’ first day of active treatment (Day 1 or Day 85).|Day 169|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||ulcers/participant||Standard Deviation|Mean
1448107|NCT00866359|Secondary|Number of New Manifestations of Behçet’s Disease or Flare During the Placebo Controlled Treatment Phase|"A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:~Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);~Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;~Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;~Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater'~New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis)."|Day 1 to Day 85|Safety population included all participants who were randomized and received at least 1 dose of Investigational Product.|||participants|||Number
1448108|NCT00866359|Secondary|Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase|A Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase|Safety Population defined as all participants who were randomized and received at least 1 dose of Investigational Product.|||participants|||Number
1448109|NCT00866359|Secondary|Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85|The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement.|Day 1 to Day 85 or to early termination visit|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Error|Least Squares Mean
1448110|NCT00866359|Secondary|Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)|Comparison of the percentage of participants who were oral ulcer-free (complete response: free from active oral ulcers), or whose oral ulcers were reduced by ≥ 50%, (partial response) between the apremilast-treated and the placebo-treated groups. In this case, partial response also includes complete response.|Baseline and Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
1448111|NCT00866359|Secondary|Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85|Sum of the number oral ulcers, genital ulcers or oral plus genital ulcers at Day 85|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||Ulcers/participants||Standard Error|Least Squares Mean
1448112|NCT00866359|Secondary|Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85|Area under curve (AUC) from Day 1 to Day 85 (AUC^85) for the number of oral plus genital ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values.|Day 1 to Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||total AUC (#ulcers*days)||Standard Deviation|Mean
1448113|NCT00866359|Secondary|Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85|Area under curve (AUC^85) from Day 1 to Day 85 for the number of genital ulcers per day was not analyzed.|Day 1 to Day 85|No population analyzed due to small number of participants with genital ulcers; not considered meaningful.||||||
1448228|NCT00864513|Secondary|Number of Participants With Adverse Events|Toxicity by National Cancer Institute Common Toxicity Criteria Adverse Event Version 3.0|30 days after last dose of study drug||||participants|||Number
1448115|NCT00866359|Secondary|Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85|A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Baseline to Day 85|Not analyzed due to low numbers of genital ulcers; not considered meaningful.||||||
1448116|NCT00866359|Other Pre-specified|Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85|The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)|Baseline to Day 85|Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation.|||percentage of participants|||Number
1448117|NCT00866359|Secondary|Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85|A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.|Day 85|The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||units on a scale||Standard Error|Least Squares Mean
1448118|NCT00866359|Primary|Number of Oral Ulcers at Day 85|The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).|Day 85|Intent to Treat (ITT) = all randomized participants with at least one oral ulcer evaluation (including the baseline visit). A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation.|||ulcers/participants||Standard Error|Least Squares Mean
1448119|NCT00866320|Secondary|Duration of Overall Response (Tumor Burden Reduction)|Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.|followed for overall response for approximately 3 years|Patients who achieved at least 5% tumor reduction|||months||95% Confidence Interval|Median
1448120|NCT00866320|Secondary|Time to Progression|"Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.~Progression-free survival measured in months and summarized using the Kaplan-Meier method."|followed to progression for approximately 3 years|All patients who started treatment|||months||95% Confidence Interval|Median
1448121|NCT00866320|Secondary|Overall Survival|Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.|followed until progression or death for approximately 3 years|All patients who started treatment|||months||95% Confidence Interval|Median
1448122|NCT00866320|Primary|Tumor Burden Reduction Rate (TBRR)|The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.|at 8 weeks (2cycles of treatment)|All patients who started treatment|||percentage of patients|||Number
1448123|NCT00866307|Primary|AALL08P1 Feasibility Outcome|Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)|||percentage of participants||90% Confidence Interval|Number
1448124|NCT00866307|Primary|AALL08P1 Safety Outcome|Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.|Consolidation through Delayed Intensification|Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)|||percentage of participants||90% Confidence Interval|Number
1448125|NCT00866294|Secondary|Percentage of Responders Based on the Clinical Global Impression-Global Improvement (CGI-GI) Scores at Weeks 4 and 8|The 7-point CGI-GI assesses the participant's improvement or worsening from baseline. Scores on the CGI-GI range from 1 = very much improved to 7 = very much worse. Responders are defined as participants with a score of 1 or 2 = much improved.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.|||percentage of responders|||Number
1448148|NCT00866047|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to approximately 3 years|Participants with objective response among the intention to treat population|||months||95% Confidence Interval|Median
1448126|NCT00866294|Secondary|Mean Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 3, 4, 6, and 8|The 7-point CGI-SI scale assesses the clinician’s impression of the participant's current illness state. Scores on the CGI-SI range from 1 = not ill at all to 7 = among the most extremely ill. Mean change from baseline was calculated as the value at each time point minus the baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they had missing values or they were withdrawn prematurely.|||scores on a scale||Standard Deviation|Mean
1448127|NCT00866294|Secondary|Percentage of HAM-D Remitters at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Remitters are defined as participants with a HAM-D total score of 7 or less.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.|||percentage of remitters|||Number
1448128|NCT00866294|Secondary|Percentage of HAM-D Responders at Weeks 4 and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is a sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Responders are defined as participants with a 50 percent or greater reduction from baseline in the HAM-D total score.|Weeks 4 and 8|FAS. The analysis was performed on the OC dataset. The analysis of Week 8 data was also performed on the LOCF dataset, where missing values were imputed by the last observed value in the longitudinal data. Some participants in each group were not included in the OC analysis because they were withdrawn prematurely.|||percentage of responders|||Number
1448129|NCT00866294|Secondary|Mean Change From Baseline in the HAM-D Total Score at Weeks 1, 2, 3, 4, 6, and 8|The HAM-D measures the severity of depressive symptoms in participants with MDD. It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at each time point minus the Baseline value.|Baseline (Week 0); Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the following datasets: the observed case (OC) dataset for Week 1 and the LOCF dataset for Weeks 2, 3, 4, 6, and 8, where missing values were imputed by the last observed value in the longitudinal data. One participant in the Paroxetine CR group was not included in the OC analysis for having a missing value.|||scores on a scale||Standard Deviation|Mean
1448130|NCT00866294|Primary|Adjusted Mean Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Week 8|The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.|Baseline (Week 0) and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase (8 weeks), excluding those who had taken no dose of the investigational product for the treatment phase and who had no data on the HAM-D total score after the start of the treatment phase. The analysis was performed on the last observation carried forward (LOCF) dataset.|||scores on a scale||Standard Error|Mean
1448131|NCT00866281|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs or SAEs and Death During the Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. On treatment death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment) up to End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in safety set population, defined as the participants who received at least one dose of midostaurin.|||Participants|||Number
1448132|NCT00866281|Secondary|Plasma Concentrations of Midostaurin and Its Metabolites CGP52421 and CGP62221|The plasma concentrations of midostaurin (PKC412) and its two major metabolites, CGP62221 and CGP52421 were determined by using a validated liquid chromatography/tandem mass spectrometry method.|Day 1, Day 5, Day 7, Day 15 (Day 1 of Cycle 2), Day 29 (Day 1 of Cycle 3)|The analysis was performed in pharmacokinetic (PK) set population defined as all safety set participants who had at least one valid (measurable) PK sample of midostaurin, and who had no significant restricted co-medications.|||nanograms/milliliters (ng/mL)||Standard Deviation|Mean
1448133|NCT00866281|Secondary|Overall Survival With Midostaurin|Overall survival (OS) was defined as the time from start of treatment to date of death due to any cause. The percentage (%) event-free probability estimates were obtained from the Kaplan-Meier survival estimates.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in FAS population.|||Months||95% Confidence Interval|Median
1448149|NCT00866047|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
1448150|NCT00866047|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
1448134|NCT00866281|Secondary|Time to Response With Midostaurin|Time to response was defined as the time from the date of start of midostaurin treatment to the date of first response. The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Time to response was calculated by using the formula = (date of first response -date of start of midostaurin) +1 day.|Baseline, End of treatment (up to 24 months after last dose or until death whichever occurred first)|"The analysis was performed in FAS population. Here, Number of participants analysed signifies number of responders at specified time points for each arm, respectively."|||Days||Full Range|Median
1448135|NCT00866281|Secondary|Percentage of Participants With Best Overall Response by Indication|The best overall clinical response was determined as per the clinical assessment done by the investigator. Responders were defined as all participants with a best clinical response of leukemia free state, morphological complete remission, incomplete morphological complete remission, partial remission, bone marrow blast response, bone marrow minor blast response, peripheral blood blast response, minor peripheral blood blast response. Participants with stable disease, progressive disease and with missing tumour assessment or who discontinued the study or who died before having their first assessment were considered as non-responders. Stable disease was defined as failure to achieve any of the above response. Progressive disease was defined as doubling of the bone marrow blast percentage from baseline in participants with <40% bone marrow blasts at baseline, or a 50% increase in bone marrow blast percentage from baseline in participants with >40% bone marrow blasts at baseline,|Baseline, Day 15 (Day 1 of Cycle 2), Day 22 (Day 8 of Cycle 2), Day 29(Day 1 of Cycle 9), End of treatment (up to 24 months after last dose or until death whichever occurred first)|The analysis was performed in full analysis set (FAS) population, defined as all participants to whom study treatment was assigned.|||Percentage of Participants|||Number
1448136|NCT00866281|Primary|Maximum Tolerated Dose (MTD) of Midostaurin- Posterior Probability of DLT|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT), based on a Bayesian logistic regression model (BLRM) employing the escalation with overdose control (EWOC) principle. A DLT was defined as a grade 3 or 4 non-hematological adverse event (AE) or abnormal laboratory value related to study drug. Mean and the 95% posterior probability estimates of having a DLT by age strata and dose is presented. Estimation of MTD and/or recommended dose for expansion (RDE) at the dose-escalation phase of the study was based upon the estimation of the probability of DLT for participants in the dose-determining set (DDS).|Baseline, End of dose escalation phase (6 months)|The analysis was performed in dose determining set (DDS) population. Here, 'n' signifies the number of evaluable participants for this measure.|||probability estimates||97.5% Confidence Interval|Mean
1448137|NCT00866177|Primary|Anti-tumor Response Defined as Either a CR, PR, or SD as Defined by RECIST|Anti-tumor response defined as either a Complete Response, Partial Response, or Stable Disease as defined by RECIST|Up to 4 weeks||||participants|||Number
1448138|NCT00866047|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||days||Full Range|Median
1448139|NCT00866047|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
1448140|NCT00866047|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline|||percent of participants||95% Confidence Interval|Number
1448141|NCT00866047|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
1448142|NCT00866047|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
1448143|NCT00866047|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
1448144|NCT00866047|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment|||participants|||Number
1448145|NCT00866047|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to approximately 7 years|Intention to treat|||months||95% Confidence Interval|Median
1448146|NCT00866047|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to approximately 3 years|Intention to treat|||months||95% Confidence Interval|Median
1448147|NCT00866047|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to approximately 3 years|Participants with complete remission among the intention to treat population|||months||95% Confidence Interval|Median
1448154|NCT00865904|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
1448155|NCT00865904|Secondary|Maximum Plasma Concentration (Cmax) of VX-809|Only participants who received VX-809 were analyzed for this outcome measure.|Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, 24, and 30-60 hours post dose)|FAS. Here, n = participants evaluable for specified category for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1448156|NCT00865904|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Domain Scores at Day 28|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. CFQ-R domains include: Body, Digestion, Eat, Emotion, Health Perceptions, Physical, Respiratory, Role, Social, Treatment Burden, Vitality, and Weight. Individual domain score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||units on a scale||95% Confidence Interval|Least Squares Mean
1448157|NCT00865904|Secondary|Change From Baseline in Nasal Potential Difference (NPD) of Zero Chloride Plus Isoproterenol Response at Day 28|"Nasal potential difference (NPD) provides a direct and sensitive evaluation of sodium and chloride transport in secretory epithelial cells via assessment of transepithelial bioelectric properties. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol is reported.~NPDs were performed according to Cystic Fibrosis Foundation Therapeutics Development Network (CFFT TDN) Standard Operating Procedure (SOP) 528.00 “Standardization of Measurement of Nasal Membrane Transepithelial Potential Difference (NPD) – electronic data capture (EDC) and Perfusion or Perfusion-Free Probe”."|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||millivolts (mV)||95% Confidence Interval|Least Squares Mean
1448158|NCT00865904|Secondary|Change From Baseline in Sweat Chloride at Day 28|Sweat samples were collected using an approved Macroduct (Wescor) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
1448159|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Flow Over the Middle Half of the FVC (FEF25-75) at Day 28|FEF25-75 is total volume of air exhaled from the lungs over the middle half of the FVC test, expressed as liters per second (L/sec).|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||liters per second (L/sec)||Standard Deviation|Mean
1448160|NCT00865904|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Day 28|FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||liters||Standard Deviation|Mean
1448161|NCT00865904|Secondary|Change From Baseline in Percent Predicted FEV1 at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method.|Baseline, Day 28|FAS. Number of participants analyzed signifies participants evaluable for this outcome.|||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
1448162|NCT00865904|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Number of participants analyzed signifies participants evaluable for this outcome.|||liters||95% Confidence Interval|Least Squares Mean
1448163|NCT00865904|Primary|Safety and Tolerability Based on Adverse Events (AEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. Serious adverse event (SAE) (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. An AE that started at or after initial dosing of study drug, or increased in severity after initial dosing of study drug visit is considered treatment-emergent.|Up to 14 days after last dose (last dose = Day 28)|Safety set included all participants who received at least 1 dose of study drug.|||participants|||Number
1448164|NCT00865709|Secondary|Duration of Response|Duration of Response was defined as the time from date of first response (Complete Response (CR) or Partial Response (PR)) to the date when Progressive Disease (PD) was first documented or to the date of death, whichever occurred first according to Response Evaluation Criteria in Solid Tumors (RECIST). Subjects still having CR or PR and alive at the time of analysis were censored at their last date of tumor evaluation. CR was defined as disappearance of tumor lesions, PR as a decrease of at least 30% and PD as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks|Duration of response was the time from the first documented CR or PR until the first documented PD or death (if before progression). Only responders (CR or PR) were included in the analysis|||months||95% Confidence Interval|Number
1448165|NCT00865709|Secondary|Overall Response|Overall response of a subject was defined as the best tumor response (Complete Response (CR) or Partial Response (PR)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).|||participants|||Number
1448322|NCT00863434|Primary|Disease-free Survival||Every 3 months for 2 years, and then annually for 3 years||||months||Full Range|Median
1448166|NCT00865709|Secondary|Time to Progression (TTP)|Time to progression (TTP) was defined as the time from date of randomization to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).|||Months||95% Confidence Interval|Median
1448167|NCT00865709|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first subject until 33 months later.||||days||95% Confidence Interval|Median
1448168|NCT00865709|Primary|Progression-Free Survival (PFS)|Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression or death due to any cause, whichever occurred first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Disease progression was defined as an increase of at least 20% in the sum of tumor lesions sizes.|From randomization of the first subject until 23 months later, assessed every 8 weeks.|The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).|||Months||95% Confidence Interval|Median
1448169|NCT00865514|Secondary|Inhibition of Tyrosine and Individual's Haplotype|Given the infusion of the above amino acids and DCA administration the inhibition of tyrosine will be measured in the KRT haplotype and non KRT haplotype.|one week|No statistical analysis. The data was incomplete and was not analyzed.||||||
1448170|NCT00865514|Primary|The Interaction of DCA and/or Tyrosine Breakdown Products and Maleylacetoacetate Isomerase (MAAI) in Vivo.|"Subjects are administered an infusion of the amino acids leucine and tyrosine. The next day they start a five day course of dichloroacetate(DCA). At the end of five days they receive another infusion of tyrosine and leucine.~The pharmacokinetics of DCA is calculated following the second infusion."|One week|No statistical analysis. The data was incomplete and was not analyzed.||||||
1448171|NCT00865345|Secondary|Device Related Moderate or Device Related Severe Adverse Events|Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy Device related severe adverse event: interrupts a subject’s daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.|days one through six of sensor wear||||events|||Number
1448172|NCT00865345|Primary|Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)|The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.|Days one through six of sensor use|61 subjects of 63 enrolled subjects (a total of 4971 paired YSI and sensor readings) completed participation in the inpatient frequent blood sampling procedure.|||paired YSI/sensor glucose values|Participants|95% Confidence Interval|Number
1448173|NCT00865306|Other Pre-specified|Number of Responders Using Clinical Global Impression-Anxiety Improvement at 1-Year Follow-Up|"Clinicians rated improvement on anxiety since baseline using the Clinical Global Impression-Anxiety Improvement scale (Best 1, Worst 7), with children considered responders if they were rated 1, very much improved or 2, much improved. Note that rates for controls are for controls who were subsequently treated with CBT (after completing the wait-list control condition)."|1-Year Follow-Up|"We tabulated the number of children that were much or very much improved on anxiety since baseline. Note that the controls who were followed up at one-year were those who subsequently received CBT (after participating in the wait-list condition). Therefore the No intervention (wait-list controls) followed up here had actually received CBT."|||Participants|||Number
1448174|NCT00865306|Other Pre-specified|Number of Children Free of Anxiety Disorders|Number of children free of anxiety disorders, as assessed by clinicians blind to treatment condition.|Post-Treatment (6-months from baseline)||||Participants|||Number
1448175|NCT00865306|Primary|Number of Responders Based on Clinician Global Impression-Anxiety Improvement|"Clinicians blind to treatment assignment rated the child's global improvement on anxiety, using the Clinician Global Impression-Anxiety Improvement scale (CGI-Anxiety, best value 1, worst value 7). Responders were considered those with very much or much improvement (CGI-Anxiety scores of 1 or 2)"|Post-Treatment (6-months from baseline)||||Participants|||Number
1448176|NCT00865202|Secondary|Length of Post-operative ICU and Hospital Stay||length of post-op hospital stay||||days||Standard Deviation|Mean
1448177|NCT00865202|Secondary|Level of Post-operative Melatonin||Blood draw on post-operative day number two||||pg/mL||Standard Deviation|Mean
1448178|NCT00865202|Secondary|Level of Post-operative Serum Tryptophan||post-operative day number two blood draw||||umol/L||Standard Deviation|Mean
1448179|NCT00865202|Secondary|Incidence of Post-operative Delirium|"The incidence and/or duration of excitatory (hyperactive and mixed) post-operative delirium, diagnosed by the Confusion Assessment Method-ICU (CAM-ICU) with the Richmond Agitation Sedation Score (RASS), will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission.~The incidence and/or duration of all types of post-operative delirium, diagnosed by the CAM-ICU with the RASS, will be reduced with enteral L-tryptophan supplementation (1 gm TID for the first 3 post-op days), compared to placebo, in older patients (≥ 60 years) undergoing operations requiring ICU admission."|post-operatively daily in ICU until discharged from ICU||||percentage of patient escitatorydelirium|||Number
1448180|NCT00865202|Primary|Duration of Post-operative Delirium||post-operatively daily in ICU until discharged from ICU||||days||Standard Deviation|Mean
1448181|NCT00865189|Secondary|Percentage of Participants With Surgery|The surgery involving a radical rectal excision using the TME technique.|Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment|ITT population|||percentage of participants|||Number
1448182|NCT00865189|Secondary|Number of Cycles of Radiotherapy||Arm A: Week 16 to Week 23; Arm B: Week 1 to Week 7|ITT population|||cycles||Standard Deviation|Mean
1448187|NCT00865189|Secondary|Disease-Free Survival (DFS)|The DFS was defined as the time from the first treatment intake to disease recurrence assessed (second primary cancer, local or distant recurrence, distant metastases) or death from any cause. The DFS was analyzed using Kaplan-Meier method.|From first time of the treatment administration to the date of second cancer, local or regional recurrence, distant metastasis or death from any cause (up to approximately 6 years)|ITT population|||months||95% Confidence Interval|Median
1448188|NCT00865189|Secondary|Percentage of Participants With Second Cancer, Local or Regional Recurrence, Distant Metastasis, or Death||Baseline up to approximately 6 years|ITT population|||percentage of participants|||Number
1448189|NCT00865189|Secondary|Percentage of Participants With Local and Distant Recurrences|The percentage of participants with a recurrence was described by type of recurrence (local and distant recurrence).|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population|||percentage of participants||95% Confidence Interval|Number
1448190|NCT00865189|Secondary|Percentage of Participants With Tumor Down-Staging (ypT0-pT2)|A participant with a downstaging was defined as a participant with T3 (T describes the size of the original [primary] tumor) at inclusion and T2 or T1 or T0 after surgery, or with N+ (N describes lymph nodes involvement) at inclusion and N- after surgery and if T is equal at inclusion and after surgery. The clinical tumor-node-metastasis (cTNM) classification was used at inclusion and the pathological staging tumor and nodes (ypTN) classification after surgery. Reported is the percentage of participants with tumor downstaging of the surgical specimen according to the local review and centralized review.|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable for specified category.|||percentage of participants||95% Confidence Interval|Number
1448191|NCT00865189|Primary|Percentage of Participants With Tumor Sterilization Defined by ypT0-N0|Tumor sterilization was defined as the absence of residual tumor cells in the resected specimen including lymph nodes (ypT0-N0). The rate of sterilization of the tumoral specimen was assessed after surgery on the surgical specimen by local review. Analyses were performed for participants who have been operated as defined by the protocol (within the study and TME technique) and for all participants who have been operated. Reported is the percentage of participants with tumor sterilization.|After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants||95% Confidence Interval|Number
1448192|NCT00865124|Secondary|Change in Renal Plasma Flow|Renal vasculature was assessed by examining renal plasma flow, or para-aminohippurate (PAH) clearance, basally and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II.|Baseline and six months|All participants with data available for this outcome measure at the given time-point.|||mL/min/1.73m^2||Standard Deviation|Mean
1448193|NCT00865124|Secondary|Mitral Annulus Velocities on Tissue Doppler (Delta E/e’ Ratio), a Measure of Diastolic Function (With Angiotensin II)|Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment; and in response to acute administration (3 nanograms/kg/min for 60 min) of the vasoactive agent, Angiotensin II.|Baseline and six months|All participants with data available for this outcome measure at the given time-point.|||ratio||Standard Deviation|Mean
1448194|NCT00865124|Secondary|Change in Mitral Annulus Velocities on Tissue Doppler (Delta E/e’ Ratio), a Measure of Diastolic Function|Diastolic function was assessed via tissue doppler imaging (TDI) by echocardiography to determine left ventricular diastolic function before and after 6 months of treatment.|Baseline and six months|All participants with data available for this outcome measure.|||ratio||Standard Deviation|Mean
1448195|NCT00865124|Primary|Change in Coronary Flow Reserve From Baseline to 6 Months|Coronary flow reserve (CFR), or myocardial perfusion reserve, was assessed via cardiac positron emission tomography (PET). CFR is the ratio of adenosine-stimulated blood flow through myocardium to resting blood flow through myocardium. An improvement in coronary flow reserve is beneficial.|Baseline and six months|All participants with data available for this outcome measure.|||ratio||Standard Deviation|Mean
1448196|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Infusion Related Reaction|Infusion related reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
1448197|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 3 or 4 Skin Reaction|Skin reactions were considered as adverse events of special interest and were evaluated in a special AE category composed of specific MedDRA preferred terms. Severity was assessed according to criteria defined in the NCI-CTCAE, Version 3.0, where grade 1 is mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
1448198|NCT00865098|Secondary|Safety - Number of Patients Experiencing Any Grade 4 Adverse Event|Severity was assessed according to the toxicity criteria defined in the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE), Version 3.0, where grade 1 denoted mild, grade 2 moderate, grade 3 severe, and grade 4 lifethreatening or disabling. In the case of adverse events not contained within the NCI-CTCAE, the investigator was responsible for assessing the severity of the AE (grades 1 to 4) based on the jeopardy to the subject’s health and well-being, and the ability of the subject to function during the event.|time from first dose up to 60 days after last dose of study treatment, ≤18 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||participants|||Number
1448323|NCT00863434|Primary|Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry|Percent of white blood cells that are blasts in the bone marrow post-treatment.|Post-treatment||||percent of white blood cells||Full Range|Median
1448200|NCT00865098|Secondary|Best Response Rate|Number of subjects experiencing a Complete Response (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (>=50% decrease of the sum of the product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions) at 8 weeks post radiotherapy (confirmed by repeat assessment at week 12) based on imaging according to modified World Health Organisation criteria as assessed independently by the Efficacy and Safety Evaluation Committee, divided by the number of subjects in the ITT/safety population|best response was determined at week 8 post radiotherapy, for subjects with complete or partial response a confirmation in week 12 post radiotherapy was required|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||percentage of participants||95% Confidence Interval|Number
1448201|NCT00865098|Primary|Completion Rate|Number of subjects who complete ≥70% of Cetuximab planned dose administration in terms of relative dose intensity of Cetuximab and full dose of RT ≤2 weeks over planned schedule in terms of RT duration ≤8 weeks, divided by the the number of subjects in the ITT/Safety population|time from first administration of cetuximab to last administration of cetuximab or RT (whichever is later), ≤ 9 weeks|ITT/Safety population, i.e. all subjects who have received at least one dose of the study treatment|||percentage of participants||95% Confidence Interval|Number
1448202|NCT00865046|Primary|Pain (WOMAC)|"The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales:~Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome)"|9 months following baseline||||units on a scale||Standard Error|Mean
1448203|NCT00865020|Secondary|Change in the Mean Diastolic Sitting Blood Pressure (msDBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 min. apart were used in the analysis.~The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msDBP as a covariate.~The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.|||mmHg||Standard Error|Least Squares Mean
1448204|NCT00865020|Secondary|Change in the Mean Sitting Systolic Blood Pressure (msSBP) as Measured at All Study Visits During the Double-blind Treatment Period and During the Treatment Withdrawal Period|"Blood Pressure was measured in the office after the patient was sitting for 5 minutes. The average of 3 readings 1-2 minutes apart were used in the analysis.~The change in the double-blind period was calculated from the end of active treatment at week 12 to the Baseline (Randomization) using Analysis of Covariance with treatment and region as factors and baseline msSBP as a covariate.~The change in the treatment interruption period was calculated from day 7 of the withdrawal period at week 13 to the end of the active treatment using Analysis of Variance with treatment and region as factors."|Baseline, 12 weeks, 13 weeks|Full Analysis set consisting of all participants randomized to treatment. n1=participants with measurements at baseline and end of the active treatment period for the Double-blind Period. n2=participants with measurements at the end of the active treatment period and end of the treatment withdrawal period for the Treatment Interruption Period.|||mmHg||Standard Error|Least Squares Mean
1448205|NCT00865020|Secondary|Change in 24-hr Mean Ambulatory Systolic Blood Pressure (MASBP) and Mean Ambulatory Diastolic Blood Pressure (MADBP) From Baseline to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at Baseline (at Randomization) and at week 13 (day 7 of the withdrawal period). The 4 Hour MASBP and MADBP was calculated by taking the mean of all Ambulatory Blood Pressure readings during the 24 hour period. The difference of the 24 hour measurements from baseline to day 7 of the withdrawal period were calculated using a two way analysis of variance with treatment and region as factors and baseline as a covariate.|Baseline, 13 weeks|Full Analysis Set consisting of all participants randomized to treatment with measurements at baseline and day 7 of the withdrawal period.|||mmHg||Standard Error|Least Squares Mean
1448206|NCT00865020|Secondary|Change in 24 Hour (24-hr) Mean Ambulatory Diastolic Blood Pressure (MADBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MADBP was calculated by taking the mean of all Ambulatory Diastolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MADBP from the end of the active treatment to Day 7 of the withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.|||mmHg||Standard Error|Least Squares Mean
1448207|NCT00865020|Primary|Change in 24 Hour (24-Hr) Mean Ambulatory Systolic Blood Pressure (MASBP) From the End of the Active Treatment Period to Day 7 of the Withdrawal Period|An Ambulatory Blood Pressure Monitor measured a participants's blood pressure over a 24 hour period using an automated validated monitoring device at week 12 (end of the active treatment) and at week 13 (end of the day 7 withdrawal period). The 24 Hour MASBP was calculated by taking the mean of all Ambulatory Systolic Blood Pressure readings for the 24 hour period. The difference of the 24 hour MASBP from the end of the active treatment to Day 7 of the treatment withdrawal period was calculated using a two way analysis of variance with treatment and region as factors.|12 weeks, 13 weeks|ABPM Completer Set consisting of all participants in the Full Analysis set who had ABPM measurements at the end of the active treatment period and Day 7 of the treatment withdrawal period.|||mmHg||Standard Error|Least Squares Mean
1448208|NCT00864916|Primary|Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation (% dilation of the brachial artery) at week 48|Measured at Week 48|Numbers of participants who completed the week 48 visit procedures|||percent dilation of the brachial artery||Standard Deviation|Mean
1448209|NCT00864851|Secondary|Safety Evaluation|Adverse events were collected throughout the study, from the time of informed consent to approximately 30 days post-final infusion.|56 Weeks|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal. Analyses were performed on the ITT population because it was identical to the safety population.|||participants|||Number
1448210|NCT00864851|Secondary|Change From Baseline to Month 12 in Urinary Albumin/Creatinine (A/Cr) Ratio||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||mg/g||Standard Deviation|Mean
1448211|NCT00864851|Secondary|Change From Baseline to Month 12 in Estimated Glomerular Filtration Rate (eGFR)|Renal function was assessed by an evaluation of change from baseline to Month 12 in eGFR as calculated using the Modification of Diet for Renal Disease (MDRD) equation.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||mL/min/1.73m^2||Standard Deviation|Mean
1448212|NCT00864851|Secondary|Change From Baseline to Month 12 in Plasma Globotriaosylceramide (GB3)||Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||nmol/ml||Standard Deviation|Mean
1448213|NCT00864851|Secondary|Change From Baseline to Month 12 in New York Heart Association (NYHA) Functional Class|"The NYHA functional classification system relates symptoms to everyday activities and the patient's quality of life.~NYHA Classification - The Stages of Heart Failure:~Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).~Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased."|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||participants|||Number
1448214|NCT00864851|Secondary|Change From Baseline to Month 12 in the Minnesota Living With Heart Failure Questionnaire (MLHF-Q) Summary Score|Quality of life (QoL) was evaluated using the MLHF-Q, version 2. The questionnaire is designed to assess the degree to which heart failure symptoms affect a patient's daily life. The summary score ranges from 0 to 105, with a score of 105 representing the highest adverse impact on a patient's QoL.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||scores on a scale||Standard Deviation|Mean
1448215|NCT00864851|Secondary|Change From Baseline to Month 12 in Distance Walked in 6-Minute Walk Test (6MWT)|Exercise tolerance using the 6MWT was measured as the total distance walked in 6 minutes.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||m||Standard Deviation|Mean
1448216|NCT00864851|Secondary|Change From Baseline to Month 12 in Maximal Oxygen Consumption (VO2 Max) at Peak Exercise|Exercise tolerance as measured by VO2 max at peak exercise using the standard exponential exercise protocol (STEEP).|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||mL/min/kg||Standard Deviation|Mean
1448217|NCT00864851|Primary|Change From Baseline to Month 12 in Left Ventricular Mass Indexed to Height (LVMI)|Left ventricular mass (LVM) was measured through echocardiography.|Baseline, Month 12 (Week 53)|Intent to Treat (ITT) Population: All randomized patients who received at least 1 complete or partial dose of Replagal.|||g/m^2.7||Standard Deviation|Mean
1448218|NCT00864708|Primary|Kinematic Gait Measures|assessment of the lower limb kinematics during ambulation at chosen speed.|Day 1 and at 3 months, following treatment||||percentage of change Day 1 to 3 months|||Number
1448219|NCT00864708|Secondary|Manual Muscle Testing (MMT)|This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)|Day 1 and at 3 months, following treatment||||units on a scale|||Number
1448220|NCT00864708|Secondary|Stroke Impact Scale (SIS)|The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).|Day 1 and at 3 months, following treatment||||units on a scale|||Number
1448221|NCT00864708|Secondary|Ashworth Scale|The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)|Day 1 and at 3 months, following treatment||||units on a scale|||Number
1448222|NCT00864708|Secondary|Fugl-Meyer Lower Extremity Score|Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).|Day 1 and at 3 months, following treatment||||units on a scale|||Number
1448223|NCT00864708|Primary|Walking Endurance (6MWT)|The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.|Day 1 and at 3 months, following treatment||||feet|||Number
1448224|NCT00864682|Secondary|Satisfaction With Anesthetic Technique|Were you satisfied with the anesthetic technique? Yes/No|Prior to discharge. One time assessment||||Participants|||Number
1448225|NCT00864682|Secondary|Complete Alleviation of Injection Pain|Total subjects within the arm versus those subjects who had no pain with injection (VPS=0)|Immediately after injection of study drug. One time assessment||||Participants|||Number
1448226|NCT00864682|Primary|Verbal Pain Score|11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain|Immediately after injection of study drug. One time assessment.||||Units on a scale||Inter-Quartile Range|Median
1448227|NCT00864539|Primary|Serum Levels of 25hydroxy Vitamin D(25(OH)D)Compared to the Due Control Group|Serum level of 25(OH)D was determined using competitive protein binding assay (CPBA) method.|10 weeks||||nmol/L||Standard Deviation|Mean
1448229|NCT00864513|Secondary|CA 19-9 Response|CA 19-9 was evaluatd every three weeks, before the next study treatment. Approximately 30% of patients are not expected to have detectable CA 19-9, based on Lews-Y antigen. CA 19-9 response is defined as more than 50% decrease from baseline.|Within two months of the last dose of chemotherapy|Only 10 patients had elevated CA 19-9 at the start of therapy, and were therefore analyzable for this endpoint|||participants|||Number
1448230|NCT00864513|Secondary|Objective Response|Evaluation of tumor extent by CT scans, according to RECIST criteria (a 20% decrease in the sum of the longest unidimensional measurements of existing disease), version 1.0|Within two months of the completion of the last dose of chemotherapy||||participants|||Number
1448231|NCT00864513|Primary|Progression-free Survival|Number of days from first dose of study treatment until the date of progression, as measured by worsening disease (new site of disease, or increase in existing disease) or death.|6 months after last patient enrolled||||days||Full Range|Median
1448232|NCT00864383|Secondary|Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media.|Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (“isolated positive culture”) was followed by at least two negative culture results.|18 months||||participants with unfavorable outcome|||Number
1448233|NCT00864383|Secondary|Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media.|Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result (“isolated positive culture”) was followed by at least two negative culture results.|18 months|All randomized subjects.|||participants with unfavorable outcome|||Number
1448234|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (MGIT Liquid Media)||18 months|All randomized patients excluding late screen failures|||Time to culture negative status / weeks||95% Confidence Interval|Median
1448235|NCT00864383|Secondary|Time to First Culture Negative Sputum Sample (LJ Solid Media)|Culture negative for TB using LJ cultures.|18 months|All randomized patients excluding late screen failures|||Time to culture negative status / weeks||95% Confidence Interval|Median
1448236|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Liquid MGIT Culture)|Number of patients who are TB MGIT culture negative at 8 weeks.|8 weeks||||participants who are culture negative|||Number
1448237|NCT00864383|Secondary|Number of Patients Who Are Culture Negative (Solid LJ Culture)|Number of patients who are TB LJ culture negative at 8 weeks.|8 weeks|Per protocol|||participants who are culture negative|||Number
1448238|NCT00864383|Secondary|Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT).|The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis.|18 months (within one year of completion of therapy)|Per protocol population|||participants with failure or relapse|||Number
1448239|NCT00864383|Primary|Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting)|The number of participants includes all patients who had at least one grade 3 or 4 adverse event.|18 months (within one year of completion of therapy)|Safety population, defined as all subjects who underwent randomization and who received at least on dose of study drug.|||participants with Grade 3 or 4 AEs|||Number
1448240|NCT00864383|Primary|Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ).|The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results.|18 months (within one year of completion of therapy)|Per protocol population|||participants with failure or relapse|||Number
1448241|NCT00864253|Secondary|Pharmacokinetic Parameters||On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose|Patients randomized to receive ABI-007 treatment in Australia, Canada, Europe, United Kingdom and United States had the option to participate in sparse PK sampling in this study. Only 44 participants consented to participate, an insufficient number to support the planned population PK analysis hence these analyses were not performed||||||
1448242|NCT00864253|Secondary|Nadir for the Hemoglobin Count Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included.|||g/L||Full Range|Median
1448243|NCT00864253|Secondary|Nadir for Platelet Count Measurements.|Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included|||10^9/L||Full Range|Median
1448244|NCT00864253|Secondary|Nadir for White Blood Cells (WBCs) Measurements|Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included|||10^9/L||Full Range|Median
1448245|NCT00864253|Secondary|Nadir for the Absolute Neutrophil Count (ANC) Measurements|Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.|Day 1 up to 106 weeks; up to data cut off 30 June 2012|Treated Population = consisted of all randomized participants who received at least one dose of study drug and with at least one post-baseline central laboratory result were included|||10^9/L||Full Range|Median
1448246|NCT00864253|Secondary|Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug|The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum study drug exposure 106 weeks; data cut off 30 June 2012|Treated population|||participants|||Number
1448247|NCT00864253|Secondary|Summary of Treatment-emergent Adverse Events (AEs)|"A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE’s were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale:~Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012|Treated Population = The Treated population consisted of all randomized participants who received at least one dose of study drug|||participants|||Number
1448248|NCT00864253|Other Pre-specified|Duration of Response (DOR) in Responding Participants|Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR. DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first. Participants that did not have progression or had not died were censored at the last known time the participant was progression free. Participants that had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #4. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|up to data cut off 30 June 2012|ITT of participants with a confirmed complete or partial overall response|||months||95% Confidence Interval|Median
1448249|NCT00864253|Other Pre-specified|Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response|"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions."|Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012|ITT|||percent of participants|||Number
1448250|NCT00864253|Other Pre-specified|Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0|RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.|every 8 weeks; up to data cut off 30 June 2012|ITT|||percentage of participants|||Number
1448251|NCT00864253|Other Pre-specified|Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.|Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months|ITT|||months||95% Confidence Interval|Median
1448252|NCT00864253|Secondary|Participant Survival|Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.|Up to 38 months; Up to data cut off of 30 June 2012|Intent to treat population|||months||95% Confidence Interval|Median
1448253|NCT00864253|Primary|Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines|PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.|Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012|Intent to treat population = The ITT population consisted of all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments collected.|||months||95% Confidence Interval|Median
1448254|NCT00864227|Secondary|Platelet Recovery to 50K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >50,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
1448255|NCT00864227|Secondary|Incidence of Infections|Number of participants that experienced at least one infection.|Measured at Year 1||||Infections|||Number
1448256|NCT00864227|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
1448257|NCT00864227|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval to relapse/ recurrence/progression, to death or to last follow-up.|Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
1448258|NCT00864227|Secondary|Chronic GVHD||Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
1448259|NCT00864227|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100||||percentage of participants||95% Confidence Interval|Number
1448260|NCT00864227|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56||||participants|||Number
1448261|NCT00864227|Secondary|Platelet Recovery to 20K|Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >20,000/mm3 with no platelet transfusions in the preceding seven days.|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
1448262|NCT00864227|Secondary|Secondary Graft Failure|Secondary graft failure is defined initial recovery followed by neutropenia with < 5% donor chimerism.|Measured at Day 100||||participants|||Number
1448263|NCT00864227|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements prior to and day-100.|Measured at Day 100||||participants|||Number
1448264|NCT00864227|Secondary|Neutrophil Recovery|Neutrophil recovery is defined as achieving an absolute neutrophil count ≥ 500/mm3 for three consecutive measurements on different days.|Measured at Days 28, 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
1448265|NCT00864227|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1||||percentage of participants||95% Confidence Interval|Number
1448266|NCT00864123|Secondary|Adverse Symptom Checklist (ASC; Goodman, 2005).|This index assesses adverse side effects that have been associated with DCS, as well as other commonly used psychotropic agents (e.g., SRIs). There are no summary scales for this. Rather, it reflects the presence or absence of 30 potential side effects on a 0-3 scale (0=not at all, 1=slight, 2=moderate, 3=severe) that are associated with study interventions.|Baseline, mid-treatment, post-treatment|Number of participants experiencing an adverse effect related to study interventions. This is a simple frequency count.|||participants|||Number
1448267|NCT00864123|Secondary|Clinical Global Impression – Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology.|The CGI-S is a 7-point clinician rating of severity of psychopathology. Ratings range from 1 (“no illness”) to 7 (“extremely severe”). A single rating is chosen for the CGI-S; thus, there are no summary scales/scores.|Baseline, mid-treatment, post-treatment||||units on a scale||Standard Deviation|Mean
1448268|NCT00864123|Primary|Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997).|The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. This measure served as the primary outcome index. Scores range from 0-40 with higher scores representing more severe symptoms.|Baseline, Mid-Treatment, Post-treatment||||units on a scale||Standard Deviation|Mean
1448269|NCT00864084|Primary|Standing Balance - Critical Point in Distance|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||cm||Standard Deviation|Mean
1448270|NCT00864084|Primary|Standing Balance - Critical Point in Time|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||s||Standard Deviation|Mean
1448271|NCT00864084|Secondary|Confidence in Disease Management|The COPD Self-Efficacy Scale evaluates level of confidence in ability to manage or avoid breathing difficulty during a range of situations such as feeling frustrated and lifting heavy objects {Wigal, 1991 #3}. Possible answers range from “very confident” (5 points) to “not at all confident” (1 point) and the average score per question is calculated. This scale has been shown to have excellent internal consistency and good test-retest reliability.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||scores on a scale||Standard Deviation|Mean
1448272|NCT00864084|Secondary|Fear of Falling|"The Falls Efficacy Scale International (FESI) assesses fear of falling during a range of physical and social activities {Yardley, 2005 #1}. It asks about an individual’s concern about the possibility of following during participation in sixteen common activities, such as cleaning the house, ascending and descending stairs and walking in various environmental conditions. Answers range from 1, “not at all” concerned, to 4, “very concerned, on a 4-point scale, and score is calculated as the average response. This questionnaire has been shown to have excellent internal and test-retest reliability {Yardley, 2005 #1}."|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||scores on a scale||Standard Deviation|Mean
1448273|NCT00864084|Secondary|Balance Confidence|Activity-Specific Balance Confidence (ABC) scale measures balance confidence during sixteen activities of progressive difficulty, such as going up and down stairs, reaching for objects and walking in crowded areas {Powell, 1995 #5}. It asks subjects to rate their level of confidence in performing an activity without losing balance on an 11-point scale ranging from 0% (no confidence) to 100% (completely confident). The score is calculated as the average score for each item. This questionnaire has been shown to be sensitive to detect changes in function following rehabilitation {Myers, 1998 #6} and has proven internal consistency and test-retest reliability {Powell, 1995 #5}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||units on a scale||Standard Deviation|Mean
1448274|NCT00864084|Primary|Dynamic Balance|Dynamic balance was measured using the timed up and go (TUG) and Four Square Step Test (FSST). For the TUG, the time taken for the subject to stand from a chair, walk 3 m, turn around and return to the chair was recorded {Podsiadlo, 1991 #31}. Subjects were asked to do this as quickly and safely as possible. High test-retest reliability of the TUG has been reported in older community-dwelling individuals {Steffen, 2002 #34}. In the FSST, subjects were asked to step to four corners of a square in a clockwise and then counter-clockwise direction as quickly as possible {Dite, 2002 #1181}. The time taken to complete this circuit was recorded. This test has been shown to have high inter-rater and test-retest reliability {Dite, 2002 #1181}.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||seconds||Standard Deviation|Mean
1448275|NCT00864084|Primary|Standing Balance - Sway Path|Standing balance was measured using a force plate (AMTI, Watertown, MA, USA) from which centre of pressure (COP) trajectories were derived at a sampling frequency of 100Hz. Participants stood on the force plate during the following two conditions: normal stance (feet hip-width apart) with eyes open and eyes closed.|Baseline (pre-pulmonary rehabilitation) and follow-up (post-pulmonary rehabilitation) at 8 weeks||||cm/s||Standard Deviation|Mean
1448276|NCT00864032|Primary|Number of Dose Limiting Toxicities|"Number of dose limiting toxicities and number with adverse events.~Dose-escalation schedule comprising 6 to 12 patients (see schema). This sample size is based on a traditional 3+3 cohort design with escalating doses of sorafenib in combination with 50 Gy of conformal radiotherapy delivered in 25 fractions (200 cGy per fraction). Based on preclinical data regarding the radiobiology of sorafenib,33, 36 sorafenib will be initiated at a dose of 200 mg twice daily, followed by 200 mg Q AM/400 mg Q PM for the 2nd cohort, followed by 400 mg bid for the 3rd cohort. Since 400 mg bid is the well established MTD for sorafenib monotherapy in patients with renal cell carcinoma and hepatocellular carcinoma, the dose will not be escalated above this level even if DLT is not observed. Dose level escalation will be determined based on DLTs observed from initiation of sorafenib/RT until time of surgery."|Approximately 12 weeks||||DLTs|||Number
1448277|NCT00863798|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS)|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms.|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1448278|NCT00863798|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of “Yes” on “Actual Attempt”),preparatory acts toward imminent suicidal behavior (3)(“Yes” on “Preparatory Acts or Behavior”),suicidal ideation (4)(“Yes” on “Wish to be dead”,“Non-Specific Active Suicidal Thoughts”,“Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(“Yes” on “Has subject engaged in Non-suicidal Self-Injurious Behavior”).|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Participants|||Number
1448279|NCT00863798|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week were instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Percentage of Participants|||Number
1448324|NCT00863356|Primary|Hemostasis Success|Successful hemostasis prior to leaving physician's office|From procedure to hemostasis.|All enrolled subjects|||percentage of participants|||Number
1448325|NCT00863356|Secondary|This Study Evaluates the Benefits Acquired by the Use This New Product in Terms of Presence/Absence of Post-packing Tissue Scarring. This Will be Accessed by Endoscopic Examination of the Nasal Cavity Following Removal of HemCon Material.||Removal: 48 hours. Follow-up: 1 week.|||||||
1448280|NCT00863798|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1448281|NCT00863798|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tools that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Error|Mean
1448282|NCT00863798|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.|||nanogram(ng)/mL||Standard Deviation|Mean
1448283|NCT00863798|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1448284|NCT00863798|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1448285|NCT00863798|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1448286|NCT00863798|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1448287|NCT00863798|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. 0=none/absent and 22=most severe.The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1448288|NCT00863798|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1448289|NCT00863798|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET )|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1448290|NCT00863798|Secondary|Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1448291|NCT00863798|Primary|Change From Baseline in HAM-D17 Total Score at Final On-therapy (FOT) Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.|||Units on a scale||Standard Error|Mean
1448292|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - VAS Score|A visual analogue scale (EQ VAS) used by patients to rate their current health state from 100 (best imaginable health state) to 0 (worst imaginable health state). The change of score ranges from -100 (high degree of worsening) to 100 (high degree of improvement)|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
1448293|NCT00863746|Secondary|Mean Change From Baseline in EuroQol-5D (EQ-5D) - Index Score|The Euro-Qol 5D (EQ-5D) is a validated assessment tool of Health Related Quality of Life (HRQOL) and utilities consisting of 15 statements. Patients select those statements that best describe their current health state regarding mobility, self-care, usual activities, pain/discomfort, and anxiety/depression which is converted into a utility value. Range of scale is from -0.594 (worst possible health state) to 1 (perfect health) based on UK weights. The change of score ranges from -1.594 (high degree of worsening) to 1.594 (high degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
1448294|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Dyspnea|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The dyspnea subscale uses questions 3, 4 and 5 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
1448295|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Coughing Subscale|A clinically valid 13-item tool for assessing disease- and treatment-specific symptoms in lung cancer patients in clinical trials. The coughing subscale uses question 1 of the questionnaire. The scale ranges from 0 to 100. Higher score means higher level of symptomatology/problems. The change of score ranges from -100 (decrease in level of symptomatology/problems) to 100 (increase in level of symptomatology/problems).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
1448296|NCT00863746|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health Status|The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The 'Global Health status' subscale consists of question 15 of the questionnaire. The score of 'Global Health status' ranges from 0 (very poor) to 100 (excellent). The change of score ranges from -100 (maximum degree of worsening) to 100 (maximum degree of improvement).|Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)|Patient report outcomes (PRO) analysis set|||Scores on a scale||Standard Deviation|Mean
1448297|NCT00863746|Secondary|Time to Progression|Time to progression (TTP) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier).|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
1448298|NCT00863746|Secondary|Objective Tumor Response|Objective tumor response was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Proportion of participants|||Number
1448299|NCT00863746|Secondary|Disease Control|Disease control (DC) was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] or Stable Disease [SD: steady state of disease which was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD)].|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Proportion of participants|||Number
1448300|NCT00863746|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Appearance of new lesions will also constitute progressive disease. In exceptional circumstances unequivocal progression of a non-measured lesion may be accepted as evidence of disease progression.|From randomization of the first subject until 36 months later assessed every 6 weeks|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
1448301|NCT00863746|Primary|Overall Survival|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. Overall survival of subjects alive at the time of analysis will be censored at their last date of follow-up or database cut off date whichever came first.|From randomization of the first subject until 36 months later|Full Analysis Set (FAS)|||Days||95% Confidence Interval|Median
1448302|NCT00863707|Primary|Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)|"The data represents the numbers of subjects reporting Serious TEAEs.~TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug."|24 hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.|||Subjects|||Number
1448303|NCT00863655|Secondary|Estradiol Plasma Concentrations|Compare estradiol concentrations from baseline to week 4 in both treatment arms.|Baseline, Week 4|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.|||pg/mL||Standard Deviation|Mean
1448304|NCT00863655|Secondary|Exemestane Concentrations at Week 4|Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.|predose, 2 hours post-dose|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
1448305|NCT00863655|Secondary|Everolimus Concentrations at Week 4|Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.|pre-dose, 2 hours post-dose|Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose & 2 hours post-dose values for the given time points were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
1448306|NCT00863655|Secondary|Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier|Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|21 months|Randomized patients with best overall response of CR or PR.|||Months||95% Confidence Interval|Median
1448307|NCT00863655|Secondary|Proportion of Patients With Having no Overall Response Based on Investigator Assessment|overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|2, 4, 6, 9 months|All randomized patients were included in the Full Analysis Set.|||Proportion of patients||95% Confidence Interval|Number
1448308|NCT00863655|Secondary|Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30|"The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms."|Up to 21 months|All randomized patients were included in the Full Analysis Set.|||Months||95% Confidence Interval|Median
1448309|NCT00863655|Secondary|Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier|The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, & physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature. 2: Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement.|2, 4, 6, 9 months|All randomized patients were included in the Full Analysis Set.|||Proportion of patients||95% Confidence Interval|Number
1448310|NCT00863655|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) >= 24 weeks, according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.|up to 21 months|All randomized patients were included in the Full Analysis Set.|||Percentage of participants|||Number
1448311|NCT00863655|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.|up to 21 months|All randomized patients were included in the Full Analysis Set.|||Percentage of participants|||Number
1448312|NCT00863655|Secondary|Overall Survival (OS) by Median|Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause.|up to 53 months|All randomized patients were included in the Full Analysis Set.|||Months||95% Confidence Interval|Median
1448313|NCT00863655|Secondary|Overall Survival (OS) by Number of Deaths|Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact.|up to 53 months|All randomized patients were included in the Full Analysis Set.|||Participants|||Number
1448314|NCT00863655|Primary|Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.|Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.|date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to about 19 months|All randomized patients were included in the Full Analysis Set.|||months||95% Confidence Interval|Median
1448315|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient’s recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.|||Percentage of Subjects|||Number
1448316|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose|The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.|Day 10|Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.|||Percentage of Subjects|||Number
1448317|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The delayed recall score provides a measure of the patient’s recent memory. The total score ranges from 0 (no memory) to 12 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.|||Percentage of Subjects|||Number
1448318|NCT00863551|Secondary|Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose|The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 ‘free recall’ learning trials, and reflects the patient’s ability to learn. The total score ranges from 0 (no memory) to 36 (best memory).|Day 10|Intent-to-treat, which included all patients who started the study.|||Percentage of Subjects|||Number
1448319|NCT00863551|Primary|Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5|Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.|Day 10, Hour 5|Intent-to-treat, which included all patients who started the study.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
1448320|NCT00863512|Primary|Overall Survival|Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.|Up to 12 years|Study terminated prematurely with 34 participants recruited. Per protocol, 338 events were needed to conduct the primary analysis; therefore, the planned analyses was not performed due to a lack of events and a termination of data collection.||||||
1448321|NCT00863434|Primary|Overall Survival||Every 3 months for 2 years, and then annually for 3 years||||months||Full Range|Median
1448326|NCT00863356|Primary|This Study Evaluates the Efficacy of HemCon Hemostatic Agent in Control of Complicated Epistaxis in Terms of % Success of Hemostasis. Success Will be Defined as Achieving Active Control of Bleeding Before Patient Leaves the Physicians Office.||Removal: 48 hours. Follow-up: 1 week.|||||||
1448327|NCT00863343|Primary|MSD Influenza B Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day||||participants|||Number
1448328|NCT00863343|Primary|MSD Influenza A Test Results Against Culture and PCR|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day||||participants|||Number
1448329|NCT00863343|Primary|MSD Influenza B Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.|1 day||||participants|||Number
1448330|NCT00863343|Primary|MSD Influenza A Test Results Against Cell Culture|A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.|1 day|per protocol|||participants|||Number
1448331|NCT00863330|Primary|Primary Objective|Determine the ability of autologous cells infused with minimal in vitro culture in conjunction with high dose interleukin -2 (IL-2) following non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma.|4-6 weeks after completion of TIL|Study was terminated for administrative reasons. complete data was not collected and no data analysis was completed||||||
1448332|NCT00863317|Primary|Duration of Cough||up to 4 weeks||||days||Inter-Quartile Range|Median
1448333|NCT00863265|Primary|LDL Cholesterol||At the end of week 3 on each diet|Healthy subjects|||mg/deciliter||95% Confidence Interval|Mean
1448334|NCT00863265|Primary|Percent Cholesterol Absorption|Percent of intestinal cholesterol absorbed. Intestinal cholesterol is comprised of dietary cholesterol intake and endogenous cholesterol secreted into the intestinal lumen. Cholesterol absorption is the percent of intestinal cholesterol that is taken back up into the body and excluded from fecal excretion. It is also referred to as the efficiency of intestinal cholesterol absorption.|Determined on the final 5 days of each dietary period||||Percent||95% Confidence Interval|Mean
1448335|NCT00863265|Primary|Cholesterol Excretion|Milligrams of fecal cholesterol and cholesterol metabolites excreted per day|At the end of week 3 on each diet|Healthy subjects|||mg per day||95% Confidence Interval|Mean
1448336|NCT00863109|Secondary|Percentage of Participants Who Were Compliant With Treatment According To Medication Count (Subset Analysis)|Compliance was calculated as the amount of dispensed medication minus the amount of medication returned by participants divided by amount of dispensed medication.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants; participants who had met the evaluation and eligibility criteria and were included in the study. Analysis Population included 53 participants who completed 48 weeks of treatment and 77 participants who did not complete 48 weeks of treatment (early end).|||percentage of participants|||Number
1448337|NCT00863109|Secondary|MCID in CLDQ-HCV Scores|The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status perceived by themselves). The MCID was calculated for each domain of the CLDQ-HCV and for the CLDQ-HCV summary score.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.|||score on a scale||Standard Deviation|Mean
1448338|NCT00863109|Secondary|Minimal Clinically Important Difference (MCID) in SF-36 Scores|SF-36 is a 36-item questionnaire measuring HRQL covering 2 summary measures, PCS and MCS. The SF-36 consists of 8 subscales. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst HRQL, 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status. MCID was defined as the difference in questionnaire scores between baseline and final visits for those participants who had stated that their health status had changed at the end of the study (improved in one category of health status as perceived by themselves). The MCID was calculated for each subscale of the SF-36 and for PCS and MCS.|From Baseline Visit to Final Visit (up to 72 weeks)|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had improved in one category of health status as perceived by themselves.|||score on a scale||Standard Deviation|Mean
1448348|NCT00863057|Secondary|Patient and Clinician Global Impression of Change (PGIC and CGIC) on a 7-point Likert Scale|"The GIC scale is a validated instrument that consists of seven verbal descriptors on a 7-point scale:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse~Participants were carefully instructed to consider the impact of study treatments on their level of neuropathic pain intensity during the baseline phase of the study."|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||participants|||Number
1448339|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in CLDQ-HCV Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|The CLDQ-HCV is a disease-specific questionnaire measuring quality of life that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).|||score on a scale||Standard Deviation|Mean
1448340|NCT00863109|Secondary|Change From Baseline to Week 72 (WK72) in SF-36 Scores Among Participants Who Completed Treatment and Participants Who Had Early End of Treatment (Subset Analysis)|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72. Analysis Population included 38 participants who completed 48 weeks of treatment and 8 participants who did not complete 48 weeks of treatment (early end).|||score on a scale||Standard Deviation|Mean
1448341|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in Chronic Liver Disease Questionnaire-Hepatitis C Virus (CLDQ-HCV)|The CLDQ-HCV is a disease-specific questionnaire measuring HRQL that contains 29 items divided into 4 domains: emotional function (9 items), worry (6 items), systemic symptoms (8 items) and activity/energy (6 items). All items refer to the previous 2 weeks and are rated on a 7 point Likert scale, with 1 corresponding to the maximum frequency (“all of the time”) and 7 to the minimum (“none of the time”). Domain scores are the means of the items contained. A summary score is calculated by the mean of all domain scores (CLDQ-HCV Global). Higher scores indicate better health-related quality of life.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had CLDQ-HCV data available at baseline and Week 72.|||score on a scale||Standard Deviation|Mean
1448342|NCT00863109|Primary|Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status.|Baseline, Week 72|All Evaluable Participants (participants who had met the evaluation and eligibility criteria and were included in the study) who had SF-36 data available at baseline and Week 72.|||score on a scale||Standard Deviation|Mean
1448343|NCT00863057|Other Pre-specified|Methadone Trough Level and Weekly Mean Pain Scores|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint.|During the fourth week of each treatment period|||||||
1448344|NCT00863057|Other Pre-specified|Sensory and Affective Qualities of Pain Measured by the McGill Pain Questionnaire - Short Form (MPQ-SF)|This was one of the exploratory objectives and was not analyzed as the study was terminated. We do not have any plan to analyze this endpoint in the future.|At the fourth treatment week of each treatment period|||||||
1448345|NCT00863057|Secondary|Number of Participants With Treatment-emergent Grade 2 to 4 Adverse Events|The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 was used (see the link to the grading table in Protocol Section)|From study entry to end of study at week 20 or premature study discontinuation|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Participants|||Count of Participants
1448346|NCT00863057|Secondary|Maximum Tolerated Dose of Duloxetine and Methadone||During each treatment period|The number below is the highest tolerated daily dose in mg based on n=12 for Methadone and n=10 for Duloxetine.|||mg|||Number
1448347|NCT00863057|Secondary|Use of Rescue Medication (Acetaminophen)||During each treatment period and the subsequent cross-over (or final study week) period|The analysis was per protocol. Because of a cross-over trial, the # of participants analyzed do not match with the flow chart. Any participant who took the rescue med during the study period (incl. cross-over period) was counted in this analysis. If a participant took the rescue med twice within the same period, the number is counted as one.|||participants|||Number
1448375|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.|Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
1448349|NCT00863057|Secondary|Emotional Functioning as Measured by the Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is a 20-item self-report rating inventory measuring characteristic attitudes and symptoms of depression. Participants were asked to score each item: (0) Rarely, (1) Occasionally, (2) Sometimes, and (3) Most of time. Some items are multiplied by -1 to change direction. The overall CES-D score is simply the sum of 20 items. The highest possible total CES-D score is 48, and the lowest possible score is -12. The total CES-D score is considered missing if more than 4 items are not answered.|At the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Standard Deviation|Mean
1448350|NCT00863057|Secondary|Quality of Life Measured by SF-36 Healthy Survey (SF-36)|The data for this outcome are not available for the analysis due to an issue with a company which provides software to calculate SF-36.|At the fourth treatment week of each treatment period|||||||
1448351|NCT00863057|Secondary|Pain-related Interference Measured by the Brief Pain Inventory (BPI) Interference Items|"The BPI interference scale measured level of interference with the following seven items:~General activity~Mood~Walking ability~Normal work~Relations with other people~Sleep~Enjoyment of life~Interference scales range from 0=’Does not interfere’ to 10=’Completely interferes’. The overall BPI score is the mean of seven item with the minimum and maximal scores of 0 and 70, respectively."|At the fourth week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Inter-Quartile Range|Median
1448352|NCT00863057|Secondary|Mean Nighttime Pain Measure on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average during the night time."|Over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Standard Error|Mean
1448353|NCT00863057|Secondary|Number of Participants With 50% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||participants|||Number
1448354|NCT00863057|Secondary|Number of Participants With 30% or More Improvement in Mean Pain Score on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine at baseline and over the fourth treatment week of each treatment period.~The % of improvement was calculated as (x-y)/x,where x was the MPI score at baseline, and y was the MPI score at the end of each treatment stage."|At Baseline and over the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||participants|||Number
1448355|NCT00863057|Primary|Weekly Mean Pain Score Derived From Self-reported Average Daily Pain Intensity on an 11-point Likert Scale|"Pain was measured on an 11-point Likert numerical rating scale, ranging from 0=``No pain to 10=``Pain as bad as you can imagine.~Participants were given pain diaries at weeks 0, 5, 10, and 15. They started the diary 7 days prior to their clinic visits at weeks 0, 4, 9, 14, and 19. During the 7 days, each morning, they recorded their pain level due to neuropathy by circling the number that best described their neuropathy pain on average over the past 24 hours."|During the fourth treatment week of each treatment period|The analysis was per protocol. Since this is a cross-over trial, the number of participants analyzed do not match with the ones in the flow chart.|||Scores on a scale||Standard Deviation|Mean
1448356|NCT00862979|Secondary|Reciprocal Creatinine Slope Between Month 6 and Month 18|Reciprocal Creatinine Slope is an indication of renal function over time with a higher slope value indicating an improvement in renal function.|Between Month 6 and Month 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||1/(μmol/L)/(hour)||Standard Deviation|Mean
1448357|NCT00862979|Secondary|Serum Creatinine at Month 6, 8, 9, 10 12 and 18|Serum Creatinine is an indicator of renal function measured in the blood|Month 6, 8, 9, 10 12 and 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||μmol/L||Standard Deviation|Mean
1448358|NCT00862979|Secondary|Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18|Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 12 and 18. For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)|Month 12 and 18|Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 12 & 18 were analyzed|||mL/min||Standard Deviation|Mean
1448359|NCT00862979|Secondary|Occurrence of Major Cardiac Events (MACE) From Month 6 to 18|Major cardiac events (MACE) was defined as one of the following: any death, myocardial infarction, coronary artery bypass grafting|Month 6 to Month 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||Occurences|||Number
1448360|NCT00862979|Secondary|Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18|Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.|Month 6 to Month 9; Month 9 to Month 18|Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable|||Occurences|||Number
1448361|NCT00862979|Primary|Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18|Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3*(C-1.154)*(A-0.203)*G*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.|Month 18|Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 18 were analyzed|||mL/min||Standard Deviation|Mean
1448362|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. MMSE: Brief, structured examination of mental status that assesses orientation, memory, attention, naming, comprehension, and praxis. The range is 0 to 30, with a lower score indicating a worse mental state|Baseline to 1 year|FAS, OC|||Scale scores||Standard Error|Least Squares Mean
1448363|NCT00862940|Secondary|Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score|Adjusted mean change from baseline on cognitive and behavioural scores. COWAT: Verbal fluency test. The patient was asked to, during 1 minute, generate as many words as possible beginning with three pre-specified letters. The total score was calculated as the sum of acceptable words generated, with higher scores indicating lower cognitive impairment|Baseline to 1 year|FAS, observed cases (OC)|||Scale scores||Standard Error|Least Squares Mean
1448364|NCT00862940|Secondary|Changes in Total Hippocampal Volume (HCV)|Estimated mean changes in total HCV|Baseline to 1 year|FAS-MRI|||mm^3/year||Standard Deviation|Mean
1448365|NCT00862940|Primary|Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)|Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52)|Baseline to 1 year|FAS-MRI: Full-analysis set for all patients in the all-patients-treated set (APTS) who had at least one valid MRI scan >=6 months after initiation of investigational medicinal product (IMP). The FAS (full analysis set, efficacy set) replaces the intention-to-treat (ITT) concept used in older terminology.|||mL/year||Standard Error|Mean
1448366|NCT00862849|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) Related to Study Drug|The number of TEAEs related to study drug (as determined by the Investigator) are summarized. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|first dose through 7 to 10 days after last dose|Participants who received at least one dose of study drug (insulin lispro, regular human insulin, or recombinant human hyaluronidase [rHuPH20]).|||events|||Number
1448367|NCT00862849|Secondary|Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and every 30 mins (from 90 to 240 mins) after each injection. Percentage of total glucose infused from 0 to 4 hours is summarized.|predose up to 240 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.|||percentage of total glucose infused||Standard Deviation|Mean
1448368|NCT00862849|Secondary|Time to Percentage of Total Glucose Infused|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection. Time to 25%, 50%, and 75% of total glucose infused are summarized.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable glucose infusion data.|||minutes||Standard Deviation|Mean
1448369|NCT00862849|Secondary|Peak Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable Cmax data.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
1448370|NCT00862849|Secondary|Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.|predose up to 480 minutes postdose|Participants who completed all study visits and had evaluable t(50%max) data.|||minutes||Standard Deviation|Mean
1448371|NCT00862849|Primary|Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])|Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.|predose up to 30 minutes postdose|Participants who completed all study visits and had evaluable %AUC(0-t) data.|||percentage of coefficient of variance||Standard Deviation|Mean
1448372|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.|Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
1448373|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.|Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
1448374|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.|Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
1448376|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.|Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
1448377|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).|Median overall survival (OS)|From date of registration (Informed Consent Form completed) until the date of death.||||Months||95% Confidence Interval|Median
1448378|NCT00862836|Secondary|Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).|Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.|From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.||||Months||95% Confidence Interval|Median
1448379|NCT00862836|Primary|Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).|Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)|From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.||||Participants|||Number
1448380|NCT00862823|Primary|Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz|The maximum concentration for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1448381|NCT00862823|Primary|Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz|The area under the concentration time curve for tenofovir, emtricitabine and efavirenz|17 days|US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsdGeneral Considerations. Rockville, MD: United States Food and Drug Administration Center for Drug Evaluation and Research.|||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1448382|NCT00862810|Primary|Pain Following HPV Vaccine|"Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.~The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain."|10 minutes following vaccination||||participants|||Number
1448383|NCT00862784|Secondary|Serum Anti-IMC-1121B (Immunogenicity) at Day 1|Data presented are the number of participants with treatment emergent anti-IMC-112B antibodies.|Day 1 (Cycles 1, 5, 9, and 30-day follow-up)|All participants who received any amount of study drug and had serum Anti-IMC-1121B (ramucirumab) evaluated.|||participants|||Number
1448384|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448385|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448386|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448387|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448388|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycles 5, 9, 13, 17, and 21|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline and 1 hour post infusion on Day 1 (Cycles 5, 9, 13, 17, and 21)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448389|NCT00862784|Secondary|Steady State Volume of Distribution (Vss) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Vss was not calculated.|Baseline, 1, 168, and 336 hours post infusion Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448390|NCT00862784|Secondary|Clearance (CL) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, CL was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448391|NCT00862784|Secondary|Half-Life (t1/2) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, t1/2 was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448392|NCT00862784|Secondary|Area Under the Concentration (AUC) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, AUC was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448393|NCT00862784|Secondary|Maximum Concentration (Cmax) at Day 1 of Cycle 1|Due to sparse pharmacokinetic schedule, Cmax was not calculated.|Baseline, 1, 168, and 336 hours post infusion on Day 1 (Cycle 1)|No participants were analyzed due to sparse pharmacokinetic schedule.||||||
1448394|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Severe Adverse Events (SAEs)|Data presented are the number of participants who experienced SAEs, adverse events (AEs) resulting in death and AEs leading to discontinuation of treatment, that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received any amount of study drug.|||participants|||Number
1448395|NCT00862784|Secondary|Number of Participants With IMC-1121B (Ramucirumab)-Related Adverse Events (AEs)|Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), that were considered to be related to IMC-1121B (ramucirumab) by the investigators. A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|First dose to 25.2 months|All participants who received at any amount of study drug.|||participants|||Number
1448396|NCT00862784|Secondary|Duration of Response|The duration of response was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion.|Time of response to time of measured progressive disease up to 22.2 months|All participants who received any amount of study drug who had CR and PR.|||months||95% Confidence Interval|Median
1448397|NCT00862784|Secondary|Overall Survival (OS)|OS was defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, OS was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 18.|||months||95% Confidence Interval|Median
1448398|NCT00862784|Secondary|Percentage of Participants With Complete Response or Partial Response [Objective Response Rate (ORR)]|ORR is the percentage of participants with a confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease up to 23.8 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1448399|NCT00862784|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 28.1 months|All participants who received any amount of study drug. The number of participants censored was 11.|||months||95% Confidence Interval|Median
1448400|NCT00862745|Primary|Change in Frequency of Urge Urinary Incontinence Episodes at Week 12.||Baseline and Week 12|The population analyzed included all participants receiving at least 1 dose of study intervention.|||episodes||Standard Deviation|Mean
1448401|NCT00862719|Secondary|Treatment Related Adverse Events Grade 3 or Higher for Non-hematological Toxicity|Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.|Transplant (Day 0) up to 3 years|All patients enrolled and received treatment.|||participants|||Number
1448402|NCT00862719|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment who achieved platelet recovery/engraftment of platelets.|||days||95% Confidence Interval|Median
1448403|NCT00862719|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided. For the RCD group, all patients engrafted before day +30, except one patient who died at day 28 before engraftment. For the PD group, all patients engrafted before day +100, except one patient who died on day +103 before engraftment. For the 600 mg sitagliptin/12 hours group, two patients engrafted before day +100, and the other two patients died before day +100 before engraftment. The one patient on 600 mg sitagliptin/8 hours died on day +14 before engraftment.|Transplant (Day 0) up to 1 year|All patients enrolled and received treatment.|||days||95% Confidence Interval|Median
1448404|NCT00862719|Primary|Cumulative Incidence of Patients With Engraftment by Day +30 Following Transplant|Evaluate the efficacy of CD26/DPP-IV inhibition in increasing the cumulative incidence of adult patients with hematological malignancies engrafting by day +30 following transplantation of UCB by 30 percent. The cumulative incidence of patients achieving this will be reported. The value of the estimate will be from bootstrapping 1000 samples with replacement of the data and the 95% confidence interval will be calculated using the percentile method.|Transplant (Day 0) through Day +30|Modified Intent to treat population (mITT) - all patients receiving at least one dose of study drug and receiving REB depleted UCB units only|||percentage of participants||95% Confidence Interval|Number
1448405|NCT00862654|Primary|Total Severity Score (TSS): Percent Change From Baseline at Week 4|Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.|baseline and week 4|Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)|||Percent change||Full Range|Median
1448453|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448406|NCT00862641|Secondary|Percentage of Selected Respiratory Adverse Events|"The selected respiratory Adverse Events are dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea and wheezing.~Subjects may have reported more than one type of Adverse Event."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Percentage of Subjects|||Number
1448407|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Oxygen Saturation Measured by Pulse Oximetry|Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement.|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.|||Percentage of Oxygen Saturation||Standard Deviation|Mean
1448408|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1/ FVC Ratio|"FEV1 and FVC data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|"The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as N."|||Percentage of FEV1 / FVC||Standard Deviation|Mean
1448409|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for Forced Vital Capacity (FVC)|"FVC data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.|||Liters||Standard Deviation|Mean
1448410|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Percent Predicted|"FEV1 data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each row is noted in the category titles, as “N”.|||Percentage of Predicted FEV1||Standard Deviation|Mean
1448411|NCT00862641|Secondary|Change From Baseline to the 2 Hour Post-dose Assessment for FEV1 Absolute Values|"FEV1 data was obtained by spirometry measurements.~Change from Baseline is calculated as the Hour 2 measurement minus the Baseline measurement."|Baseline and Hour 2|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug. The number of participants included in the calculation for each time point is noted in the category titles, as “N”.|||Liters||Standard Deviation|Mean
1448412|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).~Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.~The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 24 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Subjects|||Number
1448413|NCT00862641|Secondary|Use of Short-acting Bronchodilators for Treatment of Symptoms After Study Drug Administration|"The data represents the numbers of subjects using short acting bronchodilators at time of selected Adverse Event (AE).~Short acting bronchodilators are defined as medications coded to drugs for obstructive airway disease.~The selected respiratory symptomatic AEs included the following preferred terms: dyspnoea, dyspnoea exertional, obstructive airways disorder, tachypnoea, & wheezing."|Within 2 Hours of study drug administration|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Subjects|||Number
1448414|NCT00862641|Primary|Percentage of Subjects Who Had a >15% Decrease in Forced Expiratory Volume in 1 Second (FEV1) at the 2-hour Postbaseline Assessment|FEV1 data was obtained by spirometry measures.|2 Hours post dose|The number of participants analyzed per arm represents Safety Analysis Set (SAF) which included all randomized subjects who received any amount of study drug.|||Percentage of Subjects|||Number
1448415|NCT00862563|Secondary|Wechsler Memory Scale-3rd Ed. Spatial Span|WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||units on a scale||Standard Error|Mean
1448416|NCT00862563|Secondary|Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total|WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task.|Baseline, Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||units on a scale||Standard Error|Mean
1448417|NCT00862563|Secondary|COWAT-Category|Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced.|Baseline, Week12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||Number of Words Produced||Standard Error|Mean
1448418|NCT00862563|Secondary|Controlled Word Association Test (COWAT)- Letter Fluency|Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown.|Baseline & Week 12|Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available.|||Number of Words Produced||Standard Error|Mean
1448692|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 1|Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg|week 1|Full analysis set, imputation method used was last observation carried forward (LOCF).|||participants|||Number
1448419|NCT00862563|Secondary|Percent Days Drinking|Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.|||Percentage of Days/ Week||Standard Error|Mean
1448420|NCT00862563|Secondary|Mean Percent Days Heavy Drinking|Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men.|Weeks 10, 11, 12|Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the time frame for the specific analyses, i.e. Weeks 10,11,12.|||Percentage of Days/Week||Standard Error|Mean
1448421|NCT00862563|Secondary|AB-Neurotoxicity Scale.|Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|Week 12|Alcohol dependent subjects.|||Scale Scores||Standard Error|Mean
1448422|NCT00862563|Primary|The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties.|Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor.|Weeks 10, 11, 12|Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12.|||Standard Drinks per day||Standard Error|Mean
1448423|NCT00862537|Primary|Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months|The Parkinson’s Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson’s Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).|baseline and 11 months||||scores on a scale||Standard Deviation|Mean
1448424|NCT00862459|Secondary|Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter|CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding subjects who had no lesion detected, and those who had no value determined)|||CNR||Standard Deviation|Mean
1448425|NCT00862459|Secondary|Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group|The blinded readers gave an estimation of the tumor grade of brain tumors (low grade [I or II] or high grade [III or IV]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results|up to 2 hours after the injection of study medication|PPS participants with tumors|||Percentage of accuracy|||Number
1448426|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448427|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448428|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448429|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448430|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448431|NCT00862459|Secondary|Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader|The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448432|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) – Independent Radiologist|The independent radiologist determined the PF for each lesion|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||seconds||Standard Deviation|Mean
1448433|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) – Independent Radiologist|The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||seconds||Standard Deviation|Mean
1448434|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) – Independent Radiologist|The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||seconds||Standard Deviation|Mean
1448435|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) – Independent Radiologist|The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||mL / 100 g tissue / min.||Standard Deviation|Mean
1448436|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) – Independent Radiologist|The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||mL / 100 g tissue||Standard Deviation|Mean
1448437|NCT00862459|Secondary|Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) – Independent Radiologist|The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.|up to 2 hours after the injection of study medication|PPS (excluding subjects whose parameter map value was not determined)|||mL / 100 g tissue||Standard Deviation|Mean
1448438|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448439|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448440|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Permeability Factor (PF) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448441|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448442|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448443|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448444|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS|||percentage of participants|||Number
1448445|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448446|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Time to Peak (TTP)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448447|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448448|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448449|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448450|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 3|BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448451|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448452|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448454|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) – Blinded Reader 2|BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS. Due to rounding, the sum of percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448455|NCT00862459|Secondary|Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) – Blinded Reader 1|BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448456|NCT00862459|Secondary|Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI|The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.|up to 2 hours after the injection of study medication|PPS, Due to rounding, the sum of the percentages may range from 99.9 to 100.1.|||percentage of participants|||Number
1448457|NCT00862459|Secondary|Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI|The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.|up to 2 hours after the injection of study medication|PPS|||percentage of exact matches|||Number
1448458|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS(excluding subjects with no enhanced lesion detected)|||percentage of lesions|||Number
1448459|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)|||percentage of lesions|||Number
1448460|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Enhanced Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1|up to 2 hours after the injection of study medication|PPS (excluding subjects with no enhanced lesion detected)|||percentage of lesions|||Number
1448461|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 3|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||percentage of lesions|||Number
1448462|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 2|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||percentage of lesions|||Number
1448463|NCT00862459|Secondary|Accuracy Comparison of Gadobutrol Doses – Detection of Matched Lesions: Blinded Reader 1|The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||percentage of lesions|||Number
1448464|NCT00862459|Primary|Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI|CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.|up to 2 hours after the injection of study medication|PPS (excluding participants with insufficient images)|||CNR||Standard Deviation|Mean
1448465|NCT00862459|Primary|Assessment of Internal Morphology|The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||scores on a scale||Standard Deviation|Mean
1448466|NCT00862459|Primary|Assessment of Border Delineation|The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||scores on a scale||Standard Deviation|Mean
1448467|NCT00862459|Primary|Assessment of Lesion Contrast Enhancement|The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.|up to 2 hours after the injection of study medication|PPS (excluding subjects with no lesion detected)|||scores on a scale||Standard Deviation|Mean
1448468|NCT00862459|Primary|Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.|Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.|up to 2 hours after the injection of study medication|PPS (excluding one participant with insufficient images)|||Lesions per participant||Standard Deviation|Mean
1448713|NCT00860158|Secondary|To Estimate Progression Free Survival||18 months|||||||
1448469|NCT00862459|Primary|Categorical Visualization Score (CVS)|The primary visualization variables (number [no.] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)–(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.|up to 2 hours after the injection of study medication|The per protocol set (PPS), which included all participants with valid images who received +/-10% of the intended dose of study drug and had no major protocol or Magnetic Resonance Imaging (MRI) procedure deviations (excluding one participant with insufficient images)|||Scores on a scale||Standard Deviation|Mean
1448470|NCT00862277|Primary|Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1448471|NCT00862277|Primary|Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment||Day 0|Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1448472|NCT00862251|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448473|NCT00862251|Secondary|Percent Change From Baseline in Apo B/Apo A-I Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448474|NCT00862251|Secondary|Percent Change From Baseline Apolipoprotein A-I (Apo A-I)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448475|NCT00862251|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448476|NCT00862251|Secondary|Percent Change From Baseline in Non-HDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1448477|NCT00862251|Secondary|Percent Change From Baseline in TC/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448478|NCT00862251|Secondary|Percent Change From Baseline in LDL-C/HDL-C Ratio||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448479|NCT00862251|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448480|NCT00862251|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1448481|NCT00862251|Secondary|Percent Change From Baseline in Triglycerides||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448482|NCT00862251|Secondary|Percent Change From Baseline in Total Cholesterol (TC)||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent Change||95% Confidence Interval|Least Squares Mean
1448483|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg|||participants|||Number
1448484|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg|||participants|||Number
1448485|NCT00862251|Secondary|Number of Participants Who Reached the Target LDL-Cholesterol Level of < 70 mg/dL (1.81 mmol/L)||Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||participants|||Number
1448486|NCT00862251|Secondary|Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Switching Treatment to Rosuvastatin||Baseline and Week 6|Efficacy data were analyzed primarily based upon the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448487|NCT00862251|Secondary|In Participants Treated With Atorvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Atorvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with atorvastatin 10 mg and were switched to either Ezetimibe/simvastatin or had atorvastatin dose doubled to 20 mg|||Percent change||95% Confidence Interval|Least Squares Mean
1448488|NCT00862251|Secondary|In Participants Treated With Simvastatin at Baseline, Percent Change From Baseline in LDL-C After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Simvastatin||Baseline and Week 6|Analysis performed on subpopulation of participants who were previously treated with simvastatin 20 mg and were switched to either Ezetimibe/simvastatin or had simvastatin dose doubled to 40 mg|||Percent change||95% Confidence Interval|Least Squares Mean
1448489|NCT00862251|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin).||Baseline and Week 6|Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
1448490|NCT00862186|Primary|Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness.|The FS-A is a 14-item self-report instrument which measures on a 5 point scale ranging from ‘1 - not at all’ to ‘5 - all the time’ the extent to which each of 14 statements describes how the respondent has been feeling during the past 7 days (Hinds et al., 2007). The potential score range is 14-70; higher scores represent greater fatigue (Hinds et al., 2007). The scores (1 through 5) on the Likert-type scales for resource use and resource helpfulness were determined at each post baseline time point, as were change from baseline values for the FS-A. All FS-A change from baseline values, per Resource Use or Resource Helpfulness Categorization, were combined regardless of post-baseline time point.|baseline and weekly up to 8 weeks||||units on a scale||Full Range|Median
1448491|NCT00862134|Secondary|Positive Aldo-keto Reductase 1C3 (AKR1C3) Expression in Participating Patients|"AKR1C3 was evaluated on a semi-quantitative scale, and the percentage of cells staining at each of the following four levels was recorded: 0 (unstained), 1+ (weak staining), 2+ (moderate staining) and 3+ (strong staining).~Patients with a strong staining score (3+) were considered to be AKR1C3 positive"|Within 1 year of enrollment||||participants|||Number
1448492|NCT00862134|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following last administration of study treatment||||participants|||Number
1448493|NCT00862134|Primary|Number of Participants That Achieved a Response (Complete or Partial) After Receiving PR104/Docetaxel Versus Docetaxel Alone|Defined as the number of subjects with complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) criteria|Participants were followed for the duration on study, an average of 4 months||||participants|||Number
1448494|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance|A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.|At Week 10, end of treatment|Safety Analysis Set (OC). Descriptive statistics only.|||mL/min||Standard Deviation|Mean
1448495|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)|The WPAI_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.|||WPAI_CD Item 5 score||Standard Deviation|Mean
1448496|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score|The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL).|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.|||IBDQ score||Standard Deviation|Mean
1448497|NCT00862121|Secondary|Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)|Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.|Within the 10 week treatment period|Full Analysis Set (OC). Descriptive statistics only.|||mg/L||Standard Deviation|Mean
1448498|NCT00862121|Secondary|Relative Change From Baseline to Week 10 in Fecal Calprotectin|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.|At Week 10, end of treatment|Full Analysis Set (FAS), observed cases (OC), descriptive statistics only.|||microgram/gram faeces||Standard Deviation|Mean
1448499|NCT00862121|Primary|Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.|The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70.|At Week 10, end of treatment|The percentage of CDAI responders at Week 10 was analysed for the FAS (treated participants with post-baseline CDAI), Last Observation Carried Forward (LOCF).|||percentage of participants|||Number
1448500|NCT00862082|Secondary|Pharmacokinetics (AUC) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng.h/ml||Standard Deviation|Mean
1448501|NCT00862082|Secondary|Pharmacokinetics (T1/2) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||hr||Standard Deviation|Mean
1448502|NCT00862082|Secondary|Pharmacokinetics (Cmax) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng/ml||Standard Deviation|Mean
1448714|NCT00860158|Secondary|To Estimate PSA Response Rate||18 months|Data for this secondary objective was not collected or analyzed.||||||
1448503|NCT00862082|Secondary|Pharmacokinetics [Area Under the Curve(AUC)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng.h/ml||Standard Deviation|Mean
1448504|NCT00862082|Secondary|Pharmacokinetics [Half Life (T1/2)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in PK sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||hr||Standard Deviation|Mean
1448505|NCT00862082|Secondary|Pharmacokinetics [Maximum Plasma Concentration (Cmax)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)||Day 1 of Cycles 1 and 2|Participation in pharmacokinetic (PK) sampling was optional to subjects, therefore not all subjects in the study were analyzed.|||ng/ml||Standard Deviation|Mean
1448506|NCT00862082|Secondary|Safety and Tolerability: Serious Adverse Events|The number of participants with at least one Serious Adverse Event was measured.|30 days following the last administration of study treatment||||participants|||Number
1448507|NCT00862082|Primary|Maximum Tolerated Dose (MTD) of PR104 When Used in Combination With Standard Dose Sorafenib in the Phase I Population||4 weeks (1 cycle)||||mg/m2|||Number
1448508|NCT00861913|Secondary|Duration of Response|The date at which the objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented, assessed up to 5 years.|From time of documented response to the date progression is documented, assessed up to 5 years.|There was one response and therefore median duration of response was not analyzed.||||||
1448509|NCT00861913|Secondary|Progression Free Survival|Progression free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.|From registration to documentation of disease progression, assessed up to 5 years||||months||95% Confidence Interval|Median
1448510|NCT00861913|Secondary|Overall Survival|Overall survival time is defined as the time from registration to the time of death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
1448511|NCT00861913|Primary|Toxicity|Toxicity is defined as any grade 3 or higher adverse event as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and at least possibly related to treatment. The maximum grade for each type of toxicity will be recorded for each patient. We report the number of patients experiencing a grade 3 or higher adverse event at least possibly related to treatment.|Up to 5 years||||participants|||Number
1448512|NCT00861913|Primary|Tumor Response Rate|"Tumor response rate is defined as the number of eligible patients whose disease status meets the Response Evaluation Criteria In Solid Tumors (RECIST) criteria for compete response (CR) or partial response (PR) divided by the number of evaluable patients. A ninety percent confidence interval for the true response proportion will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution and using the Duffy-Santner approach.~Complete Response (CR): Disappearance of all target lesions.~Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 5 years||||percentage of patients||90% Confidence Interval|Number
1448513|NCT00861757|Secondary|Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||beats per minute (bpm)||Standard Deviation|Mean
1448514|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Standing) at 12 Weeks||baseline, 12 weeks|All efficacy analyses were performed on an intent-to-treat (ITT) basis. The primary analysis population for efficacy was the Full Analysis Set (FAS) which included all subjects who were randomized and started study medication.|||mm Hg||Standard Deviation|Mean
1448515|NCT00861757|Secondary|Change From Baseline in Blood Pressure (Sitting) at 12 Weeks||baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||mm Hg||Standard Deviation|Mean
1448516|NCT00861757|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks|The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||milliliter (mL)||Standard Deviation|Mean
1448517|NCT00861757|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks|Nanograms of PSA per milliliter (ng/mL) of blood.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||microgram/Liter||Standard Deviation|Mean
1448518|NCT00861757|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12|The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||participants|||Number
1448519|NCT00861757|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12|The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||Participants|||Number
1448568|NCT00861705|Secondary|Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.|Assessed by physician observation.|at definitive surgery, up to 28 weeks||||percentage of participants with event||95% Confidence Interval|Number
1448520|NCT00861757|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks|"Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||milliliter per second (mL/sec)||Standard Error|Least Squares Mean
1448521|NCT00861757|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||units on a scale||Standard Error|Least Squares Mean
1448522|NCT00861757|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks|"Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).~Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||units on a scale||Standard Error|Least Squares Mean
1448523|NCT00861757|Secondary|Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||units on a scale||Standard Error|Least Squares Mean
1448524|NCT00861757|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks|"The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.~Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value."|baseline, 12 weeks|The primary analysis population for efficacy included all subjects who were randomized and started study medication. All efficacy analyses were performed on an intent-to-treat (ITT) basis.|||Units on a scale||Standard Error|Least Squares Mean
1448525|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448526|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (PPD ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||EU/mL||95% Confidence Interval|Geometric Mean
1448527|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)|Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448528|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)|Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||EU/mL||95% Confidence Interval|Geometric Mean
1448529|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448715|NCT00860158|Secondary|To Estimate Partial Pathologic Responses (pPR)||18 months|||||||
1448530|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody concentrations are expressed as Geometric Mean Titer (GMT).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Titer||95% Confidence Interval|Geometric Mean
1448531|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448532|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Unenhanced PRN)|Antibody titers were expressed as Geometric Mean Titer (GMT).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Titer||95% Confidence Interval|Geometric Mean
1448533|NCT00861744|Secondary|Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.||From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
1448534|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.|From Day 180 to Day 730 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
1448535|NCT00861744|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
1448536|NCT00861744|Secondary|Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).|NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Day 180 after vaccination|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
1448537|NCT00861744|Secondary|Number of Subjects With Solicited General Symptoms.|Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.|During the 15-day (Days 0-14) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
1448538|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.|Swelling with accompanying general symptoms|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
1448539|NCT00861744|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
1448540|NCT00861744|Secondary|Number of Subjects Reporting Medically Attended Visit (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subjects|||Number
1448541|NCT00861744|Secondary|Number of Subjects With Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling.|During the 4-day (Days 0-3) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
1448542|NCT00861744|Secondary|Number of Subjects Reporting Fever.|fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.|During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
1448543|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||IU/mL||95% Confidence Interval|Geometric Mean
1448544|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||IU/mL||95% Confidence Interval|Geometric Mean
1448545|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448546|NCT00861744|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448547|NCT00861744|Secondary|Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448548|NCT00861744|Secondary|Number of Subjects Reporting Other Rash.|Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
1448549|NCT00861744|Secondary|Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))|Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Titers||95% Confidence Interval|Geometric Mean
1448550|NCT00861744|Secondary|Number of Subjects Reporting Febrile Convulsions|Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.|During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
1448551|NCT00861744|Secondary|Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.||During the 43-day (Days 0-42) post-vaccination period|The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.|||Subjects|||Number
1448552|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||mIU/mL||95% Confidence Interval|Geometric Mean
1448553|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||mIU/mL||95% Confidence Interval|Geometric Mean
1448554|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 2 years post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448569|NCT00861705|Secondary|Time to First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause|From study entry to first event.|up to 10 years||2018-10-31|10/2018||||
1448716|NCT00860158|Primary|To Estimate the Pathologic Complete Response (pCR) Rate||18 months|No participants were analyzed for pCR due to study termination||||||
1448555|NCT00861744|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).|At 1 year post-vaccination|The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.|||Subjects|||Number
1448556|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 0 before vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||µg/mL||95% Confidence Interval|Geometric Mean
1448557|NCT00861744|Secondary|Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
1448558|NCT00861744|Secondary|Anti-hepatitis A Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Havrix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1448559|NCT00861744|Secondary|Anti-varicella Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1448560|NCT00861744|Secondary|Anti-S. Pneumoniae Antibody Concentrations (by Serotype).|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.|At Day 42 after vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||µg/mL||95% Confidence Interval|Geometric Mean
1448561|NCT00861744|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||IU/mL||95% Confidence Interval|Geometric Mean
1448562|NCT00861744|Secondary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Titers||95% Confidence Interval|Geometric Mean
1448563|NCT00861744|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1448564|NCT00861744|Secondary|Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.|Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).|At Day 42 after administration of a dose of Varivax vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
1448565|NCT00861744|Primary|Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.|Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
1448566|NCT00861744|Primary|Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.|Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
1448567|NCT00861744|Primary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.|Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.|At Day 42 after administration of a dose of Priorix vaccine.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.|||Subjects|||Number
1448766|NCT00859638|Secondary|Primary Care Resources and Supports||4 months|||||||
1448767|NCT00859638|Secondary|Patient Assessment of Chronic Illness Care||4 months|||||||
1448570|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).|||percentage of participants with pCR||95% Confidence Interval|Number
1448571|NCT00861705|Secondary|Recurrence-free Survival|From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause.|up to 10 years||2018-10-31|10/2018||||
1448572|NCT00861705|Secondary|Overall Survival|From study entry to death due to any cause|up to 10 years||2018-10-31|10/2018||||
1448573|NCT00861705|Secondary|Clinical Response Assessed by Tumor Measurement|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|Baseline; at completion of neoadjuvant therapy||2018-10-31|10/2018||||
1448574|NCT00861705|Secondary|Radiographic Response Assessed by Tumor Measurement|Assessed by RECIST|Baseline; at completion of neoadjuvant therapy||2018-10-31|10/2018||||
1448575|NCT00861705|Secondary|Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)||at definitive surgery, up to 28 weeks||2018-10-31|10/2018||||
1448576|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain bevacizumab (arms 2&4) versus not (arms 1&3).|At the time of definitive surgical removal, up to 28 weeks||||percentage of participants with pCR||95% Confidence Interval|Number
1448577|NCT00861705|Secondary|Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).|Comparing regimens that contain carboplatin (arms 3&4) versus not (arms 1&2).|At the time of definitive surgical removal, up to 28 weeks||||percentage of participants with pCR||95% Confidence Interval|Number
1448578|NCT00861705|Primary|Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).|Assessment of the difference in percentage of participants with pCR in the breast between regimens that contain carboplatin (arms 3&4) versus not (arms 1&2) will use a one-sided chi square test. 95% confidence intervals around the incidence of pCR will also be constructed using exact binomial methods.|At the time of definitive surgical removal, up to 28 weeks|All patients who began protocol neoadjuvant therapy and are assessable for pCR endpoint (N=433).|||percentage of participants with pCR||95% Confidence Interval|Number
1448579|NCT00861692|Primary|Number of Patients With Platelet Count Recovery|Platelet increase of ≥ 100G/L or 50%.|Day 3|Data are missing in 3 patients.|||participants|||Number
1448580|NCT00861692|Primary|Number of Patients With Major or Minor Bleeding|"Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial.~Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding."|During and 30 days after argatroban treatment||||participants|||Number
1448581|NCT00861692|Primary|Number of Patients With Unplanned Amputation||During and 30 days after argatroban treatment||||participants|||Number
1448582|NCT00861692|Primary|Number of Patients With Thrombosis (New and Extended)||During and 30 days after argatroban treatment||||participants|||Number
1448583|NCT00861692|Primary|Death Related to Heparin-induced Thrombocytopenia (HIT)||During and 30 days after argatroban treatment||||participants|||Number
1448584|NCT00861692|Primary|All-cause Death||During and 30 days after argatroban treatment||||participants|||Number
1448585|NCT00861692|Primary|Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation||During and 30 days after argatroban treatment||||participants|||Number
1448586|NCT00861614|Secondary|Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade renal function as measured by creatinine analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr).Gr 0: within normal range. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
1448587|NCT00861614|Secondary|Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade serum chemistry as measured by lipase and amylase analysis. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for lipase: Gr1: > 1.0 - 1.5 * ULN; Gr2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0*ULN. Abnormal values for amylase: Gr1: > 1.0 - 1.5 * ULN; Gr 2: > 1.5 - 2.0 * ULN; Gr 3: > 2.0 - 5.0 * ULN; Gr4: > 5.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
1448588|NCT00861614|Secondary|Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade liver function as measured by alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and alkaline phosphatase (ALP). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
1448599|NCT00861614|Primary|Overall Survival (OS)|OS is defined as the time in months from randomization date to date of death due to any cause in all randomized subjects. For participants alive at the time of the database cutoff date, OS was censored at the last date the participant was known to be alive.|Date of randomization to date of death|All randomized participants|||months||95% Confidence Interval|Median
1448589|NCT00861614|Secondary|Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline|Comparison of baseline versus worst grade hematology laboratory tests as measured by white blood count (WBC), absolute neutrophil count (ANC), platelet count, hemoglobin and lymphocyte results. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Gr 0: within normal range. Abnormal values for WBC were based on Gr 1: 3.0 - < Lower Limit of Normal (LLN); Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0. Abnormal values for Hemoglobin were based on Gr 1: 10.0 - < LLN; Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for ANC were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < LLN; Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0.|Day 1 to 70 days after last dose of study drug|All treated participants|||participants|||Number
1448590|NCT00861614|Secondary|Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0|"Time between the date of onset of an imAR to the date of resolution date of the event or the last known date participant was alive if an event did not resolve.~Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to 70 days after last dose of study drug|All treated participants receiving Ipilimumab + Radiotherapy|||weeks||Full Range|Median
1448591|NCT00861614|Secondary|Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR)|"The time between first dose of study drug and date of earliest Grade 3 or 4 imAR. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies and graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0.~Only the Ipilimumab + Radiotherapy group of participants was included in the analysis because ipilimumab is associated with inflammatory events resulting from increased or excessive immune activity likely to be related to its mechanism of action."|Day 1 to time of onset of the imAR of interest|All treated participants receiving Ipilimumab + Radiotherapy|||weeks||Full Range|Median
1448592|NCT00861614|Secondary|Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE)|Time between the date of onset of a Grade 3 or 4 irAE and the date of improvement to Grade 1 or less or the worst grade at baseline.|Day 1 to 70 days after last dose of study drug|All treated participants|||weeks||95% Confidence Interval|Median
1448593|NCT00861614|Secondary|Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE)|The time between first dose of study drug and date of earliest Grade 3 or 4 irAE. These irAEs are AEs of unknown etiology, consistent with an immune phenomenon and considered as causally related to drug exposure. The five subcategories of irAE examined include gastrointestinal (GI), liver, skin, endocrine, and neurological and are graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.|Day 1 to 70 days after last dose of study drug|All treated participants|||weeks||95% Confidence Interval|Median
1448594|NCT00861614|Secondary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug and grouped into gastrointestinal (GI), hepatic, skin, endocrine and neurological. ImARs were collected prospectively and grouped into enterocolitis, hepatitis, dermatitis, neuropathies and endocrinopathies. IrAEs/ imARs were graded using Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Ver. 3.0."|Randomization to date of death|All treated participants|||participants|||Number
1448595|NCT00861614|Secondary|Duration of Pain Response|The time between the initial date of pain response and completion date of pain response. The initial date when the pain response criterion was achieved was considered the pain response date. The earlier of date of death, date of tumor resection surgery, or date when pain response criterion was no longer met was considered the completion date of the pain response. If none of these scenarios occurred, the completion of the pain response was set to the last known alive date.|Day of initial pain response to day of completion of pain response or date of death|All pain-evaluable participants with pain response|||months||95% Confidence Interval|Median
1448596|NCT00861614|Secondary|Pain Response|The percentage of participants with a pain response assessed using the Brief Pain Inventory Short Form (BPI-SF) completed by participants throughout the study in a daily diary log. Pain-evaluable participants were defined as those with a decrease in the average daily worst pain intensity by at least 30% from baseline, maintained over 2 consecutive evaluations without the use of any rescue analgesic medication or increase in analgesic use in the same time period.|Assessed at screening, weeks 12, 18, 24, and at the end of treatment visit|All pain-evaluable participants|||percentage of participants||95% Confidence Interval|Number
1448597|NCT00861614|Secondary|Progression Free Survival (PFS)|All PFS events were based on investigator’s assessment. Participants who were alive and did not experience a PFS event were censored at the earlier of the latest prostate-specific antigen (PSA) or radiological tumor assessment date. Participants who did not die, showed no clinical deterioration, and who had no recorded post-baseline PSA or radiological tumor assessment were censored at randomization date.|Date of randomization to earliest date of confirmed PSA or radiological progression, clinical deterioration or death|All randomized participants|||months||95% Confidence Interval|Median
1448598|NCT00861614|Primary|Overall Survival Rate|The overall survival (OS) rate is a percentage, representing the fraction of all randomized participants who were alive following treatment, from 1 to 5 years. OS was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Date of randomization to date of death|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1448768|NCT00859638|Secondary|Two Minute Walk Test||4 months|||||||
1448769|NCT00859638|Secondary|Grip Strength||4 months|||||||
1448600|NCT00861601|Secondary|Log-transformed AUC(0-t) and AUC(0-24) on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. AUC(0-t)=area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration, and AUC(0-24)=area under the concentration-time curve from 0 (pre-dose) to 24 hours.|Day 14, Day 15|PK Parameter Population|||hours * ng/ml||95% Confidence Interval|Geometric Mean
1448601|NCT00861601|Secondary|Log-transformed Tmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Tmax=maximum drug concentration time.|Day 14, Day 15|PK Parameter Population|||hours||95% Confidence Interval|Geometric Mean
1448602|NCT00861601|Secondary|Log-transformed Cmax on Days 14 and 15 in Participants Receiving Eltrombopag 12.5 mg|Serial PK samples were collected over a 24-hour (h) period on Days 14 and 15 in participants receiving eltrombopag 12.5 mg. A total of 8 blood samples (3 milliliters per sample) were collected at pre-dose, and at 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, and 24 h post-dose. Cmax=maximum drug concentration.|Day 14, Day 15|PK Parameter Population: all participants from whom a PK sample was obtained and analyzed and whose PK parameter data was evaluated. One of the 12 participants took a prohibited medication that might have decreased the absorption of eltrombopag during the treatment period and was hence excluded from the PK Parameter Population.|||nanograms/milliliter (ng/ml)||95% Confidence Interval|Geometric Mean
1448603|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Age|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of participants in each age category are illustrated by the n's in the category titles."|Baseline, Day 15|FAS|||10^9/Liter||Standard Deviation|Mean
1448604|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Sex|"Change from Baseline was calculated as the Day 15 value minus the Baseline value. The numbers of females and males in each treatment group are illustrated by the n's in the category titles."|Baseline, Day 15|FAS|||10^9/Liter||Standard Deviation|Mean
1448605|NCT00861601|Secondary|Change From Baseline in Platelet Counts on Day 15 by Child-Pugh Class|Change from Baseline was calculated as the Day 15 value minus the Baseline value. The Child-Pugh (CP) score (ranging from 5 to 15, with 5 being mild and 15 being severe), calculated based on total bilirubin, serum albumin, international normalized ratio, ascites, and hepatic encephalopathy, is used to assess the severity of liver disease. A CP score of 5 or 6 is classified as Class A (mild), a score of 7-9 is classified as Class B (moderate), and a score >=10 is classified as Class C (severe). Participants with a CP score <10 were enrolled in the study.|Baseline, Day 15|FAS. The number of participants categorized as Class A or Class B is given in the category titles.|||10^9/Liter||Standard Deviation|Mean
1448606|NCT00861601|Secondary|Percentage of Responders on Day 22|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 22 after receiving eltrombopag for an additional week from Day 15, on which his or her platelet count was <80 x 10^9/Liter.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.|||percentage of responders||95% Confidence Interval|Mean
1448607|NCT00861601|Secondary|Percentage of Responders on Day 15|A responder was defined as a participant with a platelet count within the target range (>=80 x 10^9/Liter) on Day 15.|Day 15|FAS|||percentage of responders||95% Confidence Interval|Mean
1448608|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw. Change from Baseline was calculated as the value at each visit minus the Baseline value.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Standard Deviation|Mean
1448609|NCT00861601|Secondary|Change From Baseline in Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22. Change from Baseline was calculated as the value at each visit minus the Baseline value.|Baseline, Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group is missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Standard Deviation|Mean
1448610|NCT00861601|Secondary|Platelet Counts at Day 22|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 22|FAS. Participants in the 12.5 mg group have no data on Day 22 because they received the medication for only 14 days. Only 6 participants in the 25 mg group and 2 participants in the 37.5 mg group received the medication for an additional week, because they had a platelet count <80 x 10^9/Liter on Day 15.|||10^9/Liter||Full Range|Median
1448611|NCT00861601|Secondary|Platelet Counts by Post-Treatment Visit|Platelet counts were measured by blood draw.|4 days post-treatment, 8 days post-treatment, and 15 days post-treatment|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Full Range|Median
1448612|NCT00861601|Secondary|Platelet Counts by Treatment Visit|Platelet counts were measured by blood draw. The Final Assessment Point is the last visit during the treatment period, which is Day 15 or Day 22.|Day 1 (Baseline), Day 8, Day 15, and Final Assessment Point (Day 15 or Day 22)|FAS. The number of participants analyzed varies by visit, because the platelet count data on 4 days post-treatment in one participant in the 37.5 mg group are missing and the platelet count data post-specific therapies affecting the evaluation of efficacy are excluded from this efficacy analysis.|||10^9/Liter||Full Range|Median
1448770|NCT00859638|Secondary|Rapid Assessment of Physical Activity||4 months|||||||
1448614|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline of Platelet Counts and Child-Pugh Class as Covariates)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts and Child-Pugh class as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS|||10^9/Liter||95% Confidence Interval|Mean
1448615|NCT00861601|Secondary|Analysis of Covariance for Three Patterns of Dose Response Using the Change From Baseline in Platelet Counts (Baseline Platelet Counts as Covariate)|Exploratory analysis was conducted to see a dose response/trend when a dose goes high with the changes from baseline in platelet counts (12.5 mg, 25 mg, and 37.5 mg) on Day 15 of each subject. The data were analyzed with baseline of platelet counts as covariate for the following dose response pattern using contrast: (1) linearity, (2) saturation at the medium dose, (3) onset of response at the high dose.|Baseline, Day 15|FAS|||10^9/Liter||95% Confidence Interval|Mean
1448616|NCT00861601|Primary|Change From Baseline in Platelet Counts on Day 15|Platelet counts were measured by blood draw. Change from Baseline was calculated as the Day 15 value minus the Baseline value.|Baseline, Day 15|Full Analysis Set (FAS): all enrolled participants, excluding those who received no doses of eltrombopag during the treatment period, those without a baseline platelet assessment, and those without at least one on-therapy (scheduled or unscheduled) platelet assessment.|||10^9/Liter||95% Confidence Interval|Mean
1448617|NCT00861471|Secondary|Median Overall Survival Time|Overall survival time is the time from the start of therapy till death. Median overall survival reported here is the time when 50% of the participants are alive.|up to 4 years|Based on intent-to-treat population|||months||95% Confidence Interval|Median
1448618|NCT00861471|Secondary|Time to PSA Progression|Time to PSA pregression is defined as the time at which therapy statred and ends when the PSA increased by 50% above the nadir confirmed on a second determination.|up to 2 years|Based on intent-to-treat population|||days||95% Confidence Interval|Mean
1448619|NCT00861471|Secondary|Percentage of Participants With Measurable Disease Response|Measurable disease response is defined as the number of participants whose best response is complete response or partial response over the number of patients with measurable desease according to the Response Evaluation Criteria in Solid Tumors (RECIST).|up to 2 years|Based on the participants with measurable disease|||percentage of participants|||Number
1448620|NCT00861471|Secondary|Percentage of Participants With Greater or Equal to 80% PSA Reduction From Baseline Without Clinical or Radiologic Evidence of Progression|PSA was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population|||percentage of participants|||Number
1448621|NCT00861471|Primary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response is defined as a greater than or equal to a 50% decrease in PSA from the baseline without clinical or radiologic evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST). PSA concentration was measured at baseline on day 1/cycle 1 before treatment, then day 1 of every cycle afterwards during therapy.|up to 9 months|The analysis was based on intent-to-treat population.|||percentage of participants|||Number
1448622|NCT00861341|Primary|Percent Platelet Aggregation Induced by Collagen|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using collagen (2ug.mL). At each time point the results are shown for maximum percent aggregation with collagen for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|baseline and day 6-9||||maximum percentage aggregation||Standard Deviation|Mean
1448623|NCT00861341|Primary|Percent Platelet Aggregation Induced by Arachidonic Acid|Platelet aggregation was performed by the turbidimetric method of Born with simultaneous measurement of ATP release using a Chrono-log Lumi-Aggregometer with AGGRO/LINK for Windows Software version 5.1.6. Platelet rich plasma was placed in a silicone-coated cuvette with constant stirring at 1200 rpm using a siliconized stir bar for measurement of aggregation and ATP release. Aggregation was initiated using arachidonic acid (0.5 mM). At each time point the results are shown for maximum percent aggregation with arachidonic acid for all subjects. Sample 1 was obtained at baseline (BL). Sample 2 was drawn on the same day after ingestion of a single dose of 30 mg of pioglitazone. Sample 3 was obtained 6–9 days later after the subject had ingested a single 81 mg dose of aspirin (ASA), and sample 4 was drawn later that day after ingestion of 30 mg of pioglitazone.|at baseline and days 6-9|Analysis population determined per protocol.|||maximum percentage aggregation||Standard Deviation|Mean
1448624|NCT00861263|Primary|Number of Patients With Persistent or Recurrent Bleeding|The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.|up to 6 yrs after after the endoscopy||||participants|||Number
1448625|NCT00861198|Primary|Successful Procedure Completion|Defined based on the indication for SpyGlass. For cases involving biliary or pancreatic stones the procedure was considered successful when complete stone clearance was accomplished. For cases involving established or suspected nonstone-related lesions of the pancreatobiliary system, success was defined when all of the following criteria were met: successful advancement of the SpyScope to the desired target, adequate visualization of the area of interest and successful applications of all diagnostic and/or therapeutic maneuvers that were deemed necessary based on the endoscopic findings.|baseline||||participants|||Number
1448626|NCT00861146|Primary|Smoking Abstinence|7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking|2 weeks||||participants|||Number
1448627|NCT00861146|Secondary|Proportion of Days Heavy Drinking|Heavy drinking days were defined as days with > 6 standard drinks per day for men and > 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.|follow-up weeks 9-12||||proportion of days||Standard Deviation|Mean
1448771|NCT00859638|Secondary|Self-efficacy for Chronic Disease Scale||4 months|||||||
1448629|NCT00860951|Primary|Accuracy of Typing With BCI Keyboard.|"Accuracy for the sentence typed in each environment was calculated as the percentage of characters for which the result character matched the target character. The target characters were determined based on the next character needed to complete the sentence to be copied. In the case of errors, the next character was therefore a backspace to correct the error. The target characters were modified by subject comments to account for errors in selecting the next character.~Once sentence was typed in each environment in each session on a separate day. From the three repeated sessions, there were therefore 9 total sentences per subject with 3 measures for each environment. These were treated as repeated measures for the analysis."|mean score from 3 sessions over 29 days||||percentage accuracy||Full Range|Mean
1448630|NCT00860847|Secondary|1.Plasma Lipids: Total Plasma Cholesterol and Triglycerides, LDL-Cholesterol, HDL-Cholesterol, and VLDL-Cholesterol Determined by the Precipitation Method; 2. Endothelial Markers and Inflammation: C-reactive Protein and Homocysteine, as Well as GSH||1 year|||||||
1448631|NCT00860847|Primary|Rate of Change in Total Coronary Calcium Scores by Computed Tomography|progression of coronary artery calcium deposits as determined by computed tomography as measured by the Agatston score: The Agatston score was calculated by multiplying the lesion area (mm^2) by a density factor. The density was measured in Hounsfield units, and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater The endpoint is the mean change (end of study value - baseline value) in each group.|1 year|all participants were analyzed|||Agatston score change||Standard Deviation|Mean
1448632|NCT00860795|Secondary|Maximal Levels of Interleukin 12 (pg/ml)|interleukin 12 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat|||interleukin 12 level (pg/ml)||Standard Deviation|Mean
1448633|NCT00860795|Secondary|Maximal Levels of Interleukin 6 (pg/ml)|interleukin 6 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat|||interleukin 6 level (pg/ml)||Standard Deviation|Mean
1448634|NCT00860795|Secondary|Maximal Levels of Interleukin 2 (pg/ml)|interleukin 2 was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|intention to treat|||interleukin 2 level (pg/ml)||Standard Deviation|Mean
1448635|NCT00860795|Secondary|Adverse Effects||30 days|intention to treat|||participants|participants||Number
1448636|NCT00860795|Secondary|Maximal CD25/69 Activation (% of NK CD25/69+ Cells)|NK cells with evidence of CD25/69 activation were assessed on days 2, 3, 7, and 10. The highest percentage found on one of these days in each participant was categorized as the the maximal CD25/69 activation|10 days|intention to treat|||(% of NK CD25/69+ cells)||Standard Deviation|Mean
1448637|NCT00860795|Secondary|Maximal Levels of Interferon Alpha (pg/ml)|interferon alpha was measured on days 2, 3, 7, 10 in peripheral blood mononuclear cells. The highest level on any of these days in each participant was chosen as the maximal level and used for the analysis.|10 days|Intention to treat|||interferon alpha level (pg/ml)||Standard Deviation|Mean
1448638|NCT00860795|Primary|Maximal Level of Tumor Necrosis Factor Alpha (pg/ml)|tumor necrosis factor alpha NK cells and evidence of CD25/69 activation|10 days|Intention to treat|||tumor necrosis alpha level (pg/ml)||Standard Deviation|Mean
1448639|NCT00860743|Primary|Heart Rate Variability (Aim 2)|Heart rate variability (HRV) was measured before and after exposure to intermittent hypoxia following administration of a placebo or antioxidant cocktail. Heart rate variability refers to beat-to-beat alterations in heart rate. Under resting conditions, the electrocardiogram of healthy individuals reveals periodic variation in R-R intervals. To measure HRV, R-R interval data are presented in a graph, in which the y-axis plots the R-R intervals (ms2), and the x-axis the total number of beats. Spectral analysis of the graph transforms the signal from time to frequency on the x-axis (Hz), by representing the signal as a combination of sine and cosine waves, with different amplitudes and frequencies. The approach uses Fourier transforms. The heart rate spectrum contains a high frequency (0.15-0.4 Hz) component, which is synchronous with respiration and a low frequency (0.04 to 0.15 Hz) component that appears to be mediated by both the vagus and cardiac sympathetic nerves.|Within the same experimental session|Measurements were made before and after intermittent hypoxia following administration of a placebo or antioxidant cocktail. Please note that analysis of the heart rate variability measures for the healthy group have not been completed to date.|||ms2/Hz||Standard Error|Mean
1448640|NCT00860743|Primary|Ventilation (Aim 1)|Ventilation was measured before and after exposure to intermittent hypoxia in males and females. Ventilation was measured using a pneumotachograph, which is a flow measuring device.|Within the same experimental session||||fraction of baseline||Standard Error|Mean
1448641|NCT00860535|Primary|Growth Factor Signature (GFS) Change From Baseline Measured by Time Weighted Average (TWA) for Days 1 to 22|"The GFS was measured by microarray analysis using the entire 101 gene signature.~The TWA is the area under the curve (AUC) divided by the time interval (for this study it was the AUC of gene-expression divided by Days 1 to 22).~Participants with blast phase Ph+ CML or Ph+ ALL were measured for change in the GFS post-treatment when treated with imatinib, dasatinib, or nilotinib, using Microarray. Change was represented as the GFS Fold Ratio of TWA for Days 1 to 22 to Baseline."|Baseline to 22 Days After Initiation of Therapy||||GFS Fold Ratio-TWA[Days1-22] to baseline||90% Confidence Interval|Mean
1448642|NCT00860535|Primary|Growth Factor Signature (GFS) Variability at Baseline|"The GFS was measured by microarray analysis using the entire 101 gene signature. The GFS is quantified as the change in gene expression between two separate samples collected from the same patient. The signature has 101 genes in two oppositely regulated arms, which are pre-specified. The expression of genes in the UP arm goes up with increasing pathway activity, and the expression of genes in the DOWN arm goes down with increasing pathway activity.~The GFS variability was represented by the GFS change between two baseline samples (Mean GFS Fold Ratio [Screening to Day 1 Predose])."|Screening to Day 1 Predose|Participants whose GFS was measured using microarrays to determine the pretreatment baseline variability in participants with blast phase Ph+ CML or Ph+ ALL.|||GFS Fold Ratio-Screening to Day1 Predose||90% Confidence Interval|Mean
1448643|NCT00860470|Secondary|Small for Gestation Age|Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).|December 2014||||participants|||Number
1448654|NCT00860457|Primary|Complete Response Rate|Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.|3 years||||percentage of patients|||Number
1448655|NCT00860405|Other Pre-specified|Acute Renal Failure (ARF)|Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.|From baseline until 2nd postop morning.|Safety Population (SAF) = All randomized patients treated with study drug.|||Participants|||Number
1448656|NCT00860405|Other Pre-specified|Mortality|Mortality was reported for the time period from screening until the end of follow-up.|From screening to end of follow-up|Safety Population (SAF) = All randomized patients treated with study drug|||Participants|||Number
1448657|NCT00860405|Other Pre-specified|Length of Stay on the Intensive Care Unit (ICU)|Length of stay (number of days) on the intensive care unit (ICU).|From admission to ICU until discharge from ICU|Safety Population (SAF) = All randomized patients treated with study drug.|||Days||Inter-Quartile Range|Median
1448658|NCT00860405|Other Pre-specified|Calculated Perioperative Red Blood Cell (RBC) Loss|"Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit [baseline] – hematocrit [2nd postop morning]) + transfused RBC volume2;~Predicted blood volume (mL) = 80 × body weight (kg)~Transfused RBC volume = 0.7 × infused packed RBC"|2 days|Safety Population (SAF) = All randomized patients treated with study drug.|||ml/kg||Standard Deviation|Mean
1448659|NCT00860405|Secondary|Fluid Balance|Balance of total fluid input and total fluid output|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.|||ml/kg||Standard Deviation|Mean
1448660|NCT00860405|Secondary|Fluid Output|Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.|||ml/kg||Standard Deviation|Mean
1448661|NCT00860405|Secondary|Fluid Input|Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning|2 days|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation|||ml/kg||Standard Deviation|Mean
1448662|NCT00860405|Secondary|Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)|Per-protocol population (PP) = All patients in the ITT set without any major protocol violation|||mm Hg||Standard Deviation|Mean
1448663|NCT00860405|Primary|Total Volume of Colloid Solution Required Intraoperatively|Total volume of study drug plus rescue colloid, if applicable|Day 1 (intraoperatively)|Per-protocol population (PP) = All patients in the Intention-to-treat (ITT) set without any major protocol violation.|||ml/kg||Standard Deviation|Mean
1448664|NCT00860314|Secondary|Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position|Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.|30 seconds after cardioversion||||participants|||Number
1448665|NCT00860314|Secondary|Mean Energy Requirement for Successful Cardioversion|Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.|30 seconds after cardioversion||||Joules||Standard Deviation|Mean
1448666|NCT00860314|Primary|Number of Successfully Cardioverted Participants for Each Electrode Position|After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.|30 seconds after cardioversion||||participants|||Number
1448667|NCT00860314|Secondary|Mean Number of Cardioversion Shocks||30 seconds after cardioversion||||Shocks||Standard Deviation|Mean
1448668|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 8|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 8|FAS (LOCF)|||participants|||Number
1448669|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 6|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 6|FAS (LOCF)|||participants|||Number
1448670|NCT00860262|Secondary|Patients Achieving Normal Blood Pressure Response at Week 4|Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90|week 4|FAS (LOCF)|||participants|||Number
1448671|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 8|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 8|FAS (LOCF)|||participants|||Number
1448672|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 6|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 6|FAS (LOCF)|||participants|||Number
1448673|NCT00860262|Secondary|Patients Achieving Systolic Blood Pressure Response at Week 4|SBP < 140 mmHg or reduction of >= 15 mmHg|baseline, week 4|FAS (LOCF)|||participants|||Number
1448674|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 8|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 8|FAS (LOCF)|||participants|||Number
1448675|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 6|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 6|FAS (LOCF)|||participants|||Number
1448676|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Response at Week 4|DBP < 90 mmHg or reduction of >= 10 mmHg|baseline, week 4|FAS (LOCF)|||participants|||Number
1448677|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 8|SBP < 140 mmHg and DBP < 90 mmHg|week 8|FAS (LOCF)|||participants|||Number
1448678|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 6|SBP < 140 mmHg and DBP < 90 mmHg|week 6|FAS (LOCF)|||participants|||Number
1448679|NCT00860262|Secondary|Patients Achieving Blood Pressure Control at Week 4|SBP < 140 mmHg and DBP < 90 mmHg|week 4|FAS (LOCF)|||participants|||Number
1448680|NCT00860262|Secondary|Patients Achieving Diastolic Blood Pressure Control at Week 8|DBP < 90 mmHg|week 8|FAS (LOCF)|||participants|||Number
1448772|NCT00859638|Secondary|Health Care Utilization||4 months|||||||
1448693|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in DBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448694|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in DBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448695|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in DBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448696|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in DBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448697|NCT00860262|Secondary|Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8|Overall mean reduction from a common mean baseline in DBP|baseline and week 8|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448698|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1|Overall mean reduction from a common mean baseline in SBP|baseline and week 1|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448699|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2|Overall mean reduction from a common mean baseline in SBP|baseline and week 2|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448700|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4|Overall mean reduction from a common mean baseline in SBP|baseline and week 4|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448701|NCT00860262|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6|Overall mean reduction from a common mean baseline in SBP|baseline and week 6|Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448702|NCT00860262|Primary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8|Overall mean reduction from a common mean baseline in SBP|baseline and week 8|Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
1448703|NCT00860249|Primary|Completion of CRC Screening|What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months from initial contact|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.|||participants|||Number
1448704|NCT00860249|Secondary|The Secondary Outcome for the Study is the Time to Screening Completion.|This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.|6 months after randomization|Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.|||participants|||Number
1448705|NCT00860171|Secondary|Relapse Rate|Summarized using cumulative incidence estimates combining all patients and will be utilized as a rough guide to the potential benefits and toxicities of this therapy, but no formal statistical comparisons with regard to efficacy will be made because of the phase I nature of this trial.|Up to 6 years|||||||
1448706|NCT00860171|Secondary|Progression-free Survival|Kaplan-Meier estimates will be calculated.|Up to 6 years||2018-12-31|12/2018||||
1448707|NCT00860171|Secondary|Overall Survival||Up to 6 years||||days||Standard Deviation|Mean
1448708|NCT00860171|Secondary|Adverse Events|Descriptive statistics will be calculated. DLT will be defined by the Bearman Scale that is designed to address the specific toxicities associated with transplantation.|Up to 6 years||||number of adverse events|||Number
1448709|NCT00860171|Primary|I-131 Activity Administered||At time of I-131 therapy||||mCi I-131||Full Range|Mean
1448710|NCT00860171|Primary|Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant|"Dose escalation/de-escalation will be conducted by the two-stage approach introduced by Storer. Escalation will continue until a dose-limiting toxicity (DLT) occurs. A DLT will be defined as a therapy-related grade III or IV Bearman (transplant) toxicity. The MTD is estimated to be the dose that is associated with a toxicity rate of 25% (Bearman grade 3-4)."|Within 30 days post-transplant||||Gray of I-131 (absorbed dose that the I|||Number
1448711|NCT00860158|Secondary|To Estimate Safety and Tolerability of LHRH Plus Dasatinib||18 months|||||||
1448712|NCT00860158|Secondary|To Evaluate the Impact of Dasatinib Plus LHRH on Expression of Selected Biomarkers||18 months|||||||
1448717|NCT00860067|Secondary|Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
1448718|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-180 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
1448719|NCT00860067|Secondary|Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
1448720|NCT00860067|Secondary|The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination|Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|Days 0-28 post vaccination|The Safety Population included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up safety data were recorded (Q=1198; All FM=598).|||participants|||Number
1448721|NCT00860067|Secondary|The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination|Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite. Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.|Days 0-14|The Evaluable Safety Population for solicited symptoms included participants who received any investigational product (Q=1198; All FM=600) and for whom any follow-up solicited symptom safety data were recorded during the summarized period (Q=1197; All FM=597).|||participants|||Number
1448722|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1182; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and were seropositive to the strain (Q=930; FV=231).|||participants|||Number
1448723|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had post-dose HAI measurement (Q=1182; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were seropositive to the strain (Q=983; FY=249).|||participants|||Number
1448724|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1182; AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=373; All FM=196).|||participants|||Number
1448725|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590) and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were seropositive to the strain (Q=291; All FM=160).|||participants|||Number
1448726|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FV=297), and serosusceptible (Q=250; FV=66).|||participants|||Number
1448773|NCT00859638|Secondary|Self-rated Health||4 months|||||||
1448727|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292), and were serosusceptible to the strain (Q=197, FY=43).|||participants|||Number
1448728|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).|||participants|||Number
1448729|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.|Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.|Day 28-35|Participants who received a full dose of investigational product (Q=1198, All FM=600), had post-dose HAI measurement (Q=1182; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181, All FM=589), and were serosusceptible to the strain(Q=889, All FM=429).|||participants|||Number
1448730|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose.||Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301; All FM=600,), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=290), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=298; All FM=590).|||participants|||Number
1448731|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FV=301), had pre-dose and post-dose HAI measurement (Q=1181, FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were seropositive to the strain (Q=930, FV=231).|||participants|||Number
1448732|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, FY=299), had pre-dose and post-dose HAI measurement (Q=1181, FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q1180; FY=292), and were seropositive to the strain (Q=983, FY=249).|||participants|||Number
1448733|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198, AFM=600), had pre-dose and post-dose HAI measurement (Q=1181, AFM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=373, All FM=196).|||participants|||Number
1448734|NCT00860067|Secondary|The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were seropositive to the strain (Q=291; All FM=160).|||participants|||Number
1448735|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FV=301), had pre-dose and post-dose HAI measurement (Q=1181; FV=298), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FV=297), and were serosusceptible to the strain (Q=250; FV=66).|||participants|||Number
1448736|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299), had pre-dose and post-dose HAI measurement (Q=1181; FY=292), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292), and were serosusceptible to the strain (Q=197; FY=43).|||participants|||Number
1448737|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=807; All FM=393).|||participants|||Number
1448738|NCT00860067|Secondary|The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline. Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; All FM=600), had pre-dose and post-dose HAI measurement (Q=1181; All FM=590), had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; All FM=589), and were serosusceptible to the strain (Q=889; All FM=429).|||participants|||Number
1448739|NCT00860067|Secondary|The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.|Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.|Day 0 and Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=298; FV=300; All FM=598), had pre-dose and post-dose HAI measurement (Q=1181; FY=292; FV=298; All FM=599), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1180; FY=292; FV=297; All FM=589).|||participants|||Number
1448740|NCT00860067|Primary|The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.|Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.|Day 28-35|Participants who received a full dose of investigational product (Q=1198; FY=299; FV=301;All FM=600), had post-dose HAI measurement (Q=1182; FY=292; FV=298; All FM=590), and had no protocol deviation that could have interfered with the generation or interpretation of an immune response (Q=1181; FY=292; FV=297; All FM=589).|||geometric mean titer||Full Range|Geometric Mean
1448741|NCT00860028|Secondary|Number of Participants Who Reported an Adverse Event in the Varenicline Pretreatment Versus Placebo Pretreatment Conditions|Compares the number of participants who reported an adverse event in the extended varenicline pretreatment versus short-term varenicline pretreatment conditions during the 3-week placebo controlled pretreatment phase|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.|||Number of participants|||Number
1448742|NCT00860028|Primary|Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions|Compares the mean percentage of heavy drinking days over the 3-week placebo-controlled pretreatment phase comparing participants in the extended varenicline pretreatment versus the short-term varenicline pretreatment conditions. Heavy drinking defined as consuming 4 or more drinks per occasion for women and 5 or more drinks per occasion for men. Drinking in the final week of pretreatment prior to the quit-date is not included because both groups were receiving active varenicline during this period.|First 3 weeks (pretreatment)|All participants were included in the analysis, assuming an intention to treat method.|||percentage of heavy drinking days||Standard Deviation|Mean
1448743|NCT00860028|Primary|Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions.|Compares the number of participants who reported no smoking, not even a puff, from the quit date through until the end of treatment (i.e., last 4 weeks of treatment) in the varenicline versus placebo pretreatment conditions.|Last 4 weeks of treatment|All participants were included in the analysis, assuming an intention to treat method.|||Participants|||Number
1448744|NCT00859950|Primary|ODI|The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.|Day 1 (all subjects)||||events/hour||Standard Deviation|Mean
1448745|NCT00859937|Secondary|Changes in Laboratory Correlates|Changes in laboratory correlates pre-post therapy will be analyzed using paired t-tests. The association between RET gene rearrangements/mutations and tumor response, as well as the association between germ-line polymorp response, will be analyzed using Fisher's exact test. The correlative and genetic data will also be entered as cova only due to the small sample size) in a Cox regression model of progression-free survival.|Baseline and 4 weeks|Biomarkers not done due to insufficient clinical responses thus making the biomarker analysis scientifically untenable.||||||
1448746|NCT00859937|Secondary|Overall Survival|Kaplan-Meier curves will be generated and 90% confidence intervals will be derived.|Up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.|||months||90% Confidence Interval|Median
1448747|NCT00859937|Primary|Progression-free Survival|Progression-free survival from start of treatment to the time of disease progression or death from any cause was estimated using the Kaplan-Meier method.|up to 5 years|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.|||months||90% Confidence Interval|Median
1448748|NCT00859937|Primary|Response Rate|Response rate is percentage of the best overall response which recoded from the start of the treatment until diseases progression/recurrence. Response criteria are defined using the international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) Committee: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.|Up to 2 months|There are two subtype cohorts, adenoid cystic carcinoma and non adenoid cystic carcinoma of malignant salivary gland tumors, with the same treatment. The two groups were analyzed separately and therefore no comparisons are made between the two groups.|||participants|||Number
1448794|NCT00859508|Primary|Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele|The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.|6 months||||participants|||Number
1448749|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities in Liver Function in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Safety laboratory measurements were obtained during the Qualification and Lead-In Periods and on Day 1 of the Double-Blind Period and at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24. BL was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from BL up to and including the last day of treatment plus 30 days. Liver function abnormality criteria: FDA Guidance for Industry: Premarketing Clinical Evaluation (July 2009). Data after rescue was also included. Abbreviations: Pretreatment (PreRX), upper limit of normal (ULN); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). Marked abnormality Low (High) defined: ALP, AST and ALT (>3*ULN); bilirubin (>2*ULN if PreRX <= ULN; >3*ULN if PreRX > ULN); AST or ALT plus (+) bilirubin elevation: AST or ALT >3*ULN and bilirubin >1.5*ULN within 14 days on or after ALT elevation.|Baseline to Week 24/end of treatment plus 30 days||||participants|||Number
1448750|NCT00859898|Secondary|Number of Participants With Marked Laboratory Abnormalities (Not Including Liver Function) in 24 Week Double Blind Treatment Period, Including Data After Rescue - Randomized, Treated Participants|Laboratory samples: Qualification and Lead-In Periods, Day 1, Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of Double-Blind Period. Baseline (BL)=last assessment prior to start of first dose of double-blind study medication. Data after rescue included. Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); Units per liter (U/L), blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); creatinine (>=1.5*preRX, >=2.5 mg/dL); glucose <54 (>350) mg/dL; creatine kinase (>5*ULN);calcium <7.5 (>=1 mg/dL from ULN and >= 0.5mg/dL from PreRX); sodium <130 or < 120 male/female (>150 mEq/L; potassium <=2.5 (>=6.0) mEq/L; bicarbonate <= 13 mEq/L; inorganic phosphorus: <=1.8 if age 17-65 or <=2.1 if age >=66, (>=5.6 if age 17-65 or >=5.1) mg/dL if age >=66; albumin <=2 (>6) g/dL; urine albumin(alb) / creatinine (creat) ratio (>1800 mg/g)|Baseline to Week 24/end of treatment plus 4 days|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||participants|||Number
1448751|NCT00859898|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Randomized, Treated Participants|12-Lead electrocardiograms (ECGs) were performed at entry into Lead-In Period Day -7 visit and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -7 for this parameter. Data after rescue included.|Week 24||||participants|||Number
1448752|NCT00859898|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Randomized, Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Heart rate values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently throughout the study. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||bpm||Standard Error|Mean
1448753|NCT00859898|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24 - Treated Participants|Measurements were taken during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 in the Double Blind Period. Blood pressure values were obtained: after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Systolic and Diastolic pressures were measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||mmHg||Standard Error|Mean
1448754|NCT00859898|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 13.0. Data after rescue included for all special AEs except hypoglycemia (excluded data after rescue). Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs except hypoglycemia, which excluded data after rescue.|||participants|||Number
1448774|NCT00859638|Primary|Physical Functioning Inventory (PFI)|The PFI is used to assess physical functioning in older adults. It contains 21 tasks from 4 subscales: activities of daily living, instrumental activities of daily living, mobility, moderate activities. A series of questions is used to determine whether the person experiences difficulty in completing a task, the level of difficulty they experience, and any changes to the method and/or frequency of task performance. The PFI is sensitive to steps in the natural history of functional decline that are often not assessed clinically. Range of scores: 0 (most difficulty); 100 (least difficulty).|4 months||||units on a scale||Standard Deviation|Mean
1448775|NCT00859586|Secondary|Incidence and Severity Induced GvHD, Proportion of DLI Engraftment, Peak Chimerism, Leukemia Response at Days Post DLI, Residual Leukemia Measured by Patient Chimerism, Leukemia Free Survival From Date Relapse, Safety of Mismatched DLI Procedure...||Severity of GvHD.|||||||
1448755|NCT00859898|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Events captured from baseline to last dose plus 4 days for AEs, plus 30 days for SAEs during the Double Blind 12 Week Period. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.|||participants|||Number
1448756|NCT00859898|Secondary|The Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized, Treated Participants|Adjusted mean change from baseline in total body weight at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg). Body weight measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||kg||Standard Error|Mean
1448757|NCT00859898|Secondary|Adjusted Mean Change From Baseline in HbA1C at Week 24 (LOCF) in Participants Whose Baseline HbA1C Category ≥9.0%|HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized, treated participants whose Baseline HbA1c was greater than, equal to (>=) 9.0%. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values, whose baseline HbA1c was >=9.0%.|||Percent of Hemoglobin||Standard Error|Mean
1448758|NCT00859898|Secondary|Percent Adjusted for Baseline HbA1c of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized, Treated Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values; N=202, 216, 203, respectively. n=number of responders: 92, 69, 72, respectively. n/N=percent. Percent is then adjusted for baseline HbA1c.|||Percent of participants||95% Confidence Interval|Number
1448759|NCT00859898|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (LOCF) - Randomized, Treated Participants|Data after rescue medication was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the Double-Blind Period.|Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
1448760|NCT00859898|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 (Last Observation Carried Forward) - Randomized Treated Participants|Adjusted mean change in HbA1c from baseline at Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, ie, last observation carried forward (LOCF) was determined. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the Qualification and Lead-In Periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the Double-Blind Period.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non-missing baseline and Week 24 (LOCF) values.|||Percent of hemoglobin||Standard Error|Mean
1448761|NCT00859833|Primary|Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest)|The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)|2 hours|Analysis was per protocol. All patients with analyzable data were included. 2/30 patients had technical problems with the MRI data that made their data unable to be analyzed.|||ratio||Standard Deviation|Mean
1448762|NCT00859651|Secondary|Change in Percent Density|Assessed by mammography and breast MRI.|Baseline to 1 year|Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).|||percentage of breast density||Standard Deviation|Mean
1448763|NCT00859651|Primary|Change in Serum 25(OH)D|25(OH)D level at the end of one year intervention|Baseline to 1 year|Data for this study (NCT00859651; n=20) is combined with the data for another study (NCT00976339; n=20).|||ng/ml||Standard Deviation|Mean
1448764|NCT00859638|Secondary|Eight Foot Walk Test||4 months|||||||
1448765|NCT00859638|Secondary|Balance Screen||4 months|||||||
1448776|NCT00859586|Primary|Overall Recipient Survival at 6-month Post-relapse of Disease|This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease.|6 months post-relapse of disease||||participants|||Number
1448777|NCT00859573|Primary|Mean Treatment Effectiveness Scores|Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported.|thrice weekly from week 3 through week 8|Participants that completed the 2 week residential treatment and entered the outpatient phase with intent to treat and missing urines treated as positive urines.|||scores on a scale||Standard Deviation|Mean
1448778|NCT00859547|Primary|Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher|Grade 0=normal.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
1448779|NCT00859547|Primary|Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher|ULN=upper limit of normal. Grade 0=normal; Grade 1=ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
1448780|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels|ULN=upper level of normal. Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
1448781|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels|LLN=lower level of normal. Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
1448782|NCT00859547|Primary|Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts|Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal. Platelets: Grade 0=normal. WBC: Grade 0=normal. Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8–10^9/L. Neutrophils: Grade 0=normal; Grade 1=<LLN–1.5x10^9/L; Grade 2=<1.5–1.0x10^9/L|Baseline and Day 29 from Baseline|Participants who received treatment with rThrombin.|||Participants|||Number
1448783|NCT00859547|Secondary|Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody|Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.|At Day 29|Participants who received study drug and had both baseline and on-treatment anti-rThrombin product antibody assessments.|||Participants|||Number
1448784|NCT00859547|Primary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Mild=asymptomatic or minor symptoms; intervention not indicated. Moderate=requiring only minimal, local, or noninvasive intervention. Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated. Life-threatening=indicating intensive care or urgent invasive intervention.|Days 1 through 29, continuously|Participants who received treatment with rThrombin.|||Participants|||Number
1448785|NCT00859547|Primary|Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment|Days 1 through 29, continuously|Participants who received treatment with rThrombin.|||Participants|||Number
1448786|NCT00859521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1448787|NCT00859521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1448788|NCT00859521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
1448789|NCT00859508|Secondary|Radiographic Evaluation|"Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit)~Adhesion formation~Membrane formation~Abnormal thickening along graft (device implant) site~Brain edema adjacent to graft (device implant) site"|6 months|||||||
1448790|NCT00859508|Secondary|Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)||up to 6 months|||||||
1448791|NCT00859508|Secondary|Wound Healing Assessment||up to 6 months|||||||
1448792|NCT00859508|Secondary|Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)||up to 6 months|||||||
1448793|NCT00859508|Secondary|Modified Rankin Scale (Patient Function Assessment)||up to 6 months|||||||
1448795|NCT00859469|Secondary|Progression-free Survival|Time to radiologic disease progression or death|50 months||||months||95% Confidence Interval|Median
1448798|NCT00859430|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1448799|NCT00859430|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1448800|NCT00859430|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
1448801|NCT00859339|Secondary|Correlate Biomarker Expression|To evaluate the impact of sunitinib malate in combination with cisplatin and gemcitabine on expression of selected biomarkers.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)||||||
1448802|NCT00859339|Secondary|Progression Free Survival||18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)||||||
1448803|NCT00859339|Secondary|Objective Response Rate|To determine the objective response rate for patients with measurable disease according to RECIST.|18 months|No data was collected or analyzed for the secondary objective due to termination of the trial (toxicity)||||||
1448804|NCT00859339|Secondary|Safety Profile|Evaluate the safety profile of Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy in participants with TCC|18 months||||participants|||Number
1448805|NCT00859339|Primary|Pathological Complete Response (pCR) Rate.|number of participants with a pCR|18 months|8 participants were evaluable for pCR|||particpants with pCR|||Number
1448806|NCT00859313|Primary|Percent of Patients Without Device Failure|Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.|12 hours||||percent|||Number
1448807|NCT00859222|Other Pre-specified|Overall Survival (OS) [Phase I]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase I participants were followed for OS up to 12.1 months on this study.|All participants who received at least one dose of the study drug were followed for OS.|||months||Full Range|Median
1448808|NCT00859222|Secondary|Overall Survival [Phase II]|OS is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 4 months from the end of treatment until death or lost to follow-up. Phase II participants were followed for OS up to 27 months on this study.|All participants who received at least one dose of the study drug were followed for OS.|||months||Full Range|Median
1448809|NCT00859222|Other Pre-specified|6-Month Progression-Free Survival (PFS6) [Phase I]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.|||proportion of participants||95% Confidence Interval|Number
1448810|NCT00859222|Other Pre-specified|Progression-Free Survival (PFS) [Phase I]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.|||months||Full Range|Median
1448811|NCT00859222|Secondary|Progression-Free Survival (PFS) [Phase II]|PFS is defined as the time from study entry to the earliest documentation of disease progression or death. Patients alive without evidence of PD were censored at the date of last disease assessment.|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months.|All PII participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS.|||months||Full Range|Median
1448812|NCT00859222|Secondary|Best Radiographic Response|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles was a median (range) of 2 (1-6) PI Cohort 1, 4.5 (2-6) PI Cohort 2, 6 (2-10) PI Cohort 3, 5 PII GBM and 7 PII AG.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for response.|||participants|||Number
1448813|NCT00859222|Primary|6-Month Progression-Free Survival (PFS6) [Phase II]|PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry. Progressive disease was established based on RANO criteria (Wen et al JCO 2010).|Disease was assessed radiographically to document clinical progression every cycle on treatment and post-treatment every 8 weeks up to 12 months. Participants were followed for PFS6 up to 6 months since study entry.|All participants with measurable disease present at baseline and received at least one dose of the study drug were evaluable for PFS6.|||proportion of participants||95% Confidence Interval|Number
1448828|NCT00859053|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||hours||Full Range|Median
1448814|NCT00859222|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as an adverse event that (a) is related to the LBH589 and/or bevacizumab with an attribution of possible, probable, or definite, and (b) occurs during and/or begins during the first 30 days of the study treatment, and (c) meets any of the following criteria: grade 3 thrombocytopenia; grade 4 neutropenia lasting 7 days; grade 4 anemia lasting 7 days despite transfusion or growth factors; febrile neutropenia if ANC<0.5 x10^9/L; a QT interval corrected for heart rate (QTc) of 500–515 msec that did not stabilize to <480 msec after one week; a second occurrence of QTc 500–515 msec; any QTc >515 msec; any deep vein thrombosis (DVT) or pulmonary embolism (PE) while on fully therapeutic anticoagulation therapy; Grade 3 proteinuria lasting 14 days; or any other clinically significant Grade 3 toxicity despite maximal medical therapy lasting 7 days, any Grade 4 toxicity despite maximal medical therapy; or any Grade 3 or 4 toxicity resulting in study drug discontinuation.|Participants were assessed every 2 weeks while on study; The observation period for DLT evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for DLT.|||participants with DLT|||Number
1448815|NCT00859222|Primary|LBH589 Maximum Tolerated Dose (MTD) [Phase I]|The MTD LBH589 in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D). The MTD was not reached with 0 of 6 DLTs observed in the highest dose cohort but due to safety concerns higher doses of LBH589 with bevacizumab were neither planned nor tested. The RP2D was 30 mg/day orally, 3x per week, every other week.|Participants were assessed every 2 weeks while on study; The observation period for MTD evaluation was the first 30 days of treatment.|All PI participants who received at least one dose of the study drug were evaluable for MTD.|||mg/day orally, 3x per wk, every other wk|||Number
1448816|NCT00859131|Secondary|Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3||One year||||participants|||Number
1448817|NCT00859131|Secondary|Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3||One year||||participants|||Number
1448818|NCT00859131|Secondary|Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.||One year||||participants|||Number
1448819|NCT00859131|Secondary|Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis||one year||||participants|||Number
1448820|NCT00859131|Secondary|Graft Survival at One Year Post-transplant||One year||||participants|||Number
1448821|NCT00859131|Secondary|Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.||One year||||Patients|||Number
1448822|NCT00859131|Primary|Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.||One year||||participants|||Number
1448823|NCT00859053|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Study Discharge (end of study) was Day 4 (healthy participants) or Day 5 (hepatically impaired participants).|Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.|Analysis was done in safety population, defined as all the participants who received study medication.|||Participants|||Number
1448824|NCT00859053|Primary|The Apparent Volume of Distribution at Steady State (Vss/F)|Apparent volume of distribution was calculated by dividing the product of the dose and mean residence time (MRT) by AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.|||mL||Geometric Coefficient of Variation|Geometric Mean
1448825|NCT00859053|Primary|Apparent Clearance of Free BMS-790052 (CLu/F)|CLu/F was calculated by dividing the apparent total body clearance (CLT/F) by mean fraction of unbound drug (fu) for both (1 hour and 4 hour post dose) time points combined. Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/ λz, where λz was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK population.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1448826|NCT00859053|Primary|Apparent Total Body Clearance (CLT/F) of BMS-790052|Apparent total body clearance was calculated as dose/AUC(INF). AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in PK set population.|||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1448827|NCT00859053|Primary|Terminal Half-life (T-HALF) of BMS-790052|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||hours||Standard Deviation|Mean
1448844|NCT00858845|Other Pre-specified|Change in Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity was measured as bursts sympathetic nerve activity per minute.|Baseline, 3 months|One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.|||bursts/min||Standard Error|Mean
1448829|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052|AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
1448830|NCT00859053|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052|AUC(0-T) was calculated by the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
1448831|NCT00859053|Primary|Maximum Observed Plasma Concentration (Cmax) of BMS-790052|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analysed for BMS-790052 by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)|Analysis was performed in the Pharmacokinetic population (all participants who received study drug and had adequate PK profiles).|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1448832|NCT00859040|Secondary|Overall Survival|Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame.|34 months||||percentage of participants|||Number
1448833|NCT00859040|Secondary|Median Time to Progression|Per protocol, the study’s secondary objectives are to be evaluated “for the estimate of median ... PFS ... at time of interest.” At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information.|34 months|"Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up).~[NOTE: The other 2 patients who were treated on study each remain progression-free after > 1000 days.]"|||days||Full Range|Median
1448834|NCT00859040|Secondary|Median Progression-Free Survival||5 years||||weeks||95% Confidence Interval|Median
1448835|NCT00859040|Secondary|Treatment-related Events|All Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms|5 years||||events|||Number
1448836|NCT00859040|Secondary|Response Rate|"Number of participants to experience complete or partial response on study treatment.~For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.~Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. The steroid dose at the time of the scan evaluation should be no greater than the maximum dose used in the first 8 weeks from initiation of therapy."|5 years||||participants|||Number
1448837|NCT00859040|Primary|6 Month Progression Free Survival|Progression is defined using Modified Macdonald Criteria , using a >/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|6 months||||percentage of patients|||Number
1448838|NCT00859027|Secondary|Percent Change of Bone Turnover Markers|Bone turnover markers including N‐telopeptide (NTX), serum C‐telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication.|Baseline and 6 months||||Percent Change||Standard Error|Mean
1448839|NCT00859027|Primary|Percent Change in Bone Mineral Density|BMD was measured by dual-energy X-ray absorptiometry (Lunar DXA-IQ, Madison, WI, USA). The BMD of the femoral neck, total hip, and lumbar spine (L1-L4) was measured. Underlying data are no longer available; reported means have been estimated from the results publication.|baseline and 6 months||||Percent Change||Standard Error|Mean
1448840|NCT00859014|Secondary|Functional Outcome|Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.|90-days||||units on a scale||Inter-Quartile Range|Median
1448841|NCT00859014|Primary|Study Related Serious Adverse Events (SR-SAE)|"Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - Events"|2 Years||||Events|||Number
1448842|NCT00858962|Primary|Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)|PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule.|6-14 days after beginning co-administration of drugs|All subjects who completed study were included in the analysis.|||hr*ng/mL||Standard Deviation|Mean
1448843|NCT00858858|Primary|Protection Against DNA Damage by UDCA|p-H2AX levels are a measure of DNA damage. Our major outcome measure is the change in p-H2AX levels, expressed as relative densitometry units, after DCA perfusion in patients treated with oral UDCA. If UDCA protects against bile acid-induced DNA damage, then p-H2AX levels before and after perfusion should not change significantly.|After 8 weeks of UDCA treatment|Patients with Barrett's esophagus, only metaplastic epithelium evaluated. No data were collected from squamous epithelium as originally planned because our in vitro studies subsequently showed that DCA exposure did not cause DNA damage in squamous cells and, therefore, oral UDCA treatment would be meaningless for squamous esophagus.|||Relative Densitometry Units||Standard Error|Mean
1448845|NCT00858845|Secondary|Change in Proportion of Type 1 Fibers|Fibers were typed as I or II according to presence of myosin heavy chain.|Baseline, 3 months|One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.|||percentage of fibers||Standard Error|Mean
1448846|NCT00858845|Primary|Change in Citrate Synthase Activity as an Estimate of Mitochondrial Activity||Baseline, 3 months|One patient randomized to placebo underwent urgent orthotopic heart transplantation before second measure could be obtained.|||micromole/min/wet weight||Standard Error|Mean
1448847|NCT00858832|Primary|Endometritis Incidence|Number of participants who developed endometritis|One year||||participants|||Number
1448848|NCT00858780|Secondary|Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization|Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS.|Randomization (Week 0) up to Week 48|m-ITT analysis set.|||percentage of participants|||Number
1448849|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Full Range|Median
1448850|NCT00858780|Secondary|Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12|MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis.|Randomization (Week 0), Week 12|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1448851|NCT00858780|Secondary|Magnetic Resonance Imaging (MRI) Findings at Randomization|MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1448852|NCT00858780|Secondary|Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||units on a scale||Full Range|Median
1448853|NCT00858780|Secondary|Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mg/L||Full Range|Median
1448854|NCT00858780|Secondary|Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A higher rate is consistent with inflammation.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mm/hour||Full Range|Median
1448855|NCT00858780|Secondary|Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||minutes||Full Range|Median
1448856|NCT00858780|Secondary|Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.|||mm||Standard Error|Least Squares Mean
1448857|NCT00858780|Secondary|Participant Pain Visual Analog Scale (VAS) at Randomization|Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.|Randomization (Week 0)|m-ITT analysis set.|||mm||Standard Deviation|Mean
1448858|NCT00858780|Secondary|Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants answered “in general how would you rate your health over the last 2-3 weeks?” Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set.|||mm||Standard Error|Least Squares Mean
1448859|NCT00858780|Secondary|Participant General Health Visual Analog Scale (VAS) at Randomization|Participants answered “in general how would you rate your health over the last 2-3 weeks?” Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.|Randomization (Week 0)|m-ITT analysis set.|||mm||Standard Deviation|Mean
1448860|NCT00858780|Secondary|Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mm||Full Range|Median
1448861|NCT00858780|Secondary|Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48|PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||mm||Full Range|Median
1448862|NCT00858780|Secondary|Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||swollen joints||Full Range|Median
1448863|NCT00858780|Secondary|Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time point for each treatment arm, respectively.|||tender joints||Full Range|Median
1448864|NCT00858780|Secondary|Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48|DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and <2.6=remission.|Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1448865|NCT00858780|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 implied low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity and less than (<) 2.6=remission.|Randomization (Week 0)|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1448866|NCT00858780|Secondary|Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State|Participants who had DAS28 <=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100.|Randomization (Week 0) up to Week 48|m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.|||percentage of visits||Standard Deviation|Mean
1448867|NCT00858780|Secondary|Percentage of Participants With Remission or Low Disease Activity (LDA)|Participants who had DAS28 less than or equal to (<=) 3.2 were considered in remission or LDA state.|Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48|m-ITT analysis set. Here, ‘n’ signifies participants evaluable for each time-point for each treatment arm, respectively.|||percentage of participants|||Number
1448868|NCT00858780|Secondary|Time to Treatment Failure (TTF)|TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.|Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)|m-ITT analysis set.|||weeks||95% Confidence Interval|Median
1449002|NCT00857961|Secondary|Number of Participants With Adverse Events|A listing of adverse events is located in the Reported Adverse Events module.|Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)|All participants received all four doses of testosterone-MD lotion.|||participants|||Number
1448869|NCT00858780|Primary|Percentage of Participant Who Were Non-Failures|A participant was considered as non-failure if the calculated DAS28 <=3.2 at all visits or if the calculated DAS28 >3.2, the increase of calculated DAS28 from randomization (Week 0): was <0.6 at all visit or was >=0.6 but <1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.|Week 48|Modified intent-to-treat (m-ITT) analysis set included all randomized participants who received at least 1 dose of study medication after randomization and had at least 1 available evaluation after the first administration of study medication after randomization.|||percentage of participants|||Number
1448870|NCT00858702|Secondary|Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)|Drug-related, laboratory value change adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (laboratory AEs:abnormal changes in clinical laboratory values) was conducted for Safety Population. It excluded the patients who were not administered study drugs, or had no clinical laboratory data.|||Percent of participants|||Number
1448871|NCT00858702|Secondary|Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)|Drug-related adverse events are adverse events(AEs) as determined by the Investigator that can not be denied to be related to the study drugs. The relationship between adverse events and drugs were determined by the Investigator based on his/her clinical judgement. Factors used in determining relatedness included, but are not limited to, the medical history of the participant, use of concomitant medication, and the time course from drug administration to AE occurence.|At week 8|Safety analysis (Clinical AEs:subjective symptoms / objective findings) was conducted for Safety Population. It excluded the patients who were not administrated study drugs.|||Percent of participants|||Number
1448872|NCT00858702|Primary|The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85||Baseline to week 8|Primary analysis was conducted for full analysis set. It excluded the patients who were not administrated study drugs, or did not satisfy entry criteria, or had no data after randomisation.|||Percent of participants|||Number
1448873|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||1 year|||||||
1448874|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||8 weeks|||||||
1448875|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||1 year|||||||
1448876|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||8 weeks|||||||
1448877|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||1 year|||||||
1448878|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||8 weeks|||||||
1448879|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||1 year|||||||
1448880|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||8 weeks|||||||
1448881|NCT00858689|Secondary|Stanford Binet 5 (SB5)||1 year|||||||
1448882|NCT00858689|Secondary|Clinical Global Impression Scale||1 year|||||||
1448883|NCT00858689|Secondary|Clinical Global Impression Scale||8 weeks|||||||
1448884|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||1 year|||||||
1448885|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||8 weeks|||||||
1448886|NCT00858689|Secondary|Vineland Adaptive Behaviour Scales (VABS)||Baseline|||||||
1448887|NCT00858689|Secondary|Non-Verbal Associative Learning Task (NVALT)||Baseline|||||||
1448888|NCT00858689|Secondary|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)||Baseline|||||||
1448889|NCT00858689|Secondary|The Peabody Picture Vocabulary Test Third Edition (PPVT-III)||Baseline|||||||
1448890|NCT00858689|Secondary|Stanford Binet 5 (SB5)||Baseline|||||||
1448891|NCT00858689|Secondary|Clinical Global Impression Scale||Baseline|||||||
1448892|NCT00858689|Secondary|Parent Defined Target Symptoms Scale-Visual||Baseline|||||||
1448893|NCT00858689|Primary|ABC Irritability Subtest Score|ABC (Aberrant behavior checklist) Irritability subtest score was used|1 year|||||||
1448894|NCT00858689|Primary|ABC Irritability Subtest Score|ABC Irritability subtest score was used|8 weeks|completed 8 weeks of minocycline treatment|||units on a scale||Standard Deviation|Mean
1448895|NCT00858689|Primary|Change From Baseline of ABC Irritability Subtest Score at 8 Weeks|The 15-item Irritability Scale includes questions about aggression, self-injury, tantrums, agitation, and unstable mood on a scale of 0 to 45 with higher scores indicating greater severity. This scale has been successfully used in previous medication studies in children with autism and in patients with FXS and in a controlled trial of ampakine CX516 in FXS. All ABC subscales showed good reliability when used by parents and caregivers of individuals with FXS to assess behavior in the CX516 study NCT00054730, and yielded intraclass correlation coefficient (ICC) values of 0.7-0.9.|Baseline and 8 weeks|ABC-I change in subjects completing 8 weeks of minocycline treatment|||units on a scale||Standard Deviation|Mean
1448896|NCT00858637|Secondary|Vital Signs, Adverse Events, and Laboratory Values||throughout study|||||||
1448897|NCT00858637|Secondary|Change in Phosphorus(P), Calcium(Ca), Calcium-phosphorus Ion Product(PxCa) and Parathyroid Hormone (PTH)||16 weeks and 20 weeks|||||||
1448898|NCT00858637|Secondary|Percent Change in Serum LDL-cholesterol Levels From Baseline to Week 16 (LOCF) (ITT1)|Percent Change from Baseline to Week 16 (LOCF)|week16 minus week0|ITT1 population included all subjects who received a randomisation number, took at least 1 dose of study medication and had at least 1 central serum LDL-C value after the start of study medication.|||Percent Change of LDL-cholesterol||Standard Deviation|Mean
1449049|NCT00857818|Secondary|Mean Changes in Serum Prolactin Levels From Baseline||Baseline to Weeks 4, 8. and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1448899|NCT00858637|Primary|Percent Change in Serum LDL-cholesterol Levels From Week 16 to Week 20 (LOCF) (ITT2)|Percent Change from Week 16 to Week 20 (LOCF)|week20 minus week16|ITT2 population included all re-randomised subjects who completed 16 weeks in the active treatment groups (MCI-196 or simvastatin), received at least 1 dose of study medication in the Placebo-controlled withdrawal phase and had at least 1 central serum LDL-C value after Week 16.|||Percent Change of LDL-cholesterol||Standard Deviation|Mean
1448900|NCT00858507|Primary|Receipt of Primary Care at the VA|The primary aim of this study was to conduct a randomized controlled trial of different interventions aimed at increasing rates of treatment engagement among a community sample of treatment-naive homeless veterans.|within 4 weeks of intervention||||participants|||Number
1448901|NCT00858494|Secondary|Parental Report of an Adverse Event After a Dose of Study Medication|After each dose of study medication parents reported the presence of any adverse events|data collected after doses occurring up to 10 days after index visit|Study logs were returned in 37 of 49 enrolled participants. After each dose of study medication, the participant's parent indicated in the study log whether any adverse events were noted.|||doses|doses||Number
1448902|NCT00858494|Primary|Relief of Upper Respiratory Tract Infection (URI) Symptoms (Cough, Runny Nose, Nasal Congestion, Sneezing)1 Hour After Dose of Homeopathic Remedy.|For each dose of study medication, parents indicated which of the symptoms were present (runny nose, cough, nasal congestion, sneezing). Parents rated change in each symptom present one hour after a dose of study medication for up to 6 doses in study logs. Responses were dichotomized as at least some improvement or better (improvement) vs. no improvement or worse. The outcome measure is number of times that improvement in a specific symptom was noted after a dose of the homeopathic remedy. Completed study logs were received from 37 of 49 enrolled participants.|up to 10 days from index visit|Some symptoms were not present at each dose of the homeopathic remedy. Number of doses at which symptom was present: runny nose: 135, nasal congestion: 152, cough: 154, sneezing 81. The outcome is number of times improvement in each symptom was noted.|||doses|doses||Number
1448903|NCT00858468|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine.|Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.|21 days post-vaccination 2|GMTs were assessed on the Per-Protocol Population|||Titers||95% Confidence Interval|Geometric Mean
1448904|NCT00858468|Other Pre-specified|Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion).|Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.|21 days post-vaccination 2|Seroconversion analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.|||Percentage of participants|||Number
1448905|NCT00858468|Other Pre-specified|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection).|"Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.~Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40"|21 days post-vaccination 2|Seroprotection analysis was in all enrolled and vaccinated participants in the per-protocol immunogenicity population.|||Percentage of participants|||Number
1448906|NCT00858468|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.|Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.|Day 0 to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intend-to-treat population|||Percentage of participants|||Number
1448907|NCT00858442|Secondary|Length of the Graft|Central length measurement graft between the start and the end of the compression|start and end compression||||centimeter|Participants|Inter-Quartile Range|Median
1448908|NCT00858442|Secondary|Width of the Graft|Central width measurement graft between the start and the end of the compression|start and end compression||||centimeter|Participants|Inter-Quartile Range|Median
1448909|NCT00858442|Primary|Median Time Between Surgery Date and Start Date Compression.|Participants were followed from the date of surgery and the date of onset of compression for a minimum of 13.5 days and a maximum of 27 days|day|A participant may have one, two or three areas grafted|||day|Participants|Full Range|Median
1448910|NCT00858403|Secondary|Correlation Between Mutation and Inhibition and to Disease Control Rate and Response|To analyze Kras and epidermal growth factor receptor (EGFR) mutation and their correlation to the ERK pathway inhibition and to disease control rate and response.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
1448911|NCT00858403|Secondary|Correlation Between Extent of Inhibition and Concentration of Dasatinib|We planned to explore whether the extent of inhibition of ERK, SRC and Akt phosphorylation in lung cancer cells exposed ex vivo to dasatinib will correlate with the drug concentration of dasatinib.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
1448912|NCT00858403|Secondary|Number of Participant Progressors vs. Non-Progressors With Inhibition Response|We planned to assess whether the extent of inhibition of proto-oncogene tyrosine-protein kinase (SRC) and protein kinase B (Akt) phosphorylation in lung cancer cells exposed ex vivo and in vivo to dasatinib significantly differs between patients categorized as progressors or non-progressors through standard RECIST criteria.|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
1448913|NCT00858403|Secondary|Number of Participants With Serious Adverse Events (SAEs)|We evaluated toxicity of dasatinib in this patient population.|1 year, 4 months||||Participants|||Number
1448914|NCT00858403|Secondary|Number of Participants With Progression Free Survival (PFS) at 6 Months|We planned to estimate the 6 month progression free survival rate of dasatinib in this patient population.|1 year, 4 months|We were able to assess 4 of the 7 participants at 6 months.|||Participants|||Number
1448915|NCT00858403|Secondary|Number of Participants With Response to Dasatinib|We planned to estimate the single agent response rate to dasatinib in this patient population|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
1448916|NCT00858403|Primary|Number of Participant Progressors vs. Non-progressors With Tumor Response|We planned to assess whether the extent of inhibition of extracellular signal-regulated protein kinase (ERK) phosphorylation in lung cancer cells exposed ex vivo to dasatinib significantly differed between patients categorized as progressors or non-progressors through standard Response Evaluation Criteria In Solid Tumors (RECIST)|1 year, 4 months|The low accrual of 7 participants prevented us from completing the planned analysis. Target accrual was 40.||||||
1448917|NCT00858390|Primary|Primary Outcome Measure is IL-6 Level|Plasma IL-6 level measured by ELISA. The 12+/-2 hour time frame is prior to organ explantation.|12+/-2 hours||||pg/ml||Standard Deviation|Mean
1448918|NCT00858364|Secondary|Change From Baseline in Hemoglobin to End of Efficacy Treatment Period|Post-baseline hemoglobin values within 28 days after a RBC transfusion were not be used in the calculation of change.|Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|Primary analysis set with available baseline and at least 1 postbaseline value; if the EOETP value was missing, the last available postbaseline value was used.|||g/dL||Standard Deviation|Mean
1448919|NCT00858364|Secondary|Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin ≤ 8.0 g/dL From Week 1 to End of the Efficacy Treatment Period|Any red blood cell (RBC) transfusion (packed RBCs or whole blood) given or a hemoglobin ≤ 8.0 g/dL on or after study day 1 until the EOETP, inclusive.|Week 1 to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|Primary analysis set|||percentage of participants|||Number
1448920|NCT00858364|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa|Developing antibody incidence was defined as neutralizing antibody positive postbaseline with a negative or no result at baseline.|Baseline and end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later. the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|Randomized and consented participants who received at least one dose of study drug and with a postbaseline result.|||Participants|||Count of Participants
1448921|NCT00858364|Secondary|Percentage of Participants With an Objective Tumor Response|Objective response was defined as the incidence of a complete or partial response at any time during the study. Response was determined by the investigator’s assessment of the scans using RECIST version 1.0 or 1.1 depending on the timing of enrollment.|Day 1 to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.|The radiographic endpoint primary analysis set includes all participants in the primary analysis set who did not have disease progression prior to randomization.|||percentage of participants|||Number
1448922|NCT00858364|Secondary|Number of Participants With Adverse Events of Special Interest|Adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer to date, included the following categories: antibody-mediated pure red cell aplasia (PRCA), cardiac failure, central nervous system vascular disorders, convulsions, embolic and thrombotic events, hypersensitivity, hypertension, ischemic heart disease, malignancies, and severe cutaneous adverse reactions. Lack of efficacy and medication errors were also evaluated.|From first dose of study drug until 30 days after last dose; the median (range) duration of treatment was 10 (1 to 106) weeks in both groups.|All randomized and consented participants who received at least 1 dose of study drug. Four participants in the placebo group received at least 1 dose of darbepoetin alfa during the study and were included in the darbepoetin alfa group for safety analyses.|||Participants|||Count of Participants
1448923|NCT00858364|Secondary|Percentage of Participants With a Red Blood Cell Transfusion or Hemoglobin ≤ 8.0 g/dL From Week 5 to End of the Efficacy Treatment Period|Any red blood cell (RBC) transfusion (packed RBCs or whole blood) given or a hemoglobin ≤ 8.0 g/dL on or after study day 29 until the EOETP, inclusive.|Week 5 (day 29) to end of the efficacy treatment period (EOETP; defined as 21 days after either the last dose of study drug or the last dose of chemotherapy, whichever was later); median (range) duration of dosing was 10 (1 to 106) weeks in both groups.|Primary analysis set participants who were on study as of day 29|||percentage of participants|||Number
1448924|NCT00858364|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from randomization to the date of radiographic disease progression or death from any cause, whichever event occurred first. Participants without either event were censored on the date of their last disease assessment. Disease progression was based on the investigator’s assessment of scans using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or 1.1 depending on the timing of enrollment.|From randomization until disease progression or death; maximum time on follow-up was 87.23 months.|The radiographic endpoint primary analysis set includes all participants in the primary analysis set who did not have disease progression prior to randomization.|||months||95% Confidence Interval|Median
1448925|NCT00858364|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time from randomization to the date of death due to any cause. Participants were censored on the date of last contact (ie, the date the participant was last known to be alive) if they were not known to have died.|From randomization until death or end of study; maximum time on follow-up was 93.6 months.|Primary analysis set (all randomized and consented participants with non-small cell lung cancer who received at least one dose of study drug)|||months||95% Confidence Interval|Median
1448926|NCT00858247|Secondary|Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation|The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/L||Standard Deviation|Mean
1448927|NCT00858247|Secondary|Change in Triglycerides After 12 Weeks of Vitamin D Supplementation|The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
1448928|NCT00858247|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
1448929|NCT00858247|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation|LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high.|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
1448930|NCT00858247|Secondary|Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation|Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High|baseline, 12 weeks|One subject in the high-dose arm dropped out before the week 12 assessment, so the reporting population on the high dose arm was 23, not 24.|||mg/dL||Standard Deviation|Mean
1448931|NCT00858247|Primary|Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation|"Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia.~From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance."|Baseline, 12 weeks|All subjects had blood drawn but some tests such as insulin could not be done in some cases due to sample issues. This lab test was calculated from other parameters and not drawn per se. If the values obtained did not allow a calculation of the lab test, then the results could not be reported.|||HOMA score||Standard Deviation|Mean
1448932|NCT00858208|Other Pre-specified|Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)|IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.|Baseline and Week 102 or ET|SAS; N=participants with evaluable data at baseline; n=participants with evaluable data at specified time point|||millimeters of mercury (mmHg)|Participants|Standard Deviation|Mean
1448933|NCT00858208|Other Pre-specified|Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study|Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).|Baseline through Week 102|SAS|||participants|||Number
1448934|NCT00858208|Other Pre-specified|Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS|||participants|||Number
1448935|NCT00858208|Other Pre-specified|Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS|||participants|||Number
1448936|NCT00858208|Other Pre-specified|Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment|Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.|Every 6 weeks up to Week 102|SAS|||participants|||Number
1448937|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Previous Treatment of AMD|Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants for who data was collected about previous AMD treatment (yes/no); n=number of participants with evaluable data at specified time point|||scores on a scale|Participants|Standard Deviation|Mean
1448938|NCT00858208|Other Pre-specified|Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage|Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS subset of participants with AMD; n=participants with evaluable data at specified time point and stage of AMD|||logMAR|Participants|Standard Deviation|Mean
1448939|NCT00858208|Other Pre-specified|Change From Baseline VA at Final Visit by Age Group|Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.|Baseline, Week 102 or ET|SAS;N=participants with evaluable data; n=participants with evaluable data at specified time point and age group|||logMAR|Participants|Standard Deviation|Mean
1449050|NCT00857818|Secondary|Median Changes in Body Mass Index From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1448940|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point and item in questionnaire|||scores on a scale||Standard Deviation|Mean
1448941|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Week 102 or ET|SAS; N=participants with evaluable data|||scores on a scale||Standard Deviation|Mean
1448942|NCT00858208|Secondary|Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit|Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.|Baseline, Month 6, 12, 18, and 24|SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point|||scores on a scale||Standard Deviation|Mean
1448943|NCT00858208|Secondary|Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)|"VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the Pigment Epithelial Detachment (PED) present box ticked at Baseline Visit."|Baseline, Week 102 or ET|SAS subset of participants with RPED at baseline|||logMAR|Participants|Standard Deviation|Mean
1448944|NCT00858208|Secondary|Change From Baseline VA at Each Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, every 6 weeks up to Week 102|SAS; Number of participants analyzed (N)=participants with evaluable data; n=participants with evaluable data at specified time point|||logMAR|Participants|Standard Deviation|Mean
1448945|NCT00858208|Primary|Change From Baseline Visual Acuity (VA) at the Final Visit|VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.|Baseline, Week 102 or Early Termination (ET)|Safety Analysis Set (SAS) = Full Analysis Set (FAS): Enrolled participants who received at least 1 dose of Pegaptanib; Number of participants analyzed (N)=participants with evaluable data|||logMAR|Participants|Standard Deviation|Mean
1448946|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement; n=129).|||milligram (mg)|||Number
1448947|NCT00858143|Primary|Serious Adverse Events (SAE) and Adverse Events (AE)|Long term safety of Somavert in treatment of patients with acromegaly|Baseline up to 5 years|Safety Population; all patients who received at least one dose of Somavert® during the observation period.|||participants|||Number
1448948|NCT00858143|Secondary|Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population|Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set).|||milligram (mg)|||Number
1448949|NCT00858143|Secondary|Change From Baseline in Ring Size|Change from baseline: ring size at observation minus ring size at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||millimeters||Standard Deviation|Mean
1448950|NCT00858143|Secondary|Change From Baseline for Systolic Blood Pressure (BP)|Change: systolic blood pressure at observation minus systolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||millimeters Mercury (mmHg)||Standard Deviation|Mean
1448951|NCT00858143|Secondary|Change From Baseline for Diastolic Blood Pressure (BP)|Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||millimeters per mercury (mmHg)||Standard Deviation|Mean
1448952|NCT00858143|Secondary|Mean Change From Baseline for Body Weight|Change: body weight at observation minus body weight at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||kilogram (kg)||Standard Deviation|Mean
1448953|NCT00858143|Secondary|Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448954|NCT00858143|Secondary|Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448955|NCT00858143|Secondary|Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448956|NCT00858143|Secondary|Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448957|NCT00858143|Secondary|Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448958|NCT00858143|Secondary|Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448959|NCT00858143|Secondary|Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448960|NCT00858143|Secondary|Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)|Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)|ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.|||score on scale||95% Confidence Interval|Mean
1448961|NCT00858143|Secondary|Glucose Values Above Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448962|NCT00858143|Secondary|Glucose Values Within Normal Range in Diabetic Patients (Fasting)|Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448963|NCT00858143|Secondary|Absolute Glucose Values in Diabetic Patients (Fasting)|Absolute Glucose Values in Patients with Diabetes (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
1448964|NCT00858143|Secondary|Glucose Change From Baseline in Diabetic Patients (Fasting)|Change: glucose at observation minus glucose at baseline|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||95% Confidence Interval|Mean
1448965|NCT00858143|Secondary|HbA 1c Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Above Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
1448966|NCT00858143|Secondary|HbA 1c Values Below Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Below Normal Range|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
1448967|NCT00858143|Secondary|HbA 1c Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with HbA 1c Values Within Normal Range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448968|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||95% Confidence Interval|Mean
1448969|NCT00858143|Secondary|Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients|Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||Standard Deviation|Mean
1448970|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448971|NCT00858143|Secondary|Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients|Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448972|NCT00858143|Secondary|Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||Standard Deviation|Mean
1448973|NCT00858143|Secondary|Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients|Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||95% Confidence Interval|Mean
1448974|NCT00858143|Secondary|Absolute Hemoglobin A 1c (HbA 1c) Values|Absolute value Hemoglobin A 1c (HbA 1c)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||Standard Deviation|Mean
1448975|NCT00858143|Secondary|Absolute Glucose Values (2h oGTT)|Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
1448976|NCT00858143|Secondary|Absolute Glucose Values (Fasting)|Absolute Glucose values (fasting)|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
1448977|NCT00858143|Secondary|IGF-I Absolute Values|IGF-I absolute values (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||Standard Deviation|Mean
1448978|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range|Number of participants with glucose values (2h oGTT) above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448979|NCT00858143|Secondary|Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range|Number of participants with glucose values (2h oGTT) within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448980|NCT00858143|Secondary|Glucose Values Above Normal Range (Fasting)|Number of participants with glucose values above normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448981|NCT00858143|Secondary|Glucose Values Below Normal Range (Fasting)|Number of participants with glucose values below normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448982|NCT00858143|Secondary|Glucose Values Within Normal Range (Fasting)|Number of participants who have glucose values within normal range (fasting).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448983|NCT00858143|Secondary|Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>|Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
1448984|NCT00858143|Secondary|Change From Baseline Glucose (Fasting)|Change: glucose at observation minus glucose at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||milligram per deciliter (mg/dl)||Standard Deviation|Mean
1448985|NCT00858143|Secondary|HbA 1c Values Above Normal Range|Number of participants with HbA 1c values above normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448986|NCT00858143|Secondary|HbA 1c Values Below Normal Range|Number of participants who have HbA 1c values below normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participants|||Number
1448987|NCT00858143|Secondary|HbA 1c Values Within Normal Range|Number of participants who have HbA 1c values within normal range.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
1448988|NCT00858143|Secondary|Change From Baseline Hemoglobin A 1c (HbA 1c)|Change: HbA 1c at observation minus HbA 1c at baseline.|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||percent (%)||Standard Deviation|Mean
1448989|NCT00858143|Secondary|IGF-I Values Above Normal Range|Number of participants who have IGF-I values above normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
1448990|NCT00858143|Secondary|IGF-I Values Within Normal Range|Number of participants who have IGF-I values within normal range (local laboratory, different assay).|Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||participant|||Number
1448991|NCT00858143|Secondary|Change From Baseline Insulin-like Growth Factor I (IGF-I)|Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).|Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months|Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).|||micrograms per liter (ug/l)||Standard Deviation|Mean
1448992|NCT00858130|Secondary|Number of Study Participants With Improvements in Venous Symptoms (VEINES-Sym Score)|The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-Sym score increase at Visit 2 in comparison to Visit 1 were counted as having improved.|Vist 2 (Week 8)||||Participants|||Count of Participants
1448993|NCT00858130|Secondary|Number of Study Participants With Improvements in QOL (VEINES-QOL Score)|The VEINES-QOL/Sym is a patient-based questionnaire designed for self-completion and measures DVT impact on symptoms and QOL from patients' perspective. It contains 26 items covering patient DVT: symptoms, limitations in daily activities, and psychological impact. Two separate summary scores are produced ranging from 0 to 100; a disease-specific QOL (VEINES-QOL) and venous symptoms (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym, higher scores indicate a better QOL. Instruments were completed at Visits 1 and 2 (Follow-up). Those participants with a VEINES-QOL score increase at Visit 2 in comparison to Visit 1 were counted as having improved.|Vist 2 (Week 8)||||Participants|||Count of Participants
1448994|NCT00858130|Secondary|Number of Study Participants With Improvements in PTS Severity (Villalta Score)|The Villalta PTS scale is based on patient symptoms including cramps, pain, and redness and was used to characterize PTS severity. Points are given for 11 descriptors according to severity from 0 (not present) to 3 (severe) with overall scores ranging from 0 to 33. Higher scores represent more severe disease. A score of ≥ 5 indicated mild PTS; 10-14 moderate PTS; and a score of ≥15, or the presence of a venous ulcer, indicated severe PTS. Those participants with a Villalta score decrease at Visit 2 in comparison to Visit 1 were counted as having improved.|Visit 2 (Week 8)||||Participants|||Count of Participants
1448995|NCT00858130|Secondary|Number of Study Participants Classified as a “Clinical Success”|Clinical success was defined by the patient reporting benefit (moderate improvement of symptoms after having used the device) and an interest and willingness to continue using the device. For this study both legs were measured, but only the more severely affected leg (as determined by higher Villalta score) was used to determine clinical success. Patients were asked the following question: “How much have symptoms improved?” with the following possible responses: “a little;” “moderate;” “a good deal;” “a great deal;” or “a very great deal.”|Visit 2 (Week 8)||||Participants|||Count of Participants
1448996|NCT00858130|Primary|Median Optimal Electrical Stimulation Intensity Level for Largest Benefit in Relief of Symptoms|The VeinoPlus® electrically stimulates leg muscles via motor nerves, causing muscle contractions. Two electrode pads are placed on the skin of the leg. Pad positions can be chosen by the patient, such as (a) both pads on the calf muscle of one leg, (b) one pad on the calf muscle and one on the plantar aspect of the foot of one leg, and (c) a pad posteriorly on each calf. Length of treatment is programmed into the device and is 20 minutes. The device has a variable intensity setting which allows subjects to choose their own level and change the stimulations during the treatment cycle if desired. The intensity ranges from zero to fifty, with zero being no electrical stimulation, and fifty the highest intensity, which carries low quantities of electrical energy (<5 micro coulombs). In this study subjects used the device at any setting, as many times a day as they liked, and varying the placement of the electrodes.|Visit 2 (Week 8)||||mirco coulombs (0 to 50)||Full Range|Median
1448997|NCT00858013|Secondary|HOMA-IR|insulin resistance marker HOMA-IR at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||mg/dL x mIU/L||Standard Deviation|Mean
1448998|NCT00858013|Secondary|C-peptide|c-peptide(uU/mL) at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||uU/mL||Standard Deviation|Mean
1448999|NCT00858013|Secondary|Fasting Glucose|fasting glucose (mg/dL) at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||mg/dL||Standard Deviation|Mean
1449000|NCT00858013|Secondary|HbA1c|HbA1c (%) at 24 months|at 24 months|data of participants who finished 24 months of follow-up|||% HbA1c||Standard Deviation|Mean
1449001|NCT00858013|Primary|The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate|% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)|every 3 months following randomization, for 24 months||||Participants|||Count of Participants
1449003|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]|Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||h*ng/dL||Standard Deviation|Mean
1449004|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)|Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||percent fluctuation in concentration||Standard Deviation|Mean
1449005|NCT00857961|Primary|Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||ng/dL||Standard Deviation|Mean
1449006|NCT00857961|Primary|Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||ng/dL||Standard Deviation|Mean
1449007|NCT00857961|Primary|Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)|Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.|||ng/dL||Standard Deviation|Mean
1449008|NCT00857961|Primary|Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)|Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.|Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment|All participants received all four doses of testosterone MD-lotion.|||hours (h)||Full Range|Median
1449009|NCT00857948|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).||Day 1 up to Day 28 post-application|Adverse events were assess in the Safety (Intent-to-treat) Population.|||Participants|||Number
1449010|NCT00857948|Secondary|Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)|The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.|Day 1 through Day 15 post-application|The level of lice infestation was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of participants|||Number
1449011|NCT00857948|Secondary|Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 8 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of participants|||Number
1449012|NCT00857948|Primary|Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)|Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.|Day 1 through Day 15 post-application|Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.|||Percent of participants|||Number
1449051|NCT00857818|Secondary|Mean Changes in Weight From Baseline||Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1449013|NCT00857896|Secondary|Post-void Residual (PVR) Volume|Volume of urine remaining in the bladder immediately after urination.|Baseline, Week 4, and Week 8 post-dose|Safety Population: all participants who were known to have received study medication; Number of participants analyzed (N) = participants not performing clean intermittent bladder catheterization (CIC); n = participants not performing CIC at specified time point.|||mL||Full Range|Median
1449014|NCT00857896|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 28 and Day 56|PK Concentration|||L/hr||95% Confidence Interval|Mean
1449015|NCT00857896|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||hours||Standard Deviation|Mean
1449016|NCT00857896|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||hours||Standard Deviation|Mean
1449017|NCT00857896|Primary|Maximum Observed Plasma Concentration (Cmax)||Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
1449018|NCT00857896|Primary|Area Under the Plasma Drug Concentration Time Curve (AUC)|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Day 28 and Day 56|Not analyzed due to the limited amount of data available.|||mcg*h/mL||Standard Deviation|Mean
1449019|NCT00857896|Primary|Apparent Volume of Distribution (VC/F)|The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.|Day 28 and Day 56|PK Concentration|||Liters (L)||95% Confidence Interval|Mean
1449020|NCT00857896|Primary|Absorption Rate Constant (Ka)||Day 28 and Day 56|Pharmacokinetic (PK) concentration population: randomized and treated participants who had at least 1 concentration during the study.|||1/hour (hr)||95% Confidence Interval|Mean
1449021|NCT00857857|Secondary|Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA)|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study. The outcome is not assessed.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. A GSK file note, dated 02 April 2009, was used to document that mRNA would no longer be collected from the sputum samples. This was due to the fact that a suitable laboratory could not be identified to carry out the analysis.||||||
1449022|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1449023|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8)|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1449024|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO)|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1449025|NCT00857857|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils|Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||10^4 cells per milliliter of sputum||Geometric Coefficient of Variation|Geometric Mean
1449026|NCT00857857|Secondary|Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period.|Methacholine challenge PC20 data the concentration of methacholine to cause >= 20% decrease (that is change <= -20%) in FEV1 compared with saline [Baseline]) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The PC20 was obtained by linear interpolation (on the log 2 concentration scale) between the lowest concentration of methacholine that caused at least 20% decrease from Baseline and the preceding concentration. The adjusted mean is presented as LSM.|Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||milligrams per milliliter||95% Confidence Interval|Least Squares Mean
1449027|NCT00857857|Secondary|Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Millimoles per liter||Standard Deviation|Mean
1449348|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics."|Day 100|All treated and eligible patients, who were able to complete testing|||percentage of participants|||Number
1449028|NCT00857857|Secondary|Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Total bilirubin and direct bilirubin were also assessed on Day 7 (pre-dose).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
1449029|NCT00857857|Secondary|Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Liver safety parameters (ALT and AST) were also assessed on Day 7 (pre-dose).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||International unit per liter||Standard Deviation|Mean
1449030|NCT00857857|Secondary|Mean Laboratory Values for Albumin and Total Protein|Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Grams per liter||Standard Deviation|Mean
1449031|NCT00857857|Secondary|Mean Laboratory Values for Reticulocytes|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
1449032|NCT00857857|Secondary|Mean Laboratory Values for Mean Corpuscle Volume (MCV)|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Femtoliters||Standard Deviation|Mean
1449033|NCT00857857|Secondary|Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH)|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Picograms||Standard Deviation|Mean
1449034|NCT00857857|Secondary|Mean Laboratory Values for Hematocrit|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Ratio||Standard Deviation|Mean
1449035|NCT00857857|Secondary|Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Grams per liter||Standard Deviation|Mean
1449036|NCT00857857|Secondary|Change From Baseline in FEV1-non Allergen Challenge|Non-allergen challenge FEV1 data was measured on Day 1, 7, 13 and 14. The FEV1 assessments on Day 1 was taken at pre-dose and those on Day 7 was taken post-dose. On Day 13, the pre-allergen challenge FEV1 values was used and on Day 14 the pre-methacholine challenge FEV1 values was used. Absolute change in FEV1 on Day 7, 13 and 14 from pre-dose FEV1 was analyzed separately using a mixed-effects ANOVA model. Period-level Baseline was defined as the difference between the Day 1 pre-dose value and participant-level Baseline for each period, each participant. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value. Post-randomization values refer to assessments performed post dose and after the Baseline assessment. The adjusted mean is presented as LSM.|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1449037|NCT00857857|Secondary|Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. All participants were present at the time of assessment.|||Giga cells per liter||Standard Deviation|Mean
1449038|NCT00857857|Secondary|Change From Baseline in FEV1-allergen Challenge at Each Time Point|A mixed model analysis was performed separately for each planned time point during the allergen challenge on Day 13, from 5 minutes to 10 hour, including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. FEV1 was measured at 5, 10, 15, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours. The adjusted mean is presented as LSM.|Up to Day 13 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Liters||95% Confidence Interval|Least Squares Mean
1449039|NCT00857857|Secondary|Number of Participants With Electrocardiogram (ECG) Findings|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. It was measured on Day 1 (pre-dose and 1 hour post dose) and Day 14 (pre and 1 hour post methacholine challenge). Participants with normal (Nr), abnormal not clinically significant (ANCS) and abnormal clinically significant (ACS) ECG was presented.|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Participants|||Count of Participants
1449065|NCT00857714|Primary|Number of Patients Where Gene Signature Was Obtained.|Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.|Up to 60 days||||participants|||Number
1449040|NCT00857857|Secondary|Mean Values for Heart Rate|Participants were required to rest in the supine position for at least 10 minutes before each reading. Heart rate was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge) and Day 14 (pre and 1 hour post methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Beats per minute||Standard Deviation|Mean
1449041|NCT00857857|Secondary|Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Participants were required to rest in the supine position for at least 10 minutes before each reading. SBP and DBP was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge [pre saline]) and Day 14 (pre and 1 hour post methacholine challenge).|Up to Day 14 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
1449042|NCT00857857|Secondary|Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 17 weeks|All subject population.|||Participants|||Count of Participants
1449043|NCT00857857|Secondary|Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period|Exhaled NO concentration data collected on Day 13 (2 and 12 hours post-dose) and was measured 3 times at each time point. The outcome was not assessed and data not reported.|Day 13 of each treatment period (approximately 17 weeks)|All subject population. The results were not collected for exhaled NO post-dose on Day 13.||||||
1449044|NCT00857857|Secondary|Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period|Exhaled NO concentration data collected on Day 13 (pre-dose) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The adjusted mean is presented.|Day 13 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Parts Per Billion||95% Confidence Interval|Geometric Mean
1449045|NCT00857857|Secondary|EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period.|Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 0-2 hrs post-allergen challenge (minimum EAR) was the minimum value of all the post-(bolus) allergen challenge. Weighted mean EAR was calculated for FEV1 over 0-2 hours post allergen challenge using the linear trapezoidal rule. It was measured up to and including 2 hours (5, 10, 15, 20, 30, 45 minutes and 1, 1.5 and 2 hours). The adjusted mean is presented as LSM.|0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks)|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1449046|NCT00857857|Secondary|LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period.|Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Weighted mean LAR was calculated for FEV1 over 4-10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours) post allergen challenge using the linear trapezoidal rule. To calculate weighted mean LAR, all FEV1 values recorded after the administration of rescue medication have been set to the last recorded FEV1 value prior to the administration of rescue medication. The adjusted mean is presented as Least square mean (LSM).|4-10 hours after allergen challenge on Day 13 of each treatment period|All subject population. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1449047|NCT00857857|Primary|Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period|Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 4-10 hours post allergen challenge was minimum value of all the post-saline time points between 4 to 10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours). The adjusted mean is presented as least square mean (LSM).|4-10 hours after allergen challenge on Day 13 of each treatment period|The all subject population was used which was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
1449048|NCT00857818|Primary|Mean Baseline Fasting Non-HDL Levels||At baseline (Day 1)|All randomized patients who took at least 1 dose of study medication during the treatment period.|||mg/dL||Standard Error|Mean
1449052|NCT00857818|Secondary|Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores|The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.|Baseline to Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1449053|NCT00857818|Secondary|Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count|Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, this study was terminated early, and these data were not summarized.||||||
1449054|NCT00857818|Secondary|Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale|The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1449055|NCT00857818|Secondary|Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline||Baseline and Weeks 4, 8, and 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1449056|NCT00857818|Secondary|Mean Changes From Baseline in Fasting Glucose Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1449057|NCT00857818|Secondary|Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels||Baseline to Week 16|Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.||||||
1449058|NCT00857818|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs|AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.|Baseline to Week 16, continuously|All randomized subjects who took at least 1 dose of study medication during the treatment period.|||Participants|||Number
1449059|NCT00857818|Primary|Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels|Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.|Baseline to Weeks 4, 8, and 16|All randomized patients who took at least 1 dose of study medication during the treatment period. The Last Observation Carried Forward (LOCF) data set included data recorded at a given visit. If no observation was recorded at that visit, data was carried forward from the previous visit. .|||Percentage of change||Standard Error|Mean
1449060|NCT00857792|Primary|Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.||3 months||||% accurately detected perfusion defects|Participants||Number
1449061|NCT00857766|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint|FEV1 is a measure of air flow via spirometry. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.|||milliliters||Standard Error|Mean
1449062|NCT00857766|Secondary|Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint|AIx is a surrogate measure of peripheral (not aortic) arterial resistance and is measured by analysis of the pulse wave at the radial artery. AIx = ([delta P/Pulse Pressure] x 100); delta P is defined by a notch near the peak of the pulse wave. Change from Baseline was calculated as the Endpoint value minus the Baseline Value.|Baseline and the 12-Week Endpoint (up to Week 12)|ITT Population. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.|||% of total height of peak pulse pressure||Standard Error|Mean
1449063|NCT00857766|Primary|Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint|The 12-week Endpoint is defined as the last scheduled measurement of PWV during the 12-week double-blind treatment period (from Visits 3-5; Weeks 4, 8, and 12, respectively), and Baseline is defined as the PWV measure from Visit 2 (Randomization). Change from Baseline was calculated as the Endpoint value minus the Baseline Value. PWV is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the PW along an artery is dependent on the stiffness of that artery.|Baseline and the 12-Week Endpoint (up to Week 12)|Intent-to-Treat (ITT) Population: all participants who were randomized to study drug. The number analyzed at baseline is different from that at the 12-week endpoint due to participant withdrawal. Data are missing for some participants in the ITT Population.|||meters per second (m/s)||Standard Error|Mean
1449064|NCT00857714|Secondary|Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.|Number of patients with toxicity associated with short therapy with lapatinib will be reported.|Up to 60 days||||participants|||Number
1449066|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using CMAI - Long Form Total Score.|"Change from Baseline on the Cohen-Mansfield Agitation Inventory (CMAI) - Long Form total score.~CMAI - Long Form looks specifically at agitated behaviour in patients with cognitive impairment. It is a seven-point rating scale assessing the frequency of up to 29 agitated behaviours, ranging from 1 = Never to 7 = Several times an hour. Rating is based on responses obtained from interviews with the caregiver. The total score ranges from 29 to 203, with a higher score reflecting more frequent behavioural disturbances."|Baseline to Week 24|FAS; OC|||Scores on a scale||Standard Error|Mean
1449067|NCT00857649|Secondary|Efficacy of Memantine on Functioning Using ADCS-ADL - 19 Items Total Score.|"Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item version total score.~ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline to Week 24|FAS; OC|||Scores on a scale||Standard Error|Mean
1449068|NCT00857649|Secondary|Efficacy of Memantine on Global Condition Using CIBIC-plus.|"Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus). Improvement evaluated with reference to Baseline.~CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Baseline to Week 24|FAS; Observed Cases (OC).|||Scores on a scale||Standard Error|Mean
1449069|NCT00857649|Primary|Efficacy of Memantine on Cognition in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the SIB Total Score.|"Change from Baseline in Severe Impairment Battery (SIB) total score.~SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline to Week 24|FAS; LOCF|||Scores on a scale||Standard Error|Mean
1449070|NCT00857649|Primary|Efficacy of Memantine on Behavioural Symptoms in Outpatients With Moderate to Severe Dementia of the Alzheimer's Type Using the NPI - 12 Items Version Total Score.|"Change from Baseline in Neuropsychiatric Inventory (NPI) total score.~NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline to Week 24|"Full-analysis Set (FAS) – all randomised patients on current treatment with an acetylcholinesterase inhibitor (AChEI) who took at least one dose of investigational medicinal product (IMP) and had at least one post-baseline assessment on both co-primary efficacy variables.~Last Observation Carried Forward (LOCF)."|||Scores on a scale||Standard Error|Mean
1449071|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.|From baseline to 28 days|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
1449072|NCT00857623|Secondary|Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.|Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.|From baseline to day 28..|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
1449073|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.|"Affective index= sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
1449074|NCT00857623|Secondary|Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.|"Sensory index= sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index= 0-33 (higher score represents a worse condition).~Change from baseline (measured prior to randomization) to Day 28 was calculated."|From baseline to day 28.|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
1449075|NCT00857623|Secondary|Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” at Day 28.|"Patient Global Impression of Change (PGIC) scale ranges from 1-7, where 1= Very much improved and 7= Very much worse.~Responder= Patient with a response of much improved or very much improved Responder rate= (no. of responders/total no. of patients)*100"|28 days|Per Protocol population (PP)|||Participants|||Number
1449076|NCT00857623|Secondary|Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)|||Participants|||Number
1449077|NCT00857623|Secondary|Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28|Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction ≥30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100|28 days|Per Protocol population (PP)|||Participants|||Number
1449160|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 52|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm/cm||Standard Error|Least Squares Mean
1449078|NCT00857623|Secondary|Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.|Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.|From baseline to 28 days|Per Protocol population (PP)|||Scores on a scale||Standard Deviation|Mean
1449079|NCT00857623|Primary|Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment|"Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).~Mean pain intensity for 5-day baseline period (evening Day -6 to moning Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable."|From baseline to day 28|Per Protocol population (PP)|||Scores on a scale||Standard Error|Least Squares Mean
1449080|NCT00857584|Secondary|Number of Patients With Remission at Week 8.|"Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology|||Participants|||Number
1449081|NCT00857584|Secondary|Number of Patients With Remission at Week 4.|"Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
1449082|NCT00857584|Secondary|Number of Patients With Remission at Week 2.|"Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
1449083|NCT00857584|Secondary|Number of Patients With Remission at Week 1.|"Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
1449084|NCT00857584|Secondary|Number of Patients With Response at Week 8.|"Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
1449085|NCT00857584|Secondary|Number of Patients With Response at Week 4.|"Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
1449086|NCT00857584|Secondary|Number of Patients With Response at Week 2|"Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
1449087|NCT00857584|Secondary|Number of Patients Response at Week 1|"Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms."|week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||Participants|||Number
1449088|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1450869|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population|||Participants|||Number
1449089|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score|HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1449090|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity)|baseline, week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1449091|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1449092|NCT00857584|Secondary|The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1449093|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score|CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology|||score on a scale||95% Confidence Interval|Mean
1449094|NCT00857584|Secondary|The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline. week 8|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1449095|NCT00857584|Secondary|The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 4|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1449096|NCT00857584|Secondary|The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 1|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.|||score on a scale||95% Confidence Interval|Mean
1449097|NCT00857584|Primary|The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)|baseline, week 2|Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. Safety data were analyzed for patients who received at least one dose of study medication.|||score on a scale||95% Confidence Interval|Mean
1449098|NCT00857545|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death due to any cause or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Enrolled and randomized participants. The upper limit of the 95% confidence interval for OS median in arm 1 is not available because the data is not mature enough for estimation at the time of this report.|||Months||95% Confidence Interval|Median
1449099|NCT00857545|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) During Treatment Period|Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.|During treatment period and up to 30 days after stopping the study treatment; up to 83 weeks.|Enrolled and randomized and treated Patients. Grade 3 or worse adverse events for gastrointestinal disorders were significantly associated with treatment arm at significant level of 0.05 by two-sided Fisher’s exact test. The reporting arm 2 had higher proportion of patients with reported grade 3 or worse adverse events.|||participants|||Number
1449134|NCT00857246|Primary|Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab|Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any “down-staging” of T or N stage is considered to be a result of induction therapy and counted as a clinical response.|4 months from the beginning of the induction regimen|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)|||percentage of paticipants|||Number
1449100|NCT00857545|Primary|Progression-free Survival (PFS)|Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.|Every 3 month until 2 years from start of treatment, then every 6 months for 3 years; then annually if patient remains in remission.|Enrolled and randomized participants. 95% two-sided confidence interval|||Months||95% Confidence Interval|Median
1449101|NCT00857532|Secondary|Correlation of Florbetapir SUVR With CSF Biomarker Values|Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables.|50-60 min after injection|Participants were a subset of all subjects enrolled in this study who were also part of an ongoing study looking at the usefulness of CSF biomarkers.|||Correlation Coefficient|||Number
1449102|NCT00857532|Secondary|Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.|Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.|||Correlation Coefficient|||Number
1449103|NCT00857532|Primary|Mean Cortical Amyloid Burden|Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here.|50-60 min after injection|All subjects who were enrolled in the study and received florbetapir scans.|||SUVR||Standard Deviation|Mean
1449104|NCT00857506|Secondary|Correlation of Change in ADAS-Cog and SUVR|Correlation between change from baseline to 36 month ADAS-Cog score and baseline global average SUVR by diagnostic group is provided below. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance. Standard Uptake Value Ratio (SUVR) is the ratio of tracer uptake in the cortex and cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the cortex as compared to the cerebellum whereas scores less than 1 indicate the opposite.|Baseline and 36 months||||Pearson Correlation Coefficient|||Number
1449105|NCT00857506|Secondary|Covariate Adjusted Psychometric Score Change|Change from baseline by diagnostic group in covariate-adjusted psychometric assessment scores at month 36 (LOCF). Assessments included Digit Symbol Substitution (DSS), Clinical Dementia Rating Sum of Boxes (CDR-SOB), Mini-Mental State Examination (MMSE), Wechsler Logical Memory Scale (WLMS) delayed and immediate recall, Category Verbal Fluency (CVF) animals and vegetables, Alzheimer's Disease Clinical Studies Consortium Activities of Daily Living (ADCS ADL) and Geriatric Depression Scale (GDS). The ranges for these scales are as follows: DSS (0-93), CDR-SOB (0-18), MMSE (0-30), WLMS delayed and immediate recall (0-25), CVF animals and vegetables (0-total number of relevant items named in 60 seconds), ADCS ADL (0-78) and GDS (0-15). For all scales except CDR-SOB and GDS a higher score indicates greater cognitive function. For CDR-SOB and GDS a higher score indicates increased dementia or depression, respectively.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Scores on a scale||Standard Error|Mean
1449106|NCT00857506|Secondary|Cognitive Decline in CN and AD Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the CN and AD populations with clinically significant deterioration in ADAS-Cog (≥4) and CDR global score (≥0.5). ADAS-Cog scores (range 0-70) indicate performance on a series of cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Participants|||Number
1449107|NCT00857506|Secondary|Change in ADAS-Cog in CN and AD Subjects|This analysis compared the magnitude of change from baseline in ADAS cognitive subscale (ADAS-Cog) scores between Aβ+ and Aβ- subjects in the CN and AD populations at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (LOCF). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Scores on a scale||Standard Error|Mean
1449135|NCT00857233|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 24|APTS|||percentage of participants|||Number
1449108|NCT00857506|Secondary|Cognitive Decline in MCI Subjects|The key secondary analyses compared the number of Aβ+ and Aβ- subjects in the MCI population with clinically significant deterioration in ADAS-Cog (≥4) and Clinical Dementia Rating (CDR) global score (≥0.5) and conversion in diagnosis from MCI at baseline to AD or Cognitively Normal (CN) at 36 months. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. CDR scores (range 0-3) quantify the severity of the symptoms of dementia where 0 indicates no cognitive impairment and 3 indicates severe dementia. Changes in ADAS-Cog and CDR scores were calculated by subtracting the baseline score from the 36 month score (LOCF).|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Participants|||Number
1449109|NCT00857506|Primary|Change in ADAS-Cog for MCI Subjects|The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (last observation carried forward [LOCF]). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 36 months|Brain amyloid status was determined by baseline florbetapir F 18 PET scans performed in study 18F-AV-45-A05 (NCT00702143).|||Scores on a scale||Standard Error|Mean
1449110|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hematocrit||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||percentage of red blood cells in sample||Standard Deviation|Mean
1449111|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Hemoglobin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||grams per deciliter (g/dL)||Standard Deviation|Mean
1449112|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Estradiol||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
1449113|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||mIU/mL||Standard Deviation|Mean
1449114|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Prostatic Specific Antigen (PSA)||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1449115|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Glucose||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1449116|NCT00857454|Secondary|Change From Baseline MTE08 to MTE09 Follow-up in Fasting Insulin||Day 1, up to Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at endpoint (Day 180) or Follow-Up/Early Withdrawal (Day 190).|||uIU/mL||Standard Deviation|Mean
1449117|NCT00857454|Primary|Change From Baseline MTE08 to MTE09 Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/escar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Day 1, Day 190|Participants enrolled in the study who had a baseline on MTE08 (Day 1) and a measurement at MTE09 endpoint (Day 190).|||units on a scale||Standard Deviation|Mean
1449118|NCT00857415|Secondary|Regional Correlation Analysis|Spearman's rank order correlation of median visual read of the florbetapir-PET image vs. amyloid plaque density assessed post-mortem by quantitative IHC of six individual brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners|||Correlation coefficient||95% Confidence Interval|Number
1449119|NCT00857415|Primary|Specificity Analysis|Specificity of florbetapir-PET scan in younger healthy controls presumed to be negative for amyloid. Specificity results are reported as the number of subjects who had a negative scan based on majority of 3 blinded readers.|50-60 min after injection|Per protocol, 27 subjects who were genetic carriers for ApoE e4 or whose genetic status was unknown were excluded from the analysis|||participants|||Number
1449120|NCT00857415|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median semi-quantitative visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy up to 12 months post-scan|All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners|||Correlation coefficient||95% Confidence Interval|Number
1449146|NCT00857220|Secondary|Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12|The PDSS total score ranges from a low of 0 where the individual is endorsing each item at the lowest level of daytime sleepiness to a high of 32 where the individual is endorsing each item at the highest level of daytime sleepiness.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population|||units on a scale||Standard Deviation|Mean
1449121|NCT00857311|Primary|Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)|"Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site.~Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine."|up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs||||Participants|||Number
1449122|NCT00857311|Secondary|Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen|"Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).~No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious."|Week 30 (4 weeks after boost injection)|No analysis was performed.||||||
1449123|NCT00857311|Secondary|Number of Participants With Systemic and Laboratory Adverse Events (AE)|Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose.|up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs||||Participants|||Number
1449124|NCT00857285|Primary|Mean Change of Sitting dBP From Baseline to Week 12|The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.|Baseline to 12 weeks|Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation.|||mmHg||Standard Error|Mean
1449125|NCT00857272|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|Cleansing was scored with a four point scale used in previous bowel cleansing studies where 4 = “excellent” (no more than small bits of adherent feces/fluid); 3 = “good” (small amounts of feces or fluid not interfering with the exam); 2 = “fair” (enough feces or fluid to prevent a completely reliable exam); 1 = “poor” (large amounts of fecal residue requiring additional cleansing). For the primary efficacy endpoint (preparation success), grades of 4 and 3 were considered a “success” and grades of 2 or 1 were considered a “failure”.|during colonoscopy|The analysis population consists of patients that were randomized and took any portion of the study preparation and who did not discontinue prior to colonoscopy due to a reason of safety or efficacy.|||percent of participants||95% Confidence Interval|Number
1449126|NCT00857259|Secondary|Change in Visual Acuity From Baseline to Week 4 in Patients Treated With Everolimus|Best corrected visual acuity (BCVA) was assessed on both eyes. BCVA measurements were taken in sitting position using Early Treatment Diabetic Retinopathy Study (ETDRs)-like visual acuity testing charts at an initial testing distance specific to test charts. BCVA is measured from the number of letters the patient can read on the eye chart.|Baseline and week 4|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.|||Letters||Standard Deviation|Mean
1449127|NCT00857259|Primary|Change in Central Retinal Thickness From Baseline to Week 4, as Measured by Optical Coherence Tomography (OCT)|Central retinal thickness was assessed by Optical coherence tomography (OCT). The primary thickness endpoint was the mean thickness of the foveal field of the macula map produced by the analysis of the sequence of six radial scans. Foveal field thickness was the average thickness of a circular field with a diameter of 1 mm. OCT images were analyzed by a central reading center.|Baseline and 4 weeks|The Per Protocol Analysis Set (PPAS)consisted of all patients in the Full Analysis Set (FAS)who received study drug, completed the treatment phase of the trial without clinically significant protocol deviations and had non-missing central retinal thickness values for the study eye at both baseline and Day 28.|||µm||Standard Deviation|Mean
1449128|NCT00857246|Secondary|Median Overall Survival (Adjuvant Therpary)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who received at least one cycle of adjuvant therapy|||months||Full Range|Median
1449129|NCT00857246|Secondary|Median Overall Survival (Induction Treatment and Curative Surgery)|This is the length of time from the start of treatment that half of the patients are still alive.|up to 5 years|Patients who completed induction treatment and underwent curative surgery|||months||Full Range|Median
1449130|NCT00857246|Secondary|Safety of the Induction Regimen|This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.|4 months from the beginning of the induction|Patients who had at least a dose of treatment|||participants|||Number
1449131|NCT00857246|Secondary|"Rate of Down-staging From Pre-operative Clinical Staging"|This is defined as the percentage of patients who had a reduction from T3/T4 disease.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)|||percentage of participants|||Number
1449132|NCT00857246|Secondary|Rate of Potentially Curative Surgery|This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).|4 months from the beginning of the induction treatment|patients who underwent surgery|||percentage of participants|||Number
1449133|NCT00857246|Secondary|Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy|This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.|4 months from the beginning of the induction treatment|Evaluable patients (known pre-treatment clinical and post-treatment pathologic stages)|||percentage of participants|||Number
1449217|NCT00856908|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose||||Participants|||Number
1449136|NCT00857233|Secondary|Long-term Efficacy of Memantine on Functioning Using the Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 19-item Version Total Score|"Change from Baseline on the ADCS-ADL 19-item version total score. Analysed by descriptive methods only.~ADCS-ADL- 19 items version for moderate to severe AD will measure patient's functioning. This battery of ADL questions is used here to measure the functional capabilities of patients with dementia. The inventory is done by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Total score is from 0 to 54. The higher score, the lower impairment."|Baseline and Week 24|APTS; OC|||Scores on a scale||Standard Deviation|Mean
1449137|NCT00857233|Secondary|Long-term Efficacy of Memantine on Global Condition Using the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-plus).|"CIBIC-plus. Improvement evaluated with reference to Baseline. Analysed by descriptive methods only.~CIBIC-plus is a global rating that is derived through an independent, comprehensive interview with the patient and caregiver by a rater who is barred from knowledge of all other psychometric test scores conducted as part of this protocol as well as from reported safety data. The rating is made on a 7-point scale ranging from 1 = marked improvement to 7 = marked worsening. A score of 4 indicates no change."|Week 24|APTS; OC|||Scores on a scale||Standard Deviation|Mean
1449138|NCT00857233|Secondary|Long-term Efficacy of Memantine on Cognition Using the Severe Impairment Battery (SIB) Total Score.|"Change from Baseline in the SIB total score. Analysed by descriptive methods only.~SIB is a validated scale used to assess cognitive function in patients with moderate to severe dementia. Items are single words or one-step commands combined with gestures. Nine domains are assessed, and the total score is between 0 and 100. A lower total score reflects the loss of cognitive function."|Baseline and Week 24|APTS; OC|||Scores on a scale||Standard Deviation|Mean
1449139|NCT00857233|Secondary|Long-term Efficacy of Memantine on Behavioural Symptoms Using the Neuropsychiatric Inventory (NPI) - 12 Items Version Total Score.|"Change from Baseline in the NPI total score. Analysed by descriptive methods only.~NPI is a validated scale that assesses behavioural disturbances in patients with dementia. The 12 item version consists of 10 behavioural and 2 neurovegetative areas. It provides both a total score as well as scores for a number of sub-scales. The frequency, severity and caregiver distress for each domain are measured. The NPI is based upon responses obtained from the caregiver. The total score is from 0 to 144. A higher score reflects more frequency and severity of the disturbances."|Baseline and Week 24|APTS; Observed cases (OC)|||Scores on a scale||Standard Deviation|Mean
1449140|NCT00857233|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Baseline to Week 24|Completers from lead-in study 10158 were eligible for this open-label extension study. We analysed the All-patients-treated Set (APTS) - all patients who took at least one dose of investigational medicinal product (IMP)|||participants|||Number
1449141|NCT00857220|Secondary|Change From Baseline in Pediatric Quality of Life Scale|The SF-10™ Health Survey for Children is a 10-item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF-10 physical and psychosocial summary measures were scored such that higher scores indicated more favorable functioning. The Physical Summary Score is computed by summing values for questions 1, 2a, 2b, 3 and 5 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications. The Psychosocial Summary Score is computed by summing questions 4, 6, 7, 8, and 9 and standardizing scores by normalizing to a total possible score of 0-100 with higher scores representing more positive indications.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||units on a scale||Standard Deviation|Mean
1449142|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. TST was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Minutes||Standard Deviation|Mean
1449143|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. NAASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Number of Awakenings||Standard Deviation|Mean
1449144|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)|The sleep questionnaire, a Sponsor produced questionnaire used in previous eszopiclone studies, asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of the subject’s sleep over a predefined time period. WASO was assessed based on the responses to the sleep questionnaire.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Minutes||Standard Deviation|Mean
1449145|NCT00857220|Secondary|Change From Baseline in Conners’ Continuous Performance Test II (CCPT II)|The CCPT-II is a computer-based 14-minute, visual-performance task. During an administration, respondents were required to press the space bar or click the mouse whenever any letter except the target letter appears on the screen. The speed at which the letters were presented varied during the administration. There were 6 blocks, with 3 sub-blocks, each containing 20 trials (letter presentations). The interstimulus intervals (ISIs) were 1, 2, and 4 seconds with a display time of 250 milliseconds. The order in which the different ISIs were presented varied between blocks. Conners’ CCPT-II provides the following measures:% Omissions,% Commissions, Hit Reaction Time, Hit Reaction Time Standard Error,Variability of Standard Error, Detectability (d’), Response Style (beta), Perseverations, Hit Reaction Time Block Change (Vigilance Measure), Hit Standard Error Block Change (Vigilance Measure), Hit Reaction Time ISI change, and Hit Standard Error ISI Change, Confidence Index.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||percentage of score||Standard Deviation|Mean
1449147|NCT00857220|Secondary|Change From Baseline in Child Behavior Checklist (CBCL)|CBCL was completed by parents or guardians who saw the child in home-like settings. It includes several competence items, open-ended items for describing the child's illnesses, disabilities, concerns about the child, best things about the child, and several items to rate behavioral, emotional, and social problems. Responses are recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The checklist contains 120 questions. The standardized score is computed by determining the z-score by subtracting the mean for the subject’s age group and gender from the raw score and then dividing this by the standard deviation for the subject’s age group and gender. Next, multiply the zscore by 15 and then add 100. For activities scale, social scale, school scale, and total competence scale, higher values indicate higher competencies. For Internalizing problems, externalizing problems, and total problems, higher values indicate more problems.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||units on a scale||Standard Deviation|Mean
1449148|NCT00857220|Secondary|Change From Baseline at Month 12 in Subjective Sleep Latency (SL)|Sleep latency is the amount of time it takes to fall asleep after the lights have been turned off.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||Minutes||Standard Deviation|Mean
1449149|NCT00857220|Secondary|Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12|A 7-point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to treat population|||units on a scale||Standard Deviation|Mean
1449150|NCT00857220|Secondary|Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6 to 7 years of age, the Coding Copy Subtest B was used for subjects 8 to 16 years of age, and the DSST was used for subjects 17 years of age. The DSST consists of rows containing small blank squares, each paired with a randomly assigned numbers 1-9. Above the rows is a key that pairs each number with a symbol. The subject must fill in the blank spaces with the matching symbol that is in the key. For the Subcopy tests the subject simply copies the symbol above each empty square. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline and 12 Months (from the 1st dose to the end of study)|Intent to Treat Population|||score||Standard Deviation|Mean
1449151|NCT00857220|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses|The C-SSRS is a physician-completed scale to assess any suicidal ideation and suicidal behavior. The C-SSRS contained questions about suicidal behavior and suicidal ideation. Subjects were placed into categories for suicidal behavior and for suicidal ideation based on their responses to various questions. Any suicidality was defined as suicidal behavior or suicidal ideation. The suicidal behavior categories were determined based on the response to the questions under suicidal behavior (Completed Suicide, Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior).The suicidal ideation categories were determined by examining the response to 5 questions under suicidal ideation (Wish to be Dead, Nonspecific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent).|12 Months|Intent to treat population|||Subjects|||Number
1449152|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Participant Affected||12 Months (from the 1st dose to the end of study)|Intent to treat population|||participants|||Number
1449153|NCT00857220|Secondary|Overall Incidence of Skin Reactions: Number of Events||12 Months (from the 1st dose to the end of study)|Intent to treat population|||Events|||Number
1449154|NCT00857220|Primary|Overall Incidence of Adverse Events||12 Months (from the 1st dose to the end of study)|The intent-to-treat (ITT) population consisted of all enrolled subjects who had taken any study medication. One subject did not receive study medication|||participants|||Number
1449155|NCT00856986|Secondary|Hypoglycaemic Episodes Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 0-52|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis|||episodes|||Number
1449156|NCT00856986|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|weeks 0-26|The Safety Analysis Set included all exposed subjects. An outlier subject from the lira 1.8 group, who experienced an extreme number of minor and symptoms only hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
1449157|NCT00856986|Secondary|Adverse Events From Run-in (Week -12) to Week 52||Run-in (week -12) to Week 52|The Safety Analysis Set included all exposed subjects|||events|||Number
1449158|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmHg||Standard Error|Least Squares Mean
1449159|NCT00856986|Secondary|Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmHg||Standard Error|Least Squares Mean
1449218|NCT00856908|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment||||kg||Standard Deviation|Mean
1449161|NCT00856986|Secondary|Mean Change From Randomisation in Waist to Hip Ratio at Week 26|Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm/cm||Standard Error|Least Squares Mean
1449162|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 52||Week 0, week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm||Standard Error|Least Squares Mean
1449163|NCT00856986|Secondary|Mean Change From Randomisation in Hip Circumference at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm||Standard Error|Least Squares Mean
1449164|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||participants||Standard Error|Least Squares Mean
1449165|NCT00856986|Secondary|Mean Change From Randomisation in Waist Circumference at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||cm||Standard Error|Least Squares Mean
1449166|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (last observation carried forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||kg||Standard Error|Least Squares Mean
1449167|NCT00856986|Secondary|Mean Change From Randomisation in Body Weight at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||kg||Standard Error|Least Squares Mean
1449168|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449169|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449170|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449171|NCT00856986|Secondary|Mean Change From Randomisation in Lipids: Triglycerides at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449172|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 52.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449173|NCT00856986|Secondary|Mean Changes From Randomisation in Cholesterol Lipids at Week 26.|Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449174|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 52.||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449175|NCT00856986|Secondary|Mean Change From Randomisation in Fasting C-peptide at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449176|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||pmol/L||Standard Error|Least Squares Mean
1449177|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Pro-insulin at Week 26.||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||pmol/L||Standard Error|Least Squares Mean
1449178|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 52||Week 0 (Randomisation), Week 52|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.||||||
1449179|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Insulin at Week 26||Week 0 (Randomisation), Week 26|Data on fasting insulin could not be obtained for the insulin detemir+liraglutide 1.8 mg+metformin (Detemir + Lira 1.8 group) treated subjects due to cross-reactivity between insulin detemir and the insulin assay. Data from both goups were therefore not further investigated by ANCOVA why no data is presented for this endpoint.||||||
1449180|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449181|NCT00856986|Secondary|Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26|Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.|Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449182|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 52||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449183|NCT00856986|Secondary|Mean Change From Randomisation in Fasting Plasma Glucose at Week 26||Week 0 (Randomisation), Week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||mmol/L||Standard Error|Least Squares Mean
1449184|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)||Week 0, Week 52|The FAS (Full Analysis Set) includes LOCF of last observation before intensification for randomised Lira 1.8 mg treatment group subjects who were intensified.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1449185|NCT00856986|Secondary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)||Week 0, Week 52|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1449186|NCT00856986|Primary|Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.||Week 0 (Randomisation), week 26|The FAS (Full Analysis Set) using LOCF (Last Observation Carried Forward) is all randomised subjects with at least one of any efficacy value after the randomisation visit (baseline)|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1449187|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Hours)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population|||Hours||Standard Error|Least Squares Mean
1449188|NCT00856973|Secondary|Change in School Tardiness/Attendance Reports at Week 12 (Days)|School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.|Baseline (Day 0) to Week 12|Intent to treat population|||Days||Standard Error|Least Squares Mean
1449189|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective Number of Awakenings After Sleep Onset (NAASO)|||Number of Awakenings||Standard Error|Least Squares Mean
1449190|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).|The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children’s health-related quality of life. The scale asked questions about the child’s physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Pediatric Quality-of-Life Scale (Short Form-10)|||units on a scale||Standard Error|Least Squares Mean
1449191|NCT00856973|Secondary|Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.|These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score|||Score||Standard Error|Least Squares Mean
1449219|NCT00856908|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||beats/min||Standard Deviation|Mean
1449192|NCT00856973|Secondary|Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.|The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score|||units on a scale||Standard Error|Least Squares Mean
1449193|NCT00856973|Secondary|Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population|||Minutes||Standard Error|Least Squares Mean
1449194|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|Actigraphy population which included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population|||Minutes||Standard Error|Least Squares Mean
1449195|NCT00856973|Secondary|Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.|A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.|Baseline (Day 0) to Week 11|The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population|||Minutes||Standard Error|Least Squares Mean
1449196|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective Total Sleep Time|||Minutes||Standard Error|Least Squares Mean
1449197|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)|A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined Total Sleep Time|||Minutes||Standard Error|Least Squares Mean
1449198|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).|A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined of Awakenings After Sleep Onset|||Number of Awakenings after sleep onse||Standard Error|Least Squares Mean
1449199|NCT00856973|Secondary|Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)|A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 PSG defined sleep efficiency|||percentage of SE||Standard Error|Least Squares Mean
1449200|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 subjective WASO|||Minutes||Standard Error|Least Squares Mean
1449201|NCT00856973|Secondary|Change From Baseline to Week 12 in Subjective SL (Sleep Latency)|A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject’s sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Subjective sleep latency|||Minutes||Standard Error|Least Squares Mean
1449202|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.|The Conners’ 3 –Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners’ 3 –Parent Short Form was a subset of items from the full-length form, and included the Conners’ 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 Conners’ ADHD Inattention rating scale|||units on a scale||Standard Error|Least Squares Mean
1449203|NCT00856973|Secondary|Change From Baseline in CGI-Child at Week 12|The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject’s assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Child|||Units on a scale||Standard Error|Least Squares Mean
1449204|NCT00856973|Secondary|Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12|The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject’s parent or caregiver and represented their assessment of severity and improvement in the subject’s symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).|Baseline (Day 0) to Week 12|Intent to treat population with Week 12 CGI Improvement from Parent/Caregiver|||Units on a scale||Standard Error|Least Squares Mean
1449205|NCT00856973|Secondary|Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)|A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Change from BL at Week 12 in WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.|Baseline (Day 0) to Week 12|Intent to treat population with both baseline and Week 12 WASO|||Minutes||Standard Error|Least Squares Mean
1449206|NCT00856973|Primary|Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).|A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject’s sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.|Baseline (Day 0) to Week 12|Intent to treat (ITT) population with both baseline and week 12 LPS. ITT refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.|||minutes||Standard Error|Least Squares Mean
1449207|NCT00856934|Secondary|Pain|Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.|Post operative day 5||||VAS Pain Score||Standard Deviation|Mean
1449208|NCT00856934|Primary|Complete Wound Healing|Time required for complete epithelialization in days|Post operative day 5 and every other day thereafter||||Days||Standard Deviation|Mean
1449209|NCT00856908|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment||||relative change in percent||95% Confidence Interval|Least Squares Mean
1449210|NCT00856908|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100|Baseline is the day before first dose, end of treatment is last day of treatment||||relative change in percent||95% Confidence Interval|Least Squares Mean
1449211|NCT00856908|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in an ANCOVA model, using treatment as fixed factor and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent. Changes in percent have been obtained by subtraction by 100.|Baseline is the day before first dose, end of treatment is last day of treatment||||relative change in percent||95% Confidence Interval|Least Squares Mean
1449212|NCT00856908|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment||||L/h||Full Range|Mean
1449213|NCT00856908|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the evening dose last day of treatment||||h||Full Range|Mean
1449214|NCT00856908|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment||||h||Full Range|Median
1449215|NCT00856908|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured following the morning dose last day of treatment||||umol/L||95% Confidence Interval|Geometric Mean
1449216|NCT00856908|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment||||umol*h/L||95% Confidence Interval|Geometric Mean
1449222|NCT00856843|Secondary|Mean Change in Serum Chemistry (mEq/L)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days||||mEq/L||Standard Deviation|Mean
1449223|NCT00856843|Secondary|Mean Change in Serum Chemistry (mg/dL)|Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw.|up to 15 days||||mg/dL||Standard Deviation|Mean
1449224|NCT00856843|Secondary|Subject Symptom Scores|Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing).|2 days||||units on a scale||Standard Deviation|Mean
1449225|NCT00856843|Secondary|Assessment of Residual Fluid - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449226|NCT00856843|Secondary|Assessment of Residual Fluid - Descending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449227|NCT00856843|Secondary|Assessment of Residual Fluid - Transverse Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449228|NCT00856843|Secondary|Assessment of Residual Fluid - Ascending Colon|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449229|NCT00856843|Secondary|Assessment of Residual Fluid - Cecum|The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449230|NCT00856843|Secondary|Assessment of Residual Stool - Sigmoid Colon/Rectum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449231|NCT00856843|Secondary|Assessment of Residual Stool - Descending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449232|NCT00856843|Secondary|Assessment of Residual Stool - Transverse Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449233|NCT00856843|Secondary|Assessment of Residual Stool - Ascending Colon|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449234|NCT00856843|Secondary|Assessment of Residual Stool - Cecum|The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.|2 days||||percentage of participants|||Number
1449235|NCT00856843|Primary|Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale|Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.|2 days||||percentage of participants|||Number
1449236|NCT00856830|Secondary|Progression Free Survival|Using the Response Evaluation Criteria in Solid Tumors (RECIST 2000), progression is defined as 20% or greater increase from the baseline tumor parameters or new lesions.|7 months||||months||95% Confidence Interval|Median
1449237|NCT00856830|Primary|Number of Patients With Adverse Events - Phase II|The degree of toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3.|9 weeks||||participants|||Number
1449238|NCT00856830|Primary|Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I|The determination of the dose limiting toxicity as defined by The National Cancer Institute Common Toxicity Criteria version 3 as follows: grade 4 neutropenia >5 days; grade 3/4 febrile neutropenia; grade 4 thrombocytopenia; or grade >2 non-hematologic toxicities (except for nausea/vomiting, alopecia, or fatigue).|9 weeks||||participants|||Number
1449239|NCT00856791|Secondary|Number of Adverse Events|The number of adverse events and their severity rating will be classified according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0.|6 months||||Adverse event|||Number
1449240|NCT00856791|Primary|Progression Free Survival|Progression-free survival, defined as the number of days from the first day of study drug dosing to the day of documented disease progression or death, as assessed using RECIST (Response Evaluation Criteria in Solid Tumors) guidelines according to Therasse P, Arbuck SF, Eisenhauer EA, et al. (2000) J Natl Cancer Inst. 92:205-216. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 months||||day|||Number
1449241|NCT00856778|Secondary|Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra||At implant||||percentage of responses|||Number
1449242|NCT00856778|Secondary|Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies||At implant||||percentage of responses|||Number
1449243|NCT00856778|Secondary|Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward||At implant||||percentage of responses|||Number
1449244|NCT00856778|Secondary|Assess Change in Pad Use||12 months post-implant||||pads/24 hours||Standard Deviation|Mean
1449245|NCT00856778|Secondary|Assess Change in Pad Use|Patients reported the average number of pads used in a 24 hour period over the 4 weeks prior to the assessment.|Baseline|There are 97 subjects with outcome 9 (baseline pad use). Of the 98 subjects implanted, one is missing the baseline assessment of pad use.|||pads/24 hours||Standard Deviation|Mean
1449262|NCT00856661|Secondary|Modified Ranking Scale Score (Using the Ordinal Scale)|Please see outcomes measure one for detailed description of the mRS scale|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Scores on a scale||Standard Error|Least Squares Mean
1449246|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant||||units on a scale||Standard Deviation|Mean
1449247|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 7 (Urinary function at baseline). Of the 98 subjects implanted, 1 is missing the baseline Urinary Function assessment.|||units on a scale||Standard Deviation|Mean
1449248|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|12 months post implant||||units on a scale||Standard Deviation|Mean
1449249|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother|The UCLA-RAND Incontinence Index is from a section within the RAND 36-item Health Survey v2 (SF-36 v2) and UCLA Prostate Cancer Index and measures a patient’s urinary habits over the 4 weeks prior to questionnaire completion and consists of 6 questions. Two scores are produced, the Urinary Bother and Urinary Function scores. The Urinary Bother score ranges from 0 to 100 with lower scores indicating worse symptoms of urinary bother. The Urinary Function score ranges from 0 to 100 with lower scores indicating worse urinary function.|Baseline|There are 97 subjects with outcome 5 (Urinary bother at baseline). Of the 98 subjects implanted, 3 are missing the baseline Urinary Bother assessment.|||units on a scale||Standard Deviation|Mean
1449250|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|12 months post implant|There are 73 subjects with outcome 4 (ICIQ at 12 months). Of the 74 subjects with 12 months follow-up, 1 is missing the 12 month ICIQ assessment.|||units on a scale - ICIQ Score||Standard Deviation|Mean
1449251|NCT00856778|Secondary|Assess Change in Subject Satisfaction Through ICIQ|The ICIQ-UI Short Form (International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form) is a brief self-assessment instrument applicable to all incontinent patients worldwide that measures the severity of urinary incontinence. The score ranges from 0 to 21 with higher number indicative of worse Urinary Incontinence severity.|Baseline|There are 95 subjects with outcome 3 (ICIQ at baseline). Of the 98 subjects implanted, 3 are missing the baseline ICIQ assessment.|||units on a scale - ICIQ Score||Standard Deviation|Mean
1449252|NCT00856778|Primary|Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).|"Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = <12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: >50% responding very much better or much better."|12 months|"The study was not fully enrolled and therefore underpowered for the planned analyses.~There are 71 subjects with outcome 2 (pad weight endpoint). Of the 74 with 12 months follow-up, 3 are missing the pad weight improvement assessment."|||% of subjects successful||95% Confidence Interval|Number
1449253|NCT00856778|Primary|Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)|"Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: >50% responding very much better or much better."|12 months post implant|The study was not fully enrolled and therefore underpowered for the planned analyses.|||% of subjects successful||95% Confidence Interval|Number
1449254|NCT00856739|Primary|Cartilage Thickness|Medial/lateral thickness ratio|baseline or first and only visit.|Overweight and obese were combined based on similarities found in literature. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.|||mm/mm||Standard Deviation|Mean
1449255|NCT00856739|Primary|Gait Knee Adduction Moment||baseline or first and only visit.|Obese were compared to healthy weight subjects. No overweight subjects were used in this analysis. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.|||percent body weight (N)*height (m)||Standard Deviation|Mean
1449256|NCT00856726|Secondary|Fractional Excretion of Calcium|change in urinary fractional excretion of calcium from baseline to six hours|six hours|adult volunteers|||percentage of fractional excretion||Standard Deviation|Mean
1449257|NCT00856726|Secondary|Parathyroid Hormone|change in parathyroid hormone from baseline to six hours|six hours|adult volunteers|||pg/ml||Standard Deviation|Mean
1449258|NCT00856726|Secondary|Serum Calcium|change in serum calcium from baseline to six hours|six hours|adult volunteers|||mg/dL||Standard Deviation|Mean
1449259|NCT00856726|Secondary|Serum Phosphorus|change in serum phosphorus from baseline to six hours|six hours|adult volunteers|||mg/dL||Standard Deviation|Mean
1449260|NCT00856726|Secondary|Fibroblast Growth Factor 23|The change in fibroblast growth factor 23 concentrations from baseline to six hours|six hours|adult volunteers|||relative units (RU)/ml||Standard Deviation|Mean
1449263|NCT00856661|Secondary|Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)|Please see outcomes measure one and two for detailed description of the scales|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Percentage of participants|||Number
1449264|NCT00856661|Secondary|National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)|The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.|90 days|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Percentage of participants|||Number
1449265|NCT00856661|Primary|Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)|The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient’s function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke|Day 90|Two and three patients from the desmoteplase and placebo group, respectively, had no valid functional assessment done. Hence, the full analysis set consisted of 124 and 128 patients, respectively.|||Percentage of participants|||Number
1449266|NCT00856635|Secondary|To Evaluate Changes on Additional OCT Parameters and Other Visual Function and Clinical Parameters.||6 months|Enrollment did not meet expectations, and target sample sizes were not met. As a results, the secondary outcome was not analyzed. There were no data collected for this outcome; there is no data to analyze.||||||
1449267|NCT00856635|Primary|Retinal Nerve Fiber Layer Thickness at Baseline and Month 6|Axonal loss in the optic nerve (due to optic neuritis) was assessed by measuring retinal nerve fiber thickness of the affected eye using optical coherence tomography (OCT) at Baseline and Month 6.|Baseline and Month 6|The modified ITT intent-to-treat (mITT) analysis set included all patients who had been randomized to the study, received at least one dose of study drug, had a baseline OCT evaluation, and had at least one non-missing post-baseline OCT evaluation.|||µm||Standard Deviation|Mean
1449268|NCT00856609|Secondary|Body Weight|Mean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.|5 weeks||||kg||Standard Deviation|Mean
1449269|NCT00856609|Primary|Twenty-four-hour Energy Expenditure|Change of twenty-four-hour energy expenditure between at Day 5 at baseline assessment and at Day 11 two days after starting study medication between the exenatide and placebo groups|Day 5 and Day 11||||kcal/day||Standard Deviation|Mean
1449270|NCT00856609|Primary|Energy Intake|Mean of 3-day food intake change between 3 days (Day 6-7-8) at baseline assessment and 3 days (Day 12-13-14) during the intervention period between the exenatide and placebo groups|Day 6-7-8 (at baseline) and Day 2-13-14 (3 days after starting study intervention)||||kcal/day||Standard Deviation|Mean
1449271|NCT00856583|Secondary|Number of Participants With Discontinuation of Treatment for Any Reason Other Than Study Closure|The analysis was based on time from start of study drug until stop of study drug for any reason other than sponsor closure of the study|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
1449272|NCT00856583|Secondary|Number of Participants With Hospitalisations, Excluding Hospitalisations Related to the Primary Psychiatric Disease|The analysis was based on time from start of study drug to first hospitalisation during the WRT+30 days period|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
1449273|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - MedDRA|The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
1449274|NCT00856583|Secondary|Number of Participants With Suicide Attempts (Fatal and Non-fatal) - ISC|"The analysis was based on all suicides and suicide attempts from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
1449275|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
1449346|NCT00856388|Secondary|1 yr Extenstive Chronic GVHD|"1 yr Extensive Chronic GVHD~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to 4.5 years|All treated and eligible who survived to day 100 and were eligible to get chronic GVHD|||percentage of participants||95% Confidence Interval|Number
1449276|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon MedDRA terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
1449277|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - MedDRA|The analysis was based on all deaths from the WRT+30 days period using the classification based upon the Medical Dictionary for Regulatory Activities (MedDRA) terminology, that is, as reported by the investigator|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
1449278|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Other Than Cardiac Deaths and Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
1449279|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Completed Suicides - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months||||participants|||Number
1449280|NCT00856583|Primary|Second Primary Outcome: Number of Participants With Cardiac Events, Including Arrhythmias, Requiring Hospitalisation|Second primary endpoint: a serious adverse event where the patient was hospitalised and for which the Independent Safety Committee (ISC) classified the event as a cardiac event with documented arrhythmia. The analysis of this outcome was not performed due to low number of events. The presented analysis is a replacement analysis using all cardiac events, including arrhythmias, that required hospitalisation|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
1449281|NCT00856583|Secondary|Cause-specific Mortality: Number of Participants With Cardiac Deaths - ISC|"The analysis was based on all deaths from the WRT+30 days period using the classification performed by the ISC.~The ISC reviewed and classified those adverse events which resulted in death or hospitalisation or were possible suicide attempts and this review was blinded to exposure. The definition of cardiac death was intentionally wide; sudden or unexplained deaths were assumed to be cardiac if there was no non-cardiac explanation. To ensure consistent evaluation and classification, the ISC decided a priori to classify all instances of self harm as possible suicide."|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
1449282|NCT00856583|Primary|Number of Participants With All-cause Mortality|The analysis was based on all deaths from the Whole Randomised Treatment (WRT)+30 days period and the Only Randomised Treatment (ORT) period, respectively|As study design allowed patients to continue study drug until the study was closed, many patients were followed for several years, with an overall median time period of approximately 14 months|The analysis population included all patients who took at least one dose of study drug.|||participants|||Number
1449283|NCT00856557|Secondary|Rate of Contextual Planning|Proportion of patient encounters in which the physician's plan of care addressed contextual factors identified in the audio recordings|During initial patient recordings||||proportion of physician's patients||Standard Deviation|Mean
1449284|NCT00856557|Secondary|Rate of Contextual Probing|Proportion of encounters in which physician probed contextual red flags expressed by patients and identified via audio recordings.|During initial patient recordings||||proportion of physician's patients||Standard Deviation|Mean
1449285|NCT00856557|Primary|Health Outcome Improvement Rate|A target health outcome improvement for each patient is prospectively defined at the first visit in which a contextual red flag is noted. The study outcome is what proportion of a physician's patients achieve their target health outcome improvement as documented in the medical record at 9 months post first visit.|After 9 months of the recorded visit||||proportion of physician's patients||Standard Deviation|Mean
1449286|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449287|NCT00856544|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449288|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for given parameters for each group respectively.|||hours per day||Standard Deviation|Mean
1449289|NCT00856544|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||hours per day||Standard Deviation|Mean
1449290|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.|||days||Standard Deviation|Mean
1449291|NCT00856544|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||days||Standard Deviation|Mean
1449292|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure for given parameters for each group respectively.|||events||Standard Deviation|Mean
1449293|NCT00856544|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||events||Standard Deviation|Mean
1449294|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.|||units on a scale||Standard Deviation|Mean
1449295|NCT00856544|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449304|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1449296|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.|||units on a scale||Standard Deviation|Mean
1449297|NCT00856544|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449298|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
1449299|NCT00856544|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Patient global assessment of arthritis: participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|2 weeks|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
1449300|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449301|NCT00856544|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449302|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449303|NCT00856544|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449343|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Subject Assessment|"The first visit onset of efficacy as measured by subject assessment. Onset is determined by a yes/no answer to the question Since being injected, have you noticed any effect on the appearance of your frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study|||Number of Days||Standard Deviation|Mean
1449305|NCT00856544|Secondary|Medical Outcome Study (MOS) Sleep Scale at Month 12|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449306|NCT00856544|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||participants|||Number
1449307|NCT00856544|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449308|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for the measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449309|NCT00856544|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS population included participants who received at least 1 dose of study medication. Here, 'n' is signifying those participants who were evaluable for the measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449310|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
1449311|NCT00856544|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
1449312|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
1449313|NCT00856544|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
1449314|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mm||Standard Deviation|Mean
1449315|NCT00856544|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
1449316|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449317|NCT00856544|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1449318|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6, 12|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).||||||
1449319|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).||||||
1449320|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449321|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3, 6|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449322|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449323|NCT00856544|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1449347|NCT00856388|Secondary|Acute GVHD Grade III-IV|"Acute GVHD grade III-IV~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Up to day 100|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1449324|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1449325|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
1449326|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1449327|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
1449328|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12|FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
1449329|NCT00856544|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3, 4.5, 6|FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.|||percentage of participants|||Number
1449330|NCT00856544|Primary|Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1449331|NCT00856544|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Here ‘n’ is number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449344|NCT00856414|Primary|The First Visit Onset of Efficacy as Measured by Physician Assessment|"The first visit onset of efficacy as measured by physician assessment. Onset is determined by a yes/no answer to the question Since injecting the patient, have you noticed any effect on the appearance of the patient's frown lines (lines between the eyebrows)? at days 2, 3, 4, 7, and 14."|14 Days|Intent to Treat defined as all patients who started the study|||Number of Days||Standard Deviation|Mean
1449332|NCT00856544|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI) method.|||percentage of participants|||Number
1449333|NCT00856518|Primary|Swallow-related Quality of Life (SWAL-QOL)|The SWAL-QOL is a validated and standardized tool that measures burden; symptom status including pharyngeal, oral, and saliva; fear; and mental health subdomains. Responses are determined according to an ordinal scale where 1 equals a severe problem and 5 equals no problem. The SWAL-QOL provides an overall score as well as subscale scores. Subjects rate quality of life as follows (expressed as percentage of the possible perfect score): little to no impact (81% - 100%), mild impact (61% - 80%), moderate impact (41% - 60%), severe impact (21% - 40%), and profound impact (0% - 20%).|at baseline and after 5-week of EMST exercise|Out of the total 42 recruited study participants, ten either did not show up for the SWAL-QOL test or only partially answered the questionnaire. Thus, 32 remaining participants (n = 19 for EMST, and n = 13 for Sham) were reported.|||percentage of possible perfect score||Standard Deviation|Mean
1449334|NCT00856518|Primary|Penetration-Aspiration Scale Score|"The Penetration-Aspiration Scale (PAS) was used to measure swallow safety. PAS is an 8 point ordinal scale for quantification of penetration and aspiration. PAS measures the depth to which material enters the airway and if the material is expelled following penetration or aspiration. Categorical groupings of PAS scores include normal to mild (1-2), moderate (3-5) and severe (6-8, indicating that material has passed into the lower airway). These PAS scores may be useful in denoting clinically significant changes (e.g. moderate to mild) resulting from treatment or disease progression. The following table reports the percentage of participants (out of the respective total group participants in EMST and Sham) with changed PAS score of 1 point or more (improving or worsening) and without PAS score changes from pre- to post treatment. The data represent an exploratory quantification without statistical analysis."|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 8 failed to complete the PAS test either at baseline or post training testing. Therefore, 34 subjects were reported for the PAS test (n = 20 for EMST, n = 14 for sham).|||percentage of group participants|||Number
1449335|NCT00856518|Primary|Maximum Expiratory Pressure (MEP)|Expiratory pressure generating capacity assessed via handheld manometer.|at baseline and again after 5-week EMST exercise|Out of the 42 recruited patients, 6 withdrew following the baseline MEP testing, citing travel or loss of interest as the reason. Therefore, 36 subjects were reported for the MEP test (n = 20 for EMST, n = 16 for sham).|||cm H2O||Standard Deviation|Mean
1449336|NCT00856492|Secondary|Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 28 weeks|All participants receiving at least some protocol treatment|||Participants|||Number
1449337|NCT00856492|Secondary|Event-free Survival|Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.|Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab|||participants|||Number
1449338|NCT00856492|Secondary|Overall Survival|Time from registration to death due to any cause|Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab|||deaths|||Number
1449339|NCT00856492|Primary|Number of Patients With Pathological Complete Response Rate|Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.|pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)|Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab|||Participants|||Count of Participants
1449340|NCT00856414|Secondary|Percentage of Patients Reporting Self-Perception of Age (SPA)|"Percentage of patients reporting their SPA. SPA is measured by a questionnaire. Patients were asked to compare their facial appearance to their current age. Response options were Looking younger, Looking current age, and Looking older. Results for each response are presented for Baseline and Day 14."|Baseline, Day 14|Intent to Treat defined as all patients who started the study|||Percentage of patients|||Number
1449341|NCT00856414|Secondary|Change From Baseline in Patient Satisfaction as Measured by Facial Line Outcome (FLO) Questionnaire Score|Change from baseline in patient satisfaction as measured by FLO questionnaire comprised of 11 items that assess subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question is scored on a 11-point scale (0=not at all, 5=somewhat, 10=very much) and the sums are converted to the total FLO score. The minimum total FLO score is 0 (worst) and the maximum total FLO score is 100 (best). The total FLO score was calculated at baseline and Day 14. A positive number change from baseline indicates an improvement.|Baseline, Day 14|Intent to Treat defined as all patients who started the study|||Scores on a Scale||Standard Deviation|Mean
1449342|NCT00856414|Secondary|Average Subject Assessment Score in Improvement of Appearance of Frown Lines|Average subject assessment score in improvement of appearance of frown lines (lines between the eyebrows) as measured by a 7-point scale (1=very much improved and 7=very much worse)on a daily basis. The average scores over the 1st diary week (1-7 days) and the 2nd diary week (8-14 days) are presented.|14 Days|Intent to Treat defined as all patients who started the study|||Scores on a Scale||Standard Deviation|Mean
1449345|NCT00856388|Secondary|3 yr Overall Survival|3 yr Overall Survival estimated using the Kaplan-Meier method.|Up to 4.5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1449349|NCT00856388|Secondary|Rate of Complete Donor Chimerism - Blood|"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics."|Day 30|All treated and eligible patients, who were able to complete testing|||percentage of participants|||Number
1449350|NCT00856388|Secondary|Median Time to Platelet Engraftment|"Median Time to Platelet Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Day 100|All treated and eligible patients|||Days||Full Range|Median
1449351|NCT00856388|Secondary|Median Time to ANC Engraftment|"Median Time to ANC Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals."|Days 30|All treated and eligible patients|||Days||Full Range|Median
1449352|NCT00856388|Primary|Day 100 TRM|Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided.|First 100 days|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
1449353|NCT00856349|Secondary|Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization|Characterization of shock reduction programming utilization by subject characteristics and geographical regions|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.|||percentage of participants|||Number
1449354|NCT00856349|Secondary|Barriers to Utilization of Shock Reduction Programming|Characterization of barriers to physician utilization of shock reduction programming|24 months follow-up visit|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||% of subjects not programmed to target|Participants||Number
1449355|NCT00856349|Secondary|Actions Taken Following a Shock|Characterization of actions taken by the subject immediately following a device shock|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||percentage of subjects with shocks|Participants||Number
1449356|NCT00856349|Secondary|Reasons for Inappropriate Shocks|Reasons for inappropriate shocks observed during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||percentage of inappropriate shocks|Participants||Number
1449357|NCT00856349|Secondary|Lead Integrity Alert (LIA) Performance|Causes for LIA triggers reported during the study|Overall study (20 months on average)|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.|||percentage of subjects with LIA triggers|Participants||Number
1449358|NCT00856349|Primary|Change in Shock Reduction Programming Adoption|"Change in percentage of subjects programmed to evidence-based target from baseline (pre-TPR distribution) to last follow-up (post-TPR distribution).~Shock-reduction programming parameters:~LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.~SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.~VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.~VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.~Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.~PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds."|Overall study (20 months on average)|Subjects with paired baseline and follow-up programming data|||percentage of participants|||Number
1449359|NCT00856323|Secondary|Post-Exposure Prophylaxis Medication Adherence|Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed).|28-days|35 participants initiated PEP|||proportional medication adherence||Inter-Quartile Range|Median
1449360|NCT00856323|Secondary|HIV-related Sexual Risk Behaviors in Previous 30 Days.|Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days.|3-months after baseline|53 enrolled and 2 were withdrawn.|||episodes||Standard Deviation|Mean
1449361|NCT00856323|Secondary|Description of Incident STI Infections.|Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia.|Baseline and 3-months|53 enrolled and 2 were withdrawn.|||Proportion of Participants||Full Range|Mean
1449362|NCT00856323|Primary|Self-reported Methamphetamine Use in Previous 30 Days.|Mean number of days (of the past 30) of methamphetamine use.|3-months after baseline|53 enrolled and 2 were withdrawn.|||days||Standard Deviation|Mean
1449363|NCT00856297|Secondary|Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.|28 days postvaccination|Analysis was done on safety population - subjects who received vaccination with MenACWY-CRM conjugate vaccine, provided post-baseline safety data and provide safety follow-up information for any period during the 28 day follow-up.|||subjects|||Number
1449364|NCT00856297|Secondary|Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator|Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.|Day 1 to 5 years|Analysis was done on safety follow-up population - subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases.|||subjects|||Number
1449365|NCT00856297|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events|Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.|Day 1 to Day 7|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||subjects|||Number
1449397|NCT00856180|Primary|Grade 3-5 Gastrointestinal Perforation|All grade 3-5 gastrointestinal perforation events based on CTCAEv3 as reported on case report forms.|Assessed each cycle/3 weeks throughout treatment from time of first dose and up to day 30 post-treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.|||proportion of participants||90% Confidence Interval|Number
1449366|NCT00856297|Secondary|Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.|||titers||95% Confidence Interval|Geometric Mean
1449367|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine|Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|2 years postvaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
1449368|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine|Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|1 month post booster vaccination|Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
1449369|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination|Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.|||titers||95% Confidence Interval|Geometric Mean
1449370|NCT00856297|Secondary|Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8|Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.|day 1|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
1449371|NCT00856297|Secondary|hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.|||titers||95% Confidence Interval|Geometric Mean
1449372|NCT00856297|Secondary|Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
1449373|NCT00856297|Primary|Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine|Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.|21 months, 3 years and 5 years postvaccination|Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.|||percentages of subjects||95% Confidence Interval|Number
1449374|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104|The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 104|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward was used (LOCF).|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1449375|NCT00856284|Secondary|Change From Baseline in Body Weight Over Time|LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.|Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, LOCF was used.|||kg||Standard Error|Least Squares Mean
1449376|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%|Percentage of participants with HbA1c ≤ 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1449558|NCT00855413|Secondary|Maximum Etravirine Exposure in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
1449377|NCT00856284|Secondary|Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%|The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.|Weeks 26, 52, 78, and 104.|Full analysis set. Participants who did not complete the scheduled Week 26, Week 52, Week 78 or Week 104 visit were assessed based on their response at the time of discontinuation.|||percentage of participants|||Number
1449378|NCT00856284|Secondary|Change From Baseline in Fasting Plasma Glucose Over Time|The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.|Full analysis set, which included all randomized patients who received at least 1 dose of double-blind study drug who had a Baseline assessment and at least 1 post-baseline assessment for FPG. LOCF was used.|||mg/dL||Standard Error|Least Squares Mean
1449379|NCT00856284|Secondary|Change From Baseline in Glycosylated Hemoglobin at Other Time Points|The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.|Per-protocol set; LOCF was used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1449380|NCT00856284|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.|Baseline and Week 52|The Per-protocol set included all randomized patients who took at least 1 dose of double-blind study drug, with a Baseline assessment and at least 1 post-baseline assessment for that variable and who had no major protocol violations. Last observation carried forward (LOCF) was used.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
1449381|NCT00856245|Secondary|Progression Free Survival (PFS) and Overall Survival (OS)|Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.|up to 60 months|Of the 14 patients that had harvestable cells, 3 chose to delay transplant. The remaining 11 patients underwent Autologous stem cell transplantation (Auto-SCT).|||months||Full Range|Median
1449382|NCT00856245|Primary|Rate of PCR Negativity|Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.|up to 7 days|21 patients were initially enrolled; 2 were withdrawn after signing informed consent per physician decision. Of the remaining 19: 5 did not have harvestable stem cells; 14 completed stem cell collection and PCR evaluation.|||Participants|||Count of Participants
1449383|NCT00856232|Primary|Time to Relief (Min)|Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache.|study duration||||Minutes||Standard Deviation|Mean
1449384|NCT00856232|Secondary|Length of Stay in the Emergency Department(Min)|Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department.|Study duration||||Minutes||Standard Deviation|Mean
1449385|NCT00856206|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. Flare days were counted up to Week 16, regardless of whether or not the flares occurred during the treatment period.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flare Days||Standard Deviation|Mean
1449386|NCT00856206|Secondary|Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
1449387|NCT00856206|Secondary|Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|FAS that included all randomized participants who received any study medication, and was based on the treatment allocated by the IVRS at randomization (as randomized).|||percentage of participants|||Number
1449438|NCT00855738|Secondary|Percent of Participants Reaching Monotherapy|Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study.|Baseline through Month 6 (or end of study)|FAS; LOCF. N=number of participants who started on bitherapy.|||percent of partipants||95% Confidence Interval|Number
1449388|NCT00856206|Secondary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication, and was based on the treatment allocated by the Interactive voice response system (IVRS) at randomization (as randomized). Here, number of participants analyzed=participants with available data for this endpoint.|||Gout flares||Standard Deviation|Mean
1449389|NCT00856206|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 20|Safety analysis set that included all participants who received any study drug and safety analyses were based on the treatment received.|||percentage of participants|||Number
1449390|NCT00856193|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)|According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.|Day 14|Safety Population|||Participants|||Number
1449391|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 12 hours-24 hours after drug administration on Day 14|Efficacy analysis set|||Liters||Standard Error|Least Squares Mean
1449392|NCT00856193|Secondary|Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From day 1 to 0 -12 hours after drug administration on Day 14|Efficacy analysis set|||Liters||Standard Error|Least Squares Mean
1449393|NCT00856193|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14|Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.|From Day 1 to 0-24 hours after drug administration on Day 14|Efficacy analysis set|||Liters||Standard Error|Least Squares Mean
1449394|NCT00856180|Secondary|Overall Survival (OS)|OS estimated using Kaplan-Meier methods is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median follow-up was 23 months in this study cohort.|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
1449395|NCT00856180|Secondary|Progression-Free Survival (PFS)|PFS estimated using Kaplan-Meier methods is defined as the duration of time from the start of bevacizumab alone to documented disease progression (PD) requiring removal from the study or death. If participant ultimately received both bevacizumab and cyclophosphamide then it was the time until PD on both agents. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA-125 that rises to >/=2xULN documented, both requiring 2nd confirmation. Participants who were event-free were censored at the date of their last disease evaluation.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment and every 3 months in follow-up until PD, death or lost to follow-up. Median treatment duration was 7.5 months (range 0.7-20.7) and survival follow-up 23 months..|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
1449396|NCT00856180|Secondary|Clinical Benefit Response Rate|Clinical benefit response rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better on treatment based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.|||proportion of participants||90% Confidence Interval|Number
1449559|NCT00855413|Secondary|Minimum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and Weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
1449398|NCT00856180|Primary|Therapy Completion Rate|The therapy completion rate is defined as the proportion of participants who completed at least 3 months/4 cycles of therapy. Participants were treated until disease progression on the combination regimen or unacceptable toxicity. Clinical response was evaluated based on RECIST 1.0 criteria for measurable disease (MD) participants and Gynecologic Cancer Intergroup (GCIG) CA-125 (Rustin) criteria for non-MD participants. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Serologic PD is rise in CA-125 or previously normal CA125 that rises to >/=2xULN documented, both requiring 2nd confirmation.|Serologic and radiologic disease assessments occurred every 2 cycles/6 weeks on treatment. Median treatment duration for this study cohort was 7.5 months (range 0.7-20.7).|The analysis dataset is comprised of all treated participants.|||proportion of participants||80% Confidence Interval|Number
1449399|NCT00856050|Primary|Progression Free Survival Rate at 12 Weeks|Data below are reported as progression free rate (%).|12 weeks|27 patients were enrolled, and 26 patients received at least one dose of study medication and were included in the analysis.|||percentage of participants||90% Confidence Interval|Number
1449400|NCT00856024|Secondary|Percent of Participants Who Achieved Early Virologic Response (EVR)|EVR was defined as HCV RNA negative after 12 weeks of treatment.|Week 12|Number of participants with data|||Percent of participants||95% Confidence Interval|Number
1449401|NCT00856024|Secondary|Percent of Participants Who Achieved Rapid Virologic Response (RVR)|RVR was defined as HCV RNA negative after 4 weeks of treatment.|Week 4|Number of participants with data|||Percent of participants||95% Confidence Interval|Number
1449402|NCT00856024|Primary|Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks|The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.|First 12 weeks of treatment|All enrolled participants|||Percent of participants||95% Confidence Interval|Number
1449403|NCT00855959|Secondary|Number of Participants With Adverse Events (AEs)|Number of participants with AEs reported during the period on Pulmicort Respules|6 weeks||||Participants|||Number
1449404|NCT00855959|Secondary|Forced Vital Capacity (FVC)|Change in Forced Vital Capacity (FVC) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L||Standard Deviation|Mean
1449405|NCT00855959|Secondary|Forced Expiratory Volume in 1 Second (FEV 1.0)|Change in Forced Expiratory Volume in 1 second (FEV 1.0) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L||Standard Deviation|Mean
1449406|NCT00855959|Secondary|Night-time Awakenings Due to Asthma Symptoms|Change in Night-time awakenings due to asthma symptoms from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||awakenings||Standard Deviation|Mean
1449407|NCT00855959|Secondary|Use of Rescue Medication (Total)|Change in Use of rescue medication (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||puffs||Standard Deviation|Mean
1449408|NCT00855959|Secondary|Use of Rescue Medication (Night-time)|Change in Use of rescue medication (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||puffs||Standard Deviation|Mean
1449409|NCT00855959|Secondary|Use of Rescue Medication (Daytime)|Change in Use of rescue medication (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||puffs||Standard Deviation|Mean
1449410|NCT00855959|Secondary|Asthma Symptom Score (Total); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Total) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||Scores on a scale||Standard Deviation|Mean
1449411|NCT00855959|Secondary|Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Night-time) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||Scores on a scale||Standard Deviation|Mean
1449412|NCT00855959|Secondary|Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)|Change in Asthma symptom score (Daytime) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||Scores on a scale||Standard Deviation|Mean
1449413|NCT00855959|Secondary|Evening Peak Expiratory Flow (ePEF)|Change in evening peak expiratory flow (ePEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L/min||Standard Deviation|Mean
1449414|NCT00855959|Primary|Morning Peak Expiratory Flow (mPEF)|Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)|6 weeks||||L/min||Standard Deviation|Mean
1449415|NCT00855933|Primary|Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale|"A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).~For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit."|4 weeks||||units on a scale||Standard Error|Mean
1449416|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 24 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 24 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1449417|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 48 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 48 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1449418|NCT00855920|Secondary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint at 72 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain.|Baseline (Day 1) to 72 hours|Full analysis set (FAS) that included all randomized participants who received any study drug and had at least 1 post-baseline assessment. Here, number of participants analyzed=participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
1449419|NCT00855920|Primary|Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours|Participants were asked to complete a daily diary entry and assessed their pain in the past 24 hours using 5-point Likert Scale of 0 (None) to 4 (extreme pain), where; 0= none, 1= mild pain, 2= moderate pain, 3= severe pain, or 4= extreme pain. Change in PAP-LS in the index joint from baseline (Day 1) to the averaged PAP-LS values at 24, 48 and 72 hours was reported in this outcome measure (averaged PAP value= [PAP at 24 hours + PAP at 48 hours + PAP at 72 hours]/3).|Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends|Full analysis set (FAS) that included of all randomized participants who received any study drug and had at least 1 post-baseline assessment.|||units on a scale||Standard Deviation|Mean
1449420|NCT00855894|Secondary|Percentage of Patients With Disease Control (DC) at Day 56|DC was defined as a CR, a PR, or stable disease (SD) as determined by the investigator and based on CT using RECIST. A CR was defined as the disappearance of all target (TL) and non-target lesions (nTL). A PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline sum longest diameter, or the persistence of 1 or more nTLs and/or maintenance of a tumor marker level (TML) above normal limits. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (SSLD) since treatment started. For nTLs, SD was defined as the persistence of 1 or more lesions and/or maintenance of a TML above normal limits. PD was defined as ≥ 20% increase in the SLD of TLs, taking as reference the SSLD recorded since treatment started, the appearance of 1 or more new lesions, or the unequivocal progression of existing nTLs.|Baseline to Day 56|All 41 patients treated with erlotinib and pertuzumab.|||Percentage of patients||95% Confidence Interval|Number
1449421|NCT00855894|Secondary|Percentage of Patients With an Objective Response (OR)|OR was defined as a complete response (CR) or a partial response (PR) as determined by the investigator and based on computed tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) on 2 consecutive occasions at least 4 weeks apart. A complete response was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. A partial response was defined as ≥ 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or the persistence of 1 or more non-target lesions and/or the maintenance of a tumor marker level above the normal limits.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab.|||Percentage of patients||95% Confidence Interval|Number
1449422|NCT00855894|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of first dosing with pertuzumab and erlotinib until the date of patient death from any cause.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not died at the time of analysis for OS were censored at the date of last contact.|||Months||95% Confidence Interval|Median
1449423|NCT00855894|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dosing with pertuzumab and erlotinib to the first occurrence of disease progression (PD), as determined by the investigator and based on computed tomography using Response Evaluation Criteria in Solid Tumors (RECIST), or death from any cause, whichever comes first. PD was defined as ≥ 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started, the unequivocal progression of existing non-target lesions (non-TL), or the appearance of 1 or more new lesions. TLs were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, were identified as TLs. All other lesions (or sites of disease) were identified as non-TLs.|Baseline to the end of the study (up to 3 years)|All 41 patients treated with erlotinib and pertuzumab. Patients who had not progressed or died at the time of analysis for PFS were censored at the date of their last tumor assessment.|||Months||95% Confidence Interval|Median
1449435|NCT00855738|Secondary|Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)|HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
1449424|NCT00855894|Primary|Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups|The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.|Baseline to Day 56|All 41 patients treated with pertuzumab and erlotinib were evaluable for analysis. Patients with a missing Day 56 assessment were deemed non-responders. Tumor tissue samples were only available for 32 patients for EGFR mutation status analysis.|||Percentage of patients||95% Confidence Interval|Number
1449425|NCT00855868|Primary|Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.|Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.|28 d||||SUVR||Standard Deviation|Mean
1449426|NCT00855842|Primary|Length of Medical Abortion|This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus|hours since the start of medical abortion||||hours||Standard Deviation|Mean
1449427|NCT00855816|Primary|Change Scores for Criteria D Items on the CAPS Structured Clinical Interview|"Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment.~Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms.~Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms.~Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement)."|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1449428|NCT00855738|Secondary|Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit|Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU).|Month 6|FAS; LOCF.|||percent of participants|||Number
1449429|NCT00855738|Secondary|Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy|Numerical assessment of change in total number of days hospitalized because of epilepsy during the study.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.|||Days||Standard Deviation|Mean
1449430|NCT00855738|Secondary|Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy|Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study.|Baseline to Month 6|FAS; LOCF. Costs involved in health and non-health resources needed during the study were not analyzed as planned with this endpoint. N=number of subjects with visits to a specialist because of epilepsy.|||visits||Standard Deviation|Mean
1449431|NCT00855738|Secondary|Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)|MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night.|Baseline, Month 6|FAS; LOCF.|||percent of participants|||Number
1449432|NCT00855738|Secondary|Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)|Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night).|Baseline to Month 6|FAS LOCF. Change from baseline in Optimal sleep is not shown as changes from baseline were only evaluated for continuous parameters. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
1449433|NCT00855738|Secondary|Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)|Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Month 3, Month 6|FAS LOCF. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
1449434|NCT00855738|Secondary|Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)|QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life.|Baseline to Month 6|FAS; LOCF. N=number of subjects with evaluable data.|||scores on scale||Standard Deviation|Mean
1449436|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy||Baseline through Month 6 (or end of treatment)|FAS; LOCF. N= number of subjects with initial treatment administered as monotherapy.|||percent of participants|||Number
1449437|NCT00855738|Secondary|Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)||Baseline to Month 6 (or end of treatment)|FAS; LOCF.|||percent of participants||95% Confidence Interval|Number
1449439|NCT00855738|Secondary|Treatment Satisfaction Evaluated by Patient Global Impression of Change Visual Analog Scale (VAS)|Patient Global Impression of Change VAS: subject rated instrument to measure subject's change in overall status; range from 0 (much better) to 10 (much worse).|Baseline, Month 3, Month 6|FAS; LOCF. The scale for this endpoint was not collected and results were not analyzed as planned.|||scores on scale||Standard Deviation|Mean
1449440|NCT00855738|Secondary|Time to Discontinuation Due to Other Reasons||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to other reasons, the time to exit analyses was not performed.|||days||Full Range|Median
1449441|NCT00855738|Secondary|Time to Discontinuation Due to Safety, Tolerability, or Treatment Compliance||Baseline, Month 3, Month 6|FAS; LOCF. Due to the low number of participants who discontinued due to safety, tolerability or compliance with treatment, the time to exit analysis was not performed.|||days||Inter-Quartile Range|Median
1449442|NCT00855738|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline, Month 3, Month 6|FAS; LOCF. As no participants discontinued due to lack of efficacy, the time to exit analysis was not performed.|||days||Inter-Quartile Range|Median
1449443|NCT00855738|Secondary|Percent of Participants Who Continued on Study Medication to Month 6|Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study.|Baseline to Month 6|FAS; LOCF.|||percent of participants|||Number
1449444|NCT00855738|Secondary|Time to First Seizure|Number of days to first seizure after baseline.|Baseline to Month 6 (or end of treatment)|FAS LOCF. N=number of subjects with evaluable data.|||days||Standard Deviation|Mean
1449445|NCT00855738|Secondary|Percent of Days Without Crisis During the Study|Crisis was defined as the total number of seizures during the study, the seizures at month 3 plus the seizures at month 6. The percent of days without crisis is number of days of study (date of last visit minus date of baseline visit) without crisis divided by number of days of study, multiplied by 100.|Baseline through Month 6 (or end of treatment)|The percentage of days without crisis during the study was not evaluable because a diary with the daily number of crises was not collected.|||percentage of days|||Number
1449446|NCT00855738|Secondary|Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS LOCF. N=number of subjects with evaluable data.|||percent change||Inter-Quartile Range|Median
1449447|NCT00855738|Secondary|Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation||Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.|||percent of participants||95% Confidence Interval|Number
1449448|NCT00855738|Secondary|Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment|Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit.|Baseline, Month 3, Month 6 (last 3 months of treatment)|FAS; LOCF. N=number of subjects with evaluable data.|||percent of participants||95% Confidence Interval|Number
1449449|NCT00855738|Primary|Percent of Participants Classified as Responders|Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline).|Baseline, Month 3, Month 6 (last 3 months of treatment)|Full Analysis Set (FAS): intent-to-treat population = those who took at least 1 dose of study medication and had post-baseline data for at least 1 efficacy endpoint. Last Observation Carried Forward (LOCF) captures last 3 months of treatment for subjects who discontinued between Month 3 and Month 6 only. N=number of subjects with evaluable data.|||percent of participants||95% Confidence Interval|Number
1449450|NCT00855595|Other Pre-specified|Patient Opinion of Local Tolerability||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of Participants|||Number
1449451|NCT00855595|Secondary|Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of participants|||Number
1449452|NCT00855595|Secondary|Patient Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of participants|||Number
1449453|NCT00855595|Secondary|Investigator Rating of Overall Improvement at End of Study (Week 12)||Week 12|Participants in the FAS who took part in this evaluation.|||Percentage of participants|||Number
1449454|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 12|FAS|||Percentage of participants|||Number
1449455|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 8|FAS|||Percentage of participants|||Number
1449456|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 6|FAS|||Percentage of participants|||Number
1449457|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 4|FAS|||Percentage of participants|||Number
1449458|NCT00855595|Secondary|Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).|At Week 2|FAS|||Percentage of participants|||Number
1449560|NCT00855413|Secondary|Maximum Ritonavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and Weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
1449459|NCT00855595|Secondary|Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)|Weeks 2, 4, 6, 8 and 12|FAS|||Percentage of participants|||Number
1449460|NCT00855595|Secondary|Percentage of Participants With Investigator’s Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)|IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).|Weeks 2, 4, 6, 8 and 12|FAS|||Percentage of participants|||Number
1449461|NCT00855595|Secondary|Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)||Baseline and Weeks 2, 4, 6, 8 and 12|FAS|||Percentage of participants|||Number
1449462|NCT00855595|Secondary|Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2, 4, 6, 8 and 12|FAS|||Percent of inflammatory lesions||Standard Deviation|Mean
1449463|NCT00855595|Secondary|Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 4, 6, 8 and 12|FAS|||Inflammatory lesions||Standard Deviation|Mean
1449464|NCT00855595|Secondary|Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)||Week 2, 4, 6, 8 and 12|FAS|||Inflammatory lesions||Standard Deviation|Mean
1449465|NCT00855595|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)|NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)|Baseline and Week 2|Full analysis set (FAS)|||Inflammatory lesions||Standard Deviation|Mean
1449466|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint|Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||mL||Standard Deviation|Mean
1449467|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint|Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||mL/sec||Standard Deviation|Mean
1449468|NCT00855582|Secondary|Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint|Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||mL/sec||Standard Deviation|Mean
1449469|NCT00855582|Secondary|Erectile Function General Assessment Questionnaire (EF-GAQ)|The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response.|12 weeks|Participants started study medication, and had non-missing data.|||participants with yes response|||Number
1449470|NCT00855582|Secondary|Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint|A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.|||participants|||Number
1449471|NCT00855582|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint|A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).|12 weeks|Participants started study medication, and had non-missing data.|||participants|||Number
1449472|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
1449501|NCT00855465|Other Pre-specified|Mean QRS Duration (QRSmean) - Change From Baseline to Week 16|QRS duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
1449473|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
1449474|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
1449475|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint|IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449476|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint|IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449477|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint|Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
1449478|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint|Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
1449479|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint|Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449480|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12|The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449481|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449540|NCT00855439|Secondary|Cardiac Autonomic Neuropathy (CAN)|Group differences in E/I ratio, a measure of cardiac autonomic function.|18 months||||unit-less measure||Standard Deviation|Mean
1449561|NCT00855413|Secondary|Minimum Darunavir Exposure Range in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
1449482|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449483|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449484|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
1449485|NCT00855582|Secondary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449486|NCT00855582|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks, 8 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449487|NCT00855582|Secondary|Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint|The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 2 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449488|NCT00855582|Secondary|Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Least Squares Mean
1449489|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of yes responses||Standard Error|Least Squares Mean
1449490|NCT00855582|Secondary|Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg)|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on scale||Standard Error|Least Squares Mean
1449491|NCT00855582|Secondary|Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg)|"Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction."|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value.|||percentage of Yes responses||Standard Error|Least Squares Mean
1449492|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449493|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449494|NCT00855582|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg)|Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449495|NCT00855582|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg)|The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1449496|NCT00855465|Other Pre-specified|Mean Ventricular Rate (VRmean) - Change From Baseline to Week 16|Ventricular rate was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||beats per minute (bpm)||Standard Deviation|Mean
1449497|NCT00855465|Other Pre-specified|Mean RR Duration (RRmean) - Change From Baseline to Week 16|RR duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
1449498|NCT00855465|Other Pre-specified|Mean QTcF Duration (Fridericia's Correction Formula, QTcF) - Change From Baseline to Week 16|Fridericia-corrected QTcF duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
1449499|NCT00855465|Other Pre-specified|Mean QTcB Duration (Bazett's Correction Formula, QTcB) - Change From Baseline to Week 16|Bazett-corrected QTcB duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
1449500|NCT00855465|Other Pre-specified|Mean QT Duration (QTmean) - Change From Baseline to Week 16|QT duration was evaluated as part of the 12-lead electrocardiogram. ECGs were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
1449502|NCT00855465|Other Pre-specified|Mean PR Duration (PRmean) - Change From Baseline to Week 16|PR duration was evaluated as part of the 12-lead electrocardiogram. electrocardiograms (ECGs) were recorded after the participant had been at rest for 15 minutes in a supine position.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of ECG parameters.|||ms||Standard Deviation|Mean
1449503|NCT00855465|Other Pre-specified|Oxygen Saturation (SaO2) - Change From Baseline to Week 16|Oxygen saturation (SaO2) is measured as part of the capillary or arterial blood gas analysis. Normal blood oxygen saturation is considered 95-100 percent. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.|||Percentage of oxygen saturation||Standard Deviation|Mean
1449504|NCT00855465|Other Pre-specified|Arterial Partial Oxygen Pressure (PaO2) - Change From Baseline to Week 16|Arterial partial pressure of oxygen (PaO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.|||mmHg||Standard Deviation|Mean
1449505|NCT00855465|Other Pre-specified|Arterial Partial Pressure of Carbon Dioxide (PaCO2) - Change From Baseline to Week 16|Arterial partial pressure of carbon dioxide (PaCO2) is performed as part of the capillary or arterial blood gas analysis. If possible, no supplementary oxygen was given during the resting period and while blood samples were drawn.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of blood gas parameters.|||mmHg||Standard Deviation|Mean
1449506|NCT00855465|Other Pre-specified|Triacylglycerol Lipase - Change From Baseline to Week 16|Triacylglycerol lipase is a standard clinical chemistry parameter. Normal range: 7 to 60 U/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
1449507|NCT00855465|Other Pre-specified|Cystatin C - Change From Baseline to Week 16|Cystatin C is a biomarker. Normal range: 0.53 to 1.01 ng/mL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||ng/ml||Standard Deviation|Mean
1449508|NCT00855465|Other Pre-specified|Urea (BUN) - Change From Baseline to Week 16|Urea (blood urea nitrogen, BUN) is a standard clinical chemistry parameter. Normal range: 4 to 25 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
1449509|NCT00855465|Other Pre-specified|Urate - Change From Baseline to Week 16|Urate is a standard clinical chemistry parameter. Normal range: 4.0 to 8.5 mg/dL (males, 16-59 years), 3.4 to 8.7 mg/dL (males, >60 years) 2.5 to 7.5 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
1449510|NCT00855465|Other Pre-specified|Potassium - Change From Baseline to Week 16|Potassium is a standard clinical chemistry parameter. Normal range: 3.5 to 5.3 mmol/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mmol/L||Standard Deviation|Mean
1449511|NCT00855465|Other Pre-specified|Hematocrit - Change From Baseline to Week 16|Hematocrit is a standard clinical hematology parameter. Normal range: 40 to 52% (males), 36 to 46% (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||Volume percentage of red blood cells||Standard Deviation|Mean
1449512|NCT00855465|Other Pre-specified|Hemoglobin - Change From Baseline to Week 16|Hemoglobin is a standard clinical hematology parameter. Normal range: 13.5 to 17.5 g/dL (males), 12.0 to 16.0 g/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||g/dL||Standard Deviation|Mean
1449513|NCT00855465|Other Pre-specified|Neutrophils - Change From Baseline to Week 16|Neutrophils is a standard clinical hematology parameter. Normal range: 1.6 to 7.4*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^9 cells/L||Standard Deviation|Mean
1449556|NCT00855413|Secondary|Maximum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
1449514|NCT00855465|Other Pre-specified|Lymphocytes - Change From Baseline to Week 16|Total lymphocytes is a standard clinical hematology parameter. Normal range: 1.0 to 4.0*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^9 cells/L||Standard Deviation|Mean
1449515|NCT00855465|Other Pre-specified|Leukocytes (WBC) - Change From Baseline to Week 16|Leukocytes (white blood cells, WBC) is a standard clinical hematology parameter. Normal range: 4.0 to 10.7*10^9 cells/L|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^9 cells/L||Standard Deviation|Mean
1449516|NCT00855465|Other Pre-specified|Erythrocytes (RBC) - Change From Baseline to Week 16|Erythrocytes (red blood cells, RBC) is a standard clinical hematology parameter. Normal range: 4.6 to 5.8*10^12 cells/L (males), 4.1 to 5.2*10^12 cells/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||*10^12 cells/L||Standard Deviation|Mean
1449517|NCT00855465|Other Pre-specified|Creatine Kinase (CK) - Change From Baseline to Week 16|Creatine Kinase is a standard clinical chemistry parameter. Normal range: 35 to 232 U/L (males), 26 to 145 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
1449518|NCT00855465|Other Pre-specified|Creatinine Clearance - Change From Baseline to Week 16|Creatinine clearance is a standard clinical chemistry parameter. Normal range: 90 to 140 mL/min (males), 80 to 125 mL/min (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mL/min||Standard Deviation|Mean
1449519|NCT00855465|Other Pre-specified|Creatinine - Change From Baseline to Week 16|Creatinine is a standard clinical chemistry parameter. Normal range: 0.25 to 1.20 mg/dL (males), 0.46 to 1.00 mg/dL (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
1449520|NCT00855465|Other Pre-specified|Bilirubin - Change From Baseline to Week 16|Bilirubin is a standard clinical chemistry parameter. Normal range: 0.1 to 1.2 mg/dL|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||mg/dL||Standard Deviation|Mean
1449521|NCT00855465|Other Pre-specified|Alkaline Phosphatase (AP) - Change From Baseline to Week 16|Alkaline phosphatase (AP) is a standard clinical chemistry parameter. Normal range: 40 to 129 U/L (males), 35 to 104 U/L (females)|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
1449522|NCT00855465|Other Pre-specified|Aspartate Aminotransferase (AST) - Change From Baseline to Week 16|Aspartate Aminotransferase (AST) is a standard clinical chemistry parameter. Normal range: 0 to 41 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
1449523|NCT00855465|Other Pre-specified|Alanine Aminotransferase (ALT) - Change From Baseline to Week 16|Alanine Aminotransferase (ALT) is a standard clinical chemistry parameter. Normal range: 0 to 45 U/L.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one measurement on treatment (or up to two days after stopping treatment) were included in the analysis of laboratory parameters.|||U/L||Standard Deviation|Mean
1449524|NCT00855465|Other Pre-specified|Heart Rate (HR) - Change From Baseline to Week 16|Heart rate (HR) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 50 -105 beats per minute (bpm) at rest.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.|||Beats/min||Standard Deviation|Mean
1449525|NCT00855465|Other Pre-specified|Diastolic Blood Pressure (DBP) - Change From Baseline to Week 16|Diastolic systemic arterial blood pressure (DBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: <= 110 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.|||mmHg||Standard Deviation|Mean
1449526|NCT00855465|Other Pre-specified|Systolic Blood Pressure (SBP) - Change From Baseline to Week 16|Systolic systemic arterial blood pressure (SBP) is a directly non-invasively measured hemodynamic parameter. Range allowed in this study at Visit 0 and/or Visit 1 before randomization: 95 – 180 mmHg.|Baseline and week 16|Safety (SAF) - a randomized participant was valid for safety analyses if at least one dose of study medication was administered.|||mmHg||Standard Deviation|Mean
1449557|NCT00855413|Secondary|Minimum Etravirine Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between Week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
1449527|NCT00855465|Other Pre-specified|Cardiac Index (CI) - Change From Baseline to Week 16|The cardiac index (CI) is a calculated hemodynamic parameter. CI is derived from the directly measured parameters cardiac output (CO), divided by the body surface area (BSA). BSA is a calculated parameter, using the subject’s height and weight in the DuBois formula. Formula: BSA = (W [kg]*0.425)*(H [cm]*0.725)*0.007184 (m^2)|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.~Only participants with a baseline and at least one post-baseline measurement were included in the analysis of CI."|||L/min/m^2||Standard Deviation|Mean
1449528|NCT00855465|Other Pre-specified|Mean Pulmonary Artery Pressure (PAPmean) - Change From Baseline to Week 16|Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.|Baseline and week 16|"Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.~Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PAPmean."|||mmHg||Standard Deviation|Mean
1449529|NCT00855465|Other Pre-specified|All Caused Mortality|"All cause mortality (including cardiovascular mortality) was one component of the composite endpoint time to clinical worsening."|At visit 6 (week 16)|Intent to Treat (ITT) - a randomized subject was valid for ITT analyses if at least one dose of study medication was administered.|||Participants|||Number
1449530|NCT00855465|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.|||Scores on a scale||Standard Deviation|Mean
1449531|NCT00855465|Secondary|EQ-5D Utility Score - Change From Baseline to Week 16|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.|||Scores on a scale||Standard Deviation|Mean
1449532|NCT00855465|Secondary|Borg CR 10 Scale - Change From Baseline to Week 16|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Scores on a scale||Standard Deviation|Mean
1449533|NCT00855465|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; rescue endarterectomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH.|At week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Percentage of participants|||Number
1449534|NCT00855465|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 16|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.|||Percentage of Participants|||Number
1449535|NCT00855465|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.|||pg/mL||Standard Deviation|Mean
1449536|NCT00855465|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.|||dyn*s*cm^-5||Standard Deviation|Mean
1449537|NCT00855465|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16|6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.|Baseline and week 16|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Meters||Standard Deviation|Mean
1449538|NCT00855439|Other Pre-specified|Intra-epidermal Nerve Fiber Density|Exploratory endpoint: Regeneration of intra-epidermal nerve fibers after denervation by capsiacin.|12 months|Subset of study population|||nerve fibers per mm of skin||Standard Deviation|Mean
1449539|NCT00855439|Secondary|Cardiac Autonomic Neuropathy|resting heart rate as marker of autonomic function at rest|18 month||||beats per minute||Standard Deviation|Mean
1449541|NCT00855439|Primary|Confirmed Clinical Neuropathy (CCN)|CCN was defined by a composite score comprised of at least two positive responses among symptoms, sensory signs, or absent or hypoactive reflexes consistent with a distal symmetrical polyneuropathy (16), and at least one abnormal nerve conduction study result in two anatomically distinct nerves, e.g. the sural sensory and peroneal motor nerves (defined as a amplitude < 5 μV and a conduction velocity < 40 m/sec for the sural nerve and an amplitude < 2.5 μV and a conduction velocity < 40 m/sec for the peroneal nerve).|18 Months||||participants|||Number
1449542|NCT00855413|Secondary|HIV RNA Detection in Ileal Biopsy Specimens|Average HIV RNA detected in the ileal biopsy specimens per participant over weeks 4 and 48.|Weeks 4 and 48|Study stopped prior to target enrollment by sponsor. Given insufficient ileal biopsy samples, correlation of HIV viremia in ileal biopsies with time to suppression was not performed due to inadequate power to analyze the outcome.|||copies/mL||Full Range|Mean
1449543|NCT00855413|Secondary|Correlation of Time to HIV RNA Levels <200 Copies/mL With Improvement in Neurocognitive Functioning From Baseline to Week 24 and 48||Baseline to Week 24 and 48|Participants who consented to optional neurocognitive assessments at baseline and week 24 or 48|||r value|||Number
1449544|NCT00855413|Secondary|Correlation of HIV RNA Levels in CSF and Drug Levels With Neurocognitive Functioning||From enrollment through Week 48|Participants who consented to neurocognitive assessments at baseline and week 24 or 48. Sponsor stopped study prior to target enrollment.|||r value|||Number
1449545|NCT00855413|Secondary|Change in Overall Neurocognitive Impairment From Baseline to Week 24 or 48|Change in overall z score from baseline to week 24 or 48. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Baseline to Week 24 or 48|Participants who underwent neurocognitive assessment at baseline and Week 24 and/or 48.|||z score||Standard Deviation|Mean
1449546|NCT00855413|Secondary|Overall Neurocognitive Impairment at Week 48|Neuropsychological performance was assessed at baseline (week 2 or 4), week 24 and week 48 in the following domain (measures): Premorbid/language (Wide Range Achievement Test (WRAT) 4 - Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test – Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 48|participants who underwent neurocognitive assessment at baseline and week 48|||z score||Standard Deviation|Mean
1449547|NCT00855413|Secondary|Overall Neurocognitive Impairment at Week 24|Neuropsychological performance was assessed at week 2 or 4, week 24 and week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (Hopkins Verbal Learning Test – Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score of neurocognitive functioning was created by averaging all tests. Participants also completed Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 24|participants who underwent neurocognitive assessment at baseline and week 24|||z score||Standard Deviation|Mean
1449548|NCT00855413|Secondary|Overall Neurocognitive Impairment Score at Week 2 or 4|Neuropsychological performance was assessed at Week 2 or 4, Week 24 and Week 48 in the following measures: Premorbid/language (Wide Range Achievement Test 4 -Reading Subtest), Learning (HVLT-R, Hopkins Verbal Learning Test–Revised), Memory (HVLT-R), Speed of Processing (Trailmaking A (Army Individual Test Battery, 1944), 1974, Stroop color, Attention (WAIS-III Symbol Search; Stroop word, Fine motor, Executive (Trailmaking B, Stroop interference, Letter, Category Fluency. An overall summary score was created by averaging all tests. Participants also completed the self-reported functional status Patient's Assessment of Own Functioning Inventory (PAOFI) and the Activities of Daily Living Scale (ADLS). Best available demographically corrected normative data were utilized to create z scores. A negative z score denotes below-average performance relative to a US normative comparison population. A higher z score is a better outcome.|Week 2 or 4|participants who underwent neurocognitive assessment at week 2 or 4|||z score||Standard Deviation|Mean
1449549|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Week 48||Week 48|Participants who consented to optional procedure of neurocognitive assessment at week 48|||Participants|||Count of Participants
1449550|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Week 24||Week 24|Participants who consented to optional procedure of neurocognitive assessment at week 24|||Participants|||Count of Participants
1449551|NCT00855413|Secondary|Number of Participants With Neurocognitive Impairment at Baseline||Week 2 or 4|Participants who consented to optional procedure of neurocognitive assessment at baseline|||Participants|||Count of Participants
1449552|NCT00855413|Secondary|Number of Participants With HIV RNA Measurement Above the Limits of Detection in Cerebrospinal Fluid||Week 4 and Week 48|Four participants provided 7 CSF samples for measurement of HIV RNA level|||participants|||Number
1449553|NCT00855413|Secondary|Minimum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
1449554|NCT00855413|Secondary|Maximum Ritonavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between Weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
1449555|NCT00855413|Secondary|Minimum Darunavir Exposure Range in Ileal Tissue Among Participants Who Consented to an Optional Gut Biopsy Procedure||between week 4-12 and between weeks 36-48|Six participants consented to ileal biopsy for measurement of drug levels|||ng/g|||Number
1449562|NCT00855413|Secondary|Maximum Darunavir Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
1449563|NCT00855413|Secondary|Minimum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
1449564|NCT00855413|Secondary|Maximum Etravirine Exposure in Semen Among Participants Who Consented to an Optional Collection of Semen||Weeks 0-4 and weeks 12, 48|Four participants consented to provide a semen sample for measurement of drug levels.|||ng/mL|||Number
1449565|NCT00855413|Secondary|Minimum Ritonavir Exposure Range in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
1449566|NCT00855413|Secondary|Maximum Ritonavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and Week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
1449567|NCT00855413|Secondary|Minimum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
1449568|NCT00855413|Secondary|Maximum Darunavir Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|Four participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
1449569|NCT00855413|Secondary|Minimum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|4 participants consented to 7 optional lumbar puncture to provide CSF sample for measurement of drug levels.|||ng/mL|||Number
1449570|NCT00855413|Secondary|Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture||Week 4 and week 48|4 participants consented to 7 optional lumbar punctures to provide CSF samples for measurement of drug levels.|||ng/mL|||Number
1449571|NCT00855413|Secondary|Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48|Total number of adverse events observed that were possibly or definitely related to study treatment through week 48|Enrollment to week 48||||adverse events|||Number
1449572|NCT00855413|Secondary|Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance||Enrollment to Week 48||||Participants|||Count of Participants
1449573|NCT00855413|Secondary|HIV RNA Detection in Semen|Total cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48.|From enrollment through 48 weeks|Study stopped prior to target enrollment by sponsor. Given insufficient semen samples, correlation of HIV viremia in semen with time to suppression was not performed due to inadequate power to analyze the outcome.|||copies/mL||Full Range|Mean
1449574|NCT00855413|Secondary|Median Time to HIV RNA Suppression to <200 Copies/mL||From enrollment to the date of HIV RNA suppression, assessed up to Week 48||||days||Full Range|Median
1449575|NCT00855413|Secondary|HIV RNA Levels Immediately Prior to Initiating Study Treatment.||HIV RNA level at enrollment||||copies/mL||Full Range|Median
1449576|NCT00855413|Secondary|Median Change in CD4 Cell Count From Week 0 to Week 48.||48 weeks from enrollment|12 participants with a week 48 study visit were included in analysis|||cells/mm^3||Full Range|Median
1449577|NCT00855413|Secondary|Median Change in CD4 Cell Count From Week 0 to Week 24.||week 0, week 24|All participants enrolled were included in this analysis|||cells/mm^3||Full Range|Median
1449578|NCT00855413|Secondary|Number of Participants With Virologic Response|Virologic response to study treatment defined as plasma HIV RNA measurement <50 copies/mL at week 48|48 weeks from enrollment|All participants retained on study through week 48 were included in the analysis of virologic efficacy at week 48|||Participants|||Count of Participants
1449579|NCT00855413|Primary|Number of Participants With Virologic Response|Virologic response defined as plasma HIV RNA measurement <200 copies/mL at week 24|24 weeks|All participants enrolled were included in analysis of virologic response|||Participants|||Count of Participants
1449580|NCT00855335|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to follow up period (16 weeks after postpartum)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.|||Participants|||Number
1449581|NCT00855335|Secondary|Number of Infants With Human Immunodeficiency Virus (HIV) Positive Test Result|The infants were evaluated for HIV positive tests using HIV polymerase chain reaction test (PCR).|Birth to age 16 weeks|Infants population whose mothers were included in Intent-to-treat (ITT) analysis set and who were enrolled in this study and took at least one dose of study medication. 'N' signifies number of infants who were born and had HIV test data available.|||infants|||Number
1449582|NCT00855335|Secondary|Plasma Concentration of Drug in the Cord Plasma and Maternal Plasma Samples Collected at the Time of Delivery|The drug concentrations were evaluated in the cord plasma and maternal plasma samples collected at the time of delivery.|On day of delivery - Intrapartum (Visit 6)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1449651|NCT00854581|Primary|The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission|Number of participants achieving a molecular remission after starting valproic acid as evidenced by disappearance of T-cell clonality as measured by gene rearrangement studies using multiplex PCR|3, 6 and 12 months.|Participants achieving CR or PR in Part 1 Maintenance and moving on to Part 2B Maintenance therapy|||participants|||Number
1449583|NCT00855335|Secondary|Number of Participants With Resistance at Virological Failure|Resistance analysis was determined using genotypic and phenotypic analysis at the time of virological failure. For participants with a baseline viral load greater than (>) 200 copies/mL, virologic failure was defined as follows: HIV ribonucleic acid (RNA) levels that did not fall by at least 0.5 log 4 weeks after Baseline; viral load >1000 copies/mL (at 2 successive visits) by gestational weeks 34-38; or viral load >200 copies/mL (at 2 successive visits) after reaching a viral load less than or equal to (<=) 200 copies/mL. For participants with a baseline viral load <=200 copies/mL, virologic failure was defined as viral load of >200 copies/mL (at 2 successive visits) at any point during the study.|Up to follow-up phase (16 weeks after postpartum)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication.|||Participants|||Number
1449584|NCT00855335|Secondary|Mean Change From Baseline in CD4+ Cell Count|Mean Change From Baseline in CD4+ Cell Count were assessed for immunology testing.|Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here 'N' signified number of participants evaluated for this outcome measure.|||10^6 Cells/Liter||Standard Error|Mean
1449585|NCT00855335|Secondary|Mean Change From Baseline in Log10 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Viral Load Value|Mean change from baseline in log 10 HIV-1 RNA VL was assessed up to postpartum (6-12 weeks).|Baseline, 4 weeks after baseline, 2nd and 3rd trimesters of pregnancy and postpartum (2-5 weeks and 6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||Log 10 copies per milliliter (copies/mL)||Standard Error|Mean
1449586|NCT00855335|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Plasma Viral Load (<) 50 Copies/Milliliter (mL)|Number of participants were assessed with a viral load (VL) lesser than (<) 50 HIV-1 RNA copies/ mL over time.|Up to postpartum (6-12 weeks)|Intent-to-treat (ITT) analysis set is defined as all participants enrolled in this study who took at least one dose of study medication. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||Participants|||Number
1449587|NCT00855335|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h)|The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose. The selected arms were based on the dosing frequency (once daily).|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1449588|NCT00855335|Primary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours Post-dose (AUC0-12h)|The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours post dose. The selected arms were based on the dosing frequency (twice daily).|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
1449589|NCT00855335|Primary|Time to Reach the Maximum Plasma Concentration (Tmax)|The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||hour (h)||Full Range|Median
1449590|NCT00855335|Primary|Maximum Plasma Concentration (Cmax)|The Cmax is the maximum observed plasma concentration.|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1449591|NCT00855335|Primary|Minimum Plasma Concentration (Cmin)|The Cmin is the minimum observed plasma concentration.|Between Predose and 24 hours postdose at Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1449592|NCT00855335|Primary|Predose (Trough) Plasma Concentration (C0h)|C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.|Predose on Weeks 24-28 (Visit 4, 2nd trimester), 34-38 (visit 5, 3rd trimester) and 6-12 weeks postpartum (visit 8)|Population analyzed included participants who received at least one dose of study drug with at least one PK blood sample available. Arms were created to report data separately for the treatments and analytes. Here ‘N’ signifies number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1449593|NCT00855309|Primary|Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline||24 hours||||participants|||Number
1449674|NCT00854113|Primary|t1/2|Pharmacokinetics results.t 1/2 - apparent terminal half life|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||hour||Standard Deviation|Mean
1449675|NCT00854113|Primary|AUC 0-t|Pharmacokinetics results. AUC 0-t - Are under plasma concentration-time curve from time 0 time t.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||ng*hr/ml||Standard Deviation|Mean
1449594|NCT00855218|Secondary|Tumor Response – Investigator Assessment|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Participants|||Number
1449595|NCT00855218|Secondary|Tumor Response - Independent Radiological Review|Tumor Response was defined as the number of participants with a confirmed Complete Response (CR)=disappearance of all clinical and radiological tumor lesions, Partial Response (PR)= at least 30% decrease in sum of the longest diameters (LD) of tumor lesions, Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease, or Progressive Disease (PD)=at least 20% increase in the sum of LD of measured lesions, observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Participants|||Number
1449596|NCT00855218|Secondary|Time to Vascular Invasion/Extrahepatic Spread (TTVI/ES)|Time to vascular invasion/extrahepatic spread (TTVI/ES) was defined as the time (days) from randomization to vascular invasion/extrahepatic spread. Participants without vascular invasion/extrahepatic spread at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
1449597|NCT00855218|Secondary|Time to Untreatable Progression (TTUP)|Time to untreatable progression (TTUP) was defined as the time (days) from randomization to untreatable progression. Participants without untreatable progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
1449598|NCT00855218|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time (days) from randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last date of last contact.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
1449599|NCT00855218|Primary|Time to Progression (TTP) – Independent Radiological Review (Primary Analysis)|TTP is defined as the time (days) from randomization to radiological confirmed disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation.|From randomization of the first participant until 28 months later (cut-off date)|Intent-to-treat (ITT)|||Days||95% Confidence Interval|Median
1449600|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)|||Percent||95% Confidence Interval|Least Squares Mean
1449601|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)|||Percent||95% Confidence Interval|Least Squares Mean
1449602|NCT00855166|Other Pre-specified|Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.|Baseline to Week 102|Safety Analysis Set (all participants who received at least one dose of double-blind study medication)|||Percent||95% Confidence Interval|Least Squares Mean
1449603|NCT00855166|Secondary|Proportion of Participants With Body Weight Decrease ≥5%|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1449604|NCT00855166|Secondary|Adjusted Mean Change in Body Fat Mass|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1449605|NCT00855166|Secondary|Adjusted Mean Change in Waist Circumference|To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||cm||95% Confidence Interval|Least Squares Mean
1449606|NCT00855166|Primary|Adjusted Mean Change in Total Body Weight|To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.|Baseline to Week 24|Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
1449676|NCT00854113|Primary|Tmax|Pharmacokinetics results. Time to maximum plasma drug concentration (Tmax) was calculated for each groups|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||hour||Full Range|Median
1449677|NCT00854113|Primary|Cmax|Pharmacokinetics results. Cmax -Maximum plasma drug concentration|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||ng/ml||Standard Deviation|Mean
1449607|NCT00855062|Secondary|24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score|"The outcome is the total CES-D score at week 24 - the total CES-D score at baseline.~The total CES-D score is based on 20 CES-D items, such as I was bothered by things that usually don't bother me and I did not feel like eating, my appetite was poor. Patients were asked to answer each item by 4 scales: (1) Rarely, (2) Sometimes, (3) Occasionally, and (4) Most of the time. After 4 negative items were multiplied by -1, the total CES-D score is a simple sum of all items.~The min and Max are 0 and 60, respectively. Higher scores indicate more severe depressive symptoms."|At baseline and week 24|The analysis includes participants with CES-D scores at baseline and week 24.|||scores on a scale||Standard Deviation|Mean
1449608|NCT00855062|Secondary|24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed)|The outcome is the HIV RNA plasma viral loads (Log10 transformed) at week 24 - the viral loads (Log10 transformed) at baseline.|At baseline and week 24|The analysis includes participants with HIV RNA viral loads at baseline and week 24.|||copies/mL||Inter-Quartile Range|Median
1449609|NCT00855062|Secondary|24-week Change of Instrumental Activities of Daily Living|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The analysis includes participants with IADL scores at baseline and week 24.|||percentage of participants|||Number
1449610|NCT00855062|Secondary|48-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 48 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 48|This analysis used the participants with CD4 cell counts at baseline and week 48.|||cells/mm^3||Standard Deviation|Mean
1449611|NCT00855062|Secondary|24-week Change of CD4 Cell Counts|The outcome is defined as CD4 cell count at week 24 - CD4 cell count at baseline. The unit is cells/mm^3.|At baseline and week 24|This analysis used the participants with CD4 cell counts at baseline and week 24.|||cells/mm^3||Standard Deviation|Mean
1449612|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms|The outcome is the time of first Grade ≥ 2 toxicity and/or sign and symptoms from treatment initiation up to 48 weeks. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks|This analysis includes every randomized participants. A total of 22 minocycline and 21 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 48 weeks.|||participants with an event|||Number
1449613|NCT00855062|Secondary|Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms.|The outcome is the time to first Grade ≥ 2 toxicity and/or sign and symptoms from study treatment initiation up to week 24. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.|Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24|This analysis includes every randomized participants. A total of 21 minocycline and 20 placebo participants reported at least one Grade ≥ 2 toxicity and/or sign and symptoms during 24 weeks|||participants with an event|||Number
1449614|NCT00855062|Secondary|24-week Change of Karnofsky Performance Score|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|This analysis includes the participants with Karnofsky performance score at baseline and week 24.|||percentage of participants|||Number
1449615|NCT00855062|Secondary|24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage|The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.|At baseline and week 24|The descriptive statistics were based on observed data. Since all participants reported there were no change in the MSK score at week 24, no statistical test was conducted.|||participants|||Number
1449616|NCT00855062|Primary|24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)|"The U NP Sum is defined as the average of z scores for 9 neuropsychological test subcomponents in the neuropsychological test battery (i.e. the average of norm-adjusted (z) scores for Grooved Pegboard Dominant Hand, Grooved Pegboard Non-dominant Hand, Color Trails 1, Color Trails 2, Symbol Digit, WHO-UCLA Verbal Learning test Trial 5, WHO-UCLA Verbal Learning test delayed recall, Digit Span forward and Digit Span backward). The outcome is defined as U NP Sum at week 24 - U NP Sum at baseline."|At baseline and week 24|The descriptive statistics are based on per protocol analysis. For the statistical analysis, ITT analysis was used and the missing U NP Sums at week 24 were imputed using a multiple regression imputation method. The number of participants analyzed for the ITT analysis was 73 (36 for Minocycline and 37 for Placebo).|||z-score||Standard Deviation|Mean
1449617|NCT00855010|Secondary|Disposition Index|Disposition index is a measure of insulin secretion multiplied by insulin sensitivity, both derived from intravenous glucose tolerance test. A higher number means the pancreas is better able to lower blood glucose and a lower number means the pancreas is less able to lower blood glucose|12 months||||Unitless||Inter-Quartile Range|Median
1449618|NCT00855010|Secondary|Bone Mineral Density|Areal Bone Mineral Density at the L2-L4 antero-posterior lumbar spine, left femoral neck and total hip were measured by DXA scan using a Hologic Discovery Instrument scanner.|12 months||||g/cm^2||Standard Deviation|Mean
1449619|NCT00855010|Secondary|Visceral Fat Area|Abdominal MRI was performed to quantify visceral fat area at the L2-L3 level.|12 months||||cm^2||Standard Deviation|Mean
1449620|NCT00855010|Secondary|Subcutaneous Fat Area|Abdominal MRI was performed to quantify subcutaneous fat area at the L2-L3 level.|12 months||||cm^2||Standard Deviation|Mean
1449621|NCT00855010|Secondary|Hepatic Fat Content|Hepatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.|12 months||||percentage||Inter-Quartile Range|Median
1449622|NCT00855010|Secondary|Beta-cell Function|Changes in B-cell function as measured by acute insulin release to glucose (AIRg)|12 months||||microUnits/mL x min||Inter-Quartile Range|Median
1449623|NCT00855010|Primary|Bone Turnover Marker - Plasma 25-hydroxyvitamin D|Plasma 25-hydroxyvitamin D was determined by radioimmunoassay|12 months||||ng/mL||Inter-Quartile Range|Median
1449624|NCT00855010|Primary|Bone Turnover Marker - Intact Parathyroid Hormone (PTH)|Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .|12 months||||pg/mL||Inter-Quartile Range|Median
1449625|NCT00855010|Primary|Pancreatic Fat Content|Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.|12 months||||Percentage of fat||Inter-Quartile Range|Median
1449626|NCT00854906|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire|The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used in dry eye studies. The OSDI Scale ranges from 0= Normal to 100= Severe. Subcategories include problems--all of the time, most of the time, half of the time,and none of the time.|1 week|By comparing the KTBUT and the FTBUT to the Ocular Surface Disease Index (OSDI) questionnaire score of each participant, we will be able to evaluate the difference in tear break up time using these items. The OSDI was given once before the participant's KTBUT and FTBUT was measured.|||participants||Standard Deviation|Mean
1449627|NCT00854906|Primary|Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)|This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.|1 day|The number of participants for analysis was determined if each participant met all of the study protocol's inclusion and exclusion criteria. KTBUT and FTBUT were measured on all study participants.|||time in seconds|Participants|Standard Deviation|Mean
1449628|NCT00854724|Primary|Amount of Alcohol Consumed||During a 90 minute drinking session||||Number of drinks consumed||Standard Error|Mean
1449629|NCT00854620|Primary|Time-to-progression (TTP)||12 months||||months||Full Range|Median
1449630|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
1449631|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1449632|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
1449633|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 through 6|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1449634|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
1449635|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1450870|NCT00845663|Secondary|Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles|Categorized answer ranges from not at all to extremely.|Before and 24 hours post-dose|Intent-to-treat population|||Participants|||Number
1449636|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
1449637|NCT00854607|Secondary|Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD. The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Week 1|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1449638|NCT00854607|Secondary|Average of the Z-scores of %CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
1449639|NCT00854607|Secondary|Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
1449640|NCT00854607|Secondary|Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 12.|||Average Z-Score||Standard Deviation|Mean
1449641|NCT00854607|Secondary|Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD. The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1449642|NCT00854607|Secondary|Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD. The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1449694|NCT00853957|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1449643|NCT00854607|Secondary|Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD. The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and had a clinical outcome determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1449644|NCT00854607|Primary|Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-β-D-glucan (βDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6.|After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG. Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment. For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall standard deviation (SD). The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.|Weeks 1 and 2|Surviving participants with proven or probable IA at Day 14 post antifungal therapy, who had at least two valid results for each biomarker, and whose clinical outcome was determined at Week 6.|||Average Z-Score||Standard Deviation|Mean
1449645|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the attitude scale of the survey.|||units on a scale||Standard Deviation|Mean
1449646|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:~Instruct patients on home glucose monitoring~Teach foot care~Teach insulin administration~Instruct patients about diet~Help patients make changes in their diets that you have recommended~Instruct patients about regular exercise~Help patients make changes in their exercise habits that you have recommended~Identify candidates for long-acting insulin~Interpret glucose patterns~Adjust insulin in insulin-treated patients with poor glycemic control~Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin~Manage patients with poor glycemic control~Initiate insulin therapy (NPH or insulin glargine and aspart)~Apply principles of diabetes care in a team setting~Averages of provider efficacy were calculated across all activities."|22 months (post-intervention)|Providers within sites randomized to control and intervention arms were surveyed after the intervention period; 20 control arm providers and 29 intervention arm providers completed the ability items of the survey.|||units on a scale||Standard Deviation|Mean
1449647|NCT00854594|Primary|Provider Abilities Scale - Subscale From the Midwest (MW) Clinicians' Network|"Providers asked to indicate their level of confidence on an 11-point scale, with 0 indicating 'not at all confident' and 10 indicating 'extremely confident' for the following activities:~Instruct patients on home glucose monitoring~Teach foot care~Teach insulin administration~Instruct patients about diet~Help patients make changes in their diets that you have recommended~Instruct patients about regular exercise~Help patients make changes in their exercise habits that you have recommended~Identify candidates for long-acting insulin~Interpret glucose patterns~Adjust insulin in insulin-treated patients with poor glycemic control~Do you feel comfortable knowing whether to titrate basal insulin versus bolus insulin~Manage patients with poor glycemic control~Initiate insulin therapy (NPH or insulin glargine and aspart)~Apply principles of diabetes care in a team setting~Averages of provider efficacy were calculated across all activities."|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 55 intervention arm providers completed the ability items of the survey.|||units on a scale||Standard Deviation|Mean
1449648|NCT00854594|Secondary|Attitudes Toward Healthcare Teams Scale and Subscales|A validated scale developed to assess attitudes towards teams in a healthcare setting with three subscales to assess attitudes toward team value, attitudes toward team efficiency, and attitudes towards physician's shared role on a team. Each of the 21 items is rated 1 to 6, ranging from 'Strongly Disagree' to 'Strongly Agree'. The scale was considered 'complete' for analysis among providers who answered at least 7 of the 21 items. Items were reverse-coded as specified in the subscale development publication. Averages across completed items were calculated within provider. Higher values corresponded with more positive attitudes towards teams.|Baseline|Providers within sites randomized to control and intervention arms were surveyed at baseline; 39 control arm providers and 53 intervention arm providers complete the attitude scale of the survey.|||units on a scale||Standard Deviation|Mean
1449649|NCT00854581|Secondary|Overall Survival|Overall survival (OS) is the elapsed time from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up was censored at date of last contact.|From date of treatment initiation until date of death, assessed up to 5 years||||months||95% Confidence Interval|Median
1449650|NCT00854581|Secondary|Failure-free Survival (FFS)|Failure-free survival is the elapsed time from the date of initiation of study treatment until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time was censored at the last documented date of failure-free status.|From date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
1449652|NCT00854581|Primary|Number of Participants Exhibiting NF-kB Inhibition Upon Treatment With AZT in Vivo|Number of patients exhibiting NF-kb inhibition upon treatment with AZT in vivo. Investigation of whether AZT functions as an inhibitor of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) in vivo by analyzing serially collected leukemic samples during the first 48 hours of treatment with AZT only. The investigators will report the number of participants exhibiting NF-kB inhibition upon treatment with AZT in vivo and correlate with response using two-sample t-test.|During 48 hours of first AZT therapy|Participants receiving Zidovudine (AZT) therapy who achieved complete response (CR) or partial response (PR).|||participants|||Number
1449653|NCT00854581|Primary|Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants|Expressions of c-Rel, IRF-4 or other molecular events (p53, p16 mutations) including expansion of novel clones obtained at time of relapse will be compared to baseline data using paired t-test.|At time of relapse or disease progression, assessed up to 12 months|Study participants were tested for these markers at baseline, but only IRF4 was re-tested at relapse|||participants|||Number
1449654|NCT00854581|Primary|Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy|"Number of participants achieving complete response (CR) with minimal residual disease at 3, 6 and 12 months post-initiation of protocol therapy. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009.~For imaging, Cheson criteria was used to assess response:~Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) < 4 x 10^9 /L.~Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood.~CR or PR had to persist for a period of at least 4 weeks."|3, 6 and 12 months.|Participants who achieved CR with minimal residual disease in Part 1 Maintenance therapy at Month 3 and moved on the Part 2B maintenance for up to 12 months.|||participants|||Number
1449655|NCT00854581|Primary|Number of Patients Achieving Clinical Response to Protocol Therapy Who Lack IRF-4 and/or c-Rel Expression.|"Number of patients achieving clinical response (complete response (CR) + partial response (PR)) who lack interferon regulatory factor 4 (IRF-4) or c-Rel biomarker expression. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009.~For imaging, Cheson criteria was used to assess response:~Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) < 4 x 10^9 /L.~Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood.~CR or PR had to persist for a period of at least 4 weeks."|Up to 12 months post-initiation of protocol therapy|All participants who had a treatment response (PR or CR)|||participants|||Number
1449656|NCT00854373|Secondary|Pregnancy|Fetal heart motion by transvaginal ultrasound|6 weeks after embryo transfer||||percentage of participants|||Number
1449657|NCT00854373|Secondary|Mature Oocyte Recovery Rate|Likelihood of obtaining an oocyte from a single mature-sized follicle on each ovary.|36 hours after hCG trigger||||percentage of follicles|||Number
1449658|NCT00854373|Primary|Mean Fertilization Proportion (2PN/Oocytes Collected)|Number of normally fertilized oocytes (2PNs) divided by the total number of oocytes collected (i.e., not just the number of inseminated MII oocytes). This accounted for the possibility of both an enhanced oocyte maturation and improved fertilization of the mature oocytes. This also permitted inclusion of both IVF and intracytoplasmic sperm injection (ICSI) cycles in a way that allowed for evaluation of collective fertilization rates (i.e., typically, the denominator in IVF in calculating fertilization rate is all eggs collected, but in ICSI it is calculated using only the number of MII oocytes injected).|24 hours after IVF or intracytoplasmic sperm injection (ICSI)|Intention to treat|||percentage of oocytes||Standard Deviation|Mean
1449659|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping).~Total non-nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The non-nasal population included only those participants with adequate non-nasal symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 6 or greater for the 24-hour reflective non-nasal symptom score, over the last 7 days of the Run-in Period.|||units on a scale||Standard Error|Least Squares Mean
1449660|NCT00854360|Secondary|Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period|"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping).~The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The ocular population included only those participants with adequate ocular symptoms during the Run-in Period as defined by a mean daily 24-hour reflective score of 4 or greater for the 24-hour reflective ocular symptom score, over the last 7 days of the Run-in Period.|||units on a scale||Standard Error|Least Squares Mean
1449695|NCT00853905|Secondary|Ocular Hypotensive Medications|Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.|1 week, 1 month, 3 month, and or 6 month post-op visits||||eye drops||95% Confidence Interval|Mean
1452247|NCT00835367|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1449661|NCT00854360|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates symptom improvement.|Baseline and Week 2|The RQLQ population included only those participants over the age of 18 years with an impaired quality of life at Baseline as defined by a RQLQ score at the Randomization Visit of 3.0 or greater.|||units on a scale||Standard Error|Least Squares Mean
1449662|NCT00854360|Secondary|Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period|Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement.|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
1449663|NCT00854360|Secondary|Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to the assessment, twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
1449664|NCT00854360|Primary|Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period|"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement."|Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)|The Intent-to-treat population included all randomized patients who received at least one dose of randomized study medication and had at least one post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
1449665|NCT00854308|Secondary|Duration of Overall Response||Date of initial response until date of progression or death on study. (Up to 20 months)|All randomized intent-to-treat patients. Analyses of duration of response were not performed because of the small number of patients with objective responses.||||||
1449666|NCT00854308|Primary|Progression-free Survival in Patients With Met Diagnostic-Positive Tumors|"Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry.~PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment)."|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-Positive tumors.|||months||95% Confidence Interval|Median
1449667|NCT00854308|Secondary|Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors|"Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry.~Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.~Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients with Met Diagnostic-positive tumors.|||Percentage of participants||95% Confidence Interval|Number
1449668|NCT00854308|Secondary|Percentage of Participants With Objective Response|"Objective response (partial and complete response as determined using RECIST 1.0).~Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.~Complete response was defined as disappearance of all target lesions."|Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)|All randomized intent-to-treat patients.|||Percentage of participants||95% Confidence Interval|Number
1449669|NCT00854308|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).|Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)|All randomized intent-to-treat patients.|||months||95% Confidence Interval|Number
1449670|NCT00854113|Primary|VZ/F|Pharmacokinetic results. Apparent volume of distribution|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||Liters||Standard Deviation|Mean
1449671|NCT00854113|Primary|CL/F|Pharmacokinetics results. Apparent oral clearance|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||L/hr||Standard Deviation|Mean
1449672|NCT00854113|Primary|Terminal Rate Constant.|Pharmacokinetics results. Terminal rate constant was estimated by linear regression of logarithmic transformed concentration versus time data|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||L/hr||Standard Deviation|Mean
1449673|NCT00854113|Primary|AUC 0 -24|Pharmacokinetics results. Area under the plasma concentration-time curve from time 0 to 24 hours post-dose.|Part-1 (Single dose) measured in 1 day and part 2 (multiple doses) measured in 14 days||||ng*hr/ml||Standard Deviation|Mean
1449678|NCT00854087|Primary|Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|"Efficacy of Fuzheng Huayu treatment was assessed through the change in liver fibrosis stage from the assessment before (pre) and after (post) study drug. The liver fibrosis staging system used was the Ishak scale. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.~Fibrosis improved was defined as a lower post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 3 or lower.~Fibrosis did not change was defined as having the same Ishak score before and after study drug assessments e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 4.~Fibrosis worsened was defined as a higher post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 5 or higher."|Baseline to Week 48|Participants who at least took one dose of study drug (Fuzheng Huayu or Placebo), were more than 80% compliant with study drug and had a pre and post study drug biopsy with an evaluable Ishak fibrosis score. Participants had ALT <300 and a BMI <40.|||participants|||Number
1449679|NCT00854087|Primary|Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy.|Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.|Baseline to Week 60|||||||
1449680|NCT00853996|Secondary|Reports of Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire|"The Health Assessment Questionnaire II (HAQ-II) measures interference in daily activities from arthralgias and joint pain. Range 0 - 4. A higher score indicates greater (i.e., worse) interference."|Baseline to up to 2 weeks post-treatment||||Participants|||Count of Participants
1449681|NCT00853996|Secondary|Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System|Problems with hot flashes were assessed by average number per day and intensity.|Baseline to up to 2 weeks post-treatment||||Participants|||Count of Participants
1449682|NCT00853996|Secondary|Change in Serum Concentration of Testosterone|Change in serum concentration of Testosterone from baseline to 6 months|Baseline to 6 months||||ng/ml||Standard Deviation|Mean
1449683|NCT00853996|Secondary|Change in Serum Concentration of Bioavailable Estradiol|Change in serum concentration of bioavailable estradiol (adjusted for concentration of Sex Hormone Binding Globulin), from baseline to 6 months|Baseline to 6 months||||pM||Standard Deviation|Mean
1449684|NCT00853996|Secondary|Change in Serum Estradiol Concentration|Change in serum concentration of estradiol from baseline to 6 months|Baseline to 6 months||||ng/ml||Standard Deviation|Mean
1449685|NCT00853996|Secondary|Change in Mammographic Breast Density|Change in mammographic density from baseline to 6 months, The Percent Breast Density is estimated using the Cumulus computer-assisted program to define a region that is at greater density than the remainder of the breast.|Baseline to 6 months|One subject was without a digital file due to technical reasons. Thus, only 24 subjects were evaluated.|||percentage of area at increased density||Inter-Quartile Range|Median
1449686|NCT00853996|Primary|Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months|Change in proliferation as measured by Ki-67 immunocytochemical expression in breast epithelial cells obtained by random periareolar fine needle aspiration at baseline and at 6 months.|Baseline to 6 months||||percentage of positive cells||Inter-Quartile Range|Median
1449687|NCT00853970|Secondary|Pain Free|Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.|Day 1|Last observation carried forward (LOCF) Analysis, Intent to treat (ITT) Population|||participants|||Number
1449688|NCT00853970|Primary|Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15 (Primary Endpoint)|Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population|||participants|||Number
1449689|NCT00853957|Secondary|Percentage of Patients With Peripheral Edema by Visit|Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.|8 weeks|Full Analysis Set|||Percentage of participants|||Number
1449690|NCT00853957|Secondary|Change From Baseline in MSSBP at Week 1 and 4|Compare the change from baseline in MSSBP at week 1 and 4|Baseline, 1 and 4 weeks|Full analysis set, Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1449691|NCT00853957|Secondary|Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)|Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set|||Percentage of participants|||Number
1449692|NCT00853957|Secondary|Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)|Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Full analysis set|||Percentage of participants|||Number
1449693|NCT00853957|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).|Baseline, 8 weeks|Full analysis set, Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1449696|NCT00853905|Secondary|Patient Comfort|Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale.|1 day, 1 week, 1 month, 3 month and 6 month post-op visits||||Patient comfort questionnaire score||95% Confidence Interval|Mean
1449697|NCT00853905|Secondary|Bleb Appearance|A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery.|1 day, 1 week, 1 month, 3 month and 6 month post-op visits|Bleb assessment by IBAGS was not obtained at all visits. Overall, 20 of 37 (Triesence) and 20 of 40 (BSS) blebs were measured.|||units on a scale||95% Confidence Interval|Mean
1449698|NCT00853905|Secondary|Anterior Chamber Inflammation (Flare)|Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec).|1 month, 3 month and 6 month post-op visits||||photon counts per millisecond (p/msec)||95% Confidence Interval|Mean
1449699|NCT00853905|Primary|Intraocular Pressure (IOP)|Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.|1 day, 1week, 1 month, 3 month and 6 month post-op visits||||mm Hg||95% Confidence Interval|Mean
1449700|NCT00853840|Secondary|Number of Subjects With Postural Hypotension|Postural (orthostatic) hypotension defined as 1) decrease in standing-supine diastolic blood pressure (BP) greater than or equal to 10 mm Hg; 2) decrease in standing-supine systolic BP greater than or equal to 20 mm Hg; or 3) standing systolic BP less than 90 mm Hg. Assessed at Period 1 and Period 2 BP measurement timepoints post maraviroc dose.|Period 1 and Period 2 (up to 8 days)|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||participants|||Number
1449701|NCT00853840|Secondary|Postural Changes in Pulse Rate|Postural change calculated as position 1 (standing) value minus position 2 (supine) value. Baseline was the average of the 3 predose measurements at each period. Means of Replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||beats per minute (bpm)||Standard Deviation|Mean
1449702|NCT00853840|Secondary|Postural Changes in Systolic and Diastolic Blood Pressure|Postural change calculated as position 1 (standing) value minus the position 2 (supine) value. Baseline was the average of 3 predose measurements at each period. Means of replicates were used in calculations.|Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||mm Hg||Standard Deviation|Mean
1449703|NCT00853840|Secondary|Standing and Supine Pulse Rate|Supine pulse rate measurement was taken after subject rested for 5 minutes supine. Subject sat for 2 minutes, then stood for 2 minutes and standing measurement taken. Duplicate supine and standing pulse rate measurements taken per protocol. Average of duplicate measurements calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1449704|NCT00853840|Primary|Standing and Supine Systolic and Diastolic Blood Pressure (BP)|Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis.|1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose|The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.|||mm Hg||Standard Error|Least Squares Mean
1449705|NCT00853827|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.|104 weeks|Safety - All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received|||Number of patients|||Number
1449706|NCT00853827|Secondary|Patients That Demonstrated Evidence of Atheroma Regression|Atheroma regression is defined as change from baseline to endpoint in PAV <0 .|Baseline to endpoint (104 weeks)|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization|||Participants|||Number
1449707|NCT00853827|Secondary|Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS|Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.|||mm^3||Standard Error|Least Squares Mean
1449720|NCT00853762|Primary|Change From Baseline in Vital Signs: Temperature||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.|||Degree Celsius||Standard Deviation|Mean
1449769|NCT00853593|Primary|Efficacy: Proximal Ring Voltage Threshold|Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.|Three months|Subjects with ring electrode threshold captured at 0.5 ms at 3-month|||Volts||Standard Deviation|Mean
1449708|NCT00853827|Primary|Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment|Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases|Baseline, 104 weeks|Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization. All patients who had a valid baseline and post baseline IVUS measurement and post-baseline IVUS measurement and at least ≥72 weeks of treatment were included in this analysis.|||percentage of baseline||Standard Error|Least Squares Mean
1449709|NCT00853762|Primary|Number of Subjects With Positive Neutralizing Antibody (NAb)||Baseline, Week 12 and 36|Appropriate method/test was not established to identify the positive neutralizing antibodies for atacicept. Hence, this outcome measure was not assessed.||||||
1449710|NCT00853762|Secondary|Pharmacogenetics/Pharmacogenomics Analysis|"Gene expression profiling and gene polymorphism identification were to be used to identify putative markers for response to treatment.~Genome-wide gene polymorphism characterization by genome-wide scan.~Targeted gene polymorphism identification of B-Lymphocyte Stimulator (BLyS) , APRIL, (receptor for B cell activating factor of the tumor necrosis factor [TNF] family) BAFF-R, (Transmembrane Activator) TACI and (B Cell Maturation Antigen) BCMA and HLA-DRB1 by direct genotyping or sequencing ."|Day 1 and Week 36|Genetic/genomic analysis was not performed as the trial was terminated early.||||||
1449711|NCT00853762|Secondary|Free B-Lymphocyte Stimulator (BLyS) and Free A Proliferation-Inducing Ligand (APRIL) Serum Concentrations.|Levels of free APRIL and free BLyS: Free APRIL serum samples were to be analyzed by using a validated enzyme-linked immunosorbent assay (ELISA) with limits of detection of 0.3125 nanogram per milliliter (ng/mL) for free APRIL and free BlyS serum samples were analysed using a validated ELISA with limits of detection of 1.56 ng/mL.|Baseline, Week 12 and 36|This outcome measure was not assessed due to lack of a valid assay for measuring BLyS and APRIL.||||||
1449712|NCT00853762|Secondary|Concentrations of Free and Total Atacicept||Baseline and Week 12|This outcome measure was not assessed due to lack of a valid assay during the usable time period of the samples.||||||
1449713|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions (New or Enlarging T2 Lesions) Per Subject||Baseline, Week 12 and Week 24||||Cubic millimeter||Standard Deviation|Mean
1449714|NCT00853762|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Number of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject||Baseline, Week 12 and 24|Intent-to-treat (ITT) population included all randomized subjects. “n” signifies the number of evaluable subjects for this outcome measure.|||Number of lesions per subject||Standard Deviation|Mean
1449715|NCT00853762|Secondary|Change in Multiple Sclerosis Functional Composite (MSFC) Score at Week 12|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies number of evaluable subjects for this outcome measure."|||z-score||Standard Deviation|Mean
1449716|NCT00853762|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 12|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.|Baseline, Week 12|"Intent-to-treat (ITT) population included all randomized subjects. N signifies (total number of subjects analyzed) the number of evaluable subjects for this outcome measure."|||Units on a scale||Standard Deviation|Mean
1449717|NCT00853762|Secondary|Number of Subjects With Clinical Attacks/Relapses|"A clinical attack/relapse was defined as the fulfillment of all the following criteria:~Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours.~Absence of fever or known infection (fever with temperature (axillary, orally, or intra-auriculary) > 37.5°C/99.5 °Fahrenheit).~Objective neurological impairment, correlating with the subject’s reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. EDSS overall score ranging from 0 (normal) to 10 (death due to MS) was calculated."|Baseline up to Week 24|Intent-to-treat (ITT) population included all randomized subjects.|||Subjects|||Number
1449718|NCT00853762|Primary|Number of Subjects With Worsened Post Baseline Shift in Immunoglobulin A (IgA), IgG and IgM Levels|Number of subjects with shifts from normal Grade (Grade 0) at Baseline to worse value at post-baseline (Grade 1 to Grade 4) according to the following criteria: IgA Grade 0: greater than or equal to (>=) lower limit normal (LLN) 0.7 gram per liter (g/L); Grade 1: less than (<) LLN - 0.5 g/L, Grade 2: <0.5g/L -0.3 g/L, Grade 3: <0.3 g/L -0.1 g/L, Grade 4: < 0.1 g/L; IgG Grade 0: >= LLN (7 g/L), Grade 1: < LLN - 5 g/L, Grade 2: <5g/L -4 g/L, Grade 3: <4 g/L -3 g/L and Grade 4: < 3 g/L; IgM Grade 0: >= LLN (0.4 g/L), Grade 1: < LLN - 0.3 g/L, Grade 2: <0.3 g/L -0.2 g/L, Grade 3: <0.2 g/L -0.1 g/L, and Grade 4: < 0.1 g/L are presented in this outcome measure.|Baseline up to Week 36|Intent-to-treat (ITT) population included all randomized subjects.|||Subjects|||Number
1449719|NCT00853762|Primary|Change From Baseline in Electrocardiogram (ECGs)||Baseline, Week 12 and 36|No summary tables were prepared for ECG parameters, and ECG data were not formally analyzed. However, a qualitative assessment of ECG morphology and rhythm was made by the Investigator and recorded in the electronic case report form (eCRF). ECG abnormalities considered significant by the investigator were reported as AEs.||||||
1452624|NCT00833690|Primary|Safety|Defined as absence of serious adverse experiences (SAEs) that warranted terminating an inosine treatment arm or the trial, as determined by the Data and Safety Monitoring Committee.|24 months||||Events|||Number
1449721|NCT00853762|Primary|Change From Baseline in Vital Signs: Pulse Rate||Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.|||beats per minute (beats/min)||Standard Deviation|Mean
1449722|NCT00853762|Primary|Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure (systolic and diastolic) was measured after at least 3 minutes resting, with the subject in the seated position.|Baseline, Week 2, 4, 8, 12, 16, 20, 24 and 36|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study. Here 'n' signifies those subjects who were evaluable for the specified category.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
1449723|NCT00853762|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Injection Site Reactions, Infections, and Malignancies by Severity|TEAEs were defined as AEs with a start date after or on the date of the first DB treatment injection in ATAMS Extension and that occurred anytime after treatment discontinuation, or up to the day before first Rebif® rescue medication injection in ATAMS Extension. A serious TEAE was an AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE severity was graded as per Qualitative Toxicity Scale. Local injection site reactions (injection site: pain, redness, itching and swelling) throughout ATAMS Extension, starting after the first trial medication administration. If the subject experienced 1 or more of the above injection site symptoms, these were reported with the AE verbatim term “injection site reaction”. For all randomized subjects, there was an option of rescue treatment with Rebif® for 1 year beginning with the first injection of Rebif®).|From the first dose of study drug administration up to Week 24|Double-blind safety analysis set included all the subjects who received at least 1 dose of trial medication in the ATAMS extension study.|||Subjects|||Number
1449724|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination|Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 4|Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic|||Percentage of participants|||Number
1449725|NCT00853749|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Particpants may have been represented in more than 1 category.|Day 1 through Day 4|Safety Population: all participants who receive at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic|||Percentage of participants|||Number
1449726|NCT00853749|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination|Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all particpants with available data for the specified blood draw.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1449727|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (OPA)|Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate antibody titre to the specified serotype.|||GMT||95% Confidence Interval|Geometric Mean
1449728|NCT00853749|Secondary|Antibody Response Measured 1 Month After Vaccination (Avidity Assay)|Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).|Day 28|Evaluable Immunogenicity Population; In accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10. N=number of participants with a determinate avidity index for the specified serotype.|||AI||95% Confidence Interval|Geometric Mean
1449729|NCT00853749|Primary|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination|Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
1449730|NCT00853749|Primary|Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination|Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|Day 28|Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of participants||95% Confidence Interval|Number
1449731|NCT00853723|Secondary|Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)|"Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP < or = 0.86 then TMP/GFR = TRP x P phos if TRP > 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos~U= urine, P = plasma"|Baseline, Day 15, Day 30, Day 60, Day 90||||mg/dl||Standard Error|Mean
1449732|NCT00853723|Secondary|Fractional Excretion of Calcium|(Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)|Baseline, Day 15, Day 30, Day 60, Day 90||||% excreted||Standard Error|Mean
1449733|NCT00853723|Secondary|1,25 Vitamin D||Baseline, Day 15, Day 30, Day 60, Day 90||||pg/ml||Standard Error|Mean
1449734|NCT00853723|Secondary|24 Hour Urine Calcium||90 days||||mg/gm creatinine||Standard Error|Mean
1449735|NCT00853723|Secondary|Serum Phosphorous||Baseline, Day 15, Day 30, Day 60, Day 90||||mg/dl||Standard Error|Mean
1449736|NCT00853723|Secondary|Total Serum Calcium (mg/dl)||Baseline, Day 15, Day 30, Day 60, Day 90||||mg/dl||Standard Error|Mean
1449737|NCT00853723|Secondary|Changes in Bone Mineral Density of the Distal 1/3 Radius.||90 days||||Percent change from baseline||Standard Error|Mean
1449738|NCT00853723|Secondary|Changes in Bone Mineral Density of the Forearm.||90 days||||Percent change from baseline||Standard Error|Mean
1449739|NCT00853723|Secondary|Changes in Bone Mineral Density of the Femoral Neck.||90 days||||Percent change from baseline||Standard Error|Mean
1449740|NCT00853723|Secondary|Changes in Bone Mineral Density of the Total Hip.||90 days||||Percent change from baseline||Standard Error|Mean
1449741|NCT00853723|Primary|Carboxy-terminal Telopeptides of Collagen-1 (CTX)||Baseline, Day 15, Day 30, Day 60, Day 90||||percentage change from baseline||Standard Error|Mean
1449742|NCT00853723|Secondary|Changes in Bone Mineral Density of the Lumbar Spine.||90 days||||Percent change from baseline||Standard Error|Mean
1449743|NCT00853723|Primary|Procallagen-1 Amino-terminal Peptide (P1NP)||Baseline, Day 15, Day 30, Day 60, Day 90||||percentage change from baseline||Standard Error|Mean
1449744|NCT00853658|Secondary|All Cause Death|Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.|up to end of study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations|||participants|||Number
1449745|NCT00853658|Secondary|Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score|Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline, Month 12|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.|||KCCQ Score||Standard Error|Least Squares Mean
1449746|NCT00853658|Primary|Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization|Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.|up to End of Study (78 months)|Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.|||participants|||Number
1449747|NCT00853606|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.|Baseline, End of Treatment|Number of participants analyzed represents the Intent-to-Treat population. For dropouts of missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Deviation|Mean
1449748|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents to Intent-to-Treat population.|||percentage of sexual attempts||Standard Deviation|Mean
1449749|NCT00853606|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.|"Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse? Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit."|Baseline, 52 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Deviation|Mean
1449750|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing|Bipolar sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here.|6 month|Subjects with bipolar configuration electrode R-wave amplitude at 6 month.|||mV||Standard Deviation|Mean
1449751|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance|Subjects' bipolar pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with bipolar configuration pacing impedance at 6 month|||Ohms||Standard Deviation|Mean
1449752|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold|Bipolar voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is reported here.|6 month|Subjects with bipolar configuration threshold captured at 0.5 ms at 6 month|||Volts||Standard Deviation|Mean
1449753|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing|Ring electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected only at the implant procedure because the devices allowed in this study are not programmable to collect sensing measurements using the ring electrode. The analyzer was used to collect measurements.|During implant procedure.|Subjects with ring electrode R-wave amplitude at implant|||mV||Standard Deviation|Mean
1449754|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance|Subjects' ring electrode pacing impedance was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with ring electrode pacing impedance at 6 month|||Ohms||Standard Deviation|Mean
1449755|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold|Ring electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold at the 6 month visit is presented here.|6 month|Subjects with ring electrode threshold captured at 0.5 ms at 6 month|||Volts||Standard Deviation|Mean
1449756|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing|Tip electrode sensing, measured by R-wave amplitude, for the Model 4396 was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Measurements at the 6 month visit are presented here. Sensing is the minimum energy produced by the left ventricle of the heart that the device can sense.|6 month|Subjects with tip electrode R-wave amplitude at 6 month|||mV||Standard Deviation|Mean
1449757|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance|Subjects' tip electrode pacing impedance (a measure of electrical resistance) was measured at implant, pre-hospital discharge and all scheduled follow-up visits. Pacing impedance at the 6 month visit is presented here.|6 month|Subjects with tip electrode pacing impedance at 6 month|||Ohms||Standard Deviation|Mean
1449758|NCT00853593|Secondary|Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold|Tip electrode voltage threshold at 0.5 ms was collected at implant, pre-hospital discharge and all scheduled follow-up visits. Voltage threshold values at the 6 month visit are summarized.|6 month|Subjects with tip electrode threshold captured at 0.5 ms at 6 month|||Volts||Standard Deviation|Mean
1449759|NCT00853593|Secondary|Efficacy: Bipolar Voltage Threshold|Subjects' voltage threshold in the bipolar configuration was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold (at 0.5 milliseconds [ms]) is less than or equal to 4.0 Volts.|1 month|Subjects that were implanted with a Model 4396 lead and completed the 1 month visit|||Volts||Standard Deviation|Mean
1449760|NCT00853593|Secondary|Assessment of Lead Handling Characteristics Reported as Acceptable|Implant lead handling characteristics were qualitatively assessed through physician feedback on the Implant Case Report Form (CRF). Physicians were asked for their overall assessment of the lead and results were categorized as acceptable or unacceptable. The number of acceptable responses are summarized.|During implant procedure.|Subjects who underwent a Model 4396 left ventricular lead implant attempt.|||participants|||Number
1449761|NCT00853593|Secondary|Total Operation Time|Total operation time was defined as time from initial incision to final closure.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.|||minutes||Standard Deviation|Mean
1449762|NCT00853593|Secondary|Model 4396 Lead Placement Time|Model 4396 lead placement time was defined as the time from insertion of the successfully implanted lead to the time when it was placed in the first acceptable pacing location.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's LV Lead placement time was permanently missing and a study deviation was reported.|||minutes||Standard Deviation|Mean
1449763|NCT00853593|Secondary|Fluoroscopy Time|The total time the fluoroscope was imaging (not including biplane fluoroscopy time).|During implant procedure.|Subjects successfully implanted with a Model 4396 lead. Note that one subject's standard fluoroscopy time was not collected and a study deviation was reported.|||minutes||Standard Deviation|Mean
1449764|NCT00853593|Secondary|Cannulation Time|Cannulation time was defined as the time from insertion of the first coronary sinus (CS) cannulation catheter to the first successful CS cannulation.|During implant procedure.|Subjects successfully implanted with a Model 4396 lead.|||minutes||Standard Deviation|Mean
1449765|NCT00853593|Secondary|Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead|A successful implant occurs when any Medtronic Attain Family LV Lead is implanted in a left ventricular vein and functions appropriately. The Attain Family leads include the following models: 4193, 4194, 4195, 4196, and 4396.|During implant procedure.|Subjects who underwent an implant attempt.|||participants|||Number
1449766|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead|A successful implant occurs when any transvenous LV lead is implanted in a left ventricular vein functions appropriately.|During implant procedure.|Subjects who underwent an implant attempt.|||participants|||Number
1449767|NCT00853593|Secondary|Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation|A successful implant after cannulation occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead (any transvenous LV lead) is implanted in a left ventricular vein and functions appropriately. An implant attempt of any transvenous LV lead was defined as any time when a transvenous LV lead was introduced into the body.|During implant procedure.|Subjects with successful CS cannulation after an implant attempt.|||participants|||Number
1449768|NCT00853593|Secondary|Subjects Successfully Implanted With Model 4396 Lead|A successful implant occurs when the Model 4396 lead is implanted in a left ventricular vein and functions appropriately. A Model 4396 implant attempt was defined as any time when a Model 4396 lead was introduced into the body.|During implant procedure.|Subjects who underwent Model 4396 LV implant attempt.|||participants|||Number
1449841|NCT00853333|Primary|Pain Rating Change|"Mechanical Slide Algometer (www.decisionaidsonline.com), Range: No Pain Sensation (1) to  Most Intense Sensation Imaginable (10) 10 point scale.~Change Time Points: Baseline (no sedation), Sedation. Same Day Intervention."|Sedation||||units on a scale||Standard Error|Least Squares Mean
1449770|NCT00853593|Primary|Efficacy: Distal Tip Electrode Voltage Threshold|Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds [ms]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.|One month|Only subjects with pacing thresholds captured at 0.5 ms were included in the analysis.|||Volts||Standard Deviation|Mean
1449771|NCT00853593|Primary|Safety (Subjects Without a Model 4396 Lead Related Complication)|A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).|One month|Subjects who underwent a Model 4396 left ventricular (LV) lead implant attempt and had a 1 month follow-up visit.|||participants|||Number
1449772|NCT00853580|Secondary|Psychosocial Quality of Life PedsQL|Self-rated questionnaire of psychosocial Quality of Life (including emotional, social and school functioning). Summary scores are reported. Higher scores indicate higher quality of life (range 0-100).|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
1449773|NCT00853580|Secondary|Quality of Life Pediatric Quality of Life Inventory (PedsQL)|Parent-rated questionnaire of psychosocial Quality of Life (including emotional, social and school functioning). Summary scores are reported. Higher scores indicate increased increased quality of life (range 0-100).|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
1449774|NCT00853580|Secondary|Internalizing Behaviors, Behavior Assessment System for Children Second Edition|A self-reported questionnaire assessing internalizing behaviors such as anxiety and depression. T-scores are reported. Higher scores indicate increased internalizing behaviors. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
1449775|NCT00853580|Secondary|Internalizing Behaviors, Behavior Assessment System for Children Second Edition|A parent-reported questionnaire assessing internalizing behaviors of anxiety, depression and somatization. T-scores are reported. Higher scores indicate increased internalizing behaviors. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
1449776|NCT00853580|Secondary|Object Assembly (WISC-III)|A measure of visuoperceptual organization. Participants were required to rebuild an item puzzle based on disassembled pieces. Age scaled scores are reported, which have a population mean of 10 and standard deviation of 3 (range 1-19). Higher scores indicate better performances.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
1449777|NCT00853580|Secondary|Behavior Rating Inventory of Executive Function Global Executive Composite|A parent-rated questionnaire of executive behaviour assessing behavioral regulation (inhibit, shift, emotional control) and metacognition (initiate, working memory, plan/organize, organization of materials, self-monitoring). T-scores for the Global Executive Composite (overall summary score) are reported. Higher scores indicate poorer executive behaviors.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
1449778|NCT00853580|Secondary|Judgement of Line Orientation Test|A test of visuospatial judgement. The test measured the participant's ability to match the angle and orientation of lines in space. There were 30 trial in total. Correct response in a trial was awarded one point (range 0-30). Higher scores represent better performances. Raw data are reported.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Total correct responses||Standard Deviation|Mean
1449779|NCT00853580|Secondary|Controlled Oral Word Association Test|A measure of verbal fluency. Participants were required to spontaneously produce as many words as they could, beginning with a designated letter in 60 seconds. Three letters were used. Higher scores represent better performances. Raw data are reported summing total words generated for all three letters. Scale does not have a maximum range.|Baseline and Post-treatment (week 16)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Total words||Standard Deviation|Mean
1449852|NCT00853242|Secondary|Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22||Baseline, Day 22|Full Analysis Set.|||mg^2/dL^2||Standard Deviation|Mean
1449853|NCT00853242|Secondary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)||Baseline, Day 22|FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure <= 3 days after date of last study drug.|||mg/dL||Standard Deviation|Mean
1449780|NCT00853580|Secondary|ADHD Hyperactive/Impulsive Scale, Conners ADHD Scales|Parent rated hyperactive/impulsive ADHD symptoms, based on Diagnostic and Statistical Manual of Mental Disorders criteria, 4th edition.T-scores are reported. Higher scores indicate increased ADHD-related symptoms. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
1449781|NCT00853580|Secondary|ADHD Inattentive Scale, Conners ADHD Scales|Parent rated inattentive ADHD symptoms, based on Diagnostic and Statistical Manual of Mental Disorders criteria, 4th edition. T-scores are reported. Higher scores indicate increased ADHD-related symptoms. A score below 60 is considered healthy, 61-65 a possible significant problem, and 66+ is considered a significant problem.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
1449782|NCT00853580|Secondary|Omission Errors (Conners Continuous Performance Test, Second Edition; CPT-II)|A computerised measure of vigilance and concentration. Letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter ‘X’ which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Omission errors represented the number of times a participant fails to respond to target letters (all other than ‘X’). T-scores are reported, as generated by the test software. Higher scores indicate poorer performances.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
1449783|NCT00853580|Secondary|Commission Errors (Conners Continuous Performance Test, Second Edition; CPT-II)|A computerised measure of impulse control. Letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter ‘X’ which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Commission errors represented the number of times a participant incorrectly responded to the non-target (letter ‘X’). T-scores are reported, as generated by the test software. Higher scores indicate poorer performances.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||T score||Standard Deviation|Mean
1449784|NCT00853580|Secondary|Creature Counting (Test of Everyday Attention for Children)|"Creature Counting is a measure of attentional control. Participants were required to count creatures from top of the page to the bottom, using arrows as cues to switch from counting up to counting down (and vice versa). There were seven testing trials. The outcome variable was the total number of correct trials (range 0-7). Higher scores represent better performances."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
1449785|NCT00853580|Secondary|Sky Search DT (Test of Everyday Attention for Children)|Sky Search DT is a test of divided attention. Children completed a parallel version of the Sky Search subtest while at the same time, silently counted the number of tones in a similar way to the Score! subtest. Higher scores represent poorer performance. Raw data are reported. Scale does not have a maximum range.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
1449786|NCT00853580|Secondary|Sky Search (Test of Everyday Attention for Children)|Sky Search is a measure of selective visual attention. Participants were presented with a A3 sheet with target stimuli (spaceships in identical pairs) randomly distributed among many distractors (spaceships in non-identical pairs). They were required to circle as many of the targets as possible as quickly as possible. The outcome measure (attention score), was a timing score reflecting the average time taken per target found. Higher scores represent poorer performance. Raw data are reported. Scale does not have a maximum range.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Scores on a scale||Standard Deviation|Mean
1449787|NCT00853580|Secondary|Stop Signal Task (Cambridge Neuropsychological Test Automated Battery)|"A computerized measure of inhibitory control. The participant quickly responded to an arrow stimulus by pressing one of two buttons (left or right), depending on the direction in which the arrow pointed on the screen. If an audio tone is present, the subject was supposed to withhold the response.~The difficulty of the task was manipulated by altering the delay before a stop signal (auditory tone) was presented, known as the stop signal delay. The outcome from this measure was stop signal reaction time (last half of test), which was computed by subtracting the mean stop signal delay at which the participant was able to stop on 50% of trials from the mean reaction time on go trials. Poorer response inhibition was reflected by a larger stop signal reaction time. Scale does not have a maximum range."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Milliseconds||Standard Deviation|Mean
1449854|NCT00853242|Primary|Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)||Baseline, Day 22|Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (<=) 3 days after date of last study drug.|||mg/dL||Standard Deviation|Mean
1449788|NCT00853580|Secondary|Stockings of Cambridge (Cambridge Neuropsychological Test Automated Battery) Automated Battery).|"A computerized measure of spatial planning based on the Tower of London test. It required participants to move balls in a lower display to match a pattern shown in the upper display in a certain number of moves.~More specifically, the participant was shown two displays containing three coloured balls. The displays were presented in such a way that they could be perceived as stacks of coloured balls held in socks suspended from a beam. The test administrator first demonstrated to the participant how to move the balls in the lower display to copy the pattern in the upper display and completed one demonstration problem, where the solution required one move. The participant then completed problems that increased in difficulty, from one through to five move problems.~The unit of measure was the mean number of moves taken to complete a problem that could not be completed in less than five moves. The higher the score, the poorer the performance (range 5-12)."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Moves||Standard Deviation|Mean
1449789|NCT00853580|Secondary|Spatial Working Memory (Cambridge Neuropsychological Test Automated Battery)|"A computerized measure of spatial working memory. This task assessed the participant’s ability to retain spatial information and to manipulate remembered items in working memory.~In this test, participants were shown an array of boxes on a computer screen and they were required to search through the boxes for hidden tokens. One box at a time was touched until a blue token was found inside. Participants then commenced a new search for the next token. The key instruction was that, once a token had been located, that box would not be used again to hide another token.~Unit of measure was between search errors, determined by the number of boxes a participant reopens in which a token had previously been found. Higher score indicated poorer performance. Scale does not have a maximum range."|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Errors||Standard Deviation|Mean
1449790|NCT00853580|Primary|Score! (Test of Everyday Attention for Children)|Score! is a measure of sustained attention. Participants were required to silently count a series of aurally presented tones and say the total number of tones counted at the end of each trial. The number of tones ranged from 9 to 15, with a total of 10 trials (range 0-10). Higher values represent better performance.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||Units on a scale||Standard Deviation|Mean
1449791|NCT00853580|Primary|Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery).|A computerized test of visuospatial learning. Participants had to remember patterns associated with different locations on the screen, and during the test phase, as each pattern is presented, point to the appropriate location. The test starts at a very simple level and gradually increases in difficulty. Higher number of errors indicates poorer performance. Scale does not have a maximum range.|Baseline and Post-treatment (16 weeks)|Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations).|||PAL Total Errors||Standard Error|Mean
1449792|NCT00853567|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated||||||
1449793|NCT00853489|Secondary|Medical Cost|An economic evaluation will also be performed including the costs of iliac crest bone graft harvest and complications from the bone graft surgery and the cost of the Rh-BMP 2 and the biologic implant used in the treatment group.|12 mos post op|Hospital bills for bone graft surgery admission were available on 25 patients total|||dollars for total admission cost||Full Range|Mean
1449794|NCT00853489|Secondary|Infection|Infection will be assessed based on the CDC criteria for deep and superficial infection.|12 months post op.|Infection was decribed in protocol|||Participants|||Count of Participants
1449795|NCT00853489|Primary|Fracture Healing (Union) at 12 Months|"Union will be defined by:~1. Radiographic union as defined by the Radiographic union scale in tibia fractures (RUST) score, Radiographic evaluation will be assessed by blinded orthopaedic surgeons."|12 months post op|RUST scores were used to determine radiograpghic union at 52 weeks|||Participants|||Count of Participants
1449796|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449797|NCT00853385|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449798|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
1449799|NCT00853385|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||hours per day||Standard Deviation|Mean
1449800|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||days||Standard Deviation|Mean
1449801|NCT00853385|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||days||Standard Deviation|Mean
1449802|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||events||Standard Deviation|Mean
1449803|NCT00853385|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||events||Standard Deviation|Mean
1449804|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12|RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449805|NCT00853385|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.|Baseline, Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449806|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline, Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449855|NCT00853229|Secondary|Effect on Anxiety and Depression in Women With Vulvodynia Based on the Kessler Psychological Distress Scale (K10)|Data not measured due to early discontinuation of the study prior to the designated follow up time frame.|4 weeks|||||||
1452625|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Baseline Visit||||mg/dL||Standard Deviation|Mean
1449807|NCT00853385|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).|Month 3, 6|FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449808|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449809|NCT00853385|Secondary|Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449810|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.|||participants|||Number
1449811|NCT00853385|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||participants|||Number
1449812|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449813|NCT00853385|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449856|NCT00853229|Primary|Reduction in Average Pain Over the Last 7 Days of Each Arm Using an 11-point Scale (0-10)|Outcomes measure not assessed due to early discontinuation because of poor recruitment. As such, the study was terminated prior to the designated follow up interval. Therefore, no outcomes data was collected.|4 weeks|||||||
1449814|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1449815|NCT00853385|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6|FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449816|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9 and 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449817|NCT00853385|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449818|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1449819|NCT00853385|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1449820|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1449821|NCT00853385|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1449822|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Month 9 and 12|Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1449823|NCT00853385|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||mm||Standard Deviation|Mean
1449824|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449825|NCT00853385|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449826|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.||||||
1449827|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12|Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.||||||
1449828|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449829|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449830|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449831|NCT00853385|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449832|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
1449833|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
1449834|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
1449835|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3, 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
1449836|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 9, 12|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
1449837|NCT00853385|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3|ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 1, 3|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.|||percentage of participants|||Number
1449838|NCT00853385|Primary|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).|||percentage of participants|||Number
1449839|NCT00853385|Primary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1449840|NCT00853385|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20% improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full analysis set: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.|||percentage of participants|||Number
1449842|NCT00853307|Secondary|Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events|Laboratory tests included Hematology and Chemistry. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months|Safety Population is defined as all participants who received any amount of alisertib.|||participants|||Number
1449843|NCT00853307|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events|Vital signs included blood pressure, pulse rate, and oral temperature collected throughout the study. . A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline, Cycle 1 Days 8 and 15, then Day 1 of every cycle (21 days), End of Treatment, End of Study/FU every 12 weeks for up to 12 months (Up to 22 Months)|Safety Population is defined as all participants who received any amount of alisertib.|||participants|||Number
1449844|NCT00853307|Secondary|Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose to 30 days past last dose (Up to 18.9 Months)|Safety Population is defined as all participants who received any amount of alisertib.|||participants|||Number
1449845|NCT00853307|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as the percentage of participants with response and stable disease (SD), where in order for SD to qualify as having clinical benefit, there must be no progression of neoplastic disease for at least 4 treatment cycles.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and receive at least 1 dose of alisertib and have at least 1 post-baseline response assessment|||percentage of participants|||Number
1449846|NCT00853307|Secondary|Time To Progression (TTP)|TTP is defined as the time in days from the date of first study drug administration to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Due to study termination, there was insufficient data to perform this analysis.||||||
1449847|NCT00853307|Secondary|Duration Of Response (DOR)|DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Due to study termination, there was insufficient data to perform this analysis.||||||
1449848|NCT00853307|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documented Progressive Disease (PD) or death. PD is defined as 20% increase in the sum of the longest diameter of target lesions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. For a participant who has not progressed and has not died, PFS is censored at the last response assessment that is stable disease (SD) or better.|Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Response-evaluable population is defined as all participants who have measurable neoplastic disease according to RECIST criteria OR participants with CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.|||days||95% Confidence Interval|Median
1449849|NCT00853307|Primary|Combined Best Overall Response Rate Based on Investigator Assessment|Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).|Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)|Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/milliliter (mL) and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.|||percentage of participants|||Number
1449850|NCT00853242|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1449851|NCT00853242|Secondary|Change From Baseline in Total Cholesterol at Day 22||Baseline, Day 22|Full Analysis Set.|||mg/dL||Standard Deviation|Mean
1449857|NCT00853151|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) at 3-Week and 6-Month Endpoints|Values from repeated measures include fixed categorical effects of treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate of baseline HOMA derived beta-cell function (HOMA-B). HOMA=index of function of cells that make insulin. Indices derived from fasting glucose and insulin concentrations. HOMA is measurement reflecting fasting plasma glucose and insulin. Has no defined minimum/maximum value. HOMA-B values generated from table reflecting values derived from Oxford HOMA2 model calculator. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline HOMA value.|||units on a scale||Standard Error|Least Squares Mean
1449858|NCT00853151|Secondary|Change From Baseline in Fasting Insulin at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline Fasting Insulin. Fasting insulin is the Mixed-Meal Tolerance Test (MMTT) insulin assessment at timepoint 0, where available, otherwise it is the assessment taken from the fasting laboratory measurements obtained during the clinic visit. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline fasting insulin value.|||microinternational units/milliliter||Standard Error|Least Squares Mean
1449859|NCT00853151|Secondary|Number of Participants With Adjudicated and Confirmed Deaths and Non-Fatal Cardiovascular (CV) Events at Any Timepoint|The protocol specified that deaths and nonfatal cardiovascular (CV) adverse events (AEs) be adjudicated by independent physician(s) with cardiology or neurology experience. The CV AEs to be adjudicated were protocol-defined as myocardial infarction (MI), hospitalization for unstable angina or for heart failure, coronary interventions (coronary artery bypass graft or percutaneous coronary intervention [PCI]) and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack (TIA). 3 CV events were adjudicated by an external independent adjudication committee.|Baseline (Week -1) through 6 months|All participants who received at least 1 dose of TT223 or its placebo.|||participants|||Number
1449860|NCT00853151|Secondary|Number of Participants With Hypoglycemia|The number of participants for whom low blood glucose was reported. Hypoglycemia ≥1 events including: severe hypoglycemia(glucose <50mg/dL, unable to treat self or recover after treatment); documented symptomatic (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms); asymptomatic (glucose ≤70mg/dL no symptoms); probable symptomatic (glucose missing, adrenergic or neuroglycopenic symptoms); relative (glucose >70mg/dL, adrenergic or neuroglycopenic symptoms), nocturnal (glucose ≤70mg/dL, adrenergic or neuroglycopenic symptoms between bedtime/waking).|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||participants|||Number
1449861|NCT00853151|Secondary|Percentage of Participants With Hypoglycemia|Calculation of frequency of low glucose for time period. Hypoglycemia≥1 events: severe<50mg/dL, unable to treat self/recover after treatment; documented symptomatic≤70mg/dL, adrenergic/neuroglycopenic symptoms; asymptomatic≤70mg/dL no symptoms; probable symptomatic glucose missing, adrenergic/neuroglycopenic symptoms; relative>70mg/dL, adrenergic/neuroglycopenic symptoms, nocturnal≤70mg/dL, adrenergic/neuroglycopenic symptoms between bedtime/waking. Because number participants who experienced hypoglycemia was low for every arm (1-3/arm) did not model percentage participants with hypoglycemia.|Baseline (Week -1) through 6 months|Because the number of hypoglycemia events were too low to model the percentage of hypoglycemia, zero participants were analyzed.|||percentage of participants|||Number
1449862|NCT00853151|Secondary|Percentage of Participants With 2-Fold Elevation of Lipase and/or Amylase at Any Timepoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline amylase.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
1449863|NCT00853151|Secondary|Change From Baseline in Amylase at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline amylase value.|||units/liter (U/L)||Standard Error|Least Squares Mean
1449864|NCT00853151|Secondary|Change From Baseline in Lipase at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline serum lipase. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||units per liter (U/L)||Standard Error|Least Squares Mean
1449865|NCT00853151|Secondary|Change From Baseline in 7-Point Profile, Self-Monitored Blood Glucose (SMBG) at 4-Week and 6-Month Endpoints|7-point average=average of mean value of all time points for visit (premorning meal, 2-hours postmorning meal, premidday meal, 2-hours postmidday meal, preevening meal, 2-hours postevening meal, bedtime). Values represent mean of values collected same time on 3 separate days within week prior to visit. Values from repeated measures included fixed categorical effects: treatment, baseline therapy strata, visit, treatment-by-visit, continuous fixed covariate baseline <7-point average glucose value or time point presented. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value for the variable being analyzed.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1449937|NCT00852995|Secondary|Percentage of Participants With Complete Wound Closure at Each Visit|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test|||percentage of participants|||Number
1449866|NCT00853151|Secondary|7-point Profile, Self-Monitored Blood Glucose (SMBG) Values|The 7-point average is the average of the mean value of all time points for the visit. Time points included pre-morning meal, 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and bedtime.|Baseline (Week -1), 4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
1449867|NCT00853151|Secondary|Change From Baseline in Waist Circumference at 6-Month Endpoint|Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||centimeters (cm)||Standard Deviation|Mean
1449868|NCT00853151|Secondary|Visual Analog Scale (VAS) for Nausea|The Visual Analog Scale (VAS) is a continuous measure for degree of nausea and/or gastrointestinal discomfort. Each of these scales is 100 millimeters (mm) in length with 0 meaning no nausea at all and 100 meaning extreme nausea. Participants record self-assessment of how much nausea they have had, from 0 to 100, during the time interval indicated.|4 weeks, 6 months|Each visit includes participants who received at least 1 dose of TT223 or its placebo who had both a baseline value and a value at that visit.|||units on a scale||Standard Deviation|Mean
1449869|NCT00853151|Secondary|Pharmacokinetics (PKs) of LY2428757, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug. LY2428757 concentrations were collected at only a single timepoint; therefore, pharmacokinetic (PK) parameters could not be modeled from the data. Analysis was not done due to insufficient time points being collected.|0 (pre-dose)|Analyses were not conducted due to insufficient time points being collected; zero participants were analyzed.|||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
1449870|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|Apparent volume of distribution during the terminal phase after extra-vascular administration (Vz/F) is the apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-state after extra-vascular administration (Vss/F) is the apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1449871|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1449872|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Area Under Concentration Versus Time From Zero to Infinity (AUC[0-infinity])|Area under concentration versus time curve from zero to infinity (AUC[0-infinity]). Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
1449873|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Half Life (t1/2)|Half-life (t1/2) is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Geometric Coefficient of Variation|Geometric Mean
1449874|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Full Range|Geometric Mean
1449875|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, 3-Week Time Point - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
1449876|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Volume of Distribution During the Terminal Phase After Extra-Vascular Administration (Vz/F), Apparent Volume of Distribution at Steady-State After Extra-Vascular Administration (Vss/F)|volume of distribution during the terminal phase after extra-vascular administration (Vz/F): Apparent volume that contains drug after absorption is complete and drug is no longer being given. Apparent volume of distribution at steady-State after extra-vascular administration (Vss/F): Apparent volume that contains drug when drug is being given continuously.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1449877|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Apparent Total Body Clearance of Drug Calculated After Extra-Vascular Administration (CL/F)|Apparent total body clearance of drug calculated after extra-Vascular administration (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time, adjusted for how much drug goes into the body fluid.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1449878|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Area Under the Curve (AUC)(0-infinity)|Area under the curve (AUC)(0-infinity) = area under concentration versus time from zero to infinity. Area under the curve (AUC) is a measure of the total exposure to a drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms*hour/milliliter (ng*hr/ml)||Geometric Coefficient of Variation|Geometric Mean
1449879|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Half-Life (t1/2) Associated With the Terminal Rate Constant (λz) in Non-Compartmental Analysis|Half-life is the time it takes for the concentration of drug in plasma to decline by 50%.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Geometric Coefficient of Variation|Geometric Mean
1449880|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration (Cmax) is the maximum observed concentration of drug.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||nanograms per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
1449881|NCT00853151|Secondary|Pharmacokinetics (PKs) of TT223, First Dose - Time of Maximum Observed Drug Concentration (Tmax)|Time of maximum observed drug concentration (Tmax) is the time at which the maximum observed concentration (Cmax) occurs.|0 (pre-dose), 0.33, 0.5, 1, 2, 3, 4, 6 hours|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||hours||Full Range|Geometric Mean
1449882|NCT00853151|Secondary|Number of Participants With Antibodies to TT223|Participants who were positive for antibodies for TT223.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||participants|||Number
1449883|NCT00853151|Secondary|Number of Participants With Antibodies to LY2428757|Participants who were positive for antibodies to LY2428757.|Baseline (Week -1) through 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline value.|||participants|||Number
1449884|NCT00853151|Secondary|Mean Change From Baseline in Weight at Week 0, Week 4, and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline weight. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline weight value.|||kilograms (kg)||Standard Error|Least Squares Mean
1449885|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) Adjusted for Baseline HbA1c, C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance, Duration of Diabetes, and Weight at 3-Week, 4-Week, 2-Month, 3.5-Month, 5-Month, and 6-Month Endpoints|The subgroup analyses for fasting blood glucose (FBG) (adjusted for baseline glycosylated hemoglobin [HbA1c]), C-peptide level, homeostasis model assessment of insulin resistance (HOMA), duration of diabetes, and weight) were not performed due to the lack of statistically significant findings in the subgroup analysis for the glycosylated hemoglobin (HbA1c) analyses. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 4 weeks, 2 months, 3.5 months, 5 months, 6 months||||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1449886|NCT00853151|Secondary|Change From Baseline in MMTT Response (Postprandial Glucose, Glucose AUC, Insulin/c-Peptide Secretory Response, HOMA, GLP-1, Glucagon) Adjusted for Baseline HbA1c, C-Peptide Level, HOMA, Duration of Diabetes, Weight at Week 0, 3, Month 3.5, 6 Endpoints|Subgroup analyses for mixed meal tolerance test (MMTT) response (adjusted for baseline glycosylated hemoglobin (HbA1c), C-peptide level, Homeostasis Model Assessment of Insulin Resistance (HOMA), duration of diabetes, weight) not performed due to lack of statistically significant findings in subgroup analysis for HbA1c analyses. HOMA was not done for mixed meal tolerance test (MMTT) because it is not calculated from the mixed meal tolerance test (MMTT). It is reported separately as a secondary outcome measure. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), Week 0, 3 weeks, 3.5 months, 6 months|Because the subgroup analyses for MMTT response were not conducted due to the lack of statistically significant findings in the subgroup analysis for the HbA1c analyses, zero participants were analyzed.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1449887|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) Adjusted for Baseline Glycosylated Hemoglobin (HbA1c), C-Peptide Level, Homeostasis Model Assessment of Insulin Resistance (HOMA), Duration of Diabetes, and Body Mass Index (BMI) at 6-Month Endpoint|HbA1c adjusted: baseline HbA1c (<8%,≥8%); C-peptide level (normal, elevated); HOMA (<baseline median,≥baseline median); duration diabetes (<3,3-10,>10 years); BMI (<30,≥30). BMI estimates body fat based on weight/height squared. HOMA: index of function of cells that make insulin/insulin resistance. Indices derived from fasting glucose and insulin concentrations. LS means adjusted for treatment, baseline therapy, visit, treatment-by-visit, subgroup, subgroup-by-treatment, subgroup-by-visit, subgroup-by-treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline value.|||percent glucosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
1449895|NCT00853151|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 4-Week Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.|||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
1449888|NCT00853151|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 4-Week and 6-Month Endpoints|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline fasting blood glucose (FBG). Fasting blood glucose (FBG) is the mixed meal tolerance test (MMTT) glucose assessment at time point 0, where available, otherwise it is the assessment taken from the chemistry panel. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 4 weeks, 6 months|Intent-to-treat (ITT): All participants who received at least 1 dose of TT223 or its placebo with a baseline and at least 1 post-baseline fasting blood glucose (FBG) value.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1449889|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Post-Prandial Glucose at 3-Week and 6-Month Endpoints|Standardized MMTT to assess changes in function of cells that make insulin (pancreatic beta cells). Glucose measured at 2-hour timepoint during MMTT reflects glucose values in response to meal. Change in postprandial glucose calculated based on difference of 2-hour postprandial glucose at endpoint compared to baseline. Larger changes from baseline represent a greater postprandial glucose compared to 2-hour timepoint prior to treatment. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit and time point being assessed.|||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
1449890|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon-like Peptide-1 (GLP-1) Area Under the Cure (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under plasma glucagon-like peptide-1 (GLP-1) concentration versus time curve calculated using linear-trapezoidal method. Area under the curve (AUC) for glucagon-like peptide-1 (GLP-1) represents the AUC of GLP-1 values when plotted over time. Larger AUC values represent a greater average GLP-1 value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.|||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
1449891|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucagon Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed meal tolerance test (MMTT) to assess changes in hormones in response to meal. Area under the plasma glucagon concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucagon represents the AUC of glucagon values when are plotted over time. Larger area under the curve (AUC) values represent a greater average glucagon value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a value at Week -1 and a value at that visit.|||picomoles/liter (pmmol/L)||Standard Error|Least Squares Mean
1449892|NCT00853151|Secondary|Change From Baseline in Mixed Meal Tolerance Test (MMTT) Response - Ratio of Insulin Area Under the Curve (AUC)/Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Mixed meal tolerance test (MMTT) to assess changes in function of cells making insulin. AUCinsulin/AUCglucose ratio: index of insulin secretion. Larger values reflect greater secretion adjusted for glucose in response to meal. Area under insulin concentration versus time curve and area under plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for insulin and glucose represents AUC of values plotted over time. LS means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat population (ITT): All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline AUC insulin/AUC glucose value. Reporting is on the 131 participants who received either TT223 or its placebo and reflects data only from the treatment and follow-up phases of the study.|||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
1449893|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - C-Peptide Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents area under the curve (AUC) of C-peptide values when plotted over time. Larger area under the curve (AUC) values represent a greater average C-peptide value over time in response to a meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit interaction. Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline C-peptide area under the curve (AUC) value.|||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
1449894|NCT00853151|Secondary|Change From Baseline in Mixed-Meal Tolerance Test (MMTT) Response - Glucose Area Under the Curve (AUC) at 3-Week and 6-Month Endpoints|Standardized mixed-meal tolerance test (MMTT) used to assess changes in function of cells that make insulin (pancreatic beta cell function). Area under the plasma glucose concentration versus time curve calculated using linear-trapezoidal method. AUC for glucose represents area under curve of values when plotted over time. Larger area under the curve values represent greater average glucose value over time in response to meal. Least squares (LS) means adjusted for baseline, treatment, visit, treatment-by-visit. Change from baseline=absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 3 weeks, 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline value and at least 1 post-baseline glucose area under the curve (AUC) value.|||millimoles/liter*hour (mmol/L*hr)||Standard Error|Least Squares Mean
1450100|NCT00851721|Secondary|Abnormal Prothrombin Fragment F 1.2 Assay Results|The normal reference range of values for prothrombin fragment F 1.2 is 69-229 pmol/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||pmol/L||Inter-Quartile Range|Median
1449896|NCT00853151|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 6-Month Endpoint|Values obtained from repeated measures analysis, which included the fixed categorical effects of treatment, baseline therapy strata (metformin versus diet and exercise [D&E]), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline glycosylated hemoglobin (HbA1c). Change from baseline means the absolute change from baseline (endpoint-baseline).|Baseline (Week -1), 6 months|Intent-to-treat (ITT) population: All participants who received at least 1 dose of TT223 or its placebo with both a baseline and at least 1 post-baseline glycosylated hemoglobin (HbA1c) value.|||percent glycosylated hemoglobin (HbA1c)||Standard Error|Least Squares Mean
1449897|NCT00853112|Secondary|Plasma Concentration of PF-00489791 and Sildenafil||1, 2, 3, 4, 5, 6, 8 hours post-dose on Day 1, follow up (Day 3 to 5)|Data was not reported for this outcome measure because the study was terminated and as per change in planned analysis, the pharmacokinetic parameters were not to be summarized.||||||
1449898|NCT00853112|Secondary|Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose|Arterial blood samples for PaO2 and PaCO2 collected via an arterial line were assessed. PaO2 is the measure of oxygen level in the arterial blood and PaCO2 is the measure of carbon dioxide level in the arterial blood.|Baseline; 1, 4 hours post-dose on Day 1|Safety analysis set included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||mmHg||Standard Deviation|Mean
1449899|NCT00853112|Secondary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Values|Criteria for clinically significant changes (changes of potential clinical concern) in ECG parameters: increase from baseline of >=30 to <60 milliseconds (msec) or >=60 msec in corrected QT interval (QTc), QT interval corrected using Fridericia’s correction (QTcF) and QT interval corrected using Bazett’s correction (QTcB); Increase from baseline of >= 25% (when baseline was >200 msec) or increase from baseline of >=50% (when baseline was <=200 msec) in PR interval; and Increase from baseline of >= 25% (when baseline was >100 msec) or increase from baseline of >=50% (when baseline was <=100 msec) in QRS interval. Number of participants with any clinically significant change in ECG values were reported.|Baseline up-to follow up (Day 3 to 5)|Safety analysis set included all randomized participants who received study medication.|||Participants|||Count of Participants
1449900|NCT00853112|Secondary|Number of Participants With Clinically Significant Laboratory Values|Criteria for clinically significant laboratory values:hemoglobin, hematocrit and red blood cells(less than[<]0.8*lower limit of normal[LLN]); leucocytes (<0.6*LLN/greater than[>]1.5*upper limit of normal[ULN]);platelets (<0.5*LLN></0>1.75* ULN);neutrophils, lymphocytes(<0.8*LLN></0>1.2* ULN); eosinophils, basophils, monocytes (>1.2*ULN);bilirubin (>1.5*ULN);aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(>3*ULN);creatinine, blood urea nitrogen (>1.3*ULN);glucose(<0.6*LLN></0>1.5* ULN); uric acid(>1.2*ULN);sodium(<0.95*LLN></0>1.05*ULN); potassium, chloride, calcium(<0.9*LLN></0>1.1* ULN); albumin, total protein(<0.8></0>1.2* ULN); creatine kinase(>2.0*ULN);urine red blood cells(RBCs), urine white blood cells(WBCs)(>=6 per high-powered field);qualitative urine glucose, urine ketones, urine protein, urine blood/hemoglobin(>=1); urine bacteria(>20 per high-powered field); pregnancy test, urine protein, quantitative random serum pregnancy test (>=1).|Baseline up-to follow up (Day 3 to 5)|Safety analysis set included all randomized participants who received study medication.|||Participants|||Count of Participants
1449901|NCT00853112|Secondary|Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in HR were reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication.|||beats per minute (bpm)||Standard Deviation|Mean
1449902|NCT00853112|Secondary|Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in PVR and SVR were reported. PVR was calculated by: PVR (Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements).|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.|||Wood units||Standard Deviation|Mean
1449903|NCT00853112|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including PCWP, SAP, sSAP and dSAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements (except PCWP for which 1 measurement is sufficient) were performed as triplicate measurements and average was used.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.|||mmHg||Standard Deviation|Mean
1449904|NCT00853112|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose|Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including mPAP, sPAP, dPAP and RAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements were performed as triplicate measurements and average was used.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1449905|NCT00853112|Secondary|Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose|CI was calculated as: CI (liters per minute per square meter [L/min/m^2]) = CO (taken as the average of the triplicate measurements) divided by BSA. BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||L/min/m^2||Standard Deviation|Mean
1449906|NCT00853112|Secondary|Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose|SVRI is the product of SVR and BSA. SVR equals to (mean SAP subtracted by RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) equals to 0.007184 times height (cm)^0.725 times weight (kilogram) ^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in SVRI was reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
1449907|NCT00853112|Secondary|Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose|PVRI was calculated as: PVR multiplied by BSA. PVR = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = 0.007184 times height (cm)^0.725 times weight (kilogram)^0.425. Wood unit equals to 79.9 dyne*second/cm^5. Hourly changes from baseline in PVRI was reported.|Baseline, 1, 2, 3, 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
1449908|NCT00853112|Secondary|Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose|SVRI was calculated as: SVRI (Wood units*m^2) = SVR multiplied by BSA. SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in SVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
1449909|NCT00853112|Secondary|Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose|PVRI was calculated as: PVRI (in Wood units*m^2) = PVR multiplied by BSA. PVR (in Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVRI was calculated as: SVRI (Wood units*m^2) = systemic vascular resistance (SVR) multiplied by BSA. SVR (Wood units) = (mean systemic arterial pressure [mean SAP] minus right atrial pressure [RAP]) divided by CO (taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in cm)^0.725 multiplied by (weight in kg)^0.425. PVRI and SVRI values were converted to dyne*s*m^2/cm^5 from Woods units by multiplying by a factor of 79.9. For each participant the greatest reduction (GR) from baseline in PVRI and SVRI over 4-hour interval was defined as the maximum reduction (greatest decrease or smallest increase) observed at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
1449910|NCT00853112|Primary|Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose|PVRI was calculated as: PVRI (in Wood units*meter^2 [m^2]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure [mean PAP] minus pulmonary capillary wedge pressure [PCWP]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m^2) = (0.007184) multiplied by (height in centimeters [cm])^0.725 multiplied by (weight in kilograms [kg])^0.425. PVRI values were converted to dyne*second (s)*m^2/centimeter (cm)^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.|Baseline, up to 4 hours post-dose on Day 1|Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.|||(dyne*s*m^2)/cm^5||Standard Deviation|Mean
1449911|NCT00853099|Secondary|Number of Participants With Adverse Events During the Adalimumab Treatment Period|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|221 weeks|The safety analysis set.|||participants|||Number
1449912|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 52|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|52 weeks|The safety analysis set.|||participants|||Number
1449935|NCT00852995|Secondary|Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks – the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.|||Days to Closure||95% Confidence Interval|Median
1449913|NCT00853099|Secondary|Number of Participants With Adverse Events up to Week 8|"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.~A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.~For more details on adverse events please see the Adverse Event section below."|8 weeks|The Safety Analysis Set includes all participants who received at least one dose of study medication.|||participants|||Number
1449914|NCT00853099|Secondary|Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders|An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
1449915|NCT00853099|Secondary|Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)|"Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale:~0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
1449916|NCT00853099|Secondary|Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)|"The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows:~0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
1449917|NCT00853099|Secondary|Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)|"Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale:~0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
1449918|NCT00853099|Secondary|Percentage of Participants With Mucosal Healing|"Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52.~The endoscopy subscore ranges from zero to three as follows:~0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
1449919|NCT00853099|Secondary|Percentage of Participants With a Clinical Response|"A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1.~The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore, based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore, based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Baseline and Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
1449920|NCT00853099|Secondary|Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scores from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Weeks 8, 32, and 52|Full analysis set, non-responder imputation was used.|||percentage of participants|||Number
1449936|NCT00852995|Secondary|Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm – 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.|Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||units on a scale||Standard Deviation|Mean
1449921|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 52 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 52|Full analysis set. Non-responder imputation (NRI) was used, where all missing remission values and values after the start of rescue treatment were considered as non-remission.|||percentage of participants|||Number
1449922|NCT00853099|Primary|Percentage of Participants With Clinical Remission at 8 Weeks|"Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:~Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);~Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);~Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);~Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).~The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease."|Week 8|The full analysis set includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication. Non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission.|||percentage of participants|||Number
1449923|NCT00853073|Secondary|Number of Participants With Surgical Success|Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.|6 months||||Participants|||Count of Participants
1449924|NCT00853073|Primary|Intraocular Pressure (IOP)|mmHg (millimeters of mercury)|6 months||||mmHg (millimeters of mercury)||95% Confidence Interval|Mean
1449925|NCT00853021|Other Pre-specified|T-helper Cells (Type 1,2)|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
1449926|NCT00853021|Other Pre-specified|CD25+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
1449927|NCT00853021|Other Pre-specified|CD4+ Treg Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
1449928|NCT00853021|Other Pre-specified|IL-8 Levels|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
1449929|NCT00853021|Other Pre-specified|CD303+ Plasmacytoid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), beginning and end of cycle 1 (day 1, 57)|||||||
1449930|NCT00853021|Other Pre-specified|Peripheral Blood CD1c+ Myeloid Dendritic Cells|Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.|Baseline (day -14), Beginning and end of cycle 1 (day 1, 57)|||||||
1449931|NCT00853021|Secondary|Percentage of Patients With Neutropenia|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of neutropenia|From start of treatment to 30 days after treatment||||percentage of participants|||Number
1449932|NCT00853021|Secondary|Percentage of Patients With Constitutional Adverse Events|Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of fatigue and fever/chills|From start of treatment to 30 days after treatment||||percentage of patients|||Number
1449933|NCT00853021|Secondary|Objective Response Rate (Complete and Partial Response)|To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.|4 weeks after treatment||||percentage of participants|||Number
1449934|NCT00853021|Primary|Progression Free Survival|Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.|From baseline (day -14) to disease progression (reported at 2 years)||||months||95% Confidence Interval|Median
1450101|NCT00851721|Secondary|Abnormal Fibrin Degradation Products (FDP) Assay Results|The normal reference range of values for FDP is 0-5 ug/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||ug/mL||Inter-Quartile Range|Median
1449938|NCT00852995|Secondary|Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13|The area of each subject’s target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.|Over the 12 week treatment period or until the wound closed, which ever occurred first.|The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo.|||Responders|||Number
1449939|NCT00852995|Secondary|Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P < 0.05.|||Percent change||Standard Error|Least Squares Mean
1449940|NCT00852995|Secondary|Kaplan-Meier Probability of Non-Closure|This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.|14 weeks – the final visit for one subject was delayed by two weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P < 0.05.|||Probability of Non-Closure|||Number
1449941|NCT00852995|Primary|The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.|For each treatment group the area of each subject’s target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P < 0.05.|||percent change||Standard Deviation|Mean
1449942|NCT00852969|Secondary|Change in HDL-C From Baseline to 14 Weeks||14 weeks since baseline||||mg/dl||95% Confidence Interval|Mean
1449943|NCT00852969|Primary|Change in the Flow Mediated Dilation From Baseline|Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks|14 weeks since baseline||||absolute percent change||95% Confidence Interval|Mean
1449944|NCT00852930|Primary|Whole Arm Volume Difference|Whole arm measurement to determine volume.|Baseline and on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.||||Whole Arm Volume % Difference||Inter-Quartile Range|Median
1449945|NCT00852930|Secondary|Quality of Life|The Functional Assessment of Chronic Illness Therapy that measure quality of life -total score. Range of scores could be 0 to 148. Higher score represents higher quality of life.|Self-report on last day of treatment with average number of treatments being 9 conducted over a median of up to 4 weeks.||||total score||Inter-Quartile Range|Median
1449946|NCT00852930|Secondary|Symptoms|Yes/no response to a symptom listed on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A) self-report form.|Self report on last day of treatment with average treatments being 9 conducted over a median of up to 4 weeks.|Total number of reported symptoms. Range of symptoms reported could be 0 to 36. Greater number of symptoms represents worse outcome.|||symptoms||Inter-Quartile Range|Median
1449947|NCT00852930|Primary|LDex Change-|Bioimpedance measured by units of LDex. As extracellular fluid accumulates (i.e. lymphedema develops) the LDex value increases.|Bioimpedance at baseline and end of treatment with the average number of treaments being 9 conducted over a median of up to 4 weeks.|LDex units.|||LDex||Inter-Quartile Range|Median
1449948|NCT00852917|Secondary|Dropout Rate|Reasons for withdrawal from the trial were collected|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.|||percentage of participants|||Number
1449949|NCT00852917|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference in WOMAC Physical||Standard Deviation|Mean
1449950|NCT00852917|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient’s overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||participants|||Number
1449951|NCT00852917|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||mm||Standard Deviation|Mean
1449981|NCT00852631|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.~Minimum value considered better is score decreased from baseline at least 30%."|From Day 1 (baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.|||Scores on a scale||Standard Deviation|Mean
1449952|NCT00852917|Secondary|Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no difficulty (0mm) to extreme difficulty (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||Percentage difference in WOMAC Physical||Standard Deviation|Mean
1449953|NCT00852917|Secondary|Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||Percentage difference in WOMAC Pain||Standard Deviation|Mean
1449954|NCT00852917|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions.|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference in WOMAC Pain||Standard Deviation|Mean
1449955|NCT00852917|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)|||participants|||Number
1449956|NCT00852761|Secondary|Dermatology Life Quality Index (DLQI) Categories|Number of participants who indicated one of the following for total DLQI: 0-1 No effect on the patient's life; 2-5 Small effect on the patient's life; 6-10 Moderate effect on the patient's life; 11-20 Very large effect on the patient's life.|Days 3, 8, 15||||participants|||Number
1449957|NCT00852761|Secondary|Total Dermatology Life Quality Index (DLQI) Score|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for all questions. Score range from 0 to 30. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
1449958|NCT00852761|Secondary|Dermatology Quality of Life - Treatment|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for question 10. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
1449959|NCT00852761|Secondary|Dermatology Quality of Life - Personal Relationships|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 8 and 9. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
1449960|NCT00852761|Secondary|Dermatology Quality of Life - Work and School|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 7. Score range from 0 to 3. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
1449961|NCT00852761|Secondary|Dermatology Quality of Life - Leisure|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 5 and 6. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
1449962|NCT00852761|Secondary|Dermatology Quality of Life - Daily Activities|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 3 and 4. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
1449963|NCT00852761|Secondary|Dermatology Quality of Life - Symptoms and Feelings|"Dermatology Quality of Life (DLQI) measures quality of life for people with skin conditions.~Sum of scores for questions 1 and 2. Score range from 0 to 6. A higher score denotes a more impaired quality of life"|Baseline, Days 3, 8, 15|ITT (Note: some subjects did not complete the survey at all timepoints; however, all data available was analyzed.)|||units on a scale||Standard Deviation|Mean
1449964|NCT00852761|Secondary|Median Change in Psoriasis Grading Scale|Median improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline, Days 3, 8, 15|ITT|||unites on a scale||Inter-Quartile Range|Median
1450102|NCT00851721|Secondary|Abnormal Fibrinogen Assay Results|The normal reference range of values for fibrinogen is 200-400 mg/dL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||mg/dL||Inter-Quartile Range|Median
1449965|NCT00852761|Secondary|At Least a 3 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum three grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449966|NCT00852761|Secondary|At Least a 2 Grade Improvement in Subject's Global Assessment|Number of participants who achieve treatment success (minimum two grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject's Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449967|NCT00852761|Secondary|At Least 1 Grade Improvement in Subject’s Global Assessment|Number of participants who achieve treatment success (minimum one grade improvement or more) in their elbow and/or knee target lesion as defined by the Subject’s Global Assessment. 0 = My skin is completely clear, except for residual hyperpigmentation. 1 = My psoriasis is almost clear; patchy fine scaling may be present. 2 = My psoriasis is mild, with a small amount of psoriasis. 3 = My psoriasis is moderate, between slight and definitely noticeable. 4 = My psoriasis is very noticeable. 5 = My psoriasis is severe with severe redness, thick scaling, plaques.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449968|NCT00852761|Secondary|At Least a 3 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 3 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449969|NCT00852761|Secondary|At Least a 2 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 2 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449970|NCT00852761|Secondary|At Least 1 Grade Improvement in the Psoriasis Global Assessment|Number of participants who acheive at least a 1 grade improvement in the Psoriasis Global Assessment. 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe.|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449971|NCT00852761|Secondary|At Least a 3 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum of three grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449972|NCT00852761|Secondary|At Least a 2 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum two grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3, 8, 15|Intent to treat (ITT)|||participants|||Number
1449973|NCT00852761|Secondary|At Least 1 Grade Improvement Psoriasis Grading Scale|"Number of participants who achieve a minimum one grade improvement or more in their elbow and/or knee target lesion as defined by the Psoriasis Grading Scale for Target Lesion.~The scale is the same as used for the primary outcome (0 through 5)."|Baseline, days 3 and 8|Intent to treat (ITT)|||participants|||Number
1449974|NCT00852761|Primary|At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)|Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.|Baseline to day 15|ITT|||participants|||Number
1449975|NCT00852644|Secondary|Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival|Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging|before treatment and at 1, 3, 6, and 12 months after treatment|Data were not collected and the outcome measure was not analyzed||||||
1449976|NCT00852644|Primary|Maximum Tolerated Dose - More Than 3 Centimeter Cohort.|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.|6 weeks|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.||||dose||
1449977|NCT00852644|Primary|Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort|The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort|6 weeks||||Participants|||Count of Participants
1449978|NCT00852644|Primary|Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.|6 weeks|The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.||||dose||
1449979|NCT00852644|Primary|Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort|Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort|6 weeks||||Participants|||Count of Participants
1449980|NCT00852631|Secondary|Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|Day 14|The number of patient is different, because some of them withdraw/terminate during the study.|||Scores on a scale||Standard Deviation|Mean
1454517|NCT00818337|Primary|Number of Women Aspirin Resistant|Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation.|Baseline||||participants|||Number
1449982|NCT00852631|Secondary|Change in Clinical Global Impression - Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.|From Day 1 (Baseline) to Day 42|The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.|||Scores on a scale||Standard Deviation|Mean
1449983|NCT00852592|Secondary|Global Assessment of Functioning (GAF)|The GAF is used to assess global psychosocial functioning. Scores range from 0-100 with higher values representing higher functioning and better outcome.|6-weeks||||units on a scale||Standard Deviation|Mean
1449984|NCT00852592|Primary|SIGH-ADS Depression Score|The Structured Interview Guide for the Hamilton Depression Rating Scale-HRS-D with Atypical Depression Supplement (SIGH-ADS) provides a benchmark for depression severity; SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
1449985|NCT00852540|Secondary|Mean Wound Size at Visits 1, 2, 3, 4, and 5|Lesion sized was measured in centimeters squared at Visits 1, 2, 3, 4, and 5.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing data were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||centimeters squared (cm^2)||Standard Deviation|Mean
1449986|NCT00852540|Secondary|Mean Scores on the Skin Infection Rating Scale at Visits 1, 2, 3, 4, and 5|The investigator evaluated skin infections by grading the infected lesion for exudate (a fluid that leaks out of blood vessels into surrounding tissue)/pus, crusting, erythema (redness of the skin)/ inflammation (E/I), tissue warmth, tissue edema (swelling), itching, and pain, according to the Skin Infection Rating Scale. All parameters were graded on a scale of 0 (absent) to 6 (severe). The total score is calculated by summing the individual scores from the 7 parameters; the total score ranges from 0 to 42.|Visits 1 (Day 1), 2 (Day 3-4), 3 (Day 7-9), 4 (Day 12-14), and 5 (Day 17-19)|ITTC Population. Only participants with non-missing Skin Infection Rating Scale scores were included in this analysis. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||scores on a scale||Standard Deviation|Mean
1449987|NCT00852540|Secondary|Number of Participants With Therapeutic Response at Follow-up|"Therapeutic response is defined as the combined clinical and microbiological response. Therapeutic response iss a measure of the overall efficacy response, and a therapeutic success refers to participants who had been deemed both a “clinical success” and a “microbiological success. All other combinations (other than “clinical success” + “microbiological success”) were deemed failures for therapeutic response."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|ITTB Population|||participants|||Number
1449988|NCT00852540|Secondary|Number of Baseline Pathogens With the Indicated Microbiological Outcome at the End of Therapy|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTB Population|||pathogens|||Number
1449989|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTC Population. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||participants|||Number
1449990|NCT00852540|Secondary|Number of Participants With the Indicated Microbiological Outcome at the End of Therapy Who Had MRSA as a Baseline (BL) Pathogen|"Eradication is the elimination of BL pathogens. Presumed eradication and presumed improvement are clinical outcomes of success or improvement, respectively, such that no culture was obtained due to lack of culturable material, secondary to adequate clinical response, and is documented in the electronic Case Report Form. Persistence is defined as BL pathogens still being present. Presumed persistence is defined as a participant that is a clinical failure with no obtained culture. Unable to determine was used if no determination of BL pathogen microbiological response could be made."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population|||participants|||Number
1449991|NCT00852540|Secondary|Number of Participants With the Indicated Clinical Outcome at the End of Therapy Who Had MRSA as a Baseline Pathogen|"Clinical improvement is defined as improvement of signs/symptoms of infection recorded at baseline (BL) to such an extent that no further antimicrobial therapy is necessary. Clinical failure (CF) is defined as insufficient improvement/deterioration of signs/symptoms of the infection recorded at BL, such that additional antibiotic therapy is required. Unable to determine (UTD) is defined as refusal to consent to a clinical examination, lost to follow-up. Participants who are CF/Unable to Determine at end of therapy are considered such at follow-up as well."|2-4 days post-therapy; Day 7-9 for retapamulin and Day 12-14 for linezolid|ITTMRSA Population|||participants|||Number
1450046|NCT00851799|Secondary|Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96|Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
1449992|NCT00852540|Secondary|Number of Participants Who Achieved Microbiological Response (MR) at Follow-up (FU) Who Had a Baseline Pathogen (BP)|MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was “clinical success (CS)/improvement,” the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a “CS” such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a “CS.”|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Bacteriology (ITTB) Population: all randomized participants who took at least one dose of study medication and who had a pathogen isolated at baseline.|||participants|||Number
1449993|NCT00852540|Secondary|Number of Participants With Clinical Response at Follow-up|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat Clinical (ITTC) Population: all randomized participants (par.) who took at least one dose of study medication. One par. was randomized to retapamulin but received linezolid. This par. is summarized in the linezolid group for all baseline and safety tables, but is summarized in the retapamulin group for all efficacy tables.|||participants|||Number
1449994|NCT00852540|Secondary|Number of Participants Achieving Microbiological Response (MR) at Follow-up (FU) Who Had MRSA as a Baseline Pathogen (BP)|MR was defined as microbiological success if, (1) for participants (par.) whose clinical outcome at end of therapy (EOT) was “clinical success (CS)/improvement,” the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and absent at FU, or the BP was eradicated/presumed to be eradicated at EOT, or the BP was present at EOT and par. was a “CS” such that no culture was obtained due to lack of culturable material secondary to adequate clinical response; or (2) a pathogen not previously identified at baseline was isolated at FU in a par. identified at FU as a “CS.”|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.|||participants|||Number
1449995|NCT00852540|Primary|Number of Participants Achieving Clinical Response at Follow-up Who Had Methicillin-resistant Staphlococcus Aureus (MRSA) as a Baseline Pathogen|"Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of 0. The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe)."|7-9 days post-therapy; Day 12-14 for retapamulin and Day 17-19 for linezolid|Intent-to-Treat MRSA (ITTMRSA) Population: all randomized participants who took at least one dose of study medication and who had an MRSA isolated at baseline.|||participants|||Number
1449996|NCT00852527|Primary|Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)|Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.|All OEF/OIF Veterans to receive TCRS upon enrollment in VA|Although 456 participants were consented and enrolled in the study, data for 13 participants had missing assessment data and another 5 were determined to have moderate TBI resulting in 438 cases for the analysis.|||Percentage of participants||95% Confidence Interval|Number
1449997|NCT00852475|Secondary|Endothelium-dependent FMD Assessed by the Brachial Artery Reactivity Test (BART) at Rest .|Ultrasonographic imaging of the brachial artery (BART) was used to assess endothelium-dependent flow-mediated vasodilation (FMD) in participants at rest. To do this,the blood pressure cuff is inflated to 200 mm Hg and kept inflated for 5 minutes. On immediate release of the cuff, the brachial artery was imaged within 1 minute after cuff release.|6 months from Baseline||||percentage of change from baseline||Standard Error|Mean
1449998|NCT00852475|Primary|Weight Changes in Veterans With MetS.||6 months from Baseline||||kg||Standard Error|Mean
1449999|NCT00852397|Other Pre-specified|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.|"TIMI minor bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 3 gm/dL fall in hemoglobin or a 9% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).~TIMI minimal bleeding event was defined as a clinically overt bleeding (including bleeding evident on imaging studies) not meeting criteria for TIMI minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
1450000|NCT00852397|Other Pre-specified|Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.|"ISTH-defined CRNM bleeding was defined as an acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.~ISTH defined minor bleeding event was defined as all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM bleeding were classified as minor bleeding."|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
1450103|NCT00851721|Secondary|Abnormal D-Dimer Assay Results|The normal reference range of values for D-dimers is <500 ng/mL.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||ng/mL||Inter-Quartile Range|Median
1450001|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.|Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time]).|From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])|The efficacy analysis set was all randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
1450002|NCT00852397|Secondary|Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.||For 30 days after Week 24 or the discontinuation of study drug|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
1450003|NCT00852397|Secondary|Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.|TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit).|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
1450004|NCT00852397|Secondary|Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.|Major bleeding event was defined as an acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
1450005|NCT00852397|Secondary|Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.|All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
1450006|NCT00852397|Primary|Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring During the Treatment Period.|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Week 0 to Week 24|Bleeding endpoint was included in safety evaluations. The safety analysis set was defined as all treated participants (randomized participants who received at least one dose of study drug).|||Percentage of Participants||95% Confidence Interval|Number
1450007|NCT00852241|Primary|The Primary Objective of This Study is to Determine the Efficacy and Longevity of the Use of Restylane® and Perlane® in Combination for the Rejuvenation of the Infraorbital Hollows and to Measure Patient Satisfaction With This Treatment||1 year|The Principle Investigator left the institution and no data is available.||||||
1450008|NCT00852202|Secondary|Change in Baseline in Clinical Global Impressions–Improvement ( CGI-I )|The patient was rated on a scale from 1 to 7, with 1 indicating the patient was very much improved and 7 indicating that the patient was very much worse.|Baseline to Week 8|of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 53 for 1.5 to 3.0 mg Cariprazine|||Score on Scale||Standard Error|Mean
1450009|NCT00852202|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)|The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity.|Baseline to Week 8|of the 227 included to the safety population, the mixed-effects model for repeated measures (MMRM) of the Intent to Treat study population was 60 for placebo, 64 for 0.25-0.75 mg Cariprazine and 54 for 1.5 to 3.0 mg Cariprazine|||Score on scale||Standard Error|Mean
1450010|NCT00852137|Secondary|Max Composite Local Skin Response (LSR) Score|Max composite Local Skin Response (LSR) score on day 3 only . The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0–24. (One vehicle treated patent had a LSR on day 1 only).|Day 3||||local skin response score||Standard Deviation|Mean
1450011|NCT00852137|Secondary|Patients With Incidence of Pigmentation and Scarring|Patients with Incidence of pigmentation and scarring, and grade of pigmentation and scarring, following study treatment through Day 57|Baseline, Day 2, 3, 8, 15, 29 and 57||||participants|||Number
1450104|NCT00851721|Secondary|Abnormal Activated Partial Thromboplastin Time (aPTT) Assay Results|The normal reference range of values for aPTT is 22.8 – 31 seconds.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||seconds||Inter-Quartile Range|Median
1450012|NCT00852137|Secondary|Number of Patients With Local Skin Responses (LSRs) Above 0 at Any Time Point During the Study.|Number of patients with LSR at any time point during the study above 0. The treatment area was assessed at baseline and at each subsequent study visit for the presence and grade of the following Local Skin Responses (LSRs): erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration using the Local Skin Response Grading Scale (version 5). Each LSR was graded from 0 (best outcome) to 4 (worst outcome). A composite LSR score was calculated as the sum of each individual LSR grade, giving a possible range of 0–24.|baseline and Day 2, 3, 8, 15, 29 and 57||||participants|||Number
1450013|NCT00852137|Secondary|Percentage (%) Change in Actinic Keratosis (AK) Lesions in a 25 cm^2 Area Within the Selected Treatment Area|Percentage (%) change in actinic keratosis (AK) lesions count at Day 57, compared to baseline, in a 25 cm^2 area within the selected treatment area.|Baseline and Day 57||||change from baseline lesion count (%)||Standard Deviation|Mean
1450014|NCT00852137|Secondary|Complete Clearance Rate in a 25 cm^2 Area Within the Selected Treatment Area|Number of participants with complete clearence. Complete clearance rate is defined as no clinically visible actinic keratosis (AK) lesions in a 25 cm^2 area within the selected treatment area at Day 57 compared to baseline|baseline and day 57||||participants|||Number
1450015|NCT00852137|Primary|Area Under the Blood Conc. Versus Time Curve for Time 0–24 Hours (AUC(0-24)) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Area under the blood conc. versus time curve was calculated for time 0–24 hours (AUC(0-24)) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day||||ng/mL x h||Standard Deviation|Mean
1450016|NCT00852137|Primary|Time at Which Cmax is Attained (Tmax) for Ingenol Mebutate, and Its Two Acyl Isomers (PEP015 and PEP025) Levels.|Time at which Cmax is attained (Tmax) for ingenol mebutate, and its two acyl isomers (PEP015 and PEP025) levels measured at 30 min, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2. If a maximum value occured at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day||||hours|||Number
1450017|NCT00852137|Primary|Maximum Observed Concentration (Cmax) for Ingenol Mebutate and Its Two Acyl Isomers (PEP015 and PEP025) Levels|Maximum observed concentration (Cmax) for ingenol mebutate and its two acyl isomers (PEP015 and PEP025) levels over the 24 hour sampling time period based on actual values measured. Blood samples were taken: at 30 minutes, 1, 2, 4, 8, 12 and 24 hours following study medication application on Day 2.|1 day||||ng/mL||Standard Deviation|Mean
1450018|NCT00852124|Primary|Safety of VSL#3 in Adults Asthmatics|Change in FEV in adult asthmatics receiving VSL3# as compared to controls receiving placebo.|3 months|3 people were randomized to placebo arm but no data were analyzed due to early termination of study and small number of patients enrolled.||||||
1450019|NCT00851903|Secondary|Change in Body Weight From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value|The population analyzed was the safety population with both baseline and endpoint values available|||kg||Standard Deviation|Mean
1450020|NCT00851903|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment period (12 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population|||participants|||Number
1450021|NCT00851903|Secondary|Insulin Dose|Daily dose at the face-to-face visits|baseline, week 4, week 8, week 12|mITT population|||unit per kg body weight||Standard Deviation|Mean
1450022|NCT00851903|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|"The population analyzed consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing."|||mg/dL||Standard Deviation|Mean
1450023|NCT00851903|Secondary|Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Change = study endpoint - baseline."|baseline, study endpoint: week 12 or week 8 if value not available at week 12|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure|||mg/dL||Standard Deviation|Mean
1450024|NCT00851903|Secondary|HbA1c: Change From Baseline to Study Endpoint|Change = study endpoint - baseline|baseline, study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure|||percent||Standard Deviation|Mean
1450025|NCT00851903|Primary|HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)||study endpoint: week 12 or earlier in case of premature discontinuation|The population analyzed consisted of the subset of mITT patients who had HbA1c value at study endpoint.|||percentage of participants||95% Confidence Interval|Number
1450026|NCT00851890|Secondary|Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28|Phenotypic resistance to ABT-333 was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the corresponding baseline sample, and the maximal fold change in EC50 from baseline over the Day 5-28 period. The resistance sample drawn before the first dose of ABT-333 on Day 1 was defined as the baseline sample. The number of participants with phenotypic resistance in the post-baseline samples are presented.|Days 1 through 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||participants|||Number
1450058|NCT00851799|Secondary|CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144|The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144.|Study entry, weeks 24, 48, 96 and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.|||cell/mm^3||Inter-Quartile Range|Median
1450027|NCT00851890|Secondary|Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28|Samples from Days 1, 5, 10, 17, 24 and 28 were analyzed for the presence of resistance-associated amino acids using population sequencing and compared to the baseline non-structural viral protein 5B (NS5B) sequence to assess amino acid changes. The amino acid sequence of NS5B before the first dose of ABT-333 on Day 1 was defined as the baseline sequence. The number of participants with variants at resistance-associated amino acid positions in the post-baseline samples are presented.|Days 1, 5, 10, 17, 24 and 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||participants|||Number
1450028|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of detection (LLOD) was defined as a HCV RNA level equal to 10 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).|||percentage of participants|||Number
1450029|NCT00851890|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The lower limit of quantification (LLOQ) was defined as HCV RNA levels ≤ 25 IU/mL. Data are reported as the percentage of participants.|Day 28 or Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA).|||percentage of participants|||Number
1450030|NCT00851890|Secondary|Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. Data are reported as the percentage of participants.|Prior to the first dose on Day 1 and Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||percentage of participants|||Number
1450031|NCT00851890|Secondary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1 and the Day 28 or Final Visit value was the last HCV RNA measurement during the study. Data are reported as the least squares mean change from baseline ± standard error.|Day 28 and Final Visit|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||log10 IU/mL||Standard Error|Least Squares Mean
1450032|NCT00851890|Primary|Number of Participants Having Treatment-emergent Adverse Events (AEs)|"An AE was any untoward medical occurrence that did not have a causal relationship with treatment. An Adverse Drug Reaction (ADR) was any noxious and undesired reaction related to the experimental drug or experiment. A serious adverse event (SAE) was an AE that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in congenital anomaly, was persistent or caused significant disability/incapacity, spontaneous or elective abortion, or required intervention to prevent a serious outcome. AEs were rated for severity as either:~Mild - transient and easily tolerated;~Moderate - caused discomfort and interrupted usual activities;~Severe - caused considerable interference with usual activities, may be incapacitating or life-threatening.~AEs related to direct-acting antiviral agents (DAAs) were assessed as being either probably or possibly related by the investigator."|AEs were collected from the time of study drug administration to 30 days after last dose of study drug (8 Weeks)|Participants received at least 1 dose of study drug.|||participants|||Number
1450033|NCT00851890|Primary|Plasma Concentrations of Ribavirin (RBV)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Standard Deviation|Mean
1450034|NCT00851890|Primary|Serum Concentrations of Pegylated Interferon (pegIFN)|Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation.|Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.|||ng/mL||Standard Deviation|Mean
1450105|NCT00851721|Secondary|The Number of Bleeding Episode (BE) Which Required 1, 2, 3, or ≥4 Infusions to Control Bleeding||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set~- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."|||Bleeding Episodes (BEs)|||Number
1450035|NCT00851890|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) measures the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng*hr/mL||Standard Deviation|Mean
1450036|NCT00851890|Primary|Time to Maximum Plasma Concentration (Tmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||Hours||Standard Deviation|Mean
1450037|NCT00851890|Primary|Maximum Plasma Concentration (Cmax) of ABT-333|Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.|Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2|Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
1450038|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during treatment was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level on Day 28. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 through Day 28|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||log10 IU/mL||Standard Error|Least Squares Mean
1450039|NCT00851890|Primary|Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment|Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during monotherapy was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 3. Data are reported as the least squares mean change from nadir ± standard error.|Prior to the first dose on Day 1 to before first dose on Day 3|Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA.|||log10 IU/mL||Standard Error|Least Squares Mean
1450040|NCT00851877|Secondary|Phase II 2-year Overall Survival|median follow-up 24 months for 34 patients|2 year|12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.|||percentage of participants||95% Confidence Interval|Number
1450041|NCT00851877|Secondary|Phase II 2-year Local Control|Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions|2 year|12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.|||percentage of participants||95% Confidence Interval|Number
1450042|NCT00851877|Primary|Phase II 2-year Progression-free Survival|"Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death."|2 year|12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.|||percentage of participants||95% Confidence Interval|Number
1450043|NCT00851877|Primary|Phase I Maximum Tolerated Dose of Nab-Paclitaxel|Seven participants were assigned nab-paclitaxel in dose of 25mg/m^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m^2.|90 days|12 patients enrolled in the phase I study.|||mg/m^2|||Number
1450044|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
1450045|NCT00851799|Secondary|Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96|Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value).|Study entry, weeks 24 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
1450047|NCT00851799|Secondary|Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96|Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
1450048|NCT00851799|Secondary|Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96|IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
1450049|NCT00851799|Secondary|Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96|hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
1450050|NCT00851799|Secondary|Fold Change in D-dimer From Study Entry to Weeks 48 and 96|D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay.|Study entry, weeks 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||Fold change||Inter-Quartile Range|Median
1450051|NCT00851799|Secondary|Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96|Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||uIU/dL||Inter-Quartile Range|Median
1450052|NCT00851799|Secondary|Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96|Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
1450053|NCT00851799|Secondary|Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96|Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
1450054|NCT00851799|Secondary|Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96|HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
1450055|NCT00851799|Secondary|Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96|Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
1450056|NCT00851799|Secondary|Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96|Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result).|Study entry, weeks 4, 24, 48 and 96|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mg/dL||Inter-Quartile Range|Median
1450057|NCT00851799|Secondary|Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144|Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry).|Study entry to weeks 24, 48, 96, and 144|Intention to treat; all eligible participants with available data were included. Missing data were assumed missing completely at random. Participants were analyzed per original assigned randomized treatment in ACTG A5257.|||cell/mm^3||Inter-Quartile Range|Median
1450059|NCT00851799|Secondary|Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96|Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450060|NCT00851799|Secondary|Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96|Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450061|NCT00851799|Secondary|Percent Change in Lean Mass From Study Entry to Week 96|Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450062|NCT00851799|Secondary|Percent Change in Trunk Fat From Study Entry to Week 96|Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450063|NCT00851799|Secondary|Percent Change in Total Limb Fat From Study Entry to Week 96|Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450064|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96|Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450065|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96|Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450066|NCT00851799|Secondary|Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96|Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100.|Study entry, week 96|Intention to treat; all eligible participants with available data were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257|||percent||Inter-Quartile Range|Median
1450067|NCT00851799|Secondary|Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48|The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.|Study entry, weeks 4, 24 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||mm||Standard Deviation|Mean
1450068|NCT00851799|Secondary|Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, weeks 4 and 48|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||95% Confidence Interval|Mean
1450069|NCT00851799|Primary|Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24|"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter."|Study entry, week 24|Intention to treat; all eligible participants with available data were included. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||percent||Inter-Quartile Range|Median
1450097|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Hepatitis A, Hepatitis B, and Hepatitis C|"Hepatitis A Virus Antibody (HAV Ab)~Hepatitis B Virus Core Antibody (HBcAb)~Hepatitis B Virus Surface Antibody (HBsAb)~Hepatitis B Virus Surface Antigen (HBsAg)~Hepatitis C Virus (HCV)"|12 months ± 14 days|Safety Analysis Set|||participants|||Number
1450070|NCT00851799|Primary|Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)|"Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.~The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors."|Study entry, week 144|Intention to treat; all eligible participants were included in the analysis. Participants were analyzed per original assigned randomized treatment and stratification in ACTG A5257.|||micron/year||95% Confidence Interval|Mean
1450071|NCT00851786|Secondary|Geometric Mean Fold Rise (GMFR) in VZV ELISpot Responses|VZV-specific cellular immune responses in peripheral blood mononuclear cells (PBMC) were tested by ELISpot assay in a subset of participants pooled across CD4 strata. GMFR is the geometric mean of the ratios of Week 6 or Week 12 post-vaccination antibody to the pre-vaccination antibody.|Entry, Week 6, Week 12|Number of participants with ELISpot results available at entry and at the post-entry week (week 6 or week 12, respectively).|||fold rise||90% Confidence Interval|Geometric Mean
1450072|NCT00851786|Secondary|VZV Antibodies as Measured by gpELISA|VZV antibody titer measured by gpELISA after one or two doses of ZOSTAVAX/placebo|Within 6 weeks following one or two doses of ZOSTAVAX|Subjects with both baseline gpELISA result and at least one post vaccination gpELISA result available|||log gpELISA antibody titer||Standard Deviation|Mean
1450073|NCT00851786|Primary|Number of Participants With Composite Safety Endpoint of the Occurrence of Serious Adverse Events (SAEs) or Division of AIDS (DAIDS) Grade 3 and 4 Signs and Symptoms, Excluding SAEs Related to Trauma|Although the study was designed as a randomized trial, it was not powered to detect safety related differences between treatment arms. The safety of ZOSTAVAX was determined by comparing the number of subjects from the active arm who experienced safety endpoint to the number from a pre-specified decision rule, which was calculated based on a similar population and calibrated using the number of safety endpoints observed from the placebo arm. The pre-specified decision rule is that ZOSTAVAX would be considered to have acceptable safety if no more than 18 subjects experience a study-defined composite safety endpoint.|During the 6 week study period after receipt of any dose of ZOSTAVAX|Subjects who received at least one dose of study vaccine/placebo|||participants|||Number
1450074|NCT00851747|Primary|Efficacy of Phosphatidylcholine and Deoxycholate Subcutaneous Injections for Localized Fat Removal.|The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits|1 year|PI left institution and no data is available.||||||
1450075|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Pediatrics <12 Years Old|"General pain was assessed using the children’s VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). Assessments were done at the screening, 6 months, and termination visits.~Scores on the children's VAS scale are presented as:~No Pain~Mild Pain~Moderate pain~Severe pain~Very severe pain~Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account.~Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||participants|||Number
1450076|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL) - General Pain Assessment Using a Visual Analogue Scale (VAS) in Adults and Adolescents ≥12 Years Old|"General pain was assessed using a VAS pain scale at screening, 6 months, and at termination. Unlike the VAS pain assessment for pain of bleeding episodes (Outcome above), this general pain assessment did not take use of analgesics into account. For the pain scale, a higher number indicates worse pain.~The visual analog scale ranges from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). A positive change from baseline indicates improvement.~Change in VAS scores at 6 months and study termination were also compared relative to Baseline/Screening scores (ie, (Baseline/Screening VAS score) - (VAS score at 6 months and study termination)."|Baseline, 6 months and 12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants ≥12 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
1450077|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Child's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - comprised of all participants <16 years old, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
1450098|NCT00851721|Secondary|Abnormal Thrombin-Antithrombin III (TAT) Assay Results|The normal reference range of values for TAT is 1-4.1 ug/L.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||ug/L||Inter-Quartile Range|Median
1450099|NCT00851721|Secondary|Abnormal Prothrombin Time Assay Results|The normal reference range of values for PT is 9.7-12.3 sec.|Screening visit, Month 3, Month 6, Month 9, and Termination visit|Safety Analysis Set Participants with Clinically Significant Laboratory Results|||seconds||Inter-Quartile Range|Median
1455049|NCT00814164|Secondary|A Preliminary Relationship Between Treatment Outcome and Biologic Parameters||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
1450078|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Children and Adolescents < 16 Years Old (Haemo-QoL) - Parent's Evaluation|"The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & School (S&S), Dealing with Hemophilia (Dealing), Family, Feeling, Relationships (R'ships), Treatment, View, Outlook for the Future (Future), Friends, Others, and Support. A Haemo-QoL Total Score (Total) was also calculated. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haemo-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset - for all participants <16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
1450079|NCT00851721|Secondary|Hemophilia-specific Quality of Life Questionnaire for Adults (Haem-A-QoL) ≥ 16 Years Old|"The Haem-A-QoL instrument has been developed and used in Hemophilia A patients. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. The areas covered by this instrument are: Physical Health (PH), Sports & Leisure (S&L), School & Work (W&S), Dealing with Hemophilia (Dealing), Family Planning (FP), Feeling, Relationships (R'ships), Treatment, View, and Outlook for the Future (Future). A Haem-A-QoL Total Score (Total) was also calculated. For the Haem-A-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.~Haem-A-QoL scores at screening, 6 months, and at termination visit were collected. Changes in scores at 6 months and termination were also calculated."|12 months ± 14 days|Health-Related Quality of Life (HRQoL) Intent-to-Treat Analysis Dataset for all participants ≥ 16 years old who were randomized, had any available assessments at any available study visits (baseline, 6-month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
1450080|NCT00851721|Secondary|Health-Related Quality of Life (HRQoL): EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Index Scores|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.~EQ-5D Index scores based on EQ-5D questionnaire were calculated for participants ≥14 years of age, at screening, 6 months, and at termination visit. Changes in scores at 6 months and termination were also calculated.~A relatively higher score represents better quality of life."|12 months ± 14 days|HRQoL Intent-to-Treat Analysis Dataset - comprised of all participants ≥14 years of age who were randomized, had any available assessments at any available study visits (baseline, 6- month, and 12-month) as defined in the protocol|||Scores on a scale||Standard Deviation|Mean
1450081|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Number of Days Lost (Work or School)||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Days||Standard Deviation|Mean
1450082|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Days||Standard Deviation|Mean
1450083|NCT00851721|Secondary|Pharmacoeconomics: Annual Total Length of Hospitalization for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Days||Standard Deviation|Mean
1450084|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Physician’s Office Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Physician's office visits||Standard Deviation|Mean
1450085|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Emergency Room Visits||12 months ± 14 days|Pharmacoeconomic Analysis Set|||Emergency room visits||Standard Deviation|Mean
1450086|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Indwelling Line||12 months ± 14 days|Pharmacoeconomic Analysis Set|||hospitalizations||Standard Deviation|Mean
1450087|NCT00851721|Secondary|Pharmacoeconomics: Annual Number of Hospitalizations for Bleeding||12 months ± 14 days|Pharmacoeconomic Analysis Set|||hospitalizations||Standard Deviation|Mean
1450088|NCT00851721|Secondary|Pharmacoeconomics: Annual Days Lost Due to Bleeding (Work or School)||12 months ± 14 days|Intent to Treat Analysis Set|||days||Standard Deviation|Mean
1450089|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia B Participants With Shifts in Factor IX (FIX) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):~Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)~Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)~Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)~Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set~- Hemophilia B study participants"|||Bethesda Units (BU)||Inter-Quartile Range|Median
1450090|NCT00851721|Secondary|Absolute Changes in Inhibitor Titer of Hemophilia A Participants With Shifts in Factor VIII (FVIII) Inhibitor Titer Levels|"Absolute Changes in Inhibitor Titer (or no change in low or high titer status):~Inhibitor Titer went from Low (≤5 BU) to Low (≤5 BU)~Inhibitor Titer went from Low (≤5 BU) to High (>5 BU)~Inhibitor Titer went from High (>5 BU) to Low (≤5 BU)~Inhibitor Titer went from High (>5 BU) to High (>5 BU)"|12 months ± 14 days|"Safety Analysis Set~- Hemophilia A study participants"|||Bethesda Units (BU)||Inter-Quartile Range|Median
1450091|NCT00851721|Secondary|Number of Related Thromboembolic Adverse Events (AEs)||12 months ± 14 days|Safety Analysis Set|||Related thromboembolic AEs|||Number
1450092|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) During or Within 1 Hour of Infusion Per Year||12 months ± 14 days|Safety Analysis Set|||Related AEs within/during 1hr per year||Inter-Quartile Range|Median
1450093|NCT00851721|Secondary|Rate of Related Adverse Events (AEs) Per Year||12 months ± 14 days|Safety Analysis Set|||Related AEs per year||Inter-Quartile Range|Median
1450094|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgM Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)~- Parvovirus B19 IgM Antibody [IV] (Parvo IgM Ab)"|12 months ± 14 days|Safety Analysis Set|||participants|||Number
1450095|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: Parvovirus B19 IgG Antibody [IV]|"Normal range (0 - 0.89 IV); High (> 0.89 IV)~- Parvovirus B19 IgG Antibody [IV] (Parvo IgG Ab)"|12 months ± 14 days|Safety Analysis Set|||participants|||Number
1450096|NCT00851721|Secondary|Viral Serology From Screening Visit and Study Termination Visit: HIV-1/2 Antibody (Ab)||12 months ± 14 days|Safety Analysis Set|||participants|||Number
1450106|NCT00851721|Secondary|Total Weight Adjusted Dose to Control a Bleeding Episode||12 months ± 14 days|"Additional Evaluations for Bleeding Episodes Analysis Set~- Consists of all participants with at least 1 bleeding episode treated with investigational product, FEIBA NF."|||Units/kg||Inter-Quartile Range|Median
1450107|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 24 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~24 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~24 hours after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~24 hours after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|24 ± 1 h post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)|||bleeding episodes|||Number
1450108|NCT00851721|Secondary|Assessment of Hemostasis for Treatment of Bleeding Episodes- Overall Efficacy Rating at 6 Hours|"Number of rAHF-PFM-treated bleeding episodes with an assessment of hemostasis (4-point ordinal scale):~Excellent: Full pain relief & bleeding cessation within ~6 hours of 1 infusion. Additional infusions may have been given to maintain hemostasis;~Good: Definite pain relief and/or improvement in bleeding within ~6 hours after infusion. Possibly requires >1 infusion for complete resolution;~Fair: Probable or slight relief of pain & slight improvement in bleeding within~~6 hours after infusion. Requires >1 infusion for complete resolution;~None: No improvement or condition worsens"|6 h ± 30 min post-infusion|Bleeding Episodes Analysis Set Consists of all participants who experienced a bleeding episode (BE)|||bleeding episodes|||Number
1450109|NCT00851721|Secondary|Assessment of Clinical Symptoms - Range of Motion (ROM)|ROM was measured using a goniometer for 3 key joints (ie, ankles, knees, and elbows) at screening, month 6, and termination (end of study visit)|12 months ± 14 days|Safety Analysis Set|||degrees||Inter-Quartile Range|Median
1450110|NCT00851721|Secondary|Assessment of Clinical Symptoms - Visual Analog Scale (VAS): Pain in Pediatrics (<12 Years Old)|"Pain caused by a bleeding episode (BE) in pediatric participants (<12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 h and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) using the children’s VAS pain scale (a facial expression scale with one end marked as no pain and the opposite end marked as the worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (worst possible pain).~Scores on the children's VAS scale are presented as:~No Pain~Mild Pain~Moderate pain~Severe pain~Very severe pain"|12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.|||Bleeding episodes|Bleeding episodes (BEs)||Number
1450111|NCT00851721|Secondary|Assessment of Objective Clinical Symptoms- Visual Analog Scale (VAS): Pain in Adolescents and Adults (≥12 Years Old)|"Pain caused by a bleeding episode in adolescents and adults (≥12 years old) was measured at pre-infusion (pre-inf) and at 6 ± 0.5 hours (h) and 24 ± 1 h post-infusion (post-inf) (after the last infusion given to treat a bleeding episode) on the VAS pain scale in millimeters from 0 (no pain) to 100 (worst possible pain). For analysis purposes, if short acting analgesics (duration of activity approximately 6 ± 0.5 h) were used, pain was assigned the highest possible score (100). Pain assessment occurred after each infusion related to single bleeding episodes. In case participants required an additional infusion within 24h, pain was assessed 6 ± 0.5 h and 24 ±1 h following the subsequent infusion.~Change in VAS scores at 6 ± 0.5 h and 24 ±1 h post-infusion were also compared relative to pre-infusion VAS scores (ie, (pre-infusion VAS score) - (post-infusion VAS score))."|Throughout the study period, 12 months ± 14 days|Additional evaluations for bleeding episodes in the intent-to-treat analysis dataset: consists of all participants with at least 1 bleeding episode treated with investigational product.|||Scores on a scale|Bleeding episodes|Inter-Quartile Range|Median
1450112|NCT00851721|Secondary|Number of New Target Joints|Target Joints are defined as ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows and hips|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||new target joints|||Number
1450113|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens: New Target Joints|"Annualized bleed rates (ABRs) were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using a two-sample, two-sided t-test.~The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||(bleeds/year)^(1/2)||Standard Deviation|Mean
1450114|NCT00851721|Secondary|Annualized Bleeding Rate for New Target Joints|Target joints are ≥4 bleeds/6 months in any one of the following joints: ankles, knees, elbows, and hips; a target joint bleeding episode refers to an individual anatomical location.|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||Bleeds per year||Inter-Quartile Range|Median
1450127|NCT00851630|Primary|Number of Serious Adverse Events (SAEs)|Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity.|104 weeks|Intention to treat.|||Events|||Number
1450115|NCT00851721|Secondary|Differences in Mean Transformed Annualized Bleeding Rate Between On-Demand and Prophylaxis Treatment Regimens by Bleeding Etiology, and Bleeding Type|"Annualized bleed rates were transformed using the square root of the number of bleeding episodes observed (X bleeds/year), X′ = √(X + 0.5). This transformation was performed to stabilize the variance and align the sample distribution with the assumption of normality inherent in using the t-test.~The difference in mean transformed ABRs was used to perform statistical tests and generate p-values at a significance level of 5%~Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:~On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician~Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period"|12 months ± 14 days|Efficacy Intent to Treat Analysis Dataset|||(bleeds/year)^(1/2)||Standard Deviation|Mean
1450116|NCT00851721|Secondary|Annualized Bleeding Rate by Treatment Regimen, Bleeding Etiology, and Bleed Type|Spontaneous includes unknown/undermined etiology|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||Bleeds per year||Inter-Quartile Range|Median
1450117|NCT00851721|Primary|Reduction in Annualized Bleeding Episode Rate (ABR) Among Participants Receiving Prophylactic Treatment as Compared to Those Treated On-demand|"Participants were Randomized to Receive 1 of the 2 Following Treatment Regimens:~On-Demand: FEIBA NF dose & dosing interval as prescribed by treating physician~Prophylaxis: 85 ± 15 U/kg of FEIBA NF every other day during 12-month prophylactic period~Annualized rate of bleeding episodes was calculated as:~(Number of bleeding episodes/observed treatment period in days) * 365.25"|12 months ± 14 days|"Efficacy Intent to Treat Analysis Dataset:~Dataset consists of data from all randomized participants. Dataset includes those who discontinued FEIBA NF but did not withdraw informed consent and were willing to continue providing data. For these participants, only the data collected before FEIBA NF discontinuation is included."|||bleeds/year||Inter-Quartile Range|Median
1450118|NCT00851682|Secondary|Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.|Ultrasound guidance of transrectal ultrasound biopsy was not attempted.|At time of treatment|||||||
1450119|NCT00851682|Primary|Improved Accuracy of Prostate Cancer Detection by MRI Scan.|Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.|At time of treatment|||||||
1450120|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."|||Participants|||Number
1450121|NCT00851643|Primary|Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A|A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.|4 weeks postdose 3 (Phase A)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."|||Participants|||Number
1450122|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase B)|"PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range."|||mMU/mL||95% Confidence Interval|Geometric Mean
1450123|NCT00851643|Primary|Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A|The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.|4 weeks postdose 3 (Phase A)|Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.|||mMU/mL||95% Confidence Interval|Geometric Mean
1450124|NCT00851630|Secondary|HIV RNA Level < 50 Copies/ml|The number of subjects with plasma HIV RNA level <50 copies/ml.|104 Weeks|Intent to Treat, missing = failure.|||Participants|||Number
1450125|NCT00851630|Secondary|Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml|The number of subjects with plasma HIV RNA level <400 copies/ml.|104 Weeks|Intention to Treat Analysis, missing = failure.|||Participants|||Number
1450126|NCT00851630|Primary|Tuberculosis-immune Reconstitution Inflammatory Syndrome Events|Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions.|104 weeks|Intention to treat.|||Events|||Number
1450128|NCT00851591|Secondary|Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.|"Milk-fat content was not measured in these samples as we had decided to close the study.~Protein content was not measured in these samples as we had decided to close the study."|day 0; day 8|0 patient samples||||||
1450129|NCT00851591|Primary|The Main Outcome Variable of This Study is the Quantity of Milk Produced.|The single value of this variable was calculated average from day 0 and day 8.|"Day 0 , Day 8"|||||||
1450130|NCT00851552|Secondary|Safety||2 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1450131|NCT00851552|Primary|Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21||at weeks 9 and 21|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
1450132|NCT00851409|Secondary|"The Evaluation of Pharmacokinetic/ Pharmacodynamic (PK/PD)Parameters."|"PK/PD parameters will be based on concentration time curves after the 1st and 8th rhC1INH administration.(ratio visit 8/ visit 1, based on the area under the curve from baseline up to 4 hours after administration (AUC 0-4)"|8 weeks||||ratio||95% Confidence Interval|Geometric Mean
1450133|NCT00851409|Primary|HAE Attacks/Week|"Prior to the treatment period, patients enrolled in the study, were asked about the amount of HAE attacks in the past 2 years, (calculated to attacks/week), this number is defined as Historical. During the treatment period, patients received a dose of 50 IU/kg of rhC1INH administered by slow IV injection over 4 to 5 minutes, once a week during an eight week period. The amount of attacks during this period is defined as Prophylaxis (calculated to attacks/week)."|8 weeks||||attacks/week||95% Confidence Interval|Mean
1450134|NCT00851318|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.~The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.|||units on a scale||Standard Deviation|Mean
1450135|NCT00851318|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count;~28 swollen joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity.~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~The data before study drug administration of 275-08-001 Study was utilized for Baseline.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
1450136|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug, with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1450137|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1450163|NCT00850642|Secondary|Percentage Change From Baseline of LTB4 Biomarker in Plasma|The plasma samples were evaluated for presence of LTB4 biomarkers. The percentage change from baseline was calculated by dividing the post-randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).|Day 1 and Day 12|All subject population.|||Percentage change||Standard Deviation|Mean
1451559|NCT00841815|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1450138|NCT00851318|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-001) were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1450139|NCT00851318|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.~A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).|||participants|||Number
1450140|NCT00851279|Primary|Percentage of Participants Free From VT at 1 Year Post-Treatment|In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.|1 Year follow-up||||percentage of participants free from VT|||Number
1450141|NCT00851253|Secondary|Rates of Adverse Events Associated With Treatment|Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment|1 year|One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed.|||Participants|||Count of Participants
1450142|NCT00851253|Primary|Duration of Local Control|Median time to local failure based on regional or distant metastatic disease|1 year|Boost subjects were not evaluable.|||number of months to local failure||Standard Deviation|Median
1450143|NCT00851084|Secondary|Immunogenicity of Intravenous (IV) Aflibercept|The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept.|Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status|Participants treated with aflibercept and evaluable for antibody assessment.|||participants|||Number
1450144|NCT00851084|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs.|From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized|Of the total 235 patients included in the safety population, 116 patients received mFOLFOX6 and 119 patients received mFOLFOX6 + aflibercept. One patient, randomly assigned to the mFOLFOX6 arm did not receive any study treatment and was therefore excluded from the safety analyses.|||participants|||Number
1450145|NCT00851084|Secondary|Overall Survival (OS)|"Overall survival was defined as the time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earliest between the last date the patient was known to be alive and the study cutoff date.~The study was not powered for comparison of OS between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Intent-to-treat population (ITT) – all participants who gave informed consent and were randomized. Of the 268 screened participants, 236 were randomly assigned to treatments, whereas 32 participants were screen failures.|||months|Participants|95% Confidence Interval|Median
1450146|NCT00851084|Secondary|Overall Objective Response Rate (ORR)|"Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.~Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study)."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable Patient population.|||percentage of participants||95% Confidence Interval|Number
1450147|NCT00851084|Secondary|Progression Free Survival (PFS)|"PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.~The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).~Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions."|From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)|Evaluable patient (EP) population. A total of 55 patients (32 in the mFOLFOX6 group and 23 in the mFOLFOX6 + aflibercept group) were without an event at the cutoff date for the PFS analysis by IRC.|||Months|Participants|95% Confidence Interval|Median
1450148|NCT00851084|Primary|Progression Free Survival (PFS) Rate at 12 Months|PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|12 months|Analyses of PFS rate was performed in the evaluable patient (EP) population as the primary analysis population. Overall, 9 patients from the randomized population were excluded from the EP population.|||percentage of participants||95% Confidence Interval|Number
1450149|NCT00851006|Secondary|31-phosphorus Magnetic Resonance Spectroscopy Phosphocreatine Metabolite|Phosphocreatine Metabolite is a phosphorylated creatine molecule that plays a role in the production of the energy in the body. Phosphocreatine (PCr) metabolite was quantified by calculating the ratio of PCr over total phosphorus resonance from 31-Phosphorus Magnetic Resonance Spectroscopy.|8 weeks||||ratio of PCr and total phosphorus||Standard Deviation|Mean
1450150|NCT00851006|Primary|Mean Children's Depression Rating Scale (CDRS-R) [Reference: Poznanski EO et al. Preliminary Studies of the Reliability and Validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984 Mar;23(2):191-7.]|The CDRS-R is a 17-item scale, with items ranging from 1 to 5 or 1 to 7 (possible total score from 17 to 113), rated by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission|8 weeks|"This outcome measure was not assessed in the Healthy Controls. Only subjects in treatment group were evaluated with CDRS-R and received scores."|||Units on a scale||Standard Deviation|Mean
1450151|NCT00850993|Secondary|Change From Baseline in Unadjusted Total Serum Bilirubin (TSB) at 48 Hours (ITT Population|Change from Baseline in Unadjusted TSB at 48 Hours (ITT Population)|48 hrs||||TSB (mg/dL)||95% Confidence Interval|Least Squares Mean
1450152|NCT00850993|Primary|The Primary Efficacy Endpoint Was the Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.|"The primary efficacy endpoint was the change in adjusted TSB from baseline to 48 hours after treatment.~The adjusted Total Serum Bilirubin (TSB) was a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the AAP Guidelines, ie, an indication of the distance below the PT threshold at the time."|48 hours after injection|Intent-to-treat population (ITT): Defined as all patients who were randomly assigned treatment in the clinical study, had received stannsoporfin or placebo, and had at least 1 post baseline TSB measurement during the first 48 hours after treatment. Patients were summarized based on randomized treatment.|||adjusted TSB (% of Threshold)||95% Confidence Interval|Least Squares Mean
1450153|NCT00850889|Secondary|Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity|Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14||||units on a scale||Standard Deviation|Mean
1450154|NCT00850889|Secondary|Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity|Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF|Day 0, Day 14||||units on a scale||Standard Deviation|Mean
1450155|NCT00850889|Secondary|Comparative Pain|A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.|1 day||||percent of participants|||Number
1450156|NCT00850889|Primary|Procedural Pain Score|Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.|1 day||||units on a scale||Standard Deviation|Mean
1450157|NCT00850759|Primary|Street-crossing Ability|average count of hits/close calls per participant in virtual environment, out of 30 crossings|post-training and again 6 months later||||number of hits/close calls||Standard Deviation|Mean
1450158|NCT00850720|Primary|NO Outcomes - Study Terminated Without Data.||Study terminated - no data.|||||||
1450159|NCT00850642|Secondary|Asthma Control Questionnaire (ACQ) Assessment|ACQ measures the adequacy of asthma control. It includes 5 questions about symptoms of asthma, 1 question about the rescue medication used and 1 about lung function (FEV1% predicted). This is a 7-item scale where the items are equally weighted and the ACQ score is the mean of 7 items which ranges from 0 to 6. 0= Well controlled and 6=extremely poorly controlled. Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Thus for ACQ a higher score indicates severe disease and a low score indicative of less severe disease.|At Day 1, Day 5 to 7 and Day 12|All Subject Population.|||Scores on scale||Standard Deviation|Mean
1450160|NCT00850642|Secondary|Assessment of Established Markers of Anti-inflammatory Activity in Sputum: the Measurements Will Include IL-17, Neutrophil Elastase, Myeloperoxidase and IL-8|During the study conduct it was observed that the levels of IL-17, measured in both blood and sputum were below limit of quantification; for neutrophil elastase, in sputum no inference could be made as most levels were above the limit of quantification. Thus due to limited amount of data the analysis was not summarized.|Day 1 and Day 12|All Subjects Population. Collected data were below the limit of quantification, so data could not be summarized||||||
1450161|NCT00850642|Secondary|Concentration of Interleukin (IL)-17 and High-sensitivity C-reactive Protein (hsCRP) in Blood|The blood samples were collected to evaluate the concentration of IL-17 and hsCRP in blood. However due to early termination of the study, the data was not collected.|Day 1 and Day 12|All Subject Population. Data not summarized for this parameter.||||||
1450162|NCT00850642|Secondary|Concentration of LTB4 in Sputum|The concentration of LTB4 levels in sputum were evaluated. However due to early termination of the study, the data was not collected.|Day 1 and Day 12|All Subject Population. Data not collected.||||||
1450164|NCT00850642|Secondary|Percentage Change From Baseline Urine LTE4 Biomarker|The urine spot samples were collected from the participants at pre-dose on day 1 and trough day 12 for evaluation of LTE4 biomarker. This evaluated the level of inflammation in the airways of the asthma participants. The percentage change from baseline was calculated by dividing the post randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).|Day 1 and Day 12|All subject population.|||Percent change||Standard Deviation|Mean
1450165|NCT00850642|Secondary|Plasma Concentration of GSK2190915|The blood samples for analysis of pharmacokinetic parameters were collected at pre-dose and 2 hours post dose on Day 1 and pre-dose trough and 2 hour post dose on Day 12, to evaluate the concentration of the drug GSK2190915 in plasma.|At Day 1, pre-dose; Day 1, 2 hour; Day 12, pre-dose; and Day 12, 2 hour|All Subject Population.|||Nanogram per millilitre||Standard Deviation|Mean
1450166|NCT00850642|Secondary|Number of Participants With Hematology Values of PCC|The hematology parameters evaluated were white blood cells, neutrophils, hemoglobin, hematocrit, platelets and lymphocytes. The number of participants with values outside the PCC values were reported. The PCC value observed for lymphocyte was reported.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All subject population.|||Participants|||Count of Participants
1450167|NCT00850642|Secondary|Number of Participants With Clinical Chemistry Values of PCC|The clinical chemistry parameters evaluated were albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium, urea, gamma glutamyl transferase, and bicarbonate. The number of participants with values outside the PCC values were reported. The PCC value observed for bicarbonate was reported.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All subject population.|||Participants|||Count of Participants
1450168|NCT00850642|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|The number of participants with abnormal ECG values were reported. The data was reported as Abnormal clinically significant (CS), abnormal not clinically significant (NCS), and No result.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All Subject Population.|||Participants|||Count of Participants
1450169|NCT00850642|Secondary|Number of Participants With Vital Sign of Potential Clinical Concern (PCC)|The vital sign measurement included measurement of systolic and diastolic blood pressure alongwith pulse rate. The PCC values reported for systolic blood pressure were < 85 millimeter of mercury (mmHg) and >160 mmHg; that for diastolic was <45 mmHg and >100 mmHg. The PCC values for pulse rate were <40 and > 110 beats per minute. The number of participants with values outside the PCC for systolic, diastolic blood pressure and vitals during the treatment duration were reported.|Visit 2 (Day 1) to Upto follow-up (Day 28)|All subject population.|||Participants|||Count of Participants
1450170|NCT00850642|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|From visit 1 (Day -7 to Day -9) to upto follow-up (upto Day 28)|All Subject Population.|||Participants|||Count of Participants
1450171|NCT00850642|Secondary|Assessment of FEV1 on Visit 2, 3 and Visit 4|FEV1 is the amount of air which can be forcefully exhaled in 1 second. It was assessed using a spirometry. Due to early termination of the study, the data of individual participants is reported.|Visit 2 (Day 1), visit 3 (Day 5 to 7) and visit 4 (Day 12)|All Subject population. Individual participant data reported, due to early termination of study. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Liters|||Number
1450172|NCT00850642|Primary|Percentage of Neutrophils in Induced Sputum|The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 g, or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as percentage of cells.|Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)|All Subject Population. Only those participants available at the specified time points were analyzed.|||Percentage of neutrophils||Standard Deviation|Mean
1450173|NCT00850642|Primary|The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count|The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 grams (g), or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as total cell count × 10^6 /g.|Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)|All Subject Population was defined as all participants who receive at least one dose of study medication.|||Giga cells per g||Standard Deviation|Mean
1450174|NCT00850603|Primary|Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.|GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.|Baseline (Day 0) and Day 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1450175|NCT00850603|Secondary|Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.|Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®|Day 0 to 7 days post-vaccination||||Participants|||Number
1450212|NCT00850174|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Results of Metabolite for Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1450176|NCT00850603|Primary|Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers|Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.|Baseline to 28 days post vaccination|4-Fold rise analysis was in the per-protocol population with valid serology data|||Percentage of participants|||Number
1450177|NCT00850564|Secondary|Insulin Stimulated Glucose Utilization|Insulin stimulated glucose uptake (M) is the amount of glucose (measured in mg per kg body weight per minute) taken up during the steady state period of a euglycemic hyperinsulinemic clamp. This measure was calculated for minutes 100-120 of euglycemic hyperinsulinemic clamp procedure at 2 weeks (i.e., after 2 weeks treatment with growth hormone releasing hormone). The measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)||||mg/kg/min||Standard Error|Mean
1450178|NCT00850564|Primary|Mean Overnight Growth Hormone|Outcome is mean overnight growth hormone at 2 weeks (i.e., following 2 weeks of treatment with growth hormone releasing hormone). Growth hormone was measured overnight (from 8pm-7:40am) by frequent blood sampling, and the mean is the average of these frequent measurements. The mean measurement at 2 weeks is given here, and, in the statistics section, is statistically compared with the mean measurement before treatment.|at 2 weeks (i.e., after 2 weeks of treatment)|analysis of 13 participants who completed both baseline and 2 week visits|||mcg/L||Standard Error|Mean
1450179|NCT00850538|Primary|Number of Participants With Viable Specimens for Genetic Analysis||Tissue samples collected at time of surgery||||participants|||Number
1450180|NCT00850499|Secondary|Overall Response Rate|The proportion of subjects who achieve CR, CRu, or partial response (PR) relative to the response evaluable population. Disease response and progression were evaluated according to the modified IWRC criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug|||participants|||Number
1450181|NCT00850499|Primary|Complete Response Rate|The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.|Up to 8 cycles (1 cycle is 35 days: 280 days)|Received at least one dose of study drug|||participants|||Number
1450182|NCT00850473|Primary|Number of Participants With Clear Anatomical Landmarks Confirmed by CT|Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography.|During PET CT scan, an average of 2 hours||||Participants|||Count of Participants
1450183|NCT00850460|Primary|Individualized Short Form-36 (SF-36) Mean Scores (Physical Component) From Week 0 to Week 8|Scores from the self-administered SF-36 (Physical component) questionnaire were measured at the start (Week 0) of the study and at the end (Week 8) among patients in the placebo- and statin-treated group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of scores.|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.|||units on a scale||Full Range|Mean
1450184|NCT00850460|Primary|Individualized Neuromuscular Quality of Life (INQoL) Mean Scores From Week 0 to Week 8|Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Week 0) and at the end (Week 8) between the statin-treated group and the placebo group. Scores range from 0-100, with 100 being a better outcome. Measures reported are the means of Week 0 and week 8, measures of dispersion is the range of the results (3 per group).|Week 0 to Week 8|Three patients from each group completed the questionnaire portion of the study at Week 0 and Week 8.|||units on a scale||Full Range|Mean
1450185|NCT00850421|Secondary|To Assess the Effect of BOTX Injections on the Frequency and Intensity of Migraine Episodes in Subjects With Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. PI has since left and data no longer available.||||||
1450186|NCT00850421|Secondary|To Determine Whether Quality of Life is Improved in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. PI has since left and data no longer available.||||||
1450187|NCT00850421|Primary|To Determine Whether Resource Utilization is Decreased in Subjects Treated With BOTOX Injections for Episodic Migraine Headache.||190 days|Mid-enrollment statistical review determined study should not continue, due to recently published BOTOX efficacy data and study design deficits. PI has since left and data no longer available.||||||
1450188|NCT00850395|Secondary|Number of Participants Taking Concomitant Therapy|Participants taking HIV/AIDS concomitant medication at Month 12, at Baseline and Month 12 were reported. It included Emtricitabine/tenofovir disoproxil fumarate(FTC/TDF),Raltegravir(RAL), Ritonavir (RTV), Darunavir(DRV), Kaletra, Atazanavir sulfate(ATV), Abacavir sulfate/lamivudine(ABC/LAM), Tenofovir disoproxil fumarate(TDF), Etravirine(ETR), Lamivudine (LAM), Zidovudine W/lamivudine(ZDV W/LAM), Nevirapine(NVP), Saquinavir mesilate(SQV), Trizivir(TZV), Zidovudine(ZDV), Abacavir sulfate(ABC), Emtricitabine(FTC),Entecavir(ETV).|Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.|||participants|||Number
1450189|NCT00850395|Secondary|Physician's Assessment of Efficacy|Number of participants with each grade of efficacy as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.|||participants|||Number
1450190|NCT00850395|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV) Response|Response was defined as a HIV-1 RNA count of less than 50 copies/mL.|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication.|||participants|||Number
1450213|NCT00850174|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1450191|NCT00850395|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12|SDM consists of the 20 items questionnaire, each item rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). A positive change from baseline indicates a decline in a participant’s quality of life over that period.|Baseline, Months 6, 12|FAS population. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable at specified time point. Missing values were imputed only for Month 12 as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||units on a scale||Standard Deviation|Mean
1450192|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||participants|||Number
1450193|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1450194|NCT00850395|Primary|Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3|Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).|Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1450195|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||cells/mcL||Standard Deviation|Mean
1450196|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1450197|NCT00850395|Primary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3||Baseline, Month 3|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||cells/mcL||Standard Deviation|Mean
1450198|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12||Baseline, Month 12|FAS population included all participants who received at least one dose (including partial doses) of study medication. Missing values were imputed as zero for those participants who either discontinued prematurely before the final visit or had missing baseline measurements.|||copies/mL||Standard Deviation|Mean
1450199|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6||Baseline, Month 6|FAS population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||copies/mL||Standard Deviation|Mean
1450200|NCT00850395|Primary|Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3||Baseline, Month 3|Full Analysis Set (FAS) population included all participants who received at least one dose (including partial doses) of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||copies/mL||Standard Deviation|Mean
1450201|NCT00850343|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS)|"X-ray images of extremities (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by at least two radiographic readers.~The degree of joint destruction was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline (of Study 275-08-003), Week 0 (of this study) and Week 100|Full analysis set with available mTSS data. Linear extrapolation method was used.|||units on a scale||Standard Deviation|Mean
1450214|NCT00850174|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis. AUC0-inf was not able to be estimated from all data sets.|||ng*h/mL||Standard Deviation|Mean
1450215|NCT00850174|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1450352|NCT00849147|Secondary|Secondary Graft Failure|Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure.|Measured at Day 100||||participants|||Number
1450202|NCT00850343|Secondary|Change From Baseline in Disease Activity Score (DAS) 28|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count;~28 swollen joint count;~Erythrocyte sedimentation rate (ESR);~Patient's global assessment of disease activity.~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~The data before study drug administration of 275-08-003 Study was utilized for Baseline.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score of 3.2 or less indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|"The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used. N indicates the number of participants with available data at each time point."|||units on a scale||Standard Deviation|Mean
1450203|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|"A participant was an ACR70 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1450204|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|"A participant was an ACR50 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1450205|NCT00850343|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|"A participant was an ACR20 responder if the following 3 criteria for improvement from Baseline (before study drug administration in Study 275-08-003) were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of arthritis pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));~C-Reactive Protein (CRP)."|Baseline (of Study 275-08-003), Week 24, Week 52 and at the final assessment (maximum was 208 weeks)|The full analysis set (FAS) included all randomized participants who received at least one dose of study drug with at least one post-baseline efficacy data point. Last observation carried forward (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
1450206|NCT00850343|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows:~Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities.~A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect."|From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.|All participants who received at least one study drug administration were included in the safety analysis population (SAF).|||participants|||Number
1450207|NCT00850200|Secondary|Assess Disease Control and Survival Outcomes||During radiation therapy; then after radiation, every 3 months for the first year, then every 6 months for the next 4 years, then annually|||||||
1450208|NCT00850200|Secondary|Assess Improvement and Other Dosimetric Endpoints||Prior to starting radiation therapy|||||||
1450209|NCT00850200|Primary|Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.||Immediately proceeding completion of each of the three treatment plans||||percentage of body receiving 4 Gy||Full Range|Median
1450210|NCT00850174|Secondary|AUC0-t - 10-hydroxy-carbazepine Metabolite|Results of metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1450211|NCT00850174|Secondary|AUC0-inf - 10-hydroxy-carbazepine Metabolite|Results of Metabolite for informational purposes only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1450216|NCT00850135|Secondary|Pregnancy and Delivery Characteristics for Participants With AUC-130 <= 22,000 and AUC-130 > 22,000|"For our secondary outcome analyses,we chose to focus on AUC-130 because 130 mg/dL is a common threshold used when treating gestational diabetics. In addition, 130 mg/dL was the threshold used in an earlier pilot study performed at our institution because it had the best correlation with birth weight percentile.~Secondary outcomes were compared between these two groups using the chi-square test. Data were analyzed using Stata 11.2. AUC-130 values were divided into “high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values."|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|A total of 57 patients were enrolled from two clinical sites. Of these patients, 44 were screened with the 1-hour 50-g GCT; 9 were screened with 2-hour 75-g GTT. Complete data on secondary outcomes was available for 43 patients with 1-hour 50-g GCT and these were analyzed.|||participants|||Number
1450217|NCT00850135|Primary|Correlation Between Glucose AUC and Birth Weight.|For each patient’s CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values “AUC-110,” “AUC-120,” “AUC-130,” “AUC-140,” and “AUC-180,” and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.|CGM measured 7 days at beginning of pregnancy,birth weight measured a time of delivery|"A total of 57 patients were enrolled from two clinical sites. Two patients did not have monitoring or delivery data.~Two patients who had an existing diagnosis of diabetes were excluded. The remaining 53 patients were analyzed."|||correlation coefficient|||Number
1450218|NCT00850096|Secondary|Overall Glycemic Control|Continuous glucose monitoring (CGM) data from patients at the last weeks of study (week 5-6) were averaged for assessment of glycemic control under the treatment of either Nasulin or placebo.|5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.|||mg/dl||Standard Error|Mean
1450219|NCT00850096|Primary|Continuous Glucose Monitoring (CGM)|Continuous glucose monitoring (CGM) data from patients receiving either Nasulin or placebo were collected and compared at baseline and the last two weeks of the study, and changes (week 5-6 minus baseline) in the mean percentage of time spend in euglycemia (70 to 180 mg/dl blood glucose) (MPTEU) were assessed from baseline Week 0 to Week 5-6.|Baseline and 5-6 weeks|47 patients were randomized to the placebo/oral antidiabetic arm while 47 others were randomized to the Nasulin/oral antidiabetic arm of the study. Forty-four patients in the placebo + oral antidiabetic arm and 45 patients in the Nasulin + oral antidiabetic arm completed the study.|||Percentage of day (24h) in euglycemia||Standard Error|Mean
1450220|NCT00850070|Secondary|Parent Global Assessment (PGA) Scale|This is a measure where parents rate their impression of their child's improvement, in a global manner.|Baseline, 8 weeks, and 16 weeks|Data was not analyzed secondary to lack of significant findings in primary outcome measures and limited data collected on this instrument. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
1450221|NCT00850070|Secondary|Social Responsiveness Scale (SRS)|The SRS is a 65-item scale used to measure the severity of symptoms in ASD as they occur in natural social settings. The SRS is comprised of 1 Total scale and 5 subscales that generate raw scores that can be converted to standard T-scores (with mean of 50 and standard deviation of 10) for gender and rater type; standard scores were selected for use in this study. A total T-score of 76 or higher is considered severe and strongly associated with a clinical diagnosis of autistic disorder. A t-score of 60-75 is in the mild to moderate range and considered typical for children with mild or 'high-functioning' ASD, while a T-score of 59 or less suggests an absence of ASD symptoms. A total raw score of >75 were associated with a sensitivity value of .85 and a specificity value of .75 for ASD. Difference in scores between baseline and week 16 were used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.|||units on a scale||Standard Deviation|Mean
1450222|NCT00850070|Secondary|Aberrant Behavior Checklist (ABC) - Inappropriate Speech|Subscale assessing echolalia & other odd speech. Higher subscale scores indicate more symptoms. 4 items comprise the subscale, with range of scores from 0-4. Total score range on this subscale is 0 to 16. Scores are averaged to compute overall score. Difference in scores between baseline and week 16 were used as indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent to treat analysis|||units on a scale||Standard Deviation|Mean
1450223|NCT00850070|Secondary|Adverse Events Scale|This was not a standardized scale but a set of questions that was asked of each family - some standard and others open ended.|Every 1-2 weeks for 16 weeks|We did not specifically analyze this data but instead use it as a guide to determine if a drug should be discontinued for a particular child.||||||
1450224|NCT00850070|Secondary|Connor's Preschool ADHD Questionnaire|Conners Early Childhood, addresses child behavior for ages 2 years to 6 years with a variety of scales, including an ADHD subdomain.|Baseline, 8 weeks, and 16 weeks|Data was not analyzed secondary to lack of significant findings in primary outcome measures and limited data collected on this instrument. The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
1450243|NCT00849901|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
1450353|NCT00849147|Secondary|Primary Graft Failure|Primary graft failure is defined as < 5% donor chimerism on all measurements.|Measured at Day 67||||participants|||Number
1450225|NCT00850070|Secondary|Children's Yale Brown Obsessive Compulsive Scale (C-YBOCS)|The C-YBOCS is a scale is designed to rate the severity of obsessive and compulsive symptoms in children and adolescents, ages 6 to 17 years. It can be administered by a clinican or trained interviewer in a semi-structured fashion. In general, the ratings depend on the child's and parent's report; however, the final rating is based on the clinical judgement of the interviewer. Rate the characteristics of each item over the prior week up until, and including, the time of the interview. Scores should reflect the average of each item for the entire week, unless otherwise specified.|Baseline, 8 weeks, and 16 weeks|The data was not analyzed secondary to lack of significant findings in the primary outcome measure. Also, limited data collected secondary to the age range of the children we saw.The data cannot now be provided as the research team has since disbanded and it is not possible to reanalyze the data at this time.||||||
1450226|NCT00850070|Secondary|Vineland Adaptive Behavior Scale-II.|the Vineland-2 is a semi-structured interview designed to assess communicatino, daily living, socialization and motor skills. The Vineland-2 is comprised of a total Adaptive Composite scale; we chose to use 10 subscales that specifically address functional domains relevant for a young ASD sample - Receptive Communication, Expressive Communication, Personal Daily Living Skills, Domestic Daily Living Skills, Community Daily Living Skills, Interpersonal Relations, Play Skills, Coping Skills, Gross Motor Skills, Fine Motor Skills. Scales generate raw or sum, V-, and age-equivalent scores; raw scores were selected for use in the study. Raw score ranges from 0 to 108 depending on the scale. Total raw scale range is from 0 to 766. Subscale scores are averaged to create the total adaptive behavior composite. Higher subscale scores indicate more skills. Difference between baseline and week 16 was used as an indicator of change.|Primary outcome assessment used two time points, baseline and 16 weeks.|Intent-to-treat analysis; all subjects included. Includes mean at 16-week outcome.|||units on a scale||Standard Deviation|Mean
1450227|NCT00850070|Secondary|Preschool Language Scale-Fourth Edition (PLS-4). Assesses Expressive and Receptive Language Skills in Ages Birth Through 6 Years, 11 Months.|Measures expressive & receptive language and total scores in ages birth to 6 years 11 months. The scales generate raw, standard, and age-equivalent scores; raw scores for the total scale were selected for use in this study. Total is average of subscales. Minimum raw score = 0, maximum = 130. Higher scores indicate better language abilities. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. For the outcome effect, the difference between baseline and 16 weeks was determined as an indicator for change.|Primary outcome assessment examined the difference in scores between baseline and week 16.|Intent-to-treat analysis; all subjects included. Difference in scores between baseline and 16 weeks was used as treatment outcome.|||units on a scale||Standard Deviation|Mean
1450228|NCT00850070|Primary|Clinical Global Impression -- Severity (CGI-S) Scale|The CGI-S assessed the number of participants with improved severity illness on the CGI-S scale. This is a summary judgment made by a trained clinician of symptom severity. It is a 7-point scale that rates the severity of the patient's illness at time of assessment with 1 - normal, not at all, to 7 - extremely ill. Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Baseline, 8 weeks, and 16 weeks. Primary outcome assessment used 2 time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at number of children who improved (from markedly, severely or extremely ill to markedly, mildly or no illness) at 16-week time frame.|||participants|||Number
1450229|NCT00850070|Primary|Clinical Global Impression -- Improvement (CGI-I) Scale|The CGI-I assessed the number of participants showing much or very much improvement on the CGI-I scale. This is a summary judgment made by a trained clinician based on observed and reported behaviors of the child compared to baseline. It is a 7-point scale from very much worse (1) to very much improved (7). Chi-square analyses were used to assess change in CHI-I scores (by group, post-test). Mixed-effects regression models via SPSS MIXED determined the main effects attributed to differences by group (BH4 and placebo), time (treated as categorical at levels baseline, 8 weeks, and 16 weeks) and the group-by-time interaction. We used random intercept and trend modeling that accounts for each individual's initial level of symptom severity/functioning and rate of change/time|Weekly for 4 weeks, then monthly, with 16-week end point. Primary outcome assessment used two time points, baseline and 16 weeks.|This was an Intent-to-Treat Analysis with Last Observation Carried Forward.Analyses looked at percentage of children who improved (showing much or very much improved ratings) at 16-week time frame.|||participants|||Number
1450230|NCT00850031|Secondary|Improvement of Near Uncorrected Visual Acuity|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months||||units on a scale||Standard Deviation|Mean
1450231|NCT00850031|Primary|Improvement in Uncorrected Near Visual Acuity|Percent of subjects who achieved UCNVA of 20/40 or better.|12 months||||percentage of participants|||Number
1450232|NCT00849940|Secondary|Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.||Data collected from individual participants over 4 hour timeframe|Data not collected.||||||
1450233|NCT00849940|Secondary|Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation||Data collected from individual participants over 4 hour timeframe|Data not collected||||||
1450234|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation|The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 25.4 kg; age 0.04 - 10.2 years represent the values of the participants analyzed.|||percentage of oxygen saturation||Standard Deviation|Mean
1450235|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation|The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.|Data collected from individual participants over 4 hour timeframe.|Weight 2.9 - 24.0 kg; age 0.04 - 9.8 years represent the values of the participants analyzed.|||percentage of oxygen saturation||Standard Deviation|Mean
1450236|NCT00849940|Primary|Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation|"The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.~oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry."|Data collected from individual participants over 4 hour timeframe.|Weight range 3.9 - 49.5 kg; age 0.2 - 12.3 years represent the values of the participants analyzed.|||percentage of oxygen saturation||Standard Deviation|Mean
1450237|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥ 5mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participants with normal value at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.|||percentage of participants|||Number
1450238|NCT00849901|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.|||percentage of participants|||Number
1450239|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.|||participants|||Number
1450240|NCT00849901|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT <1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.|||participants|||Number
1450241|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
1450242|NCT00849901|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 - 0)."|Baseline through Week 10|Participants with at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
1450354|NCT00849147|Secondary|Neutrophil Recovery|Cumulative incidence of neutrophil recovery >500/μL at day +56|Measured at Days 28, 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
1450244|NCT00849901|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1450245|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
1450246|NCT00849901|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1450247|NCT00849901|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Deviation|Least Squares Mean
1450248|NCT00849901|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1450249|NCT00849875|Secondary|Number of Patients With Any Serious Adverse Events (SAEs) and With AEs by Maximum Grade|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.|Within the 31-day follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450250|NCT00849875|Secondary|Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade|An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5.|Within the 31-day follow-up period post treatment administration.|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450251|NCT00849875|Secondary|Number of Patients With Abnormal Platelets(PLT) Values by Maximum Grade|The status of each patient as regards PLT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450252|NCT00849875|Secondary|Number of Patients With Abnormal Partial Thromboplastin Time (PTT) Values by Maximum Grade|The status of each patient as regards PTT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450274|NCT00849875|Secondary|Time to Treatment Failure (TTF), by Gene Signature|TTF was defined as withdrawal from treatment with the MAGE-A3 ASCI study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
1450253|NCT00849875|Secondary|Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade|The status of each patient as regards NEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450254|NCT00849875|Secondary|Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade|The status of each patient as regards LYM laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450255|NCT00849875|Secondary|Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade|The status of each patient as regards LEU laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450256|NCT00849875|Secondary|Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade|The status of each patient as regards hNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450257|NCT00849875|Secondary|Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade|The status of each patient as regards hKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450258|NCT00849875|Secondary|Number of Patients With Abnormal Hypocalcemia(hCA) Values by Maximum Grade|The status of each patient as regards hCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450259|NCT00849875|Secondary|Number of Patients With Abnormal Hypoalbuminemia(hAL) Values by Maximum Grade|The status of each patient as regards hAL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450260|NCT00849875|Secondary|Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade|The status of each patient as regards HNA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450261|NCT00849875|Secondary|Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade|The status of each patient as regards HKA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450262|NCT00849875|Secondary|Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade|The status of each patient as regards HCA laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450263|NCT00849875|Secondary|Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade|The status of each patient as regards HGB laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450264|NCT00849875|Secondary|Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade|The status of each patient as regards GGT laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G3. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450265|NCT00849875|Secondary|Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade|The status of each patient as regards CREA laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450266|NCT00849875|Secondary|Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade.|The status of each patient as regards BIL laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Unknown (UNK) and Grade 0 (G0). CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450267|NCT00849875|Secondary|Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade|The status of each patient as regards ALK laboratory values at baseline (SCR) up to study end(SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450268|NCT00849875|Secondary|Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade|The status of each patient as regards AST laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0) and G1. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of GSK2132231A.|||Subjects|||Number
1450269|NCT00849875|Secondary|Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade|The status of each patient as regards ALT laboratory values at baseline (SCR) up to study end (SE) was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were Grade 0 (G0), G1 and G2. CTC grade statuses reported at SE were G0, G1, G2, G3, G4, and Unknown (UNK).|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Subjects|||Number
1450270|NCT00849875|Secondary|Overall Survival (OS) by Gene Signature|OS was defined as the time from first treatment to the date of death. OS analysis was performed using the non-parametric Kaplan-Meier method. Each patient was censored out at the time of death.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
1450271|NCT00849875|Secondary|Progression-free Survival (PFS) After Slow Progressive Disease (SPD) by Gene Signature|PFS after initial SPD was defined and calculated as the time from the time point at which the disease was the most advanced during the treatment to either a new progression of the disease or the date to death, whichever occurred first as another secondary outcome of this study. In that case, the largest diameter during the course of treatment was to be used as reference measurement. This outcome was defined to take into account the delay to induce an active immune response and the strict rules set up in this study to allow pursuing investigational treatment in case of SPD. PFS after SPD analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
1450272|NCT00849875|Secondary|Progression-free Survival (PFS) by Gene Signature|PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
1450273|NCT00849875|Secondary|Progression-free Survival (PFS) for the Overall Population|PFS was defined and calculated as the time from first treatment to either the first progression of the disease or the date of death, whichever occurred first. In case a patient went off protocol treatment, the date of first documented progression (if applicable) was to be used as date of progression. Patients still alive with no evidence of disease progression at the time of their last visit or for whom date of first documented progression was not applicable, were censored at the time of the last examination. PFS analysis was performed using the non-parametric Kaplan-Meier method.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
1450355|NCT00849147|Primary|Overall Survival at 180 Days From the Time of Transplant||Measured at Month 6 and Year 1||||percentage of participants||95% Confidence Interval|Number
1450275|NCT00849875|Secondary|Number of Patients With Mixed Response (MxR) to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. MLs were assessed as regards matching below MxR definitions. In case of evaluability per RECIST: a) MxR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL, and = SD/PR with new lesion. In case of non-evaluability per RECIST: a) MxR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions = SD/PD with TL regression; b) MxR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL = SD/PR with new lesion.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
1450276|NCT00849875|Secondary|Duration of Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. Stable disease was defined as follows: 1) In case of target lesions (TL) greater than or equal to (≥) 20 mm: neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as references the sum of Longest Diameter (LD) of TL recorded previously but not necessarily at baseline; 2) In case of TL both less than 20 mm and ≥ 20 mm: Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since the start of the treatment. The minimal time interval required between 2 measurements for determination of SD was at least 12 weeks.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Months||95% Confidence Interval|Median
1450277|NCT00849875|Secondary|Number of Patients With Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment|Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. TLs and NTLs were assessed as regards matching or not SD-related definitions, 1) SD definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria for TLs >= 20 mm and TLs both >= and < 20 mm: a) for TLs: SD = Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since treatment start. and b) for NTLs: SD = Persistence of one or more NTL; 2) following below criteria for TLs < 20mm e. a. a) for TLs: PR/SD = Neither sufficient shrinkage to qualify for CR nor sufficient increase, to qualify for PD taking as references the smallest sum LD since treatment start, and b) for NTLs: PR/SD = Persistence of one or more NTL.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||patients|||Number
1450278|NCT00849875|Secondary|Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment|Response assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs), and followed up until disease progression. Up to 5 MLs per organ & 10 in total were identified as TLs and measured at baseline, selected based on size (those with the longest diameter [LD]) and measurability; a sum of LDs for all TLs was calculated and reported as baseline sum LD, which was used to characterize objective tumor response (OR), OR being defined as either complete response (CR) and/or partial response (PR) post MAGE-A3 ASCI treatment. After identification, MLs and TLs were assessed as regards CR and PR definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR = Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis; PR = At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters.|During the entire study, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||patients|||Number
1450279|NCT00849875|Primary|Anti-MAGE-A3 Antibody Concentrations (CMI)|Analysis of MAGE-A3 cellular response was not performed and data were not collected..|Post Dose 4 at Week 13 (W13).|||||||
1450280|NCT00849875|Primary|Number of Patients With Treatment Response for Anti-PD|Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 100 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||Patients|||Number
1450281|NCT00849875|Primary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-PD antibody concentrations were presented ad geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL).|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1450282|NCT00849875|Primary|Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies|Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||Patients|||Number
1450283|NCT00849875|Primary|Anti-MAGE-A3 Antibody Concentrations|Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL)|Post Dose 4 at Week 13 (W13).|The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1450408|NCT00848744|Secondary|The Subject's Medication Side Effect Profile Will be Assessed Using a Application Site Scale for Dryness, Scaling, Redness, and Stinging/Burning.||4 Weeks|Data were not collected.||||||
1450284|NCT00849875|Primary|Number of Seroconverted Patients for Melanoma Antigen (Anti-MAGE-A3)|Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27.|Post Dose 4 at Week 13 (W13).|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
1450285|NCT00849875|Primary|Number of Patients Reported With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Events which were part of the natural course of the disease under study (i.e., disease progression, recurrence) were captured as part of the clinical activity outcome variables in this study; therefore these did not need to be reported as SAEs. Progression/recurrence of the tumor in a patient was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE.|During the entire study period, up to 5 years|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
1450286|NCT00849875|Primary|Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade.|The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the treatment.|Within the 31-day (Days 0-30) post-administration period.|The Total Treated population included all patients who have received at least one dose of the GSK2132231A product.|||Patients|||Number
1450287|NCT00849862|Primary|AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1450288|NCT00849862|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1450289|NCT00849862|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
1450290|NCT00849810|Primary|Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.||4 weeks (pre- and post-treatment)||||mm HG||Standard Deviation|Mean
1450291|NCT00849797|Secondary|AUC0-t - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1450292|NCT00849797|Secondary|AUC0-inf - 10-Hydroxy-Carbazepine Metabolite|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1450293|NCT00849797|Secondary|Cmax - 10-hydroxy-carbazepine in Plasma|Informational Purposes Only|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1450294|NCT00849797|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1450295|NCT00849797|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1450296|NCT00849797|Primary|Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1450297|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Week 10 Through Week 36|PCS increase in systolic and diastolic BP was defined as increase of ≥5 mm Hg from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Week 10 through Week 36|Participates with normal value before week 10 and at least one non-missing post-Week 10 value, and who are at risk for the specific PCS criteria.|||percentage of participants|||Number
1450307|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1450298|NCT00849693|Secondary|Percentage of Participants With Potentially Clinically Significant (PCS) Changes in Systolic Blood Pressure (BP), Diastolic BP, Pulse, and Weight Any Time Baseline Through Week 10|PCS increase in systolic and diastolic BP was defined as increase of ≥5 millimeter mercury (mm Hg) from baseline (BL) high value to a value above the 95th percentile at post-BL; PCS increase of pulse was defined as >140 and increase of ≥15 from BL high value for age 7-11 and >120 and increase of ≥15 from BL high value for age 12-17; PCS decrease of pulse was defined as <60 and a decrease of ≥25 from BL low value for age 7-11 and <50 and a decrease of ≥15 from BL low value for age 12-17; PCS decrease of weight was defined as decrease of at least 3.5% from BL low value.|Baseline through Week 10|Participants with normal baseline value and at least one post-baseline value, and who were at risk for the specific PCS criteria.|||percentage of participants|||Number
1450299|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Week 10 Through Week 36|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as ALT ≥3 x ULN, ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT≥3 x ULN and Total Bilirubin ≥2 x ULN.|Week 10 through Week 36|Participants with normal ALT value (ALT<1 x ULN) at last non-missing visit before Week 10 and at least one non-missing post-Week 10 value.|||participants|||Number
1450300|NCT00849693|Secondary|Number of Participants With Potentially Clinically Significant Hepatic Laboratory Results Any Time Baseline Through Week 10|Total number of participants with any abnormal post-baseline value, based on all values at scheduled and unscheduled visits. Potentially clinically significant hepatic laboratory results at any time are defined as alanine transaminase (ALT) ≥3 x upper limit of normal (ULN), ALT ≥5 x ULN and ALT ≥10 x ULN, as well as ALT ≥3 x ULN and Total Bilirubin ≥2 x ULN.|Baseline through Week 10|Participants with normal ALT value (ALT<1 x ULN) at last non-missing baseline visit and at least one non-missing post-baseline value.|||participants|||Number
1450301|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Week 10 Through Week 36|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week 7-10)."|Week 10 through Week 36|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
1450302|NCT00849693|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior Baseline Through Week 10|"Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Treatment Emergent Suicidal Ideation is worsening or new occurrence of events during treatment compared to lead-in baseline (Week -1 to 0)."|Baseline through Week 10|Participants with a baseline and at least one post-baseline C-SSRS suicidal ideation or suicidal behavior score and who are at risk for treatment emergent suicidal ideation or behavior.|||participants|||Number
1450303|NCT00849693|Secondary|Change From Week 10 in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 36 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
1450304|NCT00849693|Secondary|Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10 Endpoint|CGI-Severity evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1450305|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 36 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
1450306|NCT00849693|Secondary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Subscale Score at Week 10 Endpoint|CDRS-R Subscale scores include Mood (Sum of items 8, 11, 14, 15), Somatic (Sum of items 4-7, 16, 17), Subjective (Sum of items 9, 10, 12, 13) and Behavior (Sum of items 1-3). Mood and Subjective subscale scores range from 4 to 28; Somatic subscale scores range from 6 to 36; Behavior subscale scores range from 3 to 21. Higher score indicates greater severity of disease. LS means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline values.|||units on a scale||Standard Error|Least Squares Mean
1450322|NCT00849472|Secondary|Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods|The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges.|up to 24 months after study entry|Treated Population. Data are presented for only those participants who remained in the study during the indicated period and had their blood drawn for assessment.|||participants|||Number
1450308|NCT00849693|Secondary|Change From Week 10 in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 36 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS means are adjusted for baseline, pooled investigator, age category, visit, age category*visit and baseline*visit.|Week 10, Week 36|Participants with value during treatment phase and at least one post-Week 10 value.|||units on a scale||Standard Error|Least Squares Mean
1450309|NCT00849693|Primary|Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 10 Endpoint|CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) means are adjusted for baseline, pooled investigator, age category, visit, treatment, treatment*visit, age category*visit and baseline*visit.|Baseline, Week 10|Participants with both a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1450310|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen|"Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).~No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious."|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.||||||
1450311|NCT00849680|Primary|Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen|Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs).|4 weeks after booster injection|No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00849680) proved it was not efficacious.||||||
1450312|NCT00849680|Primary|Number of Participants With Laboratory Adverse Experiences|"Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.~All laboratory AEs were collected up to 29 days after any vaccine dose."|up to 260 weeks after first vaccination|Participants administered at least one dose of study vaccine. One participant who was lost to follow-up, and another one participant who discontinued as he comply with the protocol are not included.|||Participants|||Number
1450313|NCT00849680|Primary|Number of Participants With Adverse Experiences|"Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site AEs.~Systemic and Laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body.~Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose."|up to 260 weeks after first vaccination||||Participants|||Number
1450314|NCT00849524|Secondary|Determine Pharmacodynamic Parameters in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.||||||
1450315|NCT00849524|Secondary|Determine the Safety of Repeat Administration of Ad-ISF35 Injected Directly Into Lymph Nodes of Patients With CLL/SLL.||2 years (evaluation will be approx. 1 year per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.||||||
1450316|NCT00849524|Primary|Determine and Monitor Clinical and Biological Responses in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.||2 years (evaluation will be approx. 4 months per patient)|The study was not completed due to unavailability of the study drug, and therefore data were not collected for this Outcome Measure.||||||
1450317|NCT00849485|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1450318|NCT00849485|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg*h/mL||Standard Deviation|Mean
1450319|NCT00849485|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||mcg/mL||Standard Deviation|Mean
1450320|NCT00849472|Secondary|Number of Participants With Recurrence Events|The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population, excluding participants with recurrence before study entry|||participants|||Number
1450321|NCT00849472|Secondary|Number of Participants With the Indicated Radiotherapy-related Complications||up to 24 months after study entry|Treated Population|||participants|||Number
1450323|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry)|Treated Population: Only those members of the Treated Population who started the postoperative pazopanib period were assessed.|||Participants|||Number
1450324|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry).|Treated Population|||Participants|||Number
1450325|NCT00849472|Secondary|Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period|The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.|From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry)|Treated Population: all participants who entered the study and received at least one dose of any study medication|||Participants|||Number
1450326|NCT00849472|Secondary|Invasive Recurrence-free Interval (IRFI)|IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer [except LCIS] in the ipsilateral breast [IB]/skin of the breast), regional (development of tumor in the ipsilateral [IP] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.|up to 24 months after study entry|Evaulable Population. Participants with recurrence before study entry were excluded from analysis.|||months||95% Confidence Interval|Median
1450327|NCT00849472|Secondary|Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry)|Evaluable Population|||Participants|||Number
1450328|NCT00849472|Secondary|Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period|cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.|From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry|Evaluable Population|||Participants|||Number
1450329|NCT00849472|Secondary|Number of Participants With Pathologic Complete Response (pCR) in the Breast|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen.|From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry)|Evaluable Population|||Participants|||Number
1450330|NCT00849472|Primary|Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes|pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.|From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)|Evaluable Population: all participants who entered the study and received at least one dose of pazopanib.|||Participants|||Number
1450331|NCT00849381|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes|The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.|During the entire study period (up to Month 12)|The analysis was based on the subjects with positive pregnancy results in the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of Cervarix vaccine in this study and for whom data were available.|||Subjects|||Number
1450349|NCT00849147|Secondary|Donor Cell Engraftment|Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.|Measured at Day 56||||participants|||Number
1450350|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 50K|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
1450332|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|During the entire study period (up to Month 12)||||Subjects|||Number
1450333|NCT00849381|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Note: Results from one center where compliance issues were discovered are presented also separately."|During the entire study period (up to Month 12)||||Subjects|||Number
1450334|NCT00849290|Secondary|To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response||periodically over 24 months|||||||
1450335|NCT00849290|Primary|Safety of APC8015F by Review of Reported Adverse Events|All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.|periodically over 24 months|All participants who received at least one infusion of APC8015F|||participants|||Number
1450336|NCT00849251|Primary|Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1). [Dexamethasone MTD]|If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure will only describe the MTD for dexamethasone. Dexamethasone could not be reported with the MTD for the other three drugs due to a different Unit of Measure.|Up to 90 days after initiation of study treatment|Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that this Outcome Measure will only describe the MTD for dexamethasone. Dexamethasone could not be reported with the MTD for the other three drugs due to a different Unit of Measure.|||mg|||Number
1450337|NCT00849251|Primary|Disease Response Rate (Cohort II)|Disease response using Blade Multiple Myeloma Response Criteria in newly diagnosed (Cohort II) patients who completed at least one cycle of treatment. There were 24 evaluable patients in Cohort II.|up to 28 days after last cycle of treatment|Newly diagnosed patients (cohort II)|||Participants|||Count of Participants
1450338|NCT00849251|Primary|Maximum Tolerated Dose of This Combination of Drugs as Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Cohort 1) [MTD Cyclophosphamide, MTD Bortezmib, MTD Docxorubicin]|If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure shows MTD for cyclophosphamide, bortezomib and doxorubicin. MTD for dexamethasone is include in a separate table due to the different Unit of Measure.|Up to 90 days after initiation of study treatment|Patients with relapsed multiple myeloma who received cyclophosphomide, bortezomib, liposomal doxorubicin and dexamethasone. Note that the MTD for dexamethasone is in a separate table due to the different dosing unit.|||mg/m2|||Number
1450339|NCT00849212|Secondary|Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF|The percent change in seizure frequency per 28 days during the maintenance period was collected via patient diary cards. This was calculated using the last observation carried forward (LOCF) method.|Baseline (Day -28 to Day 0), Week 1 to Week 10|"Efficacy analysis set:~Population after excluding : (a) Patients who do not meet the inclusion criteria, (b) Patients who meet the exclusion criteria which affect efficacy evaluation of E2007, (c) Patients untreated,(d) Patients with no evaluable data on efficacy,(e) Patients with <80% treatment compliance"|||Percent change||Full Range|Median
1450340|NCT00849212|Primary|Maximum Tolerated Dose (MTD)|MTD was defined by participants. For participants who completed treatment, MTD was dose at last administration. For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration. If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.|10 weeks (Titration and Maintenance Periods)|Safety analysis set|||Participants|||Number
1450341|NCT00849186|Secondary|Response Rate After 90 Days of Treatment With SM||90 days|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
1450342|NCT00849186|Primary|Safety of Surgery After 90 Days of Treatment With SM|Incident Rate: Intraoperative Complication Rate|90 days|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
1450343|NCT00849186|Primary|Safety of Sunitinib Malate (SM)|Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.|90 days|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
1450344|NCT00849147|Secondary|Infections|Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.|Measured at Year 1|36 patients incurred a total number of 108 infection events.|||participants|||Number
1450345|NCT00849147|Secondary|Treatment-related Mortality (TRM)||Measured at 6 months and 1 year||||percentage of participants||95% Confidence Interval|Number
1450346|NCT00849147|Secondary|Progression-free Survival|Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, to death or to last follow-up.|Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
1450347|NCT00849147|Secondary|Chronic GVHD||Measured at Year 1||||percentage of participants||95% Confidence Interval|Number
1450348|NCT00849147|Secondary|Acute Graft-versus-host Disease (GVHD)||Measured at Day 100||||percentage of participants||95% Confidence Interval|Number
1450351|NCT00849147|Secondary|Platelet Recovery|Platelet Recovery to 20K|Measured at Days 56, 90, and 100||||percentage of participants||95% Confidence Interval|Number
1450356|NCT00849121|Secondary|The Number of Participants Who Are Metastasis-free at One Year.|The number of subjects who are metastatic-free at one year after starting study treatment will be tabulated for each arm. CT Scans and Bone Scans will be obtained at one year to determine whether metastatic disease is present.|one year from study entry||||participants|||Number
1450357|NCT00849121|Secondary|The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period.|The number of subjects who experience at least a two-fold increase in the PSA doubling time will be documented for each study arm. The PSA doubling time will be calculated using all PSA values obtained starting on Treatment Day 0 and continuing to end of treatment period and compared to the PSA doubling time collected at study entry prior to beginning study treatment.|Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years||||participants|||Number
1450358|NCT00849121|Primary|Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline.|The number of patients with a T-cell immune response will be determined for each study arm. An immune response will be defined as a PAP-specific T-cell frequency or proliferation index at 1 year that is at least 3-fold higher than the baseline T-cell frequency or proliferation index.|Baseline and 1 year.||||participants|||Number
1450359|NCT00849121|Primary|Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment.|The number and severity of toxicity incidents occurring between the pre-treatment and the final off-study evaluation will be collected and assigned an attribution. The toxicities observed will be summarized in terms of types and severities by the NCI Common Terminology Criteria version 3 for each study arm. The number of subjects experiencing grade 2 or higher autoimmune events or grade 3 or higher toxicities felt to be at least possibly related to pTVG-HP with GM-CSF study treatment will be compared between the two arms.|From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years||||participants|||Number
1450360|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by specificity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing Visit|intent to treat, received at least one dose of BMS747158|||Proportion of True Negative Cases|||Number
1450361|NCT00849108|Primary|Cohort 1: Determination of Ratio of Stress Dose to Rest Dose|The stress flurpiridaz dose for subsequent same-day rest-stress efficacy studies was determined as a multiple of the rest dose by computer modeling. Images derived only from rest flurpiridaz administration were blended using image analysis with images derived only from administration of flurpiridaz following exercise or adenosine stress. The blending fraction that resulted in negligible change in reader interpretation of defect severity was determined for each subject. The minimum value that met this criterion for all subjects was used to calculate the ratio of the stress dose to the rest dose as a function of the delay between administration of the two doses for both adenosine stress and exercise stress separately. No statistical analysis was performed.|Dosing visit|Subjects with demonstrated partially or completely reversible defects on prior SPECT who received at least one stress and one rest dose of flurpiridaz F 18, on separate days.|||Fraction of rest added to stress image|||Number
1450362|NCT00849108|Primary|Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity|Diagnostic efficacy of one-day rest/stress BMS747158 PET MPI is measured by sensitivity as compared to single photon emission computed tomography (SPECT)MPI in the detection of coronary artery disease (CAD)using angiography or three-month cardiac events as the truth standard.|Dosing visit|intent to treat, received at least one dose of BMS747158|||Proportion of True Positive Cases|||Number
1450363|NCT00849108|Primary|Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product|The rest flurpiridaz dose to be used for subsequent efficacy studies was determined by a modeling method that simulated a range of injected doses using a single fixed injected dose at rest in each subject and a range of acquisition durations. From this, a dose acquisition time product (DATP was determined for each subject that specified the minimal dose for a given acquisition duration that yielded an image in that subject that was negligibly affected by photon counting statistics. Descriptive statistics were used to identify an appropriate rest dose for the population. No other statistical tests were performed|Dosing visit|Intent to treat, received at least one rest dose of BMS 747158|||MBq X Minutes||Standard Deviation|Mean
1450364|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Kilograms||Standard Deviation|Mean
1450365|NCT00849056|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
1450366|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
1451560|NCT00841776|Secondary|Median Change in Noninflammaotry Acne Counts|Median Change in Noninflammaotry Acne Counts|Baseline, Weeks 2, 4, 8, 12, and 16||||Noninflammatory lesion counts||Inter-Quartile Range|Median
1450367|NCT00849056|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Participants|||Number
1450368|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1450369|NCT00849056|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1450370|NCT00849056|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
1450371|NCT00849056|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1450372|NCT00849056|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles).|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1450373|NCT00849017|Secondary|Albiglutide Plasma Concentration at Weeks 8 and 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post dose, Week 24 pre-dose and Week 24 post-dose. All participants who received albiglutide were initiated on a 30mg weekly dosing regimen; however, beginning at Week 12, participants in the albiglutide 50 mg treatment group were uptitrated to receive albiglutide 50 mg for the remainder of the study.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
1450374|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameters analyzed were: 4-hour insulin AUC (4 hr Ins AUC), and 4-hour proinsulin AUC (4 hr pro-Ins AUC). The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participant who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameters of insulin, proinsulin. The MM tolerance test was performed only in those participants who additionally consented to participate in.|||picomoles/Liter (pmol/L)||Standard Error|Least Squares Mean
1450375|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was: 4 hour blood glucose area under urve AUC The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of glucose. The MM tolerance test was performed only in those participants who additionally consented to participate in.|||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
1450376|NCT00849017|Secondary|Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC|Changes from Baseline at Week 52 in postprandial parameters after a mixed-meal (MM) tolerance test were analyzed. Post prandial blood glucose parameter analyzed was 4 hour c-peptide AUC. The AUC was determined using the trapezoidal method using measurements until 4 hours following the meal. The standardized AUC is the total AUC divided by elapsed time. Those parameters were analyzed analogous to the primary endpoint using an ANCOVA model with treatment group as a factor, and corresponding Baseline postprandial profile as a continuous covariate. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 52|MM Population: all participants who participated in the MM tolerance test substudy and who had valid Baseline assessments and Week 52 assessments for at least 1 of the MM lab parameter of C-peptide.|||Nanomoles/Liter (nmol/L)||Standard Error|Least Squares Mean
1450377|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Kilograms||Standard Deviation|Mean
1450378|NCT00849017|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
1450379|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
1450380|NCT00849017|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Participants|||Number
1450381|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1450382|NCT00849017|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1450383|NCT00849017|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|IIT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
1450384|NCT00849017|Secondary|Change From Baseline in HbA1c at Weeks 104 and 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Weeks 104 and 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1450385|NCT00849017|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1450386|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: 18S, B-actin, DUSP_1_T1, FKBP5, GAPDH, GILZ, PLAU, PTGS2, and RGS2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for 7 steroid-responsive genes (DUSP_1_TI, FKBP5, GILZ, PLAU, CCL2, PTGS2, and RGS2) and 3 housekeeping reference genes (GAPDH, 18S, and b-actin). Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented are an average of the data collected on Day 1 and Day 8 of each treatment period. Only those participants contributing data at the indicated time points were analyzed.|||RNA copies detected per 50 ng total RNA||95% Confidence Interval|Geometric Mean
1450387|NCT00848965|Secondary|Glucocorticoid (GC) Receptor Biomarker Levels in Nasal Epithelial Scraping Samples: CCL2|AROS Applied Biotechnology (AB) analyzed the nasal epithelial scrapings of participants and generated TaqMan (type of chemistry developed by AB to detect polymerase chain reaction [PCR] products) messenger ribonucleic acid (mRNA) biomarker expression data for CCL2, a steroid-responsive gene. Preliminary analysis of the mRNA abundance data was performed by Discovery Statistics. mRNA abundance data were normalized to the scores of GAPDH and 18S housekeeping genes. B-actin was not used. CCL2 data are presented by period to show the treatment-by-period interaction. ng, nanograms.|Day 1 (pre-dose) and Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. The data presented for each period are an average of the data collected on Day 1 and Day 8 of each period. Only those participants contributing data at the indicated time points were analyzed.|||Copies of RNA detected per 50ng of total||95% Confidence Interval|Geometric Mean
1450388|NCT00848965|Secondary|Weighted Mean Global Symptom Score (GSS) at 5 Hours Post-dose (1-4 Hours Post-start of Challenge)|GSS (total score=0-30) is calculated as the sum of sneeze, nasal itch, rhinorrhea, nasal obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes, and red eyes SSs, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), as was measured at pre-challenge, and then every 15 mins from 0.25 to 4 hours post-start of challenge chamber. Weighted mean global symptom score was evaluated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1450389|NCT00848965|Secondary|Weighted Mean Eye Symptom Score at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|The eye symptom score (total score of 0 [none] to 9 [severe]) was calculated as the sum of the symptom scores for watery eyes, itchy eyes, and red eyes, each of which was scored on a categorical scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), and was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours post-start of challenge chamber. Weighted mean eye symptom score was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1450390|NCT00848965|Secondary|Weighted Mean Nasal Secretion at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Nasal secretion was measured by weighing tissues used by participants. Wet tissue weight assessments were made pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of challenge chamber throughout the study. Weighted mean nasal secretion was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||grams (g)||Standard Deviation|Mean
1450409|NCT00848744|Primary|Physician Global Assessment|Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).|28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).|Analysis was per protocol. Each subject received formulations A and B randomized to opposite sides of the face.|||units on a scale||Standard Deviation|Mean
1450391|NCT00848965|Secondary|Weighted Mean Nasal Airflow at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge)|Allergic rhinitis decreases the passage of air through the nose (nasal airflow) by increasing the nasal airway resistance. Rhinomanometry is used as an objective measurement of airway resistance. Nasal airflow was measured using active anterior rhinomanometry at pre-challenge, and then every 30 minutes from 0.5 to 4 hours post start of VCC. Weighted mean nasal airflow was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population. Only those participants contributing data at the indicated time points were analyzed.|||Milliliters per second (mL/s)||Standard Deviation|Mean
1450392|NCT00848965|Primary|Weighted Mean Total Nasal Symptom Score (TNSS) at 2-5 Hours Post-dose (1-4 Hours Post-start of Challenge [PSC]) in the Vienna Challenge Chamber (VCC)|The TNSS (score of 0-12), defined as the sum of the symptom scores for nasal obstruction, rhinorrhea, nasal itch, and sneeze (each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]) was measured at pre-challenge, and then every 15 minutes from 0.25 to 4 hours PSC. In the VCC, aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve between 1 and 4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each study period (Periods 1-4); up to Day 158|All Subjects Population: all participants randomized to receive at least one dose of study treatment. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1450393|NCT00848926|Secondary|Time of Maximum Serum Concentration|Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||days||Full Range|Median
1450394|NCT00848926|Secondary|Maximum Serum Concentration|Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
1450395|NCT00848926|Other Pre-specified|B Symptom Resolution|Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|up to 12 months|Participants with B symptoms at baseline|||percent of participants||95% Confidence Interval|Number
1450396|NCT00848926|Secondary|Area Under the Curve|Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All participants who received treatment|||day * microgram/mL||Geometric Coefficient of Variation|Geometric Mean
1450397|NCT00848926|Secondary|Chemistry Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
1450398|NCT00848926|Secondary|Hematology Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.|up to 12 months|All participants who received treatment|||participants|||Number
1450399|NCT00848926|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|up to 12 months|All participants who received treatment|||participants|||Number
1450400|NCT00848926|Secondary|Overall Survival|Time from start of study treatment to date of death due to any cause.|up to approximately 6 years|Intention to treat|||months||95% Confidence Interval|Median
1450401|NCT00848926|Secondary|Progression-free Survival by Kaplan-Meier Analysis|Time from start of study treatment to disease progression per independent review group or death due to any cause.|up to approximately 4 years|Intention to treat|||months||95% Confidence Interval|Median
1450402|NCT00848926|Secondary|Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis|Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.|up to approximately 4 years|Participants with complete remission among the intention to treat population|||months||95% Confidence Interval|Median
1450403|NCT00848926|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.|up to approximately 4 years|Participants with objective response among the intention to treat population|||months||95% Confidence Interval|Median
1450404|NCT00848926|Secondary|Complete Remission Rate by Independent Review Group|Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
1450405|NCT00848926|Primary|Objective Response Rate by Independent Review Group|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|up to 12 months|Intention to treat|||percent of participants||95% Confidence Interval|Number
1450406|NCT00848783|Secondary|Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients|Secondary outcome measure was not analyzed as study was terminated|every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years|Secondary outcome measure was not analyzed as study was terminated||||||
1450407|NCT00848783|Primary|Number of Patients With One-year Recurrence-free Survival|This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.|1 year|Based on intent-to-treat population.|||participants|||Number
1450410|NCT00848549|Secondary|Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit|The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.|Weeks 0, 26, 52, 78 and 117|ITT Population|||Score on a scale||Standard Deviation|Mean
1450411|NCT00848549|Secondary|Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase|The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.|Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)|310 ITT Population|||Percentage of Participants||95% Confidence Interval|Number
1450412|NCT00848549|Secondary|Time to Drop-out Due to Adverse Event (AE)|"Adverse events in study subjects included any change in the subject’s condition.~This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF)."|Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)|310 ITT Population (33 participants were discontinued in the Zonisamide arm and 35 were discontinued in the Carbamazepine arm; these were the participants evaluated for this outcome)|||Days||Standard Deviation|Mean
1450413|NCT00848549|Secondary|Time to Drop-out Due to Lack of Efficacy|Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.|Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)|310 ITT Population (combined ITT Population from basecore study and extension phase). 24 participants were discontinued in each arm due to lack of efficacy; these were the participants that were evaluated in this outcome.|||Days||Standard Deviation|Mean
1450414|NCT00848549|Primary|Percentage of Participants Remaining in the Study at Each Visit|The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.|At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months|The Intent-to-Treat (ITT) Population is defined as all subjects who received at least one dose of investigational product(IP)|||Percentage of Participants||95% Confidence Interval|Number
1450415|NCT00848536|Primary|Mean Intraocular Pressure at 4:00 pm|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 4:00 pm)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.|||mmHg||Standard Error|Least Squares Mean
1450416|NCT00848536|Primary|Mean Intraocular Pressure at 11:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 11:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.|||mmHg||Standard Error|Least Squares Mean
1450417|NCT00848536|Primary|Mean Intraocular Pressure at 9:00 am|"For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient’s eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg~All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.~Mean IOP for the patient’s worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis"|3 months (measured at 9:00 am)|Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.|||mmHg||Standard Error|Least Squares Mean
1450418|NCT00848510|Secondary|Progression-Free Survival (PFS) Time|PFS was defined as the time from first study drug intake until radiological progression (based on RECIST Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Subjects without event were censored on the date of last tumor assessment. Investigator read was the assessment of all imaging by the treating physician at the local trial site.|Time from first study drug intake to disease progression, death or last tumor assessment until end of trial visit (4 weeks after last dose administration)|The safety analysis set included all subjects who received at least one dose of IMP administration.|||months||Full Range|Median
1450419|NCT00848510|Primary|Whole Tumor Volume and Enhancing Tumor Volume|Tumor volume (three-dimensional measurement) and the enhancing fraction of the tumor, which provides a gross measure of the proportion of the tumor that has a measurable level of perfusion, were assessed using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
1451561|NCT00841776|Secondary|Median Change in Inflammatory Acne Lesion Counts|Median Change in Inflammatory Acne Lesion Counts|Baseline, Weeks 2, 4, 8, 12, and 16|ITT|||Lesion Counts||Inter-Quartile Range|Median
1450420|NCT00848510|Primary|Initial Area Under the DCE-MRI Contrast Agent Concentration Time Curve After 60 Seconds (IAUC60)|IAUC 60 was used to give a gross indication of the delivery and uptake of contrast agent within the tumor (indicating the degree of perfusion and endothelial permeability. IAUC60 was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||(Millimoles/liter)*sec||Standard Deviation|Mean
1450421|NCT00848510|Primary|Blood Plasma Volume and Extravascular/Extracellular Volume|Blood plasma volume and extracellular/extravascular volume was measured using DCE-MRI.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||milliliter||Standard Deviation|Mean
1450422|NCT00848510|Secondary|Number of Subjects With Positive Binding Abituzumab Antibodies|Subjects were defined as abituzumab positive if at least one positive result of antibodies against abituzumab was observed. In all other cases, subjects were defined as abituzumab negative.|Day 1 of Weeks 1, 3, 5, 6, 7, 8, and week 11 and end of study (EOS) visit (4 weeks after last dose administration)|"The immunogenicity analysis set included all subjects who received at least one dose of study drug administration and provided sufficient data from the antibodies samples. 'N' (number of subjects analyzed) signifies the subjects evaluable for this outcome measure. n signifies the number of subjects evaluable for each time point, respectively."|||Subjects|||Number
1450423|NCT00848510|Secondary|Number of Subjects With Worsened Post Baseline Shift in ECOG Performance Status Score|The number of subjects who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment. The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.|Up to 4 weeks after last dose administration|The safety analysis set included all subjects who received at least one dose of IMP administration.|||Subjects|||Number
1450424|NCT00848510|Secondary|Number of Subjects With Best Overall Response, Tumor Response and Clinical Benefit|Tumor response was assessed by the Investigator, based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria. Tumor response was defined as the presence of a “best overall response” of complete response (CR) or partial response (PR). CR: Disappearance of all target and non-target lesions and/or normalization of serum levels of tumor markers. PR: At least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD of target lesions. The qualification of a CR or of a PR needed a confirmation by a second computed tomography (CT) scan at least 4 weeks after the first scan. Best overall response was derived programmatically as the best response recorded from the first investigation medicinal product administration until disease progression. Clinical benefit was defined as the presence of a “best overall response” of complete response or partial response or stable disease lasting at least 6 weeks.|Up to 4 years|The full analysis set included all subjects who received at least one dose of IMP administration. “N” signifies the total number of participants evaluable for this outcome measure. Same subjects may be reported in more than one category.|||Subjects|||Number
1450425|NCT00848510|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the initiation of the trial treatment until 30 days after last administration of trial treatment.|The safety analysis set included all subjects who received at least one dose of IMP administration.|||Subjects|||Number
1450426|NCT00848510|Primary|Volume Transfer Coefficient of Contrast Agent Across the Capillary Walls|Volume transfer coefficient was defined as the volume transfer coefficient of contrast agent across the capillary wall, reflecting endothelial permeability and blood flow. Volumetric transfer coefficient was measured by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). DCE-MRI is a noninvasive quantitative method of investigating microvascular structure and function by tracking the pharmacokinetics of injected low molecular weight contrast agents as they pass through tumor vasculature.|Screening 1, screening 2, Week 1 Day 2, Week 1 Day 5, and Week 2 Day 1|The DCE-MRI analysis set included all subjects who had at least one valid predose scan and at least one valid postdose (that is, after the infusion) scan.|||min^-1||Standard Deviation|Mean
1450427|NCT00848510|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|Toxicity was graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. A DLT was defined as any Grade 3 or 4 haematological or non-haematological toxicity occurring during the first 4 weeks of treatment (that is, until the beginning of Week 5, with the exception of Grade 3 asymptomatic increase in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase [ALP]) returning to Baseline within 7 days.), at any dose level, for which a causal relationship to the investigative medicinal product could not be ruled out by the Investigator and/or the Sponsor.|Up to Week 4|Dose escalation analysis set included all subjects in the safety analysis set who experienced any DLT during the DLT observation period, regardless of the number of investigational medicinal product (IMP) administrations and subjects who received the IMP at Weeks 1, 3, and 5 for Cohort 1 and at Weeks 1 and 3 for all other cohorts.|||Subjects|||Number
1450428|NCT00848497|Secondary|Change in the EPIC (Expanded Prostate Cancer Index Composite) Score 6 Months After the Initial Screening Visit.|EPIC is scored from 0 -100,lower EPIC score= worse, higher EPIC score= better|Basline and 6 months|"Baseline = 98~5 months = 87"|||units on a scale|||Number
1450429|NCT00848497|Secondary|Change in the ADAM (Androgen Deficiency in the Aging Male)Score 6 Months After the Initial Screening Visit.|ADAM scores of one evaluated patient. ADAM is 10 questions (“yes” or “no” answers) and if you answer yes to question 1 or 7 or “yes” to any 3 questions you are said to test “positive” to the ADAM questionnaire.|Baseline and 6 months|Baseline = Positive 5 months = Positive|||number of yes answers|||Number
1450430|NCT00848497|Secondary|Change in the IIEF (International Index of Erectile Function) Score 6 Months After the Initial Screening Visit.|There are 15 questions, each divided into 5 domains. Maximum score is 75 = best function, and minimum is 5 = worst function|Baseline and 6 months|Baseline = 5 5 months = 6|||units on a scale|||Number
1450431|NCT00848497|Primary|Change in SHIM (Sexual Health Inventory for Males) Score at 6 Months After Initial Screening Visit.|SHIM range is 0-25. 0= no sexual activity;1-7 severe ED; 8-11 Moderate ED; 12-16 Mild to Moderate ED; 17-21 Mild ED|Baseline and 6 months|Baseline = 0 5 months = 0|||units on a scale|||Number
1450432|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score|The Attention/Processing Speed Composite Score was comprised of the following tests: Identification Task and the Detection Task from the CogState Schizophrenia Battery and the Symbol Coding test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -287.15 and 287.15, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
1450433|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score|The Working Memory Composite Score was comprised of the following tests: Two-Back Memory Task from the CogState Schizophrenia Battery and the Digit Sequencing test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -27.06 and 27.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
1450434|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score|The Episodic Memory Composite Score was comprised of the following tests: Continuous Paired Associate Learning Task and One Card Learning Task from the CogState Schizophrenia Battery and the Verbal Memory test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -207.06 and 207.06, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
1450435|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score|The Executive Functioning Composite Score was comprised of the following tests: Groton Maze Learning Task from the CogState Schizophrenia Battery and Tower of London, Semantic Fluency and Letter Fluency tests from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -253.4 and 253.4, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
1450436|NCT00848484|Secondary|Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score|CogState Schizophrenia Battery was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The composite score was comprised of 4 modules from the CogState Schizophrenia Battery: Identification Task, Detection Task, One Card Learning Task and Groton Maze Learning Task. Composite score was calculated by averaging all available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at 2 weeks of treatment for the endpoint are -347.5 and 347.5, respectively.|Baseline and week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
1450437|NCT00848484|Primary|Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment|The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively.|Baseline and Week 2|Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods.|||T-score based on normative data||95% Confidence Interval|Least Squares Mean
1450448|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450438|NCT00848393|Secondary|ABAS-II|The ABAS–II is designed to evaluate whether an individual displays various functional skills necessary for daily living without the assistance of others. Thus, this instrument focuses on independent behaviors and measures what an individual actually does, in addition to measuring what he or she may be able to do. In addition, the ABAS–II focuses on behaviors an individual displays on his or her own, without assistance from others. The Parent/Primary Caregiver Form is a comprehensive, diagnostic measure of the adaptive skills that have primary relevance for the functioning of infants, toddlers, and preschoolers in the home and other settings, and can be completed by parents or other primary care providers. Each composite or domain score is determined by summing the appropriate scaled scores and then determining its equivalent composite or domain score by looking it up in a table located in the manual.The range for all scores is 50-150, with a higher score equaling a better outcome.|1-4 yrs post-surgery|Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.|||units on a scale||Standard Deviation|Mean
1450439|NCT00848393|Secondary|Stanford-Binet Cognitive Ability|The Stanford–Binet Intelligence Scale is now in its fifth edition (SB5) and was released in 2003. It is a cognitive ability and intelligence test that is used to diagnose developmental or intellectual deficiencies in young children. The test measures five weighted factors and consists of both verbal and nonverbal subtests. The five factors being tested are knowledge, quantitative reasoning, visual-spatial processing, working memory, and fluid reasoning. Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150). Higher scores suggest a higher level of functioning related to each category.|1-4 yrs post-surgery|Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.|||units on a scale||Standard Deviation|Mean
1450440|NCT00848393|Primary|Stress Hormone Levels|Cortisol, epinephrine, and norepinephrine assayed by enzyme-linked immunosorbent assay (ELISA).|Blood draws to measure stress hormone levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.||||ng/mL||Standard Deviation|Mean
1450441|NCT00848393|Primary|Stanford-Binet Intelligence Scales|The Stanford-Binet test evaluates the overall IQ score from the assessment of cognitive ability. The test consists of 15 subtests, grouped into the four area scores. Six subtests are administered to all age levels. The subtests are: Vocabulary, Comprehension, Pattern Analysis, Quantitative, Bead Memory, and Memory for Sentences. Number of tests administered and test difficulty are based on the test taker's age and performance on subtest measuring word knowledge. The word knowledge subtest is given to all test takers and is the first subtest administered. A score of 100 is in the normal or average range. Higher scores suggest a higher level of functioning related to each category. (University of Cincinnati, 2003) Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150).|1-4 yrs. post-surgery|Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients.|||IQ||Standard Deviation|Mean
1450442|NCT00848393|Primary|Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator.||Time of intubation to extubation (variable)||||Hours||Full Range|Median
1450443|NCT00848393|Primary|Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay.||Hospital admission to discharge from CTICU (average of 2-4 days)||||Days||Full Range|Median
1450444|NCT00848393|Primary|ACTH and Cytokine Levels|N = 48 n = 16 (LDF); n = 17 (HDF); n = 15 (LDF + Dex) ACTH assayed by enzyme-linked immunosorbent assay (ELISA); Cytokine levels in plasma were measured using the Immulite automated chemiluminometer. Measured cytokines include interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-α.|Blood draws to measure cytokines levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure.||||pg/mL||Standard Deviation|Mean
1450445|NCT00848367|Secondary|Depression Symptoms|Early response to treatment is indicated by a reduction in depression symptoms measured by The Beck Depression Inventory II (BDI-II; Beck, Steer, & Brown, 1996). The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The range for this scale is 0-63. Higher scores represent more depressive symptoms. We included cases that were missing up to 8 missing items and calculated scores for participants with missing items by taking the weighted mean and multiplying by 21.|Pre and Post treatment, 6 months and 1 year||||units on a scale||Standard Deviation|Mean
1450446|NCT00848367|Primary|Frequency of Binge Eating in the Past 28 Days||Pre and Post treatment, 6 months and 1 year||||days||Standard Deviation|Mean
1450447|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450553|NCT00848120|Secondary|Time to Onset of ACR20/50/70 Response|Time to onset of ACR 20/50/70 response was calculated as the number of weeks from the administration of the first dose of study drug until the date of first achievement of ACR 20/50/70 per criteria.|Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||weeks||Inter-Quartile Range|Median
1450449|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450450|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450451|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450452|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450453|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450454|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450455|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1451331|NCT00843479|Primary|Glucose Infusion Rate|Whole-body insulin sensitivity, as estimated by the mean glucose infusion rate corrected for fat-free mass(FFM){mg*[kg(FFM)^-1]*min*10} at last 60 min of 180-min hyperglycemic clamp|within 1 month from screening visit||||mg*[kg(FFM)^-1]*min*10||Standard Deviation|Mean
1450456|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450457|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450458|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 50, Week 76, Week 102, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450459|NCT00848354|Secondary|Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Week 8, Week 16, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450460|NCT00848354|Secondary|Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mg / dL||Standard Error|Least Squares Mean
1450461|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm/hour||Standard Deviation|Mean
1450462|NCT00848354|Secondary|Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm/hour||Standard Error|Least Squares Mean
1450463|NCT00848354|Secondary|Change From Baseline in Erosion Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1451147|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to 48 Hours Post-dose (AUC48)|Geometric means of AUC48 = area under the plasma concentration-time profile from time zero (0) to 48 hours postdose of atorvastatin (test versus [vs] reference); measured in nanograms times hour per milliliter (ng.hr/mL).|5 days||||ng.h/mL||Full Range|Geometric Mean
1450464|NCT00848354|Secondary|Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24|mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Week 24|xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1450465|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm||Standard Deviation|Mean
1450466|NCT00848354|Secondary|Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm||Standard Error|Least Squares Mean
1450467|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm||Standard Deviation|Mean
1450468|NCT00848354|Secondary|Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm||Standard Error|Least Squares Mean
1450469|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||mm||Standard Deviation|Mean
1450470|NCT00848354|Secondary|Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||mm||Standard Error|Least Squares Mean
1450471|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||min||Standard Deviation|Mean
1450472|NCT00848354|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||min||Standard Error|Least Squares Mean
1450473|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450474|NCT00848354|Secondary|Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450613|NCT00847665|Primary|Incidence of Pressure Ulcer (PU) Grade ≥ II|Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer|Intensive Care Unit (ICU) length of stay (days)|Intention to treat|||participants|||Number
1450475|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450476|NCT00848354|Secondary|Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The participant`s global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450477|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450478|NCT00848354|Secondary|Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450479|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450480|NCT00848354|Secondary|Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450481|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450482|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450483|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450484|NCT00848354|Secondary|Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1451148|NCT00844298|Secondary|Overall Survival||2 years|||||||
1450485|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450486|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450487|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450488|NCT00848354|Secondary|Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS28<3.2: low disease activity, DAS28<2.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450489|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450490|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450491|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:~DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6~DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450492|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:~DAS28-value ≤5.1 and DAS28-improvement from Baseline >0.6~DAS28-value >5.1 and DAS28-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450493|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450744|NCT00847145|Secondary|The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).|one month after booster (fourth) vaccination.|This analysis was done on PP population.|||Titers||95% Confidence Interval|Geometric Mean
1450494|NCT00848354|Secondary|Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450495|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:~DAS-value ≤3.7 and DAS-improvement from Baseline >0.6~DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450496|NCT00848354|Secondary|Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|"DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:~DAS-value ≤3.7 and DAS-improvement from Baseline >0.6~DAS-value >3.7 and DAS-improvement from Baseline >1.2"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450497|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450498|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450499|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450500|NCT00848354|Secondary|Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450501|NCT00848354|Secondary|Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450502|NCT00848354|Secondary|Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS<2.4: low disease activity, DAS<1.6: remission.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450554|NCT00848120|Secondary|Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 >2.6 and <3.2=low disease activity.|Week 24|ITT Population|||percentage of participants|||Number
1450503|NCT00848354|Secondary|Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450504|NCT00848354|Secondary|Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant`s general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS<1.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450505|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450506|NCT00848354|Secondary|Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450507|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450508|NCT00848354|Secondary|Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450509|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and ESR.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||percentage of participants|||Number
1450510|NCT00848354|Secondary|Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of HAQ); and CRP.|Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||percentage of participants|||Number
1450555|NCT00848120|Secondary|Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hour) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 <2.6=remission.|Week 24|ITT Population|||percentage of participants|||Number
1450511|NCT00848354|Secondary|Summary of Changes in Therapy at the Beginning of Phase 2|The investigators were allowed to alter each participant`s therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.|Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. One participant was randomized to etanercept but received SSZ in Phase 1.|||participants|||Number
1450512|NCT00848354|Secondary|Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant`s general health using a 100 mm-VAS. DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128|mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).|||units on a scale||Standard Deviation|Mean
1450513|NCT00848354|Secondary|Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant`s general health using a 100 mm-visual analog scale (VAS). DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
1450514|NCT00848354|Secondary|Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24|mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 24|Radiographic intent-to-treat (xITT) population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
1450515|NCT00848354|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24|The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores – physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||Units on a scale||Standard Error|Least Squares Mean
1450516|NCT00848354|Secondary|Change From Baseline in HAQ Score at Week 24|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.|Baseline and Week 24|mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.|||Units on a scale||Standard Error|Least Squares Mean
1450517|NCT00848354|Primary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24|ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).|Week 24|Modified intent-to-treat (mITT) population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. Last Observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
1450518|NCT00848250|Secondary|Postoperative Renal Function|Acute kidney injury occurring|Baseline (prior to surgery) to postoperative day 1||||Percentage of subject with AKI|||Number
1450519|NCT00848250|Secondary|Postoperative Bleeding|Chest tube output at 4 and 24 hours after completion of surgery|24 hours||||mL/kg||Standard Error|Mean
1450520|NCT00848250|Secondary|(MAP) Mean Arterial Blood Pressure||Baseline (prior to surgery) to postoperative day 1||||mmHg||Standard Error|Mean
1450521|NCT00848250|Secondary|IL-8 (Interleukin-8)||Baseline (pre-surgery) to postoperative day 1||||pg/mL||Standard Error|Mean
1450522|NCT00848250|Secondary|IL-6 (Interleukin-6)||Baseline (pre-surgery) to postoperative day 1||||pg/ml||Standard Error|Mean
1450523|NCT00848250|Primary|t-PA (Tissue-type Plasminogen Activator) Antigen||Baseline (prior to surgery) to postoperative day 1||||ng/ml||Standard Error|Mean
1450524|NCT00848250|Primary|(PAI-1) Plasminogen Activator Inhibitor -1 Antigen||Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1||||ng/ml||Standard Error|Mean
1450525|NCT00848237|Primary|Adverse Event Incidence|Adverse and Serious Adverse event with Definite device relationship|12 month||||participants|||Number
1450526|NCT00848237|Primary|Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month|Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).|12 month|943 subjects completed both baseline and follow up quality of life life survey|||units on a scale||Standard Deviation|Mean
1450527|NCT00848237|Primary|Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up|Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface|1 year||||percentage of patients with SSIM|||Number
1450528|NCT00848237|Primary|Histological Clearance Rate for Dysplasia (CE-D)|percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis|||percentage of participants|||Number
1450529|NCT00848237|Primary|Histological Clearance Rate for Intestinal Metaplasia (CE-IM)|Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up|1 year|4118 provided biopsies at least 1 year post RFA|||percentage of participants|||Number
1450530|NCT00848237|Primary|Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up|% of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.|1 year|4011 subjects provided the answers|||percentage of participants|||Number
1450531|NCT00848211|Primary|CD4+ T-cell Count|Change in CD4+ T-cell count from baseline|baseline and 20 weeks||||cells/mm3||Standard Error|Log Mean
1450532|NCT00848211|Secondary|Determination of Anti-Tat Antibodies|Determination of change in anti-Tat antibody level|baseline and 16 weeks||||ng/mL||Full Range|Median
1450533|NCT00848211|Primary|HIV Viral Load|Change in HIV viral load from baseline|baseline and 20 weeks||||HIV RNA copies/mL||Standard Error|Log Mean
1450534|NCT00848198|Secondary|Referent Values for Ocular Surface Disease Index|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment and the index is calculated based on the responses given by the subject. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. A score of 0 confirms no dry eye symptoms are present, while a maximum of 100 indicates the maximum severity of symptoms experienced by subjects.|Single visit||||Score||Standard Deviation|Mean
1450535|NCT00848198|Secondary|Referent Values for Meibomian Gland Grading|Meibomian gland dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A score of 0 indicates full integrity of these glands while the maximum of 27, is used for severe damage.|Single visit||||Grade||Standard Deviation|Mean
1450536|NCT00848198|Secondary|Referent Values for Conjunctival Staining|Conjunctival staining is used to identify and evaluate dead or injured conjunctival cells. Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. A score of 0 indicates no damage of conjunctival cells, while the maximum for the most severe damage is 12.|Single visit||||Grade||Standard Deviation|Mean
1450537|NCT00848198|Secondary|Referent Values for Corneal Staining|Corneal Staining is used to identify and evaluate ocular surface and corneal damages. It was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. A score of 0 indicates no damage of ocular surface/cornea, while the maximum for the most severe damage is 15.|Single visit||||Grade||Standard Deviation|Mean
1450538|NCT00848198|Secondary|Referent Values for Tear Film Breakup Time||Single visit||||seconds||Standard Deviation|Mean
1450539|NCT00848198|Secondary|Referent Values for Schirmer Test||Single visit||||mm||Standard Deviation|Mean
1450540|NCT00848198|Secondary|Referent Values for Tear Osmolarity||Single visit||||mOsm/L||Standard Deviation|Mean
1450541|NCT00848198|Primary|Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100|Ocular Surface Disease Index (OSDI) Questionnaire was used for symptoms assessment. A cutoff of 15/100 score was used to differentiate between normal and dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
1450542|NCT00848198|Primary|Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27|Meibomian dysfunction was assessed to grade the quality, expressibility, and volume of gland secretion, according to Bron/Foulks scoring system. A cutoff threshold of grade 5/27 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
1450580|NCT00847886|Secondary|Half-life of LX3305 in Plasma in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.|||hours||Standard Deviation|Mean
1451149|NCT00844298|Secondary|Disease(Relapse)-Free Survival||2 years|||||||
1450543|NCT00848198|Primary|Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12|Conjunctival staining was performed 2.5 to 3.0 minutes after instillation of 10 μL of a 1% sodium lissamine green dye. Conjunctival staining followed the National Eye Institute/Industry Workshop scale. A cutoff threshold of grade >3/12 was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
1450544|NCT00848198|Primary|Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15|Corneal Staining was evaluated under cobalt blue illumination 2.5 to 3.0 minutes after fluorescein instillation. Staining amplitude followed the National Eye Institute/Industry Workshop scale. The cutoff threshold >4/15 was used to differentiate normals from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
1450545|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds|Tear film breakup time was measured by instilling 5μL of a 2% sodium fluoresceine solution and calculating the average of three consecutive breakup times, manually determined with a stopwatch. The cutoff of <5 seconds was used to differentiate normal from dry eye subjects. The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, Meibomiann secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease).|Single visit||||participants|||Number
1450546|NCT00848198|Primary|Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm|"A 5-minute Schirmer test was performed with sterile strips without anesthetic (Tear Flo). The cutoff threshold of <7mm was used to differentiating normal from mild subjects.~The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test. To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit||||participants|||Number
1450547|NCT00848198|Primary|Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L|"Tear osmolarity was measured with a laboratory-on-a-chip, to simultaneously collect and analyze the electrical impedance of a 50 nL tear sample from the interior lateral meniscus (TearLab Osmolarity System). A cutoff threshold of more than 308 mOsm/L was used for differentiating normal from mild to moderate subjects.~The clinical tools most commonly used in grading dry eye severity are symptomatology (e.g. questionnaires such as the Ocular Surface Disease Index (OSDI) or McMonnies Dry Eye Questionnaire), tear osmolarity, tear film breakup time (TBUT), fluoresceine or lissamine green staining of the cornea and conjunctiva, meibomiam secretion scoring, and the Schirmer test.To convert all the various clinical measurements into a common unit system, based on their breakpoints provided by the Dry Eye Workshop (DEWS), a composite score was created. Its scale being between 0 (representing the least evidence of disease) and 1 (representing the most evidence of disease)."|Single visit||||participants|||Number
1450548|NCT00848185|Primary|VEGF Protein and mRNA Levels|VEGF concentration in follicular fluid and VEGF mRNA expression in granulosa cells from patients who received either GnRH agonist instead of hCG|1 year||||pg/ml||Standard Deviation|Mean
1450549|NCT00848172|Secondary|PK: AUC After OA|Area under the curve of PA plasma levels after administration|5 to 300 min post dose||||hr*ng/ml||Standard Deviation|Mean
1450550|NCT00848172|Secondary|TMax Octanoic Acid|Time to plasma peak OA|between 5 and 300 min post dose||||min||Standard Deviation|Mean
1450551|NCT00848172|Secondary|Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo|As described at the section for the primary outcome, normalized accelerometric tremor accelerometry was measured at other time-points to describe a time-course of effect. This stated secondary outcome compared normalized (baseline = 1) accelerometric at the last time-point 300 min post dose after OA vs Placebo. Ratios of tremor power at 300 min divided by tremor power at baseline used for outcome measure calculation.|300 min post dose||||ratio||Inter-Quartile Range|Median
1450552|NCT00848172|Primary|Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition|Postural tremor was measured using accelerometry with a motion sensor (accelerometer) placed at the dorsum of each hand, and tremor recorded simultaneously with surface-electromyography of wrist flexors and extensors for 2 minutes at each time-point. The recording was repeated with 1 lbs weight added to each wrist, which was described to record the central tremor component. The primary outcome measure was defined as tremor power of the central tremor component (after the addition of weight) 80 minutes after administration, measured at the dominant hand, normalized to baseline (baseline = 1), and comparing octanoic acid vs. placebo. Ratio of tremor power at 80 min divided by tremor power at baseline used for outcome measure calculation.|80 min after administration of the study drug on day 1 and 2 of Visit 2|2 patients were excluded from primary outcome measure analysis because of one subject was withdrawn prior to drug administration due to an SAE, and one subject did not exhibit a central tremor component (primary measure), on the day of administration.|||ratio||Inter-Quartile Range|Median
1450556|NCT00848120|Secondary|Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24|DAS28-ESR calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour [mm/hour]) and Patient's Global Assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1450557|NCT00848120|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participants response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the health status.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1450558|NCT00848120|Secondary|HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24|HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To calculate HAQ-DI the participant must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst).|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1450559|NCT00848120|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population|||percentage of participants|||Number
1450560|NCT00848120|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (VAS), 4) participant assessment of functional disability via a HAQ, and 5) ESR at each visit.|Week 24|ITT Population|||percentage of participants|||Number
1450561|NCT00848120|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24|ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.|Week 24|ITT population|||percentage of participants|||Number
1450562|NCT00848107|Primary|Formation of New Ulcers|The number and percentage of subjects who developed new ulcers during the study were summarized.|18 months (or last study visit)|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||participants|||Number
1450563|NCT00848107|Primary|Total Ulcer Number- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|The total ulcer number includes all ulcers designated as “active”, “indeterminate”, or “new” for a given visit. The mean change in the total number of ulcers present from time of study entry was summarized for each scheduled visit assessment.|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||number of ulcers||Standard Deviation|Mean
1450564|NCT00848107|Secondary|Patient Function and Quality of Life Measure: Cochin Hand Function Scale (CHFS)-Mean Change From Study Entry in CHFS Score at Each Scheduled Assessment|The CHFS score is derived from 18 validated questions that assess functional disability and handicap due to hand involvement in rheumatoid arthritis. Each answer is scored on a scale with possible integer responses of 0(without difficulty) to 5 (impossible). The CHFS score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS score values can range from 0 (least limitation) to 90 (most limitation), with improvements in function or reduction of limitation indicated a decreased score value. The mean change from study entry in CHFS scores at each scheduled assessment are summarized.|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||units on a scale||Standard Deviation|Mean
1450565|NCT00848107|Primary|Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit Assessment|Net ulcer burden at any given assessment was defined as the number of “new” or “active” ulcers at that assessment, plus the number of “indeterminate” ulcers at that assessment that had previously been classified as either “active” or “new” at any earlier assessment during the study. The mean change in net ulcer burden from time of study entry was summarized for each scheduled visit assessment.|Baseline and Months 1, 3, 6, 9, 12, and 18|Efficacy was assessed using data obtained at each visit, if available, from all subjects enrolled in this study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||ulcers||Standard Deviation|Mean
1450581|NCT00847886|Secondary|Time to Maximum Plasma Concentration of LX3305 in the Presence of MTX||Day 15|This outcome was not measured in the Methotrexate + LX3305 placebo subjects.|||hours||Full Range|Median
1450566|NCT00848107|Secondary|Patient Function and QOL Measure: Scleroderma Health Assessments Questionnaire (SHAQ)- Mean Change From Study Entry in SHAQ Component Scores at Each Scheduled Assessment|The SHAQ consists of 20 health assessment questionnaire questions with integer responses of 0 (without any difficulty) to 3 (unable to do), and five scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud’s Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with values ranging from 0.0 to 15.0 centimeters. The questions are divided into eight component domains: Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each domain score is calculated by summing the domain responses and dividing by the number of questions in that domain. Each VAS domain score is calculated by dividing the value in centimeters by 5. SHAQ component and VAS domain score ranges from 0 (least limitation) to 3 (most limitation). The aggregate SHAQ score is calculated by dividing the sum of all domain scores by 13, with a score ranging from 0 (least limitation) to 3 (most limitation).|Baseline and Months 1, 3, 6, and 12|Efficacy was assessed by the change in net ulcer burden and in the total ulcer number from Baseline at each of the follow-up visits and the percentage of subjects with formation of new ulcers during the study. Assessments performed after discontinuation of study drug were excluded from the summaries.|||units on a scale||Standard Deviation|Mean
1450567|NCT00848081|Secondary|Uroflowmetry (Qmax) Change From Baseline|Change from baseline to endpoint in Qmax. Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).|Baseline, 12 Weeks|All randomized subjects with non-missing data.|||milliliters per second||Standard Deviation|Mean
1450568|NCT00848081|Secondary|Postvoid Residual Volume (PVR) Change From Baseline|Change from baseline to endpoint in PVR volume. PVR is obtained by measuring with ultrasound the remaining urine in the bladder after urination.|Baseline, 12 Weeks|All randomized subjects who had non-missing baseline and endpoint data.|||milliliters||Standard Deviation|Mean
1450569|NCT00848081|Secondary|International Prostate Symptom Score (IPSS) Change From Baseline|Change from baseline to endpoint in IPSS Score. The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication and had non-missing baseline and endpoint data.|||units on a scale||Standard Deviation|Mean
1450570|NCT00848081|Secondary|Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit|A positive orthostatic test is defined as at least one of the following 4 criteria being met at any pre-randomization or post-randomization visit: (1) reduction in systolic blood pressure of >= 20 mmHg from the supine to standing position;(2)reduction in diastolic blood pressure of >=10 mmHg from the supine to standing position;(3)increase in heart rate of >= 20 bpm from the supine to standing position; or (4)Unable to remain standing. A negative orthostatic test is defined as none of the above 4 criteria (1, 2, 3, or 4) being met at any pre-randomization or post-randomization visit.|Baseline through 12 Weeks|All randomized subjects in the analysis population with non-missing data.|||Participants|||Number
1450571|NCT00848081|Primary|Number of Men With Treatment-emergent Dizziness|The primary safety measure is the proportion (reported in numbers) of subjects experiencing treatment-emergent dizziness to include the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms of dizziness, dizziness postural, and procedural dizziness. Treatment-emergent dizziness is defined as any of the predefined terms of dizziness that is first reported or worsens in severity after baseline.|Baseline through 12 Weeks|Primary Analysis Population-included all subjects who were randomized and took at least one dose of study medication.|||Participants|||Number
1450572|NCT00848042|Secondary|Response in Targeted Tumors.||6 months|Data was not collected/analyzed||||||
1450573|NCT00848042|Primary|Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration|Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion|up to 6 months|per protocol|||participants|||Number
1450574|NCT00848016|Secondary|Progression-free Survival|The progression-free survival is defined as the time from registration to the date of progression or death, whichever comes first. The distributions of progression-free survival time will be estimated using the method of Kaplan-Meier.|From registration to progression or death, whichever occurs first, up to 2 years.||||months||95% Confidence Interval|Number
1450575|NCT00848016|Secondary|Overall Survival|The overall survival time is defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|From registration to date of last follow-up or death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
1450576|NCT00848016|Primary|The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria|"In order for a patient to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart. The proportion of patients who achieve a confirmed objective response to treatment will be estimated by the standard binomial estimator, i.e., the number of successes divided by the total number of evaluable patients.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD."|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
1450577|NCT00847912|Primary|Hazard Ratio for Surgically Treated KC||date of randomization to last visit before end of study follow up (6/30/2013), assessed up to four years||||participants|||Number
1450578|NCT00847912|Primary|The Time to Diagnosis of the First Keratinocyte Carcinoma (KC) on the Face or Ears for Which Surgery is Performed|Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.|From randomization to last visit prior to end of study date (6/30/2013), assessed up to four years||||years||95% Confidence Interval|Median
1450579|NCT00847886|Secondary|Percentage of Change From Baseline in Absolute Total Lymphocyte Count at Day 15|Baseline was defined as pre-dose on Day 1.|Day 15||||Percent||Standard Deviation|Mean
1450590|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450591|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450592|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450593|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450594|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450595|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450596|NCT00847808|Secondary|Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.|PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450597|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450673|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
1450598|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450599|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450600|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450601|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450602|NCT00847808|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.|PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.|Baseline and Week 6.|Values are from the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
1450603|NCT00847808|Primary|Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.|Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period.|Week 3 through Week 6|Values are from the Full Analysis Set.|||percent of participants|||Number
1450604|NCT00847704|Secondary|Active Motion Test|Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)||||Seconds||Standard Deviation|Mean
1450605|NCT00847704|Secondary|Strength Test|Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).|First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)||||Newton meters||Standard Deviation|Mean
1450606|NCT00847704|Secondary|Spasticity (Modified Ashworth) Scale|Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||units on a scale||Standard Deviation|Mean
1450607|NCT00847704|Secondary|Stroke Impact Scale|"The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows:~Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100.~Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning."|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||units on a scale||Standard Deviation|Mean
1450608|NCT00847704|Secondary|Timed 10-Meter Walk|Gait Assessment - Time|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||seconds||Standard Deviation|Mean
1450609|NCT00847704|Primary|Fugl-Meyer Assessment of the Lower Extremity|Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.|Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up||||units on a scale||Standard Deviation|Mean
1450610|NCT00847665|Secondary|Length of Mechanical Ventilation (MV)|Time from initiation to withdrawal of mechanical ventilation. Days|ICU length of stay||||days||Inter-Quartile Range|Median
1450614|NCT00847626|Secondary|Percentage of Participants Who Achieve Both a Clinic Systolic and Diastolic Blood Pressure Response at Week 8.|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at week 8, defined as systolic blood pressure less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg AND diastolic blood pressure less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg . Systolic/diastolic blood pressure is based on the average of the 3 serial trough clinic sitting systolic/diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||percentage of participants|||Number
1450615|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response at Week 8, Defined as Clinic Diastolic Blood Pressure <90 mm Hg and/or a Reduction of ≥10 mm Hg From Baseline.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at week 8, defined as less than 90 mm Hg and/or reduction from baseline of greater than or equal to 10 mm Hg. Diastolic blood pressure is the average of the 3 serial trough sitting clinic diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||percentage of participants|||Number
1450616|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450617|NCT00847626|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response at Week 8, as Defined by Clinic Systolic Blood Pressure <140 mm Hg and/or a Reduction of ≥20 mm Hg From Baseline.|Percentage of participants who achieve a clinic systolic blood pressure response measured at week 8, defined as less than 140 mm Hg and/or reduction from baseline of greater than or equal to 20 mm Hg. Systolic blood pressure is the average of the 3 serial trough sitting clinic systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||percentage of participants|||Number
1450618|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450619|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450620|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450621|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450622|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450759|NCT00846807|Secondary|Percentage of Patients With Single Components of Composite of sVTE and All-cause Mortality||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||Percentage of participants||95% Confidence Interval|Number
1450623|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450624|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450625|NCT00847626|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450626|NCT00847626|Secondary|Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450627|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough clinic sitting diastolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450628|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)|The change in trough systolic blood pressure in black participants as measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450629|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)|The change in trough systolic blood pressure in black subjects measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450630|NCT00847626|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450631|NCT00847626|Primary|Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8.|Full analysis set, defined as all randomized participants who received at least 1 dose of double-blind study medication, with both a baseline value and at least 1 post-baseline value, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1450632|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 12, 18, 24|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450783|NCT00846651|Secondary|Incidence of Maternal Bradycardia||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||percentage of participants|||Number
1450633|NCT00847613|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450634|NCT00847613|Other Pre-specified|Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.||||||
1450635|NCT00847613|Other Pre-specified|Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24||Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.||||||
1450636|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 9, 12, 15, 18, 21, 24|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.|||mmHg||Standard Deviation|Mean
1450637|NCT00847613|Other Pre-specified|Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6|BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.|Baseline, Month 1, 3, 6|Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1450638|NCT00847613|Other Pre-specified|Association Between Genomic and Metabonomic Variation||Month 24||2013-02-28|02/2013||||
1450639|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450640|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1450641|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450642|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1450674|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||mm||Standard Deviation|Mean
1450643|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450644|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1450645|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450646|NCT00847613|Other Pre-specified|Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1450647|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450648|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450649|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450675|NCT00847613|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly."|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
1450650|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response|ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450651|NCT00847613|Other Pre-specified|Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.|Baseline through Month 12, Month 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450652|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||hours per day||Standard Deviation|Mean
1450653|NCT00847613|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||hours per day||Standard Deviation|Mean
1450654|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||days||Standard Deviation|Mean
1450655|NCT00847613|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||days||Standard Deviation|Mean
1450656|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 12, 18, 24|FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||events||Standard Deviation|Mean
1450657|NCT00847613|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||events||Standard Deviation|Mean
1450676|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24|Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||mm||Standard Deviation|Mean
1450677|NCT00847613|Secondary|Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||mm||Standard Deviation|Mean
1450658|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450659|NCT00847613|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family, friends or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450660|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450661|NCT00847613|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450662|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450663|NCT00847613|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450664|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450784|NCT00846651|Secondary|Dosage of Phenylephrine Used||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||mcg of phenylephrine||Standard Deviation|Mean
1450665|NCT00847613|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450666|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.|||participants|||Number
1450667|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Month 12, 18, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450668|NCT00847613|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||participants|||Number
1450669|NCT00847613|Secondary|Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6|Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450670|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450671|NCT00847613|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450672|NCT00847613|Secondary|Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||mm||Standard Deviation|Mean
1450785|NCT00846651|Primary|Incidence of Maternal Hypotension||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||percentage of participants|||Number
1450678|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450679|NCT00847613|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450680|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Month 12 and 24|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for Month 24 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450681|NCT00847613|Secondary|Modified Total Sharp Scores (mTSS) at Baseline|mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1450682|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).||||||
1450683|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.|Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24|Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).||||||
1450684|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450685|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450686|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 indicated low disease activity, >3.2 to 5.1 indicated moderate to high disease activity and <2.6 = remission.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.|||units on a scale||Standard Deviation|Mean
1450687|NCT00847613|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1450688|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450689|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1450690|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450691|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1450692|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 9, 12, 15, 18, 21, 24|FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.|||percentage of participants|||Number
1450693|NCT00847613|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 1, 3|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1450694|NCT00847613|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.|||percentage of participants|||Number
1451006|NCT00844649|Other Pre-specified|Number of Participants With Dose Reductions|The number of participants with dose reductions occurring during the treatment period. Dose reductions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Treated Population|||participants|||Number
1450695|NCT00847613|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.|Baseline, Month 3|FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1450696|NCT00847613|Primary|Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6|mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Baseline, Month 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Error|Least Squares Mean
1450697|NCT00847613|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.|Month 6|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using Non-responder Imputation (NRI) method.|||percentage of participants|||Number
1450698|NCT00847587|Secondary|Crematocrit of Human Milk|Determination of creamatocrit is a simple method for estimating the fat & energy content of human milk based on the centrifugation of milk in a hematocrit centrifuge. The method for creamatocrit measurement was as described by Lucas et al (LucasA, GibbsJA, LysterRL, BaumJD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. BritMedJnl1978;1:1018-20)using a standard hematocrit centrifuge, standard hematocrit glass capillary tube, & vernier calipers. Measurements were performed in duplicate and the mean for each measurement used for analysis.|6 weeks postpartum|Both intent-to-treat and per-protocol analyses were performed. Per-protocol analysis is presented to demonstrate the more conservative analysis for the primary outcomes in a noninferiority study.|||Percent creamatocrit||Standard Deviation|Mean
1450699|NCT00847587|Primary|Time to Lactogenesis Stage II|The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, “Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby’s mouth, or gulping by the baby. ” If the response was positive, subjects were then asked, “When did your milk come in?” and the response recorded to the nearest hour.|5 days postpartum||||hours||Standard Deviation|Mean
1450700|NCT00847561|Primary|Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)|"The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues.~This interview will be administered by a trained staff member and will utilize information from both parents and children.~This interview will be used to determine the presence or absence of an anxiety disorder for children in this study."|12 months post-treatment||||participants with anxiety diagnosis|||Number
1450701|NCT00847535|Primary|Number of Participants That Experienced AMDC Product-related Adverse Events|"If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.~No adverse events reported during the study were adjudicated as AMDC product-related."|12 months||||participants|||Number
1450702|NCT00847535|Primary|Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.~All injection procedure-related events self-resolved or were easily treated."|30 days||||Number of events|||Number
1450703|NCT00847535|Primary|Number of Participants That Experienced Injection Procedure-related Adverse Events|"AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.~All injection procedure-related events self-resolved or were easily treated."|30 days|Sixty-four patients underwent intrasphincteric injection of AMDC.|||participants|||Number
1450704|NCT00847535|Primary|Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.~All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment||||Number of events|||Number
1451150|NCT00844298|Primary|Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy|approximate time: at the recovery of cytopenia|1 month||||percentage of analyzable subjects|||Number
1450705|NCT00847535|Primary|Number of Participants That Experienced Biopsy Procedure-related Adverse Events|"Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.~All biopsy procedure-related events either self-resolved or were easily treated."|at biopsy or between biopsy and treatment|During the study, 66 patients underwent a total of 78 biopsies.|||participants|||Number
1450706|NCT00847522|Secondary|Safety Evaluation of Intradermal Fluorescein Injections.|Number of participants that experienced an adverse event|1 month||||Participants|||Count of Participants
1450707|NCT00847522|Primary|Percentage of Agreement Between the Detection of SLNs|There is compete agreement if there are no SLNs that are either radioactive only or fluorescent only via intradermal fluorescein and technetium-99m labeled sulfur colloid.|2 days|Total number of patients with at least one SLN was 89|||percentage complete agreement|||Number
1450708|NCT00847509|Primary|[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan|The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.|3-5 weeks after the start of radiation or chemo radio therapy|||||||
1450709|NCT00847405|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1450710|NCT00847405|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1450711|NCT00847405|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1450712|NCT00847301|Secondary|Volume of Wound Drainage (Post-operative)|Volume of Wound Drainage after surgery|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||ml||Standard Deviation|Mean
1450713|NCT00847301|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings|Percentage of Patients With Major Extra-surgical Site Bleedings|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of Participants||95% Confidence Interval|Number
1450714|NCT00847301|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of Participants||95% Confidence Interval|Number
1450715|NCT00847301|Primary|Percentage of Patients With Major Bleeding Events (MBE)|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of participants||95% Confidence Interval|Number
1450716|NCT00847301|Secondary|Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality|Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated set with moderate renal impairment: this patient set included all patients with CrCl 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.|||percentage of participants||95% Confidence Interval|Number
1450717|NCT00847288|Secondary|Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year||||months||95% Confidence Interval|Median
1450718|NCT00847288|Secondary|Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews|The binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.|1 year||||percentage of visits with action|Participants|95% Confidence Interval|Mean
1450730|NCT00847197|Primary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.|||Percent Change||Standard Deviation|Mean
1450719|NCT00847288|Secondary|Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm|"There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score.~Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score."|1 year|"For each component, the subject needs to have baseline and 6 (or 12) month measurements to calculate the changes. Subjects included for the each component are as following:~Maintenance (or Confidence): 720 and 675 for monthly and quarterly arms at 6 mo, respectively, 640 and 588 at 12 mo. Management, 166 and 141 at 6 mo, 166 and 104 at 12 mo."|||units on a scale||Standard Deviation|Mean
1450720|NCT00847288|Primary|Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol||1 year|All patients enrolled in the study, who have eligible study device, signed inform consent, signed HIPAA, and have at least one OptiVol threshold crossing post the start date, were included in this analysis.|||months||95% Confidence Interval|Median
1450721|NCT00847210|Primary|Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|After 7 days of dosing.|All participants who had Vz/F estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.|||L||Standard Deviation|Mean
1450722|NCT00847210|Primary|Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.|Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.|After 7 days of dosing.|All participants who had λz estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.|||1/hr||Standard Deviation|Mean
1450723|NCT00847210|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter.|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.|After 7 days of dosing.|All participants who had CL/F estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.|||liter/hr||Standard Deviation|Mean
1450724|NCT00847210|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|After 7 days of dosing.|All participants who had T1/2 estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. No statistical tests were performed.|||hours||Standard Deviation|Mean
1450725|NCT00847210|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.|AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study).|After 7 days of dosing.|All participants who had AUC(0-24) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||ng*hr/mL/mg||Standard Deviation|Mean
1450726|NCT00847210|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.|Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|After 7 days of dosing.|All participants who had AUC(0-tlqc) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||ng*hr/mL/mg||Standard Deviation|Mean
1450727|NCT00847210|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|After 7 days of dosing.|All participants who had Cmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||ng/mL||Standard Deviation|Mean
1450728|NCT00847210|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.|After 7 days of dosing.|All participants who had Tmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the pharmacokinetic (PK) analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.|||hours||Standard Deviation|Mean
1450729|NCT00847197|Secondary|Percent Change From Baseline in Triglycerides (mg/dL)||Baseline and 4 Weeks|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.|||Percent Change||Standard Deviation|Mean
1451064|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1450731|NCT00847197|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)||Baseline and Week 4|The Full Analysis Set (FAS) population served as the primary population for the analysis of efficacy data. FAS is a subset of all randomized participants with following reasons for exclusion: 1. failure to receive at least 1 dose of study treatment 2. lack of any post-randomization endpoint data subsequent to at least 1 dose of study treatment.|||Percent Change||Standard Deviation|Mean
1450732|NCT00847145|Secondary|Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 8 to day 28 after MMRV vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
1450733|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.|From day 1 to day 7 after MMRV vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
1450734|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).|From day 1 to day 7 after each rMenB+MV NZ vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
1450735|NCT00847145|Secondary|Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.|From day 1 to day 7 after each rMenB+OMV NZ vaccination.|Analysis performed on the Safety population.|||Subjects|||Number
1450736|NCT00847145|Secondary|Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.|||Percentages of Subjects||95% Confidence Interval|Number
1450737|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers|The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.|One month after the first dose and one month after the second dose.|The analysis was done on the SBA PP Catch-up population.|||IU/mL||95% Confidence Interval|Geometric Mean
1450738|NCT00847145|Secondary|ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months|The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).|One month after the fourth (booster) dose.|The analysis was done on the SBA PP Booster population.|||IU/mL||95% Confidence Interval|Geometric Mean
1450739|NCT00847145|Secondary|Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.|One month after the second dose.||||Percentages of Subjects||95% Confidence Interval|Number
1450740|NCT00847145|Secondary|SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule|The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.|One month after the second dose.|The analysis was done on the SBA PP Catch-up population.|||Titers||95% Confidence Interval|Geometric Mean
1450741|NCT00847145|Secondary|Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)|The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.|one month after booster (fourth) dose vaccination and pre-fourth dose vaccination|This analysis was done on the PP population.|||Titers||95% Confidence Interval|Geometric Mean
1450742|NCT00847145|Secondary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)|Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|One month post vaccination and pe-booster (fourth) dose vaccination|The analysis was done on PP population.|||Percentages of subjects||95% Confidence Interval|Number
1450743|NCT00847145|Secondary|Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)|The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.|one month after third vaccination and pre dose fourth (booster) vaccination||||Titers||95% Confidence Interval|Geometric Mean
1450745|NCT00847145|Secondary|Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination|"Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone.~The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection."|one month after booster (fourth) dose|This analysis was done on Per Protocol (PP) population.|||Percentages of subjects||95% Confidence Interval|Number
1450746|NCT00847145|Primary|Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination|Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.|one month after the booster (fourth) dose|The analysis was done on Per Protocol (PP) population – subjects who received all doses of vaccine in parent & present study, provided evaluable serum samples at 1 month after booster dose or 1 month after 2nd dose, blood draw at 1 month after 3rd injection at 6 months in parent & visit 1 blood draw in present study, had no major protocol violation|||Percentages of subjects||95% Confidence Interval|Number
1450747|NCT00847132|Secondary|Change in Depression Symptoms From Baseline to 6 Months|Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.|Baseline, 6 weeks, 12 weeks, 6 months||||units on a scale||95% Confidence Interval|Mean
1450748|NCT00847132|Primary|Rates of Adequate Depression Treatment at Discharge|"Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers’ package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions).~Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects."|5 days after enrollment||||percentage of participants|||Number
1450749|NCT00847015|Secondary|The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.|The time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.|2 years||||months||95% Confidence Interval|Median
1450750|NCT00847015|Secondary|The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|is defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years||||percentage of participants||95% Confidence Interval|Number
1450751|NCT00847015|Primary|The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.|Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|2 years||||percentage of participants||95% Confidence Interval|Number
1450752|NCT00847002|Secondary|Reduction in Leg Volume||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.||||||
1450753|NCT00847002|Primary|Wound Healing||12 weeks|The study was stopped early due to lack of enrollment statistical analysis was not completed.||||||
1450754|NCT00846885|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1450755|NCT00846885|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1450756|NCT00846885|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1450757|NCT00846846|Secondary|Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.|Total death and and number of patients with all non-fatal myocardial infarction. Cardiac death and number of patients with all non-fatal myocardial infarction. Total death and number of patients with large non-fatal myocardial infarction. Cardiac death and number of patients with large non-fatal myocardial infarction.|3 years|Main secondary endpoint results for the ITT population are similar to the primary endpoint analysis, a total of nine hundred and forty seven (947) ITT patients had sufficient follow-up or an event to be included in the main secondary endpoint analyses.|||percentage of participants||95% Confidence Interval|Number
1450758|NCT00846846|Primary|To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation|The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.|3 years|Of the one thousand and eighteen (1018) ITT patients, a total of nine hundred and forty seven (947) patients were included in the primary endpoint analysis. These patients had at least 1050 days of follow-up or had experienced stent thrombosis prior to 1080 days.|||percentage of participants||95% Confidence Interval|Number
1451562|NCT00841776|Secondary|Median Change in Total Acne Lesions|Median Change in Total Acne Lesions|Baseline, Weeks 2, 4, 8, 12, and 16|ITT|||Total Acne Lesion Counts||Inter-Quartile Range|Median
1450760|NCT00846807|Secondary|Volume of Wound Drainage (Post-operative)|Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.|From end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||ml||Standard Deviation|Mean
1450761|NCT00846807|Secondary|Percentage of Patients With Major Extra-surgical Site Bleedings||From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||Percentage of participants||95% Confidence Interval|Number
1450762|NCT00846807|Primary|Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality|The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE).|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|TS|||Percentage of participants||95% Confidence Interval|Number
1450763|NCT00846807|Primary|Percentage of Patients With Major Bleeding Events (MBE) During Treatment Period|Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation|From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa|Treated Set (TS) comprises all patients who completed the surgery and received at least 1 dose of dabigatran etexilate.|||Percentage of participants||95% Confidence Interval|Number
1450764|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 24 Hours|Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.~This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."|||percent||Geometric Coefficient of Variation|Geometric Mean
1450765|NCT00846768|Secondary|Pharmacokinetics (PK): Fraction of Analyte Eliminated in Urine at Steady State From Time Point 0 Hours to Time Point 12 Hours|"Fraction of analyte eliminated in urine at steady state from time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.~Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||percent||Geometric Coefficient of Variation|Geometric Mean
1450766|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 24 Hours|Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 24 hours after dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.~This endpoint was only calculated for the two qd dose regimens, therefore the number of patients in the Olo 2 Mcg Bid Arm and the Olo 5 Mcg Bid Arm is 0."|||ng||Geometric Coefficient of Variation|Geometric Mean
1450767|NCT00846768|Secondary|Pharmacokinetics (PK): Amount of Analyte That is Eliminated in Urine at Steady State From the Time Point 0 Hours to Time Point 12 Hours|"Amount of analyte that is eliminated in urine at steady state from the time point 0 hours to time point 12 hours after dosing in week 3 (after the morning dose for the bid dose regimens). The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters.~Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range."|3 weeks|All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data.|||ng||Geometric Coefficient of Variation|Geometric Mean
1450768|NCT00846768|Secondary|Pharmacokinetics (PK): Concentration of the Analyte in Plasma Measured at 0.167 Hours Post Dosing at Steady State|Steady state concentration of the analyte in plasma measured at 0.167 hours post dosing in week 3. The start of inhalation was used as time point 0 for calculation of pharmacokinetic parameters. Descriptive statistics were calculated only if N>=16 had concentrations within the validated concentration range.|3 weeks|"All evaluable subjects. A subject was considered to be not evaluable if the subject had a protocol violation relevant to the evaluation of PK parameters or had insufficient data. In the Olo 2 mcg Bid Arm, there were only 14 patients with values within the validated concentration range."|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1450769|NCT00846768|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|3 weeks|Treated set.|||percentage of participants|||Number
1450770|NCT00846768|Secondary|Trough FVC Response|Response was defined as change from baseline. Study baseline trough FVC was defined as the mean of the available pre-dose trough FVC values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450771|NCT00846768|Secondary|Peak FVC (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450772|NCT00846768|Secondary|FVC Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1, 0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450773|NCT00846768|Secondary|FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450774|NCT00846768|Secondary|FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FVC AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450775|NCT00846768|Secondary|Trough FEV1 Response|Response was defined as change from baseline. Study baseline trough FEV1 was defined as the mean of the available pre-dose trough FEV1 values prior to first dose of treatment. Trough values were the mean of values obtained 23h and 23 h 50 min after the last dose of study drug after three weeks of treatment .|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450776|NCT00846768|Secondary|Peak FEV1 (0-3h) Response After 3 Weeks|Response was defined as change from baseline. Study baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after the last dose after three weeks of treatment.|Baseline, 3 weeks|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450777|NCT00846768|Secondary|FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-24h was calculated from 0-24 hours post-dose using the trapezoidal rule, divided by the observation time (24h) to report in litres.|Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450778|NCT00846768|Primary|FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450779|NCT00846768|Primary|FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment|Response was defined as change from baseline. Baseline FEV1 AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose|Full analysis set (FAS). FAS is defined as all randomised and treated patients with baseline (pre-dose) data and evaluable post-dose data for at least one period.|||Liter||Standard Error|Least Squares Mean
1450780|NCT00846651|Secondary|Incidence of Maternal Nausea and Vomiting||participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby||||percentage of participants|||Number
1450781|NCT00846651|Secondary|APGAR Scores|The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10 with higher scores being better than lower scores. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration).|Apgar scores were assessed at 1 amd 5 min after delivery of the baby||||units on a scale||Full Range|Median
1450782|NCT00846651|Secondary|Fetal Cord Blood pH||delivery of the baby|Physician policy changes resulted in blood gas values not being ordered and thus data was not available for the outcome measure.||||||
1450786|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1450787|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 4 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1450788|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose on Day 2|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1450789|NCT00846586|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose on Day 1|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1450790|NCT00846586|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1450791|NCT00846586|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.|From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)|Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1450792|NCT00846573|Primary|Hyperpolarized Helium-3 MR Images|We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder.|15 second breath-hold|We recruited participants of each category until we were satisfied with the images we obtained.|||participants|||Number
1450793|NCT00846547|Primary|Irritability Subscale of the Aberrant Behavior Checklist, Community Version|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|At 8 weeks during the treatment period||||Points on a scale||Standard Error|Least Squares Mean
1450794|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||After 6 Weeks (post treatment)|The number of participants who completed the study were analyzed|||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
1450795|NCT00846521|Primary|Mean Percentage of Glucose Values ≥ 140 mg/dl Over 72 Hours of Glucose Readings Measured With a Continuous Glucose Monitor||At baseline (before treatment)|The number of participants who completed the study were analyzed|||percentage of glucose excursions ≥ 140||Standard Deviation|Mean
1450796|NCT00846495|Secondary|Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine|Average cost of study medication taken by each subject. Measured in dollars.|Treatment Months 1 and 2||||Dollars (US)||Standard Deviation|Mean
1450797|NCT00846495|Secondary|Adverse Events Associated With Study Medications|Includes Adverse Events at or above 5% frequency per group.|Treatment Months 1 and 2||||Adverse Events|Participants||Number
1450798|NCT00846495|Secondary|Participant Satisfaction With Study Medications|"Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.~Participants completed the PPMQ 24 hours following each first dose of frovatriptan."|Treatment Month 2||||Score on a Scale||Standard Deviation|Mean
1450799|NCT00846495|Secondary|Quality of Life in Subjects Utilizing Each Treatment Paradigm|Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.|Randomization, End of Treatment Month 1, End of Treatment Month 2||||Score on a Scale||Standard Deviation|Mean
1450800|NCT00846495|Secondary|Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm|Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2|2 Months||||Participants|||Number
1450801|NCT00846495|Secondary|Number of Headache Days Each Month Following Initiation of Treatment With Study Medication|Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication|2 Months|Number of Units Analyzed is equivalent to number of headache days reported during Treatment Months 1 and 2.|||Headache Days|Participants|Standard Deviation|Mean
1450802|NCT00846495|Primary|Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine|Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine|Treatment Month 2||||Headache Days||Standard Deviation|Mean
1450803|NCT00846495|Primary|Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate|Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2|Treatment Month 2|Number of Units Analyzed is equivalent to number of migraine attacks reported during 2nd Treatment Month.|||Migraine attacks|Participants|Standard Deviation|Mean
1450804|NCT00846391|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|"The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values.~Blood samples for glucose were to be collected immediately prior to (sample -10 minutes), and 0, 15, 30, 60, 90, 120, and 180 minutes after each meal, and overnight (at midnight, 3 AM, and 5 AM) and fasting at 7 AM. Patients were to be domiciled for approximately 26 hours at the site where standard meals were provided and physical activity monitored."|Baseline and Week 4|The analysis population included all patients with a baseline value and Week 4 value for this outcome.|||mg/dL||Standard Deviation|Mean
1450805|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic AND Systolic Blood Pressure Response, Defined as <140/90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease (CKD) or <130/80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve both a clinic diastolic blood pressure response, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease (CKD) or <130/80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||percentage of participants|||Number
1450806|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as Defined as <90 mm Hg for Participants Without Diabetes or CKD or <80 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic diastolic blood pressure response, defined as defined as <90 mm Hg for participants without diabetes or CKD or <80 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||percentage of participants|||Number
1450807|NCT00846365|Secondary|Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as <140 mm Hg for Participants Without Diabetes or CKD or <130 mm Hg for Participants With Diabetes or CKD|Percentage of participants who achieve a clinic systolic blood pressure response, defined as <140 mm Hg for participants without diabetes or CKD or <130 mm Hg for participants with diabetes or CKD at each time frame relative to baseline.|Baseline, Week 2, Week 4, Week 6 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||percentage of participants|||Number
1450808|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1451563|NCT00841776|Secondary|Median Change in Erythromycin-resistant P. Acne Counts|Total colony forming units of erythromycin-resistant p. acnes.|Baseline, Weeks 2, 4, 8, 12, and 16|ITT|||Erythromycin-resistant P. acne counts||Inter-Quartile Range|Median
1450809|NCT00846365|Secondary|Change From Baseline in 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 12 hours-after-dosing mean Systolic Blood Pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night The mean consists of the average (arithmetic mean) of measurements collected at each time frame and includes all observations recorded over the subsequent 12 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450810|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the nighttime, while asleep (12am to 6am) mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average (arithmetic mean) of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450811|NCT00846365|Secondary|Change From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the nighttime, while asleep (12am to 6am) mean systolic blood pressure measured at Week 4 and Week 8 to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of measurements recorded between the hours of 12 AM (inclusive) and 6 AM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450812|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean diastolic blood pressure measured at Week 4 and Week 8relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450813|NCT00846365|Secondary|Change From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the daytime, while awake (6am to 10pm) mean systolic blood pressure measured at Week 4 and Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night Daytime mean is the average of measurements recorded between the hours of 6 AM (inclusive) and 10 PM (exclusive) included in the 24-hour mean calculations.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450814|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in the 0 to 24-hours-after-dosing mean diastolic blood pressure measured at Week 4 and Week 8 relative to baseline. . Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The mean consists of the average of measurements collected over the subsequent 24 hours.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450815|NCT00846365|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 24-hour mean systolic blood pressure at week4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450816|NCT00846365|Secondary|Change From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450830|NCT00846027|Secondary|Duration of the Objective Response|Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response were included in the analysis.|||Months||95% Confidence Interval|Median
1450817|NCT00846365|Secondary|Change From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at week 4 and week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 4 and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Error|Least Squares Mean
1450818|NCT00846365|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 4 and week 8 relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline, Week 4 and Week 8.|Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Deviation|Least Squares Mean
1450819|NCT00846365|Secondary|Change From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 4 relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 4.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.|||mmHg||Standard Deviation|Least Squares Mean
1450820|NCT00846365|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.|The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8.|Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.|||mmHg||Standard Deviation|Least Squares Mean
1450821|NCT00846287|Secondary|Change in FEV1|Spirometry was taken which measures FEV1 (in Litres), before administration of an intervention and again 2 hours after administration of an intervention. The change in FEV1 (Litres) from pre-nebulizer inhalation to post-nebulizer inhalation was compared.|2 hours|As per protocol|||Litres||Standard Deviation|Median
1450822|NCT00846287|Primary|Change in Total Ventilation Volume|"Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described:~The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation."|2 hours|Analysis per protocol.|||Litres||Standard Deviation|Mean
1450823|NCT00846066|Primary|Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months|The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%|At baseline and 6 months|Analysis per protocol. Subjects dropped from analysis because charts not available within the time frame of the study and incomplete data.|||Percent change||Standard Deviation|Mean
1450824|NCT00846066|Primary|Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months|"Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the agree and strongly agree responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months||||Percent change||Standard Deviation|Mean
1450825|NCT00846066|Primary|Percent Change From Baseline in Confidence at 4 Months|"Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of very confident was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%"|Baseline and 4 months|Only completed paired (pre/post intervention) surveys were analyzed|||Percent change.||Standard Deviation|Mean
1450826|NCT00846066|Primary|Mean Percentage of Correct Skills|Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups|3 months after Hands-on Training (HOT)||||Percentage of correct skills||Standard Deviation|Mean
1450827|NCT00846053|Secondary|Sputum Neutrophil Elastase (NE) Concentration|Using established techniques, functional activity of neutrophil elastase in sputum sols were measured using methoxy-succinyl-ala-ala-pro-val-nitroanilide (Elastin Products, Owensville, MO), specific peptide chromogenic substrates of the neutrophil protease|Sample collected within 2-hours of PET scan|Not every participant in the stable lung function group could produce sputum.|||microgram (mcg) NE /mcg protein||Standard Deviation|Mean
1450828|NCT00846053|Primary|Kinetic Influx Constant (Ki)|The whole lung kinetic influx constant (Ki) is the primary outcome measure that is derived from the time-activity curves, which are generated from regions of interest placed over the whole lungs. Therefore, a single time-activity curves from each scan is used to derive the Ki.|At the time of FDG scan, 1 to 2 hours|CF adolescents and young adults, ages 12 to 21 years, who did not have CFRD.|||mL/min/mL||Standard Deviation|Mean
1450829|NCT00846027|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.|||Months||95% Confidence Interval|Median
1450831|NCT00846027|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study. Only participants who had a response evaluation were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1450832|NCT00846027|Primary|Progression-free Survival|Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.|Baseline to the end of the study (up to 2 years 10 months)|Intent-to-treat population: All participants who were enrolled in the study.|||Months||95% Confidence Interval|Median
1450833|NCT00845975|Secondary|Spielberger State-Trait Anxiety Inventory (STAI)- Trait Portion|The Trait portion of the State-Trait Anxiety Inventory (STAI-T) evaluates an individual’s tendency to get anxious and how they respond to stress. The STAI-T has 20 items rated on a 4-point frequency of occurrence scale of 1=Almost Never, 2=Sometimes, 3=Moderately So, and 4=Very Much So. The individual scores are summed to get the total STAI-T score. The higher the total score, the more anxious the individual, and the lower the total score, the less anxious the individual. Change in STAI-T score is calculated as the STAI-T score at 4 weeks after baseline evaluation minus the STAI-T score at baseline. A positive (+) change in STAI-T score indicates that the anxiety has worsened. A negative (-) change in STAI-T score indicates the depression has lessened. A change in STAI-T score of -8 or greater indicates a meaningful lessening of anxiety and is positive for study success.|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1450834|NCT00845975|Secondary|Beck Depression Inventory-II (BDI-II)|The Beck Depression Inventory®-II (BDI®–II) is a 21-item questionnaire used to assess depression. Most items are rated on a 4-point scale from 0 to 3, and a few items are rated on a 7-point scale. Individual item scores are added to get a total score from 0 to 63. The higher the total score, the more severe the depression, and the lower the total score, the less severe the depression. Change in BDI®–II score is calculated as the BDI®–II score 4 weeks after baseline evaluation minus the BDI®–II score at baseline. A positive (+) change in BDI®–II score indicates that the depression has worsened. A negative (-) change in BDI®–II score indicates the depression has lessened. A change in BDI®–II score of -6 or greater indicates a meaningful lessening of depression and is positive for study success.|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
1450835|NCT00845975|Primary|Total Score on the Tinnitus Handicap Inventory (THI).|The Tinnitus Handicap Inventory (THI) is a 25-item questionnaire to assess how tinnitus affects an individual’s life. Each question is responded to as ‘yes’ (4 points); ‘sometimes’ (2 points) or ‘no’ (0 points). The individual scores for the 25 questions are added to get a total THI score from 0 to 100. The higher the total THI score, the greater the negative impact tinnitus has on the individual’s life. Change in total THI score is calculated as total THI score after the one week procedure administration phase minus total THI score at baseline. A positive (+) change in total THI score indicates the negative impact of tinnitus on the individual’s everyday life has worsened. A negative (-) change indicates the negative impact of tinnitus on the individual’s everyday life has improved (lessened). A change in total THI score of -20 or greater indicates a meaningful lessening of the impact of tinnitus on the individual’s life and is positive for study success.|baseline and one week||||units on a scale||Standard Deviation|Mean
1450836|NCT00845897|Secondary|Barefoot Plantar Pressure|Novel emed pressure platform was used for data collection. A two-step method of data collection was used and a minimum of two trials of each foot were recorded. The plantar pressure map was divided into 3 horizontal masks using Percent Mask software and peak plantar pressure was determined for the forefoot region. Results are expressed in N/cm^2.|pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing||||Peak Plantar Pressure (N/cm^2) changes||Standard Deviation|Mean
1450837|NCT00845897|Primary|Plantar Flexor Muscle Strength|Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing & Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.|Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing||||Plantar Flexor Torque (Nm)||Standard Deviation|Mean
1450838|NCT00845858|Other Pre-specified|The Pre-specified Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score by Gender.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female subjects receiving placebo.~The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).~Nausea (feeling sick to your stomach as if you were going to vomit or throw up)~Early satiety (not able to finish a normal sized meal)~Bloating (feeling like you need to loosen clothes)~Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.~A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks||||units on a scale||Standard Deviation|Mean
1450866|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
1450867|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
1450839|NCT00845858|Primary|The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.|"Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.~The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).~Nausea (feeling sick to your stomach as if you were going to vomit or throw up)~Early satiety (not able to finish a normal sized meal)~Bloating (feeling like you need to loosen clothes)~Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.~A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful."|4 weeks|ITT|||units on a scale||Standard Deviation|Mean
1450840|NCT00845845|Secondary|Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.||||||
1450841|NCT00845845|Primary|Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)||24 weeks|This study was terminated on October 12, 2010 due to low enrollment. Primary analyses were never completed.||||||
1450842|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant’s Assessment of Pain|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
1450843|NCT00845832|Secondary|Change From Baseline to Week 48 in Participant’s Global Assessment of Disease Activity|Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
1450844|NCT00845832|Secondary|Change From Baseline to Week 48 in Physician’s Global Assessment of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
1450845|NCT00845832|Secondary|Change From Baseline to Week 48 in ESR|ESR is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
1450846|NCT00845832|Secondary|Change From Baseline to Week 48 in C-Reactive Protein (CRP)|CRP is an acute phase reactant and is a measure of inflammation.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
1450847|NCT00845832|Secondary|Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ)|The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments.|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
1450848|NCT00845832|Secondary|Change From Baseline to Week 48 in SJC and TJC|An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints).|Baseline and Week 48|Data were not collected because the study was terminated early.||||||
1450849|NCT00845832|Secondary|Simplified Disease Activity Index (SDAI) Scores|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48|Data were not collected because the study was terminated early.||||||
1450850|NCT00845832|Secondary|Clinical Disease Activity Index Scores|"The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10~Where:~SJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant’s global assessment of disease activity; EGA = evaluator’s (physician’s) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity >22; moderate disease activity >10 and ≤22; LDA >2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||units on a scale||Standard Deviation|Mean
1450851|NCT00845832|Secondary|Change From Baseline in DAS28-ESR|"The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).~DAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 * √TJC)+(0.28 * √SJC)+(0.70 * ln(ESR))+(0.014 * GH).~No imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS."|Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Population; number (n) = number of participants analyzed at the specified visit.|||units on a scale||Standard Deviation|Mean
1450868|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 h and 24 h after injection|Intent-to-treat population|||Participants|||Number
1450852|NCT00845832|Secondary|Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or DAS28-ESR >5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 16|ITT Population; No imputation used for TJC, SJC, ESR, and PtGA. EULAR response was set to missing when the DAS28 score was missing.|||percentage of participants|||Number
1450853|NCT00845832|Secondary|Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR|The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (<) 2.6|Week 16|ITT Population; LOCF used for TJC, ESR, and PtGA. If the DAS28-ESR value was missing then remission or LDA was missing.|||percentage of participants|||Number
1450854|NCT00845832|Primary|Percentage of Participants Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)|"The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC [28 joints]), Swollen Joint Count (SJC [28 joints]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2.~DAS28-ESR equals (=) (0.56 times (*) (square root)√ TJC plus (+) (0.28 * √ SJC + (0.70 * ln(ESR))+(0.014 * (Global Health) GH)~Where:~TJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant’s global assessment of disease activity ln = natural log"|Week 16|Intent-to-Treat (ITT) Population: all randomized participants who received any part of an infusion of study medication. Last observation carried forward (LOCF) used for TJC and SJC, ESR and PtGA. If DAS28-ESR value was missing LDA was missing.|||percentage of participants|||Number
1450855|NCT00845728|Secondary|Rate of COPD Exacerbations|COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.|52 weeks|Per-Protocol Set for Exacerbations (PPS-E). This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.|||Exacerbations per patient per year|||Number
1450856|NCT00845728|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1).|The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.|12 weeks|Per-Protocol Set for Spirometry (PPS-S) This set included Full Analysis Set (FAS) patients without any major protocol deviations or non-protocol deviation criteria that could affect the respective analysis of efficacy.|||Liters||Standard Error|Least Squares Mean
1450857|NCT00845702|Primary|Percent of Non Assessable Renal Artery Segments|For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared|1 to 7 days|The study has been prematurely terminated, and the planned analyses were not done||||||
1450858|NCT00845676|Secondary|Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype|Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR|24 weeks|||||||
1450859|NCT00845676|Secondary|Safety and Tolerability of Treatment|Number of participants with treatment-associated problems|48 weeks|||||||
1450860|NCT00845676|Primary|Sustained Virologic Response (SVR)|Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment|24 weeks||||percentage of participants|||Number
1450861|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
1450862|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
1450863|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
1450864|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
1450865|NCT00845663|Secondary|Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching|Categorized answer ranges from not at all to extremely.|Immediately after injection, 1 hour and 24 hours after injection|Intent-to-treat population|||Participants|||Number
1450871|NCT00845663|Secondary|Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection|Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).|Immediately after injection and 1 hour after injection|Intent-to-treat population|||Units on a scale||Standard Deviation|Mean
1450872|NCT00845663|Secondary|Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||Participants|||Number
1450873|NCT00845663|Secondary|Apparent Volume of Distribution (Vz/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||L||Full Range|Geometric Mean
1450874|NCT00845663|Secondary|Apparent Total Body Clearance (CL/F)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||mL/day||Full Range|Geometric Mean
1450875|NCT00845663|Secondary|Time Corresponding to Cmax (Tmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
1450876|NCT00845663|Secondary|Apparent Terminal Elimination Half-life (t1/2)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
1450877|NCT00845663|Secondary|Apparent Terminal Elimination Rate Constant (λz)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||1/day||Standard Deviation|Mean
1450878|NCT00845663|Secondary|Lowest Quantifiable Concentration Time (LQCT)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
1450879|NCT00845663|Secondary|Time Point Where Log-linear Elimination Phase Begins (TLIN)|TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.|After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||days||Full Range|Median
1450880|NCT00845663|Primary|Maximum Plasma Concentration (Cmax)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||microgram/mL||Full Range|Geometric Mean
1450881|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||microgram*day/mL||Full Range|Geometric Mean
1450882|NCT00845663|Primary|Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)||After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12|Per Protocol Population|||microgram *day/mL||Full Range|Geometric Mean
1450883|NCT00845650|Secondary|Mean Residence Time (MRT)|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||hours||Standard Deviation|Mean
1450884|NCT00845650|Secondary|Elimination Half-life (t½)|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||hours||Full Range|Median
1450885|NCT00845650|Secondary|Elimination Rate Constant|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||/h||Standard Deviation|Mean
1450886|NCT00845650|Secondary|Area Under the Curve to Infinity (AUC[0-inf])|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||h*NF50||Standard Deviation|Mean
1450887|NCT00845650|Secondary|Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||h*NF50||Standard Deviation|Mean
1450888|NCT00845650|Secondary|Time of Cmax|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||hours||Standard Deviation|Mean
1450889|NCT00845650|Secondary|Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)|Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard.|From the time of infusion through Day 90 postinfusion.|Pharmacokinetic (PK) intent-to-treat (ITT) population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.|||NF50 (50% neutralization factor)||Standard Deviation|Mean
1450890|NCT00845650|Primary|Number of Participants Reporting Adverse Events (AEs)|Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).|From the time of infusion through Day 90.|Safety Population: all subjects who received any infusion of AIGIV or Gamunex.|||Participants|||Count of Participants
1450891|NCT00845520|Other Pre-specified|Percentage of Eyes With Best Corrected Visual Acuity (BSCVA) of 20/40 or Better|Best Corrected Visual Acuity (BSCVA): The percentage of eyes achieving overall and best case BSCVA of 20/40 or better should be comparable to the FDA grid of historical controls for intraocular lenses. All three arms of the study had the same end point so the results were presented as one combined cohort.|12 months|All available eyes at 12 months. The overall number of participants for this outcome measures differs the previously stated overall number of 74 because two subjects were deceased at their 12 month post-operative follow up visit.|||percentage of eyes|||Number
1450892|NCT00845520|Secondary|Percentage of Participants With Eyes With Improvement in Uncorrected Visual Acuity (UCVA)|Improvement in uncorrected visual acuity (UCVA): For those best case eyes with a pre-light treatment UCVA of 20/50 or worse, 65% of eyes should have an uncorrected visual acuity of 20/40 or better at the refractive stable point after the adjustment and lock-in treatments. All three arms of the study had the same end point so the results were presented as one combined cohort.|6 months post operative|Participants with eyes with UCVA of 20/50 or worse UCVA prior to light treatment|||percentage of eyes|||Number
1450893|NCT00845520|Primary|Percentage of Eyes Achieving a Manifest Refraction Spherical Equivalent (MRSE) Within ± 0.50 D of the Intended Adjustment Target|Predictability of post-operative refractive adjustments of the implanted LAL, with 75% of the eyes achieving a manifest refraction spherical equivalent (MRSE) within ± 0.50 D of the intended adjustment target at the point of stability. All three arms of the study had the same end point so the results were presented as one combined cohort.|6 months post-operative|ITT|||percentage of eyes|||Number
1450894|NCT00845507|Secondary|Change in Body Mass Index (BMI) From Baseline to Endpoint.|Secondary outcome measures included change in body mass index (BMI).|16 Weeks|All subjects who took at least one dose of study medication and had one post-baseline evaluation.|||Kgs/meter squared||Standard Deviation|Mean
1450895|NCT00845507|Primary|Change in Weight From Baseline to Endpoint.|Change in weight from baseline to endpoint in the intent-to-treat (ITT) population (all subjects who took at least one dose of study medication and had one post-baseline evaluation).|16 Weeks|All subjects who took at least one dose of study medication and had one post-baseline evaluation.|||Pounds||Standard Deviation|Mean
1450896|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
1450897|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
1450898|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
1450899|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
1450900|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
1450901|NCT00845481|Primary|The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment|The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)|Baseline and 3 weeks||||Scores on a scale||Standard Error|Mean
1450902|NCT00845429|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.|"Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.~Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1450903|NCT00845429|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.|"Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.~Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21."|Day 21 post-vaccination|Seroconversion and significant increase in Influenza vaccine antibodies were assessed in the full analysis set population.|||Percentage of Participants|||Number
1450904|NCT00845429|Primary|Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.|Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)|Day 21 post-vaccination|Seroprotection was assessed in the full analysis set population.|||Percentage of Participants|||Number
1450905|NCT00845429|Primary|Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.||Days 0 and 21 post-vaccination|Geometric mean titers were assessed in the full analysis set population.|||Titers||95% Confidence Interval|Geometric Mean
1451111|NCT00844532|Secondary|Technical Success|Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of < 30% by QA or as reported by the investigator, if QA is not available.|acute: from beginning of index procedure to end of index procedure.|ITT population|||percentage of target lesions|Participants|95% Confidence Interval|Number
1450906|NCT00845195|Primary|Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
1450907|NCT00845195|Primary|Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline|Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
1450908|NCT00845195|Primary|Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline|Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
1450909|NCT00845195|Primary|Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline|Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.|14 days minus baseline|The analysis was per protocol. 15 patients were not included in the analysis.|||Units on a scale||Standard Deviation|Mean
1450910|NCT00845182|Secondary|Effect Pioglitazone, Exenatide, and Pioglitazone Plus Exenatide • Insulin Sensitivity • Inflammatory Cytokines • Glucagon and Free Fatty Acids • Plasma Lipids|"Effect pioglitazone, exenatide, and pioglitazone plus exenatide on~Insulin sensitivity~Inflammatory cytokines~glucagon and free fatty acids~plasma lipids measured over a 6 month period"|6 months|Data were not collected for this analysis||||||
1450911|NCT00845182|Primary|HbA1c|change in HbA1c was measured before and after treatment in three groups|baseline and 6 months|There was a greater improvement in HbA1c from baseline after combined treatment with Pioglitazone and Exenatide when compared with either therapy alone.|||percent point decrease from baseline||Standard Deviation|Mean
1450912|NCT00845182|Primary|Effect of Pioglitazone, Exenatide and Combined Pioglitazone and Exenatide on Body Weight|Effect of Pioglitazone, Exenatide and combined Pioglitazone and Exenatide on body weight and beta cell function|baseline and 6 months|we analyzed the weight at the end of study completion|||kg||Standard Deviation|Mean
1450913|NCT00845130|Primary|Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier|Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.|2 hour post infusion|Data from one healthy subject were not usable due to subject's movement during MRI scan.|||µmol/g tissue||Standard Deviation|Mean
1450914|NCT00845130|Primary|Concentration of Vitamin C in Type 2 Diabetic Patients.|Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.|Pre-Vitamin C infusion|Determine cerebral concentrations of vitamin C. Data from one healthy subject were not usable due to subject's movement during MRI scan.|||umol/g tissue||Standard Deviation|Mean
1450915|NCT00845065|Secondary|Mean Log Change From Baseline to TW 4 in Viral Load by Visit|HCV-RNA levels were quantified using the Roche Cobas Taqman 1.0 assay; lower limit of detection of 15 international units [IU]/mL. Changes in HCV-RNA IU/ml were expressed on a log10 scale.|From Baseline to TW 4|FAS Population|||log10 (IU/mL)||Standard Deviation|Mean
1450916|NCT00845065|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12||Follow-up Week 12|FAS Population|||Participants|||Number
1450917|NCT00845065|Secondary|Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR|EVR was defined as the time to the first undectectable HCV-RNA result at Treatment Week (TW) 2, 4, 8, or 12. Participants with a detectable, but not quantifiable HCV-RNA result at TW 12 may have undergone retesting. Participants with a detectable result on retesting were to be discontinued per the 12-week futility rule. Participants with an undetectable result on retesting were allowed to continue on treatment, and the detectable but not quantifiable result was to be considered a false positive.|Day 1 to Treatment Week 12|FAS Population|||Percentage of Participants|||Number
1450918|NCT00845065|Secondary|SVR Rate in the Modified Intent-to-Treat (mITT) Population|SVR rate was the percentage of participants treated with at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included in the mITT population.|Follow-up Week 24|mITT Population: all randomized participants who received at least one dose of study medication (Boceprevir/PEG2a/Ribavirin or PEG2a/Ribavirin). Participants who discontinued study drugs during the 4-week PEG2a/Ribavirin lead-in period were not included. FU W12 value was LOCF, if last SVR value at or after FU W24 was not available.|||Percentage of Participants|||Number
1450942|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (0-4 Year Old Version) at Six Months|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (0-4 year old version). Parent-rated questionnaire that focuses on child's pain and parent's worry. Scores range from 5-24, with a higher score indicative of worse outcomes. Change in scores was measured from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1450919|NCT00845065|Primary|Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population.|SVR rate was the percentage of participants treated with at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo) who had achieved SVR. SVR was defined as undetectable Hepatitis C Virus-Ribonucleic Acid (HCV RNA).|Follow-up Week 24|FAS Population: all randomized participants who received at least one dose of study medication (PEG2a, Ribavirin, or Boceprevir/Placebo). Follow-up (FU) Week (W) 12 value was Last Observation Carried Forward (LOCF), if last SVR value at or after FU W24 was not available.|||Percentage of Participants|||Number
1450920|NCT00845039|Other Pre-specified|The Number of Participants Who Died During 30-Day Follow-Up|Reported are the deaths during the 30-day follow-up period regardless of causality.|26.3 months post-randomization up to 30-day post-treatment follow-up|All randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1450921|NCT00845039|Secondary|Serum Anti-IMC-A12 Antibody Assessment||Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450922|NCT00845039|Secondary|Change in Behavioral and Health Outcomes [BAHO] Quality of Life (QoL) Questionnaire||Baseline, after Cycle 3 (14-day cycle), study discontinuation 30-day follow-up (up to 26.3 months)|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450923|NCT00845039|Secondary|Post-treatment Serum Levels of IMC-A12 in Participants Receiving IMC-A12||Prior to infusion at Cycles 1, 4, 7 (2-week cycles), and 4 to 6 weeks following discontinuation of treatment IMC-A12 up to 77 weeks|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450924|NCT00845039|Secondary|Toxicity of the Irinotecan + Cetuximab + IMC-A12 Regimen||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450925|NCT00845039|Secondary|The Number of Participants Who Had a Complete Resection/Ablation of Metastases With no Evidence of Disease Remaining (Resection Rate)||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450926|NCT00845039|Secondary|Progression Free Survival (PFS) Over Entire Duration||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450927|NCT00845039|Secondary|Overall Survival (OS)||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450928|NCT00845039|Secondary|Objective Response Rate (ORR) [Complete Response (CR) + Partial Response (PR)]||Randomization up to 26.3 months|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450929|NCT00845039|Primary|Progression-Free Survival (PFS) Rate at 18 Weeks||Approximately 18 Weeks|Zero participants analyzed. Per Clinical Study Report, decision made by ImClone and NSABP at time of study closing to not perform summary analysis on N= 4 due to validity of data related to low number of participants and concerns on maintaining participant confidentiality for low number of participants.||||||
1450930|NCT00845000|Secondary|Mean Peak Walking Speed|Walking speed assessment began with the participant being seated in an armless chair. Then while being timed, the participant stood up with their arms crossed on their chest and walked 6 meters, turned around, returned to the chair and sat. Timing was stopped when the participant’s buttocks hit the chair and the total time was recorded. If the participant could not arise in 60 seconds, 60 seconds was entered in this line of the report form and the participant was tested again but allowed to push off to get out of the chair. Sixty seconds was the maximum time allowed to complete the walking assessment, thus 60 seconds was recorded as the time if they could not complete the task within this time limit. Walking speed was assessed at Hours 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7.0 and 8. The peak walking speed was recorded for each participant regardless of what timepoint the score was achieved. The mean peak walking speed was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||Seconds||Standard Deviation|Mean
1450943|NCT00844883|Secondary|Efficacy - Factors Associated With Overall Survival (OS) After Combination Treatment With Sorafenib and TACE|Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.|3 years||||Hazard ratio||95% Confidence Interval|Number
1450944|NCT00844883|Secondary|Efficacy - Overall Survival (OS) After Combination Treatment With Sorafenib and TACE|"Overall survival was assessed with Kaplan-Meier estimates of survival, and the Mantel-Cox log-rank test was used to determine differences in survival.~All 50 patients were included in survival analyses as all 50 received at least one dose of sorafenib."|3 years||||months||Inter-Quartile Range|Median
1450931|NCT00845000|Secondary|Mean Peak Tremor Score|Tremor was scored on a scale of 0 (absent), 1 (mild, 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse tremor observed during the time spent with participant while taking other study measurements(vital signs, drawing samples, performing the tapping and walking tasks). Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The tremor score was the sum of scores for seven body parts. The peak tremor score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating more effects of the tremors. The mean peak tremor score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||Score on a scale||Standard Deviation|Mean
1450932|NCT00845000|Secondary|Mean Peak Finger Tapping Score|Tapping was measured with two manual counters with keys that were depressed to register a count. The participant alternately tapped each counter using the index finger of the more affected hand for 60 seconds and was not allowed to use more than one finger to tap. The participant was instructed to tap as rapidly as possible while being timed for 60 seconds. The counts were recorded for the two counters at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The peak tapping score was recorded for each participant regardless of what timepoint the score was achieved. The mean peak finger tapping score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||taps per 60 seconds||Standard Deviation|Mean
1450933|NCT00845000|Primary|Mean Peak Dyskinesia Score|Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.|Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period|All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.|||Score on a scale||Standard Deviation|Mean
1450934|NCT00844896|Primary|Change From Baseline in Burn Outcomes Questionnaire Short Form (5-18 Year Old Version) From Six Months.|Burn Outcomes Questionnaire (American Burn Association/Shriners Hospitals for Children) Short Form (5-18 Year Old Version) is a 3-item questionnaire with scores ranging from 0-18. A higher score is indicative of worse outcomes. Used for five year olds in the study. Change in scores were observed from baseline to six month follow-up.|baseline and six month follow-up|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1450935|NCT00844896|Primary|DEF Participation|Outcomes in this measure were quantified by the number of participants in either intervention (DEF-only or COPE+DEF). During the study, DEF intervention was part of the standard of care for all patients at Shriners Hospitals for Children-Boston and thus every participant in this study had been evaluated using DEF to determine distress, emotional and family support.|Baseline|Intentional to treat (ITT)|||participants|||Number
1450936|NCT00844896|Primary|Change From Baseline in Stanford Acute Stress Reaction Questionnaire at Six Months|Stanford Acute Stress Reaction Questionnaire is a 31-question self-report measure for acute stress in parents. Scores range from 0-155 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
1450937|NCT00844896|Primary|Change From Baseline in Hospital Emotional Support Form From Six Months|Hospital Emotional Support Form is a 12-question form that rates parents/caregivers need for in-hospital emotional support. Scores range from 11-24, with a lower score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
1450938|NCT00844896|Primary|Change From Baseline in PTSD Semi-Structured Interview at Six Months|Posttraumatic Stress Disorder Semi-Structured Interview is based on DSM-IV criteria, with a higher score indicative of increased symptoms of PTSD. The total rating was scored from 19 questions in three clusters of symptoms, with a score range of 0-38. Change in scores were observed from baseline to six month follow-up.|Baseline and six-month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
1450939|NCT00844896|Primary|Change From Baseline in Child Stress Reaction Checklist Short Form at Six Month|Child Stress Reaction Checklist Short Form is a 9-item parent-rated checklist. Scores range from 0-18 with a higher score indicative of worse outcomes. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
1450940|NCT00844896|Primary|Change From Baseline in Parenting Stress Index at Six Months|Parenting Stress Index is a 12-item parent-rated questionnaire which employs a 1-5 Likert scale. Scores range from 12-60, with a lower score indicative of worse outcomes and a cutoff of 15. Change in scores were observed from baseline to six month follow-up.|Baseline and six month follow-up|Intention to treat (ITT)|||units on a scale||Standard Deviation|Mean
1450941|NCT00844896|Primary|Change From Baseline in Pediatric Symptom Checklist at Six Months|Pediatric Symptom Checklist is an 18-item psychosocial checklist in which symptoms are rated from 0 (never) to 2 (often) and the last question is rated as yes or no (0 or 1). Items are summed and the score can range from 0-35, with a higher score indicative of more symptoms and a worse outcome. Change in scores were observed from baseline to six month follow-up|Baseline and six month follow-up|Intention to Treat (ITT)|||units on a scale||Standard Deviation|Mean
1451144|NCT00844376|Primary|Maximum Observed Plasma Concentration (Cmax)|Geometric mean of Cmax = maximum observed plasma concentration of atorvastatin (test vs reference); measured in nanograms per milliliter (ng/mL).|5 days||||ng/mL||Full Range|Geometric Mean
1450945|NCT00844883|Secondary|Efficacy - Median TTP After Combination Treatment With Sorafenib and TACE|"Time to progression (TTP) - defined as the time from initiation of therapy to disease progression (radiological). Median TTP calculated for all subjects and stratified by Barcelona Clinic Liver Cancer (BCLC) staging.~46 patients out of 50 were reviewed for this outcome. 3 patients were excluded because they underwent liver transplantation and 1 patient was excluded for hepatic resection."|3 years|Median TTP stratified by BCLC staging; 3 patients had BCLC stage A disease, 14 with stage B, and 29 with stage C.|||months||Inter-Quartile Range|Median
1450946|NCT00844883|Secondary|Efficacy Assessed by European Association for the Study of the Liver (EASL) Criteria to Determine Response and Disease Control Rate|"Efficacy as assessed by radiographic tumor response using the EASL criteria at baseline and at 6 months post the initiation of treatment.~Complete response (CR): 100% tumor necrosis Partial Response (PR): more than 50% tumor necrosis Progressive Disease (PD): increase in tumor enhancement by more than 25% Stable Disease (SD): Cases that do not qualify for one of the above criteria"|6 months|32 out of the 50 patients had imaging assessable by EASL criteria at 6 months - 18 out of the original 50 had exited prior to this time point or did not have applicable imaging.|||Participants|||Count of Participants
1450947|NCT00844883|Secondary|Efficacy Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) to Determine Response and Disease Control Rate|"Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6 months post the initiation of treatment. 33 out of the original 50 patients were evaluable at this time point, with 17 out of the 50 exiting prior to 6 months or were not assessable by RECIST criteria.~Complete response (CR): Disappearance of all lesions targeted with therapy Partial Response (PR): at least 30% decrease in sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): at least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD"|6 months|33 out of the original 50 patients were evaluable for this outcome, with 17 out of the original 50 exiting prior to 6 months or were not assessable by RECIST criteria.|||Participants|||Count of Participants
1450948|NCT00844883|Primary|Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.|Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more.|2 years (Cycles 2-5+)|39 patients were reviewed for toxicities for Cycle 2-5+. 11 patients out of the original 50 exited the study prior to Cycle 2.|||# of participants with adverse events|||Number
1450949|NCT00844883|Primary|Safety Will be Assessed by Grading Toxicities Reported at Intervals Throughout the Study. Higher Grade Toxicities Will be Assessed for Their Degree of Relatedness to the Study Treatment.|Treatment toxicities assessed by CTCAE v3.0 were stratified by cycle - patients on Cycle 1, and patients on Cycles 2-5 or more. 50 patients were reviewed for toxicities for Cycle 1, and all 50 patients experienced at least one adverse event during this time period.|6 weeks (Cycle 1)||||# of participants with adverse events|||Number
1450950|NCT00844857|Other Pre-specified|Change From Baseline in Electrocardiogram (ECG) QTcF Interval Up to Week 8|QTcF is defined as ECG QT interval corrected for heart rate using the Fridericia correction factor.|Baseline, Week 8|Population analyzed M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and QTcF at baseline and at least 1 post-baseline measurement; LOCF.|||millisecond (msec)||Standard Error|Least Squares Mean
1450951|NCT00844857|Other Pre-specified|Change From Baseline in Prolactin Up to Week 8|Prolactin LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and prolactin at baseline and at least 1 post-baseline measurement; LOCF.|||microgram/Liter (μg/L)||Standard Error|Least Squares Mean
1450952|NCT00844857|Other Pre-specified|Change From Baseline in Alanine Aminotransferase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) Up to Week 8|ALT/SGPT LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ALT/SGPT at baseline and at least 1 post-baseline measurement; LOCF.|||units/Liter (U/L)||Standard Deviation|Least Squares Mean
1450953|NCT00844857|Other Pre-specified|Change From Baseline in Fasting Metabolic Parameters Up to Week 8|Fasting glucose, fasting cholesterol and fasting triglycerides. LS means were adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and fasting glucose, cholesterol and triglycerides at baseline and at least 1 post-baseline measurement; LOCF.|||millimoles/liter (mmol/L)||Standard Error|Least Squares Mean
1450954|NCT00844857|Other Pre-specified|Change From Baseline in Weight Up to Week 8|Weight LS mean was adjusted for baseline and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and weight at baseline and at least 1 post-baseline measurement; LOCF.|||kilogram (kg)||Standard Error|Least Squares Mean
1450955|NCT00844857|Other Pre-specified|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Kid and Kiddo Combined Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Kid-KINDL was administered to ages 8-11 and Kiddo-KINDL to ages 12-16. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites and had KINDL Kid and Kiddo results at baseline and at least 1 post-baseline measurement. Due to small number of 10- and 11-year olds results from the 2 versions were pooled; LOCF.|||units on a scale||Standard Error|Least Squares Mean
1450994|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 52|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.|||Units on a Scale||Inter-Quartile Range|Median
1450956|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Dyskinesia Up to Week 8|Dyskinesia was measured using the Abnormal Involuntary Movement Scale (AIMS) a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale: 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 11 and 12 are yes/no questions regarding the dental condition of a patient. Total score (0-40) is obtained by adding the scores of the first 10 items. An abnormal result is defined as having a score ≥3 for at least 1 of the first 7 items or a score ≥2 for at least two of the first 7 items.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
1450957|NCT00844857|Other Pre-specified|Percentage of Participants With at Least One Treatment-Emergent Incident of Parkinsonism Up to Week 8|Parkinsonism was measured using the Simpson-Angus Scale with a total scores range from 0 to 40. A score > 3 was considered abnormal. Simpson-Angus Scale consists of 10 items, each rated on a 5-point scale, 0 (complete absence of the condition) to 4 (presence of the condition in extreme form).|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
1450958|NCT00844857|Secondary|Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8|The KINDL consists of 24 Likert-scale items. Total scores were standardized to a 0 (lowest quality of life) to 100 (highest quality of life). LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and KINDL Parent Scale at baseline and at least 1 post-baseline measurement; LOCF.|||units on a scale||Standard Error|Least Squares Mean
1450959|NCT00844857|Secondary|Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8|Attention Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS-IV-PI): Investigator Administered and Scored measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Scores range: 0 to 54. The LS mean was adjusted for baseline and treatment.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and ADHDRS-IV-PI results at baseline and at least 1 post-baseline measurement; LOCF.|||units on a scale||Standard Error|Least Squares Mean
1450960|NCT00844857|Secondary|Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8|Worsening of mania was defined as YMRS score of ≥20 and a CGI severity of mania score of ≥ 5 at the same visit. The YMRS is an 11-item scale measuring severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) with remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. CGI measures severity of the participant's overall severity of bipolar symptoms and scores range from 1 (normal) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites with YMRS and CGI total scores at baseline and at least 1 post-baseline measurement; LOCF.|||percentage of participants|||Number
1450961|NCT00844857|Secondary|Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8|"Columbia-Suicide Severity Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Percentage of participants with suicidal ideation, behavior, and acts are provided. Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
1450962|NCT00844857|Secondary|Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8|Akathisia was measured using the Barnes Akathisia Rating Scale where the global scores range from 0 (absent) to 5 (severe) and a score ≥ 2 is considered abnormal.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug excluding participants from 2 GCP noncompliant sites; LOCF.|||percentage of participants|||Number
1450963|NCT00844857|Secondary|Change From Baseline in the CDRS-R Total Score Up to Week 8|CDRS-R Total score measure the presence and severity of depression in children and consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Total scores range from 17 to 113. In general, scores < 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. LS mean was adjusted for baseline, country, and treatment.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had CDRS-R total scores at baseline and at least 1 post-baseline measurement; LOCF.|||units on a scale||Standard Error|Least Squares Mean
1450964|NCT00844857|Secondary|Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8|CGI-BP measures severity of illness for bipolar illness. Scores range: 1 (normal, not ill at all) to 7 (among the most extremely ill patients). LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had CGI-BP total scores at baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1451145|NCT00844376|Secondary|Area Under the Curve From Predose (Time Zero) to Last Quantifiable Concentration (AUClast)|Geometric mean of AUClast = area under the plasma concentration-time curve from time zero (0) to the last measurable concentration of atorvastatin (test vs reference); measured as ng.hr/mL|5 days||||ng.hr/mL||Full Range|Geometric Mean
1450965|NCT00844857|Secondary|Change From Baseline in the YMRS Total Score at Week 8|The YMRS is an 11-item scale measuring the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total scores ranges: 0 to 60. LS mean was adjusted for baseline, country, treatment, visit, and treatment * visit interaction.|Baseline, Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites who had YMRS total scores with a baseline and at least 1 post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1450966|NCT00844857|Secondary|Percentage of Participants in Each Improvement Category Up to Week 8|CDRS-R scores: No/low improvement is < 25 percent (%) of maximum reduction from baseline. Mild improvement: maximum reduction from baseline on CDRS-R score ≥ 25% up to <50% and YMRS elevated mood score ≤ 2. Moderate improvement: maximum reduction from baseline on CDRS-R score ≥50% and <75% and YMRS elevated mood score ≤ 2. Major improvement: maximum reduction from baseline on CDRS-R score ≥75% and YMRS elevated mood score ≤ 2. CDRS-R measures presence/severity of depression in children. Scale is 17 items scored 1-to-5- or 1-to-7. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores < 20 absence of depression, scores 20 to 30 borderline depression, scores 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures severity of manic episodes. Four items rated 0 (symptoms not present) to 8 (symptom extremely severe). Remaining items rated 0 (symptoms not present) to 4 (symptom extremely severe). Score range: 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both CDRS-R and YMRS total scores with a baseline and at least 1 post-baseline measurement; LOCF.|||percentage of participants|||Number
1450967|NCT00844857|Secondary|Percentage of Participants With Response Up to Week 8|Response is defined as a CDRS-R total score greater than or equal to (≥)50% reduction from baseline and YMRS elevated mood score ≤2. CDRS-R Total score measure the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. In general, <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had all of CDRS-R and YMRS total scores at baseline and at least 1 post-baseline measurement; LOCF|||percentage of participants|||Number
1450968|NCT00844857|Secondary|Percentage of Participants With Remission Up to Week 8|Remission is defined as a CDRS-R total score less than or equal to (≤)28, and Young Mania Rating Scale (YMRS) total score ≤ 8 and Clinical Global Impressions-Bipolar Version (CGI-BP) total score ≤3. CDRS-R is a 17-item scale measuring presence/severity of depression in children and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. Scores range: 17 to 113. Scores <20 indicate an absence of depression, scores 20 to 30 indicate borderline depression, scores 40 to 60 indicate moderate depression. The YMRS is an 11-item scale measuring severity of manic episodes; 4 items are rated on a scale from 0 (symptoms not present) to 8 (symptom extremely severe) with remaining items rated on a scale from 0 (symptoms not present) to 4 (symptom extremely severe). YMRS score ranges from 0 to 60. CGI-BP measures participant's overall severity of bipolar symptoms. Scores range: 1 (normal, not at all ill ) to 7 (among the most extremely ill participants).|Baseline up to Week 8|Population analyzed was the M-ITT Population: all randomized participants who took at least 1 dose of study drug and excluding participants from 2 GCP noncompliant sites and who had both the CDRS-R, YMRS and CGI-BP total scores at baseline and at least 1 post-baseline measurement; Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1450969|NCT00844857|Primary|Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8|CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (*) visit interaction.|Baseline, Week 8|Population analyzed was the Modified Intention-to-Treat (M-ITT) Population: defined as all randomized participants who took at least 1 dose of study drug and excluding participants from 2 Good Clinical Practice (GCP) noncompliant sites and who had a baseline and at least 1 post-baseline CDRS-R measurement.|||units on a scale||Standard Error|Least Squares Mean
1450970|NCT00844844|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mil||Standard Deviation|Mean
1450971|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
1450985|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS-40 response was defined as ASAS achieving ≥40% improvement in 3 of the 4 domains (patient global assessment, total back pain, function, and inflammation), with an absolute improvement of ≥20 mm and no deterioration in the remaining domain.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Percentage of Participants|||Number
1450972|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1450973|NCT00844844|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1450974|NCT00844844|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1450975|NCT00844844|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1450976|NCT00844844|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
1450977|NCT00844844|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥ 25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1450978|NCT00844844|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1450979|NCT00844844|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1450980|NCT00844844|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study visit for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1450981|NCT00844831|Secondary|Small Intestinal Bacterial Overgrowth (SIBO)|SIBO was measured before and after treatment.|28 days||||participants|||Number
1450982|NCT00844831|Secondary|Small Bowel and Colon Transit Time by SmartPill® Transit Study||28 days|We were unable to obtain the smart pills for this section of the protocol.||||||
1450983|NCT00844831|Primary|Presence of Small Intestinal Bacterial Overgrowth|Percent of patients with bacterial overgrowth before and after treatment.|28 days|ITT|||Participants|||Count of Participants
1450984|NCT00844805|Secondary|Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase|"ASAS-20 response was defined as ≥20% improvement in response according to following criteria:~• An improvement of ≥20% from baseline and an absolute improvement from~baseline of ≥10 mm in at least 3 of the following 4 domains (patient global assessment, pain, function,and inflammation)~• Absence of deterioration from baseline (≥20% and an absolute change of~≥10 mm) in the potential remaining domain."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Percentage of Participants|||Number
1451564|NCT00841776|Secondary|Median Change in Clindamycin Resistant P. Acne.|Median change in total colony forming units of clindamycin resistant p. acne.|Baseline, Weeks 2, 4, 8, 12, 16|ITT|||Clindamycin- resistant P. acne counts||Inter-Quartile Range|Median
1450986|NCT00844805|Secondary|Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase|"The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) employs a VAS of 0mm (best) to 100mm (worst). Disease flare was defined as reaching a BASDAI of ≥30 mm during two consecutive visits after Week 28 until Week 52.~ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria was defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation)."|Week 52|The Intent-to-Treat Population consisted of all subjects who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1450987|NCT00844805|Secondary|Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized to treatment, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Weeks||Full Range|Median
1450988|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active spinal inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1450989|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52|EaEach sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1450990|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 52|The Intent-to-Treat Population consisted of all participants that were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1450991|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28|"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0."|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1450992|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions at the sacroiliac joints was defined as a Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1450993|NCT00844805|Secondary|Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1455050|NCT00814164|Secondary|Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
1450995|NCT00844805|Secondary|Change From Baseline of Berlin MRI Spine Overall Score at Week 52|MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 52|The number of participants represents those with a Week 28 values and those with a Week 52 value.|||Units on a Scale||Inter-Quartile Range|Median
1450996|NCT00844805|Secondary|Change From Baseline in the Sacroiliac Overall Score at Week 28|Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.|||Units on a Scale||Inter-Quartile Range|Median
1450997|NCT00844805|Secondary|Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28|MRI scans (T1 for chronic changes and short tau inversion recovery [STIR] for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable.|Baseline, Week 28|The number of participants represented those with a screening value and a value at treatment Week 28.|||Units on a Scale||Inter-Quartile Range|Median
1450998|NCT00844805|Secondary|Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Percentage of Participants|||Number
1450999|NCT00844805|Secondary|Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase|ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 52|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1451000|NCT00844805|Primary|Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28|ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation).|Week 28|The Intent-to-Treat Population consisted of all participants who were randomized, took at least one dose of study medication, and had at least one post-baseline efficacy assessment.|||Participants|||Number
1451001|NCT00844753|Primary|Percentage of Participants Who Were Autism Spectrum Disorder Respondents|"Respondents were defined as having ≥30% decrease on the HSQ and CGI-I≤2). The 25-item HSQ was adapted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate behavioral noncompliance in children with autism spectrum disorder (ASD). The Home Situations Questionnaire – Pervasive Developmental Disorder (HSQ) is a 25-item parent rating scale assessing noncompliance. Parents are asked to indicate whether each item is a problem and, if so, its severity from 1 (mild) to 9 (severe). The School Situations Questionnaire (SSQ) is a 9-item teacher rating scale that assesses noncompliance. The SSQ is a companion instrument to the HSQ and uses the same rating scale.~The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill),"|week 10||||percentage of participants|||Number
1451002|NCT00844753|Primary|Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents|Respondents were defined as having ≥30% decrease on the SNAP and CGI-I<=2). The Swanson, Nolan, and Pelham (SNAP)–IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), with a rating of ≥4 required for inclusion. The Improvement score ranged from 1 (very much improved) through 4 (no change) to 7 (very much worse). The CGI was completed by a blinded rater based on parent/child interview and review of completed parent and school behavior problem questionnaires at each study visit.|week 10||||percentage of participants|||Number
1451003|NCT00844714|Primary|Flow-mediated Vasodilation (FMD)|endothelial function as assessed by flow-mediated vasodilation of the brachial artery|12 weeks, 24 weeks||||percentage change in diameter||Inter-Quartile Range|Median
1451004|NCT00844649|Other Pre-specified|Number of Participants With Dose Delays/Doses Not Given|The number of dose delays or doses not given experienced by participants during the treatment period. Dose delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities. Treatment delays of no longer than 21 days allowed participants to recover from acute toxicity, otherwise participants were discontinued from further treatment except in the event of peripheral neuropathy.|Up to 666 days|Treated Population|||number of dose delays|||Number
1451005|NCT00844649|Other Pre-specified|Number of Participants With Dose Interruptions|The number of participants with dose interruptions experienced by participants that occurred during the treatment period. Dose interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|Maximum time on treatment was 666 days|Safety population, includes participants who received at least one study treatment|||participants|||Number
1451007|NCT00844649|Other Pre-specified|Participants With Treatment Emergent Adverse Events (AE)|A Treatment Emergent Adverse Event (TEAE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.|Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 696 days|Treated patient population|||participants|||Number
1451008|NCT00844649|Secondary|Percentage of Participants Who Achieved an Objective Confirmed Overall Response by Independent Radiological Review (IRR)|Objective tumor response was summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) based on an independent blinded radiology assessment of response using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Using RECIST Version 1.0, participants were to achieve either a complete response (CR) defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response (PR) defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the investigator assessment of best overall response during study treatment.|Assessment every 4 weeks after initial response; Day 1 to data cut off of 17 Sept 2013; maximum time on study 37 months|Intent to Treat population (ITT population) consisted of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1451009|NCT00844649|Secondary|Progression-free Survival (PFS) by Independent Radiological Review (IRR)|Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment, on or prior to the clinical cutoff, and the patient was progression free. If a patient began a new anti-cancer treatment prior to documented disease progression (or death), the patient was censored at the date of last assessment when the patient was documented as progression free prior to the intervention. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.|Randomization until disease progression or death from any cause; Until the data cut off of 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.|||months||95% Confidence Interval|Median
1451010|NCT00844649|Primary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization to the date of death from all causes. Participants who did not die were censored at the last known time the participant was alive. Patient survival was summarized using Kaplan-Meier methods.|From randomization to death; until the data cut off 17 Sept 2012. The maximum time in follow up was 37 months.|Intent to Treat population (ITT population) consisted of all randomized participants.|||months||95% Confidence Interval|Median
1451011|NCT00844597|Post-Hoc|Adverse Events >15%|Adverse events that occurred in >15% of overall patient population across dose level arms.|27 Weeks|Safety Population|||Events|||Number
1451012|NCT00844597|Primary|Treatment Emergent Adverse Events|Number of Patients with Treatment Emergent Adverse Events|from Baseline to Follow up (27 weeks)|Safety Population|||participants|||Number
1451013|NCT00844597|Secondary|Efficacy of Eteplirsen Over 12 Weeks of Dosing|Efficacy was defined as an estimated change in the percentage of dystrophin positive fibers (assessed by IHC) at Week 14 from Baseline after 12 weekly doses of eterplirsen. This outcome measure represents the number of patients to show an increase in the percentage of dystrophin-positive fibers.|Biopsies were taken at Baseline and Week 14|Per Protocol Population - Included all patients who received all 12 doses of study treatment.|||participants|||Number
1451014|NCT00844597|Secondary|Pharmacokinetics - Mean Peak Plasma Concentration of AVI-4658 After Administration|Standard Pharmacokinetic parameters estimated using non-compartmental modeling of plasma concentration data.|Samples were taken: 30 minutes pre dose; and at 5 (±1), 15 (±2), 30 (±5), 60 (±5), and 90 (±5) minutes; and 2, 4, 6, 8, 12, and 24 hours (all ± 15 minutes) post dose at Weeks 1, 6, and 12|PK Evaluable Population: Included all patients who provided at least 1 PK sample. The reportable PK population included those patients with at least Cmax, Tmax, and AUC0-24 computed from 1 or more of the 3 sampling days (1st, 6th, 12th dose [Weeks 1, 6, and 12]).|||ng/mL||Standard Deviation|Mean
1451015|NCT00844597|Primary|Safety and Tolerability|Number of subjects with 1 or more Treatment Emergent Adverse Event that are possibly related to the investigational drug|Baseline to 6 months|Safety Population - Any patient who received at least one dose of the study drug.|||participants|||Number
1451016|NCT00844558|Secondary|Change in Chair Stand Time|Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.|0,3,6,and 12 months||||seconds||95% Confidence Interval|Mean
1451017|NCT00844558|Secondary|Change in Stair Climb Time, Secs|Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm)|0,3,6, and 12 months||||seconds||95% Confidence Interval|Mean
1451018|NCT00844558|Secondary|Change in Long Distance Corridor Walk (LDCW) Time, Secs|The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale.|0,3,6 and 12 months||||seconds||95% Confidence Interval|Mean
1451019|NCT00844558|Secondary|Change in KOOS Symptoms|"This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.~Scored from 0 to 100 with 100 indicating no symptoms."|0,3,6 and 12 months||||units on a scale||95% Confidence Interval|Mean
1451020|NCT00844558|Secondary|Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain|"This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods.~Scored from 0 to 100 with 100 indicating no pain."|0,3,6 and 12 months||||units on a scale||95% Confidence Interval|Mean
1451021|NCT00844558|Primary|Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument|"This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities.~Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance)."|0,3,6, and 12 months||||units on a scale||95% Confidence Interval|Mean
1451022|NCT00844545|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data|||micrograms/mil||Standard Deviation|Mean
1451023|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of the study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of the study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 100.29 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
1451024|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of the study was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1451025|NCT00844545|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451026|NCT00844545|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through End of Study, Median Exposure 100.29 Weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through end of the study were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451027|NCT00844545|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1451028|NCT00844545|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||# events/patient/day||Standard Deviation|Mean
1451029|NCT00844545|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as as ≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1451030|NCT00844545|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451031|NCT00844545|Primary|Percentage of Patients With Platelet Count Normalization|The primary objective of the study (per protocol) was to assess the effect of eculizumab to reduce TMA as measured by platelet count change from baseline (BL) during the Treatment Period (26 weeks) in patients with plasma therapy (PT)-resistant aHUS (protocol defined), including assessment of the proportion of patients who achieved Platelet Count Normalization from baseline through 26 weeks. Platelet Count Normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks.|Through 26 weeks|The Tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451032|NCT00844545|Primary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1451033|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1451034|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1451035|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1451036|NCT00844532|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1451037|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1451038|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1451039|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
1451040|NCT00844532|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient’s point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
1451041|NCT00844532|Secondary|Stent Thrombosis|Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
1451042|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451043|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451044|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery|18 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451045|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451046|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
1451047|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
1451048|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
1451049|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of limbs|Participants||Number
1451050|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451051|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451052|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451053|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451054|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|3 years|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451055|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451056|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|18 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451057|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
1451058|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
1451059|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
1451060|NCT00844532|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
1451061|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1451062|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1451063|NCT00844532|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
1451565|NCT00841776|Primary|Median Change in Total Propionibacterium Acne (P.Acne) Counts|Median change in total colony forming units of propionibacterium acne (P.acne) will be counted.|Baseline, Weeks 2, 4, 8, 12, & 16||||P. acne counts||Inter-Quartile Range|Median
1451065|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population.This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
1451066|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
1451067|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
1451068|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.|||percentage of limbs|Participants||Number
1451069|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451070|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451071|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451072|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451073|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|3 years|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451074|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|2 years|ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451075|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|18 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451608|NCT00841204|Secondary|Sulindac Effects on Apoptosis in Atypical Nevi|Change in the expression of a marker of apoptosis, cleaved caspase 3, in melanocytic junctional component|Baseline and 8 weeks||||% of stained cells * intensity score||Inter-Quartile Range|Median
1451076|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)|1 month and 9 months|ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.|||percentage of target vessels|Participants||Number
1451077|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451078|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451079|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451080|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451081|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451082|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451083|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451084|NCT00844532|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
1451085|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451086|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451087|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451088|NCT00844532|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451089|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451090|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451091|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451092|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451093|NCT00844532|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percentage of Limbs|Participants||Number
1451094|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
1451095|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ)|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
1451110|NCT00844532|Secondary|Procedure Success|Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population|||percentage of participants||95% Confidence Interval|Number
1451096|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
1451097|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||scores on a scale||Standard Deviation|Mean
1451098|NCT00844532|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|Pre-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||score on a scale||Standard Deviation|Mean
1451099|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451100|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451101|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|9 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451102|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451103|NCT00844532|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Post-procedure|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451104|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451105|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451106|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451107|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|Per target limb analysis.ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451108|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451109|NCT00844532|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
1451112|NCT00844532|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|acute: from beginning of index procedure to end of index procedure.|Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.|||percentage of devices|Participants|95% Confidence Interval|Number
1451113|NCT00844532|Primary|Major Adverse Event (MAE) Rate|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants||95% Confidence Interval|Number
1451114|NCT00844519|Primary|Percent Change in FMD|endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery|Baseline, 24 weeks||||percent change in FMD||Standard Deviation|Mean
1451115|NCT00844480|Secondary|BMD at Other Skeletal Sites|BMD at spine, femoral neck, distal femur, proximal tibia, heel|6 months|heel measurements were not performed|||percentage of baseline BMD||Standard Deviation|Mean
1451116|NCT00844480|Primary|Bone Mass Density (BMD) at Total Hip|bone mineral density measured by DXA at the total hip|6 months||||%change in BMD from baseline||Standard Deviation|Mean
1451117|NCT00844428|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.|||micrograms/mil||Standard Deviation|Mean
1451118|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451119|NCT00844428|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1451120|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
1451121|NCT00844428|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1451122|NCT00844428|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451123|NCT00844428|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451124|NCT00844428|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451125|NCT00844428|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1451146|NCT00844376|Primary|Area Under the Curve From Predose (Time Zero) to Extrapolated Infinite Time (AUC Infinity)|Geometric means of AUC infinity (AUCinf) = area under the plasma concentration-time curve from time zero (0) extrapolated to infinite time; measured in ng.hr/mL of atorvastatin (test vs reference).|5 days||||ng.hr/mL||Full Range|Geometric Mean
1451126|NCT00844428|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
1451127|NCT00844428|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1451128|NCT00844428|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451129|NCT00844428|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451130|NCT00844415|Secondary|Occurences of Clinical Outcome|Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location). Number of patients with particular clinical outcome are reported.|3 days|TS|||Participants|||Number
1451131|NCT00844415|Secondary|Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs|Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.|Baseline and 3 days|TS|||Participants|||Number
1451132|NCT00844415|Secondary|Ecarin Clotting Time (ECT)|Measurement of ECT was performed locally and centrally using validated assays. Descriptive statistics is only performed for the centrally measured ECT.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
1451133|NCT00844415|Secondary|aPTT Locally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
1451134|NCT00844415|Secondary|Activated Partial Thromboplastin Time (aPTT) Centrally Measured|Measurement of aPTT was performed locally and centrally using validated assays.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
1451135|NCT00844415|Primary|TT Locally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
1451136|NCT00844415|Primary|Thrombin Time (TT) Centrally Measured|Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.|Day 3|TS with non-sparse data|||seconds||Standard Deviation|Mean
1451137|NCT00844415|Primary|Plasma Concentration of Total Dabigatran|Plasma concentration of total dabigatran measured at 72 hours after first dose|Day 3|TS with non-sparse data|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1451138|NCT00844415|Primary|Plasma Concentration of Free Dabigatran|Plasma concentration of free dabigatran measured at 72 hours after first dose|3 days|Treated Set. Descriptive statistics for the concentration measurement could only be calculated for the subgroups of patients receiving the same sequence of doses. Statistics were only reported for groups with at least 3 patients (non-sparse data).|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1451139|NCT00844415|Primary|Number of Patients With Adverse Events|Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period. Events were considered „on-treatment“ if occurring within 72 hours after last drug administration.|From Screening until 30 days after first drug administration (end of trial visit)|TS|||Participants|||Number
1451140|NCT00844415|Primary|Number of Patients With Bleeding Events (Major and Minor)|"Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria:~Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds."|From Screening until 30 days after first drug administration (end of trial visit)|Treated set (TS). This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||Participants|||Number
1451141|NCT00844376|Secondary|Plasma Elimination Half-life (t1/2)|Mean of t1/2 = terminal elimination half-life of atorvastatin (test vs reference); measured in hours.|5 days||||hr||Standard Deviation|Mean
1451142|NCT00844376|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Median of Tmax = time to maximum plasma concentration (Cmax) (test vs reference); measured in hours (hr).|5 days||||hr||Full Range|Median
1451143|NCT00844376|Secondary|Terminal Phase Rate Constant (Kel)|Geometric mean of Kel= termination phase rate constant for atorvastatin (test vs reference); measured as 1 per hour (1/hr).|5 days||||1/hr||Full Range|Geometric Mean
1451151|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451152|NCT00844194|Secondary|Change of Pulse Rate From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
1451153|NCT00844194|Secondary|Change of Diastolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1451154|NCT00844194|Secondary|Change of Systolic Blood Pressure From Baseline at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1451155|NCT00844194|Secondary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of HbA1c at baseline and at week 12.|||percent||95% Confidence Interval|Least Squares Mean
1451156|NCT00844194|Secondary|Change of Fasting Blood Glucose From Baseline at Week 12|Ancova analysis controlling for baseline and insulin intake|Baseline and Week 12|All patients receiving at least one dose of study medication and having data of fasting blood glucose at baseline and at week 12.|||mg/dL||95% Confidence Interval|Least Squares Mean
1451157|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.|||Participants|||Number
1451158|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.|||Participants|||Number
1451159|NCT00844194|Secondary|Suicidal Thoughts or Behaviours by HAMD-17 at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.|||Participants|||Number
1451160|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 12||Week 12|All patients receiving at least one dose of study medication and having data at week 12.|||Participants|||Number
1451161|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 6||Week 6|All patients receiving at least one dose of study medication and having data at week 6.|||Participants|||Number
1451162|NCT00844194|Secondary|Suicidal Thoughts by BDI-II at Week 2||Week 2|All patients receiving at least one dose of study medication and having data at week 2.|||Participants|||Number
1451163|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451164|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores of a scale||Standard Deviation|Mean
1451165|NCT00844194|Secondary|Change in Hamilton Depression Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451166|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 12||||Scores of a scale||Standard Deviation|Mean
1451167|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451168|NCT00844194|Secondary|Change in Clinical Global Impression - Severity Pain From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451169|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12|Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451170|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6|Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451198|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451171|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12|Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451172|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6|Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451173|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451174|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6|Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451175|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12|Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451176|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6|Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451177|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451178|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6|Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451179|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451180|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6|Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451181|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451182|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6|Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451183|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451184|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6|Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451185|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451186|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6|Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451187|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451188|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451189|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451190|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6|Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451191|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451192|NCT00844194|Secondary|Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6|Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451193|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451194|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451195|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451196|NCT00844194|Secondary|Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451197|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451199|NCT00844194|Secondary|Change in HADS Depression Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451200|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451201|NCT00844194|Secondary|Change in HADS Anxiety Total Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451202|NCT00844194|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451203|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451204|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451205|NCT00844194|Secondary|Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451206|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 12|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451207|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 6|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451208|NCT00844194|Secondary|Patient Global Impression - Improvement (PGI-I) at Week 2|The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451209|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451210|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451211|NCT00844194|Secondary|Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451212|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451213|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451214|NCT00844194|Secondary|Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451215|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451216|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451217|NCT00844194|Secondary|Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451218|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451219|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451220|NCT00844194|Secondary|Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451221|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451222|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451223|NCT00844194|Secondary|Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451224|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451225|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451226|NCT00844194|Secondary|Change in Interference of Pain With Mood (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451227|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451261|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and 72 as Assessed by Urine Creatinine Clearance|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451228|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451229|NCT00844194|Secondary|Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451230|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12|The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||scores on a scale||Standard Deviation|Mean
1451231|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6|The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||scores on a scale||Standard Deviation|Mean
1451232|NCT00844194|Secondary|Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2|The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||scores on a scale||Standard Deviation|Mean
1451233|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 12|The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451234|NCT00844194|Secondary|Change in Pain (BPI) From Baseline to Week 6|The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451235|NCT00844194|Secondary|Change in Pain During Treatment (BPI) From Baseline to Week 2|The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451236|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 12||Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Participants|||Number
1451237|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 6||Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Participants|||Number
1451238|NCT00844194|Secondary|Number of Patients With a Reduction in BPI Average Pain at Week 2||Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Participants|||Number
1451239|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451240|NCT00844194|Secondary|Change in Average Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451241|NCT00844194|Secondary|Change in Average Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451242|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451243|NCT00844194|Secondary|Change in Least Pain During Treatment (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1452248|NCT00835367|Primary|Cmax - Benazepril|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451244|NCT00844194|Secondary|Change in Least Pain (BPI) From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451245|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451246|NCT00844194|Secondary|Change in Worst Pain (BPI) From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451247|NCT00844194|Secondary|Change in BPI Worst Pain During Treatment From Baseline to Week 2|The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).|Baseline and Week 2|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451248|NCT00844194|Secondary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6|The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 6|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451249|NCT00844194|Primary|Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12|The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).|Baseline and Week 12|All patients receiving at least one dose of study medication, having any efficacy data and dosage of duloxetine was not more than 60mg before visit 5|||Scores on a scale||Standard Deviation|Mean
1451250|NCT00844090|Primary|Change in HbA1c Over Baseline|measure of longer term glycemic control. A1c measured at baseline 6 weeks and 6 months|6 months from baseline|per protocol|||percentage of HbA1c||Standard Deviation|Median
1451251|NCT00844051|Secondary|Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year||||days per 100 school days||Standard Deviation|Mean
1451252|NCT00844051|Primary|Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs||1 year||||flu+ per 1000 children|||Number
1451253|NCT00843986|Secondary|Total Urine Output at Hours 6, 12, 24, 48 and 72|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|6 Hours, 12 Hours, 24 Hours, 48 Hours and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451254|NCT00843986|Secondary|Total Loop Diuretic Use Through 48 Hours|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451255|NCT00843986|Secondary|Change From Baseline in Body Weight at Hours 24, 48 and 72 and Days 6 and 9 (or Day of Discharge)|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Baseline, 24 Hours, 48 Hours, 72 Hours, Day 6 and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451256|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Provocative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~The Provocative Dyspnea Assessment assesses dyspnea and changes in dyspnea from Baseline on a 5-point Likert scale at 5 different positions and assigns a Dyspnea Severity Score that ranges from 1 (worst severity) to 25 (least severity).~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451257|NCT00843986|Secondary|Assessment of Dyspnea at Baseline, Hours 6, 12, 24 and 48 Using a Relative Dyspnea Assessment|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~Changes in Dyspnea were assessed using the following 7-point Likert scale:~1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 6 Hours, 12 Hours, 24 Hours and 48 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451258|NCT00843986|Secondary|Termination of Study Drug Due to an Adverse Event or Intolerability|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|48.5 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451259|NCT00843986|Secondary|Incidence of Use of Rescue Therapy or Other Intervention (Including Dialysis) Because of Worsening Renal Function|Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination.|Day 9|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451260|NCT00843986|Secondary|Change in Renal Function From Baseline at Hours 24, 48 and Day 9 (or Day of Discharge) as Assessed by Serum Creatinine Concentration and Calculated Creatinine Clearance|"Calculated creatinine clearance is only calculated through hour 72 using the MDRD equation.~MDRD = Modification of Diet in Renal Disease~The MDRD equation is a standard calculation for estimated glomerular filtration rate.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline, 24 Hours, 48 Hours and Day 9|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451609|NCT00841204|Primary|Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis|||µg/g tissue||Standard Deviation|Mean
1451262|NCT00843986|Primary|Assessment of Dyspnea at 24 Hours as Determined by a 7-point Likert Scale|"Dyspnea is defined as the sensation of uncomfortable or difficult breathing.~Changes in Dyspnea were assessed using the following 7-point scale: 1-Markedly worse; 2-Moderately worse; 3-Mildly worse; 4-No change; 5-Mildly improved; 6-Moderately improved; 7-Markedly better/improved.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|24 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451263|NCT00843986|Primary|Change in Renal Function From Baseline at 72 Hours Assessed by Calculated Creatinine Clearance (MDRD Equation)|"MDRD = Modification of Diet in Renal Disease~The MDRD equation is a standard calculation for estimated glomerular filtration rate.~Outcome Measures were not analyzed due to the abbreviated enrollment at early study termination."|Baseline and 72 Hours|Study was terminated – assessment of this Outcome Measure was not performed.||||||
1451264|NCT00843843|Secondary|Psychomotor Vigilance|Fastest 10% reaction time (msec)|after short or long nights|Means|||msec||Standard Deviation|Mean
1451265|NCT00843843|Primary|Dim Light Melatonin Onset (Hours)|Gold standard marker of circadian timing|12 days from baseline to final dim light melatonin onset||||hours||Standard Deviation|Mean
1451266|NCT00843830|Secondary|Number of Patients That Respond to Treatment|To evaluate the anti-tumor response as determined by RECIST criteria|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.||||||
1451267|NCT00843830|Primary|The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.|The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.|10 weeks|The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.||||||
1451268|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 12|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451269|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 10|Of the 130 subjects in the Full Analysis Set, 37 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451270|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 8|Of the 130 subjects in the Full Analysis Set, 34 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451271|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 6|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451272|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 4|Of the 130 subjects in the Full Analysis Set, 35 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451273|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 2|Of the 130 subjects in the Full Analysis Set, 36 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451274|NCT00843778|Secondary|Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0|The ISRQ is scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Scores range from 0 to 10. Subjects receiving hospital nurse injection at this visit completed the ISRQ questionnaire.|Week 0|Of the 130 subjects in the Full Analysis Set, 31 subjects are included in the analysis of this outcome measure, based upon the number of subjects receiving hospital nurse injection at this visit, with an available assessment score at the visit.|||units on a scale||Standard Deviation|Mean
1451275|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 12|Of the 130 subjects in the Full Analysis Set, 74 or 75 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1452284|NCT00835185|Secondary|CL at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, CL results were not collected.||||||
1451276|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 10|Of the 130 subjects in the Full Analysis Set, 72, 73 or 74 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1451277|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 8|Of the 130 subjects in the Full Analysis Set, 78, 79 or 80 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1451278|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 6|Of the 130 subjects in the Full Analysis Set, 66, 67 or 68 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1451279|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 4|Of the 130 subjects in the Full Analysis Set, 82 or 83 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1451280|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 2|Of the 130 subjects in the Full Analysis Set, 80 or 81subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1451281|NCT00843778|Secondary|Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The six domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 65 or 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1451282|NCT00843778|Secondary|Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0|The three domains of the PRE SIAQ are feelings about injections, self-confidence, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting completed this pre-self-injection questionnaire. The PRE-SIAQ is taken before the subject's first injection.|Week 0 of this study (C87080 [NCT00843778])|Of the 130 subjects in the Full Analysis Set, 66 subjects are included in the analysis of each subscale measure, based upon the number of subjects self-injecting at the visit, with the available subscale score at the visit. For each subscale of the questionnaire, N, Mean and SD are presented for non-missing values.|||units on a scale||Standard Deviation|Mean
1451283|NCT00843778|Secondary|Percentage of Subjects Willing to Self-inject at Week 0|The percentage of subjects willing to self-inject at Week 0 will be presented using the Full Analysis Set.|Week 0 of this study (C87080 [NCT00843778])|Full Analysis Set|||percentage of participants|||Number
1451284|NCT00843778|Secondary|Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study|Antibody positive is defined as Anti-CZP antibody levels > 2.4 units/mL at any visit.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Safety Set|||percentage of participants|||Number
1451610|NCT00841204|Primary|Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis|||µg/g tissue||Standard Deviation|Mean
1451285|NCT00843778|Secondary|Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit|Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration. Values below the limit of quantification of 0.41 μg/mL will be set to half the limit of quantification for the summaries (0.205 μg/mL).|Week 24|Of the 130 subjects in the Safety Set, 89 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||μg/mL||95% Confidence Interval|Geometric Mean
1451286|NCT00843778|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451287|NCT00843778|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|"Change from Baseline in Fatigue Assessment Scale (0 to 10, 0 is No Fatigue and 10 is Fatigue as bad as you can imagine) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement."|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 117 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451288|NCT00843778|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS) (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 102 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Mean
1451289|NCT00843778|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 119 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||units on a scale||Standard Deviation|Median
1451290|NCT00843778|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
1451291|NCT00843778|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
1451292|NCT00843778|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20 % improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire- Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 124 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
1451311|NCT00843518|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity-Global Functioning (CGI-S-GF) at Week 12|CGI-S-GF was a 7-point, single-item rating scale for overall functioning based on the investigator’s general clinical experience with a similar participant population. This Likert scale ranged from 0 (normal) to 7 (most severely ill). LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CGI-S-GF, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451293|NCT00843778|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. <= 3.3 (Remission), >3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 120 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
1451294|NCT00843778|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. A lower CDAI score indicating improvement in activity and a higher score indicating a decline activity.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 122 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
1451295|NCT00843778|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. < 2.6 (Remission), > = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High.|Completion/Withdrawal Visit (up to approximately Week 136)|Of the 130 subjects in the Full Analysis Set, 114 subjects are included in the analysis of this outcome measure, based upon the number of subjects with an available assessment at the visit.|||percentage of participants|||Number
1451296|NCT00843778|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.|From Entry Visit up to approximately 144 weeks|Safety Set|||percentage of participants|||Number
1451297|NCT00843778|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.|From Entry Visit up to approximately 144 weeks|Safety Set|||percentage of participants|||Number
1451298|NCT00843713|Primary|Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)|Measurements in the change of brachial artery diameter from pre and post treatment.|24 weeks||||millimeters||Inter-Quartile Range|Median
1451299|NCT00843635|Secondary|Number of Participants Experiencing Adverse Events|Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events|From Day 1 to Day 20||||participants|||Number
1451300|NCT00843635|Secondary|Optimal Dosing Schedule for Tadalafil||Baseline, End of Treatment at Time of Surgery.|Optimal dosing schedule of Tadalafil not determined due to no proven superiority of one dosing arm over the other.||||||
1451301|NCT00843635|Primary|Ratio of Tumor-specific T-cell Concentration in the Blood|Ratio of the number of tumor specific T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at Time of Surgery|Data for 31 patients were analyzed.|||ratio from baseline||Inter-Quartile Range|Median
1451302|NCT00843635|Primary|Ratio of T-reg Cell Concentration in the Blood|Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..|Baseline, End of Treatment at Time of Surgery||||ratio from baseline||Inter-Quartile Range|Median
1451303|NCT00843635|Primary|Ratio of MDSC Concentration in the Blood|Ratio of the number of Myeloid Derived Suppressor Cells (MDSC) in the Blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.|Baseline, End of Treatment at time of Surgery||||ratio from baseline||Inter-Quartile Range|Median
1451304|NCT00843622|Secondary|Continuous Smoking Cessation|Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits|6-16 weeks|||||||
1451305|NCT00843622|Secondary|Point Prevalence Smoking Cessation|7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less|6, 16, 28 weeks|||||||
1451306|NCT00843622|Secondary|Biomarkers||Baseline, week 6, 16, and 28|||||||
1451307|NCT00843622|Secondary|Fagerström Test for Nicotine Dependence||Baseline, week 16 and 28|||||||
1451308|NCT00843622|Secondary|Minnesota Nicotine Withdrawal Scale||Baseline, week 6, 10, 16 and 28|||||||
1451309|NCT00843622|Primary|Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm||Week 6-28||||participants|||Number
1451310|NCT00843518|Secondary|Mean Change From Baseline in the 14-Item Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog14) at Week 12|ADAS-Cog14, a 14-item rating scale, measured the severity of cognitive dysfunction in persons with AD. Scores ranged from 0 to 90, with a higher score indicating worse cognitive functioning. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline ADAS-Cog, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451312|NCT00843518|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity-Agitation/Aggression (CGI-S-A/A) at Week 12|CGI-S-A/A was a 7-point, single-item rating scale for overall severity of symptoms based on the investigator’s general clinical experience with a similar participant population. This Likert scale ranged from 0 (normal) to 7 (most severely ill). LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CGI-S-A/A, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451313|NCT00843518|Secondary|Mean Change From Baseline in Total T-Score in the Frontal System Behaviors Scale (FrSBe) at Week 12|FrSBe was a 46-item, caregiver-rated scale that assessed behaviors associated with damage to the frontal lobes and frontal systems of the brain, including executive function, disinhibition, and apathy. Raw scores were normalized to T-scores based on gender, education, and age. Higher T scores represent a worse outcome. A score of 50 reflects a normative sample, and T scores at or above 65 are considered clinically significant. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline FrSBe, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451314|NCT00843518|Secondary|Mean Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) at Week 12|CSDD was a 19-item, clinician-rated scale designed to measure the presence and severity of depressive symptoms in dementia participants. Symptoms were rated as absent, mild/intermittent, or severe. Scores ranged from 0 to 38; scores of 8 or more suggested clinical depression. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CSDD, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451315|NCT00843518|Secondary|Mean Change From Baseline in Cohen-Mansfield Agitation Inventory-Community Version (CMAI-C) at Week 12|CMAI-C is the Cohen-Mansfield Agitation Inventory - Community Version, and it contained 36 questions. The first 35 items were rated from 1 (never) to 7 (several times per hour) and the last item asked if there was any other inappropriate behavior, with a free text field to specify the behavior. The total score ranged from 7 to 245 (7 x 35), with higher scores reflecting more severe agitation. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline CMAI-C, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451316|NCT00843518|Secondary|Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 12|The NPI Psychosis subscale score was the sum of the delusions and hallucinations items of the standard 12-item NPI that measured psychosis symptoms in participants with Alzheimer’s dementia. Scores for each subscale (frequency x severity) were calculated for each item score and ranged from 0 to 24 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI psychosis, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451317|NCT00843518|Secondary|Mean Change From Baseline in the Neuropsychiatric Inventory (NPI) Depression Domain at Week 12|NPI Depression domain was an item of the standard 12-item NPI that measured depression in participants with Alzheimer’s dementia. Scores for each subscale (frequency × severity) were calculated to obtain the item score, which ranged from 0 to 12 with higher scores indicating more frequent and/or severe neuropsychiatric symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI depression, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451318|NCT00843518|Secondary|Mean Change From Baseline in 10-Item Version of Neuropsychiatric Inventory (NPI-10) at Week 12|NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 10-item scale of the standard 12-item NPI measured neuropsychiatric symptoms minus the appetite and sleep disturbance items. Scores for each subscale (frequency × severity) were calculated to obtain the item score. The total subscale score ranged from 0 to 120, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. LS Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-10, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451319|NCT00843518|Primary|Mean Change From Baseline in the 4-Item Agitation/Aggression Subscale of the Neuropsychiatric Inventory (NPI-4 A/A) at Week 12|NPI assessed noncognitive psychopathology in participants with Alzheimer's dementia. A 4-item subscale of the standard 12-item NPI measured the neuropsychiatric symptoms of A/A, with items consisting of agitation/aggression, aberrant motor behavior, irritability/emotional lability, and disinhibition. Scores for each subscale (frequency x severity) were calculated to obtain each item score. The total subscale score ranged from 0 to 48, with higher scores indicating more frequent and/or severe A/A symptoms. If a symptom was not present at all, the site would not enter anything for frequency or severity, and a zero would be imputed for that item. Least Squares (LS) Mean value was adjusted for NPI strata, treatment, pooled site, visit, treatment-by-visit, baseline NPI-4 A/A, and baseline-by-visit interaction.|Baseline, Week 12|The analysis population included all randomized participants and was a modified intent-to-treat (ITT) population defined as having both a baseline and at least 1 post-baseline measure.|||units on a scale||Standard Error|Least Squares Mean
1451320|NCT00843492|Secondary|Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|All episodes of bleeding, except minor bruising, skin hematomas not greater than 5 centimeters in diameter, self-limited epistaxis (bleeding through the nose), and self-limited gingival (gum) bleeding, were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population|||participants|||Number
1451321|NCT00843492|Secondary|Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population|||participants|||Number
1451322|NCT00843492|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Clinically relevant non-major bleeding that does not qualify as major is defined as bleeding leading to treatment discontinuation, and/or epistaxis (bleeding through the nose) that lasts for more than 5 minutes or necessitates intervention (e.g., packing), spontaneous macroscopic haematuria (blood in urine), gastrointestinal haemorrhage, haemoptysis (coughing up blood), or subcutaneous haematoma (localized collection of blood) > 100 centimeters squared. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population|||participants|||Number
1451323|NCT00843492|Secondary|Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact|Major bleeding is defined as bleeding that results in a fatality, symptomatic bleeding in a critical area or organ, bleeding causing a fall in hemoglobin level of 20 grams/liter (1.24 millimoles/liter) or more compared with the pre-randomization hemoglobin level, or bleeding that leads to a transfusion of two or more units of whole blood or red blood cells. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment.|Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)|As-Treated Population: all participants who received at least one dose of study treatment|||participants|||Number
1451324|NCT00843492|Secondary|Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact|The number of participants with VTE (defined as asymptomatic deep vein thrombosis [DVT: the formation of a blood clot in a deep vein] detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism [PE]) and death was assessed. An embolism is a clot in the blood that forms and blocks a blood vessel. A PE is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches.|Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days)|ITT Population|||participants|||Number
1451325|NCT00843492|Secondary|Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death|All components of the primary endpoint were considered separately: any VTE; symptomatic (providing no evidence of disease existence) DVT (the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography; symptomatic(providing evidence of disease existence) DVT; symptomatic PE (blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung of one of its branches); and death.|Day 1 to complete mobilization plus 2 days (average of 35.7 study days)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
1451326|NCT00843492|Primary|Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization|VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).|Day 1 to complete mobilization plus 2 days (average of 35.9 study days)|Intent-to-Treat (ITT) Population: all randomized participants with a VTE status or experiencing death. Participants without evaluation of the primary endpoint in the timeframe requested by the protocol were considered as missing data and therefore not included in the primary efficacy analysis.|||participants|||Number
1451327|NCT00843479|Secondary|GLP-1 Area Under the Curve (AUC)|Area under the curve of glucagon-like peptide (GLP-1) concentrations (measured by ELISA kit) from time 0 to 180 min during a standard meal tolerance test, calculated by the trapezoidal rule.|1 month from screening visit||||pg/ml/min||Standard Deviation|Mean
1451328|NCT00843479|Secondary|Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration|measured in fasting serum sample by ELISA kit|within 1 month from screening visit||||pg/ml||Standard Deviation|Mean
1451329|NCT00843479|Primary|Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.|Distinctive beta-cell function as measured by the disposition index - based on the acute insulin response from the arginine stimulation test versus glucose infusion rate adjusted by free fat mass from hyperglycemic clamp - in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects.|within 1 month from screening visit||||(μmol∙kg-1.min-1)||Standard Error|Mean
1451330|NCT00843479|Primary|Adaptive Beta-cell Insulin Production. The Product of Meal Tolerance Test-derived Insulinogenic Index (IGI) for Clamp-derived Insulin Sensitivity Index (ISI) in Normoglycemic Subjects After 65 Years Old in Comparison With Middle-age Normoglycemic Subjects|Beta-cell function was determinated as the beta-cell secretion measured by meal tolerance test adjusted by insulin sensitivity assessed by the hyperglycemic clamp test:Insulinogenic Index/Insulin Sensitivity Index adjusted by free fat mass|within 1 month from screening visit||||(μmol∙kg-1min-1)||Standard Deviation|Mean
1451332|NCT00843479|Primary|Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index|Insulin sensitivity index calculated as HOMA-IR = (Glucose * Insulin) / 22.5, where glucose is mmol/L and insulin is mili-units (mU)/L. Higher values indicate lower insulin sensitivity.|within 1 month from screening visit|minimum number required to find a significant difference between groups considering the intra-subject variation|||units on a scale||Standard Deviation|Mean
1451333|NCT00843466|Primary|Investigator Global Assessment|Changes in global disease severity on a scale from 0-4 with 0 being clear and 4 being severe|Wk 4||||units on a scale||95% Confidence Interval|Mean
1451334|NCT00843349|Primary|Percentage Changes in Parathyroid Hormone (PTH) Levels|Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.|||percentage of change from baseline||Standard Deviation|Mean
1451335|NCT00843349|Primary|Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels|Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.|Week 0 - 12|All participants that completed their respective intervention periods were selected for analysis.|||percentage of change from baseline||Standard Deviation|Mean
1451336|NCT00843310|Primary|Toxicity, Time to Progression & Progression Free Survival|"Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting.~Progressive Disease: requires any one or more of the following:~Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b~Urine M-component and/or (the absolute increase must be ≥200 mg/24 h~Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dl.~Bone marrow plasma cell percentage: the absolute % must be ≥10%c~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum calcium >11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder"|every 28 days during therapy and every month after therapy for 2 years|No data are available because data were not collected. Pi left the institution and slow accrual did not allow for sufficient data collection prior to PI leaving institution. No data were analyzed.||||||
1451337|NCT00843284|Secondary|Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)|"Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.|||participants|||Number
1451338|NCT00843284|Secondary|Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)|"Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse."|Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used. Three subjects were not included in the analysis due to incomplete case report forms.|||participants|||Number
1451339|NCT00843284|Primary|Pain Related Sleep Interference|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS) was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.|||scores on a scale||Standard Deviation|Mean
1451340|NCT00843284|Primary|Daily Average Pain Scores|Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward (LOCF) method was used.|||scores on scale||Standard Deviation|Mean
1451341|NCT00843284|Secondary|Anxiety and Depression Symptoms|The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation.|Baseline, Final Visit (Week 8 or discontinuation)|Full analysis set (FAS). Full analysis set was derived from the set of all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy. Last observation carried forward method (LOCF) was used.|||participants|||Number
1451342|NCT00843193|Secondary|Number of Participants With Confirmed Positive Anti-GSK679586 Antibody Results After Initiation of Study Treatment|Serum samples were tested for presence of anti-GSK679586 antibodies. Blood samples were collected via an indwelling cannula or by direct venepuncture collected into a serum separator tube and allowed to clot for 1 to 2 hours. Samples were centrifuged and the resultant serum was transferred to 3 separate cryovials and stored at -80°C until shipped on dry ice to the central laboratory. Samples were analyzed in a tiered assay format. Number of participants with confirmed positive Anti-GSK679586 antibody results after initiation of study treatment were reported.|Up to Week 25|ITT Population.|||Participants|||Count of Participants
1451351|NCT00843193|Secondary|Number of Participants With Abnormal Vital Signs of Potential Clinical Importance: Systolic and Distolic Blood Pressure and Heart Rate.|Vital signs including systolic and diastolic blood pressure and heart rate taken at certain visits from screening to follow-up. Potential Clinical Importance Ranges were systolic blood pressure (<85 and >160millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute [BPM]). Number of participants with abnormal systolic blood pressure, diastolic blood pressure and heart rate values of potential clinical importance were summarized.|Screening, Day -28, 1, 15, 29, 50, 57 and 169 (follow-up 3)|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1451343|NCT00843193|Secondary|PK Parameter: Volume of Distribution|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, volume of distribution were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The volume of distribution at Day 1 indicates volume of distribution(0-1 h), Day 29 indicated volume of distribution (0-672 h) and Day 57 indicated volume of distribution (0-1344 h). Volume of distribution for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V). The 2-compartment model provided the data for volume of distribution of central compartment (V1) and volume distribution of peripheral compartment (V2).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||L/Kg||Geometric Coefficient of Variation|Geometric Mean
1451344|NCT00843193|Secondary|PK Parameter: Systemic Clearance of Parent Drug|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, systemic clearance were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The systemic clearance at Day 1 indicates systemic clearance(0-1 h), Day 29 indicated systemic clearance(0-672 h) and Day 57 indicated systemic clearance(0-1344 h). Systemic clearance of parent drug for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||L/h/kg||Geometric Coefficient of Variation|Geometric Mean
1451345|NCT00843193|Secondary|PK Parameter:Maximum Observed Concentration (Cmax)|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, Cmax were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The Cmax at Day 1 indicates Cmax(0-1 h), Day 29 indicated Cmax(0-672 h) and Day 57 indicated Cmax(0-1344 h). Cmax for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population. Only those participants with data available at the indicated time points were analyzed.|||nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
1451346|NCT00843193|Secondary|Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over the Dosing Interval (AUC (0-τ)).|Plasma concentration-time data were well described by a 2-compartment model with first order elimination. Plasma concentrations of GSK679586 were determined at Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits. However, the derived PK parameters were determined only for the day of infusion administration. i.e. Day 1, Day 29 and Day 57. The AUC at Day 1 indicates AUC(0-1 h), Day 29 indicated AUC(0-672 h) and Day 57 indicated AUC(0-1344h). AUC(0-τ) for each participant was reconstructed from sparse PK sampling using Bayesian prediction obtained from a population PK model using nonlinear mixed effects methods (NONMEM, version V).|Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.|PK Population comprised of participants in the ITT population for whom a pharmacokinetic samples were obtained and analyzed. Only those participants with data available at the indicated time points were analyzed.|||nanogram*hour/mL||Geometric Coefficient of Variation|Geometric Mean
1451347|NCT00843193|Secondary|Number of Participants With Abnormal Urinanalysis Parameters of Potential Clinical Importance|Samples were collected on each visit from Week 1 to Week 25 for urinalysis. Number of participants with any abnormal urinalysis parameters of potential clinical importance are summarized here.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1451348|NCT00843193|Secondary|Number of Participants With Abnormal Clinical Chemistry Parameters of Potential Clinical Importance|Blood samples were collected on each visit from Week 1 to Week 25 to assess the clinical chemistry parameters. Albumin, Calcium, Glucose, Pottasium, Sodium and Total Carbon Di-oxide were analyzed in clinical chemistry. Number of participants with any abnormal clinical chemistry parameters of potential clinical importance are summarized here.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1451349|NCT00843193|Secondary|Number of Participants With Abnormal Hematological Parameters of Potential Clinical Importance|Blood samples were collected on each visit from Week 1 to Week 25 to assess the haematological parameters. White Blood Cells count, Neutrophils, Haemoglobin, Hematocrit, Count and Lymphocytes were analyzed in haematology. Number of participants with any abnormal hematological parameters of potential clinical importance are summarized here.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1451350|NCT00843193|Secondary|Number of Participants With Clinically Significant Abnormality in 12-lead Electrocardiogram (ECG)|Single 12-lead ECGs were obtained at certain visits from screening to follow-up. ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and Corrected QT (QTc) intervals. Number of participants with clinically significant abnormality in 12-lead ECG readings were summarized.|Upto Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1451611|NCT00841204|Primary|Sulindac Concentration in the Nevi (Moles)||8 weeks|All randomized participants were included in the analysis except one participant in the sulindac arm did not provide nevi sample for analysis|||µg/g tissue||Standard Deviation|Mean
1451352|NCT00843193|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|Up to Week 25|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1451353|NCT00843193|Secondary|Percentage of Participants Who Demonstrated a Clinically Meaningful Increase in FEV1 Over the 12 Week Assessment Period|FEV1 is forced expiratory volume in 1 second.A participant is defined as a FEV1 responder if he/she achieves a change from baseline FEV1 of >=200ml. To evaluate whether the participant was a responder over 12 weeks, change from baseline FEV1 over 12 weeks was calculated by taking the mean of the changes at Visit 7, Visit 9 and Visit 11. A binary variable was created for each participant with 1 for the responder and 0 for the non-responder. If either Visit 9 or Visit 11 FEV1 data are missing, then the binary variable for the responder over 12 weeks was set to be missing. If Visit 7 data were missing, but Visit 9 and Visit 11 data were available, then the binary variable for the responder over 12 weeks was still calculated.|Upto 12 weeks|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percentage of Participants|||Number
1451354|NCT00843193|Secondary|Change From Baseline in FEV1 Over 16 Weeks and 24 Weeks|FEV1 is forced expiratory volume in 1 second.Change from Baseline FEV1 was calculated for each of the following visit: Visit 6, Visit 7, Visit 9 and Visit 11. A binary variable was created for each participant with 1 for the responder and 0 for the non nonresponder at each visit. Week 1 was considered as the Baseline. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well. Change from Baseline of Week 16 and Week 24 are incorporated here which are Follow up weeks.|Week 16 and 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||mL||Standard Error|Mean
1451355|NCT00843193|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) Over 12 Weeks.|FEV1 is forced expiratory volume in 1 second.Change from Baseline FEV1 was calculated for each of the following visit: Visit 6, Visit 7, Visit 9 and Visit 11. A binary variable was created for each participant with 1 for the responder and 0 for the non nonresponder at each visit. Week 1 was considered as the Baseline. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline to Week 12|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Millilitre (mL)||Standard Error|Mean
1451356|NCT00843193|Secondary|Number of Participants Who Demonstrated a Clinically Meaningful Change in ACQ-7 Over the 12 Weeks Assessment Period.|The ACQ-7 is a 7-item questionnaire that provides a measure of a participant’s asthma control. Participant responses were recorded on a 7-point scale ranging from zero (no impairment/ limitation) to 6 (total impairment/ limitation). The percentage of participants who were classified as responders for ACQ-7, defined as a clinically meaningful decrease from baseline in ACQ-7 of at least 0.50, was generally similar between treatment groups at each visit and over the 12-week treatment period.|Upto 12 weeks|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1451357|NCT00843193|Secondary|Change From Baseline in ACQ-7 Over 16 Weeks and 24 Weeks|The ACQ-7 is a 7-item questionnaire that provides a measure of a participant’s asthma control. Participant responses were recorded on a 7-point scale ranging from zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well. Change from Baseline of Week 16 and Week 24 are incorporated here which are Follow up weeks.|Week 16 and Week 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Error|Mean
1451358|NCT00843193|Primary|Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks|The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. ACQ-7 was calculated as the average of the 7 scores. If any one individual score was missing, the ACQ-7 was set to missing.The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline to Week 12|Intent-to-Treat (ITT) population was comprised of all participants who are randomized and receive at least the first dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Scores on Scale||Standard Error|Mean
1451359|NCT00843180|Secondary|Days to Recovery Neutrophil Count|number of days to recovery neutrophil count >500 cells per microliter for 2 consecutive days (range, up to 100 days, censored at 100 days)|hospital stay||||number of days||95% Confidence Interval|Mean
1451360|NCT00843180|Secondary|Days of Hospital Stay|days of hospital stay after bone marrow transplant (up to 100 days; participant observation was censored after 100 days)|days of hospital stay after bone marrow transplant|ITT|||number of days||95% Confidence Interval|Mean
1451361|NCT00843180|Secondary|Number of Vomiting Episodes|number of vomiting episodes as reported by nurses per occurence (no upper limit)|day -7 to +21 around transplant date|ITT|||number of episodes||95% Confidence Interval|Mean
1451362|NCT00843180|Primary|Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)|days of pain >3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)|7 days pre to 21 days post transplant = 28 days|ITT no imputations|||days||95% Confidence Interval|Mean
1451363|NCT00843167|Secondary|Treatment Compliance|For treatment compliance, participants who take >=80% of the prescribed pills will be considered to be treatment-compliant.|Baseline and end of study (up to 8 weeks)||||participants|||Number
1452285|NCT00835185|Secondary|t1/2 at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour post dose|Zero participants were analyzed, t1/2 results were not collected.||||||
1451364|NCT00843167|Primary|Change in Histone Deacetylase (HDAC) Activity as Assessed in Peripheral Blood Mononuclear Cells (PBMC) at Baseline and After Completion of Study Therapy|PBMC HDAC activity was evaluated using the positive control, sodium butyrate.HDAC activity is expressed relative to PBMC protein content and negative control.|Baseline and End of Study (up to 8 weeks)|PBMCs available pre-/post-intervention.|||pmol/min/mg protein||Standard Error|Mean
1451365|NCT00843167|Primary|Change in Ki-67 as Assessed at Baseline and After Completion of Study Therapy|Ki-67 was measured through immunohistochemistry method. A modified H-score was recorded, which involved semi-quantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate staining, and 3 strong staining) and percentage of positive cells. The range of the H-score was 0-300. The maximum score indicates the strongest expression, the minimum score indicates no expression of positive tumor area.|Baseline and end of study (up to 8 weeks)|Maximum two observations (pre- and post- treatments) were expected per participant. Linear mixed effect models were used to calculate adjusted least square means (LSMEANS) and 95% confidence intervals,& to test the statistical significance of the difference between pre- and post- treatments within each group, as well as between treatment groups.|||Log 2 (H-score)||95% Confidence Interval|Least Squares Mean
1451366|NCT00843167|Primary|Change in Isothiocyanate in Urine Samples as Assessed at Baseline and After Completion of Study Therapy|Isothiocyante including sulforaphane in micromolar (µM) concentration was measured following standard chemical measurement procedures and divided by the creatinine values in millimolar (mM) concentration.|Baseline and end of study (up to 8 weeks)||||µM/mM creatinine||Standard Error|Mean
1451367|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF"|baseline, Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451368|NCT00843115|Secondary|Change From Baseline in Subject's Anxiety/Depression at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451369|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451370|NCT00843115|Secondary|Change From Baseline in Subject's Pain/Discomfort at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451371|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF"|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451372|NCT00843115|Secondary|Change From Baseline in Subject's Usual Activities at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12."|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451373|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and “no problem” at baseline versus at Week 12 LOCF."|baseline, 12 Weeks LOCF|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451374|NCT00843115|Secondary|Change From Baseline in Subject's Self-Care at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12"|baseline, Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451375|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12 LOCF|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF"|Week 12 LOCF|Intent to Treat (ITT) LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451438|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Is This Medication Easy to Take?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Is this medication easy to take?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451376|NCT00843115|Secondary|Change From Baseline in Subject's Mobility at Week 12|"EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12."|baseline, 12 Weeks|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451377|NCT00843115|Secondary|LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks LOCF|Intent to Treat (ITT)LOCF: (n=318; number of subjects responding).|||score on scale||Standard Deviation|Mean
1451378|NCT00843115|Secondary|Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire|EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT): (n=286; number of subjects responding).|||score on scale||Standard Deviation|Mean
1451379|NCT00843115|Secondary|LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=321; number of subjects responding)|||score on scale||Standard Deviation|Mean
1451380|NCT00843115|Secondary|Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)|EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score|baseline, 12 Weeks|Intent to Treat (ITT) (n=290; number of subjects responding)|||score on scale||Standard Deviation|Mean
1451381|NCT00843115|Secondary|Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.|baseline, 12 Weeks LOCF|Intent to Treat (ITT) LOCF: (n=231; number of patients responding)|||Pearson Product Correlation Coefficient|||Number
1451382|NCT00843115|Secondary|Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)|QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.|baseline, 12 Weeks|Intent to Treat (ITT). (n=207 number of subjects responding)|||Pearson Product Correlation Coefficient|||Number
1451383|NCT00843115|Secondary|LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Week LOCF|Intent to Treat (ITT)LOCF: (n=231; number of subjects responding)|||score on scale||Standard Deviation|Mean
1451384|NCT00843115|Secondary|Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores|Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.|baseline, 12 Weeks|Intent to Treat (ITT). (n= 207; number of subjects who responded)|||score on scale||Standard Deviation|Mean
1451385|NCT00843115|Secondary|Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=231; number of subjects responding).|||Pearson Product Correlation Coefficient|||Number
1451386|NCT00843115|Secondary|Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score|MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.|baseline, 12 Weeks|Intent to Treat (ITT); n=207 (number of subjects who responded)|||Pearson Product Correlation Coefficient|||Number
1451387|NCT00843115|Secondary|Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline|baseline, Week 12 LOCF|Intent to Treat (ITT) LOCF: (n=318; number of subjects responding)|||score on scale||Standard Deviation|Mean
1451388|NCT00843115|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.|baseline, Week 12|Intent to Treat (ITT): (n=288; number of subjects responding)|||score on scale||Standard Deviation|Mean
1451389|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451390|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451391|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451392|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451393|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451394|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451395|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451396|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451397|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451398|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451399|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451400|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451401|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451402|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451403|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451404|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451405|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451406|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||participants|||Number
1451407|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis|||Participants|||Number
1451408|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT) : All subjects who did not have a response for post baseline assessment were not included in analysis.|||Participants|||Number
1451409|NCT00843115|Primary|All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment|Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.|Baseline and Week 12|Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis.|||participants|||Number
1451410|NCT00843050|Secondary|Time to Progression|It is defined as the time from day 1 of the study drug administration until the first date of progressive disease.|End of study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.|||years||Standard Deviation|Mean
1451411|NCT00843050|Secondary|Duration of Response|It is defined as the time from when the measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively or clinically documented.|End of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.|||proportion of participants||Inter-Quartile Range|Median
1451612|NCT00841087|Secondary|Systolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
1451412|NCT00843050|Primary|Best Overall Objective Response Rate|The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.|End of every 2 cycles and end of the study treatment|The efficacy population includes all patients who have completed at least two cycles of P276-00 therapy and have tumor measurements.|||proportion of participants||Standard Deviation|Mean
1451413|NCT00843024|Other Pre-specified|Mean Body Mass Index of Participants at Baseline Categorized by Age Group|The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).|Baseline|ITT Population|||Kilograms per meters squared (kg/m^2)||Standard Deviation|Mean
1451414|NCT00843024|Other Pre-specified|Mean Weight of Participants at Baseline Categorized by Age Group|The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Kilograms (kg)||Standard Deviation|Mean
1451415|NCT00843024|Other Pre-specified|Number of Participants of the Indicated Race Categorized by Age Group|The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Participants|||Number
1451416|NCT00843024|Other Pre-specified|Number of Female and Male Participants Categorized by Age Group|The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Participants|||Number
1451417|NCT00843024|Other Pre-specified|Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline|The number of participants receiving double-blind treatment were reported according to age.|Baseline|ITT Population|||Participants|||Number
1451418|NCT00843024|Other Pre-specified|Mean Age of Participants at Baseline Categorized by Age Group|The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.|Baseline|ITT Population|||Years||Standard Deviation|Mean
1451419|NCT00843024|Secondary|Number of Participants Nausea-free at 2 Hours Post-dose|The number of participants who did not have nausea at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451420|NCT00843024|Secondary|Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.|Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451421|NCT00843024|Secondary|Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose|Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451422|NCT00843024|Secondary|Number of Participants Sustained Nausea-free From 2-24 Hours|Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451423|NCT00843024|Secondary|Number of Participants Sustained Phonophobia-free From 2-24 Hours|Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451424|NCT00843024|Secondary|Number of Participants Sustained Photophobia-free From 2-24 Hours|Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451425|NCT00843024|Secondary|Number of Participants Pain-free at 1 Hour Post-dose|Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.|1 hour after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451426|NCT00843024|Secondary|Number of Participants Phonophobia-free at 2 Hours Post-dose|The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451427|NCT00843024|Secondary|Number of Participants Photophobia-free at 2 Hours Post-dose|The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451428|NCT00843024|Secondary|Number of Participants Sustained Pain-free From 2-24 Hours|Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.|2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population. Participants were not included in pain-related analyses if their baseline pain was not moderate or severe, and were not included in analyses of pain or symptoms if they had no post-baseline evaluation of the relevant pain or symptom up to the time point analyzed.|||participants|||Number
1451429|NCT00843024|Primary|Number of Participants Who Were Pain Free at 2 Hours Post-dose|Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.|2 hours after single dose of double-blind treatment (Randomization through Week 13)|ITT Population: participants who took a dose of double-blind randomized treatment and provided some assessment of their migraine pain or associated symptoms. Participants were not included in this analysis if their baseline pain was not moderate or severe, or if they had no post-baseline evaluation of pain up to the time point analyzed.|||participants|||Number
1451430|NCT00842985|Primary|CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing|"CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component.~This study used two subscales of the RVIP.~RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good.~RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present.~The range is from -1 to +1 ; bad to good~The numbers represent probabilities as units on a scale."|Once for each test session (4 total).|Subjects who completed all four treatment sessions. Three of these 15 subjects were not analyzed due to validity concerns of the cognitive data for at least one of the four testing sessions.|||units on a scale||Standard Deviation|Mean
1451431|NCT00842946|Primary|Number of Participants in Remission (Per Structured Clinical Interview for DSM-IV Axis I Disorders (SCID))|"The SCID (First, Spitzer, Gibbon, & Williams, 1996) is an extensively utilized structured diagnostic interview based on DSM-IV criteria. Estimates of interrater reliability range from moderate to high for most Axis I disorders (e.g., Williams et al., 1992; Zanarini~& Frankenburg, 2001)."|6-weeks post-treatment||||participants|||Number
1451432|NCT00842829|Secondary|Participants With Adverse Events (AE) Summarized by Treatment Period|Participants with treatment-emergent adverse events are summarized by each treatment period. Relation to study drug was assessed by the investigator. The 'Any AE' category below includes serious adverse events.|Day 1-7 (Titration Period). Day 8-15 (Treatment Period), Days 16-688 (Continuation Period)|Safety analysis set|||participants|||Number
1451433|NCT00842829|Secondary|Participant's Global Impression of Change at the End of the Treatment Period|Global impression of change was assessed using the question 'Since the start of the study, my overall status is?'. The answer was based on a 7-point scale (1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451434|NCT00842829|Secondary|Participant's Global Assessment of Ease of Use at the End of the Treatment Period|Ease of use was assessed using the question ‘Did you find this treatment easy/convenient to use for treatment of your breakthrough pain episodes?’. The answer was based on a 4-point numerical scale (0=Poor, 1=Fair, 2=Easy, 3=Very Easy). This assessment was performed at the end of the Treatment Period (or early termination).|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451435|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Understand the Instructions?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you understand the instructions?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451436|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Feel Safe Taking This Medication?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you feel safe taking this medication?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451437|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Do You Find This Medication Comfortable to Take in Public?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Do you find this medication comfortable to take in public?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451613|NCT00841087|Secondary|Diastolic Blood Pressure (BP)|Mean values at baseline (Week 0) and at Week 6|Week 0, Week 6|Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator.|||mmHg||Standard Deviation|Mean
1451439|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Provide Adequate Relief?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication provide adequate relief?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451440|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This Medication Work Fast?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this medication work fast?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451441|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Does This BTP Medication Relieve Your Pain Quickly so You Can Get Back to Sleep?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Does this BTP medication relieve your pain quickly so you can get back to sleep?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451442|NCT00842829|Secondary|Participant's Global Assessment of Satisfaction (Satisfied With BTP Treatment?) at the End of the Treatment Period|"Responses to the Patient Satisfaction questionnaire question, Satisfied with the BTP Treatment?, were captured on a five-point scale from 0=not at all to 4=very much."|approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with a response|||participants|||Number
1451443|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire: Global Score|Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. The Global Score is the sum of the subscales (total scale is 0-70). A negative change from baseline represents an improvement.|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451444|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Enjoyment of Life|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses enjoyment of life."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451445|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Sleep|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses sleep."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451446|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Relations With Other People|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses relations with other people."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451447|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Normal Work|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses normal work."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451448|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Walking Ability|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses walking ability."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451449|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: Mood|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses mood."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451461|NCT00842712|Secondary|Randomized Part: Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1451450|NCT00842829|Secondary|Change From Baseline to End of Treatment Period (Approximately Day 15) in the Brief Pain Inventory 7-item (BPI-7S) Questionnaire Subscale: General Activity|"Participants completed the BPI-7S questionnaire to indicate their quality of life and functional status between study time points. For each subscale, the participant rated their responses from 0=Does not interfere through to 10=Completely interferes. A negative change from baseline represents an improvement.~This subscale assesses general activity."|Day 0 (baseline), approximately Day 15 (end of Treatment Period)|Safety analysis set of participants with both baseline and Treatment Period responses|||units on a scale||Standard Deviation|Mean
1451451|NCT00842829|Secondary|Participant Assessment of Medication Performance During the Treatment Period|Participants assessed the performance of FBT at 30 minutes and 60 minutes after dosing each episode during the treatment period. For each episode, the participant answered the question ‘How well did your study medication perform in controlling the breakthrough pain episode?’ on a 5-point Likert-type scale (poor=0, fair=1, good=2, very good=3, and excellent=4).|approximately Day 8-15|Safety analysis set of participants with a response at the time point (30 or 60 minutes) post dose.|||BTP episodes|Participants||Number
1451452|NCT00842829|Secondary|Breakthrough Pain (BTP) Episodes Requiring the Use of Rescue Medication During the Titration Period and the Treatment Period|The number of breakthrough pain (BTP) episodes in which the participant did not obtain effective pain relief from study medication and took a rescue medication.|Days 1 to up to Day 7 (Titration Period); approximately Day 8 up to Day 15 (Treatment Period)|Safety analysis set consisting of participants who took at least one dose of study drug during the relevant study period.|||BTP episodes|Participants||Number
1451453|NCT00842829|Secondary|Number of Participants Reaching An Effective Dose As Assessed by the Participant During the Titration Period|Number of participants for which an effective dose of FBT was reached as judged by each participant. The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.|||participants|||Number
1451454|NCT00842829|Secondary|Kaplan-Meier Estimates for Time to Meaningful Pain Relief As Assessed by Participants During the Treatment Period For Overall Breakthrough Pain (BTP) Episodes|Overall episode data analyzed all values of time to meaningful pain relief taken over all BTP episodes during the treatment period. If meaningful pain relief was not achieved within 60 minutes of FBT intake, or if rescue medication was taken, the event was censored. Meaningful pain relief was left to the judgment of participants, who used a stopwatch and recorded the time from treatment until pain relief in a patient diary.|approximately Day 8-15|Safety analysis set consisting of participants who received at least one dose of study drug during the Treatment Period, and who recorded the time to pain relief in the patient diary.|||minutes|Participants|Inter-Quartile Range|Median
1451455|NCT00842829|Primary|Percentage of Participants Reaching an Effective Fentanyl Buccal Tablet (FBT) Dose As Assessed by the Participant During the Titration Period|The effective dose was the dose that, for 2 consecutive break-through pain (BTP) episodes, provided adequate analgesia within the first 30 minutes after administration of study drug and that minimized undesirable effects. The assessment was performed by the participant and was reported in the titration-period diary. The next BTP episode was used to confirm the effective dose, and if confirmed, the effective dose was used for all following BTP episodes.|Day 1 up to Day 7|Titration safety analysis set consisting of participants who took at least one dose of study medication.|||percentage of treated participants|||Number
1451456|NCT00842751|Primary|Serum Estradiol Concentration|Area under the curve of serum estradiol|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.|||ng*hr/dL||Inter-Quartile Range|Geometric Mean
1451457|NCT00842751|Primary|Serum Dihydrotestosterone Concentration|Area under the curve of serum dihydrotestosterone|0,1,2,4,8,and 12-hour post dose|All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.|||ng*hr/dL||Inter-Quartile Range|Geometric Mean
1451458|NCT00842751|Primary|Maximum Testosterone Concentration|Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.|0,1,2,4,8,and 12-hour post dose|All participant received all treatments and is, therefore, included in the analysis population for all groups.|||ng*hr/dL||Inter-Quartile Range|Geometric Mean
1451459|NCT00842712|Secondary|Randomized Part: Time to Treatment Failure|Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC).|Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1451460|NCT00842712|Secondary|Randomized Part: Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
1452286|NCT00835185|Secondary|Area Under the Curve (AUC) at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, AUC results were not collected.||||||
1451462|NCT00842712|Secondary|Randomized Part: Progression Free Survival (PFS) Time - Investigator Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1451463|NCT00842712|Primary|Randomized Part: Progression Free Survival (PFS) Time - Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)|Intent-to-treat (ITT) population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1451464|NCT00842712|Primary|Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)||Up to Week 3|DLT population included all participants who completed first 3 weeks of treatment (first chemotherapy cycle) or who discontinued treatment due to any DLT during the first 3 weeks of treatment in the safety-run-in part.|||participants|||Number
1451465|NCT00842608|Secondary|Mortality||ICU, in-hospital, 30-days post hospitalization||||Participants|||Count of Participants
1451466|NCT00842608|Secondary|Hospital Length of Stay Post Randomization||Participants were followed for the duration of hospital stay, an average of 11 days||||days||Standard Deviation|Mean
1451467|NCT00842608|Primary|Days Free of Delirium and Coma||Admission through day 8 of stay||||days||Inter-Quartile Range|Median
1451468|NCT00842543|Primary|Percent Change From Baseline in Beta-Carotene in Overweight and Lean Boys|Value at 6 months minus value at baseline. Beta-carotene is a component of the body’s natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline and 6 months||||Percent Change||Standard Error|Least Squares Mean
1451469|NCT00842543|Primary|Beta-carotene Levels Between Overweight and Lean Boys at Baseline|Value at baseline. Beta-carotene is a component of the body’s natural defense system against every day oxidative stress. Beta-carotene concentrations were measured by reverse-phase high-performance liquid chromatography with photodiode array detection between 220-600 nm.|Baseline||||mM/L||Inter-Quartile Range|Median
1451470|NCT00842361|Secondary|Systolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6.|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
1451471|NCT00842361|Secondary|Diastolic BP (Blood Pressure)|Values at baseline (Week 0) and at Week 6|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
1451472|NCT00842361|Secondary|Electrocardiogram (ECG) Worsening|The number of subjects having an electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||participants|||Number
1451473|NCT00842361|Secondary|Change in Body Weight|Change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
1451474|NCT00842361|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1451475|NCT00842361|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
1451476|NCT00842361|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
1451490|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|12 months|Only 280 subjects (350 limbs) completed the 12 Month follow-up visit to provide data to this outcome measure.|||limbs|limbs||Count of Units
1451491|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|3 months|Only 302 subjects (371 limbs) completed the 3 Month follow-up visit to provide data to this outcome measure.|||limbs|limbs||Count of Units
1451477|NCT00842348|Secondary|Progression Free Survival (PFS): Kaplan-Meier Estimate|"The time from randomisation in Study 726 to the first occurrence of either disease progression (measured using Response Evaluation Criteria In Solid Tumours [RECIST] criteria) or death in Study 726 or in Study 729, or equivalently, the Progression Free Survival (PFS) time.~Tumour assessments for the placebo group after switching to open label lanreotide Autogel were excluded for the purpose of this analysis. Estimation of the median was based on the Kaplan-Meier method."|Throughout the study (every 24 weeks and at completion/withdrawal visit)|Intention-to-treat (ITT) population: all patients randomised in the original protocol Study 726 (regardless of whether they continued into the extension Study 729). The ITT population was analysed using patients as randomised in Study 726.|||weeks||95% Confidence Interval|Median
1451478|NCT00842348|Primary|Adverse Events|"Adverse events (AEs) that were ongoing from Study 726 at the time of entry into Study 729 were transcribed into the case report form (CRF) for Study 729 with a start date corresponding to the original report of this AE in Study 726. All new AEs that started after the last visit in Study 726 (i.e. irrespective of whether the AE had onset before or after giving informed consent for Study 729) were recorded Study 729.~An AE was considered as a treatment emergent adverse event (TEAE) for Study 729 if:~It was not present prior to receiving the first dose of study treatment in Study 729; or,~It was present prior to receiving the first dose of study treatment in Study 729 but the intensity increased after the first dose of study treatment in Study 729.~Adverse event data are presented in the AE section."|Throughout the study until the completion/early discontinuation visit.|Safety population: all patients who received at least one dose of lanreotide Autogel in Study 729.|||participants with any TEAEs|||Number
1451479|NCT00842335|Secondary|Days to Progression|Progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions|Up to 112 days (four 28-day cycles) or longer if the patient is benefiting from treatment|The efficacy analyses were performed using all patients, who had at least one post-treatment evaluation for tumor assessment (N=17). The overall response was based on the number of cycles of treatment before the participant experienced progressive disease.|||days||Full Range|Median
1451480|NCT00842335|Secondary|Overall Clinical Response by Cycle|"Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.~Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions"|Up to 112 days ( four 28-day cycles)|All 18 participants were analyzed.|||participants|||Number
1451481|NCT00842335|Secondary|Number of Participants Reaching Maximum Tolerated Dose|Number of participants withdrawn from study due to adverse events|Up to 112 days (up to four 28-day cycles) or longer if the patient is benefiting from treatment|Only one subject withdrew due to an adverse event.|||participants|||Number
1451482|NCT00842335|Primary|Maximum Tolerated Dose (MTD) of JI-101|"The primary objective of this study was to determine the maximum tolerated dose (MTD) of JI-101 when administered orally in patients with advanced solid tumors.~The MTD was established based on safety data from Cycle 1. Patients who completed 21 days of treatment in Cycle 1 were considered to have completed the study for the determination of MTD.~Patients were eligible to continue treatment with JI-101 until they experienced disease progression or unacceptable treatment-related toxicity. Unacceptable treatment-related toxicity was defined as a clinically significant AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and that was attributed to JI 101."|28 days (1 cycle)|"Full Analysis Population (FAS) or Modified Intent-to-Treat (mITT) Population: All patients enrolled into the study who received JI-101 and completed at least 21 days of dosing in Cycle 1 comprised the FAS.~Safety Population: Included all patients who received at least one dose of study drug. This population was used for all safety analyses."|||mg|||Number
1451483|NCT00842296|Secondary|Presence of Complications From GSV Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|5 years||||limbs|limbs||Count of Units
1451484|NCT00842296|Secondary|Presence of Complications From GSV Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|12 months||||limbs|limbs||Count of Units
1451485|NCT00842296|Secondary|Presence of Complications From GSV Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|3 Months||||limbs|limbs||Count of Units
1451486|NCT00842296|Secondary|Presence of Complications From Greater Saphenous Vein (GSV) Intervention|Number of limbs that presented with the listed complications and side effects resulting from the GSV intervention.|1 Week||||limbs|limbs||Count of Units
1451487|NCT00842296|Secondary|Visual Analog Pain Scale (VAS)|Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VAS for pain scored from 0-10 with 10 being worst possible pain|5 years||||units on a scale (0-10)|limbs|Standard Deviation|Mean
1451488|NCT00842296|Secondary|Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up|"Status of clinical signs and symptoms of lower limb venous disease evaluated using standardized scales and subject responses to post-procedure standardized questions - VCSS Status from Baseline to 5 years. VCSS assesses 10 factors of venous disease whereby each factor is graded on a severity scale of 0-3 (least to worst). The higher the VCSS score the most severe the clinical signs and symptoms of venous disease are in a patient. VCSS improvement over time is presented by a decrease in VCSS total score (maximum score = 30; minimum score = 0).~Reference: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg 2000;31:1307-12."|Baseline thru 5 years||||VCSS Score|limbs|Standard Deviation|Mean
1451489|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|5 years|Only 221 subjects (279 limbs) completed the 5 Year follow-up visit to provide data to this outcome measure.|||limbs|limbs||Count of Units
1451492|NCT00842296|Secondary|CEAP Classification|Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at follow-up where C1 is the best and C6 is the worst in terms of clinical status.|1 Week||||limbs|limbs||Count of Units
1451493|NCT00842296|Secondary|CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification|"Status of clinical signs and symptoms of lower limb venous disease as measured by CEAP Classification at baseline. The CEAP clinical Categories are as follows where C1 is of the least clinical concern and C6 is the worst stage; C1- Reticular and spider veins C2- Varicose veins C3- Varicose veins and leg swelling C4- Varicose veins and evidence of venous stasis skin changes C5- Varicose veins and a healed venous stasis ulceration C6- Varicose veins and an open venous ulceration~Reference: Kistner RL, Eklof B, Masuda EM. Diagnosis of chronic venous disease of the lower extremities: The “CEAP” classification. Mayo Clinic Proc 1996;71:338-45."|Baseline||||limbs|limbs||Count of Units
1451494|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|5 years|279 limbs were evaluated at the 5Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451495|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|4 years|275 limbs were evaluated at the 4Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451496|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|3 years|293 limbs were evaluated at the 3Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451497|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|2 years|329 limbs were evaluated at the 2Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451498|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|12 months|350 limbs were evaluated at the 12M timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451499|NCT00842296|Primary|Percentage of Limbs Without Reflux in the Treated Vein Segment|No reflux in the vein segment treated. Reflux was defined as reversal flow >0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.|6 months|363 limbs were evaluated at the 6M timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451500|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|5 years|279 limbs were evaluated at the 5Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451501|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|4 years|275 limbs were evaluated at the 4Y timepoint|||Percentage of limbs|limbs|Standard Error|Mean
1451502|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|3 years|293 limbs were evaluated at the 3Y timepoint|||percentage of limbs|limbs|Standard Error|Mean
1451503|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Vein occlusion is defined as the absence of flow in the treated vein as documented on the post-procedure and each successive follow-up DU scan.|2 years|Out of the limbs treated 329 limbs were available for a Duplex Ultrasound scan at the 2Y follow-up|||percentage of limbs|limbs|Standard Error|Mean
1451504|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures < 3 cm in length, does not constitute a failure.|12 months|350 limbs were evaluated at the 12M timepoint|||percentage of limbs|limbs|Standard Error|Mean
1451505|NCT00842296|Primary|Percentage of Limbs Without Vein Occlusion|Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up Duplex Ultrasound (DU) scan. Flow which originates in the Saphenofemoral Junction (SFJ) and which measures < 3 cm in length, does not constitute a failure.|6 Months|363 limbs were available for primary outcome measure evaluation at the 6M timepoint.|||percentage of limbs|limbs|Standard Error|Mean
1451506|NCT00842257|Secondary|Disease Control Rate as Defined by RECIST Criteria|Disease Control Rate as defined by RECIST criteria. The number patients achieving stable disease, partial response, or complete response at some point during follow-up.|3 years|One patient withdrawn for an infusion reaction prior to first re-staging CT scans.|||Participants|||Count of Participants
1451507|NCT00842257|Secondary|Median Overall Survival|The duration of time from start of treatment to time of death or otherwise the date of last tumor assessment. Median survival was calculated using Kaplan Meier suvival analysis.|3 years||||Months||Full Range|Median
1451508|NCT00842257|Secondary|Median Progression Free Survival (PFS)|The duration of time from start of treatment to time of radiologic disease progression per RECIST or death, or otherwise the date of last tumor assessment. Median PFS was calculated using Kaplan Meier suvival analysis. Progressive disease is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|3 years|One patient withdrawn due to an infusion reaction prior to first re-staging CT scans.|||Months||Full Range|Median
1451540|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
1451509|NCT00842257|Primary|Response Rate of Single Agent Panitumumab Among Patients With KRAS Wild-type Colorectal Cancer Previously Treated With Cetuximab.|"The response rate of single agent panitumumab among patients with KRAS wild-type (Kirsten rat sarcoma viral oncogene homolog) colorectal cancer previously treated with cetuximab. Inclusive of three patients with clinical progression prior to first re-staging CT scans. Response rate evaluated using RECIST (Response Evaluation Criteria In Solid Tumors). Best overall response is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).~RECIST:~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD (longest diameter) of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions"|3 years|One patient withdrawn for an infusion reaction prior to first re-staging CT scans.|||Participants|||Count of Participants
1451510|NCT00842244|Secondary|Progression-Free Survival (PFS)|"Time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was a>=20% increase in sum of the longest dimensions of target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions."|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.|||months||95% Confidence Interval|Median
1451511|NCT00842244|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response. CR = disappearance of all target lesions. PR = at least 30% decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Analysis set included a subset of efficacy analysis set who had confirmed objective tumor response.|||months||95% Confidence Interval|Median
1451512|NCT00842244|Secondary|Percentage of Participants With Objective Response (OR)|Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent (%) decrease in sum of the longest dimensions of target lesions taking the baseline sum of the longest dimensions as a reference.|Baseline up to disease progression or withdrawal, assessed on Day 21 of every other cycle starting from Cycle 2 up to Day 784|Efficacy analysis set included all enrolled participants who received at least 1 dose of study medication, had measurable disease at baseline (according to RECIST criteria version 1.0), and had at least 1 tumor assessment during study.|||percentage of participants||95% Confidence Interval|Number
1451513|NCT00842244|Secondary|Drug Metabolizing Enzyme Genotyping|Genetic variants of uridine diphosphate (UDP)- glucuronosyl transferase 1A1 (UGT1A1) gene which were assessed for genotyping included UGT1A1*60, UGT1A1-3156, UGT1A1 Promoter thymine adenine (TA) repeat (UGT1A1*28, UGT1A1*36, UGT1A1*37), UGT1A1*6 and UGT1A1*27.|Day 1 of Cycle 1|Results are not reported because data was reported in individual participant listing but not statistically summarized for the analysis.||||||
1451514|NCT00842244|Secondary|Volume of Distribution (Vz) for Cisplatin|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter||95% Confidence Interval|Geometric Mean
1451515|NCT00842244|Secondary|Apparent Volume of Distribution (Vz/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Vz/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because Vz/F could not be accurately estimated.|||Liter||95% Confidence Interval|Geometric Mean
1451516|NCT00842244|Secondary|Clearance (CL) for Cisplatin|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of blood from which drug can be completely removed per unit of time. Clearance for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate) in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin alone) on Cycle 2 Day 1.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start on C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter/hr||95% Confidence Interval|Geometric Mean
1451517|NCT00842244|Secondary|Apparent Oral Clearance (CL/F) for Axitinib, Capecitabine and Capecitabine's Metabolites|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. CL/F for capecitabine in presence of steady-state axitinib was evaluated on Cycle 1 Day 1 and in absence of axitinib (capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose on C1D1, C2D1|Pharmacokinetic parameter analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' = participants evaluable for specified study drug's PK parameter alone or in combination. Results are not reported for capecitabine metabolites because CL/F could not be accurately estimated.|||Liter/hr||95% Confidence Interval|Geometric Mean
1451518|NCT00842244|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Plasma decay half life for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||hrs||Standard Deviation|Mean
1451519|NCT00842244|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time [AUC (0 - ∞)] for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. AUC (0 - ∞) for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1451520|NCT00842244|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] for Axitinib|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours. AUC (0-24) for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Results for axitinib were normalized to axitinib 5 mg dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
1451521|NCT00842244|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Capecitabine, Capecitabine's Metabolites and Cisplatin|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR, 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram*hour/milliliter (ng*hr/mL)||95% Confidence Interval|Geometric Mean
1451522|NCT00842244|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Tmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Tmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-FU, 5-DFUR and 5-DFC) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on C1D-1, C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||hrs||Full Range|Median
1451646|NCT00840632|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg*h/mL||Standard Deviation|Mean
1451523|NCT00842244|Secondary|Maximum Observed Plasma Concentration (Cmax) for Axitinib, Capecitabine, Capecitabine's Metabolites and Cisplatin|Cmax for axitinib in absence of chemotherapy (axitinib alone) was evaluated on Cycle 1 Day -1 and in combination with chemotherapy on Cycle 1 Day 1. Cmax for cisplatin (assessed by estimating total platinum in plasma ultrafiltrate), capecitabine and capecitabine’s metabolites (5-fluorouracil [5-FU], 5-deoxy-5-fluorouridine [5-DFUR] and 5-deoxy-5-fluorocytidine [5-DFC]) in presence of steady-state axitinib were evaluated on Cycle 1 Day 1 and in absence of axitinib (cisplatin/capecitabine alone) on Cycle 2 Day 1. Results for axitinib were normalized to axitinib 5 mg dose, results for capecitabine and its metabolites (5-FU, 5-DFUR and 5-DFC) were normalized to Cycle 1 Day 1 capecitabine dose and results for cisplatin were normalized to Cycle 1 Day 1 cisplatin dose.|0 (pre-dose), 1, 2, 3, 4, 6, 8 hrs post-axitinib dose on Cycle 1 (C1) Day -1 (D-1), C1D1; 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 hrs post-capecitabine dose C1D1, C2D1; 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 hrs post-cisplatin infusion start C1D1, C2D1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, 'n' signifies those participants who were evaluable for specified study drug's PK parameter alone or in combination.|||nanogram/milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1451524|NCT00842244|Other Pre-specified|Maximum Tolerated Dose (MTD) of Axitinib (AG-013736) in Combination With Cisplatin and Capecitabine|MTD = highest dose at which no more than 30 percent (%) of 12 participants experience DLT during Cycle 1. DLT = GR2 proteinuria; GR3 NHT (excluding alopecia and those that can be controlled with appropriate treatment)for >=7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile NP/NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment-related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.|||mg|||Number
1451525|NCT00842244|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)|DLT = Grade (GR) 2 proteinuria; GR3 nonhematological toxicity (NHT) (excluding alopecia and those that can be controlled with appropriate treatment) for greater than or equal to (>=)7 days, GR3 thrombocytopenia with active bleeding; GR >=3 febrile neutropenia (NP) or NP infection; GR 3 or 4 nausea, vomiting or diarrhea despite anti-emetics, anti-diarrheals; GR4 NHT, thrombocytopenia, NP for >=7 days; >= 1/2 teaspoon per day hemoptysis; any treatment related toxicity with >3 consecutive days of capecitabine or 5 consecutive days of axitinib missed doses per cycle; delayed toxicity recovery >14 days.|Baseline up to Day 21 of Cycle 1|DLT analysis set: participants who received first cycle of study treatment and did not temporarily or permanently discontinue or miss more than 5 consecutive days of axitinib (AG-13736) or more than 3 consecutive days of capecitabine for reasons other than DLTs within first cycle.|||participants|||Number
1451526|NCT00842231|Primary|Reading Acuity and Speed|Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD).|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.|||words per minute||95% Confidence Interval|Least Squares Mean
1451527|NCT00842231|Primary|Contrast Sensitivity|Contrast Sensitivity (CS) differences between subjects tested with full correction & spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) & mesopic conditions (with & without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS.|Day of Study Visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.|||Logrithmic Units||Standard Deviation|Mean
1451528|NCT00842231|Primary|High and Low Contrast Acuity|Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision).|Day of study visit|Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected.|||logMAR||Standard Deviation|Mean
1451529|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 4|ITT Population||||||
1451530|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)|Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 4 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||Percent change in scores on a scale||Standard Deviation|Mean
1451647|NCT00840632|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg*h/mL||Standard Deviation|Mean
1451531|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for Subject Global Assessment were evaluated; not all participants returned for every study visit.|||participants|||Number
1451532|NCT00842153|Secondary|Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of plaque thickness in participants as: 0=no elevation over normal skin; 1=possible but difficult to ascertain whether there is a slight elevation above normal skin; 2=slight but definite elevation, typically edges are indistinct or sloped; 3=moderate elevation with rough or sloped edges; 4=marked elevation typically with hard or sharp edges; and 5=very marked elevation typically with hard, sharp edges.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for plaque thickness were evaluated; not all participants returned for every study visit.|||participants|||Number
1451533|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for scaling were evaluated; not all participants returned for every study visit.|||participants|||Number
1451534|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Baseline (Week 0) and Week 4|ITT Population. Participants who returned for the visit specified (Week 4) and/or provided an assessment for erythema were evaluated; not all participants returned for every study visit.|||participants|||Number
1451535|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Baseline (Week 0) and Week 4|ITT Population Participants who returned for the visit specified (Week 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||participants|||Number
1451536|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Week 1 and Week 4|ITT Population. Participants who returned for the visit specified (Week 1 and/or 4) and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.|||participants|||Number
1451537|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected|Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100. Data for this outcome measure were not collected; thus, no data were analyzed.|Baseline (Week 0) and Week 2|ITT Population||||||
1451538|NCT00842153|Secondary|Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)|Participants assessed their level of pruritus (itching) for the target lesion using a 10 centimeter (cm) Visual Analogue Scale (VAS) with the left side anchored with “0=None” and the right side anchored with “10=Very Severe.” A target lesion (>2 cm squared [cm^2]) was considered to be one on the trunk or extremities (excluding palms/soles, elbows, or knees). Percent change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0) divided by the Baseline (Week 0) value * 100.|Baseline (Week 0) and Week 2|ITT Population. Participants who returned for the visit specified (Week 2) and/or provided an assessment of pruritis were evaluated; not all participants returned for every study visit.|||Percent change in scores on a scale||Standard Deviation|Mean
1451539|NCT00842153|Secondary|Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2|Participants assessed all treated areas using the Subject Global Assessment scale: 0=skin completely clear, possible residual hyperpigmentation; 1=psoriasis almost clear, patchy remnants of fine scaling present; 2=psoriasis mild, with small amount of psoriasis remaining (i.e., fine to coarse scales in some areas, definite redness, barely visible plaque thickness); 3=psoriasis moderate, between slight and definitely noticeable; 4=psoriasis very noticeable with redness, scaling, plaque thickness; 5=psoriasis severe with severe redness, thick scaling, and plaques.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
1451541|NCT00842153|Secondary|Number of Participants With a Scaling Score of 0 or 1 at Week 2|The investigator individually graded the severity of scaling in participants as: 0=no scaling; 1=no evidence of scaling; 2=minimal, occasional fine scale over less than 5% of the lesion; 3=mild, fine scales predominate; 4=moderate, coarse scales predominate; and 5=marked, thick nontenacious scales predominate.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
1451542|NCT00842153|Secondary|Number of Participants With an Erythema Score of 0 or 1 at Week 2|The investigator individually graded the severity of erythema (redness of skin) in participants as: 0=hyperpigmentation, pigmented macules (flat, distinct, colored area of skin), diffuse faint pink or red coloration; 1=no evidence of erythema, hyperpigmentation present; 2=faint erythema; 3=light red coloration; 4=moderate red coloration; and 5=bright red coloration.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
1451543|NCT00842153|Secondary|Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2|Participants assessed their level of pruritus (itching) over the previous 24-hour period using the following scale: 0=no itching; 1=minimal, very rarely aware of localized itching, present when relaxing and lasted for very short time; 2=mild, aware of itching at times, present when relaxing, not present when focused on other activities; 3=moderate, often aware of itching, annoying, sometimes disturbed sleep and daytime activities; and 4=severe, constant itching, distressing, frequent sleep disturbance, interfered with activities.|Week 2|ITT Population. Participants who returned for the visit specified (Week 2) were evaluated; not all participants returned for every study visit.|||participants|||Number
1451544|NCT00842153|Secondary|Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|ITT Population. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.|||participants|||Number
1451545|NCT00842153|Primary|Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4|The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.|Weeks 1, 2, and 4|Intent-to-Treat (ITT) Population: all enrolled participants. Participants who returned for the visit specified (Week 1, 2, and/or 4) were evaluated; not all participants returned for every study visit.|||participants|||Number
1451546|NCT00842075|Secondary|Weight Change After 28 Days Intervention Period|Mean weight change after 28 days intervention period|28 days||||kg||Standard Deviation|Mean
1451547|NCT00842075|Primary|HbA1c Value After 28 Days|HbA1c values 28 days after randomization|28|pilot study|||HbA1c %||Standard Deviation|Mean
1451548|NCT00842023|Other Pre-specified|Serum Levels of Cystatin-C|Cystatin-C is a protease inhibitor and a sensitive endogenous marker of renal function.|Baseline, 24 hours, 48 hours|Only participants with available data were assessed for this outcome measure.|||ng/mL||Standard Deviation|Mean
1451549|NCT00842023|Other Pre-specified|Inflammatory Markers|Interleukin-6|48 hours|Only participants with available data were assessed for this outcome measure.|||pg/mL||Standard Error|Mean
1451550|NCT00842023|Primary|Renal Function by Serum Creatinine|Serum creatinine values and changes in serum creatinine|Baseline, 24 hours, 48 hours||||mg/dL||Standard Deviation|Mean
1451551|NCT00841971|Secondary|Need for Additional Antifungal Therapy||90 days post enrollment||||participants|||Number
1451552|NCT00841971|Primary|Frequency of Fungal Infection||90 days post enrollment||||participants|||Number
1451553|NCT00841906|Secondary|The Secondary Objective of This Study is to Compare the Measurements of the Alice PDx When Patients Complete the Set-up of the Device at Home and When Patients Are Set up by a Sleep Technician in the Sleep Laboratory.|"The Alice PDx incorporates a unique Good Study Indicator (GSI). The GSI is a predicated on airflow and oximeter signal quality and displays the amount of good quality data needed for a study to be complete and valid. The GSI visually displays the amount of good quality data in 25-percent increments on the Alice PDx screen. For purposes of this secondary objective this number was compared from participants who set-up and wore the device at home and those that wore the device in a sleep lab set up by a sleep technician."|overnight||||percentage of good Study Indicator||Standard Deviation|Mean
1451554|NCT00841906|Primary|This Study Will Compare Different Measurements Recorded by the Alice PDx to the Measurement Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.|This study will compare different measurements recorded which include Time in Bed, Stage N1, Stage N2, Stage N3, REM, Sleep Onset Latency, Total Sleep Time, Wake Time in Bed and Wake After Sleep Onset by the Alice PDx to the measurement data recorded by its predicate device the Alice 5 System and validate its equivalence.|Lab Night|All participants that completed the overnight portion of the study were analyzed.|||minutes||Standard Deviation|Mean
1451555|NCT00841906|Primary|This Study Will Compare the Central Apnea Index, Hypopnea Index, Mixed Apnea Index and Obstructive Apnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.||Lab Night|All participants that completed the overnight portion of the study were analyzed.|||events/hour||Standard Deviation|Mean
1451556|NCT00841906|Primary|This Study Will Compare the Apnea Hypopnea Index Recorded by the Alice PDx to the Physiological Data Recorded by Its Predicate Device the Alice 5 System and Validate Its Equivalence.||Lab Night|All participants that completed the overnight portion of the study were analyzed.|||events||Standard Deviation|Mean
1451557|NCT00841815|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
1451558|NCT00841815|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
1451566|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titers from baseline as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis Set population.|||Percentages of participants||95% Confidence Interval|Number
1451567|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2 as determined by HI, MN and SRH assays.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.|||Percentages of participants||95% Confidence Interval|Number
1451568|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 Vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Ratios (GMRs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI,MN and SRH assays.|3 weeks after vaccination (day 43/day 22 and day 64/day 22)|This analysis was performed on the Full Analysis set population.|||Ratios||95% Confidence Interval|Geometric Mean
1451569|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|"To evaluate the immunogenicity of two doses of MF59-eH5N1, each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Areas (GMAs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis Set population.|||Areas (mm^2)||95% Confidence Interval|Geometric Mean
1451570|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Titers (GMTs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.|3 weeks after vaccination (day 22, day 43, day 64)|This analysis was performed on the Full Analysis set population.|||Titers||95% Confidence Interval|Geometric Mean
1451571|NCT00841763|Secondary|Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titer from baseline, as measured by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22 and day 64/day22)|This analysis was performed on the Full Analysis Set population|||Percentages of participants||95% Confidence Interval|Number
1451572|NCT00841763|Secondary|Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain)|"To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2, as determined by HI, MN and SRH assays.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Percentages of participants||95% Confidence Interval|Number
1451573|NCT00841763|Secondary|Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Ratio(GMRs) against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.|3 weeks after vaccination (day 43/day22, day 64/day43)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Ratios||95% Confidence Interval|Geometric Mean
1451574|NCT00841763|Secondary|Geometric Mean Areas After Two Doses of the Adjuvanted Monovalent Influenza Virus Vaccine (aH5N1)|"To evaluate the immunogenicity of two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1), in terms of Geometric Mean Areas (GMAs) as determined by Single Radial Haemolysis(SRH) assay.~GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64."|3 weeks after vaccination (day22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Areas (mm^2)||95% Confidence Interval|Geometric Mean
1451575|NCT00841763|Secondary|Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain|To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Titers(GMTs) against the homologous A/Vietnam/1194/2004 strain, as determined by hemagglutination Inhibition(HI) assay and Microneutralization(MN) assay.|3 weeks after vaccination (day 22, day 43, day 64)|The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.|||Titers||95% Confidence Interval|Geometric Mean
1452287|NCT00835185|Secondary|Cmax at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Cmax results were not collected.||||||
1451576|NCT00841763|Secondary|The Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine|To evaluate the safety and tolerability profile of two dose of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV), in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety set population|||Participants|||Number
1451577|NCT00841763|Primary|Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine|To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) pandemic influenza vaccine (MF59-eH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.|Up to 7 days after each vaccination|The analysis was performed on the Safety Set population|||Participants|||Number
1451578|NCT00841698|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451579|NCT00841698|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451580|NCT00841698|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451581|NCT00841672|Secondary|Blood Pressure Control|Percentage of patients achieving blood pressure control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at end of study|End of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues|||Percentage of participants|||Number
1451582|NCT00841672|Secondary|Diastolic Blood Pressure Response|Percentage of patients achieving a mean sitting diastolic blood pressure response (msDBP < 90 mmHg or a reduction ≥ 10 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues All randomized patients who received the study medication. The measurement at Week 8 was used unless it was not available, in which case, the last observation carried forward was used.|||Percentage of participants|||Number
1451583|NCT00841672|Secondary|Systolic Blood Pressure Response|Percentage of patients achieving a mean sitting systolic blood pressure response (msSBP < 140 mmHg or a reduction => 20 mmHg from the baseline) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to GCP issues|||Percentage of participants|||Number
1451584|NCT00841672|Secondary|Mean Sitting Diastolic Blood Pressure (msDBP)|Change in mean sitting diastolic blood pressure (msDBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues|||mm Hg||Standard Error|Least Squares Mean
1451585|NCT00841672|Primary|Mean Sitting Systolic Blood Pressure (msSBP)|Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)|Baseline to end of study (Week 8)|Full Analysis Set - analysis set was the FAS excluding patients from one center due to Good Clinical Practices (GCP) issues|||mm Hg||Standard Error|Least Squares Mean
1451586|NCT00841659|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451587|NCT00841659|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451588|NCT00841659|Primary|Cmax - Maximum Observed Concentration (of Paroxetine in Plasma)|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451589|NCT00841568|Primary|Renal Function Test (eGFR)|Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period.|Baseline, Week 24, 48, 108, and 156||||mL/min/1.73m2||Inter-Quartile Range|Median
1451590|NCT00841568|Primary|Total Kidney Volume|Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period.|Baseline, week 24, 52, 104, and 156||||mL||Inter-Quartile Range|Median
1451591|NCT00841555|Secondary|Time Spent in a Karnofsky Performance Status of 60-100%|Time spent in a KPS ≥70 was calculated from the date of diagnosis of Karonofsky Performance Status decline (KPS<70) or censored at the last date the patient was known with KPS ≥70. The KPS higher scores indicates normal activity status.|up to 12-16 months|Kaplan-Meier analysis for time spent in a Karnofsky performance status (KPS) ≥70|||months||95% Confidence Interval|Median
1451592|NCT00841555|Secondary|Survival Time|All patients will be followed to death. Active follow-up with disease evaluation with scans will be terminated if the patient’s physician deems it in the patient’s interest not to continue or upon patient request.|up to 2 years||||months||95% Confidence Interval|Median
1451593|NCT00841555|Secondary|Time to Neuroradiological Evidence of Tumor Recurrence or Progression|As a small phase I study, no inferential statistical tests of hypotheses are planned. Data collected will be providing descriptive summary statistics. However, these estimates will allow statistically sound experimental designs and sample size calculations for subsequent studies of therapeutic effect.|up to 12-16 months|||||||
1451648|NCT00840632|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg/mL||Standard Deviation|Mean
1451594|NCT00841555|Primary|Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)|This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect.|up to 12-16 months||||mg/m^2|||Number
1451595|NCT00841542|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451596|NCT00841542|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451597|NCT00841542|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451598|NCT00841412|Primary|Quality of Feeding Assistance Care Processes|"Research staff observed each participant during six meals per study phase. Research staff documented the total amount of staff time spent providing feeding assistance and each type of assistance per resident per meal. These data were used to construct standardized feeding assistance care quality indicators wherein the number of resident meal observations was variable. For example, one indicator was defined as: Percentage of meals during which resident intake was below 50% and staff offered and alternative to the served meal. Thus, the denominator for total number of observed meals scored varied by indicator. There were multiple indicators; thus, there is inadequate space to provide an adequate description of each measure and the corresponding scoring rules here. Please refer to published papers for a complete description of all outcome measures."|3 month intervention and 3 month follow up periods|Each participants was observed during six scheduled meals per person per study phase. A total of 130 participants completed all study phases and had complete data for analyses.|||percentage of meal observations|Participants||Number
1451599|NCT00841321|Secondary|Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration.|"The Perceived Deficits Questionnaire (PDQ), a standardized questionnaire in which the subject reports on his or her cognitive function; Measure total score Range (0 best - 80 worse) Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ), in which the family member who was most aware of the participant's cognitive deficits reports on the subject's cognitive deficits; measure total score range (0 best - 60 worse) 'and the Community Integration Questionnaire (CIQ) in which the subject reports his or her degree of social integration; range (0 worst - 32 best); measure total score.~Sub-scales for these 3 measures were not used for outcome measures only total scores."|12 weeks||||units on a scale||Standard Deviation|Mean
1451600|NCT00841321|Primary|Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.|"Performance at exit adjusted for baseline performance on 4 neuropsychological tests:~STROOP(Victoria version):Tests attention&executive function. Outcome is the interference condition condition; time needed to name the colors in which words (which are names of colors) are printed. Words and colors are mismatched.~CaliforniaVerbalLearningTest- II: Tests verbal/learning/memory. Outcome number of words (shopping list) remembered after 20 min delay with no cues.~PacedAuditorySerialAdditionTest:Tests working memory/sustained attention. Outcome is the number of correct responses to recording giving numbers every 2 sec. Last 2 numbers must be added together before the next number.~ControlledOralWordAssociationTest:Tests letter fluency. Outcome number of words produced in one minute for each of 3 letters.~Measures reported as Z-scores based on the available population norms for each test; range -infinite +infinite; 0 average; -1=1std below average; +1=1std above average."|12 weeks|Data of all 120 participants was analyzed. For subjects with missing exit values (1 placebo, 2 ginkgo) the baseline measures were carried forward in the analysis.|||z-scores||Standard Deviation|Mean
1451601|NCT00841269|Secondary|A Secondary Outcome Measure Includes a Change in Young Mania Rating Scale (YMRS) Score|The Young Mania Rating Scale (YMRS) is an 11-item rating scale that evaluates manic symptoms. Total scores range from 0-60, with higher scores indicating more manic symptoms endorsed by research participants.|6 weeks||||units on a scale||Full Range|Mean
1451602|NCT00841269|Primary|The Primary Neuroimaging Outcome Will be Changes in Beta-NTP to TP (Total Phosphorus) Ratio in the Anterior Cingulate.||6 weeks||||Beta-NTP/TP Ratio||Standard Deviation|Mean
1451603|NCT00841269|Primary|Mean Scores in Children's Depression Rating Scale (CDRS-R), Assessed Before and After 6 Week Uridine Treatment|The CDRS-R is a 17-item scale, with items rated for severity on a 5 point scale for 3 items and on a 7 point scale for 14 items (possible total score from 17 to 113). Ratings are completed by a clinician via interviews with the child or parent. Scores ≥40 are indicative of depression, whereas scores ≤28 is often used to define remission.|6 weeks||||Units on a scale||Full Range|Mean
1451604|NCT00841204|Secondary|Association Between Plasma and Target Tissue Sulindac Sulfide Levels||8 weeks|The correlation between plasma and target tissue sulindac sulfide levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.|||correlation coefficient|||Number
1451605|NCT00841204|Secondary|Association Between Plasma and Target Tissue Sulindac Sulfone Levels||8 weeks|The correlation between plasma and target tissue sulindac sulfone levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.|||correlation coefficient|||Number
1451606|NCT00841204|Secondary|Association Between Plasma and Target Tissue Sulindac Levels||8 weeks|The correlation between plasma and target tissue sulindac levels was analyzed for Arm I only because participants in Arm 2 did not have any measurable drug levels.|||correlation coefficient|||Number
1451607|NCT00841204|Secondary|Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi|Change in VEGF expression in melanocytic junctional component|Baseline and 8 weeks||||% of stained cells * intensity score||Inter-Quartile Range|Median
1451614|NCT00841087|Secondary|Electrocardiogram (ECG)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||participants|||Number
1451615|NCT00841087|Secondary|Change in Body Weight|Observed change from baseline in body weight after 6 weeks of treatment|Week 0, Week 6|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||kg||Standard Deviation|Mean
1451616|NCT00841087|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject’s daily activities. Moderate: marked symptoms, moderate interference with subject’s daily activities. Severe: considerable interference with subject’s daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
1451617|NCT00841087|Primary|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes|Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00−05:59 (both inclusive).|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
1451618|NCT00841087|Primary|Rate of Major and Minor Hypoglycaemic Episodes|Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.|Week 0 to Week 6 + 5 days follow up|The Safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes /year of patient exposure|||Number
1451619|NCT00841035|Primary|Epidermal Growth Factor Receptor Signaling(EGFR) in the Presence of Pancreatic Tumor Related to the Mechanism to Erlotinib.|It was our belief that we would need a comprehensive analysis of a dynamic panel of biomarkers relevant to EGFR signaling as well as the erlotinib mechanism of action it seems more useful in that sense. Furthermore,the ability limited of pancreatic cancer tissue sampling precluded biomarker correlation assays.These could not be worked out in either a xenograft model or in in-vitro conditions.|During the trial only|||||||
1451620|NCT00841035|Secondary|The Secondary Objectives Include Analysis of Recurrence-free and Overall Survival and the Development of a Predictive Assay for Response to Erlotinib Based on Selected Bio-markers in Endoscopic Ultrasound-Fine-needle Aspiration Specimens.|The measurement was to be the average length of time before recurrence of disease and the overall survival time. As well as time from recurrence to death in subjects.This time will be measure in months till recurrence and them months to death.|End of the study|Due to the closure of the study before this endpoint could be met, there are no subjects analyzed.||||||
1451621|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|90 days post operative|Include the participants who finished the Acute SF 12 health survey at 90 days follow-up|||units on a scale||Inter-Quartile Range|Median
1451622|NCT00840996|Secondary|12-item Short Form Survey (SF-12) Physical Health Composite Score|Physical health composite score ranges from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|30 days post operative|Include the participants who finished the Acute SF 12 health survey at 30 days follow-up|||units on a scale||Inter-Quartile Range|Median
1451623|NCT00840996|Secondary|Duration of Hospitalization|Length of hospital stay will be recorded in days.|At discharge|3 patients in the placebo group did not have duration of hospital stay recorded.|||days||Inter-Quartile Range|Median
1451624|NCT00840996|Secondary|Postoperative Nausea and Vomiting (PONV)|Postoperative Nausea and Vomiting (PONV)will be noted during day one and day two postoperative.|post op day one and two or till hospital discharge|We only have 39 and 36 patients for comparison of PONV at day two after surgery, since the rest were discharged by that time|||participants|||Number
1451625|NCT00840996|Secondary|Number of Participants With Any Major 30-day Post Operative Complications|The occurrence in an individual of one or more the following major complications, including pneumonia, respiratory failure, prolonged use or need for reinsertion of chest tube, cardiac arrest, arrhythmia, congestive heart failure, stroke, intravascular coagulopathy, thromboembolic disease (pulmonary embolism), injury to great vessels, delirium, monoplegia or paraplegia, upper gastrointestinal bleeding, gastrointestinal block, ureteral obstruction, syndrome of inappropriate antidiruretic hormone secretion, wound infection requiring debridement, sepsis, and readmission.|30 days after surgery||||participants|||Number
1451626|NCT00840996|Primary|Opioid Medication Requirement, mg in IV Morphine Equivalent|Opioid consumption during the initial 48 postoperative hours was converted to IV morphine sulfate equivalents|through postoperative day 2 (or discharge, if earlier)||||mg IV morphine equivalent||Standard Deviation|Mean
1451627|NCT00840996|Primary|Mean Pain Scores|The pain score as measured by verbal response scores (scale ranging from 0 to 10 with 0=no pain; 10=worst pain) every 30 minutes during post anesthesia care unit stay, then per nursing floor protocol (roughly every 4-6 hours).|From admission to the post anesthesia care unit through postoperative day 2 (or discharge, if earlier).||||verbal response scores||Standard Deviation|Mean
1451628|NCT00840879|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
1451629|NCT00840879|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.|||µg*h/mL||Standard Deviation|Mean
1451630|NCT00840879|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.|||µg/mL||Standard Deviation|Mean
1451631|NCT00840866|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1451632|NCT00840866|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1451633|NCT00840866|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1451634|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/h/mL||Standard Deviation|Mean
1451635|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451636|NCT00840840|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451637|NCT00840840|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451638|NCT00840840|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451639|NCT00840840|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451640|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the a) Proportional Odds of Higher Receptive Needle Sharing and b) Mean Score of the Injection Risk Index (IRI).|"For a) we asked: “In the past month, how often have you used a needle or syringe that you knew or suspected had been used before by someone else?” (possible responses: 1=never, 2=sometimes, 3=about half the time, 4=often, 5=always), with a higher response indicating a higher risk.~Analyzed using ordinal logistic regression with frequency of receptive needle sharing as outcome variable and intervention group, time point, and interaction between the two as main effects of interest.~For b)IRI calculated based on: receptive needle sharing, sharing a bottlecap/spoon/cooker, sharing cotton filter for a needle, or rinse water after someone else has used it, and using a used syringe to divide drugs. Score constructed by calculating average score between responses to injection risk indicators, with higher score representing higher risk. We analyzed using gamma regression with IRI as outcome and intervention group, time point and interaction between the two as main effects of interest"|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||2012-11-30|11/2012||||
1451641|NCT00840658|Secondary|Change (Baseline to 4-, 8-, and 12-months) in the a)Mean Number of Unprotected Sex Acts With Clients and b)Ratio of Unprotected Sex Acts With Clients (Relative to the Number of Sex Acts With Clients.|The analytic method used for a) was negative binomial regression with the number of unprotected sex acts with clients as the outcome variable and intervention group, time point (baseline, 4-, 8-, and 12-months), and the interaction between the two as the main effects of interest. Similarly, for part b) we used negative binomial regression, except that in this case log(total number of sex acts with clients) was used as an offset variable in order to create the ratio of unprotected sex acts (relative to total number of sex acts).|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||2012-11-30|11/2012||||
1451642|NCT00840658|Primary|Combined HIV/STI 12-month Incidence Rates of HIV, Syphilis, Chlamydia, Gonorrhea and Trichomonas Vaginalis.|"Combined incidence for HIV/STI was calculated over the 12-month study period and included only those who a) had at least one follow-up visit and b) at baseline tested negative for HIV and any of the aforementioned STIs.~In the calculations we accounted for the time each participant spent at risk of HIV/any STI during the follow-up period, by using available information on each participant for each time point (i.e. baseline, 4-, 8-, and 12-months was used).~The analytic method used for this outcome analysis was Poisson regression with robust variance estimation. The outcome variable was a binary variable indicating whether a participant has contracted HIV or a new STI during the 12-month follow-up period. The primary factor of interest was the intervention group. The log (“time spent at risk of HIV/any STI”) was used as an offset variable in order to account for the time spent at risk of HIV/any STI by each participant."|12 months, with measuring points at baseline and at 4, 8, and 12 months past baseline||||incidence density per 100 person years|||Number
1451643|NCT00840632|Secondary|AUC0-t - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period||||pg*h/mL||Standard Deviation|Mean
1451644|NCT00840632|Secondary|AUC0-inf - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period||||pg*h/mL||Standard Deviation|Mean
1451645|NCT00840632|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period||||pg/mL||Standard Deviation|Mean
1451649|NCT00840476|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.|||µg*h/mL||Standard Deviation|Mean
1451650|NCT00840476|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.|||µg*h/mL||Standard Deviation|Mean
1451651|NCT00840476|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.|||µg/mL||Standard Deviation|Mean
1451652|NCT00840450|Secondary|Progression-free-survival at 12 Months|This defined as the percentage of participants who had progression free survival at 12 months from the beginning of the treatment.|up to 12 months|Based on intent-to-treat population.|||percentage of participants|||Number
1451653|NCT00840450|Secondary|Progression-free-tolerance|This is defined as the percentage of participants who continued on treatment with no progression at 12 weeks since the start of treatment.A patient will be considered to have progression-free-tolerance if she does not drop out due to toxicity and does not have disease progression or die by the completion of 12 weeks on treatment.|12 weeks|Based on intent-to-treat population.|||percentage of participants|||Number
1451654|NCT00840450|Primary|the Best Overall Clinical Response|This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.|12 weeks|The analysis is based on the intent-to-treat population.|||percentage of participants|||Number
1451655|NCT00840411|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451656|NCT00840411|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|AUCinf could not be estimated for some subjects.|||ng*h/mL||Standard Deviation|Mean
1451657|NCT00840411|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451658|NCT00840307|Primary|Pancreatic and Liver Triglyceride (Fat) Content|Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).|months after the first band inflation||||percent||Inter-Quartile Range|Median
1451659|NCT00840294|Secondary|Overall Infectious Complication Rate Following Prostate Biopsy|To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy|Within 24 hours of biopsy|Subjects with complete data are included.|||percentage of participants||95% Confidence Interval|Number
1451660|NCT00840294|Primary|Change in PSA Level From Baseline|"To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization.~Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline)."|At baseline and 21-45 days after randomization|Subjects with complete data are included|||log ng/mL||Standard Deviation|Mean
1451661|NCT00840281|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.||||ng*h/mL||Standard Deviation|Mean
1451662|NCT00840281|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.||||ng*h/mL||Standard Deviation|Mean
1451663|NCT00840281|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1451664|NCT00840216|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451665|NCT00840216|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451666|NCT00840216|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451667|NCT00840203|Secondary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|AUC0-t results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451668|NCT00840203|Secondary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|AUC0-inf results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects|||ng*h/mL||Standard Deviation|Mean
1451669|NCT00840203|Secondary|Cmax - Maximum Observed Concentration|Cmax results for N-Acetylmesalamine metabolite|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452246|NCT00835367|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451670|NCT00840203|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451671|NCT00840203|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|AUC0-inf was not able to be estimated for all completing subjects|||ng*h/mL||Standard Deviation|Mean
1451672|NCT00840203|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451673|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Clavulanic Acid|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451674|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Clavulanic Acid|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451675|NCT00840099|Primary|Bioequivalence Based on Cmax for Clavulanic Acid|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451676|NCT00840099|Primary|Bioequivalence Based on AUC0-t for Amoxicillin|AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451677|NCT00840099|Primary|Bioequivalence Based on AUC0-inf for Amoxicillin|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451678|NCT00840099|Primary|Bioequivalence Based on Cmax for Amoxicillin|Cmax - Maximum Observed Concentration|Blood samples collected over 14 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451679|NCT00840086|Secondary|Frequency of Adverse Events (AEs)|Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient’s daily activities. Mild AEs: No or transient symptoms, no interference with the patient’s daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject|Safety analysis set includes all subjects who received at least one dose of the investigational product.|||events|||Number
1451680|NCT00840086|Primary|The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))|The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.|The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.|The safety analysis set includes all 150 subjects who received at least one dose of the investigational product. The analysis of the primary endpoint included all subjects with at least 50 exposure days and/or with inhibitors. A total of 148 subjects had 50 exposure days (EDs).|||N with Inhibitors / N with ≥50 EDs|||Number
1451681|NCT00840073|Secondary|AUC0-72 - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng*h/mL||Standard Deviation|Mean
1451682|NCT00840073|Secondary|Cmax - Trandolaprilat|Informational Purposes Only|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng/mL||Standard Deviation|Mean
1451683|NCT00840073|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng*h/mL||Standard Deviation|Mean
1451684|NCT00840073|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all data from completed subjects could be used to determine AUC0-inf.|||ng*h/mL||Standard Deviation|Mean
1451685|NCT00840073|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.|||ng/mL||Standard Deviation|Mean
1451686|NCT00840060|Primary|Number of Verb Structures Per Utterance|Samples were transcribed and segmented by utterance. Utterances were analyzed for novel verb structures. Structures were included if they were produced more than one time.|Pre-treatment, post-treatment, 1-month follow-up||||Novel verb structures per utterance||Standard Deviation|Mean
1452138|NCT00836004|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451687|NCT00840060|Primary|Language Sample Analysis|Samples were transcribed and segmented by utterance. Each was coded categorically. Reported measures include percentage of utterances at the interpretive/inferential label, percentage of utterances with one or more t-unit (i.e., noun phrase + verb phrase), percentage of utterances that required copula (is/are) or auxiliary (is/are) that were produced.|Language samples were obtained pre-treatment, post-treatment, and at one-month follow-up.|Language samples were collected for all children participating in either treatment condition.|||Percentage of utterances||Standard Deviation|Mean
1451688|NCT00840034|Other Pre-specified|Change From Baseline to 8 Weeks in Supine Pulse|Pulse is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and included all participants who have baseline and at least 1 post-baseline supine pulse rate measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1451689|NCT00840034|Other Pre-specified|Change From Baseline to 8 Weeks in Supine Systolic and Diastolic Blood Pressure|Blood pressure is collected while the participant is in the supine position. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who have baseline and at least 1 post-baseline supine systolic and diastolic blood pressure measure.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
1451690|NCT00840034|Secondary|Colombia-Suicide Severity Rating Scale (C-SSRS)|"Percent of participants with suicidal ideation, behavior and acts based on C-SSRS. The C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior: a yes answer to any 1 of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide). Suicidal ideation: a yes answer to any 1 of 5 suicidal ideation questions (wish to be dead, and 4 different categories of active suicidal ideation). Suicidal act: a yes answer to actual attempt or completed suicide."|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline C-SSRS Score.|||percentage of participants|||Number
1451691|NCT00840034|Secondary|Change From Baseline to 8 Weeks Massachusetts General Hospital Sexual Functioning Questionnaire (MGH-SFQ)|The MGH-SFQ is a 6-item participant-rated scale quantifying sexual interest, arousal (subjective excitement), ability to reach orgasm, erectile function (for males), and overall satisfaction and are scored on a 6-point scale: 1 (greater than normal) to 6 (totally absent); and overall improvement since last medication change is scored on a 6-point scale: 1 (very much improved) to 6 (much worse). Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MGH-SFQ Score.|||units on a scale||Standard Error|Least Squares Mean
1451692|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Quality of Life Enjoyment and Satisfaction Survey-Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week, and is rated on a 5-point Likert scale: 1 (very poor) to 5 (very good). The Q-LES-Q-SF Total Raw Score is the sum of Items 1 to 14 and ranges from 14 to 70. The Q-LES-Q-SF Raw Scores are converted to, and expressed as the percentage of the maximum possible score. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline Q-LES-Q-SF Total Score; last observation carried forward. If ≤2 items are missing mean of all other items are imputed.|||percentage of the maximum possible score||Standard Error|Least Squares Mean
1451693|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Sheehan Disability Scale (SDS)|The SDS is a 3-item, participant completed assessment and is used to assess the effect of the participant's symptoms on their work/social/family life. The Global Functional Impairment Total Score is a total of the 3 individual item scores, each with a scores range from 0 (not at all) to 10 (extremely). The Global Functional Impairment Total Scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat analysis is determined by treatment group participants are randomly assigned regardless of treatment received, includes all participants who do not respond in Weeks 1-2, have baseline and at least 1 post-baseline SDS Total Score; last observation carried forward. Missing work score imputed with average of other 2-item scores.|||units on a scale||Standard Error|Least Squares Mean
1451694|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Visual Analog Scale for Pain (VAS-P)|VAS-P is a self-rated assessment for 2 items: the overall severity of pain and the interferences with daily activities due to pain. For the overall severity of pain the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to pain, the participant is asked to place a vertical mark on a 100-mm line between 2 anchors: 0 (not at all) and 100 [complete disability (unable to do any activities)]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-P Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1451695|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Visual Analog Scale for Fatigue (VAS-F)|VAS-F is a self-rated assessment on 2 items: the overall severity of fatigue and the interferences with daily activities due to fatigue. For the overall severity of fatigue the participant is asked to place a vertical mark on a 100 millimeter (mm) line between 2 anchors: 0 (not at all) and 100 (as severe as I can imagine). For the interference with daily activities due to fatigue, the participant is asked to place a vertical mark on a 100 mm line between 2 anchors: 0 (not at all) and 100 [complete disability (unable to do any activities)]. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline VAS-F Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1451696|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Fatigue Associated With Depression Participant-Reported Outcome (FAsD PRO)|The FAsD PRO is a 16-item participant-rated scale. Seven items ask how often the participants experience different aspects of fatigue with each item rated on a 5-point scale: 1 (Never) to 5 (Always). Nine items ask how often fatigue impacts various aspects of the participants lives with each item rated on a 5-point scale: 1 (Not at all) to 5 (Very much). The Fatigue Experience Score is the mean of Items 1-5, and 7, the Fatigue Impact Score is the mean of Items 8-12, 14, and 16, and the Overall Average Score is the mean of Items 1-5, 7-12, 14 and 16. The Experience, Impact and Overall Mean Scores range from 1 to 5, lower scores indicate less experience/impact. Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline FAsD-PRO Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1451697|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42. Higher scores indicate greater disease severity. Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CPFQ Total Score.|||units on a scale||Standard Error|Least Squares Mean
1451698|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Clinical Global Impression of Severity (CGI-S)|CGI-S measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means are calculated using mixed model repeated measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline CGI-Severity Score.|||units on a scale||Standard Error|Least Squares Mean
1451699|NCT00840034|Secondary|Change From Baseline to 8 Weeks in Hospital Anxiety and Depression Scale (HADS)|HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for each subscale. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 is 'normal.' Least Squares (LS) means are calculated using analysis of covariance (ANCOVA) and adjusted for treatment, investigator, visit, treatment-by-visit, investigator, and baseline score.|Baseline, up to 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline HADS Score; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1451700|NCT00840034|Primary|Change From Baseline to 8 Weeks in Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS is a 10-item checklist with items rated on a scale of 0-6, for a total scores range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for investigator, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline MADRS Total Score.|||units on a scale||Standard Error|Least Squares Mean
1451701|NCT00840034|Secondary|Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Individual Items|QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). Least Squares (LS) means are calculated using mixed model repeated measure (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Individual Score.|||units on a scale||Standard Error|Least Squares Mean
1451702|NCT00840034|Secondary|Change From Baseline to 8 Weeks in 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) Total Score|QIDS-SR16 is a 16-item, participant-rated measure of depressive symptomatology with 4 possible answers per question that are specific to the question. Each question (Q) is scored from 0 (no problems) to 3 (increased symptoms). The total score for each visit is the sum of 9 of the 16 items: the highest number from Q1-4 (sleep), number from Q5 (feeling sad), highest number from Q6-9 (appetite and weight), total for Q10-14 (concentration, view of self, thoughts of death or suicide, general interest and energy level respectively) and the highest number from Q15-16 (psychomotor changes). The total score ranges from 0 to 27 with higher scores indicating greater severity of depression. Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) and adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, 8 weeks|Intent-to-treat population analysis is determined by the treatment groups to which participants are randomly assigned regardless of treatment received, and includes all participants who do not meet response criteria during Weeks 1-2, have baseline and at least 1 post-baseline QIDS-SR16 Total Score.|||units on a scale||Standard Error|Least Squares Mean
1451703|NCT00839982|Secondary|Overall Survival|Median overall survival|Up to 5 years||||median months||Full Range|Median
1451704|NCT00839982|Secondary|Disease Free Survival|Median disease-free survival|Up to 5 years||||median months||Full Range|Median
1451705|NCT00839982|Secondary|Treatment Response|CR = no evidence of leukemia with complete blood count recovery (ANC >1,000 and PLTS >100k) CRi = no evidence of leukemia but with incomplete blood count recovery|Up to 5 years||||Participants|||Count of Participants
1451706|NCT00839982|Primary|Maximum Tolerated Dose|We identified 20 mg/d for 5 d as the maximum tolerated dose (MTD) of oral clofarabine.|up to 5 years||||mg/day|||Number
1451707|NCT00839982|Primary|Number of Patients With Dose Limiting Toxicity|Dose limiting toxicity (DLT) consists of grade 3-4 non-hematologic toxicity at least possibly related to study drug. Exceptions include neutropenic fever; drug-related fever; alopecia; anorexia; inadequately treated nausea, vomiting and/or diarrhea; and grade 3/4 increase in ALT, AST, or bilirubin recovering to < grade 2 by 7 days. Prolonged grade 2 myelosuppression lasting longer than 49 days in patients who don't proceed to additional cytotoxic therapy is considered a DLT. The MTD or recommended phase II dose is the highest dose level at which no more than 1 patient out of 6 experiences DLT.|Outcomes by day 30||||Participants|||Count of Participants
1451708|NCT00839956|Secondary|Median Follow-up Survival for All Patients||Up to 5 years||||years||Full Range|Median
1451709|NCT00839956|Secondary|Survival for All Patients||Up to 5 years||||Participants|||Count of Participants
1451710|NCT00839956|Secondary|Time to Disease Progression in Patients Who Progressed|Patients will be followed for initial response to therapy and for progression of disease. Response criteria will be scored according to International Myeloma Working Group uniform response criteria.|Up to 5 years|One subject withdrew from the study within first week of study therapy and changed to different therapy and is not included in this outcome measure.|||years||Full Range|Median
1451711|NCT00839956|Primary|Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|The first three months of therapy will be used as the time period in which toxicity will be evaluated and stopping rules for unacceptable toxicity will be implemented. Rules for stopping the study will be based on the rate of withdrawal due to significant toxicity (grade IV, non-hematological, non-metabolic, nonperipheral neuropathy).|The first three months of therapy|No patients met stopping rules for significant toxicity in the first three months of therapy.|||Participants|||Count of Participants
1451712|NCT00839930|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451713|NCT00839930|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451714|NCT00839930|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451715|NCT00839917|Other Pre-specified|Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451716|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 5 days postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451717|NCT00839917|Other Pre-specified|Percentage of Participants With Injection-site Adverse Experiences|An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451732|NCT00839800|Secondary|Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)|An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of asthma-control days||Standard Deviation|Mean
1451718|NCT00839917|Other Pre-specified|Percentage of Participants With Any Systemic Adverse Experience|"An adverse experience is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences."|Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451719|NCT00839917|Other Pre-specified|Percentage of Participants With Zoster-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451720|NCT00839917|Other Pre-specified|Percentage of Participants With Rubella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451721|NCT00839917|Other Pre-specified|Percentage of Participants With Varicella-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451722|NCT00839917|Other Pre-specified|Percentage of Participants With Measles-like Rash||Through 6 weeks postvaccination|The safety population included all participants who received study vaccination|||percentage of participants|||Number
1451723|NCT00839917|Secondary|Geometric Mean Titer of VZV (gpELISA) Antibodies|Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||gpELISA units/mL||90% Confidence Interval|Geometric Mean
1451724|NCT00839917|Secondary|Geometric Mean Titer of Rubella Antibodies|Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||IU/mL||90% Confidence Interval|Geometric Mean
1451725|NCT00839917|Secondary|Geometric Mean Titer of Mumps Antibodies|Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||Units/mL||90% Confidence Interval|Geometric Mean
1451726|NCT00839917|Secondary|Geometric Mean Titer of Measles Antibodies|Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||mIU/mL||90% Confidence Interval|Geometric Mean
1451727|NCT00839917|Primary|Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL|Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1451728|NCT00839917|Primary|Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL|Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1451729|NCT00839917|Primary|Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL|Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1451730|NCT00839917|Primary|Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL|Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline|6 weeks postvaccination|Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
1451731|NCT00839800|Secondary|Asthma Control Questionnaire (ACQ)|The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||units on a scale||Standard Deviation|Mean
1451733|NCT00839800|Secondary|Percentage of As-needed-free Days|An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of as-needed-free days||Standard Deviation|Mean
1451734|NCT00839800|Secondary|Symptom-free Days (no Symptoms and no Awakenings)|A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||symptom-free days||Standard Deviation|Mean
1451735|NCT00839800|Secondary|The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations|Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of participants|||Number
1451736|NCT00839800|Secondary|Nights With Awakening(s) Due to Asthma Symptoms|The mean value from the treatment period was presented here.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Nights With Awakening(s)||Standard Deviation|Mean
1451737|NCT00839800|Secondary|Asthma Symptom Score|The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||units on a scale||Standard Deviation|Mean
1451738|NCT00839800|Secondary|Use of As-needed Medication|The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||inhalations/day||Standard Deviation|Mean
1451739|NCT00839800|Secondary|Forced Expiratory Volume in One Second (FEV1)|The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.|4, 12, 24, 36 and 52 weeks after randomization|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Liter (L)||Standard Deviation|Geometric Mean
1451740|NCT00839800|Secondary|Evening PEF|The mean value from a 52-week treatment period.|2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||L/min||Standard Deviation|Mean
1451741|NCT00839800|Secondary|Morning Peak Expiratory Flow (PEF)|The mean value from a 52-week treatment period.|52-week treatment period|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Liter/minute (L/min)||Standard Deviation|Mean
1451742|NCT00839800|Secondary|Number of Asthma Exacerbations|Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.|up to 52 weeks|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||Asthma exacerbations|||Number
1451743|NCT00839800|Primary|The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study|Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.|week 52|The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline.|||percentage of participants|||Number
1451744|NCT00839540|Primary|Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).~These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M)."|Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug|Each subject received drug and had serum samples drawn at pre-treatment, 1.5h, 12h, and 24h after dosing.|||Log inhibition|Participants||Number
1451745|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 104 and Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).|||Kilograms||Standard Deviation|Mean
1451746|NCT00839527|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
1451747|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) was assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
1451838|NCT00838981|Primary|Average Number of Positive Urine Tests|thrice weekly urine tests|up to 12 weeks.||||urine tests||Standard Deviation|Mean
1451748|NCT00839527|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who acheieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) was assessed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Participants|||Number
1451749|NCT00839527|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population|||Weeks||95% Confidence Interval|Median
1451750|NCT00839527|Secondary|Change From Baseline in FPG at Week 104 and Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1451751|NCT00839527|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1451752|NCT00839527|Secondary|Change From Baseline in HbA1c at Week 104 and Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline, Week 104, and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X, X in the category titles).|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1451753|NCT00839527|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. Nine par. with post-BL values obtained >14 days after the last dose or after hyperglycemic rescue were included in the analysis population but were not analyzed for this endpoint.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1451754|NCT00839436|Other Pre-specified|Change: CD4/CD8 T Cell Cts After CYT107; in Immunophenotype (Naive, Memory, Regulatory T Cell Subsets) & Amp; Antigen-specific T Cell Function After CYT107; in T Cell Activation/Proliferation Status & Amp; TCR Repertoire After CYT107; ...||48 weeks per patient with a 3-4 year enrollment period|||||||
1451755|NCT00839436|Primary|Adverse Events and Toxicities Associated With CYT107.||48 weeks per patient with a 3-4 year enrollment period||||Events|||Number
1451756|NCT00839423|Secondary|Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)||Week 6|FAS, LOCF|||percentage of patients|||Number
1451757|NCT00839423|Secondary|Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Week 6|FAS, LOCF|||percentage of patients|||Number
1451758|NCT00839423|Secondary|Change in Clinical Status Using CGI-I Score at Week 6|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
1451759|NCT00839423|Secondary|Change From Baseline in CGI-S Score After 6 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
1451760|NCT00839423|Secondary|Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
1451761|NCT00839423|Secondary|Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment|The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness). The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76. The higher the score, the more severe.|Baseline and Week 6|FAS, LOCF|||units on a scale||Standard Error|Mean
1451762|NCT00839423|Secondary|Change From Baseline in MADRS Total Score After 1 Week of Treatment||Baseline and Week 1|FAS, LOCF. Please note that 1 patient in each Vortioxetine group did not have a valid MADRS assessment at Week 1, but were included in the analysis because they had a valid MADRS assessment after Week 1.|||units on a scale||Standard Error|Mean
1451763|NCT00839423|Primary|Change From Baseline in MADRS Total Score After 6 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid baseline and one valid post-baseline assessment of the MADRS total score; Last Observation Carried Forward (LOCF)|||units on a scale||Standard Error|Mean
1451764|NCT00839332|Secondary|Phase 2: Electrocardiogram QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Twelve-lead ECG data was used to calculate QTc based on Fridericia's formula (QTc=QT/RR^0.33, where RR is the interval between two R waves). For each participant, changes in QTc were calculated by subtracting the reading taken before LY2603618 administration from the reading taken after LY2603618 administration on Days 2 and 16 during Cycle 1. The number of participants in which the change in QTc was <=30 milliseconds (msec), >30-60 msec, or >60 msec is presented.|Phase 2: Days 2 and 16 of Cycle 1|Phase 2 participants who received at least 1 dose of LY2603618 and had evaluable ECG data.|||Participants|||Count of Participants
1451765|NCT00839332|Secondary|Phase 1: Electrocardiogram QTc Prolongation|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Twelve-lead electrocardiogram (ECG) data was used to calculate the corrected QT (QTc) based on Fridericia's formula (QTc=QT/RR^0.33, where RR is the interval between two R waves). For each participant, changes in QTc were calculated by subtracting the reading taken before LY2603618 administration from the reading taken after LY2603618 administration on Days 2 and 16 during Cycle 1. The number of participants in which the change in QTc was <=30 milliseconds (msec), >30-60 msec, or >60 msec is presented by dose group and overall.|Phase 1: Days 2 and 16 of Cycle 1|Phase 1 participants who received at least 1 dose of LY2603618 and had evaluable ECG data.|||Participants|||Count of Participants
1451766|NCT00839332|Secondary|Phase 2: Duration of Response|Duration of response was defined as the time from the first observation of complete response (CR) or partial response (PR) to the first observation of progressive disease or death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date and who do not have progressive disease, the duration was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent anticancer therapy (systemic, radiologic, or surgery). Participants were also censored at the last valid assessment prior to missing more than 1 consecutive scheduled assessment. Duration of response was summarized using Kaplan-Meier estimates.|Phase 2. Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who received at least 1 dose of study drug and had a confirmed response (CR or PR).|||months||95% Confidence Interval|Median
1451767|NCT00839332|Other Pre-specified|Number of Deaths During the Phase 1 Post-study Period|The number of participants who died during the post-study period of Phase 1 does not include the outcomes for the 4 participants who died while on treatment during Phase 2 as captured in the Participant Flow Table. A summary of serious and other non‐serious adverse events regardless of causality is located in the Reported Adverse Events module.|Phase 1: Time of last dose of study drug through the end of the follow-up period|Participants enrolled in Phase 1.|||Participants|||Count of Participants
1451768|NCT00839332|Secondary|Phase 2: Clinical Benefit Rate|Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1 guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Overall response rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Phase 2: Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
1451769|NCT00839332|Secondary|Phase 2: Overall Response Rate|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Phase 2: Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
1451770|NCT00839332|Secondary|Phase 2: Progression-free Survival (PFS)|Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.|Phase 2: Baseline to measured progressive disease or date of death from any cause|Phase 2 participants who were randomized.|||months||95% Confidence Interval|Median
1451771|NCT00839332|Secondary|Phase 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618|Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma AUC(0-24), AUC(0-tlast), and AUC(0-inf) values are reported for the 230 mg LY2603618 dose on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point.|Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.|Phase 2 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable calculation of the LY2603618 AUC.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1451772|NCT00839332|Secondary|Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of Gemcitabine, dFdU, and LY2603618|Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine plasma and dFdU concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only LY2603618 plasma AUC from time zero to 24 hours (AUC[0-24]), AUC from time zero to the last time point with a measurable concentration (AUC[0-tlast]), and AUC from time zero to infinity (AUC[0-inf]) values are reported for each LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point.|Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.|Phase 1 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable calculation of the LY2603618 AUC.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1451773|NCT00839332|Secondary|Phase 2: Maximum Plasma Concentration (Cmax) of Gemcitabine, dFdU, and LY2603618|Plasma samples for PK analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported at the 230 mg LY2603618 dose level on Cycle 1 /Day 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each time point.|Phase 2: LY2603618 - Predose and 0, 1, 3, and 24 hours after the end of infusion on Days 2 and 16 of Cycle 1. Gemcitabine - Predose and 0, 10, 60, and 120 minutes after the end of infusion on Days 1 and 15 of Cycle 1.|Phase 2 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable determination of the LY2603618 Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1451774|NCT00839332|Secondary|Phase 1: Maximum Plasma Concentration (Cmax) of Gemcitabine, 2',2'-Difluorodeoxyuridine (dFdU), and LY2603618|Plasma samples for pharmacokinetic (PK) analysis were collected following IV infusion of each study drug. However, the dose-normalized PK analysis of gemcitabine and dFdU were not reported because the gemcitabine and dFdU plasma concentration data generated for all participants with PK samples collected in this study were withdrawn (invalidated) as a result of the failure of the Incurred Sample Reanalysis (ISR) for both gemcitabine and dFdU. Therefore, only the LY2603618 plasma Cmax values are reported for each LY2603618 dose level on Cycle (C) 1 /Day (D) 1, Cycle 1 /Day 16, and Cycle 2 /Day 2. The number of PK observations (n) used in the analysis is presented for each dose level and time point.|Phase 1: LY2603618 - Predose and 0, 1, 3, 6, 24, 48, and 72 hours after the end of infusion on C1 /D2, C1 /D16, and C2 /D2. Gemcitabine - Predose and 0, 10, 30, 60, and 120 minutes after the end of infusion on C1 /D1, C1 /D15, and C2 /D1.|Phase 1 participants who received at least 1 dose of study drug (LY2603618) and had sufficient LY2603618 plasma concentration data to enable determination of the LY2603618 Cmax.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1451775|NCT00839332|Primary|Phase 2: Overall Survival (OS)|Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the cut-off date. OS was summarized using Kaplan-Meier estimates.|Phase 2: Baseline to date of death|Phase 2 participants who were randomized.|||months||95% Confidence Interval|Median
1451776|NCT00839332|Primary|Phase 1: Determine the Recommended Phase 2 Dose for LY2603618 When Administered After Gemcitabine|The recommended Phase 2 dose for LY2603618 when administered approximately 24 hours after gemcitabine was based on the maximum tolerated dose and achievement of predefined LY2603618 plasma systemic exposures targets (area under the LY2603618 plasma concentration versus time curve from time zero to infinity [AUC(0-inf)] >21,000 nanogram*hour/milliliter [ng*h/mL] and maximum LY2603618 plasma concentration [Cmax] >2000 nanograms/milliliter [ng/mL]).|Baseline through 18 months|Phase 1 participants who received at least 1 dose of study drug.|||milligrams (mg)|||Number
1451777|NCT00839319|Primary|Intratesticular Testosterone (ITT-T)||10 days||||IU/L||Inter-Quartile Range|Median
1451778|NCT00839319|Primary|Serum Follicle Stimulating Hormone (FSH)||10 days||||IU/L||Inter-Quartile Range|Median
1451779|NCT00839319|Primary|Serum Luteinizing Hormone (LH)||10 days||||IU/L||Inter-Quartile Range|Median
1451780|NCT00839319|Primary|Serum Testosterone (T)||10 days|Analysis per protocol. Due to nonnormality, the data were expressed as medians and 25th and 75 percentiles. Analysis of both baseline and end of treatment hormone concentrations performed on 31 subjects who completed all study procedures and who suppressed serum LH below the lower limit of normal at end of treatment.|||nmol/liter||Inter-Quartile Range|Median
1451781|NCT00839306|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1451782|NCT00839306|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT|||Percentage of Participants|||Number
1451783|NCT00839241|Secondary|Lymphocytes||Day 8 postop||||percentage of white blood cells||Standard Deviation|Mean
1451784|NCT00839241|Secondary|Lymphocytes||Day 5 postop||||percentage of white blood cells||Standard Deviation|Mean
1451785|NCT00839241|Secondary|Lymphocytes||Day 1 postop||||percentage of white blood cells||Standard Deviation|Mean
1451786|NCT00839241|Secondary|Lymphocytes||Baseline||||percentage of white blood cells||Standard Deviation|Mean
1451787|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 8 postop||||10^3/uL||Standard Deviation|Mean
1451788|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 5 postop||||10^3/uL||Standard Deviation|Mean
1451789|NCT00839241|Secondary|Leucocyte Particle Concentration||Day 1 postop||||10^3/uL||Standard Deviation|Mean
1451790|NCT00839241|Secondary|Leucocyte Particle Concentration||Baseline||||10^3/uL||Standard Deviation|Mean
1451791|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 8 postop||||percentage of blood volume||Standard Deviation|Mean
1451792|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 5 postop||||percentage of blood volume||Standard Deviation|Mean
1451793|NCT00839241|Secondary|Erythrocyte Volume Fraction||Day 1 postop||||percentage of blood volume||Standard Deviation|Mean
1451794|NCT00839241|Secondary|Erythrocyte Volume Fraction||Baseline||||percentage of blood volume||Standard Deviation|Mean
1451795|NCT00839241|Secondary|Hemoglobin||Day 8 postop||||g/dL||Standard Deviation|Mean
1451796|NCT00839241|Secondary|Hemoglobin||Day 5 postop||||g/dL||Standard Deviation|Mean
1451797|NCT00839241|Secondary|Hemoglobin||Day 1 postop||||g/dL||Standard Deviation|Mean
1451798|NCT00839241|Secondary|Hemoglobin||Baseline||||g/dL||Standard Deviation|Mean
1451799|NCT00839241|Secondary|TNF-Alpha||Day 8 postop||||pg/mL||Standard Deviation|Mean
1451800|NCT00839241|Secondary|TNF-Alpha||Day 5 postop||||pg/mL||Standard Deviation|Mean
1451801|NCT00839241|Secondary|TNF-Alpha||Baseline||||pg/mL||Standard Deviation|Mean
1451802|NCT00839241|Secondary|Interleukin-10||Day 8 postop||||pg/mL||Standard Deviation|Mean
1451803|NCT00839241|Secondary|Interleukin-10||Day 5 postop||||pg/mL||Standard Deviation|Mean
1451804|NCT00839241|Secondary|Interleukin-10||Baseline||||pg/mL||Standard Deviation|Mean
1451805|NCT00839241|Secondary|Interleukin-6||Day 8 postop||||pg/mL||Standard Deviation|Mean
1451806|NCT00839241|Secondary|Interleukin-6||Day 5 postop||||pg/mL||Standard Deviation|Mean
1451807|NCT00839241|Secondary|Interleukin-6||Baseline||||pg/mL||Standard Deviation|Mean
1451808|NCT00839241|Secondary|Interleukin-4||Day 8 postop||||pg/mL||Standard Deviation|Mean
1451809|NCT00839241|Secondary|Interleukin-4||Day 5 postop||||pg/mL||Standard Deviation|Mean
1451810|NCT00839241|Secondary|Interleukin-4||Baseline||||pg/mL||Standard Deviation|Mean
1451811|NCT00839241|Secondary|Interleukin-2||Day 8 postop||||pg/mL||Standard Deviation|Mean
1451812|NCT00839241|Secondary|Interleukin-2||Day 5 postop||||pg/mL||Standard Deviation|Mean
1451813|NCT00839241|Secondary|Interleukin-2||Baseline||||pg/mL||Standard Deviation|Mean
1451814|NCT00839241|Secondary|Interferon Gamma||Day 8 postop||||pg/mL||Standard Deviation|Mean
1451815|NCT00839241|Secondary|Interferon Gamma||Day 5 postop||||pg/mL||Standard Deviation|Mean
1451816|NCT00839241|Secondary|Interferon Gamma||Baseline||||pg/mL||Standard Deviation|Mean
1451817|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 8 postop||||Percent||Standard Deviation|Mean
1451818|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Day 5 postop||||Percent||Standard Deviation|Mean
1451819|NCT00839241|Primary|Natural Killer Cells (Proportion of Lymphocytes, Measured With Flow Cytometry)||Baseline||||Percent||Standard Deviation|Mean
1451820|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 8 postop||||total number of cells * 10^5/mL||Standard Deviation|Mean
1451821|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Day 5 postop||||total number of cells * 10^5/mL||Standard Deviation|Mean
1451822|NCT00839241|Primary|Frequency of Natural Killer Cells as Measured With Flow Cytometry.||Baseline||||total number of cells * 10^5/mL||Standard Deviation|Mean
1451823|NCT00839098|Primary|Wheelchair Occupancy|Wheelchair occupancy was measured by the sum of duration that the seat of the wheelchair was occupied. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||hours||Standard Deviation|Mean
1451824|NCT00839098|Primary|Power Wheelchair Usage|Power wheelchair usage was measured by the sum of distances that the power wheelchair traveled (km) divided by the duration of the wheelchair being occupied a day (hr). The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||km/hour||Standard Deviation|Mean
1451825|NCT00839098|Primary|Frequency of Power Seat Function Usage|Frequency of power seat function usage was measured by the number of times of changing tilt and recline angles averaged by the duration that the participant occupied the wheelchair per day. The results of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||times/hour||Standard Deviation|Mean
1451826|NCT00839098|Secondary|Questionnaire Responses: Independence in Community|This outcome was measured in three aspects: Physical Independence, Cognitive Independence, and Mobility, using the three of the subscales of Craig Handicap Assessment and Reporting Technique Scale. The scores of each subscale has to be calculated with specific formula and weight based on the manual. The range of each subscale score are: Physical Independence: 28-100; Cognitive Independence: 15-100; and Mobility: 16-100. A higher score indicates greater independence. The analyzed results of the difference between the measurements at the end of 2nd week and 8th week were shown here.|At the end of 2nd (end of baseline) week and 8th week (end of intervention period) following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||units on a scale||Standard Deviation|Mean
1451827|NCT00839098|Secondary|Questionnaire Responses: Psychological Impacts of Assistive Devices Scale|This tool is to measure perceived psychological impact of using an assistive device. It consists of three subscales, Competence (12 items), Adaptability (6 items), and Self-esteem (8 items). Each item is scored on a likert scale from -3 (decreases) to + 3 (increases). The total score is the sum of all 26 items, ranging from -78 to 78. A higher positive score indicates more positive impact. A negative score indicates negative impact. The differences between the measurements taken at the end of 2nd week (end of baseline) and the end of 8th week (end of intervention period) are reported here to show the intervention effect.|At the end of every two weeks|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||units on a scale||Standard Deviation|Mean
1451828|NCT00839098|Secondary|Questionnaire Responses: Tool for Assessing Wheelchair Discomfort (TAWC)|General Discomfort Assessment (GD) and Discomfort Intensity Rating (DI) are two sub-scales of TAWC. Higher scores indicate greater discomfort. GD consists of 8 discomfort statements and 5 comfort statements. The statements are rated on a seven point Likert scale, from strongly disagree to strongly agree of points from 1-7 (total score: 13-91). DI includes seven body areas (back, neck, buttocks, legs, arms, feet, and hands) and overall discomfort level, rated for a degree of discomfort intensity on a scale of 0 (no discomfort) to 10 (severe discomfort). Space is also included for the user to list additional body areas. DI scores may range from 0 to more than 80, depending on whether the participant reported additional areas of discomfort. Although GD and DI were measured daily, the data were average for each two-week period. The average GD and DI of the difference between the baseline and week 7-8 (last 2 weeks) were shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair||||units on a scale||Standard Deviation|Mean
1451829|NCT00839098|Primary|Compliance Rate|Compliance rate is a measure of compliance with the recommendation of using powered seating functions (moderate or maximum range of tilt, at least once every hour, for 2 minutes). The participant had to follow the recommended position, duration, and frequency to be considered as compliant and performed successful repositioning exercise. The compliance rate of a participant was the number of successful repositioning exercise divided by the sum of the number of successful repositioning exercise and missed repositioning exercise. The result of the difference between the baseline and week 7-8 (last 2 weeks) was shown here.|Every 2 weeks for 8 weeks following acquisition of wheelchair|Only the data of the participants who completed the study protocol and use the wheelchair were included in the data analysis.|||Percentage of participants' compliance||Standard Deviation|Mean
1451830|NCT00839072|Secondary|Area Under the Concentration-time Curve From 0 to 24 Hours [AUC0-24]||24 hours|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng*h/mL||Standard Deviation|Mean
1451831|NCT00839072|Secondary|Apparent Terminal Elimination Half-Life [T½el]|The elimination half-life (T½el) of trazodone in plasma (time it takes for the concentration of trazodone to fall to half), expressed in hours.|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||Hours||Standard Deviation|Mean
1451832|NCT00839072|Secondary|Time of Maximum Measured Plasma Concentration (Tmax)||72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||hours||Full Range|Median
1451833|NCT00839072|Primary|Bioequivalence Based on AUC∞|AUC∞ = Area under the concentration-time curve extrapolated to infinity|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng*h/mL||Standard Deviation|Mean
1451834|NCT00839072|Primary|Bioequivalence Based on AUCT|AUCT = Area under the concentration-time curve from 0 to the time of the last quantifiable concentration|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng*h/mL||Standard Deviation|Mean
1451835|NCT00839072|Primary|Bioequivalence Based on Cmax|Cmax = Maximum plasma concentration Measured in nanograms per millilitre (ng/mL)|72 hours post-dose|The dataset for pharmacokinetic analysis comprised the 20 subjects who completed both study periods.|||ng/mL||Standard Deviation|Mean
1451836|NCT00838981|Secondary|Average Number of Days Using a Substance Within Treatment||up to 90 days||||days||Standard Deviation|Mean
1451837|NCT00838981|Primary|Average Maximum Days Abstinent||up to 84 days||||days||Standard Deviation|Mean
1451839|NCT00838929|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Vorinostat and Radiotherapy in Patients With Brain Metastases.|"To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Vorinostat and radiotherapy in patients with brain metastases.~The maximum tolerated dose (MTD) will be one dose below the DLT occurring in at least 1 out of 3 subjects.~Dose level -2: 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1: 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I: 200 mg PO qd (initial starting dose) Dose level II: 300 mg PO qd Dose level III: 400 mg PO qd"|Weekly during treatment On Last day of treatment (30 days after last drug dose) Follow-up (every 3 months)||||mg|||Number
1451840|NCT00838916|Secondary|Albiglutide Plasma Concentrations at Week 8 and Week 24|Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.|Weeks 8 and 24|ITT population. Only those participants with a PK sample available for analysis at the indicated time points were analyzed.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
1451841|NCT00838916|Secondary|Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52|A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.|Baseline and Week 52|Glucose Profile Substudy Population: all participants who participated in the 24-hour glucose profile substudy . Only those participants with a value at Baseline and Week 52 were analyzed.|||Millimoles per hour per liter (mmol.h/L)||Standard Deviation|Mean
1451842|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Kilograms||Standard Deviation|Mean
1451843|NCT00838916|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Kilograms||Standard Error|Least Squares Mean
1451844|NCT00838916|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
1451845|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Participants|||Number
1451846|NCT00838916|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 52|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Participants|||Number
1451847|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1451895|NCT00838279|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451848|NCT00838916|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1451849|NCT00838916|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1451850|NCT00838916|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide – insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 52|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1451851|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 156|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed.|||Kilograms||Standard Deviation|Mean
1451852|NCT00838903|Secondary|Change From Baseline in Body Weight at Week 104|The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.|||Kilograms||Standard Error|Least Squares Mean
1451853|NCT00838903|Secondary|Time to Hyperglycemia Rescue|Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in week|From the start of study medication until the end of the treatment (up to Week 156)|ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Weeks||95% Confidence Interval|Median
1451854|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.|Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Participants|||Number
1451855|NCT00838903|Secondary|Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104|The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.|Week 104|ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.|||Participants|||Number
1451856|NCT00838903|Secondary|Change From Baseline in FPG at Week 156|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.|Baseline and Week 156|ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1451857|NCT00838903|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104|The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 104.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1451858|NCT00838903|Secondary|Change From Baseline in HbA1c at Week 156|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed .|Baseline and Week 156|Intent-to-Treat (ITT) Population with observed values. Only those par. with a value at Baseline and at the specified visit were analyzed.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
1451859|NCT00838903|Primary|Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide – placebo, albiglutide – sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.|Baseline and Week 104|Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 104.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
1451860|NCT00838682|Other Pre-specified|Duration of Hospital Stay||6wk|intention to treat (ITT)|||days||Standard Deviation|Mean
1451861|NCT00838682|Other Pre-specified|Mean Units of Blood Transfusion|In order to compare the total amount of blood transfusion, mean units of blood transfusion was used.|day 3|intention to treat (ITT)|||Mean units of blood transfusion||Standard Deviation|Mean
1451862|NCT00838682|Secondary|Death||6wk|intention to treat (ITT)|||participants|||Number
1451863|NCT00838682|Secondary|Surgery|"This sencodary endpoint surgery is the operation for bleeding control of peptic ulcer bleeding such as gastric or duodenal primary closure, and subtotal gastrectomy with/without vagotomy."|6wk|intention to treat (ITT)|||participants|||Number
1451864|NCT00838682|Secondary|Rebleeding After 3 Days|Rebleeding after 3 days was assessed by checking the patients from day 3 to discharge and bleeding event or regular follow-up after discharge to week 6.|6wk|intention to treat (ITT)|||participants|||Number
1451865|NCT00838682|Primary|Rebleeding Within 3 Days||day 3|intention to treat (ITT)|||participants|||Number
1451866|NCT00838630|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451867|NCT00838630|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451868|NCT00838630|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 96 hour period|Data from subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451869|NCT00838578|Primary|Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0||Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months|ITT population|||participants|||Number
1451870|NCT00838539|Primary|Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Neratinib|Identification of the weekly temsirolimus high-dose MTD in combination with daily neratinib temsirolimus, and identification of the temsirolimus high-dose MTD in combination with Neratinib.|From first dose date to day 28|Evaluable subjects include those that either experienced a dose limiting toxicity within the first 28 days, regardless of the number of doses of treatment received, or those that received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment at the original dose level prescribed.|||mg|||Number
1451871|NCT00838539|Secondary|Area Under the Curve Tau|Area Under the Curve tau of neratinib concentrations, collected at 2, 4, 8, and 24 hours post-neratinib administration, at the week 4 dose.|Week 4|Subjects who had pharmacokinetic concentrations available at the dose combination, at day 22.|||ng*hr/mL||Full Range|Geometric Mean
1451881|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks Not specified.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through end of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451923|NCT00837967|Primary|Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||beats/min||Standard Deviation|Mean
1451872|NCT00838539|Secondary|Objective Response Rate|Percentage of subjects with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death or last tumor assessment, up to 30 months|Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (>= 21 doses of neratinib and >= 2 doses of Temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article[s])|||percentage of participants||95% Confidence Interval|Number
1451873|NCT00838539|Secondary|Clinical Benefit Rate|Percentage of subjects with a complete response, partial response, or stable disease >= 24 weeks, as determined by investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death or last tumor assessment, up to 30 months|Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (>= 21 doses of neratinib and >= 2 doses of temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article[s]).|||percentage of participants||95% Confidence Interval|Number
1451874|NCT00838539|Secondary|Best Overall Response|The best overall response and duration of response (for subjects who achieved an objective response) were described using the data as reported by study center investigators per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From first dose date to progression/death or last tumor assessment, up to 30 months|Subjects who completed at least 1 tumor assessment post-baseline after starting treatment and received sufficient drug (>= 21 doses of neratinib and >= 2 doses of temsirolimus in the first 28 days unless the subject discontinued treatment early for documented progression or symptomatic deterioration after taking at least 1 dose of test article[s])|||Participants|||Count of Participants
1451875|NCT00838539|Primary|Maximum Tolerated Dose (MTD) of Neratinib in Combination With Temsirolimus|Identification of the daily neratinib high-dose MTD in combination with weekly temsirolimus, and identification of the temsirolimus high-dose MTD in combination with Neratinib.|From first dose date to day 28|Evaluable subjects were those that either experienced a dose limiting toxicity within the first 28 days, regardless of the number of doses of treatment received, or those that received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment at the original dose level prescribed.|||mg|||Number
1451876|NCT00838539|Primary|Probability of Dose-Limiting Toxicity (DLT)|A DLT was defined as any dose-limiting Adverse Event related to neratinib + Temsirolimus as Grade 3 or higher nonhematologic toxicity (except neutropenia) or Grade 3 or higher diarrhea lasting >2 days with optimal antidiarrheal therapy etc.|From first dose date to day 28|Evaluable subjects for the Maximum Tolerated Dose (MTD) contour estimation were those who either experienced a DLT within the first 28 days, regardless of the number of doses of treatment received, or received at least 21 doses of neratinib and at least 2 doses of Temsirolimus in the first 28 days of treatment.|||percent probability|||Number
1451877|NCT00838526|Secondary|Secondary Outcome Measures Will Include: Adverse Events, Electrocardiograms (ECGs), Laboratory Evaluations (Hematology, Blood Chemistry, Urinalysis, and Gastrin), Gastric Biopsies, Physical Exam, and Vital Signs.|Information presented within Adverse Event information.|Baseline to Week 26|||||||
1451878|NCT00838526|Primary|Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26|"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference."|Baseline to Week 26|Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1451879|NCT00838526|Secondary|Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26|Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).|Baseline to Week 26|ITT|||Percentage of Participants|||Number
1451880|NCT00838513|Secondary|Pharmacokinetics (PK) and Pharmacodynamics (PD); Minimum and Maximum Blood Concentration||Induction Phase for 4 weeks followed by Maintenance Phase starting on Week 5 through 26 weeks or longer.|PK parameters Cmin and Cmax were estimated using a population PK model developed from the observed PK concentration data.|||micrograms/mil||Standard Deviation|Mean
1451882|NCT00838513|Secondary|Platelet Count Change From Baseline to 156 Weeks||From Baseline to 156 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1451883|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through end of study) for PE/PI and (from the fifteenth day following the first eculizumab dose through end of study) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through End of Study, Median Exposure 156 Weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
1451884|NCT00838513|Secondary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through end of study with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through end of study were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1451885|NCT00838513|Secondary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through End of Study, Median Exposure 156 Weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through end of study were performed for the ITT population. Exact 95% binomial confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451886|NCT00838513|Secondary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through End of Study, Median Exposure 156 Weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeksend of study were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451887|NCT00838513|Secondary|Percentage of Patients With Platelet Count Normalization|Platelet count normalization was defined as the platelet count observed to be ≥150 x 10^9/L on at least two consecutive measurements which span a period of at least four weeks|Through 26 Weeks|The tabulations of the proportion of patients who achieved platelet count normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451888|NCT00838513|Secondary|Platelet Count Change From Baseline to 26 Weeks||From Baseline to 26 Weeks|Change from baseline platelet counts were analyzed for the ITT population using a repeated measurement ANOVA model. A least squares (LS) mean for the change from baseline was produced for each study day for which a measurement of platelet count was scheduled. Significance of change was assessed at the 5% level at each time point.|||10^9 cells/L||95% Confidence Interval|Least Squares Mean
1451889|NCT00838513|Secondary|TMA Intervention Rate|TMA Intervention Rate (# PE/PI and # Dialysis Events/Patient/Day) in the eculizumab treatment period (from baseline through 26 weeks) for PE/PI and (from the fifteenth day following the first eculizumab dose through 26 weeks) for new dialysis events was compared with the TMA Intervention Rate during the pre-eculizumab treatment period.|Through 26 weeks|A signed rank test assessed differences in magnitudes of change in TMA intervention rate between the pre-eculizumab treatment period and during eculizumab treatment period for ITT population.|||#events/patient/day||Standard Deviation|Mean
1451890|NCT00838513|Primary|Percentage of Patients With Complete TMA Response|The proportion of patients who achieved a Complete TMA Response from baseline through 26 weeks of treatment with eculizumab was determined. Complete TMA Response was defined as Hematologic Normalization plus improvement in renal function (defined as (≥25% reduction from baseline in serum creatinine), which was sustained for two consecutive measurements over a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a complete TMA response from baseline through 26 weeks were performed. For this endpoint, for any relevant proportions, exact binomial 95% confidence intervals were produced.|||Percentage of Participants||95% Confidence Interval|Number
1451891|NCT00838513|Primary|Percentage of Patients With Hematologic Normalization|Hematologic Normalization was defined as normalization of both platelet count and lactic dehydrogenase (LDH) sustained for at least two consecutive measurements which spanned a period of at least four weeks.|Through 26 weeks|Tabulations of the proportion of patients who achieved a hematologic normalization through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451892|NCT00838513|Primary|Percentage of Patients With TMA Event-free Status|TMA Event-free status is defined as the absence for at least 12 weeks of [1] decrease in platelet count of > 25% from the Platelet Count Pre-PT Baseline Set Point; [2] PT while the patient is receiving eculizumab, and [3] new dialysis.|Through 26 weeks|The tabulations of the proportions of patients who achieved a TMA Event-Free status through 26 weeks were performed for the ITT population. Exact binomial 95% confidence intervals were produced for the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1451893|NCT00838331|Primary|The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow.|The primary outcome measures are changes in forearm blood flow (FBF) in recipients of fresh or stored RBC transfusions in response to acetylcholine. Secondary measures include changes in FBF with acetylcholine with or without L-NMMA, and changes in FBF with forearm exercise. In addition, flow mediated dilation (FMD) measurements will also be used to assess changes in brachial artery diameter before and after fresh vs aged RBC transfusions.|5 years||||mL / 100 mL / min||Standard Deviation|Mean
1451894|NCT00838279|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451896|NCT00838279|Primary|Cmax - Maximum Observed Concentration|Bioequivalence basd on Cmax|Blood samples collected over 120 hour period|Two subjects did not complete the study, and there was an issue with dosing of one subject (the whole tablet was not consumed for one of the periods) therefore there are 29 data sets that were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451897|NCT00838201|Primary|Overall Survival Through Month 24||24 months|Full Analysis Set|||Participants|||Number
1451898|NCT00838162|Secondary|Fluctuation Index of TMC310911|Fluctuation index, ie, percentage fluctuation: variation between maximum (Cmax) and minimum (Cmin) plasma concentration at steady-state, calculated as: 100 x ([Cmax-Cmin]/Css,av). Css,av is an average steady-state plasma concentration.|Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||Percent ng/mL||Standard Deviation|Mean
1451899|NCT00838162|Secondary|Average Steady-state Plasma Concentration (Css,av) of TMC310911||Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).|||ng/mL||Standard Deviation|Mean
1451900|NCT00838162|Secondary|Predose Plasma Concentration (C0h) of TMC310911||Day 2, Day 3, Day 4, Day 6, Day 8, Day 10, Day 12 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911).|||ng/mL||Standard Deviation|Mean
1451901|NCT00838162|Secondary|Area Under the Plasma Concentration-time Curve (AUC12) From the Time of Administration of TMC310911 up to 12 Hours After Dosing||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||ng.h/mL||Standard Deviation|Mean
1451902|NCT00838162|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||hours||Full Range|Median
1451903|NCT00838162|Secondary|Maximum Plasma Concentration (Cmax) of TMC310911||Day 1 and Day 14|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||ng/mL||Standard Deviation|Mean
1451904|NCT00838162|Secondary|Mean Changes From Baseline in CD4+ Cell Count||Baseline (Day 1), Day 8, Day 15|Intent-to-treat (ITT) Population - all randomized participants who received at least 1 dose of study medication (TMC310911)|||x 1000000 cells/L||Standard Error|Mean
1451905|NCT00838162|Secondary|Number of Participants With Virologic Response at Any Timepoint During the 14-day Treatment Period|Virologic response is a viral load test result below a chosen threshold value (less than 50 copies/mL, less than 400 copies/mL, or at least 1 log drop in viral load) at any timepoint during a 14-day treatment of 4 different dose regimens of TMC310911 coadministered with 100 mg ritonavir.|14 days|Intent-to-treat (ITT) Population- all randomized participants who received at least 1 dose of study medication (TMC310911)|||Participants|||Number
1451906|NCT00838162|Primary|Mean Changes From Baseline in Plasma log10 Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA)|The antiviral activity of TMC310911 is measured by the change in viral load from baseline in the 14 days of treatment following initiation of treatment with 4 different dosing regimens of TMC310911 coadministered with ritonavir.|Baseline (Day 1), Day 8, Day 15|Intent-to treat (ITT) population- participants who received at least 1 dose of study medication (TMC310911).|||log10 copies/mL||Standard Error|Mean
1451907|NCT00838136|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451908|NCT00838136|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451909|NCT00838136|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451910|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study.|||percentage of participants|||Number
1451911|NCT00838110|Primary|Percentage of Participants With Adverse Events (AEs) in Cohort 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study.|||percentage of participants|||Number
1451912|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
1451924|NCT00837967|Primary|Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||mmHg||Standard Deviation|Mean
1452139|NCT00836004|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1451913|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1|For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
1451914|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2|Abnormal ECG findings included maximum value of >=300 msec, maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval; maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
1451915|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1|Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia’s formula (QTcF interval).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
1451916|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2|Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.|Baseline up to Week 16 (follow-up)|Cohort 2 analysis set included all those participants in the SAS (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
1451917|NCT00838110|Primary|Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1|Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).|Baseline up to Week 30 (follow-up)|Cohort 1 analysis set included all those participants in the safety analysis set (SAS) (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.|||percentage of participants|||Number
1451918|NCT00838097|Secondary|Number of Participants With Non-serious Adverse Drug Reactions (ADRs)|"An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. A non-serious ADR was one in which none of the following applied:~Fatal~Life threatening~Required or prolonged in-patient hospitalization~A persistent or significant disability/incapacity, or~A congenital anomaly/birth defect."|2 years|Full analysis set|||participants|||Number
1451919|NCT00838097|Secondary|Parathyroid Hormone Level by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set|||pmol/L||Inter-Quartile Range|Median
1451920|NCT00838097|Secondary|Weight Adjusted Darbepoetin Alfa Monthly Dose by Monthly Intervals|Baseline dose = the daily dose equivalent x 30, where the daily dose equivalent = the last available dose prior to or at Day 1 / reported intended frequency.|Baseline and Months 1 to 24|Full analysis set|||μg/kg/month||95% Confidence Interval|Geometric Mean
1451921|NCT00838097|Secondary|Hemoglobin Concentration by Three Monthly Intervals||Baseline, Months 3, 6, 9, 12, 15, 18, 21, and 24|Full analysis set|||g/dL||95% Confidence Interval|Mean
1451922|NCT00838097|Primary|Number of Participants With Serious Adverse Drug Reactions (SADR), Serious Adverse Events (SAEs) or Events of Medical Interest (EMIs)|An ADR was defined as an undesirable medical occurrence or worsening of a pre-existing medical condition that the investigator considered associated with the use of darbepoetin alfa. An AE is any untoward medical occurrence or worsening of a pre-existing condition whether or not considered to have a causal relationship with darbepoetin alfa. An SADR or SAE is any ADR or AE that is either: • Fatal • Life threatening • Requires or prolongs in-patient hospitalization • A persistent or significant disability/incapacity, or • A congenital anomaly/birth defect. An EMI is defined as one of the following pre-specified AEs: Thromboembolic Events (eg, venous thrombosis, embolism, vascular occlusion) • Seizures • Severe hypertension (Investigator discretion accompanied by recorded blood pressure) • Cardiovascular events (eg, cardiac arrhythmia, myocardial ischaemia/infarction, heart failure) • Pure red cell aplasia (PRCA) • Hypersensitivity reactions (eg, rash, urticaria, anaphylaxis).|2 years|Full Analysis Set|||participants|||Number
1451925|NCT00837967|Primary|Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)|The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia’s formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||ms||Standard Deviation|Mean
1451926|NCT00837967|Primary|Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 140 min after start dosing for each treatment day||||mg/dLiters||Standard Deviation|Mean
1451927|NCT00837967|Primary|Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)|The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.|up to 740 min after start dosing for each treatment day||||mEq/L||Standard Deviation|Mean
1451928|NCT00837967|Primary|Adverse Events|Total number of adverse events|3 days||||adverse events|||Number
1451929|NCT00837876|Secondary|Number of Patients With Worst Grade Toxicities|Number of patients with worst-grade toxicity at each of five grades (grade 1 to 5, with 5 most severe) following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death.|every 4 weeks and every 8 weeks in follow-up to resolution of toxicity|All patients who received treatment with the study drugs. One patient did not receive treatment.|||participants|||Number
1451930|NCT00837876|Secondary|Number of Patients With Progression-free Survival|Participants with progression-free survival at 4 months.|at 4 months|Patients with progression-free survival at 4 months. The remaining 17 patients were not available for evaluation at 4 months due to toxicity (5), disease progression (5), patient withdrawal (1),respiratory failure (1), study drug held more than 28 days (1), and no study drug (1.|||participants|||Number
1451931|NCT00837876|Secondary|Response Rate|Per RECIST criteria v. 1.0: measurable lesions: CR disappearance of target lesions, PR > 30% decrease in the sum of the longest diameter (LD) of target lesions, PD > 20% increase in the sum of the LD of target lesions or appearance of new lesions, SD neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions|at 4 months|Participants who received treatment for 4 or more months. The remaining 10 participants received treatment for less than 4 months and were not evaluable.|||participants|||Number
1451932|NCT00837876|Primary|Number of Patients With Progression-free Survival|Number of patients with progression-free survival at 8 weeks|at 8 weeks|Patients who received treatment for >= 8 weeks. 14 study patients were treated for < 8 weeks due to toxicity (5), disease progression (5), did not receive study drug (1), respiratory failure (1), drug held more than 28 days (1), patient withdrawal (1). The remaining 13 participants did not have a progression-free survival at 8 weeks.|||participants|||Number
1451933|NCT00837824|Secondary|Plasma Globotriaosylceramide (GL-3)|This outcome measure evaluated the mean plasma GL-3 values for all patients to see if it decreased while on Fabrazyme. Normal plasma GL-3 level is defined as ≤ 7.03 µg/mL.|Evaluated at Baseline, Month 3, and Final Visit|"Fabrazyme 1mg/kg every 2 weeks: ITT population – 11 patients at baseline, 7 patients at Month 3, and 9 patients at Final Visit had Plasma GL-3 values.~Fabrazyme 3mg/kg every 2 weeks: ITT population - 9 patients at baseline, 2 patients at Month 3, and 7 patients at Final Visit had Plasma GL-3 values"|||µg/mL||Standard Deviation|Mean
1451934|NCT00837824|Primary|Time to Clinically Significant Progression of Cardiac Disease, Cerebrovascular Disease, and/or Death Among Fabry Patients With Severe Kidney Disease|The trial was terminated early due to inadequate study design. During the study period of 7 months, only 1 patient had a clinical event, a stroke, in the Fabrazyme 1 mg/kg treatment arm. The time to event was determined from first dose of Fabrazyme to the date of event.|7 months|Intent-to-Treat (ITT) Population-consisted of all 20 patients enrolled in the trial. The original sample size was 120 patients. Due to early termination, only 20 patients were enrolled in this trial. No imputation of data was performed. During the 7 months study period, only 1 patient had a clinical event in the Fabrazyme 1 mg/kg treatment arm.|||Days|||Number
1451935|NCT00837811|Secondary|Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)|The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported. Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer. The number of participants with baseline positive ADA data is also reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).|Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112)|Participants who received any amount of study drug.|||Participants|||Count of Participants
1451936|NCT00837811|Secondary|Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory. Higher scores indicated greater inflammation. Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in ESR indicated an improvement in the participant's condition.|Baseline, up to Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ESR assessment, excluding site with GCP issues; LOCF.|||percent change||Standard Deviation|Mean
1451982|NCT00837486|Other Pre-specified|Long-term Open-label Responders|This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders.|at the 24-month visit|29 participants started the the Long-Term Follow-up Phase and 24 completed the phase, but all 30 enrolled participants are included in the analysis. Participants that withdrew early are counted as non-responders.|||participants|||Number
1451937|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies|Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method. In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.|Baseline, up to Week 52|Participants who received any amount of study drug and had at least 1 post-baseline anti-CCP assessment, excluding site with GCP issues; LOCF.|||units per milliliter (U/mL)||Standard Deviation|Mean
1451938|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52|RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. A decrease in RF levels indicated an improvement in the participant's condition. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.|Baseline, Week 52|Participants who received any amount of study drug and had Week 52 post-baseline RF level assessment, excluding the site with GCP issues. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.|||international units/milliliter (IU/mL)||Standard Deviation|Mean
1451939|NCT00837811|Other Pre-specified|Number of Participants Who Died, Any Cause|A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)]. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early, the post-study treatment follow-up started immediately afterwards. After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).|Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 72 and start of Week 73 up to and through Week 112)|Participants who received any amount of study drug.|||Participants|||Count of Participants
1451940|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Serum Immunoglobulin|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in immunoglobulin levels.|Baseline, up to Week 52|Participants who received any amount of study drug and had at least 1 post-baseline serum immunoglobulin assessment; LOCF.|||grams per liter (g/L)||Standard Deviation|Mean
1451941|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)|Cell surface marker CD19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets. Cell surface markers were defined as being either present (+) or absent (-). Peripheral blood B cell subsets included: mature naive cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+). Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.|Baseline, Weeks 52, 60, 72, 80, 88, and 100|Participants who received any amount of study drug and had the specified peripheral blood B cell subset assessment post-baseline at the specified time points.|||cells/µL||Standard Deviation|Mean
1451942|NCT00837811|Secondary|Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts|B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928). A negative change indicated a decrease in cell count.|Baseline, Weeks 52, 60, 72, 80, 88, and 100|Participants who received any amount of study drug and a post-baseline total B cell assessment at the specified time points.|||cells per microliter (cells/µL)||Standard Deviation|Mean
1451943|NCT00837811|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores|SF-36 was a 36-item, health-related survey that assessed participant’s quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health). Domain scores calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status. The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100). The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100). Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline SF-36 assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
1451979|NCT00837577|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.|||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1451944|NCT00837811|Secondary|Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)|EULAR28 was defined by the participant’s change from baseline in DAS28 score and the absolute DAS28 score achieved. DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS). EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u). Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Percentage of participants=(number of participants with specific response/participants assessed)*100. Displayed percentages may not add up to 100% because of rounding.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline EULAR28 assessment; excludes site with GCP issues; LOCF.|||percentage of participants|||Number
1451945|NCT00837811|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)|The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS). The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square root(TJC28)+0.28*square root(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in DAS28 indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline DAS28 assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
1451946|NCT00837811|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score|The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items. Scores ranged from 0 to 52, where higher scores indicated less fatigue. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. An increase in FACIT fatigue score indicated an improvement of the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline FACIT assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
1451947|NCT00837811|Secondary|ACR-N Response|The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis. This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned. Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR-N assessment; excludes site with GCP issues; LOCF. No participant was analyzed in the 60/120/60 mg LY2127399 treatment arm.|||units on a scale||Standard Deviation|Mean
1451948|NCT00837811|Secondary|Percentage of Participants Achieving ACR70 Response|ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR70 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.|||percentage of participants|||Number
1451949|NCT00837811|Secondary|Percentage of Participants ACR50 Response|ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as NRI/LOCF. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR50 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.|||percentage of participants|||Number
1451980|NCT00837512|Primary|Onset Time (Tmax)|Average time to peak insulin concentration|0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours||||Minutes||Standard Deviation|Mean
1451950|NCT00837811|Secondary|Percentage of Participants Achieving ACR20 Response|ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. Participants who discontinued from study prior to Week 52 were imputed as non-responders. Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF. This composite data imputation was denoted as non-responder imputation (NRI)/LOCF. Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline ACR20 assessment; excludes site with GCP issues; missing data imputed by NRI/LOCF. Four (4), 29, and 1 participants were imputed as non-responders for the 60 mg, 60/120 mg, and 60/120/60 mg LY2127399 groups, respectively.|||percentage of participants|||Number
1451951|NCT00837811|Secondary|Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]|CRP is an indicator of inflammation. The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A negative change indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline CRP assessment; excludes site with GCP issues; LOCF.|||percent change||Standard Deviation|Mean
1451952|NCT00837811|Secondary|Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)|Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in joint pain indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of joint pain; excludes site with GCP issues; LOCF.|||mm||Standard Deviation|Mean
1451953|NCT00837811|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]|The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline HAQ-DI assessment; excludes site with GCP issues; LOCF.|||units on a scale||Standard Deviation|Mean
1451954|NCT00837811|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)|Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline physician's global assessment of disease activity; excludes site with GCP issues; LOCF.|||mm||Standard Deviation|Mean
1451955|NCT00837811|Secondary|Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)|Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in disease activity score indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline self-rated assessment of disease activity; excludes site with GCP issues; LOCF.|||mm||Standard Deviation|Mean
1451956|NCT00837811|Secondary|Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)|The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in swollen joint count indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline swollen joint assessment; excludes site with GCP issues; LOCF.|||swollen joints||Standard Deviation|Mean
1451981|NCT00837486|Other Pre-specified|Therapy-related Adverse Events|Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation.|from enrollment to study closure (average follow-up of 36 months)|All enrolled participants are included in the analysis.|||participants|||Number
1452140|NCT00836004|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1451957|NCT00837811|Secondary|Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]|The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study. A decrease in tender joint count indicated an improvement in the participant's condition.|Baseline, up to and through Week 52|Participants who received any amount of study drug and had at least 1 post-baseline tender joint assessment; excludes site with GCP issues; Last observation carried forward (LOCF).|||tender joints||Standard Deviation|Mean
1451958|NCT00837811|Primary|Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs|For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].|Baseline through Week 112|Participants who received any amount of study drug.|||Participants|||Count of Participants
1451959|NCT00837811|Primary|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early [early discontinuation (ED)], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study [which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)].|Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)|Participants who received any amount of study drug.|||Participants|||Count of Participants
1451960|NCT00837759|Secondary|Change in ZnT8 Autoantibody Titer||6 months following the protocol subject's randomization/treatment initiation||||Titers||Standard Error|Mean
1451961|NCT00837759|Secondary|Change in Anti-IA2 Titer||6 months following the protocol subject's randomization/treatment initiation||||Titers||Standard Error|Mean
1451962|NCT00837759|Secondary|Change in Anti-GAD Autoantibody Titers||6 months following the protocol subject's randomization/treatment initiation||||Titers||Standard Error|Mean
1451963|NCT00837759|Secondary|Change in Insulin Dose||6 months following the protocol subject's randomization/treatment initiation||||U/kg/day||Standard Deviation|Mean
1451964|NCT00837759|Secondary|Glycemia Control (Change in HbA1c Level)||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study|||Percentage||Standard Deviation|Mean
1451965|NCT00837759|Primary|Change in C-peptide||6 months following the protocol subject's randomization/treatment initiation|Only 3 subjects completed study|||ng/mL||Standard Deviation|Mean
1451966|NCT00837616|Secondary|Serum Estrone Sulfate Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||pg/mL||Standard Error|Mean
1451967|NCT00837616|Secondary|Serum Estrone Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||pg/mL||Standard Error|Mean
1451968|NCT00837616|Primary|Characterize PK/PD and Relative Biological Potency of Different Oral vs TD Estrogen Preparations||6 weeks|||||||
1451969|NCT00837616|Primary|Change in Fat Free Mass From Baseline at 12 Months||12 months||||kg||Standard Error|Mean
1451970|NCT00837616|Primary|Change in Percent Fat Mass From Baseline in 12 Months||12 months||||percent fat mass||Standard Error|Mean
1451971|NCT00837616|Primary|Change in Body Mass Index From Baseline at 12 Months||12 months||||kg/m2||Standard Error|Mean
1451972|NCT00837616|Secondary|Serum 17B Estradiol Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||pg/ml||Standard Error|Mean
1451973|NCT00837616|Secondary|Rates of Lipid Oxidation After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||Kcal/Fat Free Mass/day||Standard Error|Mean
1451974|NCT00837616|Secondary|Lipids Concentrations After Using Oral Versus Transdermal 17B Estradiol Replacement for 12 Months||12 months||||mg/dl||Standard Error|Mean
1451975|NCT00837616|Secondary|Changes in Insulin Growth Factor-I From Baseline at 12 Months||12 months||||ng/ml||Standard Error|Mean
1451976|NCT00837616|Primary|Change in Weight From Baseline at 12 Months||12 months||||kilograms||Standard Error|Mean
1451977|NCT00837577|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.|||mg/dL||95% Confidence Interval|Least Squares Mean
1451978|NCT00837577|Secondary|Change From Baseline in 2-hour Postprandial Glucose at Week 12|Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.|Baseline and Week 12|Full Analysis Set (FAS) defined as all randomized participants except those participants who did not provide written consent, who were found to be ineligible for the study, or have not taken any study drug during the study period.|||mg/dL||95% Confidence Interval|Least Squares Mean
1452225|NCT00835510|Secondary|Safety and Adverse Event Profile||42 days|||||||
1451983|NCT00837486|Secondary|Quality of Life Change|Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.|||change from baseline score||Standard Deviation|Mean
1451984|NCT00837486|Secondary|Depression Change|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change).|Baseline to 16 weeks|One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.|||percentage change from baseline||Standard Deviation|Mean
1451985|NCT00837486|Primary|Responders|Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response.|Baseline to 16 weeks|29 of the 30 subjects are included in this analysis. One active group subject did not receive the allocated treatment, and is not included in the primary and secondary efficacy outcome analyses.|||participants|||Number
1451986|NCT00837473|Secondary|Surgical Outcome- the Amount of Plexur™ P Product Utilized for Filling Void||During the time of operation, a range of 2.5-8.5 hrs||||cc||Standard Deviation|Mean
1451987|NCT00837473|Secondary|Surgical Outcome--length of Hospital Stay||From admission to discharge, a range of 2 to 20 days||||days||Standard Deviation|Mean
1451988|NCT00837473|Secondary|Surgical Outcome--blood Loss||During the time of operation, a range of 2.5-8.5 hrs||||ml||Standard Deviation|Mean
1451989|NCT00837473|Secondary|Surgical Outcome--operative Time||The time of operation, a range of 2.5-8.5 hrs||||min||Standard Deviation|Mean
1451990|NCT00837473|Secondary|Surgical outcome-the Amount of Cancellous Bone Harvested||During the time of operation, a range of 2.5-8.5 hrs||||cc||Standard Deviation|Mean
1451991|NCT00837473|Secondary|Surgical Related Outcome--locations of Iliac Crest Bone Harvest||During the time of operation, a range of 2.5-8.5 hrs||||Participants|||Count of Participants
1451992|NCT00837473|Secondary|Pain Status Assessed by Visual Analog Scale (VAS)|The visual analog scale (VAS) was used for assessing pain status in the body locations of back/neck, left leg/arm, and right arm/leg. Subjects were asked to rate their perception of pain in VAS, generated by the Osteotech Clinical Department. The scale from 1 to 5 represented the pain levels at none, mild, average, severe, and extreme.|Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||units on a scale||Standard Deviation|Mean
1451993|NCT00837473|Secondary|Oswestry Disability Index|The Oswestry Disability Index (ODI) is an internationally validated questionnaire consisting of ten sets of statements which focus on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and ability to travel. ODI scores are in a range of 0 to 100, with a lower score indicating less pain and disability and higher scores indicating more pain and disability.|Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||units on a scale||Standard Deviation|Mean
1451994|NCT00837473|Secondary|General Health Status|The general health status was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36v2). The SF-36v2 questionnaire contains 36 questions pertaining to eight subscales of health status. These eight subscales can be summarized as relating to either physical health or mental health. The physical component summary (PCS) is based primarily on the physical functioning, role-physical, bodily pain, and general health scales of the SF-36v2 survey. The mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 6 wks, 3 mths, 6 mths, 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||units on a scale||Standard Deviation|Mean
1451995|NCT00837473|Primary|Number of Participants With Reconstitution of Bone Growth in the Iliac Crest Bone Void Determined by an Independent Radiologist|"Reconstitution of bone growth was determined by an independent radiologist based on bony ingrowth and absence of a gap according to the following criteria:~Absent: limited or no bone mineralization visualized at the defect site; extensive areas of radiolucency.~Mild: identifiable bone mineralization and coalescence of the bone graft mass of < 50% of the defect site.~Moderate: identifiable bone mineralization and coalescence of the bone graft mass over > 50% of the defect site; some remaining unmineralized areas of radiolucency; limited evidence of partial bone remodeling and trabeculation.~Extensive: > 75% of bone mineralization over the defect site showing a contiguous and completely coalesced bone graft mass with confluent trabecular pattern."|6 wks, 3 mths, 6 mths 12 mths, and 24 mths|The primary analysis dataset included all study subjects with available data.|||Participants|||Count of Participants
1451996|NCT00837447|Primary|Change in Knee Society Knee Score|"change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome.~Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points"|baseline and 3 years||||scores on a scale||Standard Deviation|Mean
1451997|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.|||percentage of participants|||Number
1451998|NCT00837434|Secondary|Percentage of Participants Meeting ACR50 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.|||percentage of participants|||Number
1451999|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 24|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.|||percentage of participants|||Number
1452000|NCT00837434|Secondary|Percentage of Participants Meeting ACR20 Response Criteria at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP).~Participants with measurements for designated time points were included in the analysis."|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.|||percentage of participants|||Number
1452001|NCT00837434|Secondary|"Percentage of Participants Fulfilling DAS-28-CRP Good or Moderate Response Criteria at Week 24"|Good responders had: change in DAS28-CRP (Baseline-Week 24) > 1.2 and the Week 24 DAS-CRP score was <= 3.2. If the conditions for non-response* or good response were not met then the DAS28-CRP response was considered moderate.[*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline –Week 24) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 24) < 1.2 with Week 24 DAS28-CRP score > 5.1 ; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. Participants with measurements for designated time points were included in the analysis.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.|||percentage of participants|||Number
1452002|NCT00837434|Secondary|Percentage of Participants Fulfilling DAS-28-CRP “Good or Moderate Response” Criteria at Week 12|Good responders: change in DAS28-CRP (Baseline-Week12) > 1.2 and Week 12 DAS-CRP score was <\= 3.2. If the conditions for non-response* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. [*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline –Week 12) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 12) < 1.2 with Week 12 DAS28-CRP score > 5.1; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <\= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point].|Week 12|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.|||percentage of participants|||Number
1452003|NCT00837434|Primary|Percentage of CD27+ Switched Memory B Cells at Week 12|Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling.|Week 12|The Per Protocol population includes subjects with a baseline and week 12 (plus or minus 1 week) assessment that received at least 75% of the planned doses of either etanercept or adalimumab prior to week 12 and who did not have any serious protocol deviations.|||Percentage of B Cells||Standard Deviation|Mean
1452004|NCT00837330|Primary|Commonly Reported and Notable Adverse Events|Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.|2 years||||participants|||Number
1452005|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 6 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in micrograms.|6 Months||||µg||Standard Deviation|Mean
1452006|NCT00837252|Secondary|Change in Urinary Cortisol Level at Month 3 Compared to Baseline|The amount of cortisol found in urine was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in micrograms.|3 Months||||µg||Standard Deviation|Mean
1452007|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 6 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in nanograms of testosterone per decaliter of serum.|6 Months||||ng/dL||Standard Deviation|Mean
1452008|NCT00837252|Secondary|Change in Serum Testosterone Level at Month 3 Compared to Baseline|The concentration of testosterone in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in nanograms of testosterone per decaliter of serum.|3 Months||||ng/dL||Standard Deviation|Mean
1452009|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 6 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 6. The mean change from baseline to Month 6 is reported here in picograms of DHT per milliliter of serum.|6 Months|Only the 3 patients who were rechallenged with finasteride after Month 3 were included in this analysis.|||pg/mL||Standard Deviation|Mean
1452010|NCT00837252|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The concentration of dihydrotestosterone (DHT) in blood serum was assessed from each participant at baseline and at Month 3. The mean change from baseline to Month 3 is reported here in picograms of DHT per milliliter of serum.|3 Months||||pg/mL||Standard Deviation|Mean
1452011|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 6 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|6 Months||||µL||Standard Deviation|Mean
1452012|NCT00837252|Secondary|Change in Subretinal Fluid Volume at Month 3 Compared to Baseline|"Subretinal fluid volume was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the Edit Segmentation function of the Cirrus HD-OCT software. In cases where a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of subretinal fluid volume."|3 Months||||µL||Standard Deviation|Mean
1452013|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 6 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months||||µm||Standard Deviation|Mean
1452014|NCT00837252|Secondary|Change in Center-Subfield Macular Thickness at Month 3 Compared to Baseline|Central-subfield macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|3 months||||µm||Standard Deviation|Mean
1452015|NCT00837252|Secondary|Change in Visual Acuity at Month 6 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months||||ETDRS letters||Standard Deviation|Mean
1452016|NCT00837252|Primary|Change in Visual Acuity at Month 3 Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|3 months||||ETDRS letters||Standard Deviation|Mean
1452017|NCT00837213|Secondary|Percentage of Particpants With IGA Score at Week 16|"Investigator Global Assessment (IGA) at Week 16 based on the Investigator Global Assessment~IGA:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe"|Baseline, Week 16|Subjects who completed week 16|||Percent of participants|||Number
1452018|NCT00837213|Primary|Change in Investigator Global Assessment (IGA)|"Change in Investigator Global Assessment (IGA) Average values chest and back.~IGA scale:~0 - Clear~0.5 - Clear/almost clear~Almost Clear~1.5- Almost Clear/Mild~Mild~2.5- Mild/Moderate~Moderate~3.5- Moderate/Severe"|Baseline, Weeks 4, 8,12, and 16|ITT|||Units on a scale||Standard Deviation|Mean
1452019|NCT00837213|Secondary|Percent Change in Total Lesions (Chest and Back) From Baseline to Week 12|Percent change in total lesions (chest and back) from baseline to Week 12|Week 12|ITT|||Percent change||Standard Deviation|Mean
1452020|NCT00837213|Secondary|Percent Change in Non-inflammatory Lesions (Chest and Back) From Baseline to Week 12|Percent change in non-inflammatory lesions (chest and back) from baseline to Week 12|Baseline, Week 12|ITT|||Percent change||Standard Deviation|Mean
1452021|NCT00837213|Secondary|Percent (%) Change in Inflammatory Lesion Counts (Chest and Back) From Baseline to Week 12|Percent change in inflammatory lesion counts (chest and back)from Baseline to Week 12|Baseline, Week 12|ITT|||Percent Change||Standard Deviation|Mean
1452022|NCT00837213|Primary|Percent Change in Total Acne Lesion Counts From Baseline to Week 16|Percent change from baseline to week 16 in total acne lesions (inflammatory + non-inflammatory)|Baseline, Week 16|ITT|||Percent Change||Standard Deviation|Mean
1452023|NCT00837213|Primary|Percent (%) Change in Non-inflammatory Acne Lesions From Baseline to Week 16.|Percent change in Non-inflammatory acne lesions (whiteheads and blackheads)(chest and back) from baseline to week 16.|Baseline, Week 16|ITT|||Percent Change||Standard Deviation|Mean
1452024|NCT00837213|Primary|Percent Change in Inflammatory Acne Lesions From Baseline to Week 16|Percent change from baseline to week 16 in inflammatory acne lesions (pustules/papules)(chest and back)|Baseline, Week 16|ITT|||Percent change||Standard Deviation|Mean
1452025|NCT00837200|Primary|Study Specific Measure (Number of Participants Taken Off Study)||16 weeks||||participants|||Number
1452026|NCT00837200|Primary|Study Specific Measure (Response)||16 Weeks||||participants|||Number
1452041|NCT00836927|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who discontinued study drug due to an adverse event is presented.|Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Participants|||Count of Participants
1452027|NCT00837200|Primary|Tumor Response|"Leukemias mainly w/peripheral blood counts/diff every 2 wks/CLL, CT scan before initiation of study, 2nd CT after EOT, no CT at FU~Lymphomas restaged w/CT scans of chest/abdomen/pelvis or PET/CT scans after 2 cycles~MM monitored w/tumor markers monthly Quantitative immunoglobulins/SPEP w/quantitative M component in MM pts producing full antibody, UPEP w/ quantitative Bence-Jones in MM pts producing only light chains/Serum free light chains obtained all pts/Skeletal surveys at baseline Tumor responses:CR complete resolution of all detectable clinical/radiographic evidence of disease, disappearance of all disease related symptoms, and normalization of biochemical abnormalities for at least 6 wks following treatment and no BM infiltration;PR reduction of all measurable lesions by 50% or more/no new lesions;SD not fulfilling PR criteria/no evidence disease progression;PD increase original tumor mass by more than 25% lesion/new lesion~Stable disease > 2mo was a response"|16 weeks||||participants|||Number
1452028|NCT00837161|Secondary|Discomfort Level|Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.~Analysed subject numbers were:~from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"|||units on a scale||Full Range|Mean
1452029|NCT00837161|Secondary|Numerical Range Scale (NRS) of Pain Level|Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.|Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks|"Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.~Analysed subject numbers were:~from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;"|||units on a scale||Full Range|Mean
1452030|NCT00837161|Secondary|Length of Time to Return to Normal Activities|Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)]|per protocol|||days||Full Range|Mean
1452031|NCT00837161|Secondary|HIFU Treatment Equals Location Per Hysterectomy|Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.|Day 0, Hysterectomy|All participants who underwent hysterectomy following MR-HIFU treatment were included in this endpoint measure. Patients who refused hysterectomy were not included.|||participants|||Number
1452032|NCT00837161|Primary|Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids|The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.|end of follow-up (date of hysterectomy, at latest day 30 after treatment)|Safety was assessed per protocol; all 11 participants were evaluated for adverse events after HIFU treatment.|||treatment-related AE/patient||Full Range|Mean
1452033|NCT00837148|Primary|Overall Objective Response|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)|at 18 weeks||||participants|||Number
1452034|NCT00837031|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|Length of time, in months, that patients were alive from their first date of protocol treatment until death|18 months||||months||95% Confidence Interval|Median
1452035|NCT00837031|Secondary|Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease|The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease|18 months||||months||95% Confidence Interval|Median
1452036|NCT00837031|Primary|Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment|The percentage of patients who were alive 6 months after beginning treatment|6 months||||percentage of participants||95% Confidence Interval|Number
1452037|NCT00836953|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Reciprocal Hemagglutination Inhibition Titers (Seroconversion)|Seroconversion defined as the percentage of participants with ≥ 4-fold increases in reciprocal hemagglutination inhibition titer from pre- to post-vaccination.|Day 0 and Day 14 Post-dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.|||Percentage of Participants|||Number
1452038|NCT00836953|Other Pre-specified|Percentage of Participants With Pre- and Post-Vaccination Reciprocal Hemagglutination Inhibition Titers ≥ 40 (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 pre- and post-vaccination.|Day 0 and Day 14 after Dose 2|Immunogenicity analysis was on all enrolled and vaccinated subjects with adequate sera for testing, per-protocol population.|||Percentage of Participants|||Number
1452039|NCT00836953|Primary|Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination|Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.|Day 0 to 3 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population|||Participants|||Number
1452040|NCT00836927|Secondary|Duration of Response (DOR)|For participants who demonstrated a confirmed response (Completed Response [CR] or Partial Response [PR]) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment.|Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment and who experienced a CR or PR.|||Days|||Number
1452120|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Basal Cell Carcinoma Versus Control Group||baseline||||Raman spectrocopy intensity counts||Standard Deviation|Mean
1452042|NCT00836927|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up.|Up to approximately 2991 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Days||Full Range|Mean
1452043|NCT00836927|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first documented progressive disease (PD), or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS for all participants is presented in days.|Up to approximately 2961 days (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Days||Full Range|Mean
1452044|NCT00836927|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a participant during a clinical study or the follow-up period, regardless of relationship to study drug. The number of participants who experienced an adverse event is presented.|Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017)|All participants who received any study drug on this extension protocol according to their actual treatment.|||Participants|||Count of Participants
1452045|NCT00836901|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
1452046|NCT00836901|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
1452047|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng/mL||Standard Deviation|Mean
1452048|NCT00836901|Primary|AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
1452049|NCT00836901|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452050|NCT00836901|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452051|NCT00836875|Secondary|Time to Death||Baseline up to 1 month post treatment|Safety population; only participants who died were included in the analysis.|||days||Full Range|Median
1452052|NCT00836875|Secondary|Attributable Mortality - Number of Participant Deaths|Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).|Weeks 6 and EOT (up to Week 12)|Safety population|||participants|||Number
1452053|NCT00836875|Secondary|All-Cause Mortality - Number of Participant Deaths|Number of participant deaths reported at Week 6 and at EOT (up to Week 12).|Week 6 and EOT (up to Week 12)|Safety population|||participants|||Number
1452054|NCT00836875|Secondary|Percentage of Participants With a Global Response of Success|Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to <90% resolution of the radiological lesions attributed to IA at Baseline.|Weeks 6 and End of Treatment (EOT; up to Week 12)|Modified intent to treat (MITT) population: all participants receiving at least 1 dose of study drug and diagnosed with proven or probable aspergillosis (defined by modified European Organization for Research and Treatment of Cancer Mycoses Study Group [EORTC/MSC] criteria) or microbiologically confirmed scedosporium or fusarium infection.|||percentage of participants||95% Confidence Interval|Number
1452055|NCT00836875|Primary|Number of Participants With Adverse Events (AEs)||Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment|Safety population|||participants|||Number
1452056|NCT00836810|Secondary|Clinician's Opinion of Disease Activity.|100mm visual analogue scale. Question: Clinician's opinion of disease activity. Anchors: None; Severe Min 0 Max 100 (worse)|Current at baseline and after 2 weeks treatment||||mm||Standard Deviation|Mean
1452057|NCT00836810|Secondary|Patient's Opinion of Condition|100mm visual analogue scale. Question: Considering all the ways your pain and/or stiffness affect(s) you, please mark on the line how well you are doing. Anchors: Very well; Very badly. Min 0 Max 100 (poor outcome).|Current value at baseline and after 2 weeks treatment||||mm||Standard Deviation|Mean
1452058|NCT00836810|Secondary|Pain (Severity)|100mm visual analogue scale. Question: How much pain have you had in the last 24 hours? Anchors: No pain; Severe pain. Min score 0, Max score 100. Higher value is worse outcome.|24 hour period after 2 weeks of treatment||||mm||Standard Deviation|Mean
1452059|NCT00836810|Secondary|Percentage Change in Morning Stiffness|How long was your morning stiffness today? Pre-treatment (Night A) value minus post-treatment (Night B) value divided by pre-treatment value.|2 weeks||||percentage of baseline morning stiffness||Standard Deviation|Mean
1452060|NCT00836810|Primary|Change in Area Under the Curve (AUC) of Plasma IL-6|Pre-treatment (Night A) AUC minus post-treatment (Night B) AUC. AUC calculated from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B).|24 hour measurements 2 weeks apart||||pg*hr/ml||Standard Deviation|Mean
1452061|NCT00836810|Primary|Change in Peak Serum IL-6 Concentration|Pre-treatment (Night A) peak minus post-treatment (Night B) peak. Peaks defined as the highest value for each patient from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B) and the peak identified for each one.|24 hours||||pg/ml||Standard Deviation|Mean
1452062|NCT00836745|Secondary|Number of Participants Who Required Management of Other Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.|||participants|||Number
1452063|NCT00836745|Secondary|Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events|An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.|Baseline up to 1 year from start of first dose|Safety analysis set included all enrolled participants who started treatment with sunitinib.|||participants|||Number
1452064|NCT00836745|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)|Per protocol (PP) analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started sunitinib treatment.|||percentage of participants||95% Confidence Interval|Number
1452065|NCT00836745|Primary|Progression Free Survival (PFS)|PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.|Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)|Data was not analyzed since PFS for all participants was censored either due to inadequate baseline assessments, absence of on-study disease assessment, or being on follow-up for progression.||||||
1452066|NCT00836719|Secondary|Change in Brain NAA Level as Measured by MR Spectroscopy|percent change from baseline to exit in NAA levels adjusted for creatine levels|6 months||||percentage change from baseline||95% Confidence Interval|Mean
1452067|NCT00836719|Primary|Number of Participants Experiencing Serious Adverse Events||six months||||participants|||Number
1452068|NCT00836706|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452069|NCT00836706|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452070|NCT00836706|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452071|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint|GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||participants|||Number
1452072|NCT00836693|Secondary|Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint|GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||participants|||Number
1452073|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percentage of yes responses||Standard Deviation|Mean
1452074|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percentage of yes responses||Standard Deviation|Mean
1452121|NCT00836342|Secondary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Subjects With History of Basal Cell Carcinoma||baseline||||Raman spectroscopy intensity counts||Standard Deviation|Mean
1452075|NCT00836693|Secondary|"Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses"|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. Were you able to achieve at least some erection (some enlargement of the penis)?  Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percentage of yes responses||Standard Deviation|Mean
1452076|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
1452077|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
1452078|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
1452079|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
1452080|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire|SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
1452081|NCT00836693|Secondary|The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint|The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).|Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||units on a scale||Standard Deviation|Mean
1452082|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary|The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.|Baseline, 12 weeks|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percent||Standard Deviation|Mean
1452083|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||percent of volumetric change||Standard Deviation|Mean
1452084|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||minutes||Standard Deviation|Mean
1452085|NCT00836693|Secondary|Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night|NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.|Baseline, Week 12|The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.|||Number of events per night||Standard Deviation|Mean
1452086|NCT00836693|Primary|Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per participant."|Baseline, 12 weeks|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.|||percentage of yes responses||Standard Deviation|Mean
1452087|NCT00836693|Primary|Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per participant."|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.|||percentage of yes responses||Standard Deviation|Mean
1452088|NCT00836693|Primary|Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|Baseline, Week 12|The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.|||units on a scale||Standard Deviation|Mean
1452089|NCT00836641|Secondary|Number of Vaccinees With Adverse Events|we evaluated the safety and tolerability of sequential pneumococcal immunization as to local and systemic adverse events.|12 months||||participants|||Number
1452090|NCT00836641|Primary|Immunogenicity of Pneumococcal Vaccination|we performed pneumococcal serotype specific ELISA according to WHO's criteria for protective threshold values (>0.35 µg/ml).|12 months|we performed a power calculation in advance. To demonstrate a difference wit p<0.05, we would require 30 subjects per arm each. Thus and to allow potential drop-outs, we included 35 subjects per arm.|||[µg/ml]||95% Confidence Interval|Geometric Mean
1452091|NCT00836498|Secondary|Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3|||||||
1452092|NCT00836498|Secondary|Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3|||||||
1452093|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
1452094|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
1452095|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
1452096|NCT00836498|Primary|Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3|||||||
1452097|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
1452098|NCT00836498|Secondary|Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1||Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
1452099|NCT00836498|Primary|Part II: Number of Participants With Serious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 180 days following the third dose of RotaTeq™ and/or placebo|||||||
1452100|NCT00836498|Primary|Part II: Number of Participants With Nonserious Adverse Experiences|Part II was not conducted due to study termination; this report summarizes study results from Part I only.|Up to 42 days following any dose of RotaTeq™ and/or placebo|||||||
1452101|NCT00836498|Primary|Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)|GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo.|Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo|"All endpoints exclude protocol violators & participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window & were not protocol violators."|||titers||95% Confidence Interval|Geometric Mean
1452102|NCT00836498|Primary|Part I: Number of Participants With Serious Adverse Experiences (SAEs)|"All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.~SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose."|Up to 180 days following the third dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience."|||participants|||Number
1452103|NCT00836498|Primary|Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)|All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.|Up to 42 days following any dose of RotaTeq™ or placebo|"All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience."|||participants|||Number
1452104|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452105|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452106|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452107|NCT00836472|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452108|NCT00836472|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452109|NCT00836472|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452110|NCT00836433|Secondary|Change in Facility Fall Rates|Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).|6 months|"This is a facility level analysis of the fall rates in the 4 facilities randomized to FALLS alone compared to the 4 receiving CONNECT + FALLS. Within these groups, medical records from 293 and 358 residents with falls were abstracted to calculate the fall rates, therefore the number of participants analyzed is not the same as the flow module."|||change in falls per bed per year|Participants||Number
1452111|NCT00836433|Primary|Fall-related Process Measures|The proportion of applicable fall quality indicators documented for residents with falls during the study period. Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.|6 months|Note that the number of participants analyzed is not the same as the number of participants in the flow module. This is because this outcome measure is based not on the consented staff participants in the intervention, but resident charts abstracted in the pre and post intervention periods (waiver of consent obtained).|||proportion of indicators completed||Standard Deviation|Mean
1452112|NCT00836407|Secondary|To Measure Tumor Marker Kinetics (CA 19-9) in Patients Receiving Treatment.||4 years|||||||
1452113|NCT00836407|Secondary|To Explore an Association Between Immune-related Adverse Events (IRAEs) and ORR.||4 years|||||||
1452114|NCT00836407|Secondary|To Estimate Overall Response Rate (ORR), Immune Related Best Overall Response Rate (irBOR), Progression Free Survival (PFS), and Duration of Response in Patients Receiving Treatment.||4 years|||||||
1452115|NCT00836407|Secondary|Overall Survival (OS)||4 years||||Months||95% Confidence Interval|Median
1452116|NCT00836407|Primary|Determine if Ipilimumab Alone or in Combination With Pancreatic Tumor Vaccine Has an Acceptable Safety Profile (Less Than 33% Unacceptable Toxicity) in Subjects With Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma|Unnacceptable toxicities are defined as drug related > grade 4 AEs or grade 3 AE including IRAEs not improving to < grade 2 under therapy within 2 weeks. In addition, > grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to < grade 1 severity within 2 weeks of starting therapy, or requires systemic therapy is an unacceptable toxicity.|4 years||||Percent|||Number
1452117|NCT00836355|Secondary|Modified Rankin Scale Score||Baseline, and approximately one week and 3 months later|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.||||||
1452118|NCT00836355|Secondary|NIH Stroke Scale Scores||Baseline and after approximately one week|This trial was terminated early because of logistical challenges in data collection. No outcome measures data was able to be collected.||||||
1452119|NCT00836355|Primary|Indices of Salvaged Ischemic Penumbra and of Final Infarct Volume Based on Quantitative Volumetric Analyses of Pre- and Post-treatment Perfusion-weighted and Diffusion-weighted Brain MR Imaging||Within approximately 7 days of stroke onset|Although all participants completed the study, none of them had the necessary MRIs performed to gather outcome measure data. The study was closed once it was determined that logistically, it was not possible to complete the study at that point in time.||||||
1452122|NCT00836342|Primary|Skin Carotenoid Levels in Subjects With History of Squamous Cell Carcinoma Versus Control Subjects|Mean carotenoid levels in subjects with a history of squamous cell carcinoma were compared to mean carotenoid levels in control subjects without a history of nonmelanoma skin cancer.|baseline|Participants that passed inclusion criteria and consented for skin carotenoid measurement were analyzed.|||Raman spectroscopy intensity counts||Standard Deviation|Mean
1452123|NCT00836277|Secondary|1-year (Overall) Survival Rate||1 year||||percentage of participants|||Number
1452124|NCT00836277|Secondary|Overall Survival (OS)||Up to 45 months (cohort)||||months||95% Confidence Interval|Median
1452125|NCT00836277|Secondary|Progression-free Survival (PFS)|Survival time the is free of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 45 months (cohort)||||months||95% Confidence Interval|Median
1452126|NCT00836277|Primary|Clinical Benefit Rate (CBR)|Using RECIST v1.0 criteria, clinical benefit rate (CBR) = # participants with (PR) + # participants with (CR) + # participants with (SD) / # participants with (PR) + # participants with (CR) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions is defined as: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 14 months||||percentage of participants||95% Confidence Interval|Number
1452127|NCT00836277|Primary|Response Rate (RR)|Response rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started|Up to 14 months||||percentage of participants||95% Confidence Interval|Number
1452128|NCT00836095|Secondary|Insertion Success Rate|Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.|During intubation of the patient||||Number of successful airway insertions|||Number
1452129|NCT00836095|Primary|Insertion Time|The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.|During intubation of the patient||||seconds||Standard Deviation|Mean
1452130|NCT00836056|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452131|NCT00836056|Primary|Bioequivalence Based on AUCinf|AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452132|NCT00836056|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452133|NCT00836017|Secondary|Pain Numeric Rating Scale Score|Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.|||score on a scale||Standard Deviation|Mean
1452134|NCT00836017|Secondary|Percentage of Participants With Improvement in the Patient Global Impression of Change|The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|Participants with data available for this outcome measure at all visits.|||percentage of participants|||Number
1452135|NCT00836017|Secondary|Percentage of Participants With Improvement in Clinicians Global Impression of Change|The physician evaluated the change in the patient’s present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.|||percentage of participants|||Number
1452136|NCT00836017|Secondary|Percentage of Participants With Cervical Dystonia (CD) Severity Mild|The physician assessed the patient’s severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported.|Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.|||percentage of participants|||Number
1452137|NCT00836017|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score|TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.|4-6 weeks after treatment 3 (Up to 104.3 weeks)|All participants with data available for this outcome measure at all visits.|||score on a scale||Standard Deviation|Mean
1452141|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452142|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452143|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Metformin|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452144|NCT00835991|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glyburide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452145|NCT00835991|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glyburide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452146|NCT00835991|Primary|Cmax (Maximum Observed Concentration) - Glyburide|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452147|NCT00835978|Secondary|PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.|||Months||95% Confidence Interval|Median
1452148|NCT00835978|Secondary|ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms|ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of participants||95% Confidence Interval|Number
1452149|NCT00835978|Secondary|Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Ratio||Standard Deviation|Mean
1452150|NCT00835978|Secondary|Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
1452151|NCT00835978|Secondary|Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Ratio||Standard Deviation|Mean
1452152|NCT00835978|Secondary|Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline|CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.|At baseline - Beginning of the lead-in period (Cycle 1 Day 1)|The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.|||Fluorescent Intensity Unit (FIU)||Standard Deviation|Mean
1452153|NCT00835978|Secondary|Change From Baseline in Diastolic Blood Pressure|Value at respective visit minus value at baseline.|At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.|The SA population consists of all participatns who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1452154|NCT00835978|Secondary|Change From Baseline in Systolic Blood Pressure|Value at respective visit minus value at baseline|At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.|The SA population consists of all participatns who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1452155|NCT00835978|Secondary|Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||L||95% Confidence Interval|Geometric Mean
1452156|NCT00835978|Secondary|Apparent Oral Clearance (CL/F) of Axitinib|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||L/hr||95% Confidence Interval|Geometric Mean
1452157|NCT00835978|Secondary|Plasma Decay Half-Life (t1/2) for Axitinib|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hr||Standard Deviation|Mean
1452158|NCT00835978|Secondary|Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib|Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||ng.hr/mL||95% Confidence Interval|Geometric Mean
1452159|NCT00835978|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib|Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||ng.hr/mL||95% Confidence Interval|Geometric Mean
1452160|NCT00835978|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,|Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.|C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||hrs||Full Range|Median
1452161|NCT00835978|Secondary|Maximum Observed Plasma Concentration (Cmax) of Axitinib|Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.|Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose|The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.|||ng/mL||95% Confidence Interval|Geometric Mean
1452162|NCT00835978|Secondary|Overall Survival (OS)|OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Months||95% Confidence Interval|Median
1452163|NCT00835978|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (complete response - CR or Partial response - PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks|Subset of Full Analysis (FA) and Safety Analysis (SA) patients who achieved confirmed complete or partial response. FA included all randomized patients and was based on randomized treatment assignment regardless of whether or not study drug was administered. SA included all non randomized patients who received at least one dose of study medication.|||Months||95% Confidence Interval|Median
1452164|NCT00835978|Secondary|Progression-Free Survival (PFS)|The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Months||95% Confidence Interval|Median
1452165|NCT00835978|Primary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.|The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Percentage of Participants||95% Confidence Interval|Number
1452166|NCT00835926|Primary|Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay|Day 21 Post-vaccination|The Fluzone® antibody titers were analyzed in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1452167|NCT00835926|Primary|Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 21 Post-vaccination|The vaccine antibody fold rise analysis was in the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1452168|NCT00835926|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®|Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 21 Post-vaccination|The Geometric mean titers were analyzed in the per-protocol immunogenicity population.|||Titers||95% Confidence Interval|Geometric Mean
1452169|NCT00835926|Primary|Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®|"Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.~Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia"|Days 0 to 3 Post-vaccination|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
1452170|NCT00835900|Secondary|Rates of Smoking Cessation.|To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.|12 weeks after quit date.|ITT|||Participants|||Count of Participants
1452171|NCT00835900|Primary|Change in Smoking Behavior|Change in cigarettes per day from Week 2 to Week 5|Change in cigarettes per day from Week 2 to Week 5|ITT|||Change in Cigarettes Per Day||Standard Error|Mean
1452172|NCT00835861|Secondary|Number of Babies With Adverse Neonatal Outcomes|Resuscitation in the delivery room, preterm birth < 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.|Delivery until hospital discharge|"For 1 infant in the metformin group, the adverse neonatal outcome data was missing."|||number of babies|||Number
1452173|NCT00835861|Secondary|Number of Episodes Maternal Hypoglycemia|Maternal glucose < 60 mg/dL|Baseline throughout pregnancy until time of delivery||||Number of episodes|||Number
1452174|NCT00835861|Secondary|Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)|NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES <130|Baseline throughout pregnancy until time of delivery||||percent of glucose values|||Number
1452175|NCT00835861|Secondary|Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)|NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES <95|Baseline throughout pregnancy until time of delivery||||percent of glucose values|||Number
1452176|NCT00835861|Secondary|Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester||1st, 2nd, and 3rd trimester||||percentage of glycosolated hemoglobin||Inter-Quartile Range|Median
1452177|NCT00835861|Secondary|Number of Babies With Neonatal Hypoglycemia|Initial neonatal glucose < 40 mg/dL|Time of delivery through hospital discharge|For 1 infant in each group, the initial neonatal glucose value was missing.|||Number of babies|||Number
1452178|NCT00835861|Secondary|Maternal Weight Gain||Baseline throughout pregnancy until last prenatal visit.||||kg/week||Inter-Quartile Range|Median
1452179|NCT00835861|Secondary|Number of Patients With Obstetric Complications|Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.|Throughout pregnancy until hospital discharge following delivery.||||participants|||Number
1452180|NCT00835861|Primary|Blood Glucose Measurements|Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.|Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery|For 1 infant in each group, the initial neonatal glucose value was missing.|||mg/dL||Inter-Quartile Range|Median
1452181|NCT00835796|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452182|NCT00835796|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452183|NCT00835796|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452184|NCT00835731|Secondary|Women's Satisfaction With Cervical Ripening Method|"Scale:~1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied"|5 hours after placement of ripening agent||||units on a scale||Inter-Quartile Range|Median
1452185|NCT00835731|Secondary|Subject Pain During Dilation and Evacuation|"Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:~0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain~Higher values represent a worse outcome."|3-4 hours after placement of ripening agent||||Scores on a scale||Inter-Quartile Range|Median
1452186|NCT00835731|Secondary|Subject Pain During Ripening|"Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D&E procedure. Subjects were asked to rate pain on a 6 point Likert scale:~0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain~Higher values represent a worse outcome."|3-4 hours after placement of ripening agent||||Scores on a scale||Inter-Quartile Range|Median
1452187|NCT00835731|Secondary|Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt||3-4 hours after placement of ripening agent||||participants|||Number
1452188|NCT00835731|Secondary|Procedure Time for Dilation and Evacuation||3-4 hours after placement of ripening agent||||minutes||Inter-Quartile Range|Median
1452189|NCT00835731|Secondary|Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report|"Scale:~None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)"|3-4 hours after placement of ripening agent||||Participants|||Count of Participants
1452190|NCT00835731|Primary|Cervical Dilation in Women Following Exposure to Either Ripening Agent||3-4 hours after placement of ripening agent||||mm||Standard Deviation|Mean
1452191|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452192|NCT00835705|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452193|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Clavulanic Acid|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452194|NCT00835705|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin|Bioequivalence based on AUC0-t|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452195|NCT00835705|Primary|AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin|Bioequivalence based on AUC0-inf|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452196|NCT00835705|Primary|Cmax (Maximum Observed Concentration) - Amoxicillin|Bioequivalence based on Cmax|Blood samples were collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452197|NCT00835692|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452198|NCT00835692|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-t|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452199|NCT00835692|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 48 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452200|NCT00835679|Secondary|Number of Patients With the Given Severity of Post-operative Complications Within the Specified Duration||From day 15 (day of surgery) to 30 days after surgery|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers.No patients received any study drugs. This study was closed prematurely due to slow accrual.||||||
1452201|NCT00835679|Secondary|Number of Patients With the Given Severity of Adverse Event Within a Specified Duration|Number of patients with each grade of adverse event (AE) during the specified timeframe using the Common Terminology Criteria for AEs guide, grades 1-5 with one being mild, five is death.|weekly to day 15, and at followup on day 30|No patients accrued to Cohorts B, C, and D, which were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No patients were accrued to Cohorts B, C, D. This study was closed prematurely due to slow accrual.||||||
1452202|NCT00835679|Secondary|Patients With Reduction of Biomarkers in Tumor Tissue|Patients with pre-to-post treatment reduction at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker: total & phi-EGFR, phi-MAPK, phi-Akt, Ki67, phi-FAK, phi-paxillin, phi-Src, capase 3. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for biomarker in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%)|study entry to day 15|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.||||||
1452226|NCT00835510|Secondary|Clinical Cure|"The following 8 signs and symptoms are rated at each visit:~Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning~Each symptom is evaluated using the following scale:~0 = None- Complete absence of any sign or symptom~= Mild – obvious but minimal involvement~= Moderate – something that is easily noted~= Severe – quite marked~Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2."|42 days|ITT population|||Participants|||Number
1452203|NCT00835679|Primary|Patients With a Biologic Response|Patients who experienced a pre-to-post treatment reduction of at least 1 scoring level from baseline on preoperative-day 15 in at least 1 biomarker of the pathway being inhibited: epidermal growth factor (EGFR) for Cohort B, sarcoma (Src) for Cohort C, and both EGFR and Src for Cohort D. Blood for these biomarkers will be taken on day of baseline and pre-operatively on day 15. Determined by 0-4-scale scoring with score determined by percentage of tumor cells positively stained for pathway in question: minimum 0 (0%), 1 (1-24%), 2 (25-49%), 3 (50-74%), and maximum 4 (75-100%).|on baseline and preoperatively on day of surgery (day 15)|No patients accrued to Cohorts B, C, and D, who were to receive the study drugs. Nine patients were accrued in Cohort A; these patients received no study drugs and were to determine normal levels of selected biomarkers. No biomarkers were determined; no data available. This study was closed prematurely due to slow accrual.||||||
1452204|NCT00835666|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452205|NCT00835666|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452206|NCT00835666|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452207|NCT00835640|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452208|NCT00835640|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452209|NCT00835640|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452210|NCT00835614|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452211|NCT00835614|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452212|NCT00835614|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452213|NCT00835588|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452214|NCT00835588|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Not all subjects data could be used to estimate AUC0-inf.|||ng*h/mL||Standard Deviation|Mean
1452215|NCT00835588|Primary|Cmax - Maximum Observed Concentration - Pantoprazole in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452216|NCT00835575|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1452217|NCT00835575|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1452218|NCT00835575|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1452219|NCT00835549|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452220|NCT00835549|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452221|NCT00835549|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452222|NCT00835536|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452223|NCT00835536|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452224|NCT00835510|Primary|Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra|Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).|42 days|Patients with negative cultures excluded. Use per protocol population|||Participants|||Number
1452229|NCT00835510|Primary|Therapeutic Cure - Superiority Analysis|"Therapeutic Cure requires both Clinical Cure and Mycological Cure.~Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure.~Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative."|42 days|Patients with negative cultures at baseline are excluded. Efficacy ITT analysis includes all patients with positive baseline cultures, who received at least one dose of medication, had a follow-up visit and had data for the day 42 visit.|||Participants|||Number
1452230|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]- Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452231|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452232|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452233|NCT00835497|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452234|NCT00835497|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]- Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452235|NCT00835497|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452236|NCT00835484|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452237|NCT00835484|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452238|NCT00835484|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452239|NCT00835406|Primary|Bioequivalence Based on Ae0-36|Ae0-36 = cumulative urine excretion|Urine collected over 36 hour period||||ng/mL||Standard Deviation|Geometric Mean
1452240|NCT00835406|Primary|Bioequivalence Based on Rmax|Rmax = maximum rate of urinary excretion|Urine collected over 36 hour period||||ng/mL||Standard Deviation|Geometric Mean
1452241|NCT00835380|Secondary|Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination|All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject’s temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.|For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccination|Safety population, defined as all subjects who were vaccinated at least one dose and had safety follow-up data|||participants|||Number
1452242|NCT00835380|Primary|Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.|"Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines.~HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer < 50 mIU/mL."|Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)|Per-protocol population, defined as all HAV-susceptible subjects who completed the vaccination regimen within acceptable day ranges, had 2 valid serology results on Day 0 and Month 7, and met all inclusion/exclusion criteria.|||Percentage of Participants|||Number
1452243|NCT00835367|Secondary|AUC0-t - Benazeprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452244|NCT00835367|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452245|NCT00835367|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452249|NCT00835367|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
1452250|NCT00835367|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
1452251|NCT00835367|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg/mL||Standard Deviation|Mean
1452252|NCT00835354|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452253|NCT00835354|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452254|NCT00835354|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452255|NCT00835341|Secondary|Cancer-free Survival Time for Patients With Oral Epithelial Dysplasia||from 3 months to 124 months|||||||
1452256|NCT00835341|Primary|The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia|The follow-up examination was carried out with a 3-month interval. Re-biopsy was done as clinically indicated, e.g. the lesion recurs or has tendency for malignant development. Pathologic diagnosis was made by at least two pathologists without the knowledge of baseline p16 methylation, based on the World Health Organization's criteria, at Peking University School of Stomatology. The number of participants with malignant transformation of oral dysplasia was calculated based on the number of participants with oral dysplasia progressed to carcinoma by the end of the trial in each cohorts.|from 3 months to 124 months||||participants|||Number
1452257|NCT00835276|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452258|NCT00835276|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452259|NCT00835276|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 48 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452260|NCT00835263|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452261|NCT00835263|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452262|NCT00835263|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452263|NCT00835237|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|From the vaccination up to Day 182||||subjects|||Number
1452264|NCT00835237|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within the 31-day (Day 0-30) post-vaccination period||||subjects|||Number
1452265|NCT00835237|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, and fever|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results|||subjects|||Number
1452266|NCT00835237|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|Within the 4-day (Day 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort on subjects with available results|||subjects|||Number
1452267|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off, Using Alternative Definitions.|"Vaccine response using alternative definitions defined as:~For initially seronegative subjects (< 5 EL.U/mL ), antibody concentration ≥ 10 EL.U/mL one month after vaccination.~For initially seropositive subjects (≥ 5 EL.U/mL), antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1452300|NCT00835172|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for three subjects.|||ng*h/mL||Standard Deviation|Mean
1452268|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentrations Above the Cut-off|"Booster response defined as :~For initially seronegative subjects (< 5 EL.U/mL), antibody concentration ≥ 20 EL.U/mL one month after vaccination.~For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration < 20 EL.U/mL: antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects (≥ 5 EL.U/mL) with pre-vaccination antibody concentration ≥ 20 EL.U/mL : antibody concentration one month after vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1452269|NCT00835237|Secondary|Number of Subjects With Vaccine Response for Anti-T and Anti-D Antibodies Concentrations Above the Cut-off|"Booster response defined as :~For initially seronegative subjects (< 0.1 IU/mL), antibody concentration ≥ 0.4 IU/mL one month after vaccination.~For initially seropositive subjects (≥ 0.1 IU/mL): antibody concentration one month after vaccination ≥ 4 fold the pre-vaccination antibody concentration."|One month after vaccination|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1452270|NCT00835237|Secondary|Anti-T and Anti-D Antibody Concentrations|Concentrations for anti-T and anti-D antibodies given as GMC in IU/mL.|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||IU/mL||95% Confidence Interval|Geometric Mean
1452271|NCT00835237|Primary|Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration|Concentration for anti-PT, anti-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per millilitre (EL.U/mL)|Before (PRE) and one month after vaccination (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results|||EL.U/mL||95% Confidence Interval|Geometric Mean
1452272|NCT00835237|Primary|Number of Subjects With Antibody Concentration Against Vaccine Antigens, Above a Protocol Defined Cut-off Value|"Antibodies against vaccine antigens assessed were: anti-diphtheria (anti-D) and anti-tetanus (anti-T).~Anti-D antibody cut-off value assessed was ≥ 0.1 International Unit per milliliter (IU/mL)~Anti-T antibody cut-off values assessed were ≥ 0.1 IU/mL and ≥ 1.0 IU/mL"|One month after vaccination.|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results|||subjects|||Number
1452273|NCT00835224|Primary|Blood Pressure||Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration||||mmHg||Standard Deviation|Mean
1452274|NCT00835211|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg*h/mL||Standard Deviation|Mean
1452275|NCT00835211|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 12 hour period|AUC0-inf could not be estimated for one subject in the reference arm.|||pg*h/mL||Standard Deviation|Mean
1452276|NCT00835211|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||pg/mL||Standard Deviation|Mean
1452277|NCT00835198|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of lesions||Standard Deviation|Mean
1452278|NCT00835198|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
1452279|NCT00835198|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
1452280|NCT00835198|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12|Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of Lesions||Standard Deviation|Mean
1452281|NCT00835185|Secondary|Kirsten Rat Sarcoma (KRAS) Mutation Status|Tumor tissues collected prior to study drug administration were evaluated for the presence or absence of KRAS mutations by a retrospective analysis.|Baseline|All enrolled participants who had assessment of tumor tissue samples at baseline.|||participants|||Number
1452282|NCT00835185|Secondary|Change From Baseline in Tumor Size||Baseline, 29 Months|Zero participants were analyzed, the outcome measure was registered in error.||||||
1452283|NCT00835185|Secondary|Vss at Study Day 1 of Cycles 2 Through 6||Day 1 Cycles 2 through 6 predose and 1 hour postdose|Zero participants were analyzed, Vss results were not collected.||||||
1452288|NCT00835185|Secondary|Volume of Distribution (Vss) of IMC-11F8 at Study Day 1 of Cycle 1|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate Vss.|||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
1452289|NCT00835185|Secondary|Clearance (CL) of IMC-11F8 at Study Day 1 of Cycle 1|CL is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate CL.|||milliliters/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1452290|NCT00835185|Secondary|Half-Life (t1/2) of IMC-11F8 at Study Day 1 of Cycle 1|The t1/2 is the time measured for the plasma concentration of the drug to decrease by one half.|Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate t1/2.|||hours (h)||Full Range|Geometric Mean
1452291|NCT00835185|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had PK data available to calculate AUC(0-∞).|||micrograms*hour/milliliter (µg*h/mL)]||Geometric Coefficient of Variation|Geometric Mean
1452292|NCT00835185|Secondary|Maximum Concentration (Cmax) of IMC-11F8 at Study Day 1 of Cycle 1||Cycle 1 Day 1 predose, immediately after infusion, and 1, 2, 4, 24, 72, 96, 144, 168 and 236 hours postdose|All enrolled participants who received any quantity of study drug and had pharmacokinetic (PK) data available to calculate Cmax.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1452293|NCT00835185|Secondary|Serum Anti-IMC-11F8 Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-IMC-11F8 response if there were 2 consecutive positive samples or if the final sample tested is positive. Participants with a baseline sample positive for anti-IMC-11F8 antibodies were considered unevaluable for immunogenicity. A sample was considered positive for IMC-11F8 antibodies if it exhibited a post-baseline treatment emergent antibody level that exceeded the upper 95% confidence interval of the mean determined from the normal anti-IMC 11F8 level found in healthy treatment-naïve individuals.|Baseline up to last day of treatment plus 45 days after last treatment (127 weeks)|All participants who received any amount of study drug and were IMC-11F8 antibody negative at baseline.|||participants|||Number
1452294|NCT00835185|Secondary|Duration of Response|The duration of response was defined as the time from first confirmed CR or PR to the first time of PD or death due to any cause. CR, PR and PD were defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target and non-target lesions; PR was defined as a ≥30% decrease in the sum of the LD of the target lesions, taking as reference the baseline sum of the LD; PD was defined as a ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. Participants with CR or PR who had no PD or death at the time of the data inclusion cutoff, the duration of response was censored at their last contact.|Time of response to time of measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug and had confirmed CR or PR. Participants censored =2.|||months||95% Confidence Interval|Median
1452295|NCT00835185|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) or Death|The number of participants who experienced AEs, SAEs or death during the study and within 30 days of last dose. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|First dose to end of treatment and 30-day post treatment follow-up up to 31 months|All enrolled participants who received any quantity of study drug.|||participants|||Number
1452296|NCT00835185|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive disease (PD) was determined using RECIST v1.0 criteria. PD was defined as ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum of the LD recorded since treatment started or the appearance of new lesions and/or unequivocal progression of existing nontarget lesions. PFS was estimated by the Kaplan-Meier method. Participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last tumor assessment prior to the earliest of the following events: 2 or more missed visits, additional cancer treatment or the end of the follow-up period.|First dose to measured PD or death up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =13.|||months||95% Confidence Interval|Median
1452297|NCT00835185|Secondary|Overall Survival (OS)|OS was defined as the duration from the date of first dose to the date of death from any cause. OS was estimated by the Kaplan-Meier method. Participants who were alive at the time of the data inclusion cutoff or lost to follow-up, OS was censored at the last contact.|First dose to date of death from any cause up to 30 months|All enrolled participants who received any quantity of study drug. Participants censored =14.|||months||95% Confidence Interval|Median
1452298|NCT00835185|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response )|CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence) / (total number of participants treated) * 100.|Up to 30 Months|All enrolled participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1452299|NCT00835172|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452301|NCT00835172|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452302|NCT00835159|Primary|Incidence of POD|Is the incidence of POD not affected by rivastigmine treatment or not.|72 hours postoperatively||||participants|||Number
1452303|NCT00835146|Primary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)|Bioequivalence based on AUC0-72.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452304|NCT00835146|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452305|NCT00835120|Secondary|Change in Clinical Global Impressions-Bipolar Version (CGI-BP)|The CGI-BP asks the clinician one question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.|Week 0 - Week 8||||units on a scale||Standard Error|Least Squares Mean
1452306|NCT00835120|Secondary|Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores|A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.|Week 0 - Week 8||||participants|||Number
1452307|NCT00835120|Secondary|Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)|A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.|Week 0 - Week 8||||participants|||Number
1452308|NCT00835120|Secondary|Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score|The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome|Week 0 - Week 8||||units on a scale||Standard Error|Least Squares Mean
1452309|NCT00835120|Primary|Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score|Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome|Week 0 - Week 8||||units on a scale||Standard Error|Least Squares Mean
1452310|NCT00835081|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452311|NCT00835081|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452312|NCT00835081|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452313|NCT00835068|Secondary|Subjective Assessment of Ease of Use by Participant|Participants assessed ease of use of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.|||participants|||Number
1452314|NCT00835068|Secondary|Subjective Assessment of Efficacy by Physician|Participating physician assessed efficacy of BeneFIX as very good, good, moderate and bad at follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the physician.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.|||participants|||Number
1452315|NCT00835068|Secondary|Dose Per Injection of BeneFIX|Dose per injection during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, ‘n’ signifies participants evaluable for this measure during the specified treatment period.|||IU/kg||Standard Deviation|Mean
1452316|NCT00835068|Secondary|Subjective Assessment of Efficacy by Participant|Participants assessed efficacy of BeneFIX as very good, good, moderate and bad at each follow-up visit. Results were summarized for the latest (most recent), worst and best assessment of BeneFIX done by the participant.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX.|||participants|||Number
1452317|NCT00835068|Secondary|Total Consumption of BeneFIX|Total consumption of BeneFIX included consumption during prophylaxis, on demand, during bleeding episodes, preventive injections, surgeries or immune tolerance.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX. Participants with at least one follow-up visit were evaluable for this outcome measure.|||International Unit (IU)||Standard Deviation|Mean
1452331|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452332|NCT00835003|Secondary|Pediatric Admission and Morbidity||From birth until 2 years of age|||||||
1452333|NCT00835003|Secondary|Pediatric Admission and Morbidity||2 months post partum|||||||
1452334|NCT00835003|Secondary|Post Partum Depression||2 months|||||||
1452335|NCT00835003|Secondary|Maternal Satisfaction With Timing of Elective Caesarean Section||2 months|||||||
1452318|NCT00835068|Secondary|Number of Bleeding Episodes Requiring Treatment by Injection|Number of injections (1, 2, 3 or greater than or equal to [>= 4]) required to treat the bleeding episodes during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme.|Baseline up to Year 4.75|Efficacy population. Efficacy population included only those participants who were previously treated with BeneFIX. Here, 'number of bleeding episodes analyzed' signifies episodes evaluable for this measure. ‘n’ signifies those bleeding episodes with injection data available during specified period.|||bleeding episodes|Participants||Number
1452319|NCT00835068|Secondary|Number of Bleeding Episodes|Number of bleeding episode during prophylaxis and on demand period were reported. All periods with at least one injection per week were considered as prophylaxis period. All prophylaxis periods of less than a month were reviewed and cross-checked with the treatment scheme planned at the previous visit to confirm if they were real prophylaxis periods or preventive injections periods. On demand treatment period included the total duration of follow up excluding duration of both prophylaxis and preventive injection treatment scheme. Efficacy population included only those participants who were previously treated with BeneFIX. Here, ‘n’ signifies participants evaluable for this measure during the specified treatment period. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Efficacy population: participants with basal FIX activity less than or equal to (<=) 1 percent (%) with real exposure days in diary at least 70% of planned exposure days for prophylaxis period, and without FIX inhibitor before or during study (no FIX inhibitor history at baseline; FIX inhibitor titer <0.6 Bethesda Unit [BU] during follow up).|||bleeding episodes|||Number
1452320|NCT00835068|Primary|Number of Participants With Events of Special Interest|Events of special interest included allergic reactions, red blood cell (RBC) agglutination phenomena, lack of efficacy/low recovery, thrombotic events and onset of factor IX (FIX) inhibitor. Participants may be represented in more than 1 category.|Baseline up to Year 4.75|Safety population included all participants who received at least one dose of BeneFIX.|||participants|||Number
1452321|NCT00835068|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Relationship After Safety Amendment|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug as per participating physician. AEs included SAEs as well as non-serious AEs which occurred after the safety amendment. After the safety amendment, all AEs/SAEs were collected irrespective of their relationship to BeneFIX.|Year 3.5 up to 4.75|Safety population included all participants who received at least one dose of BeneFIX. Previously untreated participants were not evaluable for this outcome measure due to discontinuation prior to safety amendment.|||participants|||Number
1452322|NCT00835068|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs which occurred prior to safety amendment. Prior to safety amendment, only AEs/SAEs deemed related to BeneFIX as per participating physician were collected.|Baseline up to Year 3.5|Safety population included all participants who received at least one dose of BeneFIX.|||participants|||Number
1452323|NCT00835042|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452324|NCT00835042|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452325|NCT00835042|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452326|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452327|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452328|NCT00835042|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452329|NCT00835042|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452330|NCT00835042|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452341|NCT00834990|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
1452342|NCT00834990|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
1452343|NCT00834990|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg/mL||Standard Deviation|Mean
1452344|NCT00834977|Secondary|AUC0-t - Benazaprilat|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452345|NCT00834977|Primary|AUC0-t - Benazepril|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
1452346|NCT00834977|Primary|AUC0-inf - Benazepril|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis|||ng*h/mL||Standard Deviation|Mean
1452347|NCT00834977|Secondary|AUC0-inf - Benazeprilat|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452348|NCT00834977|Secondary|Cmax - Benazeprilat|Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452349|NCT00834977|Primary|Cmax - Benazepril|Bioequvialence based on Cmax - Maximum observed concentration|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452350|NCT00834977|Primary|AUC0-t - Amlodipine|Bioequivalence based on AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
1452351|NCT00834977|Primary|AUC0-inf - Amlodipine|Bioequivalence based on AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg*h/mL||Standard Deviation|Mean
1452352|NCT00834977|Primary|Cmax - Amlodipine|Bioequivalence based on Cmax - Maximum observed concentration|Blood samples collected over 168 hour period|One subject was excluded from all statistical analysis for Amlodipine based on a pre-dose plasma concentration greater than 5% of the Cmax value.|||pg/mL||Standard Deviation|Mean
1452353|NCT00834964|Secondary|AUC0-t - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
1452354|NCT00834964|Secondary|AUC0-inf - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
1452355|NCT00834964|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng/mL||Standard Deviation|Mean
1452356|NCT00834964|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
1452357|NCT00834964|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng*h/mL||Standard Deviation|Mean
1452358|NCT00834964|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from first 24 completed subjects were included in the statistical analysis per protocol.|||ng/mL||Standard Deviation|Mean
1452359|NCT00834912|Secondary|t1/2|Apparent terminal elimination half-life (t1/2)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variable T1/2 of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.|||hours||Standard Deviation|Mean
1452360|NCT00834912|Secondary|Tmax|Time to maximum plasma concentration (Tmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.|||hours||Full Range|Median
1452361|NCT00834912|Primary|Cmax|Maximum plasma concentration (Cmax)|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.|||ng/mL||Standard Deviation|Mean
1452362|NCT00834912|Primary|AUC(0-∞)|"The area under the plasma concentration (AUC) curve was estimated by extrapolating to infinity AUC0–t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R’2 (coefficient of determination). The units are ng.h/mL.~h=hours"|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented. The pharmacokinetic variables AUC(0-∞) of one subject for Tramadol HCl 300 mg (Confab Laboratories) fasting were not used in the analyses due to the morphology of the plasma concentration-time curves.|||ng.h/mL||Standard Deviation|Mean
1452363|NCT00834912|Primary|AUC(0-t)|Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.|48 hours|Data from all randomized subjects who completed at least 2 periods of the study are presented.|||ng.h/mL||Standard Deviation|Mean
1452364|NCT00834899|Primary|Change in Platelet Count|Change in platelet counts occurring anytime from randomization up to day 35 (final follow-up visit).|Up to 35 days||||x 10^9/L||Full Range|Median
1452365|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Hospitalization|The duration of hospitalization will be defined as the period from randomization to the time an order for discharge from the hospital is written.|Up to 7 days|Intention to treat|||Days||Full Range|Median
1452366|NCT00834899|Secondary|Effect of Eptifibatide on Duration of Acute Pain Episodes|"The duration of the pain episode will be defined as the time from randomization to termination of the pain episode. The pain episode will be considered terminated when the patient states that the crisis is resolved (defined as being ready to go home on oral analgesics) or all of the following criteria are met:~Pain relief (pain scores ≤ 40) maintained for at least 2 consecutive readings (assessed using a visual analog scale with measurements from 0 - 100, where 0 is no pain and 100 is worst imaginable pain).~No parenteral analgesics have been administered for at least 12 hours.~Ability to walk normally (unless he/she was unable to walk for some other reason prior to the crisis onset)."|Up to 7 days|Intention to treat|||Days||Full Range|Median
1452367|NCT00834899|Primary|1) Major Bleeding Episodes|Major bleeding episodes are defined as any episode, such as gastrointestinal bleeding or intracranial bleed that typically leads to hospitalization or other prolonged bleeding requiring a blood transfusion|Up to 35 days|Intention to treat|||participants|||Number
1452368|NCT00834886|Primary|To Investigate the Efficacy on Sleep Onsel Latency of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|Actigraphy, sleep onset latency (SOL). An actigraph is a wrist-worn movement sensor that objectively record motor activity. Participants used an event button to mark bed time and rise time. The actiwatch is waterproof and participants were instructed not to take it off at any time during the data collection peroid.|1 day after 2-week treatment ended||||Minutes||Standard Deviation|Mean
1452369|NCT00834886|Primary|To Investigate the Efficacy on Subjective Sleepiness of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Subjective sleepiness; Karolinska sleepiness scale (KSS). The KSS is a scale in which the subjects rate their concurrent sleepiness level. The scale is verbally anchored with steps ranging from 1 (very alert) to 9 (very sleepy, fighting sleep, effort to stay awake)."|1 day after 2-week treatment ended|All participants in the four arms|||units on a scale||Standard Deviation|Mean
1452370|NCT00834886|Primary|To Investigate the Efficacy on Rise Time of Bright Light Therapy and Melatonin Treatment Using a 4 Armed Placebo Controlled Design. Main Outcome Measures: Sleep Log, Actigraphy and Psychological Tests.|"Sleep diary, rise time (when participants rise from bed in the morning, self-report) before and after a randomized controlled 4 armed treatment study including a follow-up 3 months later.~Midnight is 0000; in the outcome measure table the value is given in minutes after midnight.~i.e. 530 equals 08:50 in the morning."|1 day after two-week treatment ends||||Minutes||Standard Deviation|Mean
1452371|NCT00834873|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452372|NCT00834873|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452373|NCT00834873|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452374|NCT00834834|Secondary|Number of Participants With Suicide Events|Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual’s actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.|measured after 6 months of treatment||||participants|||Number
1452375|NCT00834834|Primary|Suicide Events|Data on suicidal behavior was collected with the Columbia Suicide History Interview (CSHI), a semi-structured interview developed by our group. It is used to elicit history of the individual’s actual suicide attempts , as well as specific questions concerning the circumstances surrounding any suicidal behavior and its degree of medical lethality. In addition to obtaining measurements of actual suicide attempts, the CSHI also captures suicide-related behaviors such as aborted and interrupted suicide attempts. An actual suicide attempt is operationally defined by the CSHI as a self-injurious act performed with at least some intent to die.|Measured after 6 months of treatment||||suicide events|||Number
1452376|NCT00834808|Secondary|t1/2|Apparent terminal elimination half-life|48 hours||||hours||Standard Deviation|Mean
1452377|NCT00834808|Secondary|Tmax|Time to maximum plasma concentration|48 hours||||hours||Full Range|Median
1452378|NCT00834808|Primary|Cmax|Maximum plasma concentration.|48 hours||||ng/mL||Standard Deviation|Mean
1452379|NCT00834808|Primary|AUC(0-inf)|Area under the plasma concentration versus time curve extrapolated to infinity. h = hours|48 hours||||ng.h/mL||Standard Deviation|Mean
1452380|NCT00834808|Primary|AUC(0-t)|"Area under the plasma concentration versus time curve to the last measurable concentration.~h = hours"|48 hours||||ng.h/mL||Standard Deviation|Mean
1452381|NCT00834795|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452382|NCT00834795|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452383|NCT00834795|Primary|Cmax - Maximum Observed Concentration - Carvedilol in Plasma|Bioequivalence based on Cmax|Blood samples collected over 60 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452384|NCT00834756|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration (Per Participant) - Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452385|NCT00834756|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452386|NCT00834756|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452387|NCT00834743|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1452388|NCT00834743|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452389|NCT00834743|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452390|NCT00834717|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Bl;ood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452391|NCT00834717|Primary|Auc0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452392|NCT00834717|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452393|NCT00834678|Secondary|Relationship of EGFR Expression or Amplification, Basal-like Tumors, and DNA Damage-repair Checkpoint Activation With ORR, CBR, DR, and OS||up to two years|Correlative studies to assess EGFR expression and gene amplification, were planned, but not collected because of early trial termination.||||||
1452394|NCT00834678|Secondary|Overall Survival (OS)||from time of study enrollment until death, for up to 2 years||||months||95% Confidence Interval|Median
1452395|NCT00834678|Secondary|Duration of Response (DR)||Up to two years||||months to progression||95% Confidence Interval|Median
1452396|NCT00834678|Secondary|Clinical Benefit Rate (CBR)||Up to two years|The data was not collected and analyzed||||||
1452397|NCT00834678|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to two years||||patients|||Number
1452398|NCT00834678|Primary|Progression-free Survival at 6 Months and 12 Months (Phase II)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to two years||||months||95% Confidence Interval|Mean
1452399|NCT00834678|Primary|Dose-limiting Toxicity (Phase I)||Up to two years||||patients|||Number
1452400|NCT00834678|Primary|Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)|28 day cycle included intravenous erlotinib on days 15-21.|Up to two years||||mg|||Number
1452401|NCT00834678|Primary|Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)|28 day cycle included intravenous bendamustine on days 1 and 2.|Up to two years||||mg/m^2|||Number
1452402|NCT00834652|Primary|Change of Beck Depression Inventory-II Scores Over 16 Weeks|Beck Depression Inventory-II (BDI) scores 0-63, minimum score =0, maximum score =63, Higher scores represent worse outcome. Baseline scores are compared to scores after treatment.|Measured at Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
1452403|NCT00834639|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
1452404|NCT00834639|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg*h/mL||Standard Deviation|Mean
1452405|NCT00834639|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||µg/mL||Standard Deviation|Mean
1452406|NCT00834626|Secondary|Percentage of Participants Achieving Remission in Hypertension|Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication|1 year||||Percentage of Participants|||Number
1452407|NCT00834626|Primary|Percentage of Participants Having Remission of Type 2 Diabetes|The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped|One year||||Percentage of Participants|||Number
1452408|NCT00834626|Secondary|Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents|Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year|one year||||Percentage of Participants|||Number
1452409|NCT00834626|Secondary|Percentage of Participants Not Requiring Insulin|After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months|1 year||||Percentage of Participants|||Number
1452410|NCT00834613|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452411|NCT00834613|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452412|NCT00834613|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 36 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452413|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452414|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one completed subject could not be used to estimate AUC0-inf.|||ng*h/mL||Standard Deviation|Mean
1452415|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Metformin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452416|NCT00834587|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Glipizide|Bioequivalence based on AUC0-t|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452417|NCT00834587|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Glipizide|Bioequivalence based on AUC0-inf|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452418|NCT00834587|Primary|Cmax (Maximum Observed Concentration) - Glipizide in Plasma|Bioequivalence based on Cmax|Blood samples collected over 36 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452419|NCT00834574|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452420|NCT00834574|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452421|NCT00834574|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452422|NCT00834561|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452423|NCT00834561|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452424|NCT00834561|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 120 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452425|NCT00834535|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452426|NCT00834535|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452427|NCT00834535|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 14 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452428|NCT00834522|Primary|AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)]|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452429|NCT00834522|Primary|AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)]|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452430|NCT00834522|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452431|NCT00834483|Secondary|Visual Analog Score, Cosmesis|"Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis.~1 is an unacceptable or poor perspective in regards to wound cosmesis."|6 months|Power analysis described above|||units on a scale (1 is a low score)||Full Range|Mean
1452432|NCT00834483|Secondary|Cost-analysis|Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs|1 year|Power analysis was performed as above.|||Dollars||Standard Deviation|Mean
1452433|NCT00834483|Primary|Closure Time|We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated.|6 months|A power analysis was performed based on mean closure times by the 2 surgeons and determined that a sample size of 23 patients in each group would provide 90% power to detect a 50% difference in closure time. To account for patients being lost to FU, we enrolled 29 to the traditional closure group and 31 to the barbed closure group|||Average time in minutes||Full Range|Mean
1452434|NCT00834444|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452435|NCT00834444|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452436|NCT00834444|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed. Data from one withdrawn subject was also included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452437|NCT00834431|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452438|NCT00834431|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452439|NCT00834431|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452440|NCT00834418|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452441|NCT00834418|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452442|NCT00834405|Primary|AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post-dose (Per Participant) - Metabolite A77 1726|Bioequivalence based on AUC0-72|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452443|NCT00834405|Primary|Cmax - Maximum Observed Concentration - Metabolite A77 1726 in Plasma|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452444|NCT00834366|Secondary|t1/2|Apparent terminal elimination half-life|48 hours||||hours||Standard Deviation|Mean
1452445|NCT00834366|Primary|Cmax|Maximum plasma concentration|48 hours||||ng/mL||Standard Deviation|Mean
1452446|NCT00834366|Primary|AUC(0-Inf)|Area under plasma concentration versus time curve extrapolated to infinity. Unit is ng.h/mL. h=hour.|48 hours||||ng.h/mL||Standard Deviation|Mean
1452447|NCT00834366|Secondary|Tmax|Time to the maximum concentration|48 hours||||hours||Full Range|Median
1452448|NCT00834366|Primary|AUC(0-t)|Area under plasma concentration versus time curve to the last measurable concentration. Unit is ng.h/mL. h=hours.|48 hours||||ng.h/mL||Standard Deviation|Mean
1452449|NCT00834340|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452450|NCT00834340|Primary|AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUCinf|Blood samples collected over 24 hour period|The parameter of AUCinf could not be estimated for one subject.|||ng*h/mL||Standard Deviation|Mean
1452451|NCT00834340|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452452|NCT00834288|Secondary|Plateau Time (T75%Cmax)|Time over which plasma concentrations were above 75% Cmax on day 5. 24h = 24 hours.|24 hours (day 5)||||hours||Standard Deviation|Mean
1452453|NCT00834288|Secondary|Half-value Duration (HVD)|Time over which plasma concentrations were above one half Cmax on day 5. 24h = 24 hours.|24 hours (day 5)||||hours||Standard Deviation|Mean
1452454|NCT00834288|Secondary|Percentage Swing|"Percentage swing is a pharmacokinetic parameter recommended by the FDA for submission and is calculated as follows:((Cmax,ss - Cmin,ss)/Cmin,ss)*100. It was calculated over 24 hours on day 5.~Where:~Cmax,ss = Maximum concentration at steady state; Cmin,ss = Minimum concentration at steady state."|24 hours (day 5)||||percentage of fluctuation||Standard Deviation|Mean
1452455|NCT00834288|Secondary|Percentage Peak-trough Fluctuation (% PTF)|"Percentage peak-trough fluctuation over 24 hours (24h) at steady state on day 5.~Percent peak-to-trough fluctuation is calculated as (Cmax - Cmin)/Cav*100, where Cmax is the maximum observed concentration, Cmin is the minimum observed concentration and Cav is the average concentration over 24 hours (where Cav = AUCss/24)."|24 hours (day 5)||||percentage of fluctuation||Standard Deviation|Mean
1452456|NCT00834288|Secondary|Time to Peak Exposure (Tmax)|Time to peak exposure over 24 hours (24h) at steady state on day 5.|24 hours (day 5)||||hours||Full Range|Median
1452457|NCT00834288|Secondary|Minimum Plasma Concentration at Steady State(Cmin,ss)|Minimum plasma concentration over 24 hours (24h) at steady state on day 5. ss = steady state.|24 hours (day 5)||||ng/mL||Standard Deviation|Mean
1452458|NCT00834288|Secondary|Maximum Plasma Concentration at Steady State(Cmax,ss)|Maximum plasma concentration over 24 hours (24h) at steady state, on day 5. ss = steady state.|24 hours (day 5)||||ng/mL||Standard Deviation|Mean
1452459|NCT00834288|Primary|Area Under the Plasma Concentration Versus Time Data Pairs at Steady State (AUCss)|"Area under the plasma concentration versus time data pairs over 24 hours (24h) at steady state, on day 5.~ss = steady state. AUCss is also known as AUCtau."|24 hours (day 5)||||ng*h/mL||Standard Deviation|Mean
1452460|NCT00834275|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452461|NCT00834275|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 12 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452462|NCT00834275|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 12 hour period|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452463|NCT00834249|Secondary|AUC0-t - O-desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452464|NCT00834249|Secondary|AUC0-inf - O-desmethylvenlafazine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452465|NCT00834249|Secondary|Cmax - O-Desmethylvenlafaxine in Plasma|Informational Purposes Only|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452466|NCT00834249|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452467|NCT00834249|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452468|NCT00834249|Primary|Cmax - Maximum Observed Concentration - Venlafaxine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452469|NCT00834236|Primary|Number of Participants With Accurate Diagnosis for Gastric Cancer|Normal subject group: number of the subjects with normal alpha 1-antitrypsin level in gastric juice Gastric cancer group: number of the subjects with elevated alpha 1-antitrypsin level in gastric juice|2 months||||participants|||Number
1452470|NCT00834210|Secondary|Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|"Change from baseline in non-inflammatory lesion counts(open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement)."|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of lesions||Standard Deviation|Mean
1452471|NCT00834210|Secondary|Change From Baseline in Overall Disease Severity at Week 12|Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Scores on a scale||Standard Deviation|Mean
1452472|NCT00834210|Secondary|Change From Baseline in Investigator Global Assessment at Week 12|Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized)|||Scores on a scale||Standard Deviation|Mean
1452473|NCT00834210|Primary|Change From Baseline in Inflammatory Lesion Counts (Papules,Pustules, and Nodules) at Week 12|Change from baseline in inflammatory lesion count (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 12|Intent-to-treat (ITT), which included all patients who started the study (randomized).|||Number of Lesions||Standard Deviation|Mean
1452474|NCT00834197|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1452475|NCT00834197|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1452476|NCT00834197|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 120 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1452477|NCT00834171|Primary|Mean Elevated Intraocular Pressure (IOP) During Treatment|Mean elevated IOP during treatment. IOP is a measurement of the fluid pressure inside the eye. IOP was recorded any time an elevation of IOP (increase of 5 mmHg or more) occurred while using study treatment. The median duration of treatment at the time of observed IOP elevation was 55 days.|55 days|Intent to treat, which included all patients in the study.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1452478|NCT00834132|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452479|NCT00834132|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452480|NCT00834132|Primary|Cmax - Maximum Observed Concentration - Azithromycin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452481|NCT00834106|Secondary|Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update)|The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.|Up to 78 months|The population analyzed included participants 20 to 26 years of age at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
1452482|NCT00834106|Secondary|Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update)|The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.|Up to 78 months|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
1452483|NCT00834106|Primary|Entire Study: Percentage of Participants Who Died|The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm|Up to approximately 90 months|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
1452484|NCT00834106|Primary|Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events|A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure.|Up to approximately 90 months|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
1452485|NCT00834106|Primary|Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an AE.|Up to 6 months|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
1452486|NCT00834106|Primary|Base Study: Percentage of Participants With One or More Systemic Adverse Events|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an AE.|Up to 15 days after any vaccination|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
1452487|NCT00834106|Primary|Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination.|Up to 15 days after any vaccination|All vaccinated participants with safety follow-up|||Percentage of participants|||Number
1452539|NCT00833924|Primary|Patients With Major Adverse Events (MAE)|MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.|30-day|1 patient experienced a re-intubation, which was adjudicated by the CEC as not related to AAA repair (related to a pre-existing condition).|||participants|||Number
1452488|NCT00834106|Primary|Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis)|The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block.|Up to Month 78|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 16 and 18.|||Cases per 100 person-years of follow-up|person-years||Number
1452489|NCT00834106|Primary|Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis)|The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.|From Day 1 until >=17 cases accumulate, up to Month 30|The population analyzed included participants 20 to 26 years old at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
1452490|NCT00834106|Primary|Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis)|The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block.|From Day 1 until >=25 cases accumulate, up to Month 30|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18.|||Cases per 100 person-years of follow-up|person-years||Number
1452491|NCT00834080|Primary|Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.|A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).|2 years (Baseline to end of study)|The Safety Population, defined as all subjects who received at least 1 dose (injection) of study drug, was used for presentation and analysis of both safety and efficacy data.|||participants|||Number
1452492|NCT00834067|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexiprilat.|Informational comparison of AUC0-inf values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452493|NCT00834067|Secondary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexiprilat.|Informational comparison of AUC0-t values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452494|NCT00834067|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexiprilat.|Informational comparison of Cmax values for the metabolite Moexiprilat.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452495|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Hydrochlorothiazide.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452496|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Hydrochlorothiazide.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452497|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Hydrochlorothiazide.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452498|NCT00834067|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) of Moexipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452499|NCT00834067|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) of Moexipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1452500|NCT00834067|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma) of Moexipril.|Bioequivalence based on Cmax.|Blood samples collected over a 192 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1452501|NCT00834041|Primary|Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.|||mL/h/kg||Standard Deviation|Mean
1452541|NCT00833898|Secondary|Plasma Inflammatory Marker Tumor Necrosis Factor (TNF)|Inflammatory markers increase in association with stress. TNF is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
1452502|NCT00834041|Primary|Area Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.|||h*ng/mL||Standard Deviation|Mean
1452503|NCT00834041|Secondary|Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients|Blood pressure (BP) measurements were made with a mercury sphygmomanometer or an automated blood pressure measuring device. Sitting BP was measured 3 times at 2-3 minute intervals after the patient had been sitting for 5 minutes. Means of the 3 measurements were calculated. A negative change in BP indicates lowered BP.|Baseline to end of treatment (Day 9)|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients.|||mmHg||Standard Deviation|Mean
1452504|NCT00834041|Secondary|Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9|Blood samples (2 mL) for pharmacodynamics evaluation of plasma renin activity were drawn pre-dose and at 2 and 10 hours following the dose of study medication on Day 1 and at pre-dose and at 2, 10, and 24 hours post-dose on Day 8-9.|Baseline to 2 and 10 hours post-dose on Day 1; pre-dose, 2, 10, and 24 hours post-dose on Day 8-9|Full Analysis Set (FAS): All randomized patients, excluding mis-randomized patients. Data was not available for all patients at all time points. For each time point, n = the number of subjects for whom data was available for each treatment group.|||ng/mL/h||Standard Deviation|Mean
1452505|NCT00834041|Primary|Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients|Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.|Day 1 and Day 8|Pharmacokinetic population: All patients who had evaluable aliskiren concentration data.|||ng/ml||Standard Deviation|Mean
1452506|NCT00833989|Secondary|Serum Levels of the S100β Protein|The serum sample for S100β collected on Day 1 (predose, 1, 6, 12 and 24 hour) and Day 5 and was analyzed for levels. Serum levels of S100β protein were recorded as log transformed values therefore the negative values are reported.|Day 1 (Pre-dose, Post dose 1, 6, 24 hour), Day 5|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||log (ug per liter)||Standard Deviation|Mean
1452507|NCT00833989|Secondary|Mean Change in Transcranial Magnetic Stimulations (TMS) Evaluated by Peak to Peak MEP by % Stimulation Level|TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motorneurons. Motor threshold was recorded as the lowest stimulus intensity (in percent) eliciting motor evoked potentials (MEPs). Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post -randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Percent change in stimulation||Standard Deviation|Mean
1452508|NCT00833989|Secondary|Mean Geriatric Depression Scale (GDS)|The short form GDS is a measure of depression developed specifically for use in elderly population and is sensitive and valid in the stroke population. The GDS was a participant-completed, 15 item questionnaire where each question referenced how the participant felt over the past week. Each question was answered with either a ‘yes’ or ‘no’ response. Of the 15 questions, 10 of them indicate depression when answered ‘yes’ (questions 2-4, 6, 8-10, 12, 14-15) and 5 indicate depression when answered ‘no’ (questions 1, 5, 7, 11, 13). Each question received a score of 1 point when the response was indicative of depression. Total score ranged from 0 to 15. the total score ranged from 0-15, where 0 implies no symptoms and higher score implies more severity of symptoms.|Day 5 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1452509|NCT00833989|Secondary|Mean Total Montreal Cognitive Assessment (MoCA) Score|MoCA was an examiner-administered, screening instrument with good validity, reliability, sensitivity and specificity for mild cognitive dysfunction. The MoCA had been studied in stroke participants and was recommended as a tool to monitor and measure cognitive changes post stroke as part of the 2006 National Institute of Neurological Disorders and Stroke – Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards. The MoCA assesses eight cognitive domains of visuospatial skills, executive function, language, attention, concentration, working memory, memory, and orientation. Participants were asked to complete 14 activities which the examiner scored according to the standardized scoring instructions. While there was no set time limit imposed on a participant. The total MoCA score ranges from 0-30, where 0= worsening and 30 reflects normal cognitive function.|Day 5 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1452510|NCT00833989|Secondary|Mean Barthel Total Score|The Barthel was a staff-assessed, 10 item activities of daily living index that evaluated feeding, grooming, dressing, excretion (bowels, bladder and toilet skills), bathing, and mobility (transfers, walking, stairs). The total Barthel score ranged from either 0-20 or 0-100 depending on which scoring algorithm was used where 0= unable or dependent and 20 or 100= independent to perform daily activities. For this study, the 100 point scoring algorithm was used. The Barthel takes approximately 5-10 minutes to complete with the participant.|Day 30 and 90|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1452903|NCT00831181|Secondary|Local Regional Control|subjects were followed for median of 22 months post-surgery|median follow-up 22 months post-TME|Out of the 27 patients enrolled, a total 23 underwent TME and were assessed for local regional control.|||patient|||Number
1452511|NCT00833989|Secondary|Change From Baseline of National Institutes of Health Stroke Scale (NIHSS)|The NIHSS is a staff-assessed, 15 item, standardized, disease-specific, deficit scale which measures neurological impairment and is used to quantify participant status by measuring the severity of the stroke. The total NIHSS score ranged from 0 (No impairment) to 42 (severe impairment). Approximately 15 minutes were needed to complete the NIHSS. The NIHSS will be collected as part of the eligibility requirements to exclude participants who have a deficit that is either too mild or too severe. Only NIHSS certified study personnel recorded the NIHSS. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 10, 30 and 90|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1452512|NCT00833989|Secondary|Number of Participants With Modified Rankin Scale (mRS)|The mRS was a 6 point scale that measured participant handicap by evaluating limitations in activity and changes in lifestyle. The mRS was staff-assessed and scored from 0=no symptoms at all, 1=no significant disability, 2=slight disability, 3=moderate disability, 4=moderate severe disability, 5=severe disability (severe disability, bedridden, incontinent and requiring constant nursing care and attention). The structured interview was used to administer the mRS. The mRS took approximately 15 minutes to complete when using the structured interview. Number of participants with mRS were reported as per the category of the score.|Day 30 and 90|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1452513|NCT00833989|Secondary|Mean Change in Grip Strength on Affected Side|Grip strength is an objective measure of arm motor recovery in stroke participants and correlate with functional status and predict recovery. Grip strength was evaluated by a hand grip dynamometer. Three replicate trials was collected for both the impaired and normal hand, starting with the normal hand. Each trial was separated by a resting period of approximately 15-30 seconds. Participants was instructed to squeeze as hard as possible while using a standardized position of grip and the resulting dynamometer reading (in kg) was recorded. The grip strength measures was conducted within approximately 5 minutes. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Kg||Standard Deviation|Mean
1452514|NCT00833989|Secondary|Mean Change in Total Box and Blocks Transferred on Affected Side|The Box and Blocks test is an objective, gross manual dexterity test that is reliable and valid in individuals with upper limb impairments. Box and Blocks was a staff-assessed, participant completed test that required the participant to move small wooden blocks from one side of a partitioned box to the other. The score was determined by the number of blocks transferred within a 60 second time period. More number of blocks transferred as compared to Baseline indicated improvement. Both the impaired and normal limbs were tested, starting with the normal limb. The number of blocks transferred were recorded. Baseline assessments were recorded at Day 1 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 1), Day 30, 60, 90 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Blocks||Standard Deviation|Mean
1452515|NCT00833989|Secondary|Mean Change in Total Fugl-Meyer Motor (FM) Assessment|The FM assessment is a staff-assessed, disease specific, quantitative measure of impairment that is used to assess recovery of sensorimotor function post stroke. The FM is designed to assess the domains of motor function, balance, sensation and joint function. For this study, only the motor function domain was assessed. The motor domain scale takes approximately 30 minutes to complete and evaluates both the upper and lower extremities by direct observation of the participant’s performance of 50 items that measure movement, coordination, and reflex action. Each item was scored from 0-2 for a minimum total score of 0 (hemiplegia) and a maximum total score of 100 (normal motor performance). Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30 and 112|All subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
1452516|NCT00833989|Secondary|Mean Change in Berg Balance Scale (BBS) Total Score|BBS is a performance based measure of balance. It is reliable, valid and responsive to change in the stroke population. BBS is a staff-assessed measure that requires the participant to perform 14 activities that evaluate ability to maintain balance. The BBS typically takes 10-15minute to complete. Participants were not allowed to use assistive devices while performing the activities. Each activity was evaluated by direct observation of the participant’s performance and was scored on a 5-point ordinal scale (0-4) where a score of 0 represents inability to perform the activity and a score of 4 represents independence in the activity. The minimum total score on the BBS was 0 and maximum was 56. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Score on Scale||Standard Deviation|Mean
1452540|NCT00833911|Primary|Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation|Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population|6 months and 12 months|"All patients having taken 1 dose of 300 mg Tramadol HCl OAD at a minimum are being assessed for adverse event occurence for up to 12 months.~6-months safety: patients who completed at least 175 days on treatment.~12-months safety: patients who completed at least 350 days on treatment."|||participants|||Number
1453381|NCT00827827|Primary|Change in Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
1452517|NCT00833989|Secondary|Mean Change in Mean Gait Velocity|Gait velocity is an objective, quantitative, reliable, valid and sensitive measure of lower extremity motor recovery in the stroke population. Changes in gait velocity correlates with physical functioning and quality of life. Gait velocity was assessed over a level, indoor 10 meter distance. The time (in seconds) it takes the participant to travel the 10 meter distance was recorded. Participants was asked to walk at their usual or normal pace and may use their normal assistive devices. Baseline assessments were recorded at Day 5 of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.|Baseline (Day 5), Day 30, 60, 90, 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Meters/second||Standard Deviation|Mean
1452518|NCT00833989|Secondary|Mean Clearance of GSK249320|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The clearance was calculated as Dose/ AUC(0-inf).|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||mL/hour/killogram (kg)||Standard Deviation|Mean
1452519|NCT00833989|Secondary|Mean Terminal Phase Rate Constant ( Lambda-Z)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||1/ hour||Standard Deviation|Mean
1452520|NCT00833989|Secondary|Mean Terminal Phase Half-life (t1/2)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. The apparent t1/2 obtained as the ratio of natural log (ln)^2/ lambda-Z, where lambda-Z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||Day||Standard Deviation|Mean
1452521|NCT00833989|Secondary|Mean Time of Occurrence of Cmax (Tmax) and Time of Last Observed Quantifiable Concentration (Tlast)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Tmax and tlast were determined directly from the raw concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetics population. Only those participants with data available for analysis were analyzed.|||hour||Standard Deviation|Mean
1452522|NCT00833989|Secondary|Mean Maximum Observed Concentration (Cmax) and Last Observed Quantifiable Concentration (Ct)|The pharmacokinetic parameters were calculated by standard non- compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. Cmax and Ct were determined directly from the raw concentration-time data.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetic population. Only those participants with data available for analysis were analyzed.|||microgram (ug) per mL||Standard Deviation|Mean
1452523|NCT00833989|Secondary|Mean Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC 0-inf) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis using Win Nonlin Pro 4.1. All calculations of non-compartmental parameters were based on actual sampling times. AUC0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC(0-inf) were calculated, where data permit, as the sum of area under the concentration-time curve over the dosing interval from 0 to Day 10 ±1 day (AUC0-10d) and C10d/z, where C10d is the observed plasma concentration at day 10 and z is the terminal phase rate constant calculated after the second dose.|Day 1 (Pre-dose, 1, 3, 6, 12 and 24 hour) and Day 10 (Pre-dose, 1, 3 hour)|Pharmacokinetic population comprised of participants from the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants with data available for analysis were analyzed.|||Hour*mg/millilitre (mL)||Standard Deviation|Mean
1452524|NCT00833989|Secondary|Number of Participants With Positive Antibodies to GSK249320|Presence of antibodies to GSK249320 were assessed in serum samples of participants using immunoelectro-chemiluminescent assay. Number of participants with positive antibodies to GSK249320 were reported. Only visits where the true positive antibody detection was observed were reported.|Day 1, 5, 10, 30, 60, 90 and 112|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1452525|NCT00833989|Primary|Number of Participants With Abnormal Hematological Parameters|The clinical chemistry parameters analyzed were white blood cell count, neutrophil count, hemoglobin, platelet count, lymphocytes. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal hematology findings at specified visit were reported.|Up to Day 112|All Subjects population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Participants|||Count of Participants
1452526|NCT00833989|Primary|Number of Participants With Abnormal Clinical Chemistry Parameters|The clinical chemistry parameters analyzed were albumin, calcium, creatinine, glucose, potassium, sodium, total CO2, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin. Only those parameters for which at least one abnormal value was reported are summarized. The number of participants with abnormal clinical chemistry findings at specified visit were reported.|Up to Day 112|All Subjects population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Participants|||Count of Participants
1452527|NCT00833989|Primary|Number of Participants With White Matter Changes and Demyelination Assessed by Magnetic Resonance Imaging (MRI)|Whole brain MRI scans were performed by appropriately qualified personnel at those specified visits (Day 1, 10 and 60 or at early withdrawal [if participant withdrew from study before Day 60 MRI]). Required pulse sequences of diffusion weighted imaging (DWI), T1, and T2 FLAIR was performed to measure lesion volume and to look for the presence of any new acute inflammatory lesions. The investigator or other medically qualified study team member evaluated the Day 10 and 60 scans for any new abnormalities or clinically significant worsening. Digital data for each MRI was sent to a central MRI laboratory for an over-read of the MRI scan and calculation of the lesion volume. Number of participants with change in white matter and demyelination on Day 10 compared to Day 1, Day 60 compared to Day 1 and Day 60 compared to Day 10 were reported.|Up to Day 60|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1452528|NCT00833989|Primary|Number of Participants With Nerve Conduction Testing (NCT) Values|NCT (electrode placement technique) of sensory and motor function was performed on the unaffected side (i.e., side that is not affected by the stroke) by appropriately qualified personnel at specified visits (Day 5 and 30 and at early withdrawal). Qualified technician performed the testing; however the same neurologist interpreted the NCT data within a single participant. Both upper and lower extremity nerves were tested and the data was recorded. Number of participants with normal and abnormal NCT data were reported.|Day 5 and 30 and at early withdrawal|All Subject population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1452529|NCT00833989|Primary|Number of Participants With Electrocardiogram (ECG) Values Outside Range of Potential Clinical Importance|Single 12-lead ECGs was obtained. The standard ECG criteria of potential clinical importance were uncorrected QT interval <300 and >600 milliseconds (msec), absolute QTc interval >500 msec, increase from Baseline QTc >60 msec, RR Interval <90 and >2000 msec, PR Interval <110 and >220 msec, QRS Interval <75 and >110 msec. The number of participants with potentially clinically significant ECG abnormality were reported.|Up to 112 days|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1452530|NCT00833989|Primary|Number of Participants With Vital Signs Changes of Potential Clinical Importance|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (SBP) (<85 and >200 millimeter of mercury [mmHg]), diastolic blood pressure (DBP) (<45 and >110 mmHg) and heart rate (HR) (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 112 days|All Subjects population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
1452531|NCT00833989|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 112 days|All Subjects population was defined as all participants who receive at least one dose of study medication.|||Participants|||Count of Participants
1452532|NCT00833976|Secondary|Tolerability of Omega-3 Fatty Acid Capsules (Lovaza)|At each of the visits, participants completed a questionnaire to determine tolerability of the omega-3 fatty acid capsules (Lovaza).|16 weeks|All participants who took at least one dose of the study medication were included in the analyzable population.|||Participants|||Count of Participants
1452533|NCT00833976|Secondary|Change in Total Cholesterol From Baseline to 16 Weeks||16 weeks|Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%|||mg/dL||Standard Deviation|Mean
1452534|NCT00833976|Primary|Change in Triglycerides From Baseline to 16 Weeks||16 weeks|Although only 14 participants completed the triall, 16 were included in the analyzable population. The 2 participants who are analyzable but not completers were lost to follow-up. They were included in the analysis since they still had 2 measurements time points. These 16 participants all had adherence values, as determined by pill count, of ≥75%|||mg/dL||Standard Deviation|Mean
1452535|NCT00833937|Primary|AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452536|NCT00833937|Primary|AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452537|NCT00833937|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452538|NCT00833924|Primary|Patients With Device Failures|"Device success at 12-month is defined as:~Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm."|12-month|There were 5 patients died, and 2 patients withdrew.|||participants|||Number
1452626|NCT00833690|Secondary|Serum Urate|From blood sample drawn prior to enrollment|Screening Visits, up to 45 days prior to Baseline Visit. Specifically, Screening Visit 1 occurred between day -45 and -4; Screening Visit 2 occurred between day -43 and -2.||||mg/dL||Standard Deviation|Mean
1452542|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 10 (IL-10)|Inflammatory markers increase in association with stress. IL-10 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
1452543|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 4 (IL-4)|Inflammatory markers increase in association with stress. IL-4 is an anti inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
1452544|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 6 (IL-6)|Inflammatory markers increase in association with stress. IL-6 is an inflammatory marker that will be assessed using high sensitivity IL-6 assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 11). Caregiver Intervention group: missing responses (n = 4).|||ln(pg/mL)||95% Confidence Interval|Mean
1452545|NCT00833898|Secondary|Plasma Inflammatory Marker Interleukin 1 Beta (IL-1 Beta)|Inflammatory markers increase in association with stress. IL-1 beta is an inflammatory marker that will be determined in plasma using multiplex array technology.|Baseline (prior to transplant) and 3 post transplant|Wilcoxon signed rank t-test|||pg/mL||Standard Deviation|Median
1452546|NCT00833898|Secondary|Plasma C-reactive Protein (CRP)|Plasma c-reactive (CRP) is an acute phase reactant that has been found to be predictive of cardiovascular disease. Is is also an inflammatory marker that will be assessed using high sensitivity CRP assays.|Baseline (prior to transplant) and 3 post transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 6).|||ln(mg/L)||95% Confidence Interval|Mean
1452547|NCT00833898|Secondary|Host Defense Assessed by Natural Killer (NK) Cell Cytotoxicity|The activity of natural killer (NK) cells is modified by psychosocial and behavioral states (Cacioppo et al., 1998; Irwin et al., 1991; Kiecolt-Glaser et al., 1991; Kiecolt-Glaser, 1999; Kiecolt-Glaser, McGuire, Robles, et al., 2002a; Kiecolt-Glaser, McGuire, Robles, et al., 2002b). Natural cytotoxicity will be determined toward K562 target cell lines as previously described (Laudenslager et al., 1998; Scanlan, et al., 1995). Percent lysis at each effector to target ratio will be found from the median value of each triplicate determination and from which the percent lysis/NK + cell will be determined for 20% lysis (lytic units/NK+ cell).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||ln(% Lysis/NK+ Cell)||95% Confidence Interval|Mean
1452548|NCT00833898|Secondary|Area Under the Curve for Salivary DHEA (AUCd)|The AUCd will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total DHEA released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).|||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
1452549|NCT00833898|Secondary|Area Under the Curve for Salivary Cortisol (AUCc)|The AUCc will be determined between awaking, 30 minutes after awaking, prior to lunch, and 10 hours after awaking from saliva samples collected using a special filter collection device applied in this study. This area will be an estimate of total cortisol released during this time period.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 14).|||ln[(nmol/L)*hour]||95% Confidence Interval|Mean
1452550|NCT00833898|Secondary|The Slope of the Diurnal Decline (SlopeD) in Salivary Dehydroepiandrosterone (DHEA)|The SlopeD has been noted to be affected by affective disorders such as depression. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and +10 hours after awaking to characterize the diurnal change in salivary DHEA.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 16). Caregiver Intervention group: missing responses (n = 15).|||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
1452551|NCT00833898|Secondary|The Slope of the Diurnal Decline in Salivary Cortisol (SlopeC)|The SlopeC has been noted to be affected by stressful experiences. From diurnal saliva collections at each phase we will fit curves between awake, before lunch, and 10 hours after awaking to characterize the diurnal change in salivary cortisol (SlopeC).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 12). Caregiver Intervention group: missing responses (n = 12).|||ln[(nmol/L)/hour]||95% Confidence Interval|Mean
1452552|NCT00833898|Secondary|Stress as Measured by the Impact of Events Scale (IES)|The Impact of Events Scale (IES), a widely accepted measure for evaluating intrusive thoughts regarding an event or situation. The scale consists of 15 items (7 measuring intrusive thoughts and 8 measuring avoidance) scored on a 5-point Likert Scale. Minimum score (best value)=0. Maximum score (worst value)=75. Scores over 20 indicate significant levels of PTS-like symptoms. The IES is anchored to the caregiving experience.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).|||units on a scale||95% Confidence Interval|Mean
1452553|NCT00833898|Secondary|Physical Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36P)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).|||units on a scale||95% Confidence Interval|Mean
1452565|NCT00833859|Primary|Number of Participants With Resectability|The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
1452554|NCT00833898|Secondary|Mental Component Summary Via the Short-Form 36-Item Health Survey Version 2.0 (SF-36M)|The Short-Form 36-Item Health Survey Version 2.0 (SF-36) is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Role emotional, social functioning and mental health contribute to mental component; as well as the social functioning, vitality, and general health. Scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 4).|||units on a scale||95% Confidence Interval|Mean
1452555|NCT00833898|Secondary|Sleep as Assessed by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score|The Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale to measure quality of sleep via questions regarding sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, where scores greater than 5 indicate poor sleep quality.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
1452556|NCT00833898|Secondary|Stress as Measured by Caregiver Burden Using the Caregiver Reaction Assessment (CRA)|The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale refers to the caregiver. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
1452557|NCT00833898|Secondary|Total Mood Disturbance (TMD) Score Using the Profile of Mood States (POMS)|POMS stands for the Profile of Mood States. The POMS consists of 65 adjectives rated by subjects on a 5-point scale and six factors that derive from this scale are: 1) tension-anxiety, 2) depression-dejection, 3) anger-hostility, 4) fatigue-inertia, 5) vigor-activity and 6) Confusion-bewilderment. A Total Mood Disturbance (TMD) can be calculated by adding the scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the score for Vigour. The range for the Total Mood Disturbance (TMD) score is 0 – 200, with higher score indicating more mood disturbance.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
1452558|NCT00833898|Secondary|State Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI)|The State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety).|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 3). Caregiver Intervention group: missing responses (n = 1).|||units on a scale||95% Confidence Interval|Mean
1452559|NCT00833898|Secondary|Depression Measured by the Center for Epidemiological Studies Depression Scale (CESD)|The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report 20-item scale designed to measure current depressive symptoms. Scores range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 5). Caregiver Intervention group: missing responses (n = 2).|||units on a scale||95% Confidence Interval|Mean
1452560|NCT00833898|Primary|Physiological - Cortisol Awakening Response (CAR)|Saliva will be collected using SPIT booklets containing four separate filter papers corresponding to collection times separated by waxed paper. Subjects will be asked to moisten a filter paper 1) immediately after waking, 2) 30 min later, 3) before lunch and 4) 10 hours after waking. They will be asked to collect these samples on three days typical for their schedules at each phase of the. They will indicate the time of each collection. Filters will dry in the booklet. Saliva samples will be aggregated across the three sampling days at each study phase to better reflect the typical pattern for each subject (see Smyth et al, 1997). The change from awakening to 30 minutes in cortisol (CAR) will be characterized by the change between waking and 30 min.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 15). Caregiver Intervention group: missing responses (n = 15).|||ln(nmol/L)||95% Confidence Interval|Mean
1452561|NCT00833898|Primary|Behavioral - Stress Level as Measured by the Perceived Stress Scale (PSS)|The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.|Baseline (prior to transplant), 1 and 3 post transplant|Caregiver Control group missing responses (n = 4). Caregiver Intervention group: missing responses (n = 2).|||units on a scale||95% Confidence Interval|Mean
1452562|NCT00833859|Secondary|Number of Participants With Overall Survival|We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
1452563|NCT00833859|Secondary|Number of Participants With Objective Response|Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
1452564|NCT00833859|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).|Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.|6 months per patient|Data for this study was not collected because the study was abandoned after two enrollments due to funding being cancelled.||||||
1452566|NCT00833833|Primary|Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off|"Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
1452567|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off|"Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"ITT population.~Data collection is ongoing and future data results will be included as available."|||weeks||95% Confidence Interval|Median
1452568|NCT00833833|Secondary|Phase 2: Time to Response as of the 01 April 2011 Cut-off|"Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Responders (participants achieving CR or PR) from ITT population.~Data collection is ongoing and future data results will be included as available."|||weeks||Full Range|Median
1452569|NCT00833833|Secondary|Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off|"Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome."|up to 70 weeks|"Responders (participants with a complete response or partial response) from the ITT population.~Data collection is ongoing and future data results will be included as available."|||weeks||95% Confidence Interval|Median
1452570|NCT00833833|Secondary|Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off|"IRAC used EBMT criteria to assess myeloma response:~Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)~Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others~Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others~Stable Disease (SD)- not MR or progressive disease (PD)~Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other~Not Evaluable (NE).~Data collection is ongoing and future data results will be included as available."|up to 70 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
1452571|NCT00833833|Secondary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 70|"Safety population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
1452572|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off|"TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.~Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 126|"Safety population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
1452583|NCT00833794|Secondary|Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)|Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
1452573|NCT00833833|Secondary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off|"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available."|Up to week 104|"Safety population.~Data collection is ongoing and future data results will be included as available."|||percentage of participants|||Number
1452574|NCT00833833|Primary|Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off|"Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.~Data collection is ongoing and future data results will be included as available."|up to 67 weeks|"Intent to treat population.~Data collection is ongoing and future data results will be included as available."|||weeks||95% Confidence Interval|Median
1452575|NCT00833833|Primary|Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1|"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.~DLTs were defined as:~Grade 4 neutropenia or thrombocytopenia~Febrile neutropenia~Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment~Serum transaminase > 20 * upper limit of normal (ULN)~Serum transaminase > 5 * ULN for >= 7 days~Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event"|Up to Day 28 (Cycle 1)|Safety population|||participants|||Number
1452576|NCT00833794|Secondary|Discontinuation Due to Adverse Events|The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
1452577|NCT00833794|Secondary|Discontinuation Due to Lack of Efficacy|The number of patients who discontinued due to lack of efficacy was reported.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
1452578|NCT00833794|Secondary|Time to Response|Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||days||95% Confidence Interval|Median
1452579|NCT00833794|Secondary|Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|week 12|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
1452580|NCT00833794|Secondary|Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)|This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||participants|||Number
1452581|NCT00833794|Secondary|WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
1452582|NCT00833794|Secondary|WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)|Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
1452584|NCT00833794|Secondary|Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain|6 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
1452585|NCT00833794|Primary|Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)|The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.|12 weeks|Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.|||Points on a scale||Standard Deviation|Mean
1452586|NCT00833781|Secondary|IL2 and IFN Gamma Production||Baseline to week 14|Results from these assays were too variable to be interpretable.||||||
1452587|NCT00833781|Primary|Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef|Immunogenicity was measure by interferon gamma enzyme-linked immunospot (ELISPOT) assay. The number of spot forming cells per million PBMC was determined at each time point. The fold ratio represents week 14 value divided by value at baseline.|Baseline and 14 weeks||||fold ratio||Full Range|Median
1452588|NCT00833781|Secondary|T Cell Proliferation||Baseline to week 14||||fold change||95% Confidence Interval|Mean
1452589|NCT00833781|Primary|Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)|Number of participants with grade 3 or 4 adverse events related to vaccination|After vaccination||||participants|||Number
1452590|NCT00833755|Primary|Change in Duration of Supra-threshold Pain Tolerance|"Using QST, we detected the duration (seconds) of tolerance to supra-threshold heat pain stimulation. In this test, subjects were asked to tolerate, as long as he or she could, heat stimulation preset at 47°C for a maximum of 60 seconds. They were given the computer mouse to stop the test if they reached their limit before 60 seconds. If they stopped the test before the 60 seconds, the time that they stopped it was recorded.~This test was repeated 3 times and an average duration was calculated. The duration could range from a minimum of 0 seconds to a maximum of 60 seconds."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.|||seconds||Standard Deviation|Mean
1452591|NCT00833755|Primary|Change in Temperature of Pain Tolerance|"Using QST, we measured the change in pain tolerance which was the maximum thermal stimulation intensity (in °C) tolerable. In this test, the subject was instructed to press the computer mouse to stop stimulation when the thermode reached the maximal tolerable temperature.~This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.|||Degrees Celsius||Standard Deviation|Mean
1452592|NCT00833755|Primary|Change in Temperature of Pain Threshold|"We measured the change in pain threshold using Quantitative Sensory Testing (QST). QST refers to a set of quantitative testing of individual responses to mechanical, thermal, and/or electrical stimulation. In this study, pain threshold was the thermal stimulation intensity (in°C) first perceived as painful. To measure this, a contact thermode was attached onto the dorsal surface of the forearm. By pressing a computer mouse button, each subject was able to stop stimulation when they first perceived a painful stimulation from the thermode as the temperature increased 1°C/s.~This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C."|Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1|Only subjects who experienced pain relief after the infusion were scheduled for visit 2. This is why the overall # of participants analyzed differs from the # of baseline participants.|||Degrees Celsius||Standard Deviation|Mean
1452593|NCT00833703|Primary|Number of Participants According to Bleeding Type/Etiology|For all reported bleeding events, the type and the etiology of the bleeding event were collected. Participants who experienced bleeding events during the 'on-treatment period' were counted by bleeding type and etiology.|Up to a maximum of 6 months|The analysis was performed on the same population as previously (i.e. ITT population).|||participants|||Number
1452594|NCT00833703|Secondary|Number of Participants With Shunt Thrombosis Requiring Intervention or Deaths|"Outcome events, shunt thrombosis requiring intervention or death, experienced during the study period were recorded.~Participants were counted excluding the events that occured after the participant's protocol study end (occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first)."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.|||participants|||Number
1452595|NCT00833703|Primary|Number of Participants With Bleeding Events|"All bleeding events experienced during the study period were collected as for any Adverse Event.~The 'on-treatment' period was defined as the period from inclusion in the extension study up to 28 days after treatment discontinuation, and participants who experienced bleeding events during that period were counted."|Up to a maximum of 6 months|The analysis was performed on the Intent-to-treat (ITT) population that consisted of all included participants. Participants were analyzed in the treatment arm allocated at randomization into the CLARINET study.|||participants|||Number
1452596|NCT00833690|Secondary|Change in Serum Urate|Change from Last Visit on Study Drug|Safety Visit (SV) from End of Study Drug Visit (ESD); i.e., between +263 and +760 days)||||mg/dL||Standard Deviation|Mean
1452597|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Safety Visit (SV) from Baseline (i.e., between -45 days and +760 days [+1 month after ESD Visit])||||mg/dL||Standard Deviation|Mean
1452598|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 12 from Baseline (i.e., between -45 days and +24 months)||||mg/dL||Standard Deviation|Mean
1452599|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 11 from Baseline (i.e., between -45 days and +21 months)||||mg/dL||Standard Deviation|Mean
1452600|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 10 from Baseline (i.e., between -45 days and +18 months)||||mg/dL||Standard Deviation|Mean
1452601|NCT00833690|Secondary|Change in Serum Urate|Change from an Average of Baseline and Screening Visits|Visit 09 from Baseline (i.e., between -45 days and +15 months)||||mg/dL||Standard Deviation|Mean
1452627|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Males)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks||||percentage of baseline serum urate||Standard Deviation|Mean
1452628|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (Females)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks||||percentage of baseline serum urate||Standard Deviation|Mean
1452629|NCT00833690|Secondary|CSF Urate as a Proportion of Baseline Serum Urate (All Patients)|Although CSF urate was not measured at baseline, the change of CSF urate from baseline may be indirectly estimated by the ratio of CSF urate (at the 12 week visit when a lumbar puncture was performed) to the serum urate measured in the same subject at baseline. Baseline serum urate and CSF urate concentrations are directly correlated with one another (i.e., individuals with higher serum urate concentrations tend to have higher CSF urate concentrations) even though the concentration of urate in CSF is typically ~10% of that in serum. The ratio of CSF urate to baseline serum urate can be expressed as the percentage of the value of urate concentration measured in serum at baseline that is measured in CSF (at week 12).|12 weeks||||percentage of baseline serum urate||Standard Deviation|Mean
1452630|NCT00833690|Secondary|CSF Urate (Males)||12 weeks||||mcg/dL||Standard Deviation|Mean
1452631|NCT00833690|Secondary|CSF Urate (Females)||12 weeks||||mcg/dL||Standard Deviation|Mean
1452632|NCT00833690|Secondary|CSF Urate (All Patients)|Urate concentration in cerebrospinal fluid (CSF)|12 weeks||||mcg/dL||Standard Deviation|Mean
1452633|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to AEs, and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|24 months||||percentage of participants|||Number
1452634|NCT00833690|Primary|Tolerability|Defined as the extent to which assigned treatment could continue without prolonged dose reduction (>48 consecutive days or >73 cumulative days, which is 10% of total 2-year follow-up) due to adverse experiences (AEs), and was assessed after 6 and 24 months on study drug. Units of measure are percentage points (i.e., % of participants in the group).|6 months||||percentage of participants|||Number
1452635|NCT00833664|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452636|NCT00833664|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452637|NCT00833664|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452638|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who received tadalafil 2.5 mg in the double-blind study period and did not respond to treatment in that treatment period, who have at least 1 baseline observation and who took at least 1 dose of tadalafil 5 mg in the open-label period followed by at least 1 intercourse attempt.|||percentage successful attempts||Standard Deviation|Mean
1452639|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation, who took tadalafil 5 mg during the double-blind treatment period, and who took at least 1 dose of tadalafil 5 mg followed by at least 1 intercourse attempt during the open-label period.|||percentage successful attempts||Standard Deviation|Mean
1452659|NCT00833521|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452640|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14-day double-blind and 14-day open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage successful attempts||Standard Deviation|Mean
1452641|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period|"Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse?"|14 days double-blind and 14 days open-label|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage successful attempts||Standard Deviation|Mean
1452642|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts|"Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a yes response to the sexual encounter profile diary question #3: Did your erection last long enough for you to have successful intercourse? Data are presented as the proportion of intercourse attempts for which participants answered yes relative to the total number of intercourse attempts. Total number of attempts = TNA."|14 days during double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of total number of attempts|||Number
1452643|NCT00833638|Secondary|Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses|"Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a yes response to the sexual encounter profile diary question 3: Did your erection last long enough for you to have successful intercourse? Data are based on participants who responded yes. For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy."|4 days double-blind period|Included in the analysis were all subjects with successful intercourse within the first 4 days of treatment, who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||days||Standard Error|Median
1452644|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 5: Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
1452645|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 4: Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
1452646|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 3: Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
1452647|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 2: Were you able insert your penis into your partner's vagina? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
1452648|NCT00833638|Secondary|Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses|"Assessed was the mean change from baseline in the percentage of yes responses to the Sexual Encounter Profile Diary question number 1: Were you able to achieve at least some erection (some enlargement of the penis)? Data are presented as the mean percentage of participants who answered yes."|Baseline and 14 days double-blind period|Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||percentage of participants||Standard Error|Least Squares Mean
1452649|NCT00833638|Primary|Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3|Cumulative percentage of participants achieving successful intercourse, as measured by “yes” responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse.|4 days during double-blind period|Modified intent-to-treat population consisting of all participants who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.|||cumulative percentage of participants|||Number
1452650|NCT00833586|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma|Bioequivalence based on AUC0-t|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452651|NCT00833586|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma|Bioequivalence based on AUC0-inf|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452652|NCT00833586|Primary|Cmax - Maximum Observed Concentration - Terbinafine in Plasma|Bioequivalence based on Cmax|Blood samples collected over 144 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452653|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Per-protocol Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible.|Up to Day 63|"Per-protocol analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."|||Percentage of participants|||Number
1452654|NCT00833560|Secondary|Percentage of Participants With Complete Response + Partial Response in Relation to Cytogenetic Subgroups (Efficacy Set)|Response rate was defined as the percentage of participants with response of combined CR+PR according to the EBMT criteria. As per the EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein and no increase in size or number of lytic bone lesions; PR is defined as not all CR criteria and 50 percentage or more reduction in serum monoclonal paraprotein. Percentage of participants with complete or partial response that carried the indicated cytogenetic marker is reported. Same participant could count in more than one category due to multiple responses possible|Up to Day 63|"Efficacy analysis set. N (number of participants analyzed) signifies participants with complete or partial response. n signifies number of participants who were evaluable for each specified category (participants that carried the indicated cytogenetic marker)."|||Percentage of participants|||Number
1452655|NCT00833560|Secondary|Participants With Complete Response (CR) + Partial Response (PR) (Per-protocol Analysis Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Per-protocol analysis set: It includes the participants who completed the entire clinical study without major protocol violations.|||Participants|||Number
1452656|NCT00833560|Primary|Participants With Complete Response (CR) + Partial Response (PR) (Efficacy Set)|CR and PR are defined by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|Up to Day 63|Efficacy analysis set: Participants of the safety analysis set (who received bortezomib at least once independently of accordance to the protocol) who had an evaluable investigator based assessment of success of therapy at the end of study visit (ie, assessment by local investigator as CR, PR, minimal response, stable disease, progressive disease).|||Participants|||Number
1452657|NCT00833547|Primary|Sleep Spindle Density During Stage 2 Sleep as Measured by Polysomnography|2 baseline nights (Days 1 &2); 2 experimental nights (Days 3 &4)|during two nights in an inpatient Clinical Research Center||||spindles per minute during Stage 2 sleep||Standard Deviation|Mean
1452658|NCT00833547|Primary|Overnight Change on Finger Tapping Task|"The finger tapping task involves pressing four numerically labeled keys on a standard computer keyboard with the fingers of the left hand, repeating a five element sequence (4-1-3-2-4) as quickly and accurately as possible for 30s. During both training and test sessions, participants alternated tapping and resting for 30s for a total of 12 tapping trials. The measure was the number of correct sequences per trial. Overnight change was the percent change in correct sequences from the last three training trials to the first three test trials the following morning."|Train on Day 3 and Test on Day 4 of study (experimental nights)||||percent change||Standard Deviation|Mean
1452660|NCT00833521|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1452661|NCT00833521|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 24 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1452662|NCT00833482|Secondary|Number of Participants With Abnormalities in Vital Signs||Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
1452663|NCT00833482|Secondary|Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator|volt=voltage; LVH=left ventricular hypertrophy|Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
1452664|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If <.85*LLN or >1.15*ULN or ULN or if preRX<LLN, use <0.85*preRX or >ULN; if preRX>ULN, use >1.15*preRX or <LLN. Lymphocytes, relative: If <0.85*LLN or >1.15*ULN, or if preRX <LLN, use <0.85*preRX or >ULN; if preRX >ULN, use >1.15*preRX or <LLN. Blood, urine: If >= 2+, or if preRX >=1+, use >=2*preRX. White blood cells, urine: If >=2+, or if preRX >=2+, use >=4+. Red blood cells, urine: If >=2+ or if preRX >=2+, use >=4+. Not all categories were evaluated for each arm.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
1452665|NCT00833482|Secondary|Number of Participants With Marked Abnormalities in Serum Chemistry Test Results|LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If >1.25*ULN, or if preRX>ULN, use >1.25*preRX. Total and direct bilirubin: If >1.1*ULN or if preRX>ULN, use >1.25*preRX. Creatinine: If >1.33*preRX. Serum glucose, fasting: If preRX<LLN, use <.8*preRX or >ULN; if preRX>ULN, use >2*preRX or <LLN. Creatinine kinase: If >1.5*ULN or preRX>ULN, use >1.5*or preRX. Lactose dehydrogenase: If >1.25*ULN or preRX>ULN, use >1.5*preRX.|Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|All participants who received study drug.|||Participants|||Number
1452666|NCT00833482|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Days 1 to 31 (discharge), continuously|All participants who received study drug.|||Participants|||Number
1452667|NCT00833482|Secondary|AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1452668|NCT00833482|Primary|AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
1452669|NCT00833482|Primary|Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1452670|NCT00833482|Primary|Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||Hours||Full Range|Median
1452671|NCT00833482|Secondary|Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||Hours||Full Range|Median
1452672|NCT00833482|Secondary|Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1452673|NCT00833482|Primary|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1452674|NCT00833482|Primary|Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants|EM=extensive metabolizers, or participants with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||Hours||Full Range|Median
1452675|NCT00833482|Primary|Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM)|EM participants are those with functional CYP2C19 alleles.|Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|All participants who were healthy, who had functional CYP2C19 alleles, who received any study drug, and who had concentration-time data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1452676|NCT00833469|Secondary|Change in Beck Anxiety Inventory (BAI)|Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.|||units on a scale||Standard Deviation|Mean
1452677|NCT00833469|Secondary|Change in Edinburgh Postnatal Depression Scale (EPDS)|The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.|||units on a scale||Standard Deviation|Mean
1452678|NCT00833469|Primary|Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).|8 weeks|Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.|||units on a scale||Standard Deviation|Mean
1452679|NCT00833443|Post-Hoc|End of Treatment Methamphetamine Abstinence||12 weeks||||participants|||Number
1452680|NCT00833443|Secondary|Treatment Retention||12 weeks||||days||Standard Deviation|Mean
1452681|NCT00833443|Primary|End of Treatment Methamphetamine Abstinence|Methamphetamine abstinence confirmed via urine drug screens during the final two weeks of treatment (weeks 11 and 12)|12 weeks||||participants|||Number
1452682|NCT00833443|Primary|Treatment Effectiveness Score|The mean number of methamphetamine-free urine drug screens provided by participants in each group (range 0-36)|12 weeks||||urine drug screens||Standard Deviation|Mean
1452683|NCT00833417|Secondary|Percentage of Patients With Absence of Residual Basal Cell Carcinoma (BCC) in Patients With Locally Advanced BCC|In patients with locally advanced BCC, the histopathological effect of vismodegib was determined in tissue biopsies obtained at baseline and following vismodegib treatment. Reported are the percentage of patients with pathology confirmed BCC in baseline biopsy who had an absence of residual BCC post-baseline as assessed by an independent pathological review.|From baseline through end of the study, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma. Only locally advanced BCC patients with available post-baseline biopsy assessed by an independent pathologist were included in the analysis.|||Percentage of participants|||Number
1452684|NCT00833417|Secondary|Change From Baseline in Short Form 36 (SF-36) Health Survey Scores|The SF-36 Health Survey (Version 2) uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role−Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role−Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.|Baseline, Week 12, Week 24, and at the end of the study or early termination visit, up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Units on a scale||95% Confidence Interval|Mean
1452685|NCT00833417|Secondary|Overall Survival|Overall survival was defined as the time from the initial dose of vismodegib until death from any cause.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Months||95% Confidence Interval|Median
1452686|NCT00833417|Secondary|Progression-free Survival (PFS) Determined by the Independent Review Facility|PFS was defined as the time from start of treatment to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Months||95% Confidence Interval|Median
1452701|NCT00833053|Secondary|Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28|The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
1452687|NCT00833417|Secondary|Duration of Objective Response (OR) Determined by the Independent Review Facility|Duration of OR was defined as the time from the initial CR or PR to the earliest documented disease progression (PD) or death. Metastatic BCC - PD: ≥ 20% increased sum of the longest diameter (SLD) of targets from nadir, or 1 or more new lesions. Locally advanced BCC - PD: any of: (1) ≥ 20% increased SLD from nadir (radiography or externally visible dimension); (2) new ulceration; (3) new lesions (radiography or physical exam); (4) progression of non-target lesions by radiography.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Months||95% Confidence Interval|Median
1452688|NCT00833417|Primary|Objective Response (OR) Determined by the Independent Review Facility|OR=complete (CR) or partial response (PR). Metastatic-CR:Disappearance of all targets. PR:≥30% decreased sum of longest diameter (SLD) of targets compared to baseline (B). Locally advanced-Response=No progressive disease (PD) and ≥30% decreased SLD from baseline (radiography [R]) or ≥30% decreased SLD from B (externally visible dimension [EVD]) or completely resolved ulceration. CR:Response with no residual BCC on tumor biopsy (otherwise response was PR). PD:Any of ≥20% increased SLD from nadir (R or EVD), new ulceration, new lesions (R or physical exam) or non-target lesion progression by R.|From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks|Efficacy-evaluable population: All treated patients for whom the independent pathologist’s interpretation of archival tissue or baseline biopsies was consistent with basal cell carcinoma.|||Percentage of participants||95% Confidence Interval|Number
1452689|NCT00833365|Secondary|Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration||1 and 6 hours|Due to early termination of the study, labs were not analyzed.||||||
1452690|NCT00833365|Primary|Number of PDA Closures Related to Treatment With Ibuprofen|Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.|Within 48 hrs of ibuprofen round|Premature infants born at 23+3 weeks to 29+4 weeks with positive patent ductus arteriosus on cardiac echogram were randomized to early or late treatment with ibuprofen. 2 babies which had been originally randomized to the late treatment arm never got ibuprofen and are not included in analysis.|||closures related to treatment|||Number
1452691|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.|Baseline to 12 weeks of treatment|Safety analysis set.|||participants|||Number
1452692|NCT00833248|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|Safety analysis set.|||participants|||Number
1452693|NCT00833248|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||scores on a scale||Standard Deviation|Mean
1452694|NCT00833248|Secondary|Change From Baseline in Serum Oestradiol Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||nanogram per deciliter||Full Range|Median
1452695|NCT00833248|Secondary|Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||nanograms per milliliter||Full Range|Median
1452696|NCT00833248|Secondary|Change From Baseline in Serum Testosterone Levels During the Study||After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||nanograms per milliliter||Full Range|Median
1452697|NCT00833248|Secondary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4, 8, and 12 weeks compared to Baseline|FAS, OC.|||scores on a scale||Standard Deviation|Mean
1452698|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, OC.|||milliliter||Standard Deviation|Mean
1452699|NCT00833248|Primary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)|TRUS is a method of measuring the size of the prostate.|After treatment of 12 weeks compared to Baseline|FAS, Observed Case (OC) i.e. only participants with a reported value were included in the analysis.|||milliliter||Standard Deviation|Mean
1452700|NCT00833092|Primary|Global Pittsburgh Sleep Quality Index|Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.|9 weeks|Data from 4 participants (3 on sugar pill, 1 on magnesium) were omitted from statistical analysis because of protocol violations discovered near end of study.|||score on a scale||Standard Error|Mean
1452904|NCT00831181|Secondary|Complete Resectability Rates|Complete resectability rates assessed by circumferential margin.|Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.|Out of the 27 patients enrolled, a total 23 underwent TME.|||patient|||Number
1452702|NCT00833053|Secondary|Dermatology Life Quality Index (DLQI) at Week 28|The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.|Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
1452703|NCT00833053|Secondary|Change From Baseline in Mean Participant Raw PASI Scores at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
1452704|NCT00833053|Secondary|Number of Participants With A PASI-100 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
1452705|NCT00833053|Secondary|Number of Participants With A PASI-90 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
1452706|NCT00833053|Secondary|Number of Participants With A PASI-50 Response at Week 28|The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.|Baseline, Week 28|The study was terminated early with only 15% subjects of the original planned size. Accordingly, secondary efficacy analyses were cancelled due to such a small subject population.||||||
1452707|NCT00833053|Primary|Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28|The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0–4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.|Baseline, Week 28||||Participants|||Number
1452708|NCT00833040|Primary|Time-weighted SPID30|time-weighted SPID30 is the sum of the pain intensity difference (PID) over the 30 minute time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is recorded at pre-dose, 10, 15, 30, 45, and 60 minutes post-dose. The pain score at each assessment time through 30 minutes is subtracted from the baseline pain score to provide the total sum score or SPID30. A higher SPID30 is better and indicates a reduction in pain intensity compared to the baseline score.|30 minutes after dosing|Intent to treat population defined as all patients who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
1452709|NCT00833027|Secondary|Change From Baseline in HbA1c at Week 12|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 12|Includes all patients who received at least one dose of study medication and have a Week 12 measure.|||Percent||Standard Deviation|Mean
1452710|NCT00833027|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent|Baseline and Week 24|Includes all patients who received at least one dose of study medication and have a Week 24 measure.|||Percent||Standard Deviation|Mean
1452711|NCT00832975|Secondary|Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure||24 months||||Patients|||Number
1452712|NCT00832975|Primary|Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec)|Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec|24 months|157 patients were analyzed: 118 completed 2 years of Follow Up (FU) and 39 patients were terminated before completing it|||Episodes|||Number
1452713|NCT00832871|Other Pre-specified|Overall Survival|The time from patient entry into the protocol to death by any cause.|5 years||||Months||Standard Deviation|Median
1452714|NCT00832871|Secondary|Toxicity Associated With Adrenal Insufficiency|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts the following events of interest, which are related to possible adrenal insufficiency: nausea, vomiting, lethargy, dizziness, fatigue, anorexia, and skin rash. Any grade of these events that are self-reported by patients as well as events identified by physician assessment (e.g. physical exam) will be included.|Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest)|All patients received at least one dose of study medication and are included in this analysis.|||percentage of participants|||Number
1452730|NCT00832767|Secondary|Confidence Scale Change From Baseline|"The Confidence Scale consists of Questions 9 and 10 on the Body Image Questionnaire. One question is before procedure and another is after procedure. The Patients were asked to rate their overall confidence before (baseline) and after the procedure. The scores for before/after procedure range from 1 to 10 with 1 being “not very confident” and 10 being “very confident”. The score difference from the before/after treatment is compared between the two procedures (4PLC and SILS™)~Here, a positive score indicates that patient confidence has increased."|Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year|The number analyzed includes participants who completed questions 9 & 10 on the Body Image Questionnaire. Mean Change from Baseline (Pre-Op).|||units on a scale||Standard Deviation|Mean
1452715|NCT00832871|Primary|Duration of Response|The time from the date of response (not the beginning of treatment unless there is stable disease) to disease progression. Response and progression are evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|5 years|Only one patient achieved stable disease. This patient's duration of response could therefore be reported. The other three patients progressed on treatment.|||days||Full Range|Median
1452716|NCT00832819|Secondary|To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.|Refer safety section for safety analysis|Throughout the study until 30 days after last dose|||||||
1452717|NCT00832819|Secondary|Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.||At various time points until Day 22 of Cycle 1|||||||
1452718|NCT00832819|Primary|Maximum Tolerated Dose (MTD)|Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.|7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1|DLTs were analyzed on the Safety Analysis Set; however subjects with 75% or less treatment compliance for E7080 in Cycle 1 or those who discontinued the study and had no confirmed data on tolerability up to Cycle 1 Day 22 were excluded from this analysis.|||mg BID|||Number
1452719|NCT00832819|Secondary|Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.||At Screening, on Day 22 of every even cycle, and at discontinuation|||||||
1452720|NCT00832780|Secondary|Clinical Benefit Rate (CBR)|CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD).|2 years||||Participants|||Count of Participants
1452721|NCT00832780|Secondary|Progression Free Survival (PFS)|The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years||||Participants|||Count of Participants
1452722|NCT00832780|Secondary|Overall Survival (OS)|The time from treatment initiation to death by any cause|1 year||||Participants|||Count of Participants
1452723|NCT00832780|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported.|2 years||||participants|||Number
1452724|NCT00832780|Primary|Response Rate (RR)|RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR)|2 years||||Participants|||Count of Participants
1452725|NCT00832767|Secondary|Time to Cannulization|Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.|Day 0||||minutes||Standard Deviation|Mean
1452726|NCT00832767|Secondary|Mental Quality of Life|"SF8 scale was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.~The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL."|Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)|The number includes participants who completed the SF8 questionnaire.|||units on a scale||Standard Deviation|Mean
1452727|NCT00832767|Secondary|Physical Quality of Life|"SF8 questionnaire was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.~The raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL."|Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)|Number includes all participants who completed SF8 Quality of Life Questionnaire.|||units on a scale||Standard Deviation|Mean
1452728|NCT00832767|Secondary|Modified Hollander|Surgeons were asked to answer 6 questions regarding the appearance of their subjects’ scars. Each patient’s score was summed for a total score 0 to 6 with 0 being the best.|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes all participants where Modified Hollander Score was completed.|||units on a scale||Standard Deviation|Mean
1452729|NCT00832767|Secondary|Normalized Scar Scores|"Photo Series Questionnaire (PSQ). All subjects were asked to score their own scar (Question 1), then rate 2 standardized photos (one of 4PLC scars and one of a SILS™ scar) (Questions 2 and 3, respectively) and finally rate their own scar again after viewing the photos (Question 4). All scars were rated on a scale from 1 to 10 with 10 being the best.~Normalized scores were analyzed for the photo questionnaire. In order to calculate the normalized score, each patient's score of the 4PLC photo was subtracted from their score of their own scar before viewing the photos. the median values were then used to calculate statistical significance.~Normalized Scores of Own Scar are reported below:~Question 1 - Question 2 (Q1 - Q2) Question 4 - Question 2 (Q4 - Q2)~In order to calculate the normalized score for the subject's own scar, Q2 was used as baseline score since Q2 was the score for the conventional procedure 4PLC."|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes all participants who completed the Photo Series Questionnaire.|||units on a scale||Standard Deviation|Mean
1452731|NCT00832767|Secondary|Cosmetic Scale|The Cosmetic Scale consists of Questions 6-8 on the Body Image Questionnaire. Here, patients were asked to answer questions regarding the cosmesis of their own scar (SILS™) or scars (4PLC). The first 2 questions were answered on a scale from 1 to 7 and Question 8 from 1 to 10, both with 1 being the worst. Therefore, a total score of 3-24 was calculated for each patient with 3 being the worst.|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes participants who completed the Cosmetic Scale|||units on a scale||Standard Deviation|Mean
1452732|NCT00832767|Secondary|Body Image Scale|The Body Image Scale consists of Questions 1-5 on the Body Image Questionnaire. Here, subjects were asked to answer each question on a scale from 1 to 4 with 1 being the best. Therefore, a total score of 5-20 was calculated for each patient with 5 being the best.|Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)|The number includes participants who completed the Body Image Questionnaire.|||units on a scale||Standard Deviation|Mean
1452733|NCT00832767|Secondary|Average Pain Experienced in the Last 24 Hours at Various Time Frames|Pain evaluation as determined by a 10-point pain intensity numerical rating scale (PI-NRS) ranging from 0 (no pain) to 10 (worst possible pain).|Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)|Number includes patients who completed pain evaluation questionnaire.|||units on a scale||Standard Deviation|Mean
1452734|NCT00832767|Primary|Estimated Blood Loss|Blood loss from surgical procedure in cc.|Day 0||||cc||Standard Deviation|Mean
1452735|NCT00832767|Primary|Operative Time|Duration of surgical procedure in minutes.|Day 0|One site did not collect the operative time for a patient in the SILS group|||minutes||Standard Deviation|Mean
1452736|NCT00832767|Primary|Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC|Feasibility and safety as determined by intraoperative and postoperative adverse events.|One year||||Participants|||Number
1452737|NCT00832650|Secondary|Mean Proportion of Bowel Movements With Satisfaction Per Day|The number of stools with satisfaction of “Yes” divided by the total number of stools passed on each notional day. Mean of 3 days.|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||mean proportion||Standard Deviation|Mean
1452738|NCT00832650|Secondary|Average Score of Ease of Passage During Defecation Per Day|Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||score on a scale||Standard Deviation|Mean
1452739|NCT00832650|Secondary|Mean Score of Stool Consistency Per Day|Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||score on a scale||Standard Deviation|Mean
1452740|NCT00832650|Secondary|Mean Number of Stools Per Day|Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.|Day 11 to 13|ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.|||stools||Standard Deviation|Mean
1452741|NCT00832650|Secondary|Time to Gastric Emptying|Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12: 2 hours, 4 hours|ITT included all randomized subjects. Imputation by overall mean for missing data.|||minutes||Standard Deviation|Mean
1452742|NCT00832650|Secondary|Colonic Filling at 6 Hours|A surrogate marker of small bowel transit time.|Day 12|ITT included all randomized subjects. Imputation by overall mean for missing data.|||percentage||Standard Deviation|Mean
1452743|NCT00832650|Secondary|Colonic Transit at 48 Hours|Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 14 (Day 12 48 hours post-meal)|ITT included all randomized subjects. Imputation by overall mean for missing data.|||counts||Standard Deviation|Mean
1452744|NCT00832650|Secondary|Proximal Colonic Emptying Time|Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.|Day 12 to 14|ITT included all randomized subjects. Imputation by overall mean for missing data.|||hours||Standard Deviation|Mean
1452745|NCT00832650|Primary|Colonic Transit at 24 Hours|Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC *1 + % TC *2 + % DC *3 + % RS *4 + % stool * 5 ) divided by 100.|Day 13 (Day 12 24 hours post-meal)|Intent to treat (ITT) included all randomized subjects. Imputation by overall mean for missing data.|||counts||Standard Deviation|Mean
1452746|NCT00832637|Secondary|Toxicity|Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events).|Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeks||||participants|||Number
1452747|NCT00832637|Secondary|Median Survival Time (MST)|Survival is defined as the time from treatment initiation to death by any cause|2 years||||weeks||95% Confidence Interval|Median
1452748|NCT00832637|Secondary|Time to Tumor Progression (TTP)|The time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years||||weeks||95% Confidence Interval|Median
1452749|NCT00832637|Secondary|Overall Response Rate|"Overall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks||||percentage of evaluable participants|||Number
1452750|NCT00832637|Primary|Tumor Control Rate|"Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment.~Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|24 weeks||||percentage of evaluable participants|||Number
1452751|NCT00832624|Primary|Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18|Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected.|Baseline and Week 18|The study was terminated early and no data were analyzed for this outcome.||||||
1452752|NCT00832598|Secondary|Explore if [18F]FACBC PET and [18F]FLT PET Imaging Can be Related to Molecular Markers (AKT, VEGFR, and Related Signaling/Biologic Changes by Immunohistochemistry and/or Analysis of Flash Frozen Tissue)||2 years|Data was not collected||||||
1452753|NCT00832598|Secondary|Compare [18F]FACBC PET & [18F]FLT PET Results With MRI Imaging in Patients With Recurrent Gliomas (n=30).||2 years|Data was not collected||||||
1452754|NCT00832598|Primary|Determine & Comp Biodistribution, Clearance, & Dosimetry of [18F]FACBC & [18F]FLT Tissue/Organs w/i the Field of View of the Dynamic PET Imag Studies prior-to & During Anti-AKT &/or Anti-VEGF Directed Therapies Alone or in Combin With Radia for Glioma.||2 years|Data was not collected||||||
1452755|NCT00832585|Secondary|Change in Physician Global Assessment (PGA) Score From Baseline (Week 1) to Week 16.|The Physician Global Assessment (PGA) evaluates the overall severity of Atopic Dermatitis (AD) at a given time using a four point scale (0=clear, 0.5=clear to mild, 1=mild, 1.5=mild to moderate, 2=moderate, 2.5=moderate to severe, and 3=severe).|Week 1 to week 16||||Scores on a scale||Full Range|Median
1452756|NCT00832585|Primary|Change in Eczema Area Severity Index (EASI) Score From Baseline (Week 1) to Week 16.|The Eczema Area Severity Index (EASI) measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) using 0=none, 1=mild, 2=moderate, 3=severe. Head/neck, upper limbs, trunk, lower limbs are rated from 1 to 6 (0=no eruption, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%). The proportional factor for the head/neck =.01, upper limbs=.02, trunk=.03 and lower limbs=.04. The algorithm for calculating the EASI is the sum of E+I+Ex+L multiplied by the area, multiplied by the proportional factor. The total score is the sum of the four body-region scores, max=72, min=0.|Week 1 to week 16|8 (4 female and 4 male) atopic patients, ranging in age from 24 to 54 yrs of age, were screened for the study. 5 patients were enrolled for 12 wks of treatment, but only 3 completed the study.|||Scores on a scale.||Full Range|Median
1452757|NCT00832572|Secondary|Response to Thermal and Mechanical Stimuli|The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.||||||
1452758|NCT00832572|Secondary|Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire|The participant quality of life assessed utilizing the SF-36v2 questionnaire|Baseline to Week 6|Study was stopped and no analyses were performed on the secondary outcome measures.||||||
1452759|NCT00832572|Primary|Reduction in Neuropathic Pain|Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)|Baseline to Week 6|Study was stopped and no analysis was performed on the primary outcome measure.||||||
1452760|NCT00832520|Secondary|To Determine if the Quality of Life Improves After Starting Mirtazapine||8 weeks|There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.||||||
1452761|NCT00832520|Primary|Change in Weight||8 weeks|There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.||||||
1452762|NCT00832455|Other Pre-specified|Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)|"The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ).~PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described."|Weeks 4, 8, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Units on a Scale||Standard Deviation|Mean
1452791|NCT00832130|Primary|Incidence of Device-related Adverse Events|Number of eyes for which a device-related AE occurred|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population.|||Events|Participants||Number
1452763|NCT00832455|Other Pre-specified|Patient Global Satisfaction|At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.|Week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Participants|||Number
1452764|NCT00832455|Other Pre-specified|Physician Global Satisfaction|At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.|week 0, 4, 8 and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Participants|||Number
1452765|NCT00832455|Secondary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.|||Participants|||Number
1452766|NCT00832455|Primary|Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.|Week 0, 4, and 12|420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4 and the 373 patients who completed week 12.|||Participants|||Number
1452767|NCT00832416|Secondary|Percentage of Participants Who Dropped Out From Trial by Dropout Reason|Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason|12 weeks|Safety population: all randomized patients who received at least one dose of the assigned study medication.|||percentage of participants|||Number
1452768|NCT00832416|Primary|Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
1452769|NCT00832416|Secondary|Investigator Global Rating of Pain Relief|"The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: How do you rate this patient’s overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.|||participants|||Number
1452770|NCT00832416|Secondary|Multiple Dose Effect Using 24-hour VAS Pain Questionnaire|Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||mm||Standard Deviation|Mean
1452771|NCT00832416|Secondary|Percentage Difference in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm).|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
1452772|NCT00832416|Secondary|Percentage Difference in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)|Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Week 0, week 3, week 6|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
1452773|NCT00832416|Primary|Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)|Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.|Baseline to week 12|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.|||Percentage difference||Standard Deviation|Mean
1452830|NCT00831766|Secondary|Median Progression-Free Survival (PFS)|Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve.|24 months|All participants treated at MTD.|||months||95% Confidence Interval|Median
1452774|NCT00832416|Primary|Patient Global Rating of Pain for the Study Period (12 Weeks)|"3-item Likert-scale: How do you rate overall pain relief with the drug? with 3 possible answers: very effective, effective, or ineffective. The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer."|12 weeks|The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Last Individual value.|||participants|||Number
1452775|NCT00832390|Primary|Change From Baseline in A1C at Week 24|"Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values."|Baseline and 24 Weeks||||Percent Difference||95% Confidence Interval|Mean
1452776|NCT00832377|Other Pre-specified|Baseline IOP|"Baseline IOP was measured at ~9 AM of first day of treatment period.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline||||mmHg||Standard Deviation|Mean
1452777|NCT00832377|Secondary|Mean Change in IOP 8 Hours After the Study Drug Administration at Week 12 Compared to Baseline IOP|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks||||mmHg||Standard Deviation|Mean
1452778|NCT00832377|Secondary|Mean Change in Trough IOP Measured Right Before Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks||||mmHg||Standard Deviation|Mean
1452779|NCT00832377|Primary|Mean Change in the Peak Intraocular Pressure (IOP) Measured Two Hours After Study Drug Administration at Week 12 Compared to Baseline IOP.|"The therapeutic goal of normal tension glaucoma treatment includes lowering IOP to prevent progression of damage in optic nerves or vision. In this trial, IOP was measured with the same tonometer throughout the study. A decreased IOP from baseline is considered an improvement.~IOP was measured in both eyes and the eye with the higher IOP was used for the participant."|Baseline and 12 weeks||||mmHg||Standard Deviation|Mean
1452780|NCT00832338|Primary|Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC)|"Patients were assessed for surgery after 6 cycles of TC (18 weeks). Pathologic stage was determined based on size of tumor and degree of lymph node involvement at the time of surgery, whereas clinical stage pre-operatively was determined by clinical assessment and imaging.~If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists."|At time of definitive surgery|Staging information was not collected for two patients.|||Participants|||Count of Participants
1452781|NCT00832299|Secondary|Observation of Overall Pathologic Response Rate, Correlation of Pathologic Staging With Pre-op Ultrasound and Pelvic MRI Staging Observed Toxicities Patterns of Disease Relapse Disease-free Survival Overall Survival||5 years|Data not collected||||||
1452782|NCT00832299|Primary|Pathologic Complete Response||3-6 months|Study terminated prior to data collection of time frame||||||
1452783|NCT00832260|Secondary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).||12 months||||percentage of patients|||Number
1452784|NCT00832260|Primary|Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.||12 months||||percentage of patients|||Number
1452785|NCT00832130|Primary|Tear Break-up Time|Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.|||Seconds|Participants|Standard Deviation|Mean
1452786|NCT00832130|Secondary|Discomfort Evaluation (Discomfort/Pain Score)|Subject-reported numeric score reflecting low or high intensity. Scores ranged from 0 to 10, with 0 being no discomfort or pain and 10 being intolerable pain.|Treatment and 1 Day|Results presented are of the Intent to Treat population. Only the Manual Mini group underwent a 1 day assessment.|||Scores on a scale|Participants|Standard Deviation|Mean
1452787|NCT00832130|Secondary|(LogMAR) Best Spectacle Corrected Visual Acuity|Measurement of BSCVA at a distance using a logMAR chart under standard illumination. The logMAR ranged from -0.30 to 1.0. A lower logMAR value is a better visual acuity.|Baseline, 2 Weeks and 4 Weeks|Results presented are of the Intent to Treat population. 2 Weeks data for the Control group are after control treatment, but before crossover treatment. 4 Weeks data for the Control group are after crossover treatment.|||LogMAR|Participants|Standard Deviation|Mean
1452788|NCT00832130|Secondary|Intraocular Pressure|Intraocular pressure (IOP) was evaluated by Goldmann applanation tonometry. Change in IOP from Baseline was assessed to confirm safety.|Baseline through 4 Weeks|Results presented are of the Intent to Treat population. Post-Treatment results for the Control group are before crossover treatment. 4 Weeks results for the Control group are after crossover treatment.|||mmHg|Participants|Standard Deviation|Mean
1452789|NCT00832130|Secondary|Ocular Surface Staining (Corneal Staining Sum Score)|Corneal staining score in five corneal regions, evaluated on a scale from 0 (none), 1 (mild), 2 (moderate) to 3 (severe). The sum of the five corneal staining scores was on a scale from 0 to 15. A lower grade indicates less corneal surface desiccation.|Baseline through 4 Weeks|Results presented are of the Intent to Treat Population. 4 Weeks data for the Control group are after treatment crossover.|||Scores on a scale|Participants|Standard Deviation|Mean
1452790|NCT00832130|Secondary|Dry Eye Symptoms (Total SPEED Score)|Standard Patient Evaluation of Eye Dryness questionnaire. Assessment of subjects' frequency and severity of dry eye symptoms. The total score was calculated as the sum scores for all symptoms over a range of 0 to 28. A lower total SPEED score represents less frequent and/or less severe symptoms.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.|||Scores on a scale|Participants|Standard Deviation|Mean
1452792|NCT00832130|Primary|Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)|Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.|Baseline, 2 Weeks and 4 Weeks|Results presented are for the Per Protocol population. 4 Weeks data for the Warm Compress Control group are after crossover.|||Scores on a scale|Participants|Standard Deviation|Mean
1452793|NCT00832117|Secondary|Number of Participants With Laboratory Abnormalities Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|Grade (Gr) 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening. Hemoglobin Gr1 <LLN - 10.0 g/dL; Gr2 <10.0 - 8.0 g/dL; Gr3 <8.0 - 6.5 g/dL; Gr4 <6.5 g/dL. White Blood Cell Count (WBC) Gr1 <lower limit of normal (LLN) - 3000/mm^3; Gr2 <3000 - 2000/mm^3; Gr3 <2000 - 1000/mm^3; Gr4 <1000/mm^3. Absolute Neutrophil Count (ANC) Gr 1 <LLN - 1500/mm^3; Gr 2 <1500 - 1000/mm^3; Gr3 <1000 - 500/mm^3; Gr 4 <500/mm^3. Platelets Gr1 <LLN - 75,000/mm^3; Gr2 <75,000 - 50,000/mm^3; Gr3 <50,000 - 25,000/mm^3; Gr4 <25,000/mm^3. Normal ranges vary by local laboratory.|Assessed at screening and weekly during treatment. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants|||participants|||Number
1452794|NCT00832117|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3 Criteria|AE=any new untoward medical occurrence/worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical event that results in death, persistent/significant incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires/prolongs inpatient hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Grade 1=Mild, 2=Moderate, 3=Severe/medically significant, 4=Life-threatening.|Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2.|All treated participants|||participants|||Number
1452795|NCT00832117|Secondary|Duration of Response in Participants With Non-small Cell Lung Cancer (NSCLC)|The duration of response will be computed for all treated subjects whose best response is either partial response (PR) or complete response (CR). The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. Subjects who neither relapse nor die will be censored on the date of their last tumor assessment.|The duration of response is measured from the time (in months) measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented progressive disease or death. (Duration of study was approximately 21 months.)|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.||||||
1452796|NCT00832117|Secondary|Percentage of Participants With Response|Response in participants with non-small cell lung cancer (NSCLC) was defined as the number of subjects in whose best response is partial response (PR) or complete response (CR) (see Outcome Measure 3 for definitions) divided by the total number of response evaluable subjects.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|This outcome measure was not analyzed as the indication for NSCLC is no longer being pursued.||||||
1452797|NCT00832117|Primary|Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Cisplatin in Combination With Ixabepilone, 32 mg/m^2|The MTD is defined as the highest dose level in which dose limiting toxicities (DLTs) during the first 21 days of the first treatment cycle are observed in less than 1 out of 3 or less than 2 out of 6 treated subjects with at least 2 subjects experiencing DLT at the next higher dose level.|Within the first 21 days of first cycle|All subjects who received at least 1 dose of either ixabepilone or carboplatin|||mg/m^2|||Number
1452798|NCT00832117|Secondary|Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)|Complete Response(CR):Disappearance of all clinical/radiological evidence of target lesions (TL) & all nontarget lesions (NTL) + no new lesions (NWL). Partial Response(PR):CR of TL + persistence of >=1 NTL (NonCR/NonPD) + no NWL; OR >=30% decrease in sum of longest diameter(LD) of all TL + CR or NonCR/NonPD in NTL + no NWL. Progressive Disease (PD):>=20% increase in sum of LD of TL regardless of NTL & NWL status; or unequivocal progression of NTL regardless of TL & NWL status; or NWL regardless of TL & NTL status. Stable Disease(SD): Neither PD nor PR in TL + CR or NonCR/NonPD in NTL + no NWL.|At End-of-Treatment visit. Median time on study therapy was 18 weeks (range: 6-69 weeks) for ixa 32 mg/m^2+cis 60 mg/m^2 arm; 6 weeks (range: 3-18 weeks) for ixa 32mg/m^2+cis 80 mg/m^2 arm.|All treated participants|||participants|||Number
1452799|NCT00832117|Primary|Participants Experiencing Dose Limiting Toxicity (DLT)|DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for >3 weeks;Gr4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever >38.5°C;thrombocytopenia <25,000 cells/mm^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.|Within the first 21 days of first cycle|all treated participants|||participants|||Number
1452800|NCT00832091|Secondary|Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers|Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84|Up to 84 days|Analysis per protocol, Intent-to-treat (ITT), using Last Observation Carried Forward (LOCF)|||Participants|||Number
1452831|NCT00831766|Secondary|Rate of Lenalidomide Related Toxicity During Maintenance Therapy|Rate of toxicities of lenalidomide as maintenance therapy according to the National Cancer Institute Common Toxicity Criteria (CTC) V3. Adverse Events: Possibly Related; Probably Related, or Definitely Related to study treatment. Events are categorized as Grade 1 or 2, or as Grade 3 or 4.|24 months|All Maintenance Phase participants.|||Participants|||Count of Participants
1452801|NCT00832091|Primary|Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days|All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE|Up to 84 days|Analysis per protocol, ITT, using LOCF|||SAEs and AEs|||Number
1452802|NCT00832078|Secondary|Haematuria||After each catheterisation|||||||
1452803|NCT00832078|Secondary|Preference||At study termination|||||||
1452804|NCT00832078|Secondary|Handling||After each catheterisation|||||||
1452805|NCT00832078|Primary|Discomfort|Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)|After each catheterisation|The number analized was the number of participants catherised with each catheter at least onze during the study(SC or SCCM)|||units on a scale||Standard Deviation|Mean
1452806|NCT00832000|Secondary|Short Form 36 - Mental Composite Score|The SF-36 is a standard quality of life instrument. The mental composite score represents the the mental burden on quality of life and is a summary of questions related to mental impact of a disease or condition (mental function, role emotional, vitality, and mental health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|The end of period 1 (week 4) and period 2 (week 9)|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452807|NCT00832000|Secondary|Short Form 36 - Physical Composite Score|The SF-36 is a standard quality of life instrument. The physical composite score represents the the physical burden on quality of life and is a summary of questions related to physical impact of a disease or condition (physical function, role physical, bodily pain, and general health). The score is nomralized to the population and ranges from 0-100, with the US normal value of 50. A lower score represents a greater impact of quality of life.|Particiapnts who experienced weakness on mexiletine in either period 1 or period 2.|All participants with SF-36 physical composite values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452808|NCT00832000|Secondary|Individualized Neuromuscular Quality of Life Scale - Summary Score|Quality of life scale for patinets with neuromuscular disorders. The INQoL summary score is a weighted average made up of 5 subdomains (activities, social relationships, independence, emotions, and body image) which document the impact of a disease on a patients' quality of life. Scores range from 0-100, and can be interpreted as the percent of maximal detrimental impact on quality of life. A higher score indicates more detrimental impact.|The end of period 1 (week 4) and period 2 (week 9)|All participants with INQoL summary score values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452809|NCT00832000|Secondary|Compound Motor Action Potentials After Long Exercise Test|Compound muscle action potential (CMAP) after long periods of exercise as a percentage of baseline.|The end of period 1 (week 4) and period 2 (week 9)|All participants with long exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
1452810|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Tibialis Anterior|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RTA values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452811|NCT00832000|Secondary|Clinical Eye Closure Myotonia Evaluation (Seconds)|Time to open the eyes after forced eye closure as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical eye closure myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.|||Seconds||95% Confidence Interval|Mean
1452812|NCT00832000|Secondary|Clinical Hand Grip Myotonia Evaluation (Seconds)|The time to open the fist after a forced handgrip as measured on a stopwatch.|The end of period 1 (week 4) and the end of period 2 (week 9)|All participants with clinical handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean. Confidence intervals are bootstrap confidence intervals.|||Seconds||95% Confidence Interval|Mean
1452813|NCT00832000|Secondary|Graded Myotonia by Needle Electromyography - Right Abductor Digiti Minimi|Measured the amount of myotonia present on needle exam by assigning a number 1-3, with 1 being minimal amount of myotonia on needle stick and 3 being maximal amount of myotonia present on needle stick.|The end of period 1 (week 4) and period 2 (week 9)|All participants with graded needle EMG of the RADM values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452814|NCT00832000|Secondary|Compound Motor Action Potentials After Short Exercise Test|The maximal post-exercise compound muscle action potential (CMAP) after short periods of exercise as a percent of the baseline measurement.|The end of period 1 (week 4) and period 2 (week 9)|All participants with short exercise test values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is taken from the mixed model. Confidence intervals are bootstrap confidence intervals.|||percentage of baseline CMAP amplitude||95% Confidence Interval|Mean
1452815|NCT00832000|Secondary|Quantitative Measure of Hand Grip Myotonia (Seconds)|Maximum voluntary contractions following forced right hand grip were recorded and the time to relax from 90% to 5% of average maximal force was determined using automated analysis software.|The end of period 1 (week 4) and period 2 (week 9)|All participants with quantitative handgrip myotonia values in either period 1 or period 2 were included in analysis. The treatment-specific group mean is a geometric-like mean using log (t+0.1) 'normalizing' transformation. Confidence intervals are bootstrap confidence intervals.|||seconds||95% Confidence Interval|Mean
1452816|NCT00832000|Secondary|Patient Reported Tiredness on the IVR|Tiredness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of tiredness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|49 partipants who experienced tiredness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452817|NCT00832000|Secondary|Patient Reported Weakness on the IVR|Weakness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of weakness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|44 partipants who experienced weakness in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452818|NCT00832000|Secondary|Patient Reported Pain on the IVR|Pain measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of pain for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeeks 3-4 of each period|48 partipants who experienced pain in either period 1 or period 2 were included in analysis. All treatment group means are extracted from the mixed effects model. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452819|NCT00832000|Primary|Patient-reported Stiffness on the IVR|Stiffness measured on a 1-9 scale, 1 being minimal, 9 the worst ever experienced. 0=no symptom reported. For analysis the average severity of stiffness for each participant was calculated from daily calls made in weeks 3-4 of each period.|Weeks 3-4 of each period|Modified intention to treat analysis (n=57). 2 subjects were excluded from analysis due to failure call the IVR system in either period. Treatment group estimates by period are taken from the mixed model, the number above reflecting the number who contributed to the model point estimate. Confidence intervals are bootstrap confidence intervals.|||units on a scale||95% Confidence Interval|Mean
1452820|NCT00831987|Primary|Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||Day 21 post-vaccination||||Percentage of Participants|||Number
1452821|NCT00831987|Primary|Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination||21 Days post-vaccination||||Percentage of Participants|||Number
1452822|NCT00831987|Primary|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine|GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.|Day 0 and Day 21 Post-Vaccination|Geometric Mean Titers were assessed in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1452823|NCT00831987|Primary|Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination|"Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site.~Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia"|0 to 3 days post-vaccination||||Percentage of Participants|||Number
1452824|NCT00831844|Primary|Disease Response|Response rates will be calculated as the percent of patients whose best response is a Complete Response (CR) or Partial Response (PR).|First six treatment cycles - 24 weeks|Grp 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Grp 3, 21 enrolled, 1 ineligible. Grp 5, 14 enrolled, 1 ineligible. Grp 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug).|||patient|||Number
1452825|NCT00831779|Secondary|Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)|||mU/L*min||Standard Error|Mean
1452826|NCT00831779|Primary|Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.|From Baseline to Week 12|All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF)|||% Change of Baseline Insulin Sensitivity||Standard Error|Mean
1452827|NCT00831766|Other Pre-specified|Median Relapse-Free Survival (RFS)|Relapse-Free Survival (RFS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be analyzed similarly. Descriptive analysis was planned for this measure.|24 Months|||||||
1452828|NCT00831766|Other Pre-specified|Rate of Cytogenetic Remission Following Induction Therapy|Rate of cytogenetic remission following induction therapy. Descriptive analysis was planned for this measure.|24 Months|||||||
1452829|NCT00831766|Secondary|Median Overall Survival (OS)|Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure.|Up to 24 Months|All participants treated at MTD|||months||95% Confidence Interval|Median
1452832|NCT00831766|Primary|Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)|Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).|24 months|All participants treated at MTD|||percentage of participants|||Number
1452833|NCT00831766|Primary|Phase I: Recommended Phase II Dose|For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.|18 months|Phase I participants.|||mg/day|||Number
1452834|NCT00831753|Secondary|Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.~Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable."|Day 0 up to Day 7 after each injection|Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population).|||Participants|||Number
1452835|NCT00831753|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.|Day 150 (1 month after dose 3)|Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1452836|NCT00831753|Primary|Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.|"Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as:~Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL.~Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL."|Day 150 (1 month after dose 3)|Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
1452837|NCT00831753|Primary|Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™|Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.|Day 150 (1 month after dose 3)|Seroprotection against Hep B was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).|||Participants|||Number
1452838|NCT00831701|Secondary|Number of Participants Requiring Active Treatment|The number of participants requiring active treatment was recorded. Shock wave lithotrypsy (SWL), ureterorenoscopy (URS) or insertion of an ureteral catheter were considered as active treatment.|21 days||||participants|||Number
1452839|NCT00831701|Secondary|Maximum Daily Pain Score|All patients kept a diary to record the score of every painful episode on a 10-cm visual analogue scale (0= no pain at all; 10= strongest pain one can imagine).|Until stone expulsion or up to 21 days||||Units on a scale||Full Range|Median
1452840|NCT00831701|Secondary|Required Analgesics|Oral diclophenac (up to 3x50 mg pills) as first-line and oral metamizole (up to 8x 500mg pills)as second-line on-demand analgesics were prescribed. All patients were requested to record the required amount of pills per day|Until stone expulsion or up to 21 days||||pills per day||Inter-Quartile Range|Median
1452841|NCT00831701|Secondary|Time to Stone Passage|The patient-defined time of stone expulsion was considered the event for time to stone passage. Patients with unnoticed stone expulsion were censored at the date of last positive stone status, and those who discontinued the therapy were censored at the date of last medication intake. Kaplan-Meier estimates were computed for time to stone passage.|21 days||||days||Inter-Quartile Range|Median
1452842|NCT00831701|Primary|Number of Participants With Stone Expulsion|The primary end point was the number of patients per group experiencing stone expulsion until day 21, as confirmed by low-dose abdominal computed tomography (CT).|21 days||||Participants|||Number
1452843|NCT00831675|Other Pre-specified|Percentage of Participants With a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroconversion)|Seroconversion defined as the percentage of participants with a ≥ 4-fold increases in titer from pre- to post-vaccination with Fluzone®.|Day 14 post-vaccination|Seroconversion were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1452844|NCT00831675|Other Pre-specified|Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection)|Seroprotection defined as percentage of participants with reciprocal hemagglutination inhibition titers ≥40 post-vaccination with Fluzone®.|14 days post-vaccination|Seroprotection were evaluated in the per-protocol population|||Percentage of Participants|||Number
1452845|NCT00831675|Other Pre-specified|Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine 2004-2005 Pediatric Formulation||14 days post-vaccination|GMTs were evaluated in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
1454250|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 24 for On-ART Participants|Results reported are for HIV-1 RNA at week 24 for on-ART participants.|At week 24|Analysis is based on all on-ART participants with HIV-1 RNA data at week 24.|||participants|||Number
1452846|NCT00831675|Primary|Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation|"Solicited local reactions: Erythema, bruising, induration, pain at injection site.~Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection."|Days 0-3 Post-dose|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population|||Participants|||Number
1452847|NCT00831493|Primary|Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation|MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).|Toxicity assessment at 6 weeks following chemoradiation (6 weeks)|Analysis per protocol; Of the three participants enrolled only two were eligible for MTD calculation.|||mg|||Number
1452848|NCT00831480|Primary|Disease Progression Diagnosed by Biopsy|Clinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.|up to one year||||participants|||Number
1452849|NCT00831441|Secondary|Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants|Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
1452850|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants|ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
1452851|NCT00831441|Secondary|Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants|ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
1452852|NCT00831441|Primary|Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants|TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days.|From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years|All participants who received at least one dose of blinded study drug and signed informed consent were analyzed.|||percentage of participants/100-pt years|||Number
1452853|NCT00831441|Secondary|Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|"Cause of death was determined by the principal condition that caused the death, not the immediate mode of death.~CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination)."|Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452854|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452855|NCT00831441|Secondary|Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452856|NCT00831441|Secondary|Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants|Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination.|Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452857|NCT00831441|Secondary|Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants|MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (≥0.04 s) Q waves in ≥2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice.|Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452858|NCT00831441|Secondary|Event Rate of Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination).|Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452873|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve > 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||percentage of time||Inter-Quartile Range|Median
1452859|NCT00831441|Secondary|Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants|Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452860|NCT00831441|Primary|Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants|Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).|Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years|All randomized participants were analyzed.|||percentage of participants/100-pt years|||Number
1452861|NCT00831428|Secondary|Mini Nasal Lavage||This test will be performed prior to entering the pool, and on exiting the pool|||||||
1452862|NCT00831428|Secondary|Skin Prick Test||This test will be performed once on a district and once on a national squad training day|||||||
1452863|NCT00831428|Secondary|Nasal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool|||||||
1452864|NCT00831428|Primary|Tidal Nitric Oxide||This test will be performed prior to entering the pool, and on exiting the pool|Data from all participants was analysed|||ppb||95% Confidence Interval|Geometric Mean
1452865|NCT00831428|Secondary|Sport-based Challenge||This test will be performed once on a district and once on a national squad training day|||||||
1452866|NCT00831428|Secondary|Mannitol Challenge||This test will be performed once on a district and once on a national squad training day|||||||
1452867|NCT00831415|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.|Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment|Safety population: all enrolled participants who received at least 1 dose of study treatment in this extension study.|||percentage of participants|||Number
1452868|NCT00831415|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score|CGI-S is a 7-point clinician rated scale to assess severity of current illness state. Range is 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected.|Baseline (Extension Study) up to Day 308 or FOT Evaluation|ITT; LOCF and Observed cases (non-missing data); (n)=number of participants with analyzable data at observation.|||scores on a scale||95% Confidence Interval|Mean
1452869|NCT00831415|Secondary|Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)|CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Day 308 or FOT Evaluation|ITT; LOCF. Improvement measured against CGI-I baseline (Day -1) data in Core study (NCT00798707 [3151A1-3359 / B2061003]).|||participants|||Number
1452870|NCT00831415|Primary|Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score|"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last on-therapy evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit."|Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation|Intent to treat (ITT): all enrolled participants who received at least 1 dose of study treatment in Extension Study and at least 1 available post-baseline evaluation for any endpoint; (n)=number of participants with analyzable data at observation.|||scores on a scale||95% Confidence Interval|Mean
1452871|NCT00831389|Post-Hoc|Overall Incidence of Hypoglycemia|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||hypoglycemic events||Inter-Quartile Range|Median
1452872|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.|For each subject and study phase, the percentage of the PG curve < 70 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||percentage of time||Inter-Quartile Range|Median
1452874|NCT00831389|Secondary|Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.|For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL. Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.|Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.|All subjects were used for final analysis|||percentage of time||Inter-Quartile Range|Median
1452875|NCT00831389|Secondary|Overnight Nadir Plasma Glucose (PG)|For each subject and study phase, the overnight nadir PG for each of two nights were determined. The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.|Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
1452876|NCT00831389|Secondary|Nadir Plasma Glucose (PG) Immediately Following Exercise|The PG nadir observed following the start of exercise|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
1452877|NCT00831389|Secondary|Peak Post-prandial Plasma Glucose (PG)|For each subject and study phase, the six peak PG following each of the six meals were determined. The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.|Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
1452878|NCT00831389|Primary|Incidence of Nocturnal Hypoglycemia Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.|All subjects were used for final analysis|||hypoglycemic events||Inter-Quartile Range|Median
1452879|NCT00831389|Primary|Incidence of Hypoglycemia Immediately Following Exercise|Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL. Maximum tally of hypoglycemic events within any 30 minute period is 1.|Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.|All subjects were used for final analysis|||hypoglycemic events||Inter-Quartile Range|Median
1452880|NCT00831389|Primary|Plasma Glucose (PG) Response to Exercise|PG at start of exercise minus the subsequent PG nadir|Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.|All subjects were used for final analysis|||mg/dL||Inter-Quartile Range|Median
1452881|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.~Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry."|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.|||Participants|||Number
1452882|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intend-to-treat) population.|||Participants|||Number
1452883|NCT00831311|Secondary|Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™|Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites|Day 0 up to Day 7 post-vaccination|Safety was assessed on the safety analysis (intent-to- treat) population.|||Participants|||Number
1452884|NCT00831311|Primary|Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the Polio Antigens were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1452885|NCT00831311|Primary|Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).|Day 150 (1 month post-vaccination 3)|Geometric mean titers to the vaccine antigens were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1452900|NCT00831181|Secondary|Patterns of Disease Failure, Including Local Recurrence and Distant Metastasis Assessed by CT Scan||median follow-up 22 months|Out of the 27 patients enrolled, a total 23 underwent TME and were assessed for patterns of disease failure.|||patients|||Number
1452901|NCT00831181|Secondary|Overall Survival||median follow-up 22 months|Patients who completed treatment|||participants|||Number
1452902|NCT00831181|Secondary|Disease-free Survival||median 22 months follow-up|Out of the 27 patients enrolled, a total 23 underwent TME and were assessed for disease-free survival.|||participants|||Number
1452886|NCT00831311|Primary|Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|"Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.~Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination."|Day 150 (1 month post-vaccination 3)|Seroprotection to the vaccine antigens was assessed in the per-protocol population.|||Percentage of Participants|||Number
1452887|NCT00831311|Primary|Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®|Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.|1 month post last vaccination|Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.|||Percentage of Participants|||Number
1452888|NCT00831272|Primary|Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial.||12 weeks|Repeated weekly measures of drinking outcomes were compared using generalized estimating equation models (GEE). The explanatory variables of primary interest comprised binary indicators for intervention group, genotype, and their interaction, a linear trend for time, and terms for interactions involving time and the group and genotype factors.|||percentage of heavy drinking days||Standard Deviation|Mean
1452889|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables|The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.|Baseline to 12 weeks of treatment|FAS.|||participants|||Number
1452890|NCT00831233|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.|Baseline to 12 weeks of treatment|FAS. One participant in the degarelix group did not have any assessment of vital signs or body weight (the number of participants in this group is thus 26).|||participants|||Number
1452891|NCT00831233|Secondary|Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit|The IPSS questionnaire included an additional single question to assess the participant’s QoL in relation to his urinary symptoms. The question was: ‘If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?’ The possible answers to this question ranged from ‘delighted’ (a score of ‘0’) to ‘terrible’ (a score of ‘6’). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.|||score on scale||Standard Deviation|Mean
1452892|NCT00831233|Secondary|Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.|||percentage||Full Range|Median
1452893|NCT00831233|Secondary|Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit||After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, OC.|||participants|||Number
1452894|NCT00831233|Secondary|Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12|TRUS is a method of measuring the size of the prostate.|After 12 weeks treatment compared to Baseline|FAS, Observed Cases (OC).|||mL||Standard Deviation|Mean
1452895|NCT00831233|Secondary|Change From Baseline in Residual Volume (Vresidual) at Each Visit|Uroflowmetry was used to quantify the residual volume (Vresidual; mL)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.|||mL||Standard Deviation|Mean
1452896|NCT00831233|Secondary|Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit|Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)|After treatment of 4, 8 and 12 weeks compared to Baseline|FAS, LOCF.|||mL/sec||Standard Deviation|Mean
1452897|NCT00831233|Secondary|Change From Baseline in Total IPSS at Weeks 4 and 8|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 4 and 8 weeks compared to Baseline|FAS, LOCF.|||score on scale||Standard Deviation|Mean
1452898|NCT00831233|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.|After treatment of 12 weeks compared to Baseline|Full Analysis Set (FAS) + Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF).|||score on scale||Standard Deviation|Mean
1452899|NCT00831181|Secondary|Number of Participants With Comparison of Preoperative Stage With Post-treatment Pathologic Stage|Thin-section high resolution pelvic MRI was used to image the tumor prior to chemoradiation and repeated prior to surgery, and then compared to post-treatment pathological stage.|Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.|Out of the 27 patients enrolled, a total 23 underwent TME. These 23 patients were included for comparison of preoperative stage and post-treatment pathologic stage.|||patient|||Number
1452905|NCT00831181|Secondary|Treatment Toxicity|Toxicity was assessed weekly during neoadjuvant chemotherapy and radiation therapy, bi-weekly during adjuvant FOLFOX therapy.|Weekly during chemoradiation treatment (3 months). Bi-weekly during adjuvant FOLFOX therapy (3.5 months).|According to the citation J Clin Oncol 28,2010 (suppl; abstract e14128): acute grade 3-4 toxicities occurred in 16 patients, mainly hypersensitivity reactions and OXA associated peripheral neuropathy.|||patients|||Number
1452906|NCT00831181|Primary|Pathologic Response and Complete Response|"Pathologic Response and Complete Response to preoperative therapy will be determined at the time of surgical resection. All grossly visible areas of ulceration and/or induration with be measured and submitted for histological evaluation.~The unit of measure is the tumor response rate to preoperative chemoradiation.~Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer.~Tumor regression grade (TRG) will be quantitated into five grades:~TRG 1 (complete regression) -absence of residual cancer and fibrosis extending from the site of original tumor through the layers of the rectal wall.~TRG 2 characterized by the presence of rare residual cancer cells scattered through the fibrosis.~TRG 3 characterized by an increase in the number of residual cancer cells, but fibrosis still predominant.~TRG 4 -residual cancer outgrowing fibrosis. TRG 5 characterized by absence of regressive changes."|Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months|Number of subjects undergoing TME|||Participants|||Number
1452907|NCT00831129|Secondary|Change in Body Mass Index|change in body mass index between baseline and 6 month|Baseline and 6 months||||kg/m2||Standard Deviation|Mean
1452908|NCT00831129|Secondary|Change in Adiponectin|change in Adiponectin between baseline and 6 month|Baseline and 6 months||||μg/ml||Standard Deviation|Mean
1452909|NCT00831129|Secondary|Change in Homeostatic Model Assessment for Insulin Resistance|change in homeostatic model assessment for insulin resistance between baseline and 6 month|Baseline and 6 months||||HOMA units||Standard Deviation|Mean
1452910|NCT00831129|Secondary|Change in Insulin|change in Insulin between baseline and 6 month|Baseline and 6 months||||IU/ml||Standard Deviation|Mean
1452911|NCT00831129|Secondary|Change in Fasting Blood Glucose|change in fasting blood glucose between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
1452912|NCT00831129|Secondary|Change in Glycosylated Haemoglobin|change in glycosylated haemoglobin between baseline and 6 month|Baseline and 6 months||||percentage of glycosylated haemoglobin||Standard Deviation|Mean
1452913|NCT00831129|Secondary|Change in High-density Lipoprotein|change in high-density lipoprotein between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
1452914|NCT00831129|Secondary|Change in Triglycerides|change in Triglycerides between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
1452915|NCT00831129|Secondary|Change in Low-density Lipoprotein|change in low-density lipoprotein between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
1452916|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure|change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
1452917|NCT00831129|Secondary|Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure|change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
1452918|NCT00831129|Secondary|Change in Office Diastolic Blood Pressure|change in office diastolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
1452919|NCT00831129|Secondary|Change in Office Systolic Blood Pressure|change in office systolic blood pressure between baseline and 6 month|Baseline and 6 months||||mm Hg||Standard Deviation|Mean
1452920|NCT00831129|Secondary|Change in Malondialdehyde|change in Malondialdehyde between baseline and 6 month|Baseline and 6 months||||nM||Standard Deviation|Mean
1452921|NCT00831129|Secondary|Change in Urinary Isoprostane|change in urinary isoprostane between baseline and 6 month|Baseline and 6 months||||ng/ml||Standard Deviation|Mean
1452922|NCT00831129|Primary|Change in High-sensitivity C-reactive Protein|change in high-sensitivity C-reactive between baseline and 6 month|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
1452923|NCT00830960|Secondary|Risk of CV Death, Nonfatal MI, Nonfatal Stroke, UTVR, or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
1452924|NCT00830960|Secondary|Genetic Variation Related to Drug Metabolism and Transport Substudy Result Summary|"The primary hypothesis for the genetics substudy was that CYP2C19 genetic variation has a significant effect on pharmacodynamic (PD) response to clopidogrel but not on PD response to prasugrel per change in PRU as measured by the Accumetrics VerifyNow P2Y12 device.~Participants were classified by CYP2C19 genotype into predicted metabolic phenotypes according to literature-based functional predictions. These classifications were clustered into 2 groups: extensive metabolizer (EM) and reduced metabolizer (RM).~A higher value for change in PRU indicates a greater level of platelet inhibition."|Baseline to 4 hours post-loading dose (LD), 30 days and 90 days during maintenance dose (MD) phase|"Pharmacodynamic analysis set is subset of FAS (≥1 genetics sample, ≥1 dose of study drug, ≥1 post-baseline PRU measurement, no significant protocol violations). Genetics subset LD population never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization.~Participants classified as EM or RM. Invalid measurements of PRU were excluded."|||Change in PRU||Standard Deviation|Mean
1452925|NCT00830960|Secondary|Inpatient Healthcare Resource Utilization|Healthcare resource utilization data were modeled from historical analyses to determine initial hospitalization costs, total 30-day medical care costs, and total 90-day medical care costs.|Initial hospitalization, 30 days, 90 days|As a consequence of the overall low number of reported clinical events, inpatient healthcare resource utilization data were not analyzed; thus zero participants were analyzed.|||participants|||Number
1452926|NCT00830960|Secondary|Incidence of CABG-related TIMI Major or Minor Bleeding.||Randomization through end of study (90 days)|"Safety Analysis Set (SAS): all randomized participants with at least 1 dose of study drug~In 10 participants, study drug discontinued due to planned CABG. 1 participant had CABG reported on revascularization case report form (CRF); no reports of CABG bleeding event"|||participants|||Number
1452927|NCT00830960|Secondary|Incidence of Non-coronary Artery Bypass Graft (CABG) Related Thrombolysis in Myocardial Infarction (TIMI) Life-threatening (a Subset of Non-CABG-related TIMI Major Bleeding), Major, Minor, and Minimal Bleeding|"Bleeding events were classified and analyzed in accordance with the TIMI criteria definitions.~Major bleeding: any intracranial hemorrhage (ICR) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL) from baseline.~Minor bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 but <5 gm/dL from baseline.~Insignificant bleeding: any bleeding event that does not meet criteria for a Major or Minor bleed."|Randomization through end of study (90 days)|"Safety analysis set (SAS): all randomized participants with at least 1 dose of study drug~Two (2) participants had no event date; time from start of therapy to event was missing and thus they were not included in this table."|||participants|||Number
1452928|NCT00830960|Secondary|Risk of All-cause Death in Primary Cohort and Low Weight/Elderly Cohort|Risk was defined as the number of participants with events of all-cause death.|Randomization through end of study (90 days)|Full Analysis Set (FAS): all randomized subjects who received at least 1 dose of study drug|||Participants|||Number
1452929|NCT00830960|Secondary|Risk of Definite, Probable, or Possible Stent Thrombosis Per Academic Research Consortium (ARC) Definition|"Risk was defined as the number of participants with events of definite, probable, or possible stent thrombosis.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
1452930|NCT00830960|Secondary|Risk of Definite or Probable Stent Thrombosis Per ARC (Academic Research Consortium) Definition|"Risk was defined as the number of participants with events of definite or probable stent thrombosis.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
1452931|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Urgent Target Vessel Revascularization (UTVR), or Recurrent Myocardial Ischemia Requiring Hospitalization (Analyzed Individually)|Risk was defined as the number of participants with events of CV death, nonfatal MI, nonfatal stroke, UTVR, or recurrent myocardial ischemia requiring hospitalization.|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
1452932|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Recurrent Myocardial Ischemia Requiring Hospitalization|"Risk was defined as the number of events of CV death, nonfatal MI, nonfatal stroke or recurrent myocardial ischemia requiring hospitalization.~Recurrent myocardial ischemia requiring hospitalization: rehospitalization for symptoms of myocardial ischemia at rest with either new ST-segment deviation ≥1 mm, or performance of a coronary revascularization procedure percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the same hospital stay.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||Participants|||Number
1452933|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or UTVR.~UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||Participants|||Number
1452934|NCT00830960|Secondary|Risk of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Non-fatal Stroke|"Risk was defined as the number of participants with events of CV death, nonfatal MI, or nonfatal stroke.~CV death: death caused by CV event or not clearly attributable to non-CV causes.~Nonfatal MI: per adapted American College of Cardiology definition.~Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting more than 24 hours; either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.~As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed."|30 days and 90 days|As a consequence of the overall low number of reported clinical events, composite endpoints were not analyzed; thus zero participants were analyzed.|||participants|||Number
1452935|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Days During Maintenance Dose (MD) Administration in Primary Cohort|"Efficacy analyses are analyzed and presented separately for the loading dose (LD) and MD phase. This primary outcome analysis compares PRU for the 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with the clopidogrel 75-mg MD at 30 days post-MD in the primary cohort (participants who weighed ≥60 kg and were <75 years).~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of LS mean difference between prasugrel and clopidogrel."|At 30 days during MD therapy|"Per protocol set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event"|||PRU||Standard Deviation|Mean
1453010|NCT00830310|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale (CGI)|The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1452936|NCT00830960|Secondary|Summary of Myocardial Infarction (MI), Stroke, Stent Thrombosis and Urgent Target Vessel Revascularization (UTVR) in Primary Cohort and Low Weight/Elderly Cohort|"Nonfatal MI: American College of Cardiology (ACC) definition Nonfatal stroke: rapid onset of new, persistent neurologic deficit lasting >24 hours; classified as either ischemic or hemorrhagic based on imaging data, if available, or uncertain cause if imaging data was not available.~Stent thrombosis: defined as definite, probable, or possible, based on Academic Research Consortium definitions.~UTVR: percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for recurrent ischemia. Revascularization must have included the vessel(s) dilated at the initial procedure"|Randomization through end of study (90 days)|"Full analysis set (FAS)~FAS: all randomized subjects who received at least 1 dose of study drug"|||Participants|||Number
1452937|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) During the Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 days and at 90 days during MD therapy|"Per Protocol Set (PPS) MD population~PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations~MD population: received percutaneous coronary intervention (PCI) for index event"|||Percent inhibition|||Number
1452938|NCT00830960|Secondary|Percent Inhibition of Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) at 30 Minutes, 2 Hours, and 4 Hours Post-Loading Dose (LD) in Primary in Primary Cohort and Low Weight/Elderly Cohort|A higher percentage (percent inhibition least squares mean [LS mean]) represents greater platelet inhibition.|30 minutes, 2 hours, and 4 hours following LD administration|Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event|||Percent inhibition|||Number
1452939|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at During Maintenance Dose (MD) Phase at 30 Days and 90 Days in Primary Cohort and Low Weight/Elderly Cohort|"Efficacy analyses analyzed and presented separately for loading dose (LD) and MD phase. Analysis compares PRU for 3 prasugrel MDs (10 mg, 7.5 mg, and 5 mg) with clopidogrel 75-mg MD at 30 days post-MD.~Data for Primary Cohort at 30 days post-LD, already presented in second Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of least squares (LS) mean difference between prasugrel and clopidogrel."|At 30 Days and 90 days during MD therapy|Per Protocol Set (PPS) MD population PPS: all randomized participants who had at least 1 dose of study drug, ≥1 post-baseline platelet aggregation measurement, and no significant protocol violations in MD population: received percutaneous coronary intervention (PCI) for index event|||PRU||Standard Deviation|Mean
1452940|NCT00830960|Secondary|Adenosine Diphosphate (ADP)-Induced P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 30 Minutes, 2 and 4 Hours Post-Loading Dose (LD) in Primary (≥60 kg and <75 Years) and Low Weight/Elderly (<60 kg or ≥75 Years) Cohorts.|"Efficacy analyses analyzed and presented separately for LD and maintenance dose (MD) phase. Analysis compares PRU for prasugrel LDs (30 mg and 60 mg) with clopidogrel 300-mg LD at 30 minutes post-LD.~Data for Primary Cohort at 4 hours post-LD, already presented in first Primary Outcome Measure, are also presented here.~ADP-induced PRU serves as biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values presented with statistical comparisons of least-squares mean (LS mean) difference between prasugrel and clopidogrel."|At 30 minutes, 2 hours, and 4 hours following LD administration|"Per Protocol Set (PPS) LD population PPS: all randomized participants with at least 1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP)IIb/IIIa inhibitor during index hospitalization, received percutaneous coronary intervention (PCI) for index event"|||PRU||Standard Deviation|Mean
1452941|NCT00830960|Primary|Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation (P2Y12 Reaction Units; PRU) Using the Accumetrics VerifyNow (VN) P2Y12 Assay at 4 Hours Post-Loading Dose (LD) in Primary Cohort (≥60 kg and <75 Years)|"ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition.~Observed PRU values are presented with statistical comparisons of difference in least squares mean (LS mean) PRU values between prasugrel and clopidogrel.~Efficacy analyses are analyzed and presented separately for the LD and maintenance dose (MD) phase."|At 4 hours following LD administration|"Per Protocol Set (PPS) LD population~PPS: all randomized participants with ≥1 dose study drug, ≥1 post-baseline platelet aggregation measurement, no significant protocol violations~LD population: never used glycoprotein (GP) IIb/IIIa inhibitor during index hospitalization and received percutaneous coronary intervention (PCI) for index event"|||PRU||Standard Deviation|Mean
1452942|NCT00830947|Primary|The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.||Time to Space Closure, an average of 22 weeks||||mm/week||Standard Deviation|Mean
1452943|NCT00830804|Secondary|Plasma Trough Concentration of Darunavir|Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one DRV plasma trough concentration obtained within 20-28 hours after the last DRV dose were included in the analysis.|||ng/ml||Inter-Quartile Range|Median
1452957|NCT00830804|Secondary|Change in Plasma HIV-1 RNA From Baseline to Week 1|Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.|Baseline and week 1|Analyis was based on an intent-to-treat approach, ignoring whether a participant was on or off study treatment at the time the sample for HIV-1 RNA was obtained.|||log10 copies/ml||Inter-Quartile Range|Median
1452944|NCT00830804|Secondary|Plasma Trough Concentration of Raltegravir|Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.|From start of study treatment to week 52|Participants who started study treatment and who have at least one RAL plasma trough concentration obtained within 9-15 hours after the last RAL dose were included in the analysis.|||ng/ml||Inter-Quartile Range|Median
1452945|NCT00830804|Secondary|Change in CD4 Count at Week 48|Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.|From start of study treatment through week 48|Only those participants who started study treatment and who have values at baseline and at week 48 were included in the analysis.|||cells/mm3||Inter-Quartile Range|Median
1452946|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
1452947|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48|Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 48|Only those participants who started study treatment and who had fasting lipid measurements at week 48 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
1452948|NCT00830804|Secondary|Change in Fasting Low-density Lipoprotein at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
1452949|NCT00830804|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24|Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.|From start of study treatment through week 24|Only those participants who started study treatment and who had fasting lipid measurements at week 24 and week 0 were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
1452950|NCT00830804|Secondary|Number of Participants With Perfect Overall Adherence by Self Report|"At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall perfect adherence."|From one week after starting study treatment to week 52|All participants who started study treatment were included in the analysis.|||participants|||Number
1452951|NCT00830804|Secondary|Number of Participants With Protease Drug Resistance at Virologic Failure|Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful protease genotyping at failure were included in the analysis.|||participants|||Number
1452952|NCT00830804|Secondary|Number of Participants With Integrase Drug Resistance at Virologic Failure|Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.|From 12 weeks after starting study treatment to week 52|Only those participants who had virologic failure (see primary outcome measure for definition) and who had successful integrase genotyping at failure were included in the analysis.|||participants|||Number
1452953|NCT00830804|Secondary|Number of Participants With Pretreatment Drug Resistance|Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.|At screening|All participants who started study treatment were included in the analysis.|||participants|||Number
1452954|NCT00830804|Secondary|Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.|From start of study treatment to week 52|All participants who started study treatment were included in the analysis.|||proportion of participants||95% Confidence Interval|Number
1452955|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48|Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.|From start of study treatment to week 48|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off study treatment or with missing HIV-1 RNA at week 48.|||proportion of participants||95% Confidence Interval|Number
1452956|NCT00830804|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24|Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.|From start of study treatment to week 24|All participants who started study treatment were included. An intent-to-treat approach was used ignoring participants who were off-study or with missing HIV-1 RNA at week 24.|||proportion of participants||95% Confidence Interval|Number
1452958|NCT00830804|Secondary|Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24|The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to Week 24|All participants who started study treatment were included in the analysis.|||Proportion of participants||95% Confidence Interval|Number
1452959|NCT00830804|Primary|Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24|Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.|From start of study treatment to week 24|All participants who started study treatment were included. The intent-to-treat approach was used, ignoring whether a participant was on or off treatment at the time of HIV-1 RNA measurement and censoring follow-up if a participant was lost-to-follow-up without previously meeting the definition of virologic failure.|||Proportion of participants||95% Confidence Interval|Number
1452960|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452961|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to < 50 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452962|NCT00830791|Secondary|Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|The glucose concentration-time profile was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|Up to 12 Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452963|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452964|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452965|NCT00830791|Secondary|CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls|CICR was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452966|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 5 mg of MK-0941 versus controls with normal renal function that received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of < 30 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452967|NCT00830791|Secondary|Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452968|NCT00830791|Secondary|Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls|Fe was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|36-Hours Post-Dose|This study was discontinued early and this evaluation was not conducted.||||||
1452969|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
1452970|NCT00830791|Secondary|T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency that received 20 mg of MK-0941 versus controls with normal renal function that received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||Standard Deviation|Geometric Mean
1452971|NCT00830791|Secondary|Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|T 1/2 was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||Standard Deviation|Geometric Mean
1452972|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
1452973|NCT00830791|Secondary|Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||95% Confidence Interval|Geometric Mean
1452974|NCT00830791|Secondary|Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Tmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose||||Hours||95% Confidence Interval|Geometric Mean
1452975|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency who received 5 mg of MK-0941 versus controls with normal renal function who received 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
1452976|NCT00830791|Secondary|Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||nM||95% Confidence Interval|Geometric Mean
1452977|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of > 30 mL/min/1.73m^2.|72-Hours Post-Dose|This study was discontinued early and participants were not treated with the 5 mg dose.||||||
1452978|NCT00830791|Primary|Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m^2.|72-Hours Post-Dose||||nM per Hour||95% Confidence Interval|Geometric Mean
1452979|NCT00830791|Primary|Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of > 50 to 80 mL/min/1.73m^2.|72 Hours Post-Dose||||nM per Hour||95% Confidence Interval|Geometric Mean
1452980|NCT00830791|Secondary|Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls|Cmax was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency who received 20 mg of MK-0941 versus controls with normal renal function who received 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour CLCR of > 50 to 80 mL/min/1.73m^2.|72-Hours Post-Dose||||nM||95% Confidence Interval|Geometric Mean
1452981|NCT00830765|Primary|Weeks Gestation at Birth Among Patients Receiving the Active Drug.|Weeks gestation at birth, the interval to delivery, or neonatal morbitity.|Through delivery, until discharge up to 40 weeks gestation|Intention to treat analysis in both groups|||weeks||Standard Deviation|Mean
1452982|NCT00830596|Primary|Response to Sudden Load Response Times|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)|Baseline and 2 weeks||||ms||95% Confidence Interval|Mean
1453008|NCT00830310|Secondary|Change in Functional Status as Measure by the Global Assessment of Functioning Scale (GAF)|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1452983|NCT00830596|Primary|Response to Sudden Load, Peak Muscle Response Per Side|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)|Baseline and 2 weeks||||% muscle response||95% Confidence Interval|Mean
1452984|NCT00830596|Primary|Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL|Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure|Baseline and 2 weeks||||mm||95% Confidence Interval|Mean
1452985|NCT00830596|Primary|Postural Sway Speed|"Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:~Sway Speed=overall center of pressure traveling distance divided by time."|Baseline and 2 weeks||||mm/s||95% Confidence Interval|Mean
1452986|NCT00830596|Primary|Postural Sway|"Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for:~Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction."|Baseline and 2 weeks||||mm||95% Confidence Interval|Mean
1452987|NCT00830518|Secondary|Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events|Abnormal Laboratory Values for Chemistry or Hematology tests that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. A treatment­-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 18.9 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
1452988|NCT00830518|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events|Vital signs measurements (blood pressure, heart rate, and oral temperature) were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 18.9 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
1452989|NCT00830518|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator.|First dose of study drug to 30 days after last dose (Up to 18.9 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
1452990|NCT00830518|Secondary|Best Overall Hematologic Improvement (HI) Response for Myelodysplastic Syndrome Based on Investigator Assessment|Best overall HI response is defined as percentage of participants with response as assessed by Investigator based on IWG criteria: 1)Erythroid response (pretreatment,<11 g/dL): hemoglobin (Hgb) increase by ≥1.5 g/dL, relevant reduction of units of red blood cell (RBC) transfusions by absolute number of at least 4 RBC transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks. Only RBC transfusions given for Hgb of ≤9.0 g/dL pretreatment will count in RBC transfusion response evaluation. 2)Platelet response (pretreatment,<100x10^9/L):Absolute increase of ≥30x10^9/L for participants starting->20x10^9/L platelets, increase <20x10^9/L to >20x10^9/L by at least 100%. 3)Neutrophil response (pretreatment,<1.0x10^9/L):At least 100% increase and an absolute increase >0.5x10^9/L. 4)Progression or relapse after HI:At least 1 of following: 50% decrement from maximum response levels in granulocytes or platelets, or reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Safety population was defined as all participants who received any amount of alisertib.|||percentage of participants|||Number
1452991|NCT00830518|Secondary|Duration of Response (DOR)|Duration of response is defined as the time from the date of first documentation of a response to the date of first documented PD.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Response-­Evaluable Population included all participants who had measurable disease, received at least 1 dose of alisertib, and had at least 1 post baseline response assessment. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better.|||days||95% Confidence Interval|Median
1452992|NCT00830518|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first study drug administration to the date of first documented progressive disease (PD) or death.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.|||days||95% Confidence Interval|Median
1453009|NCT00830310|Secondary|Change in Overall Treatment Attitudes as Measured by the Drug Attitude Inventory (DAI)|The minimum score is 0 and the maximum score is 10. A higher score implies a better attitude.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1452993|NCT00830518|Primary|Best Overall Response Rate (ORR) Based on Investigator’s Assessment|Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils >1x10^9/L, platelets >100x10^9/L, bone marrow blasts(BMB) <5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB <5%, transfusion independent, no EMD; PR=neutrophils >1x10^9/L, platelets >100x10^9/L, BMB >50% decrease and 5% to 25%, blasts <5% with Auer rods; PRi=BMB >50% decrease and 5% to 25%. MDS:CR=bone marrow: ≤5% myeloblasts with normal maturation, peripheral blood: hemoglobin ≥11 g/dL, platelets ≥100x10^9/L, neutrophils ≥1.0x10^9/L, blasts 0%; PR=all CR criteria if abnormal before treatment except: BMB decreased by ≥50% over pretreatment but still >5%; PRi=BMB decreased by ≥50% over pretreatment but still >5%; Marrow CR=bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment, peripheral blood hematologic improvement responses noted.|Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)|Response-Evaluable Population included all participants who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment. In 2 participants disease transformed from MDS to AML. One participant is considered AML and one participant is considered MDS in the calculation, based on the timing of their transformation.|||participants|||Number
1452994|NCT00830440|Secondary|Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12||Baseline to Week 12 of treatment|Type 2 Diabetes Subjects|||Participants|||Count of Participants
1452995|NCT00830440|Secondary|% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks|The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline.|12 weeks||||% participants|||Number
1452996|NCT00830440|Primary|Total Weight Change From Baseline at 12 Weeks in kg||12 weeks|26 subjects received the device. 2 subjects had the device removed before 12 weeks.|||kg||Standard Deviation|Mean
1452997|NCT00830388|Secondary|To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events.|Adverse events were used to assess safety.|4 weeks||||events|||Number
1452998|NCT00830388|Primary|The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor|Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically.|4 weeks||||participants|||Number
1452999|NCT00830375|Primary|Yale Brown Obsessive Compulsive Scale Modified for CB (CB-YBOCS)|The CB-YBOCS is a reliable and valid, 10-item, clinician-administered scale that rates buying symptoms within the last seven days, on a severity scale from 0 to 4 for each item (total scores range from 0 to 40 with higher scores reflecting greater illness severity). Scores ranging from 0 to 10 reflect minimal or mild symptoms; scores from 11 to 20 suggest moderate symptoms; severe symptoms are associated with scores from 21 to 30; and scores greater than 30 reflect extreme buying symptoms|from study start to study end (8-weeks) and is Investigator rated|Reported scores are Mean and standard deviation for Subjects last visit (Week 8 or last-observation carried forward).|||units on a scale||Standard Deviation|Mean
1453000|NCT00830362|Primary|Single Item Craving Test Session Difference Scores|Mean of the difference of Session 1 and Session 2 cocaine craving scores (Session 2-Session 1). Found by using our Single Item Craving (SIC) scale. A study team member asks the participant to verbally report the level of craving they were experiencing using values between 0 and 100, with 0 representing no craving and 100 extreme craving. The difference score was found by subtracting session 1 mean SICs during cue exposure from session 2 mean SICs during cue exposure. Therefore the mean of the difference could have ranged anywhere from -100 to 100. Negative mean difference scores reflect a decrease in craving for cocaine from session 1 (test) to session 2 (retrieval). The lower the mean difference score, the greater the decrease in craving.|Both days of cue exposure||||units on a scale||Standard Error|Mean
1453001|NCT00830336|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.|||ng*h/mL||Standard Deviation|Mean
1453002|NCT00830336|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.|||ng*h/mL||Standard Deviation|Mean
1453003|NCT00830336|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|Samples for two subjects who completed the study were not analyzed per protocol due to emesis during the sample collection period.|||ng/mL||Standard Deviation|Mean
1453004|NCT00830310|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1453005|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Week)|"Treatment nonadherence is measured as a percentage of medications not taken within the past week at time of assessment.~The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||percentage of medications not taken||Standard Error|Mean
1453006|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1453007|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1453011|NCT00830310|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1453012|NCT00830310|Primary|Change in Treatment Non-adherence as Measured by the Tablets Routine Questionnaire (TRQ) (Past Month)|"Treatment non-adherence is measured as a percentage of medications not taken within the past month at time of assessment.~The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence."|From Baseline to 3 months|Number of participants for analysis was based on all available data at the three month time point.|||percentage of medication not taken||Standard Error|Mean
1453013|NCT00830284|Secondary|Safety - Airleak, Cardiac Compromise, Respiratory Acidosis.||4 hours||||Participants|||Count of Participants
1453014|NCT00830284|Primary|PaO2 + PaCO2 of 400 or Higher.||2 hours||||Participants|||Count of Participants
1453015|NCT00830258|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453016|NCT00830258|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453017|NCT00830258|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1453018|NCT00830232|Secondary|Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI||within 24 hours after carotid artery stenting|||||||
1453019|NCT00830232|Secondary|Composite of Any Stroke, Myocardial Infarction or Death||within 30 days after the carotid stenting procedure|||||||
1453020|NCT00830232|Primary|Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.|Bilateral transcranial Doppler scan monitoring of the anterior and middle cerebral arteries was performed using a PMD150-ST3 digital transcranial Doppler pulsed-wave ultrasound scan system (Spencer Technologies, Seattle, Wash) with 2-MHz probes located over the temporal bones above the zygomatic arch. Isolated microembolic signals (MES) were identified from Doppler spectras according to the criteria given by the Consensus Committee of the Ninth International Cerebral Hemodynamic Symposium. If the number of MES was too high to be counted separately, heartbeats with microemboli were counted as microembolic showers. To avoid confusion, MES detected during contrast injection were excluded from the analysis. For analysis purposes, the procedure was divided into the following phases: lesion crossing, filter deployment, IVUS examination, predilation, stent deployment, postdilatation (when applicable), and filter removal.|First 24 hours after implantation of carotid stent||||Micro-emboli||Inter-Quartile Range|Median
1453021|NCT00830219|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453022|NCT00830219|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453023|NCT00830219|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453024|NCT00830206|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.|||ng*h/mL||Standard Deviation|Mean
1453025|NCT00830206|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.|||ng*h/mL||Standard Deviation|Mean
1453026|NCT00830206|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 168 hour period|One subject was excluded from statistical analysis due to emesis during sample collection period.|||ng/mL||Standard Deviation|Mean
1453027|NCT00830167|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453028|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453029|NCT00830167|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety|Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453030|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453031|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453032|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453033|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453034|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453035|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453036|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453037|NCT00830167|Secondary|Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453038|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453039|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453040|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453041|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453042|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453043|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453044|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453045|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453046|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453047|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453048|NCT00830167|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores|FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453049|NCT00830167|Secondary|Change From Baseline in Sleep Quality Score at Endpoint|Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453050|NCT00830167|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Participants|||Number
1453051|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453052|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453053|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453054|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453055|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453056|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453096|NCT00829985|Secondary|Percent of Participants With the Occurrence of Adverse Events (AE)|Percent of participants who experienced at least one adverse event|Participant enrollment to end of study (up to 6 months post-baseline)|Safety population|||percentage of population|||Number
1453057|NCT00830167|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance|MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453058|NCT00830167|Secondary|Percentage of Participants Who Was Categorized as “Improved (Very Much Improved, Much Improved, or a Minimally Improved)” According to the Patient Global Impressions of Change (PGIC)|PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.|Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication.|||Percentage of participants|||Number
1453059|NCT00830167|Primary|Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline|Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain).|Baseline, Week 15 or study discontinuation|The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.|||Scores on a scale||Standard Error|Least Squares Mean
1453060|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453061|NCT00830128|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint|"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453062|NCT00830128|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint|MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night.|Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Paticipants|||Number
1453063|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453064|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453065|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||hours||Standard Deviation|Mean
1453128|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453066|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453067|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453068|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453069|NCT00830128|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint|"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1453070|NCT00830128|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint|"The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit.~Change = mean scores at observation minus mean scores at baseline."|Baseline, Week 52 or Study Discontinuation|All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment.|||mm||Standard Deviation|Mean
1453071|NCT00830128|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Up to 53 weeks|All participants who received at least 1 dose of the study medication.|||Participants|||Number
1453072|NCT00830115|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Participants|||Number
1453073|NCT00830115|Secondary|Assessment of the Efficacy of Pantoprazole at Final Visit|Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|7 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||Participants|||Number
1453074|NCT00830115|Secondary|Physician's Assessment of Painful Swallowing|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1453075|NCT00830115|Secondary|Physician's Assessment of Acid Eructation|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1453076|NCT00830115|Secondary|Physician's Assessment of Heartburn|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1453077|NCT00830115|Secondary|Patient's Assessment of Nausea for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 809~Day 1 = 798~Day 2 = 776~Day 3 = 761~Day 4 = 743~Day 5 = 738~Day 6 = 732"|||Units on a scale||Standard Deviation|Mean
1453129|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453078|NCT00830115|Secondary|Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 798~Day 1 = 782~Day 2 = 769~Day 3 = 759~Day 4 = 752~Day 5 = 739~Day 6 = 738"|||Units on a scale||Standard Deviation|Mean
1453079|NCT00830115|Secondary|Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 887~Day 1 = 867~Day 2 = 846~Day 3 = 823~Day 4 = 801~Day 5 = 784~Day 6 = 773"|||Units on a scale||Standard Deviation|Mean
1453080|NCT00830115|Secondary|Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 903~Day 1 = 891~Day 2 = 877~Day 3 = 843~Day 4 = 823~Day 5 = 791~Day 6 = 781"|||Units on a scale||Standard Deviation|Mean
1453081|NCT00830115|Secondary|Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 908~Day 1 = 906~Day 2 = 890~Day 3 = 876~Day 4 = 861~Day 5 = 842~Day 6 = 834"|||Units on a scale||Standard Deviation|Mean
1453082|NCT00830115|Primary|Physician's Assessment of Sleep Disturbances|Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe|7 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||Units on a scale||Standard Deviation|Mean
1453083|NCT00830115|Primary|Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)|Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 846~Day 1 = 841~Day 2 = 828~Day 3 = 817~Day 4 = 800~Day 5 = 791~Day 6 = 790"|||Units on a scale||Standard Deviation|Mean
1453084|NCT00830115|Primary|Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)|Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts|7 days|"All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~Day 0 = 869~Day 1 = 868~Day 2 = 867~Day 3 = 864~Day 4 = 863~Day 5 = 859~Day 6 = 862"|||Units on a scale||Standard Deviation|Mean
1453085|NCT00830076|Secondary|Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations|Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2||||mg/dL||95% Confidence Interval|Least Squares Mean
1453086|NCT00830076|Secondary|β-cell Sensitivity|"β-cell sensitivity was defined as the incremental post-prandial~4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC."|6 hour post-dose (4 hour postmeal) on Day 2|Beta-cell sensitivity was not calculated for 1 participant following the administration of sitagliptin alone and metformin alone due to missing insulin data.|||(ng/min)/(mg/dL)*10^ -3||95% Confidence Interval|Least Squares Mean
1453087|NCT00830076|Primary|Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations|Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.|6 hours postdose (4 hours postmeal) on Day 2||||picomolar||95% Confidence Interval|Least Squares Mean
1453088|NCT00830037|Secondary|Proteinuria|Proteinuria was estimated using measurements of urinary protein and creatinine before iron administration at baseline and at periodic intervals thereafter. Mean change from baseline log urinary protein/creatinine ratio (g/g) is reported at 2 years.|Baseline, 2 years||||g/g||95% Confidence Interval|Mean
1453089|NCT00830037|Primary|Mean Rate of Decline in mGFR in the Two Groups - Oral and IV Iron|Plasma clearance of iothalamate was measured by administering an IV bolus of 5 mL of iothalamate meglumine and sampling 2 mL of blood at 0, 5, 10, 20, 30, 45, 60, 90, 120, 150, 180, 240, and 300 min after injection. Iothalamate was measured by high-performance liquid chromatography. Plasma clearance was calculated using a two-pool model using validated pharmacokinetic software. The mean modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) in each group (IV iron vs. oral iron) was then calculated after adjustment for baseline log urinary protein/creatinine ratio.|Baseline, 2 years|Modeled iothalamate mGFR slope (e.g., change from baseline to 2 years) was calculated for each group (IV iron vs. oral iron) after adjustment for baseline log urinary protein/creatinine ratio.|||Slope (ml/min per 1.73m2 per year)|||Number
1453090|NCT00830024|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453091|NCT00830024|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453092|NCT00830024|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 72 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1453093|NCT00829998|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453094|NCT00829998|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453095|NCT00829998|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 10 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1453097|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (60 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 60 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Percent antibody binding||95% Confidence Interval|Mean
1453098|NCT00829985|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity (30 Micrograms/mL Cockroach Allergen Extract)|Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from sensitized donor incubated with 30 micrograms/mL of cockroach allergen extract in presence or absence of equal volume of sera from study participants to assess allergen-IgE binding. (Presence of sera from those who previously received allergen-specific immunotherapy, viz., study participants post-baseline, expected to inhibit allergen-IgE complex binding.) This change is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Percent antibody binding||95% Confidence Interval|Mean
1453099|NCT00829985|Secondary|Difference in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. This ratio is an indicator of immune modulation, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Mean
1453100|NCT00829985|Primary|Difference in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 6-months of treatment|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Mean
1453101|NCT00829933|Secondary|Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )||12 weeks|||||||
1453102|NCT00829933|Secondary|Plasma DU-176 Concentration||12 weeks|||||||
1453103|NCT00829933|Secondary|Pharmacodynamic Parameters (PT, PT-INR, and APTT)|PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time|12 weeks|||||||
1453104|NCT00829933|Secondary|Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment||12 weeks|||||||
1453105|NCT00829933|Secondary|Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.||12 weeks|||||||
1453106|NCT00829933|Primary|Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.|The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.|12 weeks|Primary endpoint analyzed for subjects who proceeded to treatment period in FAS.|||percent of subjects with bleeding event||95% Confidence Interval|Number
1453107|NCT00829868|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453108|NCT00829868|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453109|NCT00829868|Primary|Cmax - Maximum Observed Concentration|Bioequivalence based on Cmax|Blood samples collected over 12 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1453110|NCT00829829|Secondary|Number of Gout Flare Days With Participant’s Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16)|Participants were asked to complete a telephone diary by calling the IVRS daily beginning at the baseline visit (Day 1) through the follow-up visit (Day 141) and reported their general well-being, gout symptoms, and weekly study drug administrations. At the onset of pain from a gout flare, participants were to answer additional diary questions regarding their gout flare and had to continue daily flare assessments until they reported the flare had ended. If a flare occurred just prior to the follow-up visit (Day 141), participants were to continue completing the daily diary until the flare resolved. Gout flare pain was assessed on a scale from 0 to 10 (with 0=no pain and 10=severe pain) within the past 24 hours.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||Gout flare days||Standard Deviation|Mean
1453111|NCT00829829|Secondary|Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flare days per participant was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||Gout flare Days||Standard Deviation|Mean
1453130|NCT00829738|Secondary|Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453112|NCT00829829|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||percentage of participants|||Number
1453113|NCT00829829|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare was reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||percentage of participants|||Number
1453114|NCT00829829|Secondary|Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16)|Modified gout flare was defined using modified definition of a gout flare as participant-reported articular pain typical of a gout attack that was deemed to require treatment with anti-inflammatory therapy. Number of modified gout flares per participant were reported for this outcome measure.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IVRS at randomization (as randomized).|||modified gout flares||Standard Deviation|Mean
1453115|NCT00829829|Primary|Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)|A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 112 were counted, regardless whether the flares occurred during the treatment period or not.|Day 1 to Day 112 (Week 16)|Full analysis set (FAS) that included all randomized participants who received any study medication and was based on the treatment allocated by IIVRS at randomization (as randomized).|||Number of Gout flares per participant||Standard Deviation|Mean
1453116|NCT00829790|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1453117|NCT00829790|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1453118|NCT00829790|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1453119|NCT00829764|Primary|AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1453120|NCT00829764|Primary|AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
1453121|NCT00829764|Primary|Cmax = Maximum Observed Concentration.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
1453122|NCT00829738|Secondary|Assessment of the Tolerability of Pantoprazole at Final Visit|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
1453123|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
1453124|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Constipation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453125|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453126|NCT00829738|Secondary|Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453127|NCT00829738|Secondary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
1453131|NCT00829738|Primary|Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms|Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory|14 days|Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat|||percentage of participants|||Number
1453132|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453133|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453134|NCT00829738|Primary|Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn|Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe|14 days|Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat|||units on a scale||Standard Deviation|Mean
1453135|NCT00829712|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453136|NCT00829712|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453137|NCT00829712|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453138|NCT00829686|Secondary|Recurrence Rates|recurrence of abscess in previous or new location within 30 days|30 days||||participants|||Number
1453139|NCT00829686|Primary|Clinical Improvement at 7 Days After Incision and Drainage|improving wound without evidence of fever, worsening cellulitis or induration|7 days||||participants|||Number
1453140|NCT00829673|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453141|NCT00829673|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453142|NCT00829673|Primary|Cmax (Maximum Observed Concentration)|Bioequivalence based on Cmax.|Blood samples collected over a 16 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453143|NCT00829621|Primary|Presence of BMP-2 in Effluent Collected in IVAC Canister|Presence of BMP-2 in effluent collected in IVAC canister|12-hours, 24-hours, 36-hours, and 48-hours after IVAC application||||participants|||Number
1453144|NCT00829530|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours)for Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453145|NCT00829530|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453146|NCT00829530|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453147|NCT00829530|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453148|NCT00829530|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453149|NCT00829504|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)|Bioequivalence based on AUC0-inf.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453150|NCT00829504|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)|Bioequivalence based on AUC0-t.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453151|NCT00829504|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)|Bioequivalence based on Cmax.|Blood samples collected over a 24 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453152|NCT00829452|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time of 72 Hours) for Ramiprilat.|Informational comparison of AUc0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453153|NCT00829452|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453154|NCT00829452|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) for Ramipril.|Bioequivalence based on AUC0-inf.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453155|NCT00829452|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) for Ramipril.|Bioequivalence based on AUC0-t.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453156|NCT00829452|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)for Ramipril.|Bioequivalence based on Cmax.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453157|NCT00829439|Primary|Maximum Dose of Levodopa/Carbidopa That Can be Tolerated (Without Any Dose Limiting Toxicity) by at Least 3 Subjects.||1 week||||mg/kg/day|||Number
1453158|NCT00829426|Primary|Bioequivalence Based on AUC0-t|AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration|Blood samples collected over 72 hour period||||ng*h/mL||Standard Deviation|Mean
1453159|NCT00829426|Primary|Bioequivalence Based on AUC0-inf|AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)|Blood samples collected over 72 hour period||||ng*h/mL||Standard Deviation|Mean
1453160|NCT00829426|Primary|Bioequivalence Based on Cmax|Cmax - Maximum Observed Concentration|Blood samples collected over 72 hour period||||ng/mL||Standard Deviation|Mean
1453161|NCT00829413|Secondary|Inter-reader Agreement|Kappa statistic based on assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately and computation for the percentage agreement within two categories: “3 out of 3 readers agree” and “2 out of 3 readers agree”.|24 hours to 6 months||||Percentage of agreement|||Number
1453162|NCT00829413|Secondary|Specific Diagnosis of Benign FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Among the 140 ITD participants with benign lesions based on the truth standard, only 91 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 140 ITD participants with benign lesions based on the truth standard, only 91 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.|||Benign lesions|Benign lesions to be characterized||Number
1453163|NCT00829413|Secondary|Specific Diagnosis of Malignant FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 119 ITD participants with malignant lesions based on the truth standard, only 94 participants (lesions) were characterized as either hepatocellular carcinoma (HCC) lesions or metastatic lesions.|||Malignant lesions|Malignant lesions to be characterized||Number
1453164|NCT00829413|Secondary|Negative Predictive Value [NPV]: Percentage of True Negative Lesions Among All Benign Lesions Per Ultrasound|"Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100."|24 hours to 6 months|Among the 259 ITD participants, the number of participants (lesions) assessed as benign varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent negative lesions by ultrasound|Negative lesions|95% Confidence Interval|Number
1453165|NCT00829413|Secondary|Positive Predictive Value [PPV]: Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound|"Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up.~Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100."|24 hours to 6 months|Among the 259 ITD participants, the overall number of participants (lesions) assessed as malignant varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent positive lesions by ultrasound|Positive lesions|95% Confidence Interval|Number
1453166|NCT00829413|Secondary|Accuracy: Percentage of True Positive and True Negative Among All Lesions|"Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population.~Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and truth standard.~True negative: subject with a target lesion characterized as benign by both ultrasonography and truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100."|24 hours to 6 months|259 participants in the ITD population|||Percent true positive and negative lesio|Total lesions|95% Confidence Interval|Number
1453208|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 1|1 year survival was defined as the percentage of participants alive 1 year after starting treatment. The results reported are from the final analysis.|Year 1|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants||95% Confidence Interval|Number
1453167|NCT00829413|Primary|Specificity: Percentage of True Negative Lesions Among All Benign Lesions Per Truth Standard’|"Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population.~Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and truth standard.~Among the 259 ITD participants, only 140 participants (lesions) were benign based on the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100."|24 hours to 6 months|Among the 259 ITD participants, only 140 participants (lesions) were benign based on the truth standard and were were included for specificty.|||Percentage of true benign lesions|Benign lesions|95% Confidence Interval|Number
1453168|NCT00829413|Primary|Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard|"Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs) using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-diagnose (ITD) population. Unit of analysis was the lesion, equivalent to subject, since each subject had a single lesion to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: CE-CT and/or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100"|24 hours to 6 months|Among 259 ITD subjects, 119 were malignant by truth standard and were included for sensitivity.|||Percentage of true positive lesions|Malignant lesions|95% Confidence Interval|Number
1453169|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 36 weeks post-baseline comparing CBT to Education.~0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed"|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36 week post treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
1453170|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 36 weeks post-baseline comparing CBT to Education.~Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
1453171|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 36 weeks post-baseline comparing CBT and Educational arms~Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable); the higher the number, the greater percieved pain intensity."|baseline to 36 weeks post-baseline [follow-up]|Not everyone that has baseline data completed 36-week follow up treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
1453172|NCT00829387|Secondary|Beck Depression Inventory (BDI)|"Estimated mean change in depressive symptoms from baseline to 12 weeks post-baseline combaring CBT and ED.~0 (do not endorse) to 3 (highly endorse). no/minimal depressive symptoms =<10; mild-moderate depressive symptoms = 10-18; moderate-severe depressive symptoms = 19-29 severe depressive symptoms = 30-63. The higher the score, the more depressive symptoms endorsed."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment; making the number of participants analyzed differant than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
1453173|NCT00829387|Secondary|The Interference Subscale of the Multidimensional Pain Inventory (MPI)|"Secondary outcome is the estimated mean change in pain interference from baseline to 12 weeks post-baseline comparing CBT to Education.~Pain Interference at the time of assessment; 0 = no interference to 6 = extreme interference. The higher the average number calculated for the subscale, the higher the perceived interference pain has on vocational, social/recreational, and family/martital functioning."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that has baseline data completed 12-week post treatment data; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
1453174|NCT00829387|Primary|Numeric Rating Scale (NRS) Pain Intensity|"Primary outcome is the estimated mean change in pain intensity ratings from baseline to 12 weeks post-baseline comparing CBT and Educational arms~Average pain intensity rating over the last 7 days; 0 (no pain at all) to 10 (worst pain imaginable). The higher the score, the more perceived pain a participant reported."|baseline to 12 weeks post-baseline [post-treatment]|Not everyone that completed baseline data completed 12 week post treatment assessments; making the number of participants analyzed different than reported for baseline data only.|||units on a scale||95% Confidence Interval|Mean
1453175|NCT00829309|Primary|AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)|Bioequivalence based on AUC0-t|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng*h/mL||Standard Deviation|Mean
1453176|NCT00829309|Primary|AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)|Bioequivalence based on AUC0-inf|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis. Data from one subject could not be included in the AUC0-inf calculation for Pravachol®.|||ng*h/mL||Standard Deviation|Mean
1453177|NCT00829309|Primary|Cmax - Maximum Observed Concentration - Pravastatin in Plasma|Bioequivalence based on Cmax|Blood samples collected over 16 hour period|Data from all subjects who completed the study were included in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1453178|NCT00829296|Secondary|Change in Pulse Pressure Amplification|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure).|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||ratio||Standard Deviation|Mean
1453179|NCT00829296|Secondary|Change in Augmentation Index|Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||percent (%)||Standard Deviation|Mean
1453180|NCT00829296|Secondary|Change in Pulse Wave Velocity (PWV)|To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||m/s||Standard Deviation|Mean
1453181|NCT00829296|Primary|Change in Central Systolic Blood Pressure (SBP)|Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.|Baseline and 26 Weeks|Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study.|||mmHg||Standard Deviation|Mean
1453182|NCT00829283|Secondary|BMI|The body mass index is a value derived from the mass and height of an individual. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2.|12 months follow-up post-treatment||||kg/m^2||Standard Deviation|Mean
1453183|NCT00829283|Primary|Number of Subjects Who Reached Binge Eating Remission|Binge Remission (abstinence from binge eating)|12 months follow-up||||participants|||Number
1453184|NCT00829244|Secondary|Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome|Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).|up to 9 month (following the end of treatment)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||participants|||Number
1453185|NCT00829244|Secondary|Number of Participants With OHSS|OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.|Start of treatment until Day 15-20 Post-hCG|Safety population included all the participants who were randomized.|||participants|||Number
1453186|NCT00829244|Secondary|Percentage of Participants With Clinical Pregnancy|Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||percentage of participants|||Number
1453187|NCT00829244|Secondary|Serum Progesterone (P4) Levels||End of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||nmol/L||Standard Deviation|Mean
1453188|NCT00829244|Secondary|Number of Participants With Multiple Pregnancies|Multiple pregnancy was defined as 2 or more fetal hearts with activity.|Day 35-42 Post-hCG|The modified ITT population. Number of participants analyzed (N) signifies those participants who were evaluated for this outcome measure.|||participants|||Number
1453189|NCT00829244|Secondary|Implantation Rate|Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||percent sacs per embryo||Standard Deviation|Mean
1453190|NCT00829244|Secondary|Number of Participants With Fetal Sacs and Fetal Hearts|Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.|Day 35-42 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||participants|||Number
1453191|NCT00829244|Secondary|Percentage of Participants With Biochemical Pregnancies|Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.|Start of treatment until Day 15-20 Post-hCG|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||percentage of participants|||Number
1453192|NCT00829244|Secondary|Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment|Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.|Start of treatment until Day 15-20 post-hCG|All the randomized participants were analyzed for this outcome measure (N=200).|||Participants|||Number
1453193|NCT00829244|Secondary|Total Number of GONAL-f® Stimulation Treatment Days||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||days||Standard Deviation|Mean
1453194|NCT00829244|Secondary|Mean GONAL-f® Daily Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||IU||Standard Deviation|Mean
1453195|NCT00829244|Secondary|Total GONAL-f® Dose||Start of treatment until end of stimulation cycle (approximately 28 days)|The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||IU||Standard Deviation|Mean
1453196|NCT00829244|Primary|Number of Oocytes Retrieved Per Participant|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)|The modified Intention-To-Treat (ITT) population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.|||oocytes||Standard Deviation|Mean
1453197|NCT00829179|Primary|Change in Exhaled Nitric Oxide From Baseline to Week 12|The primary outcome measure was the change in exhaled nitric oxide levels between baseline and week 12. 12 week value minus baseline value. (Baseline was -1 week, ie 1 week prior to the start of study drug)|13 weeks||||parts per billion (ppb)||Standard Deviation|Mean
1453198|NCT00829166|Secondary|Time to Symptom Progression|"Time to symptom progression was defined as the time from randomization to the first documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the FACT-B questionnaire with the TOI-PFB subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (BCS). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The median time to symptom progression was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.|||Months||95% Confidence Interval|Median
1453199|NCT00829166|Secondary|Percentage of Participants With Symptom Progression|"Symptom progression was defined as the documentation of a >/= 5-point decrease from baseline in the scoring of responses as measured by the Functional Assessment of Cancer Therapy-for participants with Breast Cancer (FACT-B) questionnaire with the Trial Outcomes Index-Physical/Functional/Breast (TOI-PFB) subscale. The FACT-B TOI-PFB subscale contained 24 items from 3 subsections of the FACT-B questionnaire: Physical well-being, functional well-being, and additional concerns for breast cancer participants (breast cancer subscale [BCS]). All items in the questionnaire were rated by the participant on a 5-point scale ranging from 0 (not at all) to 4 (very much). The total score ranged from 0 to 96 with higher score indicating better perceived quality of life. The percentage of participants with symptom progression was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only female participants with a Baseline assessment and at least 1 follow-up assessment were included in the analysis.|||percentage of participants|||Number
1453200|NCT00829166|Secondary|Time to Treatment Failure|"Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued with treatment failure date as the later of the 2 discontinuation dates. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The median time to treatment failure was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
1453209|NCT00829166|Primary|Overall Survival: Final Analysis|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
1453201|NCT00829166|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure was defined as discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause. For Lapatinib + Capecitabine arm, a participant was considered as treatment failure only if both drugs were discontinued. For TLs, PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of participants with treatment failure was reported."|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
1453202|NCT00829166|Secondary|Percentage of Participants With Clinical Benefit as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart. For TLs, CR: disappearance of all TLs; PR: >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; PD: >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions; and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For non-TLs, CR: disappearance of all non-TLs; PR/SD: persistence of 1 or more non-TLs; and PD: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants without a post-baseline tumor assessment were considered non-responders. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at Baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1453203|NCT00829166|Secondary|Duration of Objective Response (DOR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier. OR was defined as a CR or PR determined on 2 consecutive tumor assessments at least 4 weeks apart. For TLs, CR was defined as the disappearance of all TLs; PR was defined as >/=30% decrease in the SLD of TLs, taking as reference the baseline SLD; and PD was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, CR was defined as the disappearance of all non-TLs; PR was defined as the persistence of 1 or more non-TLs; and PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
1453204|NCT00829166|Secondary|Percentage of Participants With Objective Response (OR) as Assessed by an IRC|Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as >/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1453205|NCT00829166|Secondary|PFS as Assessed by the Investigator|Tumor response was assessed by the investigator according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS was defined as the time from randomization to first documented PD by Investigator or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
1453206|NCT00829166|Secondary|Percentage of Participants With PD or Death as Assessed by the Investigator|PD was assessed by the investigator using modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. PD for TLs was defined as >/=20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. The percentage of participants who died or experienced PD by Investigator was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
1453207|NCT00829166|Primary|Percentage of Participants Who Were Alive at Year 2|2 year survival was defined as the percentage of participants alive 2 years after starting treatment. The results reported are from the final analysis.|Year 2|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants||95% Confidence Interval|Number
1453210|NCT00829166|Primary|Percentage of Participants Who Died: Final Analysis|The percentage of participants who died from any cause was reported. The results reported are from the final analysis. The final analysis is descriptive.|From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
1453211|NCT00829166|Primary|Overall Survival: Second Interim Analysis (Co-primary Endpoint)|OS was defined as the time from the date of randomization to the date of death from any cause. The median duration of OS was estimated using Kaplan-Meier method. The 95% CI was computed using the method of Brookmeyer and Crowley. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
1453212|NCT00829166|Primary|Percentage of Participants Who Died: Second Interim Analysis|The percentage of participants who died from any cause was reported. The results are reported from second interim analysis, which deemed to be the confirmatory.|From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
1453213|NCT00829166|Primary|Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint)|Tumor response was assessed by an IRC according to modified RECIST. All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs (on the basis of their size and their suitability for accurate repeated measurements either by imaging or clinically) and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. All other lesions were identified as non-TLs and recorded at baseline. PD for TLs: >/= 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs: appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. PFS: time from randomization to first documented PD by IRC or death from any cause (whichever occurred earlier). The median duration of PFS was estimated using Kaplan-Meier method. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||Months||95% Confidence Interval|Median
1453214|NCT00829166|Primary|Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC)|PD was assessed by an IRC using modified Response Evaluation Criteria in Solid Tumors (RECIST). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as target lesions (TLs) and recorded at baseline. TLs should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements either by imaging or clinically. A sum of the longest diameter for all TLs was calculated as baseline sum longest diameter (SLD). All other lesions (or sites of disease) should be identified as non-TLs and recorded at baseline. PD for TLs was defined as greater than or equal to (>/=) 20 percent (%) increase in SLD, taking as reference smallest SLD recorded since treatment started or appearance of 1 or more new lesions. PD for non-TLs was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Percentage of Participants with PD by IRC or death from any cause was reported.|From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)|ITT population included all randomized participants on the basis of the treatment assigned at randomization.|||percentage of participants|||Number
1453215|NCT00829049|Secondary|Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16|Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percent Change||Full Range|Median
1453216|NCT00829049|Secondary|Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12|Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.|Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percentage of patients|||Number
1453217|NCT00829049|Secondary|Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16|Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.|Week 16|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percentage of patients|||Number
1453218|NCT00829049|Primary|Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12|Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).|Baseline, Week 12|Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.|||Percent Change||Full Range|Median
1453219|NCT00829036|Primary|Mean Percent (Prototype / Baseline) Time|The outcome measure for each subject is the mean of the (Prototype Time / Baseline Time) across 12 trials. The outcome measure for the experiment is the mean of 24 individual subject mean scores. This mean outcome measure is expressed as a percentage of the mean Baseline Time, where improved performance is represented by a percentage that is less than 100 percent of the Baseline Time. The lower the percentage, the better the performance improvement.|2 hours|Power Analysis: Using Repeated Measures ANOVA for the 24 participants assuming a minimum correlation between repeated measures of .7, we chose our analyses will be sensitive to a medium between factor effect size of f=.33 with power set to .80 and alpha level set to .05.|||Percentage of Baseline Performance Time||Standard Deviation|Mean
1453220|NCT00829010|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
1453221|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post Synflorix booster vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
1453222|NCT00829010|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post-primary vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented.|||Participants|||Count of Participants
1453223|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:~drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
1453224|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
1453225|NCT00829010|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).|"General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3:~drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination."|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
1453226|NCT00829010|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre.|During the 4-day (Days 0-3) post-primary vaccination period across doses|The Total Vaccinated cohort included all subjects who received at least one vaccine dose administration, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
1453227|NCT00829010|Secondary|Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs|Acquisition of new H. influenza* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented|||Participants|||Count of Participants
1453254|NCT00828984|Secondary|Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on mucosal epithelial proliferation (Ki-67)|6 months - baseline|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups.|||ng/ml||Standard Deviation|Mean
1453228|NCT00829010|Secondary|Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.|Positive cultures of H. influenza* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age). *Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented|||Swabs|||Number
1453229|NCT00829010|Secondary|Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples|Salivary antibodies against selected common bacterial protein antigens. Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva. Salivary samples were sent to RMPRU (or GSK Biologicals’ designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C. The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.|up to study end at Month 23 (24-27 months of age)|The Total Vaccinated cohort included all subjects with at least one vaccine dose administration documented|||U/mL||95% Confidence Interval|Geometric Mean
1453230|NCT00829010|Secondary|Concentrations of Antibodies Against Measles|Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.|1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1453231|NCT00829010|Secondary|Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.|Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL). The cut-off of the assay is 20 U/mL. Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.|1 month after the administration of the second vaccine dose (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||U/mL||95% Confidence Interval|Geometric Mean
1453232|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.|"Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL.~As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||mIU/mL||95% Confidence Interval|Geometric Mean
1453233|NCT00829010|Secondary|Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA|"Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL.~As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis"|1 month following primary immunization (at Month 3)|According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
1453234|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month after the booster vaccination (at Month 15)|The ATP cohort for immunogenicity at 15 -18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||µg/mL||95% Confidence Interval|Geometric Mean
1453235|NCT00829010|Secondary|Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)|Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL). The cut-off of the assay is 0.15 µg/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1453236|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The ATP cohort for immunogenicityat 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1453335|NCT00828178|Primary|Effect on Brachial Artery Flow Dilation by Omega-3 Versus Placebo.|The assessment measured mean brachial artery diameter at pre-treatment(baseline) and post-treatment (after 12 weeks).|12 weeks|Patients who successfully completed the trial.|||cm||Standard Deviation|Mean
1453237|NCT00829010|Secondary|Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 15 EL.U/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1453238|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL). The cut-off of the assay is 0.1IU/mL.|1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)|The According-To-Protocol cohort for immunogenicity at 15-18 months included evaluable subjects from the ATP cohort for Immunogenicity who received the DTPw-HBV/Hib vaccine and for whom assay results were available for antibodies against at least 1 vaccine antigen component after this booster dose vaccine.|||IU/mL||95% Confidence Interval|Geometric Mean
1453239|NCT00829010|Secondary|Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).|Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.|1 month following primary immunization (at Month 3)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
1453240|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA.|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1453241|NCT00829010|Secondary|Concentrations of Antibodies Against Protein D (PD) by ELISA|Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay was 100 EL.U/mL. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1453242|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1453243|NCT00829010|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|ATP cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1453244|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1453255|NCT00828984|Secondary|Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|To determine the effect of PEG 3350 on aberrant crypt foci (ACF) number and to compare the reduction in ACF number between the low dose (8g PEG 3350 / day) and higher dose (17g PEG 3350 / day) groups|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||Aberrant Crypt Foci||Standard Deviation|Mean
1453245|NCT00829010|Secondary|Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1453246|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1453247|NCT00829010|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titer of 8.|At Month 3 and at Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1453248|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups. The cut-off of the assay is 0.05 µg/mL.|up to study end at Month 23 (24-27 months of age)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
1453249|NCT00829010|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.|Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group. The cut-off of the assay is 0.05 µg/mL.|At Month 3 and Month 9|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||µg/ml||95% Confidence Interval|Geometric Mean
1453250|NCT00829010|Primary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).|Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)|The According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post dose II or III, as applicable, or after booster vaccination.|||Participants|||Count of Participants
1453251|NCT00828984|Secondary|Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
1453252|NCT00828984|Secondary|Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies||6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
1453253|NCT00828984|Secondary|Change in Mucosal Apoptosis (Cleaved Caspase-3) as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies|Change in activated caspase-3 (apoptosis) expression as measured in endoscopically normal (non-ACF) mucosal biopsies|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
1454251|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Week 12 for On-ART Participants|Results reported are for HIV-1 RNA at week 12 for on-ART participants.|At week 12|Analysis is based on all on-ART participants with HIV-1 RNA data at week 12.|||participants|||Number
1453256|NCT00828984|Primary|Difference (After Treatment Minus Before Treatment) of EGFR Expression|Evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8g or 17g/day for six months) versus placebo on EGFR expression.|6 months - baseline|The study population includes men and women of all races and ethnicities who are scheduled to undergo colonoscopy for a history of colonic neoplasia (within the past 6 years of either colonic adenoma ≥ 5 mm or carcinoma).|||ng/ml||Standard Deviation|Mean
1453257|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants|||Number
1453258|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants|||Number
1453259|NCT00828945|Primary|Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8|Participants with “Yes” or “No” responses to a question which stated “Have you reached your target LDL-cholesterol level?”. LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants|||Number
1453260|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453261|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453262|NCT00828945|Primary|Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8|LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453263|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453264|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Month 6|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453265|NCT00828945|Primary|Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8|Participants with “Yes” response to a question which stated “Have you been taking at least 90% of your medication for hyperlipidemia?”.|Week 8|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453266|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12|Participants with “Yes” response to a question which stated “The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?”.|Month 12|The FAS included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453267|NCT00828945|Primary|Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12|Participants with “Yes” response to a question which stated “The self-test have increased my motivation for taking my medication for hyperlipidemia?”. The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test.|Month 12|The Full Analysis Set (FAS) included all enrolled participants who met all inclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
1453268|NCT00828841|Secondary|Overall Survival by Histology||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Subjects were stratified by histology prior to randomization to a treatment arm.|||Months||95% Confidence Interval|Median
1453269|NCT00828841|Secondary|1-year Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.||||percentage of participants||95% Confidence Interval|Number
1453270|NCT00828841|Primary|Overall Survival by Treatment Arm||Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.|Two subjects in Arm A were censored due to negative event intervals.|||Months||95% Confidence Interval|Median
1453271|NCT00828750|Secondary|Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy|Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS|||percentage of participants|||Number
1453272|NCT00828750|Secondary|Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication|Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis.|||percentage of participants|||Number
1453273|NCT00828750|Secondary|Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication|Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants.|||percentage of participants|||Number
1453274|NCT00828750|Secondary|Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals|Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)|FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants.|||weeks||Full Range|Median
1453275|NCT00828750|Secondary|Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)|Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants.|||percentage of participants|||Number
1453276|NCT00828750|Secondary|Median Platelet Counts|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.|||Gi/L||Full Range|Median
1453277|NCT00828750|Secondary|Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L|Platelet counts were measured by blood draw.|Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)|Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.|||percentage of participants|||Number
1453278|NCT00828750|Primary|Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.|From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)|Safety Population (SP): all participants who received at least one dose of study medication|||participants|||Number
1453279|NCT00828711|Secondary|Time to Onset of Active Labor||Interval from study drug administration to active labor (average 12 hours)|Kaplan-Meier Estimates for Time to Onset of Active Labor presented (Modified Intention-to-Treat population). Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery (Censored subjects = MVI 100: 5; MVI 150: 7; MVI 200: 8)|||minutes||95% Confidence Interval|Median
1453280|NCT00828711|Secondary|Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid.|The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug.|From study drug insertion up to 2 hours post study drug removal|The plan was to enrol 24 subjects to the pharmacokinetic (PK) arm of the study. Only 3 subjects enrolled in the PK arm; there were too few subjects and too few samples available. Due to insufficient data, no statistical analysis was possible. Only misoprostol acid levels for each blood sampling timepoint for each subject was determined.|||PK Parameters|||Number
1453281|NCT00828711|Secondary|Use of Oxytocin|Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure.|At least 30 minutes after study drug removal|Percentage of subjects who required pre-delivery oxytocin is presented (Modified Intention-to-Treat population).|||percentage of participants||95% Confidence Interval|Number
1453282|NCT00828711|Secondary|Cervical Ripening Using Composite Measure of Success|"Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration:~Increase from baseline in modified Bishop score ≥3; or~Achievement of modified Bishop score of ≥6; or~Vaginal delivery."|12 hours after insertion of drug|Percentage of subjects with cervical ripening success at 12 hours is presented (Modified Intention-to-Treat population).|||percentage of participants||95% Confidence Interval|Number
1453283|NCT00828711|Secondary|Proportion of Cesarean Delivery||Interval from study drug administration to cesarean delivery (average 24 hours)|Percentage of subjects who had a cesarean delivery during the first hospitalization (safety population) is presented.|||percentage of participants||95% Confidence Interval|Number
1453349|NCT00828061|Primary|Fold Change From Baseline at Hour 8 in Interleukin 5 (IL-5) Concentration|Comparison of the Change in Allergen-induced Interleukin 5 (IL-5) as Measured in Nasal Exudates After a Single Dose of Low or High Dose of Oral Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients as Treated|||Fold Change||95% Confidence Interval|Geometric Mean
1453284|NCT00828711|Secondary|Rate of Adverse Events|All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events.|From study drug administration to hospital discharge (approximately 48 - 72 hours)|The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.|||percentage of participants|||Number
1453285|NCT00828711|Secondary|Time to Vaginal Delivery||Interval from study drug administration to delivery (average 24 hours)|Kaplan-Meier Estimates are based on Modified Intention-to-Treat (MITT) population.Subjects who had a cesarean, discharged prior to delivery or withdrew consent during first hospitalization were censored (MVI 100: 37, MVI 150: 39, MVI 200: 31) using the longest time interval from study drug administration to cesarean or to Labor & Delivery discharge|||minutes||95% Confidence Interval|Median
1453286|NCT00828711|Primary|Proportion of Women Delivering Vaginally||Interval from study drug administration to 24 hours|Analysis based on Modified Intention-to-Treat (MITT) population who delivered vaginally. Percentage of subjects who delivered vaginally is presented.|||percentage of participants||95% Confidence Interval|Number
1453287|NCT00828568|Primary|Number of Participants in Intention-to-treat (ITT)Population With 100% Clearance of Actinic Keratosis (AK) Lesions Identified at Baseline|"Uses ITT population. Three patients (1 Imiquimod 5% Taro and 2 Imiquimod Aldara) did not have a follow-up visit after dosing and were excluded from ITT. Three patients (2 Imiquimod 5% Taro and 1 Imiquimod Aldara) were not evaluable at the 24-week visit and were not in the analysis.~Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Intention to Treat (ITT) Population|||Participants|||Number
1453288|NCT00828568|Secondary|Patients Reporting at Least One Adverse Event|For all patients who received a single dose, adverse events were collected at each follow-up visit. Any patient reporting a single or multiple adverse events at any visit was conisdered to have had at least one adverse event.|24 weeks|Safety group includes all patients who received a single dose|||Participants|||Number
1453289|NCT00828568|Primary|Number of Participants With 100% Clearance of Actinic Keratosis Lesions: Comparison of Taro Imiquimod 5% and Aldara-Imiquimod 5%|"Uses per protocol (PP) population.~Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions."|24 weeks|Per Protocol (PP) population|||Participants|||Number
1453290|NCT00828542|Secondary|Maternal (Clinical and Metabolic) and Neonatal (Clinical) Safety Regarding the Use of the Etonogestrel Implant During the Immediate Postpartum Period and the First 12 Weeks Postpartum|Evaluation during the immediate postpartum period was performed at the hospital 24–48 h after delivery, in the morning and after a 12-h fast. Women and newborns were both weighed (Kg), and the blood pressure (mmHg), waist circumference (WC) (cm) and height (m) of the women were each measured by the same observer. Peripheral blood samples (20 mL) were collected and processed within 2 h after being collected. After clotting the serum, samples were centrifuged at room temperature for 10 min, and the sera were stored at −80°C until they were used for the simultaneous determination of all variables except for the complete blood count, which was performed before clotting. The following variables were analyzed: fasting serum glucose; total cholesterol (TC), high density lipoprotein (HDL) cholesterol, and triglycerides (TG), and low density lipoprotein (LDL) cholesterol|12 weeks|||||||
1453291|NCT00828542|Primary|Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks|"Activated protein C (APC) resistance is the most important marker of coagulation system in women using hormonal contraceptive methods.~APC resistance was determined by testing the effect of APC on the endogenous thrombin potential (ETP) using the Calibrated Automated Thrombogram® (CAT) assay. The sensitivity ratio or APC (APCsr) of each plasma sample was determined in the presence or absence of approximately 4 nM APC (Enzyme Research Laboratories, Swansea, United Kingdom). The APC concentration was adjusted to maintain the residual thrombin generation activity in normal pooled plasma at approximately 10%. Normal pooled plasma was run in parallel on each plate.~The normalized ratio (nAPCsr) was determined by dividing the APCsr of an individual sample by the APCsr of the pooled plasma.~Thus, nAPCsr >1.0 indicated APC resistance."|12 weeks||||ratio||Standard Deviation|Mean
1453292|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before the 13th acupuncture treatment|This was the number of participants who continued to, and completed, Series 2 of the treatments|||units on a scale||Standard Deviation|Mean
1453293|NCT00828516|Primary|Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)|MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.|Before 7th acupuncture treatment|All participants completing 6 acupuncture treatments were analysed|||units on a scale||Standard Deviation|Mean
1453294|NCT00828464|Secondary|Change in Subject’s Visual Analogue Assessment Scale From Baseline to Day 15|Mean change in subject’s visual analogue assessment scale from baseline to day 15. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 15|ITT|||Units on a scale||Standard Deviation|Mean
1453321|NCT00828204|Other Pre-specified|Mean Pain Score After Injection|Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).|Day 1, Day 8, Day 15, Day 22|Participants in the Main and Initial Subsets who received at least 1 dose of Avonex injection using the Avonex single-use autoinjector. Missing data were not imputed.|||scores on a scale||Standard Deviation|Mean
1453295|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI)for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
1453296|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Wrists.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
1453297|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
1453298|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Back of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
1453299|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 15 with at least a 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
1453300|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Palm of Hands|"Proportion of Subjects at Day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Palm of Hands.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
1453301|NCT00828464|Secondary|Proportion of Subjects With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
1453302|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline - Fingers|"Proportion of Subjects at day 15 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Fingers.~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
1453303|NCT00828464|Secondary|Proportion of Subjects at Day 8 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of Subjects at day 8 with at least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips~The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 8|ITT|||Percentage of Participants|||Number
1453304|NCT00828464|Secondary|Proportion of Subjects at Day 15 With at Least 1-Grade Improvement In the Hand Eczema Severity Index Score (HESI) for All Symptoms Present at Baseline Finger Tips|"Proportion of subjects at day 15 with at least 1-Grade improvement in the Hand Eczema Severity Index Score (HESI) for all symptoms present at baseline - Finger Tips. The proportion of participants is being reported as a percentage of participants.~Each hand was divided into five areas [fingertips, fingers (except the tips), palms, back of hands and wrists]. For each of these areas the intensity of the 6 following clinical signs: erythema, induration, papulation, vesicles, fissuring, scaling and oedema was graded as follows: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe."|Baseline, Day 15|ITT|||Percentage of Participants|||Number
1453305|NCT00828464|Secondary|Change in Subject’s Visual Analogue Assessment Scale|Mean change in subject’s visual analogue assessment scale from baseline to day 8. At each visit, the subject is requested to rate the changes in their skin on the hands on a 1 to 10 scale with 0 being poor and 10 being excellent.|Baseline, Day 8|ITT. Twenty-nine of the 30 subjects enrolled on this study had results for this endpoint on day 8. Thirty of the 30 subjects enrolled had results for this same assessment at the day 15 visit.|||Units on a scale||Standard Deviation|Mean
1453306|NCT00828464|Primary|Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score|"Proportion of Subjects with at least a 1-Grade Improvement from Baseline to Day 15 In Investigator's Static Global Assessment Score (ISGA) - Chronic Hand Dermatitis Please note that the proportion of participants is being reported as a percentage of participants.~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 15|Intent-to-treat (ITT).|||Percentage of Participants|||Number
1453307|NCT00828464|Secondary|Proportion of Subjects Who Achieve at Least a 1-grade Improvement Based on the ISGA at Day 8.|"Please note that the proportion of participants is being reported as a percentage of participants.~Investigator's Static Global Assessment Score (ISGA) At least 1-grade improvement (%) at Day 8~ISGA grades:~Score = 0 (Clear) Score = 1 (Almost Clear) Score = 2 (Mild) Score = 3 (Moderate) Score = 4 (Severe)"|Baseline, Day 8|ITT|||Percentage of Participants|||Number
1453308|NCT00828451|Secondary|EGF Gene Sequencing|Identification of computationally predicted functional variants in EGF gene|Sampling occurred on average day of life 9 with a range from day of life 7 to 21|29 subjects were enrolled; 11 did not complete the study and were not analyzed|||percentage of participants with variant|||Number
1453309|NCT00828451|Primary|Urinary EGF Protein Levels|Urinary EGF protein levels obtained from free flowing urine samples retrieved from subject diaper were analyzed by commercially available EGF ELISA kit (R &D systems Inc). EGF protein levels were normalized to milligrams of creatinine in urine, and expressed as nanograms of EGF protein per milligram of urinary creatinine.|Sampling occurred on average day of life 9 with a range from day of life 7 to 21|29 subjects were enrolled; 11 did not complete the study and were not analyzed|||nanograms of EGF/mg of creatinine||Full Range|Median
1453310|NCT00828451|Primary|Salivary EGF (Epidermal Growth Factor) Protein Levels|Salivary EGF protein levels obtained from oral swabs were analyzed by commercially available EGF ELISA kit (R &D systems Inc). EGF protein levels were normalized to micrograms of protein in saliva, and expressed as picogram of EGF protein per microgram of total salivary protein.|Sampling occurred on average day of life 9 with a range from day of life 7 to 21|29 subjects were enrolled with 11 not completing the study and not analyzed due to lack of specimens|||picograms EGF/ microgram of protein||Full Range|Median
1453311|NCT00828412|Primary|Change From Baseline in Three Item Severity Score|The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.|Baseline to 6 weeks|All subjects with data were included in the analysis. No imputation was done for missing data.|||units on a scale||Standard Deviation|Mean
1453312|NCT00828347|Primary|Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level||Participants were followed for 24 weeks||||participants|||Number
1453313|NCT00828321|Secondary|AUC0-72 (Area Under the Concentration-time Curve From Time Zero to Time 72 Hours)of Ramiprilat.|Informational comparison of AUC0-72 values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453314|NCT00828321|Secondary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramiprilat.|Informational comparison of Cmax values for the metabolite Ramiprilat.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453315|NCT00828321|Primary|AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)of Ramipril.|Bioequivalence based on AUC0-t for Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453316|NCT00828321|Primary|AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)of Ramipril|Bioequivalence based on AUC0-t of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
1453317|NCT00828321|Primary|Cmax (Maximum Observed Concentration of Drug Substance in Plasma)of Ramipril|Bioequivalence based on Cmax of Ramipril.|Blood samples collected over a 72 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
1453318|NCT00828308|Primary|Prostate-Specific Antigen (PSA) Response|Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone|after 12 weeks of ixabepilone||||participants|||Number
1453319|NCT00828295|Secondary|Proportion of Patients With Complete Response 0-24 Hours|Complete Response defined as no vomiting, no retching, and no use of rescue medication|0-24 hours|Full Analysis Set|||percentage of patients||95% Confidence Interval|Number
1453320|NCT00828295|Primary|Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively||0-72 hours post-operatively|The Full Analysis Set (FAS) included all randomized patients, who received the study drug, had general anesthesia and surgery. Following the intent-to-treat principle, patients were assigned to the study treatment group according to the treatment to which they were randomized.|||percentage of patients||95% Confidence Interval|Number
1453322|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe|Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?|Day 23|Participants who received at least 1 injection with autoinjector and had a complete questionnaire. Missing data were not imputed.|||percentage of participants|||Number
1453323|NCT00828204|Other Pre-specified|Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector|"Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: Did you have any difficulty with your injection? The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented."|Day 1, Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex single-use autoinjector and submitted an assessment of injection procedure form. Missing data were not imputed. n=number of participants with assessment at the given timepoint.|||percentage of participants|||Number
1453324|NCT00828204|Other Pre-specified|Mean Score for Initial Subset on Autoinjector Instructions Grading Scale|"Participants in the Initial Subset were asked to answer the question How satisfied are you with the presentation of the autoinjector instructions? on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied)."|Day 8|Participants in the Initial Subset who received at least one injection with the Avonex single-use autoinjector and completed the grading scale.|||scores on a scale||Standard Deviation|Mean
1453325|NCT00828204|Other Pre-specified|Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective|Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.|Day 8, Day 15, Day 22|Participants in the Main Subset who received at least one injection with the Avonex Single-use Autoinjector and submitted an assessment form. n=the number of subjects completing the assessment form at the given timepoint. Missing data were not imputed.|||percentage of participants|||Number
1453326|NCT00828204|Other Pre-specified|Mean Score for Ease of Use Grading Scale|Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).|Day 1, Day 8, Day 15, Day 22|Participants who received at least one injection with the Avonex Single-use Autoinjector. Missing data were not imputed. n=number of participants who received an injection and had an assessment at the given timepoint.|||scores on a scale||Standard Deviation|Mean
1453327|NCT00828204|Other Pre-specified|Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector|The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.|Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)|Participants who received at least one injection with the Avonex single-use autoinjector. Missing data were not imputed.|||percentage of participants|||Number
1453328|NCT00828204|Other Pre-specified|Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector|"Number of participants in the Initial Subset who answered yes to the question Were you satisfied with this single-use injector? on the Subject Satisfaction Questionnaire."|Day 23|Participants in the Initial Subset who received at least 1 injection with autoinjector who had a complete Subject Satisfaction Questionnaire.|||participants|||Number
1453329|NCT00828204|Primary|Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector|A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.|Day 22|Participants in the Main Subset who received an injection of Avonex prefilled syringe as a manual IM injection, at least 1 injection of Avonex prefilled syringe using the autoinjector, and had a completed Observation Form were included in the analysis. Missing data were not imputed. All analyses are based on observed data.|||percentage of participants||95% Confidence Interval|Number
1453330|NCT00828191|Secondary|Delivery Rate||nearly 9 months after treatment start|All randomized patients|||percentage of randomized patients|||Number
1453331|NCT00828191|Secondary|Implantation Rate|Implantation rate was defined as the number of gestational sacs divided by the number of embryos transferred (%). This value was calculated for all the patients who had at least one embryo transferred.|4-5 weeks after treatment start|Patient who had at least one embryo transferred.|||percentage of embryos transferred||Standard Deviation|Mean
1453332|NCT00828191|Primary|Ongoing Pregnancy Rate||10 weeks after treatment start|All randomized patients were included in the analysis|||percentage of randomized patients|||Number
1453333|NCT00828178|Secondary|Effect on Markers of Inflammation: ICAM and VCAM by Omega-3 Versus Placebo.|The inflammatory markers (sICAM-1 and sVCAM-1) were assessed and compared before and after treatment. change from baseline were reported.|pre-treatment(baseline) and post-treatment (after 12 weeks)||||ng/ml||Standard Deviation|Mean
1453334|NCT00828178|Secondary|Effect of Omega-3 Versus Placebo on Disease Activity in SLE.|"The assessment measured change in disease activities using SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index Selena Modification - range 0-105) and PGA (Physician Global Assessment - range 0-3) comparing pre-treatment(baseline) vs post-treatment (after 12 weeks).~SELENA-SLEDAI - range 0-105, high score indicates high disease activity - weighted sum of sub-scale is used as total score.~PGA - range 0-3, high score indicates high disease activity."|pre-treatment(baseline) and post-treatment (after 12 weeks)||||Units on a scale||Standard Deviation|Mean
1453336|NCT00828139|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event.|Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.|Eligible patients who had received the protocol treatments were included in the adverse event summaries. Ant CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.|||Participants|||Number
1453337|NCT00828139|Secondary|Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)|"The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Disease assessment for response were performed every 6 weeks, up to 2 years.||||proportion of participants||90% Confidence Interval|Number
1453338|NCT00828139|Secondary|Overall Survival|Estimated to within at least 15% (95% confidence interval).|Weekly, up to 2 years.||||months||90% Confidence Interval|Median
1453339|NCT00828139|Primary|Progression-free Survival (PFS)|"From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause.~Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration."|Disease assessments were performed every 6 weeks, up to 2 years.||||Months||90% Confidence Interval|Median
1453340|NCT00828113|Primary|Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52|Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of < 10 parts per million as assessed at Week 52|7-day point prevalence|Participants randomized at 12 weeks who continued in the study to Week 52 and provided CO-verified smoking status.|||participants|||Number
1453341|NCT00828074|Secondary|Toxicity Profile|Number of Participants with Treatment-Related Grade 3 & 4 Toxicities for Sorafenib and Vinorelbine Combination|28 days following the last course of treatment||||participants|||Number
1453342|NCT00828074|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).|||Months||95% Confidence Interval|Median
1453343|NCT00828074|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.|After 2 cycles of treatment, up to 2 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion). Patients who complete 2 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 2 cycles of therapy on the Phase II portion of the study.|||percentage of participants|||Number
1453344|NCT00828074|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression, up to 5 years.|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).|||Months||95% Confidence Interval|Median
1453345|NCT00828074|Secondary|Progression-free Survival Rate at 4 Months|Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 months following the last course of treatment|All patients treated at the phase II vinorelbine dose (6 in the phase I portion, 35 in the phase II portion).|||percentage of participants|||Number
1453346|NCT00828074|Primary|Recommended Phase II Dose|The maximum tolerated dose (MTD) of Vinorelbine is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.|4 weeks from start of treatment, up to 2 years|All patients observed for 28 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.|||mg/m^2|||Number
1453347|NCT00828074|Primary|Number of Participants With at Least One Dose Limiting Toxicity in Phase I|Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy.|4 weeks from start of treatment, up to 2 years|All patients receiving treatment were evaluated for DLT.|||participants with DLTs|||Number
1453348|NCT00828061|Secondary|Change From Baseline at Hour 8 in the Percent of Total Cells That Are Eosinophils|Comparison of the Change in the Percent of Total Cells That Are Eosinophils Measured in Nasal Lavage After a Single Dose of 10 mg or 25 mg Prednisone Relative to Placebo|Baseline and Hour 8 post nasal allergen challenge|All Patients with Slide Quality ≤ 3 (Slide Quality measured on a 6 point scale with values > 3 indicating a level of debris that interferes with cell typing and counting).|||Percentage of cells that are eosinophils||95% Confidence Interval|Least Squares Mean
1453350|NCT00827983|Secondary|Implantation Rate|Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.|Four to five weeks after oocytes retrieval|All the patients who had at least one embryo transferred|||percentage of embryos transferred||Standard Deviation|Mean
1453351|NCT00827983|Secondary|Delivery Rate and Live Birth Rate||nearly 9 month after treatment start|all the randomised patients were included in the analysis|||percentage of randomised patients|||Number
1453352|NCT00827983|Primary|Ongoing Pregnancy Rate at the End of the Study||10 weeks after treatment start|ITT population was analysed (i.e. all the randomised patients)|||percentage of randomized patient|||Number
1453353|NCT00827944|Secondary|Other Post-operative Complications||M12 after surgery|As Treated population|||participants|||Number
1453354|NCT00827944|Secondary|Return to Work and to Normal Daily Activities||Effective date|The analysis were performed on an As Treated (AT) population, with a 5% significance level.|||days||Standard Error|Mean
1453355|NCT00827944|Secondary|Wound Complications and Hernia Recurrences||M12 after surgery|The analysis were performed on an As Treated (AT) population, with a 5% significance level.|||participants|||Number
1453356|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Surgical Pain Scales (SPS)|Surgical pain scales (=SPS) completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing. The score of evaluation will be reported in mm, specifying if pain occurs at rest, during normal activities, during exercise. The score is ranged from 0 (no pain) to 150 mm (the worst pain yu have never known).|M3, M12 after surgery|The analysis were performed on an As Treated population (AT), with a 5% significance level.|||units on a scale||Standard Deviation|Mean
1453357|NCT00827944|Primary|Pain Assessment During the First Three Months and at One Year After Surgery Using a Visual Analogue Scale (VAS)|Pain assessment during patient follow up after surgery using VAS score. VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|M3, M12 after surgery|The analysis were performed on an As Treated (AT)population, with a 5% significance level.|||units on a scale||Standard Deviation|Mean
1453358|NCT00827944|Secondary|Chronic Pain Defined as Pain Lasting More Than 3 Months Using VAS Score|Chronic pain defined as pain lasting more than 3 months using VAS score. A VAS going from 0 mm (no pain) to 150 mm (worst conceivable pain) is presented to the patient who draw a vertical line on the scale to indicate the average amount of pain at the time of consultation or at home.|3 months after surgery||||participants|||Number
1453359|NCT00827944|Secondary|Foreign Body Sensation|Foreign body sensation using a specific questionnaire at M1, M3, M12 months after surgery. Questionnaire will be completed by patient during consultation or will be sent to the patient with instructions to complete it and send it back by mailing.|M1, M3, M12 months after surgery|The analysis were performed on an As Treated population, with a 5% significance level.|||participants|||Number
1453360|NCT00827931|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||Participants|||Number
1453361|NCT00827931|Secondary|Hemoglobin Levels||End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||Gram/Deciliter (g/dL)||Standard Deviation|Mean
1453362|NCT00827931|Secondary|Percentage of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dL) hemoglobin or hematocrit value of 24 percent.|Up to Day 7 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||Percentage of participants||95% Confidence Interval|Number
1453363|NCT00827931|Secondary|Total Blood Loss as Assessed by the Gross’ Formula|Gross’ formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||mL||Standard Deviation|Mean
1453364|NCT00827931|Secondary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 2 post-surgery|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||mL||Standard Deviation|Mean
1453365|NCT00827931|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||mL||Standard Deviation|Mean
1453379|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
1453380|NCT00827827|Primary|Change in Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
1453366|NCT00827931|Primary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Post-operation, Day 1, Day 2 up to drain removal|Full Analysis Set (FAS) population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint.|||milliliter (mL)||Standard Deviation|Mean
1453367|NCT00827918|Secondary|Mean Change From Baseline in PANSS Negative Subscale at Week 4|PANSS Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms. The Negative scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS negative subscale measurements between baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1453368|NCT00827918|Secondary|Mean Change From Baseline in PANSS Positive Subscale at Week 4|PANSS Positive scale assesses hallucinations, delusions and related symptoms. The Positive scale has 7 items with an anchored Likert scale from 1 to 7 to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. A total score ranges from 7 to 49.|Baseline and Week 4|Randomized participants with any PANSS positive subscale measurements between baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1453369|NCT00827918|Secondary|Mean Change From Baseline in Clinical Global Impression – Severity of Illness Scale (CGI-S) at Week 4|CGI-S is a commonly used measure of symptom severity in treatment studies of participants with mental disorders. CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill.|Baseline and Week 4|Randomized participants with any CGI-S measurements between baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1453370|NCT00827918|Secondary|Percentage of Participants With Response at Week 4|Responders were defined as participants who demonstrated ≥ 20% improvement from baseline on the PANSS total score. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Week 4|Randomized participants with a PANSS measurement at Week 4.|||Percentage of participants|||Number
1453371|NCT00827918|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 4 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.|||Participants|||Number
1453372|NCT00827918|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 6 Weeks|All participants included in the All Patients as Treated (APaT) population received at least one dose of study treatment and were evaluated for safety.|||Participants|||Number
1453373|NCT00827918|Primary|Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) at Week 4|PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. PANSS measure is composed of 3 scales: Positive scale, Negative scale, and General Psychopathology scale. Positive scale assesses hallucinations, delusions and related symptoms; Negative scale assesses emotional withdrawal, lack of motivation, and similar symptoms; and General Psychopathology scale addresses other symptoms such as anxiety, somatic concern and disorientation. The PANSS has 30 items in its 3 scales and an anchored Likert scale from 1 to 7 is used to score each item. Values of 2 and above indicate the presence of progressively more severe symptoms. The Positive scale has 7 items with a score from 7 to 49, the Negative scale has 7 items with a score from 7 to 49, and the General Psychopathology scale has 16 items with a score from 16 to 112. A total score is the sum of the 3 scores for the 3 scales.|Baseline and Week 4|Randomized participants with any PANSS measurements between Baseline and Week 4.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1453374|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
1453375|NCT00827827|Primary|Change in Non-Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
1453376|NCT00827827|Primary|Change in Paretic Limb Step Length (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
1453377|NCT00827827|Primary|Change in Paretic Limb Step Length (Self-Selected)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||cm||Standard Error|Mean
1453378|NCT00827827|Primary|Change in Non-Paretic Limb Step Time (Fastest)|This and other measures come from Instrumented Walkway (Gait Rite)|Baseline, 3 Months|All participants for whom measurement was recorded at Baseline and 3 months|||seconds||Standard Error|Mean
1453382|NCT00827827|Primary|Change in Berg Balance Scale|This measure is a 14 item scale, with each item scored (0-4) and summed for a maximum score of 56 points. Range is 0-56 and higher values represent a better outcome.|Baseline, 3 months|All participants for whom a Berg Score was recorded at Baseline and 3 months|||Scores on a scale||Standard Error|Mean
1453383|NCT00827827|Primary|Change in Peak Aerobic Capacity (VO2 Peak)||Baseline, 3 Months|All participants for whom Peak Aerobic Capacity was recorded during Graded Treadmill Test at Baseline and 3 months|||mls/kg/min||Standard Error|Mean
1453384|NCT00827827|Primary|Change in 10 Meter Walking Speed (Fastest)||Baseline, 3 Months|All participants for whom 10 Meter walking Speed (Fastest-Safe) was recorded at Baseline and 3 months|||meters/ second||Standard Error|Mean
1453385|NCT00827827|Primary|Change in 10 Meter Walking Speed (Self-Selected)||Baseline, 3 months|All participants for whom 10 Meter walking Speed (Self-Selected) was recorded at Baseline and 3 months|||meters/ second||Standard Error|Mean
1453386|NCT00827827|Primary|Change in 6-minute Walk Distance||Baseline, 3 Months|All participants for whom 6-minute walk distance was recorded at Baseline and 3 months|||feet||Standard Error|Mean
1453387|NCT00827827|Primary|Change in Leg Muscle Endurance (Non-Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months|||repetitions||Standard Error|Mean
1453388|NCT00827827|Primary|Change in Leg Muscle Endurance (Paretic Side)|Tests how training impacts the total number of submaximal repetitions a participant can perform according to standardized cadence (at the same absolute level of resistance, pre and post).|Baseline, 3 Months|All participants for whom muscle endurance measurements were recorded at Baseline and 3 months|||repetitions||Standard Error|Mean
1453389|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Non-Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
1453390|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Extension, Paretic Side)||Baseline, 3 Months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
1453391|NCT00827827|Primary|Change in 1-RM Muscle Strength (Leg Press, Non-Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
1453392|NCT00827827|Primary|Change in 1-repetition Maximum (RM) Muscle Strength (Leg Press, Paretic Side)||Baseline, 3 months|All participants for whom strength measurements were recorded at Baseline and 3 months|||lbs||Standard Error|Mean
1453393|NCT00827632|Secondary|Pharmacokinetics of 15 Obese Weight and 15 Normal Weight Women on Combined Oral Contraceptives.||24 hours during week 3 of follow-up cycle|||||||
1453394|NCT00827632|Secondary|Possible Changes in Lipid or Carbohydrate Metabolism in Obese Versus Normal Weight Oral Contraceptive (OC) Users.||Screening and follow-up 1|||||||
1453395|NCT00827632|Primary|Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression.|"Perpendicular diameter, ethinyl estradiol, and progesterone values were used to create Hoogland Scores. Hoogland Scores were used to assess ovarian suppression during OC use. The Hoogland Score comprises 6 grades (Because of small numbers, grades 5 and 6 were combined):~no activity~potential activity~nonactive follicle-like structure~active follicle-like structure~luteinized unruptured follicle~ovulation~Each participant received a score from 1-6 to indicate the level of ovarian suppression; total number of participants were tallied for each Hoogland score."|Up to 8 biweekly visits from start of OCP therapy|Two hundred twenty-six women enrolled, 150 consistent OCP users were retained for the main analysis (96 normal weight and 54 obese).|||Participants|||Number
1453396|NCT00827606|Secondary|Percentage of Participants by Study Drug Compliance Category|Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.|Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)|Safety Analysis Set: all participants who received at least 1 dose of study drug; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1453397|NCT00827606|Primary|Percent Change From Baseline in FMD|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.|Months 6, 12, 18, 24, 30 and 36/ET|FMD Set; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453398|NCT00827606|Primary|Flow-Mediated Dilatation (FMD) During the Study|Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.|Baseline, Months 6, 12, 18, 24, 30 and 36/ET|FMD Set: all participants enrolled in the FMD study who had at least baseline FMD measurements. n=number of participants assessed for the specified parameter at a given visit.|||% FMD||Standard Deviation|Mean
1453399|NCT00827606|Secondary|Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator||Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1453400|NCT00827606|Primary|Percent Change From Baseline in Age: Females|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453401|NCT00827606|Primary|Age (Years) During the Study: Females|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||years||Standard Deviation|Mean
1453402|NCT00827606|Primary|Percent Change From Baseline in Age: Males|Investigator assessment of age during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1454252|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for On-ART Participants|Results reported are for HIV-1 RNA at study entry for on-ART participants.|At Entry|Analysis is based on all on-ART participants with HIV-1 RNA data at entry.|||participants|||Number
1453403|NCT00827606|Primary|Age (Years) During the Study: Males|Investigator assessment of age during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||years||Standard Deviation|Mean
1453404|NCT00827606|Primary|Percent Change From Baseline in BMI: Females|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453405|NCT00827606|Primary|BMI (kg/m^2) During the Study: Females|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg/m^2||Standard Deviation|Mean
1453406|NCT00827606|Primary|Percent Change From Baseline in BMI: Males|Investigator assessment of BMI changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453407|NCT00827606|Primary|Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males|Investigator assessment of BMI changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg/m^2||Standard Deviation|Mean
1453408|NCT00827606|Primary|Percent Change From Baseline in Weight: Females|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453409|NCT00827606|Primary|Weight (kg) During the Study: Females|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg||Standard Deviation|Mean
1453410|NCT00827606|Primary|Percent Change From Baseline in Weight: Males|Investigator assessment of weight changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453411|NCT00827606|Primary|Weight (Kilograms [kg]) During the Study: Males|Investigator assessment of weight changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||kg||Standard Deviation|Mean
1453412|NCT00827606|Primary|Percent Change From Baseline in Height: Females|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453413|NCT00827606|Primary|Height (cm) During the Study: Females|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only female participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||cm||Standard Deviation|Mean
1453414|NCT00827606|Primary|Percent Change From Baseline in Height: Males|Investigator assessment of height changes during the study.|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453415|NCT00827606|Primary|Height (Centimeters [cm]) During the Study: Males|Investigator assessment of height changes during the study. Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; only male participants were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.|||cm||Standard Deviation|Mean
1453416|NCT00827606|Primary|Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage|Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.|Baseline, Months 6, 12, 18, 24, 30, and 36/ET|FAS; n=number of participants assessed for the specific parameter at a given visit.|||participants|||Number
1453417|NCT00827606|Primary|Percent Change From Baseline in Apo B|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453418|NCT00827606|Primary|Apoliprotein B (Apo B; g/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||g/L||Standard Deviation|Mean
1453419|NCT00827606|Primary|Percent Change From Baseline in Apo A-1|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453420|NCT00827606|Primary|Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||g/L||Standard Deviation|Mean
1453421|NCT00827606|Primary|Percent Change From Baseline in VLDL|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453422|NCT00827606|Primary|Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
1453423|NCT00827606|Primary|Percent Change From Baseline in Trigylcerides|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453424|NCT00827606|Primary|Trigylcerides (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
1453425|NCT00827606|Primary|Percent Change From Baseline in Total Cholesterol|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453426|NCT00827606|Primary|Total Cholesterol (mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
1453427|NCT00827606|Primary|Percent Change From Baseline in HDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453428|NCT00827606|Primary|High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET|FAS; n=number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
1453429|NCT00827606|Primary|Percent Change From Baseline in LDL-C|Assessments were performed in the fasting state (minimum 10-hour fast).|Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)|FAS; n=number of participants assessed for the specified parameter at a given visit.|||percent change||Standard Deviation|Mean
1453430|NCT00827606|Primary|Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study|Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.|Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])|FAS; n (number) equals (=) number of participants assessed for the specified parameter at a given visit.|||mMol/L||Standard Deviation|Mean
1453431|NCT00827567|Primary|Time to Progression(TTP)|Progression is defined by RESIST criteria as any new lesion or the sum of target lesions increasing by 20% over baseline|Each patient assessed at 8 weeks from start of study drug|||||||
1453432|NCT00827541|Secondary|Number of Participants With Eradication of Microbiological Pathogens|Evaluation of eradication after treatment with tigecycline included following microbiological pathogens: E. coli ESBL; K. pneumoniae ESBL; Bacteroides species RClin; S. aureus (MRSA); Enterococcus species (VRE); Enterobacter species RCef3; Serratia species RCef3; Proteus species ESBL; P. aeruginosa RCarb; A. baumannii RCarb.|Week 12|Data was not analyzed since the number of samples obtained for culture was very low.|||participants|||Number
1453433|NCT00827541|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Week 12|Safety population included all evaluable participants who received at least one dose of study medication and had at least one evaluation visit.|||participants|||Number
1453434|NCT00827541|Secondary|Number of Participants With Susceptible Microbiological Pathogens|Evaluation of susceptibility to the tigecycline treatment included: Escherichia coli Extended Spectrum Beta Lactamases (E. coli ESBL); Klebsiella pneumoniae (K. pneumoniae) ESBL; Bacteroides species resistant to clindamycin (RClin); Staphylococcus aureus (S. aureus) methicillin resistant S. aureus (MRSA); vancomycin resistant Enterococcus (VRE) species; Resistant to third generation cephalosporins (RCef3) Enterobacter species; RCef3 Serratia species; Proteus species ESBL; carbapenem resistant (RCarb) Pseudomonas aeruginosa (P. aeruginosa); Acinetobacter baumannii (A. baumannii) RCarb.|Baseline and Week 12|Data was not summarized since the number of susceptibility tests to tigecycline during the study was extremely low.|||participants|||Number
1453435|NCT00827541|Secondary|Percentage of Participants With Clinical Response of Cure|Cure was defined as complete resolution of infection symptoms and clinical signs of the disease to the extent that no further antibiotic treatment was required, as assessed by the attending physician.|Days 2-5, 7-14 and 21-28 during treatment and Days 1-3 after end of treatment|Intent-To-Treat (ITT) population included all evaluable participants who had at least one dose of study medication and one evaluation visit. 'n' signifies those participants who were evaluated for this measure at specified time points for each group respectively.|||percentage of participants|||Number
1453436|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study|Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.|Baseline to 2 weeks|The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs.|||Participants|||Number
1453805|NCT00824005|Secondary|Reduction in Fixed Perfusion Defect(s)Via SPECT|Fixed total defect is the stress total defect minus the reversible component.|Measured at Baseline and Month 6|Only participants with both baseline and six month fixed defect data available are included.|||percentage of defect that is fixed||Standard Deviation|Mean
1453437|NCT00827502|Secondary|Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate|Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).|Baseline to 3 months|FAS|||cost (in Indian Rupees) per participant||Full Range|Median
1453438|NCT00827502|Primary|Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study|Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.|Baseline to 2 weeks|The full analysis set (FAS) included all subjects who received at least one dose of study medication.|||participants|||Number
1453439|NCT00827372|Secondary|Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions)|"The quality of life questionnaire (FACT-B+4 lymphedema questions) was given at various timepoints during the study. The values for the subscales are given for baseline, Cycle 1:Day 1, Cycle 2:Day 1, and Cycle 6:Day 1.~Physical Well-Being (PWB; sum of 7 items, point range 0-28) Social /Family Well-Being (SWB, sum of 7-items, point range 0-28) Emotional Well-Being (EWB; sum of 6-items, point range 0-24) Functional Well-Being (FWB; sum of 7-items, point range 0-28) Additional Concerns (BCS; sum of 9-items, point range 0-36) Arm subscale (AS; sum of 5-items, point range 0-20) -- This was not collected in Cycle 1 or 2.~Fact-B+4 score=Sum of PWB, SWB, EWB, FWB, BCS, AS, point range 0-164 Trial Outcome Index=Sum of PWB, FWB, BCS, point range 0-92 Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108 Fact-B score=sum of PWB, SWB, EWB, FWB, BCS, point range 0-144 Note: The higher the score, the better the outcome"|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline/Cycle 1, Day 1, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.|||Units on a scale||Standard Deviation|Mean
1453440|NCT00827372|Secondary|Number of Patients With Trt Related Grade 2+ AEs|This is the number of patients who had greater than or equal to Grade 2 Adverse Events related to treatment. This also includes the number of patients who had treatment related Grade 2 or greater Adverse Events that lasted more than 2 weeks (14 days) and excluded events of hypertension (labeled as 'special').|End of Treatment|All treated patients|||participants|||Number
1453441|NCT00827372|Secondary|Change in Impedance or ECF Volume in the Arm|"Arm impedance was reported at two baseline readings and for Cycle 2, Day 1.~To assess the degree of improvement in arm edema as measured by changes in arm impedance (ECF volume using an automated device lymphometer). Data reported is the ratio of the impedance in the affected versus unaffected arm"|Baseline, and Cycle 2, Day 1|All patients with non-missing results. This includes 8 patients at the first baseline, 10 patients at the second baseline, and 7 patients at Cycle 2, Day 1.|||ratio||Standard Deviation|Median
1453442|NCT00827372|Secondary|Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm|"Interstitial fluid pressure was reported at 24 hours. This is the difference in the last-first reading, affected arm.~To assess the degree of improvement in arm edema as measured by changes in interstitial fluid pressure (ECF volume using an automated device lymphometer)"|First 24 hours after drug was administered|All patients with non-missing results at both baseline and at 24 hours.|||mm Hg||Standard Deviation|Mean
1453443|NCT00827372|Primary|Change in Volume Ipsilateral Lymphedema in Arm|The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days).|Baseline through Cycle 6, Day 1|All patients with non-missing results. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment.|||mL||Standard Deviation|Mean
1453444|NCT00827255|Secondary|Schirmer's Test at Month 12|Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.|Month 12|ITT population, which consisted of all patients included in the study with Schirmer's testing data available at baseline. Data not reported due to limited number of patients with Schirmer's test data recorded.|||Millimeters per five minutes (mm/5min)||Standard Deviation|Mean
1453445|NCT00827255|Primary|Percentage of Patients With Complete Clearing of Corneal Staining at Month 12|Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.|Month 12|ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline.|||Percentage of Patients|||Number
1453446|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Postvoid Residual (PVR) Volume|The amount of urine remaining in the bladder after void completion.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL||Standard Deviation|Mean
1453447|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Voided Volume (Vcomp) by Uroflowmetry|Vcomp was defined as the volume of urine voided (measured in mL using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL||Standard Deviation|Mean
1453469|NCT00827112|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||Percentage of participants||95% Confidence Interval|Number
1453448|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Mean Flow Rate (Qmean) by Uroflowmetry|Qmean was defined as the mean urine flow rate (measured in mL/sec using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 mL and the Vcomp was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL/sec||Standard Deviation|Mean
1453449|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Peak Flow Rate (Qmax) by Uroflowmetry|Qmax was defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at endpoint (considered the last non-missing post-baseline value).|||mL/sec||Standard Deviation|Mean
1453450|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Index of Erectile Function (IIEF)- Erectile Function (EF) Domain Scores|Self-reported EF. Scores range from 0 (low or no EF) to 5 (high EF) on 6 questions (1-5, 15 of the IIEF). EF Domain scores range from 0 to 30. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. Measures were taken only for those subjects who reported they were sexually active and reported erectile dysfunction. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
1453451|NCT00827242|Secondary|Change From Baseline to 4 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 Weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.|||Units on a Scale||Standard Error|Least Squares Mean
1453452|NCT00827242|Secondary|Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 1 week|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 1.|||Units on a Scale||Standard Error|Least Squares Mean
1453453|NCT00827242|Secondary|Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|12 weeks|All values are based on the number of subjects in the analysis population with non-missing data.|||Participants|||Number
1453454|NCT00827242|Secondary|Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data.|||Participants|||Number
1453455|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
1453456|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question|Measures nocturia (the need to get up at night to urinate). Scores range from 0 (few episodes of nocturia) to 5 (frequent episodes of nocturia). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
1453457|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
1454684|NCT00815685|Primary|Change in Serum Albumin|Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers.|6 weeks per patient||||g/dL||Full Range|Median
1453458|NCT00827242|Secondary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
1453459|NCT00827242|Secondary|Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 12. For the 12 week analysis, the LOCF imputation technique was used.|||Units on a Scale||Standard Error|Least Squares Mean
1453460|NCT00827242|Secondary|Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index|The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 4 weeks|The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4.|||Units on a Scale||Standard Error|Least Squares Mean
1453461|NCT00827242|Primary|Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS)|The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction.|Baseline, 12 weeks|The analysis population was defined as all subjects who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline visit. The Last Observation Carried Forward (LOCF) imputation technique was employed.|||Units on a Scale||Standard Error|Least Squares Mean
1453462|NCT00827112|Secondary|Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay|Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.|Baseline to Week 96 or Time of treatment Failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Participants|||Number
1453463|NCT00827112|Secondary|Number of Participants With Phenotypic Resistance|Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Participants|||Number
1453464|NCT00827112|Secondary|Number of Participants With Genotypic Resistance|Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.|Week 96 or Time of treatment failure|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Participants|||Number
1453465|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||cells/mcL||Standard Deviation|Mean
1453466|NCT00827112|Secondary|Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||cells/microliter (cells/mcL)||Standard Deviation|Mean
1453467|NCT00827112|Secondary|Time-Averaged Difference (TAD) in log10 Viral Load|TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).|Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here N (Number of participants analyzed) signified participants evaluable for the measure.|||log10 copies/mL||Standard Error|Mean
1453468|NCT00827112|Secondary|Time to Loss of Virological Response (TLOVR)|TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.|Baseline through Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement.|||Days||Standard Error|Mean
1453470|NCT00827112|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA||Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||Percentage of participants||95% Confidence Interval|Number
1453471|NCT00827112|Secondary|Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96||Baseline, Week 16, Week 24, Week 48, Week 96|FAS population included those participants who had taken at least one dose of the study drug, had a baseline and at least one post baseline measurement. Here “n” signified participants who received the study drug and evaluated at the time point.|||log10 copies/ml||Standard Deviation|Mean
1453472|NCT00827112|Secondary|Average Observed Plasma Concentration (Cavg) of Maraviroc|Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).|Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.|||ng/mL||Standard Deviation|Mean
1453473|NCT00827112|Secondary|Minimum Observed Plasma Concentration (Cmin) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|PK parameter analysis population included first 15 participants treated with maraviroc.|||ng/mL||Full Range|Median
1453474|NCT00827112|Secondary|Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)|Pharmacokinetic (PK) parameter analysis population included first 15 participants treated with maraviroc.|||nanogram (ng)/mL||Full Range|Median
1453475|NCT00827112|Secondary|Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14|Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.|Baseline , Days 4, 7, 10 and 14|First 15 participants who were enrolled at U.S sites and had taken the study drug .|||copies/mL||Standard Deviation|Mean
1453476|NCT00827112|Secondary|HIV-1 RNA Levels at Baseline||Baseline|FAS population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.|||copies/mL||Standard Deviation|Mean
1453477|NCT00827112|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)||Week 48|Full Analysis Set (FAS) population included those participants who had taken at least one dose of the study drug, had baseline and at least one post baseline measurement.|||Percentage of participants||95% Confidence Interval|Number
1453478|NCT00827099|Secondary|Number of Patients Who Survive Following Treatment on This Protocol|Patients will be followed until death|Through Death|This study was terminated early. No participants were analyzed.|||participants|||Number
1453479|NCT00827099|Secondary|Number of Patients Who Experience Disease Relapse Post-transplant|Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time.|Day 100, 6 months, 1 year, 18 months, 24 months|This study was terminated early. No participants were analyzed.|||participants|||Number
1453480|NCT00827099|Secondary|Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.|Patients will be evaluated regularly for the development of graft versus host disease both acute & chronic.|Day 30|This study was terminated early. No participants were analyzed.|||participants|||Number
1453481|NCT00827099|Secondary|Percentage of Donor and Host Chimerism of Each Cord Blood Unit|Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.|day 30, day 60, day 90|This study was terminated early. No participants were analyzed.|||percentage of chimerism|||Number
1453482|NCT00827099|Secondary|Number of Patients That Engrafted Blood Counts by 30 Days After Transplant|Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant|Day 30||||participants|||Number
1453483|NCT00827099|Primary|Number of Participants With 100 Day Transplant-related Mortality (TRM)|100 Day TRM is death within 100 days from transplant related complications|100 days||||participants|||Number
1453484|NCT00827073|Primary|Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs||(1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)||||bacterial spceies||Standard Deviation|Mean
1453485|NCT00827073|Primary|Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs|Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.|(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)||||Ln(bacterial colony count)||Standard Deviation|Mean
1453486|NCT00826943|Primary|Likert Score Rating Global Sedation|"Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.~This was mean data for all interventions."|duration of study (36 days)|per protocol|||Likert score||Standard Deviation|Mean
1453487|NCT00826943|Primary|Modified Epworth Sleepiness Scale|"Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.~This was mean data for all interventions."|36 days of the study|per protocol|||units on a scale||Standard Deviation|Mean
1453488|NCT00826943|Secondary|Total Four Symptom Scores (Allergy Symptoms)|"Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.~This was mean data for all interventions."|same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)||||TFSS scores||Standard Deviation|Mean
1453489|NCT00826800|Primary|To Determine the Pathologic Complete Response (Path CR) Rate in Patients With Locally Advanced (Stage II or III) Colon Cancer to FOLFOX-bevacizumab Administered as Neoadjuvant.||3 years||||participants|||Number
1453490|NCT00826748|Primary|Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14|The primary study endpoint is a change in the gene expression in the airway epithelium or alveolar macrophages of healthy smokers following treatment with beclomethasone. Airway epithelium and alveolar macrophages are processed to yield high quality RNA. Complementary DNA (cDNA) is transcribed from the RNA in vitro and the product is hybridized onto gene microarray chips. The chip is then scanned and the image analyzed using the Affymetrix Microarray suite version 5 (MAS5) algorithm. Using GeneSpring software the data is normalized and differential expression is determined by fold change (up or down regulation) of the individual genes by comparing the geometric mean expression value from the airway epithelium and alveolar macrophages obtained from Day 7 and Day 14 following initiation of therapy to baseline values.|Analysis will be done on samples collected on Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on the day prior to initiation of treatment.|Subjects underwent bronchoscopy procedure at 7 and 14 days after baseline to collect samples including small airway epithelium and alveolar macrophages.|||Participants|||Count of Participants
1453491|NCT00826618|Secondary|The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24.||2 years|||||||
1453492|NCT00826618|Secondary|The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test.||1 year|||||||
1453493|NCT00826618|Secondary|The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months.||1 year|||||||
1453494|NCT00826618|Secondary|The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test.||1 year|||||||
1453495|NCT00826618|Primary|Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months.|Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015).|1 year||||Change in ETDRS Letters||Standard Deviation|Mean
1453496|NCT00826540|Secondary|Feasibility of Study Treatment|Will be evaluated based on the number of patients who are able to > tolerate the regimen, how long they tolerate it and whether they elect to stop treatment.|Up to 2 years|||||||
1453497|NCT00826540|Secondary|Overall Survival|The distribution of overall survival will be estimated using Kaplan-Meier methodology.|Time from registration to death, assessed up to 2 years|||||||
1453498|NCT00826540|Secondary|Response Rate|Simple frequency analysis will be conducted to see if response rate is related to prior treatment and the selected tumor biomarkers. Descriptive statistics will be used to investigate how prior treatment affects various other measures as well.|Up to 2 years|||||||
1453499|NCT00826540|Primary|Progression-free Survival Rate|"The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.~Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions."|At 3 months||||percentage of participants||95% Confidence Interval|Number
1453500|NCT00826449|Secondary|Phase II: Progression-Free Survival (PFS) Rate|A modified Thall, Simon, and Estey (1995) design used in the phase II study to monitor the proportion of patients with NSCLC who are alive and progression free (PFS) at twelve weeks after commencing treatment with dasatinib and erlotinib.|12 Weeks|Of the 35 participants in the Phase II portion of the study, one participant received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.|||Percentage of Participants|||Number
1453501|NCT00826449|Secondary|Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Patients who have a partial or complete response or stable disease are defined as progression free. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.|12 Weeks|One participant only received one day of therapy therefore was not evaluable for efficacy analyses; a second participant discontinued study treatment.|||participants|||Number
1453502|NCT00826449|Primary|Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride|MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose-limiting toxicity (DLT) defined using NCI Common Terminology Common Terminology Criteria for Adverse Events (CTCAE) version 3 as: grade 3 or higher non-hematologic toxicity (excluding initial nausea and vomiting), grade 4 neutropenia, febrile neutropenia, or grade 4 thrombocytopenia. Grade 3-4 nausea and vomiting that cannot be controlled within 2 weeks with anti-emetics considered a DLT.|Baseline and at Day 21||||mg/day|||Number
1453503|NCT00826280|Secondary|Change From Baseline in Diastolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||mmHg||Full Range|Median
1453504|NCT00826280|Secondary|Change From Baseline in Systolic Blood Pressure|"Baseline is the last non-missing measurement on or before first dose of regadenoson.~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||mmHg||Full Range|Median
1453505|NCT00826280|Secondary|Change From Baseline in Heart Rate|"Baseline is the last non-missing measurement on or before first dose of regadenoson~Change is calculated as the time point minus baseline."|Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)|The number of participants analyzed per arm represents Safety Analysis Set (SAF) all randomized patients who received at least one dose of regadenoson. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||Beats per minute||Full Range|Median
1453506|NCT00826280|Secondary|Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).~Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).~The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||Summed Difference Score||Standard Deviation|Mean
1453507|NCT00826280|Secondary|Change in Number of Reversible Defects Assessed by Computerized Quantitation|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.~Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|The number of participants analyzed per arm represents Full Analysis Set (FAS), all randomized subjects with interpretable MPI scans. The number of participants included in the calculation for each visit is noted in the category titles, as “N”.|||Reversible Defects||Standard Deviation|Mean
1453508|NCT00826280|Secondary|Change in Summed Difference Score (SDS) Across All 17 Segments|"The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions).~Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3).~The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable MPI scans.~The number of participants per arm is consistent for all categories of the data table."|||Sum Difference Score||Standard Deviation|Mean
1453509|NCT00826280|Primary|Change in Number of Reversible Defects|"Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2.~Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3)."|Day 3 and Day 5|"The number of participants analyzed represents Full Analysis Set (FAS), which included all randomized subjects with interpretable Myocardial Perfusion Imaging (MPI) scans.~The number of participants per arm is consistent for all categories of the data table."|||Reversible Defects||Standard Deviation|Mean
1453510|NCT00826267|Secondary|Changes in Biomarker in Tumour Biopsies|Changes in the biomarkers (Phospho-MAP-Kinase (MAPK), Total MAPK expression, EGFR, HER2, Phospho-EGFR and -HER2, Proliferation marker (Ki67 and p27), Apoptotic index (cleaved caspase 3), Phosphate and tensin homolog (PTEN), HER2 homodimerisation by HERmark assay and Phospho AKT) from biopsy tissue.|Screening, day 22, day 43|TS. The small number of available biomarker samples in this study did not allow for a meaningful statistical analysis.||||||
1453511|NCT00826267|Secondary|Plasma Concentration of Afatinib|Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1453512|NCT00826267|Secondary|Change From Baseline in the Diameter of the Primary Target Lesion.|Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.|3 weeks or 6 weeks|TS|||millimeters||Standard Error|Least Squares Mean
1453513|NCT00826267|Secondary|Number of Participants Who Achieved Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|Tumour assessments were performed at screening, day 22 and day 43.|TS|||Participants|||Number
1453514|NCT00826267|Primary|Objective Response (OR)|Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, day 22 and day 43.|Treated set (TS). TS consisted of all patients who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
1453515|NCT00826228|Secondary|P1NP|amino-terminal propeptide of type I collagen (P1NP)|Baseline to 6 months|Only 8 of the total 12 participants enrolled had serum available for testing|||% change from baseline||Standard Deviation|Mean
1453516|NCT00826228|Primary|BMD at Left Total Hip|Bone mineral density (gm/cm2) of the total hip region of interest on the left|Baseline to 6 months||||% change in BMD (gm/cm2) from baseline||Standard Deviation|Mean
1453517|NCT00826202|Secondary|Pittsburgh Sleep Quality Index Score|The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and five questions rated by the bed partner or roommate. The latter five questions are used for clinical information only, are not tabulated in the scoring of the PSQI. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. These I9 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores|16 weeks|Completers at NYSPI and NKI sites|||final score||Standard Deviation|Mean
1454253|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Weeks 12 and 24 for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at week 12 and week 24 for off-ART participants.|At weeks 12 and 24|Analysis is based on all off-ART participants with HIV-1 RNA data at week 12 and week 24.|||log10 copies/mL||Inter-Quartile Range|Median
1453518|NCT00826202|Primary|Scale of Prodromal Symptoms (SOPS) Negative Scale|The SOPS Negative symptom scale consists of six Negative Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 36.|16 weeks||||SOPS negative final score||Standard Deviation|Mean
1453519|NCT00826202|Secondary|IL6 Levels|Final IL6 levels (pg/ml) in available subjects|16 weeks||||final IL6 level (pg/ml))||Standard Deviation|Mean
1453520|NCT00826202|Secondary|Scale of Prodromal Symptoms (SOPS) Total|The SOPS Total consists of five Positive Symptom items, six Negative Symptom items, four Disorganization Symptom items, and four General Symptom items. Each item has a severity scale rating from 0 (Never, Absent) to 6 (Severe/Extreme—and Psychotic, for the positive items). The severity of the prodromal state is judged according to the sum of the ratings from each of the SOPS items and ranges from 0 to 114.|16 weeks||||units on a scale||Standard Deviation|Mean
1453521|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.|||minutes||95% Confidence Interval|Geometric Mean
1453522|NCT00826176|Secondary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.|||minutes||95% Confidence Interval|Geometric Mean
1453523|NCT00826176|Primary|Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.~Analysis of recovery in Chinese subjects was the primary objective; Caucasian subjects and between-group analyses were secondary."|Start of administration of sugammadex to recovery from neuromuscular blockade|The Full Analysis Set (FAS) consisted of all subjects who received sugammadex and had at least one efficacy measurement. One treated Chinese subject did not have any efficacy data and was thus excluded from the FAS. Hence, 114 Chinese Asian and 36 European Caucasian subjects were included in the FAS.|||minutes||95% Confidence Interval|Geometric Mean
1453524|NCT00826111|Secondary|Change in Insomnia Severity Index Score From Baseline to Week 10|The Insomnia Severity Index is a 7 item scale that assesses difficulty sleeping and effect on quality of life with item scores from 0-4. The total score range is 0 to 28 with higher scores indicating higher levels of impairment and distress.|baseline and 10 weeks||||scores on a scale||Standard Deviation|Mean
1453525|NCT00826111|Secondary|Change in Hamilton Anxiety Rating Scale Score From Baseline to Week 10|The Hamilton Anxiety Rating Scale is a 14 item ordinal scale that assesses symptoms of anxiety with ratings from 0-4. The score range is 0 to 56, with a higher score indicating higher levels of anxiety. A score of 15 was designated as the cut-off for enrollment in the study.|baseline and 10 weeks|Participants who completed 10 weeks and one participant who completed 6 weeks (using last observation carried forward) were included in this analysis.|||scores on a scale||Standard Deviation|Mean
1453526|NCT00826111|Secondary|Change in Hamilton Depression Rating Scale Score From Baseline to Week 10|The Hamilton Depression Rating Scale is a 21 item scale that assesses symptoms of depression with items rated on a scale of 0-4 or 0-2. The total score range is 0 to 65. A score of 7 or lower is generally considered to be an absence of depressive symptoms. A score of 18 was considered to be the cut-off for enrollment in this study, as this indicates clinically significant depression. A higher score represents greater severity of depressive symptoms.|baseline and 10 weeks||||scores on a scale||Standard Deviation|Mean
1453527|NCT00826111|Secondary|Change in Thalamic GABA From Baseline to Week 1|GABA levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (GABA to creatine)||Standard Deviation|Mean
1453528|NCT00826111|Secondary|Change in Anterior Cingulate Cortex GABA From Baseline to Week 1|GABA levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the GABA values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (GABA to creatine)||Standard Deviation|Mean
1453529|NCT00826111|Secondary|Change in Thalamic Glutamate From Baseline to Week 1|Glutamate levels were measured in the left thalamus using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (glutamate to creatine)||Standard Deviation|Mean
1453530|NCT00826111|Secondary|Change in Anterior Cingulate Cortex Glutamate From Baseline to Week 1|Glutamate levels were measured in the anterior cingulate cortex using single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamate values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week||||ratio (glutamate to creatine)||Standard Deviation|Mean
1454254|NCT00819390|Secondary|HIV-1 RNA Copies/mL at Study Entry for Off-ART Participants|Results reported are for HIV-1 RNA (copies/mL) at study entry for off-ART participants.|At Entry|Analysis is based on all off-ART participants with HIV-1 RNA data at entry.|||log10 copies/mL||Inter-Quartile Range|Median
1453531|NCT00826111|Primary|Change in Thalamic Glutamine From Baseline to Week 1|Glutamine levels were measured by single voxel magnetic resonance spectroscopy in the left thalamus. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants were included in the analysis if they had usable spectroscopy data from baseline and week 1 and were not considered to have any confounding issues such as an abnormal structural MRI.|||ratio (glutamine to creatine)||Standard Deviation|Mean
1453532|NCT00826111|Primary|Change in Anterior Cingulate Cortex Glutamine From Baseline to Week 1.|Glutamine levels were measured by single voxel magnetic resonance spectroscopy. In order to normalize the data, the glutamine values were expressed as a ratio to levels of creatine, since creatine levels are not expected to vary significantly.|baseline and 1 week|Participants who had usable MRS data from both the baseline and week 1 scans were included in the analysis. Participants whose data was considered unreliable were excluded.|||ratio (glutamine to creatine)||Standard Deviation|Mean
1453533|NCT00826007|Primary|Hypoglycemia Incidence|Blood glucose values <70 mg/dl|perioperative period||||participants|||Number
1453534|NCT00825994|Secondary|Change in Hot Flash Daily Interference Scale (HFRDIS)|Vasomotor symptoms (hot flashes) were tracked by using a self-report Hot Flash Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item self-report questionnaire in which subjects rate the degree to which hot flashes interfere with daily activities and quality-of-life during the prior week. Each item is rated on a scale from 0 (does not interfere) to 10 (completely interferes) for a total score range of 0-100 (higher score indicates greater symptom burden/interference).|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study. Of these 20, 15 women had hot flashes at baseline and could be included in the hot flash analysis.|||units on a scale||Standard Deviation|Mean
1453535|NCT00825994|Primary|Change in MADRS Score|"The instrument used to measure mood at each visit was the Montgomery-Åsberg Depression Rating Scale (MADRS).~The MADRS is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden)."|8 weeks|Of 31 women who consented to participate per protocol 24 were eligible. Of these 24 eligible participants, three women withdrew and one was a placebo responder. 20 women started omega-3 fatty acid treatment and 19 completed the study.|||units on a scale||Standard Deviation|Mean
1453536|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)|This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume, and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the smooth interpolated skin surface, and was always a negative number. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters cubed||Standard Deviation|Mean
1453537|NCT00825916|Secondary|Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)|This secondary outcome included scar measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface and was always a negative number. A more negative number was worse because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
1453538|NCT00825916|Secondary|Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters|At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 millimeters (mm), with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in longitudinal (chronological) order. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 for each of the two raters separately. Data from the two raters was not combined.|12 months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Millimeters||Standard Deviation|Mean
1453539|NCT00825916|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo, 3 mg AZX100, and 10 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 3 mg and 10 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 Months|In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data.|||Units on a scale||Standard Deviation|Mean
1453540|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left primary visual cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
1453541|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of placebo was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right lingual gyrus and right superior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
1453542|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right inferior lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
1453543|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right lateral occipital cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
1453544|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.|Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right occipital fusiform gyrus.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
1453545|NCT00825825|Secondary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.|Activation was measured using BOLD fMRI in response to affective faces and a fixation stimulus presented in an overt or unmasked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right insular cortex.|2 weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
1453546|NCT00825825|Primary|Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.|Activation was measured using BOLD fMRI in response to happy and fearful faces presented in a rapid covert or masked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left middle temporal gyrus.|two weeks|Participants were only included in the analysis if they had complete data for all 3 fMRI scans and motion was within acceptable limits. Participants also had to have detectable plasma levels of R-citalopram and S-citalopram in order to be included in the final analysis.|||voxels|||Number
1453547|NCT00825812|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|The Full Analysis Set population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.|||minutes||95% Confidence Interval|Geometric Mean
1453574|NCT00825370|Primary|Percentage of Patients With Successful Treatment|Successful treatment was defined as either declining additional pain medication when asked at 15 minutes or accepting additional pain medication at 15 minutes but then declining additional pain medication at 60 minutes|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients included in analysis is due to missing data (6 from Protocolized and 4 from Discretionary Care) and participants enrolled more than once (2 from Protocolized).|||Percentage of Participants|||Number
1453575|NCT00825344|Secondary|Chronic Post-surgical Pain|Patients with persistent post-surgical pain|Up to 12 months||||participants|||Number
1453548|NCT00825812|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.|"Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.~The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary."|start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade|"The Full Analysis Set (FAS) population included all subjects who received randomized treatment and had at least one efficacy measurement. In the event of missing data, imputed data were used for analysis.~291 subjects received IMP, of whom two had no efficacy measurements at all. Hence the FAS consisted of 289 subjects."|||minutes||95% Confidence Interval|Geometric Mean
1453549|NCT00825786|Secondary|Total Opioid Consumption|In morphine equivalent dose|postoperative day 1 to day 3||||mg||Inter-Quartile Range|Median
1453550|NCT00825786|Secondary|Duration of Analgesia|Time from the complete onset of sensory block until first request for an analgesic|from surgery date to postoperative day 1||||hours||Inter-Quartile Range|Median
1453551|NCT00825786|Secondary|Maximum Verbal Response Score (VRS) With Movement|The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10 = worst|through post operative day 3||||mm||Inter-Quartile Range|Median
1453552|NCT00825786|Secondary|Maximum Verbal Response Score (VRS) With Rest|The severity of postoperative pain was assessed by an observer blinded to treatment using a 0- to 10-point verbal response score (VRS): 0 = no pain and 10= worst pain|through post operative day 3||||mm||Inter-Quartile Range|Median
1453553|NCT00825786|Secondary|Time to Onset of First Sensory Block||during surgery||||minutes||Inter-Quartile Range|Median
1453554|NCT00825786|Secondary|Time to Complete Motor Block||during surgery from induction time to end case time||||minutes||Inter-Quartile Range|Median
1453555|NCT00825786|Primary|Duration of Analgesia.|The primary outcomes will be the onset time, onset of surgical block, and duration of analgesia.|During surgery: postoperative day 0||||minute||Inter-Quartile Range|Median
1453556|NCT00825734|Secondary|Number of Patients With Adverse Events as a Measure of of Safety and Tolerability|Assessments are made through analysis of reported incidence of treatment-emergent AEs and SAEs.|every 9 weeks until treatment discontinuation or unacceptable toxicity|Patients treated at the Phase II dose|||participants|||Number
1453557|NCT00825734|Secondary|Overall Survival (OS)|Measured from Day 1 of study drug administration to date of death due to any cause.|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose|||months||95% Confidence Interval|Median
1453558|NCT00825734|Secondary|Objective Response Rate|Objective Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST).|every 9 weeks until discontinuation of treatment|Includes patients treated at the Phase II dose who were evaluable for response|||patients|||Number
1453559|NCT00825734|Secondary|6-month Progression-Free Survival|Measured from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks, up to 6 months|Includes patients treated at the Phase II dose|||percentage of participants|||Number
1453560|NCT00825734|Primary|Progression-Free Survival (PFS)|Measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) - progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 9 weeks until treatment discontinuation or death on study|Includes patients treated at the Phase II dose|||months||95% Confidence Interval|Median
1453561|NCT00825682|Secondary|The General Sleep Disturbance Scale (GSDS), Compiled by Lee (1992) and Translated Into Hebrew by Dr. Dorit Pud (2007)|"examines several aspects of sleep disorders and includes 21 items that describe feelings and behaviors associated with sleep during the last week. It uses a 0 (never) to 7 (every day) Likert scale on questions like feeling nervous during the day; falling asleep while unplanned and using sleeping pills.~A total sleep disturbance score was calculated as the average of all 21 items (ranging between 0 and 7), higher scores indicating a worse outcome."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 34 women in the experimental group and 20 in the control group.|||Scores on a scale||Standard Deviation|Mean
1453562|NCT00825682|Secondary|The Multidimensional Quality of Life Scale Cancer MQOLS-CA Was Written by Padilla (1992) and Translated Into Hebrew by Dorit Pud (2007).|"The questionnaire includes 33 items describing different forms in which the disease may affect patient's quality of life. For each item, subjects are asked to mark the number that best describes their feelings right now, in a Likert scale ranging between 0 and 10. Items include happiness feelings, anxiety levels, how affected are the social ties because of the disease, etc.~A total quality of life score was calculated as the average of all 33 items (ranging between 0 and 10), higher scores indicating a better quality of life."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final ananlysis included 34 women in the experimental group, and 20 women in the control group.|||Scores on a scale||Standard Deviation|Mean
1453576|NCT00825344|Secondary|Analgesic Usage|Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery|24 hours||||tablets||Standard Deviation|Mean
1453577|NCT00825344|Primary|Numerical Rating Scale Pain Score|0-10 pain score through 24-hours post-surgery. 0 is no pain and 10 is the worse pain imaginable. The primary outcome reported measure is the average of 4 scores, each comprised of 6-hour time intervals during the 24hour period.|24 hours||||units on a scale||Standard Deviation|Mean
1453578|NCT00825318|Primary|Mean Arterial Blood Pressure||Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)||||mm Hg||Full Range|Mean
1453563|NCT00825682|Primary|The Lee Fatigue Scale|"The Lee Fatigue Scale consists of 18 items related to fatigue and energy: 13 items in the fatigue subscale and 5 items in the energy subscale. The mean of the 13 items in the fatigue subscale (range from 0-10) and the mean of the 5 items in the energy subscale (range from 0-10) are calculated. Higher scores indicate higher levels of perceived fatigue and energy . Items in the energy subscale were recoded, and a Lee fatigue total score was calculated as the average of all 18 items (ranging between 0 and 10), higher scores indicating higher levels of fatigue.~The Cronbach's Alpha reliability coefficient of the English version of the questionnaire is 0.77 . The questionnaire's validity and reliability have been established in cancer patients."|Beginning of study (initiation of radiation therapy and reflexology), 5 weeks after start (end of radiation therapy), 10 weeks after start|The final analysis included 33 women in the experimental group and 20 in the control group.|||units on a scale||Standard Deviation|Mean
1453564|NCT00825630|Primary|Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.|Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy.|17 days|Analysis was done on an ITT basis and approximately 25 subjects per group were anticipated in order to obtain a general evaluation of which PPI is will cause the least amount of false negatives.The actual amount of subjects in each group will depend upon the availability of the different PPIs through the course of the study.|||participants|||Number
1453565|NCT00825565|Primary|Physician Assessment of Individual Signs|"In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated.~This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe"|baseline and at 12 weeks|Subjects who used cream on entire body for the entire month was used in the analysis.|||Participants|||Count of Participants
1453566|NCT00825565|Primary|Physician Global Assessment of Severity (PGAS)|"The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a global impression.~This scale produced a score with the following correlations:~0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)"|baseline and then every 4 weeks for a total of 12 weeks|One subject discontinued after week 3. One subject discontinued at Month 2. Only data presented for subjects who used cream on entire body for the entire month was used in the analysis.|||Participants|||Count of Participants
1453567|NCT00825565|Primary|Target Wound Size Reduction or Closure|"EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream.~Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream on the target wound daily up to full closure of that wound were included in the analysis.|||number of unhealed target wounds|||Number
1453568|NCT00825565|Primary|Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage|"A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease spread with weighting factors."|baseline and then every 4 weeks for a total of 12 weeks|Subjects who used allantoin 3% cream for an entire month prior to the BSA monthly assessment were included in the analysis.|||percentage of BSA involvement||Standard Deviation|Mean
1453569|NCT00825500|Secondary|Photophobia Free|Free of Photophobia at 2 Hours Post-treatment|2 hours|ITT with LOCF Population|||Participants|||Count of Participants
1453570|NCT00825500|Primary|Pain-Relief at 2 Hours Post-treatment|Pain-Relief=pretreatment pain rating of 2 (moderate) or 3 (severe) and a rating of 0 (none) or 1 (mild) at the designated assessment time|2 hours|ITT with LOCF Population|||Participants|||Count of Participants
1453571|NCT00825370|Secondary|Changes in Pain Intensity From Baseline to Other Pain Assessment Times (15 and 60 Minutes).|"Mean change in pain intensity between baseline and 15 minutes and between baseline and 60 minutes post treatment. Pain intensity is measured on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The averages were calculated by finding the mean of change in pain intensity for each patient."|Up to 60 minutes||||units on a scale||Standard Deviation|Mean
1453572|NCT00825370|Secondary|Percentage of Patients Who Did Not Want Additional Pain Medication at 60 Minutes|"Patients who did not want pain medication determined by those who answered no to the question do you want more pain medication? at 60 minutes after treatment."|60 minutes||||percentage of participants|||Number
1453573|NCT00825370|Secondary|Percentage of Patients Who Did Not Want Additional Pain Medication at 15 Minutes|"As defined by the percentage of patients who answer no to the question, Do you want more pain medication? at 15 minutes"|15 min||||Percentage of Participants|||Number
1453647|NCT00824564|Secondary|Intra-operative Blood Loss|Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Day 1 (End of surgery)|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||mL||Standard Deviation|Mean
1453579|NCT00825305|Secondary|Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.|Percentages of participants with seroconversion (defined as rabies virus neutralizing antibody concentrations equal and above 0.5 IU/ml) on days 7, 14 and 42.|7 days, 14 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.|||percentages of participants||95% Confidence Interval|Mean
1453580|NCT00825305|Primary|Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination|Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.|7 days after each vaccination|Safety was analyzed for the safety set. One enrolled subject was not vaccinated and not included in the safety set because of inappropriate inclusion.|||participants|||Number
1453581|NCT00825305|Secondary|Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.|Rabies virus neutralizing antibody concentrations the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|7 days and 42 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.|||IU/ml||95% Confidence Interval|Log Mean
1453582|NCT00825305|Primary|Rabies Virus Neutralizing Antibody Concentrations on Day 14.|Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.|14 days|Due to the Chinese registration requirements, only a subset of subjects bloodsamples were drawn and immunogenicity was evaluated. The per protocol population of this subset was analyzed.|||IU/mL||95% Confidence Interval|Log Mean
1453583|NCT00825266|Secondary|NYHA (New York Heart Association Classification) Changes|"New York Heart Classification(NYHA) changes measured at 16 weeks compared with baseline.~NYHA Classification:~NYHA class I:no symptoms and no limitation in ordinary physical activity NYHA class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity, NYHA class IV:Severe limitations. Experiences symptoms even while at rest. {Higher NYHA class represent worse symptoms}"|Baseline and 16 weeks||||NYHA class|||Number
1453584|NCT00825266|Secondary|6 Minute Walk Test|6 minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.It assess the disease severity of the subject at 16 week compared to the baseline.|Baseline and 16 weeks||||meters|||Number
1453585|NCT00825266|Primary|Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio|insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.|baseline and 16 weeks||||ratio|||Number
1453586|NCT00825227|Secondary|Change in the Brief Fatigue Inventory (BFI) Global Score|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)|This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.||||||
1453587|NCT00825227|Secondary|Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire|The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.|Duration of up to 8 weeks total (Screening and Double-Blind)|This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.||||||
1453588|NCT00825227|Primary|Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire|Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.|Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)|Study was discontinued after only 6 subjects were enrolled due to a business decision, so no outcome analysis was done.||||||
1453589|NCT00825175|Primary|Pattern of Gross Motor Development|Age in months at walking development as indicated by the Gross Motor Function Measure, a standardized test of gross motor development.|monthly; starting when child can pull to stand and ending when the test determined that the child was walking.|analysis was on protocol|||months||Standard Deviation|Mean
1453590|NCT00825162|Secondary|Frequency of New Onsets of Chronic Illness||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.|||Participants|||Number
1453591|NCT00825162|Secondary|Frequency of Serious Adverse Events||180 days after the last study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.|||Participants|||Number
1454269|NCT00819247|Secondary|Number of Participants With Normal Prostate-specific Antigen Levels During the Study|The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level).|Weeks 12, 24|Per Protocol Population|||participants|||Number
1453592|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Days||Standard Deviation|Mean
1453593|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Participants|||Number
1453594|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV at Visit 1 and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Days||Standard Deviation|Mean
1453595|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Participants|||Number
1453596|NCT00825162|Primary|Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Days||Standard Deviation|Mean
1453597|NCT00825162|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|UAE stands for Unsolicited Adverse Event.|30 days after each study vaccination|The Safety Population comprised all participants who received CSL's IVV and provided at least one safety assessment after vaccination.|||Participants|||Number
1453598|NCT00825162|Primary|Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)|Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.|7 days post-vaccination|The Safety Population comprised all participants who received CSL’s IVV and provided at least one safety assessment after vaccination. For the safety analysis of solicited AEs after the second vaccination, only those participants who received a second vaccination and provided safety follow-up after the second vaccination were included.|||Participants|||Number
1453599|NCT00824993|Primary|Percentage Change in Bone Mineral Density From Baseline to 6 and 12 Months|The primary outcome measure was the percentage change in BMD in the lumbar spine, femoral neck and total hip at 6 and 12 months (±4 weeks) after allo-SCT relative to baseline.|Baseline to 6 months and Baseline to 12 months|We analyzed changes in BMD from baseline only for those who had follow up BMD evaluated at 6 and 12 months|||Percentage change||Standard Deviation|Mean
1453600|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
1453601|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and is the same for each serotype-specific OPA assay.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
1453618|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate IgG antibody concentration for the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
1453602|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination|Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but ≤39 degrees Celsius (C) (mild), >39 but ≤40 degrees C (moderate), or >40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention).|Baseline up to 4 days after vaccination on Day 1|Safety population; N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).|||percentage of participants|||Number
1453603|NCT00824850|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination|Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (> 7.0 cm). Participants may be represented in >1 category.|Baseline up to 4 days after vaccination on Day 1|Safety population included all participants who received the vaccine. N=number of participants with analyzable data for reactogenicity events (reported Yes for at least 1 day or No for all days).|||percentage of participants|||Number
1453604|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.|||Titer||95% Confidence Interval|Geometric Mean
1453605|NCT00824850|Secondary|Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody titer for the serotypes.|||Titer||95% Confidence Interval|Geometric Mean
1453606|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.|||Mcg/mL||95% Confidence Interval|Geometric Mean
1453607|NCT00824850|Secondary|Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs were calculated using all participants with available data for the specified blood draw. N=number of participants with a determinate OPA antibody concentration for the serotypes.|||Mcg/mL||95% Confidence Interval|Geometric Mean
1453608|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Titer||95% Confidence Interval|Geometric Mean
1453609|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Titer||95% Confidence Interval|Geometric Mean
1454061|NCT00822185|Primary|Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))|Any safety issue was reported as AE|between dosing and 2-3 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.|||number of events|||Number
1453610|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Titer||95% Confidence Interval|Geometric Mean
1453611|NCT00824850|Secondary|Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Titer||95% Confidence Interval|Geometric Mean
1453612|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws. N=number of participants with valid and determinate assay results for both the prevaccination and postvaccination blood draw.|||Mcg/mL||95% Confidence Interval|Geometric Mean
1453613|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 7 (Visit 4)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Mcg/mL||95% Confidence Interval|Geometric Mean
1453614|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population; GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Mcg/mL||95% Confidence Interval|Geometric Mean
1453615|NCT00824850|Secondary|Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5|Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Baseline (Visit 1), Day 28 (Visit 5)|Evaluable Immunogenicity population. GMCs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.|||Mcg/mL||95% Confidence Interval|Geometric Mean
1453616|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 7 (Visit 4)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
1453617|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined OPA antibody titer ≥ serotype-specific lower limit of quantification (LLOQ) using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of participants. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|Day 28 (Visit 5)|Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the serotypes.|||observed percentage of participants||95% Confidence Interval|Number
1453645|NCT00824564|Secondary|Total Blood Loss Assessed by Gross’ Formula|Gross’s formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.|Day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||mL||Standard Deviation|Mean
1453619|NCT00824850|Primary|Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)|Percentage of participants achieving predefined IgG antibody threshold ≥0.35 micrograms per milliliter (Mcg/mL) for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of participants.|Day 28 (Visit 5)|Evaluable Immunogenicity population: eligible participants based on all inclusion and exclusion criteria, had a baseline blood sample collection performed (Visit 1), received 1 dose of 13vPnC, and had Visit 5 blood sample collection performed, and at least 1 valid and determinate assay result at Visit 1 and also at Visit 5.|||observed percentage of participants||95% Confidence Interval|Number
1453620|NCT00824824|Primary|Presence of Retinal Vascular Dysregulation (RVD)|We determined whether RVD was present in the following way. The difference between the retinal blood flow measured while reclining for 30 minutes and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the blood flow while reclining compared to baseline was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ± 2 standard deviations about the mean percentage change found in the control group in the initial study (6.5% ± 24.0%); that is, as -17.5% to +30.5%. Participants with a change in retinal blood flow induced by posture change outside this range were randomized to either dorzolamide-timolol fixed combination BID OU or brimonidine-timolol fixed combination BID OU for 6 weeks.|6 weeks post treatment|21 participants were tested for RVD after 6 weeks of timolol treatment. Of the 21 participants who were tested, 7 had RVD and were randomized to Dorzolamide-Timolol and Brimonidine-Timolol; 14 had normal autoregulation. One participant was removed from the analysis in the Brimonidine-Timolol arm due to technical difficulties with equipment.|||Participants|||Number
1453621|NCT00824772|Secondary|Postoperative Cumulative Fentanyl Consumption||48hr after surgery||||mcg||Standard Deviation|Mean
1453622|NCT00824772|Primary|Postoperative Cumulative Fentanyl Consumption||24 hr after surgery||||mcg||Standard Deviation|Mean
1453623|NCT00824746|Secondary|Overall Survival||2 years||||days||95% Confidence Interval|Median
1453624|NCT00824746|Primary|Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT|Evaluation of treatment response by computed tomography (CT) was performed after the first 4 weeks according to version 1.1 of the guidelines set out by Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Disease control rate (DCR) was defined as the percentage sum of best tumor response of complete response (CR), partial response (PR), and stable disease (SD).|8 weeks|we analysed the data of 23 patients who were enrolled to this study(intention-to-treat (ITT) population).|||percentage of participant with DC||95% Confidence Interval|Number
1453625|NCT00824746|Secondary|Progression - Free Survival of Patients Retreated With Gefitinib|Progression is defined, using RECIST (V1.1), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline using CT scan every 8 weeks.|two year||||days||95% Confidence Interval|Median
1453626|NCT00824733|Secondary|Combination of PF-03512676 and Trastuzumab Induces MIP-1 (Macrophage Inflammatory Protein 1), MCP-1 (Monocyte Chemoattract Protein 1) and RANTES.||up to 18 weeks|The study was terminated early due to poor patient accrual and no data was collected and analyzed.||||||
1453627|NCT00824733|Secondary|Progression-free Survival for Patients With Metastatic Breast Cancer That Are Receiving Trastuzumab Plus PF-03512676|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to 18 weeks||||weeks||Full Range|Median
1453628|NCT00824733|Primary|PF-03512676 Augments Antibody Mediated Cytoxicity (ADCC)Against Trastuzumab-coated Target Cells in Metastatic HER2 Overexpressing Breast Cancer.||up to 18 weeks|Samples were not analyzed for primary endpoint due to the sample numbers being too small. No data were collected from the samples.||||||
1453629|NCT00824720|Primary|Visual Acuity - Left Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days||||logMARs||Standard Deviation|Mean
1453630|NCT00824720|Primary|Visual Acuity - Right Eye|This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|at 14 days||||logMAR units||Standard Deviation|Mean
1453631|NCT00824720|Secondary|Intraocular Pressure (IOP)||from baseline to 14 days|The analysis population includes all subjects with a plug insertion that completed the study per protocol.|||mmHg||Standard Deviation|Mean
1453632|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
1453633|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.|Day 1 through 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
1453646|NCT00824564|Secondary|Post-operative Blood Loss|Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|1, 4, 8 and 24 hours post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||mL||Standard Deviation|Mean
1453634|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
1453635|NCT00824655|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination|Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic|||Percentage of participants|||Number
1453636|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.|12 months of age (prior to toddler dose)|Evaluable Toddler Immunogenicity Population|||mcg/mL||95% Confidence Interval|Geometric Mean
1453637|NCT00824655|Secondary|GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population|||mcg/mL||95% Confidence Interval|Geometric Mean
1453638|NCT00824655|Secondary|Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose|Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 Month after the infant series (6 months of age)|Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1453639|NCT00824655|Primary|Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose|Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
1453640|NCT00824616|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.|From first dose of study drug (Week 0) to last dose of study drug (Week 20)|All Participants as Treated Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo).|||participants|||Number
1453641|NCT00824616|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) Level|HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.|Baseline (Day 1) and End of Treatment (Week 20)|Full Analysis Set Population, which consisted of all randomized participants who took at least one dose of study drug (MK-0941 or Placebo) and had a baseline or post-randomization measurement.|||% HbA1c||95% Confidence Interval|Least Squares Mean
1453642|NCT00824564|Secondary|Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery|DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.|Day 5 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||Participants||95% Confidence Interval|Number
1453643|NCT00824564|Secondary|Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery||Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||gram/deciliter (g/dl)||Standard Deviation|Mean
1453644|NCT00824564|Secondary|Number of Participants Receiving Transfusions|A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent.|Up to day 7 post-surgery|FAS included all participants who were randomized to study treatment and received at least one dose of study medication.|||Participants||95% Confidence Interval|Number
1453648|NCT00824564|Primary|Total Blood Loss|Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.|Baseline through Day 7 post-surgery|Full analysis set (FAS) included all participants who were randomized to study treatment and received at least one dose of study medication.|||Milliliters (mL)||Standard Deviation|Mean
1453649|NCT00824538|Secondary|Effect of Sunitinib Malate on OTC in Peripheral Blood|Data was not collected due to emerging data on toxicity and competing trials.|After one year of treatment|||||||
1453650|NCT00824538|Secondary|Relapse-free and Overall Survival|Data was not collected due to emerging data on toxicity and competing trials.|up to 3 years from beginning of treatment|||||||
1453651|NCT00824538|Secondary|Participants Affected by Toxicities as Assessed by NCI CTCAE v3.0||up to 7 months after start of treatment||||participants|||Number
1453652|NCT00824538|Secondary|Number of Patients Who Are Able to Tolerate Sunitinib Malate for 6 Months and Complete the Study||after 6 months from start of treatment||||participants|||Number
1453653|NCT00824538|Primary|Percent Change From Baseline in Disseminated Tumor Cells (DTC) in Bone Marrow|DTCs were detected by immunomagnetic enrichment and flow cytometry (IE/FC) and measured in cells/mL|Baseline, 6 months after start of treatment||||percentage of change||Full Range|Mean
1453654|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Investigator|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mm||Full Range|Median
1453655|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Parents|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mm||Full Range|Median
1453656|NCT00824512|Secondary|Visual Assessment Scale (VAS) of Global Impression - Patient|The VAS used a 10-cm scoring scale in which values were reported in mm such that 0=bad and 100=good. Total score range on VAS is from 0 to 100.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mm||Full Range|Median
1453657|NCT00824512|Secondary|Choice Reaction Time Test- Movement Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||millisecond||Full Range|Median
1453658|NCT00824512|Secondary|Choice Reaction Time Test- Reaction Time|The choice reaction time test was used to assess cognitive functioning. On random presentation of one of six signal lights, the patient was asked to respond as quickly and accurately as possible by removing their index finger of the dominant hand from the bottom key and pressing whichever of the top six keys was indicated by the signal. Reaction time was the time elapsed between the presentation of the stimulus and the release of the finger and movement time was defined as the time elapsed between release of the finger and pressure of the second key.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||millisecond||Full Range|Median
1453659|NCT00824512|Secondary|Nine Hole Peg Test (Nondominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
1453660|NCT00824512|Secondary|Nine Hole Peg Test (Dominant Hand)|The nine hole peg test was used to assess cognitive function and in particular, fine motor coordination. The patient was asked to place nine pegs in nine holes and was scored on the amount of time it took to place and remove all nine pegs.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
1453661|NCT00824512|Secondary|Timed 25-foot Walk Test||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
1453674|NCT00824512|Secondary|Peak Post Exercise Perfusion|Peak post exercise perfusion (mL/mn/100 g of tissue) was assessed using Arterial spin labelling combined with Nuclear Magnetic Resonance imaging.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||ml/mn/100 g of tissue||Full Range|Median
1453662|NCT00824512|Secondary|ICARS (Oculomotor Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Oculomotor Disorders. Oculomotor Disorders score range from 0 to 6 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
1453663|NCT00824512|Secondary|ICARS (Speech Disorders Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Speech Disorders. Speech Disorders Score range from 0 to 8 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
1453664|NCT00824512|Secondary|ICARS (Kinetic Function Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Kinetic Function. Kinetic Function score range from 0 to 52 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
1453665|NCT00824512|Secondary|ICARS (Posture and Gait Disturbance Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales including Posture and gait disturbances. Posture and gait disturbances score range from 0 to 34 (Higher scores indicate higher levels of impairment).|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
1453666|NCT00824512|Secondary|International Cooperative Ataxia Rating Scale [ICARS] (Total Score)|The ICARS was used to measure the general clinical symptoms of Friedreich ataxia using four subscales (i.e. Posture and gait disturbances, Kinetic functions, Speech disorders, & Oculomotor disorders). Scores for each subscale quantify the extent of ataxia in each clinically important area and subscale scores are also summed to give a total score ranging from 0 to 100, with 100 indicative of the most severely affected outcome.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||score on a scale||Full Range|Median
1453667|NCT00824512|Secondary|Metabolism Efficacy Index|The metabolism efficacy index was derived as Normalised work x creatine phosphorylation rate (sec-1). [Normalised work was derived as Work developed during the exercise/(60 X Maximum cross section of muscle-1100)]. Greater values of Metabolism Efficacy index indicate improvement in skeletal muscle energetics while lower values indicate the reverse. Negative values obtained using the formula indicated severe levels of muscle weakness.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||per second||Full Range|Median
1453668|NCT00824512|Secondary|Normalised Work Developed During the Exercise|"Normalised work developed during the exercise was derived as Work developed during the exercise/([60 X Maximum cross section of muscle]-1100).~Normalised work measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy."|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||Joules/cm^2||Full Range|Median
1453669|NCT00824512|Secondary|Developed Force During the Exercise Bout|Developed force during the exercise bout measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||Joules||Full Range|Median
1453670|NCT00824512|Secondary|Muscle Trophicity: Maximum Cross Section of Muscle|Muscle trophicity measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated based on maximum cross section of muscle (cm^2)|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||cm^2||Full Range|Median
1453671|NCT00824512|Secondary|Muscle Reoxygenation Rate Post Exercise.|Muscle reoxygenation rate post exercise was assessed using Myoglobin Hydrogen-1 Nuclear Magnetic Resonance spectroscopy.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||per second||Full Range|Median
1453672|NCT00824512|Secondary|Perfusion-time Integral During the First 9 Minutes Post Exercise.|The integral of 'peak perfusion' over a period of 9 minutes post exercise.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||mL/100 g of tissue||Full Range|Median
1453673|NCT00824512|Secondary|Time to Peak Perfusion||Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||seconds||Full Range|Median
1453675|NCT00824512|Primary|Creatine Rephosphorylation Rate Post Exercise|Creatine Rephosphorylation Rate post exercise measured using Phosphorus 31 Nuclear Magnetic Resonance (P-31 NMR)spectroscopy and calculated with correction according to muscular pH.|Baseline (Week 0) to Week 12|Due to small sample size and considering there are no specific studies in this population with EGb761; calculation with the use of a statistical hypothesis was not possible. Primary efficacy analyses performed on the mITT population and analysis of safety performed on the safety population.|||pH per second||Full Range|Median
1453676|NCT00824473|Secondary|Change From Baseline on Direct Visual Nasal Exams to 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion,Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days||||Participants|||Number
1453677|NCT00824473|Secondary|Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Scores for a series of subsclaes are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|14 Days||||Units on a Scale||Standard Deviation|Least Squares Mean
1453678|NCT00824473|Secondary|Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible TOSS score is 9 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to14 Days||||Scores on a scale||Standard Deviation|Least Squares Mean
1453679|NCT00824473|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline to 14 Days||||scores on a scale||Standard Deviation|Least Squares Mean
1453680|NCT00824473|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline to 14 Days||||Score on a scale||Standard Deviation|Least Squares Mean
1453681|NCT00824473|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||Scores on a scale||Standard Deviation|Least Squares Mean
1453682|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 5||5 weeks after baseline|"For this Secondary Outcome, FAS population was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had a serum-phosphate measurement at Week 5."|||mmol/L||Standard Deviation|Mean
1453683|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 4||4 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 4."|||mmol/L||Standard Deviation|Mean
1453684|NCT00824460|Secondary|Change From Baseline in Serum-phosphate Levels at Week 2||2 weeks after baseline|"For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).~Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 2."|||mmol/L||Standard Deviation|Mean
1453685|NCT00824460|Primary|Change From Baseline in Serum-phosphate Levels at the End of Treatment.||6 weeks after baseline|For the Primary Outcome, data from the Full Analysis Set (FAS) was used. The FAS consists of all randomised subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).|||mmol/L||Standard Deviation|Mean
1453686|NCT00824434|Secondary|Technical Success|Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.|Acute-At time of index procedure|Intention to treat|||percentage of stents attempted|Participants||Number
1453687|NCT00824434|Secondary|Clinical Procedural Success|Mean lesion diameter stenosis < 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR|Duration of hospital stay (usually 1-2 days)|Analysis was intention to treat|||percentage of participants|||Number
1454062|NCT00822172|Secondary|The Effect of the Combination of Cilostazol and L-carnitine on Claudication Onset Time (COT) and Quality of Life (QOL), as Measured Using the Walking Impairment Questionnaire (WIQ) and SF-36v2® at Days 90 and 180.||Day 0 to Days 90 and 180|||||||
1453688|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453689|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453690|NCT00824434|Secondary|Definite + Probable Stent Thrombosis Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453691|NCT00824434|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453692|NCT00824434|Secondary|Target Lesion Failure (TLF)|Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453693|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453694|NCT00824434|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453695|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453696|NCT00824434|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453697|NCT00824434|Secondary|All-cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453698|NCT00824434|Secondary|Myocardial Infarction (MI)|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453699|NCT00824434|Secondary|Occurance of Post-procedure Incomplete Stent Apposition|Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound|Post-procedure|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) and who underwent intravascular ultrasound to determine extent of stent apposition|||percentage of participants|||Number
1453700|NCT00824434|Secondary|In-stent Late Loss|In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)|9 months|Analysis was intention to treat; all patients in the study with workhorse lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) underwent clinical follow up to provide the information needed for this endpoint.|||millimeters||Standard Deviation|Mean
1453701|NCT00824434|Primary|Cardiac Events (Composite)|Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium [ARC] definitions); see below for definitions of individual components.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453702|NCT00824421|Secondary|Plasma Concentration of Lersivirine at 24 Hour|The observed plasma concentration at 24 hours post-dose (C 24h).|24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who further consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1453703|NCT00824421|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||hr||Full Range|Median
1453704|NCT00824421|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lersivirine||0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4|PKSSAS included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1453705|NCT00824421|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0-24). Only participants from Lersivirine treatment arms were planned to be analyzed for Pharmacokinetic (PK) sub-study.|0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4|Pharmacokinetic sub-study analysis set (PKSSAS) included all randomized Lersivirine participants who consented to participate in the PK sub-study, received the study medication on the day of the PK sub-study and had sufficient PK data for analysis.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1453706|NCT00824421|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, it was deemed that the interpretation of the pharmacokinetic/pharmacodynamic (PK/PD) results would be questionable, thus data was not analyzed.||||||
1453707|NCT00824421|Secondary|Population Pharmacokinetic (PK) of Lersivirine|Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the participant flow and baseline characteristics modules.|Week 2, 4, 8, 12, 16, 24, 32, 40, 48|||||||
1453708|NCT00824421|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included hematology, blood chemistry, serum and urine pregnancy test, hepatitis testing and urinalysis. Laboratory values that met the criteria of the Division of Acquired Immuno Deficiency Syndrome (DAIDS) grade 1 (mild, symptoms causing no or minimal interference with usual social and functional activities) or greater were considered as abnormal.|Baseline up to Week 96 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1453709|NCT00824421|Secondary|Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96|Phenotypic resistance and genotypic resistance was assessed for all participants at Day 1 predose, and was evaluated for nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) resistance-associated mutations at time of treatment failure using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure, up to Week 96.|Day 1 (pre-dose) through Week 24, 48, 96|Virology analysis set (TLOVR50 failures) included all participants who meet the TLOVR50 failure definition. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point for each group, respectively.|||participants|||Number
1453710|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.|||percentage of total lymphocytes||Standard Deviation|Mean
1453711|NCT00824421|Secondary|Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96|Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. No or zero change from baseline was imputed for participants with missing baseline or no CD4+ count available on treatment.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
1453737|NCT00824382|Secondary|Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks|Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol )|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Number of puffs||Standard Error|Mean
1453712|NCT00824421|Secondary|Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response is compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; met treatment failure [TF] criteria). TF: an increase to at least 3 times baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL). TF criteria’s defined above were confirmed by second measurement at least 14 days after first. In 'TLOVR50', '50' denotes the lower limit of quantification (LLOQ) of assay (which is 50 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Missing value was imputed per the TLOVR algorithm.|||percentage of participants|||Number
1453713|NCT00824421|Secondary|Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as area under the curve of HIV-1 RNA levels (log10 copies/mL) from baseline to the time point of interest divided by time period in weeks minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline up to Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation was missing: value calculated to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.|||log10 copies/mL||Standard Deviation|Mean
1453714|NCT00824421|Secondary|Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|For the log 10 scale, all the HIV-1 RNA levels were log 10 transformed prior to the average calculations. Baseline value was calculated as the average of all the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: Last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.|||log 10 copies/mL||Standard Deviation|Mean
1453715|NCT00824421|Secondary|Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=400 copies/mL and were referred to as non-completer = failure.|||percentage of participants|||Number
1453716|NCT00824421|Secondary|Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 24, 96|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.|||percentage of participants|||Number
1453717|NCT00824421|Primary|Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48|Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.|Week 48|ITT population included all randomized participants who received at least 1 dose of study medication. Participants who had been discontinued from the study, were lost to follow-up, or had missing HIV-1 RNA level data at a visit were considered to have HIV-1 RNA levels >=50 copies/mL and were referred to as non-completer = failure.|||percentage of participants|||Number
1453718|NCT00824408|Secondary|Vss of Pemetrexed|Vss - apparent volume of distribution at steady state following IV administration of pemetrexed|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data|||Litres||Geometric Coefficient of Variation|Geometric Mean
1453719|NCT00824408|Secondary|CL of Pemetrexed|CL - total clearance of pemetrexed in plasma after IV administration|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1453720|NCT00824408|Secondary|Cmax of Pemetrexed|Cmax - maximum measured concentration of pemetrexed in plasma|5 minutes before pemetrexed infusion, at the end of the infusion and 1.5 hours (h), 2.5h, 4.5h and 25.5h after the end of pemetrexed infusion|PK set including patients with evaluable data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1453721|NCT00824408|Secondary|Vss of Volasertib|Vss - apparent volume of distribution at steady state following IV administration of volasertib|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data|||Litres||Geometric Coefficient of Variation|Geometric Mean
1453722|NCT00824408|Secondary|Total Clearance (CL) of Volasertib|CL - total clearance of volasertib in plasma after IV administration|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|PK set including patients with evaluable data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1453723|NCT00824408|Secondary|Cmax of Volasertib|Cmax - maximum measured concentration of volasertib in plasma.|5 minutes (min) before the start of Volasertib infusion and 1 hour (h), 2h, 4h, 24h, 168h and 336h after the start of Volasertib infusion|Pharmacokinetic (PK) set, which included all patients in the treated set with volasertib monotherapy or combined with pemetrexed and provided at least 1 blood sample for measurement of volasertib (BI 6727) or pemetrexed. Including patients with evaluable data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1453724|NCT00824408|Secondary|Frequency of Patients With Possible Clinically Significant Abnormalities|Frequency of patients with possible clinically significant abnormalities|From first drug infusion until 21 days after last drug infusion, up to 1100 days|On-treatment for lab|||participants|||Number
1453725|NCT00824408|Secondary|Occurence of DLT|"Occurence of Dose-limiting toxicity (DLT). A DLT was defined as one or more of the following:~treatment-related CTCAE Grade 3 or 4 nonhematological toxicity (except emesis or diarrhea responding to supportive treatment).~treatment-related CTCAE Grade 4 neutropenia for ≥7 days and/or complicated by infection.~CTCAE Grade 4 thrombocytopenia."|Patients were treated for repeated 21-day treatment cycles until disease progression or intolerability of the trial drug, whichever occurred first.|Treated set, run-in phase, first course only|||participants|||Number
1453726|NCT00824408|Secondary|Occurrence and Intensity of AEs Graded According to CTCAE.|All patients were carefully monitored during and after each treatment cycle. Adverse events (AEs) were recorded and were graded according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (CTCAE).|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Treated set, which included all patients who were dispensed and were documented to have taken at least one dose of investigational treatment.|||participants|||Number
1453727|NCT00824408|Secondary|Duration of Overall Response|The duration of overall response was measured from the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since treatment began). The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented. Duration of disease control is presented here.|From the time measurement criteria were met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented|Randomized phase II set|||weeks||Inter-Quartile Range|Median
1453728|NCT00824408|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the duration of time from randomization to time of death.|From randomization until time of death|Randomized phase II set, including only patients who died.|||months||95% Confidence Interval|Median
1453729|NCT00824408|Secondary|Objective Tumor Response, Defined as Complete Response (CR), and Partial Response (PR), Evaluated According to RECIST Criteria.|Objective tumor response, defined as complete response (CR), and partial response (PR), evaluated according to RECIST criteria. Evaluation of target lesions: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Evaluation of nontarget lesions: Complete Response (CR): disappearance of all nontarget lesions.|From first drug infusion until 21 days after last drug infusion, up to 1100 days|Randomized set|||percentage of participants|||Number
1453730|NCT00824408|Primary|Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.|"Disease progression was defined according to the Response Evaluation Criteria in Solid Tumours (RECIST)) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occured first. For patients with known date of progression (or death): PFS [days] = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS [days, censored] = date of last imaging showing no progression - date randomization + 1 day.~The number of participants analysed displays the number of patients with an event (progression)."|From randomization until disease progression or death|Randomized phase II set, which included all patients who were randomized as part of phase II of the study (not the run in phase)|||months||95% Confidence Interval|Median
1453731|NCT00824382|Secondary|AUC0-1,ss|Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1453732|NCT00824382|Secondary|AUC0-1|Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1453733|NCT00824382|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)|Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg|visit at week 4|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1453734|NCT00824382|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg|after first inhalated administration|Treated set which is however restricted to patients with evaluable data for this endpoint (Patients in which all plasma concentration values were below limit of quantification (BLQ), were excluded from the analysis and were not included into the total number of participants affected for this outcome measure)|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1453735|NCT00824382|Secondary|Difference From Baseline in Potassium|Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable.|Baseline, Week 4|Treated set.|||mmol/L||Standard Deviation|Mean
1453736|NCT00824382|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).|4 weeks|Treated set.|||percentage of participants|||Number
1453738|NCT00824382|Secondary|Weekly Mean Evening PEFR After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,~Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter/minute||Standard Error|Least Squares Mean
1453739|NCT00824382|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks|"PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,~Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded."|Week 4|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter/minute||Standard Error|Least Squares Mean
1453740|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.~FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|Baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453741|NCT00824382|Secondary|Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks|"Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.~FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters."|baseline and after 4weeks treatment|The full analysis set (FAS) for 4 weeks treatment period which is however restricted to patients with evaluable data for this endpoint - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453742|NCT00824382|Secondary|FVC Peak(0-3) Response|The change from baseline in FVC peak(0-3) response after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453743|NCT00824382|Secondary|FVC AUC(0-3) Response|"The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.~Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453744|NCT00824382|Secondary|Trough FVC Response at Week 4|The change from baseline in Trough FVC after 4 weeks of treatment|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453745|NCT00824382|Secondary|FEV1 Peak(0-3) Response at 4 Weeks|The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453746|NCT00824382|Secondary|FEV1 AUC(0-3) Response at 4 Weeks|"The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.~Due to normalization the unit is liters."|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453747|NCT00824382|Secondary|Trough FEV1 Response at Week 2|Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication|baseline and after 2 weeks treatment|The full analysis set (FAS) - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453748|NCT00824382|Primary|Trough FEV1 Response at Week 4|The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.|baseline and after 4 weeks treatment|The full analysis set (FAS) for 4 weeks treatment period - analysis with imputation|||Liter||Standard Error|Least Squares Mean
1453749|NCT00824369|Secondary|CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.|||Percentage of total lymphocytes||Standard Deviation|Mean
1453750|NCT00824369|Secondary|Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12|Participant's immunological status assessed by CD4+ lymphocyte count.|Baseline, Month 6 and Month 12|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.|||cells/uL||Standard Deviation|Mean
1453751|NCT00824369|Secondary|Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled in this study. Only available data were used.|||Number of participants|||Number
1453752|NCT00824369|Secondary|Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit|Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.|Baseline, Month 6, Month 12 and Last visit|Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ > 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.|||Number of participants|||Number
1453753|NCT00824369|Primary|Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events|The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.|End of Study visit or the Early Termination visit|Safety population consisted of all participants who were enrolled in this study.|||Number of participants|||Number
1453754|NCT00824291|Secondary|Change From Baseline on Stress and Social Support Scales at Week 12|Stress and Social Support Scales: self-administered rating scale where item 1 is the stress vulnerability scale measuring how much the subject was set back by stressful events on an 11-point scale ranging from 0 (not at all) to 10 (extremely) and item 2 is an 11-point scale ranging from 0 to 100 percent of the amount of support the subject received from relatives and friends.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
1453755|NCT00824291|Secondary|Change From Baseline on Worry Anxiety Tension Scale (WATS) at Week 12|WATS: a self-administered, 3-question rating scale assesses worry, anxiety, and tension. Each item was a visual analog scale on which the participant circles a number from 0 to 10. Higher scores indicated worse function. WATS total score was the sum of the 3 items. If 1 item was missing, the total score would be missing.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
1453756|NCT00824291|Secondary|Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 12|Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
1453757|NCT00824291|Secondary|Change From Baseline on Work and Activities Item of HAM-D17 at Week 12|The Work and Activities Item of the HAM-D17 is item 7 of HAM-D17. Scoring range from 0 to 4.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
1453758|NCT00824291|Secondary|Clinical Global Impressions Scale - Severity of Illness (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale|||Number
1453759|NCT00824291|Secondary|Clinical Global Impression Scale - Improvement (CGI- I) Score at Week 12|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Change = score at observation minus score at baseline.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale|||Number
1453760|NCT00824291|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 12|Participant rated scale was used to assess the effect of the participant’s symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant’s work/social/family life. Individual item scores range from 0 to 10.|At Baseline and Week 12.|ITT, LOCF|||Scores on a scale||Standard Error|Mean
1453761|NCT00824291|Primary|Change From Baseline in Hamilton Depression Scale (HAM-D) at Week 12|HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilt feelings, suicide, sleep disturbances, anxiety levels and weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. Change from baseline: mean at observation minus mean at baseline.|At Baseline and Week 12.|Intent-to-treat (ITT) analysis set, Last Observation Carried Forward (LOCF)|||Scores on a scale||Standard Error|Mean
1453762|NCT00824265|Secondary|Time of Occurrence of Cmax (Tmax) of Ofatumumab|Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4.|Cycle 1 Week 1, Cycle 1 Week 2, Cycle 4|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)|||Hour||95% Confidence Interval|Geometric Mean
1453763|NCT00824265|Secondary|Maximum Concentration (Cmax) and Observed Drug Concentration Prior to the Next Dose (Ctrough) of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab.Cmax and Ctrough were determined. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)|||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
1453764|NCT00824265|Secondary|Mean Area Under the Time-concentration Curve (AUC) Curve Over the Dosing Interval (AUC[0-tau]) of Ofatumumab|Area under the time-concentration curve (AUC) over the dosing interval (AUC[0-tau]) was evaluated. Blood samples were collected from participants who received ofatumumab plus fludarabine and cyclophosphamide predose and 0.5 h after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, predose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, and 6 (Days 29, 57, 113, and 141).|Cycle 1 Week 1, Cycle 1 Week 2, Cycles 2,3,4,5,6|PK Population: Participants for whom a pharmacokinetic sample was obtained were analyzed, only participants available at the specified time points were analyzed(represented by n=X in the category titles)|||hour*nanogram/mililiter (h*ng/mL)||95% Confidence Interval|Geometric Mean
1453765|NCT00824265|Secondary|Mean of Health Change Questionnaire (HCQ)|The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for ‘my health is a great deal better’ to 9 for ‘my health is a great deal worse’ since the beginning of the study. Lower scores represent better conditions.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.|||Unit on a scale||Standard Deviation|Mean
1453766|NCT00824265|Secondary|Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30, a self-reported, cancer-specific instrument assessing 15 domains: physical, role, emotional, cognitive and social functioning, pain,fatigue, nausea and vomiting, insomnia, loss of appetite, constipation, diarrhea, and dyspnea, financial difficulties and a global health status/quality of life (QOF). Functional and symptoms scales were measured on four point Likert scale where 1 = not at all and 4 = very much. Pat. assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Clinically meaningful changes or minimally important differences (MIDs)have been previously established for the EORTC QLQ C30, and categorized as ‘small’ if the mean change in scores is 5-10 points, ‘moderate’ if 10-20 points, and ‘large’ if >20points.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed|||Scores on a scale||Standard Deviation|Mean
1453767|NCT00824265|Secondary|Change From Baseline in Patient Reported Outcome (PRO) as Assessed by EuroQoL Five-Dimension (EQ-5D) Score at Indicated Visit|EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem(s) and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (death) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A Negative health status describes health state worse than death.Baseline is the most recent, non-missing value prior to or on the first study drug dose date.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|ITT Population. Only those participants available at the specified time points were analyzed.|||Score on a scale||Standard Deviation|Mean
1453768|NCT00824265|Secondary|Changes in Patient Reported Outcome (PRO) Measures and Scores for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)|The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales – fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection scale [IS] (4 items) – and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 – 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Cycle 4 Day 1 and during follow-up 1 M and every 3 M up to 24 months. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value was obtained at randomization.|Screening, Cycle 3 Day 1, and 1 M and every 3 month post last dose up to 24 month.|Participants|||scores on a scale||Standard Deviation|Mean
1453769|NCT00824265|Secondary|Prognostic and Biological Markers Correlating With Clinical Response|Blood samples were collected for the assessment of the following prognostic markers at BL: immunoglobulin heavy chain variable region(IgVH) homology; Zeta-Chain-Associated Protein Kinase 70(ZAP70), VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]); beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH included 6q-,11q-, +12q, 17p-, 13q-) , ZAP-70 (positive, negative or intermediate), VH3-21 usage (Yes and No), IgVH homology (>98%, 97%-98% and <97%), beta 2 microglobulin (>3500 microgram per liter [µg/L] and <=3500 µg/L). For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=cytogenetics (CY G).|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1453770|NCT00824265|Secondary|Change From Baseline in Cell Counts, CD5- CD19+|CD5- CD19+ cells were counted by flow cytometry at Screening (baseline) at Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during treatment period and after last dose of study drug at 1 M and then every three month up to 45 M during follow up period. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. Day 1 if available otherwise screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three month up to 45 M during Follow-up Period|Safety Population|||cells/uL||Standard Deviation|Mean
1453780|NCT00824265|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD) Assessed by IRC|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1453771|NCT00824265|Secondary|Change From Baseline in Cluster of Differentiation (CD) Cell Counts, CD5+ and CD19+|CD5+ and CD19+ cells were counted by flow cytometry at Screening (Baseline) on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 during the treatment period and after last dose of study drug at 1 M and then every three month follow up up to 45 M. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline is defined as the assessment closest to but prior to first dose (e.g. day 1 if available, otherwise, screening). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Screening, Cycle 1 Day1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1 and after last dose at 1 M and then every three months up to 45 M during Follow-up Period|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||cells/uL||Standard Deviation|Mean
1453772|NCT00824265|Secondary|Mean Level of Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. Blood samples were collected from each participant and IgA, IgG, and IgM were measured at Baseline, and 1M and 6M after last dose during follow up period.|Baseline, 1M and 6M follow up|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Gram per liter||Standard Deviation|Mean
1453773|NCT00824265|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products or blood supportive care product are included.|From randomization up to 5 years after last dose of study drug|Safety Population|||Participants|||Number
1453774|NCT00824265|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with at least one Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population|||Participants|||Number
1453775|NCT00824265|Secondary|Number of Participants With Drug Related AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population|||Participants|||Number
1453776|NCT00824265|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA)|"AIHA is a condition where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants experienced AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population|||Participants|||Number
1453777|NCT00824265|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result at Indicated Time Points|Serum samples for analysis of HAHA were collected at Baseline (Screening), after 3 cycles were compelted, after 1 M and 6 M post last dose. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive.|From start of study drug until 60 days after the last dose of study medication|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles)|||Participants|||Number
1453778|NCT00824265|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From first dose of study medication to 60 Days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)|Safety Population: Participants who received at least one dose of a study drug.|||Participants|||Number
1453779|NCT00824265|Secondary|Number of Participants Who Were Negative for MRD Assessed by Investigator|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the participants who were suspected of achieving a primary endpoint CR. MDR was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization up to 5 years after last dose of study drug|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1453789|NCT00824265|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the last IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization up to 5 years after last dose of study drug|ITT Population.|||Months||95% Confidence Interval|Median
1453781|NCT00824265|Secondary|Percentage of Participants With the Best OR, as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population|||Percentage of participants|||Number
1453782|NCT00824265|Secondary|Percentage of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population|||Percentage of participants|||Number
1453783|NCT00824265|Secondary|Number of Participants With no B-Symptoms or at Least One B-symptoms Over the Time|Participants with no B-symptoms (B-Sy) (no night sweat, no weight loss, no fever and no extreme fatigue) and at least one indicated B-sy(night sweats, weight loss, fever or extreme fatigue) were presented at Screening, Cycle 1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and during follow up period at 1 M after study drug therapy, then every 3 M up to 5 year (up to 60 months).|Screening, Cycle1 Day 1, Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day 1 and During at 1M after study drug therapy, then every 3 M up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1453784|NCT00824265|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. ECOG performance status are measured at Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1 and Cycle 6 Day1. During follow period, 1 M after study drug therapy, then every 3 month up to 5 year (up to 60 months). Improvement is defined as a decrease from baseline by at least one step on the ECOG performance status scale (yes/no).|Cycle 2 Day1, Cycle 3 Day1, Cycle 4 Day1, Cycle 5 Day1, Cycle 6 Day1, follow up (FU) at 1Month (M) after study drug therapy, then every 3 month up to 5 year (up to 60 months)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
1453785|NCT00824265|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From the start of study drug until the start of the next anti-CLL therapy (up to 5 years after the last dose of study drug)|ITT Population|||Months||95% Confidence Interval|Median
1453786|NCT00824265|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to PD. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From randomization up to 5 years after the last dose of study drug|ITT Population.|||Months||95% Confidence Interval|Median
1453787|NCT00824265|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From time of initial response to disease progression or death, whichever came first (up to 5 years after the last dose of study drug)|ITT Population. Par with unknown or missing responses were considered as non-responders, only responders were included in this analysis.|||Months||95% Confidence Interval|Median
1453788|NCT00824265|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response. Complete Response/remission(CR) all the criteria at least 2 months after last treatment: no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/spleenomegaly/constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. Incomplete bone marrow recovery(CRi): CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. Partial Remission/response(PR): >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. Nodular PR(nPR): persistent nodules BM.|From randomization up to 5 years after last dose of study drug|ITT Population. Participants with unknown or missing responses were considered as non-responders. Only responders were included in the analysis.|||Months||95% Confidence Interval|Median
1453790|NCT00824265|Primary|Progression-free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (progressive disease,PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.|From randomization up to 5 years after last dose of study drug|Intent-to-Treat (ITT) Population: all participants randomized and received study drug.|||Months||95% Confidence Interval|Median
1453791|NCT00824161|Secondary|Overall Survival|Overall survival is defined as the period from the date of first dose of TAS-109 to death date.|From the initial treatment until 12 months after enrollment of the last patient.|Analysis was Intent to Treat(ITT) population.|||months||95% Confidence Interval|Median
1453792|NCT00824161|Secondary|Antitumor Activity|Per RECIST Criteria and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall response rate was defined as percentage of patients of CR plus PR in ITT population.|From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.|Intent to treatment(ITT)|||percentage of CR plus PR patients||95% Confidence Interval|Number
1453793|NCT00824161|Primary|Percentage of Progression Free Survival|The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.|From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.|Analysis was Intent to treatment(ITT) population.|||percentage of PFS patients||95% Confidence Interval|Number
1453794|NCT00824070|Primary|The Aqueous Humor Drug Concentration.|An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.|Visit 2, 1-14 days following screening visit|Statistical Analysis of AH Drug Concentration. Modified intent to treat population (mITT). Subjects with non-missing data.|||µg/mL|Participants|Standard Deviation|Mean
1453795|NCT00824044|Primary|Percent Change in Relative Theta Power From Week 1 of the Ear Channel|Percent change between baseline and week 1 in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4|1 week|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||percent||Standard Deviation|Mean
1453796|NCT00824044|Primary|Change in Relative Theta Power From Ear Channel|Change between baseline and LOCF in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453797|NCT00824044|Primary|Change in Relative Theta Power From Temporal Channel|Change between baseline and LOCF in relative power of the theta wave recorded from the temporal channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The temporal channel refers to the average of channels 1 and 2|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453798|NCT00824044|Primary|Change in Absolute Beta Power From the Ear Channel|Change between baseline and LOCF in absolute power of the beta wave recorded from the ear channel of the EEG. The ear channel refers to the average of channels 3 and 4.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453799|NCT00824044|Primary|Change in Relative Beta Power From Channel 4|Change between baseline and LOCF in relative power of the beetawave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the beta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453800|NCT00824044|Primary|Change in Relative Theta Power From Channel 4|Change between baseline and LOCF in relative power of the theta wave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453801|NCT00824044|Primary|Change in Relative Theta Power Channel 3|Change between baseline and LOCF in relative power of the theta wave recorded from channel 3 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453802|NCT00824044|Primary|Change in Absolute Theta Power From Channel 1|Change between baseline and LOCF in relative power of the theta wave recorded from channel 1 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453803|NCT00824044|Primary|Change in Absolute Beta Power in Channel 4|Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG|12 weeks|EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm|||Hz||Standard Deviation|Mean
1453804|NCT00824044|Primary|Hamilton Depression Rating Scale (HAM-D-17) Scores|The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.|12 weeks|The number of participants for analysis was based on the number of participants who completed treatment (12 weeks of CBT or medication)|||units on a scale||Standard Deviation|Mean
1453806|NCT00824005|Secondary|Incidence of a Major Adverse Cardiac Event|"Incidence of major adverse cardiac events (new MI, rehospitalization for PCI in coronary artery territories that were treated, death, or rehospitalization for acute coronary syndrome and for congestive heart failure).~(Incidence rate)"|Measured at Baseline and Month 6|Incidence of major adverse cardiac events between baseline and 6 months. (Incidence rate)|||events|||Number
1453807|NCT00824005|Secondary|LV Diastolic Dimension|Left ventricular (LV) diastolic dimension as assessed by contrast echocardiography|Measured at Baseline and Month 6|Only participants with both baseline and six month LV diastolic data available are included.|||mL||Standard Deviation|Mean
1453808|NCT00824005|Secondary|Serum BNP Levels in Patients With CHF|Serum b-type natriuretic peptide (BNP) levels in patients with congestive heart failure (CHF). A minority number of patients had pro-BNP collected versus regular BNP; these numbers are reported in the analysis population description.|Measured at Baseline and Month 6|Only participants with both baseline and six month BNP data available are included.|||IUs||Standard Deviation|Mean
1453809|NCT00824005|Secondary|Exercise Time and Level|Exercise time and level as assessed via six minute walk test. (change in number of feet walked)|Measured at Baseline and Month 6|Only participants with both baseline and six month 6 minute walk data available are included.|||feet||Standard Deviation|Mean
1453810|NCT00824005|Secondary|Number of Participants With a Decrease in Anti-anginal Medication|Number of participants with a decrease in anti-anginal medication (nitrates needed weekly)|Measured at Baseline and Month 6|Only participants with both baseline and six month anti-anginal medication data available are included.|||participants|||Number
1453811|NCT00824005|Secondary|Clinical Improvement in NYHA Classification|"Clinical improvement in New York Heart Association (NYHA) classification. The NYHA scale ranges from 1 (best)Mild- no limitation of physical activity due to heart failure to 4 (worst) Severe-Unable to carry out any physical activity without discomfort due to heart failure. Patients receive a rating of 1-4 for their heart failure symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month NYHA class data available are included.|||units on a scale||Standard Deviation|Mean
1453812|NCT00824005|Secondary|Clinical Improvement in CCS Classification (Angina Pectoris)|"Clinical improvement in Canadian Cardiovascular Society (CCS) functional classification of angina pectoris. The CCS scale ranges from Class I (best)able to conduct ordinary daily activity without causing angina to Class IV (worst) Inability to perform any physical activity without discomfort; anginal symptoms may be present at rest. Patients receive a rating of 1-4 for their anginal symptoms. Results reflect the mean change in the total score over time."|Measured at Baseline and Month 6|Only participants with both baseline and six month CCS data available are included.|||units on a scale||Standard Deviation|Mean
1453813|NCT00824005|Secondary|Regional Wall Motion by Echocardiography|Movement of the left ventricular wall measured in mm from baseline to six months.|Measured at Baseline and Month 6|Only participants with both baseline and six month wall motion data available are included.|||mm||Standard Deviation|Mean
1453814|NCT00824005|Secondary|Regional Blood Flow Improvement by MRI (in Eligible Patients)|Regional blood flow improvement as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.||||||
1453815|NCT00824005|Secondary|Regional Wall Motion by MRI (in Eligible Patients)|Regional wall motion as measured by cardiac MRI (in patients who are not contraindicated)|Measured at Baseline and Month 6|The small number of patients without contraindications for MRI (n=17) precluded performing informative analysis on the MRI data.||||||
1453816|NCT00824005|Primary|Change in Reversible Defect Size|Adenosine myocardial perfusion (SPECT) tests were collected at baseline and 6 months to identify change in ischemic (reversible) defects. SPECT imaging was performed at rest and after adenosine infusion over 4 minutes. To enhance the detection of viability on resting images, sublingual nitroglycerin was administered 15 minutes before injecting technetium Tc 99m sestamibi for the resting image.|Measured at Baseline and Month 6|Only participants with both baseline and six month reversible defect data available are included.|||percentage of reversible defect||Standard Deviation|Mean
1453817|NCT00824005|Primary|Change in Left Ventricular End Systolic Volume (LVESV)as Assessed Via Echo|Echocardiographic measurements were performed by an echocardiographic core laboratory. LVESVs were calculated by the modified biplane Simpson method, using myocardial contrast to enhance endocardial definition. To account for patient body surface area, LVESV indices are reported.|Measured at Baseline and Month 6|Only participants with both baseline and six month LVESV data available are included.|||mL/m2||Standard Deviation|Mean
1453818|NCT00824005|Primary|Change in Maximal Oxygen Consumption (VO2max)|The VO2(max) is assessed using the Naughton treadmill protocol.|Measured at Baseline and Month 6|Only participants with both baseline and 6 month VO2max data available are included.|||mL/kg/min||Standard Deviation|Mean
1453819|NCT00823979|Secondary|Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)|Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48|Due to the sparsity of the data, the ability to interpret the pharmacokinetic/pharmacodynamic (PK/PD) results was limited, thus the data was not reported.||||||
1453820|NCT00823979|Secondary|Population Pharmacokinetics (PK) of Lersivirine|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48|||||||
1453821|NCT00823979|Secondary|Number of Participants With Laboratory Test Abnormalities|Laboratory analysis included blood chemistry, hematology and urinalysis.|Baseline up to Week 48 or early termination|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1454063|NCT00822172|Secondary|The Combination of Cilostazol and L-carnitine on PWT Compared to Cilostazol Alone From Baseline/Day 0 to Day 90 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).||Day 0 to Day 90|||||||
1453822|NCT00823979|Secondary|Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48|Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load >500 copies/mL at treatment failure, up to Week 48.|Baseline through Week 48|Virology analysis set included a subset of participants from TLOVR50 failures who had valid genotypic or phenotypic susceptibility testing result and with plasma HIV-1 RNA >500 copies/mL at baseline and treatment failure.|||participants|||Number
1453823|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.|||percentage of total lymphocytes||Standard Deviation|Mean
1453824|NCT00823979|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96|Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
1453825|NCT00823979|Secondary|Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96|TLOVR50 response (50 denotes lower limit of quantification [LLOQ] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure [TF] criteria). TF: an increase of at least (>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL); HIV-1 RNA <1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement >=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.|Week 24, 48, 96|ITT.Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24,48 weeks were considered to have plasma HIV-1 RNA>=50 copies/mL;were referred as failure. Due to early termination of study,decision was made not to derive TLOVR50 responder analysis for Week 96.|||percentage of participants|||Number
1453826|NCT00823979|Secondary|Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|TAD was calculated as (area under the curve of HIV-1 RNA levels [log10 copies/mL] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.|Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: TAD imputed as zero; not discontinued but observation was missing at visit: TAD to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: TAD imputed as zero.|||log10 copies/mL||Standard Deviation|Mean
1453827|NCT00823979|Secondary|Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.|Baseline, Week 24, 48, 96|ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.|||log10 copies/mL||Standard Deviation|Mean
1453828|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24, 48, 96|ITT population. Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24, 48, 96 weeks were considered to have plasma HIV-1 RNA >=400 copies/mL and referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.|||percentage of participants|||Number
1453829|NCT00823979|Secondary|Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Weeks 48, 96|ITT population. Participants who died, discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 48, 96 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.|||percentage of participants|||Number
1453830|NCT00823979|Primary|Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24|Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).|Week 24|ITT population. Participants who died, discontinued, lost to follow-up, switched/changed dose of anti-retro viral (ARV) drug not allowed by protocol, had missing plasma HIV-1 RNA data at 24 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure.|||percentage of participants|||Number
1453904|NCT00823719|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Associated With Neutropenia|Neutropenia is defined as an abnormal decrease in the number of neutrophils (type of white blood cell in blood) in the blood. Febrile neutropenia is the development of fever in participants with neutropenia. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population|||participants|||Number
1453831|NCT00823966|Primary|Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).|"Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies.~Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts.~Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category."|One year|The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.|||participants|||Number
1453832|NCT00823966|Primary|Number of Participants Who Reported Unlisted Adverse Drug Reaction.|Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).|One Year|The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate.|||participants|||Number
1453833|NCT00823901|Primary|Mean Change in Number of Inflammatory Lesions From Baseline to Week 12|The number of inflammatory lesions (papules and pustules) on the face were counted by a dermatologist at baseline and week 12 for each participant. Change in the number of inflammatory lesions is defined as week 12 values minus the baseline values of the participant. Last observation carried forward (LOCF) method was used for missing values.|Baseline, week 12|Intent to treat (ITT) population. Participants who were randomized but only had baseline visit (never began treatment) were excluded from the analysis. Last observation carried forward (LOCF) was also used.|||lesions||Standard Deviation|Mean
1453834|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 54) was the event, and participants who had completed the study were censored.|0-385 days (up to Week 54)|Long-FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
1453835|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."|||participants|||Number
1453836|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||participants|||Number
1453837|NCT00823836|Secondary|Mean Change From Week 0 in Awake Time Spent “On” With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at Week 54 minus On time with troublesome dyskinesias (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||hours||Standard Deviation|Mean
1453838|NCT00823836|Secondary|Mean Change From Week 0 in Percentage of Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at Week 54 minus Off time (proportion) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of time||Standard Deviation|Mean
1453839|NCT00823836|Secondary|Mean Change From Week 0 in Awake Time Spent “Off” at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at Week 54 minus Off time (hours) at Week 0."|Weeks 0 and 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||hours||Standard Deviation|Mean
1453916|NCT00823719|Secondary|Number of Participants With CR, as Assessed by the Investigator|CR is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population|||participants|||Number
1453840|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on percent change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
1453841|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in change from Week 0 in Off time (percentage)."|Week 54|Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
1453842|NCT00823836|Secondary|Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The CGI-I assesses the participant's improvement or worsening of PD from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|Week 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
1453843|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
1453844|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
1453845|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54."|||scores on a scale||Standard Deviation|Mean
1453846|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
1453847|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.|||scores on a scale||Standard Deviation|Mean
1453848|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453973|NCT00823082|Secondary|Need for Blood Products|Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed|During ICU stay (maximum 70 days)|Intent-to-treat set|||Units||Standard Error|Least Squares Mean
1453974|NCT00823082|Secondary|Postoperative Blood Loss in First 12 Hours|Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours|ICU admission through 12 hours post-operative|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.|||mL||Standard Error|Least Squares Mean
1453849|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453850|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|"Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis."|||scores on a scale||Standard Deviation|Mean
1453851|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0."|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453852|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.|Weeks 0 and 54|Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453853|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 (Baseline) in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score.|Week 54|Long-FAS: participants who were included in the FAS and entered into the Long-term Phase. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.|||percentage of participants|||Number
1453854|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
1453855|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.|0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)|Switching-FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
1453856|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||participants|||Number
1453864|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453857|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||participants|||Number
1453858|NCT00823836|Secondary|Mean Change From Week 24 in Awake Time Spent “On” With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 24 on On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 24. Participants who had 0 hour as On time with troublesome dyskinesias at Week 24 were excluded from the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were also not included in the analysis.|||hours||Standard Deviation|Mean
1453859|NCT00823836|Secondary|Mean Change From Week 24 in Percentage of Awake Time Spent “Off” at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 24 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.|||percentage of time||Standard Deviation|Mean
1453860|NCT00823836|Secondary|Mean Change From Week 24 in Awake Time Spent “Off” at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 24 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.|||hours||Standard Deviation|Mean
1453861|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453862|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453863|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453865|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453866|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453867|NCT00823836|Secondary|Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453868|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at Off) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is where PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis."|Week 24 and FAP (from Week 26 up to Week 32)|"Switching-FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values."|||scores on a scale||Standard Deviation|Mean
1453869|NCT00823836|Secondary|"Mean Change From Week 24 in the Japanese UPDRS Part II (at On) Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24."|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453870|NCT00823836|Secondary|Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included.|Week 24 and FAP (from Week 26 up to Week 32)|Switching-FAS: participants who were included in the FAS and progressed to the PR/XR Switching Phase. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.|||scores on a scale||Standard Deviation|Mean
1453871|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
1453872|NCT00823836|Secondary|Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group|The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.|0-175 days (up to Week 24)|FAS. Data were evaluated only at the time point at which they had been collected.|||percentage of participants|||Number
1453873|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at Off) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."|||participants|||Number
1453903|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Hemoglobin Counts|Anaemia is defined as a pathological deficiency in the oxygen-carrying component of the blood, measured in unit volume concentrations of hemoglobin, red blood-cell volume, or red blood-cell number. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population|||participants|||Number
1453874|NCT00823836|Secondary|"Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at On) at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||participants|||Number
1453875|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On time with troublesome dyskinesias is measured as a proportion using the following formula: (Sum of two days On time with troublesome dyskinesias [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time with troublesome dyskinesias is measured using the following formula: On time with troublesome dyskinesias (proportion) at FAP minus On time with troublesome dyskinesias (proportion) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of time||Standard Deviation|Mean
1453876|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||hours||Standard Deviation|Mean
1453877|NCT00823836|Secondary|Mean Change From Week 0 in Percentage of Awake Time Spent “On” at FAP (up to Week 24) in the Non-Inferiority Verification Phase|"On state is defined as the state at which PD symptoms are well controlled by the drug. On time is measured as a proportion using the following formula: (Sum of two days On time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time is measured using the following formula: On time (proportion) at FAP minus On time (proportion) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of time||Standard Deviation|Mean
1453878|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent On at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Mean Change from Week 0 in On time (actual hours) was calculated as On time (hours) at FAP minus On time (hours) at Week 0. Participants who had only one observation for On time were not included in the analysis."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||hours||Standard Deviation|Mean
1453879|NCT00823836|Secondary|"Mean Percent Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Percent change from Week 0 in Off time (proportion) is measured using the following formula: (Change from Week 0 in Off time [proportion]/Off time [proportion] at Week 0) x 100."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percent change||Standard Deviation|Mean
1453880|NCT00823836|Secondary|"Mean Change From Week 0 in Percentage of Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of time||Standard Deviation|Mean
1453881|NCT00823836|Secondary|"Mean Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 0."|Week 0 and FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||hours||Standard Deviation|Mean
1453882|NCT00823836|Secondary|"Percentage of Responders in Percent Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in percent change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of participants|||Number
1453883|NCT00823836|Secondary|"Percentage of Responders in Change From Week 0 in Awake Time Spent Off at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on change from Week 0 in Off time (percentage)."|FAP (up to Week 24)|FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of participants|||Number
1453884|NCT00823836|Secondary|Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The CGI-I assesses the participant's improvement or worsening of PD from Baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.|FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.|||percentage of participants|||Number
1453885|NCT00823836|Secondary|Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453886|NCT00823836|Secondary|Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453887|NCT00823836|Secondary|"Japanese UPDRS Part II (at Off) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP."|||scores on a scale||Standard Deviation|Mean
1453888|NCT00823836|Secondary|"Japanese UPDRS Part II (at On) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug."|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453889|NCT00823836|Secondary|Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.|||scores on a scale||Standard Deviation|Mean
1453890|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part IV total score were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1454052|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Terminal Half-life (t1/2)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to data.|||hours||Geometric Coefficient of Variation|Geometric Mean
1453891|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 24 in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Particpants with only one observation for the part II (at Off) total score were not included in the analysis."|Week 0 and FAP (up to Week 24)|"FAS. Only participants who had Off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis."|||scores on a scale||Standard Deviation|Mean
1453892|NCT00823836|Secondary|"Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase"|"The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the score at Week 0."|Week 0 and FAP (up to Week 24)|"FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part II (at On) total score were not included in the analysis."|||scores on a scale||Standard Deviation|Mean
1453893|NCT00823836|Secondary|Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.|Week 0 and FAP (up to Week 24)|FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part I total score were not included in the analysis.|||scores on a scale||Standard Deviation|Mean
1453894|NCT00823836|Secondary|Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase|Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one measurement for the part III total score were not included in the analysis.|FAP (up to Week 24)|FAS: participants who were progressed to the Non-Inferiority Verification Phase but excluding those who did not have the target indication, those who had not received at least one dose of investigational product, and those whose measured data in efficacy were not available after treatment initiation.|||percentage of participants|||Number
1453895|NCT00823836|Primary|Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.|Week 0 and FAP (up to Week 24)|Per Protocol Set (PPS): participants with exclusion from the Full Analysis Set (FAS) of those violating the study protocol and assessed to be excluded from the assessment of drug efficacy. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2.|||scores on a scale||Standard Deviation|Mean
1453896|NCT00823823|Secondary|Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations|The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.|Up to 4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.|||participants|||Number
1453897|NCT00823823|Primary|Loss of Radius Fracture Reduction|The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.|4 weeks post-randomization|All subjects who completed the four-week follow-up period with no protocol violations.|||participants|||Number
1453898|NCT00823797|Secondary|Overall Survival|*inclusive of subjects still alive at time of last reporting.|Until death or last reported survival||||months||95% Confidence Interval|Median
1453899|NCT00823797|Secondary|Toxic Death|Defined as death that is possibly, probably, or definitely attributed to bendamustine hydrochloride.|Up to 30 days after completion of study treatment||||Participants|||Count of Participants
1453900|NCT00823797|Secondary|PFS|Defined as the time from date of initial therapy to first objective documentation of tumor progression or death.|Up to progression or death, whichever came first, assessed up to 108 months||||months||95% Confidence Interval|Median
1453901|NCT00823797|Primary|PFS-6|Defined as the proportion of patients who remain alive and free of any disease progression at 6 months. PFS over time will be estimated using the Kaplan-Meier method with standard errors estimated using Greenwood's formula.|At 6 months||||Participants|||Count of Participants
1453902|NCT00823719|Secondary|Number of Participants With the Indicated AEs Associated With Decreased Platelet Counts|Thrombocytopenia is defined as an abnormal decrease in the number of platelets in circulatory blood. Pancytopenia is defined as inadequate blood-cell formation by bone marrow, resulting in a lack of all blood-cell types.|Study Day 1 to approximately Study Day 63|Safety Population|||participants|||Number
1454064|NCT00822172|Primary|Safety of Combining Cilostazol With L-carnitine by Evaluating Laboratory Abnormalities and Adverse Events (AEs).||Day 0 to Day 210|||||||
1453905|NCT00823719|Secondary|Number of Participants Who Were Positive and Negative for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|Human anti-human antibodies (HAHA) indicate immune response to the administered human monoclonal antibody in a two-step assay. A positive screening result is confirmed in a second step. Negative Conclusive is subset of Negative and is a negative HAHA test result with an ofatumumab concentration <200 µg/mL in a pharmacokinetic sample collected at the same time as the HAHA sample. Data are presented when a HAHA sample was collected. WD, withdrawal; FU, follow up.|Study Day 1 up to approximately Study Day 63|Safety Population. Data are presented for those participants who contributed a sample.|||participants|||Number
1453906|NCT00823719|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Vss is the apparent volume of distribution when plasma concentrations are measured under steady state conditions. At steady state, the plasma concentration-time profile of the drug is similar after each dose.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population|||Liters||Geometric Coefficient of Variation|Geometric Mean
1453907|NCT00823719|Secondary|Terminal Phase Half-life (t1/2) of Ofatumumab|t1/2 is defined as terminal phase half-life, which is the time required for the amount of the drug in the body to decrease by half.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population|||hr||Geometric Coefficient of Variation|Geometric Mean
1453908|NCT00823719|Secondary|Trough Plasma Concentration (Ctrough) of Ofatumumab Prior to Second Infusion (Cycle 1 Day 8), Third Infusion (Cycle 2), and Last Infusion (Cycle 3)|Ctrough is defined as the trough plasma concentration, which is the measured concentration at the end of a dosing interval (taken directly before the start of the next infusion).|Cycle 1 Day 8 (Study Day 8; up to 8 hours prior to infusion start), Cycle 2 (Study Day 22; up to 7 hours prior to infusion start), Cycle 3 (Study Day 43; up to 6 hours prior to infusion start)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1453909|NCT00823719|Secondary|Maximum Plasma Concentration (Cmax) of Ofatumumab at the First Infusion (Cycle 1 Day 1), Second Infusion (Cycle 1 Day 8), and Last Infusion (Cycle 3)|Cmax is defined as the maximum concentration of drug in plasma samples for the dosing occasion.|Cycle 1 Day 1 (Study Day 1; up to 48 hours), Cycle 1 Day 8 (Study Day 8; up to 24 hours), Cycle 3 (Study Day 43; up to 48 hours)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1453910|NCT00823719|Secondary|Clearance (CL) of Ofatumumab|CL is the clearance of drug from plasma, which is defined as the volume of plasma from which drug is removed per unit time.|Study Day 1 up to Study Day 85 (up to 12 weeks)|Pharmacokinetic Population|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
1453911|NCT00823719|Secondary|Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) of Ofatumumab at the Last Infusion (Cycle 3)|AUC(0-tau) is the area under the plasma concentration-time curve from time zero (0) over the dosing interval, tau, and is a measure of drug exposure. Tau is 21 days (504 hours) in this study.|Cycle 3 (Study Day 43; 3 weeks)|Pharmacokinetic Population. Data for participants who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the number of participants attending each visit. Results are reported by first dose group and combined, as appropriate.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1453912|NCT00823719|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity, AUC(0-inf), of Ofatumumab at the First Infusion (Cycle 1, Day 1) and the Last Infusion (Cycle 3)|AUC is defined as the area under the ofatumumab (Ofa) concentration-time curve as a measure of drug exposure. AUC(0-inf) is AUC from the start of infusion extrapolated to infinite time. Results are reported by first dose group and combined, as appropriate.|Cycle 1 Day 1 (Study Day 1; up to 1 week) and Cycle 3 (Study Day 43; up to 6 weeks)|Pharmacokinetic Population: all participants (par.) exposed to ofatumumab from whom a pharmacokinetic sample was obtained and analyzed. Data for par. who switched chemotherapy regimen are not included in the summaries by chemotherapy after the switch but are included in the total summaries. Data are provided for the par. attending each visit.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1453913|NCT00823719|Secondary|Overall Survival|Overall survival is defined as the interval of time between the date of treatment start and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population|||days||95% Confidence Interval|Median
1453914|NCT00823719|Secondary|Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of treatment start and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments locally by investigators for the disease under study. Disease progression was based on imaging data or clinical assessment data (if radiologic assessment data were not possible or assessment was not performed).|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|PP Population|||days||95% Confidence Interval|Median
1453915|NCT00823719|Secondary|Number of Participants With the Ability to Mobilize at Least 2 Million Cluster of Differentiation (CD)34+ Cells Per Kilogram (kg) From Peripheral Blood|CD34+ cells are a mixture of stem cells and white blood cells of various degrees of maturity. Stem cell mobilization is the process of stimulating the hematopoietic stem cells (CD34+) to move out of the bone marrow and into the bloodstream, where they can be collected via a process called apheresis. Successful mobilization was defined as the collection of >2x10^6 CD34+ cells/kg. Only those participants, who commenced mobilization, following the administration of ofatumumab in combination with either ICE or DHAP combination chemotherapy, were assessed.|During treatment Cycle 2 (Study Days 22-42) and/or Cycle 3 (Study Days 43-63)|Stem Cell Mobilization Population. All participants in the PP Population in whom stem cell mobilization was attempted and CD34+ cell data are available.|||participants|||Number
1453917|NCT00823719|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|Responders with OR included participants with complete response (CR) and partial response (PR). This was based on adequate responses from the investigator assessment after the completion of treatment. CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease from baseline in the sum of the product of the diameters of target lesions.|From Day 14 (Study Day 56) to Day 21 (approximately Study Day 63) of treatment Cycle 3, or earlier in the case of early withdrawal or missing response assessment for Cycle 3|Per protocol (PP) Population: all participants who received at least one dose of ofatumumab. Participants with major protocol deviations that could have impacted the efficacy outcome, and participants not exposed to ofatumumab or without CD20+ aggressive lymphoma were excluded from assessment. CD, cluster of differentiation.|||participants|||Number
1453918|NCT00823615|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|Tested while reading charts at 40 cm with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||LogMAR||Standard Deviation|Mean
1453919|NCT00823615|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity.|After 1 week of wear|Per protocol. Analysis excluded major protocol deviations as determined by masked review.|||LogMAR||Standard Deviation|Mean
1453920|NCT00823472|Secondary|Number of Cumulus Oocyte Complexes Obtained||one year||||oocytes||Standard Deviation|Mean
1453921|NCT00823472|Primary|Proportion of Top Embryos Per OPU.||1 year|ITT|||percentage embryos|||Number
1453922|NCT00823303|Primary|Confirmed Hypercalcemia|Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.|24 week treatment period||||participants|||Number
1453923|NCT00823264|Primary|Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels|We enrolled patients with elevated phenytoin levels into the study with greater than 30 ug/cc. The treatment arm received multiple doses of activated charcoal and the control arm received no activated charcoal. We obtained serum phenytoin levels every 6 hours for 24 hours then once every 24 hours. The time to reach a subtoxic level was determined in each arm by looking at serum phenytoin levels and documenting when it was below 25 ug/cc.|Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours||||hours||Inter-Quartile Range|Median
1453924|NCT00823212|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Acute-At time of index procedure|Analysis was intention to treat (all patients in the study).|||percentage of stents|Stents||Number
1453925|NCT00823212|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death|In hospital|Analysis was intention to treat (all patients in study).|||percentage of participants|||Number
1453926|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453927|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453928|NCT00823212|Secondary|Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)|See above for definitions of MI and TVR|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453929|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453930|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1454053|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Terminal Slope (λz)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||1/h||Geometric Coefficient of Variation|Geometric Mean
1453931|NCT00823212|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453932|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453933|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453934|NCT00823212|Secondary|Target Vessel Revascularization (TVR)|Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453935|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453936|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453937|NCT00823212|Secondary|Target Lesion Revascularization (TLR)|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453938|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453939|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453940|NCT00823212|Secondary|All Death or Myocardial Infarction (MI)|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453941|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1454335|NCT00819052|Secondary|Change From Baseline in VL (HIV-1 Viral Load) at Each Visit||week 48, 60, 72, 84, 96, 108, 120, 132, 144, last available visit|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment, Observed Cases.|||copies/mL||Standard Deviation|Mean
1453942|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453943|NCT00823212|Secondary|Cardiac Death or Myocardial Infarction (MI)|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453944|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453945|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453946|NCT00823212|Secondary|Non-cardiac Death|Defined as a death not due to cardiac causes (see definition of cardiac death above)|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453947|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453948|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453949|NCT00823212|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453950|NCT00823212|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453951|NCT00823212|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453952|NCT00823212|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of patients|||Number
1453953|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453954|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1454054|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Back Extrapolated Estimate of the Initial FVIIa Activity (C0)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
1453955|NCT00823212|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453956|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453957|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453958|NCT00823212|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non–Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453959|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453960|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
1453961|NCT00823212|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||Percentage of participants|||Number
1453962|NCT00823212|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12-month post index procedure|The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.|||percentage of participants|||Number
1453963|NCT00823199|Post-Hoc|Uric Acid Level||Baseline and 4 weeks|2 subjects had missing data|||mg/dL||Standard Deviation|Mean
1453964|NCT00823199|Secondary|Simpson Angus Scale for Parkinsonism|Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)|baseline and 4 weeks||||score on scale||Standard Deviation|Mean
1453965|NCT00823199|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia|Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)|baseline and 4 weeks|Two subjects withdrew before the first week's evaluation|||scores on a scale||Standard Deviation|Mean
1453966|NCT00823095|Secondary|The Secondary Endpoint Measure is a Reduction on Wound Size.|reduction in bioburden as assessed by number of cfu's per cm2 on culture|28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform analysis.||||||
1453967|NCT00823095|Primary|The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.||at 28 days post enrollment|Data not available for this study due to dissolution of company contracted to perform study analysis||||||
1453968|NCT00823082|Secondary|Length of Hospital Stay|Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.|During ICU stay (maximum 70 days)||||days||Inter-Quartile Range|Median
1453969|NCT00823082|Secondary|Mechanical Ventilation Duration||During ICU stay (maximum 70 days)|Intent-to-treat set|||Days||Inter-Quartile Range|Median
1453970|NCT00823082|Secondary|Percentage of Subjects With Renal Dysfunction|Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to >2.0 and twice the baseline level or need for renal replacement therapy|During ICU stay (maximum 70 days)|Intent-to-treat set|||Percentage of participants|||Number
1453971|NCT00823082|Secondary|Percentage of Subjects With Low Cardiac Syndrome|Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump|During ICU stay (maximum 70 days)|Intent-to-treat set. Three subjects in the Antithrombin III treatment group and 1 subject in the Control group were missing this data.|||percentage of participants|||Number
1453972|NCT00823082|Secondary|Percentage of Subjects Needing Surgical Re-exploration|Percentage of subjects needing surgical re-exploration resulting from bleeding|During ICU stay (maximum 70 days)|Intent-to-treat set. Two subjects in the Antithrombin III treatment group and 2 subjects in the Control group were missing this data.|||percentage of participants|||Number
1453975|NCT00823082|Secondary|Heparin Resistance|Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time >450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses|Immediately after anesthesia induction|Intent-to-treat set. One subject in the Antithrombin III treatment group was missing this data.|||percentage of participants|||Number
1453976|NCT00823082|Secondary|In-hospital Postoperative Mortality||70 days after ICU admission (maximum)|Intent-to-treat set. One subject in the control group was missing this data.|||percentage of participants|||Number
1453977|NCT00823082|Secondary|ICU Stay Duration||During ICU stay (maximum 70 days)|Intent-to-treat set. One subject in the control group was missing this data.|||days||Inter-Quartile Range|Median
1453978|NCT00823082|Secondary|Percentage of Patients With Thromboembolic Events|Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism|During ICU stay (maximum 70 days)|Intent-to-treat set|||percentage of participants|||Number
1453979|NCT00823082|Secondary|Percentage of Subjects With Adverse Neurologic Outcome|Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation|During ICU stay (maximum 70 days)|Intent-to-treat set|||percentage of participants|||Number
1453980|NCT00823082|Secondary|Percentage of Subjects With Postoperative Myocardial Infarction|Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram|During ICU stay (maximum 70 days)|Intent-to-treat set|||percentage of participants|||Number
1453981|NCT00823082|Primary|Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission|Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission|ICU admission|Intent-to treat set and Per-protocol set|||percentage of participants|||Number
1453982|NCT00823082|Primary|Postoperative ATIII Levels at the ICU Admission|Measurement of postoperative ATIII functional activity at ICU admission|ICU admission|Intent-to-treat set and Per-protocol set|||IU||Standard Deviation|Mean
1453983|NCT00823069|Secondary|Number of Subjects Showing Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline||||Participants|||Number
1453984|NCT00823069|Primary|Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm||After Injection on Day of Treatment|This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark.|||Participants||95% Confidence Interval|Number
1453985|NCT00823043|Primary|Subject Reported Blurred Vision|Subjects reported their vision was blurred after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation||||Units on a Scale||Standard Deviation|Mean
1453986|NCT00823043|Primary|Subject Reported Light Sensitivity|Subjects reported light hurt their eyes after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation|Analysis includes all subjects that answered this question. One subject from each arm did not answer this question.|||Units on a Scale||Standard Deviation|Mean
1453987|NCT00823043|Primary|Subject Reported Tearing|Subjects reported tearing after they put the drops in their eyes using the following scale:0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation.||||Units on a Scale||Standard Deviation|Mean
1453988|NCT00823043|Primary|Subject Reported Burning/Stinging|Subjects reported burning/stinging after they put the drops in their eyes using the following scale: 0=never, 1=rarely, 2=sometimes, 3=frequently, 4=always.|Upon instillation||||Units on a Scale||Standard Deviation|Mean
1453989|NCT00822926|Secondary|NRS Score Three Weeks After Injection|Pain scores were measured at baseline, 3 weeks after placebo, and 3 weeks after botox. Scores range from 0 (no pain) to 10 (severe, disabling pain).|3 weeks after injection|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.|||Units on a scale||Standard Deviation|Mean
1453990|NCT00822926|Secondary|Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines|The Beck Depression Inventory was used to assess psychosocial function. Scores were measured at baseline, their final questionnaire following the first injection visit, and their final questionnaire following their second injection visit. Scores range from 0-63, with lower scores representing less severe depression symptoms and higher scores representing more severe depression symptoms.|Duration of trial (2-20 months, depending on how long pain relief lasts)|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.|||Units on a scale||Standard Deviation|Mean
1453991|NCT00822926|Primary|Time to Analgesic Failure|Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.|Duration of trial (2-20 months, depending on how long pain relief lasts)|A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.|||days||Standard Deviation|Mean
1454055|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
1453992|NCT00822900|Secondary|Potentially Associated Adverse Events: Myocardial Infarction (MI)|Myocardial infarction - Events were defined based on serial cardiac enzyme elevation consistent with MI and/or new ST elevation on electrocardiogram (ECG) consistent with MI. Potentially associated adverse events (those events which are included as outcome measures) were specifically defined per the protocol, and the classification of an event as a PAAE was determined by the site. The reported name of the associated event, however, was subject to clinical judgement and case details; these were then further coded by the Principal Investigator. Since these data points do not share the same definition, there is no reason to expect perfect concordance. (For example, the potentially associated adverse event of myocardial infarction may include MedDRA codes other than myocardial infarction.)|within 6 months||||participants|||Number
1453993|NCT00822900|Secondary|Potentially Associated Adverse Events: Central Nervous System (CNS) Infection|CNS infection - Events must have met Centers for Disease Control and Prevention (CDC) definition of CNS infection. The definition includes intracranial infection, Meningitis, ventriculitis, and spinal abscess without meningitis.|within 6 months||||participants|||Number
1453994|NCT00822900|Secondary|Potentially Associated Adverse Events: Pneumonia|Events must have met Centers for Disease Control and Prevention (CDC) definition of pneumonia. There are three specific types of pneumonia: clinically defined pneumonia, pneumonia with specific laboratory findings, and pneumonia in immunocompromised patients. There are specific algorithms to identify each pneumonia, which include x-ray findings, fever with no other cause, leukopenia or leukocytosis, altered mental status with no other cause (adults >70 years old), new onset of purulent sputum, change in character of sputum, increase respiratory secretions, increase suctioning requirements, new onset or worsening cough, dyspnea, tachypnea, rales, bronchial breath sounds, or worsening gas exchange, increased oxygen requirements, or increased ventilator demand). Also, labs can identify pneumonia such as positive growth in blood culture, positive Gram stain, and histopathologic exam evidence.|within 6 months||||participants|||Number
1453995|NCT00822900|Secondary|Potentially Associated Adverse Events: Sepsis|Sepsis - Events must have met Centers for Disease Control and Prevention (CDC) definition of sepsis. The definition includes that a patient ≤1 year of age has at least 1 of the following clinical signs or symptoms with no other recognized cause: fever (>38°C rectal), hypothermia (<37°C rectal), apnea, or bradycardia, and blood culture not done or no organisms detected in blood and no apparent infection at another site and physician institutes treatment for sepsis.|within 6 months||||participants|||Number
1453996|NCT00822900|Secondary|Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level|Unexplained increased liver enzymes (e.g. not due to liver injury ) - Events were defined based on aspartate transaminase (AST) and alanine transaminase (ALT) levels > 500 U/L and/or total bilirubin levels > 2.0 mg/dL.|within 6 months||||participants|||Number
1453997|NCT00822900|Secondary|Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)|DVT - Events were defined based on a positive Doppler ultrasound exam|within 6 months||||participants|||Number
1453998|NCT00822900|Secondary|Potentially Associated Adverse Events: Acute Ischemic Stroke|Acute ischemic stroke - Events were defined based on either positive computed tomography (CT) scanning, magnetic resonance imaging (MRI), or neurologist diagnosis of cerebrovascular accident (CVA)|within 6 months||||participants|||Number
1453999|NCT00822900|Secondary|Potentially Associated Adverse Events: Pulmonary Embolism|Pulmonary embolism - Events were defined based on either positive chest computed tomography (CT) scanning or ventilation/perfusion lung scan (V/Q).|within 6 months||||participants|||Number
1454000|NCT00822900|Secondary|Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis|Phlebitis/Thrombophlebitis (not due to infiltration or misplacement of the IV)|within 6 months||||participants|||Number
1454001|NCT00822900|Secondary|Disability Rating Scale|A measure of functional impairment, with complete recovery scored a 0 and vegetative state scored a 29.|6 months||||units on a scale||Standard Deviation|Mean
1454002|NCT00822900|Secondary|Mortality||6 months||||participants|||Number
1454003|NCT00822900|Primary|Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)|A measure of functional recovery: A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. Favorable outcome was defined via stratified dichotomy based on the severity of the initial injury. For subjects with a severe injury, a GOS-E of 3 or higher were considered to be a favorable outcome; for subjects with moderate-to-severe injury, a GOS-E of 5 or higher was considered to be a favorable outcome; for subjects with a moderate injury, a GOS-E of 7 or higher was considered to be a favorable outcome.|6 months post randomization|The primary analysis was conducted according to intention to treat.|||participants|||Number
1454004|NCT00822770|Secondary|Response Rate (Engraftment Versus Graft Failure)|Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.|100 Days post engraftment|||||||
1454005|NCT00822770|Secondary|Time to Failure|Time to treatment failure defined as either disease recurrence or death, measured in months.|Baseline till disease progression/death, up to 1 year.|||||||
1454006|NCT00822770|Primary|Maximum Tolerated Dose (MTD) Plerixafor|MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).|28 day cycle (Plerixafor Day -7 to Day -4)||||mg/kg|||Number
1454007|NCT00822757|Other Pre-specified|GMFR in Antibody Concentration From Baseline|An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.|Prevaccination to Days 10, 14, 28, and 84 postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1454056|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
1454008|NCT00822757|Other Pre-specified|GMFR by Age|Participants whose geometric mean fold–rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.|Prevaccination to 14 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1454009|NCT00822757|Primary|Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).|Participants whose geometric mean fold–rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).|Prevaccination to 14 days postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1454010|NCT00822692|Primary|Recurrence Rates of Abscesses|Number of patient with a new abscess in same or different location as previous lesion|30 days after incision and drainage||||participants|||Number
1454011|NCT00822679|Secondary|Changes in Objective and Subjective Measures of Sleep||4 days|||||||
1454012|NCT00822679|Primary|Changes in Circulating Inflammatory Cytokines (Interleukin [IL]-1B, IL-6, IL-10, and Tumor Necrosis Alpha [TNF-α]) and Pro-coagulant Mediators (Soluble P-selectin and CD40 Ligand).|Not performed. Zero subjects were randomized. Many potential participants screen-failed.|2 days|Not performed. Zero subjects were randomized. Many potential participants screen-failed.||||||
1454013|NCT00822588|Primary|Number of Participants in Need for Bank Blood Transfusion|"Bank blood transfusions were given in both groups after assessment of independent assessor, by using a transfusion trigger. All transfusions were recorded in a transfusion log and summarized at discharge. The total number of patients per group in need for any bank blood transfusion was compared.~The participant were followed for the duration of hospital stay, an average of 6 days (SD 3 days)"|At discharge|Per protocol group. Major protocol deviations were excluded: Incorrect treatment, no treatment or exclusion criteria fulfilled.|||Participants|||Number
1454014|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454015|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454016|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454057|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)|AUC0-inf = AUC0-t + (Ct / λz), Where Ct is the last quantifiable activity and t the time of Ct.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
1454017|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454018|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454019|NCT00822523|Secondary|"Correlation in Percent Change of the CMAP (With Inactive Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window)."|"Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in an inactive location at the ipsilateral medial malleolus after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used."|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454020|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454021|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454059|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)|AUC0-t was computed using the linear trapezoid rule. Plasma FVIIa clot activity at time 0 was calculated by log linear interpolation.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
1454022|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Mean Rectified Voltage With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Mean Rectified Voltage with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454023|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 200 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 200 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454024|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 500 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 500 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454025|NCT00822523|Secondary|Percent Change of the Surface Electromyogram (SEMG) MRV-500 From EDB After vs. Before Botulinum Toxin Injection Into EDB.|Measure the percent change of the Surface Electromyogram (SEMG) as measured by the Mean Rectified Voltage (MRV) with a window of 500 ms from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A or placebo. Each MRV represents the mean of 3 individual measurements of the MRV at that timepoint with measurements at least 60 seconds apart. In order to facilitate comparison from one subject to the next, the MRV is then converted into percent change from baseline for that subject.|Baseline (mean of 3 measurement on the same day of testing) then following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4||||percent change from baseline||Standard Deviation|Mean
1454026|NCT00822523|Secondary|Correlation in Percent Change of the CMAP (With Standard Reference Electrode Location) From EDB After vs. Before Botulinum Toxin Injection Into EDB vs. Percent Change Surface Electromyography (as Measured by Root Mean Squared With 1000 ms Window).|Measure the percent change of the Compound Muscle Action Potential (CMAP) Amplitude from extensor digitorum brevis (EDB) with the reference electrode in the standard location at the base of the ipsilateral 5th toe after injection of BoNT/A into EDB compared with before injection of BoNT/A. Each CMAP represents the mean of 3 individual measurements of the CMAP at that timepoint. In order to facilitate comparison from one subject to the next, the CMAP is then converted into percent change from baseline for that subject. CMAP percent change is then correlated with the percent change in the Surface Electromyography as measured by the Root Mean Squared with 1000 millisecond window at the same time points after injection. Group with injection of 20 units BoNT/A is used.|Mean of 3 measurements on the same day of testing following single injection of botulinum toxin into EDB with testing at Day 4; Day 14; and Month 4 each compared with Baseline measurement|Analysis of the 2 Units Botox and placebo arms was to be done only if the arm with 20 Units Botox showed significant changes in the strain gauge measurements.|||percent change from baseline||Standard Deviation|Mean
1454027|NCT00822523|Secondary|Number of Participants With Serious Adverse Effects to onabotulinumtoxinA (Botulinum Type A Neurotoxin)||At each visit for nerve conduction studies following injection of onabotulinumtoxinA (botulinum type A neurotoxin) into EDB (Day 0; Day 4; Day 14; Month 4)||||participants|||Number
1454058|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)|Blood samples were collected at following time points: -30 min, -20 min, -10 min, 5 min, 10 min, 20 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 8h, 12h and 24h to calculate area under the curve.|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||(IU*h)/mL||Geometric Coefficient of Variation|Geometric Mean
1454028|NCT00822523|Secondary|Difference in Force From Day 14 to Day 21|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A). The force at each day of testing was the mean of the 3 values for force obtained on that day. Value is percent change from baseline. Comparison is made between the percent change from baseline force and the force on Day 14 in each group vs. the percent change from baseline force and the force on Day 21 in each group.|Force measured at Day 14 after BoNT/A injction into EDB and Force measured at Day 21 after BoNT/A injction into EDB.||||percent change from baseline||Standard Deviation|Mean
1454029|NCT00822523|Secondary|Stability of Baseline Measurements of Force|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge on three different days prior to injection of BoNT/A or placebo. On each of the three days of baseline testing, the force was defined as the mean of three different measurements, separated by at least 1 minute from another measurement.|Baseline 1 (mean of 3 measurement on the same day of testing) compared with Baseline 2 (mean of 3 measurement on the same day of testing) on a second day compared with Baseline 3 (mean of 3 measurement on the same day of testing)|Normal controls at baseline before BoNT/A injected|||kg||Standard Deviation|Mean
1454030|NCT00822523|Primary|"Change in Measured Force (Change From Baseline) (Using Strain Gauges) of Dorsiflexion of Digits 2 and 3 (Force of EDB) After vs. Before Botulinum Toxin Injection Into EDB"|The force of dorsiflexion of the combination of digits 2 and 3 (at the same time using a single loop) of the foot were measured using a strain gauge after and before the administration of Botulinum Neurotoxin type A (BoNT/A) or placebo. The baseline value was the mean of the 3 values for force obtained prior to injection of BoNT/A. The baseline was compared with the subsequent values.|Baseline (3 times) then following single injection of botulinum toxin into EDB with testing at Day 1, Day 2, Day 4, Day 14, Day 21, and Month 4||||kg||Standard Deviation|Mean
1454031|NCT00822510|Primary|Spiritual Well Being|Measures if spiritual beliefs using a 7-item scale that ranges from 7-70. Higher score equals greater spiritual wellbeing.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
1454032|NCT00822510|Primary|Social Well Being|Measures social well-being using the 9 item Social Well-being scale, ranging from 9-90. Higher score indicates increased social well-being.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
1454033|NCT00822510|Primary|Multidimensional Fatigue Inventory|Measure of physical well-being, specifically fatigue, using the Multidimensional Fatigue Scale. Scores range from 0-80 with higher scores indicative of more fatigue.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
1454034|NCT00822510|Primary|Negative Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
1454035|NCT00822510|Primary|Positive Affect|Positive and Negative Affect Scale is a 20 item scale that measures positive and negative affect subscales. Scores range from 10-50 on each subscale with higher score indicating more positive affect.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
1454036|NCT00822510|Primary|Perceived Stress|Perceived stress scale is a 10-item scale with a range of 0-40. Higher scores indicate more stress.|3 points in time, baseline, second assess (T1-8week), 3rd assessment (T2+8 weeks)||||units on scale||Standard Deviation|Mean
1454037|NCT00822510|Primary|Center for Epidemiological Studies-Depression Scale|Depression was measured by the 20-item Center for Epidemiological Studies-Depression (CES-D) scale, Range is 0-60. Scores are added together with higher score greater depression.|3 points in time, baseline, T2=T1+8 weeks, T3=T2 plus 8 weeks|Badger, T.A., Segrin, C., Figueredo, A.J., Harrington, J., Sheppard, K., Passalacqua, S., Pasvogel, A., & Bishop, M. (2011) Psychosocial Interventions to Improve Quality of Life in Prostate Cancer Survivors and their Intimate or Family Partners. Quality of Life Research. 20 (6), 833-844 [epub Dec 2010]. PMID: 21170682; PMCID: PMC3117079|||units on scale||Standard Deviation|Mean
1454038|NCT00822354|Primary|Raynaud's Condition Score (RCS) Visual Analog Scale (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents no difficulty with Raynaud's disease, and 100 mm (right boundary) represents extreme difficulty with Raynaud's disease. The subject makes a vertical mark on the VAS to indicate difficulty experienced that day with Raynaud's disease. The RCS is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.|||millimeters||Full Range|Median
1454039|NCT00822354|Secondary|Capillary Diameter|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 8, Baseline/Week 0 data was used for both Pre-treatment and Pre-placebo, and Week 2 data was used for Week 4 of placebo.|||micrometers||Full Range|Median
1454060|NCT00822185|Primary|Subjects With Anti-Vatreptacog Alfa Antibody|Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody|between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing|Safety analysis set included all the randomised subjects who received at least one dose of the trial product.|||participants|||Number
1454040|NCT00822354|Secondary|Digital Blood Pressure|Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 10, Week 2 data was used for Week 4 of placebo because digital blood pressure data was not obtained at the Week 4 visit.|||mm Hg||Full Range|Median
1454041|NCT00822354|Primary|Raynaud Severity Visual Analog Score (VAS)|The VAS is a 100 millimeter (mm) line where 0 mm (left boundary) represents Raynaud's disease of low severity, and 100 mm (right boundary) represents extremely severe Raynaud's disease. The subject makes a vertical mark on the VAS to indicate the severity of Raynaud's disease over the past two weeks. The Raynaud's severity score is the distance from the left boundary to the vertical mark in mm. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study.|||millimeters||Full Range|Median
1454042|NCT00822354|Primary|Duration of Raynaud's Phenomenon Attacks|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day and the duration of each attack. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.|||minutes||Full Range|Median
1454043|NCT00822354|Primary|Number of Raynaud's Phenomenon Attacks Per Day|Subjects kept a daily record of the number of Raynaud's phenomenon attacks they experienced per day. Results are reported from data collected at Baseline/Week 0, Week 4, Week 5, and Week 9 visits. In subjects receiving tadalafil followed by placebo: Baseline/Week 0 data is Pre-treatment, Week 4 data corresponds to Week 4 of treatment, Week 5 data is Pre-placebo, and Week 9 data corresponds to Week 4 of placebo. In subjects receiving placebo followed by tadalafil: Baseline/Week 0 data is Pre-placebo, Week 4 data corresponds to Week 4 of placebo, Week 5 data is Pre-treatment, and Week 9 data corresponds to Week 4 of treatment.|9 weeks|Two of the ten enrolled subjects were excluded from analysis: one subject due to early withdrawal, and a second subject to avoid bias due to bilateral subclavian stent placement midway through the study. For subject 2, Week 5 data was used for both Pre-treatment and Pre-placebo because Baseline/Week 0 visit data was not obtained.|||Raynaud's attacks per day||Full Range|Median
1454044|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.~Clostridium perfringens was cultured.Bacterial colonies were counted."|week 0, 1, 2, 3, 4, 5, 6.||||log10 CFU/g||Standard Deviation|Log Mean
1454045|NCT00822328|Secondary|Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota|"Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.~Bacterial colonies were cultured and counted."|at week 0, 1, 2, 3, 4, 5, 6||2009-03-31|03/2009||||
1454046|NCT00822328|Primary|Modification of the Composition of the Intestinal Microflora: Bifidobacterium|Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.|week 0, 1, 2, 3, 4, 5, 6.|The number of participants for analysis was per protocol analysis.|||log10 CFU/g||Standard Deviation|Log Mean
1454047|NCT00822237|Primary|Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).|"Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL.~Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only."|6 weeks following first vaccination|Per protocol population|||Percent of participants|||Number
1454048|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Mean Residence Time (MRT)|Mean residence time of the unchanged drug in the systemic circulation|during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. One (1) subject did not contribute to PK evaluation.|||hours||Geometric Coefficient of Variation|Geometric Mean
1454049|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Initial Volume of Distribution (VD)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1454050|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Apparent Volume of Distribution at Steady State (Vss)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subject did not contribute to PK evaluation.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
1454051|NCT00822185|Secondary|Vatreptacog Alfa Clot Activity- Total Clearance (CL)||during 1-2 days after drug administration|PK analysis set included all the subjects not violating the protocol in a manner that was judged to affect PK endpoint evaluation. Two (2) subjects did not contribute to data.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
1454065|NCT00822172|Primary|The Effect of Cilostazol Combined With L-carnitine on Change in Peak Walking Time (PWT) Compared to Cilostazol Alone From Baseline/Day 0 to Day 180 in Subjects With Peripheral Artery Disease (PAD) Limited by Intermittent Claudication (IC).||Day 0 to Day 180|The mITT population included all randomized subjects who received at least 1 dose of study medication and completed at least 1 post randomization Exercise Treadmill Test (ETT).|||minutes||Standard Deviation|Log Mean
1454066|NCT00822120|Secondary|Number of HIV-positive Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year|Eligible HIV-positive patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
1454067|NCT00822120|Secondary|Complete and Partial Response Rates for HIV-positive Patients Treated With Response-Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD|Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|7 months after registration|Eligible and evaluable HIV-positive patients who treated with 2 initial cycles of ABVD followed by response-adapted therapy based on interim FDG-PET imaging were included he analysis.|||Participants|||Count of Participants
1454068|NCT00822120|Secondary|Percentage of HIV-positive Patients With 5-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging.|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|5 years|Eligible and evaluable HIV-positive patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of participants||95% Confidence Interval|Number
1454069|NCT00822120|Secondary|Percentage of HIV-positive Patients With 2-year Progression-free Survival (PFS) Treated With Initial 2 Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is >1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|2 years|Eligible and evaluable HIV-positive patients who started the initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of patients||95% Confidence Interval|Number
1454070|NCT00822120|Secondary|Number of HIV-negative Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year|Eligible HIV-negative patients who had received any treatment were included in the adverse event summaries. Six interim PET-positive patients who did not receive BEACOPP were excluded. patients Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Count of Participants
1454071|NCT00822120|Secondary|Complete and Partial Response Rates for HIV-negative Patients Treated With Response- Adapted Therapy Based on FDG-PET Imaging After 2 Cycles of ABVD|Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|7 months after registration|Only eligible and evaluable HIV-negative patients who treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of ABVD were included in the analysis|||percentage of patients||95% Confidence Interval|Number
1454072|NCT00822120|Secondary|Percentage of HIV-negative Patients With 2-year Overall Survival (OS) Treated With 2 Initial Cycles of ABVD Followed by Response-Adapted Therapy Based on Interim FDG-PET Imaging|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|2 years|Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of participants||95% Confidence Interval|Number
1454144|NCT00820573|Primary|Objective: Comparisons of the Effects of Co-administration of Sitagliptin and Metformin Alone or in Combination Versus Placebo on Baseline Endogenous Glucose Production (EGP).|Baseline endogenous glucose production prior to a mixed meal tolerance test (placebo) and following 6 weeks of either sitagliptin, metformin or sitagliptin plus metformin combination therapy in all 16 participants|6 weeks||||mg/kg.min||Standard Error|Mean
1454073|NCT00822120|Primary|Percentage of HIV-negative Patients Who Are PET-positive After 2 Cycles of ABVD With 2-year PFS|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|2 years|Eligible and evaluable HIV-negative patients who were PET-positive after 2 cycles of ABVD were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1454074|NCT00822120|Primary|Percentage of HIV-negative Patients With 2-year Progression-free Survival (PFS) Treated With 2 Initial Cycles of Adriamycin, Bleomycin, Vnblastine, and Dacarbazine (ABVD) Followed by Response-adapted Therapy Based on Interim FDG-PET Imaging.|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|2 years|Eligible and evaluable HIV-negative patients who started initial ABVD were included in the analysis regardless the response-adapted therapy after 2 initial cycles of ABVD was administered.|||percentage of participants||95% Confidence Interval|Number
1454075|NCT00822094|Secondary|Rate of Stem Cell Transplant|Number of patients transferred for stem cell transplant|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
1454076|NCT00822094|Secondary|Rate of Aplasia|Patients with Aplasia During Study|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
1454077|NCT00822094|Secondary|Remission Duration|Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.|Following achievement of CR and up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||days||Full Range|Median
1454078|NCT00822094|Secondary|Event Free Survival|Progression EFS median|Up to 1 year from randomization|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
1454079|NCT00822094|Secondary|Complete Remission Rate||Following 1st induction, following 2nd induction if applicable|Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
1454080|NCT00822094|Primary|Proportion of Subjects Surviving at 1 Year|The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.|Up to 1 year from randomization|Efficacy Evaluable Analysis Set - All randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
1454081|NCT00821964|Secondary|Incidence of Reduction of Serum TGF-beta Levels as Assessed by ELISA and Correlation With Th1 Adaptive Immunity and Clinical Response|Incidence of reduction of serum TGF-beta levels as assessed by ELISA and correlation with Th1 adaptive immunity and clinical response is defined as a reduction of at least 25% from baseline value to the value measured at week 13.|Baseline and at weeks 13||||Participants|||Count of Participants
1454082|NCT00821964|Secondary|Endogenous Immunity to Common Breast Tumor Antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in Peripheral Blood as Assessed by IFN-gamma and ELISPOT Assay|Peripheral blood will be obtained at baseline, after cycle 3 (end of study treatment) and at week 24 (end of study) to assess the immune response. A positive antigen-specific T cell immune response will be defined as a T cell precursor frequency more robust than 1:20,000 PBMC if the patients did not have a detectable response prior to treatment. In patients with a pre-existent immune response, the development of an immune response twice baseline will constitute augmentation.|Baseline and at weeks 13 and 24||||Participants|||Count of Participants
1454083|NCT00821964|Primary|Pathologic Response by Immunohistochemical (IHC)as Assessed by Skin Punch Biopsy of the Target Lesion|This is done by IHC staining reviewed by a pathologist. This is done by comparing the baseline to the post-treatment biopsy tissue. Yes equals absence of residual disease.|Pre-and post-treatment||||Participants|||Count of Participants
1454084|NCT00821964|Primary|Safety and Systemic Toxicity as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP)|"Evaluated according to the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 and monitoring of adverse events will be done per Food and Drug Administration (FDA) and National Cancer Institute (NCI) guidelines for the time frame below.~Number of Participants with at Least 1 Adverse Event as Assessed by a Review of Medical History, Physical Exam, Systems, Performance Status, and Clinical Labs (CBC and CMP) under the following CTCAE categories:~Constitutional (Fatigue) Neurological (Neuropathy (sensory or motor)) Cardiac (Arrhythemia) Pulmonary (Cough, Pharyngitis) GI (Constipation, Diarrhea, Mucositis, Vomiting) Dermatology (Ulceration, Hairloss/alopecia) Pain (Headache, other pain) Syndrome (Flu-like) Visual Changes Hearing/Auditory Edema Other (General)~In addition they were asked the severity of the event so that a clinician could grade the event."|Baseline and weeks 5, 9 13, 16, 20, and 24||||Participants|||Count of Participants
1454685|NCT00815659|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events in 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Number of patients with any adverse events in 3 months|||Participants|||Number
1454085|NCT00821964|Primary|Anti-tumor Effects of Imiquimod as Assessed by Modified World Health Organization (WHO) Criteria|"Tumor responses will be determined using the sum of the products of the largest perpendicular dimensions. Target lesions will be evaluated by the following response criteria: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).~Evaluation of target lesions per modified WHO response criteria:~Complete response (CR): complete clearance (100%) of target lesion(s)~Partial response (PR): ≥ 50% decrease in target lesion size~Stable disease (SD): < 50% decrease in target lesion size~Progressive (PD): ≥ 25% increase in target lesion size Overall Response Rate (ORR) determined at end of study treatment which was 1 week after cycle #3, unless patient was withdrawn from study. If patient was withdrawn from study, then ORR was determined after their last cycle of treatment received."|Baseline and then every 4 weeks until week 24||||Participants|||Count of Participants
1454086|NCT00821951|Secondary|Vorinostat Modification of the DNA Damage Response in Patient Samples||1 Year|||||||
1454087|NCT00821951|Secondary|Target Lesion Response||1 Year|||||||
1454088|NCT00821951|Primary|The Primary Endpoint of the Study is to Establish the Maximum Tolerated Dose of Vorinostat When Given Concurrently With Palliative Radiation.|maximum tolerated dose of vorinostat when given concurrently with radiation|1 Year|All participants who received any drug|||mg|||Number
1454089|NCT00821886|Secondary|Overall Survival|Defined as the time between Day 1 Cycle 1 to date of death from any cause.|approximately 48 months||||months||95% Confidence Interval|Number
1454090|NCT00821886|Secondary|Disease-free Survival|Defined as the interval from the first date of study treatment until the date of tumor recurrence or death from any cause|expected average 18 months||||months||95% Confidence Interval|Median
1454091|NCT00821886|Secondary|Number of Subjects With Adverse Events as a Measure of Safety and Toxicity|Assessment based on the frequency of treatment-related adverse events according to NCI CTCAE criteria v3.0.|Day 1 of each 3 week cycle up to 6 cycles , and every 9 weeks post-surgery until treatment discontinuation|Includes eligible patients|||participants|||Number
1454092|NCT00821886|Primary|Pathologic Complete Response (pCR)|Proportion of patients who do not exhibit residual invasive breast cancer in breast or axillary lymph nodes at time of surgery|average18 months|Patients who underwent surgery per protocol|||participants|||Number
1454093|NCT00821873|Primary|MRI to Evaluate Success of Outcome.|"The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.~The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score."|24 months||||units on a scale||Standard Deviation|Mean
1454094|NCT00821821|Secondary|mRS, NIHSS, Barthel Index||throughout study|||||||
1454095|NCT00821821|Secondary|Plasma MCI-186 Pharmacokinetics|The geometric mean values of MCI-186 plasma concentration at the end of the infusion (at 72h) in cohorts 1 and 2 were determined.|72 hours|The subjects with reliable measured values for plasma concentration were selected for pharmacokinetic analysis: 5 subjects in MCI-186 Cohort 1 and 11 subjects in MCI-186 Cohort 2.|||ng / ml||Geometric Coefficient of Variation|Geometric Mean
1454096|NCT00821821|Primary|Number of Participants That Experienced Adverse Events|Additional Outcome Measures are included in Tables for Serious Adverse Events and Other Adverse Events to report their numbers and frequency.|87days||||participants|||Number
1454097|NCT00821678|Secondary|Received at Least 8 Sessions of Exposure Based Therapy|0 - received <8 sessions of exposure based therapy; 1 - received >=8 sessions of exposure based therapy|12 months||||participants|||Number
1454098|NCT00821678|Secondary|Medication Adherence, Defined as Taking Medication <80% of Days|0 - taking medication <80% of days; 1 - taking medications >=80%|6 months||||participants|||Number
1454099|NCT00821678|Secondary|Satisfaction With Care (ECHO)||6 months||2016-12-31|12/2016||||
1454100|NCT00821678|Secondary|Change in Continuous Measure of Quality of Life (QWB)|range - 0-1 (higher score represents greater wellbeing)|6 months||2016-12-31|12/2016||||
1454101|NCT00821678|Secondary|Change in Continuous Measure of Health Status (SF12V PCS)|range - 0-100 (higher score represents greater physical health status)|6 months||||units on a scale||Standard Deviation|Mean
1454102|NCT00821678|Secondary|Change in Continuous Measure of Alcohol Use (Audit Score)|range - 0-12 (higher score represents greater severity)|6 months||||units on a scale||Standard Deviation|Mean
1454103|NCT00821678|Secondary|Change in Continuous Measure of Depression Symptom Severity (SCL-20)|range - 0-4 (higher score represents greater severity|6 months||||units on a scale||Standard Deviation|Mean
1454104|NCT00821678|Primary|Change in PTSD Symptom Severity (PDS)|range - 0-51 (higher score represents greater severity)|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
1454105|NCT00821587|Primary|Hepatitis C Viral Level|Undetectable or <100 COPIES/ML|6 months after completion of interferon based therapy|Randomization was performed using computer-generated random numbers. 150 patients were eligible and 39 met entry criteria for enrollment in the study. Subjects with HCV recurrence (Ishak Stage2) were randomized to TAC or to change to CsA before initiation of therapy with PEGa-2a and ribavirin for 48 weeks for genotype-1,or 24 weeks for genotype-3.|||Participants|||Number
1454106|NCT00821509|Primary|Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI). Individual weekly reports were combined in a single continuum and successive days with either RTI or GTI symptoms were designated as disease episodes due. Numbers of RTI, GTI and either episodes in each trial arm were calculated, and for the respective proportion, were divided by the total number of weekly reports collected in the arm.|At the end of the study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants|||Disease episodes|Participants||Number
1454145|NCT00820534|Secondary|Size of the Cold Sore|The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.|72 hours||||square mm||95% Confidence Interval|Mean
1454107|NCT00821509|Primary|Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm|Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI) as well as whether they were working (if expected) or not, daily for the previous calendar week. Individual weekly reports were combined in a single continuum and successive days with both symptoms and absence from work were designated as days-off episodes due to own infectious disease. Number of these episodes in each trial arm was calculated and for the respective proportion, was divided by the total number of weekly reports collected in the arm.|At the end of the entire study period (16 months)|Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants|||sick-leave episodes|Participants||Number
1454108|NCT00821431|Secondary|Healing Measured by Number of Subjects Healed During the 12 Week Study Period||12 weeks||||Number of subjects healed|||Number
1454109|NCT00821431|Primary|Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)||12 Weeks||||Number of Subjects with Adverse Events|||Number
1454110|NCT00821327|Secondary|Ovarall Survival (OS)|OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.|2 years|ITT population|||months||95% Confidence Interval|Median
1454111|NCT00821327|Secondary|Progression-free Survival|"PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.~Progression (PD) is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions."|2 years|ITT population|||Month||Full Range|Median
1454112|NCT00821327|Primary|Objective Response Rate (ORR, CR+PR) in Patients With Advanced/Metastatic UC Treated With the Combination of Gemcitabine, Cisplatin, and Sunitinib.|Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|2 years|All eligible patients who meet the protocol-specified efficacy analyses requirements and who have received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1454113|NCT00821236|Primary|1 Month Postoperative Lasik Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Month Postoperative||||LogMar||Standard Deviation|Mean
1454114|NCT00821236|Primary|1 Week Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured withouth glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 week post op||||LogMar||Standard Deviation|Mean
1454115|NCT00821236|Primary|1 Day Postoperative Lasik Uncorrected Visual Acuity|Visual acuity measured without glasses or contact lenses. LogMar is a method of measuring visual acuity. Generally speaking, the U.S. population is familiar with 20/20 visual acuity reference. Samples of LogMar equivalent values would be 20/20=0.0 LogMar, 20/25=0.1 LogMar, 20/16=-0.1, etc.|1 Day||||LogMar||Standard Deviation|Mean
1454116|NCT00821184|Secondary|Improvement of Symptom Severity||3 months|data were not collected||||||
1454117|NCT00821184|Primary|Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.||0 week - 12 weeks||||incontinence episodes per 24 hours||Full Range|Mean
1454118|NCT00821119|Secondary|Bronchopulmonary Dysplasia|The incidence of bronchopulmonary dysplasia was calculated based on the number of infants surviving to 36 weeks postmenstrual age and diagnosed with bronchopulmonary dysplasia, according to the definiton of bronchopulmonary dysplasia currently used in the neonatal Unit.|at 36 weeks gestational age|The number of preterm infants surviving to 36 weeks postmenstrual age were eligible for analysis|||participants|||Number
1454119|NCT00821119|Primary|Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP)|The primary outcome of the study was the need for intubation within the first 72 hours (h) of life.The need for intubation was made by the attending neonatologist, according to the strict protocol of intubation for ventilation, used in the neonatal Unit|first 3 days of life(72hours)|We estimated a 20% absolute reduction in the need of using endotraqueal ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.|||participants|||Number
1454120|NCT00821119|Primary|Need for Endotracheal Ventilation in the First 72 hs of Life|number of participants that needed endotracheal ventilation (failed non invasive ventilation) in the first 72 hours of life|first 72 hs of life|40 - 45% of our previous preterm infants on NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.|||participants|||Number
1454121|NCT00821093|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1454146|NCT00820534|Primary|Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.|Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).|72 hours||||participants|||Number
1454122|NCT00821093|Primary|Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)|Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1454123|NCT00821041|Secondary|Beliefs and Attitudes About Sleep||6 weeks|||||||
1454124|NCT00821041|Secondary|Pre-Sleep Arousal|Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.|6 weeks||||PSA Scale||Standard Deviation|Mean
1454125|NCT00821041|Primary|Sleep Quality|Sleep Quality was assessed by taking the average of two items: “How well do you feel this morning?” And “How enjoyable was your sleep last night?” (0 = not at all, 4 = very).|6 weeks||||0-4 scale of sleep quality||Standard Deviation|Mean
1454126|NCT00820898|Primary|Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0||Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||Participants|||Count of Participants
1454127|NCT00820898|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
1454128|NCT00820872|Primary|Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0||Up to 10 years|All evaulable patients|||percentage of patients|||Number
1454129|NCT00820755|Primary|Percentage of Participants With 1-year Overall Survival|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier. Percentage of participants who were still alive until one year after the last participant was included (March 2010).|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until one year after the last participant was included (March 2010)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
1454130|NCT00820755|Secondary|Percentage of Participants With Disease Control for the Whole Study Period|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed best overall response according to IRC assessment in combination therapy phase and radiological assessments (based on RECIST Version 1.0 criteria) in the maintenance therapy phase.|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
1454131|NCT00820755|Secondary|Percentage of Participants With Disease Control in the Combination Therapy Phase|The disease control rate is defined as the percentage of participants having achieved complete response or partial response or stable disease as the unconfirmed BOR according to IRC assessment.|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
1454132|NCT00820755|Secondary|Percentage of Participant With Best Unconfirmed Tumor Response for the Whole Study Period|The response rate is defined as the percentage of participants having achieved CR and PR as the BOR according to IRC assessment in combination therapy phase and radiological assessments (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) in the maintenance therapy phase. As per RECIST v1.0 for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy and 6-weekly during maintenance therapy period until progression and at end of both periods, reported between day of first participant included, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
1454192|NCT00819741|Secondary|ECG (ElectroCardioGram)|The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
1454133|NCT00820755|Secondary|Percentage of Participants With Best Unconfirmed Tumor Response in the Combination Therapy Phase|The response rate is defined as the percentage of participants having achieved complete response (CR) or partial response (PR) as the unconfirmed best overall response (BOR) according to centrally reviewed investigator assessments based on an independent review charter (IRC). As per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: CR = Disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Evaluations were performed every 2 cycles during combination therapy period until progression and at the end of combination therapy period, reported between day of first participant included, that is, Jan 2009, until cut-off date, (17 Dec 2011)|ITT analysis set included all participants enrolled in this study.|||percentage of participants||95% Confidence Interval|Number
1454134|NCT00820755|Secondary|Time to Treatment Failure (From Randomization to Cetuximab Maintenance Regimen Until Death)|Time from randomization in cetuximab maintenance regimen to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of randomization (Day 1 of maintenance therapy) if they received no study drug.|Time from randomization in cetuximab maintenance regimen to treatment failure or last drug intake, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
1454135|NCT00820755|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from trial inclusion to date of either first occurrence of progression, discontinuation of treatment due to progression or adverse event, withdrawal of consent or lost to follow up, start of further anticancer therapy, or death, whichever is earlier. Participants without events are censored either at the time of their last drug intake, or on the day of inclusion (Day 1) if they received no study drug.|Time from trial inclusion to treatment failure or last drug intake, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
1454136|NCT00820755|Secondary|Overall Survival (OS) Time (From Randomization to Cetuximab Maintenance Regimen Until Death)|The OS time is defined as the time from randomization in cetuximab maintenance regimen to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization in cetuximab maintenance regimen to death or last day known to be alive, reported between day of first participant randomized, that is, May 2009 until cut-off date (17 Dec 2011)|ITT maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on CT or MRI scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
1454137|NCT00820755|Primary|Overall Survival (OS) Time|The OS time is defined as the time from trial inclusion to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from trial inclusion to death or last day known to be alive, reported between day of first participant included, that is, Jan 2009 until cut-off date (17 Dec 2011)|Intention-to-treat (ITT) maintenance analysis set included all participants who were included in ITT (all the participants enrolled in this study) analysis set, judged to be progression-free (based on computer tomography [CT] or magnetic resonance imaging [MRI] scan) by the Investigator and randomized to maintenance therapy.|||months||95% Confidence Interval|Median
1454138|NCT00820664|Secondary|Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo.||4 weeks|||||||
1454139|NCT00820664|Primary|Immunohistochemistry (IHC) Proliferative Effects Measurement|Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.|4 weeks|Though 29 subjects were enrolled, only 20 subjects had biopsy samples that were deemed adequate for Ki-67 immunohistochemical analysis at Week 4.|||Square root of % positive stained cells||95% Confidence Interval|Least Squares Mean
1454140|NCT00820612|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.|5 days|100% completed follow-up|||participants|||Number
1454141|NCT00820573|Secondary|Changes in Plasma Glucose Post-MTT After Each Six Weeks of Therapy Compared to Baseline|The absolute values of mean plasma glucose post-meal (360 minutes)were determined after each specific 6 week treatment and these absolute values after each specific sequence therapy were compared amongst all groups.|360 min|power calculation based on previous data|||mg/dl||Standard Error|Mean
1454142|NCT00820573|Primary|Average of Plasma Glucose During Mixed Meal Tolerance Test (MTT) Compared to Baseline Plasma Glucose to Post Therapy (6-weeks).|The degree of suppression of baseline endogenous glucose production was measured in absolute values and as a percent of basal values at the end of each 6-week therapeutic period. The absolute values obtained in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|power calculations with data from previous similar studies|||mg/kg.min||Standard Error|Mean
1454143|NCT00820573|Secondary|Fasting Plasma Glucose 6 Weeks After Therapy|Basal pasma glucose was determined with the glucose oxidase method after each specific 6 week treatment. The absolute values obtained of basal plasma glucose at the end of each 6-week therapeutic period in each sequence study group (both basal and post-meal) were compared amongst all groups.|6 weeks|All 16 participants were analyzed using ANOVA to compare results after each 6 week period of exposure to therapeutic agent(s)|||mg/dl||Standard Error|Mean
1454147|NCT00820443|Secondary|Metal Ion Analysis; Unilateral Only; Serum Chromium|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.|||ug/L||Standard Deviation|Mean
1454148|NCT00820443|Secondary|Metal Ion Analysis (Unilateral Only):Serum Cobalt|Serum cobalt and chromium are recommended as the optimal tests for evaluation of joint implant wear, patients with CoM implants have elevated serum chromium and cobalt concentrations. Clinically important implant wear is indicated when serum chromium exceeds 15 ng/mL and cobalt exceeds 10 ng/mL; these symptomatic patients are likely to have significant implant deterioration. serum cobalt and chromium are highest in the first year after implant. In subsequent years, and after run-in wear (initial wear of a hip implant that produces the greatest amount of metal ion release), cobalt and chromium concentrations decline, then reach steady state around 3 years after implant.|24 months|Only Unilateral participants were collected the Metal Ion data, and due to missing values/assessments/data, not all of the unilateral participants had Metal Ion data at 24 months, only 44 of them were evaluated.|||ug/L||Standard Deviation|Mean
1454149|NCT00820443|Secondary|WOMAC Raw Total Score|The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints The WOMAC measures five items for pain (score range 0–20), two for stiffness (score range 0–8), and 17 for functional limitation (score range 0–68). Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations (range is 0-96).|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 175 participants were evaluated at 24 months.|||units on a scale||Standard Deviation|Mean
1454150|NCT00820443|Secondary|The Secondary Measures of the UCLA Functional Assessments|"UCLA: University of California LosAngeles Activity Score~UCLA score is a validated scoring system for hip replacement outcome, The single item UCLA scale asks patients to rate their activity level from 1 to 10, with 1 defined as “no physical activity” and 10 defined as “regular participation in impact sports”. The score is the higher the better."|24 months|Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 177 participants were evaluated at 24 months.|||units on a scale (10 points)||Standard Deviation|Mean
1454151|NCT00820443|Primary|Primary Endpoint/Measures: Success at 24 Months|"The patient success definition is measured at the 24 month interval by the following:~Harris Hip Score (HHS) of > 80 • < 2mm radiolucency (width) in any Gruen (stem) or DeLee/Charnley (cup) zone and no more than mild pain.~No revision or removal of any part of the device for aseptic reasons prior to or on day 730 following the index surgical procedure.~A patient must meet all three criteria in the definition to be considered a success. A patient who does not meet all three criteria will be deemed a failure.~The Harris hip score, is used to measure the outcome of total hip arthroplasty. Eight sections on the HIP are rated by the patient: pain, distance walked, activities, public transportation, support, limp, stairs and sitting. Total scores are out of 100 and grouped as follows: 90 - 100 Excellent,80 - 90 Good,70 - 79 Fair,60 - 69 Poor.< 60 Failed.Any score above 60 is acceptable, although the higher the score, the better the patient's overall adjustment after the surgery"|24 Month|Patients with Harris Hip Score (HHS) of > 80 Because there isn't complete radiographic data,the composite primary outcome is not analyzed at 24 month as in protocol. Only the number of patients who has HHS score greater that 80 is entered.Due to missing values/assessments/data, not all of the participants were evaluated at 24 months, only 197.|||participants|||Number
1454152|NCT00820248|Secondary|Overall Survival Rate|"Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive.~Number of death and alive patients will be reported."|6.2 years||||Participants|||Count of Participants
1454153|NCT00820248|Primary|Progression-free Survival (PFS) Rate|"The progression event is defined by first event of the following,~Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason~Number of patients with and without progression event will be reported."|6.2 years||||Participants|||Count of Participants
1454154|NCT00820222|Secondary|Number of Participants Expressing Glucocorticoid Receptor, Phosphatase and Tensin Homolog (PTEN), Phosphatidylinositide 3-kinase (PI3K)/AKT, Protein 53 (P53), Insulin-like Growth Factor-1 (IGF-1), and Genes Involved in Cell Cycle Regulation|Because the study terminated early, pharmacogenetic and biomarker analyses were not performed.|Baseline|ITT Population||||||
1454155|NCT00820222|Secondary|Number of Participants With Qualitative and Quantitative Toxicities|"Qualitative and quantitative toxicities were measured as AEs. See the outcome measure entitled Number of participants with the indicated Grade 3 or Grade 4 Adverse Events (AEs) occurring in >=2 participants in either treatment arm and the AE module of this results summary for a list of AEs occurring in the study. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment."|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)|Safety Population||||||
1454686|NCT00815659|Secondary|Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Small HDL subfraction levels of participants|||mg/mL||Standard Deviation|Mean
1454156|NCT00820222|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs) Occurring in >=2 Participants in Either Treatment Arm|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was related to study drug. AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0=No AE or within normal limits; 1=Mild AE; 2=Moderate AE; 3=Severe and undesirable AE; 4=Life-threatening or disabling AE; 5=Death related to AE.|From the first dose of study medication until 30 days after the last dose of study treatment (average of 10 months)|Safety Population: all participants in the ITT Population who received at least one dose of investigational product, based on the actual treatment received if this differed from that to which the participant was randomized|||participants|||Number
1454157|NCT00820222|Secondary|Number of Participants With CNS Progression at Any Time|CNS progression was documented by a brain scan and was indicated by the investigator on the follow-up electronic Case Report Form. CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease, with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From the time of randomization until death due to any cause (average of 10 months)|M-ITT Population|||participants|||Number
1454158|NCT00820222|Secondary|Duration of Response|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) until the first documented sign of PD (at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions) or death due to breast cancer. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 10 months)|ITT Population. Only those participants with CR or PR showing PD or death due to breast cancer were analyzed.|||months||95% Confidence Interval|Median
1454159|NCT00820222|Secondary|Number of Participants With Clinical Benefit (CB)|CB is defined as the number of participants with evidence of confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD [defined as at least a 20% increase in the sum of the LD of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions] based on investigator assessment), for at least 24 weeks.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.|||participants|||Number
1454160|NCT00820222|Secondary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants with either a confirmed complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of the LD of the target lesions, compared with the baseline sum LD). CR and PR were assessed per Response Evaluation Criteria in Solid Tumors (RECIST). To be assigned a status of PR or CR, a confirmatory disease assessment was to be performed 28 days (4 weeks) or greater after the criteria for response were first met. In addition, a bone scan must have been obtained to rule out the presence of new bone lesions or progression of existing bone lesions, even if the participant had no bone lesions present at Baseline. If a bone scan was performed at the time of initial response or near the time of response, the bone scan did not need to be repeated.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|ITT Population. Only those participants enrolled under protocol amendment 3 were required to have PR or CR confirmation. Those participants enrolled under protocol amendments 1 and 2 were considered to have a “confirmed” response at the time of the first PR or CR regardless of follow-up scans.|||participants|||Number
1454161|NCT00820222|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause or to the date of censor. In the absence of confirmation of death, survival time was to be censored at the time of the last investigator contact.|From randomization until death due to any cause (average of 10 months)|ITT Population|||months||95% Confidence Interval|Median
1454162|NCT00820222|Secondary|Time to First CNS Progression, Defined as the Time From Randomization Until the Date of Documented CNS Progression as the First Site of Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 mm on T1W MRI without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until the date of documented CNS progression (average of 10 months)|M-ITT Population. Only those participants who had no Baseline CNS metastases and who had CNS progression by radiographic confirmation (per Response Evaluation Criteria in Solid Tumors, 1.0: a 20% increase in the sum of the longest diameter [LD] of target lesions or the appearance of >=1 new lesions) were included in this analysis.|||months||Standard Deviation|Mean
1454163|NCT00820222|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), or death due to any cause. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared with the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions based on investigator assessment of both CNS and non-CNS for response.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered|||months||95% Confidence Interval|Median
1454164|NCT00820222|Primary|Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse|CNS relapse is defined as the appearance of >=1 enhancing lesion measuring >=6 millimeters (mm) on T1Weighted (T1W) Magnetic Resonance Imaging (MRI) without CNS symptoms that were considered to be unequivocal based on all relevant radiological features (e.g., associated T2W signal abnormality); the appearance of any enhancing lesion on T1W MRI with CNS symptoms; unequivocal finding of leptomeningeal disease (defined as the dissemination of cancer throughout the spinal fluid), with or without symptoms; and unequivocal finding of multifocal intraparenchymal lesions with or without symptoms. In the event of the appearance of a <6 mm lesions(s) without CNS lesions, or equivocal findings potentially suggesting leptomeningeal disease, these findings were followed with a subsequent scan within 6 weeks. If unequivocal progression was determined with the subsequent scan and/or CNS symptoms occurred, then CNS relapse crieria were met.|From randomization until disease progression, death, or discontinuation from the study (average of 10 months)|Modified Intent-to-Treat (M-ITT) Population: all participants who were randomized to study treatment regardless of whether or not treatment was administered and who had no Baseline CNS metastases per Independent Review Committee (IRC) assessment|||participants|||Number
1454165|NCT00819910|Secondary|Mean Levels of Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Initial Visit and Final Visit|The mean Levels of AST and ALT measured at initial visit (Day 0) and final visit (Week 12) annotated as AST 1, AST 12, and ALT 1 and ALT 12, respectively.|12 weeks from initial visit (day 0) to final visit (12 weeks)||||mg/dl||Standard Deviation|Mean
1454166|NCT00819910|Secondary|Post-treatment Percent Change in Apolipoprotein A-I (Apo AI), Apolipoprotein A-II (Apo AII) and Apolipoprotein C-III (Apo CIII) Levels|Post-treatment median change in Apo AI, Apo AII and Apo CIII levels reported in mg/dL with Interquartile ranges provided|12 weeks from initial visit (day 0) to final visit (12 weeks)||||% Change||Inter-Quartile Range|Median
1454167|NCT00819910|Secondary|Post-treatment Percent Change in Low-Density Lipoprotein (LDL) Levels|The reported percent change is the difference between LDL levels obtained on initial visit (day 0) and LDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)||||% change||Standard Deviation|Mean
1454168|NCT00819910|Secondary|Post-treatment Percent Change in High-Density Lipoprotein (HDL) Levels|The reported percent change is the difference between HDL levels obtained on initial visit (day 0) and HDL levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)||||% change||Standard Deviation|Mean
1454169|NCT00819910|Primary|Percent Change in Triglyceride (TG) Levels Post Treatment|The reported percent change is the difference between TG levels obtained on initial visit (day 0) and TG levels obtained at final visit (week 12) as per protocol|12 weeks from initial visit (day 0) to final visit (12 weeks)|Mean percent change post treatment ( unit %). TG was measured using mg/dL units|||% change||Standard Deviation|Mean
1454170|NCT00819832|Primary|Phase 2: Change in CTCB From Baseline to Post-treatment||CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)|||||||
1454171|NCT00819832|Primary|Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)|Increase in number of cancer cells in patient’s blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).|Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)|Study terminated by sponsor; No data analysis done on limited amount of data gathered.||||||
1454172|NCT00819780|Secondary|Number of Participants With Adverse Events (AEs)|Severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0, with the exception of some dermatology/skin adverse events that were graded using CTCAE v3.0 with modifications. Fatal adverse events are classified as grade 5. Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs were those that the investigator considered a reasonable possibility that might have been caused by study drug.|The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 8.0 months for Panitumumab Plus mFOLFOX arm and 7.3 months for Bevacizumab Plus mFOLFOX6 arm.|Safety analysis set, which included all randomized participants who received at least 1 dose of protocol treatment (ie, panitumumab, bevacizumab, or any component of mFOLFOX6).|||participants|||Number
1454173|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS / BRAF|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS/BRAF Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.|||percentage of participants||95% Confidence Interval|Number
1454174|NCT00819780|Secondary|Percentage of Participants With an Objective Response for Participants With Wild-type RAS|"Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.~Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions."|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Investigator Tumor Response Analysis Set, defined as the subset of participants in the Wild-type RAS Efficacy Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.|||percentage of participants||95% Confidence Interval|Number
1454175|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS / BRAF|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.|||months||95% Confidence Interval|Median
1454176|NCT00819780|Secondary|Overall Survival in Participants With Wild-type RAS|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.|||months||95% Confidence Interval|Median
1454177|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type RAS / V-raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS/BRAF Efficacy Analysis Set was defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set with wild-type KRAS exon 2, 3, and 4, NRAS exon 2, 3, 4, and BRAF exon 15.|||months||95% Confidence Interval|Median
1454178|NCT00819780|Secondary|Progression-free Survival (PFS) in Participants With Wild-type Rat Sarcoma Viral Oncogene Homolog (RAS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Wild-type RAS Efficacy Analysis Set, defined as a subset of Wild-type KRAS Exon 2 Efficacy Analysis Set including all randomized participants with wild-type KRAS exon 2, 3, 4, NRAS exon 2, 3, and 4.|||months||95% Confidence Interval|Median
1454179|NCT00819780|Secondary|Resection Rate|The resection rate was defined as the percentage of participants with a surgical procedure that resulted in partial reduction or complete eradication of all metastatic disease.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set|||percentage of participants||95% Confidence Interval|Number
1454180|NCT00819780|Secondary|Time to Initial Objective Response|For participants with a confirmed objective response, the time from randomization to the date of first confirmed objective response. Assessments are based on the investigator’s review of scans using a modified-RECIST v1.0. An objective response is defined as a best tumor response of complete or partial response. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders|||months||Inter-Quartile Range|Median
1454181|NCT00819780|Secondary|Time to Disease Progression|Time to progression (TTP) is defined as the time from randomization to the date of radiologic disease progression per modified RECIST 1.0 criteria. Participants not meeting criteria for disease progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set|||months||95% Confidence Interval|Median
1454182|NCT00819780|Secondary|Duration of Response|For participants with a confirmed objective response, the time from first confirmed objective response to radiologic disease progression per modified RECIST 1.0 criteria or death. For participants who responded and have not progressed or died, duration of response was censored at their last evaluable disease assessment date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set: Responders|||months||95% Confidence Interval|Median
1454193|NCT00819741|Secondary|Physical Examinations|The number of subjects having a physical examination event that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. Physical examination included cardiovascular system, respiratory system, musculoskeletal system, nervous system and abdomen.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
1454183|NCT00819780|Secondary|Percentage of Participants With an Objective Response|Objective response was defined as having a confirmed complete response (CR) or partial response (PR) during first-line treatment, based on the investigator’s review of scans using a modified-RECIST v1.0. A complete or partial response was confirmed no less than 4-weeks after the criteria for response were first met. Complete Response: Disappearance of all target and non-target lesions and no new lesions. Partial Response: At least a 30% decrease in the sum of the longest diameter (SLD) of target lesions and no progression of non-target lesions and no new lesions, or the disappearance of all target lesions with persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease and no new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Evaluable for Local Tumor Response Analysis Set, defined as the subset of participants in the ITT Analysis Set who had at least 1 unidimensionally measurable lesion per modified RECIST 1.0 per the local investigator.|||percentage of participants||95% Confidence Interval|Number
1454184|NCT00819780|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death, with participants alive or lost to follow-up at the analysis data cutoff date censored at their last contact date.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat analysis set|||months||95% Confidence Interval|Median
1454185|NCT00819780|Primary|Progression-free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first disease progression, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever was later). Participants not meeting the criteria by the cutoff date were censored at the last evaluable tumor assessment date. Tumor response was evaluated by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 every 8 weeks until radiographic disease progression. Progression is defined as at least a 20% increase in the size of target lesions, unequivocal progression of existing non-target lesions, or any new lesions.|From randomization until the data cutoff date of 30 May 2012; median follow-up time was 60 weeks.|Intent-to-treat (ITT) analysis set (all randomized participants)|||months||95% Confidence Interval|Median
1454186|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Week 8 (End of Active Treatment) to 24-hours After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. The SBP at rest vs peak HR was recorded at Week 8 (end of active treatment) and Week 8 + 2 days (48-hrs after last dose; 24-hrs after missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Week 8 (Last dose; end of active treatment) and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.|||mmHg||Standard Error|Least Squares Mean
1454187|NCT00819767|Secondary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8|The difference in resting vs. peak (85% of the maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 (end of active treatment); the change in SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 (end of active treatment). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug.|||mmHg||Standard Error|Least Squares Mean
1454188|NCT00819767|Primary|Change in Resting vs. Peak Heart Rate Systolic Blood Pressure (SBP) From Baseline to Week 8 After a Missed Dose|The difference in resting vs. peak (85% of maximal predicted) heart rate (HR) SBP was calculated by measuring SBP before and during exercise on a standardized treadmill test, conducted according to the Bruce Protocol. Treadmill speed and incline were increased every 3 minutes until the patient was exhausted or peak HR was reached. The SBP at rest vs peak HR was recorded at Baseline and at Week 8 + 2 days (24-hrs after a missed dose); the change in rest vs. peak SBP between these timepoints is reported. The analysis included the rest to peak increase in SBP at baseline as a covariate.|Baseline and Week 8 + 2 days (48-hours after the last dose; 24 hours after a missed dose). Blood Pressure measurements were taken at rest and at peak heart rate at both timepoints.|The Full Analysis Set (FAS) consisted of all patients who were randomized and took at least one dose of study drug. The Exercise Evaluable Set (EES) included all patients included in the FAS for whom the treadmill test values for SBP at peak were available at baseline and after a missed dose.|||mmHg||Standard Error|Least Squares Mean
1454189|NCT00819741|Secondary|Haematology: Haemoglobin|Haemoglobin was measured. The number of subjects having a change in Haemoglobin measurement from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant' 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
1454190|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ASAT)|The number of subjects having a change in Aspartate Aminotransferase (ASAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
1454191|NCT00819741|Secondary|Biochemistry: Alanine Aminotransferase (ALAT)|The number of subjects having a change in Alanine Aminotransferase (ALAT) from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.|Week -2, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||Subjects|||Number
1454194|NCT00819741|Secondary|Change in Blood Pressure|Calculated as the mean change in diastolic and systolic blood pressure after 16 weeks of treatment|Week 0, week 16|Safety analysis set was defined as all randomised and exposed subjects.|||mmHg||Standard Deviation|Mean
1454195|NCT00819741|Secondary|Hypoglycaemic Episodes|Number of hypoglycaemic episodes from Week 0 to Week 16, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-16|Safety analysis set was defined as all randomised and exposed subjects.|||episodes|||Number
1454196|NCT00819741|Secondary|Change in 2-hour Postprandial Serum C-peptide|Calculated as an estimate of the mean change in 2-hour postprandial serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||ng/ml||Standard Error|Least Squares Mean
1454197|NCT00819741|Secondary|Change in Fasting Serum C-peptide|Calculated as an estimate of the mean change in fasting serum C-peptide after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||ng/ml||Standard Error|Least Squares Mean
1454198|NCT00819741|Secondary|Change in 2-hour Postprandial Serum Insulin|Calculated as an estimate of the mean change in 2-hour postprandial serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||mU/L||Standard Error|Least Squares Mean
1454199|NCT00819741|Secondary|Change in Fasting Serum Insulin|Calculated as an estimate of the mean change in fasting serum insulin after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product. A total of 100 subjects (50 per study group) out of the total subjects were randomly selected in the trial. Four trial sites were selected for the subgroup study.|||mU/L||Standard Error|Least Squares Mean
1454200|NCT00819741|Secondary|Change in 7-point Plasma Glucose Profile|Calculated as an estimate of the mean change in 7-point (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime) plasma glucose profile after 16 weeks of treatment.|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
1454201|NCT00819741|Secondary|Change in 2-hour Postprandial Plasma Glucose|Calculated as an estimate of the mean change in 2-hour postprandial plasma glucose following a standard test meal after 16 weeks of treatment|Week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
1454202|NCT00819741|Secondary|Change in Fasting Plasma Glucose|Calculated as an estimate of the mean change in fasting plasma glucose after 16 weeks of treatment.|week 0, week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||mmol/L||Standard Error|Least Squares Mean
1454203|NCT00819741|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c)|Calculated as an estimate of the mean change in HbA1c after 16 weeks of treatment.|week -2 (screening), week 16|Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.|||percentage (%) of total haemoglobin||Standard Error|Least Squares Mean
1454204|NCT00819637|Secondary|Pharmacokinetics of Arformoterol in This Clinical Setting||5 hours|||||||
1454205|NCT00819637|Secondary|All of the Primary and Secondary Endpoints Partitioned by the Presenting PFT in Quartiles and the Presenting S Albuterol Levels in Quartiles||5 hours|||||||
1454206|NCT00819637|Secondary|Percent of Patients in Each Group Requiring Additional Therapies After the First Hour of Study Drug Treatments|2 subjects were enrolled. Neither required additional asthma treatment after the 1st hour of study drug teatments.|5 hours|||||||
1454207|NCT00819637|Secondary|Percent of Responders (Defined as Those Discharged Following Treatment Who Did Not Require Additional Therapy in the ED)|The 2 subjects enrolled were both discharged home after study protocol completion, with no further treatment required in the ED setting.|5 hours|||||||
1454208|NCT00819637|Secondary|The Time Required to Achieve a FEV1 and PEFR > 60% Predicted for Each Dose (Individual and Cumulative)||5 hours|||||||
1454209|NCT00819637|Secondary|The Time to Onset of a 15% Improvement in FEV1 for Each Dose (Individual and Cumulative) and Total Dose of Study Medication to Reach This||5 hour|||||||
1454210|NCT00819637|Secondary|The Peak Change (Liters) and Peak Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour|||||||
1454211|NCT00819637|Secondary|The Mean Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour|||||||
1454212|NCT00819637|Secondary|The Mean Percent Change From Baseline in the FEV1 and PEFR (Absolute and Percent Predicted) Following Each Dose of Study Drug||1 hour|||||||
1454213|NCT00819637|Primary|The Averaged Mean Percent Change From Baseline FEV1 and PEFR (Percent Predicted and Absolute) After the 3 Doses of Study Drug||1 hour|As the study was terminated with 2 subjects enrolled, those 2 subjects were used for the limited statistical analysis.|||percent change||95% Confidence Interval|Median
1454214|NCT00819637|Secondary|Number of Participants Treated With Arformoteral in Acute Asthma Exacerbation as a Measure of Safety and Tolerability.||5 hours|||||||
1454215|NCT00819637|Secondary|Most Effective Dose of Inhalation Arformoterol for Treating Acute Bronchospasm in Asthmatics by Evaluating the Averaged Mean Percent Change From Baseline % Predicted FEV1 After 3 Doses of Study Medication in Each of the 3 Groups||1 hour|||||||
1454216|NCT00819585|Secondary|Extension Study: Amount of Rescue Medication Taken|The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||mg||Standard Deviation|Mean
1454217|NCT00819585|Secondary|Extension Study: Physician’s Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare|Tenderness was rated on a 0-3 point scale: 0=“no pain”, 1=patient states that “there is pain”, 2=patient states “there is pain and winces”, and 3=patient states “there is pain, winces and withdraws” on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=“no swelling”, 1=“palpable”, 2=“visible”, and 3=bulging beyond the joint margins”. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Participants|||Number
1454218|NCT00819585|Secondary|Extension Study: Physician’s Global Assessment of Response to Treatment on a 5-point Likert Scale|The study physician made a global assessment of the participant’s response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category ‘Not assessed’ includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Participants|||Number
1454219|NCT00819585|Secondary|Extension Study: Participant’s Global Assessment of Response to Treatment on a 5-point Likert Scale|Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.|Baseline of the extension study until the end of the study (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Participants|||Number
1454220|NCT00819585|Secondary|Extension Study: Participant’s Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare|Participant’s rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose|Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)|Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.|||Units on a scale||Standard Deviation|Mean
1454221|NCT00819585|Secondary|Core Study: Physician’s Global Assessment of Response to Therapy on a 5-point Likert Scale|The study physician made a global assessment of the participant’s response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category ‘Not assessed’ includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.|Days 15, 29, 57, 85, 113, and 141 of the core study|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Participants|||Number
1454222|NCT00819585|Primary|Core Study: Mean Number of Gout Flares Per Participant|A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Gout flares||Standard Deviation|Mean
1454223|NCT00819585|Secondary|Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares|Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
1454224|NCT00819585|Secondary|Core Study: Participant’s Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares|Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Units on a scale||Standard Deviation|Mean
1454225|NCT00819585|Secondary|Core Study: Percentage of Participants With Gout Flare at Different Time Points|A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.|Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Percentage of participants||95% Confidence Interval|Number
1454226|NCT00819585|Secondary|Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization|The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.|Baseline of the core study to Week 16|Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.|||Percentage of participants|||Number
1454249|NCT00819390|Secondary|Percent CD8 CD38+ at Baseline|Baseline CD8 CD38+ is computed as the mean of pre-entry and entry CD8 CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
1454227|NCT00819585|Secondary|Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab||up to 16 weeks after randomization|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||gout flares per patient||Standard Error|Least Squares Mean
1454228|NCT00819507|Secondary|Change in Transepidermal Water Loss|A measure of water flux out the skin using a small non-invasive probe. Values can range between 0-no water loss and over 100-severe water loss. This measure indicates the degree of skin barrier permeability with lower values indicating lower permeability (improved skin barrier function).|2 weeks||||G/m^2/hr||Standard Deviation|Mean
1454229|NCT00819507|Primary|Change in Eczema Severity and Area Index|The eczema area and severity index (EAS I) is a validated composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and end of study (baseline EASI subtracted from end of study EASI) was calculated as a final outcome data point.|2 Weeks||||units||Standard Deviation|Mean
1454230|NCT00819403|Secondary|Biomarkers of Inflammation||6 weeks||||mg/dl||Standard Deviation|Mean
1454231|NCT00819403|Primary|Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression|Measured using whole blood flow cytometry|6 weeks|Based on power calculations|||ng/dl||Standard Deviation|Mean
1454232|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 24|Results reported are the week 24 percent activation levels of pDC and mDC.|At week 24|Analysis is based on all participants with assay data at week 24.|||percentage of cells||Inter-Quartile Range|Median
1454233|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Week 12|Results reported are the week 12 percent activation levels of pDC and mDC.|At week 12|Analysis is based on all participants with assay data at week 12.|||percentage of cells||Inter-Quartile Range|Median
1454234|NCT00819390|Secondary|Percent Activation Levels of Plasmacytoid Dendritic Cells (pDC) and Myeloid Dendritic Cells (mDC) at Baseline|Baseline percent activation levels of pDC were computed as the mean of pre-entry and entry percent activation levels of pDC. Similarly, baseline percent activation levels of mDC were computed as the mean of pre-entry and entry percent activation levels of mDC.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||percentage of cells||Inter-Quartile Range|Median
1454235|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 24|Results reported are the week 24 fasting LPS.|At week 24|Analysis is based on all participants with assay data at week 24.|||pg/mL||Inter-Quartile Range|Median
1454236|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Week 12|Results reported are the week 12 fasting LPS.|At week 12|Analysis is based on all participants with assay data at week 12.|||pg/mL||Inter-Quartile Range|Median
1454237|NCT00819390|Secondary|Fasting Lipopolysaccharides (LPS) at Entry|Results reported are for entry fasting LPS.|At entry|Analysis is based on all participants with assay data at entry.|||pg/mL||Inter-Quartile Range|Median
1454238|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 24|Results reported are the week 24 sCD14.|At week 24|Analysis is based on all participants with assay data at week 24.|||million pg/mL||Inter-Quartile Range|Median
1454239|NCT00819390|Secondary|Soluble CD14 (sCD14) at Week 12|Results reported are the week 12 sCD14.|At week 12|Analysis is based on all participants with assay data at week 12.|||million pg/mL||Inter-Quartile Range|Median
1454240|NCT00819390|Secondary|Soluble CD14 (sCD14) at Baseline|Baseline sCD14 was computed as the mean of pre-entry and entry sCD14.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||million pg/mL||Inter-Quartile Range|Median
1454241|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 24|Results reported are the week 24 IL-6, sTNF-rI and D-dimer.|At week 24|Analysis is based on all participants with assay data at week 24.|||pg/mL||Inter-Quartile Range|Median
1454242|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Week 12|Results reported are the week 12 IL-6, sTNF-rI and D-dimer.|At week 12|Analysis is based on all participants with assay data at week 12.|||pg/mL||Inter-Quartile Range|Median
1454243|NCT00819390|Secondary|IL-6, Soluble TNF-rI (sTNF-rI) and D-dimer at Baseline|Baseline IL-6, sTNF-rI and D-dimer were computed as the mean of pre-entry and entry IL-6, sTNF-rI and D-dimer, respectively.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||pg/mL||Inter-Quartile Range|Median
1454244|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 24|Results reported are the week 24 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.|||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
1454245|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Week 12|Results reported are the week 12 percentage of CD4 expressing HLA-DR+/CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.|||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
1454246|NCT00819390|Secondary|Percent CD4 HLA-DR+/CD38+ at Baseline|Baseline CD4 HLA-DR+/CD38+ is computed as the mean of pre-entry and entry CD4 HLA-DR+/CD38+.|At pre-entry and entry|Analysis is based on all participants with assay data at pre-entry or entry.|||percent of CD4 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
1454247|NCT00819390|Secondary|Percent CD8 CD38+ at Week 24|Results reported are the week 24 percentage of CD8 expressing CD38+.|At Week 24|Analysis is based on all participants with assay data at week 24.|||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
1454248|NCT00819390|Secondary|Percent CD8 CD38+ at Week 12|Results reported are the week 12 percentage of CD8 expressing CD38+.|At Week 12|Analysis is based on all participants with assay data at week 12.|||percent of CD8 expressing CD38+||Inter-Quartile Range|Median
1454255|NCT00819390|Secondary|Number of Participants With Events Grade 3 or Higher|Events included signs and symptoms, laboratory abnormalities and/or clinical events grade 3 or higher which were described by site clinician blinded to the treatment arm as definitely or possibly related to the study treatment.|From start of study treatment to study completion at week 28|Analysis is based on all enrolled participants, off-ART and on-ART, who received study treatment.|||participants|||Number
1454256|NCT00819390|Secondary|Change in Total CD4 T Cell Count From Baseline to Week 12|Baseline CD4 count (mean of pre-entry and entry CD4 count) is subtracted from the mean of week 10 and week 12 CD4 count|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||cells/mm^3||Inter-Quartile Range|Median
1454257|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 24 in Arm A and Arm C|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|At Pre-entry, entry, Weeks 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
1454258|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Week 12 to Week 24|The mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ is subtracted from the mean of the week 22 and week 24 percent CD8 HLA-DR+/CD38+|At Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at weeks 10 or 12, and 22 or 24, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
1454259|NCT00819390|Secondary|Change in Percent CD8 HLA-DR+/CD38+ From Start to End of the 12-week Chloroquine Treatment Period|For Arm A: Chloroquine then Placebo for off-ART participants and Arm C: Chloroquine then Placebo for on-ART participants, the baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+. For Arm B: Placebo then Chloroquine for off-ART participants and Arm D: Placebo then Chloroquine for on-ART participants, the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+ was subtracted from the mean of week 22 and week 24 percent CD8 HLA-DR+/CD38+.|For Arms A and C: Pre-entry, entry, weeks 10 and 12. For Arms B and D: Weeks 10, 12, 22 and 24|Analysis used a modified as-treated approach, limited to participants with assay data at the required time points, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
1454260|NCT00819390|Primary|Change in Percent CD8 HLA-DR+/CD38+ From Baseline to Week 12|The baseline percent CD8 HLA-DR+/CD38+ (mean of pre-entry and entry percent CD8 HLA-DR+/CD38+) was subtracted from the mean of week 10 and week 12 percent CD8 HLA-DR+/CD38+.|At pre-entry, entry, weeks 10 and 12|Analysis used a modified as-treated approach, limited to participants with assay data at baseline and weeks 10 or 12, and with no break in study treatment for >=14 days. Off-ART analysis excluded participants who started ART. On-ART analysis excluded participants who stopped ART or had virologic rebound (confirmed HIV-1 RNA>1000 copies/mL).|||percent of CD8 expressing HLA-DR+/CD38+||Inter-Quartile Range|Median
1454261|NCT00819286|Primary|Activity Based Total Visual Analog Pain Score|"Postoperative VAS pain scores (scale of 0-10 for each; 0= no pain, 10= worst pain imaginable) were evaluated as a function of resting, coughing, sneezing and general movement. The sum of these was used to derive an Activity Based Total Visual Analog Pain Score, (scale of 0-40; 0= no pain, 40= worst pain imaginable). For this primary endpoint analysis, the total score at 6 months was evaluated."|6 months|All patients with VAS pain data at 6 months were included in the analysis of the primary endpoint Activity Based Total Visual Analog Pain Score.|||units on a scale||Standard Deviation|Mean
1454262|NCT00819286|Primary|CT Scan Evaluation of Sternal Bone Healing|Quantitative evaluation of sternal bone healing at 5 anatomical locations along the sternum using a 6 point quantitative scale (0= no healing and 5= complete healing)|3 and 6 Months|Patients were randomized to receive a CT scan at either 3 or 6 months. All patients who received a CT scan were included in the analysis.|||units on a scale||Standard Deviation|Mean
1454263|NCT00819260|Secondary|Hematoma|A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery.|first day after surgery|entire study population|||participants|||Number
1454264|NCT00819260|Secondary|Pain Level in Surgical Sites|An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable.|first week after surgery|all study participants|||units on a scale||Standard Deviation|Median
1454265|NCT00819260|Secondary|Volume of Drainage in Surgical Drains|An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour.|within one week of surgery|All participants in the study.|||mL/hour||Standard Deviation|Median
1454266|NCT00819260|Primary|Time for Operation|Time to complete the breast reduction per breast.|day of surgery|Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery.|||minutes||Standard Deviation|Median
1454267|NCT00819247|Secondary|Percentage Change in Vital Signs and Body Weight|Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline.|Baseline and Six months|Safety population.|||percentage||Full Range|Median
1454268|NCT00819247|Secondary|The Number of Participants With Abnormal Liver Function Tests|The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN.|Six months|Randomized (Safety) population|||participants|||Number
1454270|NCT00819247|Secondary|Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen|Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4.|Six months|per protocol population|||participants|||Number
1454271|NCT00819247|Secondary|Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24|Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response.|Weeks 4-24|Per protocol population|||participants|||Number
1454272|NCT00819247|Secondary|Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24||Weeks 4-24|Per protocol population|||participants|||Number
1454273|NCT00819247|Primary|Number of Participants With Testosterone <0.5 Nanogram/Milliliter||Weeks 1,2,4,8,12,16,20,24|Per protocol population|||participants|||Number
1454274|NCT00819234|Secondary|Number of Participants With Treatment Emergent Positive Anti-leptin Antibody Titers at Week 52 and at Follow up by Metreleptin Dose - Intent to Treat Population|Baseline refers to Day 1. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred on Days 3 - 28 after treatment ended. Serum titer determinations for antibodies to metreleptin were made using a validated electrochemical luminescence (ECLA) bridging assay. Antibody titers were assessed according to the following dilutions: 0, 5, 25, 125, 625, 3125, 15625, and 78125. Participants were considered to have a positive titer to treatment-emergent antibodies to metreleptin at a given visit if they had a titer >=5 following a negative or missing titer at baseline or if they had a titer that had increased by at least 2 dilutions from a detectable level at baseline.|Baseline to end of treatment follow up|N for Week 52 presented above. For Follow up: N=18,58,68,11,7,8.|||participants|||Number
1454275|NCT00819234|Secondary|Number of Chemistry Laboratory Values of Potential Clinical Importance Observed From DFA102E Baseline to Week 52 - Intent to Treat Population|Baseline defined in study DFA102E as Week 28. Criteria for laboratory values of potential clinical importance for obese and overweight (BMI>=25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L;bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL. Laboratory values obtained at Weeks 28, 36, 44, and 52; number of values a|Baseline to Week 52|All Enrolled participants who received at least one injection of any study medication in Study DFA102E; had laboratory data available. Number analyzed presented above is at Week 52; Number analyzed at Week 28: N= 31, 35, 36, 28, 13, 14, 13, 29, 37, 37.|||Number of Laboratory values|||Number
1454276|NCT00819234|Secondary|Number of Hematology or Urinalysis Laboratory Values of Potential Clinical Importance Observed From Baseline of DFA102E to Week 52 - Intent to Treat Population|Baseline defined as Week 28 (first week of study DFA102E). Hematology: Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urinalysis: Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large. Laboratory values were obtained at Weeks 28, 36, 44, and 52. Numbers of values are cumulative across the extension|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; participants had laboratory data available; platelet counts: n=19 in second arm (not 20); n=20 in fourth arm (not 22); n=11 in fifth arm (not 12);|||number of laboratory values|||Number
1454277|NCT00819234|Secondary|Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population|A 12-Lead electrocardiogram (ECG) was obtained. The PR interval, which is the time from beginning of the P wave to the beginning of the QRS complex (Note: QRS complex is a name for the combination of 3 of the graphical deflections seen in an ECG); QRS interval, which is time from the beginning to the end of the QRS complex; QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec).|Screening to Week 52|Enrolled and received at least 1 injection of any treatment; had ECG data available at Week 52.|||msec||Standard Deviation|Mean
1454278|NCT00819234|Secondary|Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Heart rate was measured while the participant was sitting and was measured in beats per minute (bpm).|Baseline to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.|||bpm||Standard Deviation|Mean
1454279|NCT00819234|Secondary|Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population|Baseline refers to Day 1 of original study DFA102. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Blood pressure was taken while the participant was sitting and was measured in millimeters of mercury (mm Hg).|Baseline (Day 1) to Week 52|Enrolled and received at least 1 injection of any treatment; had data available.|||mm Hg||Standard Deviation|Mean
1454292|NCT00819234|Secondary|LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Weeks 12 and 28 were in original study (Week 28 was baseline for extension study), while Weeks 36, 44, and 52 were in the extension study. Body weight was measured in kilograms (kg).|Original baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||kg||95% Confidence Interval|Least Squares Mean
1454280|NCT00819234|Secondary|Total Trough Concentration of Plasma Leptin at Baseline and at Weeks 40, 52, and End of Treatment Follow up - Week 52 Stable Evaluable Population|Mean fasting plasma total leptin concentration (nanograms per milliliter; ng/mL) change from baseline over time by pooled metreleptin dose (sex, baseline BMI category, and baseline value). Baseline defined as Day 1 in DFA102 study and Week 28 in study DFA102E. If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Follow up occurred 3-28 days after end of treatment. Leptin concentrations were measured using a validated immunoenzymetric assay utilizing polyclonal capture antibody, monoclonal detection antibody, and colorimetric readout by Amylin Pharmaceuticals, Inc. Week 52 Stable Evaluable: Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.|Baseline to end of treatment follow up|number (n) of participants who are Week 52 evaluable in a stable treatment sequence (received the same treatment in both DFA102 and DFA102E) and who had follow up data. Week 52 in Metreleptin 2.5 mg arm n=55 (all others n=56); Week 40 in Metreleptin 5 mg arm n=66 (all others n=68)|||ng/mL||Standard Error|Geometric Mean
1454281|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in the Epworth Sleepiness Scale (ESS) Total Score – Week 52 Evaluable Population|The Epworth Sleepiness Scale (ESS) is an eight-item questionnaire that assesses sleep propensity in daily situations of increasing sleepiness on a four-point scale with 0=would never doze and 3=high chance of dozing. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
1454282|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Hospital Anxiety and Depression Scale (HADS) Total Scores – Week 52 Evaluable Population|The HADS is a questionnaire that uses 14 items to assess both anxiety and depression over the past week. The odd numbered items constitute the anxiety subscale, and the even numbered items constitute the depression subscale. The individual response scores for each subscale component are added together to obtain the individual subscale scores. The minimum and maximum score for each subscale is 0 and 21, respectively. Lower scores show improvement. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
1454283|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening to Week 52 in Extension Study DFA102E in Binge Eating Scale (BES) Total Score - Week 52 Evaluable Population|The Binge Eating Scale (BES) is a 16-item questionnaire that assesses the behavioral and cognitive correlates of binge eating, including participants' perceived self-control over eating behavior using a range of 1 to 4 with 1=positive perceptions and 4= negative perceptions. Lower scores show improvement. The minimum and maximum score for the BES instrument is 0 and 55, respectively; the higher the score the worse the outcome. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
1454284|NCT00819234|Secondary|Mean Absolute Change From Original Study DFA102 Screening at Week 52 in Extension Study DFA102E in Susceptibility to Eating Questionnaire (SEQ) Item Scores – Week 52 Evaluable Population|The eating questionnaire is an exploratory measure of appetite, satiety, and perceived control over portion size using 10 items, with each response measured on a 100 mm visual analogue scale (VAS). Ranges vary from: Never to Very Often; Not at All Difficult to Extremely Difficult; Not at all Strong to Very Strong). Lower scores show improvement. The Eating Questionnaire instructed participants to rate their responses to these items over the past 7 days. Values were obtained for this questionnaire on Visit 3 in the screening period in DFA102 and at Weeks 28, 40, and 52 in DFA102E.|Screening to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||units on a scale||Standard Deviation|Mean
1454285|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10% and 15% Body Weight Loss From Extension Study DFA102E Baseline (Week 28) to Week 52 - Week 52 Evaluable Population|Baseline in extension study was Week 28; if value was missing or after the first dose in DFA102E, the last available value on or prior to Week 28 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Week 28) to Week 52|Participants analyzed had non-missing data at Week 52. Week 52 Evaluable Population: ITT participants (received at least 1 injection); remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock); no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.|||participants|||Number
1454312|NCT00819156|Secondary|Days to 90 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population|||days||Full Range|Median
1454313|NCT00819156|Secondary|Days to 50 Percent Reduction in Prostate-Specific Antigen|Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.|Day 0 (post dose) to Day 364|ITT population|||days||Full Range|Median
1454286|NCT00819234|Secondary|Number of Participants Achieving at Least 5%, 10%, and 15% of Body Weight Loss From Original Study DFA102 Baseline to Week 52 in Extension Study DFA102E - Week 52 Evaluable Population|Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Percent change in body weight from baseline was categorized: Change greater than (>) 0% (Body weight gain); Change less than, equal to (<=) 0 to > -5% (No body weight change or body weight loss <5%); Change <= -5% (Body weight loss greater than, equal to (>=)5%); Change <= -5% to > -10% (Body weight loss >=5% and <10%); Change <= -10% (Body weight loss ≥10%); Change <= -10% to > -15% (Body weight loss >=10% and <15%); Change <= -15% (Body weight loss >=15%).|Baseline (Day 1) to Week 52|Number analyzed with non-missing data at Week 52. Week 52 Evaluable Population: All ITT participants (received at least 1 injection);remained in the study through Week 52; complied with the protocol (per sponsor prior to database lock);no major deviations; some may have been excluded based on a clinical review of the data prior to database lock.|||participants|||Number
1454287|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E in Total Insulin - Week 52 Evaluable Treatment Stable Population|Total insulin was measured in micro international units per milliliter (µIU/mL). Baseline is Day 1 in original study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data in each treatment group. ITT population (received at least 1 injection) with treatment regimens same in DFA102/DFA102E (stable treatment); completed Week 52; no major protocol deviations in DFA102/102E.|||µIU/mL||95% Confidence Interval|Least Squares Mean
1454288|NCT00819234|Secondary|LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population|Glucose, total cholesterol, triglycerides, low density lipoprotein (LDL), and high density lipoprotein (HDL) were measured in milligrams per deciliter (mg/dL). Baseline was Day 1 in original study DFA102, Week 52 was in extension study DFA102E. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline (Day 1) to Week 52|n=number of participants with non-missing data in each treatment group by test. glucose n=20,20,27,19; total cholesterol n=21,20,27,19; triglycerides n=21,20,27,19; LDL/HDL n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E (stable); completed Week 52; no major protocol deviations in DFA102 or DFA102E.|||mg/dL||95% Confidence Interval|Least Squares Mean
1454289|NCT00819234|Secondary|LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population|Baseline is Day 1 in study DFA102. If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Baseline in the Extension Study was Week 28. Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock).|Baseline to Week 52|n=number of participants with non-missing data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,27,19; Week 36 n=21,20,27,19; Week 44 n=21,20,27,19; Week 52 n=21,20,27,19. ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.|||Percentage of change in weight||95% Confidence Interval|Least Squares Mean
1454290|NCT00819234|Secondary|LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population|Baseline is the baseline in the original study DFA102 (Day 1). If Day 1 value was missing or after the first dose of drug, the last available value on or prior to Day 1 was used. Waist circumference was measured in centimeters (cm). Week 52, treatment stable evaluable population: those participants who enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|Baseline to Week 52|n=number of participants with non-missing waist circumference data at this visit in each treatment group. Week 12 n=21,20,27,19; Week 28 n=21,20,26,19; Week 36 n=21,20,27,19; Week 44 n=20,20,27,19; Week 52 n=21,19,27,19.ITT population with treatment regimens same in DFA102/DFA102E; completed Week 52; no major protocol deviations in DFA102/102E.|||cm||95% Confidence Interval|Least Squares Mean
1454291|NCT00819234|Secondary|Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population|Baseline is Day 1 in original study DFA102, baseline in DFA102E is Week 28. Follow up is 3 - 28 days after the end of treatment period. As total leptin is measured, placebo arm was not included in the evaluation. Fasting total leptin is measured in nanograms per milliliter (ng/mL). The assay for measuring total plasma leptin is not specific for metreleptin and detects both endogenous leptin and exogenous metreleptin.|Original Study Baseline to Extension Week 52 and follow up|Enrolled and received at least 1 injection of metreleptin; treatment regimens same in both DFA102/DFA102E (stable population); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension.|||ng/mL||Standard Error|Geometric Mean
1454314|NCT00819156|Secondary|Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.|Day 3|ITT population.|||participants|||Number
1454315|NCT00819156|Secondary|Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.|The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.|Day 28|ITT population.|||participants|||Number
1454687|NCT00815659|Secondary|Basal Small HDL Subfraction Level|Small HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Small HDL subfraction of participants|||mg/mL||Standard Deviation|Mean
1454293|NCT00819234|Primary|LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population|Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.|Original Study Baseline to Week 52|Enrolled and received at least 1 injection of any treatment (ITT); treatment regimens same in both DFA102/DFA102E (stable); evaluable: completed Week 52; complied with protocol, (per Sponsor prior to database lock); no major deviations during original study/extension. Additional exclusions based on clinical review of the data prior database lock.|||percentage of change in weight||95% Confidence Interval|Least Squares Mean
1454294|NCT00819182|Other Pre-specified|Intervention Adherence|Number of breathing practice sessions per participant over the 16 week study period.|16 weeks||||Total practice sessions in 16 weeks||Standard Deviation|Mean
1454295|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted at the week 16 post-randomization timepoint.|16 weeks||||Breaths Per Minute||Standard Deviation|Mean
1454296|NCT00819182|Other Pre-specified|Intervention Performance|Physiological recordings of number of breaths per minute to verify correct performance of paced respiration for this participant group only. Assessment was conducted in a single visit scheduled 2 weeks post-randomization for the paced respiration group.|2 weeks||||Breaths Per Minute||Standard Deviation|Mean
1454297|NCT00819182|Primary|Hot Flash Bother|Self-reported rating using a scale from 0 (not at all bothersome) to 10 (extremely bothersome). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
1454298|NCT00819182|Primary|Hot Flash Severity|Self-reported rating using a scale from 0 (not at all severe) to 10 (extremely severe). Calculated as 24 hour averages at 16 week timepoint.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
1454299|NCT00819182|Secondary|Sleep Disturbance|Self-report using the Pittsburgh Sleep Quality Index which is composed of 19-items to assess sleep quality and disturbances during the past week. Scores range from 0-21 with higher scores indicating poorer sleep quality and more sleep disturbance.|16 weeks||||Global Sleep Disturbance Score||Standard Deviation|Mean
1454300|NCT00819182|Secondary|Mood Disturbance|Self-report using the well-validated Profile of Mood States-Short Form questionnaire. Six subscales are computed. Total scores are computed using the formula Depression-Dejection + Tension-Anxiety + Anger-Hostility + Fatigue-Inertia + Confusion-Bewilderment + (24 - Vigor-Activity). Total scores range from 0 to 124 with higher scores indicating higher mood disturbance.|16 weeks||||Scores on a scale||Standard Deviation|Mean
1454301|NCT00819182|Secondary|Perceived Control Over Hot Flashes|Self-report using well-validated, standardized questionnaire composed of 15 items with response option ratings of 1-4. Scores were summed with potential range of 15-60. Lower scores indicated less control over hot flashes; higher scores indicate higher perceived control over hot flashes.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
1454302|NCT00819182|Secondary|Hot Flash Related Daily Interference|Self-report using well-validated, standardized questionnaire. Subject rated interference on scale items from 0 to 10. Total score range was 0-100 with higher scores indicating greater interference with daily life.|16 weeks|Analysis based on all randomized participants.|||Scores on a scale||Standard Deviation|Mean
1454303|NCT00819182|Primary|Hot Flash Frequency|Prospective, real-time electronic diary used by participants for a minimum of 24 hours to a maximum of 7 days. Duration of use was determined by participant choice.|16 weeks|Analysis based on all randomized participants.|||Hot flashes per 24 hr||Standard Deviation|Mean
1454304|NCT00819156|Secondary|The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight|Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.|Day 364|ITT population|||participants|||Number
1454305|NCT00819156|Secondary|The Number of Patients With Abnormal Liver Function Tests|The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.|364 days|ITT population|||participants|||Number
1454306|NCT00819156|Secondary|Median Values for Follicle Stimulation Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population|||international units / liter||Full Range|Median
1454307|NCT00819156|Secondary|Median Values for Serum Luteinizing Hormone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population|||international units / liter||Full Range|Median
1454308|NCT00819156|Secondary|Median Values of Di-Hydrotestosterone||Day 0 (Baseline), Days 1, 3, 7, 14, and 364|ITT population|||picogram / milliliter||Full Range|Median
1454309|NCT00819156|Secondary|Median Prostate-specific Antigen Levels||Day 0 (Baseline), Days 3, 7, 14, and 364|ITT population|||nanogram / milliliter||Full Range|Median
1454310|NCT00819156|Secondary|Median Serum Testosterone Levels||Day 0 (Baseline), Days 1,3,7,14, and 364|ITT population|||nanogram/milliliter||Full Range|Median
1454311|NCT00819156|Secondary|Days to Prostate-Specific Antigen Progression|Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.|Day 0 (post dose) to Day 364|Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.|||days||Full Range|Median
1454316|NCT00819156|Secondary|Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28|Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.|Day 28 - 364|ITT population of patients with testoterone measurements <=0.5 nanogram/milliliter at Day 28.|||participants|||Number
1454317|NCT00819156|Primary|Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364|Number of patients who achieved a testosterone level considered a castration level.|12 months|ITT population.|||participants|||Number
1454318|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Change from baseline reflects the Week 12 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 12|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1454319|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 6|Change from baseline reflects the Week 6 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 6|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1454320|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).|||percent||Standard Error|Least Squares Mean
1454321|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12|HbA1c is measured as a percent. The change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 12|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).|||percent||Standard Error|Least Squares Mean
1454322|NCT00819091|Secondary|Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6|HbA1c is measured as a percent. The change from baseline reflects the Week 6 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 6|FAS patients. Mixed Model Repeated Measurements (MMRM) analysis of Observed Cases (OC).|||percent||Standard Error|Least Squares Mean
1454323|NCT00819091|Secondary|Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18|An efficacy response is defined as HbA1c lowered by 0.5% or more at 18 weeks. A non-response is defined as HbA1c not lowered by 0.5% or more at 18 weeks.|Baseline, week 18|FAS patients. Non-completers were considered as failure imputation (NCF).|||percentage of participants|||Number
1454324|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18|An absolute efficacy response is defined as HbA1c < 6.5% at 18 weeks. A non-response is defined as HbA1c >= 6.5% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of participants|||Number
1454325|NCT00819091|Secondary|Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18|An absolute efficacy response is defined as HbA1c < 7.0% at 18 weeks. A non-response is defined as HbA1c >= 7.0% at 18 weeks.|week 18|FAS patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||Percentage of Patients|||Number
1454326|NCT00819091|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 18|Change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of FPG. Last observation carried forward (LOCF) was used as the imputation rule.|||mg/dL||Standard Error|Least Squares Mean
1454327|NCT00819091|Primary|Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18|HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline, week 18|Full Analysis Set includes all randomized patients with baseline and on-treatment value of HbA1c. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Least Squares Mean
1454328|NCT00819052|Secondary|Trough Plasma Concentration|Trough plasma concentrations of Nevirapine at steady state after multiple oral administrations of Nevirapine treatments from day 1 (visit 2) to week 48 (visit 9).|Day 1 to week 48|All patients with evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1454329|NCT00819052|Secondary|Genotypic Resistance Associated With Virologic Failure|"Genotypic resistance associated with virologic failure.~This endpoint was not analysed due to lack of data."|48 weeks|All patients in the treated set who experienced virologic failure.||||||
1454330|NCT00819052|Secondary|Time to Loss of Virologic Response|Kaplan-Meier Estimates of time to loss of virologic response defined as the time between the start of treatment and the time of treatment failure, up to and including the time when the last patient was on treatment for 48 weeks.|48 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||days||95% Confidence Interval|Median
1454331|NCT00819052|Secondary|New AIDS or AIDS-related Progression Event or Death||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
1454332|NCT00819052|Secondary|Occurence of Hepatic Events||144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
1454333|NCT00819052|Secondary|Occurence of Rashes|drug-related rashes by severity|144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
1454334|NCT00819052|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of investigations related to treatment|until week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.|||participants|||Number
1454336|NCT00819052|Secondary|Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 144.|||participants|||Number
1454337|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population||baseline, last available visit (up to 144 weeks)|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and last visit (up to 144 weeks).|||cells/cubic millimeter||Standard Deviation|Mean
1454338|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population||baseline, week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 144.|||cells/cubic millimeter||Standard Deviation|Mean
1454339|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population||baseline, week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 132.|||cells/cubic millimeter||Standard Deviation|Mean
1454340|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population||baseline, week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 120.|||cells/cubic millimeter||Standard Deviation|Mean
1454341|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population||baseline, week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 108.|||cells/cubic millimeter||Standard Deviation|Mean
1454342|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population||baseline, week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 96.|||cells/cubic millimeter||Standard Deviation|Mean
1454343|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population||baseline, week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 84.|||cells/cubic millimeter||Standard Deviation|Mean
1454344|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population||baseline, week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 72.|||cells/cubic millimeter||Standard Deviation|Mean
1454345|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population||baseline, week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 60.|||cells/cubic millimeter||Standard Deviation|Mean
1454346|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population||baseline, week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants with CD4 counts at baseline and week 48.|||cells/cubic millimeter||Standard Deviation|Mean
1454347|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response at their last available visit|last available visit, up to 144 weeks|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at last visit (up to 144 weeks).|||participants|||Number
1454348|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 144|week 144|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 144.|||participants|||Number
1454349|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 132|week 132|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 132.|||participants|||Number
1454350|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 120|week 120|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 120.|||participants|||Number
1454351|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 108|week 108|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 108.|||participants|||Number
1454352|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 96|week 96|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 96.|||participants|||Number
1454353|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 84|week 84|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 84.|||participants|||Number
1454354|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 72|week 72|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 72.|||participants|||Number
1454355|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 60|week 60|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to patients present at week 60.|||participants|||Number
1454356|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 48|week 48|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants present at week 48.|||participants|||Number
1454357|NCT00819052|Secondary|Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment.The population was restricted to participants who had CD4 count at baseline and week 24.|||cells/cubic millimeter||Standard Error|Least Squares Mean
1454358|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population||baseline, week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 24.|||cells/cubic millimeter||Standard Deviation|Mean
1454359|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population||baseline, week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 12.|||cells/cubic millimeter||Standard Deviation|Mean
1454360|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population||baseline, week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 8.|||cells/cubic millimeter||Standard Deviation|Mean
1454361|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population||baseline, week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 4.|||cells/cubic millimeter||Standard Deviation|Mean
1454362|NCT00819052|Secondary|Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population||baseline, week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline and week 2.|||cells/cubic millimeter||Standard Deviation|Mean
1454363|NCT00819052|Secondary|Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population||week 0|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment. The population was restricted to participants who had CD4 count at baseline.|||cells/cubic millimeter||Standard Deviation|Mean
1454364|NCT00819052|Secondary|Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population||week 0 to 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||proportion of participants|||Number
1454365|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
1454366|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 12|week 12|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
1454367|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 8|week 8|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
1454690|NCT00815659|Secondary|Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Large HDL subfraction levels of participants|||mg/mL||Standard Deviation|Mean
1454368|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 4|week 4|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
1454369|NCT00819052|Secondary|Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population|Endpoint was the number of patients with a sustained virologic response through week 2|week 2|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
1454370|NCT00819052|Primary|Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population|Primary endpoint was the number of patients with a sustained virologic response through week 24|week 24|Full Analysis Set (FAS) includes all participants randomized to treatment and confirmed to have taken at least one dose of treatment|||participants|||Number
1454371|NCT00819039|Secondary|Number of Participants With Vomiting Frequency in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
1454372|NCT00819039|Secondary|Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.|Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
1454373|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2||Up to 48 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
1454374|NCT00819039|Secondary|Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2|Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.|Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
1454375|NCT00819039|Secondary|Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2||Up to 24 Hours|The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.|||Participants|||Number
1454376|NCT00819039|Primary|Number of Participants Discontinuing Study Treatment Due to AEs||Day 1|The population consists of all participants that received at least one dose of study medication.|||Participants|||Number
1454377|NCT00819039|Primary|Number of Participants Experiencing Adverse Events (AEs)||Up to 21 Days Post-Surgery|The population consists of all participants that received at least one dose of study medication.|||Participants|||Number
1454378|NCT00819039|Primary|Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1|The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C48 hr data were available.|||ng/mL||Standard Deviation|Mean
1454379|NCT00819039|Primary|Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that >50% of measurements were below the lower level of quantitaion (LLOQ).|24 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which C24 hr data were available.|||ng/mL||Standard Deviation|Mean
1454380|NCT00819039|Primary|Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Tmax data were available.|||Hours||Full Range|Median
1454381|NCT00819039|Primary|Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.|48 Hours Post-Dose|The population consisted of all participants that received at least one dose of study medication and for which Cmax data were available.|||ng/mL||Standard Deviation|Mean
1454382|NCT00819039|Primary|Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1|Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.|Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose|The population consisted of all participants that received at least one dose of study medication and for which AUC0-48 data were available.|||hr*ug/ml||Standard Deviation|Mean
1454383|NCT00819013|Secondary|Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.~Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods"|Day 0 and Day 15 through Month 10 Post-vaccination 1|Seropositivity to Hepatitis B core antigen was assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||Participants|||Number
1454396|NCT00818961|Secondary|Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant|patients experiencing acute graft versus host disease post-transplant|patients were followed for 2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of acute graft versus host disease post-transplant.|||participants|||Number
1454384|NCT00819013|Secondary|Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 15 through Month 10 post-vaccination 1|Antibody responses were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.|||1/diultion (1/dil)||95% Confidence Interval|Geometric Mean
1454385|NCT00819013|Secondary|Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
1454386|NCT00819013|Secondary|Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|"Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).~A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)."|Day 0 and Day 60 Post-vaccination 1|Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
1454387|NCT00819013|Secondary|Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 0 and Day 60 Post-vaccination 1|Seroconversion to M2e antigens were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.|||Participants|||Number
1454388|NCT00819013|Primary|Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.|"Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).~A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)"|Day 15 through Month 10 Post-vaccination 1|Geometric mean titers of the respective vaccine antibodies were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population; per-protocol population.|||1/dilution (1/dil)||95% Confidence Interval|Geometric Mean
1454389|NCT00819013|Primary|Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine|Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)|Day 15 through Month 10 Post-vaccination 1|Seroconversion to M2e antigen was assessed participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population.|||Participants|||Number
1454390|NCT00819013|Secondary|Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.|Month 4 through Month 10 post-vaccination 1|Influenza signs and symptoms were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.|||Participants|||Number
1454391|NCT00819013|Primary|Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.||Day 0 through Day 60 post-vaccination 1|Laboratory parameters were assessed in participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations (Intent-to-treat Population).|||Participants|||Number
1454392|NCT00819013|Primary|Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.|Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.|Day 0 through Day 7 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.|||Participants|||Number
1454393|NCT00819013|Primary|Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.||Day 0 through Day 60 post-vaccination|Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.|||Participants|||Number
1454394|NCT00818961|Secondary|Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant|Patients will be evaluated up to 4 years post transplant|4 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of VOD post-transplant|||participants|||Number
1454395|NCT00818961|Secondary|Number of Patients Experiencing Chronic Graft Versus Host Disease||>100 days post-transplant|35 patients survive past 100 days post-transplant and therefore were eligible for evaluation of chronic graft versus host disease|||participants|||Number
1454397|NCT00818961|Secondary|Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism|DLI is used for patients with mixed chimerism following transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for donor leukocyte infusions for mixed chimerism following transplant|||participants|||Number
1454398|NCT00818961|Secondary|Platelet Engraftment|The number of patients experiencing platelet engraftment post-transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of platelet engraftment.|||participants|||Number
1454399|NCT00818961|Secondary|Neutrophil Recovery|The number of patients experiencing neutrophil recovery post transplant|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of neutrophil recovery|||participants|||Number
1454400|NCT00818961|Secondary|Complete Donor Chimerism|Complete donor chimerism (defined as >/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured.|2 years|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of donor chimerism|||participants|||Number
1454401|NCT00818961|Secondary|Non-relapse Mortality at 1 Year Post-transplant|Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive.|1 year|36 patients underwent hematopoietic stem cell transplant. 10 patients died prior to 1 year post-transplant and were eligible for evaluation of non-relapse mortality at 1 year post-transplant|||participants|||Number
1454402|NCT00818961|Secondary|Non-relapse Mortality at Day 100|patients are evaluable for their cause of death at Day 100|Day 100|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of non-relapse mortality at Day 100|||participants|||Number
1454403|NCT00818961|Secondary|Overall Survival at 1 Year|Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant)|1 year|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at one year post-transplant|||participants|||Number
1454404|NCT00818961|Primary|Survival at Day 100|Survival at Day 100|100 day|36 patients underwent hematopoietic stem cell transplant and therefore were eligible for evaluation of overall survival at 100 days|||participants|||Number
1454405|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve both a clinic systolic and diastolic blood pressure response measured at each week indicated, defined as <140/90 mm Hg for participants without diabetes or chronic kidney disease or <130/80 mm Hg for participants with diabetes or chronic kidney disease[GFR <60 mL/min/1.73 m2 or urinary albumin:creatinine ratio (UACR) >200 mg albumin/g creatinine at Screening.] Systolic/diastolic blood pressure is the average of the 3 serial trough sitting systolic/diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||percentage of participants|||Number
1454406|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.|Percentage of participants who achieve a clinic diastolic blood pressure response measured at each week indicated, defined as <90 mm Hg for participants without diabetes or chronic kidney disease or <80 mm Hg for participants with diabetes or chronic kidney disease. Diastolic blood pressure is the average of the 3 serial trough sitting diastolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||percentage of participants|||Number
1454407|NCT00818883|Secondary|Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease|Percentage of participants who achieve a clinic systolic blood pressure response measured at each week indicated, defined as <140mm Hg without diabetes or chronic kidney disease or <130/mm Hg with diabetes or chronic kidney disease. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Week 2, Week 4, Week 6, Week 8 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||percentage of participants|||Number
1454408|NCT00818883|Secondary|Change From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.|The change in the 12-hour mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454409|NCT00818883|Secondary|Change From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454410|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454411|NCT00818883|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454412|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454413|NCT00818883|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at each visit including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454414|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454415|NCT00818883|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at each visit indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454416|NCT00818883|Secondary|Change From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough diastolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454417|NCT00818883|Secondary|Change From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.|The change in trough systolic blood pressure measured at each week indicated including final visit relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454418|NCT00818883|Secondary|Change From Baseline in Trough, Sitting, Clinic Diastolic Blood Pressure|The change in sitting trough clinic diastolic blood pressure measured at each week indicated including final visit relative to baseline. Diastolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454691|NCT00815659|Secondary|Basal Large HDL Subfraction Level|Large HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Large HDL subfraction of participants|||mg/mL||Standard Deviation|Mean
1454419|NCT00818883|Primary|Change From Baseline in Trough, Sitting, Clinic Systolic Blood Pressure|The change in sitting trough clinic systolic blood pressure measured at each week indicated including final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.|Baseline, Week 6 and Week 10.|Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1454420|NCT00818805|Secondary|Change in Total Score in Ocular Symptom Questionnaire||15-180 min.|||||||
1454421|NCT00818805|Primary|Change in “Ocular Itching” Score (5-point Scale) in Subjective Symptom Questionnaire|Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.|0-180 minutes after entering the examination room||||Units on a scale||Standard Deviation|Mean
1454422|NCT00818779|Secondary|Serum Level of Nitric Oxide|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)||||mmmol/l||95% Confidence Interval|Mean
1454423|NCT00818779|Secondary|Serum Level of C-reactive Protein|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)||||mg/l||95% Confidence Interval|Mean
1454424|NCT00818779|Secondary|Serum Level of Intracellular Cell Adhesion Molecule|Surrogate biomarker of cardiovascular risk|6 week (change from baseline)||||ng/ml||95% Confidence Interval|Mean
1454425|NCT00818779|Secondary|Serum Level of Vascular Cell Adhesion Molecule|Surrogate biomarker cardiovascular risk|6 week (change from baseline)||||ng/ml||95% Confidence Interval|Mean
1454426|NCT00818779|Primary|Plasminogen Activator Inhibitor 1|Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.|6 weeks (change from baseline)||||ng/ml||95% Confidence Interval|Mean
1454427|NCT00818766|Secondary|All-Cause Mortality|All-cause mortality is the number of deaths that occurred during the study period, regardless of the cause.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454428|NCT00818766|Secondary|Number of Participants With Allergic Reactions|The number of participants with an allergic reaction to a drug.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454429|NCT00818766|Secondary|Time to Removal of Chest Tubes|Time to removal of chest tubes is the number of days from the time of chest tube placement to time they were removed.|From day of surgery to removal of chest tubes (up to 33 days)|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||days||Full Range|Median
1454430|NCT00818766|Secondary|Length of Hospital Stay|The length of hospital stay is the number of days the participant remained in the hospital.|From day of surgery to discharge (up to 35 days)|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||days||Full Range|Median
1454431|NCT00818766|Secondary|Number of Participants Who Needed Reoperation|The number of participants who needed reoperations for any reason from the time after the first surgery to the end of the 28-day follow-up period.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454432|NCT00818766|Secondary|Number of Participants Who Received Additional Antibiotics for Any Reason Within 28 Days After Surgery|The number of participants who needed any additional non-study antibiotics for any reason after randomization.|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454433|NCT00818766|Primary|Number of Participants Who Experienced Clostridium (C) Difficile Colitis|"C. Difficile Colitis:~Positive for C difficile toxin assay results and any 1 of the following:~new diarrhea~ileus or toxic megacolon~leukopenia (WBC count of <4000/µL) or leukocytosis (WBC count of >11000/µL)~findings from sigmoidoscopy, colonoscopy, or histopathologic examination consistent with C difficile infection"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454434|NCT00818766|Primary|Number of Participants Who Experienced Empyema|"Empyema:~Positive pleural culture result or purulence within the thoracic space and leukocytosis or fever (>38°C)."|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454435|NCT00818766|Primary|Number of Participants Who Experienced Pneumonia|"Pneumonia:~A new infiltrate on chest x-ray associated with at least three of the following:~fever (>38°C)~purulent sputum~leukopenia (white blood cell [WBC] count of <4000/µL) or leukocytosis (WBC count of >11000/µL)~sputum culture with pathogenic bacteria~increased oxygen requirements"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454436|NCT00818766|Primary|Number of Participants Who Experienced Surgical Site Infection|"Surgical Site Infection:~Superficial surgical site infection - involves only skin or subcutaneous tissue around incision and has at least one of the following criteria:~purulent drainage~organisms isolated from aseptically obtained culture~pain or tenderness, localized swelling, redness or heat and the incision deliberately opened by a surgeon~diagnosis of a superficial wound infection by a surgeon~Deep surgical site infection - involves deep soft tissues e.g. fascia or muscle and has at least one of the following:~purulent drainage from the incision but not from the organ/space of the surgical site~deep incision spontaneously dehisces or deliberately opened by surgeon when patient has at least one of following signs or symptoms - fever (>38°C), localized pain or tenderness.~an abscess or evidence of infection involving incision is found on direct examination, histopathologic or radiographic examination~diagnosis of a deep wound infection"|Up to 28 days after surgery|ITT Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454437|NCT00818766|Primary|Number of Participants Who Experienced At Least One Postoperative Infectious Complication|Infectious complications include: surgical site infection, empyema, pneumonia, and the occurrence of Clostridium difficile colitis within 28 days of surgery. Participants are only counted once regardless of how many different infectious complications they had.|Up to 28 days after surgery|Intent-to-Treat (ITT) Population included all participants who were randomized and received their allocated intervention. 1 participant in the antibiotic arm and 2 participants in the placebo arm were randomized twice but are only counted once (per first randomization) in the ITT Population.|||Participants|||Count of Participants
1454438|NCT00818753|Secondary|Number of Participants With Bleeding Events|Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first).|First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)|Treated set. All randomised patients who were documented to have taken at least 1 dose of study drug.|||participants|||Number
1454439|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
1454440|NCT00818753|Secondary|Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
1454441|NCT00818753|Secondary|Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy|Investigator reported outcome|From 22 to 165 minutes|Full analysis set. All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
1454442|NCT00818753|Primary|Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis|Investigator reported outcome|From 22 to 165 minutes|Full analysis set (FAS). All patients who were treated with randomised medication and underwent a cardiac intervention|||Percentage of participants|||Number
1454443|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Rash|Participants requiring systemic therapy or discontinuation from further treatment|Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
1454444|NCT00818662|Secondary|Number of Participants Experiencing a Clinically Significant Decrease in Hemoglobin (>1.5 g/dL) Between Consecutive Visits||Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
1454445|NCT00818662|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an Adverse Event (AE)||Throughout each infusion period|Safety Analysis Set|||Adverse events|Infusions||Number
1454446|NCT00818662|Secondary|Number of Infusions With Causally Associated Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Each adverse event (AE) that was considered related to investigational product (IP) was linked to the most recent infusion administered|Throughout the study period, approximately 4 years|Safety Analysis Set|||Infusions|Infusions||Number
1454447|NCT00818662|Secondary|Number of Infusions Temporally Associated With Non-serious Adverse Events (Non-SAEs) and/or Serious Adverse Events (SAEs)|Refers to non-SAEs and/or SAEs occurring during infusion or within 72 hours of completion of infusion (regardless of causality)|During or within 72 hours of completion of an infusion|Safety Analysis Set|||Infusions|Infusions||Number
1454448|NCT00818662|Secondary|Number of Participants Experiencing Any Serious Adverse Events (SAEs), by System Organ Class|Related and unrelated SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
1454449|NCT00818662|Secondary|Number of Participants Experiencing Any Non-serious Adverse Events (Non-SAEs), by System Organ Class|Related and unrelated non-SAEs|Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
1454450|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Serious Adverse Events (SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
1454451|NCT00818662|Secondary|Number of Participants Experiencing Study Product-related Non-serious Adverse Events (Non-SAEs), by System Organ Class||Throughout the study period, approximately 4 years|Safety Analysis Set|||participants|||Number
1454452|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Clock Drawing Test|In this test, which assesses constructional ability, visuoperception, and executive functioning, the participant is given a blank sheet of paper and asked to draw the face of a clock showing the numbers and 2 hands set to ‘ten after eleven.’ Results are presented as score obtained (range 0 to 5, with 0 indicating the greatest impairment).|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
1454692|NCT00815659|Secondary|LDL-7 Level After 3 Months of Rosuvastatin Treatment|LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-7 levels of participants|||mg/mL||Standard Deviation|Mean
1454453|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part B|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part B range between 0 and 300 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||seconds||Standard Deviation|Mean
1454454|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Trail-Making Test (TMT), Part A|This test, which has 2 parts, is used to assess processing speed, visuomotor and perceptual scanning skills, and executive function. In Part A, 25 circles each containing a number between 1 and 25 are randomly placed on a sheet of paper, and the participant is asked to draw a line as quickly as possible between each circle in ascending numerical order. In Part B, 25 circles are again randomly placed on a sheet of paper; however, in this test 13 of the circles contain the numbers 1 through 13, and the remaining 12 circles contain the letters A through L. In this test, the participant must draw a line as quickly as possible between the circles in alternating between numbers and letters in ascending order (e.g., 1 to A, A to 2, 2 to B,…). Total values for TMT Part A range between 0 and 150 seconds. Results are presented as time to complete; therefore, higher numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||seconds||Standard Deviation|Mean
1454455|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Animals Category Fluency|In this test, which assesses semantic verbal fluency, participants are given 1 minute to name as many items in the category “animals” as possible. To receive credit that word cannot be a mythical animal, but can be an animal species; breed; male, female, or infant name for a species (e.g., bull, cow, calf); in addition, names for birds, fish, reptiles, and insects receive credit. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
1454456|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Symbol Substitution|WAIS–R digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a ‘key,’ which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
1454457|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: FAS Verbal Fluency|In the FAS assessment of phenomic verbal fluency, participants are given 1 minute each to name as many words as they can that begin with a specified letter (F, A, S). To receive credit, words must be verifiable in a dictionary, cannot be proper nouns, and cannot be the same word or variations of the same word (e.g., the same word with a different ending, such as ‘acts,’ ‘acted,’ ‘acting’). Results are presented as total number correct; therefore, lower numbers indicate greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
1454458|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Backward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
1454459|NCT00818662|Secondary|Change From Baseline at 18 Months in the Adjunct Neuropsychological Testing: Wechsler Adult Intelligence Scale- Revised (WAIS-R) Digit Span Forward|This test assesses working memory and attention, the rater asks the participant to repeat single-digit number sequences of increasing length, which are read aloud by the rater (in forward or backward order). Two trials are presented for each sequence length, and the test is ended when the participant misses both trials at a given sequence length. The WAIS-R score ranged from 0-14. Results are presented as total number correct; therefore, lower numbers represent greater impairment.|Baseline & 18 months|Per-Protocol Analysis Set with both baseline and month 18 assessments.|||correct responses||Standard Deviation|Mean
1454460|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Caregiver Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
1454461|NCT00818662|Secondary|Change From Baseline at 18 Months in the Logsdon Quality of Life in Alzheimer's Disease (QOL-AD) Assessment- Participant Response|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant’s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL AD are associated with a lower quality of life.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
1454462|NCT00818662|Secondary|Change From Baseline at 18 Months in the Neuropsychiatric Inventory (NPI) Assessment|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
1454463|NCT00818662|Secondary|Change From Baseline at 18 Months in the Modified Mini-Mental State Examination (3MS) Examination|The 3MS is a comprehensive validated instrument that provides a 100 point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. Scores range from 0 to 100 with lower values indicating greater impairment.|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
1454464|NCT00818662|Secondary|Change From Baseline at 18 Months in Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.~A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).~Very much better~Much better~A little better~Same~A little worse~Much worse~Very much worse"|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||participants|||Number
1454465|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Assessment|"The ADCS-CGIC is a validated categorical measure of change in a participant’s clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating.~A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).~Very much better~Much better~A little better~Same~A little worse~Much worse~Very much worse"|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.|||participants|||Number
1454466|NCT00818662|Secondary|Change From Baseline at 9 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 9 Months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.|||Scores on a scale||Standard Deviation|Mean
1454467|NCT00818662|Secondary|Change From Baseline at 9 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 9 months|Intent-to-Treat Analysis Set with both baseline and month 9 assessments.|||Scores on a scale||Standard Deviation|Mean
1454468|NCT00818662|Primary|Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline & 18 Months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
1454469|NCT00818662|Primary|Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer’s Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline & 18 months|Intent-to-Treat Analysis Set with both baseline and month 18 assessments.|||Scores on a scale||Standard Deviation|Mean
1454470|NCT00818649|Secondary|Correlation of Cell Alterations With Clinical Response|Analysis of Natural Killer (NK) Cell Activating and Inhibitory Receptor Alterations, NK Cell Receptor Ligand Alterations, HLA Class I Expression on Target Cells (Myeloid Blasts), and NK-mediated Cell Killing|Pre-Study and After 3 Cycles|Natural Killer cell studies were discontinued after the first 3 patients because the results were not helpful. So, secondary outcome measures were not completed.||||||
1454471|NCT00818649|Secondary|Correlative Laboratory Studies|Analysis of Natural Killer (NK) Cell Activating and Inhibitory Receptor Alterations, NK Cell Receptor Ligand Alterations, HLA Class I Expression on Target Cells (Myeloid Blasts), and NK-mediated Cell Killing|Pre-Study and After 3 Cycles|Natural Killer cell studies were discontinued after the first 3 patients because the results were not helpful, and thus the secondary outcome measures were not completed.||||||
1454496|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
1454472|NCT00818649|Primary|Number of Patients by Best Clinical Response|Assessed by the International Working Group response criteria: Complete Remission - <5% myeloblasts with normal maturation of all cell lines; Partial Remission - bone marrow blasts decreased by > 50% over pre-treatment but still >5%; and Hematologic Improvement - hemoglobin increase by > 1.5g/dl or decreased transfusions by at least 4/8 week period, platelet absolute increase of >30 X 10^9/L for those starting at >20 X 10^9/L . For those < 20 X 10^9 /L at baseline increase by 100%.|At Completion of Course 3 (Day 63)|Evaluable patients are defined as those who completed at least 1 cycle of therapy; 8 had acute myeloid leukemia, 4 had myelodysplastic syndrome.|||Patients|||Number
1454473|NCT00818623|Secondary|Participants With Markedly Abnormal Change in Vital Signs and Body Weight|Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.|3 months|ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.|||participants|||Number
1454474|NCT00818623|Secondary|Evaluation of Liver Function Tests|The figures presents the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.|3 months||||participants|||Number
1454475|NCT00818623|Secondary|Time to 90% Reduction in Prostate-specific Antigen Levels|The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.|3 months|ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.|||days||Full Range|Median
1454476|NCT00818623|Secondary|Time to 50% Reduction in Prostate-specific Antigen Levels|The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.|3 months|ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.|||days||Full Range|Median
1454477|NCT00818623|Secondary|Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)|Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.|3 months|ITT population|||days||Full Range|Median
1454478|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.|3 months|ITT population.|||participants|||Number
1454479|NCT00818623|Secondary|Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days|The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.|Two - six months|ITT population.|||participants|||Number
1454480|NCT00818623|Primary|Time From Dosing Until Testosterone Levels >0.5 ng/mL|Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.|3 months|ITT population.|||days||95% Confidence Interval|Median
1454481|NCT00818519|Secondary|Percentage of Participants Classified as “Improved” According to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Rating|"The proportion of participants rated as “improved” comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator’s Overall Improvement Rating and those with excellent, good, or fair improvement the Participant’s Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise not improved status."|At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)|FAS (due to missing data number of participants differs from number at Baseline)|||Percentage of participants|||Number
1454482|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones|Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
1454483|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones|Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
1454484|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules|Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
1454485|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules|Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
1454486|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Lesion Count of Papules|Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
1454487|NCT00818519|Secondary|Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS (due to missing data number of participants differs from number at Baseline)|||Percent change||Standard Deviation|Mean
1454488|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 6 (Day 15±3 days of Treatment Cycle 6)|FAS, all participants with data for Cycle 6|||Percentage of participants|||Number
1454489|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 3 (Day 15±3 days of Treatment Cycle 3)|FAS, all participants with data for Cycle 3|||Percentage of participants|||Number
1454490|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Cycle 1 (Day 15±3 days of Treatment Cycle 1)|FAS, all participants with data for Cycle 1|||Percentage of participants|||Number
1454491|NCT00818519|Secondary|Percentage of Participants Classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit|ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions|Screening visit|Full analysis set at screening|||Percentage of participants|||Number
1454492|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|PPS|||Percent change||Standard Deviation|Mean
1454493|NCT00818519|Primary|Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)|Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)*100, so that improvement is indicated by a larger percent change.|Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline|FAS|||Percent change||Standard Deviation|Mean
1454494|NCT00818454|Secondary|Peak FEV1 Response|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.|||liters||Standard Error|Least Squares Mean
1454495|NCT00818454|Secondary|FEV1 AUC0-6 Response (Parallel Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under the Curve from 0 to 6 hours|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|These analyses were done on FAS2. FAS2 is all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had a non-missing Visit 7 baseline value and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 7.|||liters||Standard Error|Least Squares Mean
1454497|NCT00818454|Secondary|Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of open-label albuterol used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
1454498|NCT00818454|Secondary|Puffs Study Medication Used During Night (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during night|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
1454499|NCT00818454|Secondary|Puffs Study Medication Used During Day (Crossover Part of the Study)|Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during day|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Puffs||Standard Error|Least Squares Mean
1454500|NCT00818454|Secondary|Asthma Control Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in ACQ score. Worst score - 6(most severe), best score - 0 (no symptoms)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Scores on scale||Standard Error|Least Squares Mean
1454501|NCT00818454|Secondary|Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)|Change from baseline after 4 weeks in Mini-AQLQ score. Worst score - 1 (most severe), best score - 7 (less severe)|Baseline, 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||Scores on scale||Standard Error|Least Squares Mean
1454502|NCT00818454|Primary|Peak FEV1 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in peak Forced Expiratory Volume response|Test day baseline and test day peak FEV1, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||liters||Standard Error|Least Squares Mean
1454503|NCT00818454|Primary|FEV1 AUC0-6 Response (Crossover Part of the Study)|Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.|Test day baseline and test day FEV1 AUC 0-6, after 4 weeks|Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.|||liters||Standard Error|Least Squares Mean
1454504|NCT00818441|Secondary|Trough Plasma Concentrations (Ctrough) of Dacomitinib|Results for Ctrough were summarized as per the dose received during given cycle: no dose (treatment interruption at any cycle due to treatment-related toxicity), dacomitinib 15 mg (dacomitinib 15 mg at any cycle due to treatment-related toxicity at higher doses), 30 mg (dacomitinib 30 mg at any cycle as starting dose or dose reduction due to treatment-related toxicity at higher doses), 45 mg (dacomitinib 45 mg at any cycle as starting dose or dose escalation due to satisfactory toleration of dacomitinib 30 mg treatment).|Predose on C1D14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis set: all participants who received at least 1 dose of study medication at selected PK sites from whom at least 1 PK sample were obtained. 'N' (number of participants analyzed) = participants who were evaluable for this measure at any time point. n = participants evaluable at given time points for specified dose.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1454505|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Score|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain ). Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results are reported for coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, and other pain. Improvement was defined as a mean decrease from baseline of ≤10. Worsened was defined as a mean increase from baseline of ≥10. Stable was a mean change from baseline of <10.|Baseline (C1D1) up to C75|PRO analysis set: participants who received >=1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. n=participants evaluable at specified time points for given parameter.|||number of participants|||Number
1454514|NCT00818389|Primary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Number of subjects who failed by treatment group was evaluated. Failure was defined as 6-point drop in ALSFRS-R or death from baseline.|9 months: Baseline to study termination (January 2009 - October 2009)||||Participants|||Number
1454515|NCT00818389|Secondary|Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire(ALSFRS-R)|ALSFRS-R is a self-administered ordinal rating scale questionnaire (rating 0-4 for each question,4 is most functional,0-48 total)of 12 functional activities. The most functional total score is 48. ALSFRS-R done at baseline and weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 & 52, dependent on enrollment duration. Secondary efficacy was evaluated by comparing the mean rate of decline of ALSFRS-R score by treatment group.|9 months: Baseline to study termination (January 2009 - October 2009)||||Scores on a scale||Standard Error|Mean
1454506|NCT00818441|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). For GHS, functional scales, symptom scales and single items, scores were averaged, transformed to 0-100 scale; higher score=better level of functioning/health or greater degree of symptoms. Improvement was defined as a mean increase from baseline of ≥10 for GHS and functional scales or a mean decrease from baseline of ≤10 for symptom scales. Worsened was defined as a mean decrease from baseline of ≤10 for GHS and functional scales or a mean increase from baseline of ≥10 for symptom scales. Stable was a mean change from baseline of <10.|Baseline (Cycle [C]1 Day 1), up to C75|Patient reported Outcome (PRO) analysis set:participants who received at least (>=) 1 dose of study medication (as-treated population), had baseline PRO assessments, >=1 on-study assessment submitted. 'N' (number of participants analyzed)=participants evaluable for this measure.n=participants evaluable at specified time points for given parameter.|||number of participants|||Number
1454507|NCT00818441|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last alive date minus the date of first dose of study medication plus 1) divided by 30.44. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Randomization until death or last date known to be alive.|As-enrolled population included all participants who were enrolled in the study.|||months||95% Confidence Interval|Median
1454508|NCT00818441|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause [if not reached, censored date] minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.44. DR was calculated for a subgroup of participants with a confirmed objective tumor response.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|DR was calculated for a subgroup of participants from the response-evaluable population, who had confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
1454509|NCT00818441|Secondary|Best Overall Response (BOR)|BOR: best response recorded from treatment start until disease progression/recurrence based on RECIST v1.0. Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters of target lesions taking as reference baseline sum of longest diameters, associated to non-progressive disease response for non target lesions. PD: >=20% increase in sum of longest diameters of target lesions taking as reference smallest sum of longest diameters since treatment start, or appearance of >=1 new lesion, or unequivocal progression in non-target lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after the initial objective documentation of the response. SD must have met the SD criteria at least once after start of treatment in a minimum interval of 6 weeks.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|Response-evaluable population included all enrolled participants who received at least 1 dose of study medication, had an adequate baseline tumor assessment, and had at least 1 on-study tumor assessment after the first dosing.|||participants|||Number
1454510|NCT00818441|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the first dosing date to the date of first documentation of progression or death due to any cause, whichever occurs first. PFS was calculated as (first event date [if not reached, censored date as the last known event-free date] minus first dosing date plus 1) divided by 30.44. PD: >= 20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions. Documentation of progression was determined from objective disease assessment based on RECIST v1.0 criteria.|Baseline until progression or initiation of new anti-cancer therapy or death, assessed at baseline, at the end of Cycle 1, Cycle 2, and then every other cycle.|As-enrolled population included all participants who were enrolled in the study.|||months||95% Confidence Interval|Median
1454511|NCT00818441|Secondary|Progression-Free Survival (PFS) at Month 4: Cohort B|PFS at Month 4 was defined as percentage of patients who were alive and event free (event defined as PD or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on RECIST v1.0 criteria. PD: >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4||||percent chance of being event-free||95% Confidence Interval|Number
1454512|NCT00818441|Primary|Progression-Free Survival (PFS) at Month 4: Cohort A|PFS at Month 4 was defined as percentage of participants who were alive and event free (event defined as progressive disease [PD] or death due to any cause, whichever occurs first) at 4 months after the first dose of study treatment. Documentation of progression was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria. PD = greater than or equal to (>=) 20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the start of treatment, or the appearance of 1 or more new lesions, or unequivocal progression in non-target lesions.|Baseline up to Month 4|As-enrolled population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
1454513|NCT00818389|Secondary|Vital Capacity (VC) (Percent of Predicted Normal)|Secondary efficacy was measured by comparing the rate of decline of mean VC by treatment group.|9 months: Baseline to study termination (January 2009- October 2009)||||Percent of predicted normal||Standard Error|Mean
1454516|NCT00818337|Secondary|Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg|Aspirin resistance was defined as ARU > 550|2 weeks||||participants|||Number
1454518|NCT00818324|Other Pre-specified|Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score|LGCS indicates the damage to the conjunctival epithelium. Per the National Eye Institute/Industry Workshop report, the conjunctiva was divided into 6 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-18). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52||||LGCS score||Standard Deviation|Mean
1454519|NCT00818324|Primary|Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score|FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).|Baseline, Week2, Week4, Week28, Week52||||FCS score||Standard Deviation|Mean
1454520|NCT00818272|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screeing test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~Missing"|Baseline||||Participants|||Number
1454521|NCT00818272|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline||||Participants|||Number
1454522|NCT00818272|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline||||Participants|||Number
1454523|NCT00818272|Secondary|Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion|The CDAI score is used to quantify the symptoms of participants with CD. The CDAI incorporates 8 items added together that are indicators of disease severity. Scores range from 0 to 600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. A decrease in CDAI over time indicates improvement in disease activity. CDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first Infusion|Data was analyzed for all CD participants whose data had been entered in the database and finalized by signature of the physician. 90 out of 148 participants available at enrollment completed the CDAI and 42 out of the 128 available participants at first infusion after screening (beginning of 2 year observation period) completed the CDAI.|||Score on a scale||Standard Deviation|Mean
1454524|NCT00818272|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician’s awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline||||Participants|||Number
1454525|NCT00818259|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.|Day 1 up to Day 3|The ASaT population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1454526|NCT00818259|Secondary|Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age|Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post dexamethasone dose|This population was to consist of all participants from birth to 1 year of age who received at least one dose of dexamethasone and were evaluable for this PK parameter. These analyses were not conducted; enrollment of this cohort was not opened as enrollment of participants from birth to <6 months of age into Part II was unsuccessful.||||||
1454527|NCT00818259|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.|Up to 14 days after last dose of study drug (Up to 17 days)|The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.|||Participants|||Number
1454537|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Ra Values (Skin Roughness).|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Ra values (skin surface roughness).|Baseline and 4 weeks|Per Protocol|||Percent change post-treatment||95% Confidence Interval|Mean
1454693|NCT00815659|Secondary|Basal LDL-7 Level|LDL-7 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-7 levels of participants|||mg/mL||Standard Deviation|Mean
1454528|NCT00818259|Primary|Tmax for Fosaprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.|||hr||Standard Deviation|Mean
1454529|NCT00818259|Primary|Cmax for Fosaprepitant|Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.|||ng/mL||Standard Deviation|Mean
1454530|NCT00818259|Primary|Apparent Terminal Half-life (t1/2) for Aprepitant|t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||hr||Standard Deviation|Mean
1454531|NCT00818259|Primary|Time to Cmax (Tmax) for Aprepitant|Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||hr||Standard Deviation|Mean
1454532|NCT00818259|Primary|Maximum Plasma Concentration (Cmax) for Aprepitant|Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.|Up to 72 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||ng/mL||Standard Deviation|Mean
1454533|NCT00818259|Primary|Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant|AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.|Up to 24 hours post fosaprepitant/aprepitant dose|The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.|||hr*ng/mL||Standard Deviation|Mean
1454534|NCT00818246|Secondary|Number of Adverse Events.|Signs of erythema, edema, scaling/crusting, bronzing, textural changes, hyperpigmentation, and hypopigmentation were monitored.|Adverse reactions were monitored throughout the study and up to 4 weeks.|Intention to treat (ITT)|||Number of adverse events|||Number
1454535|NCT00818246|Primary|Percent Change From Baseline in Microtopographic Profilometry Rz Values (Rhytid Depth and Severity.|Phaseshift Rapid In vivo Measurement Of Skin (PRIMOS) readings. Analysis of the data in the image is used to generate Microtopographic profilometry Rz values (peak to valley analysis) to quantify rhytid depth and severity.|Baseline and 4 weeks|Per Protocol|||Percent change post-treatment||95% Confidence Interval|Mean
1454536|NCT00818246|Secondary|Change From Baseline in Units on the Fitzpatrick Classification System (FCS) Scale for Degree of Wrinkling.|Clinical qualitative assessment was performed by three blinded medical observers through the evaluation of digital photographs. The photographs were analyzed for clinical improvement using the Fitzpatrick Classification System (FCS)subtype scale for degree of wrinkling (rhytids). Their assessment was rated on a five-point scale and scored as follows; 0=none; 1=mild; 2=moderate; 3=good; 4=excellent.|Baseline and 4 weeks|Per Protocol|||Change in units on the FCS scale||95% Confidence Interval|Mean
1454636|NCT00816777|Primary|Progression Free Survival||1 year|||||||
1454538|NCT00818207|Secondary|Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52|"LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days? and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52"|Week 26 to Week 52|ITT|||Percentage of Participants|||Number
1454539|NCT00818207|Secondary|Percentage of Participants With 7-Day PP of Abstinence at Week 13|"PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?"|Week 13|ITT|||Percentage of Participants|||Number
1454540|NCT00818207|Secondary|Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52|"CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions Have you smoked any cigarettes (even a puff) since the last contact/visit? at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit? and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing."|Week 26, Week 39, and Week 52|ITT|||Percentage of Participants|||Number
1454541|NCT00818207|Secondary|Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco|"PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days? confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL])."|Week 26|ITT|||Percentage of Participants|||Number
1454542|NCT00818207|Primary|Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence|"Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: Have you smoked any cigarettes (even a puff) in the last 7 days? and Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?"|Week 26|Intent to Treat (ITT) Population: all randomized participants|||Percentage of Participants|||Number
1454543|NCT00818168|Secondary|Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion|The BASDAI score was calculated based on the responses to questions 1-6, with each component rated on a scale of 0 (best) to 10 (worst) based on the severity of various characteristics. A decrease in BASDAI over time indicated improvement in disease activity. The score corresponded to the sum of the point values from questions 1-4 and the mean of the point values from questions 5 and 6, subsequently divided by five. BASDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.|Baseline and time of first infusion|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Units on a scale||Standard Deviation|Mean
1454544|NCT00818168|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~Missing"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Participants|||Number
1454545|NCT00818168|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Participants|||Number
1454546|NCT00818168|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||Participants|||Number
1454547|NCT00818168|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:~Yes~Missing (represents no entry, but may mean another test was performed as first screening test and documented)"|Baseline|Data was analyzed for all AS patients whose data was entered into the database and finalized by signature of the physician.|||participants|||Number
1454694|NCT00815659|Secondary|LDL-6 Level After 3 Months of Rosuvastatin Treatment|LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-6 levels of participants|||mg/mL||Standard Deviation|Mean
1454548|NCT00818116|Primary|Uncorrected and Best Corrected Visual Acuities (Near and Distance)|Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 Months Following Cataract Surgery||||logMAR||Standard Deviation|Mean
1454549|NCT00817999|Primary|% Platelet Inhibition|% platelet inhibition measured by Verify Now|6 hours||||percentage of platelet inhibition||Standard Deviation|Mean
1454550|NCT00817843|Primary|Treatment Difference in (Postprandial-Fasting) FMD|A comparison of the postprandial minus fasting change in FMD under treatment with simvastatin 80 mg versus simvastatin 10/10 mg|After 6 weeks of treatment|Analyses were performed in randomized patients who received ≥1 dose of study treatment and who had a post-randomization analysis measurement|||% (change FMD)||Standard Error|Mean
1454551|NCT00817843|Secondary|Preprandial Endopat Measurement||after 6 weeks of treatment (crossover)|||||||
1454552|NCT00817843|Secondary|Preprandial Endothelial Function Measured by FMD||after 6 weeks of treatment (crossover)|||||||
1454553|NCT00817843|Secondary|Postprandial Endopat Measurement||after 6 weeks of treatment (crossover)|||||||
1454554|NCT00817804|Secondary|Blood Pressure|Systolic and diastolic blood pressure|30 minutes|||||||
1454555|NCT00817804|Secondary|Heart Rate|Beats per minute that the patient's heart is beating|30 minutes|||||||
1454556|NCT00817804|Secondary|Minute Ventilation|Liters per minute that the patient breathes|30 minutes|||||||
1454557|NCT00817804|Secondary|Respiratory Rate|Breathing rate in breaths per minute|30 minutes||2011-12-31|12/2011||||
1454558|NCT00817804|Secondary|Saturation of Arterial Oxygen||30 minutes||2011-12-31|12/2011||||
1454559|NCT00817804|Primary|Breathing Comfort|Comfort on visual analog scale 0 - 100, 0 is best|30 minutes|Analysis was per protocol|||visual analog scale||Standard Error|Mean
1454560|NCT00817778|Secondary|S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment||||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
1454561|NCT00817778|Secondary|S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment||||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
1454562|NCT00817778|Secondary|P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment|Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.|Baseline is the day before first dose, end of treatment is last day of treatment||||Relative ratio in percent||95% Confidence Interval|Least Squares Mean
1454563|NCT00817778|Secondary|Apparent Oral Clearance of AZD1656||Measured last day of treatment||||L/h||Full Range|Geometric Mean
1454564|NCT00817778|Secondary|Terminal Elimination Half-life of AZD1656||Measured following the afternoon dose last day of treatment||||h||Full Range|Geometric Mean
1454565|NCT00817778|Secondary|Time to Reach Maximum Plasma Concentration of AZD1656||Measured last day of treatment||||h||Full Range|Median
1454566|NCT00817778|Secondary|Maximum Plasma Concentration of AZD1656|Dose-adjusted to a morning dose of 50 mg due to titrated doses|Measured last day of treatment||||umol/L||Standard Deviation|Geometric Mean
1454567|NCT00817778|Secondary|Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656|Dose-adjusted to a total daily dose of 100 mg due to titrated doses|Measured last day of treatment||||umol*h/L||Standard Deviation|Geometric Mean
1454568|NCT00817778|Primary|Clinically Relevant Change of Laboratory Variables|Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters|Measured regularly from day before first dose to day after last dose||||Participants|||Number
1454569|NCT00817778|Primary|Weight, Change From Baseline to End of Treatment||Baseline is the day before first dose, end of treatment is last day of treatment||||kg||Standard Deviation|Mean
1454570|NCT00817778|Primary|Pulse, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||beats/min||Standard Deviation|Mean
1454571|NCT00817778|Primary|Diastolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
1454572|NCT00817778|Primary|Systolic Blood Pressure, Change From Baseline to End of Treatment||Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period||||mmHg||Standard Deviation|Mean
1454573|NCT00817596|Primary|Demonstrate That Prometra Programmable Pump System Accurately and Safely Delivers Medication in the Intrathecal Space, as Programmed.|"Accuracy was determined by calculation of the delivered to programmed drug volume (DP) ratio. The DP ratio was calculated as the ratio of delivered drug volume (the volumetrically determined delivered drug volume) to the programmed drug volume (the volume of drug that was programmed to be delivered) summed cumulatively for all fill/refills, including any unscheduled visits per patient.~The delivered drug volume over all (scheduled and unscheduled) valid fill/refill sessions was summed together per patient as the numerator and the programmed drug volume over all valid fill/refill sessions was summed together per patient as the denominator to provide a per-patient DP ratio."|6 months - acute study|Sample size was based on previous testing and data from similar devices. With a population of 60 subjects the 90% CI would be 95 ± 7, or 0.88 to 1.02. Therefore, approximately 60 patients with 6-months of data will provide adequate data to demonstrate accuracy, although up to 110 patients may be implanted to account for patient drop-outs.|||% of programmed vol. actually delivered||90% Confidence Interval|Mean
1454574|NCT00817531|Primary|Clinical Efficacy|The clinical response was assessed using RECIST and based on the changes in the longest diameter of the target lesion measured. Complete Response (CR), Disappearance of the target lesion; Partial Response (PR), >=30% decrease in the diameter of target lesion compared to baseline; Progressive disease (PD), >= 20% increase in the diameter of target lession, taking as reference the smallest diameter recorded since the baseline measurement or the appearance of new lesion; Stable disease (SD), neither sufficient shrinkage as PR or sufficient increase as PD.|Assessment at pre-surgery or 3 to 4 weeks of treatment.|All patients started the treatment will be included in the analysis|||participants|||Number
1454575|NCT00817479|Primary|Increase in MKP1/DuSP1 mRNA Expression Level|Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.|||fold change||Standard Error|Mean
1454576|NCT00817479|Primary|Increase in SGK1 mRNA Expression Level|Increase in SGK1 mRNA expression level is calculated as fold change = post / pre|>= 30 min|Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.|||fold change||Standard Error|Mean
1454577|NCT00817336|Secondary|Visual P1||6 weeks|includes subjecst with valid visual p1 data|||micro volts||Standard Deviation|Mean
1454578|NCT00817336|Secondary|MATRICS|MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.|6 weeks|Final score after six weeks|||T score||Standard Deviation|Mean
1454579|NCT00817336|Primary|MMN Amplitude|Final MMN amplitude|6 weeks|Includes 11 subjects with analyzable MMN data|||micro volts||Standard Deviation|Mean
1454580|NCT00817336|Primary|PANSS Total|Positive and Negative Symptom Scale (PANSS) range 30-210|6 weeks|Final score end of six weeks|||units on a scale||Standard Deviation|Mean
1454581|NCT00817219|Secondary|PASI 50 at Week 4.|PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Week 4||||participants|||Number
1454582|NCT00817219|Secondary|PASI 75 at Week 4.|PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|4 weeks||||participants|||Number
1454583|NCT00817219|Secondary|Percentage Change in PASI From Baseline to Week 4.|PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.|Baseline and 4 weeks||||percentage||95% Confidence Interval|Mean
1454584|NCT00817219|Secondary|“Controlled Disease”(i.e., “Clear” or “Very Mild”) According to the Patient’s Global Assessment of Disease Severity at Week 4.|The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).|Week 4||||participants|||Number
1454585|NCT00817219|Secondary|“Controlled Disease”(i.e., “Clear” or “Almost Clear”) According to the Investigator’s Global Assessment of Disease Severity at Week 4.|The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.|Week 4||||participants|||Number
1454586|NCT00817219|Primary|Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.||Baseline and 4 Weeks||||mmol/g||Standard Deviation|Mean
1454587|NCT00817219|Primary|Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment||Baseline and 4 weeks||||mmol/L||Standard Deviation|Mean
1454588|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis|||participants|||Number
1454589|NCT00817219|Primary|Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment|The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.|Week 4|One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis|||participants|||Number
1454590|NCT00817219|Primary|Adverse Drug Reactions|The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as “not related”.|Week 4||||participants|||Number
1454591|NCT00817206|Primary|Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.||12 months|"One patient in each arm were randomized but not treated. Only treated patients (modified ITT population) is included in the primary outcome measure.~One patient death is listed under the Prograf arm; this patient died during follow up and did completet the study."|||participants|||Number
1454688|NCT00815659|Secondary|Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment|Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Intermediate HDL subfraction levels of participants|||mg/mL||Standard Deviation|Mean
1454592|NCT00817063|Secondary|Number of Participants With Adverse Audiological Change as Assessed by Puretone Audiogram at Highest Frequency|An adverse change was defined as a change from normal at Baseline to abnormal at end of therapy. A missing adverse change was defined as missing results at Baseline and end of therapy, or missing result at Baseline and abnormal at end of therapy, or normal at Baseline and missing result at end of therapy. Other changes from Baseline to end of therapy are considered as no adverse change. All puretone testing used a modified Hughson-Westlake procedure with 5 decibel (dB) step size.|Up to Week 24|Safety Population. Only those participants who had audiologic evaluations were analyzed.|||Participants|||Count of Participants
1454593|NCT00817063|Secondary|Number of Participants With Adverse Ophthalmological Change as Assessed by Fundus Photography - Intraocular Pressure|An adverse change was defined as a change from normal at Baseline to abnormal at end of therapy, or as a worsening from Baseline for either or both eyes. A missing adverse change was defined as missing results at Baseline and end of therapy, or missing result at Baseline and abnormal at end of therapy, or normal at Baseline and missing result at end of therapy, or abnormal at Baseline and missing result at end of therapy, for both eyes or one eye when the other eye was not concerned by an adverse change. Other changes from Baseline to end of therapy was considered as no adverse change. Optic disc, macula, and retinal periphery were assessed by fundoscopy after pupil dilation using tropicamide.|Up to Week 24|Safety Population. Only those participants who had ophthalmological evaluations were analyzed.|||Participants|||Count of Participants
1454594|NCT00817063|Secondary|Number of Participants With Adequecy of Images Assessed by X-ray Evaluation of Bones|X-ray evaluations was done at Baseline (Week 0), end of therapy and at follow up period (Week 72). X-ray evaluations was done for Lateral C-Spine, Lateral T-Spine and Calcaneous. The images were evaluated as optimal, readable (but not optimal) or not readable.|Up to Week 72|Safety Population. Only those participants who had X-ray evaluations were analyzed.|||Participants|||Count of Participants
1454595|NCT00817063|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) by Dual Energy X-ray Absorptiometry (DXA) Over 72 Weeks|Bone mineral density scans of the left proximal femur (total hip) and anterior-posterior lumbar spine were obtained by use of DXA, at Baseline, at end of therapy, and 1 year (48 weeks) after end of therapy. In case of abnormality or surgery of the left hip, the right hip was to be used. If both hips were affected, the participant was not eligible for DXA. Vertebrae L1 to L4 had to be completely scanned. At least 3 vertebrae had to be free of any abnormalities potentially interfering with DXA analysis (eg, fractures, large osteophytes), otherwise the participant was not eligible for DXA. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100. Least square means and 95% confidence interval has been presented.|Baseline (Week 0) and Week 72|Safety Population. Only those participants available at the indicated time points were analyzed.|||Percent change||95% Confidence Interval|Least Squares Mean
1454596|NCT00817063|Secondary|Number of Participants Responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) Questionnaire Over 24 Weeks|Participants who developed tinnitus were monitored by use of the TOMI. The numbers of participants with pre-existing tinnitus, new tinnitus, increased/decreased loudness of tinnitus, or increased/decreased duration of tinnitus, pulsing quality of tinnitus were assessed.|Up to Week 24|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1454597|NCT00817063|Secondary|Change From Baseline in Dizziness Handicap Inventory (DHI) Over 24 Weeks|DHI assessed participants by handicap category: no handicap (0 to 14 points); mild handicap (16 to 34 points); moderate handicap (36 to 52 points); severe handicap (54 points). Increase from Baseline of <6 points, 6 to <12 points and 12 points. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.|Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24|Safety Population. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1454598|NCT00817063|Secondary|Change From Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) Over 24 Weeks|HHIE-S assessed participants by handicap category: no handicap (0 to 8 points); mild/moderate handicap (10 to 24 points); severe handicap (26-40 points). Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.|Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24|Safety Population. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1454599|NCT00817063|Secondary|Number of Participants Meeting the Referral Criteria of Psychiatric Evaluation Over 28 Weeks|Participants meeting any of the following criteria were to be referred for specialist psychiatric evaluation within 2 weeks: PHQ-9 Score >=15, Two Subsequent Scores of >=10 and PHQ-9 Question 9 >=1. The PHQ -9 was a standardized tests of mood/depression. This was a nine item measure with a response for each item between 0-3 where, 0=not at all, 1= several days, 2= more than half the days, 3= nearly everyday. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. Only categories with data available at the indicated time points have been presented. Categories with null values for all the arms have not been presented.|Up to 28 Weeks|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1454600|NCT00817063|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9) Score Over 28 Weeks|The PHQ-9 was a standardized tests of mood/depression. This was a nine item measure with a response for each item between 0-3 where, 0=not at all, 1= several days, 2= more than half the days, 3= nearly every day. Total scores on this measure range from 0-27, with 0 being a minimum indicating no depressive symptoms, and 27 being the maximum number and severity of depressive symptoms. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values.|Baseline (Week 0) and Week 4, 8, 12, 16, 20, 24, 28|Safety population. Only those participants available at the indicated time points were analyzed.|||Score on scale||Standard Deviation|Mean
1454647|NCT00816400|Secondary|Time to Response|Time to response was measured from the start of treatment with MEDI-575 to the first documentation of objective response (confirmed CR or PR). The time to response is assessed only for the participants who have achieved the objective response.||Efficacy evaluable population with an objective response. Time to response was not estimable as there were no participants with an objective response.||||||
1454601|NCT00817063|Secondary|Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks|"The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., your feelings being easily hurt) on a 5-point scale where, 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, 4=extremely (0 indicates best outcome and 4 indicates worst outcome). The total score ranged from 0 (best outcome) to 212 (worse outcome). Participants with an increase above Baseline of 25% or more on any domain subscore in BSI-53, or with an increase above Baseline of >=2 points or a score >=3 on any BSI-53 item that reflects depression, suicidality, psychotic symptoms, and hostility/aggression, were to be referred to a psychiatrist within 2 weeks."|Up to Week 24|Safety population. Only those participants meeting the criteria of referring to psychiatrist were analyzed.|||Participants|||Count of Participants
1454602|NCT00817063|Secondary|Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range|Blood samples were collected for the assessment of laboratory parameters hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin concentration, reticulocytes, platelets, white blood cell, lymphocytes, neutrophils, monocytes, eosinophils, basophils, total bilirubin, bilirubin conjugated (direct), aspartate amino transferase (AST), alanine amino transferase (ALT), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), alkaline phosphatase (ALP), total protein, serum albumin, glucose, triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, sodium, potassium, chloride, serum calcium, serum phosphate, serum creatinine, blood urea nitrogen (BUN)/urea, uric acid, Free thyroxin and thyroid stimulating hormone (TSH) at Baseline and every 4 weeks of treatment period and Week 28 of follow up period. Data for participants with values outside the marked reference range are reported.|Up to Week 28|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
1454603|NCT00817063|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period|An AE was defined as any adverse change from the participant’s Baseline (pretreatment) clinical condition, including intercurrent illness, which occurred during the course of the clinical study after written informed consent had been given, whether considered related to treatment or not. A treatment-emergent AE was defined as any adverse change that occurred after treatment started and up to 7 days after last treatment. An SAE was any experience that suggested a significant hazard, contradiction, side effect or precaution. It was any adverse event that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect.|Up to Week 24 (end-of-treatment)|Safety Population included all randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
1454604|NCT00817063|Secondary|Time to Response for Responding Participants at End-of-therapy|Time to response was defined as time from start of treatment to first PGA assessment of “clear” or “almost clear”. Median and inter-quartile range has been presented.|Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)|ITT population. Only those participant who responded to PGA assessment at the end of therapy was analyzed.|||Days||Inter-Quartile Range|Median
1454605|NCT00817063|Secondary|Time to Relapse for Responding Participants at the End-of-therapy|Time to relapse was defined as the time from end-of-therapy to the first diagnosis of severe CHE. Median and inter-quartile range has been presented. The median was based on the very last participant having a follow-up period longer than expected, those explaining the high median.|Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)|ITT population.|||Weeks||Inter-Quartile Range|Median
1454606|NCT00817063|Secondary|Response Duration for Responding Participants at the End-of-therapy|Response Duration was defined as time from the end-of-therapy to the first diagnosis of mild, moderate, or severe CHE. Median and inter-quartile range has been presented.|Up to 72 Weeks (including 24 weeks of treatment and 48 weeks of follow-up)|ITT population.|||Weeks||Inter-Quartile Range|Median
1454607|NCT00817063|Secondary|Percentage Change From Baseline in Extent of Disease at End-of-treatment|The extent of disease was estimated as the percentage of hand area (with 100% defined as the palmar and dorsal aspects) affected by eczema at Baseline, and at the end of treatment). Extent of disease was estimated separately for the left and right hands, and the overall extent of disease for both hands was calculated as (Left+Right)/2. Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100.|Baseline (Week 0) and Week 24 (end-of-treatment)|ITT Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
1454608|NCT00817063|Secondary|Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment|At Week 24 or at the end-of-treatment participants were asked by the investigator to grade their overall change from Baseline by selecting one of the following descriptions, which best matched their perception of overall treatment effect: cleared or almost cleared (at least 90% clearing), marked improvement (at least 75% clearing), moderate improvement (at least 50% clearing), mild improvement (at least 25% clearing), no change and worsening. Participants were considered as responders when the PaGa was cleared or almost cleared.|Week 24 (end-of-treatment)|ITT Population.|||Participants|||Count of Participants
1454609|NCT00817063|Secondary|Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment|A 4-point scale (0=none, 1=mild, 2=moderate, 3=severe) was used to grade 7 signs or symptoms of CHE. The mTLSS was calculated as sum of assigned scores for the symptoms of erythema, scaling, lichenification/hyperkeratosis, vesiculation, edema, fissures and Pruritus/Pain. The total score ranged from 0 (best) to 21 (worst). Baseline was defined at Week 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-baseline values. Percentage change from Baseline = (change from Baseline / Baseline value) * 100. Data for Week 24 last observation carried forward (LOCF) has been presented.|Baseline (Week 0) and Week 24 (end-of-treatment)|ITT population.|||Percent change||Standard Deviation|Mean
1454666|NCT00816101|Primary|Number of Patients Who Experienced 50% or Greater Wound Healing|Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported|3 Weeks||||Participants|||Number
1454610|NCT00817063|Primary|Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24|The investigator assigned PGA grades according to a 5-point scale (clear [not detectable], almost clear [less than 10% of affected hand surface], mild disease [less than 10% of affected hand surface], moderate disease [10% to 30% of affected hand surface], severe disease [>30% of affected hand surface]). PGA ratings were based on an integrated clinical picture of signs, symptoms, and the extent of disease. Symptoms included erythema, scaling, hyperkeratosis/lichenification, vesiculation, edema, fissures, and pruritus/pain. The PGA scale ranges from 0 (no symptom) to 4 (severe disease). Participants were considered as responders when they had a PGA of clear or almost clear.|Week 24 (end-of-treatment)|ITT Population.|||Participants|||Count of Participants
1454611|NCT00816907|Secondary|Change in Hemoglobin A1c From Baseline to 16 Weeks|glycosylated hemoglobin|16 weeks|participants who took assigned treatment|||percent||95% Confidence Interval|Least Squares Mean
1454612|NCT00816907|Secondary|Change in Fasting Insulin From Baseline to 16 Weeks|Fasting insulin|16 weeks|participants who took assigned treatment|||mU/L||95% Confidence Interval|Mean
1454613|NCT00816907|Secondary|Change in Fasting Glucose From Baseline to 16 Weeks|fasting blood glucose|16 weeks|participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
1454614|NCT00816907|Secondary|Change in Triglycerides From Baseline to 16 Weeks|serum triglycerides|16 weeks|participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
1454615|NCT00816907|Secondary|Change in LDL Cholesterol From Baseline to 16 Weeks|low-density lipoprotein|16 weeks|participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
1454616|NCT00816907|Secondary|Change in HDL Cholesterol From Baseline to 16 Weeks|high-density lipoprotein|16 weeks|randomized participants who took assigned treatment|||mg/dL||95% Confidence Interval|Least Squares Mean
1454617|NCT00816907|Secondary|Change in Total Cholesterol From Baseline to 16 Weeks|Total cholesterol|16 weeks|randomized participants who took assigned treatment|||mg/dL||95% Confidence Interval|Mean
1454618|NCT00816907|Primary|Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo|Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks)|Measured at the last study visit|Evaluable population that took assigned study treatment|||kilograms||95% Confidence Interval|Mean
1454619|NCT00816829|Primary|Index of Hypopneas|Average number of hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number per hour of sleep||Full Range|Median
1454620|NCT00816829|Primary|Index of Apneas|Average number of apneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number per hour of sleep||Full Range|Median
1454621|NCT00816829|Primary|Central Apneas|Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of central apneas||Full Range|Median
1454622|NCT00816829|Primary|Mixed Apneas|Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of mixed apneas||Full Range|Median
1454623|NCT00816829|Primary|Index Apnea/Hypopnea|Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number per hour of sleep||Full Range|Median
1454624|NCT00816829|Primary|Hypopneas|Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of hypopneas||Full Range|Median
1454625|NCT00816829|Primary|Apneas|Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of apneas||Full Range|Median
1454626|NCT00816829|Primary|Sleep Time With Oxygen Saturation Below 90%|Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Percentage of sleep time||Full Range|Median
1454627|NCT00816829|Primary|Desaturations|Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.|at one month of treatment|The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate).|||Number of desaturations||Full Range|Median
1454628|NCT00816829|Primary|Obstructive Apneas|Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).|at one month of treatment|The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).|||Number of obstructive apneas||Full Range|Median
1454629|NCT00816777|Secondary|Overall Survival||1 year|||||||
1454630|NCT00816777|Secondary|Performance Status (ECOG)||1 year|||||||
1454631|NCT00816777|Secondary|Change in Tumor Marker||1 year|||||||
1454632|NCT00816777|Secondary|Hepatic Progression Free Survival||1 year|||||||
1454633|NCT00816777|Secondary|Local Tumor Response (Extent of Necrosis in the Treated Lesions)||1 year|||||||
1454634|NCT00816777|Secondary|Tumor Response (RECIST)||1 year|||||||
1454635|NCT00816777|Secondary|Toxicity, Adverse Events and Serious Adverse Events (NCI CTCAE v3.0)||6 weeks|||||||
1454637|NCT00816595|Secondary|Progression-free Survival|The Kaplan-Meier method will be used to estimate progression-free survival distribution. Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.|||months||95% Confidence Interval|Median
1454638|NCT00816595|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival distributions Overall survival is measured as the time from registration to the time of death due to any cause.|Assessed up to 5 years from registration|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.|||months||95% Confidence Interval|Median
1454639|NCT00816595|Primary|Complete and Overall Response Rate|"A Complete Response (CR) requires all of the following for 2 months:~Absence of lymphadenopathy by physical examination (PE)~No hepato- or splenomegaly by PE~Neutrophils >1500/ul, Platelets >100,000/ul. Hemoglobin >11.0 gm/dl, Peripheral blood lymphocytes <4000/uL~Nodular Partial Response (nPR) is defined as a patient qualified for a CR, but regenerative nodules are histologically present on bone marrow samples.~A Clinical Complete Response (CCR) is defined as a patient qualified for a CR, but bone marrow samples are not available.~A Partial Response (PR) requires 50% reduction in 2 of the following: peripheral blood lymphocytes, or the sum of the products of the maximal perpendicular diameters, or the size of liver and/or spleen; and a 50% increase in neutrophils, platelets, or hemoglobin.~Overall response rate is calculated as the number of patients receiving CR, CCR, nPR, or PR as their objective status divided by the total number of evaluable patients."|Evaluated after 6 cycles (up to 196 days)|One patient on Arm A was treated at an incorrect dose level and was not evaluable for this endpoint. On Arm B, one patient did not have correct eligibility reported, one patient did not complete an assessment, and one patient was incorrectly treated. The primary endpoint is based on 32 Arm A and 30 Arm B patients.|||percentage of patients|||Number
1454640|NCT00816556|Secondary|Change in Serum Estradiol (E2) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks||||pg/ml||Standard Deviation|Mean
1454641|NCT00816556|Secondary|Change in Serum Estrone (E1) Levels Between Baseline, 2 Weeks, and 12 Weeks||baseline, 2 weeks, 12 weeks||||pg/ml||Standard Deviation|Mean
1454642|NCT00816556|Primary|Change in Vulvovaginal Atrophy Questionnaire (VVAQ) Scores From Baseline to Week 12|The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome.|baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
1454643|NCT00816400|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the start of treatment with MEDI-575 until death. For the participants who were alive at the end of study or lost to follow-up, OS was censored on the last date when participants were known to be alive.|From the start of treatment with MEDI-575 until death or end of study, up to 33 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure|||Months||95% Confidence Interval|Median
1454644|NCT00816400|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause, whichever occurred first. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. PFS was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.|Start of treatment with MEDI-575 until the documentation of disease progression or death due to any cause whichever occurs first, up to 24 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure|||Months||95% Confidence Interval|Median
1454645|NCT00816400|Secondary|Time to Progression|Time to progression (TTP) is defined as time from the start of treatment with MEDI-575 until the documentation of disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. TTP was censored on the first date of treatment for the participants with no tumor assessments after the start of MEDI-575 treatment.|Start of treatment with MEDI-575 until the documentation of disease progression, up to 24 months|Efficacy evaluable population. N= number of participants analyzed for this outcome measure|||Months||95% Confidence Interval|Median
1454646|NCT00816400|Secondary|Duration of Response|Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression. Disease progression is defined according to RECIST guidelines (ie, at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions). The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was calculated for the subgroup of participants with an objective response.||Efficacy evaluable population with an objective response. Duration of response was not estimable as there were no participants with an objective response.||||||
1454689|NCT00815659|Secondary|Basal Intermediate HDL Subfraction Level|Intermediate HDL subfraction levels before (Visit 2-enrollment)|Baseline|Baseline Intermediate HDL subfraction of participants|||mg/mL||Standard Deviation|Mean
1454648|NCT00816400|Secondary|Percentage of Participants With Objective Response|Objective response rate is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after the initial documentation of response. The CR is defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|From study entry through the end of the study, up to 34 months|Efficacy evaluable population: All participants who have received any treatment of MEDI-575 and at least one tumor assessment after the initiation of MEDI-575.|||Percentage of participants||95% Confidence Interval|Number
1454649|NCT00816400|Secondary|Number of Participants Positive for Anti-drug Antibodies Formation for MEDI-575 at Any Visit|Blood samples for immunogenicity assessments were collected from participants prior to the initiation of infusion of each treatment cycle of MEDI-575. Anti-MEDI-575 antibodies were analyzed using the electro-chemiluminescence (ECL) based method. Only the number of participants positive for anti-MEDI-575 antibodies at any visit are presented.|Preinfusion on Cycle 1 Day 1 and 30 days after the last dose, up to 112 weeks|Safety population|||Participants|||Number
1454650|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Dose-normalized Area Under the Serum Concentration-time Curve (AUCτ/Dose)|The AUCτ/dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.|||μg·day/mL/mg||Standard Deviation|Mean
1454651|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCτ)|The AUCτ was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.|||μg·day/mL||Standard Deviation|Mean
1454652|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Trough Serum Concentration (Ctrough)|The Ctrough ie, measured concentration at the end of a dosing interval (taken directly before next dose administration) of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and from whom PK blood samples were collected and evaluated. Excluded participants were for whom it cannot be calculated (either number of doses received was less than 2 or standard deviation equals 0.000) or where dosing interval is more than 7 days or samples only collected up to 14 days.|||μg/mL||Standard Deviation|Mean
1454653|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Dose-normalized Maximum Serum Concentration (Cmax/Dose)|The Cmax/dose after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.|||μg/mL/mg||Standard Deviation|Mean
1454654|NCT00816400|Secondary|PK of MEDI-575 After the First Dose: Time to Maximum Concentration (Tmax)|The time to reach maximum serum concentration after the first dose of MEDI-575 was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.|||Day||Standard Deviation|Mean
1454655|NCT00816400|Secondary|Pharmacokinetics (PK) of MEDI-575 After the First Dose: Observed Maximum Serum Concentration (Cmax)|The concentration of MEDI-575 quantitatively determined in serum samples using a validated electrochemiluminescence (ECL) PK assay. The Cmax after the first dose was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI-575.|For 0.5/3, 6, 9, 12, 15 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3 and 8 (pre-dose); For 25 and 35 mg/kg: Cycle 1: Day 1 (pre- and end of infusion, 2 and 6 hours post infusion), Days 2, 3, 8 and 15.|All the participants who received first dose of MEDI-575 and for whom PK blood samples were collected and evaluated.|||Micrograms per milliliter (μg/mL)||Standard Deviation|Mean
1454683|NCT00815685|Secondary|Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%.|There is no expected range for “normal” activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA.|6 weeks per patient|Participants with available pre and post-treatment serum samples.|||Participants|||Number
1454656|NCT00816400|Primary|Maximum Tolerated Dose (MTD)|For the dose escalation phase, a minimum of 21 evaluable participants (3 participants each in Dose Cohorts 1 through 7) were required for this study if Dose Limiting Toxicities (DLTs) do not occur. If a DLT does occur among the first 3 participants in a cohort, 3 additional participants were to be added to the cohort; 3 more participants were to be added to a cohort to determine the MTD if only 3 participants have been previously treated at that dose. The MTD is the maximum dose at which no more than 1 out of 6 participants experienced a DLT. A DLT is defined as any grade 3 or higher hematologic toxicity or any grade 3 or higher non-hematologic toxicity except grade 3 fever (in the absence of neutropenia) or grade 3 rigors/chills.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|MTD evaluable population includes all participants in the dose escalation phase who have received at least 1 full cycle of MEDI-575 and have completed the safety follow-up through the DLT-evaluation period, or who experienced a DLT. The MTD dose was not evaluated as there were no DLTs reported in this study.|||Milligrams per kilogram (mg/kg)|||Number
1454657|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Vital Sign Parameters|Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
1454658|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|All 12-lead electrocardiograms (ECGs) performed during the study were obtained in triplicate (ie, 3 ECGs were obtained within a 5-minute time interval) and analyzed. ECG parameters included heart rate (high and low), QT interval, QTcB (corrected QT interval per Bazett's formula), and QTcF (corrected QT interval per Fridericia's formula). Number of participants with TEAEs related to ECG after the start of study drug were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
1454659|NCT00816400|Primary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (complete blood count, differential, and platelet count); serum chemistry (SrChem) aspartate transaminase (AST), alanine transaminase, total bilirubin, creatinine, alkaline phosphatase, sodium, potassium, chloride, phosphorus, calcium, glucose, magnesium, albumin, and lactate dehydrogenase); and routine urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
1454660|NCT00816400|Primary|Number of Participants With Serious Adverse Events|A serious AE (SAE) is any AE that results in death, is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs that emerged after start of study drug were reported. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The SAEs were summarized using MedDRA version 14.1.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population|||Participants|||Number
1454661|NCT00816400|Primary|Number of Participants With Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) are events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. Participants were counted only once for each event and by the highest event severity, regardless of how many events the participant experienced. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 14.1.|From the start of study drug administration through 30 days after last dose of MEDI-575, up to 112 weeks|Safety population: All participants who have received any treatment of MEDI-575|||Participants|||Number
1454662|NCT00816348|Primary|Level of Bilirubin|measurement of bilirubin level weekly. Available data reported.|week 2, 3,4,and 8||||mg/dL||Standard Deviation|Mean
1454663|NCT00816166|Primary|Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months|"The primary effectiveness endpoint was a composite of the two following outcomes:~Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization~Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization~A subject was deemed to be a primary endpoint success if neither of these outcomes occurred.~The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months)."|One Year|Analyses were based on an intent-to-treat (ITT) population, defined as enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and Medical Therapy Group subjects were analyzed according to their ITT randomized group regardless of treatment received.|||percent probability||95% Confidence Interval|Number
1454664|NCT00816101|Secondary|Erythema at Week 3|"At each weekly follow up visit, wound erythema was evaluated by the clinician on a scale of 0-4, with 0 being No erythema, 1 being Very slight erythema, 2 being Well defined erythema, 3 being Moderate to severe erythema and 4 being Severe erythema to slight eschar formation"|3 Weeks||||Erythema Scores on a Scale||Standard Deviation|Mean
1454665|NCT00816101|Secondary|Number of Patients Reporting Pain|Participants recorded their subjective pain level on a 0-10 Numeric Pain Chart 3x/day (0=no pain, 10=worst pain imaginable), until they had no pain for 3 consecutive days. Participants were also given a Patient Medication Log to complete at home to record RX and OTC medication they took to relieve pain. They were instructed to write the medication name, dosage, and amount of pills they took, as well as time taken, every day they took pain medication. Participants reporting pain had an associated score.|3 Weeks||||Participants|||Number
1454667|NCT00816062|Primary|Freedom From Aneurysm-related Mortality (ARM)|ARM is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness.|5 year Kaplan Meier (KM)|All enrolled subjects.|||Proportion of participants||95% Confidence Interval|Number
1454668|NCT00816036|Secondary|Prescription of Recommended Pharmacotherapy for Smoking Cessation||Assessed within 72 hours of hospital discharge||||participants|||Number
1454669|NCT00816036|Secondary|Referrals to Quitline||Assessed within 72 hours of hospital discharge||||participants|||Number
1454670|NCT00816036|Primary|7-day Point-prevalence Smoking Abstinence (6-month)|This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.|6 months post enrollment|This is the total number of subjects who completed 6 month follow-up (complete case analysis).|||participants|||Number
1454671|NCT00816023|Secondary|Treatment-emergent Adverse Events||Over the duration of the study.|Analysis conducted on Safety population, defined as all subjects randomized and received any study drug. Treatment groups are based on actual treatment received.|||participants|||Number
1454672|NCT00816023|Primary|Cumulative Volume of Packed Red Blood Cells Transfused at 12 Hours Post Surgery||Start of surgery up to 12 hours after the end of surgery|The Modified Intent to Treat population was the basis of this analysis, defined as all randomized subjects who received any amount of study drug and analyzed according to the planned treatment assignment.|||mL||Standard Deviation|Mean
1454673|NCT00815919|Secondary|Overall and cGVHD Progression-free Survival by 1 Year After Therapy||2 years||||percentage of participants||95% Confidence Interval|Number
1454674|NCT00815919|Secondary|Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy|Participants who were still being followed 1 year after the start of therapy had their prednisone dose recorded.|1 year after the start of study treatment|Participants who were still being followed 1 year after the start of therapy.|||participants|||Number
1454675|NCT00815919|Secondary|The Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|Participants' toxicities were graded based on the CTCAE version 3.0. The toxicities were then given an attribution to the velcade treatment: unrelated, unlikely, possible, probable, definite.|Toxicities were collected from the start of treatment through 15 weeks of therapy or end of study treatmetn||||participants|||Number
1454676|NCT00815919|Secondary|Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|The participants' total daily steroid dose was recorded at baseline and after a 15 week course of treatment. Starting at a dose of 0.5-1 mg/kg, dose reduction of steroids was permitted after 1 cycle of therapy. The suggested taper was 10-25% every 1-2 weeks. .|After 15 weeks of bortezomib plus prednisone therapy|Of the overall 22 patients, 18 patients completed 3 cycles (15 weeks) of therapy|||participants|||Number
1454677|NCT00815919|Primary|Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD|"Participants had their cGVHD evaluated per NIH consensus criteria:~Complete response: resolution of all reversible manifestations of cGVHD.~Partial response: a decrease ≥ 1 point on a 3-point organ-specific scale or 2 points or more on a 10-point global scale without progression in any organ sites.~Stable disease: no evidence of cGVHD response without evidence of progressive cGVHD.~Progressive cGVHD: increase of ≥ 1 point on an organ-specific 3-point scale, addition of a new immunosuppressive agent prior to the completion of 15 weeks of combination therapy, or requirement an increase in the total daily dose of corticosteroids above a participant’s baseline corticosteroid dose during the 15-week combined treatment period.~Mixed response: a response in primary sites of cGVHD involvement but interval progressive cGVHD in other organs or sites.~Responses were not scored for oral or ocular cGVHD, since topical therapies were permitted during the study."|Patients had their cGVHD assessed at Baseline and at 15 weeks or end of therapy||||participants|||Number
1454678|NCT00815776|Secondary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Score at Three Months Post-Baseline (in a scale)|"The arm that includes 0 (Mouth Splint Group) is included in the Primary Outcome Measure."|||Units on a scale||Standard Deviation|Mean
1454679|NCT00815776|Primary|Number of Subjects With Adverse Events|Subjects were assessed for adverse events from the baseline visit through study completion (3 months post-baseline). Adverse events were categorized by the investigator for severity and relationship to treatment.|From Baseline through 3 months post-baseline visit.||||Participants|||Number
1454680|NCT00815776|Primary|Change From Baseline In Craniomandibular Index (CMI) Scores At 3 Months (In A Scale)|The Craniomandibular Index (CMI) is designed to provide a basis for evaluating the severity of Temporomandibular Disorder (TMD) signs and symptoms. The assessment involves asking questions related to the condition of Mandibular Movement, TMJ noise, and palpations of the extraoral muscle, neck muscle, TMJ capsule and intraoral muscle. The answers to all of the questions are combined to calculate a score from 0 to 1 in which 0 represents no TMD signs and symptoms and 1 represents the most severe TMD signs and symptoms.|Change from Baseline in Craniomandibular Index (CMI) Scores at 3 months (in a scale)|"The arm that includes 0 (Jaw Exercise) is reported in Seconary Outcome Measure Table."|||Units on a scale||Standard Deviation|Mean
1454681|NCT00815698|Secondary|Recurrence|recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.|12 months after surgery||||participants|||Number
1454682|NCT00815698|Primary|Pain, Numbness and Discomfort in the Groin|The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.|12 months after surgery||||participants|||Number
1454696|NCT00815659|Secondary|LDL-5 Level After 3 Months of Rosuvastatin Treatment|LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-5 levels of participants|||mg/mL||Standard Deviation|Mean
1454697|NCT00815659|Secondary|Basal LDL-5 Level|LDL-5 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-5 levels of participants|||mg/mL||Standard Deviation|Mean
1454698|NCT00815659|Secondary|LDL-4 Level After 3 Months of Rosuvastatin Treatment|LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF(Last Observation Carried Forward) LDL-4 levels of participants|||mg/mL||Standard Deviation|Mean
1454699|NCT00815659|Secondary|Basal LDL-4 Level|LDL-4 levels before (Visit 2-enrollment)|Baseline|Baseline LDL-4 levels of participants|||mg/mL||Standard Deviation|Mean
1454700|NCT00815659|Secondary|LDL-3 Level After 3 Months of Rosuvastatin Treatment|LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL-3 levels of participants|||mg/mL||Standard Deviation|Mean
1454701|NCT00815659|Secondary|Basal LDL-3 Level|LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls|Baseline|Baseline LDL-3 levels of participants|||mg/mL||Standard Deviation|Mean
1454702|NCT00815659|Secondary|High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment|hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants|||mg/mL||Standard Deviation|Mean
1454703|NCT00815659|Secondary|Basal High Sensitivity C-reactive Protein (Hs-CRP) Level|hs-CRP levels before (Visit 2-enrollment)|Baseline|Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants|||mg/mL||Standard Deviation|Mean
1454704|NCT00815659|Secondary|Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment|TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants|||pg/mL||Standard Deviation|Mean
1454705|NCT00815659|Secondary|Basal Tumor Necrosis Factor (TNF) Level|TNF levels before (Visit 2-enrollment)|Baseline|Baseline Basal Tumor Necrosis Factor (TNF) levels of participants|||pg/mL||Standard Deviation|Mean
1454706|NCT00815659|Secondary|Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment|IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-10 levels of participants|||pg/mL||Standard Deviation|Mean
1454707|NCT00815659|Secondary|Basal Interleukin 10 (IL-10) Level|IL-10 levels before (Visit 2-enrollment)|Baseline|Baseline IL-10 levels of participants|||pg/mL||Standard Deviation|Mean
1454708|NCT00815659|Secondary|Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment|IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-8 levels of participants|||pg/mL||Standard Deviation|Mean
1454709|NCT00815659|Secondary|Basal Interleukin 8 (IL-8) Level|IL-8 levels before (Visit 2-enrollment)|Baseline|Baseline IL-8 levels of participants|||pg/mL||Standard Deviation|Mean
1454710|NCT00815659|Secondary|Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment|IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-6 levels of participants|||pg/mL||Standard Deviation|Mean
1454711|NCT00815659|Secondary|Basal Interleukin 6 (IL-6) Level|IL-6 levels before (Visit 2-enrollment)|Baseline|Baseline IL-6 levels of participants|||pg/mL||Standard Deviation|Mean
1454712|NCT00815659|Secondary|Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment|IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) IL-1 levels of participants|||pg/mL||Standard Deviation|Mean
1454713|NCT00815659|Secondary|Basal Interleukin 1 (IL-1) Level|IL-1 levels before (Visit 2-enrollment)|Baseline|Baseline IL-1 levels of participants|||pg/mL||Standard Deviation|Mean
1454714|NCT00815659|Primary|Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|Non-HDL cholesterol target levels <130 mg/dL, calculated over patients with lipid measurement performed at both visits|||Participants|||Number
1454715|NCT00815659|Primary|Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment|3 months (from enrollment to last visit)|HDL cholesterol target levels for males >40 mg/dL, for females > 50 mg/dL, calculated over patients with lipid measurement performed at both visits|||Participants|||Number
1454716|NCT00815659|Primary|Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment|Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL|3 months (from enrollment to last visit)|LDL cholesterol levels < 100 mg/dL, calculated over patients with lipid measurement performed at both visits|||Participants|||Number
1454717|NCT00815659|Primary|Triglyceride Level After 3 Months of Rosuvastatin Treatment|Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) triglyceride levels of participants|||mg/dL||Standard Deviation|Mean
1454718|NCT00815659|Primary|Basal Triglyceride Level|Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline triglyceride levels of participants|||mg/dL||Standard Deviation|Mean
1454719|NCT00815659|Primary|Total Cholesterol Level After 3 Months of Rosuvastatin Treatment|Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) total cholesterol levels of participants|||mg/dL||Standard Deviation|Mean
1454720|NCT00815659|Primary|Basal Total Cholesterol Level|Baseline|Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline total cholesterol levels of participants|||mg/dL||Standard Deviation|Mean
1454721|NCT00815659|Primary|LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) LDL levels of participants|||mg/dL||Standard Deviation|Mean
1454722|NCT00815659|Primary|Basal LDL-cholesterol Level|LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline|Baseline LDL levels of participants|||mg/dL||Standard Deviation|Mean
1454723|NCT00815659|Primary|HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment|HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)|3 months (from enrollment to last visit)|LOCF (Last Observation Carried Forward) HDL levels of participants|||mg/dL||Standard Deviation|Mean
1454724|NCT00815659|Primary|Basal HDL-cholesterol Level|HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)|Baseline||||mg/dL||Standard Deviation|Mean
1454725|NCT00815633|Primary|Evidence of Skin Change - PRP Area and Severity Index (PASI)||wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24|study terminated before data collected||||||
1454726|NCT00815633|Primary|Evidence of Skin Change - Physician’s Global Assessment (PGA)||wks 1,2,3,4,5,6,7,8,9,10,11,12, 16,20,24|study terminated before data collected||||||
1454727|NCT00815516|Secondary|Plasma Micafungin Concentration||15 minutes post intravenous infusion (IV), 4-8 hours post IV and 15-24 hours post IV|The pharmacokinetics (PK) analysis set, including those infants who received any amount of study drug, have at least one study drug concentration, and have dosing and blood collection date and time data sufficient for inclusion in a population pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
1454728|NCT00815516|Secondary|Follow-up Status for Infants With End-organ Assessments|"End-organ dissemination was assessed through abdominal ultrasound and/or computed tomography (CT), echocardiogram, head imaging and retinal exam. Each specific finding, documented by 1 of these techniques, was evaluated as follows:~Improvement: Improvement in size, number or density of identified lesions. Complete response was not expected but may have been documented.~Stabilization: Minor improvement or no change in size, number or density of identified lesions.~Worsening: Increase in size or number of identified lesions."|Baseline and 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with end-organ assessments|||percentage of participants|||Number
1454729|NCT00815516|Secondary|Mycological Response One Week After Last Dose of Study Drug|"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site."|One week after the last dose of study drug (maximum of 49 days)|Full analysis set|||percentage of participants|||Number
1454730|NCT00815516|Secondary|Mycological Response at End of Study Drug Therapy|"Mycological response assessments were based on the following definitions and assessed by the DRP:~Eradication: Culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 h apart; for Candida meningitis and/or candiduria, 1 negative culture.~Persistence: Continued isolation or histological documentation from a normally sterile site."|End of study drug therapy; maximum of 42 days|Full analysis set|||percentage of participants|||Number
1454731|NCT00815516|Secondary|Clinical Response One Week After Last Dose of Study Drug|"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and one week after the last dose of study drug (maximum of 49 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline|||percentage of participants|||Number
1454732|NCT00815516|Secondary|Clinical Response at the End of Study Drug Therapy|"Clinical response assessments were based on the following definitions and assessed by the DRP:~Complete Response: Resolution of all attributable signs related to fungal infection, if present at baseline.~Partial Response: Improvement in attributable signs related to the fungal infection, if present at baseline.~Stabilization: Minor improvement or no change in attributable signs related to the fungal infection, if present at baseline, and infant continued on therapy without deterioration.~Progression: Deterioration in attributable signs related to the fungal infection, if present at baseline; or if death occurred presumably related to a fungal infection."|Baseline and end of study drug therapy; maximum of 42 days|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline|||percentage of participants|||Number
1454733|NCT00815516|Secondary|Time to Positive Clinical Response|"Time to a positive clinical response is defined as the time from the first dose to the day during the treatment period that a positive clinical response (defined as a complete response or partial response) is observed for the first time, assessed by the Investigator.~Complete Response is defined as the resolution of all attributable signs related to fungal infection, if present at baseline and Partial Response is defined as improvement in attributable signs related to the fungal infection, if present at baseline.~Infants without positive responses and who survived were censored at one day post the end of treatment. Infants without positive responses who died before completing the treatment period, or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set participants with clinical signs and symptoms related to the fungal Infection at Baseline|||days||95% Confidence Interval|Median
1454734|NCT00815516|Secondary|Percentage of Participants With Recurrent Fungal Infections|A recurrent infection is defined as a systemic fungal infection in an infant with eradication at the end of study drug therapy, who developed positive blood cultures or a mycologically confirmed deep-seated Candida infection, with the same species as the enrolling infection.|Up to 30 days after the last dose of study drug (maximum of 72 days)|Participants in the full analysis set with eradication at the end of study drug therapy.|||percentage of participants||95% Confidence Interval|Number
1454735|NCT00815516|Secondary|Percentage of Participants With Emergent Fungal Infections|"An emergent fungal infection is defined as~An invasive fungal infection which is detected at any time during the study that is a non-Candida organism, or~An invasive fungal infection which is detected during the treatment or post-treatment period with a Candida species identified other than those detected at Baseline. If this occurred within 96 hours of the first dose of study drug, the infection was considered part of the final diagnosis of enrolling infection and not an emergent infection."|Up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1454736|NCT00815516|Secondary|Fungal-free Survival One Week After Last Dose of Study Drug in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive one week after last dose of study drug with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|One week after the last dose of study drug (maximum of 49 days)|Participants in the full analysis set with end-organ dissemination|||percentage of participants||95% Confidence Interval|Number
1454737|NCT00815516|Secondary|Fungal-free Survival at End of Study Drug Therapy in Infants With End-organ Dissemination|Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at the end of study drug therapy with a mycological response of eradication based upon the DRP assessment and no requirement for alternative systemic antifungal therapy for continued treatment.|The end of study drug therapy; maximum of 42 days|Participants in the full analysis set with end-organ dissemination|||percentage of participants||95% Confidence Interval|Number
1454738|NCT00815516|Secondary|Time to Mycological Clearance of Invasive Candidiasis|"Time to mycological clearance of invasive candidiasis is defined as the time from first dose to the day of mycological eradication for baseline invasive candidiasis infection.~Eradication was defined as a culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for for Candida meningitis and/or candiduria, 1 negative culture.~Infants without eradication during the treatment period and who survived were censored at one day after the end of treatment. Infants without eradication who died before completing the treatment period or were lost to follow-up during the treatment were censored at their death or last contact day."|From first dose up to 30 days after the last dose of study drug (maximum of 72 days)|Full analysis set|||days||95% Confidence Interval|Median
1454739|NCT00815516|Primary|Fungal-free Survival|"Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment.~Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documented by 2 negative samples, drawn at least 24 hours apart, or for Candida meningitis and/or candiduria, 1 negative culture."|One week after the last dose of study drug (maximum of 49 days)|Full Analysis Set (all randomized infants who were administered any amount of study drug)|||percentage of participants||95% Confidence Interval|Number
1454740|NCT00815490|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.|||percentage saturation||Full Range|Mean
1454741|NCT00815360|Secondary|Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months||6 months||||units on a scale (microns)|Participants|95% Confidence Interval|Mean
1454742|NCT00815360|Primary|Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.||6 months|We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on UWFA.|||Letters of visual acuity on ETDRS chart|Participants|95% Confidence Interval|Mean
1454743|NCT00815347|Secondary|Asthma Control Test Questionnaire|Patient reported outcome minimum 5 (no symptoms) maximum 25 (severe symptoms)|end of each dosing period||||scores on a scale||Standard Deviation|Mean
1454744|NCT00815347|Other Pre-specified|Ability to Taper Systemic Steroids Among Those Patients Who Are on Systemic Steroids at Study Entry.||17 weeks|||||||
1454745|NCT00815347|Other Pre-specified|Requirement for Urgent Medical Care for Asthma.||17 weeks|||||||
1454746|NCT00815347|Other Pre-specified|Requirement for Escalation of Controller Medication.||17 weeks|||||||
1454747|NCT00815347|Secondary|Rescue Beta-agonist||end of each dosing period||||puffs of rescue inhaler||Standard Deviation|Mean
1454748|NCT00815347|Secondary|FEV1||end of dosing period||||liters||Standard Deviation|Mean
1454749|NCT00815347|Primary|Symptom Scores|Symptom score could range from a minimum of 7 (no symptoms) to 35 (severe symptoms)|Last 7 days of each dosing period||||score on a scale||Standard Deviation|Mean
1454750|NCT00815347|Primary|Peak Flow||last 7 days of each dosing period|Data not analyzed, study terminated early||||||
1454751|NCT00815347|Primary|Change in FEV1||1, 2, 4 hours after dosing||||liters||95% Confidence Interval|Mean
1454752|NCT00815308|Secondary|Number of Participants With K-ras Gene Mutation|DNA was extracted from tumor specimens.Screened for the presence of KRAS codon 12 and 13 mutations using a PCR clamping and melting curve technique. PCR amplification of the wild-type KRAS sequence was suppressed in this process by the incorporation in the reaction mix of a locked nucleic-acid oligomer16 spanning codons 12 and 13 of the KRAS gene. Post-PCR hybridization and melting curve analysis using fluorescently tagged oligonucleotides incorporated in the original PCR reaction permitted the identification and discrimination of distinct KRAS codon 12 and 13 missense mutations.|07/29/2010-09/30/2010||||participants|||Number
1454753|NCT00815308|Secondary|Participants With Progression Free Survival (PFS)||Recurrence or metastasis from the date of diagnosis||2013-08-31|08/2013||||
1454754|NCT00815308|Secondary|Participants With Overall Survival (OS) at 3 Year||3 year from the date of diagnosis||2013-08-31|08/2013||||
1454755|NCT00815308|Secondary|Participants With Overall Survival (OS) at 1 Year||1 year from the date of diagnosis||2011-08-31|08/2011||||
1454756|NCT00815308|Secondary|Number of Participants With Toxicity|All patients were regularly monitored for possible adverse events, which were graded according to National Cancer Institute Common Toxicity Criteria version 3.0.|Every week during treatment and 1 month after therapy||||participants|||Number
1454757|NCT00815308|Primary|Number of Participants With Overall Response Rate (RR)|The overall response rate was defined as the numbers of patients with a complete response (CR) or partial response (PR). CR was defined as no target lesion at follow-up computed tomography scan and barium swallow examination 3–6 weeks after completion of chemo-radiation. PR was defined at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|1 to 3 month after therapy||||participants|||Number
1454758|NCT00815295|Secondary|Phase 2 - Mean Change From Baseline in Quality of Life - Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)|The outcome measure is the mean change in the Trial Outcome Index (TOI) between baseline and each follow-up assessment measured by the FACT-H&N. The instrument consists of 39 items to assess physical (PWB), social and family (SWB), emotional (EWB), functional well-bing (FWB) and additional head and neck specific concerns (HNCS). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. The TOI is the sum of PWB (7 items), FWB (7 items) and HNCS scores (12 items). TOI ranges from 0 to 140.|5 years|QOL data were not consistently collected and can not be analyzed.||||||
1454759|NCT00815295|Secondary|Median Progression-Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or death due to any cause. Per RECIST, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|5 years||||months||95% Confidence Interval|Number
1454760|NCT00815295|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|5 years|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.|||months||95% Confidence Interval|Number
1454761|NCT00815295|Primary|Tumor Control Rate|The proportion of patients for whom the best overall response is complete response (CR), partial response (PR) or stable disease (SD). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. If follow-up assessments are not available, the best overall response is unevaluable.|1 year|Patients assigned to receive 400 mg of Sorafenib within the phase I or II component of the study are included in the analysis. 4 patients who had a Cetuximab hypersensitivity reaction on day 1 and then terminated treatment are excluded from the analyses.|||percentage of participants||95% Confidence Interval|Number
1454762|NCT00815295|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Sorafenib Administered With Cetuximab (400 mg/m2 Loading Dose Followed by 250 mg/m2 Weekly)|The MTD is based upon dose-limiting (DLTs) experienced during Cycle 1 of treatment. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience DLT. Using Common Toxicity Criteria for Adverse EVents (CTCAE) version 3.0, DLTs are defined as any Grade 4 hematologic toxicity, or Grade 3 or 4 non-hematologic toxicity. A DLT will not be considered to have occurred in the case of a grade 3 or 4 allergic reaction due to cetuximab.|Cycle 1 (28 Days)|All patients treated on either dose level 1 or 2 as part of the phase I study.|||mg|||Number
1454763|NCT00815191|Primary|Intraoperative Distal Esophageal (Core) Temperature||at 1 hour||||°C||Standard Error|Mean
1454764|NCT00815087|Secondary|Questionnaire of Life Quality||1 to 3 months|||||||
1454765|NCT00815087|Primary|The Change From Baseline and Cut Point VFSS in Velocity of Displacement of Hyoid Bone at 1 to 3 Months|A parameter of the VFSS assessment was velocity of displacement of hyoid bone on 5mL thin barium sulfate bolus, which was defined as the displacement divided by the duration. The outcome measure time frame was based on VFSS assessment with the range between one to three months due to subjects received 1 to 3 times per week. We will provide the mean time frame, which is 2 months.|Averaged 2 months||||cm/s||Standard Deviation|Mean
1454766|NCT00815035|Secondary|Incidence of All Serious Adverse Events During the Study|All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome.|61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study.|The initial 10-11 months of the study were blinded. After unblinding, subjects completing the blinded phase continued on open label peanut OIT for the duration of the study.|||number of discrete SAE events|||Number
1454785|NCT00814970|Secondary|Procedure Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.|At time of deployment to time of hospital discharge|Intention-to-Treat (ITT)|||percentage of lesions treated|||Number
1454767|NCT00815035|Secondary|The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study|During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this.|approximately 40 weeks (10 months)|Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not re-escalate for the purposes of this outcome.|||percentage of patients|||Number
1454768|NCT00815035|Secondary|The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut|The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose.|first day of peanut OIT dosing|Open label phase includes subjects initially randomized to placebo and then subsequently crossed over to open label treatment. Subjects initially randomized to Peanut OIT maintained their dose and did not repeat this 6 mg initial-day escalation.|||percentage of participants|||Number
1454769|NCT00815035|Secondary|The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy.|Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy.|60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy|Subjects completing 60 months of OIT treatment and completing the DBPCFC on the last day of treatment were analyzed.|||percentage of participants|||Number
1454770|NCT00815035|Primary|Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.|Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.|61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy|Subjects completing 60 months of OIT treatment, then passing the DBPCFC on the last day of treatment, then completing the DBPCFC after 1 month off of treatment were analyzed.|||percentage of participants|||Number
1454771|NCT00814983|Secondary|Rate of Immune Recovery|The time to recovery of T-cell subset, B cell and NK cell recovery will be monitored along with T-Cell proliferative response to mitogens.|3 years|No analysis was performed since the experimental arm was not opened||||||
1454772|NCT00814983|Primary|Disease Free Survival||One year|No analysis was performed since the experimental arm was not opened||||||
1454773|NCT00814983|Primary|The Incidence of Grade II-IV Acute Graft Versus Host Disease||One year from date of transplant|No analysis was performed since the experimental arm was not opened||||||
1454774|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.|36 Months|Intention-to-Treat|||percentage of participants|Participants||Number
1454775|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.|36 Months|Intention-to-Treat|||percentage of participants|||Number
1454776|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.|24 Months|Intention-to-Treat (ITT)|||percentage of participants|Participants||Number
1454777|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.|24 Months|Intention-to-Treat|||percentage of participants|||Number
1454778|NCT00814970|Secondary|Clinically-driven Target Lesion Revascularization (TLR) Rate|Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
1454779|NCT00814970|Secondary|Percentage of Participants Free From Strut Fractures|Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.|12 Months|Intention-to-Treat (ITT)|||percentage of participants|Participants||Number
1454780|NCT00814970|Secondary|Change in Quality of Life - Decrease in Rutherford Class >= 1 Category|Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|30 Days|Intention-to-Treat (ITT)|||percentage of participants|||Number
1454781|NCT00814970|Secondary|Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15|Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
1454782|NCT00814970|Secondary|Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category|Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).|12 months|Intention-to-Treat (ITT)|||percentage of participants|||Number
1454786|NCT00814970|Secondary|Lesion Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)|||percentage of lesions treated|||Number
1454787|NCT00814970|Secondary|Device Success|The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).|Intention-to-Treat (ITT)|||percentage of lesions treated|||Number
1454788|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.|6 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
1454789|NCT00814970|Secondary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.|30 days|Intention-to-Treat (ITT)|||percentage of participants|||Number
1454790|NCT00814970|Primary|Primary Patency Rate|Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).|12 Months|Intention-to-Treat (ITT)|||percentage of participants|||Number
1454791|NCT00814970|Primary|Major Adverse Event (MAE) Rate|Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.|12 Months|Intent-to-Treat Population|||percentage of participants|||Number
1454792|NCT00814892|Secondary|Progression Free Survival (PFS)|PFS based on radiographic criteria was defined as the time from registration to the time of radiographic progression. A confirmed progression was defined as one for which radiological evidence of a new lesion is found following CT and/or bone scans.|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
1454793|NCT00814892|Secondary|Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire|"European Orgnisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 for cancer patients composed of 5 functional scales, 3 symptom scales, a global health status QOL scale, and six single items. Scores for each scale/item were calculated according to the questionnaire's scoring algorithm and range in 0 to 100, with high score represents high healthy level of functioning, high QOL or high level of symptomatology/problems. Change: Scores at cycle 1 minus scores at baseline.~Change from baseline in QOL will also be evaluated at cycle 6, 10, 15 and every 6 months during observation phase."|Baseline and cycle 1|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
1454794|NCT00814892|Secondary|Duration of PSA-based Response|"PSA-based response was defined as a PSA decline of at least 50%, which must be confirmed by a second PSA value in 4 or more weeks later.~The duration of PSA-based response are measured from the first time point at which the PSA has declined by at least 50% (which must eventually be confirmed by a second value) until PSA has increased back to 50% of the original on-study value."|Up to 3 years|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
1454795|NCT00814892|Secondary|Time to Prostate-specific Antigen (PSA) Progression|"In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline (on-study) and an increase in the absolute-value PSA level by at least 5 ng/mL, which is confirmed by a second value. In patients whose PSA has decreased but has not reached response criteria, progressive disease would be considered to have occurred when PSA increases 25% over the nadir, provided that the increase is a minimum of 5 ng/mL and is confirmed.~The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response). For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved (see above). All end dates require a confirmatory PSA."|Registration to PSA progression (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
1454796|NCT00814892|Secondary|Time to Prostate-cancer Specific Mortality||Registration to Prostate-cancer specific mortality (Up to 3 years)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
1454797|NCT00814892|Secondary|Number of Participants With Severe Adverse Events|Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.|Every cycle during treatment (up to 14 cycles)|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
1454798|NCT00814892|Primary|Number of Participants Who Are Progression Free at One Year|Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level <200.0 ng/mL.|One year|Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.||||||
1454799|NCT00814879|Secondary|Mean Change in Total Bilirubin (mg/dL) From Baseline|mean change in total bilirubin from baseline|baseline and 48 weeks||||mg/dL||Standard Deviation|Mean
1454800|NCT00814879|Secondary|Cholesterol|Total cholersterol (mg/dL)|baseline, week 24, week 48||||mg/dL||Standard Deviation|Mean
1454801|NCT00814879|Secondary|CD4+ Cell Count||Week 48||||cells/mm^3||Standard Deviation|Mean
1454802|NCT00814879|Secondary|CD4+ Cell Count||Weeks 24||||cells/mm^3||Standard Deviation|Mean
1454803|NCT00814879|Secondary|Number of Patients With < 400 Copies HIV RNA/mL at Week 48||48 weeks||||participants|||Number
1454804|NCT00814879|Primary|Number of Patients Reaching Virologic Failure at Week 48.|Virologic failure was defined by protocol as a plasma HIV RNA >50 c/mL on 2 consecutive occasions >7 days apart or > 10 000 c/mL on one occasion (in the absence of an intercurrent infection or recent immunization).|48 Weeks||||participants|||Number
1454805|NCT00814801|Secondary|Change From Baseline in the Mental Function Impairment Scale (MENFIS)|MENFIS is a Clinician's Interview-Based Impression of Change (CIBIC) plus-Japan subscale that rates the patient's severity for mental function impairment. This seven-point scale varies from 0 (= absolutely no impairment) to 6 (=complete impairment).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
1454806|NCT00814801|Secondary|Change From Baseline in the Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD)|Behave-AD is a CIBIC plus-J subscale that rates the patient's severity of psychotic symptoms. This four-point scale varies from 0 (=none) to 3 (= serious).|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
1454807|NCT00814801|Secondary|Change From Baseline in the Disability Assessment for Dementia (DAD)|Each of the 40 item of the DAD is scored as 1 point= Yes, 0 point= No, or non applicable= N/A. A total score (minimum=0; maximum=40) is the sum of points for each questions converted out 100. Items rated as Not Applicable (N/A) are not considered for the total score. The final score is a percentage that gives an appreciation of global function in activity of daily life (ADL). Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
1454808|NCT00814801|Primary|Distribution of Clinician's Interview-Based Impression of Change Plus - Japan (CIBIC Plus-J)|"CIBIC plus-J is the Japanese version of the Clinician's Interview-based Impression of Change plus the caregiver's input (CIBIC plus). It is a seven-point categorical assessment scale for evaluating the efficacy of antidementia drugs, ranging from markedly improved” to “markedly worse”."|24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||patients|||Number
1454809|NCT00814801|Primary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|ADAS-J cog is the Japanese version of the cognitive function subscale of the Alzheimer's disease assessment scale (ADAS). This scale is used to detect changes in cognitive function in individuals with Alzheimer disease on the basis of three domains: memory, language and behavior. The minimum score is zero (0) and means well cognitive function. The maximum total score is 70 points, and the larger the score, the more severe the degree of impairment.|Baseline and 24 weeks|Intent-to-treat (ITT) population. Last observation carried forward (LOCF) end point.|||Scores on a scale||Standard Deviation|Mean
1454810|NCT00814788|Secondary|Overall Survival|Overall survival was estimated using the Kaplan-Meier method.|Up to 3 years||||months||95% Confidence Interval|Median
1454811|NCT00814788|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years||||months||95% Confidence Interval|Median
1454812|NCT00814788|Primary|PSA Response Rate|The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.|Up to 2 years||||Participants|||Count of Participants
1454813|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy||60 seconds||||seconds||Inter-Quartile Range|Median
1454814|NCT00814775|Primary|To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy||from start of intubation to successfully intubated||||seconds||Inter-Quartile Range|Median
1454815|NCT00814710|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following first vaccination (Month 0) throughout the entire study period (month 3)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1454816|NCT00814710|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms"|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||subjects|||Number
1454817|NCT00814710|Secondary|Number of Subjects With Solicited Local and General Symptoms|Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. However, the total number of subjects analyzed in this Total Vaccinated cohort included all subjects having returned their symptom sheets.|||subjects|||Number
1454818|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)|Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
1454819|NCT00814710|Secondary|Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)|"Seroprotection was defined as:~Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
1454820|NCT00814710|Secondary|Number of Subjects Seropostive for B. Pertussis|Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
1454821|NCT00814710|Secondary|Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).|Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||mIU/mL||95% Confidence Interval|Geometric Mean
1454822|NCT00814710|Secondary|Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)|Concentration was expressed as GMC in EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1454823|NCT00814710|Secondary|Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)|Concentrations were expressed as GMCs in international units per milliliter (IU/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||IU/mL||95% Confidence Interval|Geometric Mean
1454824|NCT00814710|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentration is expressed as GMC in µg/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||µg/mL||95% Confidence Interval|Geometric Mean
1454825|NCT00814710|Secondary|Number of Subjects Seropositive for Protein D (PD)|Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
1454826|NCT00814710|Secondary|Number of Subjects Seropositive for Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.~Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL"|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
1454827|NCT00814710|Secondary|Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes|Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||µg/mL||95% Confidence Interval|Geometric Mean
1454828|NCT00814710|Secondary|Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.~The cut-off was defined as 0.20 microgram per milliliter (µg/mL)."|One month after primary immunization|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
1454829|NCT00814710|Secondary|Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.~Cross-reactive pneumococcal serotypes included 6A and 19A.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||subjects|||Number
1454830|NCT00814710|Primary|Concentration of Antibody Against Protein D (PD)|Concentrations were expressed as GMCs GSK’s 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1454831|NCT00814710|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes|"Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).~Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 3)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.|||µg/mL||95% Confidence Interval|Geometric Mean
1454832|NCT00814697|Primary|Cognitive Assessment Task Scores Before, During and After rTMS.|"Cognitive assessment tasks - Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), Mini-Mental State Examination (MMSE) - were administered and scored according to standard procedures before, during and 4 weeks after rTMS.~Higher scores are associated with better cognition; No absolute cut-offs were used here as the outcomes were not categorically assessed.~Total possible score ranges by test, lowest to highest:~BDAE - 0 to 15 CFL - 0 to 62 MMSE - 0 to 30 Full range data and means presented below represents range of scores at 4-weeks post-rTMS treatments."|6 weeks||||units on a scale||Full Range|Mean
1454833|NCT00814671|Secondary|Pharmacokinetics of Rifapentine|area under the concentration time curve (AUC[0-24]) for rifapentine administered once daily at doses of 450 mg or 600 mg in the context of multi drug intensive phase TB treatment|8 weeks||||ug x h/ml||Inter-Quartile Range|Median
1454834|NCT00814671|Secondary|Time to Stable Culture Conversion on Liquid MGIT Media|Time (in days) to stable culture conversion on liquid MGIT media|12 weeks||||days||Inter-Quartile Range|Median
1454835|NCT00814671|Secondary|Time to Stable Culture Conversion on Solid Medium|Time to stable culture conversion (in days) on Lowenstein Jensen solid medium|12 weeks|Data was not collected on some participants due to loss to follow up|||days||Inter-Quartile Range|Median
1454836|NCT00814671|Primary|Tolerability|percentage of participants discontinuing assigned treatment|10 weeks|safety analysis population|||percentage of participants|||Number
1454837|NCT00814671|Primary|Percentage of Participants With Negative Lowenstein Jensen Cultures at Week 8||8 weeks|per protocol|||percentage of participants w/LJ cx con|||Number
1454838|NCT00814658|Secondary|The Neuropsychiatric Inventory (NPI) at Baseline, Week 8, and Week 24|The NPI evaluates 12 neuropsychiatric domains: delusions, hallucinations, dysphoria, anxiety, aggression, euphoria, dis-inhibition, irritability/lability, apathy, aberrant motor activity, eating disorders, and night-time behavior disturbances. For present domains, the severity and frequency of the behavior are determined. Frequency is rated 1 (rarely) to 4 (very often) and Severity is scored 1 (mild) to 3 (severe). The product scores vary from 1 (mild and rarely) to 12 (very often and severe). Total scores vary from 0 (no present domain) to 144 (all domains are present, are often and severe).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1454839|NCT00814658|Secondary|The Clinical Global Impression (CGI) at Week 4, Week 8, Week 16, and Week 24|The Clinical Global Impression (CGI) is a scale to assess treatment response in patients with mental disorders. The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Week 4, Week 8, Week 16, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||participants|||Number
1454840|NCT00814658|Secondary|The Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) at Baseline, Week 8, and Week 24|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation and praxis using an 11-point Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1454841|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer’s Disease (QoL- AD) Total Scores, Based on the Caregiver's Opinion, at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer’s disease (QoL-AD), according to the opinion of the caregiver is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the opinion of the caregiver about the patient's quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1454842|NCT00814658|Primary|The Quality of Life Assessment for Patients With Alzheimer’s Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for patients with Alzheimer’s disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1454843|NCT00814658|Primary|The Quality of Life Assessment for Caregivers of Patients With Alzheimer’s Disease (QoL- AD) Total Scores at Baseline, Week 8, Week 24|The Quality of Life assessment scale for caregivers of patients with Alzheimer’s disease (QoL-AD) is a 13-item scale with four possible scores for each question (score 1: poor and score 4: excellent). It evaluates the caregivers own perceived quality of life. Total score ranges from 13 to 52. Higher scores represent a better outcome.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
1454844|NCT00814658|Primary|Reaction Time for Word Recognition and Learning Test at Baseline, Week 8, and Week 24|The reaction time for word recognition and learning test is a computerized attention test that evaluates the patient’s reaction time. This test is similar to the Face Recognition test procedure using Words. The recognition procedure was repeated three times to evaluate a learning effect. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
1454845|NCT00814658|Primary|Reaction Time for Face Recognition Test at Baseline, Week 8, and Week 24|The face recognition test is a computerized attention test in which ten unfamiliar faces were presented simultaneously on the computer screen for ten seconds to be remembered. After that, a single face was shown and the patient had to press the button one if he/she remembered or, otherwise, button five. It consisted of a random presentation of ten pre-exposed faces and ten new faces as distracters. The reaction time, assessed per patient, was averaged at each time point for each patient e.g., at baseline, Weeks 8 and 24. This test is part of the Computerized Neuropsychological Test Battery.|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
1454846|NCT00814658|Primary|Reaction Time for Two-choice Reaction Time Test at Baseline, Week 8, and Week 24|The Two-choice reaction time test is a computerized attention test in which the numbers one or five were presented in the center of the computer screen in a random order. The patient had to press the correspondent button in the response box as quickly as possible. The patient’s right finger was put over the button five and the left finger over button one before the test begun. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24.This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
1454847|NCT00814658|Primary|Reaction Time for Simple Reaction Time Test at Baseline, Week 8, and Week 24|The Simple Reaction Time is a computerized attention test that evaluates the patient’s reaction time. The number one was presented in the center of the computer screen and the patient had to press this number in the response box as quickly as possible. The reaction time, assessed 100 times per patient, was averaged at each time point for each patient e.g., at baseline, Week 8 and Week 24. The patient’s finger was put over button one before the test begun. This test is part of the Computerized Neuropsychological Test Battery (CNTB).|Baseline, Week 8, Week 24|Intent to Treat population, which consisted of all participants who used at least 1 study medication dose, had at least 1 evaluation after started use, and with evaluable data at each measurement time point.|||milliseconds||Standard Deviation|Mean
1454848|NCT00814632|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms. The GRA is a 7-point scale the allows the subject to respond to the question: As compared to when you started the study, overall how do you feel? The responses are: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.~The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks||||participants|||Number
1454849|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454850|NCT00814580|Secondary|Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454851|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454852|NCT00814580|Secondary|Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454853|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454854|NCT00814580|Secondary|Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454855|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454856|NCT00814580|Secondary|Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454857|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454858|NCT00814580|Secondary|Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454859|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454860|NCT00814580|Secondary|Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454861|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454862|NCT00814580|Secondary|Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)|"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)."|Baseline and 7 Days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).|||participants|||Number
1454863|NCT00814580|Secondary|Summary of Medical Resource Utilization – Number of Other Types of Contacts With Healthcare Professionals|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population|||Number of participants|||Number
1454864|NCT00814580|Secondary|Summary of Medical Resource Utilization – Number of Calls by the Subject to Study Site Personnel|Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.|7 Days|Intent-to-Treat Population|||Number of calls|||Number
1454865|NCT00814580|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population|||percentage of participants|||Number
1454866|NCT00814580|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|7 Days|Intent-to-Treat Population|||percentage of participants|||Number
1454867|NCT00814580|Secondary|Subject Satisfaction With Treatment|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied|7 Days|Intent-to-Treat Population|||percentage of participants|||Number
1454868|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454869|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454870|NCT00814580|Secondary|Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454871|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454872|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454873|NCT00814580|Secondary|Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454909|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.~Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
1454874|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief.|7 Days|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454875|NCT00814580|Secondary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454876|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 7|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population|||percentage of participants|||Number
1454877|NCT00814580|Secondary|Summary of 50% Responder Rate (With Imputation) on Day 3|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population|||percentage of participants|||Number
1454878|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 7|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.|Day 7|Modified Intent-to-Treat Population|||percentage of participants|||Number
1454879|NCT00814580|Secondary|Summary of 30% Responder Rate (With Imputation) on Day 3|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward.|Day 3|Modified Intent-to-Treat Population|||percentage of participants|||Number
1454880|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population|||Hours||95% Confidence Interval|Median
1454881|NCT00814580|Secondary|Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline|From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.|7 Days|Modified Intent-to-Treat Population|||Hours||95% Confidence Interval|Median
1454882|NCT00814580|Primary|Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score >= 4 on an 11-point numeric rating scale (NRS).|||Scores on a scale||Standard Deviation|Mean
1454883|NCT00814502|Secondary|Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms|"Rating Scale for Aggressive Behavior in the Elderly (RAGE, 0-61); higher is worse.~Disruptive Behavior Rating Scales (DBRS, 0-105); higher is worse.~Neuropsychiatric Inventory (NPI, 0-144) – measures 12 different domains of neuropsychiatric symptoms such as delusions, hallucinations, anxiety, depression, apathy, etc.; higher is worse.~Montgomery-Asberg Depression Rating Scale (MADRS, 0-90); higher is worse.~Mini-mental state examination (MMSE, 0-30); higher is better.~The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the firs"|post-intervention, up to 3 weeks||||units on a scale||Standard Error|Least Squares Mean
1454884|NCT00814502|Primary|Sleep Minutes|"Total sleep minutes during the down period. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep.~The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data."|post-intervention, up to 3 weeks||||sleep minutes||Standard Error|Least Squares Mean
1454885|NCT00814502|Primary|Sleep Efficiency|"Sleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100*sleep minutes)/[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)].~The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data."|Post-intervention, up to 3 weeks||||percentage of sleep (see above)||Standard Error|Least Squares Mean
1454886|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.|"The mean number was calculated for CD8+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) and pneumolysin toxoid (dPly) and expressing the following citokine combinations:~C1= at least interleukin 2 (IL2), tumor necrosis factor alpha (TNFa) and/or interferon-gamma (IFNg) and C2= at least interleukin 17 (IL17)."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.|||T-cells/million cells||Standard Deviation|Mean
1454887|NCT00814489|Secondary|Mean Number of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.|"The mean number was calculated for CD4+ cells stimulated by protein D (PD), pneumococcal histidine triad D (PhtD) or pneumolysin toxoid (dPly), identified as producing T-lymphocyte Helper 1 cells (Th1) versus Th2 cytokines (interferon-gamma (IFN-g) and interleukin-13 (IL-13) respectively, as measured by intracellular staining (ICS) on Peripheral Blood Mononuclear Cells (PBMCs). The outcome presents results for cells producing the following combinations:~Th1=IFN-g, Th 2=IL13 and/or IL5 and Th17=IL17."|Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.|||T-cells/million cells||Standard Deviation|Mean
1454888|NCT00814489|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD), Pneumolysin (Anti-Ply) and Pneumococcal Histidine Triad D (Anti-PhtD)|Concentrations were given as Geometric Mean Concentrations (GMCs). The cut-off values were 112 Luminex Units per milliliter (LU/mL) for Anti-PD, 391 LU/mL for Anti-PhtD and 591 LU/mL for Anti-Ply.|Days 0, 30, 60, 90, 180 and 420.|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received at least one dose of study vaccine/comparator and for whom data concerning immunogenicity measures were available.|||LU/mL||95% Confidence Interval|Geometric Mean
1454889|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON)), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.~This outcome presents results for BAS, NEU, LYM, EOS and MON. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
1454890|NCT00814489|Primary|Number of Subjects With Any Hematological Laboratory Abnormalities|"Hematological parameters assessed in blood samples include red blood cells (RBC), white blood cells (WBC - including Basophils (BAS), neutrophils (NEU), lymphocytes (LYM), eosinophils (EOS) and monocytes (MON), blood platelets (PLA) and Hemoglobin (HEM). Abnormalities reported include values outside the normal ranges.~This outcome presents results for RBC, WBC High and Low, PLA and HEM. Time points were presented as before (pre) or after (post) doses 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
1454891|NCT00814489|Primary|Number of Subjects With Any Biochemical Laboratory Abnormalities|"Biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA) and urea (URE).~Abnormalities reported include values outside the normal ranges. Time points were presented as before (Pre) or after (Post) Dose 1, 2 or 3."|During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
1454892|NCT00814489|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 420|The analysis was based on the Total Vaccinated Cohort, which included subjects with at least one study vaccine administration documented.|||Subjects|||Number
1455051|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
1454893|NCT00814489|Primary|Number of Subjects With Any Unsolicited Adverse Events (AE)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event."|During a 30-day (Days 0-29) follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
1454894|NCT00814489|Primary|Number of Subjects With Any Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom was defined as occurrence of any solicited local symptom regardless of intensity grade.~Solicited general symptoms assessed were fatigue, gastrointestinal, headache, malaise, myalgia and temperature Any temperature was defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C). For other symptoms: Any = any general symptom reported irrespective of intensity grade and relationship to vaccination."|During a 7-day follow up period after any vaccination|The analysis was based on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.|||Subjects|||Number
1454895|NCT00814463|Secondary|Overall Survival||12 months|||||||
1454896|NCT00814463|Secondary|Rate of Death Due to Neurologic Causes||12 months|||||||
1454897|NCT00814463|Secondary|Clinical Significance (if Any) of Locally Recurrent Brain Metastasis at the Time of Their Occurrence (Mass Effect, Cognitive Functioning, and Other Symptoms)||12 months|||||||
1454898|NCT00814463|Secondary|Preservation of Neurocognitive Function as Measured by the Mini-Mental State Exam||Every 3 months for 12 months.|||||||
1454899|NCT00814463|Secondary|Quality of Life as Measured by the FACT-Br Subscales||Every 3 months for 12 months|||||||
1454900|NCT00814463|Secondary|Rate of New Brain Metastases Outside of the Adjuvant SRS Site||12 months|||||||
1454901|NCT00814463|Secondary|Rate of Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery||12 months|||||||
1454902|NCT00814463|Primary|Recurrence Rate at the Surgical Site as Measured by MRI|The number of months for local recurrence via MRI|12 months||||Months|||Number
1454903|NCT00814346|Secondary|Change in Brain Morphology in the MC and CNE Groups as Determined by the Change in Voxel Size|Evolution of brain morphology (degree of cortical atrophy) after 18 months with EGb761, using MRI voxel based morphometry|From Baseline (Month 0) to Month 18|ITT population.|||mm3||Full Range|Median
1454904|NCT00814346|Secondary|Incidence of Adverse Events (AEs)|"The relationship of an adverse event to the study medication will be classified according to the following criteria:~Related : reports including good reasons and sufficient information (e.g. temporal relationship, dose-response relationship, pharmacology, positive de-challenge and/or re-challenge) to assume a causal relationship with the study drug in the sense that it is plausible, conceivable, or likely~Not related: reports including good reasons and sufficient information (e.g. no temporal relationship and/or attributable to concurrent disease or other drugs) to rule out a causal relationship with the study drug."|Up to Month 18|Safety population. CNE patients withdrew during the double-blind phase and were also not included in the safety population for open phase (17 months).|||participants|||Number
1454905|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 18|ITT population. N=Number of subjects with assessment.|||participants|||Number
1454906|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.|At Month 18|ITT population. N=Number of subjects with assessment.|||participants|||Number
1454907|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform TMT in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.~First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Seconds||Full Range|Median
1454908|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted WAIS in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.~Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
1454930|NCT00814346|Secondary|Change in Brain Glucose Metabolism in the MC and CNE Groups|"Brain glucose metabolism measured by 18FDG PET~SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]~BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80"|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||SUVBSA2||Full Range|Median
1454910|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of FCSRT|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.~Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.~Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.~Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Recall score||Full Range|Median
1454911|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.~The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Cube drawing test score||Full Range|Median
1454912|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Clock drawing test score||Full Range|Median
1454913|NCT00814346|Secondary|Change in Cognitive Tests-MMSE Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||MMSE Score||Full Range|Median
1454914|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.~Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.~Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||Number of good answers||Full Range|Median
1454915|NCT00814346|Secondary|Change in Cognitive Tests-GDS Score in MC and CNE Groups|The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By “yes” or “no” answers, scores permit to classify patients into groups of “severely depressed” (score of 21 to 30), “moderately depressed” (score of 11 to 20) and “normal” (score of 0 to10). It takes10 to 15 minutes to administer.|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||GDS Score||Full Range|Median
1454916|NCT00814346|Secondary|Change in Cognitive Tests-CDR Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3)|From Baseline (Month 0) to Month 18|ITT population. N=Number of subjects with assessment.|||CDR overall score||Full Range|Median
1454917|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to NINCDS-ADRDA (Diagnostic of Alzheimer’s)|The most widely accepted diagnostic criteria for probable AD are those offered by the National Institute of Neurological and Communicative Disorders and Stroke and by the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; McKhann et al., 1984). These criteria include the presence of dementia established by clinical examination and confirmed by neuropsychological testing. The dementia is described as involving multiple, progressive cognitive deficits in older persons in the absence of disturbances of consciousness, presence of psychoactive substances, or any other medical, neurological, or psychiatric conditions that might in and of themselves account for these progressive deficits.|At Month 9|ITT population. N=Number of subjects with assessment.|||participants|||Number
1454918|NCT00814346|Secondary|Number of Subjects Conversion to Alzheimer’s Dementia Diagnosed According to the DSM IV (Diagnostic of Dementia)|"The Diagnostic and Statistical Manual of Mental Disorders: 4th Edition of the American Psychiatric Association (DSM-IV, 1994) also outlines diagnostic criteria for dementia of the Alzheimer's type that are generally consistent with the NINCDS-ADRDA criteria.~National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA)"|At Month 9|ITT population. N=Number of subjects with assessment|||participants|||Number
1454919|NCT00814346|Secondary|Change in Cognitive Tests-Time to Perform Trail Making Test (TMT) in MC and CNE Groups|"TMT is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3,etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement.~First, in the TMT A, the subject has to connect numbers increasingly as fast as possible.~The TMT B requires the subject to connect and letters in an alternating pattern (1-A-2-B-3-C, etc.) in as little time as possible."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Seconds||Full Range|Median
1454931|NCT00814333|Primary|Cessation of Epistaxis||baseline, day 4-6|No participants started treatment on this study. Study was closed before any study related procedures were administered.||||||
1454920|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS) in MC and CNE Groups|"Wechsler Adult Intelligence Scale (WAIS) In this test subjects are asked to say how two seemingly dissimilar items might in fact be similar (14 item couples). This test involves especially abstract thinking and concept capacities.~Cognitive Tests-Age-Adjusted Wechsler Adult Intelligence Scale (WAIS): 19 tests on similarities. The items 1 to 5 are graded from 1 (good) to 0 (bad), and the items 6 to 19 are graded from 2 (good) to 0 (bad). Item 6 and 7 can be repeated. At the end, the worst total score is 0, the best total score is 33."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
1454921|NCT00814346|Secondary|Change in Cognitive Tests-Age-Adjusted Logical Memory (MEM III) in MC and CNE Groups|"Subjects are asked to memorize two short stories, one consisting of 24, the other one of 26 information units. After the stories have been read aloud by the investigator, subjects are asked to enounce all items of information they can remember (free recall). Correctly reported items are added for each story. This test applies analytical capacities, as well as auditive and verbal synthesis, working memory and episodic memory.~Score range from 0(worst) to 75 (better)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Age adjusted score||Full Range|Median
1454922|NCT00814346|Secondary|Change in Cognitive Tests in MC and CNE Groups - Total Immediate Recall and Delayed Recall Scores of the Free and Cued Selective Reminding Test (FCSRT)|"Free and Cued Selective Reminding Test (FCSRT) Assessment of verbal episodic memory. By this test performances in free recalls, cued recalls and in a recognition task can be analysed, because the process of encoding is controlled.~Subjects are asked to remember a list of 16 words. Three tasks of free and cued recalls, as well as one recognition task and one delayed recall give the scores.~Total recall is obtained by the addition of cued recalls to free recalls. Maximum score is 48 for immediate: 16 words X 3 corresponding to immediate free recall + immediate cued recall + immediate recognition test.~Maximum score is 64 (better score) when delayed recall : 16 words X 4 . The minimum score is 0 (worse)."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Recall score||Full Range|Median
1454923|NCT00814346|Secondary|Change in Cognitive Tests-Cube Drawing Test Score in MC and CNE Groups|"Cube drawing: Subjects are asked to draw a cube by heart. In case of failure, a model of a cube is given to the subjects to copy.~The score system ranges from 0 (worse score) to 6 (best score). Score calculation is following: 1 point by face with 4 sides, 2 points for each face where each angle should be respected."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Cube drawing test score||Full Range|Median
1454924|NCT00814346|Secondary|Change in Cognitive Tests-Clock Drawing Test Score in MC and CNE Groups|Clock drawing test is a visuo-constructive task, where subjects are asked to draw the face of a clock in a pre-drawn circle and then to draw in the arms to denote 16:45 (a quarter to five). The drawing can then be evaluated by a quantitative scoring method, which is based on the degree of completion of the drawing. The scoring system ranges from 0 to 6 with higher scores reflecting a greater number of errors and more impairment.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Clock drawing test score||Full Range|Median
1454925|NCT00814346|Secondary|Change in Cognitive Tests-Mini Mental Status Examination (MMSE) Score in MC and CNE Groups|MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, ability to name objects, follow verbal and written commands, write a sentence, and copy figures. Total score ranges from 0 to 30, with a lower score indicating greater disease severity.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||MMSE Score||Full Range|Median
1454926|NCT00814346|Primary|Change in Brain Glucose Metabolism Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET)|"Following statistical parametric mapping (SPM) analyses were performed by the Commissariat à l’Energie Atomique (CEA):~The comparison between treatment groups separately for each group of elderly subjects (CNE and MC groups only)~The comparison between the two groups of elderly subjects (CNE and MC groups only) by treatment group~FDG PET demonstrates reductions in the cerebral glucose metabolism that may occur a few years before the overt clinical manifestation of disease.~SUVBSA2 = [Brain radioactivity (Bq/cc)] / [Injected dose (MBq)/BSA2] x [Blood glucose (g/l)]~BSA2(m^2) = 0.007184 x Height (cm)^0.35 x weight (kg)^0.80~Standardized Uptake Value (SUV) Body Surface Area (BSA)"|From Baseline (Month 0) to Week 4 (Month 1) - Double blind phase|Intention to treat (ITT) population: All treated CNE and MC patients|||SUVBSA2||Full Range|Median
1454927|NCT00814346|Secondary|Change in Cognitive Tests-Verbal Fluency in MC and CNE Groups|"Subjects completed a verbal fluency test. Higher scores represent higher levels of verbal fluency. Minimum score=0 and Maximum score= N/A.~Letter fluency: this task consists of enouncing as many words as possible that begin with a given letter of the alphabet. Participants are not allowed to use proper names.~Categorical fluency: in this task participants are asked to list as many words as possible that belong to a given semantic category (e.g. animals, fruits, towns) Each condition foresees 60 sec of word generation time. The score corresponds to the number of words correctly given. The verbal fluency task measures semantic storage and executive retrieval functions."|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||Number of good answers||Full Range|Median
1454928|NCT00814346|Secondary|Change in Cognitive Tests-Geriatric Depression Scale (GDS) Score in MC and CNE Groups|The Geriatric Depression Scale is a self-administered depression scale, which was developed as a basic screening measure for depression in older adults. By “yes” or “no” answers, scores permit to classify patients into groups of “severely depressed” (score of 21 to 30), “moderately depressed” (score of 11 to 20) and “normal” (score of 0 to10). It takes10 to 15 minutes to administer.|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||GDS Score||Full Range|Median
1454929|NCT00814346|Secondary|Change in Cognitive Tests-Clinical Dementia Rating (CDR) Score in MC and CNE Groups|CDR is a structured interview to collect information regarding subject's memory in a standard way from both the patient and the helper. Scores are calculated using below scale; q CDR=No dementia (score: 0), q CDR=Very mild dementia (score: 0.5), q CDR=Mild dementia (score: 1), q CDR=Moderate dementia (score: 2) and q CDR=Severe dementia (score: 3).|From Baseline (Month 0) to Month 9|ITT population. N=Number of subjects with assessment.|||CDR overall score||Full Range|Median
1455052|NCT00814164|Secondary|Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
1454932|NCT00814320|Secondary|Percentage of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs’ test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)||||Percentage of participants|||Number
1454933|NCT00814320|Secondary|Number of Participants Who Experienced a Hemoglobin Drop of >2.0 g/dL, With Evidence of Hemolysis on Further Analysis|Further analysis for incidences of potential hemolysis included direct Coombs’ test, free hemoglobin, serum haptoglobin, LDH, urine hemosiderin and microscopic urinalysis|Throughout the study period (17 months)||||Number of participants|||Number
1454934|NCT00814320|Secondary|Percentage of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of participants|||Number
1454935|NCT00814320|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)||Throughout the study period (17 months)|Safety Analysis Data Set|||Number of participants|||Number
1454936|NCT00814320|Secondary|Median Rate of AEs Temporally Associated or Related to Study Drug Per Infusion|"Temporally associated defined as during infusion or within 72 hours of completion of infusion.~Related defined as determined by investigator to be at least possibly related to study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]).~Expressed as a percentage."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of AE|Infusions|95% Confidence Interval|Median
1454937|NCT00814320|Secondary|Percentage of Infusions Tolerated With IV and SC Administration at Dose Used in Study Epoch 2 (SC/rHuPH20 Treatment)|"Epoch 2: subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10% with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Dose used in Epoch 2 (after ramp-up) was 108% of dose used in intravenous (IV) administration of IGIV, 10%.~The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
1454938|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 AE Related to Either or Both Study Drugs|"Percentage of Infusions Associated With ≥1 AE Related to immune globulin intravenous (IGIV), 10%, [administered via intravenous (IV) or subcutaneous (SC) route], recombinant human hyaluronidase (rHuPH20) or both.~The percentage of affected infusions is calculated per subject and then summarized by the median of all subjects analysed."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
1454939|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant|||Number
1454940|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant|||Number
1454941|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Participant (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant|||Number
1454942|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); ; RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1454943|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1454944|NCT00814320|Secondary|Rate of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity Per Infusion (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions||Number
1454945|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (N-Z)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~Resp.-Respiratory WBC - White blood cells"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs|||Number
1454946|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (G-M)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs|||Number
1454947|NCT00814320|Secondary|Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to Study Drug, and Severity (A-F)|"Categories presented as Preferred term-Seriousness, Relatedness, Severity. The following codes are to be used:~Seriousness: non-SAE-non-serious AE; SAE-serious AE Relationship: NR-not related to immune globulin (IGIV), 10% and recombinant human hyaluronidase (rHuPH20); RIGIV-related to IGIV, 10%; RrHu-related to rHuPH20; Rboth-related to both IGIV, 10% and rHuPH20 Severity: Mild; Mod (Moderate); Severe~Preferred terms abbreviated:~ADHD-Attention Deficit/Hyperactivity Disorder BP-Blood Pressure COPD- Chronic Obstructive Pulmonary Disease"|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs|||Number
1454948|NCT00814320|Secondary|Frequency of Dose Corrections (If IgG Trough Levels <4.5 g/L) for Each Study Epoch (IV and SC/rHuPH20 Treatment)|Frequency of dose corrections based on immune globulin G (IgG) trough levels <4.5 g/L IgG, if any, for intravenous (IV) (Epoch 1) and subcutaneous with recombinant human hyaluronidase (SC/rHuPH20) after ramp-up (Epoch 2) administration of immune globulin intravenous (IGIV), 10% Defined/calculated as the number of participants requiring dose adjustments divided by the number of participants, for each respective data set.|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of participants|||Number
1454949|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Infusion|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of infusions|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per infusion|Infusions|95% Confidence Interval|Median
1454950|NCT00814320|Secondary|Rate of AEs Determined to be Related to the Study Drug by the Investigator Per Participant|Rate of related AEs defined as the total number of AEs determined by the investigator to be related to the study drug (immune globulin intravenous [IGIV], 10% or recombinant human hyaluronidase [rHuPH20]), that occur at any time during the study divided by the total number of participants|Throughout the study period (17 months)|Safety Analysis Data Set|||Number of AEs per participant||95% Confidence Interval|Median
1454951|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE At Any Time During the Study|Percentage of participants With ≥1 local AE (including and excluding infections) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up at any time during the study|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
1454952|NCT00814320|Secondary|Percentage of Participants With ≥1 Local AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants With ≥1 local AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
1454953|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE At Any Time During the Study|Percentage of intravenous (IV) and subcutaneous (SC) infusions with recombinant human hyaluronidase (rHuPH20) after ramp-up of immune globulin intravenous (IGIV), 10% associated with ≥1 local AE (including and excluding infections) at any time during the study|At any time during the study|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
1454954|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Local AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of IV and SC (with recombinant human hyaluronidase [rHuPH20]) infusions associated with ≥1 local AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with rHuPH20 after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
1454955|NCT00814320|Secondary|Percentage of Participants With ≥1 Systemic AE (Including and Excluding Infections) During Infusion or Within 72 Hours of Completion of Infusion|Percentage of participants with ≥1 systemic AE (including and excluding Infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Participants exposed to either or both study drugs|||Percentage of participants|||Number
1454956|NCT00814320|Secondary|Percentage of Infusions Associated With ≥1 Systemic AE During Infusion or Within 72 Hours of Completion of Infusion|Percentage of intravenous (IV) and subcutaneous (SC) infusions associated with ≥1 systemic AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via IV or SC route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
1454957|NCT00814320|Secondary|Percentage of SC Doses of IGIV, 10% and rHuPH20 Tolerated at 1 Infusion Site|"Percentage of subcutaneous (SC) doses of immune globulin intravenous (IGIV), 10% and recombinant human hyaluronidase (rHuPH20) tolerated at 1 infusion site.~An infusion was deemed as tolerated if there were no serious adverse drug reactions (ADRs), no non-serious moderate or severe local ADRs that prevented completion of the infusion, and no non-serious moderate or severe systemic ADRs during or within 60 minutes of completion of the infusion."|During infusion or within 60 minutes of completion of the infusion|Safety Analysis Data Set|||Percentage of infusions||95% Confidence Interval|Median
1454958|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated Moderate or Severe AEs Within 72 Hours of Completion of Infusion|"Percentage of infusions resulting in at least 1 moderate or severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions|95% Confidence Interval|Median
1454959|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated Moderate or Severe AEs|"Percentage of participants reporting at least 1 Moderate or Severe AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
1454960|NCT00814320|Secondary|Percentage of Infusions Resulting in ≥1 Temporally Associated AEs|"Percentage of infusions resulting in at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of infusions|Infusions||Number
1454961|NCT00814320|Secondary|Percentage of Participants Reporting ≥1 Temporally Associated AEs|"Percentage of participants reporting at least 1 AE (including and excluding infections) during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of infusion (temporally associated)"|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set|||Percentage of participants|||Number
1454962|NCT00814320|Secondary|Rate of Temporally Associated AEs Per Infusion|Rate of all AEs (including and excluding infections) per infusion that began during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up (during infusion) or within 72 hours of completion of an infusion (“temporally associated”)|During infusion or within 72 hours of completion of infusion|Safety Analysis Data Set (SADS)|||Number of AEs per infusion|Infusions|95% Confidence Interval|Median
1454963|NCT00814320|Secondary|Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).~IV administration of IGIV, 10%: 365 infusions; SC administration of IGIV, 10% with rHuPH20: 1129 infusions"|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of infusions|Infusions||Number
1454964|NCT00814320|Secondary|Percentage of Participants for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for Adverse Events (AEs)|"Percentage of participants for which the infusion rate was reduced and/or the infusion interrupted or stopped during administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up for tolerability concerns or for adverse events (AEs).~An infusion was deemed as tolerated if there are no serious Adverse Drug Reactions (ADR), no non-serious moderate or severe local ADRs that prevent completion of the infusion and no non-serious moderate or severe systemic ADRs during infusion or within 60 minutes of completion of the infusion."|Throughout the study period (17 months)|Safety Analysis Data Set|||Percentage of participants|||Number
1454965|NCT00814320|Secondary|Rate of Days in Hospital|"Monthly rate of days in hospital after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Days per month||95% Confidence Interval|Number
1454966|NCT00814320|Secondary|Rate of Acute Physician Visits|"Monthly rate of acute physician visits after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month will be defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Visits per month||95% Confidence Interval|Number
1454967|NCT00814320|Secondary|Rate of Days on Antibiotics|"Monthly rate of days on antibiotics after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month was defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Days on antibiotics per month||95% Confidence Interval|Number
1454968|NCT00814320|Secondary|Rate of Days Off School or Work|"Monthly rate of days off school or work after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the monthly rates were calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary outcome measures.~The lengths of the month were defined as average length of the month in the Gregorian calendar, namely (365*400+100-3)/(400*12)= 30.436875 days."|Monthly, for up to 17 months|Full Analysis Data Set|||Days off per month||95% Confidence Interval|Number
1454969|NCT00814320|Secondary|Time to Maximum H. Influenzae Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum influenza (haemophilus influenzae) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
1454970|NCT00814320|Secondary|H. Influenzae Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for influenza (haemophilus influenzae) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of influenza antibody in the body to be reduced by 50% during the terminal phase."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
1454971|NCT00814320|Secondary|H. Influenzae Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||μg/mL||95% Confidence Interval|Median
1454972|NCT00814320|Secondary|H. Influenzae Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||L/kg/day||95% Confidence Interval|Median
1454973|NCT00814320|Secondary|H. Influenzae Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Influenza (haemophilus influenzae) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||μg*days/mL||95% Confidence Interval|Median
1454974|NCT00814320|Secondary|H. Influenzae Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal influenza (haemophilus influenzae) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||μg/mL||95% Confidence Interval|Median
1455008|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||events||Standard Deviation|Mean
1454975|NCT00814320|Secondary|Time to Maximum Tetanus Antibody Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum tetanus (clostridium tetani toxoid) antibody Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
1454976|NCT00814320|Secondary|Tetanus Antibody Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||IU/mL||95% Confidence Interval|Median
1454977|NCT00814320|Secondary|Tetanus Antibody Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for tetanus (clostridium tetani toxoid) antibody after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of tetanus antibody in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
1454978|NCT00814320|Secondary|Tetanus Antibody Clearance (CL) for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance (CL) and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||nL/IU/day||95% Confidence Interval|Median
1454979|NCT00814320|Secondary|Tetanus Antibody Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Tetanus (clostridium tetani toxoid) antibody Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||IU*days/mL||95% Confidence Interval|Median
1454980|NCT00814320|Secondary|Tetanus Antibody Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal tetanus (clostridium tetani toxoid) antibody concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||IU/mL||95% Confidence Interval|Median
1454981|NCT00814320|Secondary|Time to Maximum IgG Concentration (T-max) for Participants Aged 12 Years and Older|Time to Maximum Immunoglobulin (IgG) Concentration (T-max) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
1455053|NCT00814164|Secondary|Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy||4 years|Due to the study's early termination and sponsor's withdrawal of support, data were not collected for this assessment.||||||
1454982|NCT00814320|Secondary|IgG Terminal Half Life (T1/2) for Participants Aged 12 Years and Older|"Terminal half life (T1/2) for immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Terminal half life is the time it takes for the plasma concentration or the amount of immunoglobulin in the body to be reduced by 50% during the terminal phase"|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Days||95% Confidence Interval|Median
1454983|NCT00814320|Secondary|IgG Maximum Plasma Concentration (C_max) for Participants Aged 12 Years and Older|Maximum immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||g/L||95% Confidence Interval|Median
1454984|NCT00814320|Secondary|IgG Clearance (CL) for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Clearance after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~Clearance (CL) is provided after administration of IGIV,10% given via IV route. Apparent Clearance is provided after administration of IGIV, 10% given via SC route with rHuPH20.~Clearance and apparent clearance are determined by weight adjusted dose divided by total AUC."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||mL/kg/day||95% Confidence Interval|Median
1454985|NCT00814320|Secondary|IgG Area Under the Curve (AUC)/Week for Participants Aged 12 Years and Older|"Immunoglobulin (IgG) Area under the Curve (AUC) AUC/week after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and older.~The AUC between adjacent infusions was calculated by the trapezoidal rule. Linear interpolation/extrapolation was used to calculate the AUC for the exact duration of the infusion intervals (21 days for 3-week treatment interval or 28 days for 4-week treatment interval)."|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion.|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||g*days/L||95% Confidence Interval|Median
1454986|NCT00814320|Secondary|IgG Minimum Plasma Concentration (C_min) for Participants Aged 12 Years and Older|Minimal immunoglobulin (IgG) concentration after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) for participants aged 12 years and Older|PK evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval]; SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with PK measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||g/L||95% Confidence Interval|Median
1454987|NCT00814320|Secondary|Antibody Levels to Hepatitis B|Antibody levels to hepatitis B after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results|||mIU/mL||95% Confidence Interval|Median
1454988|NCT00814320|Secondary|Antibody Levels to Measles|Antibody levels to measles after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in the Full Analysis Data Set with available specific antibody test results|||Titer||95% Confidence Interval|Median
1454989|NCT00814320|Secondary|Antibody Levels to Haemophilus Influenzae|Antibody levels to Haemophilus influenzae after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results|||μg/mL||95% Confidence Interval|Median
1455054|NCT00814164|Secondary|Overall Survival|Overall survival was defined as time from date of treatment initiation until date of death due to any cause.|4 years|All treated and eligible patients|||months||95% Confidence Interval|Median
1454990|NCT00814320|Secondary|Antibody Levels to Tetanus (Clostridium Tetani Toxoid)|Antibody levels to Tetanus (Clostridium tetani toxoid) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) at end of IV treatment and end of SC treatment with rHuPH20|IV: At baseline; SC/rHuPH20: at baseline then at infusion #1 at ramp-up and at infusions #5, 9, 13 (for 3-week treatment interval) and infusions #4, 7, 10 (for 4-week treatment interval), SC: end of SC treatment and at end of study visit|Participants in Full Analysis Data Set with available specific antibody test results|||IU/mL||95% Confidence Interval|Median
1454991|NCT00814320|Secondary|Trough Levels of IgG Subclasses After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) subclasses after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up by IgG subclasses 1 to 4 at end of IV treatment and end of SC treatment with rHuPH20 IgG subclass 1 (IgG 1) IgG subclass 2 (IgG 2) IgG subclass 3 (IgG 3) IgG subclass 4 (IgG 4)|IgG subclasses (1-4) trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp up for SC) and at end of study visit|Participants who have been exposed to either or both study drugs with available IgG subclass trough level measurements|||mg/dL||95% Confidence Interval|Median
1454992|NCT00814320|Secondary|Trough Levels of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20|Trough levels of immunoglobulin (IgG) after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for IV and SC (except during ramp up for SC) and at end of study visit.|Full Analysis Data Set|||g/L||95% Confidence Interval|Median
1454993|NCT00814320|Secondary|Annual Rate of All Infections Per Participant|"Annual rate of all infections per participant after administration of immune globulin intravenous (IGIV), 10% given via intravenous (IV) or subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up.~Point estimates and 95% CIs for the annual rates will be calculated using a Poisson model and the same methodology including allowance for over-dispersion as described for the primary endpoint."|Throughout the study period (17 months)|Full Analysis Data Set|||Estimated infections/year||95% Confidence Interval|Number
1454994|NCT00814320|Secondary|Bioavailability (AUC) of IgG After SC Administration of IGIV, 10%, Given With and Without rHuPH20|"Bioavailability of immunoglobulin (IgG) after subcutaneous (SC) administration of immune globulin intravenous (IGIV), 10%, with and without recombinant human hyaluronidase (rHuPH20) (from current study 160603 and study 160601, respectively), as measured by ratio of AUC of IgG per dose/kg with versus without rHuPH20.~Expressed as a percentage.~This was analysed for participants in Stratum A , participants in Stratum B and for all participants who received IGIV, 10% via SC administration (Stratum A plus Stratum B):~Stratum A: Participants who provided data both on SC with AND without rHuPH20 ie, participants who participated in both studies 160601 and 160603; Stratum B: Participants who provided data on SC with OR without rHuPH20, but not on both (participants who participated in study 160601 OR 160603, but not in both studies)."|PK: 160603 (IV: before infusion (inf.) #4 [3-week treatment interval] or inf. #3 [4-week treatment interval];SC: before last SC inf.) 1 hour pre-inf. ≤28 days (+/-2 days) post-inf.; 160601- 1 hour pre-inf. (before inf. #8) ≤7 days (+/-1 day) post-inf.|Participants in the Full Analysis Data Set aged ≥ 12 years from the current study (160603) and prior Baxter study 160601 who received IGIV, 10% via SC administration|||Percentage||90% Confidence Interval|Number
1454995|NCT00814320|Secondary|Bioavailability (Trough Levels) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants Aged 2 to < 12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of trough levels after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|IgG trough levels measured at baseline and on day of each 3- or 4-week infusion for infusion for IV and SC (except during ramp-up for SC) and at end of study visit|Participants aged 2 to < 12 years exposed to either or both study drugs with available IgG trough level measurements|||Percentage||95% Confidence Interval|Number
1454996|NCT00814320|Secondary|Bioavailability (AUC) of IgG After Administration of IGIV, 10% Given Via IV or SC With rHuPH20 in Participants ≥12 Years|Bioavailability expressed as pharmacokinetic (PK) equivalence of immunoglobulin (IgG) in terms of ratio of Area Under the Concentration Curve (AUC)/Week after administration of immune globulin intravenous (IGIV), 10% given via subcutaneous (SC) route with recombinant human hyaluronidase (rHuPH20) after ramp-up to intravenous (IV) route, i.e. ratio of AUC/week of SC/rHuPH20 versus IV administration of IGIV, 10%. Expressed as a percentage.|PK AUC evaluations: (IV: before infusion #4 [for 3-week treatment interval] or infusion #3 [for 4-week treatment interval];SC: before last SC infusion) 60 minutes pre-infusion up to 28 days (+/-2 days) post-infusion|"Participants ≥ 12 years exposed to either or both study drugs with AUC measurements at the following time points:~Pre-infusion and 30-minutes post-infusion (Day 0) IV- Days 1, 4, 9, 14, 21, 28* SC- Days 1, 3, 5, 9, 14, 21, 28*~*Measurements at Day 28 for the 4-week treatment interval only"|||Percentage||90% Confidence Interval|Number
1454997|NCT00814320|Primary|Validated Acute Serious Bacterial Infection (VASBI) Rate|"Serious acute bacterial infections include bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess that are caused by a recognized bacterial pathogen.~VASBI rate is the mean number of VASBIs per participant per year, recorded for SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only.~The mean number of VASBIs per participant per year and the 99% upper confidence limit for the acute serious bacterial infection rate were calculated using a Poisson model to account for the length of the observation periods per participant."|Throughout the study period (17 months)||||Estimated infections/year|||Number
1455009|NCT00814307|Secondary|Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||events||Standard Deviation|Mean
1454998|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Month 6|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each group respectively.|||units on a scale||Standard Deviation|Mean
1454999|NCT00814307|Secondary|Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455000|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
1455001|NCT00814307|Other Pre-specified|Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|2 weeks|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days|||Number
1455002|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1455003|NCT00814307|Secondary|Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3|Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455004|NCT00814307|Secondary|Number of Hours Per Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||hours per day||Standard Deviation|Mean
1455005|NCT00814307|Secondary|Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||hours per day||Standard Deviation|Mean
1455006|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Month 6|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||days||Standard Deviation|Mean
1455007|NCT00814307|Secondary|Number of Days as Assessed Using RA-HCRU at Baseline and Month 3|RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||days||Standard Deviation|Mean
1455055|NCT00814164|Secondary|Disease-free Survival|Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.|5 years|All treated and eligible patients who had first objective documentation of CR or CRp.|||months||95% Confidence Interval|Median
1455010|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455011|NCT00814307|Secondary|Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3|Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.|Baseline, Month 3|FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455012|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1455013|NCT00814307|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455014|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1455015|NCT00814307|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3|FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455016|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1455017|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Month 6|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Month 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1455018|NCT00814307|Secondary|Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3|MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.|Baseline, Month 3|FAS population. 'n'=participants evaluable at given time point for each group respectively.|||participants|||Number
1455019|NCT00814307|Secondary|Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3|Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455020|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Month 6|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1455021|NCT00814307|Secondary|36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455022|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
1455023|NCT00814307|Secondary|Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
1455024|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
1455025|NCT00814307|Secondary|Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly."|Baseline, Week 2, Month 1, 2, 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
1455026|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Month 4, 5 and 6|Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Month 4, 5, 6|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
1455027|NCT00814307|Secondary|Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.|Baseline, Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.|||mm||Standard Deviation|Mean
1455069|NCT00813982|Primary|Overall Vision|Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week|Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation.|||Units on a Scale||Standard Deviation|Mean
1455028|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455029|NCT00814307|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455030|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Month 4, 5, 6|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455031|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3|DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Week 2, Month 1, 2, 3|FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455032|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1455033|NCT00814307|Secondary|Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3|DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.|Baseline, Month 3|FAS population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1455034|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1455035|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3|ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1455047|NCT00814255|Primary|Number of Participants With a Reduction in Proteinuria at 6 Months by > 50% of the Value at Screening AND Stable GFR Defined as Greater Than 75 ml/Min/1.73m2 in Those With an Initial Value Above 90 OR Within 25% of Baseline for Remaining Patients|Number of participants with a reduction in proteinuria at 6 months by > 50% of the value at screening AND stable GFR defined as greater than 75 ml/min/1.73m2 in those with an initial value above 90 OR within 25% of baseline for remaining patients.|baseline and 6 months|One participant was assigned to the rosiglitazone arm before the drug was replaced with the galactose arm. This participant was not included in the analysis.|||participants|||Number
1455036|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1455037|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3|ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.|Week 2, Month 1, 2, 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1455038|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 4, 5, 6|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1455039|NCT00814307|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2|ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Week 2, Month 1, 2|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1455040|NCT00814307|Primary|Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3|DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission.|Month 3|FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1455041|NCT00814307|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.|Baseline, Month 3|FAS population. ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively.|||units on a scale||Standard Deviation|Mean
1455042|NCT00814307|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 3|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. ‘N’ (number of participants analyzed)=participants evaluable for this measure.|||percentage of participants|||Number
1455043|NCT00814255|Secondary|Percent Change in or Time to Doubling of Serum Creatinine||Baseline and 6 months|No data were collected.||||||
1455044|NCT00814255|Secondary|Percent Change in Proteinuria||Baseline and 6 months|No data were collected.||||||
1455045|NCT00814255|Secondary|Number of Participants With Adverse Events||Up to 7 months||||participants|||Number
1455046|NCT00814255|Secondary|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Patient Satisfaction Score Using the Treatment Satisfaction Questionnaire for Medication (TSQM Questionnaire)|Baseline and 6 months|No data were collected.||||||
1455048|NCT00814177|Primary|Number of Patients With Prothrombin Time Results Within the Therapeutic Range After 2 Weeks|"The number of patients with follow-up INRs within the therapeutic range was compared for patients with a single dose skipped/reduced/added versus patients with no change of dose."|2 weeks||||participants|||Number
1455056|NCT00814164|Primary|Complete Remission (CR)|Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).|2 years|All treated and eligible patients|||percentage of participant||95% Confidence Interval|Number
1455057|NCT00814138|Secondary|MG Composite Change Over 12 Months|This scale is composed of components of the QMG, MG-ADL and the MMT. These components have been shown to be the most responsive in previous clinical trials. Each item in the QMG, MG-ADL and the MMT was weighed (Rasch analysis performed) and then assigned a score. Score would range from 0 (no effects from the myasthenia gravis) to a score of 50. A participant with a score of 50 wwould be in the hospital on a ventilator.|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
1455058|NCT00814138|Secondary|MG-ADL 12 Month Change|The MG-ADL is an 8 item scale developed to assess myasthenia gravis symptoms. Score will range from 0 (normal - no MG symptoms) to 24 (severe MG symptoms)|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
1455059|NCT00814138|Secondary|MGQOL 12 Month Change|This test is a 15 item patient-reported scale indicating how myasthenia gravis affects the quality of life. Each item is graded as how true each statement has been over the past 7 days. The scale is 0=Not at all, 1= a little bit, 2= somewhat, 3= quite a bit and 4= very much. The numbers are then added to produce a total score. The MGQOL score would range from 0 (no MG symptoms that affected their quality of life) to a score of 60 (MG symptoms affected they quality of life very much).|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
1455060|NCT00814138|Secondary|Manual Muscle Testing 12 Month Change|This measurement was developed to measure the strength of muscle groups in the face, neck, arms and legs. Measurement is made by grading the amount of weakness. Participants are graded as having normal, mild (25%) weakness, moderate (50%) weakness or severe (75%) weakness and 4 = paralyzed/unable to do. Normal would receive a score of 0, mild would receive a score of 1, moderate would receive a score of 2, severe would receive a score of 3 and unable to perform would receive a score of 4. Range would be from 0 (no weakness) to 76 (complete paralysis).|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
1455061|NCT00814138|Secondary|Quantitative Myasthenia Gravis (QMG) Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The scale is from 0 - 3 for each item, with 0 meaning normal and 3 is severe. Total score can range from 0 to 39.|Change from Baseline to Month 12||||units on a scale||95% Confidence Interval|Mean
1455062|NCT00814138|Secondary|Average Prednisone Daily Dose (mg/Day)|Participants were asked to fill out the amount of prednisone they took every day on a paper diary.|Total length of time daily dose information was collected, i.e. 9 months.||||mg/day||95% Confidence Interval|Mean
1455063|NCT00814138|Primary|Total Prednisone Dose Area Under the Curve|The primary outcome measure was the nine-month prednisone area under the dose-time curve (AUDTC, months 4-12). The AUDTC was chosen because it accounted for changes in the prednisone dose that could occur frequently during a month.|9 months|Myasthenia Gravis patients aged 18 and older that were acetylcholine antibody positive with a myasthenia gravis foundation score of Grade II, III or IV.|||mg*Months||95% Confidence Interval|Number
1455064|NCT00813995|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1455065|NCT00813995|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1455066|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||Percent||95% Confidence Interval|Least Squares Mean
1455067|NCT00813995|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||Percent||95% Confidence Interval|Least Squares Mean
1455068|NCT00813995|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and Week 24|Full Analysis Set (defined as a subset of all randomized participants who received at least one dose of double-blind study medication, and had both a baseline [randomization] measurement and a post-randomization measurement) using last observation carried forward for missing data.|||Percent||95% Confidence Interval|Least Squares Mean
1455595|NCT00810901|Secondary|Talked to Parents About Choice to be Organ Donor on License at 12 Months|Number of teens who talk had not talked to parents at baseline but reported they had talked to their parents about the choice to become an organ donor on their driver's license at 12 months|12 months||||participants||95% Confidence Interval|Number
1455070|NCT00813943|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) and Lab Parameters||Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Any clinically significant abnormal ECG and lab finding was planned to be reported as AE only so they have been captured in the below mentioned adverse event section||||||
1455071|NCT00813943|Secondary|Number of Participants With AEs Belonging to Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) Thromboembolic Events and Hemorrhage With NCI−CTC Toxicity Grade 3 or 4|Thromboembolic events (standardized MedDRA query [SMQ]) Grade 3 or 4 AEs encompassed hemiparesis and cerebrovascular accident, pulmonary embolism, and deep vein thrombosis. Thromboembolic events (SMQ) of any grade and of Grade 3 or 4 were generally more frequent in the Cilengitide + Temozolomide/Radiotherapy group than in the Temozolomide/Radiotherapy group but were still in the expected range of this patient population The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
1455072|NCT00813943|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, Treatment-Related AEs, Treatment-Related Serious AEs, AEs Leading to Death, Treatment-Related AEs Leading to Death, AEs of Grade 3 or 4 and Treatment-Related AEs of Grade 3 or 4|An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Treatment-emergent AEs are the events between first dose of study drug and up to 28 days after last dose of study treatment. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-related AEs are the AEs which are suspected to be reasonably related to the study treatment (cilengitide, or radiotherapy, or temozolomide) as per investigator assessment. The severity of AEs was assessed according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE) (Version 3.0): Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling. Note: Death (Grade 5) was regarded as an outcome.|Time from first dose up to 28 days after last dose of study treatment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date (07 Feb 2013)|Safety population included all the participants who received any dose of study treatment that is Cilengitide, Temozolomide or Radiotherapy. According to trial design safety data in trial arms (Cilengitide vs Control) were collected based on different visit frequency and different safety surveillance period.|||Participants|||Number
1455073|NCT00813943|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz) and Apparent Volume of Distribution at Steady State (Vss)|The Vz (after single dose) and Vss (after repeated doses) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||liter||Standard Deviation|Mean
1455074|NCT00813943|Secondary|Plasma Clearance (CL)|The CL for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||milliliter per minute||Standard Deviation|Mean
1455075|NCT00813943|Secondary|Mean Residence Time From Time 0 to Infinity (MRT [0-infinity])|The MRT (0-infinity) for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hour||Standard Deviation|Mean
1455076|NCT00813943|Secondary|Apparent Terminal Rate Constant|The apparent terminal rate constant for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||per hour||Standard Deviation|Mean
1455077|NCT00813943|Secondary|Plasma Concentration at Pre-dose (Cpre) and Plasma Concentration at End of Infusion (CT)|The Cpre and CT for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. One participant had implausible pre-dose concentration."|||ng/mL||Standard Deviation|Mean
1455101|NCT00813761|Secondary|Intensity of Physiological Outcomes|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to Solution Induced Corneal Staining (SICS). These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.|||units on a scale||Standard Deviation|Least Squares Mean
1455078|NCT00813943|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) and Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24])|The AUC (0-infinity) and AUC (0-24) for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hour*ng/mL||Standard Deviation|Mean
1455079|NCT00813943|Secondary|Time to Maximum Plasma Concentration (Tmax) and Terminal Elimination Half-Life (t1/2)|The Tmax and t1/2 for cilengitide were calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||hours||Standard Deviation|Mean
1455080|NCT00813943|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Cmax for cilengitide was calculated by non-compartmental analysis using the computer program WinNonlin, Version 6.2. Cilengitide plasma concentrations were determined after dosing on Day 1 (single dose) and Day 5 (repeated doses) of Week 1.|Days 1 and 5 of Week 1|"Only Cilengitide (5-times) + Temozolomide + Radiotherapy group was analyzed for this outcome measure as per planned analysis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1455081|NCT00813943|Secondary|Progression Free Survival (PFS) Time - Investigator and Independent Read|The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
1455082|NCT00813943|Primary|Overall Survival (OS) Time|The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.|Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Jun 2009 until cut-off date, (07 Feb 2013)|ITT population included all the participants who were randomized to study treatment.|||Months||95% Confidence Interval|Median
1455083|NCT00813917|Primary|7-day Point Prevalence All Tobacco Abstinence|7-day point prevalence all tobacco abstinence at week 12 (end of treatment)confirmed by urine cotinine less than 50ng/ml|12 weeks - end of treatment||||participants|||Number
1455084|NCT00813904|Secondary|Number of Participants With AEs by Maximum Severity|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.|Baseline to Day 29, continuously|All participants who received treatment with rThrombin.|||Participants|||Number
1455085|NCT00813904|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation|An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline through Day 29, continuously|All participants who received treatment with rThrombin.|||Participants|||Number
1455086|NCT00813904|Primary|Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29|Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.|At baseline and Day 29|Participants who received treatment with rThrombin and had data available from both baseline and Day 29 antibody assessments.|||Participants|||Number
1455087|NCT00813865|Secondary|Change From Baseline To EOT In Volume Of Liver As Assessed By MRI|Standard MRI procedures were used to measure the volume of the liver. The baseline value was defined as the value recorded on Days 1 to 3 of the study (certain values could have been carried over from the last assessment in the lead-in study, GAU-CL-202). A negative change from Baseline indicates that liver volume decreased.|Baseline, Month 30|PD Population: all participants in the Safety Population who had a baseline and at least 1 post-baseline PD measurement. Seven of 8 participants did not complete the study and did not contribute data to this endpoint.|||cm^3|||Number
1455088|NCT00813865|Secondary|Change From Baseline To EOT In Volume Of Spleen As Assessed By Magnetic Resonance Imaging (MRI)|Standard MRI procedures were used to measure the volume of the spleen. The baseline value was defined as the value recorded on Days 1 to 3 of the study (certain values could have been carried over from the last assessment in the lead-in study, GAU-CL-202). A negative change from Baseline indicates that spleen volume decreased.|Baseline, Month 30|PD Population: all participants in the Safety Population who had a baseline and at least 1 post-baseline PD measurement. Seven of 8 participants did not complete the study and did not contribute data to this endpoint.|||cubic centimeters (cm^3)|||Number
1455121|NCT00813748|Primary|Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event – Case Participants|Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455089|NCT00813865|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as any adverse event (AE) with start date on or after administration of study drug or pre-existing conditions that worsened on or after the start of the first study drug administration (on Day 1). A severe AE defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through the end of follow-up is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Day 1 (after dosing) through end of follow-up (6 months after EOT)|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
1455090|NCT00813813|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population|||units on a scale||Standard Deviation|Mean
1455091|NCT00813813|Secondary|Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).|12 Months|FAS Population|||units on a scale||Standard Deviation|Mean
1455092|NCT00813813|Secondary|Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline|The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
1455093|NCT00813813|Primary|Treatment Emergent Adverse Events- Relationship to Study Drug|Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.|Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up|Safety Population|||participants|||Number
1455094|NCT00813813|Secondary|Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline|The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.|12 months|FAS Population|||units on a scale||Standard Deviation|Mean
1455095|NCT00813813|Primary|Neurological Assessment for Motor Function and Reflexes/Sensory|"Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.~For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.~For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs."|12 months|Safety Population|||participants|||Number
1455096|NCT00813800|Secondary|Young Mania Rating Scale (YMRS) at 12 Weeks|YMRS is an eleven-item, multiple choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes in patients already diagnosed with mania. Lowest score = 0, normal subject; Highest score = 60, highly manic subject. For this scale the following scores are associated with these grades of severity: mania (YMRS = 20), hypomania (YMRS = 12), under 5 is classified as non-manic. Young RC, Biggs JT, Ziegler Ve, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. BR J Psychiatry 1978; 133:429-435.|12 weeks|Intention to Treat (ITT)|||Units on a Scale||Standard Deviation|Mean
1455097|NCT00813800|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) at 12 Weeks|MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item on the MADRS is scaled 0 through 6. Lowest score = 0, would indicate no depressive symptoms. Highest score = 60, indicating extreme depression. MADRS score > 20 is syndromal depression. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382-389.|12 weeks|Intention to Treat (ITT)|||Units on a Scale||Standard Deviation|Mean
1455098|NCT00813800|Primary|Carbon Monoxide Breath Level at 12 Weeks|Measured by expired breath in parts per million (ppm)|12 weeks|Intention to Treat (ITT)|||ppm||Standard Deviation|Mean
1455099|NCT00813761|Secondary|Physiological Responses|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale)."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification.|||units on a scale||Standard Deviation|Least Squares Mean
1455100|NCT00813761|Secondary|Wearing Time and Comfortable Wearing Time|"Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for Solution Induced Corneal Staining (SICS). Average wearing time and average comfortable wearing time."|24 weeks|All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification.|||hours||Standard Deviation|Least Squares Mean
1455343|NCT00812461|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS|||percentage of participants|||Number
1455102|NCT00813761|Primary|Tarsal Roughness|The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency & superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
1455103|NCT00813761|Primary|Upper Tarsal Redness|Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
1455104|NCT00813761|Primary|Lower Tarsal Redness|Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
1455105|NCT00813761|Primary|Bulbar Redness|Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
1455106|NCT00813761|Primary|Limbal Redness|Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|eyes|Standard Error|Least Squares Mean
1455107|NCT00813761|Primary|Average Corneal Fluorescein Staining Area|corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|Eyes|Standard Error|Least Squares Mean
1455108|NCT00813761|Primary|Average Corneal Fluorescein Type Staining|staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale|Eyes|Standard Error|Least Squares Mean
1455109|NCT00813761|Primary|Frequency of Tearing|Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
1455110|NCT00813761|Primary|Frequency of Itching|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
1455111|NCT00813761|Primary|Frequency of Eye Burning/Stinging|Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
1455112|NCT00813761|Primary|Frequency of Daily Lens Dryness|Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
1455113|NCT00813761|Primary|Frequency of Eye Discomfort|Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
1455114|NCT00813761|Primary|Lens Comfort|Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||units on a scale||Standard Error|Least Squares Mean
1455115|NCT00813761|Primary|Average Daily Comfortable Wear Time|Average hours per day that contact lens were worn comfortably.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||Hours||Standard Error|Least Squares Mean
1455116|NCT00813761|Primary|Average Daily Wear Time|Average hours per day that contact lens were worn.|24 weeks|Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.|||Hours||Standard Error|Least Squares Mean
1455117|NCT00813748|Primary|Number of Participants With ATA – Skin Testing Substudy|Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.|Substudy Week 10|Skin test substudy: all enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
1455118|NCT00813748|Primary|Number of Participants With Positive Skin Reaction After Skin Prick Test – Skin Testing Substudy||Substudy Day 1|Skin test substudy: all enrolled participants. One participant discontinued prematurely from the skin test substudy before providing data and was excluded.|||participants|||Number
1455119|NCT00813748|Primary|Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study|Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
1455120|NCT00813748|Primary|Medications Within Two Weeks Prior to Blood Draw|Number of participants in each medication class is reported. Participants could have received more than 1 medication class.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455122|NCT00813748|Primary|Treatment Following Subsequent Unadjudicated Anaphylactic Events – Case Participants|Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
1455123|NCT00813748|Primary|Number of Participants With Subsequent Unadjudicated Anaphylactic Events – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455124|NCT00813748|Primary|Treatment Following Prior Unadjudicated Anaphylactic Events – Case Participants|Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||participants|||Number
1455125|NCT00813748|Primary|Number of Participants With Prior Unadjudicated Anaphylactic Events – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455126|NCT00813748|Primary|Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event – Case Participants||Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455127|NCT00813748|Primary|Outcome Attributed to Adjudicated Anaphylactic Event – Case Participants|Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455128|NCT00813748|Primary|Treatment Received Following Adjudicated Anaphylactic Event – Case Participants|Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455129|NCT00813748|Primary|Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred – Case Participants|Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455130|NCT00813748|Primary|Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms – Case Participants|Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455131|NCT00813748|Primary|Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms – Case Participants||Baseline (Enrollment Visit)|All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.|||minutes||Full Range|Median
1455132|NCT00813748|Primary|Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events – Case Participants|Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.|Baseline (Enrollment Visit)|All enrolled participants.|||participants|||Number
1455133|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 60|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1455134|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 60|BAbs are all antibodies which are capable of binding to the RNF irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA.|Month 60|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||participants|||Number
1455144|NCT00813709|Secondary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to Month 60|CDMS was defined by the occurrence of a second attack or relapse over 60 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||Cumulative % of participants with CDMS||95% Confidence Interval|Number
1455135|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 60|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Z-score||Standard Deviation|Mean
1455136|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 60|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 60 was calculated as EDSS score at Month 60 minus EDSS score at baseline.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1455137|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 60|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||percentage of participants|||Number
1455138|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 60|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from ‘0-60’. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1455139|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) at Month 60|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||percentage of participants|||Number
1455140|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 60|Percent Change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 60|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||percent change||Standard Deviation|Mean
1455141|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Volume, and Time Constant 2 (T2) Lesion Volume at Month 60|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions.|Baseline (Day 1 of Study 27025), Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||mm^3||Standard Deviation|Mean
1455142|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New T1 Lesions Per Participant Per Scan at Month 60|Number of CUA lesions, new T2 lesions, new Gd+ Lesions and new T1 lesions were measured by using MRI scans.|Month 60|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||lesions||Standard Deviation|Mean
1455143|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 60 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 60 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||% of participants with EDSS progression|||Number
1455154|NCT00813709|Secondary|Number of Combined Unique Active (CUA) Lesions, New Time Constant 2 (T2) Lesions, New Gadolinium Enhanced (Gd+) Lesions and New Time Constant 1 (T1) Lesions Per Participant Per Scan at Month 36|Number of CUA lesions, new T2 lesions, new Gd+ lesions and new T1 lesions were measured by using MRI scans.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||lesions||Standard Deviation|Mean
1455145|NCT00813709|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.|Month 24 up to Month 36 (DB treatment period for study 28981 (REFLEXION)|DB Safety Population 28981 (REFLEXION) included all the participants who discontinued DB treatment in REFLEX study 27025 (NCT00404352) and were enrolled in 28981 (REFLEXION) study and received at least one dose of DB treatment in this study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1455146|NCT00813709|Secondary|Numbers of Participants With Binding Antibodies (BAb) and Neutralizing Antibody (NAb) at Month 36|BAbs are all antibodies which are capable of binding to the investigational drug molecule (RNF) irrespective of their binding site. NAbs are defined as a subgroup of BAbs which bind to the active sites of the RNF and therefore neutralize its potency. NAbs were detected using a viral cytopathic assay. BAbs were measured by using an ELISA (Enzyme-linked immunosorbent assay).|Month 36|Data has been presented as per planned analysis for integrated DB population which included all participants who received at least one dose of DB treatment in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||participants|||Number
1455147|NCT00813709|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Month 36|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3).|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Z-score||Standard Deviation|Mean
1455148|NCT00813709|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 36|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. The change in EDSS score at Month 36 was calculated as EDSS score at Month 36 minus EDSS score at baseline.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1455149|NCT00813709|Secondary|Percentage of Relapse-Free Participants at Month 36|A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||Percentage of participants|||Number
1455150|NCT00813709|Secondary|Change From Baseline in Paced Auditory Serial Addition Test 3 (PASAT-3) Score at Month 36|The Paced Auditory Serial Addition Test (PASAT) is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Score ranges from ‘0-60’. Higher scores reflect better neurological function and a positive change from baseline indicates improvement.|Baseline (Day of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||units on a scale||Standard Deviation|Mean
1455151|NCT00813709|Secondary|Percentage of Participants With Conversion to McDonald Multiple Sclerosis (MS) up to 36 Months|The McDonald criteria use dissemination in time and space established by MRI findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new T2 or Gd+ lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions.|Baseline (Day 1 of Study 27025) up to CDMS conversion and/or up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||percentage of participants|||Number
1455152|NCT00813709|Secondary|Percent Change From Baseline in Brain Volume at Month 36|Percent change in brain volume was measured by using MRI scans.|Baseline (Day 1 of Study 27025), Month 36|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure at this time point.|||percent change||Standard Deviation|Mean
1455153|NCT00813709|Secondary|Change From Baseline in Time Constant 1 (T1) Hypointense Lesion Volume and Time Constant 2 (T2) Lesion Volume at Month 36|Change from baseline in lesion volume was measured by using MRI scans for T1 hypointense lesions and T2 lesions at Month 36|Baseline (Day 1 of Study 27025), Month 36|"Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352). n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||cubic millimeter (mm^3)||Standard Deviation|Mean
1455155|NCT00813709|Secondary|Time to Confirmed Expanded Disability Status Scale (EDSS) Progression up to 36 Months|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. Time to confirmed EDSS progression was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with confirmed EDSS progression.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||% of participants with EDSS progression|||Number
1455156|NCT00813709|Primary|Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Defined by Either a Second Attack or a Sustained Increase (Greater Than or Equal to 1.5 Points) in the Expanded Disability Status Scale (EDSS) Score up to 36 Months|CDMS was defined by the occurrence of a second attack or relapse over 36 months in participants who presented with clinically isolated syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI) scan. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]) was calculated. Time to conversion to CDMS was represented by Kaplan-Meier estimates of the cumulative percentage (%) of participants with CDMS.|Baseline (Day 1 of Study 27025) up to 36 Months|Data has been presented as per planned analysis for integrated ITT population which included all participants who were randomized in REFLEX study 27025 (NCT00404352).|||Cumulative % of participants with CDMS||95% Confidence Interval|Number
1455157|NCT00813592|Secondary|To Characterize the Safety and Tolerability of SOM230|Number of participants to experience adverse events|Monthly from study entry until subject taken off study, average 28 months||||participants|||Number
1455158|NCT00813592|Secondary|To Determine the Clinical Benefit Rate (CR + PR + Stable Disease) of SOM230||November 2011|||||||
1455159|NCT00813592|Secondary|To Establish the Median PFS and Overall Survival (OS)||November 2011|||||||
1455160|NCT00813592|Secondary|To Establish the 6-month Progression-free Survival Rate||November 2011|||||||
1455161|NCT00813592|Secondary|To Determine the Duration of Response to SOM230||November 2011|||||||
1455162|NCT00813592|Primary|Objective Response Rate (ORR) of SOM230 Monotherapy in Meningioma|Measured the percentage of participants achieving a complete response or partial response as opposed to those participants with progressive disease or stable disease.|November 2011|||||||
1455163|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC)Endpoint|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|End of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
1455164|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period."|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
1455165|NCT00813488|Secondary|Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.~The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)."|Two months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
1455166|NCT00813488|Secondary|Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment|"The CGIC is a standardized tool that measures the change in a patient’s overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=–3, much worse=–2, minimally worse=–1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period."|One month after start of open-label extension|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Unit on a scale||Standard Deviation|Mean
1455167|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) Endpoint|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period.|At conclusion of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on a scale||Standard Deviation|Mean
1455264|NCT00812968|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lenalidomide|Time to maximum observed plasma concentration of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population|||hours||Full Range|Median
1455168|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period.|3 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on scale||Standard Deviation|Mean
1455169|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period.|2 months after start of open-label extension period|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Units on scale||Standard Deviation|Mean
1455170|NCT00813488|Secondary|Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment|The PGIC is a standardized self-report tool that measures the change in a patient’s overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= –3, much worse= –2, minimally worse= –1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period.|One month after start of open-label treatment|Open-Label Efficacy Assessment Set includes all subjects who were randomly assigned to the open-label treatments in the extension period and had an efficacy assessment for at least one of the efficacy questionnaires.|||Unit on a scale||Standard Deviation|Mean
1455171|NCT00813488|Secondary|Breakthrough Pain Preference Questionnaire|The BTP preference questionnaire is a questionnaire used to measure patients’ preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient’s preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference.|At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.|Double-blind safety analysis set: 143 subjects who received both study drugs in this crossover study completed the Breakthrough Pain Preference Questionnaire after completing treatment|||Participants|||Number
1455172|NCT00813488|Secondary|Medication Performance Assessment 60 Minutes Post-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|60 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Episodes|Participants||Number
1455173|NCT00813488|Secondary|Medication Performance Assessment 30 Minutes Post-treatment|The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient’s paper diary. Patients were asked “How well did your study medication perform in controlling this breakthrough pain episode?” The number of episodes rated for each category were recorded.|30 minutes post-treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Episodes|Participants||Number
1455174|NCT00813488|Secondary|Use of Standard Rescue Medication|Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient’s diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded.|Throughout the double-blind treatment period|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Episodes|Participants||Number
1455175|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared.|Time of study drug administration until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455344|NCT00812461|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS|||g||Standard Error|Mean
1455176|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared.|From study drug administration until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455177|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared.|Time of study drug administration until 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455178|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared.|Time of study drug administration until 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455179|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes|Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared.|Time of study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455180|NCT00813488|Secondary|Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes|Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455181|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=60 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared.|Time of study drug treatment until 60 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455182|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=45 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared.|Time of study drug treatment until 45 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455596|NCT00810901|Primary|Designated Organ Donor Status on Driver's License|Number of students who reported not being donor at baseline but were donor at 12 months follow-up|12 months|t-test|||participants||95% Confidence Interval|Number
1455183|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=30 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared.|Time of study drug administration till 30 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455184|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=15 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared.|From study drug administration to 15 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455185|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment <=10 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared.|From study drug treatment until 10 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455186|NCT00813488|Secondary|Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes|Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared.|From time study drug was taken until 5 minutes after treatment|Full Analysis Set defined by at least one episode of breakthrough pain treated with FBT and at least one with oxycodone. No imputation was done if subject never answered APR/MPR question. If responded only as no, remaining missing imputed as no. If at least 1 yes, remaining missing imputed as yes.|||Episodes|Participants||Number
1455187|NCT00813488|Secondary|Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)|The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase.|From 5 minutes through 60 minutes after study drug treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Percentage change||Standard Deviation|Mean
1455188|NCT00813488|Secondary|Total Pain Relief at 60 Minutes (TOTPAR60)|"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes to 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||units on a scale|Participants|Standard Error|Least Squares Mean
1455189|NCT00813488|Secondary|Pain Relief Score at 60 Minutes Post-treatment|The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|60 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1455265|NCT00812968|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lenalidomide|Maximum observed plasma concentration of lenalidomide after a single dose on Day and after multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|Pharmacokinetic (PK) population: all patients who adhered to the study treatment during the course of PK assessment (Days 1 to 5 of Cycle 1) and from whom blood and urine samples were collected.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455190|NCT00813488|Secondary|Pain Relief Score at 45 Minutes Post-treatment|The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|45 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1455191|NCT00813488|Secondary|Pain Relief Score at 30 Minutes Post-treatment|The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|30 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1455192|NCT00813488|Secondary|Pain Relief Score at 15 Minutes Post-treatment|The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|15 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1455193|NCT00813488|Secondary|Pain Relief Score at 10 Minutes Post-treatment|The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|10 minutes after treatment with study drug|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1455194|NCT00813488|Secondary|Pain Relief (PR) Score at 5 Minutes Post-treatment|The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient’s diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete).|5 minutes after treatment|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PR scores.|||Units on a scale||Standard Deviation|Mean
1455195|NCT00813488|Secondary|Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)|"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry."|From 5 minutes after dosing through 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1455196|NCT00813488|Secondary|Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)|PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|From 5 minutes after dosing through 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1455197|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
1455335|NCT00812487|Secondary|Brain Natriuretic Peptide (BNP)|Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits|72 hours||||pg/ml||Inter-Quartile Range|Median
1455336|NCT00812487|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).|72 hours||||mg/dl||Inter-Quartile Range|Median
1455198|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
1455199|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
1455200|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment|Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Baseline (immediately pre-dose) and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
1455201|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period.|Immediately before treatment and 10 minutes after treatment.|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
1455202|NCT00813488|Secondary|Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Percentage change||Standard Deviation|Mean
1455203|NCT00813488|Secondary|Pain Intensity Difference (PID) at 60 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 60 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1455204|NCT00813488|Secondary|Pain Intensity Difference (PID) at 45 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 45 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1455205|NCT00813488|Secondary|Pain Intensity Difference (PID) at 30 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 30 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1455206|NCT00813488|Secondary|Pain Intensity Difference (PID) at 10 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 10 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1455207|NCT00813488|Secondary|Pain Intensity Difference (PID) at 5 Minutes Post-treatment|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 5 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on a scale|Participants|Standard Error|Least Squares Mean
1455208|NCT00813488|Primary|Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)|Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.|Immediately pre-dose and 15 minutes after dosing|Full Analysis Set defined as having at least one evaluable episode of breakthrough pain treated with FBT and at least one with oxycodone. An episode was evaluable if it had a valid pain intensity measurement immediately prior to drug administration. No imputation for missing breakthrough pain episodes, but LOCF was applied for missing PI scores.|||Units on scale|Participants|Standard Error|Least Squares Mean
1455209|NCT00813319|Primary|Total Doses Received of HPV Vaccine|As an additional primary outcome, we assessed the total number of vaccine doses received|measured at 7-months post randomization||||Doses|||Number
1455210|NCT00813319|Secondary|STD Incidence|Number of participants who tested positive for any STD 7 months post randomization, information was gathered via medical chart abstraction|7 months post randomization||||participants|||Number
1455211|NCT00813319|Primary|GARDASIL Vaccination Uptake and Compliance With Second and Third Doses|Number of participants who received at least 1 dose, 2 doses, 3 doses|measured at 7 months post-randomization||||participants|||Number
1455212|NCT00813176|Secondary|Mean Intraoperative Oxygenation During One-lung Ventilation|For each group, the mean intraoperative oxygenation (arterial partial pressure of oxygen measured by arterial blood gases) were taken during two-lung ventilation (baseline) and after 30 min of one-lung ventilation.|This measure occured during surgery.||||kPa||Standard Deviation|Mean
1455213|NCT00813176|Secondary|Number of Participants With Successful Reinflation|In each group, the number of Participants in which successful lung reinflation occurred.|This occurred during surgery.||||Participants|||Count of Participants
1455214|NCT00813176|Secondary|Time Required to Collapse the Lung|For each group, the mean time for lung isolation/collapse was measured from the institution of one-lung ventilation to the time of total lung collapse.|This measurement occurred during surgery.||||Minutes||Standard Deviation|Mean
1455215|NCT00813176|Secondary|Effectiveness of Lung Collapse|For each group, the number of participants in which lung collapse was evaluated as: (i) good—complete collapse without surgical interference, (ii) fair—total collapse, but with residual air, and (iii) poor—no or partial collapse, lung inflated and interfering with the surgical exposure.|This measure occured during surgery just after intubation.||||Participants|||Count of Participants
1455216|NCT00813176|Primary|Number of Participants in Which the Tube Was Successfully Positioned at First Attempt|Number of participants in each group in which the tube was successfully positioned at first attempt|This data measure was occurred during surgery.||||Participants|||Count of Participants
1455217|NCT00813176|Primary|Time Taken for Endotracheal Tube Placement Procedure.|"For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube.~Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope."|This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.||||minutes||Standard Deviation|Mean
1455218|NCT00813150|Secondary|Overall Response Rate (ORR) - International Myeloma Working Group (IMWG) Response Criteria|Percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) is reported in the below table. IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescencec; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.|Up to 46 days after last bortezomib dose, or as soon as possible after early discontinuation of study treatment or before start of alternative anti-myeloma therapy|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.|||Percentage of participants|||Number
1455219|NCT00813150|Secondary|Overall Survival (OS)|Time interval in months time from randomisation to death from any cause.|From the date of randomization until Month 49|Intent-to-treat (ITT): Participants received at least 1 dose of study medication were included in the ITT analysis set. Participants still alive at the end of the study or dropped out will be censored with the last available date.|||Months||95% Confidence Interval|Median
1455220|NCT00813150|Secondary|Progression-Free Survival (PFS)|PFS is defined as time from randomization to myeloma progression according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of ≥25 percent from lowest response level in Serum M-component and/or (the absolute increase must be ≥0.5 g/dL) Urine M-component and/or (the absolute increase must be ≥200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be ≥10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65mmol/L) that can be attributed solely to the plasma cell proliferative disorder. PFS included disease progression as well as death.|From the date of randomization until the disease progression or participant's death from any cause whichever occured first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): all participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication. Participants without progression and who are still alive at the end of the study or dropped out will be censored with the last available date.|||Months||95% Confidence Interval|Median
1455221|NCT00813150|Primary|Time to Progression of Disease|’Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|From the date of randomization until the disease progression or participant's death from any cause whichever occurred first, as assessed up to 72 weeks after end of treatment visit (ie, 46 days after last dose of study medication)|Intent-to-treat (ITT): Participants who received at least one dose of study medication and in whom the primary efficacy parameter could be assessed at least once under study medication.|||Months||95% Confidence Interval|Median
1455222|NCT00813111|Secondary|Number of Participants With Adverse Events||30 days|||||||
1455223|NCT00813111|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|"Assessments of postoperative pain included pain intensity at rest (using the NRS at rest [NRS-R] and with activity [using the NRS-A]) where the prescribed activity was raising both arms.~Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain."|through 72 hours|Note: 136 subjects were randomized and received study drug and were included in the analyses. 10 subjects were randomized but not dosed and 4 additional subjects failed screening, resulting in 122 subjects.|||Units on a scale*hours||Standard Deviation|Mean
1455224|NCT00813098|Secondary|Change From Baseline at Week 4 on the Global Improvement Score.|"The IBS Global Improvement Scale (IBS-GAI) asks Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been: 1-substantially worse, 2-moderately worse, 3-slightly worse, 4-no change, 5-slightly improved, 6-moderately improved, 7-substantially improved? The mean score for Week 4 was subtracted from the mean baseline score to obtain the mean change from baseline on the Global Improvement Score."|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1455225|NCT00813098|Secondary|Change From Baseline at Week 4 on the Severity of Bloating|"Subjects recorded in the daily diary the level of bloating they felt on a daily basis using a 100 mm visual analog scale (with 0 being not at all and 100 mm being worst possible). The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline in severity of bloating."|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1455226|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Frequency|Subjects recorded the number of times they passed stool on a daily basis in the daily diary. The mean for Week 4 was subtracted from the baseline mean to obtain the mean change from baseline in stool frequency.|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Number of daily stools||Standard Deviation|Mean
1455337|NCT00812487|Secondary|Pre-ejection Period (PEP)|Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.|24 hours||||ms||Standard Deviation|Mean
1455227|NCT00813098|Secondary|Change From Baseline at Week 4 in Stool Consistency Scores|Stool consistency was evaluated using the 7-point Bristol Stool Scale in which a score of 1 indicates separate hard lumps, 2 indicates sausage shaped but lumpy, 3 indicates sausage-like with cracks on the surface, 4 indicates sausage-like but smooth and soft, 5 indicates soft blobs with clear cut edges, 6 indicates fluffy pieces with ragged edges, and 7 indicates watery with no solid pieces. The mean score for Week 4 was subtracted from the baseline mean score to obtain the mean change from baseline.|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1455228|NCT00813098|Secondary|Change From Baseline at Week 4 in Proportion of Days Per Week When Experiencing Urgency to Defecate|"To assess sensation of urgency to defecate on a daily basis, subjects recorded in their daily diary a response to the following question,Have you felt or experienced a sense of urgency to pass stool today? The mean score (proportion of days per week when the subject experienced an urge to defecate) for Week 4 was subtracted from the baseline mean score to determine the mean change from baseline."|Baseline to Week 4|Per protocol population; Last observation carried forward.|||Score on a scale||Standard Deviation|Mean
1455229|NCT00813098|Primary|Subjects Who Experienced Relief of IBS Pain and Discomfort at Week 4|"The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"|Week 4|Per protocol population; Last observation carried forward.|||Participants|||Number
1455230|NCT00812981|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1455231|NCT00812981|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 51|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1455232|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1455233|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1455234|NCT00812981|Secondary|Number of Subjects With Any AESIs|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|During the entire study period (from Day 0 up to Day 180)|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1455235|NCT00812981|Secondary|Number of Subjects With Any Adverse Events of Specific Interest (AESIs)|An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to 51 days after the first vaccination|The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
1455236|NCT00812981|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.|||Participants|||Count of Participants
1455237|NCT00812981|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.|||Participants|||Count of Participants
1455508|NCT00811317|Secondary|Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard|Measuring the mean absolute relative difference (MARD) between the blood glucose measurement and CGM glucose readings, on three different CGM devices: Dexcom, Guardian and Navigator|24 hours||||percent absolute difference||Standard Deviation|Mean
1455238|NCT00812981|Secondary|Number of Seroconverted Subjects for Neutralizing Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
1455239|NCT00812981|Secondary|Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value|Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
1455240|NCT00812981|Secondary|Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Titers||95% Confidence Interval|Geometric Mean
1455241|NCT00812981|Secondary|Number of Seroprotected Subjects for H5N1 HI Antibodies|A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
1455242|NCT00812981|Secondary|Seroconversion Factor (SCF) for H5N1 HI Antibodies|The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Fold change||95% Confidence Interval|Geometric Mean
1455243|NCT00812981|Secondary|Number of Seroconverted Subjects Against Two Strains of Influenza Disease|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 42 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
1455244|NCT00812981|Secondary|Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value|The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Days 0, 42 and 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
1455245|NCT00812981|Secondary|Titers for Serum H5N1 HI Antibodies|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.|At Day 0 and Day 180|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Titers||95% Confidence Interval|Geometric Mean
1455246|NCT00812981|Primary|Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Titers||95% Confidence Interval|Geometric Mean
1455247|NCT00812968|Secondary|Percentage of Bone Marrow Promyelocytes|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."|||Percentage of promyelocytes||Full Range|Median
1455248|NCT00812968|Secondary|Percentage of Bone Marrow Myeloblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|"Efficacy population with available bone marrow specimens at each time point (indicated by N)."|||Percentage of myeloblasts||Full Range|Median
1455249|NCT00812968|Secondary|Change From Baseline in Percentage of Bone Marrow Erythroblasts|Bone marrow morphology was assessed by the central hematologic reviewers based on the locally-prepared bone marrow smear slide and clot section.|Baseline, at the end of Cycle 3 (Day 85) and Cycle 6 (Day 169).|Efficacy population with available bone marrow specimens.|||Percentage of Bone Marrow Erythroblasts||Full Range|Median
1455250|NCT00812968|Secondary|Number of Participants With a Cytogenetic Response|"Cytogenetic (chromosome structure) abnormalities were assessed by a central cytogenetic reviewer based on prints and cytogenetic reports of the bone marrow sample from the central laboratory. Cytogenetic response was determined using the IWG (2000) criteria and categorized as either a major response or minor response. Twenty metaphases were analyzed for the determination of cytogenetic response.~A major response was defined as no detectable cytogenetic abnormality, if an abnormality was present at Baseline, sustained for consecutive 56 days during the treatment period. A minor response was defined as ≥ 50% reduction from Baseline in abnormal metaphases sustained for consecutive 56 days during the treatment period."|Response was assessed every 12 weeks through Week 156|Efficacy population|||participants|||Number
1455509|NCT00811317|Secondary|Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals||24 hours||||participants|||Number
1455510|NCT00811317|Secondary|Number of Participants Achieving a Stable Glucose Response to Insulin Dosing||24 hours||||participants|||Number
1455251|NCT00812968|Secondary|Number of Participants With a Platelet Response|"Platelet response was determined using the IWG (2000) criteria. Major response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 30,000/mm^3 increase sustained for consecutive 56 days during the treatment period. In platelet-transfusion-dependent patients at Baseline a major response is defined as stabilization of platelet counts and platelet transfusion independence sustained for consecutive 56 days during the treatment period.~Minor response in patients with Baseline platelet count < 100,000/mm^3 is defined as a ≥ 50% increase in platelet count with an absolute increase > 10,000/mm^3 and < 30,000/mm^3 sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with a Baseline platelet count of < 100,000/mm^3 or who were platelet-transfusion dependent at Baseline. There were no patients with platelet count of < 100,000/mm3 or who were platelet-transfusion dependent at Baseline, and thus platelet response was not evaluated.||||||
1455252|NCT00812968|Secondary|Number of Participants With a Neutrophil Response|"Neutrophil response was determined using the IWG (2000) criteria. A major response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase or a ≥ 500/mm^3 increase, whichever is greater, sustained for consecutive 56 days during the treatment period.~A minor response for participants with a Baseline neutrophil count < 1,500/mm^3 is defined as a ≥ 100% increase, but an absolute increase < 500/mm^3, sustained for consecutive 56 days during the treatment period."|Response was assessed every 28 days through Week 156|Efficacy population with Baseline neutrophil count < 1,500/mm^3.|||participants|||Number
1455253|NCT00812968|Secondary|Change From Baseline in Hemoglobin Concentration|Change in hemoglobin concentration from Baseline to the maximum observed value during the major erythroid response period for major erythroid responders.|Baseline and from Day1 until the maximum observed value (up to 155 weeks)|Efficacy population with a erythroid response|||g/dL||Full Range|Median
1455254|NCT00812968|Secondary|Duration of Erythroid Response|Duration of erythroid response was calculated as the time from the start of the first major or minor erythroid response to the end of the response. Similarly, duration of major erythroid response was calculated as the time from the start of the first major erythroid response to the end of the response. Response duration was censored at the last adequate assessment for patients who maintained response.|From the first dose of study drug through Week 156|Efficacy population with a erythroid response|||weeks||95% Confidence Interval|Median
1455255|NCT00812968|Secondary|Time to Erythroid Response|Time to erythroid response was calculated as the time from the first dose of study drug to the start of the first major or minor erythroid response. Similarly, time to major erythroid response was calculated as the time from the first dose of study drug to the start of the first major erythroid response.|From the first dose of study drug through Week 156|Efficacy population|||weeks||Full Range|Median
1455256|NCT00812968|Secondary|Number of Participants With a Erythroid Response|"Erythroid response was determined using the International Working Group (IWG) 2000 criteria, categorized as a major response or minor response.~A major response in patients with transfusion-dependent anemia (receiving ≥ 4.5 units of red blood cell (RBC) transfusion during 56 consecutive days at Baseline) is defined as RBC transfusion independence accompanied by a ≥1.0 g/dL increase from Baseline in hemoglobin sustained for 56 days consecutively during the treatment period. In patients with transfusion-independent anemia with hemoglobin < 10 g/dL at Baseline a major response is defined as a > 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days.~Minor response in patients with transfusion-dependent anemia defined as ≥ 50% decrease from Baseline in transfusion requirements sustained for consecutive 56 days, and in transfusion-independent patients as 1.0 to 2.0 g/dL increase from Baseline in hemoglobin sustained for consecutive 56 days."|Response was assessed every 28 days through Week 156.|Efficacy population: all patients who had a diagnosis of low- or intermediate-1-risk MDS associated with anemia based on confirmation by the central reviewers and received at least 1 dose of study drug.|||participants|||Number
1455257|NCT00812968|Secondary|Apparent Terminal Elimination Rate Constant of Lenalidomide|Apparent terminal elimination rate constant of lenalidomide determined after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||1/h||Geometric Coefficient of Variation|Geometric Mean
1455258|NCT00812968|Secondary|Apparent Total Plasma Clearance (CL/F) of Lenalidomide|Apparent total plasma clearance (CL/F) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||mL/minute||Geometric Coefficient of Variation|Geometric Mean
1455259|NCT00812968|Secondary|Apparent Volume of Distribution (VzF) of Lenalidomide|Apparent volume of distribution of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||liters||Geometric Coefficient of Variation|Geometric Mean
1455260|NCT00812968|Secondary|Terminal Half-life (T1/2) of Lenalidomide|The apparent terminal half-life is the time required for plasma concentration to decrease by 50% after pseudo-equilibrium of distribution has been reached, and calculated as the natural logarithm of 2 (0.693) / Apparent terminal rate constant (λz).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population with available data|||hours||Geometric Coefficient of Variation|Geometric Mean
1455261|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Lenalidomide|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) of lenalidomide after a single dose on Day 1.|Day 1 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455262|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Lenalidomide|Area under the plasma concentration-time curve over the dosing interval (AUCτ) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.|PK population with available data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455263|NCT00812968|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Lenalidomide|Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt) of lenalidomide after a single dose on Day 1 and multiple doses (Day 4).|Days 1 and 4 at predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours post-dose.|PK population|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455266|NCT00812968|Primary|Number of Participants With Adverse Events (AE)|"An AE that resulted in any of the following outcomes was defined as a serious adverse event (SAE):~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event.~The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event.~The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|After the first study dose until 28 days after completion of/discontinuation from the study (maximum time on study was 155 weeks).|Safety population: all patients who received at least 1 dose of study drug.|||participants|||Number
1455267|NCT00812955|Other Pre-specified|Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1455268|NCT00812955|Other Pre-specified|Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)|The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Inter-Quartile Range|Median
1455269|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1455270|NCT00812955|Secondary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set)|The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1455271|NCT00812955|Primary|Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)|"The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups:~ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set."|Baseline to 8 weeks|Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward.|||percent change||Standard Error|Mean
1455272|NCT00812929|Secondary|Derived Pharmacokinetic (PK) Parameters for GSK2190915|PK samples were supposed to be collected at 10 minutes prior to the exercise challenge at 2 hours, 9.5 hours and 24 hours.|Pre dose, 2 hours, 3.5 hours, 9.5 hours, 11 hours and 24 hours following exercise challenge of each treatment period|PK Population was defined as participants in the ‘All Subjects’ Population for whom a PK sample was obtained and analyzed. Data was not collected for this outcome measure.||||||
1455273|NCT00812929|Secondary|Percentage Change From Baseline in Urine Leukotriene E4 (LTE4)|Analysis of LTE4 levels in the urine samples indicated the extent of LTE4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (pre dose) up to 24 Hours post dose of each treatment period|PD Population. Only those participants available at the indicated time points were analyzed.|||Percent change||Full Range|Median
1455274|NCT00812929|Secondary|Percentage Change From Baseline in Blood Leukotriene B4 (LTB4)|Analysis LTB4 levels in the blood samples indicated the extent of LTB4 inhibition following administration of GSK2190915 compared to Baseline. Baseline was the pre dose value. Change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline (pre dose) up to 24 Hours post dose of each treatment period|Pharmacodynamics (PD) Population was defined as participants in the ‘All Subjects’ Population for whom a PD sample (blood or urine) was obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||Percent change||Full Range|Median
1455338|NCT00812487|Secondary|High Frequency Heart Rate Variability|High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.|24 hours||||ms^2||Inter-Quartile Range|Median
1455275|NCT00812929|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and medically significant.|Up to follow up (7 to 21 days) following last dose|All Subjects Population.|||Participants|||Count of Participants
1455276|NCT00812929|Secondary|Assessment of Hematology Parameters: Red Blood Cell Count (RBC)|Blood samples were collected for the assessment of hematology parameter for RBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Cells x 10^12 per liter||Standard Deviation|Mean
1455277|NCT00812929|Secondary|Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV)|Blood samples were collected for the assessment of hematology parameter for MCV at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Femtoliter||Standard Deviation|Mean
1455278|NCT00812929|Secondary|Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH)|Blood samples were collected for the assessment of hematology parameter for MCH at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed|||Picograms||Standard Deviation|Mean
1455279|NCT00812929|Secondary|Assessment of Hematology Parameters: Hematocrit|Blood samples were collected for the assessment of hematology parameters for hematocrit at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Deviation|Mean
1455280|NCT00812929|Secondary|Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples were collected for the assessment of hematology parameters for hemoglobin and MCHC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||G/L||Standard Deviation|Mean
1455281|NCT00812929|Secondary|Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC)|Blood samples were collected for the assessment of hematology parameters for basophils, eosinophils, lymphocytes, monocytes, TN, platelet count, WBC at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Cells x 10^9 per liter||Standard Deviation|Mean
1455282|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN)|Blood samples were collected for the assessment of clinical chemistry parameters for calcium, chloride, glucose, potassium, sodium and urea/BUN at pre dose and 25 hours and 30 minutes post dose. Participants had to fast for at least 8 hours prior to visit. Participants fasted for glucose blood sample. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Millimole per liter (mmol/L)||Standard Deviation|Mean
1455283|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine|Blood samples were collected for the assessment of clinical chemistry parameters for direct bilirubin, total bilirubin and creatinine at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants available at the indicated time points were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1455284|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT)|Blood samples were collected for the assessment of clinical chemistry parameters for ALP, ALT, AST and GGT at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants available at the indicated time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
1455285|NCT00812929|Secondary|Assessment of Clinical Chemistry Parameters: Albumin, Total Protein|Blood samples were collected for the assessment of clinical chemistry parameters for albumin and total protein at pre dose and 25 hours and 30 minutes. Participants had to fast for at least 8 hours prior to visit. During treatment periods, fasting continued until a light meal was allowed 1 hour post dose.|Pre dose and 25 hours and 30 minutes post dose of each treatment period|All Subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Gram/liter (G/L)||Standard Deviation|Mean
1455339|NCT00812461|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455286|NCT00812929|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|All participants rested for at least 10 minutes in the supine position prior to ECG recordings. ECG Baseline values for each treatment period was calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours, 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours. Participants with not clinically significant (NCS) abnormal values were reported. Potential clinical importance range for the ECG parameters are as follows: absolute QTc interval >450 millisecond (msec), increase from Baseline QTc >60 msec, PR interval <110 and >220 msec and QRS interval <75 and >110 msec. No participants reported clinically significant abnormal values.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period|All Subjects Population.|||Participants|||Count of Participants
1455287|NCT00812929|Secondary|Assessment of Vital Signs: Heart Rate (HR)|All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for HR for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period|All Subjects Population.|||Beats per minute||Standard Deviation|Mean
1455288|NCT00812929|Secondary|Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|All participants rested for at least 10 minutes in the supine position prior to vital signs recordings. Vital signs Baseline values for SBP and DBP for each treatment period were calculated using the mean value of triplicate pre dose readings. Triplicate readings were taken at least five minutes apart. Assessment was performed at pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge.|Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period|All Subjects Population was defined as all participants who received at least one dose of study medication.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1455289|NCT00812929|Secondary|Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge|Rescue medication was provided to participants at any time and it was strongly recommended for participants with a FEV1 decrease of at least 40% following exercise challenge compared to Baseline. Rescue medication was administered 0 to 90 minutes post exercise challenge. Statistical analysis was supposed to be performed using logistic regression, however, the data was too sparse to permit any formal statistical analysis.|0 to 90 minutes following exercise challenge of each treatment period|Efficacy Population.|||Participants|||Count of Participants
1455290|NCT00812929|Secondary|Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge|"The time from maximal percentage change in FEV1 to recovery to within 5% of pre challenge Baseline (in minutes) was derived using actual sampling times. Time to FEV1 recovery= [SAS date/time of recovery(a) FEV1 – SAS date/time of FEV1 Maximum % Change0-60] / 60, where a is earliest recorded FEV1 either above pre-challenge Baseline or within 5% below pre challenge Baseline. Any unscheduled FEV1 measurements taken after last scheduled post challenge measurement was considered when deriving this endpoint. A corresponding censoring variable was derived for analysis to indicate whether recovery to within 5% of pre-challenge Baseline was achieved. The censoring variable was set to 1 if recovery to within 5% of Baseline was achieved. If recovery was not evident from data collected, time to recovery was calculated using the date/time of the last available post challenge FEV1 assessment and censoring variable was set to zero. Analysis was performed using a Cox proportional hazards model."|0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period|Efficacy Population.|||Minutes||95% Confidence Interval|Median
1455291|NCT00812929|Secondary|Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60)|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge.Weighted mean FEV1 percentage change recorded during 0-60 minutes post challenge was determined for each challenge, by dividing area under curve (AUC) for percent change from Baseline FEV1 measurements at 5, 10, 15, 30, 45 and 60 minutes post challenge by time interval. Actual times were used to determine time interval where available; otherwise planned relative time was used. If one or more FEV1 values were missing, AUC was calculated over time interval of available values. If intermittent values were missing over a participant’s profile,it was assumed to be linear between 2 available values for calculation of AUC. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1.|Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period.|Efficacy Population.|||Percent change||Standard Error|Least Squares Mean
1455292|NCT00812929|Secondary|Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100*(FEV1 – Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at >=80% of the predicted value for 6 minutes), the FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period.|Efficacy Population.|||Percent change||Standard Error|Least Squares Mean
1455340|NCT00812461|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455511|NCT00811317|Secondary|Number of Carbohydrate Interventions||24 hours||||number of interventions|||Number
1455293|NCT00812929|Primary|Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose|FEV1 was recorded in triplicate, with participant encouraged to inhale fully despite any presence of chest tightness. For FEV1, a pre-challenge Baseline was defined for each challenge time point as maximum of triplicate measurements performed prior to challenge. The maximal percentage change within 60 minutes following exercise challenge was derived by taking minimum (i.e., most negative) percentage change in FEV1 over 5, 10, 15, 30, 45 and 60 minutes post challenge. Percent change FEV1 = 100*(FEV1 – Pre-challenge FEV1)/ Pre-challenge FEV1. If the exercise challenge was not completed successfully (i.e. heart rate maintained at >=80% of the predicted value for 6 minutes), FEV1 maximal percent change (0-60)was set to be missing. Analysis was performed using a mixed effects model, including period, treatment and covariates for predose FEV1. Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period.|The ‘Efficacy Population’ was defined as all participants who received at least one dose of study medication and are not major protocol violators.|||Percent change||Standard Error|Least Squares Mean
1455294|NCT00812916|Secondary|Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points|Does not include 2 outliers with >300 CFAE discrete points. Based on the user-defined definition of a CFAE complex, the system identifies the number of intervals between adjacent CFAE complexes and the cycle length of these intervals. This makes it possible to estimate the number of CFAE complexes within certain amplitude and duration values. A CFAE complex is defined by the system based on the intervals between the peaks. Therefore, clinically, the CFAE software includes an algorithm that enables detection of CFAE complexes. The automatic detection and distribution of CFAE signals is taking place during a 2.5 second intra-cardiac ECG recording. When the CFAE areas are completely eliminated, but the arrhythmia continues as organized atrial flutter or atrial tachycardia, the atrial tachy-arrhythmias may be mapped and ablated upon discretion of the investigator. Analyses occur post-procedure.|Procedural|Safety population with non-outlier endpoint reported|||points||Standard Deviation|Mean
1455295|NCT00812916|Secondary|Total Fluoroscopy Time|Mean total fluoroscopy time|Procedural|Safety population with fluoroscopy time reported|||minutes||Standard Deviation|Mean
1455296|NCT00812916|Secondary|Total Radiofrequency (RF) Duration|Total duration of all radiofrequency applications with exception of 12 outliers recording >150 minutes.|Procedural|Safety population with RF data reported|||minutes||Standard Deviation|Mean
1455297|NCT00812916|Secondary|Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time|Total of left and right atrium CFAE mapping times with exception of 9 outliers reporting total CFAE mapping time of >120 minutes|Procedural|Safety population with mapping time reported|||minutes||Standard Deviation|Mean
1455298|NCT00812916|Secondary|Total Ablation Time|Total time of ablation with exception of 10 outliers with >180 minutes of total ablation time reported|Procedural|Safety population with ablation time reported|||minutes||Standard Deviation|Mean
1455299|NCT00812916|Primary|Acute Success|Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion|End of procedure|Patients with CFAE-guided RF catheter ablation|||percentage achieving success||95% Confidence Interval|Number
1455300|NCT00812877|Secondary|Pulp Vitality|No evidence of pulpal resorption or calcification or periradicular radiolucency|Up to two years||||participants|||Number
1455301|NCT00812877|Primary|Tooth Survival|No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.|Up to two years|12 subjects were excluded in the Mineral Trioxide Aggregate group due to lack of follow-up (4 subjects were non-responsive; unable to contact 6 subjects; 2 subjects changed dentists) and 6 subjects were in the Calcium Hydroxide group (2 subjects were non-responsive; unable to contact 3 subjects; 1 subject was incarcerated).|||participants|||Number
1455302|NCT00812812|Secondary|Plasma Paroxetine Concentrations at 12 Hours and 24 Hours After Administration of Study Drug at Week 8 or Withdrawal|Summary statistics for the plasma paroxetine concentrations at each time point were calculated by the dosage just before blood sampling using data from participants in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).|Week 8 or Withdrawal (up to Week 8)|All participants who received paroxetine and in whom plasma samples were collected at either 12 hours (plus or minus 2 hours) or 24 hours (plus or minus 2 hours) after the last administration of the study drug at Week 8 or Withdrawal (up to Week 8).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1455303|NCT00812812|Secondary|Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-SI) Score at Weeks 1, 2, 3, 4, 6, and 8|CGI-SI is assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; and 7, among the most extremely ill. CGI-SI was assessed by the investigator. The change from Baseline in CGI-SI score was calculated as the score at Weeks 1, 2, 3, 4, 6, and 8 minus the score at Baseline.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.|||scores on a scale||Standard Deviation|Mean
1455304|NCT00812812|Secondary|Number of Clinical Global Impression - Global Improvement (CGI-GI) Responders at Weeks 1, 2, 3, 4, 6, and 8|CGI-GI is assessed on an 8-grade scale: 0, not assessed; 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. CGI-GI was assessed by the investigator. Participants who were rated as 1 (very much improved) or 2 (much improved) were categorized as CGI-GI responders.|Weeks 1, 2, 3, 4, 6, and 8|FAS. The analysis was performed on the OC dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week. The analysis of data at Week 8 was also performed on the LOCF dataset.|||participants|||Number
1455341|NCT00812461|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS|||units on a scale||Standard Error|Mean
1455305|NCT00812812|Secondary|Change From Baseline in the CDRS-R Total Score at Weeks 1, 2, 3, 4, and 6|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Weeks 1, 2, 3, 4, and 6|FAS. The analysis was performed on the observed case (OC) dataset. Participants whose observation was missing at a particular visit were not included in the analysis for that week.|||scores on a scale||Standard Error|Least Squares Mean
1455306|NCT00812812|Primary|Change From Baseline in the Children's Depression Rating Scale -Revised (CDRS-R) Total Score at Week 8|The CDRS-R has been widely used for the evaluation of children and adolescents with major depressive disorder (MDD). The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. The highest possible score is 113 (the most severe measure of depression), and the lowest is 17 (not suffering from depression). CDRS-R scores were assessed by the investigator. The change from Baseline in the CDRS-R total score was calculated as the total score at Week 8 minus the total score at Baseline. The data were adjusted with the total score at Baseline.|Baseline and Week 8|Full Analysis Set (FAS): all participants who entered the treatment phase, but excluding participants without the target indication, participants who received no tablet of the treatment phase medication, or participants who had no post-baseline CDRS-R data. The analysis was performed on the last observation carried forward (LOCF) dataset.|||scores on a scale||Standard Error|Least Squares Mean
1455307|NCT00812708|Secondary|Need to Explant or Exchange a Morcher Iris Diaphragm (Secondary Safety Measure)|Another secondary safety measure of the study was the need to explant or exchange a Morcher iris diaphragm within 1 year of implantation. Explantation in < 25% of patients was considered to be clinically acceptable.|Preoperatively and 1 year postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
1455308|NCT00812708|Secondary|Change in Endothelial Cell Count (Secondary Safety Measure)|A secondary safety measure of the study was the change in endothelial cell count. A loss of >10% of central corneal endothelial cells was considered clinically significant at the onset of the study. (Note, the 10% loss criterion was established before the 67B implant was added to the list of study devices. The 67B implant has an expected greater cell loss than that associated with the 96F, 96S, 50D, and 50F modified capsule tension rings because it requires a larger incision for implantation. Thirty one (48.4%) of the 64 patients were implanted with the 67B device.)|Preoperatively and 3 months postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms, for whom simultaneous corneal transplantation was not performed, and in whom endothelial cell counts could be obtained preoperatively and postoperatively.|||Participants|||Count of Participants
1455309|NCT00812708|Secondary|Change in Glare Sensitivity Under Night Time Lighting Conditions (Secondary Efficacy Measure)|Another secondary efficacy measure of the study was night time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.|Preoperatively and 3 months postoperatively||||Participants|||Count of Participants
1455310|NCT00812708|Secondary|Change in Glare Sensitivity Under Day Time Lighting Conditions (Secondary Efficacy Measure)|A secondary efficacy measure of the study was day time glare disability as assessed by subjective questionnaire. Glare disability was rated using a 0 to 10 scale, where 0 was considered very slight and 10 was considered very significant.|Preoperatively and 3 months postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
1455311|NCT00812708|Primary|Change in Best Corrected Visual Acuity (Primary Safety Measure)|The primary safety measure of the study was the change in best corrected distance visual acuity (CDVA) as measured using a Snellen eye chart. A ≥ 2 line improvement in Snellen CDVA following Morcher device implantation was considered a positive clinical change (visual acuity better). A ≥ 2 line worsening of Snellen CDVA following Morcher device implantation was considered a negative clinical change (visual acuity worse). A change of < 2 lines was considered to be a neutral change (visual acuity the same).|Preoperatively and 1 year postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
1455312|NCT00812708|Primary|Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)|The primary efficacy measure of the study was the change in corrected distance visual acuity (CDVA) under glare conditions. A transilluminator light was held just in front of the distance corrected study eye in one of four quadrants (above, below, nasal, or temporal) to the line of sight to evoke a glare response. The direction that produced the worst CDVA was called the CDVA with glare. A ≥ 2 line improvement in Snellen CDVA with glare following Morcher device implantation was considered a positive clinical change (glare sensitivity better). A ≥ 2 line worsening of Snellen CDVA with glare following Morcher device implantation was considered a negative clinical change (glare sensitivity worse). A change of < 2 Snellen lines following Morcher device implantation was considered to be a neutral change (glare sensitivity the same).|Preoperatively and 1 year postoperatively|This group consisted of all patients implanted with Morcher iris diaphragms.|||Participants|||Count of Participants
1455313|NCT00812604|Secondary|The Mandibular Function.|The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.|4 weeks||||mm||Standard Deviation|Mean
1455314|NCT00812604|Primary|The Efficacy in the Treatment of TMJ and Muscle Pain|"The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).~The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as “no pain ( 0 mm) and  worst pain possible ( 100 mm)."|4 weeks||||units on a scale||Standard Deviation|Mean
1455342|NCT00812461|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS|||units on a scale||Standard Error|Mean
1455315|NCT00812565|Secondary|Left and Right Hippocampal Cerebral Glucose Metabolism at Baseline and at Week 24|Cerebral glucose metabolism was measured in validated 3 dimensional statistic surface projection analysis (Cortex ID®, GE Healthcare), transversal/coronal/sagittal-slice analysis (HERMES BRASS), and voxel-wise whole brain analysis (SPM5) using [18F]fluorodeoxyglucose positron emission tomography.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||µCi/mL||Standard Deviation|Mean
1455316|NCT00812565|Secondary|Change From Screening in Whole Brain and Hippocampal Volume at Week 12 and Week 24|The volume of the whole brain and of the left and right hippocampus was measured using high-resolution structural coronal 3D heavily T1-weighted gradient-echo sequence magnetic resonance imaging. All evaluations were done centrally by Professor Frederik Barkhof at the Image Analysis Centre, VU Medical Center, Amsterdam, Netherlands. A negative change score indicates loss of brain volume.|Screening to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||cm^3||Standard Deviation|Mean
1455317|NCT00812565|Secondary|Change From Baseline in the Clinical Dementia Ratio, Sum of Boxes (CDR-SOB) Score at Week 12 and Week 24|A semi-structured interview was conducted by a physician, neuropsychologist, psychometrician, or certified study coordinator with the patient and a caregiver. Based on the results of the interview, the patient was rated on 6 domains of cognition and function: Memory, orientation, judgment/problem solving, community activities, home and hobbies, and personal care. Each domain is rated from 0 = no dementia; 0.5 = questionable dementia, mild cognitive impairment; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia. The total score ranges from 0 to 18 with a higher score indicating more dementia. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1455318|NCT00812565|Secondary|Change From Baseline in the Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADAS-ADL) Score at Week 12 and Week 24|The ADAS-ADL consists of 23 questions that measure the ability of a person to perform basic activities of daily living, such as eating, walking, bathing, grooming, and dressing. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 78 with a lower score indicating more impaired ability. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1455319|NCT00812565|Secondary|Change From Baseline in the Alzheimer’s Disease Assessment Scale, Cognitive Part (ADAS Cog) Score at Week 12 and Week 24|The ADAS cog consists of 11 items that assess cognitive areas that are often impaired in Alzheimer’s disease, specifically learning (word list), naming (objects), following commands (1 to 5 elements), ideational praxis (mail a letter), constructional praxis (copy 4 figures), orientation (person, time and place), recognition memory (from a second word list), and remembering test instructions (from the recognition subtest). The test includes 3 additional subjective scales that assess spoken language ability, word finding difficulty, and comprehension. The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 to 70 with a higher score indicating greater cognitive impairment. A negative change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1455320|NCT00812565|Secondary|Change From Baseline in the Mini Mental Status Examination (MMSE) Score at Week 12 and Week 24|The MMSE test contains 30 questions that assess 8 cognitive domains (orientation to time, orientation to place, registration, attention and calculation, recall, language, repetition, and complex commands). The test is administered by a neuropsychologist, psychometrician, or certified study coordinator. The total score ranges from 0 (severe impairment) to 30 (no impairment), with a higher score indicating a better mental status. A positive change score indicates improvement.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1455321|NCT00812565|Secondary|Change From Baseline in Tau and Phosphorylated Tau in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining tau and phosphorylated tau in cerebral spinal fluid were processed at a central laboratory using commercially available kits from Innogenetics NV (INNOTEST® hTau Ag, INNOTEST PHOSPHO-TAU (181P); Gent, Belgium). To measure phosphorylated tau, tau phosphorylated at threonine 181 (pTau181) was determined.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
1455322|NCT00812565|Secondary|Change From Baseline in Anti-Aβ Autoantibodies in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||RTU||Standard Deviation|Mean
1455323|NCT00812565|Secondary|Change From Baseline in Aβ1-40 and Aβ1-42 in Cerebral Spinal Fluid 24-48 Hours After the Last Infusion|Samples for determining Aβ1-40 and Aβ1-42 in cerebral spinal fluid were processed at a central laboratory using a commercially available kit from Meso Scale Discovery (MSD 96-Well Multi-Spot Human/Rodent (4G8) Abeta Triplex Ultra-Sensitive Assay; Rockville, MD, USA).|Baseline to Week 23 Day 2 for participants who received infusions every 2 weeks and Baseline to Week 21 Day 2 for participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
1455324|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Anti-Aβ Autoantibodies in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||RTU*days||Standard Deviation|Mean
1455325|NCT00812565|Secondary|Change in the Area Under the Curve of Plasma Aβ1-42 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||(pg/mL)*days||Standard Deviation|Mean
1455326|NCT00812565|Secondary|Change in Plasma Concentration of Anti-Aβ Autoantibodies From Baseline to the End of the Study (Week 24)|Samples for determining anti-Aβ autoantibodies in blood plasma were processed at a central laboratory using a commercially available kit from DRG Instruments GmbH, (EIA-5099; Marburg, Germany) using methods established at the Department of Neurology, Philipps-University, Marburg, Germany (Professor Dr. med. Richard Dodel). The kit includes 6 standard concentrations of anti-Aβ antibody against which the results of the assay are compared. The standards contain 1, 5, 15, 30, 60, and 120 Relative Units (RTU) which contain 0.03, 0.17, 0.5, 1, 2, and 4 mg IgG/mL, respectively.|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||RTU||Standard Deviation|Mean
1455327|NCT00812565|Secondary|Change in Plasma Concentration of Aβ1-40 and Aβ1-42 From Baseline to the End of the Study (Week 24)|Samples for determining Aβ1-40 and Aβ1-42 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Baseline to Week 24|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
1455328|NCT00812565|Primary|Change in the Area Under the Curve of Plasma Aβ1-40 in the 2 or 4 Weeks After the Last Treatment Infusion From the Trough Level Prior to the Last Treatment Infusion|For participants who received infusions every 2 weeks, plasma samples were collected at the trough level at Week 22 and on Days 1, 4, 7, and 14 after Week 22. For participants who received infusions every 4 weeks, plasma samples were collected at the trough level at Week 20 and on Days 1, 4, 7, 14, 21, and 28 after Week 20. Samples for determining Aβ1-40 in blood plasma were processed at a central laboratory using a commercially available kit from Innogenetics NV (INNO-BIA plasma Aβ forms; Gent, Belgium).|Week 22 to Week 24 for participants who received infusions every 2 weeks and Week 20 to Week 24 participants who received infusions every 4 weeks|Full analysis set: All randomized participants who received at least 1 infusion of the study medication and had at least 1 post-baseline efficacy assessment. Only participants with available data were included in the analysis.|||(pg/mL)*days||Standard Deviation|Mean
1455329|NCT00812487|Secondary|Mean Glucose|mean sensor glucose|24 hours||||mg/dl||Standard Deviation|Mean
1455330|NCT00812487|Secondary|Coefficient of Variation (CV)|CV is a measure of glycemic variability|24 hours||||percentage (mean glucose/SD)||Standard Deviation|Mean
1455331|NCT00812487|Primary|Hospital Readmission|All-cause hospital readmission within 30 days|30 days||||participants|||Number
1455332|NCT00812487|Primary|Hospital Length of Stay|Duration of hospitalization|participants were followed for the duration of hospital stay, median hospital stay 8 day||||days||Inter-Quartile Range|Median
1455333|NCT00812487|Secondary|Glycemic Lability Index (GLI)|GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements|24 hours||||(mg/dl)^2/hr*day-1||Inter-Quartile Range|Median
1455334|NCT00812487|Secondary|Quality of Life|Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).|30 days||||units on a scale||Inter-Quartile Range|Median
1455345|NCT00812461|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.|||days||Standard Error|Mean
1455346|NCT00812331|Secondary|Terminal Elimination Half-life (t1/2,Term) of TMC435|The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection. The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||hours||Full Range|Median
1455347|NCT00812331|Secondary|Elimination Rate Constant of TMC435|In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||1/hour||Full Range|Median
1455348|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435|The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng*h/mL||Full Range|Median
1455349|NCT00812331|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435|The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - as all randomized participants who received at least 1 dose of study medication (TMC435).|||ng*h/mL||Full Range|Median
1455350|NCT00812331|Secondary|Fluctuation Index (FI) of TMC435|The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||% fluctuation||Full Range|Median
1455351|NCT00812331|Secondary|Average Steady-State Plasma Concentration (Css,av) of TMC435|The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
1455352|NCT00812331|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435|The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||hours||Full Range|Median
1455353|NCT00812331|Secondary|Maximum Plasma Concentration (Cmax) of TMC435|The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
1455354|NCT00812331|Secondary|Minimum Plasma Concentration (Cmin) of TMC435|The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.|Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
1455355|NCT00812331|Secondary|Predose Plasma Concentration (C0h) of TMC435|The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.|Predose on Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||ng/mL||Full Range|Median
1455356|NCT00812331|Secondary|Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period|The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.|During the 7-day of TMC435 treatment period|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||Participants|||Number
1455357|NCT00812331|Secondary|Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period|The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population - all randomized subjects who received at least 1 dose of study medication (TMC435)|||Participants|||Number
1455358|NCT00812331|Secondary|Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period|The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.|Baseline, Day 3, Day 5 and Day 7|Intent-to-treat (ITT) Population- all randomized subjects who received at least 1 dose of study medication (TMC435)|||Participants|||Number
1455359|NCT00812331|Primary|Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels|The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.|Baseline, Day 3, and Day 7|Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).|||log10 IU/mL||Standard Error|Mean
1455360|NCT00812253|Secondary|Cardiac Output|Cardiac output measured using impedance cardiography at 72 hours.|72 hours|Patients without data due to medical devices, conditions that preclude measurement of PEP such as arrhythmias, or technical problems.|||liter/min||Standard Deviation|Mean
1455361|NCT00812253|Secondary|Brain Natriuretic Peptide (BNP)|Brain natriuretic peptide (BNP) was measured at day 3|72 hours||||pg/ml||Inter-Quartile Range|Median
1455362|NCT00812253|Secondary|Change in Quality of Life|Change in Quality of Life questionnaire measured from baseline (enrollment) to 30 days following discharge. The questionnaire is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on health related quality of life, from 0 (none) to 5 (very much). It provides a total score (range 0–105, from best to worst HRQoL),|30 day||||units on a scale||Standard Deviation|Mean
1455363|NCT00812253|Secondary|Heart Rate Variability|High frequency (HF) Heart rate variability (HRV). HRV was assessed with a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration and impedance cardiography was performed using a standard tetrapolar arrangement. Measures were performed at baseline and each morning (0800-1000 hour) during and following the intervention for 7 minutes each. Software (Mindware, Gahanna, OH) was used to derive HF HRV. The middle five minutes of the recordings were scored minute by minute and the first suitable1 minute period was used for calculation. Five minute epochs were not feasible due to an unexpectedly high frequency of ectopy. One minute intervals allow calculation of HF (parasympathetic tone) but not low frequency (combination of sympathetic and parasympathetic tone).|72 hours|Subjects with medical devices, conditions that preclude measurement of HRV such as arrhythmias, or technical problems could not be analyzed.|||ms^2||Inter-Quartile Range|Median
1455364|NCT00812253|Secondary|Hospital Readmission|All-cause hospital readmission at 30 days after discharge|30 days||||participants|||Number
1455365|NCT00812253|Primary|Hospital Length of Stay|Duration of hospitalization in days|Days||||days||Inter-Quartile Range|Median
1455366|NCT00812110|Primary|Number of Participants Who Received Influenza Vaccine.|Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination|1 hour||||participants|||Number
1455367|NCT00812110|Secondary|Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?|Number of participants who received influenza vaccine the prior year.|16 months||||participants|||Number
1455368|NCT00812097|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects are included.|||inches||Standard Deviation|Mean
1455369|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1455370|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1455371|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1455372|NCT00812097|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
1455373|NCT00812006|Secondary|Treatment Satisfaction (TS)|Patient satisfaction was assessed on a paper diary by the participants. Level of satisfaction was rated as: completely satisfied, very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied. The overall 24-hour assessment of study medication was dichotomized to Satisfaction (completely satisfied, very satisfied, somewhat satisfied) and Non-satisfaction (neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied, or completely dissatisfied) for analysis.|24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and post-dose satisfaction measurement at the 24-hour time point.|||Attacks|||Number
1455374|NCT00812006|Secondary|Normal Rating of Functional Disability (NRFD)|Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired, or unable to do activities, requires bedrest. Functional disability ratings was dichotomized to Normal and Not Normal (mildly impaired, severely impaired, or unable to do activities, requires bedrest) for analysis.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.|||Attacks|||Number
1455375|NCT00812006|Secondary|Pain Freedom (PF)|Headache pain severity, relative to the administration of study medication, was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain freedom (PF) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 0 (no pain) post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.|||Attacks|||Number
1455376|NCT00812006|Secondary|Sustained Pain Relief (SPR)|24-hour sustained pain relief (defined as pain relief at 2 hours post dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the respective period after dosing with the blinded study medication.|2 - 24 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the attack must have met the FAS criteria for PR at 2 hours post-dose, and from 2-24 hours the participant either answered 24-hour headache recurrence question or didn't have PR at any time or took rescue.|||Attacks|||Number
1455377|NCT00812006|Primary|Pain Relief (PR)|Pain severity was rated by the participants in a paper diary. Pain severity rating scale : 0 (no pain), 1 (mild pain), 2 (moderate pain), or 3 (severe pain). Pain relief (PR) is defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 post dose.|2 hours post dose|Full Analysis Set, which included all randomized participants who had at least one evaluable attack. To be considered an evaluable attack, the participant must have administered study treatment for this attack and have both a baseline severity measurement and at least one post-dose efficacy measurement at or prior to the 2-hour time point.|||Attacks|||Number
1455378|NCT00811954|Secondary|Self-reported Adherence|Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144.|At Weeks 4, 24, 48, 96, and 144|Intention to treat: All participants with fasting self-reported adherence data were included.|||percentage of prescribed medication||95% Confidence Interval|Mean
1455379|NCT00811954|Secondary|Change in Waist:Height Ratio From Baseline|Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.|||cm:cm||95% Confidence Interval|Mean
1455380|NCT00811954|Secondary|Change in Waist Circumference From Baseline|Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with waist circumference data were included, complete-case approach.|||cm||95% Confidence Interval|Mean
1455381|NCT00811954|Secondary|Change in Framingham 10-year Risk of MI or Coronary Death From Baseline|"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk."|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||percent risk||95% Confidence Interval|Mean
1455382|NCT00811954|Secondary|Change in Fasting Plasma Glucose Level From Baseline|Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
1455383|NCT00811954|Secondary|Change in Fasting Triglycerides Level From Baseline|Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
1455384|NCT00811954|Secondary|Change in Fasting HDL Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
1455385|NCT00811954|Secondary|Change in Fasting Total Cholesterol Level From Baseline|Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol.|Study entry to weeks 48, 96, and 144|Intention to treat: All participants with fasting lipids data were included, complete-case approach.|||mg/dL||95% Confidence Interval|Mean
1455414|NCT00811928|Secondary|Number of Participants in Whom All-cause Mortality Occurred Within 100 Days From Randomization|Death from any cause.|Randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
1455386|NCT00811954|Secondary|Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)|The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||events per 100 person-years||95% Confidence Interval|Number
1455387|NCT00811954|Secondary|Incidence of Death or AIDS Defining Events (CDC Category C)|The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.|Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||events per 100 person-years||95% Confidence Interval|Number
1455388|NCT00811954|Secondary|CD4+ T-cell Count Changes From Baseline|Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count|Study entry to weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||cells/mm^3||95% Confidence Interval|Mean
1455389|NCT00811954|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm3)|At Weeks 24, 48, 96, and 144|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||cells/mm^3||95% Confidence Interval|Mean
1455390|NCT00811954|Secondary|Presence of Mutations Associated With INI Resistance|The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure restricted to participants in the RAL group and random sample of participants in PI/RTV groups with successful sequencing at virologic failure.|||participants|||Number
1455391|NCT00811954|Secondary|Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance|The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure|||participants|||Number
1455392|NCT00811954|Secondary|Presence of Mutations Associated With NRTI Resistance|The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.|At the virologic failure at any time throughout the study (up to 213 weeks)|Participants who met the criteria for virologic failure with successful sequencing at virologic failure|||participants|||Number
1455393|NCT00811954|Secondary|Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96|"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
1455394|NCT00811954|Secondary|Cumulative Incidence of First Adverse Event by Week 96|"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up."|From study entry to week 96|As treated: Participants who had events occurring while on randomized treatment are included in this analysis: grade 2 events occurring in the after 48 weeks on study are excluded. Participants were analyzed per original assigned randomized treatment.|||cumulative events per 100 persons||95% Confidence Interval|Number
1455395|NCT00811954|Primary|Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96|The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative events per 100 persons||95% Confidence Interval|Number
1455396|NCT00811954|Primary|Cumulative Probability of First Virologic Failure by Week 96|"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry."|From study entry to week 96|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
1455397|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 52|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455398|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 52|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455399|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 52|FAS|||units on a scale||Standard Error|Mean
1455400|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 52|FAS|||units on a scale||Standard Error|Mean
1455401|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 13|FAS|||percentage of participants|||Number
1455402|NCT00811941|Secondary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 13|FAS|||g||Standard Error|Mean
1455403|NCT00811941|Secondary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women.|Baseline and Month 13|FAS|||days||Standard Error|Mean
1455404|NCT00811941|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455405|NCT00811941|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455406|NCT00811941|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS|||units on a scale||Standard Error|Mean
1455407|NCT00811941|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS|||units on a scale||Standard Error|Mean
1455408|NCT00811941|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS|||percentage of participants|||Number
1455409|NCT00811941|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS|||g||Standard Error|Mean
1455410|NCT00811941|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) - all patients in the APTS who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.|||days||Standard Error|Mean
1455411|NCT00811941|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|All-patients-treated Set (APTS)|||percentage of participants|||Number
1455412|NCT00811941|Primary|Number of Patients With Adverse Events (AEs)|Overview of AEs|Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks.|All-patients-treated set (APTS) – all patients in the APRS excluding those with no recorded investigational medicinal product (IMP) intake and all IMP returned|||participants|||Number
1455413|NCT00811928|Secondary|Number of Participants in Whom Mortality is Unlikely, Possibly, and Probably Related to Fungal Infection Occurred Within 100 Days From Randomization|"Exact Causes of Death and Their Relationship to IFI Episode Were As Follows:~Unlikely related: participant completed treatment and cause of death was due to primary disease or complication~Possibly related: IFI undergoing treatment without stabilization, or with failure to have a complete remission, where cause of death might have been due to IFI, including progression or relapse of primary disease~Probably related: autopsy or clinical signs suggested that progression of IFI was the probable cause of death"|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
1455415|NCT00811928|Secondary|Number of Participants With Clinical Failure During Treatment|"Clinical failure was defined as follows:~Presence of a proven or probable IFI~Systemic antifungal treatment (IV) for 4 consecutive days or more than 10 days total~Discontinuation due to adverse event (AE) possibly or probably related to study drug~Lost-to-follow-up or discontinuation from the study for any reason with loss to follow-up during the Treatment Phase"|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
1455416|NCT00811928|Secondary|Time From Randomization to Administration of First Systemic Antifungal Intravenous (IV) Therapy|The time measured in days from randomization to the administration of the first concomitant systemic anti-fungal therapy in the entire FAS population. Not all participants who accepted systemic anti-fungal therapy may have had a IFI clinical diagnosis. IFI diagnosis criteria for antifungal therapy administration may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 weeks (84 days)|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||Days|||Number
1455417|NCT00811928|Secondary|Time From Randomization to the First Onset of Proven or Probable IFI|The time measured in days to the first occurrence of proven/probable IFI diagnosis in the entire FAS population from randomization to Day 100 of follow-up visit. Participants may not have accepted immediate antifungal treatment and later received antifungal treatment based upon further investigator review of the participant's IFI condition. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, positive blood/biopsy cultures with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||Days|||Number
1455418|NCT00811928|Secondary|Number of Participants With Proven or Probable Diagnosis of IFI Within 100 Days From Randomization|Number of participants who developed a proven or probable IFI from randomization date to Day 100 of follow-up visit. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|From randomization date to Day 100|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
1455419|NCT00811928|Primary|Number of Participants With Proven or Probable Diagnosis of Invasive Fungal Infection (IFI) During the Treatment Period|Number of participants developing a proven or probable IFI from randomization to the last dosage date (up to 12 weeks [84 days]) plus 7 days. IFI diagnosis criteria may include: persistent fever, failure of appropriate broad-spectrum antibiotic treatment concomitant with lower respiratory tract infection symptoms, microbiological criteria with corresponding clinical signs and symptoms.|Up to 12 Weeks (84 days) plus 7 days|The full analysis set (FAS) included all of those randomized participants who received at least one dose of study drug, and had at least one post-treatment follow-up data of primary efficacy variable.|||participants|||Number
1455420|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455421|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455422|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455423|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455424|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455425|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455426|NCT00811850|Primary|Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455427|NCT00811850|Primary|Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery|Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).|1 Month|Intent-to-treat population, which consisted of all patients that started the study (randomized)|||Centimeters per second (cm/s)||Standard Deviation|Mean
1455428|NCT00811798|Primary|Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the entire study period (Day 0 up to the telephone contact at Month 12).||||Subjects|||Number
1455429|NCT00811733|Secondary|Number of Participants With the Indicated Infusion-related >=Grade 3 AE|Infusion-related AEs are the AEs that resulted from administration of study drug through infusion. AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced >=Grade 3 infusion-related AEs were assessed.|||participants|||Number
1455430|NCT00811733|Secondary|Number of Participants With the Indicated >=Grade 3 AEs|AEs were graded using the Common Toxicity Criteria for AEs from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a >=Grade 3 AE were assessed.|||participants|||Number
1455431|NCT00811733|Secondary|Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Drug and Withdrawal From Study|Certain AEs led to permanent discontinuation of study drug and hence resulted in their withdrawal from the study.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an AE leading to their withdrawal from the study were assessed.|||participants|||Number
1455432|NCT00811733|Secondary|Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study drug.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced a study drug-related AE were assessed.|||participants|||Number
1455433|NCT00811733|Secondary|Number of Participants With the Indicated SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|From baseline up to approximately 5 years|Safety Population. Only those participants who experienced an SAE categorized as being related to study drug were assessed.|||participants|||Number
1455434|NCT00811733|Secondary|Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment|CD4+ and CD19+ are two key flow cytometry parameters, and total hemolytic complement (CD50) is a complement parameter. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Month 3|ITT Population: only participants with blood count data at both Baseline and Month 3 were included in the analysis.|||cells per microliter (µL)||Full Range|Median
1455435|NCT00811733|Secondary|Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result|All human-antihuman antibody (HAHA) samples were first tested in a screening assay to identify potential HAHA positives. Next, samples that tested positive in the screening assay were further tested in the confirmation assay to determine the specificity of the signal to ofatumumab. Confirmed positive samples were reported as positive.|From baseline up to approximately 5 years|Safety Population. Only those participants with post-ofatumumab HAHA results were analyzed.|||participants|||Number
1455504|NCT00811317|Secondary|Set Point Using CGM Data as the Input to the Controller for Future Studies|The algorithm in the Bionic Pancreas must have a pre-specified target glucose it is trying to achieve in order to make dosing decisions. Using data from this study, investigators planned to determine what an appropriate glucose target should be for future studies.|24 hours||||mg/dl|||Number
1455436|NCT00811733|Secondary|AUC(0-tau) and AUC(0-inf) of Ofatumumab|AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be calculated..|||micrograms X hours/milliliters (µg.h/mL)||95% Confidence Interval|Geometric Mean
1455437|NCT00811733|Secondary|Cmax and Ctrough of Ofatumumab|Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be determined.|||micrograms/milliliter (µg/ml)||95% Confidence Interval|Geometric Mean
1455438|NCT00811733|Secondary|Half-life of Ofatumumab|Half-life (t½) is defined as the time required for the concentration of the drug in plasma to decrease to one-half of its current value. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.|||Days (d)||95% Confidence Interval|Geometric Mean
1455439|NCT00811733|Secondary|Volume of Distribution at Steady State of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of the drug in the body at steady state. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|PK Population. Data were provided for the number of participants for whom the parameter could be determined.|||Liters (L)||95% Confidence Interval|Geometric Mean
1455440|NCT00811733|Secondary|Clearance of Ofatumumab|Clearance (CL) is defined as the volume of plasma that is cleared of drug per unit of time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.|From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7|Pharmacokinetic (PK) Population: all participants from whom a PK sample was obtained and analyzed. Data were provided for the number of participants for whom the parameter could be determined.|||milliliters/hour (ml/hr)||95% Confidence Interval|Geometric Mean
1455441|NCT00811733|Secondary|Overall Survival|Overall survival is defined as the time from baseline until death due to any cause.|From baseline up to approximately 5 years|ITT Population. Only those participants who died during the study and during the follow-up period were assessed.||||||
1455442|NCT00811733|Secondary|Time to Response for Responders|Time to response is defined as the time from baseline to the first response date.|From baseline up to approximately 5 years|ITT Population. Only participants classified as responders (CR, PR, and MR) were assessed.|||days||95% Confidence Interval|Median
1455443|NCT00811733|Secondary|Progression-free Survival|Time to disease progression is defined as the time from baseline to disease progression or death.|From baseline up to approximately 5 years|ITT Population. Participants who experienced disease progression or death were counted as events, and other participants were censored at the time of the last adequate assessment in the study.|||days|events|Inter-Quartile Range|Median
1455444|NCT00811733|Secondary|Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator|Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node >=1.5 centimeters on any axis. Progression for PR/MR is either a >=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM.|From baseline up to approximately 5 years|ITT Population. Only those participants classified as responders were included in the analysis. Participants who had disease progression or death were counted as events, and other participants were censored at the date of the last adequate assessment in the study.|||days|events|Inter-Quartile Range|Median
1455445|NCT00811733|Secondary|Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)|IgM is a basic antibody that is produced by B cells. It is the first antibody to appear in response to initial exposure to antigen. IgM flare is defined as an IgM level that increases by >25% from baseline (BL) and is associated with a response to treatment. Avoidance of IgM flare indicates the lack of an increase in IgM of >25% from BL.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population. Only those participants who received Cycle 1 treatment (including the Redosing Cycle) were assessed.|||participants|||Number
1455446|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population|||participants|||Number
1455512|NCT00811317|Secondary|Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data||24 hours|Navigator CGM data from the day prior to admission was not obtained||||||
1455447|NCT00811733|Secondary|Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|ITT Population|||participants|||Number
1455448|NCT00811733|Primary|Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to Study Week 16|ITT Population|||participants|||Number
1455449|NCT00811733|Primary|Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator|OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a >=50% reduction from baseline in the SM IgM concentration. MR: >=25%, but a <50% reduction of SM IgM from baseline.|Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment|Intent-to-Treat (ITT) Population: all participants who were considered eligible for treatment and who had been exposed to study drug irrespective of the planned course of treatment.|||participants|||Number
1455450|NCT00811720|Secondary|Liver Function Test Alanine Aminotransferase (ALAT)|ALAT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455451|NCT00811720|Secondary|Liver Function Test Gamma-glutamyl Transferase (GGT)|GGT values|Week 24|FAS|||IU/L||Geometric Coefficient of Variation|Geometric Mean
1455452|NCT00811720|Secondary|Change in Clinical Status Using the CGI-I|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Week 24|FAS|||units on a scale||Standard Error|Mean
1455453|NCT00811720|Secondary|Change From Baseline in Clinical Status Using CGI-S|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|FAS|||units on a scale||Standard Error|Mean
1455454|NCT00811720|Secondary|Drinking Risk Level (RSDRL) Response|RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.|Month 6|FAS|||percentage of participants|||Number
1455455|NCT00811720|Primary|Change From Baseline in the Monthly Total Alcohol Consumption (TAC)|TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).|Baseline and Month 6|FAS|||g||Standard Error|Mean
1455456|NCT00811720|Primary|Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs)|Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.|Baseline and Month 6|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline.|||days||Standard Error|Mean
1455457|NCT00811655|Secondary|Overall Survival (OS)|Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|24 months after SRS|Intent-to-treat|||Months||95% Confidence Interval|Median
1455458|NCT00811655|Secondary|Number of Patients Who Died Due to Neurological Causes|Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.|Within 24 months post-SRS|Intent-to-treat|||participants|||Number
1455459|NCT00811655|Secondary|Clinical Significance of Locally Recurrent Brain Metastases|Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.|24 months post-SRS|There are no patients for this analysis because none had a local recurrence.||||||
1455460|NCT00811655|Secondary|Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)|Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.||||||
1455505|NCT00811317|Secondary|Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard|Mean absolute relative difference (MARD) of CGM and BG glucose readings in hypoglycemia (< 70 mg/dl) and hyperglycemia (>180 mg/dl) in three different CGM devices: Dexcom, Navigator and Guardian|24 hours||||percent absolute difference||Standard Deviation|Mean
1455506|NCT00811317|Secondary|Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects||24 hours|This outcome was not analyzed. There were no open loop experiments in diabetic subjects that we were able to make a comparison with||||||
1455461|NCT00811655|Secondary|Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)|Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.|Administered at baseline and every 3 months post-SRS|Data for this outcome was erroneously not gathered.||||||
1455462|NCT00811655|Secondary|Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site|Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.|||participants|||Number
1455463|NCT00811655|Secondary|Volume of Adjacent Normal Brain Parenchyma Irradiated|Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).|At time of SRS|Data for this outcome was not collected.||||||
1455464|NCT00811655|Secondary|Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery|Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery|Within 24 months post-SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.|||participants|||Number
1455465|NCT00811655|Primary|Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)|Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI’s for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).|Within 12 months after SRS|Intent-to-treat; 1 patient was not included in this analysis as they were unable to undergo surgery after SRS.|||Participants|||Number
1455466|NCT00811642|Primary|Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 12|Pool of participants were from the Full Analysis Set (FAS): included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Participants|||Number
1455467|NCT00811642|Secondary|Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up|Total number of participant deaths was assessed at the end of 2 week post-treatment follow-up (14 weeks). The total number of deaths was compared to the number of survivors at baseline.|Follow-up week 14|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Participants|||Number
1455468|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 12|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.|||Participants|||Number
1455469|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 8|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. LOCF was used for missing data.|||Participants|||Number
1455470|NCT00811642|Secondary|Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment|"EVALUATION OF FUNGAL ERADICATION:~Participants' mycological response to therapy was assessed by the following:~Eradication: Negative culture or histologically documented absence of infecting~fungal pathogen from a primary site previously positive.~Presumed Eradication: Resolution of all IFI attributable symptoms, signs and laboratory or radiological abnormalities in which a repeat culture/biopsy was contraindicated.~Persistence: Continued isolation of fungal pathogen from a primary site previously positive or cytological documentation of presence of fungal pathogen."|Treatment week 4|Only FAS participants with positive fungal culture (of suspected site or blood) were evaluated. Last Observation Carried Forward (LOCF) was used for missing data.|||Participants|||Number
1455507|NCT00811317|Secondary|Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects||24 hours|This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with||||||
1455513|NCT00811317|Secondary|Blood Glucagon Levels||24 hours||||microgram/kg||Standard Deviation|Mean
1455471|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 8|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Participants|||Number
1455472|NCT00811642|Secondary|Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment|"EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA:~Complete Response: resolution of IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment.~Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession.~Stable disease: no progress in IFI attributable symptoms, if present at enrollment.~Failure: deterioration in IFI attributable clinical symptoms."|Treatment week 4|Pool of participants were from the FAS: included all randomized participants who received at least one dose of study drug and who had valid data of primary efficacy endpoint for at least one follow-up visit after treatment. Did not include the 3 participants from the SS population (n=62) who withdrew from the study.|||Particpants|||Number
1455473|NCT00811590|Primary|The Size of Intestinal Polyps||24 months|Due to small enrollment number, analysis was not possible.||||||
1455474|NCT00811577|Secondary|Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. For exploratory purposes, the specimens were blindly scored in duplicate by a dermal pathologist for the estimated number of alpha-smooth muscle actin (α-SMA) positive cells per high powered field. Values ranged from 0 to several hundred. The number of α-SMA cells was assessed for exploratory purposes; therefore, at the time of this report, it was not known whether it was better to have a low or high α-SMA score.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Cells per high-powered field||Standard Deviation|Mean
1455475|NCT00811577|Secondary|Histological Evaluation of Collagen|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. The specimens were blindly scored in duplicate by a dermal pathologist for dermal collagen fiber density, maturity and orientation, where 0% was completely normal and 100% was completely abnormal.|12 months|This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Percent||Standard Deviation|Mean
1455476|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm, or AZX100 10 mg/cm, or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate positive volume, negative volume, and total volume in millimeters cubed (mm^3) at 12 months. Positive volume included the scar volume that was calculated to be above the interpolated smooth skin surface. A smaller value was preferred. Negative volume included the volume of the scar calculated to be below the interpolated smooth skin surface. It was always a negative number; negative values (closer to zero) were more desirable. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Millimeters cubed||Standard Deviation|Mean
1455477|NCT00811577|Secondary|Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)|Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate scar length, width, minimum elevation, and maximum elevation in millimeters (mm) at 12 months. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface. This was always a negative number. Negative values (closer to zero) were more desirable. The maximum elevation value was the highest point of the scar above the interpolated smooth skin surface. A smaller value was preferred.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Millimeters||Standard Deviation|Mean
1455491|NCT00811395|Primary|Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase [ALT] >3, 5, 10 or 20 Upper Normal Limit [ULN];~Aspartate aminotransferase [AST] >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin [TB] >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN;"|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1455478|NCT00811577|Secondary|Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography|Three trocar sites were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or saline placebo/cm at 9 days and 21 days after surgery. Twelve months after surgery, images of the trocar sites were longitudinally evaluated and rated using a standard 100 mm Visual Analog Scale (VAS) by two blinded independent dermatologists, with 0 being normal skin and 100 being the worst scar imaginable. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100 and placebo and 10 mg AZX100 for each of the two raters separately. Data from both raters was not combined.|12 months|Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the VAS outcome, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12).|||Millimeters||Standard Deviation|Mean
1455479|NCT00811577|Primary|Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores|Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.|12 months|The efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including the patients receiving placebo-only). In the ITT sample for the POSAS outcomes, available sample sizes were 122 at Day 42 and 113 at Month 12 (including 4 subjects who withdrew from the study but were still followed for safety until Month 12).|||Units on a scale||Standard Deviation|Mean
1455480|NCT00811564|Primary|Intraocular Pressure (IOP) at Week 12|Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Intent-to-treat, which included all patients who started the study (randomized).|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
1455481|NCT00811473|Secondary|The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness|The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of “Much” or “Very much” improved in overall bipolar illness assessment.|Day 57||||Proportions|||Number
1455482|NCT00811473|Secondary|CGI-BP-C Score at Final Assessment (Day 57)|The CGI-BP-C scale rates how much the patient’s illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement.|Change from Baseline to day 57||||Scores on a scale||Standard Error|Least Squares Mean
1455483|NCT00811473|Secondary|Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S|The CGI-BP-S scale rates the severity of the patient’s illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.|Change from Baseline to Day 57||||Scores on a Scale||Standard Error|Least Squares Mean
1455484|NCT00811473|Secondary|The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score|The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57||||participants|||Number
1455485|NCT00811473|Secondary|Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).|The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).|Days 8 to 57||||participants|||Number
1455486|NCT00811473|Primary|Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)|Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).|Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57||||Scores on a scale||Standard Error|Least Squares Mean
1455487|NCT00811434|Secondary|Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function|MHE as measured by failure of one or more cognitive test|before and after each treatment period|data not collected as planned||||||
1455488|NCT00811434|Secondary|Health Related Quality of Life (HRQOL)|HRQOL administered to parents prior to treatment|baseline|data not collected as planned||||||
1455489|NCT00811434|Primary|Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis|failure of one cognitive function test indicates presence of MHE|baseline||||participant|||Number
1455490|NCT00811395|Secondary|Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan|Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters per scan|||Number
1455502|NCT00811382|Primary|Days Lost|Clinical composite outcome based on the days lost due to cardiovascluar mortality, cardiovascular hospitalization and inappropriate ICD therapy during an observational period of 12 months.|12 months||||Days lost per patient||Standard Deviation|Mean
1455503|NCT00811317|Secondary|Insulin and Glucagon Levels During Closed Loop and Open Loop Admissions of Diabetic Subjects Compared to the Comparable 24 Hour Period During the Admission of Non-diabetic Subject||24 hours|This outcome was not analyzed. There were no experiments in non-diabetic subjects that we were able to make a comparison with||||||
1455492|NCT00811395|Secondary|Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)|"Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.~To account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as offset variable and:~Model 1 (IFN-β groups): Treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates~Model 2 (GA groups): Treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||lesions per scan||95% Confidence Interval|Number
1455493|NCT00811395|Secondary|Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)|"Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.~Least-square means were estimated using two Mixed-effect models with repeated measures [MMRM] on cubic root transformed volume data:~Model 1 (IFN-β groups): treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors;~Model 2 (GA groups): treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors."|baseline (before randomization in PDY6045 or PDY6046) and 48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||mililiters (mL)||Standard Error|Least Squares Mean
1455494|NCT00811395|Secondary|Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints|"Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||percent probability||95% Confidence Interval|Number
1455495|NCT00811395|Secondary|Overview of 12-week Sustained Disability Progression|"12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks.~If no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression."|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1455496|NCT00811395|Primary|Overview of AE With Potential Risk of Occurence|"AE with potential risk of occurrence were defined as follows:~Hepatic disorders;~Immune effects, mainly effects on bone marrow and infection;~Pancreatic disorders;~Malignancy;~Skin disorders, mainly hair loss and hair thinning;~Pulmonary disorders;~Hypertension;~Peripheral neuropathy;~Psychiatric disorders;~Hypersensitivity."|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1455497|NCT00811395|Secondary|Annualized Relapse Rate [ARR]: Poisson Regression Estimates|"ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale [EDSS] score or Functional System scores.~To account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as offset variable and:~Model 1 (IFN-β groups): treatment group, region of enrollment and IFN-β dose level as covariates~Model 2 (GA groups): treatment group and region of enrollment as covariates)"|48 weeks|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||relapses per year||95% Confidence Interval|Number
1455498|NCT00811395|Primary|Overview of Adverse Events [AE]|AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)|All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.|||participants|||Number
1455499|NCT00811382|Secondary|Progression of AF and AT/AF Burden|The proportion of patients in sinus rhythm or with paroxysmal AF, persistant AF, or permanet AF at the end of the Follow-Up, without statistical evaluation and analysis of AF/AT (atrial tachycardia) burden based on the home monitoring data|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment||||||
1455500|NCT00811382|Secondary|Reverse Remodelling (LA Diameter, LVESV, Mitral Regurgitation)|Analysis of the change in left ventricular end-systolic volume, left atrial diameter, left ventricular EF, and the degree of mitral regurgitation from enrollment to the end of the follow-up in the two treatment arms|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment||||||
1455501|NCT00811382|Secondary|Heart Failure Clinical Composite Score (Packer Score)|Analysis of the fraction of patients with worsened composite clinical score in the two treatment arms.|12 months|Endpoint was not evaluated because of the insignificant result for the primary hypothesis and early study discontinuation due to low enrollment||||||
1455514|NCT00811317|Secondary|Total Glucagon Dose||24 hours||||mcg/kg||Standard Deviation|Mean
1455526|NCT00811252|Secondary|Risk of Suicidality Using C-SSRS Scores|The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with sub-questions that assess severity. The tool was administered via an interview with the patient.|Up to 8 weeks|C-SSRS Data by Columbia Classification Algorithm for Suicide Assessment (C-CASA) Category (APTS)|||participants|||Number
1455527|NCT00811252|Secondary|Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)||Week 8|FAS; LOCF|||percentage of patients|||Number
1455528|NCT00811252|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)||Week 8|FAS; LOCF|||percentage of patients|||Number
1455529|NCT00811252|Secondary|Change From Baseline in GDS Total Score After 8 Weeks of Treatment|The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.|Baseline and Week 8|FAS; observed cases (OC); ANCOVA|||units on a scale||Standard Error|Mean
1455530|NCT00811252|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1455531|NCT00811252|Secondary|Change From Baseline in CGI-S Score After 8 Weeks of Treatment|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1455532|NCT00811252|Secondary|Change From Baseline in HAM-A Total Score After 8 Weeks of Treatment|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1455533|NCT00811252|Secondary|Change From Baseline in MADRS Total Score After 8 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1455534|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment||Baseline and Week 1|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1455535|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment||Baseline and Week 2|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1455536|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment||Baseline and Week 4|FAS; LOCF; ANCOVA|||units on a scale||Standard Error|Mean
1455537|NCT00811252|Secondary|Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment||Baseline and Week 6|FAS; LOCF, ANCOVA|||units on a scale||Standard Error|Mean
1455538|NCT00811252|Primary|Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 8|Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable; last observation carried forward (LOCF); analysis of covariance (ANCOVA)|||units on a scale||Standard Error|Mean
1455539|NCT00811174|Secondary|Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)||12 months|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
1455540|NCT00811174|Secondary|Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents||before treatement 10 and 13 (of 13 or 17 treatments) and at the end|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
1455541|NCT00811174|Secondary|Pre-next-dose Levels of Serum Total IgG||before each treatment|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
1455542|NCT00811174|Secondary|Assessment of Viral Safety||Every three months|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
1455543|NCT00811174|Secondary|Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis)||at each treatment date (every three to four weeks)|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
1455544|NCT00811174|Secondary|Vital Signs||during each treatment|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
1455545|NCT00811174|Primary|Pharmacokinetics of Serum Total IgG and IgG Subclasses (IgG1, IgG2, IgG3 and IgG4) and Pharmacokinetics of Specific Antibodies Against Defined Infectious Agents Comparing Octagam 5% Treatment With Octagam 10% Treatment|Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment|after 6 months of treatment|Due to premature termination of the study, data were unavailable and no analysis was done.||||||
1455546|NCT00811174|Primary|Adverse Events|Occurrence of Adverse Events|During infusion or within 72 hours after end of infusion||||participants|||Number
1455547|NCT00811135|Secondary|Duration of Response (DR)|DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death. CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
1455548|NCT00811135|Secondary|Number of Participants With Response|Participants who had CR or PR were considered as responders. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
1455549|NCT00811135|Secondary|Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
1455550|NCT00811135|Secondary|Number of Participants With Time to Progression (TTP)|TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). TTP was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
1455551|NCT00811135|Secondary|Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment. OS was estimated using Kaplan-Meier methods.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
1455552|NCT00811135|Secondary|Number of Participants With Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.|Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
1455553|NCT00811135|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first. Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methods.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||months||95% Confidence Interval|Median
1455554|NCT00811135|Secondary|Number of Participants With Disease Progression or Death|Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||participants|||Number
1455555|NCT00811135|Primary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0. BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence. Percentage of participants with a BOR of confirmed CR or PR (responders) was reported. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.|Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
1455556|NCT00811070|Secondary|Overall Survival (OS) Rate - Part 2|OS was based on Kaplan-Meier method. Survival was defined as the time period from the date of first dose of bosutinib to the date of death, censored at the participant's last contact date. Percent of participants with OS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455672|NCT00810303|Primary|Cmax of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30||||ng/ml||Standard Deviation|Mean
1455557|NCT00811070|Secondary|Progression-free Survival (PFS) Rate - Part 2|PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to treatment discontinuation due to disease progression as assessed by the investigator. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percent of participants with PFS were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455558|NCT00811070|Secondary|Time to Treatment Failure (TTF) Rate - Part 2|TTF was the interval from the date of first dose of bosutinib until the earlier date of progression or death (any cause), withdrawal from treatment owing to an AE, subject refusal, or loss to follow-up (censored at the last contact date), or further anti-tumor therapy before documented progression (whichever occurred first). TTF rate indicates the probability of no treatment failure. Percent of participants with no treatment failure were estimated.|Date of first dose of study drug up to Week 336 in primary second line participants; up to Week 192 in advanced second line and exploratory third line participants|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455559|NCT00811070|Secondary|Duration of Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The duration of OHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort|||weeks||95% Confidence Interval|Median
1455560|NCT00811070|Secondary|Time to Achieve Overall Hematologic Response (OHR) in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|The time to OHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population and who was in accelerated or blast phase in the third-line cohort|||weeks||95% Confidence Interval|Median
1455561|NCT00811070|Secondary|Percentage of Participants With Overall Hematologic Response (OHR) Up to Week 192 in Accelerated Phase/Blast Phase Third-line Cohort - Part 2|OHR included CHR, no evidence of leukemia (NEL), minor hematologic response (MiHR) or return to chronic phase (RCP), participants had to meet at least 1 of this criterion. Criteria for RCP: disappearance of features defining AP/BP, but still in CP and persistence of clonal evolution. Criteria for MiHR: <15% blasts in blood and bone marrow, <30% blasts+promyelocytes in blood and bone marrow, <20% basophils in blood, no extramedullary disease other than liver/spleen. Criteria for CHR and NEL: <20% basophils in blood, no extramedullary involvement including liver/spleen, no peripheral blasts or promyelocytes, myelocytes + metamyelocytes <5% in blood, <5% (NEL) and <=5% (CHR) marrow blasts, 0.5*10^9 <= Absolute neutrophil count (ANC) <1.0*10^9/L (NEL) and ANC>=1.0*10^9/L (CHR), 20*10^9 <=platelets<100 *10^9/L (NEL) and platelets>=100 but <450x10^9/L (CHR), white blood cells <=institutional upper limit of the normal range.|Baseline up to Week 192|Subset of the third-line cohort who was in accelerated or blast phase|||percentage of participants|||Number
1455562|NCT00811070|Secondary|Duration of Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of first attained response - date of first attained response)/7.|Baseline up to Week 192|Subset of participants who had the response among all treated population|||weeks||95% Confidence Interval|Median
1455563|NCT00811070|Secondary|Time to Achieve Complete Hematologic Response (CHR) in Advanced Phase Second-line Cohort - Part 2|The time to CHR was measured from the date of first dosing to the first date of response. Time to response in weeks = (event date - first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last assessment date of a participant.|Baseline up to Week 192|Subset of participants who had the response among all treated population.|||weeks||95% Confidence Interval|Median
1455564|NCT00811070|Secondary|Percentage of Participants With Complete Hematologic Response (CHR) up to Week 192 in Advance Phase Second-line Cohort - Part 2|CHR response was considered to be achieved if participants met all of the following criteria: White Blood Cells =< institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes <5% in blood, absolute neutrophil count >=1.0*10^9 per liter (/L), platelets >=100 but <450*10^9/L, <20% basophils in blood and no extramedulary involvement (including hepato- or splenomegaly), =<5% BM blasts.|Baseline up to Week 192|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455565|NCT00811070|Secondary|Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|Duration of MCyR was defined as the interval from the date of the earliest demonstration of a response, until the earliest date of loss of that response. Duration of response in weeks = (date of confirmed loss of first attained response minus date of first attained response)/7 days.|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population|||weeks||95% Confidence Interval|Median
1455566|NCT00811070|Secondary|Time to Major Cytogenetic Response (MCyR) in Chronic Phase Second-line and Third-line Cohort - Part 2|"Time to MCyR was the interval from the date of first dose of study medication until the first date of achieving a given response.~Time to response in weeks = (event date minus first dose date plus 1)/7, where the event date is the non-missing date of the first attained response or last cytogenetic assessment date of a participants."|204 weeks in the second-line participants and 48 weeks in the third-line participants|Subset of participants who had the response among all treated population|||weeks||95% Confidence Interval|Median
1455737|NCT00810069|Secondary|Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response||Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||participants|||Number
1455567|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Third-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455568|NCT00811070|Secondary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 - Part 1|Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455569|NCT00811070|Secondary|Percentage of Participants With Maintained Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line and Third-line Cohort - Part 2|"Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.~The responder for maintained MCyR included 'participants without baseline response who had a response at a specified time' and 'participants with baseline response who had a post-baseline response either maintained or improved at a specified time'."|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455570|NCT00811070|Primary|Percentage of Participants With Major Cytogenetic Response (MCyR) at Week 24 in Chronic Phase Second-line Cohort - Part 2|Cytogenetic response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) cells. Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was 0 percent (%) Ph+ cells and PCyR was achieved when 1 to 35% Ph+ cells.|Week 24|All treated population was defined as all participants who received at least 1 dose of bosutinib.|||percentage of participants||95% Confidence Interval|Number
1455571|NCT00811070|Secondary|Accumulation Ratio (R) - Part 1|R=accumulation ratio (AUCss on Day 15/AUC[0-24] on Day 1)|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Mean
1455572|NCT00811070|Secondary|Apparent Volume of Distribution (Vz/F) - Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.|||liter||Standard Deviation|Mean
1455573|NCT00811070|Secondary|Apparent Oral Clearance (CL/F) - Part 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F on Day 15 was assessed as the steady state CL/F.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||L/hr||Standard Deviation|Mean
1455574|NCT00811070|Secondary|Area Under the Concentration-Time Curve (AUC) - Part 1|Area under the plasma concentration time-curve from zero to infinity. AUC on Day 15 was assessed as the steady state AUC.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||nanogram*hour per milliliter (ng•hr/mL)||Standard Deviation|Mean
1455575|NCT00811070|Secondary|Plasma Decay Half-Life (t1/2) - Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1|The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.|||hour||Standard Deviation|Mean
1455576|NCT00811070|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||hour||Full Range|Median
1455577|NCT00811070|Secondary|Maximum Observed Plasma Concentration (Cmax) - Part 1||Before and 1, 2, 3, 4, 6, 8, 24 and 48 hours after administration on Day 1, and before and 1, 2, 3, 4, 6, 8, and 24 hours after administration on Day 15|"The pharmacokinetic parameter population was defined as all participants who received at least 1 dose of bosutinib and had at least 1 of the pharmacokinetic parameters of interest.~n= number of participants analyzed."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1455578|NCT00811070|Primary|Maximum Tolerated Dose (MTD) - Part 1|MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.|||mg|||Number
1455579|NCT00811070|Primary|Number of Participants With Dose-Limiting Toxicity (DLT) - Part 1|DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity.|Baseline up to Day 28 (Part 1 )|Participants enrolled in Part 1 of the study were analyzed for DLT. Two participants (1 each in the 400 mg and 500 mg) who discontinued the treatment by Day 28 due to non-safety reasons were excluded from the analysis.|||Participants|||Number
1455580|NCT00811057|Secondary|The Secondary Outcome Measure of This Research is the Days Gained After Treatment to Delivery|Days gained after treatment to delivery|after delivery of the infant||||days||Standard Deviation|Mean
1455581|NCT00811057|Primary|The Primary Outcome Measure of This Research is to Compare the Efficacy of the Three Clinically Used Tocolytic Agents in a Prospective Study That Will Allow Direct Comparison of Outcomes in Women With Confirmed Preterm Labor.|Gestational age at delivery in weeks.|3-5 days after delivery||||weeks||Standard Deviation|Mean
1455582|NCT00811018|Primary|Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)|PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
1455583|NCT00811018|Primary|Percentage of Participants With Abnormal Prothrombin Time (PT)|PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
1455584|NCT00811018|Primary|Percentage of Participants With Vital Sign Results of Potential Clinical Importance|Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.|Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
1455585|NCT00811018|Primary|Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance|Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.|Weeks 28,60,72,84,96,104, Transition Visit up to 82 months|Data not summarized, study terminated early|||percentage of participants|||Number
1455586|NCT00811018|Primary|Percentage of Participants With Elevated International Normalize Ratio (INR)|Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population|||percentage of participants|||Number
1455587|NCT00811018|Primary|Percentage of Participants With Anticoagulant Use|Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.|Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months|Safety Population|||percentage of participants|||Number
1455588|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)|Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab|||percentage of participants|||Number
1455589|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Chemistry)|Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab|||percentage of participants|||Number
1455590|NCT00811018|Primary|Percentage of Participants With Laboratory Test Abnormalities (Hematology)|Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population; N=number of participants with normal observation at baseline; n=number of participants with normal baseline and an abnormality meeting specific criteria for the specific lab|||percentage of participants|||Number
1455591|NCT00811018|Primary|Percentage of Participants With Total Bilirubin > 1.5 x ULN|Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population|||percentage of participants|||Number
1455592|NCT00811018|Primary|The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population|||percentage of participants|||Number
1455593|NCT00811018|Primary|The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)|ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.|Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months|Safety Population|||percentage of participants|||Number
1455594|NCT00811018|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.|Day 1 up to 82 months|Safety Population: all enrolled participants who took at least one dose of sitaxsentan 100 mg during the study|||participants|||Number
1455597|NCT00810888|Secondary|Percent Change in Total Hemorrhage Volume (Intracerebral Hemorrhage (ICH) Plus Intraventricular Hemorrhage (IVH)).|Percent change in total volume (intracerebral hemorrhage (ICH) plus intraventricular hemorrhage (IVH)) from baseline CT to 24 hour CT. Percent change is expressed as difference between 24 hour total volume and baseline total volume divided by baseline total volume, expressed as a percentage. In order to examine the effect of rFIVIIa, the randomized groups, Group 1 and Group 2 only were statistically compared.|24 hours (+/- 3 hours) from baseline CT scan|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Percent change from baseline to 24 hours||Inter-Quartile Range|Median
1455598|NCT00810888|Secondary|Number of Participants With Agreement Between the Clinical Site Radiologists and the Study Radiologist With Respect to Identification of a Positive Spot Sign or the Absence of Positive Spot Sign on CTA|The CTA was originally interpreted by the site radiologist so that subjects could be identified as having a positive spot sign for eligibility for randomization. The positive spot sign is indicative that there is potential for further hemorrhagic growth and these subjects were thus eligible to be randomized to receive investigational drug or placebo. The CTA scans were subsequently assessed by the study radiologist and compared for agreement.|Baseline head CT scan within 5 hours, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Overall agreement was assessed but reported by group below."|||Participants|||Count of Participants
1455599|NCT00810888|Secondary|Number of Spot Positive Subjects With 90-day Outcome of Modified Rankin Scale Score >= 5|The modified Rankin Scale (0 is best, 5 is worst - non dead, 6 is dead) was used to define a bad outcome; categorized as a score >=5 versus <5. As the aim of the study was to examine the effect of rFIV!!a only the randomized groups, 1 and 2, defined as spot positive by CTA were compared.|90 days (+/- 7 days) from time of study enrollment|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
1455600|NCT00810888|Secondary|Number of Participants With Other Potentially Study Drug Related Thromboembolic Complications Such as Deep Venous Thrombosis (DVT) and Elevations in Troponin Not Associated With ECG Changes|Evidence of a deep venous thrombosis or an elevation of troponin within 4 days of completion of study drug administration that are not associated with ECG changes that could be related to the study drug|through day 4 after completion of study drug|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
1455601|NCT00810888|Primary|The Specificity of the Spot Sign for Predicting Hematoma Growth|The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Specificity was estimated. Specificity or true negative rate is defined as, the number of non-spot positive (spot negative) strokes according to the “gold standard” / the total number of strokes identified as not spot positive.|Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group 2 and Group 3."|||Participants|||Count of Participants
1455602|NCT00810888|Primary|The Sensitivity of the Spot Sign for Predicting Hematoma Growth|The outcome measure is hematoma growth. Groups 2 and 3 only will be compared as Group 1 had administration of study drug which was hypothesized to reduce hematoma growth. Sensitivity was estimated. Sensitivity or true positive rate is defined as, the number of strokes correctly identified as spot positive according to the “gold standard” / the total number of strokes identified as spot positive|Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours.|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group 2 and Group 3."|||Participants|||Count of Participants
1455603|NCT00810888|Primary|Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours.|Comparison of only the subjects with a positive spot sign with respect to a categorical measure of hematoma growth from baseline to 24 hours. the outcome of interest is the percent of subjects with hematoma growth > 33% or > 6 cc increase in volume, from baseline to 24 hours.|From baseline to 24 hours|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
1455604|NCT00810888|Primary|Number of Study Subjects With Life-threatening Thromboembolic Complications|Thromboembolic complications are defined as development of (1) acute myocardial ischemia; or (2) acute cerebral ischemia; or (3) acute pulmonary embolism|through day 4 after completion of study drug administration|"The analysis population consists of 19 subjects diagnosed as Spot Positive on CT who were eligible for randomization within the clinical trial portion of the protocol, as well as 73 subjects diagnosed as Spot Negative on CT who were followed prospectively with no study intervention. Statistical comparison involves only Group1 and Group 2."|||Participants|||Count of Participants
1455605|NCT00810810|Secondary|Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines|Blood samples were collected prior to surgery and at two times after surgery. White blood cells were isolated and frozen. The thawed cells were tested for the numbers and phenotype of regulatory cells and for the production of regulatory cytokines. Results obtained from samples collected after surgery were compared to the results obtained from the sample collected prior to surgery.|0 to 5 weeks after surgery|The study used stringent criteria for acceptance of these cellular assays. Invalid tests were not included in the analysis, therefor the numbers reported in the Outcome Measures table do not add up to the number analyzed for each test.|||Participants|||Count of Participants
1455606|NCT00810810|Primary|Number of Participants With Changes in the Production of Antibody to HLA Antigens|Blood samples were collected prior to surgery and at two times after surgery. Serum was tested for the presence of IgG antibody to HLA. the results of the samples collected after surgery were compared to those in the sample collected prior to surgery.|0 to 5 weeks after surgery|Antibody tests were invalid for some participants in Arm 1. Their sera contained interfering substances.|||Participants|||Count of Participants
1455607|NCT00810771|Secondary|If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.|"Outcome measure measuring percentage of participants discussing CRCS with provider using single question (yes/no): did you discuss Colorectal Cancer Screening with your provider?"|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
1455608|NCT00810771|Secondary|Self Efficacy.|Outcome measure measuring self-efficacy using 5-item measure, dichotomized into low vs. high self-efficacy (confidence) in getting screened.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
1455609|NCT00810771|Secondary|Intent to Get Colorectal Cancer Screening.|Outcome measure measuring intent to get CRC screening using 5-item stage of readiness scale. Intent is measured by looking at the highest 2 items (I think I will get screened and I am committed to getting screened).|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
1455610|NCT00810771|Secondary|Decisional Satisfaction|"Outcome measures measuring decisional satisfaction using 7-item scale categorized into low, moderate, high.~Decisional satisfaction is a measure that was first developed by Margaret Holmes Rover and colleagues (Med Decis Making. 1996 Jan-Mar;16(1):58-64) to assess the perspective of a patient involved in a medical decision with the decision making process. The measure includes questions related to overall satisfaction, and satisfaction with the amount of information received, involvement in, degree of consistency with values, and time to make the decision. The measure includes 5 questions each on a 5 point scale where higher scores = higher satisfaction. When scaled into one overall measure of decision satisfaction, lower scores = lower satisfaction and higher scores = higher satisfaction."|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||Percentage of participants|||Number
1455611|NCT00810771|Secondary|Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.|Outcome measure measuring knowledge of CRCS using 8-item knowledge measure (all true/false questions) developed for study, scaled and categorized into low/moderate/high knowledge, where low = low knowledge and high = high knowledge.|3-5 days after Decider Guider intervention.|Data was not collected for Usual Care arm.|||percentage of participants|||Number
1455612|NCT00810771|Secondary|Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider|Outcome measure using 6 items measuring degree of participation in IDM. Scaled and recategorized into Low, Moderate and High level of IDM. The range is from 1 (low level of IDM) to 6 (high level of IDM).|3-5 days after Decider Guider intervention|Data was not collected for Usual Care arm.|||Degree of participation||Full Range|Mean
1455613|NCT00810771|Primary|Colorectal Cancer (CRC) Screening Rate.|The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.|Within 6 months of Decider Guider intervention.||||percentage of participants|||Number
1455614|NCT00810719|Secondary|Overall Survival|Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up.|Up to 36 months||||months||95% Confidence Interval|Median
1455615|NCT00810719|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 36 months|Two patients withdrew consent in the first cycle and were not evaluable for response.|||percentage of participants|||Number
1455616|NCT00810719|Primary|Progression Free Survival|Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 36 months||||months||95% Confidence Interval|Median
1455617|NCT00810693|Secondary|Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12|The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual’s quality of life. The LPH total score can range from 0 (best) to 105 (worst).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.|||Scores on a scale||Standard Deviation|Mean
1455673|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20||||ng/ml||Standard Deviation|Mean
1455618|NCT00810693|Secondary|EQ-5D Utility Score - Change From Baseline to Week 12|EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.|||Scores on a scale||Standard Deviation|Mean
1455619|NCT00810693|Secondary|Borg CR 10 Scale - Change From Baseline to Week 12|"The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant's exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 (Nothing at all) to 10 (“Extremely strong – Maximal”)."|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Scores on a scale||Standard Deviation|Mean
1455620|NCT00810693|Secondary|Percentage of Participants With Clinical Worsening|The combined endpoint “time to clinical worsening”, made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .|At week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Percentage of participants|||Number
1455621|NCT00810693|Secondary|World Health Organization (WHO) Functional Class - Change From Baseline to Week 12|The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.|||Percentage of participants|||Number
1455622|NCT00810693|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12|N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.|||pg/mL||Standard Deviation|Mean
1455623|NCT00810693|Secondary|Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12|The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.|||dyn*s*cm^-5||Standard Deviation|Mean
1455624|NCT00810693|Primary|6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12|6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.|Baseline and week 12|Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.|||Meters||Standard Deviation|Mean
1455625|NCT00810641|Primary|Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial|The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.|one hour|Of the 157 patients enrolled in the study, three were lost for follow-up (dropout rate, 1.9%) and 154 were finally included for analyses.|||participants||95% Confidence Interval|Number
1455626|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, Measuring Time to Consent From the Last Concussion in Subjects With Multiple Concussions.|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) with consent within one year from the last concussion in subjects who had multiple concussions.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up||||participants|||Number
1455634|NCT00810615|Primary|Computer Cognitive Test Scores – BrainCheckers Code Sub Recall|BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 135. The scores in this section represent results of the code sub recall subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1456525|NCT00804648|Primary|Stinging on Instillation|Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
1455627|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Multiple Non-concussive Blast and/or Impact Exposures.|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated for the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. Many subjects had multiple blast and/or impact events without a concussion (asymptomatic), but had a flight or flight (danger response) experience. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced multiple non-concussive blast and/or impact events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion who had multiple blast and/or impact event that did not result in a concussion (asymptomatic), but had a flight or flight (danger response) experience.|||participants|||Number
1455628|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Four or More Concussive Events|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced four or more concussive events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
1455629|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Three Concussive Events|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced three concussive events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
1455630|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Two Concussive Events|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in individuals who experienced two concussive events.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
1455631|NCT00810615|Post-Hoc|PCL-M Relative Risk of Improvement of 2.4 ATA Exposures vs. Sham, All Participants With Only One Concussive Event|The purpose of a pilot study is to identify potential subgroups who may respond to treatment. The various composite scores were ranked and separated by subject and within groups for those who improved and those who did not. This allowed the application relative risk analysis using MedCalc (http://www.medcalc.org) to identify potential subgroups. Relative Risk of Improvement (RROI) was calculated against the concussion history items. Main categories were the number of concussive events, whether the subject had multiple non-concussive events or not, if there were two concussive events within a 48 hour period, the time expired from the last concussion to consent, the etiology of the event, and loss of consciousness. A concussive event was defined as one immediately followed with symptoms. This outcome measure analyzed PCL-M score decreases of 10 or more (significantly improved) in the individuals who experienced only one concussive event.|Baseline values compared to 30 post hyperbaric exposure or 6 week follow-up|Participants with significant improvement (PCL-M composite scores demonstrating a decrease by 10 or greater) or participants not meeting this criterion.|||participants|||Number
1455632|NCT00810615|Secondary|Stem Cells: CD_34|A non-parametric regression 14 using the Theil estimator was fit to the observed data in order to demonstrate general trends for relations between measures of cognitive functioning and increased stem cells.|six weeks post hyperbaric exposure series|||||||
1455633|NCT00810615|Secondary|Functional MRI||six weeks post hyperbaric exposure series|||||||
1455674|NCT00810303|Primary|Cmax of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5||||ng/ml||Standard Deviation|Mean
1455635|NCT00810615|Primary|Computer Cognitive Test Scores – BrainCheckers Matching To Sample|BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 50. The scores in this section represent results of the matching to sample subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455636|NCT00810615|Primary|Computer Cognitive Test Scores – BrainCheckers Go-NoGo Reaction Time|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 41 to 174. The scores in this section represent results of the Go-NoGo reaction time subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455637|NCT00810615|Primary|Computer Cognitive Test Scores – BrainCheckers Procedural Reaction Time|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 25 to 118. The scores in this section represent results of the procedural reaction time.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455638|NCT00810615|Primary|Computer Cognitive Test Scores – BrainCheckers Code Substitution|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 9 to 66. The scores in this section represent results of the code substitution subtest.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455639|NCT00810615|Primary|Computer Cognitive Test Scores – BrainCheckers Simple Reaction Time|Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The simple reaction time range is 30 to 255.|Baseline and six weeks post hyperbaric exposure series|One subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455640|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Reaction Time|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The reaction time score demonstrates improvement as the score decreases. The score range was 0.42 to 1.84.|Baseline and six weeks post hyperbaric exposure series|one subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455641|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Processing Speed|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The Processing Speed score demonstrates improvement as the score increases. The score range was 9.7 to 52.4.|Baseline and six weeks post hyperbaric exposure series|one subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455642|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Visual Memory|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The visual memory score demonstrates improvement as the score increases. The score range was 31.2 to 92.7.|Baseline and six weeks post hyperbaric exposure series||||units on a scale||Standard Deviation|Mean
1455643|NCT00810615|Primary|Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores|The PCL-M is a self reported test in which a list of 17 problems and complaints are offered to the individual to score on a 1 to 5 scale with 1 designating “not at all”, 2= “a little bit”, 3= “moderately”, 4= “quite a bit” and 5 designating “extremely”. A sample complaint would be “repeated, disturbing dreams of a stressful military experience”. Hence there is a possible total score range from 17 to 85. For military members, a score of 50 or above is indicative of PTSD. A change from baseline of 5-9 represents a reliable change and change of 10 or greater is a significant change.|baseline compared to the change at post hyperbaric exposures (30) series and the six weeks post hyperbaric exposure series|Per protocol. The study was a pilot.|||units on a scale||Standard Deviation|Mean
1455644|NCT00810615|Primary|Computer Cognitive Test Scores - ImPACT Verbal Memory|The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The verbal memory score demonstrates improvement as the score increases. The score range was 36.8 to 98.6.|Baseline and six weeks post hyperbaric exposure series|one subject withdrawal from each group due to personal reasons|||units on a scale||Standard Deviation|Mean
1455645|NCT00810602|Secondary|Percent Survival at 2-years|To determine 2-year overall survival rate|two years|evaluable subjects|||percentage of subjects|||Number
1455646|NCT00810602|Secondary|Percent Cumulative Incidence of Relapse at 2 Years.|Determine the cumulative incidence of relapse at 2 years.|two years|evaluable subjects|||percentage of participants|||Number
1455647|NCT00810602|Secondary|Number of Serious Adverse Events|The safety and feasibility will be partially measured by the number of serious adverse events (SAE) recorded by participants receiving at least one dose of Vorinostat.|100 days|The number of patients who received at least one dose of vorinostat.|||Number of Serious Adverse Events|||Number
1455648|NCT00810602|Primary|100-day Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GVHD)|Assess if the addition of Vorinostat to standard GVHD prophylaxis regimen can reduce the rate of grades 2-4 acute GVHD when compared to 48% in a cohort of identically treated RIC HSCT patients without vorinostat. A reduction of incidence to less than 25% will be considered successful.|100 days|evaluable|||percentage of participants|||Number
1455649|NCT00810576|Primary|Number of Patients With Response|Computed tomography scans and/or Positron emission tomography (PET) scans obtained every two cycles to evaluate response using International Workshop Criteria of Complete Response, Partial Response, Progressive Disease, or Stable Disease.|Every two 21-day cycles|No analysis done due to early termination resulting from low accrual.|||participants|||Number
1455650|NCT00810511|Primary|Comfort at End of Day|Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.|After 4 weeks of wear|One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation.|||Scale of 1-10||Standard Deviation|Mean
1455651|NCT00810394|Secondary|Time to Disease Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years||||months||95% Confidence Interval|Median
1455652|NCT00810394|Secondary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR).|At least 3 months|Of the 34 patients who were evaluable for treatment response by RECIST, no responses were observed.|||Participants|||Count of Participants
1455653|NCT00810394|Primary|Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity|Overall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.|At least 3 months||||Participants|||Count of Participants
1455654|NCT00810368|Primary|Incremental Change in SF36 General Health Between Baseline and Week 12|Incremental change in SF36 General Health score from baseline to week 12. The SF36 General Health score ranges from 0 (very bad General Health) to 100 (very good General Health). The incremental change was the SF36 General Health score at week 12 minus the SF36 General Health score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for SF36 General Health score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the SF36 General Health score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
1455655|NCT00810368|Primary|Incremental Change in Generalized Anxiety Scale (GAD) Scores From Baseline to Week 12|Each item on the Generalized Anxiety Scale (GAD) scores was scored as none (0), trivial (1), mild (2), moderate (3), or severe (4) and the sum of the 7 items calculated (range 0 to 28). The incremental change between Week 0 and Week 12 was determined for each treatment.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
1455656|NCT00810368|Primary|SF36 Bodily Pain|Incremental change in Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score from baseline to week 12. The Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score ranges from 0 (very bad bodily pain) to 100 (no bodily pain). The incremental change was the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at week 12 minus the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline. The range of scores for incremental change was from -100 to +100. Scores of 0 for Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline and +100 at week 12 indicate an incremental change of 100 - 0 = +100. A score of 100 at baseline for the Medical Outcome Survey Short Form 36 questionnaire (SF36) Bodily Pain score at baseline of +100 at week 12 gives an incremental change of 0 - 100 = -100.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
1455657|NCT00810368|Primary|Incremental Change in Fatigue Score From Baseline to Week 12|Instantaneous Fatigue was scored as none (0) to severe (10) at week 0 and week 12. The difference between the Week 12 minus the Week 0 values was the incremental change. If the incremental change was greater than 0, then the Instantaneous Fatigue was worse at week 12 than week 0. If the incremental change was less than 0, then the Instantaneous Fatigue was improved at week 12 compared to week 0. The total potential range for incremental change was from -10 to +10.|Week 0 and Week 12|Number of participants with evaluable data who completed the study|||units on a scale||95% Confidence Interval|Mean
1455658|NCT00810368|Secondary|Digit Symbol Substitution (WAIS)|Digit Symbol Substitution (WAIS) test (Joy et al., 2000): Subjects were given a table of numerals with matching symbols, and a form with random numerals with open spaces. The objective was to write in as many symbols that corresponded to the random numerals within a 90 second period. Each subject was their own control. The outcome measure was the incremental change in this score between Week 0 and Week 12 (units on a scale). Higher scores indicate better performance.|Difference between Week 0 and Week 12 (end of study)|2 carnosine subjects had incomplete data.|||units on a scale||95% Confidence Interval|Mean
1455659|NCT00810368|Primary|Subjects With Improved Diarrhea Symptoms|Patients were given questionnaires assessing common symptom complaints of diarrhea.|Weeks 0 and 12|Participants with evaluable data at the end of the study.|||participants|||Number
1455660|NCT00810368|Primary|Effect of Carnosine Supplementation on Chronic Fatigue Syndrome Severity Scores|"CFS Severity Score (Δ ≥ 5 / 36) (Baraniuk et al., 1998; Baraniuk et al., 2000a; Baraniuk, Naranch, Maibach, & Clauw, 2000b). Subjects scored the severity of the 9 CFS criteria (Fatigue, memory/concentration, sore throat, sore lymph nodes, sore muscles, sore joints, headache, sleep disturbances, exertional exhaustion from Fukuda et al. 1994) on a scale of none (score=0), trivial (1), mild (2), moderate (3) and severe (4). The sum was 36.~Individuals taking carnosine were predicted to show a decrease of ≥ 5 at week 12 compared to week 0, compared to no change for placebo subjects. 2-tailed paired t-tests were used to determine significant incremental changes for individuals in the carnosine group compared to the placebo group."|Weeks 0 and 12|Significant numbers of subjects dropped out of both arms of the study. The primary reason given was perceived lack of efficacy.|||units on a scale||95% Confidence Interval|Mean
1455661|NCT00810355|Primary|Symptoms|Symptoms (positive, negative, cognitive, hostility, and depression subscales) are rated on Positive and Negative Syndrome Scale (PANSS). These are averages of each subscale: positive (range 6-42), negative (range 8-56), cognitive (range 7-49), hostility (range 4-28), depression (range 4-28). Higher scores indicate more extreme /worse symptoms.|6 months||||scores on a scale||Standard Deviation|Mean
1455662|NCT00810355|Primary|Work Quantity|Average number of hours worked per week. Higher numbers represent more hours worked, ranging from 0-40.|6 months||||hours worked per week||Standard Deviation|Mean
1455663|NCT00810355|Primary|Work Quality|Average work performance scored on the Work Behavior Inventory (WBI) by total average of the 5 subscales. Scores range from 1-5. Higher scores represent better work performance.|6 months||||scores on a scale||Standard Deviation|Mean
1455664|NCT00810342|Secondary|Accelerometer Collected Moderate to Vigorous Physical Activity|Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months|12-Months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii|||minutes per week moderate-to-vigorous PA||95% Confidence Interval|Mean
1455665|NCT00810342|Primary|Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months|Self reported minutes of moderate or vigorous physical activity per week after 12-months|12 months|Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii|||minutes per week moderate-to-vigorous PA||Inter-Quartile Range|Mean
1455666|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30||||ng/ml||Standard Deviation|Mean
1455667|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16||||ng/ml||Standard Deviation|Mean
1455668|NCT00810303|Secondary|Cmax of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15||||ng/ml||Standard Deviation|Mean
1455669|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 30||||ng*h/ml||Standard Deviation|Mean
1455670|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 16||||ng*h/ml||Standard Deviation|Mean
1455671|NCT00810303|Secondary|AUC0-24h of Ezetimibe Glucuronide (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of ezetimibe glucuronide in the blood samplings.|study day 15||||ng*h/ml||Standard Deviation|Mean
1455675|NCT00810303|Primary|AUC0-24h of Efavirenz (Steady State Pharmacokinetic After Chronic Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study day 30||||ng*h/ml||Standard Deviation|Mean
1455676|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz and Concomitant Chronic Treatment of 10 mg Ezetimibe) on Study Days 16-20|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 16-20||||ng*h/ml||Standard Deviation|Mean
1455677|NCT00810303|Primary|AUC of Efavirenz (Single Dose Pharmacokinetic After Treatment With 400 mg Efavirenz) on Study Days 1-5|The area under the concentrations-time curve (AUC) was calculated with the measured data points from the time of administration until the last quantificable concentration by the trapezoidal formula and the extrapolation to infinity. The concentration-time curve is the result of time points of blood sampling and its measured concentration of efavirenz in the blood samplings.|study days 1-5||||ng*h/ml||Standard Deviation|Mean
1455678|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30||||ng/ml||Standard Deviation|Mean
1455679|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16||||ng/ml||Standard Deviation|Mean
1455680|NCT00810303|Primary|Cmax of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15||||ng/ml||Standard Deviation|Mean
1455681|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Chronic Treatment With 400 mg Efavirenz) on Study Day 30|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 30||||ng*h/ml||Standard Deviation|Mean
1455682|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe and Concomitant Single Dose Administration of 400 mg Efavirenz) on Study Day 16|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 16||||ng*h/ml||Standard Deviation|Mean
1455683|NCT00810303|Primary|AUC0-24h of Free Ezetimibe (Steady-state Pharmacokinetic After Chronic Treatment With 10 mg Ezetimibe) on Study Day 15|The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration of free ezetimibe in the blood samplings.|study day 15||||ng*h/ml||Standard Deviation|Mean
1455684|NCT00810277|Secondary|Neutrophil Count||Baseline, Weeks 4, 8, and 12|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||E^9 per liter||Standard Deviation|Mean
1455685|NCT00810277|Secondary|Percentage of Participants With Lipid Level Elevations|Low density lipoprotein (LDL) level was categorized as 'Optimal (less than [<] 100 milligram per deciliter [mg/dL])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as ‘Acceptable (40-59 mg/dL)’, ‘High (>=60 mg/dL)’. Total cholesterol (TC) level was categorized as ‘Desirable (<200 mg/dL)’, ‘Borderline High (200-239 mg/dL)’, ‘High (>=240 mg/dL)’.|Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
1455686|NCT00810277|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal|Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum.|Up to Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
1455687|NCT00810277|Secondary|Percentage of Participants Who Discontinued the Study||Up to Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
1455688|NCT00810277|Secondary|Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||millimeter per hour (mm/h)||Standard Deviation|Mean
1455689|NCT00810277|Secondary|C-Reactive Protein (CRP) Level||Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||milligram per liter (mg/L)||Standard Deviation|Mean
1456711|NCT00802997|Primary|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
1455690|NCT00810277|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response|ACR20, ACR50, and ACR70 response: greater than or equal to (>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do).|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||percentage of participants|||Number
1455691|NCT00810277|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||percentage of participants|||Number
1455692|NCT00810277|Secondary|Disease Activity Score (DAS28)|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category.|||units on a scale||Standard Deviation|Mean
1455693|NCT00810277|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.|Baseline up to Week 24|Analysis population included all participants who entered the study.|||percentage of participants|||Number
1455694|NCT00810199|Secondary|Time to Restart of Treatment After Discontinuation/Remission|The time in days from treatment discontinuation or remission to the restart of treatment.|104 Weeks|Participants from the intent-to-treat population, all participants who received study drug, with data available for analysis. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response had not been observed.|||Days||95% Confidence Interval|Median
1455695|NCT00810199|Secondary|Time to Flare After Tocilizumab Remission|The time in days to a flare (recurrence of disease symptoms) after the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.|||Days||Full Range|Median
1455696|NCT00810199|Secondary|Time to Drug-Free Remission|The time in days from initial study drug treatment to drug free remission that occurred when the participant was able to discontinue tocilizumab, methotrexate/placebo and open label disease-modifying antirheumatic drugs (DMARDS).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.|||Days||Full Range|Median
1455697|NCT00810199|Secondary|Time to Tocilizumab Remission|The time in days from initial study drug treatment to tocilizumab remission that occurred when the patient discontinued treatment with tocilizumab.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for this outcome measure. Participants were censored at the last observed value.|||Days||Full Range|Median
1455698|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 52 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].Area under the curve for ACR response to Week 52 averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (<=5.5 and >5.5) as fixed factors.|Baseline to Week 52|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.|||Score on a scale*day||Standard Error|Least Squares Mean
1455699|NCT00810199|Secondary|Area Under the Curve (AUC) From Baseline to Week 24 for ACR Response|ACR response was defined as an improvement (reduction) compared with baseline for both total joint count-68 joints and swollen joint count-66 joints, and for three of five variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) where 0=no pain to 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where: 0=no disease activity to 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]. Area under the curve for ACR response to Week 24 was averaged over study days. Analysis of covariance model includes treatment group, region and baseline DAS28 (≤ 5.5 and > 5.5) as fixed factors.|Baseline to Week 24|Participants from the intent-to-treat population, all participants who received study drug, with ACR response available for analysis at the time-point. Participants with early withdrawals are not included.|||Score on a scale*day||Standard Error|Least Squares Mean
1455700|NCT00810199|Secondary|Change From Baseline in Academic Medical Center (AMC) Linear Disability Scale (ALDS)|The Academic Medical Center (AMC) Linear Disability Score (ALDS) evaluates the participant’s ability to perform activities of daily life consisting of 77 questions answered yes or no . The question difficulty and the patient’s ability are arranged on a single hierarchical linear scale. ALDS scores range from 10 to 90 with a higher score representing higher functional status. A positive change from Baseline indicated improvement.|Baseline, Weeks 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis.|||Score on a scale||Standard Deviation|Mean
1455701|NCT00810199|Secondary|Change From Baseline in Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL)|The RAQoL is a disease specific patient-reported outcome measure that determines the effect rheumatoid arthritis has on a patient’s quality of life consisting of 30 questions that are answered either yes=1 or no=0 for a total possible score ranging from 0 (best) to 30 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52, 104|Participants from the intent-to-treat Population, all participants who received study drug, with data available for analysis at the given time-point. The RAQoL score was administered in a subset of sites for which the questionnaire was available in the local language.|||Score on a scale||Standard Deviation|Mean
1455702|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Safety Reasons|Safety reasons were defined as adverse events, intercurrent illness or death. An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455703|NCT00810199|Secondary|Percentage of Participants Who Withdrew Due to Lack of Sufficient Therapeutic Response|Lack of Sufficient Therapeutic Response was defined as the patient not responding to the drug as expected.|Up to 3 years|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455704|NCT00810199|Secondary|Percentage of Participants Discontinuing Tocilizumab Due to Remission|The percentage of participants who stopped treatment with tocilizumab due to remission.|Weeks 52, 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with non-missing DAS28 assessment.|||Percentage of participants|||Number
1455705|NCT00810199|Secondary|Change From Baseline in Erosion Score|A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. The maximum erosion score in the hands was 98 and in the feet 42 for a total possible score of 0 to 140. A lower number change from Baseline indicated a better score.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.|||Score on a scale||Standard Error|Least Squares Mean
1455706|NCT00810199|Secondary|Change From Baseline in Joint Space Narrowing Score|A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum scores for joint space narrowing (JSN) in the hands was 104 and in the feet 48 for a total possible score of 0 to 152. A lower change from Baseline indicated a better score. Analysis of covariance model included baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.|||Score on a scale||Standard Error|Least Squares Mean
1455707|NCT00810199|Secondary|Change From Baseline in Total Genant Modified Sharp Scores (GSS)|Radiographs were taken of each hand and foot at Baseline, Weeks 24, 52 and104 and were evaluated using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 98 and in the feet 42. The maximum scores for joint space narrowing (JSN) in the hands was104 and in the feet 48. The total score was the sum of scores for erosions and JSN. The maximum total modified GSS was 292. A lower number change from Baseline was better. Analysis of covariance model, with Baseline DAS28 as a covariate and treatment and site as fixed factors.|Baseline, Weeks 24, 52, 104|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at Baseline and the given time point.|||Score on a scale||Standard Error|Least Squares Mean
1455734|NCT00810095|Primary|Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter.|"TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures:~TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|All participants treated with the Test System|||percentage of participants|||Number
1455708|NCT00810199|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability Index|The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A patient must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis at the given time-point.|||Score on a scale||Standard Deviation|Mean
1455709|NCT00810199|Secondary|Change From Baseline in C-Reactive Protein (CRP)|Blood was collected for C-Reactive Protein (CRP) (a test for analysis of inflammatory and infectious disorders) and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with data available for analysis at the given time-point.|||mg/dL||Standard Deviation|Mean
1455710|NCT00810199|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Blood was collected for Erythrocyte Sedimentation Rate (ESR) (a test that assesses tissue inflammation) and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm/hr||Standard Deviation|Mean
1455711|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Pain (VAS)|"The patient assessed their pain using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm||Standard Deviation|Mean
1455712|NCT00810199|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The physician global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm||Standard Deviation|Mean
1455713|NCT00810199|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (VAS)|"The patients global assessment of disease activity was assessed on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||mm||Standard Deviation|Mean
1455714|NCT00810199|Secondary|Change From Baseline in Tender Joint Count|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Joint count||Standard Deviation|Mean
1455715|NCT00810199|Secondary|Change From Baseline in Swollen Joint Count|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Joint count||Standard Deviation|Mean
1455716|NCT00810199|Secondary|Percentage of Participants With Good or Moderate European League (EULAR) DAS28 Responses|"The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 or a change from Baseline < -1.2.~EULAR Moderate response: DAS28 > 3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455717|NCT00810199|Secondary|Change From Baseline in DAS28 Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A higher value indicated higher disease activity. A negative change from Baseline indicated improvement.|Baseline, Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Score on a scale||Standard Deviation|Mean
1455718|NCT00810199|Secondary|Percentage of Participants With DAS28 Low Disease Activity (LDAS)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2.|Weeks 24, 52|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455719|NCT00810199|Secondary|Percentage of Participants With Disease Activity Score 28 (DAS28) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 52|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455720|NCT00810199|Secondary|Area Under Curve (AUC) DAS28|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. AUC DAS28 was averaged over study days. Analysis of Covariance was adjusted for Baseline DAS28 as a covariate and treatment group and region as fixed factors. Higher calculated AUC values are worse (indicate higher disease activity).|Baseline to Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available at Baseline and Week 24.|||Score on a scale*week||Standard Error|Least Squares Mean
1455721|NCT00810199|Secondary|Time to First ACR90 Response|Time in days from first administration of study drug until ACR90 response. ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
1455722|NCT00810199|Secondary|Time to First ACR70 Response|Time in days from first administration of study drug until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
1455723|NCT00810199|Secondary|Time to First ACR50 Response|Time in days from first administration of study drug until ACR50 response. ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate).|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
1455724|NCT00810199|Secondary|Time to First ACR20 Response|Time in days from first administration of study drug until ACR20 response. ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|104 Weeks|Intent-to treat population included all randomized participants who received study drug. Censoring occurred at the last assessment for those completing the study or withdrawing early, if a response was not observed. In calculating ACR response, a last observation carried forward approach is used for missing joint count data.|||Days||95% Confidence Interval|Median
1455735|NCT00810082|Primary|Participants With at Least One Fall|Subjects who had at least one fall subsequent to treatment.|3 months||||participants|||Number
1455725|NCT00810199|Secondary|Percentage of Participants With ACR90 Response|ACR90 response is defined as a ≥ 90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455726|NCT00810199|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455727|NCT00810199|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455728|NCT00810199|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Weeks 24, 52, 104|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455729|NCT00810199|Primary|Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Week 24|Intent-to-treat population included all randomized participants who received study drug.|||Percentage of participants|||Number
1455730|NCT00810108|Primary|Lopinavir Area Under the Curve (AUC)|Lopinavir Area Under the Plasma Concentration versus Time Curve (AUC)|pre-dose, 1,2,4,6,8, and 12 hours post-dose|All subjects who completed the pharmacokinetic sampling visits with whole tablet administration were analyzed|||mg*hr/L||Inter-Quartile Range|Median
1455731|NCT00810095|Secondary|Number of Device-related Serious Adverse Events|Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory.|Treatment to 90 days postprocedure|Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers.|||events|||Number
1455732|NCT00810095|Primary|Clinical Success|Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent.|90 days postprocedure|Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure.|||percentage of participants|||Number
1455733|NCT00810095|Primary|Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram.|"TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty:~TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow"|Immediately postprocedure|Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram.|||percentage of participants|||Number
1455738|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Visits||Standard Deviation|Mean
1455739|NCT00810069|Secondary|Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks||Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Visits||Standard Deviation|Mean
1455740|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks|Only those participants who missed at least 1 hour of work due to depression were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Hours||Standard Deviation|Mean
1455741|NCT00810069|Secondary|Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks|Only those participants who missed at least 1 hour of work were included.|Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Hours||Standard Deviation|Mean
1455742|NCT00810069|Secondary|Resource Utilisation - Number of Hours Worked Per Week||Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.|||Hours||Standard Deviation|Mean
1455743|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission|Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population|||estimated probability (percent)||95% Confidence Interval|Mean
1455744|NCT00810069|Primary|Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population|||weeks||95% Confidence Interval|Median
1455745|NCT00810069|Secondary|Sheehan Disability Scale (SDS) Normal Functioning Total Score|The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
1455746|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score|The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
1455747|NCT00810069|Secondary|Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score|The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.|Baseline, Week 4, Week 8, Week 12, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
1455748|NCT00810069|Secondary|Visual Analog Scale (VAS) - Overall Pain Severity|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
1455749|NCT00810069|Secondary|Clinical Global Impressions of Severity (CGI-S) Scale|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16|Full Analysis Population|||units on a scale||Standard Deviation|Mean
1455750|NCT00810069|Secondary|Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.|Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population|||weeks||95% Confidence Interval|Median
1455751|NCT00810069|Secondary|Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.|Week 4 through Week 16|Full Analysis Population|||weeks||95% Confidence Interval|Median
1455752|NCT00810069|Primary|Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response|Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Population|||estimated probability (percent)||95% Confidence Interval|Mean
1455753|NCT00810069|Primary|Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)|Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 4 through Week 16|Full Analysis Set|||weeks||95% Confidence Interval|Median
1455754|NCT00810043|Secondary|Change in Ambulatory Status|Ambulatory status was assessed by subjective patient questionnaire.|Baseline and 48 hrs post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||participants|||Number
1455755|NCT00810043|Secondary|Change in Back Pain.|Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||units on a scale||Standard Deviation|Mean
1455756|NCT00810043|Secondary|Deformity Correction Assessed by Local Cobb Angle (LCA)|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||degree||Standard Deviation|Mean
1455757|NCT00810043|Secondary|Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.|Baseline and 48 hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||degree||Standard Deviation|Mean
1455758|NCT00810043|Secondary|Amount of Vertebra Body Height (VBH) Gained by Postural Reduction||baseline and intra-operative|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||mm||Standard Deviation|Mean
1455759|NCT00810043|Secondary|Amount of Vertebral Body Height (VBH) Gained From IBTs Alone|Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.|Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||mm||Standard Deviation|Mean
1455760|NCT00810043|Secondary|Index Vertebral Body Height Restored in Millimeters.|Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.|Baseline and 48 hours after procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment.|||mm||Standard Deviation|Median
1455761|NCT00810043|Primary|Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)||Baseline and 48-hr post-procedure|Modified intention to treat - all randomized patients who received balloon kyphoplasty treatment|||percent change||Standard Deviation|Mean
1455762|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
1455773|NCT00809926|Secondary|Percentage of Responders (Defined as Patients With MSSBP <140 mmHg or a Decrease From Baseline ≥20 mmHg) at Week 8|To compare the percentage of responders (defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||percentage of responders|||Number
1455763|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
1455764|NCT00809965|Secondary|The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
1455765|NCT00809965|Secondary|The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
1455766|NCT00809965|Primary|The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke|The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.|From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)|The Modified Intent-to-Treat (mITT) population consisted of all randomized patients, regardless of treatment exposure, excluding sites 091001, 091019, and 091026 (excluded due to potential trial misconduct). The mITT population was also subject to censoring of events that occurred on, or after, the global treatment end date.|||Percentage of patients|||Number
1455767|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (MADBP)|To evaluate 24-hour ambulatory diastolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the ABPM substudy and who met the study inclusion and exclusion criteria for randomization.|||mm Hg||Standard Deviation|Mean
1455768|NCT00809926|Other Pre-specified|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP).|To evaluate 24-hour ambulatory systolic blood pressure measurements in a subset of patients after 8 weeks of treatment with the combination of valsartan and aliskiren versus valsartan monotherapy in patients with stage 2 hypertension.|Baseline to week 8|Patients who were willing to participate in the Ambulatory Blood Pressure Monitoring (ABPM) substudy and who met the study inclusion and exclusion criteria for randomization.|||mm Hg||Standard Deviation|Mean
1455769|NCT00809926|Other Pre-specified|Longitudinal Repeated Measure Analysis for Change in MSSBP From Baseline Through Week 8|To evaluate the change from baseline in MSSBP (mmHg) after 8 weeks; primary efficacy variable (ITT population) using Longitudinal analysis (A repeated measures analysis where assessments over time are considered , as opposed to looking at a single point in time.)|Baseline through week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||mm Hg||Standard Error|Least Squares Mean
1455770|NCT00809926|Other Pre-specified|Completers Analysis for Change From Baseline in MSSBP at Week 8|To evaluate the change from baseline in MSSBP (mmHg) at Week 8; primary efficacy variable at primary time point in ITT population – patients who completed the double-blind treatment period.|Baseline to week 8|The analysis included ITT patients who completed the double-blind treatment period [those patients with a final observation at week 8, also known as observed cases (OC)]. This analysis differed from the ITT-LOCF analysis, in that it did not include patients who discontinued from the trial prematurely.|||mm Hg||Standard Deviation|Mean
1455771|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Concentration (PRC) at Week 8|To assess the change from baseline in PRC after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||ng/L||Standard Deviation|Mean
1455772|NCT00809926|Secondary|Mean Change From Baseline in Plasma Renin Activity (PRA) at Week 8|To assess the change from baseline in PRA after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||ng/mL/h||Standard Deviation|Mean
1455787|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Days Used Per Week When Used||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – Subjects who used rescue medication at any time during the first two weeks of the study and who used rescue medication at any time during baseline|||Days per Week||Standard Deviation|Mean
1455774|NCT00809926|Secondary|Percentage of Patients Achieving Blood Pressure Control (Defined as Patients Achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at Week 8|To evaluate the percentage of patients achieving blood pressure control (defined as patients achieving a MSSBP <140 mmHg and MSDBP <90 mmHg) at week 8 following treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|At Week 8|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had valid baseline and at least one valid post-baseline assessment of an efficacy variable.|||percentage of patients|||Number
1455775|NCT00809926|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8|To compare the change in MSDBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan (160 mg, 320 mg) treatment regimen in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.|||mm Hg||Standard Deviation|Mean
1455776|NCT00809926|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8|To compare the change from baseline in MSSBP after 8 weeks of treatment with a valsartan and aliskiren treatment regimen (160/150 mg, 320/300 mg) versus a valsartan treatment regimen (160 mg, 320 mg) in patients with Stage 2 Hypertension.|Baseline to Week 8|Intent-to-treat (ITT) population consisted of all randomized patients who received at least 1 dose of study drug and had valid baseline and 1 valid post-baseline assessment of an efficacy variable. The last-observation-carried-forward (LOCF) method was used for replacing the missing values of the post-baseline assessments for ITT analysis at wk 8.|||mm Hg||Standard Deviation|Mean
1455777|NCT00809848|Secondary|Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.|Baseline, Day 14|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation|||Percentage of Patients|||Number
1455778|NCT00809848|Primary|Change From Baseline in Average Eye Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14 Hour 0|Modified Intent to Treat: all randomized and treated patients who had at least a baseline visit and 1 postbaseline IOP evaluation|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
1455779|NCT00809835|Secondary|Cognitive Function|"A composite using a carefully selected neuropsychological battery that includes measures of executive cognitive functioning frequently affected among cocaine users, likely to be important moderators of CBT4CBT, and sensitive to galantamine effects. These will include measures of multiple aspects of attention, cognitive inhibition, sustained attention (CANTAB), decision making (BART), and memory (digit span).~Scores ranged from -1.77 to 1.42 with a higher score indicating higher cognitive functioning."|12 weeks|All participants did not complete the CANTAB assessments at both pre and post treatment. Reasons for not completing were refusal to complete the tasks, inability to complete the tasks in a manner in which they could be scored and equipment or computer problems.|||scores on a scale||Standard Deviation|Mean
1455780|NCT00809835|Primary|Cocaine Abstinence|operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks|12 weeks|Three arm had one subject drop out before study medication was given- therefore the number analyzed are those that received first treatment.|||percentage of negative urines||Standard Deviation|Mean
1455781|NCT00809835|Primary|Cocaine Use|Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.|12 weeks|Presented are data for those measured at baseline and at 12 weeks. 2 individuals in the Galantamine arm were not measured at 12 weeks.|||Days||Standard Deviation|Mean
1455782|NCT00809809|Secondary|Compare Zicam to Placebo on the Incidence of, Speed of, and the Rate of Healing for Aborted Cold Sore Lesions.||14 days|||||||
1455783|NCT00809809|Primary|Zicam Was Compared to Placebo as a Treatment of Recurrent HSL From the Date and Time of the Initiation of Therapy Until the Date and Time of Resolution of the Lesion or After 14 Days of Treatment, Whichever Comes First.|Zinc gluconate swabs were compared as a treatment of recurrent HSL compared to placebo from the date and time of the initiation of therapy until the date and time of resolution of the lesion or after 14 days of treatment, whichever comes first.|14 days|5 subjects met exclusion criteria and were excluded from analysis. 2 subjects used concomitant medications and were excluded from the final analysis. Twelve subjects with recurrent HSL enrolled twice, only the 1st enrollment was included in the analysis. 2 subjects had family enroll who were excluded from analysis. Analysis - 134 subjects.|||Days to resolution||95% Confidence Interval|Median
1455784|NCT00809757|Secondary|Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLA) Composite Score|The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.|Visit 3 and Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Units on a scale||Standard Deviation|Mean
1455785|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used||Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population – subjects who used rescue medication at any time during the first 2 weeks of the study and who had used rescue medication at any time during baseline|||Doses per Week||Standard Deviation|Mean
1455786|NCT00809757|Secondary|Rescue Medication Use – Change From Baseline in Mean Number of Doses Used Per Week||Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population|||Doses per Week||Standard Deviation|Mean
1455788|NCT00809757|Secondary|Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period|Number of subjects using rescue medication during the treatment period|Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)|Intent-to-Treat Population|||Number of subjects|||Number
1455789|NCT00809757|Secondary|Caregiver Global Assessment – Question 3|Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
1455790|NCT00809757|Secondary|Caregiver Global Assessment – Question 2|Since the start of the study, how would you evaluate your ability to manage your child’s asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
1455791|NCT00809757|Secondary|Caregiver Global Assessment – Question 1|Since the start of the study, how would you evaluate your child’s asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
1455792|NCT00809757|Secondary|Investigator Global Assessment – Question 2|Since the start of the study, how would you evaluate your ability to manage the subject’s asthma?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
1455793|NCT00809757|Secondary|Investigator Global Assessment – Question 1|Since the start of the study, how would you evaluate the child’s asthma symptoms?|Visit 4 (End of 28 day treatment period)|Intent-to-Treat Population|||Number of subjects|||Number
1455794|NCT00809757|Secondary|Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
1455795|NCT00809757|Secondary|Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4|Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to <48 months capable of performing acceptable and reproducible PEF maneuvers.|Baseline, Visit 3 (the week prior to Visit 3) and Visit 4|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
1455796|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4||Baseline, Visit 4, pre –dose (approximately 28 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
1455797|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3||Baseline, Visit 3, pre –dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
1455798|NCT00809757|Secondary|Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2||Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||percent change||Standard Deviation|Mean
1455799|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4||Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
1455800|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3||Baseline, Visit 3, pre–dose (approximately 14 days after randomization)|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
1455801|NCT00809757|Secondary|Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2|Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort|Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose|Intent-to-Treat Population – PEF Cohort (Subjects able to perform PEFs)|||liters||Standard Deviation|Mean
1455802|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
1455803|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
1455804|NCT00809757|Secondary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
1455805|NCT00809757|Secondary|Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)|"The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms).~The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
1455806|NCT00809757|Secondary|Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4."|The days from Visit 3 (inclusive) to the day prior to Visit 4 – approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
1455807|NCT00809757|Secondary|Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3."|The days from Visit 2 (inclusive) to the day prior to Visit 3 – approximately 14 days|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
1455808|NCT00809757|Secondary|Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score at Visit 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3."|Baseline, Visit 3 (Week 3)|Intent-to-Treat Population|||units on a scale||Standard Deviation|Mean
1455809|NCT00809757|Primary|Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)|"The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms).~The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4."|Baseline, Visit 4 (Week 4)|Intent-to-Treat Population. Only those subjects who had non-missing data at Week 4 and at Baseline were included. Subjects who discontinued from the study prior to Week 4 are not included in this analysis|||units on a scale||Standard Deviation|Mean
1455810|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||Liters||Standard Deviation|Mean
1455811|NCT00809614|Secondary|PK of AIN457: Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||day*ug/mL||Standard Deviation|Mean
1455812|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||ug/mL||Standard Deviation|Mean
1455813|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Terminal Elimination Half-life (T1/2)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||day||Standard Deviation|Mean
1455814|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Clearance of AIN457 After Single Dose Administration|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic (PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||Liters/day||Standard Deviation|Mean
1455815|NCT00809614|Secondary|Pharmacokinetic (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax)|On dosing days (Day 1 and Day 22) samples were taken at pre-dose (0 h), 2, 3, 4, 24. After the first infusion samples were taken at Day 8 and Day 15. After the second infusion samples were taken at Day 29, Day 43, Day 57, Day 71, Day 85, Day 113, Day 141, Day 169.|Day 1 till end of the study (169)|Only patients who recieved active drug with evaluable pharmacokinetic ( PK) parameter data and no protocol deviation that impacted PK were included in the PK data analysis set|||Day||Full Range|Median
1455816|NCT00809614|Secondary|Disease Activity Score 28 (DA28) in Patients Over Time Per Treatment|The Disease Activity Score (DAS) is a combined index to measure disease activity in arthritic patients. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) Based on the patients global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 - 100). Using the data from these variables, DAS28 is calculated using the following formula: DAS28 = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28 score from 0 to 10 indicating the current activity of the rheumatoid arthritis of the patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.|Baseline, day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Units on a scale||Standard Deviation|Mean
1455817|NCT00809614|Secondary|Leeds Dactylitis Instrument (LDI) Score in Patients Over Time Per Treatment|The LDI basic measured the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference was multiplied by a tenderness score, using a modification of LDI which was a binary score (1 for tender, 0 for non-tender). If both sides were considered involved, the number was compared to data provided in a table. This modification was referred to as LDI basic and was applied in this study. The LDI required a tool to measure digital circumference and this tool was provided to the centers.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|Only participants from the pharmacodynamic (PD) analysis set, who had available scores at each given time point, were analyzed for that time point. The PD analysis set included all patients with evaluable PD data with no protocol deviations that impacted PD data analysis.|||total score||Standard Deviation|Mean
1455818|NCT00809614|Secondary|SpA Research Consortium of Canada (SPARCC) Score Score in Patients Over Time Per Treatment|SPARCC evaluated 18 enthesis sites: medial and lateral epicondyle humerus, supraspinatus insertion, proximal Achilles, greater trochanter, medial and lateral condyl femur, insertion of plantar fascia, quadriceps insertion of patella, inferior pole of patella, and tibial tubercle. SPARCC enthesis index is defined as the total number of painful entheses assessed at the SPARCC sites. Total SI joint scores could range from 0 to 78, with a higher score indicating more signs of disease.|Baseline, Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Unit on a scale||Standard Deviation|Mean
1455819|NCT00809614|Secondary|Psoriatic Area and Severity Index (PASI) Score in Patients Over Time Per Treatment|The PASI assessed the extent of psoriasis on four body surface areas (head, trunk and upper and lower limbs) and the degree of plaque erythema, scaling and thickness. The PASI score accounted for the extent of body surface area affected by the erythema, scaling and thickness, and the severity of these measures. The score ranged from 0 (no disease) to 72 (maximal disease).|Baseline, Day 8, 15 and weeks 6, 8, 12, 16, 20 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Unit on a Scale||Standard Deviation|Mean
1455820|NCT00809614|Secondary|Mastricht Ankylosing Spondylitis Enthesis Score (MASES) Over Time Per Treatment|The MASES included assessments of 13 sites. Enthesitis sites included in the MASES index are: 1st costochondral, 7th costochondral, posterior superior iliac spine, anterior superior iliac spine, iliac crest (all above was assessed bilaterally), 5th lumbar spinous process, proximal Achilles (bilateral). The MASES score is defined as the total number of painful MASES entheses. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline and Day 8, 15 and weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations|||Units on a scale||Standard Deviation|Mean
1455821|NCT00809614|Secondary|Percentage of Participants Who Achieved PsARC Response|"responder defined as 20% or more improvement in at least 4 of 6 criteria: 1) swollen joint count, 2) tender joint count, 3) morning stiffness duration (low back), 4) current low back pain, 5) current peripheral joint pain, 6) patient global assessment A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.|||Percentage of participants|||Number
1455822|NCT00809614|Secondary|Percentage of Participants Who Achieved 20%, 50% or 70% Improvement as Measured by ACR Response Criteria|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|Day 8 and 15, Weeks 6, 8, 12, 16 and 24|For pharmacodynamic (PD) analysis set five patients were excluded due to protocoldeviations.|||Percentage of particpants|||Number
1455823|NCT00809614|Primary|Percentage of PsARC Responders Per Treatment at Week 6|"Psoriatic Arthritis Response Criteria (PsARC) includes measures of tender and swollen joint counts, patient's assessment of pain, physician's and patient's global assessment of disease activity~A subject is defined as a PsARC responder if, and only if, they have an improvement in two of the following four factors (with at least one factor being a joint count) and no worsening in the remaining factors: 1) Patient global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 2) Physician global assessment (0-100 VAS scale, improvement defined as decrease of at least 20 units) 3) Tender 78-joint count (improvement defined as decrease of at least 30%) 4) Swollen 76-joint count (improvement defined as decrease of at least 30%)"|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.|||Percentage of PsARC responders|||Number
1455888|NCT00809133|Secondary|Part D: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State.|AUCt,ss: Area under the concentration-time curve of Afatinib at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455824|NCT00809614|Primary|Percentage of ACR Responders Per Treatment at Week 6|A participant was considered to be a responder according to the ACR20, 50 or 70 criteria if the participant had at least 20% 50% or 70% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)|week 6|For pharmacodynamic (PD) analysis set five patients were excluded due to protocol deviations.|||Percentage of ACR responders|||Number
1455825|NCT00809523|Primary|Percentage Change SIGH SAD Depression Rating|"SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.~Calculated: SIGH SAD score at trial end – SIGH SAD score at randomization x 100 / SIGH SAD score at randomization"|4 weeks|Intent to treat analysis last observation carried forward.|||percentage of change on SIGH SAD||Standard Deviation|Mean
1455826|NCT00809523|Secondary|Clinical Global Impression of Severity|The Clinical Global Impression of Severity is a 7-point scale in which the clinician gives an overall impression of depression severity, with the following anchor points: (1)Normal, not at all ill, (2)Borderline ill, (3) Mildly ill, (4)Moderately ill, (5) Markedly ill, (6)Severely ill, and (7)Among the most severely ill patients. The minimum is therefore 1 and the maximum is 7, which represents very severe depression.|Randomization and at 4 weeks|intent to treat analysis|||units on a scale||Standard Deviation|Mean
1455827|NCT00809523|Secondary|SIGH SAD Depression Rating|SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.|Weekly|Intent to treat analysis last observation carried forward.|||units on a scale||Standard Deviation|Mean
1455828|NCT00809471|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Deviation|Least Squares Mean
1455829|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 Weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
1455830|NCT00809471|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12-weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
1455831|NCT00809458|Secondary|Determine Concordance of the Biomarkers in This Setting|The correlation between the ATQ level and the androgen receptor will be explored.|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.||||||
1455832|NCT00809458|Secondary|Determine the Tolerability/Toxicity of a Short Course of Vitamin E in the Neoadjuvant Setting.|"Cardiovascular Effects/ Thrombophlebitis~Dermatologic Effects~Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps)~Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production~Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis)~Neurologic Effects (Dizziness, headache, fatigue or weakness~Ophthalmic Effects ( Blurred vision)~Respiratory Effects (Pulmonary embolism)"|3 years|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.||||||
1455833|NCT00809458|Primary|Reduce Biomarkers of Prostate Cancer (PSA Blood Level)|PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.|30 days|This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.||||||
1455834|NCT00809445|Secondary|Self-Report of Ever Having Been Tested|The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.|1 month post-randomization|Number reporting having taken an HIV test, whether they received results or not, at one month follow-up. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively|||participants|||Number
1455835|NCT00809445|Secondary|Sharing of Needles Used in Drug Use|Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.|Six months||||n of people changing needle sharing|||Number
1455836|NCT00809445|Primary|Number of Risky Sexual Behaviors|The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).|Six months post-randomization|All randomized participants who provided self-report of number of unprotected sex acts (vaginal or anal sex without a condom) at six-month follow-up are included.|||number of unprotected sex acts||Standard Deviation|Mean
1455837|NCT00809445|Primary|Self-Report Receipt of HIV Test Results|The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.|One month post-randomization|All randomized participants who provided self-report of either receipt or non-receipt of testing results at one month follow-up are included. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively|||participants|||Number
1455838|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Investigator Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."|||percentageof participants||95% Confidence Interval|Number
1455839|NCT00809328|Secondary|Eradication Rate (Bacteriological Response, Data Review Committee Assessment)|"Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100"|Day 3, End of Treatment, Day 15 and Day 29|"Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n  in the measured values was the total participants EXCLUDING ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1455840|NCT00809328|Secondary|The Tendency Toward Clinical Improvement (Investigator Assessment)|The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.|Day 3|Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.|||participants|||Number
1455841|NCT00809328|Secondary|Response Rate (Clinical Response, Investigator Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100"|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1455842|NCT00809328|Primary|Response Rate (Clinical Response, Data Review Committee Assessment)|"Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|End of Treatment, Day 15 and Day 29|"Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n  in the measured values means total participants excluding ones assessed as indeterminate."|||percentage of participants||95% Confidence Interval|Number
1455843|NCT00809276|Primary|To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD|Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.|1 year||||percentage of participants||95% Confidence Interval|Number
1455844|NCT00809185|Secondary|Bone Marrow Morphology and Cytogenetics Pre- and Post-therapy||at 2 years of treatment|||||||
1455845|NCT00809185|Secondary|Laboratory Correlates (Cytotoxic T-cell Populations, S6K1 Levels, GSTT-1 Mutations, and Presence or Absence of HLA-DR15)||at 2 years of treatment|||||||
1455846|NCT00809185|Secondary|Dose- and Non-dose-limiting Toxicities||at end of one cycle (28 days)|||||||
1455847|NCT00809185|Primary|Number of Patients With Either a Major or Minor Erythroid Response(Hemoglobin Change From Baseline Measure)|"Major erythroid response: (1) For patients with a baseline hemoglobin less than 11 g/dL, a major erythroid response is defined as a > 2 g/dL increase in hemoglobin from baseline; or (2) 100% decrease in red blood cell transfusion requirements.~Minor erythroid response: (1) For patients with baseline hemoglobin less than 11 g/dL, a minor erythroid response is defined as an increase in hemoglobin greater than 1 g/dL but less than 2 g/dL from baseline; or (2) > 50% decrease in red blood cell transfusion requirements."|2 years of treatment|All patients enrolled were analyzed.|||participants|||Number
1455889|NCT00809133|Secondary|Part C: Carboplatin Cmax in Cycle 1 and Cycle 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455848|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1 and 2.|"The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36: Baseline, week 12, week 28; ASQoL: Baseline, day 29, week 12, week 8|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
1455849|NCT00809159|Secondary|Change From Baseline in the Health Related Quality of Life (HRQoL) by Using the SF-36 Physical Component, and the ASQoL (Ankylosing Spondylitis Quality of Life Instrument) in Part 1.|"The Short Form (36) Health Survey (SF-36) measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. ASQoL determined subject's quality of life and is comprised of 18 questions (yes or no) to be completed by the subject. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|SF-36:Baseline, week 12, week 28; ASQoL: Baseline, Day 29, week 12, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
1455850|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1 and 2|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Day 8,15,29,week, 6, 10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
1455851|NCT00809159|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Part 1|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 (no tenderness) to 13 (severe tenderness).|Baseline, day 8,15,29,week, 6, 8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Score||Standard Deviation|Mean
1455852|NCT00809159|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Part 1 and 2|The BASDAI consists of a 1 through 10 scale (1 being no problem and 10 being the worst problem), which was used to answer 6 questions pertaining to the 5 major symptoms of AS: Fatigue, Spinal pain, Joint pain / swelling, areas of localized tenderness (called enthesitis, or inflammation of insertion sites of tendons and ligaments), morning stiffness duration, and morning stiffness severity. The physician will globally assess the subject's current disease state using a visual analog scale (VAS) scale with 0 being very good and 100 being very bad.|Baseline, day 8,15,29,week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||95% Confidence Interval|Least Squares Mean
1455853|NCT00809159|Secondary|Mean Change Bath Ankylosing Spondylitis Metrology Index (BASMI) Score in Part 1 and 2|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement|Baseline, day 8,15,29, week 6,8,10,12,16,20,24,28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Score||Standard Deviation|Mean
1455854|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day||Standard Deviation|Mean
1455892|NCT00809133|Secondary|Part C: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State in Cycle 2|AUCt,ss: Area under the concentration-time curve of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455855|NCT00809159|Secondary|PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day||Standard Deviation|Mean
1455856|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters||Standard Deviation|Mean
1455857|NCT00809159|Secondary|PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters||Standard Deviation|Mean
1455858|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters/day||Standard Deviation|Mean
1455859|NCT00809159|Secondary|PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||Liters/day||Standard Deviation|Mean
1455860|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day*ug/mL||Standard Deviation|Mean
1455861|NCT00809159|Secondary|PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||day*ug/mL||Standard Deviation|Mean
1455862|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||ug/mL||Standard Deviation|Mean
1455863|NCT00809159|Secondary|PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded|||ug/mL||Standard Deviation|Mean
1455864|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 and 2|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.|||Days||Full Range|Median
1455890|NCT00809133|Secondary|Part C: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455865|NCT00809159|Secondary|Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1|Serum samples were collected pre-dose 2, 3, 4 and 24 hours after initiation of the infusions (Days 1 and 22), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 and end of study/Week 28.|Week 28|Pharmacokinetic Analysis set: All patients with quantifiable PK measurements and no major protocol deviations with impact on PK data. Due to several discontinuations, the full set of PK parameters could not be obtained in all treated patients. Patients who received only one infusion and/or had a too short PK sampling period were excluded.|||Days||Full Range|Median
1455866|NCT00809159|Secondary|Magnetic Resonance Imaging (MRI) Inflammatory Scores at Baseline, Week 6 in Part 1|The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of ASspiMRI-a (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema (less than25% of DVU; 3=severe bone marrow edema (more that 50% of DVU). The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation|Baseline, week 6, week 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Score||Standard Deviation|Mean
1455867|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 in Part 1 and 2 Combined|a Bayesian model was fitted to the ASAS20 , ASAS40 and ASAS 5/6 response rates on active and placebo treatments. A Bayesian analysis had been chosen to allow the direct incorporation into the analysis of information about placebo response rates from historical data|Day 8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Participants|||Number
1455868|NCT00809159|Secondary|Number of Participants Who Achieved ASAS20, ASAS40, and ASAS 5/6 Over Time in Part 1|ASAS20 responder had improvement of 40% or more and absolute improvement of at least 2 units (scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|Day8,15,29,week 6, 8, 10, 12, 16, 20, 24, 28|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Participants|||Number
1455869|NCT00809159|Primary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score From Baseline to 6 Weeks After First Infusion in Part 2|ASAS20 as described in Primary Outcome. ASAS40 responder had improvement of 40% or more and absolute improvement of at least 2 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with no deterioration in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores). ASAS 5/6 responder had improvement of 20% or more) from Baseline in at least 5 of the following 6 domains: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores); Spinal Mobility (BASFI); Acute phase reactant (CRP)|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 2 due to the absence of available post-baseline PD measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
1455870|NCT00809159|Primary|Percentage of Participants Who Achieved ASAS20 Response|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of 20% or more and absolute improvement of at least 1 units (on a scale of 0 [least] to 10 [worst]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (worsening of at least 20% an absolute Worsening of at least 1 unit) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Function (Bath Ankylosing Spondylitis Functional Index (BASFI)); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] scores|6 Weeks|Pharmacodynamic Analysis set: All patients with a least one evaluable post-treatment PD measurement and no major protocol deviations with impact on PD data were included. One subjects was excluded from the PD set in the AIN457 10mg/kg Part 1 due to protocol deviation|||Percentage|||Number
1455871|NCT00809146|Secondary|Length of Hospital Stay in Days|Continuous acute care inpatient hospital days from day of admission until discharge|participants were followed for the duration of hospital stay, an average of 6 days|All subjects with hospital length of stay data|||days||Standard Deviation|Mean
1455872|NCT00809146|Secondary|Length of Intensive Care Unit (ICU) Stay in Days|Continuous days of initial ICU stay from time of admission|participants were followed for the duration of hospital stay, an average of 6 days|All participants with ICU length of stay data|||days||Standard Deviation|Mean
1455873|NCT00809146|Secondary|Number of Subjects With IV Injection-site Complications|IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care.|participants were followed for the duration of hospital stay, an average of 6 days||||participants|||Number
1455987|NCT00808483|Secondary|Harris Hip Score (HHS)|Pain and physical function. 0 (worse) - 100 (best)|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
1455874|NCT00809146|Secondary|Number of Subjects With IM Injection-site Complications|IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems.|participants were followed for the duration of hospital stay, an average of 6 days||||participants|||Number
1455875|NCT00809146|Secondary|Number of Subjects With Hypotension|Acute hypotension is defined as a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor.|participants were followed for the duration of hospital stay, an average of 6 days||||participants|||Number
1455876|NCT00809146|Secondary|Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival|Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival.|within 12 hours after ED arrival||||participants|||Number
1455877|NCT00809146|Secondary|Number of Subjects Admitted to an Intensive Care Unit (ICU)|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at time of disposition on day of enrollment||||participants|||Number
1455878|NCT00809146|Secondary|Number of Subjects Hospitalized|Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|at ED disposition on day of enrollment||||participants|||Number
1455879|NCT00809146|Secondary|Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival|Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation.|anytime before 30 minutes after ED arrival||||participants|||Number
1455880|NCT00809146|Primary|Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given|The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing.|Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).||||participants|||Number
1455881|NCT00809133|Secondary|Objective Tumour Response (Confirmed)|"Number of subjects with confirmed objective tumour response.~Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR). Objective response was to be confirmed by a second tumour assessment at least 4 weeks after the assessment of CR or PR."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
1455882|NCT00809133|Secondary|Objective Tumour Response (Unconfirmed)|"Number of subjects with objective tumour response (unconfirmed).~Objective Response (OR) was defined as Complete Response (CR) or Partial Response (PR)."|From first drug administration until the last trial drug administration, up to 1156 days.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
1455883|NCT00809133|Secondary|Part D: Carboplatin Cmax in Cycle 1 and 2|Maximum measured concentration of Carboplatin in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455884|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Carboplatin in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours in Cycle 1 and Cycle 2|AUC0-24: Area under the concentration-time curve of Carboplatin in plasma over the time interval from zero extrapolated to 24 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455885|NCT00809133|Secondary|Part D: Paclitaxel Cmax in Cycle 1 and 2|Maximum measured concentration of Paclitaxel in plasma.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455886|NCT00809133|Secondary|Part D: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 23 Hours in Cycle 1 and Cycle 2|AUC0-23: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 23 hours.|Cycle 1, day 1 and cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 23:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455887|NCT00809133|Secondary|Part D: Afatinib Cmax,ss|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455891|NCT00809133|Secondary|Part C: Afatinib Cmax,ss in Cycle 2|Maximum measured concentration of Afatinib in plasma at steady state.|Cycle 2, day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455893|NCT00809133|Secondary|Part B: Bevacizumab Plasma Concentration|Bevacizumab plasma concentration after infusion of Bevacizumab 5mg/kg after end of 1st and 2nd infusion in Cycle 1.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||μg/mL||Inter-Quartile Range|Median
1455894|NCT00809133|Secondary|Part B: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455895|NCT00809133|Secondary|Part B: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From 0 Extrapolated Upto 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455896|NCT00809133|Secondary|Part B: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455897|NCT00809133|Secondary|Part B: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. There were no analyzable patients for Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455898|NCT00809133|Secondary|Part A: Paclitaxel Cmax on Day 1 and Day 15|Maximum measured concentration of Paclitaxel in plasma.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455899|NCT00809133|Secondary|Part A: AUC0-24: Area Under the Concentration-Time Curve of Paclitaxel in Plasma Over the Time Interval From Zero Extrapolated to 24 Hours on Day 1 and Day 15|AUC0-24: Area under the concentration-time curve of Paclitaxel in plasma over the time interval from zero extrapolated to 24 hours.|Day 1: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00. Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455900|NCT00809133|Secondary|Part A: Afatinib Cmax,ss on Day 15|Maximum measured concentration of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1455901|NCT00809133|Secondary|Part A: AUCt,ss: Area Under the Concentration-Time Curve of Afatinib in Plasma at Steady State on Day 15|Area under the concentration-time curve of Afatinib in plasma at steady state.|Day 15: -0:05 (hh:mm), 0:00, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00 and 24:00.|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1455902|NCT00809133|Secondary|Incidence and Intensity of AEs According to the Maximum Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade|Incidence and Intensity of AEs (Adverse Events) graded according to the maximum CTCAE (Common Toxicity Criteria for Adverse Events) grade based on the number of patients with AEs with CTCAE Grade 1-5.|From first drug administration until the end of treatment cycle 1; 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
1455903|NCT00809133|Primary|Maximum Tolerated Dose (MTD)|"The MTD of afatinib in selected combination treatments was defined as the highest dose at which no more than 1 out of 6 patients experienced DLTs during the first treatment cycle, i.e. the highest dose with a DLT incidence ≤17%. The MTD was determined separately for Afatinib in combination with Paclitaxel (part A), Afatinib in combination with Paclitaxel and Bevacizumab (part B), Afatinib and Carboplatin (part C), and Afatinib in combination with Paclitaxel and Carboplatin (part D).~In part C, dose escalation was not continued beyond the dose level A40C6, due to safety and pharmacokinetic considerations and upon mutual agreement between the investigators and the sponsor. Formally, no MTD was determined, however a recommended phase II dose was determined and is presented here.~0=not maximum tolerated dose, 1=is maximum tolerated dose~Note, the depicted order of treatment groups is driven by dose level, not by the actual dosing steps."|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Units on a scale|||Number
1455904|NCT00809133|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Dose limiting toxicity (DLT) was defined as an Adverse Event (AE) or laboratory abnormality considered as related to study treatment.|Cycle 1: 21 days (part C and D) or 28 days (part A and B)|Treated Set: Patients who received at least 1 dose of study treatment were included in the treated set.|||Participants|||Number
1455905|NCT00809094|Other Pre-specified|Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group|Change in measure of estimated right ventricular pressure over the 24-week study period|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects. 1 subject in NAC cohort has missing data. It was not imputed|||mm Hg||Standard Deviation|Mean
1455906|NCT00809094|Other Pre-specified|Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group|Change in the diffusing capacity of carbon monoxide across the lung measured from baseline to end of 24-week study.|Baseline to 24 weeks|Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects.|||ml/min/mm Hg||Standard Deviation|Mean
1455907|NCT00809094|Secondary|FEF 25-75% (Percent of Predicted)|Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to the end of study (24 weeks).|Baseline to 24 weeks|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||percent of predicted||95% Confidence Interval|Mean
1455908|NCT00809094|Secondary|FEF 25-75% (L/Sec)|Difference in mid-expiratory flow rates between 25 to 75% of the vital capacity, in L/sec measured at the beginning of the study to the end of the study.|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||L/sec||95% Confidence Interval|Mean
1455909|NCT00809094|Secondary|FEV1 (L)|Forced expiratory volume in 1 second (Liters)|Baseline to end of study (24 weeks)|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||Liter||95% Confidence Interval|Number
1455910|NCT00809094|Secondary|Change in FEV1 (Percent of Predicted for Age)|Change in forced expiratory volume in 1 second as compared to normals for age (percent of predicted)|From enrollment to the end of the 24-week trial|Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||percent of predicted vlaues||95% Confidence Interval|Number
1455911|NCT00809094|Primary|Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum|(change in log10 HNE in the active treatment group) – (change in log10 HNE in the placebo group)|From enrollment to end of the 24-week trial|The primary endpoint analyses described uses the subset of the ITT population with complete case data. 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.|||log10 mcg/mL||95% Confidence Interval|Log Mean
1455912|NCT00809055|Secondary|Bayley Scales of Infant Development Cognitive Score at 2 Years of Age|The cognitive portion of the Bayley Scales of Infant Development assesses development in infants and toddlers between the ages of 0 and 3 years. Raw scores are converted to scale scores. A scale score of 100 is designed to represent the population mean. Scores below 100 represent developmental delay relative to the mean and scores above 100 represent advanced development relative to the mean.|2 years|13 patients excluded from high-dose group (7 died, 2 withdrew, 2 we were unable to contact, 2 did not comply with scheduled appointments). 15 patients excluded from standard-dose group (5 died, 2 withdrew, 5 we were unable to contact, 3 did not comply with scheduled appointments).|||score||Standard Deviation|Mean
1455913|NCT00809055|Secondary|Infant Neurobehavioral Scoring by Dubowitz Scale Prior to Discharge|The Dubowitz Neurologic Examination is a standardized neurologic examination for infants at term age. It includes 6 compound optimality scores summed to obtain the total optimality score. Compound optimality scores include tone (range 0-10), tone pattern (range 0-5), reflexes (range 0-6), movements (range 0-3), abnormal signs (range 0-3), and behavior (range 0-7). The range for the compound optimality score is 0 - 34, with scores between 30.5 and 34 considered optimal and scores below 30.5 considered suboptimal.|Participants were followed for the duration of hospital stay, an average of 12 weeks|9 patients excluded from high-dose group (7 died, 2 withdrew). 6 patients excluded from standard-dose group (5 died, 1 transferred).|||scores on a scale||Standard Deviation|Mean
1455914|NCT00809055|Secondary|Evaluation of EEG Seizure Burden|For the first 72 hours of life, infants were monitored for seizures using continuous limited channel aEEG. Seizures were defined as a series of sharp waves, at least ten seconds in duration, which evolve in frequency, amplitude, and morphology over time and are clearly distinguishable from the background or artifact.|First 72 hours of life|7 patients excluded from high-dose group and 8 from standard-dose group due to recordings < 6 hours or corrupt data files.|||seconds||Standard Deviation|Mean
1455915|NCT00809055|Secondary|Rates of Retinopathy of Prematurity||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
1455916|NCT00809055|Secondary|Rates of Necrotizing Enterocolitis||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
1455917|NCT00809055|Secondary|Rates of Chronic Lung Disease|Defined as oxygen requirement at 36 weeks PMA|Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
1455918|NCT00809055|Secondary|Length of Time Requiring Invasive Respiratory Support||Participants were followed for the duration of hospital stay, an average of 12 weeks||||days||Inter-Quartile Range|Median
1455919|NCT00809055|Secondary|Cerebellar Hemorrhage||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
1455920|NCT00809055|Secondary|Mortality Rates||Participants were followed for the duration of hospital stay, an average of 12 weeks||||participants|||Number
1455921|NCT00809055|Primary|White Matter Microstructural Maturation|Apparent diffusion coefficient is a measure of microstructural maturation obtained from brain MRI.|Participants were followed for the duration of hospital stay, an average of 12 weeks|12 patients excluded from high-dose group (7 died, 2 withdrew, 3 insufficient image quality). 10 patients excluded from standard-dose group (5 died, 1 transferred, 1 parent refused MRI, 3 insufficient image quality).|||apparent diffusion coefficient||Standard Deviation|Mean
1455922|NCT00808899|Primary|Complete Response Plus Partial Response|The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.|10 years|The population consisted of patients eligible for enrollment onto the NB2008 protocol.||||||
1455923|NCT00808834|Primary|Comfort After Insertion|Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.|30-60 seconds after initial insertion|Per protocol|||Scale 1-10||Standard Deviation|Mean
1455988|NCT00808483|Secondary|Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)|Self-reported symptoms, pain, physical function, function in sport and recreation, quality of life. 0 (worse) - 100 (best)|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
1455924|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist|||percent|||Number
1455925|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist|||percent|||Number
1455926|NCT00808808|Secondary|Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race|Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white|30Sep2008 through 23Dec2008|All participants who completed surveys and were eligible to receive FluMist|||percent|||Number
1455927|NCT00808808|Secondary|Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season||30Sep2008 through 23Dec2008|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not|||percent|||Number
1455928|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not|||percentage points|||Number
1455929|NCT00808808|Secondary|Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population|Rate difference by arm from baseline to intervention season|2007-2008 season through 2008-2009 season|All vaccinated employees at participating sites, including those who completed surveys and those who did not|||percentage points|||Number
1455930|NCT00808808|Primary|Overall Vaccination Rate, Employees 18 to 49 Years of Age||30Sep2008 through 23Dec2008|All vaccinated employees at participating sites, including those who completed surveys and those who did not|||Percentage of participants|||Number
1455931|NCT00808808|Primary|Overall Vaccination Rate, All Ages||30Sep2008 through 23Dec2008|All employees at participating sites, including those who were vaccinated and those who were not|||Percentage of participants|||Number
1455932|NCT00808769|Primary|The Mean Percent Time Gastric pH > 4.0 on Day 1|In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.|continuously over a 24 hour period|Zeros are entered because the data are corrupted for 2 reasons: probe calibration failure rate was ~10x higher than historically documented, and the probes that calibrated had a high incidence of prolonged pH < 1.0 (highly physiologically improbable). This calls into question the credibility and interpretability of all the pH data.||||||
1455933|NCT00808665|Primary|Time Required After Surgery to Reach Fitness for Discharge From Hospital||Start of study drug to time to reach fitness for discharge from hospital (about 3 to 5 days)|analysis done on the 54 participants that received the entire course of Dexmedetomidine or placebo.|||days||Inter-Quartile Range|Median
1455934|NCT00808639|Secondary|Number of Patients Experiencing Surgery-related Toxicity|Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.|Surgery + 30 days|Number of patients who underwent cystectomy.|||participants||90% Confidence Interval|Number
1455935|NCT00808639|Secondary|Number of Patients Experiencing Febrile Neutropenia|Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)||||participants||90% Confidence Interval|Number
1455936|NCT00808639|Primary|Number of Patients Achieving Pathologic Response|Pathological response is defined as down-staging to </=pT1, N0 after chemotherapy with pegfilgrastim support.|After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)|Analysis population consists of all enrolled patients.|||percentage of pathologic responders||90% Confidence Interval|Number
1455937|NCT00808509|Secondary|Change From Baseline in Radiological Modified Total Sharp Score|The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at Baseline, Week 52 and the Week 104-156 visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline, Week 52, and Weeks 104-156|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1455938|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Daily Activities|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 6 asks participants to indicate how much their rheumatoid arthritis affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying, etc, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1455939|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Work Productivity|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 5 asks participants who are employed or working for pay to indicate how much their rheumatoid arthritis impaired their productivity while working in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from working).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.|||units on a scale||Standard Deviation|Mean
1455940|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Worked|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 4 asks participants who are employed or working for pay to indicate the number of hours actually worked during the past 7 days.|Baseline and at Weeks 12, 28, 52 and 104-156|Full analysis set participants employed or working for pay and with available data at each time point.|||hours||Standard Deviation|Mean
1455941|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work for Other Reasons|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 3 asks participants who are employed or working for pay to indicate the number of hours missed from work due to reasons other than rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.|||hours||Standard Deviation|Mean
1455942|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Hours Missed From Work|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 2 asks participants who are employed or working for pay to indicate the number of hours missed from work due to problems associated with their rheumatoid arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set participants employed or working for pay; N indicates the number of participants employed or working for pay and with available data at each time point.|||hours||Standard Deviation|Mean
1455943|NCT00808509|Secondary|Work Productivity and Activity Impairment (WPAI): Currently Employed|The Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire was used to assess work and activity impairment due to symptoms of rheumatoid arthritis in the last 7 days. The self-administered questionnaire consists of 6 questions. Question 1 asks participants to indicate if they are currently employed or working for pay (Yes or No).|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455944|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'd Like Another Job But I am Restricted to What I Can do|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 23, participants selected either Yes or No if the following statement currently applied to them or not: I'd like another job but I am restricted to what I can do.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455945|NCT00808509|Secondary|Work Instability Score (WIS) for RA: When I'm Feeling Tired All the Time Work is a Grind|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 22, participants selected either Yes or No if the following statement currently applies to them or not: When I'm feeling tired all the time work is a grind.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455946|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get on With the Work But Afterwards I Have a Lot of Pain|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 21, participants selected either Yes or No if the following statement currently applies to them or not: I get on with the work but afterwards I have a lot of pain.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455947|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Feel I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 20, participants selected either Yes or No if the following statement currently applies to them or not: I feel I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455948|NCT00808509|Secondary|Work Instability Score (WIS) for RA: It's Very Frustrating Because I Can't Always do Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 19, participants selected either Yes or No if the following statement currently applies to them or not: It's very frustrating because I can't always do things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455949|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Allow Myself Extra Time to do Some Jobs|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 18, participants selected either Yes or No if the following statement currently applies to them or not: I have to allow myself extra time to do some jobs.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455950|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Great Difficulty Opening Some of the Doors at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 17, participants selected either Yes or No if the following statement currently applies to them or not: I have great difficulty opening some of the doors at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455951|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I've Got to Watch How Much I do Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 16, participants selected either Yes or No if the following statement currently applies to them or not: I've got to watch how much I do certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455952|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have to Say No to Certain Things at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 15, participants selected either Yes or No if the following statement currently applies to them or not: I have to say no to certain things at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455953|NCT00808509|Secondary|Work Instability Score (WIS) for RA: Sometimes I Can't Face Being at Work All Day|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 14, participants selected either Yes or No if the following statement currently applies to them or not: Sometimes I can't face being at work all day.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455954|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Push Myself to go to Work Because I Don't Want to Give in to the Arthritis|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 13, participants selected either Yes or No if the following statement currently applies to them or not: I push myself to go to work because I don't want to give in to the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455955|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Used my Vacation so That I Don't Have to Take Sick Leave|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 12, participants selected either Yes or No if the following statement currently applies to them or not: I have used my vacation so that I don't have to take sick leave.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455956|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Don't Have the Stamina to Work Like I Used to|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 11, participants selected either Yes or No if the following statement currently applies to them or not: I don't have the stamina to work like I used to.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455957|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Have Pain or Stiffness All the Time at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 10, participants selected either Yes or No if the following statement currently applies to them or not: I have pain or stiffness all the time at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455958|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I am Very Worried About my Ability to Keep Working|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 9, participants selected either Yes or No if the following statement currently applies to them or not: I am very worried about my ability to keep working.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455959|NCT00808509|Secondary|Work Instability Score (WIS) for RA: If I Don't Reduce my Hours I May Have to Give up Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 8, participants selected either Yes or No if the following statement currently applied to them or not: If I don't reduce my hours I may have to give up work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455960|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Can Get my Job Done, I'm Just a Lot Slower|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 7, participants selected either Yes or No if the following statement currently applied to them or not: I can get my job done, I'm just a lot slower.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455961|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Good Days and Bad Days at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 6, participants selected either Yes or No if the following statement currently applied to them or not: I get good days and bad days at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455962|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding Any Pressure on my Hands is a Problem|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 5, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding any pressure on my hands is a problem.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455963|NCT00808509|Secondary|Work Instability Score (WIS) for RA: The Stress of my Job Makes my Arthritis Flare|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 4, participants selected either Yes or No if the following statement currently applied to them or not: The stress of my job makes my arthritis flare.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455964|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Finding my Job is About All I Can Manage|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 3, participants selected either Yes or No if the following statement currently applied to them or not: I'm finding my job is about all I can manage.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455965|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I Get Very Stiff at Work|Work Instability (defined as the mismatch between the person's abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 2, participants selected either Yes or No if the following statement currently applied to them or not: I get very stiff at work.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455966|NCT00808509|Secondary|Work Instability Score (WIS) for RA: I'm Getting up Earlier Because of Arthritis|Work Instability (defined as the mismatch between the person’s abilities and the demands of work) Score is a 23-item questionnaire designed to indicate the participant's level of risk for work disability. In question 1, participants selected either Yes or No if the following statement currently applied to them or not: I'm getting up earlier because of the arthritis.|Baseline and at Weeks 12, 28, 52, and 104-156|Full analysis set|||participants|||Number
1455967|NCT00808509|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale by Visit|The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data.|||units on a scale||Standard Deviation|Mean
1455968|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) by Visit|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (0) and 'Best imaginable health state' (100).|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1455969|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their anxiety/depression health state:~Level 1: I am not anxious or depressed;~Level 2: I am moderately anxious or depressed;~Level 3: I am extremely anxious or depressed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
1455970|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their pain/discomfort health state:~Level 1: I have no pain or discomfort;~Level 2: I have moderate pain or discomfort;~Level 3: I have extreme pain or discomfort."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
1455971|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state with regard to usual activities (work, study, housework, family, or leisure activities):~Level 1: I have no problems performing my usual activities;~Level 2: I have some problems performing my usual activities;~Level 3: I am unable to perform my usual activities."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
1455972|NCT00808509|Primary|Percentage of Participants in Remission at Week 28 in the Full Analysis Set 2 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set 2 (FAS2), defined as participants in the full analysis set who completed at least 28 weeks of the study or completed the study until flare, whichever occurs first.|||percentage of participants||95% Confidence Interval|Number
1455973|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Self-care Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their self-care health state:~Level 1: I have no problems with self-care;~Level 2: I have some problems washing or dressing myself;~Level 3: I am unable to wash or dress myself."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
1455974|NCT00808509|Secondary|European Quality of Life-5 Dimensions (EQ-5D) Mobility Score by Visit|"The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their mobility health state:~Level 1: I have no problems in walking about;~Level 2: I have some problems in walking about;~Level 3: I am confined to bed."|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set|||participants|||Number
1455989|NCT00808483|Primary|6 Minutes Walk Test (6MWT)|Participants walked in a 40 meter hospital corridor for 6 minutes.|5 months and 12 months||||meters||95% Confidence Interval|Mean
1456002|NCT00808444|Secondary|Occurrence of Serious Adverse Events|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|Following vaccination and throughout the entire study period (Month 0 to Month 4)|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||subjects|||Number
1455975|NCT00808509|Secondary|Health Assessment Questionnaire (HAQ) Total Score by Visit|Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52, and 104-156 (extension period visit)|Full analysis set; N indicates the number of participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
1455976|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (DAS28 <2.6 or DAS28 Decrease >1.2 Units) After a Flare|For participants with a flare and treated with adalimumab rescue therapy, response was defined as DAS28 less than 2.6 or DAS28 decrease of greater than 1.2 units after reinstitution of adalimumab (rescue therapy). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.|||percentage of participants||95% Confidence Interval|Number
1455977|NCT00808509|Secondary|Percentage of Participants With Response to Adalimumab Treatment (Return to Baseline DAS28 + ≤ 10%) After a Flare|"For participants with a flare and treated with adalimumab rescue therapy, response was defined as return to Baseline DAS28 + ≤ 10% after reinstitution of adalimumab (rescue therapy).~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity."|1 to 4 weeks, 5 to 8 weeks, 9 to 12 weeks, and 13 to 16 weeks after reinstitution of adalimumab rescue therapy|Full analysis set participants in the methotrexate treatment group with a flare who were reinstituted adalimumab rescue therapy.|||percentage of participants||95% Confidence Interval|Number
1455978|NCT00808509|Secondary|Number of Participants With a Flare|Flare is defined as DAS28 ≥2.6 or an increase from Baseline in the DAS28 of greater than 1.2 units. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, and 52|Full analysis set; N indicates the number of participants with available data at each time point.|||participants|||Number
1455979|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52 (FAS2)|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Also, participants who did not complete 52 weeks were considered not in remission.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52."|Week 52|Full analysis set 2|||percentage of participants||95% Confidence Interval|Number
1455980|NCT00808509|Secondary|Percentage of Participants in Remission at Week 52|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 52 were considered not to be in remission at Week 52. Also, participants who did not complete 52 weeks were considered not in remission."|Week 52|Full analysis set|||percentage of participants||95% Confidence Interval|Number
1455981|NCT00808509|Primary|Percentage of Participants in Remission at Week 28|"Remission is defined as a Disease Activity Score (DAS)28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein (CRP), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.~In this analysis participants in the methotrexate treatment group with a DAS28 score ≥ 2.6 (and thus allocated to rescue therapy with adalimumab) prior to Week 28 were considered not to be in remission at Week 28. Also, participants who did not complete 28 weeks were considered not in remission."|Week 28|Full analysis set (FAS), defined as all participants who received at least one dose of adalimumab and/or methotrexate and had at least one post-baseline observation.|||percentage of participants||95% Confidence Interval|Number
1455982|NCT00808483|Secondary|Figure-of-eight Test|Test of dynamic balance. Number of steps on and outside the line is registered. 0 (best)|5 months and 12 months||||steps||95% Confidence Interval|Mean
1455983|NCT00808483|Secondary|Index of Muscle Function (IMF)|Tests of general mobility, muscle strength, balance/coordination, and endurance. 40 (worse) - 0 (best)|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
1455984|NCT00808483|Secondary|ROM Extension|Active range of motion (ROM) in hip extension test. Degrees is registered. 0 degrees indicates zero position of the hip, minus digrees indicates flexion contracture.|5 months and 12 months||||degrees||95% Confidence Interval|Mean
1455985|NCT00808483|Secondary|Stair Climbing Test (ST)|Ascend and descend 8 steps with a step hight of 16 cm as fast as they could without running. Few seconds (best) - many seconds (worse)|5 months and 12 months||||seconds||95% Confidence Interval|Mean
1455986|NCT00808483|Secondary|Self-efficacy|Self-reported self-efficacy in activities. 0 (worse) - 100 (best).|5 months and 12 months||||units on a scale||95% Confidence Interval|Mean
1455990|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Pairs|Distortion Product Otoacoustic Emission (DPOAE) Amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10dB lower than F1 Levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. The OAE testing began as soon as threshold testing completed. Threshold tests take approximately 15 min, but the exact duration of testing varies among subjects. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier than for others (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).|15 minutes|||||||
1455991|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - Additional Time Measures|DPOAE amplitude was measured following the audiometric testing completion at each of the post-music test times. F1 and F2 frequency pairs included 6656 and 8015 Hz, 5016 and 6000 Hz, 3328 and 3984 Hz, 2484 and 3000 Hz, and 1687 and 2015 Hz. F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels.|repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|||||||
1455992|NCT00808470|Other Pre-specified|Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, 8, kHz||repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|||||||
1455993|NCT00808470|Other Pre-specified|Distortion Product Otoacoustic Emission (DPOAE) Amplitude - f1+3328 HZ, F2+ 3984 Hz; 30 Minutes|DPOAE amplitude was measured following the audiometric testing completion at approximately 30 minutes post music. Test time was approximate as DPOAE tests began as soon as threshold testing was completed. F1 and F2 frequency pairs included 3328 and 3984 Hz, F1 sound levels started at 65 dB SPL at each frequency, and decreased in 5 dB steps to a level of 25 dB SPL. F2 levels were 10 dB lower than F1 levels. Threshold tests began precisely at 15 min, 1 hr 15 min, 2 hr 15 min, 3 hr 15 min. Threshold tests take approximately 15 min, but the exact duration of testing varies from subject to subject. The OAE testing began as soon as threshold testing completed. Thus, OAE tests began approx. 30 min, 1 hr 30 min, 2 hr 30 min, and 3 hr 30 min post music, but for some it may have been a little bit earlier or a little bit later (i.e., the test may have begun as early as 25 min or as late as 35 min post music, depending on how quickly the subject completed threshold testing).|15 min|Data for one participant in the placebo group is incomplete.|||decibels (dB)||Standard Deviation|Mean
1455994|NCT00808470|Secondary|Tinnitus|Presence of tinnitus was assessed using yes/no question. If tinnitus was reported, perception was assessed using survey.|immediate, repeated measures at 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|all participants completing music exposure completed tinnitus surveys.|||participants|||Number
1455995|NCT00808470|Secondary|Threshold Shift at Individual Frequencies, Including 0.25, 0.5, 1, 2, 3, 6, and 8 kHz, 15 Min Post-music|The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.|15 min|all participants that completed music exposure were assessed; two participants withdrew prior to music exposure.|||decibels||Standard Deviation|Mean
1455996|NCT00808470|Primary|Average Threshold Shift at 4 kHz in Both Ears|The study measures the quietest decibel level the participants can hear before the 4 hour music exposure The first post-music test to measure shift is 15 minutes after the music exposure is completed and again at 1 hour intervals. The shift represents the mean change in quietest decibel volume detected between baseline (pre-music) and post music.|15 min, 1 hr intervals for 3 hours to measure temporary changes; additional tests at 1 day and 1 week post-exposure.|All subjects that completed music exposure were analyzed; two subjects withdrew from study prior to music exposure.|||decibels||Standard Deviation|Mean
1455997|NCT00808444|Secondary|Occurrence of Unsolicited Adverse Events|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days (day 0-30) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1455998|NCT00808444|Secondary|Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)|Concentrain was expressed as GMC in µg/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1455999|NCT00808444|Secondary|Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)|Concentrations are expressed as GMCs in EL.U/mL.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Least Squares Mean
1456000|NCT00808444|Secondary|Number of Subjects With Solicited Local and General Symptoms.|"Solicited local symptoms were pain, redness and swelling.~Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting."|Within 4 days (day 0-3) after vaccination|Analysis was performed on the Total Vaccinated Cohort, which inlcuded all vaccinated subjects.|||Participants|||Count of Participants
1456001|NCT00808444|Secondary|Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes|"Titers are presented as Geometric Mean Titers (GMTs).~Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1456003|NCT00808444|Secondary|Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)|Concentration was expressed as GMC in units per milliliter (U/mL).|3 months after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||U/mL||95% Confidence Interval|Geometric Mean
1456004|NCT00808444|Secondary|Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).|Concentration was given as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete reanalysis.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1456005|NCT00808444|Secondary|Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)|Concentrations were defined as GMCs in international units per milliter (IU/mL)|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1456006|NCT00808444|Secondary|Poliovirus Types 1, 2 and 3 Titers|Titers were given as Geometric Mean Titers (GMTs).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1456007|NCT00808444|Secondary|Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes|"Opsonophagocytic titers were expressed as GMTs.~Cross-reactive pneumococcal serotypes included 6A and 19A."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1456008|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes|"Cross-reactive pneumococcal serotypes were 6A and 19A.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1456009|NCT00808444|Secondary|Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes|"Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.~Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1456010|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL|Anti-pneumococcal cross-reactive serotypes were 6A and 19A.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1456011|NCT00808444|Secondary|Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL|Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||Participants|||Count of Participants
1456012|NCT00808444|Primary|Concentration of Antibody Against Protein D (PD)|Concentration was expressed as GMC in GSK’s 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1456013|NCT00808444|Primary|Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine|"Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL).~Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F."|One month after primary immunization (month 4)|Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1456014|NCT00808405|Secondary|Time to First Negative Herpes Simplex Virus (HSV) DNA PCR|To examine the time to first negative HSV DNA PCR among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.|||Days||Standard Error|Mean
1456015|NCT00808405|Primary|Time to Healing of Genital Lesions|To examine time to healing of genital lesions among women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative, and who are randomized to 400mg acyclovir or matching placebo|Days 1-5, 7, 9, 11, 13|Eligible women were 18-50 years of age, HIV-1 seronegative, HSV-2 seropositive and who presented to the study clinic with a new genital ulcer. Intention to treat analysis was used.|||Days||Standard Error|Mean
1456016|NCT00808340|Primary|Overall Subjective Vision|Subject rated the overall quality of vision with the study contact lenses. 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|after 1 week of lens wear, for each lens type||||Units on a scale||Standard Error|Least Squares Mean
1456017|NCT00808340|Primary|Type of Corneal Staining|Investigator rated type of corneal staining as either 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced, or 4=patch(> or = to mm).|after 1 week of lens wear, for each lens type||||Units on a scale||Standard Error|Least Squares Mean
1456018|NCT00808340|Primary|Near Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting reading charts near to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion||||logMAR||Standard Error|Least Squares Mean
1456019|NCT00808340|Primary|Distance Bright Illumination Binocular Visual Performance Reported as Visual Acuity|Tested with both eyes together in bright lighting, reading charts distant to the subject. This outcome is measured in logMAR units.LogMAR stands for the logarithm of the minimum angle of resolution. Ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|5 minutes after insertion||||logMAR||Standard Error|Least Squares Mean
1456020|NCT00808249|Secondary|Change in Sheehan Disability Scale (SDS) Global Total Score|The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired)|From baseline ( randomization) to week 4||||Units on scale||Standard Error|Least Squares Mean
1456021|NCT00808249|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score|The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms|From baseline ( randomization) to week 4||||Units on scale||Standard Error|Least Squares Mean
1456022|NCT00808249|Secondary|Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score|The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms.|From baseline (randomization) to week 4||||Unit on scale||Standard Error|Least Squares Mean
1456023|NCT00808249|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms.|From randomization (baseline) to week 4||||Units on scale||Standard Error|Least Squares Mean
1456024|NCT00808249|Primary|Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.|From randomization (baseline) to week 4||||Units on scale||Standard Error|Least Squares Mean
1456025|NCT00808236|Post-Hoc|Outcomes for Patients Receiving EMS CPR Within 10 Minutes of Collapse That Were Admitted to the Hospital||Hospital Discharge|Subset of patients that received EMS CPR within 10 minutes of collapse, achieved ROSC, and were subsequently admitted to the hospital.|||participants|||Number
1456026|NCT00808236|Post-Hoc|Outcomes for VF Patients Admitted to the Hospital|Survival and neurologically-intact survival for patients found in VF/VT admitted to the hospital|Hospital discharge|Subset of patients with an initial rhythm of VF/VT, achieved ROSC and were subsequently admitted to the hospital|||participants|||Number
1456027|NCT00808236|Post-Hoc|Outcomes for Patients Admitted to the Hospital|Suvival and neurologically intact survival|Hospital discharge|Subset of patients that achieved ROSC and were subsequently admitted to the hospital.|||participants|||Number
1456028|NCT00808236|Secondary|24-hour Adverse Events (AE)|These were all non-serious adverse events that occurred between the time of enrollment and 24 hours after resuscitation. These did not include a failure to achieve ROSC.|24 hours after arrest|all enrolled participants|||all participants|||Number
1456029|NCT00808236|Secondary|Serious Adverse Events (SAEs)|These were defined serious adverse events that are not direct sequelae of the cardiac arrest itself or the underlying cardiac disease. Therefore, these do not include recurrent arrests occcuring within 24 hours of resuscitation nor deaths due to lack of cardiac and/or neurological recovery.|7 days after arrest|"All enrolled patients; see additional modified at risk population based on study attrition in the Adverse Event section."|||all participants|||Number
1456030|NCT00808236|Post-Hoc|Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse|ROSC, Survival, and neurologically-intact survival|Hospital discharge|Subset of patients receiving EMS CPR within 10 minutes of collapse (representing 75% of all patients)|||participants|||Number
1456031|NCT00808236|Secondary|Length of Stay|"Length of stay data for patients admitted to the hospital will be calculated for:~Days on ventilator~Days in intensive care without ventilator~Days in general ward"|Hospital Discharge|Evaluable patients admitted to the hospital|||days||Inter-Quartile Range|Median
1456032|NCT00808236|Secondary|Time to Therapeutic Temperature|The therapeutic temperature range for treatment in cardiac arrest is considered to be 32-34C. Time to therapeutic temperature was taken as the first time in which 34C was measured. Tympanic and core temperatures were taken in all patients.|within 8 hours after enrollment|The subset of patients that were resuscitated and subsequently received in-hospital cooling and reached the designated therapuetic temperatures.|||minutes||Inter-Quartile Range|Median
1456033|NCT00808236|Secondary|Primary Outcomes in Sub-group With VF/VT as First Rhythm|ROSC, survival, and neurologically-intact survival|hospital discharge|Subset of all included patients with VF/VT as the first cardiac rhythm present upon ECG assessment by EMS personnel|||participants|||Number
1456034|NCT00808236|Primary|Survived Neurologically-Intact|"The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered neurologically intact.~- Good cerebral performance: little to no deficit.~- Moderate cerebral disability: capable of independent activities of daily life~- Severe cerebral disability: conscious, but dependent on others for daily support~- Coma or vegetative state~- Death or brain death"|30-days after arrest|The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn.|||participants|||Number
1456035|NCT00808236|Primary|Survived to Hospital Discharge|The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.|30 days after arrest|"The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn. One RhinoChill patient that achieved ROSC was found to be DNAR upon hospital arrival and was excluded from analyses thereafter. The final number of analyzed RhinoChill patients was therefore 82."|||participants|||Number
1456036|NCT00808236|Primary|Achieve Return of Spontaneous Circulation (ROSC)|ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.|1-hour after arrest|Only patients meeting all inclusion/exclusion criteria (IC/EC) were included in the analyses. 15 patients were found to not meet all IC/EC after enrollment. 2 more patients were lost to follow-up and 1 patient was crossed over (Control to RhinoChill) and then withdrawn. Informed consent nor data was obtained for any of these patients.|||participants|||Number
1456037|NCT00808132|Secondary|Percentage of Participants With Uterine Bleeding|Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.|Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure and “n” signifies participants who were evaluable at specified time points for each arm respectively.|||Percentage of Participants|||Number
1456038|NCT00808132|Secondary|Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline, Month 3|"MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N: maximum number of participants who were evaluable for this outcome and n: participants who were evaluable at specified time points for each arm."|||Units on a Scale||Standard Error|Least Squares Mean
1456039|NCT00808132|Secondary|Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study|MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.|||Units on a Scale||Standard Deviation|Mean
1456040|NCT00808132|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline, Month 3|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.|||Units on a Scale||Standard Error|Least Squares Mean
1456041|NCT00808132|Other Pre-specified|Percentage of Participants With Breast Tenderness|Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.|Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52|MITT population included all randomized participants who took 1 dose of study drug and had at least 20 days of data available at screening and at least 20 continuous days of data in at least one 4-week interval after baseline.|||Percentage of Participants|||Number
1456042|NCT00808132|Secondary|Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study|Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.|Baseline|MITT population included all randomized participants who met inclusion criteria for sleep sub-study and had baseline and at least 1 post-baseline evaluation for the respective endpoint. Here N = maximum number of participants who were evaluable for this outcome and n = participants who were evaluable at specified time points for each arm.|||Units on a Scale||Standard Deviation|Mean
1456054|NCT00808067|Secondary|Annualized Rate of Subjects With Minor Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456043|NCT00808132|Secondary|Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study|Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.|Baseline, Month 6, 12|"MITT for osteoporosis substudy. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at specified time points for each arm respectively."|||Percent Change||Inter-Quartile Range|Median
1456044|NCT00808132|Secondary|Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study|Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study|Baseline, Month 12|"Per-Protocol (PP) population included all randomized participants who met inclusion criteria for breast density sub-study, who had a baseline and at least 1 post-baseline breast density evaluation and did not have substantial protocol violations. Here N signifies participants who were evaluable for this outcome measure."|||Percent Change||Standard Error|Least Squares Mean
1456045|NCT00808132|Secondary|Percentage of Participants With Cumulative Amenorrhea: Main Study|Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.|Day 1 up to Day 364|MITT population included all randomized participants who received at least 1 dose of the study drug, and had at least 1 day of on-therapy bleeding data. Here “N” signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1456046|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study|BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6, Month 12|"MITT for osteoporosis sub-study. LOCF method was used to impute missing values. Here n signifies participants who were evaluable at specified time points for each arm, respectively."|||Percent Change||Standard Error|Least Squares Mean
1456047|NCT00808132|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 6|"MITT population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had baseline and at least 1 post baseline value. LOCF method was used to impute missing values. Here N signifies participants who were evaluable for this outcome measure."|||Percent Change||Standard Error|Least Squares Mean
1456048|NCT00808132|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study|BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.|Baseline, Month 12|Modified Intent-to-Treat (MITT) population included all randomized participants who met inclusion criteria for osteoporosis sub-study, who had taken at least 1 dose of the study drug, and had a baseline and at least 1 post baseline value. Last Observation Carried Forward (LOCF) method was used to impute missing values.|||Percent Change||Standard Error|Least Squares Mean
1456049|NCT00808132|Primary|Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study|Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.|Month 12|Efficacy evaluable (EE) population included all randomized participants who took at least 1 dose of study drug, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.|||Percentage of Participants||95% Confidence Interval|Number
1456050|NCT00808080|Secondary|If Phase I Has Successfully Shown the Target Dose to be Below the MTD Continue Enrolling Until 38 Patients Have Received the Target Dose. Patients Will be Monitored for Safety and Efficacy.||2.5 years estimated|||||||
1456051|NCT00808080|Primary|6 Dose Cohorts for Safety Monitoring. Each Cohort is Assessed for DLT for One Month After Autologous Cultured CTL Infusion Prior to Enrolling the Next Cohort.||2.5 years estimated|Not Applicable as none of the enrolled patients became eligible for infusion||||||
1456052|NCT00808067|Secondary|Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456053|NCT00808067|Secondary|Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456126|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html).|baseline||||Z-score||Standard Deviation|Mean
1456055|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456056|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456057|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456058|NCT00808067|Secondary|Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)|Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456059|NCT00808067|Secondary|Death, Annualized Rate of Subject Death|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456060|NCT00808067|Secondary|Deep Vein Thrombosis, Annualized Rate of Subjects With DVT|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Deep Vein Thrombosis (DVT) was generally documented by one of the following:~abnormal compression ultrasound (CUS),~an intraluminal filling defect on venography."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456061|NCT00808067|Secondary|Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456062|NCT00808067|Secondary|Pulmonary Embolism (PE), Annualized Rate of Subjects With PE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Pulmonary Embolism was generally documented by one of the following:~an intraluminal filling defect in segmental or more proximal branches on spiral CT scan~an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram~a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)~inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456063|NCT00808067|Secondary|Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy."|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456064|NCT00808067|Secondary|Stroke, Annualized Rate of Subjects With Stroke|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital"|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456065|NCT00808067|Primary|Major Bleeding, Annualized Rate of Subjects With Major Bleeds|"Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.~Major bleeding must have satisfied one or more of the following criteria:~Bleeding associated with a reduction in hemoglobin of at least 20 g/L~Required transfusion of at least 2 units of blood or packed cells~Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal~Major bleed were classified as life-threatening if they met one or more of the following criteria:~Reduction in hemoglobin of at least 50 g/L~Transfusion of at least 4 units of blood or packed cells~Symptomatic intracranial bleeding, either subdural or intracerebral~Associated with hypotension requiring use of intravenous inotropic agents~Required surgical intervention to stop bleeding~Resulted in death"|up to 43 months|SAF-FAS interval|||percentage of subject-years|||Number
1456066|NCT00808028|Other Pre-specified|Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B||Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Titer||95% Confidence Interval|Geometric Mean
1456067|NCT00808028|Secondary|Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level||1 month before vaccination 1, 1 month after vaccination 2, 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Percentage of participants|||Number
1456068|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 2||6 month after vaccination 3 up to 48 months|Safety population included participants who received at least 1 dose of study vaccine.|||Percentage of participants|||Number
1456069|NCT00808028|Primary|Percentage of Participants With Atleast One Adverse Event (AE): Stage 1||Vaccination 1 upto 1 Month after vaccination 3|Safety population included participants who received at least 1 dose of study vaccine.|||Percentage of participants|||Number
1456070|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3||Before vaccination 1 up to 1 month after vaccination 3|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Percentage of participants|||Number
1456071|NCT00808028|Primary|Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2||Before vaccination 1 up to 1 month after vaccination 2|mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|||Percentage of participants|||Number
1456072|NCT00808015|Other Pre-specified|Concomitant Drug Treatments||Baseline through Last observed study visit (Week 12 or ET)|FAS included all participants who received at least 1 dose of study medication.|||Participants|||Number
1456073|NCT00808015|Other Pre-specified|Median Duration of Treatment of Varenicline|The duration was defined as the total number of dosing days from first to last day of each study treatment.|Baseline through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis.|||Days||Full Range|Median
1456074|NCT00808015|Other Pre-specified|Average Daily Dose of Varenicline||Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||mg||Full Range|Median
1456075|NCT00808015|Other Pre-specified|Varenicline Prescription Status|Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'.|After last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication.|||participants|||Number
1456076|NCT00808015|Secondary|Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit|The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No).|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=518).|||cigarettes||Full Range|Median
1456077|NCT00808015|Secondary|CO Level at Last Observed Study Visit|The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site.|Last observed study visit (Week 12 or ET)|FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=115).|||ppm||Standard Deviation|Mean
1456078|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 3 through Week 11|At Week t (t = 3 to 11), the analysis population was “Observed Cases minus Week t” (OC minus Week t), that is (i-e), participants in FAS excluding missing values at the time point in question where OC was the subset of participants in FAS with observed (not missing) values.|||percentage of participants|||Number
1456079|NCT00808015|Secondary|Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Last observed study visit (Week 12 or early termination [ET])|FAS included all participants who received at least 1 dose of study medication.|||percentage of participants||95% Confidence Interval|Number
1456127|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|Baseline||||inches||Standard Deviation|Mean
1456128|NCT00807560|Secondary|Hip Measurement|Hip measurement in inches. This is not a primary outcome variable.|up to 44 weeks||||inches||Standard Deviation|Mean
1456080|NCT00808015|Primary|Percentage of Participants With Smoking Abstinence at Week 12|Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.|Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication|||percentage of participants||95% Confidence Interval|Number
1456081|NCT00807989|Secondary|Seizure Free Rate for 52 Weeks at Initial Target Dose||52 weeks||||participants|||Number
1456082|NCT00807989|Secondary|Seizure Free Rate for 24 Weeks at Initial Target Dose||24 weeks||||participants|||Number
1456083|NCT00807989|Primary|Retention Rate After 52 Weeks Maintenance Period|* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.|52 weeks||||participants|||Number
1456084|NCT00807937|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score|"Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.~Change : percentage at week 4 minus percentage at randomization"|Baseline to week 4||||percentage||Standard Error|Least Squares Mean
1456085|NCT00807937|Secondary|Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score|The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder.|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
1456086|NCT00807937|Secondary|Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score|"The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder.~Change: score at week 4 minus score at randomization"|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
1456087|NCT00807937|Secondary|Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score|HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
1456088|NCT00807937|Primary|Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization|Baseline to week 4||||Units on scale||Standard Error|Least Squares Mean
1456089|NCT00807885|Secondary|Time Required to Infuse 1000 mL Fluid||from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused|ITT (all treated subjects)|||hours||Standard Deviation|Mean
1456090|NCT00807885|Secondary|Time Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)|||seconds||Full Range|Median
1456091|NCT00807885|Secondary|Attempts Needed to Successfully Place Subcutaneous Catheter/Button||from start of first attempt until completion of catheter/button placement|ITT (all treated subjects)|||participants|||Number
1456092|NCT00807885|Primary|Technical Challenges|Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered|throughout subcutaneous hylenex and fluid administration period (continuous)|ITT (all treated subjects)|||participants|||Number
1456093|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).|||bpm||Standard Deviation|Mean
1456094|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)|A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).|||mmHg||Standard Deviation|Mean
1456095|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.|||bpm (beats per minute)||Standard Deviation|Mean
1456096|NCT00807846|Other Pre-specified|Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit|Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.|6 weeks/Final Visit|Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.|||mmHg||Standard Deviation|Mean
1456097|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.|Week 6/Final Visit|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.|||Participants|||Number
1456098|NCT00807846|Secondary|Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.|Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor’.|6 weeks|MITT population was used. Additional 3 participants aged <8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (>=8 yrs) not provided self-assessment and 2 (>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (<8 yrs) provided self-assessment and included in analysis.|||mm||Standard Error|Least Squares Mean
1456099|NCT00807846|Secondary|Number of Participants With >= 30% Improvement in the Parent’s Global Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.|Week 6/Final Visit|The MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.|||Participants|||Number
1456100|NCT00807846|Secondary|Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.|The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being ‘very well’ and 100 being ‘very poor.|6 weeks|Modified-Intent-to-Treat (MITT) Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.|||mm (millimeter)||Standard Error|Least Squares Mean
1456101|NCT00807846|Secondary|Change From Baseline in DBP at Week 6/Final Visit|Value at 6 weeks/Final Visit minus value at baseline.|6 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
1456102|NCT00807846|Secondary|Change From Baseline in DBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
1456103|NCT00807846|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
1456104|NCT00807846|Secondary|Change From Baseline in SBP at Week 4.|Value at 4 weeks minus value at baseline.|4 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
1456105|NCT00807846|Secondary|Change From Baseline to Week 2 in SBP.|Value at 2 weeks minus value at baseline.|2 weeks|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data."|||mmHg||Standard Error|Least Squares Mean
1456106|NCT00807846|Primary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit|Value at 6 weeks minus value at baseline.|6 Weeks/Final Visit|"Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP (blood pressure) measurements.~For early terminations the last observation carried forward (LOCF) was used to impute missing data."|||mmHg (millimeter of mercury)||Standard Error|Least Squares Mean
1456107|NCT00807768|Other Pre-specified|Gene Expression Based Risk Score||Baseline|||||||
1456108|NCT00807768|Secondary|Patient-reported Quality of Life|Patient reported quality of life as measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-En TOI). The FACT-En TOI is a scale for assessing general QOL of endometrial cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Endometrium Cancer subscale (16 items). Each item in the FACT-En TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). . The FACT-En TOI score is calculated as the sum of the subscale scores if more than 80% of the FACT-En TOI items provide valid answers and all of the component subscales have valid scores. The FACT-En TOI score ranges 0-120 with a large score suggests better QOL|Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment|Provided baseline and >= follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
1456109|NCT00807768|Secondary|Patient-reported Neurotoxicity|Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggesting less neurotoxicity.|Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment.|Provided baseline and ≥ follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
1456110|NCT00807768|Secondary|Patient Reported Fatigue|Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggests less fatigue.|Prior to study treatment (baseline), 4 weeks post the starting of study treatment, 10-11 weeks post the starting of study treatment, 8 months post the starting of study treatment, 14 months post the starting of study treatment|Provided baseline and >= follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
1456111|NCT00807768|Secondary|Number of Participants With Sites of Recurrence|Three competing risk analyses were carried out for three different types of recurrences: 1) any vaginal, 2) any pelvic or any PA nodes and 3) any distant. More than one type of recurrence can be counted for an individual patient. A death prior to a specific type of recurrence was considered a competing event.|Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated thereafter, up to 10 years|All enrolled patients|||Participants|||Count of Participants
1456112|NCT00807768|Secondary|Number of Participants With Death Events|The number of death events is reported. Overall survival is reported by the number of deaths occurring while on study.|Overall survival is measured from study enrollment for up to 10 years.|All enrolled patients.|||Participants|||Count of Participants
1456113|NCT00807768|Primary|Number of Participants With Recurrence or Death Events at Primary Analysis|Recurrence-Free Survival is the period from study entry until disease recurrence, death, or date of last contact|Within 4 weeks after completing or discontinuing study therapy, then every 6 months for 2 years, then annually for 3 years, then as clinically indicated, assessed up to 10 years|All enrolled patients|||Participants|||Count of Participants
1456114|NCT00807664|Secondary|Total Number of Adverse Events||Day 0 to Day 70||||Adverse Event|||Number
1456115|NCT00807664|Secondary|Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline|"The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation:~Area= Lenght *Width * pi [3.142] / 4~All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used."|Day 0 to Day 70|ITT (ANCOVA) - LOCF was applied for subjects not having a value at visit 3 but a value at visit 2 for the ulcer area|||Percentage change||95% Confidence Interval|Mean
1456116|NCT00807664|Primary|Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline|"The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation:~Area= Lenght *Width * pi [3.142] / 4~All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used."|Day 0 to Day 42|A total of 182 subjects were randomised in the study (safety analysis set), however one patient was in systemic antibiotic treatment and was erroneously enrolled, hence the ITT analysis set comprised 181 subjects.|||Percentage change||Standard Deviation|Mean
1456117|NCT00807573|Primary|Objective Response Rate (CR + PR by RECIST) Paclitaxel, Pemetrexed, and Bevacizumab in Patients With Advanced Non-Small Lung Cancer Who Have Received no Prior Treatment for Metastatic Disease.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years||||participants|||Number
1456118|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|up to 44 weeks||||percentile||Standard Deviation|Mean
1456119|NCT00807560|Primary|BMI Z Score|Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator (https://www.bcm.edu/research/centers/childrens-nutrition-research-center/bodycomp/bmiz2.html)|up to 44 weeks||||Z-score||Standard Deviation|Mean
1456120|NCT00807560|Secondary|BMI Percentile|Body Mass Index percentile. This is not a primary outcome variable.|baseline||||percentile||Standard Deviation|Mean
1456121|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the primary outcome variable of BMI z-score.|up to 44 weeks||||kg/m^2||Standard Deviation|Mean
1456122|NCT00807560|Secondary|BMI|Body Mass Index: this variable informs the calculation of the outcome variable of BMI z-score.|baseline||||kg/m^2||Standard Deviation|Mean
1456123|NCT00807560|Secondary|Weight|This variable informs the calculation of the outcome variable of BMI z score.|up to 44 weeks||||pounds||Standard Deviation|Mean
1456124|NCT00807560|Secondary|Weight|This variable informs the calculation for the outcome variable of BMI Z score.|baseline||||pounds||Standard Deviation|Mean
1456125|NCT00807560|Secondary|Height|This variable informs the calculation of the outcome variable of BMI Z score.|up to 44 weeks||||inches||Standard Deviation|Mean
1456133|NCT00807495|Secondary|Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events|Abnormal laboratory values for chemistry or hematology tests that were assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4). A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 25 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
1456134|NCT00807495|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events|Vital signs (blood pressure, heart rate, and oral temperature) measurements were obtained throughout the study. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose (Up to 25 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
1456135|NCT00807495|Secondary|Number of Participants With Treatment-Emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and includes all-causality (ie, treatment-related and not treatment-related as assessed by the investigator).|First dose of study drug to 30 days after last dose (Up to 25 months)|Safety population was defined as all participants who received any amount of alisertib.|||participants|||Number
1456136|NCT00807495|Secondary|Duration of Response (DOR)|DOR is defined as the time from the date of first documentation of a CR, or partial response (PR) to the date of first documentation of PD according to IWG criteria. CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria (Cheson 2007).|Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)|Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. All responders were evaluated in this outcome measure. Participants who had not progressed, DOR was censored at last response assessment that was SD or better.|||days||95% Confidence Interval|Median
1456137|NCT00807495|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death.|Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)|Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. For a participant who had not progressed and had not died, PFS was censored at the last response assessment that was SD or better.|||days||95% Confidence Interval|Median
1456138|NCT00807495|Secondary|Time to Progression (TTP)|Time to progression (TTP) is defined as the time in days from the date of first study drug administration to the date of first documentation of Progressive Disease (PD) according to IWG criteria (Cheson 2007). PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Baseline and every 2 cycles up to Month 12, from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Up to 4 years)|Response-evaluable population is subset of safety population, defined as all participants who received any amount of alisertib, having minimum of baseline imaging and one on-study imaging. Here number of participants analyzed were participants with PD. TTP was censored at the last response assessment that was SD or better.|||days||95% Confidence Interval|Median
1456139|NCT00807495|Primary|Best Overall Response Rate Based on Investigator’s Assessment (Applying the IWG 2007 Response Criteria)|Best overall response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites (as specified in the Cheson 2007, IWG response criteria).|Baseline and every 2 cycles up to Month 12 (approximately 16 cycles), from Cycle 16 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months from last dose (Up to 4 years)|Safety population was defined as all participants who received any amount of alisertib. Efficacy analysis for the response-evaluable population is a subset of the safety population, with participants having a minimum of baseline imaging and one on-study imaging.|||percentage of participants|||Number
1456140|NCT00807456|Primary|Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to 16 Weeks After Implant Placement|Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant (the rim (R), i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.|At baseline and 16 weeks||||millimeter|Participants|Standard Deviation|Mean
1456141|NCT00807365|Primary|Change in Lean Body Mas||2 years|Study terminated prior to collection of data||||||
1456142|NCT00807248|Secondary|Clinical Global Impression - Global Improvement (CGI-I)|The CGI-I provides the clinician’s impression of the patient’s improvement (or worsening). The clinician assesses the patient’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|at Week 8|At Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
1456143|NCT00807248|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
1456144|NCT00807248|Secondary|SDS: Social Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
1456145|NCT00807248|Secondary|SDS: Work Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
1456146|NCT00807248|Secondary|Sheehan Disability Scale (SDS): Family Subscale|The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
1456147|NCT00807248|Secondary|Insomnia Severity Index (ISI)|The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient’s perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
1456148|NCT00807248|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42.|Mean change from baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Mean
1456149|NCT00807248|Secondary|MADRS|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|From baseline to Week 8|Mean change from baseline to Week 8 (FAS, LOCF, ANCOVA)|||Scores on a scale||Standard Error|Least Squares Mean
1456150|NCT00807248|Primary|Montgomery and Åsberg Depression Rating Scale (MADRS)|The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60.|Baseline to 8 weeks|Mean change from baseline to Week 8: Full-analysis Set (FAS), Last Observation Carried Forward (LOCF), Analysis of Covariance (ANCOVA)|||Scores on a scale||Standard Error|Mean
1456151|NCT00807235|Secondary|Number of Participants With Air Leak||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456152|NCT00807235|Secondary|Incidence of Mortality||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456153|NCT00807235|Secondary|Number of Participants With Acquired Sepsis||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456154|NCT00807235|Secondary|Number of Participants With Pulmonary Hemorrhage||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456155|NCT00807235|Secondary|Number of Participants With Necrotizing Enterocolitis (NEC)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456156|NCT00807235|Secondary|Number of Participants With Patent Ductus Arteriosus (PDA)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456157|NCT00807235|Secondary|Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456158|NCT00807235|Secondary|Number of Participants Alive and Without BPD||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456159|NCT00807235|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)||28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456160|NCT00807235|Secondary|Time to Meet Failure Criteria|Failure criteria defined as rescue with bolus surfactant and mechanical ventilation|Through 28 days|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat). Time in days calculated for neonates who met failure criteria (3 for Regimen 1, 2 for Regimen 2)"|||days||Standard Deviation|Mean
1456173|NCT00807092|Secondary|Change in Mean FBG Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and at end of treatment (week 6). Change in mean FBG from baseline (week 0) was assessed. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 0, week 6||||mmol/L||Standard Error|Least Squares Mean
1457373|NCT00796744|Primary|The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.||Healing to occur within 12 weeks of first treatment|Intent-to-Treat Population|||number of ulcers healed|||Number
1456161|NCT00807235|Secondary|Arterial Alveolar (a/A) O₂Ratio|a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.|72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||mm Hg over mm Hg (ratio of pressures)||Standard Deviation|Mean
1456162|NCT00807235|Secondary|Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)|AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward|0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||percent O₂*hours||Standard Deviation|Mean
1456163|NCT00807235|Primary|Number of Participants With Respiratory Distress Syndrome||24 hours|"This was a phase 2, pilot, estimation study. Hence, sample size calculations were not performed.~All enrolled infants analyzed (intent-to-treat)."|||participants|||Number
1456164|NCT00807209|Primary|Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.|The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.|72 hours||||micrograms|||Number
1456165|NCT00807092|Secondary|Hypoglycaemia Based on Self-reported Episodes|Total number of hypoglycaemic episodes occurring in the trial after baseline (week 0) until the end of treatment (week 6). Hypoglycaemic episodes are classified as major, minor or symptoms only: Major if the subject was unable to treat her/himself; minor if subject was able to treat her/himself and self monitored blood glucose (SMBG) was below 2.8 mmol/L; symptoms only if subject was able to treat her/himself and with no blood glucose measurement or SMBG higher than or equal to 2.8 mmol/L.|Weeks 0-6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).|||episodes|||Number
1456166|NCT00807092|Secondary|Duration of Hypoglycaemic Events Based on CGMS|The CGMS device recorded blood glucose levels every 10 seconds then stored a smoothed average over 5 minutes. The range of blood glucose detection was 2.2-22 mmol/l. Hypoglycaemia was defined as blood glucose readings below 3.5 mmol/l or below 2.5 mmol/l, respectively. The duration of the hypoglycaemic episodes was quantified by accumulating the total time the CGMS profiles stays below the defined threshold (i.e. below 3.5 mmol/l or below 2.5 mmol/l, respectively).|72-hour monitoring period at Week 0 and Week 6|Safety analysis set consists of all randomised subjects who were exposed to at least one dose of trial product(s).|||Hours||Standard Error|Least Squares Mean
1456167|NCT00807092|Secondary|Change in Glycosylated Haemoglobin (HbA1c)||Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||percentage point change||Standard Error|Least Squares Mean
1456168|NCT00807092|Secondary|Change in GA (Glycated Albumin)|Glycated Albumin is used as a general glycaemic control parameter. Analysed by laboratory. GA was measured at baseline (week 0) and end of treatment (week 6). Change in GA at end of treatment (week 6) from baseline (week 0) was assessed.|Week -2, week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||percentage point change||Standard Error|Least Squares Mean
1456169|NCT00807092|Secondary|Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS|MAGE is a parameter to monitor the intraday blood glucose excursions. It was calculated using CGMS data and as the arithmetic mean of glycaemic excursion with the criterion that both segments (ascending and descending parts) of the glycaemic excursion exceed of the value of one standard deviation of respective 24-hour blood glucose value. The direction of calculation (peak-to-nadir or nadir-to-peak) was established by the direction of the first excursion. The arithmetic mean of the glycaemic excursion of day 1 and day 2 was the value of MAGE for each CGMS|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
1456170|NCT00807092|Secondary|Change in Prandial Blood Glucose Increment|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6 respectively. Prandial increment was the difference between the blood glucose (BG) value measured 120 minutes after meal and the BG value measured before meal.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
1456171|NCT00807092|Secondary|Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles|Subjects were asked to perform 8-point SMBG profiles using the provided blood glucose meter on one day within 72 hours CGMS monitoring period at week 0 and week 6. Change in blood glucose level at end of treatment (week 6) from baseline (week 0) at each time point was to be assessed respectively. Blood glucose levels were measured at the following 8 time points: Before each meal (breakfast, lunch and dinner), 120 minutes after the start of each meal, at bedtime and at 3 am in the morning.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products|||mmol/L||Standard Error|Least Squares Mean
1456172|NCT00807092|Secondary|Change in FPG (Fasting Plasma Glucose)|FPG was analysed by local laboratories at baseline (week 0) and end of treatment (week 6). Change in FPG at end of treatment (week 6) from baseline (week 0) was to be assessed.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) (if a measurement on the withdrawal visit was available) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
1456174|NCT00807092|Secondary|Mean FBG (Fasting Blood Glucose) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at end of treatment (week 6). Mean FBG assessed by CGMS at 6 weeks. FBG was read on the CGMS glucose curves at 06:00 each morning over the 72 hours. The arithmetic mean of day 1 and day 2 was used as the value of mean FBG for each CGMS period.|Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
1456175|NCT00807092|Secondary|Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS|The blood glucose profiles were monitored by CGMS for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC (0-4 hours) after each meal at 6 weeks and change in IAUC (0-4 hours) from baseline (week 0) after each meal were to be assessed. The arithmetic mean of day 1 and day 2 for each meal-specific incremental area (breakfast, lunch, dinner) was calculated.|Week 0, Week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
1456176|NCT00807092|Primary|Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals|The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period|Week 0, week 6|The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|||mmol/L||Standard Error|Least Squares Mean
1456177|NCT00807040|Secondary|All-cause Mortality||Measured at Month 24||||Participants|||Count of Participants
1456178|NCT00807040|Primary|Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)||Measured at Month 12||||ml per square meter of body-surface area||Standard Deviation|Mean
1456179|NCT00807014|Secondary|Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination|Participants were evaluated for overall tolerance to study drug by the investigator at the end of the study (Week 12 or Early Termination). Participants were given the tolerance grades of poor, fair, good, or excellent.|Week 12 or Early Termination|ITT Population. Some participants had no data available and were thus excluded from analysis.|||participants|||Number
1456180|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning|Tolerance symptoms of itching and burning were evaluated at each visit by participants. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).|||scores on a scale||Standard Deviation|Mean
1456181|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness|Tolerance symptoms of peeling (flaking), erythema (redness of skin), and dryness were evaluated at each visit by the investigator. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).|||scores on a scale||Standard Deviation|Mean
1456182|NCT00807014|Secondary|Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System|The acne grade on the participant’s face was assessed by the investigator using the LRAG, a photographic scale allowing for the assessment of the clinical status for acne severity for the face, back, and chest. It consists of a 12-grade scale (1, least severe; 12, most severe) for inflammatory visible lesions (les.). For non-inflammatory les., this scale comprises 3 photos of les. of increasing severity (grades 1-3). The scale provides a qualitative assessment of superficial/visible les. and provides consistency and inter-/intra-rater reliability. Grading was performed prior to les. counting.|Baseline (Week 0); Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.|||scores on a scale||Standard Deviation|Mean
1456183|NCT00807014|Secondary|Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1456184|NCT00807014|Secondary|Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)|Global change in acne improvement was assessed by the investigator on a 7-point scale: 1=greatly worsened, 2=significantly worsened, 3=slightly worsened, 4=no change, 5=slightly improved, 6=significantly improved, or 7=greatly improved. Global change at the indicated week was assessed in terms of change from the previous week. Change at Week 2, for example, was an assessment of change from Week 1.|Start of treatment and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
1456185|NCT00807014|Secondary|Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2|Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman’s correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation.|Baseline (Week 0) and Week 2|ITT Population. Missing values were imputed using the LOCF method. One participant in the Differin group had no data available and was thus excluded from analysis.|||Correlation coefficient|||Number
1456324|NCT00805935|Secondary|Human Chorionic Gonadotropin (hCG) Levels at Day 6|Blood tests were sent to a central laboratory to obtain hCG levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||mIU/ml||Standard Deviation|Mean
1456186|NCT00807014|Secondary|Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions (IL) included papules, pustules, nodules, and cysts. Non-inflammatory lesions (NIL) included closed comedones (whiteheads) and open comedones (blackheads). Total lesion count was calculated as the sum of IL and NIL. Percent change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline divided by Baseline value * 100.|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method. Some participants had no baseline lesions of an individual type; percent change from baseline is undefined for these participants. All participants, however, had at least one type of lesion; thus, all participants in the ITT Population were analyzed for total lesion count.|||percent change in lesions||Standard Deviation|Mean
1456187|NCT00807014|Secondary|Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts|Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions included papules, pustules, nodules, and cysts. Non-inflammatory lesions included closed comedones (whiteheads) and open comedones (blackheads). The total lesion count was calculated as the sum of inflammatory and non-inflammatory lesions. Change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline (Week 0).|Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12|ITT Population. Missing values were imputed using the LOCF method.|||lesions||Standard Deviation|Mean
1456188|NCT00807014|Secondary|Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 12|ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). One participant in the Differin arm had no QoL data available and was thus excluded from analysis.|||scores on a scale||Standard Deviation|Mean
1456189|NCT00807014|Primary|Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 2|Intent-to-Treat (ITT) Population: all randomized participants (par.) who applied >= 1 dose of study product. Missing values were imputed using the last observation carried forward (LOCF, i.e., the last available observation was used to estimate subsequent missing data points) method. 1 par. in the Differin arm had no QoL data and was not analyzed.|||scores on a scale||Standard Deviation|Mean
1456190|NCT00807001|Secondary|Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)|Measures how much virus is in the blood.|Baseline to 4 days|efficacy evaluable population = a) must have received all 3 doses of study drug b) must have baseline and at least one post-baseline HCV RNA determination|||log10 IU/mL||Standard Deviation|Mean
1456191|NCT00807001|Primary|Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events|Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening|17 days|Safety population consisted of all subjects who received at least one dose of study drug.|||participants|||Number
1456192|NCT00806988|Secondary|Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention||Measured at Month 24||||Participants|||Count of Participants
1456193|NCT00806988|Primary|Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)||Measured at Month 12||||ml per square meter||Standard Deviation|Mean
1456194|NCT00806819|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 36 months|Treated set uncut - all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.|||% of participants|||Number
1456195|NCT00806819|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1456325|NCT00805935|Secondary|Estradiol Levels at Day 6|Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.|Day 6|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||pg/mL||Standard Deviation|Mean
1456196|NCT00806819|Secondary|Quality of Life (QoL)|"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
1456197|NCT00806819|Secondary|Clinical Improvement.|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
1456198|NCT00806819|Secondary|Change From Baseline in Tumour Size|Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||percentage of change in tumor size in mm||95% Confidence Interval|Mean
1456199|NCT00806819|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
1456200|NCT00806819|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||% of participants|||Number
1456201|NCT00806819|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
1456202|NCT00806819|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
1456203|NCT00806819|Secondary|Objective Tumor Response|Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator|From randomisation until data cut-off (15 February 2013), Up to 30 months|Randomised Set|||% of participants|||Number
1456204|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
1456205|NCT00806819|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||Months||Inter-Quartile Range|Median
1456206|NCT00806819|Secondary|Overall Survival (Key Secondary Endpoint)|Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.|From randomisation until data cut-off (15 February 2013), Up to 30 months|RS|||months||Inter-Quartile Range|Median
1456207|NCT00806819|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 9 July 2012|RS|||months||Inter-Quartile Range|Median
1456208|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7||||percentage of participants||95% Confidence Interval|Number
1456209|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age With a Kidney Transplant Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
1456210|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
1456211|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age on Dialysis Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
1456212|NCT00806676|Primary|Percentage of Patients 16-21 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2||Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
1456213|NCT00806676|Primary|Percentage of Patients 9-15 Years of Age With CKD Achieving Seropositivity (IgG Assay) at Blood Draw 2|The primary outcome was antibody response to each of four HPV genotypes contained within the HPV vaccine at the time periods specified for the blood draws. Antibody levels, measured by Merck GmbH, were initially determined using the competitive Luminex immunoassay(cLIA; Merck GmbH), the assay used in the original licensing studies. Seropositivity was defined as being above thresholds set at 20, 16, 20, and 24 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively, as determined in phase 2 studies among patients who were immunocompetent. Antibody levels were reanalyzed using the newer, more sensitive IgG cLIA in stored serum from blood draws 2 and 3. Seropositivity for this assay was defined as being above thresholds set at 15, 15, 7, and 10 milliMerck units for HPV genotypes 6, 11, 16, and 18, respectively.|Month 7|Some patients did not complete all 3 blood draws because of (1) previous vaccination at primary care physician’s office, which precluded blood draws 1 and/or 2; (2) inconsistent clinic visits, which precluded the 2nd or 3rd blood draw; and/or (3) administrative censoring in July 2012.|||percentage of participants||95% Confidence Interval|Number
1456214|NCT00806624|Secondary|Evaluation of All Clinical and Laboratory Safety Data.||6 months|||||||
1456215|NCT00806624|Secondary|Evaluation of Effects on Pharmacodynamic Biomarkers||6 months|||||||
1456216|NCT00806624|Secondary|Evaluation of Plasma Concentration of DU-176||6 months|||||||
1456217|NCT00806624|Secondary|Evaluation of Effects on Biomarkers of Thrombus Formation||6 months|||||||
1456218|NCT00806624|Secondary|Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition||6 months|||||||
1456219|NCT00806624|Primary|Incidence of All Bleeding|Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF.|6 months|The Safety Analysis Set was defined as all subjects who received at least one dose of study drug and had at least one post-dose safety assessment. The primary endpoint were analyzed for the subjects who proceeded to the treatment period in the Safety Analysis Set.|||percentage of subjects with bleeds||95% Confidence Interval|Number
1456220|NCT00806598|Primary|Overall Response|Complete response (CR) was defined as normalization of peripheral blood and bone marrow with <5% blasts, a peripheral absolute neutrophil count (ANC) >/= 1 * 10^9/l, hemoglobin >/= 100g/l, and a platelet count >/= * 10^9/l, Partial Response (PR) was defined as transfusion independence with a peripheral blood ANC >=/ 0.05 * 10^9/l, a platelet count >/= 20 * 10^9/l, and a hemoglobin >/= 40 g/l. Hematologic improvement was defined as a clinically relevant increase in hemoglobin, platelets or absolute neutrophil count.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Assessed first at 3 months on study, continuing monthly up to 3 years.|Of the 48 participants who received treatment 46 were evaluable for response.|||participants|||Number
1456221|NCT00806585|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and did not lack of any endpoint data (both baseline and post-randomization)|||Percentage Change||Standard Error|Least Squares Mean
1456222|NCT00806585|Secondary|Change From Baseline in Body Weight at Week 24|Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.|Baseline and Week 24|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||kg||Standard Error|Least Squares Mean
1456223|NCT00806585|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||Percentage Change||Standard Error|Least Squares Mean
1456224|NCT00806585|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||mmHg||Standard Error|Least Squares Mean
1456326|NCT00805935|Secondary|Percentage of Participants With Ongoing Pregnancy at Week 9|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 65|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
1456225|NCT00806585|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.|Baseline and Week 12|Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)|||mmHg||Standard Error|Least Squares Mean
1456226|NCT00806546|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch application|Per protocol, all subjects who applied at least one NP101 study patch were included in the safety population.|||scores on a scale|Participants|Standard Deviation|Mean
1456227|NCT00806494|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.|Baseline, Week 12|FAS. n=number of participants with analyzable data.|||Score on Scale||95% Confidence Interval|Mean
1456228|NCT00806494|Secondary|Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12|TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to ‘Satisfied’ (including ‘very satisfied’ and ‘somewhat satisfied’) and ‘Dissatisfied’ (including ‘very dissatisfied’,‘somewhat dissatisfied’, and ‘neither dissatisfied nor satisfied’). Percentage of participants reporting satisfaction included those with categorical responses of ‘very satisfied’ and ‘somewhat satisfied’.|Week 12 (or Early Withdrawal)|FAS. N=number of participants with analyzable data.|||Percentage of Participants|||Number
1456229|NCT00806494|Secondary|Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire|BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).|Week 12 (or Early Withdrawal)|FAS, LOCF.|||Participants|||Number
1456230|NCT00806494|Secondary|Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12|ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.|Baseline, Week 12|FAS. N=number of participants with analyzable data.|||Score on Scale||95% Confidence Interval|Mean
1456231|NCT00806494|Secondary|Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12|OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.|Baseline, Week 4 and Week 12|FAS. N=number of participants with baseline score. n=number of participants analyzed at specified timepoint. Missing data at Week 12 imputed using LOCF approach.|||Score on Scale||95% Confidence Interval|Mean
1456232|NCT00806494|Secondary|Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12|UPS: self-administered, single-item questionnaire to measure participant’s perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Participants|||Number
1456233|NCT00806494|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12|PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.|Baseline, Week 4 and Week 12|FAS; n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Participants|||Number
1456234|NCT00806494|Secondary|Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12|The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Incontinence Pads||95% Confidence Interval|Mean
1456235|NCT00806494|Secondary|Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
1456236|NCT00806494|Secondary|Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12|SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with SUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
1456237|NCT00806494|Secondary|Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
1456238|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12|"NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).~Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with NUEs >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
1456239|NCT00806494|Secondary|Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with urgency episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
1456240|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12|Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with urgency episodes >=3 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
1456241|NCT00806494|Secondary|Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
1456242|NCT00806494|Secondary|Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12|"UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).~Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement."|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (number of participants with UUI episodes >0 per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of Episodes||95% Confidence Interval|Mean
1456243|NCT00806494|Secondary|Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
1456327|NCT00805935|Secondary|Percentage of Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately Day 52|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
1456244|NCT00806494|Secondary|Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12|Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.|Baseline, Week 4 and Week 12|FAS; participants reporting this symptom at baseline (participants with nocturnal >0 micturitions per 24 hours during the 3-day baseline diary period). n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Number of episodes||95% Confidence Interval|Mean
1456245|NCT00806494|Secondary|Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12|Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.|Baseline, Week 4 and Week 12|FAS. n=number of participants analyzed at specified timepoint. Missing data at Week 12 were imputed using LOCF approach.|||Percentage Change||95% Confidence Interval|Mean
1456246|NCT00806494|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 4|FAS. N=number of participants with analyzable data.|||Number of Episodes||95% Confidence Interval|Mean
1456247|NCT00806494|Primary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12|The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.|Baseline, Week 12|Full analysis set (FAS)=participants who took at least one dose of study drug and provided baseline and post-baseline data for at least 1 efficacy endpoint. N=number of participants with analyzable data. Missing data at Week 12 were imputed using last (valid post-baseline) observation carried forward (LOCF) approach.|||Number of Episodes||95% Confidence Interval|Mean
1456248|NCT00806442|Secondary|Urinary Leukotriene Levels|Urinary leukotriene levels in plant seed oil vs. placebo|6 weeks|one participant was missing some urinary leukotriene data|||ng/ml||95% Confidence Interval|Mean
1456249|NCT00806442|Secondary|Night-time Wakenings|Average number of night-time wakenings in plant seed oil vs. placebo|6 weeks|one participant is missing some night-time wakening data|||average number of night-time wakenings||95% Confidence Interval|Mean
1456250|NCT00806442|Secondary|Day-time Symptoms of Bronchial Asthma|"Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms~= Mild: Symptom did not interfere with normal daily activity or sleep~= Moderate: Symptom was sufficient to interfere with normal daily activity or sleep~= Severe: Symptom was so severe as to prevent normal daily activity or sleep~These numbers were used for 1. Shortness of breath 2. Chest tightness 3. Wheezing 4. Cough 5. Phlegm/Mucus.~The total score is the sum of the 5 item scores, for a range of 0-15. A higher score represents more severe symptoms. Each participant's score is the average of varying numbers of diary cards. The treatment phase visits at 6 weeks consisted of 3 weeks of diary cards with a +/- 5 day window. The baseline visits had 2 weeks of diary cards with a +/- 5 day window. The treatment phase measures are adjusted for the baseline measures."|6 weeks||||units on a scale||95% Confidence Interval|Mean
1456251|NCT00806442|Secondary|Frequency of Rescue Use of Short Acting Beta-2 Agonists|Average number of puffs of albuterol daily in plant seed oil vs. placebo|6 weeks|one participant is missing some data on this measure|||Avg number of puffs of albuterol daily||95% Confidence Interval|Mean
1456252|NCT00806442|Secondary|Peak Flow Rate (PEFR)|Morning Peak Flow Rate in plant seed oil vs. placebo|6 weeks||||liters/minute||95% Confidence Interval|Mean
1456253|NCT00806442|Secondary|Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes|Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm|6 weeks on each treatment assignment|Patients who are C allele carriers or A homozygotes|||Participants|||Count of Participants
1456254|NCT00806442|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo|6 weeks|Includes participants that completed the study.|||liters||95% Confidence Interval|Mean
1456255|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).||||ng/mL||Standard Deviation|Least Squares Mean
1456256|NCT00806416|Primary|Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet|"Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet.~Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose."|On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).|Twenty-eight (28) subjects (excluding 2 that were enrolled but did not complete both study periods) were included in the statistical analysis.|||ng*hr/mL||Standard Deviation|Least Squares Mean
1456328|NCT00805935|Secondary|Percentage of Participants With Biochemical Pregnancy at Approximately Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
1456257|NCT00806416|Primary|Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet|Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.|On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).|Two hundred-seven (207) subjects (excluding 7 that were enrolled but did not complete both study periods) were included in the statistical analysis.|||micrograms (μg)||Standard Deviation|Least Squares Mean
1456258|NCT00806403|Secondary|Stroke||30 days|Analysis made on intention to treat (ITT) basis.|||Participants|||Number
1456259|NCT00806403|Secondary|Reinfarction||30 days|Analysis made on intention to treat (ITT) basis.|||Participants|||Number
1456260|NCT00806403|Primary|Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3|Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related artery 5-7 days after inclusion.|5-7 days after inclusion|Patient were analyzed on intention to treat (ITT) basis. The per protocol angiography on day 5-7 after inclusion was used for analysis of Thrombolysis In Myocardial Infarction (TIMI) flow grade in the infarct related coronary artery.|||participants|||Number
1456261|NCT00806403|Secondary|Death||30 days|Analysis was made on intention to treat (ITT) basis.|||participants|||Number
1456262|NCT00806403|Primary|Number of Patients With ST-segment Elevation Resolution Equal or More Than 50%|ST-segment elevation resolution was measured in the lead with most prominent ST elevation at time of inclusion|120 minutes after inclusion|Analysis was made on intention to treat(ITT) basis.Patients with electrocardiograms (ECGs) suitable for analysis at inclusion and at 120 minutes therafter were included in the analysis.|||participants|||Number
1456263|NCT00806390|Primary|Ejection Fraction by MUGA|Because of the inability to enroll an adequate number of patients, (only 15 out of a planned 50) no data analysis was collected or performed.|Pre and post anthracycline treatment|||||||
1456264|NCT00806351|Secondary|All-Cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up|Baseline up to 6 weeks post treatment|Safety Population|||participants|||Number
1456265|NCT00806351|Secondary|Time to Death|Time to death defined as: date of death minus first treatment date plus 1.|Day 1 up to Day 98|Safety Population;subset of participants who died|||days||Full Range|Median
1456266|NCT00806351|Secondary|Time to First Negative Blood Culture for Candida Species|A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.|Baseline up to Day 56|MITT Population; subset of participants who had a positive blood culture for Candida sp. on Day 1 of treatment. No participant in the Caspofungin treatment arm had a positive blood culture for Candida sp. on Day 1 of treatment.|||days||Full Range|Median
1456267|NCT00806351|Secondary|Number of Participants With New Infections|Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.|2 and 6 weeks post treatment|MITT Population|||participants|||Number
1456268|NCT00806351|Secondary|Number of Participants With Recurrence|Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.|2 and 6 weeks post treatment|MITT Population|||participants|||Number
1456269|NCT00806351|Secondary|Clinical Response at Day 10|Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.|Day 10|MITT Population; Number of participants analyzed (N): participants with evaluable data|||participants|||Number
1456270|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|6 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point|||participants|||Number
1456271|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|2 weeks post treatment|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point|||participants|||Number
1456272|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 14 up to Day 56|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOT was carried forward programmatically to all subsequent visits.|||participants|||Number
1456329|NCT00805935|Secondary|Number of Embryos Frozen|The number of embryos that were not transferred but instead were frozen for future use.|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Embryos||Standard Deviation|Mean
1456273|NCT00806351|Secondary|Response Based on Clinical Cure and Microbiological Success at EOIVT|Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication [f/u culture negative] or presumed eradication [f/u culture not available and a clinical response of cure]).|Day 10 up to Day 42|MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOIVT was carried forward programmatically to all subsequent visits.|||participants|||Number
1456274|NCT00806351|Secondary|Global Response at 6-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|6 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.|||participants|||Number
1456275|NCT00806351|Secondary|Global Response at 2-Week Follow-Up Visit|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|2 weeks post treatment|MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.|||participants|||Number
1456276|NCT00806351|Secondary|Global Response at End of Treatment (EOT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 14 up to Day 56|MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits.|||participants|||Number
1456277|NCT00806351|Primary|Global Response at End of Intravenous Treatment (EOIVT)|Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms [s/s] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up [f/u] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to [≥3] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species [sp]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).|Day 10 up to Day 42|Modified Intent to Treat (MITT) Population: participants who received at least 1 dose of study medication and had positive culture for Candida sp isolated from cultures obtained from a normally sterile site within 96 hours prior to treatment initiation. A global response of failure at EOIVT was carried forward programmatically to subsequent visits.|||participants|||Number
1456278|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:~(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent’s proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.~The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|Hour 2 and Hour 6|Intent-to-treat (ITT) ITT population includes participants who completed Periods 1, 2 and 3. Subjects that were discontinued due to adverse events, failed drug/alcohol screens, non-compliance, etc. are not included in this analysis.|||scores on a scale||Standard Error|Least Squares Mean
1456345|NCT00805766|Secondary|Serum Concentration of TA-650 at Each Time Point||Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks|Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||μg/mL||Full Range|Median
1456279|NCT00806260|Primary|Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.|"CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are:~(a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent’s proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning.~The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment."|at breath alcohol levels 0.10%, 0.07%, and 0.04%|modified-intent-to-treat (mITT)|||scores on a scale||Standard Error|Least Squares Mean
1456280|NCT00806234|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol Level||From Baseline to Week 24||||mg/dL||Standard Error|Least Squares Mean
1456281|NCT00806234|Secondary|Triglyceride Levels||Change from baseline to 24 weeks||||mg/dL||Standard Error|Least Squares Mean
1456282|NCT00806234|Secondary|Change in Whole Body Insulin Sensitivity Index||Change from baseline to 24 weeks||||mU/L||Standard Error|Least Squares Mean
1456283|NCT00806234|Primary|Body Mass Index (BMI) Z-score Change||Change from baseline to 24 weeks||||Z Score||Standard Error|Least Squares Mean
1456284|NCT00806221|Secondary|Development of Eczema||1 and 2 year time points||||Participants|||Count of Participants
1456285|NCT00806221|Primary|Compliance With Protocol||over two years||||participants|||Number
1456286|NCT00806221|Primary|Incidence of Skin Infection||1 and 2 year timepoints||||Participants|||Count of Participants
1456287|NCT00806221|Primary|Incidence of Skin Irritation||1 and 2 year time points||||Participants|||Count of Participants
1456288|NCT00806195|Secondary|Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination|Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.|||Subjects|||Number
1456289|NCT00806195|Secondary|Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination|To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.|15 minutes to Day 7|Analysis was done on as treated safety population.|||percentages of subjects|||Number
1456290|NCT00806195|Secondary|Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period|To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.|Day 1 (2 months of age) to 18 months of age|Analysis was done on as treated safety population.|||Percentages of subjects|||Number
1456291|NCT00806195|Primary|Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination|"To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."|15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age|Analysis was done on As Treated Safety Population - Subjects who received at least one study dose and provided postbaseline safety data, and that subjects would be included in the group for the vaccination actually received (i.e., analyzed as treated).|||Percentages of subjects|||Number
1456292|NCT00806078|Primary|The Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity. (AUC Inf)|AUC inf is calculated as the sum of the AUC 0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.It is calculated to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol|||ng-h/ml||Standard Deviation|Mean
1456293|NCT00806078|Primary|Area Under the Concentration Time Curve From Zero to t. (AUC 0-t)|The area under the plasma concentration versus time curve from zero to the last measurable plasma concentration as calculated by the linear trapezoidal method. Calculated to determine whether the 2 methods of administration are bioequivalent.|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol|||ng·h/mL||Standard Deviation|Mean
1456294|NCT00806078|Primary|Maximum Observed Plasma Concentration (Cmax)|The highest concentration of drug in plasma after a dose. Measured to evaluate the bioequivalence of the two dosing methods|After dosing at time points 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours|Analysis was performed per protocol|||ng per mL||Standard Deviation|Mean
1456295|NCT00806026|Secondary|Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) at Week 12|WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.|||Percentage of impairment||Standard Deviation|Mean
1457549|NCT00795951|Primary|Diagnostic Performance: Ethylenediamine Dihydrochloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456296|NCT00806026|Secondary|Medical Outcomes Study-Short Form 36 (SF-36) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from “0=much worse now” to “4=much better now”. Higher subscale and summary score reflect better health status.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
1456297|NCT00806026|Secondary|Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12|RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on Scale||Standard Deviation|Mean
1456298|NCT00806026|Secondary|Profile of Mood State (POMS) at Week 12|POMS are participant-rated instrument comprising 6 sub-scales (tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment) and each subscale comprising 5 items, on ‘How you feel right now?’ (Scale: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for vigor-activity. A total score is obtained for each scale. The range of total score is 0 – 100, with higher score indicating more mood disturbance.|Week 12|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to lack of sufficient knowledge as how to analyze mood data inferentially in RLS population.||||||
1456299|NCT00806026|Secondary|Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Participants|||Number
1456300|NCT00806026|Secondary|Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12|MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively.|||Units on a Scale||Standard Deviation|Mean
1456301|NCT00806026|Secondary|Clinical Global Impressions-Severity (CGI-S) at Week 12|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
1456302|NCT00806026|Secondary|Severity of Augmentation Symptoms at Week 12|ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants’ answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
1456303|NCT00806026|Secondary|Change From Baseline in Limb Pain-VAS at Week 12|100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||mm||Standard Error|Least Squares Mean
1456304|NCT00806026|Secondary|Limb Pain-Visual Analog Scale (Limb Pain-VAS)|100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||mm||Standard Deviation|Mean
1456305|NCT00806026|Secondary|Change From Baseline in RLS-NDI at Week 12|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant’s previous night’s sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Error|Least Squares Mean
1456306|NCT00806026|Secondary|RLS-Next Day Impact (RLS-NDI)|The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant’s previous night’s sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
1456307|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a scale||Standard Deviation|Mean
1456308|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||awakenings||Standard Deviation|Mean
1456309|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||hours||Standard Deviation|Mean
1456310|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep.|Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||minutes||Standard Deviation|Mean
1456311|NCT00806026|Secondary|Change From Baseline in SSQ: Subjective WASO at Week 12|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||minutes||Standard Error|Least Squares Mean
1456385|NCT00805441|Secondary|Change From Baseline in Penn Alcohol Craving Scale (PACS)|PACS is a 5-item self-administered instrument that measures frequency, intensity, and duration of thoughts about drinking, ability to resist drinking and craving. Each item ranges from 0-6 with 6 indicating worse symptoms.|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had PACS assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
1456312|NCT00806026|Secondary|Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO)|SSQ: Participant-rated instrument used to assess previous night’s sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep.|Baseline|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||minutes||Standard Deviation|Mean
1456313|NCT00806026|Primary|Percentage of Participants With Augmentation|Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants’ answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation.|Baseline up to Week 52|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Percentage of participants|||Number
1456314|NCT00806026|Primary|Percentage of Participants Responding to Treatment at Week 12|"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of very much improved or much improved."|Week 12|ITT population. Last observation carried forward (LOCF) method was used. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Percentage of participants|||Number
1456315|NCT00806026|Primary|Change From Baseline in the RLS Symptom Severity at Week 12|IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline, Week 12|ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Error|Least Squares Mean
1456316|NCT00806026|Primary|Restless Legs Syndrome (RLS) Symptom Severity|International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life.|Baseline|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively.|||Units on a Scale||Standard Deviation|Mean
1456317|NCT00805961|Secondary|To Assess the Complete Response Rate of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months|||||||
1456318|NCT00805961|Secondary|To Assess the Overall Survival of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen||18 months||||Months||95% Confidence Interval|Number
1456319|NCT00805961|Secondary|To Assess the Toxicity of This Novel Multimodality Regimen||18 months|Information provided in the AEs section||||||
1456320|NCT00805961|Primary|Progression-free Survival (PFS)||18 months||||Months||95% Confidence Interval|Median
1456321|NCT00805935|Secondary|Participants With Treatment Emergent Adverse Events|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Week 1 to week12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study|||Participants|||Number
1456322|NCT00805935|Secondary|Number of Live Births Resulting From the In Vitro Fertilization Process|Number of live births resulting from the IVF process|Approximately 10 months|Database was locked prior to most participants giving birth.|||Live births|||Number
1456323|NCT00805935|Secondary|Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration|Blood tests were sent to a central laboratory to obtain progesterone levels.|approximately day 16||||ng/mL||Standard Deviation|Mean
1456330|NCT00805935|Secondary|Number of Embryos Transferred at Three Stages of Development Before Implantation|"The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.~Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape."|approximately day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Embryos||Standard Deviation|Mean
1456331|NCT00805935|Secondary|Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.|approximately day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Percentage of oocytes retrieved|||Number
1456332|NCT00805935|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.|approximately day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Oocytes||Standard Deviation|Mean
1456333|NCT00805935|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|approximately day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Follicles||Standard Deviation|Mean
1456334|NCT00805935|Primary|Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3|A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|weeks 1-3|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||Participants|||Number
1456335|NCT00805870|Primary|Interleukin-6 Measured in Blood|Interleukin-6 is an indirect indicator of muscle inflammation.|6 days|Number of subjects that completed the protocol. Analysis was per protocol|||pg/mL||Standard Deviation|Mean
1456336|NCT00805870|Primary|Creatine Kinase Activity Measured in Blood|Creatine kinase activity is an indirect indicator of muscle damage.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.|||IU/L||Standard Deviation|Mean
1456337|NCT00805870|Primary|Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge|The required amount of force applied to the quadriceps to elicit pain or discomfort.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.|||lbs||Standard Deviation|Mean
1456338|NCT00805870|Primary|Quadriceps Muscle Strength|Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.|6 days|Number of subjects that completed the protocol. Analysis was per protocol.|||lbs||Standard Deviation|Mean
1456339|NCT00805792|Secondary|Change in Time to Complete Neuropsychological Trail Making Tests A and B at 90 Days Post-stroke|The Trail-making test consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy. It can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning. There are two parts to the test: A, in which the targets are all numbers (1,2,3, etc.)and the test taker needs to connect them in sequential order, and B, in which the subject alternates between numbers and letters (1, A, 2, B, etc.).|baseline, 90 days post-stroke||||seconds||Standard Error|Mean
1456340|NCT00805792|Secondary|Change in Mean Score on Mini Mental State Exam at 90 Days Post-stroke|The mini–mental state examination (MMSE) is a 30-point questionnaire test that is used to screen for cognitive impairment. The questionnaire samples functions including arithmetic, memory and orientation to time and place. Scores range from 0 to 30. Any score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.|baseline, 90 days post-stroke||||units on a scale||Standard Error|Mean
1456341|NCT00805792|Secondary|Change in Mean Barthel Index of Activities of Daily Living Score at 90 Days Post-stroke|The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.|baseline, 90 days post-stroke||||units on a scale||Standard Error|Mean
1456342|NCT00805792|Secondary|Change in Mean National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days Post-stroke|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|baseline, 90 days post-stroke||||units on a scale||Standard Error|Mean
1456343|NCT00805792|Primary|Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at Day 90|The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent’s ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).|90 days post-stroke|Intention-to-treat analysis, all treated participants (n=33). Unobserved because of death (n=3) or loss to follow up (N=2) treated as nonresponse.|||percentage of participants|||Number
1456344|NCT00805766|Secondary|Antibody to TA-650 Determination||Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)||||percentage of participants|||Number
1456346|NCT00805766|Secondary|CDAI Change at Each Evaluation Time Point in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (every 4 weeks for up to 40 weeks)|One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||units on a scale||Full Range|Median
1456347|NCT00805766|Secondary|CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period|CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (every 4 weeks for up to 40 weeks)|Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||percentage of participants||95% Confidence Interval|Number
1456348|NCT00805766|Secondary|CDAI at Each Evaluation Time Point in the Increased Dose Period|CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (every 4 weeks for up to 40 weeks)|One patient whose data after week 4 in the increased dose period was missing was excluded from the analysis. Patients whose the outcome measure were not assessed at a time point due to dropout were excluded from the analysis of the time point.|||units on a scale||Full Range|Median
1456349|NCT00805766|Primary|Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period|To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn’s disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI < 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI > 450 points.|Increased Dose Period (Week 0 to Week 8)||||units on a scale||95% Confidence Interval|Median
1456350|NCT00805740|Secondary|Time to Death|Time to death (days) was assessed as date of death minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.|||days||Full Range|Median
1456351|NCT00805740|Secondary|Percentage of Participants With All-cause Mortality|All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.|Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)|Safety analysis set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1456352|NCT00805740|Secondary|Time to Negative Blood Culture|Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.|Baseline up to 6-week follow-up (6 weeks after EOT)|A sub-set of MITT population included only those participants who had a positive blood culture for Candida species at baseline.|||days||Full Range|Median
1456353|NCT00805740|Secondary|Percentage of Participants With New Infection|New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.|||percentage of participants|||Number
1456354|NCT00805740|Secondary|Percentage of Participants With Relapse|Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.|2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.|||percentage of participants|||Number
1456355|NCT00805740|Secondary|Percentage of Participants With Clinical Response|A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.|Day 10|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species.|||percentage of participants||95% Confidence Interval|Number
1456356|NCT00805740|Secondary|Percentage of Participants With Response Based on Clinical Cure and Microbiological Success|A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.|EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)|MITT population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, ‘n’ signifies those participants who were evaluable for this measure at given time points for each group respectively.|||percentage of participants|||Number
1457550|NCT00795951|Primary|Diagnostic Performance: Balsam of Peru|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456357|NCT00805740|Secondary|Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)|MITT population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species. Only participants who completed therapy or who had global response of failure at EOT were evaluable for 2- and 6-week follow-up analysis.|||percentage of participants||95% Confidence Interval|Number
1456358|NCT00805740|Primary|Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)|Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.|End of Treatment (Day 14 to Day 42)|Modified Intent-To-Treat (MITT) population included all participants who received at least 1 dose of study drug and had a positive culture for Candida species (sp.).|||percentage of participants||95% Confidence Interval|Number
1456359|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Half-live of Free Virus|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||Hours||Standard Deviation|Mean
1456360|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t) I(t) (1 ) (T I(t))V(t) I(t) where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise allinfected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||Percentage||Standard Deviation|Mean
1456361|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||day^-1||Standard Deviation|Mean
1456362|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Viral Clearance|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||day^-1||Standard Deviation|Mean
1456363|NCT00805675|Secondary|Characterization of Very Early Viral Kinetics Through Estimated Viral Load|"The underlying bi‐phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss"|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||log10 copies/ml||Standard Deviation|Mean
1456364|NCT00805675|Secondary|"Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12"|"HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). HBeAg stands for hepatitis B e antigen. This antigen is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the person is infectious and is able to spread the virus to other people."|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. Note: In this analysis 1 patient HBeAg loss in the Telbivudine 600 mg and Tenofovir 300 mg Treatment Group.|||Percentage of Participants|||Number
1456365|NCT00805675|Secondary|Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12|Polymerase Chain Reaction (PCR) Negative is defined as HBV DNA levels <25 copies/ml.|Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once. (1 pat DNA<169 cps/ml)|||Percentage of Participants|||Number
1457374|NCT00796718|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|Up to 15 weeks|All enrolled participants.|||percentage of participants|||Number
1456366|NCT00805675|Secondary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 2, Week 4, Week 8|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||log10 copies/mL||Standard Deviation|Mean
1456367|NCT00805675|Primary|Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.|Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay.|Baseline, Week 12|The Intent to Treat (ITT) data set consisted of the participants that had been randomized and had taken the investigational drug at least once.|||log10 copies/mL||Standard Deviation|Mean
1456368|NCT00805545|Primary|Endometritis and Wound Infection|In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby.|Patients were followed from the time of surgery until 6 weeks postpartum.|All 194 patients who received preoperative antibiotics and who completed the study were analyzed. All 197 patients who received post-cord clamping antibiotics and who completed the study were analyzed.|||patients infected||95% Confidence Interval|Number
1456369|NCT00805493|Primary|Pediatric Anxiety Scale|A standard measure of severity of anxiety over the previous week. The score ranges from a total of 0-25, with 0 being absence of symptoms and impairment, and 25 being marked symptoms and severe impairment. The outcome measure for each participant is the change in PARS, that is, the difference at week 8 compared to baseline (when medication-free).|Weekly for 8 weeks||||units on a scale||Standard Deviation|Mean
1456370|NCT00805493|Primary|Clinical Global Impression--Improvement|This is a clinician rated measure that is a standard in pharmacological trials. the scores range from 1 to 8 with 5 being unchanged, 1 being completely recovered and 8 being markedly worse.|8 week trial with the study running for about 4 years.||||units on a scale||Standard Deviation|Mean
1456371|NCT00805480|Secondary|Percentage of Participants in Each Investigator Global Assessment (IGA) Category|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set participants, who had values at each week category, were included in the analysis. As such, the population at each week varies from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations.|||Percentage of participants|||Number
1456372|NCT00805480|Secondary|Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.|||Percentage of participants|||Number
1456373|NCT00805480|Secondary|Percentage of Participants With at Least 50% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)|PD analysis set: The PD analysis set included participants who had at least one dose of study medication and had no major protocol deviations which could impact the PD analysis. At weeks 28, 36, 44 and 48, only 28 of the 29 participants in the AIN457 10mg/kg X3 group had values for analysis.|||Percentage of participants|||Number
1456374|NCT00805480|Primary|Percentage of Participants Who Had Not Relapsed at Any Time in the Trial|This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56|PD analysis set participants (AIN457 groups only), who had not yet relapsed were included in the analysis at each time point. As a result, the number of participants at risk for relapse may decrease as the number of weeks on study increases. The PD set included participants who had at least one dose of study medication and no protocol deviations.|||Percentage of participants|||Number
1456456|NCT00805194|Secondary|Disease Control|"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||% of participants|||Number
1456375|NCT00805480|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Baseline, Week 12|Participants from the PD Analysis Set, who had both baseline and week 12 values, were included in the analysis. As such, the population for each treatment group is different from the PD population in the participant flow. The PD analysis set included participants who had at least one dose of study medication and had no protocol deviations.|||scores on a scale||Standard Deviation|Mean
1456376|NCT00805467|Secondary|HAQ-DI Score|Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.|||Scores on a Scale||Standard Deviation|Mean
1456377|NCT00805467|Secondary|DAS28-CRP Score|The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily|3 years|Number of participants are those with baseline data. Baseline defined at entry into qualifying study or at entry into this study if more than 14 days since last dose in qualifying study. As no imputation was applied, the numbers at subsequent visits are lower.|||scores on a scale||Standard Deviation|Mean
1456378|NCT00805467|Primary|Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category|AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event|Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)|The full analysis set includes those patients who received at least 1 dose of investigational product, and were summarised according to treatment first received in this study (intention-to-treat principle).|||% of patients|||Number
1456379|NCT00805441|Secondary|12-Item Short-Form Health Survey (SF-12) Scores: Mental Component Summary (MCS)|Short Form 12 (SF-12) is a 12-item assessment used to measure participant’s physical wellbeing [physical component score (PCS)] and mental wellbeing [mental component score (MCS)]. The MCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.|Baseline and Week 12|All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.|||units on a scale||Standard Deviation|Mean
1456380|NCT00805441|Secondary|12 -Item Short-Form Health Survey (SF-12) Scores: Physical Component Summary (PCS)|Short Form 12 (SF-12) is a 12-item assessment used to measure participant’s physical wellbeing [physical component score (PCS)] and mental wellbeing [mental component score (MCS)]. The PCS score ranges from 0 (lowest wellbeing) to 100 (highest wellbeing) and is designed to have a mean of 50 and standard deviation (SD) of 10 in the general population.|Baseline and Week 12|All randomized participants who received at least one dose of study drug and had SF-12 assessed at the specified time points.|||units on a scale||Standard Deviation|Mean
1456381|NCT00805441|Secondary|Change From Baseline in Plasma Carbohydrate Deficient Transferrin (CDT)|Carbohydrate Deficient Transferrin is a laboratory test that measures alcohol consumption. Greater levels suggest recent alcohol consumption.|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had CDT assessed at both baseline and post-baseline.|||percent CDT||Standard Deviation|Mean
1456382|NCT00805441|Secondary|Change From Baseline in Plasma Gamma-Glutamyl Transferase (GGT)||Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had GGT assessed at both baseline and post-baseline.|||units per liter (U/L)||Standard Deviation|Mean
1456383|NCT00805441|Secondary|Change From Baseline Beck Anxiety Index (BAI) Total Score|BAI is a 21-item participant-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0= not present; 3= present in the extreme). Total scores range from 0 to 63. Higher total scores indicate greater severity of anxiety symptoms.|Baseline, Weeks 6 and 12|All randomized participants who received at least one dose of study drug and had BAI assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
1456384|NCT00805441|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score|BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. There is a 4-point scale for each item ranging from 0 (no depression) to 3 (very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression.|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had BDI-II assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
1456479|NCT00804999|Primary|HRT Corneal Scan|Looking for cell density|baseline and 2 hours||||cells/mm^3||Standard Deviation|Mean
1457551|NCT00795951|Primary|Diagnostic Performance: Negative Control|Number of subjects with positive reactions recorded at visit 3 or visit 4.|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456386|NCT00805441|Secondary|Change From Baseline in Alcohol Urge Questionnaire (AUQ)|AUQ measures participant's feeling and thoughts about drinking, and uses a 7 point (1-7) Likert scale for each of 8 items (questions). Scores range from 8 (less urge to drink) to 56 (more urge to drink).|Baseline, Weeks 1 and 2 and 3 and 4 and 6 and 8 and 10 and 12|All randomized participants who received at least one dose of study drug and had AUQ assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
1456387|NCT00805441|Secondary|Change From Baseline in Drinker Inventory of Consequences (DrInC) Subscale and Total Scale|DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. All items for the DrInC are scored from 0-3 with higher scores indicating worse adverse consequences. Interpersonal subscale (10 items: scores range from 0-30) measures the impact of drinking on the participants’ relationships. Physical subscale (8 items: scores range from 0-24) measures adverse physical states resulting from excessive drinking. Social subscale (7 items: scores range from 0-21) measures role fulfillment. Impulsive subscale (12 items: scores range from 0-36) measures sequelae of over drinking. Intrapersonal subscale (8 items: scores range from 0-24) measures subjective perceptions that may not be readily observable by others. Total scores range from 0-150, with higher scores indicating greater severity of symptoms.|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had DrInC assessed at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
1456388|NCT00805441|Secondary|Time to First Heavy Drinking Day|"The Alcohol Timeline Followback (TLFB) is used to assess the time to first heavy drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men. Those who did not drink are considered to be censored."|Baseline up to Week 12|All randomized participants who received at least one dose of study drug and had daily drinking assessed. The numbers of participants censored are 4 for LY686017 group and 3 for placebo group.|||days||Standard Deviation|Mean
1456389|NCT00805441|Secondary|Number of Drinks Per Drinking Day During a Month|The Alcohol Timeline Followback (TLFB) is used in calculating the number of drinks per drinking day. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv).|Baseline and Weeks 4 and 8 and12 and 16|All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.|||drinks/drinking day/month||Standard Deviation|Mean
1456390|NCT00805441|Secondary|Percent Days Abstinent Per Month|The Alcohol Timeline Followback (TLFB) is used in calculating the percentage of days abstinent (days where no alcoholic drinks were consumed). The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Percentage days per month= (number of days where no alcoholic beverages were consumed/number of days in a month)*100.|Baseline and Weeks 4 and 8 and 12 and 16.|All randomized participants who received at least one dose of study drug and had daily drinking assessed at the specified time points.|||percentage days abstinent per month||Standard Deviation|Mean
1456391|NCT00805441|Primary|Percent Change From Baseline in Heavy Drinking Days|The Alcohol Timeline Followback (TLFB) is used in calculating the percent reduction in heavy drinking days. The TLFB is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed each day during last 4 weeks. One standard drink on the TLFB was defined as: 12 ounce (oz) beer [5% alcohol by volume (abv)], 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). Heavy drinking is defined as ≥4 drinks per day for women and ≥5 drinks per day for men.|Baseline, Weeks 4 and 8 and 12 and 16|All randomized participants who received at least one dose of study drug and had daily drinking assessed at both baseline and post-baseline.|||percent of heavy drinking days||Standard Deviation|Mean
1456392|NCT00805389|Secondary|Levels of mRNA as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Nuclear Factor Of Activated T-Cells, Cytoplasmic, Calcineurin-Dependent 2 (NFATC2) and Interferon-gamma (IFN-γ).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
1456508|NCT00804713|Secondary|Positive QFT-GIT Result|The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after enrollment||||participants|||Number
1456393|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by qPCR|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Prostaglandin-Endoperoxide Synthase 2 (PTGS2), Dual Specificity Phosphatase 1 (DUSP1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
1456394|NCT00805389|Secondary|Levels of mRNA as Measured by qPCR|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Chemokine Ligand 10 (CXCL10), Interleukin-1B (IL-1B).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
1456395|NCT00805389|Secondary|Messenger Ribonucleic Acid (mRNA) Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interleukin-12A (IL-12A), Marker Of Proliferation Ki-67 (MKI67).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
1456396|NCT00805389|Secondary|mRNA Levels as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Interferon Regulatory Factor 1 (IRF1), MX Dynamin-Like GTPase 1(MX1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
1456397|NCT00805389|Secondary|mRNA Levels as Measured by qPCR|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Fas associated factor 1 (FAF1), Signal Transducer And Activator Of Transcription 1(STAT1).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
1456398|NCT00805389|Secondary|Levels of Messenger Ribonucleic Acid (mRNA) as Measured by Quantitative Polymerase Chain Reaction (qPCR)|The analysis of the mRNA levels of 14 target genes was performed using whole blood, in the first 140 subjects from the 2 subsets recruited at the Immune Health (IH) centre in La Louvière, Belgium, by microarray/ Polymerase Chain Reaction (PCR) array/ quantitative PCR. Among the target genes were Tumor Necrosis Factor (TNF), Tumor Necrosis Factor Receptor Superfamily (TNFRSF9).|At Days 0, 1, 14, 30, 31, 33 and 37|The ATP cohort for innate immunogenicity up to Day 60 included all evaluable subjects, who complied with the vaccination schedule, for whom data concerning immunogenicity outcome measures were available and for whom innate immunogenicity data were available for at least one post-vaccination time point.|||copies||Full Range|Median
1456399|NCT00805389|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Related to Study Vaccination|A SAE was defined as a medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = occurrence of SAE(s) in a subject regardless of assessment of relationship to study vaccination. Related SAE(s) = occurrence of occurrence of SAE(s) in a subject assessed by the investigators as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1456400|NCT00805389|Secondary|Number of Subjects Reporting Any and Related Adverse Events of Specific Interest (AESIs)|AESIs included Autoimmune Disease (AID), neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, and other autoimmune/inflammatory events. Any AESI(s) = occurrence of any AESI(s) in a subject regardless of assessment of relationship to study vaccination. Related AESI(s) = Occurrence of AESI(s) in a subject assessed by the investigator as causally related to the study vaccination.|During the entire study period, from Day 0 to study end, at Day 360 for subjects not in Subsets 1 & 2 and at Day 390 for subjects in Subsets 1 & 2.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1456424|NCT00805389|Secondary|Number of HB-specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells – expressed through tabulation of interquartile range data – was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
1456401|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Booster Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 31-day (Days 0-30) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.|||Participants|||Count of Participants
1456402|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and/or Related Unsolicited Adverse Events (AEs) Following Primary Vaccination|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination. Grade 3 = occurrence of an AE that prevented normal activity. Related = occurrence of an AE assessed by the investigators as causally related to the study vaccine.|Within the 31-day (Days 0-30) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects.|||Participants|||Count of Participants
1456403|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Booster Vaccination.|Solicited general symptoms assessed were Fatigue, Fever – oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) –, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
1456404|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Booster Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|Within the 7-day (Days 0-6) follow up period following booster vaccination with HBsAg antigens|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
1456405|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Following Primary Vaccination.|Solicited general symptoms assessed were Fatigue, Fever – oral temperature equal to or above (>=) 37.5 degrees Celsius (°C) –, Gastrointestinal symptoms (Gastr.), Headache, Malaise and Myalgia. Any = occurrence of a general symptom regardless of its intensity grade or relationship to vaccination. Related = occurrence of a general symptom assessed by the investigator to be causally related to vaccination. Grade 3 fever = oral temperature above (>) 39.0 °C. Grade 3 for Gastr., Headache, Malaise and Myalgia = occurrence of the specified solicited general symptom which prevented normal activity.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccine.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.|||Participants|||Count of Participants
1456406|NCT00805389|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited Local Symptoms Following Primary Vaccination.|Solicited local symptoms assessed were pain, redness and swelling. All solicited local symptoms were considered as related to study vaccination. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above (>) 50 millimeters (mm). Occurrence of a solicited local symptoms collected post-vaccination was a priori considered as related to vaccination.|Within the 14-day (Days 0-13) follow up period following primary vaccination with the GSK223192A, Fendrix™ or Engerix-B™ vaccines.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, with analysis performed solely on subjects with results from post-primary vaccination available.|||Participants|||Count of Participants
1456407|NCT00805389|Secondary|Number of Subjects Presenting Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.|||Participants|||Count of Participants
1456408|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of RBC, PLA, HGB, ALT, AST, S-CREA, Urea and LDH|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|post vaccination (up to Day 360).|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
1456409|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of Red Blood Cells, Platelets, Haemoglobin, Alanine Aminotransferase, Aspartate Aminotransferase, Serum Creatinine, Urea and Lactate Dehydrogenase|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of red blood cells (RBC), platelets (PLA), haemoglobin (HGB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) at the Day 0 baseline versus their status post vaccination (Day 60).|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
1456410|NCT00805389|Secondary|Number of Subjects Having Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 360 baseline versus their status post vaccination (Day 390). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 360 and 390.|Analysis was done on the Booster Total Vaccinated cohort which included all HLA Subsets 1 and 2 subjects who received the booster dose of HBsAg.|||Participants|||Count of Participants
1456411|NCT00805389|Secondary|Number of Subjects Presenting Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 180 or 360). Day 180 or 360 results were chosen based on assessment of grading of the abnormality observed, with results for higher grading being tabulated.|Post vaccination (up to Day 360)|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Subjects|||Number
1456412|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of WBC, NEU, LYM, MON, EOS, BAS, CRP, and CPK.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
1456413|NCT00805389|Secondary|Number of Subjects With Normal and Abnormal Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, C-reactive Protein, and Creatine Phosphokinase.|Subjects were assessed with regard to their normal (Nor.) and abnormal (Abn.) levels for the above parameters of white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), C-reactive protein (CRP) and creatine phosphokinase (CPK) at the Day 0 baseline versus their status post vaccination (Day 60). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Day 0 and up to Day 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||Participants|||Count of Participants
1456414|NCT00805389|Secondary|Normalized Levels of Serum Creatinine, Urea and Lactate Dehydrogenase|Analysis of levels of serum creatinine (S-CREA), urea and lactate dehydrogenase (LDH) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||cells/mL||Inter-Quartile Range|Median
1456415|NCT00805389|Secondary|Normalized Levels of Haemoglobin, Alanine Aminotransferase and Aspartate Aminotransferase|Analysis of levels of haemoglobin (Hgb), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||cells/mL||Inter-Quartile Range|Median
1456455|NCT00805194|Secondary|Duration of Disease Control|"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
1456416|NCT00805389|Secondary|Normalized Levels of Red Blood Cells and Platelets|Analysis of levels of red blood cells (RBC) and platelets (PLA) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure presents the raw data collected in absolute count, expressed in IH Center normalized levels based on absolute count data (IH normalized abs. count).|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||cells/mL||Inter-Quartile Range|Median
1456417|NCT00805389|Secondary|Levels of WBC, NEU, LYM, MON, EOS and BAS|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||IH normalized ratio||Inter-Quartile Range|Median
1456418|NCT00805389|Secondary|Levels of White Blood Cells, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Levels of white blood cells (WBC) as absolute counts, neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS) and basophils (BAS) were assessed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. This outcome measure presents the raw data collected in percent (%), expressed in IH Center normalized levels based on raw data in % (IH normalized %), and concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||IH normalized ratio||Inter-Quartile Range|Median
1456419|NCT00805389|Secondary|Normalized Levels of CRP|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30 and 37.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||IH Center normalized levels||Inter-Quartile Range|Median
1456420|NCT00805389|Secondary|Normalized Levels of WBC and of CPK|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns all subjects except subjects part of the HLA Subsets 1 and 2.|At Days 0, 30, 37 and 60.|Analysis was done on the Total Vaccinated cohort which included all vaccinated subjects, on subjects for whom results were available for the timepoint/outcome analyzed.|||IH Center normalized ratio||Inter-Quartile Range|Median
1456421|NCT00805389|Secondary|Normalized Levels of C-reactive Protein (CRP)|Analysis of levels of CRP was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||IH Center normlized ratio||Inter-Quartile Range|Median
1456422|NCT00805389|Secondary|Normalized Levels of White Blood Cells (WBC) and Creatine Phosphokinases (CPK)|Analysis of levels of CPK and WBC was performed with reference to the range observed at the Immune Health (IH) Centre in La Louvière, Belgium. Levels are presented as normalized levels vs. the IH center. Normalization was performed as follows: (Raw result – lower limit normal (LLN) at the IH center) divided by (Upper Limit Normal (ULN) at the IH center minus LLN at the IH center). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30, 30+ (Day 30 + 3 to 6 hours), 31, 33, 37 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||IH Center normalized ratio||Inter-Quartile Range|Median
1456423|NCT00805389|Secondary|Concentrations of the Interferon-gamma (IFN-g), Interleukin (IL)-1beta, IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha, IFN-g-inducible Protein-10 and Monocyte Chemotactic Protein-1 Cytokines in Serum|Concentrations of IFN-g, IL-1 beta (IL-1B), IL-5, IL-6, IL-10, Tumor Necrosis Factor-alpha (TNF-a), IFN-g-inducible protein-10 (IP-10) and monocyte chemotactic protein (MCP)-1 Concentrations of the IFN-g, IL-1B, IL-5, IL-6, IL-10, TNF-a, IP-10 and MCP-1 cytokines in serum were measured by Cytokine bead assay (CBA) and expressed in picograms per milliliter (pg/mL). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 0+ (Day 0 + 3 to 6 hours), 1, 30,30+ (Day 30 + 3 to 6 hours), 31, 33 and 37.|Analysis was done on the According-to-Protocol (ATP) cohort for innate immunogenicity to Day 60, which included all evaluable subjects with immunogenicity and innate response (=early immune response [i.e. cytokines in serum, gene expression signature, white blood cells counts]) results available for at least one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
1456425|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Memory B Cells|The number of HB-specific memory B-cells (HB mem-B cells), per million cells – expressed through tabulation of interquartile range data – was measured by B-cell Enzyme-Linked Immunosorbent Spot (ELISPOT) using Peripheral Blood Mononuclear Cells (PBMCs). This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 37, 44 and 60.|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB mem-B cells (per million cells)||Inter-Quartile Range|Median
1456426|NCT00805389|Secondary|Anti-HB Antibody Concentrations in Serum, as Measured by CLIA|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 374 and 390|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1456427|NCT00805389|Secondary|Anti-HB Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||mIU/mL||95% Confidence Interval|Geometric Mean
1456428|NCT00805389|Secondary|Anti-Hepatitis B (Anti-HB) Antibody Concentrations in Serum, as Measured by Chemi Luminescence Immuno Assay (CLIA)|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL). Analysis was initially planned to be performed by Enzyme-Linked Immunosorbent Assay (ELISA). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). Following these laboratory quality issues, GSB Biologicals decided to stop testing with the HBs in-house ELISA and to have the anti-HB analysis performed using the new validated CLIA assay. This outcome measure concerns solely subjects part of the HLA Subsets 1 & 2 who received the Day 360 booster dose of HBsAg.|At Days 0, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||mIU/mL||95% Confidence Interval|Geometric Mean
1456429|NCT00805389|Secondary|Number of HB Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing Th1/Th2 Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
1456430|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells Expressing T Helper Cell Type 1 Response/T Helper Cell Type 2 Response (Th1/Th2) Cytokine Profile|The number of HB-specific CD4+ T cells (per million cells) expressing Th1 and/or Th2 cytokine profile was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
1456431|NCT00805389|Secondary|Number of HB - Specific CD8+ T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 44, 60 and 180|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
1456432|NCT00805389|Secondary|Number of HB - Specific CD4+ T Cells|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), and Tumor Necrosis Factor-alpha (TNF-a) was measured by Intracellular Cytokine Staining (ICS), using whole blood. This analysis was performed solely on eligible subjects enrolled at the Centre for Vaccinology (CEVAC) in Ghent, Belgium.|At Days 0, 14, 30, 33, 37, 44 and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
1456433|NCT00805389|Secondary|Number of HB - Specific CD8+ T Cells|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
1456434|NCT00805389|Secondary|Number of HB - Specific CD4+ T Cells.|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 360 and 374|Analysis was done on the Booster According-to-Protocol (ATP) cohort for immunogenicity which included all subjects from subsets 1 and 2 who received a booster vaccination at Day 360 for whom adaptive immunogenicity data were available for at least one post-booster time point.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
1456435|NCT00805389|Secondary|Number of HB - Specific CD8+ T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
1456436|NCT00805389|Secondary|Number of HB Specific CD4+ T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 180 and 360|Analysis was done on the According-to-Protocol (ATP) cohort for persistence which included all subjects from the ATP cohort for adaptive immunogenicity up to Day 60 for whom adaptive immunogenicity data were available for at least one post-vaccination time point (Day 180 or Day 360).|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
1456437|NCT00805389|Secondary|Number of Hepatitis B (HB) - Specific Cluster of Differentiation 8 (CD8+) T Cells.|The number of HB-CD8+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30, 44, and 60|Analysis was done on the According-to-Protocol (ATP) cohort for adaptive immunogenicity to Day 60, which included all evaluable subjects for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30, 44, or 60 time points.|||HB-CD8+ T cells (per million cells)||Inter-Quartile Range|Median
1456438|NCT00805389|Secondary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD-40L), Interleukin(IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs).|At Days 0, 14, 30 and 60|Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 0, 14, 30 or 60 time points.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
1456439|NCT00805389|Primary|Number of Hepatitis B (HB)-Specific Cluster of Differentiation 4 (CD4+) T Cells .|The number of HB-CD4+ T cells (per million cells) producing 2 or more markers amongst Cluster Differentiation 40 Ligand (CD40L), Interleukin (IL)-2, Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), IL-13 and IL-17 was measured by Intracellular Cytokine Staining (ICS), using frozen Peripheral Blood Mononuclear Cells (PBMCs). Results for the Day 44 time point are the primary results among the outcome measure results presented.|At Day 44|Analyses were performed on the According-to-Protocol (ATP) cohort for adaptive immunogenicity up to Day 60, which included all evaluable subjects who complied with the vaccination schedule and for whom T cell, antibody and memory B cell response data were available for at least one amongst the Day 44 time point.|||HB-CD4+ T cells (per million cells)||Inter-Quartile Range|Median
1456440|NCT00805285|Secondary|C Reactive Protein|Higher values indicated increased disease activity|Week 0 and 8|||||||
1456441|NCT00805285|Secondary|Adverse Events||0, 2, 4, 6, 8, 11, 14, 20, 26, and 52 weeks||||Adverse events|||Number
1456442|NCT00805285|Secondary|ACTH Stimulation Test|An increase in cortisol after stimulation by ACTH is normal. Blood cortisol after ACTH stimulation should be greater than 18 - 20 mcg/dL, depending on the dose of cosyntropin used.|Week 16|||||||
1456443|NCT00805285|Primary|Short Inflammatory Bowel Disease Questionnaire (SIBDQ)|Scores range from 10-70 where higher scores indicated better quality of life.|Week 0 and 8|||||||
1456444|NCT00805285|Primary|Simple Clinical Colitis Disease Activity (SCCAI)|Scores range from 0-19. Higher scores indicated increased disease severity. A score less than 3 is consistent with clinical remission.|0, 2, 4, 6, and 8 weeks|||||||
1456454|NCT00805194|Secondary|Change From Baseline in Tumour Size|"Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion.~Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||percentage of change in tumor size in mm||95% Confidence Interval|Mean
1456445|NCT00805207|Secondary|Basal, Postabsorptive Fractional Synthesis Rates of Muscle Protein Synthesis|"The fractional synthesis rate (FSR) of muscle protein synthesis was determined by assessing the incorporation of [5,5,5-2H3]leucine into muscle proteins. [5,5,5-2H3]leucine was infused for 5 hours with muscle biopsies obtained from the vastus lateralis muscle in the thigh 2 and 5 hours. The leucine tracer-to-tracee ratio (TTR) in muscle protein and the muscle free leucine pool was determined by gas chromatography-mass spectrometry (GCMS) and the FSR of muscle proteins calculated using a standard precursor-product model.~The FSR was calculated as %/h, which reflects the percent of all proteins in the muscle that were synthesized (made) per hour."|Before and at the end of the intervention|"Not included in final analysis:~Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~Muscle not obtained = Testosterone - premenopausal women x 1; Progesterone postmenopausal women x 1; CPAP x 3; Glucocorticoid x 6; Control - baseline testing only x 6."|||%/h||Standard Deviation|Mean
1456446|NCT00805207|Secondary|VLDL-TG Plasma Clearance Rate (Medians)|VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration.|Before and at the end of the interventions|"Not included in final analysis:~Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||mL/min||Inter-Quartile Range|Median
1456447|NCT00805207|Secondary|VLDL-TG Plasma Clearance Rate (Means)|VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The plasma clearance rate of VLDL-TG was calculated by dividing the VLDL-TG secretion rate by the VLDL-TG concentration.|Before and at the end of the interventions|"Not included in final analysis:~Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||mL/min||Standard Deviation|Mean
1456448|NCT00805207|Secondary|Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentration|VLDL was isolated from plasma by ultracentrifugation with VLDL-TG concentration measured by using a colorimetric enzymatic kit (Sigma-Aldrich, St. Louis, MO).|Before and at the end of the interventions|"Not included in final analysis:~Withdrawn/withdrew = Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||mmol/L||Standard Deviation|Mean
1456449|NCT00805207|Primary|Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate|VLDL was isolated from plasma by ultracentrifugation with the tracer-to-tracee (TTR) of free glycerol in plasma and glycerol in VLDL-TG determined by gas chromatography-mass spectrometry. The fractional turnover rates of VLDL-TG was determined by fitting the glycerol TTR time courses in plasma and in VLDL-TG to a multicompartmental model. The hepatic (liver) secretion rates of VLDL-TG was calculated by multiplying the fractional turnover rates of VLDL-TG by the of VLDL-TG concentration.|Before and at the end of interventions|"Not included in final analysis:~Withdrawn/withdrew= Testosterone premenopausal women x 1; Progesterone postmenopausal women x 2; Glucocorticoid x 3.~VLDL-TG fractional turnover rate was 3 Standard Deviations from the mean = Testosterone - premenopausal women x 1.~Undetectable VLDL-TG concentration = Progesterone - Postmenopausal women x 1."|||umol/min/L plasma||Standard Deviation|Mean
1456450|NCT00805194|Secondary|Incidence and Intensity of Adverse Events|"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint."|From the first drug administration until 28 days after the last drug administration, up to 42 months|Treated set- all randomised patients who were documented to have taken at least 1 dose of study medication . Patients were allocated to the treatment groups according to the treatment actually received.|||% of participants|||Number
1456451|NCT00805194|Secondary|Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide|Geometric mean of dose normalised predose plasma concentration (Cpre,ss,norm) of nintedanib and of its metabolites BIBF 1202 and BIBF 1202 glucuronide evaluated at steady state based on course 2 and 3. If only one value was available and valid, then this value was used for calculation of Cpre,ss,norm.|Before the administration of nintedanib or placebo and between a window of 30 mins to an hour after administration of trial drug during Course 2 and between 1 and 3 hours after administration of trial drug during Course 3|Pharmacokinetic set- all patients in the treated set who were documented to have received at least 1 dose of nintedanib and who had at least 1 valid drug plasma concentration available|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
1456452|NCT00805194|Secondary|Quality of Life (QoL)|"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items.~The following were the main points of interest:~Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19).~Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve"|From randomisation until cut-off date 15 February 2013|Randomised set|||months||Inter-Quartile Range|Median
1456453|NCT00805194|Secondary|Clinical Improvement|"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised set|||months||Inter-Quartile Range|Median
1456457|NCT00805194|Secondary|Time to Confirmed Objective Tumour Response|"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
1456458|NCT00805194|Secondary|Duration of Confirmed Objective Tumour Response|"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
1456459|NCT00805194|Secondary|Objective Tumour Response|"Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator."|From randomisation until cut-off date 15 February 2013|Randomised Set|||% of participants|||Number
1456460|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
1456461|NCT00805194|Secondary|Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review|"Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 15 February 2013|Randomised Set|||months||Inter-Quartile Range|Median
1456462|NCT00805194|Secondary|Overall Survival (Key Secondary Endpoint)|"Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~A fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been."|From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients )|Randomised Set|||months||Inter-Quartile Range|Median
1456463|NCT00805194|Primary|Progression Free Survival (PFS) as Assessed by Central Independent Review|"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve."|From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed)|Randomised Set|||months||Inter-Quartile Range|Median
1456464|NCT00805142|Secondary|Patient’s Global Impression of Change (PGI-C)|PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||participants|||Number
1456465|NCT00805142|Secondary|Sleep Questionnaire Regarding the Quality of Sleep|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. Participants rated overall sleep quality on a scale ranging from excellent to very poor.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||participants|||Number
1456466|NCT00805142|Secondary|Sleep Questionnaire Regarding Number of Awakenings|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night . Participants were asked to provide the number of times they awoke at night.|Pre-dose (Day 1) and Day 20|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||awakenings||Standard Deviation|Mean
1456467|NCT00805142|Secondary|Sleep Questionnaire Regarding Time to Sleep and Total Time Slept|The sleep questionnaire is a 4-item questionnaire evaluating the condition of the sleep of the participant on the previous night. The participants were asked about the time taken by them to fall asleep previous night after bedtime and the total time they slept during previous night.|Pre-dose (Day 1) and Day 20|THe PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||minutes||Standard Deviation|Mean
1456468|NCT00805142|Secondary|Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy|The AE is an undesirable or unwanted consequence that occurred during the course of the clinical trial, but not necessarily because of study drug.The AEs included the onset of new symptoms, worsening of the frequency or severity of the symptom compared with Baseline, and abnormal findings including abnormal laboratory test values in the diagnostic examination. The participants who discontinued because of lack of efficacy were those in which satisfactory analgesia was not maintained.|Baseline up to 7 days after last dose of study treatment|The PPS included all participants enrolled excluding those with a major protocol violation.|||participants|||Number
1456524|NCT00804648|Secondary|Conjunctival Hyperemia|Assessed by investigator using a slit lamp and a photographic grading scale. Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
1456469|NCT00805142|Secondary|Rescue Doses|The immediate release (IR) oral opioids were used as rescue doses in the participants with lack of efficacy or to have relief from severe pain. In case of opioid-switching participants rescue doses were continued without any change in the preceding doses or the type throughout the study. The IR morphine HCl was used as the rescue dose for opioid-naive participants. The upper limit of rescue doses was specified for each daily dose of tapentadol PR. There was no change in the dose of rescue medication during maintenance period for opioid-naive participants.|Day 12, 13, 14, 15, 16, 17, 18 and 19|The PPS included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||mg per day||Standard Deviation|Mean
1456470|NCT00805142|Secondary|Pain Assessment Using Visual Analog Scale (VAS) Score|Pain VAS assesses the pain intensity experienced by the participant on a 100 millimeter (mm) VAS, where responses range from a response of no pain (score of 0 mm) to severest pain imaginable (score of 100 mm). The participant indicated the pain by marking the applicable place with slash (/) and the investigator then measured the length from left edge to the slash.|Baseline and Day 19|The PPS included all participants enrolled excluding those with a major protocol violation. Missing values were imputed using last observed carried forward (LOCF) method.|||mm||Standard Deviation|Mean
1456471|NCT00805142|Secondary|Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale|Pain intensity scores were measured on 11 point NRS, where 0 = no pain and 10 = severest pain imaginable. The pain intensity at Baseline was the average of scores on two consecutive morning doses (Day -1 and Day 0) and on Day 20 only a single observation was recorded.|Baseline (Average of Day -1 and Day 0 morning scores), Day 20|The PPS included all participants enrolled excluding those with a major protocol violation.|||units on a scale||Standard Deviation|Mean
1456472|NCT00805142|Secondary|Percentage of Participants Who Achieve Dose Adjustment|Percentage of participants who achieved dose adjustment included those participants whose dose was adjusted during the titration period period and entered the fixed dose maintenance period. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period.|Day 3 up to Day 14|The PPS included all participants enrolled excluding those with a major protocol violation.|||percentage of participants||95% Confidence Interval|Number
1456473|NCT00805142|Primary|Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase|Percentage of participants with sustained pain control for 5 day fixed dose phase were the participants who completed 5 day maintenance period, whose mean Numerical Rating Scale (NRS) score during the fixed dose phase and which was assessed immediately before giving each dose was less than 4 and the number of rescue doses per day for fixed dose phase was 2 or less. Pain intensity scores were recorded 0 to 30 minutes before dose on 11 point NRS where 0 = no pain and 10 = severest pain imaginable.|Day 15 up to Day 19|Per protocol set (PPS) included all participants enrolled excluding those with a major protocol violation. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1456474|NCT00805038|Secondary|Impediments to Successful Intervention||18-24 months|||||||
1456475|NCT00805038|Primary|Number of Steps Completed in Transplant Process|Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.|18-24 months|ITT analysis. Last observation carried forward for preliminary analyses.|||steps per participant||95% Confidence Interval|Mean
1456476|NCT00805025|Secondary|Responsiveness of the Respiratory Domain of the QOL-B as Assessed by the Anchor-based Minimal Clinically Important Difference (MCID) Following Categorization of Level of Change Using the Global Rating of Change Questionnaire (GRCQ)|"The anchor-based method measured the participant's perception of change at Day 28 using the GRCQ, which assesses improving/worsening symptoms. Distribution of ratings was categorized as no change (-1 to 1), minimal change (≥ 1.1 to < 3.1 or ≤ -1.1 to > -3.1), moderate change (≥ 3.1 to < 5.1 or ≤ -3.1 to > -5.1) or large change (≥ 5.1, ≤ -5.1). The GRCQ evaluated change in respiratory symptoms on a visual analog scale from -7 (worsening) to +7 (improvement). The following algorithm was used to obtain the mean change:~If the corresponding GRCQ score was in the “no change” group, then change from baseline QOL-B = Observed QOL-B change from baseline score; if > 1, then change from baseline QOL-B score = Observed QOL-B change from baseline score; if < -1, the change from baseline QOL-B score = (-1) * Observed QOL-B change from baseline score.~Then the mean change from baseline of QOL-B respiratory symptoms score of the minimal change category group is the anchor-based MCID."|Day 0 to Day 28|Participants who were evaluable for MCID and had both GRCQ and QOL-B change values at Day 28 (Visit 4) in any GRCQ domain were analyzed.|||units on a scale||Standard Deviation|Mean
1456477|NCT00805025|Primary|Convergent Validity of the Respiratory Domain of the QOL-B|Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity.|Day -14|Participants were analyzed for respiratory domain score at Day 0 against each of the other variables; those with data for both the respiratory domain score and each variable are reported.|||Pearson correlation coefficient|||Number
1456478|NCT00805025|Primary|Reliability of the Respiratory Domain of the Quality of Life Questionnaire-Bronchiectasis (QOL-B)|"Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability.~The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life."|Day -14 to Day 0|Participants who were treated and had any QOL-B measurements at both Screening and Day 0 (Visits 1 and 2) were analyzed.|||Intraclass Correlation Coefficient|||Number
1456480|NCT00804986|Secondary|Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint|The EuroQoL Questionnaire – 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 12 Weeks||||percentage of participants|||Number
1456481|NCT00804986|Secondary|Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint|Participant chooses where they think their current health state lies on a 10 centimeter line between two anchors (0 - worst imaginable health state and 10 - best imaginable health state). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line. A higher score is associated with better health state. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)|||millimeters||Standard Error|Least Squares Mean
1456482|NCT00804986|Secondary|Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint|DSC-R assesses the presence and perceived burden of diabetes-related symptoms using the following subscales: hypoglycemic, hyperglycemic, psychological, cardiovascular, neurological, ophthalmological. Participants evaluate symptoms based on a 5-point Likert-type scale, ranging from 1=not at all troublesome to 5=extremely troublesome. Higher scores indicated greater severity of symptoms within a domain, or poorer perceived health, respectively. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)|||units on a scale||Standard Error|Least Squares Mean
1456483|NCT00804986|Secondary|Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint|Impact of Weight on Quality of Life (IWQoL) - Lite Version consists of 31 items from 5 subscales: physical functioning, self-esteem, sexual life, public distress, and work as well as a total score. Individual item scoring ranges from 0 (never true) to 4 (always true) with total score range from 0 to 124. Higher scores on the subscales and total score correspond with lower levels of functioning or greater negative effect. LSMean adjusted for baseline, baseline HbA1c (less than 8.5% versus greater than or equal to 8.5%), metformin use, treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement, last observation carried forward (LOCF) up to visit 9 (week 12)|||units on a scale||Standard Error|Least Squares Mean
1456484|NCT00804986|Secondary|Change in Fasting Weight From Baseline to Week 12 Endpoint|LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
1456485|NCT00804986|Secondary|Change in Fasting Lipids From Baseline to Week 12 Endpoint|Fasting lipids were measured after overnight fasting of at least 8 hours. Lipids analyzed include triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and total-cholesterol. LSMean adjusted for baseline and treatment.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement. The last post-baseline measurement was carried forward if the value at week 12 was missing.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
1456486|NCT00804986|Secondary|Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the C-peptide concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for C-peptide represents the area that is under the curve of C-peptide values when they are plotted over time. Larger AUC values represent a greater average C-peptide value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
1456487|NCT00804986|Secondary|Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in insulin secretory response. The area under the insulin concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for insulin represents the area that is under the curve of insulin values when they are plotted over time. Larger AUC values represent a greater average insulin value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||picomole per minute per liter||95% Confidence Interval|Least Squares Mean
1456488|NCT00804986|Secondary|Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint|An oral glucose tolerance test (OGTT) was used to assess changes in glucose tolerance. The area under the plasma glucose concentration versus time curve was calculated using the linear-trapezoidal method. Area under the curve (AUC) for glucose represents the area that is under the curve of glucose values when they are plotted over time. Larger AUC values represent a greater average glucose value over time. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||milligrams per minute per deciliter||95% Confidence Interval|Least Squares Mean
1456489|NCT00804986|Secondary|Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint|Self-monitored glucose levels measured at 7 timepoints during the day. Timepoints include: fasting pre-breakfast, 2 hours post breakfast, prior to lunch, 2 hours post lunch, prior to dinner, 2 hours post dinner, and prior to bed. LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||milligrams per deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
1456490|NCT00804986|Secondary|Total Average Concentration (Cavg) of LY2428757|Average concentration (Cavg) is calculated as the AUC0-168 (area under the plasma concentration vs. time curve during one dosing interval of 168 hours) divided by 168 hours. The numbers presented reflect the average LY2428757 drug concentration circulating in the body over 168 hours (one dosing interval).|4 weeks, 6 weeks, 8 weeks, 10 weeks|All randomized participants|||nanograms per milliliter (ng/mL)|||Number
1456491|NCT00804986|Secondary|Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study|Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY2428757. If a participant developed a positive anti-LY2428757 antibody titer, appropriate medical management was to be utilized at the discretion of the sponsor and investigator, if deemed necessary.|baseline through 16 weeks|All randomized participants|||participants|||Number
1456492|NCT00804986|Secondary|Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint|The VAS scales for appetite (hunger) and satiety (how full) were recorded on a scale with range of possible scores from 0 to 100 represented in millimeters on a 10 centimeter line. For appetite, participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - not at all hungry and 10 - extremely hungry). For satiety, participant chooses where they think their satiety lies on a 10 centimeter line between two anchors (0 - not at all full and 10 - extremely full). LSMean adjusted for baseline, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||millimeters (mm)||Standard Error|Least Squares Mean
1456493|NCT00804986|Primary|Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint|LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.|baseline, 12 weeks|Modified intention to treat population, defined as all randomized participants with at least one post-baseline measurement.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1456494|NCT00804908|Secondary|Time to Neurological/Brain Metastases Progression|Time to neurological/brain metastases progression, defined as the number of days from the date of randomization to the date the participant experienced an event of neurological/brain metastases progression, was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the distribution are provided. All events of progression were included, regardless of whether the event occurred while the participant was still taking study drug. If a participant did not experience an event, data were censored at the date of the last available brain CT scan. For participants with no postbaseline brain CT scans, data were censored at randomization. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
1456495|NCT00804908|Secondary|Disease Control Rate|The disease control rate was defined as the percentage of participants who had at least stable disease (complete response, partial response, or stable disease) through the end of Week 8. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Week 8|ITT population defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1456496|NCT00804908|Secondary|Time to Disease Progression|The distribution of time to disease progression, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
1456497|NCT00804908|Secondary|Objective Response Rate|The objective response rate was defined as the percentage of participants with a confirmed CR or PR per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography (CT) scan: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|All subjects in the ITT population (defined as all randomized participants) with measurable disease.|||percentage of participants||95% Confidence Interval|Number
1456506|NCT00804713|Other Pre-specified|Battey Skin Test Result|Battey skin test positive results defined as >= 100 mm reaction. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours after administration||||participants|||Number
1456507|NCT00804713|Other Pre-specified|T-Spot Result|Positive T-Spot results. The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.|48-72 hours||||participants|||Number
1456498|NCT00804908|Secondary|6-month Progression-Free Survival Rate|The 6-month progression-free survival rate was defined as the percentage of participants without disease progression at 6 months.The distribution of 6-month progression-free survival rate, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1456499|NCT00804908|Secondary|12-Month Overall Survival (OS) Rate|The 12-month overall survival rate was defined as the percentage of participants surviving at 12 months. The distribution of 12-month OS rate was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.|Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months.|ITT population defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1456500|NCT00804908|Secondary|Overall Survival (OS): Time to Event|OS was defined as the number of days from the date the participant was randomized to the date of death. All deaths were included, whether the participant was still taking or had discontinued study drug. If a participant had not died and was lost to follow-up, then data were censored at the last study visit or contact date, or date the participant was last known to be alive, whichever was later; if the participant was not lost to follow-up, then data were censored at the last study visit or contact date, whichever was later. The distribution of OS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the OS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints.|Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
1456501|NCT00804908|Primary|Progression-Free Survival (PFS): Time to Event|PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided.|Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.|ITT population defined as all randomized participants.|||days||95% Confidence Interval|Number
1456502|NCT00804843|Primary|Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay|Cholesterol ester was to be calculated by the following formula: Cholesterol Ester = Total Cholesterol – Free Cholesterol.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were to be included in the analysis. This was not performed due to technical concerns. Instead, the cholesterol content determination, if performed, will use mass spectrometry approach and would be an exploratory objective.||||||
1456503|NCT00804843|Primary|Plaque Instability Protein Composite Score|Each excised plaque was analyzed using an assay of 20 proteins that reflect plaque composition and inflammation. Each protein was assigned scaled signs, with a lower (negative) sign associated with plaque stability and a higher (positive) sign associated with plaque inflammation/instability. The Composite Score was the average amounts of all the 20 proteins with their associated signs. A higher Composite Score is associated with more plaque instability.|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.|||Score||Standard Deviation|Mean
1456504|NCT00804843|Primary|Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis|"Excised carotid plaques were evaluated for the gene expression of 60 biomarkers associated with inflammation (Hot biomarkers) & 25 biomarkers associated with stability (Cold biomarkers). Each biomarker was assayed using a quantitative polymerase chain reaction method and results were reported as a Cycle Threshold, (Ct). A Composite Score was calculated by averaging the Ct for each of the 25 cold genes, and subtracting the average Ct for the 60 hot genes. A higher composite score was associated with greater inflammation and a lower score was associated with stability (non-inflamed)."|At time of carotid endarterectomy (after 4 to 12 weeks of dosing)|Only participants who completed the study, had evaluable plaque samples and were at least 80% compliant with dosing schedule were included in the analysis.|||Cycle threshold (Ct)||Standard Deviation|Mean
1456505|NCT00804713|Other Pre-specified|TST Results for the Population for Which All 4 Tests Have Valid Results and no Borderline Results||48-72 hours after adminstration||||participants|||Number
1456509|NCT00804713|Primary|TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.|"Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.)~The number of 1803 is used here because that is the number for which valid results were available for all 4 tests.~The number presented in each category is the number of participants that had positive results.~We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol."|48-72 hrs post administration||||participants|||Number
1456510|NCT00804687|Secondary|Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1|The MCA was measured using AcR which is an objective measurement of nasal congestion that assesses nasal cavity geometry (that is, MCA) and changes in the dimensions of the nasal cavity. Change from Baseline in MCA is the value at particular time point minus value at Baseline.|Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||square centimeter (cm^2)||Standard Deviation|Mean
1456511|NCT00804687|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. Change from Baseline in TNSS is the value at particular time point minus value at Baseline.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1456512|NCT00804687|Secondary|Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)|The TNSS was the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Participants assessed each individual symptoms on a scale of 0-3 where: 0=absent, 1=mild, 2=moderate and 3=severe. TNSS score ranges from 0 to 12 and higher scores indicate worsening. The AUC of TNSS was used as response variable to assess the treatment effect. AUC was adjusted for Baseline TNSS scores. Baseline TNSS was defined as the symptom scores for each treatment period at pre-dose (approximately 2 hour before EEC entry).|2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period|The ITT population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||units on a scale * hours||Standard Deviation|Mean
1456513|NCT00804687|Primary|Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry|The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber [EEC] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.|2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period|Intent to treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-baseline AcR efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||square centimeter*hour (cm^2*h)||Standard Deviation|Mean
1456514|NCT00804648|Secondary|Visual Acuity|The visual acuity score is a count of the number of letters the subject successfully read from the eye chart. The higher the score, the better the vision.|following 3 days of treatment||||number of letters||Standard Deviation|Mean
1456515|NCT00804648|Secondary|Conjunctival Staining - Temporal Count|Assessed by investigator using a slit lamp and counting number of spots.|following 3 days of treatment||||number of spots||Standard Deviation|Mean
1456516|NCT00804648|Secondary|Conjunctival Staining - Temporal Grade|Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
1456517|NCT00804648|Secondary|Conjunctival Staining - Nasal Count|Assessed by investigator using slit lamp and counting number of spots.|following 3 days of treatment||||number of spots||Standard Deviation|Mean
1456518|NCT00804648|Secondary|Conjunctival Staining - Nasal Grade|Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided. The higher the grade the worse the staining.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
1456519|NCT00804648|Secondary|Basic Schirmer's|Schirmer's measures basic tear function. The higher the number, the less dry the eye.|following 3 days of treatment||||mm of moisture||Standard Deviation|Mean
1456520|NCT00804648|Secondary|Intraoclular Pressure||following 3 days of treatment||||mm of mercury||Standard Deviation|Mean
1456521|NCT00804648|Secondary|Corneal Staining Count|Assessed by the investigator using a slit lamp, counting the number of spots.|following 3 days of treatment||||Number of spots||Standard Deviation|Mean
1456522|NCT00804648|Secondary|Corneal Staining Grade|Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5. The higher the grade the worse the staining.|following 3 days of treatment||||Units on a scale||Standard Deviation|Mean
1456523|NCT00804648|Secondary|Tear Film Break-up Time||following 3 days of treatment||||Seconds||Standard Deviation|Mean
1456526|NCT00804609|Primary|Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)|The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.|a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
1456527|NCT00804596|Secondary|Number of Capillary Blood Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new Blood Glucose Monitoring System (BGMS) with subject capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects.|1-2 hours|Since each subject provided two blood glucose (BG) meter results, 2x74 (or 148) subject BG test results were possible. For each subject blood sample, a healthcare professional (HCP) provided two BG meter results so that 2x74 (or 148) BG results were possible for HCP test results.|||Number of Duplicate Results (n=74x2)|||Number
1456528|NCT00804596|Primary|Percentage of Participants Rated as <=3 (Comprehension of Labeling)|"Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was:~Successful in performing tasks correctly without assistance~Successful after being referred to user instructions~Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|1-2 hours|per protocol|||percentage of participants|||Number
1456529|NCT00804570|Secondary|Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Total Score at Week 16 Endpoint|The GSRS is a clinician-administered scale used to assess upper and lower gastrointestinal physical symptoms. 15 items covering domains of abdominal pain, reflux syndrome, indigestion syndrome, diarrhea syndrome, and constipation syndrome were assessed with a 1-week recall period. Total scores range from 0-45. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456530|NCT00804570|Secondary|Number of Participants With Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar)≥10 at Any Time From Baseline Through Week 16 Endpoint|The revised CIWA-Ar scale measured the severity of alcohol withdrawal by rating 10 signs and symptoms: nausea; tremor; autonomic hyperactivity; anxiety; agitation; tactile, visual, and auditory disturbances; headache; and disorientation. Total scores range from 0-67. Higher scores indicate greater severity of withdrawal.|Baseline through Week 16|Participants who took at least one dose of study drug.|||participants|||Number
1456531|NCT00804570|Secondary|Change From Baseline in Orthostatic Pulse Rate at Week 16 Endpoint|Orthostatic pulse rate is the pulse rate measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||beats per minute||Standard Error|Least Squares Mean
1456532|NCT00804570|Secondary|Change From Baseline in Orthostatic Blood Pressure (BP) at Week 16 Endpoint|Orthostatic BP is the BP measured within 3 minutes of standing. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16||||mmHg||Standard Error|Least Squares Mean
1456533|NCT00804570|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|Percentage of participants had one or more TEAEs during treatment period. TEAE is a worsening or new occurrence of adverse event during treatment compared to baseline.|Baseline through Week 16|Participants who took at least one dose of study drug.|||percentage of participants|||Number
1456534|NCT00804570|Secondary|Percentage of Participants Discontinuation Due to Adverse Events (AEs)|Percentage of participants discontinued study due to one or more AEs.|Baseline through Week 16|Participants who took at least one dose of study drug.|||percentage of participants|||Number
1456535|NCT00804570|Secondary|Change From Baseline in QTc Fridericia's Correction Interval (QTcF) Measured by Electrocardiograms at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||milliseconds||Standard Error|Least Squares Mean
1456536|NCT00804570|Secondary|Change From Baseline in Supine Pulse Rate at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1456537|NCT00804570|Secondary|Change From Baseline in Supine Blood Pressure (BP) at Week 16 Endpoint|Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, baseline, treatment*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants who took at least one dose of study drug.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1456538|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Volume of Distribution|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.|||Liter (L)||Standard Error|Mean
1456539|NCT00804570|Secondary|Population Pharmacokinetic (PK) - Apparent Clearance|Plasma concentrations were analyzed using population PK methodology with non-linear mixed effect modeling (NONMEM) software.|Over 16 weeks|Participants who took study drug and contributed PK sample.|||Liter/hour (L/hr)||Standard Error|Mean
1456594|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 6|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.|||participants|||Number
1456540|NCT00804570|Secondary|Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at Week 16 Endpoint|EWPS is a self-rated work productivity scale that assesses such topics as work hours, work missed, and behaviors and feelings related to the workplace. The EWPS will be completed only by subjects who work outside the home. There are 25 items and total scores range from 0-100. Higher scores indicate poorer productivity. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456541|NCT00804570|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 16 Endpoint|Q-LES-Q-SF is a self-report instrument that assesses the degree of enjoyment and satisfaction in daily life activities. The domains include: social relationships, living or house situation, and physical health. Total scores range from 14-70. Higher scores indicate better quality of life. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456542|NCT00804570|Secondary|Change From Baseline in Thoughts About Abstinence Scale at Week 16 Endpoint|Thoughts About Abstinence Scale was to measure participant's commitment to abstinence. It includes 3 items on a scale of 1-10: own desire to stop drinking (1=no desire to quit); own expectation of success in quitting (1=lowest expectation of success); how difficult to quit and remain abstinent (1=lowest amount of difficulty); and their goal related to alcohol use (scale of 1-7: 1=having no goal, up to total abstinence at 6 [7 was none of 6 above]). Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456543|NCT00804570|Secondary|Change From Baseline in Barratt Impulsivity Scale-11 (BIS-11) Total Score at Week 16 Endpoint|The BIS-11 is a 30-item, self-administered impulsivity scale. Motor, cognitive, and non-planning domains are assessed and a total score is computed. This scale has previously been used in substance-abusing populations. Total scores range from 30-120. Higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456544|NCT00804570|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) Total Score at Week 16 Endpoint|BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Participant was asked to rate how much he or she has been bothered by each symptom over the past week. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). Total scores range from 0 to 63. The higher the score, the more severe the anxiety symptoms. LS Mean value was controlled for treatment, pooled investigator, gender, family history, visit, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456545|NCT00804570|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II) Total Score at Week 16 Endpoint|The BDI-II contains 21 items that characterize how the subject was feeling in the past 2 weeks. There is a 4-point scale for each item ranging from 0 to 3 (0=no depression; 3=very depressed). Total scores range from 0-63. Higher scores indicate greater severity of depression. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456546|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Aspartate Transaminase (AST) Level at Week 16 Endpoint|AST is a potential biomarker for LY2196044 efficacy as decreases reflect decreased alcohol consumption. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||ratio||Standard Error|Geometric Mean
1456547|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Percent Carbohydrate-Deficient Transferrin (%CDT) Level at Week 16 Endpoint|Gamma-Glutamyltransferase (GGT) and %CDT will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||ratio||Standard Error|Geometric Mean
1456548|NCT00804570|Secondary|Ratio of Geometric Means Over Baseline in Gamma-Glutamyltransferase (GGT) Level at Week 16 Endpoint|GGT and carbohydrate-deficient transferrin (%CDT) will be used as biochemical markers of alcohol consumption. A combination of GGT and %CDT improves the sensitivity of detecting excessive alcohol consumption as compared to either marker alone, or other traditional markers. Elevated levels indicate heavy alcoholism. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||ratio||Standard Error|Geometric Mean
1456549|NCT00804570|Secondary|Change From Baseline in Drinker Inventory of Consequences (DrInC) - Recent Consequences (DrInC-2R) Total Score at Week 16 Endpoint|DrInC is a self-administered, 50-item questionnaire designed to measure adverse consequences of alcohol abuse in 5 areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. DrInC-2R provides a measurement since the last interview. Total scores range from 0-150, and higher scores indicate greater severity of symptoms. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, baseline, gender*family history, treatment*visit, baseline*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456550|NCT00804570|Secondary|Change From Baseline in Obsessive Compulsive Drinking Scale (OCDS) Total Score at Week 16 Endpoint|Cravings will be assessed using the OCDS. The OCDS is a 14-item self-rating instrument. Total scores range from 0-40. Higher scores indicate more obsessive and craving. Least Squares (LS) Mean value was controlled for treatment, site, visit, gender, history, baseline, gender*history, treatment*visit, baseline*visit, gender*treatment, gender*treatment*visit. Subject was treated as a random effect. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1456551|NCT00804570|Secondary|Change From Baseline in Drinks Per Heavy Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||number of drinks/heavy drinking day||Standard Error|Least Squares Mean
1456552|NCT00804570|Secondary|Change From Baseline in Drinks Per Drinking Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed on the days the participant drank. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||number of drinks/drinking day||Standard Error|Least Squares Mean
1456553|NCT00804570|Secondary|Change From Baseline in Percentage of Days Abstinent at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the percentage of days abstinent. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||percentage of days||Standard Error|Least Squares Mean
1456554|NCT00804570|Secondary|Change From Baseline in Drinks Per Day at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of drinks consumed per day. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Baseline, Week 16|Participants with a baseline and post-baseline value.|||number of drinks/day||Standard Error|Least Squares Mean
1456555|NCT00804570|Primary|Percentage of Heavy Drinking Days at Week 16 Endpoint|The Timeline Followback Method assesses the subject’s daily drinking by means of a calendar that covers a specific time period and was used to assess the number of heavy drinking days. Heavy drinking is defined as ≥4 drinks/day for women and ≥5 drinks/day for men. Least Squares (LS) Mean value was controlled for treatment, pooled investigator, visit, gender, family history, treatment*visit, gender*family history, baseline, and baseline*visit. An unstructured covariance structure was used.|Week 16|Participants with a baseline and post-baseline value.|||percentage of days||Standard Error|Least Squares Mean
1456556|NCT00804193|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject’s current episode of tinea pedis|6 weeks||||participants|||Number
1456557|NCT00804193|Secondary|Proportion of Subjects With Mycological Cure|Potassium hydroxide [KOH] wet mount negative and fungal culture negative|6 weeks||||participants|||Number
1456558|NCT00804193|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure|6 weeks|Per protocol population|||participants|||Number
1456559|NCT00803959|Secondary|Stress Test at 12 Mos|A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test. The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments.|Screen and 12 months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Of these, only 225 in the UDS arm and 222 in the no UDS had stress test data at 12 months.|||percentage of participants|||Number
1456560|NCT00803959|Secondary|Patient Satisfaction With Treatment Outcome|A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction.|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456561|NCT00803959|Secondary|Moderate or Severe Severity as Measured by the PGI-S|"The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe]. This measure is the percentage of participants responding to the PGI-S with a 3 corresponding to the moderate category or a 4 corresponding to the severe category at the 12 month visit."|12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. One woman was missing PGI-S data in the UDS arm and was excluded leaving n=271 in the UDS arm.|||percentage of participants|||Number
1456648|NCT00803413|Secondary|Spine Flexibility (3rd Fingertip to Floor – 3FF).|Patients in up-right position with joined feet and stretched out arms were asked to bend the spine as much as possible without bending the knees; the least achieved distance between the 3rd fingertip and the floor was measured in centimeters with a proper rule.|6 months||||centimeters||Standard Deviation|Mean
1456562|NCT00803959|Secondary|Change in Severity as Measured by the PGI-S|The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe]. Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456563|NCT00803959|Secondary|Change in Quality of Life as Measured by the SF-12|The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health. Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200. The larger the positive value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456564|NCT00803959|Secondary|Change in Quality of Life as Measured by the IIQ|Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life. Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456565|NCT00803959|Secondary|Change in MESA Urge Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA urge score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456566|NCT00803959|Secondary|Change in MESA Stress Score|The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA stress score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.|Screen & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456567|NCT00803959|Secondary|Change in Severity as Measured by the ISI|Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline & 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456568|NCT00803959|Secondary|Change in Bother as Measured by the UDI|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.|Baseline, 12 Months|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||units on a scale||Standard Deviation|Mean
1456569|NCT00803959|Secondary|Patient Global Impression Index|"Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants,~How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage?” Responses are on a 7-point scale from 1 meaning “very much better” to 7 meaning~very much worse.” Values of very much better (1) or much better (2) were considered to have perceived improvement according to this criteria. Values of 3 or greater were not (e.g. a little better, no change, a little worse, much worse or very much worse). This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence."|12 Months|315 women were randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Two were missing PGI-I data in the UDS arm and 4 in the no UDS arm; sample size was 262 in no UDS arm and 270 in the UDS arm.|||percentage of participants|||Number
1456774|NCT00802685|Primary|Days Spent on Supplemental Oxygen During the First 28 Days.||28 days of life|The number of participants for analysis was determined from all subjects who completed the study intervention at 28 days of age and had complete data on the primary endpoint of oxygen days during the first 28 days. Analysis was done on intention to treat basis.|||days||Full Range|Median
1456570|NCT00803959|Secondary|Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months|The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial.|Baseline, 12 mos|There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.|||percentage of participants|||Number
1456571|NCT00803959|Primary|"Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and Very Much or Much Better on the Patient Global Impression of Improvement Measure at 12 Mos."|"Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of~“very much better” or “much better” at 12 months."|12 Months|There were 315 women randomized to each of the arms. In the no UDS arm (and UDS arm), 49 (43) did not have primary outcome data, leaving 266 (272) included in the ITT analysis. Of these, 259 (264) were included in the PP analysis with primary outcome data. The PP analysis was the primary analysis because the outcome was a non-inferiority endpoint.|||percentage of participants|||Number
1456572|NCT00803790|Secondary|Part II : Maximum Concentration (Cmax) of Vitamin D|Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Periods 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.|||ng/ml||Standard Deviation|Least Squares Mean
1456573|NCT00803790|Primary|Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D|The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.|Day 1 across the 80-hour plasma collection period (Period 1 and 2)|60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.|||ng*hr/mL||Standard Deviation|Least Squares Mean
1456574|NCT00803790|Primary|Part 1: Urinary Excretion of Alendronate|Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at –2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.|Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)|220 participants of the 251 enrolled in Part 1 were included in the statistical analysis. 31 participants were excluded: 23 were enrolled but did not complete both study periods and 8 participants had incomplete urine profiles in one or both periods.|||μg||Standard Deviation|Least Squares Mean
1456575|NCT00803777|Secondary|Average Within Replicate Coefficient of Variation CV (Precision)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|1-2 hours|Meter results were used from subject and HCP data that had numeric values for duplicate BG self-tests. One subject data set was not used because subject was given carbohydrate to prevent low blood sugar. Two subjects' meter results contained outliers (NCCLS EP-9A) and one HCP's results had only one replicate result so these sets were not analyzed.|||percentage CV|||Number
1456576|NCT00803777|Secondary|Number of Participants Rated as <=2 (Labeling Comprehension)|"Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:~Successful in performing tasks correctly without assistance~Successful after study staff prompted participant to review User Guide.~Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)~Subject did not perform task correctly and study staff intervention was required."|1-2 hours|For 2 different subjects, study staff did not rate subject success at 1 task.|||participants|||Number
1456577|NCT00803777|Secondary|Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies|The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences|1-2 hours|Some subjects >=13 yrs consented to provide larger capillary samples for YSI glucose analysis. One subject's sample was insufficient to run the YSI analysis. Another subject’s results were not useable as the subject was given carbohydrate to prevent low blood sugar. Duplicate subject BG results provided 158 possible data points.|||Number of BG results in zone (n=79x2)|||Number
1456578|NCT00803777|Primary|Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results|Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.|1-2 hours|One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.|||number of Subject BGM Results (n=146x2)|||Number
1456579|NCT00803777|Primary|Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated.|1-2 hours|Some subjects >=13 years old consented to provide larger capillary samples for YSI glucose analysis. Subjects and HCPs provided duplicate results, but one subject's HCP provided only one glucose result. One subject sample was too small to run the YSI analysis; another subject was given carbohydrate to prevent low blood sugar (no results obtained)|||number of capillary results (n=79x2)|||Number
1456580|NCT00803751|Secondary|POGO Score With 2nd Laryngoscopy|POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.|Before patient is intubated||||Score||Standard Deviation|Mean
1456581|NCT00803751|Primary|Quality of Laryngeal View Obtained With 2nd Laryngoscopy|The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.|during laryngoscopy prior to intubation (few minutes prior to intubation)||||Participants|||Number
1456582|NCT00803751|Secondary|POGO Score With 1st Laryngoscopy|POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.|Before patient is intubated (few minutes before intubation)||||Score||Standard Deviation|Mean
1456583|NCT00803751|Secondary|Time Taken for Intubation||throughout the intubation procedure||||seconds||Standard Deviation|Mean
1456584|NCT00803751|Primary|Number of Intubation Attempts|Number of participants with the indicated number of intubation attempts (1/2/3)|during intubation prior to surgery||||Participants|||Number
1456585|NCT00803751|Primary|Quality of Laryngeal View Obtained on Comarck Lehane Classification|The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.|during laryngoscopy prior to intubation. Few minutes before intubation||||Participants|||Number
1456586|NCT00803738|Secondary|Proportion of Subjects With Clinical Cure|"A subject was considered a clinical cure if all of the following were satisfied:~All signs and symptoms with a score of 1 (mild) or 2 (moderate) at the Screening/Baseline visit were absent (score = 0), and all signs or symptoms with a score of 3 (severe) at Screening/Baseline had a score of 0 or 1.~Total signs and symptoms did not worsen at any time following completion of the study treatment.~Any new sign or symptom observed during the study period was determined by the Investigator not to be related to VVC.~The subject did not require additional vulvovaginal or systemic antifungal therapy at any time during the study period.~The subject did not use any topical drug therapy other than the study medication for the treatment of vulvovaginal irritation and/or pruritus such as topical analgesic or corticosteroid products"|Visit 3: Day 22-31|per protocol population|||participants|||Number
1456587|NCT00803738|Secondary|Proportion of Subjects With Mycological Cure|Mycological cure was defined as a negative mycological culture (no growth) for Candida albicans or other relevant baseline yeast organism.|Visit 3: Day 22-31|Per protocol population|||participants|||Number
1456588|NCT00803738|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Cure|The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.|Visit 3: Day 22-31|Per Protocol (PP) population|||participants|||Number
1456589|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 12|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.|||participants|||Number
1456590|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Maintenance Phase|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.|||participants|||Number
1456591|NCT00803712|Secondary|Subject Incidence of Hyperphosphatemia During the Efficacy Assessment Phase at Month 6|Hyperphosphatemia is defined as at least one serum phosphorus value >= 5.5 mg/dL|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one serum phosphorus value during the time period of interest.|||participants|||Number
1456592|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Efficacy Assessment Phase at Month 12|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.|||participants|||Number
1456593|NCT00803712|Secondary|Subject Incidence of Hypercalcemia During the Maintenance Phase|Hypercalcemia is defined as at least one corrected serum calcium value >= 10.2 mg/dL|Weeks 26-48|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started, and also had at least one corrected serum calcium value during the time period of interest.|||participants|||Number
1456972|NCT00799773|Secondary|All Cause Mortality||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456595|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
1456596|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
1456597|NCT00803712|Secondary|Summary of Percent Change From Baseline in Serum Phosphorus at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
1456598|NCT00803712|Secondary|Summary of Serum Phosphorus (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
1456599|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
1456600|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
1456601|NCT00803712|Secondary|Summary of Percent Change From Baseline in Corrected Serum Calcium at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
1456602|NCT00803712|Secondary|Summary of Corrected Serum Calcium (mg/dL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phase|||mg/dL||95% Confidence Interval|Least Squares Mean
1456603|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
1456604|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 12 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||pg/mL||95% Confidence Interval|Least Squares Mean
1456605|NCT00803712|Secondary|Summary of Percent Change From Baseline in iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||percent change||95% Confidence Interval|Least Squares Mean
1456606|NCT00803712|Secondary|Summary of iPTH (pg/mL) at Month 6 Efficacy Assessment Phase|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phase|||pg/mL||95% Confidence Interval|Least Squares Mean
1456607|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during the efficacy assessment phases|||participants|||Number
1456608|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during the efficacy assessment phases|||participants|||Number
1456609|NCT00803712|Secondary|Achievement of a Mean iPTH <=300 pg/mL During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases|||participants|||Number
1456610|NCT00803712|Secondary|Achievement of a >= 30% Reduction in Mean iPTH From Baseline to During Both Efficacy Assessment Phases at Month 6 (Weeks 22 to 26) and Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phases were used in the calculation of the mean over the period. For subjects with no measurements taken during an EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26 and Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during the efficacy assessment phases|||participants|||Number
1456611|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 48-52|||participants|||Number
1456612|NCT00803712|Secondary|Achievement of a Mean Serum Phosphorus < 5.5 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a serum phosphorus value during weeks 22-26|||participants|||Number
1456613|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 48-52|||participants|||Number
1456614|NCT00803712|Secondary|Achievement of a Mean Corrected Serum Calcium < 10.2 mg/dL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without a corrected serum calcium value during weeks 22-26|||participants|||Number
1456615|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52|||participants|||Number
1456616|NCT00803712|Secondary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 12 (Weeks 48 to 52)|All available measurements from the efficacy assessment phase (EAP) at month 12 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 48-52|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 48-52|||participants|||Number
1456617|NCT00803712|Secondary|Achievement of a Mean PTH <= 300 pg/mL During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For subjects with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all subjects who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for subjects without an iPTH value during weeks 22-26|||participants|||Number
1456618|NCT00803712|Primary|Achievement of a ≥ 30% Reduction in Mean PTH From Baseline to During the Efficacy Assessment Phase at Month 6 (Weeks 22 to 26)|All available measurements from the efficacy assessment phase (EAP) at month 6 were used in the calculation of the mean over the period. For participants with no measurements taken during the EAP, the mean of the last 2 measurements available after Day 1 were carried forward. If there was only 1 value available, this single value was carried forward to the EAP.|Weeks 22-26|Analysis based on the full analysis set, including all participants who were randomized into the study and had at least one iPTH value available after the day study treatment started. Last observation carried forward was used for participants without an iPTH value during weeks 22-26|||participants|||Number
1456619|NCT00803686|Secondary|AUCInhibition=Hours*%P|The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.|12 Hours||||hours*%P||Standard Deviation|Mean
1456620|NCT00803686|Secondary|Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women|See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition).|12 hours|Data from Part 1 (crossover Periods 1 and 2) were pooled to give CTx-1 mean data for the oral rsCT tablet group (n = 12) and for the oral placebo group n = 12). Part 2, open-label, non-crossover, compared the CTx-1 results after oral rsCT (n = 5) with those after Fortical(n = 4. The % inhibition is reported first.|||Hours||Standard Deviation|Mean
1456621|NCT00803686|Primary|Pharmacodynamic Effect of Oral Calcitonin|C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc|12 hr|Not applicable. All participants who received treatment were included.|||percentage of time-matched placebo respo||Standard Deviation|Mean
1456622|NCT00803647|Secondary|Recurrence-free Survival (RFS). Time From Study Entry Until First Recurrence.||2 years|Patients with R0 resection|||months||95% Confidence Interval|Median
1456623|NCT00803647|Secondary|Objective Clinical Response Rate (cRR). Measureable Lesions That Can be Accurately Measured in at Least One Dimension With Conventional Radiologic Techniques or Spiral CT.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by PET/CT, CT scan, MRI or spiral CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective clinical Response Rate (cRR) = CR + PR during the 3 preoperative cycles, among the treated patients.|8 months||||percentage of participants||95% Confidence Interval|Number
1456624|NCT00803647|Secondary|Overall Survival (OS). Time From Study Entry Until Death From Any Cause.|The percentage of patients alive at 18 months.|18 months||||percentage of participants||95% Confidence Interval|Number
1456625|NCT00803647|Primary|Reported Adverse Events.|19 participants experienced at least one adverse event. There were a total of 95 adverse events reported. (Note: multiple occurrences of the same adverse event in one individual are counted only once.) Refer to the Adverse Events section for specifics. The Other Adverse Events section lists only those events occurring above 5% frequency.|8 months||||adverse events|||Number
1456626|NCT00803647|Primary|The Percentage of Patients Who Had a Curative (R0) Liver Metastasectomy Following Protocol Treatment, i.e., Metastatic Disease That Can be Completely Resected and/or Ablated With no Postoperative Evidence of Residual Malignant Disease (R0 Resection).||8 months|All 20 patients were included in this outcome measure.|||percentage of participants||95% Confidence Interval|Number
1456627|NCT00803634|Primary|Percentage to First Achieve Initial Prespecified SBP Target Range [≥20 mm Hg and ≤40 mm Hg Apart] and 15% Reduction From Baseline Within First 30 Minutes|Analysis of the percentage of patients achieving both components of this composite endpoint (attainment of the initial prespecified SBP target range and a 15% reduction in SBP from baseline) was calculated within each treatment group using the number of mITT patients achieving the SBP reduction goal divided by the number of mITT patients, and multiplied by 100.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
1456628|NCT00803634|Secondary|Number of Patients That Require Intubation During Study Drug Administration up to 96 Hours|The number of patients requiring intubation was calculated based on the total number of mITT patients.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Patients|||Number
1456629|NCT00803634|Secondary|Percentage of Patients With at Least One Episode of SBP < 90 mm Hg During Study Drug Administration (up to 96 Hours)|The percent of patients with at least one episode of SBP <90 mm Hg was calculated as the number of mITT patients who had at least one episode of SBP<90 mm Hg during study drug administration up to 96 hours divided by mITT patients, and multiplied by 100 for each treatment group.|Initiation through termination of study drug (up to 96 hours)|Safety population: All randomized and eligible patients who were dosed with study drug.|||Percentage of patients||95% Confidence Interval|Number
1456630|NCT00803634|Secondary|Percentage of Patients Who Received Any Alternative IV Antihypertensive Drug at Any Time During Study Drug Treatment|The percentage of patients who received any alternative IV antihypertensive drug at any time during the study drug treatment period (up to 96 hours) was calculated using mITT patients within each treatment group.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
1456631|NCT00803634|Secondary|Time to Use Other IV Antihypertensives During the Study Drug Administration|The length of time to use other IV antihypertensive agents was defined as the duration in hours from the initiation of study drug through the time when any other concomitant IV antihypertensive agent was administered, thus, representing the time period without use of any other concomitant IV antihypertensive agent. Median time to use other IV antihypertensive agents was obtained using Kaplan-Meier method. If a patient did not receive any concomitant IV antihypertensive during the 96-hour treatment period, this patient was considered censored at 96 hours. If study drug was stopped less than 96 hours and the patient has no concomitant IV antihypertensive agent, the patient was considered censored when study drug was stopped.|Initiation of study drug through any other concomitant IV antihypertensive agent administered, up to 96 hours|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Hours||95% Confidence Interval|Median
1456632|NCT00803634|Secondary|Change From Baseline in Dyspnea (Measured By VAS) at Each Time Point|A validated visual analog scale (VAS) with a horizontal ruler showing increments from 0 to 100 mm with 0 = Best and 100 = Worst was used. The test was asked from the patient's perspective and had to be administered with patient sitting. Relative change in VAS from baseline is the value at each time point minus the baseline value. Relative change from baseline was summarized descriptively (with associated two-tailed 95% CIs of the mean values) at 15, 30 and 45 minutes and at 1, 2, 3 hours and 12 hours, and 1 hour post termination of study drug treatment.|Baseline (immediately prior to study drug administration) through 1 hour after study drug termination|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||millimeters (mm)||Standard Deviation|Mean
1456633|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range at Any Time During Study|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the entire study drug treatment period (up to 96 hours) was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation through termination of study drug (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
1456634|NCT00803634|Secondary|Percentage Falling Below Lower Limit of SBP Target Range Within First 30 Minutes|The percentage of patients in whom the SBP fell below the lower limit of the prespecified target range at any time during the first 30 minutes was calculated within each treatment group using the number of mITT patients achieving the endpoint divided by the number of mITT patients and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
1456635|NCT00803634|Secondary|SBP Area Under the Curve (AUC) Outside Prespecified Target Range|The magnitude and duration of SBP excursions was calculated as the area under the curve (AUC) for each patient, using the trapezoidal rule, related to time (in minutes) that each patient’s SBP was outside the target range. AUC was determined based on data collected from the initiation of study medication through the end of monotherapy treatment up to 96 hours, normalized per hour, and expressed as mmHg × minute/hour.|Initiation of study drug through end of monotherapy (up to 96 hours)|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||mm Hg x min/h||Standard Deviation|Mean
1456636|NCT00803634|Secondary|Percentage Reaching Prespecified Target Range Without Falling Below Lower Limit of Target Range Within First 30 Minutes|The percentage of patients reaching this endpoint was calculated within each treatment group using the number of mITT patients reaching the endpoint divided by the number of mITT patients, and multiplied by 100. Two-tailed 95% CIs were computed for these percentages.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Percentage of patients||95% Confidence Interval|Number
1456637|NCT00803634|Primary|Time to First Achieve Initial Prespecified SBP Target Range and 15% Reduction From Baseline Within First 30 Minutes|Time to first achieve the initial pre-specified systolic blood pressure (SBP) target range and a 15% SBP reduction from baseline is the time in minutes between the initiation of study medication and the time the patient first achieved both components. Median time was estimated using Kaplan Meier method. 95% two-sided confidence interval of the median time is from 'Simon and Lee, 1982'. If patients did not reach both components within 30 minutes from the initial treatment with study medication, or another antihypertensive agent was administered, the patient was censored at 30 minutes or the time when another antihypertensive agent is given, whichever came first.|Initiation of study drug through the initial 30-minutes|mITT population: All randomized and eligible patients who were dosed with study drug and have a baseline SBP ≥160 mm Hg, at least one post-baseline on-treatment SBP measurement, and a confirmed diagnosis of AHF|||Minutes||95% Confidence Interval|Median
1456638|NCT00803595|Secondary|Time for Body Temperature to Return to Normal|Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored.|15 days||||hours||95% Confidence Interval|Median
1456639|NCT00803595|Primary|Time to Alleviation of Influenza Illness|The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were “absent” or “mild.” Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored.|15 days|Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data.|||hours||95% Confidence Interval|Median
1456640|NCT00803543|Primary|Rate of Asymptomatic HSV-2 Genital Shedding|Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.|24 weeks||||Proportion of days|Total Number of Days Assessed||Number
1456641|NCT00803543|Primary|Number of Participants With an HIV Viral Load of <500 Copies/ml|Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks|24 weeks||||Participants|||Number
1456642|NCT00803543|Primary|CD4 Count|CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml|24 weeks||||cells/ml||Full Range|Mean
1456643|NCT00803543|Primary|Herpes Simplex Virus Type 2 Recurrence|Number of recurrences of genital herpes|24 Weeks|No participants reported genital herpes recurrence during the study.|||Recurrence|||Number
1456644|NCT00803517|Secondary|Best Corrected Visual Acuity|Best-corrected visual acuities were obtained with Snellen charts. Snellen’s visual acuity was converted logarithm of the minimum angle of resolution (logMAR) for statistical analysis.|baseline, 1 month, 3 months, 6 months||||logMAR||Standard Deviation|Mean
1456645|NCT00803517|Primary|Multifocal Electroretinogram Amplitudes|"Amplitude at first annular ring at multifocal electroretinogram RETIscan (Roland Consult, Wiesbaden, Germany) is used for multifocal retinogram.~The recording protocol was chosen according to the International Society for Clinical Electro-physiology of Vision (ISCEV) guidelines."|baseline, 1 month, 3 months, 6 months||||microvolts||Standard Deviation|Mean
1456646|NCT00803452|Primary|Global Response to Therapy|Global Response to Therapy (itch, dryness, burning and swelling of eyes) as assessed with a questionnaire completed by the subjects. The questionnaire asked subjects to rate their improvement on a scale from 4 to 0 with 4 being resolution of symptoms and 0 being no improvement. Data reported here represent the number of eye of subjects that reported that their symptoms were resolved or improved in each eye.|4 weeks||||eyes|eyes||Number
1456647|NCT00803413|Primary|Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)|Patients were asked to indicate their perception about their LBP intensity with a cross on a line without marks, ranging from 1 (very light pain) through 10 (very strong pain)|6 months||||milimeters||Standard Deviation|Mean
1456649|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I)|The Clinical Global Impression Improvement Scale is a 7 point ordinal scale that assesses how much the patient's illness has improved or worsened relative to a baseline state before the intervention. Rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Baseline and 12 weeks|For this outcome the baseline number of participants is zero as at the first visit patients have not received any treatment yet, thus they cannot be assessed with a scale that measures improvement at their first visit. This scale will only be applied along weeks 2, 4, 8, and 12, after patients have received their corresponding treatments.|||Units on a scale||Standard Deviation|Mean
1456650|NCT00803400|Secondary|Participants´Endpoint Change From Baseline in Clinical Global Impression Severity Scale (CGI-S)|The Clinical Global Impression Severity scale is a 7 point ordinal scale that rates the severity of the patient's illness, assessing on the severity of a patient’s mental illness. It ranges from 1 to 7 (1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; 7, extremely ill).|Baseline and 12 weeks||||Units on a scale||Standard Deviation|Mean
1456651|NCT00803400|Primary|Participants´Endpoint Change From Baseline in Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale is a test that consists of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).|Baseline and 12 weeks||||Units on a scale||Standard Deviation|Mean
1456652|NCT00803361|Secondary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
1456653|NCT00803361|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Pain at Endpoint|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain).|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
1456654|NCT00803361|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Endpoint, Global Functioning Scores|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual item scores range from 0-10, with higher numbers indicating greater disruption. Item 1 is for work/schoolwork, Item 2 is for social life/leisure activities, Item 3 is for family life/home responsibilities.|Baseline, Week 15|Participants with a baseline and at least one post-baseline value.|||Units on a scale||Standard Deviation|Mean
1456655|NCT00803361|Secondary|Change From Baseline in Brief Pain Inventory (BPI) - Short Form Severity (BPI-S) and Interference (BPI-I) Scores at Endpoint|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
1456656|NCT00803361|Secondary|Mean Clinical Global Impressions (CGI) Improvement Score at Endpoint|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).|Week 15|Participants with at least one post-baseline result within each treatment group.|||Units on a Scale||Standard Deviation|Mean
1456657|NCT00803361|Secondary|Change From Baseline in the Hamilton Anxiety (HAMA) Rating Scale Total Score at Endpoint|The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a scale||Standard Deviation|Mean
1456658|NCT00803361|Primary|Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Endpoint|A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'|Baseline, Week 15|Participants with a baseline and at least one post-baseline result within each treatment group.|||Units on a scale||Standard Deviation|Mean
1456659|NCT00803283|Secondary|Mean Total Daily Dose (TDD) of Study Medication|Mean total daily dose of study medication taken during study will be recorded by participants.|Baseline up to day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456660|NCT00803283|Secondary|Number of Times the Pain Medication Required for Breakthrough Pain|The requirement of breakthrough pain medication will be recorded by participants. Morphine HCl, 10 mg, will be used as rescue medication for breakthrough pain.|Baseline up to Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456661|NCT00803283|Secondary|Investigator's Global Assessment on Effectiveness|Investigator will evaluate effectiveness by providing rating on the question “‘what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase” using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456662|NCT00803283|Secondary|Patient's Global Assessment on Effectiveness|Participants will evaluate effectiveness by providing rating on the question “‘what is your rating of the overall effectiveness of the study medication during the titration or maintenance phase” using 5-point scale ranging from 1 to 5, where 1=poor,. 2=fair, 3=good, 4=very good and 5=excellent.|Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456663|NCT00803283|Secondary|"BPI Questionnaire Item Pain Interference Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Interference will be assessed using the BPI questionnaire. Pain interference of general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life will be rated on a scale ranging from 0 (no interference) to 10 (complete interference)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456664|NCT00803283|Secondary|"BPI Questionnaire Item Pain Relief Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Relief will be assessed using the BPI questionnaire. Pain relief was rated on a scale ranging from 0% (no relief) to 100% (complete relief)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456665|NCT00803283|Secondary|"BPI Questionnaire Item Pain Intensity Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item Pain Intensity will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456666|NCT00803283|Secondary|"BPI Questionnaire Item 6 How Much Pain You Have Right Now Score"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 6 how much pain you have right now will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Baseline, Day 14, Day 22 and Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456667|NCT00803283|Primary|"BPI Questionnaire Item 3 Worst Pain Score at Day 28"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 28|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456668|NCT00803283|Primary|"Brief Pain Inventory (BPI) Questionnaire Item 3 Worst Pain Score at Day 14"|"The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Total score ranges from 0=no pain to 10=extreme pain. BPI Questionnaire Item 3 Worst Pain will be assessed using the BPI questionnaire, score ranges from 0 (no pain) to 10 (pain as bad as you can imagine)."|Day 14|Study was terminated due to poor enrollment and no efficacy data were summarized due to very low sample size. Only safety data were summarized.||||||
1456669|NCT00803270|Secondary|Optimal Outcome of Treatment at 3 Months|"Composite measure defined as much better or very much better om PGI-I and normal or mild on PGI-S. PGI-I is a single item: Circle the one answer that best describes how your urinary tract condition is now, compared with how it was before your incontinence treatment with responses ranging from 1=Very much better to 7=Very much worse. PGI-S is a single items: Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1=Normal to 4=Severe."|3 months|Participants who attended 3 month follow-up visit|||participants|||Number
1456670|NCT00803270|Primary|Optimal Outcome of Treatment at 6 Months|"Composite measure defined as much better or very much better on Patient Global Impression of Improvement (PGI-I) and normal or mild on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment with responses ranging from 1= Very much better to 7= Very much worse. The PGI-S is a single item:; Circle the one number that best describes how your urinary tract condition is now with responses ranging from 1 = Normal to 4 Severe."|6 Months|Participants who attended 6 month follow-up visit|||participants|||Number
1456671|NCT00803244|Post-Hoc|Combined Score (CS)|"The daily Combined Score (CS) is a patient specific score taking into account the patient’s daily Rhinoconjunctivis Total Symptom Score (RTSS) and daily Rescue Medication Score (RMS), assuming equivalent importance of symptoms and rescue medication scores.~The RMS (range 0-3) is derived as follows: 0, no rescue medication; 1, use of antihistamine; 2, use of nasal corticosteroid; 3, use of oral corticosteroid. The RTSS (range 0-18) is the sum of the 6 individual rhinoconjunctivitis symptom score (each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms and 3: severe symptoms).~The CS (range 0-3) = (RTSS/6 + RMS)/2. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Combined Score during the pollen period while on treatment.|||Units on a scale (range: 0 to 3)||Standard Error|Least Squares Mean
1456686|NCT00803101|Primary|Percentage of Participants Achieving Hemostatic Efficacy During Surgery|"Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of excellent or good, and 'non-effective' was a hemostatic efficacy rating of poor/none."|From the start of infusion until the end of surgery|The Intention-to-Treat Efficacy ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1456687|NCT00803062|Other Pre-specified|Prevalence of Active Smoking|An estimate of the prevalence of active smoking will be calculated. Will be assessed for associations with progression and/or death.|Up to 5 years|||||||
1456672|NCT00803244|Primary|Average Adjusted Symptom Score (AAdSS)|"The Adjusted Symptom Score (AdSS) is a subject-specific symptom score which is adjusted for rescue medication use.~Participants assessed daily, during the pollen period while on treatment, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). If the subject took rescue medication on a given day, the AdSS equals the RTSS of that day or the AdSS of the day before, whichever is higher. This adjustment applies to the day of rescue medication use and the following day. Like the RTSS, the AdSS ranges from 0 to 18. The lower the score, the better the outcome."|Pollen period (average of 32.1 days)|The Full Analysis Set included all patients who received at least one dose of the investigational product and had at least one Adjusted Symptom Score during the pollen period while on treatment.|||Units on a scale (range: 0 to 18)||Standard Error|Least Squares Mean
1456673|NCT00803179|Secondary|Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy||14 months|||||||
1456674|NCT00803179|Primary|Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy||14 months|||||||
1456675|NCT00803114|Secondary|Side Effects|Number of participants with pruritus, nausea and vomiting, urinary retention, drowsiness in the first 24 hours postpartum|at 24 hours postpartum|||||||
1456676|NCT00803114|Secondary|Maternal Satisfaction With Perineal Pain Management|"5 point Likert scale asking for agreement with the statement I was satisfied with my pain relief for the pain in my bottom during the first day after delivery. Scale ranged from strongly disagree to strongly agree."|at 24 hours postpartum||||participants|||Number
1456677|NCT00803114|Secondary|Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic|"Participants were asked to indicate on a 10 cm line the point at which their perineal pain scored between one end anchored with no pain in my bottom to the other end anchored with the worst pain in my bottom that I can imagine"|by 24 hours postpartum||||scores on a scale||Standard Deviation|Mean
1456678|NCT00803114|Secondary|Time to First Request for Analgesia|All participants requested analgesia at least once during their hospitalization|Hours||||hours||Standard Deviation|Mean
1456679|NCT00803114|Primary|The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum||24 hours postpartum|Analysis by intention to treat.|||participants|||Number
1456680|NCT00803101|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. TEAEs were defined as adverse events that developed or worsened following exposure to investigational medicinal product. Treatment-related TEAEs were events whose relationship to study treatment was related, probably related, or possibly related in the opinion of the investigator. Treatment emergent adverse events with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent serious adverse events (SAEs).|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs|The Intention-to-Treat Safety (ITT-S) population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.|||participants|||Number
1456681|NCT00803101|Secondary|Percentage of Participants Who Received Red Blood Cells|Red blood cells were PRBCs and whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
1456682|NCT00803101|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
1456683|NCT00803101|Secondary|Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood|The total units of transfused PRBCs or whole blood|From the start of surgery until 24 h after the start of surgery|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||units of PRBCs or whole blood||Standard Deviation|Mean
1456684|NCT00803101|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From pre-infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of normal||Standard Deviation|Mean
1456685|NCT00803101|Primary|Percentage of Participants Who Had a Rapid Decrease of the INR|A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after the end of infusion|The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1456710|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 6 Months||||units on a scale||Standard Deviation|Mean
1456688|NCT00803062|Other Pre-specified|Number of CTCs|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
1456689|NCT00803062|Other Pre-specified|Levels of Tumor Measures of Angiogenesis|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
1456690|NCT00803062|Other Pre-specified|Levels of Cell-free DNA in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
1456691|NCT00803062|Other Pre-specified|Levels of Angiogenesis Markers in Plasma|Associations between biomarkers and overall survival or progression-free survival will be examined in a Cox proportional hazards model that includes significant prognostic variables based on prior research such as performance status, prior cisplatin therapy, and stage of disease. Logistic regression will be used to help assess the value of biomarkers in predicting response to a particular treatment or determine associations with response.|Up to 5 years|||||||
1456692|NCT00803062|Other Pre-specified|Health-related Quality of Life|Assessed by FACT-Cx TOI; FACT/GOG-Ntx4 subscale; and BPI at baseline, before courses 2 and 5, and at 6 and 9 months after course 1. The linear mixed model will be used to evaluate the hypotheses on FACT-Cx TOI score, adjusting for baseline FACT-Cx TOI scores and age. A mixed-effects mixed-distribution model will be considered to analyze NTx4 subscale scores and the BPI score. 95% confidence intervals will be reported for the estimated treatment differences of BPI score.|Up to 9 months after course 1|||||||
1456693|NCT00803062|Other Pre-specified|Extent of Nicotine Dependence|Assessed from answers the patients provide to a questionnaire. Will be assessed for associations with progression and/or death.|Up to 5 years|||||||
1456694|NCT00803062|Primary|To Determine and Compare the Frequency and Severity of Adverse Events as Assessed by CTCAE Version 3.0 for the Regimens Administered on This Study.|The number of patients on each arm who have Grade 3 AE or higher toxicity.|From date of enrollment until 30 days after treatment completion|Eligible and treated patients|||Participants|||Count of Participants
1456695|NCT00803062|Primary|Tumor Response|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions by CT, MRI or CXR. If the only target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in longest diameter is required; Overall Response (OR) = CR + PR.|Every cycle (if assessed by physical exam), every other cycle (if assessed by imaging), after the final cycle, then every 3 months x 2 years, then every 6 months x 3 years up to 5 years.|All randomized patients.|||percentage of participants||95% Confidence Interval|Number
1456696|NCT00803062|Primary|Progression-free Survival|"Disease that can be assessed clinically (physical examination) should be evaluated every cycle (every 3 weeks). Disease assessed by imaging modalities (CXR, CT, MRI) should be evaluated every other cycle unless other evidence of a change mandates earlier assessment. Tumor measurements should also be done after the final cycle (if the patient is taken off of study therapy for a reason other than progression) and then every 3 months x 2 years (followed with every 6 months x 3 years) until progression is documented. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|From study entry until disease progression, death or date of last contact, assessed up to 5 years (During treatment: every 3 weeks if by physical exam, every 6 weeks by CXR, CT or MRI. In follow-up: quarterly for 2 years then semi-annually for 3 years)|All randomized patients.|||months||95% Confidence Interval|Median
1456697|NCT00803062|Primary|Overall Survival|The observed length of life from randomization into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, assessed up to 5 years|All randomized patients.|||months||95% Confidence Interval|Median
1456698|NCT00803049|Secondary|Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Volume of Abnormal Lesions (Burden of Disease [BOD]) at Week 192 Since LTS6050 Randomization|BOD was assessed by cerebral MRI and defined as the total volume of all abnormal brain tissue (calculated as the sum of the total volume of T2-lesion component and T1-hypointense lesion component).|Baseline, Week 192|ITT (LTS6050 population). Number of participants analyzed=participants with available data for this outcome measure.|||millilitres (ml)||Standard Deviation|Mean
1456699|NCT00803049|Secondary|Annualized MS Relapse Rate (ARR): Poisson Regression Estimates|"ARR was obtained from total number of confirmed relapses that occurred during treatment period divided by sum of treatment durations in LTS6050 study only. Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever was to be confirmed by an increase in EDSS score or Functional System (FS) scores. EDSS: an ordinal scale qualifies disability. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). FSS: to assess the neurological function. Total score range: 0 (normal) - 6(worse), higher scores = worse neurological function. To account for the different treatment duration among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Up to 8 years since LTS6050 randomization|ITT(LTS6050) population: all participants who were randomized in the LTS6050 study and had at least 1-day IMP exposure during the LTS6050 study.|||relapses per participant-year||95% Confidence Interval|Number
1456700|NCT00803049|Secondary|Percentage of Participants Free of Sustained Disability Progression (DP)|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks and 24 weeks. EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicates worse neurological function. Percentage of participants who were considered as free of disability progression confirmed after 12 week sustained progression and 24 week sustained progression were reported. Analysis for this outcome measure was performed on combined data of EFC6049 and LTS6050 study, as pre-specified in protocol.|Up to 10.8 years since EFC6049 randomization (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049 [NCT00134563] + LTS6050) population.|||percentage of participants|||Number
1456701|NCT00803049|Secondary|Time to 24 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP was defined as sustained increase of at least 1 point from baseline (EFC6049) EDSS score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 24 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to MS). Probability of DP at 24 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.|||Probability||95% Confidence Interval|Number
1456702|NCT00803049|Secondary|Time to 12 Week Sustained Disability Progression (DP): Kaplan-Meier Estimates of the Rate of DP|Sustained DP defined as sustained increase of at least 1 point from baseline (EFC6049) expanded disability status scale (EDSS) score (0.5 point for participants with baseline EDSS>5.5) persisting for at least 12 weeks. EDSS: an ordinal scale qualifies disability in participants with MS. EDSS total score range: 0 (normal neurological examination) to 10 (death due to Multiple Sclerosis [MS]). Probability of DP at 12 weeks was estimated using Kaplan-Meier method on time to DP defined as date of first DP minus (-) date of randomization in EFC6049 study +1 day. Participants free of DP (no DP observed on treatment) were censored at the date of last on-treatment EDSS evaluation in LTS6050. Kaplan-Meier method consists in computing probabilities of non-occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t.|Up to 10.8 years (EFC6049: 108 weeks + LTS6050: 450 weeks)|Intent-to-treat (ITT) (EFC6049+ LTS6050) population: all participants randomized in both EFC6049 and LTS6050 studies that had at least 1-day IMP exposure during both EFC6049 and LTS6050 studies. Analysis for this outcome measure was performed on the combined data of EFC6049 andLTS6050 study, as pre-specified in the protocol.|||Probability||95% Confidence Interval|Number
1456703|NCT00803049|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during on-treatment period which was defined as the period from the time of first dose of study drug (in LTS6050) up to 4 weeks (28 days) after last dose of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.|Baseline (LTS6050) up to 28 days after last dose of study drug up to 450 weeks|Safety population: all participants randomized in the LTS6050 study and exposed to IMP during the LTS6050 study treatment period, regardless of the amount of treatment administered. The safety analysis was conducted as the treatment received.|||percentage of participants|||Number
1456704|NCT00803023|Secondary|Tolerability Assessed by Adverse Events||4 weeks|||||||
1456705|NCT00803023|Primary|Summary of Most Frequent Adverse Events (Per Arm) Experienced by Study Subjects||4 weeks||||participants|||Number
1456706|NCT00803010|Secondary|2 Year Post Transplant Overall Survival (OS) Rate|Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to death from any cause .|2 years|All participants who received treatment|||percentage of participants||95% Confidence Interval|Number
1456707|NCT00803010|Secondary|Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)|Absolute numbers of Treg at designated time points according to study arm. MTX = methotrexate/tacrolimus-treated patients; SIR = sirolimus/tacrolimus-treated patients; Treg absolute number units = number of cells/microL. A two-sided Wilcoxon's rank-sum test was employed to test differences in percent Treg (% Treg/total CD4+ cells).|30 days and 90 days||||Cells/MicroL||95% Confidence Interval|Median
1456708|NCT00803010|Primary|Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant|"Incidence of acute graft versus host disease grades 2-3 according to the Common Toxicity Criteria (CTC) version 3.~Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). Clinical evidence of acute GVHD was recorded per standard grading scheme.~Acute GVHD classified as the following:~classic acute GVHD - onset within 100 days after transplant~persistent – acute GVHD with onset prior to day 100 and without resolution beyond day 100~recurrent – acute GVHD recurrent after prior episode of acute GVHD~late acute GVHD – syndrome consistent with acute GVHD, without features of chronic GVHD, with onset occurring beyond 100 days"|100 Days Post Transplant|All participants who received treatment|||percentage of participants||95% Confidence Interval|Number
1456709|NCT00802997|Other Pre-specified|Pain Status Change for Sacroiliac Joint Pain Intensity|Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain.|Baseline and 9 Months||||units on a scale||Standard Deviation|Mean
1456712|NCT00802945|Secondary|Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE was any event not present before exposure to the study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug. All AEs were assessed for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. If a particular AE was not listed in the NCI CTCAE Version 3.0, the following criteria were used: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life threatening or disabling; Grade 5 = Death.|Up to 2 years.||||percentage of subjects|||Number
1456713|NCT00802945|Secondary|Kaplan Meier Estimate of 1-year Survival|One year survival (i.e., overall survival proportion at 12 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.|From Cycle 1 Day 1 to the end of 12 months.||||percentage of subjects||95% Confidence Interval|Number
1456714|NCT00802945|Secondary|Kaplan Meier Estimate of 6-month Survival|Six-month survival (i.e., overall survival proportion at 6 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population.|From Cycle 1 Day 1 to the end of 6 months.||||percentage of subjects||95% Confidence Interval|Number
1456715|NCT00802945|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|OS was calculated as the time from the date of first study drug administration until death from any cause. Subjects alive at the time of analysis were censored at the time they were last known alive. OS was analyzed for the ITT population.|Up to 2 years.||||Months||95% Confidence Interval|Median
1456716|NCT00802945|Secondary|Kaplan Meier Estimate of Progression-Free Survival (PFS)|"Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|Up to 2 years.||||Months||95% Confidence Interval|Median
1456717|NCT00802945|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years.||||percentage of subjects||95% Confidence Interval|Number
1456718|NCT00802919|Secondary|Change From Basellne in Calgary Depression Scale Score|The Calgary Depression Scale for Schizophrenia. The scale has 9 items with ratings of 0 to 3 on each item. Total score can vary from 0 to 27. Higher scores indicate more depression. Negative change scores indicate decreasing depression.|baseline, 4 weeks, 8 weeks|Not all patients had relevant responses on Calgary Depression Scale. Data are analyzed for 36 subjects randomized to varenicline and 38 subjects randomized to placebo (total N=74).|||Scores on a scale||Standard Error|Mean
1456719|NCT00802919|Secondary|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.|baseline, 4 weeks, 8 weeks||||units on a scale||Standard Error|Mean
1456720|NCT00802919|Primary|Change From Baseline in Cognitive Performance|The MATRICS Consensus Cognitive Battery (MCCB)(Measurement and Treatment Research to Improve Cognition in Schizophrenia) was used to measure cognitive performance. Six Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program (modified beta version) from raw scores on 10 individually administered subtests. The social cognition test was not assessed in this study. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.|basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks)|N's varied from 25-32 in varenicline group and 29-35 in placebo group because all subjects did not complete all parts of MATRICS battery.Maximum number of participants is entered for number of participants because this cell entry does not allow entry of variable number of participations ( e.g. 25-32). for different scores..|||T scores from MATRICS battery||Standard Error|Mean
1456721|NCT00802919|Primary|Cotinine Level|plasma cotinine|Baseline, 4 weeks, 8 weeks|Data were available for cotinine analysis in mixed model analysis of co covariance on 34 participants in the varenicline arms and 36 participants in the placebo arm.|||cotinine ng/ml||Standard Error|Mean
1456722|NCT00802893|Secondary|Evaluate the Efficacy of Oral 6R-BH4 Versus Dosage-equivalent Placebo to Improve Endothelia Function, to Reduce SBP, to Reduce Arterial Stiffness||4-8 weeks|Due to difficulties recruiting, this study was terminated and no data was collected.||||||
1456723|NCT00802893|Primary|Evaluate the Efficacy of 6R-BH4 Versus Placebo to Improve Endothelia Function||4-6 weeks|Due to difficulties recruiting, this study was terminated and no data was collected.||||||
1456724|NCT00802880|Secondary|Correlate Overall Survival With Best Metabolic Response||Completion of follow-up (estimated to be 1 year)|28 patients were not evaluable for this outcome measure due to various reason such as progressive disease prior to cycle 3, unknown survival status, no target lesion on PET scan, and toxicity.|||months||95% Confidence Interval|Median
1456725|NCT00802880|Secondary|Correlate Overall Survival With Best Anatomic Response||Completion of follow-up (estimated to be 1 year)|26 patients were not evaluable for this outcome measure for various reasons including unknown survival status, progressive disease prior to cycle 3, no anatomic response noted, and toxicity.|||months||95% Confidence Interval|Median
1457106|NCT00799383|Primary|Total Body Bone Mineral Content|Outcomes were measured at baseline, 18 weeks, and 36 weeks later.|36 weeks|Numbers below reflect attrition.|||Z score (age-sex-height-race specific)||Standard Deviation|Mean
1456726|NCT00802880|Secondary|Correlate Time to Progression With Best Metabolic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.|||months||95% Confidence Interval|Median
1456727|NCT00802880|Secondary|Correlate the Time to Progression With Best Anatomic Response|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Completion of follow-up (estimated to be 1 year)|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no anatomic response recorded.|||months||95% Confidence Interval|Median
1456728|NCT00802880|Secondary|Overall Survival||Until completion of follow-up or patient death (estimated to be 1 year)|One patient with invalid time or censoring value was not included.|||months||95% Confidence Interval|Median
1456729|NCT00802880|Secondary|Time to Progression (TTP)|-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Until completion of follow-up (estimated to be 1 year)|10 patient observations with invalid time or censoring values were not included.|||months||95% Confidence Interval|Median
1456730|NCT00802880|Secondary|Overall Disease Control Rate||12 months|Only 6 patients were evaluable for response at the end of 12 cycles.|||participants|||Number
1456731|NCT00802880|Secondary|Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate||After completion of 3 cycles|31 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.|||participants|||Number
1456732|NCT00802880|Secondary|Overall Tumor Metabolic Response|"Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions.~Partial metabolic response (PMR)~Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.~Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within >50% of the lesions. No unequivocal new lesions.~Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD.~Progressive metabolic disease (PMD):~Unequivocal development of one more new metabolically active lesions~Target lesion: 20% or greater increase in maximum SUV from baseline.~Non-target lesions: unequivocal increase in FDG activity"|After completion of 3 cycles|29 patients were not evaluable due to various reasons such as toxicity, progressive disease prior to completion of cycle 3, patient refusal, and no target lesions on PET scan.|||participants|||Number
1456733|NCT00802880|Secondary|Comparison of the SUV at up to 3 Tumor Sites||Baseline and after every three cycles of treatment (up to 1 year)|The lower confidence limit is 85% and the upper confidence limit is 95%. 51 patients evaluable at baseline, 50 patients evaluable at end of cycle 3, 20 patients evaluable at end of cycle 6, 7 patients evaluable at end of cycle 9, and 5 patients evaluable at end of cycle 12.|||standard uptake value||95% Confidence Interval|Mean
1456734|NCT00802880|Secondary|Rate of Nausea/Emesis (Any Grade)|Approximately 18 weeks|Completion of 6 cycles of treatment (18 weeks)||||percentage of participants|||Number
1456735|NCT00802880|Secondary|Rate of Neutropenia (Grade 3/4)|"Grade 3 neutropenia = absolute neutrophil count of <1000 – 500/mm^3~Grade 4 neutropenia = absolute neutrophil count of <500/mm^3"|Completion of 6 cycles of treatment (18 weeks)||||percentage of participants|||Number
1456736|NCT00802880|Primary|Best Anatomical Tumor Response|"Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker~Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal~Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal~Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions"|After completion of 3 cycles|3 patients failed to complete 3 cycles of treatment due to toxicity. 22 patients failed to complete 3 cycles of treatment due to progressive disease. 1 patient only had PET scan.|||participants|||Number
1456737|NCT00802867|Primary|Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®|"Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.~Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash."|0 to 3 days post-dose 5 vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population.|||Percentage of Participants|||Number
1456738|NCT00802867|Other Pre-specified|Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose||Pre-dose 5 and Day 28 to 48 Post-dose 5|The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.|||Titers||95% Confidence Interval|Geometric Mean
1456739|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose|Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination|Day 28 to 48 Post-dose 5|The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.|||Percentage of Participants|||Number
1457552|NCT00795951|Primary|Diagnostic Performance: Paraben Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456740|NCT00802867|Other Pre-specified|Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose|Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5.|Day 28 to 48 Post-dose 5|The anti-Pertussis Booster response was evaluated in a subset of the per-protocol population for immunogenicity.|||Percentage of participants|||Number
1456741|NCT00802867|Other Pre-specified|Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.|"Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).~Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer."|Day 28 to 48 Post-dose 5|The vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity.|||Percentage of Participants|||Number
1456742|NCT00802854|Primary|Number of Participants With Overall Response (OR)|OR: final effectiveness evaluation analyzed using following criteria (based on physician’s evaluation of CR & MR): a)Effective:clinical success (cure/improvement) & microbiological success (eradication/presumed eradication), b)Ineffective:clinical failure/microbiological failure (persistence/presumed persistence); c)Unevaluable:unevaluable CR & MR & neither response was failure. CR:cure (resolutions of symptom), improvement (significant but incomplete resolution of sign/symptom), failure (no significant improvement/death), Unevaluable:no evaluation as participant withdrew prior assessment of cure/failure/lost to follow-up. MR:eradication (baseline pathogen not isolated from original site culture); presumed eradication(culture data not exist & CR of cure/improvement); persistence (baseline Candida species present in repeat culture); presumed persistence (culture data not exist;CR defined as failure), unevaluable:culture data not exist, superinfection:emergence of new Candida infection.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.|||participants|||Number
1456743|NCT00802854|Primary|Number of Participants With Mycological Response (MR)|In case cultivation was performed, isolated pathogens before and after administration of Eraxis were recorded and MR outcomes after Eraxis administration were evaluated. MR was evaluated as: a) Eradication: baseline pathogen not isolated from original site culture; b) Presumed eradication: culture data did not exist and CR was defined as cure(resolution of signs and symptoms attributed to Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection); c) Persistence: any baseline Candida species was present in repeat culture; d) Presumed persistence: culture data did not exist and CR was defined as failure (no significant improvement in signs and symptoms of Candida infection, or death due to Candida infection); e) Unevaluable: when culture data did not exist; and f) Superinfection: emergence of new Candida infection at original site of infection or at distant infection site.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.|||participants|||Number
1456744|NCT00802854|Primary|Number of Participants With Clinical Response (CR)|CR was categorized as: a) Cure: resolution of signs and symptoms attributed to Candida infection; b) Improvement: significant, but incomplete resolution of signs and symptoms of the Candida infection c) Failure: no significant improvement in signs and symptoms of Candida infection, or death due to the Candida infection; d) Unevaluable: evaluation was not made due to withdrawal of participant from the study prior to assessment of cure or failure, or when lost to follow-up.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Effectiveness analysis set included participants who had been administered Eraxis IV 100 mg at least once and evaluated upon its related effectiveness endpoints at least once.|||participants|||Number
1456745|NCT00802854|Primary|Number of Participants With Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein). Laboratory abnormalities were identified by the Investigator.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|"Safety analysis set included all participants who received at least 1 dose of Eraxis. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
1456746|NCT00802854|Primary|Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness of AE to treatment was assessed by physician as: Certain (had clinically reasonable reaction on cessation of the treatment); Probable/likely (followed a reasonable time sequence from administration of treatment which was not explained by other drugs, chemical substance or accompanying diseases); Possible (followed a reasonable time sequence from administration of treatment); Unlikely (not likely to have a reasonable causal relationship with treatment, seems temporary); Conditional/unclassified (needed more data to make an appropriate assessment or its additional data were being reviewed); Unaccessible/unclassifiable (lack of sufficient information hampered accurate causality assessment).|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||percentage of AEs|||Number
1456747|NCT00802854|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: ‘Is the adverse event still present?’ as ‘yes’, ‘unknown’ or ‘no-resolved'.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Subset of safety analysis set which included all participants who had at least 1 AE.|||participants|||Number
1457487|NCT00796523|Secondary|Parenting Stress Index|a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.|week 6|results based on ITT; 16 subjects did not complete any diaries or data collection instruments and are not included in the analysis|||points on a scale||Standard Deviation|Mean
1456748|NCT00802854|Primary|Number of Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild – AEs does not interfere with participant’s usual function b) moderate – AEs interferes to some extent with participant’s usual function c) severe – AEs interferes significantly with participant’s usual function.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||events|||Number
1456749|NCT00802854|Primary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time (in days) from onset of adverse event till the event is resolved in participants who had at least 1 AE.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Subset of safety analysis set which included all participants who had at least 1 AE.|||days||Standard Deviation|Mean
1456750|NCT00802854|Primary|Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||participants|||Number
1456751|NCT00802854|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|From the time of first dosing of Eraxis until 28 calendar days after last dose of Eraxis|Safety analysis set included all participants who received at least 1 dose of Eraxis.|||participants|||Number
1456752|NCT00802841|Secondary|Overall Survival (OS)|OS was defined as time from date of randomization to the date of the death.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
1456753|NCT00802841|Secondary|Event-Free Survival (EFS)|EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
1456754|NCT00802841|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
1456755|NCT00802841|Secondary|Duration of CCyR|Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
1456756|NCT00802841|Secondary|Time to CCyR|Time to CCyR was defined as time from date of randomization to date of first documented CCyR.|24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Months||95% Confidence Interval|Median
1456757|NCT00802841|Secondary|Percentage of Participants With CCyr|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Percentage of participants|||Number
1456758|NCT00802841|Secondary|Percentage of Participants With Major Molecular Response (MMR)|MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS).|12 and 24 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Percentage of participants|||Number
1456759|NCT00802841|Primary|Percentage of Participants With Complete Cytogenetic Response (CCyR)|CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.|6 months|Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.|||Percentage of participants|||Number
1456760|NCT00802737|Secondary|Cmax and Ctrough at Visit 2 (Week 0) and at Visit 14 (Month 4)|Cmax is defined as the maximum concentration of drug in plasma samples (collected at the end of the infusion). Ctrough is defined as the concentration of drug in plasma samples at the end of a dosing interval (collected directly before next administration). Ctrough before the first infusion represents residual ofatumumab from participation in Study Hx-CD20-406.|Visit 2 (Week 0) and Visit 14 (Month 4)|FAS. Data are provided for the number of participants attending each visit. Participants withdrawn during the study were not analyzed.|||Milligrams per liter (mg/L)||95% Confidence Interval|Geometric Mean
1456761|NCT00802737|Secondary|Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics|The data collected for this analysis are reported in the overall SAEs of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS||||||
1456762|NCT00802737|Secondary|Number of Participants With the Indicated Major Infections|The data collected for this analysis are reported in the overall Serious Adverse Events (SAEs) of infections rather than reported separately for this specific analysis. This is a conservative approach for reporting all infectious SAEs in order to ensure that all of the infectious SAEs are represented.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS||||||
1456763|NCT00802737|Secondary|Number of Participants Who Experienced Any Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section of this results record.|From the first infusion (Visit 2/Week 0) until the last visit of the Extended Follow-up Phase (up to Study Month 26 [visit 34])|FAS|||participants|||Number
1456764|NCT00802737|Secondary|Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of Screening and Post Ofatumumab|HAHAs are indicators of immunogenicity to ofatumumab. HAHA levels were assessed for each participant at the end of participation in the study (at their last visit). A positive HAHA status indicates a positive enzyme-linked immunosorbent assay (ELISA) result, an inconclusive status indicates a negative ELISA result at ofatumumab concentration above the threshold at which ofatumumab may interfere with the assay, and a negative status indicates a negative ELISA result at ofatumumab concentration below the threshold.|Screening and post ofatumumab (up to Study Month 32)|"FAS. During the study, samples were to be taken at the last visit; however, this may not have been possible, such as in cases of death, or when the visit was not obvious as the last visit. Therefore, some samples were not available or were not collected."|||participants|||Number
1456765|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 24|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 24. Percent change was calculated as (Month 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 24|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 24. Only participants with a baseline value and a post-baseline value at Month 24 were included in the calculation.|||Percent change in tumor size||Full Range|Median
1456766|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 12|Reduction in tumor size was measured by the percentage change in the sum of products of the diameters of the largest abnormal lymph nodes from Baseline to Month 12. Percent change was calculated as (Month 12 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 12|FAS. No participants in the 2000 mg Ofatumumab + Other treatment arm were able to contribute to this measure. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 12. Only participants with a baseline value and a post-baseline value at Month 12 were included in the calculation.|||Percent change in tumor size||Full Range|Median
1456767|NCT00802737|Secondary|Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Month 4|Reduction in tumor size was measured as the percent change in the sum of the products of the diameters of the largest abnormal lymph nodes from Baseline to Week 24. Percent change was calculated as (Week 24 SPD minus Baseline SPD)/Baseline SPD * 100.|Baseline (Visit 2) and Month 4|FAS. Measurement of tumor size was completed by physical examination for participants remaining in the study at Month 4. Only participants with a baseline value and a post-baseline value at Month 4 were included in the calculation.|||Percent change in tumor size||Full Range|Median
1456768|NCT00802737|Secondary|Overall Survival (OS)|OS is defined as the time from allocation to death.|Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months)|FAS|||months||95% Confidence Interval|Median
1456769|NCT00802737|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment|Time to next chronic lymphocytic leukemia (CLL) treatment is defined as the time from treatment allocation/randomization (Visit 2) until the time of the first administration of the next CLL treatment other than ofatumumab (or HuMaxCD20, a fully human monoclonal antibody to CD20 that is expressed on the surface of B-cells).|Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (average of 14.8 study months)|FAS|||months||95% Confidence Interval|Median
1456770|NCT00802737|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until progression (prog.)/death. Prog. events are defined by well-documented and verifiable data; other data are censored. If the par. had prog. between scheduled visits, died before the first assessment, or died between adequate visits, the endpoint was considered progressed. If there was no prog. at the end of the trial, treatment discontinuation for undocumented prog./toxicity/other reason, new anti-cancer treatment, and death/prog. after >=2 missed visits in a row, the endpoint was censored. Clinical prog. is not considered as a prog. endpoint.|Start of treatment (Week 0 of Visit 2) until progression or death (average of 14.1 study months)|FAS|||months||95% Confidence Interval|Median
1456771|NCT00802737|Secondary|Duration of Response|Duration of response is defined as the time from the initial response (first visit at which response is observed) to progression or death. If the participant had progression between scheduled visits, no progression at the end of the trial, treatment discontinuation for undocumented progression, treatment discontinuation for toxicity or other reason, new anti-cancer treatment, and experienced death or progression after two or more missed visits in a row the endpoint was censored.|From the time of the initial response until progression or death (average of 14.1 study months)|FAS|||months||95% Confidence Interval|Median
1456772|NCT00802737|Primary|Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines|Par. with complete remission (CR), nodular partial remission (nPR), and partial remission (PR) on 2 consecutive visits >=56 days apart were classified as Rs; those with stable disease (SD)/progressive disease (PD) were classified as NRs. Per the NCIWG 1996 guidelines: CR; no lymphadenopathy/hepatomegaly/splenomegaly/constitutional symptoms, normal hematology, normocellular bone marrow sample for age, <30% lymphocytes (LC), no lymphoid nodule; PR: >=50% decrease in LC/lymphadenopathy; nPR: persistent bone marrow nodules; PD: new lesion or increase by >=50% from baseline; SD: no CR, PR, or PD.|Start of treatment (Week 0/Visit 2) until Week 52|Full Analysis Set (FAS): all participants who had been exposed to study drug irrespective of their compliance to the planned course of treatment. Some participants were not evaluable (NE) due to participant withdraw, refusal, non-trial drug-related adverse events, and death.|||participants|||Number
1456773|NCT00802685|Secondary|Number of Participants on Oxygen at 36 Weeks Postmenstrual Age||at 36 weeks postmenstrual age||||participants|||Number
1456775|NCT00802672|Secondary|Proportion of Subjects With Clinical Cure|Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject’s current episode of tinea pedis|6 weeks|per protocol population|||participants|||Number
1456776|NCT00802672|Secondary|Proportion of Subjects With Mycological Cure|Mycological Cure (KOH wet mount negative and fungal culture negative|6 weeks|per protocol population|||participants|||Number
1456777|NCT00802672|Primary|Proportion of Subjects in Each Treatment Group With Therapeutic Success|Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success|6 weeks|Per protocol population|||participants|||Number
1456778|NCT00802659|Secondary|Quality of Life|"As measured by the Functional Assessment of Cancer Therapy - Central Nervous System (FACT-CNS)~Participant can chose on a scale of 0-4 with 0=not at all and 4=very much."|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
1456779|NCT00802659|Secondary|Determine the Pattern of Failure After Stereotactic Irradiation of Spinal Metastases.||4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
1456780|NCT00802659|Secondary|Determine the Rate of Radiation-induced Myelopathy From Stereotactic Re-irradiation of the Spinal Metastases.||4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
1456781|NCT00802659|Secondary|Duration of Pain Control for Each Dose Level.|A reduction in pain, referable to the site of the spine lesion, by >=30% according to the Brief Pain Inventory (BPI), or a smaller decrease in pain accompanied by a reduction of pain medications.|4 years|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
1456782|NCT00802659|Primary|Optimal Dose of Stereotactic Spinal Irradiation Needed to Obtain Durable Pain Control at 4 Weeks in a Previously Irradiated Spine Field|"Optimal dose~the maximum tolerated dose (MTD) that will result in a 10% ESRT-induced neurological complications~the minimal dose level that can achieve an 80% or more pain control rate, whichever occurs first"|4 weeks|Group 1 was the only group to have a participant enrolled; however this outcome was not measured because there was not enough participants enrolled to provide the needed data for analysis.||||||
1456783|NCT00802633|Secondary|Operating Room Time in Minutes||Intraoperative time||||minutes||Standard Deviation|Mean
1456784|NCT00802633|Primary|Estimated Blood Loss||Perioperative||||milliliters||Standard Deviation|Mean
1456785|NCT00802529|Secondary|Change in Speech Discrimination|"Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.~Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear – bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear – 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score."|Baseline, 1,2,6,12 and 24months after initial treatment||||Percentage correct||Standard Deviation|Mean
1456786|NCT00802529|Secondary|Change in Hearing|Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.|Baseline, 1,2,6,12,18 and 24months after initial treatment||||dB||Standard Deviation|Mean
1456787|NCT00802529|Primary|Vertigo Attacks|The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).|6month pre-enrollment baseline, 18-24 months after initial treatment|Intention-to-treat|||Vertigo Attacks||Standard Deviation|Mean
1456788|NCT00802503|Secondary|Days in Hospital|hospital length of stay|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||days in hospital||95% Confidence Interval|Mean
1456789|NCT00802503|Secondary|Protein Delivery During the Intervention Period From Day 4 to Day 8|Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||percentage of protein target||Standard Deviation|Mean
1456790|NCT00802503|Secondary|ICU Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||participants|||Number
1456791|NCT00802503|Secondary|Days in ICU|Days in ICU|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||days in ICU||95% Confidence Interval|Mean
1456792|NCT00802503|Secondary|General Mortality||28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||participants|||Number
1457553|NCT00795951|Primary|Diagnostic Performance: Colophony|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456793|NCT00802503|Secondary|Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.|Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.|5 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||% of energy target||Standard Deviation|Mean
1456794|NCT00802503|Secondary|Antibiotic Free Days|Number of days between day 9 to day 28 (follow-up period) free of antibiotics|20 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||number of days||95% Confidence Interval|Mean
1456795|NCT00802503|Secondary|Hours on Mechanical Ventilation in All Patients|Mechanical ventilation hours during study duration (days 1-28)|28 days|The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).|||hours of mechanical ventilation||95% Confidence Interval|Mean
1456796|NCT00802503|Primary|Documented Infection Rate|Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28|20 days||||Infections|||Number
1456797|NCT00802464|Secondary|Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 3|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1456798|NCT00802464|Secondary|Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 2|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1456799|NCT00802464|Secondary|Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges|Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Mean Corpuscular Volume (MCV), Monocytes (MON), Neutrophils (NEU), Partial Thromboplastin Time (PTT), Platelets (PLAT), Prothrombin Time (PT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).|At Month 0|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1456800|NCT00802464|Secondary|Number of Subjects With Suspected Cases of Herpes Zoster (HZ)|A suspected case of HZ is defined as a rash consistent with HZ.|During the period after Month 8 up to the end of the study at Month 14|The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.|||Participants|||Count of Participants
1456801|NCT00802464|Secondary|Number of Subjects With Suspected Cases of Herpes Zoster (HZ)|A suspected case of HZ was defined as a rash consistent with HZ.|From Month 0 until Month 8|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1456802|NCT00802464|Secondary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)|Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|During the period after Month 8 up to the end of the study at Month 14|The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.|||Participants|||Count of Participants
1456803|NCT00802464|Secondary|Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)|Any new onset of autoimmune diseases were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.|From Month 0 until Month 8|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1457554|NCT00795951|Primary|Diagnostic Performance: Fragrance Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456804|NCT00802464|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the period after Month 8 up to the end of the study at Month 14|The analyses were performed on the Total Vaccinated Cohort for the Safety Follow-up (SFU) Month 14, which included all vaccinated subjects who were not withdrawn from the study during the period up to Month 3 nor from the SFU Month 8, and who signed the supplementary informed consent for participating to the End of study telephone contact.|||Participants|||Count of Participants
1456805|NCT00802464|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 up to Month 8|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1456806|NCT00802464|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1456807|NCT00802464|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6)post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1456808|NCT00802464|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period after each dose and across doses|The analyses were performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
1456809|NCT00802464|Secondary|Anti-VZV Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1456810|NCT00802464|Secondary|Anti-gE Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1456811|NCT00802464|Secondary|Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||VZV-specific CD4+ T-cells/million T-cell||Standard Deviation|Mean
1456812|NCT00802464|Secondary|Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|At Month 0 and at Month 2|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
1456813|NCT00802464|Primary|Anti-VZV Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1456814|NCT00802464|Primary|Anti-glycoprotein E (gE) Antibody Concentrations|Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1456815|NCT00802464|Primary|Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||VZV-specific CD4+ T-cells/million T-cell||Standard Deviation|Mean
1456816|NCT00802464|Primary|Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers|The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).|One month after the second vaccination (Month 3)|The analyses were performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects from Month 0 to 3. This included those subjects who met all eligibility criteria, complied with the protocol, with no elimination criteria during this part of the study and for whom immunogenicity measures were available.|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
1456817|NCT00802438|Secondary|Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab|IL-5 was measured via ELISA on bronchoalveolar lavage fluid before and after mepolizumab administration (up to 3 months of administration). Fluid was prepared in LowCross-Buffer to minimize potential matrix effects. A 1/2 dilution of 1X bronchoalveolar fluid was used for IL-5 detection. Data are expressed as pg/mL and are extrapolated to 1X.|before and after up to 3 months of Mepo|Participants had mild allergic asthma with a positive skin-prick test to house dust mite, ragweed, or a standardized extract of cat, a pre-180 4g albuterol FEV1 ≥70%, a post-albuterol FEV1 ≥ 80%; airway reversibility to albuterol (180 4g) ≥12% and/or airway hyper-reactivity to methacholine (PC20 ≤8 mg/ml).|||pg/ml||Inter-Quartile Range|Median
1456818|NCT00802438|Primary|The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4).|Percent of eosinophils was determined in the bronchoalveolar lavage fluid collected from the participant after segmental allergen challenge. This was done via differential cell count using Hema-3 stain. Cell differentials were determined by counting a total of 1000 cells on two cytospin preparations. The percent eosinophils were done before and after administration of mepolizumab for a specified amount of time (up to 3 months of administration).|before and after up to 3 months of Mepo.|Participants had mild allergic asthma with a positive skin-prick test to house dust mite, ragweed, or a standardized extract of cat, a pre-180 4g albuterol FEV1 ≥70%, a post-albuterol FEV1 ≥ 80%; airway reversibility to albuterol (180 4g) ≥12% and/or airway hyper-reactivity to methacholine (PC20 ≤8 mg/ml).|||percent of bronchoalveolar eosinophils||Inter-Quartile Range|Median
1456819|NCT00802412|Secondary|Percent Relapsing to Any Drinking or Illicit Drug Use|Alcohol or illicit drug use during treatment or follow up.|12-week treatment phase, 36-week combined treatment and follow-up||||percentage of participants|||Number
1456820|NCT00802412|Primary|4-week Continuous Abstinence From Smoking|This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.|Weeks 8-12 of treatment.||||percentage of participants abstinent|||Number
1456821|NCT00802360|Secondary|Number of Live Births||Approximately 10 months|Database was locked prior to all participants giving birth.|||live births|||Number
1456822|NCT00802360|Secondary|Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|"Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:~mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable)~Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.~Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly."|Day 1 - week 12|Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study|||participants|||Number
1456823|NCT00802360|Secondary|Participants With Clinical Pregnancy at Week 7|Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.|approximately week 7|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer|||participants|||Number
1456824|NCT00802360|Secondary|Participants With Biochemical Pregnancy at Day 38|Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.|approximately day 38 (Day 14 post embryo transfer)|Intent-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had an embryo transfer|||participants|||Number
1456825|NCT00802360|Primary|Percentage of Participants With Ongoing Pregnancy at Week 8|The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.|Week 8 (Week 6 of gestation)|Intent to treat population|||percentage of participants|||Number
1457555|NCT00795951|Primary|Diagnostic Performance: Caine Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456826|NCT00802360|Secondary|Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle|A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).|Day 1 to Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||participants|||Number
1456827|NCT00802360|Secondary|Number of Embryos Frozen at Day 24|The number of embryos that were not transferred but instead were frozen for future use.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes fertilized|||embryos||Standard Deviation|Mean
1456828|NCT00802360|Secondary|Number of Embryos Transferred at Three Stages of Development|The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.|Approximately Day 24|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had embryos transferred.|||embryos||Standard Deviation|Mean
1456829|NCT00802360|Secondary|Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved|The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.|Approximately Day 19|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.|||proportion of oocytes retrieved||Standard Deviation|Mean
1456830|NCT00802360|Secondary|Number of Oocytes Retrieved at Day 18|The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.|Approximately Day 18|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication and had oocytes retrieved.|||oocytes||Standard Deviation|Mean
1456831|NCT00802360|Secondary|Number of Follicles Observed at Day 15|The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.|Day 15|Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication|||follicles||Standard Deviation|Mean
1456832|NCT00802204|Secondary|Binge Eating Score Questionnaire|Increased scores indicate increased binge eating behaviors. Score 0-46|Baseline||||score from questionnaire||Standard Deviation|Mean
1456833|NCT00802204|Primary|Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI)|Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the minimal model method|Baseline to post 8-10days after VLCD|"9 lean enroll but only 8 complete. A ll lean complete study after baseline outcome measurements.~19 obese enroll but only 18 complete baseline studies and of these 15 completed the VLCD"|||10-4*min-1*microU-1*mL||Standard Deviation|Mean
1456834|NCT00802204|Primary|Acyl Ghrelin||Baseline to post 8-10days after VLCD||||pg/ml||Standard Deviation|Mean
1456835|NCT00802204|Primary|Leptin||Baseline to post 8-10days after VLCD||||ng/ml||Standard Deviation|Mean
1456836|NCT00802204|Primary|Glucose||Baseline to post 8-10days after VLCD||||mg/dL||Standard Deviation|Mean
1456837|NCT00802204|Primary|Insulin|microU/ml|Baseline to post 8-10days after VLCD||||microU/ml||Standard Deviation|Mean
1456838|NCT00802204|Primary|Striatal DRD2 Receptor Binding|Region of interest compared to reference region to calculate binding potential|Baseline and after 8-10days VLCD|Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD|||ratio||Standard Deviation|Mean
1456839|NCT00802178|Secondary|Global Clinical Assessments of Efficacy of Mirapexin® for All Patients|Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.|4 - 8 weeks|Treated set (TS)|||Number of Participants|||Number
1456840|NCT00802178|Secondary|Change From Baseline in UPDRS Part III|Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).|Baseline and 4 - 8 weeks|Full Analysis set (FAS)|||Unit on a scale|||Number
1456841|NCT00802178|Secondary|Change From Baseline in UPDRS (Unified Parkinson’s Disease Rating Scale) Part I|Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)|Baseline and 4 to 8 weeks|Full Analysis set (FAS)|||Unit on a scale|||Number
1456842|NCT00802178|Primary|Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated|"Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as “good” on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.~De-novo patients were identified by:~those who were referred: - if ‘Reason for Referral’ = ‘initiation of therapy’ or for ‘diagnostic reason’ and for those not referred: - if initial pharmacotherapy = ‘Mirapexin® monotherapy’ (i.e., no other anti Parkinson Disease (PD) therapy)"|4 - 8 weeks|Full Analysis set (FAS) of De-novo patients in whom monotherapy with Mirapexin® could be successfully initiated|||Participants|||Number
1456843|NCT00802100|Secondary|Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment||Measured over 28 weeks of study visits|Analysis population is those randomized. Outcome is discontinuation from study treatment before 28 weeks|||participants|||Number
1456844|NCT00802100|Primary|Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study|Goal was to randomize 60 participants who met eligibility criteria.|Baseline|Total study population|||participants|||Number
1456867|NCT00801632|Secondary|Time to Neutrophil Recovery Following Transplant|Time (in days) until neutrophil recovery following transplant. Neutrophil recovery is defined as an absolute neutrophil count (ANC) > 500/mm^3 at three consecutive assessments on different days post-transplant. Time to recovery is time from transplantation until the first assessment date used to confirm the recovery.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat|||days||Standard Deviation|Mean
1456868|NCT00801632|Secondary|Percentage of Participants Surviving Through 156 Weeks|The percentage of participants who survived from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced death prior to week 156|||Percentage of Participants||95% Confidence Interval|Number
1456845|NCT00802074|Primary|CL/F: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||L/h||90% Confidence Interval|Mean
1456846|NCT00802074|Primary|AUC: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng*h/mL||90% Confidence Interval|Mean
1456847|NCT00802074|Primary|Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng/mL||90% Confidence Interval|Mean
1456848|NCT00802074|Primary|CL/F: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||L/h||90% Confidence Interval|Mean
1456849|NCT00802074|Secondary|Number of Participants Who Experienced Adverse Events|"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare AE's for each sequence and not for each regimen. 3The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004)."|Day 0 through Day 49||||participants|||Number
1456850|NCT00802074|Primary|AUC: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng•h/mL||90% Confidence Interval|Mean
1457556|NCT00795951|Primary|Diagnostic Performance: Potassium Dichromate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1456851|NCT00802074|Primary|Cmin/Cmax: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens||||ng/mL||90% Confidence Interval|Mean
1456852|NCT00801983|Primary|Musculoskeletal Discomfort|"Discomfort Survey (WDS) was used to assess symptoms and activity limitations. Participants reported on their work schedule, medication used for pain control, and discomfort in their neck/shoulder, back, and bilateral lower arms (elbows, forearms, wrists, and hands) using an 11-point numerical rating scale (0 = no discomfort/no limitations; 10 = unbearable discomfort/major limitations).~We had to dichotomize the data during analysis due to severe skew towards not discomfort (0). Thus the final outcome was discomfort -yes or no"|6 months and 12 months||||percentage of subjects with MSD|||Number
1456853|NCT00801892|Secondary|Fatigue/Inertia|Fatigue/Inertia from the Profile of Moods Subscale; scores range from 0 to 28; higher scores indicate more fatigue/inertia|after one month||||units on a scale||Standard Deviation|Mean
1456854|NCT00801892|Secondary|Change in Vigor-Activity During Main Study Period|Vigor-Activity from Profiles of Mood Scale; scores range from 0 to 32 with higher scores indicating higher vigor/activity|after one month||||units on a scale||Standard Deviation|Mean
1456855|NCT00801892|Secondary|Change in Daytime Sleepiness During Main Study Period|Daytime Sleepiness measured by the Epworth Sleepiness Scale; measured from 0 to 24; higher scores indicate worse sleepiness|after one month||||units on a scale||Standard Deviation|Mean
1456856|NCT00801892|Secondary|Change in Sleep Quality|From Pittsburgh Sleep Quality Index; scores range from 0 to 21 with higher scores worse sleep quality; data from main study period|after one month||||units on a scale||Standard Deviation|Mean
1456857|NCT00801892|Secondary|Fructosamine|Change in fructosamine level from baseline to one month: data from main study period|after one-month||||umol/L||Standard Deviation|Mean
1456858|NCT00801892|Primary|Physical Activity, Steps Walked|Steps walked measured by the Bodymedia SenseWear Pro Armband®Data collected from the main study period|after one-month treatment||||steps walked||Standard Deviation|Mean
1456859|NCT00801827|Primary|Regional DRD2/3 Binding Percent Changes After Bariatric Surgery||~7 weeks||||percentage of binding potential change||Standard Deviation|Mean
1456860|NCT00801801|Secondary|Response Rate in Poor Performance Status Subjects|To assess response rate and tumor control rate (complete remission + partial remission + stable disease) in poor performance status (PS =2) patients with advanced or metastatic (Stage IIIB – pleural effusion/IV) non-squamous cell-NSCLC treated with metronomic chemotherapy plus sorafenib. The objective response was defined as a percentage of those patients that had 30% or more of tumor regression at any time during treatment. Tumor control rate include the percentage of those patients that have less than 20% increase in the target tumor parameters during treatment (stable disease + partial response + complete response).|6 months||||participants|||Number
1456861|NCT00801801|Primary|2-month Progression-free Survival Rate|Evaluation of the 2-month progression-free survival in poor performance status patients with non-squamous non-small cell lung cancer with the goal to improve 2-month progression free survival from 50% to 70%. The 2-month progression free survival is determined after 8 weeks on treatment. Those patients that had less than 20% increase in the tumor target lesions are considered as progression free survival. The primary endpoint is the percentage of patients that are progression free in 2 months.|Baseline to 2 months|As the study did not accrue the maximum sample size for statistical analysis, none were done.|||participants|||Number
1456862|NCT00801684|Secondary|Time to Maximum Plasma Concentration (Tmax) of Trospium After Single Administrations of TrIP|Tmax is reported as median (range) of hours to reach maximum trospium concentration in plasma.|up to 24 hours post-treatment|The PK population consisted of all subjects who received active study medication and had sufficient concentration data to facilitate calculation of the PK parameters or descriptive statistics of concentrations of trospium.|||Hours||Full Range|Median
1456863|NCT00801684|Secondary|FEV1 Response to Treatment|Response was defined as the number of subjects reporting a post-treatment FEV1 of ≥12% (or 200 mL) above baseline.|Up to 24 hours post-treatment|All 24 randomized subjects were included in the analysis.|||Participants|||Number
1456864|NCT00801684|Primary|Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L)|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose."|15 minutes to 24 hours post-treatment||||Liters||Standard Deviation|Mean
1456865|NCT00801632|Secondary|Percentage of Participants Experiencing a Clinically Significant Invasive or Resistant Opportunistic Infection|Clinically significant invasive or resistant opportunistic infections include cytomegalovirus, herpes zoster, and candida.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat|||Percentage of Participants||95% Confidence Interval|Number
1456866|NCT00801632|Secondary|Time to Platelet Recovery Following Transplant|Time (in days) until platelet recovery following transplant. Platelet recovery is defined as a platelet count >20,000 /mm^3 and where no transfusion is required. Time to recovery is time from transplantation until platelet value recovers.|Transplantation until study completion or participant termination (participants followed up to five years)|Intent-to-treat|||days||Standard Deviation|Mean
1456869|NCT00801632|Secondary|Percentage of Participants With Graft Survival Through 156 Weeks|The percentage of participants with graft survival from transplantation through 156 weeks. Participants who terminated from the study prior to Week 156 without meeting the event were excluded. Graft survival is defined as the time to week 156 or graft loss. Graft loss is defined as the day on which a graft is deemed irreversibly nonfunctional and dialysis is begun, a transplantectomy is performed, or the participant is re-transplanted, whichever comes first. Six consecutive weeks of dialysis are required for the diagnosis of graft loss, though the date of graft loss will be defined as the date of first dialysis.|Transplantation until week 156|Participants who were followed at least three years after transplantation or experienced graft loss prior to week 156|||Percentage of Participants||95% Confidence Interval|Number
1456870|NCT00801632|Secondary|Change in Renal Function|Change in renal function as seen in serum creatinine values from baseline until study completion or participant termination. Baseline is defined as the lowest serum creatinine collected during stabilization period or in the four weeks following the end of the stabilization period. The stabilization period is defined as four consecutive creatinine values close in value (not differing more than 0.3 mg/dL). Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys.|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat|||mg/dL||Standard Deviation|Mean
1456871|NCT00801632|Secondary|Percentage of Participants Experiencing Acute Rejection|The percentage of participants who experience an acute rejection. Acute rejection is defined as a biopsy with findings of Banff score of grade IA or higher. The Banff classification is as follows: grade IA is >25% of parenchyma affected and foci of moderate tubulitis; Grade IB is >25% of parenchyma affected and foci of severe tubulitis; Grade IIA is mild to moderate intimal arteritis; Grade IIB is severe intimal arteritis comprising >25% of the luminal area; Grade III is “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.|Transplantation until study completion or participant termination (up to five years)|Intent-to-treat|||Percentage of Participants||95% Confidence Interval|Number
1456872|NCT00801632|Primary|Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks|A participant was considered a success if they were off immunosuppressive therapy for 104 consecutive weeks leading up to study week 208 (48 months post-transplant) or study termination, whichever occurred first.|48 months post-transplant|Intent-to-treat|||participants|||Number
1456873|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial. ULN=Upper limit of normal.|Up to 3 x 31 months|Safety Analysis Set.|||participants|||Number
1456874|NCT00801242|Secondary|Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight During One or More Cycles of Degarelix IAD Treatment|This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value during the trial.|Up to 3 x 31 months|Safety Analysis Set.|||participants|||Number
1456875|NCT00801242|Secondary|Sexual Function, as Assessed by the International Index of Erectile Function (IIEF) Scale, During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The IIEF scale addresses the relevant domains of male sexual function (i.e. erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction). The IIEF scale is psychometrically sound, and has been linguistically validated in multiple languages. The IIEF scale demonstrates the sensitivity and specificity for detecting treatment-related changes in patients with erectile dysfunction. It consists of the following domains (number of items per domain; ranges from x to y: erectile function (6; 1-30), orgasmic function (2; 0-10), sexual desire (2; 2-10), intercourse satisfaction (3; 0-15) and overall satisfaction (2; 2-10). For all domains, a higher score represents a better sexual function.|Up to 31 months|FAS, Cycle 1.|||units on a scale||Standard Deviation|Mean
1456876|NCT00801242|Secondary|Quality of Life, as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Module (EORTC QLQ-PR25), During the Induction Treatment and Off-treatment Periods During the First Cycle of IAD|The EORTC QLQ-PR25 employs a modular approach towards assessing cancer patients´ health-related Quality of Life (QoL) and assesses urinary, bowel, and sexual symptoms and functioning, and the side-effects of hormonal treatment. It consists of 25 questions distributed on six domains (number of items per domain, ranges from x to y: urinary symptoms (8, 0-100), bother due to use of incontinence aid (1, 0-100), bowel symptoms (4, 0-100), hormonal treatment-related symptoms (6, 0-100), sexual activity (2, 0-100), and sexual functioning (4, 0-100). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Up to 31 months|FAS, Cycle 1|||units on a scale||Standard Deviation|Mean
1456877|NCT00801242|Secondary|Number of Participants With Testosterone ≤0.5 ng/mL at the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.|||participants|||Number
1456878|NCT00801242|Secondary|Median and Between Participant Variability of Time to Return to Testosterone >0.5 ng/mL (Above Castration Level) During the First Cycle of IAD After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum testosterone levels were collected at the Screening Visit, Month 4 and 7 of the induction period of Cycle 1 and the corresponding visits of any additional treatment cycles, every two months during the off-treatment period(s), and at the End-of-Trial Visit. Analyses were performed using Liquid-Liquid Extraction and Liquid Chromatography-Mass Spectrometry/Mass Spectrometry.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1.|||days||95% Confidence Interval|Median
1456879|NCT00801242|Secondary|Percentage Change in PSA Serum Levels From Baseline to the Last Visit of the Induction Period During the First Cycle of IAD||7 months|FAS, Cycle 1.|||percentage of baseline||Standard Deviation|Mean
1456971|NCT00799773|Secondary|Treatment-related Complications||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456880|NCT00801242|Primary|Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment|Blood samples for analyses of serum PSA levels were collected at the Screening Visit, and every two months during the course of the trial, and at the End-of-Trial Visit. Analyses were performed using chemiluminometric immunoassay.|Up to 24 months after end of induction period|FAS, Off-treatment Cycle 1, i.e. a subset of all FAS participants who completed the 7 months' induction treatment period of the first cycle and were enrolled in the off-treatment period (of the first cycle) and had at least one efficacy assessment (i.e. PSA or testosterone determination) during the off-treatment period.|||days||95% Confidence Interval|Median
1456881|NCT00801229|Primary|"Participants Experiencing Collisions During Surprise Events in Driving Simulator"|"Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, surprise events, designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo."|6 weeks|Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total).|||participants|||Number
1456882|NCT00801138|Secondary|Total Three-day Opioid Consumption in Oral Oxycodone Equivalent||Postoperative day 1, 2 and 3||||milligrams||Inter-Quartile Range|Median
1456883|NCT00801138|Secondary|Median Maximum VAS Pain Scores at Rest|Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicates“no pain at all” and ten indicates “worst pain imaginable.” , The higher of the score, the worse of the pain.|Postoperative day 1, 2 and 3||||units on a scale||Inter-Quartile Range|Median
1456884|NCT00801138|Secondary|Time to First Report of Pain||Postoperative day 1, 2 and 3||||hours||Inter-Quartile Range|Median
1456885|NCT00801138|Primary|The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block||Postoperative day 1, 2 and 3||||hours||Inter-Quartile Range|Median
1456886|NCT00801099|Secondary|Sustainability of the Intervention in This Setting||during 3 month of study phase|||||||
1456887|NCT00801099|Primary|Number of Participants With Surgical Site Infections||within 30 days postoperative||||participants|||Number
1456888|NCT00800982|Primary|Psoriasis Area Severity Index. This Scale Ranges From 0-72, 0 Being no Disease, and 72 Being Most Severe. The Number of Patients Who Achieved 75% Improvement of Their Psoriasis at the End of 24 Weeks Are Indicated in the Outcomes Data Below.|Psoriasis area severity index was used to determine the number of patients in each treatment arm who had 75% improvement in their psoriasis. This scale uses the characteristics of the psoriasis, such as body surface area, redness, thickness, and scaling, to determine the severity score.|Weeks 12-24|All patients that completed the trial through week 24 were used for analysis.|||participants|||Number
1456889|NCT00800865|Primary|Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy|Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.|24, 32, and 48 hours post dose||||Ratio||90% Confidence Interval|Mean
1456890|NCT00800865|Primary|Level of Biomarkers|Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).|Baseline, 24, 32, and 48 hours post dose|Actual number of participants analyzed in Part I varied from 13 to 15, depending on time point. Actual number of participants analyzed in Part II was 16 for all time points.|||Percent pCDC2-positive cells||90% Confidence Interval|Geometric Mean
1456891|NCT00800839|Secondary|2-year Overall Survival|Overall Survival (OS) is defined as the interval between day of transplant and day of death.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years||||percentage of participants||95% Confidence Interval|Number
1456892|NCT00800839|Secondary|2-year Progression-Free Survival|Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.|First 25-35 days post transplant and then every 3 months for a maximum of 2 years||||percentage of participants||95% Confidence Interval|Number
1456893|NCT00800839|Secondary|Rate of Engraftment|Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.|From engraftment to 60 days post transplant||||days||Full Range|Median
1456894|NCT00800839|Primary|Day-100 Treatment-Related Mortality|Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.|100 days post transplant||||percentage of participants||95% Confidence Interval|Number
1456895|NCT00800839|Primary|Cumulative Incidence of Grade III to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant||||percentage of incidence||95% Confidence Interval|Number
1456896|NCT00800839|Primary|Cumulative Incidence of Grade II to IV Acute GVHD|Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.|100 days post transplant||||percentage of incidence||95% Confidence Interval|Number
1456897|NCT00800735|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event.|An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline through 24 weeks after the end of treatment (up to 72 weeks)|All enrolled patients.|||Percentage of participants|||Number
1456898|NCT00800683|Secondary|Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.|first administration of randomised treatment to ....|Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG|||participants|||Number
1456899|NCT00800683|Secondary|Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time|Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.|Baseline and Week 52|Treated Set|||Participants|||Number
1456900|NCT00800683|Secondary|FPG Change From Baseline at week52|This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 52|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456901|NCT00800683|Secondary|FPG Change From Baseline at Week 48|This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 48|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456902|NCT00800683|Secondary|FPG Change From Baseline at Week 42|This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 42|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456903|NCT00800683|Secondary|FPG Change From Baseline at Week 36|This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 36|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456904|NCT00800683|Secondary|FPG Change From Baseline at Week 30|This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 30|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456905|NCT00800683|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs|Baseline and Week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456906|NCT00800683|Secondary|FPG Change From Baseline at Week 18|Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456907|NCT00800683|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs|Baseline and Week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Least Squares Mean
1456908|NCT00800683|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 52|The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).|Baseline and Week 52|The Full Analysis Set (FAS) included all patients with a baseline and at least one on treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||Percentage of patients|||Number
1456909|NCT00800683|Secondary|The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=7.0%. Non-completers were considered as failure imputation (NCF).|||Percentage of patients|||Number
1456910|NCT00800683|Secondary|The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment|The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%|Baseline and Week 52|This population includes the FAS with baseline HbA1c>=6.5%. Non-completers were considered as failure imputation (NCF).|||Percentage of patients|||Number
1456911|NCT00800683|Secondary|HbA1c Change From Baseline at Week 48|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 48|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456912|NCT00800683|Secondary|HbA1c Change From Baseline at Week 42|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 42|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456913|NCT00800683|Secondary|HbA1c Change From Baseline at Week 36|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 36|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456914|NCT00800683|Secondary|HbA1c Change From Baseline at Week 30|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 30|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456915|NCT00800683|Secondary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 24|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456916|NCT00800683|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 18|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456917|NCT00800683|Secondary|HbA1c Change From Baseline at Week 52|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 52|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456918|NCT00800683|Primary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.|Baseline and Week 12|The Full Analysis Set (FAS) included all treated and randomised participants with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Least Squares Mean
1456919|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6|Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
1456920|NCT00800540|Secondary|Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6|Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Median
1456921|NCT00800540|Secondary|Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6|End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
1456922|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks|Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
1456923|NCT00800540|Secondary|Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6|Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||cm/s (centimeters per second)|Participants|Standard Error|Mean
1456924|NCT00800540|Secondary|Mean Change From Baseline in Systolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)||Standard Error|Mean
1456925|NCT00800540|Secondary|Mean Change From Baseline in Diastolic Blood Pressure at Week 6|Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)||Standard Error|Mean
1456926|NCT00800540|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6|Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
1456927|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||Arbitrary Units|Participants|Standard Error|Mean
1456928|NCT00800540|Secondary|Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6|Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.|||Arbitrary Units|Participants|Standard Error|Mean
1456929|NCT00800540|Secondary|Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6|Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression.|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
1456930|NCT00800540|Primary|Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6|Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 0, Week 6 (period-based)|This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).|||mmHg (millimeters of mercury)|Participants|Standard Error|Mean
1456931|NCT00800436|Secondary|Terminal Elimination Half-Life (T1/2) of Trastuzumab|T1/2 of trastuzumab was measured as the time required for trastuzumab concentration to decrease by one-half. T1/2 was derived across all PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population|||hours||Standard Deviation|Mean
1456932|NCT00800436|Secondary|Time to Maximum Serum Concentration (Tmax) of Trastuzumab|Tmax of trastuzumab was based on the Cmax derived across all post-dose PK collections and expressed in hours.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population|||hours||Full Range|Median
1456933|NCT00800436|Secondary|Maximum Observed Serum Concentration of Trastuzumab (Cmax)|Cmax of trastuzumab was derived across all post-dose PK collections and expressed in μg/mL.|Postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population|||μg/mL||Standard Deviation|Mean
1456934|NCT00800436|Secondary|Trough Serum Concentration on Day 22 (CDay22) of Trastuzumab|CDay22 of trastuzumab was derived from the single PK collection on Day 22 and expressed in micrograms per milliliter (μg/mL).|Day 22|PK Population|||μg/mL||Standard Deviation|Mean
1456935|NCT00800436|Primary|Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Trastuzumab|AUCinf represents the area under the concentration-time curve of trastuzumab in serum over the time interval from 0 extrapolated to infinity. Values for AUCinf of trastuzumab were derived by non-compartmental analysis across all pharmacokinetic (PK) collections and expressed in days by micrograms per milliliter (days•μg/mL).|Predose (0 hours) and postdose from start of 1.5-hour infusion (1.5 and 3 hours for IV) (6, 8, 12 hours for SC) on Day 1; on Days 2, 3, 5, 8, 15, 22, 43, 85; additionally on Day 10 for SC and Day 35 for IV; and 5 months postdose (up to 5 months overall)|PK Population: All enrolled participants who adhered to the protocol (per protocol basis).|||days•μg/mL||Standard Deviation|Mean
1456936|NCT00800384|Secondary|Perioperative Complication Rate|A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.|30 days|Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.|||participants|||Number
1456937|NCT00800384|Primary|First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death|The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.|Mean follow-up of 3.1 years|All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.|||participants|||Number
1456938|NCT00800345|Secondary|Treatment Response|Treatment response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.|After every 2 cycles of treatment beginning on Cycle 1 Day 1, up to 38 months||||participants|||Number
1456939|NCT00800345|Primary|Dose Limiting Toxicity (DLT)||Cycle 1 (28 days)||||participants|||Number
1456940|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
1456941|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 1 Year Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
1456942|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|1 year post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||meters||Standard Deviation|Mean
1456943|NCT00800254|Secondary|Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively|The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
1456944|NCT00800254|Secondary|"Functional Performance Measure: Timed Up & Go Test [TUG] at 3.5 Weeks Post-operatively"|The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||seconds||Standard Deviation|Mean
1456945|NCT00800254|Secondary|Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively|The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.|3.5 weeks post-operatively|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||meters||Standard Deviation|Mean
1456946|NCT00800254|Secondary|Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 1 year|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||change in N-m/kg||Standard Deviation|Mean
1456947|NCT00800254|Primary|Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively|A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.|Baseline through 3.5 weeks|The Participant Flow represents overall study enrollment and withdrawals. In some cases, patients may have returned for testing, but been unable to complete every test due to time constraints, fatigue, or in some cases, inability.|||change in N-m/kg||Standard Error|Mean
1456948|NCT00800202|Secondary|Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST|Overall response defined as best response according to RECIST recorded from date of randomization until disease progression or recurrence. Complete Response (CR): disappearance of all target lesions; Partial response (PR): reduction by at least 30 percent (%) of sum of the longest diameters of each target lesion, taking initial sum of longest diameters as a reference. Participants with a missing response were considered non-responders. 95% CI for one sample binomial using Pearson-Clopper method.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population|||percentage of participants||95% Confidence Interval|Number
1456949|NCT00800202|Secondary|Time to Death|Time to death was determined as the number of months between the first dose of study treatment and the event of death by any cause. Overall survival was analyzed using the Kaplan-Meier method.|Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population; only participants with an event of death were included in the analysis.|||months||95% Confidence Interval|Median
1456950|NCT00800202|Secondary|Probability of Being Alive at 12 and 18 Months||Months 12 and 18|ITT Population|||percent||95% Confidence Interval|Number
1456951|NCT00800202|Secondary|Percentage of Participants Who Died||Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death|ITT Population|||percentage of participants|||Number
1456952|NCT00800202|Primary|Time to Disease Progression or Death|Tumor progression was defined as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. Time to event was determined as the number of months between the first dose of study treatment and the first event of progression or death by any cause. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population; only participants with progression or death were included in the analysis.|||months||95% Confidence Interval|Median
1456953|NCT00800202|Primary|Percentage of Participants With Disease Progression or Death|Tumor progression was defined according to the RECIST criteria as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant|ITT Population|||percentage of participants|||Number
1456954|NCT00800202|Primary|Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months|Tumor progression was defined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as increase by at least 20% in the sum of the longest diameters of each target lesion, taking as a reference the smallest sum of the longest diameters, reported since the start of treatment, or appearance of one or more new lesions. PFS (investigator assessed) was defined as the time between the first dose of study treatment and the first event of progression or death by any cause. Participants without an event were censored the last time they were known to be progression free. PFS was analyzed using the Kaplan-Meier method in each treatment arm.|6 months|ITT Population|||percentage of participants||95% Confidence Interval|Number
1456955|NCT00799903|Secondary|Number of Participants With All-cause Mortality During the Time Period for Vital Status|The number of participants with all-cause mortality was assessed.|From randomization until death or study completion (up to 4.49 years/average of 3.65 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
1456956|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
1456957|NCT00799903|Secondary|Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events|Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
1456958|NCT00799903|Secondary|Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events|Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
1456959|NCT00799903|Secondary|Number of Participants With CV Death During the Time Period for Follow-up of CV Events|CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
1456960|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events|CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
1456961|NCT00799903|Secondary|Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events|CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All Randomized (ITT) Population|||Participants|||Count of Participants
1456962|NCT00799903|Primary|Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events|CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).|From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)|All-randomized Intent-to-treat (ITT) population comprised of all randomized participants.|||Participants|||Count of Participants
1456963|NCT00799825|Primary|Number of Subjects With Pregnancies and Pregnancy Outcomes.||Throughout the study (up to Month 12)|The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.|||Subjects|||Number
1456964|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)|MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.|||Subjects|||Number
1456965|NCT00799825|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.|Throughout the study (up to Month 12)|The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.|||Subjects|||Number
1456966|NCT00799773|Secondary|B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456967|NCT00799773|Secondary|Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)||Measured at Month 12|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456968|NCT00799773|Secondary|Effect of Plasma Exchange on Rituximab Levels||Measured at Month 6|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456969|NCT00799773|Secondary|Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456970|NCT00799773|Secondary|Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456973|NCT00799773|Secondary|Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456974|NCT00799773|Secondary|Relationship Between Clinical and Laboratory Data and Response to Treatment||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456975|NCT00799773|Secondary|Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab||Measured at Days 52 and 82|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456976|NCT00799773|Secondary|Use of Non-study Treatment||Measured at Month 36|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456977|NCT00799773|Primary|Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids||Measured at Day 52|The STAR informed consent form told subjects their data would be combined with other subjects’ data in study reports. Because one treatment arm included only one subject, this subject’s data cannot be combined with other subjects’ data. Therefore, to protect subject confidentiality, results are not being released for this study.||||||
1456978|NCT00799708|Secondary|Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.|Change from baseline in unstimulated labial gland saliva flow rate at Day 7|Baseline and Day 7|All subjects with salivary flow rate measured at baseline and 7 days|||μL/min||90% Confidence Interval|Least Squares Mean
1456979|NCT00799708|Primary|Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7|Subset of genes on the log ratio intensity scale from a microarray platform – signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens– quantified as a ratio of up regulated versus down regulated genes|Baseline and Day 7|All subjects with salivary gland tissue with RNA of acceptable quality based on pre-specified QC criteria|||Fold change||Standard Error|Least Squares Mean
1456980|NCT00799643|Secondary|Response Rates in Patients Initially Treated With Lifestyle Modification, Insulin Secretagogue, Metformin or Combination Therapy||24 and 48 weeks|||||||
1456981|NCT00799643|Secondary|Response Rates for Exceeding Hyperglycemic Targets Between Active and Placebo Treated Groups; Need for Rescue Therapy; Need for Discontinuation of Study Medication||24 and 48 weeks|||||||
1456982|NCT00799643|Secondary|Changes in WBC and Differential, High-sensitivity C Reactive Protein (hsCRP), Other Inflammatory Markers||24 and 48 weeks|||||||
1456983|NCT00799643|Secondary|Change in Lipids (Low-density Lipoprotein Cholesterol [LDL-C], Non-high-density Lipoprotein Cholesterol [Non-HDL-C], Triglycerides [TG], Total Cholesterol [TC], High-density Lipoprotein Cholesterol [HDL C], TC/HDL-C Ratio, and LDL-C/HDL-C Ratio)||48 weeks|||||||
1456984|NCT00799643|Secondary|Response Rates for Reduction in Fasting Glucose of ≥20 mg/dl, a Reduction in HbA1c of ≥0.5%, and a Reduction in HbA1c of ≥0.8%||24 and 48 weeks|||||||
1456985|NCT00799643|Secondary|Change From Baseline in Fasting Glucose Over Time.||48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks|||mg/dl||95% Confidence Interval|Mean
1456986|NCT00799643|Primary|The Primary Outcome for the TINSAL-T2D Study is Change in HbA1c Level From Baseline to Week 48 From Baseline, Compared Between Treatment Groups.|HbA1c (%, percentage of HbA1c) change from baseline.|48 weeks from baseline|Participants with complete data at both Baseline and 48 weeks|||HbA1c units are %||95% Confidence Interval|Mean
1456987|NCT00799617|Secondary|Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia - Hemoglobin (Continuous)|"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 gm/dL from baseline.~Values are means (SDs) for continuous outcomes."|1 year (baseline to month 12)||||proportion of participants||Standard Deviation|Mean
1456988|NCT00799617|Secondary|Cognitive Function Trial - Executive Function - Trail Making Test B - A|"Baseline score and change in score in Executive Function as Measured by Trail-Making Test (TMT) B - A, at baseline, Month 6 and Month 12.~Change in performance on the Trail Making Test was analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version.~Participants are required to connect a set of numbers (Part A) or alternating letters and numbers (Part B) in sequential order. The score for each part is the total time (in seconds) to complete both parts. The outcome analyzed will be the total time for Trails B minus the total time for Trails A to provide a measure of working memory, adjusted for attention and processing speed. Higher scores reflect lower executive function."|1 year (baseline to month 6 to month 12)||||Score on the Trail Making Test scale||95% Confidence Interval|Mean
1456989|NCT00799617|Secondary|Cognitive Function Trial - Spatial Ability Card Rotation Test (CRT)|"Baseline score and change in score in the Spatial Ability Using the Card Rotation Test at baseline, Month 6 and Month 12.~Change in performance on the Card Rotations Test will be analyzed using linear random effects models adjusting for baseline performance, balancing factors, education, and test version. The test consists of a series of 10 primary figures, each of which has 8 corresponding secondary figures. Subjects are asked to determine which of the secondary figures is the same as the corresponding primary figure, and the score is taken as the number of figures answered correctly minus the number of figures answered incorrectly.~The maximum score is 80 for subjects who answer all items correctly."|1 year (baseline to month 6 to month 12)||||Score on the CRT test scale||95% Confidence Interval|Mean
1456990|NCT00799617|Secondary|Cognitive Function Trial - Visual Memory - Benton Visual Retention Test (BVRT)|"Baseline score and mean change in score in the Visual Memory Using the Benton Visual Retention Test (BVRT) from baseline, Month 6 and Month 12.~The BVRT measures short term visual memory and visuo-constructional abilities and was administered and scored according to standard procedures. Each of 10 designs was presented one at a time for 10 seconds, and immediately after the design was withdrawn, the participant was instructed to draw it from memory on a blank sheet of paper. The score was the total number of figures with errors and ranged from 0 to 26. Scores were inverted to 0 to -26 so that higher scores would reflect better performance.~Change in BVRT scores from baseline are treated as continuous and compared between AAMI Androgel and placebo subjects using linear random effects models adjusting for balancing factors as described in the primary analysis."|1 year (baseline to month 6 and month 12)||||Score on the BVRT test scale||95% Confidence Interval|Mean
1456991|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Femoral Neck by Dual-energy X-ray Absorptiometry (DXA)|Femoral neck as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456992|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Total Hip by Dual-energy X-ray Absorptiometry (DXA)|Total hip as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456993|NCT00799617|Secondary|Bone Trial - Area Bone Mineral Density (BMD) of Lumbar Spine by Dual-energy X-ray Absorptiometry (DXA)|Lumbar spine as measured by DXA, g/cm2 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456994|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Peripheral Bone by Finite Element Analysis, N|Hip peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456995|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Trabecular Bone by Finite Element Analysis, N|Hip trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456996|NCT00799617|Secondary|Bone Trial - Bone Strength of Hip Whole Bone by Finite Element Analysis, N|Hip whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456997|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Peripheral Bone by Finite Element Analysis, N|Spine peripheral bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456998|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Trabecular Bone by Finite Element Analysis, N|Spine trabecular bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1456999|NCT00799617|Secondary|Bone Trial - Bone Strength of Spine Whole Bone by Finite Element Analysis, N|Spine whole bone (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1457000|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Whole Bone by Quantitative Computed Tomography (QCT)|Hip whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1457001|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Peripheral Bone by Quantitative Computed Tomography (QCT)|Hip peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1457002|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Hip Trabecular Bone by Quantitative Computed Tomography (QCT)|Hip trabecular bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1457003|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Whole Bone by Quantitative Computed Tomography (QCT)|Spine whole bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1457004|NCT00799617|Secondary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Peripheral Bone by Quantitative Computed Tomography (QCT)|Spine peripheral bone as measured by QCT, mg/cm3 (within-arm mean percent change between baseline and month 12 adjusted for balancing factors)|1 year (baseline to month 12)||||percentage of change||95% Confidence Interval|Mean
1457005|NCT00799617|Secondary|Cardiovascular Trial - Coronary Artery Calcium Score, Agatston Units Change From Baseline|Coronary artery calcium score in Agatston units (range of 0 to >400 Agatston units), with higher values indicating more severe atherosclerosis).|1 year (change from baseline to month 12)|All participants with measurements of both baseline and 12-month assessments were included in the analysis.|||Agatston units||95% Confidence Interval|Least Squares Mean
1457006|NCT00799617|Secondary|Cardiovascular Trial - Total Plaque Volume Change From Baseline|Total plaque volume,mm3 measured by coronary computed tomographic angiography|1 year (change from baseline to month 12)||||mm^3||95% Confidence Interval|Mean
1457007|NCT00799617|Secondary|Vitality Trial - Patient Health Questionnaire 9 (PHQ-9) Change in Overall Score|"Baseline score and change in score in the Patient Health Questionnaire 9 (PHQ-9) from baseline to Month 12.~Scores on the Patient Health Questionnaire 9 (PHQ-9) depression scale range from 0 to 27, with higher scores indicating greater intensity of depressive symptoms."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PHQ-9 test scale||Standard Deviation|Mean
1457490|NCT00796510|Primary|Overall Survival|Overall survival is the duration from first dose to death. For participants who are lost to follow-up, survival was censored at the last date of follow-up.|Baseline and every 12 weeks up to Week 18|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.|||weeks||Standard Deviation|Mean
1457008|NCT00799617|Secondary|Vitality Trial - Change in the Total Negative Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12|"Baseline score and change in the total negative affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.~Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PANAS test scale||Standard Deviation|Mean
1457009|NCT00799617|Secondary|Vitality Trial - Change in the Positive Affect Score of the Positive and Negative Affect Scales (PANAS) From Baseline to Month 12.|"Baseline score and change in the total positive affect score of the Positive and Negative Affect Scales (PANAS) from baseline to Month 12.~Scores for positive affect and for negative affect on the Positive and Negative Affect Schedule (PANAS) scales range from 5 to 50, with higher scores indicating a greater intensity of the affect."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PANAS test scale||Standard Deviation|Mean
1457010|NCT00799617|Secondary|Vitality Trial - SF-36 Score|Baseline score and change in the SF-36 Vitality Score from baseline to Month 12 Scores on the vitality scale of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating less fatigue.|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the SF-36 vitality scale||Standard Deviation|Mean
1457011|NCT00799617|Secondary|Vitality Trial - FACIT Fatigue Overall Score|Baseline score and change in the FACIT– Fatigue score from baseline to Month 12. Scores on the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale range from 0 to 52, with higher scores indicating less fatigue.|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the FACIT- Fatigue test scale||Standard Deviation|Mean
1457012|NCT00799617|Secondary|Physical Function Trial - PF 10 Overall Score|"Baseline score and the change in score on the physical-function scale (PF-10) of the Medical Outcomes Study 36-Item Short Form Health Survey range from 0 to 100, with higher scores indicating better function.~Scores were measured as the change from baseline to Month 12."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the PF-10 test scale||Standard Deviation|Mean
1457013|NCT00799617|Secondary|Physical Function Trial - The Physical Function Domain (PF-10) of the SF-36 - no./Total no. (%)|The number of participants whose score on the physical-function domain (PF-10; range, 0 to 100, with higher scores indicating better function) of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) increased by at least 8 points from baseline to Month 12.|1 year (change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.|||Participants|||Count of Participants
1457014|NCT00799617|Secondary|Physical Function Trial - 6 Minute Walk Test - Total Walking Distance in Meters|Baseline score and the change in distance walked in the 6-Minute Walking Test in meters from baseline to Month 12|1 year (change from baseline to month 3, 6, 9 and 12)||||meters||Standard Deviation|Mean
1457015|NCT00799617|Secondary|Sexual Function Trial - Erectile Function|"Baseline score and the change in score on the International Index of Erectile Function (IIEF) from baseline to Month 12.~Scores on the IIEF range from 0-30, with higher scores indicating better function."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the IIEF test scale||Standard Deviation|Mean
1457016|NCT00799617|Secondary|Sexual Function Trial - Sexual Desire Domain|"Baseline score and the changes in the score of the sexual-desire domain of the Derogatis Interview for Sexual Functioning in Men-II (DISF-M-II), from baseline to Month 12.~Scores on the (DISF-M-II) range from 0 to 33, with higher scores indicating greater sexual desire."|1 year (change from baseline to month 3, 6, 9 and 12)||||Score on the DISF-M-II scale||Standard Deviation|Mean
1457017|NCT00799617|Primary|Anemia Trial - Effect of Testosterone on Hemoglobin Levels - Unexplained Anemia|"Proportion of men age 65 years or older with unexplained anemia who increased their hemoglobin level by 1.0 g/dL from baseline.~Values are No. (%) for dichotomous outcomes. Dichotomous hemoglobin response is an increase of 1 g/dL or more from baseline."|1 year (change in hemoglobin g/dL from baseline to month 3, 6, 9 and 12)|Unexplained anemia is anemia that is not due to the following causes: iron and vitamin B12 deficiency, chronic inflammation and disease, chronic renal insufficiency, myelodysplastic syndromes.|||Participants|||Count of Participants
1457018|NCT00799617|Primary|Cognitive Function Trial - Delayed Paragraph Recall Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII)|"Baseline score and change in score of the Wechsler Memory Scale Revised Logical Memory II (WMS-R LMII) test of Delayed Paragraph Recall, at baseline, Month 6 and Month 12.~The WMS-R LM II involves a delayed paragraph recall activity scored in two components, each ranging from 0-25. The final score is the sum of each component, therefore falling in the range 0-50. WMS-R LM II scores were treated as continuous with change compared between treatment arms using linear random effects models adjusting for several factors: site, indicator variables of participation in each primary efficacy trial, baseline testosterone concentration (<200), age (≤ 75), use of anti-depressants, use of PDE-inhibitors, baseline WMSR, categorical education, and version of the WMSR."|1 year (change from baseline to month 6 and month 12)|Men, age 65 years or older with low testosterone and Age-Associated Memory Impairment (AAMI)|||percentage of change in test score||95% Confidence Interval|Mean
1457019|NCT00799617|Primary|Bone Trial - Volumetric Bone Mineral Density (BMD) of Spine Trabecular Bone by Quantitative Computed Tomography (QCT) in Older Men With Low Testosterone|Volumetric Bone Mineral Density (BMD) of spine trabecular bone as measured by QCT, mg/cm3, the calculated change in measurement from baseline to Month 12|1 year (QCT measurement of BMD change between baseline and month 12)||||mg/cm^3||95% Confidence Interval|Mean
1457020|NCT00799617|Primary|Cardiovascular Trial - Assess Impact of Testosterone Treatment in Older Men on Noncalcified Plaque Volume|Non-calcified coronary artery plaque volume, mm3, as determined by coronary computed tomographic angiography (CTA), mean difference in change from baseline to month 12|1 year (change in plaque volume measurement from baseline to month 12)|Men aged 65 years or > with an average of 2 serum testosterone levels lower than 275 ng/L and enrolled in the CV Trial of the Testosterone Trials between June 2010 and June 2014.|||mm^3||95% Confidence Interval|Mean
1457123|NCT00798720|Primary|Three-month Progression-free Survival|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions."|Three-months post-treatment||||percentage of participants||95% Confidence Interval|Number
1457021|NCT00799617|Primary|Vitality Trial - Increase in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score Greater Than or Equal to 4 - no./Total no. (%)|"The number of participants whose score on the FACIT–Fatigue scale increased by at least 4 points.~Scores on the FACIT- Fatigue scale range from 0 to 52, with higher scores indicating less fatigue."|1 year (Number of participants who increased FACIT-Fatigue score > or = to 4, change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.|||Participants|||Count of Participants
1457022|NCT00799617|Primary|Physical Function Trial - The 6-Minute Walk Test - no./Total no. (%)|The number and percentage of men who increased the distance walked in the 6-Minute Walk Test by at least 50 meters.|1 year (Number of participants who increased walk distance > or = 50 meters, change from baseline to month 3, 6, 9 and 12)|The number analyzed differs from the overall number due to participant withdrawal or test results that were incomplete.|||Participants|||Count of Participants
1457023|NCT00799617|Primary|Sexual Function Trial - Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Month 12|"Baseline score and change in responses to Question 4 of the Psychosexual Daily Questionnaire (PDQ-Q4) from baseline to Month 12.~Question 4 asks 12 questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.~The change is measured form the baseline value to Month 12."|1 year (change from baseline to month 3, 6, 9 and 12)||||units on the PDQ-Q4 scale||Standard Deviation|Mean
1457024|NCT00799604|Primary|The Mean Maximum Percent Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum percent change is defined as the maximum absolute change divided by the baseline value of bolus 1 and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.|||percent change||Standard Deviation|Mean
1457025|NCT00799604|Secondary|Change in Heart Rate After Bolus 1 (Pre-anesthesia).|The baseline heart rate was measured as the median of all the heart rate measurements within 60 seconds or at the start of the administration of Bolus 1.|Baseline up until the first 15 minutes following Bolus 1 (pre-anesthesia).|Safety population: all enrolled patients (irrespective of eligibility) who are dosed with clevidipine. The safety population will be the primary population used for the safety analyses.|||beats per minute (bpm)||Standard Deviation|Mean
1457026|NCT00799604|Secondary|The Median Time to 50%, and, When Available, 90% Recovery From Maximum SBP Effect Following the First Bolus Dose of Clevidipine for Patients Who Achieved the Endpoints (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Analysis is of the time in minutes between the recorded time at the maximum absolute change and the time of the systolic blood pressure value at the first 50% recovery. The 50% recovery value is equal to the minimum recorded systolic blood pressure value plus 50% of the maximum amount of systolic blood pressure reduction (the Bolus 1 baseline value minus the value at the maximum absolute change).|Up to 15 minutes following the first bolus dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||minutes||95% Confidence Interval|Median
1457027|NCT00799604|Secondary|The Mean Percent Change in Systolic Blood Pressure From Baseline Over Time During the First 15 Minutes Following First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. SBP change (percent change) from baseline is calculated at each collection time point after bolus 1 dose for each patient.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||percent change||Standard Deviation|Mean
1457028|NCT00799604|Secondary|The Median Time to 5%, 10%, and 15% Systolic Blood Pressure Reduction From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 -Pre-anesthesia).|BP was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of bolus 1 is defined as median of all measurements prior to or at the start of Bolus 1. The time at which first target SBP reduction (ex. 5%) from baseline was reached was identified for each patient using fitted values from LOWESS method. Kaplan-Meier method was used to estimate the median time. Patients who never reached 5%, 10% or 15% reduction, withdrew from study or changed antihypertensive within 15 minutes were censored.|From start to 15 minutes of Bolus 1 of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||minutes||95% Confidence Interval|Median
1457029|NCT00799604|Secondary|The Percentage of Patients With Systolic Blood Pressure ≤85 mm Hg Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|The percentage is calculated using the number of patients with a systolic blood pressure ≤85 mm Hg within 15 minutes from the initial Bolus 1 dose divided by the total number of patients who were treated with a Bolus 1 clevidipine, and multiplied by 100.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who are eligible for the study and treated with clevidipine. The mITT population will be the primary population for the analyses of efficacy.|||percent patients||95% Confidence Interval|Number
1457146|NCT00798655|Primary|Probability of Progression-free Survival (PFS) at 2 Years||Up to 90 months for cohort; individual patients up to 24 months after study treatment|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.|||percentage of participants||95% Confidence Interval|Number
1457030|NCT00799604|Primary|The Mean Maximum Absolute Change in Systolic Blood Pressure From Baseline Within 15 Minutes From the First Bolus Dose of Clevidipine (Treatment Period 1, Bolus 1 - Pre-anesthesia).|Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value.|From start to 15 minutes of Bolus 1 dose of clevidipine (pre-anesthesia).|Modified Intent-to-Treat (mITT) population: all enrolled patients who were deemed eligible for the study by meeting all inclusion and no exclusion criteria and were treated with clevidipine. The mITT population is the primary population for the analyses of efficacy.|||mm Hg||Standard Deviation|Mean
1457031|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination|Microbiological sampling results categorized according to direct examination (identification of the class of germs).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation; participants may be represented in >1 category.|||percentage of participants|||Number
1457032|NCT00799591|Secondary|Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture|Microbiological sampling results categorized as a positive blood culture (presence of infection).|Post-baseline (Day 1) through last dose of study treatment or up to 25 months|ITT population. N=number of participants with analyzable data at observation.|||percentage of participants|||Number
1457033|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.|||percentage of participants|||Number
1457034|NCT00799591|Secondary|Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT|Combinations of antibiotic treatments for participants treated with clinical success with tigecycline. Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.|Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months|ITT population; N=number of participants treated with combinations of antibiotics with analyzable data at observation.|||percentage of participants|||Number
1457035|NCT00799591|Secondary|Mean Duration (Days) of Treatment With Tigecycline||Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population|||days||Standard Deviation|Mean
1457036|NCT00799591|Secondary|Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose|Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days. Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.|Baseline (Inclusion) through last dose of study treatment or up to 25 months|ITT population|||percentage of participants|||Number
1457037|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months|ITT population; N=number of participants with analyzable data at observation.|||percentage of participants||95% Confidence Interval|Number
1457038|NCT00799591|Primary|Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)|Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection. Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event. Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.|End of Treatment (on the day of last dose of study treatment) or up to 25 months|Intent-to-Treat (ITT): all participants included in the study who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
1457039|NCT00799578|Primary|Normalization or >50% of Serum ALT Levels From Baseline||6 months||||participants|||Number
1457040|NCT00799487|Secondary|Hour 8.75 Packet Activity - Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457041|NCT00799487|Secondary|Hour 8.75 Packet Activity - Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457042|NCT00799487|Secondary|Hour 8.75 Packet Activity - Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457043|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457044|NCT00799487|Secondary|Hour 8.75 Packet Activity - Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457045|NCT00799487|Secondary|Hour 8.75 Packet Activity - Identiy Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457046|NCT00799487|Secondary|Hour 8.75 Packet Activity - Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order)(range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457047|NCT00799487|Secondary|Hour 3.0 Grammar Task|This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457557|NCT00795951|Primary|Diagnostic Performance: Wool Alcohol|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All enrolled subjects|||participants|||Number
1457048|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Number of targets missed. Higher score is preferable (observed range: -419.4, 108.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Targets missed||Standard Deviation|Mean
1457049|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
1457050|NCT00799487|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (observed range: 0, 212), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. Children read 3 stories and completed the forms. A higher score was preferable and indicated a greater number of words read correctly in the time allowed|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457051|NCT00799487|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)|The THS-R is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes the 10 subtests: writing from memory the upper- and lower-case letters of the alphabet in order, writing from dictation the upper and lower-case letters of the alphabet out of order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). A higher score was preferable (observed range: 0, 118).|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457052|NCT00799487|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT)|Gray Silent Reading Test (GSRT) is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (observed range: 0, 141). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457053|NCT00799487|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
1457054|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Responses to non-targets. Higher score is preferable (observed range: -82.4, 128.9).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Responses to non-targets||Standard Deviation|Mean
1457055|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
1457056|NCT00799487|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Correct Sequences||Standard Deviation|Mean
1457057|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. SD of response times (msecs) (observed range: -177.6, 132.9). Higher score indicates less variability.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||milliseconds||Standard Deviation|Mean
1457058|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target. Mean response latency in msecs (observed range: -75.4, 129.5). Higher score indicates faster reaction time.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Milliseconds (msecs)||Standard Deviation|Mean
1457059|NCT00799487|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score|The TOVA is a computerized, visual continuous performance test which provides measures of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. The first half of the TOVA requires that the child sustain attention while the second half requires inhibition of response to a non-target (observed range: -15.2, 5.2). An ADHD score of less than -1.80 is suggestive of ADHD.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457060|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of child impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457061|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457062|NCT00799487|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of children impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0,36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Units on a scale||Standard Deviation|Mean
1457063|NCT00799487|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Problems correct||Standard Deviation|Mean
1457064|NCT00799487|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable.)|Hour 4 of the Double-Blind Assessment Period Lab School Day|No randomized children were included at this time point. The number of children treated with placebo is based on 68 children minus 3 children who did not crossover and minus 1 child who dropped out before laboratory day 2. The number of children treated with CONCERTA is based on 68 children minus 1 child who dropped out before laboratory day 2.|||Problems attempted||Standard Deviation|Mean
1457065|NCT00799474|Secondary|Knowledge of HPV|Assessed participants' knowledge of HPV by summing correct responses to nine HPV knowledge items. Questions addressed what diseases are associated with HPV, how HPV is transmitted, and how common HPV infection is. For each item, participants were classified as having answered the item correctly or incorrectly.|At time of interview|HPV knowledge items were only asked to those men who had heard of HPV prior to survey (n=430)|||Correct Responses||Standard Deviation|Mean
1457066|NCT00799474|Secondary|Awareness of HPV Vaccine|"Measured if participants had heard of HPV vaccine prior to survey. Participants were asked if they had heard to HPV vaccine prior to the survey and had response options of yes, no, and I don't know."|At time of interview||||Participants|||Number
1457067|NCT00799474|Primary|Willingness to Receive the Human Papillomavirus (HPV) Vaccine|"Measured participants' willingness to receive HPV vaccine. Participants were asked how willing they would be to get HPV vaccine if it were approved for use in males. A 5-point scale ranging from definitely not willing to definitely willing was used to meausure willingness."|at time of interview|One man reported having received human papillomavirus (HPV) vaccine so he was not asked willingness items which made the analytic sample size n=608|||Participants|||Number
1457068|NCT00799435|Secondary|Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide||Measured at Week 12|||||||
1457069|NCT00799435|Primary|Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity||Measured at Week 12|||||||
1457070|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week|Lens diameter at dispense was as listed on product label: 14.0 mm. Lens diameter at 1 week was as measured after lens removal. A positive number indicated a widening of lens diameter.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.|||mm||Standard Deviation|Mean
1457071|NCT00799422|Secondary|Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week|Lens base curve at dispense was as listed on product label: 8.4 millimeters (mm). Lens base curve at 1 week was as measured after lens removal. A negative number represented a steepening of the base curve.|Dispense (Day 0), 1 week|This reporting group includes all participants who completed all study visits.|||mm||Standard Deviation|Mean
1457072|NCT00799422|Primary|Mean Circumlimbal Conjunctival Staining Score|Circumlimbal conjunctival staining was expressed as the sum of the individual scores observed across all of the evaluated regions of the eye. The bulbar conjunctiva was assessed by the investigator utilizing a slit-lamp and lissamine green ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 4-point clinical grading scale (grade 0-3), where Grade 0 = No staining present; Grade 1 = Slight staining present; Grade 2 = Moderate staining present; and Grade 3 = Dense staining present. The scores for the four regions were summed, with a sum score range of 0-12. A lower score represents a more desirable outcome.|1 week|This reporting group includes all participants who completed all study visits.|||Units on a scale||Standard Deviation|Mean
1457073|NCT00799409|Secondary|Hour 8.75 Packet Activity Decode the Mystery Sentence|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457074|NCT00799409|Secondary|Hour 8.75 Packet Activity Word Search|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457075|NCT00799409|Secondary|Hour 8.75 Packet Activity Complete Sentences Using Words Provided|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457076|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Multiple Meanings for Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457077|NCT00799409|Secondary|Hour 8.75 Packet Activity Alphabetize List of Words|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457078|NCT00799409|Secondary|Hour 8.75 Packet Activity Identify Root Word|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457079|NCT00799409|Secondary|Hour 8.75 Packet Activity Short Story With Questions for Comprehension|Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457080|NCT00799409|Secondary|Hour 3.0 Grammar Task|This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses).|Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457081|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457082|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 16).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Trials||Standard Deviation|Mean
1457679|NCT00795145|Secondary|Cohort 2: Vss|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||L/kg||Standard Deviation|Mean
1457083|NCT00799409|Secondary|Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)|The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed.|Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457084|NCT00799409|Secondary|Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score|The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.|Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457085|NCT00799409|Secondary|Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient|Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.|Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457086|NCT00799409|Secondary|Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards|Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Trials||Standard Deviation|Mean
1457087|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457088|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards|WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Sequences||Standard Deviation|Mean
1457089|NCT00799409|Secondary|Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards|WRAML-2 (range: 0, 28) is designed to evaluate a child’s ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly in reverse order. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Correct Sequences||Standard Deviation|Mean
1457090|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457091|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457092|NCT00799409|Secondary|Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score|The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).|Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457093|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457094|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457095|NCT00799409|Secondary|Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)|The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Units on a scale||Standard Deviation|Mean
1457096|NCT00799409|Primary|Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.|Hour 4 of the Lab School Day During the Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point.|||Problems correct||Standard Deviation|Mean
1457097|NCT00799409|Primary|Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)|PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)|Hour 4 of the of the Lab School Day during Double-Blind Assessment Period|Intent-to-Treat Analysis Set. Not randomized children were excluded from this time point. Intent-to-Treat for Placebo and Concerta columns in the primary and secondary results are comprised of the 36 children randomized to Placebo/CONCERTA (lab day 1/lab day 2) plus the 35 children randomized to CONCERTA/Placebo|||Problems attempted||Standard Deviation|Mean
1457098|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel Plus Aspirin|Baseline minus post clopidogrel/post-aspirin platelet rich plasma (PRP) maximum aggregation|Measured at baseline, and after clopidogrel plus aspirin treatment||||percentage of max aggregation change||Standard Deviation|Mean
1457099|NCT00799396|Primary|Changes in Platelet Function in Response to Clopidogrel|Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation.|Measured at baseline, and after clopidogrel treatment||||percentage of maximum aggregation change||Standard Deviation|Mean
1457100|NCT00799383|Secondary|Polar Section Modulus|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm^3||Standard Deviation|Mean
1457101|NCT00799383|Secondary|Endosteal Circumference|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm||Standard Deviation|Mean
1457102|NCT00799383|Secondary|Periosteal Circumference|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm||Standard Deviation|Mean
1457103|NCT00799383|Secondary|Cortical Thickness|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mm||Standard Deviation|Mean
1457104|NCT00799383|Secondary|Cortical Bone Mineral Density|This was measured at the 20% radius site.|36 weeks|Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.|||mg/cm^3||Standard Deviation|Mean
1457105|NCT00799383|Secondary|Bone Strength Index, mg2/mm4|Measured at the 4% radius site.|36 weeks|Sample size is smaller because scans with movement artifact were removed at baseline. At follow up, attrition also contributed.|||mg^2/mm^4||Standard Deviation|Mean
1457107|NCT00799383|Primary|Trabecular Bone Mineral Density in the Ultradistal Radius|"Peripheral quantitative computed tomography (pQCT) scan was obtained at the 4% and 20% sites of the nondominant radius to estimate trabecular and cortical BMD, respectively. A Stratec XCT-2000 scanner, software version 6.0 (Stratec, Inc., Pforzheim, Germany),was used. Trabecular BMD was measured as the mean density of the 85% central area of the bone’s cross-section.~Outcomes were measured at baseline, 18 weeks, and 36 weeks later."|36 weeks|The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded. At late time points, the sample size reflects both attrition and exclusion due to movement artifact.|||mg/cm^3||Standard Deviation|Mean
1457108|NCT00799292|Primary|Estimated Blood Loss|Estimated blood loss as mL|Duration of vaginal hysterectomy||||mL||Standard Deviation|Mean
1457109|NCT00799292|Secondary|Operative Time and Complication Rates||Duration of procedures and immediate post-operative stay in hospital|||||||
1457110|NCT00799292|Primary|Intra-operative Blood Loss During Vaginal Hysterectomy||Blood loss will be assessed at the end of the operative procedure|||||||
1457111|NCT00799227|Secondary|Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye|Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%).|Baseline, Week 26|Intent to Treat: all enrolled patients|||Percentage of Patients|||Number
1457112|NCT00799227|Secondary|Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to treat: all enrolled patients|||Percentage of Patients|||Number
1457113|NCT00799227|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients|||Letters Read Correctly||Standard Deviation|Mean
1457114|NCT00799227|Primary|Change From Baseline in Central Retinal Thickness in the Study Eye|Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Week 26|Intent to Treat: all enrolled patients|||Microns||Standard Deviation|Mean
1457115|NCT00798967|Secondary|Absolute Change in PN/I.V. Volume From Baseline to Last Time Point|Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).|Week 0 to last visit when data was collected.|Intent-to-Treat (ITT) was defined for efficacy analyses which included all randomized patients.|||Liters/Week||Standard Deviation|Mean
1457116|NCT00798967|Primary|Responder|Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.|Weeks 20 and 24|Percentages were based on the number of subjects in the Intent to Treat (ITT) population.|||subjects|||Number
1457117|NCT00798889|Primary|Duration of Treatment||Baseline up to Day 28 after last dose of study treatment|The intent-to-treat population included all participants who were enrolled in the study and received at least 1 dose of study medication.|||Days||Full Range|Median
1457118|NCT00798759|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.|||Units on a scale||Standard Error|Mean
1457119|NCT00798759|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|Day 0, Day 84|Intent-to-Treat: All patients who received test article and completed the trial.|||Seconds||Standard Error|Mean
1457120|NCT00798720|Secondary|Toxicity|Graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|30 days post-treatment||||participants|||Number
1457121|NCT00798720|Secondary|Median Overall Survival||5 years||||months||95% Confidence Interval|Median
1457122|NCT00798720|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI, CT, or chest x-ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Until disease progression, up to 2 years||||participants|||Number
1457680|NCT00795145|Secondary|Cohort 2: CL|Drug clearance = Dose / AUC inf|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||mL/min/kg||Standard Deviation|Mean
1457124|NCT00798707|Other Pre-specified|Discontinuation-Emergent Signs and Symptoms (DESS) Total Score|DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of “new symptoms” and “old (but worse) symptoms” (1) and 0 for “old and unchanged symptom,” “absent,” or “old symptom but improved” for a total possible range of 0 to 43. A higher score indicates more symptoms.|Week 8 to 10 (or ET)|Analysis included completers for exposure (those whose exposure duration was at least 53 days) among safety population. 'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1457125|NCT00798707|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at FOT Evaluation (Week 8 or ET)|C-SSRS mapped into C-CASA(1-7) to assess whether participant:completed suicide(1),suicide attempt(2)(response of “Yes” on “Actual Attempt”),preparatory acts toward imminent suicidal behavior (3)(“Yes” on “Preparatory Acts or Behavior”),suicidal ideation (4)(“Yes” on “Wish to be dead”,“Non-Specific Active Suicidal Thoughts”,“Active Suicidal Ideation with methods without Intent to Act or Some Intent to Act,without Specific Plan or with Specific Plan and Intent),any suicidal behavior or ideation,self-injurious behaviour(7)(“Yes” on “Has subject engaged in Non-suicidal Self-Injurious Behavior”).|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Participants|||Number
1457126|NCT00798707|Other Pre-specified|Percentage of Participants With Sexual Dysfunction at FOT Evaluation (Week 8 or ET)|ASEX scale includes 5 questions that evaluate sexual function exclusively during the week prior to completion in the following areas: libido, excitability and ability to reach orgasm. Sexual dysfunction=an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. Participants who have had no sexual activity during the prior week should be instructed to not complete questions 3 through 5.|Week 8 (or ET)|The safety population included all participants randomly assigned to treatment who had taken at least 1 dose of double-blind study drug.|||Percentage of Participants|||Number
1457127|NCT00798707|Other Pre-specified|Change From Baseline in WHO-5 Total Score at FOT Evaluation (Week 8 or ET)|WHO-5 evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0= worst possible quality of life; 25=best possible quality of life).|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1457128|NCT00798707|Other Pre-specified|Change From Baseline in SDS at FOT Evaluation (Week 8 or ET)|SDS: a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life, and Family Life/Home Responsibilities. The participant rates the extent to which each of these domains is impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired, 10=extremely impaired) for a total maximum score of 30.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation,had taken at least 1 dose of double-blind study drug,had at least 1 primary efficacy evaluation after first dose of double-blind drug.'n' is participants who received drug and were evaluated for measure at timepoint for each group respectively.|||Units on a scale||Standard Error|Mean
1457129|NCT00798707|Other Pre-specified|Population Pharmacokinetics for Desvenlafaxine Plasma Concentrations|Relationship of demographic variables (age, gender, food, race, creatinine, aspartate aminotransaminase, alanine transaminase, bilirubin and concomitant medications) were examined by fitting measured DVS plasma concentrations to a 1 compartment model with first order absorption. Demographic variables were examined for clearance (CL/F), volume of distribution (V/F), Steady Area under Curve (AUC) using nonlinear mixed effects modeling. Final parameter estimates for demographic factors effecting CL/F, V/F and AUC were determined.|Week 2, 4 and 8 (or ET)|PK population; data was insufficient examine the effect of demographic variables on the PK of desvenlafaxine. Parameter values were calculated for variables altering CL/F, AUC and V/F. Population parameters from nonlinear mixed effects modeling were not summarized as descriptive statistics.|||nanogram(ng)/mL||Standard Deviation|Mean
1457130|NCT00798707|Secondary|Number of Participants With a Response on the CGI-I Score at FOT Evaluation (Week 8 or ET)|CGI-I responder was defined as a participant with a score of 1 (very much improved) or 2 (much improved) on the CGI-I. CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1457131|NCT00798707|Secondary|Number of Participants With a Response on the MADRS Score at FOT Evaluation (Week 8 or ET)|A MADRS responder was defined as a participant with a 50% or greater decrease from baseline in MADRS score. It measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1457132|NCT00798707|Secondary|Number of Participants in Remission Based on the HAM-D17 at FOT Evaluation (Week 8 or ET)|Remission was defined as a HAM-D17 score of less than or equal to 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1457700|NCT00794924|Secondary|Improvement in Nutritional and Immunological Measurements||45 days|||||||
1457133|NCT00798707|Secondary|Number of Participants With a Response on the HAM-D17 at FOT Evaluation (Week 8 or ET)|A HAM-D17 responder was defined as a participant with a 50% or greater decrease from baseline in HAM-D17 score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1457134|NCT00798707|Secondary|Change From Baseline in HAM-D6 Total Score at FOT Evaluation (Week 8 or ET)|HAM-D6: a standardized, clinician-administered rating scale that assesses 6 items characteristically associated with major depression and is a subset of HAM-D17. HAM-D6 score ranges from 0-22. The scale uses HAM-D17 items: 1, 2, 7, 8, 10 and 13. Item 13 is scored 0-2 and all others are scored 0-4.|Baseline and Week 8 (or ET)|ITT Population: all randomly assigned participants with baseline primary efficacy evaluation had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit,LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1457135|NCT00798707|Secondary|Change From Baseline in MADRS Total Score at FOT Evaluation (Week 8 or ET)|MADRS measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1457136|NCT00798707|Secondary|Change From Baseline in Mean CGI-S Score at FOT Evaluation (Week 8 or ET)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.|Baseline and Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Units on a scale||Standard Error|Mean
1457137|NCT00798707|Secondary|Number of Participants With Categorical Scores on CGI–Improvement (CGI-I) at FOT Evaluation (Week 8 or ET)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 8 (or ET)|ITT Population included all randomly assigned participants who had baseline primary efficacy evaluation, had taken at least 1 dose of double-blind study drug, and had at least 1 primary efficacy evaluation after first dose of double-blind study drug. If participant had a missing value at any visit, LOCF method of imputation was used.|||Participants|||Number
1457138|NCT00798707|Primary|Change From Baseline in HAM-D17 Total Score at the Final On-therapy (FOT)Evaluation (Week 8 or ET)|HAM-D17: a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.|Baseline and Week 8 (or ET)|Intent-To-Treat (ITT) Population:all randomly assigned participants with baseline primary efficacy evaluation, had taken at least 1 dose of double-blind drug and 1 primary efficacy evaluation after first dose of double-blind drug. If participant had missing value at any visit, last observation carried forward (LOCF) method of imputation was used.|||Units on a scale||Standard Error|Mean
1457139|NCT00798694|Secondary|Corneal Staining Score|Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness).|Baseline, 1 month, 2 months|One eye from each patient per arm.|||scores on a scale||Standard Deviation|Mean
1457140|NCT00798694|Secondary|Ocular Surface Disease Index Score|Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time.|Baseline, 1 month, 2 months||||scores on a scale||Standard Deviation|Mean
1457141|NCT00798694|Secondary|Intraocular Pressure|Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.|Baseline, 1 month, 2 months||||mmHg||Standard Deviation|Mean
1457142|NCT00798694|Secondary|Conjunctival Hyperemia Score|Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness).|Baseline, 1 month, 2 months|One eye per participant in each Arm|||units on a scale||Standard Deviation|Mean
1457143|NCT00798694|Secondary|Tear Production|Tear production, measured by Schirmer test in millimeters|Baseline, 1 month, 2 months||||millimeters||Standard Deviation|Mean
1457144|NCT00798694|Primary|Change in Tear Break up Time (TBUT)|Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.|Baseline, 1 month, 2 months|Both eyes combined change from baseline.|||seconds||Standard Deviation|Mean
1457145|NCT00798655|Secondary|Probability of 2-year Overall Survival||Up to 90 months for cohort; individual patients up to 24 months|Patients who received 60-66 Gy over 6-7 weeks) concurrent with cisplatin 30 mg/m^2 and at least once dose of panitumumab 2.5 mg/kg.|||percentage of participants||95% Confidence Interval|Number
1457147|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 nausea data.|||units on a scale||Full Range|Median
1457148|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Nausea Assessed by Treatment-specific Adverse Events Scale|The single-item nausea question was on a 10-points scale with 0=no nausea and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 nausea data.|||units on a scale||Full Range|Median
1457149|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 neuropathy data.|||units on a scale||Full Range|Median
1457150|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Neuropathy Assessed by Treatment-specific Adverse Events Scale|The single-item neuropathy question was on a 10-points scale with 0=no numbness or tingling in fingers and toes and 10=worst numbness or tingling in fingers and toes imaginable. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 neuropathy data.|||units on a scale||Full Range|Median
1457151|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 fatigue data.|||units on a scale||Full Range|Median
1457152|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Fatigue Assessed by Treatment-specific Adverse Events Scale|The single-item fatigue question was on a 10-points scale with 0=no fatigue and 10=as bad as you can imagine. The item scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 fatigue data.|||units on a scale||Full Range|Median
1457153|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LASA data.|||units on a scale||Full Range|Median
1457154|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Overall Quality of Life Assessed by Linear Analogue Self Assessment (LASA)|The overall quality of life (QOL) question was on a 10-points scale with 0=as bad as it can be and 10=as good as it can be. The QOL scores was translated onto a 0 to 100 point scale, with lower values indicating worse symptoms. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LASA data.|||units on a scale||Full Range|Median
1457155|NCT00798603|Secondary|Change From Baseline to Cycle 5 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 5 was calculated by subtracting the baseline scores from the scores at cycle 5.|Baseline and Cycle 5|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 5 LCSS data.|||units on a scale||Full Range|Median
1457156|NCT00798603|Secondary|Change From Baseline to Cycle 3 in Quality of Life (QOL) as Assessed by the Lung Cancer Symptom Scale|Lung Cancer Symptom Scale (LCSS) consist of 9 items that assess the symptoms of lung cancer during the past days on a 10-points scale with 0 as no symptoms and 10 as worse symptoms. The individual item score was translated onto a 0-100 point scale with lower values indicating worse symptoms. An average of the aggregate score of all 9 items was used for a total score. Change from baseline to cycle 3 was calculated by subtracting the baseline scores from the scores at cycle 3.|Baseline and Cycle 3|All participants who met the eligibility criteria, have started the study treatment and had baseline and cycle 3 LCSS data.|||units on a scale||Full Range|Median
1457157|NCT00798603|Secondary|Overall Survival|Overall survival was defined as the time from study enrollment to the time of death from any cause. Overall survival will be censored at the date of the last follow-up visit for patients who are still alive or lost to follow-up.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.|||months||95% Confidence Interval|Median
1457519|NCT00796003|Secondary|Phase II: Median Time to Improvement|Median time required for the participants to achieve overall improvement (complete remission+partial remission+hematologic improvement)|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.|||Days||95% Confidence Interval|Median
1457158|NCT00798603|Secondary|Progression-free Survival|Progression-free survival was defined as the time from study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first. Progression-free survival will be censored at the date of the last contact for patients who are still alive and who have not had disease progression.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.|||months||95% Confidence Interval|Median
1457159|NCT00798603|Secondary|Time to Treatment Failure|Time to treatment failure was defined to be the time from date of registration to the date at which the patient is removed from the treatment due to progression, toxicity, refusal or death from any cause.|Up to 5 years|All participants who met the eligibility criteria and have started the study treatment.|||months||95% Confidence Interval|Median
1457160|NCT00798603|Secondary|Number of Grade 3 or Higher Adverse Events Occurring in >=10% of Patients|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Up to 2.5 years|All participants who received treatment.|||particpants|||Number
1457161|NCT00798603|Secondary|Duration of Response|Duration of response for responders was defined as the time from the date of the first objective status assessment of a confirmed CR or PR to the first date of disease progression. Duration of response will be censored at the date of last post-therapy follow-up visit for responders who have not had disease progression. Duration of response will be calculated for all evaluable patients who have achieved an objective confirmed response.|Up to 5 years|All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.|||months||95% Confidence Interval|Median
1457162|NCT00798603|Secondary|Proportion of Confirmed Tumor Response Defined as an Objective Status of Complete Response or Partial Response on Two Consecutive Evaluations|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:~Complete Response (CR): disappearance of all target and non-target lesions and no new lesions.~Partial Response (PR): disappearance of all target lesions, persistence of one or more non-target lesions, and no new lesions; or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, no appearance of one/more new lesions, unequivocal progression of existing non-target lesions, and no new lesions."|Duration of study until progression (up to 5 years)|All participants who met the eligibility criteria, have started the study treatment and have post-baseline disease assessments.|||percentage of participants||95% Confidence Interval|Number
1457163|NCT00798603|Primary|Progression-free Survival at 6 Months|Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients). A patient is classified as a success if alive and progression-free at 6 months.|6 months|The first 55 participants who met the eligibility criteria and have started the study treatment.|||percentage of participants||95% Confidence Interval|Number
1457164|NCT00798590|Secondary|Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.||||||
1457165|NCT00798590|Primary|To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.||2 years|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.||||||
1457166|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose|No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1.|||Percent bacteria eradicated|||Number
1457167|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hour after administration of first dose|No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1|||Percent bacteria eradicated|||Number
1457168|NCT00798577|Secondary|Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans|Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1|24 hours after administration of first dose||||Percent bacteria eradicated|||Number
1457169|NCT00798577|Secondary|Exploratory Evaluation of Changes in Ocular Signs and Symptoms|"Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis:~Bulbar Conjunctival Injection – 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema – 0 (none) to 3 (Severe) scale. Lid Swelling – 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva – 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale."|Baseline (Day 1) to Day 2||||Participants|||Number
1457170|NCT00798577|Primary|Exploratory Outcomes From Digital Photography|Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.|24 hours after administration of first dose||||Participants|||Number
1457171|NCT00798486|Secondary|Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit|Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).|One hour||||number of participants|||Number
1457172|NCT00798486|Secondary|Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing|"For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as:~The subject could not use the product without HCP assistance.~The subject could not complete the test. User error rendered one or more parts unusable.~The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value."|One hour||||percentage of subjects|||Number
1457173|NCT00798486|Secondary|Average Within Subject Coefficient of Variation CV (PRECISION)|The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.|One hour|Precision Coefficient of Variation (CV)was analyzed using meter results from subject data that had numeric values for duplicate A1c self-tests. Subject data was not used in this outcome measure analysis when there had been a protocol deviation or when one (or both) A1c self-tests resulted in an error code.|||average percentage CV|||Number
1457174|NCT00798486|Primary|Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)|This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.|One hour||||number of A1c results|||Number
1457175|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Episodes per 24 hours||Full Range|Median
1457176|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24|Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary in participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Micturitions per 24 hours||Standard Deviation|Mean
1457177|NCT00798434|Other Pre-specified|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24|Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Micturitions per 24 hours||Standard Deviation|Mean
1457178|NCT00798434|Other Pre-specified|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Episodes per 24 hours||Standard Deviation|Mean
1457179|NCT00798434|Other Pre-specified|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of >=3 divided by number of days that diary data was collected at that visit. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 24|FAS; N=participants with evaluable data.|||Episodes per 24 hours||Standard Deviation|Mean
1457180|NCT00798434|Other Pre-specified|Percentage of Participants With Improvement at Week 24|Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: “My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment.” Treatment Response was set to “Yes” if the first 2 categories (1 or 2) of the scale selected and “No” if the last 2 categories (3 or 4) were selected. Improvement was defined as a rating of 1 or 2.|Pre-baseline and Week 24|Not analyzed|||Percentage of participants|||Number
1457181|NCT00798434|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at Week 12|MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change = observation minus baseline where higher scores indicated better cognitive functioning.|Baseline and Week 12|FAS|||Scores on a scale||Standard Deviation|Mean
1457182|NCT00798434|Secondary|Change From Baseline in EQ-5D- Each Dimension Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of a single utility score. Health State Profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state; 3 indicated worst health state. Scoring formula assigned utility value for each domain in profile. Score was transformed and results in total score could have ranged from -0.594 to 1.000; Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|Not analyzed|||Scores on a scale||Standard Deviation|Mean
1457183|NCT00798434|Secondary|Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess HRQL in terms of single index value. Visual Analogue Scale (VAS) component rated current health state on scale from 0 (worst imaginable health state) to 100 (best imaginable health state). For each question, scores categorized into 3 levels of response, level 1=no health problems, 2=some problems and 3= extreme problems, and health state profile utility score derived from these, which could range from 1 prefect health to -0.594 worst possible health. Change = observation minus baseline, where higher scores indicated a better health state.|Baseline and Week 12|FAS; N=participants with evaluable data; n=participants with evaluable data a specified time point.|||Scores on a scale||Standard Deviation|Mean
1457193|NCT00798434|Secondary|Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Weeks 4|FAS; N=participants with evaluable data|||Participants|||Number
1457184|NCT00798434|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12|KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Range: 0-100, where 0=best outcome/response and 100=worst outcome/response. Change = observation minus baseline, where lower scores indicated better outcome/response.|Baseline and Week 12|FAS; N=participants with evaluable data at sites in the United Kingdom only; n=participants with evaluable data for specific KHQ category. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
1457185|NCT00798434|Secondary|Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24|OAB-S: evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Medication expectation coded on scale 1=Greatly exceeds my expectations to 5=Does not meet my expectations at all. Coding reversed by subtracting initial response value from 6, so higher final response value associated with better fulfilment of OAB medication expectations.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
1457186|NCT00798434|Secondary|Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24|OAB-S: validated self-administered instrument that evaluated OAB medication expectations, daily life with OAB, and satisfaction with OAB medication and included 3 stand-alone items that assessed overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1-5: (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Change = score at Week 24 minus score at Week 12 where higher scores indicated better satisfaction.|Weeks 12 and 24|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
1457187|NCT00798434|Secondary|Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant bothered by bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to 0-100 score where higher scores were less favorable outcome. Questions 1-8 constituted symptom severity/bother score. Questions 9-33 constitute HRQL component, which included domains of coping, concern, sleep, and social function. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.|||Scores on a scale||Standard Deviation|Mean
1457188|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = observation minus baseline and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.|||Scores on a scale||Standard Deviation|Mean
1457189|NCT00798434|Secondary|Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24|OAB-q: self-administered, 33-item, questionnaire assessed how much participant was bothered by selected bladder symptoms during previous week. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores transformed to a score from 0-100 where higher scores represented less favorable outcome. Change = baseline minus observation and higher scores were an improvement.|Baseline and Weeks 4, 8, 12, and 24|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12). Change from baseline to Week 24 not analyzed.|||Scores on a scale||Standard Deviation|Mean
1457190|NCT00798434|Secondary|Change From Baseline in PPUS at Week 24|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 24|Not analyzed|||Participants|||Number
1457191|NCT00798434|Secondary|Change From Baseline in PPUS at Week 12|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Participants|||Number
1457192|NCT00798434|Secondary|Change From Baseline in PPUS at Week 8|PPUS: self-administered, single-item, questionnaire that measured the participant’s perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Scale of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Improvement in PPUS defined as increase of 1 or more points in difference of scores relative to baseline.|Baseline and Week 8|FAS; N=participants with evaluable data|||Participants|||Number
1457194|NCT00798434|Secondary|Change From Baseline in PPBC at Week 24|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 24|Not analyzed|||Participants|||Number
1457195|NCT00798434|Secondary|Change From Baseline in PPBC at Week 12|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 12|FAS; N=participants with evaluable data; LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Participants|||Number
1457196|NCT00798434|Secondary|Change From Baseline in PPBC at Week 8|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference <0).|Baseline and Week 8|FAS; N=participants with evaluable data|||Participants|||Number
1457197|NCT00798434|Secondary|Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4|PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).|Baseline and Week 4|FAS; N=participants with evaluable data|||Participants|||Number
1457198|NCT00798434|Secondary|Percentage of Participants With Improvement at Week 12|Patient Treatment Benefit Scale (PTBS): single-item scale assessed fesoterodine efficacy and safety in participants with overactive bladder. Participants asked to compare their present condition with their condition before start of trial: “My condition has been: 1=Greatly Improved; 2=Improved; 3=Not Changed; 4=Worsened, During Treatment.” Improvement was defined as a rating of 1 or 2.|Week 12|FAS; N=participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percentage of participants|||Number
1457199|NCT00798434|Secondary|Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12|Skin protective agents included incontinence pads, barrier creams, and powders. Change = observation minus baseline, where lower scores were an improvement/decrease in protective skin agents used.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Skin protective agents||Standard Deviation|Mean
1457200|NCT00798434|Secondary|Percentage of Participants Who Were Incontinent at Baseline and Became Dry|Percentage of participants who had at least 1 UUI episode during baseline period and were dry (no UUI episodes) in the 3 days prior to study visits at week 8 and 12. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.|Weeks 8 to 12|FAS; N=number of participants with evaluable data. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percentage of participants|||Number
1457201|NCT00798434|Secondary|Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12|USS total range 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in urinary sensation.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Scores on a scale||Standard Deviation|Mean
1457202|NCT00798434|Secondary|Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with the USS rating of 5 (unable to hold; leak urine)in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
1457203|NCT00798434|Secondary|Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12|UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary. Change = observation minus baseline, where lower scores were an improvement/decrease in UUI episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Episodes per 24 hours||Full Range|Median
1457204|NCT00798434|Secondary|Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method was used for the statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
1457228|NCT00798161|Secondary|Use of Rescue Therapy|The use of rescue therapy (SUs, thiazolidinediones [TZDs], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a ‘confirmed’ glucose level after an overnight fast.|24 weeks|Percentage of patients requiring rescue therapy|||percentage of participants|||Number
1457205|NCT00798434|Secondary|Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12|Nocturnal micturitions defined as micturitions with USS rating 1-5 that occurred between time participant went to bed and time he or she arose to start the next day. USS rating: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine. Calculated as number of nocturnal micturitions divided by number of diary days collected at that visit. Change = observation minus baseline, where lower scores were an improvement/decrease in nocturnal micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Micturitions per 24 hours||Standard Deviation|Mean
1457206|NCT00798434|Secondary|Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
1457207|NCT00798434|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12|Micturitions included episodes of voluntary micturition and episodes of UUI, defined as those micturitions with USS rating of 5 (unable to hold; leak urine) in the diary of participants with UUI at baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturitions.|Baseline and Weeks 4, 8, and 12|FAS; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Micturitions per 24 hours||Standard Deviation|Mean
1457208|NCT00798434|Secondary|Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
1457209|NCT00798434|Secondary|Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Severe micturition-related urgency episodes defined as those with the USS rating >=4. USS rating of 4: Severe feeling of urgency and 5: Unable to hold; leak urine. Change = observation minus baseline, where lower scores were an improvement/decrease in severity of micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS; N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Episodes per 24 hours||Standard Deviation|Mean
1457210|NCT00798434|Secondary|Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12|Micturition-related urgency episodes per 24 hours defined as those with USS Scale rating of >=3 marked for corresponding micturition in diary. USS rating of 3: Moderate feeling of urgency, 4: Severe feeling of urgency, 5: Unable to hold; leak urine. Percent change calculated as: 100* (Urgency Episode at Week x - baseline)/baseline. Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Weeks 4, 8, and 12|FAS;N=participants with evaluable data; n=participants with evaluable data at specific time point. LOCF method used for statistical analyses of the FAS (change from baseline to Week 12).|||Percent change||Full Range|Median
1457211|NCT00798434|Primary|Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12|Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.|Baseline and Week 12|Full Analysis Set (FAS)=randomized participants who took at least 1 dose of double-blind (DB) treatment, had baseline and post-baseline efficacy data for at least 1 endpoint and at least 1 time point during DB treatment; number of participants analyzed (n)=participants with evaluable data at the specified time point.|||Episodes per 24 hours||Standard Deviation|Mean
1457212|NCT00798369|Secondary|Amount of Rescue Medication Taken for Each Treatment Group|Participants who had difficulty in tolerating their pain after the 6-hour post-dose pain assessments and during the first 7 study days were allowed to take a maximum of 30 mg prednisolone (or equivalent dose of prednisone [30 mg]) orally once a day for a maximum of 5 days. In addition, participants could use 500 mg acetaminophen (paracetamol) and/or 30 mg codeine as needed during the first 7 study days. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/dose or 180 mg/day of codeine was allowed during the first 7 days of the study.|7 days after study drug administration|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||mg||Standard Deviation|Mean
1457213|NCT00798369|Primary|The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)|Mean target dose at 24, 48 and 72 hours. Four models: Emax, Logistic, Linear in log-dose, Linear were selected to describe the potential dose-response curve and hence estimate the target dose of canakinumab using baseline Visual Analog Scale (VAS) and Body Mass Index (BMI) as covariates. Target dose was defined as the dose for which the efficacy is equivalent to the efficacy of triamcinolone acetonide 40 mg and was identified by assessing the dose response relationship with regards to the pain intensity in the target joint measured on a 0- 100 mm VAS (0= no pain and 100= unbearable pain).|at 24,48 and 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||mg||95% Confidence Interval|Number
1457214|NCT00798369|Secondary|Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"Serum amyloid A (SAA) were determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mg/L||Standard Error|Least Squares Mean
1457215|NCT00798369|Secondary|High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group|"High sensitivity C-reactive protein (hsCRP) was determined in serum at all visits (Visits 1-5) in order to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.~ANCOVA with treatment group, protein level at baseline and BMI at baseline as covariates."|at 72 hours and 7 days, 4 and 8 weeks post-dose|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||mg/L||Standard Error|Least Squares Mean
1457216|NCT00798369|Secondary|The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint|The median time in days to at least 50% reduction in Pain intensity from baseline as measured by Visual Analog Scale (VAS) for each treatment group. Participants scored their pain intensity in the target joint on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100).|Baseline, within 7 days after randomization|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||Days||95% Confidence Interval|Median
1457217|NCT00798369|Secondary|Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment|Participants scored their global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Slight and Poor.|at 72 hours post-baseline|The Full Analysis Set (FAS) consisted of all participants as randomized that had at least one post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, participants were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
1457218|NCT00798369|Secondary|The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide|The change in pain intensity from baseline to 72 hours and 7 days post dose as measured on a 0-100 mm Visual Analog Scale(VAS): 0= no pain and 100= severe pain. Analysis of Covariance (ANCOVA) with treatment group, VAS at baseline and Body mass Index (BMI) at baseline as covariates. Change from baseline = (post-baseline measurement – baseline).|Baseline,at 72 hrs post-dose and 7 days post-dose|Full Analysis Set consisting of all participants with data for baseline and the given time point for each arm/group. Assessments up to Day 8, with 1 missing pain intensity value had it imputed. LOCF method was applied to impute post-dose measurements. Missing baseline values were replaced by the median baseline assessment|||Units on a scale||Standard Error|Least Squares Mean
1457219|NCT00798317|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)|||percentage of participants|||Number
1457220|NCT00798317|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28|Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.|Day 28|Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)|||percentage of participants|||Number
1457221|NCT00798304|Primary|Percentage of Participants With at Least One Adverse Event (AE)||From signing of informed consent form to completion of study (up to 2 years)||||percentage of participants|||Number
1457222|NCT00798304|Other Pre-specified|Serum Bactericidal Assay (SBA) GMTs for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
1457223|NCT00798304|Other Pre-specified|Percentage of Participants Achieving SBA Titer Levels >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Additional MnB Test Strains||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
1457224|NCT00798304|Other Pre-specified|Percentage of Participants Achieving Response >=1:4 for Additional Meningococcal Serogroup B (MnB) Test Strain-specific SBA Titer||1 month after Dose 2, Dose 3; before Dose 4; 1, 6, 12, 18, 24, 36, 48 months after Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
1457225|NCT00798304|Secondary|Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
1457226|NCT00798304|Secondary|Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 2, Dose 3; before Dose 4|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
1457227|NCT00798304|Primary|Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain||1 month after Dose 3|Results were not reported for this outcome measure because the study was terminated prior to the first scheduled post-vaccination blood draw and no immunogenicity data were collected.||||||
1457229|NCT00798161|Secondary|FPG Change From Baseline at Week 24 for Open-label Patients|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with a baseline on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.|||mg/dL||Standard Deviation|Mean
1457230|NCT00798161|Secondary|HbA1c Change From Baseline at Week 24 for Open-label Patients|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.|Baseline and week 24|The open label set (OLS) included all patients with baseline HbA1c too high to be randomised and were assigned open-label medication, also with an on treatment HbA1c value. The Open label Set (OLS) included all patients treated with at least one dose on open-label L2.5+M1000 medication.|||Percent||Standard Deviation|Mean
1457231|NCT00798161|Secondary|Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24|This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.|Baseline and week 24|Meal tolerance test (MTT) set (patients with adequate MTT results available at the beginning and end of the randomised treatment period)|||mg/dL||Standard Error|Mean
1457232|NCT00798161|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 24|The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.|Baseline and week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1457233|NCT00798161|Secondary|Percentage of Patients With HbA1c < 6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1457234|NCT00798161|Secondary|Percentage of Patients With HbA1c <6.5% at Week 24|The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =< 6.5%|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 6.5%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1457235|NCT00798161|Secondary|Percentage of Patients With HbA1c<7.0 at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|The FAS included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1457236|NCT00798161|Secondary|Percentage of Patients With HbA1c <7.0% at Week 24|The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.|Baseline and Week 24|FAS treated and randomised patients with baseline HbA1c >= 7.0%. Non-completers were considered as failure imputation (NCF).|||percentage of patients|||Number
1457237|NCT00798161|Secondary|FPG Change From Baseline at Week 18|This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 18|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1457238|NCT00798161|Secondary|FPG Change From Baseline at Week 12|This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 12|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1457239|NCT00798161|Secondary|FPG Change From Baseline at Week 6|This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 6|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1457240|NCT00798161|Secondary|FPG Change From Baseline at Week 2|This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 2|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1457241|NCT00798161|Secondary|FPG Change From Baseline at Week 24|This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.|Baseline and week 24|This population includes the FAS using the LOCF imputation, with the further restriction of patients with a baseline and post-baseline FPG value.|||mg/dL||Standard Error|Mean
1457242|NCT00798161|Secondary|HbA1c Change From Baseline at Week 18|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 18|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1457282|NCT00797732|Primary|Outcome Compliance Rate|Outcome compliance rate is the percentage of enrolled participants who completed the primary study assessments (at baseline and in long-term follow-up 6 months post acupuncture treatment).|Assessed at baseline and at 6 months post acupuncture treatment|The analysis population is comprised of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1457243|NCT00798161|Secondary|HbA1c Change From Baseline at Week 12|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 12|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1457244|NCT00798161|Secondary|HbA1c Change From Baseline at Week 6|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 6|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1457245|NCT00798161|Primary|HbA1c Change From Baseline at Week 24|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.|Baseline and week 24|The Full Analysis Set (FAS) included all treated and randomised patients with a baseline and at least one on-treatment HbA1c measurement available. Last observation carried forward (LOCF) was used as the imputation rule.|||Percent||Standard Error|Mean
1457246|NCT00798135|Secondary|Time to Progression.|This is calculated as time till progression from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. If a patient did not progress, they were censored at the last evaluation visit. The median time till progression is calculated with its 95% confidence interval.|up to 100 months|All patients in the study.|||Months||95% Confidence Interval|Median
1457247|NCT00798135|Secondary|Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment|Number of patients with Adverse Events grade 3 or 4 that are related to study treatment. This will look into the safety of the study drug.|up to 100 months|All patients in the study.|||Participants|||Number
1457248|NCT00798135|Primary|Pharmacokinetics (PK) of Oral Itraconazole|To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.|pre-dose at Weeks 2 and 4|All patients with results available.|||ng/mL||Standard Deviation|Mean
1457249|NCT00798096|Secondary|Duration of Overall Response is the Time From First Documentation of Complete or Partial Response, Whichever Occurs Earlier, to Discontinuation of Study Drug.|Duration of Overall Response is the time from first documentation of Complete or Partial Response (Cheson 2007), whichever occurs earlier, to discontinuation of study drug.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Days||Standard Deviation|Median
1457250|NCT00798096|Secondary|Overall Response Rate (ORR) is the Proportion of Patients With a Best Response of Complete Response (CR) or Partial Response (PR).|Overall response rate (ORR) is the proportion of patients with a best response of Complete Response (CR) or Partial Response (PR).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Participants|||Number
1457251|NCT00798096|Secondary|Clinical Benefit Rate is the Proportion of Patients With Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Clinical benefit rate is the proportion of patients with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Participants|||Number
1457252|NCT00798096|Primary|The Primary Efficacy Endpoint for This Study is Overall Regressive Response Rate (ORRR): Proportion of Patients With a Best Response of Complete Response (CR), Partial Response (PR), or Regressive Stable Disease (RSD).|Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.|Serial tumor assessments were taken at baseline (within 28 days of the start of treatment), and re-evaluated at Day 57, and every 8weeks therafter or to confirm response . (Maximum duration of treatment 182 days, Maximum duration of follow-up 217 days)||||Participants|||Number
1457253|NCT00798018|Primary|Visual Analogue Scale(0-100mm) by the Subject.|visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels.|6 hours, 12 hours, 24 hours, 48 hours after extubation||||mm||Standard Deviation|Mean
1457254|NCT00797966|Secondary|Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).|CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved].|Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||percentage of participants|||Number
1457255|NCT00797966|Secondary|Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).|A MADRS remission was defined as MADRS Total Score </= 10 and >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Percentage of participants|||Number
1457256|NCT00797966|Secondary|Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).|A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit).|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Percentage of participants|||Number
1457257|NCT00797966|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.|CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A.|Week 8 to each of Week 9, 10, 11, 12, 13 and 14.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1457258|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.|The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the “best” rating and the highest score (2 or 4) is the “worst” rating. The possible total scores are from 0 to 52.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1457259|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.|"The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place."|Week 8 to each of Week 9, 10, 11, 12, 13 and 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1457260|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1457261|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).|The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1457262|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1457263|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.|The MADRS is utilized as the primary efficacy assessment of a patient’s level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.|Week 8 to each of Week 9, 10, 11, 12 and 13.|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1457291|NCT00797563|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. The rating scale was:~Successful~Successful after being referred to user instructions~Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol|||percent of participants|||Number
1457264|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).|The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1457265|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).|The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5*(minimum score). Range is maximum score minus minimum score. Total score is 100*(Raw score minus minimum score)/ Range, rounded to nearest integer.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Percentage of maximum possible score||Standard Error|Least Squares Mean
1457266|NCT00797966|Secondary|Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14.|Week 8 to Week 14|ITT dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1457267|NCT00797966|Primary|Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.|The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the “best” rating and 6 being the “worst” rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.|Week 8 to Week 14|Intent-to-Treat (ITT) dataset consisted of all randomized participants who had an End of Phase A value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B. The Last Observation Carried Forward (LOCF) method was used to impute missing data.|||Units on a scale||Standard Error|Least Squares Mean
1457268|NCT00797862|Post-Hoc|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 32|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 & 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msSBP was a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
1457269|NCT00797862|Secondary|Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints|Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints.|Baseline to week 8, 16, 24 and 32 endpoints|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure. Last post-baseline observation was carried forward to each visit for the analysis of blood pressure control.|||Percentage of Participants|||Number
1457270|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
1457327|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Albumin - All Treated Population|Albumin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): < LLN - 3.0; GRADE (2): < 3.0 - 2.0; GRADE (3): < 2.0 g/dL.|Day 1 to Week 48||||participants|||Number
1457271|NCT00797862|Secondary|Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks|Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.|Baseline, 8 weeks, 16 weeks and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
1457272|NCT00797862|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32|Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.|Baseline to 32 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
1457273|NCT00797862|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24|Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline to 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
1457274|NCT00797862|Primary|Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks|Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.|Baseline, 8 weeks, 16 weeks, and 24 weeks|The analysis population included participants in the Full Analysis Set, (randomized participants who received at least one dose of study drug) for whom efficacy data was available for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
1457275|NCT00797823|Secondary|Percent of Time Venous Blood Glucose <70 mg/dl||1 year||||percent of time||Standard Error|Mean
1457276|NCT00797823|Primary|Effectiveness of Closed Loop Diabetes Control|Effectiveness of closed loop diabetes control will be measured by mean glucose.|1 year|The number of participants for analysis was determined was per protocol.|||mg/dl||Standard Error|Mean
1457277|NCT00797797|Secondary|Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study|The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain).|Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks)||||mm||Standard Error|Least Squares Mean
1457278|NCT00797797|Primary|Patient Global Impression of Change (PGIC) Responder Rate at End of Study|The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as “very much improved” or “much improved” (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.|End of Randomized treatment period (11 weeks)|All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment.|||participants|||Number
1457279|NCT00797732|Secondary|MDADI Scores|The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.|Assessed at baseline, 20 weeks post chemoradiation therapy and 6 months post acupuncture|The analysis population is comprised of all randomized participants. At each timepoint, a subset of participants were evaluable for quality of life assessment.|||units on a scale||Standard Deviation|Mean
1457280|NCT00797732|Secondary|MDADI Change From Baseline to 12 Months Post Chemoradiation Therapy (CRT)|The M.D. Anderson Dysphagia Inventory (MDADI) is a validated, self-administered questionnaire established as the best measure of dysphagia-related quality of life in HNC patients. (Carlsson S, et al Dysphagia 2012; 27: 361-369). MDADI has two summary scores: 1) global (1 item) and 2) composite (19 items). Each item is scored on a 5 point Likert scale (strongly disagree, disagree, no opinion, agree, strongly agree). The composite MDADI score is a weighted average of the physical, emotional, and functional subscale questions. Scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). A minimal clinically important within group difference was a 10% change from baseline.|Assessed at baseline and 6 months post acupuncture which parallels 12 months post-CRT|The analysis population represents the subset of participants evaluable at baseline and 12 months post CRT/6 months post acupuncture|||units on a scale||95% Confidence Interval|Mean
1457281|NCT00797732|Primary|Treatment Compliance Rate|Treatment compliance rate is the percentage of enrolled participants who completed at least 80% of treatment (10 of 12 acupuncture sessions).|Assessed throughout the 6 month treatment period (12 acupuncture treatments every 2 weeks)|The analysis population is comprised of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
1457283|NCT00797667|Primary|Percentage of Participants Who Had Study Drug Discontinued During the Study Due to an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The percentage of participants who discontinued study was summarized.|up to 12 weeks|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.|||Percentage of Participants|||Number
1457284|NCT00797667|Primary|Percentage of Participants Who Experienced an Adverse Event|Participants were assessed throughout the study for adverse events and recorded adverse events in a daily dairy. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 12 weeks)|All Patients as Treated, which consisted of all participants who received at least 1 dose of study drug and were included in the treatment arm corresponding to the study treatment actually received. If participants took incorrect or mixed study treatment they were included in treatment arm corresponding to the highest dose they actually received.|||Percentage of Participants|||Number
1457285|NCT00797667|Secondary|Change From Baseline in the Mean Number of Days Per Month Requiring Rescue Medication|Participants completed a diary each evening just before going to bed. Information recorded included: date of assessment, administration of study medication, medication to treat breakthrough migraines and other headaches, associated symptoms, duration of headache pain, headache severity, and side effects. Participants use of medication to treat a breakthrough migraine/headache was considered rescue medication. The number of days per month requiring rescue medication was calculated.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Days per month||95% Confidence Interval|Mean
1457286|NCT00797667|Secondary|Change From Baseline in the Mean Monthly Migraine Attacks|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache was accompanied with associated symptoms.( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. A migraine attack was defined as any migraine headache that occurs within 2 consecutive calendar days. Pain persisting for more than 2 days after its initial onset was considered a new, distinct migraine attack. The number of migraine attacks that occurred per month was calculated. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||attacks per month||95% Confidence Interval|Mean
1457287|NCT00797667|Secondary|Percentage of Participants With at Least a 50% Reduction in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days. The percentage of participants who had at least a 50% reduction in mean monthly headache days during the 12 weeks treatment period was summarized|Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Percentage of Participants||95% Confidence Interval|Number
1457288|NCT00797667|Primary|Change From Baseline in Mean Monthly Migraine Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly migraine days; a migraine day was defined as any day in which a qualified headache( i.e., aura, photophobia, phonophobia, nausea, or vomiting) started, ended, or recurred. Migraine pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct migraine days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Days per month||95% Confidence Interval|Mean
1457289|NCT00797667|Primary|Change From Baseline in Mean Monthly Headache Days|Participants entered information about the number of migraine headaches, symptoms, headache pain duration and severity, use of medication, and side effects into a diary each evening just before going to bed. This information was used to determine the mean monthly headache days; a headache day was defined as any day in which a qualified headache (>=30 minute duration or requiring acute treatment) started, ended, or recurred. Headache pain persisting for more than 1 calendar day after initial onset was considered an occurrence of multiple distinct headache days. Mean monthly rate was adjusted to 28 days.|Baseline and Week 12|Full Analysis Set (FAS), which included all randomized patients who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||Days per month||95% Confidence Interval|Mean
1457290|NCT00797563|Secondary|Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour||||number of participants|||Number
1457292|NCT00797563|Primary|Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method|Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.|One hour|"One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study.~The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method."|||number of blood glucose (BG) results|||Number
1457293|NCT00797511|Secondary|Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine|Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1457294|NCT00797511|Primary|Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio|Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers to the vaccine Pertussis antigens were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1457295|NCT00797511|Primary|Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination|Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric mean titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1457296|NCT00797511|Primary|Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.|Day 28 post-vaccination|Anti-Pertussis concentrations were assessed in the per-protocol population.|||Participants|||Number
1457297|NCT00797511|Primary|Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.|"Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA).~Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution)."|Day 28 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.|||Participants|||Number
1457298|NCT00797459|Secondary|Wrinkle Improvement at Day 14|This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.|14 days after treatment when compared to baseline||||participants|||Number
1457299|NCT00797459|Primary|Treatment Difference in Pain as Measured by a Visual Analogue Scale|No pain is noted at 0 mm and worst pain is noted at 100 mm.|After Injection on Day of Treatment|This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS).|||Scores on a VAS Scale|Participants|Standard Deviation|Mean
1457300|NCT00797316|Secondary|Change From Baseline to Week 8 in Pulse Pressure||Baseline and Week 8|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
1457301|NCT00797316|Secondary|Percentage of Patients Achieving Blood Pressure Control at Week 8|Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.|8 weeks|Full analysis set|||Percentage of Participants|||Number
1457302|NCT00797316|Secondary|Percentage of Participants With Blood Pressure Response at Week 8|Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.|8 weeks|full analysis set|||Percentage of Participants|||Number
1457303|NCT00797316|Secondary|Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)||8 weeks|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
1457304|NCT00797316|Primary|Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
1457305|NCT00797277|Secondary|Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection|Agitation was further assessed by the Agitation Calmness Evaluation Scale (ACES) (Copyright 1998, Eli Lilly and Company), a single-item scale developed by Eli Lilly and Company on which 1 indicates marked agitation; 2, moderate agitation; 3, mild agitation; 4, normal; 5, mild calmness; 6, moderate calmness; 7, marked calmness; 8, deep sleep; and 9, unable to be aroused.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection|||units on a scale||Standard Deviation|Mean
1457326|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alkaline Phosphatase - All Treated Population|Alkaline Phosphatase was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457306|NCT00797277|Primary|The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection|The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared.|from baseline to 120 minutes after first injection|Those receiving at least one IM injection|||units on a scale||Standard Deviation|Mean
1457307|NCT00797212|Secondary|Percentage of Participant Ratings for Overall Testing Experience With This Meter|Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).|One hour|per protocol|||percent of participants|||Number
1457308|NCT00797212|Secondary|Percentage of Participants Rated as <=3 (Labeling Comprehension)|"Study staff rated participants as to their success at performing meter testing. The rating scale was:~Successful~Successful after being referred to user instructions~Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)~Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)"|One hour|per protocol|||percent of participants|||Number
1457309|NCT00797212|Primary|Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results|Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP|One hour|per protocol|||number of AST Blood Glucose Results|||Number
1457310|NCT00797108|Other Pre-specified|Number of Participants With Healthcare Resource Utilization|Healthcare resource utilization was to be evaluated using the assessment of the following: date and duration of index admission, duration of hospitalization, date of discharge, location of discharge, type/length of treatment inside and outside of the hospital, healthcare professional visits outside of the hospital, emergency room visits, and other hospitalizations.|Baseline up to 15 to 28 days after EOT|This assessment was not performed due to the small sample size and hence data for this outcome measure is not reported.||||||
1457311|NCT00797108|Other Pre-specified|Population Pharmacokinetics|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study.|0.5 to 1 hours, 1.5 to 3 hours, 3 to 5 hours after initiation of first intravenous dose; 0.5 to 2.5 hours, 4 to 6 hours following administration of oral dose on the day of IV to oral switch (minimum of 2 days equivalent on intravenous dose)|||||||
1457312|NCT00797108|Other Pre-specified|Number of Participants With Categorical Change From Baseline in Vital Signs|Participants who met the categorical criteria for increase in vital signs data were reported. Categorical criteria for increase from baseline vital signs data: supine and sitting systolic blood pressure (BP) of greater than or equal to (>=) 30 millimeter of mercury (mmHg); supine and sitting diastolic BP of >=20 mmHg.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants evaluable for this measure for specified category for each arm, respectively.|||participants|||Number
1457313|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Physical Examination Findings|A physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, neurological, extremities, and others. Criteria for abnormal physical findings were based on investigator’s discretion.|Last observation (up to 15-28 days after EOT, approximately 38 days)|ITT population included all randomized participants who received at least 1 dose of double blind study drug.|||participants|||Number
1457314|NCT00797108|Other Pre-specified|Number of Participants With Abnormal Laboratory Test Findings|Criteria for laboratory abnormalities: hemoglobin (Hb), hematocrit, red blood cell (RBC) (less than [<] 0.8*lower limit of normal [LLN]); reticulocyte (absolute and percentage) (<0.5*LLN or greater than [>] 1.5*upper LN [ULN]); platelet (<0.5*LLN or >1.75*ULN); white blood cell (WBC) (<0.6*LLN or >1.5*ULN); lymphocyte, neutrophil (<0.8*LLN or >1.2*ULN); eosinophil, monocyte, basophil (>1.2*ULN); bilirubin (BR) (>1.5*ULN); aspartate and alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase (>3.0*ULN); total protein, albumin (<0.8*LLN or >1.2*ULN);blood urea nitrogen, creatinine (>1.3*ULN); sodium (<0.95*LLN or >1.05*ULN); potassium, chloride, calcium, magnesium, bicarbonate (<0.9*LLN or >1.1*ULN); glucose (<0.6*LLN or >1.5*ULN); urine (pH [<4.5 or >8], glucose, protein, blood, ketone [>=1]). Total number of participants with abnormal laboratory values were reported.|Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1457315|NCT00797108|Other Pre-specified|Number of Participants Who Died||Baseline up to 15 to 28 days after EOT|ITT population included all randomized participants who received at least 1 dose of double blind study drug.|||participants|||Number
1457316|NCT00797108|Secondary|Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit|The CAP Symptom Questionnaire was a participant reported questionnaire administered by interview. It consisted of 12 items (coughing, chest pains, shortness of breath, sweating, chills, headache, nausea, muscle pain, lack of appetite, trouble concentrating, trouble sleeping, and fatigue). Depending on if the participant had or not had symptoms/problems, they were asked how much they had been bothered by the symptoms/problems over the previous 24 hours. CAP items were rated on the 6-point response scale (0 = participant did not have symptom/problem: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely; if the participant had the symptom/problem and were bothered). All 12 items score were summed and averaged to produce a CAP symptom score (range, 0 to 6). High values indicated poorer outcomes (higher symptom bothersomeness).|Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)|Clinically evaluable population. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1457317|NCT00797108|Secondary|Number of Participants With Microbiological Response at Test of Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication=the absence of the original pathogens from the post-treatment TOC culture of specimen from the original site of infection. Presumed eradication=the complete resolution of signs and symptoms associated with cessation of culturable specimen (for example, sputum). Persistence=the presence of the original pathogen in the post-treatment TOC culture specimen from the original site of infection. Presumed persistence=in a participant who was judged to be a clinical failure and a culture of specimen was not possible or was not done, it was presumed that there was persistence of the pathogen. Not applicable microbiologic response included participants that did not have post-treatment microbiologic cultures due to early discontinuation. Data reported for eradication is combination of eradication and presumed eradication data and data reported for persistence is combination of persistence and presumed persistence data.|7 to 14 days after EOT|Microbiologic clinically evaluable population included all microbiologic ITT participants (all ITT participants in whom a pathogen was isolated at baseline) who also met criteria for the clinically evaluable subset.|||participants|||Number
1457318|NCT00797108|Secondary|Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit|CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOT (Day 7 to 10) and follow-up (15 to 28 days after EOT), CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia, development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; with additional CR evaluated as “improvement”= of few not all signs and symptoms of pneumonia when compared to baseline and no additional antibacterial treatment required at EOT and “indeterminate”=extenuating circumstances precluded classification to 1 of the above at follow-up.|EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).|||percentage of participants|||Number
1457319|NCT00797108|Primary|Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit|Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment [EOT]) CR was evaluated as “cure”=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; “failure”=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell [WBC] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; “indeterminate”=extenuating circumstances precluded classification to 1 of the above.|7 to 14 days after end of treatment|Clinically evaluable: all ITT participants who received at least 80% of study drug, no concomitant systemic antibiotic with activity against relevant pathogens, diagnosed with pneumonia as defined by protocol inclusion criteria, assignment of pneumonia severity index (PSI) score III (low: score range 71-90)-IV(high: score range 91-130).|||percentage of participants|||Number
1457320|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Uric Acid - All Treated Population|Uric acid was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 * ULN - 10.0; GRADE (4): > 10.0 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457321|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Lipase - All Treated Population|Total Lipase (as measured with a turbidimetric assay) was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * ULN; GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 X ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457322|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Calcium (High) - All Treated Population|Total Calcium was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 8.0 - < LLN OR > ULN - 11.5; GRADE (2): 7.0 - < 8.0 > 11.5 - 12.5; GRADE (3): 6.0 - < 7.0 > 12.5 - 13.5; GRADE (4): < 6.0 > 13.5 mg/dL.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457323|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Amylase - All Treated Population|Amylase was measured as units per liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 2.0 * ULN; GRADE (3): > 2.0 - 5.0 * ULN; GRADE (4): > 5.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457324|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Serum Potassium (High) - All Treated Population|Serum potassium was measured as milliequivalents per liter (mEq/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN OR > ULN - 5.5;; GRADE (2): > 5.5 - 6.0; GRADE (3): 2.5 - < 3.0 > 6.0 - 7.0; GRADE (4): < 2.5 mEq/L.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457325|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Total Bilirubin - All Treated Population|Total Bilirubin was measured as milligrams per deciliter (mg/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 1.5 * upper limits of normal (ULN); GRADE (2): > 1.5 - 3.0 * ULN; GRADE (3): > 3.0 - 10.0 * ULN; GRADE (4): > 10.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457328|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Aspartate Aminotransferase (AST) - All Treated Population|AST was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48||||participants|||Number
1457329|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Alanine Aminotransferase (ALT) - All Treated Population|ALT was measured as Units per Liter (U/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): > 1.0 - 2.5 * upper limits of normal (ULN); GRADE (2): > 2.5 - 5.0 * ULN; GRADE (3): > 5.0 - 20.0 * ULN; GRADE (4): > 20.0 * ULN.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457330|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Platelet Count - All Treated Population|Platelets were measured as *10^9 cells per liter (c/L). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 75.0 - < LLN; GRADE (2): 50.0 - < 75.0; GRADE (3): 25.0 - < 50.0; GRADE (4): < 25.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457331|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils Plus Bands - All Treated Population|Neutrophils plus bands (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5.|Day 1 to Week 48||||participants|||Number
1457332|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst CTC Grade for Neutrophils - All Treated Population|Neutrophils (absolute) are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 1.5 - < 2.0; GRADE (2): 1.0 - < 1.5; GRADE (3): 0.5 - < 1.0; GRADE (4): < 0.5|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457333|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Lymphocytes - All Treated Population|Lymphocytes (absolute) were measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 0.8 - < 1.5; GRADE (2): 0.5 - < 0.8; GRADE (3): 0.2 - < 0.5; GRADE (4): < 0.2|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457334|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Leukocytes - All Treated Population|Leukocytes are measured as *10^3 cells per microliter (c/µL). National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade. GRADE (1): 3.0 - < LLN; GRADE (2): 2.0 - < 3.0; GRADE (3): 1.0 - < 2.0; GRADE (4): < 1.0.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457335|NCT00796991|Secondary|Number of Participants on Treatment With Toxicity Changes From Baseline by Worst Common Terminology Criteria (CTC) Grade for Hemoglobin - All Treated Population|Hemoglobin was measured in grams per deciliter (g/dL). National Cancer Institute Common Terminology Criteria (CTC) v3.0 was used to determine Grade. GRADE (1): 10.0 - less than (<) lower limit of normal (LLN); GRADE (2): 8.0 - < 10.0; GRADE (3): 6.5 - < 8.0; GRADE (4): < 6.5|Day 1 to Week 48||||participants|||Number
1457336|NCT00796991|Secondary|Mean Baseline Change in Body Temperature at Weeks 16 and 48 - All Treated Population|Temperature was obtained while the participant was sitting down and was measured in degrees Fahrenheit (F). During the induction phase this vital sign was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Temperature was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a temperature value available for analysis.|||degrees F||Standard Deviation|Mean
1457337|NCT00796991|Secondary|Mean Change From Baseline in Respiration Rate at Weeks 16 and 48 - All Treated Population|Respiration rate was obtained while the participant was sitting down and measured in breaths per minute (bpm). During the induction phase respiration rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Respiration rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Respiration rate value available for analysis.|||bpm||Standard Deviation|Mean
1457338|NCT00796991|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 16 and 48 - All Treated Population|Pulse rate was obtained while the participant was sitting down and measured in beats per minute (bpm). During the induction phase pulse rate was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Pulse rate was recorded at Weeks 1, 4, 7, 10, 13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had a Pulse rate value available for analysis.|||bpm||Standard Deviation|Mean
1457339|NCT00796991|Secondary|Mean Change From Baseline at Weeks 16 and 48 in Diastolic and Systolic Blood Pressure - All Treated Population|Blood pressure was obtained while the participant was sitting down and was measured in millimeters of mercury (mmHg). During the induction phase blood pressure was collected 30 minutes prior to dosing and every 30 minutes for the duration of the ipilimumab infusion. Orthostatic blood pressure was to be measured when clinically indicated (for example, participant was experiencing lightheadedness, dizziness, syncope). Blood pressures were recorded at Weeks 1, 4, 7, 10,13, 16, 19, and 22 during the Induction Phase, and at Weeks 24, 36, and 48 during the Maintenance Phase.|Day 1 to Week 48|Treated participants received at least one dose of a study drug. N=number of treated participants who also had blood pressure value available for analysis.|||mmHg||Standard Deviation|Mean
1457340|NCT00796991|Secondary|Mean Absolute Lymphocyte Count (ALC) at Each Nominal Ipilimumab Induction Dose and at End of the Induction Period - Pharmacodynamic Population|Absolute lymphocyte counts were obtained from routine hematology panels from 28 days prior to the first treatment with any study medication through the end of the Induction-Dosing Period and were reported as number*10^3 cells per micro liter (x10^3 c/µL).|Day to Week 12|"Pharmacodynamic Population: All treated participants with one unambiguous date of first dose; and at least 1 ALC evaluation during the induction-dosing period. For each of these participants, all ALC evaluations from 28 days prior to first dose of any study medication to the end of the induction dosing are included.~period."|||10^3 cells/µL||95% Confidence Interval|Mean
1457341|NCT00796991|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, Deaths, and Discontinuation Due to Adverse Events From Day 1 to Week 48 - All Treated Population|Adverse events (AEs) and Serious AEs (SAEs) were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events version 3.0. Week 48 database lock was 27 July 2010.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457342|NCT00796991|Secondary|Number of Participants With Objective Response to Treatment and Disease Control Using mWHO Criteria - All Randomized Participants|Number of participants with an objective response to treatment excluded participants with a best overall response (BOR) of Stable Disease (SD). Disease control is non-progression of disease while on treatment. A participant was considered to have achieved disease control if he/she had a BOR of CR, PR, or SD in the absence of resected index lesions or new lesions while the participant was considered to have an objective response to treatment in he/she had a BOR of CR or PR in the absence of resected index lesions or new lesions.|Day 1 to Week 48|Randomized Population includes all participants randomized to a treatment arm|||participants|||Number
1457343|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Immune Related (ir) Response Criteria (RC) - All Treated Participants|Assessments: Weeks 12, 16, 20, and 24. Participants with resected index or new lesions considered progressed in their disease. The immune-related (ir) response criteria (irRC) represents further modifications of mWHO criteria reflecting clinical experience with ipilimumab in which objective and durable responses (as per mWHO) were observed in participants following progression and without intervening alternative anti-cancer therapy. Immune-related (ir)Complete Response (irCR): Complete disappearance of all index lesions; ir Partial Response (irPR): Decrease, relative to baseline, of 50% or greater in sum of products of the two largest perpendicular diameters of all index and all new measurable lesions, in the absence of irCR; ir Stable Disease (irSD): Does not meet criteria for irCR or irPR, in the absence of progressive disease (PD); ir PD: At least 25% increase in Tumor Burden compared to sum of product diameters (SPD) at nadir. ir Unknown=participants overall response not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457344|NCT00796991|Secondary|Number of Participants in Best Overall Response Categories Based on Modified World Health Organization (mWHO) Criteria - All Treated Participants|Assessments for antitumor activity by physical exam and routine anatomic imaging were at Week 12 and confirmatory imaging at Weeks 16, 20, and 24. Participants with resected index or new lesions were considered progressed in their disease. Complete Response (CR): Complete disappearance of all index lesions; Partial Response (PR): Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions, in the absence of Complete Response; Stable Disease (SD): Does not meet criteria for complete or partial response, in the absence of progressive disease. Participants with PR or CR that was not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions; Progressive Disease: At least 25% increase in the sum of products of all index lesions and/or the appearance of any new lesion(s). Unknown=the participants overall response was not known.|Day 1 to Week 48|Treated participants received at least one dose of a study drug.|||participants|||Number
1457345|NCT00796991|Secondary|Pharmacokinetic Parameter Volume of Distribution at Steady State (Vss) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Vss reported in liters(L): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||L||Geometric Coefficient of Variation|Geometric Mean
1457346|NCT00796991|Primary|Area Under the Concentration Time Curve (AUC) From Time Zero to 21 Days [AUC(0-21d)] for Ipilimumab and AUC Time Zero Extrapolated to Infinity [AUC(INF)] for Paclitaxel, Dacarbazine and the Active Metabolite AIC - Pharmacokinetic Analysis Population|AUC=micrograms*hour(h) per mL (µg*h/mL): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1457371|NCT00796744|Secondary|The Rate of Re-epithelialization of the Ulcer Site.|The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.|12 weeks||||percent ulcer area re-epithelialized/wk||Standard Deviation|Mean
1457347|NCT00796991|Secondary|Pharmacokinetic Parameter of Clearance (CLT) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|CLT reported in milliliters/hour (mL/h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
1457348|NCT00796991|Secondary|Pharmacokinetic Parameter of Terminal Elimination Half Life (T-HALF) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|T(HALF) reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||h||Standard Deviation|Mean
1457349|NCT00796991|Secondary|Pharmacokinetic Parameter of Time of Maximum Observed Concentration (Tmax) for Ipilimumab, Paclitaxel, Dacarbazine and Active Metabolite AIC - Pharmacokinetic Analysis Population|Tmax reported in hours (h): derived from drug concentration versus time for ipilimumab (Day 43 only) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma ELISA; LLOQ=0.8 µg/mL; ULOQ=25.6 µg/mL; sample times on Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; starting Day 162 every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined from plasma using LC/MS/MS detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; sample times Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography API tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; sample times Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose..|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate PK profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||h||Full Range|Median
1457350|NCT00796991|Primary|Pharmacokinetic Parameter Maximum Observed Serum Concentration (Cmax) for Ipilimumab, Paclitaxel, Dacarbazine and the Active Metabolite for Dacarbazine, 5-aminoimidazole-4carboxamide (AIC)- Pharmacokinetic Analysis Population|Cmax=micrograms per milliliter (µg/mL): drug concentration versus time for ipilimumab (Day 43) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma by Enzyme-linked Immunosorbent Assay (ELISA); lower level of quantitation (LLOQ)=0.8 µg/mL; upper limit of quantitation (ULOQ)=25.6 µg/mL; Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; from Day 162 on every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined using liquid chromatography tandem mass spectrometry (LC/MS/MS) detection; LLOQ=10 nanograms per milliliter (ng/mL); ULOQ=5000 ng/mL; Day 1 and Day 43=0 h predose, 1.5, 3.0, 3.5, 5,5, 9.5, 24, 48 h postdose. Dacarbazine (DTIC) and AIC determined from plasma using liquid chromatography atmospheric pressure ionization (API) tandem mass spectrometry (LC-API/MS/MS) detection; LLOQ for dacarbazine=10.0 ng/mL; ULOQ=5000 ng/mL; AIC LLOQ=0.05 µg/mL; ULOQ=25.0 µg/mL; Day 1: 0 h predose, 1, 1.5, 2.5, 3.5, 5.5, 9.5, 24 h post dose.|Day 1 (0 h) to Day 43|N=participants who received study drug and with adequate Pharmacokinetic (PK) profiles. N is presented for each study drug in each category below. Day 1=paclitaxel/carboplatin or Day 1=dacarbazine; Day 43=ipilimumab+paclitaxel/carboplatin or Day 43=ipilimumab+dacarbazine.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1457351|NCT00796926|Secondary|Superior and Inferior Tear Meniscus Height|This is determined by anterior segment OCT visante system|6 weeks|||||||
1457352|NCT00796926|Secondary|Tear Osmolarity|This is measured by the TearLab (Ocusense) system|6 weeks|||||||
1457353|NCT00796926|Secondary|Meibography Grading||6 weeks|||||||
1457354|NCT00796926|Secondary|Schirmer I Reading||6 weeks|||||||
1457355|NCT00796926|Secondary|Tear Break Up Time (TBUT)||6 weeks|||||||
1457356|NCT00796926|Secondary|Corneal Fluorescein Staining Score|This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any|6 weeks|||||||
1457357|NCT00796926|Primary|Visual Analog Score (VAS)|Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum|6 weeks|intention to treat|||scores on a scale||Standard Deviation|Mean
1457358|NCT00796861|Primary|Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.|A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.|An average of every 6 weeks|No analyses were performed as none of the subjects made it through a full cycle.||||||
1457359|NCT00796822|Secondary|Change in Soluble TNF-Receptor I Levels|Measure of systemic inflammation|Measured at baseline and Week 8|Those who had both baseline and Week 8 data available|||pg/mL||Standard Deviation|Mean
1457360|NCT00796822|Primary|Change in Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.|Measured at baseline and Week 8|Number of remaining participants at week 8 with evaluable vascular ultrasonography. In the Pentoxifylline group, 10 participants were evaluated at week 8 but only 9 had evaluable ultrasonography.|||absolute percentage||Standard Deviation|Mean
1457361|NCT00796757|Secondary|EQ-5D - Visual Analog Scale (VAS)|EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1457362|NCT00796757|Secondary|Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.|Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1457363|NCT00796757|Secondary|OS - Time to Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||months||95% Confidence Interval|Median
1457364|NCT00796757|Secondary|OS - Percentage of Participants With an Event|OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants|||Number
1457365|NCT00796757|Secondary|Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months|OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.|Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants||95% Confidence Interval|Number
1457366|NCT00796757|Primary|PFS - Time to Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population|||months||95% Confidence Interval|Median
1457367|NCT00796757|Primary|PFS - Percentage of Participants With an Event|PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population|||percentage of participants|||Number
1457368|NCT00796757|Secondary|Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)|Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant|ITT population; only participants with measurable disease were included in the analysis.|||percentage of participants|||Number
1457369|NCT00796757|Primary|Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months|PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.|12 and 24 months|ITT population|||percentage of participants||95% Confidence Interval|Number
1457370|NCT00796744|Secondary|The Time to Re-epithelialization of the Ulcer Site.|Average time to complete re-epithelialization of baseline ulcer area.|24 weeks||||Weeks||Standard Error|Mean
1457375|NCT00796718|Secondary|Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 15 weeks (assessed 1 month after surgery)|Participants with available data.|||percentage of participants|||Number
1457376|NCT00796718|Secondary|Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)|Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.|Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)|Participants with available data.|||percentage of participants|||Number
1457377|NCT00796718|Primary|Percentage of Participants With Pathological Complete Response|Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.|Up to 11 weeks (assessed at the time of post-treatment surgery)|Participants with available data.|||percentage of participants|||Number
1457378|NCT00796705|Secondary|Participants With an ACR 70 Response at Week 12|"The American College of Rheumatology (ACR) 70 Responder Index is defined as someone who achieved at least 70% improvement in the tender and swollen 28- joint count, and 70% improvement in at least three of the following the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
1457379|NCT00796705|Secondary|Participants With an ACR 50 Response at Week 12|"The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
1457380|NCT00796705|Secondary|Participants With an ACR 20 Response at Week 12|"The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:~Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)~Patient's global assessment of disease activity (VAS 100 mm)~Physician's global assessment of disease activity (VAS 100 mm)~Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)~Acute phase reactant (CRP)"|Week 12|Intent-to-treat|||participants|||Number
1457381|NCT00796705|Secondary|Participants With a Decrease in Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value of >1.2 From Baseline to Week 12 (European League Against Rheumatism (EULAR) Definition of a Moderate Response)|The EULAR definition of a Moderate Response is a decrease from baseline in the DAS28[CRP] value of ≥ 1.2.|Baseline, Week 12|Intent-to-treat|||participants|||Number
1457382|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value < 2.6 (Remission) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat|||participants|||Number
1457383|NCT00796705|Secondary|Participants With a Disease Activity Score Using C-reactive Protein (DAS28[CRP]) Value <= 3.2 (Low Disease Activity) at Week 12|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Week 12|Intent-to-treat|||participants|||Number
1457384|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
1457385|NCT00796705|Primary|Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers.|The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).|Baseline, Week 12|Intent-to-treat|||Scores on a scale||Standard Deviation|Mean
1457488|NCT00796510|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)|The WHO functional classes of PAH range from Class 1 (no limitation in physical activity) to Class IV (can not perform a physical activity without any symptoms).|Baseline, Week 12 and ET (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.|||participants|||Number
1457386|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Physical Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457387|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental Health|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Composite Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457388|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Mental Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457389|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Emotional Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457390|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Social Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457391|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Vitality score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457392|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = General Health score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457393|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Bodily Pain score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457394|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Role Limitations Due to Physical Health Problems score at Week x minus score at baseline.|Baseline, Weeks 12, 24 or ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457395|NCT00796666|Secondary|Change in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning Domain|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change from baseline = Physical Functioning score at Week x minus score at baseline.|Baseline, Weeks 12, 24 and ET|ITT; N=number of participants analyzed|||units on a scale||Standard Deviation|Mean
1457408|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457396|NCT00796666|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48|WHO PAH Functional Classification of physical activity limitations: I (no limitation), II (slight limitation), III (marked limitations, comfortable at rest) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Worsened (functional class increased). The change from baseline in WHO functional class at Week X was summarized with frequency count and percentage in each category based on imputed data for missing values at Week X.|Baseline, Weeks 12, 24 or ET|ITT|||participant|||Number
1457397|NCT00796666|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change from baseline = score at Week x - score at baseline.|Baseline to Weeks 12 and 24|ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) method|||meters (m)||Standard Deviation|Mean
1457398|NCT00796666|Primary|Time to Clinical Worsening (TTCW)|Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured as duration between study’s first dose date in and date when first clinical worsening event occurs.|Baseline, Weeks 12, 24 or Early Termination (ET)|Intent-to-Treat population (ITT): all participants who were randomized|||Days||Full Range|Median
1457399|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
1457400|NCT00796653|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first study drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1457401|NCT00796653|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.|||percentage of participants|||Number
1457402|NCT00796653|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1457403|NCT00796653|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1457404|NCT00796653|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1457405|NCT00796653|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
1457406|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
1457407|NCT00796653|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.||||Days||95% Confidence Interval|Mean
1457520|NCT00796003|Secondary|Phase II: Median Time to Remission|Median time required for the participants to achieve remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.|||Days||95% Confidence Interval|Median
1457409|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457410|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457411|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457412|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457413|NCT00796653|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457414|NCT00796653|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457415|NCT00796653|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457416|NCT00796653|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457417|NCT00796653|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457418|NCT00796653|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS|||Number of puffs||Standard Error|Mean
1457419|NCT00796653|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS|||L/min||Standard Error|Mean
1457420|NCT00796653|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457421|NCT00796653|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457422|NCT00796653|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457423|NCT00796653|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457424|NCT00796653|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457425|NCT00796653|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1457426|NCT00796653|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1457427|NCT00796653|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1457428|NCT00796653|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1457545|NCT00795951|Primary|Diagnostic Performance: Carba Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457429|NCT00796653|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1457430|NCT00796653|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1457431|NCT00796653|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1457432|NCT00796653|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1457433|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457434|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457435|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457443|NCT00796653|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1457436|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457437|NCT00796653|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457438|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457439|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457440|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457441|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457442|NCT00796653|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457546|NCT00795951|Primary|Diagnostic Performance: Epoxy Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457444|NCT00796653|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1457445|NCT00796653|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1457446|NCT00796653|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1457447|NCT00796653|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1457448|NCT00796653|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1457449|NCT00796653|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1457450|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457451|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457452|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457453|NCT00796653|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457454|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457455|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457456|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457457|NCT00796653|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457458|NCT00796653|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457459|NCT00796653|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1457472|NCT00796614|Secondary|Change From Baseline in LPP at Week 14 (End of Treatment)|Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.|Baseline and Week 14|Full analysis set-LPP (FAS-LPP), OT|||cm H2O||Standard Error|Least Squares Mean
1457489|NCT00796510|Secondary|Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24|The walk distance was the total distance walked during the 6-minute test. Change is distance walked at week x minus distance walked at baseline.|Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)|Due to the premature termination only 3 participants were recruited into this study. No analyses were performed.|||meters||Standard Deviation|Mean
1457460|NCT00796653|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457461|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|73 hours to 6 weeks post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
1457462|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|49 to 72 hours post-operative|Data only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
1457463|NCT00796627|Primary|Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|0 to 24 hours post-operative|Data was only collected for the experimental arm for this outcome measure to assess the change in amount of CACs after burn injury as time progressed.|||cells per standard well||Full Range|Mean
1457464|NCT00796627|Primary|The Quantification of Circulating Angiogenic Cells in the Blood of Individuals Who Are Healthy Volunteers Compared to Those in Individuals Who Have Sustained a Burn Injury|Tissue samples were harvested from healthy volunteers and participants who sustained burns. CACs were isolated and counted under fluorescence microscopy.|baseline||||cells per standard well||Full Range|Mean
1457465|NCT00796614|Secondary|Post Void Residual Volume at Week 14|Median change from baseline to Week 14 in post void residual (mL) by study treatment.|Baseline and Week 14.|Treated Set (TS). Number of particiapants Analysed are the number of participants whose data were available for this endpoint.|||mL||Standard Deviation|Median
1457466|NCT00796614|Secondary|Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing.|"Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.~Relevant findings or worsening of baseline conditions were reported as adverse events."|From first drug administration until 28 days after last study drug administration, upto 160 days|"Treated Set (TS).~All subjects began treatment with their low dose and then they were titrated to their randomised medium or high dose. Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study."|||Participants|||Number
1457467|NCT00796614|Secondary|Change From Baseline in Number of Times Patient Was Wet at Catheterisation|Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH)|||Times patient wet at catheterization||Standard Error|Least Squares Mean
1457468|NCT00796614|Secondary|Change From Baseline in Urine Volume at Week 14|Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.|Baseline and Week 14|Full analysis set-catheter (FAS-CATH): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment, were on a catheterisation regimen, and had at least one on-treatment catheterisation assessment.|||mL||Standard Error|Least Squares Mean
1457469|NCT00796614|Secondary|Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline|"Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).~Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14."|Baseline and Week 14|Full analysis set-renal (FAS-RENAL)|||Participants|||Number
1457470|NCT00796614|Secondary|Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline|"Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.~The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization"|Baseline and Week 14|Full analysis set-renal (FAS-RENAL): This analysis set includes all patients in the treated set who received at least one dose of randomised treatment and had at least one on-treatment renal ultrasound measurement.|||Participants|||Number
1457471|NCT00796614|Secondary|Percentage Change From Baseline in LPP at Week 14 (End of Treatment)|Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.|Baseline and Week 14.|Full analysis set-LPP (FAS-LPP), OT|||Percentage change||Standard Error|Least Squares Mean
1457547|NCT00795951|Primary|Diagnostic Performance: P-tert Butylphenol Formadehyde Resin|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457473|NCT00796614|Primary|Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day.|The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.|Week 14|Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.|||Percentage of participants|||Number
1457474|NCT00796549|Secondary|Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status|"Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :~0 : Fully active, able to carry on all pre-disease performance without restriction.~: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.~: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.~: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.~: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.~: Dead.~Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included."|End Of Treatment, up until 190 weeks|Treated set (TS).|||percentage of participants|||Number
1457475|NCT00796549|Secondary|Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction|"Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.~There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF)."|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).|||percentage of participants|||Number
1457476|NCT00796549|Secondary|Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder|The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs.|First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks|Treated Set (TS).|||Percentage of participants|||Number
1457477|NCT00796549|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15)|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.|Day 15|"Pharmacokinetic set (PK set) contains all patients who received study medication and have evaluable pharmacokinetic parameter data.~Data from patients who received the starting dose of 50 mg afatinib and were still on treatment and not dose-reduced on Day 15 are presented."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1457478|NCT00796549|Secondary|Overall Survival (OS) Time|Overall survival time is defined as time from the date of start of treatment to the date of death.|Baseline until last vital status assessment 17JUN13|Treated set (TS).|||Weeks||95% Confidence Interval|Median
1457479|NCT00796549|Secondary|Progression Free Survival (PFS) Time|Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||Weeks||95% Confidence Interval|Median
1457480|NCT00796549|Secondary|Duration of Confirmed Disease Control|Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||Weeks||Standard Deviation|Mean
1457481|NCT00796549|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.|Every 8 weeks until last response assessment 28NOV12|Treated set (TS).|||percentage of participants||95% Confidence Interval|Number
1457482|NCT00796549|Secondary|Duration of Confirmed Objective Response (OR)|Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).|||Weeks||Standard Deviation|Mean
1457483|NCT00796549|Secondary|Number of Participants With Objective Response (OR) Categorized by Time|Cumulative number of participants with objective response by time points with responders.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS).|||percentage of participants|||Number
1457484|NCT00796549|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||percentage of participants||95% Confidence Interval|Number
1457485|NCT00796523|Primary|Hours Per Day of Sleep|mean sleep time is the mean of 3 daily sleep times reported in a time period.|week 8|Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis|||hours per day||Standard Deviation|Mean
1457486|NCT00796523|Primary|Hours Per Day of Fuss/Cry|total hours per day of fuss, cry, and unsoothable crying.|week 8|If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis|||hours per day||Standard Deviation|Mean
1457491|NCT00796419|Secondary|Ventilator-free Days|The ‘ventilator free survival days’ in a 30-day period is a previously validated method of comparing groups with respect to mechanical ventilator requirements while adjusting for mortality. This variable represents the number of days in the 30-day period following baseline that the patient is alive and not requiring mechanical ventilation.|Day 30||||days||Inter-Quartile Range|Median
1457492|NCT00796419|Secondary|Change in Oxygenation (PaO2/FiO2 Ratio)|Change in arterial oxygenation measured by arterial blood gas analysis. The partial pressure of O2 in arterial blood to fraction of inspired oxygen ratio (PaO2/FiO2) is a ratio of partial pressure arterial oxygen to fractional inspired inspired oxygen. This ratio is used as an indicator of hypoxemia (low blood oxygen). A PaO2/FiO2 ratio of 200-300 indicates mild ARDS, 100-200 indicates moderate ARDS, and less than 100 indicates severe ARDS.|Baseline, Day 1||||mmHg||Standard Deviation|Mean
1457493|NCT00796419|Primary|Change in Extravascular Lung Water (EVLW)|Quantity of extravascular lung water (EVLW) measured by transpulmonary thermodilution. Higher measurements of EVLW per kilogram of body weight indicate increased lung injury. Normal values for EVLW are thought to be less than 10 mL/kg.|Baseline to Day 5 (120 hours)||||mL/kg||Standard Deviation|Mean
1457494|NCT00796367|Primary|Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.||Baseline to End of Treatment|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent participants|||Number
1457495|NCT00796367|Primary|Percent Weight Change at End of Treatment, Week 108.||From baseline to end of treatment|Intent-to-Treat Last observation carried forward (ITT-LOCF)|||percent weight loss||Standard Error|Least Squares Mean
1457496|NCT00796328|Primary|Effective Dose of Phenylephrine at Which 90% of Subjects Have no Spinal Induced Hypotension|The effective dose at which 90% of subjects will have a “positive” response to a phenylephrine infusion, i.e. no spinal induced hypotension. We hypothesize that the ED90 will be between 40 – 60 mcg/min.|Spinal administration until delivery||||dose of phenylephrine|||Number
1457497|NCT00796315|Primary|Cmax of Doxylamine|Maximum concentration of Doxylamine from 0 to 72 hours post-dose|72 Hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1457498|NCT00796315|Primary|AUC of Doxylamine|Area under the time-concentration curve for Doxylamine from 0 to 72 hours post-dose plus an extrapolated area from 72 hours to infinity.|72 Hours||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1457499|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Severity of Illness|Using this clinician rating scale the severity of the illness is scored from 1= normal to 7= extremely ill. This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Severity of Illness scores are reported below.|Measured at endpoint visit|ADHD and severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Severity of Illness rating|||participants|||Number
1457500|NCT00796302|Other Pre-specified|Clinical Global Impressions Scale for Improvement|Using this clinician rating scale the patient's improvement is scored on a 7-point scale which ranges from “very much improved” (1), through “no change” (4), to “very much worse” (7). This scale was used at baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, & 9. Only endpoint (week 9 or subject's last visit) Clinical Global Impressions Scale for Improvement scores are reported below.|Measured at endpoint visit|ADHD & severe physical aggression; participants who completed a study endpoint visit and were given a Clinical Global Impressions Scale for Improvement rating|||participants|||Number
1457501|NCT00796302|Other Pre-specified|Antisocial Behavior Scale - Reactive Aggression Subscale|The Antisocial Behavior Scale (ABS) is a 28-item scale that contains 10 Proactive Aggression items and six Reactive Aggression items. Each item is rated on a 3-point scale, ranging from 1 (Never) to 3 (Very often). Thus, scores on the Reactive Aggression subscale can range from 6 through 18; with higher scores indicating more reactive aggression.|Measured at baseline and Week 9|ADHD & severe physical aggression|||units on a scale||Standard Deviation|Mean
1457502|NCT00796302|Primary|NCBRF-TIQ D-Total Score|"Parent ratings of aggression and hostility on the Nisonger Child Behavior Rating Form-Typical IQ (NCBRF-TIQ) D-Total Score. The NCBRF provides 1 prosocial subscale (Positive/Social) and 6 problem behavior subscales (Conduct Problem, Oppositional Behavior, Hyperactive, Inattentive, Overly Sensitive, and Withdrawn/Dysphoric). The NCBRF has excellent internal consistency, distinguishes between controls and subjects with DBDs. Conduct Problem and Oppositional Behavior subscales map closely to DSM-IV-TR symptoms of CD and ODD; they were scored together to form a variable called the D-Total.~For the NCBRF D-Total, higher scores reflect worse behavior. Each subscale is scored by taking the rating (0 [did not occur or was not a problem] to 3 [occurred a lot or was a very severe problem]) for all component items. The D-Total score was computed by adding the 6 scores from the Oppositional subscale and the 10 items from the Conduct Problem subscale. Thus D-Total scores could range from 0-69."|Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9|ADHD & severe physical aggression|||units on a scale||Standard Deviation|Mean
1457503|NCT00796224|Secondary|Adverse Events (AEs) and Serious AEs (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.|Baseline up to 28 days|All subjects who received at least 1 dose of study medication were included in the safety analyses.|||participants|||Number
1457504|NCT00796224|Secondary|Number of Participants With a Clinical Response|"Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following:~Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary;~New clinical signs and symptoms of acute illness have developed and additional therapy is necessary"|Days 7,8,9 or 10|Any worsening of existing signs and symptoms, or new signs and symptoms, were documented as adverse events.|||participants|||Number
1457505|NCT00796224|Secondary|Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)||1,2,3,4,8,24,48,72 hours postdose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/ml|||Number
1457548|NCT00795951|Primary|Diagnostic Performance: Cobalt Dichloride|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457506|NCT00796224|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin|Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||hr||Full Range|Median
1457507|NCT00796224|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azithromycin||Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/ml||Standard Deviation|Mean
1457508|NCT00796224|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)|AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng*hr/ml||Standard Deviation|Mean
1457509|NCT00796224|Primary|Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)|AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.|Predose/0 to 72 Hours|All subjects randomized and treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng*hr/ml||Standard Deviation|Mean
1457510|NCT00796120|Secondary|Duration of Response (DOR)|The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.|Up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||days||95% Confidence Interval|Median
1457511|NCT00796120|Secondary|Overall Survival|Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.|Baseline up to End of Study (an average of 4 years)|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||months||95% Confidence Interval|Median
1457512|NCT00796120|Secondary|Percentage of Participants With Objective Response|Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.|Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||percentage of participants||95% Confidence Interval|Number
1457513|NCT00796120|Secondary|6-month Progression - Free Survival|Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.|6 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of TRS.|||percentage of participants||95% Confidence Interval|Number
1457514|NCT00796120|Primary|Progression - Free Survival (PFS)|The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.|Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months|Efficacy population included all participants randomly assigned to either treatment arm with externally confirmed pathological and molecular diagnosis of translocation-related sarcomas (TRS)|||months||95% Confidence Interval|Median
1457515|NCT00796003|Secondary|Phase II: Number of Participants With Cytogenic Response - as Per International Working Group (IWG) Response Criteria 2000 (Major/Minor) and IWG 2006 (Complete/Partial)|IWG 2000 - Major: disappearance of cytogenetic abnormality; Minor: 50% or more reduction in abnormal metaphases. IWG 2006 - Complete: disappearance of the chromosomal abnormality without appearance of new ones; Partial: At least 50% reduction of the chromosomal abnormality.|Up to 1.5 years after the last participant enrolled|20 participants who had chromosomal abnormality were evaluated in Phase II for cytogenetic response. The IWG criteria requires 20 analyzable metaphases using conventional cytogenetic techniques.|||Participants|||Number
1457516|NCT00796003|Secondary|Phase II: Overall Improvement Rate: Number of Participants Who Achieved Complete Response (CR)+Partial Response (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes. HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 1.5 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this set|||Participants|||Number
1457517|NCT00796003|Secondary|Phase II: Median Duration of Overall Improvement|Median time duration for which participants achieved overall improvement (complete remission+partial remission+hematologic improvement).|Up to 1.5 years after the last participant enrolled|14 participants who achieved overall improvement were evaluated.|||Days||Full Range|Median
1457518|NCT00796003|Secondary|Phase II: Median Duration of Remission|Median time duration for which participants achieved remission (complete remission+partial remission).|Up to 1.5 years after the last participant enrolled|9 participants who achieved remission were evaluated.|||Days||Full Range|Median
1457521|NCT00796003|Secondary|Phase I: Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR)+Hematological Improvement (HI) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations (mCR) show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia; PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes; HI: hemoglobin < 11 g/dL (erythroid); platelet < 100,000/mL; neutrophils < 1,000/mL.|Up to 28 Days of treatment Cycle 1|Full Analysis Set (FAS): 9 participants were included in this set for Phase I|||Participants|||Number
1457522|NCT00796003|Secondary|Phase I: Area Under the Plasma Concentration-time Curve (AUC)|Area under the curve from time zero to extrapolated infinite time (AUC Infinity) and area under the curve from time zero to last quantifiable concentration (AUC Last).|Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis|||ng*h/mL||Standard Deviation|Mean
1457523|NCT00796003|Secondary|Phase I: Maximum Observed Plasma Concentration of Decitabine (Cmax)||Before dosing (Pre-dose), 30 min, 60 min (end of infusion), 65 min, 75 min, 90 min, 120 min, 180 min, 240 min after the start of decitabine infusion on Day 1 and Day 5 of 28-Days Cycle 1|Pharmacokinetic Population: 8 participants were evaluated for pharmacokinetic analysis|||ng/mL||Standard Deviation|Mean
1457524|NCT00796003|Primary|Phase I and II: Number of Participants Who Experienced Adverse Events||Up to 1.5 years after the last participant enrolled|Safety Population: 9 participants in Phase I and 34 participants in Phase II were evaluated for safety|||Participants|||Number
1457525|NCT00796003|Primary|Phase II: Overall Remission Rate (ORR): Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria (2000)|IWG response criteria (2000) - CR: bone marrow evaluations show < 5% blasts; no dysplasia; normal maturation of all cell lines and peripheral blood shows hemoglobin ≥ 11 g/dL; neutrophils ≥ 1,500/mL; platelets ≥ 100,000/mL; 0% blasts; no dysplasia and PR: same as CR, except blasts decrease by ≥ 50% or lower French-American-British (FAB) classification of Myelodysplastic Syndromes.|Up to 1 years after the last participant enrolled|Full Analysis Set (FAS): 34 participants were included in this analysis set for Phase II|||Participants|||Number
1457526|NCT00795951|Secondary|Itching/Burning|Number of subjects who presented with itching/burning at patch removal|Day 2: 48 hours after patch application||||participants|||Number
1457527|NCT00795951|Secondary|Adhesion|Number of subjects who presented with poor adhesion at patch removal|Day 2: 48 hours after application||||participants|||Number
1457528|NCT00795951|Secondary|Irritation|Number of subjects who presented with irritation at patch removal|Visit 2: 48 hours after patch application||||participants|||Number
1457529|NCT00795951|Secondary|Persistent Reactions|Number of subjects who presented with persistent reactions|appear 2-4 days after patch application and last through 7-14 days after application||||participants|||Number
1457530|NCT00795951|Secondary|Late Reactions|Number of subjects who presented with late reactions|7-10 days after patch application||||participants|||Number
1457531|NCT00795951|Primary|Diagnostic Performance: Quinoline Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457532|NCT00795951|Primary|Diagnostic Performance: Tixocortol-21-pivalate|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457533|NCT00795951|Primary|Diagnostic Performance: Budesonide|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457534|NCT00795951|Primary|Diagnostic Performance: Imidazolidinyl Urea|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457535|NCT00795951|Primary|Diagnostic Performance: Diazolidinyl Urea|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457536|NCT00795951|Primary|Diagnostic Performance: Thiuram Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457537|NCT00795951|Primary|Diagnostic Performance: Thimerosal|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457538|NCT00795951|Primary|Diagnostic Performance: Mercapto Mix|Number of subjects with positive reactions at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457539|NCT00795951|Primary|Diagnostic Performance: Formaldehyde|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457540|NCT00795951|Primary|Diagnostic Performance: p-Phenylenediamine|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457541|NCT00795951|Primary|Diagnostic Performance: Mercaptobenzothiazole|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457542|NCT00795951|Primary|Diagnostic Performance: Quaternium-15|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457543|NCT00795951|Primary|Diagnostic Performance: Cl+Me-Isothiazolinone|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457544|NCT00795951|Primary|Diagnostic Performance: Black Rubber Mix|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application||||participants|||Number
1457558|NCT00795951|Primary|Diagnostic Performance: Neomycin Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|The prevalence of allergic contact dermatitis varies greatly (≤1%-10%) in consecutive subjects. Therefore, estimates of sample size and study power are based on overall AE rates, which are generally similar across populations and test allergens and for which there is relevant historical data.|||participants|||Number
1457559|NCT00795951|Primary|Diagnostic Performance: Nickel Sulfate|Number of subjects with positive reactions recorded at visit 3 or visit 4|Visit 3: 72 hours after patch application, Visit 4: 1 week after patch application|All completed subjects were included in the efficacy analysis.|||participants|||Number
1457560|NCT00795886|Primary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation. The Kaplan-Meier product limit method was used to compute the probability of overall survival to 2 years. Greenwood's formula was used to compute the standard error.|24 months after transplant|All patients enrolled in study.|||probability||Standard Error|Mean
1457561|NCT00795886|Secondary|Percentage of Patients Developing Acute Graft vs. Host Disease (GVHD)|Cumulative incidence of Grade 2-4 acute GVHD at 180 days.|180 days||||percentage of participants||95% Confidence Interval|Number
1457562|NCT00795886|Primary|Number of Participants With Transplant-related Mortality|Death not associated with relapse. We determined that if transplant related mortality(TRM) 25% at day 100 or if Grade III-IV (severe, life threatening, or disabling) acute GVHD was >30% a stopping rule would be triggered.|24 months after transplant|All participants enrolled in the trial.|||participants|||Number
1457563|NCT00795821|Secondary|Pharmacokinetic (PK) Parameter: Plasma Concentration of LY2216684|Blood samples collected from participants that received LY2216684 were measured to determine the plasma LY2216684 concentrations.|Baseline through Week 62|N=number of participants analyzed (N=365); n=number of plasma LY2216684 concentration observations. The sum of the individual ‘n’ values for each dose group does not equal 365 since the same participant could have received various doses during his/her participation in the study.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
1457564|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Supine Pulse at Week 62|Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1457565|NCT00795821|Secondary|Mean Change From Baseline in Supine Pulse at Week 10|Pulse was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1457566|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Supine Systolic and Diastolic Blood Pressure at Week 62|Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
1457567|NCT00795821|Secondary|Mean Change From Baseline in Supine Systolic and Diastolic Blood Pressure at Week 10|Blood pressure was collected while the participant was in the supine position. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
1457568|NCT00795821|Secondary|Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 62|"C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a yes answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a yes answer to actual attempt or completed suicide."|Baseline (Week 10) through Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
1457569|NCT00795821|Secondary|Percentage of Participants With Suicidal Ideation, Behavior, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 10|"C-SSRS scale captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal ideation, behavior, and acts were provided. Suicidal ideation=a yes answer to any 1 of 5 suicidal ideation questions (including wish to be dead) and 4 different categories of active suicidal ideation. Suicidal behavior=a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal act=a yes answer to actual attempt or completed suicide."|Baseline through Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline C-SSRS value.|||percentage of participants|||Number
1457570|NCT00795821|Secondary|Percentage of Participants Reporting Resource Utilization at Week 62|The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.|Baseline (Week 10) through Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||percentage of participants|||Number
1457571|NCT00795821|Secondary|Percentage of Participants Reporting Resource Utilization at Week 10|The Resource Utilization form assessed the frequency and type of medical services that participants have used within the last year, or since the last visit. Resources reported by at least 5% of participants in either treatment group were provided.|Baseline through Week 10|The analysis population included all randomized participants.|||percentage of participants|||Number
1457572|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 62|The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457573|NCT00795821|Secondary|Mean Change From Baseline in the Visual Analogue Scale for Fatigue (VAS-F) Overall Severity and Interference With Daily Activities Scores at Week 10|The VAS-F was a self-rated assessment with 2 items. For the Overall Severity of Fatigue item, the participant placed a vertical mark on a 100-millimeter (mm) line between 2 anchors (0=not at all to 100=as severe as I can imagine). For the Interference With Daily Activities Due to Fatigue item, the participant placed a vertical mark on a 100 mm line between 2 anchors (0=not at all to 100=complete disability [unable to do any activities]). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457574|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Brief Fatigue Inventory (BFI) Global Total Score at Week 62|The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its “worst,” “usual,” and “now” during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant’s life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457575|NCT00795821|Secondary|Mean Change From Baseline in the Brief Fatigue Inventory (BFI) Global Total Score at Week 10|The BFI was a participant-rated scale consisting of 9 items: 3 items assessed severity of fatigue at its “worst,” “usual,” and “now” during normal waking hours: 0=no fatigue to 10=fatigue as bad as you can imagine; 6 items assessed the degree to which fatigue has interfered with different aspects of the participant’s life during the past 24 hours: 0=does not interfere to 10=completely interferes. The BFI Global Total Score was the mean of the 9 item scores and ranged from 0 to 10. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457576|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457577|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Impact Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Impact Average Score=mean of Items 8-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457578|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1-5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457579|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Fatigue Experience Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Fatigue Experience Average Score=mean of Items 1 to 5, and 7. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457619|NCT00795600|Secondary|Absolute Change in Creatine Phosphokinase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatine Phosphokinase at week 26.|||IU/L||Standard Deviation|Mean
1457580|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 62|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457581|NCT00795821|Secondary|Mean Change From Baseline in the Fatigue Associated With Depression (FAsD) Patient Reported Outcome (PRO): Average Score at Week 10|The FAsD was a participant-rated scale with 7 items that asked how often they experience different aspects of fatigue: responses from 1 (Never) to 5 (Always); 9 items that asked how often fatigue impacts various aspects of their lives: responses from 1 (Not at all) to 5 (Very much). Average Score=mean of Items 1-5, 7-12, 14, and 16. Scores ranged from 1 to 5. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457582|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 62|EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, mood. Single score between 1 and 3 was generated for each domain. For each participant, outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457583|NCT00795821|Secondary|Mean Change From Baseline in the EuroQol Questionnaire-5 Dimension (EQ-5D) United States (US) Index Score at Week 10|EQ-5D was a generic, multidimensional, health-related, quality of life (Qol) instrument allowing participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457584|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 62|The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457585|NCT00795821|Secondary|Mean Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) at Week 10|The CPFQ was a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assessed motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item was scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent); total score ranged from 7 to 42. Least Squares (LS) Means were adjusted for treatment, investigator, and baseline score.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457586|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 62|The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457587|NCT00795821|Secondary|Mean Change From Baseline in the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) at Week 10|The QIDS-SR16 was a 16-item participant-rated measure of depressive symptomatology. The total score ranged from 0 to 27, with higher scores indicative of greater severity. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all participants with a baseline and at least 1 post-baseline value in the Per Protocol population, defined as the subset of randomized participants who had baseline and post-baseline data collected using the correct version of the QIDS-SR16 worksheet.|||units on a scale||Standard Error|Least Squares Mean
1457588|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 62|CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for investigator, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457620|NCT00795600|Secondary|Absolute Change in Creatinine||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Creatinine at week 26.|||mg/dL||Standard Deviation|Mean
1457589|NCT00795821|Secondary|Mean Change From Baseline in Clinical Global Impressions of Severity (CGI-Severity) Scale at Week 10|CGI-S measured severity of depression at the time of assessment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457590|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 62|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457591|NCT00795821|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment at Week 10|The SDS was completed by the participant and used to assess the effect of the participant's symptoms on their work/social/family life. Total of these 3 items=Global Functional Impairment score; scores ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457592|NCT00795821|Secondary|Mean Change From Baseline (Week 10) in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 62|The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for investigator, visit, baseline score, and baseline-by-visit.|Baseline (Week 10), Week 62|The analysis population included all participants in the Long-term Extension Phase with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457593|NCT00795821|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) at Week 10|The MADRS measured severity of depressive mood symptoms. The 10-item checklist rating scale was 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Means were adjusted for treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|Baseline, Week 10|The analysis population included all randomized participants with a baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1457594|NCT00795769|Primary|Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)|Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.|Baseline up to 120 minutes||||Participants|||Count of Participants
1457595|NCT00795717|Secondary|Brachial Artery Reactivity|"To demonstrate the impact of omega-three fatty acid intake on BART (Brachial Artery Reactivity Test) at 12 weeks.~Brachial artery ultrasound measurements Brachial artery reactivity will be assessed by ultrasound and FMD will be calculated as the change in brachial artery diameter after release of suprasystolic blood pressure cuff inflation. A blood pressure cuff will be inflated on the upper arm to induce increase in blood flow, termed reactive hyperemia, which increases arterial diameter. The change in vessel diameter is determined by high-resolution ultrasound imaging. The endothelium-dependent FMD of the brachial artery is quantified as the maximum percent change in arterial diameter, expressed in units of % of brachial artery."|12 weeks||||% of brachial artery diameter||Standard Deviation|Mean
1457596|NCT00795717|Secondary|Serum HDL Level||12 weeks||||mg/dl||Standard Deviation|Mean
1457597|NCT00795717|Primary|Change in Baseline Mean Serum Triglyceride Level at Study End|Change in Baseline (time 0) Mean Serum Triglyceride levels after 12 weeks of treatment or placebo|Baseline and 12 weeks|Randomized, cross over design|||mg/dl||Standard Deviation|Mean
1457598|NCT00795704|Secondary|Change From Baseline in Self-Monitoring Blood Glucose (SMBG) Averages|2-hour postprandial SMBG reported. A negative value indicates a decrease from baseline. A positive value indicates an increase from baseline.|Baseline and 3 months|Intention-to-treat with data submitted baseline and final.|||mg/dL||Standard Deviation|Mean
1457599|NCT00795704|Secondary|Number of Participants With Adverse Drug Reactions, Abnormal Metabolic Panel Levels, or Abnormal Liver Enzyme Levels|Sodium (>150 mmol/L), Potassium (>5 mmol/L), Bicarbonate (>34 mmol/L), Chloride (>110 mmol/L), Serum Creatinine (>1.2 mg/dL), Blood Urea Nitrogen (24 mg/dL), Calcium (>11 mg/L), Alanine Aminotransferase (>3 times baseline), Aspartate Aminotransferase (>3 times baseline) were collected at baseline, 1 month, and 3 months. Self-Reported adverse drug reactions are also reported.|Baseline, 1 month, and 3 months||||participants|||Number
1457600|NCT00795704|Primary|Hemoglobin A1C||3 month minus baseline|intention-to-treat|||percent||Standard Deviation|Mean
1457601|NCT00795639|Secondary|Time to Clinical Worsening (TTCW)|TTCW defined as the number of days between first dose of study drug and the occurrence of a predefined clinical worsening event. Predefined clinical worsening events included: hospitalization for worsening PAH, on-study death, heart-lung or lung transplant, atrial septostomy or withdrawal due to the addition of any chronic medications for the treatment of worsening PAH.|Baseline, Weeks 4, 8 and 12 or ET|ITT; N=number of participants with analyzable data|||days||Full Range|Median
1457602|NCT00795639|Secondary|Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Classification at Weeks 4, 8 and 12|WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Improvement = reduction in functional class, deterioration = increase in functional class, no change = no change in functional class.|Baseline, Weeks 4, 8 and 12 or Early Termination (ET)|ITT; N=number of participants with analyzable data; n=number of participants with analyzable data at the specific time point|||participants|||Number
1457603|NCT00795639|Primary|Change From Baseline in Total Distance Walked During 6 Minute Walk Distance (6MWD) at Week 12|6 MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Change is Week 12 results minus baseline results.|Baseline/Day 1 and Week 12|Intent to treat population (ITT): all participants who were randomized; missing value at Week 12 imputed with last non-missing value, including the non-missing value obtained at early termination based on last observation carried forward (LOCF)|||Meters (m)||Full Range|Median
1457604|NCT00795600|Secondary|Number of Non-serious Adverse Events|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.|||events|||Number
1457605|NCT00795600|Secondary|Number of Hypoglycaemic Episodes|Number of episodes reported during the trial.|Weeks 0-26|Full analysis set is all randomised subjects who were exposed at least one dose of the trial product.|||episodes|||Number
1457606|NCT00795600|Secondary|Absolute Change in PAI-1 (Plasminogen Activator Inhibitor-1)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects from the Insulin Detemir group and one subject from the Insulin NPH group did not show a PAI-1 available value at week 0. Three subjects from each treatment group did not present a PAI-1 available value at week 26.|||ng/L||Standard Error|Least Squares Mean
1457607|NCT00795600|Secondary|Absolute Change in hsCRP (Highly Sensitive C Reactive Protein)|Absolute change in hsCRP was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and hsCRP at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject from each treatment group did not present a hsCRP available value at week 0. Two subjects from the Insulin Detemir group and three subjects from the Insulin NPH group did not show a hsCRP available value at week 26.|||mg/L||Standard Error|Least Squares Mean
1457608|NCT00795600|Secondary|Absolute Change in Hip Circumference|Absolute Change in Hip Circumferences was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex, and Metformin use as fixed factors, and hip circumference at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in hip circumference at week 26.|||cm||Standard Error|Least Squares Mean
1457609|NCT00795600|Secondary|Absolute Change in Waist Circumference|Absolute change in waist circumference was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and Waist at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in waist circumference at week 26.|||cm||Standard Error|Least Squares Mean
1457610|NCT00795600|Secondary|Absolute Change in Body Weight|Absolute change in body weight was based on ANCOVA model for absolute change from week 0 to week 26 as response variable with treatment, sex and Metformin use as fixed factors, and body weight at week 0 as covariable.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in body weight at week 26.|||kg||Standard Error|Least Squares Mean
1457611|NCT00795600|Secondary|Absolute Change in Potassium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Potassium at week 26.|||mmol/L||Standard Deviation|Mean
1457612|NCT00795600|Secondary|Absolute Change in Sodium||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in Sodium at week 26.|||mmol/L||Standard Deviation|Mean
1457613|NCT00795600|Secondary|Absolute Change in Alkaline Phosphatase||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. One subject in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the Alkaline Phosphatase at week 26.|||IU/L||Standard Deviation|Mean
1457614|NCT00795600|Secondary|Absolute Change in Aspartate Aminotransferase (ASAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ASAT at week 26.|||IU/L||Standard Deviation|Mean
1457615|NCT00795600|Secondary|Absolute Change in Alanine Aminotransferase (ALAT)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the ALAT at week 26.|||IU/L||Standard Deviation|Mean
1457616|NCT00795600|Secondary|Absolute Change in Bilirubin Total||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Bilirubin Total at week 26.|||mg/dL||Standard Deviation|Mean
1457617|NCT00795600|Secondary|Absolute Change in Albumin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group did not present an albumin baseline value and another two at week 26 and four subjects in the Insulin NPH group did not present a value in the albumin at week 26.|||mg/dL||Standard Deviation|Mean
1457618|NCT00795600|Secondary|Absolute Change in Urea||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the Urea at week 26.|||mg/dL||Standard Deviation|Mean
1457621|NCT00795600|Secondary|Absolute Change in Basophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||10^9 cells/L||Standard Deviation|Mean
1457622|NCT00795600|Secondary|Absolute Change in Eosinophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||10^9 cells/L||Standard Deviation|Mean
1457623|NCT00795600|Secondary|Absolute Change in Neutrophils||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. The comparison between visits could only be done with nine subjects in the Insulin Detemir group since only these patients had values available at week 0 and at week 26 while this applied to 22 subjects in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1457624|NCT00795600|Secondary|Absolute Change in Monocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Monocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1457625|NCT00795600|Secondary|Absolute Change in Lymphocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subject in the Insulin Detemir group presented values at week 26 in Lymphocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1457626|NCT00795600|Secondary|Absolute Change in Leucocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Leucocytes at week 26.|||10^9 cells/L||Standard Deviation|Mean
1457627|NCT00795600|Secondary|Absolute Change in Erythrocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in Erythrocytes at week 26.|||percentage||Standard Deviation|Mean
1457628|NCT00795600|Secondary|Absolute Change in Thrombocytes||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Only one subjects in the Insulin Detemir group presented values at week 26 in thrombocytes, whilst no subjects showed available values at week 26 in the Insulin NPH group.|||percentage||Standard Deviation|Mean
1457629|NCT00795600|Secondary|Absolute Change in Blood Volume (Haematocrit)||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the Haematocrit at week 26.|||percentage||Standard Deviation|Mean
1457630|NCT00795600|Secondary|Absolute Change in Haemoglobin||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the haemoglobin at week 26.|||g/dL||Standard Deviation|Mean
1457631|NCT00795600|Secondary|Absolute Change in Free Fatty Acids||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the free fatty acids at week 26.|||mg/dL||Standard Deviation|Mean
1457632|NCT00795600|Secondary|Absolute Change in Triglycerides||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and six patients in the Insulin NPH group did not present a value in the triglycerides at week 26.|||mg/dL||Standard Deviation|Mean
1457633|NCT00795600|Secondary|Absolute Change in Very Low Density Lipoprotein (VLDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three patients in the Insulin Detemir group and seven patients in the Insulin NPH group did not present a value in the VLDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1457634|NCT00795600|Secondary|Absolute Change in Low Density Lipoprotein (LDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the LDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1457635|NCT00795600|Secondary|Absolute Change in High Density Lipoprotein (HDL) Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the HDL cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1457636|NCT00795600|Secondary|Absolute Change in Total Cholesterol||Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Three subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the total cholesterol at week 26.|||mg/dL||Standard Deviation|Mean
1457637|NCT00795600|Secondary|Absolute Change in Adiponectin|Absolute change in adiponectin as response variable with treatment, sex and Metformin use as fixed factors, and Adiponectic at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Six subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the adiponectin at week 26.|||mcg/dL||Standard Error|Least Squares Mean
1457662|NCT00795535|Primary|SDNN: Standard Deviation of the Normal-to-normal R-R Interval|A determination of HRV derived from the time domain of a standard electrocardiogram, primarily determined by measuring the randomness of the exact occurrence of when one R wave follows a preceding R wave.|Upon arrival to the hospital||||milliseconds (ms)||Standard Deviation|Mean
1457638|NCT00795600|Secondary|Absolute Change in Fasting Plasma Glucose (FPG)|Absolute Change in Fasting Plasma Glucose as response variable with treatment, sex and Metformin use as fixed factors, and Fasting Plasma Glucose at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and six subjects in the Insulin NPH group did not present a value in the fasting plasma glucose at week 26.|||mg/dL||Standard Error|Least Squares Mean
1457639|NCT00795600|Secondary|Absolute Change in HbA1c (Glycosylated Haemoglobin)|Absolute Change in HbA1c as response variable with treatment, sex and Metformin use as fixed factors, and HbA1c at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the hbA1c at week 26.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
1457640|NCT00795600|Secondary|Percentage Change in Liver/Spleen Attenuation Ratio|Percentage Change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver to Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.|||percent change||Standard Error|Least Squares Mean
1457641|NCT00795600|Secondary|Absolute Change in Liver/Spleen Attenuation Ratio|Absolute change in Liver/Spleen Attenuation Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Liver/Spleen Attenuation Ratio at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and four subjects in the Insulin NPH group did not present a value in the liver to spleen attenuation ratio at week 26.|||ratio||Standard Error|Least Squares Mean
1457642|NCT00795600|Secondary|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Percentage Change in Calculated Visceral/Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.|||percent change||Standard Error|Least Squares Mean
1457643|NCT00795600|Secondary|Absolute Change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio|Absolute change in Calculated Visceral/Subcutaneous Adipose Tissue Ratio as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Visceral/Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated Visceral /Subcutaneous adipose tissue ratio at week 26.|||ratio||Standard Error|Least Squares Mean
1457644|NCT00795600|Secondary|Percentage Change in Subcutaneous Adipose Tissue Area|Percentage Change in Subcutaneous Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Subcutaneous Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.|||percent change||Standard Error|Least Squares Mean
1457645|NCT00795600|Secondary|Absolute Change in Subcutaneous Adipose Tissue Area|Absolute change in subcutaneous adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and subcutaneous adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the subcutaneous adipose tissue area at week 26.|||cm^2||Standard Error|Least Squares Mean
1457646|NCT00795600|Secondary|Percentage Change in Visceral Adipose Tissue Area|Percentage Change in Visceral Adipose Tissue Area as response variable with treatment, sex and Metformin use as fixed factors, and Visceral Adipose Tissue Area at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.|||percent change||Standard Error|Least Squares Mean
1457647|NCT00795600|Secondary|Absolute Change in Visceral Adipose Tissue Area|Absolute change in visceral adipose tissue area as response variable with treatment, sex and Metformin use as fixed factors, and visceral adipose tissue area at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the visceral adipose tissue area at week 26.|||cm^2||Standard Error|Least Squares Mean
1457648|NCT00795600|Secondary|Percentual Change in Calculated Trunk Fat Percentage|Percentual Change in Calculated Trunk Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Trunk Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.|||percent change||Standard Error|Least Squares Mean
1457649|NCT00795600|Secondary|Absolute Change in Calculated Trunk Fat Percentage|Absolute change in calculated trunk fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated trunk fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated trunk fat percentage at week 26.|||percent of trunk fat (%)||Standard Error|Least Squares Mean
1457650|NCT00795600|Secondary|Percentual Change in Calculated Whole Body Fat Percentage|Percentual Change in Calculated Whole Body Fat Percentage as response variable with treatment, sex and Metformin use as fixed factors, and Calculated Whole Body Fat Percentage at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.|||percent change||Standard Error|Least Squares Mean
1457651|NCT00795600|Secondary|Absolute Change in Calculated Whole Body Fat Percentage|Absolute change in calculated whole body fat percentage as response variable with treatment, sex and Metformin use as fixed factors, and calculated whole body fat percentage at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the calculated whole body fat percentage at week 26.|||percent of whole body fat (%)||Standard Error|Least Squares Mean
1457652|NCT00795600|Secondary|Percentage Change in Trunk Lean Mass|Percentage Change in Trunk Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and Trunk Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.|||percent change||Standard Error|Least Squares Mean
1457653|NCT00795600|Secondary|Absolute Change in Trunk Lean Mass|Absolute change in trunk lean mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk lean mass at week 0 as covariate|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk lean mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1457654|NCT00795600|Secondary|Percentage Change in Whole Body Lean Mass|Percentage Change in Whole Body Lean Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Lean Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.|||percent change||Standard Error|Least Squares Mean
1457655|NCT00795600|Secondary|Absolute Change in Whole Body Lean Mass|Absolute change in whole body lean mass as response variable with treatment, sex and Metformin use as fixed factors, whole body lean mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body lean mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1457656|NCT00795600|Secondary|Percentage Change in Whole Body Fat Mass|Percentage Change in Whole Body Fat Mass as response variable with treatment, sex and Metformin use as fixed factors, and whole Body Fat Mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.|||percent change||Standard Error|Least Squares Mean
1457657|NCT00795600|Secondary|Absolute Change in Whole Body Fat Mass|Absolute change in whole body fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|Week 0, week 26|Intention-To-Treat (ITT) analysis set is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in whole body fat mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1457658|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.|||grams (g)||Standard Error|Least Squares Mean
1457659|NCT00795600|Primary|Absolute Change in Trunk Fat Mass|Absolute change in trunk fat mass as response variable with treatment, sex and Metformin use as fixed factors, and trunk fat mass at week 0 as covariate.|week 0, week 26|ITT analysis set using LOCF is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.|||grams (g)||Standard Error|Least Squares Mean
1457660|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Per protocol (PP) population: All randomised and exposed subjects who completed the 26-week treatment without significantly deviating from the inclusion/exclusion criteria and the withdrawal criteria or other aspects of the protocol considered to potentially affect the efficacy results. Compared to the ITT population, two subjects were excluded.|||percent change||Standard Error|Least Squares Mean
1457661|NCT00795600|Primary|Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio)|Percentage of change of trunk fat mass as the dependent variable, baseline value (trunk fat mass at week 0) as covariate, treatment with metformin (yes/no) and gender (male/female) as effect and the treatment received (insulin detemir/insulin NPH) as the main factor.|week 0, week 26|Intention-To-Treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects exposed to at least one dose of the trial product. Two subjects in the Insulin Detemir group and three subjects in the Insulin NPH group did not present a value in the change in trunk fat mass at week 26.|||percent change||Standard Error|Least Squares Mean
1457663|NCT00795535|Primary|Life Saving Intervention in the Operating Room.|A patient was classified as having a life saving intervention in the operating room when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
1457664|NCT00795535|Primary|Serious Injury|A patient was classified as seriously injured when two of three blinded trauma surgeons classified the patient as similar after review of each patient chart and final diagnoses in retrospect.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
1457665|NCT00795535|Primary|Base Deficit </= -6|Indicator for volume deficit and resuscitation. Number of participants with Base Deficit </= -6 is reported. Base deficit is the absolute difference of the base deficit from its normal range (-2 to 2), and is used as an indicator for traumatic injuries. A base deficit </= - 6 signifies volume deficit and the need for volume resuscitation with fluids, blood or blood products either alone or in combination.|Upon arrival to the hospital|75 patients with complete HRV and trauma registry data|||participants|||Number
1457666|NCT00795509|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.|||participants|||Number
1457667|NCT00795509|Primary|Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|52 weeks|Safety analysis population included all enrolled participants who had received at least 1 confirmed, administration of Detorsitol.|||participants|||Number
1457668|NCT00795366|Primary|Time ICP >20|The number of hours that participants remained with intracranial pressure above 20 mmHg|The number of hours during the first 5 days of intracranial pressure monitoring|Intent-to-Treat|||Hours||Standard Deviation|Mean
1457669|NCT00795340|Secondary|Objective Tumor Response as Assessed by RECIST Criteria v1.1.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|Every 6 weeks at the end of every 2 cycles during protocol treatment and every 12 weeks after protocol treatment until progression.|ITT|||percentage of participants||95% Confidence Interval|Number
1457670|NCT00795340|Secondary|Progression-free Survival|Medians of PFS and their confidence intervals by arm|at every 3 months visit throughout trial, a median of 12 months|ITT|||months||95% Confidence Interval|Median
1457671|NCT00795340|Primary|Overall Survival|Medians of survival time, and their confidence intervals.|at every 3 months visit throughout trial, a median of 13.1 months.|ITT|||months||95% Confidence Interval|Median
1457672|NCT00795288|Secondary|Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk|Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.|7-10 days after hemorrhage||||ratio||Standard Deviation|Mean
1457673|NCT00795288|Primary|Cerebral Autoregulation During Peak Period of Vasospasm Risk|Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.|7-10 days after hemorrhage||||participants|||Number
1457674|NCT00795288|Primary|Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk|Resting cerebral blood flow during peak period of vasospasm risk measured by PET|7-10 days after hemorrhage|"Of the total population enrolled complete data sets were available on 25. This was due to patient refusal to perform the PET study, logistical difficulties and technical problems.~be completed in seven due to logistical difficulties (n = 4) or patient refusal (n = 3). Two of the completed studies could not be analyzed for technical reasons"|||mL/100 g/min||Standard Deviation|Mean
1457675|NCT00795210|Secondary|Insulin Sensitivity|"insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; M value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given"|after two weeks treatment|Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used.|||mg/kg/min||Standard Deviation|Mean
1457676|NCT00795210|Primary|Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug|Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.|after 2 weeks treatment|Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.|||ng/mL||Inter-Quartile Range|Median
1457677|NCT00795184|Primary|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett’s Esophagus.|Centralized histopathology confirmation within 4-6 weeks||||percentage of lesions|Participants|95% Confidence Interval|Number
1457678|NCT00795145|Secondary|Cohort 2: Number of Subjects With AEs and SAEs|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|SAS|||participants|||Number
1457681|NCT00795145|Secondary|Cohort 2: Tmax and t1/2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Tmax is the time to reach Cmax.|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||hr||Full Range|Median
1457682|NCT00795145|Secondary|Cohort 2: Cmax||Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
1457683|NCT00795145|Secondary|Cohort 2: AUC Inf and AUC Last|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|Predose, 30 minutes, 1, 2, 4, 8, 12 hours post-dose|PK parameter analysis population|||ug *hr/mL||Standard Deviation|Mean
1457684|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in Uncorrected QT Intervals Between Linezolid 600 mg and 1200 mg Compared to Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population|||msec|||Number
1457685|NCT00795145|Secondary|Cohort 2: Mean Time-Matched Difference in QTcF Intervals Between Moxifloxacin and Placebo|A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|PK parameter analysis population|||msec|||Number
1457686|NCT00795145|Primary|Cohort 2: Mean Time-Matched Difference in Time Corresponding to Beginning of Depolarization to Repolarization of the Ventricles, Corrected for Heart Rate Using Fridericia's Formula (QTcF Interval) Between Linezolid 600 mg and 1200 mg Compared to Placebo|The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia’s formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.|0.5, 1, 2, 4, 8, 12, 24 hours post-dose|The pharmacokinetic (PK) parameter analysis population was defined as all subjects randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||milliseconds (msec)|||Number
1457687|NCT00795145|Secondary|Cohort 1: Steady-State Volume of Distribution (Vss)|Vss = (mean residence time [The average total time molecules of a given dose spend in the body] extrapolated to infinity) multiplied by CL|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||L/kg||Standard Deviation|Mean
1457688|NCT00795145|Secondary|Cohort 1: Clearance of Linezolid (CL)|Drug clearance = Dose / AUC inf|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||mL/minute (min)/kilogram (kg)||Standard Deviation|Mean
1457689|NCT00795145|Secondary|Cohort 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||hr||Full Range|Median
1457690|NCT00795145|Secondary|Cohort 1: Maximum Observed Plasma Concentration (Cmax)||predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||ug/mL||Standard Deviation|Mean
1457691|NCT00795145|Secondary|Cohort 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) and Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC Last)|"AUC inf = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time.~AUC last = Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)."|predose, 30 minutes, and at 1 (end of infusion), 1.5, 2, 3, 4, 6, 8, 12, 24, and 46 hours after start of infusion|PK parameter analysis population|||microgram (ug)*hours (hr)/mL||Standard Deviation|Mean
1457692|NCT00795145|Primary|Cohort 1: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.|From the time the subject had taken at least one dose of study treatment up to 5 weeks|Safety Analysis Set (SAS): All subjects who received at least 1 dose of study medication.|||participants|||Number
1457693|NCT00795132|Secondary|Number of Participants Who Experienced Transplantation-related Mortality (TRM)|Cumulative incidence transplantation-related mortality (TRM)|24 months|All incidences of enrolled patients were analyzed.|||participants|||Number
1457694|NCT00795132|Secondary|Two Year Overall Survival|The probability that a given patient will be alive two years after transplantation.|24 months|All enrolled participants were analyzed.|||probability||Standard Error|Mean
1457695|NCT00795132|Primary|Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments|Assessed donor engraftment in very high risk pediatric patients.|24 months|All enrolled patients were analyzed except for the 3 patients who relapsed or died prior to engraftment.|||participants|||Number
1457696|NCT00795002|Secondary|Disease-free Survival|This will be defined as the time between study entry and the first date that recurrent or progressive disease is objectively documented, or death from any cause occurs.|up to 2 years|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy.|||months||95% Confidence Interval|Median
1457697|NCT00795002|Secondary|Number of Participants Experiencing Death From Any Cause Within 60 Days of Starting FLAM|Toxicity defined as death from any cause within 60 days of starting FLAM.|60 days|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy. Toxicity defined as death from any cause within 60 days of starting FLAM.|||Participants|||Count of Participants
1457698|NCT00795002|Primary|Complete Response|Bone marrow showing less than 5% leukemic blasts with normal maturation of all cell lines, an ANC of at least 1000/uL and a platelet count of 100,000/uL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. Repeat marrow confirmation 4-6 weeks following the marrow documenting CR is not required due to the need for continued treatment in CR.|1 year|39 patients had been enrolled in each arm with two patients in each arm receiving incomplete therapy|||participants|||Number
1457699|NCT00794963|Primary|Change in Weight||baseline and 8 months|4 participants in usual care arm did not return for follow-up and were not available for analysis; 1 participant in the integrated care group was lost to follow-up|||pounds||Standard Deviation|Mean
1457701|NCT00794924|Primary|Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group|Gastrointestinal motility was assessed by the number of days a patient was constipated or had diarrhea.|45 days of measuring the outcome|The number of participants was chosen in order to receive a difference by GEE statistical model with > 0.05 p value. The analysis was done per protocol.|||days of constipation or diarrhea||Standard Deviation|Mean
1457702|NCT00794820|Secondary|Overall Survival (OS) Rate|OS was defined as the time from the initiation of treatment to last follow-up date or death. OS were calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants is not included in analysis, the participant went off study after two months of treatment.|||Percentage of Participants|||Number
1457703|NCT00794820|Secondary|Remission Duration/Time to Progression (TTP)|TTP was defined as time from initiation of treatment to primary refractory disease or CLL progression. TTP was censored for therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) and death in remission. TTP calculated using Kaplan-Meier estimates.|6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.|||Months||Full Range|Median
1457704|NCT00794820|Primary|Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months|CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter’s transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD.|6 months|Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response. One of the 65 participants was not assessed for response to therapy therefore is not included in analysis. The participant went off study after two months of treatment and was not evaluable for response.|||Percentage of Participants|||Number
1457705|NCT00794677|Other Pre-specified|Percent Change of Non-high Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1457706|NCT00794677|Other Pre-specified|Percent Change in High Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1457707|NCT00794677|Other Pre-specified|Percent Change of Low Density Lipoprotein Cholesterol||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1457708|NCT00794677|Other Pre-specified|Percent Change of Apolipoprotein B||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||percent||Standard Error|Mean
1457709|NCT00794677|Other Pre-specified|Log (AUC of Plasma Triglyceride) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, one subject eliminated because the AUC was negative and cannot be log transformed|||Log(mg/dl)||Standard Error|Mean
1457710|NCT00794677|Other Pre-specified|Log (AUC of Plasma Total Cholesterol) After an Oral Bolus||Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol, restricted to changes that were nonnegative because there is no log for a negative number|||Log(mg/dl)||Standard Error|Mean
1457711|NCT00794677|Other Pre-specified|Log(Fasting Plasma Levels of Diet-derived Oxysterols (7-ketocholesterol))||Fasting measurements after 6 weeks on ezetimibe vs placebo|Per protocol|||Log(mg/dl)||Standard Error|Mean
1457712|NCT00794677|Secondary|Log(Maximal Plasma Concentration (Cmax) of 7-ketocholesterol) After an Oral Bolus|Log Cmax of 7 ketocholesterol after an oral bolus in patients with primary hypercholesterolemia.|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|Per protocol|||Log(mg/dl)||Standard Error|Mean
1457713|NCT00794677|Primary|Log[Area-under-the-plasma-concentration-curve(AUC) 0-8 Hours 7-ketocholesterol] After an Oral Bolus|Log of Area-under-the-plasma-concentration curve (AUC 0-8hrs) of 7-ketocholesterol after an oral bolus in patients with primary hypercholesterolemia after treatment with ezetimibe versus placebo|Over 8 hours after 6 weeks of treatment with ezetimibe or placebo|per protocol|||Log(mg/dl)||Standard Error|Mean
1457714|NCT00794664|Other Pre-specified|HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457715|NCT00794664|Other Pre-specified|Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457716|NCT00794664|Other Pre-specified|Apo-A1 at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457717|NCT00794664|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) at Primary Efficacy Time Point (PET)|Apo-A1 was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457718|NCT00794664|Other Pre-specified|Ratio of LDL-C to HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||ratio||Inter-Quartile Range|Median
1457719|NCT00794664|Other Pre-specified|Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol (LDL-C) to High-density Lipoprotein Cholesterol (HDL-C) at Primary Efficacy Time Point (PET)|LDL-C and HDL-C were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1457720|NCT00794664|Other Pre-specified|VLDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457721|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Primary Efficacy Time Point (PET)|VLDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457722|NCT00794664|Other Pre-specified|Lipoprotein(a) at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457723|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Lipoprotein(a) at Primary Efficacy Time Point (PET)|Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457724|NCT00794664|Other Pre-specified|Triglycerides at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457725|NCT00794664|Other Pre-specified|Percentage Change From Baseline in Triglycerides at Primary Efficacy Time Point (PET)|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457726|NCT00794664|Secondary|Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457727|NCT00794664|Secondary|Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET)|Non-HDL-C was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457728|NCT00794664|Secondary|Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457858|NCT00793793|Secondary|Rapid Virologic Response (RVR)|Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.|week 4|FAS (as randomized)|||percentage of responders||95% Confidence Interval|Number
1457729|NCT00794664|Secondary|Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET)|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457730|NCT00794664|Secondary|Apo-B at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457731|NCT00794664|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point|Apo-B was measured in mg/dL. Samples were taken following an overnight fast. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1457732|NCT00794664|Primary|LDL-C at Baseline and the Primary Efficacy Time Point (PET)|The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set|||mg/dL||Standard Deviation|Mean
1457733|NCT00794664|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides >=400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood draw or was drawn more than 4 weeks prior to Study Day 1. The PET was the post-baseline visit, for which LDL-C was assessed, closest to 14 days after the last dose of study drug.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET) up to week 28|Full analysis set (FAS). The FAS, which represents the practically-feasible intent-to-treat (ITT) population as delineated in ICH Guideline E9, consists of treated participants with a valid baseline and at least one post-baseline LDL-C measure.|||percentage of baseline||Standard Deviation|Mean
1457734|NCT00794560|Secondary|Patient Satisfaction||at the end of the individual drug therapy, an average of 18 days|||||||
1457735|NCT00794560|Secondary|Compliance|objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).|at the end of the individual drug therapy, an average of 18 days||||percentage of syringes||Standard Deviation|Mean
1457736|NCT00794560|Primary|Drug Use Problems|During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.|during the individual drug therapy, an average of 18 days||||scores on a scale||Standard Deviation|Mean
1457737|NCT00794547|Other Pre-specified|To Correlate the Pharmacokinetic Parameters of Systemic Calcitriol Exposure (AUC) With SNPs of the 24-hydroxylase (CYP24), the Major Vitamin D3 Inactivating Enzyme.||3-6 months|||||||
1457738|NCT00794547|Secondary|Mean AUC 1,25-D3 Concentration at 12 and 24 Hours|The mean AUC (area under the curve) concentrations of 1,25-D3 from 0-12 hours and 0-24 hours will be calculated.|12 and 24 hours post dose|Patients from the phase II portion of the study were included in the pharmacokinetics analysis|||h*ng/mL||Standard Error|Mean
1457739|NCT00794547|Primary|Median Overall Survival|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, overall survival was determined.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.|||months||95% Confidence Interval|Median
1457740|NCT00794547|Primary|Median Time to Progression|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. To assess the response, median time to progression was determined. Progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|5 years|22 patients were treated at the Maximum Tolerated Dose, including 6 phase I patients who received the MTD during the phase 1 component. 1 of 6 phase 1 patients was not evaluable due to toxicity. 1 patient (of 16) in the phase 2 study went to another therapy prior to the 30 day window and was excluded from analysis. 20 patients were analyzed.|||months||95% Confidence Interval|Median
1457741|NCT00794547|Primary|Number of Participants That Experience Grade 3 or Greater Neutropenia|The second primary objective was to characterize the toxicity and response of patients treated with a combination of calcitriol, cisplatin and docetaxel. Toxicity was assessed, in part, by noting the number of participants that experience grade 3 or greater neutropenia in each phase of the trial. Toxicities were recorded using NCI CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 and were followed for 30 days after the date of withdrawal from study drug.|30 days after last dose|Thirty-four patients were enrolled (18 in phase I and 16 in phase II). 16 of 18 patients enrolled in the Phase 1 portion of the study were evaluable for toxicity. One patient in the phase II study went to another therapy prior to the 30 day window for a confirmatory scan and was thus excluded from analysis.|||participants|||Number
1457742|NCT00794547|Primary|MTD of Intravenous Calcitriol When Administered Prior to Fixed Dose Cisplatin 75mg/m2 and Docetaxel 75 mg/m2, Every 3 Weeks in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)|The primary objective was to determine the Maximum Tolerated Dose (MTD) of intravenous calcitriol when administered prior to fixed dose cisplatin 75mg/m2 and docetaxel 75 mg/m2, every 3 weeks in patients with advanced non-small cell lung cancer (NSCLC). Accrual duration for the study is 5 years.|5 years|Eighteen patients were enrolled, and 16 were evaluable for toxicity assessments. Two patients were not evaluable as they progressed prior to completion of cycle 1.|||mcg/m^2|||Number
1457743|NCT00794508|Secondary|Number of Participants Reaching the Normal Range of ADA Enzyme Activity|As measured by ADA enzyme activity in peripheral blood mononuclear cells|2 years||||participants|||Number
1457744|NCT00794508|Secondary|Number of Participants With Greater Than 1% of Gene-Modified Cells in the Peripheral Blood|As measured by quantitative polymerase chain reaction in peripheral blood cells separated into mononuclear and granulocyte fractions.|2 years||||participants|||Number
1457745|NCT00794508|Primary|Number of Participants With Adverse Events|"Examine the safety of the procedure: harvesting bone marrow, isolating CD34+ hematopoietic stem/progenitor cells, performing ex vivo gene transduction with the MND-ADA gamma-retroviral vector, giving 90 mg/m2 busulfan to make space in the bone marrow to aid engraftment, and re-infusing the autologous gene-modified cells."|2 years||||participants|||Number
1457746|NCT00794469|Primary|Baseline Metabolic Rate|baseline metabolic rate|baseline||||kcal/d||Standard Deviation|Mean
1457747|NCT00794469|Primary|Post-drinking Metabolic Rate|resting metabolic rate after drinking water|1 hour||||kcal/d||Standard Deviation|Mean
1457748|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 12|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 12|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
1457749|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 8|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 8|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
1457750|NCT00794365|Primary|Percentage of Participants With 7-day Point Prevalence of Smoking Cessation at Week 4|Participants who abstained from smoking in last 7 days. Abstained = response of no to both Nicotine Use Inventory questions: “In last 7 days has subject 1) smoked any cigarettes (even a puff)?, and 2) used any other nicotine-containing products?”. Participants who discontinued study were counted as a smoker for the 7-day point prevalence from the timepoint of discontinuation through end of study.|Week 4|Intent-to-Treat (ITT): participants who took at least 1 dose of varenicline tablets.|||percentage of participants||95% Confidence Interval|Number
1457751|NCT00794313|Secondary|Modified Abnormal Involuntary Movement Scale Area Under the Curve|Area under the curve computed for whole body (total) mAIMS (Modified Abnormal Involuntary Movement Scale) scores at each time measurement. This is a commonly utilized scale that is completed by an observer who judges the severity of levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms). All body parts are rated separately on this 0 (none) to 4 (severe – markedly impairs activities) scale. Thus, the total score can range from 0 – 28 with 28 indicating the most severe LID. mAIMS ratings occur as the subject performs the cognitive task while standing on the force plate. mAIMS ratings are made every half hour during the levodopa (LD) dose cycle.|Measured every 1/2 hour for a levodopa dose cycle (starting 1 hour prior to infusion and ending 4 hours post 2-hour infusion)||||Units on a Scale * Hours||Standard Deviation|Mean
1457752|NCT00794313|Primary|Forceplate AUC|Area under the curve for the root mean squared velocity in the anterior-posterior direction as measured by a forceplate.|Every 1/2 hour for 8 hour levodopa cycle|triple cross-over study design.|||(meters/second)*hours||Standard Deviation|Mean
1457753|NCT00794196|Secondary|Patient Wellbeing|"Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life.~The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health."|0, 3 and 6 months||||units on a scale||95% Confidence Interval|Mean
1457754|NCT00794196|Primary|Adherence to Antidepressant Medication|Adherence to antidepressant medication was measured through Pharmacy records|At 3 and 6 months||||percentage of adherence patients||95% Confidence Interval|Number
1457755|NCT00794170|Primary|Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)|The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review. Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview. Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview. Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview). Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame. Self-report of nonadherence in any of these three areas classified the subject as nonadherent.|Baseline and 12 months|The two treatment groups were compared on change in the percent of adherent patients between baseline and follow-up using a longitudinal logistic regression model fit using a generalized linear model. A p-value less than 0.05 was considered statistically significant. No statistical comparison was done.|||participants|||Number
1457756|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|Prior to last dose at Week 12 (Day 84)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1457757|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 8 (Day 57)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1457758|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 4 (Day 29)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1457759|NCT00794157|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|After Week 2 (Day 15)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.|||Liters||Standard Error|Least Squares Mean
1457760|NCT00794157|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.|End of treatment (Week 12 + 1 day, Day 85)|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).|||Liters||Standard Error|Least Squares Mean
1457761|NCT00794144|Primary|Number of Participants With Anatomic Nasal Exam Abnormalities|The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa|Day 1 (Baseline) to Exit||||Participants|||Number
1457762|NCT00794118|Secondary|Indirect Costs|Indirect costs represent the loss of resources as a consequence of work disability or unemployment.|Baseline, Months 3, 6, 9 and 12||2012-08-31|08/2012||||
1457763|NCT00794118|Secondary|Direct Costs|Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.|Baseline, Months 3, 6, 9 and 12||2012-08-31|08/2012||||
1457764|NCT00794118|Primary|36-Item Short-Form Health Survey (SF-36) at Month 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
1457765|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 12|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
1457766|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 9|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1457767|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 6|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1457768|NCT00794118|Primary|Stanford Health Assessment Questionnaire (HAQ) Score at Month 3|HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1457769|NCT00794118|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||minutes||Standard Deviation|Mean
1457770|NCT00794118|Primary|Duration of Morning Stiffness at Month 9|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
1457771|NCT00794118|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
1457772|NCT00794118|Primary|Duration of Morning Stiffness at Month 3|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||minutes||Standard Deviation|Mean
1457773|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1457774|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457775|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457776|NCT00794118|Primary|Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3|Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457777|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 12|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1457778|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 9|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457779|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 6|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457780|NCT00794118|Primary|Number of Participants With Anti-nuclear Antibodies at Month 3|Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457781|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1457782|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457783|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457784|NCT00794118|Primary|Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3|Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual’s own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457785|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Participants|||Number
1457786|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 9|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457787|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457788|NCT00794118|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 3|RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Participants|||Number
1457789|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||mm/hr||Standard Deviation|Mean
1457790|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 9|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
1457791|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
1457792|NCT00794118|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 3|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||mm/hr||Standard Deviation|Mean
1457793|NCT00794118|Primary|C-reactive Protein (CRP) at Month 12|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||mg/dL||Standard Deviation|Mean
1457794|NCT00794118|Primary|C-reactive Protein (CRP) at Month 9|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
1457795|NCT00794118|Primary|C-reactive Protein (CRP) at Month 6|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
1457796|NCT00794118|Primary|C-reactive Protein (CRP) at Month 3|CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||mg/dL||Standard Deviation|Mean
1457797|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 12|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
1457798|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 9|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457799|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 6|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457800|NCT00794118|Primary|Visual Analogue Scale for Pain (VAS-pain) at Month 3|10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457801|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
1457802|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 9|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457803|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457804|NCT00794118|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 3|PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457805|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 12|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||cm||Standard Deviation|Mean
1457806|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 9|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457807|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 6|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457808|NCT00794118|Primary|Patient Global Assessment (PtGA) of Disease Activity Score at Month 3|PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||cm||Standard Deviation|Mean
1457809|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.|||Units on a Scale||Standard Deviation|Mean
1457810|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1457811|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1457812|NCT00794118|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Month 3|ITT population included all participants who received at least 1 dose of the study medication.|||Units on a Scale||Standard Deviation|Mean
1457813|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.|Month 12|ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).|||Percentage of participants|||Number
1457814|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 9|ITT population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1457815|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.|Month 6|ITT population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1457816|NCT00794118|Primary|Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3|DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.|Month 3|Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.|||Percentage of participants|||Number
1457817|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1457818|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|3 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1457819|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|day 1 postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1457820|NCT00793910|Secondary|Occurence of Use of Rescue Medication|Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured|2 hours to 4 days postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||# of times rescue meds were used||Standard Deviation|Mean
1457821|NCT00793910|Primary|Level of Pain|level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)|2 hours postoperatively|11 patients who had alcohol-assisted PRK were removed from data analysis; 1 patient was disenrolled due to nausea secondary to oxycodone-acetaminophen (Percocet) intake|||units on a scale||Standard Deviation|Mean
1457822|NCT00793871|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Status|ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead).|Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug)|Safety analysis set included all participants who started study treatment.|||participants|||Number
1457823|NCT00793871|Secondary|Number of Participants With Significant Vital Signs Changes From Baseline|Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) > 100 mm Hg, or SBP > 200 mm Hg and/or DBP > 110 mm Hg; temperature: >38.3 degrees Celsius (degrees C), or increase of greater than or equal to (>=)1.1 degrees C (baseline >=36.8 degrees C); heart rate: >120 beats per minute (bpm) or less than (<) 50 bpm, or increase of >=30 bpm or decrease of ≥30 bpm; respiration rate: > 40 /minute or < 8 /minute; weight: a change of 5% or more from baseline.|Baseline (Day 1) up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
1457824|NCT00793871|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination.|Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
1457825|NCT00793871|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests.|Baseline up to 28 days post last administration of study drug|Safety analysis set included all participants who started study treatment.|||participants|||Number
1457826|NCT00793871|Other Pre-specified|Time to Tumor Response (TTR)|TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed.|Baseline (Day 1) to tumor response (up to 82 weeks)|All participants who started study treatment (safety analysis set) had a confirmed objective tumor response.|||weeks||95% Confidence Interval|Median
1457839|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)|PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available MRTpo,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
1457859|NCT00793793|Secondary|Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients|Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised) including patients with available viral load data.|||Log10 IU/mL||Inter-Quartile Range|Median
1457827|NCT00793871|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0.|Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)|Safety analysis set included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
1457828|NCT00793871|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline (Day 1) up to end of study treatment (up to 276 weeks)|The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment.|||% of participants||95% Confidence Interval|Number
1457829|NCT00793871|Secondary|Overall Survival (OS)|"OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause.~In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive."|Baseline (Day 1) to death (up to 282 weeks)|Safety analysis set included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
1457830|NCT00793871|Primary|Progression-free Survival (PFS)|PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven’t yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a >=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)|Safety analysis included all participants who started study treatment.|||weeks||95% Confidence Interval|Median
1457831|NCT00793819|Primary|Change in Nocturia Episodes||12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||episodes||Standard Deviation|Mean
1457832|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAauc data|||ratio||Geometric Coefficient of Variation|Geometric Mean
1457833|NCT00793793|Secondary|Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax|For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.|Day 1, Day 14, and Day 28|TS including patients with available RAcmax data|||ratio||Geometric Coefficient of Variation|Geometric Mean
1457834|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1457835|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1457836|NCT00793793|Secondary|PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )|PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)|TS (for TN patients only)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1457837|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )|PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration [L] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Vz/F,ss data|||L||Geometric Coefficient of Variation|Geometric Mean
1457838|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )|PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration [mL/min] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available CL/F,ss data|||mL/min||Geometric Coefficient of Variation|Geometric Mean
1457840|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state [h] )|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available t1/2,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
1457841|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available AUCτ,ss data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1457842|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)|PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmin,ss data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1457843|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )|PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available tmax,ss data|||h||Geometric Coefficient of Variation|Geometric Mean
1457844|NCT00793793|Secondary|PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).|Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)|TS including patients with available Cmax,ss data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1457845|NCT00793793|Secondary|PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)|PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1457846|NCT00793793|Secondary|PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)|PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||h||Geometric Coefficient of Variation|Geometric Mean
1457847|NCT00793793|Secondary|PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)|PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).|Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)|TS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1457848|NCT00793793|Secondary|Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period|Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.|from day 1 and up to 4 weeks|TS|||percentage of participants discontinued|||Number
1457849|NCT00793793|Secondary|Occurrence of AEs, by Action Taken With Regard to Study Medication|Occurrence of AEs, by action taken with regard to study medication.|from day 1 and up to 4 weeks|TS|||percentage of participants|||Number
1457850|NCT00793793|Secondary|Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time|Achievement of a >= 2 log10 reduction in plasma HCV RNA level from baseline over time.|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
1457851|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Quantification Over Time|Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
1457852|NCT00793793|Secondary|Achievement of an HCV RNA Level Below the Limit of Detection Over Time|Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time|from day 1 and up to 4 weeks|FAS|||percentage of participants|||Number
1457853|NCT00793793|Secondary|Sustained Virologic Response (SVR)|Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).|week 72|FAS|||percentage of responders|||Number
1457854|NCT00793793|Secondary|End of Treatment Response (ETR)|End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).|week 48|FAS|||percentage of responders|||Number
1457855|NCT00793793|Secondary|Complete EVR2 (cEVR2)|VL below the limit of detection at both 4 weeks and 12 weeks|week 4 and week 12|FAS|||percentage of responders|||Number
1457856|NCT00793793|Secondary|Complete EVR1 (cEVR1)|VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks|week 4 and week 12|FAS|||percentage of responders|||Number
1457857|NCT00793793|Secondary|Early Virologic Response (EVR)|Early Virologic Response (EVR): >=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)|week 12|FAS|||percentage of responders|||Number
1457860|NCT00793793|Secondary|Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients|Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.|Baseline and up to 4 weeks|FAS (as randomised)|||log10 IU/mL||Inter-Quartile Range|Median
1457861|NCT00793793|Primary|Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time|"Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.~ALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT)."|Baseline and up to 4 weeks|TS|||participants with grade 3 or 4 abnormal|||Number
1457862|NCT00793793|Primary|Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period|Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|TS|||percentage of participants with SAEs|||Number
1457863|NCT00793793|Primary|Occurrence of Adverse Events (AEs) During BI201335 + Washout Period|Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.|from day 1 and up to 4 weeks + 4 days washout|Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.|||percentage of participants with AEs|||Number
1457864|NCT00793793|Primary|Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)|Efficacy endpoint: VR (virologic response) of >=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).|Baseline and up to 4 weeks|Full Analysis Set (FAS): All randomized TN patients and treatment experienced patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.|||percentage of responders||95% Confidence Interval|Number
1457865|NCT00793780|Secondary|Change in Questionnaire on Craving for Sweet or Rich Foods Score|The Questionnaire on Craving for Sweet or Rich Foods (QCSRF) is a 2-factor, 9-item scale assessing the presence of cravings for rich and sweet foods and has been found to have good psychometric properties. The total score is the total of 2 sub scales. Total range is from 9 to 63, with a higher score indicative of a higher craving and reinforcement from sweet and/or rich foods.|baseline and week 8||||units on a scale||Standard Deviation|Mean
1457866|NCT00793780|Secondary|LDL Cholesterol|Determined by standard enzymatic procedures|baseline and week 8||||mg/dL||Standard Deviation|Mean
1457867|NCT00793780|Secondary|Insulin Levels|Determined with a double-antibody radioimmunoassay|baseline and week 8||||microIU/mL||Standard Deviation|Mean
1457868|NCT00793780|Secondary|PANSS- Positive and Negative Symptom Scale|The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Total score ranges from a minimum of 30 to a maximum of 210. A higher score indicates more severe symptoms.|8 weeks||||units on a scale||Standard Deviation|Mean
1457869|NCT00793780|Secondary|Fasting Serum Glucose Lab Values||baseline and 8 weeks||||mg/dL||Standard Deviation|Mean
1457870|NCT00793780|Primary|Change in Body Weight From Baseline|Weight was measured with shoes off to the nearest 0.1 kg.|8 weeks||||kg||95% Confidence Interval|Mean
1457871|NCT00793650|Secondary|Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.|"CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour.~Partial Response:>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200mg per 24 hour."|100 days after transplant|As per the protocol.|||participants|||Number
1457872|NCT00793650|Primary|Safety and Engraftment|Peripheral blood progenitor cells were collected with either chemo-mobilization (27 of 39, 69%) or growth factor mobilization (12 of 39, 31%). Patients received an average of 9.0 × 10^6/kg CD34+ cells (range, 2.3-65) as their transplant graft.|Day 30 after transplant|As per the protocol|||days||Full Range|Median
1457873|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis|This outcome measure describes the combined analysis of the trials NCT00793624 and NCT00796653. Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
1457874|NCT00793624|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of cardiac disorders and investigations related to treatment.|48 weeks|Treated set.|||percentage of participants|||Number
1457875|NCT00793624|Secondary|Absolute Plasma Concentrations|Absolute plasma concentrations of Olodaterol. Values presented are across visits and summarised into geometric means.|within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18|Pharmacokinetic set includes all patients in the treated set who had at least one valid olodaterol plasma concentration measurement after initial administration of study drug. This set is restricted to patients in either the Olodaterol 5 μg or 10 μg dose group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1457876|NCT00793624|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1457877|NCT00793624|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1457878|NCT00793624|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD ex. per patient year||Standard Error|Mean
1457879|NCT00793624|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
1457880|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
1457881|NCT00793624|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||Days||95% Confidence Interval|Mean
1457882|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 48 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457883|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 40 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 40|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457884|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 32 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 32|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457885|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 18 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 18|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457886|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 12 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457945|NCT00793572|Primary|Progression-free Survival|"Confidence intervals will be estimated.~Progressive disease:~Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant.~Appearance of new lytic bone lesions or plasmacytomas."|At 2 years after the autograft||||Participants|||Count of Participants
1457887|NCT00793624|Secondary|Mahler Transitional Dyspnea Index Focal Score at 6 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457888|NCT00793624|Secondary|Patient's Global Rating (PGR) at 48 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457889|NCT00793624|Secondary|Patient's Global Rating (PGR) at 24 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457890|NCT00793624|Secondary|Patient's Global Rating (PGR) at 12 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457891|NCT00793624|Secondary|Patient's Global Rating (PGR) at 6 Weeks|Patient's Global Rating (PGR) was a patient assessment of their health (respiratory condition) at each visit (compared to the day before they started study drug) and ranged from 1 (very much better) to 7 (very much worse).|Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457892|NCT00793624|Secondary|Use of Rescue Medication at Week 24|Mean number of puffs of rescue medication used per day (daytime/nighttime/total)|Week 24|FAS|||Number of puffs||Standard Error|Mean
1457893|NCT00793624|Secondary|Peak Expiratory Flow Rate (PEFR) at Week 24|Weekly mean pre-dose morning and evening PEFR. Results are from non−MMRM ANCOVA models by week, with Last observation carried forward (LOCF) up to each week. Fixed effects include treatment, tiotropium, strata and baseline.|Week 24|FAS|||L/min||Standard Error|Mean
1457894|NCT00793624|Secondary|Peak FVC (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457895|NCT00793624|Secondary|Peak FVC (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457896|NCT00793624|Secondary|Peak FVC (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457905|NCT00793624|Secondary|Trough FVC Response at Week 6|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1457897|NCT00793624|Secondary|Peak FVC (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457898|NCT00793624|Secondary|Peak FVC (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FVC was defined as the mean of the available pre-dose peak FVC values prior to first dose of randomized treatment. Peak FVC (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457899|NCT00793624|Secondary|Trough FVC Response at Week 40|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1457900|NCT00793624|Secondary|Trough FVC Response at Week 48|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1457901|NCT00793624|Secondary|Trough FVC Response at Week 32|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1457902|NCT00793624|Secondary|Trough FVC Response at Week 24|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1457903|NCT00793624|Secondary|Trough FVC Response at Week 18|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1457904|NCT00793624|Secondary|Trough FVC Response at Week 12|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1457941|NCT00793572|Secondary|Non-relapse Mortality|Confidence intervals will be estimated. Assessed at 200 days and 1 year after allograft.|200 and 365 days after allo||||Participants|||Count of Participants
1457942|NCT00793572|Secondary|Incidence of Toxicities Related to Bortezomib Maintenance Therapy After the Stem Cell Transplantation|Confidence intervals will be estimated.|Up to 100 days after the autograft or allograft||||Participants|||Count of Participants
1457906|NCT00793624|Secondary|Trough FVC Response at Week 2|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVC performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1457907|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457908|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457909|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457910|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457911|NCT00793624|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457912|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457913|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457914|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457915|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457916|NCT00793624|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457917|NCT00793624|Secondary|Trough FEV1 Response at Week 48|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.|FAS|||Liter||Standard Error|Least Squares Mean
1457918|NCT00793624|Secondary|Trough FEV1 Response at Week 40|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.|FAS|||Liter||Standard Error|Least Squares Mean
1457919|NCT00793624|Secondary|Trough FEV1 Response at Week 32|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.|FAS|||Liter||Standard Error|Least Squares Mean
1457920|NCT00793624|Secondary|Trough FEV1 Response at Week 18|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.|FAS|||Liter||Standard Error|Least Squares Mean
1457943|NCT00793572|Secondary|Incidence of Chronic GVHD|Confidence intervals will be estimated.|1 year post allo||||Participants|||Count of Participants
1457921|NCT00793624|Secondary|Trough FEV1 Response at Week 12|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.|FAS|||Liter||Standard Error|Least Squares Mean
1457922|NCT00793624|Secondary|Trough FEV1 Response at Week 6|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.|FAS|||Liter||Standard Error|Least Squares Mean
1457923|NCT00793624|Secondary|Trough FEV1 Response at Week 2|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.|FAS|||Liter||Standard Error|Least Squares Mean
1457924|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457925|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457926|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457927|NCT00793624|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457944|NCT00793572|Secondary|Incidence of Grades II-IV Acute GVHD|Confidence intervals will be estimated.|100 days post allo||||Participants|||Count of Participants
1457928|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations). This is a combined analysis of the data from NCT00793624 and NCT00796653 showing adjusted values using a MMRM model.|Baseline, Week 24|Full analysis sets (FAS) of the trials NCT00793624 and NCT00796653. FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Mean
1457929|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 48|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457930|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 12|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457931|NCT00793624|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks|Saint George's Respiratory Questionnaire (SGRQ) measures the impact of COPD on overall health, daily life, and perceived well-being ranging from 0 (no limitations) to 100 (most limitations).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457932|NCT00793624|Primary|Mahler Transitional Dyspnea Index Focal Score at 24 Weeks|Mahler Transitional Dyspnea Index (TDI) focal score measures 3 components of dyspnea that evoke dyspnea in daily living: Functional Impairment, Magnitude of Task, and Magnitude of Effort. The TDI measures the change from the baseline assessment ranging from -9 (most deterioration) to +9 (most improvement).|Baseline, Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||score on a scale||Standard Error|Least Squares Mean
1457933|NCT00793624|Primary|Trough FEV1 Response at Week 24|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.|FAS|||Liter||Standard Error|Least Squares Mean
1457934|NCT00793624|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before 24 weeks for any of the co-primary efficacy variables.|||Liter||Standard Error|Least Squares Mean
1457935|NCT00793611|Secondary|Patient Global Impression of Improvement|Outcome measure is only administered at follow-up and used following treatment in patients with urinary incontinence. Measure varies from 1 to 7 on a Likert scale. 1=very much better and 7=very much worse and 4=no change. Thus, lower numbers represent greater improvement.|6-12 weeks after study initiation (@ completion of intervention)|ITT|||units on a scale||Standard Deviation|Mean
1457936|NCT00793611|Secondary|Change in Voiding Frequency Based on Voiding Diary|change in mean number of voids per 24 hours. Each participant recorded voiding frequency every 24 hours for 3 days at baseline and follow-up. A mean number of voids for every patient over 24 hours was calculated at baseline and follow-up.|baseline and 6-12 weeks after study initiation|ITT change in mean number of voids/24 hours|||number of voids per 24 hours||Standard Deviation|Mean
1457937|NCT00793611|Primary|Change in Overactive Bladder Symptoms (Based on OABqSF)|Scale information; Score ranges for oab-qsf quality of life scores range from 13-78; 13=poor quality of life 78=good quality of life. We reported change scores, with larger negative numbers indicating greater improvement in quality of life scores.|baseline and approximately 6-12 weeks after study initiation|ITT|||units on a scale||Standard Deviation|Mean
1457938|NCT00793585|Secondary|The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).||baseline and 6 months|We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.|||Upro/cr (mg/g)||Standard Deviation|Mean
1457939|NCT00793585|Primary|Change in Renal Function as Measured With eGFR||baseline and 6 months||||eGFR(min/ml)||Standard Deviation|Mean
1457940|NCT00793572|Secondary|OS|Estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.|At 2 years after the autograft||||Participants|||Count of Participants
1457946|NCT00793546|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457947|NCT00793546|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457948|NCT00793546|Secondary|Maximum Observed Plasma Concentration (Cmax)||0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457949|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) = worst imaginable health state to 100 mm =best imaginable health state; higher scores indicate a better health state.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457950|NCT00793546|Secondary|Euro Quality of Life (EQ-5D)- Health State Profile Utility Score|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457951|NCT00793546|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)|FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Part 2 Baseline, Week 12, 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457952|NCT00793546|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457953|NCT00793546|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Part 2 Baseline until death or up to 24 months|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457954|NCT00793546|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457955|NCT00793546|Secondary|Progression Free Survival (PFS) Based on Investigator|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457956|NCT00793546|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 28 days after the last dose|Safety population included all participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1457980|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 12|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457957|NCT00793546|Primary|Progression Free Survival (PFS) Based on Independent Radiologist|"Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose|Data were not analyzed because the study was prematurely terminated due to unfavorable risk benefit ratio of the study treatment.||||||
1457958|NCT00793520|Primary|Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.|Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.|Week 0, 5, 7 and 12||||Kg||95% Confidence Interval|Mean
1457959|NCT00793520|Secondary|Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.|DNIC is evaluated using a conditioning stimulus and a test stimulus. Painful blunt pressure is applied to the thumbnail of the patient's left hand for 30 sec. Patient rates pain experienced on numerical scale of 0(no pain) to 100(worst pain) at 10, 20 & 30 sec. This is repeated 3 times and a mean pain score is calculated. 5 minutes following test stimulus, patient’s right hand is immersed in 12C water at 30 sec test stimulus is reapplied and a 2nd mean pain score is calculated. The difference in mean pain rating before and after conditioning stimulus indicates presence and magnitude of DNIC|Weeks 0, 5, 7 and 12||||Pain Rating||95% Confidence Interval|Mean
1457960|NCT00793455|Secondary|Colorectal Cancer Screening Completion|"We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|6 months post randomization|Analysis was based on intention to treat.|||participants|||Number
1457961|NCT00793455|Primary|Colorectal Cancer Screening Completion.|"We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.~Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening."|3 months post randomization|Analysis was based on intention to treat.|||participants|||Number
1457962|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12|SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457963|NCT00793403|Primary|Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6|SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457964|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 12|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457965|NCT00793403|Primary|Recent-Onset Arthritis Disability (ROAD) at Month 6|ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457981|NCT00793403|Primary|Visual Analog Fatigue Scale (VAFS) at Month 6|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457966|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 12|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457967|NCT00793403|Primary|Health Assessment Questionnaire (HAQ) at Month 6|HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457968|NCT00793403|Primary|Duration of Morning Stiffness at Month 12|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457969|NCT00793403|Primary|Duration of Morning Stiffness at Month 6|Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457970|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 12|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1457971|NCT00793403|Primary|Patient Assessment of Arthritis Pain at Month 6|Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1457972|NCT00793403|Primary|Patient’s General Health Assessment at Month 12|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457973|NCT00793403|Primary|Patient’s General Health Assessment at Month 6|"Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor."|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457974|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 12|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457975|NCT00793403|Primary|Number of Participants With Rheumatoid Factor (RF) at Month 6|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457976|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 12|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hour||Standard Deviation|Mean
1457977|NCT00793403|Primary|Erythrocyte Sedimentation Rate (ESR) at Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mm/hr||Standard Deviation|Mean
1457978|NCT00793403|Primary|C-reactive Protein (CRP) at Month 12|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/dL||Standard Deviation|Mean
1457979|NCT00793403|Primary|C-reactive Protein (CRP) at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is <1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||mg/dL||Standard Deviation|Mean
1457982|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 12|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1457983|NCT00793403|Primary|Physician Global Assessment (PGA) of Disease Activity at Month 6|Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1457984|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 12|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1457985|NCT00793403|Primary|Patient Global Assessment (PtGA) of Disease Activity at Month 6|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||cm||Standard Deviation|Mean
1457986|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 12|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457987|NCT00793403|Primary|Clinical Arthritis Activity (CLARA) Index at Month 6|CLARA: index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC (based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457988|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457989|NCT00793403|Primary|Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6|PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant’s physical function (12 questions each scored on a 0 [without any difficulty] to 4 [unable to do] point scale); TJC(based on 16-joints, tenderness assessed on 0 [none] to 3 [severe] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant’s physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457990|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 12|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457991|NCT00793403|Primary|Clinical Disease Activity Index (CDAI) at Month 6|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457992|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457993|NCT00793403|Primary|Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6|RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1457994|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 12|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457995|NCT00793403|Primary|Simplified Disease Activity Index (SDAI) at Month 6|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457996|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 12|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457997|NCT00793403|Primary|Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28 < 2.6 = remission.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1457998|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 12|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Joints||Standard Deviation|Mean
1457999|NCT00793403|Primary|Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6|"Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.~Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1."|Month 6|"Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||Joints||Standard Deviation|Mean
1458000|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1458001|NCT00793403|Primary|Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6|GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC <=2 (based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR <=20 mm/hr.|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1458002|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); HAQ <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR <=20 mm/hr.|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1458015|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.|To determine whether age is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1458003|NCT00793403|Primary|Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6|OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain <=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC <=1; TJC <=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) <=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA <=1.5; PtGA <=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) <=20 millimeter per hour (mm/hr).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1458004|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12|Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC <=1; SJC <=1 (TJC, SJC based on 28-joints); CRP <=1 mg/dL; PtGA<=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had SDAI score of <=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA [assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 12|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1458005|NCT00793403|Primary|Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6|Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(<=)1;swollen joint count(SJC)<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) <=1 (assessed on 0-10 centimeter[cm] visual analog scale[VAS]) or 2) participant had Simplified Disease Activity Index score of <=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment [PGA, assessed on 0-10 cm VAS], and CRP [mg/dL]).|Month 6|Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.||||||
1458006|NCT00793325|Primary|Change in Height SD Score for Calendar Age.|The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.|||standard deviation (SD) score||Standard Deviation|Mean
1458007|NCT00793325|Primary|Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.|Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.|Up to 3 years|The efficacy analysis population basically consists of the evaluable participants in whom the changes in the growth rate SD score for calendar age and in the height SD score for calendar age were assessed.|||standard deviation (SD) score||Standard Deviation|Mean
1458008|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).|To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
1458009|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.|To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
1458010|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.|To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||Participants|||Number
1458011|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications|To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1458012|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.|To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1458013|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.|To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1458014|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.|To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1458016|NCT00793325|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||events|||Number
1458017|NCT00793325|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.|Up to 3 years|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1458018|NCT00793182|Primary|Evaluate the Incidence of Contrast-induced Nephropathy (CIN), Defined as an Increase of ≥ 25% or an Increase of ≥ 0.5 mg/dL From Baseline Serum Creatinine (SCr), Within 48 - 72 Hours After Contrast Administration.||Labs obtained 2-24 hours before and 48-72 hours after contrast administration, with a 7-day follow-up if indicated|There were no subjects with a postcontrast Scr measurement reflecting an increase of ≥25% or ≥0.5 mg/dL from baseline, so no additional blood samples were obtained at 7days (±24 hours) postcontrast. Data were not collected||||||
1458019|NCT00793169|Primary|The Number of Subjects With Detectable Serum Lidocaine Concentrations (<0.1 ug/mL) at Each Blood Draw.||6 hours|Analysis was per protocol.|||Participants|||Number
1458020|NCT00793104|Secondary|MRI Evaluation Score|MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.|24 months||||units on a scale||Standard Deviation|Mean
1458021|NCT00793104|Secondary|International Knee Documentation Committee (IKDC) at 24 Months.|The International Knee Documentation Committee scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months||||units on a scale||Standard Deviation|Mean
1458022|NCT00793104|Secondary|Lysholm With Tegner Score|The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.|24 months||||units on a scale||Standard Deviation|Mean
1458023|NCT00793104|Secondary|Current Health Assessment|Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0–100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months, MRI only at 12 and 24 months||||units on a scale||Standard Deviation|Mean
1458024|NCT00793104|Primary|The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months|The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0–100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|24 months||||units on a scale||Standard Deviation|Mean
1458025|NCT00792948|Other Pre-specified|MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry|Correlation between the two measures of MRD measured on the same remission specimens will be examined using scatterplots and correlation analysis. The prognostic effect for relapse of each measure will be illustrated using cumulative incidence plots, and estimated using Cox regression models. This outcome will be reported as funding allows.|Up to 5 years|||||||
1458026|NCT00792948|Other Pre-specified|Overall Survival (OS)|OS will be estimated using the method of Kaplan-Meier.|From the date of initial registration on the study until death from any cause, assessed up to 5 years|Analysis includes eligible patients who received treatment.|||Probability of surviving 12 months||95% Confidence Interval|Number
1458027|NCT00792948|Secondary|Continuous Complete Remission (CCR) Rate|Will be testing using an exact binomial test|18 months|Patients who had not received prior ALL therapy|||percentage of participants||95% Confidence Interval|Number
1458028|NCT00792948|Primary|Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation|Will be estimated using the method of Kaplan-Meier.|12 months|Patients who received allogeneic stem cell transplant|||Probability of 12-month RFS||95% Confidence Interval|Number
1458029|NCT00792935|Primary|Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)|"Hypoglycemic episodes are defined as either a fingerstick glucose~measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia."|Baseline to Week 6|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941 or glimepiride.|||participants|||Number
1458030|NCT00792935|Primary|Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose|"Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The weighted mean was used to avoid over-representation of post-meal glucose values."|Baseline and Week 6|The full analysis set (FAS) population included all randomized participants who had efficacy measurements at baseline or a post-randomization visit).|||mg/dL||95% Confidence Interval|Least Squares Mean
1458031|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months|"100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia.~50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.~Outcomes are reported at the community level because raw data could not be accessed.~There is no way to determine how many participants were examined in each arm."|3 years|We analyzed and reported the results of the trial at community level.|||community|community|Standard Deviation|Mean
1458032|NCT00792922|Primary|Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline|"Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.~The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination."|At baseline|"At baseline 8 communities were randomized to each arm in Tanzania, 12 communities were randomized to each arm in Gambia and Niger.~Stop rule could not be applied in Tanzania.Communities in stop arm were moved to ≥90% coverage or 80%-89% coverage with azithromycin target arm and only main effect of coverage was analyzed in Tanzania."|||community|community|Standard Deviation|Mean
1458033|NCT00792909|Secondary|Number (%) of Subjects With Serious Adverse Events|A serious adverse event (SAE) was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = occurrence of a SAE, regardless of relationship to vaccination.|During the 31-day period following vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1458034|NCT00792909|Secondary|Number (%) of Subjects With Unsolicited Adverse Events|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any = occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1458035|NCT00792909|Secondary|Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/ fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and Fever (rectal temperature ≥ 38.0 °C). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 drowsiness = drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = crying that could not be comforted/ prevented normal everyday activities. Grade 3 loss of appetite = not eating at all. Grade 3 fever = rectal temperature > 40.0°C.|During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1458036|NCT00792909|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed local symptoms were pain, redness and swelling. Any = occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = crying when limb was moved/ spontaneously painful. Grade 3 Redness/ Swelling = Redness/ swelling at injection site greater than (>) 30 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed Group|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1458037|NCT00792909|Secondary|Number of Subjects With B-cells Detection in the Unprimed Group|Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1.|Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants||Standard Deviation|Mean
1458038|NCT00792909|Secondary|Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2|Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to and 7-10 days post- additional dose.|Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants||Standard Deviation|Mean
1458039|NCT00792909|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group|ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1458040|NCT00792909|Secondary|Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2|ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1458041|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group|Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1458042|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2|Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1458043|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458044|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458045|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458046|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458065|NCT00792701|Secondary|Relationship Between RRM1 and ERCC1 Expression in the Formalin-fixed and Paraffin-embedded Tumor Specimens.|RRM1 and ERCC1 protein levels are expressed as a simple score with no units.|From time of registration to maximum of 2 years|Protein expression relationships were analyzed in the overall patient population, and not by arm.|||Scores||Full Range|Median
1459363|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|5 years|||||||
1458047|NCT00792909|Secondary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458048|NCT00792909|Secondary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and19A (ANTI-6A and19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458049|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1458050|NCT00792909|Secondary|Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2|Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1458051|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458052|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.2 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458053|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458061|NCT00792805|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.|Week 12 + 1 day, Day 85|Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized to impute missing data.|||Liters||Standard Error|Least Squares Mean
1458062|NCT00792701|Other Pre-specified|Relationship Between RNA and Protein Expression of RRM1 and ERCC1||From time of registration to maximum of 2 years||||Scores||Full Range|Median
1458054|NCT00792909|Secondary|Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL..|1 month after booster dose (Month 10) – in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||Participants|||Count of Participants
1458055|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One week after vaccination at Month 34+7 days (Mth34+D7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458056|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|Pre-additional dose at Month 34 in the current study (Month 34)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458057|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|1 month after booster dose (Month 10) – in primary study (105539)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458058|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One month after dose 2 (Month 3)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458059|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.|One week after dose 1 (Day 7)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458060|NCT00792909|Primary|Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group|Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.|Pre-vaccination (PRE/ Day 0)|The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
1458063|NCT00792701|Other Pre-specified|Generation of Results on in Situ Protein Expression and Other Assays for Genes Involved in Drug Efficacy||From time of registration to maximum of 2 years|Due to lack of funding, the protein expression data were never collected. Thus, this outcome could not be analyzed.||||||
1458064|NCT00792701|Other Pre-specified|Analytical Performance of the Biomarker Assay||From time of registration to maximum of 2 years|Due to lack of funding, the assay was never performed. Thus, this outcome could not be analyzed.||||||
1458066|NCT00792701|Secondary|Frequency and Severity of Toxicities as Assessed by NCI CTCAE v3.0|Patients in the active monitoring arm were not followed for adverse events.|From time of registration to maximum of 2 years|"Number of Subjects With Greater Than Grade 2 Toxicity~Patients in the active monitoring arm were not followed for adverse events."|||participants|||Number
1458067|NCT00792701|Secondary|Two-year Disease-free Survival||From time of registration to maximum of 2 years||||percentage of participants||95% Confidence Interval|Number
1458068|NCT00792701|Primary|Feasibility of Pharmacogenomics-based Treatment Assignment in the Cooperative Group Setting|Feasibility will be assessed both by accrual rate and the percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.|From time of registration to 84 days after surgical resection.|Percentage of patients successfully assigned to adjuvant chemotherapy or active monitoring.|||Participants|||Count of Participants
1458069|NCT00792688|Secondary|Cosmesis/11-point Likert Scale|The cosmetic effect on each lower eyelid using an 11-point Likert Scale (0 = not healed and 10 = healed).|At 1 month following the initial treatment.||||scores on a scale||Standard Deviation|Mean
1458070|NCT00792688|Primary|Time to Complete Wound Closure (Epithelialization)|Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject’s wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.|Over the course of 1 month following the initial treatment.|Analysis was Per Protocol.|||days||Standard Deviation|Mean
1458071|NCT00792636|Secondary|Number of Participants Withdrawn From the Study Due to Blood Pressure Changes|The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
1458072|NCT00792636|Secondary|Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||days||Full Range|Median
1458073|NCT00792636|Secondary|Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure|Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||days||Full Range|Median
1458074|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg|The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
1458075|NCT00792636|Secondary|Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study|The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population|||participants|||Number
1458076|NCT00792636|Secondary|Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||participants|||Number
1458095|NCT00792623|Primary|Number of Subjects With a Varicella Vaccine Response|Vaccine response defined for initially seropositive subjects as having an antibody titer at 8 months post-transplantation >4 fold the pre-vaccination antibody titer.|At 8 months post-transplantation = 1.5 months post second dose of vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.|||Participants|||Count of Participants
1458390|NCT00790569|Primary|Rates of Smoking Cessation Continuous From First Quit Day to 6 Months|Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months|6-Months||||participants|||Number
1458077|NCT00792636|Secondary|Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements|The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine.|Baseline to End of Study (6-month study duration)|ITT Population. Only participants with valid blood pressure measurements were analyzed.|||participants|||Number
1458078|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1458079|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1458080|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1458081|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence.|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home blood pressure assessment.|||mmHg||95% Confidence Interval|Least Squares Mean
1458082|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Deviation|Mean
1458083|NCT00792636|Secondary|Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Error|Mean
1458111|NCT00792103|Secondary|Photophobia Free|Photophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participant|||Number
1458084|NCT00792636|Primary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen|The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of investigational product and had at least one valid post-baseline at-home BP assessment. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1458085|NCT00792636|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen|The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM).|Baseline and Month 6|ITT Population. Mean BP values were not available for all participants at baseline and Month 6 due to participant drop-out or to an inadequate number of BP collections.|||mmHg||Standard Deviation|Mean
1458086|NCT00792623|Secondary|Number of Subjects With Serious Adverse Events|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Over the active phase of the study (up to Month 24)||||Participants|||Count of Participants
1458087|NCT00792623|Secondary|Occurrence of Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 43-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.|||Participants|||Count of Participants
1458088|NCT00792623|Secondary|Number of Subjects With Any and Related Rash|Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related).|During the 43-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.|||Participants|||Count of Participants
1458089|NCT00792623|Secondary|Number of Subjects With Any Fever|Any = fever equal to or greater than 37.5 °C. Grade 3 fever = fever > 39.0 °C. Related = assessed by the investigator as related to the vaccination.|During the 43-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.|||Participants|||Count of Participants
1458090|NCT00792623|Secondary|Number of Subjects With Any Solicited Local Adverse Events|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 8-day follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort, which included subjects with at least one vaccination administered, only on those with their symtpom sheets completed after the respective dose.|||Participants|||Count of Participants
1458091|NCT00792623|Secondary|Anti-varicella Antibody Titers Above the Cut-off|Antibody titers were presented as geometric mean titers (GMTs)|At pre-transplantation (Month 0), pre-vaccination visit (4.5 Month post-transplantation), Month 5.5 and Month 7.5 post-vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1458092|NCT00792623|Secondary|Number of Subjects With Anti-varicella GMTs Avove the Cut-off|The cut-off titer was 1:4|At pre-transplantation (Month 0), pre-vaccination visit (4.5 Month post-transplantation), Month 5.5 and Month 7.5 post-vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.|||Participants|||Count of Participants
1458093|NCT00792623|Secondary|Number of Subjects With a Vaccine Response|Vaccine response defined for initially seropositive subjects as having an antibody titer at 6.5 months post-transplantation >4 fold the pre-vaccination antibody titer|A 6.5 months post-transplantation = 2 months post first dose of vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre- and post-vaccination.|||Participants|||Count of Participants
1458094|NCT00792623|Primary|Anti-varicella Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs)|At 8 months post-transplantation = 1.5 months post second dose of vaccination|The analysis was performed on the initially seropositive subjects from the total vaccinated cohort, i.e those with anti-varicella antibody titer >=1:4 prior to vaccination and available results at pre-vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1458391|NCT00790569|Primary|Carbon Monoxide (CO)-Confirmed 7-day Abstinence|Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.|6-Months||||participants|||Number
1462723|NCT00760383|Primary|Stair Time up||6 weeks||||seconds||Standard Error|Mean
1458096|NCT00792610|Primary|Hepatitis B Surface Antibody Seroprotective Rate(Seroprotective: for Those Who Had Anti-HBs(Surface Antibody Against Hepatitis B) Titer Higher Than 10 mIU/mL)|The anti-HBs(Surface antibody against Hepatitis B) status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of hepatitis B vaccine. And then the seroprotective rate for anti-HBs(numbers of those who had anti-HBs titer higher than 10 mIU/mL/all participants numbers) was calculated respectively.|7 months||||participants|||Number
1458097|NCT00792428|Secondary|Wolf-Motor-Function-Test|"The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task, or similar as accurate. The average time in seconds is then log10 transformed."|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days||||units on a scale (log(sec))||Standard Deviation|Mean
1458098|NCT00792428|Primary|Fugl-Meyer Assessment of Upper Extremity Motor Impairment|This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.|Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days||||units on a scale [0-66]||Standard Deviation|Mean
1458099|NCT00792298|Post-Hoc|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Period 1 (To Exclude Carryover Effect)|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset. In order to evaluate the efficacy of suvorexant on LPS excluding the influence of a carryover effect from Period 1 to Period 2, an ad hoc analysis of LPS restricted to Period 1 data was also performed.|Night 1 (Period 1 only) and end of Week 4 (Period 1 only)|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1458100|NCT00792298|Secondary|LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2|LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1458101|NCT00792298|Secondary|LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2|WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||minutes||Standard Error|Least Squares Mean
1458102|NCT00792298|Primary|LS Mean Sleep Efficiency (SE) During Periods 1 and 2|SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100|Night 1 and end of Week 4|Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.|||percent of time in bed||Standard Error|Least Squares Mean
1458103|NCT00792259|Primary|Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device|"The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.~Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer"|30 Minutes||||µm||Standard Deviation|Mean
1458104|NCT00792116|Primary|Math Grades||14 week (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||average percentage correct||Standard Deviation|Mean
1458105|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS).|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|14 weeks (end of the semester)|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||percentile||Standard Deviation|Mean
1458106|NCT00792116|Secondary|State Anxiety Scores on the State Trait Anxiety Index for Children (STAIC).|The STAIC is a scale that distinguishes between a situationally based anxiety and a general intrinsic inclination towards experiencing feelings of anxiety|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
1458107|NCT00792116|Secondary|Scores on the Math Anxiety Rating Scale for Adolescents (MARS-A)|he MARS-A (12) is a 98-item scale that lists various everyday situations in which adolescents may have to use mathematics.|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
1458108|NCT00792116|Secondary|Math Scores on the Woodcock Johnson III Tests of Achievement (WJ-III)|The WJ-III (10) is a standardized test battery used to assess an individual’s academic strengths and weaknesses. For purposes of the current study, students were given the 4 math subtests of the WJ-III.|the beginning of a school semester and 14 weeks later (the end of a school semester)|||||||
1458109|NCT00792116|Primary|Math Grades||baseline (the beginning of a school semester )|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||average percentage correct||Standard Deviation|Mean
1458110|NCT00792116|Primary|Math Scores on the Texas Assessment of Knowledge and Skills (TAKS)|The TAKS test is a statewide standardized test administered to all Texas schoolchildren (15). The TAKS assesses reading, math, science, and social studies for 8th grade students; however, the current study analyzed only math scores.|the beginning of a school semester|106 participants were analyzed. One particiapant relocated to another school and one participant was removed by the teacher for discipline reasons.|||percentile||Standard Deviation|Mean
1474756|NCT00670462|Secondary|Triglycerides||baseline, 6, 12, 18, and 30 months|||||||
1458112|NCT00792103|Secondary|Phonophobia Free|Phonophobia free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
1458113|NCT00792103|Secondary|Nausea Free|Nausea free at two hours after patch activation.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
1458114|NCT00792103|Primary|Subject Self-examination of Skin Irritation|For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).|24 hours post patch activation|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea).|||scores on a scale|Participants|Standard Deviation|Mean
1458115|NCT00792103|Secondary|Pain Relief|Headache pain relief (no pain or mild headache pain) at two hours post activation of NP101.|2 hours|Per protocol, the intent-to-treat population was defined as all subjects who applied and activated at least one NP101 study patch and had at least one post baseline assessment for each migraine symptom (pain, photophobia, phonophobia, and nausea). Two treated subjects in the safety population did not meet this criteria.|||participants|||Number
1458116|NCT00791999|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1458117|NCT00791999|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 316 subjects (72 CDP 100 mg, 82 CDP 200 mg, 85 CDP 100 mg, 77 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1458118|NCT00791973|Secondary|Total Eye Symptom Scores After Antigen Challenge|Watery and itchy eye symptoms will be scored based on the following scale: 0=no symptoms, 1= mild, 2= moderate, 3= severe|After one week of treatment wtih veramyst or placebo||||units on a scale||Inter-Quartile Range|Median
1458119|NCT00791973|Primary|Change in Tryptase Level From Baseline to Post-antigen Challenge|Tryptase levels (mcg/L) were measured from nasal lavages|After one week of treatment wtih veramyst or placebo||||mcg/L||Inter-Quartile Range|Median
1458120|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|10 weeks|The analysis population consists of the 58 subjects with 10 week post-procedure SNOT-20 scores available for analysis.|||scores on a scale||Standard Deviation|Mean
1458121|NCT00791934|Secondary|Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline|The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.|1 year|The analysis population consists of the 47 subjects with 1 year post-procedure SNOT-20 scores.|||scores on a scale||Standard Deviation|Mean
1458122|NCT00791934|Secondary|Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg|Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).|10 weeks post-procedure|The analysis population includes paired data for 53 of the 63 subjects with intraocular pressure (IOP) evaluations available for analysis.|||participants|||Number
1458123|NCT00791934|Secondary|Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)|The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.|10 weeks post surgery|The analysis population includes paired data for 53 subjects with baseline and 10 week visual acuity data available for analysis.|||participants|||Number
1458200|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1458124|NCT00791934|Primary|Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.|The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.|10 weeks post-procedure|A total of 58 of the 63 subjects had paired baseline and 10 week post-procedure CT scans available for analysis.|||scores on a scale||Standard Deviation|Mean
1458125|NCT00791921|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 24|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 24|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1458126|NCT00791921|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)|Baseline, Week 12|All 230 subjects (116 CDP 200 mg, 114 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of participants|||Number
1458127|NCT00791908|Primary|Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters|Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).|Baseline and 3 months||||Units on a scale||Full Range|Mean
1458128|NCT00791817|Primary|Cmax|Maximum plasma concentration after a single dose|over 12 hours||||ng/mL||Standard Deviation|Geometric Mean
1458129|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1458130|NCT00791778|Other Pre-specified|EQ-5D VAS Score at End of Treatment|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1458131|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1458132|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 5|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1458133|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D VAS ranges from -100 (most deterioration from baseline) to 100 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1458134|NCT00791778|Other Pre-specified|EQ-5D VAS Score at Cycle 3|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1458135|NCT00791778|Other Pre-specified|EQ-5D Visual Analogue Scale (VAS) Score at Cycle 1/Baseline|The EQ-5D also contains a VAS, which records the respondent’s self-rated health status on a vertical graduated scale. The scale ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
1458148|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1465718|NCT00735306|Primary|Tarceva Maximum Tolerated Dose in mg|Tarceva maximum tolerated dose in mg|1 yr||||mg|||Number
1458136|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at End of treatment minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1458137|NCT00791778|Other Pre-specified|EQ-5D Index Score at End of Treatment|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1458138|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 5 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1458139|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 5|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1458140|NCT00791778|Other Pre-specified|Change From Baseline in EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index. The change is calculated as score at Cycle 3 minus baseline score. The change in EQ-5D index ranges from -1.594 (most deterioration from baseline) to 1.594 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1458141|NCT00791778|Other Pre-specified|EQ-5D Index Score at Cycle 3|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1458142|NCT00791778|Other Pre-specified|EuroQol-5D (EQ-5D) Index Score at Cycle 1/Baseline|The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. These five health dimensions are summarized into a single score, the EQ-5D index score which ranges from -0.594 (worst) to 1 (best) when the United Kingdom (UK) weights are applied.|At Cycle 1 (4 weeks per Cycle)/baseline|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
1458143|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at End of treatment minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1458144|NCT00791778|Other Pre-specified|FOSI Total Score at End of Treatment|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At End of treatment (up to Cycle 33, 4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at end of treatment|||Scores on a scale||Standard Deviation|Mean
1458145|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 5 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1458146|NCT00791778|Other Pre-specified|FOSI Total Score at Cycle 5|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 5 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 5|||Scores on a scale||Standard Deviation|Mean
1458147|NCT00791778|Other Pre-specified|Change From Baseline in FOSI Total Score at Cycle 3|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The change is calculated as score at Cycle 3 minus baseline score. The change in FOSI total score ranges from -32 (most deterioration from baseline) to 32 (most improvement from baseline).|Baseline and Cycle 3 (4 weeks per Cycle)|PRO analysis set=the FAS population with evaluable PRO assessments at baseline and at Cycle 3|||Scores on a scale||Standard Deviation|Mean
1458392|NCT00790569|Primary|Self- Reported 7-day Abstinence|Number of participants with self-reported, 7-day abstinence at 6-months|6 Months||||participants|||Number
1474757|NCT00670462|Secondary|HDL||baseline, 6, 12, 18, and 30 months|||||||
1458149|NCT00791778|Other Pre-specified|Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Ovarian Symptom Index (FOSI) Total Score at Cycle 1/Baseline|The FOSI is an 8-item index derived from the FACT-Ovarian Cancer (FACT-O) to measure symptom response to treatment for ovarian cancer. The FOSI total score ranges from 0 (severely symptomatic) to 32 (asymptomatic).|At Cycle 1 (4 weeks per Cycle)/baseline|Patient-reported outcomes (PRO) analysis set=the FAS population with evaluable PRO assessments at baseline and at least one post-baseline assessment|||Scores on a scale||Standard Deviation|Mean
1458150|NCT00791778|Secondary|Overall Survival (OS)|The OS time was measured from the date of randomization until the date of death due to any cause. Patients who were alive at the time of analysis were censored at the date of the last contact (last time the patient was known to be alive).|From randomization of the first patient until 32.5 months later|FAS=all randomized participants|||Days||95% Confidence Interval|Median
1458151|NCT00791778|Secondary|Time to First Pathologic CA-125 (Cancer-associated Tumor Marker) Serum Level|Time from randomization to the first documented increase of CA-125 above the upper limit of normal. Patients without pathologic CA-125 increase at the time of analysis were censored at their last date of evaluation of CA-125.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Per protocol set (PPS)=all randomized participants who had normal CA-125 serum level at baseline and at least one post-baseline CA-125 assessment|||Days||95% Confidence Interval|Median
1458152|NCT00791778|Primary|Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment|Time from randomization to the first documented disease progression by radiological or pathologic assessment or death due to any cause whichever occurred first. For patients who had not progressed or died at the time of analysis, PFS was censored at the date of their last evaluable tumor scan.|From randomization of the first patient until 32.5 months later, assessed every 8 weeks|Full analysis set (FAS)=all randomized participants|||Days||95% Confidence Interval|Median
1458153|NCT00791765|Secondary|Patient Satisfaction With Treatment at Week 12|This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from “very dissatisfied” to “very satisfied”) to indicate his or her level of satisfaction with the medication’s control of psoriasis.|12 Weeks|Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used.|||participants|||Number
1458154|NCT00791765|Secondary|Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12|Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 24|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation.|||Percent change||Standard Error|Mean
1458155|NCT00791765|Secondary|Percentage of Participants With PSSI 75% Response at Week 12|Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.|Baseline and Week 12|Intention-to-Treat with available data; last observation carried forward (LOCF) imputation|||Percentage of participants|||Number
1458156|NCT00791765|Primary|Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12|The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.|Baseline and Week 12|Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used.|||Percent change||Standard Error|Mean
1458157|NCT00791700|Secondary|Optimized Background Treatment (OBT) Susceptibility Scores (Net/Overall) by Outcome|Outcome (Response, PDVF or other/remainder) was summarized by the total ARV activity of the background regimen using simple and weighted totals (TOBT and p-wTOBTss, respectively) in the aggregate, categorized as 0, 1, ≥2 (TOBT) and 0 0.5, 1 1.5 and ≥2 (p-wOBTss) respectively, as well as by screening genotype. Six participants (Response: n=5; Other failure: n=1) failed to have successful PhenoSense GT analysis at screening, and so a net susceptibility score was not generated. One more participant was not included in the wOBTss analysis due to failed phenotype analysis. However, net susceptibility scores were imputed for simple analysis based on genotype. Susceptibility scores indicate the level resistance to the study medication. Scores include: 1 = susceptible and potential low-level resistance; 0.5 = low and intermediate-level resistance; 0 = high-level resistance.|48 weeks|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants|||Number
1458158|NCT00791700|Secondary|Summary of the Emergence of Reverse Transcriptase Inhibitor (RTI) and Protease Inhibitor (PI) Resistance Associated Mutations (RAMs) Between Screening and On-Treatment Confirmed PDVF: Total and by Cohort Prior to Week 48|Phenotypic and genotypic susceptibility to reverse transcriptase and protease inhibitors was evaluated at screening using the Monogram Biosciences PhenoSense™ GT (PSGT) assay. Samples from a confirmatory PDVF visit or early termination of MVC were planned to be analyzed if the plasma HIV-1 RNA was ≥400 copies/mL. Participants with more than one mutation are counted more than once.|48 weeks|"The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).~One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment."|||Number of participants|||Number
1458201|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%|The number of participants who had a COPD exacerbation (defined as worsening of COPD symptoms) requiring hospitalization was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1458159|NCT00791700|Secondary|Shift Table of Viral Tropism Between Screening and Confirmed PDVF Prior to Week 48|Virus tropism was determined using the Monogram Biosciences Trofile™ viral tropism assay. A shift table of the change in detected tropism from screening to the time of failure was produced in the aggregate and also broken down by age cohort.|Screening and Week 48|Participants who experienced confirmed PDVF through Week 48 with sufficient plasma HIV-1 RNA for virology analysis while receiving MVC. One participant was excluded from summary tables as classified as MSDF response; one participant was analyzed after stopping treatment.|||Number of participants|||Number
1458160|NCT00791700|Secondary|Protocol Defined Virologic Failure|"The occurrence of any one of the following criteria would constitute Virologic failure:~A=Decrease from Baseline plasma HIV-1 RNA <1 log10 and plasma HIV-1 RNA >400 copies/mL starting at Week 12 and confirmed at consecutive Week 16; B=Decrease from Baseline plasma HIV-1 RNA <2.0 log10 and plasma HIV-1 RNA >400 copies/mL at Week 24 OR plasma HIV-1 RNA >10,000 copies/mL on and after Week 24, and confirmed within 14 to 21 days; C=Increase from nadir plasma HIV-1 RNA of >=1 log10 (>=1,000 copies/mL if nadir plasma HIV-1 RNA <48 copies/mL) at any time, and confirmed within 14 to 21 days."|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Number of participants|||Number
1458161|NCT00791700|Secondary|Change From Baseline in CD4+ Percent (%) at Weeks 24 and 48|Change from baseline in CD4 % to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||percentage of CD4+ cells||Standard Deviation|Mean
1458162|NCT00791700|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 24 and 48|Change from baseline in CD4 cell count to Week 24 and Week 48 were tabulated in aggregated and broken down by age cohort using summary statistics.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||cells/mm^3||Standard Deviation|Mean
1458163|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Log10 Copies/mL) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||Log10 Copies/mL||Standard Deviation|Mean
1458164|NCT00791700|Secondary|Summary of Change From Baseline in HIV-1 RNA (Original) by Visit|Plasma HIV-1 RNA was determined using the Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (lower limit of quantification [LLOQ] <48 copies/mL). Blood samples were taken at the time points indicated in the participant evaluation schedule. Screening HIV-1 RNA >1000 copies/ml was used to determine eligibility for the study.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). LOCF was used to impute missing values.|||copies/mL||Standard Deviation|Mean
1458165|NCT00791700|Secondary|Percentage of Participants With >= 1.0 log10 Reduction in HIV-1RNA Concentration From Baseline to Week 24 and Week 48|Percentage of subjects with at least a 1.0 log10 reduction in HIV-1 RNA from baseline to Week 24 and Week 48 were tabulated.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4). Last Observation Carried Forward (LOCF) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
1458166|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies/mL and <48 Copies/mL Using the Time to Loss of Virologic Response Algorithm (TLOVR) at Week 48|TLOVR is defined as the time from first dose of study medication (Day 1) until the time of virologic failure using the a TLOVR algorithm.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants|||Number
1458167|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels < 48 Copies/mL at Weeks 24 and 48 Using MD=F Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants||95% Confidence Interval|Number
1458168|NCT00791700|Secondary|Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Weeks 24 and 48 Using Missing, Discontinuation = Failure (MD=F)Approach|Participants who have been discontinued from the study, have been lost to follow-up, or have missing HIV-1 RNA data prior to the time point of interest were considered to have HIV-1 RNA levels > lower limit of quantification (LLOQ) . This will be referred to as [non-completer = failure; NC=F] or [missing, discontinuation = failure; MD=F]. The proportion of participants (100*n/N) is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||Percentage of participants||95% Confidence Interval|Number
1458169|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <48 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <48 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||percentage of participants|||Number
1458199|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1458170|NCT00791700|Secondary|Percentage of Participants With HIV‑1 RNA <400 Copies/mL Through Week 48 (MSDF)|The proportion of participants who achieved HIV-1 RNA <400 copies/mL at week 24 or 48 was assessed according to Food and Drug Administration’s (FDA’s) Missing, Switch, Discontinuation’=Failure (MSDF) Snapshot algorithm. The algorithm uses the plasma HIV-1 RNA in the Week 24 or 48 visit window, follows the “virology-first principle” and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure. The percentage of participants is reported below.|Week 24 and Week 48 post-treatment.|The FAS will consist of all participants who receive at least one dose of study medication (same as APS4).|||percentage of participants|||Number
1458171|NCT00791700|Primary|Treatment Discontinuation Secondary to Serious Adverse Event (SAE) Related to Study Drug|The primary reason for a participant discontinuing from study drug or the clinical study was recorded in the source documents as well as the case report form. A discontinuation had to be reported immediately to the study medical monitor or his/her designated representative if it was due to an SAE.|Week 48|The FAS consisted of all participants who received at least 1 dose of study drug (same as APS 4).|||participants|||Number
1458172|NCT00791700|Primary|Incidence and Severity of Grade 3 and Grade 4 Treatment-Emergent Adverse Events (All Causality)|Safety was assessed by spontaneous reports, physical examination and laboratory test results in all participants who received at least 1 dose of study drug. The investigator used the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs.|48 weeks|Safety analysis was performed on all participants who received at least 1 dose of study drug.|||Number of events|||Number
1458173|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - Tmax (Time at Maximum Concentration)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (Tmax) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.|||hr||Full Range|Median
1458174|NCT00791700|Primary|PK Parameters for Stage 1 Participants Enrolled in Stage 2 – Week 2 Results for Stage 2 Doses - AUCtau (Area Under the Curve at Steady State)|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters (AUCtau) at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Correlations between MVC PK and efficacy as well as compliance were also assessed.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of APS 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1458175|NCT00791700|Primary|Pharmacokinetic (PK) Parameters for Participants With Data in Stage 1 Enrolled in Stage 2 – Week 48|A PK analysis was performed using PK data from participants that participated in Stage 1 (PK Populations 2 and 3) where intensive maraviroc (MVC) PK data were available at Week 2. The primary aim of this analysis was to describe and summarize MVC PK parameters at Week 2 and Week 48 by cohort and Optimized Background Treatment (OBT) group. Geometric Coefficient of Variation is defined as the geometric standard deviation to the power of the reciprocal of the geometric mean.|Week 2 and Week 48 (0, 1, 2, 4, 6, 8, 12 hours post-dose)|PK Population 2 (subset of Analysis Population Set [APS] 1) consisting of all Stage 1 participants who had a Week 2 full PK profile; PK Population 3 (subset of APS 1) consisting of all Stage 1 participants who had an approved dose for Stage 2 / met the PK target.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1458176|NCT00791661|Secondary|24-hour Weighted Mean Glucose (WMG) Concentration|Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.|Up to 36 hours|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||mg/dL||95% Confidence Interval|Least Squares Mean
1458177|NCT00791661|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|up to approximately 17 days|Participants who received study drug. The same participant may appear in more than one treatment arm.|||participants|||Number
1458178|NCT00791661|Secondary|Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006|The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||hours||Standard Deviation|Mean
1458179|NCT00791661|Secondary|Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||hours||Full Range|Median
1458180|NCT00791661|Secondary|Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006|The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM||Standard Deviation|Mean
1458181|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006|AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM*hr||Standard Deviation|Mean
1458182|NCT00791661|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006|AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.|Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)|Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.|||nM*hr||Standard Deviation|Mean
1458183|NCT00791661|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)|Participants who received study drug. The same participant may appear in more than one treatment arm.|||participants|||Number
1458184|NCT00791648|Secondary|Mitochondrial Function|mtDNA copy number, lactate / pyruvate ratio, PGC-1alpha RNA expression|at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||2018-07-31|07/2018||||
1458185|NCT00791648|Secondary|Plasma and Urine Markers of Oxidative Stress (f2-Isoprostanes, Isofurans)||at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||2018-07-31|07/2018||||
1458186|NCT00791648|Secondary|Number of Participants That Died||until postoperative hospital discharge (about 7 days)||||Participants|||Count of Participants
1458187|NCT00791648|Secondary|Number of Participants With Stroke||while in ICU (about 2 days)||||Participants|||Count of Participants
1458188|NCT00791648|Secondary|Liver Enzyme: Aspartate Aminotransferase Level||postoperative day 1||||units/liter||95% Confidence Interval|Median
1458189|NCT00791648|Secondary|Plasma Markers of Inflammation||at randomization, anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.||2018-07-31|07/2018||||
1458190|NCT00791648|Secondary|Urine Markers of Renal Injury||at randomization, anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, 12 hours postop, and Post op Day (POD) 1, 2, 3.||2018-04-30|04/2018||||
1458191|NCT00791648|Secondary|Number of Participants Requiring Dialysis||while in ICU (about 2 days)||||Participants|||Count of Participants
1458192|NCT00791648|Primary|Number of Participants With Delirium||while in ICU (about 2 days)||||Participants|||Count of Participants
1458193|NCT00791648|Primary|Number of Participants With Acute Kidney Injury||postoperative day 2||||Participants|||Count of Participants
1458194|NCT00791557|Primary|The Efficacy of Infliximab in Pyoderma Gangrenosum in Adult Subjects Who Have Inflammatory Bowel Disease|Outcome was measured by clinical assessment of pyoderma gangrenosum. The number of patients who had improvement and/or clearance of the pyoderma grangrenosum after the infusions and through the follow up visit was assessed.|Week 26|Subjects who completed all required transfusions of infliximab were analyzed.|||participants|||Number
1458195|NCT00791518|Secondary|Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups|The number of participants with the indicated affected medical conditions were counted.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1458196|NCT00791518|Secondary|Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||puffs||Standard Error|Mean
1458197|NCT00791518|Secondary|Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%|The average number of puffs from all short-acting bronchodilators used in the past 2 weeks was calculated.|Day 1 of a 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||puffs||Standard Error|Mean
1458198|NCT00791518|Secondary|Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%|The number of participants with a COPD exacerbation (worsening of COPD symptoms) requiring treatment with oral corticosteroids and/or antibiotics was calculated.|Day 1 of 1-day study|All participants enrolled in the study who had an acceptable post-albuterol FEV1 measure|||participants|||Number
1473877|NCT00678379|Secondary|Total Time Until Discharge From Hospital.||Day of Surgery||||minutes||Full Range|Median
1458202|NCT00791518|Secondary|Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <50% and >=50% predicted|||points on a scale||Standard Error|Mean
1458203|NCT00791518|Secondary|Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%|The 5-point mMRC Dyspnea Scale measures the level of dyspnea (trouble breathing) experienced by participants. Scores range from 0 (none) to 4 (very severe).|Day 1 of a 1-day study|All participants enrolled in the study who had an mMRC score with post-albuterol FEV1 <80% and >=80% percent predicted|||points on a scale||Standard Error|Mean
1458204|NCT00791518|Secondary|Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios|The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).|Day 1 of a 1-day study|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||participants|||Number
1458205|NCT00791518|Secondary|Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who met spirometric criteria for chronic obstructive pulmonary disease (COPD) and who had a post-albuterol FEV1 (the amount of air expelled from the lungs in one second after a full inspiration) <50% predicted normal was calculated. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||percentage of participants|||Number
1458206|NCT00791518|Primary|Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal|The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) <80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.|Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)|All participants enrolled in the study who had a post-albuterol FEV1 measurement. Some participants had unacceptable post-albuterol spirometry measurements and were not included in this analysis.|||percentage of participants|||Number
1458207|NCT00791492|Other Pre-specified|Number of Participants Who Discontinued Due to Clinical or Laboratory Adverse Events|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Month 12|Safety population included participants who received at least one dose of study medication.|||participants|||Number
1458208|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Holter Monitor Findings|Clinically significant Holter monitor findings included: atrial fibrillation/flutter, atrial tachycardia, non-sustained ventricular tachycardia (<30 beats), sustained ventricular tachycardia (>= 30 beats), sinus pause (RR >2.0 second, where RR=60/heart rate), ventricular premature contractions.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.|||participants|||Number
1458209|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings included: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. ‘n’ signifies participants for this measure at specified time point for each arm group.|||participants|||Number
1458210|NCT00791492|Other Pre-specified|Number of Participants With Clinically Significant Treatment-emergent Echocardiography (ECHO) Findings|Clinically significant ECHO findings included: LV posterior wall thickness greater than or equal to (>=)13 mm, LV septal thickness >= 13 mm, right ventricular thickness >= 7 mm, ratio of peak mitral early diastolic and atrial contraction velocity (E/A ratio) >= 2, prime septal (E/E) >15, ejection fraction < 50 percent (%), E deceleration time <= 150 millisecond (ms), isovolumic relaxation time (IVRT) <= 70 ms, any valve thickening (> trace regurgitation in mitral, aortic, pulmonary, or tricuspid valves), abnormal respiratory variation of inferior vena cava, pericardial effusion.|Baseline, Day 1 up to Month 12 (anytime on-treatment)|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||participants|||Number
1458211|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to Grade 3|AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.|||participants|||Number
1458393|NCT00790556|Other Pre-specified|Hepatic Glucose Production (HGP) at Baseline||Baseline|Subjects who discontinued were not used in the analysis.|||mg/kg/min||Standard Deviation|Mean
1458212|NCT00791492|Other Pre-specified|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|An Adverse Event (AE) was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug, up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 30 days after last dose of study medication|Safety population included participants who received at least one dose of study medication.|||participants|||Number
1458213|NCT00791492|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer|TTR tetramer was assessed using a validated immunoturbidimetric assay. The Fraction of Initial (FOI) is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI.|Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1458214|NCT00791492|Secondary|Intraepidermal Nerve Fiber (IENF) Density|IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. It is used in diagnosing various neuropathic conditions.|Baseline|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||fibers/mm||Standard Deviation|Mean
1458215|NCT00791492|Secondary|Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week 6, Month 3, 6 and 12|NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||picogram/milliliter (pg/mL)||Full Range|Median
1458216|NCT00791492|Secondary|Change From Baseline in Troponin I Concentration at Week 6, Month 3, 6 and 12|Troponin I was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular [LV] wall stress).|Baseline, Week 6, Month 3, 6, 12|Safety population included participants who received at least one dose of study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants evaluable for this measure at the specified time point for each arm group.|||nanogram/milliliter (ng/mL)||Full Range|Median
1458217|NCT00791492|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Month 6 and 12|BMI was calculated by weight divided by height squared. mBMI was calculated by multiplying BMI by serum albumin levels to compensate for edema formation. A progressive decline in mBMI indicated worsening of disease severity.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
1458218|NCT00791492|Secondary|Change From Baseline in Summated 3 Score for Small Nerve Fiber Function at Month 6 and 12|Summated 3 Nerve Tests Small Fiber Normal Deviates Score (NTSFnds) included cooling threshold for the lower limbs, heat pain threshold for the lower limbs and HRDB. Total score range= -11.2 to 11.2, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1458219|NCT00791492|Secondary|Change From Baseline in Summated 7 Score for Large Nerve Fiber Function at Month 6 and 12|Summated 7 score: composite score included five Nerve Conduction Studies (NCS) attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with Vibration Detection Threshold (VDT) obtained in great toes, and Heart Rate Response to Deep Breathing (HRDB) value. Score was determined through reference to normal values for age, sex and height. Total score range= -26 to 26, where higher score=worse nerve function.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1458220|NCT00791492|Secondary|Change From Baseline in Norfolk Quality of Life – Diabetic Neuropathy (QOL-DN) Domain Scores at Month 6 and 12|Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1-7:scored as 1=symptoms present, 0=symptoms absent. Item 8-35:scored on 5-point Likert scale: 0=no problem,4=severe problem (except item 32: -2=much better, 0=about same, 2=much worse). Norfolk QOL-DN summarized in 5 domains(score range):physical functioning/large fiber neuropathy(-2 to 58), activities of daily living(ADLs) (0 to 20), symptoms(0 to 32), small fiber neuropathy(0 to 16), autonomic neuropathy(0 to 12); higher score=greater impairment,for each. Total score=-2 to138(higher score=worse QOL).|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1459364|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|4 years|||||||
1458221|NCT00791492|Secondary|Change From Baseline in Neuropathy Impairment Score - Lower Limb (NIS-LL) Score at Month 6 and 12|NIS-LL: assessed muscle weakness, reflexes and sensation; scored separately for left and right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) are scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) were scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS-LL score range 0-88, higher score=greater impairment.|Baseline, Month 6, 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure. ‘n’ signifies participants for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
1458222|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 12|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1458223|NCT00791492|Primary|Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy; Item 1 to 7: related to symptoms and presence of symptoms was assessed as 1 and absence was assessed as 0. Item 8-35: related to activities of daily living and scored on a 5-point Likert scale, where 0= no problem and 4= severe problem (except item 32, where -2= much better, 0=about the same, 2=much worse). TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life.|Baseline, Month 6|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1458224|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 12|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 12|ITT population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1458225|NCT00791492|Primary|Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6|Response to treatment indicated by either improvement(decrease from baseline) or stabilization(change from baseline of 0 to less than[<] 2) in NIS-LL score,based on mean of 2 scores in 1 week period.NIS-LL assessed muscle weakness,reflexes,sensation.Each item scored separately for left,right limbs.Components of muscle weakness:0(normal)-4(paralysis),higher score=more weakness;reflexes,sensation:0=normal,1=decreased,or 2=absent.Total NIS-LL score range 0-88,higher score=more impairment. For tafamidis-tafamidis group, NIS-LL baseline value of previous study FX-005(NCT00409175) used as reference.|Month 6|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had no more than 2 months interruption between studies FX-005 and FX-006. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1458226|NCT00791479|Secondary|Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265|The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|4 weeks, 8 weeks, 12 weeks|Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams [mg]) with evaluable pharmacokinetic data.|||nanograms*hour/milliliter (ng*h/mL)||Standard Deviation|Mean
1458227|NCT00791479|Secondary|Antibody Production and Effects to LY2189265|LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.|Baseline, 4 weeks, 12 weeks, 16 weeks|Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.|||participants|||Number
1458228|NCT00791479|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have body weight change from baseline data available.|||kilogram (kg)||Standard Error|Least Squares Mean
1458255|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1474758|NCT00670462|Secondary|Insulin||baseline, 6, 12, 18, and 30 months|||||||
1458229|NCT00791479|Secondary|Treatment Emergent Adverse Events|A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug.|||participants|||Number
1458230|NCT00791479|Secondary|Rate of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.|||Events per participant per year||Standard Error|Least Squares Mean
1458231|NCT00791479|Secondary|Number of Participants With Self-reported Hypoglycemic Events|Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 12 weeks|Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.|||participants|||Number
1458232|NCT00791479|Secondary|Change From Baseline in Blood Pressure (BP)|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood pressure change from baseline data available.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1458233|NCT00791479|Secondary|Change From Baseline in Pulse Rate|Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have pulse rate change from baseline data available.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1458234|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Heart Rate|Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have heart rate change from baseline data available.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1458235|NCT00791479|Secondary|Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.|||millisecond (msec)||Standard Error|Least Squares Mean
1458236|NCT00791479|Secondary|Change From Baseline in Insulin Sensitivity (HOMA2-%S)|Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.|||percentage of HOMA2-%S||Standard Error|Least Squares Mean
1458237|NCT00791479|Secondary|Change From Baseline in Beta-cell Function (HOMA2-%B)|Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
1458238|NCT00791479|Secondary|Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles|Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1458239|NCT00791479|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of <7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.|12 weeks|Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.|||percentage of participants|||Number
1458240|NCT00791479|Secondary|Change From Baseline in Fasting Blood Glucose|Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
1458241|NCT00791479|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.|Baseline, 4 weeks, 8 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1458242|NCT00791479|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.|Baseline, 12 weeks|Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
1458243|NCT00791388|Primary|t½,z Over a Dosing Interval (τ = 12 Hours)on Day 14|t½,z is the terminal exponential half-life; over a Dosing Interval (τ = 12 Hours)on Day 14|over a Dosing Interval (τ = 12 Hours) on Day 14||||hours||Standard Deviation|Mean
1458244|NCT00791388|Primary|Tmax Over a Dosing Interval (τ = 12 Hours) on Day 14|the time at which maximum plasma concentration occurred (Tmax) Over a Dosing Interval (τ = 12 Hours) on Day 14|12 Hours on Day 14||||hours||Standard Deviation|Mean
1458245|NCT00791388|Primary|Cmax Over a Dosing Interval (τ = 12 Hours)on Day 14|Maximum plasma concentration (Cmax) over a dosing interval (τ = 12 hours)on Day 14|12 hours on Day 14||||ng/mL||Standard Deviation|Mean
1458246|NCT00791388|Primary|AUCτ Over a Dosing Interval (τ = 12 Hours) on Day 14|the area under the plasma concentration-time curve over a dosing interval (τ = 12 hours) on Day 14 of Multiple Dose Oral Administration of PG-760564 Given Every 12 Hours|14 days|PG 760564 blood plasma concentrations were not measured for the placebo arm|||ng*h/mL||Standard Deviation|Mean
1458247|NCT00791336|Secondary|Safety and Tolerability of the Combined Treatment Regimen||7 weeks|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
1458248|NCT00791336|Secondary|Characterization of Overall and Disease-free Survival||long-term|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
1458249|NCT00791336|Primary|Pathologic Complete Response||30 days|Only 1 subject was enrolled and treated. Study was terminated due to poor enrollment. Data were not collected or analyzed due to study termination and low enrollment count (n=1).||||||
1458250|NCT00791323|Primary|Mean Prostaglandin E2 (PGE2) Aqueous Humor Levels|The mean level of PGE2 (a naturally occurring prostaglandin E2 in the eye that can cause inflammation and other complications) in the aqueous humor (the thin, watery fluid in the eye) 2 days following peripheral iridotomy (ocular surgery).|Day 3|Intent to Treat defined as all patients who started the study (randomized) with processed aqueous samples. Two patients in the Ketorolac 0.4% arm did not have aqueous humor samples processed.|||Picograms per milliliter (pg/ml)||Standard Deviation|Mean
1458251|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458252|NCT00791258|Secondary|Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458253|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458254|NCT00791258|Secondary|Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458256|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458257|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458258|NCT00791258|Secondary|Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458259|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458260|NCT00791258|Secondary|Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458261|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks||Baseline to 20 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458262|NCT00791258|Secondary|Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks||Baseline to 12 weeks|Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.|||Percentage of participants|||Number
1458263|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1458264|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1458265|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1458266|NCT00791258|Secondary|Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.|||Percentage of Participants|||Number
1458267|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
1458268|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.|||Percentage of Participants|||Number
1458269|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
1458270|NCT00791258|Secondary|Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2|||Percentage of Participants|||Number
1458385|NCT00790569|Secondary|Retention in Methadone Maintenance||12 months|Data not collected||||||
1459532|NCT00782756|Secondary|Neurocognitive Outcome||through study completion, an average of 1 year|37 participants agreed to undergo neuropsychological evaluations.|||Participants|||Count of Participants
1458271|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458272|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458273|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458274|NCT00791258|Secondary|Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458275|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1458276|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1458277|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1458278|NCT00791258|Secondary|Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.|||Percentage of Participants|||Number
1458279|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458280|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458281|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458282|NCT00791258|Secondary|Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458283|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458284|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458285|NCT00791258|Secondary|Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458286|NCT00791258|Secondary|Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458287|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458288|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458289|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458290|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458291|NCT00791258|Secondary|Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458292|NCT00791258|Secondary|Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||mm Hg||Standard Error|Mean
1458293|NCT00791258|Secondary|Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||mm Hg||Standard Error|Mean
1458294|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
1458295|NCT00791258|Secondary|Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
1458296|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
1458297|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
1458298|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.|Baseline to 20 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.|||Percentage of participants|||Number
1458299|NCT00791258|Secondary|Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks|Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM – 4PM.|Baseline to 12 weeks|Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.|||Percentage of participants|||Number
1458300|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458301|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458302|NCT00791258|Secondary|Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458303|NCT00791258|Secondary|Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of Participants|||Number
1458304|NCT00791258|Secondary|Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||Percentage of participants|||Number
1458305|NCT00791258|Secondary|Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||mm Hg||Standard Error|Mean
1458306|NCT00791258|Secondary|Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks||Baseline to 4, 8, 12, 16, 20 weeks|The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.|||mm Hg||Standard Error|Mean
1458307|NCT00791258|Secondary|The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks||Baseline to 12 and 20 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
1458308|NCT00791258|Secondary|The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
1458309|NCT00791258|Primary|The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks||baseline to 12 weeks|The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.|||Percentage of participants|||Number
1458310|NCT00791128|Secondary|HbA1c Values at 12 Months||12 months||||HbA1c (%)||Standard Deviation|Mean
1458311|NCT00791128|Primary|% of Excess Weight Loss (EWL)|"Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight~% EWL = (baseline excess weight - weight loss) x 100"|12 months||||% excess weight loss||Standard Deviation|Mean
1458312|NCT00791102|Secondary|Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment||15 minutes prior to treatment and 15 minutes post antigen challenges||||L/min||Inter-Quartile Range|Median
1458313|NCT00791102|Primary|Change in Itching Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
1458314|NCT00791102|Primary|Change in Stuffy Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
1458315|NCT00791102|Primary|Change in Runny Nose Symptom|The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||units on a scale||Inter-Quartile Range|Median
1459533|NCT00782756|Secondary|Progression Free Survival||through study completion, an average of 1 year||||months||Full Range|Median
1458316|NCT00791102|Secondary|Nasal Peak Inspiratory Flow Measurements|The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.|15 minutes after diluent challenge and 15 minutes after each antigen challenge||||L/min||Inter-Quartile Range|Median
1458317|NCT00791102|Primary|Change in Sneezing Symptom|Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.|10 minutes after diluent challenge and 10 minutes after each antigen challenge||||sneezes||Inter-Quartile Range|Median
1458318|NCT00791089|Primary|Number of Participants With Normal Sinus Rhythm (Freedom From Atrial Arrhythmias)|Freedom from atrial arrhythmias at 6 months will be defined as absence of any atrial arrhythmias with or without antiarrhythmic drug (AAD) therapy as shown in the two lines|6 months||||Participants|||Count of Participants
1458319|NCT00791076|Secondary|Frequency of Hypoglycemia Defined as < 60 mg/dl.||72 hours|The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Data, if collected,is unknown since no data are available.||||||
1458320|NCT00791076|Primary|Total Amount of Insulin Administered While on Placebo/PP.|Glucose values and the pattern of glycemic excursions over the 72 hour test period.|2 years|Data was not collected for this outcome measure. The P.I. left the institution and the study was terminated.||||||
1458321|NCT00791037|Secondary|Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)||Up to 2 years|Due to getting regulatory approvals we could only enroll 1 patient in this part of the protocol|||Participants|||Count of Participants
1458322|NCT00791037|Secondary|Development of CD4+ and CD8+ Epitope Spreading|As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens.|Up to 2 years||||Participants|||Count of Participants
1458323|NCT00791037|Secondary|Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT||Up to 2 year following the last infusion||||Participants|||Count of Participants
1458324|NCT00791037|Primary|Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0|Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur.|Up to 4 months after first booster vaccine|The infusion of escalating doses of HER2 specific T cells will be defined as safe if at least 75% of subjects are able to receive all 3 infusions without dose limiting toxicity (DLT)|||participants|||Number
1458325|NCT00790907|Secondary|Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population|||participants|||Number
1458326|NCT00790907|Secondary|Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.|Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30|ITT Population|||participants|||Number
1458327|NCT00790907|Secondary|Number of Participants With Major PCI-related Procedural Complications|Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.|During PCI procedure: immediately after randomization (approximately 10-75 minutes)|ITT Population|||participants|||Number
1458328|NCT00790907|Secondary|Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
1458329|NCT00790907|Secondary|Number of Participants With Minor Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
1458330|NCT00790907|Secondary|Number of Participants With Major Bleeding During the Peri-PCI Period|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|ITT Population|||participants|||Number
1460658|NCT00773474|Secondary|Toxicity Profile of Lonafarib|To determine the toxicity profile of lonafarnib in this patient population.|18 months||||participants|||Number
1458331|NCT00790907|Secondary|Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30|The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.|Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR|ITT Population|||participants|||Number
1458332|NCT00790907|Primary|Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period|The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.|Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)|Intent-to-Treat (ITT) Population: all randomized participants|||participants|||Number
1458333|NCT00790868|Secondary|Role Functioning|LIFE-RIFT. For this clinician-rated measure, total scores range from 0 to 20, with higher scores indicating greater impairment|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized sample|||units on a scale||Standard Deviation|Mean
1458334|NCT00790868|Secondary|Quality of Life Ratings|Quality of life as assessed by the Q-LES-Q. Scores range from 14-70 for total raw score, higher scores indicate higher quality of life ratings.|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized participants|||units on a scale||Standard Deviation|Mean
1458335|NCT00790868|Secondary|Depression Severity|Depression severity was assessed with the MADRS, with scores ranging from 0 to 60. Higher scores indicate greater depression.|Baseline, Tx Endpoint, Each of 4 follow-up assessments|Randomized participants with panic disorder|||units on a scale||Standard Deviation|Mean
1458336|NCT00790868|Primary|Remission Status|Remission status will be used as the primary categorical outcome variable. The CGI-S was used in determining whether patients met the “CGI-S of 1 or 2” component of the “remission status” criteria (i.e., zero panic attacks and CGI-S of 1 or 2 at endpoint). No values are missing because remission must be confirmed; missing status is assigned to disorder status. Hence results are for the full randomized sample.|Pre-treatment, Post-Treatment, and each follow-up sessions|Full sample of 180 randomized participants|||Participants|||Count of Participants
1458337|NCT00790868|Primary|Panic Disorder Severity Scale (PDSS)|The percent change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. The PDSS consists of seven items, each rated on a 0 to 4 scale (0 denoting none, and higher ratings reflecting greater degrees of symptom severity; for a possible range in scores from 0 to 28). In the tabular data below we present the total scores (sum of items).|baseline, mid-TX, post-TX, follow-up visits 1-4|Seventeen subjects out of 92 (five during treatment and 12 during follow-up, 20% total) in the control group compared to six out of 88 (four during treatment and two during follow-up, 10% total) in the DCS group dropped out.|||units on a scale||Standard Deviation|Mean
1458338|NCT00790855|Secondary|Number of Participants With a Response|A complete response (CR) is defined as normalization of the bone marrow and peripheral blood counts with </= 5% marrow blasts in a normo-or hypercellular marrow, with a granulocyte count of >/= 10^9/L and a platelet count of >/=100 X 10^9/L. A partial response (PR) was defined as for CR, but with only >/=50% reduction of marrow blasts and to a range of 6%-25%. A marrow complete response was defined as a reduction of marrow blasts to </=5% but without recovery of peripheral counts.|1 - 24 week cycles (up to 8 weeks)||||participants|||Number
1458339|NCT00790855|Primary|Maximum Tolerated Dose (MTD)|The MTD is the highest dose level in which <2 patients of 6 develop first cycle dose limiting toxicity (DLT). MTD assessed during course 1 (4 week cycle), every 3-7 days.|During course 1 (4 week cycle)||||mg/m^2|||Number
1458340|NCT00790803|Secondary|Change in Immunomodulatory Medications (Topical, Periocular or Systemic) After the Initiation of Macugen Therapy|No changes were to be made in immunodulatory medications of the patients unless needed for safety after in initiation of Macugen therapy.|32 weeks||||participants|||Number
1458341|NCT00790803|Secondary|A Decrease in Anterior Chamber Cells or Vitreous Cells or Haze in Injected Eye|"The degree of cell and flare was recorded at each visit during the course of the trial in the injected eye.~In uveitis, severely inflamed vessels leak protein which clouds the normally clear aqueous. This looks hazy with the slit lamp. If severe, it disperses the light beam, causing flare.~White or red blood cells may be observed: the presence of inflammatory cells in the anterior chamber suggests inflammation of the iris and ciliary body.~Blood cells: grading of blood cells in the anterior chamber is as follows:~0 - None.~1+ - faint (barely detectable).~2+ - moderate (clear iris and lens details).~3+ - moderate (hazy iris and lens details).~4+ - intense (fibrin deposits, coagulated aqueous)."|32 weeks||||participants|||Number
1458342|NCT00790803|Secondary|Decrease in CME as Evidenced by Imaging (Fluorescein Angiography and 50 Micron Change in OCT)|Patients retinal thickness was measured at each visit bu imaging to monitor increase or decrease in thickness.|32 weeks||||participants|||Number
1458343|NCT00790803|Secondary|Proportion of Patients Experiencing > 0 Letter Vision Gain and a < 15 Loss|Patients best corrected visual acuity was measured at each visit to monitor gain or loss of letters on the EDTRS chart.|32 weeks||||paticipants|||Number
1458344|NCT00790803|Primary|Improvement in VA ETDRS >/= 15 Letters|The primary outcome was an improvement in VA greater than or equal to fifteen letters on the EDTRS chart.|32 weeks|Five consecutive adult patients with non-infectious uveitis associated CME were chosen from the PI's regular medical clinic. Patients demonstrated, on fluorescein angiogram and/or optical tomography, bilateral or unilateral CME with non-infectious uveitis for greater than three months, but less than twelve.|||participants|||Number
1458386|NCT00790569|Secondary|Withdrawal Symptoms|Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
1458345|NCT00790790|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 30% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||Time (days)|||Number
1458346|NCT00790790|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (AEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
1458347|NCT00790790|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance was the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.|||Liter per hour (L/hr)||95% Confidence Interval|Geometric Mean
1458348|NCT00790790|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, followup questions rated the degree to which the issue impaired his/her ability to do work or read.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||participants|||Number
1458349|NCT00790790|Secondary|Number of Participants With Electrocardiogram (ECG) Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB ECG change >450 milliseconds (msec) was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||participants|||Number
1458350|NCT00790790|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1458351|NCT00790790|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1458352|NCT00790790|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
1458353|NCT00790790|Secondary|Number of Participants Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs) During the Therapy Phase and 1-Week Washout Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 147 participants randomized to study drug.|||participants|||Number
1458354|NCT00790790|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458355|NCT00790790|Secondary|Change From Baseline in European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EuroQoL Questionnaire - 5 Dimension (EQ-5D) was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458387|NCT00790569|Secondary|Change in Smoking Urges|Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
1458388|NCT00790569|Primary|CO-confirmed 7-day Abstinence|Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.|12 Months||||participants|||Number
1458356|NCT00790790|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicated better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458357|NCT00790790|Secondary|Change From Baseline in Total Western Ontario and MacMaster (WOMAC) Osteoarthritis Physical Function, Pain, and Stiffness Subscales at 5 Weeks|The Total WOMAC index (pain, stiffness, physical function subscales) was completed by the participant and had 24 questions. Each question was answered using a 5-point Likert scale (0 to 4). The Total score had a range from 0 (none) to 96 (extreme). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458358|NCT00790790|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represented better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458359|NCT00790790|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I was a scale that measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458360|NCT00790790|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S was a self-reported scale measuring severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessed worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 Weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458361|NCT00790790|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I was a self-reported scale measuring degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessed interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458362|NCT00790790|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458363|NCT00790790|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of night pain and worst pain each day, evaluated as weekly means.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.|||participants|||Number
1458364|NCT00790790|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458389|NCT00790569|Primary|Self-reported 7-day Abstinence|Number of participants with self-reported 7-day abstinence at 12-months|12 Months||||participants|||Number
1474759|NCT00670462|Secondary|Blood Glucose||baseline, 6, 12, 18, and 30 months|||||||
1458365|NCT00790790|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score From Electronic Diary at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1458366|NCT00790790|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score From Electronic Diary at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either LY545694 or placebo treatment with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.|||units on a scale||Standard Error|Least Squares Mean
1458367|NCT00790751|Primary|Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score|Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function.|Baseline, End of Treatment (up to 12 weeks)|Number of participants analyzed represents the Intent-to-Treat population. For dropouts or missing data, the last observation carried forward convention was used.|||scores on a scale||Standard Error|Least Squares Mean
1458368|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 Were you able to insert your penis into your partner's vagina?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
1458369|NCT00790751|Primary|Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse|"Data presented as mean change from baseline in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 Did your erection last long enough for you to have successful intercourse?"|Baseline, 12 weeks|Number of participants analyzed represents the Intent-to-Treat population.|||percentage of sexual attempts||Standard Error|Least Squares Mean
1458370|NCT00790738|Secondary|Clinical Global Impression Scores|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. At the time of rating patients are rated as: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|8 weeks||||units on a scale||Standard Deviation|Mean
1458371|NCT00790738|Secondary|Clinician-Administered Rating Scale for Mania|The Clinician-Administered Rating Scale for Mania (CARS-M) contains 15 items rated from 0-5 or 0-6 on a Likert scale. It was developed to assess severity of manic symtoms. The scale ranges from 0 to 50, and the following thresholds are used: severe ≥26, moderate 16-25, mild 8-15 and normal ≤7.|8 weeks||||units on a scale||Standard Deviation|Mean
1458372|NCT00790738|Primary|Hamilton Rating Scale for Depression Scores|The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms. The scale ranges from 0 to 50, and the following thresholds are used: very severe >23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.|8 weeks||||units on a scale||Standard Deviation|Mean
1458373|NCT00790673|Secondary|Evaluation of the Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell Adenosine 3 Receptor (A3R) Expression and Clinical Effects||16 weeks|||||||
1458374|NCT00790673|Primary|Pharmacokinetic Behavior of CF102 During Repeated Dosing||16 weeks|||||||
1458375|NCT00790673|Primary|Effect of Viral Load||16 weeks|||||||
1458376|NCT00790673|Primary|Adverse Event Profile of Repeated Dosing of CF102||16 weeks||||participants|||Number
1458377|NCT00790647|Secondary|Number of Participants Surviving at 2 Years||2 years from transplant||||Participants|||Count of Participants
1458378|NCT00790647|Secondary|Number of Participants Surviving at 1 Year||one year from transplant||||participants|||Number
1458379|NCT00790647|Secondary|Number of Participants Surviving at 100 Days From Transplant||100 Days from transplant date||||participants|||Number
1458380|NCT00790647|Primary|Number of Participants With Hematologic Response|"complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy <5% plasma cells with no clonal predominance of kappa or lambda isotype.~Partial response: any one of the following~For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells.~For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more.~For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume)."|one year||||participants|||Number
1458381|NCT00790569|Secondary|Change in Cigarettes Per Day|Change in mean cigarettes per day|6-Months||||cigarettes/day||Standard Deviation|Mean
1458382|NCT00790569|Secondary|Reinforcing Effects of Smoking|Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.|6 months||||units on a scale||Standard Deviation|Mean
1458383|NCT00790569|Secondary|Use of Illicit Drugs as Measured by Urine Toxicologies||12 months|Data not collected||||||
1458384|NCT00790569|Secondary|Methadone Dose Changes||12 months|Data not collected||||||
1458394|NCT00790556|Primary|Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14|Changes in HGP were determined during a euglycemic clamp procedure. HGP was evaluated as milligrams per kilogram of glucose produced per minute.|Day 14 of each 14-day Treatment Period|Subjects who discontinued were not used in the analysis.|||mg/kg/min||Standard Deviation|Mean
1458395|NCT00790556|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)|"An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body.~Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc.~Drug-relatedness was determined by the investigator based on clinical judgement."|56 days|All 14 subjects enrolled in the study were included in the assessment of safety and tolerability (although only 12 subjects received placebo, our database includes all subjects in the analysis).|||participants|||Number
1458396|NCT00790452|Primary|Frequency of VTE Events|Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.|VTE evaluation with study visits (4 weeks) for up to 2 years|Analysis was to be per protocol, study terminated early with no analysis. Only enrolled participant to the study was prematurely taken off the study due to a drug supply issue.|||participants|||Number
1458397|NCT00790400|Secondary|Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)|Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician’s global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by >=25% or more.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.|||months||95% Confidence Interval|Median
1458398|NCT00790400|Secondary|Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.|||months||95% Confidence Interval|Median
1458399|NCT00790400|Secondary|Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response|"Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume > 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.|||months||95% Confidence Interval|Median
1458400|NCT00790400|Secondary|Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose|C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be excluded from all analyses.|2 hours post-dose administration at Weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.|||ng/mL||Standard Deviation|Mean
1458401|NCT00790400|Secondary|Everolimus Trough Concentrations (Cmin)|Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.|Prior to dosing at weeks 2, 4, 12, 24, 48|The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.|||ng/mL||Standard Deviation|Mean
1458402|NCT00790400|Secondary|Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker|Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.|4 weeks, 12 weeks, 24 weeks, 36 weeks 48 weeks, 60 weeks, 72 weeks|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||pg/mL||Standard Deviation|Mean
1458417|NCT00790335|Secondary|Venous Clinical Severity Score|Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse|At 6 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458418|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 24 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458403|NCT00790400|Secondary|Percentage of Participants With Renal Impairment|Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of <30ml/min/1.73m2.|Day 1 up to 28 days after end of treatment|Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.|||Percentage of Participants|||Number
1458404|NCT00790400|Secondary|Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)|Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician’s Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
1458405|NCT00790400|Secondary|Time to Angiomyolipoma Progression as Per Central Radiology Review|"Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.~For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to about 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.|||months||95% Confidence Interval|Median
1458406|NCT00790400|Primary|Angiomyolipoma Response Rate as Per Central Radiology Review|"Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume > 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.~For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus."|From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years|The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.|||Percentage of Participants||95% Confidence Interval|Number
1458407|NCT00790335|Secondary|Change in Leg Circumference|Mean calf circumference measured 10 cm below the tibial tuberosity|Baseline to 30 days post-randomization|Modified full analysis set; intention to treat|||centimeters||Standard Error|Mean
1458408|NCT00790335|Secondary|Change in Leg Circumference|Mean calf circumference measured 10 cm below the tibial tuberosity|Baseline to 10 days post-randomization|Modified full analysis set; intention to treat|||centimeters||Standard Error|Mean
1458409|NCT00790335|Secondary|Change in Leg Pain Severity|Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain|Baseline to 30 days post-randomization|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458410|NCT00790335|Secondary|Change in Leg Pain Severity|Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain|Baseline to 10 days post-randomization|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458411|NCT00790335|Secondary|Change in Venous Disease-specific Quality of Life|Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.|Baseline to 24 months post-randomization|Modified full analysis set; intention to treat|||units on a scale||Standard Error|Mean
1458412|NCT00790335|Secondary|Change in General Quality of Life - Mental|Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.|Baseline to 24 months post-randomization||||units on a scale||Standard Error|Mean
1458413|NCT00790335|Secondary|Change in General Quality of Life - Physical|Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.|Baseline to 24 months post-randomization|Modified full analysis set; intention to treat|||units on a scale||Standard Error|Mean
1458414|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 24 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458415|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 18 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458416|NCT00790335|Secondary|Venous Clinical Severity Score|Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)|At 12 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1460659|NCT00773474|Secondary|Overall Response Rate|To determine overall response rate.|18 months|17 participants were evaluable for Overall Response Rate analysis using RECIST criteria.|||participants|||Number
1458419|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 18 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458420|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 12 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458421|NCT00790335|Secondary|Severity of Post-thrombotic Syndrome (Villalta)|Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.|At 6 months|Modified full analysis set; intention to treat|||points||Standard Error|Mean
1458422|NCT00790335|Secondary|Death|All-cause mortality|Within 24 months after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1458423|NCT00790335|Secondary|Death|All-cause mortality|Within 10 days after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1458424|NCT00790335|Secondary|Recurrent Venous Thromboembolism|Symptomatic recurrent venous thromboembolism (DVT and/or PE)|Within 24 months after randomization|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1458425|NCT00790335|Secondary|Recurrent Venous Thromboembolism|Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)|Within 10 days after randomization||||Participants|||Count of Participants
1458426|NCT00790335|Secondary|Any (Major + Minor) Bleeding|Clinically overt bleeding that occurred within 24 months post-randomization|Within 24 months after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
1458427|NCT00790335|Secondary|Any (Minor + Major) Bleeding|Clinically overt bleeding that occurred through 10 days post-randomization|Within 10 days after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
1458428|NCT00790335|Secondary|Major Bleeding|Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).|Within 24 months after randomization|Modified full analysis set; intention-to-treat|||Participants|||Count of Participants
1458429|NCT00790335|Secondary|Major Bleeding|Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).|Within 10 days after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
1458430|NCT00790335|Secondary|Moderate-to-severe Post-thrombotic Syndrome|Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.|Between 6 and 24 months after randomization|Modified full analysis set, intention-to-treat|||Participants|||Count of Participants
1458431|NCT00790335|Secondary|Any Treatment Failure|Composite of PTS and major non-PTS treatment failure|Through 24 months|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1458432|NCT00790335|Secondary|Major Non-post-thrombotic Syndrome Treatment Failure|A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.|Through 24 months|Modified full analysis set; intention to treat|||Participants|||Count of Participants
1458433|NCT00790335|Primary|Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)|Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.|Between 6 and 24 months after randomization|Modified full analysis set; intention-to-treat|||Participants|||Count of Participants
1458434|NCT00790296|Primary|Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion|1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.|Baseline and 7 hours post study medication infusion||||Scores on a scale||Standard Deviation|Mean
1458435|NCT00790270|Secondary|Resumption of Work or School|number of patients resuming regular activity the day following enrollment.|next day||||participants|||Number
1458436|NCT00790270|Primary|Use of Rescue Medications|the number of patients taking additional rescue medications beyond the study meds|24 hours|number of patients using additionl anlagesics on the day following enrollment|||participants|||Number
1458437|NCT00790270|Secondary|Time to Resumption of Work||1 week|||||||
1458438|NCT00790270|Primary|Pain||Daily for 1 week|||||||
1458439|NCT00790218|Primary|Maximum Tolarated Dose|The MTD was defined as the highest dose level at which < 2 of 6 patients developed Cycle 1 DLT.|first 28 days (Cycle 1)|||||||
1458440|NCT00790218|Secondary|Relationship Between Biomarkers of Peripheral Blood Mononuclear Cell (PBMC) Adenosine A3 Receptor (A3AR) Expression and Clinical Effects of CF102||Baseline|||||||
1458441|NCT00790218|Secondary|Therapeutic Effect of CF102 in Hepatocellular Carcinoma||Every 2 months|||||||
1458442|NCT00790218|Primary|Repeat-dose Pharmacokinetic Behavior of CF102||1 month|||||||
1458443|NCT00790218|Primary|Dose Limiting Toxicity|Dose-limiting toxicity was defined as a clinically significant AE or laboratory abnormality occurring in Cycle 1|From start of treatment until Day 28 of Cycle 1||||participants|||Number
1458444|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1464640|NCT00744380|Secondary|Cumulative Doses of Conventional Sedatives and Analgesics||Duration of ICU stay, for up to 24 weeks||||mg||Inter-Quartile Range|Median
1458445|NCT00790205|Secondary|Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)|In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.)|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1458446|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1458447|NCT00790205|Secondary|Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)|Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1458448|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value for the outcome measure.|||g/mol Creatinine||Standard Deviation|Mean
1458449|NCT00790205|Secondary|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)|Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||g/mol Creatinine||Standard Deviation|Mean
1458450|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Intent to Treat Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants in the intent to treat population with a baseline value.|||Percentage of HbA1c||Standard Deviation|Mean
1458451|NCT00790205|Secondary|Change From Baseline in HbA1c Over Time (Per Protocol Population)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region.|Baseline and up to 4 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||Percentage of HbA1c||Standard Deviation|Mean
1458452|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Intent to Treat Population)|Change in renal function based on eGFR using the MDRD method.|Baseline and up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation. Number of participants analyzed consists of those participants with a baseline value.|||mL/min/1.73 m^2||Standard Deviation|Mean
1458453|NCT00790205|Secondary|Change From Baseline in Renal Function Over Time (Per Protocol Population)|Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.|Baseline and up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data. Number of participants analyzed consists of those participants with a baseline value.|||mL/min/1.73 m^2||Standard Deviation|Mean
1458454|NCT00790205|Secondary|Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1458455|NCT00790205|Secondary|Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)|Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1458456|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Intent to Treat Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1458457|NCT00790205|Secondary|Percent Incidence of All-cause Mortality (Per Protocol Population)|Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1459534|NCT00782756|Primary|Number of Participants With Adverse Events|Safety assessments and toxicity grading will follow CTCAE Version 4 Grade|through study completion, an average of 1 year||||Participants|||Count of Participants
1458458|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1458459|NCT00790205|Secondary|Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)|CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1458460|NCT00790205|Primary|Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Intent to treat population included all randomized participants who received study medication, provided consent, and did not have a major GCP deviation.|||Percentage of participants|||Number
1458461|NCT00790205|Primary|Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)|Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.|Up to 5 years|Per protocol population included all randomized participants who received study medication except those participants who did not contribute at least 1 day of data to the study analysis due to a major protocol violation that excluded all of their data.|||Percentage of participants|||Number
1458462|NCT00790192|Secondary|Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment|Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 (‘normal’, not ill) to 7 (extremely ill).|6-Weeks||||scores on a scale||95% Confidence Interval|Least Squares Mean
1458463|NCT00790192|Primary|Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase|The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Week 6|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||scores on a scale||95% Confidence Interval|Least Squares Mean
1458464|NCT00790062|Primary|Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors|The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia.|baseline to discharge (2-3 days)||||participants|||Number
1458465|NCT00790062|Secondary|Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus|number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure)|Initial hospital discharge (2-3 days or more)||||Participants|||Number
1458466|NCT00790062|Secondary|Number of Subjects With Hospital Stays Greater Than 4 Days|Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge|Initial hospital discharge (2 days or more)||||Participants|||Number
1458467|NCT00790062|Secondary|Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc)|the number of individuals with a clinically estimated postpartum blood loss of 500cc or more|Initial hospital discharge (2-3 days)||||Participants|||Number
1458468|NCT00790062|Secondary|Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome|the number of individuals with each of the component treatments or individual outcomes in the primary composite.|prior to discharge||||Participants|||Number
1458469|NCT00790062|Secondary|Change in Pre- to Post-delivery Hematocrit (%)|change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery)|During delivery hospitalization: Admission hematocrit - post-delivery hematocrit||||hematocrit difference (%)||Inter-Quartile Range|Median
1458470|NCT00790062|Primary|Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage|In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus.|Initial hospital discharge (2-3 days)||||participants|||Number
1458471|NCT00790062|Primary|Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment|the number of subjects with any treatment of uterineatony or hemorrhage.|baseline to discharge (2 - 3 days)||||Participants|||Number
1458472|NCT00790036|Secondary|Lymphoma-specific Survival (LSS)|LSS was defined as time from randomization to death as a result of lymphoma.|From randomization to death documented as a result of lymphoma up to 7 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1458473|NCT00790036|Secondary|Overall Survival (OS)|OS was defined as the time from date of randomization to date of death due to any cause. If the patient was not known to have died, survival was censored at the date of the last contact.|From date of randomization to date of death due to any cause up to around 7 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1458544|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1458474|NCT00790036|Primary|Disease-free Survival (DFS)|DFS was defined as the time from date of randomization to the date of event defined as the first documented relapse of the disease or death due to any cause. Relapse was based on investigator assessment and was assigned only if: It was documented according to Cheson guidelines by an objective radiological assessment method; It was documented by a biopsy proven lymphoma including new or recurrent bone marrow involvement; A new anticancer therapy for lymphoma started with subsequent confirmation of the relapse within 4 weeks of the start of this anticancer therapy|From date of randomization to the date of event defined as the first documented recurrence of the disease, or death due to any cause and up to 6 years|Full Analysis Set (FAS) includes all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
1458475|NCT00790023|Secondary|Time to Maximal Effect as Measured by Change From Baseline in the Average AM and PM Reflective Total Nasal Symptoms Scores (rTNSS)|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between Ciclesonide HFA and placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day.|Week 0-2|Intent to Treat Population|||days||Standard Error|Least Squares Mean
1458476|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Ocular Symptoms Scores (iTOSS) in Subjects With Baseline iTOSS ≥5.0|"Onset of improvement iTOSS was defined as the first assessment at which iTOSSS for active treatment demonstrated an improvement over placebo from baseline. TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval."|Baseline and up to 48 hours|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458477|NCT00790023|Secondary|Onset of Improvement in Instantaneous Total Nasal Symptoms Scores (iTNSS)|"Onset of nasal improvement was defined as the first assessment at which iTNSS for active treatment demonstrated an improvement over placebo from baseline.~TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and 12 reflecting more severe symptoms). Instaneous measures these symptoms over the previous 10 minute time interval."|Baseline and up to 36 hours|Intent to Treat Population. Some participants excluded for missing data.|||Units on a scale||Standard Error|Least Squares Mean
1458478|NCT00790023|Secondary|Change From Baseline in Overall Score of the Rhinoconjunctivitis Quality of Life Questionnaire With Standard Activities (RQLQ(S)) in Participants With a Baseline Overall Score >= 3.0|The RQLQ(S) in impaired subjects (baseline RQLQ[S] score ≥3.0) at baseline and end of week 2. It consists of 28 questions, each question measured on a scale of 0-6 where a higher score indicates poor quality of life. Domains: Activities (questions 1-3), Sleep (questions 4-6), Non-Nose/Eye Symptoms (questions 7-13), Practical Problems (questions 14-16), Nasal Symptoms (questions 17-20), Eye Symptoms (questions 21-24), and Emotional (questions 25-28). The overall RQLQ(S) score was calculated as the average of the mean domain scores.|Week 0-2|In participants with a Baseline overall score >= 3.0|||units on a scale||Standard Error|Least Squares Mean
1458479|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458480|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458481|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Instantaneous OSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458482|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported and AM and PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458545|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8|Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1458483|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458484|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"OSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and 9 reflecting more severe symptoms). Reflective OSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458485|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458486|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458487|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458488|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458489|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458490|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rNSS Averaged Over the Two Week Treatment Period|"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458491|NCT00790023|Secondary|Change From Baseline in Daily Subject Reported AM and PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458522|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 weeks of treatment||||Participants|||Number
1458492|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458493|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline iTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline iTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458494|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458495|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTOSS Averaged Over the Two Week Treatment Period in Subjects With Baseline rTOSS ≥5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|In Subjects With Baseline rTOSS ≥5.0|||Units on a scale||Standard Error|Least Squares Mean
1458496|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458497|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM iTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458498|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported PM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458499|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM rTNSS Averaged Over the Two Week Treatment Period|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2||||Units on a scale||Standard Error|Least Squares Mean
1458500|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM rTOSS Averaged Over the Two-week Treatment Period in Participants With a Baseline rTOSS >= 5.0|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as week two treatment average – baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population. In participants with a baseline rTOSS >= 5.0|||units on a scale||Standard Error|Least Squares Mean
1458543|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 week of treatments||||Participants|||Number
1458501|NCT00790023|Secondary|Change From Baseline in Daily Subject-reported AM and PM iTNSS Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
1458502|NCT00790023|Primary|Change From Baseline in Daily Subject-reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Averaged Over the Two-week Treatment Period.|"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Week 0-2|Intent to treat population.|||units on a scale||Standard Error|Least Squares Mean
1458503|NCT00789997|Secondary|Number of Participants With Treatment Failure by 90 Days Assignment|In the etanercept group 16/40 (40%) failed treatment compared with 12/38 (32%) in the prednisone group.|Day 0 to Day 90||||participants|||Number
1458504|NCT00789997|Primary|Change in Lung Function (Forced Expiratory Volume in 1 Second (FEV1)|"FEV1 was obtained using calibrated spirometers at approximately the same time of day at all visits throughout the study. The highest acceptable FEV1 and the highest FVC measurement each obtained on any of three blows (even if not from the same curve) meeting the American Thoracic Society criteria constituted the data for that test set.~Not all participants had Day 14 FEV1 measures collected"|Day 0 to Day 14||||percentage of change in FEV1||Standard Error|Mean
1458505|NCT00789958|Secondary|2-year Overall Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1458506|NCT00789958|Secondary|2-year Stratum-specific Local Relapse Rate|Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1458507|NCT00789958|Secondary|2-year Disease-free Survival in All Patients|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1458508|NCT00789958|Secondary|2-year Stratum-specific Disease-free Survival|Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1458509|NCT00789958|Secondary|2-year Overall Survival for All Patients|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1458510|NCT00789958|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
1458511|NCT00789958|Primary|Stratum-specific (R0 and R1) 2-year Overall Survival|Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients that received protocol treatment.|||percentage of participants||95% Confidence Interval|Number
1458512|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458513|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458847|NCT00787267|Secondary|Overall Survival|Overall survival (OS) is the duration from date of consent to date of death from any cause.|Progression and survival every 6 months|All subjects who received at least one dose of dasatinib were included in the analysis.|||months||95% Confidence Interval|Median
1458514|NCT00789880|Secondary|Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458515|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458516|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458517|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458518|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458519|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458520|NCT00789880|Primary|Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo|Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.|Baseline to Day 21||||Cycle Number||Standard Deviation|Mean
1458521|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm.|6 week of treatments||||Participants|||Number
1458523|NCT00789854|Secondary|Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients|The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a ‘marked/moderate’ therapeutic effect and ‘None/Do Not Significantly Interfere’ side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221).|6 weeks of treatment||||Participants|||Number
1458524|NCT00789854|Secondary|Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)|Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1458525|NCT00789854|Secondary|Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility|Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1458526|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component|Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1458527|NCT00789854|Secondary|Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component|Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1458528|NCT00789854|Secondary|Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)|Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1458529|NCT00789854|Secondary|Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4|Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement)|6 weeks of treatment||||MADRS item 4 score||Standard Error|Least Squares Mean
1458530|NCT00789854|Secondary|Change in Anxiety Measured by STAI, Trait Anxiety Inventory|Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1458531|NCT00789854|Secondary|Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory|Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement)|6 weeks of treatment||||Scores on a scale||Standard Error|Least Squares Mean
1458532|NCT00789854|Secondary|Change in Anxiety Measured by Visual Analog Scale (VAS)|Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1458533|NCT00789854|Secondary|Change in Pain, Measured by Visual Analog Scale (VAS)|Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1458534|NCT00789854|Secondary|Change in Beck Depression Inventory (BDI)|Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1458535|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1458536|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1458537|NCT00789854|Secondary|Change in Clinical Global Impression Scale (CGI-S), All Patients|Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1458538|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
1458539|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
1458540|NCT00789854|Secondary|Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients|Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement.|6 weeks of treatment||||scores on a scale||Standard Deviation|Mean
1458541|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment||||Participants|||Number
1458542|NCT00789854|Secondary|Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure|Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better|6 weeks of treatment||||Participants|||Number
1461767|NCT00765388|Primary|Preference of Sensura vs Moderma|Subjects were asked which of the tested products they preferred; SenSura or Moderma.|4 weeks||||percentage of prefering the product|||Number
1458546|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure|Number of patients in remission with two previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1458547|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure|Number of patients in remission with one previous treatment failure and with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1458548|NCT00789854|Secondary|Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients|Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status.|6 weeks of treatment||||Participants|||Number
1458549|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks of treatment||||scores on a scale||Standard Error|Least Squares Mean
1458550|NCT00789854|Primary|Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)|Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.|6 weeks treatment|Analysis was 'per protocol'. Exclusion reason from analysis: Violation of exclusion/inclusion criteria; Non-compliance regarding prohibited concomitant medication, Total unavailability of MADRS score after randomization, Patient not treated with any dose of study drug after randomization, Non-compliance regarding titration to 300 mg quetiapine/d.|||scores on a scale||Standard Error|Least Squares Mean
1458551|NCT00789828|Secondary|Percentage of Participants With Renal Impairment During Core Period|Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788*(serum creatinine (micromol/L)^-1.154)*(age^-0.203 )*(0.742, if female)*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR < 30 mL/min/1.73 m^2 and participants with National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.|Day 1 up to 28 days after end of treatment (Core period)|"The analysis was performed in the SAF population. Here, Number of participants analysed signifies the participants assessed for renal function during the study for each arm, respectively."|||Percentage of participants|||Number
1458552|NCT00789828|Secondary|Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose|The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as <5 ng/mL, 5-10 ng/mL, and >10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ng/mL||Standard Deviation|Mean
1458553|NCT00789828|Secondary|Everolimus Blood Concentration (C2h) at 2 Hours Post Dose|The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as < 20 ng/mL, 20-50 ng/mL, and > 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.|2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240|The analysis was performed in the Safety Set population (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ng/mL||Standard Deviation|Mean
1458554|NCT00789828|Secondary|Duration of Skin Lesion Response in Everolimus Treated Participants|Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by > 25% or more from baseline.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population. Here, “Number of participants analysed” signifies everolimus treated responders with best overall skin lesion response during the core and extension period, respectively.|||months||95% Confidence Interval|Median
1458555|NCT00789828|Secondary|Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score|Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician’s Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but < 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - < 50% and 6 = progressive disease, indicated worse than at baseline evaluation by > 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response.|End of core period (Week 48), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for skin lesion response during the study for each arm, respectively."|||Percentage of participants||95% Confidence Interval|Number
1458605|NCT00789737|Secondary|Changes in High Density Lipoprotein Cholesterol [HDL-C]|To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||md/dL||Standard Error|Least Squares Mean
1458556|NCT00789828|Secondary|Time to SEGA Worsening|Time to SEGA worsening was defined as the time from the start of everolimus to date of the first SEGA worsening. SEGA worsening was defined as either; increase from nadir of ≥ 25% in SEGA volume or unequivocal worsening of non-target SEGA lesions, or appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, or new or worsening hydrocephalus. The median value was not reached in either treatment arm of core period as SEGA worsening was observed in less participants (everolimus - 7 and placebo - 8).|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for time to SEGA worsening during the study for each arm, respectively."|||months||95% Confidence Interval|Median
1458557|NCT00789828|Secondary|Duration of SEGA Response|Duration of SEGA response was defined as time from the date of the first documented SEGA response until the date of the first documented SEGA progression. Duration of SEGA response was evaluated only for participants who achieved a SEGA response. The time to SEGA progression was censored if SEGA progression was not observed before the first to occur out of (i) analysis cut-off date (ii) the date when systemic anti-SEGA medication is started, (iii) the date of a SEGA-related surgery or (iv) the date of death. Since, no case of SEGA progression was observed in core study which resulted in censored duration of SEGA response. Only 5 SEGA responders experienced a SEGA progression in extension period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here, Number of participants analysed signifies the participants assessed for SEGA progression during the study for each arm, respectively."|||months||95% Confidence Interval|Median
1458558|NCT00789828|Secondary|Time to SEGA Response|Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|The analysis was performed in the FAS population.|||months||95% Confidence Interval|Median
1458559|NCT00789828|Secondary|Time to SEGA Progression|Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.|Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)|"The analysis was performed in the FAS population. Here Number of participants analysed signifies the participants assessed for time to SEGA progression during the study for each arm, respectively."|||months||95% Confidence Interval|Median
1458560|NCT00789828|Secondary|Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period|Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was < 18 hours.|Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)|The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.|||Seizure frequency||Standard Deviation|Mean
1458561|NCT00789828|Primary|Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response|Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.|End of core period (Week 48), and end of extension period (up to 4 years)|The primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.|||Percentage of participants||95% Confidence Interval|Number
1458562|NCT00789815|Secondary|Patients Willing Return if Repeated Bronchoscopy is Indicated.|"Patients were asked their willingness to return for another FB if needed by means of a five-point scale (definitely not, probably not, unsure, probably would, and definitely would return). Both probably would, and definitely would return were defined as patients agreed to return."|After patients recovered orientation and before they leaved the scope room.|Patients who answered the question in the questionnaire after bronchoscopy|||participants|||Number
1458563|NCT00789815|Secondary|The Recovery Time to Ambulation|The recovery time to ambulation defined as the time between finishing flexible bronchoscopy to the moment when patients could walk without assistance.|After the bronchoscopy||||Minutes||Standard Deviation|Mean
1458564|NCT00789815|Primary|The Global Tolerance for Flexible Bronchoscopy by Verbal Analogus Scale|The global tolerance of the entire procedure was evaluated on a 10-point verbal analogous scale (VAS, 0: no bother, 10: worst intolerable).|After patients recovered orientation and before they leaved the scope room.|Patients received intervention completely|||units on a scale||Full Range|Median
1458565|NCT00789815|Secondary|The Recovery Time to Orientation|The time to orientation defined as the time between finishing flexible bronchoscopy to the moment when patients could open their eyes spontaneously, could recall their date of birth, and perform a finger-nose test correctly|After the bronchoscope leaving patients' nose or mouth to the time patients returned orientation||||minutes||Standard Deviation|Mean
1458566|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by Cough|“Procedure interference by cough” was when the bronchoscopist had to stop the procedure temporarily and additional xylocaine spray and/or alfentanil had to be given to stop the cough.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth||||participants|||Number
1458567|NCT00789815|Secondary|The Number of Participants Causing Any Procedure Interference by the Patients' Movement During Flexible Bronchoscocopy|“Procedure interference by patients’ movement” was when the bronchoscopist had to stop the procedure temporarily and our assistant had to hold down the irritant patient|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth||||participants|||Number
1458568|NCT00789815|Primary|The Number of Participants With Any Hypotension Event During Flexible Bronchoscopy|The event of hypotension: when the systolic blood pressure (SBP) was less than 90mmHg with any duration.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|patients completed the whole intervention|||participants|||Number
1458569|NCT00789815|Primary|The Number of Participants With Any Hypoxemia Event During Flexible Bronchoscopy|The hypoxemia event is defined as that when the oxyhemoglobin (SpO2) was less than 90% with any duration during the flexible bronchoscopy.|From the time when bronchoscope introducing patients' nose or mouth to the time when bronchoscope leaving patients' nose or mouth|Patients completed the whole intervention.|||participants|||Number
1458570|NCT00789802|Secondary|Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups|To compare continuation rates of the LNG-IUC at the end of the 12 week between the 3 study groups|12 weeks||||Participants|||Count of Participants
1458571|NCT00789802|Secondary|Patient Satisfaction With the LNG-IUC at the End of the 12 Weeks Between the 3 Study Groups.|To compare the level of patient satisfaction with the LNG-IUC at the end of the 12 weeks between the 3 study groups.|12 weeks|There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.|||Participants|||Count of Participants
1458572|NCT00789802|Secondary|Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.|Median number of bleeding days observed in women with a LNG-IUC treated with naproxen, estradiol and placebo at 16 weeks.|16 weeks|There 129 women who were randomly assigned to the 3 arms. At 12 weeks of follow up, there were 17 participants lost to follow up. This resulted in a total analysis population of 112 participants.|||days||Full Range|Median
1458573|NCT00789802|Primary|Number of Bleeding and Spotting Days|The median number of bleeding and spotting days reported at 12 weeks.|12 weeks||||DAYS||Full Range|Median
1458574|NCT00789776|Secondary|Number of Participants Who Experienced Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.|Up to 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1458575|NCT00789776|Secondary|Number of Subjects Surviving Post-transplant.|Number of subjects surviving post-transplant.|Up to 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1458576|NCT00789776|Primary|Number of Participants Who Experienced Graft Failure|Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts >2 weeks and is refractory to growth factor support.|Day 100|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1458577|NCT00789776|Primary|Number of Non-relapse Participant Mortalities|Defined as death in any patient for whom there has not been a diagnosis of relapse or disease progression.|Day 200|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1458578|NCT00789776|Primary|Number of Participants With Grades III-IV Acute GVHD|"Number of patients who developed acute GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death"|Day 100|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1458579|NCT00789776|Primary|Number of Participants With Relapsed Disease|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|At 1 year|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1474760|NCT00670462|Secondary|Waist-to-hip Ratio at Baseline||baseline||||ratio||Standard Error|Mean
1458580|NCT00789776|Primary|Number of Participants With Dose Limiting Toxicities|Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality.|Day 35 (28 days after NK cell infusion)|One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
1458581|NCT00789750|Secondary|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR is a calculation of fasting insulin and fasting glucose that shows the level of insulin resistance. Lower numbers are better.|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||calculation||Standard Error|Least Squares Mean
1458582|NCT00789750|Secondary|Change From Baseline in Fasting C-peptide||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||ng/mL||Standard Error|Least Squares Mean
1458583|NCT00789750|Secondary|Change From Baseline in Fasting Insulin Levels||Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||µIU/mL||Standard Error|Least Squares Mean
1458584|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apo B is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1458585|NCT00789750|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)|Apo A-1 is measured in mg/dL|Baseline, Week 24|Intent-to-treat, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1458586|NCT00789750|Secondary|Percent Change From Baseline in Triglycerides (TG)|TG are measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Inter-Quartile Range|Median
1458587|NCT00789750|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1458588|NCT00789750|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|HDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1458589|NCT00789750|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|LDL-C is measured in mg/dL|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last count carried forward|||percentage of change||Standard Error|Least Squares Mean
1458590|NCT00789750|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|TC is measured in milligrams per deciliter (mg/dL)|Baseline, Week 24|Intent-to-treat set, with values at both baseline and Week 24 with last observation carried forward|||percentage of change||Standard Error|Least Squares Mean
1458591|NCT00789750|Secondary|Number of Participants With a Reduction in FPG of >= 30 mg/dL||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
1458592|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.5 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
1458593|NCT00789750|Secondary|Number of Participants With a Decrease of >= 0.7 Percent in HbA1c||Week 24|Intent-to-treat set, with last count carried forward|||Participants|||Count of Participants
1458594|NCT00789750|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|In this study a reduction in FPG of at least 30 mg/dL is considered glycemic response.|Baseline, Week 24|Participants in the intent-to-treat set with values at both baseline and Week 24 with last observation carried forward|||mg/dL||Standard Error|Least Squares Mean
1458595|NCT00789750|Secondary|Number of Participants Achieving an HbA1c Goal of <7.0%||Week 24|Intent-to-treat set, with last observation carried forward|||Participants|||Count of Participants
1458596|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 16||Baseline, Week 16|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
1458597|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 8||Baseline, Week 8|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
1458598|NCT00789750|Secondary|Change From Baseline in HbA1c at Week 4||Baseline, Week 4|Intent to treat set, with baseline and post-baseline measures at the given time point|||percent||Standard Error|Least Squares Mean
1458599|NCT00789750|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24||Baseline, Week 24|Intent-to-treat, last observation carried forward|||percent||Standard Error|Least Squares Mean
1458600|NCT00789737|Secondary|Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test|To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458601|NCT00789737|Secondary|Changes in Apolipoprotein B (apoB)|To assess the effects of Welchol on changes in apolipoprotein B (apoB)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458602|NCT00789737|Secondary|Changes in Apolipoprotein A-I (apoA-I)|To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458603|NCT00789737|Secondary|Changes in Triglycerides [TG]|To assess the effects of Welchol on changes in triglycerides [TG]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458604|NCT00789737|Secondary|Changes in Non-HDL-C|To assess the effects of Welchol on changes in non-HDL-C|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458606|NCT00789737|Secondary|Changes in Low Density Lipoprotein Cholesterol [LDL-C]|To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458607|NCT00789737|Secondary|Changes in Total Cholesterol [TC]|To assess the effects of Welchol on changes in total cholesterol [TC]|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458608|NCT00789737|Secondary|% Subjects With a Decrease in FPG >=30 mg/dL|% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
1458609|NCT00789737|Secondary|% Subjects Achieving an HbA1C Goal of <7.0|% Subjects achieving an HbA1C goal of <7.0 at 24 weeks|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
1458610|NCT00789737|Secondary|% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units|to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.|24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage of participants|||Number
1458611|NCT00789737|Secondary|Change in Fasting Plasma Glucose|to determine changes in Glycemic control after 24 weeks on therapy|from baseline to 24 weeks|Some participants may not have had lab results for this specific analysis and therefore excluded.|||mg/dL||Standard Error|Least Squares Mean
1458612|NCT00789737|Primary|Percent Change in Hemoglobin A1c|change in HbA1c from baseline to Week 24|24 week|Intent to Treat, Last Observation Carried Forward (LOCF) Some participants may not have had lab results for this specific analysis and therefore excluded.|||percentage change of hemoglobin A1c||Standard Error|Mean
1458613|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in End-diastolic Volume Indices and Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging||10-14 weeks|||||||
1458614|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in E/E' Ratios and Myocardial Performance (Tei) Indices From Baseline to Follow up Exam at Transthoracic Echo-color-Doppler Cardiac Exam||10-14 weeks|||||||
1458615|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in Oxygen Uptake Kinetics From Baseline to Follow up Exam at Submaximal Cardiopulmonary Exercise Test||10-14 weeks|||||||
1458616|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Number of Adverse Effects Including a) All Events; b) All Events Requiring Unblinding of the Treatment; c) All Events Requiring Early Termination of the Intervention||10-14 weeks|||||||
1458617|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Incidence of Significant Cardiac Arrhythmias in the Acute Phase||48 hours|||||||
1458618|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in Serum BNP Levels, C-reactive Protein, and Hemoglobin A1c% From Baseline to Follow up||10-14 weeks|||||||
1458619|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in Change in the Number of Circulating Endothelial Progenitor Cells From Baseline to Follow up Exam||10-14 weeks|||||||
1458620|NCT00789724|Other Pre-specified|Difference Between the 2 Arms in the Percentage of Patients With Any of the Following : a) End-systolic or End-diastolic Volume Index Increase >10%; b) Ejection Fraction Decrease >10%; c) E/E'>15 at Follow up||10-14 weeks|||||||
1458621|NCT00789724|Primary|Difference Between the Anakinra Arm and Placebo Arm in Change in End-systolic Volume Indices From Baseline to Follow up Exam 10-14 Weeks Later at Cardiac Magnetic Resonance Imaging.||10-14 weeks||||mL/m2||Inter-Quartile Range|Median
1458622|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores|The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity.|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
1458623|NCT00789698|Secondary|Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)|The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis).|Baseline and 12 months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
1458624|NCT00789698|Secondary|Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.|The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6.|Baseline and 6 Months|The population is the intent to treat population which consists of those enrolled subjects who receive at least one dose of study medication and have either a PANSS or CGI-S baseline and post baseline measurements|||units on a scale||95% Confidence Interval|Least Squares Mean
1458640|NCT00789672|Primary|Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.|9 weeks after starting levodopa||||letters||Standard Deviation|Mean
1458934|NCT00787020|Primary|Cerebral Artery Vasospasm|Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.|14 days||||Participants|||Number
1458625|NCT00789698|Primary|Relapse of Psychotic Symptoms|"Time to relapse will be defined as the earliest occurrence of any of the following:~Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3~rehospitalization for worsening of psychosis~emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate."|12 Months|The population for relapse analyses is the relapse population which consists of those subjects who are enrolled in the present study, demonstrated response to 6 weeks of treatment with either lurasidone or quetiapine XR in study D1050233-NCT 00790192, and who took at least one dose of study medication in the present study.|||participants|||Number
1458626|NCT00789685|Secondary|All Cause Mortality Rate at 6 Months|A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment|6 months following commencement of therapy|Number of patients whose survival status at 6 months was known|||percentage of patients who died|||Number
1458627|NCT00789685|Primary|All Cause Mortality at Day 28|The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment|28 days following commencement of therapy|Patients included in Safety population|||percentage of patients who died|||Number
1458628|NCT00789685|Primary|Clinically Significant Treatment Emergent Events|Treatment-emergent adverse events (TEAEs) in safety population|From first dose up until Day 28|Patients included in Safety population|||Number of patients|||Number
1458629|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa||||letters||Standard Deviation|Mean
1458630|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 10 weeks after stopping levodopa||||participants|||Number
1458631|NCT00789672|Secondary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks||||letters||Standard Deviation|Mean
1458632|NCT00789672|Secondary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|enrollment to 4 weeks||||participants|||Number
1458633|NCT00789672|Primary|Tolerability of Study Medication-Adverse Event Reporting|Number of adverse events reported throughout entire study.|24 weeks||||events|||Number
1458634|NCT00789672|Primary|Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks||||letters||Standard Deviation|Mean
1458635|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|10 weeks after stopping levodopa||||letters||Standard Deviation|Mean
1458636|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|10 weeks after stopping levodopa||||participants|||Number
1458637|NCT00789672|Secondary|Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.|4 weeks after enrollment||||letters||Standard Deviation|Mean
1458638|NCT00789672|Secondary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|4 weeks after enrollment||||participants|||Number
1458639|NCT00789672|Primary|Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.|baseline to 9 weeks||||participants|||Number
1458687|NCT00789074|Secondary|Change in Pre-quit Cigarette Consumption|Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.|Baseline - week 4|All participants that provided data at each session|||Cigarettes consumed per day||Standard Deviation|Mean
1458641|NCT00789672|Primary|Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa|Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).|9 weeks after starting levodopa||||participants|||Number
1458642|NCT00789581|Secondary|Overall Survival|The percentage of participants with overall survival at 3 and 5 years are presented. Overall survival (OS) defined as the time between randomization to date of death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1458643|NCT00789581|Primary|Disease-free Survival|The percentage of participants with disease-free survival at 3 and 5 years. Disease-free survival (DFS) is measured from the time between randomization and the date of first documented disease recurrence, or death from any cause.|up to 5.25 years (63 months)|The intent-to-treat population (all randomized patients) are included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1458644|NCT00789555|Primary|Self-Rated Relief Assessment at Day 30|"Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief."|Day 30|Analysis population included all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT). The LOCF (last observation carried forward method) was used to impute missing data.|||Units on a scale||Standard Deviation|Mean
1458645|NCT00789555|Secondary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1458646|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1458647|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1458648|NCT00789555|Secondary|Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner)|Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes.|Baseline (Day 0), Exit (Month 12 or sooner)|Safety Analysis Set, minus any missing data.|||Percentage of subjects|||Number
1458649|NCT00789555|Primary|Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner)|Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article.|Baseline (Day 0), Exit (Month 12 or sooner)|This analysis population includes all subjects who received study drug (Safety Analysis Set), minus any missing data.|||Percentage of subjects|||Number
1458650|NCT00789529|Secondary|Subject Questionnaire Response|"Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.~0=Very poor 50 = Excellent"|2 weeks||||units on a scale||Standard Deviation|Mean
1458651|NCT00789529|Primary|Objective, In-vivo Soft Contact Lens Wettability Index|The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack–Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.|2 weeks|Per protocol. All participants that completed both arms were analysed.|||wettability index||Standard Deviation|Mean
1458652|NCT00789477|Secondary|Number of Focal Laser Treatments||Week 1 to week 48|For the first 24 weeks, the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups did not receive laser treatment. From week 24 onward, participants in the Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) groups were allowed to receive laser rescue treatment.|||Treatments||Standard Deviation|Mean
1458653|NCT00789477|Secondary|Change From Baseline in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) - LOCF|Retinal thickness was evaluated using OCT at every visit except week 1. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52||||microns||Standard Deviation|Mean
1458654|NCT00789477|Secondary|Participants With Gains in ETDRS Letter Score of at Least 15 Letters - LOCF|Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 24 and week 52|FAS|||participants|||Number
1459265|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 72 Hours|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|72 hours|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with systematic bleeds|||Number
1458655|NCT00789477|Secondary|Change in BCVA From Baseline to Week 52 - LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF).|At week 52|FAS|||letters correctly read||Standard Deviation|Mean
1458656|NCT00789477|Primary|Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF)|"Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Measurements were taken at every study visit.~Missing values were imputed with post-baseline values during on-treatment period by using last observation carried forward (LOCF)."|At week 24|The FAS was used for the primary efficacy analysis. It included patients as randomized.|||letters correctly read||Standard Deviation|Mean
1458657|NCT00789438|Primary|Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints|Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.|Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay||||SPI and delta SPI (to baseline)||Standard Error|Median
1458658|NCT00789373|Secondary|Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off|Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.|Date of randomization to date of measured PD (up to 19.3 months)|All randomized participants|||percentage of participants||95% Confidence Interval|Number
1458659|NCT00789373|Secondary|Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off|Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.|Baseline to date of measured progressive disease (up to 19.3 months)|All randomized participants|||percentage of participants|||Number
1458660|NCT00789373|Secondary|Percentage of Participants With Serious Adverse Events During Maintenance Phase|A summary of serious adverse events is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with all serious adverse events included.|||percentage of participants|||Number
1458661|NCT00789373|Secondary|Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase|A summary of non-serious AEs is located in the Reported Adverse Event Module.|Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)|Randomized population with 2% cut-off threshold for inclusion for 19.3 months and 5% for 49.7 months.|||percentage of participants|||Number
1458662|NCT00789373|Secondary|Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)||Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|All randomized participants|||percentage of participants|||Number
1458663|NCT00789373|Secondary|Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)|Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline.|||units on a scale||Standard Deviation|Mean
1458664|NCT00789373|Secondary|Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score|The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)|Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline.|||units on a scale||Standard Deviation|Mean
1458665|NCT00789373|Secondary|Overall Survival (OS)|OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.|Date of randomization to the date of death from any cause up to 39.5 months|All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.|||months||95% Confidence Interval|Median
1458666|NCT00789373|Secondary|Independently-assessed Objective Progression-free Survival (PFS)|To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)|Randomized participants with reviewable scan--(316/359 [88%] Maintenance arm and 156/180 [87%] Placebo comparator arm. The majority of unread scans (12.4%) were due to participants not completing 1 cycle of treatment by the data cutoff date (30 June 2010).|||months||95% Confidence Interval|Median
1458667|NCT00789373|Primary|Investigator-assessed Objective Progression-free Survival (PFS)|Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.|Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)|All randomized participants|||months||95% Confidence Interval|Median
1458668|NCT00789321|Secondary|Change From Baseline in Foot Volume by Water Displacement (Weight of Water Displaced) at Week 2|Least Squares Mean Difference from Baseline|Baseline and 2 weeks|All patients treated with water displacement measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2) – two patients in the amlodipine group were excluded due to technical/procedural errors.|||Grams||Standard Deviation|Least Squares Mean
1458669|NCT00789321|Primary|Change From Baseline in Segmental Bioimpedance Measurements at 10 Kilohertz (KHz) at Week 2|Segmental biomimpedance was measured using a multifrequency analyzer (ImpediMed SFB7). The device was used to measure impedance (measured in Ohms) of a small current traveling between leads placed at the ankle and knee. Least Squares Mean Difference from Baseline in impedance is the primary endpoint.|Baseline and 2 weeks|All patients treated with segmental bioimpedance measurements at baseline and 2 weeks – one patient in the placebo group was not included (dropped out of study due to viral infection prior to Week 2).|||Ohms||Standard Deviation|Least Squares Mean
1458670|NCT00789256|Secondary|Determine Correlation Between in Vitro and in Vivo Activity of the Combination of Bortezomib and Melphalan.||7 Years|||||||
1458671|NCT00789256|Secondary|Determine Safety Profile of the Combination of Bortezomib and Melphalan.||7 Years|||||||
1458672|NCT00789256|Primary|Response Rate of the Combination of Bortezomib and Melphalan in Patients With AML and High-risk MDS.|Determine disease response to treatment using Cheson 2000 report of an international working group to standardize response criteria for myelodysplastic syndromes.|7 Years||||participants|||Number
1458673|NCT00789191|Secondary|Self-measured 9-point Plasma Glucose Profile||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||mmol/L||Standard Error|Mean
1458674|NCT00789191|Secondary|Hypoglycemic Episodes: Night Time|Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1458675|NCT00789191|Secondary|Hypoglycemic Episodes: Day Time|Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1458676|NCT00789191|Secondary|Hypoglycemic Episodes|Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L|Weeks 0-26|SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product.|||episodes|||Number
1458677|NCT00789191|Secondary|FPG (Fasting Plasma Glucose)||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||mmol/L||Standard Error|Mean
1458678|NCT00789191|Secondary|Change in Body Weight||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||kg||Standard Error|Mean
1458679|NCT00789191|Secondary|Change in BMI (Body Mass Index)||Week 0, Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||kg/m^2||Standard Error|Mean
1458680|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1458681|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1458682|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia|Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia|Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1458683|NCT00789191|Secondary|Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%||Week 26|FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Subjects|||Number
1458684|NCT00789191|Primary|HbA1c (Glycosylated Haemoglobin A1c)||Week 26|Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.|||Percent (%) glycosylated haemoglobin||Standard Error|Mean
1458685|NCT00789113|Primary|Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG|To evaluate the absolute bioavailability of immediate release (IR) and extended release (ER) lamotrigine (LTG) via blood and urine sampling for 24 hour period followed by once a day blood sampling for 3 days following initial dose administration.|1 week||||µg*h/mL||95% Confidence Interval|Geometric Mean
1458686|NCT00789074|Secondary|Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence|"Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).~* The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual)."|Week 4 - 8|Participants who were abstinent at 1 week and provided data on withdrawal symptoms|||Scores on a scale||Standard Deviation|Mean
1458688|NCT00789074|Secondary|Change in Pre-quit Ratings of Cigarette Satisfaction|"Satisfaction measured on a scale of 1-5; Have you found your cigarettes more or less enjoyable than usual in the last week? 1= much more and 5 = much less"|Baseline - week 4|Participants who provided ratings of cigarette satisfaction at each visit|||units on a scale||Standard Deviation|Mean
1458689|NCT00789074|Secondary|Change in Pre-quit Cotinine Levels|Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.|Weeks 1-4 (the first 4-weeks after first medication dose)|All participants that provided data at all time points|||ng/ml||Standard Deviation|Mean
1458690|NCT00789074|Secondary|Change in Pre-quit End-expired Carbon Monoxide Reading (CO)|"Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.~CO was measured at each contact to monitor changes in smoke intake and differences between the study arms."|Baseline - week 8|Participants that provided data at all time points|||ppm||Standard Deviation|Mean
1458691|NCT00789074|Primary|Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale|The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.|24 hours and 7 days after quit date (week 4)|Were abstinent and provided data at 24 hours post quit date|||units on a scale||Standard Deviation|Mean
1458692|NCT00789035|Secondary|Trough Concentrations of Empagliflozin in Plasma|Pre-dose (within 30 minutes before dosing) trough concentrations of Empagliflozin in plasma|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1458693|NCT00789035|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||kg||Standard Error|Mean
1458694|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5). Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU / mmol||Standard Error|Mean
1458695|NCT00789035|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L x mmol/L||Standard Error|Mean
1458696|NCT00789035|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L||Standard Error|Mean
1458697|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%).|12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1458698|NCT00789035|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%).|12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1458699|NCT00789035|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS, classical last observation carried forward (CLOCF) was used as the imputation method.|||percentage of HbA1c||Standard Error|Mean
1458700|NCT00789035|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|FAS (LOCF)|||mg/dL||Standard Error|Mean
1458701|NCT00789035|Primary|Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment|"Change of HbA1c from baseline after 12 weeks of treatment.~Note, adjusted means are presented. For the placebo and empa groups, measured values presented are for the model including only these treatment groups, for the metformin group the measured values presented are for the model including only placebo and metformin groups."|Baseline and 12 weeks|The full analysis set (FAS) consists of all randomised patients who were treated with at least 1 dose of study drug and had a baseline measurement of the primary endpoint. Modified last observation carried forward was used as the imputation method (LOCF).|||percentage of HbA1c||Standard Error|Mean
1458702|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Ganitumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1458703|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Ganitumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1458704|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Rilotumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1458705|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Rilotumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1458706|NCT00788957|Secondary|Part 2: Minimum Observed Drug Concentration During the Dosing Interval (Cmin) for Panitumumab|Concentration represents the Cmin from the previous dose (eg, Week 3 Cmin is the Cmin after the 1st dose).|Pre-dose at Weeks 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1465461|NCT00736580|Primary|Surgical Glove Perforation.|Direct measurement of the number of glove perforations listed by surgical case.|1 week||||Cases with a glove puncture|||Number
1458707|NCT00788957|Secondary|Part 2: Maximum Observed Drug Concentration During the Dosing Interval (Cmax) for Panitumumab||Pre-dose and 5 minutes after the completion of infusion at Weeks 1, 3, 5, 7, 13 and 23.|Part 2 participants with available pharmacokinetic data at each time point (indicated by n).|||μg/mL||Standard Deviation|Mean
1458708|NCT00788957|Secondary|Part 1: Area Under the Drug Concentration-time Curve During a Dosing Interval (AUCtau) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.|||day*μg/ml||Standard Deviation|Mean
1458709|NCT00788957|Secondary|Part 1: Maximum Observed Drug Concentration (Cmax) and Minimum Drug Concentration (Cmin) for Panitumumab and Rilotumumab||Week 5 (third dose) at pre-dose, 5 minutes after infusion and at 24, 48 and 96, and 168 hours post infusion.|Part 1 participants for whom intensive pharmacokinetic samples after the third dose (Week 5) were available.|||μg/ml||Standard Deviation|Mean
1458710|NCT00788957|Secondary|Number of Participants With Antibody Formation to Panitumumab, Rilotumumab and Ganitumab|Validated immunoassays were used to detect anti-panitumumab, anti-rilotumumab and anti-ganitumab binding antibodies.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set participants with at least one post-baseline immunoassay result.|||participants|||Number
1458711|NCT00788957|Secondary|Number of Participants With Grade 3 or Higher Laboratory Toxicities|The severity of laboratory toxicities was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal.|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).|||participants|||Number
1458712|NCT00788957|Secondary|Number of Participants With Adverse Events (AEs)|A serious adverse event (SAE) is defined as an AE that is fatal, life threatening (places the participant at immediate risk of death), requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. AEs were graded for severity according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 3: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. AEs were assessed by the investigator for the relationship of the AE to each one or more of the investigational products by the question: “Is there a reasonable possibility that the event may have been caused by the investigational product?”|From the first dose date to 30 days after the last dose of study drug, up to the data cutoff date of 08 February 2012. Median time on treatment was 5.2 months for Part 1, 2.8, 3.9 and 4.2 months for each Part 2 treatment arm respectively.|Safety analysis set (all enrolled participants who received at least 1 dose of investigational product).|||participants|||Number
1458713|NCT00788957|Secondary|Overall Survival|The interval from the first dose of study therapy to the date of death. Participants still alive at the analysis data cutoff date were censored at their last contact date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||months||95% Confidence Interval|Median
1458714|NCT00788957|Secondary|On-treatment Progression-free Survival|An event is defined as a radiographic progression or death that occurred from the first dose to 28 days since the last dose of study therapy. Participants who did not progress or die during this period were censored at their last evaluable disease assessment before the end of the 28-day period. Participants who received Part 3 treatment before 28 days since their last dose of study drug in Part 2 and did not have radiographic progression or die were censored at their last evaluable disease assessment prior to receiving therapy in Part 3. Radiographic progressions after start of a new anti-tumor therapy, including Part 3 treatment, or after 28 days since the last dose in Part 2 were excluded from the analysis. Participants who died with no prior radiographic disease progression during Part 3 treatment, but within the 28-day period since the last dose in Part 2 were considered as having an event.|From the date of first dose until 28 days after the last dose until the data cut-off date of 23 July 2010. Median time on treatment was 3.7, 4.9 and 5.1 months in each treatment arm respectively.|Efficacy analysis set|||months||95% Confidence Interval|Median
1458715|NCT00788957|Secondary|Progression-free Survival|The interval from the first dose of study therapy to the earlier date of disease progression (per modified-RECIST v1.0) or death. Participants who did not progress or die by the analysis data cutoff date were censored at their last evaluable disease assessment date prior to the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and receiving study treatment in Part 3 where applicable. Participants enrolled into Part 3 or who started a new line of anti-tumor therapy before radiographic progression but subsequently died were considered as having an event with the event date same as the death date.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||months||95% Confidence Interval|Median
1458716|NCT00788957|Secondary|Part 2: Percentage of Participants With Disease Control|The percentage of participants with an overall objective response of CR, PR, or stable disease (SD). CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD). SD: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for PD and no progression of non-target lesions, or the persistence of one or more non-target lesion(s) not qualifying for either CR or PD.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set|||percentage of participants||95% Confidence Interval|Number
1458717|NCT00788957|Secondary|Part 2: Time to Response|The interval from the first dose of study therapy to the date of the first confirmed objective response, calculated only for participants with an objective response.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.|||months||95% Confidence Interval|Median
1474761|NCT00670462|Secondary|Blood Pressure||baseline, 6, 12, 18, and 30 months|||||||
1458718|NCT00788957|Secondary|Part 2: Duration of Response|The interval from the first visit of a confirmed objective response to disease progression as defined by the modified RECIST v1.0 criteria. Participants who did not progress by the earlier of the analysis data cutoff date, initiating a new line of anti-tumor therapy, and the start of Part 3 dosing where applicable were censored at their last evaluable disease assessment date prior to the end of reporting period. Progressive disease is defined as at least a 20% increase in the size of target lesions, or unequivocal progression of existing non-target lesions, or any new lesions.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set; participants with an objective response of CR or PR.|||months||95% Confidence Interval|Median
1458719|NCT00788957|Primary|Part 2: Percentage of Participants With an Objective Response|An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.|From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.|Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.|||percentage of participants|||Number
1458720|NCT00788957|Primary|Part 1: Number of Participants With Dose-limiting Toxicities (DLT)|A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator|7 weeks|The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.|||participants|||Number
1458721|NCT00788892|Secondary|Aplasia Rate|Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.|Day 14 (1st Induction)|Efficacy Evaluable Analysis Set|||Participants|||Count of Participants
1458722|NCT00788892|Secondary|Rate of Stem Cell Transplant|The rate of patients who underwent stem cell transplant.|Up to 1 year|Efficacy Evaluable Analysis Set|||Participants|||Count of Participants
1458723|NCT00788892|Secondary|Overall Survival Rate at 1 Year|Survival defined as the time from randomization to death.|1 year|Efficacy Evaluable Analysis Set|||participants|||Number
1458724|NCT00788892|Secondary|Event Free Survival|Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.|Up to 1 year from randomization|Efficacy Evaluable Analysis Set|||days||95% Confidence Interval|Median
1458725|NCT00788892|Secondary|Remission Duration/Time to Remission|"Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.~Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met."|Following achievement of CR over the study period|Efficacy Evaluable Analysis Set|||days||Full Range|Median
1458726|NCT00788892|Primary|Number of Participants With Complete Remission|Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.|Within 6 weeks of the last induction treatment|Efficacy Evaluable Analysis Set: All randomized subjects who received at least 1 dose of study drug. One subject who developed Philadelphia chromosome positive disease prior to any efficacy assessment was excluded from the Efficacy Analysis Set.|||Participants|||Count of Participants
1458727|NCT00788775|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).||||participants|||Number
1458728|NCT00788775|Secondary|Overall Survival|Overall survival (OS) is defined as the time from study entry to death or date last known alive.|Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 16.2 months (90%CI 11.7-17.7 months; no/with CNS mets 16.2m/ 11.7m).|The analysis dataset is comprised of treated patients.|||months||90% Confidence Interval|Median
1458729|NCT00788775|Secondary|Progression-Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 5.5 months (range 0-45; no/with CNS mets 7.4m/ 3m).|The analysis dataset is comprised of treated patients.|||months||90% Confidence Interval|Median
1465823|NCT00734539|Secondary|Chronic Lung Disease||36 weeks corrected gestational age|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1458730|NCT00788775|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of treated patients.|||proportion of patients||90% Confidence Interval|Number
1458731|NCT00788710|Secondary|Average Elicited Pain Upon Sitting Over Days 1 to 3|Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 days|Full analysis set population|||Score on a scale||Standard Error|Least Squares Mean
1458732|NCT00788710|Secondary|Average Total Daily Dose of Morphine Over Days 1 to 3||3 days|Full analysis set population|||milligrams (mg)||Standard Error|Least Squares Mean
1458733|NCT00788710|Primary|Average Pain Intensity at Rest Over Days 1 to 3|Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.|3 Days|Full analysis set population|||Score on a scale||Standard Error|Least Squares Mean
1458734|NCT00788697|Secondary|Inter-reader Agreement|Inter-reader agreement of assessment of malignant or benign by unenhanced and SonoVue-enhanced ultrasonography separately. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized. Computation for the percentage agreement within two categories: “3 out of 3 readers agree” and “2 out of 3 readers agree”.|24 hours to 6 months||||Percent of total number of lesions|||Number
1458735|NCT00788697|Secondary|Specific Diagnosis of Benign FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 116 ITD participants with benign lesions based on the truth standard, only 89 participants (lesions) were characterized as either hemangioma or focal nodular hyperplasia.|||Benign lesions|Benign lesions to be characterized||Number
1458736|NCT00788697|Secondary|Specific Diagnosis of Malignant FLLs|"SonoVue-enhanced versus unenhanced ultrasound for specific diagnosis of malignant FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of correctly characterized lesions/number of lesions per truth standard) x 100."|24 hours to 6 months|Among the 124 ITD participants with malignant lesions based on the truth standard, only 115 participants (lesions) were characterized as either hepatocellular carcinoma (HCC) lesions or metastatic lesions.|||Malignant lesions|Malignant lesions to be characterized||Number
1458737|NCT00788697|Secondary|Negative Predictive Value (NPV): Percentage of True Negative Lesions Among All Malignant Lesions Per Ultrasound|"Negative Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per ultrasound) x 100."|24 hours to 6 months|Among the 240 ITD participants, the overall number of participants (lesions) assessed as benign varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent negative lesions by ultrasound|Negative lesions|95% Confidence Interval|Number
1458738|NCT00788697|Secondary|Positive Predictive Value (PPV): Percentage of True Positive Lesions Among All Malignant Lesions Per Ultrasound|"Positive Predictive Value of SonoVue-enhanced versus unenhanced ultrasound for characterization of FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per ultrasound) x 100."|24 hours to 6 months|Among the 240 ITD participants, the overall number of participants (lesions) assessed as malignant varied based on the evaluation of the UE-US and CE-US made by each off-site Reader.|||Percent positive lesions by ultrasound|Positive lesions|95% Confidence Interval|Number
1458739|NCT00788697|Secondary|Accuracy: Percentage of True Positive and True Negative Among All Lesions|"The Accuracy of SonoVue-enhanced versus unenhanced ultrasound for characterization of malignant and benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive and true negative lesions/number of total lesions per truth standard) x 100."|24 hours to 6 months|240 participants in the ITD population|||Percent true positive and negative lesio|Total lesions|95% Confidence Interval|Number
1459266|NCT00784134|Secondary|Safety/Mortality - Bacterial Brain Infections Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with brain infection|||Number
1458740|NCT00788697|Primary|Specificity: Percentage of True Negative Lesions Among All Malignant Lesions Per Truth Standard|"Specificity of SonoVue-enhanced versus unenhanced ultrasound for characterization of benign FLLs, using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the ITD population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True negative: subject with a target lesion characterized as benign by both ultrasonography and the truth standard.~Truth standard: CE-CT and /or CE-MRI examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true negative lesions/number of benign lesions per truth standard) x 100."|24 hours to 6 months|Among the 240 ITD participants, only 116 participants (lesions) were benign based on the truth standard and were included for specificity.|||Percentage of true negative lesions|Benign lesions|95% Confidence Interval|Number
1458741|NCT00788697|Primary|Sensitivity: Percentage of True Positive Lesions Among All Malignant Lesions Per Truth Standard|"Sensitivity of SonoVue-enhanced ultrasound (SonoVue CE-US) versus unenhanced ultrasound (UE-US) for characterization of malignant focal liver lesions (FLLs), using the diagnosis provided by each of the 3 off-site assessors (blinded to patient data) for the Intent-to-Diagnose (ITD) population. Unit of analysis was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.~True positive: subject with a target lesion characterized as malignant by both ultrasonography and the truth standard.~Truth standard: contrast-enhanced computed tomography (CE CT) and /or contrast-enhanced magnetic resonance imaging (CE-MRI) examination OR tissue pathology/histology from surgical resection/biopsy OR 6-month follow up. Calculated as (number of true positive lesions/number of malignant lesions per truth standard) x 100."|24 hours to 6 months|Among the 240 ITD participants, only 124 participants (lesions) were malignant based on the truth standard and were included for sensitivity.|||Percentage of true positive lesions|Malignant lesions|95% Confidence Interval|Number
1458742|NCT00788593|Secondary|Change From Placebo Baseline in Body Mass Index (BMI) at End of Treatment|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Mean change from baseline in BMI was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."|||kg/m^2||Standard Deviation|Mean
1458743|NCT00788593|Secondary|Change From Placebo Baseline in Weight at End of Each Treatment Period|Mean change from baseline in weight was calculated for end of treatment (6 days home treatment and 3-5 days hospital treatment) in first and second intervention periods.|Baseline, end of treatment (6 days home treatment and 3-5 days hospital treatment in first and second intervention periods)|"FAS included all participants who received at least one dose of the study medication. Here N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||kilogram (kg)||Standard Deviation|Mean
1458744|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Nitrogen Absorption (CNA) During Hospital Treatment|Percent CNA was calculated as [(nitrogen intake - nitrogen excretion)/nitrogen intake]*100 , determined in the stools collected during the 72-hour CNA determination period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least one dose of the study drug. Here N (number of participants analyzed) represents number of participants who were evaluable for this outcome measure."|||percent CNA||Standard Deviation|Mean
1458745|NCT00788593|Secondary|Change From Placebo Baseline in Percent Coefficient of Fat Absorption (CFA) in High Dose EUR-1008 and Low Dose EUR-1008 During Hospital Treatment|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for 3 to 5 days of hospital treatment in first and second intervention periods.|Baseline, 3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."|||percent CFA||Standard Deviation|Mean
1458746|NCT00788593|Primary|Percent Coefficient of Fat Absorption (CFA) of Participants Treated With High Dose EUR-1008 and Low Dose EUR-1008|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.|3 to 5 days of hospital treatment in first and second intervention periods|"FAS included all participants who received at least 1 dose of the study medication. Here N (number of participants analyzed) signifies those participants for whom the CFA values were available."|||percent CFA||Standard Deviation|Mean
1458747|NCT00788372|Primary|Brief Pain Inventory-Short Form (BPI-SF) Total Score|The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1458788|NCT00787891|Primary|The Percentage of Patients With Healing by Week 12 (Short-term Double-blind Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|12 weeks|Intention to Treat (ITT) analysis set|||Percentage of participants||95% Confidence Interval|Number
1458789|NCT00787852|Secondary|Complete and Partial Response by CT Scan or MRI||within 30 days of last treatment|||||||
1475894|NCT00662311|Secondary|Duration of Response||Up to 3 years||||months||Full Range|Median
1458748|NCT00788372|Primary|Participants Overall Assessment|The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
1458749|NCT00788372|Primary|Physician’s Global Assessment Scale|The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||participants|||Number
1458750|NCT00788372|Primary|Short-Form 36-Item Health Survey (SF-36) Scores|The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1458751|NCT00788372|Primary|Number of Rescue Treatments|Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported.|Week 52 or final evaluation (early discontinuation)|The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||treatments per day||Standard Deviation|Mean
1458752|NCT00788372|Primary|Number of Participants With Quality of Sleep|The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1458753|NCT00788372|Primary|Number of Participants With Total Painful Time Per Day|The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day.|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1458754|NCT00788372|Primary|Number of Participants With Pain Assessed by Categorical Scale for Pain|Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable).|Week 52 or final evaluation (early discontinuation)|The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1458755|NCT00788372|Primary|Pain Visual Analogue Scale Score|"Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Week 52 or end point (early discontinuation)|Full Analysis Set (FAS) population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application.|||mm||Standard Deviation|Mean
1458756|NCT00788372|Primary|Dependence Questionnaire (DQ)|The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug.|Week 52 or end point (early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||units on a scale|||Number
1458790|NCT00787852|Primary|Number of Patients Who Came Off Study for Toxicity Using CTC Version 3.0|6 patients came off study for toxicity|within 28 days after the last radiation treatment||||participants|||Number
1462763|NCT00759902|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1458757|NCT00788372|Primary|Questionnaire of Opioid Withdrawal Symptoms|Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal.|Week 52 or endpoint (1 week after last treatment or early discontinuation)|Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
1458758|NCT00788255|Primary|TTG|thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)|6 months||||mm||Standard Deviation|Mean
1458759|NCT00788255|Primary|Tmax|thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)|6 months||||minutes||Standard Deviation|Mean
1458760|NCT00788255|Primary|MRTG|thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)|6 months||||mm/min||Standard Deviation|Mean
1458761|NCT00788255|Primary|MA|thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)|6 months||||mm||Standard Deviation|Mean
1458762|NCT00788255|Primary|Alpha Angle|thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)|6 months||||degrees||Standard Deviation|Mean
1458763|NCT00788255|Primary|k Time|thromboelastographic indices - clot formation time (normal range, 1-3 min)|6 months||||minutes||Standard Deviation|Mean
1458764|NCT00788255|Primary|r Time|thromboelastographic indices - reaction time (normal range, 5-10 min)|6 months||||minutes||Standard Deviation|Mean
1458765|NCT00788073|Post-Hoc|ABC-FXS Social Avoidance Subscore|After completion of the study, but during data analysis, the ABC-C assessment was independently re-validated in Fragile X Syndrome subjects. The subscales were re-factored into a Fragile-X Syndrome specific ABC-C (ABC-FX). The ABC-FX contains the same 58 questions as the original ABC-C but there are six subscales. One of the subscales is Social Avoidance, which consists of 4 items. Minimum score is 0, maximum is 12. A decreased score indicates fewer social avoidant behaviors. A post-hoc analysis was performed from the study data examining the social avoidance subscale of the ABC-FX.|4 week treatment period||||Points on a scale||Standard Error|Least Squares Mean
1458766|NCT00788073|Primary|Aberrant Behavior Checklist Irritability Subscore|The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline and then at the end of each Intervention Period (4 weeks after Baseline).|After 4 weeks of treatment||||Points on a scale||Standard Error|Least Squares Mean
1458767|NCT00788008|Primary|Change in Neurocognitive Performance (Z-score)|"Mean change on composite scores (z-score) for memory and executive function measures.~Memory measures: Hopkins Verbal Learning Test–Revised and the Brief Visuospatial Memory Test–Revised.~Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination.~The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (<1%) to fall outside the -3.0 to +3.0 range.~Higher scores (and thus positive change value) indicate an improvement of function."|3 months post operatively||||z score||Full Range|Mean
1458768|NCT00787943|Primary|Number of Inflammatory Lesions (Papules and Pustules)|Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2.|4 Weeks|Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat.|||Lesions|||Number
1458769|NCT00787930|Secondary|fa ROFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.|||units on a scale||Standard Deviation|Mean
1458770|NCT00787930|Secondary|fa LOFC in Subjects Who Received Continuation Treatment|As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.|up to 12 months|Number of subjects in continuation phase who had MRIs that were able to be processed for DTI data.|||units on a scale||Standard Deviation|Mean
1458771|NCT00787930|Secondary|Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS).|up to 12 months|Number of subjects who who had >2 on the DWM hyperintensity assessment from the Boyko classification system.|||participants|||Number
1462764|NCT00759902|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr||Full Range|Median
1458772|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment|Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15.|12 months|Subjects who completed at least 4-12 months of consistent follow up appointments after stabilization from an acute manic episode. Note that 3 subjects dropped out of continuation treatment.|||participants|||Number
1458773|NCT00787930|Primary|Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania|Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions.|3 weeks|All subjects in an acute manic state who were treated with specified protocol.|||participants|||Number
1458774|NCT00787917|Secondary|Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||percentage of participants||Standard Error|Least Squares Mean
1458775|NCT00787917|Secondary|Change From Baseline in Average Oral Corticosteroid Use.||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||mg/day||Standard Deviation|Mean
1458776|NCT00787917|Secondary|Time to Steroid Free State.||12 months|No statistical analysis was performed due to insufficient study enrollment|||days||Standard Deviation|Mean
1458777|NCT00787917|Secondary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment||3 months, 6 months|No statistical analysis was performed due to insufficient study enrollment|||Liters||Standard Error|Least Squares Mean
1458778|NCT00787917|Secondary|Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period||6 months, 12 months|No statistical analysis was performed due to insufficient study enrollment|||percentage||Standard Error|Least Squares Mean
1458779|NCT00787917|Primary|Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen||6 months of blinded treatment|No statistical analysis was performed due to insufficient study enrollment|||percentage||Standard Error|Least Squares Mean
1458780|NCT00787904|Secondary|Bone Mineral Density|Please note that the bone density measurements were done AFTER THE PRIMARY endpoints because bone mineral density changes take longer to see differences|2 years|||||||
1458781|NCT00787904|Primary|Percent Change in Thymus Size Measured by CT Scan||2 years||||percent change||Standard Deviation|Mean
1458782|NCT00787904|Primary|Changes in T-cell Activation Measured by Flow Cytometry, Specifically the Percentage of CD3+CD69+ T-cells|(Please note to reviewer, CD3 positivity indicates a T-cell, the title is correct)|2 years||||percentage of CD3 positive cells||Standard Deviation|Mean
1458783|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Double-blind Maintenance Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1458784|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Double-blind Maintenance Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 36|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1458785|NCT00787891|Secondary|The Change From Baseline in the Total GERD Symptom and Severity Score (Short-term Double-blind Treatment Phase)|The gastroesophageal reflux disease (GERD) symptom and severity scale measures the frequency (0= Never; 1= 1-2 times; 2= 3-4 times; 3= 5-6 times; 4= 7 or more times) and the severity (1= Mild; 2= Moderate; 3=Severe) of GERD symptoms. The score is defined as the sum of the frequency (0-4) and severity (1-3) of that symptom. The total score is the sum of the scores of all the symptoms and ranges from 12 to 84. Higher scores indicate more serious condition. For change from baseline, 0 indicates no change; a positive score indicates worsening, while a negative score indicates improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1458786|NCT00787891|Secondary|The Change From Baseline in the Hetzel and Dent Endoscopic Classification Grade Score (Short-term Double-blind Treatment Phase)|The Hetzel and Dent Classification grades range from 0 (normal esophageal mucosa, no abnormalities noted) to 4 (deep ulcers anywhere in the esophagus or ulceration of more than half of the esophageal mucosa). Higher observed scores indicate more serious condition. For change of baseline, a score of 0 indicates no change; a positive score indicates the condition is worsening, while a negative score indicates an improvement.|Baseline, Week 12|Intention to Treat (ITT) analysis set|||Scores on a scale||Standard Deviation|Mean
1458787|NCT00787891|Primary|The Percentage of Patients With Healing by Week 36 (Double-blind Maintenance Treatment Phase)|Healing is defined as macroscopically normal esophageal mucosa or histologic normal esophageal mucosa.|36 weeks|Intention to Treat (ITT) analysis set|||Percentage of patients||95% Confidence Interval|Number
1459267|NCT00784134|Secondary|Safety/Mortality - Mortality Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Percentage of patients|||Number
1458791|NCT00787839|Secondary|Cost to Identify a Single Case of High-risk Dysglycemia or Previously Unrecognized Diabetes|Cost was expressed as cost (dollars) to identify a single case, with cases defined as (i) diabetes or (ii) high-risk dysglycemia. Cost projections for screening were conducted from both Medicare and VA perspectives. All screening projections assumed follow-up testing with an OGTT if the screening test exceeded a 70% specificity cut-off.|3 years||||Dollars|||Number
1458792|NCT00787839|Primary|Ability of Different Screening Tests Which Can be Performed Opportunistically (During Outpatient Visits -- at Any Time of Day, Regardless of Meal Status) to Predict Findings With the Oral Glucose Tolerance Test (in the Morning, After an Overnight Fast)|"Area under ROC curve (AROC) for prediction of diabetes (based on OGTT) and high-risk dysglycemia (based on OGTT, IGT with 2 hour OGTT glucose 140-199 mg/dl, and/or IFG with fasting glucose 110-125 mg/dl).~ROC curves are plots of (1-sensitivity) vs. (1-specificity) for all possible screening cutoffs, so a higher AROC indicates higher predictive accuracy. A perfect test would have an AROC of 1.00, while a test equivalent to tossing a coin (random) would have an AROC of 0.50; if confidence limits include 0.50, predictive accuracy is no better than chance.~It is important to appreciate that while AROC analysis can show the relative accuracy of different screening tests, and aid the selection of which test to use in clinical practice, such an analysis does not define what the optimal screening test cutoff is. Selection of the optimal cutoff generally requires consideration of other factors, such as costs and/or the clinical importance of having higher or lower sensitivity."|3 years||||area under ROC curve||95% Confidence Interval|Number
1458793|NCT00787800|Secondary|Atrial Fibrillation (AF) Burden|AF burden is defined as the sum of duration of all atrial arrhythmias divided by total observation time, reported as a percentage value.|Implantation through 1 year|Intent to treat analysis population.|||Percentage of atrial arrhythmias per min||Standard Deviation|Mean
1458794|NCT00787800|Secondary|Number of Subjects With Newly Detected Atrial Tachyarrhythmias||Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.|||Participants|||Number
1458795|NCT00787800|Secondary|Total Cost of ICD Implantation Procedure||Baseline|Only the 45 subjects enrolled at Mayo Clinic in Rochester, Minnesota were analyzed for ICD implantation costs.|||US Dollars||Standard Deviation|Mean
1458796|NCT00787800|Secondary|Number of Appropriate Shocks by ICD|Appropriate shocks are delivered during a sustained Ventricular Tachycardic/Ventricular Fibrillation heart rhythm.|Baseline to 12 Months|Intent to Treat population analyzed.|||Shocks|||Number
1458797|NCT00787800|Secondary|Number of Atrial Tachyarrhythmia Episodes Lasting Over 5 Minutes|Episodes of Atrial Fibrillation (AF) or Atrial Flutter (AFL) greater than 5 minutes duration. A subject may experience multiple episodes.|Baseline to 12 Months|Intent to Treat population analyzed. 37 episodes in 5 subjects (all in dual chamber arm).|||Episodes|||Number
1458798|NCT00787800|Primary|Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD)|An inappropriate shock is defined as a shock delivered by the ICD during a rhythm other than sustained VT/VF (ventricular tachycardia/ventricular fibrillation).|Baseline to 12 months after ICD implantation|Intent to Treat population analyzed.|||Participants|||Number
1458799|NCT00787787|Secondary|Median Overall Survival|Survival estimated by Kaplan-Meier method|From start of treatment until death from any cause, assessed up to 3 years||||days||Full Range|Median
1458800|NCT00787787|Secondary|Best Response by RECIST Criteria|Incidence rate of best clinical response (complete response [CR], partial response [PR], stable disease [SD], or progressive disease[PD]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years|Only 4 patients in this study had assessments of response by RECIST criteria.|||Participants|||Count of Participants
1458801|NCT00787787|Primary|Median Progression-free Survival|Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment to time of progression or death from any cause, assessed up to 3 years||||days||Full Range|Median
1458802|NCT00787761|Secondary|Overall Survival (OS) at 24 Months|Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease.|24 months|23 patients were able to be analyzed for OS at 24 months|||participants|||Number
1458803|NCT00787761|Secondary|Disease-free Survival (DFS) at 24 Months|Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted.|24 months|23 patients were able to be analyzed for DFS at 24 months|||participants|||Number
1458804|NCT00787761|Secondary|Non-relapse Mortality (NRM) at Day 180 Post-transplantation|non-relapse mortality refers to the death of a patient for causes other than relapsed disease.|Day 180|23 patients were able to be analyzed for NRM at 180 days|||participants|||Number
1458805|NCT00787761|Secondary|Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)|Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|2 years|23 patients were able to be analyzed for severe gvhd|||participants|||Number
1458806|NCT00787761|Secondary|Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease|number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.|Day 100|23 patients were able to be analyzed for severe gvhd|||participants|||Number
1458846|NCT00787267|Secondary|Grade 3-5 Toxicity Associated With Dasatinib Treatment|Number of subjects with Grade 3-5 toxicity as assessed using NCI CTCAE criteria with the attribution of possibly, probably, or definitely related to protocol treatment.|Duration of dasatinib treatment plus 30 days|All subjects who received at least one dose of dasatinib were included in the analysis.|||participants|||Number
1458807|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|180 days|20 of the patients treated on study had chimerism drawn on day 180.|||participants|||Number
1458808|NCT00787761|Secondary|T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|20 of the patients treated on this study had Day 90 chimerism drawn.|||participants|||Number
1458809|NCT00787761|Primary|Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|only 15 of the patients treated on study had Day 30 chimerism results.|||participants|||Number
1458810|NCT00787644|Primary|PC20|"Airway reactivity will be measured with methacholine challenge testing following ATS guidelines.~This is the concentration of methacholine that produces a 20% decrease in lung function (measured by forced expiratory volume in 1 second)"|12 weeks||||mg/ml||Standard Deviation|Median
1458811|NCT00787618|Primary|Cmax of Proellex||48 hours|Study prematurely terminated||||||
1458812|NCT00787605|Secondary|Evaluate the Safety and Tolerability|Percentage of patients with Adverse Event and percentage of patients with edema|after 8 weeks of treatment|safety|||Percentage of participants|||Number
1458813|NCT00787605|Secondary|Biomarker Measurements|Geometric mean of the post to baseline ratio in biomarkers of plasma renin activity (ng/ml/h), plasma renin concentration (ng/L), and cystatin C (mg/L)|Baseline and Week 8|Full analysis set, intent-to-treat|||ratio||95% Confidence Interval|Geometric Mean
1458814|NCT00787605|Secondary|Percentage of Patients Achieving Blood Pressure Control|Blood pressure control is defined as patient achieving a target Blood Pressure of mean sitting Systolic BloodPressure / mean sitting Diastolic Blood Pressure < 130/80 mmHg.|after 8 weeks of treatment|Full analysis set, intent-to-treat|||Percentage of Participants|||Number
1458815|NCT00787605|Secondary|Percentage of Responders|Response defined by mean sitting Systolic Blood Pressure < 130 mm Hg or a reduction of mean sitting Systolic Blood Pressure >= 20 mm Hg from baseline|Week 8|Full analysis set, intent-to-treat|||Percentage of Participants|||Number
1458816|NCT00787605|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)||Baseline and Week 8|Full analysis set, intent-to-treat|||mmHg||Standard Error|Least Squares Mean
1458817|NCT00787605|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)||Baseline and Week 8|Full analysis set, intent-to-treat|||mmHg||Standard Error|Least Squares Mean
1458818|NCT00787566|Secondary|Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS|VAS (visual analog scale) 0: not at all satisfied, 100: totally satisfied|24 hours|||||||
1458819|NCT00787566|Secondary|Severity of Nausea Measured by a 4 Categorical Scale|4 categorical scale: none, mild (did not interfere with normal daily life), moderate (interfered with normal daily life), and severe (bedridden due to nausea/ required the patient to be bedridden)|24 hours|||||||
1458820|NCT00787566|Secondary|Number of Emetic Episodes||24 hours|||||||
1458821|NCT00787566|Secondary|Time to Treatment Failure|Time to treatment failure is based on time to first emetic episode or time to rescue medication, whichever occurs first|24 hours|||||||
1458822|NCT00787566|Secondary|Time to First Rescue Medication||24 hours|||||||
1458823|NCT00787566|Secondary|Time to First Emetic Episode||24 hours|||||||
1458824|NCT00787566|Secondary|Percentage of Patients Using Rescue Medications||24 hours|||||||
1458825|NCT00787566|Secondary|Percentage of Patients With Failure|Failure: > 5 emetic episodes|24 hrs|||||||
1458826|NCT00787566|Secondary|Percentage of Patients With Minor Control of Emesis|Minor Control of emesis: 3-5 emetic episodes|24 hrs|||||||
1458827|NCT00787566|Secondary|Percentage of Patients With Major Control of Emesis|Major Control of emesis = 2 emetic episodes|24 hrs|||||||
1458828|NCT00787566|Secondary|Percentage of Patients With Total Response|Total Response is defined as no nausea, no emetic episodes, and no use of rescue medications|24 hours|||||||
1458829|NCT00787566|Secondary|Percentage of Patients With Complete Response|Complete Response is defined as no emetic episodes and no use of rescue medications|24 hours|||||||
1458830|NCT00787566|Primary|Percentage of Patients With Complete Control|Complete Control is defined as no emetic episodes, no use of rescue medications, and no more than mild nausea as defined by a categorial scale.|24 hours|ITT population|||Percentage|||Number
1458831|NCT00787527|Primary|Phase II MTD of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days||||mg/three times daily|||Number
1458832|NCT00787527|Primary|Number of Participants With Dose Limiting Toxicity for Determination Phase I (Schedule A) MTD of Vorinostat|MTD of Vorinostat defined as highest dose level in which 6 patients have been treated with less than 2 instances of DLT. Continual reassessment during each 21-day cycle to assess DLT. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle. The dose of Vorinostat escalated in successive 3+3 cohorts of participants to determine the MTD.|21 Days||||participants|||Number
1458833|NCT00787527|Primary|Phase I Maximum Tolerated Dose (MTD) of Vorinostat|MTD of Vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Continual reassessment during each 21-day cycle to assess dose limiting toxicity. Two schedules of Vorinostat were investigated: Phase I A) daily doses on days 5 to 14, or Phase II B) three times a day on days -2 to 3 of standard CHOP every 21 days. Vorinostat was administered orally on days 5 to 14 (Schedule A), first at 300 mg orally once daily (total doses of 3000 mg over 10 days per cycle), and next at 200 mg orally twice daily (total doses of 4000 mg over 10 days per cycle); and for Phase II Schedule B Vorinostat administered orally 300 mg orally three times daily from days -2 to 3 (4500 mg over 5 days per cycle).|21 Days||||mg/day|||Number
1458834|NCT00787332|Primary|New Thrombosis, Amputation, Death, Major and Minor Bleeding||30 days|All patients receiving drug|||participants|||Number
1458835|NCT00787319|Other Pre-specified|Physician's Assessment of Tolerability|Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||participants|||Number
1458836|NCT00787319|Other Pre-specified|Mean Number of Doses of Study Medication Received||Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||doses||Standard Deviation|Mean
1458837|NCT00787319|Other Pre-specified|Duration of Treatment|Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||weeks||Standard Deviation|Mean
1458838|NCT00787319|Other Pre-specified|Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to Week 104 (EOS)|Safety analysis set included all enrolled participants who received study medication.|||participants|||Number
1458839|NCT00787319|Other Pre-specified|Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring|Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|Safety analysis set included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||participants|||Number
1458840|NCT00787319|Secondary|Physician's Assessment of Efficacy|Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.|Week 104 or End of study (EOS)|FAS included all enrolled participants who received study medication.|||participants|||Number
1458841|NCT00787319|Secondary|Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.|Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||participants|||Number
1458842|NCT00787319|Secondary|Change From Baseline in Visual Acuity (VA) at Each Visit|VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102|FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. ‘n' signifies participants evaluated at each time point, respectively.|||logMAR||Standard Deviation|Mean
1458843|NCT00787319|Primary|Change From Baseline in Visual Acuity (VA) at Final Visit|Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.|Baseline, Final Visit (Week 104 or early termination [ET])|Full analysis set (FAS) included all enrolled participants who received study medication. Missing values were imputed using last observation carried forward (LOCF) method.|||logMAR||Standard Deviation|Mean
1458844|NCT00787267|Secondary|Determine Relationship Between K-ras Gene Mutation and Response to Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.||||||
1458845|NCT00787267|Secondary|Describe Change in Serum Levels of C-terminal Cross-linked Collagen I Between Pre-treatment and 6 Weeks After Starting Dasatinib.||2 years|Assays were not run because no objective tumor response was observed.||||||
1460259|NCT00776295|Primary|Number of Subjects Meeting 1-year Overall Survival|Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death|up to one year||||participants|||Number
1458848|NCT00787267|Primary|Tumor Response|"Tumor response rate was defined by RECIST criteria:~CR (complete response) = disappearance of all target lesions taking as reference the baseline sum of the longest diameter (LD); PR (partial response) = at least a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = at least a 20% increase in the sum of the longest diameter of target lesions as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD (stable disease) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started"|2 years|Unable to determine the response for 9 subjects.|||participants|||Number
1458849|NCT00787254|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|Per Incidence (up to 24 months).||||participants|||Number
1458850|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458851|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458852|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458853|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458854|NCT00787254|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458855|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)|The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458856|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458857|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458858|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458859|NCT00787254|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458860|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1460260|NCT00776230|Secondary|Secondary: 1. Seroconversion Rate 2. GMTs Day 28, Month 6 and Month 12 3. Treatment Emergent Adverse Events 4. Systemic and Local Tolerability||see above|||||||
1481529|NCT00613405|Secondary|Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)||~2 hours|||||||
1458861|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458862|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458863|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458864|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458865|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458866|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458867|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458868|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458869|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458870|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)|The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458871|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458872|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458873|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458874|NCT00787254|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458875|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458876|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458877|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458878|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458879|NCT00787254|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458880|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)|The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458881|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458882|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458883|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458884|NCT00787254|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458885|NCT00787254|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|On occurrence (up to month 24).|On days where participants did not have an occurrence of gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) and who also underwent endoscopic examination were considered censored dates. Values are from the Full Analysis Set.|||participants|||Number
1458886|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458887|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458888|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458889|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458890|NCT00787254|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458891|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 24.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458892|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458893|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458894|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458895|NCT00787254|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1458896|NCT00787254|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|24 Months|Participants not taking investigational drug were not included.|||participants|||Number
1458897|NCT00787241|Secondary|Time Interval (Hours) From Closet Platelet Count to Initiation of Neuraxial Analgesia|Time interval in hours from the closest obtained platelet count to the initiation of neuraxial analgesia.|1 week to time of neuraxial analgesia||||Hours||Full Range|Median
1458898|NCT00787241|Secondary|Positive Predictive Value of Platelet Count Closet to Neuraxial Analgesia|The positive predictive value of the platelet count closest to neuraxial analgesia with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the closest platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the closest available platelet count multiplied by 100.|0 to 72 hours following delivery||||percentage of positive platelet counts|||Number
1458899|NCT00787241|Primary|Positive Predictive Value of Earliest Available Platelet Count|The positive predictive value of the earliest available platelet count with the maintenance of a platelet count greater than 80,000 during labor and delivery and removal of the epidural catheter was calculated. The test was considered true if the first platelet count was >150,000 platelets and the subsequent platelet counts remained above 80,000 platelets. The number of subjects with a test equal true was divided by the total number of subjects with a platelet counts >150,000 at the earliest available platelet count multiplied by 100.|0 to 72 hours following delivery||||percentage of positive platelet counts|||Number
1458900|NCT00787202|Secondary|Plasma Concentration of CP-690,550|Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter [ng/mL]) to zero.|0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8|Analysis population included all participants who had at least 1 plasma concentration. N=evaluable participants for this measure.|||ng/mL||Standard Deviation|Mean
1458901|NCT00787202|Secondary|Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||milligram per kilogram (mg/kg)||Standard Deviation|Mean
1458902|NCT00787202|Secondary|Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Week 4, 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||milligram per liter (mg/L)||Standard Deviation|Mean
1458903|NCT00787202|Secondary|Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Missing data were excluded. N=evaluable participants for the measure. n=number of participants at specified time point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
1458904|NCT00787202|Secondary|Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12|Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Baseline, Week 2, 4, 8, 12|FAS: all participants who either withdrew as TF or completed >=1 week of dosing, had >=1 valid Mayo score during active double-blind phase. Baseline-observation-carried-forward (BOCF) was used for participants who withdrew as TF. Missing data due to reasons other than treatment failure were excluded. N=evaluable participants for the measure.|||units on a scale||Standard Deviation|Mean
1458905|NCT00787202|Secondary|Percentage of Participants With Endoscopic Remission|Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
1458906|NCT00787202|Secondary|Percentage of Participants With Endoscopic Response|Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
1458907|NCT00787202|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|FAS: all participants who either withdrew as treatment failure TF or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF were treated as non-responders. Missing data due to reason other than TF were excluded. N=evaluable participants for the measure.|||percentage of participants|||Number
1458977|NCT00786565|Primary|Low Contrast Uncorrected Visual Acuity Following Cataract Surgery|Low contrast uncorrected visual acuity 3 months post cataract surgery|3 months|Full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy|||LogMAR||Standard Deviation|Mean
1482510|NCT00607243|Secondary|Antibody Response||14 or 28 days|||||||
1458908|NCT00787202|Primary|Percentage of Participants With Clinical Response|Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).|Week 8|Full analysis set (FAS): all participants who withdrew as treatment failure (TF) or completed >=1 week dosing, had >=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF=non-responders. Missing data due to reason other than TF were excluded. N (number of participants analyzed)=evaluable participants for the measure.|||percentage of participants|||Number
1458909|NCT00787189|Secondary|Tinnitus, Hearing-related Quality of Life||up to 6 months|||||||
1458910|NCT00787189|Primary|Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.|Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the CID W-22 lists. The percent of total words repeated correctly for each ear was recorded and the change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.|baseline and one week|ITT analysis.|||participants|||Number
1458911|NCT00787150|Other Pre-specified|Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of participants with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
1458912|NCT00787150|Other Pre-specified|Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban|Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not calculated. Therefore, 0 indicates not calculated.|Week 0, Week 1, Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Warfarin, Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||pmol/L||Standard Deviation|Mean
1458913|NCT00787150|Other Pre-specified|Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. Below the limit of quantification (BLQ) was assigned the value 0 for calculation. If 50% or more of the data was BLQ, statistics was not be calculated. Therefore, 0 means not calculated.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
1458914|NCT00787150|Other Pre-specified|Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban|Blood Sample at 4 hours postdose was collected if possible. The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||Second||Standard Deviation|Mean
1458915|NCT00787150|Other Pre-specified|Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban|Blood sample at 4 hours postdose was collected if possible. PT-INR is a standardized measure derived from prothrombin time (PT). The systematic variations in PT assay results are corrected in PT-INR in order to optimize measurements of vitamin K antagonists.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||International normalized ratio||Standard Deviation|Mean
1458916|NCT00787150|Other Pre-specified|Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8|The analysis set was based on all participants with relevant measurements. Participants were categorized to the actual treatment received. n=number of subjects with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||second||Standard Deviation|Mean
1458917|NCT00787150|Other Pre-specified|Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban|Sample at 4 hours postdose was to be taken if possible.|0, 2, 4 hours postdose at Week 1 and Week 8|The pharmacokinetic analysis set was defined as participants treated with apixaban, who were not assessed as major protocol violators, and in whom at least one observation of plasma apixaban concentration. n=number of participants with evaluable data in Apixaban 2.5 mg BID, Apixaban 5.0 mg BID, respectively.|||ng/mL||Standard Deviation|Mean
1458918|NCT00787150|Secondary|Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
1458978|NCT00786565|Primary|Low Contrast Best Corrected Visual Acuity Following Cataract Surgery|Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.|3 months|Number of participants 67 total with 67 eyes in each group, full analysis set, all randomized participants who had cataract surgery one intraocular lens (IOL) in each eye, and who had at least one baseline value and one post-baseline value for efficacy.|||LogMAR||Standard Deviation|Mean
1458919|NCT00787150|Secondary|Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
1458920|NCT00787150|Secondary|Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period|The definition of the “Intended Treatment Period” was the period starting on the day of randomization and ending at the later one of either 2 days after the last dose of the study drug or Day 85/Week 12 after the randomization day.|Baseline to Week 12|Full analysis set (FAS) was defined as all randomized participants. Participants were categorized to the group to which they were assigned by the randomization system, regardless of the treatment actually received.|||participants|||Number
1458921|NCT00787150|Secondary|Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period|Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1458922|NCT00787150|Secondary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period|Major bleeding event is acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding is also major bleeding event.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1458923|NCT00787150|Secondary|Number of Participants With Total Bleeding Events During the Treatment Period|Total bleeding events consisted of major (per International Society on Thrombosis and Haemostasis [ISTH] Criteria), clinically relevant non-major and minor bleeding events. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding were classified as minor bleeding.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1458924|NCT00787150|Primary|Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.|Baseline to Week 12|The safety analysis set consisted of all treated participants. Two participants (1 each in the apixaban 2.5 mg BID group and apixaban 5.0 mg BID group) were mistakenly administered warfarin and therefore, included in the warfarin group per the statistical analysis plan.|||participants|||Number
1458925|NCT00787137|Primary|The Number of Episodes of Change From Screening in Laboratory Assessments|Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.|Three months||||Number of episodes of change|||Number
1458926|NCT00787137|Primary|The Number of Episodes of Change in Electrocardiogram|Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.|Three months||||Number of episodes of change|||Number
1458927|NCT00787137|Primary|The Number of Episodes of Change in Vital Signs|Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.|Three months||||Number of episodes of change|||Number
1458928|NCT00787137|Primary|The Percentage of Participants With Adverse Events||Three months|All patients dosed were evaluated|||Percentage of Participants|||Number
1458929|NCT00787137|Primary|The Number of Reported Adverse Events|This was an exploratory study and all safety endpoints were considered.|Three months|All adverse events reported for all patients dosed were evaluated|||Number of adverse events|||Number
1458930|NCT00787124|Primary|SNOHgB Levels|levels were never run by the laboratory|beginning and end of study|||||||
1458931|NCT00787124|Secondary|Oxygen Saturation and Measures of Perfusion Pre and Post-transfusion.|data not appropriately collected for the analysis due to machine malfunctions.|prior to, during, after transfusion|||||||
1458932|NCT00787020|Secondary|Cerebrospinal Fluid (CSF) Output Per Day||14 Days||||Milliliter||95% Confidence Interval|Mean
1458933|NCT00787020|Secondary|External Ventricular Drain (EVD) Complications|External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.|14 Days||||Participants|||Number
1482511|NCT00607243|Primary|Adverse Reactions||0-28 days|||||||
1458935|NCT00786994|Primary|Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.|"Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy.~The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success."|18 weeks||||participants|||Number
1458936|NCT00786916|Primary|Maximal Pain/Discomfort|"FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where 0 represented no pain and 100 (the furthest point to the left) represented the worst pain ever."|during initial 3 minute propofol infusion|All enrolled subjects were randomized into groups A, B or C by hospital pharmacists utilizing a standard prerandomization methodology.|||units on a scale||Standard Deviation|Mean
1458937|NCT00786864|Secondary|Hamstring Flexibility|Standardised hamstring muscle length test. The child was positioned in supine, with the hip flexed at 90 degrees. The knee was then extended passively. The angle of knee extension [from horizontal plane (level to plinth) to fibula] was measured using a digital inclinometer. Continuous data. Scores ranged from -20 (worst score) to 82 (best score).|3 months post-intervention|Intention to treat analysis|||degrees||Standard Deviation|Mean
1458938|NCT00786864|Primary|Low Back Pain Intensity|The visual analogue scale (standardised 100mm, non-hatched line) was used to determine pain intensity. Scores can range between 0 and 10, with the worst possible pain/score = 10 and no pain/best score = 0. Visual analogue scale is continuous.|3 months post-intervention|Intention to treat analysis|||units on a scale||Standard Deviation|Mean
1458939|NCT00786864|Secondary|Neural Mobility|Straight leg raise test was used to measure neural mobility. The amount of hip flexion (angle between the plinth and femur of the raised leg) was measured using a digital inclinometer. Scores ranged between 3 (worst score) and 90.5 (best score). Continuous data.|3 months post-intervention|Intention to treat analysis|||degrees||Standard Deviation|Mean
1458940|NCT00786864|Primary|Low Back Pain Prevalence|All of the children complained of low back pain at baseline. Low back pain prevalence post-intervention was determined by the number of children still complaining of low back pain post-intervention.|3 months post-intervention|Intention to treat analysis|||participants|||Number
1458941|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett’s Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett’s Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||milli seconds||Standard Deviation|Mean
1458942|NCT00786838|Secondary|Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose||Baseline (predose on Day 1) to 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean.|||beats per minute||Standard Deviation|Mean
1458943|NCT00786838|Secondary|Number of Participants With QRS Interval Greater Than 120 Milli Seconds|QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1458944|NCT00786838|Secondary|Number of Participants With PR Interval Greater Than 200 Milli Seconds|PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1458945|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 500 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1458946|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 480 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1458979|NCT00786487|Primary|Insulin Sensitivity as Measured by Hyperinsulinemic Euglycemic Clamp at a Single Time Point (6 Hrs) After Intralipid or Glycerol Infusion|Insulin sensitivity (M value: Glucose infusion rate/kg FFM/min)measured at single time point 6 hours after initiating either intralipid or glycerol infusion)|at 6 hours after starting lipid/glycerol infusion||||M value||Standard Deviation|Mean
1458947|NCT00786838|Secondary|Number of Participants With QTc Interval Greater Than 450 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1458948|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1458949|NCT00786838|Secondary|Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds|The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose) to approximately 24 hour post dose|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||participants|||Number
1458950|NCT00786838|Secondary|Time Taken to Acheive Maximum Plasma Concentration (Tmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||hours||Standard Deviation|Mean
1458951|NCT00786838|Secondary|Maximum Plasma Concentration of Trabectedin (Cmax)||Baseline (predose on Day 2) to 24 hour post dose (Day 2 or Day 3).|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||nanogram per milliliter||Standard Deviation|Mean
1458952|NCT00786838|Primary|The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction|QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.|Baseline (predose on Day 1) to 24 hour post dose (Day 1 or Day 2)|All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.|||milli seconds||Standard Deviation|Mean
1458953|NCT00786799|Secondary|Change in Serum TNFα (Cytokine) Level||Baseline and 1 year||||pg/ml||Standard Deviation|Mean
1458954|NCT00786799|Secondary|Change in Percentage of Serum Omega-3 Fatty Acids|Change in percentage calculated as (100% * ((One Year - Baseline)/Baseline)|Baseline and 1 year||||Percent change of levels of fatty acid||Standard Deviation|Mean
1458955|NCT00786799|Primary|Group-specific and Comparison of Change in Aberrant Behavior Checklist-Hyperactivity Subscale Score (Active Omega-3 Group Only, Placebo Group Only and Comparison Between Groups)|Hyperactivity subscale of Aberrant Behavior checklist (ABC-H): measure of assessing changes in symptoms of hyperactivity in children with autism (survey that was normed on a developmentally delayed population of children and adults and is usually completed by a parent or caregiver. Items are rated on a 4-point scale from “no problem” to “major problem”). ABC-H Subscale Score ranges from 0 (best) to 45 (worst). A negative change signifies improvement.|Baseline and 1 year||||scores on a scale||Standard Deviation|Mean
1458956|NCT00786682|Secondary|Overall Survival||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.||||||
1458957|NCT00786682|Secondary|Time to Disease Progression||10 years|Study was terminated prematurely and insufficient data was collected to assess this outcome measure.||||||
1458958|NCT00786682|Primary|Tumor Response Rate - Primary Endpoint is a 50% Decline in PSA or Normalization of PSA.|We will use a two-stage optimal Simon’s design with a 5% significance level and 80% power to detect an increase in response rate from 50% to 70%. The first stage will enroll 15 patients. If there are 8 or fewer responses among these 15 patients, we will consider the combination therapy to not be worthy of further study, and stop the trial. If we find 9 or more responses, we will proceed to the second stage, and accrual continues for a total of 43 patients. If we see 26 or fewer responses out of 43, then no further investigation of the drug is warranted. If we see 27 or more responses out of 43, then further investigation of the drug will be considered. The “expected” sample size of the trial is 23.5 with the null response rate of 50%.|4 years|Upon reviewing response data for the first 8 patients, we noted that there were no responses thus far. As per the two-stage optimal Simon's design, we would need 8 responses in 15 patients to proceed to stage 2 but we would not have crossed that threshold. The study was stopped due to lack of improved efficacy compared to historical controls.||||||
1458959|NCT00786643|Secondary|Time to Progression|Patients were censored if they did not progress, stopped particiaption due to an adverse event, or withdrew consent following the start of study treatment. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0, Progressive Disease (PD) is defined as a measurable increase in smallest diameter of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of study treatment start until date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 months||||Months||95% Confidence Interval|Median
1462069|NCT00763867|Other Pre-specified|High Sensitivity C-Reactive Protein||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1458960|NCT00786643|Secondary|Early Response Rate (RR) (Stratum 1 Only)|Early RR evaluated in stratum 1 to see if bevacizumab (bev) would be added to GFL treatment (tx). Patients with stable disease (SD) pre 5th cycle of tx had bev added. Response was evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Per RECIST and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; SD, neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD), increase in existing lesions or new lesions.|After 4 cycles of treatment (approximately 56 days)|Prior to the 5th cycle of treatment, early response rate was evaluated in patients in stratum 1 to assess whether bevacizumab would be added to the GFL treatment regimen. Stratum 1 patients with SD at this time point will have bevacizumab added to the regimen. Subjects in stratum 2 were not evaluated for this outcome.|||Participants|||Number
1458961|NCT00786643|Primary|Best Response (BR)|BR is recorded from start of treatment until progressive disease (PD). Imaging was repeated by same technique after every 4 cycles of treatment. Response was evaluated per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.0. Per RECIST v1.0 and CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; PD, increase in existing lesions or new lesions.|After every 4 cycles of treatment (approximately every 56 days for up to about 280 days)|The best response is the best response recorded from the start of treatment until disease progression. Imaging was repeated by same technique after every 4 cycles of treatment. Subjects in both strata were evaluated for this outcome.|||Participants|||Number
1458962|NCT00786565|Secondary|Posterior Capsule Opacification|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|12 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.|||EPCO Score||Standard Deviation|Mean
1458963|NCT00786565|Secondary|Contrast Sensitivity Mesoptic|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1458964|NCT00786565|Secondary|Contrast Sensitivity Mesoptic 1.5 Cpd|The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1458965|NCT00786565|Secondary|Contrast Sensitivity Photopic|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1458966|NCT00786565|Secondary|Contrast Sensitivity Photopic 1.5cpd|The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1458967|NCT00786565|Secondary|Low Contrast Visual Acuity|Uncorrected Low contrast visual acuity - LogMar visual acuity value|1 month|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||LogMar||Standard Deviation|Mean
1458968|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||24 Months|Patients without missing values for best corrected HCVA logmar at pre-operative and post operative at 1 month control.|||LogMar||Standard Deviation|Mean
1458969|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||24 Months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.|||LogMar||Standard Deviation|Mean
1458970|NCT00786565|Primary|Posterior Capsule Opacification Score|Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.|24 months|The EPCO score, evaluated by an independent observer using retro-illumination pictures, all pictures available. Measured in a 3mm and 6mm optic area.|||EPCO Score||Standard Deviation|Mean
1458971|NCT00786565|Primary|Mesoptic Contrast Sensitivity|The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 Months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1458972|NCT00786565|Secondary|High Contrast Visual Acuity||12 months|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
1458973|NCT00786565|Secondary|High Contrast Visual Acuity Best Corrected||3 months|Patients without missing values for BHCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
1458974|NCT00786565|Secondary|High Contrast Visual Acuity Uncorrected||3 months|Patients without missing values for UHCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
1458975|NCT00786565|Secondary|High Contrast Visual Acuity|High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.|1 month|Patients without missing values for HCVA logmar at pre-operative and post operative at 1 month control.|||LogMAR||Standard Deviation|Mean
1458976|NCT00786565|Primary|Photopic Contrast Sensitivity|The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)|3 months|All patients who had cataract surgery and who have at least one baseline value and one post-baseline value for efficacy criteria.|||Log 10||Standard Deviation|Mean
1462765|NCT00759902|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||ng/mL||Standard Deviation|Mean
1458980|NCT00786474|Secondary|Number of Participants With Minor Bleeding|Minor bleeding is defined as symptomatic or clinically-overt bleeding that does not satisfy the criteria for major bleeding|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data|||participants|||Number
1458981|NCT00786474|Secondary|Number of Subjects With Death, Acute Myocardial Infarction, Deep Vein Thrombosis, or Pulmonary Embolism||from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||participants|||Number
1458982|NCT00786474|Primary|Major Bleeding|Major bleeding is defined as symptomatic bleeding associated with transfusion of more than two units of packed red blood cells or whole blood, or death|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||participants|||Number
1458983|NCT00786474|Primary|Number of Arterial Thromboembolic Events|The events are defined as arterial thromboembolism: stokes, transient ischemic attack and systemic embolism events were independently and blindly adjudicated|from subject signing of the consent until completed the study (Day -30 to Day +37)|Of the 1,884 subjects enrolled in the trial, 71 discontinued participation and did not provide outcome data.|||Arterial thromboembolic events|||Number
1458984|NCT00786422|Secondary|Percentage of Participants With Other Vascular Events|All events were adjudicated and confirmed by a central independent adjudication committee. Other vascular events comprised ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), unstable angina (UA), ischemic stroke, transient ischemic attack (TIA), non-central nervous system systemic embolism and vascular death.|Up to 3 months treatment and during subsequent 1 day|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
1458985|NCT00786422|Secondary|Percentage of Participants With Treatment Emergent Deaths - 7 Days Window|Treatment emergent deaths were adjudicated by a central independent adjudication committee. Participants who died from treatment emergent adverse events were counted for this measure.|Up to 3 months treatment and during subsequent 7 days|All participants|||Percentage of participants|||Number
1458986|NCT00786422|Secondary|Percentage of Participants With All Deaths|All deaths were adjudicated by a central independent adjudication committee. Participants who died for any reason were counted for this measure.|Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month|All participants|||Percentage of participants|||Number
1458987|NCT00786422|Secondary|Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment|All events were adjudicated and confirmed by a central independent adjudication committee. The composite efficacy outcome symptomatic recurrent VTE was analyzed descriptively, with the components: Death due to PE, death for which PE cannot be excluded, symptomatic PE and DVT, symptomatic recurrent PE only, and symptomatic recurrent DVT only up to the end of intended treatment period (3 months; 98 study days) and on-treatment (up to 2 days after stop of study drug).|Up to 3 months treatment and during subsequent 30-day observational period for an individual participant|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
1458988|NCT00786422|Primary|Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)|All events were adjudicated and confirmed by a central independent adjudication committee. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.|Up to 3 months treatment and during subsequent 2 days|The safety population consisted of all participants who received at least 1 dose of rivaroxaban.|||Percentage of participants|||Number
1458989|NCT00786422|Primary|Pharmacokinetics – Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmin,ss was predicted for each individual participant from rivaroxaban plasma concentrations and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||µg/L||90% Confidence Interval|Median
1458990|NCT00786422|Primary|Pharmacokinetics – Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban|Cmax,ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||µg/L||90% Confidence Interval|Median
1458991|NCT00786422|Primary|Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban|AUC(0-24)ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inducer.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||(µg*h)/L||90% Confidence Interval|Median
1459268|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with infections|||Number
1458992|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Slope|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out of PT is in seconds. The PT slope describes the linear increase of PT for one unit increase in concentration, thus the unit of PT slope is s*(µg/L)^-1. The final population PK/PD model included a fixed slope that was fitted to the data of the 19 patients that were eligible for evaluation. The estimated mean value (fixed/ the same for all patients in this study) is presented for PT slope.|Up to 3 months treatment|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||s*(µg/L)^-1|||Number
1458993|NCT00786422|Primary|Pharmacodynamics - Prothrombin Time (PT), Baseline Value|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Mean and standard deviation (SD) values are presented for PT baseline.|The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period|The pharmacokinetics/pharmacodynamics (PK/PD) population included all participants who received at least 1 dose of rivaroxaban and had at least 1 valid PK/PD sample after first administration|||Seconds||Standard Deviation|Mean
1458994|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Lupus Anticoagulant Negative to Lupus Anticoagulant Positive)||7 months|17 patients were Lupus anticoagulant negative at entry.|||Participants|||Count of Participants
1458995|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Negative Smith to Positive Smith)||7 months|13 patients were Smith negative at entry.|||Participants|||Count of Participants
1458996|NCT00786409|Secondary|Induction or Increase of Autoantibodies (Conversion From Negative Anti-RNP to Positive Anti-RNP) Anti-RNP||7 months|8 patients were negative for anti-RNP at entry|||Participants|||Count of Participants
1458997|NCT00786409|Primary|SLEDAI Change Score|Systemic Lupus Erythematosus Disease Activity Index (SLEDAI): change from baseline to 7 months. The SLEDAI scale is a weighted sum of 16 clinical and 8 laboratory items. Scores range from 0 to 105 with higher scores indicating worse outcome. The variable analyzed here is the 7 month score minus the baseline score. Therefore negative values indicate an improvement in outcome.|7 months||||units on a scale||95% Confidence Interval|Mean
1458998|NCT00786409|Primary|Anti-HPV 18 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1458999|NCT00786409|Primary|Anti-HPV 18 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1459000|NCT00786409|Primary|Anti-HPV 16 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1459001|NCT00786409|Primary|Anti-HPV 16 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1459002|NCT00786409|Primary|Anti-HPV 11 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1459003|NCT00786409|Primary|Anti-HPV 11 Seroconversion|% Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1459004|NCT00786409|Primary|Anti-HPV 6 GMT|Geometric mean titre in milli-Merck units per ml (mMu/ml)|7 months|4 patients did not have month 7 samples available for analysis|||mMu/ml||95% Confidence Interval|Geometric Mean
1459005|NCT00786409|Primary|Anti-HPV 6 Seroconversion|Percent Seropositive|7 months|4 patients did not have month 7 samples available for analysis|||percentage of participants||95% Confidence Interval|Number
1459006|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on BMI at Week 4 and Week 8|Body Mass Index (BMI) was calculated by using height in centimeters and weight in kilograms.|Week 4 and Week 8||||BMI Kg/m2||Standard Error|Mean
1459007|NCT00786188|Secondary|Proportion of Numerical Rating Scale (NRS) True Responders at Week 4 and Week 8|"The Subject Impression Numerical Rating Scale (NRS) is an 11-point scale was used to measure how bothered a subject was by hot flashes both during the day and the night.~The measure being reported below is percentage of responders who had an improvement in NRS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is define as a score ≤3 on each question."|Week 4 and Week 8||||Percentage of true responders|||Number
1459008|NCT00786188|Secondary|Asses the Effect of Brisdelle (Paroxetine Mesylate) Capsules on the Interference on Sexual Functioning at Week 8|The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The sum of the scores for all 5 items was calculated.|Week 8||||units on a scale||Standard Error|Mean
1459009|NCT00786188|Secondary|Proportion of Clinical Global Impression (CGI) Responders at Week 4 and Week 8|The Clinical Global Impression Scale (CGIS) was completed by the investigator and was used to measure the severity of the VMS at any given time and the improvement from baseline. Responders were defined as subjects who achieved a score of 1 to 3 where 1 = very much improved, 2 = much improved, and 3 = minimally improved. Non-responders were defined as subjects who achieved a score of 4 to 7 where 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 4 and Week 8||||Percentage of participants|||Number
1459021|NCT00786032|Secondary|Time of BCI Impact on the Significant Other and Systems Operator|The quality of life of the significant other, caregiver and system operator will be measured using the Caregiver Burden Assessment at visits. At three month intervals, the significant other, caregiver and system operator will be asked to estimate how much time they spend on the following tasks per day in minutes: BCI System setup ( placing the electrode cap and initiating system operation), BCI System cleanup, and BCI System maintenance (removing cap).|Up to 18 months||||minutes||Standard Deviation|Mean
1459010|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Improvement of Hot Flash Interference at Week 4|"Interference of hot flashes was measured by using the Hot Flash-Related Daily Interference Scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is define as a score ≤3 on each question."|Week 4||||percentage of responders|||Number
1459011|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Mood at Week 4|"Mood was measured using the Profile of Mood States (POMS) Questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 335.~The percentage of participants who had a change from baseline in the total score at Week 4 is reported below."|Week 4||||percentage of participants|||Number
1459012|NCT00786188|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Depression and Anxiety at Week 8|"Depression & anxiety were measured using the Hospital Anxiety & Depression Scale (HADS).~The HADS is a scale developed to assess anxiety & depression. The HADS Scale consists of 14 Questions (7 relating to anxiety; 7 relating to depression) with possible scores ranging from 0 to 21.~The results presented below are the number of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression combined at Week 8."|Week 8||||participants|||Number
1459013|NCT00786188|Secondary|Change From Baseline in Hot Flash Composite Score at Week 4 and Week 8|"A scale was not used for this measurement.~Composite scores of hot flashes were calculated by using the following formula:~CS = (2 • Fm + 3 • Fs)~Where:~CS = composite score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes recorded in the Run-In Period was used to calculate the baseline composite score."|Week 4 and Week 8||||Composite score||Standard Error|Mean
1459014|NCT00786188|Secondary|Change From Baseline in Climacteric Symptoms at Week 8|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject’s total GCS score at baseline and at Week 8 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 8||||units on a scale||Standard Error|Mean
1459015|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 8|"A scale was not used to measure severity scores. Severity scores of hot flashes were calculated for each subject. The following formula was used to calculate severity.~SS = (2•Fm + 3•Fs) ÷ (Fm + Fs)~Where:~SS = severity score Fm = frequency of moderate hot flashes Fs = frequency of severe hot flashes The mean number of moderate and severe hot flashes that was recorded in the Run-In Period was used to calculate the baseline severity score."|Week 4 and Week 8||||Severity score||Standard Error|Mean
1459016|NCT00786188|Primary|Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8|"The number of hot flashes reported in the result table are:~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 8. They are both measured as hot flashes per week."|Week 4 and Week 8|MODIFIED ITT (MITT) POPULATION Brisdelle 49 (98.0%) Placebo 52 (100.0%) PER PROTOCOL (PP) POPULATION Brisdelle 45 (90.0%) Placebo 51(98.1%)|||Hot flashes||Standard Error|Mean
1459017|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by selection rate. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g, THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The number of selections/min for the BCI applications was averaged across users.|Up to 18 months||||number of selection per minute||Standard Deviation|Mean
1459018|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by accuracy. Accuracy rate – The proportion of correct selections made during the daily calibration period of “copy spelling.” Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters, this allows the data to be coded properly (e.g., THE QUICK BROWN FOX JUMPS OVER THE LAZY DOG). Copy spelling data is used for calibration and will be collected at least 2x/week, and may be collected more frequently if unstable performance could be improved by more frequent calibration runs. The independent-use periods of the 14 independent users was totaled by days. Of these days, BCI use was not possible for days (i.e. hiatus days) due to hospitalization, illness, home construction, travel, or BCI system assistant (SA) absence. Over these days, copy-spelling accuracy was averaged.|Up to 18 months||||percentage of days||Standard Deviation|Mean
1459019|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by time per application.|Up to 18 months||||percentage of BCI time||Standard Deviation|Median
1459020|NCT00786032|Secondary|Facility Support Speed of Solution|This study will look at how the technical problems of the BCI are supported by the facility through analyzing the speed of solution.|Up to 18 months||||hours||Standard Deviation|Mean
1459022|NCT00786032|Secondary|BCI Usage by and Impact on the ALS Patient|At three-month intervals, BCI use will be summarized. On a daily basis the BCI will record the total of number of selections made in copy spelling mode. Copy spelling mode is used for system calibration. Participants are expected to indicate that the burden associated with BCI use is inconsequential to the benefit derived from using the BCI. This will be assessed by the McGill Quality of Life (MQOL) at each visit.|Up to 18 months||||units on a scale||Standard Deviation|Mean
1459023|NCT00786032|Primary|BCI System Usage by the ALS Patient|This study will look at the 14 independent users usage of the BCI system. The continued use will be assessed by total time.|Up to 18 months||||days||Standard Deviation|Mean
1459024|NCT00785980|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on 20 subjects out of the 21 subjects who completed the study. One value was determined to be unreliable and was not used.|||ng-hr/mL||Standard Deviation|Mean
1459025|NCT00785980|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.||||ng-hr/mL||Standard Deviation|Mean
1459026|NCT00785980|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for quinine sulfate collected on Days 1 and 11 before dosing and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 and 36 hours post-dose.|Pharmacokinetic analyses are based on twenty-one (21) subjects who successfully completed the study. Three (#3) subjects were dropped by the sponsor due to protocol violation.|||ng/mL||Standard Deviation|Mean
1459027|NCT00785928|Secondary|Number of Participants Experiencing An Adverse Event|Serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.|Baseline up to 24 weeks|All randomized participants who received any amount of blinded study drug.|||Participants|||Count of Participants
1459028|NCT00785928|Secondary|Change From Baseline in Serum Immunoglobulin up to 24 Weeks|Serum immunoglobulin measured by Immunoglobulin G (IgG), Immunoglobulin M (IgM), and Immunoglobulin A (IgA) levels.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||gram per liter (g/L)||Standard Deviation|Mean
1459029|NCT00785928|Secondary|Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks|B-lymphocyte antigen CD20 or CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B-cells. Total B cell counts (CD20+CD3-) are represented by the number of cells per microliter (cells/µL). The reference range is 43 – 602 cells/µL.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||cells per microliter (cells/µL)||Standard Deviation|Mean
1459030|NCT00785928|Secondary|Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks|T1/2,tau is defined as the apparent steady state elimination within the dosing interval. T1/2,tau was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.|24 weeks|The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.|||days|||Number
1459031|NCT00785928|Secondary|Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks|C-trough is defined as the concentration of LY2127399 at the end of the dosing interval after the subcutaneous (sc) injection dosing once every 4 weeks. Mean C-trough value was obtained by conducting a simulation consisting of 1000 participants. The model was then used to predict the concentration-time profile at steady state. The pharmacokinetic (PK) parameters were then estimated from these concentration-time profiles.|24 weeks|The PK analysis population included all intent-to-treat (ITT) participants who received LY2127399 and who had evaluable PK data except 2 participants who were excluded due to Good Clinical Practice (GCP) issues.|||micrograms per milliliter (µg/mL)|||Number
1459032|NCT00785928|Secondary|Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks|A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains. MCS and PCS scores = 0 to 100 (higher scores indicate better health status).|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1459033|NCT00785928|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks|The FACIT Fatigue Scale is a brief participant-reported measure of fatigue and consists of 13 items. Scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1462070|NCT00763867|Other Pre-specified|Endothelin-1||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1459034|NCT00785928|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks|Percent change = [(postbaseline CRP - baseline CRP)/baseline CRP]*100.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percent change||Standard Deviation|Mean
1459035|NCT00785928|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks|Participant's assessment of physical function. Disability section of questionnaire scores participant’s self-perception on degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do) when dressing and grooming, arising, eating, walking, hygiene, reach, grip, and performing other daily activities. Scores for each of the functional areas were averaged to calculate the functional disability index. The HAQ-DI total score, which is the average of the nonmissing functional scores, ranges from 0 (no disability) to 3 (severe disability).|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1459036|NCT00785928|Secondary|Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks|Physician's assessment of disease activity using a visual analog scale (VAS) that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
1459037|NCT00785928|Secondary|Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks|Participant's assessment of disease activity using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
1459038|NCT00785928|Secondary|Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks|Participant's assessment of joint pain using a visual analog scale (VAS), which ranged from 0 to 100 mm, where 0 indicated no pain and 100 indicated worst possible pain.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||millimeters (mm)||Standard Deviation|Mean
1459039|NCT00785928|Secondary|Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks|The EULAR28 categorizes clinical response based upon improvement since baseline in the Disease Activity Score (DAS) modified to include the 28 joint count (DAS28) and post-baseline DAS28 level. DAS28 consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of their disease activity (participant global visual analog scale [VAS]). EULAR28 categories include: No Response (improvement in DAS28 of less than or equal to 0.6 units or post-baseline DAS28 score greater than 5.1 with improvement by less than or equal to 1.2 units), Moderate Response (post-baseline DAS28 score less than or equal to 5.1 with improvement by more than 0.6 units but no greater than 1.2 units or post-baseline DAS28 score greater than 3.2 with improvement by more than 1.2 units), and Good Response (post-baseline DAS28 score less than or equal to 3.2 with improvement by more than 1.2 units).|Up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
1459040|NCT00785928|Secondary|Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks|DAS (modified to include the 28 joint count [DAS28]) consists of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP), and participant global assessment of his or her disease activity (participant global visual analog scale [pt global VAS]). The DAS28 is calculated by using the following formula: DAS28-CRP = 0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014*pt global VAS + 0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||units on a scale||Standard Deviation|Mean
1459041|NCT00785928|Secondary|Change From Baseline in Swollen Joint Count up to 24 Weeks|The number of swollen joints was determined by examination of 28 joints which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||swollen joints||Standard Deviation|Mean
1459055|NCT00785577|Secondary|Time to Response|Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||time (days)|||Number
1467120|NCT00727090|Primary|Change in Serum Sodium From Baseline to 6 Hours||48 hours|Intention to treat|||mMol/L||Standard Deviation|Mean
1459042|NCT00785928|Secondary|Change From Baseline in the Tender Joint Count up to 24 Weeks|Number of tender and painful joints was determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. Joints were assessed by pressure and joint manipulation on physical examination. Participant was asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy.|Baseline, up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||tender joints||Standard Deviation|Mean
1459043|NCT00785928|Secondary|Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks|ACR20 Responder Index is composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR20 Responder is defined as participant with at least 20% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|Up to 24 weeks|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF)/non-responder imputation (NRI). 2 participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
1459044|NCT00785928|Primary|Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with >50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.|Up to week 24|Intent-to-treat (ITT) population included all randomized participants who received any amount of blinded study drug and who had at least 1 post-baseline efficacy assessment, Last Observation Carried Forward (LOCF). Two participants were excluded due to Good Clinical Practice (GCP) issues.|||percentage of participants|||Number
1459045|NCT00785798|Primary|Number of Subjects With Stable Disease (SD)||2 years||||participants|||Number
1459046|NCT00785798|Primary|Number of Subjects With Progressive Disease (PR)||2 years||||participants|||Number
1459047|NCT00785785|Primary|Time to Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|up to month 37|Full Analysis Set (FAS) consists of all randomized patients for the Core Phase.|||months||Full Range|Median
1459048|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration|Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||Ratio|||Number
1459049|NCT00785772|Primary|Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model|Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||Ratio|||Number
1459050|NCT00785772|Primary|Observed Plasma Gabapentin Concentration|Plasma gabapentin concentrations were measured on Day 8 and Day 15|Days 8 and 15|The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.|||µg/mL||Full Range|Mean
1459051|NCT00785707|Secondary|Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.|24 months||||units on a scale||Full Range|Mean
1459052|NCT00785707|Primary|To Validate the LittleEARS Auditory Questionnaire|The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.|24 months||||units on a scale||Full Range|Mean
1459053|NCT00785629|Primary|Serum Phosphorus|mean serum phosphorus from months 3-9|months 3-9|ITT analysis was ALL active patients combined versus all placebo patients combined|||mg/dL||Standard Deviation|Mean
1459054|NCT00785577|Secondary|Number of Participants With Neurological Treatment Emergent Adverse Events (TEAEs)|"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
1459136|NCT00784784|Primary|Number of Laboratory Confirmed Influenza Infections|Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)|6 months|intention to treat|||infections|||Number
1462783|NCT00759759|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
1459056|NCT00785577|Secondary|Pharmacokinetic (PK) Parameter: Clearance of LY545694 (CLp) and Compound 645838 (CLm)|Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported.|Baseline through 5 weeks|The PK dataset for population modeling consisted of quantifiable plasma LY545694 and Compound 64538 concentrations from participants following daily oral doses of LY545694 21 mg to LY545694 105 mg.|||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
1459057|NCT00785577|Secondary|Number of Participants Reporting Blurry or Hazy Vision Using the Subjective Vision Inventory (SVI) Question 1 (Q1) at 5 Weeks|This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.|||participants|||Number
1459058|NCT00785577|Secondary|Number of Participants With Suicidal Behaviors and Ideations|"The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a yes answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation."|Baseline through week 5|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||participants|||Number
1459059|NCT00785577|Secondary|Change From Baseline in Overall Total Quick Inventory of Depressive Symptomatology (QIDS) Score|The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459060|NCT00785577|Secondary|Percentage of Participants With Reported Hypoglycemic Events|"Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the Investigations system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||percentage of participants|||Number
1459061|NCT00785577|Secondary|Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas|The number of participants having QTcF and QTcB change ≥ 30 msec was summarized.|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||participants|||Number
1459062|NCT00785577|Secondary|Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks|Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1459063|NCT00785577|Secondary|Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks|Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1459064|NCT00785577|Secondary|Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values|"The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module."|Baseline through 5 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
1459065|NCT00785577|Secondary|Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase|Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module.|Baseline through 6 weeks|The safety analysis population included all 273 participants randomized to study drug.|||participants|||Number
1459066|NCT00785577|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks|The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459137|NCT00784784|Secondary|Number of Subjects Adhering to Long-term Zanamivir Prophylaxis|Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).|5 months|ITT|||participants||95% Confidence Interval|Number
1459067|NCT00785577|Secondary|Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score|The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459068|NCT00785577|Secondary|Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks|The SF-36 Health Status Survey was a generic, health-related scale assessing participants’ quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459069|NCT00785577|Secondary|Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks|NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5‑point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3‑point bothersome/importance scale (1=none to 3=very).|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459070|NCT00785577|Secondary|Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks|ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459071|NCT00785577|Secondary|Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks|SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459072|NCT00785577|Secondary|Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks|PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Week 5|The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected.|||units on a scale||Standard Error|Least Squares Mean
1459073|NCT00785577|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks|CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459074|NCT00785577|Secondary|Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks|BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459075|NCT00785577|Secondary|Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks|Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459076|NCT00785577|Secondary|Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score|This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).|Baseline through 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population.|||participants|||Number
1459077|NCT00785577|Secondary|Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks|This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459078|NCT00785577|Secondary|Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks|This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure.|||units on a scale||Standard Error|Least Squares Mean
1459079|NCT00785577|Primary|Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks|This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction.|Baseline, 5 weeks|The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population.|||units on a scale||Standard Error|Least Squares Mean
1459080|NCT00785512|Secondary|Trough Sitting Systolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)||||mm HG||Standard Deviation|Mean
1459081|NCT00785512|Primary|Trough Sitting Diastolic Blood Pressure|Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.|From baseline, week 0 (Visit 9) to week 4 (Visit 12)||||mm HG||Standard Deviation|Mean
1459082|NCT00785486|Primary|The Area Under the the Concentration Time Curve From Zero to Tau (0-8hrs) for Qualaquin (Quinine) AUC Tau Before and After Midazolam|Qualaquin (quinine) - AUC tau alone at steady state (day 9) and in the presence of coadministered midazolam 2 mg (day 10) over the dosing interval (0 – 8 hours), as calculated by the linear trapezoidal method.|Days 9 and 10 at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 7.917 hours|per protocol|||ng•h/mL||Standard Deviation|Mean
1459083|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to Infinity (AUC Inf) for Midazolam and 1 Hydroxy Midazolam Before (Day 1) and After (Day 10) Qualaquin (Quinine).|AUC inf for Midazolam and hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with steady state Qualaquin(quinine)- the sum of AUC0-t plus the ratio of the last measured plasma concentration to the elimination rate constant to determine whether a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|per protocol|||ng·h/mL||Standard Deviation|Mean
1459084|NCT00785486|Primary|Area Under the Concentration Time Curve From Zero to T (AUC 0-t) for Midazolam and 1-hydroxy Midazolam at Baseline and With Qualaquin (Quinine) at Steady State.|Area under the concentration time curve(AUC 0-t) calculated by the linear trapezoidal method from time 0 to 24 hours, for Midazolam and 1-hydroxy-midazolam on day 1 (midazolam alone) and day 10 (midazolam with Qualaquin -(quinine) at steady state to determine if a significant drug interaction occurs between midazolam and quinine|Days 1 and 10 at 0.167, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 7.917, 12, 15 and 24 hours|by protocol|||ng•h/mL||Standard Deviation|Mean
1459085|NCT00785486|Primary|Maximum Serum Concentration (Cmax)|Maximum serum concentration(Cmax)|Day 1 (Midazolam Alone), Day 9 (Qualaquin (quinine) Alone), Day 10 Midazolam with Qualaquin (quinine)|per protocol|||ng/ml||Standard Deviation|Mean
1459086|NCT00785356|Primary|The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.||3 months|||||||
1459087|NCT00785291|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization to death or last follow-up (up to 5 years)||||months||95% Confidence Interval|Median
1459088|NCT00785291|Secondary|12 Month Progression Free Survival|Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|12 months|Participants who never began protocol treatment were excluded.|||percentage of participants||95% Confidence Interval|Number
1459089|NCT00785291|Secondary|Time to Treatment Failure|Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.|Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)|Participants who never began protocol treatment were excluded.|||months||95% Confidence Interval|Median
1459090|NCT00785291|Secondary|Objective Tumor Response Rate|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).|Up to 5 years||||percentage of participants|||Number
1491269|NCT00538642|Secondary|Systolic Blood Pressure||Baseline||||mm Hg||Standard Deviation|Mean
1459091|NCT00785291|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).|Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)|Participants who never began protocol treatment were excluded.|||months||95% Confidence Interval|Median
1459092|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug-hr/mL||Standard Deviation|Mean
1459093|NCT00785213|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for rosiglitazone.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug-hr/mL||Standard Deviation|Mean
1459094|NCT00785213|Primary|Maximum Plasma Concentration (Cmax) of Rosiglitazone|The maximum or peak concentration that rosiglitazone reaches in the plasma.|serial pharmacokinetic blood samples drawn prior to dosing on Days 1 and 7 and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 20 and 24 hours after dose administration.|Twenty Three (23) subjects were enrolled in this study. Five (5) subjects withdrew from the study. Pharmacokinetic analyses are based upon data obtained from the eighteen (18) subjects that completed the study.|||ug/mL||Standard Deviation|Mean
1459095|NCT00785044|Primary|Numerical Heart to Mediastinum (H/M) Ratio at 3 Hours 50 Minutes Post-administration on Planar 123I-mIBG Imaging by Adverse Cardiac Events (ACEs) Status|The numerical value of 123 I-mIBG uptake (H/M ratio) at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. Receiver operator characteristic curves (ROC) constructed on the basis of sensitivity and specificity to identify ACEs across all H/M values were used to calculate the area under the ROC curve (AUC). The AUC was used to test for statistical significance of the prognostic usefulness of the H/M ratio. In the present MBG313 study, additional efficacy data is provided for 471 participants and new data from MBG313 were combined with data collected in MBG311 and MBG312 for efficacy analysis.|From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 24 months|Efficacy population was 961 participants who received IMP and had a consensus H/M ratio on 3 hour 50 minute planar image in MBG 311 or MBG 312. Here, number of participant analyzed = number of participants with available data for this endpoint.|||Ratio||Standard Deviation|Mean
1459096|NCT00784979|Secondary|Monitor Patient Survival||5 years|||||||
1459097|NCT00784979|Secondary|Monitor Graft Survival||5 years|||||||
1459098|NCT00784979|Primary|The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor|The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.|four weeks||||percent of subjects becoming compatible|||Number
1459099|NCT00784927|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.||||months||95% Confidence Interval|Median
1459100|NCT00784927|Secondary|Progression-free Survival Time|"Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death.~Progressive disease is defined as having one of the following:~The appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.~At least a 50% increase from nadir in the sum of the product of the dimension (SPD) of any previously involved nodes.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Up to 1 year from registration.||||months||95% Confidence Interval|Median
1459101|NCT00784927|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 1 year from registration.||||months||95% Confidence Interval|Median
1459102|NCT00784927|Secondary|Tumor Response to Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone in the Subgroup of Patients With Lymphoplasmacytic Lymphoma (Waldenstrom’s Macroglobulinemia).|"The proportion of responses in Waldenstrom's macroglobulinemia was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.||||percentage of participants||95% Confidence Interval|Number
1459103|NCT00784927|Primary|Assessment of Tumor Response|"The proportion of responses was determined by counting the number of complete responses and partial responses and dividing by the number of evaluable patients.~Complete Response (CR): Disappearance of all evidence of disease and disease-related symptoms. The spleen and/or liver, if considered enlarged before therapy on the basis of a physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear. If the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~Partial Response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase should be observed in the size of other nodes, liver, or spleen. No new sites of disease should be observed."|Up to 1 year from registration.||||percentage of participants||95% Confidence Interval|Number
1459104|NCT00784875|Secondary|Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||milliseconds||Standard Error|Least Squares Mean
1459105|NCT00784875|Secondary|Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||beats per minute||Standard Error|Least Squares Mean
1459106|NCT00784875|Secondary|Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint|Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).|2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.|||participants|||Number
1459107|NCT00784875|Secondary|Change From Baseline in Weight at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||kilogram||Standard Error|Least Squares Mean
1459108|NCT00784875|Secondary|Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||beats per minute||Standard Error|Least Squares Mean
1459109|NCT00784875|Secondary|Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint|Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.|Baseline, 2 weeks of treatment over 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||mmHg||Standard Error|Least Squares Mean
1459110|NCT00784875|Secondary|Number of Participants With Serious Adverse Events (SAEs)|SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.|||participants|||Number
1459111|NCT00784875|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.|Baseline through 8 weeks|All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.|||participants|||Number
1459112|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group|Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline through 8 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.|||participants||Standard Error|Least Squares Mean
1459113|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.|Baseline, 2 weeks|Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.|||minutes||Standard Error|Least Squares Mean
1459114|NCT00784875|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type|Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline through 8 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.|||participants|||Number
1491270|NCT00538642|Secondary|Abdominal Circumference||4-5 months||||cm||Standard Deviation|Mean
1459115|NCT00784875|Secondary|Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.|Baseline, 2 weeks|Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.|||minutes||Standard Error|Least Squares Mean
1459116|NCT00784875|Secondary|Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
1459117|NCT00784875|Secondary|Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint|Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.|2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
1459118|NCT00784875|Secondary|Treatment Satisfaction as Measured by the Participant Drug Preference Question|After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.|Baseline (Period A) and 2 weeks (Period B)|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||percentage of participants|||Number
1459119|NCT00784875|Secondary|Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint|The EuroQoL Questionnaire–5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1459120|NCT00784875|Secondary|Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint|The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary)|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1459121|NCT00784875|Secondary|Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint|The ISI is a brief self-report instrument that measures a participant’s perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1459122|NCT00784875|Secondary|Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint|DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1459123|NCT00784875|Secondary|Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint|Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||units on a scale||Standard Error|Least Squares Mean
1459124|NCT00784875|Secondary|Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint|Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||ratio||Standard Error|Least Squares Mean
1462071|NCT00763867|Other Pre-specified|Procollagen III N-terminal Peptide||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1459125|NCT00784875|Secondary|Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint|Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
1459126|NCT00784875|Secondary|Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint|Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||number of awakenings||Standard Error|Least Squares Mean
1459127|NCT00784875|Secondary|Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint|Unwanted time awake (minutes awake [MA] before sleep [between turning off the lights to first falling asleep], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
1459128|NCT00784875|Primary|Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint|Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (<65 or ≥65), and insomnia type (primary vs. secondary).|Baseline, 2 weeks|All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.|||minutes||Standard Error|Least Squares Mean
1459129|NCT00784849|Secondary|Superficial Skin Necrosis|the number of participants who developed post-operative skin necrosis within 2 weeks of surgery|2 weeks postoperatively||||participants|||Number
1459130|NCT00784849|Secondary|Safety (Allergic Reaction to Blue Dye)|number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension|intraoperatively up to 6 hours||||participants|||Number
1459131|NCT00784849|Primary|The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)||intraoperatively; up to 6 hours||||participants|||Number
1459132|NCT00784836|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Planned for up to 18 months plus 30 days; actual study duration was 111 days.||||participants|||Number
1459133|NCT00784836|Primary|Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)|The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.|assessed every 3 months up to 18 months|The study was terminated early before any of the 3 enrolled subjects completed the study; therefore, no statistical analysis was performed.||||||
1459134|NCT00784810|Secondary|Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.|"To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the number of intakes of rescue medication for this period (ie between Visit 8 and Visit 9)."|Between visit 8 and 9|The number of participants for analysis is less due to subject withdrawals or lack of data.|||Number of rescue medication intakes||Standard Deviation|Mean
1459135|NCT00784810|Primary|Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)|The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)|Average daily pain over last 24 hours (at Week 12)|To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data.|||Units on a BS-11 scale at Week 12||Standard Deviation|Mean
1491271|NCT00538642|Secondary|Abdominal Circumference||Baseline||||cm||Standard Deviation|Mean
1459138|NCT00784719|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8|NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||Units on a scale||Standard Deviation|Mean
1459139|NCT00784719|Secondary|Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8|mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|Data for mOCI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.||||||
1459140|NCT00784719|Secondary|Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).|Baseline, Week 1, 2, 4, 6, 8|Data for OSDI raw score was not analyzed due to the exploratory nature and overwhelming amount of data derived from the analysis.||||||
1459141|NCT00784719|Secondary|Percentage of Participants With >= 10 Units Decrease in Total OSDI Score|OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1459142|NCT00784719|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8|OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 [Q1]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here ‘N’ (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1459143|NCT00784719|Secondary|Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8|Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||drops/day||Standard Deviation|Mean
1459144|NCT00784719|Secondary|Percentage of Participants With >= 5 Units Decrease in Total OCI Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1459145|NCT00784719|Secondary|Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1459146|NCT00784719|Secondary|Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8|TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||seconds||Standard Deviation|Mean
1459166|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The WFIRS-P Global Score at Endpoint of The Randomized Withdrawal Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
1491272|NCT00538642|Secondary|Body Mass Index||4-5 months||||Kg/m2||Standard Deviation|Mean
1459147|NCT00784719|Secondary|Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8|Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1459148|NCT00784719|Secondary|Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining|Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1459149|NCT00784719|Secondary|Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8|Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||units on a scale||Standard Deviation|Mean
1459150|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1459151|NCT00784719|Secondary|Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 1, 2, 4, 6|ITT population included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||percentage of participants|||Number
1459152|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8|Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||mm||Standard Deviation|Mean
1459153|NCT00784719|Secondary|Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline, Week 1, 2, 4, 6, 8|ITT population included all enrolled participants who received at least 1 dose of study medication. LOCF method was used for imputing missing data at Week 8. Here, 'n' signifies those participants who were evaluable for this measure at given time point for each group respectively.|||mm||Standard Deviation|Mean
1459154|NCT00784719|Secondary|Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score|OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1460261|NCT00776230|Primary|Primary: 1. Geometric Mean Titers (GMT) at Day 56||56 days post 1st vaccination|Intention To Treat Population, i.e., all subjects entered into the study who received at least one dose of study medication|||Geometric Mean Titer - Estimate||95% Confidence Interval|Geometric Mean
1459155|NCT00784719|Secondary|Time to Achieve 100 Percent (%) Clearance of Corneal Staining|Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1459156|NCT00784719|Secondary|Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Baseline through Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||days||95% Confidence Interval|Median
1459157|NCT00784719|Primary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8|Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the ‘worse eye’, defined as the eye with worse Schirmer test score without anesthesia score at baseline.|Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) was the method used for imputing missing data at Week 8.|||percentage of participants|||Number
1459158|NCT00784719|Primary|Percentage of Participants With Ocular Tolerability Assessment|Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes [<5 min] after application) or persistent (if continued beyond 5 minutes [>=5 min] after application).|Baseline up to Week 8|ITT population included all enrolled participants who received at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
1459159|NCT00784719|Primary|Percentage of Participants With Ocular Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.|Baseline up to Week 8|ITT population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1459160|NCT00784719|Primary|Percentage of Participants With Systemic Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.|Baseline up to Week 8|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1459161|NCT00784654|Other Pre-specified|C-SSRS During the Randomized Withdrawal Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Baseline of the randomized withdrawal period to end of the study (Up to 6 weeks)|Randomized Safety Population|||participants|||Number
1459162|NCT00784654|Other Pre-specified|Columbia-Suicide Severity Rating Scale (C-SSRS) During The Open-label Period|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|From open-label baseline to Week-26|Open-label Safety Population|||participants|||Number
1459163|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Randomized Withdrawal Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Randomized withdrawal baseline|Randomized FAS|||percentage of participants|||Number
1459164|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in BPRS-C Total Score at Endpoint of The Randomized Withdrawal Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Safety Population includes all subjects who received at least 1 dose of any investigational product during the Randomized Withdrawal Period|||Scores on a scale||Standard Deviation|Mean
1459165|NCT00784654|Secondary|Change From Open-Label Baseline in The Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Endpoint (Week-26) of The Open-label Period|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label Safety Population includes all subjects who received at least 1 dose of investigational product in the Open-label period.|||Scores on a scale||Standard Deviation|Mean
1459236|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <200 Copies/mL at Week 24|This measure was assessed in the same manner as the primary efficacy analysis for the proportion of patients achieving HIV-1 RNA levels below 200 copies/mL at Week 24 of the study.|Week 24||||percentage of patients|||Number
1491273|NCT00538642|Secondary|Body Mass Index||Baseline||||Kg/m2||Standard Deviation|Mean
1459167|NCT00784654|Secondary|Change From Open-Label Baseline in The Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Endpoint (Week-26) of The Open-label Period|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||scores on a scale||Standard Deviation|Mean
1459168|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The CHIP-CE:PRF Global T-score at Endpoint of The Randomized Withdrawal Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||T-scores||Standard Error|Least Squares Mean
1459169|NCT00784654|Secondary|Change From Open-label Baseline in The Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at Endpoint (Week-26) of The Open-label Period|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||T-scores||Standard Deviation|Mean
1459170|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The HUI-2 Scores at Endpoint of The Randomized Withdrawal Period|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Deviation|Mean
1459171|NCT00784654|Secondary|Change From Open-label Baseline in The Health Utilities Index-2 (HUI-2) Scores at Endpoint (Week-26) of The Open-label Period, LOCF|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|At open-label baseline and endpoint (Week-26) of the open-label period|Open-label FAS|||scores on a scale||Standard Deviation|Mean
1459172|NCT00784654|Secondary|Percent of Participants With Improvement on Clinical Global Impression - Improvement (CGI-I) at Endpoint (Week-26) of The Open-label Period|"Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.~Improvement includes CGI-I categories of very much improved and much improved. No improvement includes all other assessed categories."|At Week 26|Open-label FAS|||percentage of improved participants|||Number
1459173|NCT00784654|Secondary|Percent of Participants With CGI-S at Endpoint of The Randomized Withdrawal Period, Last Observation Carried Forward (LOCF)|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At endpoint of the randomized withdrawal period (Up to 6 weeks)|Randomized FAS|||percentage of participants|||Number
1459174|NCT00784654|Other Pre-specified|Percent of Participants With CGI-S at Open-label Baseline|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Open-label baseline|Open-label FAS|||percentage of participants|||Number
1459175|NCT00784654|Secondary|Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Endpoint (Week-26) of The Open-label Period|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|At Week 26|Open-label FAS|||percentage of participants|||Number
1459176|NCT00784654|Secondary|Change From Randomized Withdrawal Baseline in The ADHD-RS-IV Total Score at Endpoint of The Randomized Withdrawal Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized FAS|||Scores on a scale||Standard Error|Least Squares Mean
1459177|NCT00784654|Secondary|Change From Open-Label Baseline in The Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at Endpoint (Week-26) of The Open-label Period|ADHD-RS-IV consists of 18 items scored on a 4-point scale from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Open-label baseline and Endpoint (Week-26)|Open-label Full Analysis set (Open-label FAS) includes all subjects who received at least 1 dose of investigational product during the Open-label Period.|||Scores on a scale||Standard Deviation|Mean
1459178|NCT00784654|Primary|Percent of Participants With Treatment Failures at End of The Randomized Withdrawal Period|"Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and >= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period.~Subjects without an endpoint value were classed as treatment failures."|Baseline of the randomized withdrawal period and its relevant endpoint (Up to 6 weeks)|Randomized Full Analysis Set (Randomized FAS) includes all subjects who were randomized and received at least 1 dose of investigational product during the Randomized Withdrawal Period.|||percentage of participants|||Number
1459179|NCT00784563|Other Pre-specified|Change in LEDD (Levodopa Equivalent Daily Dose)|=amount after 6 months training - amount at baseline Total antiparkinsonian treatment daily dose expressed in levodopa equivalents per Tomlinson et al (PMID:21069833). Higher scores are worse.|6 months||||mg/day||Standard Deviation|Mean
1460308|NCT00775593|Primary|Complete Response Rate||At 2 years from study entry||||participants|||Number
1499042|NCT00479258|Secondary|Hypoglycemic Event Rates;||12 months|||||||
1459180|NCT00784563|Secondary|Change in Percent Increase Score (PIS) on Eriksen's Flanker Task|performance on the Eriksen's flanker task (see PMID: 24991037). Participants were asked to identify the orientation of a central arrow cue (‘<’ or ‘>’), which was flanked on both sides by two arrow cues that either pointed in the same direction (congruent: <<<<<) or a different direction (incongruent: >><>>). Using reaction times (RT) during congruent and incongruent trials, the PIS was calculated as =((RT_incongruent – RT_congruent) / RT_congruent) * 100. Higher PIS is worse.|6 months||||Percentage of Increase score||Standard Deviation|Mean
1459181|NCT00784563|Secondary|Change in the MOCA Score|=Score after 6 months training - baseline score. MOCA=Montreal Cognitive Training Assessment Scores range 0-30, higher is better.|6 months||||units on a scale||Standard Deviation|Mean
1459182|NCT00784563|Secondary|Change in the Total UPDRS Score|"=Score after 6 months training - baseline score The total UPDRS score is calculated by adding Section I, Section II, and Section III scores (below). Higher scores are worse. The score ranges 0-176.~Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108."|6 months||||units on a scale||Standard Deviation|Mean
1459183|NCT00784563|Secondary|Change in the UPDRS Section III Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1459184|NCT00784563|Other Pre-specified|Change in Parkinson’s Disease Quality of Life Scale (PDQUALIF) Score|= PDQUALIF score after 6 months training - baseline score The PDQUALIF is a 32 item questionnaire resulting in 7 factors. . Subjects rate themselves between 1 (most favorable) and 5 (least favorable) on a Likert scale. Factor scores are standardized to100 and lower scores are better. The outcome measure is the average of these 7 factor scores.|6 months||||units on a scale||Standard Deviation|Mean
1459185|NCT00784563|Other Pre-specified|Change in Geriatric Depression Scale Score|=Score after 6 months training - score at baseline. The Geriatric Depression Scale (GDS)-short form is a 15 item yes/no questionnaire. The range is 0-15 and scores >5 suggest depression. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1459186|NCT00784563|Other Pre-specified|Change in Fatigue Severity Scale Score|=Score after 6 months of training - baseline score. The Fatigue Severity Scale (FSS) is a self-administered unidimensional generic 9-item fatigue rating scale. These are rated on a seven-grade Likert scale of which only the respective ends are defined (‘‘completely disagree’’=1 to ‘‘completely agree’’=7). The total FSS score represents the mean score of each of the nine items, yielding a score range between 1 and 7, higher scores indicating a higher level of fatigue.|6 months||||units on a scale||Standard Deviation|Mean
1459187|NCT00784563|Secondary|Change in UPDRS Section II Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1459188|NCT00784563|Secondary|Change in the UPDRS Section I Score|=Score after 6 months training - baseline score Unified Parkinson’s Disease Rating Scale (UPDRS) is an ordinal scale with all items scored from 0=normal function to 4=very severely disabled. It has 3 sections: I) Mental, Behavior, and Mood: Comprises four questions on intellectual impairment, thought disorder, depression, and apathy (scores range 0-16). II) The Activities of Daily Living (ADL) subscale is based on interview and comprises 13 items (scores range 0-52). III) UPDRS motor section is based on physical examination evaluates the components of parkinsonism (tremor, rigidity, bradykinesia, gait/posture). There are 27 items resulting in a maximum score of 108. Higher scores are worse.|6 months||||units on a scale||Standard Deviation|Mean
1459189|NCT00784563|Secondary|Change in 7 Meter Walk Time|Time complete the 7 m Walk test after 6 months aerobic training - Time complete the 7 m Walk test at baseline|6 months|See PMID: 24991037|||seconds||Standard Deviation|Mean
1459190|NCT00784563|Primary|Change in Aerobic Fitness|"VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting).~Please see publication PMID: 24991037 for details."|6 months|Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for all analyses.|||ml/min/kg||Standard Deviation|Mean
1459191|NCT00784550|Secondary|Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint|The CRQ-SAS measures 4 domains of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately.|Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire)|ITT Population|||points on a scale||Standard Error|Mean
1460470|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Haemoglobin)|||percentage of patients|||Number
1459192|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose IC for each participant) value minus the baseline value. IC is defined as the amount of air that can be inhaled after a normal expiration. IC is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant)|ITT Population|||ml||Standard Error|Mean
1459193|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FVC for each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration (FVC).|Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant)|ITT Population|||ml||Standard Error|Mean
1459194|NCT00784550|Secondary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FVC fore each participant) value minus the baseline value. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration.|Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant)|ITT Population|||ml||Standard Error|Mean
1459195|NCT00784550|Secondary|Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of 2 hour post-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant)|ITT Population|||ml||Standard Error|Mean
1459196|NCT00784550|Primary|Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint|Change from baseline was calculated as the Endpoint (defined as the last recorded measure of AM pre-dose FEV1 for each participant) value minus the baseline value. FEV1 is defined as the amount of air expelled from the lungs in one second after a full inspiration and is a measure of pulmonary function.|Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant)|Intent-to-Treat (ITT) Population: all participants randomized to study drug|||milliliters (ml)||Standard Error|Mean
1459197|NCT00784459|Primary|Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept||3 months||||percentage of cells||Standard Deviation|Mean
1459198|NCT00784459|Primary|Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge|collected prior to randomization to abatacept or placebo|baseline||||percentage of cells||Standard Deviation|Mean
1459199|NCT00784368|Secondary|Number of Participants With Change in the Endoscopy or Image Diagnosis by Diagnosis Name (Centralized Assessment)|Level of Improvement in Endoscopy was assessed as disappeared, decreased, improved, no change, worsened and could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1459200|NCT00784368|Secondary|Number of Participants With Change In the Endoscopy or Image Diagnosis By Centralized Assessment|Level of Improvement in the Endoscopy or Image diagnosis was assessed as disappeared (if the abnormal findings were normalized), decreased (if level of pathogenic fungus was decreased in culture), improved (if significant improvement was observed in the abnormal findings), no change (if no significant improvement was observed in the abnormal findings), worsened (if the abnormal findings were worsened) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1459201|NCT00784368|Secondary|Number of Participants With Serologic Effect Against Fungi by Diagnosis Name (Centralized Assessment)|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), worsened (if the test values increased) and could not be assessed (if it was difficult to make above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1459202|NCT00784368|Secondary|Number of Participants With Serological Effect Against Fungi by Centralized Assessment|Serological effect against fungi was assessed as changed to negative (if the test values became negative), improved (if the test values decreased), no change (if there was no change in the test values), no change (if there was no change in the test values) , worsened (if the test values increased) and could not be assessed (if it was difficult to make the above-noted assessments due to a reason such as a lack of detection in the tests before and after dosing).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1459203|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Diagnosis Name (Centralized Assessment)|Mycological efficacy was assessed as disappeared, decreased, no change, increased, could not be assessed. The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, C.N.P.A, P.A. and P.C.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1459204|NCT00784368|Secondary|Number of Participants With Mycological Efficacy by Centralized Assessment|Mycological efficacy was assessed as disappeared (if results for pathogenic fungus became negative, or if it was not possible to obtain the appropriate specimens), decreased (if level of pathogenic fungus was decreased in culture), no change (if there was no quantitative change in pathogenic fungus), increased (if there was a quantitative increase in pathogenic fungus, if results for pathogenic fungus became positive after start of dosing or if new pathogenic fungus was identified) , could not be assessed (if it was difficult to make the above assessment due to lack of detection in tests).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1459205|NCT00784368|Secondary|Percentage of Participants With Overall Response by Diagnosis Name (Centralized Assessment)|E.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and number of cases for whom treatment was judged to be ineffective multiplied by 100. T.S.R. was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, number of cases for whom treatment was judged to be ineffective and number of cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||percentage of participants||95% Confidence Interval|Number
1459206|NCT00784368|Secondary|Percentage of Participants With Overall Response by Centralized Assessment|Efficacy rate (E.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective and cases for whom treatment was judged to be ineffective multiplied by 100. Treatment success rate (T.S.R.) was calculated as number of cases for whom treatment was judged to be effective divided by sum of number of cases for whom treatment was judged to be effective, cases for whom treatment was judged to be ineffective and cases for whom the efficacy could not be assessed multiplied by 100.|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|The FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
1459207|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Diagnosis Name (Centralized Assessment)|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments). The cases evaluated were candidemia, esophageal candidiasis, invasive aspergillosis, chronic necrotic pulmonary aspergillosis (C.N.P.A), pulmonary aspergilloma (P.A.) and pulmonary cryptococcosis (P.C).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI Switched treatment)|The FAS population. As per planned analysis both SFI arms were combined for efficacy analyses; participants with FN with suspected fungal infection were not planned to be analyzed for this outcome measure. Here, 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||participants|||Number
1459208|NCT00784368|Secondary|Number of Participants With Change in Clinical Symptoms by Centralized Assessment|Level of improvement in the clinical symptoms was assessed as: disappeared (if clinical symptoms disappeared), improved (significant improvement in clinical symptoms ), no change (almost no improvement in the clinical symptoms), worsened (if the clinical symptoms worsened) and could not be assessed (if it was difficult to make the above-noted assessments).|Baseline up to end of treatment (Day 85 for SFI [ITCZ Oral Solution Monotherapy] and Day 99 for SFI and FN Switched treatment)|FAS population included all participants except those who did not meet main eligibility criteria, who did not receive ITCZ-IV or ITCZ-OS and participants without efficacy data. As per planned analysis both SFI (ITCZ Oral Solution Monotherapy) and SFI (Switched Treatment) arms were combined for all efficacy analyses.|||participants|||Number
1459209|NCT00784368|Primary|Time Above Minimum Inhibitory Concentration (T>MIC)|The T>MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||percent time||Standard Deviation|Mean
1459237|NCT00784147|Primary|The Proportion of Patients Achieving Undetectable Viral Loads at Week 24.|"For the primary efficacy analysis, undetectable was defined as having HIV-1 RNA below the limit of assay detection at <50 copies/mL. The primary efficacy endpoint was analyzed using Fisher exact test. The primary analysis was performed using the ITT population and both the missing data equals treatment failure (MEF) and last observation carried forward (LOCF) methods. The more conservative MEF results are recorded here."|24 weeks||||percentage of participants|||Number
1459210|NCT00784368|Primary|Area Under the Curve During 24 Hours by Minimum Inhibitory Concentration (AUC 0-24/MIC)|The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||hour||Standard Deviation|Mean
1459211|NCT00784368|Primary|Maximum Plasma Drug Concentration by Minimum Inhibitory Concentration (Cmax/MIC)|The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||ratio||Standard Deviation|Mean
1459212|NCT00784368|Primary|Minimum Inhibitory Concentration (MIC)|The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively. MIC was not obtained for FN (Switched treatment) and hence the data not given for the same.|||mcg per ml||Standard Deviation|Mean
1459213|NCT00784368|Primary|Area Under the Curve From Time Zero to 24 Hours Post-dose Observed Plasma Itraconazole Concentration (AUC[0-24])|The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg*hour(hr) per ml.|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|The PK analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population, for SFI (ITCZ-OS). Here 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||mcg*hr per ml||Standard Deviation|Mean
1459214|NCT00784368|Primary|Maximum Plasma Itraconazole Concentration (Cmax)|The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).|Day 85 for SFI (ITCZ Oral Solution Monotherapy); and Day 99 for SFI and FN Switched treatment|Pharmacokinetic (PK) analysis set included all participants who received ITCZ-OS and had plasma concentration data. One participant without any infection evidence was also included in the PK population for SFI (ITCZ-OS). 'n' signifies those participants who were evaluated for this measure at specified time points for each arm group respectively.|||mcg/ml||Standard Deviation|Mean
1459215|NCT00784277|Primary|Spontaneous Bowel Movements Per Week (SBMs/Week)|The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.|Week 1 to Week 2|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).|||number of stools/week||Standard Deviation|Mean
1459216|NCT00784277|Primary|5-Day Sum of Pain Intensity Difference (SPID5)|SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where “0” is no pain and “10” is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).|Day 1 to Day 5|Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).|||Units on a scale||Standard Deviation|Mean
1459217|NCT00784238|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Millimeter (mm)||Standard Deviation|Mean
1459218|NCT00784238|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Millimeter (mm)||Standard Deviation|Mean
1459238|NCT00784134|Secondary|Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS)|Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).|180 days|All the non-missing EuroQol scores at 180 days were analyzed.|||EuroQol score||Standard Deviation|Mean
1468269|NCT00719329|Primary|Colonization at Day 7 Swab|Were any organisms found on the swab collected on the day 07 visit?|First Week of Life|Intent to Treat|||Participants|||Number
1459219|NCT00784238|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459220|NCT00784238|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459221|NCT00784238|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1459222|NCT00784238|Primary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459223|NCT00784238|Primary|Drug Attitude Inventory (DAI-10) Total Score at Week 24|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459224|NCT00784238|Primary|Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459225|NCT00784238|Primary|Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1504185|NCT00440830|Secondary|Heart Rate|Heart rate reported in Beats per minute (BPM)|1 hour after surgery|||||||
1459226|NCT00784238|Primary|Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459227|NCT00784238|Primary|Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459228|NCT00784238|Primary|Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459229|NCT00784238|Primary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459230|NCT00784238|Primary|Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Week 24|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1459231|NCT00784147|Secondary|Mean Change From Baseline in CD4+ T-Cell Count at Week 24/EOS|The mean change in CD4+ T-cell count from the Baseline measurement at Week 24/End of Study was summarized at each scheduled time point by treatment group.|Week 24 / End of Study||||cell/mL||Standard Deviation|Mean
1459232|NCT00784147|Secondary|Mean Change From Baseline in Viral Load (log10) at Week 24/EOS|The mean change in HIV-1 RNA (log10) from the Baseline measurement was analyzed at Week 24/End of Study using a generalized linear model at each scheduled study visit.|Week 24 / End of Study||||log10 copies/mL||Standard Deviation|Mean
1459233|NCT00784147|Other Pre-specified|Proportion of Patients With a 0.5 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 0.5 log10 reduction from the Baseline measurement in HIV-1 RNA at Week 24 of the study.|Week 24||||percentage of patients|||Number
1459234|NCT00784147|Other Pre-specified|Proportion of Patients With a 1.0 log10 or Greater Reduction in Viral Load at Week 24|This efficacy assessment was performed in the same manner as the primary efficacy analysis for the proportion of the total population achieving at least a 1.0 log10 reduction from Baseline in HIV-1 RNA.|Week 24||||percentage of patients|||Number
1459235|NCT00784147|Other Pre-specified|Proportion of Patients With Viral Load <400 Copies/mL at Week 24|This efficacy measure was assessed in the same manner as the primary efficacy analysis to determine the proportion of the total population achieving HIV-1 RNA levels <400 copies at Week 24 of the study.|Week 24||||percentage of patients|||Number
1459239|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Recovery|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459240|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Participation|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459241|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Emotion|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459242|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Thinking|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459243|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Communication|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459244|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459245|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Hand Function|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459246|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Mobility|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459247|NCT00784134|Secondary|Quality of Life - Stroke Impact Scale (SIS) - Strength|Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.|180 days|All the non-missing SIS scores at 180 days were analyzed.|||SIS score||Standard Deviation|Mean
1459248|NCT00784134|Secondary|Functional Status - National Institutes of Health Stroke Scale (NIHSS)|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).|180 days|All the non-missing NIHSS scores at 180 days were analyzed.|||NIHSS score||Inter-Quartile Range|Median
1459249|NCT00784134|Secondary|Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.|180 days|All the non-missing eGOS scores at 180 days were analyzed.|||% of participants with score>=4|||Number
1459250|NCT00784134|Secondary|Functional Status - Barthel Index|Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.|180 days|All the non-missing Barthel scores at 180 days were analyzed.|||Barthel score||Standard Deviation|Mean
1459264|NCT00784134|Secondary|Safety/Mortality - Systematic Bleeds Within 30 Days|Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with systematic bleeds|||Number
1462072|NCT00763867|Other Pre-specified|High Sensitivity Troponin I||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1459251|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459252|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459253|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459254|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459255|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459256|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
1459257|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
1459258|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All male patients with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459259|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female)|Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All female patients with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459260|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were White with a non-missing mRS score at 180 days were analyzed.|||percentage of participants|||Number
1459261|NCT00784134|Secondary|Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American)|Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed.|||Percentage of participants|||Number
1459262|NCT00784134|Secondary|Predicting Hazards of Death by Treatment Group|Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
1459263|NCT00784134|Secondary|Adverse and Serious Adverse Events|Assessment of number of adverse and serious adverse events by treatment group.|180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
1459269|NCT00784134|Secondary|Intensity of Critical Care Management - Pneumonia|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with pneumonia|||Number
1459270|NCT00784134|Secondary|Intensity of Critical Care Management - All Infections|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with infections|||Number
1459271|NCT00784134|Secondary|Intensity of Critical Care Management - Shunts|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with shunts|||Number
1459272|NCT00784134|Secondary|Intensity of Critical Care Management - Pressors|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with pressors|||Number
1459273|NCT00784134|Secondary|Intensity of Critical Care Management - Mechanical Ventilation|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||% of participants with ventilation|||Number
1459274|NCT00784134|Secondary|Intensity of Critical Care Management - ICP Management|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Percentage of events of ICP >20mmHg|||Number
1459275|NCT00784134|Secondary|Intensity of Critical Care Management - ICU Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Number of days||Inter-Quartile Range|Median
1459276|NCT00784134|Secondary|Intensity of Critical Care Management - Hospital Days|Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.|30 days|All patients that were enrolled in CLEAR III were analyzed.|||Number of days||Inter-Quartile Range|Median
1459277|NCT00784134|Secondary|Clot Removal (Amount of Residual Blood)|Change in blood volume measured between stability scan and end of treatment scan|72 hours|All patients that were enrolled in CLEAR III were analyzed.|||odds ratio per time-weighted ml|||Number
1459278|NCT00784134|Secondary|All Cause Mortality||180 days|All patients that were enrolled in CLEAR III were analyzed.|||percentage of participants|||Number
1459279|NCT00784134|Primary|Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3|Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|30 days and 180 days|All the non-missing mRS scores at 30 days and 180 days were analyzed.|||Percentage of participants|||Number
1459280|NCT00784134|Primary|Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
1459281|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
1459282|NCT00784134|Primary|Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis|The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||mRS score||Inter-Quartile Range|Median
1459283|NCT00784134|Primary|Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis|Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).|180 days|All the non-missing mRS scores at 180 days were analyzed.|||percentage of participants|||Number
1459284|NCT00784095|Primary|QUAL-E Completion Sub-scale|A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
1459285|NCT00784095|Secondary|POMS Anxiety Sub-scale|The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.|Baseline, 6 and 8 week follow ups||||units on a scale||Standard Deviation|Mean
1460471|NCT00774397|Secondary|Change From Baseline to Week 24 in Haemoglobin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Haemoglobin at Week 24)|||g/dL||Standard Deviation|Mean
1459286|NCT00784095|Secondary|Center for Epidemiology Studies - Depression Scale (CES-D)|Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
1459287|NCT00784095|Secondary|Functional Status ADL|Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.|Baseline, 6 and 8 week follow ups||||units on a scale||Standard Deviation|Mean
1459288|NCT00784095|Primary|Quality of Life - Preparation|Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.|Baseline, 6 and 8 week follow up||||units on a scale||Standard Deviation|Mean
1459289|NCT00784043|Secondary|Speech Production Over Time in Children Implanted Bilaterally With a MED-EL Cochlear Implant.|Speech production scores over time on the Goldman-Fristoe test of articulation and the Kaufman speech praxis test for children.|5 years|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here.||||||
1459290|NCT00784043|Secondary|Language Acquisition Over Time in Bilaterally Implanted Children.|Scores over time on the MacArthur communicative development inventory.|60 months post initial activation|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here||||||
1459291|NCT00784043|Primary|Longitudinal Efficacy in Young Children Implanted Bilaterally With MED-EL COMBI 40+ / PULSARCI100/SONATATI100 Cochlear Implant Systems|Speech perception scores will be compared pre-operatively and postoperatively.|60 months post initial stimulation|Pre- and post-operative data were not collected for this outcome measure and thus no data is reported here||||||
1459292|NCT00784030|Primary|Change in Urine cAMP Concentration and Urine Osmolality (UOsm)|Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours|pre- and post-water loading (2 hours)|Number of participants was deemed to be adequate for the purposes of this pilot study|||fold change in cAMP/UOsm (umol/UOsm)||Standard Error|Mean
1459293|NCT00783965|Primary|Parameters of Safety: Number of Participants With Adverse Events According to NCI CTCAE v3.0||Baseline and 36 months||||participants|||Number
1459294|NCT00783965|Primary|Number of Participants With Reduction in the Observed Numbers of Basal Cell Carcinomas ≥ 9 mm² in Diameter||Baseline and 36 months||||participants|||Number
1459295|NCT00783952|Primary|Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations.|Four sensors of the 'Cerebral/Somatic Tissue Oximeter' device will be placed on subject's both sides of the forehead, palm and calf area. Simultaneously, blood samples will be drawn from the pulmonary artery catheter and arterial line for blood gas analyses. The values obtained from the device measurements will be used in a new equation to calculate the mixed venous oxygen saturation. The calculated value will be compared to the real value from the blood gas analysis for accuracy.|6 months||||percentage of oxygen saturation||Standard Deviation|Mean
1459296|NCT00783835|Secondary|Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12|It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening.|Screening (Week -2), 4 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459297|NCT00783835|Secondary|Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale|The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants.|Baseline, Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459298|NCT00783835|Secondary|Clinical Global Impression-Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).|Week 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459299|NCT00783835|Secondary|Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = Normal, not at all ill and a rating of 7 = Among the most extremely ill participants. Higher scores indicate worsening."|Screening (Week -2), 4, 8 and 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459310|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459300|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459301|NCT00783835|Primary|Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4|The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported.|Baseline and Week 4|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459302|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 12|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459303|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8|Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 8|ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459304|NCT00783835|Primary|Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4|Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).|Baseline and Week 4|Intent to treat efficacy evaluation (ITTe) included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness.|||Unit on a scale||Standard Error|Mean
1459305|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years|||||||
1459306|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years|||||||
1459307|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459308|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459309|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1461151|NCT00770991|Primary|Change in Burden of Rectal Polyps|The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.|Baseline and 36 weeks||||polyp number x mm||Standard Deviation|Mean
1459311|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
1459312|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
1459313|NCT00783796|Secondary|Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)|ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of participants||95% Confidence Interval|Number
1459314|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|5 years|||||||
1459315|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|4 years|||||||
1459316|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459317|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459318|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459319|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459320|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per ARC)|ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459321|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years|||||||
1459322|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years|||||||
1459365|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459323|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459324|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459325|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459326|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459327|NCT00783796|Secondary|Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)|Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459328|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years|||||||
1459329|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years|||||||
1459330|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459331|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1468270|NCT00719329|Primary|Colonization at Day 3 Swab|Were any organisms found on the swab collected on at Day 03|First Week of Life|Intent to Treat|||Participants|||Number
1459332|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459333|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459334|NCT00783796|Secondary|Clinically Indicated Target Lesion Revascularization (CI-TLR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459335|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|5 years|||||||
1459336|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|4 years|||||||
1459337|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459338|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459348|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459339|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459340|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459341|NCT00783796|Secondary|Clinically Indicated Target Vessel Revascularization (TVR)|Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459342|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|5 years|||||||
1459343|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|4 years|||||||
1459344|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459345|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459346|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459347|NCT00783796|Secondary|All TLR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459349|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|5 years|||||||
1459350|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|4 years|||||||
1459351|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459352|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459353|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459354|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459355|NCT00783796|Secondary|All TVR (CI and Non-CI)|Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459356|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|5 years|||||||
1459357|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|4 years|||||||
1459358|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459359|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459360|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459361|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459362|NCT00783796|Secondary|All Coronary Revascularization (TVR and Non-TVR)|Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459366|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459367|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459368|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459369|NCT00783796|Secondary|Cardiac Death/MI|This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459370|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|5 years|||||||
1459371|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|4 years|||||||
1459372|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459373|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459374|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459375|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459376|NCT00783796|Secondary|Cardiac Death/ All MI /CI-TLR|This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459377|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|5 years|||||||
1459378|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|4 years|||||||
1459379|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459535|NCT00782717|Secondary|Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).|BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.|From Day 7 to Day 90 (or Early Exit)|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).|||Percentage of patients|||Number
1459380|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459381|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459382|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459383|NCT00783796|Secondary|All Death/ All MI/All Coronary Revascularization|This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459384|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
1459385|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
1459386|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants|||Number
1459387|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 1123 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459388|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 - 758 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459389|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|31 days to 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459390|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|> 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459391|NCT00783796|Secondary|Stent Thrombosis (Protocol Defined)|Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459392|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 1123 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459393|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 758 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459394|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|Overall (0 - 393 days)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459395|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 1123 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459396|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|394 - 758 days (Very Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459397|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|>1 year (Very late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459398|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|31 days - 393 days (Late)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1470386|NCT00706004|Secondary|Serum Potassium||baseline and 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
1459399|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|greater than 1 day to 30 days (Subacute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459400|NCT00783796|Secondary|Stent Thrombosis (ARC Defined)|ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.|0 to 1 day (Acute)|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459401|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|5 years|||||||
1459402|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|4 years|||||||
1459403|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459404|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459405|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459406|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459407|NCT00783796|Secondary|Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)|Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459408|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|5 years|||||||
1459409|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|4 years|||||||
1459410|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).|3 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459411|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|2 years|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||percentage of participants||95% Confidence Interval|Number
1459412|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459413|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|240 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459414|NCT00783796|Secondary|All Death (Cardiac, Vascular, Non-cardiovascular)|All death, including death from cardiac, vascular, and non-cardiovascular causes.|30 days|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants||95% Confidence Interval|Number
1459415|NCT00783796|Secondary|Distal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1459416|NCT00783796|Secondary|Proximal Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1459417|NCT00783796|Secondary|In-segment Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1459418|NCT00783796|Secondary|In-stent Angiographic Binary Restenosis (ABR) Rate|Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage of Participants||95% Confidence Interval|Number
1459419|NCT00783796|Secondary|Distal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1459420|NCT00783796|Secondary|Proximal % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1459421|NCT00783796|Secondary|In-segment % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1459422|NCT00783796|Secondary|In-stent % Diameter Stenosis|Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Percentage||Standard Deviation|Mean
1459423|NCT00783796|Secondary|Distal Late Loss|Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeter||Standard Deviation|Mean
1459424|NCT00783796|Secondary|Proximal Late Loss|Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeter||Standard Deviation|Mean
1459425|NCT00783796|Secondary|In-segment Late Loss (LL)|In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.|240 Days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeters||Standard Deviation|Mean
1459426|NCT00783796|Secondary|In-Stent Late Loss|In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.|240 days|Based on Angiographic Cohort Full Analysis Set (FAS) population, defined as subjects in the Angiographic Cohort who have received the investigational study device (2.25 mm XIENCE V stent).|||Millimeters||Standard Deviation|Mean
1459784|NCT00781599|Secondary|Cotinine Verified 7 Day Point Prevalence Smoking Abstinence|Smoking cessation verified by salivary cotinine (COT). A COT of <20 ng/ml indicated smoking abstinence.|Month 3|A total of 61 participants completed the final month 3 visit. The 11 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
1459427|NCT00783796|Secondary|Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)|Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.|From the start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects.|||Percentage of Participants|||Number
1459428|NCT00783796|Secondary|Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)|Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.|From start of index procedure to end of index procedure|Based on Intent To Treat (ITT) population, defined as subjects enrolled in the study, regardless of the treatment actually received, and excluding de-registered subjects|||Percentage of Lesions|Participants||Number
1459429|NCT00783796|Primary|Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).|This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.|1 year|The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device (2.25 mm XIENCE V stent) and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization).|||Percentage of Participants|||Number
1459430|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.|||percentage of participants||95% Confidence Interval|Number
1459431|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission."|Week 6 and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459432|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459433|NCT00783718|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Response|"Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response."|Baseline, Week 6 and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459434|NCT00783718|Secondary|Induction Phase: Percentage of Participants With Mucosal Healing at Week 6|"Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).~All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing."|Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459472|NCT00783302|Primary|The Specificity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Specificity of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
1459435|NCT00783718|Secondary|Induction Phase: Percentage of Participants in Clinical Remission at Week 6|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459436|NCT00783718|Primary|Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52|"Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.|||percentage of participants||95% Confidence Interval|Number
1459437|NCT00783718|Primary|Induction Phase: Percentage of Participants With a Clinical Response at Week 6|"Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.~The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).~All participants who prematurely discontinued for any reason were considered as not achieving clinical response."|Baseline and Week 6|Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
1459438|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1459439|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1459440|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||mmol/L||Inter-Quartile Range|Median
1459441|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1459442|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||pg/mL||Inter-Quartile Range|Median
1459471|NCT00783302|Primary|The Negative Predictive Value (NPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Negative Predictive Value (NPV) of Visipaque-enhanced CCTA for ruling out downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
1459443|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||pg/mL||Inter-Quartile Range|Median
1459444|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1459445|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available|||ng/mL||Inter-Quartile Range|Median
1459446|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||umol/L||Inter-Quartile Range|Median
1459447|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1459448|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1459449|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1459450|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||pg/mL||Inter-Quartile Range|Median
1459451|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||pg/mL||Inter-Quartile Range|Median
1462073|NCT00763867|Other Pre-specified|Aldosterone||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1459452|NCT00783705|Secondary|Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA)|The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems).|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available|||ng/mL||Inter-Quartile Range|Median
1459453|NCT00783705|Secondary|Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray||From baseline up to 6 months|Data were not collected due to a study team decision not to analyze this endpoint.||||||
1459454|NCT00783705|Secondary|Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia||From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.|||percentage of Ki67 expression level||Standard Deviation|Mean
1459455|NCT00783705|Secondary|Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment|The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions.|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied.|||percentage change in number of lesions||Standard Deviation|Mean
1459456|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis.|"The definitions of responses are:~Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease"|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
1459457|NCT00783705|Primary|Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis.|"The definitions of responses are:~Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression."|From baseline up to 6 months|The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy.|||percentage of participants|||Number
1459458|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|"Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission"|Assessed every 4 weeks from Week 6 to Week 50, and at Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459459|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52|"Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission."|Week 52|Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.|||percentage of participants||95% Confidence Interval|Number
1459460|NCT00783692|Secondary|Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 52|Maintenance Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459461|NCT00783692|Secondary|Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6|C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).|Baseline and Week 6|Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group.|||mg/L||Full Range|Median
1459529|NCT00782795|Primary|Insulin Sensitivity Index for Glycemia at 24 Weeks|"Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).~GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.~INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin."|24 weeks||||numeric index||Standard Deviation|Mean
1459462|NCT00783692|Primary|Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52|"Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 52|Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.|||percentage of participants||95% Confidence Interval|Number
1459463|NCT00783692|Primary|Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6|"Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to 600 with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."|Baseline and Week 6|Induction Study ITT Population|||percentage of participants||95% Confidence Interval|Number
1459464|NCT00783692|Primary|Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6|"Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.~The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:~Number of liquid or soft stools each day for 7 days;~Abdominal pain (graded from 0-3 on severity) each day for 7 days;~General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;~Presence of complications;~Taking Lomotil or opiates for diarrhea;~Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);~Hematocrit of < 0.47 in men and < 0.42 in women;~Percentage deviation from standard weight.~The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.~All participants who prematurely discontinued for any reason were considered as not achieving clinical remission."|Week 6|Induction Study Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.|||percentage of participants||95% Confidence Interval|Number
1459465|NCT00783614|Primary|Blood Markers of Inflammation, Endothelial Injury, and Thrombosis||changes from baseline to 6 months|Data measurements not obtained, as study terminated early due to poor enrollment||||||
1459466|NCT00783614|Primary|Number of Participants With Side Effects (Self-report) Number of Participants With Adverse Events|At each visit participants were asked if they were experience side effects to study medications. They were also asked if any new events or symptoms occurred since the last visit, even if they did not suspect it was related to the study medication|6 months|The number of participants with adverse events or reporting side effects|||participants|||Number
1459467|NCT00783432|Secondary|Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.|The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.|baseline, months 1,3,6,9 and 12/or early termination|Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.|||Units on a scale||Standard Deviation|Least Squares Mean
1459468|NCT00783432|Primary|Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.|Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.|baseline and 12 months/ET||||Participants|||Number
1459469|NCT00783432|Primary|Number of Participants Reporting Adverse Events|An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.|12 months|Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.|||Participants|||Number
1459470|NCT00783302|Secondary|Summary of Subjects Developing 1 or More Positive and Negative Cardiac Clinical Outcomes at 1 Month, 6 Months, and 12 Months After Undergoing Coronary Computed Tomography Angiography (CCTA) Examination Using Visipaque.|"The number of subjects in the efficacy population developing 1 or more positive and negative cardiac clinical outcomes at 1 month, 6 months, and 12 months after undergoing a Coronary Computed Tomography Angiography (CCTA) examination using Visipaque. Clinical outcomes are independent of any serious adverse events and adverse events associated with the drug administration.~This outcome measure is not reporting those subjects with serious adverse events and adverse events associated with the drug administration."|Within 1 month, 6 months and 12 months post contrast administration.||||Number of Subjects|||Number
1459769|NCT00781911|Secondary|PK: Volume at Steady State (Vss) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1459473|NCT00783302|Primary|The Positive Predictive Value (PPV) of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Ruling Out Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Positive Predictive Value (PPV) of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT.The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.||||Percentage of Subjects||95% Confidence Interval|Number
1459474|NCT00783302|Primary|The Sensitivity of Visipaque-enhanced Coronary Computed Tomography Angiography (CCTA) for Predicting Downstream Cardiovascular Events at Each Follow-up Period When Compared to the Standard of Truth (SoT).|Statistical analysis of the Sensitivity of Visipaque-enhanced CCTA for predicting downstream cardiovascular events at each follow-up period when compared to the SoT. The results are calculated as percentage of participants.|Within 1 month, 6 months and 12 months post contrast administration.|The subject follow-up period went from 1 month, 6 months and 12 months.|||Percentage of Subjects||95% Confidence Interval|Number
1459475|NCT00783263|Secondary|Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels|Participants who were analyzed to assess the Total Cholesterol (TC), Triglycerides, High-Density Lipoprotein Cholesterol, Non High-Density Lipoprotein Cholesterol, LDL Cholesterol/HDL Cholesterol, Total Cholesterol/HDL Cholesterol, Non-HDL Cholesterol/HDL Cholesterol, Apolipoprotein B (Apo B), Apolipoprotein A-I (Apo A-I), Apolipoprotein B/Apo A-I, high-sensitivity C-reactive protein (hs-CRP)levels after 6 weeks of treatment.|Baseline to 6 weeks||||percentage change||Standard Deviation|Mean
1459476|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl|Participants in stratum I and in stratum II who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe to rosuvastatin (5 or 10 mg)daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg).|6 weeks of treatment||||participants|||Number
1459477|NCT00783263|Secondary|Number of Participants Who Reached the LDL-C Level of <70 mg/dl|Participants across all strata who reached the LDL-C Level of <70 mg/dl after the addition of ezetimibe 10 mg to rosuvastatin (5 or 10 mg) daily for 6 weeks compared with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|6 weeks of treatment||||participants|||Number
1459478|NCT00783263|Secondary|Number of Participants in Each Stratum Who Reached Their Target LDL-C Level|Participants in stratum I were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 5 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 10 mg daily for 6 weeks. Participants in stratum II were analyzed to evaluate the LDL-C lowering efficacy with the additional of ezetimibe 10 mg to rosuvastatin 10 mg daily for 6 weeks compared with doubling the baseline dose to rosuvastatin 20 mg daily for 6 weeks.|6 weeks of treatment||||participants|||Number
1459479|NCT00783263|Secondary|Number of Participants Who Reached Their Target LDL-C Level|Participants were analyzed to evaluate the LDL-C (<100 mg/dL for moderately high risk patients and high risk patients without AVD and <70 mg/dL for high risk patients with AVD) lowering efficacy with the addition of ezetimibe 10 mg to (5 or 10 mg) compared with doubling the baseline rosuvastatin (10 or 20 mg), daily for 6 weeks of treatment.|6 weeks of treatment||||participants|||Number
1459480|NCT00783263|Secondary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment by stratum I and stratum II in participants who were administered with ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with the doubling of the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks||||percentage change||Standard Deviation|Mean
1459481|NCT00783263|Primary|Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment|The percent change from baseline in LDL-C (mg/dL) after 6 weeks of treatment in participants who were administered ezetimibe 10 mg to rosuvastatin (5 or 10 mg) in comparison with doubling the baseline dose of rosuvastatin (10 or 20 mg) daily for 6 weeks.|Baseline to 6 weeks||||percent change||Standard Deviation|Mean
1459482|NCT00783224|Primary|Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks|The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.|Baseline to 2 weeks of treatment||||Units on a scale||Standard Error|Least Squares Mean
1459483|NCT00783198|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36, with a lower score indicating less rhinoconjuntivitis medication use. Raw means for DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1459484|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1459530|NCT00782795|Primary|Glucose Tolerance at 48 Weeks|"Normal = normal plasma glucose and normal glucose tolerance (OGTT).~Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.~Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl."|48 weeks||||Participants|||Count of Participants
1459485|NCT00783198|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjuntivitis symptoms. Raw means for DSS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1459486|NCT00783198|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to GCP issues.|||score on a scale||Standard Error|Mean
1459487|NCT00783198|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medicationwith different rescue medications being assigned different scores/dose unit. The maximum rhinoconjunctivitis DMS score was 36. The sum of the rhinoconjunctivitis DSS and DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means for DSS+DMS were converted to adjusted means based on an analysis of variance (ANOVA) model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement. A total of 5 participants at one site were excluded from all efficacy analyses due to Good Clinical Practice (GCP) issues.|||score on a scale||Standard Error|Mean
1459488|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint|Post residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||milliliter||Standard Deviation|Mean
1459489|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||microgram/liter||Standard Deviation|Mean
1459490|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 54-Week Endpoint||Baseline, 54-weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||beats per minute (bpm)||Standard Deviation|Mean
1459491|NCT00783094|Secondary|Change From Baseline in Blood Pressure During at 54-Week Endpoint||Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1459492|NCT00783094|Secondary|Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment|A listing of Adverse Events are reported in the Reported Adverse Event Section.|End of 12 weeks of double-blind through 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||participants|||Number
1459493|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1459494|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1459495|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 54 weeks|All participants enrolled in the open-label extension who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1459496|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 54 weeks|All participants enrolled in the open-label phase who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1459783|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 1|A total of 60 participants completed the month 1 visit. The 12 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
1459497|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1459498|NCT00783094|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 54 weeks|All participants enrolled in the open-label extension period who received at least 1 dose of tadalafil.|||units on a scale||Standard Deviation|Mean
1459499|NCT00783094|Secondary|Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint|Measurement of nanograms of PSA per milliliter (ng/mL) of blood.|Baseline, 12 weeks|Safety Analysis Set: All randomized participants who received study treatment grouped by the treatment actually taken.|||Micrograms per liter||Standard Deviation|Mean
1459500|NCT00783094|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint|Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.|Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||milliliters||Standard Deviation|Mean
1459501|NCT00783094|Secondary|Change From Baseline in Sitting Heart Rate at 12-Week Endpoint||Baseline, 12 Weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||beats per minute||Standard Deviation|Mean
1459502|NCT00783094|Secondary|Change From Baseline in Blood Pressure at 12-Week Endpoint||Baseline, 12 weeks|Safety Analysis Set: all randomized participants who received study treatment grouped by the treatment actually taken.|||mmHg||Standard Deviation|Mean
1459503|NCT00783094|Secondary|Number of Participants With Adverse Events During 12 Weeks of the Study|A listing of Adverse Events are reported in the Reported Adverse Event Section.|Baseline through 12 weeks|All randomized participants|||participants|||Number
1459504|NCT00783094|Secondary|Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement|Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.|Baseline, 12 weeks|Participants who received 2.5 mg or 5 mg tadalafil once daily during the double-blind period.|||nanogram/milliliter||Standard Deviation|Geometric Mean
1459505|NCT00783094|Secondary|Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint|Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||milliliters per second||Standard Error|Least Squares Mean
1459506|NCT00783094|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint|The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1459507|NCT00783094|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint|Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1459508|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint|IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1459509|NCT00783094|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint|IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1459510|NCT00783094|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint|The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, 12 weeks|Participants in the Full Analysis Set (FAS): participants who were randomized and started study medication.|||units on a scale||Standard Error|Least Squares Mean
1459511|NCT00782834|Primary|Response Rate|Response rate of nilotinib by RECIST criteria evaluated every 2 months for the first 6 months then every 3 months for the duration of treatment period.|1year||||Participants|||Number
1459512|NCT00782834|Primary|Progression Free Survival Rate at 6 Months|Number of participants that demonstrate progression free survival at 6 months|6 months||||Participants|||Number
1459513|NCT00782821|Secondary|Patient Allograft Survival at 12 Months|Patient's allograft was still functioning at 12 months post study enrollment|12 months||||participants|||Number
1459514|NCT00782821|Secondary|Patient Survival at 12 Months|Patient was still alive 12 months post study enrollment.|12 months||||participants|||Number
1459531|NCT00782795|Primary|Glucose Tolerance at 24 Weeks|"Normal = normal plasma glucose and normal glucose tolerance (OGTT).~Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.~Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl."|24 weeks||||Participants|||Count of Participants
1459515|NCT00782821|Secondary|Acute Cellular Rejection by Banff '97 Criteria (Updated 2005)|"Acute cellular rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months||||participants|||Number
1459516|NCT00782821|Secondary|Antibody-mediated Rejection by Banff '97 Criteria (Updated 2005)|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria. Rejection due, at least in part, to documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated); may coincide with categories 3, 4 and 5.~Grade I. ATN-like – C4d+, minimal inflammation Grade II. Capillary- margination and/or thromboses, C4d+ Grade III. Arterial – v3, C4d+"|6 months||||participants|||Number
1459517|NCT00782821|Primary|Incidence of Acute Rejection (Banff ’97) or Antibody Mediated Rejection|"Antibody mediated rejection demonstrated to be due to, atleast in part, to anti-donor antibody at 6 months by Banff 97' criteria.~Acute rejection IA - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).~IB - cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of severe tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells) IIA - cases with mild to moderate intimal arteritis (v1) IIB - cases with server intimal arteritis comprising >25% of the luminal area (v2) III - case with transmural arteritis and/or arterial fibrinoid change and necrosis of medical smooth muscle cells (v3 with accompanying lymphoctic inflammation)"|6 months||||participants|||Number
1459518|NCT00782795|Secondary|Insulin Sensitivity (%S)|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/;|24 and 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||insulin sensitivity (%)||Standard Deviation|Mean
1459519|NCT00782795|Secondary|Missed Work|Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks)|12, 24, 36, 48, 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||days||Standard Deviation|Mean
1459520|NCT00782795|Secondary|Hospitalizations|Mean number of hospitalizations within the prior 12 weeks|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||hospitalizations||Standard Deviation|Mean
1459521|NCT00782795|Secondary|Body Mass Index (BMI)|standard BMI defined as mass in kilograms divided by height in meters squared|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||kg/m^2||Standard Deviation|Mean
1459522|NCT00782795|Secondary|Pain|"Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)~What is your pain right now?~What is your typical or average pain in the last 12 weeks?~What is your pain level at its best in the last 12 weeks (how close to “0” does your pain get at its best)?~What is your pain level at its worst in the last 12 weeks (how close to “0” does your pain get at its worst)?"|12, 24, 36, 48 and 60 weeks|Some participant data is missing from some weeks, due to incomplete forms in certain instances.|||units on a scale||Standard Deviation|Mean
1459523|NCT00782795|Secondary|Number and Percentage of Participants With Steatorrhea|Participants were counted as having steatorrhea if they had either a) positive qualitative fecal fat; or b) 72 hour quantitative fecal fat result with >7g fat in stool in 24hours|48 weeks||||Participants|||Count of Participants
1459524|NCT00782795|Secondary|Quality of Life|The SF36 (Short Form with 36 questions) QoL scoring system has 36 questions, comprising two main dimensions (Physical Health and Mental Health), further divided by 8 independent scales (Physical functioning, Role-Physical, Bodily pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health). The scales for general health and mental health overlap components of both the two main dimensions (Physical Health and Mental Health). The scales, including the total score and dimensions are scored as a number between 0 and 100, where 0 represents lower limits of functioning and 100 is best functioning possible. Data reported is the average total score.|24, 48 weeks|The 24 week data has two participants' data missing from each arm because it was not available.|||units on a scale||Standard Deviation|Mean
1459525|NCT00782795|Secondary|Pancreas Ultrasound Appearance|"Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features:~Parenchymal Features - Only Body and Tail~Calcification (>3 hyperechoic foci >2 mm length & width with shadowing)~Lobularity (>3 well-circumscribed, >5mm structures)~Hyperechoic stranding (>3 hyperechoic lines >3mm in length, seen in > 2 different directions with respect to the imaged plane Parenchymal Features - Head, Body and Tail~Cyst (>2 mm diameter anechoic round or oval structure)~Hyperechoic foci (>3 reflectors, >3 mm long & wide, no shadowing) Ductal Features - Only Body and Tail~Side Branch Dilation (>3 tubular, anechoic, >1 mm structures,Main pancreatic duct (MPD) connects)~Irregular MPD contour (uneven and ectatic in its course)~Hyperechoic MPD margin (hyperechoic in >50% of MPD)~Dilation MPD (>3.5 mm body, >1.5 mm tail*) Ductal Features - Head, Body and Tail~MPD calculi (hyperechoic foci with shadowing contained within MPD)"|48 weeks||||units on a scale||Inter-Quartile Range|Median
1459526|NCT00782795|Secondary|Insulin Resistance at 24 and 48 Weeks|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/|24, 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||HOMA2-IR||Standard Deviation|Mean
1459527|NCT00782795|Secondary|Beta-cell Function|Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/|24, 48 weeks|1 participant on the placebo side was no longer participating at 48 weeks|||Beta-cell function (%)||Standard Deviation|Mean
1459528|NCT00782795|Primary|Insulin Sensitivity Index for Glycemia at 48 Weeks.|"Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).~GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.~INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin."|48 weeks||||numeric index||Standard Deviation|Mean
1506259|NCT00425269|Secondary|Diastolic Blood Pressure, Baseline||baseline||||mmHg||95% Confidence Interval|Mean
1459536|NCT00782717|Primary|Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery|Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).|3 Months|All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).|||Percentage of patients|||Number
1459537|NCT00782639|Primary|Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit|Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||milligrams per deciliter (mg/dL)|||Number
1459538|NCT00782639|Secondary|Number of Participants Who Died From Acute Renal Failure|This outcome measure provides the total number of participants who died as a result of acute renal failure.|Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)||||Participants|||Number
1459539|NCT00782639|Secondary|Number of Participants Requiring Dialysis|This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.|48 to 72 hours after injection of contrast media||||Participants|||Number
1459540|NCT00782639|Secondary|The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)|This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||Participants|||Number
1459541|NCT00782639|Secondary|The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)|This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.|Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media||||Participants|||Number
1459542|NCT00782639|Primary|The Number of Participants With Contrast-induced Nephropathy (CIN)|The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.|48 to 72 hours After Injection of Contrast Media||||Participants|||Number
1459543|NCT00782626|Primary|Overall Response|Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy.Description: Overall response is classified as complete response (CR), partial response (PR), stable disease (SD) or Progressive Disease (PD) on therapy. Response for target lesions (up to5) is based on 3 dimensions with an elliptical model volume used: 0.5L*W*T; (L) tumor extent in plane perpendicular to the selected plane; (W) longest measurement of the tumor width; (T) transverse measurement perpendicular to the width. CR is disappearance all target and non-target lesions and no new lesions. PR is >/= 65% decrease in sum of the products (referent baseline). PD 40% or more increase in any target lesion (referent smallest product observed on therapy). SD is none of the above. PR and SD classification as long as absent new lesions and unequivocal progression for non-target lesions else PD.|Disease evaluations (MRI brain, including volumetric analysis) occurred at baseline, at the end of course 1, every 3 courses during treatment up to 12 courses and at early treatment discontinuation.|The analysis dataset is comprised of all evaluable patients. All treated patients were evaluable.|||participants|||Number
1459544|NCT00782509|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.|||mmol/L||Standard Deviation|Mean
1459545|NCT00782509|Secondary|Changes in Safety Parameters Related to Treatment|Occurence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.|||percentage of participants|||Number
1459546|NCT00782509|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Mean number of moderate COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
1459547|NCT00782509|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Mean number of COPD exacerbations requiring hospitalization per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
1459548|NCT00782509|Secondary|Number of COPD Exacerbations|Mean number of COPD exacerbations per patient years. Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||COPD exacerbations||Standard Error|Mean
1462074|NCT00763867|Other Pre-specified|N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pg/mL||Standard Deviation|Mean
1459549|NCT00782509|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol.Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Moderate exacerbations were defined as exacerbations which did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor.Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval..|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1459550|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measured values presented are actually the First Quartile and 95% confidence interval.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1459551|NCT00782509|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|"Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank.~The measured values presented are actually the First Quartile and 95% confidence interval."|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1459552|NCT00782509|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS|||Point on scale||Standard Error|Mean
1459553|NCT00782509|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS|||Point on scale||Standard Error|Mean
1459554|NCT00782509|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS|||Point on scale||Standard Error|Mean
1459555|NCT00782509|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS|||Point on scale||Standard Error|Mean
1459556|NCT00782509|Secondary|Weekly Mean of Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each 24 hour period during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
1459557|NCT00782509|Secondary|Weekly Mean of Daily Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each night during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
1459558|NCT00782509|Secondary|Weekly Mean of Daily Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night. The weekly mean was calculated by taking the average of the number of puffs of rescue medication used each day during week 48.|Week 48|FAS|||Number of puffs||Standard Error|Mean
1459559|NCT00782509|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS|||L/min||Standard Error|Mean
1459560|NCT00782509|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS|||L/min||Standard Error|Mean
1459561|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1459809|NCT00781274|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1459562|NCT00782509|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1459563|NCT00782509|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459564|NCT00782509|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1459565|NCT00782509|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1459566|NCT00782509|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459567|NCT00782509|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours aftertreatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1459568|NCT00782509|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1459569|NCT00782509|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1459570|NCT00782509|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1459608|NCT00782418|Primary|Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose|"Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate.~Insulin Secretion Rate (ISR)/ Blood Glucose (BG)"|Steady-state of HGC: 90 – 120 minutes post dose; highest glucose infusion rate of GGI: 120 – 160 minutes post dose|All subjects treated|||(ng/min) / (mg/dL)||Full Range|Geometric Mean
1459571|NCT00782509|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1459572|NCT00782509|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1459573|NCT00782509|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS|||Liter||Standard Error|Mean
1459574|NCT00782509|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1459575|NCT00782509|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1459576|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1459577|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459578|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1459579|NCT00782509|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1462075|NCT00763867|Other Pre-specified|Uric Acid||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1459580|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459581|NCT00782509|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1459582|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1459583|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459584|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1459585|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1459586|NCT00782509|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459587|NCT00782509|Secondary|Peak FEV1 (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1459588|NCT00782509|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1459609|NCT00782379|Secondary|Disease Free Survival at Day 100|Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.|Day 100|17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100|||participants|||Number
1462076|NCT00763867|Other Pre-specified|Cystatin C||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/L||Standard Deviation|Mean
1459589|NCT00782509|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1459590|NCT00782509|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1459591|NCT00782509|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1459592|NCT00782509|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1459593|NCT00782509|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1459594|NCT00782509|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1459595|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1459596|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459610|NCT00782379|Secondary|Disease Free Survival at 12 Months|Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.|12 months|14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year|||participants|||Number
1459611|NCT00782379|Secondary|Overall Survival at 12 Months|Overall survival, defined as a patient being alive after transplant, is without regard to disease status.|12 months|20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year|||participants|||Number
1459597|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1459598|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459599|NCT00782509|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1459600|NCT00782509|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1459601|NCT00782509|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS|||Liter||Standard Error|Mean
1459602|NCT00782509|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.|||Liter||Standard Error|Mean
1459603|NCT00782496|Secondary|Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2|Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.|Over six month period|63 surveys were available for analysis.|||percent of Level 2 participants|||Number
1459604|NCT00782496|Primary|Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features||6 months|For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.|||number of post-prandial tests per week||Standard Error|Mean
1459605|NCT00782483|Primary|Average Laser Setting to be Used to Treat Port Wine Stains as Measured by Mathematical Calculations Based on Imaging and Temperature Analysis of Malformation.|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.|Three treatments up to one year, whichever is first|6 subjects were enrolled but no data was ever collected due to early termination of the study due to the PI's relocation.||||||
1459606|NCT00782418|Primary|Change From Baseline in Insulin Concentration||Pre and Post glucose infusion|All subjects treated|||μIU(insulin)/mL||Full Range|Least Squares Mean
1459607|NCT00782418|Primary|Change From Baseline in C-peptide Concentration||Pre and Post glucose infusion|All subjects treated|||ng/mL||Full Range|Least Squares Mean
1459612|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 90|13 patients had chimerism drawn at Day 90|||participants|||Number
1459613|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 60|18 patients had chimerism drawn at Day 60|||participants|||Number
1459614|NCT00782379|Secondary|Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)||Day 100|2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality|||participants|||Number
1459615|NCT00782379|Secondary|Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation|Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.|Day 30|18 patients had Day 30 chimerism drawn|||participants|||Number
1459616|NCT00782379|Secondary|Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)|Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.|1 year|6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality.|||participants|||Number
1459617|NCT00782379|Secondary|Overall Survival at Day 100|Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.|Day 100|20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival|||participants|||Number
1459618|NCT00782379|Primary|Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)|Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence|Day 100|17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease|||participants|||Number
1459619|NCT00782379|Primary|Incidence of Graft Rejection for Patients at Day 100|Number of patients who experienced graft rejection by Day 100|Day 100|20 patients were treated and able to be analyzed for graft rejection|||participants|||Number
1459620|NCT00782340|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. A positive score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days||||mmHg||Standard Deviation|Mean
1459621|NCT00782340|Secondary|Clinician-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days||||participants|||Number
1459622|NCT00782340|Secondary|Patient-Reported Clinical Global Improvement - Severity Scores|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2), Mild-Moderate OH (CGI-S 3-4), Marked OH-Most Ill with OH (CGI-S 5-7)."|7 days||||participants|||Number
1459623|NCT00782340|Secondary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1459624|NCT00782340|Secondary|Change in Activities Involving Walking a Short Time (OHDAS Item 3)|OHDAS Item 3 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1459625|NCT00782340|Secondary|Change in Activities Involving Standing a Short Time (OHDAS Item 1)|OHDAS Item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1459626|NCT00782340|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA Composite) Score|OHSA composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1459627|NCT00782340|Secondary|Change in Ability to Conduct Activities of Daily Living Score (OHDAS Composite Score)|OHDAS composite scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A negative score indicates an improvement during the double-blind randomized phase relative to value at randomization.|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1459640|NCT00782288|Secondary|Pharmacokinetics (PK) of Digitoxin in Serum in Stable CF Patients.|Digitoxin serum levels were drawn on Days 1 (pre-dose), 7, 14, 21 and 42. The range of digitoxin levels for each visit is listed and the number of subjects who had that level are marked by group (placebo, low dose and high dose).|Serum PK on Days 1 (pre-dose), 7, 14, 21 and 42|Subjects had serum digitoxin levels drawn at Day 1 (pre-dose) with no levels observed, as expected. Digitoxin was drawn on Day 7, 14, 21 and 42 to determine the number of subjects with a detectable level of digitoxin (ng/mL) in serum by group.|||participants|||Number
1459628|NCT00782340|Primary|Change in Orthostatic Hypotension Questionnaire Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~For the change from randomization, negative numbers represent improvement from randomization in OHQ score."|7 days|Missing data are imputed using the last observation carried forward method.|||units on a scale||Standard Deviation|Mean
1459629|NCT00782288|Secondary|Clinically Significant Changes in the Microbiology of Sputum in Subjects|Count of clinically significant changes in sputum microbiology during the Treatment phase (Day 1 to Day 28) to include any new acquisition of B. cepacia or new acquisition of any multiple resistant organism.|28 days|There were no significant changes in the microbiology of sputum in any subjects over the course of treatment.|||participants|||Number
1459630|NCT00782288|Secondary|Clinically Significant Alterations in ECG Readings|Safety indices included an assessment for the number of clinically significant alterations in the subjects ECG readings from Day 1 to Day 28.|28 days|Count of clinically significant alterations in the ECG in all subjects during the Treatment Phase of the study.|||participants|||Number
1459631|NCT00782288|Secondary|Number of CF Subjects With Microarray Results From Nasal Epithelial Cells to Measure the Effect of Digitoxin on Gene Expression.|Rhinoprobe was used to collect nasal epithelial cells. The cells were collected pre and post-treatment and placed in Trizol for RNA isolation then used to measure the effect of digitoxin on gene expression. The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). The accession number for that data is GSE76347 (data available Dec 2018).|Day 0 and Day 28|The full set of microarray data has been deposited in the National Center for Biotechnology Information (NCBI) Gene Expression Omnibus (GEO). Results can be found under the accession number GSE76347. One subject's pair of specimens in the placebo group was not collected.|||participants|||Number
1459632|NCT00782288|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR) During Treatment Period.|Median change in serum ESR (mm/hr) and IQR was calculated from Treatment Period (28 days).|Baseline and Day 28|All subjects had blood labs for ESR drawn on Visits 1,3,4 and 5. The changes in median ESR were calculated during the Treatment Period (28 days).|||mm/hr||Inter-Quartile Range|Median
1459633|NCT00782288|Secondary|Changes in C Reactive Protein (CRP) During Treatment.|Median changes in CRP and IQR were assessed from serum samples collected at Visits 1,3, 4 and 5.|Baseline and Day 28|All subjects had blood labs for CRP drawn on Visits 1,3,4 and 5. The changes in median CRP were calculated during the Treatment Period (28 days).|||mg/dL||Inter-Quartile Range|Median
1459634|NCT00782288|Primary|Change in Neutrophil Cell Count Day 28 Minus Day 1 (Treatment Period).|The change in log 10 neutrophil cell count from Day 28 minus Day 1 (during the treatment period) expressed as log (10^4 neutrophil/mL).|28 days (Day 28 minus Day 1)|The change in neutrophil cell count from Day 1 to Day 28 was performed using a Kruskal-Wallis equality of populations rank test. The cells counts are expressed as log 10 (neutrophil cell/mL).|||log 10 (neutrophil cell/mL)||Inter-Quartile Range|Median
1459635|NCT00782288|Primary|Effect of Digitoxin on Neutrophil Counts in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The neutrophil counts were measured in the induced sputum of participants in each group on study 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1- Day 42)|Neutrophil cell counts were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between the placebo and the two digitoxin dose levels.|||log 10 (neutrophil cells/mL)||Inter-Quartile Range|Median
1459636|NCT00782288|Primary|Change in Il-8 (Interleukin 8) Levels From Day 28 Minus Day 1 (Treatment Period).|Change in Il-8 values are expressed as a change in log 10 Il-8 pg/mL from Day 28 minus Day 1.|28 days (Day 28 minus Day 1)|For change in Il-8 from Day 28 minus Day 1, a Kruskal-Wallis equality of populations rank was performed.|||log10 (pg/mL)||Inter-Quartile Range|Median
1459637|NCT00782288|Secondary|Change in WBC (White Blood Cell) Count by Group During Treatment Period|Safety indices included changes in FEV1 (lung function), changes in WBC, alterations in ECG and sputum microbiology. There were no significant alterations in the ECG in any subjects over the course of the study. There were no subjects who acquired multiple resistant changes in microbiology of sputum and no acquisition of B. cepacia in any subjects. Therefore, these data were not analyzed. The median changes in FEV1 and median changes in WBC, ESR and CRP are reported.|Baseline and Day 28|Safety indices included changes in WBC during treatment for each group.|||K/cu mm||Inter-Quartile Range|Median
1459638|NCT00782288|Secondary|Mean Change in Quality of Life Scores, for Each Domain, From Day 1 to Day 42 Using the Cystic Fibrosis Questionnaire Revised (CFQ-R).|"CFQ-R is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms. Developed specifically for use in patients with a diagnosis of cystic fibrosis. There are 9 Quality of life domains: physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions and 3 symptom scales: weight, respiratory, and digestion.~Scaling of items is done via 5 distinct 4-point Likert scales. Scores for each domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health. Based on clinician judgment of global clinical change, a moderate change was a standardized effect size of 0.50 units and an important change was a standardized effect size of 0.80 units evaluating pre- and post-treatment for CF exacerbation. Mean changes in CFQ-R Scores by Group were evaluated between Visit 6 and Visit 1, by Domain."|Baseline and Day 42|Mean change in CFQ-R scores from Visit 1 to Visit 6, by domain.|||mean change of scores on a scale||Standard Deviation|Mean
1459639|NCT00782288|Secondary|Safety Indices Including Change in FEV1 in Stable CF Patients.|Safety indices included changes in FEV1 (forced expiratory volume in 1 second), changes in WBC (white blood cell count), alterations in ECG and sputum microbiology. The median changes in FEV1 are reported.|Baseline and Day 28|Median changes in FEV1 in L by group for the 28 days of treatment.|||liters||Inter-Quartile Range|Median
1470387|NCT00706004|Secondary|Serum Chloride||baseline and 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
1459641|NCT00782288|Primary|Effect of Digitoxin on IL-8 (Interleukin 8) in Induced Sputum in Stable Cystic Fibrosis (CF) Patients.|The Il-8 measurements of sputum digitoxin levels for each group is shown for 5 days (Days 1, 14, 21, 28 and 42).|42 days (Day 1 to Day 42)|Sputum was collected for Il-8 biomarkers on Days 1,14, 21, 28 during the treatment phase and at Day 42. Measures were compared between Baseline, Treatment and Recovery periods to determine if changes from baseline differed between placebo and the two doses.|||log 10 (pg/mL)||Inter-Quartile Range|Median
1459642|NCT00782275|Secondary|Overall Survival|Overall survival (OS) is defined from the date of registration to date of death, or censored at the date the participant was last known alive. OS is estimated based on the Kaplan-Meier method.|Median follow-up for survival in this study cohort is 56 months.|The analysis dataset is comprised of all treated participants.|||months||90% Confidence Interval|Median
1459643|NCT00782275|Secondary|Objective Response Rate|Objective response (OR) rate is the percentage of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment; Treatment continued until disease progression or unacceptable toxicity. Median (range) of treatment duration for this study cohort was 5 cycles (1-39) [1 cycle=28days].|The analysis dataset is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
1459644|NCT00782275|Primary|4-month Progression-Free Survival Rate|4-month progression-free survival rate was defined as the percentage of participants absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment. Relevant for this endpoint was disease status at 4 months.|The analysis dataset is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
1459645|NCT00782210|Secondary|Change From Baseline in Potassium|Laboratory testing: Average change from baseline of potassium measured. The laboratory tests at Day 1 were considered the baseline measurements.|Day 1 and at 12, 24 and 48 weeks|Treated set.|||mmol/L||Standard Deviation|Mean
1459646|NCT00782210|Secondary|Changes in Safety Parameters Related to Treatment|Occurrence of bronchoconstriction, cardiac disorders and investigations related to treatment. Bronchoconstriction is defined as any of the following events: Drop in trough FEV1 >= 15%, Rescue medication use within 30 min of inhaling randomized treatment on a clinic test day or Cough, wheeze, or dyspnoea AE within 30 min of inhaling randomized treatment on a clinic test day.|48 weeks|Treated set.|||percentage of participants|||Number
1459647|NCT00782210|Secondary|Number of Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids.|Baseline to end of study at 48 weeks.||||Number of COPD exacerbations||Standard Error|Mean
1459648|NCT00782210|Secondary|Number of COPD Exacerbations Requiring Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD exacerbations||Standard Error|Mean
1459649|NCT00782210|Secondary|Number of COPD Exacerbations|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria.|Baseline to end of study at week 48 visit|Treated set- all patients who received at least one dose of study medication|||Number of COPD exacerbations||Standard Error|Mean
1459650|NCT00782210|Secondary|Time to First Moderate Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations did not lead to hospitalization but included treatment with antibiotics and/or systemic steroids. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1459651|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. These exacerbations required hospitalization. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1459715|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <100 mg/dL|Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
1463153|NCT00756977|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||mg/dL||Standard Deviation|Mean
1459652|NCT00782210|Secondary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|Qualifying events of COPD were specifically pre-defined in the protocol. Other respiratory related events were evaluated by the investigator to see if they met the pre-defined criteria. Time to event was measured from the beginning of treatment. Cox regression analysis of treatment effect using tiotropium stratum as a stratification factor. Due to the limited number of events some statistics were not able to be calculated and are listed as N/A or are blank. The measure type is the First Quartile.|Baseline to end of study at 48 weeks.|Treated set- all patients who received at least one dose of study medication|||days||95% Confidence Interval|Mean
1459653|NCT00782210|Secondary|Patient's Global Rating at Week 48|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 48 visit|FAS|||Point on scale||Standard Error|Mean
1459654|NCT00782210|Secondary|Patient's Global Rating at Week 24|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 24 visit|FAS|||Point on scale||Standard Error|Mean
1459655|NCT00782210|Secondary|Patient's Global Rating at Week 12|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 12 visit|FAS|||Point on scale||Standard Error|Mean
1459656|NCT00782210|Secondary|Patient's Global Rating at Week 6|Patients were asked to rate their respiratory condition relative to their condition prior to the first dose of study medication. The scale is a seven point scale: 1=very much better, 2=much better,3=a little better,4=no change,5=a little worse,6=much worse,7=very much worst.|Week 6 visit|FAS|||Point on scale||Standard Error|Mean
1459657|NCT00782210|Secondary|Weekly Mean Daily (24h) Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
1459658|NCT00782210|Secondary|Weekly Mean Nighttime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
1459659|NCT00782210|Secondary|Weekly Mean Daytime Rescue Use|The patient was to record in the e-Diary the number of puffs of salbutamol (albuterol) Metered-Dose Inhaler used each day and night.|From Screening to week 48|FAS|||Number of puffs||Standard Error|Mean
1459660|NCT00782210|Secondary|Weekly Mean Evening Peak Expiratory Flow Rate (PEF)|Weekly mean evening peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|at bedtime from Screening to week 48|FAS|||L/min||Standard Error|Mean
1459661|NCT00782210|Secondary|Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEF)|Weekly mean pre-dose morning peak expiratory flow rate (PEF) at 48 weeks. PEFR measurements recorded by means of an e-Diary on a daily basis. This e-Diary was used to record the twice daily PEFs, study drug use, and rescue salbutamol (albuterol) use. The best of three readings for each measurement was recorded.|immediately upon arising (before drug administration) from Screening to week 48|FAS|||L/min||Standard Error|Mean
1459662|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FVC AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1459663|NCT00782210|Secondary|FVC Peak (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1459664|NCT00782210|Secondary|FVC Peak (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459665|NCT00782210|Secondary|FVC Peak (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1465824|NCT00734539|Secondary|Focal Intestinal Perforation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1459666|NCT00782210|Secondary|FVC Peak (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1459667|NCT00782210|Secondary|FVC Peak (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459668|NCT00782210|Secondary|FVC Peak (0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC peak (0-3h) was defined as the mean of the available pre-dose FVC peak (0-3h) values prior to first dose of randomized treatment. FVC Peak (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1459669|NCT00782210|Secondary|Trough FVC Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1459670|NCT00782210|Secondary|Trough FVC Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1459671|NCT00782210|Secondary|Trough FVC Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1459672|NCT00782210|Secondary|Trough FVC Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1459673|NCT00782210|Secondary|Trough FVC Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1459674|NCT00782210|Secondary|Trough FVC Response After 12 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 12 weeks|FAS|||Liter||Standard Error|Mean
1460660|NCT00773474|Primary|Progression Free Survival|To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.|18 months|20 participants were eligible for analysis via the Kaplan-Meier method. PFS assessed via RECIST criteria.|||days||95% Confidence Interval|Mean
1459675|NCT00782210|Secondary|Trough FVC Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1459676|NCT00782210|Secondary|Trough FVC Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FVC was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FVC is defined as the FVCs obtained at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FVCs if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1459677|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1459678|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459679|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1459680|NCT00782210|Secondary|FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1459681|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459682|NCT00782210|Secondary|Forced Vital Capacity (FVC) Area Under Curve 0-3 Hours (AUC 0-3h) Response At Day 1|Response was defined as change from baseline. Baseline FVC was defined as the mean of the available pre-dose FVC values prior to the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect. FVC AUC 0-3h was calculated using the trapezoidal rule, divided by the observation time to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1459683|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1460661|NCT00773461|Secondary|Time to First Remission|Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS<2.6|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Days||95% Confidence Interval|Median
1459684|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459685|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 12 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks|FAS|||Liter||Standard Error|Mean
1459686|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1459687|NCT00782210|Secondary|Peak FEV1 (0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459688|NCT00782210|Secondary|Peak FEV1 (0-3h) Response At Day 1|"Response was defined as change from baseline. Baseline peak FEV1 was defined as the mean of the available pre-dose peak FEV1 values prior to first dose of randomized treatment. Peak FEV1 (0-3h) values were obtained within 0 - 3 hours after treatment.~Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by- visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect."|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at Day 1|FAS|||Liter||Standard Error|Mean
1459689|NCT00782210|Secondary|Trough FEV1 Response After 48 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 48 weeks|FAS|||Liter||Standard Error|Mean
1459690|NCT00782210|Secondary|Trough FEV1 Response After 40 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 40 weeks|FAS|||Liter||Standard Error|Mean
1459691|NCT00782210|Secondary|Trough FEV1 Response After 32 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 32 weeks|FAS|||Liter||Standard Error|Mean
1459692|NCT00782210|Secondary|Trough FEV1 Response After 24 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 24 weeks|FAS|||Liter||Standard Error|Mean
1459716|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goal <77 mg/dL|Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
1459693|NCT00782210|Secondary|Trough FEV1 Response After 18 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 18 weeks|FAS|||Liter||Standard Error|Mean
1459694|NCT00782210|Secondary|Trough FEV1 Response After 6 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 6 weeks|FAS|||Liter||Standard Error|Mean
1459695|NCT00782210|Secondary|Trough FEV1 Response After 2 Weeks|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed a -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug after 2 weeks|FAS|||Liter||Standard Error|Mean
1459696|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 48 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks|FAS|||Liter||Standard Error|Mean
1459697|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 24 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks|FAS|||Liter||Standard Error|Mean
1459698|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 6 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -1h, -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks|FAS|||Liter||Standard Error|Mean
1459699|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response After 2 Weeks|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks|FAS|||Liter||Standard Error|Mean
1459700|NCT00782210|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 1|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose at day 1|FAS|||Liter||Standard Error|Mean
1459717|NCT00782184|Primary|Percent Change From Baseline in Low Density Lipoprotein (LDL)-C||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459701|NCT00782210|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-12 h (AUC 0-12h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a non-mixed effects model with treatment (trt), tio stratum, baseline as fixed effects. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on first day of randomized treatment (baseline) and -1h and -10 min, 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h relative to dose at Day 85 (12 weeks)|Patients in FAS with spirometry data after 3 hours at Visit 5 (12-hour pulmonary function test set)|||Liter||Standard Error|Mean
1459702|NCT00782210|Primary|Trough FEV1 Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation as the end of the dosing interval or the mean of -1h and -10 min FEV1s if both available. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit as fixed categorical effects, baseline and baseline-by-visit as fixed continuous covariates and patient as random effect.|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.|FAS|||Liter||Standard Error|Mean
1459703|NCT00782210|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks)|Response was defined as change from baseline. Baseline FEV1 was defined as the mean of the -1 h and -10 min measurements performed just prior to administration of the first am dose of randomized treatment. Means are adjusted using a mixed effects model with treatment (trt), tio stratum, visit, trt-by-visit interaction as fixed categorical effects, baseline and baseline-by-visit interaction as fixed continuous covariates and patient as random effect. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in litres.|1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85|Full analysis set (FAS). FAS is defined as all randomized patients who received at least one dose of treatment and had both baseline data and at least one post-baseline measurement at or before Day 85 (12 weeks) for either co-primary efficacy variable.|||Liter||Standard Error|Mean
1459704|NCT00782184|Secondary|Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459705|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B/A-1 Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459706|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein A-1||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459707|NCT00782184|Secondary|Percent Change From Baseline in Apolipoprotein B||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459708|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459709|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459710|NCT00782184|Secondary|Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459711|NCT00782184|Secondary|Percent Change From Baseline in Non-HDL Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459712|NCT00782184|Secondary|Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459713|NCT00782184|Secondary|Percent Change From Baseline in Triglycerides||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1459714|NCT00782184|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline (Treatment Day 1), Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
1470388|NCT00706004|Secondary|Serum Sodium||baseline, 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
1459718|NCT00782184|Secondary|Number of Participants Reaching LDL-C Target Goals of <70 mg/dL|Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.|Treatment Week 6|Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available.|||participants|||Number
1459719|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Adverse Events|Number of Adverse Events Number of related/unknown AE Number of related/unknown SAEs Number of Serious Adverse Events (SAEs)|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled|||number of events|||Number
1459720|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|3 years post-surgery||||implants|Number of Implants||Number
1459721|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|2 years post-surgery|The analysis was based on implants as observational unit. The 2-year data was analyzed together with the 3-year data. Our statistical analysis for 2-year time point included how many implants were available but not how many participants.|||implants|Number of Implants||Number
1459722|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|1 years post-surgery||||implants|Number of Implants||Number
1459723|NCT00782171|Secondary|Implant Success|Implant success: An implant was deemed to be successful if there was a lack of implant mobility, absence of any continuous peri-implant radiolucency based on radiographic findings, absence of any recurrent peri-implant infection, absence of continuous or recurrent pain and absence of structural failure of the implant|20-23 weeks post-surgery||||implants|Number of Implants||Number
1459724|NCT00782171|Secondary|Nature and Frequency of Adverse Events (AEs) - Number of Patients Affected|Patients affected by AE Patients affected by related/ unknown AE|until the 3 year post-surgery|All patients who had signed the informed consent form and received a study implant, regardless if all primary and secondary inclusion/exclusion criteria after Implantation were fulfilled|||patients affected|||Number
1459725|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|3 years post-surgery||||implants|Number of Implants||Number
1459726|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|2 years post-surgery||||implants|Number of Implants||Number
1459727|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of Evaluation|1 year post-surgery|Number of implants placed. Implants from drop-outs are not included|||implants|Number of implants||Number
1459728|NCT00782171|Secondary|Implant Survival|Implant survival: An implant was deemed to be surviving, if it was still in place at the time of evaluation|20-23 Weeks post-surgery||||implants|Implants||Number
1459729|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 3 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1459730|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 2 years post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1459731|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 1 year post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1459732|NCT00782171|Primary|Evaluation of Changes in Crestal Bone Levels Evaluated From Standardized Periapical X-rays Comparing the Immediate and Delayed Loading Procedures in Each Group.||Change in crestal bone level from surgery (baseline) to 20-23 Weeks post-surgery|This analysis was based on bone level measurements of implants as observational unit. The final number of units analyzed for the defined period is based on x-rays available at both time points (baseline and follow-up visit). Our statistical analysis of the study data included how many implants were analyzed but not how many participants.|||mm|Implants|Standard Deviation|Mean
1459733|NCT00782067|Secondary|Overall Survival (OS)||5 years|||||||
1459734|NCT00782067|Secondary|Time to Response||5 years|||||||
1459735|NCT00782067|Secondary|Duration of Response||5 years|||||||
1459751|NCT00781937|Secondary|Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||nmol/L||Standard Error|Least Squares Mean
1459736|NCT00782067|Primary|Overall Response Rate (ORR)|The ORR was defined as the percentage of participants who classified as confirmed responders (major response (MR) or partial response (PR). A major responder had complete resolution of at least one C-Finding and no progression in other C-Findings. A partial responder showed a measurable improvement in one or more C-Finding(s) without confirmed progression in other C-Findings. A C-Finding was a Clinical Finding, which was considered by the investigator and corroborated by the Study Steering Committee (SSC) Chairperson or designee, attributable to the mast cell disease component and not the associated hematological clonal non-mast cell lineage disease (AHNMD) component or any other cause.|6 months|Primary Efficacy Population: participants assigned to study treatment who met diagnostic criteria for aggressive systemic mastocytosis or mast cell leukemia and presented with at least 1 measurable C-Finding at study entry and/or participants with transfusion dependent anemia due to their underlying disease at study entry as confirmed by the SCC.|||Percentage of participants|||Number
1459737|NCT00781963|Primary|Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 – 21. A total score > 8 indicates poor sleep quality.|Six months after baseline assessment||||units on a scale||Standard Deviation|Mean
1459738|NCT00781963|Primary|Sleep Efficiency|Calculated from 7-day sleep diary|Six months after baseline assessment|||||||
1459739|NCT00781950|Secondary|Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.||1 year||||mmHg||Standard Error|Mean
1459740|NCT00781950|Primary|Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions||1 year||||participants|||Number
1459741|NCT00781937|Secondary|Binge Eating Scale Scores by Week and Severity|Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)|Week 0, week 50 and week 57|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||scores on a scale||Standard Deviation|Mean
1459742|NCT00781937|Secondary|Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)|Number of subjects using concomitant medications at Week 0 and Week 56, respectively|Week 0 and week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||Subjects|||Number
1459743|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)|Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage point||Standard Error|Least Squares Mean
1459744|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||pmol/L||Standard Error|Least Squares Mean
1459745|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1459746|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)|Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated [X - Y]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median insulin resistance indexed at 1.00.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||proportion||Standard Error|Least Squares Mean
1459747|NCT00781937|Secondary|Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)|Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged <35 years have median beta-cell function indexed at 100%.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percent change||Standard Error|Least Squares Mean
1459748|NCT00781937|Secondary|Change From Baseline in Body Mass Index (BMI)||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg/m^2||Standard Error|Least Squares Mean
1459749|NCT00781937|Secondary|Change From Baseline in Waist Circumference||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||cm||Standard Error|Least Squares Mean
1459750|NCT00781937|Secondary|Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56|Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides >1.7mmol/L; High density lipoprotein cholesterol (men <0.9mmol/L, women <1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.|Week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1466197|NCT00733096|Primary|Numerical Rating Leg Pain Score|0-10 pain score. 0= no pain, 10= worst imaginable pain.|1 month|Patients who received epidural steroid injections|||units on a scale||95% Confidence Interval|Mean
1459752|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Total Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1459753|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1459754|NCT00781937|Secondary|Change From Baseline in Fasting Lipid Profile: Triglycerides|Subjects were tested having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmol/L||Standard Error|Least Squares Mean
1459755|NCT00781937|Secondary|Change From Baseline in Pulse||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||beats/minute||Standard Error|Least Squares Mean
1459756|NCT00781937|Secondary|Change From Baseline in Blood Pressure||Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||mmHg||Standard Error|Least Squares Mean
1459757|NCT00781937|Secondary|Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 68|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg||Standard Error|Least Squares Mean
1459758|NCT00781937|Secondary|Change From Baseline in Fasting Weight|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||kg||Standard Error|Least Squares Mean
1459759|NCT00781937|Secondary|Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1459760|NCT00781937|Secondary|Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1459761|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1459762|NCT00781937|Secondary|Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1459763|NCT00781937|Secondary|Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1459764|NCT00781937|Primary|Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1459765|NCT00781937|Primary|Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0|Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage of subjects|||Number
1459766|NCT00781937|Primary|Mean Percentage Change in Fasting Body Weight From Baseline|Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.|Week 0, week 56|Last Observation Carried Forward, Full Analysis Set (includes all randomised subjects exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.)|||percentage||Standard Error|Least Squares Mean
1459767|NCT00781911|Secondary|Pharmacodynamics Markers; Concentration of Insulin-like Growth Factor I, II (IGF-I, IGF-II), IGF Body Fat (IGFBF)-1 and IGFBF-2||18 months|Zero participants were analyzed due to no data collection due to low number of clinical responses observed.||||||
1459768|NCT00781911|Secondary|Serum Anti-Cixutumumab Antibody Assessment||18 months|Zero participants were analyzed due to no data collection due to low number of clinical responses observed.||||||
1474251|NCT00675103|Primary|Adverse Event Profile|Number of participants reporting events|6 months||||Number of participants|||Number
1459770|NCT00781911|Secondary|PK: Clearance (CL) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1459771|NCT00781911|Secondary|PK: Area Under Concentration (AUCinf) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1459772|NCT00781911|Secondary|PK: Half-life (t 1/2) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1459773|NCT00781911|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1||Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion|Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters.||||||
1459774|NCT00781911|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)|Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|18 months|All participants who had received at least one dose of study drug.|||Participants|||Count of Participants
1459775|NCT00781911|Secondary|Percentage of Participants With a Biochemical Response Rate|Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease.|From Start of Treatment Up to 18 Months|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline Chromogranin A and Gastrin data.|||percentage of participants||95% Confidence Interval|Number
1459776|NCT00781911|Secondary|Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR)|Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions.|From Start of Treatment Baseline to Disease Progression (Up to 18 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1459777|NCT00781911|Primary|Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months|Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method.|From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months)|All participants who received at least one dose of study drug. Participants censored in the carcinoid tumor arm were 8 and in the islet cell carcinoma arm were 4.|||percentage of participants||95% Confidence Interval|Number
1459778|NCT00781898|Primary|Relapse|A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.|6 months||||Participants|||Count of Participants
1459779|NCT00781859|Secondary|Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28|The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.|Day 28|Intention-To-Treat (ITT, Last Observation Carried Forward (LOCF)|||percentage of participants|||Number
1459780|NCT00781859|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.|The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.|Day 28|Intention-To-Treat (ITT), Last Observation Carried forward (LOCF)|||percentage of participants|||Number
1459781|NCT00781768|Primary|Complete Response Rates Among Standard of Care and Combination Therapy Groups.|Comparison of complete response (CR) rates between patients receiving ondansetron and dexamethasone and those receiving ondansetron and dexamethasone plus NK-1 antagonist, aprepitant. CR is defined as no emesis and with normal oral intake. Disease response not applicable.|14 days|179 patients receiving autologous and allogeneic hematopoietic stem cell transplants.|||Participants|||Count of Participants
1459782|NCT00781599|Secondary|Carbon Monoxide-verified Abstinence|Carbon monoxide-verified abstinence determined as a measure of <10 ppm (parts per million). Less than 2ppm CO found in healthy non-smokers.|Month 2|A total of 57 participants completed the month 2 visit. The 15 participants lost to follow-up were treated as smokers for the purposes of data analysis.|||participants|||Number
1459785|NCT00781599|Primary|Percent Compliance With Chantix|Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.|Months 1, 2, 3|Number of participants determined by total number of enrolled participants. For reporting purposes, those participants that did not show up for a visit were treated as smokers.|||Percentage of Participants||Standard Deviation|Mean
1459786|NCT00781508|Secondary|The Distance Walked During the 6-minute Walk Test 1 hr After the Oral Administration of Sildenafil 50 mg.|A standardized course was used to determine the distance walked (meters) during a 6 min walk supervised by a nurse trained in performance of the test.|Measured 1 hr after oral administration of sildenafil 50 mg||||meters||Standard Deviation|Mean
1459787|NCT00781508|Primary|Reduction of the Left Ventricular Filling Pressure in Association With Administration of Sildenafil|Left ventricular filling pressure was assessed by the ratio of the velocity of early mitral inflow (E) divided by the early tissue velocity (e). E/e|Left ventricular filling pressure was assessed 1 hr after oral administration of sildenafil|All patients (10) that completed the protocol were analyzed.|||E/e' ratio||Standard Deviation|Mean
1459788|NCT00781456|Secondary|Mean Number of Days of Bleeding or Spotting|Bleeding and spotting were recorded by participants in the migraine diary during the 91-day treatment period.|91-day treatment period|Safety population with available data|||days||Standard Deviation|Mean
1459789|NCT00781456|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a clinical investigation participant and which does not necessarily have to have a causal relationship with this treatment or clinical study.~The following definitions were used to assess AE severity: Mild: Awareness of signs or symptoms, but they are easily tolerated; Moderate: Enough discomfort to cause interference with usual activity; Severe: Incapacitating, with inability to perform usual activity.~Relationship to study drug was assessed as either: None: Causal relationship can be ruled out; Possibly: Causal relationship at least reasonably possible, i.e. relationship cannot be ruled out; Definitely: Causal relationship is certain.~A serious adverse event (SAE) is one that met any one of the following criteria:~Fatal or life threatening~Requires or prolongs in patient hospitalization~Results in persistent or significant disability/incapacity~Congenital anomaly / birth defect~Important medical event."|Up to 15 weeks|Safety population, consisting of all participants who received at least one dose of study drug.|||participants|||Number
1459790|NCT00781456|Secondary|Change From Baseline in Headache Impact Test|"The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on patients' ability to function on the job, at school, at home and in social situations.~HIT-6 consists of 6 questions each scored on a scale from Never (6 points) to Always (13 points). The total score ranges from 36 to 78 with higher scores indicating greater impact on life.~There was an error in administration of the HIT-6 in this study. Question 6 was not administered, and question 3 from the MIDAS was included instead. Therefore, the total score of the HIT-6 could not be calculated."|Baseline and Week 15|Analysis was not performed due to an error in the administration of the test.||||||
1459791|NCT00781456|Secondary|Change From Baseline in Migraine Disability Assessment|"The migraine disability assessment (MIDAS) test is used to determine how severely migraines affect a patient's life. Participants were asked five questions about how often their headaches limited their ability to go to work or school, to do household work or to do family or leisure activities in the past 3 months.~The MIDAS score equals the sum of the days answered for each question and ranges from 0 (no disability) to approximately 270 (severe disability; the upper bound is dependent on the number of days a participant would plan to work or participate in other activities).~The MIDAS score is classified into four grades of severity:~0 to 5: MIDAS Grade I, Little or no disability~6 to 10: MIDAS Grade II, Mild disability~11 to 20: MIDAS Grade III, Moderate disability~21+: MIDAS Grade IV, Severe disability"|Baseline and Week 15|Intent-to-treat population with available data.|||units on a scale||Standard Deviation|Mean
1459792|NCT00781456|Secondary|Percentage of Participants Who Required Rescue Medications During the Study Period|Participants recorded use of rescue medications for migraines in the migraine diary during the course of study treatment.|Baseline, Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.|||percentage of participants|||Number
1459793|NCT00781456|Secondary|Change From Baseline in Average Migraine Severity|"Migraine severity was recorded by participants in the Baseline qualification diary and study migraine diary during the treatment period. Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication.~Average migraine severity is defined as the sum of the severity ratings divided by the total number of migraine episodes reported during the observation period (for example, Baseline, First Month, Second Month, Third Month, and 91-Day Treatment Period). A negative change from Baseline score indicates improvement in severity."|Baseline and Month 1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time period.|||units on a scale||Standard Error|Least Squares Mean
1459794|NCT00781456|Secondary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the First, Second and Third Months|The percentage of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) compared to Baseline at each month of the treatment period.|Baseline, Month1, Month 2 and Month 3|Intent-to-treat population with available data. N indicates the number of participants with available data at each time point.|||percentage of participants|||Number
1459795|NCT00781456|Primary|Percentage of Participants With ≥ 50% Reduction in Migraine Frequency During the Treatment Period|The number of participants with at least 50% reduction in migraine frequency (average weekly number of migraine episodes) through the end of the 91-day treatment period compared with Baseline (the 25- to 35-day baseline qualification period). Participants recorded the incidence, timing and intensity of migraines in a migraine diary during the prequalification period and throughout the 91-day treatment period.|Baseline (25-35 days before Day 1) and Days 1-91|Intent-to-treat population|||percentage of participants|||Number
1466360|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1459796|NCT00781391|Secondary|Adjudicated Bleeding Events|"Compare edoxaban versus warfarin for Adjudicated Bleeding Events during the on-treatment period in the Safety Analysis set.~Major bleeding was adjudicated by the Clinical Events Committee (CEC) and defined based on published guidance from the International Society on Thrombosis and Haemostasis (ISTH), with minor modifications for Hgb decrease and blood transfusion requirements."|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|Safety-analysis set, on-treatment period|||number of participants with event|||Number
1459797|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality|Compare Edoxaban to warfarin for Composite of stroke, Systemic Embolic Events, and all-cause mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1459798|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding|Compare edoxaban to warfarin for Major Adverse Cardiac Event (MACE): a composite of non-fatal Myocardial Infarction, non-fatal stroke, non-fatal Systemic Embolic Events, and death due to Cardiovascular cause or bleeding during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from the reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1459799|NCT00781391|Secondary|Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality|Compare edoxaban to warfarin for the composite of stroke, Systemic Embolic Events, and Cardiovascular mortality during the overall study period in the ITT analysis set.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; overall study period, which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit..|||number of participants with event|||Number
1459800|NCT00781391|Primary|Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).|Compare edoxaban to warfarin for the composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the ITT analysis set with a superiority analysis.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|ITT (Intent To Treat) Analysis set; which included all randomized subjects whether or not they received a single dose of randomized study drug. The time frame included from reference date (randomization date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1459801|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the PP (per protocol) analysis set population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (per Protocol) Analysis set; which included all randomized subjects who received 1 or more dose of study drug for the overall study period (first dose to end of study) and did not have any major protocol violations. The time period included from the reference date (initial dose of study drug date) to the common study end date (CSED) Visit.|||number of participants with event|||Number
1459802|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the PP (per protocol) analysis set population.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|PP (Per Protocol) Analysis set; which included all randomized subjects who received at least 1 dose of randomized study drug and did not have any major protocol violations. The time period included the time the subject was taking study drug and up to 3 days after their last dose (On Treatment Period).|||number of participants with event|||Number
1459803|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the overall study period in the mITT analysis population.|overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time frame included overall study period (first dose to end of study).|||Number of participants with event|||Number
1459804|NCT00781391|Primary|Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).|The composite of stroke and Systemic Embolic Events (SEE) during the on treatment period in the mITT analysis population with a non-inferiority analysis.|on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up|mITT (modified Intent To Treat) Analysis set; which included randomized subjects who received 1 or more dose of study drug. The time period included the subject was taking study drug and up to 3 days after their last dose (On-Treatment ).|||number of participants with event|||Number
1459805|NCT00781365|Primary|Mean Diastolic Blood Pressure|Mean diastolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months||||mm Hg||95% Confidence Interval|Mean
1459806|NCT00781365|Primary|Mean Systolic Blood Pressure|Systolic blood pressure at baseline and 4 time points|Baseline, 6 months, 12 months, 18 months, 54 months||||mmHg||95% Confidence Interval|Mean
1459807|NCT00781365|Primary|Blood Pressure Control|Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)|Baseline, 6 months, 12 months, 18 months||||percentage of participants||95% Confidence Interval|Number
1459808|NCT00781326|Primary|Hamilton Depression Rating Scale (24 Item) [Phase I Primary Outcome]|Hamilton Depression Rating Scale (24 item) measures symptoms of major depression. We report total score which is the sum of all items. Total score range is 0 to 76 with higher scores indicating more severe depression. We reports scores at end of Phase I for subjects completing the phase.|End of Phase I (at 24 weeks)||||units on a scale||Standard Deviation|Mean
1475688|NCT00663403|Secondary|Daptomycin Dose Actually Administered||Time of daptomycin administration||||mg/kg||Standard Deviation|Mean
1459810|NCT00781079|Secondary|Quality of Life Interview, Brief Version|Subjective ratings of overall quality of life and the quality of social relationships, daily life, and family interactions was assessed using a combination of selected scales from the Quality of Life Instrument-Brief Version (QOLI), which been used extensively with a wide range of populations including those who are homeless, have a dual diagnosis, and are ethnic minorities. Because of low internal consistencies of subscales in our sample, a factor analysis was conducted which indicated that a larger scale that included the items from the overall quality of life, social relationships, daily life, and family interactions scales would be more reliable.|immediately before the intervention (BL), and 12 months post intervention (Post).|||||||
1459811|NCT00781079|Secondary|Illness Management and Recovery Scale: Client Self-Rating||12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).|||||||
1459812|NCT00781079|Secondary|Recovery Self-Assessment: Person in Recovery Version|Perceptions of the recovery orientation of the program were assessed with the Recovery Self-Assessment (RSA), a 36 item survey that assesses domains of recovery-orientated practice (e.g., focus on life goals, involvement of patients in their own care). The RSA has high internal consistency and is thought to represent a more recovery-oriented or recovery-supportive environment.|immediately before the intervention (BL), and 12 months post intervention (Post)|||||||
1459813|NCT00781079|Secondary|Patient Activation Measure|The mental health version of the Patient Activation Measure (PAM) is a single 13-item scale designed to assess patient’s knowledge, skill, and confidence in health self-management. Respondents endorse items (e.g., “I know what each of my prescribed medications do”) on a scale from 1 (“disagree strongly”) to 4 (“agree strongly”). Raw scores are converted using the established methodology for the PAM to an activation score from 0 (lowest)-100 (highest). Identifying levels of activation is based on whether an activation score falls within a previously determined range of scores. Level 1, the lowest level of activation, includes activation scores of 47 or lower; Level 2 includes scores of 47.1 to 55.1; Level 3 includes scores of 55.2 to 67.0; and Level 4 (the highest activation level) includes scores of 67.1 or above. This version has similar psychometric properties as the original 13-item PAM and correlates with related constructs in other samples of people with SMI.|immediately before the intervention (BL), and 12 months post intervention (Post).||||units on a scale||Standard Deviation|Mean
1459814|NCT00781079|Secondary|Mental Health Recovery Measure (MHRM)|The Mental Health Recovery Measure (MHRM) is a 30-item, 5-point behaviorally-anchored self-report measure based upon recovery experiences of persons with psychiatric disabilities. The MHRM total score has good validity, correlating strongly with the Empowerment Scale and Community Living Skills Scales, yet assessing unique aspects of recovery.|immediately before the intervention (BL), and 12 months post intervention (Post).|||||||
1459815|NCT00781079|Primary|BASIS-R|The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96).|immediately before the intervention (BL), and 12 months post intervention (Post).||||units on a scale||Standard Deviation|Mean
1459816|NCT00780962|Primary|Number of Participants With Contrast-induced Nephropathy|Contrast-induced nephropathy was defined as an increase in serum creatinine level of greater than or equal to 0.5 mg/dL or an increase of 25% above baseline. The primary outcome was measured by the change in serum creatinine level from the pre-radiocontrast baseline to the serum creatinine level measured 48 to 72 hours after radiocontrast administration.|48-72 hours|Out of 399 subjects who consented to participate in the study, only 357 (89.4%) had a second blood creatinine levels measurement done between 48 to 72h.|||Participants|||Count of Participants
1459817|NCT00780910|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1459818|NCT00780741|Secondary|Proportion of Participants With Office Probing Success 6 Months After Randomization|The proportion of immediate office group participants whose office probing was successful when assessed 6 months after randomization. Office probing success was defined as absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) 6 months after randomization and no reoperation.|Randomization to 6 months|Participants randomized to immediate office probing who underwent office probing.|||proportion with treatment success||95% Confidence Interval|Number
1459819|NCT00780741|Secondary|Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon unmasked examination 6 months after randomization. Participants who were operated before the 6-month visit were considered treatment failures.|Randomization to 6 months|All participants who had unilateral nasolacrimal duct obstruction at baseline, who were randomized to the deferred facility probing group, and who completed the 6-month visit (timed from randomization). The analysis followed the intent to treat principle.|||proportion of participants||95% Confidence Interval|Number
1459820|NCT00780741|Secondary|Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age|Months of NLDO symptoms between randomization and 18 months of age. When resolution of NLDO occurred without surgery, the time of resolution was estimated as the midpoint between randomization and the first time point at which symptoms/signs were reported as absent (i.e. 3-month phone call, 6-month visit, or 18 months of age visit) without a subsequent report of symptoms/signs. For patients who underwent successful surgery, months of symptoms was estimated as months between randomization and the surgery. Patients who had clinical signs present at the 18 month of age visit were considered to have had symptoms present since randomization.|Randomization to 18 months of age.|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.|||months of symptoms||Full Range|Mean
1460232|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure|Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1459821|NCT00780741|Primary|Cost of Treatment|Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.|Randomization to 18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the visit at 18 months of age were analyzed. The analysis followed the intent to treat principle.|||US dollars||Full Range|Mean
1459822|NCT00780741|Primary|Proportion of Participants With Treatment Success|Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.|18 months of age|All participants who had unilateral nasolacrimal duct obstruction at baseline and who completed the primary outcome visit at 18 months of age were analyzed. The analysis followed the intent-to-treat principle.|||proportion of participants|||Number
1459823|NCT00780715|Primary|HbA1c Change|Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)|6 months|Modified Intention to treat|||absolute change in %HbA1c||Standard Deviation|Mean
1459824|NCT00780676|Primary|Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)|Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.|Tumor status assessed every 8 weeks during therapy, up to 6 months|Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to either group, and only treated participants (30) included in analysis.|||Percentage of Participants|||Number
1459825|NCT00780572|Primary|Time to Intervention Once an ADE Alert Has Fired in CPRS||From the time an ADE alert fires in CPRS until the time action has been taken, i.e. an order placed, up to 24 hours.||||hours to intervention||Inter-Quartile Range|Median
1459826|NCT00780481|Secondary|Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.||Single Study Day|Data was lost||||||
1459827|NCT00780481|Secondary|Radial Artery Elasticity||Single Study Visit|Data was lost||||||
1459828|NCT00780481|Secondary|Peak FMD||Single Study Day|Data Lost||||||
1459829|NCT00780481|Primary|Peak t-PA Release|tPA Release|Single Study day|Data was lost||||||
1459830|NCT00780455|Secondary|Quality of Life Assessed by Use of Self-questionnaire (SEP-59)|SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459831|NCT00780455|Secondary|Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)|FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|From baseline to 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459832|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits|"Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459833|NCT00780455|Secondary|Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit|Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459834|NCT00780455|Secondary|Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit|The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.|At baseline and 12 weeks after MR1 visit|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459835|NCT00780455|Secondary|Covered Distance Gain Between MR2 Visit and MR3 Visit|"Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization."|At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459836|NCT00780455|Primary|Rhythm Change During 6 Minutes Walking Test||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459837|NCT00780455|Primary|Distance of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459838|NCT00780455|Primary|Time of Discomfort Appearance||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459839|NCT00780455|Primary|Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.||Up to 6 minutes|Due to the very low number of patients enrolled in the study, no statistical report was done.||||||
1459840|NCT00780442|Primary|Cocaine Craving Scale|"Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS. Subjects rate craving on a scale from 0-10 with 0 indicating Not at all and 10 indicating Extremely."|Immediately following cue exposure|Cocaine dependent individuals|||Units on a scale||Standard Deviation|Mean
1459841|NCT00780416|Primary|The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
1459842|NCT00780403|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).|||participants|||Number
1459843|NCT00780338|Secondary|Prevention Performance - Total Score (Percent Change)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. Percent change was calculated from Pre to Mid, Mid to Post, PRE to POST.|||percent change||Full Range|Mean
1459844|NCT00780338|Secondary|Prevention Capacity - Assets Efficacy (User vs Non-user Analyses)|"The Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing assets activities. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"|||percentage of the highest possible score||Standard Error|Least Squares Mean
1459845|NCT00780338|Primary|Prevention Capacity-Assets Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. Assets efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the Developmental Assets model. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid (1 year), post (2 years)|Despite drop outs, all the data was used.|||percentage of the highest possible score||Standard Deviation|Mean
1460662|NCT00773461|Secondary|Time to First Low Disease Activity|Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Days||95% Confidence Interval|Median
1459846|NCT00780338|Secondary|Prevention Capacity - Assets Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
1459847|NCT00780338|Primary|Prevention Capacity - ASSETS Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in assets activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
1459848|NCT00780338|Primary|Prevention Capacity - ASSETS GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
1459849|NCT00780338|Secondary|Prevention Capacity - ASSETS GTO BEHAVIORS (User vs Non-user Analyses)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
1459850|NCT00780338|Secondary|Prevention Capacity - GTO Efficacy (User vs Non-user Analyses)|"The GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index."|Baseline, Mid (1 year), Post (2 years)|"Users had a AGTO Participation Index >=1 at either Mid or Post; Non Users had a AGTO Participation Index = 0"|||percentage of the highest possible score||Standard Error|Least Squares Mean
1459851|NCT00780338|Secondary|Prevention Capacity - GTO Behavior - (User v Non-User Analysis)|"This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in GTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale. Same analysis/measure as the intent to treat, but instead just comparing users of AGTO to non-users within the AGTO assigned group. Use was determined by six items added to the Mid and Post Coalition Survey, called the AGTO Participation Index. If individuals received any hours of technical assistance, they received an additional point on the Index. Then, a dichotomous measure was created if a user participated (AGTO Participation Index >=1) at either Mid or Post."|Baseline, Mid (1 year), Post (2 years)||||percentage of the highest possible score||Standard Error|Least Squares Mean
1459852|NCT00780338|Primary|Prevention Capacity - GTO Behaviors (Intent to Treat)|This scale is the sum of 11 items with seven-point scales (1=“never” to 7=“very often”) assessing the frequency with which respondents engaged in AGTO activities during the previous 12 months. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .06 change on the original 1–7 scale. A 17-percentage point change would be equivalent to a one-point change on the original 1–7 scale.|Baseline, Mid (1 year), Post (2 years)|Intent to Treat|||percentage of the highest possible score||Standard Error|Least Squares Mean
1459870|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Volume|GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device. GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above.|week 8 and week 12||||ul||Standard Deviation|Mean
1466361|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1459853|NCT00780338|Secondary|Prevention Performance - Total Score (Descriptive Means)|A structured interview was used to assess the impact of AGTO on prevention practitioners' performance of tasks associated with high-quality prevention. Using the interview responses, a set of ratings were made assessing performance of activities in seven key domains: goals and objectives, best practices, planning, process evaluation, outcome evaluation, continuous quality improvement, and sustainability. The ratings are made on 10 items (or “components”) that assess how well each of the above mentioned activities are performed over the last year. Each component has seven response choices, described with specific, observable behaviors, that range from “highly faithful=7” to “highly divergent=1” from ideal performance. The total score is an average of the 10 components, and has the same range as the individual components (“highly faithful=7” to “highly divergent=1” from ideal performance)|baseline, baseline to mid (1 year), mid to posttest (2 years)|Whole programs are rated, not individuals, because programs operate as a unit. These means are presented at the timepoints in which they were collected.|||units on a scale|Participants|Full Range|Mean
1459854|NCT00780338|Primary|Prevention Capacity-GTO Efficacy (Intent to Treat)|Assessed in the Coalition Survey, prevention capacity was defined as efficacy and behaviors of practitioners. GTO efficacy scale is the sum of 10 items using a three-point scale (1=“would need a great deal of help to carry out this task”, 2=“could carry out this task, but would need some help”, 3=“could carry out this task without any help”) asking about activities associated with doing the AGTO 10 steps. The sum was then transformed to be on a 1–100% scale. A percentage point change is equivalent to a .02 change on the original 1–3 scale. A 50-percentage point change would be equivalent to a one-point change on the original 1–3 scale.|Baseline, mid-point (1 year), posttest (2 years)|Despite drop outs, all the data was used.|||percentage of the highest possible score||Standard Deviation|Mean
1459855|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|24 months after surgery||||Percentage of implants|Participants||Number
1459856|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|12 months after surgery||||Percentage of implants|Participants||Number
1459857|NCT00780273|Primary|Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level|Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.|6 months after surgery||||Percentage of implants|Participants||Number
1459858|NCT00780208|Secondary|Number of Participants With Positive Drug Screen|Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens|8 weeks||||Participants|||Count of Participants
1459859|NCT00780208|Primary|ADHD Symptom Severity|Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).|Baseline, Week 8||||units on a scale||Standard Deviation|Mean
1459860|NCT00780026|Secondary|Incidence of Venous Thrombotic Complications|Number of participants who were diagnosed with portal vein thrombosis post surgery|12 months||||participants|||Number
1459861|NCT00780026|Secondary|Incidence of Biliary Complications|Number of participants who experienced bile leak or biliary Stricture|12 months||||participants|||Number
1459862|NCT00780026|Secondary|Need for Hemodialysis|Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it;|12 months post surgery||||participants|||Number
1459863|NCT00780026|Secondary|Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU|Requirements for blood transfusion counted as a binary variable yes/no per participant|12 months||||participants|||Number
1459864|NCT00780026|Secondary|Hospital Length of Stay||12 months||||days||Standard Deviation|Mean
1459865|NCT00780026|Primary|One Year Survival Post Transplant||12 months||||participants|||Number
1459866|NCT00780026|Primary|Infection Rates|Number of participants who sustained an infection after surgery|30 days||||participants|||Number
1459867|NCT00779909|Secondary|Urinary Calcium/Creatinine Ratio|Urinary calcium ratios were calculated from urine samples at week 4, 7, and 12. A normal reference interval for the urine calcium (mg/dL):urine creatinine (mg/dL) ratio is <0.14.|week 4, week 7, week 12||||ratio||Standard Deviation|Mean
1459868|NCT00779909|Secondary|Serum Calcium|The serum calcium blood test measures the total calcium in the participants' blood. The normal range for total serum calcium concentration in adults is 8.9-10.2 mg/dL.|week 7, week 12||||mg/dl||Standard Deviation|Mean
1459869|NCT00779909|Secondary|Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12|"GCF will be collected by placing a filter paper strip at the opening of the gingival crevice. After carefully removing the supragingival plaque from the sampling area, a paper strip will be placed for 30s or until visibly wet. Sampling time will be recorded and GCF volume collected with each sample will be quantified using a Periotron device.~GCF volume will be sampled from three mesial sites per subject: The upper left central incisor, the first upper left premolar and the first upper left molar. Should any of these teeth be missing, substitution will occur in the following order (i) the contralateral tooth, (ii) the distally adjacent tooth, or (iii) the distally adjacent tooth of the contralateral tooth. Should a sample be visibly contaminated with blood, the sample will be discarded and substitution will occur as described above. Concentrations of TNF-alpha, IL-1 beta, IL-2, and IL-12 will be measured and means and SDs will be calculated for each study arm."|week 8 and week 12||||pg/site||Standard Deviation|Mean
1459880|NCT00779779|Secondary|Number of Subjects Reporting Each Type of Solicited General Symptoms|Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.|During the 8-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1506260|NCT00425269|Secondary|Systolic Blood Pressure, Baseline||baseline||||mmHg||95% Confidence Interval|Mean
1459871|NCT00779909|Secondary|Maxillary Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1459872|NCT00779909|Secondary|Mandibular Plaque Index (PI) Score|The Turesky plaque index was used. In this index, plaque is identified using a disclosing solution and scored using a 0 to 5 scale in which a score of 0= No plaque, 1= Separate flecks of plaque, 2= continuous band of plaque less or equal 1 mm, 3= Continuous band of plaque greater than 1 mm but less than 1/3 of crown height, 4= Continuous band of plaque greater or equal 1/3 but less or equal 2/3 of crown height, and 5= Continuous band of plaque greater 2/3 of crown height. Each tooth receives 6 individual scores at: mesial, middle, and distal scores for both the facial and lingual surfaces. An individual’s score is derived by adding the scores at each site and dividing by the number of sites evaluated. Higher scores denote higher plaque accumulation. Lower scores are more favorable.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1459873|NCT00779909|Primary|Maxillary Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1459874|NCT00779909|Primary|Mandibular Modified Gingival Index (MGI) Score|The Modified Gingival Index (MGI) uses non-invasive/no probing and rates mild and moderate inflammation where: 0 = absence of inflammation; 1 = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary; 2 = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration. The MGI can be obtained by adding the values of each tooth and dividing by the number of teeth examined. The MGI may be scored for all surfaces of all or selected teeth or for selected areas of all or selected teeth. A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation from, and 2.1-3.0 signifies severe inflammation.|week 8 and week 12||||units on a scale||Standard Deviation|Mean
1459875|NCT00779909|Primary|Proportion of Sites That Bleed on Probing|Assessment of the bleeding index will be performed on oral and buccal sites. The periodontal probe will be moved gently across the marginal gingiva of all teeth of a quadrant. After 30 seconds, absence or presence of bleeding will be scored. The number of bleeding sites is used to calculate the gingival bleeding score.|end of 4 week experimental gingivitis phase|Data for this outcome measure was not collected on any of the participants as it was overlooked and failure to collect these data did not come to the attention of the PI until after all follow-ups were completed.||||||
1459876|NCT00779857|Primary|Percent of Patients With Complete Occlusion of the Left Atrial Appendage.|The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.|3 Months Post Procedure|The primary analysis population for the efficacy endpoint is all patients enrolled into the trial who complete the intended treatment and the required post procedure and follow-up efficacy endpoint assessments (completers). All available data, regardless of whether data are derived within specified time windows, will be included in this analysis.|||percentage of subjects||95% Confidence Interval|Number
1459877|NCT00779857|Primary|Rate of Device Related Serious Adverse Events|The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.|Discharge/30 days Post Procedure|The primary analysis population is all patients enrolled in the trial. All available data, regardless of whether data are derived within specified time windows will be included in the analysis. Patients who do not complete the entire course of treatment will be included.|||Number of participants||95% Confidence Interval|Number
1459878|NCT00779779|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject|Throughout the study period (Day 0 to Month 3 or 4)|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1459879|NCT00779779|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1459946|NCT00779558|Secondary|Total PRBCs Transfused||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||mL/kg||Standard Deviation|Mean
1459881|NCT00779779|Primary|"Number of Subjects With at Least One >= Grade 2 Fever, Vomiting or Diarrhoea"|"Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.~Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.~Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day."|During the 8-day solicited follow-up period|Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
1459882|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459883|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Live infant CA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459884|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Elective termination CA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth CA, Lost to follow up, Molar pregnancy, Pregnancy ongoing. For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459885|NCT00779766|Secondary|Number of Subjects With Pregnancies and Their Outcomes|"Outcomes of pregnancies were Live infant NO ACA, Premature live infant NO ACA, Elective termination NO ACA, Therapeutic abortion, Ectopic pregnancy, Spontaneous abortion NO ACA, Spontaneous abortion CA, Stillbirth congenital anomaly, Lost to follow up, Molar pregnancy and Pregnancy ongoing.~For some categories it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA)."|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459886|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459887|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459888|NCT00779766|Secondary|Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459889|NCT00779766|Secondary|Number (%) of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459890|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1463154|NCT00756977|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent"|2-day||||percentage of participants||95% Confidence Interval|Number
1459891|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459892|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459893|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459894|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0°C).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459895|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459896|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459897|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459898|NCT00779766|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|up to Months 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459899|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)|"An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity"|Within Days 0-29 after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459900|NCT00779766|Secondary|Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity.|Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|up to Months 24 and 72|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459947|NCT00779558|Primary|Thrombosis|Echocardiographic evidence of thrombosis while on study drug|While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days||||participants|||Number
1459901|NCT00779766|Secondary|Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius).~Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = prevented normal activity Grade 3 urticaria = distributed on at least 4 body areas"|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459902|NCT00779766|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling = swelling above 50 millimeter All local symptoms were considered as related to the study vaccination|Within 7 days (Days 0-6) after vaccination|The Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
1459903|NCT00779766|Secondary|Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status|"Titers were expressed as geometric mean titers calculated on all subjects HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at Months 0, 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72.~HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at Month 0, 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Months 36, 48 and 72..~Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above the assay cut-off value prior to vaccination."|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1459904|NCT00779766|Secondary|Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 18 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL and 18 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subjects|||Number
1459905|NCT00779766|Secondary|Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status|HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and greater than or equal to 19 ELISA units per millilitre (EL.U/mL) at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.|at Months 0 (PRE), 7, 12, 24, 36, 48 and 72|The According-To-Protocol cohort for immunogenicity for the interim analysis included only data up to Month 7 of subjects from the immunogenicity subset (795 subjects recruited exclusively from one site). This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subjects|||Number
1459906|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459907|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type|"CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459908|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection|CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459909|NCT00779766|Secondary|Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection|"CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.~DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459910|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).~Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459911|NCT00779766|Secondary|Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection|"Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~US)."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459912|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459913|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459914|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type|"Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.~HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459915|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18|"Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months.~Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA).~Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459948|NCT00779506|Secondary|Global Assessment of Functioning (GAF) Score|To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1460309|NCT00775528|Primary|Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)|Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.|10 Days||||Participants|||Number
1459916|NCT00779766|Secondary|Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18|"Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months.~Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459917|NCT00779766|Secondary|Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18|"HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered.~DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)~Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus."|At Months 24,48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459918|NCT00779766|Primary|Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18|"CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer.~Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at Months 0 and 6 and seronegative at Month 0 or on subjects DNA- at Months 0 and 6, regardless of initial serostatus."|At Months 24, 48, 57 and 72|The According-To-Protocol cohort for efficacy included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.|||Subjects|||Number
1459919|NCT00779701|Primary|Time to Achieve Glycemic Control||Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.||||Minutes||Standard Deviation|Mean
1459920|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline..|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1459921|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1459922|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1460310|NCT00775528|Secondary|Total Calorie Intake (kcal)|The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Kcal||Standard Deviation|Mean
1459923|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1459924|NCT00779675|Secondary|Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1459925|NCT00779675|Secondary|Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as >=25%, >=50%, >=75%, >=90%, =100% improvement in PASI score versus baseline, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase with at least one PASI evaluation during the extended treatment phase.|||Participants|||Number
1459926|NCT00779675|Secondary|Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at each time point.|||Participants|||Number
1459927|NCT00779675|Secondary|Change From Baseline in Mean Dermatology Life Quality Index (DLQI)|The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.|Baseline, Week 50, Week 62, Week 78, Week 98|The population consisted of all participants with a DLQI measurement at baseline and at each time point.|||Score on a Scale||Standard Error|Mean
1459928|NCT00779675|Secondary|Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase|PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at >=90% and >=75% improvement in overall PASI score when compared to baselne, respectively.|Week 98|The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase and had a PASI-75 response at Week 50 with at least one PASI evaluation during the extended treatment phase.|||Participants|||Number
1459949|NCT00779506|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1459929|NCT00779675|Secondary|Change From Baseline in Mean PASI Score|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.|Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98|The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 98.|||Score on a Scale||95% Confidence Interval|Mean
1459930|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline, respectively.|Week 98|The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase.|||Participants|||Number
1459931|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period|Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as >=90% improvement in overall PASI score when compared to baseline.|Week 98|The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase.|||Participants|||Number
1459932|NCT00779675|Secondary|Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as >=50%, >=75%, >=90% improvement in PASI score versus baseline.|Week 50|The population includes all participants that achieved a PASI-50 response at treatment Week 14.|||Participants|||Number
1459933|NCT00779675|Secondary|Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14|Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as >=90% improvement and a >=75% improvement, respectively, in overall PASI score when compared to baseline.|Week 50|The population consists of all participants that achieved PASI-75 response by treatment Week 14.|||Participants|||Number
1459934|NCT00779675|Secondary|Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as >= 90% improvement when compared to baseline.|Week 50|The population consists of all participants that achieved a PASI-90 response at treatment Week 14.|||Participants|||Number
1459979|NCT00779142|Secondary|Number of Participants With Increase in Visual Acuity (VA) Two Lines or More at the End of One Month After the Last Intraocular Injection||1 month||||Participants|||Count of Participants
1506261|NCT00425269|Secondary|Triglycerides, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1459935|NCT00779675|Primary|Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50|Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as >=75% improvement in overall PASI score when compared to baseline.|Week 50|The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.|||Participants|||Number
1459936|NCT00779584|Secondary|MK-8776 Terminal Phase Half-Life (t1/2)|The t1/2 of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||hr||Standard Deviation|Mean
1459937|NCT00779584|Secondary|Time of MK-8776 Cmax (Tmax)|The time of Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||hr||Standard Deviation|Mean
1459938|NCT00779584|Secondary|MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)|AUC0-last was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion. AUC0-last was calculated by the linear trapezoidal method.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||ng*hr/mL||Standard Deviation|Mean
1459939|NCT00779584|Secondary|MK-8776 Maximum Plasma Concentration (Cmax)|The Cmax of MK-8776 was assessed in Cycle 0 and in Cycle 1. On Day 1 of Cycle 0 and Cycle 1, plasma samples were obtained from all participants before infusion, at end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion.|At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion|The population consisted of all participants who received at least two cycles of study treatment.|||ng/mL||Standard Deviation|Mean
1459940|NCT00779584|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximatey 66 weeks|The population consisted of all participants who received at least one dose of MK-8776.|||Participants|||Number
1459941|NCT00779584|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could have been any unfavorable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to study treatment. The number of participants who experienced an AE is presented.|Up to approximately 72 weeks (Up to approximately 6 weeks after last dose of study treatment)|The population consisted of all participants who received at least one dose of MK-8776.|||Participants|||Number
1459942|NCT00779584|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)|During Cycle 0, a DLT was defined as: CTCAE v 3.0 Grade 3 neutropenia or thrombocytopenia lasting ≥3 days; any CTCAE v 3.0 Grade 4 neutropenia or thrombocytopenia; neutropenic fever; any CTCAE v. 3.0 ≥ Grade 3 QT interval corrected by Fridericia (QTcF) prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s); delay in Cycle 1 Day 1 beyond 3 weeks due to continuing toxicity. During Cycle 1, a DLT was defined as: CTCAE v 3.0 Grade 4 neutropenia that persists for ≥7 days; neutropenic fever; CTCAE v 3.0 Grade 4 thrombocytopenia; CTCAE v 3.0 ≥ Grade 3 thrombocytopenia with bleeding; any CTCAE v 3.0 QTc ≥ Grade 3 QTcF prolongation of any duration; any other CTCAE v 3.0 Grade 3 or higher nonhematologic toxicity; or Grade 3 elevation of transaminases that resolved prior to administration of next dose(s) of study drug(s).|Through Cycle 0 and Cycle 1 (Up to 42 days)|The population consisted of all participants who were evaluable for DLT assessment (i.e., completed Cycle 0 and Cycle 1).|||Participants|||Number
1459943|NCT00779558|Secondary|Need for Antibiotics||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||participants|||Number
1459944|NCT00779558|Secondary|Cardiac ICU Length of Stay||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||days||Standard Deviation|Mean
1459945|NCT00779558|Secondary|Days to Extubation||While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)||||days||Standard Deviation|Mean
1459950|NCT00779506|Secondary|Clinical Global Impression (CGI) Score|The Clinical Global Impression – Severity (CGI-S) and – illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient’s current clinical state. The CGI-I is scored to rate the patient’s change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1459951|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score|To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1459952|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Negative Score|To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1459953|NCT00779506|Secondary|Positive and Negative Syndrome Scale (PANSS) Positive Score|To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1459954|NCT00779506|Primary|The Change in Positive and Negative Syndrome Scale(PANSS)Total Score|"PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 – 210.~Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method"|From baseline to Day 57|The MITT set was used for primary analyses (89) participants|||score on a scale||Standard Deviation|Mean
1459955|NCT00779467|Secondary|Cesarean Delivery|percentage of subjects in each group requiring a ceserean delivery|occurence||||percentage of subjects in each group|||Number
1459956|NCT00779467|Secondary|Patient Satisfaction Scores|maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia|within 24 hours post delivery||||units on a scale||Inter-Quartile Range|Median
1459957|NCT00779467|Secondary|Bromage Score|the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)|until delivery|Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)|||units on a scale||Standard Deviation|Mean
1459958|NCT00779467|Secondary|Pruritus|the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.|until delivery|the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.|||units on a scale||Standard Deviation|Mean
1459959|NCT00779467|Secondary|Shivering|maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably|until delivery||||units on a scale||Standard Deviation|Mean
1459960|NCT00779467|Secondary|Sedation|average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy|until delivery||||units on a scale||Standard Deviation|Mean
1459961|NCT00779467|Secondary|Nausea|average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable|until delivery||||units on a scale||Standard Deviation|Mean
1459962|NCT00779467|Primary|Amount of Drug Consumed Per Hour in Each Group(Arm)|Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)|until delivery|median hourly total bupivacaine consumption in each group, in ml/hr|||milliliters per hour||Inter-Quartile Range|Median
1459963|NCT00779402|Primary|Number of Subjects That Met Biochemical Failure Status|time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.|Every 3 months post-infusion||||Participants|||Count of Participants
1459964|NCT00779402|Primary|Time to Biochemical Failure Cumulative Incidence Percentile|Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL|Every 3 months post-infusion|Number of subjects that met biochemical failure criteria.|||Months||95% Confidence Interval|Median
1459965|NCT00779311|Secondary|Determination of Quality of Life (QoL) as Indicated by Patient Care Monitor (PCM) Data Among Patients on This Regimen|The subject answers questions from the following 6 categories: general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation. Each question has a scale from 0 through 10, where 0 is not a problem and 10 is as bad as possible. The frequency of patient reported severe (rated as >=7) symptoms reported from the set of symptoms assessed by the PCM.|The PCM questionnaire was administered on day 1 of each cycle (approximately every 2 weeks) during study treatment.|The number of patients out of the total sample of 8 patients who reported severe (rated as >=7) symptoms as assessed by the PCM. Symptoms with 0 patients reporting severe symptoms have been omitted.|||Participants|||Number
1459966|NCT00779311|Secondary|Determination of Progression Free Survival (PFS) Among Patients on This Regimen|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first.||||Months||95% Confidence Interval|Median
1459980|NCT00779142|Primary|30% Decrease in One Subfield Thickness on Optical Coherence Tomography (OCT) 4 Weeks After the Last Intraocular Injection||4 weeks||||participants|||Number
1463207|NCT00756275|Secondary|Percent Smoking Days||6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of days||Standard Deviation|Mean
1459967|NCT00779311|Primary|Determination of the Maximum Tolerated Dose (MTD) of Sorafenib When Given in Combination With mFOLFOX6 and Bevacizumab|The MTD of sorafenib was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose depends on the frequency of dose limiting toxicities (DLT) at each dosage. If 0 out of 3 patients experience a DLT at a given dosage level, 3 patients will be enrolled at the next dosage level. If greater than or equal to 2 patients experience a DLT at a given dosage level, dosage escalation will be stopped. If 1 out of 3 patients experience a DLT at a given dosage level, 3 patients are enrolled at the same dosage level.|MTD was assessed during the first 2 cycles of treatment (i.e., the first 4 weeks of treatment since cycle length is 2 weeks)|3 patients (pts) were enrolled at DL 1 with 1/3 experiencing DLT, so 3 additional pts were enrolled at DL 1. 2 of those additional pts were not evaluable for DLT assessment and were replaced. 2 more pts were enrolled for a total of 8 pts, and 1 of these pts experienced a DLT. All of the 8 pts enrolled received sorafenib at DL 1.|||mg every other day|||Number
1459968|NCT00779285|Primary|Cardiac Events|A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).|Every 4 weeks during 6 cycles.||||Cardiac Events|||Number
1459969|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Theophylline Co-administered With Quinine, Study Day 12.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours post-dose on Day 12||||msec|||Number
1459970|NCT00779259|Secondary|Electrocardiogram (ECG) Evaluation of the Maximum QT Interval Corrected for Heartrate (QTc), Quinine Study Day 11.|The QT interval assesses cardiac repolarization and risk for arrhythmias. It is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc is the QT interval corrected for heartrate.|5 hours - measured 1 hour pre-dose and then at 4 hours after the morning dose on Day 11||||msec|||Number
1459971|NCT00779259|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)].|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞)was calculated as the sum of the AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug-hr/mL||Standard Deviation|Mean
1459972|NCT00779259|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve beginning from the first dose (time 0) to the last measurable concentration (time t), as calculated by the linear trapezoidal method.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug-hr/mL||Standard Deviation|Mean
1459973|NCT00779259|Primary|Maximum Plasma Concentration(Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|Serial pharmacokinetic blood samples for theophylline collected on Days 1 and 12 before dosing and for 48 hours post-dose. Serial pharmacokinetic blood samples for quinine collected on Days 11 and 12 before dosing and for 8 hours after the morning dose.|A total of 24 healthy adult male subjects participated in this study, 22 of whom completed. Pharmacokinetic analyses of theophylline are based on 19 subjects (data for 2 subjects excluded due to vomiting post-dose and for 1 subject as an outlier. Pharmacokinetic analyses of quinine are based on 20 subjects (excluding the two who vomited).|||ug/mL||Standard Deviation|Mean
1459974|NCT00779246|Secondary|Vancomycin Resistant Enterococcal Infection or Colonization||During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||Participants|||Count of Participants
1459975|NCT00779246|Secondary|Number of Participants With Central Line Associated Bloodstream Infection||During ICU stay up to six months|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||participants|||Number
1459976|NCT00779246|Primary|Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection|Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).|During ICU stay|For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.|||participants|||Number
1459977|NCT00779155|Primary|"Change From Baseline to Study End Point in the Combined Scores From the UPDRS Subscale II and III Recorded in the Subjects on State."|The UPDRS is used to measure different aspects of Parkinson's Disease (PD). The UPDRS subscale II assesses how PD affects a person's daily life, with scores ranging from 0-52, with 52 representing greatest severity. The UPDRS subscale III assesses how PD affects how a person moves about, with scores ranging from 0-108, with 108 representing greatest severity. The combination of these 2 scores is used in clinical trials and in clinical practice to get a good overall idea of how PD affects a person's life. Combined score ranges from 0-160, with 160 being greatest severity.|Baseline and 8 weeks|Analysis was by intention to treat and all enrolled subjects completed the entire protocol.|||scores on a scale||Standard Deviation|Mean
1459978|NCT00779142|Secondary|Secondary Would be Significant Clinical Improvement (Judged at the Slit Lamp Exam Using a 90D Lens) in Macular Edema at the End of One Month After the Last Intraocular Injection.||1 month||||Participants|||Count of Participants
1459981|NCT00779116|Primary|Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.|"A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject now that you have tasted the two tablets, show us which tablet you like more and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly."|Following the second dose (8-10 minutes after the first dose)|All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).|||Participants|||Number
1459982|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at End of Study Treatment|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|End of Study treatment (Hour 72)|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1459983|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl ITS at Hour 48|Total number of participants who required intravenous administration postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 48|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1459984|NCT00779038|Secondary|Number of Participants With Physician Global Assessment of Method of Pain Control|"The physician global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the Physicians: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1459985|NCT00779038|Secondary|Number of Participants With Nurse Global Assessment of Method of Pain Control|"The nurse global assessment was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the nurses: Overall, would you rate this method of pain control as being poor, fair, good, or excellent?"|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1459986|NCT00779038|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The PGA was based on categorical evaluation (poor, fair, good or excellent) for the method of pain control by asking following question from the participants: “Overall, would you rate this method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early withdrawal|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1459987|NCT00779038|Primary|Number of Participants With Intravenous Administration During Treatment With Fentanyl Iontophoretic Transdermal System (ITS) at Hour 24|Total number of participants who required intravenous administration (when medicine is given directly into a vein) postoperatively, for treating study treatment related side effect or for additional pain control, during treatment with fentanyl ITS was assessed.|Hour 24|Data was not analyzed because there were insufficient participants to perform a meaningful efficacy analysis due to premature study termination.||||||
1459988|NCT00779025|Secondary|Number of Sensations Experienced by Female Subjects - Overall|Number of sensations experienced by female subjects, based on two applications of the product for each subject.|1 Week|Intention to Treat|||Sensations|Participants||Number
1459989|NCT00779025|Secondary|Number of Sensations Experienced by Male Subjects - Overall|Number of sensations experienced by male subjects, based on two applications of the investigational product.|1 Week||||Sensations|Participants||Number
1459990|NCT00779025|Primary|Number of Participants Showing Change From Baseline in Irritation Scores|Number of participants showing change in irritation scores based on physical examinations of both male and female subjects according to a 6-point scale, ranging from 0=Normal appearance, no irritation to 6 = Presence of Lesions|1 week|Analysis was per Intention to Treat (ITT)|||Participants|||Number
1459991|NCT00778999|Secondary|Number of Good Quality Embryos|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1459992|NCT00778999|Secondary|Number of Fertilized (2PN) Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1459993|NCT00778999|Secondary|Number of Follicles on Day of hCG|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1459994|NCT00778999|Secondary|Number of Follicles on Stimulation Day 8|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1459995|NCT00778999|Secondary|Number of Mature Oocytes|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|12 weeks|||||||
1459996|NCT00778999|Primary|Total Number of Oocytes|The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response|12 weeks|Intent-to-treat, defined as all randomized subjects who received recombinant follicle stimulating hormone|||Number of oocytes||Standard Deviation|Mean
1459997|NCT00778921|Secondary|Biomarker Assessment at Visit 2 (Single Blind Run in), Visit 5 (Randomization), and Visit 9 (EOS)||12 weeks|||||||
1459998|NCT00778921|Secondary|Number of Patients With Any Adverse Event and/or Serious Adverse Event in the Double-blind Period by Treatment Group||8 weeks|Analysis: Intention to Treat (ITT) Imputation Technique: Last Observation Carried Forward (LOCF)|||Participants|||Number
1459999|NCT00778921|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study||Baseline and Week 8|full analysis set|||mm Hg||Standard Error|Least Squares Mean
1460000|NCT00778921|Primary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study||Baseline and Week 8|full analysis set|||mm Hg||Standard Error|Least Squares Mean
1460036|NCT00778648|Secondary|Secondary Endpoints of This Study Are Mean Health-related Quality of Life, Mean Common Cold Related Total Costs, Direct and Indirect (Productivity Loss) Costs||Baseline, months 2,4,6,8.|||||||
1460037|NCT00778648|Primary|Number of Days With at Least Moderate (i.e. Moderate or Severe) Common Cold Symptoms.||within 6 months (after 2 months run-in period)||||Number of days||95% Confidence Interval|Mean
1460001|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460002|NCT00778895|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460003|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460004|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day post-vaccination period after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460005|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|"Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460006|NCT00778895|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|"Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1460007|NCT00778895|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).~This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol."|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1460008|NCT00778895|Secondary|Seroconversion Factor for HI Antibodies|"The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||fold increase||95% Confidence Interval|Geometric Mean
1460038|NCT00778622|Other Pre-specified|Number of Participants Who Had a Normal Electrocardiogram (ECG) at Baseline and an ECG at Week 16 (or Termination Visit) Which Was Considered to be Abnormal With Clinical Significance - Safety Population|Baseline was defined as ECG obtained at the screening visit. A judgment of clinical significance was at the discretion of the investigator. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|number of participants with a normal ECG at baseline for normal weight, overweight, and obese arms were 71, 62, 65, respectively.|||participants|||Number
1460009|NCT00778895|Secondary|Number of Subjects Seroprotected Against HI Antibodies|"A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.~The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida."|At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1460010|NCT00778895|Secondary|Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.|At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1460011|NCT00778895|Secondary|Titers for Serum Hemagglutination Inhibition (HI) Antibodies|Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.|At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1460012|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460013|NCT00778895|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination|"SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460014|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 6-month safety follow up after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460015|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination|"MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.~Analysis of intensity and relationship to vaccination of MAEs was not performed.~This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol."|During the 28-day post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460016|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination|Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 28-day follow-up period (Days 0-27) after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1460039|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week 16 in Diastolic and Systolic Blood Pressure - Safety Population|Baseline was defined as the value obtained at screening or value obtained on Day 1 before treatment. Diastolic and systolic blood pressure was measured in millimeters of mercury (mm Hg). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16||||mm Hg||Standard Deviation|Mean
1463208|NCT00756275|Secondary|Percent Smoking Days||3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of days||Standard Deviation|Mean
1460017|NCT00778895|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination|Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1460018|NCT00778895|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.|During the 4-day follow-up period (Days 0-3) after any vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1460019|NCT00778869|Primary|Number of Genes Which Were Differentially Expressed|Differentially expressed genes were described as those which were at least 1.5 times up- or down-regulated and statistically different at a significance level of 0.05 using a paired t-test comparing 10 ankylosing spondylitis (AS) participants during tumor necrosis factor (TNF) alpha treatment (Remicade) with 10 matched controls. Control samples were previously obtained and not specifically collected for this study.|14 weeks||||Number of genes|||Number
1460020|NCT00778830|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation and TEAEs Leading to Death|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|Safety population consisted of all the enrolled subjects who received at least one dose of study treatment.|||Subjects|||Number
1460021|NCT00778830|Secondary|Overall Survival (OS) Time|OS time was defined as the time from first administration of study drug until date of death, assessed up to 5 years. OS time was censored if the subject was found to be alive on the last date of the assessment.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1460022|NCT00778830|Secondary|Progression-Free Survival (PFS) Time|PFS time was defined as the time from first administration of study drug until first observation of disease progression or death when death occurs within 90 days of the last tumor assessment or first study drug dose whichever occurred.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited and until data cut-off date (31 March 2014)|The ITT population consisted of all the enrolled subjects who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
1460023|NCT00778830|Primary|Percentage of Subjects With Best Overall Confirmed Response Rate (BORR)|Response rate was defined as the percentage of subjects with BORR (confirmed complete response [CR] or partial response [PR]) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. As per RECIST v 1.0 criteria for target lesions and assessed by magnetic resonance imaging (MRI): CR = disappearance of all target lesions; PR = at least 30 percent (%) decrease in the sum of the longest diameter of target lesions. Response rate will be assessed every 8 weeks.|From the start of the trial until disease progression, death or last tumor assessment, reported between day of first subject recruited until data cut-off date (31 May 2012)|Intention-to-treat (ITT) population consisted of all the enrolled subjects who received at least one dose of study treatment.|||Percentage of subjects|||Number
1460024|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks|Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount).|48 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1460025|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks|Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount).|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1460026|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks|Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount).|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1460027|NCT00778817|Secondary|Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks|Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount).|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||participants|||Number
1460114|NCT00777790|Primary|Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.|Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.|Day 0 and 8 and 28 days post-vaccination|GMT results were on the per-protocol population for immunogenicity.|||Titer||95% Confidence Interval|Geometric Mean
1460028|NCT00778817|Secondary|Response at 48 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|48 weeks||||percentage of participants|||Number
1460029|NCT00778817|Secondary|Response at 18 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|18 weeks||||percentage of participants|||Number
1460030|NCT00778817|Secondary|Response at 12 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|12 weeks||||percentage of participants|||Number
1460031|NCT00778817|Secondary|Response at 6 Weeks|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|6 weeks||||percentage of participants|||Number
1460032|NCT00778817|Secondary|Best Response Rates|"RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'.~Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome."|Up to 6 months||||percentage of participants|||Number
1460033|NCT00778817|Primary|Progression-free Survival Rate at 18 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
1460034|NCT00778817|Primary|Progression-free Survival Rate at 12 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|12 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
1460035|NCT00778817|Primary|Progression-free Survival Rate at 6 Weeks|Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 weeks|The analysis population excludes two patients who withdrew from the study before the 6 week assessment.|||percentage of participants|||Number
1472741|NCT00686842|Primary|Safety and Toxicity of Anti-VEGF Small Molecule PTC299|Patients who experienced an adverse event of grade 3 or greater|All study visits||||participants|||Number
1460040|NCT00778622|Other Pre-specified|Mean Change From Baseline at Week at Week 16 in ECG Parameter Heart Rate (HR) - Safety Population|Baseline was defined as ECG obtained at the screening visit. ECG was 12-lead. Heart rate (HR) was measured in beats per minute (beats/min). Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Safety population included 125, 122, 124 participants in each arm, respectively. Participants missing from analysis for change at Week 16 for Heart Rate were 17, 18, 20 participants in the normal, overweight, obese arms, respectively.|||beats/min||Standard Deviation|Mean
1460041|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in Urinalysis - Safety Population|Urinalysis included pH and specific gravity. Baseline defined as values obtained at screening visit. Clinically significant: outside the reference range (low/high)and judged to be significant by the investigator: Specific gravity 1.003 - 1.035; ph 5 - 8. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16||||participants|||Number
1460042|NCT00778622|Other Pre-specified|Number of Participants Who Had Abnormal Increase From Baseline at Week 16 in Kidney or Liver Function Serum Chemistry Values - Safety Population|Baseline defined as value obtained either in screening visit or last value obtained before glucophage XR treatment given on Day 1. Serum chemistries evaluating kidney or liver function: blood urea nitrogen(BUN), serum creatinine (SCr), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin (BR), uric acid (UA). Abnormal increase in kidney and liver function tests defined as 1.25 - less than, equal to (<=)2.6 times (x) upper limit of normal (ULN)in ALT, AST, total BR, UA; abnormal increase defined as 1.25 to <= 5.1 x ULN in BUN. Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|Baseline to Week 16|Number of participants (normal, overweight, obese, respectively) who were missing values and were not included in the Week 16 analysis for the following serum chemistry tests: ALT = 14, 11, 13; AST = 14, 11, 13; total BR = 14, 11, 13; creatinine = 14, 12, 13; BUN = 14, 12, 13; UA = 14, 12, 13.|||participants|||Number
1460043|NCT00778622|Other Pre-specified|Number of Participants With Clinically Significant Changes From Baseline at Week 16 in the Hematology Laboratory Test Profile - Safety Population|Hematology profile = hematocrit, hemoglobin, red blood cell count (RBC), white blood cell count(WBC), lymphocytes, monocytes, basophils, eosinophils, neutrophils, platelet count. Baseline: value obtained at screening or last value obtained before treatment. LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Hemoglobin (g/dL): >3 g/dL decrease from preRX; hematocrit (%): <0.75*preRX; RBC (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/uL): <0.67*LLN or >1.5*ULN, of if preRX<LLN, use 0.5*preRX and <100,000/mm^3; WBC (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; neutrophils+bands (*10^3 c/uL): if value <1.0*10^3 c/uL; eosinophils (*10^3 c/uL): if value >0.750*10^3 c/uL; basophils (*10^3 c/uL): if value >400/mm^3; monocytes (*10^3 c/uL): if value >2000/mm^3; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL.|Baseline to Week 16|Safety population included participants who enrolled in the study and took at least 1 dose of Glucophage XR.|||participants|||Number
1460044|NCT00778622|Other Pre-specified|Number of Participants With Episodes of Lactic Acidosis or Hypoglycemia From Day 1 to Week 16 - Safety Population|Day 1 was first day of treatment. Lactic acidosis defined as elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and increased lactate/pyruvate ratio. Hypoglycemia (low levels of blood glucose) was reported as an adverse event. Safety population included participants who had enrolled in the study and took at least 1 dose of glucophage extended release (glucophage XR). If a subject experienced more than one adverse event, the subject was counted once at the highest severity.|Day 1 to Week 16|All participants enrolled in the study and who received at least 1 dose of Glucophage XR.|||participants|||Number
1460045|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 78, 70, and 72 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mg/L||95% Confidence Interval|Mean
1460046|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL.|Baseline to Week 16|Full Analysis Set (FAS) population = 111, 111, 112 in normal, overweight, obese participants respectively. For this outcome measure, 84, 79, and 75 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||U/mL||95% Confidence Interval|Mean
1460047|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 102, 95, and 85 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mg/L||95% Confidence Interval|Mean
1460048|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 4, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1460311|NCT00775528|Secondary|Fat Intake (g)|The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Grams||Standard Deviation|Mean
1460049|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set|Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 2, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1460050|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set|Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 9 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1460051|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set|For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) consisted of participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 3, and 8 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1460052|NCT00778622|Secondary|Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set|Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.|Baseline to Week 16|Full Analysis Set (FAS) included enrolled participants,who took at least 1 dose of drug and had at least 1 post baseline HbA1c assessment. For this outcome measure, 1, 1, and 1 normal, overweight, obese participants, respectively, were missing and were not included in the analysis.|||mmol/L||95% Confidence Interval|Mean
1460053|NCT00778622|Primary|Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)|Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.|Baseline to Week 16|Full Analysis Set included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. Baseline data was not carried forward or averaged with on-treatment data to impute missing values for the LOCF data set.|||percentage of hemoglobin||95% Confidence Interval|Mean
1460054|NCT00778375|Secondary|Overall Response Rate (CR, CRp/CRi and PR)|IWG Response criteria (2003): Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 10^9/L or Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial Remission (PR): Blood count recovery as for CR, but with both a decrease in marrow blasts of at least 50% and not more than 6 to 25% abnormal cells in the marrow. Participants not achieving a complete remission following first induction course, can receive a second induction course at least 28 days following first to optimize response if possible.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|Of 119 enrolled, one participant was not evaluable for response.|||Percentage of Participants|||Number
1460055|NCT00778375|Secondary|Event Free Survival (EFS)|EFS is defined as length of time after primary treatment for a cancer ends that the participant remains free of certain complications or events that the treatment was intended to prevent or delay, for example but not exclusive of hematologic and non-hematologic toxicities, cumulative toxicities with consolidation courses, or emergence of resistance to the chemotherapy component of treatment.|Follow up up to 5 years/60 months.|Of 119 enrolled, one participant was not evaluable for response.|||Months||Full Range|Median
1460056|NCT00778375|Primary|Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days|One participant of 119 treated was not evaluable for response. Twenty-two participants required re-induction.|||Participants|||Number
1460057|NCT00778375|Primary|Median Overall Survival (OS)|Overall survival (OS): Time from date of treatment start until date of death due to any cause.|Evaluated from treatment date until date of death, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.|||Months||Full Range|Median
1460058|NCT00778375|Primary|Complete Remission (CR) Rate for First 60 Participants|All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 times 10^9/L and platelet count > 100 times 10^9/L, and normal bone marrow differential (< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.|Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days|The outcome population consisted of first sixty participants enrolled between October 2008 and January 2010, of whom 59 were evaluable for response.|||Percentage of Participants|||Number
1460059|NCT00778375|Primary|Disease-free (DFS) or Relapse-free Survival (RFS) Time|Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.|Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.|One participant of 119 treated was not evaluable for outcome.|||Months||Full Range|Median
1460060|NCT00778336|Secondary|Description of Treatments by Thrombotic Condition|The # of patients that were exposed to each treatment at least once in the given thrombotic condition.|Index Procedure||||Participants|||Number
1460061|NCT00778336|Secondary|Rethrombosis|The number of patients that had rethrombosed in the vessels treated during the index procedure (initial endovascular procedure).|3 Month Follow Up||||Participants|||Number
1460062|NCT00778336|Primary|Change From Baseline to Final Angiographic Results|"From the Index Procedure's Baseline (pre-endovascular treatment) and Final (post-endovascular treatment) angiograms,each vessel was assigned a value by the treating physician:~complete occlusion (> 90% occlusion);~substantial occlusion (50-90% occlusion OR <50% occlusion and >3cm in length);~partial occlusion (<50% occlusion AND <3cm in length);~patent (Without visable thrombus or occlusion).~The levels of change (improvement) were calculated by subtracting the baseline assigned angiographic value from the final value."|Index Procedure ( pre-endovascular treatment and post-endovascular treatment)|Intention to Treat (ITT)|||Occlusion Index||Standard Error|Mean
1460063|NCT00778310|Primary|Brain Oxygenation Level Dependent Signal in the Fusiform Gyrus and the Amygdala on Concerta vs. Placebo|Each subject viewed shapes and faces on multiple trials. The subject matched faces or shapes on each trial. BOLD activity during shape trials was subtracted from BOLD activity during Face trials and this value was compared on drug vs. placebo trials.|Placebo and Drug day, 1-2 weeks apart|The number who completed both fMRI one week apart (crossover study, scanned twice|||Face-Shape BOLD signal difference||Standard Deviation|Mean
1460064|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline to the time complete milk tolerance was established|Data were not collected and therefore no analyses could be performed.||||||
1460065|NCT00778258|Secondary|Changes in Mechanistic Values [Humoral, T Cell and Basophil]|This outcome measure was not well defined in the protocol and was not analyzed.|Baseline, Month 12, Month 24, and Month 36|Data were not collected and therefore no analyses could be performed.||||||
1460066|NCT00778258|Secondary|Comparison of Percent of Participants Tolerant to Non-heated Milk Between the Participants Who Ingested Baked-milk Products and Participants Who Continued to Avoid All Forms of Milk|Participants were grouped based on the food they reacted to, at the baseline Oral Food Challenge (OFC). Group 1= reacted to muffin; Group 2= reacted to pizza; Group 3= reacted to rice pudding; Group 4= reacted to non-baked milk; Group 5= did not react. Groups 2- 4 were randomized to dose escalation or maintenance, and Group 1, and a Control group that chose not to participate in the study, continued to avoid milk. Randomized participants performed an OFC at each visit during which they were given progressively less denatured/ baked milk protein food items until they had an allergic reaction. Participants were considered tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk. Tolerance of non-heated milk was assessed by report among those who continued to avoid milk.|Month 36|Randomized and comparison participants|||percent participants|||Number
1460067|NCT00778258|Secondary|Relationship Between Dose of Baked-milk Protein and Reactivity to Casein Versus Whey|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. The relationship between serum IgE to betalactoglobulin and casein, and the food level at which the participant reacted, were evaluated at each post randomization OFC visit. It is expected that those who reacted to muffin would have a higher ratio of casein to betalactoglobulin than those who reacted to less heated forms of milk.|Baseline, Month 12, Month 24, Month 36|Intent-to-treat|||Ratio||Inter-Quartile Range|Median
1460068|NCT00778258|Secondary|Relationship Between Initial Dose of Tolerated Baked-milk Protein and Time to Complete Tolerance|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any food, including unheated whole milk.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat participants who achieved tolerance|||months||Standard Deviation|Mean
1460069|NCT00778258|Secondary|Comparison of Baseline Mechanistic Studies [Treg and Basophil] With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of the number of basophils and T regulatory cells reactive to milk proteins and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat|||cells/µL||Inter-Quartile Range|Median
1460070|NCT00778258|Secondary|Comparison of Baseline IgE With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarker of IgE to milk proteins and allergic reaction at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Quantitative IgE to milk proteins was done using FEIA (UniCAP) on serum from blood drawn at baseline.|Baseline|Intent-to-treat|||kUa/L||Inter-Quartile Range|Median
1460071|NCT00778258|Secondary|Comparison of Baseline Basophil Percent Maximal Degranulation With the Outcome of the Baseline OFC to Identify the Biomarkers of Clinical Reactivity|This endpoint evaluates the correlation between the mechanistic biomarkers of basophil reactivity and the food to which participants reacted at baseline. Participants were grouped according to food at which participants experienced a reaction during their baseline oral food challenge: Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Basophils come from blood drawn at baseline. Basophils counts were done using whole blood specimens. Basophil reactivity as measured as maximal degranulation percentage after stimulation with titrated dilutions of milk powder (from 1x103 to 1x10-1 µg/mL total protein) and was correlated to group assignment using Spearman correlation coefficients.|Baseline|Intent-to-treat|||percentage of max basophil degranulation||Inter-Quartile Range|Median
1460072|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at any post-randomization visit up through 36 months, they did not react to any of the food given in the OFC.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat|||percentage of participants|||Number
1460073|NCT00778258|Secondary|Percent of Participants Becoming Tolerant to Unheated Cow's Milk at 12, 24, and 36 Months|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to become tolerant to unheated cow's milk if at the specified visit, they did not react to any of the foods given in the OFC.|12 months, 24 months, and 36 months|Randomized intent-to-treat|||percentage of participants|||Number
1460074|NCT00778258|Secondary|Number of Participants With a Positive Progression in Tolerating More Allergenic Forms of Milk at 12 and 24 Months|Participants were grouped based on the food they experienced a reaction to at the baseline Oral Food Challenge (OFC). Group 1 = reacted to muffin; Group 2 = reacted to pizza; Group 3 = reacted to rice pudding; Group 4 = reacted to non-baked milk; Group 5 = did not react. Groups 2, 3 and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, performed an OFC where food products containing milk protein denatured through baking were given. Participants were given progressively less denatured milk protein food items until an allergic reaction occurred. A positive progression in tolerance of baked milk was defined as a reaction to a less denatured milk protein food at 12 months than at baseline. Positive progression at 24 months was defined as experiencing a reaction to a less denatured milk protein food at 24 months than at 12 months.|12 months, 24 months|Randomized intent-to-treat|||participants|||Number
1460075|NCT00778258|Primary|Number of Participants With a Positive Progression in Tolerance of Baked Milk and Ultimately Unheated Milk in Dose Escalation Sub-arm Compared to Maintenance Sub-arm|Participants were grouped based on the food to which they experienced a reaction at the baseline Oral Food Challenge (OFC). Group 1=reacted to muffin; Group 2=reacted to pizza; Group 3=reacted to rice pudding; Group 4=reacted to non-baked milk; Group 5=did not react. Groups 2, 3, and 4 were randomized to dose escalation or maintenance, and at each visit following randomization, participants performed an OFC where they were given food products containing milk protein denatured through baking. Participants were given progressively less denatured milk protein food items until they had an allergic reaction. Participants were considered to have a positive progression in tolerance of baked milk if they experienced a reaction to a less denatured milk protein food item at any post randomization visits than the one to which they reacted at their baseline visit.|Randomization through end of study (up to 36 months)|Randomized intent-to-treat|||participants|||Number
1460076|NCT00778167|Primary|Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One)|Patients were evaluable for cohort dose escalation/de-escalation decision making either if they experienced DLTs in cycle 1 or if they had completed 24 of the planned 28 days (85%) dosing of erlotinib and three of the four planned days of weekly dosing of cixutumumab (75%) in cycle 1 in cohorts 1 and 2 in the absence of DLTs. In cohort 3, patients were evaluable for tolerability if they had completed 18 days (85%) dosing of erlotinib and had received the planned day 1 dose of cixutumumab.|From time of first dose up to 28 days|Patients were evaluated with history, physical examination, vital signs, and blood tests weekly through cycle 1 and on day 1 of each subsequent cycle. Incidence and severity of AEs were collected at each study visit and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.|||Participants|||Number
1460139|NCT00777205|Primary|Depression Symptoms|The 21-item Beck Depression Inventory-2nd Edition (BDI-II) was used to assess depressive symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1460077|NCT00778102|Secondary|Percentage of Participants With Complications Related to Second Resective Surgery|Complications related to the second resective surgery were evaluated using the NCI-CTCAE version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 = resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given AE by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent second resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (Second Surgery Subpopulation): All participants who underwent a second resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.|||percentage of participants|||Number
1460078|NCT00778102|Secondary|Percentage of Participants With Complications Related to First Resective Surgery|Complications related to the first resective surgery were evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0, and classified according to severity. The NCI-CTCAE severity classification criteria are as follows: Grade 5 equals (=) resulting in death; Grade 4 = life-threatening; Grade 3 = severe; Grade 2 = moderate; and Grade 1 = mild. The percentage of participants experiencing a given adverse event (AE) by severity grade was calculated as [number of participants with an AE divided by the number of participants who underwent first resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|Safety Population (First Surgery Subpopulation): All participants who underwent a first resective surgery and who received at least one dose of trial medication, whether prematurely withdrawn or not. Participants were analyzed according to the actual treatment they received.|||percentage of participants|||Number
1460079|NCT00778102|Secondary|Time to Response|Time to response according to RECIST version 1.0 was defined as the time from randomization to the date of first documented CR or PR. Participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. For participants who did not complete a confirmatory tumor assessment, time to response was censored at the date of last tumor assessment, or if unavailable, at the date of first dose. Time to response was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||months||95% Confidence Interval|Median
1460080|NCT00778102|Secondary|Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0|Using RECIST version 1.0, participants were considered to have achieved CR upon the disappearance of all target and non-target lesions. Participants who achieved PR demonstrated at least a 30% decrease in the sum of the largest diameter of target lesions, taking as reference the Screening sum largest diameter. Responses were confirmed by repeat assessments no less than 4 weeks after criteria for response were first met. The collective percentage of participants with confirmed best overall response of CR or PR was calculated as [number of participants meeting RECIST criteria for CR or PR divided by the number of participants analyzed] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1460081|NCT00778102|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause. For participants without an event of death, OS was censored at the last-known alive date. OS was estimated by Kaplan-Meier analysis.|Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population|||months||95% Confidence Interval|Median
1460082|NCT00778102|Secondary|Percentage of Participants Who Died||Up to 5 years (prior to each cycle, and within 7 days prior to surgery; at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population|||percentage of participants|||Number
1460083|NCT00778102|Secondary|Progression-Free Survival (PFS)|PFS was defined, using RECIST version 1.0, as the time from randomization to the date of first documented PD or death from any cause. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. For participants without documented PD or death, PFS was censored at the time of last tumor assessment. PFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||months||95% Confidence Interval|Median
1460084|NCT00778102|Secondary|Percentage of Participants Experiencing Death or Disease Progression|PD was defined, using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. The percentage of participants experiencing PD or death was calculated as [number of participants with event divided by the number of participants analyzed] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; 4 and 12 weeks after surgery; and at the end of Cycles 4 and 8 if assessed as R0 or R1, or every 6 weeks until progression or resectability if assessed as R2)|ITT Population|||percentage of participants|||Number
1460176|NCT00777036|Secondary|Time to Complete Cytogenetic Response (CCyR)|Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR.|From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)|All treated participants with CCyR|||months||95% Confidence Interval|Median
1460085|NCT00778102|Secondary|Relapse-Free Survival (RFS)|RFS was defined as the time from curative resection (complete resection [R0] or microscopic residual tumor [R1]) to the date of first diagnosis of relapse. For participants with curative resection and without relapse, RFS was censored at the last known relapse-free assessment. RFS was estimated by Kaplan-Meier analysis.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.|||months||95% Confidence Interval|Median
1460086|NCT00778102|Secondary|Percentage of Participants Experiencing Relapse Following Curative Resection|Among participants with curative resection (complete resection [R0] or microscopic residual tumor [R1]), relapse was defined as the first new occurrence of cancer or death. The percentage of participants who experienced relapse was calculated as [number of participants with a relapse event divided by the number of participants initially classified as R0 or R1 following resective surgery] multiplied by 100.|Up to 5 years (at time of surgery; 48 hours and 4 and 12 weeks after surgery; within 4 weeks after completion of treatment; every 3 to 6 months for 1 year; then annually)|ITT Population; only participants with a residual tumor classification of R0 or R1 after first resection were included in the analysis.|||percentage of participants|||Number
1460087|NCT00778102|Secondary|Percentage of Participants With Complete or Major Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as [number of participants with complete or major response divided by the number of participants who completed the assessment] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1460088|NCT00778102|Secondary|Percentage of Participants With Histopathological Response|At the time of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response could not be determined in some cases and was documented as 'Unknown.' The percentage of participants within each response category was calculated as [number of participants with a given response divided by the number of participants who completed the assessment] multiplied by 100.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population; only participants with a histopathological assessment after the first resective surgery were included in the analysis.|||percentage of participants|||Number
1460089|NCT00778102|Secondary|Time to Resection|Time to resection was defined as the time from randomization to the date of first resective surgery. For participants who did not undergo resective surgery, time to resection was censored at Day 1. Time to resection was estimated by Kaplan-Meier analysis.|Up to 5 years (at Screening; prior to each cycle, and within 7 days prior to surgery; and at time of surgery)|ITT Population|||months||95% Confidence Interval|Median
1460090|NCT00778102|Primary|Percentage of Participants With Complete Resection or Residual (Microscopic or Macroscopic) Tumor|Following resective surgery, participants were evaluated for complete resection (R0) or the presence of microscopic (R1) or macroscopic (R2) residual tumor. The percentage of participants within each residual tumor classification was calculated as [number of participants with R0, R1, and/or R2 divided by the total number of participants] multiplied by 100. Associated 95% confidence intervals were calculated for one-sample binomial using the Clopper-Pearson method.|Up to 5 years (at Screening; every 6 weeks, and within 4 weeks prior to surgery; and at time of/after surgery)|ITT Population|||percentage of participants||95% Confidence Interval|Number
1460091|NCT00777946|Secondary|Percentage of Participants Achieving a Systolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Systolic Blood Pressure Response was defined as a mean sitting Systolic Blood Pressure (msSBP) <140 mmHg or a ≥ 20 mmHg reduction in msSBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
1460092|NCT00777946|Secondary|Percentage of Participants Achieving a Diastolic Blood Pressure Response|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~A Diastolic Blood Pressure Response was defined as a mean sitting Diastolic Blood Pressure (msDBP) <90 mmHg or a ≥ 10 mmHg reduction in msDBP from baseline."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
1460256|NCT00776555|Secondary|DRQ-S, Question 1|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
1460093|NCT00777946|Secondary|Percentage of Participants Achieving Blood Pressure Control|"After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.~Blood Pressure control was defined as having a mean sitting Diastolic Blood Pressure <90 and a mean sitting Systolic Blood Pressure <140."|8 weeks|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||Percentage of participants|||Number
1460094|NCT00777946|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|"The number of participants with any Serious Adverse Event and the number of participants with Adverse Events in any system organ class.~Additional information about Adverse Events can be found in the Adverse Event Section."|8 weeks|Safety Population consisted of all randomized participants who received study drug.|||participants|||Number
1460095|NCT00777946|Secondary|Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msSBP at baseline from the msSBP at 8 weeks was calculated using an ANCOVA model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||mm Hg||Standard Error|Least Squares Mean
1460096|NCT00777946|Primary|Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)|After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.|Baseline, End of Study (Week 8)|Full Analysis Set (all randomized patients who received study drug). Three patients (1 in Aliskiren 300 mg/Amlodipine 10 mg group and 2 in the Aliskiren 300 mg/Amlodipine 5 mg group were excluded from the analysis due to lack of post-baseline assessment.|||mm Hg||Standard Error|Least Squares Mean
1460097|NCT00777855|Secondary|Maximum Plasma Concentration (Cmax) of S-warfarin and R-warfarin|Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days|||ng/ml||Standard Deviation|Mean
1460098|NCT00777855|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity of S-warfarin and R-warfarin|Analysis of all concentration-time data. Blood collection 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after warfarin dosing.|0-120 hours after warfarin dosing|Each of 10 participants received both treatments, in randomly assigned order, separated by a minimum of 14 days|||ng/ml*h||Standard Deviation|Mean
1460099|NCT00777855|Primary|S- and R- Enantiomers of Warfarin (S-warfarin and R-warfarin) Area Under the Plasma Concentration-time Curve (AUC) From 0 to 12 Hours.|Uptake effects on warfarin pharmacokinetics during time period of hepatic organic anion-transporting polypeptide (OATP) inhibition by rifampin. Blood collection 1, 2, 4, 6, 8, and 12 hours after warfarin dosing.|0-12 hours after warfarin dosing|Each of 10 participants received both treatments separated by a minimum of 14 days; treatment sequence was randomly assigned|||ng/ml*h||Standard Deviation|Mean
1460100|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.|||participants|||Number
1460101|NCT00777803|Secondary|Responder by Patient's Global Assessment at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing scores were not imputed.|||participants|||Number
1460102|NCT00777803|Secondary|Response by Patient's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460103|NCT00777803|Secondary|Responder by Patient's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1463209|NCT00756275|Primary|7-day Point-prevalence Smoking Abstinence|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|6 month follow up||||participants|||Number
1460104|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460105|NCT00777803|Secondary|Responder by Patient’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460106|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460107|NCT00777803|Secondary|Responder by Investigator’s Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460108|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460109|NCT00777803|Secondary|Responder by Investigator’s Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460110|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460111|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Rest at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460112|NCT00777803|Secondary|Responder by Independent Rater's Assessment at Maximum Frown at Week 12|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|12 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1460113|NCT00777803|Primary|Responder by Independent Rater's Assessment at Maximum Frown at Week 4|The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.|4 weeks after injection|Analysis per protocol: All subjects who received study medication, for whom a facial wrinkle score at maximum frown was observed at baseline and who had no major protocol deviations. Missing facial wrinkle scores were not imputed.|||participants|||Number
1461385|NCT00768989|Secondary|Raltegravir Cmax in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
1460115|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Patients With Allergic Asthma)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:100,000 dilutions: n=30; for 1:10,000 dilutions: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
1460116|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Intradermal Test in Healthy Volunteers)|For intradermal testing, positive control (histamine 0.1 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The intradermal test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population. For 1:1000 dilutions: n=27; for 1:100 dilutions: n=21; for 1:10 dilutions: n=13. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
1460117|NCT00777764|Primary|Number of Participants Who Experienced a Positive Skin Reaction (Skin Prick Test)|For skin prick, positive control (histamine 6 mg/mL) and negative control (saline) were used. Positive skin reaction was defined as a ≥ 3-mm wheal and/or > 10-mm erythema from negative control. The skin prick test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped.|on the day of skin test|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient. For healthy volunteer cohort, undiluted: n=29. The skin tests started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped (i.e., reason for different Ns per dilution.)|||participants|||Number
1460118|NCT00777764|Primary|Number of Participants by of Adverse Events Following a Skin Test Procedure|"Skin test procedures were skin prick test or intradermal test. The test started with the lowest concentration. If a positive skin reaction was observed, escalation to the next dilution was stopped. Subjects were observed for 20 minutes following each test; subjects were observed for 1 hour after the last intradermal test. Those with a positive response were observed for an additional 6 hours.~Severity refers to the intensity of an AE (mild, moderate or severe). Mild is itching or hives, for example. A severe event requires emergency medical treatment and can result in death."|Up to 7 days following skin testing|Safety population, defined as subjects who received at least one concentration of omalizumab or omalizumab excipient.|||participants|||Number
1460119|NCT00777634|Primary|Incidence of Diagnosis of Three or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of three or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
1460120|NCT00777634|Primary|Incidence of Diagnosis of Two or More Metabolic Syndrome Components|The number of participants to acquire a new diagnosis of two or more components of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
1460121|NCT00777634|Primary|Incidence of Diagnosis of Any Metabolic Syndrome Component|The number of participants to acquire a new diagnosis of one component of metabolic syndrome. Metabolic syndrome can include abdominal obesity, high blood pressure, high cholesterol, etc.|Baseline to 5 years||||participants|||Number
1460122|NCT00777634|Primary|Incidence of Diagnosis of Type 2 Diabetes|The number of participants to acquire a new diagnosis of Type 2 Diabetes over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
1460123|NCT00777634|Primary|Incidence of Diagnosis of Hypertension|The number of participants to acquire a new diagnosis of high blood pressure(hypertension) over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
1460124|NCT00777634|Primary|Incidence of Diagnosis of Dyslipidemia|The number of participants to acquire a new diagnosis of high cholesterol (dyslipidemia) over the course of the baseline to five-year followup.|Baseline to 5 years||||participants|||Number
1460125|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12|"The ADAS-Cog is a psychometric instrument that evaluates memory, attention,~reasoning, language, orientation and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment. A reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the ADAS-Cog score at Weeks 4, 8 and 12 compared to baseline."|Baseline and 4 weeks, 8 weeks and 12 weeks.|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
1460126|NCT00777608|Secondary|Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change from baseline in the CogState Composite Score at Weeks 4, 8 and 12.|Baseline and 2 weeks, 8 weeks and 12 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
1460358|NCT00775437|Secondary|Creatinine: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
1460127|NCT00777608|Primary|Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4|CogState is a simple, brief computerized neuropsychological battery to evaluate cognitive impairments characterizing mild-to-moderate Alzheimer’s Disease (AD). The composite CogState assesses attention and memory functions - including Verbal episodic memory, Visual Episodic Memory, Psychomotor function, Visual attention and working memory. CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions. Reported here is the change in the CogState Composite Score at Week 4 compared to baseline.|Baseline and 4 weeks|The analysis for the primary and secondary CogState endpoints was done on a per protocol basis (only participants who were compliant and successfully tolerated the forced titration after 2 weeks of treatment were included in the analysis).|||Score on a scale||Standard Error|Least Squares Mean
1460128|NCT00777556|Secondary|Participants Summarized by Repeat Use of Emergency Contraception (EC)|As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.|up to week 8|Participants dispensed the product|||participants|||Number
1460129|NCT00777556|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.|Day 1 to week 8|Safety population of participants who took study drug|||participants|||Number
1460130|NCT00777556|Primary|Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions|The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.|Week 1|Eligible participants who appropriately self-selected and used the product.|||percentage of treated participants||95% Confidence Interval|Number
1460131|NCT00777556|Primary|Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions|The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.|Day 1|Enrolled participants|||percentage of participants||95% Confidence Interval|Number
1460132|NCT00777335|Secondary|Corrected QT Interval Fridericia's Formula (QTcF)|Prolonged QTcF: QTcF >450 msec and increase of baseline on greater than or equal to 60 msec.|Panobinostat intra-venous (i.v.): All cycles pre-dose measurements. For cycles 1 and 2, post-dose measurements as well. / Panobinostat oral: Pre-dose and post-dose measurements for all cycles. Note: each cycle = 3 weeks||||participants|||Number
1460133|NCT00777335|Primary|Overall Response (OR) Rate (as Determined by the Investigator): the Number of Patients Assigned to a Treatment Arm With a Confirmed Best Response of Complete Response(CR) or Partial Response (PR).|"The assessment of OR is based on the response of target lesion, of non-target lesion and on presence of new lesions (RECIST Criteria (V1.0)-assessed by CT scan spiral and bone scan)~CR:Disappearance of all target lesions~PR:>=30% increase in the sum of the longest diameter (SLD),taking as reference the nadir SLD~Progressive Disease (PD):>=20% increase in the SLD, taking as reference the nadir SLD, or the appearance of one or more new lesions~Stable Disease(SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the nadir SLD"|At screening, every 2 cycles (i.e. 6 weeks) during the first 6 cycles, every 3 cycles (i.e. 9 weeks) during the subsequent cycles and at the End of Treatment (EOT) visit. After the EOT, the tumor assessments should be performed every 9 weeks.||||participants|||Number
1460134|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 Post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1460135|NCT00777257|Secondary|Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.|Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.|0 to 7 days post-vaccination|Safety analysis was on all enrolled and vaccinated participants intend-to-treat population|||Percentage of participants|||Number
1460136|NCT00777257|Primary|Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.||Day 0 and Day 28 post-vaccination|Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
1460137|NCT00777257|Primary|Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.||Day 0 to Day 28 post-vaccination|Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population|||Percentage of participants|||Number
1460138|NCT00777205|Primary|Recovery Orientation|The 30-item Mental Health Recovery Measure (MHRM) was used to assess recovery orientation. The MHRM has been fielded among diverse populations and has a high level of internal consistency (Cronbach’s α =.93) and shows change following engagement in recovery oriented treatments. The MHRM is scored using a 5 point Likert Scale (0 to 4) for each item, yielding a theoretical range from 0 – 120 for Total Score. Higher scores correspond to a higher self-reported level of mental health recovery.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1461841|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1460140|NCT00777205|Primary|Quality of Life|The 14-item Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), which has good reliability and has been used in multiple depression studies, was used to assess quality of life. Responses are scored on a 5-point scale (‘not at all or never’ to ‘frequently or all the time’), where higher scores indicate better enjoyment and satisfaction with life (possible range 14–70).|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1460141|NCT00777205|Primary|Change in Functional Status-Physical Health (PCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1460142|NCT00777205|Primary|Change in Functional Status-Mental Health (MCS) Over 12 Month Period|The Veterans Rand 36 Item Health Survey (VR-36) mental health component score (MCS) and physical health component score (PCS) were used as measures of functional status. The MCS and PCS have a mean of 50 and standard deviation of 10, with higher scores indicating better health.|Change over study period|Fifty-six of the patients randomized to the telephone-based peer support intervention were excluded from main study analyses because of an unforeseen disruption in their 6-month intervention that was unrelated to patient characteristics.|||units on a scale||Standard Deviation|Mean
1460143|NCT00777179|Secondary|Objective Response Rate (ORR)|"Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response."|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||Participants|||Number
1460144|NCT00777179|Secondary|Disease of Response (DOR)|"Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response.~Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response"|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||Participants|||Number
1460145|NCT00777179|Secondary|Overall Survival (OS)|Overall survival (OS) defined as the median time from randomization to death from any cause.|Every 12 weeks unless the patient withdraws consent||||months||95% Confidence Interval|Median
1460146|NCT00777179|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.|Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.||||months||95% Confidence Interval|Median
1460147|NCT00777179|Primary|Progression-free Survival (PFS) Rate at 3 Months|Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.|12 weeks|The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.|||Participants|||Number
1460148|NCT00777153|Secondary|Steroid Free Days|Number of days known not to have used any steroids prior to progression|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25||||Days||Standard Deviation|Mean
1460149|NCT00777153|Secondary|Daily Steroid Dose|The mean steroid dosage prior to treatment will be considered as the patient’s baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md – bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.|Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25||||percentage of change|||Number
1460150|NCT00777153|Secondary|Alive and Progression Free Rate at 6 Months (APF6)|Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.|6 Months||||% of patients alive and progression free|||Number
1460151|NCT00777153|Secondary|Response Rate|"An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.~An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan."|Baseline at 6 weeks and then every 6 weeks to discontinuation|Patients are only included in the analysis if they have measurable disease at baseline based on central.|||Participants|||Number
1460152|NCT00777153|Secondary|Overall Survival (OS)|Number of months from randomisation to the date of death from any cause|Baseline through to date of death up to 25th April 2010||||Months||Inter-Quartile Range|Median
1460177|NCT00777036|Secondary|Duration of Major Cytogenetic Response (MCyR)|Duration of MCyR will be computed from the first day criteria are met for MCyR until the date PD is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last.|From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)|All treated participants with MCyR|||months||95% Confidence Interval|Median
1463210|NCT00756275|Secondary|Length of Longest Continuous Abstinence||Weeks 9 to 12||||Days||Standard Deviation|Mean
1460153|NCT00777153|Primary|Progression Free Survival (PFS)|"For patients with measurable disease at entry (at least one lesion that has a shortest diameter~≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:~The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.~The patient has died from any cause.~A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm."|Baseline at 6 weeks and then every 6 weeks to discontinuation||||Days||Inter-Quartile Range|Median
1460154|NCT00777101|Secondary|Time to CNS Metastases|Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).|From randomization date to first CNS symptom or lesions|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
1460155|NCT00777101|Secondary|Frequency of CNS Metastases (Frequency)|The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.|From randomization date to first CNS symptom or lesions|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants|||Number
1460156|NCT00777101|Secondary|Duration of Response|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From start date of response to first PD, assessed up to 69 months after the first subject was randomized.|No. of Subjects with either complete or partial response.|||months||95% Confidence Interval|Median
1460157|NCT00777101|Secondary|Clinical Benefit Rate|"Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.~Clinical Benefit (CB) = CR + PR + SD >= 24 weeks."|From randomization date to progression or last tumor assessment, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants||95% Confidence Interval|Median
1460158|NCT00777101|Secondary|Objective Response Rate (ORR).|Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From randomization date to progression or last tumor assessment, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||percentage of participants||95% Confidence Interval|Number
1460159|NCT00777101|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.|From randomization date to death, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
1460160|NCT00777101|Primary|Progression Free Survival|Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.|From randomization date to progression or death, assessed up to 69 months|Intent to Treat population, includes all subjects who were randomized.|||months||95% Confidence Interval|Median
1460161|NCT00777062|Primary|Time Line Follow Back -Reported Days of Abstinence From Drinking|Percentage of participants who were abstinent from drinking|8 week medication phase||||Percentage of Participants|||Number
1460162|NCT00777062|Primary|Urine Assay for Benzoylecgonine (BE), the Primary Metabolite of Cocaine.|Percentage of subjects with no cocaine use for at least 3 weeks|8 week medication phase||||Percentage of Participants|||Number
1460163|NCT00777049|Primary|Objective Response Rate (as Determined by Investigator): the Percentage of Patients Assigned to a Treatment Arm With a Confirmed Best Response of CR or PR.|The assessment of overall response (OR) is based on the response of target lesion, of non-target lesion, and on presence of new lesions (RECIST criteria version 1.0 using imaging techniques; as per investigator assessment).|6 years and 2 months||||participants|||Number
1460164|NCT00777036|Secondary|Complete Molecular Response (CMR) Rate up to 2 Years|Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.|24 months|All randomized treated participants|||percentage||95% Confidence Interval|Number
1460178|NCT00777036|Secondary|Time to Major Cytogenetic Response (MCyR)|Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR.|From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)|All treated participants with MCyR|||months||95% Confidence Interval|Median
1460179|NCT00777036|Secondary|Rate of Best Cytogenetic Response|The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|All treated participants|||percentage of participants|||Number
1460165|NCT00777036|Secondary|Major Molecular Response (MMR) Rate up to 2 Years|Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant’s individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1460166|NCT00777036|Secondary|Complete Cytogenetic Response (CCyR) Rate up to 2 Years|Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1460167|NCT00777036|Secondary|Major Cytogenetic Response (MCyR) Rate up to 2 Years|Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.|24 months|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1460168|NCT00777036|Secondary|Complete Molecular Response (CMR) Rate|Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.|From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)|All treated participants|||percentage||95% Confidence Interval|Number
1460169|NCT00777036|Secondary|Major Molecular Response (MMR) Rate|Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant’s individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.|From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)|All randomized treated participants|||percentage of participants||95% Confidence Interval|Number
1460170|NCT00777036|Secondary|Overall Survival (OS) Rate at 2 Years|OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.|2 years|All randomized and treated participants|||percentage||95% Confidence Interval|Number
1460171|NCT00777036|Secondary|Disease-Free Survival Rate at 2 Years|Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation.|2 years|All randomized treated participants with response of CCyR or CHR|||percentage||95% Confidence Interval|Number
1460172|NCT00777036|Secondary|Duration of Complete Hematologic Response (CHR)|Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.|From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)|All treated participants with CCyR|||months||95% Confidence Interval|Median
1460173|NCT00777036|Secondary|Time to Complete Hematologic Response (CHR)|Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.|From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)|All treated participants with CHR|||months||95% Confidence Interval|Median
1460174|NCT00777036|Secondary|Progression-Free Survival (PFS) Rate at 2 Years|"PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation.~Disease Progression was defined as any of the following criteria:~For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose~Increasing WBC~Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood)~Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir~Death from any case during treatment"|2 years|All treated participants|||percentage||95% Confidence Interval|Number
1460175|NCT00777036|Secondary|Duration of Complete Cytogenetic Response (CCyR)|Duration of CCyR will be computed from the first day criteria are met for CCyR until the date PD is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last.|From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)|All treated participants who achieved CCyR|||months||95% Confidence Interval|Median
1460180|NCT00777036|Secondary|Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3|Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohorts 1 and 3|||percentage of participants||95% Confidence Interval|Number
1460181|NCT00777036|Secondary|Major Cytogenetic Response (MCyR) Rate in Cohort 2|Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 2|||percent of participants||95% Confidence Interval|Number
1460182|NCT00777036|Primary|Complete Cytogenetic Response (CCyR) Rate|Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 3|||percentage of participants||95% Confidence Interval|Number
1460183|NCT00777036|Primary|Complete Hematologic Response (CHR) Rate|Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 2|||percentage of participants||95% Confidence Interval|Number
1460184|NCT00777036|Primary|Major Cytogenetic Response (MCyR) Rate|Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.|From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)|Cohort 1|||percentage of participants||95% Confidence Interval|Number
1460185|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 12 weeks of treatment|Intent to treat population|||Units on a scale||95% Confidence Interval|Least Squares Mean
1460186|NCT00777023|Primary|Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe."|At baseline and 4 weeks of treatment|Intent to treat population|||Units on a scale||95% Confidence Interval|Least Squares Mean
1460187|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 12 weeks of treatment|Intent to treat population|||Hot flashes||95% Confidence Interval|Least Squares Mean
1460188|NCT00777023|Primary|Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment|Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis|At baseline and 4 weeks of treatment|Intention to treat population|||Hot flashes||95% Confidence Interval|Least Squares Mean
1460189|NCT00776997|Secondary|Average Daily Proton-pump Inhibitor (PPI) Dosage Reduced by at Least 50% Compared to Baseline||12 months||||participants|||Number
1460190|NCT00776997|Secondary|At Least a 50% Reduction in Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) Total Score Compared to Baseline||12 months||||participants|||Number
1460191|NCT00776997|Primary|Normalization of Esophageal Acid Exposure Time or Reduced Total Acid Exposure Time of at Least 50% Compared to the Subject's Baseline Measurement by Esophageal pH Testing.|The analysis cohort for the primary efficacy analysis was the treated population which includes all implanted subjects and was determined through esophageal pH testing.|12 Months||||participants|||Number
1460192|NCT00776997|Primary|Rate of Occurrence for Device and Procedure Related Serious Adverse Events (SAEs).|"SAE was defined as any untoward medical occurrence, whether related to the study device or procedure or not, that meets one or more of the following criteria:~Results in death~Is life-threatening~Requires subject hospitalization > 24 hours~Requires prolongation of an existing hospitalization~Results in persistent or significant disability/incapacity~Results in fetal distress, fetal death, or a congenital anomaly or birth defect~Requires intervention to prevent permanent impairment or damage.~Outcome measure reports number of subjects with reported events."|through 24 months||||participants|||Number
1460219|NCT00776984|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460193|NCT00776984|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)|||percentage of participants|||Number
1460194|NCT00776984|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Puffs||Standard Error|Mean
1460195|NCT00776984|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Days||Standard Error|Mean
1460196|NCT00776984|Secondary|ACQ Score at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1460197|NCT00776984|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Score on a scale||Standard Error|Mean
1460198|NCT00776984|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1460199|NCT00776984|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1460200|NCT00776984|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1460201|NCT00776984|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1460202|NCT00776984|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As < 50 percent (10 of 232 patients in the placebo group and 8 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1460203|NCT00776984|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
1460204|NCT00776984|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
1460205|NCT00776984|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
1461768|NCT00765375|Primary|Change in Mean Lesion Count From Baseline at 90 Days|To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)|Baseline and 90 days|All subjects completing Day 90 visit|||Lesions||Standard Deviation|Mean
1460206|NCT00776984|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
1460207|NCT00776984|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As < 50 percent (81 of 232 patients in the placebo group and 69 of 216 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1460208|NCT00776984|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Percent||Standard Error|Mean
1460209|NCT00776984|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1460210|NCT00776984|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1460211|NCT00776984|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1460212|NCT00776984|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1460213|NCT00776984|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460214|NCT00776984|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460215|NCT00776984|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460216|NCT00776984|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460217|NCT00776984|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460218|NCT00776984|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1506262|NCT00425269|Secondary|High-Density Lipoprotein Cholesterol, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1460220|NCT00776984|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460221|NCT00776984|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460222|NCT00776984|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460223|NCT00776984|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||Days||Inter-Quartile Range|Median
1460224|NCT00776984|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460225|NCT00776984|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.|||Liter||Standard Error|Mean
1460226|NCT00776919|Secondary|Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation|An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product.|Baseline (Day 1) through Week 12|ITT Population|||participants|||Number
1460227|NCT00776919|Secondary|Mean Duration of Study Product Use|Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product.|Baseline (Day 1) through Week 12|ITT Population|||days||Standard Deviation|Mean
1460228|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging|Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.|||scores on a scale||Standard Deviation|Mean
1460229|NCT00776919|Secondary|Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling|Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline.|Baseline; Weeks 2, 4, 8, and 12|ITT Population. Only those participants with data available at both Baseline and the indicated assessment week were analyzed.|||scores on a scale||Standard Deviation|Mean
1460230|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Pulse Rate|Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Beats per minute (bpm)||Standard Deviation|Mean
1460231|NCT00776919|Secondary|Mean Change From Baseline to Week 12 in Temperature|Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline.|Baseline (Day 1) and Week 12|ITT Population. Only those participants with data available at both Baseline and Week 12 were analyzed.|||Degrees centigrade||Standard Deviation|Mean
1506263|NCT00425269|Secondary|Insulin, 2-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1460233|NCT00776919|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an ISGA score >=2.|||participants|||Number
1460234|NCT00776919|Secondary|Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12|During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate.|Week 12|ITT Population. Participants with missing Week 12 evaluations were considered failures. Failures were defined as those participants with an SGA score >=2.|||participants|||Number
1460235|NCT00776919|Secondary|Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory)|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||Percent change in lesion counts||Standard Deviation|Mean
1460236|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Total Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||lesion counts||Standard Deviation|Mean
1460237|NCT00776919|Primary|Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin).|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or who reported they had lost their medication and never began treatment were excluded from the analysis. Missing values for all other participants were imputed using the LOCF method.|||lesion counts||Standard Deviation|Mean
1460238|NCT00776919|Primary|Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts|During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method.|Baseline (Day 1) and Week 12|ITT Population. Participants who missed >=16 days of treatment or reported lost medication and never began treatment were excluded from the analysis. In the LOCF method, the last available observation, including BL, was used to estimate subsequent missing data points.|||lesion counts||Standard Deviation|Mean
1460239|NCT00776919|Primary|Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L.|Baseline (Day 1) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least 1 application of study product. Participants with missing Week 12 evaluations were considered failures. Failures are defined as those participants with a 1-grade improvement, no improvement, or a worsening.|||participants|||Number
1460240|NCT00776789|Secondary|Breast Feeding Status at 6 Weeks|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases|6 weeks||||percentage of partcipants|||Number
1460257|NCT00776555|Primary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
1460241|NCT00776789|Secondary|Breast Feeding Status at 48 Hours|The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases.|48 hours|EBF rates were assessed using the standard WHO definitions. We asked the mothers about the method of feeding and the number and amount of supplemental feeds received in the first 2 days of life. Breastfeeding rates at 6 weeks were obtained by enquiring from the mothers at the time of the first vaccination of their infants in the follow-up clinic.|||percentage of partcipants|||Number
1460242|NCT00776789|Secondary|Salivary Cortisol|Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA).|6 hours||||microgram/dl||Inter-Quartile Range|Median
1460243|NCT00776789|Primary|The Median Breast Feeding Score|This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure [0 to 3] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more >=8.|36-48 hours by video recording||||scores||Inter-Quartile Range|Median
1460244|NCT00776659|Primary|Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.||||||
1460245|NCT00776659|Primary|Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42||Baseline, Month 6, 12, 18, 24, 30, 36, 42|Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.||||||
1460246|NCT00776659|Primary|Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.|Baseline up to 28 days after last dose of study treatment|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
1460247|NCT00776659|Primary|Number of Participants Who Discontinued Aromasin Therapy||Baseline until discontinuation (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
1460248|NCT00776659|Primary|Number of Participants Who Died||Baseline until death (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy.|||participants|||Number
1460249|NCT00776659|Primary|Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer||Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)|FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1460250|NCT00776659|Primary|Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer|Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.|Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
1460251|NCT00776594|Secondary|Analysis of Cytokines and Angiogenic Factors in Plasma/Serum|Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).|6 months||||pg/ml||Inter-Quartile Range|Median
1460252|NCT00776594|Secondary|Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).|The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.|6 months||||participants|||Number
1460253|NCT00776594|Secondary|Number of Participants With PSA <0.2 ng/ml at Six Months|Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).|Six months (at completion of treatment)||||Number of participants|||Number
1460254|NCT00776594|Primary|Relapse-free Survival|To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.|2 years||||months||95% Confidence Interval|Median
1460255|NCT00776555|Secondary|DRQ-S, Question 3|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose|Analysis not performed because of the study's premature termination.||||||
1460258|NCT00776295|Secondary|3 Year Progression-free Survival|3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC|up to 3 years||||participants|||Number
1474320|NCT00674466|Secondary|Reduction in Fasting Body Weight From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||kg||Standard Deviation|Mean
1460262|NCT00776100|Secondary|Duration of Response|Duration of response was defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1460263|NCT00776100|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the date at which the patient was removed from treatment (Arm II) or no treatment (Arm I) due to progression, adverse events, or refusal.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1460264|NCT00776100|Secondary|Time to Disease Progression|Time to disease progression was defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.|Time from registration to disease progression (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1460265|NCT00776100|Secondary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first of either death due to any cause or progression.|Time from registration to disease progression or death (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1460266|NCT00776100|Secondary|Response Rate|A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations around 3 months apart. All participants with measurable disease (non-CR at baseline, etc.), meeting the eligibility criteria who have signed a consent form and have started the study were evaluable for response.|Up to 5 years|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1460267|NCT00776100|Primary|Overall Survival|Overall survival was defined as the time from registration to the date of death or last follow-up|Time from registration to death or last follow-up (up to 5 years)|Study terminated prematurely. Planned analyses was not performed. The data collected was not summarized in the data table due to the protected health information would specifically identify the study participants.||||||
1460268|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement.|||Number correct||Standard Error|Least Squares Mean
1460269|NCT00776009|Secondary|Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose|Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to “academic productivity.” A positive score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Number attempted||Standard Error|Least Squares Mean
1460270|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
1460271|NCT00776009|Secondary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
1466362|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1460272|NCT00776009|Primary|Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose|SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.|Pre-dose to 10, 11, and 12 hours post-dose|Intent-to-treat population included all randomized patients who took at least 1 dose of study medication and who had at least 1 post-dose efficacy measurement|||Scores on a scale||Standard Error|Least Squares Mean
1460273|NCT00775983|Secondary|Participants Who Experienced Complications or Need for Additional Dilation|Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.|||participants|||Number
1460274|NCT00775983|Primary|Procedure Time|Procedure time to complete early second-trimester dilation and evacuation (D&E)|Day of procedure|All patients who received a surgical abortion procedure were analyzed. Since three patients did not actually obtain an abortion within the study timeframe, we could not analyze their data, thus the analysis was per protocol.|||minutes||Standard Error|Mean
1460275|NCT00775944|Secondary|Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)|Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.|Measured 6 months after participant's quit date|||||||
1460276|NCT00775944|Secondary|Health Status at 6 Months EuroQol 5D (EQ5D)|This is a generic measure of health status used in health economic analyses.|Measured 6 months after participant's quit date|||||||
1460277|NCT00775944|Secondary|Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months|As title|Measured 6 months after participant's quit date|||||||
1460278|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month|Participants had to report not smoking for 7 or more days prior to outcome ascertainment.|Measured at 1 month after participant's quit date|All randomised cases|||participants|||Number
1460279|NCT00775944|Secondary|Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month|Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked.|Measured at 1 month after participant's quit date|All randomised cases|||participants|||Number
1460280|NCT00775944|Secondary|Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months|Participants had to report not smoking in the three months prior to outcome ascertainment.|Measured at 6 months after participant's quit date|All randomised cases|||participants|||Number
1460281|NCT00775944|Secondary|Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.|The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.|Measured 6 months after participant's quit date||||participants|||Number
1460282|NCT00775944|Primary|Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.|Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period.|6 months from participant's quit date|All randomised cases|||participants|||Number
1460283|NCT00775684|Primary|Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL)|AGRmin is performed during the 340mg/dl glucose clamp allows for estimation of the minimum alpha-cell glucagon secretion. Changes from baseline to 6 months of AGRmin were compared across groups.|Baseline and 6 months|"We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months."|||pg/mL||Standard Error|Mean
1460284|NCT00775684|Secondary|PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months|Between ∼60 and 250 mg/dL, the magnitude of AIRarg is a linear function of the plasma glucose level, so the difference in AIRarg at fasting and 230 mg/dL glucose levels divided by the difference in plasma glucose (ΔAIRarg/ΔPG) gives the glucose-potentiation slope (GPS) (8,24–26). Using the y-intercept (b) from the line created by these two points, the plasma glucose level at which half-maximal insulin secretion is achieved (PG50) is derived from solving the equation 1/2 (AIRmax) = (GPS · PG50) + b, and provides a measure of β-cell sensitivity to glucose The mean difference after 6 months in PG 50 were compared. Listed below are the PG50 values at baseline and 6 months.|Baseline and 6 months||||mg/dL||Standard Error|Mean
1460285|NCT00775684|Secondary|Insulin Sensitivity at Baseline and 6 Months|Insulin sensitivity (M/I) was determined by dividing the mean glucose infusion rate required during the 230 mg/dL glucose clamp (M) by the mean prestimulus insulin level (I) between 40 and 45 min of the glucose infusion The mean difference after 6 months in insulin sensitivity (M/I) were compared|Baseline and 6 months||||((mg/kg) /min) /uU/mL||Standard Error|Mean
1460286|NCT00775684|Secondary|Change in Acute Insulin Response to Arginine. (AIRarg)|The changes in B-cell insulin secretion, Acute Insulin Response to arginine (AIRarg) after 6 months were compared to baseline AIRarg for each group. Listed below are AIRarg at baseline and 6 months for each group.|Baseline and 6 months||||uU/mL||Standard Error|Mean
1460312|NCT00775528|Secondary|Stool Fat (% Fat)|The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).|Last 3 days in a 10-day treatment period|The efficacy results are presented on the Full Analysis Set meaning patients having taken the study drug and with Post-baseline efficacy data.|||Percentage of fat||Standard Deviation|Mean
1460287|NCT00775684|Primary|Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)|The acute insulin response to arginine (AIRarg) performed during the 340mg/dl glucose clamp allows for estimation of the the beta-cell secretory capacity (AIRmax) or functional beta-cell mass. Changes from baseline to 6 months of AIRmax were compared across groups|Baseline and 6 months|"We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months."|||μU/ml||Standard Error|Mean
1460288|NCT00775671|Primary|Marker of Fibrinolysis|Concentration of plasminogen activator inhibitor 1 (PAI-1)antigen.|After 12 weeks of study drug||||ng/mL||Standard Deviation|Mean
1460289|NCT00775671|Secondary|Measurement of Insulin Sensitivity|The change in insulin sensitivity index, from baseline to after 12 weeks of treatment. Calculated from the intravenous glucose tolerance test at baseline and at 12 weeks.|3 hours||||10-4xmin-1 per mU/L||Standard Deviation|Mean
1460290|NCT00775658|Primary|The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.|||cm2||Standard Deviation|Mean
1460291|NCT00775658|Primary|The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.||at baseline and at return visit (between study day 7-10)||||cm2||Standard Deviation|Mean
1460292|NCT00775645|Other Pre-specified|Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy|Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1460293|NCT00775645|Other Pre-specified|Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status|Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1460294|NCT00775645|Other Pre-specified|Treatment and Concurrent Therapy|total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines|12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1460295|NCT00775645|Other Pre-specified|Serum Nerve Growth Factor Levels||12 weeks post-registration|Data still in process; Analysis to be performed in future.||||||
1460296|NCT00775645|Other Pre-specified|Proportion of Patients Experiencing Grade 3 or 4 Neuropathy|Proportion of patients experiencing grade 3 or 4 neuropathy|12 weeks post-registration||||Participants|||Count of Participants
1460297|NCT00775645|Secondary|12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups|Compare fatigue outcome between treatment and placebo groups as measured by the 13-item Functional Assessment of Chronic Illness Therapy FACIT-fatigue questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate more fatigue. Total possible range is 0 to 52. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||FACIT-fatigue score||Full Range|Mean
1460298|NCT00775645|Secondary|12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups|Compare FACT-TOI outcome in treatment vs placebo groups at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse functional status. Total possible range is 0 to 120. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||units on a scale||Full Range|Mean
1460299|NCT00775645|Primary|12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups|Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires|12 weeks post-registration||||units on a scale||Full Range|Mean
1460300|NCT00775606|Secondary|Response to Immunization With Pneumococcus Polysaccharide and Tetanus-diphtheria Vaccines|Response to immunization with pneumococcus polysaccharide and tetanus-diphtheria vaccines was not done due to small sample size|4 weeks after treatment initiation|||||||
1460301|NCT00775606|Secondary|Activated and Regulatory CD4+ and CD8+ T-cell Frequencies||4, 12 and 24 weeks after treatment initiation|||||||
1460302|NCT00775606|Secondary|Naive, Central Memory and Effector Memory CD4+ and CD8+ (Cluster of Differentiation 8) T-cell Frequency||4, 12 and 24 weeks after treatment initiation|||||||
1460303|NCT00775606|Secondary|CD4+ T-cell Change|This measures the change in CD4+ T-cells from baseline to week 24 of treatment.|24 weeks after treatment initiation (baseline and week 24)||||cells/mm3||Standard Deviation|Mean
1460304|NCT00775606|Primary|CD4+ (Cluster of Differentiation 4) T-cell Apoptosis|Change in the percentage of naive CD4 T-cells undergoing apoptosis as measured by propidium iodide staining. This is a lab test that measures the percentage of naive CD4 T-cells that are undergoing cell death. The change in this measure is obtained by determining the difference between the percentage of naive CD4 T-cells undergoing apoptosis at week 24 of treatment and the percentage undergoing apoptosis at baseline.|24 weeks from treatment initiation (baseline and week 24)||||per cent||Standard Deviation|Mean
1460305|NCT00775593|Secondary|Duration of Survival||At 2 years from study entry||||months||Full Range|Median
1460306|NCT00775593|Secondary|Duration of Response|Participants who responded to treatment|At 2 years from study entry||||months||Standard Deviation|Mean
1460307|NCT00775593|Secondary|Number of Serious Adverse Events Within 2 Years||At 2 years from study entry||||serious adverse events|||Number
1460313|NCT00775463|Secondary|Time to Ulcer Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial. The time to complete healing of all ulcers were calculated as the number of days from randomization to the date of these respective assessments, provided that complete healing was achieved during the study.|Week 20||||days||Standard Deviation|Mean
1460314|NCT00775463|Secondary|Time to Ulcer Healing- Percentage of Subjects With Complete Healing|A subject was counted as having all ulcers completely healed at the earliest assessment for which all ulcers are designated as “healed” and no new ulcers appeared for the remainder of the trial.|Week 20||||percentage of participants|||Number
1460315|NCT00775463|Secondary|Short Form 36|Change in patient quality of life was measured by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), a self-administered questionnaire covering eight areas: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health. For each area, the score range from 0 (poorer health status) to 100 (better health status). The SF-36 is one of the most widely used and validated instruments to assess quality of life in patients with systemic illnesses. A decrease (negative change) in a domain score corresponds to deterioration.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1460316|NCT00775463|Secondary|Patient Impression of Change (PIC) Questionnaire|The PIC questionnaire consisted of three Likert items that asked the subject to rate changes in their digital ulcer, Raynaud’s phenomenon and disease status since their last visit on a seven-level scale (very much improved, much improved, somewhat improved, same, somewhat worse, much worse and very much worse).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||participants|||Number
1460317|NCT00775463|Secondary|Short-Form McGill Pain Questionnaire|The SF-MPQ assessment has three component scores: the pain rating index (PRI), a pain visual analogue numerical scale (Pain VAS) and the present pain intensity (PPI). PRI is calculated by summing the responses (0=None to 3=Severe) to the 15 questions describing pain during the previous week and rated on an intensity scale as 0= none, 1= mild, 2= moderate or 3= severe and has possible values ranging from 0 to 45. The Pain VAS is a 100 mm VAS on which subjects were asked to rate pain during the previous week with values ranging from no pain (0.0) to worst possible pain (10.0). The PPI rated pain on a 6-point category scale from 0 (no pain) to 5 (excruciating pain).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1460318|NCT00775463|Secondary|Modified Rodnan Skin Score (mRSS)|The skin thickening was assessed by the Investigator in 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each area was scored 0–3; 0 representing normal skin and 3 being severe thickening. The mRSS was the sum of the individual skin assessment scores: possible range of 0-51; 0 (no thickening) to 51 (severe thickening in all 17 areas) .|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1460319|NCT00775463|Secondary|Scleroderma Health Assessment Questionnaire (SHAQ)|The SHAQ is a patient self-administered instrument which has been previously validated in SSc and demonstrates meaningful clinical changes in the course of the disease over time. It is comprised of a 20 question instrument pertaining to specific activities with possible integer responses of 0 (without any difficulty) to 3 (unable to do), and five additional scleroderma-specific visual analog scale (VAS) domains (Overall Disease Activity, Raynaud’s Phenomenon, Finger Ulcers, Breathing, and Intestinal Problems) with possible values ranging from 0.0 to 15.0. The 20 questions are divided into eight domains. A mean score is calculated for each domain ranging from 0 to 3. A composite HAQ DI score is calculated by dividing the summed domain scores by the number of domains answered. The composite score is reported, falling between 0 and 3 on an ordinal scale. The scores are interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1460320|NCT00775463|Secondary|Cochin Hand Function Scale (CHFS)|The CHFS has been demonstrated as a reliable and valid assessment of hand function at the activity level in persons with SSc. It is comprised of 18 questions with possible integer responses of 0 (without difficulty) to 5 (impossible). The CHFS Score is simply the sum of all 18 questions, divided by the number of questions actually answered, multiplied by 18. At least 10 of the 18 questions must have been answered in order for CHFS to be calculated. Therefore, CHFS Score values can range from 0 (least limitation) to 90 (most limitation). A higher score indicates more difficulty in hand function or greater disability.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||95% Confidence Interval|Median
1460357|NCT00775437|Secondary|Uric Acid: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
1460321|NCT00775463|Secondary|Physician Global Assessment of Digital Ulcer Severity VAS|"Physicians rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1460322|NCT00775463|Secondary|Patient Global Assessment of Digital Ulcer Severity VAS|"Patients rated their global impression of digital ulcer severity on a 15-cm VAS from scaled 0 (no disease activity) to 100 (very severe disease).~The term “severity” was used to measure the extent of disease activity and associated disability or discomfort the patient experienced during the indicated time period."|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1460323|NCT00775463|Secondary|Digital Ulcer Pain VAS|Digital ulcer pain was rated on a 100-mm VAS on which subjects were asked to rate their average overall hand pain during the last week. The recorded value was divided by 10, with values ranging from 0.0 (no pain) to 10.0 (unbearable pain), expressed to one decimal.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change. Excluded subjects without a Baseline observation|||units on a scale||Inter-Quartile Range|Median
1460324|NCT00775463|Primary|Net Ulcer Burden|Net ulcer burden was defined as the number of “new” or “active” digital ulcers (DU), plus the number of “indeterminate” DUs at that assessment that have previously been classified as either “active” or “new” at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced “active.” If denudation could not be judged because of the presence of scab or necrotic tissue, DU presenting with features, including underlying pain, based on Investigator clinical judgment to be consistent with loss of epithelialization, epidermis, or dermis, and requiring treatment were designated as “active.” Otherwise, the DU was pronounced “indeterminate.” Only DUs distal to the proximal interphalangeal joints, volar to the equator of the finger, not localized in creases and vascular in origin were assessed.|Week 20|The intent to treat population is all subjects that received at least one dose of study drug. Subjects were counted in the assigned group regardless of the actual treatment given. Missing values imputed by carrying last observation forward or assigning value equalling overall poorest relative change.|||ulcers||Inter-Quartile Range|Median
1460325|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.|Day 28 post vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
1460326|NCT00775450|Secondary|Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine|Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.|Days 0 and 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Percentage of Participants|||Number
1460327|NCT00775450|Secondary|Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.|Day 0 and Day 28 post-vaccination|Serum antibody titers were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1460328|NCT00775450|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection|Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.|Days 0 through 7 post vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Participants|||Number
1460329|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460330|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1465462|NCT00736502|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Calculated as CD4+ cell count at week 48 minus the baseline value|Baseline and week 48|TS with non-missing data at baseline and week 48|||Cells/mm^3||Standard Deviation|Mean
1460331|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460332|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460333|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460334|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460335|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460336|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460337|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460338|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460339|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1463211|NCT00756275|Primary|7-day Point-prevalence Smoking Abstinence|7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml.|3 month follow up|"Intent to Treat Note: People who were lost were counted as smoked"|||participants|||Number
1460340|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460341|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460342|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.||||units on a scale||Standard Deviation|Mean
1460343|NCT00775437|Secondary|Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change From Baseline to Each Visit|The CHQ-PF50 is a participant-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460344|NCT00775437|Secondary|Pain on Passive Motion (POM75) Joint Count: Mean Change From Baseline to Each Visit|"Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460345|NCT00775437|Secondary|Swollen Joint Count (SJC66): Mean Change From Baseline to Each Visit|"Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present (1), absent (0) or replaced/injected (9). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460346|NCT00775437|Secondary|Tender Joint Count (TJC75): Mean Change From Baseline to Each Visit|"Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present (1), absent (0) or replaced/injected (9). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460347|NCT00775437|Secondary|C-reactive Protein (CRP): Mean Change From Baseline to Each Visit|CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||mg/dL||Standard Deviation|Mean
1460348|NCT00775437|Secondary|Limitation of Passive Motion (LOM69) Joint Count: Mean Change From Baseline to Each Visit|"Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present (1), absent (0), or replaced/injected (9). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1461842|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1460349|NCT00775437|Secondary|Active Joint Counts (AJC73): Mean Change From Baseline to Each Visit|A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460350|NCT00775437|Secondary|Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change From Baseline to Each Visit|The DICHAQ is a self-reported participant-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A participant must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460351|NCT00775437|Secondary|Parent's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The parent’s assessment of how the participant’s arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460352|NCT00775437|Secondary|Physician's Global Assessment of Disease Activity: Mean Change From Baseline to Each Visit|The physician’s assessment of participant's overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Participants with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=participants with a nonmissing value at baseline and each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||units on a scale||Standard Deviation|Mean
1460353|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 90% Response (PedACR90)|The PedACR90 response is defined by the PedACR as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1460354|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 70% Response (PedACR70)|The PedACR70 response is defined by the PedACR as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1460355|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 50% Response (PedACR50)|The PedACR50 response is defined by the PedACR as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1460356|NCT00775437|Secondary|Percentage of Participants Achieving Pediatric American College of Rheumatology (PedACR) 30% Response (PedACR30)|The PedACR30 response is defined by the PedACR as ≥30% improvement in at least 3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of participants for either observed or imputed methods at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||percentage of participants|||Number
1460359|NCT00775437|Secondary|Total Bilirubin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||µmol/L||Standard Deviation|Mean
1460360|NCT00775437|Secondary|Creatine Phosphokinase: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1460361|NCT00775437|Secondary|Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1460362|NCT00775437|Secondary|Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug.Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1460363|NCT00775437|Secondary|Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||U/L||Standard Deviation|Mean
1460364|NCT00775437|Secondary|Basophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1460365|NCT00775437|Secondary|Eosinophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1460366|NCT00775437|Secondary|Monocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1460367|NCT00775437|Secondary|Lymphocytes: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
1460368|NCT00775437|Secondary|Neutrophils: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
1460369|NCT00775437|Secondary|White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10^9/L||Standard Deviation|Mean
1460370|NCT00775437|Secondary|Platelets: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄9/L||Standard Deviation|Mean
1460371|NCT00775437|Secondary|Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||x10˄12/L||Standard Deviation|Mean
1460372|NCT00775437|Secondary|Hematocrit: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||Fraction||Standard Deviation|Mean
1460373|NCT00775437|Secondary|Hemoglobin: Mean Change From Baseline to Each Visit|Baseline is the last value prior to the first dose of study drug. Participants with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=participants with evaluable data at given time point.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120||||g/L||Standard Deviation|Mean
1460374|NCT00775437|Secondary|Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24|Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.|Weeks 0, 12, and 24|All participants who had samples for pharmacokinetic analysis|||µg/mL||Standard Deviation|Mean
1460415|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ELISA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1506264|NCT00425269|Secondary|Insulin, 0-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1460375|NCT00775437|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).|TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).||||participants|||Number
1460376|NCT00775411|Secondary|Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26|Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).|Baseline, Week 26|Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26.|||Percentage of participants|||Number
1460377|NCT00775411|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 26|Intent to treat population consisting of all enrolled participants.|||Number of letters||Standard Deviation|Mean
1460378|NCT00775411|Primary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.|Baseline, Week 4|Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses.|||Microns||Standard Deviation|Mean
1460379|NCT00775346|Primary|Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).|Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP).|9 Hours||||Ratio||90% Confidence Interval|Mean
1460380|NCT00775229|Secondary|Liver Function Tests|Participants were administered a general test of liver functioning to asses safety over the course of the study. Data represent the percentage of participates with Liver Function Test values falling outside of the range considered safe/typical for liver functioning at any of the assessed time points. It was performed at baseline and at each visit where dosage of the medication is >50mg/day (week 2-week 8).|Week 8 (last visit)||||percentage of individuals with LFT chang|||Number
1460381|NCT00775229|Secondary|Massachusetts General Hospital Hairpulling Scale|Ranges from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).||||units on a scale||Standard Deviation|Mean
1460382|NCT00775229|Primary|National Institute of Mental Health Trichotillomania Symptom Severity Scale|Ranges from 0-20 with 20 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 8 weeks. The final total score is reported here.|This is the final score, measured at week 8 (final visit).||||units on a scale||Standard Deviation|Mean
1460383|NCT00775203|Secondary|Discontinuation Due to Lack of Efficacy|Number of patients who discontinued due to lack of efficacy during the whole study period (8 weeks).|Baseline to Week 8|Safety population is defined as all randomized patients who received any study medication.|||participants|||Number
1460384|NCT00775203|Secondary|Awakening During the Night at Each Visit|"Awakening during the night was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit did you awaken during the night?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1460385|NCT00775203|Secondary|Trouble Falling Asleep at Each Visit|"Trouble Falling Asleep was measured on a 4-point rating scale ranging from 1 = never to 4 = always in response to the question: Since the last study visit, how often did you experience trouble falling asleep?."|Weeks 1, 2, 3, 4, 6, 8|Full Analysis set (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on a scale||Standard Deviation|Mean
1460386|NCT00775203|Secondary|Overall Quality of Sleep at Each Visit|"Overall Quality of Sleep was measured on a 4-point rating scale ranging from 1 = very poor to 4 = excellent in response to the question: Since the last study visit, how would you rate the overall quality of your sleep?."|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Points on a scale||Standard Deviation|Mean
1465497|NCT00736450|Primary|Number of Participants With Microarray Testing Results Are Completed Within 7 Days.||Upto 7 days||||Participants|||Count of Participants
1460387|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Responders at Last Study Visit|Patients were responders if the PGI-I rating was “Much Improved” or “Very Much Improved”. The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Responders Week 8 Observed Cases: Trazodone = 176, placebo = 183.|||participants|||Number
1460388|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Responders at Last Study Visit|Patients were responders if the CGI-I rating was “Much Improved” or “Very Much Improved”. The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse. Results are expressed in number of patients.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Responders Week 8 Observed Cases: Trazodone = 180, placebo = 183.|||participants|||Number
1460389|NCT00775203|Secondary|Patient Global Impression – Improvement of Illness (PGI-I) Score at Last Study Visit|The PGI-Improvement of Illness (PGI-I) consists of one question for the patient: “Since the start of the study, my overall status with regard to depression is?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. PGI-I Week 8 Observed Cases: Trazodone = 176, placebo = 183.|||Units on PGI-I scale||Standard Deviation|Mean
1460390|NCT00775203|Secondary|Clinical Global Impression – Improvement of Illness (CGI-I) Score at Last Study Visit|The CGI-Improvement of Illness (CGI-I) consists of one question for the investigator: “Compared to his condition at the start of the study, how much has this patient changed?” which is rated on the following seven-point scale 1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse.|Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. CGI-I Week 8 Observed Cases: Trazodone = 178, placebo = 182.|||Units on the CGI-I scale||Standard Deviation|Mean
1460391|NCT00775203|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Each Visit|The CGI-Severity (CGI-S) consists of one question for the investigator: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” which is rated on the following seven-point scale: 1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Units on CGI-S scale||Standard Deviation|Mean
1460392|NCT00775203|Secondary|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10 item clinician-administered depression rating scale. The 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts) are rated on a scale ranging from 0 (low severity/difficulty) to 6 (high severity/difficulty) with anchors at 2-point intervals. The overall total score range is from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. MADRS Week 8 Observed Cases: Trazodone = 178, placebo = 182.|||Units on MADRS scale||Standard Deviation|Mean
1460393|NCT00775203|Secondary|Change in HAMD-17 Depressed Mood Item (Item 1) Score From Baseline to Each Visit|Change from baseline in the HAMD-17, item 1: Depressed Mood item, at each post-baseline visit. The Depressed Mood item is rated on a 5-point scale ranging from rating of 0=absent; to 4=very severe.|Baseline to Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Points on the HAMD scale||Standard Deviation|Mean
1460394|NCT00775203|Secondary|HAMD-17 Remitters at Each Visit|Number of patients who are remitters (defined as patients who achieved a HAMD-17 total score ≤7) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Participants|||Number
1460395|NCT00775203|Secondary|HAMD-17 Responders at Each Visit|Number of patients who show a response (defined as at least a 50% reduction from baseline in HAMD-17 score) at each post-baseline visit.|Weeks 1, 2, 3, 4, 6, 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Last Observation Carried Forward (LOCF).|||Participants|||Number
1460416|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by CLIA.|Cut-off values assessed were as follows: ≥6.2 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1465498|NCT00736450|Primary|Time to Perform Microarray Study After Receipt of Tissue|The time from tissue harvest to release of microarray test and IHC assay results will be noted in days.|Upto 14 days||||days||Full Range|Mean
1460396|NCT00775203|Primary|Change in Hamilton Depression Scale (HAMD-17) Total Score From Baseline|The Hamilton Depression Rating Scale 17 items [HAMD-17] is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17score ranges from 0 (not ill) to 52 (severely ill).|Baseline to Week 8|Full analysis (intent-to-treat [ITT]) population is defined as all randomized patients who received any study medication and had a baseline and at least one post-baseline HAMD-17 assessment. Week 8 Last Observation Carried Forward (LOCF): Trazodone = 202, placebo = 204.|||Points on HAMD-17 scale||Standard Deviation|Mean
1460397|NCT00775190|Secondary|Side Effects (Incidence of Thromboembolic Events)|Occurrence of any thromboembolic events during the study time frame.|6 months|Study Terminated with no data analysis||||||
1460398|NCT00775190|Secondary|Side Effects (Menstrual Cramps)|Intensity of menstrual cramps reported on a 4 point Likert scale.|6 months|Study Terminated with no data analysis||||||
1460399|NCT00775190|Secondary|Side Effects (Mood Changes)|Self reported changes in mood during each month over the time frame.|6 months|Study Terminated with no data analysis||||||
1460400|NCT00775190|Secondary|Side Effects (Breast Tenderness)|Incidence of breast tenderness during the study time frame|6 Months|Study Terminated with no data analysis||||||
1460401|NCT00775190|Secondary|Side Effects (Vomiting)|Number of episodes of vomitting|6 Months|Study Terminated with no data analysis||||||
1460402|NCT00775190|Secondary|Side Effects (Nausea)|Number of days of nausea|6 months|Study Terminated with no data analysis||||||
1460403|NCT00775190|Primary|Days of Bleeding|Number of days with bleeding during each menstrual period.|6 months|Study Terminated with no data analysis||||||
1460404|NCT00775190|Primary|Incidence of Breakthrough Bleeding|Any breakthrough bleeding during reporting period.|6 months|Study Terminated with no data analysis||||||
1460405|NCT00775190|Primary|Amount of Bleeding|Measures how light or heavy the menstrual flow on a 1 to 3 Likert scale. (Light, Medium, Heavy).|6 Months|Study Terminated with no data analysis.||||||
1460406|NCT00775021|Secondary|Overall Lens Handling|Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1460407|NCT00775021|Secondary|Initial Comfort|Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 Week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1460408|NCT00775021|Secondary|End of the Day Comfort|Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1460409|NCT00775021|Secondary|Inferior Region Corneal Staining|The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1460410|NCT00775021|Primary|Overall Comfort|Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.|1 week|Analysis includes all participants that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1460411|NCT00774995|Secondary|Number of Subjects That Experienced Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period after the challenge dose (1 month).||||Subjects|||Number
1460412|NCT00774995|Secondary|Number of Subjects Experiencing Any, Grade 3 and Related to Vaccination Unsolicited Symptoms.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 symptom is any event that prevented normal activities. Related symptom is an event that was considered by investigator as causally related to the study vaccination.|During the 31-day follow-up period after the hepatitis B vaccine challenge dose.||||Subjects|||Number
1460413|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by ChemiLuminescence ImmunoAssay (CLIA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1460414|NCT00774995|Secondary|Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by CLIA.|Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
1460453|NCT00774787|Post-Hoc|Complete Clearance of Actinic Keratoses at 4-8 Weeks Post-treatment|Complete clearance (actinic keratosis count of 0) in each respective area at 4-8 weeks post-treatment. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|4-8 weeks post-treatment|All patients enrolled.|||Participants|Participants||Number
1460417|NCT00774995|Secondary|Number of Subjects With Anti-Hepatitis B Surface (HBs) Antibody Concentrations Above Cut-off Values as Measured by ELISA.|Cut-off values assessed were as follows: ≥3.3 milli-international units/milliliter (mIU/mL), ≥10 mIU/mL, ≥100 mIU/mL|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1460418|NCT00774995|Primary|Number of Subjects With an Anamnestic Response to a Challenge Dose of Hepatitis B Virus (HBV) Vaccine as Measured by Enzyme-Linked Immunosorbent Assay (ELISA).|Anamnestic response to the challenge dose is defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge anti-HBsAg antibody concentrations in subjects seropositive at the last available follow-up time-point. -Post-challenge dose anti-HBsAg antibody concentrations >= 10 mIU/mL in subjects seronegative at the last available follow-up time-point.|One month after the hepatitis B vaccine challenge dose.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the challenge dose of HBV vaccine and for whom data concerning immunogenicity measures were available at the post-HBV vaccine challenge dose time point.|||Subjects|||Number
1460419|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||μmol/day||Standard Deviation|Mean
1460420|NCT00774930|Secondary|Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA])|Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||μg/L||Standard Deviation|Mean
1460421|NCT00774930|Secondary|Changes From Baseline in QoL in “Endocrine Symptoms” Subscore (Assessed Based on Items Q31, Q32 and Q33 Using EORTC QLQ-G.I.NET-21 Questionnaires)|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
1460422|NCT00774930|Secondary|Changes From Baseline in “Gastrointestinal (G.I). Symptoms” Subscore (Based on Items Q34, Q35, Q36, Q37 and Q38 of EORTC G.I. Neuroendocrine Tumour [NET] 21]|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~The QLQ-G.I.NET21 questionnaire contains 21 single items (Q31 to Q51) which are supplemental items to the EORTC QLQ-C30 questionnaire. Q31 to Q51 range from 1 to 4 with 1 being the most favourable answer and 4 the worst case (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much). Based on these items the scores were generated. All of the scores range in score from 0 to 100. A high score for a symptom scale represents a high level of symptomatology. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. RS = (I1 + I2 +…+ In)/n.~For symptom scales: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
1460423|NCT00774930|Secondary|"Changes From Baseline in Global Health Status/Quality of Life (QoL) Score (Based on Items 29 and 30 of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ] C30)"|"Baseline is defined as the last non-missing observation obtained prior to the initiation of study treatment.~Q29 and Q30 range from 1 (Very poor) to 7 (Excellent) with 1 being worst case and 7 the most favourable answer. Scores were derived according to the rules contained within the EORTC scoring manual. All of the scores range in score from 0 to 100. A high score for global health status/QoL represents high QoL. The principle for scoring the scale is: Estimate the average of the items (I1, I2, ..., In) that contribute to the scale; this is the raw score. Raw score = RS = (I1 + I2 +…+ In)/n.~For global health status/QoL: Score = {(RS - 1)/range} x 100, where range is the difference between the maximum possible value of RS and the minimum possible value of RS."|Baseline and Week 12 of DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group); n=number of subjects taken into account for the analysis. Only the observed data are used in the calculation. The missing data are excluded from the analysis.|||Units on a scale||Standard Deviation|Mean
1460424|NCT00774930|Secondary|Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study|Subjects who rolled over early were those who received less than four DB injections before receiving the first IOL injection.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of subjects|||Number
1474321|NCT00674466|Secondary|Reduction in Fasting Plasma Glucose From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||mg/dL||Standard Deviation|Mean
1460425|NCT00774930|Secondary|Percentage of Days of Use of Other Rescue Medication|Usage of other concomitant rescue medications for diarrhoea and/or flushing events, measured as the percentage of days that the medications were used as rescue medication based on subject IVRS/IWRS diary records. Subjects were required to record the use and dose of s.c. octreotide, if any, as well as the use of other concomitant rescue medications (e.g. loperamide 2 mg tabs, and/or tincture of opium).|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of days||Standard Deviation|Mean
1460426|NCT00774930|Secondary|Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Number of events per day||Standard Deviation|Mean
1460427|NCT00774930|Secondary|Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records.||16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Number of events per day||Standard Deviation|Mean
1460428|NCT00774930|Primary|Percentage of Days With Subcutaneous Octreotide as Rescue Medication|Use of s.c. octreotide required to control symptoms associated with carcinoid syndrome, measured as the percentage of days that s.c. octreotide was used as rescue medication, based on subject Interactive Voice Response System (IVRS) or Interactive Web Response System (IWRS) diary records.|16-week DB phase|ITT population: All randomised subjects (regardless of whether the subjects received or adhered to the allocated treatment group). Subjects from the ITT population were analysed under the randomised treatment group.|||Percentage of days||95% Confidence Interval|Least Squares Mean
1460429|NCT00774852|Secondary|Proportion of Vaccinated Participants With a Competent Immune Response|"Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:~Pneumococcal vaccination response – absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.~Tetanus toxoid vaccination response – absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer~Competent immune response is indicative of low disease activity."|Week 52|Intent-to-treat who completed Week 52 and were vaccinated.|||percentage of participants|||Number
1460430|NCT00774852|Secondary|Lupus Disease Activity – Total BILAG-2004|BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.|Week 52|Intent-to-treat who completed Week 52 and BILAG 2004 data available.|||units on a scale||Standard Deviation|Mean
1460431|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.|||percent change||Standard Deviation|Mean
1460432|NCT00774852|Secondary|Lupus Disease Activity – SF-36 Scores|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life."|Week 104|Intent-to-treat who completed Week 104 and had SF-36 data available.|||Score||Standard Deviation|Mean
1460433|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment Percent Change From Baseline|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.|||percent change||Standard Deviation|Mean
1460467|NCT00774397|Secondary|Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients|Baseline is defined as the last value before the drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24)|||U/L||Standard Deviation|Mean
1506265|NCT00425269|Secondary|C-peptid, 2-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1460434|NCT00774852|Secondary|Lupus Disease Activity – Patient Global Assessment|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.~PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease."|Week 104|Intent-to-treat who completed Week 104 and had patient global assessment data available.|||units on a scale||Standard Deviation|Mean
1460435|NCT00774852|Secondary|Lupus Disease Activity – Frequency of Flares|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity."|Week 52|Intent-to-treat with available data between weeks 24 and 52.|||participants|||Number
1460436|NCT00774852|Secondary|Lupus Disease Activity – Presence of Hypocomplementemia|"Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus."|Week 104|Intent-to-treat participants who completed Week 104 and had hypocomplementemia data available|||participants|||Number
1460437|NCT00774852|Secondary|Lupus Disease Activity – Negative Anti-dsDNA|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity."|Week 104|Intent-to-treat participants who completed Week 104.|||participants|||Number
1460438|NCT00774852|Secondary|Lupus Disease Activity – Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104|"Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.~Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity."|Week 104|Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104.|||participants|||Number
1460439|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response|A participant who did not meet the criteria for either a complete response (CR) or a partial response (PR) at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the investigator judged that the participant may benefit from continued participation. CR definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a CR. PR definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline, and prednisone dose has been tapered to 10 mg/day.|Week 52|Intent-to-treat||||||
1460440|NCT00774852|Secondary|Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study|A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe.|Week 104|Intent-to-treat|||participants|||Number
1460441|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response|A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1460442|NCT00774852|Secondary|Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response|A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1460468|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils|Number of patients with normal or high baseline moved to low .|Baseline and Week 24|Treated Set (for patients with normal or high baseline Absolute Neutrophils)|||percentage of patients|||Number
1460469|NCT00774397|Secondary|Change From Baseline to Week 24 in Absolute Neutrophils of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24)|||GI/L||Standard Deviation|Mean
1460443|NCT00774852|Secondary|Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis.|Week 52|Intent-to-treat|||participants|||Number
1460444|NCT00774852|Secondary|Number of Participants With a Complete or Partial Response|"Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.~Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.~Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis."|Week 52|Intent-to-treat|||participants|||Number
1460445|NCT00774852|Secondary|Number of Participants With Partial Response|Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1460446|NCT00774852|Primary|Number of Participants With Complete Response|Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.|Week 24|Intent-to-treat|||participants|||Number
1460447|NCT00774800|Secondary|Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])|AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose.|Predose up to 4 hours after injection of study drug|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC(BG) data.|||minutes*milligrams per deciliter||90% Confidence Interval|Geometric Mean
1460448|NCT00774800|Secondary|Time to Maximum Serum Insulin Concentration (Tmax)|Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable tmax data.|||minutes||Standard Deviation|Mean
1460449|NCT00774800|Secondary|Maximum Serum Insulin Concentration (Cmax)|Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.|Predose up to 480 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable Cmax data|||Picomoles per liter (pmol/L)||Standard Deviation|Mean
1460450|NCT00774800|Primary|Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)|AUC was derived as the area under the serum insulin concentration profile from 0 to time “t.” Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose.|Predose up to 60 minutes postdose|Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC0-60 data.|||nanomole*minute per liter (nmol*min/L)||Standard Deviation|Mean
1460451|NCT00774787|Other Pre-specified|Local Skin Reactions|Mean maximum post-baseline intensity of investigator assessed local skin reactions (erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, erosion/ulceration) by treatment area. 0 = none, 1 = mild, 2 = moderate, 3 = severe. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|Post baseline to end of study (4-8 weeks post-treatment)|One patient not included who was lost to follow-up immediately after baseline visit, and had no post-treatment data.|||Scores on a scale||Standard Deviation|Mean
1460452|NCT00774787|Secondary|Cosmetic Appearance Score at 4-8 Weeks Post-treatment|Cosmetic appearance score, based recall comparison to appearance at baseline. Seven point scale: +3 = treatment area is much better appearing; +2 = treatment area is moderately better appearing; + 1 = treatment area is slightly better appearing; 0 = treatment area appears same; -1 = treatment area is slightly worse appearing; -2 = treatment area is moderately worse appearing; -3 = treatment area is much worse appearing. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses.|4-8 weeks post-treatment|Patients who had end of study visit with cosmetic appearance assessment. Cosmetic appearance score, by treatment area, not included for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data.|||Scores on a scale||Standard Deviation|Mean
1460454|NCT00774787|Primary|Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment|Percent change = [(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)]/(actinic keratoses count at baseline)]*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.|Baseline, 4-8 weeks post-treatment|Patients who had end of study visit with count of actinic keratoses. Change not calculated for one patient who was lost to follow-up immediately after baseline visit, and had no post-treatment data. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline or new.|||Percent change||Standard Deviation|Mean
1460455|NCT00774748|Secondary|Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)|GFR was calculated from a creatinine blood level to establish a safe renal function that would validate anti-Xa levels. Low molecular weight heparin is primarily cleared from the body by the kidneys. Any condition that decreases kidney function can potentially decrease LMWH clearance, increasing its concentration in the blood and increasing the potential for excessive bleeding.|6 time points in approximately 3 months|Included all participants who had at lease one visit and one blood draw.|||mL/min||Full Range|Mean
1460456|NCT00774748|Primary|Average Subcutaneous Anti-Xa Blood Levels|Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.|approximately 3 months|Participants were separated into the two dosing schedules, since the target anti-Xa level is different for the two different types of doses. The once daily dosing sub-group was analyzed for this primary outcome measure.|||IU/mL||Full Range|Mean
1460457|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7|Comparing anti-Xa levels from the first day of using the port and the last day of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|7 days|All participants, excluding two outliers of 97% and 150%|||Percent||Full Range|Median
1460458|NCT00774748|Secondary|Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port|Comparing subcutaneous baseline (without port) anti-Xa levels with day one of using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|approximately 3 months|Twenty participants, excluding one outlier of 97%.|||Percent||Full Range|Median
1460459|NCT00774748|Secondary|Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels|Anti-Xa subcutaneous blood levels are displayed in percent difference to show normal fluctuations of anti-Xa levels without using the port. A percent difference is calculated by the current value has the previous value subtracted from it; this new number is divided by the absolute value of the previous value; then this new number is multiplied by 100. This allows each set of data to be compared to itself. Anti-Xa tests measure the concentration of low molecular weight heparin in the blood.|6 time points (for each participant) in approximately 3 months|All participants were represented with a baseline fluctuation in percent difference.|||Percent||Full Range|Median
1460460|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of PegIFN at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1460461|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1460462|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV)|C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1460463|NCT00774397|Secondary|Trough Concentration (Cpre,ss) of Faldaprevir at Steady State|C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose.|Week 8, week 10, week 12, week 24|All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1460464|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline Total Bilirubin)|||percentage of patients|||Number
1460465|NCT00774397|Secondary|Change From Baseline to Week 24 in Total Bilirubin of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Total Bilirubin at Week 24)|||mg/dL||Standard Deviation|Mean
1460466|NCT00774397|Secondary|Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT|Number of patients with normal or low baseline moved to high .|Baseline and Week 24|Treated Set (for patients with normal or low baseline ALT/GPT,SGPT)|||percentage of patients|||Number
1477231|NCT00651625|Secondary|Aspirated Fluid Volume|Aspirated fluid volume during procedure|during procedure||||ml||Standard Deviation|Mean
1460472|NCT00774397|Secondary|Global Assessment of Tolerability|"The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation.~Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'."|Week 24|Per protocol set|||percentage of patients|||Number
1460473|NCT00774397|Secondary|Change From Baseline to Week 24 in Weight of the Patients|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Weight at Week 24)|||kg||Standard Deviation|Mean
1460474|NCT00774397|Secondary|Change From Baseline to Week 24 in Pulse Rate|Baseline is defined as the last value before the administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Pulse rate at Week 24)|||bpm||Standard Deviation|Mean
1460475|NCT00774397|Secondary|Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure|Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo.|Baseline and Week 24|Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24)|||mmHg||Standard Deviation|Mean
1460476|NCT00774397|Secondary|Relapse|"Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection.~Patients could experience relapse at any point post-treatment."|post-End of treatment (i.e. post 48 weeks)|Per protocol set|||percentage of patients|||Number
1460477|NCT00774397|Secondary|Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing)|Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout.|Week 24 through Week 48|Per protocol set|||percentage of patients|||Number
1460478|NCT00774397|Secondary|Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing)|Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout.|Up to Week 24|Per protocol set|||percentage of patients|||Number
1460479|NCT00774397|Secondary|Virological Rebound|"Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection.~Note that this is numerical rebound, not requiring confirmation with a re-measurement."|Week 24 or Week 48|Per protocol set|||percentage of patients|||Number
1460480|NCT00774397|Secondary|Time to Loss of Virological Response|"Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero.~Time is expressed in Median number of days."|Week 24|Per protocol set|||Number of days||95% Confidence Interval|Median
1460481|NCT00774397|Secondary|Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection|Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD)|On or after day 155 post end of all treatment|Per protocol set|||Days||Full Range|Median
1460482|NCT00774397|Secondary|Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy|Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60|Week 36 or Week 60|Per protocol set|||percentage of patients|||Number
1460483|NCT00774397|Secondary|End of Treatment Response at End of All Therapy|End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48|Week 24 or Week 48|Per protocol set|||percentage of patients|||Number
1460484|NCT00774397|Secondary|End of Treatment Response at Week 24|End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24.|Week 24|Per protocol set|||percentage of patients|||Number
1460485|NCT00774397|Secondary|Complete Early Virological Response (cEVR)|Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12|Week 12|Per protocol set|||percentage of patients|||Number
1460486|NCT00774397|Secondary|Extended Rapid Virological Response (eRVR)|Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12|Week 4 and Week 12|Per protocol set|||percentage of patients|||Number
1460487|NCT00774397|Secondary|Early Virological Response (EVR)|Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12|Baseline and Week 12|Per protocol set|||percentage of patients|||Number
1460488|NCT00774397|Secondary|Virological Response at Week 4|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)|Week 4|Per protocol set|||percentage of patients|||Number
1460489|NCT00774397|Secondary|Virological Response at Week 2|Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable)|Week 2|Per protocol set|||percentage of patients|||Number
1460490|NCT00774397|Primary|Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy|"Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection.~The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24.~Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved."|Day 155 after the end of all treatment|Per protocol set|||percentage of patients||95% Confidence Interval|Number
1460651|NCT00773513|Secondary|Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
1506266|NCT00425269|Secondary|C-peptide, 0-h, Baseline||baseline||||pmol/L||95% Confidence Interval|Mean
1460491|NCT00774397|Primary|Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo|"An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD).~This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48.~The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'."|Week 28|"Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations .~FAS was composed of all randomised patients who took at least 1 dose of study medication.~For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated."|||percentage of patients|||Number
1460492|NCT00774306|Secondary|Incidence of Acute Seizures, Incidence of Late Seizures, Overall Neurologic Function (as Measured by Modified Rankin Scale Scores)||8 weeks, 16 weeks|||||||
1460493|NCT00774306|Primary|Change in Serum Cholesterol, Non-HDL Cholesterol, HDL Cholesterol, Lipoprotein(a), and C-reactive Protein From Baseline to Second Draw and Third Draw in Each of the 4 Study Arms||8 weeks, 16 weeks|||||||
1460494|NCT00774267|Primary|Percent Change From Baseline in Mammographic Breast Density at Month 24|The digitized mammogram pairs were analyzed by a single trained radiologist who determined the density of the breast using software. The only left craniocaudal view was used for assessing breast density.|primary study baseline, Month 24|All available participants were analyzed. Here, ‘N’ (number of participants analyzed) signifies those participants who had technically acceptable mammograms available at primary study baseline and Month 24.|||percent change||Standard Deviation|Mean
1460495|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1460496|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1460497|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1460498|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1460499|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1460500|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|days of observation||Number
1460501|NCT00774163|Primary|Serum Creatinine||Day 5||||mg/dl||Standard Deviation|Mean
1460502|NCT00774163|Primary|Blood Urea Nitrogen||Day 5||||mg/dl||Standard Deviation|Mean
1460503|NCT00774163|Primary|Serum AST in Males||Day 5|limited to males|||units per liter (U/L)||Standard Deviation|Mean
1460504|NCT00774163|Primary|Serum Aspartate Aminotransferase (AST) in Females||Day 5|limited to females|||units per liter (U/L)||Standard Deviation|Mean
1460505|NCT00774163|Primary|Serum ALT in Males||Day 5|limited to males|||units per liter (U/L)||Standard Deviation|Mean
1460506|NCT00774163|Primary|Serum Alanine Aminotransferase (ALT) in Female Participants||Day 5|limited to females|||units per liter (U/L)||Standard Deviation|Mean
1460507|NCT00774163|Primary|Leukocyte Count on Day 5||Measured on day 5||||cells per cubic millimeter||Standard Deviation|Mean
1460508|NCT00774163|Primary|Mean Daily Temperature|Measured daily during 5 days of study product administration|5 days of study product administration||||Degrees Celcius||Standard Deviation|Mean
1460509|NCT00774163|Secondary|Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported||Day 0 through 6 weeks after Day 0||||days with symptom reported|Days of observation||Number
1460510|NCT00774163|Secondary|Number of Subjects With at Least One PCR Positive Stool Specimen||Average of 36 day follow up period||||participants|||Number
1460511|NCT00774163|Primary|Number of Participants With a Positive Blood Culture for L. Reuteri|To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).|participants were followed for an average of 36 days|2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol|||participants|||Number
1460512|NCT00774046|Secondary|Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 883 days|Subset of patients undergoing autologous stem cell transplant|||Days||Full Range|Median
1460513|NCT00774046|Secondary|Overall Survival in Patients Undergoing Autologous Stem Cell Transplant||Up to 817 days|Subset of patients undergoing autologous stem cell transplant|||Days||Full Range|Median
1460514|NCT00774046|Secondary|Numbers of Stem Cells Collected||1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.|||10^6 CD34+ cells/kg||Full Range|Median
1460515|NCT00774046|Secondary|Feasibility of Stem Cell Collection|Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg|1-5 days from initiation of stem cell collection|Subset of patients in CR who underwent mobilization and attempted stem cell collection.|||percentage of participants||95% Confidence Interval|Number
1460516|NCT00774046|Primary|Relapse-free Survival|Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.|Up to 2000 days||||Days||Inter-Quartile Range|Median
1460517|NCT00774046|Primary|Overall Survival||Up to 2000 days||||Days||Inter-Quartile Range|Median
1460727|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Age.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1460518|NCT00774046|Primary|Response to Induction Chemotherapy (CR or PR)|Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made|Day 28-40||||percentage of participants||95% Confidence Interval|Number
1460519|NCT00773968|Secondary|Percentage of Participants Who Required Red Blood Cell Transfusions||Weeks 1 to 28|Safety population.|||percentage of participants|||Number
1460520|NCT00773968|Secondary|Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP|The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was >1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.|DTP: Weeks 1 to 16; EEP: Weeks 17 to 28|Per protocol population.|||percentage of participants|||Number
1460521|NCT00773968|Secondary|Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP||EEP: Weeks 17 to 28|Per protocol population.|||days||Full Range|Median
1460522|NCT00773968|Secondary|Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP||EEP: Weeks 17 to 28|Per protocol population.|||percentage of participants||95% Confidence Interval|Number
1460523|NCT00773968|Secondary|Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)|Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.|SVP: Week -4 to Week 0; EEP: Weeks 17 to 28|Per protocol population.|||g/dL||Standard Deviation|Mean
1460524|NCT00773968|Primary|Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)|The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).|EEP: Weeks 17 to 28|Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation.|||percentage of participants||95% Confidence Interval|Number
1460525|NCT00773955|Secondary|Duration of Response||From the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years|There were no confirmed responses qualifying for this endpoint.||||||
1460526|NCT00773955|Secondary|Time to Disease Progression|"Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. Estimated using the method of Kaplan-Meier.~Per the RECIST criteria, progression is defined as at least a 20% increase in the sum of Longest Dimension (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|From registration to the earliest date documentation of disease progression, assessed up to 5 years|All 15 patients were analyzed for this endpoint.|||months||95% Confidence Interval|Median
1460527|NCT00773955|Secondary|Survival Time|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years|All 15 patients were analyzed for this endpoint.|||months||95% Confidence Interval|Median
1460528|NCT00773955|Primary|Number of Participants With Confirmed Tumor Response Defined to be Either a Complete Response (CR) or Partial Response (PR)|"The number of successes will be estimated by counting the number of participants with confirmed responses. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:~A Complete Response (CR) requires the disappearance of all target lesions~A Partial Response (PR) requires a >=30% decrease in the sum of the longest diameter of target lesions from baseline measurements."|During the first 6 courses of treatment|One patient discontinued therapy after one cycle of treatment due to persistent grade 1 thrombocytopenia. Therefore, fourteen patients were evaluable for the primary end point at the interim analysis.|||participants|||Number
1460529|NCT00773786|Secondary|Change From Baseline in Inspiratory Capacity at 1 Week|Change from baseline in Inspiratory Capacity (IC) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline).|baseline and 2 hours after dosing||||Liters||Standard Error|Mean
1460530|NCT00773786|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at 1 Week|Change from baseline in Forced Vital Capacity (FVC) after 1 week on Brovana or Placebo. (Change = 1 week - baseline)|baseline and 1 week||||Liters||Standard Error|Mean
1460531|NCT00773786|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 1 Week|Change from baseline in Forced Expiratory Volume in 1 second (FEV1) after 1 week on Brovana or Placebo (measured 2 hours post dose). (Change = 1 week - baseline)|baseline and 1 week||||Liters||Standard Error|Mean
1460545|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 36|Intent to Treat; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
1460532|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460533|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460534|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 24|ITT; Participants who entered the extension period|||percentage of participants||95% Confidence Interval|Number
1460535|NCT00773734|Other Pre-specified|LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460536|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1460537|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1460546|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 24|Intent to Treat; Includes participants who entered the long term extension study|||units on a scale||Standard Deviation|Mean
1506267|NCT00425269|Secondary|HbA1c, Baseline||baseline||||percent of Hb||95% Confidence Interval|Mean
1460538|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1460539|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long-term extension study|||units on a scale||Standard Deviation|Mean
1460540|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 48|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1460541|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 36|ITT; Includes participants who entered the long-term extension study|||units on a scale||Standard Deviation|Mean
1460542|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 24|ITT; Includes participants who entered the long-term extension period|||units on a scale||Standard Deviation|Mean
1460543|NCT00773734|Secondary|LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Month 18|ITT; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
1460544|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 48|Intent to Treat; Includes participants who entered the long term extension study|||units on a scale||Standard Deviation|Mean
1460547|NCT00773734|Secondary|LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Month 18|Intent to Treat; Includes participants who entered the long term extension period|||units on a scale||Standard Deviation|Mean
1460548|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
1460549|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|Intent to Treat; participants who entered into the long-term extension period|||percent change||Full Range|Median
1460550|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
1460551|NCT00773734|Secondary|LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; participants who entered into the LTE period|||percent change||Full Range|Median
1460552|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 48|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1460553|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 36|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1460554|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 24|ITT; participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1460555|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Month 18|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
1460556|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 196|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.||||||
1460557|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 4 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1460652|NCT00773513|Secondary|Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
1460558|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 3 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1460559|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 2 Years|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1460560|NCT00773734|Secondary|LTE Study: Percent Change From Baseline in PASI Score at 18 Months|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percent change||Standard Deviation|Mean
1460561|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years|PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1460562|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460563|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460564|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1474322|NCT00674466|Primary|Reduction of HbA1c From Baseline|Change from baseline|Screening and Day 85|Modified Intent-to-Treat Population|||Percent (%)||Standard Deviation|Mean
1460565|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460566|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460567|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460568|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460569|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460570|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 48|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1460571|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 36|ITT; Participants who entered the long-term extension period|||percentage of participants||95% Confidence Interval|Number
1465556|NCT00736099|Secondary|Number of Patients With Lowered HbA1c by at Least 0.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||participants|||Number
1460572|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 24|ITT; participants who entered the long-term extension study|||percentage of participants||95% Confidence Interval|Number
1460573|NCT00773734|Secondary|LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Month 18|ITT; participants who entered the long-term extension study|||percentage of participants||95% Confidence Interval|Number
1460574|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks|Safety population: includes all participants who were treated with Apremilast|||participants|||Number
1460575|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase|For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI-90 was not defined or analyzed as there were too few such participants.||||||
1460576|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase|For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.|Weeks 0 to 16|Includes PASI-75 responders during the placebo controlled phase.|||weeks||Full Range|Median
1460577|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase|For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to 16|Includes PASI-50 responders during the placebo controlled phase|||weeks||Full Range|Median
1460578|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0-88; up to data cut off of 21 July 2011|Includes all participants who were treated with Apremilast|||participants|||Number
1460579|NCT00773734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Week 0 to Week 16; up to data cut off of 21 July 2011|Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)|||participants|||Number
1461843|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1460580|NCT00773734|Secondary|Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)|Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.|Up to 4 weeks after the last dose|Participants who entered the observational follow-up phase and were PASI-50 responders at the beginning of the time interval.|||weeks||95% Confidence Interval|Median
1460581|NCT00773734|Secondary|Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.|Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study|Week 0 to 52|This endpoint was not summarized since the time of the maximal improvement is variable and the maximal improvement could occur in either the core phase or the extension phase||||||
1460582|NCT00773734|Secondary|Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52|Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0|Week 0 to Week 52|The dose-response relationship analysis was anticipated, however, since the extension study was optional and there was not placebo control, no formal testing of dose response was conducted||||||
1460583|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value..|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460584|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 52|Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat;|||units on a scale||Standard Deviation|Mean
1460585|NCT00773734|Secondary|Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460586|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 40|Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460641|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1460587|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460588|NCT00773734|Secondary|Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 32|Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460589|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 52|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460590|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 40|Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460591|NCT00773734|Secondary|Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 32|Includes participants who entered the extension study and had DLQI assessment at Week 32; Intent to Treat|||units on a scale||Standard Deviation|Mean
1460592|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 52|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 52|Includes participants who entered the extension study and had BSA assessment at Week 52; Intent to Treat;|||percent change||Standard Deviation|Mean
1460593|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 40|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 40|Includes participants who entered the extension study and had BSA assessment at Week 40; Intent to Treat|||percent change||Standard Deviation|Mean
1460594|NCT00773734|Secondary|Extension Study: Percent Change From Baseline in the Affected BSA at Week 32|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 32|Includes participants who entered the extension study and had a BSA assessment at Week 32; Intent to Treat|||percent change||Standard Deviation|Mean
1460595|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 52|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
1483251|NCT00602225|Secondary|Hematologic and Non-hematologic Side Effect Profile||45 days after the last dose of clofarabine|Data not collected||||||
1460596|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 40|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
1460597|NCT00773734|Secondary|Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 32|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.||||||
1460598|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 52|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 52|Includes participants who entered the extension study and had PASI assessment at Week 52; Intent to Treat;|||percent change||Standard Deviation|Mean
1460599|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 40|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 40|Includes participants who entered the extension study and had PASI assessment at Week 40; Intent to Treat;|||percent change||Standard Deviation|Mean
1460600|NCT00773734|Secondary|Extension Study: Percent Change in PASI Score at Week 32|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 32|Includes participants who entered the extension study and had PASI assessment at Week 32; Intent to Treat|||percent change||Standard Deviation|Mean
1460601|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1460653|NCT00773513|Secondary|Time to Non-Fatal and Fatal Stroke||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
1460654|NCT00773513|Secondary|Time to Non-Fatal and Fatal Myocardial Infarction||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.|||years||95% Confidence Interval|Median
1460602|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat|||percentage of participants||95% Confidence Interval|Number
1460603|NCT00773734|Other Pre-specified|Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat|||percentage of participants||95% Confidence Interval|Number
1460604|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-100 During the Extension Study|For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.|Week 0 to Extension Study|Time to achieve PASI-100 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1460605|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-90 During the Extension Study|For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.|Week 0 to Extension study|Time to achieve PASI-90 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1460606|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-50 During the Extension Study|For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.|Week 0 to Week 52|Time to achieve PASI-50 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1460607|NCT00773734|Secondary|Extension Study: Time to Achieve PASI-75 During the Extension Study|For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.|Week 0 to Week 52|Time to achieve PASI-75 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study||||||
1460608|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1460609|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1460610|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1461844|NCT00764881|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1460611|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460612|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460613|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460614|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460615|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460616|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460655|NCT00773513|Secondary|Time to All-Cause Mortality||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.|||years||95% Confidence Interval|Median
1460728|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Gender.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1460617|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 40|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460618|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 32|Includes participants who entered the extension study; Intent to Treat; Non-responder imputation|||percentage of participants||95% Confidence Interval|Number
1460619|NCT00773734|Secondary|Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 52|Includes participants who entered the extension study; LOCF was used.|||percentage of participants||95% Confidence Interval|Number
1460620|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||hours||Full Range|Median
1460621|NCT00773734|Secondary|Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)|Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||hours||Full Range|Median
1460622|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1460623|NCT00773734|Secondary|Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast|The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1460624|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.|Week 24|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1460625|NCT00773734|Secondary|Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)|Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.|Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast|Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1460626|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
1460656|NCT00773513|Primary|Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.|||years||95% Confidence Interval|Median
1460627|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
1460628|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
1460629|NCT00773734|Secondary|Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16|The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations–physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations–emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value − baseline value.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
1460630|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||units on a scale||Standard Deviation|Mean
1460631|NCT00773734|Secondary|Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects’ quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||units on a scale||Standard Error|Least Squares Mean
1460632|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
1460633|NCT00773734|Secondary|Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase|The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant’s hand (entire palmar surface or “handprint”), which equates to approximately 1% of total BSA.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percent change||Standard Error|Least Squares Mean
1460642|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16|A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The PASI 100 was not defined and analyzed since there were too few such participants.||||||
1460634|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 24|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.||||||
1460635|NCT00773734|Secondary|Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16|Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).|Week 0 to Week 16|The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See other pre-specified outcome measures.||||||
1460636|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 and Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1460637|NCT00773734|Other Pre-specified|Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16|The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease|Week 0 to Week 16|Intent to Treat; Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1460638|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 24|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percent change||Standard Deviation|Mean
1460639|NCT00773734|Secondary|Core Study: Percent Change From Baseline in PASI Score at Week 16|The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||Percent change||Standard Error|Least Squares Mean
1460640|NCT00773734|Secondary|Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase|For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.|Weeks 0 to 16|Time to achieve PASI 100 was not defined or analyzed as there were too few participants.||||||
1460657|NCT00773474|Secondary|Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).||18 months|20 evaluable subjects were analyzed for Clinical Benefit Rate (CR+PR+SD>180 days per RECIST criteria.|||participants|||Number
1460643|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1460644|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16|PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1460645|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1460646|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1460647|NCT00773734|Secondary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 to Week 24|Intent to Treat; Placebo participants re-randomized at Week 16; End of Period = Last observation carried forward in the period|||percentage of participants||95% Confidence Interval|Number
1460648|NCT00773734|Primary|Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).|Week 0 and Week 16|The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values|||percentage of participants|||Number
1460649|NCT00773513|Secondary|Percentage of Participants With Thromboembolic Events||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
1460650|NCT00773513|Secondary|Percentage of Participants With Gastrointestinal Bleeding||Baseline up to approximately 8.5 years|The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.|||percentage of participants|||Number
1460663|NCT00773461|Secondary|Percentage of Participants With ACR20 Response by First Week of Onset|ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator.|Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||Percentage of Participants|||Number
1460664|NCT00773461|Secondary|Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24|HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and 24 Weeks|ITT Population|||units on a scale||Standard Deviation|Mean
1460665|NCT00773461|Secondary|Change in Hemoglobin From Baseline to Week 24|Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants|Baseline and 24 Weeks|ITT Population|||g/L||Standard Deviation|Mean
1460666|NCT00773461|Secondary|Mean Rheumatoid Factor at Baseline and Week 24|Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL.|Baseline and 24 Weeks|ITT Population|||IU/mL||Standard Deviation|Mean
1460667|NCT00773461|Secondary|Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in health status.|Baseline and Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1460668|NCT00773461|Secondary|Percentage of Participants With Low Disease Activity and in Clinical Remission|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; n=number of participants analyzed.|||Percentage of Participants|||Number
1460669|NCT00773461|Secondary|Change in ESR From Baseline to Week 24|The ESR was measured in mm/hour. A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population|||mm/hour||Standard Deviation|Mean
1460670|NCT00773461|Secondary|Change in C-Reactive Protein From Baseline to Week 24|The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline and Week 24|ITT Population|||mg/dL||Standard Deviation|Mean
1460671|NCT00773461|Secondary|Change in Participant's Global Assessment of Pain From Baseline to Week 24|The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
1460672|NCT00773461|Secondary|Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity).|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
1460673|NCT00773461|Secondary|Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24|The participant’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline and Week 24|ITT Population|||mm||Standard Deviation|Mean
1460674|NCT00773461|Secondary|Change in Tender and Swollen Joint Counts From Baseline to Week 24|"68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.~66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66."|Baseline and Week 24|ITT Population|||Joints||Standard Deviation|Mean
1460675|NCT00773461|Secondary|Number of Participants Who Received Escape Therapy|Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD.|24 Weeks|ITT Population|||Number of participants|||Number
1460676|NCT00773461|Secondary|Percentage of Participants With ACR50 and ACR70 Responses at Week 24|To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted.|Week 24|ITT Population|||Percentage of Participants|||Number
1460784|NCT00772538|Secondary|Number of Patients With at Least One Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1460785|NCT00772538|Secondary|Number of Hospitalisations for Asthma Exacerbations Per Patient During the 48-week Treatment Period.||48 weeks|All patients from FAS.|||Participants|||Number
1460677|NCT00773461|Primary|Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24|To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician’s global assessment of disease activity, participant’s global assessment of disease activity, participant’s assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward [LOCF]).|Week 24|ITT Population|||Percentage of Participants|||Number
1460678|NCT00773422|Secondary|Number of Cigarettes Smoked During the Ad-lib Period|Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study.|day 8||||cigarettes||Standard Error|Mean
1460679|NCT00773422|Primary|Latency to Initiate Ad-lib Smoking Session|Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes.|day 8||||minutes||Standard Error|Mean
1460680|NCT00773383|Secondary|Assessment of Potential Predictive and Prognostic Biomarkers.|Total IGF-I, free IGF I/II and other potential biomarkers present in serum. Further putative biomarker analyses in blood and tumor samples were planned in the protocol for exploratory assessment of correlation with clinical outcome. None of these were analyzed due to the termination of the trial.|Throughout study|Responders and non-responders||||||
1460681|NCT00773383|Secondary|Population Pharmacokinetics of R1507 and Tarceva|Population PK of R1507 and erlotinib were planned but not analyzed due to the termination of the trial.|Throughout study|Population PK of R1507 and erlotinib||||||
1460682|NCT00773383|Secondary|Electrocardiogram (ECG)|12 lead ECG is required at baseline and will be measured during the trial as clinically indicated at the discretion of the investigators. For each reading, QTcF value will be calculated as the QT value (seconds) divided by the cube root of the RR interval in seconds (Fridericia correction). A listing will be generated showing, for each patient, the visits at which ECGs were taken and the results (normal or abnormal, as well as any comments provided).|baseline and thereafter as clinically indicated at the discretion of the investigator up to the time that the patient discontinued (up to 59 weeks)|Safety Population|||ms (millisecond)||Standard Deviation|Mean
1460683|NCT00773383|Secondary|Number of Participants With Positive Results for Human Anti-human Antibody (HAHA) Testing|"Number of participants who tested positive for Human anti-human antibody (HAHA) testing for immunogenicity.~To determine HAHA specificity, screened positive samples were tested in a confirmatory assay in the presence of 10 ug/mL R1507. Samples with > 19.7% inhibition were considered true positives, whereas those with < 19.7% inhibition were considered to be false positives."|prior to dosing on week 1 (day 1), week 4 (day 22), week 10 (day 64), final visit, follow up visit and 12 weeks post last dose (up to 71 weeks)|Safety Population|||participants|||Number
1460684|NCT00773383|Secondary|Monthly Urine Pregnancy Test in Female Patients of Childbearing Potential|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Not posted; it will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|Within 7 days of starting treatment (baseline visit)|Female patients of childbearing potential||||||
1460685|NCT00773383|Secondary|Hemoglobin A1c (HbA1c)|"Standard safety monitoring includes baseline Electrocardiogram (ECG), Fasting glucose and HbA1c, monthly urine pregnancy test in female patients of childbearing potential and Human anti-human antibody (HAHA) testing.~Data will be represented in the Serious Adverse Event (SAE) Adverse Event (AE) section of Protocol Registration System (PRS)."|screening|Safety Population||||||
1460686|NCT00773383|Secondary|Fasting Glucose, Highest Post-Baseline Value|A fasting glucose was required at baseline, and random non-fasting glucose testing was performed weekly for the first 6 weeks followed by day 1 of each 3 week treatment phase. The number of participants with the highest post-baseline fasting glucose level at any time point post baseline relative to the participant’s baseline glucose level is reported.|Baseline, Highest Post-Baseline value within the timeframe of post-baseline collection up to when patient discontinued (up to 59 weeks)|Safety Population: based on the total number of participants n = 34|||participants|||Number
1460687|NCT00773383|Secondary|Baseline Electrocardiogram (ECG)|"Standard safety monitoring includes baseline Electrocardiogram (ECG).~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|baseline within 28 days of starting treatment (screening visit).|Safety Population||||||
1460688|NCT00773383|Secondary|Duration of Objective Response|This is defined similarly for complete and partial responders. Complete response or partial response lasts from the date the complete response or partial response was first recorded to the date on which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken. The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|from the date the complete or partial response was first recorded to the date which progressive disease is first noted or date of death. If a patient does not progress or die while being followed, the date of the last valid tumor assessment will be taken|All Treated Population||||||
1460689|NCT00773383|Secondary|Time to Progressive Disease (PD)|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of therapy to the date of first documentation of PD. Pts who never progress prior to final analysis or are withdrawn from the study without documented progression will be censored at the date of the last valid tumor assessment.|All Treated Population||||||
1460690|NCT00773383|Secondary|Time to Best Response|"This is defined as time from the start of therapy to the date of first CR or PR.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population||||||
1460691|NCT00773383|Secondary|Participants Achieving Objective Response|"Objective response is defined as a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST)criteria.~The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed."|Patients were followed from start of therapy until date of first response|All Treated Population||||||
1460692|NCT00773383|Secondary|Duration of Overall Survival|The study was prematurely terminated due to discontinuation of R1507 development (not for safety reasons). As a result, data not provided for outcome measures listed.|From start of treatment to death; up to the time that all participants ended treatment|All Treated Population||||||
1460693|NCT00773383|Primary|Percentage of Participants With Progression Free Survival (PFS)|The primary efficacy endpoint is progression-free survival at 12 weeks after start of therapy. A progression-free survival rate at 12 weeks will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 weeks.|12 weeks|All Treated Population|||Percentage of participants|||Number
1460694|NCT00773370|Secondary|Stroke Impact Scale (SIS)|The SIS Version 3.0 is a self report scale widely used to assess health status after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months|SIS data were incomplete for six sittercise participants, hence the discrepancy between number of participants analyzed and the flow data reported above.|||units on a scale||Standard Error|Mean
1460695|NCT00773370|Secondary|Short Physical Performance Battery (SPPB)|The SPPB, which is extensively used in stroke studies, includes three components and a composite score. Components include gait speed, a repeated chair stand, and a standing balance test. Scores for gait speed, chair stand, and total balance are calculated and then summed for the total score. Each component can range from 0-4 points, thus the maximum composite score can range from 0-12 points, with 0 reflecting the lowest functioning while a score of 12 indicates the subject reached the maximum measured competency in all three domains. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
1460696|NCT00773370|Secondary|Balance as Measured by the Berg Balance Scale (BBS)|The Berg is a widely used test for assessing balance and to predict fall risk in the elderly. It has been validated with patients post stroke. The Berg consists of 14 items, each graded on a scale of 0-4. Thus a score for the Berg could in theory range from a minimum of 0 to a maximum of 56. A score below 45 is indicative of balance impairment; thus the lower the score the greater the fall risk. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
1460697|NCT00773370|Primary|6 Minute Walk Test (6MWT)|Total distance walked for 6 minutes (in meters) is the primary outcome measure. Participants use the same assistive devices and/or orthoses they use when walking across a parking lot. They are instructed to cover as much distance as they can over a flat 100 foot walking surface demarcated by traffic cones during the six minute time period. Change in distance covered is the outcome variable of interest for this study. Walking a greater distance (e.g. more meters during the 6 minute test) reflects improvement in walking speed and endurance. We computed the slopes (i.e. rates of change from baseline to 3-months and 6-months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using unpaired Student's t-tests.|measured at baseline, 3 months, 6 months||||meters||Standard Error|Mean
1460698|NCT00773279|Secondary|Hypoglycaemic Episodes, Number of Events Per Subject Day||Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).|||events per subject-day|||Number
1460699|NCT00773279|Secondary|Number of Adverse Device Effects|Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.|From randomisation (week 0) and until 7 days after Week 24 (Visit 16)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||events|||Number
1460700|NCT00773279|Secondary|Number of Hypoglycaemic Episodes|Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.|Weeks 0-12 (first treatment) and 12-24 (second treatment)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||episodes|||Number
1460701|NCT00773279|Secondary|Clinical Technical Complaints (CTCs)|A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.|Weeks 0-24 (whole trial period)|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.|||CTCs|||Number
1465557|NCT00736099|Secondary|Number of Patients With HbA1c<6.5% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||participants|||Number
1460702|NCT00773279|Secondary|Score for Treatment Impact Measure for Diabetes|Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any TRIM-D available results in PDS290 and FlexPen® treatment groups, respectively.|||scores on a scale||Standard Deviation|Mean
1460703|NCT00773279|Secondary|Summary Score for Treatment Satisfaction|Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.|Week 24|ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available ITSQ results in PDS290 and FlexPen® treatment groups, respectively.|||scores on a scale||Standard Deviation|Mean
1460704|NCT00773279|Secondary|Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use|Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)|Week 24|ITT population. Some subjects did not have any available Niskanen Comparative Device Questionnaire results.|||percentage of participants|||Number
1460705|NCT00773279|Primary|HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®||Week 12 of each treatment sequence|Intention-to-treat (ITT) population comprising all randomised subjects and with data on HbA1c. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects dropped out during either treatment sequence.|||percentage (%) of total haemoglobin||Standard Deviation|Mean
1460706|NCT00773253|Primary|Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale|Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).|48 weeks|All participants that completed all phases of the study|||percent change in units on the scale||Standard Deviation|Mean
1460707|NCT00773253|Primary|Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)||pre-injection, week 16, 20, 36, and 40|||||||
1460708|NCT00773136|Primary|Efficacy of Bimatoprost in Lengthening of Eyelashes|Eyelash growth after application of bimatoprost vs control (split face study).|4.5 months (6 weeks of drug application and 3 months after discontinuing)||||mm||Standard Deviation|Mean
1460709|NCT00773097|Secondary|Number of Participants With Adverse Events Associated With the Study Agent|Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.|54 weeks||||participants|||Number
1460710|NCT00773097|Secondary|Number of Participants With Autoimmune Response to Muc-1 Vaccine|Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.|52 weeks||||participants|||Number
1460711|NCT00773097|Primary|Number of Participants With Anti Muc-1 Antibody|Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.|52 weeks|Of the 46 subjects who consented to participate, 6 did not receive vaccine: 4 had abnormal screening laboratory test, 1 did not meet criteria for an advanced adenoma, and 1 declined to participate|||participants|||Number
1460712|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1460713|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1460714|NCT00772967|Secondary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale.|Baseline and Day 1|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1465558|NCT00736099|Secondary|Number of Patients With HbA1c<7.0% Over Time||78 weeks|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||participants|||Number
1460715|NCT00772967|Primary|Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3|Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain – 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale.|Baseline and Day 3|All treated participants who provided baseline and at least one on-treatment observation|||units on a scale||95% Confidence Interval|Least Squares Mean
1460716|NCT00772954|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.||Day 0 up to 70 days post first vaccination|Safety assessments were on the safety population.|||Participants|||Number
1460717|NCT00772941|Secondary|Number of Participants With Continuous Abstinence Situation by 52 Weeks.|Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.|52 weeks|No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.|||participants|||Number
1460718|NCT00772941|Primary|Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of unlisted treatment related adverse events.|||events|||Number
1460719|NCT00772941|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.|24 weeks|No statistical analysis provided for the frequency of treatment related adverse events.|||participants|||Number
1460720|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.|||participants|||Number
1460721|NCT00772941|Primary|Risk Factors for the Proportion of Responders – Prolonged Administration After 12 Weeks.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.|||participants|||Number
1460722|NCT00772941|Primary|Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.|"The primary analysis item was the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants."|24 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.|||participants|||Number
1460723|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.|Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.|||participants|||Number
1460724|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Therapies.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1460725|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Drugs.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1460726|NCT00772941|Primary|Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.|Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.|24 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
1460729|NCT00772928|Other Pre-specified|Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™|Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.|0-3 days post- vaccination and entire study period|Analysis was on all enrolled and vaccinated subjects, intend-to-treat population.|||Percentage of Participants|||Number
1460730|NCT00772928|Primary|Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.|60 Days Post-dose 3|Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population|||All Units||95% Confidence Interval|Geometric Mean
1460731|NCT00772928|Primary|Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)|Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.|28 to 48 days post-3rd vaccination|Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population.|||Percentage of Participants|||Number
1460732|NCT00772915|Secondary|Adverse Events||Duration on treatment (up to 18 cycles from registration)|||||||
1460733|NCT00772915|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.~Progression was defined as any one or more of the following:An increase of 25% from lowest confirmed response in:~Serum M-component (absolute increase >= 0.5g/dl)~Urine M-component (absolute increase >= 200mg/24hour~Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl~Bone marrow plasma cell percentage (absolute increase of >=10%)"|Time from registration to progression or death (up to 3 years)|||||||
1460734|NCT00772915|Secondary|Overall Survival (OS)|OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 3 years from randomization. The median OS with 95% CI was estimated using the Kaplan Meier method|Time from registration to death (up to 3 years)|||||||
1460735|NCT00772915|Secondary|Overall Response Rate|"Response that was confirmed on 2 consecutive evaluations during treatment~Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM~Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels"|Up to 18 cycles from registration|||||||
1460736|NCT00772915|Primary|Progression-free Survival Rate at 12 Months|PFS at 12 months is a dichotomized outcome indicating whether or not a participant was progression free (and alive) at 12 months from the date of registration.|12 months from registration||||participants|||Number
1460737|NCT00772889|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 21-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1460738|NCT00772889|Secondary|HI Antibody Seroconversion Factors (SCF)|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available.|||fold increase||95% Confidence Interval|Mean
1460739|NCT00772889|Secondary|The Number of Subjects Seroconverted to HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
1460740|NCT00772889|Secondary|The Number of Subjects Seroprotected by HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
1460741|NCT00772889|Secondary|The Number of Subjects Seropositive to HI Antibodies|A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||Participants|||Count of Participants
1460742|NCT00772889|Secondary|Haemagglutination Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 0-21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||titer||95% Confidence Interval|Geometric Mean
1460819|NCT00772447|Primary|Change in Serum Total Creatine Phosphokinase (CPK)||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||IU/L||Standard Deviation|Mean
1460743|NCT00772889|Secondary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-364.|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1460744|NCT00772889|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1460745|NCT00772889|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1460746|NCT00772889|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1460747|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1460748|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1460749|NCT00772889|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1460750|NCT00772889|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1460751|NCT00772889|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1460752|NCT00772889|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was >20 mm for ecchymosis, redness and swelling.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1460753|NCT00772772|Secondary|1, 25-OH Vitamin D||after 8 weeks of vitamin D therapy|||||||
1460754|NCT00772772|Secondary|25-hydroxy Vitamin D (25-OH Vitamin D)|25-OH Vitamin D levels were measured in patients with chronic kidney disease at baseline and after 8 weeks of treatment with Vitamin D3 30000 units weekly.|after 8 weeks of vitamin D therapy|Patients with chronic kidney disease had 25-OH vitamin D levels measured at baseline and after 8 weeks of Vitamin D3 therapy. Analysis was per protocol.|||ng/ml||Standard Error|Mean
1460755|NCT00772772|Secondary|Nuclear Magnetic Resonance (NMR) Lipoprotein Profile||after 8 weeks of vitamin D therapy|||||||
1460756|NCT00772772|Secondary|Intestinal Permeability||after 8 weeks of vitamin D therapy|||||||
1460757|NCT00772772|Secondary|Blood Pressure||after 8 weeks of vitamin D therapy|||||||
1460758|NCT00772772|Primary|Change in Endotoxin Activity|Endotoxin Activity as measured by the Endotoxin Activity Assay. This measurement was made at baseline and after 8 weeks of therapy with Vitamin D3. The measurement of the assay is unitless. It is not based on an absolute amount of endotoxin, but rather the proportion of the theoretical maximal response of the patient and ranges from 0 (lowest) to 1 (highest).|baseline and 8 weeks|Per protocol. Result is expressed as change in endotoxin activity with therapy|||EA units||Standard Deviation|Mean
1460759|NCT00772707|Primary|Comfort Ratings at 30 Days|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|30 days|5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).|||Percentage of Participants|||Number
1460760|NCT00772707|Primary|Comfort Ratings at Baseline|"Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with Strongly Agree or Agree for each question is presented."|Baseline (Day 0)|6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).|||Percentage of Participants|||Number
1460761|NCT00772668|Secondary|Rate of Toxicity in Study Participants|Safety and tolerance to protocol therapy as evidenced by the rate of toxicity (serious adverse events and study-related adverse events) in study participants|Up to 5 years||||participants|||Number
1460762|NCT00772668|Secondary|Overall Survival (OS)|Overall survival (OS) will be measured as the time from date of enrollment to death from any cause. For patients who remain alive, survival time will be censored at the date of last contact.|Up to 5 years||||months|||Number
1460763|NCT00772668|Secondary|Progression-free Survival (PFS)|Progression free-survival will be assessed according to according to the International Workshop Criteria (IWC). Progression-free survival will be measured as the time from date of enrollment to relapse, progression or death due to follicular lymphoma (FL) or marginal zone lymphoma (MZL), whichever occurs first. Participants who do not experience relapse or progression, and those who die from causes other than cancer, will be censored at the date of last contact.|Up to 5 years||||months|||Number
1460764|NCT00772668|Primary|Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL)|"Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC):~Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL;~Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow;~Partial Response (PR) includes >= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen."|Post cycles 2,4,6,8 and then every 3 months, about 2 years|A minimum enrollment of 30 participants was required for this outcome measure. Due this minimum requirement not being met, and the early termination of the study due to lack of funding, the data for this outcome measure were not analyzed.||||||
1460765|NCT00772629|Primary|Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.|Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.|Day 28 post-vaccination|SBA-BR to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.|||Participants|||Number
1460766|NCT00772603|Secondary|Seizure Free Rate, ITT, (M)|Percent of patients seizure-free during Maintenance, Intent-to-Treat population|At the end of 12 weeks (Maintenance Period)|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.|||percentage of patients|||Number
1460767|NCT00772603|Secondary|Seizure-Free Rates, ITT|Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of patients|||Number
1460768|NCT00772603|Secondary|Responder Rate, ITT|Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population|At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of patients|||Number
1460769|NCT00772603|Secondary|PCH(M)- ITT|Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population|Change at 12 weeks (Maintenance Period) compared to Baseline|All safety population subjects with adequate baseline Seizure Diary data (at least three consecutive weeks) and at least one visit during the Titration Period and one visit during the Maintenance Period.|||percentage of change||95% Confidence Interval|Median
1460770|NCT00772603|Primary|PCH(T), ITT|Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population.|Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline|All safety population subjects with baseline Seizure Diary data and at least one visit during the Treatment Phase (ITT population). Subjects must have had at least 3 consecutive weeks of Seizure Diary data (SDD) in the Baseline Phase and at least 14 consecutive days of SDD after starting study drug.|||percentage of change||Full Range|Median
1460771|NCT00772590|Primary|Mean Change From Baseline CD4+ Cell Count|Comparison of normalised mean change from baseline CD4+ cell count|24 weeks|intention to treat (ITT) - all randomised patients who commenced randomly assigned therapy and who had at least one on-study visit.|||Cells/microlitre||Standard Deviation|Mean
1460772|NCT00772577|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (MSPP)|To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1460773|NCT00772577|Secondary|Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)|To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).|||Percentage of patients|||Number
1460774|NCT00772577|Secondary|Percentage of Patients Achieving Blood Pressure Control During 8 Weeks|The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.|8 weeks|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).|||Percentage of patients|||Number
1460775|NCT00772577|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)|To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1460776|NCT00772577|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)|To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).|Baseline to week 8|Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)|||mm Hg||Standard Deviation|Mean
1460777|NCT00772538|Post-Hoc|The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.417 (NCT00776984) and the Present 205.416 (NCT00772538)|"The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at 24-weeks and 48-weeks (on combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.~The ACQ total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment).~This outcome definition is taken from the primary outcome definition for the twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821) of the same development program."|24 weeks, 48 weeks|FAS of combined data from the two twin trials 205.416 (NCT00772538) and 205.417 (NCT00776984)|||percentage of participants|||Number
1460778|NCT00772538|Secondary|Mean Pro Re Nata (as Needed, PRN) Rescue Medication Use Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared. The response is defined as the change of the weekly mean from the baseline weekly mean. The use of PRN salbutamol (albuterol rescue medication) is determined by the number of puffs of rescue therapy used per day. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Puffs||Standard Error|Mean
1460779|NCT00772538|Secondary|Asthma Symptom Free Days Response During the Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The response is defined as the change of the weekly mean from the baseline weekly mean. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Days||Standard Error|Mean
1460780|NCT00772538|Secondary|ACQ at the End of the 48-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1460781|NCT00772538|Secondary|Asthma Control as Assessed by Asthma Control Questionnaire (ACQ) at the End of the 24-week Treatment Period.|For the ACQ, the total score was calculated as the mean of the responses to 7 questions and was analysed as an absolute value. The score ranges from 0 (no impairment) to 6 (maximum impairment). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1460782|NCT00772538|Secondary|AQLQ(S) Total Score at the End of the 48-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|48 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1460783|NCT00772538|Secondary|Quality of Life as Assessed by Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) at the End of the 24-week Treatment Period.|The AQLQ(S) total score was calculated as the mean of the responses to 32 questions for the domains Symptoms, Activity Limitations, Emotional Function and Environmental Stimuli and was analysed as an absolute value. The AQLQ(S) total score ranges from 1 (worst controlled) to 7 (best). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|24 weeks|All patients from FAS.|||Scores on a scale||Standard Error|Mean
1460786|NCT00772538|Secondary|Time to First Hospitalisation for Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS. As <50percent (10 of 222 patients in the placebo group and 8 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1460787|NCT00772538|Secondary|Number of Patients With at Least One Severe Asthma Exacerbation During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS.|||Participants|||Number
1460788|NCT00772538|Secondary|Number of Patients With at Least One Asthma Exacerbation During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS.|||Participants|||Number
1460789|NCT00772538|Secondary|Number of Severe Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS..|||Participants|||Number
1460790|NCT00772538|Secondary|Number of Asthma Exacerbations Per Patient During the 48-week Treatment Period.|Asthma exacerbations (including severe, non-severe; symptomatic, asymptomatic) were pre-defined as an episode of progressive increase in 1 or more asthma symptoms (e.g. shortness of breath, cough, wheezing, chest tightness or some combination of these symptoms). Additionally, decrease of patients best PEF a.m. of 30 percent or more from the patients mean PEF a.m. for at least 2 consecutive days was considered to be an objective marker of asthma exacerbation.|48 weeks|All patients from FAS..|||Participants|||Number
1460791|NCT00772538|Secondary|Time to First Severe Asthma Exacerbation During the 48-week Treatment.|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS. As <50percent (68 of 222 patients in the placebo group and 53 of 237 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.||||||
1460792|NCT00772538|Secondary|Mean PEF Variability Response (Absolute Difference Between Morning and Evening PEF Value Divided by Their Mean) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). The PEF variability is the absolute difference between morning and evening PEF value divided by their mean, expressed as a percent. Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Percent||Standard Error|Mean
1460793|NCT00772538|Secondary|Mean Pre-dose FEV1-p.m.Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1460794|NCT00772538|Secondary|Mean Pre-dose FEV1 a.m. Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||Liter||Standard Error|Mean
1460795|NCT00772538|Secondary|Mean Pre-dose Evening Peak Expiratory Flow (PEFp.m.) Response (Diary Data) of Last-7-days-before-week 24-visit.|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1460796|NCT00772538|Secondary|Mean Pre-dose Morning Peak Expiratory Flow (PEFa.m.) Response (Diary Data) of Last-7-days-before-week-24-visit .|Weekly means obtained during the last 7 days before week 24 visit were compared (measured by patients at home using the asthma monitor device). Response was defined as change from baseline. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and last 7 days before week 24 visit|All patients from FAS.|||L/min||Standard Error|Mean
1460797|NCT00772538|Secondary|FVC AUC0-3h Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460820|NCT00772447|Primary|Change in Creatinine Clearance||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||ml/min||Standard Deviation|Mean
1484426|NCT00592124|Secondary|Frequency of Male Condom Use||Measured through Week 21||||3-week periods|3-week periods||Count of Units
1460798|NCT00772538|Secondary|Trough FVC Response at the End of the 48-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 48 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460799|NCT00772538|Secondary|Peak FVC 0-3h Response at the End of the 48-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460800|NCT00772538|Secondary|AUC0-3h FEV1 Response at the End of the 48-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 48 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460801|NCT00772538|Secondary|Trough FEV1 Response at the End of the 48-week Treatment Period.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 48 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460802|NCT00772538|Secondary|Peak FEV1 0-3h Response at the End of the 48-week Treatment Period.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 48 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 48 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460803|NCT00772538|Secondary|FVC (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460804|NCT00772538|Secondary|FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 24-week Treatment Period.|The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 24 weeks. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460805|NCT00772538|Secondary|Trough FVC Response at the End of the 24-week Treatment Period.|The trough FVC is defined as the pre-dose FVC measured 10 minutes before the last administration of randomised treatment. Trough FVC response was defined as the difference between the trough FVC measured after a treatment period of 24 weeks and the FVC baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460806|NCT00772538|Secondary|Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 24-week Treatment Period.|Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460807|NCT00772538|Primary|Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984).|Severe asthma exacerbations were pre-defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days or (in case of ongoing and pre-existing systemic corticosteroid therapy) that required at least a doubling of the previous daily dose of systemic corticosteroids for at least 3 days.|48 weeks|All patients from FAS of the pooled twin studies 205.416 and 205.417. As <50percent (149 of 454 patients in the placebo group and 122 of 453 patients in the Tio R5 group) of patients had severe exacerbation, the median time was not calculable.|||Days||Inter-Quartile Range|Median
1460808|NCT00772538|Primary|Trough FEV1 Response Determined After a Treatment Period of 24 Weeks.|The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 24 weeks and the FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from FAS.|||Liter||Standard Error|Mean
1460809|NCT00772538|Primary|Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks.|Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 24 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.|Baseline and 24 weeks|All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who have baseline data and at least one on-treatment efficacy value.|||Liter||Standard Error|Mean
1461845|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1460810|NCT00772447|Secondary|Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC|This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 48 patients indentified staphylococcus aureus infection both in daptomycin group and in comparator group.|||Percentage of patients|||Number
1460811|NCT00772447|Secondary|Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC|This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.|baseline and TOC(test of cure), for up to 4 weeks|There were 33 patients indentified MSSA infection in daptomycin group and 37 patients indentified with MSSA in comparator group.|||Percentage of patients|||Number
1460812|NCT00772447|Secondary|Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)|This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.|baseline and TOC, for up to 4 weeks|There were 14 patients indentified MRSA infection in daptomycin group and 10 patients indentified with MRSA in comparator group.|||Percentage of patients|||Number
1460813|NCT00772447|Secondary|Microbiological Response at EOT(End of Therapy)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.|baseline and EOT, for up to 2 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 86 strains isolated from 81 patients in daptomycin arm and 88 strains from 81 patients in comparator arm who met the criteria of ME population at EOT visit.|||Percentage of strains|Participants||Number
1460814|NCT00772447|Secondary|Microbiological Response at TOC(Test of Cure)|The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.|baseline and TOC, for up to 4 weeks|ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. There were 83 strains isolated from ME population of daptomycin arm(78 patients) and 86 strains from ME population in comparator arm(79 patients).|||Percentage of strains|Participants||Number
1460815|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and EOT(end of therapy), for up to 2 weeks|There were 110 patients in daptomycin arm and 103 patients in comparator arm who both completed EOT visit and met the criteria of CE population|||Percentage of patients|||Number
1460816|NCT00772447|Secondary|Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)|The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)|baseline and TOC, for up to 4 weeks|There were 107 patients in daptomycin arm and 101 patients in comparator arm meeting the criteria of CE population and completed TOC visit.|||percentage of patients|||Number
1460817|NCT00772447|Primary|Shift in ECG|percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had both measurements at baseline and TOC visit and those who got normal ECG resluts at baseline were included in the summary. Change=TOC visit-baseline|||percentage of patients|||Number
1460818|NCT00772447|Primary|Change in Urine pH||baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements were included in the summary of a specific parameter at a specific time point. Change = TOC visit - baseline|||pH||Standard Deviation|Mean
1460821|NCT00772447|Primary|Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)|Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood|baseline to TOC(test of cure), for up to 4 weeks|Only patients who had measurements in both baseline and TOC visit were included for the analysis. Change=TOC visit-baseline|||percentage||Standard Deviation|Mean
1460822|NCT00772382|Secondary|The Change in Serum Phosphorus From Baseline to Week 52||52 weeks|Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.)|||mg/dL||95% Confidence Interval|Mean
1460823|NCT00772382|Primary|Number of Adverse Events (AE)||52 weeks||||participants|||Number
1460824|NCT00772369|Primary|Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.|"SAE: any untoward medical occurrence with the following outcomes:~death,~a life-threatening adverse drug experience (as confirmed by the investigators),~inpatient hospitalization or prolongation of existing hospitalization,~a persistent or significant disability/incapacity, or~a congenital anomaly/birth defect. Medical conditions that required 3 or more office or emergency room visits, and diagnosis by a physician of low blood cell count or low platelet count, swelling or redness of the joints, asthma, diabetes, or autism were also solicited. (MedDRA Version 6.0)"|6 Months post 4th dose vaccination|Response to questionnaire that were confirmed by the primary care physician’s office were analyzed, Primary Analysis Population. Unconfirmed safety data form 29 participants were excluded from the primary analysis.|||Participants|||Number
1460825|NCT00772369|Primary|Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series|"Positive response is a 'Yes' to any of the following questions:~Has your child been admitted to a hospital?~Has your child experienced an illness that made you fear for his/her life (life-threatening episode) that required attendance to the Emergency Room or a Physician’s office?~Has your child developed a medical condition that required 3 or more office or emergency room visits for that condition?~Has your child been diagnosed by a physician as having:~Low blood count or low platelet count? Swelling or redness of the joints? Asthma? Diabetes? Autism?"|6 months post 4th dose vaccination|Participants who completed the whole survey. Those who had confirmed data, or had data that did not require confirmation, or had unconfirmed data.|||Particpants|||Number
1460826|NCT00772304|Secondary|Taste and Aftertaste of Medication||5 min, 45 min.|||||||
1460827|NCT00772304|Primary|Product Preference Questionnaire for Immediate Taste|Using a set of coded responses, subjects evaluated product preference in regards to immediate taste|5 min post-dose||||Percentage of participants|||Number
1460828|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|14 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
1460829|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|7 days|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
1460830|NCT00772148|Primary|Percentage of Patients in Each Treatment Group Achieving Sufficient Tacrolimus Whole Blood Trough Levels (5 to 20 ng/mL) During the First 14 Days Post-transplantation.|Percentage of patients with trough levels within the therapeutic range of 5 to 20 ng/mL was assessed during the initial 14 days (on days 1, 7 and 14) after liver transplant and compared between the two treatment groups.|1 day|Percentage of patients achieving therapeutic tacrolimus trough levels on Day 1, Day 7 and Day 14.|||percentage of patients|||Number
1460831|NCT00772148|Primary|Pharmacokinetics (AUC0-24) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameter (AUC, 0 to 24 hours post dose) was evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)|||ng/mL*hr||Standard Deviation|Mean
1460832|NCT00772148|Secondary|Number of Participants Who Died Within the 360 Days.|Number of patients who died was compared between the two groups during the study.|360 days||||participants|||Number
1460833|NCT00772148|Primary|Pharmacokinetics (Cmax and Cmin) of LCP-Tacro™ Compared to Prograf Early After Transplantations (Within the First 14 Days) in Adult de Novo Liver Transplant Recipients.|The pharmacokinetic parameters (Cmax and Cmin) were evaluated during the first 14 days after liver transplant (on days 1, 7 and 14). The results for Day 14 is listed below as the primary outcome parameter for this study.|14 days|Arithmetic mean of the Pharmacokinetic parameters on Day 14 (mITT population)|||ng/mL||Standard Deviation|Mean
1460834|NCT00772109|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.|Day 0 up to 7 Days post vaccination|Safety analysis was on all enrolled and vaccinated participants, intend-to-treat population|||Participants|||Number
1460835|NCT00772109|Secondary|Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroprotection was defined as a HAI antibody titer ≥ 1:40."|Before and 28 Days post-vaccination|4-Fold increase in antibody levels were analyzed in h per-protocol population|||Percentage of Participants|||Number
1461846|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1460836|NCT00772109|Primary|Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine|"The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination."|28 Days post-vaccination|Seroprotection was analyzed in the per-protocol population|||Percentage of Participants|||Number
1460837|NCT00772109|Primary|Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines|The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay|Baseline (Day 0) and 28 Days post-vaccination|Geometric Mean Titers (GMTs) were analyzed in the per-protocol population|||Titer||95% Confidence Interval|Geometric Mean
1460838|NCT00772070|Primary|Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.||Day 0 and Days 8 and 28 post-vaccination|Geometric mean titers were determined in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1460839|NCT00772070|Other Pre-specified|Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.||Day 0 to 7 post-vaccination|Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.|||Percentage of participants|||Number
1460840|NCT00772070|Other Pre-specified|Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.||Baseline to Day 8 and Day 28 post-vaccination|Fold rise analysis was assessed in per-protocol population with valid serology data.|||Percentage of participants|||Number
1460841|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ) - Emotional Function at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 Months||||units on a scale||Standard Deviation|Mean
1460842|NCT00772031|Secondary|Change From Baseline in Migraine-Specific Quality of Life (MSQ)-Role Preventive at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
1460843|NCT00772031|Secondary|Change From Baseline in Migraine Specific Quality of Life (MSQ)-Role Restrictive Score at 6 Months|The MSQ (version 2.1 copyrighted 1992, 1996, 1998 by Glaxo Wellcome Inc., Research Triangle Park, North Carolina) is a 14 item questionnaire. Item responses are summed and scored as a total score and three domains: Role Preventive, Role Restrictive, Emotional Function. Scores within each domain are rescaled to range from 0 to 100. A lower score indicates a poorer quality of life associated with that domain or in total. Because of the observed interaction within a domain, only domain scores were used as outcome measures for this study.|baseline and 6 months post randomization|per protocol|||units on a scale||Standard Deviation|Mean
1460844|NCT00772031|Secondary|Change From Baseline in Migraine Disability Assessment (MIDAS) Score at 6 Months|MIDAS scoring ranges from 0 to 270. The scores are divided into ranges of disability with higher scores indicating increased disability as follows: 0-5 (Grade I - Minimal or infrequent disability); 6-10 (Grade II - Mild or infrequent disability); 11-20 (Grade III - Moderate disability); and 21+ (Grade IV - Severe disability).|Baseline and 6 months|per protocol|||units on a scale||Standard Deviation|Mean
1460845|NCT00772031|Secondary|Change From Baseline in Beck's Depression Inventory FastScreen Score at 6 Months|Total score from Beck's Depression Inventory FastScreen at 6 months minus total score from Beck's Depression Inventory FastScreen at baseline. Scale scores range from 0 to 21 with higher values indicating worsening depression. the following categories separate participants into groups of depression levels: Minimal (Score 0-3), Mild (Score 4-8),Moderate (Score 9-12),Severe (Score 13-21).|Baseline and 6 months|The number who completed the Beck's Depression Inventory at baseline and three months|||units on a scale||Standard Deviation|Mean
1460846|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 50% Reduction in 28-day Moderate to Severe Headache Days||6 months|All participants with the opportunity for 6-month follow-up. Due to early study termination some participants were randomized and did not have the opportunity to be followed for six months|||participants|||Number
1460847|NCT00772031|Secondary|Number of Subjects Experiencing at Least a 30% Reduction in 28-day Moderate to Severe Headache Days||6 months post randomization|All subjects randomized with opportunity for 6 month followup. Due to early study termination those who did not have opportunity for 6 month followup at time of study closure were excluded. All lost to followups were counted as failure|||participants|||Number
1460848|NCT00772031|Primary|Change in the Number of Moderate to Severe Headache Days Within a 28 Day Average Period in Six Months Compared to Baseline|(Number of moderate to severe headache days (as defined by the International Headache Society Guidelines (2006)) counted over a 28 day diary period at baseline (before treatment with propranolol or placebo)) minus (the number of moderate to severe headache days counted over a 56 day diary period (weeks 16-24 post treatment) divided by 2).|Baseline (pre-randomization), months 5 and 6 post randomization|ITT to the extent diary information was available. Available defined as all subjects with 12 or more diary entries between 16 and 24 weeks. Multiple imputation used on all randomized subjects as a sensitivity analysis on the primary outcome.|||Moderate to severe headache days||Standard Deviation|Mean
1461044|NCT00771810|Primary|Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3|Mean percentage of cycles with platelet counts below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
1474358|NCT00674297|Primary|Effects of Fluvastatin on Proinflammatory and Prothrombotic Biomarkers (BMR) in aPL Positive Patients|Biomarker sTF (pM)|3 months||||pM||Standard Deviation|Mean
1460849|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1460850|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460851|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Quality Rating|A sleep questionnaire was used to evaluate the effect of armodafinil on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in participants' ratings of their quality of sleep as measured on a 4-point scale (1=Poor, 2=Fair, 3=Good, 4=Excellent). A positive value represents improvement in sleep quality.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460852|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460853|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460854|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Asleep at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent asleep at night. A positive value indicates increased time spent asleep at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460855|NCT00772005|Secondary|Change From Baseline to Week 24 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460856|NCT00772005|Secondary|Change From Baseline to Week 12 in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460857|NCT00772005|Secondary|Change From Baseline to Endpoint in Time Spent Awake at Night|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported time spent awake at night. A positive value represents longer period awake at night.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1461045|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Bothersome|"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal."|Day 10|Intent-to Treat population.|||percent of participants|||Number
1460858|NCT00772005|Secondary|Change From Baseline to Week 24 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
1460859|NCT00772005|Secondary|Change From Baseline to Week 12 in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
1460860|NCT00772005|Secondary|Change From Baseline to Endpoint in Number of Nighttime Awakenings|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient's nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency, duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported number of nighttime awakenings. A positive value represents an increase in number of night time awakenings.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Awakenings||Standard Deviation|Mean
1460861|NCT00772005|Secondary|Change From Baseline to Week 24 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 24 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460862|NCT00772005|Secondary|Change From Baseline to Week 12 in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to week 12 in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460863|NCT00772005|Secondary|Change From Baseline to Endpoint in Sleep Latency|A sleep questionnaire was used to evaluate the effect of armodafinil treatment on the patient’s nighttime sleep. Patients completed the questionnaire to evaluate the sleep latency (time till fall asleep), duration, nighttime awakenings, and overall sleep quality. The questionnaire was assessed at the screening visit and at weeks 12 and 24 (or last visit after baseline). The data presented here represents the change from baseline to endpoint in reported sleep latency. There is no range of possible values, positive values represent prolongation of sleep latency.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Minutes||Standard Deviation|Mean
1460864|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1460865|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.|||percentage of participants|||Number
1460866|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 8.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1461046|NCT00771758|Secondary|Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming|The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = “not at all” to 5=“a very great deal.”|Day 10|Intent-to Treat population.|||percent of participants|||Number
1460867|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal ideation in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at endpoint.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1460868|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 24.|Week 24|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1460869|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions at week 16.|Week 16|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1460870|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior at week 8 in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Week 8|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1460871|NCT00772005|Secondary|Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint|The C-SSRS was performed at weeks 8, 16, and 24 (or last observation after baseline), and at any time if clinically indicated. The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The data presented here represents the percentage of patients in each arm found to have suicidal behavior in the judgment of a clinician and based upon a clinicians interpretation of the subject's responses to the C-SSRS questions.|Endpoint (Week 24 or last observation)|The number of participants analyzed represents the number of participants with evaluable data.|||Percentage of participants|||Number
1460872|NCT00772005|Secondary|Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460873|NCT00772005|Secondary|Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460874|NCT00772005|Secondary|Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460875|NCT00772005|Secondary|Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460876|NCT00772005|Secondary|Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460877|NCT00772005|Secondary|Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460878|NCT00772005|Secondary|Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460879|NCT00772005|Secondary|Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460880|NCT00772005|Secondary|Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score|Calgary Depression Scale for Schizophrenia (CDSS) assesses the level of depression in patients with schizophrenia. Nine items (depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression) are each scored on a 4-point scale: 0=absent, 1=mild, 2=moderate, 3=severe. The total score is a sum of the scores of each item and may range from 0 to 27. Higher score more severe pathology. Data presented here represents the change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460881|NCT00772005|Secondary|Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460882|NCT00772005|Secondary|Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460883|NCT00772005|Secondary|Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1461047|NCT00771758|Secondary|Clinician Global Impression of Change (CGIC) at End of Study|Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.|||percenatage of participants|||Number
1461048|NCT00771758|Secondary|Patient Global Impression of Change (PGIC) at End of Study|Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.|Day 10|Intent-to-Treat population.|||percenatage of participants|||Number
1460884|NCT00772005|Secondary|Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460885|NCT00772005|Secondary|Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460886|NCT00772005|Secondary|Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460887|NCT00772005|Secondary|Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460888|NCT00772005|Secondary|Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460889|NCT00772005|Secondary|Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score|Barnes Akathisia Rating Scale (BARS) measures presence and severity of drug-induced akathisia. Items related to objective akathisia, subjective awareness of restlessness, and distress related to restlessness were rated using a 4-point scale: 0=normal/no distress, 1=presence of restlessness/mild distress, 2=observable restlessness/moderate distress, 3=constant restlessness/severe distress. Total score is sum of scores of each item and range from 0-9. Higher score indicates greater restlessness and distress. Data represent change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460890|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 24, positive values represent worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460891|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 20, positive values represent worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1461049|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
1479088|NCT00633087|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.||||||
1460892|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 16, positive values represent worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460893|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 12, positive values represent worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460894|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 8, positive values represent worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460895|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 4, positive values represent worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460896|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 2, positive values represent worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460897|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to week 1, positive values represent worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460898|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score|The Simpson-Angus EPS Scale is a clinician-rated scale to assess parkinsonian and extrapyramidal symptoms (10 items) associated with antipsychotic medications. Each item is rated on a 5-point scale. In addition, this scale was used to evaluate and characterize adverse events of extrapyramidal symptoms. Total scores are calculated by summing the scores of each item (minimum 0, maximum 40) and dividing by the number of items (10). Scores can range from 0-4. A higher score indicates more severe symptoms. Data represents change from baseline to endpoint, positive values represent worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460899|NCT00772005|Secondary|Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 24, positive value represents worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1461050|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
1465559|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 78||Baseline and week 78|Treated Set with values for HbA1c at baseline and week 78. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1460900|NCT00772005|Secondary|Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 20, positive value represents worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460901|NCT00772005|Secondary|Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 16, positive value represents worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460902|NCT00772005|Secondary|Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 12, positive value represents worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460903|NCT00772005|Secondary|Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 8, positive value represents worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460904|NCT00772005|Secondary|Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 4, positive value represents worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460905|NCT00772005|Secondary|Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 2, positive value represents worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460906|NCT00772005|Secondary|Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to week 1, positive value represents worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460907|NCT00772005|Secondary|Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores|Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Data represents change from baseline to endpoint, positive value represents worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Deviation|Mean
1460908|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 24 with positive values demonstrating improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
1465560|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 66||Baseline and week 66|Treated Set with values for HbA1c at baseline and week 66. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1460909|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to week 12 with positive values demonstrating improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
1460910|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT]|The 4-Part Continuous Performance Test (CPT) is a component of the CNSVitalSigns cognitive battery. The 4-Part CPT assesses working memory. The patient was presented with targets and had to remember target presentation sequencing in order to respond to the directions. The complexity of the directions increased as the patient proceeded through the 4 parts of the test. Scoring is based on the number of correct responses, with a higher number indicating more correct responses. Data represents change from baseline to endpoint with positive values demonstrating improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses||Standard Error|Least Squares Mean
1460911|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 24 and a positive value represents improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minus errors||Standard Error|Least Squares Mean
1460912|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to week 12 and a positive value represents improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minus errors||Standard Error|Least Squares Mean
1460913|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test|The Shifting Attention Test is a test in the CNSVitalSigns cognitive battery. The Shifting Attention Test assesses attention and executive function. Patients were instructed to match geometric objects either by shape or by color. Composite Scoring presented here was calculated as the number of correct responses minus the number of errors. A higher score indicates more correct responses. The data represent the change from baseline to endpoint and a positive value represents improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Correct responses minue errors||Standard Error|Least Squares Mean
1460914|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 24 with positive values representing improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
1460915|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to week 12 with positive values representing improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
1460916|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)|Symbol-digit coding test (SDCT) is one test in the CNSVitalSigns cognitive battery. SDCT assesses speed of processing. Subject is taught to link numbers to digits. The test consists of serial presentations of screens, each of which contains a bank of 8 symbols above and 8 empty boxes below. The subject types in the number that corresponds to the symbol highlighted. Scoring is the number of correct responses generated in 2 minutes. A higher score indicates greater processing speed. Data represents change from baseline to endpoint with positive values representing improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Number of correct responses||Standard Error|Least Squares Mean
1461051|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
1463563|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1460917|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 24, with positive score showing improvement."|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460918|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to week 12, with positive score showing improvement."|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460919|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test|"CNSVitalSigns cognitive battery consists of 4 tests (Verbal Memory, Symbol-Digit Coding Test, Shifting Attention Test, Continuous Performance Test [CPT]). With Verbal Memory Test, patient asked to remember 15 words within a field of 15 distractors immediately and after twenty minute delay. Score is the sum of correct immediate hits, correct immediate passes, correct delayed hits, and correct delayed passes. Total score may range from 0 to 60, with a higher score indicating more correct responses. Data represents change from baseline to endpoint, with positive score showing improvement."|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460920|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 24 in the overall score with positive values signifying improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460921|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 12 in the overall score with positive values signifying improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460922|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to week 4 in the overall score with positive values signifying improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460923|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores|PSP is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. Data presented here represents change from baseline to endpoint in the overall score with positive values signifying improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460924|NCT00772005|Secondary|Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 24 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1461052|NCT00771758|Secondary|Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
1460925|NCT00772005|Secondary|Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 22 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 22|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460926|NCT00772005|Secondary|Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 20 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460927|NCT00772005|Secondary|Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 18 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 18|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460928|NCT00772005|Secondary|Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 16 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460929|NCT00772005|Secondary|Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 14 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 14|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460930|NCT00772005|Secondary|Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 12 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460931|NCT00772005|Secondary|Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 10 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 10|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460932|NCT00772005|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 8 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1461053|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
1461054|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
1460933|NCT00772005|Secondary|Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 6 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 6|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460934|NCT00772005|Secondary|Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 4 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1460935|NCT00772005|Secondary|Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 2 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460936|NCT00772005|Secondary|Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to week 1 in the CGI-S rating. A negative value indicates improvement.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460937|NCT00772005|Secondary|Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating|The CGI-S is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness. The data presented represents the change from baseline to endpoint in the CGI-S rating. A negative value indicates improvement.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460938|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) score indicates worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460939|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) score indicates worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460940|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) score indicates worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461055|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
1463564|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1460941|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) score indicates worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460942|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) score indicates worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460943|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) score indicates worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460944|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) score indicates worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460945|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) score indicates worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460946|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The hostility/excitement dimension is the sum of 2 positive symptoms (excitement, hostility) and 2 general psychopathology symptoms (uncooperativeness, poor impulse control). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) score indicates worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460947|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460948|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461056|NCT00771758|Secondary|Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
1460949|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460950|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460951|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460952|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460953|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460954|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenics. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms and posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460955|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in schizophrenic patients. Disorganized thought dimension is the sum of 1 positive symptom (conceptual disorganization), 1 negative symptom (difficulty in abstract thinking), and 5 general psychopathology symptoms (mannerisms/posturing, disorientation, poor attention, disturbance of volition, preoccupation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 7 to 49. Higher (positive) score indicates worsening. Data indicates change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460956|NCT00772005|Secondary|Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 24. Higher (positive) scores indicate worsening.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461057|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 10|Intent-to-Treat population.|||percentage of participants|||Number
1460957|NCT00772005|Secondary|Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 20. Higher (positive) scores indicate worsening.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460958|NCT00772005|Secondary|Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 16. Higher (positive) scores indicate worsening.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460959|NCT00772005|Secondary|Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 12. Higher (positive) scores indicate worsening.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460960|NCT00772005|Secondary|Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 8. Higher (positive) scores indicate worsening.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460961|NCT00772005|Secondary|Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 4. Higher (positive) scores indicate worsening.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460962|NCT00772005|Secondary|Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 2. Higher (positive) scores indicate worsening.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460963|NCT00772005|Secondary|Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to week 1. Higher (positive) scores indicate worsening.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460964|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. The anxiety/depression dimension is the sum of 4 general psychopathology symptoms (anxiety, guilt feelings, tension, depression). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 4 to 28. The data presented here represents the change from baseline to endpoint. Higher (positive) scores indicate worsening.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461058|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 5|Intent-to-Treat population.|||percentage of participants|||Number
1461059|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 3|Intent-to-Treat population.|||percentage of participants|||Number
1506851|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥2 to <12 Years||Day 21||||ug/mL||Full Range|Mean
1460965|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460966|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460967|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460968|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460969|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460970|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460971|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460972|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. Positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item is scored on a 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1463565|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1460973|NCT00772005|Secondary|Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)|PANSS rates severity of psychopathology in patients with schizophrenia. The positive symptoms dimension is the sum of 4 positive symptoms (delusions, hallucinatory behavior, grandiosity, suspiciousness/persecution), 1 negative symptom (stereotyped thinking), and 3 general psychopathology symptoms (somatic concern, unusual thought content, lack of judgment/insight). Each item scored on 7-point scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 8 to 56. Higher (positive) scores indicate worsening. Data show change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460974|NCT00772005|Secondary|Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460975|NCT00772005|Secondary|Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460976|NCT00772005|Secondary|Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460977|NCT00772005|Secondary|Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460978|NCT00772005|Secondary|Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460979|NCT00772005|Secondary|Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460980|NCT00772005|Secondary|Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1466363|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1460981|NCT00772005|Secondary|Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460982|NCT00772005|Secondary|Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)|PANSS rates the severity of psychopathology in patients with schizophrenia. The negative symptoms factor score includes 5 negative symptoms (blunted affect, emotional withdrawal, poor rapport, positive/apathetic social withdrawal, lack of spontaneity) and 2 general psychopathology symptoms (motor retardation, active social avoidance). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores may range from 7 to 49. Higher (positive) score indicates worsening. Data represents change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460983|NCT00772005|Secondary|Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 24.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460984|NCT00772005|Secondary|Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 20.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460985|NCT00772005|Secondary|Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 16.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460986|NCT00772005|Secondary|Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 12.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460987|NCT00772005|Secondary|Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 8.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460988|NCT00772005|Secondary|Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 4.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1488239|NCT00559988|Secondary|Mean Ventricular Heart Rate Reduction||1 year|Subjects with baseline and 1 year ventricular rate information|||beats per minute||Standard Deviation|Mean
1460989|NCT00772005|Secondary|Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 2.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460990|NCT00772005|Secondary|Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data show change from baseline to week 1.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460991|NCT00772005|Secondary|Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score|PANSS rates psychopathology severity in schizophrenics. 16 items form a General Psychopathology scale:somatic concern, anxiety, guilt feeling, tension, mannerisms/posturing, depression, motor retardation, uncooperative, unusual thoughts, disorientation, poor attention, poor judgment/insight, disturbance of volition, poor impulse control, preoccupation, social avoidance. Scored on severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores range from 16 to 112, higher (positive) score more severe pathology. Data shows change from baseline to endpoint.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1460992|NCT00772005|Secondary|Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 24. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1460993|NCT00772005|Secondary|Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 20. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1460994|NCT00772005|Secondary|Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 16. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1460995|NCT00772005|Secondary|Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 12. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1460996|NCT00772005|Secondary|Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 8. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1461060|NCT00771758|Secondary|Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2|Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.|Day 2|Intent-to-Treat population.|||percentage of participants|||Number
1460997|NCT00772005|Secondary|Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 4. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1460998|NCT00772005|Secondary|Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 2. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1460999|NCT00772005|Secondary|Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to Week 1. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1461000|NCT00772005|Secondary|Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score|PANSS is a clinician-rated instrument that rates the severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. The data here represents the change in the Positive scale score from baseline to endpoint. The scale may range from 7 to 49, higher (positive) score indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Deviation|Mean
1461001|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 24. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461002|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 20. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461003|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 16. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461004|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 12. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461129|NCT00771472|Secondary|Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||hours||Standard Deviation|Geometric Mean
1461005|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 8. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461006|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 4. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461007|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 2. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461008|NCT00772005|Secondary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates the severity of psychopathology in schizophrenics. 7 items measure negative symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Data represents change in Negative Rating Scale from baseline to week 1. Negative Scale score ranges from 7 to 49, higher (positive) score indicates more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461009|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 24, higher (positive) scores indicate more severe pathology.|Baseline and Week 24|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461010|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 20, higher (positive) scores indicate more severe pathology.|Baseline and Week 20|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461011|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represent the change in total score from baseline to week 16, higher (positive) scores indicate more severe pathology.|Baseline and Week 16|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461012|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 12, higher (positive) scores indicate more severe pathology.|Baseline and Week 12|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461130|NCT00771472|Secondary|Part I: Time at Which Cmax Occurs (Tmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||hours||Full Range|Median
1461013|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 8, higher (positive) scores indicate more severe pathology.|Baseline and Week 8|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461014|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 4, higher (positive) scores indicate more severe pathology.|Baseline and Week 4|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461015|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents the change in total score from baseline to week 2, higher (positive) scores indicate more severe pathology.|Baseline and Week 2|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461016|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1|PANSS rates severity of psychopathology in schizophrenics. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg.anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. The data here represents the change in total score from baseline to week 1 and higher (positive) scores indicate more severe pathology.|Baseline and Week 1|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461017|NCT00772005|Secondary|Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS is a clinician rating severity of psychopathology in patients with schizophrenia. 7 items measure positive symptoms (eg. delusions, hallucinations), 7 items measure negative symptoms (eg. blunted affect, social withdrawal), 16 items form a General Psychopathology scale (eg. anxiety, motor retardation). Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Total scores range from 30 to 210. Data represents change in total score from baseline to endpoint, higher (positive) scores indicate more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||units on a scale||Standard Error|Least Squares Mean
1461018|NCT00772005|Primary|Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint|PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.|Baseline and Endpoint (Week 24 or last observation after baseline)|The number of participants with evaluable data (who completed the assessments at baseline and endpoint) are presented.|||Units on a scale||Standard Error|Least Squares Mean
1461019|NCT00771953|Primary|Progression Free Survival|For determining progression-free survival, progression was determined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization until the first date that recurrent or progressive disease is objectively documented.||||days||95% Confidence Interval|Median
1461020|NCT00771927|Secondary|The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population|||Treatment-Emergent Adverse Events|||Number
1461131|NCT00771472|Secondary|Part I: Maximum Drug Concentration (Cmax)|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||µM||Standard Deviation|Geometric Mean
1461021|NCT00771927|Primary|The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study|"Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation.~Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake."|From Baseline up to 12 months|Safety Set (SS) population|||Treatment-Emergent Adverse Events|||Number
1461022|NCT00771914|Primary|the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment|The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.|4 hours|Each participant acted as own control since each received the intervention (placebo, aspirin, lovaza, and both aspirin and lovaza) and had these effects compared to baseline (four hour effect of each intervention).|||seconds||Standard Deviation|Mean
1461023|NCT00771901|Secondary|VLDL-triglyceride (TG) Concentration||Baseline and four weeks||||mmol/l||Standard Deviation|Mean
1461024|NCT00771901|Secondary|Insulin Sensitivity in the Liver|HISI (hepatic insulin sensitivity index). HISI is the inverse of the product of endogenous glucose production and plasma insulin concentration and provides an index of how well circulating insulin controls the amount of glucose supplied by the liver. A higher number is indicative of greater insulin sensitivity.|Baseline and four weeks||||100/ (µmol/min * uIU/mL)||Standard Deviation|Mean
1461025|NCT00771901|Primary|Body Composition|Fat mass (%)|Baseline and four weeks||||percentage||Standard Deviation|Mean
1461026|NCT00771875|Secondary|Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)||1 year||||participants|||Number
1461027|NCT00771875|Secondary|Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy||90 days||||participants|||Number
1461028|NCT00771875|Secondary|Incidence of Death||90 days||||participants|||Number
1461029|NCT00771875|Secondary|Mean Serum Creatinine|Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation|7, 14, 28, 60, 90 days and 1 year post therapy initiation||||mg/dL||Standard Deviation|Mean
1461030|NCT00771875|Secondary|Renal Allograft Survival||1 year after rejection treatment||||participants|||Number
1461031|NCT00771875|Secondary|Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy||Day 1||||participants|||Number
1461032|NCT00771875|Primary|Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection|"Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.~Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal."|1 year||||participants|||Number
1461033|NCT00771849|Secondary|Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.||28 days post-vaccination|SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.|||Participants|||Number
1461034|NCT00771849|Primary|Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.||Day 0 (before) and 28 days post-vaccination|SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1461035|NCT00771810|Secondary|Rescue Treatment for Hematopoiesis and Mucositis|"Number of subjects with a treatment emergent adverse event of hematopoiesis and mucositis who received rescue treatment as determined by the administration of:~Transfusions~Filgrastim or Pegfilgrastim~Erythropoietin~Palifermin"|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1461036|NCT00771810|Secondary|Alopecia|Number of subjects with a treatment emergent adverse event of alopecia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1461037|NCT00771810|Secondary|Mucositis|Number of subjects with a treatment emergent adverse event of mucositis|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1461038|NCT00771810|Secondary|Anemia|Number of subjects with a treatment emergent adverse event of anemia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1461039|NCT00771810|Secondary|Neutropenia|Number of subjects with a treatment emergent adverse event of neutropenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1461040|NCT00771810|Secondary|Lymphopenia as Determined by Lymphocyte Count|Number of subjects with a treatment emergent adverse event of lymphopenia|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1461041|NCT00771810|Secondary|Chemotherapy Dose Intensity and Dose Density|Mean percentage of cycles where projected (target) chemotherapy dose was maintained|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
1461042|NCT00771810|Secondary|Treatment Cycles With Platelets Counts Below 25,000/mm3|Mean percentage of treatment cycles where platelets counts were below 25,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the intention to treat population.|||Percentage of cycles||Full Range|Mean
1461043|NCT00771810|Secondary|Subjects With Platelet Counts Below 50,000/mm3|Number of subjects who experienced a platelet count below 50,000/mm3|During a maximum of six 3-week chemotherapy cycles|The number of participants for analysis was the safety population.|||Participants|||Number
1463566|NCT00754065|Secondary|Number of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1461061|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Placebo)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Placebo arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
1461062|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning."|10 days|Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
1461063|NCT00771758|Secondary|Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)|"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via Interactive Voice Response (IVR) system in the morning."|10 days|Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.|||participants|||Number
1461064|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 10|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 10|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1461065|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 5|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 5|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1461066|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 3|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 3|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1461067|NCT00771758|Secondary|Summary of Subject Satisfaction With Treatment on Day 2|Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.|Day 2|Intent-to-Treat population.|||Scores on a scale||Standard Deviation|Mean
1461068|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study|"The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.~Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved."|Day 10|Intent-to-Treat subjects.|||second||Standard Deviation|Mean
1461069|NCT00771758|Secondary|Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study|The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.|||chair stands||Standard Deviation|Mean
1461070|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study|The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.|Day 10|Intent-to-Treat subjects.|||seconds||Standard Deviation|Mean
1461071|NCT00771758|Secondary|Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study|The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.|Day 10|Intent-to-Treat subjects.|||meters||Standard Deviation|Mean
1461072|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.|10 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461073|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.|5 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461074|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.|3 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461386|NCT00768989|Secondary|Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
1461075|NCT00771758|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days|The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.|2 Days|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461076|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 10 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461077|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 5 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.|5 Days (120 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461078|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 3 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.|3 Days (72 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461079|NCT00771758|Secondary|Total Pain Relief (TOTPAR) Over 2 Days|Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.|2 Days (48 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461080|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 10 Days|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.|10 Days (216 Hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461081|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 5 Days (SPID120)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.|5 Days (120 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461082|NCT00771758|Secondary|Sum of Pain Intensity Difference Over 2 Days (SPID48)|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.|2 Days (48 hours)|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461083|NCT00771758|Secondary|50% Responder Rate on Day 10.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1461084|NCT00771758|Secondary|30% Responder Rate on Day 10.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).|Day 10|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1461085|NCT00771758|Secondary|50% Responder Rate on Day 5.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1466364|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 3|Subject Satisfaction - ease of locating the deflation touch pads|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1461086|NCT00771758|Secondary|30% Responder Rate on Day 5.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).|Day 5|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1461087|NCT00771758|Secondary|50% Responder Rate on Day 3.|The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1461088|NCT00771758|Secondary|30% Responder Rate on Day 3.|The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).|Day 3|modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.|||percentage of participants|||Number
1461089|NCT00771758|Primary|Sum of Pain Intensity Difference Over 3 Days (SPID72)|"Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.~The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects."|3 Days (72 hours)|The modified Intent-to-Treat(mITT) population was defined as all randomized patients who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.|||Scores on a scale||Standard Deviation|Mean
1461090|NCT00771745|Secondary|Malignancy||Undefined|||||||
1461091|NCT00771745|Secondary|Serum Creatinine||Post-operative days 1-7, 30, 90 and 6 months|||||||
1461092|NCT00771745|Secondary|Severity of Biopsy-proven Rejection Using Banff 97 Criteria||Not defined|||||||
1461093|NCT00771745|Secondary|Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection||Not defined|||||||
1461094|NCT00771745|Secondary|Incidence of Infections||Not defined|||||||
1461095|NCT00771745|Secondary|Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.||Ongoing|||||||
1461096|NCT00771745|Primary|Composite End Point of Acute Rejection, Graft Loss or Patient Death|Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death|6 months|Patients received tacrolimus (goal level 10-15 ng/mL) and mycophenolate mofetil (2gm daily) at time of transplant. Methylprednisolone (MP), acetaminophen, and diphenhydramine were given as premedication for each rATG dose (500mg MP 1st dose, 250mg MP subsequent 2 doses, 125mg MP 4th dose).|||participants|||Number
1461097|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1461098|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)|As measured by a CDAI score of < 150 points.|Baseline to Week 22|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1461099|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 8|As measured by a CDAI score of < 150 points.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1461100|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 8|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 8|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1461101|NCT00771667|Secondary|Number of Participants With Clinical Response at Week 4|As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 4|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1461102|NCT00771667|Secondary|Number of Participants With Clinical Remission at Week 6|As measured by a CDAI score of < 150 points.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1461103|NCT00771667|Primary|Number of Participants With Clinical Response at Week 6|As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.|Baseline to Week 6|All participants who were randomized, regardless of whether they received study agent.|||Participants|||Number
1461104|NCT00771615|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs).|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1461105|NCT00771615|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.“Any” was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|From Day 0 to Day 42|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1461106|NCT00771615|Secondary|Number of Subjects With Medically-attended Adverse Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 378|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1461107|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1461108|NCT00771615|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.|Within the 7-day (Days 0-6) post vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.|||Subjects|||Number
1461109|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461110|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461111|NCT00771615|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (< 1:28, recorded 1:14 if < 1:28) to ≥ 1:56 in the subjects.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461112|NCT00771615|Secondary|Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461113|NCT00771615|Secondary|Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.|MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1461114|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||fold increase||95% Confidence Interval|Geometric Mean
1461115|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461148|NCT00771173|Primary|Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments|The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts.|24 hours|Per Protocol|||centimeters||Standard Deviation|Mean
1461116|NCT00771615|Secondary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461117|NCT00771615|Secondary|HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1461118|NCT00771615|Secondary|HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 0 to Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||fold increase||95% Confidence Interval|Geometric Mean
1461119|NCT00771615|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.|Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10|At Day 0, Day 10, Day 42 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1461120|NCT00771615|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 0 to Day 42 and at Day 0 to Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461121|NCT00771615|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Titer||95% Confidence Interval|Geometric Mean
1461122|NCT00771615|Primary|Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461123|NCT00771615|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.|At Day 10|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.|||Subjects|||Number
1461124|NCT00771602|Secondary|52 Week Toxicity Rate|The definition of toxicities include any >/= grade 3 non-hematologic toxicity, >/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.|52 weeks|||||||
1461125|NCT00771602|Secondary|Progression-free Survival|Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.|52 weeks or until disease progression|||||||
1461126|NCT00771602|Primary|Number of Patients With Molecular Remissions at 52 Weeks|Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.|52 weeks|No analysis available participant ineligible for evaluation; study terminated due to slow accrual.||||||
1461127|NCT00771537|Primary|Willingness to Participate in a HIV Vaccine Clinical Trial|Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).|Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.|Only participants who answered the Willingness to Participate questions on the survey were included in these analyses.|||units on a scale||Standard Deviation|Mean
1461128|NCT00771537|Primary|Number of Participants Who Accepted Rapid HIV Testing.|Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.|During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.||||participants|||Number
1461149|NCT00771056|Secondary|Time to Next Treatment|number of months to time from last HCQ dose to next CLL treatment|1 yr|only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose|||months||Full Range|Mean
1461132|NCT00771472|Primary|Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)|"A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):~Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC~Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment~Grade 4 neutropenia lasting at least 5 days~Grade 4 thrombocytopenia~Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator~Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies"|Day 1 to Day 28||||participants|||Number
1461133|NCT00771472|Secondary|Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])|"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat."|Days 1 & 28 of Cycle 1|Number of participants with samples at the specified time point|||µM*hr||Standard Deviation|Geometric Mean
1461134|NCT00771472|Primary|Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)|A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.|Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)||||participants|||Number
1461135|NCT00771407|Secondary|Stoma Quality of Life||Serially over 24 months|||||||
1461136|NCT00771407|Secondary|Stoma Complications||more than 1 month postoperatively|||||||
1461137|NCT00771407|Secondary|Stoma Complications||30 days|||||||
1461138|NCT00771407|Primary|Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.||24 months|Efficacy Evaluable Population (received assigned treatment, completed all protocol-required evaluations, no major protocol violations).|||participants|||Number
1461139|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.||||||
1461140|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)|Clinical response at DCIV defined as: 1) Improved-All or most pretherapy signs and symptoms of infection have improved and no additional antibiotic is required, 2) Failure-No response to therapy, persistence or progression of pretherapy signs and symptoms, 3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.|After at least 4 days of IV therapy|This analysis was not completed due to early termination of the study.||||||
1461141|NCT00771316|Primary|Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit|Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.|5 to 9 days post therapy|This analysis was not completed due to early termination of the study.||||||
1461142|NCT00771277|Secondary|Zarit Burden Inventory|Caregiver burden, as measured by the 12-item Zarit Burden Interview (Bédard et al., 2001; Zarit, Reever, & Bach-Peterson J, 1980). Burden includes concepts such as lack of time because of care, strain, restriction of life, etc. Items are scored from never (0) to nearly always (4), and higher total scores indicate greater burden. Total scores range from 0 to 88.|baseline||||units on a scale||Standard Deviation|Mean
1461143|NCT00771277|Secondary|PHQ-9|The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) assesses caregiver depression and anxiety on a scale from not at all (0) to nearly every day (3), with higher total scores indicating greater symptoms. Scores range from 0-27. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression respectively.|baseline||||units on a scale||Standard Deviation|Mean
1461144|NCT00771277|Primary|Number of Participants Who Reported 5 Themes|Six caregivers of TBI patients were interviewed; responses were transcribed and coded; inter-rater agreement was calculated. Themes were lack of understanding about TBI and its long-term effects and the differences between TBI and PTSD, privacy concerns, independence, fear of negative employment/financial repercussions, and difficulty in interactions with the Department of Defense (DoD) and the Department of Veterans Affairs (VA)|collected over 3 interviews of approximately 1 hour each||||participants|||Number
1461145|NCT00771264|Primary|"The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting Moderately or Markedly Improved Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis."|A responder was defined as reporting bladder symptoms as moderately or markedly improved on a 7-level GRA at week 13 after completing 12, 30-minute, consecutive weekly intervention sessions.|13 weeks|Intent to treat|||participants|||Number
1461146|NCT00771238|Secondary|Cost of Rental Beds|Cost was measured for Beds/Surfaces that are rented for Wound management / prevention purposes only|End of study|Tertiary Care ICU patients|||US Dollars|||Number
1461147|NCT00771238|Primary|Indicence of Pressure Ulcers|New pressure ulcers were assessed|at the end of study period (21 days)|Tertiary Care ICU patients|||participants|||Number
1461150|NCT00771056|Primary|Percentage of Participants With Response|Percentage of participants with a reduction of the absolute lymphocytic count- ALC|1 yr||||percentage of participants|||Number
1461152|NCT00770991|Secondary|Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.|A pooled analysis of all participants was used for biomarker results. Tissue from normal mucosa and rectal polyps were obtained to assay KI 67 (proliferation) and TUNEL at baseline and end of treatment. A decrease in the value of KI 67 implies lower proliferation while an increase in TUNEL is suggestive of an increase in apoptosis.|baseline and 36 weeks||||percentage of brown staining of cells||Standard Deviation|Mean
1461153|NCT00770991|Primary|Change From Baseline to End of Study in Number of Rectal Polyps||Baseline and 36 weeks||||polyps||Standard Deviation|Mean
1461154|NCT00770965|Secondary|Investigator Global Assessment (IGA) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, day 1, weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32|||||||
1461155|NCT00770965|Secondary|Change From Baseline in PASI|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, weeks 12, 14, 16, 20, 24, 28 and 32|||||||
1461156|NCT00770965|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores|This study was not powered for efficacy. Due to audit findings at one site, which included 65 participants, all participants enrolled at the site were excluded from the planned efficacy analyses. As a result, efficacy could not be analyzed due to an insufficient number of participants.|baseline, week 4|||||||
1461157|NCT00770913|Primary|Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)|Grade N indicates a normal appearance of lower esophageal mucosa|8 weeks|The primary analysis was on the full analysis set (FAS) population.|||Percentage of Participants|||Number
1461158|NCT00770861|Secondary|Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF).|The secondary efficacy parameter was the change from baseline in mean trough seated SBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated SBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)||||mm Hg||Standard Deviation|Mean
1461159|NCT00770861|Primary|Change From Baseline in Trough Seated DBP at Week 8(LOCF).|The primary efficacy parameter was the change from baseline in mean trough seated DBP at Week 8. The average of three consecutive BP measurements would be the mean trough seated DBP value.|From baseline visit 7 (week 0) to end of double-blind treatment phase visit 11 (week 8)||||mm Hg||Standard Deviation|Mean
1461160|NCT00770809|Secondary|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3|The type and grade of treatment-related toxicity will be tabulated by treatment arm.|Up to 30 days post-treatment|||||||
1461161|NCT00770809|Secondary|Time to First Failure|Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.|Time from study entry to any recurrence ( up to 10 years)|||||||
1461162|NCT00770809|Secondary|Relapse-free Survival (RFS)|Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method.|Time from surgery to any recurrence (up to 10 years)|||||||
1461163|NCT00770809|Secondary|Overall Survival|Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method|Time from randomization to death or last follow-up (up to 10 years)|||||||
1461164|NCT00770809|Secondary|Radiographic Response Rate (at Completion of Neoadjuvant Therapy)|Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).|Week 16|||||||
1461165|NCT00770809|Secondary|Pathologic Stage in the Breast and Axilla|Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system.|At time of surgery|||||||
1461166|NCT00770809|Primary|pCR Rate|Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.|At time of surgery|Participants who did not start protocol therapy or withdrew prior to surgery are excluded. Participants who did not undergo surgery are considered no having a pCR.|||percentage of participants||95% Confidence Interval|Number
1461167|NCT00770770|Primary|Visual Acuity|To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.|3 months||||Letters||Standard Error|Mean
1461168|NCT00770757|Post-Hoc|Survival Rate of CC-4047 Responders||Median follow-up 5.6 years (4.2-5.6 years)|Five participants have died and these were the participants who did not respond or were removed from study prior to cycle 3 due to adverse events.|||percentage of participants|||Number
1461187|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.60%)|The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461169|NCT00770757|Post-Hoc|Chronic Graft-versus-host Disease Global Score at the Start/End of the Study|"Global scoring of chronic GvHD consists of questions about various organs including skin, genital tract, lungs, liver, and multiple others. The physician scores each organ from 0 to 3. Score 0 means the patient has no symptoms. Score 1 means the patient has mild symptoms. Score 2 means the patient has moderate symptoms. Score 3 means the patient has severe syptoms.~Mild scoring of chronic GvHD is only 1 or 2 organs or site (except the lung). No clinically significant functional impairment (maximum of score 1 in all affected organs or sites)~Moderate scoring of chronic GvHD is at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) or 3 or more organs or sites with no clinically significant functional impairment (maximum of 1 in all affected orgnas or sites)~Severe scoring of chronic GvHD is a major disability caused by chronic GvHD (score of 3 in any organ or site) and lung function score >=2."|1 year after last dose of CC-4047||||participants|||Number
1461170|NCT00770757|Post-Hoc|Organ System Response||1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable|||participants|||Number
1461171|NCT00770757|Secondary|Safety as Measured by the Most Common Adverse Effects and Reasons for Dose Reductions or Study-discontinuation|-Toxicities will be graded according to the NCI CTCAE v3.0.|30 days after last dose of CC-4047 or until resolution of event||||participants|||Number
1461172|NCT00770757|Primary|Overall Response (Complete Response + Partial Response + Other)|"CR is defined as complete resolution in all of signs and symptoms at all affected organs and tissues~PR is defined as improvement in greater than or equal to 1 organ/tissue with no progression in any other affected organ/tissue~Improvement in chronic GvHD symptoms less than what meets the definition of a PR is defined as other~Progressive disease is defined as failure of therapy to control chronic GvHD despite increasing the dose of primary therapy or adding second line treatments~No response is defined as no change in disease."|1 year after last dose of CC-4047|4 participants discontinued treatment before the third cycle because of adverse-effects and were not evaluable|||participants|||Number
1461173|NCT00770692|Secondary|Mean Change From Baseline in Total Number of Awakenings|Based on subjective symptoms, the participants recorded their number of awakenings defined as total number of spontaneous awakenings from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total number of awakenings of the overall period assessment - total number of awakenings at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||Number of Awakenings||Standard Deviation|Mean
1461174|NCT00770692|Secondary|Mean Change From Baseline in Total Sleep Time|Based on subjective symptoms, the participants recorded their total sleep time defined as total sleeping time from bedtime to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the total sleep time of the overall period assessment - total sleep time at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
1461175|NCT00770692|Secondary|Mean Change From Baseline in Wake Time After Sleep Onset (WASO)|Based on subjective symptoms, the participants recorded their WASO defined as total awakening time from falling asleep to final awakening in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the WASO of the overall period assessment - WASO at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
1461188|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (0.30%).|The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461189|NCT00770653|Secondary|Change From Baseline in Von-Willebrand Factor.|The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Error|Least Squares Mean
1461176|NCT00770692|Primary|Incidence of Adverse Events|"Incidence of adverse events was defined as: (number of participants with adverse events/ number of participants analyzed in the safety analysis set)*100.~An adverse event was defined as any unwanted or untoward disease or its symptom, sign, or abnormality in laboratory parameters in a subject who receives a study drug. An adverse event does not necessarily have a causal relationship with the study drug. The investigator or subinvestigator evaluated adverse events and recorded the results in the case report form (CRF). The investigator or subinvestigator recorded all adverse events occurring after the start of study treatment in the CRF, irrespective of the causal relationship with the study drug or the study procedures. All data collected from the follow-up was recorded in CRF."|Up to 25 weeks (24 weeks treatment period & 1 week follow-up)|Safety analysis set: All 161 non-elderly participants who were enrolled in the treatment period were included. All 164 elderly patients who were enrolled in the treatment period were included. The participant who was excluded from the efficacy analysis set was included in the safety analysis set because the participant had evaluable safety data.|||Percentage of Participants|||Number
1461177|NCT00770692|Secondary|Mean Change From Baseline In Sleep Latency|Based on subjective symptoms, the participants recorded their sleep latency (the amount of time measured in minutes it takes to fall asleep) in a sleep diary questionnaire for the week preceding the start of the study treatment (the day on which the patient was enrolled in the treatment period), as well as between the day on which the study treatment started and the Week 4 visit. For pre-treatment (screening period), the representative value was calculated from the data of the 7 days preceding enrollment in the treatment period. A median of all the data between the day of enrollment in the treatment period and the day before dose escalation judgment was presented as the data of the overall period. The change was calculated as the sleep latency of the overall period assessment - sleep latency at baseline (screening period).|Baseline (screening period) and 4 weeks of treatment|Efficacy analysis set: all of the 161 non-elderly participants who were enrolled in the treatment period. Among the 164 elderly participants who were enrolled in the treatment period, 163 (80 in the 1 mg group and 83 in the 2 mg group) were included in the efficacy set, excluding 1 participant in the 1 mg group who had no evaluable efficacy data.|||minutes||Standard Deviation|Mean
1461178|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Legs||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.||||||
1461179|NCT00770679|Primary|Change in Endothelial Function as Measured on MRI in the Arms||chance from baseline to end of study, up to 5 weeks|No data was collected for this outcome measure. The outcome was not able to be calculated based upon data obtained and programs and investigator capabilities.||||||
1461180|NCT00770679|Primary|Mean Change in Low Density Lipoprotein (LDL)|Serum LDL, mg/dL (baseline LDL-follow-up LDL)|Change from baseline to follow-up, up to 5 weeks|3 participants were lost to follow-up, 3 participants did not have LDL values collected/reported at follow-up|||mg/dL||Standard Deviation|Mean
1461181|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (60.00).|The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461182|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (30.00).|The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461183|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (12.00).|The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461184|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (6.00).|The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461185|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (3.00).|The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461186|NCT00770653|Secondary|Change From Baseline in Erythrocyte Deformability (1.20).|The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||percent||Standard Deviation|Mean
1461190|NCT00770653|Secondary|Change From Baseline in E-Selectin.|The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1461191|NCT00770653|Secondary|Change From Baseline in Platelet Function.|The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||sec||Standard Error|Least Squares Mean
1461192|NCT00770653|Secondary|Change From Baseline in Thromboxane B2.|The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||pg/mL||Standard Error|Least Squares Mean
1461193|NCT00770653|Secondary|Change From Baseline in Soluble Vascular Cell Adhesion Molecule.|The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1461194|NCT00770653|Secondary|Change From Baseline in Soluble Intracellular Adhesion Molecule.|The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1461195|NCT00770653|Secondary|Change From Baseline in Matrix Metallo Proteinase-9.|The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||ng/mL||Standard Error|Least Squares Mean
1461196|NCT00770653|Secondary|Change From Baseline in Soluble CD40 Ligand.|The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||pg/mL||Standard Error|Least Squares Mean
1461197|NCT00770653|Secondary|Change From Baseline in Nitrotyrosine.|The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from Schwerin, Berlin, Hanover and Münster study sites. Last observation carried forward was used (LOCF) in case of premature termination.|||nmol/L||Standard Error|Least Squares Mean
1461198|NCT00770653|Secondary|Intake of Study Medication Greater Than 80% and Less Than 120%.|The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||participants|||Number
1461199|NCT00770653|Secondary|Change From Baseline in Diastolic Blood Pressure.|The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mmHg||Standard Deviation|Least Squares Mean
1461200|NCT00770653|Secondary|Change From Baseline in Systolic Blood Pressure.|The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mmHg||Standard Error|Least Squares Mean
1461201|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).|The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/L||Standard Deviation|Mean
1461202|NCT00770653|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Original).|The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/L||Standard Error|Least Squares Mean
1461203|NCT00770653|Secondary|Change From Baseline in Adiponectin.|The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||μg/mL||Standard Error|Least Squares Mean
1461847|NCT00764881|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1461204|NCT00770653|Secondary|Change From Baseline in Fasting Glucose.|The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461205|NCT00770653|Secondary|Change From Baseline in Fasting Intact Proinsulin.|The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||pmol/L||Standard Error|Least Squares Mean
1461206|NCT00770653|Secondary|Change From Baseline in Glycosylated Hemoglobin.|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461207|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol.|The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461208|NCT00770653|Secondary|Change From Baseline in Low-Density Lipoprotein Subfractions.|The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. The number of participants for analysis was derived from a subgroup of participants from the Mainz, Germany study site. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461209|NCT00770653|Secondary|Change From Baseline in Triglycerides.|The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461210|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.|The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461211|NCT00770653|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol.|The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analyses was performed for the full analysis and per-protocol set. This condition was not fulfilled in some participants who were excluded. Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461212|NCT00770653|Primary|The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.|The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline.|Baseline and Week 24.|Analysis was performed on participants with at least one valid baseline and post-baseline measurement. This condition was not fulfilled in 17 participants who were excluded from the all-participants-randomized set, leading to a full-analysis-set of 288 (146 vs. 142). Last observation carried forward was used (LOCF) in case of premature termination.|||mg/dL||Standard Error|Least Squares Mean
1461213|NCT00770588|Secondary|Adverse Event|Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated.|AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitored||||Participants|||Number
1461214|NCT00770588|Secondary|Symptom Improvement|Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement.|at randomization, every 6 weeks until disease progression, and at discontinuation.||||Participants|||Number
1461215|NCT00770588|Secondary|Disease Control Rate (DCR)|DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase|Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.|||||||
1461216|NCT00770588|Secondary|Objective Tumour Response (ORR)|The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.||||Participants|||Number
1461258|NCT00770146|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1461217|NCT00770588|Secondary|Overall Survival (OS)|The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive.|The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive.||||month||95% Confidence Interval|Median
1461218|NCT00770588|Primary|Progression Free Survival (PFS)|PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.||||month||95% Confidence Interval|Median
1461219|NCT00770562|Secondary|Percentage of Participants With an Initial Complete Response|Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.|||percentage of participants|||Number
1461220|NCT00770562|Secondary|Percentage of Participants With an Initial Response|Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.|Week 4|ITT population; excluding participants who received additional steroid therapy or IV Ig course during the first month of therapy.|||percentage of participants|||Number
1461221|NCT00770562|Primary|Percentage of Participants With a Sustained Response|Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.|Week 24|The Intent-to-Treat (ITT) population includes all participants who were randomized, who received at least (<) 1 dose of study medication, and who had at least 1 follow-up contact.|||percentage of participants|||Number
1461222|NCT00770510|Primary|Sleep Latency (SL)|The subjective measure, SL, defined as the amount of time measured in minutes it takes to fall asleep was based on participant-reported subjective assessments of sleep disturbance and was obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Standard Deviation|Mean
1461223|NCT00770510|Secondary|Number of Awakenings (Objective & Subjective)|"Number of awakenings defined as the total number of spontaneous awakenings from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective number of awakenings was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Number of awakenings||Full Range|Median
1461224|NCT00770510|Secondary|Wake Time After Sleep Onset (WASO)- Objective & Subjective|"Wake Time After Sleep Onset (WASO) defined as total awakening time from falling asleep to final awakening was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective WASO was based on PSG assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Full Range|Median
1461225|NCT00770510|Secondary|Sleep Efficiency|"Sleep efficiency (SE) was an assessment obtained from PSG during the treatment period and was defined as the ratio of total sleep time to the total time in bed of 8 hours * 100, expressed as a percent.~PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the patient's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Percentage of time asleep of 8 hours||Full Range|Median
1461259|NCT00770146|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1461226|NCT00770510|Secondary|Total Sleep Time (Objective & Subjective)|"Total sleep time defined as total sleeping time from bedtime to final awakening (measured in minutes) was objectively determined by polysomnography and subjectively determined based on participant-reported measures following treatment.~The objective total sleep time was based on PSG-based assessments. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.~The subjective measure was based on participant-reported subjective assessments of sleep disturbance and were obtained from participants' responses to morning questionnaires. Questionnaires were administered during each visit during the treatment period."|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Full Range|Median
1461227|NCT00770510|Primary|Latency To Persistent Sleep (LPS)|The objective measure, LPS, defined as the amount of time measured in minutes it takes to fall asleep was based on polysomnography (PSG) objective assessments of sleep disturbance. PSG recording was performed according to a manual for overnight PSG. The start time for PSG recording was individualized and scheduled within +/- 30 minutes of the participant's median bedtime as recorded in the sleep diary. During the screening period, participants were provided a diary in which they recorded the time of lights out before bedtime for 1 week pror to PSG evaluations. PSG recording duration for scoring was 8 hours. PSG data recorded during treatment were centrally scored by a trained expert.|10 days (5 intervals of two consecutive nights)|Full analysis set: includes randomized participants who were administered >= 1 dose of study medication and had evaluable data for the primary efficacy assessments from any of the 5 treatment intervals.|||Minutes||Standard Deviation|Mean
1461228|NCT00770484|Primary|Maximal Oxygen Consumption Capacity (VO2 Max)||Over approximately 30 minutes, within 2 hours of receiving each intervention.||||mL/kg/min||Standard Error|Mean
1461229|NCT00770432|Secondary|Binary Outcomes (Bowel Movement Satisfaction, Bowel Moevement Sense of Completion).|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|24 hours to 3 days after last dose of seven day treatment period.|||||||
1461230|NCT00770432|Secondary|Diary Ratings in Visual Analog Scale Format (Bowel Movement Control, Gas, Bloating, Abdominal Discomfort/Cramping, Well-being)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed.|24 hours to 3 days after last dose of seven day treatment period.|||||||
1461231|NCT00770432|Primary|Number of Participants With a Complete Resolution at the Final Visit|A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.|24 hours to 3 days after last dose of seven day treatment period.|Per-Protocol Population|||Participants|||Number
1461232|NCT00770367|Secondary|NOx f2-isoprostanes|Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress|3 months|36 adults with diabetes enrolled in the study, and 31 completed the 7-month protocol. Adherence with medication was 93% during the trial according to pill counts at the final visit. Participants were allowed to take their other regular medications during the trial.|||Oxidative stress||Standard Error|Mean
1461233|NCT00770367|Primary|Asymmetric Dimethylarginine (ADMA) Level|Labs measured micro moles per liter of ADMA levels in participants.|3 months|Recruited 36 participants per randomization.1st analysis is serum Asymmetric Dimethylarginine ADMA at 12 weeks b/w groups.|||umol/L||95% Confidence Interval|Mean
1461234|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at TOC|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1461235|NCT00770341|Secondary|Study Investigators' Assessment of Clinical Response at EOT|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1461236|NCT00770341|Secondary|EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1461237|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC|"Response = eradicated or presumed eradicated.~Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen.~Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed Cured or Improved by the investigator and the participant did not receive potentially effective antibiotics for the pathogen."|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1461238|NCT00770341|Secondary|EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).|Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT.|7-14 days for SSTI, 14-42 days for septicemia and RIE|MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population.|||Participants|||Number
1506852|NCT00422422|Primary|Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years||Day 21||||ug/mL||Full Range|Mean
1461239|NCT00770341|Primary|Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)|"Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT).~MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline."|7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)|MITT-MRSA; One participant with possible MRSA RIE was enrolled. This participant was excluded from the efficacy population.|||Participants|||Number
1461240|NCT00770328|Secondary|Changes in the Relationship Between PAI-1, CRP, and TNF-a With Therapy.||Baseline and 8 weeks|Unable to complete analysis due to TNF-a assay failure (see Outcome measure #3)||||||
1461241|NCT00770328|Secondary|Change in TNF-alpha Level||Baseline and 8 weeks|TNF-a assay did not work properly. Meaningless data resulted including negative values which are impossible.||||||
1461242|NCT00770328|Secondary|Change in CRP Level||Baseline and 8 weeks||||mg/dl||Standard Error|Mean
1461243|NCT00770328|Primary|Change in PAI-1 Level||Baseline and 8 weeks||||ng/ml||Standard Error|Mean
1461244|NCT00770315|Secondary|Average Rhinoconjunctivitis DMS for the Peak RS|Rhinoconjunctivitis DMS was based on participant use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1461245|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Entire RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1461246|NCT00770315|Secondary|Average Rhinoconjunctivitis DSS for the Peak RS|The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1461247|NCT00770315|Secondary|Average Combined Rhinoconjunctivitis DSS and DMS Over the Entire RS|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|Approximately 5 weeks|The FAS population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1461248|NCT00770315|Primary|Combined (Sum of) Rhinoconjunctivitis Daily Symptom Score (DSS) and Daily Medication Score (DMS) Averaged Over the Peak Ragweed Season (RS)|The total combined score is a composite endpoint that combines the rhinoconjuntivitis DSS and the rhinoconjunctivitis DMS. The rhinoconjunctivitis DSS consisted of a total of 6 symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes and watery eyes) that were measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18), with a lower score indicating less rhinoconjunctivitis symptoms. Rhinoconjunctivitis DMS was based on use of specific study-provided rescue medication, with different rescue medications being assigned different scores/dose unit (score range: 0-36), with a lower score indicating less rhinconjunctivitis medication use. The sum of the rhinoconjunctivitis DSS+DMS could range from 0 to 54, with a lower score indicating less rhinoconjuntivitis symptoms and medication use. Raw means were converted to adjusted means using an ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects.|The 15-day period during the ragweed season with the highest moving pollen average|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study medication and had at least one post-randomization efficacy measurement.|||score on a scale||Standard Error|Mean
1461260|NCT00770146|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||ratio||Standard Deviation|Mean
1461387|NCT00768989|Secondary|Mean Change From Baseline in Electrocardiogram Findings|The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.|From Baseline to Week 24|All randomized participants who received at least 1 dose of study medication.|||msec||Standard Error|Mean
1461249|NCT00770289|Secondary|Number of Participants With Residual Symptoms in Case of Non Remission|Number of participants with residual symptoms who did not achieve remission was assessed. Remission according to HAM-D: HAM-D17 score =< 7 or HAM-D7 score =<3. Remission according to BDI: BDI score <10. HAM-D17: assessed 17 items associated with MD. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: assessed 7 items associated with MD. Total score: 0 to 26. BDI assessed severity of depressive symptoms. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. The total score: 0 to 63. For all the 3 scales, higher score indicated more severe depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||participants|||Number
1461250|NCT00770289|Secondary|Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)|HAM-D17: clinician-administered scale; assesses 17 items related to major depression (MD). Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: subset of HAM-D17; assesses 7 items related to MD. Total score: 0 to 26. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, physical symptoms of fatigue, weight loss, lack of interest in sex. Individual item scored on 4 point scale (0 to 3); 0=absent, 3=most severe. Total score: 0 to 63. For all the 3 scales, higher score represented more depression.|Baseline, Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available at baseline and were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1461251|NCT00770289|Secondary|Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)|Remission according to BDI: BDI score less than (<) 10. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression.|Week 12|ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1461252|NCT00770289|Primary|Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)|Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.|Week 12|Intent-to-treat (ITT) population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
1461253|NCT00770211|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1461254|NCT00770211|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder as having a rating of none or mild|||Participants|||Number
1461255|NCT00770211|Secondary|1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1461256|NCT00770211|Secondary|Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases. Responder defined as having a rating of none or mild|||Participants|||Number
1461257|NCT00770211|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.|||Particpants|||Number
1491274|NCT00538642|Primary|Insulin Sensitivity|Euglycemic clamp method|Baseline||||mg glucose/kg.min/μIU insulin||Standard Deviation|Mean
1461261|NCT00770146|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1461262|NCT00770146|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1461263|NCT00770146|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1461264|NCT00770146|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1461265|NCT00770146|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1461266|NCT00770146|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1461267|NCT00770146|Other Pre-specified|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1461268|NCT00770146|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1461269|NCT00770146|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1461270|NCT00770146|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1461271|NCT00770146|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1461272|NCT00770146|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1461273|NCT00770146|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Standard Deviation|Mean
1461388|NCT00768989|Secondary|Mean Change From Baseline in Total Bilirubin Level||From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication.|||mg/dL||Standard Error|Mean
1461274|NCT00770146|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1461275|NCT00770146|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||percentage of baseline||Inter-Quartile Range|Median
1461276|NCT00770146|Primary|Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1461277|NCT00770146|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald’s calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides >400 mg/dL. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Inter-Quartile Range|Median
1461278|NCT00770120|Secondary|Frequency and Severity of Toxicities||Weekly during the first 8 weeks of treatment, then every 4 weeks while on treatment, then every 8 weeks until disease progression, then every 6 months thereafter.|Number of Subjects With Greater Than Grade 2 Toxicity|||participants|||Number
1461279|NCT00770120|Secondary|Overall Survival|Overall survival was defined as the duration between the date of enrollment and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Every 8 weeks until disease progression, up to 3 years.||||months||95% Confidence Interval|Median
1461280|NCT00770120|Secondary|Response|A response was defined as either a confirmed or unconfirmed complete or partial responses as defined by RECIST. A complete response (CR) was defined as the disappearance of all disease. A partial response (PR) was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was considered confirmed if two consecutive determinations were made at least 4 weeks apart.|Every 8 weeks until disease progression, up to 3 years.||||percentage of overall response rate||95% Confidence Interval|Number
1461281|NCT00770120|Primary|Progression-Free Survival|Progression-Free Survival was defined as the duration from the date of registration until the date of disease progression per RECIST or death due to any cause. Patients known to be alive without evidence of disease progression were censored at the date of last contact. Disease progression was defined as a >= 20% increase over nadir in the sum of longest diameters of target lesions, unequivocal progression of non-target lesions in the opinion of the treating investigator, appearance of new lesions, symptomatic deterioration, or death due to disease|Every 8 weeks until disease progression, up to 3 years.||||months||95% Confidence Interval|Median
1461282|NCT00770029|Secondary|1-point Responders at Maximum Frown at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1461283|NCT00770029|Secondary|Responders at Maximum Frown at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1461284|NCT00770029|Secondary|1-point Responders at Rest at Day 30 by Patient’s Assessment on 4-point Scale.|"Patient’s assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out).~A subject was a responder if a 1-point improvement occurred compared to baseline."|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1461285|NCT00770029|Secondary|Responders at Rest at Day 30 by Investigator’s Rating on FWS.|The investigator’s assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.|Baseline to Day 30|The number and percentage of responses by treatment group will be provided for all secondary endpoints on the FAS observed cases.|||Participants|||Number
1461324|NCT00769314|Secondary|Duration of Episode (DOE)|For patients who experienced a vesicular lesion, DOE was defined as the time from treatment initiation to healing of primary and secondary vesicular lesions (loss of crust). For subjects whose primary and secondary lesions were not vesicular in nature, DOE was defied as the time from treatment initiation to return to normal skin or to cessation of symptoms, whichever came last.|Assessed from initiation of treatment to Day 14|This endpoint was analyzed using the ITT population.|||Days||95% Confidence Interval|Median
1461286|NCT00770029|Primary|Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on Facial Wrinkle Scale (FWS) and by Patient’s Assessment on 4-point Scale|"Composite endpoint CETS constituted by two efficacy variables:~The investigator’s assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.~Patient’s assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.~A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables."|Baseline to Day 30|Full Analysis Set (FAS): All randomized subjects treated with study medication. Missing values were imputed by the evaluations made at Day 7 according to the LOCF (last observation carried forward). If no ratings for Day 7 were available values were set to ‘no 2-point responder’.|||Participants|||Number
1461287|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 12||||newtons||Standard Deviation|Mean
1461288|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 8||||newtons||Standard Deviation|Mean
1461289|NCT00769860|Secondary|Maximum Isometric Voluntary Contraction Testing (MVICT) Score|Measured MVICT using the Quantitative Muscle Assessment (QMA) system designed by Computer Source, Atlanta, GA. The system uses an adjustable cuff to attach the patient’s arm or leg to an inelastic strap that is connected to force transducer with a load of 0.5 to 1,000 Newtons. Maximum force is recorded.|Change from Baseline to Month 4||||newtons||Standard Deviation|Mean
1461290|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 12|One of the subjects that dropped from the study in the Arimoclomol arm, returned for the 12 month visit.|||units on a scale||Standard Deviation|Mean
1461291|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 8||||units on a scale||Standard Deviation|Mean
1461292|NCT00769860|Secondary|Inclusion Body Myositis-Functional Rating Scale (IBMFRS) Score|Measured change for the period. The questionnaire has 10 questions. The maximum score is 40. The higher the score the better the functional status of the patient.|Change from Baseline to Month 4||||units on a scale||Standard Deviation|Mean
1461293|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 12||||units on a scale||Standard Deviation|Mean
1461294|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 8||||units on a scale||Standard Deviation|Mean
1461295|NCT00769860|Secondary|Muscle Strength Testing|Change in MMT score for the period. The MMT score range is 0-5. A score of 0 is the lowest and represents no visible or palpable contraction. A score of 5 is the highest and represents full range of motion against gravity, maximal resistance.|Change from Baseline to Month 4||||units on a scale||Standard Deviation|Mean
1461296|NCT00769860|Secondary|Heat Shock Protein 70 (HSP70) Levels in the Tissue|Biopsy taken from participants at baseline and month 4 visits. Measured change in HSP70 levels in the tissue.|Change from Baseline to Month 4||||ng/100ng myosin||Standard Deviation|Mean
1461297|NCT00769860|Primary|Count of Adverse Events Reported|Measure reflects the total number of adverse events reported during course of the study.|Month 12||||adverse events reported|||Number
1461298|NCT00769704|Secondary|Response Interval|Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per Investigator assessment.|||months||95% Confidence Interval|Median
1461299|NCT00769704|Secondary|Time to Treatment Failure|"Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis.~Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point.~Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent to treat population|||months||95% Confidence Interval|Median
1461300|NCT00769704|Secondary|Response Onset|Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.|||months||95% Confidence Interval|Median
1461301|NCT00769704|Secondary|Duration of Response|The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response.|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Participants with an objective response (CR or PR) per EAC assessment.|||months||95% Confidence Interval|Median
1461302|NCT00769704|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points.~Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
1461303|NCT00769704|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained.|From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months.|Intent-to-treat population|||months||95% Confidence Interval|Median
1461304|NCT00769704|Primary|Durable Response Rate|"Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline.~Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.|Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times.|||percentage of participants||95% Confidence Interval|Number
1461305|NCT00769652|Primary|Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
1461306|NCT00769652|Primary|Change in Weight||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
1461307|NCT00769652|Primary|Change in Fat Free Mass (FFM)||3 years|The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.||||||
1461308|NCT00769561|Secondary|TMD Related Symptoms|TMD related symptoms, such as jaw pain, toothache or dizziness, were measured using a 41-item TMD symptom list. Following the SOMS-7 scale, intensity of symptoms experienced during the past week was rated from 0 (‘not at all’) to 4 (‘very high intensity’) (range 0 - 164). A sum score was built with higher scores indicating higher intensity of TMD related symptoms. The TMD symptom list has not been evaluated previously; however, large bivariate correlations with somatization (Pearson’s r = .79), medium to large correlations with pain intensity (r = .48), and medium correlations with depression (r = .37) and anxiety (r = .27) provide evidence of good convergent and divergent validity. Cronbach’s alpha level in the current sample was excellent (α = .93).|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment, and 6-months follow up||||units on a scale||Standard Deviation|Mean
1461309|NCT00769561|Primary|Jaw Use Limitations (JDL)|Jaw use limitations were measured using the Jaw Disability List (JDL) from the RDC/TMD. The JDL asks the patient to rate interference with eleven oral activities, for example chewing or talking. We used an 11-point numeric rating scale (from 0 'no limitation' to 10 'maximum limitation') instead of ratings of ‘yes’ and ‘no’ (range 0 - 110). Higher values indicate higher levels of jaw use limitations. Cronbach's alpha was .86 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1461310|NCT00769561|Secondary|Pain Coping (FESV)|Cognitive and behavioral pain coping strategies were assessed with Coping Strategies Scale from the German Pain Coping Questionnaire (Fragebogen zur Erfassung der Schmerzverarbeitung, FESV). The scale asks for the use of 24 cognitive (e.g. cognitive restructuring) and behavioral (e.g. use of relaxation techniques) strategies for coping with pain on a scale ranging from 1 ('fully disagree') to 6 ('fully agree') (range 24-144). A sum score was used with higher scores indicating more adaptive coping. Cronbach’s alpha level was α = .80.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1461311|NCT00769561|Secondary|General Anxiety Symptoms (GAD-7)|General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 (‘not at all’) to 3 (‘more than half of the days’) rating scale (range 7-21). Higher scores indicate higher levels of anxiety. Cronbach’s alpha level in the current sample was α = .64.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1461348|NCT00769119|Primary|24-hour Sputum Weight(g)|Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||g||Standard Error|Least Squares Mean
1461312|NCT00769561|Secondary|Depressive Symptoms (Centers for Epidemiologic Studies Depression Scale)|Depressive symptoms were measured using the Centre for Epidemiological Studies Depression scale (CES-D). The CES-D asks for the frequency of 20 symptoms of depression during the past week on a scale ranging from 0 (‘less than 1 day’) to 3 (‘5 to 7 days’) (range 0-60). Higher scores indicate more depressive symptoms. It is suitable for use in chronic pain patients as it relies less on physical symptoms of depression than do other measures. Cronbach’s alpha level in the current sample was α = .89.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1461313|NCT00769561|Secondary|Somatoform Symptoms (Screening for Somatoform Disorders, SOMS)|Somatoform complaints during the past week were assessed using the Screening for Somatoform Symptoms (SOMS-7). 32 medically unexplained symptoms (29 for male subjects) representing DSM-IV criteria for somatization disorder were rated on a 0 ('not at all') to 4 ('very much') scale (range 0 - 128 for women and 0 - 116 for men). A sum score was calculated with higher scores indicating higher intensity and burden of somatoform complaints. In the current sample, Cronbach’s alpha level was α = .88.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up||||units on a scale||Standard Deviation|Mean
1461314|NCT00769561|Primary|Pain Disability (Pain Disability Index)|Pain related disability was assessed using the Pain Disability Index (PDI). The PDI is a brief self-rating scale which assesses the level of pain related disability in seven areas of daily life (e.g., social activity, self-care) on a 0 (no disability) -10 (maximum disability) numeric rating scale (range 0 - 70). Higher values indicate higher disability levels. Cronbach's alpha was .87 in the current sample.|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1461315|NCT00769561|Primary|Pain Intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD))|"Characteristic pain intensity (German Pain Questionnaire; Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)):~Characteristic pain intensity was calculated by averaging ratings of current pain, average pain, and worst pain in the past month on a numeric rating scale from 0 (no pain) to 10 (maximum pain), as recommended by RDC/TMD (range 0 - 10). Higher values indicate higher pain levels."|Pre-Post-Design including 3 assessment points: pre-treatment, post-treatment (after 8 weeks), and 6-month follow up|Intent-to-treat approach (ITT) with the last observation carried forward (LOCF)|||units on a scale||Standard Deviation|Mean
1461316|NCT00769314|Secondary|Patient Assessment of Efficacy of the Treatment|At the end of study (Day 14 [ or within 24 hours of healing]), patients were asked to rate efficacy of treatment using a 4-point scale (inactive, mildly active, moderately active, or very active).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.|||participants|||Number
1461317|NCT00769314|Secondary|Patient Satisfaction With Treatment|At the end of study (Day 14 [or within 24 hours of healing]), patients were asked whether they were satisfied with treatment (yes/no).|Assessed on Day 14 (or within 24 hours of healing)|This endpoint was analyzed using the ITT population.|||participants|||Number
1461318|NCT00769314|Secondary|Symptom Intensity (Visual Analogue Scale [VAS])|"Patients were asked to place a tick mark on a 10 centimeter VAS indicating their symptom intensity. Scale ratings ranged from a minimum of 0 (none at all) to a maximum of 10 (worst possible). The location of the tick mark from 0 was measured in millimeters (0 - 100) and recorded."|Assessed on Days 1, 3, 5, 7 and 14 (or within 24 hours of healing)|This endpoint was analyzed using the safety population, which consisted of all randomized patients who took at least 1 dose of study medication.|||units on a scale (0 - 100)||Standard Deviation|Mean
1461319|NCT00769314|Secondary|Patient Incidence of Recurrence of Non-aborted Lesions During 9-month Follow-up|Recurrence was the occurrence of new lesions and was evaluated in a subgroup of patients who agreed to record recurrences during the 9-month follow-up period.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.|||participants|||Number
1461320|NCT00769314|Secondary|Time to Recurrence of Non-aborted Lesions During 9-month Follow-up|Time to recurrence was the time from the healing of all lesions of the initial episode to the occurrence of new lesions.|From time of initial healing through the 9-month follow-up|This endpoint was analyzed using the follow-up population, a subgroup of the ITT population who continued to the 9 month follow-up and had at least 1 diary assessment during that period. The follow-up population was defined as patients whose lesions were healed at the end of Day 14 and had no recurrence within 15 days of healing of all lesions.|||Days||95% Confidence Interval|Median
1461321|NCT00769314|Primary|Time to Healing (TTH) of Vesicular Primary Lesion|Healing was defined as the loss of crust (erythema may be present) as assessed by the investigator. TTH was the time from treatment initiation to healing as defined above and was assessed from the time of treatment initiation through Day 14. The primary vesicular lesion was the first developed lesion located on the lip and was not to have extended more than 1 cm outside the lip.|Assessed from time of treatment initiation through Day 14|The modified Intent-to-Treat (mITT) population was the population used for analysis of this endpoint. The mITT population included all randomized patients who received at least one dose of study medication and who reached the vesicular stage (ie, episodes that progressed through macula, papule, vesicle, crust and healing).|||Days||95% Confidence Interval|Median
1461322|NCT00769314|Secondary|TTH of Aborted Primary Lesions|TTH of aborted primary lesions was defined as the time from treatment initiation to healing of the primary lesion (erythema or papule) or cessation of symptoms, whichever came last. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the subgroup of patients within the ITT population with aborted lesions.|||Days||95% Confidence Interval|Median
1461323|NCT00769314|Secondary|Time to Cessation of Symptoms|Time to cessation of symptoms was defined as the time from treatment initiation to cessation of all symptoms: pain, burning, itching, tingling, tenderness and discomfort. It was to be assessed by the investigator.|Assessed from time of treatment initiation through Day 14|This endpoint was analyzed using the ITT population.|||Days||95% Confidence Interval|Median
1461325|NCT00769314|Secondary|TTH of Non-primary Lesions (Aborted Lesions Excluded)|TTH of non-primary lesions was defined as the time from treatment initiation to healing of all non-primary vesicular lesions. Non-primary lesions were those that developed in addition to and/or in 1 or more days after the primary vesicular lesion and that were located at least 1 cm from the primary lesion. Aborted lesions were not included in this parameter. TTH was to be assessed by the investigator.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using a subgroup of patients in the ITT population with non-primary lesions.|||Days||95% Confidence Interval|Median
1461326|NCT00769314|Secondary|Abortion of Primary Lesions|Aborted lesions were defined as herpetic lesions preceded by prodromal symptoms that did not progress beyond the papule stage.|Assessed from the time of treatment initiation through Day 14|This endpoint was analyzed using the Intent-to-Treat (ITT) population, which consisted of all randomized patients who received at least one dose of study medication and who had complete information recorded for the application time.|||participants|||Number
1461327|NCT00769184|Secondary|Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions|Mean percent improvement in disease severity using Physician Global Assessment (PGA) [PGA scale: Clear (0) - Very Severe (5)] and overall severity scores of target lesions (OTLS) [OTLS scale None (0) - Very Severe (4)] based on erythema, scaling and induration, at each visit interval.|Weeks 2, 6, & 12|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.|||Mean Percent Improvement||Full Range|Mean
1461328|NCT00769184|Primary|Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.|Those patients that have reached a PGA score of zero [PGA scale: clear (0) - very severe (5)], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.|Weeks 2, 6, & 12.|All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.|||percentage of participants|||Number
1461329|NCT00769132|Secondary|Prostaglandin I Metabolite (PGI-M)|The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
1461330|NCT00769132|Primary|Urinary 11-dehydrothromboxane B2 (11-dTxB2)|The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.|On Day 7 across the 24-hour urinary collection period.|Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons.|||pg/mg creatinine||95% Confidence Interval|Least Squares Mean
1461331|NCT00769119|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461332|NCT00769119|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461333|NCT00769119|Secondary|Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461334|NCT00769119|Secondary|Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461335|NCT00769119|Secondary|Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461336|NCT00769119|Secondary|Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461337|NCT00769119|Secondary|Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461338|NCT00769119|Secondary|Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461339|NCT00769119|Secondary|Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461340|NCT00769119|Primary|St George’s Respiratory Questionnaire for COPD Patients (SGRQ-C)|SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Scores on a scale||Standard Error|Least Squares Mean
1461341|NCT00769119|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||events|||Number
1461342|NCT00769119|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1461343|NCT00769119|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1461344|NCT00769119|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/s||Standard Error|Least Squares Mean
1461345|NCT00769119|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1461346|NCT00769119|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1461347|NCT00769119|Primary|Slow Vital Capacity (SVC)|Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1461384|NCT00768989|Secondary|Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Full Range|Geometric Mean
1461349|NCT00769119|Primary|Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461350|NCT00769119|Primary|Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits|End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1461351|NCT00769067|Secondary|Overall Survival (OS)|Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7.|Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||weeks||95% Confidence Interval|Median
1461352|NCT00769067|Secondary|Duration of Response (DR)|Time in weeks from first documentation of objective tumor response to objective tumor progression or symptomatic deterioration or death due to any cause, whichever occurred first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or symptomatic deterioration or death due to any cause or last known progression-free date [if none of the event dates available] minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Analysis population included sub-set of participants from ITT population who had a confirmed objective tumor response (CR or PR).|||weeks||95% Confidence Interval|Median
1461353|NCT00769067|Secondary|Best Overall Response (BOR)|Number of participants with BOR according to RECIST version 1.0: CR= disappearance of all target and non-target lesions. PR= at least 30% decrease in sum of LDs of target lesion, taking as reference baseline sum LD. Stable/no response= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LDs since treatment started. Objective progression= at least a 20% increase in sum of LDs of target lesions, taking as reference the smallest sum of LDs recorded since treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||participants|||Number
1461354|NCT00769067|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of the LDs of target lesion, taking as reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||percentage of participants||95% Confidence Interval|Number
1461355|NCT00769067|Primary|Progression-Free Survival (PFS)|PFS: Time in weeks from randomization to date of objective disease progression or death due to any cause, whichever occurred first. PFS was calculated as (first event date or last known event-free date [if the event date unavailable] minus the date of randomization plus 1) divided by 7. Objective progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LDs) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks|Intent-to-treat (ITT) population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received.|||weeks||95% Confidence Interval|Median
1461356|NCT00769067|Other Pre-specified|Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)|Only participants from “Dacomitinib” treatment arm were planned to be analyzed for this outcome.|C1D10-14, C2D1, C3D1, C4D1|Pharmacokinetic (PK) analysis population: all participants who received >=1 dose of study medication, with treatment assignments designated according to actual study treatment received, and from whom at least 1 PK sample was obtained. Here “n” signifies participants who were evaluable at specified time-point.|||ng/mL||Standard Deviation|Mean
1461357|NCT00769067|Other Pre-specified|Soluble Protein Biomarkers Level|Blood specimens were analyzed at a sponsor-designated laboratory for analysis of shed proteins/receptors related to Human Epidermal Growth Factor Receptor (HER) signaling (EGFR, HER-2, Epithelial-cadherin [E-cadherin]). The data collection after C12D1 was not performed, as there were too few participants across both treatment arms after C12D1.|Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)|Biomarker analysis population: participants who received >=1 dose and had baseline samples submitted as per Institutional Review Board/Independent Ethics Committee approval and participant consent. “N”(number of participants analyzed): participants evaluable for this measure; “n”: participants evaluable at each time-point for each arm respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
1461358|NCT00769067|Other Pre-specified|Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation|Tumor tissue were analyzed at a sponsor-designated laboratory to investigate KRAS and EGFR status (wild type or mutated). Participants who did not provide samples for central laboratory analysis confirmation were classified as “unknown”. Additionally blood specimens were analyzed at a sponsor-designated laboratory for T790M mutation in EGFR.|Baseline|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. The participants under the category EGFR T790M Mutation are already included in the EGFR Mutant category.|||participants|||Number
1461359|NCT00769067|Secondary|Dermatology Life Quality Index (DLQI)|DLQI: 10-item questionnaire to measure how much the participant’s skin problem has impacted their life over the previous week on following 6 domains: symptoms/feelings (2 questions), daily activities (2 questions), leisure (2 questions), work/school (1 question), personal relationships (2 questions), and treatment (1 question). All questions were answered on a 4-point Likert scale ranging from 0 (not at all/not relevant) to 3 (very much/prevented work or studying). The DLQI total evaluable score was calculated by summing the score of each question and ranged from 0 to 30, where higher scores indicated more quality of life impairment.|Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44|ITT population included all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. Here “N” (number of participants analyzed) signifies participants evaluable for this measure; “n” signifies participants evaluable for specified category for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1461360|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Scores averaged, transformed to 0-100 scale; higher symptom score = greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline <=-10), Worsened (if average scales change from baseline >=10), and Stable (if average scales change from baseline >-10 but <10) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.|||participants|||Number
1461361|NCT00769067|Secondary|Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30: included global health status/quality of life (QoL), functional (Fn) scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Scores were averaged, transformed to 0-100 scale; higher score for Global Qol/Fn scales=better level of QoL/functioning or higher score for symptom scales/items=greater degree of symptoms. Overall scale change is categorized as Improved (if average scales change from baseline: for Global QoL/Fn scales >=10; for symptom scale/item <=-10), Worsened (if average scales change from baseline: for Global QoL/Fn scales <=-10; for symptom scale/item >=10), and Stable (if average scales change from baseline >-10 but <10 for Global QoL/Fn scales and symptom scale/item) and participants in each category are reported.|Baseline up to Cycle 44 (Week 188)|ITT population: all randomized participants with study drug assignment designated according to initial randomization, regardless of treatment received. “N” (number of participants analyzed): participants who completed at least 1 item at baseline. “n”: participants evaluable for specified category for each arm, respectively.|||participants|||Number
1461362|NCT00769015|Secondary|Quality of Life: Social Function|Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1461363|NCT00769015|Secondary|Quality of Life: Role Functioning|Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1461364|NCT00769015|Secondary|Quality of Life: Mental Health|Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1461365|NCT00769015|Secondary|Vision Function: Near Activities|Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1461366|NCT00769015|Secondary|Quality of Life: Dependency|Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1461367|NCT00769015|Secondary|Vision Function: Distance Activities|Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.|4 months||||units on a scale||95% Confidence Interval|Least Squares Mean
1461368|NCT00769015|Primary|Depression|The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.|4 months||||participants|||Number
1461369|NCT00768989|Secondary|Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4|AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1461370|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)|Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: <LLN-30; Gr 2: <30-20; Gr 3&4: <20.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1461371|NCT00768989|Secondary|Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4|Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1–10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1461372|NCT00768989|Secondary|Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants|ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN.|While on treatment from Baseline through Week 96|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1461373|NCT00768989|Secondary|Raltegravir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Standard Deviation|Mean
1461374|NCT00768989|Secondary|Atazanavir Terminal Elimination Half Life||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Standard Deviation|Mean
1461375|NCT00768989|Secondary|Atazanavir Individual Inhibitory Quotient (IQ)|Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Units on a Scale||Full Range|Geometric Mean
1461376|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval|AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1461377|NCT00768989|Secondary|Raltegravir AUC (0-12h) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1461378|NCT00768989|Secondary|Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1461379|NCT00768989|Secondary|Raltegravir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1461380|NCT00768989|Secondary|Atazanavir Cmin Prior to the Morning Dose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng*h / mL||Standard Deviation|Geometric Mean
1461381|NCT00768989|Secondary|Raltegravir Cmin 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1461382|NCT00768989|Secondary|Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose||At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||ng•h/mL||Standard Deviation|Geometric Mean
1461383|NCT00768989|Secondary|Raltegravir Tmax|Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.|At Week 2 from Baseline|All randomized participants who received at least 1 dose of study medication and who were evaluable.|||Hours||Full Range|Geometric Mean
1509610|NCT00402194|Primary|Leg Blood Flow Response to Insulin||3 months||||Liters/minute||Standard Deviation|Mean
1461389|NCT00768989|Secondary|Baseline and Mean Change From Baseline in Total Cholesterol Levels|The mean change from baseline in participant fasting lipids was determined using fasting serum samples.|From Baseline to Week 24 and Week 48|All randomized participants who received at least 1 dose of study medication. N=number of participants analyzed; n=number of participants with measurements for that time point.|||mg/dL||Standard Error|Mean
1461390|NCT00768989|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.|Week 1 to Week 96, continuously|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1461391|NCT00768989|Secondary|Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count||From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results.|||cells/mm^3||Standard Error|Mean
1461392|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96||At Week 96 from Baseline|This analysis was not preformed due to early termination of the study.|||Participants|||Number
1461393|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48||At Week 48 from Baseline|The study terminated early, and this analysis was only done at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.|||Participants|||Number
1461394|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24|NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1461395|NCT00768989|Secondary|Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96|Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases.|At Weeks 48 and 96 from Baseline|The study terminated early, and this analysis was done only at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated.|||Participants|||Number
1461396|NCT00768989|Secondary|Number of Nonresponders at Week 8|Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.|At Week 8 from Baseline|The first 60 participants randomized, who received at least 1 dose of study medication.|||Participants|||Number
1461397|NCT00768989|Primary|Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24|The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC).|At Week 24 from Baseline|All randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1461398|NCT00768898|Primary|Conjunctival Staining at 5 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|5 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1461399|NCT00768898|Primary|Conjunctival Staining at 4 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|4 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1461400|NCT00768898|Primary|Conjunctival Staining at 3 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|3 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1461401|NCT00768898|Primary|Conjunctival Staining at 2 Minutes|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|2 minutes after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1461402|NCT00768898|Primary|Conjunctival Staining at 1 Minute|"Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the study eye. The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit."|1 minute after instillation|Analysis conducted per protocol. All subjects participated in each arm/group.|||Units on a scale||Standard Deviation|Mean
1461403|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score|Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||units on a scale||95% Confidence Interval|Mean
1461404|NCT00768755|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score|Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome.|Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)|FA population; ‘N’ (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ is number of participants analyzed at specific time point for each treatment arm respectively.|||units on a scale||95% Confidence Interval|Mean
1461405|NCT00768755|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Subgroup of participants from the FA population with a confirmed objective tumor response (CR or PR).|||months||95% Confidence Interval|Median
1461406|NCT00768755|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions.|Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
1461407|NCT00768755|Secondary|Overall Survival (OS)|Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant|FA population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1461408|NCT00768755|Primary|Progression-Free Survival (PFS)|"Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was Death) or from the end of study data."|Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks|Full analysis (FA) population, included all participants randomized with study medication assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
1461409|NCT00768651|Secondary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|After the 3 month washout period|||||||
1461410|NCT00768651|Secondary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring Blood Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period|||||||
1461411|NCT00768651|Secondary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|3 months - washout period|||||||
1461412|NCT00768651|Secondary|C-peptide Plasma Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) at the End of the 3 Month Washout Period.|Measuring of C-peptide before and 90 minutes after a Mixed Meal Tolerance Test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function. Ther|After the 3 month washout period|||||||
1461413|NCT00768651|Secondary|HbA1c Plasma Laboratory Value for Participants After the 3 Month Washout Period|Measuring of HbA1c using method (manufacturer) at baseline, and months: 1, 3, 6, 9.|After the 3 month washout period|||||||
1461414|NCT00768651|Secondary|Acute Insulin Response to Arginine After the 3 Month Washout Period|An intravenous Arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function. The Arginine is a proxy for insulin secretory reserve (Robertson:2004br)(Rickels:2007cg) and correlates with islet mass in the context of islet allo-transplant (Ryan:2002cg), auto-transplant (Teuscher:1998eu) and hemipancreatectomy (Seaquist:1992iv). An increase in Arginine (AIRarg) would have suggested an increase in beta cell mass.|3 months - washout period|||||||
1461415|NCT00768651|Primary|Weight Change From Baseline After 6 Months of Therapy|Measuring the weight change from baseline at months: 1, 3, 6 and 9.|6 months|||||||
1461416|NCT00768651|Primary|Blood Glucose Laboratory Value Before Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy||6 months|||||||
1461417|NCT00768651|Primary|Glucose Laboratory Value at 90 Minutes After Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy.|Measuring Glucose before and 90 minutes after Mixed Meal Tolerance Test (MMTT) [Ryan: 2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
1461418|NCT00768651|Primary|C-peptide Laboratory Value Before a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
1461419|NCT00768651|Primary|C-peptide Laboratory Value at 90 Minutes After a Mixed Meal Tolerance Test (MMTT) After 6 Months of Therapy|Measuring of C-peptide before and 90 minutes after a mixed meal tolerance test (MMTT) [Ryan:2005ts] at baseline, 6 and 9 months to assess Graft function.|6 months|||||||
1461420|NCT00768651|Primary|Acute Insulin Responses to Arginine After 6 Months of Therapy|An intravenous arginine stimulation test (AST) [Ryan:2002cg] was performed at baseline, 6, and 9 months to assess Graft function.|6 months|||||||
1461421|NCT00768651|Primary|HbA1c Plasma Laboratory Value for Participants After 6 Months of Therapy|HbA1c was measured at baseline, 3, 6, and 9 months using method (manufacturer.|6 months|||||||
1461422|NCT00768651|Primary|Change From Baseline on Gastrin Level After One Month of Therapy|Gastrin levels were measured at baseline and at one month by method (manufacturer).|Baseline and One month|||||||
1461423|NCT00768651|Primary|Change From Baseline of GLP-1 Level After One Month of Therapy|Fasting Glucagon-Like Peptide (GLP-1) levels were measured at baseline and one month. Blood samples were collected in p700 vacutainers (Becton Dickinson, Franklin Lakes, NJ) containing a Dipeptidyl peptidase-4 (DPP4) protease inhibitor cocktail to measure total and active GLP-1 in duplicate using a commercially available ELISA (kit manufacturer) and expressed as the ratio of active:total GLP-1.|Baseline and One month|||||||
1461424|NCT00768651|Primary|Mean Daily Insulin Use (U/Day) After 6 Months of Therapy|Mean daily insulin use was calculated from the three days prior to study visits and performed at baseline, 3, 6, and 9 months.|6 months|||||||
1461425|NCT00768651|Primary|Number of Participants With Fasting Plasma Glucose (FPG) < 7 mmol/l After 6 Months of Therapy||6 months|||||||
1461426|NCT00768651|Primary|Number of Participants With HbA1c < 6.0 % After 6 Months of Therapy|HbA1c was measured using method (manufacturer) at baseline, 3, 6 and 9 months.|6 months|||||||
1461427|NCT00768651|Primary|Number of Participants Not Using Insulin for at Least One Week After 6 Months of Therapy||6 months|||||||
1461428|NCT00768651|Secondary|Insulin Dose (U/Day)||After the 3 month washout period|||||||
1461429|NCT00768651|Secondary|Insulin Independence After the 3 Month Washout Period|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|After the 3 month washout period|Per Protocol Set of participants; The subset of participants in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary and secondary variables.|||% of insulin indipendent participants|||Number
1461430|NCT00768651|Primary|The Primary Endpoint Will be Insulin Independence After 6 Months of Therapy.|Insulin independence was defined as no insulin use for at least one week, HbA1c < 6.0%, fasting plasma glucose < 7.0 mmol/l, fasting or stimulated c-peptide ≥ 0.5 ng/ml. In addition capillary blood glucose levels could not be >7.8 mmol/l (fasting) or > 10 mmol/l (post-prandial) on more than three occasions in the preceding week. Mean daily insulin use was calculated from the three days prior to study visits. Blinded continuous glucose monitoring (CGM) was performed using the iPro device and Carelink software (Medtronic, Mississauga, ON, CA).|6 months|Per Protocol Set of participants: The participants of subjects in full analysis set who were: compliant with the protocol, compliant with pre-specified exposure to the treatment regimen, and available for measurements of primary variables.|||proportion of participants||95% Confidence Interval|Number
1461431|NCT00768599|Secondary|Mycological Cure: Mocassin Disease|Negative KOH and negative fungal culture at Day 43|43|MITT|||Participants|||Number
1461432|NCT00768599|Secondary|Mycological Cure: Interdigital Disease|Negative KOH and negative fungal culture at Day 43|43|MITT|||Participants|||Number
1461433|NCT00768599|Secondary|Effective Treatment: Mocassin Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT|||Participants|||Number
1461434|NCT00768599|Primary|Complete Cure Rate: Moccasin Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|43 Days|MITT|||Participants|||Number
1461435|NCT00768599|Secondary|Effective Treatment: Interdigital Disease|Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).|43|MITT|||Participants|||Number
1461436|NCT00768599|Primary|Complete Cure Rate: Interdigital Disease|A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.|Day 43|MITT|||Participants|||Number
1465561|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 54||Baseline and week 54|Treated Set with values for HbA1c at baseline and week 54. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1461437|NCT00768560|Secondary|Target Blood Pressure Achievement in All Subjects|Subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg. Subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg. Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg.|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1461438|NCT00768560|Secondary|Target Blood Pressure Achievement in Subjects With Diabetes Mellitus or Chronic Renal Disorder|Subjects with diabetes mellitus or chronic renal disorders and target BP SBP <130 mm Hg and DBP <80 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1461439|NCT00768560|Secondary|Target Blood Pressure Achievement in Non-elderly (<65)|Non-elderly subjects (<65 years) without diabetes mellitus or chronic renal disorder and target BP SBP <130 mm Hg and DBP <85 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1461440|NCT00768560|Secondary|Target Blood Pressure Achievement in Elderly (≥65)|Elderly subjects (≥65 years) without diabetes mellitus or chronic renal disorders and target BP SBP <140 mm Hg and DBP <90 mm Hg|After 2 weeks treatment|Subjects valid for efficacy analysis|||participants|||Number
1461441|NCT00768560|Secondary|Differences of Diastolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis|||mm Hg||Standard Deviation|Mean
1461442|NCT00768560|Secondary|Differences of Systolic Blood Pressure Profile|Differences in blood pressure at the same time points (0, 2, 4, 6, 8, 10, 12, 24-hour post-dose) between 2 different days (ie, end of baseline treatment period and end of 2-week treatment period)|Baseline and after 2 weeks treatment|Subjects valid for efficacy analysis|||mm Hg||Standard Deviation|Mean
1461443|NCT00768560|Primary|Change of Sitting Blood Pressure|Changes of sitting SBP and DBP (trough values) from baseline (ie [trough BP at the end of each period during the double-blind treatment period] minus [trough BP at the end of the baseline treatment period])|Baseline and after 2 weeks treatment|Per-protocol efficacy population: subjects valid for safety analysis who have no critical protocol deviation and have trough BP at the end of baseline treatment period and trough BP at the end of period 1 are considered valid for the analysis.|||mm Hg||Standard Error|Least Squares Mean
1461444|NCT00768521|Secondary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 1|All patients|||Percentage change||90% Confidence Interval|Least Squares Mean
1461445|NCT00768521|Primary|Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo|Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)|4 hours post dose 7|All patients|||Percentage change||90% Confidence Interval|Least Squares Mean
1461446|NCT00768430|Primary|MADRS|Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression.|24 hours post-infusion||||units on a scale||95% Confidence Interval|Mean
1461447|NCT00768300|Secondary|Percentage of Participants Who Developed PH on Study|The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.|Up to 48 weeks|Participants in the Full Analysis Set without PH at baseline were analyzed.|||percentage of participants|||Number
1461448|NCT00768300|Secondary|Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)|The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
1461449|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George’s Respiratory Questionnaire (SGRQ)|The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
1461450|NCT00768300|Secondary|Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||units on a scale||Standard Deviation|Mean
1461451|NCT00768300|Secondary|Change in 6MWT at Week 48|The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||meters||Standard Deviation|Mean
1461452|NCT00768300|Secondary|Change in DLCO % Predicted at Week 48|DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||percent change in DLCO % predicted||Standard Deviation|Mean
1461453|NCT00768300|Secondary|Change in FVC % Predicted at Week 48|FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.|Baseline and Week 48|Participants in the Full Analysis Set with evaluable change data were analyzed.|||percent change in FVC % predicted||Standard Deviation|Mean
1491923|NCT00533949|Secondary|Quality-adjusted Survival Based on EuroQoL (EQ5D)-Derived Health Utility Score||From start of treatment to 24 months.||2018-08-31|08/2018||||
1461454|NCT00768300|Secondary|Proportion of Participants With No Disease Progression or Death at 48 Weeks|The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.|Baseline and Week 48|Full Analysis Set|||percentage of participants|||Number
1461455|NCT00768300|Primary|Time to Death or Disease (IPF) Progression.|"The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:~Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days~Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan~All-cause mortality"|Up to 48 months|Full Analysis Set: participants who were randomized and treated|||weeks||Inter-Quartile Range|Median
1461456|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 90|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461457|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 30|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461458|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 12|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461459|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 7|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461460|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 5|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461461|NCT00768222|Secondary|Mean Surgical Site Infection Score on Modified ASEPSIS Scale|Post-operative assessment of wound by trained observer to identify SSI based on several characteristics that are assigned points that contribute to a total score, with 0-10 representing satisfactory healing (best), 11-20 representing disturbance of healing, 21-30 representing minor wound infection, 31-40 representing moderate wound infection, and over 40 representing severe wound infection (worst)|Day 3|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461462|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|30 days|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461463|NCT00768222|Secondary|Mean Cosmetic Outcome Score on Modified Hollander Scale|Post-operative cosmetic outcome assessed on surgical site by investigator using the modified Hollander Cosmetic Scale (mHCS) with 0 representing worst and 6 representing best, calculated by adding the individual scores on each of 6 categories (step-off borders, contour irregularities, wound margin separation, edge inversion, excessive inflammation, and overall appearance|12 days|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461464|NCT00768222|Primary|Mean Score on Cosmetic Outcome Visual Analog Scale (VAS)|Post-operative cosmetic outcome assessed on surgical site photographs by an independent blinded central assessor using a validated 100 mm visual analog scale, with 0 representing the worst possible scar and 100 representing the best possible scar|30 days (+/- 5) post-operative|Intention to treat (ITT)|||score on scale||Standard Deviation|Mean
1461465|NCT00768144|Secondary|Progression-Free Survival|Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.|||weeks||95% Confidence Interval|Median
1461510|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Creatinine|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Micromole/Liter||Standard Error|Least Squares Mean
1491924|NCT00533949|Secondary|Patient-reported Swallowing Ability||From start of treatment to 24 months.||2018-08-31|08/2018||||
1461466|NCT00768144|Secondary|16-Week Progression-Free Survival|16-week progression-free survival is the probability of patients remaining alive and progression-free at 16-weeks from study entry estimated using Kaplan-Meier methods. Patients alive and progression-free at last follow-up are censored. Progressive disease (PD) based on RECIST 1.0 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.|The analysis dataset is comprised of all treated patients.|||probability||95% Confidence Interval|Number
1461467|NCT00768144|Primary|Overall Response Rate|Best response on treatment was based on RECIST 1.0 criteria with overall response defined as achieving partial response (PR) or complete response (CR). Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.|The analysis dataset is comprised of all treated patients.|||proportion of participants||90% Confidence Interval|Number
1461468|NCT00768118|Primary|The Magnitude of Change in Blood Lymphocyte NF-kB Level|The target accrual goal is 15 subjects. It is hoped that of those 15, at least 10 will be intervention compliant, and provide both planned blood samples. NF-kB levels will be measured using a supershift assay, which tests the specificity and level of NF-kB in the sample by measuring the optical density of a scan. With 10 patients, the mean difference in blood lymphocyte NF-kB level could be estimated to within 0.44 standard 7 deviations, with 80% confidence. That is reasonable precision and confidence level for a small pilot study, and should provide sufficiently precise estimates for use in planning a subsequent study.|15 days||||Optical Density unit||90% Confidence Interval|Mean
1461469|NCT00768066|Secondary|Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 Months post-catheterization||||percent change||95% Confidence Interval|Mean
1461470|NCT00768066|Secondary|Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.|Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.|12 months post-catheterization||||units on a scale||95% Confidence Interval|Mean
1461471|NCT00768066|Secondary|Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).|Data provided are with respect to the change from baseline at 12-months post-catheterization.|12 months post-catheterization||||meters||95% Confidence Interval|Mean
1461472|NCT00768066|Secondary|Number of Deaths||12-months post-catheterization||||participants|||Number
1461473|NCT00768066|Secondary|Ectopic Tissue Formation.||12 months post-catheterization||||participants|||Number
1461474|NCT00768066|Secondary|Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.||12 months post-catheterization||||participants|||Number
1461475|NCT00768066|Secondary|Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization||||ng/mL||95% Confidence Interval|Mean
1461476|NCT00768066|Secondary|Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).||Measured every 12 hours for the first 48 hours post-catheterization||||ng/mL||95% Confidence Interval|Mean
1461477|NCT00768066|Primary|Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation||one month post-catheterization||||participants|||Number
1461478|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 90 Response at Week 12|American College of Rheumatology 90% (ACR90) response: responder = ≥90% improvement in tender and swollen joint count and ≥90% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461479|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Week 12|American College of Rheumatology 70% (ACR70) response: responder = ≥70% improvement in tender and swollen joint count and ≥70% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461511|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Units/Liter||Standard Error|Least Squares Mean
1461480|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12|American College of Rheumatology 50% (ACR50) response: responder = ≥50% improvement in tender and swollen joint count and ≥50% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461481|NCT00768053|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 12|American College of Rheumatology 20% (ACR20) response: responder = ≥20% improvement in tender and swollen joint count and ≥20% improvement in at least 3 of 5 ACR core measures: patient assessment of pain (scored 1=extreme pain to 6=no pain; score transformed to 0 to 100: higher score indicates less pain), Patient’s Global Assessment and Physician’s Global Assessment of disease activity (assess arthritis activity; both scored 0=none to 10=extreme), Modified Health Assessment Questionnaire (assess amount of difficulty to perform an activity scored 0=no difficulty to 3=unable to do), and ESR.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461482|NCT00768053|Secondary|Time to Achievement of Sustained Low Disease Activity Score (LDAS): DAS28 ≤3.2|Time to sustained LDAS measured as maintenance of low disease activity score beyond Week 12. DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Baseline up to Week 12|All injected subjects population; DAS28 assessed at Week 4 and Week 12; sustained LDAS could only have been observed beyond Week 12. Time to event analysis not possible within study duration.|||participants|||Number
1461483|NCT00768053|Secondary|Percentage of Participants Achieving > 0.6 DAS28 Response at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >0.6 DAS28 response defined as decrease in DAS28 > 0.6 (i.e. change in DAS28 < -0.6).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461484|NCT00768053|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.2) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461485|NCT00768053|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scalescored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission.|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461486|NCT00768053|Secondary|Percentage of Participants Achieving > 1.2 Improvement in DAS28 at Week 12|DAS28 calculated from number of painful and swollen joints using 28 joints count (PJC, SJC), ESR (mm/hour), and patient's global assessment of disease activity (arthritis activity measured on 11-point rating scale scored 0 [none] to 10 [extreme]). DAS28 score calculated as 0.56*square root (√) (PJC28) + 0.28 *√ (SJC28) + 0.70*ln ESR + 0.014*PGA*10. DAS28 score >5.1=higher disease activity; ≤3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (i.e., change in DAS28 < -1.2).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461487|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 12 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 12 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||percentage of participants|||Number
1461488|NCT00768053|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS) Score at Week 4 Who Had an Acceptable Symptom State at Week 4, Week 12, or Last Observation (Last Obs)|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be acceptable or unacceptable to you?). PASS score at Week 4 calculated on participants with Acceptable symptom state achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||percentage of participants|||Number
1461512|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|"All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing.~endpoints."|||Units/Liter||Standard Error|Least Squares Mean
1461489|NCT00768053|Secondary|Patient Acceptable Symptom State (PASS) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|PASS is a 1-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours (If you were to remain in the next few months as you were during the last hours, would this be Acceptable or Unacceptable to you?). PASS score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of their symptom state at observation was Acceptable.|Week 4, Week 12|All injected subjects population. Unacceptable value put to participants prematurely withdrawn or with missing data; (n) includes participants with analyzable data at observation (responses of Acceptable or Unacceptable).|||scores on a scale|||Number
1461490|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement Score at Week 12 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 12 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||percentage of participants|||Number
1461491|NCT00768053|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII) Score at Week 4 Who Had Moderately or Slightly Important Improvement at Week 4, Week 12, or Last Observation (Last Obs)|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). MCII score at Week 4 calculated on participants with Moderately or Slightly important improvement (Mod/Slightly Imp Improvement) achieved at observation.|Week 4, Week 12, and Last observation up to Week 12|All injected subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||percentage of participants|||Number
1461492|NCT00768053|Secondary|Minimal Clinically Important Improvement (MCII) of the EULAR-RAID Score: 75th Percentile of Change at Week 4 and Week 12|MCII is a 2-question assessment of how rheumatoid arthritis has affected the participant in the last 48 hours. Question 1: in comparison to study start (Improved, No Change, or Worse). Question 2: if response was Improved, participant rated how important the improvement was (Very important, Moderately important, Slightly important, or Not important at all). The MCII score is defined as the 75th percentile of the change in EULAR-RAID score between baseline and observation among participants whose evaluation of the response therapy at observation was Moderately or Slightly important improvement.|Week 4, Week 12|All injects subjects population; (n) includes participants with analyzable data at observation (responses of Yes or No).|||scores on a scale|||Number
1461493|NCT00768053|Secondary|Percentage of Participants Achieving a Moderate or Good EULAR Response Rate at Week 12|EULAR response rate is based on DAS28. For DAS28 ≤3.2 at observation (low disease activity), change from baseline of <-1.2=good response or ≥-1.2 to <-0.6=moderate response; DAS28 >3.2 to 5.1 at observation (moderate or high disease activity), change from baseline of <-1.2 or ≥-1.2 to <-0.6=moderate response; DAS28 >5.1 (high disease activity) at observation, change from baseline of <-1.2=moderate response. DAS28 calculated using the 28 joints count, ESR mm/hour, and PGA of disease activity (participant rated arthritis activity measured on 11-point rating scale: 0 [none] to 10 [extreme]).|Week 12|All injected subjects population; N=number of participants with evaluable data at observation.|||percentage of participants|||Number
1461494|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 12|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 12|All injected subjects population|||standardized response mean|||Number
1461495|NCT00768053|Primary|Sensitivity to Change of the EULAR-RAID Score: Change From Baseline to Week 4|Sensitivity to change analyzed by testing if the difference of change from baseline of EULAR-RAID score minus the change from baseline of each component (pain, functional disability, fatigue, sleep disturbance, coping, overall physical and emotional well-being with score range 0 [not affected, very good] to 10 [most affected]) was different from 0 or not. Results expressed as standardized response mean (SRM) calculated as ratio of mean change over standard deviation of the change. A non significant test (p value ≥0.05) means the component had a significant influence to global EULAR RAID score.|Baseline, Week 4|All injected subjects population|||standardized response mean|||Number
1461496|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.|||correlation coefficient||95% Confidence Interval|Number
1461497|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status: Week 12|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and PGA health status score. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Week 12|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1461498|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Patient Global Assessment (PGA) of Health Status|PGA of health status is a single-item participant rated response to the question “in general, how would you rate your health over the last 2 to 3 weeks”; scored 0 (very well) to 10 (extremely bad). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the PGA. A higher correlation coefficient indicates greater EULAR-RAID score validity (best >0.85).|Baseline, Week 4|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1461499|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Time-normalized Average|Time-normalized average is the area under the curve (AUC) / time between first and last observations. DAS28 calculated from number of swollen joints and painful joints using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID and DAS28 scores. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Last observation up to Week 12|All injected subjects population; score profile from baseline to last observation post-baseline.|||correlation coefficient||95% Confidence Interval|Number
1461500|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28): Week 12|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Week 12|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1461501|NCT00768053|Primary|Face Validity: Correlation Coefficients of the EULAR-RAID Score With the Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity question measured on an 11-point rating scale scored 0 [none] to 10 [extreme]). Face validity assessed using a correlation coefficient between the EULAR-RAID score and the DAS28. A higher correlation coefficient indicates greater EULAR-RAID score validity.|Baseline, Week 4|All injected subjects population|||correlation coefficient||95% Confidence Interval|Number
1461502|NCT00768053|Primary|Simplicity: Time for Completion of the EULAR-RAID Questionnaire|EULAR-RAID is an assessment of patient reported outcomes for pain, functional disability, fatigue, sleep disturbance, coping, overall assessments of physical well-being and emotional well-being based on 7 numerical rating scales (NRS) questions. NRS individual questions with range of 0 (not affected, very good) to 10 (most affected) weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected).|Baseline up to Week 12|All injected subjects population. Data was not summarized; the time to complete the EULAR-RAID questionnaire was not analyzed separately from other components of the EULAR questionnaire (EULAR-RAID, questions on pain, Modified Health Assessment Questionnaire, sleep and coping)|||minutes||Standard Deviation|Mean
1461503|NCT00768053|Primary|Reliability of the European League Against Rheumatism - Rheumatism Arthritis Impact of Disease (EULAR-RAID) Score|EULAR-RAID score reliability assessed using an intraclass correlation coefficient (using a consistency definition where the between-measure variance is excluded from the denominator variance and its 95% confidence interval) and the standard error of measurement (SEM) and its 95% confidence interval (CI). A higher intraclass correlation coefficient (ICC) indicates greater score reliability (0.0 to 0.10=virtually none; 0.11 to 0.40=slight; 0.41 to 0.60=fair; 0.61 to 0.80=moderate; 0.81 to 1.00=substantial).|Screening, baseline|All injected subjects population: received at least 1 dose of study treatment (same as Safety population).|||intraclass correlation coefficient||95% Confidence Interval|Number
1461504|NCT00768040|Primary|Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment|The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor|Baseline to week 12|This study was terminated early due to low recruitment of patients.|||μm||Standard Error|Least Squares Mean
1461505|NCT00767806|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale|The Columbia Suicide Severity Rating Scale (C–SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.|baseline through 12 weeks|All randomized participants.|||participants|||Number
1461506|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Pulse Rate|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||beats per minute||Standard Error|Least Squares Mean
1461507|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Weight|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||kilogram||Standard Error|Least Squares Mean
1461508|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Blood Pressure|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||millimeter mercury||Standard Error|Least Squares Mean
1461509|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Total Protein|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Gram/Liter||Standard Error|Least Squares Mean
1461513|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Units/Liter||Standard Error|Least Squares Mean
1461514|NCT00767806|Secondary|Change From Baseline to 12 Week Endpoint in Albumin|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Gram/Liter||Standard Deviation|Least Squares Mean
1461515|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Uric Acid|Least Squares Mean values were controlled for investigator.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||Micromole/Liter||Standard Error|Least Squares Mean
1461516|NCT00767806|Secondary|Participants Who Discontinued From Baseline to 12 Weeks|Reasons for discontinuation are listed in the participant flow.|baseline, 12 weeks|All randomized participants.|||participants|||Number
1461517|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)|"WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.~Absenteeism~Presenteeism~Work productivity loss~Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment."|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints. Not for all participants were data for all WPAI items available.|||units on a scale||Standard Deviation|Mean
1461518|NCT00767806|Secondary|Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension|Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1461519|NCT00767806|Secondary|Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1461520|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form|The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1461521|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire|Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1461522|NCT00767806|Secondary|Patient's Global Impression of Improvement (PGI-I) at 12 Weeks|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and baseline severity.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1461523|NCT00767806|Secondary|Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1461536|NCT00767520|Secondary|Number of Participants With Abnormalities in Electrocardiograms||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||2013-05-31|05/2013||||
1461537|NCT00767520|Secondary|Number of Participants With Abnormalities in Vital Signs||Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment.||2013-05-31|05/2013||||
1492381|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 4 weeks (measured by spirometry)|4 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1461524|NCT00767806|Secondary|Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution|The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.|12 weeks|All randomized participants with non-missing baseline value; baseline observation carried forward method was used to impute missing endpoints.|||participants|||Number
1461525|NCT00767806|Secondary|Number of Sustained Responders at 12 Week Endpoint|Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
1461526|NCT00767806|Secondary|Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
1461527|NCT00767806|Secondary|Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint|Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.|12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||participants|||Number
1461528|NCT00767806|Secondary|Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Error|Least Squares Mean
1461529|NCT00767806|Secondary|Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value. Last observation carried forward method was used to impute missing endpoints.|||units on a scale||Standard Deviation|Mean
1461530|NCT00767806|Primary|Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score|A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and baseline severity.|baseline, 12 weeks|All randomized participants with baseline and at least 1 non-missing post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1461531|NCT00767767|Primary|GSR Trial 1|Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1)|First Trial, for up to 1 day||||units on a scale||Standard Deviation|Mean
1461532|NCT00767676|Primary|Number of Participants That Exhibited a Score Less Than 1.5 on the Jordan-King Scale|"To qualify for the claim of a reduced sensitization potential, all subjects completing the study could exhibit a value of no more than 1.5 on the Jordan-King Scale [scale is 0 (no visible reaction) to 5 (severe erythema)]~No statistical analyses were performed."|7 weeks|Per protocol|||participants|||Number
1461533|NCT00767624|Secondary|Percentage of Participants in Insomnia Remission|Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.|16 weeks||||percentage of particpants in arm|||Number
1461534|NCT00767624|Primary|Percent of Participants With Depression Remission|"Depression remission was defined if both a and b below are satisfied~absence of both depressed mood and anhedonia for at least three consecutive weeks~no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks"|16 weeks||||percentage of participants in arm|||Number
1461535|NCT00767572|Primary|Pre-post Change in Brachial Artery Reactivity|Brachial artery reactivity was assessed by Flow-mediated dilatation (FMD), performed before and after the 12 week period on therapy. FMD uses high-frequency ultrasound measurement of changes in brachial artery diameter after a 5-minute blood pressure cuff arterial occlusion. Brachial artery reactivity has been shown to predict long-term cardiovascular events.|Baseline, 12 weeks|12 enrolled participants were randomly assigned to receive a 12-week course of either atorvastatin or placebo, followed by a 4-week washout, then 12 weeks on the alternate intervention.|||mm||Standard Deviation|Mean
1461538|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Potassium, Magnesium, Sodium, Phosphorous, Uric Acid, and Bicarbonate (as Per the NCI CTCAE, Version 3.0)|Grade (GR)1= mild, GR2= moderate, GR3= severe, GR4= life threatening. Ranges are provided by the local laboratory and may vary according to sex and age. Phosphorous, GR1:<LLN 2.5 mg/dL, GR2:<2.5–2.0 mg/dL, GR3: 1.0-<2.0 mg/dL; Low sodium,GR1:<LLN 130mmol/L, GR3:120-<130 mmol/L; High Magnesium, GR1 >ULN 3.0 mg/dL,GR 3:<0.3 0.8mg/dL; Uric acid, GR1:>ULN 10 mg/dL, GR4:>10 mg/dL; Low potassium, GR1:<LLN 3.0mmol/L,GR3:<3.0 2.5mmol/L; High potassium, GR1:>ULN–5.5 mmol/L, GR2:>5.5–6.0 mmol/L; Bicarbonate, GR1:<LLN–16 mmol/L; GR2:<16 – 11 mmol/L; Hig sodium, GR1:>ULN–150 mmol/L,GR2:>150–155 mmol/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1461539|NCT00767520|Primary|Participants With Disease Progression or Death for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PD is an increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs. Maximum participant PFS of ____ months)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.|||participants|||Number
1461540|NCT00767520|Secondary|Number of Participants With Grade 1-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Bilirubin, Calcium, Creatinine, and Albumin (as Per the NCI CTCAE, Version 3.0)|Grade (GR) 1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening). Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, GR 1: >ULN–2.5 x ULN (upper limit of normal), GR 2: >2.5–5.0 x ULN, GR 3: 5.0-20.0 x ULN; Low calcium, GR 1: <LLN – 8.0 mg/dL, GR 2: <8.0–7.0 mg/dL, GR 4:<6.0 mg/dL; High calcium, GR 1:>ULN – 11.5 mg/dL; bilirubin, GR 1: >ULN–1.5 x ULN,GR 3: >3-10 x ULN; Creatinine, GR1:>ULN–1.5 x ULN, GR2: >1.5–3.0 x ULN; Albumin, GR1:<LLN–3 g/dL,GR2:<3–2 g/dL.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1461541|NCT00767520|Secondary|Number of Participants With Grade 1-4 Hematology Abnormalities (as Per the NCI CTCAE, Version 3.0)|Abnormalities were graded per NCI-CTC, Version 3.0 criteria. Grade (GR)1 = mild, GR 2 = moderate, GR 3 = severe, GR 4 = life threatening. Normal ranges are provided by the Local Laboratory and may vary according to sex and age. Granulocytes, GR 1;<LLN–1.5x 10^9/L, GR 2:<1.5–1.0x10^9/L, GR 3: <1.0 – 0.5x10^9/L, GR, 4: <0.5x10^9 /L; Hemoglobin, GR 1: <LLN–10.0 g/dL, GR 2: <10.0–8.0 g/dL, GR 3: <8.0–6.5 g/dL, GR, 4: <6.5g/dL; Platelets, GR 1: <LLN–75.0x10^9/L, GR 2: <75.0–50.0x10^9/L, GR 3: <50.0-25.0x10^9/L; Leukocytes, GR 1: <LLN–3.0x10^9/L, GR 2: <3.0–2.0x10^9/L, GR 4: <1.0x10^9/L.|Data was collected prior treatment with the study drug, after week 2, 4, and week 8, every 8 weeks thereafter and at the end of the treatment. Median duration (on-study) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1461542|NCT00767520|Secondary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs (as Per National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 3.0)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade (GR)1 = mild, GR 2 = moderate, GR 3=severe, GR 4=life threatening, GR 5=death.|From start of study drug therapy up to 30 days after the last dose. Median duration of therapy (on-study time) was 14.29 and 15.29 weeks for dasatinib and placebo groups, respectively.|All treated participants.|||participants|||Number
1461543|NCT00767520|Secondary|Changes in Markers of Bone Lysis in Participants With Bone Metastasis|Assay for urinary N-telopeptide was used to evaluate Osteolytic activity.|Screening, Day 1, after week 2, 4, and week 8 and subsequently every 8 weeks, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||2013-05-31|05/2013||||
1461544|NCT00767520|Secondary|Changes in Participant-reported Pain Intensity in Participants With Bone Metastasis|Pain intensity evaluated by administration of the Brief Pain Inventory - Short Form (BPI-sf). The BPI-sf is a psychometrically-validated instrument which measures both pain severity and functional interference caused by pain using an 11-point numerical rating scale. Severity of pain at its “worst”, “least” and “on average” in the last 24 hours, and “right now” (ie, at the time the questionnaire is being filled out) is recorded using anchors of “no pain” = “0” and “pain as bad as you can imagine” = “10”.|Start of study, at treatment start, after 2, 4, and 8 weeks of therapy and every 8 weeks thereafter, at end-of-treatment. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug.||2013-05-31|05/2013||||
1461545|NCT00767520|Secondary|Duration of Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Duration of response is defined as the time from date that measurement criteria are first met for PR or CR until first date of documented PD or death. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer.||2013-05-31|05/2013||||
1461557|NCT00767507|Primary|Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.|Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).|During study drug infusion up to 1-6 hours prior to surgery||||percentage of samples|Participants||Number
1461546|NCT00767520|Secondary|Time to Response for Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Time to response is defined as time from first dose of study therapy until measurement criteria are first met for PR or CR (whichever is recorded first). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until CR or PR. Participants will remain on study (ie, last visit) until disease progression or 30 days after the last dose of study drug, whichever is longer||2013-05-31|05/2013||||
1461547|NCT00767520|Secondary|Participants With Freedom-From-Progression (FFP) at 6 Months|FFP at month 6 is defined for the randomized participants who had the probability of neither progressing nor dying before 6 months.|at 6 months||2013-05-31|05/2013||||
1461548|NCT00767520|Secondary|Percentage of Participants With Response in Exemestane Plus Dasatinib Arm and Exemestane Plus Placebo Arms|Response= Proportion of response-evaluable participants whose best response is CR or PR. Confidence intervals was computed using the Clopper-Pearson method. CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions.|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant response was 39 weeks)|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1461549|NCT00767520|Secondary|Percentage of Participants With Clinical Benefit (CB) for Exemestane Plus Dasatinib Arm vs Exemestane Plus Placebo Arm at 6 Months|CB = participants whose best response is CR, PR, or stable disease(SD). CR = Disappearance of all measurable and non-measurable lesions, and no new lesions; PR = Decrease ≥30% from baseline in sum of longest diameters of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value). Confidence interval computed by Clopper-Pearson method.|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1461550|NCT00767520|Secondary|Number of Participants With Best Overall Response|Complete response (CR) = Disappearance of all measurable and non-measurable lesions, and no new lesions; Partial response (PR) = Decrease ≥30% from baseline in sum of longest diameters (LD) of all measurable lesions, with neither appearance of new lesions nor unequivocal progression of non-measurable lesions. SD = Disease re-assessment not qualifying as CR, PR or PD(≥20% increase in sum of longest diameters from smallest value).|at 6 months|Response-evaluable participants: All treated participants who had measurable disease at baseline and at least one on-study tumor assessment. Treated participants without on-study tumor assessment due to rapid progression or study drug toxicity were included in the response-evaluable population as non-responders.|||participants|||Number
1461551|NCT00767520|Primary|Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo|PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).|Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)|All randomized participants. Participants who died without reporting tumor progression were considered to have progressed on the death date. Participants who neither progressed nor died were censored on the day of their last on-study tumor assessment or the first date of subsequent therapy.|||weeks||95% Confidence Interval|Median
1461552|NCT00767507|Secondary|Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner||Through 7 days or hospital discharge, whichever was sooner||||patients|||Number
1461553|NCT00767507|Secondary|Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild||Randomization until start of CABG surgery|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.|||participants|||Number
1461554|NCT00767507|Secondary|Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding|Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of >1.5 liters (L), and/or packed red blood cell transfusions > 4 units|Randomization through Hospital discharge|This analysis included only those patients who proceeded to have a CABG surgery as required per the protocol. The patients who did not have a CABG surgery were excluded from the denominator.|||Patients|||Number
1461555|NCT00767507|Secondary|Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU|"This endpoint analyzed the percent of patients with platelet reactivity < 240 PRU at the following timepoints:~Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition)~Last sample during infusion~Following discontinuation of study drug infusion"|baseline until just prior to surgery (post infusion)||||percent of patients|||Number
1461556|NCT00767507|Primary|Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.|"This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events.~Patients had multiple samples and all on-infusion samples had to be <240 PRU to meet the endpoint."|During study drug infusion up to 1-6 hours prior to surgery|"Based on available data from ITT population; ITT population (Cangrelor N = 93) / (Placebo N = 90).~Valid PRU results were not available during the infusion period for 15 patients (9 cangrelor and 6 placebo)."|||Percent of patients|||Number
1492382|NCT00530842|Secondary|Slow Vital Capacity (SVC)|Trough SVC (Slow Vital Capacity) after 8 weeks (measured by spirometry)|8 weeks|FAS using imputed values|||Litres||Standard Error|Mean
1461558|NCT00767455|Primary|Presence of Cumulative Irritation|Irritancy of each test article was evaluated by assessment of the application sites using the Berger and Bowman Scale. Observed responses (e.g., erythema and edema) were graded according to the protocol-specified grading scale [0 (no visible reaction) to 4 (severe erythema)] for each subject. The relative cumulative irritation potentials of the test article (HP828-101 Ointment) and the negative and positive controls were determined by summing the daily scores of the 21 days of testing; with an overall scale of 0 (no visible reaction from any subjects over the 21 days) to 3360 (severe erythema experienced by every subject over the 21 days).|22 days|Per protocol|||units on a scale|||Number
1461559|NCT00767364|Secondary|Serum Anti-rotavirus IgA Level Post-vaccination|Serum anti-rotavirus IgA level was measured post-vaccination in all subjects|6 months from the first vaccination date||||U/ml|||Number
1461560|NCT00767364|Primary|Safety and Tolerability of the Oral RotaTeq® Vaccine|Adverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.|12 months from the first vaccination date||||Individual Adverse Events|||Number
1461561|NCT00767338|Primary|Number of Live Births After Eight Cycles of Infertility Treatment.||January 2009 to January 2012|The participants analyzed correspond to the number of participants who completed the study. In two of the arms, the study was terminated before participants were randomized to those arms.|||participants|||Number
1461562|NCT00767325|Secondary|Number of Participants With Adverse Events (AEs) of Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Infusion reaction: acute=1 hour or less after start of dosing; periinfusional=24 hours or less after start of dosing.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.|||Participants|||Number
1461563|NCT00767325|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events(SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Days 1 to 169 to 56 days following last infusion|All participants who received at least 1 infusion of study drug.|||Participants|||Number
1461564|NCT00767325|Secondary|Number of Early (Days 7 to 113) Global PDUS MCP 2-5 Scores or Global PDUS Component MCP 2-5 Scores Associated With an Acceptable Predictability of Clinical Response at Day 169, As Assessed by DAS28-CRP|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography; DAS=Disease Activity Score;CRP=C-reactive protein. Receiver Operator Characteristics (ROC) analysis assessed predicatability. ROC curve analyses performed; area under the curve of ≥0.7 was considered acceptable for prediction. Clinical response defined as: Clinically Meaningful Improvement=drop from baseline of ≥1.2 in DAS28-CRP; Remission=DAS28-CRP score <2.6; Low Disease Activity=≤3.2. PDUS scores: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH with ≤Gr 2 Doppler signal or minimal SH and Gr 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint rated 1-3, for a total possible score ranging from 8-24 (8*1, 8*3)for the 2 hands. Higher gr/score=more severe disease.|Days 1 to 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Scores|||Number
1461565|NCT00767325|Primary|Earliest Time Point at Which Improvement of Core Component of the Global PDUS in the MCP (2-5) Joints of Both Hands Was Assessed|MCP=metacarpophalangeal; PDUS=power Doppler ultrasonography. Time point at which early signs of Global PDUS improvement were observed=earliest time point for which 0 was not included in the 95% confidence interval for the mean changes from baseline in Global PDUS (MCP 2-5) score at that and all later time points. Total PDUS scores are independent of the presence and grade of joint effusion: Grade (Gr) 0 or normal=normal joint (no synovial hypertrophy [SH], no Doppler signal); Gr 1 or minimal=minimal synovitis (minimal SH, with ≤Gr 1 Doppler signal); Gr 2 or moderate=moderate synovitis (moderate SH, with ≤Gr 2 Doppler signal or minimal SH and grade 2 Doppler signal); Gr 3 or severe=severe synovitis (severe SH with ≤Gr 3 Doppler signal or minimal or moderate SH and Gr 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher Gr/score=more severe disease.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Day|||Number
1461566|NCT00767325|Secondary|Mean Change From Baseline in Global PDUS MCP 2-5 Component Scores Over Time (LOCF Analysis)|PDUS=power Doppler ultrasonography; MCP=metacarpophalangeal; LOCF=last observation carried forward. PDUS was used to assess the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and grade 2 Doppler signal); Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤ Grade 3 Doppler signal or minimal or 1-3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for the 2 hands. Higher grade/score=more severe disease. Change=score Day X-baseline score.|Days 7, 15, 29, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Units on a scale||Standard Error|Mean
1461848|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461567|NCT00767325|Primary|Mean Change From Baseline in Global Power Doppler Ultrasonography (PDUS) Score Assessing the Metacarpophalangeal (MCP) 2-5 Joints of Both Hands (LOCF Analysis)|LOCF=last observation carried forward. PDUS assessed the degree of synovial inflammation of the MCP joints (2nd to 5th) of both hands and was performed at approximately the same time of day for each participant. Total PDUS scores are independent of the presence and grade of joint effusion and are evaluated as follows: Grade 0 or normal=normal joint (no synovial hypertrophy, no Doppler signal); Grade 1 or minimal=minimal synovitis (minimal synovial hypertrophy, with ≤Grade 1 Doppler signal); Grade 2 or moderate=moderate synovitis (moderate synovial hypertrophy with ≤Grade 2 Doppler signal or minimal synovial hypertrophy and Grade 2 Doppler signal; Grade 3 or severe=severe synovitis (severe synovial hypertrophy with ≤Grade 3 Doppler signal or minimal or moderate synovial hypertrophy and Grade 3 Doppler signal). Each joint is rated 1 to 3, for a total possible score ranging from 8 to 24 (8*1, 8*3) for 2 hands. Higher grade/score=more severe disease. Change=score Day x - baseline score.|Baseline to Days 7, 15, 29, 43, 57, 85, 113, 141, and 169|All participants who received at least 1 infusion of study drug and who had baseline and at least 1 postbaseline efficacy measurements available. Excludes 8 participants with PDUS values from 1 site that experienced technical and quality issues with PDUS scoring and compliance.|||Units on a scale||95% Confidence Interval|Mean
1461568|NCT00767104|Secondary|% Reduction in Total Lesion Count|.This is a measure of the % reduction in the total number of papules, pustules and cysts at Week 12.|12 weeks||||% reduction in total lesion count||95% Confidence Interval|Mean
1461569|NCT00767104|Primary|Total Lesion Count|The number of papules, pustules and cysts at Week 12.|12 weeks|Number of participants in each group|||lesions||95% Confidence Interval|Mean
1461570|NCT00767039|Secondary|Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.|Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.|NICU hospitalization, up to 42 weeks post menstrual age|All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at > 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.|||Subjects with BPD + Neonatal Deaths||90% Confidence Interval|Number
1461571|NCT00767039|Secondary|Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)|Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.|36 weeks post menstrual age|Population analyzed was limited to those subjects who survived to >36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at >36 weeks post menstrual age) were tallied.|||Surviving Subjects with BPD||90% Confidence Interval|Number
1461572|NCT00767039|Secondary|Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant|Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.|One hour following second surfactant dose at 12-24 hours after initial dose|The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.|||Percent change from baseline velocity||Standard Error|Mean
1461573|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20-Percent of O2||Standard Error|Mean
1461574|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20-Percent of O2||Standard Error|Mean
1461575|NCT00767039|Secondary|Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf)|Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.|First hour after 2nd surfactant dose|Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.|||cc/min||Standard Error|Mean
1461590|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Investigators|Investigator evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1461576|NCT00767039|Secondary|Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)|Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.|Hemodynamically significant PDA at > 2 days|Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at >3 days, were tallied|||Subjects||90% Confidence Interval|Number
1461577|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|72 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.|||Participants successfully extubated||90% Confidence Interval|Number
1461578|NCT00767039|Primary|Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.|72 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20||Standard Error|Mean
1461579|NCT00767039|Secondary|Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups|Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.|48 hours after surfactant administration|Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.|||Participants successfully extubated||90% Confidence Interval|Number
1461580|NCT00767039|Primary|Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.|Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.|48 hours after surfactant administration|Enrolled subjects surviving >/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.|||cm H20||Standard Error|Mean
1461581|NCT00767000|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event||Entire study including 54-week study and 104-week extension||||percentage of participants|||Number
1461582|NCT00767000|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Entire study including 54-week study and 104-week extension|Full analysis set. Includes additional participants enrolled in the MK-0941 40 mg and placebo groups to enhance evaluation of the safety profile of MK-0941.|||percentage of participants|||Number
1461583|NCT00767000|Secondary|Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%||Weeks 54, 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158||||||
1461584|NCT00767000|Secondary|Percentage of Participants Who Achieve an HbA1c of <7.0%||Weeks 106 and 158|Due to early termination and small numbers of participants, no efficacy analyses were performed at Weeks 106 or 158||||||
1461585|NCT00767000|Secondary|Change in the Fasting Plasma Glucose Level|Least squares mean change from baseline in fasting plasma glucose.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1461586|NCT00767000|Secondary|Change in the Two-hour Post Meal Glucose Level|Least squares mean change from baseline in 2-hour post meal glucose level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
1461587|NCT00767000|Primary|Change in Hemoglobin A1c (HbA1c) Level|Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.|Baseline and Weeks 14, 54, 106, and 158|Full analysis set. The additional participants added to the MK-0941 40 mg and placebo arms to enhance evaluation of safety were not included in the analysis.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
1461588|NCT00766831|Secondary|Percentage of Participants With Different Reasons for Their Preference for Oral Long-Action Opioids Analgesic or Study Drug|"Participants reasons for preference between the long acting oral opioid analgesic and the study drug administered were reported. Reasonos for preferences were I experienced a certain pain relief effect during the administration of the drug, I didn’t wake up due to pain while sleeping, It was more convenient because the number of administrations was reduced, I could reduce the administration of short acting narcotic analgesic to treat breakthrough pain and other."|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Percentage of participants|||Number
1461589|NCT00766831|Secondary|Percentage of Participants Who Preferred the Oral Long-Action Opioids Analgesic or Study Drug|Participant's preferences between the oral long-action opioids analgesic and the study drug was reported.|Day 15|ITT population included all the participants who received at least one dose of study medicaation and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.|||Percentage of participants|||Number
1493544|NCT00524225|Secondary|Number of Participants|mild headache, nausea|The time frame is within 4 weeks of surgery.||||participants|||Number
1461591|NCT00766831|Secondary|Number of Participants in Each Category of Global Assessment of Overall Efficacy of Study Drug Assessed by Participants|Participants evaluated overall efficacy of study drug according to the rating of 1=not effective, 2=average, 3=effective, 4=very effective and 5=extremely effective.|Day 15|ITT population included all the participants who received at least one dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1461592|NCT00766831|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-Improvement) Score|The CGI-Improvement score evaluates how much the participant’s condition is improved compared to Baseline. The score ranges from 1 to 7, where 1=improved very much, 2=Improved much, 3=Improved a little, 4=No change, 5=Aggravated a little,6=Aggravated much and 7=aggravated very much.|Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1461593|NCT00766831|Secondary|Number of Participants With Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Score|The ECOG performance status was used to evaluate participant’s disease progression and the effect of the disease on the participant’s activities of daily living. ECOG performance status score ranges from Grade 0 to 4, where Grade 0=Fully active, Grade 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, Grade 2=ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3=capable of only limited self-care, confined to bed or chair, and Grade 4=completely disabled.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1461594|NCT00766831|Secondary|Number of Times the Short-Acting Opioid Analgesic Administered for Breakthrough Pain|The participants recorded the frequency of short acting opioid analgesic taken for treating breakthrough pain among the pains suffered by the participants. Here frequency means number of times the short-acting opioid analgesic administered for breakthrough pain from baseline to Day 15|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'N' signifies participants who were evaluated for this outcome measure.|||Frequency of breakthrough pain drug||Standard Deviation|Mean
1461595|NCT00766831|Secondary|Participant’s Pain Intensity|Participant’s pain intensity was measured using NRS ranging from 0=no pain to 10=unimaginable extreme pain. Participants maintained pain diary for 3 days before Baseline until Day 15 and pain intensity was measured twice daily (morning and afternoon). Here average pain intensity is reported. Average pain intensity was calculated as mean of morning pain intensity and evening pain intensity for each baseline and Day 15.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Units on a scale||Standard Deviation|Mean
1461596|NCT00766831|Secondary|Korean Brief Pain Inventory (K-BPI) Questionnaire Score|K-BPI is a questionnaire designed to measure the degree of pain severity and the impact of pain in performing daily routines. K-BPI comprises of 9 items out of which 6 items were assessed. Score of each item ranges from 0 to 10, where 0=no pain/impact and 10=severe pain/impact. The 6 items that were assessed are: a) level of pain worst in last 24 hours; b) level of pain weakest in last 24 hours; c) level of pain average in last 24 hours; d) level of pain right now; e) how much pain reduced with the therapy taken; sixth item was further classified into 7 categories: i) general activities ii) mood iii) ambulatory ability iv) routine works v) interpersonal relation vi) sleep vii) life enjoyment.|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies the number of participant who were evaluated for particular category at particular time point.|||Units on a scale||Standard Deviation|Mean
1461597|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Wake up Due to Unbearable Pain|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you wake up because of unbearable pain this morning?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1461598|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Frequency of Waking Up|The Investigator evaluated sleep disturbance through the participant’s answers to below question: How many times did you wake up while sleeping late night (frequency [once, 2 times, 3 times, 4 times, 5 times, couldn’t fall asleep at all] of waking up due to pain last night).|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used. Here 'n' signifies participants who were evaluated for this outcome measure at a particular time point.|||Participants|||Number
1461599|NCT00766831|Secondary|Sleep Disturbance Questionnaire: Analgesic Administration|"The Investigator evaluated sleep disturbance through the participant’s answers to below question in yes or no response: ‘Did you need to take an analgesic for pain relief in order to go to sleep last night?’"|Baseline and Day 15|ITT population included all the participants who received at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. LOCF was used.|||Participants|||Number
1461600|NCT00766831|Primary|Percentage of Treatment Response in Sleep Disturbance Caused by Cancer Pain|Percentage of treatment response in sleep disturbance caused by cancer pain was reported. Treatment response in sleep disturbance was measured by Numeric Rating Scale (NRS) ranging from 0=no disturbance to 10=extreme disturbance.|Day 15 or Early withdrawal|Intent to treat (ITT) population included all the participants who received study medication at least 1 dose of study medication and had the data on sleep disturbance caused by pain at Day 15. Last observation carried forward (LOCF) was used.|||Percentage of treatment response||95% Confidence Interval|Number
1461601|NCT00766753|Secondary|Overall Survival (OS)|Time interval from start of treatment until date of death.|Up to 102 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||months||90% Confidence Interval|Median
1461602|NCT00766753|Secondary|12-month- Progression Free Survival (PFS)|Number of patients with progression-free status lasting at least 12 months|Up to 12 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||participants|||Number
1461603|NCT00766753|Primary|Median Time To Progression|Median number of months until disease progression. Tumor size was assessed using magnetic resonance imaging (MRI) scans with contrast enhancement to detect change from baseline.|At baseline, 9, 17, 25, and 33 weeks, and every 3 months; up to 23 months|Patients with recurrent malignant glioma treated with novel vaccination with type 1 polarized dendritic cells ( DC1) loaded with synthetic peptides for (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and arboxymethylcellulose (poly-ICLC) who received at least one vaccine up to 4 vaccines|||months||Full Range|Median
1461604|NCT00766753|Primary|Number of Participants Who Experienced Treatment-related Dose Limiting Toxicities (DLT)|Number of participants who experienced treatment-related Dose Limiting Toxicities (DLT) at any dose level.|up to 8 weeks|Participants at any dose level, through the first booster phase.|||Participants|||Count of Participants
1461605|NCT00766675|Secondary|Number of Participants With Subject's Global Assessment|Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
1461606|NCT00766675|Secondary|Number of Participants With Physician Global Assessment|The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
1461607|NCT00766675|Secondary|Total Fibromyalgia Impact Questionnaire (FIQ) Score|The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.|Baseline and Day 56|"The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure and n signifies those participants who were evaluated for this measure at the specified time point."|||Units on a scale||Standard Deviation|Mean
1461608|NCT00766675|Secondary|Participant Assessment Sleep Questionnaire Score|Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to “How often during past 4 weeks did participant felt” and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1461609|NCT00766675|Secondary|Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept|The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant’s sleep habits out of which Q1 was “How long did it usually take for participant to fall asleep during the past 4 weeks” and Q2 was “On the average, how many hours did participant sleep each night during the past 4 weeks”.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Hours||Standard Deviation|Mean
1461610|NCT00766675|Secondary|Tender-Point Evaluation/ Myalgic Score|Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening.|Baseline and Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1461611|NCT00766675|Secondary|Number of Participants With Categorical Scores on Pain Relief Rating Scale|Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.|Day 14, 28 and 56|The ITT population included all enrolled participants.|||Participants|||Number
1461612|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 56|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 56|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
1461613|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 28|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 28|The ITT population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
1498046|NCT00488033|Secondary|Number of Participants With Hospitalization for Heart Failure||4 years||||Participants|||Count of Participants
1461614|NCT00766675|Primary|Pain Visual Analog Scale Score at Day 14|"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)."|Day 14|Intent to treat (ITT) population included all enrolled participants. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Millimeter (mm)||Standard Deviation|Mean
1461615|NCT00766649|Secondary|Change in Photoreceptor Outer Segment (PROS) Thickness as Measured by Optical Coherence Tomography at 24 Months as Compared to Baseline||Baseline and Month 24|||||||
1461616|NCT00766649|Secondary|Change in Drusen Volume as Measured by Optical Coherence Tomography (OCT) at 24 Months as Compared to Baseline||Baseline and Month 24|||||||
1461617|NCT00766649|Secondary|Change in Total Area of Drusen in the Fellow Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1461618|NCT00766649|Secondary|Change in Total Area of Drusen in the Study Eye at 24 Months as Compared to Baseline|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1461619|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24||||MPS DA/month||Standard Deviation|Mean
1461620|NCT00766649|Primary|Rate of Change in Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.|Baseline and Month 24||||MPS DA/month||Standard Deviation|Mean
1461621|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the fellow eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline and Month 24||||Ratio|Participants|Standard Deviation|Mean
1461622|NCT00766649|Secondary|Relative Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 24 months by the baseline value.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina. As the unit of measure for both the absolute change in the total area of GA and the baseline value for the total area of GA is MPS DA, the unit of measure for the relative change in the total area of GA is ratio."|Baseline to Month 24||||Ratio|Participants|Standard Deviation|Mean
1461623|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Fellow Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the fellow eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1461624|NCT00766649|Secondary|Absolute Change in Total Area of Geographic Atrophy (GA) in the Study Eye at 24 Months as Compared to Baseline|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 24.~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 24||||MPS DA|Participants|Standard Deviation|Mean
1461625|NCT00766649|Secondary|Number of Study Eyes With a 15 Letter Drop From Baseline at 24 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Month 24||||eyes|Participants||Number
1461635|NCT00766597|Primary|Number of Participants With Suspected Adverse Drug Reaction Leading to Treatment Termination|The protocol required reporting of signs and symptoms and laboratory abnormalities of >=Grade 2 and all grades of fever. The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules is to be determined by the Study Team. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR5-tropic virus who started treatment in Step II.|||participants|||Number
1461626|NCT00766636|Primary|Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.|Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report|Following resection performed at time of surgery, day 36 of treatment +/- 5 days|The study was terminated early without enough patients to perform any analysis between the groups. Of the five registered, one withdrew prior to any treatment and the others either had disease progression or left prior to surgery with incomplete preoperative regimen.||||||
1461627|NCT00766597|Secondary|Change in Plasma HIV RNA PCR|Changes in HIV RNA (copies/mL) from baseline to Week 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1461628|NCT00766597|Secondary|Change in Polymerase Genome and Envelope Sequence|Number of subjects with changes in genotypic and phenotypic drug resistance to the OBT and to vicriviroc (envelope sequence) from baseline to Week 24 and/or virologic failure will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1461629|NCT00766597|Secondary|Change in CD4 Percent|Change in CD4 percent from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1461630|NCT00766597|Secondary|Change in CD4 Counts|Change in CD4 count from baseline to weeks 24 will be presented both in the aggregate and broken down by age cohort.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1461631|NCT00766597|Secondary|Number of Participants With Changes in Co-receptor Tropism From Baseline|Among all patients enrolled in Step I, the prevalence of detectable coreceptor phenotype, R5 tropic, R5/X4 mixed and X4 tropic viruses will be evaluated. The extent to which coreceptor phenotype in Step I is associated with Step I CD4 cell count, HIV RNA, and age will be evaluated. The association of Step I coreceptor phenotype and nadir CD4, HIV subtype, number of ART regimens, and years of ART will be evaluated. At the time of virologic failure, the extent of change from Step I and/or baseline R5 tropic virus to R5/X4 mixed or to X4 tropic virus as detected by the TrofileTM assay will be evaluated.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1461632|NCT00766597|Secondary|Number of Participants Who Failed to Achieve =>1-log Drop From Baseline in HIV-1 Viral Load and HIV-1 Viral Load of =>400 Copies/mL (Virologic Failures)|Plasma HIV RNA (RNA) concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular). The primary definition of virologic success will require subjects to have achieved and maintained 1-log drops from baseline of HIV-1 RNA or HIV-1 RNA <400 copies/mL.|At Baseline, Week 24|HIV-1 infected ART-experienced participants with CCR5-tropic virus who started treatment in Step II and have reached Week 24. Measure was not analyzed since only one participant reached Week 24, no aggregate results were available for posting, and the individual participant-level data were not posted due to being potentially identifiable.||||||
1461633|NCT00766597|Primary|Number of Participants Who Failed to Meet PK Targets|For Stage I subjects who are enrolled in Step II, the average of the pre-dose and 24 hour post dose sample from the intensive PK evaluations of said subjects will be used as the estimate of Cmin. The whole cohort will fail the PK targets if the population target (median vicriviroc Cmin should be =>200 ng/mL) is not met, and that nearly all of subjects’ Cmin failed to be > 100 ng/mL.|At Week 24|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II and who failed the PK targets. Outcome measure not analyzed since the PK targets were for the whole cohort, but the lone cohort opened was not fully enrolled due to early study termination.||||||
1461634|NCT00766597|Primary|Number of Participants With Adverse Events of Grade 3 or Higher Severity|Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). All grade 3 and higher signs, symptoms, and laboratory toxicities were included.|From study entry to Week 24 or the early study termination whichever occurred earlier|The HIV-1 infected antiretroviral therapy experienced participants with CCR-5 tropic virus who started treatment in Step II|||participants|||Number
1461636|NCT00766532|Primary|Change in Intestinal Calcium Absorption Related to Aromatase Inhibitor Therapy|intestinal calcium absorption|baseline and 6 weeks later|12 subjects provided informed consent but two dropped and did not undergo calcium absorption study visits. 10 subjects completed all calcium absorption study visits.|||percent calcium absorption||Standard Deviation|Mean
1461849|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461637|NCT00766506|Other Pre-specified|Number of Participants Facing Technical Failure of the Device|Technical failure was defined as malfunctioning or failure of device to work appropriately.|Baseline up to end of study treatment (Hour 72)|Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once.|||Participants|||Number
1461638|NCT00766506|Secondary|Number of Participants Who Require Concomitant Non-opioid Analgesics|Non-opioid analgesics are non morphine like medications used to get relieve from pain.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
1461639|NCT00766506|Secondary|Number of Participants Who Require Concomitant Antiemetic Medication|Antiemetic medicines are the drugs which prevent vomiting.|Baseline up to end of study treatment (Hour 72)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
1461640|NCT00766506|Secondary|Number of Participants Who Require Rescue Medication|Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.|Baseline up to Hour 3|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Participants|||Number
1461641|NCT00766506|Other Pre-specified|Time to Actual Discharge|The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.|When participant was actually discharged from ward care (assessed up to 258.5 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Hours||95% Confidence Interval|Median
1461642|NCT00766506|Secondary|Time to Fit For Discharge (FFD)|Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a “Yes” or “No” basis. When all criteria were answered as Yes, participant was considered to be FFD.|When participant was FFD (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Hours||95% Confidence Interval|Median
1461643|NCT00766506|Secondary|Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control|The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: “Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?”|Hour 72 or early study withdrawal|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
1461644|NCT00766506|Secondary|Nurse Ease of Care (EOC) Questionnaire Score|Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from ‘not at all’ (Score 0) to ‘a very great deal’ (score 5). The total score was calculated as the mean of the non-missing items for all the questions.|When participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Units on scale||95% Confidence Interval|Least Squares Mean
1461645|NCT00766506|Secondary|Pain Intensity Numerical Rating Scale (NRS)|Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant’s pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.|Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)|The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here ‘n’ signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.|||Unit on Scale||Standard Deviation|Mean
1461646|NCT00766506|Primary|Participant’s Evaluation of Mean Ability to Mobilize After Surgery|The ability to mobilize was assessed through a combined analysis of participant’s responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from “not at all” (score 0) to “a very great deal” (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).|Hour 72 or early study withdrawal|The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).|||Units on scale||Standard Deviation|Mean
1461647|NCT00766493|Secondary|Neurologic Events|Neurological Events at 30 days post-procedure, including transient ischemic attacks (TIAs).|30 days||||Participants|||Number
1461648|NCT00766493|Secondary|Access Site Complications|Access Site Complications defined as the presence of a large hematoma (>5cm or requiring treatment or prolonged hospitalization), fistula or pseudoaneurysm formation, retroperitoneal bleeding or the need for surgical repair postprocedure.|30 days||||Participants|||Number
1461649|NCT00766493|Secondary|Clinical Success|Clinical Success defined as GORE Embolic Filter and carotid stent success in the absence of death, emergency endarterectomy, repeat PTA / thrombolysis of the target vessel, and stroke or MI as determined by the Clinical Events Committee. Clinical success will be evaluated from procedure through 24-48 hours postprocedure.|30 days||||Participants|||Number
1461650|NCT00766493|Secondary|Device Success|Device Success defined as the number of participants with Technical Success using the GORE Embolic Protection System (i.e., the GORE Embolic Filter device was delivered, placed, and retrieved as outlined in the Instructions for Use).|Post Procedure||||Participants|||Number
1461651|NCT00766493|Primary|Composite Major Adverse Event (MAE) Rate of Death, Myocardial Infarction, and Stroke at 30 Days Postprocedure||30 days|EMBOLDEN subjects evaluable for the primary endpoint|||Participants|||Number
1461652|NCT00766467|Secondary|Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment|To assess the side effect profile of armodafinil in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy treatment.|56 days|Grade 3 - 4 events at least possibly related to study treatment.|||number of incidents|||Number
1461653|NCT00766467|Secondary|Change From Baseline in Quality of Life at Days 22, 43 and 56|The effects of treatment on overall health-related quality of life quantified with the general Functional Assessment of Cancer Therapy survey (FACT-G) were measured at baseline, at day 22, at the end of radiation (day 43) and 2 weeks after completion of radiation (day 56). The FACT-G assesses quality of life based on physical, social/family, emotional, and functional well-being. Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). The total FACT-G score can range from 0-108, with higher scores indicating a better quality of life.|baseline, day 22, day 43, and day 56|Analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.|||units on a scale||80% Confidence Interval|Median
1461654|NCT00766467|Primary|Change From Baseline in Fatigue at Day 43|The primary endpoint was the difference in the 42-day change (baseline vs. day 43) in Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F scale) between the 2 treatment groups (those patients randomized to receive armodafinil and those randomized to the placebo arm). FACIT-F is a well-validated QOL instrument widely used for the assessment of cancer-related fatigue in clinical trials.5 It consists of the 27-item FACT-G (which assesses QOL based on physical, social/family, emotional, and functional well-being) and the 13-item FACIT-F fatigue subscale (which assesses the impact of fatigue on daily activities). Each item is assessed on a 5-point scale (0 = not at all to 4 = very much). By scoring convention, after appropriate reversal scoring of 11 items, the FACIT-F fatigue subscale (FACIT-fatigue) score ranges from 0 to 52 (lower score indicating more fatigue). A score < 30 indicates severe fatigue.|43 days|Primary analysis included participants with complete or near complete baseline and day 43 data irrespective of the amount of treatment received.|||units on a scale||80% Confidence Interval|Median
1461655|NCT00766415|Secondary|Adverse Event (AE)|Number of participants with an Adverse Event|1 month||||Participants|||Number
1461656|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score|Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1461657|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score|Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1461658|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score|Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1461659|NCT00766415|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score|Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1461660|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Evening|Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||95% Confidence Interval|Mean
1461661|NCT00766415|Secondary|Peak Expiratory Flow (PEF) Morning|Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||95% Confidence Interval|Mean
1461662|NCT00766415|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)|Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||95% Confidence Interval|Mean
1461700|NCT00765947|Secondary|Overall Safety and Tolerability of Aliskiren Monotherapy and in Combination Treatment||24 weeks|||||||
1466365|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1461663|NCT00766415|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage change||95% Confidence Interval|Mean
1461664|NCT00766415|Primary|Induced Sputum: Total Cells Count|Change in Induced sputum Total cells count from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||10^6/g||95% Confidence Interval|Mean
1461665|NCT00766415|Primary|Induced Sputum: Epithelial Cells Count (%)|Change in Induced sputum Epithelial cells count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461666|NCT00766415|Primary|Induced Sputum: Lymphocytes Count (%)|Change in Induced sputum Lymphocytes count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461667|NCT00766415|Primary|Induced Sputum: Macrophages Count (%)|Change in Induced sputum Macrophages count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461668|NCT00766415|Primary|Induced Sputum: Neutrophils Count (%)|Change in Induced sputum Neutrophils count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461669|NCT00766415|Primary|Induced Sputum: Eosinophil Count (%)|Change in Induced sputum Eosinophil count (% of total) from baseline|Before and after 3 week treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461670|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Total Cells Count|Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||10^6/g||95% Confidence Interval|Mean
1461671|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)|Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461672|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)|Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461673|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Macrophages Count (%)|Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461674|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Neutrophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461675|NCT00766415|Primary|Bronchoalveolar Lavage (BAL): Eosinophil Count (%)|Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||percentage||95% Confidence Interval|Mean
1461676|NCT00766415|Primary|Aggregated Pathology Score|Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.|Before and after 1 month treatment|Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure.|||Score on a scale||95% Confidence Interval|Mean
1461677|NCT00766376|Secondary|Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.|To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.|participants at three months||||Participants|||Number
1461850|NCT00764881|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461678|NCT00766376|Primary|Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.|To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.|participants at three months||||Participants|||Number
1461679|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])|Rivastigmine PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for rivastigmine after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||h*ng/mL||Standard Deviation|Mean
1461680|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)|Rivastigmine PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||hours||Standard Deviation|Mean
1461681|NCT00766363|Secondary|Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)|Rivastigmine PK data; Maximum Concentration (Cmax); i.e, highest concentration of rivastigmine in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters. Only 4 subjects took rivastigmine concomitantly.|||ng/mL||Standard Deviation|Mean
1461682|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|Donepezil PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot for donepezil (parent compound only) after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||h*ng/mL||Standard Deviation|Mean
1461683|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||hours||Standard Deviation|Mean
1461684|NCT00766363|Secondary|Donepezil PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|Donepezil PK data; Maximum Concentration (Cmax); i.e, highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||ng/mL||Standard Deviation|Mean
1461685|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])|EVP-6124 PK data; Area Under the Curve (AUC[0-24 h]); i.e, area under the concentration-time plot|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||h*ng/mL||Standard Deviation|Mean
1461686|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)|EVP-6124 PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||hours||Standard Deviation|Mean
1461687|NCT00766363|Secondary|EVP-6124 PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)|EVP-6124 PK data; Maximum Concentration (Cmax); i.e, highest concentration of drug in plasma|24 hours|PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.|||ng/mL||Standard Deviation|Mean
1461688|NCT00766363|Primary|Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer’s Disease|All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis)|Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only]|Safety Population: All randomized subjects who ingested at least 1 dose of study drug.|||Participants|||Number
1461689|NCT00766090|Secondary|Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods|Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population|||participants|||Number
1461690|NCT00766090|Secondary|Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period|Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1461691|NCT00766090|Secondary|Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1494696|NCT00517192|Primary|Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.||48 weeks of treatment|||||||
1461692|NCT00766090|Secondary|Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period|Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.|Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1461693|NCT00766090|Secondary|24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period|A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.|Day 28 of the relevant treatment period (up to Study Day 112)|Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results|||Nanomoles per 24 hours||Geometric Coefficient of Variation|Geometric Mean
1461694|NCT00766090|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.|From the first dose of the study medication up to Week 16/Early Withdrawal|ITT Population|||participants|||Number
1461695|NCT00766090|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.|Day 28 of the relevant treatment period (up to Study Day 112)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication|||Liters||Standard Error|Least Squares Mean
1461696|NCT00766051|Secondary|"A Priori H4: A Total Scale Score of Parents' Perception of Infant Easiness (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Easiness Scale measures the parent's perceived efficacy in the areas of infant irritability, sleeping habits, alertness and responsiveness, and difficulty. The Easiness Scale(Wolke [in Brazelton and Nugent], 1995]) was used to determine mother/parent perceptions of their infants' mood and state in the NICU as a result of training in NBOTI. An increasing score denotes an improvement in parent efficacy in their perception of their infant's easiness.uses a Likert scale. There are four questions, ranging from -3-3. The maximum score is 12, and the minimum score is -12.|Upon an infant's entry into the study, and again at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.|||Scores on Scale||Standard Deviation|Mean
1461697|NCT00766051|Secondary|"A Priori H3: A Total Score of the Parents' Global Confidence (Wolke, 1995) Was Measured on a Pre-post Test Scale."|The Global Confidence Scale of The Mother and Baby Scales (Wolke [in Brazelton and Nugent], 1995]) is a total score measure of mother/parent self efficacy in the NICU as a result of training in NBOTI. It is a total score measure of the parent's perceived efficacy of themselves as confidence in the feeding, handling, caretaking, and interactions needed to foster relationships with their infants. An increase in this score denotes an increase in the parent's perception of their global confidence in caring for their infant. Global Confidence Measure uses a Likert scale. There are three questions, ranging from -3-3. The maximum score is 9, and the minimum score is -9.|Upon an infant's entry into the study, and at discharge (at or less than 20 days).|The intervention group consisted of Three Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, Two near term infants with Omphalocele, and One near term infant Congenital Diaphragmatic Hernia.|||scores on scale||Standard Deviation|Mean
1461698|NCT00766051|Secondary|A Priori H2: The Increase in Oral Feeding Percentage Over Days Was Correlated With Increasing Respiratory Competency During Oral Feeding; Measured as the High Frequency Percentage (HF%) of Intervention Groups' Heart Rate Variability (HRV) During Feeding.|Oral feeding percentage was based upon 150 kc/kg/day. Heart rate data was recorded about once per week during feeding using a Holter monitor connected to the bedside ecg. This data was downloaded in Cardiology, converted to numerical data as HRV by bioengineers at Politecnico di Milano, Italy. As infants reached 100% of oral feedings, heart rate variability data was analyzed to determine the infants' overall trend toward relaxation, measured as increasing High Frequency Percentage (HF %). Hierarchical linear modeling (HLM) (Singer and Willett, 2003) SPSS Grad Pack 17, mixed model analysis.|The time frame was from Baseline until discharge (at or before 20 days).|The intervention group consisted of Four Preterm infants with high risk factors, Three term or near term infants with Gastroschisis, and Two near term infants with Omphalocele. This outcome measured the correlation between the percentage of oral feedings and the percentage of High Frequesncy Heart Rate Variability.|||Percentage||Standard Deviation|Mean
1461699|NCT00766051|Primary|A Priori H1. The Number of Days to Achieve Oral Feeding Between the Intervention Group and the Matched Historical Comparison Group - From All Tube to All Oral Feeding - Was Analyzed.|This outcome measured the number of days it took to go from all tube to all oral feeding or at discharge, whichever came first. Oral feeding percentages were based upon 150 kcal/kg/day. Feeding volumes and weights were taken directly from the nurses notes, and averaged daily. A two sample t-test was used to detect differences between the groups.|The time frame was from Baseline until all oral feeding or discharge, whichever came first (at or before 35 days).|The intervention group and matched historical comparison group consisted of Four pairs of Extremely Preterm to Preterm infants with high risk factors, Three pairs of term or near term infants with Gastroschisis, Two pairs of infants term or near term with Omphalocele, and One pair of infants term age with Congenital Diaphragmatic Hernia.|||Days||Standard Deviation|Mean
1461701|NCT00765947|Secondary|Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]|Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).|24 weeks||||Percentage of Participants|||Number
1461702|NCT00765947|Secondary|Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]||Baseline and Week 24|Full analysis set|||mm Hg||Standard Deviation|Mean
1461703|NCT00765947|Secondary|Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks||||Percentage of Participants|||Number
1461704|NCT00765947|Primary|Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen|For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.|24 weeks|Full analysis set|||Percentage of participants|||Number
1461705|NCT00765895|Primary|Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits|A decrease from the baseline Gastroparesis Cardinal Symptom Index (GCSI) score (sum of the 9 individual symptom scores) of at least 50% on any two consecutive follow-up visits during the 15 week treatment period with maximum tolerated study drug dose. The total score ranges from 0-45 with higher scores indicating greater symptom severity.|at end of treatment, 15 weeks from baseline assessment|intention to treat|||participants||95% Confidence Interval|Number
1461706|NCT00765882|Secondary|12-Week Constipation Severity|Constipation severity was based on a 5-point ordinal scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 11 additional patients who dropped out prior to finishing 1 week of the trial were excluded from the Constipation Severity endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1461707|NCT00765882|Secondary|12-Week Bloating|Bloating was based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe”.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT population; 1 additional patient without a baseline Bloating score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1461708|NCT00765882|Secondary|12-Week Abdominal Discomfort|Abdominal discomfort is based on a 5-point scale where a value of l is “none” and a value of 5 is “very severe.”|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. 1 additional patient without a baseline Abdominal Discomfort score was excluded from analysis in this endpoint. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1461709|NCT00765882|Secondary|12-Week Severity of Straining|Straining is measured on a 5-point scale, where a value of 1 is “not at all” and a value of 5 is “an extreme amount.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 Patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Severity of Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1461710|NCT00765882|Secondary|12-Week Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the ITT Population; 97 patients with no pretreatment spontaneous bowel movements were excluded from the 12-Week Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1461711|NCT00765882|Secondary|12-Week Spontaneous Bowel Movement (SBM) Frequency Rate|A patient’s 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||SBM per week||Standard Error|Least Squares Mean
1461712|NCT00765882|Secondary|12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|The number of CSBMs per week.|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||CSBM per week||Standard Error|Least Squares Mean
1461728|NCT00765817|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1504186|NCT00440830|Secondary|Diastolic Blood Pressure|Diastolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery|||||||
1461713|NCT00765882|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.~A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|A total of 633 patients were randomized to treatment and received at least 1 dose of study drug. 630 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1461714|NCT00765843|Primary|Heel Pain|Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.|baseline, one month and three months||||score on a survey||Standard Deviation|Mean
1461715|NCT00765817|Secondary|Percentage of Subjects Experiencing Minor Hypoglycemia|Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set|||percentage|||Number
1461716|NCT00765817|Secondary|Minor Hypoglycemia Rate Per Year|Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL).|baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30|Full analysis set|||events per subject per year||Standard Deviation|Mean
1461717|NCT00765817|Secondary|Change in Diastolic Blood Pressure (DBP)|Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmHg||Standard Error|Least Squares Mean
1461718|NCT00765817|Secondary|Change in Systolic Blood Pressure (SBP)|Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmHg||Standard Error|Least Squares Mean
1461719|NCT00765817|Secondary|Change in Daily Insulin Dose (on a Per Body Weight Basis)|Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||insulin units per kg (U/kg)||Standard Error|Least Squares Mean
1461720|NCT00765817|Secondary|Change in Daily Insulin Dose|Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||insulin units (U)||Standard Error|Least Squares Mean
1461721|NCT00765817|Secondary|Change in Waist Circumference|Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||cm||Standard Error|Least Squares Mean
1461722|NCT00765817|Secondary|Change in Body Weight|Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||kg||Standard Error|Least Squares Mean
1461723|NCT00765817|Secondary|Change in Triglycerides|Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)|baseline and 30 weeks|Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1461724|NCT00765817|Secondary|Change in High Density Lipoprotein (HDL) Cholesterol|Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Least Squares Mean
1461725|NCT00765817|Secondary|Change in Low Density Lipoprotein (LDL) Cholesterol|Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1461726|NCT00765817|Secondary|Change in Total Cholesterol|Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1461727|NCT00765817|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)|baseline and 30 weeks|Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||mmol/L||Standard Error|Least Squares Mean
1461764|NCT00765388|Secondary|Adhesion of the Bag During Use|Evaluation of the adhesion of the base plate around the stoma during use|4 weeks|ITT population|||Participants|||Number
1461729|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=6.5%|Percentage of patients in each arm who had HbA1c >6.5% at baseline and had HbA1c <=6.5% at week 30 (percentage = [number of subjects with HbA1c <=6.5% at week 30 divided by number of subjects with HbA1c >6.5% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.|||percentage|||Number
1461730|NCT00765817|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 30 (percentage = [number of subjects with HbA1c <=7% at week 30 divided by number of subjects with HbA1c >7% at baseline] * 100%).|baseline and 30 weeks|Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c > target were included in calculation.|||percentage|||Number
1461731|NCT00765817|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.|baseline and 30 weeks|Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis|||percentage of hemoglobin||Standard Error|Least Squares Mean
1461732|NCT00765765|Primary|Tumor Response Rate|Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase II portion of the ixabepilone plus hydroxychloroquine combination treatment study, a tumor response rate of less than 15% will be deemed uninteresting. The target tumor response rate will be 35%. Due to uncertainty about the true response rate of ixabepilone plus hydroxychloroquine combination on this patient poupation, we also will consider a response rate of 30% to be encouraging.|3 years|The study was closed early due to slow accrual. Insufficient data were collected to evaluate this outcome measure.||||||
1461733|NCT00765765|Secondary|Correlation of Estrogen Receptor, Progesterone Receptor and/or HER2 Status With Treatment Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
1461734|NCT00765765|Secondary|Effects of Hydroxychloroquine on Autophagy||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
1461735|NCT00765765|Secondary|Pharmacodynamic Markers for Autophagy Detection||2 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
1461736|NCT00765765|Secondary|Survival Time||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
1461737|NCT00765765|Secondary|Time to Progressive Disease||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
1461738|NCT00765765|Secondary|Duration of Response||5 years|The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.||||||
1461739|NCT00765726|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.|Month 24 or early withdrawal|Safety analysis population included all enrolled participants who had taken at least 1 dose of the study medication.|||Percentage of participants||95% Confidence Interval|Number
1461740|NCT00765674|Secondary|Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)|Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
1461741|NCT00765674|Secondary|Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)|Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.|End of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||Percentage of patients|||Number
1461742|NCT00765674|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
1461765|NCT00765388|Secondary|Removal of the Bag|How easy/difficult it was to remove the bag|4 weeks|ITT population|||Participants|||Number
1461766|NCT00765388|Secondary|Immediate Adhesion|Evaluation of immediate adhesion after each period|4 weeks|Intention to treat (ITT)|||Participants|||Number
1461743|NCT00765674|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)|Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.|Baseline to end of study (Week 8)|Full analysis set population: All randomized patients who had post-baseline efficacy measurements.|||mmHg||Standard Error|Least Squares Mean
1461744|NCT00765661|Secondary|Evaluation of Safety and Efficacy of LCP-Tacro Compared to Prograf in Adult de Novo Kidney Transplant Patients.|"To evaluate the efficacy and safety of LCP-Tacro compared to Prograf in the first 12 months after kidney transplantation.~Efficacy was assessed by monitoring biopsy-proven acute rejection (BPAR) according to the Banff criteria, graft failure (defined by a patient starting dialysis for at least 30 days, nephrectomy, retransplantation, or death with a functioning graft), patient survival, and renal function based on serum creatinine and glomerular filtration rate (GFR), based on serum creatinine, serum urea nitrogen, and serum albumin."|12 months|All patients receiving at least one dose of study drug was included in the safety evaluation.|||participants|||Number
1461745|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.|||ng*hr/mL||Standard Deviation|Mean
1461746|NCT00765661|Secondary|Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.|To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.|14 days|The outcome measure is listed as arithmetic mean of the pharmacokinetic parameters for raw data (not dose corrected) for tacrolimus in the ITT population on Day 14.|||ng/mL||Standard Deviation|Mean
1461747|NCT00765661|Primary|Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.|Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation|14 days||||percentage of patients|||Number
1461748|NCT00765648|Secondary|Transition Time to Oral Medication|The median transition time (in hours) to oral medication|6 hours|these are the correct participant numbers for this secondary analysis|||hours||Inter-Quartile Range|Median
1461749|NCT00765648|Secondary|Subjects Requiring the Use of Intravenous Rescue Medications|The percent of subjects requiring the use of intravenous rescue medications|6 hours||||percentage of participants|||Number
1461750|NCT00765648|Secondary|Treatment Failure|Treatment failure is defined as admission to the hospital or observation unit for BP management|6 hours|these are the correct participant numbers for this secondary analysis|||percentage of participants|||Number
1461751|NCT00765648|Secondary|Emergency Department(ED)Time to Disposition Decision|Median number of hours from hospital admission until Emergency Department(ED)disposition|6 hours|these are the correct participant numbers for this secondary analysis|||hours||Inter-Quartile Range|Median
1461752|NCT00765648|Secondary|Average Number of Dose Titrations Within 30 Minutes|Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group|30 minutes||||number of titrations||Standard Deviation|Mean
1461753|NCT00765648|Primary|Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.|Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.|30 minutes after initiation of therapy|Intent to treat cohort.|||percentage of participants|||Number
1461754|NCT00765570|Secondary|Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.|Complete response (CR) = 100% tumor disappearance Partial response (PR) = > 50% reduction in size Stable disease (SD) = < 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = > 10% increase in size of tumor Unknown Status (UK)|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.||||participants|||Number
1461755|NCT00765570|Primary|Protocol Treatment Related Morbidity|Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy|during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.||||events|||Number
1461756|NCT00765388|Secondary|Changes in Skin Compared to Before Study|The patient was asked whether he/she experienced changes in the skin condition after testing the blue/red product|4 weeks|ITT population|||Participants|||Number
1461757|NCT00765388|Secondary|Bag Twisting During Night|The patient was asked if he/she noticed whether the bag twisted during night|4 weeks|ITT population|||Participants|||Number
1461758|NCT00765388|Secondary|Problems With Splashing Sounds During Use|The patient was asked whether he/she noticed any splashinh sounds during use|4 weeks|ITT population|||Participants|||Number
1461759|NCT00765388|Secondary|Feeling of Security During the Night|The patients feeling of security with the product during the night|4 weeks|ITT population|||Participants|||Number
1461760|NCT00765388|Secondary|Feeling of Security During the Day|The patients feeling of security with the bag during the day|4 weeks|ITT population|||Participants|||Number
1461761|NCT00765388|Secondary|Awareness of the Presence of the Product|Evaluates the patients awareness of the presence of the product during use.|4 weeks|ITT population|||Participants|||Number
1461762|NCT00765388|Secondary|Flexibility of the Product|Evaluation of the ability of the bag to conform with the patients movements (flexibility)|4 weeks|ITT population|||Participants|||Number
1461763|NCT00765388|Secondary|Adhesives Ability to Absorb Perspiration|Evaluation of the adhesives ability to absorb perspiration from the skin|4 weeks|ITT population|||Participants|||Number
1461769|NCT00765362|Primary|Knee Society Scores Used as Success/Failure Criteria.|The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Percentage of Participants with Success|||Number
1461770|NCT00765362|Primary|Knee Society Function Score|The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Average Knee Function Score||Standard Deviation|Mean
1461771|NCT00765362|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.|||Average Knee Rating Score||Standard Deviation|Mean
1461772|NCT00765336|Primary|Mean Percent Change From Screening in Sperm Concentration.||Baseline and 12 Weeks|The enrollment was designed to ensure study completion of approximately 150 subjects. Actual enrollment was 180 subjects (92 in the minocycline group, 88 in the placebo group). A total of 145 subjects (72 in the minocycline group, 73 in the placebo group) comprised the completed population group.|||Percent change||Standard Deviation|Mean
1461773|NCT00765245|Other Pre-specified|Exploratory: Concordance Between IHC for GCB and Non-GCB Subtypes to the Gene Expression Profiles Associated With the Subtypes||up to two years|||||||
1461774|NCT00765245|Other Pre-specified|Investigate Potential Predictive Biomarkers of Clinical Response or Resistance to Lenalidomide||up to two years|||||||
1461775|NCT00765245|Secondary|Number of Patients With Each Worst‐Grade Toxicity|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death. Toxicities present at baseline and continuing without change in grade are excluded when considering worst‐grade toxicity.|30 days after completing treatment, for up to 13 months|Total number of patients reported with any toxicity|||participants|||Number
1461776|NCT00765245|Secondary|Disease-free Survival at 2 Years|Disease-free survival is the estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method where death is an event, with censoring for non‐expired patients at last known date alive.|From on-treatment date to disease recurrence, up to 2 years||||years||95% Confidence Interval|Median
1461777|NCT00765245|Primary|Disease-free Survival at 1 Year|Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Those who are alive and without relapse are censored at the last date known alive.|From on-treatment date to disease recurrence, up to 1 year||||years||95% Confidence Interval|Mean
1461778|NCT00765232|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery||||mg||Standard Deviation|Mean
1461779|NCT00765232|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery||||units on a scale||Standard Deviation|Mean
1461780|NCT00765206|Primary|Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration|The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.|Baseline and 7 days||||pH scale||Full Range|Median
1461781|NCT00765193|Secondary|Whether a Systematic Screening is Related to a Higher Number of Unnecessary Excisions of Benign Skin Tumors Detected During the Screening.||one year|||||||
1461782|NCT00765193|Primary|Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.||one year|From a population of patients with various skin conditions, participants were considered for inclusion only if aged 18 years or more, and if suffering from focused skin complaints. Patients with diffuse skin complaints were excluded.|||participants|||Number
1461783|NCT00765128|Primary|Morphine Equivalents of Concomitant Pain Medication|The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.|24 hours after the end of surgery||||mg||Standard Deviation|Mean
1461784|NCT00765128|Primary|Pain 'Right Now'|Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.|24 hours after the end of surgery||||units on a scale||Standard Deviation|Mean
1461785|NCT00765102|Secondary|Kaplan Meier Estimates for Overall Survival|Overall survival is the time from initiation of therapy to death from any cause.|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1461809|NCT00765076|Secondary|The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains.|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
1461786|NCT00765102|Secondary|Kaplan Meier Estimates for Progression-free Survival Assessed by the Investigator|"Progression-free survival is the time from initiation of therapy to progressive disease, removal from study for any reason, death from any cause, or the last follow-up visit, whichever occurs first.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1461787|NCT00765102|Secondary|Kaplan Meier Estimate for Duration of Response Assessed by the Investigator|"Duration of response is defined as the time from first response to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1461788|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Response Assessed by the Investigator|"The time to the first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (complete response, very good partial response, partial response or minimal response).~Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other."|up to month 8|Intent to treat population. However efficacy data was not analyzed due to the early termination of the study.||||||
1461789|NCT00765102|Secondary|Kaplan Meier Estimate for Time to Progression Assessed by the Investigator|"Time to progression of disease is defined as the time from initiation of therapy to progressive disease as assessed by the investigator.~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia.~Disease progression for participants relapsing from a complete response: reappearance of serum or urinary paraprotein on imunofixation, >= 5% plasma cells in the bone marrow aspirate or biopsy, increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, development of hypercalcemia."|up to month 8|Intent to treat population. Analysis was not performed due to early termination of the study.||||||
1461790|NCT00765102|Secondary|Total Volume of Distribution (Vz)|Total volume of distribution of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||L||Geometric Coefficient of Variation|Geometric Mean
1461791|NCT00765102|Secondary|Total Clearance (CL)|Total clearance of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1461792|NCT00765102|Secondary|Terminal Half-life (t1/2)|Terminal half-life of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||hr||Geometric Coefficient of Variation|Geometric Mean
1461793|NCT00765102|Secondary|Time to Maximum Observed Concentration (Tmax)|Time to maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||hr||Full Range|Median
1461794|NCT00765102|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of Romidepsin|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1461795|NCT00765102|Secondary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0–∞)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) of Romidepsin based on plasma samples.|Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion|A subset of participants from the lead investigator's site had PK samples taken.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1461796|NCT00765102|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.|up to 9 months|Safety population of participants who took at least one dose of drug.|||participants|||Number
1461838|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461797|NCT00765102|Primary|Count of Participant Best Overall Response As Assessed by the Investigator|"Complete Response: disappearance of monoclonal protein from blood and urine, and disappearance of soft tissue plasmacytomas, <5% plasmas cells in marrow and no increase of lytic bone lesions.~Very Good Partial Response: disappearance of plasmacytomas, no increase of lytic bone lesions, serum and urine M-protein not detectable by immunofixation, other.~Partial Response: >=50% decrease in serum monoclonal protein, and in soft tissue plasmacytomas, no increase of lytic bone lesions, other.~Minimal Response (MR): ≥ 25% to ≤ 49% decrease in serum monoclonal protein, and in size of plasmacytomas, no increase of lytic bone lesions, other.~Stable Disease: Less than MR, but not PD~Progressive Disease(PD):>25% increase in serum monoclonal paraprotein, or >25% plasma cells in marrow, or >25% increase in 24-hour urinary light chain excretion or increase in existing lytic bone lesions or soft tissue plasmacytomas or new bone lesions or soft tissue plasmacytomas, or hypercalcemia."|up to 8 months|Intent-to-Treat (ITT) population of patients defined as all patients who receive at least one dose of romidepsin and bortezomib. However efficacy data was not analyzed due to the early termination of the study.||||||
1461798|NCT00765076|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1461799|NCT00765076|Secondary|Number of Subjects Reporting Any AEs of Specific Interest (AESI)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.|Day 0-364|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1461800|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs)|For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1461801|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1461802|NCT00765076|Secondary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
1461803|NCT00765076|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1461804|NCT00765076|Secondary|Duration of Solicited Local AEs|Duration was defined as the number of days with any grade of local symptoms.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom.|||Days||Full Range|Median
1461805|NCT00765076|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.|Day 0 -6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1461806|NCT00765076|Secondary|The Number of Subjects Seroprotected to HI Antibodies|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.|At Day 0, 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
1461807|NCT00765076|Secondary|HI Antibody Seroconversion Factors|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||fold increase||95% Confidence Interval|Geometric Mean
1461808|NCT00765076|Secondary|The Number of Subjects Seroconverted to HI Antibodies|Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21, 42 and 180|The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||Participants|||Count of Participants
1461839|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461810|NCT00765076|Secondary|Haemagglutinin Inhibition (HI) Antibody Titers|Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.|At Day 0, 21, 42 and 180|The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||titer||95% Confidence Interval|Geometric Mean
1461811|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
1461812|NCT00765076|Secondary|The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers|The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.|At Day 0, 21, 42 and 180|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
1461813|NCT00765076|Primary|The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers|The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)|Day 21|Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group.|||cells per million CD4+ Tcells||Standard Deviation|Geometric Mean
1461814|NCT00765063|Secondary|36-Item Short-Form Health Survey (SF-36) Score|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.|||Units on a scale||Standard Deviation|Mean
1461815|NCT00765063|Secondary|11-point Likert Pain Scale|The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant’s pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain.|Baseline and Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Units on a scale||Standard Deviation|Mean
1461816|NCT00765063|Secondary|Number of Participants With Major Cardiovascular Disease Events (MCVE)|MCVE were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Participants|||Number
1461817|NCT00765063|Secondary|Time to First Amputation||Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Months||95% Confidence Interval|Median
1461818|NCT00765063|Secondary|Time to Intact Skin Healing|Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.|Baseline through Week 24 (EOT) or ET|The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.|||Months||95% Confidence Interval|Median
1461819|NCT00765063|Secondary|Number of Participants Who Underwent Amputation|A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Participants|||Number
1461820|NCT00765063|Secondary|Number of Participants With Improved Ulcer Healing|Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.|Baseline through Week 24 (EOT) or ET|ITT population included all participants who were enrolled into the study.|||Participants|||Number
1461821|NCT00765063|Secondary|Number of Participants With Intact Skin Healing|Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.|Baseline through Week 24 (EOT) or ET|Intent to treat (ITT) population included all participants who were enrolled into the study.|||Participants|||Number
1461822|NCT00765063|Primary|Number of Trivial Hemorrhages|Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1461840|NCT00764881|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461823|NCT00765063|Primary|Number of Clinically Relevant Minor Hemorrhages|Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1461824|NCT00765063|Primary|Number of Minor Hemorrhages|Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1461825|NCT00765063|Primary|Number of Major Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular).|Baseline to Week 24 (EOT) or ET|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1461826|NCT00765063|Primary|Number of All Hemorrhages|Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of greater than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.|Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)|Safety analysis population included all participants who were known to have taken at least one dose of the study medication.|||Hemorrhages|||Number
1461827|NCT00765037|Primary|Survivorship of the Encore Reverse Shoulder Prosthesis|Number of subjects who completed all study visits through the 1 year visit.|1 year||||participants|||Number
1461828|NCT00764946|Primary|Number of Participants Who Discontinued Due to an Adverse Event|Numbers of participants who discontinued due to an adverse event were summarized by race.|Week 48||||Participants|||Number
1461829|NCT00764946|Primary|Number of Participants With One or More Adverse Events|Numbers of participants with one or more adverse events were summarized by race.|Week 48||||Participants|||Number
1461830|NCT00764946|Secondary|Number of Participants Without Loss of Virologic Response|For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free).|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.|||participants|||Number
1461831|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count|Mean changes from baseline in CD4 cell counts were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."|||cells/mm^3||95% Confidence Interval|Mean
1461832|NCT00764946|Secondary|Mean Change From Baseline to Week 48 in HIV RNA|Mean changes from baseline in plasma HIV RNA were summarized by race at each time point.|Baseline and Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had baseline and at least one postbaseline evaluation.~Baseline values were carried forward for participants who discontinued before Week 48 due to lack of efficacy."|||log10 copies/mL||95% Confidence Interval|Mean
1461833|NCT00764946|Secondary|Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point.|Week 48|Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation. The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values.|||Participants|||Number
1461834|NCT00764946|Primary|Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point.|Week 48|"Efficacy analyses were based on the Full Analysis Set population that included all participants who took at least one dose of study medication and had at least one postbaseline evaluation.~The Treatment-Related Discontinuation = Failure approach was used as the primary method for handling missing HIV RNA values."|||Participants|||Number
1461835|NCT00764881|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461836|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461837|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1495796|NCT00508924|Primary|Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.||5 - 10 min after initial bolus||||second||Inter-Quartile Range|Median
1461851|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461852|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461853|NCT00764881|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.|From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461854|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461855|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461856|NCT00764881|Secondary|Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461857|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461858|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461859|NCT00764881|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461860|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461861|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461862|NCT00764881|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461863|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461864|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461865|NCT00764881|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461866|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461867|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461868|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461869|NCT00764881|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461870|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461871|NCT00764881|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461872|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1461873|NCT00764881|Secondary|Number of Spotting Only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1461874|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461875|NCT00764881|Secondary|Number of Spotting Only Days in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461876|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461877|NCT00764881|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461878|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461879|NCT00764881|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461880|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461881|NCT00764881|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461882|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1461883|NCT00764881|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||episodes||Standard Deviation|Mean
1461884|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 2|Reference Period 2 is defined as Day 91 to 180 during study treatment|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461885|NCT00764881|Secondary|Number of Bleeding / Spotting Days in Reference Period 1|Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure.|||Days||Standard Deviation|Mean
1461886|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461930|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline|Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461887|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461888|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline|The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).|At Baseline|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461889|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461890|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461891|NCT00764881|Secondary|Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline|ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461892|NCT00764881|Secondary|Vaginal Effects Evaluated by Vaginal pH at Cycle 6|Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Proportion of participants|||Number
1461893|NCT00764881|Secondary|Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461894|NCT00764881|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Percentage of participants|||Number
1461895|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Vitality|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461896|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Cycle 6|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461897|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Vitality at Baseline|Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461898|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – General Health|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461899|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Cycle 6|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461900|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – General Health at Baseline|General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461948|NCT00764790|Secondary|Number of Subjects Reporting Rare Serious Events|Rare serious events have an occurrence rate of 1/300 (0.3%).|During the entire study (Day 0 until Month 6)||||Participants|||Count of Participants
1461901|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Self-control|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461902|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Cycle 6|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461903|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Self-control at Baseline|Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461904|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Positive Well-being|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461905|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Cycle 6|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461906|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Positive Well-being at Baseline|Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461907|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Depressed Mood|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461908|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Cycle 6|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461909|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Depressed Mood at Baseline|Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461910|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) – Anxiety|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461911|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Cycle 6|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461912|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) – Anxiety at Baseline|Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461913|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score|Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1466366|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1461914|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6|The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461915|NCT00764881|Secondary|The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline|The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant|At Baseline|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1461916|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461917|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6|Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461918|NCT00764881|Secondary|The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline|Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461919|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score|Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461920|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461921|NCT00764881|Secondary|The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline|Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461922|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Total Score|The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461923|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Cycle 6|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461924|NCT00764881|Secondary|The Mean Absolute Values of FSFI Total Score at Baseline|The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
1461925|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)|Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461926|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461927|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.|Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461928|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)|Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461929|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6|Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461931|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)|Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461932|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6|Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461933|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline|Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461934|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)|Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1461935|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1461936|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline|Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||Scores on a scale||Standard Deviation|Mean
1461937|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)|Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1461938|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6|Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1461939|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline|Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
1461940|NCT00764881|Secondary|Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)|Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1461941|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1461942|NCT00764881|Secondary|The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline|Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).|At Baseline|FAS|||scores on a scale||Standard Deviation|Mean
1461943|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Per Protocol Set (PPS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|Per Protocol Set (PPS) includes those participants of the FAS without major protocol deviations affecting the primary variables|||scores on a scale||Standard Deviation|Mean
1461944|NCT00764881|Primary|Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) – Full Analysis Set (FAS)|Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1461945|NCT00764868|Secondary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and Up to 52 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1461946|NCT00764868|Secondary|Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 52 weeks|FAS|||Percent of participants|||Number
1461947|NCT00764868|Primary|Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and up to 52 weeks|Full Analysis Set (FAS) defined as all subjects who took at least 1 dose of investigational product and have a valid baseline and at least 1 valid follow-up assessment of the primary outcome measure.|||Units on a scale||Standard Deviation|Mean
1461949|NCT00764790|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)|"An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.~NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders"|During the entire study (Day 0 until Month 6)||||Participants|||Count of Participants
1461950|NCT00764790|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During a 28-day follow-up period after vaccination||||Participants|||Count of Participants
1461951|NCT00764790|Secondary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1461952|NCT00764790|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed include pain, redness and swelling.|During a 4-day follow-up period after vaccination|Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1461953|NCT00764790|Secondary|Seroconversion Factor|"Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity|||fold increase||95% Confidence Interval|Mean
1461954|NCT00764790|Secondary|Number of Seroprotected Subjects|"A seroprotected subject is a subject with a serum anti-HA titer~≥ 1:40~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
1461955|NCT00764790|Primary|Number of Subjects Who Seroconverted|"Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 28 or Day 56|Analysis was performed on the ATP cohort for analysis of immunogenicity|||Participants|||Count of Participants
1461956|NCT00764790|Primary|Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains|"GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.~Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects"|Day 0 (PRE), Day 28 or Day 56 (POST)|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.|||titre||95% Confidence Interval|Geometric Mean
1461957|NCT00764699|Primary|The Primary Outcome Variable for the Monitoring Study (Baseline, Six Months and Disease Exacerbation) Will be Longitudinal Growth as Measured by Height Velocity||Six months and 1 year|The PI left the institution suddenly and participant records stayed with the institution, so no analysis was able to be performed.||||||
1461958|NCT00764673|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|All subjects in the study were evaluated for adverse events.|||Events|||Number
1461959|NCT00764673|Primary|Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component.|Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.|2-year|The number of subjects who came in for a 2 year visit and completed the x-ray portion of the evaluation.|||participants|||Number
1461960|NCT00764673|Secondary|Oxford Knee Score|Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.|2-year|The number of subjects who completed an Oxford Knee score questionnaire at the 2 year visit.|||Units on a scale||Standard Deviation|Mean
1461961|NCT00764673|Primary|Knee Society Function Score|The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.|2-year|The number of subjects who completed their 2 year visit and had available data to collect for this evaluation.|||Average Knee Function Score||Standard Deviation|Mean
1461962|NCT00764673|Primary|Knee Society Score Evaluation|The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).|2 year|The number of subjects who completed their 2 year visit.|||Average Knee Rating Score||Standard Deviation|Mean
1461963|NCT00764660|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 12 weeks|The APT population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1462047|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1461964|NCT00764660|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.|Up to 16 weeks|The All-Participants-Treated (APT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
1461965|NCT00764660|Secondary|Change From Baseline in Mood VAS Score|Participants were asked to answer the question: “Over the past week, how did you feel?” The 100 mm line of the VAS was anchored on the left by “Extremely bad” and on the right by “Extremely good”. Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1461966|NCT00764660|Secondary|Change From Baseline in Motivation VAS Score|Participants were asked to answer the question: “Over the past week, how motivated were you to stay alcohol abstinent?” The 100 mm line of the VAS was anchored on the left by “No motivation at all” and on the right by “Extremely motivated”. Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1461967|NCT00764660|Secondary|Change From Baseline in Craving Visual Analog Scale (VAS) Score|Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: “Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?” The 100 mm line of the VAS was anchored on the left by “No desire at all” and on the right by “Extreme desire”. Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome.|Baseline and Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
1461968|NCT00764660|Secondary|Global Functioning: CGI - Therapeutic Effect|The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||Standard Deviation|Mean
1461969|NCT00764660|Secondary|Global Functioning: Clinical Global Impression (CGI) - Severity of Illness|The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome.|Day 84|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Score on a Scale||Standard Deviation|Mean
1461970|NCT00764660|Secondary|Percentage of Participants With Complete Abstinence|Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Participants|||Number
1461971|NCT00764660|Secondary|Percentage of Abstinent Days|Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1461972|NCT00764660|Secondary|Time to First Relapse Into Drinking|Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Days||Standard Deviation|Mean
1461973|NCT00764660|Secondary|Number of Lapses Into Any Drinking|An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Lapses||Standard Deviation|Mean
1461974|NCT00764660|Secondary|Number of Relapses Into Heavy Drinking|An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB).|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Relapses||Standard Deviation|Mean
1461975|NCT00764660|Secondary|Number of Drinks Per Drinking Day|The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with ‘day’ being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight.|12 weeks|The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure.|||Drinks||95% Confidence Interval|Least Squares Mean
1461990|NCT00764504|Primary|American Shoulder and Elbow Surgeons Shoulder Score|"The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:~[(10 – Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]"|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||Units on a scale||Standard Deviation|Mean
1466367|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 2|Subject Satisfaction - soft enough to conceal when deflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1461976|NCT00764660|Primary|Percentage of Heavy Drinking Days|"Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use.~A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol).~Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval."|12 weeks|The modified Intent-to-Treat (mITT) population consisted of all participants from the All-Participants-Treated (APT) population who had at least post randomization efficacy data for this outcome measure.|||Percentage of Days||95% Confidence Interval|Least Squares Mean
1461977|NCT00764517|Secondary|Scientific Correlates|"Perform scientific correlates to determine if SCR treatment a) is associated with global and gene specific changes in transcription of mRNAs and MiRNAs b) is acting as an inhibitor of DNA methylation c) is activating or silencing specific genes or miRNAs.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis."|Baseline|Data not collected and the outcome will never be analyzed.||||||
1461978|NCT00764517|Secondary|Contribution (if Any) of DNA Methylation/Histone Deacetylation|"Determine the contribution (if any) of DNA methylation/histone deacetylation to disease progression and/or response to SCR combination chemotherapy.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis."|Up to 2 years|Data not collected and the outcome will never be analyzed.||||||
1461979|NCT00764517|Secondary|Event-free Survival|"Time from treatment start until disease progression, death, or discontinuation of treatment for adverse event (toxicity)~Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant."|Up to 5 years||||Months||95% Confidence Interval|Median
1461980|NCT00764517|Secondary|Progression-free Survival|"Time from treatment start until disease progression or death.~Estimated using the Kaplan-Meier method. A logrank test will be used to compare progression-free survival between Group I and Group II. A p-value less that 0.05 will be considered statistically significant."|Up to 5 years||||Months||95% Confidence Interval|Median
1461981|NCT00764517|Primary|Tolerability of Treatment|Tolerability is determined to be the percentage of patients who completed the full duration of treatment (all 6 cycles) regardless of adverse event status. % tolerability shows the rate of patients that tolerated the treatment for the full duration.|6 months||||percentage of participants||95% Confidence Interval|Number
1461982|NCT00764517|Primary|Toxicities as Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Toxicity is determined percentage of patients that experienced an adverse event (AE) grade 3 or higher during the time frame, assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade refers to the severity of the AE increasing from Grade 1 to 5. Generally, Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; Grade 5 = Death related to AE.|6 months||||percentage of participants||95% Confidence Interval|Number
1461983|NCT00764517|Primary|Objective Response Rate|ORR defined as the percentage of patients who achieved a complete response (CR) or a partial response (PR). Assessed per the revised Cheson criteria. Response definitions per revised International Working Group Response Criteria. 95% confidence interval will be provided. Definitions: Complete response (CR) = disappearance of all evidence of disease; Partial response (PR) = regression of measurable disease and no new sites.|2 years||||percentage of participants||95% Confidence Interval|Number
1461984|NCT00764504|Primary|Safety Assessment|Number of device related adverse events and device failures at the 2 year time frame.|2-year|Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.|||adverse events|||Number
1461985|NCT00764504|Primary|Radiographic Failures|Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.|Post-operative, 3-month, 6-month, 1-year, 2-year|Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.|||participants|||Number
1461986|NCT00764504|Primary|"Neer's Limited Goals"|To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
1461987|NCT00764504|Primary|Have Surgery Again?|Subject satisfaction: subject's willingness to have surgery performed again if necessary.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
1461988|NCT00764504|Primary|Subject Satisfaction With Surgery|Each subject had a chance to rate their satisfaction with surgery at each study interval.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||participants|||Number
1461989|NCT00764504|Primary|Average Range of Motion|Physician's assessment of a subject's range of motion in degrees.|2-year|The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.|||Angle of Degrees of Shoulder Motion||Standard Deviation|Mean
1462045|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1504187|NCT00440830|Secondary|Systolic Blood Pressure|Systolic blood pressure reported in Millimeters of Mercury (mmHg)|1 hour after surgery|||||||
1461991|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score|PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score sums the scores from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461992|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score|PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score sums the score from all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461993|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score|PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461994|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score|PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461995|NCT00764478|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score|PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score sums the scores from all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461996|NCT00764478|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score|PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale sums the scores from all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461997|NCT00764478|Secondary|Change From Baseline in PANSS Positive Subscale Score|PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461998|NCT00764478|Secondary|Change From Baseline in PANSS Negative Subscale Score|PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums the scores from all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1461999|NCT00764478|Secondary|Change From Baseline in Positive And Negative Syndrome Scale (PANSS) Total Score|PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score sums the scores from all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1462000|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Depression Score|The CGI-BP-I depression is a score on a 7-point scale for assessing the change from preceding phase of depression symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I depression score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1462001|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Mania Score|The CGI-BP-I mania is a score on a 7-point scale for assessing the change from preceding phase of mania symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I mania score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1462002|NCT00764478|Secondary|Percentage of Participants Who Are CGI-BP Improvement (CGI-BP-I) Responders of Overall Bipolar Illness Score|The CGI-BP-I overall is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-BP-I overall score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. Missing data were imputed by LOCF. A CGI-BP-I responder had a score of 3 (minimally improved) or lower.|Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1462003|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Depression Score|The CGI-BP-S depression is a score that assesses the severity of the depression component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1462004|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Mania Score|The CGI-BP-S mania is a score that assesses the severity of the mania component of bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14, and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1462005|NCT00764478|Secondary|Change From Baseline in CGI-BP-S Overall Score at Day 2, Day 4, Day 7, Day 14|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1462006|NCT00764478|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS measures depression and consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score sums the scores from the 10 items, ranging from 0 to 60, with a higher numeric rating implying a greater degree of symptom severity. Missing data were imputed by LOCF. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 7 and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Score on a scale||Standard Error|Least Squares Mean
1462007|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 2, Day 4, Day 7, Day 14, Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a generalized linear mixed model (GLMM). Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 2, Day 4, Day 7, Day 14, Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1462008|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Remitters at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS remitters are defined as having a Y-MRS total score of 12 or lower.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one post-baseline measurement.|||Percentage of participants|||Number
1462046|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462009|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 2, Day 4, Day 7, Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 2, Day 4, Day 7, Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement, and had evaluable post-baseline measurement at timepoint.|||Percentage of participants|||Number
1462010|NCT00764478|Secondary|Change From Baseline in Y-MRS Total Score at Day 2, Day 4, Day 7 and Day 14|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 2, Day 4, Day 7 and Day 14|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1462011|NCT00764478|Secondary|Percentage of Participants Who Are Y-MRS Responders at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). Y-MRS responders are defined as having a >= 50% decrease from baseline in Y-MRS total score.|Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Percentage of participants|||Number
1462012|NCT00764478|Secondary|Change From Baseline in Clinical Global Impression – Bipolar Mania – Severity of Illness (CGI-BP-S) Overall Score at Day 21|The CGI-BP-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. The analysis is based on a MMRM model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement. One participant from the Placebo BID arm missed a baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1462013|NCT00764478|Primary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score at Day 21|Y-MRS consists of responses to the following 11 items: elevated mood, increased motor activity energy, sexual interest, sleep, language-thought disorder, appearance, insight, irritability, speech - rate and amount, content and disruptive-aggressive behavior. The scores from the 11 items are summed to give a total score ranging from 0 to 60, with a higher score indicating greater severity of symptoms. The analysis is based on a mixed model repeated measures (MMRM) model. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Day 21|Randomized participants who received at least one dose of trial medication and had at least one baseline and post-baseline measurement.|||Score on a scale||Standard Error|Least Squares Mean
1462014|NCT00764465|Primary|AUC: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng•h/mL||90% Confidence Interval|Mean
1462015|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma MVC PK Following Administration of RTV|Amprenavir (APV) is the active ingredient/ metabolite of Fosamprenavir (FPV). MVC minimum concentration (Cmin), maximum concentration (Cmax), and area under the plasma concentration-time curve (AUC), as determined from MVC concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when MVC 300mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when MVC 300mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F.|Day 7 of the MVC 300mg BID regimen and Day 14 of the MVC 300mg/FPV 1400mg BID, MVC 300mg/FPV 700mg/RTV 100mg BID, and MVC 300mg BID Plus FPV 1400mg/RTV 100mg QD regimens||||ng/mL||90% Confidence Interval|Mean
1462016|NCT00764465|Secondary|Number of Participants Who Experienced an Adverse Event|"Safety/tolerability data collected included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~MVC 300mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with MVC 300mg BID~FPV 700mg/RTV 100 mg BID combined with MVC 300mg BID~FPV 1400mg/RTV 100mg QD combined with MVC 300mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004"|Day 0 through Day 49||||participants|||Number
1495844|NCT00508482|Secondary|Time to the First Spontaneous Bowel Movement After the First Treatment||counting by hours|ITT analysis was used|||hours||Standard Deviation|Mean
1462017|NCT00764465|Primary|AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens||||ng•h/mL||90% Confidence Interval|Mean
1462018|NCT00764465|Primary|Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics ( PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent (Maraviroc) MVC 300mg BID.|Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV).|Day 14 of the FPV 1400mg BID, FPV 1400mg/MVC 300mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/MVC 300mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus MVC 300mg BID regimens||||ng/mL||90% Confidence Interval|Mean
1462019|NCT00764361|Secondary|Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)||baseline, week 4, week 10, week 20|||||||
1462020|NCT00764361|Primary|Number of Participants Without Adverse Events|Participants were monitored for 20 weeks during the study.|every 2 weeks||||participants|||Number
1462021|NCT00764322|Secondary|Patient Understanding of Pharmacogenomics|To examine patients' beliefs about how hypothetical genotype information would affect their perceived recurrence risk and benefits of tamoxifen therapy, participants were given experimentally manipulated 6 vignettes to describe hypothetical tamoxifen treatment (no or yes) and hypothetical genotype (EM, IM or PM). For each vignette, participants gave their perceived recurrence risk (RR; 0-100%)|baseline|Of 377 patients who were eligible to complete the survey, 320 patients completed the survey and 57 returned incomplete surveys|||percent chance of recurrence||Full Range|Mean
1462022|NCT00764322|Secondary|Change in Plasma Endoxifen Levels After an Increase in Tamoxifen Citrate Dose From 20 mg to 40 mg Daily in Patients With Poor-metabolizing Genotypes|The intrapatient change in median endoxifen levels were calculated between baseline and 4 months after the increase in dose of Tamoxifen from 20mg/day to 40 mg/day|Baseline and 4 months after dose increase|Analysis limited to only those subjects with the Poor Metabolizing (PM) genotype who were evaluable at baseline|||ng/mL||Inter-Quartile Range|Median
1462023|NCT00764322|Secondary|CYP2D6 Allele Frequencies and Endoxifen Levels Among African-American Women Taking Tamoxifen Citrate|Mean endoxifen levels by CYP2D6 genotype among African Americans. Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline.The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|baseline|Only participants who self-identified as African American were included in this analysis|||ng/ml||Full Range|Mean
1462024|NCT00764322|Secondary|Change in Median Endoxifen Concentrations to Determine Feasibility of Obtaining Pharmacogenomic Information From Patients in the Clinical Setting and Using it to Guide Changes in Therapy|If the key active tamoxifen metabolite, endoxifen, could be significantly increased by genotype-guided tamoxifen dosing in patients with intermediate CYP2D6 metabolism (by increasing tamoxifen dosing based on CYP2D6 genotype), then the study would be deemed feasible and the accrual expanded.|Baseline and 4 months after dose increase|This was based on the initial 119 subjects enrolled (based on initial sample size of 100) and of those, the 89 that completed 4 months of tamoxifen therapy|||ng/mL||Inter-Quartile Range|Median
1462025|NCT00764322|Secondary|Number of Participants With Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Stroke, and/or Endometrial Cancer|"The doubling of tamoxifen dose is defined as unacceptable (i.e., not tolerable) if the prevalence of Pulmonary embolism (PE), Deep vein thrombosis (DVT), stroke, or endometrial cancer, either individually or in any combination, is greater than 2%."|Approximately ten months from registration to last follow-up|Incidence of unacceptable adverse events among all patients who completed study|||Participants|||Count of Participants
1462026|NCT00764322|Primary|Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes|Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.|4 months|Baseline measurements are reported on all 353 subjects, while the 4 month levels are reported only for patients who completed 4 months of treatment|||ng/mL||Standard Deviation|Mean
1462027|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Blood Chemistry Per (NCI-CTCAE) Version 3.0 Grade (GR)|GR0=normal,1=mild,2=moderate,3=severe,4=life-threatening. ALP(U/L) GR0:40-135,GR1:>135-337; ALT(U/L) GR0:0-47,GR1:>47-117; AST(U/L) GR0:0-37,GR1:>37-93; High(↑) Calcium(mg/dL) GR0:8.4-10.2,GR1:>10.2-11.5; Low(↓) Calcium(mg/dL) GR0:8.4-10.2,GR1:<8.4-8.0,GR2:7.0-<8.0; CK(U/L) GR0:24-195,GR1:>195-488, GR2:>488-975; Creatinine(mg/dL) GR0:0.6-1.4,GR1:>1.4-2.1,GR2:>2.1-4.2; ↑Potassium(mEq/L) GR0:3.6-5.2,GR1:>5.2-5.5,GR2:>5.5-6.0; ↑Sodium(mEq/L) GR0:134-146; ↓Sodium(mEq/L) GR0:134-146,GR1:<134-130; Inorganic Phosphorus(mg/dL) GR0:2.4-4.9,GR2:≥2.0-<2.5; Total Bilirubin(mg/dL) GR0:0-1.1,GR1:>1.1-2.75.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||participants|||Number
1462028|NCT00764309|Primary|Laboratory Test Results Summary of Toxicity: Hematology|Toxicity was graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. (Grade (GR)0=normal, GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening). Granulocyte count (x 10^9 /L), GR1: ≥1.0 - <1.5, GR2: ≥0.5 - <1.0; Hemoglobin (g/dL), GR0: 13-17, GR1: <13 - 10.0 , GR2: 8.0 - <10.0, GR3: 6.5 - <8.0; Platelet count (x 10^9 /L) GR0: 150-400, GR2: ≥50.0 - <75.0; Leukocyte count (x 10^9 /L ), GR0: 3.5-11.1, GR2: 2.0 - <3.0.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||participants|||Number
1462029|NCT00764309|Primary|Reasons for Discontinuation of Study Treatment|"Participants who discontinued the study due to any AEs were recorded.~Significant drug-related discontinuations were those SAEs recorded on the SAE case report forms with relationship to study drug of related or missing and action taken regarding study drug of discontinued or missing."|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||Participants|||Number
1462030|NCT00764309|Primary|Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), or Adverse Events (AEs)|AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.|From start of study drug therapy up to 30 days after the last dose. The duration of dasatinib dosing in this study was up to 2 years|All treated participants.|||Participants|||Number
1462031|NCT00763971|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.|Up to 7 weeks|Safety Population|||participants|||Number
1462032|NCT00763971|Secondary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks|The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.|Baseline and up to 7 weeks|Safety Population defined as all subjects who took at least 1 dose of investigational product.|||Scores on a scale||Standard Deviation|Mean
1462033|NCT00763971|Secondary|Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks|The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1462034|NCT00763971|Secondary|Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks|The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.|Baseline and up to 7 weeks|FAS|||T-scores||Standard Error|Least Squares Mean
1462035|NCT00763971|Secondary|Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks|HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Deviation|Mean
1462036|NCT00763971|Secondary|Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks|The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.|Baseline and up to 7 weeks|FAS|||Scores on a scale||Standard Error|Least Squares Mean
1462037|NCT00763971|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 7 weeks|FAS|||percentage of participants|||Number
1462038|NCT00763971|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.|Baseline and up to 7 weeks|Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.|||Scores on a scale||Standard Error|Least Squares Mean
1462039|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 24.|Number of participants with positive opiate urine sample at the 24 week follow-up.|24 weeks|All subjects were included in the analysis population as intent to treat.|||participants|||Number
1462040|NCT00763958|Secondary|Number of Participants Who Enroll in the Study.|To determine the number of participants who enroll in the study during the time of recruitment.|up to 24 months||||participants|||Number
1462041|NCT00763958|Primary|Opiate Positive Urines With Missing Urines Coded as Positive at Week 12.|Number of participants with positive opiate urine samples at 12 weeks of treatment.|12 weeks|All subjects were included in the analysis population as intent to treat.|||participants|||Number
1462042|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462043|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462044|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462068|NCT00763867|Other Pre-specified|Collagen Type I (CITP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ug/L||Standard Deviation|Mean
1462048|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462049|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462050|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462051|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462052|NCT00763919|Secondary|Change in Perception of Mental Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived mental health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462053|NCT00763919|Secondary|Change in Perception of Physical Health as Measured by the 12-item Short Form Health Survey (SF-12)|The minimum score is 1 and the maximum score is 99. A higher score implies higher perceived physical health.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462054|NCT00763919|Secondary|Change in Functional Status as Measured by the Global Assessment of Functioning (GAF) Scale|The minimum score is 1 and the maximum score is 100. A higher score implies higher functioning.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462055|NCT00763919|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP)|The minimum score is 1 and the maximum score is 7. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462056|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum score is 18 and the maximum score is 126. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462057|NCT00763919|Secondary|Change in Symptoms of Bipolar Disorder as Measured by the Young Mania Rating Scale (YMRS)|The minimum score is 0 and the maximum score is 60. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462058|NCT00763919|Secondary|Change in Depression as Measured by the Hamilton Rating Scale for Depression (HAM-D)|The minimum score is 0 and the maximum score is 52. A higher score implies a worse condition.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462059|NCT00763919|Secondary|Change in Attitude as Measured by the Rating of Medication Influences (ROMI)|The minimum score is 0 and the maximum score is 10. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462060|NCT00763919|Secondary|Change in Attitude as Measured by the Attitude Toward Mood Stabilizers Questionnaire (AMSQ)|The AMSQ is a modification of the Lithium Attitudes Questionnaire. The minimum score is 0 and the maximum score is 19. A higher score implies a poorer attitude.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462061|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 3 months|Number of participants for analysis was based on all available data at the three month time point.|||units on a scale||Standard Error|Mean
1462062|NCT00763919|Primary|Change in Treatment Adherence as Measured by the Morisky Scale|The minimum score is 0 and the maximum score is 4. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462063|NCT00763919|Primary|Change in Treatment Adherence Within the Past Week as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462064|NCT00763919|Primary|Change in Treatment Adherence Within the Past Month as Measured by the Tablet Routines Questionnaire|The minimum score is 0 and the maximum score is 100. A higher score implies poorer treatment adherence.|baseline and 6 months|Number of participants for analysis was based on all available data at the six month time point.|||units on a scale||Standard Error|Mean
1462065|NCT00763867|Other Pre-specified|Furosemide-Equivalent Dose||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg||Standard Deviation|Mean
1462066|NCT00763867|Other Pre-specified|Galectin 3||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ng/mL||Standard Deviation|Mean
1462067|NCT00763867|Other Pre-specified|Cyclic Guanosine Monophosphate (cGMP)||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||pmol/mL||Standard Deviation|Mean
1504188|NCT00440830|Secondary|Pain Medication Used|Pain medication used after surgery in morphine equivalents|5 days|||||||
1462077|NCT00763867|Other Pre-specified|Best Available Glomerular Filtration Rate (GFR)|Best available=local lab results when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/min/1.73m^2||Standard Deviation|Mean
1462078|NCT00763867|Other Pre-specified|Best Available Creatinine|Best available=local lab results only when core lab results not available|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mg/dL||Standard Deviation|Mean
1462079|NCT00763867|Other Pre-specified|ECHO Pulmonary Artery Systolic Pressure|A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mmHg||Standard Deviation|Mean
1462080|NCT00763867|Other Pre-specified|MRI Aortic Distensibility|An increase in Aortic Distensibility is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||cm^2*dyne-1||Standard Deviation|Mean
1462081|NCT00763867|Other Pre-specified|MRI Aortic Thickness|A decrease in Aortic Thickness is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mm||Standard Deviation|Mean
1462082|NCT00763867|Other Pre-specified|MRI Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Woods units||Standard Deviation|Mean
1462083|NCT00763867|Other Pre-specified|MRI Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Farads-1||Standard Deviation|Mean
1462084|NCT00763867|Other Pre-specified|ECHO Systemic Vascular Resistance|A decrease in Systemic Vascular Resistance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Woods units||Standard Deviation|Mean
1462085|NCT00763867|Other Pre-specified|ECHO Effective Arterial Elastance|A decrease in Effective Arterial Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||Farads-1||Standard Deviation|Mean
1462086|NCT00763867|Other Pre-specified|Lateral Filling Pressure|A decrease in lateral filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1462087|NCT00763867|Other Pre-specified|Medial Filling Pressure|A decrease in medial filling pressure is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1462088|NCT00763867|Other Pre-specified|Lateral Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1462089|NCT00763867|Other Pre-specified|Medial Left Ventricular Relaxation|An increase in Left Ventricular relaxation is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||m/sec||Standard Deviation|Mean
1462090|NCT00763867|Other Pre-specified|Lateral Diastolic Elastance|A decrease in Lateral Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||(m/sec)/cc||Standard Deviation|Mean
1462091|NCT00763867|Other Pre-specified|Medial Diastolic Elastance|A decrease in Medial Diastolic Elastance is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||(m/sec)/cc||Standard Deviation|Mean
1462092|NCT00763867|Other Pre-specified|Echocardiogram Left Ventricular Mass|A decrease in Left Ventricular Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm||Standard Deviation|Mean
1462093|NCT00763867|Other Pre-specified|MRI Left Ventricular Ejection Fraction (LVEF)|An increase in LVEF is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||percentage of volume||Standard Deviation|Mean
1462094|NCT00763867|Other Pre-specified|MRI Left Ventricular End Systolic Volume Index|An increase in Left Ventricular End Systolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/m^2||Standard Deviation|Mean
1462095|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume Index|An increase in Left Ventricular End Diastolic Volume Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL/m^2||Standard Deviation|Mean
1462096|NCT00763867|Other Pre-specified|MRI Left Ventricular End Diastolic Volume|An increase in Left Ventricular End Diastolic Volume is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||mL||Standard Deviation|Mean
1462097|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass Index|A decrease in Left Ventricular Mass Index is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm/m^2||Standard Deviation|Mean
1462098|NCT00763867|Other Pre-specified|MRI Left Ventricular Mass|A decrease in LV Mass is considered an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||gm||Standard Deviation|Mean
1462220|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462099|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire|The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1462100|NCT00763867|Secondary|Minnesota Living With Heart Failure Questionnaire (MLWHFQ)|"The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.~Total score: 0 – 105 Physical subscore: 0 – 40 Emotional subscore: 0 – 25"|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1462101|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1462102|NCT00763867|Secondary|Ventilatory Anaerobic Threshold|To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1462103|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||minutes||Standard Deviation|Mean
1462104|NCT00763867|Secondary|Cardiopulmonary Exercise Test (CPET) Duration|To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||minutes||Standard Deviation|Mean
1462105|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 minute walk distance|Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||meters||Standard Deviation|Mean
1462106|NCT00763867|Secondary|Composite Score Reflective of Clinical Status|"Participants ranked sequentially with ranking stratified in one of three tiers based on:~Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.~Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.~Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)~The use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)"|Measured at Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||units on a scale||Standard Deviation|Mean
1462107|NCT00763867|Secondary|Exercise Capacity as Determined by Walk Distance|6 Minute Walk Distance|Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||meters||Standard Deviation|Mean
1462108|NCT00763867|Secondary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 12|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1462109|NCT00763867|Primary|Exercise Capacity, as Determined by Peak Oxygen Uptake||Change from Baseline to Week 24|Participants analyzed consisted of those participants who had the endpoint data available to be derived.|||ml/min/kg||Standard Deviation|Mean
1462110|NCT00763815|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 132 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1462111|NCT00763815|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1462261|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462112|NCT00763815|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1462113|NCT00763815|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (fasting plasma glucose [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
1462114|NCT00763815|Secondary|Percentage of Patients With HbA1c Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1462115|NCT00763815|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1462116|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPI assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1462117|NCT00763815|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1462118|NCT00763815|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1462119|NCT00763815|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1462120|NCT00763750|Primary|Number of Patients Assessed for Toxicity According to CTC Version 3.0||Throughout the entire study until patient is removed from study an average of 6 weeks||||participants|||Number
1462150|NCT00763360|Primary|Endothelial Cell Count Change From Baseline|Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.|one month|Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.|||Percent change from baseline||Standard Deviation|Mean
1462121|NCT00763698|Primary|Left Ventricular Bipolar Pacing Capture Threshold (Volts)|The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint.|3 months|This effectiveness endpoint was carried out on the first 16 patients who had a LV lead bipolar pacing capture threshold measurement at 3 months at 0.5 ms pulse width. This patient cohort is referred to as the “Primary Pacing Capture Threshold Patient Cohort”.|||volts||Standard Deviation|Mean
1462122|NCT00763698|Primary|Percentage of Successful Left Ventricular Lead Implants|Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator.|3 months|All patients with an implant or attempted implant were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1462123|NCT00763698|Primary|Freedom From Left Ventricular Lead-related Complications|A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported.|3 months|Analysis was conducted on the 81 patients with a successful left ventricular lead implant.|||percent of participants||95% Confidence Interval|Number
1462124|NCT00763490|Secondary|Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)|"The percentage of patients with acute GVHD (Grade II-IV) was determined at 100 days. Patients were followed up to 5 years and the percentage of patients that developed chronic GVHD at the end of the study was tabulated.~Acute GVHD is staged and graded (grade 0-IV, where grade 0 is no involvement and involvement increases by grade) by the number and extent of organ involvement. Patients can have involvement of three organs: skin (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea)."|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
1462125|NCT00763490|Secondary|Cumulative Incidence of Neutrophil and Platelet Engraftment|The failure to achieve a neutrophil count > 500/uL or a platelet count >30.0 x 10e9 /L within 35 days of the stem cell infusion will be defined as primary engraftment failure.|Day 35||||percentage of participants||95% Confidence Interval|Number
1462126|NCT00763490|Secondary|Percentage of Patients Alive at the End of the Trial|Event Free Survival (EFS) was determined. Patients were followed up to 5 years (median time of 2.35 years).|5 Years||||percentage of patients||95% Confidence Interval|Number
1462127|NCT00763490|Primary|Percentage of Participants Alive at 1 Year After Transplant|One-year survival rate after transplant|1 year||||percentage of participants||95% Confidence Interval|Number
1462128|NCT00763451|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 112 weeks|"Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||participants|||Number
1462129|NCT00763451|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1462130|NCT00763451|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-measured plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|"mITT population. The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1462131|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1462176|NCT00763061|Secondary|Mean IOP Change From Baseline at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 9 AM||||mmHg||Standard Deviation|Mean
1462132|NCT00763451|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|"mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||percentage of participants|||Number
1462133|NCT00763451|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|||kilogram||Standard Error|Least Squares Mean
1462134|NCT00763451|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|"mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.The Placebo (Two-step Titration)andPlacebo (One-step Titration)Arms/Groups were combined as pre-specified in the study protocol"|||mmol/L||Standard Error|Least Squares Mean
1462135|NCT00763451|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|"Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.~The Placebo (Two-step Titration) and Placebo (One-step Titration) Arms/Groups were combined as pre-specified in the study protocol"|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1462136|NCT00763412|Secondary|C-Peptide||2 year||||pg/ml||Full Range|Mean
1462137|NCT00763412|Secondary|FEV 1|% of lung function|2 year/end of study||||% lung function||Full Range|Mean
1462138|NCT00763412|Secondary|Tanner Stage|Puberty scale measuring 1-5, 1 being least development, 5 being most development.|2 year/end of study||||units on a scale||Full Range|Mean
1462139|NCT00763412|Secondary|Wt Z Score||2 year/end of study||||Z score||Full Range|Mean
1462140|NCT00763412|Secondary|Inflammatory Markers||2 year/end of study||||pg/ml||Full Range|Mean
1462141|NCT00763412|Secondary|Glucose Tolerance|We completed the OGTT at the 2 year/end of study visit.|2-year||||mg/dl||Full Range|Mean
1462142|NCT00763412|Primary|CRP||2 year/end of study||||mg/L||Full Range|Mean
1462143|NCT00763412|Primary|Body Composition|Reporting % of Fat and Lean body mass|2 year/end of study||||% body mass||Full Range|Mean
1462144|NCT00763412|Primary|BMI||2 year/end of study||||Kg/m^2||Full Range|Mean
1462145|NCT00763386|Secondary|Return to Function (RtF) Via Knee Society Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|6 Weeks to 2 Years Post-op, based on on the intervals listed||||units on a scale||Standard Deviation|Mean
1462146|NCT00763386|Primary|Postoperative Range of Motion (ROM)|Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension.|6 Weeks to 2 Years Post-op, based on on the intervals listed|Analysis was determined by calculating the measurements of the enrolled cases who completed the stated visit interval.|||degrees||Standard Deviation|Mean
1462147|NCT00763360|Secondary|Corneal Clarity|Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.|2 weeks|Data from subjects for whom this evaluation was not performed is not included in this analysis.|||units on a scale|||Number
1462148|NCT00763360|Secondary|Change in Corneal Thickness|Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.|1 month|Subjects that did not have both baseline and 1 month values were not included in this analysis.|||millimeters||Standard Deviation|Median
1462149|NCT00763360|Primary|Investigator Reported Space Maintenance|"Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: Full Chamber Maintained, Working Space Maintained, Shallow, Flat. Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion."|During surgical procedure||||participants|||Number
1463567|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1462151|NCT00763321|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant’s sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.|||scores on a scale||Standard Error|Least Squares Mean
1462152|NCT00763321|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).|||scores on a scale||Standard Error|Least Squares Mean
1462153|NCT00763282|Secondary|Mean Number of Skin-related Admissions|Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early reporting of skin breakdown.|Discharge to end of study (6 months)|Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)|||admissions/participant||Standard Deviation|Mean
1462154|NCT00763282|Primary|Skin Status|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|Admission (Baseline), 3 months, 6 months||||participants|||Number
1462155|NCT00763282|Primary|Any Skin Worsening|Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.|6 months||||participants|||Number
1462156|NCT00763282|Primary|Skin Behavior Change|"Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms.~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months||||% Change||Standard Deviation|Mean
1462157|NCT00763282|Primary|Percent of Possible Self-Reported Skin Care Behaviors|"Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline).~The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge."|Admission (Baseline), 3 months, 6 months||||% of Possible Self-Reported Behaviors||Standard Deviation|Mean
1462158|NCT00763269|Secondary|Air Blast Hypersensitivity (8 Week)|"Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:0No subject response to stimulus1responds but will continue2responds and moves or requests discontinuation3Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth."|8 weeks||||units on a scale||Standard Deviation|Mean
1462159|NCT00763269|Secondary|Air Blast Hypersensitivity (4 Week)|Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale.This analog scale scores for the tooth is 0,1,2 or 3:“0”No subject response to stimulus“1”responds but will continue“2”responds and moves or requests discontinuation“3”Painful response to stimulus, discontinuation requested. The lower the score, the lower the hypersensitivity.Scores per study subject are recorded as mean scores of two hypersensitive teeth.|4 weeks||||units on a scale||Standard Deviation|Mean
1462160|NCT00763269|Primary|Hypersensitivity Tactile (Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|8 weeks||||Units on a scale||Standard Deviation|Mean
1462161|NCT00763269|Primary|Hypersensitivity Tactile(Yeaple Probe)|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 50 grams of force are applied to hypersensitive tooth until pain elicited. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. For Tactile Hypersensitivity: The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Hypersensitivity scores on a per study subject basis are recorded as mean scores of two hypersensitive teeth|4 weeks||||units on a scale||Standard Deviation|Mean
1462219|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462162|NCT00763256|Primary|P. Gingivalis|Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.|12 months||||Pg/ng DNA||Inter-Quartile Range|Median
1462163|NCT00763256|Primary|Gingivitis Score (GI)|"Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)"|12 months||||Units on a scale||Standard Deviation|Mean
1462164|NCT00763256|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||nmol/L||Standard Deviation|Mean
1462165|NCT00763256|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||mg/L||Standard Deviation|Mean
1462166|NCT00763256|Primary|HbA1c Levels in Blood|Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).|12 months||||Percentage||Standard Deviation|Mean
1462167|NCT00763243|Primary|Behavior Rating Inventory of Executive Function (BRIEF) - Working Memory Subscale Raw Score (Construct Measured: Behavioral Attention-Concentration and Working Memory)|"The BRIEF is a parent-report questionnaire of executive functioning behaviors in children. For each item, parents rate whether the child engages in the behavior never (=1), sometimes (=2), or often (=3). Raw scores for subscales are sums of item scores. The Working Memory subscale consists of 10 items asking about attention, concentration, and active controlled memory. Working Memory subscale raw scores are measures of attention, concentration, and working memory, and range from 10 to 30. Higher raw scores indicate more problems with attention, concentration, and working memory."|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
1462168|NCT00763243|Primary|Spatial Span Total Raw Score (Construct Measured: Visuospatial Short-Term/Working Memory)|This is a measure of memory for sequential spatial locations (forward and backward), based on the subject touching one of 10 blocks in the same sequence (forward) or in the reverse sequence (backward) that they were touched by the examiner. This subtest is based on the WISC-IV-Integrated Spatial Span subtest. The examiner points to blocks on a board, sequentially, starting with a sequence of two blocks (locations), which increase by 1 block (location) after 2 sequences are presented at each span length. The test is discontinued when 2 items are missed at the same spatial span length. Raw score is the number of items (complete sequences) answered correctly. The Spatial Span test is a measure of visuospatial short-term/working memory. Scores range from 0 to 28, with higher scores indicating better visuospatial short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
1462169|NCT00763243|Primary|Digit Span Total Raw Score (Construct Measured: Verbal Short-Term/Working Memory)|This is a measure of digit span forward and digit span backward based on the WISC-III Digit span subtest. Subjects are presented with sequences of single digits, starting with 2 digits, which increase by 1 digit after 2 sequences are presented at each digit length. The test is discontinued when 2 items are missed at the same digit length. Raw score is the number of items (digit sequences) answered correctly. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.|Administered at Screening Visit, Pretraining Visit (2-5 weeks later), Posttraining Visit (5 weeks after Pretraining Visit), 1 month follow-up visit (1 month after Posttraining Visit), and 6 month follow-up visit (6 months after Posttraining Visit)||||Scores on a scale||Standard Deviation|Mean
1462170|NCT00763139|Secondary|ESR|sed rate|baseline and after 8 weeks on either placebo or pioglitazone||||mm/hr||Standard Deviation|Mean
1462171|NCT00763139|Secondary|C-reactive Protein (CRP)||Measured after 8 weeks of treatment||||mg/dl||Standard Deviation|Mean
1462172|NCT00763139|Primary|Homeostasis Model Assessment (HOMA) for Insulin Sensitivity|Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose * Insulin/22/5|Measured after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
1462173|NCT00763139|Primary|Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)|A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH|Measured after 8 weeks of treatment||||units on a scale||Standard Deviation|Mean
1462174|NCT00763061|Secondary|Mean IOP Change at 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|Baseline to Week 12 - at 4 PM||||mmHg||Standard Deviation|Mean
1462175|NCT00763061|Primary|Week 12 - Mean IOP At 4 PM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At the 4 PM time point for the patient's worse eye.||||mmHg||Standard Deviation|Mean
1462177|NCT00763061|Primary|Mean Intraocular Pressure (IOP) at 9 AM|Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.|At Week 12 - At the 9 AM time point for the patient's worse eye.||||millimeters mercury (mmHg)||Standard Deviation|Mean
1462178|NCT00763048|Primary|Metabolite Associated With Inflammation (Xanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462179|NCT00763048|Primary|Metabolite Associated With Inflammation (Putrescine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462180|NCT00763048|Primary|Metabolite Associated With Inflammation (Phenylalanine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462181|NCT00763048|Primary|Metabolite Associated With Inflammation (Lysine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462182|NCT00763048|Primary|Metabolite Associated With Inflammation (Leucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462183|NCT00763048|Primary|Metabolite Associated With Inflammation (Isoleucine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462184|NCT00763048|Primary|Metabolite Associated With Inflammation (Inosine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462185|NCT00763048|Primary|Metabolite Associated With Inflammation (Hypoxanthine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462186|NCT00763048|Primary|Metabolite Associated With Inflammation (Choline)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462187|NCT00763048|Primary|Metabolite Associated With Inflammation (Cadaverine)|One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.|6 weeks||||ion count||Standard Deviation|Mean
1462188|NCT00763009|Secondary|To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.||6-12 months|The study was terminated due to poor enrollment||||||
1462189|NCT00763009|Primary|To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.|To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling|6-12 months|"All patients responded. Function and Expression of the Transporter were therefore not performed.~The study was terminated due to poor enrollment"||||||
1462190|NCT00762996|Secondary|Lens Comfort|A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable|1 week||||Units on a scale||Standard Error|Least Squares Mean
1462191|NCT00762996|Primary|Distance Visual Acuity|logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|1 week||||logMar||Standard Error|Least Squares Mean
1462192|NCT00762970|Primary|Axial Length (Axial Elongation)|Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||millimeter (mm)|eyes|Standard Deviation|Mean
1462193|NCT00762970|Primary|Spherical Equivalent Refraction|Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||diopter (D)|eyes|Standard Deviation|Mean
1462194|NCT00762931|Secondary|Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).|"An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes).~Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1.~The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%."|60 minutes|Safety population. 1 subject result missing due to no stimulation performed.|||Participants|||Count of Participants
1462195|NCT00762931|Primary|Safety- Number of Participants With Adverse Events|Safety- Number of participants that reported Adverse Events|2 weeks|Safety|||Participants|||Count of Participants
1462196|NCT00762892|Secondary|Change From Baseline in Homocysteine at 6 Months||Baseline and 48 weeks||||umol/L||Standard Deviation|Mean
1462197|NCT00762892|Secondary|Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks||Baseline and 48 weeks||||pg/mL||Standard Deviation|Mean
1462198|NCT00762892|Primary|Change From Baseline in Log HIV Viral Load at 48 Weeks||Baseline and 48 weeks||||copies/mL||Standard Deviation|Mean
1462199|NCT00762892|Secondary|Change From Baseline in Lipids at 48 Weeks||Baseline and 48 weeks||||mg/dL||Standard Deviation|Mean
1462200|NCT00762892|Primary|Change From Baseline in CD4 Count at 48 Weeks||Baseline and 48 weeks||||cells/uL||Standard Deviation|Mean
1462201|NCT00762853|Primary|Triclosan Concentration in Dental Plaque|Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.|12 hours||||ppm levels of triclosan||Standard Deviation|Mean
1462202|NCT00762788|Primary|Incidence of Adverse Events|Occurrence of any Adverse Event by study lens. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.|||percentage of participants||95% Confidence Interval|Number
1462203|NCT00762788|Primary|Incidence of Corneal Infiltrative Events|Extended wear is defined as 7 days, 6 nights of lens wear, weekly replacement of lenses. Incidence was calculated as the number of subjects with event divided by the total number of subjects assigned to that lens type.|52 weeks|Subjects who were enrolled and dispensed lenses.|||percentage of participants||95% Confidence Interval|Number
1462204|NCT00762762|Primary|TNF-α (Tumor Necrosis Factor - Alpha)|Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.|12 months||||pg/ml||Standard Deviation|Mean
1462205|NCT00762762|Primary|IL-6 (Interleukin - 6)|Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)|12 months||||pg/ml||Standard Deviation|Mean
1462206|NCT00762762|Primary|C-Peptide|C-Peptide levels in blood indicate whether or not a person is producing insulin|12 months||||ng/ml||Standard Deviation|Mean
1462207|NCT00762762|Primary|High Sensitivity CRP (C-Reactive Protein)|CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.|12 months||||µg/ml||Standard Deviation|Mean
1462208|NCT00762762|Primary|HbA1c Levels in Blood|Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.|12 months||||percentage of HbA1c levels||Standard Deviation|Mean
1462209|NCT00762723|Primary|Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)|- Fusion Assessment|Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months|Data not analyzed because study was stopped due to slow enrollment.||||||
1462210|NCT00762645|Secondary|Number of Patients With Peripheral Anterior Synechiae (PAS)||Week 12 Visit||||Participants|||Number
1462211|NCT00762645|Primary|Mean Intraocular Pressure (IOP)||4PM at Week 12 Visit||||millimeters mercury (mm Hg)||Standard Deviation|Mean
1462212|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462213|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462214|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462215|NCT00762619|Primary|Veillonella sp.(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462216|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462217|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)- Dental Implants|14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462218|NCT00762619|Primary|T.Forsythia (DNA Probe Analysis)-Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462221|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462222|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462223|NCT00762619|Primary|Streptococci (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462224|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462225|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462226|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462227|NCT00762619|Primary|Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462228|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462229|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462230|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462231|NCT00762619|Primary|P.Melaninogenica (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462232|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462233|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462234|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462235|NCT00762619|Primary|P.Intermedia (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462236|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462237|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462238|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462239|NCT00762619|Primary|P.Gingivalis (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462240|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462241|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462242|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462243|NCT00762619|Primary|Neissera sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462244|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462245|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Dental Implants|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462246|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462247|NCT00762619|Primary|F.Nucleatum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462248|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462249|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462250|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462251|NCT00762619|Primary|E.Saburreum (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462252|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462253|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462254|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462255|NCT00762619|Primary|E.Corrodens (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462256|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462257|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462258|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462259|NCT00762619|Primary|Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462260|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1466368|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1462262|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462263|NCT00762619|Primary|C.Rectus (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462264|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462265|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant|14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|3 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462266|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).|6 months||||Log cfu (colony forming units)||Standard Error|Least Squares Mean
1462267|NCT00762619|Primary|A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth|14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).|3 months||||Log cfu (Colony Forming Units)||Standard Error|Least Squares Mean
1462268|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|6 months||||Units on a scale||Standard Deviation|Mean
1462269|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants|Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.|3 months||||Units on a scale||Standard Deviation|Mean
1462270|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.|6 months||||Units on a scale||Standard Deviation|Mean
1462271|NCT00762619|Primary|Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth|Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.|3 months||||Units on a scale||Standard Deviation|Mean
1462272|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months||||units on a scale||Standard Deviation|Mean
1462273|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI)- Dental Implants|Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months||||units on a scale||Standard Deviation|Mean
1462274|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|6 months||||units on a scale||Standard Deviation|Mean
1462275|NCT00762619|Primary|Löe-Silness Gingival Index Score (GI) - Natural Teeth|Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation–slight change in color and little change in texture,2 = Moderate inflammation–moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation–marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.|3 months||||units on a scale||Standard Deviation|Mean
1462276|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months||||units on a scale||Standard Deviation|Mean
1462277|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Dental Implants|"Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months||||units on a scale||Standard Deviation|Mean
1462278|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|6 months||||units on a scale||Standard Deviation|Mean
1462279|NCT00762619|Primary|Mombelli Plaque Index (mPI) for Natural Teeth|"Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,~1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth."|3 months||||units on a scale||Standard Deviation|Mean
1462280|NCT00762606|Secondary|Corneal Astigmatism|Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.|3 months after surgery||||Diopters||Standard Deviation|Mean
1462281|NCT00762606|Primary|Posterior Capsule Opacification Evaluation|The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.|12 months after surgery||||participants|||Number
1462282|NCT00762528|Primary|8-iso-prostaglandinF2α (8-iso-PGF2α)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1462283|NCT00762528|Primary|Nuclear Factor Kappa B Ligand (RANK-L)|Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1462284|NCT00762528|Primary|Interleukin-6 (IL-6)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1462285|NCT00762528|Secondary|Bleeding on Probing (BOP)|Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing.|29 days||||Units on a scale||Standard Deviation|Mean
1462286|NCT00762528|Secondary|Dental Plaque Index (PI)|measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces.|29 days||||Units on a scale||Standard Deviation|Mean
1462287|NCT00762528|Primary|Interleukin - 1 Beta (IL-ß)|Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1462288|NCT00762528|Primary|Prostaglandin E2 (PGE2)|Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.|29 days||||pg/µl||Standard Deviation|Log Mean
1462289|NCT00762528|Primary|Gingival Index (GI)|"Gingival Index(GI)recorded on scale of 0-3 detailed below:~0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed"|29 days||||units on a scale||Standard Deviation|Mean
1462290|NCT00762515|Secondary|Control Gingivitis in Adults|Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).|6 weeks||||Units on a scale||Standard Deviation|Mean
1462291|NCT00762515|Primary|Control Established Plaque in Adults|Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.|6 weeks||||Units on a scale||Standard Deviation|Mean
1462292|NCT00762502|Primary|Tarsal Roughness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1463568|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1462293|NCT00762502|Primary|Bulbar Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1462294|NCT00762502|Primary|Limbal Redness|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1462295|NCT00762502|Primary|Corneal Staining|Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.|at 3 months of lens wear (period 1)|Subjects analyzed included those who were enrolled, randomized to a study arm, and completed the study at 3 months, (n=77). Subjects were analyzed by device therefore the subjects from the contralateral arm were counted once in EITHER of the device arms for analysis.|||units on a scale|eyes|Standard Deviation|Mean
1462296|NCT00762476|Secondary|Rhinovirus-associated Colds|The incidence of rhinovirus-associated cold illnesses.|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||RV-associated cold illnesses per 100 sub|||Number
1462297|NCT00762476|Secondary|Rhinovirus Infections.|The incidence of rhinovirus infections|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||rhinovirus infections per 100 subjects|||Number
1462298|NCT00762476|Primary|The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.|Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group|10 weeks|All efficacy analyses were performed on the intent-to-treat (ITT).The ITT population included all enrolled subjects who received study treatment.|||cold illnesses per 100 subjects|||Number
1462299|NCT00762463|Secondary|Paracetamol Tablets Taken Per Day by Participant|Calculated as the total number of paracetamol tablets taken divided by days of exposure in the study.|Week 6|FAS|||tablets per day||Standard Deviation|Mean
1462300|NCT00762463|Secondary|Percentage of Days With Concomitant Administration of Paracetamol|Calculated as days on rescue medication divided by days of exposure in the study at the end of Week 6.|Week 6|FAS|||percentage of days||Standard Deviation|Mean
1462301|NCT00762463|Secondary|Percentage of Participants With Concomitant Use of Paracetamol|Percentage of participants who concomitantly took at least 1 paracetamol tablet as rescue medication at Week 6|Week 6|FAS|||percentage of participants|||Number
1462302|NCT00762463|Secondary|Change From Baseline in CRP at Week 12|CRP was a marker of inflammation. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mg/L||Standard Deviation|Mean
1462303|NCT00762463|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 6|C-Reactive Protein (CRP) was a marker of inflammation, measured in milligram per liter (mg/L). Change from baseline <0 indicated improvement.|Baseline, 6 Weeks|FAS|||mg/L||Standard Error|Least Squares Mean
1462304|NCT00762463|Secondary|Change From Baseline in ESR at Week 12|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. Lower values indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm/h||Standard Deviation|Mean
1462305|NCT00762463|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 6|Erythrocyte Sedimentation Rate (ESR) was a laboratory test that providee a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h). Change from baseline <0 indicated improvement.|Baseline, Week 6|FAS|||mm/h||Standard Error|Least Squares Mean
1462306|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Week 12|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Higher scores indicate better health. Change from baseline greater than (>) 0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||cm||Standard Deviation|Mean
1462307|NCT00762463|Secondary|Change From Baseline in Chest Expansion at Weeks 2, 4, and 6|Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). The better of 2 tries was recorded. Change from baseline greater than (>) 0 represented improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||cm||Standard Error|Least Squares Mean
1462308|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Week 12|Fingertips to floor distance measured in cm from the tip of the fingers to the floor with participant standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Lower scores indicated better health. Change from baseline <0 represented improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||cm||Standard Deviation|Mean
1462309|NCT00762463|Secondary|Change From Baseline in Fingertips to Floor Distance at Weeks 2, 4, and 6|Fingertips to floor distance measured in centimeter (cm) from the tip of the fingers to the floor with participants standing erect and feet together, knees as straight as possible, then bending forward as far as possible with fingers reaching towards the floor. The better of 2 tries was recorded. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||cm||Standard Error|Least Squares Mean
1466369|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1462310|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Week 12|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Lower scores indicated less pain. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1462311|NCT00762463|Secondary|Change From Baseline in Nocturnal Pain at Weeks 2, 4, and 6|"100-mm VAS scores specified participant's nocturnal pain in response to the following question Did you have any pain in the neck, back or hips during the previous night? 0=no pain to 100=worst pain possible. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1462312|NCT00762463|Secondary|Percentages of Participants Responding to Assessment in Ankylosing Spondylitis (ASAS)-20|Percentages of participants who demonstrated an improvement of greater than or equal to (≥) 20% from baseline and an absolute improvement of ≥10 mm from baseline on a 100-mm VAS in ≥3 of the 4 domains proposed by the Ankylosing Spondylitis Assessment Working Group (ASAS-20).|Weeks 2, 4, 6, 12|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||percentage of participants|||Number
1462313|NCT00762463|Secondary|Change From Baseline in BASDAI at Week 12|BASDAI is comprised of 6 specific questions, each answered on a 10-mm VAS. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1462314|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, and 6|Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was comprised of 6 specific questions, each answered on a 10-mm VAS scale. Scores for the first 5 questions: 0=none to 10=severe. Score for the sixth question: 0=0 hours to 10=2 hours. BASDAI score was defined as the mean of the scaled responses to these 6 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1462315|NCT00762463|Secondary|Change From Baseline in BASFI at Week 12|BASFI was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Lower scores indicated better functional health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1462316|NCT00762463|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, and 6|Bath Ankylosing Spondylitis Functional Index (BASFI) was comprised of 10 specific questions, each answered on a 10-mm VAS scale. 0=easy to 10=impossible. BASFI score was defined as the mean of the scaled responses to these 10 questions. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1462317|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|5-point Likert scale scores specified physician's subjective assessment on how the overall ankylosing spondylitis appeared at the time of the participant's visit and participant's disease signs. 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement.|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||units on a scale||Standard Deviation|Mean
1462318|NCT00762463|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, and 6|5-point Likert scale scores specified physician's subjective assessment on how overall ankylosing spondylitis appeared at the time of participant's visit and participant's disease signs. 1=very good to 5=very poor. Change from baseline <0 indicated improvement.|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||units on a scale||Standard Error|Least Squares Mean
1462319|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Week 12|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Lower scores indicated better health. Change from baseline <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||units on a scale||Standard Deviation|Mean
1462320|NCT00762463|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity at Weeks 2, 4, and 6|"5-point Likert scale scores specified participant's current situation in response to the following question Considering all the ways your Ankylosing Spondylitis affects you, how are you doing today? 1=very good to 5=very poor. Change from baseline <0 indicated improvement."|Baseline, Weeks 2, 4, 6|FAS. N = total evaluable participants. n = evaluable participants at that time point.|||units on a scale||Standard Error|Least Squares Mean
1462321|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 12|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain. Change from baseline of <0 indicated improvement."|Baseline, Week 12|FAS. n = evaluable participants at that time point.|||mm||Standard Deviation|Mean
1462322|NCT00762463|Secondary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Weeks 2 and 4|"100-mm VAS score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of <0 indicated improvement."|Baseline, Weeks 2, 4|Full Analysis Set (FAS). Number of participants analyzed (N) = total evaluable participants. n = evaluable participants at that time point.|||mm||Standard Error|Least Squares Mean
1462323|NCT00762463|Primary|Participant's Assessment of Global Pain Intensity at Baseline|"100-mm VAS scores specified participant's assessment of global pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Lower scores indicated less pain."|Baseline|PP|||mm||Standard Deviation|Mean
1462324|NCT00762463|Primary|Change From Baseline in Participant's Assessment of Global Pain Intensity at Week 6|"100-millimeter (mm) Visual Analog Scale (VAS) score specified participant's assessment of overall pain intensity in the previous 48 hours, in response to the following question What has been your global pain intensity in the last 48 hours? 0=no pain to 100=worst pain. Change from baseline of less than (<) 0 indicated improvement."|Baseline, Week 6|Per-Protocol (PP): All randomized participants who received at least one dose of study medication, and had global pain intensity assessment at Week 6 and no major protocol deviations.|||mm||Standard Error|Least Squares Mean
1462325|NCT00762450|Primary|ph of Dental Plaque After Sucrose Challenge|Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.|1 week||||ph of dental plaque||Standard Deviation|Mean
1462326|NCT00762424|Primary|Time of Stone Passage|Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known.|10 Days||||hours||Inter-Quartile Range|Median
1462327|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 16 Weeks After Cessation of Study Drug|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1462328|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 16 Weeks After Cessation of Study Drug|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1462329|NCT00762411|Secondary|Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks|Concentration of an amino acid peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1462330|NCT00762411|Secondary|Change From Baseline in Phosphorylated-Tau (P-tau) Concentration in Spinal Fluid up to 76 Weeks|Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1462331|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale (ADAS-Cog14) at 76 Weeks|ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1462332|NCT00762411|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) at 76 Weeks|ADAS-Cog12 is ADAS‑Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1462333|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) 4 Weeks After Cessation of Study Drug|Used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges: 0 to 30. Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1462342|NCT00762411|Secondary|Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks|A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer’s participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||ratio||Standard Error|Least Squares Mean
1504189|NCT00440830|Secondary|Sedation|Observer's Assessment of Alertness/Sedation Scale was used to report sedation.|1 hour after surgery|||||||
1462334|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 4 Weeks After Cessation of Study Drug|Assess QoL for AD; participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL. Participant's primary caregiver asked to complete same measure. Least Squares Mean value controlled for baseline, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but QoL-AD not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1462335|NCT00762411|Secondary|Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 4 Weeks After Cessation of Study Drug|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges: 0 to 100. Lower scores=greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1462336|NCT00762411|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) at 4 Weeks After Cessation of Study Drug|Assesses healthcare resource utilization (formal and informal care). Information gathered on both care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1462337|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 4 Weeks After Cessation of Study Drug|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. The Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1462338|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 4 Weeks After Cessation of Study Drug|Semi-structured interview. Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains; total score (SB) ranges: 0 to 18. Higher scores=greater disease severity. Least Squares Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.|Baseline (randomization), 4 weeks following treatment cessation|August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.||||||
1462339|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139|Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which drug distributes in the body.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
1462340|NCT00762411|Secondary|LY450139 Population Pharmacokinetics: Clearance of LY450139|Model estimated apparent oral clearance. Clearance is defined as the volume of plasma which is completely cleared of drug (LY450139) per unit time.|6 weeks, 12 weeks, and 52 weeks|All participants randomized to LY450139 with sufficient dosing information and concentration data to allow estimation of pharmacokinetic parameters.|||liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
1462341|NCT00762411|Secondary|Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks|Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1462367|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1504190|NCT00440830|Secondary|Nausea Assessment by Patient|Nausea scale range: 0=none and 10=the worst, ordinal.|1 hour after surgery|||||||
1462343|NCT00762411|Secondary|Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks|The vMRI assessment of right and left hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
1462344|NCT00762411|Secondary|Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks|Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||ratio||Standard Error|Least Squares Mean
1462345|NCT00762411|Secondary|Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks|Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.|Baseline (randomization), 52 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
1462346|NCT00762411|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) at 76 Weeks|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1462347|NCT00762411|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) at 76 Weeks|Assess QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant’s primary caregiver asked to complete same measure. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1462348|NCT00762411|Secondary|Change From Baseline in the EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) at 76 Weeks|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1462349|NCT00762411|Secondary|Change From Baseline in the Resource Utilization in Dementia-Lite (RUD-Lite) up to 76 Weeks|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.|Baseline (randomization), up to 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication, last observation carried forward (LOCF).|||number of hospitalizations||Standard Error|Least Squares Mean
1462350|NCT00762411|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) at 76 Weeks|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant’s behavior. Total score ranges from 12 to 144; higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1462351|NCT00762411|Secondary|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) at 76 Weeks|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1462352|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 16 Weeks After Cessation of Study Drug|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1466370|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 1|Subject Satisfaction - overall function|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1462353|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at 76 Weeks|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant’s caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1462354|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 16 Weeks After Cessation of Study Drug|The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 16 weeks following treatment cessation|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication and had both baseline and post-baseline evaluable data.|||units on a scale||Standard Error|Least Squares Mean
1462355|NCT00762411|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog11) at 76 Weeks|The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer’s disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.|Baseline (randomization), 76 weeks|Intent to treat (ITT) population: All randomized participants who received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
1462356|NCT00762385|Primary|Comfort Symptoms|A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable|1-week, 2-weeks|Only participants who completed the study per protocol (n=78)|||score||Standard Error|Least Squares Mean
1462357|NCT00762385|Secondary|Overall Corneal Staining|Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.|2 weeks|Only the participants who completed the study per protocol (n=78)|||combined score||Standard Error|Least Squares Mean
1462358|NCT00762385|Primary|Lens Comfort|>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.|1-week, 2- weeks|Only participants who completed the study per protocol (n=78)|||combined score||Standard Error|Least Squares Mean
1462359|NCT00762359|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.|18 Months||||participants|||Number
1462360|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462361|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462362|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462363|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462364|NCT00762359|Secondary|Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)|Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462365|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462366|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462450|NCT00762086|Primary|Absolute Claudication Distance (ACD)|Absolute walking distance is measured by walking on a treadmill until the point when the subject is inable to walk anymore due to pain in the leg. The walking distance is measured by meters|3 months|ITT cohort|||Meters||Standard Error|Least Squares Mean
1462368|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462369|NCT00762359|Secondary|Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)|Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462370|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462371|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462372|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462373|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462374|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)|Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462375|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462376|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462377|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462378|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462379|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)|Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462380|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462381|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462382|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462383|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462384|NCT00762359|Secondary|Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)|Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462385|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462386|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462387|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462388|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462389|NCT00762359|Secondary|Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)|Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462390|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462391|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462392|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462393|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462394|NCT00762359|Secondary|Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)|Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462395|NCT00762359|Secondary|Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)|Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Values are from the Full Analysis Set.|||participants|||Number
1462396|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462397|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462398|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462399|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462400|NCT00762359|Secondary|Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462401|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 18.|No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462402|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 12.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462403|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 9.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462404|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 6.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Median
1462405|NCT00762359|Secondary|Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)|The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.|Baseline and Month 3.|Values are from the Full Analysis Set.|||scores on a scale||Standard Deviation|Mean
1462406|NCT00762359|Primary|Number of Participants With Gastric Ulcer and/or Duodenal Ulcer|The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.|18 Months|Participants not taking investigational drug were not included.|||participants|||Number
1462407|NCT00762320|Secondary|Parent Satisfaction|Parent Satisfaction Survey. Eight item Likert scale of parent/guardian satisfaction with the child's HIV treatment regimen. Item scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 4 week, 12 weeks and 24 weeks||||Score on a survey||Standard Deviation|Mean
1462408|NCT00762320|Primary|Lopinavir and Ritonavir AUC on Low Dose Tablet|Lopinavir and Ritonavir AUC at 4 weeks when participants are receiving the study intervention, low dose tablet formulation of Kaletra. Data collection points for AUC were 0, 2, 4, 6, and 8 hours post dose.|4 weeks|All participants were analyzed|||hr*ng/ml||Standard Deviation|Median
1462409|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Cmax at 4 Weeks|Lpv and rtv Cmax at 4 weeks when participants are receiving study intervention, low dose Kaletra. Time points for data collection: 0, 2hrs, 4hrs, 6hrs, 8hrs|4 weeks|All participants were analyzed|||ng/ml||Standard Deviation|Median
1462410|NCT00762320|Primary|Viral Load (VL)|Number of participants who maintained their Viral load undetectable (< 20 copies/ml) for the duration of the study|Baseline, Week 4, Week 12 and Week 24|All subjects in study were analyzed|||participants|||Number
1462411|NCT00762320|Secondary|Symptoms Across All Patients|Cumulative tally of symptoms for each patients across all visits. Targetted symptoms were asked for at each visit and patients and parents were encouraged to report additional symptoms that were experienced. Each patient got a score for the total number of symptoms at each visit. Scores were totalled, but it the same symptoms occurred continuously it was counted as 1 symptom.|Baseline, 1 month, 3 months, 6 months|All participants analyzed|||numer of symptoms||Standard Deviation|Mean
1462412|NCT00762320|Secondary|Patient Satisfaction|Patient Satisfaction Survey. Eight item Likert scale of patient satisfaction with their HIV treatment regimen for patients 7 years of age and older. Items scores are summed to compute a total score. Total scores are reported with a minimum of 0 and a maximum of 32, with higher scores indicating higher satisfaction.|Baseline, 1 month|Patients had to be able to read and write to complete the patient satisfaction questionnaire, so an arbitrary age of 7 was selected and patients under the age of 7 did not complete the patient satisfaction questionnaire. All 5 of the patients over the age of 5 completed the questionnaire and were analyzed.|||units on a scale||Standard Deviation|Mean
1462413|NCT00762320|Primary|Lopinavir AUC Ratio of Baseline:Week 4|Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet). AUC data were collected at 0, 2, 4, 6, and 8 hours post dose.|Baseline, week 4||||ratio||Standard Deviation|Mean
1462503|NCT00761865|Secondary|Patient Satisfaction (Measured on a Visual Analog Scale)|Satisfaction on 0-10 scale with 10 being the best.|2 weeks post-sprain||||units on a scale||Full Range|Mean
1462414|NCT00762320|Primary|Lopinavir and Ritonavir Area Under the Curve (AUC) Liquid Kaletra|Area under the curve values for lopinavir at baseline when participants are taking liquid Kaletra as part of their baseline treatment. Time points for data collection: 0, 2 hrs post, 4 hrs post, 6 hrs post, 8 hrs post.|Baseline|All participants were analyzed|||hr*ng/ml||Standard Deviation|Median
1462415|NCT00762320|Primary|Lopinavir (Lpv) and Ritonavir (Rtv) Maximumu Plasma Concentration (CMax) Liquid|Cmax values at baseline (participants are taking liquid Kaletra as part of baseline treatment). Time points for data collection: 0, 2hrs post dose, 4 hrs post dose, 8 hrs post dose.|Baseline|All participants were analyzed|||ng/ml||Standard Deviation|Median
1462416|NCT00762320|Primary|Absolute CD4 and CD4 %|Number of participants who had no clinically significant deterioration in absolute CD4 and % CD4 count for the duration of the study. Absolute CD4 and Percent CD4 counts were determined by single or dual platform analysis performed on blood samples by Phoenix Children's Hospital Laboratory, Sonora Quest Laboratory or Labcorp Laboratory. Clinically significant change was determine to be a deterioration in both Absolute CD4 to less than 500 and %CD4 to less than 25%.|Baseline, 4 weeks, 12 weeks, 26 weeks|All participants were analyzed.|||participants|||Number
1462417|NCT00762268|Secondary|YMRS||6-weeks|||||||
1462418|NCT00762268|Secondary|HAM-D||6-weeks|||||||
1462419|NCT00762268|Primary|MADRS|Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and lower intensity.|At each weekly visit for 4 weeks||||units on a scale||Full Range|Mean
1462420|NCT00762229|Secondary|Total Cholesterol|Total cholesterol fasting|4 weeks||||mg/dL||Standard Deviation|Mean
1462421|NCT00762229|Primary|LDL Cholesterol|LDL cholesterol|4 weeks||||mg/dL||Standard Deviation|Mean
1462422|NCT00762216|Secondary|Residual Refractive Cylinder|The refractive astigmatism 6 months post-surgery, measured in diopters.|6 Months post-surgery|69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.|||diopters||Standard Error|Mean
1462423|NCT00762216|Primary|Rotational Stability|Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.|6 Months post-surgery|67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.|||degrees||Standard Error|Mean
1462424|NCT00762177|Primary|Antimicrobial Species on the Cheek(Veillonella)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462425|NCT00762177|Primary|Antimicrobial Species in Tongue(Veillonella)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462426|NCT00762177|Primary|Antimicrobial Species in Saliva(Veillonella)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462427|NCT00762177|Primary|Antimicrobial Species in Plaque(Veillonella)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462428|NCT00762177|Primary|Antimicrobial Species on the Cheek(Sulfur Bacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462429|NCT00762177|Primary|Antimicrobial Species in Tongue(Sulfur Bacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462430|NCT00762177|Primary|Antimicrobial Species in Saliva(Sulfur Bacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462431|NCT00762177|Primary|Antimicrobial Species in Plaque(Sulfur Bacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462432|NCT00762177|Primary|Antimicrobial Species on the Cheek(Oral Streptococci)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462433|NCT00762177|Primary|Antimicrobial Species in Tongue(Oral Streptococci)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462434|NCT00762177|Primary|Antimicrobial Species in Saliva(Oral Streptococci)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462435|NCT00762177|Primary|Antimicrobial Species in Plaque(Oral Streptococci)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462436|NCT00762177|Primary|Antimicrobial Species on the Cheek(Fusobacteria)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462437|NCT00762177|Primary|Antimicrobial Species in Tongue(Fusobacteria)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462438|NCT00762177|Primary|Antimicrobial Species in Saliva(Fusobacteria)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462439|NCT00762177|Primary|Antimicrobial Species in Plaque(Fusobacteria)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462440|NCT00762177|Primary|Antimicrobial Species on the Cheek(Total Anaerobic)|After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462441|NCT00762177|Primary|Antimicrobial Species in Tongue(Total Anaerobic)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462442|NCT00762177|Primary|Antimicrobial Species in Saliva(Total Anaerobic)|After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462443|NCT00762177|Primary|Antimicrobial Species in Plaque(Total Anaerobic)|After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462444|NCT00762177|Primary|Antimicrobial Species on the Cheek(Actinomyces)|After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462445|NCT00762177|Primary|Antimicrobial Species on the Tongue(Actinomycetes)|After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462446|NCT00762177|Primary|Antimicrobial Species in Saliva(Actinomyces)|Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462447|NCT00762177|Primary|Antimicrobial Species in Plaque(Actinomyces)|After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|14 days||||log CFU (Colony forming units)||Standard Error|Log Mean
1462448|NCT00762164|Secondary|Total Cholesterol||6 weeks||||% change in total cholesterol||Standard Deviation|Mean
1462449|NCT00762164|Primary|LDL Cholesterol||6 weeks||||% change in LDL cholesterol||Standard Deviation|Mean
1462451|NCT00762073|Secondary|Mean Change in Blood Pressure (BP) at End of Treatment|BP was assessed for each treatment group at baseline and at each post-baseline visit including the final treatment evaluation.|Baseline, 12 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.|||mmHg||Standard Deviation|Mean
1462452|NCT00762073|Secondary|Percent of Participants With Potential Corticosteroid-Related Treatment-Emergent Adverse Events (TEAEs)|Corticosteroid-Related TEAEs included candidiasis, oesophageal candidiasis, crying, psychomotor hyperactivity, aggression, anger, anxiety, conduct disorder, emotional disorder, insomnia, or mood altered mood. Corticosteroid-Related TEAEs were assessed systematically during the treatment and taper periods.|15 weeks after the start of treatment|The Safety Analysis Set, defined as all randomized participants who received at least one dose of double-blind study drug.|||percentage of participants|||Number
1462453|NCT00762073|Secondary|Area Under The Plasma Concentration-Time Curve (AUC) of Budesonide From Time Zero to Time of The Last Measurable Concentration (AUC0-last)|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||hr*pg/mL||Standard Deviation|Mean
1462454|NCT00762073|Secondary|Time to Maximum (Tmax) And Half Maximum (T1/2) Plasma Concentration of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together. T1/2 is the time to terminal elimination half-life.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The PK Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||hours||Standard Deviation|Mean
1462455|NCT00762073|Secondary|Maximum Plasma Concentration (Cmax) of Budesonide|On the day that pharmacokinetic (PK) blood samples were obtained, each participant delayed the morning dose of study medication until instructed to dose in the clinic. The sampling timepoints included pre-dose (0), and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose. The lower limit of quantitation (LLOQ) for the analytical method was approximately 20 pg/mL in plasma using 0.2 mL of the sample. Because the PK analyses for the medium and high dose oral budesonide suspension (OBS) groups were based on plasma samples collected following administration of identical single doses of OBS, the data for the medium-dose group (OBS once-daily) and high-dose group (OBS twice-daily) were summarized together.|Week 2, 4, or 8, or at the Final Treatment Evaluation|The Pharmacokinetic (PK) Set, defined as all participants in the safety analysis set who received oral budesonide suspension (OBS) and had sufficient PK samples to calculate PK parameters.|||pg/mL||Standard Deviation|Mean
1462456|NCT00762073|Secondary|Change From Baseline in Physician's Global Assessment Score of Disease Severity|"Physician investigators were asked to complete a visual analog scale (VAS) to provide a global assessment of eosinophilic esophagitis (EoE) activity in each participant. The VAS was a 100-mm horizontal line on which the right extreme (100) was labeled “worst possible disease activity” and the left (0) was labeled “no disease activity.” Investigators were instructed to consider the line for the VAS as a continuum with their own opinion of extremes on either end. Investigators drew a vertical line at a point that best approximated the participant's current level of EoE disease activity. The investigator was to take into consideration how esophageal disease was impacting the participant’s daily activities. The following instruction was given to the investigators: Using the visual analog scale below, please mark a vertical line on the scale to indicate your assessment of EoE activity in this participant at this time. A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||scores on a scale||Standard Deviation|Mean
1462457|NCT00762073|Secondary|Percent Change From Baseline in Eosinophilic Esophagitis (EoE) Clinical Symptom Score (CSS)|"The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1= Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2= Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3= Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors.~A negative change from baseline indicates that symptoms decreased."|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percent change||Standard Deviation|Mean
1462504|NCT00761865|Primary|Modified Karlsson Score|Ankle function score - range 0 to 100. Higher score is better ankle function.|2 weeks post-sprain||||units on a scale||Full Range|Mean
1462505|NCT00761813|Secondary|Complications, Including Avascular Necrosis, Nonunion, and Infection||Measured 2 years after original surgery||||participants|||Number
1462506|NCT00761813|Secondary|Quality of Life|The SF-12 PCS is the short form - 12 Health Survey Physical component summary - 0 is bad and 100 is good The WOMAC is Western Ontario and McMaster Universities Osteoarthritis Index 0 is good and 100 is bad The EQ-5D is EuroQol5D 1 is good and 5 is bad|Measured 2 years after original surgery|secondary outcomes not given or completed to all subjects|||units on a scale||Standard Deviation|Mean
1462458|NCT00762073|Secondary|Percent of Participants With Clinical Remission|"Clinical remission was defined as an eosinophilic esophagitis (EoE) clinical symptom score (CSS) of zero. EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1462459|NCT00762073|Secondary|Percent of Participants With Clinical Response|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS). The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1462460|NCT00762073|Secondary|Change From Baseline in Endoscopy Score|Esophageal endoscopy was used to assess the level of inflammation and eosinophilia. Four categories of endoscopic findings were evaluated and scored for this study: (1) pallor and diminished vascular markings; (2) furrowing with thickened mucosa; (3) presence of white mucosal plaques; and (4) concentric rings or strictures. For each category, 0 points were allocated if no esophageal sites were involved, 1 point if 1 or 2 esophageal sites were involved, and 2 points for pan-esophageal involvement (see Aceves et al., 2007). The maximum possible endoscopy score was 8 points. A negative change from baseline indicates that esophageal inflammation decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||scores on a scale||Standard Deviation|Mean
1462461|NCT00762073|Secondary|Percent Change From Baseline in Peak Eosinophil Count|The maximum peak number of eosinophils at baseline and at the final treatment evaluation was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value. A negative change from baseline indicates that eosinophil count has decreased.|Baseline, 12 weeks after the start of treatment|The FAS, defined as all participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percent change||Standard Deviation|Mean
1462462|NCT00762073|Secondary|Percent of Participants With Histologic Remission|Histologic remission was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤1 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1462463|NCT00762073|Secondary|Percent of Participants With Histologic Response|Histologic response was defined as a maximum peak eosinophil count at the final treatment evaluation of ≤6 eosinophils/high power field (light microscopy). The maximum peak was identified by examining the peak eosinophil counts obtained from the proximal, mid, and distal esophageal biopsies and selecting the maximum value.|12 weeks after the start of treatment|The FAS, defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1462464|NCT00762073|Primary|Percent of Participants Who Responded to Therapy|"Response was defined as a ≥50% reduction from baseline in the eosinophilic esophagitis (EoE) clinical symptom score (CSS) and a reduction in peak eosinophil count to ≤6/high power field (light microscopy) from esophageal biopsies collected at the final evaluation. The EoE CSS, scored from 0 to 18 by a doctor, assessed 6 categories: 1) heartburn, 2) abdominal pain, 3) nocturnal awakening with symptoms, 4) nausea, regurgitation, or vomiting, 5) anorexia or early satiety, and 6) dysphagia, odynophagia, or food impaction (a severe symptom). Each domain was scored as follows, based on symptoms in the 2 weeks prior to the assessment:~0 = No symptoms and no coping behaviors required; 1 = Mild: Symptoms limited to 1-3 days or no symptoms because coping behaviors were required to avoid symptoms; 2 = Moderate: Symptoms on >3 days, with or without minor coping behaviors; 3 = Severe: Symptoms interfered with activities of daily living or symptoms persisted and required major coping behaviors."|12 weeks after the start of treatment|The Full Analysis Set (FAS), defined as participants who received at least one dose of study drug and had evaluable post-baseline esophageal biopsy and clinical symptom data.|||percentage of participants|||Number
1462465|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Membrane Folate Receptor Alpha (FR-α) Expression|Cytoplasmic and membrane Folate Receptor Alpha (FR-α) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic or membrane staining, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). FR-α Positive have an H score >0 and FR-α Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with FR-α Cytoplasm or Membrane H scores. Participants censored: FR-α Positive Cytoplasm n=21, 15 and Negative n=4, 3; FR-α Membrane Positive n=16, 8 and Negative n=9, 10 for Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1462466|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Cytoplasmic and Nuclear Thymidylate Synthase (TS) Expression|Cytoplasmic and nuclear Thymidylate Synthase (TS) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H score was calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TS Positive have an H score >0 and TS Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TS Cytoplasm and Nucleus H scores. Participants censored: TS Cytoplasm Positive n=23, 20 and Negative n=4, 1; TS Nucleus Positive n=17, 9 and Negative n=10, 12 for the Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1462467|NCT00762034|Secondary|Translational Research: Overall Survival (OS) Based on Nuclear Thyroid Transcription Factor-1 (TTF-1) Expression Regardless of Study Treatment|Nuclear Thyroid Transcription Factor-1 (TTF-1) expression was measured using an Immunohistochemistry (IHC) assay which were scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system, and H score is a calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+). TTF-1 Positive have an H score >0 and TTF-1 Negative have an H score=0. Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants with TTF-1 H scores regardless of study treatment. Participants censored: n=38, 11 in the TTF-1 Nuclear Positive and Negative arms, respectively.|||months||95% Confidence Interval|Median
1462468|NCT00762034|Secondary|Translational Research: Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations|Epidermal Growth Factor Receptor (EGFR) mutations were measured by polymerase chain reaction (PCR).|Baseline|All randomized participants with EGFR data regardless of study treatment.|||participants|||Number
1462469|NCT00762034|Secondary|Pharmacokinetics (PK): Bevacizumab Clearance (CL)||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.|||liters per day (L/day)||Geometric Coefficient of Variation|Geometric Mean
1462470|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.|||microgram*day per milliliter (μg•day/mL)||Geometric Coefficient of Variation|Geometric Mean
1462471|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.|||days||Geometric Coefficient of Variation|Geometric Mean
1462472|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Bevacizumab||Cycle 1 (pre-dose, 0.75, 1.5, 3, 5, 7, 24, 48, 72, 168, 336, and 503 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1462473|NCT00762034|Secondary|Pharmacokinetics (PK): Platinum Clearance (CL) for Total (Bound and Unbound) and Unbound Forms|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable CL data.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1462474|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable AUC(0-∞) data.|||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1462475|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable t1/2 data.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
1462476|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Total (Bound and Unbound) Platinum and Unbound Platinum|Platinum is a metabolite of Carboplatin (Carbo) and is found in the blood as both a bound and unbound form.|Cycle 1 (pre-dose, 0.25, 0.5, 0.67, 1.42, 2.17, 4, 6, 8, 24, 48, and 72 hours post-dose)|Randomized participants who received study drug and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1462477|NCT00762034|Secondary|Pharmacokinetics (PK): Pemetrexed Clearance (CL)||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable CL data.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
1462478|NCT00762034|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC(0-∞)) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable AUC(0-∞) data.|||microgram*hour per milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1462479|NCT00762034|Secondary|Pharmacokinetics (PK): Elimination Half-life (t1/2) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable t1/2 data.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
1462480|NCT00762034|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) for Pemetrexed||Cycle 1 (pre-dose, 0.17, 0.33, 0.58, 0.83, 1, 1.75, 2.5, 4. 6. 8, and 24 hours post-dose)|Participants who were randomized to Pem/Carbo/Bev, who received study drug, and had evaluable Cmax data.|||micrograms per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
1462481|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity (FACT/GOG-Ntx)|FACT/GOG-Ntx is a validated instrument used to measure quality of life (QOL) in participants with cancer and neurotoxicity (Ntx) consisting of 27-item FACT-General (G) and 11-item Ntx subscale. FACT-G is organized into domain subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items; each uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT/GOG-Ntx Total Score=sum 5 subscales and ranges from 0-152. Ntx Trial Outcome Index (TOI-Ntx)=PWB+FWB+NTX and range from 0-100. For all FACT scales, higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT/GOG-Ntx data, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
1462482|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Lung (FACT-L)|FACT-L is a valid instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)–7 items; social/family well-being (SWB)–7 items; emotional well-being (EWB)–6 items; functional well-being (FWB)–7 items. Each item uses a 5 point rating scale (0=“not at all” and 4=equals “very much”). FACT-L Total Score=4 subscales + LCS and ranges from 0 to 144. Trial Outcome Index-Lung (TOI-L)=PWB+FWB+LCS and ranges from 0 to 92. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction.|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-L, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
1462483|NCT00762034|Secondary|Change From Baseline in Participant Reported Outcomes as Assessed by the Functional Assessment of Cancer Therapy - General (FACT-G)|"The FACT-G is a validated instrument used to measure quality of life (QOL) in participants with cancer consisting of the 27-item questionnaire and is organized into subscales, each designed to assess a QOL domain: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-G Total is the sum of the scores of all 4 subscales and ranges from 0 to 108. Higher scores indicate better QOL. Least squares mean (LSmean) change is calculated using the linear-mixed model (LMM) analysis controlled for treatment, baseline value, time point and treatment by time point interaction."|Baseline, up to first 10 cycles (4 induction and 6 maintenance cycles, cycle=21 days)|The LMM analysis includes data from all participants in each arm for whom a validated translation is available in a language in which the completer (participant) is fluent and have evaluable FACT-G data, using the intent-to-treat principle.|||units on a scale||Standard Error|Least Squares Mean
1462484|NCT00762034|Secondary|Number of Participants Receiving Concomitant Medication||Baseline to study endpoint (up to 37.06 months)|All randomized participants|||participants|||Number
1462485|NCT00762034|Secondary|Number of Participants Who Received a Transfusion||Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1462486|NCT00762034|Secondary|Duration of Hospitalizations Per Participant|Length of hospitalization in participants hospitalized during the study or within 30 days of discontinuation regardless of whether the hospitalization was or was not due to study drug.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug and had at least one hospitalization while on study or within 30 days of discontinuation.|||days||Standard Deviation|Mean
1462487|NCT00762034|Secondary|Safety and Toxicity Profile of Study Treatments|Safety and toxicity profile was defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module.|Baseline to study endpoint (up to 37.06 months)|All randomized participants who received at least 1 dose of study drug during the specified treatment phase.|||participants|||Number
1462488|NCT00762034|Secondary|Time to Progressive Disease|Time to progressive disease was defined as the time from randomization to the first date of objective disease progression. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=198, 172 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1462489|NCT00762034|Secondary|Progression Free Survival Time|Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.|Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=127, 109 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1462507|NCT00761813|Primary|Revision Surgery|Additional Surgery on the affected hip|Measured 2 years after original surgery||||Participants|||Count of Participants
1462508|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
1462490|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)|Disease Control Rate (DCR) is the number of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared with baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions compared with the smallest sum of the longest diameter recorded since the start of treatment or the appearance of 1 or more new lesion(s). Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle|||percentage of participants||95% Confidence Interval|Number
1462491|NCT00762034|Secondary|Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)|Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.|Baseline to measured progressive disease (up to 37.06 months)|All randomized participants using the intent-to-treat principle|||percentage of participants||95% Confidence Interval|Number
1462492|NCT00762034|Primary|Overall Survival|Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.|Baseline to date of death from any cause (up to 37.06 months)|All randomized participants using the intent-to-treat principle. Number of participants censored: n=131, 127 in Pem/Carbo/Bev and Pac/Carbo/Bev arms, respectively.|||months||95% Confidence Interval|Median
1462493|NCT00762021|Primary|9% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.|||LogMAR||Standard Deviation|Mean
1462494|NCT00762021|Primary|100% LogMAR Best Corrected Visual Acuity (BCVA)|"Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background.~VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity."|24 months after surgery|Data for all patients completing the 24 month visit were analyzed.|||LogMAR||Standard Deviation|Mean
1462495|NCT00762021|Primary|Posterior Capsule Opacification (PCO)|Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area.|2 years after surgery|Data for all patients completing the 24 month visit were analyzed.|||Percentage of PCO||Standard Deviation|Mean
1462496|NCT00761969|Secondary|Incidence of Revascularization Procedures|Incidence of coronary, carotid and peripheral arterial revascularization procedures|5 years||||participants|||Number
1462497|NCT00761969|Primary|Incidence of Major Cardiovascular Events|Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.|5 years:||||participants|||Number
1462498|NCT00761956|Secondary|Return to Function (RtF) Via Knee Scoiety Score (Modified)|"Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals.~Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor."|24 Months|There was one case in the CR Flex Fixed cohort and 3 in the CR Standard Knee cohort where the Return to Function was not complete. Therefore, the total number analyzed is 51 instead of 52 and 45 instead of 48 respectfully.|||units on a scale||Standard Deviation|Mean
1462499|NCT00761956|Primary|Postoperative Range of Motion (ROM)|The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.|24 Months|There was one case in the CR Standard Knee cohort where the Range of Motion was not complete. Therefore, the total number analyzed is 47 and not 48.|||degrees||Standard Deviation|Mean
1462500|NCT00761930|Primary|Bleeding Index (EIBI)|Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.|6 weeks||||Units on a scale||Standard Deviation|Mean
1462501|NCT00761930|Primary|Gingivitis Score|"Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,~1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored."|6 weeks||||Units on a scale||Standard Deviation|Mean
1462502|NCT00761930|Primary|Dental Plaque|Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.|6 weeks||||Units on a scale||Standard Deviation|Mean
1462509|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
1462510|NCT00761774|Secondary|Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)|BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.|During the Evaluation Period (up to 9 years)|The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.|||percentage of participants|||Number
1462511|NCT00761774|Primary|Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1462512|NCT00761774|Primary|Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1462513|NCT00761774|Primary|Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)|Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.|During the Evaluation Period (up to 9 years)|The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.|||percentage of participants|||Number
1462514|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms|Symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HARS). Minimum score = 0, Maximum score = 60. Higher scores on HARS indicate worse functioning|Baseline and 8 week treatment|Stable Bipolar Patients|||units on a scale||Standard Deviation|Mean
1462515|NCT00761761|Secondary|Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.|Manic symptoms were measured using the Young Mania Rating Scale (YMRS). Minimum score = 0, Maximum score = 60. Higher scores on YMRS indicate worse functioning.|Baseline and 8 weeks treatment|Stable Bipolar Patients|||units on a scale||Standard Deviation|Mean
1462516|NCT00761761|Secondary|Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms|Depressive symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Minimum score = 0, Maximum score = 60. Higher scores on MADRS indicate worse functioning.|Baseline and 8 week treatment|Stable Bipolar patients|||units on a scale||Standard Deviation|Mean
1462517|NCT00761761|Primary|Change From Baseline in Digit-Span Score at 8 Weeks|"Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented.~The raw scores for digit span ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome."|8 week treatment||||units on a scale||Standard Error|Least Squares Mean
1462518|NCT00761748|Primary|Preference of the Two Urostomy Products|"Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product.~The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred."|6 weeks|The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). *One drop out was evaluable, as the subject tried both products and stated a preference.|||participants|||Number
1462519|NCT00761735|Primary|Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender|The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.|Last assessment of the Part 2 LTFU (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU with non-missing Tanner Stage data at the last observation (up to Year 5 of the LTFU) were analyzed.|||years||Standard Deviation|Mean
1462724|NCT00760266|Secondary|Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8|Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg|At Weeks 4 and 8|Full analysis set|||Percentage of Participants|||Number
1462520|NCT00761735|Primary|Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
1462521|NCT00761735|Primary|Mean Weight Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
1462522|NCT00761735|Primary|Mean Height Percentiles of Participants Over LTFU|To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.|Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)|All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.|||percentile||Standard Deviation|Mean
1462523|NCT00761735|Primary|Number of Participants Who Relapsed At End of LTFU Year 5|Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.|Part 2 LTFU Year 5|Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.|||participants|||Number
1462524|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2|Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days.|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1462525|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1|Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary.|From the day of dose 1 (Day 1) to Day 7 of dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1462526|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 2 (Day 1) to Day 7 of dose 2|Dose 2 Safety Population: all participants who received 2 doses of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1462527|NCT00761631|Other Pre-specified|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).|From the day of dose 1 (Day 1) to Day 7 after dose 1|Dose 1 Safety Population: all participants who received the first dose of 13vPnC. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||Percentage of participants|||Number
1462528|NCT00761631|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4|Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3 and 4|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with a determinate antibody titer.|||titer||95% Confidence Interval|Geometric Mean
1462529|NCT00761631|Primary|Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)|Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules.|28 to 42 days after dose 1|||||||
1462530|NCT00761631|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3|Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.|28 to 42 days after dose 1 for Group 3|EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.|||mcg/mL||95% Confidence Interval|Geometric Mean
1462531|NCT00761631|Primary|Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2|Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.|28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2|Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1462532|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1462533|NCT00761605|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics."|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462534|NCT00761605|Secondary|Change From Baseline in Krawiecka Scale Score at Week 24|Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462535|NCT00761605|Secondary|Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Millimeter (mm)||Standard Deviation|Mean
1462536|NCT00761605|Secondary|Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Millimeter (mm)||Standard Deviation|Mean
1462553|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462537|NCT00761605|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1462538|NCT00761605|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462539|NCT00761605|Primary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 24|"Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1462540|NCT00761592|Secondary|Duration of Action|Median Duration for decision to reinject|Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)|Intention to Treat|||Weeks||Standard Deviation|Median
1462541|NCT00761592|Secondary|Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score|"Subjective satisfaction rating: -4: marked worsening, -3: moderate worsening, -2: marked worsening in symptoms, -1: mild worsening in symptoms, 0: no effect~+1: mild improvement in symptoms, +2: moderate improvement in symptoms, +3: mild improvement, +4: marked improvement. A positive change from baseline indicated improvement."|Baseline to Week 4 and 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1462542|NCT00761592|Secondary|Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)|Jankovic Rating Scale Severity: 0 - None; 1 - Minimal; 2 - Mild; 3 - Moderate; 4 - Severe. Frequency: 0 - None; 1 - Slight increase; 2 - Fluttering duration less than 1 second; 3 - Spasm greater than 1 second and eyes open > 50% of waking time; 4 - Functionally blind. The range of the total score was from 0 (None) to 8 (Severe and Functionally Blind). A negative change from baseline indicated improvement.|Baseline to Week 4 and Week 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1462543|NCT00761592|Secondary|Change From Baseline to Week 8 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point (0-4) scale with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 8|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1462544|NCT00761592|Primary|Change From Baseline to Week 4 in Blepharospasm Disability Index|"Blepharospasm Disability Index is a validated 5-point scale (0-4) with six items (e.g., reading, driving a vehicle).~0 - no impairment, 1 - mild impairment, 2 - moderate impairment, 3 - severe impairment, 4 - not possible due to disease, N/A - Not applicable.~The total score ranged from 0 (no impairment) to 24 (not possible due to disease). A negative change from baseline indicated improvement."|Baseline to Week 4|Intention to Treat|||Points on Scale||Standard Deviation|Mean
1462545|NCT00761579|Secondary|Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48|The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1462636|NCT00760747|Secondary|Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||mmHg||Standard Deviation|Mean
1462546|NCT00761579|Secondary|Change From Baseline in Sleep Quality at Week 48|Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||millimeter (mm)||Standard Deviation|Mean
1462547|NCT00761579|Secondary|Change From Baseline in Daytime Drowsiness at Week 48|Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||millimeter (mm)||Standard Deviation|Mean
1462548|NCT00761579|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48|The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
1462549|NCT00761579|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1462550|NCT00761579|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462551|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462552|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462725|NCT00760266|Secondary|Percentage of Responders at Week 4 and Week 8|Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline|At 4 weeks and 8 weeks|Full analysis set|||Percentage of Participants|||Number
1496195|NCT00504556|Secondary|Effects on Biomarker Prothrombin Fragments|Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)|3 months||||pmol/L||Standard Deviation|Mean
1462554|NCT00761579|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.|Baseline and Week 48|Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
1462555|NCT00761527|Primary|Participant Global Tolerability Assessment|"The participant’s global assessment of tolerability with the medication was assessed using a categorical scale as follows:~Excellent~Very Good~Good~Fair~poor~Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented."|Day 15|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.|||Participants|||Number
1462556|NCT00761527|Secondary|Investigator Assessment of Clinical Efficacy|Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.|Day 15|ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported.|||Participants|||Number
1462557|NCT00761527|Primary|Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment|Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.|||Participants|||Number
1462558|NCT00761527|Primary|Number of Adverse Events Reported By Category After 14 Days of Treatment|Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.|15 Days|The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.|||Adverse Events|||Number
1462559|NCT00761514|Primary|Percent Change From Baseline to Week 24 in Average Score on Section 1 of the Modified Multi-Dimensional Health Assessment Questionnaire (mHAQ) That Includes Ratings of Sleep, Anxiety, Depression or Feeling Blue, and Ability to do Daily Activities.|Section 1 of the mHAQ includes subject ratings of difficulty in: dressing; getting out of bed; lifting a full glass to the mouth; walking outdoors on flat ground; bathing; bending to pick up clothes from floor; getting in/out of car, bus, train, plane; walking 2 miles; participating in sports and games; getting a good night's sleep; dealing with feelings of anxiety, being nervous; dealing with feelings of depression, feeling blue. Without any difficulty=0, With some difficulty=1, With much difficulty=2, Unable to do=3. Ratings are summed. The maximum total score is 39. Low total score is good.|Week 24 of treatment|Available subject data were used in calculations; 14 at Baseline and 7 at Week 24. Missing data were not imputed.|||Percent change in average total score|||Number
1462560|NCT00761514|Secondary|Percent Change From Baseline to Week 24 in Average Score on the Short Disease Activity Score|On visual analog scale (VAS), patient marks activity of rheumatoid arthritis in previous 24 hours (0 mm=no symptoms; 100 mm=very active). On another VAS, patient marks how much pain (0 mm=no pain; 100 mm=severe pain) he/she had because of the illness in previous week. Patient also marks tender joints and swollen joints on body diagrams. Number of swollen and painful joints and values on VAS are used with erythrocyte sedimentation rate to calculate the patient's global assessment of disease activity. High score indicates high activity.|Week 24 of treatment|Available subject data were used in calculations. Missing data were not imputed.|||Percent change in average score|||Number
1462561|NCT00761462|Primary|Incidence of Nervous System Events (Cumulative)|Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug).|||participants|||Number
1462562|NCT00761462|Primary|Incidence of Arthropathy (Cumulative)|Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.|4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment|Patients valid for safety (all patients confirmed to have received at least one dose of study drug)|||participants|||Number
1462563|NCT00761345|Secondary|To Measure Progression Free Survival and Overall Survival||Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survival|||||||
1462564|NCT00761345|Primary|To Determine the Dose Limiting Toxicities||weekly physician and nurse assessment and in between as needed until 30 days after treatment termination|27 patients (median age 64years and 15 male) with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible.|||participants|||Number
1462565|NCT00761319|Secondary|Percentage of Patients With Corneal Fluorescein Staining Score = 0|The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.|Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.|||Percentage of patients|||Number
1462566|NCT00761319|Primary|Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.|Day 0, Day 90|Intent to treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. Last-observation-carried-forward was used to impute values for dropouts and for missing data on a scheduled study visit during the masked treatment period.|||Units on a scale||Standard Error|Mean
1462567|NCT00761306|Secondary|Proportion of Remitters at Week 52 (Remission Defined as a MADRS Total Score <=10)||Week 52|FAS; OC|||percentage of patients|||Number
1462568|NCT00761306|Secondary|Proportion of Responders at Week 52 (Response Defined as a >=50% Decrease in MADRS Total Score)||Week 52|FAS; OC|||percentage of patients|||Number
1462569|NCT00761306|Secondary|Change From Baseline in HAM-D-24 Total Score After 52 Weeks of Treatment|The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.|Baseline and Week 52|FAS; OC|||units on a scale||Standard Deviation|Mean
1462570|NCT00761306|Secondary|Change From Baseline in MADRS Total Score After 52 Weeks of Treatment|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 52|FAS; observed cases (OC)|||units on a scale||Standard Deviation|Mean
1462571|NCT00761306|Primary|Percentage of Patients Who Withdrew Due to Intolerance to Treatment||Baseline to Week 52|APTS|||percentage of patients|||Number
1462572|NCT00761306|Primary|Number of Patients With Adverse Events (AEs)||Up to 52 weeks and a 4-week safety follow-up period|APTS|||participants|||Number
1462573|NCT00761280|Secondary|Median Time to Progression (Days) by Independent Review for the Intent-to-treat Population (Descriptive Analysis, Only)|Time to progression was calculated from the date of randomization to the date of the first documented tumor progression. Participants who did not progress or died were censored at the last tumor assessment date or the date of start of a new anti-tumor treatment or death.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||days||95% Confidence Interval|Median
1462574|NCT00761280|Secondary|Disease Progression Rate at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21 and 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
1462575|NCT00761280|Secondary|Disease Progression at 10, 12, 14, 16, 18, 21, and 24 Months by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Based on clinical and imaging data, an independent neuro-oncologist made the final assessment of Progressed versus Not Progressed. Participants who had MRI assessment results missing or unknown were UNK or missing, and were treated as Progressed for the purposes of the calculation."|10, 12, 14, 16, 18, 21, and 24 months|The Intent-to-treat population includes all participants randomized.|||participants|||Number
1462576|NCT00761280|Secondary|Median Duration of Response (Days) by Independent Review (Descriptive Analysis, Only)|"Duration of response was defined as the time from the first documentation of confirmed response (Complete Response, CR, or Partial Response, PR) to the first signs of Progressive Disease (PD), as assessed by the study neuro-oncologist. Median Duration of Response was calculated by Kaplan-Meier estimate.~Censoring rules were:~at the date of randomization -- participants without baseline assessments, or for those with no post-baseline timor assessments who were discontinued for other than progressive disease or death.~at the date of last tumor assessment -- discontinuation other than PD or death, or if a new treatment was started prior to disease progression~at the date of death or last tumor assessment -- death or PD after one missed tumor assessment~at the date of last tumor assessment -- death or PD after more than one missed tumor assessment~at the date of last tumor assessment -- participants on ongoing treatment at data cut-off"|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||days||95% Confidence Interval|Median
1462577|NCT00761280|Primary|Survival at 24 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at 24 months from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to / insufficient follow-up includes participants who were alive at last data collection point but did not yet have enough follow-up time to reach the 24 month time point."|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||participants|||Number
1462578|NCT00761280|Secondary|Tumor Control Rate (CR+PR+SD) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Tumor control rate was defined as the proportion of participants assessed as having Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Participants with unknown or missing response were treated as non-responders.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
1462579|NCT00761280|Secondary|Overall Response Rate (CR+PR) by Independent Review in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Overall response rate was the proportion of participants with a best response of Complete Response (CR) or Partial Response (PR) observed from the start of treatment until disease progression.|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||percentage of participants||95% Confidence Interval|Number
1462580|NCT00761280|Secondary|Response Category by Independent Review in the Intent-to-treat Population - Number of Participants|"Tumor response was classified based on the (neuro-)radiologist’s evaluation according to the Macdonald Response Criteria for bidimensionally measurable disease as outlined below:~Complete Response (CR): Disappearance of all enhancing tumor on consecutive MRI scans at least 1 month apart, off steroids, neurologically stable or improved.~Partial Response (PR): ≥50% reduction in size of enhancing tumor on consecutive MRI scans at least 1 month apart, steroids stable or reduced, neurologically stable or improved.~Progressive Disease (PD): ≥25% increase in size of enhancing tumor or any new tumor on MRI scans, steroids stable or increased, neurologically worse.~Stable Disease (SD): all other situations.~Two qualified neuro-radiologists reviewed scans at each MRI time point, with adjudication of discrepancies by a third reviewer. Their findings and clinical information were independently reviewed by a neuro-oncologist, who made the assessment of overall response."|Up to 24 months|The Intent-to-treat population includes all participants randomized.|||participants|||Number
1462581|NCT00761280|Secondary|Median Overall Survival (Days) From Randomization in the Intent-to-treat Population (Descriptive Analysis, Only)|Median overall survival was defined as the date of randomization to the date of death. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis. Analysis was by Kaplan-Meier estimation.|Up to 24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||days||95% Confidence Interval|Median
1462582|NCT00761280|Secondary|Survival at 12, 18, and 21 Months in the Intent-to-treat Population - Number of Participants|"Survival status was assessed at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead. The category Lost to follow-up for each time-point includes participants who were alive at the last data collection point but did not yet have enough follow-up time to reach the time point."|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||participants|||Number
1462583|NCT00761280|Secondary|Survival Rate at 12, 18, and 21 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at each time-point from randomization. Participants with unknown or missing status were considered treatment failures, i.e., assumed to be dead.|12, 18, and 21 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||percentage of participants||95% Confidence Interval|Number
1462584|NCT00761280|Primary|Survival Rate at 24 Months in the Intent-to-treat Population - Percentage of Participants (Descriptive Analysis, Only)|Survival rate was defined as the proportion of participants known to be alive at 24 months from randomization. If a participant's status was unknown and there was no follow-up information available, they were categorized as 'Died' for the purposes of the analysis.|24 months|The Intent-to-treat population includes all participants randomized. Early study discontinuation with site closures led to a high proportion of participants being censored or lost to follow-up in the initial analysis. Additional survival data were collected in a post-hoc fashion under a protocol amendment. These data are presented.|||percentage of participants||95% Confidence Interval|Number
1462585|NCT00761215|Secondary|Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set||21-28 days after last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.|||Percentage of participants||95% Confidence Interval|Number
1462586|NCT00761215|Secondary|Population PK||Multiple|||||||
1462587|NCT00761215|Secondary|To Evaluate the Safety Profile of Tedizolid Phosphate||Multiple|||||||
1462588|NCT00761215|Secondary|Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set|Persistent clinical cure was defined as continuing favorable response.|21 to 28 days after the last study drug|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection. Microbiological samples not available from all participants.|||Percentage of Participants|||Number
1462589|NCT00761215|Secondary|Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set|Satisfactory microbiological outcomes are eradication and presumed eradication|7-14 days after last dose of study drug|The microbiologically evaluable analysis set includes all participants who received study drug, had a diagnosis of complicated skin and skin structure infection, completed an assessment, had no confounding events or factors, and had a baseline Gram-positive bacterial pathogen.|||Percentage of participants||95% Confidence Interval|Number
1462590|NCT00761215|Secondary|Response Rate at End of Therapy|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|last day of study treatment|The clinical modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection|||Percentage of participants||95% Confidence Interval|Number
1462591|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7-14 days after last dose of study drug|The clinically modified intent to treat analysis set includes data from all participants who received study drug and had a diagnosis of complicated skin and skin structure infection.|||Percentage of participants||95% Confidence Interval|Number
1462592|NCT00761215|Primary|Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set|Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.|7 to 14 days after the last dose of study drug|The Clinically Evaluable analysis set includes data from all participants who had a diagnosis of cSSSI, received minimal study therapy, completed an assessment, and had no confounding events or factors.|||Percentage of participants||95% Confidence Interval|Number
1462593|NCT00761202|Secondary|Lipid Layer Pattern Assessment|Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.|Week 1, month 1|Intent to Treat Population|||Lipid Layer Mixing Pattern||Full Range|Median
1462594|NCT00761202|Secondary|Daily Eyedrop Usage|Average daily eyedrop use|Month 1|Intent to Treat Population|||drops/day||Standard Deviation|Mean
1462595|NCT00761202|Secondary|Ocular Comfort and Ocular Symptoms on Visual Analogue Scale|Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)|week 1, month 1|Intent to Treat Population|||Units on a scale||Standard Deviation|Mean
1462596|NCT00761202|Secondary|Conjunctival Hyperaemia|Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
1462597|NCT00761202|Secondary|Corneal Staining by Fluorescein|Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
1462598|NCT00761202|Primary|Conjunctival Staining by Lissamine Green|Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)|week 1, month 1|Intent to Treat Population|||Percentage of Participants|||Number
1462599|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Participants|||Number
1462600|NCT00761189|Secondary|Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Participants|||Number
1462601|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Units on a scale||Standard Deviation|Mean
1462602|NCT00761189|Secondary|Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 2, 4, 8 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Units on a scale||Standard Deviation|Mean
1462659|NCT00760617|Secondary|HI Antibody Seroconversion Factor (SCF) at Day 21|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||fold increase||95% Confidence Interval|Geometric Mean
1462603|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1462604|NCT00761189|Secondary|Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 4 and 12|"Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
1462605|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Percentage of Participants|||Number
1462606|NCT00761189|Secondary|Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population|Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Percentage of participants|||Number
1462607|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Units on a scale||Standard Deviation|Mean
1462608|NCT00761189|Secondary|Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 4 and 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Units on a scale||Standard Deviation|Mean
1462609|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.|||Percentage of participants|||Number
1462610|NCT00761189|Primary|Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant’s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.|||Percentage of participants|||Number
1462611|NCT00761176|Primary|The Incidence of Wounds Reaching Complete Closure||approximate one year|Analysis was not done as this study was early terminated due to all subjects not meeting inclusion/exclusion criteria.||||||
1462637|NCT00760747|Secondary|Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint|The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
1462612|NCT00761150|Secondary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the secondary outcome measure included all randomized participants who received at least 1 dose of study drug during the DB period (DB intent-to-treat), had a DB baseline assessment, and had at least 1 assessment during the DB period.|||scores on a scale||Standard Error|Least Squares Mean
1462613|NCT00761150|Primary|Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.|Double-blind baseline to 4 weeks|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat).|||scores on a scale||Standard Error|Least Squares Mean
1462614|NCT00761137|Secondary|Percentage Change in Saliva Volume|Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined.|Before and 75 minutes after treatment administration|Percentage saliva volume change was determined in the last seven (7) patients enrolled.|||percentage change of saliva volume||95% Confidence Interval|Median
1462615|NCT00761137|Primary|Sialorrhea Visual Analogue Scale (VAS)|Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.|Before and 120 min after treatment administration||||cm on VAS||Standard Deviation|Mean
1462616|NCT00761007|Secondary|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat (ITT) subgroup of patients with IBS-D (N=234)|||Participants|||Number
1462617|NCT00761007|Post-Hoc|Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS-Diarrhea (IBS-D) and Pain at Baseline - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-treat subgroup of patients with IBS-D and baseline pain score>1 (in a 5-point scale ranging from 0=no pain to 4=very severe) (N=189)|||Participants|||Number
1462618|NCT00761007|Secondary|Response of Overall IBS Symptom Relief - 75% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 3/4 weeks (75% rule)"|Four weeks|Intention-to-Treat (N=544)|||Participants|||Number
1462619|NCT00761007|Primary|Response of Overall IBS Symptom Relief - 50% Rule|"Weekly binary question (yes/no): Did you have satisfactory relief of your overall IBS symptoms since the last visit?~Responder: report of satisfactory overall IBS symptom relief = Yes 2/4 weeks (50% rule)"|Four weeks|Intention-to-Treat (N=544)|||Participants|||Number
1462620|NCT00760877|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Months||95% Confidence Interval|Median
1462621|NCT00760877|Secondary|Event-free Survival|Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.|48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Months||95% Confidence Interval|Median
1462622|NCT00760877|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.|48 months|24 months, Non-responders|||months||95% Confidence Interval|Median
1462623|NCT00760877|Secondary|Number of Cross-over Participants With CMR|The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 months, 48 months|Participants from the Imatinib treatment group who crossed over to the Nilotinib treatment group were analyzed.|||Participants|||Number
1462648|NCT00760669|Primary|Overall Efficacy Assessment|The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator’s discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion.|Baseline up to Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.|||Participants|||Number
1462762|NCT00759902|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1462624|NCT00760877|Secondary|Rate of Confirmed Best Cumulative CMR|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|24 months, 36 month, 48 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Participants|||Number
1462625|NCT00760877|Primary|Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)|The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date. Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders. Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders. The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.|12 months|The intent-to-treat analysis set, which included all randomized participants, was analyzed.|||Participants|||Number
1462626|NCT00760838|Secondary|Change in Total Score on the Asthma-related Quality of Life (AQLQ)|"A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease~32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items)~7-point Likert scale (7 = not impaired at all - 1 = severely impaired).~Scores range 1-7, with higher scores indicating better quality of life."|from baseline to week 26|intention to treat analysis|||units on a scale||Standard Deviation|Mean
1462627|NCT00760838|Secondary|Change in Total Score on Asthma Control Questionnaire (ACQ)|"A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.~ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff~Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%)~Scores range between 0 (totally controlled) and 6 (severely uncontrolled)."|from baseline to week 26|intention to treat analysis|||units on a scale||Standard Deviation|Mean
1462628|NCT00760838|Secondary|Change in Forced Expiratory Volume in 1 Second||from baseline to week 26|intention to treat analysis|||percentage of baseline FEV1||Standard Deviation|Mean
1462629|NCT00760838|Secondary|Peakflow Measurements|change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second|from baseline to week 26|intention to treat analysis|||L/min||Standard Deviation|Mean
1462630|NCT00760838|Secondary|Proportion of Participants Using Rescue Medication From Baseline to Week 26|"proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used.~This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26."|from baseline to week 26|intention to treat analysis|||proportion of participants||Standard Deviation|Mean
1462631|NCT00760838|Primary|Proportion of Participants With Severe Asthma Exacerbations|Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.|from baseline to week 26|intention to treat analysis|||proportion of participants||95% Confidence Interval|Mean
1462632|NCT00760747|Secondary|Number of Participants With Suicidal Behaviors and Ideations|Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.|Baseline through 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||participants|||Number
1462633|NCT00760747|Secondary|Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||kilogram||Standard Deviation|Mean
1462634|NCT00760747|Primary|Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 2 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1462635|NCT00760747|Secondary|Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint||Baseline, 6 weeks, 14 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.|||beats per minute||Standard Deviation|Mean
1462638|NCT00760747|Secondary|Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint|CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score– Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||standard deviation units||Standard Error|Least Squares Mean
1462639|NCT00760747|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint|The CGI- S is a single-item clinician rating of the severity of the participant’s ADHD symptoms in relation to the clinician’s total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1462640|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1462641|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1462642|NCT00760747|Secondary|Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint|The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1462643|NCT00760747|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint|Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.|Baseline, 10 weeks|Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.|||units on a scale||Standard Error|Least Squares Mean
1462644|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction|An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1462645|NCT00760669|Primary|Number of Participants With Adverse Drug Reactions|Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as “not related”.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1462646|NCT00760669|Primary|Number of Participants With Unexpected Adverse Events|Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1462647|NCT00760669|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 30|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
1462649|NCT00760669|Primary|Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30|The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 – 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline and Week 30|Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.||||||
1462650|NCT00760669|Primary|Change From Baseline in Number of Tender Joints at Week 30|Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Tender joints||Standard Deviation|Mean
1462651|NCT00760669|Primary|Change From Baseline in Number of Swollen Joints at Week 30|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Swollen joints||Standard Deviation|Mean
1462652|NCT00760669|Primary|Change From Baseline in C-Reactive Protein (CRP) at Week 30|The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure.|||Milligram per deciliter||Standard Deviation|Mean
1462653|NCT00760669|Primary|Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30|The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation.|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure.|||Millimeter per hour||Standard Deviation|Mean
1462654|NCT00760669|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30|The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline and Week 30|The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure.|||Millimeter||Standard Deviation|Mean
1462655|NCT00760617|Secondary|The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21|The markers assessed were CD4-ALL DOUBLES, CD40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.|||cells per million CD4 T-cells||Standard Deviation|Geometric Mean
1462656|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 180|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
1462657|NCT00760617|Secondary|The Number of Subjects Seroprotected to HI Antibodies at Day 0 and Day 21|Seroprotection was defined as the percentage of vaccinees with a serum HI titre ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
1462658|NCT00760617|Secondary|HI Antibody SCF at Day 180|SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||fold increase||95% Confidence Interval|Geometric Mean
1462660|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 180|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre <1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
1462661|NCT00760617|Secondary|The Number of Subjects Seroconverted to HI Antibodies at Day 21|Seroconversion was defined as the percentage of vaccinees who had either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre ≥1:40 or a pre-vaccination titre ≥1:10 and at least a 4-fold increase in post-vaccination titre. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
1462662|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 180|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||Participants|||Count of Participants
1462663|NCT00760617|Secondary|The Number of Subjects Seropositive to HI Antibodies at Day 0 and 21|Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||Participants|||Count of Participants
1462664|NCT00760617|Secondary|HI Antibody Titers at Day 180|Antibody titers were expressed as GMTs with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|Day 180|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.|||titers||95% Confidence Interval|Geometric Mean
1462665|NCT00760617|Secondary|Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21|Antibody titers were expressed as Geometric mean titres (GMTs) with separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.|At Day 0 and 21|Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.|||titer||95% Confidence Interval|Geometric Mean
1462666|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 180 to Day 209|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1462667|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1462668|NCT00760617|Primary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 to Day 20|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1462669|NCT00760617|Primary|Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID)|AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoiimune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1462670|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 21-179|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1462684|NCT00760552|Primary|Blood Pressure Change|Participant's Blood Pressure (BP) will be measured using a standard protocol following American Heart Association guidelines using an Omron HEM 907 device. The primary endpoint—BP—will be assessed using standard measurements at baseline, 6, 12, 18, 24, and 30 months post enrollment (24 months after randomization).|Measured at Baseline, and 6,12,18,24, and 30 months post baseline.||||mmHg||Standard Deviation|Mean
1462671|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20|For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1462672|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as possibly related to the study vaccination.|Day 0-20|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
1462673|NCT00760617|Primary|Duration of Solicited General AEs|Duration was defined as number of days with any grade of general symptoms.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1462674|NCT00760617|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature >40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to vaccination, grade 3 was defined as a general symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1462675|NCT00760617|Primary|Duration of Solicited Local AEs|Duration was defined as number of days with any grade of local symptoms and grade for quantifiable symptoms: ecchymosis, redness and swelling was greater than (>) 20mm.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
1462676|NCT00760617|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Grade 3 ecchymosis, redness and swelling was greater than or equal to 100 millimeter (mm) i.e. ≥ 100 mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.|Day 0-6|The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.|||Participants|||Count of Participants
1462677|NCT00760578|Post-Hoc|Change From Baseline in Insulin|Change from Baseline in insulin levels following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 pre-dose laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||uIU/mL||Standard Error|Least Squares Mean
1462678|NCT00760578|Post-Hoc|Change From Baseline in FPG|Change from baseline in fasting plasma glucose (FPG) following 28 days of active therapy|28 days|All patients who were compliant during the treatment period and who had Day 8 and Day 43 fasting plasma glucose values. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1462679|NCT00760578|Secondary|Change From Baseline in HDL|Change from baseline in HDL following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1462680|NCT00760578|Secondary|Change From Baseline in Triglycerides|Change compared to baseline in triglycerides following 28 days of active therapy, as part of a lipid profile assessment|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1462681|NCT00760578|Secondary|Change From Baseline in FFAs|Change from baseline in Free Fatty Acids (FFAs)following 28 days of active therapy, as part of a lipid profile assessment|After 28 days of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1462682|NCT00760578|Secondary|Change From Baseline in Averaged Insulin Levels in Response to a Mixed-meal Tolerance Test|Change from baseline in averaged post prandial insulin levels in response to a mixed-meal tolerance test.|After four weeks of active therapy|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance (MMT) test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||uIU/mL||Standard Error|Least Squares Mean
1462683|NCT00760578|Primary|Change From Baseline in Averaged Postprandial Glucose in Response to a MMT Test|Change from baseline of averaged postprandial glucose (mmol/L) in response to a Mixed-meal tolerance (MMT) test.|28 days|All patients who were compliant during the treatment period and who had a Day 8 and Day 43 averaged mixed-meal tolerance test and laboratory assessments. Compliance during the treatment period was determined by the sponsor through a manual review of pill counts, including a review of comments from the study sites.|||mmol/L||Standard Error|Least Squares Mean
1462685|NCT00760526|Secondary|Parental Quality of Life Measures: CGM Satisfaction Scale|"Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)~JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679–684"|26 weeks||||units on a scale||Standard Deviation|Mean
1462686|NCT00760526|Secondary|Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1–4. Higher score denotes fewer problems in the past month.|26 weeks||||units on a scale||Standard Deviation|Mean
1462687|NCT00760526|Secondary|Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)|The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.|26 weeks||||units on a scale||Standard Deviation|Mean
1462688|NCT00760526|Secondary|Parental Quality of Life Measures: Hypoglycemia Fear Survey|The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0–100 with higher score denoting more fear. The results reported below are the values at 26 weeks.|26 weeks||||units on a scale||Standard Deviation|Mean
1462689|NCT00760526|Secondary|Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)|Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||percentage of median||Inter-Quartile Range|Median
1462690|NCT00760526|Secondary|Measures of Variability: Mean Absolute Rate of Change|mean absolute rate of change|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||mg/dL per minute||Inter-Quartile Range|Median
1462691|NCT00760526|Secondary|Measures of Variability: Standard Deviation (SD)|standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|||mg/dL||Inter-Quartile Range|Median
1462692|NCT00760526|Secondary|Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.|26 weeks||||percentage of sensor readings||Inter-Quartile Range|Median
1462693|NCT00760526|Secondary|CGM Glucose Values (mg/dL)|Percentage of sensors values in range (71 mg/dL to 180 mg/dL)|26 weeks|CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data|||percentage of sensor readings||Inter-Quartile Range|Median
1462694|NCT00760526|Secondary|Number of Severe Hypoglycemic Events Experienced by Participants||26 weeks|Excludes one subject in the CGM group and one subject in the control group who dropped out of the study immediately after randomization.|||events|||Number
1462695|NCT00760526|Primary|Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events||26 weeks|Excludes five subjects in the CGM group and four in the control group who dropped out prior to the 26-week visit; for one subject who was missing central laboratory HbA1c values at randomization and one at 26 weeks, the DCA value measured at the site was used to impute values using repeated-measures regression models|||participants|||Number
1462696|NCT00760487|Secondary|IOL Rotation|Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.|6 months post-operative||||Percentage of Participants|||Number
1462697|NCT00760487|Secondary|Spectacle Independence|Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit|6 months post-operative||||Percentage of participants|||Number
1462698|NCT00760487|Primary|Visual Acuity (VA)|Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|Pre-operative, 1 month, 3 month, and 6 month post-operative||||logMAR||Standard Deviation|Mean
1462699|NCT00760474|Secondary|Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria|Participant rated severity of pain upon application of 4 kilograms (kg) pressure via dolorimeter at the bilateral epicondyle tender points (2 tender points, 2 centimeters distal to the epicondyles) described in the American College of Rheumatology (ACR) classification criteria and scored on a 0 (no pain) to 10 (worst possible pain) rating scale. Each arm was to be assessed for any pain (one point on each arm) with the application of pressure.|Day 58|FAS; N=number of participants with analyzable data at observation.|||scores on a scale||Standard Deviation|Mean
1462700|NCT00760474|Secondary|Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked|"BP cuff evoked allodynia assessed based on participant response to the following question When I take your blood pressure, tell me if the cuff's pressure is painful. A standard BP cuff was inflated at approximately 10 millimeters of mercury (mm Hg) per second up to 180 mm Hg or to point when participant experienced pain; performed 3 times on each arm whether or not pain was reported. If no pain elicited at 180 mm Hg, it was recorded that no sphygmomanometry-evoked allodynia occurred. If pain was reported, value (in mm Hg) at which pain first occured was recorded for each of the assessments."|Day 58|FAS; N=number of participants with analyzable data at observation.|||mm Hg||Standard Deviation|Mean
1462701|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by the participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12). Total (overall) score was sum of items 1 to 15, range 0 to 45; higher scores indicated higher pain/impact. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
1462702|NCT00760474|Other Pre-specified|Pain Catastrophizing Scale (PCS) Including Outliers|"PCS is a participant rated 13-item instrument to measure the presence and severity of catastrophizing. Scored 0 (not at all) to 4 (all the time) to statements such as When I'm in pain…I worry all the time about whether the pain will end. All 13 statements start with When I'm in pain…. Total score ranged from 0 to 52; higher scores reflected greater impairment. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier."|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462703|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
1462704|NCT00760474|Other Pre-specified|Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers|A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean.|||scores on a scale||Standard Error|Least Squares Mean
1462705|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462706|NCT00760474|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers|SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462707|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The individual daily pain score was defined as the final score recorded in the last pain diary of the treatment period 24 hours prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462708|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 3 day average pain score was defined as the mean daily pain NRS value for the last 3 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462709|NCT00760474|Secondary|Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers|The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 7 day average pain score was defined as the mean daily pain NRS value for the last 7 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462710|NCT00760474|Secondary|Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers|Minimum and maximum pain unpleasantness acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (neutral) to 20 (very intolerable). Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462711|NCT00760474|Secondary|Gracely Box Scales for Pain Intensity (GBSint) Including Outliers|Minimum and maximum pain intensity acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (no pain sensation) to 20 (extremely intense). Baseline and Post-dose data for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS|||scores on a scale||Standard Error|Least Squares Mean
1462712|NCT00760474|Secondary|Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions|Resting state brain activity assessed for correlation of brain seed region (pIns, anIns) to ROI connectivity at baseline (pre-dose) and post-dose (pre minus post) measured using z-score (mean of 0, standard deviation [SD] of 1); range approximately -3 to +3. Positive (+) z-scores reflect greater connectivity (+correlation between seed region and ROI). Negative (-) z-scores reflect -connectivity (anti-correlation between seed region and ROI). ROIs include PCC and IPL from within the default mode network (DMN). DMN is a constellation of regions in which connectivity is augmented in fibromyalgia.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Participants in FAS with quality resting state data (data able to be corrected for motion [head and cardiorespiratory artifacts]).|||z-score||Standard Deviation|Mean
1462713|NCT00760474|Secondary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined ROI brain regions in response to checkerboard visual stimuli (flashing at 8 hertz [Hz]). Reported as percent change between the pre-dose (baseline) and post-dose values.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS.|||percent change in BOLD signal||Standard Deviation|Mean
1462714|NCT00760474|Primary|Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers|BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC).|||percent change||Standard Error|Least Squares Mean
1462715|NCT00760474|Primary|Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)|Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine.|Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)|Full Analysis Set (FAS) all participants who received a minimum fixed dose of 300 mg/day of study treatment. N=number of participants with analyzable data at observation.|||ratio||Standard Deviation|Mean
1462716|NCT00760461|Primary|Gastroparesis Cardinal Symptom Index||upon study completion|Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated.||||||
1462717|NCT00760435|Secondary|Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm|left anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area|2 weeks||||Z-score||95% Confidence Interval|Mean
1462718|NCT00760435|Secondary|Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.||24 hours||||mg/dL||95% Confidence Interval|Mean
1462719|NCT00760435|Secondary|Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)||up to 6 weeks||||days||Inter-Quartile Range|Median
1462720|NCT00760435|Primary|The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion||10 weeks|1 subject in the placebo group was removed from the modified ITT analysis (this subject was removed from the study prior to receiving the placebo)|||participants|||Number
1462721|NCT00760383|Secondary|Mid-thigh Muscle Volume|Analysis was performed using the Analyze 11 software package with semi-automated delineation of quadriceps, hamstrings, and adductors boarders. Using thresholding methods, the software can differentiate operator-delineated parameters set to distinguish muscle from non-muscle (i.e., adipose tissue) using voxel intensity within each border region for quantitative determination of muscle volume.|6 weeks||||Volume (cm^3)||Standard Error|Mean
1462722|NCT00760383|Primary|Quadriceps Muscle Strength||6 weeks||||Newtons||Standard Error|Mean
1462726|NCT00760266|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8||Baseline and Week 8|Full analysis set, restricted for msDBP to those with baseline msDBP at least 90 mm Hg)|||mm Hg||Standard Error|Least Squares Mean
1462727|NCT00760266|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set, restricted to baseline msDBP >= 90 mmHg|||mm Hg||Standard Error|Least Squares Mean
1462728|NCT00760266|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4||Baseline and Week 4|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
1462729|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462730|NCT00760214|Secondary|Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in trough mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough mean is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462731|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462732|NCT00760214|Secondary|Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462733|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462734|NCT00760214|Secondary|Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in daytime (6am to 10pm) mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462735|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462736|NCT00760214|Secondary|Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462737|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean diastolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462738|NCT00760214|Secondary|Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.|The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 24.|Full Analysis Set.|||mmHg||Standard Error|Least Squares Mean
1462739|NCT00760214|Secondary|Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure|The change in mean trough clinic sitting diastolic blood pressure measured at final visit or week 24 relative to baseline. Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1462740|NCT00760214|Primary|Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.|The change in mean trough clinic sitting systolic blood pressure measured at final visit or week 24 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline and Week 24.|Full analysis set with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
1462741|NCT00760084|Primary|The Number of Subjects With Adverse Events|Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (< 30% blasts) or AML (> 30% blasts).|3 months||||participants|||Number
1462742|NCT00760019|Primary|Flow-mediated, Endothelium-dependent Vasodilation|Flow-mediated, endothelium-dependent vasodilation (percentage increase in brachial artery diameter after a 5 minute ischemic stimulus) measured at the end of placebo treatment and end of salsalate treatment were compared.|Upon completion of 4 weeks of salsalate and placebo treatment|The ultrasound data for two subjects was inadequate for analysis. This determination was made prior to unblinding. The data for these two subjects were discarded, leaving 56 subjects for analysis.|||percentage vasodilation||Inter-Quartile Range|Median
1462743|NCT00760006|Primary|Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty|Primary outcomes of fistula or delayed wound healing following palatoplasty were measured in two groups of patients. This outcome measure addresses both objectives noted in the summary of the study description.|We anticipate a minimum of less than 2 months to a maximum of 1 year for follow-up will be necessary to document either stage 1 healing or the presence of a palatal fistula in nearly all cases.|"Only participants receiving preoperative antibiotics are considered for this outcome measure. Please refer to the exclusion criteria listed in the initial protocol -- Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or placebo groups."|||Participants|||Count of Participants
1462744|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Markers of Inflammation||once the final participant has completed all intervention procedures, approx. 3 months||||pg/mL||Inter-Quartile Range|Median
1462745|NCT00759967|Secondary|To Determine Patient Modality Preference.|each participant will complete a questionaire regarding modality preference|at study completion|The trial did not include a questionnaire regarding modality preference as originally planned||||||
1462746|NCT00759967|Secondary|To Determine if the Enhance Control of Blood Pressure With Daily Hemodialysis Compare to Conventional Hemodialysis is Associated With a Reduction in Oxidative Stress.||once the final participant has completed all intervention procedures, approx. 3 months||||mmol/ml MDA equivalent||Inter-Quartile Range|Median
1462747|NCT00759967|Secondary|To Determine if Short Daily Hemodialysis, Compared to Conventional Hemodialysis Maintains Metabolic Homeostasis|Serum phosphate values from the end of the three month run in phase and after randomization used to measure metabolic homeostasis|once the last participant has completed run in phase and after randomization, approx. 3 months||||mmol/Litre||Standard Deviation|Mean
1462748|NCT00759967|Secondary|To Determine if the Mechanism by Which Short Daily Hemodialysis is Associated With Changes in Extracellular Fluid Volume|The extracellular fluid volume will be measured using bioelectrical impedance to determine if the mechanism by which short daily hemodialysis is associated with an improvement in blood pressure control is secondary to changes in extracellular fluid volume.|once the final participant has completed all intervention procedures, approx. 3 months||||Litres||Standard Deviation|Mean
1462749|NCT00759967|Primary|Mean Systolic Blood Pressure Over the Third Month of Each Treatment Arm|The average of 2 measurements taken pre each dialysis session in the third month of treatment were compared when the patients were on conventional hemodialysis compared to short daily hemodialysis. SBP was taken in accordance with guidelines from the Canadian Hypertension Society|Average of the last month of the 3 month intervention||||mm Hg||Standard Deviation|Mean
1462750|NCT00759954|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0, 2, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 12, 18, 24, 30, 36, and 48 hrs post dose||||ng*hr/mL||Standard Deviation|Mean
1462751|NCT00759954|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng*hr/mL||Standard Deviation|Mean
1462752|NCT00759954|Secondary|Time of Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose|Subjects completed the study without protocol violations.|||hour||Full Range|Median
1462753|NCT00759954|Primary|Maximum Plasma Morphine Concentration|calculated from drug concentration over time|2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
1462754|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months|Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1462755|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1462756|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1462757|NCT00759941|Primary|Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months|Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.|Day 0, 3 months|All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).|||mmHg||Standard Deviation|Mean
1462758|NCT00759915|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1462759|NCT00759915|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||hr*ng/mL||Standard Deviation|Mean
1462760|NCT00759915|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||Hr||Full Range|Median
1462761|NCT00759915|Primary|Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs||||ng/mL||Standard Deviation|Mean
1462766|NCT00759863|Secondary|Center for Epidemiologic Studies Depression Scale|The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The construct being assessed is the caregiver depression. Best value = 0. Worst Value = 60.|6 months||||Units on a scale||Standard Deviation|Mean
1462767|NCT00759863|Secondary|Revised Memory and Behavior Problems Checklist|This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this “bothered or upset” them. A “conditional bother” score is calculated which is the “upset” or “bother” ratings for only the problematic behavior that occurred. Best value = 0. Worst Value = 96.|6 months||||Units on a scale||Standard Deviation|Mean
1462768|NCT00759863|Primary|Multidimensional Observation Scale for Elderly Subject|"This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: Personal Care, Communication, Awareness & Memory, Mood, and Interpersonal Awareness Behaviors. The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144."|6 months||||Units on a scale||Standard Deviation|Mean
1462769|NCT00759811|Secondary|Incidence of Adverse Effects of the Treatment||12 weeks|||||||
1462770|NCT00759811|Secondary|Incidence of All Cause Mortality, Hospitalization for Worsening Heart Failure, Myocardial Infarct, Stroke or Myocardial Revascularization Need||12 weeks|||||||
1462771|NCT00759811|Secondary|Reduction of Inflammatory Marker Measured Using C-reactive Protein Blood Levels||12 weeks|||||||
1462772|NCT00759811|Secondary|Improve in Quality of Life Measured Using the Brazilian Edition SF-36||12 weeks|||||||
1462773|NCT00759811|Secondary|Improve in Heart Failure Functional Class Measured Using New York Heart Association||12 weeks|||||||
1462774|NCT00759811|Primary|Change in Physical Capacity Measured Using the 6-minute Walk Test Distance|The primary outcome of the study was the difference in 6MWT distance before and after the treatment (change in meters evaluated by t test).|Baseline and 12 weeks||||meters||Standard Deviation|Mean
1462775|NCT00759785|Secondary|Change From Baseline in IGF1R Membrane H-Score After a Single Dose of Dalotuzumab|IGF1R expression was measured in pre and post-dose biopsy samples using an immunohistochemistry assay. Results were expressed as an IGF1R membrane H-score. The H-score was calculated from the percentage of cells staining very weak (+/-); weak (1+); moderate (2+); or strong (3+) and obtained by the formula: (3 x percentage of strongly staining nuclei) + (2 x percentage of moderately staining nuclei) + (1 x percentage of weakly staining nuclei) + (0.5 x percentage of weakly staining nuclei). The H-score ranges from 0 to 300; with a score of 0 representing the absence of IGF1R expression and an H-score of 300 representing maximum IGF1R expression. A decrease in IGF1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement|Baseline and Up to 12 Days|All participants who received a single dose of dalotuzumab, had evaluable baseline and post-dose biopsy samples, and had H-score data available for pre- and post-dose measurements.|||H-score||Full Range|Mean
1462776|NCT00759785|Secondary|Percentage of IGF1R Negative Participants With a Decrease in GFS by Cohort|Biopsy samples were considered IGF1R negative if less than 10% of tumor cells stain. GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R negative at baseline, and had evaluable postdose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
1462777|NCT00759785|Secondary|Percentage of IGF1R Positive Participants With a Decrease in GFS by Cohort|Insulin-like Growth Factor Receptor Type 1 (IGF1R) expression was measured in pre-dose biopsy samples using an immunohistochemistry assay to establish baseline IGF1R positivity. Biopsy samples were considered IGF1R positive if at least 10% of tumor cells stain with intensity 1+ or greater based on staining criteria of very weak (+/-); weak (1+); moderate (2+); or strong (3+). GFS response was correlated with IGF1R expression for ER-positive luminal B and triple negative cohorts.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab, were IGF1R positive at baseline, and had evaluable postdose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
1462778|NCT00759785|Primary|Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)|GFS was measured by microarray analysis of the entire 101 gene signature expression. The GFS is quantified as the change in gene expression between two separate samples collected from the same participant. A log (base 10) ratio of expression in the post-dose sample was generated relative to the reference in both the Up and DOWN arms of the gene signature. A log ratio value of zero indicated no change in the expression between the two samples. GFS was calculated as the mean log ratio of genes in the UP arm minus mean log ratio of genes in the Down arm. GFS was compared for paired samples (pre-dose and post-dose) by a T-statistic calculated as the GFS divided by its standard error. Responders to therapy had a T-statistic that was smaller than the threshold 1st percentile of student's T-distribution and were counted as having a decrease in GFS.|Up to 12 Days Post-dose|All participants who received a single dose of dalotuzumab and had evaluable baseline and post-dose biopsy samples.|||Percentage of participants||80% Confidence Interval|Number
1462779|NCT00759772|Primary|Percent Change in Lumbar Spine Bone Mineral Density|Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)|Baseline and 6 months|All participants were included in analysis (intention to treat).|||percentage of change||Standard Error|Mean
1462780|NCT00759759|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1462781|NCT00759759|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36, 48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1462782|NCT00759759|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr||Full Range|Median
1462784|NCT00759707|Primary|Change From Baseline in Saphenous Vein Bypass Graft Vasodilation|Flow-mediated, endothelium-dependent vasodilation was determined by comparing baseline vein graft diameter with vein graft diameter as measured after deflation of a 2.5-inch wide sphygmomanometric cuff that had been inflated to suprasystolic pressure for 5 minutes. The cuff was never placed directly over the graft. Vasodilation of the vein graft was determined by acquiring images at 1 minute after cuff deflation.|Single visit study||||vein bypass graft size increase (%)||Standard Error|Mean
1462785|NCT00759681|Primary|Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response|The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.|Treatment through 6 weeks|Based on ITT population for primary safety analysis.|||participants|||Number
1462786|NCT00759681|Primary|Immediate Sealing Evidenced by no Bleeding on Clamp Release.|The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery|Immediate at time of surgery|Treatment sites were the unit of measure based on ITT for effectiveness outcomes.|||Treatment sites|Participants||Number
1462787|NCT00759668|Primary|Near Uncorrected Visual Acuity Right Eye (UCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1462788|NCT00759668|Primary|Near Best Corrected Visual Acuity Right Eye (BCVA RE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1462789|NCT00759668|Primary|Near Uncorrected Visual Acuity Left Eye (UCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1462790|NCT00759668|Primary|Near Best Corrected Visual Acuity Left Eye (BCVA LE)|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1462791|NCT00759668|Primary|Near Uncorrected Visual Acuity (UCVA) Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1462803|NCT00759577|Primary|Improvement in Patient Perception of Bladder Condition Score (PPBC)|Difference in Patient Perception of Bladder Condition (PPBC) score from start of medication to end of trial (12 weeks). This is a single item patient reported global question that assesses a patients subjective impression of the current urinary problems. The patients is asked to rate their perceived bladder condition on a 6 point scale ranging from 1 (no problem) at all to 6 (many severe problems). To assess change in PPBC the baseline value is subtracted from the end of study value. Thus changes in score typically range from -2 to 2. Negative values represent an improvement.|12 weeks|There was no questionnaire available for analysis. Secondary to poor enrollment the study was stopped and efforts to collect questionnaires at an earlier time point were not carried out.||||||
1462792|NCT00759668|Primary|Near Best Corrected Visual Acuity (BCVA) - Binocular|Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after second eye implantation|The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) & were converted to LogMAR after inclusion in the database leading to data approximations.|||Percentage of Participants|||Number
1462793|NCT00759655|Secondary|Mean Number of Breakthrough (Spontaneous/Non-traumatic) Bleeds|The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours following a prophylaxis dose of Xyntha was summarized. The data from the electronic Infusion Log Diary plus the Test Article CRF was used to determine the number of infusions administered to treat a new bleed, counting only those infusions administered =<48 hours after an infusion marked as 'prophylaxis' (which had no associated bleed).|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Bleeds|Participants|Standard Deviation|Mean
1462794|NCT00759655|Secondary|Response to First On-demand Xyntha Treatment for All New Bleeds as Assessed by the Caregiver|A 4-point response scale to be completed is as defined as follows: (Excellent: definite pain relief/improvement in signs of bleeding starting within 8 hrs after an infusion, with no additional infusion; Good: definite pain relief/improvement in signs of bleeding starting within 8 hrs or following the infusion; Moderate: probable/slight improvement starting after 8 hours following the infusion; No Response: no improvement at all between infusions).|Baseline to 24 months or early withdrawal|The study was terminated, analysis was not conducted.|||Scores on scale|||Number
1462795|NCT00759655|Secondary|Number of Xyntha Infusions Needed to Treat Each New Bleed|The data from the electronic Infusion Log Diary plus the Test Article case report form (CRF) was used to determine the number of infusions administered to treat a bleed. This was calculated by adding the initial ‘for a new bleed’ (on demand) infusion to any subsequent (on demand) infusions for the (same) ‘previously treated bleed’. An on-demand infusion for a ‘previously treated bleed’ was counted toward the bleed with the most recent start time prior to that infusion.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Infusions|Participants||Number
1462796|NCT00759655|Secondary|Mean Annualized Bleed Rate (ABR)|An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Number of Bleeds|Participants|Standard Deviation|Mean
1462797|NCT00759655|Primary|Percentage of Participants With Low Recovery LETE|The LETE could be considered lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of participants|||Number
1462798|NCT00759655|Primary|Percentage of Participants With LETE in the Prophylaxis Setting|The LETE in the prophylaxis setting was the occurrence of a bleed. LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (=<48 hours) after a regularly scheduled prophylactic dose of Xyntha (which was not used to treat a bleed) in the absence of confounding factors.|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of participants|||Number
1462799|NCT00759655|Primary|Percentage of Participants With Less Than Expected Therapeutic Effects (LETE) in the On-Demand Setting|"LETE in the on-demand setting was based on the response to the treatment of a bleeding episode. LETE in the on-demand setting occurred if the participant recorded 2 successive No Response ratings (indicated there was no improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsened) after 2 successive Xyntha infusions, respectively. The infusions was to be administered within 24 hours (=<24 hours) of each other for the treatment of the same bleeding event in the absence of confounding factor."|Baseline to 24 months or early withdrawal.|The study was terminated, analysis was not conducted.|||Percentage of Participants|||Number
1462800|NCT00759655|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitor Development|Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using Nijmegen modification of the Bethesda assay.|Baseline to 24 months or early withdrawal.|Intent-to-treat (ITT) population: Participants who had received at least 1 dose of Xyntha.|||Percentage of participants|||Number
1462801|NCT00759642|Primary|Progression Free Survival|Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.|12 months||||months||80% Confidence Interval|Median
1462802|NCT00759603|Primary|Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines|Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly & constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes>1500/µL, platelets>100,000/µL, hemoglobin>11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate & biopsy normocellular for age with <30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia & bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, &/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets>100,000/µL or 50% improvement; Hemoglobin>11.0 g/dL (untransfused) or 50% improvement.|Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.||||Percentage of Participants|||Number
1463654|NCT00753675|Secondary|Duration of Response (DOR)|DOR is defined from the date of first documentation of response until date of PD or death|up to 1032 days|ITT (best response of CR or PR only)|||Days||95% Confidence Interval|Median
1462804|NCT00759564|Secondary|Number of Participants With Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.|Baseline, 7-10 days after the last dose of study drug|Safety analysis set included all participants who received the study medication.|||participants|||Number
1462805|NCT00759564|Secondary|Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for abnormal ECG (12-lead) values were defined as: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent for baseline value of >200 msec and >=50% for baseline value of <=200 msec for PR interval, QRS interval >=200 msec; QT interval corrected using the Fridericia formula (QTcF) >=500 msec or increase of >45 msec.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1462806|NCT00759564|Secondary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg, >=20 mmHg maximum increase and decrease from baseline in same posture, heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1462807|NCT00759564|Secondary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 6/High Power Field [HPF]).|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1462808|NCT00759564|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 7-10 days after the last dose of study drug (up to 32 days)|Safety analysis set included all participants who received the study medication.|||participants|||Number
1462809|NCT00759564|Secondary|Concentration Versus Time Summary of Plasma Formate|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1462810|NCT00759564|Secondary|Concentration Versus Time Summary of 2-Ethylbutyric Acid|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|1, 3, 8 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1462811|NCT00759564|Secondary|Pharmacokinetics of CP-70429 and PF-03709270 Metabolites|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429 and metabolites.|0.5, 2, 4, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|Data was not collected for this outcome because the metabolite data for CP-70,429 and PF-03709270 were not analyzed as per change in planned analysis||||||
1462812|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1462813|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 1.0 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 1.0 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1462814|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following PF-03709270 Oral Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1462815|NCT00759564|Secondary|Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following Intravenous Dose|Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 microgram per milliliter (mcg/mL) at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1462816|NCT00759564|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCinf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1462817|NCT00759564|Secondary|Clearance (CL)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1462818|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following PF-03709270 Oral Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1462819|NCT00759564|Secondary|Terminal Elimination Half Life (t1/2) of CP-70429 Following CP-70,429 Intravenous Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
1462820|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following PF-03709270 Oral Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||L/hr||Standard Deviation|Geometric Mean
1462821|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70429 Following PF-03709270 Oral Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1462822|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following PF-03709270 Oral Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1462823|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following PF-03709270 Oral Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1462900|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Flow (FEF) 25−75% at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L/s||Full Range|Mean
1462824|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following PF-03709270 Oral Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
1462825|NCT00759564|Primary|Renal Clearance (CLr) of CP-70429 Following CP-70,429 Intravenous Dose|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||liter per hour (L/hr)||Standard Deviation|Geometric Mean
1462826|NCT00759564|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70,429 Following CP-70,429 Intravenous Dose|AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
1462827|NCT00759564|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following CP-70,429 Intravenous Dose|Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
1462828|NCT00759564|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following CP-70,429 Intravenous Dose||0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
1462829|NCT00759564|Primary|Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose|PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.|0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)|The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1462830|NCT00759525|Primary|Forearm Blood Flow|At the end of each 14-day intervention (Glycyrrhinitic acid or Placebo), vascular endothelial function was assessed by measuring forearm blood flow and comparing to Baseline. The outcome measure depicted below reflects the change in forearm blood flow from Baseline after completing the glycyrrhinitic acid regimen as well as the change in forearm blood flow from Baseline after taking the matching placebo.|Outcome was measured at the end of each study period (i.e. 14 days after Baseline measurements were taken)||||ml/100ml of tissue/min||Standard Error|Mean
1462831|NCT00759473|Primary|Subjective Craving of Cocaine|Average of participants' subjective measures of craving immediately following cue exposure at the one-week follow-up session. Participants rated craving on a 10 point analog scale ranging from 0 (not at all) to 10 (extremely).|two weeks|Data of participants who completed all cue exposure sessions and the one-week follow-up were analyzed.|||units on a scale||Standard Deviation|Mean
1462832|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.|"Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score.~The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome."|Randomization to week 4||||Participants|||Number
1462833|NCT00759395|Secondary|The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.|"Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Randomization to week 4||||Participants|||Number
1462834|NCT00759395|Secondary|Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).|"Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome.~Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression."|Week 4||||Units on a scale||Standard Error|Least Squares Mean
1462835|NCT00759395|Primary|Hamilton Rating Scale for Anxiety (HAM-A) Total Score.|The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.|Week 4||||Units on a scale||Standard Error|Least Squares Mean
1462836|NCT00759395|Primary|Hamilton Rating Scale for Depression (HAM-D) Total Score.|Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.|Week 4||||Units on a scale||Standard Error|Least Squares Mean
1462837|NCT00759356|Secondary|Area Under the Curve to Infinity for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1462838|NCT00759356|Secondary|Area Under the Curve to the Last Measurable Time Point for Plasma Morphine||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr*ng/mL||Standard Deviation|Mean
1462839|NCT00759356|Secondary|Time of Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||hr||Full Range|Median
1462840|NCT00759356|Primary|Mean Maximum Plasma Morphine Concentration||0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs post dose||||ng/mL||Standard Deviation|Mean
1462841|NCT00759330|Secondary|Patient Assessment of Wearability of Therapy|"At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where:~1 = Excellent, 4 = Poor."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||participants|||Number
1462842|NCT00759330|Secondary|Percentage of Patients Who Discontinued|The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.|Days 1 through Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||percentage of patients who discontinued|||Number
1462843|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The total amount (mg) of rescue medication used during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||mg||Standard Error|Least Squares Mean
1462844|NCT00759330|Secondary|Acetaminophen Used During the Tape Treatment Phase|The percentage of patients who used rescue medication during the tape treatment phase.|Day 1 through Day 7 of the tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||percentage of patients|||Number
1462845|NCT00759330|Secondary|Patient Global Impression of Change (PGIC)|"At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where:~1 = very much improved, 7 = very much worse."|Day 7|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||participants|||Number
1462846|NCT00759330|Secondary|Change From Baseline in Total Tender Point Examination Score|"At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where:~0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect."|Baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||units on a scale||Standard Error|Least Squares Mean
1462847|NCT00759330|Secondary|Percent Change From Baseline in Total Functional Rating Index (FRI)|"Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome.~FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where:~Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100.~A positive percent change indicates a favorable treatment effect."|baseline to Day 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).|||percent change from baseline||Standard Error|Least Squares Mean
1462848|NCT00759330|Secondary|Average Daily Categorical Pain Scale Scores|"Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where:~0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time.~Data are reported as the daily average categorical pain scale score by treatment group."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Deviation|Mean
1462849|NCT00759330|Secondary|Pain Intensity Difference (PID+)|"+PID = pre-treatment value at baseline – post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~A positive PID indicates a reduction in pain."|Days 1 through 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Error|Least Squares Mean
1462901|NCT00758706|Secondary|Change From Baseline in Inspiratory Capacity (IC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1462850|NCT00759330|Primary|Cumulative Summed Pain Intensity Difference (SPID+)|"The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.~Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient."|Days 4 and 7 of tape treatment phase|Reported data are based on Intent-to-Treat patient population.|||units on a scale||Standard Error|Least Squares Mean
1462851|NCT00759187|Primary|Dental Plaque Index|Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)|4-Day||||Units on a scale||Standard Deviation|Mean
1462852|NCT00759174|Other Pre-specified|Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows.|60-day period prior to onset of NAION symptoms|FAS population. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days or every week within 60 days prior to symptom onset.|||exposed weeks|Participants||Number
1462853|NCT00759174|Other Pre-specified|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|FAS included all participants who signed informed consent, were eligible for study and reported exposure to PDEi within 60 days prior to participant reported-onset of NAION symptoms. N (number of participants analyzed) represents Definite or Possible NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.|||exposed days|Participants||Number
1462854|NCT00759174|Primary|Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases|Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.|30-day period prior to onset of NAION symptoms|Full Analysis Set (FAS) included all participants who signed informed consent, were eligible for study, reported exposure to PDE5i within 60 days prior to participant-reported onset of NAION symptoms. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.|||exposed days|Participants||Number
1462855|NCT00759161|Secondary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 21 and 35 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque vs. vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 7,14, 21, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1462856|NCT00759161|Secondary|Change From Baseline in Plaque Elevation at Day 7,14, 21, 28 and 35|Plaque elevation is a scale to assess plaque severity. Investigator rated presence of plaque elevation on a severity scale ranging, from 0 (no plaque elevation) to 8 (very marked plaque elevation), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1462857|NCT00759161|Secondary|Change From Baseline in Scaling at Day 7,14, 21, 28 and 35|Scaling is a scale to assess plaque severity. Investigator rated the clinical appearance of scaling on a severity scale, ranging from 0 (no scaling on plaque) to 8 (very thick scales on plaque), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1462858|NCT00759161|Secondary|Change From Baseline in Erythema at Day 7,14, 21, 28 and 35|Erythema is used to assess plaque severity. Investigator rated the clinical appearance of erythema on a severity scale, ranging from 0 (no color on plaque, no erythema) to 8 (extreme red color on plaque, severe erythema), where higher score indicated more severe condition.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1462859|NCT00759161|Secondary|Change From Baseline in Overall Target Plaque Severity Score (OTPSS) at Day 7,14, 21, 28 and 35|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque.|Baseline (Day 1), Day 7,14, 21, 28, 35|ITT population included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1462902|NCT00758706|Secondary|Change From Baseline in Vital Capacity (VC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1462860|NCT00759161|Primary|Percentage of Participants With Greater Decrease in Overall Target Plaque Severity Score (OTPSS) at Day 28|OTPSS is a scale to assess plaque severity. Each target plaque was scored on a severity rating scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 28 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque versus (vs.) vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 28|ITT population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
1462861|NCT00759148|Secondary|Microbiological Success at the Day 4 (EOT)/Exit Visit|Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.|Day 4|MBITT Analysis Set|||percentage of subjects|||Number
1462862|NCT00759148|Primary|Clinical Cure at the Day 4 (EOT)/Exit Visit|Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.|Day 4|This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set).|||percentage of subjects|||Number
1462863|NCT00759109|Other Pre-specified|Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI) at Baseline|Liver tissues obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome.|Baseline|ITT population|||Score on a scale||Standard Deviation|Mean
1462864|NCT00759109|Secondary|Change in the Proliferating Cell Nuclear Antigen Labeling Index (PCNA-LI)|"PCNA-LI was measured at baseline and at 18 months of treatment, and the change in PCNA-LI was calculated.~To measure PCNA-LI, liver tissue samples obtained from biopsies were fixed and immunostained to detect PCNA. PCNA-LI is the percentage of immunohistochemically stained (PCNA positive) cells in 1,000 HCC cells counted. A higher PCNA-LI indicates a worse outcome."|Baseline and at 18 months of treatment|Participants with tissue biopsies at 18 months.|||Score on a scale||Standard Deviation|Mean
1462865|NCT00759109|Secondary|Number of Patients With a Virological Response Rate|"Virological Response rate was measured by the disappearance of Hepatitis C Virus from serum. Serum samples from participants were analyzed for the~presence of HCV-RNA using a qualitative polymerase chain reaction (PCR)."|Baseline and every year during 3 years of treatment|ITT population|||Participants|||Number
1462866|NCT00759109|Secondary|Survival Time of Participants|Survival time was defined as time from screening visit to the death of the participant and was studied with Kaplan-Meier and Log-rank tests. If a participant did not die, he or she was censored with the last available date.|During 3 years of treatment and 2 years of follow-up|ITT population|||Years||95% Confidence Interval|Median
1462867|NCT00759109|Secondary|Number of Participants With Development of Hepatic Decompensation|The development of hepatic decompensation, defined as worsening of the hepatic function as measured by Child Pugh Score. The Child Pugh score was calculated based on biochemical changes (changes in serum albumin, serum bilirubin, prothrombin time) and clinical impairment (ascites, encephalopathies) or both. Each of the 5 parameters was scored from 1-3, and the Child Pugh Score represented the total score. The maximum score was 15, and a score of 10-15 represents the worst outcome and a life expectancy of 1-3 years.|Baseline, During 3 years of treatment and 2 years of follow-up|ITT population|||Participants|||Number
1462868|NCT00759109|Primary|Number of Participants With the Development of Hepatocellular Carcinoma (HCC)|"Participants were tested for focal lesions by liver ultrasound and for AFP levels every 6 months the during study (treatment and follow-up).~The development of hepatocellular carcinoma was determined by:~the appearance of a focal lesion detected by liver ultrasound with metastases confirmed by fine needle biopsy, or~the appearance of a focal lesion detected by ultrasound + alphafetoprotein (AFP) levels in blood >400 ng/mL."|During 3 years of treatment and 2 years of follow-up|ITT population|||Participants|||Number
1462869|NCT00759096|Secondary|Contrast Sensitivity||6 months after sugery of the 2nd eye|||||||
1462870|NCT00759096|Primary|Near Uncorrected Visual Acuity(UCVA|Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.|6 months after surgery of 2nd eye||||logMAR||Standard Deviation|Mean
1462871|NCT00759031|Primary|Gingival Margin Plaque Index|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.|1 day||||Units on a scale||Standard Deviation|Mean
1462872|NCT00758862|Primary|Area Under the Curve (AUC(0-t)) by Amount of TD1414 Cream Used|"The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1462873|NCT00758862|Primary|Area Under the Curve by SIRS Score|"On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s).~The severity was to be recorded using the Severity of Infection Rating Scale (SIRS).~For the SIRS, the following seven clinical signs/symptoms of infection were assessed:~Exudates/pus, Crusting, Erythema, Oedema, Tissue warmth, Itching and Pain.~Each of the seven signs/symptoms was scored using the following scale:~0 = absent 2 = mild 4 = moderate 6 = severe~The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1462903|NCT00758706|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1462874|NCT00758862|Primary|Area Under the Curve by Baseline Lesion Size|"On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm².~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1462875|NCT00758862|Primary|Area Under the Curve (AUC(0-t))|"Area under the concentration-time curve (AUC(0-t)) from time 0 to time of last non-zero observation after dosing, calculated by linear/log trapezoidal method.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||h*pg/mL||Standard Deviation|Geometric Mean
1462876|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by Amount of TD1414 Cream Used|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1462877|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by SIRS Score|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|AUC(0-t) could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1462878|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax ) by Baseline Lesion Size|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1462879|NCT00758862|Primary|Time to Reach Peak Serum Concentration (Tmax )|Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses.|From 0 hours to 240 hours|Tmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||hours||Standard Deviation|Median
1462880|NCT00758862|Primary|Peak Serum Concentration by Amount of TD1414 Cream Used|"The weight of TD1414 cream used was calculated by subtracting the weight of the used dispensed tube from the mean weight of a full tube.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1462881|NCT00758862|Primary|Peak Serum Concentration by SIRS Score|"On Day 1 (before the first application), the (sub)investigator recorded the severity of the lesion(s).~The severity was to be recorded using the Severity of Infection Rating Scale (SIRS).~For the SIRS, the following seven clinical signs/symptoms of infection were assessed:~Exudates/pus Crusting Erythema Oedema Tissue warmth Itching Pain~Each of the seven signs/symptoms was scored using the following scale:~0 = absent 2 = mild 4 = moderate 6 = severe The scores for each sign/symptom were summed to give the total SIRS score. The total SIRS score could range from 0 to 42.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1462882|NCT00758862|Primary|Peak Serum Concentration by Baseline Lesion Size|"On Day 1 (before the first application), the (sub)investigator recorded the size of the lesion(s). For each participant the size of the lesion was allocated to one of two categories: ≤15cm² or >15cm². The Cmax is presented by baseline lesion size category (≤15 cm² and >15 cm²).~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1462883|NCT00758862|Primary|Peak TD1414 Serum Concentration (Cmax )|"The Cmax was summarised by lesion size at baseline, by SIRS scores at baseline and by amount of TD1414 cream used.~Please see 1. Primary Outcome for details on collection of blood samples for the Pharmacokinetic analyses. For description of lesion size, SIRS score and amount of TD1414 cream used please see outcome measure 3, 4 and 5 respectively."|From 0 hours to 240 hours|Cmax could not be calculated for one participant as all values below lower limit of quantification (TD1414 concentration = 50pg/mL).|||pg/mL||Standard Deviation|Geometric Mean
1462884|NCT00758862|Primary|TD1414 Serum Concentration by Timepoint|On Days 1 and 2(and possibly Day 3 depending on the time of first application on Day 1) a sample was taken for pharmacokinetic(PK) analysis at any time before first application on Day 1, and at 12±1, 18±1, 24±1 and 36±4 hours after first application. If the 36±4 hours sampling time fell on Day 3, then a second sample was also required on Day 3, but was to be obtained at 6pm or afterwards. On Days 3 to 6(and also Day 7 if the very last application fell on Day 8), one sample was taken on each day at any time during the day. On Days 7 and 8(or Days 8 and 9 if very last application was on Day 8), a sample was taken immediately before the very last application and at 6±1, 12±1 and 24±2 hours after the very last application. On Days 9 and 10, one sample was taken on each day at any time during the day. If the participant had already had a sample(s) taken on Day 9 because the timing of some of the post-last application samples fell on this day, then further samples were not required on Day 9|From 0 hours to 240 hours|One participant withdrew at day 3 due to the participant being out of range of the inclusion criterion.|||pg/mL||Standard Deviation|Mean
1462885|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 14 days post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).|||participants|||Number
1462904|NCT00758706|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.|Baseline and Week 6|Full analysis set completed at week 6|||L||Full Range|Mean
1462886|NCT00758836|Primary|Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 48 hours post-dose|All participants as treated (one participant assigned to the Telcagepant 280 mg arm only took the placebo tablet and is included in the Placebo arm for adverse event reporting).|||Participants|||Number
1462887|NCT00758836|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose.|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0).|2 hours post-dose|The FAS comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.|||Percentage of Participants|||Number
1462888|NCT00758836|Primary|Percentage of Participants With Pain Freedom at Two Hours Post-dose|Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0).|2 hours post-dose|The Full Analysis Set (FAS) comprised participants who were treated and had a baseline assessment and at least one post-dose assessment up to or including the 2-hour time point. Missing data were imputed by using a Last Observation Carried Forward (LOCF) approach; baseline values were not carried forward to impute the missing post-treatment data.|||Percentage of Participants|||Number
1462889|NCT00758771|Primary|Shear Rheology|Baseline measure of sputum shear rheology|Cross-sectional||||Pascal||Standard Error|Mean
1462890|NCT00758758|Primary|Neck Disability Index (NDI)|"The Neck Disability Index (NDI) is an instrument used for testing self-rated disability in neck pain patients. The Neck Disability Index (NDI) consists of 10 questions, each with a score up to 5, for a total score of 50. The lower the score, the less self-rated disability.~NDI scoring:~0 – 4 = No disability~5 – 14 = Mild disability~15 – 24 = Moderate disability~25 – 34 = Severe disability~35 or over = Complete disability"|12 Months||||units on a scale||Standard Deviation|Mean
1462891|NCT00758758|Primary|Overall Clinical Success (NDI, Fusion, Additional Surgical Procedures)|Success was defined as an improvement in patient functional capability using the Neck Disability Index (NDI) by at least 10% as compared to the pre-operative evaluation and Radiographic evidence of fusion (< 3mm translation; < 5° angular motion and absence of radiolucent lines around ≥ 50% of the device)and A comparison of the incidence of intraoperative and postoperative complications which resulted in additional surgical procedures of revision, removal or supplemental fixation at 12 months|12 Months||||participants|||Number
1462892|NCT00758745|Primary|Posterior Capsule Opacification (PCO)|Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.|Up to 3 years||||Units on a scale||Standard Deviation|Mean
1462893|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Night Time Awakenings at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1462894|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Cough Score at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1462895|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Chest Tightness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1462896|NCT00758706|Secondary|Change From Baseline in COPD Symptoms, Breathlessness at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||Score on scale||Full Range|Mean
1462897|NCT00758706|Secondary|Change From Baseline in Clinical COPD Questionnaire(CCQ) Total|Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Baseline and Week 6|Full analysis set|||Score on scale||Full Range|Mean
1462898|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Evening at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||L/min||Full Range|Mean
1462899|NCT00758706|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) Morning at Average of Last 4 Week Treatment|Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.|Baseline and last 4 week on treatment(Week 1, Week 2, Week 4 and Week 6)|Full analysis set|||L/min||Full Range|Mean
1462905|NCT00758706|Secondary|Incidence of Adverse Events|Number of patients who had an AE|all study visits||||Participants|||Number
1462906|NCT00758706|Primary|Ratio of Total Urine Desmosine at Week 6 to Baseline|Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
1462907|NCT00758706|Primary|Ratio of Sputum Total Cells at Week 6 to Baseline|Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
1462908|NCT00758706|Primary|Ratio of TNF Alpha at Week 6 to Baseline|Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).|Baseline and Week 6|Full analysis set excluded participants without baseline or post-baseline data.|||ratio||Full Range|Mean
1462909|NCT00758680|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug|||participants|||Number
1462910|NCT00758680|Secondary|Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)|Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).|Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)|Per-Protocol Population; subset of participants who complied with the protocol sufficiently in terms of considerations as exposure to treatment, availability of measurements and absence of major protocol violations.|||mg/dL||Standard Deviation|Least Squares Mean
1462911|NCT00758680|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.|From Day 1 through the end of poststudy period (up to Day 25)|All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug|||participants|||Number
1462912|NCT00758667|Secondary|Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care||one year||||participants|||Number
1462913|NCT00758667|Primary|Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care||one year||||participants|||Number
1462914|NCT00758602|Secondary|Glomerular Filtration Rate (GFR) (mL/Min)|The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
1462915|NCT00758602|Secondary|Serum Creatinine (Micromoles Per Liter [µmol/L])|The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.|||µmol/L||Standard Deviation|Mean
1462916|NCT00758602|Secondary|Participant and Graft Survival|The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.|Months 6 and 12|ITT population|||percentage of participants|||Number
1462917|NCT00758602|Secondary|Percentage of Participants With Treatment Failure at 12 Months Post-Transplant|Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.|Month 12|ITT population|||percentage of participants|||Number
1462918|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant|The median time, in days, between randomization and acute rejection.|BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population|||days||95% Confidence Interval|Median
1462919|NCT00758602|Secondary|Time to First Acute Rejection Post-Transplant - Number of Participants With an Event||BL, Weeks 2, 4, 13, 26, 39, and 52|ITT population|||participants|||Number
1462920|NCT00758602|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant||Months 6 and 12|ITT population|||percentage of participants|||Number
1462921|NCT00758602|Primary|Glomerular Filtration Rate (GFR) at Month 12 After Transplantation|GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].|Month 12|ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.|||mL/min||Standard Deviation|Mean
1462938|NCT00758576|Primary|Uncorrected Near Visual Acuity|Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
1463291|NCT00755807|Secondary|Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)||Baseline (6 weeks) through Endpoint (18 weeks)|All participants randomized to placebo in acute phase received duloxetine during the extension phase.|||participants|||Number
1462922|NCT00758602|Primary|Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation|CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.|Month 12|ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.|||score on a scale||Standard Deviation|Mean
1462923|NCT00758589|Secondary|Adverse Event (AE)|Number of patients reporting at least one event|4 weeks||||Participants|||Number
1462924|NCT00758589|Secondary|Asthma Control Questionnaire 5 Items (ACQ5)|Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Full Range|Mean
1462925|NCT00758589|Secondary|Forced Vital Capacity (FVC) at the Clinic|Mean FVC during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1462926|NCT00758589|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at the Clinic|Mean FEV1 during the treatment period (mean value at Week 4)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1462927|NCT00758589|Secondary|Reliever Free Day|Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1462928|NCT00758589|Secondary|Symptom Free Day|Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1462929|NCT00758589|Secondary|Asthma Control Day|Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1462930|NCT00758589|Secondary|Awakenings|Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Percentage of days||Standard Deviation|Mean
1462931|NCT00758589|Secondary|Day-time Asthma Symptom Score|Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Standard Deviation|Mean
1462932|NCT00758589|Secondary|Night-time Asthma Symptom Score|Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Scores on a scale||Standard Deviation|Mean
1462933|NCT00758589|Secondary|Total Use of Reliever|Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||Number of inhalations per day||Standard Deviation|Mean
1462934|NCT00758589|Secondary|Evening Forced Expiratory Volume in 1 Second (eFEV1)|Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1462935|NCT00758589|Secondary|Morning Forced Expiratory Volume in 1 Second (mFEV1)|Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L||Standard Deviation|Mean
1462936|NCT00758589|Secondary|Evening Peak Expiratory Flow (ePEF)|Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Standard Deviation|Mean
1462937|NCT00758589|Primary|Morning Peak Expiratory Flow (mPEF)|Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)|Week 4|The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.|||L/min||Standard Deviation|Mean
1462939|NCT00758576|Primary|Uncorrected Distance Visual Acuity|Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
1462940|NCT00758576|Primary|Uncorrected Intermediate Visual Acuity|Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.|1 year after surgery|One patient dropped out after the visit 6 months following surgery but before the 1 year visit.|||Decimal Visual Acuity||Full Range|Mean
1462941|NCT00758563|Primary|Mean Gingival Plaque Units|Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque).|1 day||||Units on a scale||Standard Deviation|Mean
1462942|NCT00758550|Secondary|Questionnaire Results|Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).|6 Months||||Units on a scale||Standard Error|Mean
1462943|NCT00758550|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 Months after surgery||||logMAR||Standard Deviation|Mean
1462944|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Wake Time After Sleep Onset as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean wake time after sleep onset (time spent awake from sleep onset to final awakening) from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
1462945|NCT00758498|Secondary|Mean Change in Sleep Efficiency From Baseline To Endpoint as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean sleep efficiency from Baseline to Day 2 as recorded by nocturnal polysomnography. Sleep efficiency is defined as the ratio of time spent asleep (total sleep time) to the amount of time in bed.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Percent||Standard Deviation|Mean
1462946|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Latency to Persistent Sleep as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean latency to persistent sleep from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
1462947|NCT00758498|Secondary|Mean Change From Baseline to Endpoint in Total Sleep Time as Measured by Nocturnal Polysomnography|Nocturnal Polysomnography records normal and abnormal physiological activity during an entire night's sleep. It documents the adequacy of sleep, including frequency duration, and total amount of stage 1-2, stage 3-4 (slow wave sleep), rapid eye movement sleep, and apnea/hypopnea index. Data presented here represents the difference in mean total sleep time overnight from Baseline to Day 2 as recorded by nocturnal polysomnography.|Baseline and Day 2 (Endpoint)|Safety analysis population defined as all subjects who had at least one dose of study drug and underwent nocturnal polysomnography at Baseline and Day 2|||Minutes||Standard Deviation|Mean
1462948|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 3|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales: state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 3 is presented here.|Day 3|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 3|||Units on a scale||Standard Deviation|Mean
1462949|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 2|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 2 is presented here.|Day 2|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 2|||Units on a scale||Standard Deviation|Mean
1462981|NCT00758459|Secondary|Forced Expiratory Flow (FEF)25−75%|Change in FEF from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L/s||Full Range|Mean
1462982|NCT00758459|Secondary|Inspiratory Capacity (IC)|Change in IC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1462983|NCT00758459|Secondary|Vital Capacity (VC)|Change in VC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1462950|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Day 1|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to Day 1 is presented here.|Day 1|Safety analysis population defined as all subjects who had at least one dose of study drug and completed the State and Trait Anxiety Inventory Assessment at Baseline and Day 1|||Units on a scale||Standard Deviation|Mean
1462951|NCT00758498|Secondary|Change in State and Trait Anxiety Inventory Total Score From Baseline to Endpoint|The State and Trait Anxiety Inventory is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of 2 scales, state anxiety, which evaluates how the subject feels currently (transient anxiety), and trait anxiety, which evaluates how the subject feels generally (general tendency towards anxiety). Each scale consists of 20 questions, and a higher score indicates greater anxiety. Scores range from 20 (no anxiety) to 80 (maximum anxiety). The change in total score from Baseline to endpoint is presented here.|Endpoint defined as either Day 3 or last observation after baseline|Safety analysis population defined as all subjects who had at least one dose of study drug and one State and Trait Anxiety Inventory Assessment after Baseline|||Units on a scale||Standard Deviation|Mean
1462952|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 3|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 3 is presented here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
1462953|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 2|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 2 is presented here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
1462954|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Day 1|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at day 1 is presented here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||units on a scale||Standard Error|Least Squares Mean
1462955|NCT00758498|Secondary|Mean Patient Global Impression of Severity of General Condition Ratings at Baseline|"The PGI-S rating scale is the patient's assessment of general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers to symptoms of jet lag including excessive sleepiness, irritability, malaise, gastrointestinal disturbance, and poor performance. The least squares mean of PGI-S ratings at Baseline is presented here."|Baseline, prior to start of study drug dosing|Full analysis set defined as all subjects who received at least one dose of study drug and had a baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1462956|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 3|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 3 is presented here.|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1462957|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 2|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least Squares Mean sleep latency from the MSLT at day 2 is presented here.|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1462984|NCT00758459|Secondary|Forced Vital Capacity (FVC)|Change in FVC from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1462985|NCT00758459|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Change in FEV1 from baseline to end of treatment|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||L||Full Range|Mean
1462986|NCT00758459|Primary|Incidence of Adverse Events|Number of patients who had an Adverse Event|all study visits||||Participants|||Number
1496196|NCT00504556|Secondary|Effects on Biomarker D-dimer|Mean (SD) change from baseline in D-dimer|3 months||||ng/mL||Standard Deviation|Mean
1462958|NCT00758498|Secondary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Tests (MSLT) at Day 1|MSLT measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Least squares mean sleep latency from the MSLT at day 1 is presented here.|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1462959|NCT00758498|Secondary|Mean Ratings From the Mean Sleep Latency of the Multiple Sleep Latency Tests (MSLT) at Baseline|MSLT measures the likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep (in minutes). On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-sec epochs of stage 1 sleep were reached, or any 30 sec epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 min if no sleep occurred. Sleep latency was measured from lights out to first epoch scored as sleep. Mean sleep latency from the MSLT at Baseline (Screening Day 2) is presented here.|Baseline defined as Screening Visit 2 within 8 weeks prior to Treatment Day 1||||Minutes||Standard Deviation|Mean
1462960|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 3, collected only at bedtime, is reported here."|Day 3 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1462961|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 2, collected only at bedtime, is reported here."|Day 2 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1462962|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured on day 1, collected only at bedtime, is reported here."|Day 1 bedtime|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1462963|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) Collected at Bedtime at Baseline|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS mean score as measured at Baseline, collected at bedtime, is reported here."|Baseline prior to starting study medication|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1462964|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 3|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score as measured on day 3 is reported here."|Day 3|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1462965|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 2|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS Least squares mean score as measured on day 2 is reported here."|Day 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1462966|NCT00758498|Secondary|Mean Scores From the Karolinska Sleepiness Scale (KSS) at Day 1|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across day 1 is reported here."|Day 1|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1462967|NCT00758498|Secondary|Average of Scores Across Days 1 and 2 in the Karolinska Sleepiness Scale (KSS)|"The Karolinska Sleepiness Scale is a validated subject-rated instrument for measuring sleepiness, based on a scale from 1 to 9 (with 1 indicating very alert and 9 indicating very sleepy, great effort to stay awake, fighting sleep).~The KSS was administered 5 times during the day; before each MSLT nap and before bedtime. The KSS least squares mean score across days 1 and 2 are reported here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1463307|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase||Baseline through 6 weeks|All randomized participants.|||participants|||Number
1462968|NCT00758498|Primary|Average of Patient Global Impression of Severity (PGI-S) of General Condition Ratings Across Days 1 and 2|"The PGI-S rating scale is the patient's assessment of their general condition. The subject rates their overall condition according to the 7 following categories: 1=normal (no sign of illness), 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill. The term ill refers here to any symptoms of jet lag and overall feeling. Symptoms may include sleepiness, irritability, malaise, gastrointestinal disturbance, and level of performance. The average of PGI-S ratings across days 1 and 2 are presented here."|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Least Squares Mean
1462969|NCT00758498|Primary|Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2|MSLT is an assessment that measures likelihood of falling asleep. Mean Sleep Latency measures the time to fall asleep. On Treatment Days 1 and 2 the subject was instructed on 4 occasions to attempt to fall asleep. Each MSLT nap continued until 3 consecutive 30-second epochs of stage 1 sleep were reached, or any 30 second epoch of stage 2, 3, 4 or rapid eye movement sleep was reached. Each nap was terminated after 20 minutes if no sleep occured. Average sleep latency for the 4 naps was tabulated across days 1 and 2. Sleep latency was measured from lights out to first epoch scored as sleep.|Days 1 and 2|Full analysis set defined as all subjects who received at least one dose of study drug and had at least one post-baseline efficacy measurement|||Minutes||Standard Error|Least Squares Mean
1462970|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1462971|NCT00758485|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating a greater recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes)|The ITT Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1462972|NCT00758485|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (a percentage that is expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB), with a higher ratio indicating a greater recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >=0.9, the minimum acceptable ratio that indicated complete recovery from NMB. A shorter time to recovery of the T4/T1 Ratio >=0.9 indicates a faster recovery from NMB.|From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)|The Intent-to-Treat (ITT) Population consisted of all participants who received either Sugammadex or Placebo and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1462973|NCT00758459|Secondary|6-minute Walk Test|Change from baseline to end of treatment|Before treatment and after 6 weeks of treatment||||m||Full Range|Mean
1462974|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings|Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Score on scale||Full Range|Mean
1462975|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score|Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Scores on a Scale||Full Range|Mean
1462976|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness|Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Scores on a Scale||Full Range|Mean
1462977|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness|Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)|Daily during run-in and treatment||||Score on scale||Full Range|Mean
1462978|NCT00758459|Secondary|Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total|Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)|Before treatment and after 1, 2, 4 and 6 weeks of treatment||||Score on scale||Full Range|Mean
1462979|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Evening|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
1462980|NCT00758459|Secondary|Peak Expiratory Flow (PEF) Morning|Change in PEF from average during run-in to average during the last 4 w of treatment|Daily during run-in and treatment||||L/min||Full Range|Mean
1462987|NCT00758420|Primary|The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks|The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4.|Baseline to 8 weeks||||units on a scale||Standard Error|Least Squares Mean
1462988|NCT00758394|Primary|Dental Plaque Index|plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.|4-Day||||Units on a scale||Standard Deviation|Mean
1462989|NCT00758342|Primary|Mean IOP (Intraocular Pressure)||Screening: Week 12; (At 9 am and 4 pm time points)||||mm Hg (millimeters mercury)||Standard Deviation|Mean
1462990|NCT00758290|Primary|Dental Plaque Index|Plaque units measured on a scale between 0 to 5. No plaque=0;5=2/3 of tooth covered in plaque|4 Day||||Units on a scale||Standard Deviation|Mean
1462991|NCT00758264|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1462992|NCT00758264|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1462993|NCT00758264|Secondary|Number of Subjects Reporting Rash|Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1462994|NCT00758264|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the entire study duration (Day 0-Month 7)|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1462995|NCT00758264|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Day 0-30) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1462996|NCT00758264|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 4-day (Days 0-3) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.|||Participants|||Count of Participants
1462997|NCT00758264|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|Within the 4-day (Days 0-3) post-vaccination period after each dose|The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.|||Participants|||Count of Participants
1462998|NCT00758264|Secondary|Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1462999|NCT00758264|Secondary|Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1463000|NCT00758264|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1463031|NCT00757848|Secondary|Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463001|NCT00758264|Secondary|Anti-protein D (Anti-PD) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1463002|NCT00758264|Secondary|Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes|Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1463003|NCT00758264|Secondary|Opsonophagocytic Titers Against Pneumococcal Serotypes|Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
1463004|NCT00758264|Secondary|Cross-reactive Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1463005|NCT00758264|Secondary|Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.|Before vaccination (PRE) and at one month post dose 2 (Month 2)|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
1463006|NCT00758264|Primary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers|Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.|||Titers||95% Confidence Interval|Geometric Mean
1463007|NCT00758264|Primary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value|The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Nimenrix Group.|||Participants|||Count of Participants
1463008|NCT00758264|Primary|Anti-pneumococcal Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).|At Month 1|The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Synflorix Group.|||μg/mL||95% Confidence Interval|Geometric Mean
1463009|NCT00758160|Other Pre-specified|Global Assessment of Satisfaction by Participant|Participants were asked to assess their satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463010|NCT00758160|Secondary|Global Assessment of Satisfaction by Parents/Caregivers|Parents/caregivers were asked to assess the satisfaction with respect to ADHD treatment on a 5-point scale ranging from 1 to 5 where 1=completely dissatisfied, 2=somewhat dissatisfied, 3=neutral, 4=somewhat satisfied, and 5=completely satisfied.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463032|NCT00757848|Secondary|Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline|Ratio of day 28 to baseline|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463011|NCT00758160|Secondary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score|CGI-I is a single item assessment of the global improvement of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Improvement is rated on a 7-point scale (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse).|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Participants|||Number
1463012|NCT00758160|Secondary|Clinical Global Impression-Severity (CGI-S) Score|CGI-ADHD-S is a single item assessment of the global severity of ADHD symptoms in relation to the clinician’s total experience after reviewing all the returned questionnaires and clinical assessment of participants’ behavioral symptoms. Severity is rated on a 7-point scale ranging from 1 to 7 with 1=normal (not at all ill) and 7=most extremely ill.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463013|NCT00758160|Secondary|Social Adjustment Scale Score for Children and Adolescents (SAICA)|SAICA is a 77-item semi-structured interview scale designed for administration to school-aged children with age 6-18 years, or to their parents about their children. SAICA provides an evaluation of children’s current functioning in the domains of school, spare time, peer relations, and home behaviors. Each item ranged on a 4-point likert scale ranging from 1 to 4 with a higher mean score indicating either poorer social function or a more severe social problem.|Baseline, Week 4 and Week 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463014|NCT00758160|Secondary|Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Teachers) Score|Teachers were asked to assess the children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21.|Baseline, Week 2, 4 and 8|ITT analysis set included of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463015|NCT00758160|Secondary|Chinese Version of the Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR-C) Score|Parents of the participants were asked to assess the Family APGAR which is a 5-item questionnaire designed to assess the 5 dimensions of perceived family support: Adaptation, Partnership, Growth, Affection, and Resolve. Each item is rated on a 3-point scale ranging from 0 to 2 where 0=hardly ever, 1=some of the time and 2=almost always. The total score ranges from 0 to 10 with greater scores indicating greater family support.|Baseline, Week 4 and 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463016|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 8|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 8 minus mean CHQ score at Baseline.|Baseline and Week 8|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463017|NCT00758160|Primary|Mean Change From Baseline in Chinese Health Questionnaire (CHQ) at Week 4|The CHQ is a self administered screening instrument used to assess psychiatric morbidity in the Chinese community. It was derived from the General Health Questionnaire, and has been validated with satisfactory construct validity and applied in the survey of psychiatric morbidity in the community and in hospital settings. Four factors are included in the structure: somatic symptoms; anxiety and worrying; sleep problems; and depression and poor family relationships. It contains 12 items, with a maximum score of 12. CHQ scores indicated the severity of participants’ psychological problems (0–2=normal; 3–4=minor; 5–6=moderate; and 7–12=severe psychological problems). Mean Change was calculated as mean CHQ score at Week 4 minus mean CHQ score at Baseline.|Baseline and Week 4|ITT analysis set included parents of all the participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463058|NCT00757822|Primary|Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea (PON) and postoperative vomiting (POV) was assessed during Post-operative Care Unit (PACU) stay.|Post-operative Care Unit (PACU) length of stay on day of surgery (time from end of surgery to transfer to discharge unit or other hospital unit)|Per protocol|||percentage of participants|||Number
1463018|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 8|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 8 minus mean SNAP-IV score at Baseline.|Baseline and Week 8|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
1463019|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 4|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 4 minus mean SNAP-IV score at Baseline.|Baseline and Week 4|ITT analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
1463020|NCT00758160|Primary|Mean Change From Baseline in Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) Rating Scale (Parents) Score at Week 2|Parents were asked to assess their children on a 26-item Chinese SNAP-IV questionnaire consisting of inattention (items 1-9; subscore range 0-27), hyperactivity (items 10-18; subscore range 0-27) and oppositional (19-26, subscore range 0-24) subscales used to assess the qualitative judgments in Attention Deficit Hyperactivity Disorder (ADHD). Each item was based on a 4-point likert scale ranging from 0 (not at all) to 3 (very much). The overall score ranged from 0 to 78. The total score for Inattention and hyperactivity ranged from 0 to 27 and for oppositional ranged from 0 to 21. Mean Change was calculated as mean SNAP-IV score at Week 2 minus mean SNAP-IV score at Baseline.|Baseline and Week 2|Intent-to-treat (ITT) analysis set included all participants who received OROS-MPH at least once and provided at least 1 post-baseline efficacy measurement. Here, 'n' included those participants who were evaluable for this measure at the specified time point.|||Units on a scale||Standard Deviation|Mean
1463021|NCT00758069|Secondary|Change From Baseline in Plasma Glucose|Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1463022|NCT00758069|Primary|Change From Baseline in 24-hour Weighted Mean Plasma Glucose|Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.|Baseline and Week 4|The Per Protocol population included patients with baseline and Week 4 (i.e., final primary timepoint) values for this outcome and excluded patients who met predefined criteria for protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
1463023|NCT00758043|Secondary|Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments||Week 72|||||||
1463024|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively).||Week 24 or Week 48||||participants|||Number
1463025|NCT00758043|Secondary|Proportion of Enrolled Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up||Week 72|||||||
1463026|NCT00758043|Secondary|Proportion of Randomized Subjects Who Relapse, Defined as Those Who Complete Treatment, Have Undetectable HCV RNA at End of Treatment (EOT; Week 24 or Week 48 Respectively), and Become HCV RNA Detectable During Antiviral Follow-up||Week 24 or Week 28|||||||
1463027|NCT00758043|Secondary|Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment|SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.|12 weeks after last dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1463028|NCT00758043|Secondary|Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12|Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).|Week 4 and Week 12|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1463029|NCT00758043|Secondary|Proportion of Subjects Who Have Undetectable HCV RNA at Week 72|SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.|72 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1463030|NCT00758043|Primary|Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)|SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).|24 weeks after the last planned dose of study treatment|The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.|||participants|||Number
1506268|NCT00425269|Primary|Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1463033|NCT00757848|Secondary|Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463034|NCT00757848|Secondary|Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463035|NCT00757848|Secondary|Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463036|NCT00757848|Secondary|Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463037|NCT00757848|Secondary|Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463038|NCT00757848|Secondary|Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463039|NCT00757848|Secondary|Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463040|NCT00757848|Primary|Cystic Fibrosis Questionnaire (CFQ-R) - Quittner|Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||units on a scale||Standard Error|Least Squares Mean
1463041|NCT00757848|Primary|Bronkotest Diary Card Signs and Symptoms|The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||Signs and Symptoms|||Number
1463042|NCT00757848|Primary|Evening Peak Expiratory Flow (PEF)|Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|The last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1463308|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline through 6 weeks|All randomized participants.|||participants|||Number
1463043|NCT00757848|Primary|Morning Peak Expiratory Flow (PEF)|Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment|Last 7 days on treatment|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L/min||Standard Error|Least Squares Mean
1463044|NCT00757848|Primary|Forced Vital Capacity (FVC)|Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1463045|NCT00757848|Primary|Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)|FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1463046|NCT00757848|Primary|Slow Vital Capacity (SVC)|Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1463047|NCT00757848|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||L||Standard Error|Least Squares Mean
1463048|NCT00757848|Primary|24-hour Sputum Weight|Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.|Baseline and day 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||grams||Standard Error|Least Squares Mean
1463049|NCT00757848|Primary|Sputum Percentage Neutrophil Count|Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||percentage of neutrophils in WBCs||Standard Error|Least Squares Mean
1463050|NCT00757848|Primary|Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline|Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits|Baseline and Values from day 21 to 28|The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle.|||ratio||95% Confidence Interval|Least Squares Mean
1463051|NCT00757822|Secondary|Patient Satisfaction 2: Willingness to Pay Extra Money for Post-Operative Nausea and Vomiting (PONV) Preventive Medication|Percent of participants willing to pay extra money for preemptive medication for PONV for subsequent surgical procedures when queried at post-operative 24-48 hr. and at 2-6 wk. follow-up interviews.|Post-operative follow-up interviews 24 hr to 6 weeks post surgery||||percent of participants|||Number
1463052|NCT00757822|Secondary|Patient Satisfaction: Willingness to Take Pre-operative Medication for Post-operative Nausea and/or Vomiting|Percent of participants who responded that they would be willing to take preemptive medication for nausea and vomiting for subsequent surgeries when queried during post-operative follow-up interviews at 24-48 hrs or 2-6 weeks.|Post operative follow up interviews 24 hrs to 6 wks||||percent of participants|||Number
1463053|NCT00757822|Secondary|Post-operative Antiemetic Use|Percentage of participants requiring post-operative anti-emetic medications.. Anti-emetic medication need was assessed during a) post-operative care unit (PACU) stay and b)during the first 48 hrs. following discharge from PACU to home or if applicable to in-patient unit.|End of surgery to 48 hr post surgery||||percentage of participants|||Number
1463054|NCT00757822|Secondary|Post-Surgery Hospital Admissions (All Cause) After Out-patient Abdominal Procedure|Number of all-cause hospital admissions on day of elective out-patient surgery .|Post-operative Day of Surgery (DOS)||||participants|||Number
1463055|NCT00757822|Secondary|Post-Operative Care Unit Length of Stay (Min)|Length of time in PACU (minutes) measured from end of surgery to time of transfer to ambulatory care prior to home discharge or time to hospital admission if applicable.|Day of surgery (time from end of surgery to transfer to ambulatory pre-discharge unit or other unit)||||minutes||Inter-Quartile Range|Median
1463056|NCT00757822|Primary|Post-operative Nausea and Vomiting (PONV) Incidence 24-48 Hours Post Surgery|Participants were queried for presence of postoperative nausea (PON) or postoperative vomiting (POV) during the 24-48 hr window post surgery.|24-48 hrs post surgery||||percentage of participants|||Number
1463057|NCT00757822|Primary|Maximum Reported Post-Operative Nausea Scores on Visual Analog Scale (VAS) Scale|"VAS Scale: 0=no nausea, 1-3=mild nausea, 4-6= moderate nausea, 7-9= severe nausea, 10=extreme nausea usually accompanied with vomiting.~VAS nausea score were obtained every 30 min from entry into post-operative care unit (PACU) for first 2 hrs. and then hourly until time of transfer out of PACU."|Post-operative Care Unit (PACU) stay from end of surgery to transfer to ambulatory unit||||percentage of participants|||Number
1463059|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of CD4 cells||Standard Deviation|Mean
1463060|NCT00757783|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).|Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. LOCF was applied. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||cells/uL||Standard Deviation|Mean
1463061|NCT00757783|Secondary|Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.|Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||cells/micro L||Standard Deviation|Mean
1463062|NCT00757783|Secondary|Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.|the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Log10 HIV RNA||Standard Deviation|Mean
1463063|NCT00757783|Secondary|Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)|Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.|||number of participants|||Number
1463064|NCT00757783|Secondary|Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.|Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.|Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit.|||number of participants|||Number
1463065|NCT00757783|Secondary|Change From Baseline in Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) at Week 12 and 48.|Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.|||HOMA-IR score||Standard Deviation|Mean
1463066|NCT00757783|Secondary|Change From Baseline in Insulin at Week 12 and 48.|Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.|Baseline, Week 12 and 48|The ITT population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group, respectively.|||IU/mL||Standard Deviation|Mean
1463067|NCT00757783|Secondary|Change From Baseline in Glucose at Week 12 and 48.|Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.|Baseline, Week 12 and 48|Intent-to-treat (ITT) population included participants who remained on study through Week 48 and had an assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. ‘N’=participants evaluable for this measure and 'n'=participants evaluable for this outcome measure at specified time points for each group.|||mg/dL||Standard Deviation|Mean
1463068|NCT00757783|Secondary|Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.|Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||ratio||Standard Deviation|Mean
1463069|NCT00757783|Secondary|Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||g/L||Standard Deviation|Mean
1463070|NCT00757783|Secondary|Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||grams per liters (g/L)||Standard Deviation|Mean
1506269|NCT00425269|Primary|The Fasting Plasma Glucose Value, Baseline||baseline||||mmol/L||95% Confidence Interval|Mean
1463071|NCT00757783|Secondary|Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
1463072|NCT00757783|Secondary|Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
1463073|NCT00757783|Secondary|Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48|Observed Values|Baseline, Week 12 and 48|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||mg/dL||Standard Deviation|Mean
1463074|NCT00757783|Primary|Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12|Observed values.|Baseline, Week 12|The LE set consisted of all subjects in the PP analysis set who remained on study through Week 48 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 48 visit. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||milligram per deciliters (mg/dL)||Standard Deviation|Mean
1463075|NCT00757705|Secondary|Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24|The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463076|NCT00757705|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).|Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.|||Participants|||Number
1463077|NCT00757705|Secondary|Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24|The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.|||Units on a scale||Standard Deviation|Mean
1463078|NCT00757705|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants."|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463079|NCT00757705|Secondary|Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24|The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline, Week 24|ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point.|||Units on a scale||Standard Deviation|Mean
1463080|NCT00757705|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463309|NCT00755807|Secondary|Number of Participants Who Discontinued During the Acute Phase (by Week 6)||Baseline through 6 weeks|All randomized participants.|||participants|||Number
1498041|NCT00488059|Primary|Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16||Week II-16|Intent-to-treat population|||participants|||Number
1463081|NCT00757705|Secondary|Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Up to Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure.|||Percentage of participants|||Number
1463082|NCT00757705|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.|Baseline, Week 24|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463083|NCT00757705|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using last observation carried forward (LOCF). Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||Units on a scale||Standard Deviation|Mean
1463084|NCT00757666|Secondary|VO2 at Ventilatory Threshold||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1463085|NCT00757666|Secondary|Exercise Time||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1463086|NCT00757666|Secondary|Metabolic Chronotropic Relationship (MCR) Slope||1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1463087|NCT00757666|Secondary|Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test|This outcome measure will be compared against baseline.|2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1463088|NCT00757666|Primary|Mean Change in Functional Capacity (Peak VO2).|"The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor.~The mean change in functional capactity will be compared against baseline; changes from baseline will be measured."|1 month and 2 months post-implant|Data was not analyzed since patient enrollment was ceased and study was prematurely terminated.||||||
1463089|NCT00757627|Secondary|Change From Baseline in Patient-SF36 (Short Form 36) Domain Scores at Week 4|Weighted scores of the 8 domains of SF36 (i.e., physical functioning; role limiting due to physical problem; bodily pain; general health; vitality; social functioning; role limiting due to emotional problem; mental health) were scored on a scale from 0 ~100, with 100 representing the best possible functioning)|Baseline and Week 4|Intention to treat (ITT)|||Units on a Scale||Standard Deviation|Mean
1463090|NCT00757627|Secondary|Change From Baseline in Number of Days Patient Miss From Work or House Keeping Work at Week 4||Baseline and Week 4|Only patients with both baseline and week 4 data were included in this analysis.|||Days||Standard Deviation|Mean
1463091|NCT00757627|Secondary|Changes From Baseline in Patient TSQM (Treatment Satisfaction Questionnaire for Medication) Domain Scores at Week 4|TSQM consists of four domains (effectiveness; side effect; convenience and overall satisfaction), domain scores ranged from 0 (0=worst) to 100 (100=best) were derived from converting the original Likert's scales to VAS scale.|Baseline and Week 4|"22 patients who reported side effects at baseline and week 4 were included in side effect evaluation."|||Units on a Scale||Standard Deviation|Mean
1463092|NCT00757627|Secondary|Change From Baseline of Patient BPI (Brief Pain Inventory) Scores at Week 4|BPI consists of pain and pain interference domains. For pain (0=no pain to 10=extreme pain); for pain interference ( 0=no interference to 10= greatest interference).|Baseline and Week 4|Only patients with both baseline and week 4 follow up data were included in this analysis.|||Units on a Scale||Standard Deviation|Mean
1463093|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Week 4|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [ Not present, moderate and extreme]for discomfort and anxiety/depression|Week 4|per protocol|||Percentage of participants|||Number
1463121|NCT00757484|Secondary|Percentage of Participants Undergoing Different Types of Anesthesia|Patients were given either general, regional or local-modified anesthesia care (LO-MAC). Some of the patients ended up getting both general and regional anesthesia (sometimes anesthesia team decides to add regional for postop pain control).|January 2007 to January 2008||||percentage of participants|||Number
1463122|NCT00757484|Secondary|Percentage of Women With Asymptomatic Hypotension|% women with asymptomatic hypotension|1 year||||percentage of participants|||Number
1463094|NCT00757627|Secondary|Patient Assessment of General Health Outcome by EuroQoL-5 Dimensions (EQ-5D) at Baseline|The percentage of participants who met the criteria of any of the 3 categories of EQ-5D at baseline and at week 4 were collected.The EQ-5D comprises of 5 dimensions (mobility, self-care, usual activities, pain / discomfort, and anxiety / depression) to be answered using a 3-categorical Likert's scales of: [No problem, Some problem, and Not able to carry out] for mobility, self-care and usual activities and [Not present, moderate and extreme] for discomfort and anxiety/depression.|Baseline|"Only patients with baseline and week 4 data were included in the analysis.~Week 4 N Values; Motility 423 , Self care 422 , Daily Activity 421 , Pain/Discomfort 421 , Anxiety/Depressed 422"|||Percentage of Participants|||Number
1463095|NCT00757627|Primary|"The Percentage of Participants Achieving ≥30% Decrease From Baseline in Pain Intensity as Measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Question 1 Pain Walking on a Flat Surface at Week 4"|"WOMAC for pain assessment by patient (0-100 mm Visual Analog Scale (VAS) with 0 represent no pain and 100 represent extreme pain)"|Baseline and end of week 4|"Per protocol (all patients who completed the WOMACpain walking on a flat surface  question at baseline and follow up visit at week 4 will be included for analysis of this endpoint.~Among the 419 patients with follow up visit data, 27 patients rated 0 in their VAS pain score at baseline and were excluded from this analysis."|||Percentage of Participants|||Number
1463096|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Week 4 Using IGART|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants met the criteria of any of the 5 categories at week 4 were collected.|Week 4|Per Protocol|||Percentage of Participants|||Number
1463097|NCT00757627|Secondary|Physicians' Global Assessment of Patients' Response to Therapy at Baseline Using IGART (Investigator Global Assessment of Response to Therapy)|The IGART comprised of five categories: No response, poor response, fair response, good response, and excellent response. The percentage of participants who met the criteria of any of the 5 categories at baseline were collected.|Baseline|Only patients with baseline and week 4 data were included.|||Percentage of Participants|||Number
1463098|NCT00757627|Secondary|Mean Change From Baseline in Patient WOMAC Domain Scores at Week 4|The change from baseline in 3 domain scores (pain, stiffness, and difficult in doing daily activity) of WOMAC at week 4 were measured. Each domain comprises of questions and VAS scales for scoring. For pain domain, 0 represents no pain and 100 represents extreme pain; for stiffness domain, 0 represents no stiffness and 100 represents extreme stiffness; for difficult in doing daily activity domain, 0 represents no difficulty and 100 represents most difficulty.|Baseline and Week 4|Only patients with baseline and week 4 data were included in this analysis of change|||Units on a Scale||Standard Deviation|Mean
1463099|NCT00757601|Secondary|Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006|The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM.hr||Standard Deviation|Mean
1463100|NCT00757601|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.|||participants|||Number
1463101|NCT00757601|Secondary|Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose|The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||hr||Standard Deviation|Mean
1463102|NCT00757601|Secondary|Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||hr||Full Range|Median
1463103|NCT00757601|Secondary|Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose||From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM||Standard Deviation|Mean
1463104|NCT00757601|Secondary|Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006|The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|From pre-dose to 168 hours post-dose|Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.|||nM.hr||Standard Deviation|Mean
1463123|NCT00757484|Primary|Percentage of Participants Who Underwent Gynecologic Surgery|491 women were included in analysis. Measure is categorized by the type of surgery.|January 2007 to January 2008|491 women were included in analysis.|||percentage of participants|||Number
1463655|NCT00753675|Secondary|Disease Control Rate (CR+PR+SD)|DCR is the sum of patients with a best overall CR, PR or SD (>=8 weeks) by the patient in the analysis|up to 1032 days|ITT|||Partecipants|||Number
1463105|NCT00757601|Primary|Number of Participants Experiencing Adverse Events (AEs) On Study|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.|From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)|All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.|||participants|||Number
1463106|NCT00757588|Other Pre-specified|Percentage of Participants With Reported and Confirmed Hypoglycemia|Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/|Baseline to Week 52||||Percentage of Participants|||Number
1463107|NCT00757588|Other Pre-specified|Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period|"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4."|Baseline and during and up to 14 days after last dose of study drug (in Week 52)|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1463108|NCT00757588|Other Pre-specified|Shift in Platelet Counts From Baseline to Selected Visits (LOCF)|Platelet count=value*10^9 c/L|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1463109|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Heart Rate||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.|||Beats per minute||95% Confidence Interval|Number
1463110|NCT00757588|Other Pre-specified|Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings||Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52|All participants who received at least 1 dose of double-blind study medication.|||mm Hg||95% Confidence Interval|Number
1463111|NCT00757588|Other Pre-specified|Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.|Baseline to Week 52, continuously|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1463112|NCT00757588|Other Pre-specified|Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)|Absolute lymphocyte count=value*10^3 c/uL|Baseline and Weeks 24 and 52|All participants who received at least 1 dose of double-blind study medication.|||Participants|||Number
1463113|NCT00757588|Other Pre-specified|Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results|"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions."|Baseline to Week 52|Participants who had normal ECG findings at baseline and who received at least 1 dose of study medication.|||Participants|||Number
1463114|NCT00757588|Secondary|Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)|Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.|||Units||Standard Error|Mean
1463115|NCT00757588|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response|Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value.|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24-week period.|||Percentage of participants|||Number
1463116|NCT00757588|Secondary|Change From Baseline in Fasting Plasma Glucose Values||Baseline to Week 24||||mg/dL||Standard Error|Mean
1463117|NCT00757588|Secondary|Change From Baseline in 120-minute PPG Values During an MTT|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal.|Baseline to Week 24||||mg/dL||Standard Error|Mean
1463118|NCT00757588|Secondary|Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)|An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal|Baseline to Week 24||||mg*min/dL||Standard Error|Mean
1463119|NCT00757588|Primary|Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])|Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use|Baseline to Week 24|Randomized participants who received at least 1 dose of double-blind study medication. Participants must also have had both a baseline and at least 1 postrandomization measurement in the 24- and 52-week periods.|||Percentage of change||Standard Error|Mean
1463120|NCT00757484|Secondary|Surgical Time|Length of surgery|January 2007 to January 2008||||minutes||Full Range|Mean
1463124|NCT00757237|Other Pre-specified|Time to Need for Inhaled and/or IV Antipseudomonal Antibiotics for Respiratory Event (Other Than Randomized Treatment)|"Antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee.~Use of IV and/or inhaled antibiotics for a respiratory event was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to antibiotic use for a respiratory event was measured in days from baseline (Day 0) to the date of first antibiotic use for a respiratory event or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
1463125|NCT00757237|Other Pre-specified|Number of Respiratory Events Requiring IV and/or Inhaled Antipseudomonal Antibiotics (Other Than Randomized Treatment)|Inhaled and/or IV antipseudomonal antibiotic use for respiratory event was determined through event adjudication by a sponsor-independent, blinded review committee. Use of IV and/or inhaled antipseudomonal antibiotics was compiled from data recorded on the concomitant medications eCRF and compared to reported AEs to determine use for a respiratory event. The time to IV and/or inhaled antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored.|Day 0 through Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||events|||Number
1463126|NCT00757237|Other Pre-specified|Total Number of Respiratory Hospitalizations|Respiratory hospitalizations were determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed hospitalizations and determined which were related to respiratory events.|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||hospitalizations|||Number
1463127|NCT00757237|Other Pre-specified|Treatment Satisfaction Questionnaire for Medication (TSQM) - Global Satisfaction Results at Week 20|This 14 item questionnaire consists of 3 subscales that gauge participant perceptions of a medication’s effectiveness, side effects, and convenience. The measure also contains a global satisfaction scale to evaluate overall participant satisfaction. The global satisfaction score is the endpoint reported here. The range of scores is 0 to 100, with higher scores indicating greater satisfaction.|At Week 20|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||units on a scale||Standard Error|Least Squares Mean
1463128|NCT00757237|Other Pre-specified|Mean Actual Change From Baseline in CFQ-R RSS Score Across 3 Treatment Courses|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was the average actual change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms) at the end of each treatment course (Weeks 4, 12, and 20).|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The LOCF method was used to impute missing data for statistical purposes.|||units on a scale||Standard Error|Least Squares Mean
1463129|NCT00757237|Other Pre-specified|Actual Change From Baseline in CF Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome tool measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). LOCF method was used to impute missing data for statistical analyses.|||Units on a scale||Standard Error|Least Squares Mean
1463130|NCT00757237|Secondary|Time to First Respiratory Hospitalization|"This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events.~Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF.~Time to first respiratory hospitalization was the number of days from baseline (Visit 2) to the date of first respiratory hospitalization or the date of study completion (last visit) /or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
1463131|NCT00757237|Secondary|Time to Need for Intravenous (IV) Antipseudomonal Antibiotics for Respiratory Events|"IV antipseudomonal antibiotic use for a respiratory event was determined through the adjudication of events by a sponsor-independent, blinded review committee.~Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored."|Day 0 to Day 168 (end of study)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||days||95% Confidence Interval|Median
1463132|NCT00757237|Secondary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by MMRM analysis using the population of participants with prior inhaled tobramycin use of >=84 days in the previous 12 months."|Baseline and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on participants with prior inhaled tobramycin use >= 84 days in the previous 12 months using the ITT analysis set.|||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
1463133|NCT00757237|Secondary|Relative Change From Baseline in FEV1 Percent Predicted at Day 28 in Subjects Who Received Inhaled Tobramycin for >= 84 Days in the 12 Months Prior to Randomization|Spirometry was performed according to ATS guidelines. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an ANCOVA model-based method, using the population of participants with prior inhaled tobramycin use of >= 84 days in the previous 12 months.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on participants with previous inhaled tobramycin use of >= 84 days within the previous 12 months using the ITT analysis set. The last observation carried forward (LOCF) method was used to impute missing data for statistical analyses.|||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
1463134|NCT00757237|Primary|Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses|"Spirometry was performed according to ATS guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height.~Treatment effect on the average adjusted means for the actual change in FEV1 percent predicted at Visits 4, 6, and 8 (Weeks 4, 12, and 20) was tested by mixed-effect model repeated measures (MMRM) analysis using the ITT population analysis set."|Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug).|||actual change in FEV1 percent predicted||Standard Error|Least Squares Mean
1463135|NCT00757237|Primary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. FEV1 percent predicted is a normalized value of FEV1 calculated using the Knudson equation and based upon participant age, gender, and height. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested using an analysis of covariance (ANCOVA) model-based method.|Baseline and end of treatment Course 1 (Day 28)|Analysis was based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). The last observation carried forward (LOCF) method was used to impute missing data.|||percent change in FEV1 percent predicted||Standard Error|Least Squares Mean
1463136|NCT00757172|Secondary|Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution|Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.|Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery|All recruited participants.|||participants|||Number
1463137|NCT00757172|Secondary|Percentage of Participants With 2-year Disease-free Survival|Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.|2 years|All registered participants who have met the eligibility criteria.|||percentage of participants|||Number
1463138|NCT00757172|Secondary|Percentage of Participants With 3-year Overall Survival|Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).|3 years|All registered participants who have met the eligibility criteria.|||percentage of participants|||Number
1463139|NCT00757172|Secondary|Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)||Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.|||participants|||Number
1463140|NCT00757172|Primary|Number of Participants With Pathologic Complete Response Following Surgery|Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.|Post surgery|All participants who have met the eligibility criteria that have signed a consent form and began treatment.|||participants|||Number
1463141|NCT00757003|Secondary|Overall Survival|Overall survival is reported as the count of participants alive 60 months following implant procedure.|60 months|9 lost to followup, 4 withdrew, 2 explanted, 1 never implanted, all excluded|||Participants|||Count of Participants
1463142|NCT00757003|Secondary|Count of Participants Experiencing at Least One Endoleak Following Procedure|Endoleak is persistent blood flow in the aneurysm sac.|Up to 60 months following procedure||||Participants|||Count of Participants
1463143|NCT00757003|Primary|Percentage of Participants With Technically Successful Implant|The percentage of participants with technically successful implantation as assessed by the investigator is reported.|Day 0 to Day 30||||percentage of participants|||Number
1463144|NCT00756977|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days||||mOsm/kg||Standard Deviation|Mean
1463145|NCT00756977|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days||||MILL/MCL||Standard Deviation|Mean
1463146|NCT00756977|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
1463147|NCT00756977|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days|Intent to treat population|||1000/MCL||Standard Deviation|Mean
1463148|NCT00756977|Secondary|Serum Chemistry Results (GFR)|Change from Baseline|2 days||||ml/min||Standard Deviation|Mean
1463149|NCT00756977|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||g/dL||Standard Deviation|Mean
1463150|NCT00756977|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||mEq/L||Standard Deviation|Mean
1463151|NCT00756977|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days|Intent-to-treat population: all patients that took any portion of the study preparation.|||U/L||Standard Deviation|Mean
1463152|NCT00756977|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population|||standard %||Standard Deviation|Mean
1463155|NCT00756964|Primary|Number of Patients With Acute Kidney Injury (AKI).|Acute kidney injury will be defined as an increase in serum creatinine of 0.3mg/dL from baseline or a 50% increase in serum creatinine from baseline values within 48 hours after surgery.|Within 48 hours postoperatively|As no similar study has been performed, a power analysis could not be performed. As such, we decided to do a pilot study with 26 subjects and to set criteria to maximize the likelihood of seeing an effect.|||Participants|||Number
1463156|NCT00756938|Primary|Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.|||Participants|||Number
1463157|NCT00756938|Primary|Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)||up to 12 weeks (Base Study); up to 24 months (Extension)|All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.|||Participants|||Number
1463158|NCT00756938|Secondary|Mean Change From Baseline in Diastolic Blood Pressure|Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation|||mmHg||Standard Deviation|Mean
1463159|NCT00756938|Primary|Mean Change From Baseline in Systolic Blood Pressure|Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.|Baseline and Day 21|Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation|||mmHg||Standard Deviation|Mean
1463160|NCT00756886|Primary|Atrial Fibrillation||0-21 days post-operative||||participants|||Number
1463161|NCT00756730|Primary|The Change in Fasting Triglyceride Level From Baseline to Week 24||Baseline to week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
1463162|NCT00756730|Primary|At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||percentage of participants|||Number
1463163|NCT00756730|Secondary|HDL Cholesterol at Week 24||24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
1463164|NCT00756730|Secondary|LDL Cholesterol at Week 24||week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
1463165|NCT00756730|Secondary|Total Cholesterol in the Two Study Groups at 24 Weeks||Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||mg/dL||Full Range|Mean
1463166|NCT00756730|Secondary|Difference in CD4 From Baseline to Week 24||baseline to Week 24|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.|||cells/mm^3||Standard Error|Mean
1463167|NCT00756730|Secondary|Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24||Week 4, 12 & 24||||percentage of participants|||Number
1463168|NCT00756730|Primary|Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.|A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.|baseline, 24 weeks|Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.|||percentage of patients|||Number
1463169|NCT00756678|Secondary|Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16|Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.|Day 16|Intent to Treat; defined as all randomized (started study) patients.|||Number of patients|||Number
1463170|NCT00756678|Secondary|Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16|"Percentage of patients who responded Strongly Agree and Agree to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are Strongly Agree, Agree, Neither Agree or Disagree, Disagree and Strongly Disagree."|Day 16|Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure|||Percentage of Patients|||Number
1463171|NCT00756678|Secondary|Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16|Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.|Baseline, Day 16|Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
1463172|NCT00756678|Primary|Mean Frequency of Eye Drop Use Over 1 Week|Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.|1 week|Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure|||Use per day||Standard Deviation|Mean
1463173|NCT00756574|Secondary|Absenteeism|Absent from work because of flu-like illness|over study period||||participants|||Number
1463174|NCT00756574|Secondary|Influenza-like Illness|Cough and fever|Over entire study period||||participants|||Number
1463175|NCT00756574|Secondary|Physician Visits for Respiratory Illness|visit to primary care MD|one year||||participants|||Number
1463176|NCT00756574|Primary|Laboratory-confirmed Influenza Infection|Laboratory confirmed influenza|one year||||participants|||Number
1463177|NCT00756561|Primary|Intratesticular Hormones in Normal Men|Average between right and left testis for each subject and serum hormone concentration in 10 normal men|6-weeks|per protocol|||ng/mL||Inter-Quartile Range|Median
1463178|NCT00756548|Secondary|Serum Chemistry Results (Osmolality)|Change from Baseline|2 days||||mOsm/kg||Standard Deviation|Mean
1463179|NCT00756548|Secondary|Hematology Results - Red Blood Cells|Change from Baseline|2 days||||million/microliter||Standard Deviation|Mean
1463180|NCT00756548|Secondary|Hematology Results (1000/MCL)|Change from Baseline|2 days||||1000/MCL||Standard Deviation|Mean
1463181|NCT00756548|Secondary|Hematology Results - Hemoglobin|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
1463182|NCT00756548|Secondary|Serum Chemistry Results - Glomerular Filtration Rate|Change from Baseline|2 days||||ml/min||Standard Deviation|Mean
1463183|NCT00756548|Secondary|Serum Chemistry Results (g/dL)|Change from Baseline|2 days||||g/dL||Standard Deviation|Mean
1463184|NCT00756548|Secondary|Serum Chemistry Results (mg/dL)|Change from Baseline|2 days||||mg/dL||Standard Deviation|Mean
1463185|NCT00756548|Secondary|Serum Chemistry Results (U/L)|Change from Baseline|2 days||||U/L||Standard Deviation|Mean
1463186|NCT00756548|Secondary|Hematology Results (%)|Change from Baseline|2 days|Intent to treat population|||Percentage of cells||Standard Deviation|Mean
1463187|NCT00756548|Secondary|Serum Chemistry Results (mEq/L)|Change from Baseline|2 days||||milliequivalent/L||Standard Deviation|Mean
1463188|NCT00756548|Primary|Efficacy - Preparation Quality Using a 4 Point Scale|"Percentage of patients with a successful preparation (cleaning rated as Good or Excellent)"|2 days|186 patients were included in the BLI850 intent-to-treat population. One patient took the preparation but did not undergo colonoscopy due to insurance coverage issues. This patient is excluded from all efficacy analyses.|||percentage of participants||95% Confidence Interval|Number
1463189|NCT00756470|Primary|Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy|Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.|Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks)|With an intent-to-treat population analysis, all participants who received any treatment were included in the analyses.|||Percentage of Participants|||Number
1463190|NCT00756470|Secondary|Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)|Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.|Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks)|While analyses was based on intent-to-treat (ITT) the surgical population includes only subjects who underwent definitive surgery (10 participants had a modified radical mastectomy) thus 5 were not evaluable for this outcome.|||participants|||Number
1463191|NCT00756457|Secondary|Foot Strength|A force transducer (Model SML-200, Interface, Scottsdale, AZ) was connected in series with a resistance plate and oscilloscope (TDS 410A, Tektronix, Beaverton, OR) to display force readings. Participants were seated with their leg in an an air stirrup brace (Aircast, Inc.) mounted on uprights. The air stirrup brace was adjusted so the heel was approximately 10 cm above the resistance plate, resulting in 30 to 45 degrees of ankle plantar flexion depending on foot length. The resistance plate was mounted on ball bearing tracks in the medial/lateral direction and moleskin was used to fit to the general shape of the medial forefoot. The result was that participants could exert maximum effort against the resistance plate (medial direction) with little discomfort. This testing position essentially replicates the manual muscle test position for the posterior tibialis muscle. Force in Newtons was then divided by body mass in kilograms to calculate normalized strength (N/Kg).|Measured at Weeks 1, 6, and 12||||N/kg||Standard Deviation|Mean
1463212|NCT00756236|Primary|Area Under the Curve of etSEV Over the First Hour|We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.|Every 5 minutes for 2 hours||||percent*hour||Standard Deviation|Mean
1463213|NCT00756093|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable.|once upon instillation||||units on a scale||Standard Deviation|Mean
1463519|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463192|NCT00756457|Primary|Short Musculoskeletal Functional Assessment|The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is a 46 item self-report questionnaire consisting of the Dysfunction Index, which has thirty-four items, and the Bother index which has 12 items. The Dysfunction index is used for assessment of patient perceptions of functional performance while the Bother index is used to assess patients’ perceptions of the degree patients are bothered in broad areas such as recreation and leisure. The responsiveness to change of the SMFA is 10 points out a range of 100 for each scale (Dysfunction, Mobility, and Bother indexes). The SMFA is also particularly suitable for the current investigation due to the presence of a sub-category of questions from the Dysfunction Index that pertains specifically to mobility (i.e. Mobility Index). Lower scores (lowest = 0) indicate better function, mobility, and that patients are less bothered while higher scores (highest = 100) indicate worse function, mobility and that patients are bothered.|Measured at Weeks 1, 6, and 12||||score||Standard Deviation|Mean
1463193|NCT00756457|Secondary|Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)|A 3 dimensional foot kinematic model including the tibia, calcaneus (hindfoot), 1st metatarsal, 2-4th metatarsals and hallux was used to measure foot movement. Six infrared cameras (Optotrak Motion Analysis System, Northern Digital Inc, CAN), synchronized with force plate data (Model 9286, Kistler, Switzerland), were used to collect kinematics (60 Hz) and force (1000 Hz) data with the Motion Monitor software Version 7.24 (Motion Monitor, Innsport Training Inc, USA). Anatomically based coordinate systems were established for each segment using digitized boney landmarks consistent with a previous study. Kinematic data were smoothed using a 4th order, zero phase lag, Butterworth filter with a cut off frequency of 6 Hz. To calculate relative joint angles a Cardan angle Z-X-Y sequence of rotations was used as suggested by Cole et al. The range of possible values varies for each individual and each joint.|Measured at Weeks 1,6 and 12||||Degrees||Standard Deviation|Mean
1463194|NCT00756457|Primary|Foot Function Index(FFI)|The Foot Function Index (FFI) is a validated disease specific questionnaire that has been used to document outcomes in uncontrolled studies of PTTD. The domains of the 23 item FFI questionnaire include pain, disability, and activity limitations. The scale was originally validated in subjects with foot problems related to rheumatoid arthritis patients, and has subsequently been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD. In clinical trials, the FFI has been used to detect change attributable to orthotics, plantar fasciitis, and brace use in PTTD. The three domains of the FFI include pain (FFI-Pain) range 0 to 90, disability (FFI-Disability) range 0- 90, and activity limitations (FFI-Activity Limitations) range 0 to 50. Each category asks patients to rate items relative to pain with higher scores indicating greater pain. The average of the three scales is the FFI-Total.|Measured at Weeks 1, 6, and 12|A power analysis was performed based on previous a previous study. Only the participants that completed the study are included in the analysis. One participant opted to have surgery at 2 weeks from the Brace & Exercise group. One participant moved overseas and the other resumed cancer treatments bringing the total to 17.|||units on a scale||Standard Deviation|Mean
1463195|NCT00756444|Primary|Steady-state Plasma Concentrations (Css) for 5-FU With and Without the Presence of Panitumumab|Steady-state plasma concentrations (Css) of 5-FU were estimated as the mean of two or more evaluable concentrations at 24, 72, and 96 hours after the start of 5-FU infusion. Css is estimated both for subjects receiving 5-FU with panitumumab and for subjects receiving 5-FU without panitumumab|24 to 96 hours following start of cycle 2 infusion with 5-FU|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive Css|||ng/mL||Standard Deviation|Mean
1463196|NCT00756444|Primary|Area Under the Curve (AUC) of Total Plasma Cisplatin-derived Platinum Levels With and Without the Presence of Panitumumab|AUC refers to area under the concentration curve from time 0 to last measurable concentration. AUC of total plasma cisplatin-derived platinum levels is estimated both for subjects receiving cisplatin with panitumumab and for subjects receiving cisplatin without panitumumab.|Levels measured at 0.5, 1, 2, 3, 4, 6 and 24 hours following start of cycle 2 cisplatin infusion|Subjects who receive at least 2 cycles of assigned treatment and who have sufficient plasma collection to derive AUC|||ng*hr/mL||Standard Deviation|Mean
1463197|NCT00756314|Secondary|Satisfaction With the Used Contraceptive Method|the satisfaction was measured according a scale ranging in 3 levels: very satisfied, somewhat satisfied and dissastisfied.|During the 6-month Follow-up||||participants|||Number
1463198|NCT00756314|Primary|Chosen Contraceptive Method After Counseling|the type of contraceptive methods chosen by women following after counseling|after the contraceptive counseling||||participants|||Number
1463199|NCT00756314|Secondary|Pregnancies Among All Women||within the first six months after intervention||||participants|||Number
1463200|NCT00756314|Primary|Correct Use of the Method|the correct use was considerer by each methods according the prescription.|within the first 6 months after intervention||||participants|||Number
1463201|NCT00756314|Primary|Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up|"The acceptability and the use of contraceptives during the follow-up period was defined as just yes or no"|after the contraceptive counseling and during the 6-month follow|"The analysis was by intention to treat in both groups. All the women were retained in their original assigned group."|||participants|Participants||Number
1463202|NCT00756275|Secondary|Beck Depression Inventory|0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression|Week 12|Outcome data available for 80 participants who had valid depression data 12 week assessment.|||units on a scale||Standard Deviation|Mean
1463203|NCT00756275|Secondary|Percent Relapsed to Any Heavy Drinking|6 or more drinks for men; 5 or more drinks for women|6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of particpiants|||Number
1463204|NCT00756275|Secondary|Percent Relapsed to Any Heavy Drinking|6 or more drinks for men; 5 or more drinks for women|3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of participants|||Number
1463205|NCT00756275|Secondary|Percent Relapsed to Drug Use||6 month follow up|Outcome data available for 80 participants who completed 6 month follow up.|||percentage of participants|||Number
1463206|NCT00756275|Secondary|Percent Relapsed to Drug Use||3 month follow up|Outcome data available for 89 participants who completed 3 month follow up.|||percentage of participants|||Number
1463214|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 5).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463215|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 4).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463216|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Week 2).|The Subjective Number of Awakenings weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463217|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
1463218|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
1463219|NCT00756002|Secondary|Subjective Number of Awakenings, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Number of Awakenings (the subjective measure of how many times the subject believes they awoke during the night) obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. The average of two nights' data is used for each subject at a visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||Number of awakenings per night||Standard Error|Least Squares Mean
1463220|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 29-30).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
1463221|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 15-16).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
1463222|NCT00756002|Secondary|Number of Awakenings After Persistent Sleep, Per Polysomnography (Nights 1-2).|Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||awakenings after persistent sleep||Standard Error|Least Squares Mean
1463223|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 5).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463224|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 4).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463225|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Week 2).|The Subjective Wake Time After Sleep Onset weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463226|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 29-30).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463227|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 15-16).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463228|NCT00756002|Secondary|Subjective Wake Time After Sleep Onset, Per Post-sleep Questionnaire (Nights 1-2).|Subjective Wake Time After Sleep Onset obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463229|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 29-30).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463230|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 15-16).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463231|NCT00756002|Secondary|Wake Time After Sleep Onset, Per Polysomnography (Nights 1-2).|The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463232|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 5).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463233|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 4).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463234|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Week 2).|The subjective sleep quality weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463235|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 29-30).|Sleep quality obtained from the Post-Sleep Questionnaireperformed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463236|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 15-16).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463237|NCT00756002|Secondary|Subjective Sleep Quality, Per Post-sleep Questionnaire (Nights 1-2).|Sleep quality obtained from the Post-Sleep Questionnaire performed in the sleep lab the morning following overnight Polysomnography. 7=Extremely Poor; 6=Very Poor; 5=Poor; 4=Fair; 3=Good; 2=Very Good; 1=Excellent.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||scores on a scale||Standard Error|Least Squares Mean
1463238|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 29-30).|The Total Sleep Time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
1463239|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 15-16).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
1463240|NCT00756002|Secondary|Sleep Efficiency, Per Polysomnography (Nights 1-2).|The total sleep time was divided by the total time in bed (ie, the number of minutes from the beginning of the Polysomnography recording to the end of the recording), multiplied by 100.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||percentage of time asleep to time in bed||Standard Error|Least Squares Mean
1463241|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 5).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463242|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 4).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463243|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Week 2).|Subjects answered a Post-Sleep Questionnaire via IVRS. The Subjective Total Sleep Time weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463244|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 29-30).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 29 -30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463245|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 15-16).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463246|NCT00756002|Secondary|Subjective Total Sleep Time, Per Post-sleep Questionnaire (Nights 1-2).|Subjects answered a Post-Sleep Questionnaire in the sleep lab the morning following overnight Polysomnography. Subjective Total Sleep Time measured the average of the 2 mornings after each overnight Polysomnography Visit.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463247|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 29-30).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463248|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 15-16).|All of the minutes of Stages 1, 2, 3/4 NREM and REM sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463249|NCT00756002|Secondary|Total Sleep Time, Per Polysomnography (Nights 1-2).|All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463250|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 5|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463251|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 4|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463252|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2).|Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural “home” setting.|Week 2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463253|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463254|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463255|NCT00756002|Secondary|Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2).|Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab.|Nights 1-2|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463256|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 29-30|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463257|NCT00756002|Secondary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured.|Nights 15-16|The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data.|||minutes||Standard Error|Least Squares Mean
1463258|NCT00756002|Primary|Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2).|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.|Nights 1-2|The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data.|||minutes||Standard Error|Least Squares Mean
1463259|NCT00755937|Secondary|Number of Serious Adverse Events||Throughout study (up to 36 months)|Safety data were collected for all patients registered. Total number of subjects: 556. Non serious adverse events: 198. Serious Adverse Events: 105.|||Number of Serious Adverse Events|||Number
1463260|NCT00755937|Primary|Clinical Remission at 36 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1463290|NCT00755807|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase|Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.|Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.|||participants|||Number
1463261|NCT00755937|Primary|Clinical Remission at 24 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1463262|NCT00755937|Primary|Clinical Remission at 12 Months (CDAI <= 150 Points).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1463263|NCT00755937|Primary|Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|36 months after baseline|Patients at 36 months: Patients with at least 36 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1463264|NCT00755937|Primary|Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|24 months after baseline|Patients at 24 months: Patients with at least 24 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1463265|NCT00755937|Primary|Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).|CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.|12 months after baseline|Patients at 12 months: Patients with at least 12 months of follow-up. Imputation for missing values used either the last observation carried forward or last observation carried backward, whichever had the highest CDAI.|||Participants|||Number
1463266|NCT00755911|Secondary|Number of Participants Who Successfully Received Dental Implant Fixtures|The secondary objective is to determine if Tissue Repair Cell therapy regenerates bone enabling the installation and stability of dental implant fixtures|12 months after tooth extraction||||participants|||Number
1463267|NCT00755911|Primary|Bone Regeneration|"The primary objective of this study is to determine whether the placement of Tissue Repair Cells (TRCs) at the time of tooth extraction can safely and effectively promote bone regeneration in alveolar bone defects created by tooth extraction.~Safety was assessed through adverse event reporting~Bone regeneration was assessed through measures of bone mineral density and bone volume fraction of biopsied regenerated bone tissue. Bone regeneration was also measured through radiographic analysis of relative bone height gain (% of the bone height regenerated relative to the height before tooth extraction)"|12 months after tooth extraction||||% bone height||Standard Deviation|Mean
1463268|NCT00755846|Secondary|Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).|The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.|85 Days.|"Randomized participants who received at least 1 dose of study drug (Intent to Treat), and who had at least 1 fasting plasma glucose measurement after baseline.~Note: Mean percent incidence of marked hyperglycemia was only summarized by treatment group using descriptive statistics."|||percent incidence||Standard Deviation|Mean
1463269|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 85).|The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463270|NCT00755846|Secondary|Change From Baseline in Triglycerides (Day 43).|The change between triglycerides collected at day 43 and triglycerides collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463271|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).|The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463272|NCT00755846|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).|The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463562|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463273|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).|The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463274|NCT00755846|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).|The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463275|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 85).|The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463276|NCT00755846|Secondary|Change From Baseline in Total Cholesterol (Day 43).|The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463277|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 85).|The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463278|NCT00755846|Secondary|Change From Baseline in Fasting Fructosamine (Day 43).|The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463279|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 85).|The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463280|NCT00755846|Secondary|Change From Baseline in Fasting Plasma Glucose (Day 43).|The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.|Baseline and Day 43|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||mg/dL||Standard Error|Least Squares Mean
1463281|NCT00755846|Secondary|Change From Baseline in Glycosylated Hemoglobin at Day 43.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 43 and glycosylated hemoglobin collected at baseline.|Baseline and Day 43.|Randomized subjects who received at least 1 dose of study drug (Intent to treat), and who had measurements at baseline and at Day 43. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1463282|NCT00755846|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Day 85.|Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1463283|NCT00755807|Secondary|Change From Baseline in Weight at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||kilograms (kg)||Standard Deviation|Mean
1463284|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||beats per minute (bpm)||Standard Deviation|Mean
1463285|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||mm Hg||Standard Deviation|Mean
1463286|NCT00755807|Other Pre-specified|Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||gram/deciliter (g/dL)||Standard Deviation|Mean
1463287|NCT00755807|Other Pre-specified|Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||milliEq/Liter||Standard Deviation|Mean
1463288|NCT00755807|Other Pre-specified|Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)||Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||Thousand/microliter||Standard Deviation|Mean
1463289|NCT00755807|Secondary|Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase||Baseline (6 weeks) through Endpoint (18 weeks)|All randomized participants in the open-label extension phase.|||participants|||Number
1467676|NCT00723554|Primary|Heart Rate - Iloprost PD-6 (Period 1)|Heart rate was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population|||beats per minute||Standard Deviation|Mean
1463292|NCT00755807|Secondary|Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1463293|NCT00755807|Secondary|Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.|Baseline (6 weeks) through Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Error|Least Squares Mean
1463294|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|18 weeks|All randomized participants who entered the extension phase.|||participants|||Number
1463295|NCT00755807|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1463296|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline (6 weeks), Endpoint (18 weeks)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1463297|NCT00755807|Secondary|Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline (end of acute phase/Week 6), Endpoint (Week 18)|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1463298|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).|18 weeks|Number of randomized participants who entered and had at least 1 non-missing value during extension phase.|||units on a scale||Standard Deviation|Mean
1463299|NCT00755807|Secondary|Change From Baseline in Weight at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||kilograms (kg)||Standard Error|Least Squares Mean
1463300|NCT00755807|Secondary|Change From Baseline in Pulse Rate at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1463301|NCT00755807|Secondary|Change From Baseline in Blood Pressure at Week 6 (Acute Phase)||Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mm Hg||Standard Error|Least Squares Mean
1463302|NCT00755807|Other Pre-specified|Change From Baseline in Uric Acid at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of uric acid.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mg/dL||Standard Deviation|Mean
1463303|NCT00755807|Other Pre-specified|Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||mg/dL||Standard Deviation|Mean
1463304|NCT00755807|Other Pre-specified|Change From Baseline in the Platelet Count at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of platelet count.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||Thousand/microliter||Standard Deviation|Mean
1463305|NCT00755807|Other Pre-specified|Change From Baseline in Creatinine at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment of creatinine.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
1463306|NCT00755807|Other Pre-specified|Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)|Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||milliEq/Liter||Standard Deviation|Mean
1506270|NCT00425113|Secondary|Time to Sputum Culture Conversion to Negative on Solid Medium||2 months||||days||95% Confidence Interval|Median
1463310|NCT00755807|Secondary|Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)|The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Deviation|Mean
1463311|NCT00755807|Secondary|Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)|Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1463312|NCT00755807|Secondary|Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6|"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a “yes” answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide."|6 weeks|All randomized participants.|||participants|||Number
1463313|NCT00755807|Secondary|Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)|A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1463314|NCT00755807|Secondary|Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1463315|NCT00755807|Secondary|Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)|Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1463316|NCT00755807|Secondary|Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks|A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.|6 weeks|Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented.|||units on a scale||Standard Error|Least Squares Mean
1463317|NCT00755807|Secondary|Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)|This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation.|||participants|||Number
1463318|NCT00755807|Primary|Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)|24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.|Baseline, 6 weeks|Number of randomized participants with baseline and at least 1 post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
1463319|NCT00755755|Primary|Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)|Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.|Week 13|Intent-to-treat|||percentage of change||Full Range|Median
1463518|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463320|NCT00755755|Primary|Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|Week 13 visit|Intent-to-treat|||percentage of patients|||Number
1463321|NCT00755716|Secondary|MNWS|"Minnesota Nicotine Withdrawing Scale~Scale contains 9 items which are scored 0-4. The total range for the scale is 0-36, where higher scores indicate greater nicotine withdrawal symptoms."|Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.|Subjects only needed to have an MNWS at one of these time points (weeks 7-10) to be included in the analysis.|||units on a scale||Standard Error|Mean
1463322|NCT00755716|Primary|Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.|The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.|weeks 7-10||||Participants|||Count of Participants
1463323|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 12 weeks||||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
1463324|NCT00755417|Primary|Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe.|From baseline to 4 weeks||||Score on a numerical scale||95% Confidence Interval|Least Squares Mean
1463325|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|Form baseline to 12 weeks||||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
1463326|NCT00755417|Primary|Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo|Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population.|From baseline to 4 weeks||||Moderate or severe hot flashes||95% Confidence Interval|Least Squares Mean
1463327|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Fold-rises in vaccine Influenza titers were determined in the per-protocol population. (Data is part of Outcome 7, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1463328|NCT00755274|Other Pre-specified|Percentage of Participants With at Least a 4-Fold Rise in Influenza Titers After Fluzone® Vaccination (Seroconversion)|Seroconversion was defined as a ≥ 4-fold increase in post-vaccination Hemagglutination inhibition titer. Data presented for all participants and those enrolled at age 6 to 35 months of age.|Day 28 post-single dose or Day 21 post-Dose 2|"Four-fold rises in vaccine Influenza titers were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1463329|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for participants enrolled at age 36 to 59 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population. (Data is part of Outcome 5, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed groups did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1463330|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 2|Safety analysis (post-vaccination 2) was on all enrolled and vaccinated participants with available data, intent-to-treat population. (Data is part of Primary Outcome 1, no data were generated for the Primed Group)|||Participants|||Number
1463346|NCT00755131|Secondary|Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months|Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute.|Baseline and 6-month follow-up|intention to treat (ITT) analysis|||ml/kg/min||Standard Deviation|Mean
1463331|NCT00755274|Other Pre-specified|Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)|Seroprotection was defined as a post-vaccination Hemagglutination inhibition titer ≥ 1:40. Data presented for all participants and those enrolled at age 6 to 35 months.|Day 28 post-single dose or Day 21 post-Dose 2|"Seroprotection post-vaccination were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Percentage of participants|||Number
1463332|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population. (Data is part of Outcome 3, no data were generated for the Naive/Inadequately Primed Group).~One of the enrolled participants in the Primed group did not have valid post-vaccination serology test data."|||Titers||95% Confidence Interval|Geometric Mean
1463333|NCT00755274|Other Pre-specified|Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination||Day 28 post-single dose or Day 21 post-Dose 2|"Geometric mean titers (GMTs) to the Influenza vaccine antibodies were determined in the per-protocol population.~One each of the enrolled participants in the Primed and Naive groups, respectively, did not have valid post-vaccination serology test data."|||Titers||95% Confidence Interval|Geometric Mean
1463334|NCT00755274|Primary|Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1|Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.|Day 0 to Day 3 post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants with available post-vaccination 1 data, intent-to-treat population.|||Participants|||Number
1463335|NCT00755261|Primary|RECIST|Study was terminated because of low accrual.|6 month PFS|study was terminated because of low accrual (4 subjects enrolled/2 years)||||||
1463336|NCT00755235|Secondary|Treatment Satisfaction|"Single item seven point scale ranging from very satisfied to very dissatisfied"|Measured after 6 months of treatment||||participants|||Number
1463337|NCT00755235|Primary|20-Item Symptom Checklist Depression Scale|20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.|Measured at baseline and after 6 months of treatment|Analysis included all participants participating in outcome assessment|||units on a scale||Standard Deviation|Mean
1463338|NCT00755222|Primary|Change From Baseline in PDQ Penile Pain|Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1463339|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Discomfort|"Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1463340|NCT00755222|Primary|Change From Baseline in PDQ Intercourse Contraint|"Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1463341|NCT00755222|Primary|Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie’s Disease Symptom Bother|"Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'~Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale."|Baseline to Week 36 or LOCF||||scores on a scale||Standard Deviation|Mean
1463342|NCT00755222|Primary|Change From Baseline in Penile Curvature|Negative change reflects improvement in penile curvature|Baseline and Week 36 or last observation carried forward (LOCF)||||Percent change from baseline||Standard Deviation|Mean
1463343|NCT00755196|Secondary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 7, 14, 28, 42, 56, 70 and 91 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque vs. vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 7, 14, 28, 42, 56, 70, 91|ITT population included all randomized participants who received the study medication.|||percentage of participants|||Number
1463344|NCT00755196|Primary|Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84|OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS at Day 84 were reported and comparison of ointment and vehicle treated plaque was given as ‘Ointment treated plaque versus (vs.) vehicle treated plaque’ and ‘Vehicle treated plaque vs. ointment treated plaque’.|Day 84|ITT population included all randomized participants who received the study medication.|||percentage of participants|||Number
1463345|NCT00755131|Other Pre-specified|Heart Rate Recovery at Baseline and 6 Months|"The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system.~Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease."|baseline and 6 month follow-up||||beats/min||Standard Deviation|Mean
1498047|NCT00488033|Secondary|Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization||4 years||||Participants|||Count of Participants
1463347|NCT00755131|Primary|High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months|High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response.|baseline and 6-month follow-up||||ng/ml||Standard Deviation|Mean
1463348|NCT00755105|Primary|Rate of Iron Excretion.|Iron excretion calculated as body Fe (mg) times turnover rate estimated from blood activity of Fe55|4 years|Per protocol|||milligrams per day||95% Confidence Interval|Mean
1463349|NCT00755079|Secondary|Expiratory Respiratory Muscle Strength|Respiratory Muscle Strength defines as Maximal expiratory muscle strength at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.||||cmH2O||Standard Deviation|Mean
1463350|NCT00755079|Primary|Inspiratory Respiratory Muscle Strength|Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.|Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.||||cmH2O||Standard Deviation|Mean
1463351|NCT00755040|Secondary|Numerical Score of Ocular Surface Disease Index (OSDI) and Development or Lack of Ocular GVHD (by Ophthalmologic Examination) as Measured by Odds Ratio in a Linear Regression Model.|OSDI is a patient reported questionnaire consisting of 12 questions which are scored from 0 to 4. The total scored is computed and depending on the number of questions answered scores are computed which are then categorized into mild, moderate or severe dry eye symptoms. This tool should adequately reflect the morbidity of the dry eye symptoms.|1 year after transplant|Not collected/analysed due to staffing constraints||||||
1463352|NCT00755040|Primary|Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)|Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were <5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.|Up to 2 years after transplantation|Number of patients that develop ocular GVHD while on study|||participants|||Number
1463353|NCT00754923|Secondary|Mutational Status for EGFR or Kras||2008-present||||participants|||Number
1463354|NCT00754923|Secondary|Toxicity||2008-present|||||||
1463355|NCT00754923|Secondary|Overall Survival||2008-present|||||||
1463356|NCT00754923|Primary|Progression-free Survival at 6 Months|"Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate"|6 months||||participants|||Number
1463357|NCT00754832|Secondary|Realtime Digital Fatigue Score|fatigue scored on 0-10 scale with higher scores indicating more fatigue|6 weeks of intervention||||units on a scale||Standard Deviation|Mean
1463358|NCT00754832|Secondary|Modified Fatigue Impact Scale|21 item scale, score range 0-84, lower scores indicate less fatigue|6 weeks of intervention||||units on a scale||Standard Deviation|Mean
1463359|NCT00754832|Primary|Fatigue Severity Scale|The Fatigue Severity Scale (FSS)is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity. The subject is asked to score each statement, based on how the statement applied to them over the preceding week. The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.|after 6 weeks of intervention|intention to treat|||units on a scale||Standard Deviation|Mean
1463360|NCT00754793|Primary|Sino-Nasal Outcome Test-20 (SNOT-20)||baseline, 1 month, 3 months|||||||
1463361|NCT00754767|Primary|Vibratory Threshold as Assessed by the Rydel-Seiffer Quantitative Tuning Fork|Data was not analyzed due to study termination|baseline, days 1 and 2 post chemo x 4 cycles|||||||
1463362|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 36 months post randomization||||participants|||Number
1463363|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1463364|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1463365|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 18 months post randomization represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 18 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1463437|NCT00754494|Secondary|Plasma OSI-420 Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mL||Standard Deviation|Mean
1468012|NCT00721188|Secondary|Initial Volume of Distribution (Vdc)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
1463366|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 12 months post randomization represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 12 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1463367|NCT00754741|Secondary|LDL Cholesterol Levels||at 12 months post randomization||||mg/dL||Standard Deviation|Mean
1463368|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 12 months post randomization||||Percent||Standard Deviation|Mean
1463369|NCT00754741|Secondary|LDL Cholesterol Levels||at 6 months post randomization||||mg/dL||Standard Deviation|Mean
1463370|NCT00754741|Secondary|Glycated Hemoglobin Levels||at 6 months post randomization||||Percent||Standard Deviation|Mean
1463371|NCT00754741|Secondary|Cardiovascular Morbidity and Mortality (Exploratory)||at 24 months post randomization||||participants|||Number
1463372|NCT00754741|Secondary|Adherence to Lipid-lowering Drugs|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1463373|NCT00754741|Secondary|Adherence to Oral Anti-diabetic Medications|"Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at 6 months post randomization represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date."|at 6 months post randomization||||Adherence - proportion||Standard Deviation|Mean
1463374|NCT00754741|Primary|LDL-cholesterol Levels||at 18 months post randomization||||mg/dL||Standard Deviation|Mean
1463375|NCT00754741|Primary|Glycated Hemoglobin Levels||at 18 months post randomization||||Percent||Standard Deviation|Mean
1463376|NCT00754650|Secondary|Best Overall Response (BOR)|The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.|||Percentage of participants|||Number
1463377|NCT00754650|Primary|Bone Marrow Response|Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.|Baseline to the end of treatment (up to 24 weeks)|Intent-to-treat population: All participants who received at least 1 administration of the study drug.|||Percentage of infiltration||Inter-Quartile Range|Median
1463378|NCT00754624|Secondary|High Resolution Computerized Tomography Scans of the Chest||End of study|participants in Safety population with available post-baseline data|||participants|||Number
1463379|NCT00754624|Secondary|Change in Weight in kg From Baseline to End of Study|Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months)|Safety|||kilograms||Standard Deviation|Mean
1463380|NCT00754624|Secondary|Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months)|Change from Baseline to last study measurement on treatment (maximum of 48 months)|Baseline to last study measurement on treatment (maximum of 48 months)||||milligrams per deciliter||Standard Deviation|Mean
1463381|NCT00754624|Secondary|Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months)|Change in HbA1c from Baseline to last measurement on study drug (maximum of 48 months)|Baseline to last measurement on study drug (maximum of 48 months|Safety|||percentage||Standard Deviation|Mean
1463382|NCT00754624|Secondary|Annual Rate of Change in DLCo From Baseline to End of Study||Baseline to 48 months|Safety|||mL/min/mmHg per year||Standard Error|Mean
1463383|NCT00754624|Secondary|Annual Rate of Change in FVC From Baseline to End of Study||Baseline to 48 months|Safety|||Liters per year||Standard Error|Mean
1463384|NCT00754624|Primary|Annual Rate of Change in FEV1 From Baseline to End of Study||Baseline to 48 months|Safety Population defined as all subjects who received at least one dose of study drug|||Liters per year||Standard Error|Mean
1463385|NCT00754572|Secondary|Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
1463386|NCT00754572|Secondary|Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
1463438|NCT00754494|Secondary|Plasma Erlotinib Concentration (ng/mL)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mL||Standard Deviation|Mean
1463387|NCT00754572|Secondary|Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24|DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity and DAS28<2.6 = remission|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1463388|NCT00754572|Secondary|Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population. All participants with endpoint values collected at Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
1463389|NCT00754572|Secondary|AUC of DAS28|The AUC was computed using the trapezoidal rule, considering baseline value as 0, through NCSS software. For each participant, AUC for DAS28 units was calculated. Each individual AUC DAS28 value was divided by 52 to have the conversion of AUC DAS28 in unit weeks to AUC DAS28 in unit years, as 1 week is approximately 1/52 years. The set of individual AUC DAS28 was computed as summary statistics.|Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||scores on a scale * years||Standard Deviation|Mean
1463390|NCT00754572|Secondary|Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24|DAS28- based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with DAS28 < 3.2; moderate response: change from baseline >1.2 with DAS28 >3.2 to <5.1 or change from baseline >0.6 to <1.2 with DAS28 <5.1; No response: change from baseline < 0.6 or change from baseline >0.6 and <1.2 with DAS28 >5.1.|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||Percentage of Participants||95% Confidence Interval|Number
1463391|NCT00754572|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24|DAS28 calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 (less than or equal to ) ≤3.2 = low disease activity, DAS28 (greater than) >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
1463392|NCT00754572|Secondary|Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models|The probability of ACR positive response was determined using the GEE.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||odds||95% Confidence Interval|Number
1463393|NCT00754572|Secondary|Percentage of Participants Achieving ACR20 Response|"ACR20 is defined as 20% improvement in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the HAQ-DI~Acute phase reactant levels - ESR or CRP"|Week 2|ITT Population; All participants with endpoint values collected at Week 2 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1463394|NCT00754572|Secondary|Area Under The Curve (AUC) of the ACR(n)|ACR-n was defined as the lowest of 3 values (the percent change in the swollen joint count, the percent change in the tender joint count, and the median of the other 5 measures in the ACR core data set which included Participant's global assessment of pain (VAS), Participant's global assessment of disease activity (VAS), Investigator/Physician's global assessment of disease activity (VAS), Participant's assessment of disability measured by the HAQ-DI Acute phase reactant levels - ESR or CRP). Therefore, a percentage value was assigned to each participant at each timepoint. AUC was calculated for each participant from baseline to Week 112. Mean and standard deviation values are are provided in percent*years.|Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24|ITT Population; All participants with endpoint values collected were included in the analysis.|||percent*years||Standard Deviation|Mean
1463395|NCT00754572|Secondary|Percent Change From Baseline in HAQ-DI at Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1463396|NCT00754572|Secondary|HAQ-DI at Baseline and Week 24|HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 =without difficulties; 1= with some difficulties; 2=with great difficulties; and 3= unable to perform these actions at all. Minimum score was 0, maximum score was 3. A positive change from baseline represents an improvement (reduced level of impairment).|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified time point.|||units on a scale||Standard Deviation|Mean
1498048|NCT00488033|Secondary|Number of Participants Suffering Cardiovascular (CV) Death||4 years||||Participants|||Count of Participants
1463397|NCT00754572|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1463398|NCT00754572|Secondary|Physician's Global Assessment of Disease Activity at Baseline and Week 24|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity). The physicians marked the line corresponding to their assessment and the distance from the left edge was measured. A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n=number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
1463399|NCT00754572|Secondary|Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1463400|NCT00754572|Secondary|Participant's Global Assessment of Disease Activity at Baseline and Week 24|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A positive change from baseline represents an improvement (reduced level of disease activity)."|Baseline and Week 24|ITT Population. All participants with endpoint values collected at the specified timepoints were included in the analysis. n= number of participants analyzed for the given parameter at the specified time point.|||mm||Standard Deviation|Mean
1463401|NCT00754572|Secondary|Percent Change From Baseline in Pain as Assessed by the Participant at Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at Baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1463402|NCT00754572|Secondary|Pain as Assessed by the Participant at Baseline and Week 24|"The participants assessed their pain using a 0 to 100 millimeter (mm) VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. The participants marked the line corresponding to the level of their pain and the distance from the left edge was measured. A positive change from baseline represents an improvement."|Baseline and Week 24|ITT Population; All participants with endpoint values collected at the specified timepoints were included in the analysis. number (n) equals (=) number of participants analyzed for the given parameter at the specified time point.|||mm||Standard Deviation|Mean
1463403|NCT00754572|Secondary|Percent Change From Baseline in SJC and TJC at Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||percent change||Standard Deviation|Mean
1463404|NCT00754572|Secondary|SJC and TJC at Baseline and Week 24|The number of swollen joints (66 joint count) were scored as swollen=1 and not swollen=0, and the number of tender joints (68 joint count ) were scored as tender=1 and not tender=0, and counted. Scores ranged from 0 to 66 for swollen joint counts and from 0 to 68 for tender joint counts. A positive change from baseline represents an improvement (a reduction in the number of swollen or tender joints).|Baseline and Week 24|ITT Population; All participants with endpoint values collected at both baseline and Week 24 were included in the analysis.|||joints||Standard Deviation|Mean
1463405|NCT00754572|Secondary|Change From Baseline in Hemoglobin at Week 24||Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
1463406|NCT00754572|Secondary|Time to Onset of ACR20, ACR50, and ACR70|"ACR20, ACR50 and ACR70 are defined as 20, 50 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Baseline and Week 24|Data were not analyzed because of inconsistencies in the pooled data between countries.||||||
1463407|NCT00754572|Secondary|Percentage of Participants With ACR20 and ACR70 Response at Week 24|"ACR20 and ACR70 are defined as 20 and 70 percent improvement respectively in: a) SJC and TJC and b) Three of the following 5 assessments:~Participant's global assessment of pain by VAS~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by HAQ-DI~Acute phase reactant (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1463408|NCT00754572|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24|"ACR50 is defined as 50 percent (%) improvement in: a) Swollen Joints Count (SJC) and Tender Joints Count (TJC) and b) Three of the following 5 assessments:~Participant's global assessment of pain by Visual Analog Scale (VAS)~Participant's global assessment of disease activity (VAS)~Investigator/Physician's global assessment of disease activity (VAS)~Participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)~Acute phase reactant levels - Erythrocyte Sedimentation Rate or C-Reactive Protein (ESR or CRP)"|Week 24|ITT Population; All participants with endpoint values collected at Week 24 were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1463409|NCT00754559|Secondary|Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response|Participants who withdrew from study drug due to other reasons were not taken into account.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; participants who withdrew from study drug due to other reaasons were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1463410|NCT00754559|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR)|ESR is an inflammation marker used to determine acute phase response.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.|||mm/h||Standard Deviation|Mean
1463411|NCT00754559|Secondary|Changes in C-Reactive Protein|CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.|Baseline, Weeks 1, 2 ,4 and 24|ITT Population|||mg/L||Standard Deviation|Mean
1463412|NCT00754559|Secondary|Changes in Hemoglobin|Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.|Baseline, Weeks 1, 2, 4 and 24|ITT Population.|||g/dL||Standard Deviation|Mean
1463413|NCT00754559|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Score|The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: “effectiveness”, “side-effects”, “convenience” and “global satisfaction”. All subscale scores range from 0 to 100%, with 100% being the best possible result.|Week 24|ITT Population|||units on a scale||Standard Deviation|Mean
1463414|NCT00754559|Secondary|Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF|Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2 and 4|ITT Population; Missing data were imputed using LOCF.|||mm||Standard Deviation|Mean
1463415|NCT00754559|Secondary|Duration of Morning Stiffness as Assessed Using PTHF|Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline, Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.|||hours||Standard Deviation|Mean
1463416|NCT00754559|Secondary|Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)|Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.|Baseline and Weeks 1, 2, and 4|ITT Population; Missing data were imputed using LOCF.|||mm||Standard Deviation|Mean
1463417|NCT00754559|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Week 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1463418|NCT00754559|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1463419|NCT00754559|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 24|ITT Population; Missing data were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
1463420|NCT00754559|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|"CDAI was calculated according to the following formula:~CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity."|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population; only participants with values for CDAI at baseline and the respective visit were included in the analysis.|||units on a scale||Standard Deviation|Mean
1463439|NCT00754494|Secondary|ACF: Normal Mucosa pERK Ratio|Quantification will be performed by Western blot analysis. Tested using analysis of variance with subsequent pairwise comparisons using the Tukey method to adjust for multiple comparisons.|Up to day 30|ACF: pERK ratio not reported as the assay did not demonstrate signaling in ACF pERK levels||||||
1499043|NCT00479258|Secondary|Change From Baseline in Body Weight (kg), Height (cm), and Body Mass Index (BMI; kg/m2) and z Score (%);Dose of Insulin;||12 months|||||||
1463421|NCT00754559|Secondary|Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24|"Participant’s global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”).~Physician’s global assessment of disease activity was measured as participant’s current disease activity on a 100-mm horizontal VAS scale (left hand extreme: “no disease activity”; right-hand extreme: “maximum disease activity”)."|Week 24|ITT Population; missing data were imputed using LOCF.|||mm||95% Confidence Interval|Mean
1463422|NCT00754559|Secondary|Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24|Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.|Week 24|ITT Population; missing data were imputed using LOCF.|||mm||95% Confidence Interval|Mean
1463423|NCT00754559|Secondary|Change From Baseline in the Levels of C-Reactive Protein at Week 24|The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.|Week 24|ITT Population; missing data were imputed using LOCF.|||mg/L||95% Confidence Interval|Mean
1463424|NCT00754559|Secondary|Change From Baseline in Swollen and Tender Joint Counts at Week 24|"Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.~Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68."|Week 24|ITT Population; missing data were imputed using last observation carried forward (LOCF).|||Joints||95% Confidence Interval|Mean
1463425|NCT00754559|Secondary|Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response|ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
1463426|NCT00754559|Secondary|Percentage of Participants With a DAS28 Response at Weeks 4 and 24|DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 <2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.|Weeks 4 and 24|ITT Population;|||percentage of participants||95% Confidence Interval|Number
1463427|NCT00754559|Secondary|Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤ 0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Week 24|ITT Population|||Percentage of Participants|||Number
1463428|NCT00754559|Secondary|Absolute Changes in DAS28 From Baseline|DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant rated global assessment of disease activity using 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT Population; only participants with a DAS28 value at baseline were included in the analysis.|||units on a scale||Standard Deviation|Mean
1463429|NCT00754559|Primary|Percentage of Participants With Low Disease Activity Score at Week 24|Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|Week 24|ITT population.|||Percentage of Participants||95% Confidence Interval|Number
1463430|NCT00754546|Secondary|Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise|"linear regression slope of breathlessness - time for arformoterol and for normal saline will be compared between treadmill and cycle exercise~The higher the number the worse the shortness of breath"|After one dose||||breathlessness units/min||Standard Deviation|Least Squares Mean
1463431|NCT00754546|Primary|Exercise Endurance Time|Participants were asked to exercise until symptom limitation|After one dose|Number of participants determined by previous studies. Analysis was intention to treat|||seconds||Standard Deviation|Mean
1463432|NCT00754494|Secondary|Number of Participants Reported at Least 1 Diarrhea Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks||||participants|||Number
1463433|NCT00754494|Secondary|Number of Participants Reported at Least 1 Rash Side Effect During the Study|Described for each arm using frequencies.|Up to 9 weeks||||participants|||Number
1463434|NCT00754494|Secondary|Number of Participants Reported at Least 1 Side Effect During the Study|Described for each arm using frequencies. The onset of adverse events is between randomization date and off-study date.|Up to 9 weeks||||participants|||Number
1463435|NCT00754494|Secondary|Normal Mucosa OSI-420 Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mg||Standard Deviation|Mean
1463436|NCT00754494|Secondary|Normal Mucosa Erlotinib Concentration (ng/mg)|Will be quantified in biopsy samples using appropriate descriptive statistics (means and standard deviations).|Up to day 30|Outcome measure data is reported based on the evaluable samples collected and available results.|||ng/mg||Standard Deviation|Mean
1499044|NCT00479258|Secondary|Change From Baseline in Insulin Antibodies (microU/mL);||12 months|||||||
1463440|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in ACF|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1463441|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in ACF|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1463442|NCT00754494|Secondary|Change in EGF-inducible Markers - Total EGFR in Normal Mucosa|Total EGFR expression levels were quantified by immunoblotting and calculated as the ratio of the total EGFR signals to reference signals. A log-transformation of total EGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1463443|NCT00754494|Secondary|Change in EGF-inducible Markers - pEGFR in Normal Mucosa|pEGFR expression levels were quantified by immunoblotting and calculated as the ratio of the pEGFR signals to reference signals. A log-transformation of pEGFR was utilized in primary analyses. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|From baseline to post-treatment (up to 30 days)|Outcome measure data is reported based on the evaluable samples collected and available results.|||expression level||95% Confidence Interval|Geometric Mean
1463444|NCT00754494|Primary|Change in ACF pERK Levels|Quantification will be performed by Western blot analysis. Tested using paired t-test with a two-sided significance level of 0.05.|From baseline to post-treatment (up to 30 days)|Change in ACF pERK levels not reported as the assay did not demonstrate signaling||||||
1463445|NCT00754468|Secondary|Side Effects of Subjects Receiving Cryospray Therapy.||End of Study||||side effects|||Number
1463446|NCT00754468|Primary|Depth of Injury|histopathological findings analyzed to determine max depth of injury (mm)|End of Study||||millimeters|Participants|80% Confidence Interval|Mean
1463447|NCT00754442|Secondary|The Number of Patients With Mutations in CYP27B1|CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data|blood samples taken at baseline and sequenced over several days|All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons|||participants|||Number
1463448|NCT00754442|Primary|The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours|1,25-D was measured at baseline, 4 and 8 hours after PTH infusion|baseline, 4 and 8 hours after start of infusion|The final analysis was made on participants with glomerular filtration rate (GFR) of 70 and above since <70, 1,25-D production decreases. After study completion, it was noted that one participant in each group (patient and control) had GFR<70 so these two participants were excluded from final analysis.|||pg/ml||Standard Deviation|Mean
1463449|NCT00754390|Primary|Zinc Absorption|Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time|16 weeks|Analysis restricted to women who completed all 4 treatment periods|||Percentage of Zinc-65 absorbed||Standard Error|Mean
1463450|NCT00754377|Secondary|Change in Knowledge Scores About Quality Improvement|Residents' knowledge was assessed using the knowledge scale (e.g., describe change concept, how a cause-effect diagram is created, elements of the improvement model) from the SQI TAT and scores could range from 0 to 54 points. Difference scores were used based on total score of the scale with larger positive values indicating more increase in knowledge.|1 Month||||units on a scale||Standard Deviation|Mean
1463451|NCT00754377|Primary|Beliefs About Ability to Implement a CQI Project|Residents' belief about their ability to implement a CQI project was measured using a single efficacy item (values ranged from 1, strongly disagree, to 5, strongly agree). The item is from the Systems Quality Improvement Training and Assessment Tool. Differences (post minus pre) in this belief item were looked at with positive and higher difference values reflecting more positive change/increase in belief.|1 month||||units on a scale||Standard Deviation|Mean
1463452|NCT00754338|Primary|Lens Deposits|Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1463453|NCT00754338|Primary|Lens Wettability|Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1463481|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Tmax measurement|||hr||Full Range|Median
1499045|NCT00479258|Secondary|Proportion of Subjects Achieving ADA Age Appropriate Guidelines for HbA1c||12 months|||||||
1463454|NCT00754338|Secondary|Corneal Staining|"Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.~Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.~A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining."|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1463455|NCT00754338|Secondary|Subjective Vision|Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1463456|NCT00754338|Secondary|Dryness|Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.|4 weeks|analysis was per protocol|||Units on a Scale||Standard Deviation|Mean
1463457|NCT00754338|Primary|Comfort|Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.|4 weeks|analysis was per protocol|||Units on a scale||Standard Deviation|Mean
1463458|NCT00754325|Secondary|Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Safety Population on initial treatment; any participants that was randomized to any treatment group in the study and received at least one treatment therapy.|||participants|||Number
1463459|NCT00754325|Secondary|Number of Participants With Best Overall Response|Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment with measurable lesion by RECIST (Response Evaluation Criteria In Solid Tumors). Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||participants|||Number
1463460|NCT00754325|Secondary|Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)|Table represents the best response achieved over this time frame. CR = Disappearance of all target lesions. No new lesions. PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||participants|||Number
1463461|NCT00754325|Secondary|Percentage of Participants With Clinical Benefit for At Least 6 Months|Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination, radiological assessment, and bone scans (if applicable) were used to assess outcome.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1463462|NCT00754325|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan Meier assessments were used to estimate the percentages.|at 6 months|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||percentage of participants||95% Confidence Interval|Number
1463482|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a Cmax measurement|||nmol/L||Standard Deviation|Mean
1499046|NCT00479258|Secondary|Slope for Other PFT Parameters;||12 months|||||||
1463463|NCT00754325|Secondary|Median Time of Progression-free Survival (PFS)|Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders.|||months||95% Confidence Interval|Median
1463464|NCT00754325|Primary|Number of Participants With Disease Progression (PD) or Death|This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.|Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)|Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included as non-responders. Censored participants = 15 Fulvestrant and Dasatinib, 9 Fulvestrant|||participants|||Number
1463465|NCT00754234|Primary|Nonheme Iron Absorption|Absorption was estimated from whole body retention of a Iron-59 radiotracer, 2 weeks after consuming a menu labeled with the isotope, then normalized to a ferritin of 15 nanogram/milliLiter (ng/mL)|2 weeks (wks)|Analysis was per protocol|||percentage of nonheme Iron absorbed||Standard Deviation|Log Mean
1463466|NCT00754208|Secondary|Clinical Global Impression- Improvement|The Clinical Global Impression-Improvement scale is a measure of the clinician's assessment of the overall degree of improvement in ADHD symptoms from baseline to endpoint. The CGI-I is rated on a 1 to 6 scale, with 1=very much improved, 2=much improved, 3=minimally improved, 4= no change, 5= minimally worse, 6=much worse.|8 weeks||||Participants|||Count of Participants
1463467|NCT00754208|Secondary|Change in Children's Global Assessment Scale (CGAS) Score|This measures the change in the subject's global assessment of functioning as rated by the clinician. This Children's Global Assessment Scale (CGAS) is rated on a 0-100 scale (refer to baseline information). The change in this score is the difference between the score at baseline to end point.|8 weeks||||units on a scale||Standard Deviation|Mean
1463468|NCT00754208|Secondary|Change in Clinical Global Impression-Severity|Change in global rating of severity of ADHD symptoms. CGI severity is rated on a scale of 1 to 6 (normal to severely ill; refer to description in baseline information). The change in the severity rating reflects the change in this score from baseline to endpoint.|8 weeks||||units on a scale||Standard Deviation|Mean
1463469|NCT00754208|Primary|Change in Attention Deficit Hyperactivity Disorder Rating Scale-IV Parent Version Investigator-Scored (ADHD-IV-Parent: Inv) Total Score.|Change from baseline to endpoint of investigator-scored, parent version of the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-IV rating scale). The ADHD-IV contains 18 items, and each item is rated 0, 1, 2 or 3. Minimum score is 0. Maximum score is 54. Change in score represents the difference between the total score at end point compared to the total score at baseline.|8 weeks||||units on a scale||Standard Deviation|Mean
1463470|NCT00754156|Secondary|Blood Transfused||Duration of Hospital Stay less than 6 months||||Units||Inter-Quartile Range|Median
1463471|NCT00754156|Secondary|Hospital Days||Duration of Hospital Stay less than 6 months||||Days||Inter-Quartile Range|Median
1463472|NCT00754156|Secondary|ICU Days||Duration of hospital stay less than 6 months||||Days||Inter-Quartile Range|Median
1463473|NCT00754156|Secondary|Days to Closure||Duration of Hospital Stay less than 6 months||||Days||Inter-Quartile Range|Median
1463474|NCT00754156|Primary|Operating Room Time Utilization|The amount of time needed to manage the open abdomen inside the operating room.|Duration of Hospital Stay less than 6 months||||Minutes||Standard Deviation|Mean
1463475|NCT00754156|Primary|Number of Trips to the Operating Room||12 Months||||Number of trips||Inter-Quartile Range|Median
1463476|NCT00754156|Primary|Primary Closure Rate|The rate in which the abdomen was closed the first time.|up to 12 months|Descriptive Study.|||% of participants|||Number
1463477|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr|Geometric Mean of the Day 5 to Day 1 Accumulation Ratio|Day 5 and Day 1|All participants with pharmacokinetic measurements on Days 1 and 5|||Ratio||Full Range|Geometric Mean
1463478|NCT00754130|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.|||participants|||Number
1463479|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a t1/2 measurement|||hr||Standard Deviation|Mean
1463480|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with a C24hr measurement|||nmol/L||Standard Deviation|Mean
1463483|NCT00754130|Secondary|Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941|Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.|Up to 72 hours after study drug administration|Participants with an AUC(0-24hr) measurement|||nmol*hr/L||Standard Deviation|Mean
1463484|NCT00754130|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.~Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2."|Up to 14 days after last dose of study drug|Safety Population, consisting of all randomized participants who received at least one dose of study drug.|||participants|||Number
1463485|NCT00754065|Other Pre-specified|The Change of Pelvic Pain or Headache as Determined by the Highest Visual Analog Scale (VAS) Values During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
1463486|NCT00754065|Other Pre-specified|Percentage of Participants With no Increase in Rescue Medication and VAS Decrease During Cycle Days 22 to 28 From Baseline to Cycle 6|Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463487|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 13|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463488|NCT00754065|Secondary|Percentage of Participants With Improvement in the Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6|In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463489|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 13|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463490|NCT00754065|Secondary|Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6|CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463491|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463492|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Overall Life Satisfaction and Contentment|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463493|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1499047|NCT00479258|Secondary|Change From Baseline in FVC||12 months|||||||
1499048|NCT00479258|Secondary|Treatment Preferences.||12 months|||||||
1463494|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Item Satisfaction|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463495|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463496|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – General Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463497|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463498|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Social Relationship|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463499|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463500|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Leisure Time Activities|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463501|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463502|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – School/Course Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463503|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463504|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Household Duties|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties – yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463505|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463506|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Work|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work – yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463507|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463508|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Participant Feeling|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463509|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463510|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) – Physical Health|Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463511|NCT00754065|Secondary|Mean Change From Baseline to Cycle 13 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463512|NCT00754065|Secondary|Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI)|Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best).|Baseline up to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463513|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463514|NCT00754065|Secondary|Percentage of Participants With at Least 1 Intracyclic Bleeding Episode at Cycles 2 to 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|Cycles 2 to 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463515|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463516|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463517|NCT00754065|Secondary|Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463520|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463521|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463522|NCT00754065|Secondary|Number of Intracyclic Bleeding Days at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463523|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463524|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463525|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463526|NCT00754065|Secondary|Maximum Length of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463527|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463528|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463529|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463530|NCT00754065|Secondary|Number of Intracyclic Bleeding Episodes at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding)|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463531|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 13|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463532|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463533|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463534|NCT00754065|Secondary|Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1|Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463535|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 13|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463536|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 6|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463537|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 3|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463538|NCT00754065|Secondary|Onset of Withdrawal Bleeding Episodes at Cycle 1|Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM).|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463539|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 13|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463540|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463541|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463542|NCT00754065|Secondary|Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1|Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Scores on a scale||Standard Deviation|Mean
1463543|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463544|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463545|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463546|NCT00754065|Secondary|Length of Withdrawal Bleeding Episodes at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463547|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 13|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463548|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463549|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463550|NCT00754065|Secondary|Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1|Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end.|At Cycle 1 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Percentage of participants|||Number
1463551|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463552|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463553|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463554|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463555|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463556|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463557|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463558|NCT00754065|Secondary|Maximum Length of Spotting-only Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463559|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463560|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463561|NCT00754065|Secondary|Mean Length of Spotting-only Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463569|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463570|NCT00754065|Secondary|Number of Days With Spotting-only in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463571|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463572|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463573|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463574|NCT00754065|Secondary|Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463575|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463576|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463577|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463578|NCT00754065|Secondary|Maximum Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463579|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463580|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463581|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463582|NCT00754065|Secondary|Mean Length of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463583|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463584|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463585|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting)|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463586|NCT00754065|Secondary|Number of Bleeding / Spotting Episodes in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting)|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Episodes||Standard Deviation|Mean
1463587|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 4|Reference Period 4 is defined as Day 271 to Day 360 during study treatment.|From Day 271 to Day 360|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463588|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 3|Reference Period 3 is defined as Day 181 to Day 270 during study treatment.|From Day 181 to Day 270|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463589|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 2|Reference Period 2 is defined as Day 91 to Day 180 during study treatment.|From Day 91 to Day 180|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1464641|NCT00744380|Primary|Time From Study Drug Initiation to Tracheal Extubation||Duration of ICU stay, for up to 24 weeks|The analysis only includes patients successfully extubated for at least 72 hours. Eight subjects were excluded.|||days||Inter-Quartile Range|Median
1463590|NCT00754065|Secondary|Number of Days With Bleeding or Spotting in Reference Period 1|Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.|From Day 1 to Day 90|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463591|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
1463592|NCT00754065|Secondary|Change From Baseline to Cycle 3 in the Average of the Three Highest VAS Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||mm||Standard Deviation|Mean
1463593|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group.|From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463594|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During the Hormone-free Interval Cycle Days 27 to 28 for EV/DNG and Cycle Days 22 to 28 for EE/NGM|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group.|From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463595|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463596|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Individual Hormone-related Symptoms During Cycle Days 1-21|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst).|Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463597|NCT00754065|Secondary|Change From Baseline to Cycle 13 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1463598|NCT00754065|Secondary|Change From Baseline to Cycle 6 in the Number of Days With at Least Moderate Pain/Intensity of Other Hormone-related Symptoms During Cycle Days 22-28|Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Days||Standard Deviation|Mean
1464642|NCT00744328|Secondary|To Explore the Relationship of Remission and Response to the Subjects’ Serum Levels of Estradiol.||Monthly|||||||
1463599|NCT00754065|Secondary|The Change From Baseline to Cycle 13 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived.|From Baseline to Cycle 13 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
1463600|NCT00754065|Secondary|The Change From Baseline to Cycle 6 in the Number of Ibuprofen Tablets Used as Rescue Medication|Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived.|From Baseline to Cycle 6 (28 days per Cycle)|All participants in FAS with assessment for this outcome measure|||Tablets||Standard Deviation|Mean
1463601|NCT00754065|Primary|The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28 From Baseline to Cycle 6|Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst).|Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)|All participants in Full Analysis Set (FAS) with assessment for this outcome measure|||mm||Standard Deviation|Mean
1463602|NCT00754052|Secondary|Mean Change From Baseline if the Forward Memory and Attention Sustained Sub-tests of the Leiter International Performance Scale - Revised (Leiter-R)|Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent was planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1463603|NCT00754052|Secondary|Mean Change From Baseline in Test of Verbal Expression and Reasoning (TOVER)|TOVER, a subject performance-based measure of expressive language function was planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1463604|NCT00754052|Secondary|Mean Change From Baseline in Additional Analyses of the VABS-11/PCRF|Additional analyses of the VABS-II/PCRF were planned.|Baseline (Day 0) to Visit 3 (Week 10) or early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1463605|NCT00754052|Primary|Mean Change From Baseline in Vineland-II Adaptive Behavior Scale (VABS-II) Parent/Caregiver Rating Form (PCRF) Score Using Last Observation Carried Forward (LOCF)|Mean change from Baseline from Visit 1 (baseline) to Visit 3 (Week 10 or early termination) in VABS-11/PCRF, a sum of the 9 sub-domain v-scores (3 scores for each of the communication, daily living skills, and socialization domains) using last observation carried forward was planned.|Baseline (Day 0) to Visit 3 (Week 10) or at early termination|Because the study was terminated early, only 8 subjects were enrolled. Analyses were not performed due to study medication exposure being limited and variable, limited efficacy data were collected, and no participant reached their maximum targeted dose.||||||
1463606|NCT00754013|Secondary|Mean Change From(Baseline) to Visit 3(Week 10 or Early Termination) in VABS-II/PCRF Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The planned secondary objectives of the study included further evaluation of efficacy as assessed by additional analyses of the VABS-II/PCRF, by analyses of the Test of Verbal Expression and Reasoning (TOVER), a subject-performance-based measure of expressive language function, and by the Forward Memory and Attention Sustained sub-tests of the Leiter International Performance Scale - Revised (Leiter-R), a cognitive assessment instrument for children and adolescents that is not language dependent. In addition, observed case analyses of these assessments at Week 4 and Week 10 were planned.|Visit 1 (Baseline) to Visit 3 (Week 10 or early termination).|This study was terminated early. Secondary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.||||||
1463607|NCT00754013|Primary|Vineland-II Adaptive Behavior Scales (VABS-II) Parent/Caregiver Rating Form (PCRF) Sum of the 9 Sub-domain V-scores (3 Scores for Each of the Communication, Daily Living Skills, and Socialization Domains) Using Last Observation Carried Forward.|The primary objective of the study was evaluation of the efficacy and safety of donepezil hydrochloride in the treatment of the cognitive dysfunction exhibited by children with Down syndrome (DS), aged 6 to 10, as assessed by analysis of VABS-II/PCRF in the domains of communication, daily living skills, and socialization, and as assessed by standard safety measurements.|Visit 0 (Screen), Visits 1 (Baseline), 2, and 3 (or Early Termination).|The planned efficacy analysis was on the intent-to-treat (ITT) population. This study was terminated early. Primary efficacy data were not analyzed since only 9 of the 140 planned subjects had been enrolled.||||||
1463608|NCT00753948|Secondary|Methacholine Challenge||During study visits, methacholine challenge will be performed 120 minutes post intervention.|||||||
1463609|NCT00753948|Secondary|Lung Function as Measured by Plethysmography||During study visits, measures are obtained prior to intervention (intravenous or nebulized) and 60, 120 minutes post intervention.|||||||
1463610|NCT00753948|Primary|Exhaled Levels of Nitric Oxide|Nitric Oxide was measured applying a real time technique for measurement of Nitric Oxide in Exhaled Breath Condensate. Elevated Nitric Oxide in exhalate is a measure of elevated production of NO in conditions such as underlying inflammation and/or oxidative stress|Exhaled NO was reported as the mean of three values within 10% of each other.||||ppb (parts per bilion)||Standard Deviation|Mean
1463611|NCT00753935|Primary|Change in Serum Thromboxane B2|Thromboxane A2, the major product of cyclooxygenase cytochrome oxidase (COX-1) in platelets, induces platelet aggregation. Thromboxane B2 is an inactive metabolite/product of thromboxane A2. This primary outcome measures the extent of inhibition of platelet COX-1 by measuring the amount of the metabolite thromboxane B2 in serum.|after 2 weeks on aspirin||||ng/mL||Inter-Quartile Range|Median
1463612|NCT00753922|Post-Hoc|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Complications|The safety analyses were conducted in accordance with the FDA November 17, 2006 “Guidance for Industry and FDA Staff – Saline, Silicone Gel, and Alternative Breast Implants.” The study investigator assessed any complications durign study follow-up visits in alignment with this guidance. Time of occurrence was calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. Complications with an incidence > 5.0% are reported.|10 years|All Enrolled Subjects|||percentage of subjects||95% Confidence Interval|Number
1463613|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
1463614|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
1463615|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|10 Years|All enrolled subjects|||percentage of subjects||95% Confidence Interval|Number
1463616|NCT00753922|Primary|Overall Mean Change in Circumferential Chest Size|Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study|Change from baseline to 10 years post-baseline|All enrolled subjects|||centimeters||Standard Deviation|Mean
1463617|NCT00753922|Primary|10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|10 years|All enrolled subjects are included|||percentage of subjects||95% Confidence Interval|Number
1463618|NCT00753896|Secondary|Change in Blood Pressure From Baseline to Week 52|Change in Systolic and Diastolic Blood Pressure from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmHg||Standard Error|Mean
1463619|NCT00753896|Secondary|Change in Triglycerides From Baseline to Week 52|Change in Triglycerides from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1463620|NCT00753896|Secondary|Change in High-density Lipoprotein (HDL) From Baseline to Week 52|Change in HDL from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1463621|NCT00753896|Secondary|Change in Total Cholesterol From Baseline to Week 52|Change in Total Cholesterol from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1463622|NCT00753896|Secondary|Change in Body Weight From Baseline to Week 52|Change in body weight from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||kg||Standard Error|Mean
1463623|NCT00753896|Secondary|Change in Fasting Serum Glucose From Baseline to Week 52|Change in fasting serum glucose from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||mmol/L||Standard Error|Mean
1463624|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=6.5% at Week 52|Percentage of patients achieving HbA1c <=6.5% at endpoint (for patients with HbA1c >6.5% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 6.5%. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
1463625|NCT00753896|Secondary|Percentage of Patients Achieving HbA1c <=7% at Week 52|Percentage of patients achieving HbA1c <=7% at endpoint (for patients with HbA1c >7% at baseline)|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug and whose baseline HbA1c was > 7% . Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of patients|||Number
1463626|NCT00753896|Secondary|Change in HbA1c From Baseline to Week 52|Change in HbA1c from baseline to endpoint|Baseline, Week 52|All enrolled patients who had taken at least one dose of study drug. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.|||percentage of total hemoglobin||Standard Error|Mean
1463627|NCT00753896|Primary|Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events|Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)**2).|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.|||events per subject-year||Standard Error|Mean
1463628|NCT00753896|Primary|Percentage of Patients Experiencing Adverse Events|Percentage of patients experiencing treatment-emergent adverse events over 52 weeks|Baseline to Week 52|All enrolled patients who had taken at least one dose of study drug. Sample size based on FDA recommendation for safety exposure: a minimum of 100 patients completing at least 52 weeks of treatment is sought to assess long-term safety associated with exposure to exenatide once weekly.|||percentage of patients|||Number
1463629|NCT00753766|Secondary|Rate of Return to the Operating Room||6 weeks|||||||
1463630|NCT00753766|Secondary|A Composite of Death From Cardiovascular Cause, Non-fatal Myocardial Infarction, Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Nonfatal Stroke, or Amputation as a Result of Peripheral Ischemia||6 weeks|||||||
1463631|NCT00753766|Secondary|Length of Hospital Stay||6 weeks|||||||
1463632|NCT00753766|Secondary|Occurrence of Wound Infection in the 30 Day Post-operative Period||6 weeks|||||||
1463633|NCT00753766|Secondary|Change in A1c & Fructosamine From Baseline to Pre-admission (A1c is the Standard Parameter to Assess Chronic Glucose Control, Fructosamine Provides a Measure of Shorter-term Glucose Control [2-3 Wks])||6 weeks|||||||
1463634|NCT00753766|Secondary|Percent of Participants Not Completing the Protocol Due to the Need for Urgent Surgery and/or Treatment-related Complications||6 weeks||||participants|||Number
1463635|NCT00753766|Secondary|Participant Adherence With the Study Protocol (i.e. Attending Study Visits, CGMS Studies||6 weeks|||||||
1463636|NCT00753766|Primary|Percent of Screened Participants That Are Eligible and Choose Participation||6 weeks||||percentage of potential participants|||Number
1463637|NCT00753714|Secondary|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine|The Safety and Tolerability Profile of ZD6474 (Vandetanib) in Combination With Gemcitabine is defined as the number of Adverse Events which includes any symptoms and/or Clinically Significant Laboratory or Vital Signs Abnormalities, and/or ECGs Changes|Oct 2008- Dec 2011||||Adverse Events|||Number
1463638|NCT00753714|Secondary|Duration of Response||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
1463639|NCT00753714|Secondary|Overall Objective Response||Oct 2008- dec 2011||||Participants|||Number
1463640|NCT00753714|Secondary|Overall Survival||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
1463641|NCT00753714|Primary|Progression Free Survival||Oct 2008- dec 2011||||days||95% Confidence Interval|Median
1463642|NCT00753688|Secondary|Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)|LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal [LLN]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).|Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
1463643|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin|Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
1463656|NCT00753675|Secondary|Objective Tumor Response Rate (CR+PR),|Objective Tumor Response Rate was defined as complete response (CR) + partial response (PR) evaluated by RECIST. CR was defined as disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of longest diameters (LD) of target lesion(s) taking as reference the baseline sum of LD|up to 1032 days|ITT|||Participants|||Number
1463688|NCT00753545|Secondary|Overall Survival (OS)|OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.|Follow up every 12 weeks post progression, assessed maximum up to 90 months.||||Months||95% Confidence Interval|Median
1463644|NCT00753688|Secondary|Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count|Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.|From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||participants|||Number
1463645|NCT00753688|Secondary|Change From Baseline in Heart Rate|Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population. Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||beats per minute||Standard Deviation|Mean
1463646|NCT00753688|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from baseline in on-therapy SBP and DBP was calculated as the values at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.|Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104|Safety Population: all participants who had started their allocated treatment (at least one dose of the study drug). Data were analyzed for participants who were on-therapy and provided data at the indicated time point.|||Millimeters of mercury||Standard Deviation|Mean
1463647|NCT00753688|Secondary|PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization [WHO] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)|"ITT Population. The ns in the category titles represent the number of participants in each treatment arm with the indicated STS."|||weeks||95% Confidence Interval|Median
1463648|NCT00753688|Secondary|Duration of Response Assessed by the Independent Radiologist and the Investigator|Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.|||weeks||95% Confidence Interval|Median
1463649|NCT00753688|Secondary|Time to Response Assessed by an Independent Radiologist and the Investigator|Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.|From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)|ITT Population. Only participants who achieved a confirmed CR or PR, as determined independently by the Independent Radiologist and the Investigator, were analyzed. Only results for the pazopanib arm are given because there was no response in the placebo arm.|||weeks||95% Confidence Interval|Median
1463650|NCT00753688|Secondary|Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator|Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a >=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a >=20% increase in the sum of the LD of TLs, or the appearance of >=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of >=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).|From the start of treatment until disease progression (assessed for an average of 10 months)|ITT Population|||participants|||Number
1463651|NCT00753688|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent [%]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.|From the date of randomization until 215 deaths (assessed for an average of 12 months)|ITT Population|||months||95% Confidence Interval|Median
1463652|NCT00753688|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.|From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)|Intent-to-Treat (ITT) Population: all randomized participants analyzed in the treatment arm they were allocated by randomization.|||weeks||95% Confidence Interval|Median
1463653|NCT00753675|Secondary|Overall Survival|OS is defined from the date of randomization to death|up to 1032 days|ITT|||Days||95% Confidence Interval|Median
1463657|NCT00753675|Primary|Progression Free Survival|Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).|up to 1032 days|ITT|||days||95% Confidence Interval|Median
1463658|NCT00753649|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period up to Last subject last visit on 03/12/2013|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.|||Subjects|||Number
1463659|NCT00753649|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day (Days 0-30) post vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects with at least one dose of Infanrix hexa administration documented.|||Subjects|||Number
1463660|NCT00753649|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1463661|NCT00753649|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL|The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1463662|NCT00753649|Secondary|Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)|A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1463663|NCT00753649|Secondary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
1463664|NCT00753649|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL|For this assay, 1 μg/mL was considered as the seropositivity cut-off.|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1463665|NCT00753649|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).|One month after (POST) Dose 3.|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received 3 doses of Infanrix Hexa vaccine and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
1463666|NCT00753636|Secondary|Pharmacokinetic Data – Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine|Mean Plasma Concentration (+/- SD ng/mL)|1 year||||ng/mL||Standard Deviation|Mean
1463667|NCT00753636|Secondary|Change in Motor UPDRS Scores: Baseline vs. Final Visit|"Baseline visit = Week 0 Final visit = Week 12~Unified Parkinson's Disease Rating Scale (UPDRS)is made up of the following sections:~Part I: evaluation of Mentation, behavior, and mood Part II: self evaluation of the activities of daily life Part III: clinician-scored motor evaluation Part IV: Hoehn and Yahr stating of severity of Parkinson disease. Part V: Schwab and England ADL scale Only part three was used for this assessment.~The higher the UPDRS score, the greater the disability from PD.~The range for scores for Section III is 0 to 108."|12 weeks||||UPDRS Part III Score||Standard Deviation|Mean
1463668|NCT00753636|Secondary|Number of Participants That Completed the Study at Each Dose Level of Isradipine||1 year||||Participants|||Number
1463669|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent|"At the time of enrollment, some patients were currently being treated with antihypertensive agents including Propanolol, Toprol, Lisinopril, Diovan, Norvasc.~HTN+: Participants on an antihypertensive agent HTN-: Participants not on an antihypertensive agent"|1 year||||Participants|||Number
1463670|NCT00753636|Secondary|Number of Participants That Tolerated Each Dose of Isradipine|Tolerability= maximum tolerated dose|1 year||||Participants|||Number
1463671|NCT00753636|Secondary|Safety of the Standard Titration Schedule in PD Population as Measured by the Number of Patients That Are Able to Increase the Dose to 20 mg Daily||1 year||||Participants|||Number
1463672|NCT00753636|Primary|Tolerability of Isradipine Based on the Number of Participants That Complete the Study||1 year||||Participants|||Number
1464643|NCT00744328|Secondary|To Evaluate the Durability of Maternal Response to Estradiol, Sertraline, and Placebo in a Continuation Phase Through the Time the Infant is Assessed at 6.5 Months of Age.||yearly|||||||
1463673|NCT00753623|Primary|Difference in Visual Analog Scale (VAS) for Pain (0-10) Between Treatments|Subjects were asked to rate their pain the VAS with 0 being no pain and 10 being the worst pain they can imagine. The VAS scores were compared between the baseline and after a period of treatment. A negative number indicates an improvement in pain from baseline score.|VAS score at baseline and after the treatment period|Only 15 subjects completed both treatment phases so we only included these subjects in the analysis.|||units on a scale||Standard Deviation|Mean
1463674|NCT00753545|Secondary|Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1463675|NCT00753545|Secondary|Trial Outcome Index(TOI)Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1463676|NCT00753545|Secondary|FACT-O Symptom Index (FOSI) Time to Worsening|The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1463677|NCT00753545|Secondary|Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)|The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
1463678|NCT00753545|Secondary|Improvement Rate for Trial Outcome Index (TOI)|The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
1463679|NCT00753545|Secondary|Improvement Rate for FACT-O Symptom Index (FOSI)|The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]|Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.|Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline|||percentage of evaluable participants|||Number
1463680|NCT00753545|Secondary|Time to Earlier of CA-125 or RECIST Progression|Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1463681|NCT00753545|Secondary|RECIST and CA-125 Response Separately and Combined|RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.||||Participants|||Number
1463682|NCT00753545|Secondary|Best Objective Response|Best overall response from radiologic assessments. [FAS]|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.||||Participants|||Number
1463683|NCT00753545|Secondary|Best Percentage Change in Cancer Antigen 125 (CA-125) Levels|Best percentage change from baseline in CA-125 level|CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.|A subset of the FAS with baseline and at least 1 follow-up value of CA-125|||percentage of change||Full Range|Median
1463684|NCT00753545|Secondary|Percentage Change From Baseline in Tumour Size at Week 24|Percentage change from baseline to Week 24 in target tumour size.|Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.|||Percent change in tumour size||Full Range|Least Squares Mean
1463685|NCT00753545|Secondary|Duration of Response|Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1463686|NCT00753545|Secondary|Disease Control Rate|Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]|Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).||||percentage of participants|||Number
1463687|NCT00753545|Secondary|Objective Response Rate (ORR) (According to RECIST)|For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.|Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline|||percentage of participants|||Number
1464644|NCT00744328|Secondary|Infant Serum Concentrations of Estradiol in 3 Treatment Arms||monthly|||||||
1463689|NCT00753545|Primary|Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])|PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]|Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.||||Months||95% Confidence Interval|Median
1463690|NCT00753519|Secondary|Motor UPDRS|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment).|baseline, 1 day post iTBS||||units on a scale||Standard Deviation|Mean
1463691|NCT00753519|Secondary|Total UPDRS Score|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall assessment scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score consists of mentation, behavior, mood, activities of daily living and motor components, and ranges from 0 (not affected) to 176 (most severely affected). The total UPDRS score is obtained from patient examination, interview and patient questionnaires.|baseline, 1 day post iTBS||||units on a scale||Standard Deviation|Mean
1463692|NCT00753519|Secondary|Bradykinesia|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post iTBS||||seconds||Standard Deviation|Mean
1463693|NCT00753519|Primary|Gait Speed|Gait speed was assessed by measuring the time it takes to walk 10 meters. Subject's gait speed was measured while on medication and off medication for each group, i.e., real iTBS and sham iTBS. Two trials were averaged for each condition. Patients were instructed to walk fast without taking the risk of falling, wearing the same shoes and consistently using assistive devices if needed. Gait speed was measured at baseline, 1 day post intervention, and 1 month post intervention.|baseline, 1 day post iTBS||||seconds||Standard Deviation|Mean
1463694|NCT00753506|Secondary|Change in Cognitive Functioning as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status and Change in Functional Performance as Measured by the UCSD Performance-based Skills Assessment.||10 weeks (weeks 2 & 12)|||||||
1463695|NCT00753506|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12|The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale. PANSS positive symptom scores and negative symptom scores each range from 7 to 49 units on a scale.|10 weeks (weeks 2 & 12)||||units on a scale||Standard Deviation|Mean
1463696|NCT00753454|Secondary|Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."|||units on a scale||Standard Deviation|Mean
1463697|NCT00753454|Secondary|Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit|Change from Baseline in Patient’s Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 140 are included in this analysis.~Data was not available for 28 subjects."|||units on a scale||Standard Deviation|Mean
1463698|NCT00753454|Secondary|Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit|MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
1463699|NCT00753454|Secondary|Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit|PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
1463728|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.|9 months|Intent to Treat population|||participants|||Number
1463700|NCT00753454|Secondary|Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1463701|NCT00753454|Secondary|Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1463702|NCT00753454|Secondary|Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1463703|NCT00753454|Secondary|Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1463704|NCT00753454|Secondary|Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 141 are included in this analysis.~Data was not available for 27 subjects."|||units on a scale||Standard Deviation|Mean
1463705|NCT00753454|Secondary|Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1463706|NCT00753454|Secondary|Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1463707|NCT00753454|Secondary|Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit|There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 143 are included in this analysis.~Data was not available for 25 subjects."|||units on a scale||Standard Deviation|Mean
1463708|NCT00753454|Secondary|Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit|Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is “No Fatigue” and 10 is “Fatigue as bad as you can imagine”) is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 139 are included in this analysis.~Data was not available for 29 subjects."|||units on a scale||Standard Deviation|Mean
1463729|NCT00753337|Secondary|All Cause Mortality|Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.|30 days|Intent to Treat population|||participants|||Number
1464645|NCT00744328|Secondary|Infant Development Among 6.5 Month Old Children of Mothers With PPMD, as Assessed by Bayley Scales of Infant Development||yearly|||||||
1463709|NCT00753454|Secondary|Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Thus, the mean also has a range from 0-3. Change from Baseline is computed as the value at Completion/Withdrawal minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."|||units on a scale||Standard Deviation|Mean
1463710|NCT00753454|Secondary|Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~The range for the CDAI is 0 - 76 with a lower CDAI score indicating improvement in activity and a higher score indicating a decline activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 152 are included in this analysis.~Data was not available for 16 subjects."|||percentage of subjects|||Number
1463711|NCT00753454|Secondary|Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~<= 3.3 (Remission), > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 151 are included in this analysis.~Data was not available for 17 subjects."|||percentage of subjects|||Number
1463712|NCT00753454|Secondary|Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI).~< 2.6 (Remission),~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 149 are included in this analysis.~Data was not available for 19 subjects."|||percentage of subjects|||Number
1463713|NCT00753454|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 146 are included in this analysis.~Data was not available for 22 subjects."|||units on a scale||Standard Deviation|Mean
1463714|NCT00753454|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm), and Investigator’s Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined where a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~<= 3.3 Remission, > 3.3 - <= 11 Low, > 11 - <= 26 Moderate, > 26 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 145 are included in this analysis.~Data was not available for 23 subjects."|||units on a scale||Standard Deviation|Mean
1463715|NCT00753454|Secondary|Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit|"DAS28(ESR) is calculated using the tender joint count (TJC), swollen joint count (SJC) erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.~< 2.6 Remission,~> = 2.6 - < =3.2 Low, > 3.2 - < = 5.1 Moderate, > 5.1 High."|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 142 are included in this analysis.~Data was not available for 26 subjects."|||units on a scale||Standard Deviation|Mean
1463716|NCT00753454|Secondary|Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit|ACR70 response is defined for subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
1499049|NCT00479258|Secondary|Slope From Baseline to Week 52 and Slope From Week 12 to Week 52 for FEV1 and FVC as a Percent of Predicted;||12 months|||||||
1463717|NCT00753454|Secondary|Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit|ACR50 response is defined for subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
1463718|NCT00753454|Secondary|Percentage of Subjects With ACR20 (American College of Rheumatology 20% Improvement) Response at Completion/Withdrawal Visit|ACR20 response is defined for subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity, 5) Physician's Global Assessment of Disease Activity.|Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks)|"Of the 168 subjects in the Full Analysis Set (FAS), 155 are included in this analysis.~Data was not available for 13 subjects."|||percentage of subjects|||Number
1463719|NCT00753454|Primary|Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period|"A Serious Adverse Event is any untoward medical occurrence that at any dose~results in death,~is life threatening,~requires in-patient hospitalization or prolongation of existing hospitalization,~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect"|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
1463720|NCT00753454|Primary|Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
1463721|NCT00753454|Primary|Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period|"A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.~A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).~TEAEs are all AEs in which the onset date and time is after the first study drug administration in C87084, up to 84 days after the last injection."|From Entry Visit up to approximately 60 weeks|Of the 168 subjects in the Full Analysis Set (FAS), 168 are included in this analysis.|||percentage of subjects|||Number
1463722|NCT00753415|Secondary|Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)|An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.|From pre-vaccination to Week 69|Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.||||||
1463723|NCT00753415|Primary|Number of Participants With Adverse Events (AEs)|This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|All Participants as Treated (APaT) population; all participants who received at least one vaccination.|||Participants|||Number
1463724|NCT00753415|Primary|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.|Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period|Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.|||Participants|||Number
1463725|NCT00753363|Secondary|Fitness|Maximal oxygen consumption (VO2max) on a treadmill|Baseline and 6 month||||L/min||Standard Error|Mean
1463726|NCT00753363|Secondary|Body Weight||Baseline and 6 month||||kg||Standard Error|Mean
1463727|NCT00753363|Primary|Insulin Sensitivity|Insulin resistance is defined as a reduction in glucose utilization rate elicited by a given insulin concentration. Glucose utilization is measured during a three hour hyperinsulinemic-euglycemic clamp and is presented as a measure of insulin sensitivity. This is one of the most sophisticated methods to measure insulin sensitivity.|Baseline and 6 month||||μmol/kgFFM/min||Standard Error|Mean
1499050|NCT00479258|Secondary|Change From Baseline in Other PFT Parameters||12 months|||||||
1463730|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|9 months|Intent to Treat population|||percentage of limbs|Participants||Number
1463731|NCT00753337|Secondary|Hemodynamic Success|Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.|30 days|Intent to Treat population|||percentage of limbs|Participants||Number
1463732|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|9 months|Intent to Treat population|||percentage of limbs|Participants||Number
1463733|NCT00753337|Secondary|Clinical Success|Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.|30 days|Intent to Treat population|||percentage of limbs|Participants||Number
1463734|NCT00753337|Secondary|Procedure Success|Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)|9 months|Intent to Treat population|||percentage of participants|||Number
1463735|NCT00753337|Secondary|Lesion Success|Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
1463736|NCT00753337|Secondary|Device Success|Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
1463737|NCT00753337|Secondary|Primary Patency Rate at 9 Months|Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.|9 months|Intent to Treat population|||percentage of lesions|Participants||Number
1463738|NCT00753337|Primary|Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).|Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.|9 months|Intent to Treat population (ITT)|||percentage of participants|||Number
1463739|NCT00753298|Primary|Subject's Sensation When Using Test Catheter|Subject's sensation when using test catheter, measured by mean score on a scale from 1 (Comfortable) to 6 (Severe pain)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1463740|NCT00753298|Primary|Subject's General Satisfaction With Test Catheter|Subject's general satisfaction with test catheter, measured by mean score on a scale from 1 (Very satisfied) to 5 (Absolutely not satified)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1463741|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter After Withdrawal|Subject's perception regarding handling of test catheter after withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1463742|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Withdrawal|Subject's perception regarding handling of test catheter at withdrawal, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1463743|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter at Insertion|Subject's perception regarding handling of test catheter at insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1463744|NCT00753298|Primary|Subject's Perception Regarding Handling of Test Catheter Before Insertion|Subject's perception regarding handling of test catheter before insertion, measured by mean score on a scale from 1 (Easy) to 5 (Troublesome)|At 4 weeks||||Score on scale||Standard Deviation|Mean
1463745|NCT00753272|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains|In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) ≥ 1:40 or a pre-vaccination HI titer (Day 0) ≥ 1:10 and fold-increase (post/pre) ≥ 4.|At Day 21 of the first year (2008/2009) of the study.|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.|||Participants|||Count of Participants
1463746|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the second year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1463756|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Days||Full Range|Mean
1506853|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years||Day 21||||ug/mL||Standard Deviation|Mean
1463747|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.|At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the first year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1463748|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study|The Two-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the second year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1463749|NCT00753272|Secondary|Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol cohort for immunogenicity included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 21 of the first year of the study.|||Titers||95% Confidence Interval|Geometric Mean
1463750|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1463751|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit|For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 180 days (Days 0-179) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1463752|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the second dose (Year 2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1463753|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.|Within 21 days (Days 0-20) after the first dose (Year 2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1463754|NCT00753272|Secondary|Number of Days With Any Grade of Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Days||Full Range|Mean
1463755|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1463757|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1463758|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Days||Full Range|Mean
1463759|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)|The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.|||Participants|||Count of Participants
1463760|NCT00753272|Secondary|Number of Days With Any Grade of Solicited Local Symptoms|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Days||Full Range|Mean
1463761|NCT00753272|Secondary|Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter|During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)|The One-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented during the first year of the study and included in the safety subset.|||Participants|||Count of Participants
1463762|NCT00753272|Secondary|Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).|"SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.~Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1463763|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
1463764|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)|The Two-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented in each year of the study|||Participants|||Count of Participants
1463765|NCT00753272|Secondary|Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).|"Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.~Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination"|Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)|The One-Dose Total Vaccinated cohort included all subjects with one vaccine administration documented during the first year of the study.|||Participants|||Count of Participants
1463766|NCT00753272|Secondary|Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine|Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
1463767|NCT00753272|Secondary|Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.|The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
1463768|NCT00753272|Secondary|Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.|"Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of ≥37.8 degrees Celsius) and cough.~The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v)."|During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)|The One-Dose According-To-Protocol cohort for efficacy for peak season included all subjects from the One-Dose ATP cohort for efficacy who did not drop out from the study before the start of their first influenza peak season.|||Participants|||Count of Participants
1463769|NCT00753272|Secondary|Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.|Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
1463770|NCT00753272|Secondary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)|The According-To-Protocol cohort for efficacy included all eligible subjects from the Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
1463771|NCT00753272|Primary|Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.|Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.|At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study|The One-Dose According-To-Protocol immunogenicity cohort for the lot-to-lot consistency subset, which included all subjects from the One-Dose ATP cohort for immunogenicity included in the lot-to-lot subset.|||Titers||95% Confidence Interval|Geometric Mean
1463772|NCT00753272|Primary|Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.|Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.|After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))|The One-Dose According-To-Protocol cohort for efficacy included eligible subjects from the One-Dose Total Vaccinated cohort (e.g. who complied with the protocol, with no elimination criteria assigned during the study), who had started their first surveillance period, who had not received a seasonal influenza vaccine not foreseen in the protocol.|||Participants|||Count of Participants
1463773|NCT00753220|Primary|Maximum Tolerated Dose (MTD)|"PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer.~ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD."|Up to 1 year||||intratumorally delivered cells|||Number
1463774|NCT00753142|Secondary|To Determine if Hyperglycemia-induced Reduced Insulin Secretion is the Result of Beta-cell Exhaustion or Beta-cell Desensitization.||4 years|||||||
1463775|NCT00753142|Primary|First Phase Insulin Release (FPIR)|Calculated as the sum of the insulin levels at 2, 3, 4, and 5 min after infusion|at the end of 20 hours||||microunits/ml||Standard Deviation|Mean
1463776|NCT00753012|Primary|Blood Pressure at Maximum Exertion|Diastolic blood pressure (DBP) at maximum exertion following 3-6 months of stimulant medication, according to cardiopulmonary exercise testing (CPET)|3-6 months||||mmHg||Standard Deviation|Mean
1463777|NCT00753012|Primary|Cardiac Function Index (E/A Ratio)|Left ventricle diastolic function index, following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months||||cm/sec/cm/sec||Standard Deviation|Mean
1499149|NCT00478140|Secondary|Disease Control Rate|Percentage of participants who have achieved complete response, partial response and stable disease|Up to 3.5 years|||||||
1463778|NCT00753012|Primary|Left Ventricle Size|Size of the heart's left ventricle chamber (Left Ventricular End Diastolic Dimension; LVEDD) following 3-6 months of stimulant medication, according to cardiac ultrasound (transthoracic echocardiogram; TTE)|3-6 months|14 subjects completed endpoint TTE; one HTN subject missed the scheduled endpoint TTE appointment.|||mm||Standard Deviation|Mean
1463779|NCT00752986|Secondary|Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes||Continuous assessment of safety.|||||||
1463780|NCT00752986|Secondary|Overall Survival||Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.|||||||
1463781|NCT00752986|Secondary|Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)||Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.|||||||
1463782|NCT00752986|Primary|Event Free Survival|Success rate (patients without progression and still on treatment at 24 weeks|Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.|||||||
1463783|NCT00752973|Secondary|Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions.|To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation.|Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments)|A total of 12 subjects were enrolled. All of them used the study drug for at least one dose of the treatment. At Day 0 the study drug was to be used. At Day 7 if subject presented with live lice they were provided a second treatment. The subjects may used it for 1 (for subjects not requiring retreatment) or 2 (for retreated subjects).|||participants|||Number
1463784|NCT00752973|Primary|Participants Clinically Cured of Head Lice 14 Days After Last Treatment|No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects).|Day 7±1 and Day 14 or Day 21|No statistical analysis provided for Clinical Cure|||participants cured of lice|||Number
1463785|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 24 hrs (Day 1)||||percentage of participants|||Number
1463786|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participants had wheezing as medical history which continued without increase in severity throughout the treatment."|at 1 hr (Day 0)||||percentage of participants|||Number
1463787|NCT00752973|Primary|Participants With the Clinical Evidence of Cholinesterase Inhibition|"Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.~Abnormal heart rate.~Diarrhea or abdominal cramps.~Inappropriate sweating.~Pupillary miosis (constriction).~Respiratory difficulty such as chest tightness or wheezing.~One participant had wheezing as medical history which continued without increase in severity throughout the treatment."|at Baseline||||percentage of participants|||Number
1463788|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day).|"Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent reduction = (Post treatment value – Baseline)/ Baseline x100."|Change from baseline to 24 hrs (1 day)|11 subjects with obtained blood sample. subject 01-004: At Visit 2, Day 1 Lab could not perform testing due to sample not suitable for testing. Because only 2ml blood was able to collected after multiple attempts.|||percentage change in cholinesterase||95% Confidence Interval|Mean
1463789|NCT00752973|Primary|Participants With a Change in Cholinesterase Level at 1 Hour (Day 0).|"Each patient (aged 6 – 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals.~If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines.~Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.~Mean percent change (reduction) = (Post treatment value – Baseline)/ Baseline x100."|Change from Baseline to 1 hour|"10 subjects with obtained blood sample. subject 01-003: Study coordinator was unable to obtain blood sample post treatment at Visit 1, Day 0.~subject 01-004: At Visit 1 Day 0 (post treatment), Blood sample could not be obtained even after two attempts."|||percentage change in cholinesterase||95% Confidence Interval|Mean
1463790|NCT00752895|Secondary|Number of Antibiotic Use Days|An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.|3 months|Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.|||days||Standard Deviation|Mean
1463804|NCT00752726|Secondary|Change From Baseline to Week 24 in Waist Circumference|Waist circumference was measured against the skin, without interference from clothing, at the level midway between the lateral lower rib margin and the iliac crest in standing position.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||cm||Standard Deviation|Mean
1463791|NCT00752895|Primary|Acute Respiratory Infection (ARI) Days|An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.|3 months|Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.|||days||Standard Deviation|Mean
1463792|NCT00752791|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 1-19) and Evaluation Period (Weeks 20-25). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 25|Safety Analysis Set. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.|||percentage of participants|||Number
1463793|NCT00752791|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 25 weeks.|Full analysis set where data was available for each time interval (indicated by N).|||percentage of participants||95% Confidence Interval|Number
1463794|NCT00752791|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 1-19) and weekly during the Evaluation Period (Weeks 20-25). One patient did not have central lab hemoglobin value during a regularly scheduled visit during weeks 2-5.|Up to 25 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).|||g/dL||Standard Deviation|Mean
1463795|NCT00752791|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 1 - 19) and Evaluation Period (Weeks 20 -25). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. One patient had the last study visit during the titration period and the transfusion after the titration period. This patient is excluded from the summary of evaluation period.|Up to 25 weeks.|Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
1463796|NCT00752791|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|Percentage of participants with a mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from measured at Weeks 20 to 25) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.|Baseline and Week 20 to Week 25.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
1463797|NCT00752791|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Week 20 to Week 25). The target hemoglobin range was 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 20 to Week 25.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
1463798|NCT00752791|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|The primary efficacy endpoint was the mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to Enrollment and the hemoglobin on the day of Enrollment) and the Evaluation Period (mean hemoglobin from Weeks 20 to 25).|Baseline and Week 20 to Week 25.|The Full Analysis Set included all patients who received at least 1 dose of peginesatide injection and where data was available at both time points (indicated by N).|||g/dL||Standard Deviation|Mean
1463799|NCT00752726|Secondary|Selectivity Index at Week 24|The selectivity index (SI) was used as a measure of orlistat’s ability to target abdominal VAT loss compared to total adipose tissue lost. SI was calculated using the following equation: Mean % change in VAT divided by Mean % change in total fat mass.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment, only in Orlistat 60 mg group. This analysis was not carried out for placebo group.|||Ratio|||Number
1463800|NCT00752726|Secondary|Change From Baseline to Week 24 in Quality of Life (QoL) Scores.|QoL scores were measured using an Impact of Weight Quality of Life (IWQoL) Questionnaire, which scored the responses at a scale of 1 to 5(1, never true, to 5, always true): QoL scales for physical function, self-esteem, sexual life, public distress, and work were evaluated, and summarized in a total score. A higher value indicated a better quality of life.|Baseline to week 24|This analysis was carried out for the observed ITT population, i.e. ITT subjects who had this post-baseline efficacy assessment.|||Score on a Scale||Standard Deviation|Mean
1463801|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Calories Expended for Physical Activity|Measurement of physical activity from Paffenbarger questionnaire. The number of caloried expended was representation of activity level: Higher calorie counts indicate higher activity|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Kilocalorie (kcal)/week||Standard Deviation|Mean
1463802|NCT00752726|Secondary|Change From Baseline to Week 24 in Liver Fat|The liver fat was measured by CT scan in Hounsfield Units (HU).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Hounsfield Units (HU)||Standard Deviation|Mean
1463803|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Liver Fat|For Liver fat, Intrahepatic lipids (IHL) were measured by Magnetic Resonance Spectroscopy (MRS).|Baseline to week 24|ITT subset (participants who had this post-baseline efficacy assessment) from one study site was analysed for this parameter.|||Percentage (%) IHL||Standard Deviation|Mean
1463805|NCT00752726|Secondary|Change From Baseline to Week 24 in Percentage Body Fat|Body fat was assessed through Bioelectrical Impedance Analysis (BIA).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||Percentage (%) body fat||Standard Deviation|Mean
1463806|NCT00752726|Secondary|Change From Baseline to Week 24 in Total Fat Mass|Change in total fat mass was calculated from an average of three measurements at each visit from Echo Magnetic Resonance Imaging (EchoMRI).|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1463807|NCT00752726|Secondary|Change From Baseline to Week 24 in Body Weight|Participants were weighed at least twice until two consecutive measurements were within 0.5 kg of each other and the average of the two measurements was recorded.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1463808|NCT00752726|Secondary|Change From Baseline to Week 12 in Abdominal VAT Mass|Abdominal VAT mass from baseline to week 12 was measured by CT scan.|Baseline to week 12|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1463809|NCT00752726|Primary|Change From Baseline to Week 24 in Abdominal VAT Mass|VAT was measured by the computed tomography (CT) scan.|Baseline to week 24|This analysis was carried out for the observed ITT population, who had this post-baseline efficacy assessment.|||kg||Standard Deviation|Mean
1463810|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission Off Steroids in the Interventional Phase|"Number of participants who were in clinical remission and off systemic corticosteroids at visit.~The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1463811|NCT00752622|Secondary|Number of Participants Who Had Clinical Remission in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical remission was defined as CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase."|Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1463812|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI-100 at Weeks 14-16, 24 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 100-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at weeks 14-16, 24 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16, 24 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1463813|NCT00752622|Secondary|Number of Participants Who Had a Clinical Response Using the CDAI at Weeks 14-16 and 48 in the Interventional Phase|"The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill.~Clinical response was defined as a 70-point reduction in CDAI score from randomization into the interventional phase or CDAI < 150 at week 14-16 and 48 in the Interventional Phase. Baseline is value at randomization."|Baseline and Weeks 14-16 and 48 in the Interventional Phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1463814|NCT00752622|Secondary|Number of Participants That Required Treatment Optimization in the Observational Phase|"Participants required treatment-optimization if:~Disease progression/lack of response after entering observational phase; or~Participant was successfully randomized into the interventional phase~The definition of loss of response was as follows:~- An increased HBI score >= 3 points over the week 10 evaluation score and a CDAI score >= 175.~Despite:~having received regular infusions of infliximab every 8 weeks during the observational phase with a maximum interval of no > 10 weeks between each infusion, and~having received previous doses of infliximab of >= 4.7 mg/kg."|Week 54 in the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication. Of the 98 participants in the ELIG population, 65 participants entered the observational phase.|||Participants|||Number
1463815|NCT00752622|Primary|Mean Change From Baseline in Harvey-Bradshaw Index (HBI)|Mean change in HBI score from Baseline to Week 10, 30, and 54. HBI score consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is the sum of individual parameters. Minimum score is 0 and no pre-specified maximum score as it depends on the number of liquid stools. Lower scores indicate better well being. Clinical response/ long-term response is defined as a decrease by 3 or more points from baseline value. Loss of response is defined as an increase of >= 3 points.|Baseline and Evaluation Week 10, Week 30 and Week 54 of the Observational Phase|The eligible (ELIG) population comprised a subset of the enrolled (ENR) population who were not associated with an important protocol violation and who received at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
1463816|NCT00752622|Primary|Number of Participants Who Had a Clinical Response Using the Crohn's Disease Activity Index (CDAI) at Week 24 in the Interventional Phase|The CDAI incorporates 8 items that are indicators of disease severity. Scores range from 0 to ~600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. Participants provided completed CDAI diary cards and were considered as responders in the interventional phase if their CDAI score at week 24 was decreased by 70 points or greater over their CDAI score at randomization into the interventional phase, or if their week 24 CDAI score is <= 150. Baseline is value at randomization.|Baseline and Week 24 of the Interventional phase|Due to the early termination of the study, no participants completed the Interventional phase.||||||
1463817|NCT00752609|Secondary|Percentage of Participants With Dose Adjustments During the Study|The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was >20% higher or >20% lower respectively, than the previous dose.|From Week 4 to Week 20|Safety Analysis set, which included all patients who received at least 1 dose of study drug. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.|||percentage of participants|||Number
1463818|NCT00752609|Secondary|Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals.|Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full analysis set where data was available for each time interval (indicated by N).|||percentage of participants||95% Confidence Interval|Number
1463819|NCT00752609|Secondary|Mean Hemoglobin During 4-week Intervals|Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24).|Up to 24 weeks.|Full Analysis Set where data was available for each time interval (indicated by N).|||g/dL||Standard Deviation|Mean
1463820|NCT00752609|Secondary|Percentage of Participants With Red Blood Cell Transfusions|The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.|Up to 24 weeks.|Full Analysis Set.|||percentage of participants||95% Confidence Interval|Number
1463821|NCT00752609|Secondary|Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL|"Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Baseline and Week 19 to Week 24.|Full analysis set where data was available.|||percentage of participants||95% Confidence Interval|Number
1463822|NCT00752609|Secondary|Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period|"Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL.~The 95% confidence interval was calculated from the normal approximation with continuity correction."|Week 19 to Week 24|Full Analysis Set where data was available.|||percentage of participants||95% Confidence Interval|Number
1463823|NCT00752609|Primary|Mean Change in Hemoglobin Between Baseline and the Evaluation Period|Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).|Baseline and Week 19 to Week 24.|The Full Analysis Set including all patients who received at least 1 dose of study drug where data was available (indicated by N).|||g/dL||Standard Deviation|Mean
1463824|NCT00752232|Other Pre-specified|The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.|The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1463825|NCT00752232|Other Pre-specified|The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Z-score||Standard Deviation|Mean
1463826|NCT00752232|Other Pre-specified|The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1463855|NCT00751998|Primary|Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.||During Procedure||||percent||95% Confidence Interval|Number
1468014|NCT00721188|Primary|Terminal Phase Elimination Rate Constant (λz)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||1/hour||Standard Deviation|Mean
1463827|NCT00752232|Other Pre-specified|The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.|The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.|Baseline up to 24 months|Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).|||Units on a scale||Standard Deviation|Mean
1463828|NCT00752232|Secondary|Anti-a-beta IgM Titer at Specified Visits|Geometric mean of anti-a-beta IgM titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
1463829|NCT00752232|Secondary|Anti-a-beta IgG Titer at Specified Visits|Geometric mean of anti-a-beta IgG titer from pre-study through Week 104|Baseline up to 24 months|The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.|||Units/mL||95% Confidence Interval|Geometric Mean
1463830|NCT00752232|Primary|Number of Participants With Abnormalities in Neurological Examination|Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1463831|NCT00752232|Primary|Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data|Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1463832|NCT00752232|Primary|Incidence of Treatment-emergent Adverse Events (AEs) by Severity|Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)|Baseline up to 24 months|The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.|||Participants|||Number
1463833|NCT00752219|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
1463834|NCT00752219|Secondary|Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
1463835|NCT00752219|Secondary|Number of Participants With Clinical Response in CE Participants at the End of IV Therapy|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|End of IV therapy: From Day 5 to Day 14|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
1463836|NCT00752219|Secondary|Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required.|Test of cure visit: 2 weeks post-therapy (Day 28)|CE population included all randomized participants diagnosed with intraperitoneal infection confirmed by operative findings, received adequate therapy and had information to determine clinical outcome at specified visit.|||participants|||Number
1463837|NCT00752219|Secondary|Number of Participants With Microbiological Response at the Late Follow-up Visit|Favorable: eradication (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication (absence of material to culture in a patient who had responded clinically to treatment)|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1463890|NCT00751634|Primary|Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care|Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.|baseline, one, two and six hours after application.||||degrees F||Standard Deviation|Mean
1463838|NCT00752219|Secondary|Number of Participants With Microbiological Response at the End of IV Therapy|Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.|End of IV therapy: From Day 5 to Day 14|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1463839|NCT00752219|Secondary|Number of Participants With Microbiological Response at the Test of Cure Visit|Microbiological response was defined as eradication of pathogen identified (absence of causative pathogens from appropriately obtained specimens at site of infection) or presumptive eradication of pathogens (absence of material to culture in a participant who had responded clinically to treatment). This clinical response was measured in participants who were ME at baseline.|Test of cure visit: 2 weeks post-therapy (Day 28)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1463840|NCT00752219|Secondary|Number of Participants With Clinical Response at the Late Follow-up Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.|Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks)|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1463841|NCT00752219|Secondary|Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were ME at baseline.|End of IV therapy: From Day 5 to Day 14|ME population: A subset of CE population with at least 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents.|||participants|||Number
1463842|NCT00752219|Primary|Number of Participants With Clinical Response at the Test of Cure (TOC) Visit|Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.|Test of cure visit: 2 weeks post-therapy (Day 28)|ME set:clinically evaluable(CE)subset with atleast 1 etiologic pathogen isolated from a clinically relevant specimen in initial culture susceptible in both study agents. CE set:participants diagnosed with intraperitoneal infection confirmed by operative findings with adequate therapy and information to determine clinical outcome at specified visit.|||participants|||Number
1463843|NCT00752128|Secondary|Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition||12 Months|Intention to treat|||percentage of participants|||Number
1463844|NCT00752128|Primary|Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)||12 Months|Analysis per intention to treat|||percentage of participants|||Number
1463845|NCT00752102|Primary|Coronary Artery (CAC) Score Progression|"coronary artery (CAC) score difference between baseline and followup CT scans. It was measured in Agatston units. These are units of amount of calcification in the blood vessels so it's a continuous variable. The amount of calcium was quantified with the Agatston scoring method. Calcium scores were adjusted with a standard calcium phantom that was scanned along with the participant. The phantom contained known calcium density bars and provided a way to calibrate the x-ray attenuation level.~Participants scoring CAC >400 are considered to be at risk for having at least one coronary lesion."|48 weeks||||Agatston units||Standard Deviation|Mean
1463846|NCT00752089|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"PP population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."|||ug*F/cm^3||95% Confidence Interval|Least Squares Mean
1463847|NCT00752089|Primary|Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Per-Protocol (PP) population: All randomized participants who received at least one dose of study product, had at least one post-baseline efficacy assessments and no major protocol deviations. Missing data was not imputed. Due to drop-outs, there were differences in the n per treatment group."|||% SMHR||95% Confidence Interval|Least Squares Mean
1463848|NCT00751998|Secondary|Health Resources Utilization (Health Economics)||Procedure through end of study.|||||||
1463849|NCT00751998|Secondary|Device Durability and Device Performance.||Procedure|||||||
1463850|NCT00751998|Secondary|Safety||Procedural through end of study|||||||
1463851|NCT00751998|Secondary|Sensitivity of SpyBite Biopsy Forceps in Malignant Strictures.||Post Procedure|||||||
1463852|NCT00751998|Secondary|Ability to Visualize and Access Various Targeted Anatomic Areas.||Procedure|||||||
1463853|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Subject Management.||Procedure or at 12 months|||||||
1463854|NCT00751998|Secondary|Impact of SpyGlass DVS Cholangioscopy With or Without Biopsy on Diagnosis.||Procedural through end of study|||||||
1463856|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by EuroQoL EQ-5D|"The EQ-5D is a standardized instrument for use as a generic measure of the quality of health-related life and of health outcome.~The EuroQoL EQ-5D is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.~Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL|||units on a EuroQol EQ-5D scale||Standard Deviation|Mean
1463857|NCT00751972|Secondary|Change in Distance Walked in the 6-minute Walk Test Between Baseline and 180 Days|"The 6MWT is a simple test which does not require expensive equipment or advanced training for technicians. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. The patient can stop or slow down at any time and then resume walking, depending on his/her degree of fatigue.~A longer distance walked is indicative of a better outcome."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of 6 minute walk distance.|||meters||Standard Deviation|Mean
1463858|NCT00751972|Secondary|Quality of Life Change From Baseline to 180 Days, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|"KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQ’s questions are used to calculate scores in ten domains:~Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall Summary: a combined measure of all the above~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Baseline and 180 Days|Number of participants with both baseline and 180 day data were used for this analysis of QOL.|||units on a KCCQ scale||Standard Deviation|Mean
1463859|NCT00751972|Secondary|Incidence of All Device Failures and Device Malfunctions|The INTERMACS event device malfunction defined a failure of the HeartWare VAS as either pump failure or non-pump failure.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Number of events|||Number
1463860|NCT00751972|Secondary|Incidence of Adverse Events, Neurocognitive Status and Unanticipated Adverse Device Effects|Adverse events are only provided for patients who received a HeartWare Ventricular Assist Device (HeartWare® VAS). Adverse events as described by INTERMACS for the contemporaneous control population were not a part of the agreement for analysis and thus not provided by INTERMACS, and so not included in the Adverse Event Module and relevant Outcome Measures for comparison.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||percentage of patients|||Number
1463861|NCT00751972|Secondary|Survival to 180 Days|All subjects will be followed for date of death until 180 days.|180 Days|The secondary effectiveness analyses were performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Percentage of participants with survival|||Number
1463862|NCT00751972|Primary|The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful.|The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.|180 days|The primary effectiveness analyses was performed on the safety population, consisting of all enrolled subjects who received a Ventricular Assist Device (VAD).|||Percentage of participants with success|||Number
1463863|NCT00751933|Secondary|Symptom Score Improvement of 2 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months|||||||
1463864|NCT00751933|Primary|Symptom Score Improvement of 3 or More During or After 6 Months|No patient completed the study, therefore we have no information to report.|6 months|||||||
1463865|NCT00751881|Other Pre-specified|Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)|"PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.~Hepatic parameters thresholds were defined as follows:~Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);~Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;~Alkaline Phosphatase >1.5 ULN;~Total Bilirubin (TB) >1.5 or 2 ULN;~ALT >3 ULN and TB >2 ULN."|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."|||participants|||Number
1463874|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in EDSS Total Score|"EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation.~EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).~Baseline adjusted least-squares means at Week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on EDSS score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24, Week 36 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1506854|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years||Day 21||||ug/mL||Standard Deviation|Mean
1463866|NCT00751881|Secondary|Extension Treatment Period: ARR: Poisson Regression Estimate|"ARR was obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations. A relapse is defined as the appearance of a new clinical sign/symptom or clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persists for a minimum of 24 hours in the absence of fever. Relapse was confirmed by an increase in EDSS score or Functional System scores. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrolment and baseline EDSS stratum as covariates)."|Extension treatment period (Maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.|||relapses per year||95% Confidence Interval|Number
1463867|NCT00751881|Secondary|Extension Treatment Period: Time to Disability Progression|"Probability of disability progression since the randomization of the core period was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12 week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event free for the amount of time t. Probability of event at time t was 1 minus the probability of being event-free for the amount of time t."|Core treatment period (maximum: 173 weeks) and Extension treatment period (maximum: 174 weeks)|ITT population for extension treatment period consists of all participants with a signed informed consent form for the extension and with a date of treatment allocated or recorded in the IVRS/IWRS database, regardless of whether the treatment was actually taken.|||percent probability||95% Confidence Interval|Number
1463868|NCT00751881|Secondary|Extension Treatment Period: Overview of Treatment Emergent Adverse Events (TEAE)|AEs were any unfavourable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first intake of study drug in extension treatment period up to 28 days after the last intake in the extension treatment period|"Safety population: all randomized participants who received at least 1 dose of investigational product.~Two participants in placebo of core study received teriflunomide and were analyzed according to teriflunomide dose.~One participant in teriflunomide 14 mg in core study group who received 7 mg was analyzed in teriflunomide 7 mg group."|||participants|||Number
1463869|NCT00751881|Secondary|Core Treatment Period: Overview of Adverse Events|Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.|From first study drug intake up to 112 days after last intake in the core treatment period or up to first intake in the extension treatment period, whichever occurred first|"All randomized and treated participants. Participants were considered according to the drug actually received.~The 3 participants in the placebo group who received teriflunomide were analyzed according to the teriflunomide dose.~The participant in the teriflunomide 14 mg group who received 7 mg was analyzed in the teriflunomide 7 mg group."|||participants|||Number
1463870|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for each summary score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1463871|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Short Form Generic Health Survey - 36 Items (SF-36) Summary Scores|"SF-36 scale is a generic, self-administered, health-related quality-of-life (QOL) instrument. It is constructed such that the 36 questions represent 8 of the most important health concepts: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.~Two summary scores are obtained:~the physical health component summary score,~the mental health component summary score.~Both scores range from 0 to 100 and a high score indicates a more favorable health state.~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures [MMRM] on each summary score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1463872|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Last Visit in Fatigue Impact Scale (FIS) Total Score|Baseline adjusted least-squares means at last visit were estimated using an analysis of covariance (ANCOVA) model on collected data for FIS total score (treatment group, region of enrollment, baseline EDSS stratum, visit number for the last visit and baseline value as factors).|Baseline (before randomization) and up to Week 152|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1463873|NCT00751881|Secondary|Core Treatment Period: Change From Baseline to Week 48 in Fatigue Impact Scale (FIS) Total Score|"FIS is a participants-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in 3 areas; physical, cognitive, and social.~FIS total score ranges from 0 (no problem) to 160 (extreme problem).~Baseline adjusted least-squares means at week 48 were estimated using a Mixed-effect model with repeated measures (MMRM) on FIS total score data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value, and baseline-by-visit interaction as factors). All the timepoints from randomization up to Week 48 were included in the model."|Baseline (before randomization), Week 12, Week 24 and Week 48|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
1465562|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 42||Baseline and week 42|Treated Set with values for HbA1c at baseline and week 42. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1463875|NCT00751881|Secondary|Core Treatment Period: Time Without Relapse|"Probability of no relapse at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to relapse defined as the time from randomization to first EDSS confirmed relapse.~Participants free of confirmed relapse (no EDSS confirmed relapse observed on treatment) were censored at the date of the last study drug intake."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population|||percent probability||95% Confidence Interval|Number
1463876|NCT00751881|Secondary|Core Treatment Period: Time to Disability Progression|"Probability of disability progression at 24, 48, 108 and 132 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first 12-week sustained disability progression [i.e. increase from baseline of at least 1 point in EDSS score (at least 0.5 point for participants with baseline EDSS score >5.5) that persisted for at least 12 weeks].~Participants free of disability progression (no disability progression observed on treatment) were censored at the date of the last on-treatment EDSS evaluation.~Kaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population|||percent probability||95% Confidence Interval|Number
1463877|NCT00751881|Primary|Core Treatment Period: Annualized Relapse Rate (ARR): Poisson Regression Estimate|"ARR is obtained from the total number of confirmed relapses that occurred during the treatment period divided by the sum of treatment durations.~Each episode of relapse - appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever - was to be confirmed by an increase in Expanded Disability Status Scale (EDSS) score or Functional System scores.~To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses as response variable; log-transformed treatment duration as offset variable; treatment group, region of enrollment and baseline EDSS stratum as covariates)."|Core treatment period between 48 - 152 weeks depending on time of enrollment|Intent-to-treat population: all randomized and treated participants. Participants were considered in the treatment group to which they were randomized regardless of the drug they actually received.|||relapses per year||95% Confidence Interval|Number
1463878|NCT00751790|Secondary|LH Increase|% of patients showing ≤1.0 IU/L increase in s-LH from 0 to 2 h after 1st & 2nd injection.% changes in PSA throughout treatment.% of 60 pts with s-testosterone levels >1.735 nmol/L after 2nd injection.Testosterone PD and triptorelin PK metrics in 15 pts|day 1 and day 169|||||||
1463879|NCT00751790|Primary|Achievement of Castration and Maintenance of Castration|Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).|at Day 29||||percentage of enrolled patients|||Number
1463880|NCT00751777|Primary|Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|"Definition of SCR:~Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline~Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline"|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||percentage of participants||95% Confidence Interval|Number
1463881|NCT00751777|Primary|Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo|GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.|Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||ratio||95% Confidence Interval|Number
1463882|NCT00751777|Secondary|Evaluation of Duration of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group||13 months|||||||
1463883|NCT00751777|Secondary|Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear||1 month|||||||
1463884|NCT00751777|Secondary|Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch||7 months|||||||
1463885|NCT00751777|Primary|Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo||Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194|Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.|||geometric mean titer||95% Confidence Interval|Geometric Mean
1463886|NCT00751634|Secondary|Number of Participants With Arrhythmia|New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm|Six hours||||participants|||Number
1463887|NCT00751634|Secondary|Number of Participants With Hypotension|New systolic blood pressure < 100 mm Hg, or new vasopressor use during study period|six hours||||participants|||Number
1463888|NCT00751634|Secondary|Number of Participants With Severe Shivering|"Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall~Mild: shivering localized to the neck and/or thorax only~Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax)~Severe: shivering involves gross movements of the trunk and upper and lower extremities"|six hours|All participants were analyzed for the outcome of BSAS=3|||participants|||Number
1463889|NCT00751634|Secondary|Time From Start of Cooling Device to Core Temperature < 100.4F|For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was <100.4F|Six hours||||hours||Standard Deviation|Mean
1464333|NCT00747149|Secondary|Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio||6 and 12 Weeks|||||||
1463891|NCT00751621|Secondary|Rate, Severity and Relatedness of Any Adverse Events (AEs) Per Infusion|The rate of AEs was the number of AEs over the number of infusions administered. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period.|||AEs per infusion|Participants||Number
1463892|NCT00751621|Secondary|Clinically Significant Abnormal Changes in Routine Laboratory Parameters Between Baseline and the Completion Visit.|The total number of subjects with clinically significant abnormal changes in routine laboratory parameters between baseline and the completion visit. Routine laboratory parameters included haematology, serum chemistry and urinalysis.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom laboratory parameter data was collected at both baseline and completion.|||participants|||Number
1463893|NCT00751621|Secondary|Clinically Relevant Changes in Vital Signs From Baseline to the Completion Visit.|The total number of subjects with clinically relevant changes in vital signs from baseline to the completion visit. Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|At baseline (data either from Infusion 40 or the completion visit of study ZLB06_001CR), and at completion (up to 42 months).|The AT safety data set (which comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available) and for whom vital signs data was collected at both baseline and completion.|||participants|||Number
1463894|NCT00751621|Secondary|Health Related Quality of Life (Short Form 36 Health Survey)|The Short Form 36 Health Survey (SF-36) is a 36-item questionnaire that measures generic health concepts that are relevant across age, disease, and treatment groups. The questions are grouped into eight domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100, with higher scores indicating a better health state.|At baseline and at the last available post-baseline observation for each subject (up to 42 months)|The analysis population comprised the Full-Analysis health related quality of life (HRQL) data set (defined as all subjects entered into the study who complete a baseline and at least 1 follow-up HRQL assessment), who were at least 15 years of age.|||score on a scale||Full Range|Median
1463895|NCT00751621|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
1463896|NCT00751621|Secondary|Number of Days of Hospitalization Due to Infections|Total number of days of hospitalization due to infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days|||Number
1463897|NCT00751621|Secondary|Annualized Rate of Hospitalization Due to Infections|The annualized rate was based on the total number of days of hospitalization due to infections and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
1463898|NCT00751621|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|Total number of days out of work / school / kindergarten / day care or unable to perform normal activities due to infections, for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days|||Number
1463899|NCT00751621|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Activities Due to Infections|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject diary days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||days per subject year|Participants||Number
1463900|NCT00751621|Secondary|Number of Infection Episodes|Total number of infections for the specified analysis population|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||infection episodes|||Number
1463901|NCT00751621|Secondary|Annualized Rate of Infection Episodes|The annualized rate was based on the total number of infection episodes occurring during the study divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||infection episodes per subject year|Participants|95% Confidence Interval|Number
1464003|NCT00750373|Primary|Number of Participants With In-hospital Death or Clinical Embolic Events|The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.|within 6 weeks from the randomization|intention to treat analysis|||participants|||Number
1463902|NCT00751621|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|"The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Potential SBIs included bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by the Medical Monitor and Investigator to determine if the event fulfilled the predefined criteria for SBIs."|Up to 42 months|The AT safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the ITT data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||SBIs per subject year|Participants||Number
1463903|NCT00751621|Primary|Total Serum IgG Trough Levels|The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics.|Up to 42 months|The “all treated” (AT) safety data set comprised all subjects treated with IgPro20 during any study period and was identical to the “Full Analysis/intention-to-treat” (ITT) data set that comprised all subjects treated with IgPro20 and for whom any efficacy data was available.|||g/L||Standard Deviation|Mean
1463904|NCT00751530|Secondary|Percentage of Participants Using Etravirine in Background Regimen|These results report the percent of participants using Etravirine in the background regimen.|Background regimen (no specific time frame)||||Percentage of Participants|||Number
1463905|NCT00751530|Primary|Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 Weeks||||Percentage of Participants|||Number
1463906|NCT00751530|Secondary|Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)|The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.|Baseline||||score||Full Range|Mean
1463907|NCT00751530|Secondary|CD4 Cell Changes Among Participants in PI vs Non-PI Group|CD4 cell counts were measured using standard of care testing via local laboratories.|baseline to 24 Weeks||||cells/mm3||Full Range|Mean
1463908|NCT00751530|Secondary|Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12|The HIV RNA (viral load) was measured using standard of care testing via local laboratories.|12 weeks||||Percentage of participants|||Number
1463909|NCT00751400|Secondary|Number of Dosing Occasions Per Subject That Exceeded 660 mg|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions||Standard Deviation|Mean
1463910|NCT00751400|Secondary|Number of Total Dosing Occasions Per Subject|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions||Standard Deviation|Mean
1463911|NCT00751400|Secondary|Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days|This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing|1 month|number of subjects reporting at least one tablet taken at any point during study|||participants|||Number
1463912|NCT00751400|Secondary|Average Daily Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||mg||Standard Deviation|Mean
1463913|NCT00751400|Secondary|Number of Subjects With and Without More Than 660 mg at Least Once|This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
1463914|NCT00751400|Secondary|Number of Subjects With and Without Next Dose Less Than 22 Hours Later|This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
1463915|NCT00751400|Secondary|Number of Subjects With and Without More Than One Tablet Taken Per Dose||1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||participants|||Number
1463916|NCT00751400|Secondary|Use Days With and Without Next Dose Less Than 22 Hours Later|Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||days|||Number
1464026|NCT00750191|Other Pre-specified|Opioid Usage|Patient reported Opioid usage (converted to morphine equivalents)|6 months||||mg||Standard Deviation|Mean
1464027|NCT00750191|Secondary|Disability|Disability as measured by the Oswestry Disability Index. Scale range: 0 (minimum: best outcome) to 100 (maximum: worst outcome)|6 months||||units on a scale||Standard Deviation|Mean
1463917|NCT00751400|Secondary|Dosing Occasions With One and More Than One Tablet Taken|Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||dosing occasions|||Number
1463918|NCT00751400|Primary|Use Days With One or More Misuse Occasions|Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.|1 month|Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days|||days|||Number
1463919|NCT00751348|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (from Day 0 up to Day 43 or Day 57)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1463920|NCT00751348|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
1463921|NCT00751348|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.|||Participants|||Count of Participants
1463922|NCT00751348|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptoms sheet filled in.|||Participants|||Count of Participants
1463923|NCT00751348|Secondary|Antibody Titers Against Varicela Viruses|Antibody titers were presented as geometric mean titers (GMTs).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Titers||95% Confidence Interval|Geometric Mean
1463924|NCT00751348|Secondary|Antibody Concentrations Against Rubella|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||IU/mL||95% Confidence Interval|Geometric Mean
1463925|NCT00751348|Secondary|Antibody Concentrations Against Mumps|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||U/mL||95% Confidence Interval|Geometric Mean
1463926|NCT00751348|Secondary|Antibody Concentrations Against Measles|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|At 42-days post-vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
1463927|NCT00751348|Primary|Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values|Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.|At 42 days post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.|||Participants|||Count of Participants
1464028|NCT00750191|Secondary|Pain|Pain level as measured by the Numerical Rating Scale. Scale range: 0 (minimum: best outcome) to 10 (maximum: worse outcome)|6 months||||units on a scale||Standard Deviation|Mean
1463928|NCT00751296|Secondary|Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).|Assess the time to disease progression and overall survival. (Progressive disease is defined as at least one of the following: more than or equal to 50% increase in the sum of the products of the greatest diameters of at least 2 lymph nodes on 2 consecutive determinations 2 weeks apart (at least one node must be ≥ 2 cm) or new palpable lymph nodes, more than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the costal margin or appearance of palpable hepatomegaly or splenomegaly not previously present, more than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5.0 x109/L, OR transformation to a more aggressive histology (e.g. Richter’s syndrome or prolymphocytic leukemia with >55% prolymphocytes)).|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.||||percentage of participants||95% Confidence Interval|Number
1463929|NCT00751296|Primary|To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)|"The primary endpoint was objective response to lenalidomide (Complete response +Partial response) evaluated as per the revised 1996 National Cancer Institute Working Group Guidelines.~Complete response: absence of lymphadenopathy and organomegaly by physical exam and radiology, absence of constitutional symptoms, normal CBC. Bone marrow to be done 2 months after the above criteria are met, must be normocellular, with <30% lymphocytes.~Partial Response: ≥ 50% decrease in the peripheral blood lymphocytes from pre-treatment value, ≥ 50% reduction in lymphadenopathy and organomegaly by physical exam or on CT scan. one or more of the following: neutrophils ≥ 1.5 x109/L, platelets > 100 x109/L or 50% improvement over baseline, hemoglobin > 110 g/L or 50% improvement over baseline (without transfusion)."|Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis.|Severe toxicities were seen in the first two patients enrolled on the initial protocol. The study was halted and the protocol amended to use a starting dose of lenalidomide 2.5 mg with monthly escalations to a target dose of 10 mg, extended tumor lysis prophylaxis and monitoring. 25 response evaluable patients were enrolled on the amended protocol.|||participants|||Number
1463930|NCT00751179|Secondary|Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until recovery of T1 of 90% of baseline and full recovery of neuromuscular function occurred as determined by the anesthesiologist as per routine clinical practice.|Start of administration of succinylcholine to recovery from neuromuscular blockade (Up to approximately 18 minutes)|Participants who received succinylcholine and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.|||Minutes||95% Confidence Interval|Geometric Mean
1463931|NCT00751179|Secondary|Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|Start of administration of sugammadex to recovery from neuromuscular blockade (Up to approximately 6 minutes)|Participants who received both rocuronium and sugammadex and had evaluable neuromuscular function data determined to be reliable by a central independent adjudication committee.|||Minutes||95% Confidence Interval|Geometric Mean
1463932|NCT00751179|Secondary|Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups|"Only AEs which occurred following administration of sugammadex or succinylcholine are included. AEs in the rocuronium - sugammadex group occurring after rocuronium but before sugammadex administration are considered pretreatment events and are not included. The AE reporting interval included the entire intubation/surgical period for the succinylcholine group (since succinylcholine was administered just prior to intubation/commencement of surgery) but not for the rocuronium - sugammadex group (since sugammadex was administered at the end of the surgical procedure)."|Up to 7 days post dose|Participants who received sugammadex or succinylcholine.|||participants|||Number
1463933|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463934|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463944|NCT00751114|Secondary|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)|||participants|||Number
1463935|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 15 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 15 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 15 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463936|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463937|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 10 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 10 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 10 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463938|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium dose. Only data post sugammadex dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received sugammadex with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463939|NCT00751179|Secondary|Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 2 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 2 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 2 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463940|NCT00751179|Primary|Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine|"Change from baseline = 5 minutes post dose value - baseline value. Baseline levels were obtained prior to rocuronium or succinylcholine dose. Only data post rocuronium dose are included for rocuronium - sugammadex group. The change from baseline interval included most or all of the intubation/surgical period for sugammadex analysis (since sugammadex was administered at the end of the surgical procedure) but not for succinylcholine or rocuronium analyses (since these were administered immediately after the baseline measurement just prior to intubation/commencement of the surgical period)."|Baseline and 5 minutes post dose|Participants who received rocuronium or succinylcholine with evaluable (i.e., not missing or hemolyzed) blood samples for potassium measurement at baseline and at the 5 minute post-dose time point.|||mmol/L||Standard Deviation|Mean
1463941|NCT00751140|Secondary|Surgical Outcomes: Mean Lymph Node Count|The mean (range) total lymph node count and lymph node count per procedure category. Between 2009 and 2011, patients with suspected upper urinary tract urothelial carcinoma (UUT-UC) underwent open, laparoscopic, or robot-assisted radical nephroureterectomy (RNU) with modified retroperitoneal lymph node dissection (RPLND).|2 years|Total Participants and Participants Per Procedure Category|||Lymph Nodes||Full Range|Mean
1463942|NCT00751140|Primary|Number of Participants With Pathologically Proven Lymph Node Metastasis|"The number of participants having pathologically proven lymph node metastasis at the time of radical nephroureterectomy (RNU) and modified retroperitoneal lymph node dissection (RPLND).~The primary endpoint is the detection via lymph node dissection of pathological node positive urothelial carcinoma in patients treated with open or laparoscopic nephroureterectomy for upper tract urothelial cancer."|Up to 4 years|All evaluable participants. On histopathological review, one patient had a benign angioma and was excluded from the final data analysis.|||participants|||Number
1463943|NCT00751114|Secondary|Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration|During the treatment phase (24 weeks) plus 7 days after last dose|The population analyzed for this outcome measure was the safety population (treated patients)|||participants|||Number
1463945|NCT00751114|Secondary|Change in Body Weight From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||kg||Standard Error|Least Squares Mean
1463946|NCT00751114|Secondary|Lipid Profile: Change From Baseline to Study Endpoint||baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
1463947|NCT00751114|Secondary|Insulin Dose in the Insulin Glargine Group|Daily dose at the face-to-face visits.|visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value|The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product.|||unit per kg body weight||Standard Deviation|Mean
1463948|NCT00751114|Secondary|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint|"7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime.~Change = study endpoint - baseline."|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
1463949|NCT00751114|Secondary|Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint|"SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed).~Study endpoint was defined as the last available SMFPG mean value collected on-treatment.~Change= study endpoint - baseline"|baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate."|||mg/dL||Standard Error|Least Squares Mean
1463950|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.|||percentage of participants|||Number
1463951|NCT00751114|Secondary|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint||study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.|||percentage of participants|||Number
1463952|NCT00751114|Primary|HbA1c: Change From Baseline to Study Endpoint|Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.|baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|"The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value."|||percent||Standard Error|Least Squares Mean
1463953|NCT00751036|Secondary|Overall Survival (OS)|. OS is defined as the time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff. The median time to overall survival and its associated 95 % CI will be derived, for each treatment arm, using the time to event analysis based on Kaplan-Meier methodology.|time from the date of randomization to the date of death due to any cause or the date of last contact prior to or on the date of data cutoff, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Days||95% Confidence Interval|Median
1463954|NCT00751036|Secondary|Time to Treatment Failure|TTF, defined as the time from date of randomization to the earliest of date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than ‘Protocol deviation’ or ‘Administrative problems’.|Time from date of radomization to the earliest date of the first objective tumor, death or discontinuation, assesed until 24 months.|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Days||95% Confidence Interval|Median
1463955|NCT00751036|Secondary|Disease Control Rate (DCR)|The Disease Control Rate (Complete Response(CR), Partial Response (PD) and Stable Disease (SD) rates for each treatment arm will be computed using the exact Clopper-Pearson interval estimation methodology. DCR is defined as the percentage of patients with a best overall response of • CR, i.e. at least two determinations of CR at least 4 weeks apart without loss of response between the determinations, • PR, i.e. at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) and without loss of PR between the determinations, or • SD lasting at least 24 weeks, i.e. at least one SD or better response at least 24 weeks after randomization (and not qualifying for CR or PR).|every 2 months until 24 months (end of study)|Full analysis set (FAS): consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||Percentage of Patients||95% Confidence Interval|Number
1463967|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1463956|NCT00751036|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to modified RECIST criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.|24 months|Full Analysis Set (FAS) consisted of all randomized patients. Following the intent to treat principle, patients were analyzed according to the treatment which they were assigned at randomization.|||Days||95% Confidence Interval|Median
1463957|NCT00750919|Primary|Number of Participants Discontinuing Due to AEs|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 26 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Participants|||Number
1463958|NCT00750919|Primary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|Up to 30 weeks|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Participants|||Number
1463959|NCT00750919|Secondary|Change From Baseline in Wake Time After Sleep Onset (WASO)|"WASO was defined as the time recorded for sleep diary question 5 how much time were you awake, after falling asleep initially as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
1463960|NCT00750919|Secondary|Change From Baseline in Sleep Latency (SL)|"SL was defined as the time recorded for sleep diary question 3 how long did it take you to fall asleep’,  as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
1463961|NCT00750919|Primary|Change From Baseline in Total Sleep Time (TST)|"TST was defined as the time recorded for sleep diary question 6 how much time did you actually spend sleeping as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed."|Baseline and Week 26|The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.|||Minutes per night||Standard Deviation|Mean
1463962|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1463963|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 5 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1463964|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1463965|NCT00750893|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the post marketing study period for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1463966|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 to Year 6 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||Subjects|||Number
1463968|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 3 & Year 4 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1463969|NCT00750893|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1463970|NCT00750893|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.|During the 8 day follow-up period after each vaccine dose for Year 1 & Year 2 study period|Analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects with at least one dose of Rotarix™ vaccine administration documented.|||subjects|||Number
1463971|NCT00750880|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit|FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1463972|NCT00750880|Secondary|Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit|The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
1463973|NCT00750880|Primary|Percentage of Participants With Adverse Events (AEs): Overall Summary|Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.|Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants included in the study who received at least 1 dose of study medication and who had at least 1 postbaseline assessment of safety (post-baseline laboratory data, vital signs, or adverse events). number (n) equals (=) number of participants analyzed for the parameter within the specific population.|||percentage of participants|||Number
1463974|NCT00750880|Secondary|Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1463975|NCT00750880|Secondary|HAQ-DI Scores by Visit|HAQ-DI includes 20 questions concerning participant’s activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant’s everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1463976|NCT00750880|Secondary|Erythrocyte Sedimentation Rate by Visit|ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm/hr||Standard Deviation|Mean
1463977|NCT00750880|Secondary|C-Reactive Protein by Visit|The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mg/dL||Standard Deviation|Mean
1463978|NCT00750880|Secondary|Patient's Global Assessment of Pain by Visit|The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as “no pain” and the right-hand extreme=100 mm as “unbearable pain”. The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1463979|NCT00750880|Secondary|Physician's Global Assessment of Disease Activity by Visit|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as “maximum disease activity” (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1463980|NCT00750880|Secondary|Patient's Global Assessment of Disease Activity by Visit|The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as “maximum disease activity” (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mm||Standard Deviation|Mean
1463981|NCT00750880|Secondary|Tender Joint Count by Visit|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the last observation carried forward (LOCF) approach.|||tender joints||Standard Deviation|Mean
1463982|NCT00750880|Secondary|Swollen Joint Count by Visit|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; missing data were handled using the LOCF approach.|||swollen joints||Standard Deviation|Mean
1463983|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.|Weeks 4, 8, 12, 16, 20, and 24|ITT population; only participants with a response (ACR20/ACR50/ACR70/ACR90) were included in the analysis. n=number of participants with a response for the specified parameter|||days||95% Confidence Interval|Median
1463984|NCT00750880|Secondary|Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||participants|||Number
1463985|NCT00750880|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit|ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician’s Global Assessment of Disease Activity (VAS); participant’s assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||percentage of participants|||Number
1463986|NCT00750880|Secondary|DAS28 Scores by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
1463987|NCT00750880|Secondary|Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit|DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.|Weeks 4, 8, 12, 16, 20, and 24|ITT population|||percentage of participants|||Number
1463988|NCT00750880|Secondary|Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event|The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 <2.6.|Baseline,Weeks 4, 8, 12, 16, 20, and 24|ITT population with DAS28 ≤3.2|||days||Full Range|Median
1464000|NCT00750373|Secondary|All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies||up to 6 months after enrollment|||||||
1464001|NCT00750373|Secondary|Recurrences of Infective Endocarditis||up to 6 months after enrollment|||||||
1464002|NCT00750373|Secondary|All-cause Death||up to 6 month after enrollment|||||||
1463989|NCT00750880|Secondary|Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 <2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; Only population with complete DAS28 data were analyzed.|||participants|||Number
1463990|NCT00750880|Secondary|Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit|DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (<)2.6.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT population; no imputation of missing data was performed for this analysis.|||percentage of participants|||Number
1463991|NCT00750867|Secondary|Preliminary Efficacy of IVIg for Treatment of MSA.|The secondary outcome measure was to evaluate the preliminary efficacy of IVIG for the treatment of MSA. The primary efficacy endpoint was change of the Unified MSA Rating Scale (UMSARS-I and UMSAR-II) compared to baseline. UMSARS-I and UMSARS-II are validated semiquantitative rating scales for evaluation of severity of MSA. UMSARS-I comprises a historical review of disease-related impairments and UMSARS-II comprises motor examination. UMSARS-I has 12 questions, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-I is 0 to 48. UMSARS-II has 12 items rated by an examiner, each with assigned score 0-4, where 0 is normal and > are abnormal responses. Total range of UMSARS-II is 0 to 56. The scores of UMSARS-I and UMSARS-II at baseline (month 1) was compared with the scores obtained at the final visit (month 8) which was 8 months apart. The interventions occured at months 2-7, total six times.|Monthly, up to 8 months (including the screening visit and the final visit)||||units on a scale||Standard Deviation|Mean
1463992|NCT00750867|Primary|Number of Adverse Events up to Six Months Post-treatment|The primary outcome measure was to evaluate the safety and tolerability of the IVIG infusions in patients with multiple system atrophy. The primary endpoint was defined as the frequency of adverse events (AE). AEs including their severity and relationship to the IVIG were assessed throughout the study and at least 60 days after the last infusion. The AEs were considered to be related to the IVIG infusion (infusional AE) if they occurred during an infusion or within 72 hours afterwards. Non-infusional AEs were further classified as possible related to IVIG or likely not related to IVIG. Serious AEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization. Any AE was defined as occurrence of any symptom regardless of intensity grade.|Monthly, up to 8 months (including the screening visit and the final visit)|Two participants dropped out from the study.|||Adverse events|||Number
1463993|NCT00750815|Secondary|Phase II: Two Year Overall Survival (OS)|Overall survival by disease risk stratification after CVDD. OS: time from initiation of therapy until death from any cause.|2 years|Participants with cytogenetics and fluorescence in situ hybridisation (FISH) results available for risk stratification.|||percentage of participants||95% Confidence Interval|Number
1463994|NCT00750815|Secondary|Phase II: Progression-Free Survival (PFS)|"Progression-free survival after CVDD in participants with newly diagnosed active multiple myeloma. PFS: time from the initiation of therapy to progression, relapse or death from any causes.~Progressive Disease (PD): Progressive Disease requires any one or more of the following:~Increase of ≥ 25% from baseline in:~serum M-component and /or (the absolute increase must be ≥ 0.5 g/dL)~urine M-component and/or (the absolute increase must be ≥ 200 mg/24 h)"|Up to 50.9 months||||months||95% Confidence Interval|Median
1463995|NCT00750815|Primary|Phase II: Overall Response Rate (ORR)|Best response to CVDD chemotherapy. Overall Response: Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR). PR: ≥ 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein with urine M-protein level < 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.|Up to 6 months|All Participants with Partial Response, Very Good Partial Response, or Complete Response.|||participants|||Number
1463996|NCT00750815|Primary|Phase I - Maximum Planned Dose (MPD) Level|"Maximum Phase II planned dose of cyclophosphamide when given in combination with bortezomib, pegylated liposomal doxorubicin and Dexamethasone (CVDD) in participants with newly diagnosed active multiple myeloma. Dose levels 1, 2, 3, 4 as outlined in Treatment Arm A.~If no dose limiting toxicity (DLT) was reported in the first 3 participants at a dose level, that dose level was to be considered safe and 3 participants would be enrolled at the next dose level. If 1/3 participants in a cohort at a dose level had dose limiting toxicity (DLT), the dose level would be expanded to obtain 6 evaluable participants. MPD reflects the highest dose of drug that did not cause a DLT in 33% of participants."|9 months|All participants in Arm A. Three participants at each dose level.|||Dosing Level|||Number
1463997|NCT00750737|Secondary|Efficacy Outcome Measured as Success or Failure|Success: Defined as the absence of proven or probable invasive fungal infection through the end of prophylaxis and absence of Grade 1-4 toxicity related to prophylaxis requiring the discontinuation of the drug. Failure: Presence of proven or probable fungal infection or development of Grade 1-4 toxicity related to prophylaxis while on study drug and requiring discontinuation of study drug or inability to tolerate intravenous ABLC (due to infusion related toxicities) or oral Posaconazole (due to mucositis or vomiting).|Day 1 through Day 42|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.|||percentage of participants|||Number
1463998|NCT00750737|Primary|Incidence of Invasive Fungal Infection (IFI)|Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).|Within 7 days of antifungal prophylaxis therapy|Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.|||percentage of participants|||Number
1463999|NCT00750373|Secondary|Readmission Due to Development of Congestive Heart Failure||up to 6 months after enrollment|||||||
1464004|NCT00750360|Secondary|Number of Participants Reporting Serious Adverse Events (SAE).|"An SAE is any untoward medical occurrence that:~results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above."|Within 1 month following vaccination||||participants|||Number
1464005|NCT00750360|Secondary|Number of Participant Reporting Unsolicited Adverse Events.|An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day follow-up period (Day 0 to Day 20) after vaccination||||participants|||Number
1464006|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fatigue, fever, shivering, malaise, myalgia, headache, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.||||participants|||Number
1464007|NCT00750360|Secondary|Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.|Solicited local adverse events assessed include induration, pain, redness, and swelling. Solicited general adverse events assessed include fever, shivering, and sweating/diaphoresis.|During the 4-day follow up (Day 0 to 3) after vaccination.||||participants|||Number
1464008|NCT00750360|Primary|Number of Participants Reporting Severe Unsolicited Adverse Events|"An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Severe unsolicited adverse events are defined as adverse events which prevent normal, everyday activities"|During the 21-day follow-up period (Day 0 to Day 20) after vaccination||||participants|||Number
1464009|NCT00750308|Primary|Insulin Sensitivity|As assessed using IV glucose tolerance test and calculated using Min Mod units mU/mm|three weeks|Those who completed protocol|||(mU/L)-1x(min)-1xL||Standard Error|Mean
1464010|NCT00750308|Primary|Beta Cell Function|Beta cell function as measured during a frequently sampled IV glucose tolerance test|3 hours||||microU/mM||Standard Error|Mean
1464011|NCT00750282|Secondary|Standard Uptake Value Ratios for Florbetaben Signal|The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.)|90-110 min post injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||ratio||Standard Deviation|Mean
1464012|NCT00750282|Secondary|Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)|The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement.|45-60 min, 90-110 min, 110-130 min|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||Kappa coefficient|||Number
1464013|NCT00750282|Secondary|Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment|PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed|45 - 60 min and 110 - 130 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||percentage of subjects||95% Confidence Interval|Number
1464014|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.|"Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores “2 or 3”) which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score “1) which was considered a match for specificity.~The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia.~Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media."|90 - 110 min after IMP injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis|||percentage of subjects||95% Confidence Interval|Number
1464015|NCT00750282|Primary|Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth|"Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis.~Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used.~Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of “1” (without beta-amyloid plaque load) or “2” (with minor beta-amyloid plaque load) was considered normal and a BAPL score of “3” (with significant beta-amyloid plaque load) was considered abnormal.~Using algorithm B (Average), a brain scan of a subject with a BAPL score of “1” was considered normal and a brain scan with a BAPL score of “2” or “3” was considered abnormal. Algorithm B was used in Part B and in the final"|90 - 110 min after investigational medical product (IMP) injection|All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis.(n=146)|||percentage of subjects||95% Confidence Interval|Number
1464029|NCT00750191|Primary|Physical Function|"Physical function as measured by the Short Form (36) Health Survey questionnaire physical function component.~Scale range for physical function component: 0 (minimum: worse outcome) to 100 (maximum: best outcome)."|6 months||||units on a scale||Standard Deviation|Mean
1464016|NCT00750269|Secondary|Rate of Late Toxicity (i.e., Occurs > 1 Year After the Start of SBRT) of ≥ Grade 3 as Assessed by NCI CTCAE v4.0|Percentage of patients who developed any treatment-related toxicity after the first year following the start of SBRT.|From start of treatment to end of follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment who were observed more than 1 year after start of SBRT|||percentage of participants||95% Confidence Interval|Number
1464017|NCT00750269|Secondary|Rate of Toxicity ≥ Grade 3 (Other Than DLT) Within One Year as Assessed by NCI CTCAE v4.0|Rate of patients developing any treatment-related toxicity during the first year following the start of SBRT that is not among the types considered as a dose-limiting toxicity.|From start of SBRT until 1 year.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1464018|NCT00750269|Secondary|Distant Metastases|Distant metastases is defined as the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer. Distant metastases progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, distant failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1464019|NCT00750269|Secondary|Nodal Progression|Regional nodal progression is defined as appearance after protocol therapy of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum. Regional nodal progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of patients||95% Confidence Interval|Number
1464020|NCT00750269|Secondary|Local Progression|Local progression is the same as primary tumor failure (PTF) which refers to the primary treated tumor after protocol therapy and corresponds to meeting both of the following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. For outcome analysis, Marginal Failures (MF) and Involved Lobe Failures will also be counted as PTF. Local progression was assessed using the cumulative incidence method to estimate the 2-year failure rate. Arms were not compared/tested.|From randomization to date of death, regional failure or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1464021|NCT00750269|Secondary|Overall Survival|An event for overall survival is death due to any cause. Overall survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1464022|NCT00750269|Secondary|Progression-free Survival|Progression-free survival is defined as the state of being alive without progression of disease. A failure is the first of the following: local progression, regional progression, distant metastasis, or death. Progression-free survival was assessed at the maximum tolerated dose using the Kaplan-Meier method to estimate the 2-year survival rate. Arms were not compared/tested.|From randomization to date of death, failure (local, regional or distant) or last follow-up. Analysis occurs after all patients have been potentially followed for 24 months, approximately 7.5 years from the start of the study.|All eligible patients who started study treatment|||percentage of participants||95% Confidence Interval|Number
1464023|NCT00750269|Primary|(Phase II) Primary Tumor Control Rate at the Maximum Tolerated Dose (MTD)|Primary tumor control is defined as the absence of primary tumor failure. Primary tumor failure (PTF) refers to the primary treated tumor after protocol therapy and corresponds to meeting following two criteria: 1) Increase in tumor dimension of 20% as defined above for local enlargement (LE); 2) The measurable tumor with criteria meeting LE should be avid on Positron Emission Tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, OR the measurable tumor should be biopsied confirming viable carcinoma. Marginal Failures (MF) and Involved Lobe Failures were also counted as PTF. The cumulative incidence method was used to estimate primary tumor control rate. The 90% confidence interval for local control was calculated using bootstrapping methods. Per the protocol, only the MTD dose level was to be analyzed. However, due to the quantity of patients enrolled on Dose Level 8 as well as safety concerns, Dose Level 8 was analyzed also.|From start of SBRT to 2 years.|All eligible patients who started study treatment|||percentage of participants||90% Confidence Interval|Number
1464024|NCT00750269|Primary|(Phase I) Maximum Tolerated Dose of Stereotactic Body Radiotherapy (SBRT) as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0|Maximum tolerated dose (MTD) defined as dose most closely associated with a 20% probability of experiencing a toxicity <= 1 year from start of SBRT from following dose-limiting toxicities: Gr 3-5 Cardiac: Pericardial effusion, Pericarditis, Restrictive cardiomyopathy; Gr 4-5 GI: Dysphagia, Esophagitis, Esophageal fistula/obstruction/perforation/stenosis/ulcer/hemorrhage; Gr 3-5 Nervous System Disorders: Brachial plexopathy, Recurrent laryngeal nerve palsy, Myelitis; Gr 3-5 Respiratory: Atelectasis (gr 4-5 only), Bronchopulmonary/mediastinal/pleural/tracheal hemorrhage, Bronchial/pulmonary/bronchopleural/tracheal fistula, Hypoxia (provided gr 3 is worse than baseline), Bronchial/tracheal obstruction, Pleural effusion, Pneumonitis, Pulmonary fibrosis; Changes in Pulmonary Function Tests per SBRT Pulmonary Toxicity Scale, Gr 3-5: FEV1 decline, FVC decline; Any Gr 5 adverse event attributed to treatment. Dose level was determined by time-to-event continual reassessment method (TITE-CRM).|From start of SBRT to 1 year|All eligible patients who started study treatment|||Gy/FX|||Number
1464025|NCT00750204|Primary|Amount of Sedatives Used||48 hours|Data was not collected for this outcome measure, as the study was terminated prematurely.||||||
1464030|NCT00750152|Secondary|Mycological Cure and Treatment Effectiveness|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.|Week 4 (two weeks post-treatment)|This is the Full Analysis Set (FAS)comprising of subjects in the SES with a positive culture at Baseline for whom the primary efficacy variable was available. This was a modified intent to treat principle because the culture results were not available before the start of treatment.|||percentage of subjects|||Number
1464031|NCT00750152|Primary|Percentage of Subjects|Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.|Week 4 post-baseline|The Full Analysis Set (FAS)is the subset of all subjects in the Safety Evaluation Set (SES)with a positive culture at baseline and for whom the primary efficacy variable is available. This is a modified intent-to-treat (MITT) principle because the culture results were not available before the start of treatment.|||percentage of subjects with complete cur|||Number
1464032|NCT00750139|Secondary|Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6|Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.|Week 6|This was the Full Analysis Set (FAS) comprising of subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable was available. This was a Modified Intent to Treat (MITT) principle because the culture results were not available at the start of treatment.|||percentage of Subjects|||Number
1464033|NCT00750139|Primary|Percentage of Subjects With Complete Cure at Week 6.|"The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6.~The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6.~Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale."|Week 6|This is based on the Full Analysis Set (FAS). The FAS is the subset of all subjects in the Safety Evaluation Set (SES) with a positive culture at baseline for whom the primary efficacy variable is available. This is a modified intent to treat (MITT) principle because the culture results will not be available before the start of treatment.|||percentage of subjects with complete cur|||Number
1464034|NCT00750061|Secondary|Changes in Functional Independence Measure (FIM) Motor Subscale and Visual Analog Scale (VAS) for Pain|Changes from Baseline to Week 6 and Month 6 in Functional Independence Measure (FIM) motor subscale (0 ~ 91, the higher the better), Visual Analog Scale (VAS) for pain (0 ~ 100, the less the better)|6 months|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1464035|NCT00750061|Primary|Changes of Neurological Scores for Baseline|Changes of Motor Scores (0 ~ 100), Pin Prick Scores (0 ~ 112) and Light Touch Scores (0 ~ 112) from Baseline to Week 6 and Month 6. The higher the changes the better the functional improvement.|6 months|Full Analysis Set|||units on a scale||Standard Deviation|Mean
1464036|NCT00749996|Secondary|To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).|"The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI).~The ODI is a low back pain disability questionnaire used to measure a patient’s permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability."|12 Months||||patient's score||Standard Deviation|Mean
1464037|NCT00749996|Primary|To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).|The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning ‘no pain’ and 10cm meaning ‘worst possible pain’) will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.|6 Months||||units on a scale||Standard Deviation|Mean
1464038|NCT00749957|Secondary|Participants With Changes in Best Corrected Visual Acuity|Increase in BCVA of 7 or more letters at Year 2 visit compared to average baseline value|2 years||||participants|||Number
1464039|NCT00749957|Secondary|Participants With Changes in Visual Fields|Improvement in the central 30 degree visual field, measured by static perimetry, at one or more time points after treatment, that was greater than the limit of agreement for baseline values .|2 years||||participants|||Number
1464040|NCT00749957|Primary|Number of Participants Experiencing Ocular or Non-ocular Adverse Events||2 years||||participants|||Number
1464041|NCT00749944|Secondary|Change From Baseline in the Number of Cigarettes Smoked Per Day||Baseline (Week 0) to Week 2|FAS; (n)=number of subjects with at least 1 dose of study drug and an observation for a given day.|||cigarettes smoked per day||Standard Deviation|Mean
1464042|NCT00749944|Secondary|Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation)|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (during treatment) in the previous 7 days and who did not have carbon monoxide of more than 10 parts per million for that observation (if measured).|Week 5 to Week 13|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464043|NCT00749944|Secondary|Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation|Participants who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory, which was used to collect the information of cigarette or other nicotine use during the study) and who did not have carbon monoxide of more than 10 parts per million at any time from Week 9 to Week 12|Week 9 to Week 12|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464089|NCT00749606|Primary|Weight|Weight (kg)|baseline, 1, 2, 3 years||||kg||Standard Deviation|Mean
1464044|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score|SDAS total scores ranged from 0 (not present) to 44 (extremely severe). Participants exceeding the threshold had a SDAS total score of more than 6 out of 44.|Baseline B (Week 2) to Week 4 (Period BC)|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464045|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Total score ranged from 30 (less impulsive) to 120 (more impulsive). Participants exceeding the threshold had a BIS-11 total score more than or equal to 70 out of 120. BIS-11 total scores of more than or equal to 70 could reflect clinically important and potentially pathological impulsivity.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464046|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Suicidality total score ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency). No threshold criterion was determined for OAS-m Suicidality total score.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|The number of participants above the threshold for the OAS-m Suicidality total score was not analyzed as the majority of observations were recorded as 0.|||participants|||Number
1464047|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Irritability total score ranged from 0 (no irritability) to 10 (extreme irritability). Participants exceeding the threshold had an OAS-m Irritability total score of more than or equal to 2 out of 10. OAS-m Irritability total scores of more than or equal to 2 reflect clinically important irritability.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464048|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score|The OAS-m contains 3 scales: Aggression, Irritability, and Suicidality. Aggression total score ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week. Participants exceeding the threshold had an OAS-m Aggression total score of more than or equal to 3 out of any number with no upper limit depending on the frequency of agressive behaviour in a week. OAS-m Aggression total scores of more than or equal to 3 reflect clinically important aggression.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464049|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms. Total scores ranged from 0 (not affected) to 56 (very severely affected). Participants exceeding the threshold had a HAM-A total score of more than or equal to 14 out of 56. HAM-A total scores of more than or equal to 14 may reflect clinically noteworthy levels of anxiety.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464050|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms. Total score ranged from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Participants exceeding the threshold had a MADRS total score of more than 14 out of 60. MADRS total scores exceeding 14 may represent clinically notable effective symptomatology.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively. Statistical analyses were not performed for Period AB due to the small number of participants exceeding the threshold.|||participants|||Number
1464051|NCT00749944|Secondary|Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score|POMS total mood disturbance (TMD) summary results were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance). Participants exceeding the threshold had an increase from baseline of 1 standard deviation of the TMD baseline T-score plus 1 or more.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||participants|||Number
1464052|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale|The MNWS increased appetite subscale contains 1 item (increased appetite) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no increased appetite) to 4 (extreme increased appetite).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464090|NCT00749580|Secondary|Virologic Suppression of < 75 Copies/ml at 48 Weeks||at 48 weeks for each patient||||participants|||Number
1465563|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 30||Baseline and week 30|Treated Set with values for HbA1c at baseline and week 30. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1464053|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale|The MNWS restlessness subscale contains 1 item (restlessness) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no restlessness) to 4 (extreme restlessness).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464054|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale|The MNWS urge to smoke subscale contains 1 item (urge to smoke) rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores ranged from 0 (no urge to smoke) to 4 (extreme urge to smoke).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464055|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale|The MNWS insomnia domain subscale contains 2 items (difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average of the 2 items and ranged from 0 (no insomnia) to 4 (extreme insomnia).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464056|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale|The MNWS negative affect domain subscale contains 4 items (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Scores were the average from all 4 items and ranged from 0 (no negative affect) to 4 (extreme negative affect).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464057|NCT00749944|Secondary|Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score|The MNWS total score contains 9 items (urge to smoke; depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; difficulty staying asleep). Each item was rated from 0 to 4 where 0=not at all, 1=slight, 2=moderate, 3=quite a bit, and 4=extreme. Total scores were the average score for all 9 items and ranged from 0 (no withdrawal symptoms) to 4 (extreme withdrawal symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464058|NCT00749944|Primary|Change From Baseline in the Barratt Impulsiveness Scale – Version 11 (BIS-11): Total Score|The BIS-11 is a 30-item self-report questionnaire designed to assess general impulsiveness taking into account the multifactorial nature of the construct. Possible responses to each item were: 1=rarely/never, 2=occasionally, 3=often, and 4=almost always/always. Scores of Items 1, 7, 8, 9, 10, 12, 13, 15, 20, 29 and 30 were reversed when calculating the total score. Total score ranged from 30 (less impulsive) to 120 (more impulsive).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464059|NCT00749944|Primary|Change From Baseline in the Social Dysfunction and Aggression Scale (SDAS): Total Score|The SDAS contains 11 items with 5 possible responses: 0=not present, 1=doubtful or very mild, 2=mild to moderate, 3=severe, and 4=extremely severe. The SDAS was collected 3 times a day during the inpatient abstinence period (BC). Total scores ranged from 0 (not present) to 44 (extremely severe).|Baseline B (Week 2) to Week 4 (Period BC)|No change from baseline analysis was performed on the SDAS total score as the majority of observations were recorded as 0.|||scores on a scale||Standard Error|Least Squares Mean
1464060|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Suicidality total score was calculated by summing the items Q7 to 7b. Scores for Q7 ranged from 0 (none) to 6 (very extreme) and scores for Q7a to 7b ranged from 0 (none) to 5 (extreme). Total scores ranged from 0 (no suicidal tendency) to 16 (extreme/very extreme suicidal tendency).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|No change from baseline analysis was performed on the OAS-m Suicidality total score as the majority of observations were recorded as 0.|||scores on a scale||Standard Error|Least Squares Mean
1464061|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Irritability total score was calculated by summing the items in Q5 to 6. Scores for each question ranged from 0 (not at all) to 5 (extreme). Total scores ranged from 0 (no irritability) to 10 (extreme irritability).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464127|NCT00749190|Secondary|Change of HbA1c From Baseline Over Time|Change of HbA1c from baseline over time. Results presented stem from a repeated measures analysis.|Baseline and weeks 4, 8 and 12|FAS. Imputation method used was the classical LOCF (CLOCF) approach which uses always the last available value.|||percentage of HbA1c||Standard Error|Mean
1464062|NCT00749944|Primary|Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score|The OAS-m contains 3 scales: Aggression (Questions [Q]1 to 4), Irritability (Q5 to 6), and Suicidality (Q7 to 7b). Aggression total score was calculated by summing the weighted scores in Q1 to 4. Scores for each question ranged from 0 (no events) to 5 (very severe events). Total scores ranged from 0 (no aggression) to any number with no upper limit depending on the frequency of agressive behaviour in a week.|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464063|NCT00749944|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score|HAM-A measures treatment-related changes in generalized anxiety symptoms and is a 14-item questionnaire. Each item was scored from 0 (not present) to 4 (very severe) and a lower score indicated less affected. Total scores ranged from 0 (not affected) to 56 (very severely affected).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464064|NCT00749944|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score|The MADRS measures the overall severity of depressive symptoms and is a 10-item checklist. Each item was rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464065|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale|POMS Confusion subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Efficient. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464066|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale|POMS Fatigue subscale data were responses to 7 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464067|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale|POMS Vigor subscale data were responses to 8 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464068|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale|POMS Anger-Hostility subscale data were responses to 12 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464069|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale|POMS Depression-Dejection subscale data responses to 15 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464070|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale|POMS Tension-Anxiety subscale data were responses to 9 items regarding ‘How you feel right now?’ on a scale of 0=not at all, 1=a little, 2=moderately, 3=quite a bit, and 4=extremely. All items were rated in the same direction except for Relaxed. Summary results (subscale scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|FAS; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464209|NCT00748241|Secondary|Implant Failure|Total number of implants reported as failure.|3 years after implant placement|Number of failed implants based on total number of patients enrolled and total number of placed implants|||Number of implants|Participants||Number
1464071|NCT00749944|Primary|Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD)|POMS TMD were responses to 65 items in 6 subscales (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor, Fatigue, and Confusion), on ‘How you feel right now?’ (scale:0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely). All items were rated in the same direction except for Relaxed and Efficient in the Tension-Anxiety and Confusion subscales. TMD was the sum of the scores of all 6 subscales but weighting Vigor negatively. Summary results (TMD scores) were presented as transformed T-scores ranging from 30 (less disturbance) to 80 (more disturbance).|Baseline A (Week 0) to Week 2 (Period AB), Week 4 (Period AC), Week 12 or relapse (Period AD), and Week 12 (Period AE). Baseline B (Week 2) to Week 4 (Period BC), Week 12 or relapse (Period BD), and Week 12 (Period BE).|Full analysis set (FAS): All randomized subjects with at least 1 dose of study drug and at least 1 post-baseline neuropsychiatric evaluation or Minnesota Nicotine Withdrawal Scale (MNWS) obtained; (n)=number of subjects with data for analysis for varenicline and placebo, respectively.|||scores on a scale||Standard Error|Least Squares Mean
1464072|NCT00749931|Post-Hoc|Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens||Up to 2 months post-surgery||||percentage of participants|||Number
1464073|NCT00749931|Primary|The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.|Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively|two weeks after surgery|"The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen (PSS – Positive specimen subjects)"|||percentage of participants analyzed|||Number
1464074|NCT00749775|Secondary|Number of Participants That Responded to Selara Treatment.|Number of participants among the efficacy analysis population that responded to Selara treatment.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||participants|||Number
1464075|NCT00749775|Secondary|Change in Diastolic Blood Pressure Over Time.|The primary analysis item was the mean diastolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||mmHg||Standard Deviation|Mean
1464076|NCT00749775|Secondary|Change in Systolic Blood Pressure Over Time.|The primary analysis item was the mean systolic blood pressure at 4, 8, and 12 weeks of the observation period or at last evaluation date if Selara was terminated prematurely.|12 weeks|The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately).|||mmHg||Standard Deviation|Mean
1464077|NCT00749775|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Serious treatment related adverse events mean those that may lead to death, life-threatening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anomaly/congenital deficiency, or other medically significant events or disorder.|12 weeks|No statistical analysis provided for the frequency of serious treatment related adverse events.|||participants|||Number
1464078|NCT00749775|Primary|Number of Participants With Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Selara, irrespective of causal relationship to Selara (including clinically problematic abnormal changes in laboratory test values). Treatment Related Adverse Events were evaluated in company with the causal relationship to Selara.|12 weeks|No statistical analysis provided for the frequency of Treatment Related adverse events.|||participants|||Number
1464079|NCT00749684|Primary|Relapse Free Survival Time|Median time to recurrence according to Kaplan Maier evaluation|Throughout 12 months of treatment and 24 months of follow-up||||months||Full Range|Median
1464080|NCT00749684|Primary|Number of Participants With Disease Recurrence|Number of participants with disease recurrence was being measured.|Throughout 12 months of treatment and 24 months of follow-up|138 participants with malignant melanoma, 88 male participants and 50 female participants were evaluated.|||participants|||Number
1464081|NCT00749671|Secondary|Patient Recall of Defibrillation Testing|The patient recall of the testing will be assessed at 30 minutes, as answered with a yes/no.|30 minutes||||percentage of patients with DFT recall|||Number
1464082|NCT00749671|Primary|Observer's Assessment of Alertness/Sedation (OAAS) Rating Scale at 30 Minutes|"Sedation level was evaluated and graded according to the observer's assessment of alertness/sedation (OAAS) rating scale. This scale has 6 possible measures of consciousness:~OAAS score 5—awake and responds readily to name spoken in normal tone.~OAAS score 4—lethargic responses to name in normal tone.~OAAS score 3—responds only after name is called loudly and/or repeatedly.~OAAS score 2—responds only after name called loudly and mild shaking.~OAAS score 1—does not respond when name is called loudly and mild shaking or prodding.~OAAS score 0—does not respond to noxious stimulation."|30 minutes||||units on a scale||95% Confidence Interval|Mean
1464083|NCT00749606|Secondary|International Physical Activity Questionnaire|Measure of physical activity is calculated as in mets/week|baseline, 6 months, 1 and 2 years||||mets per week||Standard Error|Mean
1464084|NCT00749606|Secondary|SF-12 Physical Summary Score|The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).|baseline, 6 months, 1 and 2 years||||units on a scale||Standard Error|Mean
1464085|NCT00749606|Secondary|Health Behaviors (Diet, Physical Activity)|National Cancer Institute Fat screener|baseline, 6 months, 1 and 2 years||||percentage of daily calories from fat||Standard Error|Mean
1464086|NCT00749606|Secondary|Fasting Glucose Level|Fasting glucose (mg/dL)|baseline, 1, 2, 3 years||||mg/dL||Standard Deviation|Mean
1464087|NCT00749606|Secondary|Fasting Lipid Panel|LDL-cholesterol (mg/dL)|baseline, 1, 2, 3 years|Note: LDL-cholesterol measurements were not available for 13 participants in the Individual Call arm and 6 participants in the Conference Call arm|||mg/dL||Standard Deviation|Mean
1464088|NCT00749606|Secondary|Blood Pressure|Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)|baseline, 1, 2, 3 years||||mmHg||Standard Deviation|Mean
1464091|NCT00749580|Primary|Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen|Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen.|at 24weeks for each patient||||participants|||Number
1464092|NCT00749476|Primary|Number of Participants Reporting Efficacy|Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.|4 months|Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.|||Participants|||Number
1464093|NCT00749463|Secondary|Point Prevalence Smoking Abstinence (PPSA)|Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.|24 Weeks||||Participants|||Number
1464094|NCT00749463|Primary|Smoking Abstinence|Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day|24 Weeks||||Participants|||Number
1464095|NCT00749463|Secondary|Smoking Consumption Per Week|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)|24 Weeks from last visit:||||Cigarettes||Standard Deviation|Mean
1464096|NCT00749463|Secondary|Smoking Consumption Per Day|Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)|24 Weeks from last visit:||||Cigarettes||Standard Deviation|Mean
1464097|NCT00749463|Secondary|Carbon Monoxide (CO)-Verified Smoking Reduction|Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)|Baseline to Week 24||||Percentage of Participants||Standard Deviation|Mean
1464098|NCT00749463|Primary|Self-Reported Smoking Reduction|Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day|24 Weeks||||Percentage of Participants||Standard Deviation|Mean
1464099|NCT00749463|Primary|Treatment-Related Adverse Events|Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher|24 Weeks|Safety Analysis Set (ITT)|||Percentage of Participants|||Number
1464100|NCT00749398|Secondary|Number of Participants With Satisfactory Health Status|"Participant's opinion on his/her health status, as assessed by the following question: Think about all the ways your psoriasis is affecting you, do you consider that your current status is satisfactory? (Yes/No)"|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Participants|||Number
1464101|NCT00749398|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI ranged from 0 (no effect on participant's life) to 30 (extremely large effect on participant's life) and was computed by summing the score (each ranging from 0 to 3) of each of a 10-item questionnaire.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464102|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Participant|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464103|NCT00749398|Secondary|Static PGA Score as Assessed by the Participant|Participants assessed their psoriasis at Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), and Week 30 (Visit 6) according to the Static PGA score, which ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464104|NCT00749398|Secondary|Nail Psoriasis Severity Index (NAPSI) Score|The nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail was evaluated, and the sum of all the nails was the total NAPSI score. The sum of the scores from all nails ranged from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464105|NCT00749398|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI ranged from 0 (no symptoms) to 72 (very marked symptoms) and assessed 3 clinical signs within each area (head, arms, trunk, and legs): erythema (redness), induration (thickness), and desquamation (scaling).|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464106|NCT00749398|Secondary|Percent Body Surface Area (BSA) Involved With Psoriasis||Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)|Per protocol analysis.|||Percent BSA Involved with Psoriasis||Standard Deviation|Mean
1464107|NCT00749398|Secondary|Dynamic PGA Score as Assessed by the Investigator|The dynamic PGA was scored twice, at the middle and at the end of the observation period. Clinical improvement from Baseline (Visit 1) was evaluated with a 10 cm-VAS ranging from 0 (no improvement) to 10 (disappearance of lesions) at the Week 14 (Visit 4) and Week 30 (Visit 6) visits.|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464108|NCT00749398|Primary|Dynamic Photographic PGA Score as Assessed by Two Dermatologists|The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).|Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464109|NCT00749398|Secondary|Static PGA Score as Assessed by the Investigator|Static PGA was assessed at each visit by the investigator. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464110|NCT00749398|Primary|Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists|Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.|Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)|Per protocol analysis.|||Score on a scale||Standard Deviation|Mean
1464111|NCT00749268|Secondary|Hernia Recurrence||Discharge, 1 Month, 6 Month, 1 year||||participants|||Number
1464112|NCT00749268|Secondary|Quality of Life|"Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.~The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Pre-op, Month 1, Month 6, 1 year|Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.|||units on a scale||Standard Deviation|Mean
1464113|NCT00749268|Primary|Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events||One year||||participants|||Number
1464114|NCT00749268|Primary|Postoperative Pain|"Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.~Scale is 0 - 10 with 0 being no pain and 10 being worst pain imaginable."|Discharge, Month 1, Month 6, Month 12|1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.|||units on a scale||Standard Deviation|Mean
1464115|NCT00749203|Secondary|Hopkins Verbal Learning Test (HVLT)|Repeatable test of memory acquisition and delayed recall of words. It is a three-trial list learning and free recall task comprising 12 words, 4 words from each of three semantic categories. Total Recall score range is 0 to 36.|20 to 40 minutes after infusion|data not collected||||||
1464116|NCT00749203|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|Clinician-administered questionnaire measuring depressive symptoms. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Mean difference between baseline and 2 weeks.|24 hours after first infusion||||units on a scale||Standard Deviation|Mean
1464117|NCT00749203|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|Self-report questionnaire measuring depressive symptoms. Each item is rated 0 (no depression) to 3 (severe depression). The total score ranges from 0-27.|24 hours after first infusion||||units on a scale||Standard Deviation|Mean
1464118|NCT00749203|Secondary|Clinician-Administered PTSD Scale (CAPS)|Clinician-administered structured interview measuring PTSD symptoms. frequency score - scale 0 = none of the time to 4 = most or all of the time intensity score - scale 0 = none to 4 = extreme To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. 30 questions scale, with total score ranging from 0 to 240.|7 days after first infusion|Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.|||units on a scale||Standard Deviation|Mean
1464119|NCT00749203|Primary|Impact of Event Scale - Revised (IES-R)|"A 22-item self-report questionnaire measuring PTSD symptoms. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely)"|7 days after first infusion|Not all participants returned for the 1 week follow up visit. There were 19 participants from the Ketamine group and 15 participants from the Midazolam group who returned for their followup visit and completed the IES-R at the 1 week follow up visit.|||units on a scale||Standard Deviation|Mean
1464120|NCT00749190|Secondary|Trough Concentrations of Empagliflozin in Plasma|(Pre-dose) trough concentrations of Empagliflozin in plasma, within 30 minutes of dosing.|Days 28, 56 and 84|All patients who received at least one dose of Empagliflozin and have some Pharmacokinetic (PK) data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
1464121|NCT00749190|Secondary|Change of Body Weight After 12 Weeks of Treatment|Results for change of body weight after 12 weeks of treatment based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||kg||Standard Error|Mean
1464122|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B)|HOMA-%B (to assess insulin beta cell function) is defined as (20 x FPI)/(FPG-3.5), FPG in mg/dl. Results are based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU / mmol||Standard Error|Mean
1464123|NCT00749190|Secondary|Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR)|HOMA-IR (to assess insulin resistance) is defined as (FPI x FPG)/22.5. Results based on ANCOVA.|Baseline and 12 weeks|FAS (CLOCF)|||mU/L x mmol/L||Standard Error|Mean
1464124|NCT00749190|Secondary|Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI)|Results for change of FPI from baseline at week 12 based on ANCOVA|Baseline and 12 weeks|FAS (CLOCF)|||mU/L||Standard Error|Mean
1464125|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c lowered at least 0.5%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1464126|NCT00749190|Secondary|Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment|Results for HbA1c categories at week 12 (Proportion of patients with HbA1c less than equal to 7%) based on logistic regression|Baseline and 12 weeks|FAS (CLOCF)|||percentage of participants|||Number
1468159|NCT00720330|Primary|Postoperative Opioid Consumption in Oral Oxycodone Equivalents|The cumulative opioid consumption after surgery until the end of second postoperative day.|2 days after surgery||||mg||Full Range|Mean
1464128|NCT00749190|Secondary|Change of FPG From Baseline After 12 Weeks of Treatment|"Change of Fasting Plasma Glucose (FPG) from baseline after 12 weeks of treatment. Results presented stem from a repeated measures analysis.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|FAS using modified LOCF imputation method|||mg/dL||Standard Error|Mean
1464129|NCT00749190|Primary|Change From Baseline in HbA1c After 12 Weeks of Treatment|"Change from baseline in HbA1c after 12 weeks of treatment.~In the measured values adjusted means are displayed. For means for the placebo and empagliflozin arms are from the model excluding the sitagliptin open label (OL) arm. The mean for the sitagliptin OL arm is from the model with just this treatment group and the placebo group."|Baseline and 12 weeks|Full analysis set (FAS) consisting of all randomized patients who were treated with at least one dose of study drug and has a baseline measurement of the primary endpoint. The imputation method used was a modified last observation carried forward (LOCF) approach which used linear interpolation, LOCF and worst observation carried forward (WOCF).|||percentage of HbA1c||Standard Error|Mean
1464130|NCT00749125|Primary|Activations in Different Cortical Regions Caused by Emotionally Evocative Task|MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task. These differences were expected to lessen significantly following treatment in the depressed group.|baseline and week 8|23 patients with major depression were matched with 18 demographically similar healthy controls. Depressed subjects were treated with Lexapro 10 mg/day, initiated immediately following the first fMRI scan.|||Voxels||Standard Deviation|Mean
1464131|NCT00749073|Primary|Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.|The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.|Baseline and Six months|All available treated patients with six month follow-up.|||units on a scale||95% Confidence Interval|Mean
1464132|NCT00749073|Primary|Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire|Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.|Baseline and Month 6|All treated patients having six month follow-up were included.|||units on a scale||Standard Deviation|Mean
1464133|NCT00749073|Primary|Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).|Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.|Baseline and Six Months|All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported.|||units on a scale||Standard Deviation|Mean
1464134|NCT00748982|Secondary|QTcF Interval|Maximum QTcF observed for each patient. QTcF is the QT interval corrected for the RR interval using the Fridericia formula|Up to 24 hours following start of IV dosing.||||ms||95% Confidence Interval|Mean
1464135|NCT00748982|Secondary|Area Under Curve (AUC) ( µmol*h/L) of AZD1305|To evaluate the pharmacokinetics of AZD1305, given as an iv infusion, in patients with left ventricular dysfunction|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.||||µmol*h/L||Full Range|Mean
1464136|NCT00748982|Secondary|Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group|To evaluate the tolerability and safety of AZD1305 given as an iv infusion to patients with left ventricular dysfunction.|From randomisation to last study visit (mean infusion time 1.6 hours)||||Participants|||Number
1464137|NCT00748982|Primary|Left Ventricular Ejection Fraction (LVEF), Change From Baseline|To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.|From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out||||Percent change||95% Confidence Interval|Mean
1464138|NCT00748969|Secondary|Change in Neuropsychological Functioning and Brain Volumetrics.||12 months|||||||
1464139|NCT00748969|Secondary|Change in Muscle Strength Measured by Biodex and Hand Grip Dynamometer.||12 months|||||||
1464140|NCT00748969|Secondary|Change in Mobility Measured by Force and Gait Measurements.||12 months|||||||
1464141|NCT00748969|Secondary|Change in Bone Mineral Density, Content, and Strength by DXA and pQCT, and Change in Serum Markers of Bone Metabolism.||12 months|||||||
1465564|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 18||Baseline and week 18|Treated Set with values for HbA1c at baseline and week 18. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1464142|NCT00748969|Secondary|Safety of Nutropin AQ® in Children With MPS I, II, and VI. Safety Endpoints Are: • Physical Examinations • Fundoscopic Examinations • Adverse Events • Radiographic Examinations of Spine and Lower Extremities|"Three days after starting treatment with Nutropin AQ the subjects mother reported that the study subject developed headache, increased noisy and more labored breathing (history of obstructive sleep apnea treated with BIPAP), and fatigue with watery eyes. Symptoms resolved with discontinuation of Nutropin AQ and before evaluation by physician. Subject withdrew from the study due to these adverse effects."|1 months|||||||
1464143|NCT00748969|Primary|Change in Growth Velocity From Baseline to End of Study Year 1.||12 months|"Zero participants analyzed in the No growth hormone treatment group due to subject withdrew from study as soon as informed they were assigned the no treatment group."|||cm/yr|||Number
1464144|NCT00748956|Secondary|Profile of Mood States (POMS)|measure in 2 hours post intranasal administration and on the next morning|on study day 2|data not collected||||||
1464145|NCT00748956|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|measure in 2 hours post intranasal administration|on study day 2|data not collected||||||
1464146|NCT00748956|Secondary|Post-sleep Questionnaire|measure in the morning|on study day 2|data not collected||||||
1464147|NCT00748956|Secondary|Appetite Scale|measure in 2 hours post intranasal administration|on study day 2|data not collected||||||
1464148|NCT00748956|Secondary|Systematic Assessment of Treatment-Emergent Effects (SAFTEE)|Number of participants with serious adverse events|on study day 2||||Participants|||Count of Participants
1464149|NCT00748956|Primary|Levels of NPY in CSF|Levels of Neuropeptide Y in the cerebrospinal fluid|on study day 2||||pg/mL||Standard Deviation|Mean
1464150|NCT00748865|Primary|Drop Comfort|Drop comfort grading scale is a 0 to 9 scale, with 0 meaning most comfortable and 9 meaning most uncomfortable,|once upon instillation||||Units on a scale||Standard Deviation|Median
1464151|NCT00748826|Primary|Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised of a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participant|||Number
1464152|NCT00748826|Primary|Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the In-vitro TB test (cellular blood test, i.e. gamma interferon release assays) per clinical testing as the first screening test was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
1464153|NCT00748826|Primary|Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (Multiple puncture Tuberculin skin test) per clinical testing as the first screening test was presented in three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
1464154|NCT00748826|Primary|Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment|"In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (Tuberculin sensitivity skin test by intradermal injection) per clinical testing as the first screening test was presented in~three categories:~Yes~Missing"|Baseline|Of 576 participants enrolled on study (508 with rheumatoid arthritis and 68 with psoriatic arthritis), only data from the 508 rheumatoid arthritis participants was evaluated.|||participants|||Number
1464155|NCT00748709|Secondary|Number of Patients With Diarrhea or Rash|Number of Patients with Diarrhea or Rash|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
1464156|NCT00748709|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) for Patients on 50mg on Day 15|Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15 for patients on 50mg on day 15.|Day 15||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1464157|NCT00748709|Primary|Percentage of Participants With Objective Response (OR)|OR is defined as the percentage of patients with complete response (CR) or partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks thereafter|Treated Set (TS). TS consisted of all patients who received at least one dose of trial medication.|||percentage of patients|||Number
1464158|NCT00748709|Secondary|Maximum CTCAE Grade|Patients with AEs by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
1464159|NCT00748709|Secondary|Patients With AEs Resulting in Dose Reduction or Treatment Discontinuation|Patients with adverse events (AEs) resulting in dose reduction or treatment discontinuation|First administration of trial medication until 28 days after last administration of trial medication|TS|||Participants|||Number
1464360|NCT00746889|Primary|Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 4 weeks|This population was defined as patients who completed the 4 week follow up assessment as per protocol.|||units on a scale||Standard Deviation|Mean
1464160|NCT00748709|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the start of treatment to the occurrence of disease progression or death, whichever came first. Disease progression was assessed according to RECIST 1.0 criteria as well as by the investigators assessment, progression date recorded from post trial follow up or start of new anticancer treatment.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for PFS.||||||
1464161|NCT00748709|Secondary|Duration of OR|Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock.|Trial terminated early, therefore no data summaries produced for duration of OR.||||||
1464162|NCT00748709|Secondary|Time to Objective Response (OR)|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|Trial terminated early, therefore no data summaries produced for time to OR.||||||
1464163|NCT00748709|Secondary|Percentage of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST 1.0 criteria.|Tumour assessments were performed at screening, week 6, week 12, and every 8 weeks till database lock|TS.|||percentage of patients|||Number
1464164|NCT00748657|Secondary|Number of Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0|Adverse Events at least possibly related to study agent.|Up to 5 years|Eligible and evaluable patients|||Participants|||Count of Participants
1464165|NCT00748657|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||Months||95% Confidence Interval|Median
1464166|NCT00748657|Secondary|Progression-free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1464167|NCT00748657|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels|Eligible and Treated Patients|||percentage of patients||90% Confidence Interval|Number
1464168|NCT00748579|Secondary|Effects of CK-1827452 on Ventricular Performance, Myocardial Oxygen Consumption, Pressure-volume Relationships, Systolic Ejection Time and Invasively Measured Hemodynamics, Including Filling Pressures and Cardiac Output.||1 day|||||||
1464169|NCT00748579|Primary|Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.|Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.|1 day|Study was terminated due to poor enrollment; 2 participants completed the study. Data quantity was insufficient to analyze or draw conclusions.||||||
1464170|NCT00748566|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of “Yes” on “actual attempt”), preparatory acts toward imminent suicidal behavior(3)(“Yes” on “preparatory acts or behavior”), suicidal ideation(4) (“Yes” on “wish to be dead”, “non-specific active suicidal thoughts”, “active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(“Yes” on “Has subject engaged in non-suicidal self-injurious behavior”).|Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52|Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.||||||
1464171|NCT00748566|Secondary|Changes From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1464172|NCT00748566|Secondary|Change From Baseline in European Quality of Life (EuroQoL) – 5 Dimensions Index (EQ-I) Score at Week 28 and 52|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state."|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1464173|NCT00748566|Secondary|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52|SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1464174|NCT00748566|Secondary|Change From Baseline in Drug-Attitude Inventory–30-Item Scale (DAI-30) Score at Week 28 and 52|DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1464175|NCT00748566|Secondary|Clinical Global Impression-Improvement (CGI-I) Scale Score|CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.|Endpoint (premature discontinuation or Week 52)|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1464176|NCT00748566|Secondary|Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52|CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1464177|NCT00748566|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52|Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.|Baseline, Week 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
1464178|NCT00748566|Secondary|Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52|QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate).|Baseline, Week 4, 12, 28, 52|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure. Missing values at Week 52 were imputed using LOCF. N (number of participants analyzed)=participants evaluable for this measure. n=evaluable participants at specified time points.|||milliseconds||Standard Deviation|Mean
1464179|NCT00748566|Secondary|Change From Baseline in the Physical Activity Index Score at Week 28 and 52|Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity.|Baseline, Week 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
1464180|NCT00748566|Secondary|Change From Baseline in Insulin Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values were imputed using LOCF at Week 52. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||international unit per liter (IU/L)||Standard Deviation|Mean
1464181|NCT00748566|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of total hemoglobin||Standard Deviation|Mean
1464182|NCT00748566|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52|Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||kg/m^2||Standard Deviation|Mean
1464183|NCT00748566|Secondary|Change From Baseline in Weight at Week 4,12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||kilogram (kg)||Standard Deviation|Mean
1464184|NCT00748566|Secondary|Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mmol/L||Standard Deviation|Mean
1464210|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 3 years after implants have been loaded|Population includes subjects who completed 36 month visit.|||Percentage of implants|Participants||Number
1464185|NCT00748566|Secondary|Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52|Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.|||percent of 10-year CHD risk||Standard Deviation|Mean
1464186|NCT00748566|Secondary|Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52||Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mg/dL||Standard Deviation|Mean
1464187|NCT00748566|Secondary|Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52|Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mg/dL||Standard Deviation|Mean
1464188|NCT00748566|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52|BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||mmHg||Standard Deviation|Mean
1464189|NCT00748566|Secondary|Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52|Waist circumference data is reported separately for male and female participants.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||cm||Standard Deviation|Mean
1464190|NCT00748566|Secondary|Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of participants||95% Confidence Interval|Number
1464191|NCT00748566|Secondary|Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||participants|||Number
1464192|NCT00748566|Secondary|Percentage of Participants With Metabolic Syndrome (MS)|According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||percentage of participants||95% Confidence Interval|Number
1464193|NCT00748566|Secondary|Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52|MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.|Baseline, Week 4, 12, 28, 52|PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.|||risk factors||Standard Deviation|Mean
1464194|NCT00748566|Primary|Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)|MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.|Endpoint (premature discontinuation or Week 52)|Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants||95% Confidence Interval|Number
1464195|NCT00748553|Secondary|Progression-free Survival|Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.|2 years|Data were not collected.||||||
1464196|NCT00748553|Secondary|Number of Participants With ER+ Status|Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).|2 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity. Thirteen patients were evaluated for ER+ status.|||participants were ER+|||Number
1464197|NCT00748553|Primary|Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria|"Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized.~For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|1.5 years|Of the 14 patients enrolled on the Phase II portion of trial, one patient opted out off trial after 1 cycle because of toxicity.|||percentage of participants||95% Confidence Interval|Number
1464198|NCT00748553|Primary|Phase I: Percentage of Participants Responding to Treatment|Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.|6 months|16 patients were evaluable for toxicity. 13 were evaluable for response per RECIST v1.|||percent of participants with response||95% Confidence Interval|Number
1464199|NCT00748540|Secondary|Residual Hearing in Patients Implanted With Vibrant Soundbridge|Unaided hearing thresholds measured at the 10 month interval compared to the preoperative interval in order to assess any changes|10 months post initial activation||||Participants|||Count of Participants
1464200|NCT00748540|Secondary|Speech Perception in Noise (HINT Sentences) in Patients Implanted With Vibrant Soundbridge.|Signal to Noise Ratio for sentences at the preoperative interval compared to the 6 month interval.|6 months post initial activation|3 subjects did not completed this testing due to limitations of the equipment used.|||Signal to Noise Ratio||Standard Deviation|Mean
1464201|NCT00748540|Secondary|Functional Gain Compared to Preoperative Unaided Condition in Patients Implanted With Vibrant Soundbridge.|Auditory thresholds in the soundfield at the preoperative interval compared to the 6 month postoperative interval.|6 months post initial activation||||Participants|||Count of Participants
1464202|NCT00748540|Primary|Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge|Percent correct on words in quiet at the preoperative interval compared to 6 month post operative interval.|6 months post initial activation||||percentage of words correct||Standard Deviation|Mean
1464203|NCT00748410|Secondary|Amount of Medicine in Blood|Blood samples were collected at 1, 2.25, 4, 8 hour on Day 1 and 7 for the analysis of amount of medicine in blood. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|At 1, 2.25, 4, 8 hour on Day 1 and 7|All subjects population.|||nanogram per hour (ng/hr)|||Number
1464204|NCT00748410|Secondary|Changes From Baseline to After Treatment in Faecal Calprotectin Levels|Stool sample was collected from 1-hour post dose until 8 hours post dose for faecal calprotectin measures. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.|Day -1 and pre-dose and 8 hour post-dose on Day 1 and 7|All subjects population.|||milligram per litre (mg/L)|||Number
1464205|NCT00748410|Secondary|Vital Signs Assessment- Heart Rate|Vital sign measurements included heart rate at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|Day 1 and 7|All subjects population. Only those participants with data available at the specified time points were analyzed.|||beats per minute (bpm)|||Number
1464206|NCT00748410|Secondary|Vital Signs Assessment- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements included SBP and DBP at Day 1 and 7. Data was collected in supine position. It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done.|Day 1 and 7|All subject population. Only those participants with data available at the specified time points were analyzed.|||millimeter of mercury (mmHg)|||Number
1464207|NCT00748410|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up (7 to 10 days after last dose)|All subject population.|||Participants|||Count of Participants
1464208|NCT00748410|Primary|Change From Baseline at 1 and 7 Days Treatment With Daily Dose of SB-656933-AAA in 99m(Technetium-hexamethyl Derivative of Propylene Amine Oxide)Tc-HMPAO Leukocyte Single Photon Emission Computerized Tomography (SPECT) Scintigraphic Activity Scores (SAS)|Data has been presented for participants since change from Baseline data was not analyzed. For scintigraphy, blood was obtained for radiolabelling. Labelled white cells were then injected for SPECT scintigraphy and scanning began 45 minutes after injection of labelled White blood cells (WBCs). SPECT images of the colon were divided into 5 segments: ascending colon, transverse colon, descending colon, sigmoid, and rectum.T he SPECT segment uptake ratio was expressed as a fraction of bone marrow activity obtained from counts in the lumbar spine. The SPECT segment uptake ratio was converted into a four-point (0 to 3) segmental SPECT severity score where grade 0 was equal to no uptake. Only 3 participants were included before the study was discontinued.It was not possible to draw any meaningful conclusions from the very limited data available. Data has been presented for the 3 participants (99001, 99002 and 99003) since the analysis was not done. Baseline was Day -1.|Baseline (Day -1) and Day 1 and 7|The ‘All Subjects population’ was defined as all participants who received at least one dose of study medication. Only those participants with data available at the specified time points were analyzed.|||Score on scale|||Number
1464380|NCT00746733|Secondary|Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population|||bpm||Standard Deviation|Mean
1464211|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 2 years after implants have been loaded|Population includes subjects who completed 24 month visit.|||Percentage of implants|Participants||Number
1464212|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 1 year after implants have been loaded|Population includes subjects who completed 12 month visit.|||Percentage of implants|Participants||Number
1464213|NCT00748241|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.|At follow-up visit: 6 months after implants have been loaded|Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).|||Percentage of implants|Participants||Number
1464214|NCT00748189|Secondary|Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Gram per liter||Standard Deviation|Mean
1464215|NCT00748189|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1464216|NCT00748189|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1464217|NCT00748189|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented by treatment cycle. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1464218|NCT00748189|Secondary|Number of Participants With AEs and SAEs of Maximum Severity of Grade 3 or Higher|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Maximum severity grades were evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1464219|NCT00748189|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)|Safety Population|||Participants|||Number
1464280|NCT00747643|Secondary|A Measure of the Subjective Expected Value of a Cigarette|The cigarette choice procedure (Kidorf, Stitzer, and Griffiths, 1995) is a measure of the desire to smoke a cigarette. Participants are asked to hypothetically choose between smoking a cigarette now or receiving a small amount of money (from 10 cents up to $6 in increments of 10 cents). A crossover ($) value, at and above which participants prefer money, is obtained (Reid, Palmar, Raghavan, and Flammino, 2007).|3 weeks per participant|Per Protocol|||Dollars||Standard Error|Mean
1464381|NCT00746733|Secondary|Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population|||mmHg||Standard Deviation|Mean
1464220|NCT00748189|Secondary|Change From Baseline in Health Related Quality of Life (HRQOL)|HRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQC30), Chronic Lymphocytic Leukemia module (EORTC QLQ-CLL16), EuorQoL-Five Dimension (EQ-5D), and HCQ. Period (P)1 (Day 85, Day 169, Day 253) and P2 (scheduled follow-up (FU) and withdrawal visits) analysis were considered. Baseline (BL) for P1 was defined as score from screening visit and BL for P2 was defined as the last on-treatment score. The 2 principal QoL outcomes were pre-specified as the Global Health scale (GHS/QOL) of the EORTC QLQ-C30 and fatigue scale of the EORTC QLQ-CLL16. For EORTC QLQ-C30,GHS/Qol, the possible scale range was 0-100 (with 100 being 'best') and a positive difference from BL is indicative of better functioning (range -100 to +100). For the EORTC QLQ-CLL16 fatigue scale, the possible scale range was 0-100 (with 0 being 'best') and a negative difference from BL represents an improvement in fatigue (range -100 to +100).|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
1464221|NCT00748189|Secondary|Dose-normalized AUC(0-6) and AUC(0-inf) of Chlorambucil and Dose-normalized AUC(0-6) of Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The area under the plasma concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) and over 6 hours (AUC[0-6]) of chlorambucil and AUC(0-6) of PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.|||Hours*nanogram/milliliter/milligram||Standard Deviation|Geometric Mean
1464222|NCT00748189|Secondary|Dose-normalized Cmax of Chlorambucil and Phenylacetic Acid Mustard (PAAM)|Blood samples for the determination of serum concentrations of chlorambucil and its metabolite PAAM were collected from participants in a substudy on Cycle 3 Day 1. The maximum observed concentration (Cmax) of chlorambucil and PAAM normalized to the administered dose was determined as a measure of exposure and compared to reference data from a prior study (LEUA1001) [No NCT number available for this study; GlaxoSmithKline Document Number RM1998/00449/00].|Cycle 3 Day 1|Chlorambucil/PAAM pharmacokinetic (PK) Population (substudy): all participants for whom a chlorambucil/PAAM sample is obtained and analyzed.|||nanograms per milliliter per milligram||Standard Deviation|Geometric Mean
1464223|NCT00748189|Secondary|Plasma Half Life (t1/2) of Ofatumumab|The terminal half-life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original concentration. Blood samples were collected to assess the plasma half-life of ofatumumab. Blood samples were collected from participants who received ofatumumab plus chlorambucil pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population|||hours||Geometric Coefficient of Variation|Geometric Mean
1464224|NCT00748189|Secondary|Vss of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Blood samples were collected from participants who received ofatumumab plus chlorambucil at predose and 0.5 hour after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of the treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."|||Liters||Geometric Coefficient of Variation|Geometric Mean
1464225|NCT00748189|Secondary|AUC(0-tau) of Ofatumumab|Area under the concentration time curve over the dosing interval [AUC(0-tau)] is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the ofatumumab plasma concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of ofatumumab. For estimation of AUC(0-tau), blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hous after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1|"PK Population. Only those participants available at the indicated time points were assessed. The number of participants assessed at each time point is indicated by n=X,X."|||µg x hours/mL||Geometric Coefficient of Variation|Geometric Mean
1464226|NCT00748189|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to the ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on duration of treatment. Samples were also collected during clinic visits on Day 15 (during Cycle 1) and Day 43 (during Cycle 2) and at 1, 3, and 6 months post-treatment.|Cycle 4 Day 1|PK Population.|||Milliliter/hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1464281|NCT00747643|Primary|Cue-provoked Cravings|"Strength of Craving 0 (lowest) to 20 (highest). One item 0 - 20 Likert scale How strong was your craving to smoke a cigarette?"|3 weeks per participant|Per Protocol|||Scores on a scale||Standard Error|Mean
1464282|NCT00747643|Secondary|Smoking Topography - Number of Puffs on a Cigarette|# Puffs = total number of puffs taken at Assessment Session.|3 weeks per participant|Per Protocol|||Puffs on a Cigarette||Standard Error|Mean
1464227|NCT00748189|Secondary|Cmax and Ctrough of Ofatumumab|Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected from participants who received ofatumumab plus chlorambucil at pre-dose and 0.5 hours after the end of the ofatumumab infusion at treatment Cycle 1 and Cycle 4 (Days 1, 8, and 85). In addition, pre-dose samples were collected prior to ofatumumab administration at Cycles 2, 3, 5, 6, 9 and 12 (Days 29, 57, 113, 141, 225 and 309), depending on the duration of treatment.|Cycle 1 Day 1,Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, and Cycle 9 Day 1|Pharmacokinetic (PK) Population: all participants for whom a pharmacokinetic sample was obtained and analyzed.|||Micrograms/Milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1464228|NCT00748189|Secondary|Number of Participants With a Human Anti-human Antibody (HAHA) Positive Result|Serum samples for analysis of HAHA were collected at Baseline (Screening), Cycle 4 Day 1 (after 3 months of treatment), and at 1 month and 6 months post last dose of ofatumumab. All samples were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA-positive and further evaluated in the titration test to obtain a titer of HAHA.|Baseline, Cycle 4 Day 1, 1 Month Follow-up, and 6 Month Follow-up|Safety population: all participants who received at least 1 dose of a study drug. Only participants with post-ofatumumab HAHA Results are included.|||Participants|||Number
1464229|NCT00748189|Secondary|Number of Participants With Improvement in Constitutional Symptoms (CS)|Assessment for the presence of the following symptoms were performed at Screening, Day 1 of each treatment cycle and at every Follow-up visit: night sweats (without signs of infection); unexplained, unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of greater than 38 degrees celsius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue. The best response refers to overall best response in terms of CR, CRi, PR or nPR. Data are presented for constitutional response= yes and no.|Baseline, Cycle 3 Day 1, and 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1464230|NCT00748189|Secondary|Number of Participants With Improvement in ECOG Performance Status of 0 or 1, as Assessed by the IRC|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, how the disease affects the daily living, and determines appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead. Participants with an ECOG performance status of 0 or 1 are shown..|Baseline, Cycle 3 Day 1, 1 month Follow-up|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
1464231|NCT00748189|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from randomization until the start of the next-line of treatment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
1464232|NCT00748189|Secondary|Time to Progression, as Assessed by the IRC|Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
1464233|NCT00748189|Secondary|Duration of Response (DOR), as Assessed by the IRC|DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.|||Months||95% Confidence Interval|Median
1464283|NCT00747643|Primary|Tonic Craving Score (QSU) Based on Self Reports|Tonic Craving 1 (lowest) to 7 (highest). The Questionnaire of Smoking Urges (QSU), our primary measure of tonic craving, is a 32-item instrument, including 2 separate factor scales that roughly correspond to the desire to smoke for its pleasurable effects (positive reinforcement) or to remove unpleasant feelings of negative affect or withdrawal (negative reinforcement) (Tiffany and Drobes 1991). Following overnight abstinence, each session included assessment of tonic craving, reactivity (including craving) to smoking cues.|3 weeks per participant|Per Protocol|||Scores on a scale||Standard Error|Mean
1464234|NCT00748189|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from randomization to the first response (CR, CRi, nPR, or PR). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders. Only responders (CR, CRi, PR, nPR) were included in the analysis.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Time to response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.|||Months||95% Confidence Interval|Median
1464235|NCT00748189|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death due to any cause. Each participant was followed at the time when the total IRC-assessed PFS events occurred. Participants who had not died were censored at the date of last contact.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Months||95% Confidence Interval|Median
1464236|NCT00748189|Secondary|Number of Participants Who Were Negative for Minimal Residual Disease (MRD)|MRD was performed by flow cytometry on a bone marrow or peripheral blood sample taken at least 2 months after final treatment. MRD negative was defined as less than one CLL cell per 10000 leukocytes.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
1464237|NCT00748189|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the IRC|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]). CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|ITT population. Only those participants with data available at the indicated time points were analyzed. OR was according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.|||Participants|||Number
1464238|NCT00748189|Primary|Progression-Free Survival (PFS), as Assessed by the Independent Review Committee (IRC)|PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)|Intent-to-Treat (ITT) Population: all par. randomized to study treatment regardless of whether or not they received treatment. PFS was assessed by a blinded independent review committee according to the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines.|||Months||95% Confidence Interval|Median
1464239|NCT00748098|Secondary|Number of Participants Who Self-reported “Very Satisfied” or “Satisfied” With the Investigational Product at Week 4/10 Using LOCF|"Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study. The participant responses ranged from 1 (Very satisfied) to 7 (Very dissatisfied). A satisfied response was scored a 2."|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
1464240|NCT00748098|Secondary|"Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF"|The CGI-I scale allows the investigator to rate the participant’s global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 (“Very much improved”) or 2 (“Much improved”) are considered to be responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
1464284|NCT00747617|Secondary|Serum Testosterone Responses to hCG||-0.5, 0, 0.5, 24 hrs|||||||
1464285|NCT00747617|Primary|Serum 17OHP Responses to hCG|Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects|24 hrs post dose|PCOS and Normal groups were analyzed according to peak 17OHP levels at each dose of r-hCG.|||ng/ml||Standard Error|Mean
1464382|NCT00746733|Primary|Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1464241|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness – Severity (CGI-S) Score at Week 4/10 Using LOCF|The CGI-S scale allows the investigator to rate the severity of participants’ illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1464242|NCT00748098|Secondary|Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF|"Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant’s subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: “Helped me sleep,” Helped me fall asleep faster,” “Helped me sleep longer,” and “Helped me get a better night’s sleep.”"|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||participants|||Number
1464243|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1464244|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10|During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete data.|||number of PLMs per hour||Standard Error|Least Squares Mean
1464245|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.|Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1464246|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes/hour||Standard Error|Least Squares Mean
1464247|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF|Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1464248|NCT00748098|Secondary|Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||participants|||Number
1464334|NCT00747149|Secondary|Percentage of Subjects Achieving Total Cholesterol (TC)/ High-density Lipoprotein Cholesterol (HDLC) Ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 Weeks of Treatment|Proportion of subjects achieving total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC) ratio (i.e. TC/HDL < 4.0 mmol/L) at 6 and 12 weeks of treatment|6 and 12 Weeks|||||||
1464249|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF|Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||hours||Standard Error|Least Squares Mean
1464250|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF|The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||awakenings||Standard Error|Least Squares Mean
1464251|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Participant’s Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.|Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||scores on a scale||Standard Error|Least Squares Mean
1464252|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF|Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: The number of participants assessed varied due to missing/incomplete diary data.|||scores on a scale||Standard Error|Least Squares Mean
1464253|NCT00748098|Secondary|Number of PLMAI Responders at Week 4/10 Using LOCF|PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders.|Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||participants|||Number
1464254|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||number of PLMs/total hours of sleep||Standard Error|Least Squares Mean
1464255|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10|Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1464256|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF|In REM sleep, a participant’s breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1506855|NCT00422422|Primary|Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years||Day 21||||ug/mL||Standard Deviation|Mean
1464257|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10|Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1464258|NCT00748098|Secondary|Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF|Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1464259|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10|Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1464260|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF|In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1464261|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF|Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||percentage of total sleep time||Standard Error|Least Squares Mean
1464262|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF|Stage N1 is considered “light sleep,” during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as “somnolence” or “drowsy sleep.” Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1464263|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF|"The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: In the past week, how severe was your sleep disturbance due to your RLS symptoms?. The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1464286|NCT00747565|Primary|Mean Binocular Distance Corrected Near Visual Acuity in Snellen|Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.|One year|Binocular subjects at one year available for testing for both studies combined.|||Mean Snellen Line (with ETDRS line SD)||Standard Deviation|Mean
1465565|NCT00736099|Secondary|Change in HbA1c From Baseline to Week 6||Baseline and week 6|Treated Set with values for HbA1c at baseline and week 6. Values after rescue therapy are set to missing.|||percent||Standard Deviation|Mean
1464264|NCT00748098|Secondary|Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF|The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants’ mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. An additional 4 participants (2 in each treatment group) were excluded from the analysis due to missing/incomplete data.|||scores on a scale||Standard Error|Least Squares Mean
1464265|NCT00748098|Secondary|Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF|PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||limb movements per hour||Standard Error|Least Squares Mean
1464266|NCT00748098|Primary|Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)|"PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a sleep study that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects."|Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)|ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.|||minutes||Standard Error|Least Squares Mean
1464267|NCT00748085|Secondary|Consists of a Measure of Treatment Efficacy and Improvement in Luminal Patency Assessed by Visual Inspection.||1 year|no analysis conducted. Study terminated for business reasons||||||
1464268|NCT00748085|Primary|Efficacy of the Cryogen on a Tumor Evaluated by Histopathological Data and Visual Inspection Along With Visual Confirmation of Absence of Scarring and Stricturing of the Airway. The Primary Safety Endpoint is the Reporting of All Adverse Events.||1 year|no analysis conducted-study terminated for business reasons||||||
1464269|NCT00748072|Primary|The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.||Immediately post-biopsy and 24 hours post-biopsy.||||participants|||Number
1464270|NCT00747916|Secondary|To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent.||1 year|zero participants analyzed due to early termination of study||||||
1464271|NCT00747916|Primary|To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.||1 year|zero participants analyzed due to early termination of study||||||
1464272|NCT00747812|Primary|Number of Days With 4 or More Hours of Headache||12 Weeks||||Days||Standard Deviation|Mean
1464273|NCT00747812|Primary|Number of Hours of Headache||12 weeks||||Hours||Standard Deviation|Mean
1464274|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After two weeks||||percentage of patients|||Number
1464275|NCT00747747|Secondary|Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)|Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.|After one week|Eligibility according to in/ex criteria and compliance with study requirements|||percentage of patients|||Number
1464276|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)|After two weeks||||percentage of patients|||Number
1464277|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups."|After two weeks||||percentage of patients|||Number
1464278|NCT00747747|Secondary|FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject|"Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank 0 were compared as outcome measure between groups"|After one week|Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements|||percentage of patients|||Number
1464279|NCT00747747|Primary|Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)|Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)|After one week|The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements.|||percentage of patients|||Number
1464331|NCT00747149|Secondary|Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy||6 and 12 Weeks|||||||
1464287|NCT00747565|Primary|Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.|"Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,first eye refers to the first implanted eye of each subject."|One year|First eye results from subjects at one year in both the original study and the expansion study combined.|||Participants (First Eyes only)|||Number
1464288|NCT00747552|Secondary|Median Bladder Pressure for All Measurements|Intra-abdominal Pressure (IAP) measurements will be tabulated and frequency distributions determined for patients with and without any clinical/surgical abdominal pathology. Median and quartile values will be assessed in order to describe normative values. In patients with clinical abdominal pathology (abdominal distention, necrotizing enterocolitis, abdominal wall defects, diaphragmatic hernia, etc), sequential evaluation of IAP will be done to try to identify thresholds for Intra-abdominal Hypertension (IAH).|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.|||mmHg||Inter-Quartile Range|Median
1464289|NCT00747552|Primary|Intra-abdominal Pressure(IAP) Measurements in NICU Patients.|Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.|3 years|18 of the neonates required staged abdominal surgery for various abdominal abnormalities or disease, while 12 of the neonates were ill due to PPHN, sepsis, or hydrops. All analysis was per protocol.|||IAP measurements|||Number
1464290|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464291|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464292|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464293|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464294|NCT00747474|Primary|Plasma Decay Half-Life (t1/2) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464295|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1464296|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1464297|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1464298|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1464299|NCT00747474|Primary|Dose-normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
1464300|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464332|NCT00747149|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12||6 and 12 Weeks|||||||
1504861|NCT00435188|Secondary|Self Rated Health|Self-report of overall health, reported as the number of participants reporting health as Excellent or Very good|Baseline||||participants|||Number
1464301|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464302|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464303|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464304|NCT00747474|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||hour||Standard Deviation|Mean
1464305|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U2|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1h, 1h30m, 2h, 4h, 8h|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1464306|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of TLC-U1|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1464307|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of Topotecan|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1464308|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,S-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1464309|NCT00747474|Primary|Maximum Observed Dose-normalized Plasma Concentration (Cmax) of S,R-TLC388|Drug product Lipotecan consists of TLC388 diastereomers (S,S-TLC388 and S,R-TLC388 in 2:1 ratio). Three metabolites as TLC-U1, TLC-U2 and topotecan were identified in rats, dogs and human.|0, 15m, 29m, 33m, 40m, 50m, 1 h, 1h 30m, 2h, 4h, 8h post-dose|Patients complete cycle 1 and 2 treatments without major protocol deviation.|||ng/mL||Standard Deviation|Mean
1464310|NCT00747474|Primary|Number of Participants With Adverse Events|Number of participants with AEs that occurred during treatment and follow-up period (30 days after last treatment). Drug-related AEs and SAEs were followed until resolved or stabilized. AEs were classified by the investigator according to severity graded using CTCAE version 3.0 and relationship to study drug. The severity scale is: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to AE|an average of 6 months|Patients received at least one dose of Lipotecan|||participants|||Number
1464311|NCT00747474|Secondary|Anti-tumor Activity|Patients were evaluated by tumor assessment using RECIST guidelines. Possible evaluations include: Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the size of target lesions. Progressive Disease (PD): at least a 20% increase in the size of target lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|From start of treatment assessed every 2 cycles up to 2.5 years|Patients received at least one dose of Lipotecan.|||participants|||Number
1464312|NCT00747474|Primary|Maximum Tolerated Dose (MTD) of Lipotecan|MTD is the highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT)). A 3+3 study design was used to determine MTD. The MTD was the highest dose level at which 0 of 3 or 1 of 6 patients experience a DLT, with the next higher dose having at least 2 of 3 or 2 of 6 patients experiencing a DLT.|First treatment to toxicity up to 42 days|Patients received at least one dose of Lipotecan.|||mg/m^2|||Number
1464313|NCT00747461|Secondary|Treatment Durability|need for additional treatments within specified period|12 months|study terminated-no subjects analyzed.||||||
1464314|NCT00747461|Primary|Improvement in Luminal Patency Following Cryospray Treatment||30 days|study terminated by Sponsor-data not analyzed||||||
1464315|NCT00747435|Secondary|Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.|Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.|12 months post initial activation|Only 59 subjects completed the HDSS at preop and 12 month post activation.|||Participants|||Count of Participants
1464316|NCT00747435|Secondary|Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.|A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.|12 months post initial activation|Only 59 subjects completed the APHAB at preop and 12 months post activation.|||percentage of scoring change (APHAB)||Standard Deviation|Mean
1465825|NCT00734539|Secondary|Stage II or Higher Necrotizing Enterocolitis||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1464317|NCT00747435|Secondary|Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.|CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.|12 months post initial activation||||percentage of words correct (CNC)||Standard Deviation|Mean
1464318|NCT00747435|Secondary|Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.|12 months initial activation|One subject lost residual hearing immediately after surgery and was unable to use EAS. The subject was testing in cochlear implant alone condition.|||percentage of words correct (CUNY)||Standard Deviation|Mean
1464319|NCT00747435|Primary|Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.|CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.|12 months post initial activation|One subject lost residual hearing immediately following surgery and was unable to use EAS. This subject was tested with the cochlear implant alone and is not included in this analysis.|||percentage of words correct (CUNY)||Standard Deviation|Least Squares Mean
1464320|NCT00747344|Secondary|The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12|Scores could range from 0 to 30. A lower DLQI score represents better quality of life.|Baseline to Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Scores on a scale||Standard Deviation|Mean
1464321|NCT00747344|Secondary|The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12||Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Participants|||Number
1464322|NCT00747344|Primary|The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) at Week 12|PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).|Week 12|Participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they received.|||Participants|||Number
1464323|NCT00747227|Secondary|"Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as Good or Excellent."|"Subjects indicating a subjective response to a multiple choice question, At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?, on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit."|One Year|Two subjects in the ZV9003 group did not complete the one year questionnaire.|||participants|||Number
1464324|NCT00747227|Primary|Uncorrected Distance Visual Acuity|Snellen Equivalent of 20/40 or better at one year|One Year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.|||participants|||Number
1464325|NCT00747227|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|4-6 months|Binocular contrast sensitivity testing was reported for all binocular subjects with data available at the 4-6 month visit on 120 subjects in each group. One ZA9003 subject was tested at 3.0 cpd and not tested for 6.0 cpd through 18.0 cpd (mesopic and photopic). Testing for levels 6.0 through 18.0 were not reported.|||log contrast||90% Confidence Interval|Mean
1464326|NCT00747227|Primary|Best Corrected Distance Visual Acuity|Snellen Equivalent visual acuity of 20/40 or better|One year|One subject was excluded from the analysis because the ZV9003 lens was implanted in the first eye and the ZA900 lens was implanted in the second eye. All subjects in the outcomes analysis had the same lens in both eyes.|||participants|||Number
1464327|NCT00747214|Secondary|Change in Fatigue (MAF Scale) Score From Baseline to Day 42|"The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).~Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5~Sum items #1, 2, and 3~Average items #4 through 14~Add results from above Steps 1 through 3 to obtain a single score~A score was not be assigned to items #4 through 14 if a respondent indicated they did not engage any activity for reasons other than fatigue. If respondent selected “no fatigue” on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index."|Baseline and Day 42||||units on a scale||Standard Deviation|Mean
1464328|NCT00747214|Secondary|Change in DAS28 Score From Baseline to Day 42|To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit.|Baseline and Day 42||||units on a scale||Standard Deviation|Mean
1464329|NCT00747214|Secondary|Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)|The percentage of subjects in each group that achieved an ACR 20 response on Day 42|Day 42||||percentage of participants|||Number
1464330|NCT00747214|Primary|Change in CRP From Baseline to Day 42|The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.|Baseline and Day 42||||percentage change from baseline||Standard Deviation|Mean
1464335|NCT00747149|Primary|Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy|The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100|12 Weeks||||Percentage||95% Confidence Interval|Mean
1464336|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1464337|NCT00747006|Secondary|Lunch Plasma Glucose AOC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|Lunch area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1464338|NCT00747006|Secondary|Breakfast Plasma Glucose AOC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|Breakfast area over the plasma glucose - time curve from time 0 (immediately before breakfast) to 240 minutes after start of breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1464339|NCT00747006|Secondary|Lunch Plasma Glucose AOC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|Area over the plasma glucose - time curve from time 0 (immediately before starting lunch) to 240 minutes after the start of the lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1464340|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 (Humalog Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||mg/dL||Full Range|Mean
1464341|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Amendment 1 ( TI Treated Type 2 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax-Cmin) at lunch|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus TI Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||mg/dL||Full Range|Mean
1464342|NCT00747006|Primary|Breakfast Plasma Glucose Excursion - Original Protocol (TI Treated - Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at breakfast|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||mg/dL||Full Range|Mean
1464343|NCT00747006|Primary|Lunch Plasma Glucose Excursion - Original Protocol (TI Treated Type 1 Subjects)|Excursion is the difference between plasma glucose Cmax and Cmin (Cmax - Cmin) at lunch|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||mg/dL||Full Range|Mean
1464344|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (Humalog Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Humalog Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1464345|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC(0-240) - Amendment 1 (TI Treated Type 2 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Protocol Amendment 1 Type 2 Diabetes Mellitus Technosphere Insulin Treated Subjects; 150% carbohydrate load was not done per protocol since the 200% carbohydrate load was administered|||min*mg/dL||Full Range|Mean
1464346|NCT00747006|Primary|Breakfast Plasma Glucose Time 0 Corrected AUC(0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1464347|NCT00747006|Primary|Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)|"AUC (area under the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is above time 0 value.~AOC (area over the plasma glucose - time curve) from time 0 (immediately before starting meal) to 240 minutes after the start of the meal when the curve is below time 0 value.~TIme 0 corrected AUC (0-240) = AUC - AOC"|0 to 240 minutes|Original Protocol Type 1 Diabetes Mellitus Technosphere Insulin Treated; 50% carbohydrate load was administered but not completed due to all subjects having hypoglycemia, 0% carbohydrate load was deemed unsafe by PI|||min*mg/dL||Full Range|Mean
1464348|NCT00746954|Primary|Apnea-hypopnea Index (Number of Central and Mixed Apneas/Hour of Sleep)||Overnight polysomnogram over 3 separate nights|Comparisons among Drugs (not Arms)|||APNEA-HYPOPNEA/HR by drug or placebo||Standard Deviation|Mean
1464359|NCT00746889|Other Pre-specified|Change in WOMAC Pain Subscale|WOMAC pain subscale range 0-20 (0=best, 20=worst)|baseline to 12 weeks|These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group.|||units on a scale||Standard Deviation|Mean
1464349|NCT00746941|Secondary|Participants Who Died Within 6 Months|The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen.|Day 1 up to 6 months|"Safety population: All participants who enrolled in the study and were dosed, and who have at least 1 post-baseline safety assessment.~The death event is counted under the treatment arm relative to adding mefloquine to the treatment regimen."|||participants|||Number
1464350|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||log10 mm^3||Standard Deviation|Mean
1464351|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||log10 mm^3||Standard Deviation|Mean
1464352|NCT00746941|Secondary|Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains||Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||participants|||Number
1464353|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS)|"Participants rate their neurological function on a scale of 100 mm line, where the 0 end of the scale indicates poor neurological function and 100 indicates excellent neurological function. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. VAS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1464354|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT)|"The SDMT is a simple substitution task. The test gives participants 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The total score is the total number of correctly completed boxes in the time allowed. The test score range is from 0 (worst outcome) to 110 (best outcome).~Negative change from baseline scores indicates a worsening outcome."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. SDMT was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1464355|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score|"The KPS Index classifies participants' functional impairment. KPS can be used to compare effectiveness of different therapies and to assess the prognosis in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the KPS score, the worse the survival for most serious illnesses. The KPS index is subdivided into 3 categories: incapacitated (0 to 40), self-care (50 to 70), and normal activity (80 to 100).~Negative change from baseline scores indicate improved prognosis."|Day 0 (baseline), Week 4, Week 8|"Participants with values at the time frames being measured. Participants with undetectable CSF JCV load at baseline by the central laboratory were not included in the efficacy analysis.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1464356|NCT00746941|Secondary|Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score|EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death) was calculated. Negative change scores indicate improvement.|Day 0 (baseline), Week 4 and 8|"Participants with values at the time frames being measured. EDSS was not required for participants who had physical or cognitive impairments that limited their ability to perform the assessment.~Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms."|||units on a scale||Standard Deviation|Mean
1464357|NCT00746941|Primary|Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 8 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 8|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 8 were available."|||log10 copies/mL||Standard Deviation|Mean
1464358|NCT00746941|Primary|Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)|"Change from baseline to Week 4 in JC viral load in CSF is expressed as log10 copies/mL. Negative values indicate a reduction in viral load.~Only participants with measurable baseline values are included. Post-baseline values of 'Below the Limit of Quantification' or 'Below Limit of Detection' or 'Negative' were set to 50. Log10 (50) = 1.699"|Day 0 (baseline), Week 4|"Local standard of care participants who added mefloquine at Week 4 or Week 8 were counted as being dosed under both treatment arms.~Participants with undetectable CSF JCV load at baseline were not included in the efficacy analysis. All other enrolled participants were included in the efficacy analysis if values for Week 4 were available."|||log10 copies/mL||Standard Deviation|Mean
1464361|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.|At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|24 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.|||cm||Standard Deviation|Mean
1464362|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.|At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|6 hours postoperative from mid-urethral sling placement|Intention to treat|||cm||Standard Deviation|Mean
1464363|NCT00746863|Secondary|Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.|Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.|From after surgery to discharge from hospital.||||participants w/sucessful voiding trial|||Number
1464364|NCT00746863|Secondary|In-hospital Medication Amounts|Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.|From surgery until discharge, average||||number of pills||Standard Deviation|Mean
1464365|NCT00746863|Primary|Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.|At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented “no pain” and 10 represented the” worst pain ever”.|2 hours postoperative from mid-urethral sling placement|Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.|||cm||Standard Deviation|Mean
1464366|NCT00746798|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.||Day 0 up to Day 14 post-vaccination|Safety assessments were on the Safety, intend-to-treat Population.|||Participants|||Number
1464367|NCT00746798|Primary|Number of Participants With Seroconversion Following Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|"Antibodies to vaccine were measured by the Plaque Reduction Neutralization Test.~Seroconversion was defined as a four-fold or greater rise in titer between pre- and post-injection samples; or a post-vaccination (Day 28) titers of ≥ 1:20 in participants with baseline titer ≤ 1:10."|Day 0 and Day 28 post-vaccination|Serum antibody levels and seroconversion were assessed in the per-protocol population.|||Participants|||Number
1464368|NCT00746798|Secondary|Number of Participants Developing Viremia After Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine.|Viremia is defined as number of subjects in the analysis population dose group with detected (≥ 20 Plaque forming units [pfu]/mL) viremia at the reported visit.|Day 2 up to Day 14 post-vaccination|Viremia concentrations were assessed in a randomly selected subset of the per-protocol population.|||Participants|||Number
1464369|NCT00746798|Primary|Geometric Mean Titers (GMTs) of Antibodies to Vaccination With ChimeriVax™ WN02 or a Placebo Vaccine|Antibodies to the vaccine antigens were measured by the Plaque Reduction Neutralization Test.|Day 0 and Day 28 post-vaccination|Serum antibody levels were assessed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1464370|NCT00746785|Primary|Drinks Per Drinking Day|"Drinks are measured as the number of standard alcoholic beverages consumed each day, assessed in varying lengths of time (i.e., 2 weeks, 4 weeks, 6 weeks, etc.). A standard alcoholic beverage is equivalent to: 1, 12 oz. regular beer; 1, 5 oz. glass of wine; 1, mixed drink with one1.5 oz shot; or 1, 1.5 oz shot. A drinking day is measured as any day of the week in which an alcoholic beverage is consumed. Data for drinks per drinking day is gathered using the Time Line Follow Back method in which participants are asked to recall their alcohol consumption day by day for a pre-defined set of time."|up to 36 weeks||||Drinks per drinking day||Standard Deviation|Mean
1464371|NCT00746733|Primary|T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1464372|NCT00746733|Primary|AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
1464373|NCT00746733|Primary|Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1464374|NCT00746733|Primary|Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|Total amphetamine is the d- and l-amphetamines.|0 through 96 hours after dosing|PK population|||ng/ml||Standard Deviation|Mean
1464375|NCT00746733|Primary|T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1464376|NCT00746733|Primary|AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC||0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
1464377|NCT00746733|Primary|Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1464378|NCT00746733|Primary|Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC|l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||ng/ml||Standard Deviation|Mean
1464379|NCT00746733|Secondary|Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.|Pre-dose, 2 and 8 hours after dosing|Safety population|||msec||Standard Deviation|Mean
1464383|NCT00746733|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||ng.h/ml||Standard Deviation|Mean
1464384|NCT00746733|Primary|Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|PK population|||h||Standard Deviation|Mean
1464385|NCT00746733|Secondary|Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC||Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing|Safety population defined as subjects who take at least one dose of investigational medicinal product and have at least one post-dose safety assessment.|||mmHg||Standard Deviation|Mean
1464386|NCT00746733|Secondary|DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population|||units on a scale||Standard Deviation|Mean
1464387|NCT00746733|Secondary|DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC|Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|PD population|||units on a scale||Standard Deviation|Mean
1464388|NCT00746733|Secondary|Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.|Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing|Pharmacodynamic (PD) population defined as all subjects who have evaluable DRQ-S values reported.|||units on a scale||Standard Deviation|Mean
1464389|NCT00746733|Primary|Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC|d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.|0 through 96 hours after dosing|Pharmacokinetic (PK) population defined as all subjects who have evaluable concentration-time profiles.|||ng/ml||Standard Deviation|Mean
1464390|NCT00746694|Primary|Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE|The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.|Participants will do a single visit, but cases will be collected during a period of 12 months.||||Participants|||Number
1464391|NCT00746694|Primary|Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)|"Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE.~Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it."|Participants will do a single visit, but cases will be collected during a period of 12 months.||||Participants|||Number
1464392|NCT00746668|Primary|Sentence Reading|To assess reading performance, after each training module (1-3), two lines of text were presented at the center of the monitor. Each subject was seated with his or her forehead on a head rest at a viewing distance of 40cm. The subject read each sentence aloud and indicated whether it made sense by responding true or false. Reading speed was calculated using an algorithm similar to that used for the MNRead test. The number of words read correctly was divided by the time required to read the sentence to yield a measure of reading speed in words per minute (wpm). Sentences were displayed at sizes of 0.1, 0.2, 0.3, 0.4, 0.5, and 0.6 log units above the subject's letter acuity threshold. Five sentences were presented at each font size. We used 105 different sentences so that no sentence was repeated for any subject. Average speed of reading (log wpm) was plotted as a function of font size (logMAR).|Pre-training, 6 weeks, 12 weeks, 18 weeks|Intent to Treat|||Words per Minute (wpm)||Standard Deviation|Mean
1464393|NCT00746590|Secondary|Changes in Laboratory Measurements||Baseline and every 3 weeks until progression|||||||
1464394|NCT00746590|Secondary|Adverse Events||Until progression|||||||
1464395|NCT00746590|Secondary|Changes in Alpha Fetoprotein||Baseline, every 3 weeks until progression|||||||
1464396|NCT00746590|Secondary|Post-treatment Changes in the Amount of Contrast-enhancing and Non-contrast-enhancing Tumour||Every 6 weeks until progression|||||||
1464397|NCT00746590|Secondary|Time to Tumour Progression||Every 3 weeks until progression|||||||
1464398|NCT00746590|Secondary|Disease Control Rate Defined as the Proportion of Subjects With Either Complete or Partial Response or Stable Disease||Approximately 12 weeks or more after first treatment with Prolarix|||||||
1464399|NCT00746590|Primary|Overall Best Tumor Response Rate (Proportion of Subjects With Complete or Partial Response) as Defined by Modified RECIST||every 6 weeks until progression|Study was terminated prematurely after only 1 patient was enrolled. The patient died one month after the initial dose of Prolarix, but his death was unrelated to Prolarix administration.|||participants||Standard Deviation|Mean
1464400|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase II|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.|6 weeks|All patients implanted with the SJM Confirm device in participating in Phase II. Total patients 36: (19 rollovers from Phase I enrollments)+(25 Phase II enrollments)-(1 withdrawal)-(7 subjects with no automatically triggered recordings). Total recordings obtained: 958|||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
1464401|NCT00746564|Other Pre-specified|Inappropriateness of Automatically Triggered Recordings – Phase I|The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes).|||percentage of inappropriate recordings|Participants|95% Confidence Interval|Number
1464402|NCT00746564|Other Pre-specified|Interpretability of Automatically Triggered/Symptom Driven Recordings|The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes). Total analyzable recordings 2804.|||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
1464403|NCT00746564|Other Pre-specified|Interpretability of Weekly Subject Activator Recordings|The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 30; 50-(1 withdrawal)-(19 patients who did not initiate recordings). Total analyzable recordings 58.|||percentage of interpretable recordings|Participants|95% Confidence Interval|Number
1464404|NCT00746564|Primary|Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers|The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 92: 96 obtained-(4 recordings with zero visible R waves)|||percentage of recordings|Participants|95% Confidence Interval|Number
1464405|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 45; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel)-(2 patients where no recording was obtained). Total analyzable recordings 45: 46 obtained-(1 recording with zero visible R waves).|||percentage of recordings|Participants|95% Confidence Interval|Number
1464406|NCT00746564|Primary|Positive Predictive Value (PPV) for In-Clinic Recordings at Rest|The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.|||percentage of recordings|Participants|95% Confidence Interval|Number
1464407|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings|||percentage of recordings|Participants|95% Confidence Interval|Number
1464408|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise|The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).|||percentage of recordings|Participants|95% Confidence Interval|Number
1464409|NCT00746564|Primary|Sensitivity for R Waves During In-Clinic Recordings at Rest|The sensitivity was calculated for each recording and for each subject.|6 weeks|50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).|||percentage of recordings|Participants|95% Confidence Interval|Number
1464410|NCT00746551|Secondary|Haemoglobin Level||3 weeks after intervention||||g/dL||Standard Deviation|Mean
1464411|NCT00746551|Primary|Serum Ferritin Level||3 weeks after intervention||||µg/dL||Standard Deviation|Mean
1464412|NCT00746512|Secondary|Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])|"The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) & swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale [VAS]), and the CRP (in mg/L measured from lab test). The scoring formula was:~DAS28(CRP) = 0.56*SQR(TJC28) + 0.28*SQR(SJC28) + 0.36*ln(CRP+1) + 0.014*GH(VAS) + 0.96.~Where SQR is square root and ln is natural log.~The formula produces a score from 0 to 10: >5.1 means high disease activity; <3.2 means low disease activity, <2.6 is generally considered remission."|Baseline and Day 14||||score on scale||Standard Deviation|Mean
1464413|NCT00746512|Primary|Synovial Blood Flow|Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.|Baseline and Day 14||||pixel count||Standard Deviation|Mean
1464424|NCT00746330|Secondary|Plasma Formoterol Concentrations (Pmol/L) Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in plasma was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for plasma was 1.45 pmol/L. No non-compartmental PK analysis was performed.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Because of the dosing periods where formoterol was present at concentrations greater than 5% of the Cmax data for 4 subjects was excluded. A dosing error resulted in the exclusion of 1 subject and 1 subject had all data excluded from PK evaluation due to the plasma drug concentrations in conflict with the recorded randomization.|||pmol/L||Standard Deviation|Mean
1464414|NCT00746421|Secondary|Brief Assessment of Cognition for Affective Disorders (BAC-A)|This is a series of neurocognitive tests and includes brief assessments of attention, motor speed, working memory, verbal memory, reasoning and problem solving, verbal fluency, affective interference, and emotion inhibition. The total BAC-A score is represented by a composite T-score which is dimensionless. This is computed by adding up the scores for each trial of a test domain (e.g. verbal memory) within the cognitive battery. Each test domain total is then inputted into a proprietary BAC-A calculator which determines the composite T-scores. A higher score indicates better performance. A study of 404 healthy adults demonstrated a mean composite score of 50 with a standard deviation of 10 (Keefe et al. Schizophrenia Bulletin. 2008; 102: 108-115).|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.|||units on a scale (composite t-score)||Standard Deviation|Mean
1464415|NCT00746421|Primary|The Continuous Performance Test-Identical Pairs Version|The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials.|6 weeks|The statistical analysis was planned as Intention to treat with LOCF as the endpoint variable. We initially aimed to enroll 50 patients per group but because the study was terminated early, with a total of only 32 subjects. These numbers are too small to have a meaningful statistical outcome and so this between group comparison was not performed.|||units on a scale||Standard Deviation|Mean
1464416|NCT00746395|Secondary|Small Bowel Transit|Small bowel transit time|Duration of the test - 8 hours|Patients without transit to cecum were excluded|||Minutes||Standard Error|Mean
1464417|NCT00746395|Primary|Complete Small Bowel Transit|Percent of subjects with capsule passage through small bowel|8 hours|Placebo 95%, lubiprostone 75%|||percentage of subjects with passage|||Number
1464418|NCT00746356|Primary|Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Left Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual threshold in the left ventricle were included in the analysis.|||Volts||Standard Deviation|Mean
1464419|NCT00746356|Primary|Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test|Right Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 43 CRT-D participants who successfully completed both an automatic and manual capture threshold in the right ventricle were included in this analysis.|||Volts||Standard Deviation|Mean
1464420|NCT00746356|Primary|Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Ventricular AutoCapture is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the ventricular pacing voltage until it determines that the device is no longer capturing the ventricles. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the ventricular pulse voltage and determines the ventricular threshold by viewing the EKG.|3 months post implant|Per protocol, the first 38 participants with an ICD who successfully completed both an automatic and manual capture threshold test were included in this analysis.|||Volts||Standard Deviation|Mean
1464421|NCT00746356|Primary|Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test|Atrial AutoCapture Confirm is an automatic test that the device performs without any interaction by the physician and is one of the features being evaluated in the study. The test temporarily decreases the atrial pacing voltage until it determines that the device is no longer capturing the atria. That value is reported to the physician when the device is read by the programmer. This endpoint looks at the absolute difference between this automated test and a manual test in which the physician decreases the atrial pulse voltage and determines the atrial threshold by viewing the EKG.|3 months post implant|Per protocol, the first 19 participants who successfully completed both an automatic and manual capture threshold test were included in this analysis.|||Volts||Standard Deviation|Mean
1464422|NCT00746356|Primary|Percentage of Participants Free of System-related Complications at 3-months Post Implant||3 months post implant||||Percentage of Participants|||Number
1464423|NCT00746330|Secondary|Urinary Excretion of Formoterol Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI)|Unchanged racemic formoterol in urine was assayed by LC-MS/MS. The lower limit of quantification (LLOQ) for urine was 0.0174 nmol/L expressed as free base. The amounts of unchanged formoterol excreted in urine from 0 to 3 hours (Ae0-3) and from 0 to 12 hours post-dose (Ae0-12) were calculated from the formoterol concentrations in urine and the urine volumes using non-compartmental methods.|0 to 3 hrs and 0-12 hrs|The pharmacokinetic population which was modified by the exclusion of dosing periods where formoterol was present at a concentration in excess of 5% of the Cmax.Five subjects were excluded due to various reasons.|||nmol||90% Confidence Interval|Least Squares Mean
1464425|NCT00746330|Secondary|Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS/ERS standards|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1464426|NCT00746330|Secondary|Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FVC is the volume (liters) of air that can forcibly be blown out after full inspiration. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS / ERS standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1464427|NCT00746330|Secondary|Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect|All efficacy evaluations were based on spirometry assessments of lung function. FEV1 is the maximum amount of air expired in one second. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the (ATS / ERS) standards.|5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1464428|NCT00746330|Primary|The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment|For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose|From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment).|Full Analysis Set|||liters||95% Confidence Interval|Least Squares Mean
1464429|NCT00746252|Primary|Weight Gain|Weight gain from baseline to last observation up to 12 weeks. Last observation carried to 12 weeks.|These measurements are done biweekly from baseline up until 12 weeks||||pounds||Standard Deviation|Mean
1464430|NCT00746239|Secondary|Evaluate the Association of Improving Sleep Quality (With Ramelteon) on Improvement in Severity of Panic Disorder/Anxiety.||10 weeks|||||||
1464431|NCT00746239|Primary|Evaluate the Effects of Ramelteon on Sleep Quality in Panic Disorder Patients Who Are Also Treated With Escitalopram.||10 weeks|||||||
1464432|NCT00746187|Primary|Marginal Bone Level Changes|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.|3 years after implant placement (baseline)|Per protocol analysis presented and this includes 86 implants in 36 patients. At 3-year follow-up, 74 implants in 31 patients were still in the study and thus evaluable for the analysis.|||millimeter|Participants|Standard Deviation|Mean
1464433|NCT00746096|Secondary|Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)|VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.|16weeks||||units on a scale||Standard Deviation|Mean
1464434|NCT00746096|Primary|Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)|"The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work~Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days"|16weeks|"Five patients in the IKH-01 group were excluded from efficacy analysis due to no available data for 3 patients and 2-4 administration days for 2 patients.~One patient in the placebo group was also excluded from efficacy analysis."|||units on a scale||Standard Deviation|Mean
1464435|NCT00746018|Primary|To Determine if the LigaSure Device, Which we Routinely Used for Removal of Tubes and Ovaries, is Effective at Destroying All Tubal Cells Comprising the Fallopian Tube Including Those Cells Within the Cornua of the Uterus.||conclusion of the study|Data were not collected||||||
1464436|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Acceptance Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1464437|NCT00745940|Secondary|Philadelphia Mindfulness Scale (Awareness Subscale)|The Philadelphia Mindfulness Scale (PHLMS) is a measure of mindfulness to assess present-moment awareness and acceptance. The questionnaire comprises 20 questions rated on a five-point Likert scale with higher scores indicative of greater mindfulness. It comprises two subscales - Awareness and Acceptance. The range of scores on the Awareness subscale is 10 to 50 and the range on the Acceptance subscale is 10 to 50 with higher scores indicative a greater awareness and acceptance respectively.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1464438|NCT00745940|Secondary|Symptom Checklist-90 Revised (Depression Subscale)|The Symptom Checklist-90 Revised (SCL-90-R) is a 90 item self-report questionnaire designed to measure nine primary symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism from the last two weeks from the current point in time. A five point Likert scale is used ranging from “Not at All” to “Extremely” with higher scores indicative of greater symptoms. There are 13 questions in the depression subscale with scores ranging between 0 and 52. To help with interpretation of all SCL-90-R sub-scales, we transformed this sub-scale total score back to a score between 0 to 4 with higher scores indicating greater depression symptoms.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1464439|NCT00745940|Primary|Beck Depression Inventory - II|The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. It assesses the intensity of depression into 4 categories ranging from minimal (scores from 0-13) to severe (scores from 29-63) (79). Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The depression criteria are consistent with those of the Diagnostic and Statistical Manual of Mental Health Disorders—Fourth Edition (DSM-IV). The cognitive-affective factor includes items concerning sadness, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, worthlessness, and irritability. The somatic factor is comprised of loss of energy, changes in sleeping pattern, changes in appetite, concentration difficulty, and tiredness or fatigue.|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1464440|NCT00745940|Secondary|Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a self-administered questionnaire based on the PRIME-MD diagnostic instrument for common mental disorders. Each of the 9 DSM-IV criteria is scored on a four point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with higher scores indicative of greater depression symptoms. Scores range from a low of 0 to a high of 27."|Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.||||units on a scale||Standard Deviation|Mean
1464441|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Participants|||Number
1464442|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 2|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Participants|||Number
1464443|NCT00745901|Primary|Number of Participants With Breakthrough Bleeding/Spotting Cycle 1|Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1464444|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 3|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Participants|||Number
1464445|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 2|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Participants|||Number
1464446|NCT00745901|Primary|Number of Participants With Unscheduled Bleeding Cycle 1|Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1464447|NCT00745901|Primary|Overall Number of Days of Total Blood Loss|cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 to 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1464495|NCT00745368|Primary|Female Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1464496|NCT00745368|Primary|Male Paired Plasma Concentration|This sample was taken as close to the time of genital tract sample as possible|8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1464448|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 3 (Day 57 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
1464449|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 2 (day 29 to Day 56)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
1464450|NCT00745901|Primary|Number of Days of Total Blood Loss – Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity.|Cycle 1 (Day 8 to Day 28)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1464451|NCT00745901|Primary|Overall Number of Days of Scheduled Blood Loss|summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 to Cycle 3 (Day 8 to Day 84)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1464452|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 3|cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
1464453|NCT00745901|Primary|Number of Days of Scheduled Blood Loss – Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
1464454|NCT00745901|Primary|Number of Days of Scheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen.|Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1464455|NCT00745901|Primary|Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes|Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1464456|NCT00745901|Primary|Overall Number of Days of Unscheduled Blood Loss|cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 to Cycle 3 (Day 8 to Day 80)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1464457|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 3|Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3.|||Days||Standard Deviation|Mean
1464458|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 2|cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2.|||Days||Standard Deviation|Mean
1464459|NCT00745901|Secondary|Patient Satisfaction - Overall|patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied.|Cycle 1 to Cycle 3|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Participants|||Number
1464497|NCT00745368|Primary|Raltegravir Female Genital Tract Concentration||8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1464498|NCT00745368|Primary|Raltegravir Male Genital Tract Concentration||8-10 hours after raltegravir dose||||ng/mL||Inter-Quartile Range|Median
1464460|NCT00745901|Primary|Number of Days of Unscheduled Blood Loss - Cycle 1|cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1–4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1–7 of the first cycle.|Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)|Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7.|||Days||Standard Deviation|Mean
1464461|NCT00745875|Secondary|Progression-free Survival|Median time (in days) from randomisation until disease progression/death using the Kaplan-Meier method|Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuation||||Days||Full Range|Median
1464462|NCT00745875|Primary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)|Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).||||Days||Full Range|Median
1464463|NCT00745823|Secondary|Number of Participants Who Discontinued Due to an Adverse Event at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|||||||
1464464|NCT00745823|Secondary|Number of Participants With One or More Adverse Events at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|||||||
1464465|NCT00745823|Secondary|Mean Change From Baseline to Week 96 in CD4 Cell Count|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Baseline and Week 96|The Week 96 data analysis was not performed.||||||
1464466|NCT00745823|Secondary|Number of Participants With HIV RNA <400 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.||||||
1464467|NCT00745823|Secondary|Number of Participants With HIV RNA <50 Copies/mL at 96 Weeks|As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.|Week 96|The Week 96 data analysis was not performed.||||||
1464468|NCT00745823|Secondary|Mean Change From Baseline to Week 48 in CD4 Cell Count||Baseline and Week 48|Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy.|||cells/mm^3||95% Confidence Interval|Mean
1464469|NCT00745823|Primary|Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.|||Participants|||Number
1464470|NCT00745823|Primary|Number of Participants With One or More Adverse Events at 48 Weeks||Week 48|Data were analyzed for all randomized participants who received at least one dose of study drug.|||Participants|||Number
1464471|NCT00745823|Secondary|Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks||48 weeks|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.|||Participants|||Number
1464472|NCT00745823|Primary|Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks||Week 48|Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.|||Participants|||Number
1464473|NCT00745498|Secondary|Postoperative Resolution of Neovascularization||6 months|||||||
1464474|NCT00745498|Secondary|Visual Outcome|Best-corrected visual acuity (BCVA) at postoperative 6 months|6 months||||logMAR||Standard Deviation|Mean
1464475|NCT00745498|Secondary|Initial Time of Vitreous Clearing (ITVC)|The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels.|6 months||||days||Standard Deviation|Mean
1464476|NCT00745498|Primary|Recurrent VH Incidence (Early and Late)|"Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. Early recurrent VH was VH occurring <= 4 weeks and late recurrent VH was VH occurring >4 weeks after surgery."|6 months|With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis.|||Percentage of participants|||Number
1464477|NCT00745420|Secondary|Change From Baseline to 1 Year in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to 1 year post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|1 year post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1464478|NCT00745420|Secondary|Change From Baseline to 1 Year in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to 1 year post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|1 year post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1464499|NCT00745290|Secondary|Number of Participants With Adverse Events Through 96 Hours and Serious Adverse Events Through 30 Days||through 30 days|||||||
1465098|NCT00739661|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death by any cause.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.|||Months||Standard Deviation|Mean
1464479|NCT00745420|Secondary|Change From Baseline to Day 180 in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 180 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|180 days post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1464480|NCT00745420|Secondary|Change From Baseline to Day 180 in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 180 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|180 days post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1464481|NCT00745420|Secondary|Change From Baseline to Day 100 in Parent Proxy Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in parent proxy reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 100 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|100 days post-transplant|Parent proxies of participants that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1464482|NCT00745420|Secondary|Change From Baseline to Day 100 in Participant Reported Health-Related Quality of Life (HRQL)|HRQL will be assessed using the Self-Esteem, General Health Perception, and Change in Health subscales of the Child Health Questionnaire (CHQ Child Form 87). The changes in participant reported scores on these HRQL subscales from a pre-transplant baseline assessment to day 100 post-transplant will be evaluated. Each subscale is scored is scored in the range 0-100, with higher scores indicating better health and well-being. Therefore, a negative mean change in score denotes worsening HRQL score and positive mean change in score denotes an improved HRQL score over time.|100 days post-transplant|Participants age 10 years or older that returned the HRQL surveys|||units on a scale||Standard Error|Mean
1464483|NCT00745420|Secondary|Percentage of Participants With Posterior Reversible Encephalopathy Syndrome (PRES)||1 year||||percentage of participants||95% Confidence Interval|Number
1464484|NCT00745420|Secondary|Number of Participants With Chronic GVHD by Severity|Chronic GVHD severity is defined per NIH 2005 Consensus Criteria.|1 year post-transplant||||Participants|||Count of Participants
1464485|NCT00745420|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is defined per NIH 2005 Consensus Criteria.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
1464486|NCT00745420|Secondary|Percentage of Participants With Acute Graft-vs-Host-Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|100 days||||percentage of participants||95% Confidence Interval|Number
1464487|NCT00745420|Secondary|Graft Rejection|Primary graft rejection is defined as the presence of less than 20% donor cells as assessed by peripheral blood or bone marrow chimerism assays on or after Day 42. Secondary graft rejection is defined as the presence of less than 20% donor derived hematopoietic cells in peripheral blood or bone marrow that occurs after prior evidence of 20% or greater donor cells.|1 year||||Participants|||Count of Participants
1464488|NCT00745420|Secondary|Neutrophil and Platelet Recovery|Time to neutrophil recovery is defined as the time of the first of three measurements on consecutive days where the patient has an absolute neutrophil count of >= 500/uL following conditioning regimen induced nadir. Time to platelet recovery is defined as the time of the first of three measurements on consecutive days where the patient has achieved a platelet count > 50,000/uL and is platelet transfusion independent for a minimum of seven days following conditioning regimen induced nadir.|Up to 100 days||||days||Full Range|Median
1464489|NCT00745420|Secondary|Percentage of Participants With Overall Survival (OS)|OS is defined as the percentage of participants that have not died.|2 years||||percentage of participants||95% Confidence Interval|Number
1464490|NCT00745420|Primary|Percentage of Participants With Event-Free Survival (EFS)|EFS is defined as percentage of participants that have not had an event. Primary or secondary graft rejection, disease recurrence, or death will count as events for this endpoint.|2 years||||percentage of participants||95% Confidence Interval|Number
1464491|NCT00745368|Primary|Female Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose||||ratio||Inter-Quartile Range|Median
1464492|NCT00745368|Primary|Male Genital Tract:Plasma Concentration Ratio|Units of raltegravir concentration for genital tract and plasma sample are ng/mL|8-10 hours after raltegravir dose||||ratio||Inter-Quartile Range|Median
1464493|NCT00745368|Primary|Female Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose||||hours||Inter-Quartile Range|Median
1464494|NCT00745368|Primary|Male Time Since Last Dose|This measure describes the amount of time that expired between when the dose was administered and when the sample was taken|8-10 hours after raltegravir dose||||hours||Inter-Quartile Range|Median
1464500|NCT00745290|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores|The subject’s pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, “On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?”|through 72 hours post surgery|Note: 245 subjects were randomized and received study drug and were included in the analyses.|||Units on a scale*hours||Standard Deviation|Mean
1464501|NCT00745251|Secondary|Percent Change in Weight From Baseline to Week 28||baseline to week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||percent change||Standard Error|Least Squares Mean
1464502|NCT00745251|Primary|Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.|AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep|between baseline and Week 28|Intent-to-treat Last-observation-carried-forward (ITT-LOCF)|||events/hour||Standard Error|Least Squares Mean
1464503|NCT00745095|Secondary|Polyp Detection|The number of polyps detected during colonoscopic procedures were recorded and compared to each bowel cleansing preparation.|Time of Study||||Number of polyps detected (numerical)||Standard Deviation|Mean
1464504|NCT00745095|Primary|Quality of Bowel Preparation|The quality of bowel preparation was determined by using the Ottawa Scale for bowel Evacuation. The range of this score is from 0 (perfectly clean and dry colon) to 14 ( a colon filled with stool and liquid). The right, mid and rectosigmoid colon were independently rated from 0-4 and fluid quality of entire colon was recorded with an additional score of 0-2. The total Ottawa Score is calculated by the sum of the independent scores of all three sections of the colon plus the fluid content.|1-2 days following intervention||||units on a scale||Standard Deviation|Mean
1464505|NCT00745030|Secondary|Study Terminated Due to Low Subject Recruitment and Enrollment.|Low subject recruitment and enrollment||||||||
1464506|NCT00745030|Secondary|Changes in The Montreal Cognitive Assessment Scale (MoCA)||12 weeks|||||||
1464507|NCT00745030|Secondary|Changes in Mini-Mental State Exam (MMSE)||12 weeks|||||||
1464508|NCT00745030|Secondary|Changes in Physician Completed United Parkinson’s Disease Rating Scale (UPDRS)||12 weeks|||||||
1464509|NCT00745030|Secondary|Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale)||12 weeks|||||||
1464510|NCT00745030|Secondary|Changes in Patient Completed The Fatigue Severity Scale (FSS)||12 weeks|||||||
1464511|NCT00745030|Secondary|Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed)||12 weeks|||||||
1464512|NCT00745030|Secondary|Changes in Beck Depression Inventory (BDI)||12 weeks|||||||
1464513|NCT00745030|Secondary|Changes in Patient Completed Epworth Sleepiness Scale (ESS)||12 weeks|||||||
1464514|NCT00745030|Secondary|Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale||12 weeks|||||||
1464515|NCT00745030|Secondary|Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner)||12 weeks|||||||
1464516|NCT00745030|Secondary|Changes in Clinician Global Impression Scale of Improvement (CGI-I)||10 weeks|||||||
1464517|NCT00745030|Secondary|Changes in Mean TST, LPS, WASO (Based on PSG)||8 weeks|||||||
1464518|NCT00745030|Secondary|Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study||8 weeks|||||||
1464519|NCT00745030|Primary|Change in the Frequency of RBD Based on the Daily Sleep Diaries, Completed Daily for the Duration of the Study by the Study Subjects' Bed Partners/Caregivers|"Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers.~Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment."|12 weeks||||Participants|||Number
1464520|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 6|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Identification at Week 6.|||log10 millisecond||Standard Error|Least Squares Mean
1464521|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 3|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Identification at Week 3.|||log10 millisecond||Standard Error|Least Squares Mean
1464522|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Identification at Week 1|Assessment of the cognitive domain visual attention through a yes or no response to 30 trials within 5 minutes; score range: 0 to 3.69. Performance variable: speed of performance; average log10 transformed reaction time for correct responses. Reaction times longer than 5 seconds ( log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Identification at Week 1.|||log10 millisecond||Standard Error|Least Squares Mean
1464523|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 6|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for Visual Learning at Week 6.|||arcsine proportion correct||Standard Error|Least Squares Mean
1464576|NCT00744692|Secondary|To Evaluate the Incidence of Late Graft Failures at 2 Years Post-transplant||2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late graft failure endpoint.|||participants|||Number
1464524|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 3|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for Visual Learning at Week 3.|||arcsine proportion correct||Standard Error|Least Squares Mean
1464525|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Visual Learning at Week 1|Assessment of the cognitive domain episodic memory through yes or no responses within 5 minutes to 4 targets repeated among 6 distractors on 4 rounds (mild Alzheimer's disease [AD], or 3 targets repeated among 4 distractors on 4 rounds (moderate AD) ; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for Visual Learning at Week 1.|||arcsine proportion correct||Standard Error|Least Squares Mean
1464526|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 6|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 6|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 6.|||arcsine proportion correct||Standard Error|Least Squares Mean
1464527|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 3|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 3|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 3.|||arcsine proportion correct||Standard Error|Least Squares Mean
1464528|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: One Back Working Memory at Week 1|Assessment of the cognitive domain working memory through yes or no responses to 30 trials within 5 minutes; score range: 0 to 1.57. Performance variable: accuracy of performance; arcsine transformation of proportion correct responses.|Week 1|FAS; N = number of participants with a CogState score for One Back Working Memory at Week 1.|||arcsine proportion correct||Standard Error|Least Squares Mean
1464529|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 6|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 6|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 6.|||errors||Standard Error|Least Squares Mean
1464530|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 3|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 3|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 3.|||errors||Standard Error|Least Squares Mean
1464531|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Continuous Paired Associate Learning (CPAL) at Week 1|Assessment of the cognitive domain visual episodic memory (associate learning) through responses within 7 minutes to 4 targets x 4 rounds (mild AD) or 3 targets x 4 rounds (moderate AD); score range: 35 to 100. Performance variable: number of errors made in correctly placing each of the 4 patterns in their location four times.|Week 1|FAS; N = number of participants with a CogState score for Continuous Paired Associate Learning at Week 1.|||errors||Standard Error|Least Squares Mean
1464532|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 6|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 6|FAS; N = number of participants with a CogState score for Detection at Week 6.|||log10 millisecond||Standard Error|Least Squares Mean
1464533|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 3|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 3|FAS; N = number of participants with a CogState score for Detection at Week 3.|||log10 millisecond||Standard Error|Least Squares Mean
1464534|NCT00744978|Secondary|Computerized Test Battery for Cognition (CogState) Tasks: Detection at Week 1|Assessment of the cognitive domain psychomotor function through yes or no responses within 5 minutes to 30 trials; score range: 0 to 3.69. Performance variable: speed of performance; average of the log10 t transformed reaction time for correct responses. Reaction times longer than 5 seconds (log10 [5000]) were excluded as reflecting responses that were abnormally slow.|Week 1|FAS; N = number of participants with a CogState score for Detection at Week 1.|||log10 millisecond||Standard Error|Least Squares Mean
1464535|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 6|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 6|FAS. N = number of participants with a NPI total score at Week 6.|||scores on scale||Standard Error|Least Squares Mean
1465826|NCT00734539|Secondary|Candidiasis|Definite or probable|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1464536|NCT00744978|Secondary|Neuropsychiatric Inventory (NPI) Total Score at Week 3|Caregiver interview-based rating scale assessing 12 behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, appetite/eating, and sleep. Each symptom score derived by frequency of symptoms * severity of symptoms (range 0-12). Total score = sum of symptom scores; range: 0-144 with higher score indicating greater behavioral disturbances.|Week 3|FAS. N = number of participants with a NPI total score at Week 3.|||scores on scale||Standard Error|Least Squares Mean
1464537|NCT00744978|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 6|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 6|FAS; N = number of participants with a CGI-I score at Week 6.|||units on a scale||Standard Error|Least Squares Mean
1464538|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 6|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 6|FAS. N = number of participants with ADAS-Cog 70 results at Week 6.|||units on scale||Standard Error|Least Squares Mean
1464539|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3|11-item scale designed to assess the severity of cognitive impairments in AD subjects. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, and remembering test instructions. Total score range from 0-70 with 70 indicating worse cognition.|Week 3|FAS. N = number of participants with ADAS-Cog 70 results at Week 3.|||units on scale||Standard Error|Least Squares Mean
1464540|NCT00744978|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 3|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 3|FAS; N = number of participants with ADAS-Cog 75 results at Week 3.|||units on scale||Standard Error|Least Squares Mean
1464541|NCT00744978|Primary|Alzheimer's Disease Assessment Scale-Cognitive Subscale 75 (ADAS-Cog 75) at Week 6|12-item scale to assess severity of cognitive impairment in AD. Items include word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, spoken language ability, comprehension of spoken language, word finding difficulty in spontaneous speech, remembering test instructions, and concentration/distractibility. Total score range from 0-75 with 75 indicating worse cognition.|Week 6|Full analysis set (FAS): all participants who were randomized and took at least 1 dose of randomized study medication. N = number of participants with ADAS-Cog 75 results at Week 6.|||units on scale||Standard Error|Least Squares Mean
1464542|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1464543|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1464544|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
1464545|NCT00744939|Secondary|Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set|Adverse events occurring within 1 day after administration of Magnevist or skin-related adverse events occurring during follow-up (FU) were recorded.|Up to 24 months following the administration of Magnevist|Full analysis set.|||Participants|||Number
1464546|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle ore epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1465827|NCT00734539|Secondary|Neurodevelopmental Impairment|Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy|18-22 months corrected gestational age|Attended the follow-up visit and had complete data on composite endpoint|||participants|||Number
1464547|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Per protocol set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1464548|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
1464549|NCT00744939|Secondary|Total Number of Participants With Clinicopathological Correlation of ‘NSF’ or ‘Consistent With NSF’ and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score need at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 required more than 1 minor criterion, 1 major criterion or more than 1 major criterion respectively. Major criteria: patterned plaques, joint contractures, cobblestoning, marked induration/Peau d’orange (upper extremity or above knee); minor Criteria: puckering/linear banding, superficial (plaque/patch), dermal papules, scleral plaques (subject aged <45 yrs). Pathology score 2, 3 or 4 required 2, 3 or at least 4 histological criteria respectively. Histological criteria include Increased cellularity with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and Septal involvement. A clinical score of 4 was suggestive of developing clinical signs consistent with NSF in subjects without biopsy."|Up to 24 months following the administration of Magnevist|Full analysis set|||Participants|||Number
1464550|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1464551|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Per Protocol Set. Participants with mild and extended moderate renal impairment were excluded from the per protocol analysis.|||Participants|||Number
1464564|NCT00744848|Primary|Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores|To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, “On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?”|through 96 hours|Note: 204 randomized subjects received study drug and were included in the analyses.|||Units on a scale*hours||Standard Deviation|Mean
1465588|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Eosinophils|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 10%.|78 weeks|Treated Set with values for Eosinophils|||participants|||Number
1464552|NCT00744939|Primary|Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set|||Participants|||Number
1464553|NCT00744939|Primary|Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set|"Either clinical or histopathology score had to be at least 2 and the other at least 3 for diagnosis of NSF. Clinical score 2, 3 or 4 was derived from more than one minor criterion finding, one major criterion finding or more than one major criterion finding respectively. Major Criteria include patterned plaques, joint contractures, cobblestoning and marked induration/Peau d’orange (upper extremity or above knee); minor Criteria include puckering/linear banding, superficial (plaque/patch), dermal papules and scleral plaques (subject aged <45 years). Pathology score 2, 3 or 4 was derived from 2, 3 or at least 4 histological criteria findings respectively. Histological Criteria include increased cellularity (spindled and/or epithelioid) with few other inflammatory cells, CD34+ spindle or epithelioid cells in a reticular or parallel arrangement with “tram-tracking, presence of both fine collagen and ropey collagen surrounded by clefts, elastic fibers preserved and septal involvement."|Up to 24 months following the administration of Magnevist|Full Analysis Set|||Participants|||Number
1464554|NCT00744874|Secondary|Total Fluoroscopy Time|Total time that flouroscopy was used during the ablation procedure.|Post Ablation Procedure||||minutes||Standard Deviation|Mean
1464555|NCT00744874|Secondary|Total Procedure Time|Measurement of total procedure time defined as “skin to skin” and left atrial dwell time (transseptal puncture to removal of all left atrial catheters)|End of Procedure||||minutes||Standard Deviation|Mean
1464556|NCT00744874|Secondary|Measurement of the Cumulative RF Time for Pulmonary Vein(PV)Isolation of All Accessible Pulmonary Veins|Cumulative RF time was calculated by the difference between the start time of catheter ablations and the end time of the ablation|After Procedure||||minutes||Standard Deviation|Mean
1464557|NCT00744874|Secondary|The Short Form 36 Question (SF-36) Health Survey Quality of Life Survey at 6 Months Compared to Baseline|The SF-36 is a short-form health survey of 36 questions that yields an 8-scale health profile as well as psychometrically-based physical and mental health summary measures. In order to assess improvement in self-perceived quality of life, subjects were asked to complete SF-36 questionnaires at baseline and at each follow-up visit. The results of the Physical Component and Mental Component scores from the two summary measures that aggregate sub-scales were then compared.The SF-36 subscales range from 0 (lowest) to 100 (highest). The subscales are averaged together for a total score between 0 to 100. A higher score represents a better outcome when compared to a lower score.|6 months||||units on a scale||Standard Deviation|Mean
1464558|NCT00744874|Secondary|Atrial Fibrillation Symptom Severity Scores From Baseline to 6 Months|Subjects rated the severity of their AF-related symptoms at baseline and at each follow-up visit for the study. Symptoms that were assessed at each visit included the presence of palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and/or lack of energy upon exertion or exercise. Each symptom was rated on a scale from 1 (no symptoms) to 5 (most severe). Total scores were obtained by adding up the rating for each symptom to obtain a range of results between 5 (asymptomatic) to 25 (severely symptomatic).|6 Months||||units on a scale||Standard Deviation|Mean
1464559|NCT00744874|Primary|Chronic Safety|The Chronic Safety Endpoint was the proportion of subjects with serious procedure- and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|7 day post procedure to 6 months|The Chronic Safety Endpoint is the proportion of subjects with serious procedure and/or device-related events in the 7 day to 6 month follow-up period post-ablation. The relatedness of each event was assessed by the investigator at each site.|||participants|||Number
1464560|NCT00744874|Primary|Acute Safety|The Acute Safety Endpoint was defined as the proportion of subjects with Serious Adverse Events (SAEs) that were procedure- and/or device-related within 7 days after the ablation procedure. The relatedness of each event was assessed by the investigator at each site.|7 days post procedure|The proportion of subjects with one or more serious procedure and/or device related AEs occurring within 7 days of the ablation procedure. No acute events were related to the device.|||participants|||Number
1464561|NCT00744874|Primary|Chronic Effectiveness|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit. In order to be classified as a chronic success, all subjects were required to meet the following criteria: Absence of clinically significant AF (greater than 60 seconds) or left atrial tachycardia recorded on a 7-day Holter, absence of symptomatic AF after a 3 month blanking period, off all Class I and III AADs at 6 months.|6 months|The primary endpoint for chronic effectiveness was the evaluation of the proportion of subjects with treatment success computed at the 6 month visit.|||participants|||Number
1464562|NCT00744874|Primary|Number of Participants With Successful Pulmonary Vein Isolation|Acute effectiveness was defined as successful isolation of all pulmonary veins. Pulmonary vein isolation was documented by the absence of pulmonary vein potentials when assessed by electrogram tracings in sinus rhythm using the PVAC catheter.|6 months|Subjects that had successful pulmonary vein isolation.|||participants|||Number
1464563|NCT00744848|Secondary|Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30||through day 30|||||||
1465589|NCT00736099|Primary|Number of Patients With Abnormalities in Vital Signs|Vital sign abnormalities (any abnormalities found during PE or ECG are reported with adverse events)|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1464565|NCT00744757|Secondary|Quality of Life Assessment|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1=Not at All' to 4=Very Much') and 2 questions: Q29 on overall health and Q30 on overall quality of life uses 7-point scale ranging from 1=Very Poor to 7=Excellent. Higher score indicates better quality of life.|Day 1 of Cycle 1 and Cycle 8 (each cycle of 28 days)|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Unit on a scale||Standard Deviation|Mean
1464566|NCT00744757|Secondary|Number of Events Which Led to Hospitalization|The events (reasons) for hospitalizations such as infection, transfusion, acute choleycystitis, allergic transfusion reaction, dyspnoea with right pleural effusion, febrile neutropenia, fever, for decitabine, Myelodysplastic Syndrome (MDS) hematuria, paronychia, pneumonia, heart failure, peri-anal abscess (PAA), pancytopenia,fluctuated neutropenia fever, right dorsal foot cellulitis, Right lower (Rt.Lw) lung pneumonia with impending respiratory (resp) failure, Serious adverse event (SAE)+schedule hospitalization for decitabine, septic shock and not available were reported.|Start of treatment until disease progression or death or up to Cycle 8, each cycle of 28 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Events|||Number
1464567|NCT00744757|Secondary|Duration for Hospitalization|Duration of hospitalization was calculated for each participant, using the sum of all hospital days by subtracting the date of discharge from the date of admission.|Cycle 1 up to Cycle 8, each cycle of 28 days.|ITT population was defined as all participants who had received at least one dose of treatment. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Days||Standard Deviation|Mean
1464568|NCT00744757|Secondary|Percentage of Participants With Transfusion Independency|Transfusion independent participants were calculated from all the participants who required transfusion in the duration of 8 weeks before first dose until disease progression or death or up to 736 days. Transfusion independence was defined as lack of requirement for transfusions for at least 8 weeks.|8 weeks before first dose and 736 days of treatment|ITT population was defined as all participants who had received at least 1 dose of study medication.|||percentage of participants|||Number
1464569|NCT00744757|Secondary|Percentage of Participants With Transfusion Dependency|Transfusion requirements for both red blood cells as well as platelets were recorded for each participant.|8 weeks before first dose until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Percentage of participants|||Number
1464570|NCT00744757|Secondary|Overall Survival|Overall survival was defined as the time from the date of treatment start until death (whatever the cause). It was calculated from Kaplan-Meier estimates. Participants still alive were censored at the moment of last visit or contact.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Months||Full Range|Median
1464571|NCT00744757|Secondary|Time to Acute Myeloid Leukemia (AML) Progression or Death|Time to AML is defined as greater than 30 percent of blasts in bone marrow or the time to death was calculated from the date of treatment start until disease progression to AML or until death, which ever occurred first. Participants who were still alive and did not progress to AML were censored at the moment of last visit.|Start of treatment until disease progression or death (whichever occur first) or up to 736 days|ITT population was defined as all participants who had received at least 1 dose of study medication.|||Months||Full Range|Median
1464572|NCT00744757|Secondary|Percentage of Participants With Cytogenetic Response|Cytogenetic responses was assessed as per IWG 2006 criteria which define complete response as disappearance of the chromosomal abnormality without appearance of new ones and partial response as at least 50 percent reduction of the chromosomal abnormality.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|ITT population was defined as all participants who had received at least one dose of treatment. Here 'N' specifies those participants who were evaluated for this outcome measure and ‘n’ specifies those participants who were evaluated at given time point.|||Percentage of participants|||Number
1464573|NCT00744757|Secondary|Percentage of Participants With Hematologic Treatment Response|Hematologic treatment response was assessed as per IWG 2006 criteria. This is measured in erythroid(HI-E), platelet(HI-P) and neutrophil(HI-N) lineages. HI-E response(pre-treatment<11 gram per deciliter [g/dl]):hemoglobin increase by>=1.5 g/dl and relevant reduction in RBC transfusions by 4 RBC transfusions/8week. HI-P response (pre-treatment<100*109/l):absolute increase of >=30*10^9/l for participants starting with>20*10^9/l and increase from <20*10^9/l to>20*10^9/l and by at least 100%. HI-N response (pre-treatment<1.0*10^9/l): at least 100% increase and an absolute increase >0.5*10^9/l.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7 and 8, each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|Intent-to-treat (ITT) population was defined as all participants who had received at least one dose of treatment. Here ‘N’ specifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluable for this outcome measure at given time point.|||Percentage of participants|||Number
1464574|NCT00744757|Primary|Percentage of Participants With Response|Percentage of participants with response: complete response (CR) or partial response (PR) according to International Working Group (IWG) 2006 criteria was evaluated. CR in bone marrow is defined as<=to 5% myeloblasts with normal maturation of all cell lines and persistent dysplasia was noted in peripheral blood hemoglobin >=11 gram (g) per deciliter (dl), platelets >=100*10^9 liter (l), neutrophils >=1.0*10^9 l, Blasts 0%. Partial response is defined as all CR criteria if abnormal before treatment except: bone marrow blasts decreased by >=50% over pre-treatment but still >=5%.|Day 1 of Cycle 2, 4, 6, 8; each Cycle of 28 days and End of treatment (30-42 days after Cycle 8 or early withdrawal)|The efficacy-evaluable (EE) population included all participants who received at least 2 cycles of treatment. Participants who died before receiving 2 complete cycles or were taken off study due to progressive disease were included. Here ‘N’ specifies those participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1464575|NCT00744692|Secondary|To Describe the Pace of Platelet Recovery|Platelet engraftment was defined as the first day of platelet counts more than 50,000/uL for 7 consecutive days without transfusions|180 days post transplant||||days||Full Range|Median
1464577|NCT00744692|Secondary|To Evaluate Long-term Complications, Such as Sterility, Endocrinopathy, and Growth Failure||at least 2 years post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of this 2 year late effects endpoint.|||percentage of patients|||Number
1464578|NCT00744692|Secondary|To Describe the Incidence of Grade 3-4 Organ Toxicity||2 years post transplant||||participants|||Number
1464579|NCT00744692|Secondary|To Describe Incidence of Acute Graft Versus Host Disease (GVHD) (II - IV)|To describe incidence of acute Graft Versus Host Disease (GVHD) (II - IV) : measured by cumulative incidence analysis|100 days post transplant||||percentage of participants||95% Confidence Interval|Number
1464580|NCT00744692|Secondary|To Determine the Overall Survival at day180 Post-transplant|To determine the overall survival at day180 post-transplant: determined by Kaplan Meier survival analysis|180 days||||percentage of participants||95% Confidence Interval|Number
1464581|NCT00744692|Secondary|To Evaluate the Pace of Immune Reconstitution.|Immune reconstitution after RIC in UCBT was described. CD4 count is a standard measure of immune reconstitution and is described here. Additional data is available upon request.|1 year post transplant|Of the 22 patients at baseline, 5 patients died early before a year; and 2 additional patients had early graft failure. Thus 7 patients were not available for analysis of Immune reconstitution endpoint. CD4 count is reported here.|||cells/uL||Full Range|Median
1464582|NCT00744692|Secondary|To Describe the Pace of Neutrophil Recovery|Neutrophil recovery was defined as the first day of an absolute neutrophil count (ANC) more than 500/uL for 3 consecutive days not secondary to granulocyte infusions|42 days post transplant||||days||Full Range|Median
1464583|NCT00744692|Primary|Determine the Feasibility of Attaining Acceptable Rates of Donor Cell Engraftment (>25% Donor Cells at 180 Days) Following RIC Regimens in Children < 21 Years Receiving UCBT for Non-malignant Disorders.|Determine the feasibility of attaining acceptable rates of donor cell engraftment (>25% donor cells at 180 days) following reduced intensity conditioning regimens in children < 21 years receiving cord blood transplant for non-malignant disorders.|180 days post transplant|Of the 22 patients enrolled, 18 patients were alive at 180 days, the time-point for primary end point|||% of participants|||Number
1464584|NCT00744653|Secondary|Safety and Toxicity||up to 1 year|per protocol|||adverse events|Participants||Number
1464585|NCT00744653|Secondary|Participants With Objective Response Evaluated With PET/CT|Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.|3, weeks, 8 weeks, and up to 6 months after treatment|per protocol|||participants|||Number
1464586|NCT00744653|Primary|Clinical Measure of Lesion Size.|Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size|up to one year|Based on Simons optimal design for phase II trials, 25 evaluable patients were to be included and treated.|||Participants|||Number
1464587|NCT00744627|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set.|||participants|||Number
1464588|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464589|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464590|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464591|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1507942|NCT00413634|Primary|Volume of Distribution (Vz/F) of Agrylin||over 1 day|PK population|||L||Standard Deviation|Geometric Mean
1464592|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464593|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464594|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464595|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464596|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464597|NCT00744627|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression-Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464598|NCT00744627|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1464599|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1507943|NCT00413634|Primary|Total Clearance (CL/F) of Agrylin||over 1 day|PK population|||L/h||Standard Deviation|Geometric Mean
1464600|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1464601|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2 and 4|"Full analysis set where Baseline data were available. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464602|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464603|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1 and 4|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464604|NCT00744627|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1464605|NCT00744627|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1464606|NCT00744627|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1464607|NCT00744627|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥ 50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.|||percentage of participants|||Number
1464620|NCT00744497|Other Pre-specified|Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable|||Participants|||Number
1464608|NCT00744627|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1464609|NCT00744627|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression-Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a MMRM with baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1464610|NCT00744627|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1464611|NCT00744627|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1464612|NCT00744523|Secondary|Access Site Adverse Events|Number of subjects with adverse events at the percutaneous access site as a result of the index procedure, including bruising, hematoma and bleeding requiring treatment by transfusion of blood products, surgical repair, ultrasound compression or thrombin injection.|Index Procedure through Hospital Discharge||||participants|||Number
1464613|NCT00744523|Secondary|Target Lesion Revascularization at 30 Days|Number of subjects with any repeat invasive procedure, including angioplasty, stenting, endarterectomy, or thrombolysis, performed to open or increase lumen diameter inside or within 10 mm of the previously treated lesion.|Up to 30 days after the procedure was performed||||participants|||Number
1464614|NCT00744523|Secondary|Restenosis at 30 Days|Number of subjects with re-narrowing of the lesion at 30 days as defined as a >= 50% stenosis measured by duplex ultrasound scan.|Up to 30 days after the procedure was performed||||participants|||Number
1464615|NCT00744523|Secondary|Procedural Success|"Number of subjects with technical success without the occurrence of any MACCE or unresolved antegrade flow blockage intolerance during the index hospitalization.~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure through hospital discharge||||participants|||Number
1464616|NCT00744523|Secondary|Technical Success|"Number of subjects with device success and the ability to successfully implant a carotid stent and obtain a residual stenosis < 30% during the index procedure(as evaluated by the angiographic core laboratory).~Note: Three subjects were missing final angiographic results and therefore Technical and Procedural success could not be defined for these three subjects, thereby, decreasing the number of participants analyzed from 225 to 222."|The entire duration of the index procedure|Roll-In participants were analysed on the number of roll-in cases performed. Pivotal subjects were analysed as Intention To Treat (ITT).|||participants|||Number
1464617|NCT00744523|Secondary|Device Success|Number of subjects in which the MO.MA was able to be positioned, deployed, and retrieved intact during the index procedure.|The entire duration of the index procedure|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria who were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.|||participants|||Number
1464618|NCT00744523|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE) Within 30 Days of the Procedure.|Number of subjects with one or more Major Adverse Cardiac and Cerebrovascular Events through 30 days after the procedure. MACCE are defined as: any myocardial infarction (MI), stroke, or death through day 30 post-procedure.|Up to 30 days after the procedure was performed|Roll In Population - All subjects enrolled prior to the pivotal phase at each US site. Pivotal - All subjects who fulfilled the eligibility criteria and were screened and enrolled to undergo carotid stenting with cerebral protection with the MO.MA device. ITT - All subjects enrolled regardless of subsequent treatment.|||participants|||Number
1464619|NCT00744497|Other Pre-specified|Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study|BL=baseline; OS=on-study|At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated|All participants who were randomized to receive any treatment|||Participants|||Number
1464638|NCT00744380|Secondary|Sedation-related Adverse Effects||Duration of ICU stay, up to 24 weeks||||participants|||Number
1464621|NCT00744497|Other Pre-specified|Number of Participants by Maximal On-study Fridericia-corrected QTc Interval|QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.|At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing|All participants who received treatment. n=number evaluable|||Participants|||Number
1464622|NCT00744497|Other Pre-specified|Number of Participants With Abnormal Results in Urinalysis|Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment.|||Participants|||Number
1464623|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes|ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0–10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0–6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment|||Participants|||Number
1464624|NCT00744497|Other Pre-specified|Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology|Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L.|At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.|All participants who received treatment|||Participants|||Number
1464625|NCT00744497|Other Pre-specified|Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. Drug-related=having certain, probable, possible, or missing relationship to study drug. Drug-related AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count.|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment|||Participants|||Number
1464626|NCT00744497|Other Pre-specified|Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug|Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days|All participants who received treatment|||Participants|||Number
1464627|NCT00744497|Secondary|Percentage of Participants With a Reduction in Pain Intensity From Baseline|The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.|At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants with a baseline pain intensity of 2 or greater|||Percentage of participants||95% Confidence Interval|Number
1464628|NCT00744497|Secondary|Time to Prostate Specific Antigen (PSA) Progression|PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.|From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1464639|NCT00744380|Secondary|The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)|The Riker sedation-agitation score (range 1-7) and PABS (range 0-10) are assessed hourly by the bedside nurse. Riker scores assess restlessness and cooperation. Riker scores of 5 – 7 indicate agitation, 3 - 4 represent adequate sedation and 1 - 2 represent excessive sedation. PABS assessments include domains of restlessness, muscle tone, vocalization, consolability, and facial expressions. PABS assessments of 0 represent no pain, 1 - 3 represent mild pain, 4 - 6 represent moderate pain, and ≥ 7 represent severe pain.|Duration of ICU stay, for up to 24 weeks||||percentage of assessments while on study|||Number
1464629|NCT00744497|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.|From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1464630|NCT00744497|Secondary|Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline|The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal.|At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)|Participants who entered the study with baseline urinary N-telopeptide values higher than the upper limit of normal (ULN), or ≥60 nmol/mmol creatinine, if ULN was missing|||Percentage of participants||95% Confidence Interval|Number
1464631|NCT00744497|Secondary|Time to First Skeletal-related Event (SRE)|Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.|From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1464632|NCT00744497|Secondary|Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.|At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)|Participants with at least 1 target lesion at baseline|||Percentage of participants||95% Confidence Interval|Number
1464633|NCT00744497|Primary|Overall Survival: Time From Randomization to Date of Death|Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.|From randomization to death or date of last contact (maximum reached: 45 months)|All participants who were randomized to receive any treatment|||Months||95% Confidence Interval|Median
1464634|NCT00744380|Secondary|Hospital Anxiety and Depression Scale (HADS) Score|The HADS consists of 14 questions, seven for anxiety and seven for depression. Each item is scored from 0 to 3, with a cut-off cumulative score of 11 for both subscales indicative of anxiety or depression. This scoring tool has been used for 30 years, possesses excellent reliability and validity, and avoids reliance conditions that are also common somatic symptoms of illness such fatigue, insomnia, and hypersomnia. The maximum score for each subscale is 21 with a maximum possible cumulative score of 42. The minimum score for each subscale is 0. The minimum cumulative score is 0|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the HADS were provided the assessment. Seven subjects were excluded.|||units on a scale||Standard Deviation|Mean
1464635|NCT00744380|Secondary|Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)|The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately often,” 3 = “quite a bit,” and 4 = “extremely often.” The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the IES-R were provided the assessment. Seven subjects were excluded.|||units on a scale||Standard Deviation|Mean
1464636|NCT00744380|Secondary|Duration of Study Drug Administration||Duration of ICU stay, up to 24 weeks||||days||Inter-Quartile Range|Median
1464637|NCT00744380|Secondary|ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)|The ICU-SEQ assesses patient recall of their ICU experience. The ICU-SEQ assesses both psychological (e.g. fearfulness, anxiety) and physical (e.g. pain, difficulty breathing) perceptions of ICU patients who have received mechanical ventilation. It consists of 29 potentially stressful experiences with seven items specifically addressing the endotracheal tube. The extent that patients are bothered by each item is scored on a five point scale: 0 = “not at all,” 1 = “a little bit,” 2 = “moderately,” 3 = “quite a bit,” and 4 = “extremely.” The cumulative score is an integer interpreted as interval data with higher scores indicating greater stressful experiences associated with the ICU. The minimum score is 0 and the maximum score possible is 116.|Duration of hospital stay, up to 24 weeks|Only subjects capable of performing the ICU-SEQ were provided the assessment. Seven subjects were excluded.|||units on a scale||Full Range|Median
1464646|NCT00744328|Primary|To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29|Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology.|Week 8|Analyses presented are Last Observation Carried Forward. For women who completed the 8 week trial the percent change was measured from baseline to week 8. For non-completers, the percent change was measured from baseline to last observation.|||percentage change in SIGH-ADS29 Score||Standard Deviation|Mean
1464647|NCT00744263|Other Pre-specified|Percentage of Participants With Newly Diagnosed Chronic Medical Condition|Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.|From 1 month after vaccination up to 6 months after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.|||percentage of participants|||Number
1464648|NCT00744263|Other Pre-specified|Percentage of Participants Who Died|Deaths collected throughout the case acquisition period were presented.|From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Safety population included all participants who received study vaccine and who had any safety data.|||percentage of participants|||Number
1464649|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination|Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.|Within 7 days after vaccination|Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.|||percentage of participants||95% Confidence Interval|Number
1464650|NCT00744263|Other Pre-specified|Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination|Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.|Within 7 days after vaccination|Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.|||percentage of participants||95% Confidence Interval|Number
1464651|NCT00744263|Secondary|Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases|VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).|Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
1464652|NCT00744263|Secondary|Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.|Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
1464711|NCT00743340|Primary|Number of Participants Who Had Access to, and Received the Intervention|This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.|Up to 586 weeks|Participants who were enrolled into the study and received study drug.|||Participants|||Count of Participants
1507944|NCT00413634|Primary|Terminal Half-life (T 1/2) of Agrylin||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
1464653|NCT00744263|Primary|Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)|CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).|Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)|Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.|||participants|||Number
1464654|NCT00744237|Secondary|Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5|[visit 5(week 0) and visit 14(week 26)]||||Unit on a scale||Standard Deviation|Mean
1464655|NCT00744237|Primary|Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26|Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.|visit 5(week 0) and visit 14(week 26)||||Percentage||Standard Deviation|Mean
1464656|NCT00744211|Other Pre-specified|Number of Other Adverse Events By Type|Other (non-serious) Adverse Events (reported by arm/group)|up to 24-hours post-CPB||||events|||Number
1464657|NCT00744211|Other Pre-specified|Sitaxsentan Levels|Sitaxsentan levels (microg/mL)|0, 6, 12 and 24 hours post-CPB||||microg/mL||Standard Deviation|Mean
1464658|NCT00744211|Secondary|Plasma Endothelin-1|Plasma Endothelin-1 (fmol/mL)|Baseline, 0, 6, 12 and 24 hours post-CPB||||fmol/mL||Standard Deviation|Mean
1464659|NCT00744211|Primary|Pulmonary Vascular Resistance|Pulmonary Vascular Resistance (d.s.cm-5)|Baseline, 0, 6, 12 and 24 hours post-cardiopulmonary bypass (CPB)||||dyne*second/centimeter˄5||Standard Deviation|Mean
1464660|NCT00744055|Primary|Clinician-Administered PTSD Scale|Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). A higher score is associated with higher severity of PTSD. The score is interpreted as follows: 0-19=Asymptomatic/few symptoms 20-39=Sub-threshold/mild PTSD 40-59=Threshold PTSD/moderate 60-79=Severe PTSD >80=Extreme PTSD|12 weeks||||units on a scale||Standard Deviation|Mean
1464661|NCT00744055|Primary|Number of Drinking Days|Using the Timeline Follow Back method, a calendar method for assessing drug and alcohol use|12 weeks||||days||Standard Deviation|Mean
1464662|NCT00744042|Secondary|Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)|Area under serum concentration-time curve to last measurable concentration during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||h*U/L||Standard Deviation|Mean
1464663|NCT00744042|Secondary|Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)|Time at maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose).|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||hour||Standard Deviation|Mean
1464664|NCT00744042|Secondary|Maximum Serum Concentration of Asfotase Alfa (Cmax)|Maximum serum concentration observed during intensive PK sampling interval.|Study Week 1 (0 to 168 hours post-dose). Study Week 2 and Study Week 3 (0 to 48 hours post-dose)|ITT population. N=number of patients who received a full dose of asfotase alfa and had sufficient data for non-compartmental analysis.|||U/L||Standard Deviation|Mean
1464665|NCT00744042|Primary|Change in Rickets Severity From Baseline to Week 24, Based on Assessment of Skeletal Radiographs Using Radiologic Global Impression of Change (RGI-C)|"A 7-point RGI-C (Radiographic Global Impression of Change) score was used to rate change in rickets severity. Scores ranged from -3 (severe worsening of rickets) to +3 (complete healing of rickets). Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings. Average scores were derived for each patient at each assessment."|24 weeks|ITT (intention to treat)|||Units on a scale||Full Range|Median
1464666|NCT00743730|Secondary|Parent Satisfaction With the Administration Technique|Parents were asked “Overall, how satisfied were you with the pain relief your child received after surgery?” Response options were: 1. Very Dissatisfied, 2. Dissatisfied, 3. Satisfied, 4. Very Satisfied. Responses were scored on a 1-4 scale, with Very Dissatisfied = 1; Dissatisfied = 2; Satisfied = 3; Very Satisfied = 4.|parents, once at the end of study|Data was obtained from parents who completed the satisfaction survey|||units on a scale||Standard Deviation|Mean
1464667|NCT00743730|Secondary|Number of Patients Requiring Naloxone for Respiratory Depression|Number of patients requiring naloxone for respiratory depression (our most important side effect)|Daily, for up to 3 days||||Participants|||Count of Participants
1464668|NCT00743730|Primary|Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale|Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0–10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.|First 24 hours on study||||units on a scale||Inter-Quartile Range|Median
1464669|NCT00743717|Primary|Knee Score at 2 Years Post Operation|"The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) > 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score > 80 was used as a criterion to assess success."|within 2 years||||units on a scale||Full Range|Mean
1464670|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose||28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
1464671|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose||28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
1464672|NCT00743652|Other Pre-specified|Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series||28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Correlative analysis output data are only available as figures and were not analyzed or presented statistically.|||Participants|||Number
1464673|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose|Antibody geometric mean titers as measured by OPA assay for 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
1464674|NCT00743652|Other Pre-specified|Pneumococcal OPA GMTs 1 Month After the Toddler Dose|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all subjects with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
1464675|NCT00743652|Other Pre-specified|Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series|Antibody geometric mean titers as measured by OPA assay for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMTs were calculated using all participants with available data for the specified blood draw. CIs for the GMTs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the titers.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Titers||95% Confidence Interval|Geometric Mean
1464676|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464677|NCT00743652|Other Pre-specified|Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464678|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving OPA with 95% CI for serotypes 4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F, and 19A. Exact 2-sided CI based upon the observed proportion of participants. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Limit of detection (LOD) established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464728|NCT00743119|Primary|Pain Tolerance|Change in pain tolerance from baseline (in seconds) as a function of drug condition. The cold pressor test was administered during each session to examine changes in pain threshold (how many seconds it takes for a participant to begin feeling pain after cold water immersion).|Within each session lasting approximately 5 minutes, for a total of five sessions|All participants who completed the study (N=30) were included in the final analysis.|||seconds||Standard Error|Mean
1464679|NCT00743652|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1464680|NCT00743652|Other Pre-specified|GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A). GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1464681|NCT00743652|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series|Antibody GMCs (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) with 2-sided 95% CIs were evaluated. CIs are back transformations of confidence levels based on Student t distribution for mean logarithm of concentrations. GMCs were calculated using all participants with available data for specified blood draw.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the specified serotype.|||mcg/mL||95% Confidence Interval|Geometric Mean
1464682|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464683|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464684|NCT00743652|Other Pre-specified|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.15 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464685|NCT00743652|Other Pre-specified|Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC|In order to assess the impact of 13vPnC on the incidence of IPD in the Yukon Kuskokwim (YK) Delta region, the Centers for Disease Control and Prevention (CDC) Arctic Investigation Program (AIP) accessed IPD data through evaluation of ongoing statewide IPD surveillance in Alaska. The CDC’s AIP followed IPD (including serotype and vaccination history) to show whether identified cases of IPD received Prevnar, 13vPnC, or both. These data were combined with statewide data and used to identify the overall trend in IPD in the YK Delta region after introduction of 13vPnC.|Baseline to 6 months after last vaccination|Safety Population|||Participants|||Number
1464686|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2|Systemic events (any fever 38 degrees C or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1464687|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1|Systemic events (any fever 38 degrees Celsius [C] or higher, decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], and use of antipyretic medication) were reported using a diary card. Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1468202|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 2 Years|Number of participants with clinically significant infections at 2 years|2 years post transplant||||Participants|||Count of Participants
1464688|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 2 for Group 4|Safety Population; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1464689|NCT00743652|Secondary|Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1|Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.|Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5.|Safety Population: all participants who received at least 1 dose of 13vPnC; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants with specific characteristic|||Percentage of Participants|||Number
1464690|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464691|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464692|NCT00743652|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥1.0 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464693|NCT00743652|Secondary|Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464694|NCT00743652|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose|Percentage of participants in 13vPnC Groups 4 and 5 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464695|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose|Percentage of participants in 13vPnC Groups 1, 2, and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3.|Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464709|NCT00743431|Primary|Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)|"Definitions in assessment of adverse event severity:~Mild: awareness of sign, symptom, or event, but easily~tolerated.~Moderate: discomfort enough to cause interference with usual~activity and may warrant intervention.~Severe: incapacitating with inability to do usual activities or~significantly affects clinical status, and warrants~intervention."|The observational program was conducted over a period of 2 years|Intent-to-treat (ITT) (N=214). This is also the Safety population.|||Events|||Number
1464729|NCT00743106|Secondary|Postoperative Creatinine (mg/dL)|assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)|4-days post-operatively||||mg/dL||Standard Error|Mean
1464696|NCT00743652|Primary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants in 13vPnC Groups 1, 2 and 3 achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based upon the observed proportion of participants.|28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3.|Evaluable immunogenicity population: received treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype.|||Percentage of Participants||95% Confidence Interval|Number
1464697|NCT00743574|Primary|AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months|AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT|3 months|Number determined by all participants who completed all interventions and procedures|||mg/min/120min||Standard Deviation|Mean
1464698|NCT00743574|Primary|AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months|Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT|3 months|Number determined by completion of all study interventions and procedures|||µIU/ml/120min||Standard Deviation|Mean
1464699|NCT00743574|Primary|Fasting Glucose Levels at Completion of Treatment, at 3 Months|Fasting glucose levels drawn after 3 months completion during oral GTT|3 months|Number determined based on all interventions and procedures completed.|||mg/dl||Standard Deviation|Mean
1464700|NCT00743574|Primary|Fasting Insulin Levels at Study Completion After 3 Month Treatment|Fasting insulin levels at study completion after 3 month treatment|3 months intervention|Number determined by all those who completed all interventions and procedures.|||µIU/ml||Standard Deviation|Mean
1464701|NCT00743574|Primary|Participants Were Assessed at Study Completion After 3 Month Treatment|Fasting HbA1C levels at study completion after 3 month treatment|Completion|Number determined by those who completed all interventions and procedures.|||percentage||Standard Deviation|Mean
1464702|NCT00743574|Secondary|Serum Levels of C-reactive Protein at Completion of 3 Months Treatment Compared to Baseline.|Serum levels of C-reactive protein upon completion, at 3 months|3 months|All subjects who completed treatment for 3 months|||mg/L||Inter-Quartile Range|Median
1464703|NCT00743509|Secondary|Median Overall Survival Time|Median overall duration of survival.|48 weeks|All patients who completed at least one 28 day cycle|||days||95% Confidence Interval|Median
1464704|NCT00743509|Primary|Number of Patients Alive Without Disease Progression|Patients who were evaluable for response to therapy, alive and without evidence of sarcoma disease progression. Target lesions followed were lesions that had progressed by World Health Organization (WHO) criteria. Disease progression is defined as a greater than or equal to 25% increase in the sum of the product of target lesions, or unequivocal progression of non-target lesions or the appearance of new tumor lesions >10mm.|6 months|Patients that tolerated and completed at least one 28 day cycle of therapy were considered evaluable|||participants|||Number
1464705|NCT00743483|Primary|The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)|"The absolute difference between baseline and treatment CFA, i.e. the change from the baseline level.~CFA was calculated as follows 100 x ((fat consumed - fat excreted)/fat consumed).~Fat consumed was determined from the weight of fat of the dietary intake during a 72 hour period during the final 3 days of the baseline and treatment period.~Fat excreted was determined from stool collected during the 72-hour periods and analyzed for fat using the Van de Kamer method.~The unit of CFA is %"|Final 3 days of baseline and treatment period|Per protocol|||% CFA||Standard Deviation|Mean
1464706|NCT00743444|Secondary|Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.|The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here.|0-12 hours post first dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 1 patient was excluded from the pharmacokinetic analysis due to error in dose administration at dose 2.|||μmol*hours / L||Standard Deviation|Geometric Mean
1464707|NCT00743444|Secondary|Total Number Reflux Episodes 0-24 Hours Post First Dose|Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.|0-24 hours|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from this analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 2 due to insufficient impedance/pH recording time.|||Episodes||95% Confidence Interval|Geometric Mean
1464708|NCT00743444|Primary|Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose|"The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133).~The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment."|0-3 hours post meal, post third dose|Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from the primary analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 1 due to low LESP, 1 due to multiple swallowing.|||Relaxations||95% Confidence Interval|Geometric Mean
1464710|NCT00743366|Primary|Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase|"This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.~Over each 3 day period, the puffs chosen by each participant is averaged for a single value."|Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)||||Puffs||Standard Error|Mean
1464712|NCT00743288|Primary|Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) [ORR= Complete Response (CR) + Very Good Partial Response (VGPR) + Partial Response (PR)]; CBR=ORR + Minimal Response (MR)] Following Treatment With Panobinostat and Melphalan|Responses were evaluated according to criteria modified from those developed by Blade et al., 1998 The reference point for evaluating response improvement is the baseline. This baseline reference point is also valid when a patient has already achieved a response and transitions through into a better response grade.|24 months||||participants|||Number
1464713|NCT00743288|Primary|MTD|Phase 1: to determine MTD of melphalan in combination with panobinostat to be used in the Phase 2 portion of the study|12 months||||mg/kg melphalan|||Number
1464714|NCT00743288|Primary|Maximum Tolerated Dose (MTD)|Phase 1: to determine the MTD of panobinostat (LBH589) in combination with melphalan to be used in the Phase 2 portion of the study|12 months|MTD for Melphalan and Panobinostat was reached in the cohort of 6 participants who received 20 mg/daily LBH589 PO and melphalan PO at 0.05 mg/kg on days 1, 3 and 5 of week 1 of each cycle. Three additional patients were enrolled as part of the phase 2 expansion.|||mg LBH589|||Number
1464715|NCT00743288|Secondary|Time to Progression||Time from the start of treatment to progressive disease|All cohorts were analyzed|||months||Full Range|Median
1464716|NCT00743288|Secondary|Duration of Response||First evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death|Only three patients had responses.|||months||Full Range|Median
1464717|NCT00743275|Primary|Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)|Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation|21 days post-vaccination|Analysis of seroconversion was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Percentage of Participants|||Number
1464718|NCT00743275|Primary|Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)|Seroprotection was defined as post-vaccination titer value of ≥ 1:40.|21 days post-vaccination|Analysis of seroprotection was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Percentage of Participants|||Number
1464719|NCT00743275|Primary|Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation||Day 0 and 21 days post-vaccination|Analysis of Geometric Mean Titers was in the per-protocol population. (Participants that did not provide both pre- and post- vaccination serum samples within the specified time window were excluded from analysis)|||Titers||95% Confidence Interval|Geometric Mean
1464720|NCT00743275|Primary|Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.|Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering|Days 0-3 post-vaccination|Safety profile was assessed in the intent-to-treat (ITT) population|||Participants|||Number
1464721|NCT00743262|Secondary|Device Life Time|Device life time of the Provox Vega in days for replacement for leakage through the device. This is expected to be short (average about 3 weeks) since the Provox Vega 22.5 was tested in patients who normally use a Provox ActiValve. (Provox ActiValve is a problem solving prostheses used in patients who need frequent replacement of regular Provox voice prostheses short that are made of the same materials as the Provox Vega 22.5.)|one year||||days||Standard Deviation|Mean
1464722|NCT00743262|Secondary|Subjective Voice and Speech Quality|Subjective participant opinion using a structured questionnaire addressing intelligibility face to face and on the phone, loudness, pitch and fluency. Each question was measured on a four point scale. Scores were summated, best possible score is 5, worst possible score is 20.|3 weeks||||units on a scale||Standard Deviation|Mean
1464723|NCT00743262|Primary|Short-term Feasibility Provox Vega 22.5 French|Number of participants in whom the voice prosthesis was considered feasible in the short-term with regards to clinical and technical aspects as judged by patient and investigator.|3 weeks||||Patients|||Number
1464724|NCT00743249|Secondary|Percentage of Subjects Retaining the Stent at Month 3|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|Month 3|Intent to treat|||Percentage of subjects|||Number
1464725|NCT00743249|Primary|Mean Retention Time|At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.|From baseline (Day 0) up to Month 3|Intent to treat|||Days||Standard Deviation|Mean
1464726|NCT00743197|Secondary|The Role and Function of Endothelial Progenitor Cells (EPCs) in the Presence of Proven Endothelial Dysfunction and the Response of EPCs to Medical Therapy for Endothelial Dysfunction.|no analyses were conducted due to the PI's departure from the institution; all work including analyses ceased upon departure- the study was not transferred with the PI. In addition, the study end points were based on changes between groups (treatment vs. usual care group) at 12 month follow up for both groups - none of the enrolled subjects made it to the final (month 12) visit.|1 year|||||||
1464727|NCT00743197|Primary|Effectiveness of Therapy Compared to Usual Care, in Those Women With Chest Pain (CP), Reversible Ischemia by Stress Testing and Nonobstructive Coronary Artery Disease (CAD) by Angiography Who Are Found to Have Coronary Endothelial Dysfunction (CED).|The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain (CP), coronary endothelial dysfunction (CED) and unblocked coronary arteries. CED is a condition in which the layers of cells around the heart do not function properly and is believed to be a key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for suture cardiovascular events, such as heart attack and stroke.|1 year|no analyses were conducted due to PI's departure from institution;all work including analyses ceased upon departure-the study was not transferred with the PI. In addition, study end points were based on changes between groups (treatment vs. usual care)at 12-mo follow up for both groups- none of the enrolled subjects completed the month 12 visit.|||participants|||Number
1509284|NCT00405288|Secondary|Gestational Age at Delivery|Fetal gestational age at delivery|until delivery||||gestational weeks||Standard Deviation|Mean
1464730|NCT00743106|Primary|Glomerular Filtration Rate (GFR) Percentage of Change From Baseline|Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.|percentage of change from baseline to post-operatively day 3||||percentage change||Standard Deviation|Mean
1464731|NCT00743093|Secondary|The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).||Days 1-3|A subset of the safety population was monitored for early detection of APAP-cys. This subset of subjects had APAP-cys measured at Days 1, 2, and 3 in addition to other protocol defined timepoints.|||participants|||Number
1464732|NCT00743093|Primary|The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.|ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.|serial samples for 16-40 days|The total number of subjects completing the trial was used for analysis. Subjects who withdrew early were not included.|||participants|||Number
1464733|NCT00742963|Primary|Maximum Tolerated Dose (MTD) Measured of TH-302 When Used in Combination With Doxorubicin and Prophylactic Growth Factor Support in Subjects With Advanced Soft Tissue Sarcoma||Two years||||mg/m2|||Number
1464734|NCT00742924|Secondary|Prognostic Value of Bone Resorption Markers|Blood will be collected for quantification of c-telopeptide and urine will be collected for quantification of n-telopeptide.|At baseline and at weeks 13 and 36|||||||
1464735|NCT00742924|Secondary|Secondary Limiting Toxicity|"Secondary limiting toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor.~CTC AE version 4 hematologic toxicity will be based on time to blood count recovery to an ANC ≥ 1000/µL and platelet count ≥ 100,000/µL that delays definitive surgery by more than 2 weeks."|After week 13 to the end of protocol therapy|||||||
1464736|NCT00742924|Secondary|Event-free Survival|The EFS and survival functions will be estimated by the Kaplan-Meier methodology.|Time from study enrollment to disease recurrence, death without disease progression, diagnosis of a second malignant neoplasm, assessed up to 5 years|||||||
1464737|NCT00742924|Secondary|Histologic Response as Assessed in the Primary Tumor and in Resected Metastases|"Histologic response as graded according to the system of Huvos across all specimens resected at the time of local control in the primary tumor and in resected metastases.~The best response, as quantified by maximum necrosis grading according to the system of Huvos across all specimens resected at the time of local control, will be used to quantify the effect of Induction chemotherapy."|At definitive surgery planned for 12 weeks after the start of protocol therapy.|||||||
1464738|NCT00742924|Primary|Limiting Toxicity|"The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of:~Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis.~Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 fever or infection.~Grade 3 or 4 hypocalcemia (see Section 5.1.1)~Grade 3 mucositis.~Grade 3 fatigue that returns to ≤ Grade 2, before the planned dose of therapy after definitive surgery.~Grade 3 joint range of motion, decreased or joint effusion that is related to the primary tumor."|Enrollment through the first 12 weeks of therapy.|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome|||participants|||Number
1464739|NCT00742885|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the entire study period (Day 0 to Day 181)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464740|NCT00742885|Secondary|Number of Subjects Reporting Any Medically-significant Conditions (MSCs)|MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.|During the 182-day (Days 0-181) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464741|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|From Day 0 to Day 83 following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464793|NCT00742508|Primary|Mean Change From Baseline in Weight at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||kilograms (kg)||Standard Deviation|Mean
1464742|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) following vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464743|NCT00742885|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464744|NCT00742885|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).|During the 7-day post vaccination period (Days 0-6) after any vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464745|NCT00742885|Secondary|Number of Subjects With Any Normal or Abnormal Urine Values|Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464746|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464747|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464748|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|"Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC).~Categories = unknown, below, within, or above the normal ranges."|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464749|NCT00742885|Secondary|Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities|Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.|At Day 0, Day 7 and Day 42|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
1464750|NCT00742885|Secondary|Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies|"A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182.~The H5N1 vaccine strain included A/Indonesia antigen."|At Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
1464751|NCT00742885|Secondary|Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 42 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Titer||95% Confidence Interval|Geometric Mean
1464752|NCT00742885|Secondary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
1464753|NCT00742885|Secondary|Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Fold Increase||95% Confidence Interval|Geometric Mean
1464853|NCT00742170|Primary|Percent of Participants Using Drugs||2 weeks following discharge||||percent|||Number
1464754|NCT00742885|Secondary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Participants|||Count of Participants
1464755|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0, Day 21 and Day 182|Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.|||Titer||95% Confidence Interval|Geometric Mean
1464756|NCT00742885|Primary|Number of Subjects Seroprotected for H5N1 HI Antibodies|A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1464757|NCT00742885|Primary|HI Antibody Seroconversion Factors for H5N1 HI Antibodies|Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Fold Increase||95% Confidence Interval|Geometric Mean
1464758|NCT00742885|Primary|Number of Subjects Seroconverted for H5N1 HI Antibodies|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.|At Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Participants|||Count of Participants
1464759|NCT00742885|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).|At Day 0 and Day 42|Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1464760|NCT00742872|Primary|Adequate Relief of Symptoms Associated With Constipation-predominant Irritable Bowel Syndrome.||Within the first 8 weeks of treatment||||participants|||Number
1464761|NCT00742859|Secondary|Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)|The time to the first occurrence of any bleeding event. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.|||Number of Patients per 100 Patient years||95% Confidence Interval|Number
1464762|NCT00742859|Primary|Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode|The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.|A maximum of 1 year|All randomized patients who took at least 1 dose of study medication after randomization.|||Number of Patients per 100 Patient years||95% Confidence Interval|Number
1464763|NCT00742781|Primary|25(OH)D3 Serum Levels|25(OH)D3 levels before and after vitamin D supplementation.|6 months||||ng/ml 25(OH)D3||Standard Error|Mean
1464764|NCT00742781|Secondary|Health Improvement|International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.|6 months|Activity records for 14 participants were recorded at baseline and after vitamin D supplementation.|||units on a scale||Standard Error|Mean
1464765|NCT00742781|Primary|Crohn's Disease Activity Index|Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.|6 months||||units on a scale||Standard Error|Mean
1464766|NCT00742625|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
1464767|NCT00742625|Secondary|Disease-free Survival|Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)||||months||95% Confidence Interval|Median
1464768|NCT00742625|Primary|Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine|"DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs.~Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death."|during consolidation cycle 1 (42 days)|Participants who were registered to bortezomib consolidation were included in the analysis.|||participants|||Number
1464769|NCT00742625|Primary|Remission Induction Response|"Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML)~A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction.~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL).~A CRp is defined as a CR except platelets < 100,000 mL without need for transfusion."|2 months||||participants|||Number
1464770|NCT00742560|Secondary|Plasma Cell Myeloma Cytogenetic Subtype|Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System [ISS] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age < 55).|Screening (up to 14 days prior to dosing)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
1464771|NCT00742560|Secondary|Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)|Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided.|From screening through 60-day follow up period (up to 101 months)|All participants who received at least one dose of study drug and with at least one evaluable post-dose sample.|||percentage of participants|||Number
1464772|NCT00742560|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1464773|NCT00742560|Secondary|Time to Progression (TTP)|TTP is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression. The distribution of TTP was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the TTP distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1464774|NCT00742560|Secondary|Duration of Response|Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided.|From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
1464775|NCT00742560|Secondary|Serum Half-life (t1/2) of Elotuzumab|The serum half-life of a drug (t1/2, measured in hours) is the time necessary to reduce the plasma concentration by half. The t1/2 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1464776|NCT00742560|Secondary|Volume of Distribution (V) of Elotuzumab|Volume of distribution (V, measured in L/kg) is the hypothetical volume of body fluid that would be required to dissolve the amount of drug needed to achieve the same concentration in the blood. The V of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1464777|NCT00742560|Secondary|Systemic Clearance (CL) of Elotuzumab|Systemic clearance (CL, measured in mL/kg/hr) is a measure of the efficiency with which a drug is irreversibly removed from the body. The CL of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1466214|NCT00732940|Secondary|Absolute Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
1464778|NCT00742560|Secondary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab|The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1464779|NCT00742560|Secondary|Maximum Serum Concentration (Cmax) of Elotuzumab|The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.|Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1|No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated (collected data not reliable due to assay limitations caused by sparse serum concentrations).||||||
1464780|NCT00742560|Secondary|Mean Serum Concentrations of Elotuzumab During Cycle 1|Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose.|Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)|Safety population: All randomized participants who received at least 1 dose of study drug, with evaluable data at given time point.|||μg/mL||Standard Deviation|Mean
1464781|NCT00742560|Secondary|Number of Participants With Infusion Reactions|During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).|Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
1464782|NCT00742560|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)|Safety population: All randomized participants who received at least 1 dose of study drug|||participants|||Number
1464783|NCT00742560|Secondary|Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)|ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).|From first dose of elotuzumab until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months|Safety population: All randomized participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1464792|NCT00742508|Primary|Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8|There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
1464784|NCT00742560|Primary|Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)|ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).|From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months|Safety population: All randomized participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
1464785|NCT00742560|Primary|Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)|MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity [DLT]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets < 10,000 cells/mm^3 that do not recover to 25,000 cells/mm^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used.|4 weeks|All participants in the safety population (all randomized participants who received at least 1 dose of study drug) in the escalation cohorts (Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone [Phase 1]; and Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone [Phase 1]).|||mg/kg|||Number
1464786|NCT00742508|Secondary|Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8|Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.|||percentage||Standard Deviation|Mean
1464787|NCT00742508|Secondary|Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8|Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group). Some participants in each treatment arm withdrew prematurely.|||ng/L (nanogram per Liter)||Standard Deviation|Mean
1464788|NCT00742508|Secondary|Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8|The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.|Baseline and Week 8|Efficacy Population: all participants measurable at the efficacy endpoints (20 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
1464789|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|PD Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||beats per minute||Standard Error|Mean
1464790|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||millimeters of mercury (mmHg)||Standard Error|Mean
1464791|NCT00742508|Primary|Cardiothoracic Ratio at Baseline and Week 8|Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage||Standard Deviation|Mean
1466215|NCT00732940|Secondary|Median Percent Change From Baseline in HDL at Week 24||Baseline, 24 week|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1464794|NCT00742508|Primary|Mean Change From Baseline in Heart Rate at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||beats per minute||Standard Deviation|Mean
1464795|NCT00742508|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1464796|NCT00742508|Primary|Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8|Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||participants|||Number
1464797|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Volume at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||femtoliters (fL)||Standard Deviation|Mean
1464798|NCT00742508|Primary|Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||picograms (pg)||Standard Deviation|Mean
1464799|NCT00742508|Primary|Mean Change From Baseline in Red Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||tebi (2 to the power of 40)/liter (Ti/L)||Standard Deviation|Mean
1464800|NCT00742508|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||gibi (2 to the power of 30)/liter (Gi/L)||Standard Deviation|Mean
1464801|NCT00742508|Primary|Mean Change From Baseline in Hematocrit at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||proportion of 1 (SI)||Standard Deviation|Mean
1464802|NCT00742508|Primary|Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||grams per liter (g/L)||Standard Deviation|Mean
1464803|NCT00742508|Primary|Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage of each WBC type in WBC count||Standard Deviation|Mean
1464804|NCT00742508|Primary|Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||percentage of Total Creatine Kinase||Standard Deviation|Mean
1464805|NCT00742508|Primary|Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1464806|NCT00742508|Primary|Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||micromoles per liter (umol/L)||Standard Deviation|Mean
1464807|NCT00742508|Primary|Mean Change From Baseline in Amylase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||units per liter (U/L)||Standard Deviation|Mean
1507945|NCT00413634|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Agrylin||over 1 day|PK population|||ng.h/ml||Standard Deviation|Geometric Mean
1464808|NCT00742508|Primary|Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||international units per liter (IU/L)||Standard Deviation|Mean
1464809|NCT00742508|Primary|Mean Change From Baseline in Albumin and Total Protein at Week 8|Mean change from baseline was calculated as the Week 8 value minus the Baseline value.|Baseline and Week 8|Safety Population: 22 participants at baseline and 11 participants at Week 8 in the CRV-IR group; 19 participants at baseline and 8 participants at Week 8 in the SK&F-105517-D group. Some participants in each treatment arm withdrew prematurely.|||grams per liter (g/L)||Standard Deviation|Mean
1464810|NCT00742508|Secondary|Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8|Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.|Baseline and Week 8|Pharmacodynamic (PD) Population: all participants measurable at the PD endpoints (18 participants at baseline and 3 participants at Week 8 in CRV-IR group, 19 participants at baseline and 4 participants at Week 8 in SK&F-105517-D group)|||millimeters of mercury (mmHg)||Standard Error|Mean
1464811|NCT00742508|Secondary|Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 in group F who gave samples at Week 8 in the CRV-IR group; total of 15 participants, including 4 in group C who gave samples at Week 8 in the SK&F-105517-D group|||hours||Full Range|Median
1464812|NCT00742508|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Area under the plasma concentration versus time curve from time zero to 24 hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|Pharmacokinetic (PK) Parameter Population: all participants who received the study drug at each dose level and provided sufficient PK concentration data and the data for estimation of PK parameters (total of 13 participants, 3 gave samples at Week 8 in CRV-IR group; total of 15 participants, 4 gave samples at Week 8 in the SK&F-105517-D group)|||hours * nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1464813|NCT00742508|Secondary|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8|Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.|Week 8|PK Parameter Population: total of 13 participants, including 3 who gave samples in group F at Week 8 in CRV-IR group; total of 15 participants, including 4 who gave samples at Week 8 in the SK&F-105517-D group)|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
1464814|NCT00742508|Primary|Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)|Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.|Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D|Safety Population: all participants who received at least one dose of the investigational product|||participants|||Number
1464815|NCT00742417|Secondary|Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)|Percentage of patients with improved perfusion at the end of the study compared to their initial perfusion. Frontal, parietal and temporal lobes were evaluated from the quantified NeuroGam images. This rendered parametric images showed brain alterations with more than 2 standard deviations with respect to a normal data base. Initial parametric images were compared to the final ones and it was considered perfusion improvement those patients that showed less stretch and/or defect intensity.|End of study|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients|||percentage of participants|||Number
1464816|NCT00742417|Secondary|Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.|Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by Magnetic Resonance Imaging (MRI). Three measurements were made (week -2 or -1, 20 and 44). It was measured the variations versus the baseline.|Week 00 (baseline), week 20 and week 44|We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients|||cubic centimetres (cc)||Standard Deviation|Mean
1464854|NCT00742079|Secondary|Change in the Maudsley Assessment of Delusions Scale|This scale is a one-question item added on to the Bead Task. The one item asks for a certainty rating, from 1-3. Higher scores represent better outcomes.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1464817|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~ADCS-ADL: Alzheimer’s Disease Cooperative Study/Activities Of Daily Living (23 questions describing daily activity of the subject and requests the informer to describe the actions or behaviors observed. Increased autonomy associated to higher scores, maximum of 78 points and minimum of 0)~NPI: Neuropsychiatric Inventory Questions (12 symptom domains scored by frequency [range=0 to 4, higher values being more frequent] and severity [range=1 to 3, higher values being more severe], total score is sum of frequency x severity of all domains)~CDR-Sb: Clinical Dementia Rating (range=0 to 3, higher values being more severe)~ADCS-CGIC: Alzheimer’s Disease Cooperative Study/Clinical Global Impression of Change (7-point Likert scale, 0=not assessed, 1=marked improvement, 2=moderate improvement, 3=minimal improvement, 4=no change, 5=minimal worsening, 6=moderate worsening and 7=marked worsening)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||units on a scale||Standard Deviation|Mean
1464818|NCT00742417|Secondary|Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)|"Change in the cognitive, functional and neuropsychiatric scores and overall development.~MMSE: Mini Mental State Examination Score (range = 0 to 30, with lower values indicating impairment)~ADAS-Cog: Alzheimer’s Disease Assessment Scale, Cognitive Subscale (range = 0 to 70, with higher values indicating impairment)~NPS (Neuropsychological battery): •SDMT (Symbol Digit Modalities Test, range = 0 to 110, with lower values indicating impairment), •SVF (Semantic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •PVF F, A and S (Phonetic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •BNT (Boston Naming Test, with a maximum of 15 pictures), •RAVLT (Rey Auditory Verbal Learning Test, with 15 words the patient should listen and remind)~CSDD (Cornell Scale for Depression in Dementia, 0 = none; 1 =mild or intermittent; 2 = severe)"|Change from baseline at week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||units on a scale||Standard Deviation|Mean
1464819|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (Innotest).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using Innotest commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1464820|NCT00742417|Secondary|Aβ1−42 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1464821|NCT00742417|Secondary|Aβ1−40 Plasma Levels Before and After Each Study Period (The Genetics Company).|Plasma levels of Aβ1−40 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).|Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1464822|NCT00742417|Secondary|P-Tau and Tau CSF Levels Throughout the Study.|Levels of Tau and P-tau in CSF throughout the treatment phase and the follow-up phase (week 44).|Baseline, week 02, week 08, week 20, week 33 and week 44|The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||Standard Deviation|Mean
1464823|NCT00742417|Primary|Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.|Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.|Baseline and up to week 44|The efficacy analyses were performed with the full analysis set (FAS) population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions (or sham procedures) during the intensive treatment phase (the three first weeks of treatment).|||pg/mL||95% Confidence Interval|Least Squares Mean
1464824|NCT00742391|Secondary|Patients With Partial Clearance of Actinic Keratosis (AKs)|Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.|baseline and 57 days|Intention to treat population|||participants|||Number
1464825|NCT00742391|Primary|Patients With Complete Clearance of Actinic Keratosis (AKs)|Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.|57 days|Intention to treat population|||Participants|||Number
1464826|NCT00742326|Secondary|Change in Insulin Resistance in HIV- and HCV-infected Patients With Steatosis Compared to Placebo|Change in Glucose Area Under the Curve from standard oral glucose challenge ( baseline to 2 hours): Week 48 - Baseline values|48 weeks|One subject in the placebo arm was discontinued due to health issues and does not have a 48 week OGTT available|||mg*120 minutes/dL||Standard Deviation|Mean
1464827|NCT00742326|Primary|Change in Hepatic Steatosis and Hepatic Inflammation/Fibrosis in HIV/HCV Co-infected Patients With Steatosis.|Change in hepatic steatosis and hepatic inflammation/fibrosis in HIV/HCV co-infected patients with steatosis. Change in Hepatic Fat Content measured by MR spectroscopy: 48 weeks compared to Baseline|48 weeks|Two subjects (one in each group) did not have a follow up MRI for comparision to baseline. One developed claustrophobia and could not tolerate MRI and one was discontinued from study due to other illnesses.|||percentage of hepatic fat on MRS||Standard Deviation|Mean
1464828|NCT00742313|Primary|Number of Participants With Decreased Bleeding|The number of participants with less than expected bleeding (bleeding typically expected for the vein grafting procedure) at the surgical site. Blood was collected in the Blake drain of the EVH wound bed treated with FloSeal MatrixFloSeal Matrix™in the tunnel of the endoscopically harvested Greater Saphenous vein.|14 days|Six participants were not analyzed due to early termination of study|||participants|||Number
1464829|NCT00742274|Primary|Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation|"Subjects with any of the following met this composite outcome:~partial/no false lumen thrombosis~aortic rupture~aortic dilatation~lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)"|1 year|Intent to Treat (ITT)|||participants|||Number
1464830|NCT00742235|Primary|Baseline 25-OH Vitamin D Level||Baseline||||ng/ml||Inter-Quartile Range|Median
1464831|NCT00742235|Primary|hCAP18 Levels||Baseline||||ng/ml||Standard Deviation|Mean
1464832|NCT00742209|Other Pre-specified|Assessment of Treatment Satisfaction Using the Patient Perception of Migraine Questionnaire (PPMQ-R) at Week 17|"Three global treatment satisfaction items from the PPMQ included satisfaction or dissatisfaction with Medication Effectiveness, Medication Side Effects, and Overall Medication. Each item on the PPMQ uses a 7-point satisfaction scale (1 = Very Satisfied to 7 = Very Dissatisfied). Satisfied participants include those reporting Very Satisfied (scale value = 1) or Satisfied (scale value = 2) on the scale."|Week 17|ITT Population|||Percentage of Patients|||Number
1464833|NCT00742209|Other Pre-specified|Mean Change From Baseline in Productivity as Measured by Lost Time Equivalents (LTE) - (Work Activities, Non-work Activities, and Combination of Work and Non-work Activities)|Productivity, as measured by LTE, is a metric used to assess productivity loss in migraine. It is a composite measure of presenteeism (continued to work while under the influence of migraine symptoms) and absenteeism (time missed from work due to migraine), and can be applied to productivity for work and non-work activities. Productivity data were collected via an e-diary, and productivity measures were summarized for each study phase by averaging each measure across migraine attacks for each participant.|Week 17|ITT Population|||Hours||Standard Error|Mean
1464834|NCT00742209|Other Pre-specified|Mean Change From Baseline in the Headache Impact Test (HIT-6) Total Scores at Week 17|The HIT is a 6-item, self-administered HRQOL questionnaire used to measure six areas that impact headaches have on participants' ability to function on the job, at school, at home, and in social situations. Participants provide responses to questions using a 5-point Likert-type scale. All item values range from 6 to13.The total scores range from 36 to 78, where higher scores indicate greater impact on a participant's life.|Week 17|ITT Population|||Points on a scale||Standard Error|Mean
1464835|NCT00742209|Other Pre-specified|Mean Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ v2.1) Composite Score and Subscales (Role Function Restrictive, Role Function, Preventive, & Emotional Function) at Week 17|The MSQ is a 14-item health-related quality of life (HRQOL) questionnaire. Participants provide responses using a 6-point Likert scale (1=None of the time, 2= A little bit of the time, 3=Some of the time, 4=A good bit of the time, 5=Most of the time, 6=All of the time) that are then recoded with a final item value where 1=6, 2=5, 3=4, 4=3, 5=2, and 6=1. The scale measures 3 independently scored dimensions (Role Function Restrictive, Role Function, Preventive, and Emotional Function) of HRQOL that are affected by migraine. For each dimension, a higher score indicates a better health status.|Baseline and Week 17|ITT Population|||units on a scale||Standard Error|Mean
1464836|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” (Responders) on the 7-point Likert Clinical Global Impression of Change (CGIC) Scale Using LOCF at Week 17|"The CGIC is a single question measured on a 7-point Likert Scale. (1 = “very much improved”; 2= much improved, and 7 = “very much worse”) designed to give an assessment of treatment from a clinician's perspective. A responder is defined as being 'Very much improved' or 'much improved'."|Week 17|ITT Population|||Participants|||Number
1464837|NCT00742209|Secondary|Number of Participants Who Were “Much Improved” or “Very Much Improved” on the 7-point Likert Patient Global Impression of Change (PGIC) Scale Using LOCF at Week 17|"The PGIC is a single question measured on the 7-point Likert Scale (1 = “very much improved”; 2 = much improved; 7 = “very much worse”). A responder is defined as being very much improved or much improved."|Week 17|ITT Population|||participants|||Number
1464838|NCT00742209|Secondary|Percentage of Participants Classified as Responders for Each of the Following Measures: Migraine Headache Days, Migraine Attacks, and Migraine Headache Periods|A responder is defined as a participant who achieved at least a 50% reduction from baseline for the indicated measures.|Baseline to the Last 4 weeks of treatment|ITT Population|||percentage of participants|||Number
1464839|NCT00742209|Secondary|Mean Change From Baseline in Percentage of Migraine Attacks With Each of the Following Migraine Symptoms: Aura, Nausea, Vomiting, Photophobia, Phonophobia|The endpoint is defined as the percentage of attacks with each symptom (separately) for each study phase. Migraine symptoms aura, nausea, vomiting, photophobia, and phonophobia are defined as the presence of each migraine symptom during any of the headache events within an attack.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Percentage of MA with migraine symptoms||Standard Error|Mean
1464840|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication Use|The Number of Acute Migraine Medication Doses Administered by Prescription Headache Medication use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Migraine Medication Doses||Standard Error|Mean
1464924|NCT00741039|Primary|Determine Response Rate of Patients > or = to 65 Yrs Diagnosed|For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).|8-16 weeks following vaccination.||||participants|||Number
1464841|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Opioid Use|The Number of Acute Migraine Medication Doses Administered by Opioid Use was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Days||Standard Error|Mean
1464842|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered by Triptan Use|The Number of Acute Migraine Medication Administered was measured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Migraine Medication Dose||Standard Error|Mean
1464843|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Acute Migraine Medication Doses Administered|The Number of Acute Migraine Medication Doses Administered was captured via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Acute Medication Doses Admin.||Standard Error|Mean
1464844|NCT00742209|Secondary|Mean Change From Baseline to the Last 4-Week Treatment Phase in the Number of Days of Acute Migraine Medication Use|The Number of Days of Acute Migraine Medication Use was assessed via the participant-assessed Daily Migraine Diary.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Days||Standard Error|Mean
1464845|NCT00742209|Secondary|Change From Baseline in the Mean Peak Migraine Pain Severity|Peak Migraine Pain Severity was measured using a 4-point scale (0=none, 1=mild, 2=moderate, or 3=severe) on a participant self assessed Daily Migraine Diary. The scale measured the maximum pain severity across all headache events considered to be one attack.. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Scores on a Scale||Standard Error|Mean
1464846|NCT00742209|Secondary|Change From Baseline in the Mean Migraine Attack Duration|The total duration of a migraine attack is measured from migraine attack onset until the resolution of the attack measured in hours and may include more than 1 headache event. The duration is assessed using a Daily Migraine Diary. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Hours||Standard Error|Mean
1464847|NCT00742209|Secondary|Mean Change From Baseline in the Number of Migraine Headache Periods (MHP)|A migraine headache period is a 24-hour block of time that begins at the onset of a migraine event . The 24-hour period is not linked directly with a calendar day. The change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache periods using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Headache Periods (MHP)||Standard Error|Mean
1464848|NCT00742209|Secondary|Adjusted Mean Change From Baseline in the Number of Migraine Attacks|A migraine attack is defined as a migraine headache of at least 30 minutes in duration and may also include recurring non-migraine or migraine headaches . Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine attacks using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Attacks||Standard Error|Mean
1464849|NCT00742209|Secondary|Mean Change From Baseline in the Number of MHD in All Study Phases|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline and the last 4 weeks of treatment prior to taper were calculated means of the number of migraine headache days using the Last Observation Carried Forward (LOCF). Change from baseline is calculated as post-baseline minus baseline. The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|ITT Population|||Migraine Headache Days (MHD)||Standard Error|Mean
1464850|NCT00742209|Primary|Adjusted Mean Change From Baseline in the Number of Migraine Headache Days (MHD) During the Last 4 Weeks of Treatment Prior to Taper|A migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Change from baseline was calculated as the mean number of MHD over the last 4 weeks of treatment prior to taper minus the number at baseline using the Last Observation Carried Forward (LOCF). The last 4-week treatment phase is based on the last 4 weeks prior to taper for each participant.|Baseline and last 4 weeks of treatment prior to taper (up to Week 17)|Intent to treat (ITT). There were 3 subjects who were randomized but did not take investigational product, and, therefore were not included in the Safety, ITT, or Per Protocol (PP) population.|||Migraine Headache Days (MHD)||Standard Error|Least Squares Mean
1464851|NCT00742183|Primary|Compare the Costs of Using the Interventions (Direct and Indirect)|"The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods.~The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr"|August 2008-August 2009|Primary analysis: the Intention To Treat (ITT) population will include all patients subject to at least one post-randomisation treatment and that provide some data for the primary endpoint. If there are any patients included which do not comply with the inclusion/exclusion criteria they will be included in the ITT population|||dollars||95% Confidence Interval|Mean
1464852|NCT00742170|Secondary|Opioid Craving (Self-report)|Self-report on scale of 3 to 30 (higher number indicates more craving)|at 2-weeks post discharge||||units on a scale||Standard Deviation|Mean
1464855|NCT00742079|Secondary|Change in Bead Task Score Measuring Probabilistic Reasoning|The Bead task is a reasoning task, where the number of beads guessed is the numeric value represented in the data. The lower end range is 1, and there is no upper range limit. Higher scores represent better outcomes.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1464856|NCT00742079|Secondary|Change in Beck Cognitive Insight Scale (BCIS)|"The BCIS is a 15-item self-report scale with Likert items 0-3. It consists of a composite score, where higher scores represent better outcomes, and there are 2 subscales: 1) Self-Reflectiveness (higher scores represent better outcomes) and 2) Self-Certainty (higher scores represent worse outcomes). The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty.~Step 1. Score every item on the BCIS from “0” to “3” according to the following rule:~“Do Not Agree at All” = 0, “Agree Slightly” = 1, “Agree a Lot” = 2, “Agree Completely” = 3 Step 2. Calculate self-reflectiveness subscale: sum items 1, 3, 4, 5, 6, 8, 12, 14, and 15.~Step 3. Calculate self-certainty subscale: sum items 2, 7, 9, 10, 11, and 13. Step 4. Calculate BCIS composite index: self-reflectiveness minus self-certainty."|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1464857|NCT00742079|Secondary|Change in Psychotic Rating Scales (PSYRATS) Delusion Score|The Delusions subscale is a 6 item clinician administered scale, with Likert items 0-4 and range is 0-24. Higher scores represent worse outcomes|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1464858|NCT00742079|Primary|Change in Alternative Beliefs Assessment|Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
1464859|NCT00742053|Primary|Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction|In order to determine correlation of PICC tip location with the intracatheter ECG, the PICC was advanced at 1cm increments and the p-wave observed for amplitude changes.|during catheter insertion||||cm||Standard Deviation|Mean
1464860|NCT00741988|Secondary|Characterization of the Toxicity in Patients With Previously Untreated Advanced NSCLC Treated With Ixabepilone and Carboplatin With and Without Bevacizumab.||18 months|||||||
1464861|NCT00741988|Secondary|Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death||18 months||||months||95% Confidence Interval|Median
1464862|NCT00741988|Secondary|Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease||18 months||||months||95% Confidence Interval|Median
1464863|NCT00741988|Primary|Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment|The Percentage of Patients Who Experience an Objective Benefit From Treatment|18 months||||percentage of participants||95% Confidence Interval|Number
1464864|NCT00741936|Secondary|Serum Glutamic Oxaloacetic Transaminase (SGOT)||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
1464865|NCT00741936|Secondary|Serum Glutamic Pyruvic Transaminase(SGPT) Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||U/L||Standard Deviation|Mean
1464866|NCT00741936|Secondary|Blood Creatinine Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||μmol/L||Standard Deviation|Mean
1464867|NCT00741936|Secondary|Blood Urea Level||Pre-treatment (Wk2) & Post-treatment (Wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||mmol/L||Standard Deviation|Mean
1464868|NCT00741936|Primary|Responder of Complete Spontaneous Bowel Movement (CSBM)|Patients with a mean increase of ≧1 complete spontaneous bowel movement(CSBM)/wk compared with the baseline(wk1-2) will be defined as responders. CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours.|End of treatment (wk10)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1464869|NCT00741936|Secondary|Success of Blinding|The success of blinding was evaluated for both investigator and patients as to whether MZRW or placebo had been taken.|End of follow-up (Wk18)|Only for subjects attended the last follow-up visit on Wk 18.|||participants|Participants||Number
1464870|NCT00741936|Secondary|Global Symptoms Improvement|"Participants were asked to rate their impression of change in constipation by comparing with their baseline (Wk2) at the visits during the treatment (Wk6), end of treatment (Wk10) and end of follow-up (Wk18) with scores from 0 to 6 represented markedly worse or better respectively. The response categories were collapsed to simply improved for score 4 to 6, same for score 3 or worse for score 0 to 2."|Wk 6, 10 & wk 18|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1464871|NCT00741936|Secondary|Changes on Individual Symptom Scores|It was a 7-point ordinal scale from 0=not at all to 6=very severe.|Baseline(Wk2), Within treatment(Wk6), End of treatment(Wk10) & End of follow-up(Wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||Units on a scale||Standard Deviation|Mean
1464925|NCT00741026|Secondary|Diastolic Blood Pressure|Diastolic Blood Pressure|3 Days||||mmHg||Standard Error|Mean
1464872|NCT00741936|Secondary|Complete Spontaneous Bowel Movement (CSBM)||Baseline(Wk1&2), Within treatment(Wk3-10), Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
1464873|NCT00741936|Secondary|Bowel Movement||Baseline(Wk1&2), Within treatment(Wk3-10) & Within follow-up(Wk11-18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||movements per week||Standard Deviation|Mean
1464874|NCT00741936|Secondary|Responder of Complete Spontaneous Bowel Movement (CSBM)|"Participants with a mean increase of complete spontaneous bowel movement (CSBM)>=1 movement per week compared with the last 14 days of the run-in period were defined as responders.~CSBM referred to the feeling that defecation led to complete passage of stool rather than partial or incomplete evacuation without the use of any laxative or enema within 24 hours."|End of follow up (wk18)|Statistical analysis was performed on the population being randomized and receiving allocated intervention. Missing values were imputed by the method of last observation carried forward.|||participants|||Number
1464875|NCT00741858|Primary|Physical Health Quality of Life|Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)|7 years||||units on a scale||Standard Error|Mean
1464876|NCT00741819|Secondary|Drug Administration Activities Questionnaire|Change in tasks from Baseline to Week 12. At Baseline and Week 12, subjects provided information related to the daily administration and time requirements of inhaled iloprost (Baseline) and inhaled treprostinil (Week 12).|Baseline and 12 weeks|Subjects who completed the questionnaire at Baseline and Week 12.|||minutes||Standard Deviation|Mean
1464877|NCT00741819|Secondary|World Health Organization (WHO) Functional Class|Change in WHO Functional Class (FC) from Baseline to Week 12. Data presented as percent of subjects who either improved FC, worsened FC, or had no change in FC from Baseline to Week 12.|Baseline and 12 Weeks|Subjects still enrolled at Week 12 with a WHO Functional Class at Baseline and Week 12.|||percentage of subjects|||Number
1464878|NCT00741819|Secondary|N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)|Change in NTpro-BNP from Baseline to Week 12. Blood samples were collected for plasma NTpro-BNP analysis during the study.|Baseline and Week 12|Subjects with a NTproBNP sample drawn at Baseline and Week 12|||pg/mL||Full Range|Median
1464879|NCT00741819|Secondary|Patient Impression of Change|The patient impression of change (PIC) was three single therapy-related questions related to the subjects overall impression of the transition from inhaled iloprost to inhaled treprostinil. Subjects were surveyed related to their overall impression of the transition from inhaled iloprost to inhaled treprostinil at Week 12.|Baseline and 12 weeks|Subjects who completed questionnaire at Baseline and Week 12|||percentage of patients|||Number
1464880|NCT00741819|Secondary|Treatment Satisfaction Questionnaire of Medication (TSQM)|Change in TSQM score from Baseline to Week 12. The TSQM is a validated instrument (Health and Quality of Life Outcomes 2004, 2:12) that measures major dimensions of patient satisfaction with medications. The questionnaire is comprised of 15 questions which fall into one of four categories; Effectiveness, Side-Effects, Convenience, and Global Satisfaction. Responses are scaled on a seven point bipolar scale from 'Extremely Satisfied' to 'Extremely Dissatisfied' where higher scores indicate improvements (total scores from 0-100). The questionnaire was completed at Baseline and Week 12. The Baseline questionnaire focused on the subject’s satisfaction with inhaled iloprost treatment, while the questionnaire completed at Week 12 focused on the subject’s satisfaction with inhaled treprostinil.|Baseline and 12 weeks|Subjects who completed the TSQM at Baseline and Week 12. Total analysis population was less for the Convenience Score (N=67) and Global Satisfaction Score (N=66).|||units on a scale||Full Range|Mean
1464881|NCT00741819|Secondary|Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)|Change in CAMPHOR Scores from Baseline to Week 12. The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning)and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and 12 weeks|Subjects who were still enrolled and completed the questionnaire at Baseline and Week 12. Total analysis population was less for the activity score and total score (N = 67).|||units on a scale||Full Range|Mean
1464882|NCT00741819|Secondary|Six-minute Walk Distance (6MWD)|Change in 6MWD from Baseline to Week 12. The 6-minute walk test (6MWT) was conducted at Baseline (10–30 minutes following the last dose of inhaled iloprost) and at Week 12 (10–60 minutes following the dose of inhaled treprostinil). The change in distance (meters) between Baseline and Week 12 is reported below.|Baseline and 12 weeks|Subjects enrolled at Week 12 visit.|||meters||Full Range|Median
1464883|NCT00741819|Primary|Number of Adverse Events|Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.|up to 24 months|All subjects who received at least one dose of inhaled treprostinil were included in the safety analysis population.|||number of events|||Number
1464884|NCT00741611|Secondary|Number of Participants With Acute Procedural Success in Mesh Treated Patients.|Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter|During the mesh ablation procedure|All mesh treated patients.|||participants|||Number
1464885|NCT00741611|Secondary|Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.|Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory.|12 months|All mesh treated patients.|||participants|||Number
1464886|NCT00741611|Primary|Number of Participants With Freedom From Symptomatic Atrial Fibrillation|Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable.|12 months|All treated patients||||||
1464926|NCT00741026|Secondary|Systolic Blood Pressure|Systolic Blood Pressure|3 Days||||mmHg||Standard Error|Mean
1464927|NCT00741026|Secondary|Heart Rate|Heart Rate|3 Days||||beats per minute||Standard Error|Mean
1464928|NCT00741026|Secondary|BMI|BMI|3 Days||||kg / m2||Standard Error|Mean
1464887|NCT00741611|Primary|Number of Participants With Serious Atrial Fibrillation Events|Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead.|12 months|All treated patients.|||participants|||Number
1464888|NCT00741611|Primary|Number of Participants With Major Complications|A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure.|12 months|Patients who were treated with the HD Mesh Ablation System|||participants|||Number
1464889|NCT00741598|Secondary|Quality of Life Satisfaction Questionnaire (Q-LES-Q)|"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.~The outcome measures presented are Q-LES-Q Total score = Sum of all scores from all 16 areas of functioning"|Screening||||units on a scale||Standard Deviation|Mean
1464890|NCT00741598|Secondary|The Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT is a brief measure of functional impairment. The total scale score is a sum of four items with range of scale from 0 to 26 (from no impairment to severe impairment).|Baseline, Weeks 4, 8, 12, and 16||||units on a scale||Standard Deviation|Mean
1464891|NCT00741598|Primary|The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16|"Conner’s CPT (Conner’s Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter X. The person must refrain from clicking if they see the letter X presented. Clicking to the letter “X” is a commission error, not clicking to other letters are omission errors.~The outcome measures presented are Total number of errors = Total number of omission + commission errors This outcome measure is presented at each study visit (baseline, week 4, week 8, week 12, and week 16)"|Measured at screening; baseline; and Weeks 4, 8, 12, and 16||||total number of errors||Standard Deviation|Mean
1464892|NCT00741598|Primary|Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16|"WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules.~The outcome measures presented are Total correct baseline = total correct card choices at baseline Total errors baseline = total erroneous card choices at baseline Total correct week 16 = total correct card choices at week 16 Total errors baseline = total erroneous card choices at week 16"|Measured at screening and Week 16||||number of card choices made||Standard Deviation|Mean
1464893|NCT00741598|Primary|Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16|"CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are:~CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16."|Measured at screening and Week 16||||number of total words remembered||Standard Deviation|Mean
1464894|NCT00741468|Primary|Plasma AUC Ratio of Day 1 and Day 8|"Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition.~For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used."|8 days|One subject had concentrations of Proellex (CDB-4124 and CDB-4453) that were below the lower level of quantitation at all time points tested and was excluded from the pharmacokinetic analyses.|||Ratio of geometric means Day 8 to Day 1||90% Confidence Interval|Mean
1464895|NCT00741390|Secondary|Reported Device Preference Within Lancing Pair at Visit 2|"After each pair of 4 lancings, the subject was asked: Which of the two devices did you find more comfortable, overall? The choices were: first lancing, second lancing or equivalent. The Stated Preference row indicates # of lancing pairs in which one device was preferred over the other device while the 2 rows below indicate the # of pairs in which each device was preferred. First and second device refers to the 1st and 2nd devices identified in column headers, not the device order during testing. The No Preference row includes lancing pairs with preference of equivalent or no answer."|Approximately Day 3 (Visit 2)|Comfort was analyzed per lancing pairs. 236 subjects performed up to 4 lancing pairs. 869 pairs were evaluated across the 4 arms. Pairs were excluded if they did not result in a valid meter reading or associated with protocol deviations or had missing comfort data.|||lancing pairs|||Number
1464896|NCT00741390|Secondary|Difference in Lancing Pain for Devices in Visit 2 Only. (For Subjects Assigned to Arm D Only)|"The subjects who participated in Study Visit 2 kept the same group assignment they had in Study Visit 1. Each subject tested 2 of the 3 systems they experienced during Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs.~After each pair of lancing, the subject was asked to record the difference in the pain they perceive between two lancing systems using the 150 mm visual analog scale. A positive value on the scale (and in the table below) indicates that the first device in the pair was more painful than the second."|Approximately Day 3 (Visit 2)|61 subjects in this arm completed visit 1 and evaluable data for lancing pain. See further description above.|||mm||Standard Deviation|Mean
1464929|NCT00741026|Secondary|Body Weight|Body Weight|3 Days||||kg||Standard Error|Mean
1464930|NCT00741026|Secondary|Total Cholesterol|Total Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
1464931|NCT00741026|Secondary|LDL Cholesterol|LDL Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
1464932|NCT00741026|Secondary|Triglycerides|Triglycerides|3 Days||||mg/dl||Standard Deviation|Mean
1464933|NCT00741026|Secondary|HDL Cholesterol|HDL Cholesterol|3 Days||||mg/dl||Standard Deviation|Mean
1464897|NCT00741390|Primary|Difference in Lancing Pain for Device Pair at Visit 2. (For Subjects Assigned to Arms A, B, C Only)|In Visit 2 subjects kept the same group assignment they had in Visit 1. Each subject tested 2 of the 3 systems from Visit 1. Up to 6 pairs of lancings were performed in order to obtain 4 evaluable pairs. After each pair of lancing, the subject was asked to record the pain from the 2nd lancing as compared to the first using a 150mm visual analog scale(0mm = same pain, -75mm = max score for less painful than first lancing,+75mm = max score for more painful). A positive value on the scale (and in table below) indicates that the first device in the pair was more painful than the second.|Approximately Day 3 (Visit 2)|Of the 234 subjects that completed Visit 2, 229 had evaluable pairs and were included in the analysis for Visit 2. Some of the lancing pairs from several subjects were excluded due to protocol deviations, subject discontinuation or adverse events. Of these 175 subjects were analyzed for this primary outcome.|||mm||Standard Deviation|Mean
1464898|NCT00741390|Primary|Blood Sample of Sufficient Volume to Yield a Valid Meter Reading|Number of subjects in whom valid meter reading was obtained with each device configuration. The primary outcome of a successful lancing is defined as whether or not a technician is able to use the lancing system to yield a blood sample of sufficient volume to yield a valid meter reading.|Study Day 1 (Visit 1)|BD/BD33g and Mini/BD33g were included in 4 arms,the Mini/OT28g in 2 arms,and Ultra/OT28g and AC/AC28g in 1 arm. Thus the # of subj evaluated for each device was 246, 246, 124, 63, and 60, resp. Subj were analyzed for blood volume adequacy if they completed the depth setting/volume testing for at least 1 device w/o significant protocol deviation.|||Participants|||Number
1464899|NCT00741338|Secondary|Percent Reduction of Urinary Glycosaminoglycan (uGAG) Level From Baseline to the End of Treatment/Early Withdrawal|Urinary Glycosaminoglycan (uGAG) Levels: concentration of glycosaminoglycan (GAG) relative to creatinine in urine. A greater decrease in uGAG level indicates a greater response.|Baseline, end of treatment/early withdrawal (up to 24 weeks after start of full-dose laronidase therapy)|Safety population included all participants who received any study drug treatment.|||percent change in uGAG level||Full Range|Median
1464900|NCT00741338|Primary|Number of Participants Who Achieved Immune Tolerance Induction|Immune tolerance induction success was defined as development of an anti-laronidase immunoglobulin G (IgG) antibody titer less than or equal to (<=) 1:3200 after 24 weeks of receiving full-dose (0.58 mg/kg) laronidase therapy.|24 weeks after start of full-dose laronidase therapy|Safety population included all participants who received any study drug treatment.|||participants|||Number
1464901|NCT00741286|Secondary|Number of Patients With First Recurrent Stroke of Any Type||90 days||||participants|||Number
1464902|NCT00741286|Primary|The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study|The PI is designed to measure vascular resistance and characterizes the shape of the spectral waveform. For the study, the mean, systolic, and diastolic flow velocities were measured using TCD. Gosling’s PI was determined as the difference between the peak systolic and end-diastolic velocities divided by the mean flow velocity in each artery.The changes of MCA and BA PIs at 14 and 90 days from the baseline TCD study was calculated for the study.|14 days and 90 days from the baseline TCD study|Of the 203 patients included in the intention-to-treat analysis, 164 were included in the per-protocol analysis of the primary outcome.|||ratio||Standard Deviation|Mean
1464903|NCT00741273|Primary|Proellex Half-life (T1/2)|Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours||||Hours||Standard Deviation|Mean
1464904|NCT00741273|Secondary|Area Under the Curve (AUC0-t) for Proellex|AUC0-t of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose.|48 hours||||ng x min/L||Standard Deviation|Mean
1464905|NCT00741273|Primary|Maximum Blood Concentration (Cmax)|Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..|48 hours||||ng/L||Standard Deviation|Mean
1464906|NCT00741260|Secondary|Duration of Response|Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|From start date of response to first PD/death, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||weeks||95% Confidence Interval|Median
1464907|NCT00741260|Secondary|Clinical Benefit Rate|The percentage of subjects with Complete Response, Partial Response, or Stable Disease at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From first dose date to progression or last tumor assessment, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||percentage of participants||95% Confidence Interval|Number
1464934|NCT00741026|Primary|Plasma Free Fatty Acid|Plasma Free Fatty Acid|3 Days||||mM||Standard Deviation|Mean
1464935|NCT00741026|Primary|Oral Glucose Tolerance|Oral Glucose Tolerance|3 Days||||min*mg/dl||Standard Deviation|Mean
1464936|NCT00741026|Primary|Plasma Leptin|Leptin following placebo or olanzapine treatment|3 Days||||ng/ml||Standard Deviation|Mean
1507946|NCT00413634|Primary|Time of Maximum Plasma Concentration (Tmax) of Agrylin||over 1 day|PK population|||hours||Standard Deviation|Geometric Mean
1464908|NCT00741260|Secondary|Overall Response Rate|Number of Subjects with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to three years.|Evaluable Population includes subjects who met all inclusion/exclusion criteria, received at least two weeks of neratinib and capecitabine, and underwent valid tumor assessments at baseline and at least one post-baseline time point stratified by prior Lapatinib exposure.|||percentage of participants||95% Confidence Interval|Number
1464909|NCT00741260|Primary|Number of Participants With Dose Limiting Toxicities|"Number of participants reporting Adverse Events Causing Dose Limiting Toxicities (DLT).~Maximum Tolerated Dose (MTD) reflects the highest dose of Neratinib that did not cause a selected Grade 3 toxicity in >= 2 participants."|From first dose date to 21st day or to time receiving 75% of planned doses|Safety population|||Participants|||Count of Participants
1464910|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat|Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat|Baseline and after enalaprilat||||Wood units per metre squared||Full Range|Median
1464911|NCT00741156|Primary|Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat||Baseline and after enalaprilat||||l/min/m2||Inter-Quartile Range|Median
1464912|NCT00741104|Primary|Number of Patients Agreeing to Participate in a Dose Reduction Study|"As part of the Remicade questionnaire, patients were asked would you consider participating in a dose reduction study?"|Measured from the Remicade Questionnaire at first (and only) study visit|Out of the 363 subjects in the analysis, 361 subjects answered this question.|||participants|||Number
1464913|NCT00741104|Primary|Patient Response to Increased Dosing Interval|"Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked did you notice any difference when your dosing interval was extended? Those who noticed a difference were asked if their experience was positive or negative."|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.|||participants|||Number
1464914|NCT00741104|Primary|Reason for Extending Dosing Interval|Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.|Measured from the Remicade Questionnaire at first (and only) study visit|Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.|||participants|||Number
1464915|NCT00741104|Secondary|Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
1464916|NCT00741104|Secondary|Adverse Events (AEs)|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
1464917|NCT00741104|Secondary|Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.|This is not a prespecified key secondary outcome; therefore, results will not be disclosed|Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.|||||||
1464918|NCT00741104|Primary|Dosing Interval Between the Infliximab Infusions|Patients were asked as part of the Remicade questionnaire what dosing interval they were on.|Measured from the Remicade Questionnaire at first (and only) study visit||||participants|||Number
1464919|NCT00741091|Secondary|Device Malfunction|Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.|30 days||||Devices|||Number
1464920|NCT00741091|Secondary|System Technical Success|System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.|30 days|To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.|||Participants|||Number
1464921|NCT00741091|Secondary|Target Lesion Revascularization|Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.|30 days||||Participants|||Number
1464922|NCT00741091|Secondary|Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)|Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.|30 days||||Participants|||Number
1464923|NCT00741091|Primary|Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)|Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).|30 days|All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.|||Participants|||Number
1464937|NCT00741013|Secondary|Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation|Number of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data.|24 hours after endotoxin instillation||||cells per cubic mm||Standard Deviation|Mean
1464938|NCT00741013|Primary|Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation|Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment|24 hours after endotoxin instillation||||Change in Ki||Standard Deviation|Mean
1464939|NCT00740870|Secondary|Functional Assessment (NYHA Classification)|Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.|6 Months|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours and had paired data from pre-implant to 6 months post-implant.|||Participants|||Count of Participants
1464940|NCT00740870|Secondary|Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)|Deaths (all-cause, procedural and device-related) at 5 years|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of subjects||95% Confidence Interval|Number
1464941|NCT00740870|Secondary|Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit|Freedom From Surgical Replacement of the RVOT Conduit|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1464942|NCT00740870|Secondary|Kaplan-Meier Freedom From Catheter Re-intervention on TPV|All Catheter Re-intervention on TPV at 5 years|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1464943|NCT00740870|Secondary|Kaplan-Meier Freedom From Major Stent Fracture at 5 Years|Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1464944|NCT00740870|Secondary|Serious Device-related Adverse Event|A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).|5 years|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.|||percentage of subjects|||Number
1464945|NCT00740870|Secondary|Serious Procedural Adverse Event (AE)|A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).|5 years|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.|||percentage of subjects|||Number
1464946|NCT00740870|Secondary|Procedural Success|"Procedural success is a composite outcome defined as:~Melody TPV fixated within the desired location~Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant~Less than mild pulmonary regurgitation by angiography post-implant~Free of explant at 24 hours post-implant"|Within 24 Hours post implant|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).|||percentage of subjects|||Number
1464947|NCT00740870|Primary|Kaplan-Meier Freedom From TPV Dysfunction|"To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following:~Hemodynamic dysfunction of the TPV~Moderate or greater pulmonary regurgitation, and/or~Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg~RVOT reoperation for conduit dysfunction or device-related reasons~Catheter re-intervention on the TPV"|5 years|The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.|||percentage of subjects||95% Confidence Interval|Number
1464948|NCT00740857|Secondary|Time to First Perceptible Relief|The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.|||minutes||95% Confidence Interval|Median
1464949|NCT00740857|Secondary|Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours|TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1464950|NCT00740857|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours|SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1464982|NCT00740714|Secondary|Adverse Experiences: Constipation|Number of participants with constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464951|NCT00740857|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points|PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1464952|NCT00740857|Secondary|Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours|SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).|0-2 and 0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1464953|NCT00740857|Secondary|Pain Relief (PR) Scores at Individual Time Points|"Response to the question How much pain do you have from your starting pain? was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken."|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1464954|NCT00740857|Secondary|Pain Intensity Difference (PID) Scores at Each Individual Time Points|PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).|||units on scale||Standard Deviation|Mean
1464955|NCT00740857|Primary|Time to Meaningful Pain Relief|Subjects evaluated the time to “First Perceptible” Relief by depressing a stopwatch at the moment they first began to experience “perceptible” relief and the time to “Meaningful” Relief by depressing a second stopwatch at the moment they first began to experience “meaningful” relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.|0-6 hours|All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.|||minutes||95% Confidence Interval|Median
1464956|NCT00740831|Primary|Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist|"Difference in percentage of subjects reporting moderate or severe hot flushes:~Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17."|Up to week 17|Safety population|||percentage of patients|||Number
1464957|NCT00740831|Primary|Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist|Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples|Week 13 visit|Safety population|||log 10 (log pg/ml) E2||Standard Error|Mean
1464958|NCT00740831|Secondary|Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13|"Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.~The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10)."|3 months|Per protocol|||Log 10 (Log cm3) Total volume||Standard Error|Mean
1464959|NCT00740831|Primary|Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit)|"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment."|3 months|Per protocol|||percentage of patients|||Number
1464960|NCT00740792|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement.|day 1 to day 14|Intent to Treat (ITT) population (18 yrs of age and older) who have had one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
1464961|NCT00740792|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)|"change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative value is suggestive of improvement."|day 1 to14|Intent to Treat (ITT)population includes all subjects who were randomized and had at least one post baseline efficacy observation.|||units on a scale||Standard Deviation|Least Squares Mean
1464983|NCT00740714|Secondary|Adverse Experiences: Back Pain|Number of participants with back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464962|NCT00740792|Primary|Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS)|"change from baseline in 12-hour reflective(how you felt over the previous 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.~The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improvement."|day1 to 14 days|Intent-to-Treat(ITT) population includes all subjects who were randomized and had at least one post baseline efficacy observation|||units on a scale||Standard Deviation|Least Squares Mean
1464963|NCT00740779|Primary|National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.|Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.|12 weeks|The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).|||Units on a 0 to 43 scale||Standard Deviation|Mean
1464964|NCT00740727|Secondary|Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up|"Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.~Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back)."|2 days|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1464965|NCT00740727|Secondary|Number of Participants With Pain During EASI Infusion|Assessment during EASI placement & initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1464966|NCT00740727|Primary|Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose|Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1464967|NCT00740727|Primary|Number of Participants With Successfully Placed EASI Lines|"Ability of Basic Life Support (BLS) providers to place EASI access lines.~The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed)."|1 day|Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.|||Participants|||Number
1464968|NCT00740714|Secondary|Adverse Experiences: Insomnia: Moderate/Severe|Number of participants with moderate/severe insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464969|NCT00740714|Secondary|Adverse Experiences: Back Pain: Moderate/Severe|Number of participants with moderate/severe back pain|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464970|NCT00740714|Secondary|Adverse Experiences: Anxiety: Moderate/Severe|Number of participants with moderate/severe anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464971|NCT00740714|Secondary|Adverse Experiences: Constipation: Moderate/Severe|Number of participants with moderate/severe constipation|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464972|NCT00740714|Secondary|Adverse Experiences: Depression|Number of participants with depression|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464973|NCT00740714|Secondary|Adverse Experiences: Hypertension|Number of participants with hypertension|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464974|NCT00740714|Secondary|Adverse Experiences: Nausea|Number of participants with nausea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464975|NCT00740714|Secondary|Adverse Experiences: Urinary Tract Infection|Number of patients with urinary tract infections|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464976|NCT00740714|Secondary|Adverse Experiences: Headache|Number of participants with headache|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464977|NCT00740714|Secondary|Adverse Experiences: Diarrhoea|Number of participants with diarrhoea|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464978|NCT00740714|Secondary|Adverse Experiences: Nasopharyngitis|Number of participants with nasopharyngitis|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464979|NCT00740714|Secondary|Adverse Experiences: Tremor|Number of participants with tremor|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464980|NCT00740714|Secondary|Adverse Experiences: Anxiety|Number of participants with anxiety|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464981|NCT00740714|Secondary|Adverse Experiences: Insomnia|Number of participants with insomnia|Over 16 months (Screening, Baseline, 1, 4, 8, 12 and 16 month visits)|All participants were used in primary and secondary outcome analysis.|||participants|||Number
1464984|NCT00740714|Secondary|CoQ10 Levels in Plasma|Based on samples analyzed to date|Baseline, 1, 8 and 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants have been included and data is based on samples analyzed to date.|||ug/ml||Standard Deviation|Mean
1464985|NCT00740714|Secondary|Change in Hoehn & Yahr Score From Baseline to 16 Months|The Modified Hoehn and Yahr Scale is an 8-level Parkinson disease staging instrument. The investigator will assess disease stage at each level. The disease stages range from the best outcome of 0 (no signs of disease) to the worst outcome of 5 (wheelchair bound or bedridden unless aided).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1464986|NCT00740714|Secondary|Change in Symbol Digit Modalities Test From Baseline to 16 Months|The Symbol Digit Modalities Test screens cognitive impairment by using a simple substitution tasks that individuals with normal functioning can easily perform. The test score range is from 0(worst outcome) to 110 (best outcome).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1464987|NCT00740714|Secondary|Change in PD Quality of Life Scale From Baseline to 16 Months|The subject will complete a questionnaire that will evaluate how Parkinson disease has affected their health and overall quality of life at each visit. The total quality of life scale measures a total of 33 aspects of quality of life. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). Total score range is 0-132. A higher score or increased score compared to a previous visit indicates a lowered quality of life.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1464988|NCT00740714|Secondary|Change in Modified Rankin Scale From Baseline to 16 Months|The Modified Rankin Scale is a global functional health index with a strong accent on physical disability. Subjects are scored on a scale of 0 (no symptoms at all) to 5 (severe disability: bedridden incontinent, and requiring constant nursing care and attention.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1464989|NCT00740714|Secondary|Change in Modified Schwab & England Independence Scale From Baseline to 16 Months|This scale measures activities of daily living. This is an investigator and subject assessment of the subject's level of independence at all scheduled visits. The subject is scored on a percentage scale reflective of his/her ability to perform acts of daily living in relation to pre-Parkinson disease ability. Scores range in increments of 10%: 100% for normal (subject is completely independent; essentially normal) to 0% (vegetative functions such as swallowing, bladder and bowel functions are not functioning; bedridden).|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|All participants were used in primary and secondary outcome analyses.|||units on a scale||Standard Error|Least Squares Mean
1464990|NCT00740714|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Total Score (Sum of Parts I, II and III Ranges From 0 to 176))|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline visit and month 16 or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. The UPDRS score has three components, each consisting of questions answered on a 0-4 point scale. Part I assesses mentation, behavior and mood; Part II assesses activities of daily living in the week prior to the designated visit; and Part III assesses motor abilities at the time of the visit. A total of 31 items are included in Parts I, II and III. Each item will receive a score ranging from 0 to 4 where 0 represents the absence of impairment and 4 represents the highest degree of impairment. Total score ranges from 0-176.|Baseline to 16 months or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first|Eligible research participants were assigned by randomization to one of three treatment groups: CoQ10 2400 mg/day, CoQ10 1200 mg/day or matching placebo. All participants also received 1200 IU of vitamin E daily.|||units on a scale||Standard Error|Least Squares Mean
1464991|NCT00740636|Primary|The Objective Overall Response|"The objective response is defined as all complete responses and partial responses based on the modified RECIST.Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|2 years||||participants|||Number
1464992|NCT00740597|Primary|Wound Complication Rate|"Major wound complications up to 4 months post surgery include:~Complications requiring a secondary operation under general or regional anesthesia for wound care.~Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days."|1 year|The one patient accrued to the study stopped treatment prior to completing treatment due to insurance denial.||||||
1464993|NCT00740584|Secondary|Incidence of Adverse Experiences||Approximately 13 weeks|||||||
1464994|NCT00740584|Primary|HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)|"The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture.~The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has."|at 3 hours||||percent anti-viral activity||Inter-Quartile Range|Median
1465024|NCT00739999|Secondary|Absolute Change From Baseline in Total Cholesterol (TC)|Total Cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1464995|NCT00740480|Secondary|Tissue Reaction to Implant|None - no edema, erythema or purulence around the area of the staples Mild - slight erythema and/or edema in the region of one or more staple, limited to not greater than 2 mm from the staple Moderate - erythema and/or edema in the region of one or more staples, greater than 2 mm extension from the staples Severe - Generalized edema and/or erythema of the septum, or purulence and/or granulation tissue involved in one or more staples.|One week post surgery|ITT|||participants|||Number
1464996|NCT00740480|Primary|Coaptation (Tissue Approximation)|Complete tissue approximation at one week.|One week post surgery|ITT|||participants|||Number
1464997|NCT00740220|Primary|Kappa Statistic for Correlation of the Oxygen Saturation Across 3 Serial 6 Minute Walk Tests (6MWT)|The kappa statistic is a measure of the quality of a test. It is a ratio.|All three 6MWTs should take place within 30 days||||Ratio|||Number
1464998|NCT00740207|Secondary|The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.|Immediately postdose||||Participants|||Number
1464999|NCT00740207|Secondary|The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.|Immediately postdose|Patients who did not deviate from the planned protocol.|||Participants|||Number
1465000|NCT00740207|Primary|Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.|Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.|Immediately prior to power injection run and again immediately following power injection run|Patients who did not deviate from the planned protocol.|||Participants|||Number
1465001|NCT00740181|Primary|Response Rate|"Complete Response/Complete Remission:~Complete remission (CR) is defined as the presence of all of the following:~Peripheral blood - No leukemic blasts present.~No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)~Bone marrow~No Auer rods~Less than 5% blast cells.~CBC and bone marrow criteria must be met within one week of each other.~Hemoglobin 9g/dl or greater~Neutrophil count >1000 and platelet count >100,000.~RBC Transfusion free for 2 weeks."|within 30 days of last treatment||||participants|||Number
1465002|NCT00740051|Secondary|The Change in FPG From Baseline by Visit Over Time|This change from baseline reflects the FPG (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 FPG.|Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)|||mg/dL||Standard Deviation|Mean
1465003|NCT00740051|Secondary|The Change in HbA1c From Baseline by Visit Over Time|HbA1c is measured as a percentage. Thus, this change from baseline reflects the HbA1c percent (at weeks 6, 12, 18, 22, 26, 30, 34, 40, 46, 52) minus the Week 0 HbA1c percent.|Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52|Treated set (OC)|||percent||Standard Deviation|Mean
1465004|NCT00740051|Secondary|Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Patients without a value at week 18 were analysed as non-responders.|||percent of patients|||Number
1465005|NCT00740051|Secondary|Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|FAS patients with baseline HbA1c >= 6.5%. Patients without a value at Week 18 were analysed as non-responders.|||percent of patients|||Number
1465006|NCT00740051|Secondary|Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)|Odds ratios are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Week 18|Full Analysis Set (FAS) patients with baseline HbA1c >= 7.0%. Patients without a value at week 18 were analysed as non-responders.|||percent of patients|||Number
1465007|NCT00740051|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. Means are adjusted for baseline FPG, baseline HbA1c, prior OADs and reason for metformin intolerance (Interim Analysis).|Baseline and week 18|All patients in FAS with values for FPG at baseline and at week 18. Last Observation Carried Forward (LOCF) was used as the imputation rule (Interim Analysis).|||mg/dl||Standard Error|Mean
1465008|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Final Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
1465009|NCT00740051|Primary|HbA1c Change From Baseline at Week 18 (Interim Analysis)|HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.|Baseline and week 18|The Full Analysis Set (FAS) included all treated patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last Observation Carried Forward (LOCF) was used as the imputation rule.|||percent||Standard Error|Mean
1465145|NCT00738894|Secondary|Number of Subjects With Study-related Serious Adverse Events|Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site|24 months|Intention to Treat: all subjects randomized|||Participants|||Count of Participants
1465010|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)|Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromatography tandem mass spectrometric method. Vc/F value based on 70 kg body weight. Parameter estimation uncertainty (95% CI) by non-parametric bootstrap analysis. Data presented are result of model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.|||liters||95% Confidence Interval|Number
1465011|NCT00739999|Secondary|Percent Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial Flow-Mediated Dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.|||percent change in FMD||Standard Deviation|Mean
1465012|NCT00739999|Secondary|Absolute Change From Baseline in Flow-Mediated Dilatation at Week 8|Brachial artery flow-mediated dilatation (FMD) = (max minus baseline diameter divided by baseline diameter) x 100%. Standardized image acquisition: brachial artery images recorded for one minute at rest, blood pressure cuff inflated to 250 mm Hg for 5 minutes with brachial artery imaged continuously throughout cuff inflation, cuff released to produce reactive hyperaemia and the brachial artery imaged continuously for 3 minutes after release. Total duration of measurement approximately 25 minutes. Change from baseline = value at observation minus baseline value.|Baseline, Week 8|PD analysis population. Flow-mediated dilation (FMD) was measured at centers with established FMD facilities.|||FMD||Standard Deviation|Mean
1465013|NCT00739999|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Very low-density lipoprotein-cholesterol (VLDL-C): percent (%) change from baseline by treatment over time = [VLDL-C at observation minus VLDL-C at Week 0] divided by VLDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in VLDL-C||Standard Deviation|Mean
1465014|NCT00739999|Secondary|Absolute Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C)|Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) measured in millimoles per liter (mmol/L). Change from baseline = value at observation minus baseline value. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1465015|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B)|Apolipoprotein B (Apo B): percent (%) change from baseline by treatment over time = [Apo B at observation minus Apo B at Week 0] divided by Apo B at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in Apo B||Standard Deviation|Mean
1465016|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein B (Apo B)|Change from baseline in Apolipoprotein B measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||g/L||Standard Deviation|Mean
1465017|NCT00739999|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Apolipoprotein A-1 (Apo A-1): percent (%) change from baseline by treatment over time = [Apo A-1 at observation minus Apo A-1 at Week 0] divided by Apo A-1 at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in Apo A-1||Standard Deviation|Mean
1465018|NCT00739999|Secondary|Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1)|Change from baseline in Apolipoprotein A-1 measured in grams per liter (g/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||g/L||Standard Deviation|Mean
1465019|NCT00739999|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|High-density lipoprotein cholesterol (HDL-C): percent (%) change by treatment over time = [HDL-C at observation minus HDL-C at Week 0] divided by HDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in HDL-C||Standard Deviation|Mean
1465020|NCT00739999|Secondary|Absolute Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|Change from baseline in high-density lipoprotein cholesterol measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1465021|NCT00739999|Secondary|Percent Change From Baseline in Triglycerides (TG)|Triglycerides (TG): percent (%) change from baseline by treatment over time = [TG at observation minus TG at Week 0] divided by TG at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in TG||Standard Deviation|Mean
1465022|NCT00739999|Secondary|Absolute Change From Baseline in Triglycerides (TG)|Change from baseline in triglycerides measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||mmol/L||Standard Deviation|Mean
1465023|NCT00739999|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Total cholesterol (TC): percent (%) change from baseline by treatment over time = [TC at observation minus TC at Week 0] divided by TC at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in TC||Standard Deviation|Mean
1465025|NCT00739999|Secondary|Percent Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density Lipoprotein Cholesterol (LDL-C): percent (%) change from baseline by treatment over time = [LDL-C at observation minus LDL-C at Week 0] divided by LDL-C at Week 0 * 100. Assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]).|Baseline, Week 2, Week 4, Week 6, Week 8|PD analysis population|||percent change in LDL-C||Standard Deviation|Mean
1465026|NCT00739999|Secondary|Absolute Change From Baseline in Pharmacodynamic Responses of Low-density Lipoprotein Cholesterol (LDL-C)|Low-density lipoprotein cholesterol (LDL-C) measured in millimoles per liter (mmol/L); assessments were performed in the fasting state (minimum 10-hour fast [optional at Weeks 2 and 6]). Change from baseline = value at observation minus baseline value.|Baseline, Week 2, Week 4, Week 6, Week 8|Pharmacodynamic (PD) analysis population: all enrolled subjects who received ≥ 1 dose of study drug and had ≥ 1 PD parameter measurement.|||mmol/L||Standard Deviation|Mean
1465027|NCT00739999|Primary|Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)|Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensitive, and specific high-performance liquid chromatography tandem mass spectrometric method. Data presented are the result of the model used.|Week 2, Week 4, Week 6, Week 8|Pharmacokinetic (PK) concentration population: all enrolled and treated subjects who had ≥ 1 PK concentration assessed. Active hydroxyacid metabolite p-hydroxyatorvastatin was not included in the model as originally planned as > 80% of samples were below detectable level at the doses used in this trial.|||L/hr|||Number
1465028|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Systolic Blood Pressure Response|Blood pressure response in msSBP is defined as a mean sitting systolic blood pressure < 140 mmHg or a >= 20 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
1465029|NCT00739973|Secondary|Percentage of Patients Achieving a Successful Diastolic Blood Pressure Response|Blood pressure response in msDBP is defined as a mean sitting diastolic blood pressure < 90 mmHg or a >=10 mmHg reduction from baseline. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
1465030|NCT00739973|Secondary|Percentage of Patients With Blood Pressure Control (msSBP < 140 mm Hg and msDBP < 90 mm Hg) at End of Study|Blood pressure control defined as msSBP < 140 mm Hg and msDBP < 90 mm Hg. The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|End of study (Week 8)|All patients who were randomized. Following the intent-to-treat principle, patients will be analyzed according to the treatment they were assigned to at randomization. Patients with baseline and Endpoint msDBP values were included in this analysis.|||Percentage of Participants|||Number
1465031|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465032|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465196|NCT00738374|Secondary|Duration of Response|The mean time, in days, from the date of first documented CR, CRi or PR to the date disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||days||Standard Error|Mean
1465033|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465034|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465035|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465036|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465037|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465038|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All randomized patients who received the study medication.|||mm Hg||Standard Error|Least Squares Mean
1465039|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465070|NCT00739934|Primary|Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|Intent-to treat (ITT) population of participants who had completed pharmacokinetic (PK) blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1465040|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465041|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/10 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465042|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465043|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465044|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465045|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465046|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Amlodipine 10 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465221|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7). ."|14 days||||participants|||Number
1465047|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465048|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465049|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465050|NCT00739973|Primary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465051|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/10 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (mssBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465052|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Placebo on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465053|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465263|NCT00737672|Secondary|Procedural Success|Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.|Following Index Procedure||||Participants|||Number
1465264|NCT00737672|Secondary|Anatomic Success|Less than 30 percent residual stenosis following study treatment (Index Procedure).|Index Procedure||||Participants|||Number
1465054|NCT00739973|Secondary|Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP)|The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements.|Baseline to end of study (Week 8)|Full Analysis Set (FAS): All participants who were randomized. Participants mis-randomized were excluded from the FAS. Mis-randomized participants refer to participants who were not qualified for randomization but were inadvertently randomized into the study. These participants did not receive study drug.|||mm Hg||Standard Error|Least Squares Mean
1465055|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1465056|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1465057|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1465058|NCT00739934|Secondary|Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N=number of participants with analyzable data.|||hours||Full Range|Median
1465059|NCT00739934|Secondary|Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1465060|NCT00739934|Secondary|AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1465061|NCT00739934|Secondary|Trough Concentrations (Cmin)||Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data; n = number of participants who contributed to data.|||μg/mL||Standard Deviation|Geometric Mean
1465062|NCT00739934|Secondary|Tmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1465063|NCT00739934|Secondary|Cmax Following an IV Loading Dose||Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1465064|NCT00739934|Secondary|AUC12 Following IV Loading Dose|AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.|Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1465065|NCT00739934|Primary|Tmax Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1465066|NCT00739934|Primary|Cmax,ss Following Oral Administration||Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1465067|NCT00739934|Primary|AUC12,ss Following Oral Administration|AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg*h/mL||Standard Deviation|Geometric Mean
1465068|NCT00739934|Primary|Time to Reach Cmax (Tmax) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||hours||Full Range|Median
1465069|NCT00739934|Primary|Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose|ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.|||μg/mL||Standard Deviation|Geometric Mean
1465265|NCT00737672|Secondary|Clinical Success|The resumption of normal dialysis for at least one session following study treatment (Index Procedure).|Following Index Procedure||||Participants|||Number
1507947|NCT00413634|Secondary|Heart Rate|Heart rates in patients with ET receiving Agrylin|over 1 day|Safety population|||beats/min||Standard Deviation|Mean
1465071|NCT00739908|Secondary|Clinical Global Impression - Severity of Illness (CGI-S)|CGI-S measures the study rater's assessment of the severity of depression illness. CGI-S is rated on a scale of 1-7 as follows: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill patients. CGI-S was measured at randomization and Weeks 1, 2, 4 and 6. Percentage of subjects reported as normal, not at all ill; borderline mentally ill; and mildly ill is reported here at Week 6 or the last available post treatment result (LOCF).|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants|||Number
1465072|NCT00739908|Secondary|Clinical Global Impression - Improvement of Illness (CGI-I)|"The Clinical Global Impression - Improvement of Illness (CGI-I) was rated on a 7-point scale by the investigator to measure subject’s total improvement compared to his/her condition at randomization according to the following scale: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I was measured at Weeks 1, 2, 4 and 6. Percentage of participants very much improved and much improved at Week 6 or the last available post treatment result (LOCF) is reported here."|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants|||Number
1465073|NCT00739908|Secondary|Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)|IDSR-SR 30 measures the severity of depressive symptoms by subjects. This scale has 30 items. The minimum score is 0 and the maximum possible IDS-30 score is 90 (the highest severity). IDS-SR30 was administered at screening, randomization and Weeks 1, 2, 4, and 6. Change from randomization in the IDS-SR30 total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||units on a scale||95% Confidence Interval|Least Squares Mean
1465074|NCT00739908|Secondary|The Hospital Anxiety and Depression Scale (HADS)|HADS is a subject-rated questionnaire designed to detect states of anxiety and depression. The HADS consists of 14 questions relating to anxiety or depression, each with a choice of four responses [Zigmond, 1983]. These responses are numerically scored 0-3, with 0 representing the least severe response and 3 representing the most severe response. The highest possible total score is 42. HADS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. Change from randomization in the HADS total score at Week 6 or the last available post treatment result (LOCF) is reported here.|Randomization and Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||units on a scale||95% Confidence Interval|Least Squares Mean
1465075|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate|Percentage of participants with total MADRS score of 11 or less. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Remitter rate at Week 6 or the last available post treatment result (LOCF)is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomzation MADRS score.|||Percentage of Participants||95% Confidence Interval|Number
1465076|NCT00739908|Secondary|Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate|MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. Percentage of participants who achieved a reduction in total MADRS score of at least 50% or more as compared to baseline. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Responder rate at Week 6 or the last available post treatment result (LOCF) is reported here.|Week 6 or the last available post treatment result (LOCF)|mITT population consisted of all patients with at least one post randomization MADRS score.|||percentage of participants||95% Confidence Interval|Number
1465077|NCT00739908|Primary|Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.|Randomization and study end (Week 6).|mITT population consisted of all patients with at least one post randomzation MADRS score. The primary efficacy variable was the change-from-randomization to each available post-randomization measurement of the MADRS total score, used as the response variable in a mixed model repeated measures (MMRM) analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
1465078|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1465079|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment (PGA) Rating of Good, Excellent, Or Cleared At Week 12|"The proportion of participants achieving a PGA rating of good, excellent, or cleared at Week 12.~Cleared = 100% improvement; Excellent = 75-99% improvement; Good = 50-74% improvement"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1465080|NCT00739882|Secondary|Proportion of Participants From the Initial Placebo Group Achieving a PGA – H&F of Rating of Clear, Almost Clear, or Mild From Week 12 to Week 24.|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1465097|NCT00739674|Primary|Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||Participants|||Number
1465081|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Almost Clear Or Mild At Week 24|"The proportion of participants achieving a PGA - H&F rating of clear, almost clear, or mild at Week 24:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|24 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1465082|NCT00739882|Secondary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA - H&F) Rating Of Clear, Or Almost Clear At Week 12|"The proportion of participants achieving a PGA – H&F rating of clear, or almost clear, at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1465083|NCT00739882|Primary|Proportion Of Participants Achieving A Physician's Global Assessment - Hand & Foot (PGA – H&F) Rating Of Clear, Almost Clear Or Mild At Week 12|"The proportion of subjects achieving a PGA – H&F rating of clear, almost clear, or mild at Week 12:~Clear - No signs of plaque psoriasis on the hands and/or feet; Almost Clear - Just perceptible erythema and just perceptible scaling on the hands and/or feet; Mild - Light pink erythema with minimal scaling and with or without pustules on the hands and/or feet"|12 weeks|Due to the termination of the trial, analysis of efficacy-related endpoints was not performed||||||
1465084|NCT00739765|Secondary|Hamilton Depression Rating Scale|Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores <8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62|After 14 weeks of treatment||||units on a scale||Standard Deviation|Mean
1465085|NCT00739765|Primary|Clinician-Administered PTSD Scale (CAPS)|Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores >50 indicate at least moderately severe PTSD; scores <20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75–90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156|After 14 weeks of treatment||||units on a scale||Standard Deviation|Mean
1465086|NCT00739752|Primary|Number of Participants Administered Hepatitis B Vaccine|Number of participants administered hepatitis B vaccine on the day of research visit.|Day of research visit||||Participants|||Count of Participants
1465087|NCT00739674|Secondary|Time to Achieve the Target Blood Pressure From Baseline|Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).|14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 437 and 386 patients for L group and DML group respectively.|||Weeks||95% Confidence Interval|Median
1465088|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1465089|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 10||10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1465090|NCT00739674|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1465091|NCT00739674|Secondary|Change in Systolic Blood Pressure From Baseline to Week 6||6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1465092|NCT00739674|Primary|Change in Diastolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1465093|NCT00739674|Primary|Change in Systolic Blood Pressure From Baseline to Week 14||14 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 357 patients at week 14 for L group and DML group respectively.|||mm Hg||Standard Deviation|Mean
1465094|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment|40 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively.|||Participants|||Number
1465095|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment|10 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively.|||Participants|||Number
1465096|NCT00739674|Secondary|Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline|Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment|6 Weeks|463 and 400 – number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively.|||Participants|||Number
1465099|NCT00739661|Secondary|Progression-free Survival (PFS) in Patients With Versus Without Hedgehog Antigen Tumor Expression|Hedgehog antigen expression was measured with immunohistochemical methods in tumor tissue taken from each patient prior to enrollment in the study. The percentage of cells with (> 0%) and without (0%) Hedgehog antigen expression was measured microscopically. PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients. Tissue for evaluation was only available for 29 patients in the vismodegib group and 28 patients in the placebo group.|||Months||95% Confidence Interval|Median
1465100|NCT00739661|Primary|Progression-free Survival (PFS)|PFS was defined as the time between randomization and disease progression, as confirmed by radiography, or death for any reason. Since patients were in remission at the start of the study, they had no evidence of the presence of tumors. Disease progression was defined as radiographic evidence of a tumor. Tumor assessments by computed tomography (CT) of the chest, abdomen, and pelvis were performed at screening and every 8 weeks during the study.|From randomization date through the data cut-off date of May 15, 2010, up to 100 weeks|Intent-to-treat patient population: All randomized patients.|||Months||95% Confidence Interval|Median
1465101|NCT00739648|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1)|The percent change in the amount of air a patient can exhale in 1 second|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT|||Percent||Standard Error|Least Squares Mean
1465102|NCT00739648|Secondary|Percent Change in Forced Vital Capacity (FVC)|The percent change in the amount of air a patient can inhale|from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)|MITT|||Percent||Standard Error|Least Squares Mean
1465103|NCT00739648|Secondary|Duration of Acute Exacerbation|From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation|from randomization to the patient's final study visit (up to 12 months)|MITT|||Days||Standard Deviation|Mean
1465104|NCT00739648|Primary|Exacerbation Rate|The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.|From randomization to the patients final study visit (up to 12 months)|modified intent to treat (MITT; patients who received at least one dose of study drug)|||exacerbation per patient year||Standard Error|Mean
1465105|NCT00739596|Secondary|Percentage of Participants Achieving BP Control After 8 Weeks of Treatment|To compare the percentage of patients achieving BP control (<140/90 mm Hg) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.|||Cumulative percentage of participants|||Number
1465106|NCT00739596|Secondary|Percentage of Responders After 8 Weeks of Treatment.|To compare the percentage of responders after 8 weeks of treatment with an aliskiren HCTZ based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension: [ Responders were defined as patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg at 1st response. A response was counted when a patient first achieved MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg.]|8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable.|||Cumulative percentage of responders|||Number
1465107|NCT00739596|Secondary|Change in Mean Sitting Pulse Pressure (MSPP) After 8 Weeks of Treatment|To compare the change from baseline in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
1465108|NCT00739596|Secondary|Change in Mean Sitting Diastolic Blood Pressure (MSDBP) After 8 Weeks of Treatment|To assess the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
1465109|NCT00739596|Primary|Change in Mean Sitting Systolic Blood Pressure (MSSBP) After 8 Weeks of Treatment|To assess the change from baseline in MSSBP after 8 weeks of treatment with an aliskiren HCTZ-based treatment regimen (aliskiren HCTZ 150/12.5 mg, 300/25 mg) versus an amlodipine-based treatment regimen (amlodipine 5 mg, 10 mg) in African American patients with stage 2 hypertension.|Baseline and 8 weeks|The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study medication and had at least one valid post-baseline assessment of the primary efficacy variable. Last observation carried forward (LOCF) method was used for replacing missing values with post-baseline assessments.|||mm Hg||Standard Deviation|Mean
1465197|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR, CRi, or PR|Duration of response was defined as the time from the date of the first documented CR, CRi, or PR to the date of disease progression or death. CR, CRi, PR, and PD as previously defined. Participants with no documented PD after CR, CRi, or PR were censored at the last date at which they were known to have had CR, CRi, or PR, respectively.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||participants|||Number
1465110|NCT00739583|Secondary|Judgment of Reviewing Orthopaedic Surgeons That the Site Marking is Identifiable for Them to Perform Site Identification|The number of sets of initials judged by the viewing orthopedic surgeons as sufficient for adequate site identification. Each participant was labeled with three initials to simulate a surgeon's initials. Ten orthopaedic surgeons determined if the initials were visible enough to allow for site identification. Each surgeon viewed all of the sets of initials, resulting in 100 viewed sets of initials in each group.|at time of surgery, approximately ten minutes||||sets of intials|Participants||Number
1465111|NCT00739583|Secondary|The Mean Change in Gray Level (Contrast) of the Horizontal Line|The Mean change in gray level of the ink line as expressed in units between pre and post skin preparation. Gray level is a unitless value from 0-255 describing the brightness of a pixel (0 being black and 255 being white).|at time of surgery, approximately ten minutes||||gray level units|Participants|Standard Deviation|Mean
1465112|NCT00739583|Primary|Identification of the Random Initials by the Reviewing Orthopaedic Surgeons|The number of correctly identified initials as viewed by the orthopaedic surgeons. 10 participants were randomized to each study group. Each patient was marked with three initials. Each was viewed by ten surgeons giving a total of 300 initials for each group.|at time of surgery, approximately 10 minutes||||number of correctly identified initals|Participants||Number
1465113|NCT00739336|Secondary|Questionnaires||baseline, 3, 6, 12 months|||||||
1465114|NCT00739336|Secondary|Waist Circumference||baseline, 3, 6, 12 months|||||||
1465115|NCT00739336|Secondary|Hemoglobin A1c|hemoglobin A1c (%)|baseline||||percent||Standard Deviation|Mean
1465116|NCT00739336|Secondary|Fasting Lipid Profile|LDL-cholesterol (mg/dL)|Baseline||||mg/dL||Standard Deviation|Mean
1465117|NCT00739336|Secondary|Fasting Glucose Level|Fasting glucose (mg/dL)|Baseline||||mg/dL||Standard Deviation|Mean
1465118|NCT00739336|Primary|Body Weight|Weight loss in kg|3 months|"Participants from the wait-list Control Arm have been combined in the Intervention Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis."|||kg||95% Confidence Interval|Mean
1465119|NCT00739310|Primary|Hospitalizations Lasting at Least 24 Hours in This Patient Population|Hospitalizations lasting at least 24 hours|end of study||||hospitalizations|||Number
1465120|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.|0 (baseline) and 24 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
1465121|NCT00739297|Other Pre-specified|Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast|Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.|0 (baseline) and 8 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
1465122|NCT00739297|Secondary|Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration|FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (albuterol or matching placebo) 4 hours after treatment with montelukast at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L||95% Confidence Interval|Least Squares Mean
1465123|NCT00739297|Primary|Change From Baseline in FEV1 Over 4 Hours|FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.|0 (=baseline) to 4 hours after treatment with montelukast|Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.|||L (Liter)||95% Confidence Interval|Least Squares Mean
1465124|NCT00739102|Secondary|Major Adverse Events at 12-month Post Procedure|Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1465125|NCT00739102|Secondary|Rutherford / Becker Classification Category at 12-month Follow Up||12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1465126|NCT00739102|Secondary|Rutherford/Becker Classification at 30-day Follow Up|"The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows:~Stage 0 – Asymptomatic, no hemodynamically significant occlusive disease~Stage 1 – Mild claudication~Stage 2 – Moderate claudication~Stage 3 – Severe claudication~Stage 4 – Ischemic rest pain~Stage 5 – Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia~Stage 6 – Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
1465127|NCT00739102|Secondary|Index Limb Ischemia at 12-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1508305|NCT00411216|Secondary|Symptoms Intensity for Dizziness, Oscillopsia, Disequilibrium|visual analoque scales|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1465128|NCT00739102|Primary|Primary Safety Endpoint|Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30 days post procedure|||participants|||Number
1465129|NCT00739102|Secondary|Index Limb Ischemia at 6-month Follow up|Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.|6 months|Active subjects in the Modified ITT population at 6-month post procedure|||participants|||Number
1465130|NCT00739102|Secondary|Stent Fracture at 12-month Follow Up|Stent fracture was assessed by x-ray evaluation.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1465131|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1465132|NCT00739102|Secondary|Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure|A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven.|30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
1465133|NCT00739102|Secondary|Index Limb Amputation at 30-day Follow up|Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up.|30 day|Active subjects in the Modified ITT population at 30 days post procedure|||participants|||Number
1465134|NCT00739102|Secondary|Death at 12-month Post Procedure||12 months|Active subjects in the Modified ITT population at 12-month post procedure|||participants|||Number
1465135|NCT00739102|Secondary|Death Rate at 30-day Post Procedure||30 days|Active subjects in the Modified ITT population at 30-day post procedure|||participants|||Number
1465136|NCT00739102|Primary|12-month Primary Patency Rate|Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound.|12 months|As a subset of the modified ITT, this analysis population consisted of the subjects who had ultrasound assessment at 12 months or had target vessel revascularization (TVR) performed by 12 months.|||participants|||Number
1465137|NCT00739063|Primary|Time to Progression (TTP)|Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.|Baseline to disease progression, up to 22 months with follow up.|Study terminated early, unable to complete overall analysis due to insufficient data.|||months|||Number
1465138|NCT00739050|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1465139|NCT00739050|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks of Treatment|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1465140|NCT00739050|Secondary|Change in Total Cholesterol From Baseline at Week 12|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1465141|NCT00739050|Primary|Change From Baseline in Endothelial Thickness After 12 Weeks of Treatment.|The study was terminated; no outcome measure data analyses were conducted.|Baseline and 12 weeks|The study was terminated; no outcome measure data analyses were conducted. The Investigator was not able to recruit the required patients and was not able to get the necessary Computed Tomography equipment.||||||
1465142|NCT00739024|Primary|T-Test|It was planned to use a simple T-Test or ANoVa for data analysis. No Analysis was made due to insufficient recruitment. Planned primary efficacy variable was the percent reduction in the average monthly miqraine/probable migraine frequency from the baseline period to the entire double-blind treatment phase of the study.|4 weeks|||||||
1465143|NCT00738972|Primary|Left Ventricular Hypertrophy Reduction With Statins in Hypertensive Patients|Left ventricular hypertrophy reduction was to be measured by echocardiography.|6 Month(s)|This study was terminated early and due to sample size it was not possible to perform further statistical analyses.||||||
1465144|NCT00738894|Secondary|Number of Subjects With Effective Closure in Test (Device) Arm|"Assessment of PFO closure in test (device) arm subjects by transesophageal echocardiography (TEE) at 24-month follow-up.~Effective closure defined as occluded, small, or moderate shunt (0-25 bubbles)."|24 months|All subjects randomized to test (device) arm with 24-month PFO closure assessment|||Participants|||Count of Participants
1465146|NCT00738894|Primary|Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)|"Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days.~An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm."|24 months|Intention to Treat: includes all subjects randomized and evaluated for brain infarct|||Participants|||Count of Participants
1465147|NCT00738894|Primary|Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)|A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.|24 months|Intention to Treat: includes all subjects randomized|||Participants|||Count of Participants
1465148|NCT00738881|Secondary|Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)|Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. The proportion of patients with confirmed CR and PR will be computed within each treatment arm and exact binomial confidence intervals for the true proportion computed. Chi-square test and Fisher’s exact test will be used to compare the response rates between the treatment arms within the subgroups defined by FISH status, IHC, and MUT.|Up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
1465149|NCT00738881|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier survival curves. A 1-sided stratified log rank test [accounting for all the stratification factors except FISH status and cooperative group] will be used to compare overall survival between the erlotinib and pemetrexed arms within the FISH(+) and FISH(-) subgroups, compare overall and progression free survival between the erlotinib and pemetrexed arms within the subgroups defined on the basis of the epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC), and EGFR gene mutation status (MUT). Cox proportional hazards model will be used to assess potential differences.|Time from randomization to time of death from any cause, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
1465150|NCT00738881|Secondary|Time to Treatment Failure|The distribution of all time to event data will be estimated using the method of Kaplan-Meier survival curves.|The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years|Since the trial closed prematurely with only ~2% accrual, the secondary outcomes were not analyzed.||||||
1465151|NCT00738881|Primary|Progression-free Survival (PFS)|Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients ~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.|Time from randomization to the first date of documented disease progression or death, assessed up to 5 years|All the 23 randomized patients are eligible for primary end point analysis using an ITT principle.|||months||95% Confidence Interval|Median
1465152|NCT00738699|Other Pre-specified|Serologic Response Rate|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.||||||
1465153|NCT00738699|Other Pre-specified|Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.|Length of study|Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.||||||
1465154|NCT00738699|Secondary|Time to Tumor Response (TTR)|TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.|Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population (Responders only) included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Months||95% Confidence Interval|Median
1465155|NCT00738699|Secondary|Best Overall Response|BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).|Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Percentage of participants|||Number
1465156|NCT00738699|Primary|Overall Survival (OS)|OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.|Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|ITT population included all participants who were randomly assigned to study drug and analyzed by the treatment assigned.|||Months||95% Confidence Interval|Median
1465786|NCT00734630|Secondary|Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)||||mmHG||Standard Deviation|Mean
1465157|NCT00738699|Primary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).|Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months|Intent-To-Treat (ITT) population included all participants who were randomly assigned to study drug, analyzed by treatment assignment.|||Months||95% Confidence Interval|Median
1465158|NCT00738673|Secondary|Kaplan-Meier Estimate for Overall Survival|The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient’s data were censored at the date of last visit.|up to month 12|"Intent to treat population.~Analysis was not performed since no participants died during study."||||||
1465159|NCT00738673|Secondary|Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study|Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.|up to month 12|Intent to treat population|||participants|||Number
1465160|NCT00738673|Secondary|Participants at Testosterone Level <=0.32 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.|||participants|||Number
1465161|NCT00738673|Secondary|Participants at Testosterone Level <=0.2 ng/mL Throughout the Study|Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.|up to month 12|Full analysis set. Per the protocol, this analysis was only performed on Cohort 2.|||participants|||Number
1465162|NCT00738673|Secondary|Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||IU/L||Standard Deviation|Mean
1465163|NCT00738673|Secondary|Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit|LH is measured in IU/L|Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||percentage of baseline||Standard Deviation|Mean
1465164|NCT00738673|Secondary|Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||ng/mL||Standard Deviation|Mean
1465165|NCT00738673|Secondary|Change From Baseline in Serum Levels of Testosterone at the Last Visit||Day 0 (baseline), up to month 12 (last visit)|Intent to treat population with a baseline and at least one scheduled post-baseline measurement.|||ng/mL||Standard Deviation|Mean
1465166|NCT00738673|Secondary|Participants at Testosterone Castrate Level Throughout the Study|Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.|up to month 12|Intent to treat population|||participants|||Number
1465167|NCT00738673|Secondary|Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the two month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 2 months|Full analysis set of participants with baseline and month 2 values. Per protocol, the two month timeframe was only analyzed for cohort 2.|||percentage of participants||95% Confidence Interval|Number
1465168|NCT00738673|Secondary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level.~Per protocol, the one month timeframe was only analyzed for cohort 2."|Day 0 (baseline), 1 month|Full analysis set of participants with baseline and month 1 values. Per protocol, the one month timeframe was only analyzed for cohort 2.|||percentage of participants||95% Confidence Interval|Number
1465169|NCT00738673|Primary|Participants’ Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline|"Response to treatment was defined as:~Response (stabilisation or decrease): Difference ≤ +10% of Baseline level~No response (increase): Difference > +10% of Baseline level"|Day 0 (baseline), 3 months|Intent to treat population. Last observation carried forward.|||percentage of participants||95% Confidence Interval|Number
1465170|NCT00738543|Secondary|Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period|Presence of allergy or skin reaction at 24 hours after the application of the antiseptic|24 hours||||Number of participants with reaction|||Number
1465171|NCT00738543|Primary|Bacterial Colony Forming Units for the Control Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
1465172|NCT00738543|Primary|Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period|After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
1465173|NCT00738543|Secondary|Presence of Skin Reactions for the 10% Povidone-iodine Period|Presence of allergy or any skin reaction at 24 hours after the antiseptic application|24 hours|A minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL, with a power of 80%, and bilateral error of 5%. Analysis per protocol.|||Number of participants with skin reactio|||Number
1465174|NCT00738543|Primary|Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period|Bacterial colony count of skin cultures to determine antiseptic properties|24 hours||||Colony-forming units per cm squared||Inter-Quartile Range|Median
1465220|NCT00738062|Secondary|Clinician Recorded Clinical Global Impression - Severity|"The CGI-S is a 7 point scale ranging from a score of 1 (no symptoms) to 7 (severe symptoms). Patients were grouped according to OH severity at the end of the randomization period as follows;~Normal-Borderline OH (CGI-S 1-2),~Mild-Moderate OH (CGI-S 3-4),~Marked OH-Most Ill with OH (CGI-S 5-7)."|14 days||||participants|||Number
1465175|NCT00738530|Secondary|Change From Baseline in Karnofsky Performance Status|Karnofsky performance score is used to quantify participant’s general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Baseline, Week 7, 15, 23, 31, 43|Safety population: all participants randomized and exposed to study drug (8 randomized participants did not receive study treatment and were not included, 2 in bevacizumab and 6 in placebo group). 12 participants randomized to placebo received bevacizumab, were included in bevacizumab arm. n=number of evaluable participants at specified time point.|||score on a scale||Full Range|Median
1465176|NCT00738530|Secondary|Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to mRECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >=30% decrease under baseline of the sum of the LD of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.|||percentage of participants|||Number
1465177|NCT00738530|Secondary|Percentage of Participants With Objective Response According to mRECIST|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study. Number of participants analyzed (N) = participants with measurable disease at baseline.|||percentage of participants|||Number
1465178|NCT00738530|Secondary|Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to treatment failure was defined as the time between the date of randomization and the date of insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last tumor assessment or last treatment administration, whichever occurred last. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1465179|NCT00738530|Secondary|Percentage of Participants With Treatment Failure|Treatment failure is defined as insufficient therapeutic response (including disease progression), death, withdrawal of treatment due to adverse events or laboratory abnormality, or withdrawal of informed consent. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||percentage of participants|||Number
1465180|NCT00738530|Secondary|Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Time to progression was defined as the time between date of randomization and date of documented progression. Tumor assessment was performed using mRECIST. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event (including participants who died before progressive disease) were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1465195|NCT00738374|Secondary|Number of Participants With PD or Death After a Confirmed CR/CRi|Disease-free survival was defined at the time from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants with a confirmed CR or CRi were included in the analysis.|||participants|||Number
1465181|NCT00738530|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST. Progressive disease was defined as at least a 20 percentage(%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants without an event were censored at the date of last follow-up for progression or date of last available tumor measurement if no follow-up assessment for progression was performed. Participants who were randomized but not exposed to study drug and had no further follow-up were censored on the day of randomization.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1465182|NCT00738530|Secondary|Percentage of Participants With Disease Progression or Death|Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Baseline until disease progression or death, whichever occurred first (assessed at baseline, Weeks 8, 16, 24, 32, 44, 56, 68 thereafter every 12 weeks up to week 104 and then every 6 months up to 4.25 years)|ITT population included all participants randomized into the study.|||percentage of participants|||Number
1465183|NCT00738530|Primary|Overall Survival (OS) Duration|Duration of survival was defined as the time between the date of randomization and date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. Kaplan-Meier estimates were used for analysis.|Baseline until death (up to 4.25 years)|ITT population included all participants randomized into the study.|||months||95% Confidence Interval|Median
1465184|NCT00738530|Primary|Percentage of Participants Who Died||Baseline up to 4.25 years|ITT population included all participants randomized into the study.|||percentage of participants|||Number
1465185|NCT00738426|Secondary|Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ).||4 weeks|||||||
1465186|NCT00738426|Primary|Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.||2 weeks||||participants|||Number
1465187|NCT00738400|Secondary|Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))|Number of participants with no recorded titration of Vardenafil after visit 3.|week 4 and week 8||||Participants|||Number
1465188|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8|Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful ejaculations||95% Confidence Interval|Least Squares Mean
1465189|NCT00738400|Secondary|Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8|Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful erections||95% Confidence Interval|Least Squares Mean
1465190|NCT00738400|Secondary|"Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)"|Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')|up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.|||Percentage of participants|||Number
1465191|NCT00738400|Primary|Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8|Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent erection maintenance||95% Confidence Interval|Least Squares Mean
1465192|NCT00738400|Primary|Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8|Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.|Baseline and 8 weeks|Number of participants analyzed differs due to missing data.|||Percent successful penetrations||95% Confidence Interval|Least Squares Mean
1465193|NCT00738400|Primary|Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)|The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.|baseline and up to 8 weeks or LOCF|Number of participants analyzed differs due to missing data.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
1465194|NCT00738374|Secondary|Disease-Free Survival|The mean time, in days, from the date of first documented CR or CRi to the date of disease progression or death. CR, CRi, and PD as previously defined. Participants with no documented PD after CR or CRi were censored on the last date at which they were known to have had CR or CRi. In both groups, the mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|All randomized participants.|||days||Standard Error|Mean
1465198|NCT00738374|Secondary|OS|The mean time, in days, from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. The mean survival time and it's SE were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||Standard Error|Mean
1465199|NCT00738374|Secondary|Number of Participants Who Died|Overall Survival (OS) was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Participants were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1465200|NCT00738374|Secondary|Time to Next Treatment (TTNT)|The mean time, in days, from the date of the first dose of study treatment to the date of new CLL treatment or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment. Mean survival time and it's standard error (SE) were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||Standard Error|Mean
1465201|NCT00738374|Secondary|Number of Participants With New CLL Treatment or Death|Time to new CLL treatment (TTNT) was defined as the time from the first dose of study treatment to the date of new CLL treatment received or the date of death from any cause. Participants who did not receive new CLL treatment and were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without a follow-up assessment were censored at the day of last dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1465202|NCT00738374|Secondary|PFS|The median time, in days, from the date of the first dose of study treatment to the date of first documentation of disease progression or death. CR and PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||95% Confidence Interval|Median
1465203|NCT00738374|Secondary|Number of Participants With Disease Progression or Death|Progression-free survival (PFS) was defined as the time from the first dose of study treatment to the first documentation of disease progression or death. PD as previously defined. Participants who were withdrawn from the study without documented disease progression were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without a post-BL tumor assessment, but known to be alive, were censored at the time of the first dose of study treatment.|Screening, Day 1 Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1465204|NCT00738374|Secondary|EFS|The median time, in days, from the the date of first dose of study treatment to the date of first documentation of disease progression, relapse for participants with CR, death due to any cause, withdrawal due to AE, or new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose if study treatment. The 95% CI was determined using Kaplan-Meier methodology.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||days||95% Confidence Interval|Median
1465205|NCT00738374|Secondary|Number of Participants With Disease Progression, Relapse, Death, Withdrawal Because of an Adverse Event (AE), or New CLL Treatment|Event-free Survival (EFS) was defined as the time from the first dose of study treatment to the date of first documentation of disease progression, relapse for participants with previous CR, death due to any cause, withdrawal due to AE, or beginning new CLL treatment. CR and PD as previously defined. Participants were censored at the time of data cut-off to the most recent date of disease assessment. Participants without a post-BL disease assessment were censored at the time of first dose of study treatment.|Screening, Days 1 and 15 of Courses 1-8 (4-week courses) and Day 1 of Courses 10-35 (4-week courses) for up to 35 months.|ITT population|||participants|||Number
1465206|NCT00738374|Secondary|Percentage of Participants With Molecular CR - BM or Molecular CR - PB at the End of Study|Molecular CR was defined as the absence of MRD evaluated in participants who achieved CR by quantitative PCR in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants analyzed for the given parameter at the specified timepoint.|||percentage of participants|||Number
1465207|NCT00738374|Secondary|Percentage of Participants With Immunophenotypic CR - BM or Immunophenotypic CR - PB at the End of Study|Immunophenotypic CR was defined as the absence of MRD evaluated in participants who achieved CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 35|All randomized participants, only participants with a confirmed CR were included in the analysis.|||percentage of participants|||Number
1465208|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, SD, PD, or Relapse at the End of Study|CR, CRi, PR, SD, PD, relapse, and nodular PR as previously defined.|Month 35|All randomized participants.|||percentage of participants|||Number
1465209|NCT00738374|Secondary|Number of Participants With Immunophenotypic CR - BM, Immunophenotypic CR - Peripheral Blood (PB), Molecular CR - BM, or Molecular CR - PB at the End of Induction Treatment|Immunophenotypic CR was defined as the absence of minimal residual disease (MRD) evaluated in participants with CR by 4-color flow cytometry of PB and BM B cells to confirm that tissue was comprised of non-CLL cells. Molecular CR was defined as the absence of MRD evaluated in participants with CR by quantitative polymerase chain reaction (PCR) in PB and BM B cells to confirm that tissue was comprised of non-CLL cells.|Month 10|ITT population|||participants|||Number
1465210|NCT00738374|Secondary|Percentage of Participants With CR, PR, SD, PD, Relapse, or Nodular PR at the End of Study|CR, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a ≥ 50% increase in greatest diameter of any previously noted lesion; 2) a ≥50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 35|All randomized participants who were assessed at Month 35 were included in the analysis.|||percentage of participants|||Number
1465211|NCT00738374|Secondary|Percentage of Participants With CR, CRi, PR, Stable Disease (SD), Progressive Disease (PD), Relapse, or Nodular PR at the End of Induction Treatment|CR, CRi, and PR as previously defined. PD was defined by 1 of the following: 1) lymphadenopathy: any new lesion, HM/SM, or other organ infiltrates, or a greater than or equal to (≥) 50% increase in greatest diameter of any previously noted lesion; 2) a ≥ 50% increase in previously noted HM/SM, or new appearance of HM/SM; 3) a ≥ 50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to a more aggressive histology, e.g., Richter’s syndrome; or 5) occurrence of cytopenia attributable to CLL. SD was defined by the absence of necessary criteria to achieve CR or PR, but no advancement to PD. Relapse was defined by a previously noted CR or PR with advancement to PD after a period of ≥ 6 months. Nodular PR was defined by the presence of residual lymphoid nodules.|Month 10|ITT population|||percentage of participants|||Number
1465212|NCT00738374|Secondary|Percentage of Participants With Documented CR, CRi, or PR at the End of Study|CR defined as: 1) laboratory CR: PBL <4000/μL, PMN > 1500/μL, platelets > 100,000/μL, and Hb > 11 g/dL; 2) clinical CR: LN < 1.5 cm, and no constitutional symptoms, HM or SM; 3) instrumental CR: LN < 1.5 cm and no HM/SM, and 4) bone marrow CR: normocellular aspirate/biopsy for participant age < 30% lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to CLL, with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from BL in the HM/SM, and 1 of the following: PMN > 1500/μL, platelets > 100,000/μL or > 50% improvement from BL, and Hb >11.0 g/dL or > 50% improvement from BL.|Month 35|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1465213|NCT00738374|Primary|Percentage of Participants With Documented CR, CRi, or PR at the End of Induction Treatment|CR defined as: 1) laboratory CR: peripheral blood lymphocytes (PBL) less than (<) 4000/microliter (μL), neutrophils (PMN) greater than (>) 1500/μL, platelets >100,000/μL, and hemoglobin (Hb) >11 grams per deciliter (g/dL); 2) clinical CR: lymph nodes (LN) <1.5 centimeter (cm), and no constitutional symptoms, hepatomegaly (HM) or splenomegaly (SM); 3) instrumental CR: LN <1.5 cm and no HM/SM, and 4) bone marrow (BM) CR: normocellular aspirate/biopsy for participant age <30 percent (%) lymphocytes, and no B cell lymphoid nodules. CRi was defined as CR with anemia, thrombocytopenia, or neutropenia not related to chronic lymphocytic leukemia (CLL), with no clonal infiltrate in aspirate or biopsy. PR defined as: a 50% decrease in PBL, a 50% decrease in LN size, no increase in LN size, no new enlarged LN, a 50% reduction from baseline (BL) in the HM/SM, and 1 of the following: PMN >1500/μL, platelets >100,000/μL or >50% improvement from BL, and Hb >11.0 g/dL or >50% improvement from BL.|Month 10|Intent to treat (ITT) population: all consented participants who received at least 1 dose of rituximab.|||percentage of participants||95% Confidence Interval|Number
1465214|NCT00738361|Secondary|Overall Survival|Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.|up to 1 year following last treatment, for a total of approximately 5 years||||months||Standard Error|Mean
1465215|NCT00738361|Secondary|Progression-free Survival|Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel|up to 1 year following last treatment, for a total of approximately 5 years|all patients progressed at the time of first scan|||months||95% Confidence Interval|Median
1465216|NCT00738361|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 1 year following last treatment, for a total of approximately 5 years||||patients|||Number
1465217|NCT00738283|Primary|Zinc Absorption|"Zinc fractional absorption was measured using a dual tracer stable isotope method in which 67Zn was given orally with a single feed followed immediately by infusion of 70Zn intravenously. A spot urine sample was collected 96 hours after the infusion and the relative dose-corrected enrichments used to calculate fractional absorption at the time oral isotope was administered.~Tracer:tracee ratios (TTR), measured by ICP-MS, were used to calculated fractional zinc absorption."|96 hours after single feed infusion|Relationships between zinc absorption, zinc excretion (urine or fecal) and zinc balance, and potential explanatory variables were analyzed using the GLM model function of JMP 7 for Macintosh (SAS inc, Cary, NC). Simple and multiple regression analysis were used as appropriate. Significance was assumed at a p < 0.05.|||fractional zinc absorption (%)||Standard Deviation|Mean
1465218|NCT00738062|Secondary|Clinician Rated Clinical Global Impressions - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days||||participants|||Number
1465219|NCT00738062|Secondary|Patient Reported Clinical Global Impression - Improvement|"The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.~Patients will be grouped according change in disease as follows;~Very Much Improved to Slightly Improved (CGI-I 1-3),~No Change (CGI-I 4),~Slightly Worse to Very Much Worse (CGI-I 5-7)."|14 days||||participants|||Number
1466216|NCT00732940|Secondary|Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
1465222|NCT00738062|Post-Hoc|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients were on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days||||units on a scale||Standard Deviation|Mean
1465223|NCT00738062|Secondary|Change in Systolic Blood Pressure (SBP) Measurements 3 Minutes Post Standing|Change: standing systolic blood pressure at end of study minus standing systolic blood pressure at randomization. In this withdrawal design, a negative score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization to either continued droxidopa or to placebo.|14 days||||mmHg||Standard Deviation|Mean
1465224|NCT00738062|Secondary|Change in Orthostatic Hypotension Symptom Assessment (OHSA) Composite Score|"The OHSA scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. Each asks the patient to rate their symptoms over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days||||units on a scale||Standard Deviation|Mean
1465225|NCT00738062|Secondary|Change in Orthostatic Hypotension Daily Activities (OHDAS) Score|"The OHDAS scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each asks the patient to rate their disease impact over the past week. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~Change: score at end of randomization minus score at randomization. In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug)."|14 days|One droxidopa patient excluded from analysis because data were not evaluable.|||units on a scale||Standard Deviation|Mean
1465226|NCT00738062|Primary|Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)|"The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-scale is the average of four items: 1) Standing for a short time; 2) Standing for a long time; 3) Walking for a short time; and 4) Walking for a long time. Each item is scored on a Likert scale from 0 to 10, with 10 being the most severe.~In this withdrawal design, a positive score indicates worsening during the double-blind randomized phase relative to value at randomization (on open-label drug). All patients are on open-label droxidopa for 3 months prior to randomization."|14 days|"The analysis population was based on the ITT population of all patients randomized. Last observation carry forward was used for patients who prematurely discontinued the study.~One droxidopa patient was excluded from the analysis because OHQ values were not evaluable."|||units on a scale||Standard Deviation|Mean
1465227|NCT00738049|Secondary|Change During Darusentan Treatment in the Coronary Flow Reserve (CFR)|CFR is calculated as the unitless ratio between hyperemic to resting flow|0, 2, 4, and 6 weeks||||no units||Standard Deviation|Mean
1465228|NCT00738049|Secondary|Change During Darusentan Treatment in Absolute Flow at Rest and Hyperemia||0, 2, 4, and 6 weeks||||cc/min/gm||Standard Deviation|Mean
1465229|NCT00738049|Primary|Change During Darusentan Treatment in the Markovian Homogeneity Number, a Value That Quantitates Myocardial Perfusion Heterogeneity|Markovian homogeneity analysis characterizes an image produced by a PET scan by examining the probability that a pixel with a given intensity will have a neighbor with a different intensity. The homogeneity index ranges from >0 to 1, where a value near 0 represents an image with a high probability that neighboring pixels have intensity values that differ greatly, and a value near 1 represents an image with a high probability that neighboring pixels have similar intensity values.|0, 2, 4, and 6 weeks|Statistical analysis is exploratory, therefore not easily planned. A paired t-test with 40 subjects will provide approximately 89% power to test the null hypothesis of no change in the homogeneity number versus a two-sided alternative at alpha= 5%,if the true mean change is 0.15,e.g.,a homogeneity index of 0.5 at baseline and 0.65 after darusentan.|||No units||Standard Deviation|Mean
1465230|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Intralipid Infusion Post-rosiglitazone Intervention|Systolic blood pressure change from baseline during an 48-hour intralipid infusion after taking rosiglitazone for 6 weeks in obese diabetic subjects|48 hours||||mmHg||Standard Error|Mean
1465231|NCT00738023|Secondary|Changes in Systolic Blood Pressure During Saline Infusions|Systolic blood pressure change from baseline during an 48-hour normal saline infusion in obese diabetic subjects|48 hours||||mmHg||Standard Error|Mean
1465232|NCT00738023|Primary|Changes in Systolic Blood Pressure During Initial Intralipid Infusion|Systolic blood pressure change from baseline during an 48-hour intralipid infusion|Baseline, 48 hours||||mmHg||Standard Error|Mean
1465233|NCT00737737|Secondary|Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?||4 weeks||||ng/ml|||Number
1465234|NCT00737737|Primary|Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?||4 weeks||||ng/ml|||Number
1465235|NCT00737711|Secondary|Mean Serum Alkaline Phosphatase Over Time|Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||U/L||Standard Deviation|Mean
1465499|NCT00736385|Secondary|Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1465236|NCT00737711|Secondary|Mean Alanine Aminotransferase Over Time|Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||U/L||Standard Deviation|Mean
1465237|NCT00737711|Secondary|Mean Aspartate Transaminase Over Time|Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Units/Liter (U/L)||Standard Deviation|Mean
1465238|NCT00737711|Secondary|Mean Serum Bilirubin Over Time|Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1465239|NCT00737711|Secondary|Mean Serum Phosphate Over Time|Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1465240|NCT00737711|Secondary|Mean Serum Sodium Over Time|Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mmol/L||Standard Deviation|Mean
1465241|NCT00737711|Secondary|Mean Serum Potassium Over Time|Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
1465242|NCT00737711|Secondary|Mean Blood Urea Nitrogen Over Time|Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1465243|NCT00737711|Secondary|Mean Serum Creatinine Over Time|Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mg/dL||Standard Deviation|Mean
1465244|NCT00737711|Secondary|Mean Serum Globulin Over Time|Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
1465245|NCT00737711|Secondary|Mean Serum Albumin Over Time|Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||g/dL||Standard Deviation|Mean
1465246|NCT00737711|Secondary|Mean Transferrin Saturation Over Time|Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Percentage of transferrin saturation||Standard Deviation|Mean
1465247|NCT00737711|Secondary|Mean Total Iron-binding Capacity Over Time|Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||mcg/dL||Standard Deviation|Mean
1465248|NCT00737711|Secondary|Mean Transferrin Over Time|Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
1465249|NCT00737711|Secondary|Mean Serum Ferritin Over Time|Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||nanogram /milliliter (ng/mL)||Standard Deviation|Mean
1465250|NCT00737711|Secondary|Mean Serum Iron Over Time|Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||microgram/deciliter (mcg/dL)||Standard Deviation|Mean
1465251|NCT00737711|Secondary|Mean Platelet Count Over Time|Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
1465252|NCT00737711|Secondary|Mean Hypochromic Red Blood Cells Over Time|Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
1465253|NCT00737711|Secondary|Mean Value of Mean Corpuscular Volume Over Time|Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Femtoliter||Standard Deviation|Mean
1465254|NCT00737711|Secondary|Mean White Blood Cell Count Over Time|The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.|Baseline (Week 0), Week 4, Week 10, and Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||cells per cubic millimeter||Standard Deviation|Mean
1465255|NCT00737711|Secondary|Number of Participants With Reports of Anti-Epoetin Antibodies|Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug.|||Participants|||Number
1465256|NCT00737711|Secondary|Number of Participants With Reports of Blood Transfusions|Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.|Up to Week 16|The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.|||Participants|||Number
1465257|NCT00737711|Secondary|Number of Participants With Abnormal Electrocardiogram|Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.|Up to Week 16|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.|||Participants|||Number
1465258|NCT00737711|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 18|Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.|||Participants|||Number
1465259|NCT00737711|Secondary|Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
1465260|NCT00737711|Secondary|Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10–12 g/dL) during the last 4 weeks of the TP is presented.|Week 12 to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||Weeks||Standard Deviation|Mean
1465261|NCT00737711|Secondary|Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter|Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.|Up to Week 16|The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||Weeks||Standard Deviation|Mean
1465262|NCT00737711|Primary|Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period|The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.|Baseline (Week 0) and Week 16|The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.|||gram/deciliter (g/dL)||Standard Deviation|Mean
1465266|NCT00737672|Secondary|Circuit Primary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465267|NCT00737672|Secondary|Circuit Primary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465268|NCT00737672|Secondary|Circuit Primary Patency|"Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.~P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve."|6 months||||Percentage of Subjects||95% Confidence Interval|Number
1465269|NCT00737672|Primary|Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure|The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.|30 days||||Participants|||Number
1465270|NCT00737672|Primary|Target Lesion Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~P-Value calculated from 24-month data cohort after study completion."|24 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465271|NCT00737672|Secondary|Access Secondary Patency [24 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465272|NCT00737672|Secondary|Access Secondary Patency [12 Months] Units Percentage of Subjects|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465273|NCT00737672|Secondary|Access Secondary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.~Six-month estimate of secondary access patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465274|NCT00737672|Secondary|Assisted Primary Patency at 24 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve."|24 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465275|NCT00737672|Secondary|Assisted Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve."|12 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465276|NCT00737672|Secondary|Assisted Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.~Six-month estimate of assisted primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465277|NCT00737672|Primary|Target Lesion Primary Patency at 12 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|12 Months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465278|NCT00737672|Primary|Target Lesion Primary Patency at 6 Months|"Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.~Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve."|6 months|Percent of subjects maintaining patency based on Kaplan-Meier estimate based on per-protocol (effectiveness) population.|||Percentage of Subjects||95% Confidence Interval|Number
1465279|NCT00737633|Secondary|Percent Weight Change From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)|||percent change||Standard Deviation|Mean
1465280|NCT00737633|Primary|Change in HbA1c From Baseline to Week 72||Baseline to 72 weeks|Intent-to-treat (ITT)|||percent change||Standard Deviation|Mean
1465281|NCT00737594|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment|Study terminated early, data was not analyzed.|4 weeks|||||||
1465282|NCT00737568|Secondary|Development of Drug-resistant Mutations (DRMs)|The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs.|Baseline to Week 240|Full Analysis Set|||participants|||Number
1465283|NCT00737568|Secondary|Percent Change From Baseline in BMD of the Hip at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set with hip BMD measurements at the given time point were included in the analysis.|||percentage change||Standard Deviation|Mean
1508306|NCT00411216|Secondary|Activities Specific Balance Confidence Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1465284|NCT00737568|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of the Spine at Weeks 24, 48, 72, 96, 144, 192, and 240|BMD is calculated as grams per cubic centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240|Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) with spine BMD measurements at the given time point were included in the analysis.|||percentage change||Standard Deviation|Mean
1465285|NCT00737568|Secondary|Percentage of Participants With Virologic Breakthrough at Weeks 48, 96, 144, 192, and 240|The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being < 400 copies/mL.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set; the missing-equals-excluded method was used in which participants with missing data were excluded from the analysis.|||percentage of participants|||Number
1465286|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBV Surface Antigen (Anti-HBs) at Weeks 48, 96, 144, 192, and 240|The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1465287|NCT00737568|Secondary|Percentage of Participants With HBV Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1465288|NCT00737568|Secondary|Percentage of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.|||percentage of participants|||Number
1465289|NCT00737568|Secondary|Percentage of Participants With HBeAg Loss at Weeks 48, 96, 144, 192, and 240|The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.|Baseline; Weeks 48, 96, 144, 192, and 240|Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed using the missing = failure method.|||percentage of participants|||Number
1465290|NCT00737568|Secondary|Percentage of Participants With Normal ALT at Weeks 48, 96, 144, 192, and 240|Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69.|Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1465291|NCT00737568|Secondary|HBV DNA Level at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full analysis set; participants with HBV DNA measurements at the given time point were included in the analysis.|||log10 copies/mL||Standard Deviation|Mean
1465292|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, 192, and 240||Weeks 48, 96, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1465293|NCT00737568|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 144, 192, and 240||Weeks 48, 144, 192, and 240|Full Analysis Set, missing = failure method|||percentage of participants|||Number
1465294|NCT00737568|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 96||Week 96|Full Analysis Set: participants were randomized and received at least 1 dose of study drug. The missing = failure method was used in which participants with missing data were considered to have failed to achieve the endpoint.|||percentage of participants|||Number
1465295|NCT00737529|Secondary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: Following is the scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|From the first dose of Lenalidomide through cycle 6 plus 28 days of last dose of Lenalidomide (maximum duration of study drug was 1006 days) and up to data cut off 02 July 2012|The Safety Population (received at least one dose of Lenalidomide) was used for all safety analysis and was identical to the ITT population.|||participants|||Number
1465296|NCT00737529|Secondary|Overall Survival (OS)|Kaplan Meier estimates of OS was calculated from the time the first dose of study drug to death from any cause. Participants who had not died were censored at the last date the participant was known to be alive.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of overall survival was conducted in the ITT population|||months||95% Confidence Interval|Median
1465297|NCT00737529|Secondary|Progression-free Survival (PFS)|Kaplan Meier estimates of PFS was defined as the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever comes first. If a participant had not progressed or died, PFS was censored at the time of last adequate assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last adequate tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; and/or of the data-cut off of 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of progression free survival was conducted in the ITT population|||months||95% Confidence Interval|Median
1465298|NCT00737529|Secondary|Time to Treatment Failure (TTF)|Time to treatment failure (TTF) was calculated from the start of study drug therapy to early discontinuation from treatment due to any cause, including disease progression, toxicity, or death and was based on site-reported data.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to treatment failure was conducted in the ITT population|||months||95% Confidence Interval|Median
1465299|NCT00737529|Secondary|Time to Progression (TTP)|Kaplan Meier estimate of time to progression was calculated as time from the start of the study drug therapy to the first observation of disease progression. Participants who died without progression were censored at the date of death; otherwise, the censoring rules presented above for PFS applied to the analysis of TTP. Progressive Disease(PD): Appearance of new lesion or increase by ≥50% from previously involved sites from nadir|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to progression was conducted in the ITT population|||months||95% Confidence Interval|Median
1465300|NCT00737529|Secondary|Time to Complete Response (CR+CRu)|Time to Complete Response (CR+CRu) was defined as the time from the first dose of study drug to the date of the first occurrence of at least CRu and was calculated only for participants with CR or CRu.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with a CR. The minimum and maximum are referenced in the measure of dispersion under full range.|||months||Full Range|Median
1465301|NCT00737529|Secondary|Duration of Complete Response (DoCR) (CR+CRu)|Kaplan Meier estimates for the duration of CR/CRu was calculated from the date of the first occurrence of CR/CRu to the date of documented disease progression or death (without documented progression) for participants who obtained a CR/CRu; participants who had not progressed (or died) were censored at the last valid assessment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with a CR.|||months||95% Confidence Interval|Median
1465302|NCT00737529|Primary|Duration of Response (DoR)|Kaplan Meier estimates for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease progression (any new lesion or increase by ≥ 50% of previously involved sites from nadir) or death (without documented progression) for participants who responded; participants who had not progressed (or died) were censored at the last valid assessment.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles and/or data cut-off of 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|Participants in the ITT population with an overall response|||months||95% Confidence Interval|Median
1465303|NCT00737529|Secondary|Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu)|The percentage of participants whose best response was CR or CRu. Participants who had discontinued before CR/CRu was observed, or changed to other antilymphoma treatments before a CR/CRu response had been observed, were considered as non-responders. CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; Non-responders are participants who discontinue before any post-baseline efficacy assessments.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; Data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of the complete response rate (CCR) was conducted using the IRC in the ITT population|||percentage of participants||95% Confidence Interval|Number
1465304|NCT00737529|Secondary|Time to Response (TTR)|TTR was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants.|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of time to response was calculated only for responding participants. The minimum and maximum are referenced in the measure of dispersion under full range.|||months||Full Range|Median
1465305|NCT00737529|Primary|Percentage of Participants With an Overall Response|Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who had discontinued before any response has been observed, or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses|Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks|An analysis of overall response was conducted in the Intent To Treat population (ITT) defined as all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
1465306|NCT00737477|Secondary|Percentage of Participants Requiring Blood Transfusions|The percentage of participants who received at least one red blood cell transfusion during the overall treatment period (Weeks 0 to 48) was calculated.|Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants|||Number
1465331|NCT00737464|Secondary|Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time|Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.|From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.|||mmHg||Standard Deviation|Mean
1465307|NCT00737477|Secondary|Percent Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percent difference in dose from the previous week was calculated at each visit as [(current dose minus previous week dose) divided by previous week dose] multiplied by 100, and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."|||percent change in dose||Standard Deviation|Mean
1465308|NCT00737477|Secondary|Absolute Change in Dose of Mircera/CERA by Study Week|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The absolute difference in dose from the previous week was calculated at each visit and averaged among all participants.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis at each timepoint (n) is shown in the table."|||mcg||Standard Deviation|Mean
1465309|NCT00737477|Secondary|Number of Dose Adjustments of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The number of dose adjustments performed for each participant was averaged among all participants for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."|||dose adjustments||Standard Deviation|Mean
1465310|NCT00737477|Secondary|Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA|Study drug administration occurred monthly during treatment (Weeks 0 to 48), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during the initial 4-week screening period. Subsequent doses could be adjusted on the basis of Hb levels or other modification criteria. The percentage of participants who required any dose adjustment (including decreased dose, increased dose, and dose not performed) was calculated for Weeks 4 to 20, Weeks 24 to 48, and Weeks 4 to 48.|Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data for each analysis within each timeframe (n) is shown in the table."|||percentage of participants|||Number
1465311|NCT00737477|Secondary|Percentage of Participants With Down Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one down excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one down excursion."|||percentage of participants|||Number
1465312|NCT00737477|Secondary|Percentage of Participants With Up Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA during the DAP, EEP, and follow-up. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) in Hb >1.5 g/dL lasting longer than 4 weeks. The percentage of participants with at least one up excursion was calculated for Weeks 4 to 16, Weeks 16 to 24, and Weeks 24 to 44."|Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants with at least one up excursion."|||percentage of participants|||Number
1465313|NCT00737477|Secondary|Percentage of Participants With Cycles or Excursions|"Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Cycles were defined as a change in Hb greater than (>) 1.5 g/dL lasting longer than 8 weeks. Excursions were defined as half of one full cycle, or an increase (up excursions) or decrease (down excursions) >1.5 g/dL lasting longer than 4 weeks according to Hb measurements collected during the study. The percentage of participants with at least one cycle or excursion during Weeks 4 to 44 was calculated."|Weeks 4 to 44|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants|||Number
1465314|NCT00737477|Secondary|Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit|Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had average Hb during the EEP (Weeks 16 to 24) and follow-up (Weeks 28 to 48) in the target range (10 to 12 g/dL) and within ±1 g/dL of their individual reference Hb was determined by study visit.|Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data at each timepoint (n) is shown in the table."|||percentage of participants|||Number
1465315|NCT00737477|Secondary|Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range (10 to 12 g/dL) was defined as time from first on-target Hb measurement to time of last known on-target Hb measurement, as collected during the EEP (Weeks 16 to 24) and the overall treatment period (Weeks 0 to 48). Time spent in the target range was averaged among all participants and expressed in weeks.|Weeks 16 to 24 and Weeks 0 to 48|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data. The number of participants who provided sufficient data within each timeframe (n) is shown in the table."|||weeks||Standard Deviation|Mean
1465316|NCT00737477|Secondary|Change in Hb Value From Baseline to the EEP|"Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment screening period (Weeks -4 to 0). Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., Baseline) Hb and the EEP average Hb was calculated and expressed in g/dL."|Baseline and Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||g/dL||Standard Deviation|Mean
1465317|NCT00737477|Secondary|Percentage of Participants With Hb Values Within Target Range During the EEP|During the EEP (Weeks 16 to 24), participants provided a total of three pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The percentage of participants who had at least one, two, or all three Hb values during the EEP in the target range (10 to 12 g/dL) was determined.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data for at least one Hb value. The number of participants who provided sufficient data for each analysis (n) is shown in the table."|||percentage of participants|||Number
1465318|NCT00737477|Primary|Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP|Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.|Weeks 16 to 24|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided sufficient data."|||percentage of participants||95% Confidence Interval|Number
1465319|NCT00737464|Secondary|Mean Values of Serum Sodium and Serum Potassium Over Time|Mean values of serum sodium and serum potassium were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||millimole per liter||Standard Deviation|Mean
1465320|NCT00737464|Secondary|Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time|Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||miligram per deciliter||Standard Deviation|Mean
1465321|NCT00737464|Secondary|Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time|Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||units per litre||Standard Deviation|Mean
1465322|NCT00737464|Secondary|Mean Values of Serum Albumin and Serum Globulin Over Time|Mean values of serum albumin and serum globulin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||gram per deciliter||Standard Deviation|Mean
1465323|NCT00737464|Secondary|Mean Values of Transferrin Saturation Over Time|Mean values of Transferrin Saturation (TSAT) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Percentage||Standard Deviation|Mean
1465324|NCT00737464|Secondary|Mean Values of Transferrin Over Time|Mean values of transferrin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||miligram per mililiter||Standard Deviation|Mean
1465325|NCT00737464|Secondary|Mean Values of Serum Ferritin Over Time|Mean values of serum ferritin were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||nanogram per mililiter||Standard Deviation|Mean
1465326|NCT00737464|Secondary|Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time|Mean values of serum iron and total iron binding capacity (TIBC) were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||microgram per deciliter||Standard Deviation|Mean
1465327|NCT00737464|Secondary|Mean Corpuscular Volume Levels Over Time|Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||femtoliters||Standard Deviation|Mean
1465328|NCT00737464|Secondary|Mean Values of Hypochromic Red Blood Cells Over Time|Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Percentage of RBCs||Standard Deviation|Mean
1465329|NCT00737464|Secondary|Mean Values of White Blood Cells and Platelets Over Time|Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.|At Weeks -2, 4, 8, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Per cubic millimeter||Standard Deviation|Mean
1465330|NCT00737464|Secondary|Number of Participants With Abnormal Electrocardiogram|Participants with abnormal electrocardiogram were reported.|At Week -2 and Week 12|Safety population included all enrolled participants who received at least one dose of study drug. n = the number of participants analyzed at a given time point.|||Number of participants|||Number
1465373|NCT00737061|Secondary|Patient Satisfaction With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting somewhat satisfied, satisfied or very satisfied.|48 hours|Intent to treat population; no imputations for missing data. Minimum satisfaction reported as 605/625 participants.|||percentage of participants|||Number
1465332|NCT00737464|Secondary|Mean Change From Baseline in Heart Rate Over Time|Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.|From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12|Safety population included all enrolled participants who received at least one dose of study drug. n = number of participants analyzed at a given time point.|||Beats per minute (bpm)||Standard Deviation|Mean
1465333|NCT00737464|Secondary|Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths|Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|Safety population included all enrolled participants who received at least one dose of study drug.|||Number of participants|||Number
1465334|NCT00737464|Secondary|Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL|Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.|Up to Week 12|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||Weeks||Standard Deviation|Mean
1465335|NCT00737464|Secondary|Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)|The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||gm/dL||Standard Deviation|Mean
1465336|NCT00737464|Primary|Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)|Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 – 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.|Weeks 8 to 12 (Last 4 weeks of treatment period)|Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.|||Percentage of participants||95% Confidence Interval|Number
1465337|NCT00737438|Primary|Overall Response Will be Characterized by the Patient's FDG-PET Scan|A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline.|2 years||||participants|||Number
1465338|NCT00737360|Secondary|Safety|Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.|Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.|All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation.|||number of participants|||Number
1465339|NCT00737360|Secondary|Overall Survival|Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.|12 months after enrollment of the last patient||||day||95% Confidence Interval|Median
1465340|NCT00737360|Secondary|Antitumor Activity|"Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR., or similar text that was as accurate and appropriate."|Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.|Antitumor activity was the rate of best overall objective responses(complete response + partial response).|||participants|||Number
1465341|NCT00737360|Primary|Progression Free Survival(PFS)|PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.|From the date of registration until the earliest date of documented disease progression, death, or censoring event.|One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes.|||day||95% Confidence Interval|Median
1465342|NCT00737282|Primary|To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)||12 months|Study prematurely terminated||||||
1465343|NCT00737243|Secondary|Number of Participants With a Tissue of Origin Successfully Predicted by the Assay|To evaluate the utility of the assay in identifying the tissue of origin in patients with carcinoma of unknown primary site (CUP), an archived tumor specimen was assayed upon study entry. If a tissue of origin was predicted by the assay, participants received standard site-specific therapy for that tumor type. When tissue of origin was not predicted by the assay, patients received standard empiric chemotherapy for CUP and were not followed further. If the assay was not completed due to inadequate amount of tumor in the biopsy specimen, patients were not treated on the study.|at baseline|Of 252 participants analyzed, the assay correctly predicted the tissue of origin in 247 patients (98%). The predicted tissue of origin could not be determined in 5 participants (2%).|||participants|||Number
1465500|NCT00736385|Secondary|Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1465344|NCT00737243|Primary|Overall Survival|Defined as the elapsed time from the start of treatment to the date of death from any cause or lost to follow-up. Participants lost to follow up were censored as of the last date known to be alive.|every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months|Of 223 treated patients: 194 received assay-directed therapy; 29 received empiric CUP therapy. The 194 patients who received assay-directed therapy were separated into groups based on predicted responsiveness of the tumor type for further analysis.|||months||95% Confidence Interval|Median
1465345|NCT00737204|Secondary|HIV Viral Load|"HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated under 50 copies, which was the assay's lowest limit of detectability during the study."|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Log10 copies/mL||Standard Deviation|Mean
1465346|NCT00737204|Secondary|CD4 Cell Count|Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >=100 cells. A higher number is associated with better immune functioning.|Measured at baseline and Week 4|Results were included for patients on whom baseline and week 4 labs were drawn.|||Cells/mcL||Standard Deviation|Mean
1465347|NCT00737204|Primary|Role Function Scale|The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.|Measured at Baseline and Week 4|The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward.|||units on a scale||Standard Deviation|Mean
1465348|NCT00737204|Primary|Fatigue Severity Scale(FSS) Outcome|The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.|Measured at baseline and Weeks 4|Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat).|||units on a scale||Standard Deviation|Mean
1465349|NCT00737178|Primary|Use of the IUD for Contraception at Six Months|Six months after enrollment, we determined whether or not women were using the IUD through in-person exit interviews and phone interviews. This was an intention to treat analysis, comparing the proportion of women using the IUD based on their group assignment (immediate or delayed).|6 months||||participants|||Number
1465350|NCT00737178|Secondary|Expulsion and Removal Rates|"Expulsion rates were defined as the number of IUDs expelled from the uterus among participants who had the IUD inserted during the study.~Removal rates were defined as the number of IUDs that were electively removed by participant request among participants who had the IUD inserted during the study."|Within six months of medication abortion|Per protocol: insertion and removal rates were calculated only for participants undergoing IUD insertion|||participants|||Number
1465351|NCT00737178|Secondary|Insertion Rates|Insertion rates are the proportion of women in each allocation group (immediate, delayed) who ultimately had the IUD inserted within the 6 month study period.|By six months after medication abortion||||participants|||Number
1465352|NCT00737100|Secondary|Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation|Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.|From first drug administration until 30 days after last drug administration (up to 121 days)|Treated set|||participants|||Number
1465353|NCT00737100|Secondary|Time From Dosing to the Maximum Concentration (Tmax,ss)|Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||h||Full Range|Median
1465354|NCT00737100|Secondary|Maximum Measured Concentration at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
1465355|NCT00737100|Secondary|Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)|Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state|pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement - patients >= 12 years|||ng||Geometric Coefficient of Variation|Geometric Mean
1465356|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Parent Questionnaire|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
1465357|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adolescents Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
1465374|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|Including Second Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 611/645 participants after 7 participants underwent a successful second attempt.|||percentage of participants|||Number
1465358|NCT00737100|Secondary|Change From Baseline in CFQ Scores - Adult Group|The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||units on a scale||Standard Deviation|Mean
1465359|NCT00737100|Secondary|Respiratory and Systemic Symptoms Questionnaire (RSSQ)|Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.|12 weeks|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Participants|||Number
1465360|NCT00737100|Secondary|Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12|Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1465361|NCT00737100|Secondary|Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12|Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1465362|NCT00737100|Secondary|Percent Predicted FVC Trough Response at the End of Week 12|Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1465363|NCT00737100|Secondary|Percent Predicted FVC AUC0-4 Response at the End of Week 12|Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1465364|NCT00737100|Primary|Percent Predicted FEV1 Trough Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1465365|NCT00737100|Primary|Percent Predicted FEV1 AUC0-4 Response at the End of Week 12|Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.|Baseline, Week 12|Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement|||Percentage change||Standard Error|Least Squares Mean
1465366|NCT00737061|Secondary|3 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period who have been followed for up to 3 years.|3 years|Population includes all participants able to rely on Adiana (n=570). This analysis is cumulative and based on survival analysis methodology. Thus, participants only followed for 2 years, for example, would still be included in this cumulative analysis. In total, 481 participants were available with 3 years of follow-up at the time of analysis.|||percentage of participants|||Number
1465367|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum comfort reported at 12-Months as 530/532 participants.|||percentage of participants|||Number
1465368|NCT00737061|Secondary|Patient Comfort With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint represents minimum percentage of subjects reporting good, very good or excellent comfort.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum comfort reported at 1-Month as 604/608 participants.|||percentage of participants|||Number
1465369|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions up to 48 hours post placement. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced in first 48 hours following procedure as the same as they expected, less than they expected or no pain.|48 hours|Intent to treat population; no imputations for missing data. Minimum comfort reported as 578/632 participants.|||percentage of participants|||Number
1465370|NCT00737061|Secondary|Patient Comfort With Placement Procedure|Determined by verbal questions two hours following procedure or at discharge from facility, whichever came first. Endpoint reported represents minimum percentage of participants reporting any discomfort or pain experienced during the procedure as the same as or less than they expected.|Post-Procedure|Intent to treat population; no imputations for missing data. Minimum comfort reported as 504/629 participants.|||percentage of participants|||Number
1465371|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Wearing Period (3-Months, 6-Months, 9-Months, 12-Months)|Per protocol population; no imputations for missing data. Minimum satisfaction reported at 12-Months as 528/531 participants.|||percentage of participants|||Number
1465372|NCT00737061|Secondary|Patient Satisfaction With Device Wearing|Determined by verbal questions during periodic follow-up contacts. Endpoint reported represents minimum percentage of subjects reporting somewhat satisfied, satisfied or very satisfied.|Waiting Period (1-Month, 2-Months, 3-Months)|Intent to treat population; no imputations for missing data. Minimum satisfaction reported at 2-Months as 587/613 participants.|||percentage of participants|||Number
1465375|NCT00737061|Secondary|Device Placement Rate|Defined as successful bilateral tubal access followed by successful bilateral RF treatment and matrix placement.|After First Treatment Attempt|Device placement rate reported on a per participant basis for 645 intent to treat participants. Successful bilateral placement of the matrices was achieved in 604/645 participants after the first procedure.|||percentage of participants|||Number
1465376|NCT00737061|Primary|1 Year Pregnancy Rate|Pregnancy rate is defined as the cumulative percentage of pregnancies occuring within the time frame. The primary endpoint for this study is the pregnancy prevention rate after one year of reliance on the Adiana System for pregnancy prevention. The pregnancy rate was evaluated for all participants who underwent successful bilateral treatment and who had demonstrated tubal occlusion by hysterosalpingogram (HSG) at the end of the Waiting Period.|1 year|645 participants had treatment attempted; Intent to Treat population. Of these 645, 570 were able to rely on the device and are used to evaluate the pregnancy prevention rate for the 1-year endpoint. During the 1-year follow-up period, there were 6 pregnancies, of which 3 were attributable to physician error, i.e., misinterpretation of HSG results.|||percentage of participants|||Number
1465377|NCT00737048|Secondary|Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain|"Percentage of participants were assessed with treatment response based on evaluation criteria for efficacy of analgesics in post-tooth-extraction pain for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as very effective, effective, somewhat effective and ineffective for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as extremely useful, useful, not useful & could not be assessed for overall evaluation (OE)."|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Percentage of participants|||Number
1465378|NCT00737048|Secondary|Number of Participants Treated With a Relief Analgesic|Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Participants|||Number
1465379|NCT00737048|Secondary|Percentage of Participants With Categorical Score for Patient Impressions|Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn’t work.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Percentage of participants|||Number
1465380|NCT00737048|Secondary|Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy|Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points.|||Minutes||Standard Deviation|Mean
1465381|NCT00737048|Secondary|Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465382|NCT00737048|Secondary|Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465383|NCT00737048|Secondary|Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment|The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465384|NCT00737048|Secondary|Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment|Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.|0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465419|NCT00736944|Primary|Clinical Complete Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size."|post-2 cycles of induction (approximately 42 days from start of treatment)|All patients who completed 2 cycles of induction therapy.|||participants|||Number
1465385|NCT00737048|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)|The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465386|NCT00737048|Secondary|Sum of Pain Intensity Difference (SPID)|Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score).|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465387|NCT00737048|Secondary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|Baseline up to 8 hours post-administration of study treatment|FAS population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465388|NCT00737048|Primary|Total Pain Relief Based on Numerical Rating Scale (NRS) Score|Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.|8 hours|Final analysis set (FAS) population included all the participants who received the study treatment and had efficacy assessment data.|||Units on a scale||Standard Deviation|Mean
1465389|NCT00736996|Secondary|Change in Peak Oxygen Uptake (VO2 Peak)|Peak oxygen consumption (VO2 peak, ml/kg/min) was determined by open circuit spirometry during a standard treadmill stress test (modified Balke protocol).|Baseline to 6 months||||ml/kg/min||95% Confidence Interval|Number
1465390|NCT00736996|Secondary|Change in Insulin Resistance|Change in whole body glucose disposal rate (mg/kg/min) calculated during a single-stage (40 mU/m2/min), 3-hour hyperinsulinemic, euglycemic clamp|Baseline to 6 months||||mg/kg/min||95% Confidence Interval|Number
1465391|NCT00736996|Primary|Change in Cognitive Performance|Participants were administered a neuropsychological testing battery consisting of assessments in four cognitive domains: memory (Visual Reproduction II, Logical Memory II, Rey Auditory Verbal Learning Test), language (Boston Naming Test , Category Fluency), visuospatial (Block Design, Picture Completion), and executive function (Trail Making Test B, Digit Symbol Test). Raw test scores for these primary cognitive domain measures were transformed into age-adjusted scaled scores with a mean of 10 and a standard deviation (SD) of 3, with higher numbers indicating better cognitive performance, using the Mayo’s Older American Normative Studies data. Cognitive domain scores were calculated as the arithmetic mean of the normatively derived scaled scores for all of the tests in that domain.|Baseline to 6 months||||units on a scale||95% Confidence Interval|Number
1465392|NCT00736957|Secondary|Change From Baseline in Short Form-36 (SF-36) Score|SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status.|Baseline, Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure and n = the number of participants with measurements for that time point.|||units on a scale||Standard Deviation|Mean
1465393|NCT00736957|Secondary|Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4|PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on scale||Standard Deviation|Mean
1465394|NCT00736957|Secondary|Pain Relief (PAR) Score at Week 4|Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1465395|NCT00736957|Secondary|Pain Intensity Difference (PID) at Week 4|PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved).|Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Participants showing a Pain Intensity (PI) value of 0 prior to dosing at each evaluation time point were not included in the analysis.|||units on a scale||Standard Deviation|Mean
1465458|NCT00736645|Secondary|Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction|Compare cleaved caspase 3 values with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of cleaved caspase 3 values of Arm A, Arm B, Arm D with Arm C.|1 year|All treated and eligible patients|||percentage of apoptotic cells||Full Range|Median
1465396|NCT00736957|Secondary|Number of Participants With Improvement From Baseline in VAS24 Score|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Week 4 and 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment. Last Observation Carried Forward (LOCF) method was used.|||participants|||Number
1465397|NCT00736957|Primary|Change From Baseline in VAS24 Score at Week 52|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 52|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.|||millimeter||Standard Deviation|Mean
1465398|NCT00736957|Primary|Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4|Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement.|Baseline and Week 4|Full analysis set included all participants who met the eligibility criteria, received study medication and had at least one post-treatment efiicacy assessment.|||millimeter||Standard Deviation|Mean
1465399|NCT00736944|Secondary|Progression-free Survival|Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
1465400|NCT00736944|Secondary|Disease Free Survival|Time from complete response to death from any cause, to disease progression or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
1465401|NCT00736944|Secondary|Overall Survival|Time from diagnosis to death or to last follow-up alive.|10 years from completion of treatment||2020-08-31|08/2020||||
1465402|NCT00736944|Secondary|Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis||completion of the first 10 patients induction chemotherapy||||participants|||Number
1465403|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.|||participants|||Number
1465404|NCT00736944|Secondary|Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = intensity of SPARC staining in tumor|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.|||participants|||Number
1465405|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were partial responders.|||participants|||Number
1465406|NCT00736944|Secondary|Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy|SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Patients who had available tumor tissue for SPARC testing and were complete responders.|||participants|||Number
1465407|NCT00736944|Secondary|Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|1 patient was not evaluable for CT scan because the primary site could not be clearly measured and was noted as non-target lesion. 1 patient was not evaluable for PET scan because the patient's insurance company denied coverage.|||percentage of participants|||Number
1465408|NCT00736944|Secondary|Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|12 patients were not evaluable for VSR because they did not have nodal disease. 6 patients were not evaluable for CT scan because 5 patients did not have nodal disease and 1 patient didn't have measurable nodal disease. 5 patients were not evaluable for PET because 5 patients did not have nodal disease.|||percentage of participants|||Number
1465427|NCT00736879|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants|Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values. Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|Baseline (Day 1), Week 24|N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.|||Adjusted Percentage of participants|||Number
1465409|NCT00736944|Secondary|Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT|"In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests.~We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease.|||percentage of participants|||Number
1465410|NCT00736944|Secondary|Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion.|||participants|||Number
1465411|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST.|||participants|||Number
1465412|NCT00736944|Secondary|Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria|"Complete response rate per RECIST criteria is defined as disappearance of all target lesions.~Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline.|||participants|||Number
1465413|NCT00736944|Other Pre-specified|Overall Complete and Partial Response Rates by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|One patient was not evaluable for this outcome. This patient's insurance company denied coverage for the post-cycle 2 timepoint and because of this was not included in this overall response rate for PET scan.|||participants|||Number
1465414|NCT00736944|Secondary|Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured.|||participants|||Number
1465415|NCT00736944|Secondary|Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan|"Complete response rate defined as complete resolution of the metabolically active primary tumor.~Partial response rate defined as 20% or greater decrease in maximum SUV [SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan.|||participants|||Number
1465416|NCT00736944|Secondary|Clinical Overall Complete and Partial Response Rates|"Clinical exam included laryngoscopy in office or operating room.~Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days)||||participants|||Number
1465417|NCT00736944|Secondary|Clinical Complete and Partial Response Rates to the Involved Regional Nodes|"Clinical exam consisted of physical exam of neck in office.~Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size.~Partial response rate defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam.|||participants|||Number
1465418|NCT00736944|Secondary|Clinical Partial Response Rate at the Primary Tumor|"Clinical exam included laryngoscopy in office or operating room.~Partial response rate (PR) defined as 50% to 94% decrease in tumor size."|post-2 cycles of induction therapy (approximately 42 days from start of treatment)|Participants who completed 2 cycles of induction therapy|||participants|||Number
1465457|NCT00736723|Primary|Pattern of NT-proBNP, Biomarkers and Surface Markers on Leukocytes|maximal NT-proBNP concentrations in critically ill surgical patients admitted from 01 July 2008 to 31 Dec 2008 in the ICU revealingnonseptic and septic shock|01 July 2008 to 31 Dec 2008||||pg/ml||Full Range|Median
1465420|NCT00736879|Secondary|Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants|Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX, >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.|Baseline to Week 24/end of treatment plus 4 days|N=Number of participants who received at least 1 dose of study medication and had non-missing laboratory results.|||participants|||Number
1465421|NCT00736879|Secondary|Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants|12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.|Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline (BL) and Week 24 (LOCF) values.|||participants|||Number
1465422|NCT00736879|Secondary|Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants|Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.|||bpm||Standard Error|Mean
1465423|NCT00736879|Secondary|Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants|Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Participants who took at least 1 dose of double-blind study medication were analyzed. n= number of treated participants with non-missing baseline and Week 24 values.|||mmHg||Standard Error|Mean
1465424|NCT00736879|Secondary|Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants|Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.|Baseline to last dose plus 4 days in 12 Week Double Blind Period|Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs summarized below were prior to rescue.|||participants|||Number
1465425|NCT00736879|Secondary|Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants|Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.|Day 1 of Double Blind Period to end of Week 24 Plus 30 days|Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.|||participants|||Number
1465426|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants|Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation carried forward, (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||cm||Standard Error|Mean
1508307|NCT00411216|Secondary|Disability Scale|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1465428|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants|Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control. At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.|Baseline (Day 1), Week 24|Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
1465429|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in fasting plasma glucose (FPG) from baseline at Week 24 (LOCF) was determined. Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.|Baseline (Day 1), Week 24|Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Mean
1465430|NCT00736879|Secondary|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants|Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||kg||Standard Error|Mean
1465431|NCT00736879|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants|Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.|Baseline (Day 1), Week 24|N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.|||Percent Hemoglobin||Standard Error|Mean
1465432|NCT00736853|Secondary|Change From Baseline in SF-36 at Day 28 of Double-Blind Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465433|NCT00736853|Secondary|Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period|The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1465434|NCT00736853|Secondary|Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465435|NCT00736853|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period|The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1465436|NCT00736853|Secondary|Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465437|NCT00736853|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period|The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.|Day 1 and Day 14 of open-label period|Efficacy analysis set included who received at least one dose of study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1465438|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465439|NCT00736853|Secondary|Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period|The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief.|Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
1465440|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Double-Blind Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465441|NCT00736853|Secondary|Total Pain Relief (TOTPAR) Score During the Open-Label Period|The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.|Day 1 and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
1465442|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465443|NCT00736853|Secondary|Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period|The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Day 1, and Day 8 of open-label period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1465444|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465459|NCT00736645|Primary|Effects of Selenium and Finasteride and Their Combination on PSA Level|Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.|1 year|All treated and eligible patients|||ng/mL||Full Range|Median
1465445|NCT00736853|Secondary|Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period|The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included who received at least one dose of study medication. Here 'n' signifies number of participants evaluable for each time point.|||units on a scale||Standard Deviation|Mean
1465446|NCT00736853|Secondary|Mean PAR Score During the Double-Blind Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465447|NCT00736853|Secondary|Mean Pain Relief (PAR) Score During the Open-Label Period|PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.|2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1465448|NCT00736853|Secondary|Mean PID During the Double-Blind Period|The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465449|NCT00736853|Secondary|Mean Pain Intensity Difference (PID) During the Open-Label Period|The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.|Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1465450|NCT00736853|Secondary|Mean PI Score During Double-Blind Period|The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
1465451|NCT00736853|Secondary|Mean Pain Intensity (PI) Score During Open-Label Period|PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.|Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period|Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point.|||units on a scale||Standard Deviation|Mean
1465452|NCT00736853|Secondary|Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 and Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.|||mm||Standard Deviation|Mean
1465453|NCT00736853|Secondary|Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period|Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.|Day 1 of open-label period and Day 1 of double-blind period|Efficacy analysis set included participants who received at least one dose of study drug.|||mm||Standard Deviation|Mean
1465454|NCT00736853|Primary|Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period|The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.|Day 28 of double-blind period|Efficacy analysis set included participants who received at least one dose of the study drug.|||number of participants|||Number
1465455|NCT00736840|Secondary|AUC of ROC (Area Under Receiver Operating Characteristic Curve)|The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.|At study day 1 after 1 hour test||||Probability||95% Confidence Interval|Mean
1465456|NCT00736840|Primary|"Number of Subjects With Likelihood of Cirrhosis Based on Hepatic Impairment Score (HIS)"|"Hepatic Impairment Score (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard."|Study day 1 after a 1 hour test|The primary efficacy was conducted on all evaluable subject data in the full analysis (FA)set with biopsy confirmed cirrhosis.|||Participants|||Number
1465460|NCT00736580|Secondary|Surgeon Satisfaction by Likert Scale.||1 week|||||||
1465463|NCT00736502|Secondary|Virologic Response (VR)|VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.|48 weeks|TS|||Participants|||Number
1465464|NCT00736502|Primary|Proportion of Patients Reporting Adverse Events|the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.|48 weeks|The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.|||Percentage of participants|||Number
1465465|NCT00736489|Secondary|Plasma AZD3199 AUC0-24|Area under the plasma concentration curve from time 0 to 24 h post-dose|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.|||nmol*h/L||Full Range|Geometric Mean
1465466|NCT00736489|Secondary|Plasma AZD3199 Cmax|Maximum plasma concentration of AZD3199 measured|0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set.|||nmol/L||Full Range|Geometric Mean
1465467|NCT00736489|Secondary|Palpitations, Average Effect Over 0 - 4 h Post-dose|Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1465468|NCT00736489|Secondary|Palpitations, Peak Effect Over 0 - 4 h Post-dose|Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1465469|NCT00736489|Secondary|Tremor, Average Effect Over 0 - 4 h Post-dose|Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1465470|NCT00736489|Secondary|Tremor, Peak Effect Over 0 - 4 h Post-dose|Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h.|0, 15min, 30min, 1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis.|||Score on a scale||Standard Deviation|Mean
1465471|NCT00736489|Secondary|QTcB, Average Effect Over 0 - 4 h Post-dose|Average QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||ms||Standard Deviation|Mean
1465472|NCT00736489|Secondary|QTcB, Peak Effect Over 0 - 4 h Post-dose|Maximum QTc Bazett over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||ms||Standard Deviation|Mean
1465473|NCT00736489|Secondary|Heart Rate, Average Effect Over 0 - 4 h Post-dose|Average heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1465474|NCT00736489|Secondary|Heart Rate, Peak Effect Over 0 - 4 h Post-dose|Maximum heart rate over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1465475|NCT00736489|Secondary|Pulse, Average Effect Over 0 - 4 h Post-dose|Average pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1465476|NCT00736489|Secondary|Pulse, Peak Effect Over 0 - 4 h Post-dose|Maximum pulse over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||bpm||Standard Deviation|Mean
1465477|NCT00736489|Secondary|Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1465478|NCT00736489|Secondary|Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Minimum DBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1465479|NCT00736489|Secondary|Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose|Average SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1465480|NCT00736489|Secondary|Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose|Maximum SBP value over 4 h|0, 30min, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences.|||mmHg||Standard Deviation|Mean
1465554|NCT00736099|Secondary|Change in FPG From Baseline to Week 18||Baseline and week 18|Treated Set with values for FPG at baseline and at week 18. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1465481|NCT00736489|Secondary|FEV1 Average Effect Over 12 - 24 h Post-dose|FEV1 average effect over 12 h night-time period|12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1465482|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 12 h Post-dose|FEV1 average effect over 12 h day-time period|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1465483|NCT00736489|Secondary|FEV1 Average Effect Over 0 - 24 h Post-dose|FEV1 average effect over 24 h dosing interval|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1465484|NCT00736489|Secondary|FEV1 Effect at 5 Min Post-dose|FEV1 at 5 minutes|5min|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on Placebo and 1 on AZD3199 480 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1465485|NCT00736489|Primary|S-potassium, Average Effect Over 0 - 4 h Post-dose|Average S-potassium concentration|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||mmol/L||Standard Deviation|Mean
1465486|NCT00736489|Primary|S-potassium, Peak Effect Over 0 - 4 h Post-dose|Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.|0, 15min, 30min,1h, 2h, 4h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis.|||mmol/L||Standard Deviation|Mean
1465487|NCT00736489|Primary|E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.|Residual FEV1 24 h post-dose|22- 26 h post dose|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1465488|NCT00736489|Primary|FEV1 Peak Effect Within 0 - 24 h Post-dose|Maximum FEV1 value|0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h|Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis.|||L||Standard Deviation|Mean
1465489|NCT00736476|Secondary|Proliferative Response Against the Pooled H. Pylori Vaccine Antigens by Stimulation Index (SI)|The proliferation of H. pylori-specific Peripheral blood mononuclear cells (PBMCs) following HP antigen stimulation was assessed to measure the magnitude of the cell mediated immune response.|12 weeks post HP challenge|Per-protocol dataset|||Stimulation Index (SI)||Standard Deviation|Mean
1465490|NCT00736476|Secondary|Response on Activated Regulatory T Cell Subset Following HP Vaccination and HP Challenge|The response to 3 doses of HP vaccine and the oral HP challenge was assessed with respect their ability to induce differentiation and changes in the phenotype of a subset of regulatory T-cells CD4+CD25+Foxp3+ that expresses Treg Markers PD-1 and/or HLA-DR.|12 weeks post HP challenge|Per-protocol dataset|||percentage of T-cells||Standard Deviation|Mean
1465491|NCT00736476|Secondary|Geometric Mean Concentrations Against Vaccine Antigens After HP Challenge.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP) after HP challenge were compared between vaccinated and placebo groups.|12 months|Per-protocol dataset|||μg/mL||95% Confidence Interval|Geometric Mean
1465492|NCT00736476|Secondary|The Geometric Mean Concentrations After HP Vaccination.|The geometric mean concentration of IgG antibody responses to each of the HP vaccine antigens (VacA, CagA and NAP)after HP vaccination as compared to placebo are reported.|upto 1 month after 3rd vaccination|Per-Protocol dataset|||μg/mL||95% Confidence Interval|Geometric Mean
1465493|NCT00736476|Secondary|The Time Course of HP Infection Following HP Challenge in Vaccinated and Placebo Groups|The time course of HP infection following HP challenge in subjects of the HP vaccine and placebo groups, were assessed by non-invasive HP tests.|12 months||||Participants|||Number
1465494|NCT00736476|Primary|Number of Subjects Reporting Solicited Local* and Systemic Adverse Events Following Vaccination|To assess the tolerability of an HP vaccine versus placebo in terms of number of subjects reporting solicited local* and systemic adverse events.|Day 1-7 post vaccination|This analysis was done on the safety dataset|||Participants|||Number
1465495|NCT00736476|Primary|The Efficacy (Defined as Prevention of Infection) of the HP Vaccine Compared to Placebo.|"The efficacy of the investigational vaccine to prevent infection following H.pylori challenge in healthy adults was determined in terms of percentage of subjects with positive HP infections in the vaccinated and unvaccinated groups(Placebo).~Infection rates was assessed by invasive Upper Gastrointestinal Endoscopy (UGE)tests that included HP histopathology, HP culture and rapid urease test (RUT), and non-invasive HP tests which included urea breath test (UBT) and fecal antigen test (FAT)."|12 weeks post HP challenge|Per-protocol dataset|||Percentage of subjects|||Number
1465496|NCT00736450|Secondary|Efficacy of Treatment, in Terms of Complete Response Rate (Anyone Achieving a CR or Cru)|Response criteria are the recommendations of the International Harmonization Project’s update to the International Working Group guidelines. Complete response (CR) is defined as disappearance of all evidence of disease; Partial response (PR) is defined as regression of measurable disease and no new sites|End of treatment, an average of 4 months||||Participants|||Count of Participants
1465501|NCT00736385|Secondary|Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1465502|NCT00736385|Primary|Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.||24 months|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
1465503|NCT00736333|Primary|Number of Times Premedications Were Given for Prevention of PPE|Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.|Day 1 up to 24 weeks|Safety population (those who received at least one dose of study medication)|||Number of times premedication was given|||Number
1465504|NCT00736333|Primary|Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)|PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.|Up to 24 weeks|Safety population (those who received at least one dose of study medication)|||Occurrences|||Number
1465505|NCT00736333|Primary|Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR|Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.|Cycles 1 & 3 (Week 4 & Week 12)|Safety population (those who received at least one dose of study medication)|||Participants|||Number
1465506|NCT00736333|Primary|Percent of Participants Taking Premedication for Prevention of IR|Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.|Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin|Safety population (those who received at least one dose of study medication)|||Percent of participants|||Number
1465507|NCT00736333|Secondary|Number of Participants With Complete Response (CR) or Partial Response (PR)|CR and PR were documented according to the clinical standards of each site.|Day 1 up to 24 weeks|Intent-to-treat (those who received at least one dose of study medication)|||Participants|||Number
1465508|NCT00736333|Primary|Number of Participants With Infusion Reactions (IR)|Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.|Day 1 up to Week 24|Safety population (those who received at least one dose of study medication)|||Participants|||Number
1465509|NCT00736255|Secondary|Clinician Rated Clinical Global Impressions of Improvement Scale (CGI-I)|Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment.|Visits 2, 4, 6, & 8|||||||
1465510|NCT00736255|Secondary|Cognitive Functioning|This is measured by Continuous Performance Test (CPT) and N-Back|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8|||||||
1465511|NCT00736255|Secondary|ADHD CAARS Self-Report and Observer Short Forms|T-scores derived from compiled ADHD symptoms from two forms.|Randomization, visit 2, 4, 6, 8|||||||
1465512|NCT00736255|Secondary|Continuous Performance Test (CPT) Reaction Time Standard Error|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8||||Reaction time in seconds||Standard Deviation|Mean
1465513|NCT00736255|Secondary|Continuous Performance Test (CPT) Commission Errors|The CPT is a measure of both vigilance/sustained attention and response inhibition, has good normative data and has been shown to be sensitive to the effects of stimulants. Reaction time variability and commission errors – measures of attentional control and response inhibition have been shown to be sensitive in discriminating individuals with ADHD on active medication versus placebo.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8||||Errors of Commission||Standard Deviation|Mean
1465514|NCT00736255|Secondary|Smoking Rates|Smoking rates, measured as self-reported cigarettes/day.|Randomization, visit 1, 2, 3, 4, 5, 6, 7, 8|||||||
1465515|NCT00736255|Primary|The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels < 4 Ppm for Each Post-quit Study Visit.|The primary outcome measure was the proportion of subjects in each treatment group exhibiting sustained, 4-week smoking abstinence, defined as CO levels < 4 ppm for each post-quit study visit. Subjects who dropped from the study for any reason were considered to have lapsed.|4 weeks|Subjects exhibiting sustained 4 week smoking abstinence defined as CO levels <4ppm for each post quit study visit were analyzed for the outcome measure.|||participants|||Number
1465516|NCT00736242|Secondary|Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment|"An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a~congenital anomaly or birth defect."|From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).|Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion.|||participants|||Number
1465517|NCT00736242|Secondary|Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment|The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.|From the Baseline Visit up to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available.|||cells/μL||Full Range|Median
1465518|NCT00736242|Secondary|Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment.~HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing"|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.|||participants|||Number
1465519|NCT00736242|Secondary|Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment|"HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR).~HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing."|From the Baseline Visit up to EOF (up to 72 weeks)|Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.|||participants|||Number
1465520|NCT00736242|Secondary|Participant Study Status at End of Follow-up (EOF)|"Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA.~SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT."|From EOT to EOF (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.|||participants|||Number
1465521|NCT00736242|Secondary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as undetectable serum HCV-RNA at week 12 and/or a~≥2 log decline in HCV-RNA levels at week 12 from baseline."|From Treatment Week 1 to Treatment Week 12|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12.|||participants|||Number
1465522|NCT00736242|Secondary|Number of Participants With Rapid Virologic Response (RVR)|RVR was defined as undetectable serum HCV-RNA at week 4.|At Treatment Week 4|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4|||participants|||Number
1465523|NCT00736242|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).|From End of Treatment to 24 weeks post-treatment (up to 72 weeks)|Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus [HIV] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.|||participants|||Number
1465524|NCT00736229|Secondary|Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)||30 days||||participants|||Number
1465525|NCT00736229|Secondary|Rates of Hypoglycemia and Severe Hypoglycemia|Total number of patients having at least one hypoglycemic episode (blood glucose less than 70 mg/dl), including episodes classified as severe (blood glucose less than 50 mg/dl)|1-48 hours||||participants|||Number
1465526|NCT00736229|Primary|Time to Steady State|Time to steady state was defined as the time from the initiation of drug infusion (Exenatide or Insulin) to first glucose value that is ≤140 mg/dl.|Start of infusion through 48 hours or until discharge||||hours||Inter-Quartile Range|Median
1465527|NCT00736229|Primary|Median Glucose Values From Steady State Through 48 Hours or Until Discharge.|Time to steady state was defined as the time from the initiation of drug infusion to first glucose value that is ≤140 mg/dl. Median glucose values were then calculated for each patient from the start of steady state through 48 hours or until discharge.|1-48 hours|Intention to treat|||mg/dL||Inter-Quartile Range|Median
1465528|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Who Discontinued the Study Early|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, discontinued TDF treatment after Week 24 with HBV DNA >= 400 copies/mL, and had serum sample for testing.|||Participants|||Number
1465529|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants With Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|2 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and had virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).|||Participants|||Number
1465530|NCT00736190|Secondary|Summary of Resistance Surveillance for Participants Without Virologic Breakthrough|Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples.|Week 48|10 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and did not have virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir).|||Participants|||Number
1465555|NCT00736099|Secondary|Change in FPG From Baseline to Week 6||Baseline and week 6|Treated Set with values for FPG at baseline and at week 6. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1468203|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 1 Year|Number of participants with clinically significant infections at 1 year|1 year post transplant||||Participants|||Count of Participants
1465531|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||2099-01-31|01/2099||||
1465532|NCT00736190|Secondary|Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss|Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48||2099-01-31|01/2099||||
1465533|NCT00736190|Secondary|Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48|Blood samples from study participants were collected for measuring HBV DNA via PCR method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1465534|NCT00736190|Secondary|Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion|HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48.|Week 48||||Participants|||Number
1465535|NCT00736190|Secondary|Change From Baseline in FibroTest Value|The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant’s age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline and Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Scores on a scale||Standard Deviation|Mean
1465536|NCT00736190|Secondary|Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48|Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1465537|NCT00736190|Secondary|Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48|A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L)|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study, received at least one dose of study drug, and had baseline ALT > ULN (34 U/L).|||participants|||Number
1465538|NCT00736190|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48|Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1465539|NCT00736190|Primary|Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)|Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method.|Week 48|The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug.|||Participants|||Number
1465540|NCT00736125|Secondary|Biomarkers of Neuronal Damage||Within 72 hours after surgery|||||||
1465541|NCT00736125|Secondary|Systemic Inflammatory Response (SIRS) Markers||Within 72 hours after surgery|||||||
1465542|NCT00736125|Secondary|Cardiac Injury||Within 3 days after surgery|||||||
1465543|NCT00736125|Secondary|Changes in Pulmonary and Renal Function||Within 3 days after surgery|||||||
1465544|NCT00736125|Secondary|Delirium During Hospital Stay||First 3 days after surgery|||||||
1465545|NCT00736125|Secondary|Changes in Neurocognitive Tests Following Surgery||2 weeks prior to 1 year following surgery|||||||
1465546|NCT00736125|Secondary|Number of Patients With Emboli in the High Category||During surgery||||Patients w/ emboli in high category|||Number
1465547|NCT00736125|Primary|The Number of Cerebral Emboli During Surgery as Measured by Transcranial Doppler (TCD)||During surgery||||emboli|||Number
1465548|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Cholesterol|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Cholesterol|||participants|||Number
1465549|NCT00736099|Secondary|Change in FPG From Baseline to Week 78||Baseline and week 78|Treated Set with values for FPG at baseline and at week 78. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1465550|NCT00736099|Secondary|Change in FPG From Baseline to Week 66||Baseline and week 66|Treated Set with values for FPG at baseline and at week 66. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1465551|NCT00736099|Secondary|Change in FPG From Baseline to Week 54||Baseline and week 54|Treated Set with values for FPG at baseline and at week 54. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1465552|NCT00736099|Secondary|Change in FPG From Baseline to Week 42||Baseline and week 42|Treated Set with values for FPG at baseline and at week 42. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1465553|NCT00736099|Secondary|Change in FPG From Baseline to Week 30||Baseline and week 30|Treated Set with values for FPG at baseline and at week 30. Values after rescue therapy are set to missing.|||mg/dL||Standard Deviation|Mean
1465566|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Lactate Dehydrogenase (LDH)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for LDH|||participants|||Number
1465567|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Albumin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 2.5 g/dL.|78 weeks|Treated Set with values for Albumin|||participants|||Number
1465568|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alkaline Phosphatase (AP)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 times the ULN.|78 weeks|Treated Set with values for AP|||participants|||Number
1465569|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Bilirubin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 2 mg/dL.|78 weeks|Treated Set with values for Bilirubin|||participants|||Number
1465570|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Glucose|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 54 mg/dL.|78 weeks|Treated Set with values for Glucose|||participants|||Number
1465571|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Aspartate Transaminase (AST)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for AST|||participants|||Number
1465572|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Alanine Transaminase (ALT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for ALT|||participants|||Number
1465573|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Sodium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 130 mmol/L (decrease) or a value greater than 160 mmol/L (increase).|78 weeks|Treated Set with values for Sodium|||participants|||Number
1465574|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Calcium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 1.8 mmol/L (decrease) or a value greater than 3 mmol/L (increase).|78 weeks|Treated Set with values for Calcium|||participants|||Number
1465575|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Phosphate|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 0.7 mmol/L (decrease) or a value greater than 1.7 mmol/L (increase).|78 weeks|Treated Set with values for Phosphate|||participants|||Number
1465576|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine Kinase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for Creatinine kinase|||participants|||Number
1465577|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Creatinine|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 1.5 mg/dL.|78 weeks|Treated Set with values for Creatinine|||Participants|||Number
1465578|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: γ-Glutamyl-transferase (GGT)|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than or equal to 3 times the ULN.|78 weeks|Treated Set with values for GGT|||Participants|||Number
1465579|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Amylase|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 1.5 times the upper limit of normal (ULN).|78 weeks|Treated Set with values for Amylase|||Participants|||Number
1465580|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Triglycerides|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 300 mg/dL.|78 weeks|Treated Set with values for Triglycerides|||Participants|||Number
1465581|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Uric Acid|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value greater than 11 mg/dL for male and as a value greater than 10 mg/dL for female patients.|78 weeks|Treated Set with values for Uric acid|||Participants|||Number
1465582|NCT00736099|Primary|Number of Patients With Abnormalities in Clinical Chemistry: Potassium|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 mmol/L (decrease) or a value greater than 5.8 mmol/L (increase).|78 weeks|Treated Set with values for Potassium|||participants|||Number
1465583|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Platelets|For this laboratory parameter, a possibly clinically significant abnormality is defined as value less than or equal to 75 * 10^9/L (decrease) or a value greater than or equal to 700 * 10^9/L (increase).|78 weeks|Treated Set with values for Platelets|||Participants|||Number
1465584|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: White Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^9/L (decrease) or a value greater than 20.1 * 10^9/L (increase).|78 weeks|Treated Set with values for White blood cell count|||Participants|||Number
1465585|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Red Blood Cell Count|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than 3 * 10^12/L.|78 weeks|Treated Set with values for Red blood cell count|||Participants|||Number
1465586|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haematocrit|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 32%.|78 weeks|Treated Set with values for Haematocrit|||Participants|||Number
1465587|NCT00736099|Primary|Number of Patients With Abnormalities in Haematology: Haemoglobin|For this laboratory parameter, a possibly clinically significant abnormality is defined as a value less than or equal to 11.5 g/dL for male and as a value less than or equal to 9.5 g/dL for female patients.|78 weeks|Treated Set with values for Haemoglobin|||Participants|||Number
1465590|NCT00736099|Primary|Frequency of Patients With Adjudication of Cardiac and Cerebrovascular Events|Patients reported with cardiac and cerebrovascular events qualified for adjudication by the Clinical Event Committee (CEC)|78 weeks|Treated Set: all screened patients who were documented to have taken at least 1 dose of study drug|||participants|||Number
1465591|NCT00736099|Primary|Frequency of Patients With Significant Adverse Events Based on Standardised MedDRA Query (SMQ)|As significant adverse events are considered: renal Aes (SMQ 'acute renal failure'), hypersensitivity reactions ('anaphylactic reactions' and 'angioedema'), hepatic Aes ('hepatitis, non-infectious', 'hepatic failure, fibrosis, cirrhosis and other liver damage-related conditions', 'liver-related investigations, signs and symptoms', 'cholestasis and jaundice of hepatic origin'), severe cutaneous adverse reactions ('severe cutaneous adverse reaction'), pancreatitis ('acute pancreatitis', 'chronic pancreatitis'').|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1465592|NCT00736099|Primary|Frequency of Patients With Investigator-defined Hypoglycaemic Adverse Events||78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1465593|NCT00736099|Primary|Frequency of Patients With Adverse Events (AEs)|This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.|78 weeks|Treated Set: all screened patients who were documented to have taken at lease 1 dose of study drug.|||Participants|||Number
1465594|NCT00736073|Secondary|Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis||7 days||||participants|||Number
1465595|NCT00736073|Secondary|Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis||48 hours post ERCP and 1 week post ERCP|There are 2 telephone assessments that participants are required to complete in order to analyze the outcome measure. The study team was unable to collect both assessments within the required timeframe due missed calls & lack of return calls from participants. Therefore data collection and analysis could not be completed per protocol.||||||
1465596|NCT00736073|Primary|Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).||48 hours|The number of participants who received the aprepitant or placebo were evaluated for ERCP pancreatitis. Each case of ERCP pancreatitis was tracked for the participant.|||cases of ERCP in participants|||Number
1465597|NCT00736034|Secondary|Clinical Global Impression of Change (CGI-C)Scale|The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician’s global impression of change. Global improvement score ranges from 1 = “Very much improved”, through 4 = “No change”, to 7 = “Very much worse”. Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period.|15 weeks|||||||
1465598|NCT00736034|Primary|Change From Baseline in Neuropsychological Computerized Test|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|baseline, 15 weeks||||Points on a scale||Standard Deviation|Mean
1465599|NCT00735969|Primary|Sustained Virological Response, (HCV RNA Neg.) in Serum 24 Weeks Off Therapy.||24 weeks after treatment stop||||participants|||Number
1465600|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1465601|NCT00735943|Secondary|Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield). Improvement in OCT parameters was measured based on this single parameter.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1465602|NCT00735943|Secondary|Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy|VA was measured using ETDRS chart at 4 meter distance, at 1 meter distance (if patient’s VA was poor) or verifying if the patient was able only to count fingers, to perceive hand motion or light. VA was measured as the number of ETDRS letters correctly read. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1465603|NCT00735943|Secondary|Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen|Participants were considered treatment naive when started on Macugen and without any previous drug or non drug treatment administered to the study eye. Participants were considered previously treated by any other therapy if received any other drug or non drug treatment to the study eye except Macugen.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1465787|NCT00734630|Primary|Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12|Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).|From baseline Visit 5 (Week 0) to Visit 10 (Week 12)||||mmHG||Standard Deviation|Mean
1465604|NCT00735943|Secondary|Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA|FFA was utilized to characterize the lesions as follows: Classic lesion: more than 50% of the lesion had a well-demarcated area of hyperfluorescence; minimally classic lesion: less than or equal to 50% of lesion had well-demarcated area of hyperfluorescence; occult lesion: lesion with no well demarcated borders. VA statuses were defined as: stabilization: loss of less than 15 letters in the BCVA; improvement: gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1465605|NCT00735943|Secondary|Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA in participants with early lesions was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||injections||Full Range|Median
1465606|NCT00735943|Secondary|Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||injections|||Number
1465607|NCT00735943|Secondary|Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA|Early lesions were defined by any 2 of the following criteria: occult lesion diagnosed on FFA; baseline VA of more than or equal to 54 ETDRS letters; lesion size of less than 2DA on FFA. Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Improvement in the VA was defined as gain of more than or equal to 15 letters in the BCVA.|12 months or last follow-up visit before study termination|Subgroup analysis was not performed as the study was terminated due to slow rate of recruitment.|||Percentage of participants|||Number
1465608|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters|A fluorescein angiogram provides information about the condition of the retina. Improvement in FFA parameters was defined as absence of progression of the lesion or decrease in the size of the lesion and absence of new lesions on FFA i.e. change in lesion size from baseline must be less than or equal to 0 disc area(DA) and no new lesions.|12 months or last follow-up visit before study termination|Due to small sample size, the analysis was not conducted.|||Percentage of participants|||Number
1465609|NCT00735943|Secondary|Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters|OCT, a noninvasive, noncontact, transpupillary imaging technology, was utilized to image retinal structures in vivo with a resolution of 10 to 17 microns. The anatomic layers within the retina, retinal thickness could be measured. Improvement in OCT parameters was defined as a reduction of more than or equal to 100 microns in the central macular thickness (Center subfield).|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique.|||Percentage of participants|||Number
1465610|NCT00735943|Secondary|Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy|Macugen monotherapy: referred to participants receiving Macugen in the study eye during the study that is (i.e.) participants without any concomitant drug treatment or nondrug treatment for the study eye during the study. Combination therapy: referred to participants receiving combination therapy in the study eye (during the study) i.e. participants with any concomitant drug treatment or nondrug treatment for the study eye during the study.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF analysis.|||Percentage of participants|||Number
1465611|NCT00735943|Primary|Median Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.|||injections||Full Range|Median
1465612|NCT00735943|Primary|Average Number of Injections to Achieve Stabilization of VA|Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first “stabilization in VA” (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.|12 months or last follow-up visit before study termination|FAS included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by LOCF technique. Analysis was conducted for those participants who received at least 1 injection of the study treatment in the study eye and achieved stabilization at the last follow-up.|||injections||Standard Deviation|Mean
1465625|NCT00735787|Secondary|Number of Subjects With Difficulties According to PHQ-9|Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).|Baseline and Weeks 2, 8, 16, and 28|"Analysis was based on the ITT subject population. Missing values were imputed as extremely difficult."|||subjects|||Number
1465613|NCT00735943|Primary|Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)|VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.|Baseline through 12 months or last follow-up visit before study termination|Full Analysis Set (FAS) included all participants who received at least 1 injection of the study treatment in the study eye during the study. Missing values were imputed by Last Observation Carried Forward (LOCF) technique.|||percentage of participants|||Number
1465614|NCT00735917|Secondary|Progression-Free Survival|Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.|Progression and survival status assessed every month, up to 2 years||||months||95% Confidence Interval|Median
1465615|NCT00735917|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a CR or PR to the date progression is documented. Estimated by the method of Kaplan-Meier.|From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years|No patients qualified for a confirmed response and therefore this endpoint was not analyzed.||||||
1465616|NCT00735917|Secondary|Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])|"A confirmed tumor response is defined to be a CR or PR noted as > the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) > > Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to <1.0 centimeters. >~> Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters."|Evaluated using the first 6 courses of treatment||||participants|||Number
1465617|NCT00735917|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.|Up to 2 years||||months||95% Confidence Interval|Median
1465618|NCT00735917|Primary|Six Month Survival|The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.|Up to 6 months||||percentage of patients||95% Confidence Interval|Number
1465619|NCT00735904|Secondary|Duration of Response (DR)|Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|DR was calculated for the subgroup of participants from the ITT set, with a confirmed objective tumor response (CR or PR).|||Months||95% Confidence Interval|Median
1465620|NCT00735904|Secondary|Progression Free Survival (PFS)|"Time in months from start of study treatment to the first documentation of objective tumor progression or to death due to any cause. PFS calculated as (Months) = (first event date minus first dose date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
1465621|NCT00735904|Secondary|Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline until death or assessed every 2 months (up to 28 days after the last dose)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
1465622|NCT00735904|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are those with disappearance of all target lesions. PR are those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.|Baseline until disease progression or discontinuation from the study due to any cause, assessed every 6 weeks during chemotherapy phase and every 8 weeks during single agent phase up to final study visit (Week 78)|Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1465623|NCT00735839|Primary|Number of Participants With Vaccine-related Serious Adverse Experiences|Vaccine-related adverse experiences are those determined by the investigator to be possibly, probably, or definitely vaccine-related.|Baseline (Day 1) to Day 84 postvaccination||||Participants|||Number
1465624|NCT00735839|Primary|Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level|Geometric mean fold rise is calculated as the natural logarithm of the ratio of Day 14 and baseline antibody titers.|Baseline (Day 1) to Day 14 postvaccination||||Ratio||95% Confidence Interval|Geometric Mean
1465739|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465626|NCT00735787|Secondary|Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)|The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
1465627|NCT00735787|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)|WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).|Baseline and Weeks 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
1465628|NCT00735787|Secondary|Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain|On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using LOCF.|||mm on scale||Standard Deviation|Mean
1465629|NCT00735787|Secondary|Number of Subjects Achieving a DLQI of 0|Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1465630|NCT00735787|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.|Baseline and Weeks 2, 8, 16, and 28|Analysis was based on the ITT subject population and performed using LOCF.|||units on a scale||Standard Deviation|Mean
1465631|NCT00735787|Secondary|Number of Subjects With PASI 100|Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1465632|NCT00735787|Secondary|Number of Subjects With PASI 90|Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1465633|NCT00735787|Secondary|Number of Subjects With PASI 75|Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1465634|NCT00735787|Secondary|Number of Subjects With Psoriasis Area and Severity Index (PASI) 50|Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).|Baseline and Weeks 16 and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1465635|NCT00735787|Secondary|Number of Subjects With PGA of Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using NRI.|||subjects|||Number
1465636|NCT00735787|Secondary|Number of Subjects With PGA of Clear or Almost Clear|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1465637|NCT00735787|Secondary|Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1465638|NCT00735787|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).|Baseline and Weeks 8, 16, and 28|Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.|||units on a scale||Standard Deviation|Mean
1465639|NCT00735787|Secondary|Number of Subjects With Marked Improvement in ESIF From Baseline|Number of subjects that achieved > 75% reduction from Baseline in ESIF|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1465640|NCT00735787|Secondary|Number of Subjects With Moderate Improvement in ESIF From Baseline|Number of subjects that achieved > 50% reduction from Baseline in ESIF.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).|||subjects|||Number
1465641|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Soles|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using the LOCF method.|||units on a scale||Standard Deviation|Mean
1465642|NCT00735787|Secondary|Mean Change From Baseline in ESIF for Palms|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28|Analysis was based on the ITT subject population and performed using the LOCF method.|||units on a scale||Standard Deviation|Mean
1465643|NCT00735787|Secondary|Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)|Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28|Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1465644|NCT00735787|Primary|Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16|Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.|Week 16|Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.|||subjects|||Number
1465645|NCT00735709|Secondary|Healthcare Resource Utilization as Assessed by the Health Economic Assessment Questionnaire.|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants' absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
1465646|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465647|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465648|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2 and 4|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465649|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465676|NCT00735696|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression, initiation of additional antitumor therapy is first reported, or death as a result of any cause. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions.|First dose up to 32.5 months|Participants who had tumor response. Two participants who had tumor response did not progress by the data cut-off date, therefore were censored for duration of response analysis.|||months||95% Confidence Interval|Median
1465650|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465651|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465652|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465653|NCT00735709|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at All Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 2, 4 and 8|"Full analysis set with available SF-36 Subscore data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465654|NCT00735709|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales at Each Week Assessed|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis|Baseline and Weeks 1, 4, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465655|NCT00735709|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465656|NCT00735709|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Each Week Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465705|NCT00735436|Secondary|Incidence and Severity of Central Nervous System (CNS) Hemorrhage|Incidence and severity of CNS hemorrhage|47 months|intent-to-treat|||participants|||Number
1465740|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465657|NCT00735709|Secondary|Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Each Week|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4, 6, and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465658|NCT00735709|Secondary|Percentage of Participants With a Sustained Response in HAM-D24 Total Score|A sustained response is defined as a ≥20% decrease from Baseline in HAM-D24 total score obtained at Week 1 and sustained through Week 7 and at least 50% decrease from Baseline at Week 8.|From Baseline through Week 8|Full analysis set|||percentage of participants|||Number
1465659|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Other Weeks Assessed|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Weeks 1, 2, 4 and 6|Full analysis set with available data at Week 1; Last observation carried forward was used for other time points.|||percentage of participants|||Number
1465660|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Other Weeks Assessed in Participants With a Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (symptoms severe). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥20 and with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465661|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Other Weeks Assessed|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Week 1; Last observation carried forward (LOCF) was used for other time points. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1465662|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available CGI-S data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465663|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2 and 6|"Full analysis set with available SDS Total Score data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465664|NCT00735709|Secondary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score at Other Weeks Assessed|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465665|NCT00735709|Secondary|Percentage of Participants in MADRS Remission at Week 8|Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
1465666|NCT00735709|Secondary|Change From Baseline in HAM-D24 Total Score at Week 8 in Participants With Baseline HAM-A Score ≥20|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. The Hamilton Anxiety Scale (HAM-A) is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (severe symptoms). LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥ 20. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465667|NCT00735709|Secondary|Percentage of Responders in HAM-D24 Total Score at Week 8|A responder is defined as a participant with a ≥50% decrease from Baseline in HAM-D24 total score. The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74, where a higher score indicates a greater depressive state.|Baseline and Week 8|Full analysis set; last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1465668|NCT00735709|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465669|NCT00735709|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465670|NCT00735709|Primary|Change From Baseline in the 24-item Hamilton Depression Scale Total Score At Week 8|The 24-item Hamilton Depression Scale (HAM-D24) is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 74 where a higher score indicates a greater depressive state. Least squares (LS) means are from a mixed model for repeated measurements (MMRM) with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|Baseline to Week 8|The full analysis set (FAS) included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465671|NCT00735696|Secondary|Maximum Concentration of Ramucirumab (Cmax)||Week 18 (Cycle 6), at 1-Hour Post End of Infusion|Participants who received any quantity of study medication and had evaluable concentration data at the specified time point.|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
1465672|NCT00735696|Secondary|Serum Anti-Ramucirumab Antibody Assessment|The number of participants who developed treatment emergent antibody responses to ramucirumab after baseline.|Week 15 (Cycle 5)|Participants who had Anti-Ramucirumab Antibody assessment at week 15 (cycle 5).|||participants|||Number
1465673|NCT00735696|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the first dose of study medication to the date of death from any cause. Participants who were alive at the end of the follow-up period or lost to follow-up were censored on the last date the patient was known to be alive.|First dose to death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Fourteen participants were censored."|||months||95% Confidence Interval|Median
1465674|NCT00735696|Secondary|Progression-free Survival (PFS)|"Defined as the time from date of first dose of study medication to the first documented disease progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.0), initiation of additional antitumor therapy was first reported or death due to any cause.~Participants who did not progress, who discontinued treatment for toxicity or a reason other than documented progression, or who were lost to follow-up before documented progression or death were censored at date of last tumor assessment. Participants who started new therapeutic anticancer treatment prior to documented progression or death were censored at date of last tumor assessment prior to new therapeutic anticancer therapy."|First dose to measured progressive disease or death due to any cause, up to 32.5 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."|||months||95% Confidence Interval|Median
1465675|NCT00735696|Secondary|Overall Survival (OS) at 1 Year|Data presented are the percentage of participants surviving at least 12 months after first dose of study medication.|First dose to 1 year|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1465706|NCT00735436|Secondary|Median Overall Survival (OS)|Time in months from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to date of death due to any cause, assessed up to 47 months|intent-to-treat|||months||95% Confidence Interval|Median
1465677|NCT00735696|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])|Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.|First dose to measured progressive disease or death due to any cause up to 32.5 months|Modified intent to treat population (mITT): All participants who received any quantity of study drug.|||percentage of participants||95% Confidence Interval|Number
1465678|NCT00735696|Secondary|Summary of Participants Reporting Adverse Events|Data presented are the number of participants who experienced ramucirumab related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of ramucirumab treatment, and any TEAE leading to dose modification ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.|Baseline up to 32.5 months|Safety Population: All participants who received any quantity of study drug.|||participants|||Number
1465679|NCT00735696|Primary|Percentage of Participants Who Are Progression-free (PFS) at 6 Months|Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.|6 months|"Modified intent to treat population (mITT): All participants who received any quantity of study drug.~Nine participants were censored."|||percentage of participants||95% Confidence Interval|Number
1465680|NCT00735670|Secondary|Depression Scale of the Patient Health Questionnaire (PHQ-9)|The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Higher total scores indicate more severe symptomatology, ranging from 0 (no symptoms) to 27 (most severe symptoms). Data in the tables begin with the overall mean for each group that includes all subjects, average across all assessment time points. Each subsequent row reports the mean and standard deviation of each time point by allocation, noting sample size for each group in the arm/group title given missing data in each time point after baseline.|Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks|Subjects with PHQ-9 data at any of the measurement time points (baseline, weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks) are included in the means reported for each time point. The sample size for each time point is given in the category title (e.g., 10Ven = 10 venlafaxine group or 11Plac = 11 placebo group) if it deviates from baseline.|||units on a scale||Standard Deviation|Mean
1465681|NCT00735670|Primary|16-Item Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR16)|The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a >50% change in scores on the QIDs from baseline to week 13 (end of treatment period).|Baseline and Week 13|Participants who completed the week 13 assessment.|||participants|||Number
1465682|NCT00735644|Other Pre-specified|Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.|Flavivirus (FV) positive was defined as anti-JE against homologous virus strain ≥10 l/dil or anti dengue against at least one serotype ≥10 l/dil. FV negative was defined as anti-JE against homologous virus strain <10 l/dil and anti-dengue against the 4 serotypes <10 l/dilution.|Day 0 (pre-vaccination)|Serological status of Flavivirus infection was assessed in the Per-protocol Analysis Set.|||Participants|||Number
1465683|NCT00735644|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.|Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite Lost, refuses ≥3 or most feeds/meals; and Irritability, inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set. A participant randomized to receive JE CV GPO MBP Lot 1 vaccine, received JE CV GPO MBP Lot 3. For safety analysis, the participant was analyzed according to the actual vaccine received.|||Participants|||Number
1465684|NCT00735644|Secondary|Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine|Anti Japanese encephalitis chimeric virus antibodies were measured using the PRNT50 assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the Per Protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
1465685|NCT00735644|Secondary|Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the PRNT50 assay. Seroprotection was defined as the proportion of subjects with a JE CV virus PRNT50 neutralizing antibody titer ≥10 1/dilution (dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE CV antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Participants|||Number
1465686|NCT00735644|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV|Anti-Japanese Encephalitis Chimeric Virus antibodies were measured using the 50% plaque reduction neutralization test (PRNT50) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE CV antigens were assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
1465687|NCT00735644|Primary|Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots|Anti-Japanese encephalitis chimeric virus vaccine antibodies were measured using the 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil, or participants with pre-vaccination titer ≥ 10 1/dil and 4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion to the JE CV vaccine antigens was assessed in the participants who were vaccinated and completed all study defined activities, Per-Protocol Analysis Set.|||Participants|||Number
1465688|NCT00735618|Primary|Differences Between Pre/Post ESAS Score|Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.|Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)|Analysis included all study participants.|||units on a scale||Standard Deviation|Mean
1465689|NCT00735553|Primary|To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)||4 months|Study prematurely terminated||||||
1465690|NCT00735475|Secondary|New Onsets of Chronic Illness|A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).|180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||participants|||Number
1465691|NCT00735475|Secondary|Serious Adverse Events||180 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||participants|||Number
1465692|NCT00735475|Secondary|Frequency and Intensity of Unsolicited Adverse Events (UAEs)|Abbreviation UAE stands for Unsolicited Adverse Event.|21 days after vaccination||||participants|||Number
1465693|NCT00735475|Secondary|Duration of Local and Systemic Solicited Symptoms||5 days after vaccination||||Days||Standard Deviation|Mean
1465694|NCT00735475|Secondary|Frequency and Intensity of Local and Systemic Solicited Symptoms||5 days after vaccination|Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.|||Percentage of Participants|||Number
1465695|NCT00735475|Primary|Percentage of Participants With Seroconversion 21 Days After the Study Vaccination|Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.|21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.|||Percentage of participants||95% Confidence Interval|Number
1465696|NCT00735475|Primary|Geometric Mean Titer 21 Days After the Study Vaccination||21 days after vaccination|Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.|||Titers||95% Confidence Interval|Geometric Mean
1465697|NCT00735462|Secondary|Number of Subjects With Any Treatment Related Adverse Reactions (AEs), Any Local Skin Reactions (LSRs), and Number of Subjects Who Took Rest Periods During the Treatment Period|"Treatment related defined as probably related or related by investigator. Local skin reactions (LSRs)were part of the treatment related adverse events and assessed by the investigators.~Rest periods defined as temporary interruption of dosing due to intolerable local skin reaction."|Up to 16 weeks|Analysis population was based on safety population which defined as for all subjects randomized and received at lease one dose. There was one subject who randomized to the 2.5% group but received one treatment kit of 3.75% imiq cream, so this subject was assigned to 3.75% for the safety analysis.|||participants|||Number
1465698|NCT00735462|Primary|Proportion of Subjects Achieving Complete Clearance of All Warts (Baseline and New) at the End of Study.|The complete clearance was defined as completely cleared all warts including baseline and newly emerged during the study at all anatomic areas.|Up to 16 weeks||||proportion of participants||95% Confidence Interval|Number
1465699|NCT00735449|Secondary|Number of Subjects With Adverse Events|Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).|Week 12|Safety population, which included all patients who started the study (randomized) and were treated.|||Participants|||Number
1465700|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 6|Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1465701|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 8 AM at Week 12|Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1465702|NCT00735449|Primary|Mean Intraocular Pressure (IOP) at 10 AM at Week 12|Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.|Week 12|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1465703|NCT00735449|Secondary|Mean Intraocular Pressure (IOP) at 10 AM at Week 6|Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.|Week 6|Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1465704|NCT00735436|Secondary|Incidence of Grade ≥ 4 Hematologic and ≥ Grade 3 Non-hematologic Toxicities|Incidence of grade ≥ 4 hematologic and ≥ grade 3 non-hematologic toxicities|47 months|intent-to-treat|||participants|||Number
1465707|NCT00735436|Secondary|Median Progression-free Survival (PFS)|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.|Time in months from the start of study treatment to the date of first progression according to modified Macdonald criteria or to death due to any cause, assessed up to 47 months|intent-to-treat|||months||95% Confidence Interval|Median
1465708|NCT00735436|Secondary|24-week Progression-free Survival (PFS)|The percentage of participants surviving 24 weeks from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.|24 weeks|intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1465709|NCT00735436|Primary|24-week Overall Survival|The percentage of participants surviving 24 weeks from the start of study treatment|24 weeks|intent-to-treat|||percentage of participants||95% Confidence Interval|Number
1465710|NCT00735397|Secondary|Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.|||Percent responders|||Number
1465711|NCT00735397|Secondary|Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.|Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)|Full Intent-to-treat population (ITT), defined as participants who provided informed consent for the OLE, received at least 1 dose of perampanel in the OLE, and had valid seizure data for overall, Complex Partial Plus Secondarily Generalized Seizures and Secondarily Generalized Seizures arm, respectively during the perampanel treatment duration.|||Percent change||Full Range|Median
1465712|NCT00735397|Primary|Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.|The safety analysis set (SAS) was defined as participants who provided informed consent for the OLE study, received at least 1 dose of perampanel in the OLE study, and had at least 1 postdose safety assessment in the OLE study.|||participants|||Number
1465713|NCT00735371|Secondary|Youth Quality of Life-Research Version (YQOL-R) Total Score|The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.|Baseline and 4 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1465714|NCT00735371|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|1, 2, 3 and 4 Weeks|FAS|||Participants|||Number
1465715|NCT00735371|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and 1, 2, 3 and 4 weeks|Full Analysis Set (FAS) is defined as all subjects who took at least one dose of study medication and had a valid Baseline and at least one post-Baseline follow-up assessment of the primary outcome measure (ADHD-RS-IV Total Score)|||Units on a scale||Standard Error|Least Squares Mean
1465716|NCT00735306|Secondary|One Year Overall Survival From Time of Diagnosis|One year survival from time of diagnosis for patients who completed this regimen|1 year||||participants|||Number
1465717|NCT00735306|Secondary|Number of Dose Limiting Toxicities||Within 30 days of completing radiation||||Events|||Number
1465719|NCT00735254|Primary|Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar|The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision.|1 year|study was not conducted per protocol, data was not collected, study terminated. Reported to IRB and closed study.||||||
1465720|NCT00735072|Primary|Week 24 Change in Percentage of CD8+ T Cells That Co-express CD38 and HLA DR (Week 24 %CD38+HLA-DR+ CD8+ T Cells Minus Baseline %CD38+HLA-DR+ CD8+ T Cells)||Week 24||||%CD38+ HLA-DR+ CD8+ T cells||Inter-Quartile Range|Median
1465721|NCT00735072|Secondary|Change in Gut-associated Lymphoid Tissue HIV RNA Level (UCSF Site Only)||Week 24|||||||
1465722|NCT00735072|Secondary|Change in Brachial Artery Flow-mediated Dilatation (UCSF Site Only)||Week 24|||||||
1465723|NCT00735072|Secondary|Change in Ultra-sensitive Plasma HIV RNA Level (Single Copy/ml Assay)||Week 24|||||||
1465724|NCT00735072|Secondary|Change in CD4+ T Cell Count||Week 24|||||||
1465725|NCT00735007|Secondary|The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.|Information on these outcomes is shown separately above, apart from information on the incidence of injection site related adverse events which is shown in the Adverse Events section|at the end of weeks 4, 8, and 12 of treatment|||||||
1465726|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 12 of treatment|Intention to treat population|||participants|||Number
1465727|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 8 of treatment|5 subjects with missing values|||participants|||Number
1465728|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4|Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating|at the end of week 4 of treatment|5 subjects with missing values|||participants|||Number
1465729|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 12 of treatment|Intention to treat population|||mm (on a scale)||Standard Deviation|Mean
1465730|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 8 of treatment|5 subjects with missing values|||mm (on a scale)||Standard Deviation|Mean
1465731|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4|Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)|at the end of week 4 of treatment|4 subjects with missing values|||mm (on a scale)||Standard Deviation|Mean
1465732|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 12 of treatment|21 subjects with missing values|||participants|||Number
1465733|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 8 of treatment|21 subjects with missing values|||participants|||Number
1465734|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.|at the end of week 4 of treatment|21 subjects with missing values|||participants|||Number
1465735|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465736|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 8 of treatment|5 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465737|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4|Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465738|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12|Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465774|NCT00734747|Secondary|Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject||6 months|Note: 1 of the 66 participants was not taking proton pump inhibitors (PPIs) at baseline, therefore they were excluded from the analysis of PPI use reduction.|||percentage of subjects||95% Confidence Interval|Number
1465741|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465742|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465743|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4|Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465744|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 12 of treatment|Intention to treat population|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465745|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 8 of treatment|6 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465746|NCT00735007|Secondary|Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4|Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.|at the end of week 4 of treatment|3 subjects with missing values|||MSTCQ Score (units on a scale)||Standard Deviation|Mean
1465747|NCT00735007|Primary|The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).|"RebiSmart was evaluated as very suitable or suitable; a little suitable; or not suitable at all for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer."|End of 12 week treatment period|4 subjects with missing values|||participants|||Number
1465748|NCT00734994|Primary|Safety and Tolerability|Number of patient treatments stopped due to safety concerns or treatment intolerability. All events below are grade 1/2 toxicity. No grade 3-5 toxicity was observed.|During Treatment Phase average 6 weeks||||Grade 1/2 event count (no grade 3+)|Participants||Number
1465749|NCT00734994|Secondary|Median Recurrence Free-survival|Time to first recurrence of cancer in the bladder.|Median follow-up 3.18 years|Entire cohort|||Months||95% Confidence Interval|Median
1465750|NCT00734968|Primary|Incidence of Post-operative UTI in Treatment Group|The incidence of UTI in the nitrofurantoin group was 17.6%.|6 weeks||||participants|||Number
1465751|NCT00734968|Primary|Incidence of Post-operative UTI in Placebo Group|The incidence of UTI in the placebo group was 32%.|6 weeks||||participants|||Number
1465752|NCT00734968|Primary|Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence|The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)|6 weeks||||participants|||Number
1465753|NCT00734929|Secondary|"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"|Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)|48 hour||||participants|||Number
1465754|NCT00734929|Secondary|Time to First Vomiting||48 h|The analysis population only includes participants who had vomiting and had a complete data set|||hours||Inter-Quartile Range|Median
1465755|NCT00734929|Secondary|Number of Vomiting Episodes||48 hours||||vomiting episodes||Inter-Quartile Range|Mean
1465756|NCT00734929|Secondary|Average Nausea Score|Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable|Post OP hours 0-2, 24 h, 48 h||||units on a scale||Inter-Quartile Range|Mean
1465757|NCT00734929|Secondary|Number of Participants With a Complete Response Rate|complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics.|24 hours Post OP, 48 hours Post OP||||participants|||Number
1465758|NCT00734929|Secondary|Use of Rescue Antiemetics (48 Hours)||48 hour||||participants|||Number
1465759|NCT00734929|Secondary|Use of Rescue Antiemetics (24 Hours)||24 h||||participants|||Number
1465760|NCT00734929|Secondary|Use of Rescue Antiemetics (Post OP)||Post OP (0 - 2 hours)||||participants|||Number
1465761|NCT00734929|Secondary|Incidence of Vomiting (24 Hours)|Any vomiting or retching|24 h|ITT analysis|||participants|||Number
1465762|NCT00734929|Secondary|Incidence of Vomiting (Post OP)||Post OP (0 - 2 hours)||||participants|||Number
1465763|NCT00734929|Secondary|Incidence of Nausea|operative procedure|Post operative procedure (OP) hours (0-2, 24, 48)||||participants|||Number
1465764|NCT00734929|Primary|Cumulative Incidence of Emesis|Any vomiting or retching|48 h|ITT analysis|||participants|||Number
1465775|NCT00734747|Secondary|Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test|Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure|6 months||||percentage of time pH <4.0||Standard Deviation|Mean
1465785|NCT00734656|Primary|Breath Alcohol|Breath Alcohol level|40 minutes after beginning drink|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||gr/dL||Standard Error|Mean
1465765|NCT00734851|Secondary|Comparison of RNA Expression Profile From Original Prostate Radical Prostatectomy Specimen Among Those With PSA Relapse at 2 and 3 Years as Compared to Those Without PSA Relapse at the Primary Endpoint.|Prospective collection of prostate tissue at the time of radical prostatectomy is routinely performed at Duke. These samples will be analyzed by laser capture microdissection (LCM) for genomic profiling by RNA expression analysis for all subjects with tissue available. The expression profiles of subjects who experience PSA recurrence after protocol therapy by the 24 month endpoint will be compared with the expression profiles of subjects without recurrence at this time point as an exploratory measure to predict aggressive prostate cancer and those subjects who are unlikely to benefit from this approach. Baseline prostate tumor biomarkers in the form of RNA expression profiles will be correlated with 2 year PFS in an exploratory analysis. The median bPFS of those with detectable biomarker expression is reported.|2 and 3 years|Due to the unavailability of tissue, this outcome was not performed.||||||
1465766|NCT00734851|Secondary|Change in Quality of Life (QoL) After 3 Month|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline and 3 months after completing radiotherapy. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 3 months|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.|||units on a scale||Full Range|Median
1465767|NCT00734851|Secondary|Change in Quality of Life (QoL) After 1 Year|A validated scale of prostate-cancer specific quality of life will be measured using the Expanded Prostate Cancer Index Composite (EPIC) short form survey. This survey is standardized into subscale, 4 of which were examined on this study. These subscales are the urinary irritative domain, urinary incontinence domain, bowel domain, and sexual function domain, each standardized on a scale of 0-100, where higher score indicate a higher level of QoL. The survey was performed at baseline, at 3 months after completing radiotherapy, at 12 months, and at 2 and 3 years of follow-up for a total of 5 possible surveys per patient. Due to a low number of completed surveys at the fourth and fifth time point, the difference between the 12 month time point and baseline is summarized. Negative values indicate a decrease in QoL, while positive numbers represent an increase.|baseline and 1 year|Only participant who adequately completed the sub-section of each questionnaire are included in the analysis population. Some participants did not answer a sufficient number of questions to adequately score a domain and therefore were not included.|||units on a scale||Full Range|Median
1465768|NCT00734851|Secondary|Metastasis-free Survival (MFS) Rates at 2 and 3 Years.|MFS is defined as the length of time between the date of start of treatment and the date of evidence of systemic disease on bone scan or cross sectional imaging or death, whichever occurs first.|2 and 3 years|This rate is not estimable as 0 patients had locally recurrent disease before being taken off study for biochemical progression.||||||
1465769|NCT00734851|Secondary|Rate of Local Recurrence at 2 and 3 Years|Local recurrence is defined as men with locally recurrent disease confirmed pathologically within the radiation field, and is estimated at 2 and 3 years.|24 months and 36 months||||percentage of participants|||Number
1465770|NCT00734851|Secondary|Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.|Percentage of participants surviving 24 and 36 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount or a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks. Please note: bPFS is identical to PFS but includes only PSA-based endpoints or death.|24 months and 36 months||||percentage of patients||95% Confidence Interval|Number
1465771|NCT00734851|Primary|The Rate of Progression Free Survival (PFS) at 24 Months|Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (PSA) value of 0.2 ng/mL or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, or evidence of clinical progression or initiation of systemic therapy for progressive disease.|2 years||||percentage of patients||95% Confidence Interval|Number
1465772|NCT00734799|Secondary|Nightmare Frequency|Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.|12 weeks after Baseline||||Nightmare frequency per night||Standard Error|Mean
1465773|NCT00734799|Primary|Insomnia Severity|Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.|12-weeks after Baseline|Intent to treat and completed were both reported. Data on completers reported here.|||ISI Score||Standard Error|Mean
1465776|NCT00734747|Primary|Serious Adverse Events (SAEs)|The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. “Treatment-related” events were conventionally defined as those which occurred in the first 30 days post-procedure. The SAEs presented here include all SAEs from the study, including one that occurred 35 days post-procedure (suicidal behavior). There was an interim review of early Serious Adverse Events (SAEs) after the first 24 patients. Protocol and device changes were then implemented, prior to the final 48 patients. Therefore, the SAEs are presented in two categories consisting of the first 24 patients and the final 48 patients.|6 months||||participants|||Number
1465777|NCT00734747|Primary|Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score|Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire, also known as Velanovich score. The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total. This questionnaire was administered while the subjects were not taking proton pump inhibitor (PPI) medication (i.e. off-PPI). Criterion for success was an improvement >= 50% compared to baseline, at six months post procedure in at least 53% of the subjects (53% is the lower boundary of the 95% confidence interval)|Six months||||percentage of total participants||95% Confidence Interval|Number
1465778|NCT00734734|Primary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.|0 to 3 days post-vaccination|Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.|||Number of participants|||Number
1465779|NCT00734734|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 0) and three weeks after FLUAD vaccination (day 21).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 21|Analysis was done using PP set.|||Percentage of participants||95% Confidence Interval|Number
1465780|NCT00734734|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 21).~The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is >2.0 (≥65 years)."|day 21|Analysis was done using PP set.|||Ratio||95% Confidence Interval|Geometric Mean
1465781|NCT00734734|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 21), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 21|Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1465782|NCT00734656|Secondary|Change in Serum 3a-androstanediol Glucuronide|Ratio of serum 3a-androstanediol drawn prior to alcohol administration (2-4 days after medication administration) compared to the baseline level prior to medication dose. The pharmacologic effect of dutasteride was measured by assay of serum 5a-androstan-3a,17b-diol,17-glucuronide (aka 3a-androstanediol glucuronide) as a biochemical measure of 5a-reductase enzyme inhibition. 3a-androstanediol glucuronide is the primary metabolic excretion product of 3a,5a-androstane neuroactive steroids. The|Baseline (pre medication administration) and 2-4 days post-medication (alcohol session)|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||ratio||Standard Error|Mean
1465783|NCT00734656|Primary|BAES Stimulation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES)Simulation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 stimulation related questions regarding effects of alcohol. Total BAES stimulation subscale score 0-70 with higher numbers indicating greater stimulating effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||units on a scale||Standard Error|Mean
1465784|NCT00734656|Primary|BAES Sedation Response, Average of 6 Time Points|Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score 0-70 with higher numbers indicating greater sedative effects of alcohol. [Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.]|40, 80, 120, 160, 210 and 240 minutes after start of drinking|Subjects who completed all 4 arms of study (e.g. completed each combination of dutasteride or placebo paired with 0.8 gr/kg ethanol or alcohol flavor mask)less 3 subjects removed during data cleaning due to pharmacy errors (n=2) or protocol deviation (n=1)resulted in 70 subjects completing each condition for analysis.|||units on a scale||Standard Error|Mean
1465788|NCT00734617|Primary|Continuous Abstinence From Smoking at Ten Weeks Post-quit|Continuous abstinence from the target quit date through the end of treatment (10 weeks) was assessed based on self reports of continuous abstinence (i.e., no lapses) that were confirmed by end-expired CO levels ≤ 10 ppm.|May 2009||||participants|||Number
1465789|NCT00734604|Secondary|"Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 4 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465790|NCT00734604|Secondary|"Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 3 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465791|NCT00734604|Secondary|"Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 2 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465792|NCT00734604|Secondary|"Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint"|Scores for Question 1 range from 0 (not at all) to 4 (extremely).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465793|NCT00734604|Secondary|Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score|Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1–8) and Confidence (items 9–14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465794|NCT00734604|Secondary|Number of Participants With at Least One Serious Adverse Event|Serious adverse events are listed in the Reported Adverse Event module.|baseline through 26 weeks (including two washout periods of 1 week each)||||participants|||Number
1465795|NCT00734604|Secondary|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint|EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).|8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465796|NCT00734604|Secondary|Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF|Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465797|NCT00734604|Secondary|Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF|Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465798|NCT00734604|Secondary|Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection||baseline, 8 weeks of each treatment||||proportion of days||Standard Deviation|Mean
1465799|NCT00734604|Secondary|Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)|Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465800|NCT00734604|Secondary|Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465801|NCT00734604|Secondary|Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465802|NCT00734604|Secondary|Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465803|NCT00734604|Primary|Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)|The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.|baseline, 8 weeks of each treatment||||units on a scale||Standard Deviation|Mean
1465821|NCT00734539|Secondary|Periventricular Leukomalacia||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1465822|NCT00734539|Secondary|Patent Ductus Arterious Requiring Surgical Ligation||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1465804|NCT00734591|Secondary|Rate of Primary Lung Cancer Diagnosis|The rate and rate ratio of lung cancer adjudicated as highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer) or likely (some information may have been missing for definite diagnosis) to be newly diagnosed primary lung cancer that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population|||Lung Cancer per 1000 PY||95% Confidence Interval|Number
1465805|NCT00734591|Secondary|Rate of All-cause Mortality|The rate and rate ratio of all-cause mortality that occurred anytime from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population|||Deaths per 1000 PY||95% Confidence Interval|Number
1465806|NCT00734591|Secondary|Rate of Primary Lung Cancer Mortality Among Former Smokers|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Subset of the entire study population who were former smokers.|||Deaths per 1000 PY||95% Confidence Interval|Number
1465807|NCT00734591|Primary|Rate of Primary Lung Cancer Mortality|Reported deaths from primary lung cancer were adjudicated and classified into 4 categories: highly likely (clinical, radiographic, and/or histological data consistent with primary lung cancer); likely (some information may have been missing for definite diagnosis); unlikely; insufficient information. Highly likely and likely cases used to report rate and rate ratio of primary lung cancer mortality. Includes events from the start of the original trial to the end of FUSE.|Baseline from original trial up to Year 2 of this study|Entire study population: all randomized participants (retrospective).|||Deaths per 1000 patient years (PY)||95% Confidence Interval|Number
1465808|NCT00734578|Secondary|Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF|Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses.|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
1465809|NCT00734578|Secondary|Change From Baseline in Before School Functioning Questionnaire (BSFQ) at Week 8 - LOCF|This scale was designed to assess symptoms of ADHD that typically occur in the morning. The BSFQ consists of two components. The first, a 20-item scale with ratings from 0 (none) to 3 (severe) with a range of 0-60 followed by two questions answered with duration of time (in minutes). The second, a 14-item scale with ratings from 0 (no) to 2 (a lot) with a range of 0-28. The results reported here are from the 20-item scale. Lower scores are better.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1465810|NCT00734578|Secondary|Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Week 8 - LOCF|The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1465811|NCT00734578|Secondary|Percentage of Participants With Improvement on Parent Global Assessment (PGA) at Week 8 - LOCF|Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and week 8|FAS|||Percent of participants|||Number
1465812|NCT00734578|Secondary|Change From Baseline in Conners' Global Index - Parent (CGI-P) Total Score at Week 8 - LOCF: Evening Assessment (Before Bedtime)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 30.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1465813|NCT00734578|Secondary|Change From Baseline in Conners’ Global Index – Parent (CGI-P) Total Score at Week 8 - LOCF: Morning Assessment (Before School)|The index contains 10 items. Each item on the scale is scored from a range of 0 (reflecting never, seldom) to 3 (reflecting very often, very frequent) with total scores ranging from 0 to 30.|Baseline and weekly up to 8 weeks|FAS|||Units on a scale||Standard Deviation|Mean
1465814|NCT00734578|Secondary|Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF|CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
1465815|NCT00734578|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 8 - LOCF|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Baseline and weekly up to 8 weeks|FAS|||Percent of participants|||Number
1465816|NCT00734578|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF)|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.|Baseline and weekly up to 8 weeks|Full Analysis Set (FAS) which includes all subjects who received at least 1 dose of any study drug during this study.|||Units on a scale||Standard Deviation|Mean
1465817|NCT00734539|Secondary|Intraventricular Hemorrhage|Grade 3 or 4|prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1465818|NCT00734539|Secondary|Positive Bacterial Infection From a Sterile Site||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1465819|NCT00734539|Secondary|Length of Hospitalization||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||days||Inter-Quartile Range|Median
1465820|NCT00734539|Secondary|Retinopathy of Prematurity Requiring Laser Surgery||prior to hospital discharge, up to 15 ½ months|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1465828|NCT00734539|Primary|Death or Candidiasis|"The primary endpoint for the study is death or candidiasis.~Death prior to study day 49.~Candidiasis prior to study day 49~Definite: isolation of Candida from normally sterile body fluid (blood, CSF, urine [obtained via sterile catheterization or suprapubic tap], peritoneal fluid).~Probable:~i. > 5 days of consecutive antifungal therapy~AND both:~ii. Thrombocytopenia <150,000/mm3 iii. Positive Candida culture from nonsterile site (ETS, bag urine)"|study day 49|Modified intent-to-treat; only subjects who received at least one dose of study drug.|||participants|||Number
1465829|NCT00734500|Secondary|Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Participants with Adverse events were collected during the study drug administration phase up to 10 days after last dose of study drug.|During and up to 10 days after last dose of study drug.||||participants|||Number
1465830|NCT00734500|Primary|The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.|Area under the curve at steady state|5 days||||µg*h/mL||Full Range|Median
1465831|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks|Data on any new cardiovascular (CV) event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with adjudicated CV events is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.|||participants|||Number
1465832|NCT00734474|Other Pre-specified|Number of Participants With Adjudicated Pancreatitis at 104 Weeks|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants.|||participants|||Number
1465833|NCT00734474|Secondary|Antibodies to LY2189265|The number of participants with postbaseline detection of treatment-emergent antidrug LY2189265 antibodies (ADA) is summarized.|Baseline through 104 weeks|All randomized participants in the LY2189265 arms who had evaluable ADA data. If there were no data after the date of randomization, the endpoint was considered missing.|||participants|||Number
1465834|NCT00734474|Secondary|Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve|Pharmacokinetic (PK) parameter estimates from LY2189265 concentration data were obtained using a 2-compartment population PK model with first order absorption. Area under the plasma-concentration curve from 0 to 168 hours, steady state (AUC0-168h, ss) of LY2189265 is summarized.|Baseline through 52 weeks|Randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) who had blood samples collected for PK assessments.|||nanograms times hours per milliliter||Standard Deviation|Mean
1465835|NCT00734474|Secondary|Resource Utilization|The number of visits to the emergency room (ER) is summarized cumulatively.|Baseline through 52 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.|||events|||Number
1465836|NCT00734474|Secondary|Participant-reported Outcomes, EQ-5D|The EQ-5D questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts. The first part allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale of 1-3 (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the questionnaire consists of a 100-millimeter visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable EQ-5D data. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
1465837|NCT00734474|Secondary|Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)|The Impact of Weight on Quality of Life-Lite (IWQoL-Lite questionnaire) is an obesity-specific, 31-item questionnaire designed to measure the impact of weight on participants’ quality of life. Items are scored on a 5-point numeric rating scale where 5 = “always true” and 1 = “never true”. Items are summed into 6 scales (physical function [11 items], self-esteem [7 items], sexual life [4 items], public distress [5 items], work [4 items], and total score [31 items]) based on the average for the valid responses on that scale multiplied by the number of items on that scale (rounded to the nearest whole integer). Higher scores indicate lower levels of functioning (negative effects). Scores are linearly transformed to a 0 to 100 scale.|Baseline, 52 weeks, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable IWQoL-Lite data. If there were no data after the date of randomization, the endpoint was considered missing.|||units on a scale||Standard Deviation|Mean
1465838|NCT00734474|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable ECG data. If there were no data after the date of randomization, the endpoint was considered missing.|||milliseconds (msec)||Standard Error|Least Squares Mean
1465839|NCT00734474|Secondary|Change From Baseline in Blood Pressure|Sitting and standing systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable SBP and DBP data. If there were no data after the date of randomization, the endpoint was considered missing.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
1465840|NCT00734474|Secondary|Change From Baseline in Pulse Rate|Sitting and standing pulse rate were measured. Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable pulse data. If there were no data after the date of randomization, the endpoint was considered missing.|||beats per minute (bpm)||Standard Error|Least Squares Mean
1465841|NCT00734474|Secondary|Change From Baseline in Blood Pressure at Dose Decision Point|Sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at the dose decision point. Change from baseline in DBP was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the time of the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting SBP and DBP data.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1465842|NCT00734474|Secondary|Change From Baseline in Pulse Rate at Dose Decision Point|Sitting pulse rate was measured at the time that the dose decision was made (dose decision point). Change from baseline in pulse rate was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable sitting pulse rate data.|||beats per minute (bpm)||Standard Deviation|Mean
1465843|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Lipid Tests|The number of participants with treatment-emergent abnormal lipid test (cholesterol, high density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], and triglycerides [TG]) results (defined as lipid test abnormalities that first occurred after baseline) is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1465844|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1465845|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR) .|Baseline through 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1465846|NCT00734474|Secondary|Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks|The number of participants with treatment-emergent abnormal laboratory results (defined as abnormalities that first occur after baseline) was summarized cumulatively for alkaline phosphatase, alanine aminotransferase or serum glutamic pyruvic transaminase (ALT/SGPT), amylase (pancreatic and total), aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST/SGOT), basophils, bilirubin (direct and total), calcitonin, chloride, creatine phosphokinase (CPK), creatinine, creatinine clearance, eosinophils, erythrocytes, gamma glutamyltransferase (GGT), hematocrit, hemoglobin, leukocytes, lipase, lymphocytes, mean cell hemoglobin concentration (MCHC), mean cell volume (MCV), monocytes, neutrophils, platelets, potassium, sodium, urea nitrogen, and urine microalbumin-to-creatinine ratio (UMCR).|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms with baseline value not in the specified direction of treatment-emergent abnormality and at least 1 postbaseline result.|||participants|||Number
1465847|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 104 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms.|||participants|||Number
1465848|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 52 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|All randomized participants in the LY2189265 and active comparator (Sitagliptin) arms.|||participants|||Number
1465849|NCT00734474|Secondary|Number of Participants With Treatment-emergent Adverse Events at 26 Weeks|A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with 1 or more TEAEs is summarized cumulatively. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||participants|||Number
1465850|NCT00734474|Secondary|Beta Cell Function and Insulin Sensitivity (HOMA2)|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-%B and HOMA2-%S were set at 100%. Least squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point and who had evaluable HOMA2 data. If there were no data after the date of randomization, the endpoint was considered missing.|||HOMA2-%||Standard Error|Least Squares Mean
1465851|NCT00734474|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The 1-year adjusted rate of HE is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||episodes per participant per year||Standard Deviation|Mean
1465852|NCT00734474|Secondary|Incidence of Hypoglycemic Episodes|Hypoglycemic episodes (HE) were classified as severe (defined as episodes requiring assistance from another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia and has a plasma glucose level of ≤3.9 millimoles per liter [mmol/L]), asymptomatic (defined as episodes not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤3.9 mmol/L), nocturnal (defined as any episode that occurred between bedtime and waking), or probable symptomatic (defined as episodes during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of participants with self-reported hypoglycemic events is summarized cumulatively.|Baseline through 26 and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms.|||participants|||Number
1465853|NCT00734474|Secondary|Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%|The percentage of participants achieving HbA1c levels <7.0% and ≤6.5% was analyzed using a logistic regression model and last observation carried forward (LOCF) imputation with baseline, country, and treatment as factors included in the model.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
1465854|NCT00734474|Secondary|Waist Circumference Change From Baseline|Least squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable waist circumference data. If there were no data after the date of randomization, the endpoint was considered missing.|||centimeters (cm)||Standard Error|Least Squares Mean
1465855|NCT00734474|Secondary|Durability of Change From Baseline Body Weight|Durability of effect on body weight was assessed by comparing the differences in mean change from baseline in body weight at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline body weight data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable body weight data. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1465891|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 2 Months|Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1465856|NCT00734474|Secondary|Body Weight Change From Baseline|Least squares (LS) means of change from baseline body weight were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable body weight data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
1465857|NCT00734474|Secondary|Change From Baseline in Body Weight at Dose Decision Point|Change from baseline in body weight was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable body weight data.|||kilograms (kg)||Standard Deviation|Mean
1465858|NCT00734474|Secondary|Fasting Insulin Change From Baseline|Least squares (LS) means of change from baseline fasting insulin data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable fasting insulin data. If there were no data after the date of randomization, the endpoint was considered missing.|||picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
1465859|NCT00734474|Secondary|Fasting Blood Glucose Change From Baseline|Least squares (LS) means of change from baseline were calculated using mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26, 52, and 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable fasting plasma glucose data. If there were no data after the date of randomization, the endpoint was considered missing.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
1465860|NCT00734474|Secondary|Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Durability of effect on HbA1c was assessed by comparing the differences in mean change from baseline in HbA1c at 1 time point versus an earlier time point. Least squares (LS) means of change from baseline HbA1c data were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 13, 26, 52, and 104 weeks|All participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms randomized after the dose decision point who had evaluable HbA1c data. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1465861|NCT00734474|Secondary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 26 weeks, 104 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and comparator (Sitagliptin, Placebo/Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1465862|NCT00734474|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point|Change from baseline in HbA1c was 1 of the 4 measures included in the clinical utility index (CUI) used to evaluate the dose decision. The maximum duration of exposure to LY2189265, Sitagliptin, or Placebo (across all treatment arms) at the decision point was 27.4 weeks.|Baseline up to 27.4 weeks|All participants randomized before the dose decision point who had evaluable HbA1c data.|||percentage of HbA1c||Standard Deviation|Mean
1465863|NCT00734474|Primary|Glycosylated Hemoglobin (HbA1c) Change From Baseline|Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.|Baseline, 52 weeks|All randomized participants in the selected (1.5 mg, 0.75 mg LY2189265) and active comparator (Sitagliptin) arms who had evaluable HbA1c data. Last observation carried forward was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
1465864|NCT00734409|Secondary|Mean Days on Mechanical Ventilation|The mean number of days that the patients were on mechanical ventilation.|ICU stay- through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||Days||Standard Deviation|Mean
1465865|NCT00734409|Secondary|Unplanned Self-device Removal Events|The number of unplanned self-device removal events that took place during the study period.|ICU stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||Event|||Number
1465866|NCT00734409|Primary|Mean Sedative Use|The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.|Intensive Care Unit (ICU) stay through discharge|All patients who met eligibility requirements, consented for the trial, and were randomized were included in the analysis.|||ml/hour||Standard Deviation|Mean
1465867|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 11 Months|Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|11 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 9 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 9 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465868|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 10 Months|Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465869|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 9 Months|Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|9 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 8 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465870|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 8 Months|Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465871|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 7 Months|Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|7 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 5 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465872|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 6 Months|Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465873|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 5 Months|Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|5 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465874|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 4 Months|Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 4 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465875|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 3 Months|Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|3 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465876|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 2 Months|Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 1 subject because either the subjects missed a visit or chose not to stop therapy|||cells/mm3||Full Range|Mean
1465877|NCT00734344|Primary|Mean CD4 Count Between Treatment Groups at 1 Months|Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410–1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent).|1 month after baseline||||cells/mm3||Full Range|Mean
1465878|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 14 Months|The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1465879|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 12 Months|The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1465880|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 10 Months|The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1465881|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 8 Months|The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1465919|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1508308|NCT00411216|Primary|Subjective Complaints: (All Pre- and Post-intervention):|questionnaire|pre-intervention, 2 weeks, 4 weeks and at discharge|||||||
1465882|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 6 Months|The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1465883|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 4 Months|The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter).|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||count per microliter||Full Range|Mean
1465884|NCT00734344|Primary|Mean Platelet Count Between Treatment Groups at 2 Months|The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter).|2 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm|||count per microliter||Full Range|Mean
1465885|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 14 Months|Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1465886|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 12 Months|Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1465887|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 10 Months|Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1465888|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 8 Months|Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1465889|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 6 Months|Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1465890|NCT00734344|Primary|Mean Hematocrit Between Treatment Groups at 4 Months|Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women.|4 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||percentage||Full Range|Mean
1465920|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465892|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 14 Months|Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|14 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 8 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 6 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1465893|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 12 Months|Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|12 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 6 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 5 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1465894|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 10 Months|Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|10 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 7 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 7 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1465895|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 8 Months|Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|8 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 3 subjects because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1465896|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 6 Months|Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|6 months after baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 4 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1465897|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 4 Months|Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|4 months post baseline|In the Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy; in the Efavirenz plus Tuvada arm, there was no date for 3 subjects because either the subjects missed a visit or chose not to stop therapy|||white blood cells per microliter (mcL).||Full Range|Mean
1465898|NCT00734344|Primary|Mean White Blood Cell Count Between Treatment Groups at 2 Months|Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL).|baseline to 2 months|Raltegravir plus Truvada arm, there was no data for 1 subject because either the subject missed a visit or chose not to stop therapy.|||white blood cells per microliter (mcL).||Full Range|Mean
1465899|NCT00734305|Secondary|To Determine the Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The AUC is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
1465900|NCT00734305|Secondary|To Determine the Pharmacokinetic and Immunogenicity Parameters of MM-121|"Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) is presented and was calculated usig Non-compartmental analysis (NCA). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (3.2 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, 40/20 mg/kg).~Immunogenicity data is not available."|At Cycle 1, Week 1 pre-treatment, at the end of the infusion, and 2, 4, 8, 24, 48 and 72 hours after starting the infusion; pre-dose collections on Cycle 1, Week 2 and Cycle 2, Week 1 for all patients|All patients. NOTE: There are 22 patients included in the final cohort (4 patients in dose escalation portion Cohort 6 + 18 patients in Expansion Cohort), as PK analysis was performed per dose level and not per cohort. Cohort 6 and the Expansion Cohort were administered the same dose, and therefore the analysis reflects all 22 patients.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1465901|NCT00734305|Secondary|To Describe the Dose-limiting Toxicity of MM-121 as a Monotherapy|To establish the safety of escalating doses of MM-121 administered as a monotherapy in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 47 weeks||||participants reporting DLTs|||Number
1465902|NCT00734305|Primary|Determine the Maximum Tolerated Dose Dependent on Reports of Dose-limiting Toxicities|Using a 3+3 dose escalation model, the maximum tolerated dose was determined by assessing dose-limiting toxicities in each cohort from cohort 1-6. Cohort 1 began at 3.2 mg/kg IV QW and the dose escalated in separate cohorts from 6 mg/kg IV QW, 10 mg/kg IV QW, 15 mg/kg IV QW, 20 mg/kg IV QW, to the highest scheduled testing dose at 40 mg/kg one-time loading dose on cycle 1, week 1 followed by 20 mg/kg IV QW maintenance doses. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in the expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose and was used to open the expansion cohort.|From date of first dose to 30 days after termination, the longest 47 weeks|All participants in the 6 cohorts of dose escalation|||mg/kg|||Number
1465903|NCT00734305|Primary|Objective Response Rate and Duration|"To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response is defined as a >20% decrease in tumor burden from baseline and a Complete Response is defined as complete disappearance of tumor burden from baseline. Duration of response is defined as the length of time in weeks from observation of response until progression.~NOTE: because no patients experienced an objective response as shown below, duration of response is not presented. No duration of response could be measured."|Time from first dose to date of progression, with a median of 7.1 weeks||||participants with objective response|||Number
1465904|NCT00734214|Primary|Hyponatremia|Plasma sodium less than 135 mmol/L|during the study intervention|Intention to treat analysis|||participants|||Number
1465905|NCT00734214|Secondary|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.||During the treatment and follow-up period|||||||
1465906|NCT00734214|Primary|Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)||During the treatment and follow-up period.|||||||
1465907|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-Positive with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
1465908|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
1465909|NCT00734162|Secondary|Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set with abnormal ALT at baseline were analyzed.|||percentage of participants|||Number
1465910|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
1465911|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
1465912|NCT00734162|Secondary|Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Baseline; Weeks 48, 72, 96, 144, and 192|Participants in the Full Analysis Set who were HBeAg-positive at baseline were analyzed.|||percentage of participants|||Number
1465913|NCT00734162|Secondary|Number of Participants With Changes in Drug-Resistant Mutations During the Study|The number of participants with changes in drug-resistant mutations during the study was summarized.|Baseline through Week 192|Participants with HBV DNA ≥ 400 copies/mL, with confirmed virologic breakthrough (defined as 2 consecutive increases in HBV DNA of at least 10-fold from nadir, or confirmed values ≥ 400 copies/mL after being < 400 copies/mL while on study medication), or subjects who discontinued early (after Week 24 with HBV DNA ≥ 400 copies/mL) were analyzed.|||participants|||Number
1465914|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465915|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465916|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465917|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465918|NCT00734162|Secondary|Change From Baseline in Z-score for Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465921|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465922|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465923|NCT00734162|Secondary|Change From Baseline in Z-score for Spine BMD at Week 48|To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject’s recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject’s recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||z-score||Standard Deviation|Mean
1465924|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465925|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465926|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465927|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465928|NCT00734162|Secondary|Percent Change From Baseline in Whole Body BMD at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465929|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 192|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 192|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465930|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 144|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465931|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465932|NCT00734162|Secondary|Percent Change From Baseline in Spine BMD at Week 72|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 72|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465933|NCT00734162|Secondary|Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48|Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
1465934|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 72, 96, 144, and 192|Safety Analysis Set|||percentage of participants|||Number
1465935|NCT00734162|Secondary|Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192|The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis).|Baseline; Weeks 48, 96, 144, and 192|Safety Analysis Set|||percentage of participants|||Number
1465936|NCT00734162|Secondary|Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192|HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1465937|NCT00734162|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F.|Baseline; Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1465938|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1465939|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1465940|NCT00734162|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 72, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1465941|NCT00734162|Secondary|Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192|Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method.|Weeks 48, 96, 144, and 192|Full Analysis Set|||percentage of participants|||Number
1465942|NCT00734162|Primary|Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72|"Data were summarized by treatment and age group (grouped by baseline age for analysis).~In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192."|Baseline to Week 72|Safety Analysis Set: participants who received at least one dose of study drug.|||percentage of participants|||Number
1465943|NCT00734162|Primary|Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72|"The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.~In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included."|Week 72|Full Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
1465944|NCT00734149|Secondary|Median Duration of Response|Duration of response is measured from date of first confirmed response until date of disease progression.|up to 4 years||||months||95% Confidence Interval|Median
1465945|NCT00734149|Secondary|Number of Patients With Any Grade or Severe Adverse Event|Number of patients with any grade or severe, defined as ≥ grade 3 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0, adverse events as a measure of safety|At any time during the study and up to 30 days after stopping the study drug||||participants|||Number
1465946|NCT00734149|Primary|Response|Overall response rate equals complete response and partial response per Southwest Oncology Group Criteria. Measurable, quantifiable protein criteria must be present. Acceptable protein criteria are quantitative immunoglobulin IgG, IgA, IgD, IgE or IgM and/or urine M-component (Bence-Jones protein). If both are present, the quantitative immunoglobulin will be followed for response. Complete Remission: The absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-components on electrophoresis as by immunofixation studies. There must also be no evidence of increasing anemia. Partial Remission: A 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein). Stable/No Remission): A <50% reduction I nthe quantitative immunoglobulin, or if the patient has light-chain disease only, a <50% reduction in the urine M-component (Bence-Jones protein.|6 weeks following completion of treatment||||participants|||Number
1465947|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 4 Weeks of Treatment|"Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units of scale||Standard Deviation|Mean
1465948|NCT00734097|Secondary|Change in Severity of Acid Regurgitation After 8 Weeks of Treatment|"Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
1465949|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 4 Weeks of Treatment|"Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units of scale||Standard Deviation|Mean
1465950|NCT00734097|Secondary|Change in Severity of Epigastric Pain After 8 Weeks of Treatment|"Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
1465951|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 8 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe)."|At Baseline and 8 weeks||||Days per week with pain||Standard Deviation|Mean
1465989|NCT00733993|Primary|Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects|Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.|Immediately after dose||||units on a scale||Standard Error|Mean
1465952|NCT00734097|Secondary|Change in Frequency of Epigastric Pain After 4 Weeks of Treatment|"Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Days per week with pain||Standard Deviation|Mean
1465953|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks.||||Days per week with symptoms||Standard Deviation|Mean
1465954|NCT00734097|Secondary|Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.|"Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.~Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks.||||Days per week with symptoms||Standard Deviation|Mean
1465955|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment|"Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 4 weeks||||Units on scale||Standard Deviation|Mean
1465956|NCT00734097|Secondary|Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment|"Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from None to Severe.~Four dimensions are defined for the RDQ – heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe)."|At Baseline and 8 weeks||||Units of scale||Standard Deviation|Mean
1465957|NCT00734097|Secondary|Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment|Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.|At Baseline and 4 weeks||||Days per week with symptoms||Standard Deviation|Mean
1465958|NCT00734097|Primary|Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment|Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline|At Baseline and 8 weeks||||Days per week with symptoms||Standard Deviation|Mean
1465959|NCT00734071|Secondary|Health Care Resource Utilization as Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set with available data at Baseline (139 and 136 patients) and at Week 8 (122 and 131 patients).|||participants|||Number
1465960|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Mental Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The mental health sub-score assesses general mental health (psychological distress and well-being) and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465961|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Emotional Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465962|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Vitality Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465963|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The general health sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1468204|NCT00719849|Secondary|Incidence of Clinically Significant Infections at 6 Months|Number of participants with clinically significant infections at 6 months|6 months post transplant||||Participants|||Count of Participants
1465964|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Bodily Pain Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The bodily pain sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465965|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Role-Physical Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The role-physical subscale assesses limitations in usual role activities because of physical health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465966|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Functioning Subscore at Each Week Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The physical functioning subscale assesses limitations in physical activities because of health problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465967|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Other Weeks Assessed|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 2 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465968|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Depression Subscale at Each Week Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 4 and 8|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465969|NCT00734071|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness at Each Week Assessed|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465970|NCT00734071|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set; Last observation carried forward was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1465971|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466116|NCT00733330|Secondary|To Compare the Change From 6-12 Weeks & 5 Years on Long Leg Alignment.|An independent radiographer will observe and record alignment|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1465972|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; Last observation carried forward was used; n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1465973|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means and P-values were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465974|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465975|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Other Weeks Assessed|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1 and 4|"The Full Analysis Set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465976|NCT00734071|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Weeks 1, 2, 4 and 6.|"The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1465977|NCT00734071|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Social Functioning Subscore at Week 8|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. The sub-score scale ranges from 0 (best) - 100 (worst). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465978|NCT00734071|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465979|NCT00734071|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the Hamilton Anxiety Scale (HAM-A) total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; Last observation carried forward was used.|||percentage of participants|||Number
1466024|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
1465980|NCT00734071|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465981|NCT00734071|Secondary|Clinical Global Impression Scale-Global Improvement at Week 8|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465982|NCT00734071|Secondary|Change From Baseline in the Hospital Anxiety and Depression (HAD) Anxiety Subscale at Week 8|The Hospital Anxiety and Depression (HAD) Anxiety sub-scale consists of 7 items that are assessed by a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). The anxiety subscale determines a state of generalized anxiety including anxious mood, restlessness, anxious thoughts and panic attacks. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465983|NCT00734071|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM).|Baseline to Week 8|The Full Analysis Set included all patients who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1465984|NCT00734032|Secondary|Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 1, Week 2 and Follow-up) assessment values minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The log was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken change from Baseline on that log original value, calculated as log (post-Baseline [Week 1, Week 2 and Follow-up] values) minus log (Baseline value).|Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7)|FAS Population with LOCF analysis.|||Log(millimole per milliliter per minute)||Geometric Coefficient of Variation|Geometric Mean
1465985|NCT00734032|Secondary|Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Percentage inhibition of Lp-PLA2 activity relative to a Baseline value was calculated as: 100 multiplied by (post-Baseline values (Week 1, 2, 4 and Follow-up–Baseline value) divided by [Baseline value]).|Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7)|FAS Population with LOCF analysis.|||Percent inhibiton of Lp-PLA2 activity||Standard Deviation|Mean
1465986|NCT00734032|Primary|Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity|Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value [week 4]) minus log (Baseline value).|Baseline (Week 0, Visit 2) and Week 4|Full Analysis Set (FAS) Population was defined as all randomized participants who received at least one dose of study medication during treatment period and who had at least one evaluable assessment of Lp-PLA2 activity after randomization. Missing values during treatment period, except for Baseline were imputed by last observed response (LOCF).|||Log(millimole per milliliter per minute)||Geometric Coefficient of Variation|Geometric Mean
1465987|NCT00733993|Secondary|Saliva Caffeine and Paraxanthine Levels|"Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.~Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls."|30 minutes prior to dose, 30/90/150 minutes post dose.|Assessment was not performed for amphetamine intervention|||ng/mL||Standard Error|Mean
1465988|NCT00733993|Secondary|Probabalistic Feedback Selection Task|Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.|75 minutes after dose||||accuracy||Standard Error|Mean
1470692|NCT00703391|Secondary|Quantitative Sputum Bacteriology|Number of patients with an increase in bacteriological count from Day -1 to Day 15|Pre-dose day -1 to post-dose on day 15||||Participants|||Number
1465990|NCT00733993|Primary|Addiction Research Center Inventory Subjective Rating of Drug Effects|"Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items.~Includes the following subscales:~Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and intellectual efficiacy (+4 to +9, higher scores = more energy)"|Immediately after dose||||units on a scale||Standard Error|Mean
1465991|NCT00733993|Primary|Heart Rate|Sitting heart rate|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours||||Beats per minute||Standard Error|Mean
1465992|NCT00733993|Primary|Systolic and Diastolic Blood Pressure|Sitting Blood Pressure|Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours||||mmHg||Standard Error|Mean
1465993|NCT00733993|Primary|Visual Analog Scale Subjective Rating of Drug Effects|Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.|Immediately after dose||||units on a scale||Standard Error|Mean
1465994|NCT00733980|Secondary|Discontinuation-Emergent Signs and Symptoms|The discontinuation signs and symptoms scale consisted of 43 signs and symptoms, scored as ‘new symptom (NS)’, ‘old symptom (OS) but worse’, ‘OS but improved’ or ‘ symptom not present/old symptom but unchanged’. The total number of new signs and symptoms, old symptoms but worse, and old symptoms but improved was calculated for each participant. The number of participants with Discontinuation-Emergent Signs and Symptoms were reported. The visits were at Week 6 Visit, 7-D FU and 28-D FU visit.|At Week 6, 7-day (D) FU and 28-D FU|All subject population.|||Participants|||Count of Participants
1465995|NCT00733980|Secondary|Number of Participants With Hormonal Data of PCI|The number of participants with hormone values outside the CRI were reported. The hormone data was analyzed for parameters like Cortisol total, Dehydroepiandrosterone, Thyroxine, free, and thyroid stimulating hormone (TSH) .|up to Week 10|All subject population.|||Participants|||Count of Participants
1465996|NCT00733980|Secondary|Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range|The number of participants with clinical chemistry values outside the clinical importance range (CIR) were reported. The values for chemistry parameters outside CRI were reported for Alanine amino transferase (ALT), Aspartate amino transferase, total bilirubin, calcium, Creatine Kinase, carbon dioxide (CO^2) content/bicarbonate (BC), glucose and potassium were reported.|Upto Week 10|All subject population.|||Participants|||Count of Participants
1465997|NCT00733980|Secondary|Number of Participants With Abnormal Hematology Values of PCI-Platelet|Number of participants with abnormal Hematology values of PCI were reported. The abnormal values were reported only for platelet, diagnosed at Week 6 or Early withdrawal visit.|Upto 28-day FU|All Subject population|||Participants|||Count of Participants
1465998|NCT00733980|Secondary|Number of Participants With Abnormal Electrocardiograph (ECG) Values|The 12-lead ECG, were obtained at each time-point during the study using an ECG machine. The number of participants with ECG abnormal values were reported.|Randomization (Week 0), Week 4, Week 6 and 28 Day follow-up|All subject population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1465999|NCT00733980|Secondary|Number of Participants With Abnormal Urinalysis Data|Urinalysis included analysis for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine Leukocyte Esterase test (LET) via dipstick analysis. The number of participants with abnormal urinalysis data were reported. In the dipstick test the levels for urine bilirubin, urine occult blood, urine glucose, urine ketones, urine nitrite, urine proteins and urine LET with results of trace, negative, positive,1+=slightly positive, 2+=positive, 3+=high positive were reported.|Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU)|All subject population.|||Participants|||Count of Participants
1466000|NCT00733980|Secondary|Number of Participants With Vital Sign of Potential Clinical Importance (PCI)|Vital sign measurements included height (screening only), systolic blood pressure(SBP) and diastolic blood pressure (DBP) and heart rate (HR). Sitting vital signs were measured at all clinic visits. Standing vital signs were measured at screening, Week 3 and at any other times as clinically indicated. Only the PCI values for SBP, DBP and HR were reported.|Up to Week 10|All subject population.|||Participants|||Count of Participants
1466001|NCT00733980|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to 28-day FU (18 months)|All subject population.|||Participants|||Count of Participants
1466002|NCT00733980|Secondary|Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6.|The PSS is most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in past month (how unpredictable, uncontrollable, and overloaded respondents find their lives). Individual items were rated on a scale of 0-4, where 0(never) to 4 (very often) that best describes how often they have had the feelings or thoughts described in the last month for each question. The total scores can range from 0-40, where 0 score indicated no stress and a higher score indicated more stress. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0. Thus a negative change from randomization indicated improvement.|Randomization (Week 0) and Week 6.|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1466026|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
1466003|NCT00733980|Secondary|Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6|The MOS-12 Sleep Scale is a 12-item questionnaire which measures specific aspects of sleep in participants that may have varying co-morbidities, as a result, is appropriate for a medically diverse participant population. It consist of following items: initiation (2 items), maintenance (2 items), respiratory problems (2 items), quantity (1 item), perceived adequacy (2 items), and somnolence (3 items). All items were given equivalent weightage from 1 to 6. Each index summarizes information across most or all sleep dimensions. The total score is transformed linearly to a common metric with a possible range of 0-100 and is averaged across items in the same scale. The higher score indicates a greater degree of the attribute implied by the scale name. Change from randomization was calculated by randomization value minus the value at Week 6. Randomization was defined as Week 0.|Randomization (Week 0) and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1466004|NCT00733980|Secondary|Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. The CGI –responders, are defined as participants with a score of 1 (very much improved) or 2 (much improved) in the CGI-I).|Weeks 1, 2, 4, and 6.||||perecntage of participants|||Number
1466005|NCT00733980|Secondary|Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.|The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. Both the CGI-I and CGI-S items are rated on a 1 to 7 point scale. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). Scores, on the CGI-S, range from 1 (normal, not ill at all) to 7 (amongst the most extremely ill). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Weeks 1, 2, 4, and 6.|ITT population|||Scores on scale||Standard Error|Least Squares Mean
1466006|NCT00733980|Secondary|Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6)|"The time to maintained antidepressant response at the end of treatment phase (week 6), as the participants with a > or = to 50 % reduction from randomization in their HAMD-17 total score, sustained until the end of the Treatment Phase [Week 6]). This OM time to maintained antidepressant response was not evaluated due to lower number of participants in the GSK561679 group as compared to placebo"|Week 6|Endpoint not evaluated.||||||
1466007|NCT00733980|Secondary|Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.|HAMD-17 Responders were defined as the participants with a > or = 50% reduction from randomization in their HAMD-17 total score at Weeks 1, 2, 4, and 6. The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranged from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicated at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity.|Weeks 1, 2, 4, and 6.|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
1466008|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)|The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranges from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2, 4 and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1466009|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.|The IDS-SR is self-report rating scale that assesses symptom severity of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), diagnostic criterion for major depressive disorder. The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. Each item has a 4-likert scale and each symptom item is given equivalent weightings and scored on 0 to 3 scale, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2,3, 4 and 6). Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2, 3,4 and Week 6|ITT population|||Scores on scale||Standard Error|Least Squares Mean
1466010|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)|HAM A, is internationally accepted and validated measurement tool for assessment of severity of anxiety symptoms. Used to assess severity of overall anxiety in participants who met criteria for anxiety of depressive disorders and to monitor outcome of treatment. Instrument does not distinguish symptoms of specific anxiety disorder or distinguish an anxiety disorder from an anxious depression. It is clinician-administered and consists of 14 individual questions, each rated on five point scale from 0 (not present) to 4 (very severe). Total HAM A range from 0 to 56 with higher scores reflecting more severe anxiety. Change from randomization was defined as post-baseline value minus value at randomization. Randomization was defined as Week 0. Provided no more than 1 response was missing for any one visit assessment for a participant, total score was calculated adjusting for missing data as follows: Total score = (14/13)* observed total score the score was rounded to nearest integer number.|Randomization (Week 0) and Week 1, 2, 4 and Week 6|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1466025|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
1470693|NCT00703391|Secondary|AZD9668 Sputum Concentrations||Pre-dose day -1 to post-dose on day 14||||nM||Full Range|Geometric Mean
1466011|NCT00733980|Secondary|Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.|The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2 and 4). Randomization was defined as Week 0.|Randomization (Week 0) and Week 1, 2 and 4|ITT population.|||Scores on scale||Standard Error|Least Squares Mean
1466012|NCT00733980|Primary|Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).|The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0.|Randomization (Week 0) and Week 6|Intent to Treat (ITT) population consisted of all participants who gave informed consent, were randomized, received at least one dose of double-blind medication, and had at least one post-randomization efficacy assessment available (HAM D, IDS-SR CGI, HAM A, MOS, PSS).|||Scores on scale||Standard Error|Least Squares Mean
1466013|NCT00733954|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment|Number of Participants with Tolerability assessments (Pruritus, Telangiectasias, Stinging/Burning, Skin atrophy, Folliculitis) resulting in adverse events from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|Safety|||Participants|||Number
1466014|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area treated (%BSA treated) from Baseline to two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||% BSA||Standard Deviation|Mean
1466015|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline two weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||% BSA||Standard Deviation|Mean
1466016|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment|Percent decrease from baseline in body surface area treated (%BSA treated) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||% BSA||Standard Deviation|Mean
1466017|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment|Percent decrease in body surface area affected (%BSA affected) from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||% BSA||Standard Deviation|Mean
1466018|NCT00733954|Secondary|Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment|Percent decrease from baseline in Body Surface Area treated (% BSA treated) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF|||% BSA||Standard Deviation|Mean
1466019|NCT00733954|Secondary|Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment|Percent decrease in Body Surface Area affected (% BSA affected) from Baseline to after two weeks of treatment|Baseline and Week 2|ITT, LOCF|||% BSA||Standard Deviation|Mean
1466020|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline and 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1466021|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1466022|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment|Success Rate on decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to 2 weeks post treatment (week 6 for clobetasol propionate spray and week 4 for clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1466023|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment|Success Rate on decrease in Signs of Psoriasis (plaque elevation) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being success and all others being failure from Baseline to end of treatment (week 4 for clobetasol propionate spray and week 2 for clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|ITT, LOCF|||Participants|||Number
1466027|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (scaling) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
1466028|NCT00733954|Secondary|Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment|Success Rate of decrease in Signs of Psoriasis (erythema) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost clear being success and all others being failure from Baseline to after 2 weeks of treatment|Baseline and Week 2|ITT, LOCF|||Participants|||Number
1466029|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity scale (Clear/Almost Clear, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst at 2 weeks post treatment (week 6 - clobetasol propionate spray and week 4 - clobetasol propionate ointment)|Baseline and Week 4 and Baseline and Week 6|ITT, LOCF|||Participants|||Number
1466030|NCT00733954|Secondary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe) with Clear/Almost Clear being best and Severe/Very Severe being worst from Baseline to after 2 weeks of treatment|Baseline and Week 2||||Participants|||Number
1466031|NCT00733954|Primary|Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale|Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)|Baseline and Week 2 and Baseline and Week 4|Intent-to-treat (ITT), Last observation carried forward (LOCF)|||Participants|||Number
1466032|NCT00733824|Secondary|Toxicity of the Combination IV AMD3100 and G-CSF to Mobilize ≥ 2 x 106 CD34+ Cells/kg as Measured by Number of Participants Who Experience Grade 3 or Higher Adverse Event Broken Down by Adverse Event||30 days post transplant||||participants|||Number
1466033|NCT00733824|Secondary|Pharmacodynamic Response to a Dose of SC AMD3100 as Measured by Mean Percentage of the Circulating CD34+ Count With the 34+RA-123+/- Phenotype||1 year||||mean percentage of total CD34+ cells||Standard Deviation|Mean
1466034|NCT00733824|Secondary|Kinetics of Stem Cell Mobilization Using IV AMD3100 as Measured by Median Fold Change in the Number of CD34+ Cells After AMD3100 IV Administration||From baseline to Day 1||||fold change||Full Range|Median
1466035|NCT00733824|Primary|Number of Participants Who Experienced Dose Limiting Toxicities in Phase I Portion of Study|Dose limiting toxicity: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause.|7 days from first dose of IV AMD3100||||participants|||Number
1466036|NCT00733824|Primary|Maximum Tolerated Dose (MTD) of IV AMD3100 + G-CSF in Mobilization of Peripheral Blood Stem Cell in Patients With Lymphoma (Phase I Only)|"MTD: the highest dose level of AMD3100 at which ≤ 1 of 6 participants experience a dose limiting toxicity (DLT). The MTD will be the Phase II dose.~DLT: selected grade III or higher (hematologic, cardiac, pulmonary, hepatobiliary/pancreatic, renal, or CNS) not attributable to any other cause."|7 days from first dose of IV AMD3100||||micrograms/kilograms|||Number
1466037|NCT00733746|Secondary|Response Rate|The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals.|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for protocol surgery were included in this endpoint.|||proportion of patients||95% Confidence Interval|Number
1466038|NCT00733746|Secondary|Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI’s Common Toxicity Criteria for Adverse Events|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting grade 3 or higher adverse events as graded by the NCI’s Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.|Up to 4 years postoperative chemotherapy treatment|All patients that started protocol treatment and were assessed for adverse events were included in this endpoint.|||Participants|||Count of Participants
1466039|NCT00733746|Secondary|Relapse/Progression-free Survival|Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression. If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death. If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred. If a patient is lost to follow-up, s/he will be censored at the data of last contact. The distribution of disease-free survival will be estimated using the method of Kaplan and Meier.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.|||months||95% Confidence Interval|Median
1466056|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 3 Missing outcome (0Inv & 3Contr)}|||Points|Participants|Standard Deviation|Mean
1466040|NCT00733746|Secondary|Resection Rate|"The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval.~Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles).~An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins)."|Up to 4 years postoperative chemotherapy treatment|All patients that completed neoadjuvant treatment and were eligible for surgery were included in this endpoint.|||proportion of patients||95% Confidence Interval|Geometric Least Squares Mean
1466041|NCT00733746|Primary|Overall Survival at 2 Years|The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.|At 2 years post-registration|All patients meeting the eligibility criteria who completed neoadjuvant therapy and underwent protocol surgery with R0 or R1 resection were evaluated for the primary endpoint.|||proportion of patients||95% Confidence Interval|Number
1466042|NCT00733512|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.|1 week to 10 months|contrast sensitivity data was received for only 51 of 146 patients.|||log units||Standard Deviation|Mean
1466043|NCT00733512|Primary|Visual Acuity|Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|1 week to 10 months||||logMAR||Standard Deviation|Mean
1466044|NCT00733499|Primary|Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.|The visual analog scale (VAS) pain score asks the subject to place a vertical mark anywhere on a horizontal line (that is approximately 10 cm long) with 'No pain' listed on the left (scored as 0) and 'Very severe pain' labeled on the right (scored as 10). The subject is instructed to indicate the amount of pain they feel in their knee joint|6 Months Post Surgery|The number of participants analysed is based on the number of case report forms measuring the VAS pain score that we have in our database at the 6 month time point.|||units on a scale||Standard Deviation|Mean
1466045|NCT00733421|Secondary|Patient Assessed Quality of Life|Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life|At 16-week post surgery follow-up||||score on a scale||Standard Deviation|Mean
1466046|NCT00733421|Secondary|Patient Assessed Overall Satisfaction With Surgery/Outcome|overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.|16 weeks||||Patients.|||Number
1466047|NCT00733421|Secondary|Satisfaction With Pain Medication|satisfied or unsatisfied with study medication, assessed by patient in questionnaire|during the first 20 days after surgery, 1st outpatient clinic visit||||patients|||Number
1466048|NCT00733421|Secondary|Wound Healing|healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad|16 week follow-up||||patients|||Number
1466049|NCT00733421|Secondary|Dizziness/Sleepiness|Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire|During the 7-day pain medication period||||patients|||Number
1466050|NCT00733421|Secondary|Gastro-intestinal Symptoms|Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire|during the 7- day pain medication period||||patients|||Number
1466051|NCT00733421|Secondary|Compliance to Base Medication|Number of patients that did not discontinue study medication before day 7|7-day study period, during study medication||||patients|||Number
1466052|NCT00733421|Secondary|Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain|VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70|The first 7 days after surgery, during study pain medication||||scores on a scale||Standard Deviation|Mean
1466053|NCT00733421|Primary|Number of Patients Requiring Rescue Medication|Number of patients requiring any further pain medication|7 day study period||||patients|||Number
1466054|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1466055|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (4Inv & 4Contr)+ 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466057|NCT00733369|Secondary|To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466058|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466059|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466060|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466061|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1466062|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466063|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466064|NCT00733369|Secondary|To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466065|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1466066|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466067|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466068|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466069|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1466070|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1466071|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome ( 0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1466072|NCT00733369|Secondary|To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466073|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|5 years|Study terminated early to slow recruitment rate. 5 Year data not available.||||Participants||
1466085|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|Study terminated early due to a slow recruitment rate. 5 year data not available.||||Participants||
1466217|NCT00732940|Secondary|Median Percent Change From Baseline in Anti-dsDNA at Week 24||Baseline, 24 weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466074|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|2 years|106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466075|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466076|NCT00733369|Secondary|To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.|3 - 6 months|106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466077|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.||||Participants||
1466078|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 2 Missing outcome (0Inv & 2Contr)}|||Points|Participants|Standard Deviation|Mean
1466079|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 year|106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466080|NCT00733369|Secondary|To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466081|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|5 years|Study terminated early due to a slow recruitment rate. 5 Year data not available.||||Participants||
1466082|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|2 years|106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466083|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|1 year|106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466084|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466218|NCT00732940|Secondary|Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24||Baseline, 24 Weeks|Analysis population includes only patients positive for anti-dsDNA (≥30 IU/mL) at baseline and must have had a baseline and Week 24 laboratory sample.|||IU/mL||Standard Error|Mean
1466086|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)}|||Points|Participants|Standard Deviation|Mean
1466087|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) }|||Points|Participants|Standard Deviation|Mean
1466088|NCT00733369|Secondary|To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|3 - 6 months|106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)}|||Points|Participants|Standard Deviation|Mean
1466089|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate. 5 Year data not available.||||Participants||
1466090|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}|||Points|Participants|Standard Deviation|Mean
1466091|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}|||Points|Participants|Standard Deviation|Mean
1466092|NCT00733369|Secondary|To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466093|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to slow recruitment rate, 5 year data not available.||||Participants||
1466094|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)}|||Points|Participants|Standard Deviation|Mean
1466115|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest). Pre-operatively, the subject must complete both a practice walk and a test walk.|pre-op|There were 5 missing outcomes for this endpoint.|||Feet||Standard Deviation|Mean
1470694|NCT00703391|Secondary|Sputum Differential Neutrophil Count|Change from baseline to Day 14 in percentage neutrophil count|Pre-dose day -1 to post-dose on day 14||||Percentage||Full Range|Median
1466095|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)}|||Points|Participants|Standard Deviation|Mean
1466096|NCT00733369|Secondary|To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466097|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|Study terminated early due to a slow recruitment rate.||||Participants||
1466098|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1466099|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1466100|NCT00733369|Secondary|To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466101|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study was terminated early due to a slow recruitment rate. 5 year data not available.||||Participants||
1466102|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 1 Contr)+ 3 Lost to follow up (2 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1466103|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1470695|NCT00703391|Secondary|Sputum Absolute Neutrophil Count|Change from baseline to Day 14 in absolute neutrophil count|Pre-dose day -1 to post-dose on day 14||||10**9/L||Full Range|Median
1466104|NCT00733369|Secondary|To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466105|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|5 years|This study has been terminated early, therefore the 5 year data was not collected.||||Participants||
1466106|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|2 years|106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1466107|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|1 year|106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)}|||Points|Participants|Standard Deviation|Mean
1466108|NCT00733369|Secondary|To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.|The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales – Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) – ranging from 0 to 100 point score (where 100 indicates the best outcome).|3-6 months|106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)}|||Points|Participants|Standard Deviation|Mean
1466109|NCT00733369|Primary|Change From Pre-op to 1 Year Range of Motion.|Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.|1 year|106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational &4 control) + 2 lost to follow up (1 Inv & 1 Contr) + 1 missing outcome (1 Inv & 0 Contr)}|||Degrees|Participants|Standard Deviation|Mean
1466110|NCT00733356|Primary|Gray Oral Reading Rest, Fourth Edition (GORT-4)|"The GORT-4 evaluates oral reading rate, accuracy and comprehension. Both Forms A and B were used.Half of the subjects randomly were tested on From A at baseline and the other half were tested with Form B.~The GORT-4 is a standardized measure/test. Scores provided are standard scores, which range from 1 to 20, with a Mean of 10 and Standard Deviation of 3. A higher score means better reading performance. There was no total score used or calculated in this study."|baseline and final day (lab school Assessments)||||units on a scale||Standard Deviation|Mean
1466111|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|6 months|There were 13 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
1466112|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|12 weeks|There were 32 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
1466113|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|8 weeks|There were 20 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.|||Feet||Standard Deviation|Mean
1466114|NCT00733330|Secondary|To Compare 6 Minute Walk Test Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|This score records the total distance walked (measured in feet) in 6 minutes (this time includes any time that the subject needs to stop and rest).|4 weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.|||Feet||Standard Deviation|Mean
1466219|NCT00732940|Secondary|Median Percent Change From Baseline in Complement C4 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466117|NCT00733330|Secondary|To Compare Interface Radiographic Appearance Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographer will observe and record alignment.|5 years|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1466118|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|6 months|There were 12 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||millimeters||Standard Deviation|Mean
1466119|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|12 Weeks|There were 37 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||millimeters||Standard Deviation|Mean
1466120|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|8 Weeks|There were 26 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow up for this endpoint.|||millimeters||Standard Deviation|Mean
1466121|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|4 Weeks|There were 23 missing outcomes and 1 Consent Withdrawal for this endpoint.|||millimeters||Standard Deviation|Mean
1466122|NCT00733330|Secondary|To Compare VAS Pain Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|A 100-mm visual analog scale (VAS) was used to assess pain after the subject completes the 6-minute walk test. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their knee joint.|pre-op|There were 3 missing outcomes for this endpoint.|||millimeters||Standard Deviation|Mean
1466123|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|5 years|The study was terminated early for business reasons therefore there are no outcomes for this endpoint.||||||
1466124|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|2 years|There were 44 missing outcomes, 3 Protocol Violations, 1 Consent Withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1466125|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|1 year|There were 25 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1466126|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|6 months|There were 16 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1466127|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|12 weeks|There were 36 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1466199|NCT00733005|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|Standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
1466128|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|8 weeks|There were 22 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 1 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1466129|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|4 Weeks|There were 21 missing outcomes and 1 consent withdrawal for this endpoint.|||points||Standard Deviation|Mean
1466130|NCT00733330|Secondary|To Compare WOMAC Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|WOMAC is a patient reported outcome (PRO) that evaluates the condition of subject's with knee osteoarthritis, and includes pain (score range 0-20), stiffness (score range 0-8), and physical function (score range 0-68) of the joint, where a lower score indicates a better outcome. The WOMAC total score is a combination of the three domains (pain, stiffness, and physical function) with a range of 0-96.|pre-op|There were 4 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
1466131|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|5 years|The study was terminated before completion due to business purposes, therefore there are no results for this outcome.||||||
1466132|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|2 years|There were 41 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1466133|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|1 Year|There were 21 missing outcomes, 3 protocol violations, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
1466134|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|6 Months|There were 10 missing outcomes, 1 protocol violation, 1 consent withdrawal and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
1466135|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|12 Weeks|There were 33 missing outcomes, 1 protocol violation, 1 consent withdrawal, and 2 Lost to Follow up for this endpoint.|||points||Standard Deviation|Mean
1466136|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 protocol violation, and 1 Lost to Follow Up for this endpoint.|||points||Standard Deviation|Mean
1466137|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this outcome.|||points||Standard Deviation|Mean
1466138|NCT00733330|Secondary|To Compare Oxford Knee Scores Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.|pre-op|There were 2 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
1466139|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|5 years|The study was terminated before completion due to business purposes, therefore no outcomes are available for this endpoint.||||||
1466140|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|2 years|There were 41 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.|||points||Standard Deviation|Mean
1466198|NCT00733005|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.|15 days of treatment|Standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
1466141|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|1 year|There were 22 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up, and 3 protocol violations for this endpoint.|||points||Standard Deviation|Mean
1466142|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|6 Months|There were 10 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
1466143|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|12 Weeks|There were 32 missing outcomes, 1 consent withdrawal, 2 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
1466144|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|8 Weeks|There were 19 missing outcomes, 1 consent withdrawal, 1 Lost to Follow Up and 1 protocol violation for this endpoint.|||points||Standard Deviation|Mean
1466145|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|The American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|4 Weeks|There were 19 missing outcomes and 1 consent withdrawal for this endpoint.|||points||Standard Deviation|Mean
1466146|NCT00733330|Secondary|To Compare American Knee Society Knee Score Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability.|Pre-op|Of the 84 subjects who received surgery, there were 3 missing outcomes for this endpoint.|||points||Standard Deviation|Mean
1466147|NCT00733330|Secondary|To Compare the Number of Optimal Implantations Achieved From Pre-op to 6-12 Weeks Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.|4 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1466148|NCT00733330|Secondary|To Compare the Proportion of Procedures That Fall Within a Satisfactory Alignment Window Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|An independent radiographic observer will determine and record alignment.|operative|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed and there are no results for this outcome.||||||
1466149|NCT00733330|Primary|To Compare the Precision of the Long Leg Alignment Between the Between Subjects Who Have Undergone Minimally Invasive vs. Conventional Total Knee Arthroplasty.|Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)|6 - 12 Weeks|The study was terminated before completion due to business purposes, therefore no radiographs were analyzed.||||||
1466150|NCT00733304|Secondary|Number of Participants With Lesion Types Over Period|Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.|Up to 6 months|Safety population.|||Participants|||Count of Participants
1466151|NCT00733304|Secondary|Change in Neo-vascular Size and Lesion Size Over Period|The analysis was planned to be performed up to 6 months; however, due to heterogeneity of the population and the low likelihood of the utility of the data, the anatomic effects of the pazopanib treatment in this treatment were limited to investigator determined assessment of OCT central subfield retinal thickness. Thus, the study team decided not to have DARC (central reading center) perform the grading for the secondary PD outcomes like lesion size and change with respect to time were not analyzed. Thus, data was not collected for this outcome measure.|Up to 6 weeks|PD population was planned for analysis of this outcome; however, Data was not collected for this outcome measure.||||||
1466152|NCT00733304|Secondary|Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months|The OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of Pazopanib. The anatomic effects of pazopanib treatment were limited to investigator determined assessment of OCT central subfield retinal thickness due to heterogeneity of participant population and the low likelihood of utility of central reading center determination. The OCT equipment used was approved by central OTC reading center. OCT scans were collected at indicated time points and were evaluated by Investigator. Thus, grading of further secondary objectives was not performed as per the study team. Change from Baseline is the value at indicated time point minus the Baseline value. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.|From Baseline (Screening visit) and up to 5 months|Pharmacodynamic subpopulation included participants that were analyzed for PD outcome measures. Only the participants available at the time of assessment were analyzed.|||Microns||Standard Deviation|Mean
1466164|NCT00733304|Primary|Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis|In this dipstick test, the level of blood occult and glucose, ketones, protein in urine samples were recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive).|Approximately up to 6 months (up to follow-up)|Safety population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1466153|NCT00733304|Secondary|Change From Baseline (Screening Visit) in BCVA at Month 2 and 5|Change from Baseline in BCVA is the value at indicated time point minus the Baseline value. BCVA at screening visit was used as statistical Baseline. Only data before post-dose intravitreal injection of Avastin/ Lucentis (IVT) has been presented. Arithmetic mean was presented as data values; however statistical analysis is based on means of observed case (OC) data. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.|From Baseline (screening visit), Month 2, and Month 5|Efficacy population included all participants in safety population who have classic choroidal neovascularization present as detected by fluorescein angiography in the previous screening visit.|||Number of letters||Standard Deviation|Mean
1466154|NCT00733304|Primary|Number of Participants With Abnormal (Dilated) Fundus Examination|Dilation of fundus was examined post dosing up to 6 months. Number of participants with abnormal change from Baseline indicating dilation of fundus of eye was reported. Change from Baseline was the value at indicated time point minus the Baseline value. The abnormalities were posterior vitreous separation, pale optic nerve, fluid in the posterior pole, drusen, thick arterio-venous changes, pigment changes, cystoids, macular edema, drying of posterior fluid or sub-retinal fluid, underlying central atrophy, and retinal pigment epithelial changes etc. Refraction measurement were determined at the screening and 2 month/5 month visits in order to determine BCVA.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1466155|NCT00733304|Primary|Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function|Meibomian gland dysfunction was measured as obvious insipisation/debris, mild injection, no trichiasis or lid thickening; inspisation, debris, obvious injection, lid thickening, may have trsichiasis; or a two step worsening. Any 2+ worsening of Meibomian gland function was considered a value of PCI.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1466156|NCT00733304|Primary|Number of Participants With Abnormal Tear Films of PCI|Tear film abnormalities were based on the clinical judgment of investigator. Tear film thickness was analyzed and it was reported whether the film was increased or decreased or was normal. Presence of debris or mucus was also reported. Other test were tear lake analysis and checking of discharge from eyes.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1466157|NCT00733304|Primary|Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale|A two step change in any of the lens opacity categories was considered a value of PCI. Aphakia (surgical removal of lens) or pseudophakia was noted if any. Stroma opacity or edema was measured by investigator when it was detected as edema or opacity in stroma.|Approximately up to 6 months|Safety population|||Participants|||Count of Participants
1466158|NCT00733304|Primary|Number of Participants With Abnormal Corneal Examination of PCI|A two step change in any of the lens opacity categories was categorized as of PCI. Corneal epithelium was defined as abnormal when punctate keratopathy was measured as mild, moderate, severe; epithelial edema was measured as subtle epithelial haze, mild patchy microcystic changes, diffuse microcystic changes, and/or investigator determined abnormality. Stromal opacity/ edema was measured by investigator when stroma identifies opacity or edema. Corneal staining was measured as obvious (<=20) localized or diffuse punctate staining areas, severe localized or diffuse punctate staining. Participants were analyzed for any of the mentioned abnormality over 6 weeks (up to follow-up period).|Approximately up to 6 months|Safety population|||Participants|||Count of Participants
1466159|NCT00733304|Primary|Number of Participants With Abnormal Anterior Chamber Examination of PCI|A two step worsening in the anterior chamber examination was considered a value of PCI. The participants were examined for any anterior chamber abnormality. Fibrinous response and obvious aqueous haze were considered abnormalities related to anterior chamber examination.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1466160|NCT00733304|Primary|Number of Participants With Abnormal Conjunctival Examination of PCI|A two step worsening in the conjunctival examination was considered a value of PCI. Participants were analyzed for conjunctival examination up to follow-up (6 months).|Up to follow-up (approximately 6 months)|Safety population.|||Participants|||Count of Participants
1466161|NCT00733304|Primary|Number of Participants With Abnormal Pupil Examination of PCI|Pupil abnormalities were of different types. Meibomian gland dysfunction was measured as obvious inspissation (debris). Mild injection, no trichiasis (lid thickening), or two step worsening was analyzed. Afferent pupillary defect, motility examination, PERRL, confrontation visual field was measured as a new definite abnormality. Left and right both eyes were examined.|Up to follow-up (approximately 6 months)|Safety population.|||Participants|||Count of Participants
1466162|NCT00733304|Primary|Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)|Visual acuity was measured over 5 months and also during follow-up period. Visual acuity was measured using standardized early treatment of diabetic retinopathy study (ETDRS) visual acuity charts. Visual acuity measurement was performed by an examiner that had been appropriately trained. Screening, Month 2 and Month 5 data were considered as Best Corrected Visual Acuity (BCVA) data. A loss of greater than or equal to 15 letters in BCVA from Baseline was considered of PCI. Data for number of participants who met the criteria for PCI have been presented.|Approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
1466163|NCT00733304|Primary|Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)|Number of participants with ocular and non-ocular AEs and SAEs were separately recorded. An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Approximately up to 6 months|Safety population.|||Participants|||Count of Participants
1470696|NCT00703391|Primary|QTcF|QTcF change from baseline greater than 60 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1466165|NCT00733304|Primary|Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Intra-ocular pressure was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
1466166|NCT00733304|Primary|Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. MCV was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed|||Femtoliters||Standard Deviation|Mean
1466167|NCT00733304|Primary|Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period|Change from Baseline (Day 1) is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Calcium, chloride, carbon di oxide equivalent content (CO2), glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) was recorded from Baseline up to Follow-up.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
1466168|NCT00733304|Primary|Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Direct bilirubin, total bilirubin, and creatinine were recorded from Baseline up to 6 months|Baseline (Day 1) and approximately up to 6 months|Safety population. Only those participants available at the time of assessment were analyzed.|||Micromoles per Liter (umol/L)||Standard Deviation|Mean
1466169|NCT00733304|Primary|Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Over here, the change is % Basophils at month x - % Basophils at Baseline. Baseline measurement was recorded at Day 1. Percentage change in the hematological parameter mentioned above was recorded from Baseline up to 5 months.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||Percentage of cells||Standard Deviation|Mean
1466170|NCT00733304|Primary|Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. The above mentioned hematological parameters were recorded from Baseline up to 5 months.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||Giga per Liter (G/L)||Standard Deviation|Mean
1466171|NCT00733304|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period|ALP, ALT and AST values were measured over 5 months and till the follow-up period. Baseline value was recorded pre-dose Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||International units per Liter (IU/L)||Standard Deviation|Mean
1466172|NCT00733304|Primary|Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period|Albumin and hemoglobin values were recorded at Baseline, Month2, and till follow-up (Month 6). Baseline was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1), Month 2, 5 and approximately up to Month 6|Safety population. Only the participants available at the time of assessment were analyzed.|||Grams per liter||Standard Deviation|Mean
1466173|NCT00733304|Primary|Change From Baseline (Day 1) in Heart Rate Over Period|Heart rate was measured over 6 months. Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Heart rate measurement were repeated in case it was in range < 50 beats per minute (bpm) or >110 bpm.|Baseline (Day 1) and approximately up to 6 months|Safety population. Only the participants available at the time of assessment were analyzed.|||bpm||Standard Deviation|Mean
1466174|NCT00733304|Primary|Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period|Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. SBP and DBP were recorded from Baseline up to 6 months. At screening and Baseline, if the single measured value of blood pressure was above 150 millimeters of mercury (mm Hg) systolic or 95 mm Hg diastolic, then blood pressure measurement could not be repeated. If, the SBP was <80 or >140 mm Hg and DBP was <40 or >90 mm Hg, then measurement of BP was repeated. Three consecutive blood pressure readings that were less than 150 mmHg systolic and 95 mmHg diastolic were taken with each measurement separated by at least 1 hour.|Baseline (Day 1) and approximately up to 6 months|Safety population included all participants who received at least one dose of the study drug. Only those participants available at the time of assessment were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1466175|NCT00733291|Primary|Total Corneal Staining Type|Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
1466176|NCT00733291|Secondary|Ocular Redness|"Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red."|After two hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
1466196|NCT00733096|Secondary|Oswestry Disability Score|0-100%. 0= no disability, 100% is complete disability|1 month|Patients who received epidural steroid injections|||percentage of disability out of 100%||95% Confidence Interval|Mean
1466177|NCT00733291|Primary|Average Corneal Staining Area|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Percentage area of cornea||Standard Deviation|Mean
1466178|NCT00733291|Secondary|Ocular Comfort|"Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable."|After 2 hours of wear|This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated.|||Units on a scale||Standard Deviation|Mean
1466179|NCT00733278|Secondary|Visibility Within the Vagina of IUD Strings at All Times.||At 3 days, 2 weeks and 6 weeks postpartum||||participants|||Number
1466180|NCT00733278|Primary|Successful Retention of IUD||6 weeks||||participants|||Number
1466181|NCT00733226|Secondary|Effect of OM-85 BV on Cytokine Levels|Cytokine levels were not measured during the trial because of unavailability of laboratory resources.|6 months|||||||
1466182|NCT00733226|Secondary|Duration of Hospitalization/Per Patient|Over the 12 months of the study we calculated mean duration of hospitalization/per patients.|12 months||||day/per patient||Standard Error|Mean
1466183|NCT00733226|Secondary|Number of Hospitalizations|"During the study period of 12 months all hospitalizations for wheezing attacks were recorded.~Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.~This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial."|12 months||||hospitalization/per patient||Standard Error|Mean
1466184|NCT00733226|Secondary|Number of Wheezing Attacks That Required Systemic Steroid Therapy|"All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.~At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group."|12 months||||wheezing attacks/per patient||Standard Error|Mean
1466185|NCT00733226|Secondary|Number of Common Cold|"All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.~This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial."|12 months||||common cold/per patients||Standard Error|Mean
1466186|NCT00733226|Secondary|Mean Duration (in Day) of Wheezing Attacks Per Patient|Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.|12 months||||day/per patient||Standard Error|Mean
1466187|NCT00733226|Primary|Mean Rate of Wheezing Attacks|Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.|12 months||||wheezing attacks/per patient||Standard Error|Mean
1466188|NCT00733135|Secondary|Preservation of Run-off Distal to the Filter|Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.|at the end of the procedure|115/133 subjects had the required angiographic images to assess this outcome.|||percentage of participants|||Number
1466189|NCT00733135|Secondary|Presence of Debris in Deployed SpiderFx™ Embolic Protection Device|Presence of debris in deployed SpiderFx™ embolic protection device|at the end of the procedure||||percentage of deployed filters|Participants||Number
1466190|NCT00733135|Secondary|Residual Diameter Stenosis|This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.|at the end of the procedure|1 lesion not included because there is no angiographic core laboratory post-treatment data available|||percentage of lesions|Participants||Number
1466191|NCT00733135|Secondary|Technical Procedural Success|"Technical Procedural Success was defined as meeting all of the following requirements:~Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory~No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC)~No device malfunction causing the procedure to be aborted~Successful delivery and placement of the SpiderFX™ embolic protection device"|at the end of the procedure|Total patient population minus one patient because there was no angiographic post-treatment core lab data available.|||percentage of participants|||Number
1466192|NCT00733135|Primary|Major Adverse Event Free Rate 30 Days|MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).|30 Days||||percentage of participants||95% Confidence Interval|Number
1466193|NCT00733135|Primary|Successful Revascularization|Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory|at the end of the procedure|Number of lesions assessed by the angiographic core lab|||percentage of lesions|Participants|95% Confidence Interval|Number
1466194|NCT00733096|Secondary|Medication Reduction|Number of people who reduced medications|1 month|Patients who underwent epidural steroid injections|||participants|||Number
1466195|NCT00733096|Secondary|Global Perceived Effect|Satisfaction. Number of participants with positive perceived global satisfaction.|1 month|Subjects who underwent epidural steroid injections|||participants|||Number
1466200|NCT00732992|Secondary|Summary of Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST): Number of Participants|Complete response (CR): disappearance of all target lesions; Partial response (PR): >=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): >=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of >=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started.|End of study (Up to individual study discontinuation)|Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST.|||Participants|||Number
1466201|NCT00732992|Secondary|Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 1 Day 14 (or 15): approximately 24 hours after the previous dose|Participants who provided a plasma concentration data was included in the analysis|||nanogram/mL||Standard Deviation|Mean
1466202|NCT00732992|Secondary|Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|"Terminal phase elimination half-life was calculated as natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)."|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||hours||Standard Deviation|Mean
1466203|NCT00732992|Secondary|AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct*/kel), where Ct* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.|Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||microgram*hour/mL||Standard Deviation|Mean
1466204|NCT00732992|Secondary|Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1||Cycle 2 Day 1: Pre-dose, 10 minutes after the start of infusion (immediately before the end of infusion), and 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||microgram/mL||Standard Deviation|Mean
1466205|NCT00732992|Secondary|Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||hours||Full Range|Median
1466206|NCT00732992|Secondary|AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||nanogram*hour/mL||Standard Deviation|Mean
1466207|NCT00732992|Secondary|Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1|Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.|Cycle 2 Day 1: Pre-dose and 2, 4, 6, 8, 10, and 24 hours post-dose|Participants who provided a plasma concentration data was included in the analysis.|||nanogram/mL||Standard Deviation|Mean
1466208|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 50 mg/Day Schedule-2/1 Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 6|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."|||percent of total planned dose||Full Range|Median
1466209|NCT00732992|Secondary|"Sunitinib Relative Dose Intensity in the Sunitinib 37.5 mg/Day Continuous Daily Dosing Treatment Arm"|Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.|Up to Cycle 5 (end of study)|"Full analysis set = defined as all enrolled patients. n = number of participants assessed for the relative dose intensity in the given period."|||percent of total planned dose||Full Range|Median
1466210|NCT00732992|Primary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.|End of study (up to individual discontinuation)|All subjects who received at least 1 dose of the study drug.|||Participants|||Number
1466211|NCT00732940|Secondary|Absolute Change From Baseline in Triglycerides at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||mmol/L||Standard Error|Mean
1466212|NCT00732940|Secondary|Median Percent Change From Baseline in Triglycerides at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466213|NCT00732940|Secondary|Median Percent Change From Baseline in Total Cholesterol at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466220|NCT00732940|Secondary|Absolute Change From Baseline in Complement C4 at Week 24||Baseline, 24 weeks|Analysis population includes only patients with low C4 (<16 mg/dL) at baseline and must have had a baseline and Week 24 laboratory sample.|||mg/dL||Standard Error|Mean
1466221|NCT00732940|Secondary|Median Percent Change From Baseline in Compliment C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466222|NCT00732940|Secondary|Absolute Change From Baseline in Complement C3 at Week 24||Baseline, 24 Weeks|Analysis population includes only patients with low C3 (<900 mg/L) at baseline and must have had a baseline and Week 24 laboratory sample.|||mg/L||Standard Error|Mean
1466223|NCT00732940|Secondary|Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24||Baseline, 24 weeks|LOCF|||Percentage||Standard Error|Mean
1466224|NCT00732940|Secondary|Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 Weeks|LOCF|||Points on a scale||Standard Error|Mean
1466225|NCT00732940|Secondary|Mean Percent Change From Baseline in PGA Score at Week 24.|The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 weeks|LOCF|||Percentage||Standard Error|Mean
1466226|NCT00732940|Secondary|Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24|PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.|Baseline, 24 Weeks|Last Observation Carried Forward (LOCF)|||Scores on a 3-point scale||Standard Error|Mean
1466227|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466228|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
1466229|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466230|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mL||Standard Error|Mean
1466231|NCT00732940|Primary|Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466232|NCT00732940|Primary|Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
1466233|NCT00732940|Primary|Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466234|NCT00732940|Primary|Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||cells/mm^3||Standard Error|Mean
1466235|NCT00732940|Secondary|Median Percent Change From Baseline in IgM at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466236|NCT00732940|Secondary|Absolute Change From Baseline in IgM at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
1466237|NCT00732940|Secondary|Median Percent Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466238|NCT00732940|Secondary|Absolute Change From Baseline in IgG at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
1466239|NCT00732940|Secondary|Median Percent Change From Baseline in IgA at Week 24||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||Percentage||Full Range|Median
1466240|NCT00732940|Secondary|Absolute Change From Baseline in IgA at Week 24||Baseline, 24 Weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||g/L||Standard Error|Mean
1466241|NCT00732940|Secondary|Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.||Baseline, 24 weeks|Analysis population includes all patients with both a baseline and Week 24 laboratory sample.|||µg/mL||Standard Deviation|Mean
1466242|NCT00732940|Primary|Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.|SEE ALSO ADVERSE EVENTS RESULTS SECTION|Up to 24 weeks|Please see Adverse Events Section|||Percentage of participants|||Number
1466243|NCT00732901|Secondary|Cocaine Positive Urines|Number of urine drug screens positive for cocaine metabolite benzoylecgonine.|5 weeks of treatment||||Positive urine drug screens|||Number
1466244|NCT00732901|Secondary|Attentional Bias as Measured by the Cocaine Stroop Task.|Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.|5 weeks of treatment||||milliseconds||Standard Deviation|Mean
1466307|NCT00732225|Secondary|Aqueous Signs - Corneal Edema|"Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings:~0 - None~- Mild, slight localized or generalized edema~- Moderate, significant localized or generalized edema~- Severe, advanced localized or generalized edema"|1 day after surgery|This data was collected on all eyes of patients attending the 1-day visit.|||Percentage of Eyes|||Number
1466245|NCT00732901|Primary|Immediate Memory Task|The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer’s left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or ‘false alarms’. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.|after acute dose and after chronic administration|Numerical data values are not accessible because PI transferred institutions. See references.||||||
1466246|NCT00732875|Primary|Number of Subjects Experiencing Any Infection||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study|||participants|||Number
1466247|NCT00732875|Primary|Number of Subjects Experiencing Serious Adverse Event|Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.|throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.|||participants|||Number
1466248|NCT00732875|Primary|Number of Subjects Experiencing Any Adverse Event||throughout entire study (61 +/- 28.9 weeks on average)|All participants were included regardless of how long they stayed in the study.|||participants|||Number
1466249|NCT00732758|Secondary|Collagen Type 1 Cross-linked C-telopeptide (CTx)|Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.|6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing participants with 6 month CTx data.|||ng/mL||Standard Deviation|Mean
1466250|NCT00732758|Secondary|Osteocalcin (OC)|Marker of bone formation|6 months|Intention to treat with participants analyzed in the group to which they were assigned but only using participants with 6 month OC data available.|||ng/mL||Standard Deviation|Mean
1466251|NCT00732758|Secondary|Parathyroid Hormone (PTH) Dietary Data||6 months|Intention to treat with participants analyzed by the group to which they were assigned but only analyzing those participants with follow up data for PTH at 6 months.|||pg/mL||Standard Deviation|Mean
1466252|NCT00732758|Primary|Serum 25-hydroxyvitamin D|Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations <20 ng/mL.|6 months|Intention to treat -- participants analyzed based on the group to which they were randomized but only included in the analysis if they had follow up data at 6 months.|||ng/mL||Standard Deviation|Mean
1466253|NCT00732680|Primary|Mean Score of Sino Nasal Outcome Test 22 (SNOT 22)|The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.|2 weeks after intervention, 2 months|No study data was collected in the study. The Lead investigator moved to a new medical center; the study was stopped when he left.||||||
1466254|NCT00732654|Primary|Oral Food Challenge Threshold (OFC) Threshold|mg CM protein|Change from baseline to after therapy (up to 18 months)||||mg||Full Range|Median
1466255|NCT00732654|Primary|Change in End Point Skin Test|Allergen provoked skin test (mm)|Change from baseline to after therapy (up to 18 months)||||mm||Full Range|Median
1466256|NCT00732654|Primary|Change in CM-specific Immunoglobulin G4 (IgG4)|Cow's milk specific IgG4 was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)||||kUa/L||Full Range|Median
1466257|NCT00732654|Primary|Change in CM-specific Immunogloblin E (IgE)|Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)|Change from baseline to after therapy (up to 18 months)|Data was not collected for one participant in the SLIT/OIT A group.|||kUa/L||Full Range|Median
1466258|NCT00732641|Secondary|Quality of Life|Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).|Screening and Last Observation (up to 5 years)|"Intent-to-treat population (those who received at least one dose of study drug).~The number of participants analyzed varied depending on the number of observations available for each category."|||Score on a scale||Standard Deviation|Mean
1466259|NCT00732641|Secondary|Number of Participants With Progressive Disease(PD) or Relapse From CR|"PD (for patients not in CR) required one or more of the following:~25% increase in serum monoclonal paraprotein level, 24-hour urinary light chain excretion, or plasma cells;~Increase in size of existing or development of new bone lesions/soft tissue plasmacytomas;~Development of hypercalcemia.~Relapse from CR required at least one of the following:~Reappearance of serum or urinary paraprotein;~>5% plasma cells;~Development of new lytic bone lesions or soft tissue plasmacytomas or increase in the size of residual bone lesions;~Development of hypercalcemia."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1466260|NCT00732641|Secondary|Number of Participants With Minimal Response (MR) to Treatment|"MR was defined as:~A 25-49% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks;~Reduction in the 24-hour urinary light chain excretion, which still exceeded 200mg/24 hours, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~A 25-49% reduction in the size of soft tissue plasmacytomas;~No increase in the size or number of lityc lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1466308|NCT00732225|Primary|Percent Loss of Endothelial Cells|Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope.|2 months following surgery|This data was collected on the eyes of patients attending the visit 2 months after surgery.|||Percent Loss||Standard Deviation|Mean
1466261|NCT00732641|Secondary|Number of Participants With Partial Response (PR) to Treatment|"PR was defined as:~At least 50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks;~Reduction in 24-hour urinary light chain excretion either by ≥ 90% or to < 200 mg, maintained for a minimum of 6 weeks;~For patients with non-secretory myeloma only, ≥ 50% reduction in plasma cells in a bone marrow aspirate and on a trephine biopsy, if biopsy was performed, maintained for a minimum of 6 weeks;~At least 50% reduction in the size of soft tissue plasmacytomas;~No increase in size or number of lytic bone lesions."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1466262|NCT00732641|Secondary|Number of Participants With Complete Response (CR) to Treatment|"CR was defined as:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks;~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy was performed.~No increase in size or number of lytic bone lesions (development of a compression fracture did not include response);~Disappearance of soft tissue plasmocytomas."|Month 9 & Month 18|Intent-to-treat population (those who received at least one dose of study drug)|||Participants|||Number
1466263|NCT00732641|Secondary|Number of Days of Overall Survival (OS)|"OS was calculated from the date of randomization to the date of death for any~cause. Participants alive at the end of study were censored at the last date they were known to be alive. Participants who were still living at the end of the study were censored on the last date they were known to be alive."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)|||Days||95% Confidence Interval|Median
1466264|NCT00732641|Primary|Number of Days With Progression Free Survival (PFS)|"PFS was defined as response duration while on maintenance therapy. It was the length of time during and after treatment in which a participant was living with the cancer that did not get worse.~PFS was calculated from the date of randomization to the date of the first documented tumor progression or relapse."|Baseline and up to 5 years (or to the date of the first documented tumor progression or relapse)|Intent-to-treat population (those who received at least one dose of study drug)|||Days||95% Confidence Interval|Median
1466265|NCT00732615|Secondary|Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24.|Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.|8 Weeks|Intent to Treat (ITT) population.|||percentage of participants|||Number
1466266|NCT00732615|Secondary|Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.|Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data.|||percentage of participants|||Number
1466267|NCT00732615|Secondary|Percentage Changes From Baseline in Daily Calcium Dose at Week 24.|The analysis of this endpoint was based on investigator prescribed data.|24 Weeks|Intent to Treat (ITT) population subjects with Baseline and Week 24 data|||percentage change from baseline||Standard Deviation|Mean
1466268|NCT00732615|Primary|The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.|The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.|Week 24 of dosing|Intent to Treat (ITT) population, which includes all randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
1466269|NCT00732472|Secondary|Urine Half Life (t1/2) of UMEC on Day 7|Urine half life (t1/2) of UMEC on Day 7 was estimated. Urine samples were collected from 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-4 hours (hr), 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.|||hours||Geometric Coefficient of Variation|Geometric Mean
1466270|NCT00732472|Secondary|Renal Clearance of UMEC on Day 1 and Day 7|Renal clearance was calculated as the urinary recovery of unchanged drug from time zero to time x (Ae[0-x])/area under concentration from time zero to time x (AUC[0-x]) for the longest period of time after dosing when both could be accurately determined (where x is either 8, 12, or 24). Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||Liters/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1466271|NCT00732472|Secondary|Fe(0-4), Fe(0-8), Fe(0-12), and Fe(0-24) of UMEC on Day 1 and Day 7|The fraction of the total dose excreted (Fe) in each interval was estimated as the urinary recovery of unchanged drug (Ae) per dose. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population: Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||Percentage of dose administered||Standard Deviation|Mean
1466282|NCT00732472|Primary|Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Concentration (MCHC) Values on Day 1 and Day 7|Blood samples were collected for the measurement of albumin, total protein, hemoglobin, and MCHC values pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Grams per liter (G/L)||Standard Deviation|Mean
1466272|NCT00732472|Secondary|Ae(0-4), Ae(0-8), Ae(0-12), and Ae(0-24) of UMEC on Day 1 and Day 7|Urinary recovery of unchanged drug (UMEC) within the first 8, 12, and 24 hours (Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 1 and within the first 4, 8, 12, and 24 hours (Ae[0-4], Ae[0-8], Ae[0-12], and Ae[0-24], respectively) on Day 7 was estimated. Urine samples were collected from 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1 and from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7.|From 0-8 hours (hr), 8-12 hr, and 12-24 hr on Day 1; from 0-4 hr, 4-8 hr, 8-12 hr, and 12-24 hr on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||nanograms (ng)||Geometric Coefficient of Variation|Geometric Mean
1466273|NCT00732472|Secondary|Tmax and Tlastof UMEC on Day 1 and Day 7|Tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last quantifiable concentration of UMEC; both were measured on Day 1 and Day 7. Blood samples were collected pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the PK Population.|||hours||Full Range|Median
1466274|NCT00732472|Secondary|Cmax of UMEC on Day 1 and Day 7|Cmax is defined as the maximum observed concentration of UMEC and was measured on Day 1 and Day 7. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|PK Population. Only participants with data available at the indicated time points were summarized.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1466275|NCT00732472|Secondary|Mean AUC(0-2), AUC(0-8), and AUC(0-t) of UMEC on Day 1 and Day 7|Area under the concentration-time (AUC) curve from time zero (pre-dose) to 2 hours (AUC[0-2]), from time zero to 8 hours (AUC[0-8]), from time zero to the last time of a quantifiable concentration of UMEC (AUC[0-t]) on Day 1 and Day 7 were measured. AUC is a measure of systemic exposure. Blood samples were collected pre-dose and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose on Day 1 and Day 7. Also, a 24 hr blood sample was collected on Day 7.|Day 1 and Day 7: pre-dose, and 5 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr post-dose; 24 hr post-dose on Day 7|Pharmacokinetic (PK) Population: participants (par.) in the ASP for whom a PK sample was obtained and analyzed. Different par. may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of par. summarized reflects everyone in the PK Population.|||hr * nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1466276|NCT00732472|Primary|Mean Corpuscle Volume (MCV) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCV pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||10^-15 liters (femtoliters)||Standard Deviation|Mean
1466277|NCT00732472|Primary|Mean Corpuscle Hemoglobin (MCH) Values on Day 1 and Day 7|Blood samples were collected for the measurement of MCH pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||picograms/cell (pg)||Standard Deviation|Mean
1466278|NCT00732472|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil (ANC: Absolute Neutrophil Count), Platelet, and White Blood Cell (WBC) Count Values on Day 1 and Day 7|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelets, and white blood cell (WBC) count pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
1466279|NCT00732472|Primary|Calcium, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values on Day 1 and Day 7|Blood samples were collected for the measurement of calcium, glucose, potassium, sodium, and urea/BUN pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1466280|NCT00732472|Primary|Direct Bilirubin, Total Bilirubin, and Creatinine Values on Day 1 and Day 7|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1466281|NCT00732472|Primary|Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Values on Day1 and Day 7|Blood samples were collected for the measurement of ALP, ALT, AST, and GGT Pre-dose on Day 1 and Day 7.|Day 1 and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||International units per liter (IU/L)||Standard Deviation|Mean
1466283|NCT00732472|Primary|Total Number of Salbutamol Doses Taken Over the 7 -Day Study Period|The total number of salbutamol doses taken per day was recorded by the participants in their dairy card over the entire 7-day treatment period. Diaries were reviewed by the Investigator when participants were admitted to the unit on Day 1, Day 7, and Day 8. Salbutamol was given as rescue medication, defined as a quick-relief or fast-acting medication that is given in addition to the investigational drug or placebo that can alleviate symptoms due to disease or lack of efficacy of the study treatment.|Day 1 to Day 7|All Subjects Population. Only those participants who took at least one dose of salbutamol were summarized.|||salbutamol doses|||Number
1466284|NCT00732472|Primary|Mean Forced Expiratory Volume in One Second (FEV1) at Screening and on Days 1 and 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured at Screening, pre-dose, and 4 hours (hr) post-dose on Day 1 and Day 7. FEV1 tests were repeated until three technically acceptable measurements were made.|Screening, Day 1, and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Liters||Standard Deviation|Mean
1466285|NCT00732472|Primary|Maximum and Mean (0-24 Hour) Heart Rate From Holter Monitoring on Day 7|Maximum heart rate (Max HR) and mean HR from 0-24 hour Holter monitoring on treatment Day 7 were derived. The analysis was adjusted for treatment and Baseline, where Baseline is defined as the corresponding summary measure (i.e., mean heart rate [0-24 hours] or maximum heart rate [0-24 hours]) from screening records.|Day 7|All Subjects Population. The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.|||Beats per minute||Standard Error|Least Squares Mean
1466286|NCT00732472|Primary|Number of Participants With Abnormal 24-hour Holter Findings at Screening and Day 7|Twenty-four hour Holter ECG values were obtained at Screening and on Day 7. During the Screening procedure and study, standard Holter monitors were used (in order to exclude participants with underlying cardiac arrhythmogenicity). During the treatment periods, Holter monitors were only switched on immediately prior to dosing (up to 15 minutes pre-dose) so as to capture Holter ECG data from the 24 hour period following dosing. The following summary data were transcribed into the Case Report Form: Maximum and mean (0 to24 hour) heart rate; normal and aberrant beats and arrhythmias. Analysis of the Holter tapes was arranged by GlaxoSmithKline.The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at Screening and Day 7, are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Screening and Day 7|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Participants|||Number
1466287|NCT00732472|Primary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Values on Days 1 and 7|The number of participants with normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) ECG findings, as well as those with unavailable results (NA) at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose (PD1, PD2, PD3), and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose on Day 7 are reported. The following are of potential clinical importance: absolute QTc interval >450 milliseconds (msec); increase from Baseline QTc >60 msec; PR interval <110 and >220 msec; QRS interval <75 and >110 msec. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Day 1 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr)|All Subjects Population. Only participants with data available at the indicated time points were summarized.|||Participants|||Number
1466288|NCT00732472|Primary|Maximum and Weighted Mean (0-4 Hour) Heart Rate at Days 1 and 7|Maximum heart rate (Max HR) and weighted mean (WM) from 0-4 hour on Days 1 and 7 were derived. Max HR (0-4 h) is defined as the maximum heart rate attained within 0-4 h. The weighted mean HR (0-4 h) was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Each of the maximum and weighted mean (0-4h) endpoints for heart rate, was statistically analyzed using a mixed effects model. The terms treatment, baseline, day and any relevant interactions were considered in the model. Least squares means are adjusted for treatment, Baseline, day, treatment by Baseline and Baseline by day interaction, where Baseline is defined as the mean of the three pre-dose assessments.|Day 1 and Day 7|All Subjects Population (ASP). The number of participants presented represent those with data available at the time point being presented; however, all participants in the ASP without missing covariate information are included in the analysis.|||Beats per minute||Standard Error|Least Squares Mean
1466289|NCT00732472|Primary|Mean Heart Rate (HR) on Days 1 and 7|HR was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. HR was obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population. Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Beats per minute||Standard Deviation|Mean
1466290|NCT00732472|Primary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) on Days 1 and 7|Blood pressure was measured in a semi-recumbent position at approximately 45 degrees after the participant was kept at rest for at least 5 minutes. SBP and DBP were obtained at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, and 8 hr post-dose (PD) on Day 1 and at pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr PD on Day 7.|Day 1 (pre-dose and 15 minutes [min], 45 min, 1.5 hours [hr], 4 hr, and 8 hr post-dose) and Day 7 (pre-dose and 15 min, 45 min, 1.5 hr, 4 hr, 8 hr, and 24 hr post-dose)|All Subjects Population (ASP). Only participants with data available at the indicated time points were summarized. Different participants may have been summarized for different parameters/at different time points (reflected by n=X, X, X, X in the category titles), so the overall number of participants summarized reflects everyone in the ASP.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1466359|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 4|Subject Satisfaction - ease of inflation|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466291|NCT00732472|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or Any On-treatment Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An on-treatment adverse event is defined as an event that occurred between the start of investigational product and follow-up contact. Refer to the general SAE/non-serious AE module for a complete list of AEs reported in the study. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From start of treatment to study day 12|All Subjects Population: all participants who received at least one dose of study medication|||participants|||Number
1466292|NCT00732381|Secondary|The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment||||Units on a scale||Standard Deviation|Least Squares Mean
1466293|NCT00732381|Primary|The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective])|15 days of treatment|The standard deviation is pooled.|||Units on a scale||Standard Deviation|Least Squares Mean
1466294|NCT00732303|Secondary|Overall Survival|To determine overall survival of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|No data was collected and analyzed for this outcome measure due to termination of the study.||||||
1466295|NCT00732303|Secondary|Assess Safety and Toxicity|- To determine the toxicities of pemetrexed and concurrent definitive radiation in patients with poor risk stage III NSCLC.|24 months|Most frequent toxicities reported.|||participants|||Number
1466296|NCT00732303|Primary|Progression Free Survival|To determine progression free survival in patients with poor risk stage III NSCLC treated with pemetrexed and concurrent definitive radiation|24 months|No data was collected and analyzed for this outcome measure due to termination of the study||||||
1466297|NCT00732251|Secondary|Hamilton Depression Scale (HAM-D)||2 Years|||||||
1466298|NCT00732251|Primary|Young Mania Rating Scale (YMRS)||2 Years|Only 1 subject completed the study. The other 6 withdrew at Week 1, Month 3, Month 5, Month 7, Month 11, and Month 13. Due to the closure of the Psychiatry Dept, the study was terminated; no analysis was completed.||||||
1466299|NCT00732238|Secondary|The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy|Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf)|Up to 180 days of end of therapy||||participants|||Number
1466300|NCT00732238|Primary|The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect||Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm)||||participants|||Number
1466301|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 20 DuoVisc eyes, 6 BioVisc eyes,4 Healon5 eyes, and 14 Amvisc Plus eyes.|||Percentage of Eyes|||Number
1466302|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye during Phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 19 DuoVisc eyes, 6 BioVisc eyes,3 Healon5 eyes, and 11 Amvisc Plus eyes.|||Percentage of Eyes|||Number
1466303|NCT00732225|Secondary|Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a patient's eye During Anterior Capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes|||Percentage of Eyes|||Number
1466304|NCT00732225|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure between 10 mmHg and 20 mmHg.|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit with the exception of the following: 3 DisCoVisc patients, 4 DuoVisc patients, 1 Healon5 patient, and 4 Amvisc Plus patients.|||mmHg||Standard Deviation|Mean
1466305|NCT00732225|Secondary|Aqueous Signs - Aqueous Cells|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings:~0 - None~- 1 to 5 cells~- 6 to 15 cells~- 16 to 30 cells~- >30 cells"|1 day following surgery|This data was collected on all eyes of patients attending the 1 day post-operative visit.|||Percentage of Eyes|||Number
1466306|NCT00732225|Secondary|Aqueous Signs – Aqueous Flare|"Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings:~0-None: No visible flare when compared with the normal eye.~Mild: Flare visible against dark papillary background but not visible against iris background.~Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 day following surgery|This data was collected on all eyes of patients attending the 1 day postoperative visit.|||Percentage of Eyes|||Number
1466309|NCT00732212|Other Pre-specified|Hospital Days After Randomization|Comparisons of days spent in the ICU and hospital will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Days||Standard Deviation|Mean
1466310|NCT00732212|Secondary|Units of Red Blood Cells (RBC) Transfused for Rebleeding After Randomization|RBC units of transfusion post-randomization will be quantitated & compared in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Units of RBC||Standard Deviation|Mean
1466311|NCT00732212|Secondary|Death|Death up to 30 days from a co-morbid condition, bleeding, or another cause in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1466312|NCT00732212|Secondary|Rate of Complications|Rates for each treatment group will be determined and compared for General medical complications (pneumonia, infection, myocardial infarction, stroke) & GI procedure related (perforation, aspiration) up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1466313|NCT00732212|Secondary|Rates of Surgery up to 30 Days After Randomization|GI surgery rate for control of active bleeding or rebleeding - up to 30 days after randomization in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1466314|NCT00732212|Primary|30 Day Rebleeding Rate|The primary outcome is index lesion rebleeding rate up to 30 days in 2 subgroups- non-variceal or variceal-portal hypertension lesions according to standard visually guided hemostasis vs. Doppler assisted.|30 days||||Participants|||Count of Participants
1466315|NCT00732199|Secondary|Brief Hyperoxia Response|Brief hyperoxia response was the nadir minute ventilation achieved immediately upon exposure to brief hyperoxia expressed as a percent of eupneic minuted ventilation.|4-6 wks for each participant|young adults: 3 women/6 men; older adults: 6 women/4 men; participants with data available were included in the analysis|||percentage of eupneic minute ventilaion||Standard Error|Mean
1466316|NCT00732199|Secondary|Hypoxic Ventilatory Response|Hypoxic ventilatory response was calculated as the change in minuted ventilation for a change in oxygen saturation during each hypoxia trial.|4-6 wks for each participant|older adults: 7 women/6 men; young adults: 6 women/4 men;participants with data available were included in the analysis|||Liter/minute/%saturation||Standard Error|Mean
1466317|NCT00732199|Primary|Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only|Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.|4-6 wks for each participant|Older adults 8 women/6 men;participants with data available were included in the analysis|||percentage of control minute ventilation||Standard Error|Mean
1466318|NCT00732199|Primary|Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve|The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.|4-6 wks for each participant|Older adults : n=10, 6 females/4 males Young n=15, 8 females/ 7 males; participants with data available were included in the analysis|||mm Hg||Standard Error|Mean
1466319|NCT00732160|Secondary|Insulin Sensitivity|Insulin sensitivity index (ISI) was calculated by dividing the average glucose infusion rate (mg glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL) from 90 to 120 minutes. This was multiplied by 100 (thus, x100 in units description), per reporting convention in literature.|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.|||mg/kg/min per uU/mL*100||Standard Deviation|Mean
1466320|NCT00732160|Primary|Insulin Secretion|Acute Insulin response during Hyperglycemic clamp (delta insulin uU/mL, t=0-10)|3 hours|Three subjects were excluded or withdrew after infusion but before hyperglycemic clamp due to low potassium, loss of IV access, burning at IV site. These 3 participants were not included in final analysis.|||uU/mL||Standard Deviation|Mean
1466321|NCT00732069|Secondary|F2-Isoprostanes|Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo|During dialysis after one week of study drug||||pg/mL||Standard Error|Mean
1466322|NCT00732069|Primary|Interleukin 1 Beta|Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo|During dialysis after one week of study drug|All participants who completed the three arm treatment.|||pg/mL||Standard Error|Mean
1466323|NCT00732030|Secondary|Patient Satisfaction Survey|Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.|6 months||||Units on a Scale||Standard Deviation|Mean
1466324|NCT00732030|Primary|Residual Refractive Cylinder|Residual Refractive Cylinder at month 6 measured in diopters (D).|6 Month||||Diopters||Standard Deviation|Mean
1466325|NCT00732030|Primary|Best Corrected Distance Visual Acuity|Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 Months|Data was collected for 29 eyes in 24 patients.|||logMAR||Standard Deviation|Mean
1466326|NCT00732030|Primary|Uncorrected Distance Visual Acuity|Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA).|6 months|Data was collected for 29 eyes in 24 patients.|||logMAR||Standard Deviation|Mean
1466327|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|6 months||||units on a scale||Standard Deviation|Mean
1466328|NCT00731939|Secondary|Assess Partner Satisfaction (Where Applicable)|The Partner Treatment Satisfaction Scale (TSS) was used. The TSS provides scores ranging from 0 to 100 in 5 domains of Ease of erection, Erectile function, Pleasure from sexual activity, Satisfaction with orgasm and Confidence to complete sexual activity with higher scores indicative of worse symptoms. Available data is summarized for each domain at each visit along with change from baseline.|Baseline||||units on a scale||Standard Deviation|Mean
1466329|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 9|How likely the subject will need continued training or retraining?|6 weeks||||percentage of participants|||Number
1466330|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 8|How easy was it for the subject to learn?|6 weeks||||percentage of participants|||Number
1466331|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 7|The subject likes the OTR pump?|6 weeks||||percentage of participants|||Number
1466332|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 6|The OTR pump was easy to use at 1st cycling?|6 weeks||||percentage of participants|||Number
1466333|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 5|Subject training with OTR pump was easier than with previous pump?|6 weeks||||percentage of participants|||Number
1466334|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 4|It was easy for the subject to compress the deflation touch pads?|6 weeks||||percentage of participants|||Number
1466335|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 3|It was easy for the subject to inflate the device?|6 weeks||||percentage of participants|||Number
1466336|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 2|It was easy for the subject to find the deflation touch pads?|6 weeks||||percentage of participants|||Number
1466337|NCT00731939|Secondary|Assess the Ease of Training for Titan® OTR - Question 1|It was easy for the subject to find the inflation bulb?|6 weeks||||percentage of participants|||Number
1466338|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 3|The subject was easily able to accommodate the OTR pump?|At implant||||percentage of responses|||Number
1466339|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR - Question 2|Titan OTR pre-implant product preparation was easier than your usual pump of choice?|At implant||||percentage of responses|||Number
1466340|NCT00731939|Secondary|Assess the Ease of Implant of the Titan® OTR Question 1|Titan OTR pre-implant product preparation was straightforward/simple?|At implant||||percentage of responses|||Number
1466341|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|12 months post-surgery||||"% responding yes and probably"|||Number
1466342|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|6 months post-surgery||||"% responding yes and probably"|||Number
1466343|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 10|Subject Satisfaction - if you had the decision to make again, would you undergo this penile implant procedure again?|3 months post-surgery||||"% responding yes and probably"|||Number
1466344|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|12 months post-surgery||||"% responding yes and probably"|||Number
1466345|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|6 months post-surgery||||"% responding yes and probably"|||Number
1466346|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 9|Subject Satisfaction - would you recommend this penile implant device to men with the same erectile difficulty that you had?|3 months post-surgery||||"% responding yes and probably"|||Number
1466347|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466348|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466349|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 8|Subject Satisfaction - length when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466350|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466351|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466352|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 7|Subject Satisfaction - width when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466353|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466354|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466355|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 6|Subject Satisfaction - hardness of erection when inflated|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466356|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|12 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466357|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|6 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466358|NCT00731939|Secondary|Evaluate User Acceptance of Titan® OTR - Question 5|Subject Satisfaction - ease of deflation|3 months post-surgery||||% satisfactory or somewhat satisfactory|||Number
1466371|NCT00731939|Primary|Assess the Ease of Deflation of the Titan® OTR Pump|"The study's primary endpoint was to demonstrate that at least 64% of subjects were mostly or completely satisfied with the ability to deflate the device at the 6-month follow-up. The study's primary objective was to assess the ease of deflation of the Titan® OTR pump via subject questionnaire at 6-month follow-up. Subjects were asked via questionnaire how satisfied they were with ease of deflation of their implant. Success criteria was a response of satisfactory or somewhat satisfactory. Other possible responses were neither satisfactory nor unsatisfactory, somewhat unsatisfactory, and very unsatisfactory."|6 months||||% of participants meeting success criter|||Number
1466372|NCT00731874|Secondary|Development of New Onset Diabetes Mellitus||36 months|||||||
1466373|NCT00731874|Secondary|Incidence of Opportunistic Infection||36 months|||||||
1466374|NCT00731874|Secondary|Severity of Acute Rejection (by Banff Criteria and Need for Anti-lymphocyte Agents to Treat Acute Rejection)||12, 24, 36 months post-transplant|||||||
1466375|NCT00731874|Secondary|Time to Acute Rejection||12, 24, 36 months post-transplant||||months||Full Range|Median
1466376|NCT00731874|Secondary|Perforin and Granzyme B mRNA Levels in Urine||Continuous|||||||
1466377|NCT00731874|Secondary|Renal Function (Estimated Glomerular Filtration Rate)||12, 18, 24, 36 months post-transplant|||||||
1466378|NCT00731874|Secondary|Incidence and Severity of Chronic Allograft Nephropathy||12, 24, 36 months post-transplant|||||||
1466379|NCT00731874|Secondary|Graft Survival||12, 18, 24, 36 months post-transplant|||||||
1466380|NCT00731874|Secondary|Patient Survival||12, 18, 24, 36 months post-transplant|||||||
1466381|NCT00731874|Primary|The Primary Endpoint Will be a Composite of the Following: Biopsy-confirmed Acute Rejection and Progression of Histologically Proven Chronic Allograft Nephropathy at 15 Months After Transplantation.||15 months post-transplant||||participants|||Number
1466382|NCT00731822|Secondary|Mean Change From Baseline (Pre-dose on Day 1) in Weighted Mean FEV1 (0-4 Hours Post-dose) on Days 1 and 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry at the Day 1 and Day 28 clinic visits (60 minutes pre-dose; immediately pre-dose; post-dose after 5, 15, and 30 minutes and 1, 2, and 4 hours. Weighted mean was calculated using the 24-hour serial FEV1 measurements that included the 0 to 4 hours post-dose assessment. At each time point, the highest of 3 technically acceptable measurements was recorded. Baseline FEV1 was defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the average Day 28 FEV1 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline (pre-dose on Day 1); Day 1 and Day 28|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1466383|NCT00731822|Secondary|Mean Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) on Days 2, 15, and 29|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Days 2, 15, and 29 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Days 1, 14, and 28. The highest of 3 technically acceptable measurements was recorded. Baseline FEV1 is defined as the mean of the two assessments obtained 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline was calculated as the Day 29 value minus the Baseline value. Analysis was performed using Mixed Model Repeated Measures (MMRM) with covariates of Baseline FEV1, sex, age, smoking status, treatment and day, and day by treatment and day by Baseline interactions.|Baseline; Day 2, Day 15, and Day 29|ITT Population. The number of participants presented (indicated by n=X, X in the category titles) represents the number of participants with data available at that time point. However all participants in the ITT Population without missing covariate information and with at least one post-Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
1466384|NCT00731822|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Study|Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.|From Baseline (Day 1) until Follow-up (up to Study Day 37)|ITT Population|||participants|||Number
1466385|NCT00731822|Primary|Change From Baseline in Weighted Mean Heart Rate 0-4 Hours Post-dose at the End of the 28-day Treatment Period|Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.|Baseline to Day 28|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. The number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT Population without missing covariate information and with >=1 post-BL measurement are included in the analysis.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
1466386|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|12 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1466387|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|6 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1466388|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|3 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1466389|NCT00731783|Secondary|Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.|Recurrence of CA-MRSA Skin or Soft Tissue Infection|1 month after enrollment|Modified intention to treat analysis|||Participants|||Number
1466390|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|12 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1466391|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|6 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1466392|NCT00731783|Secondary|Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|3 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1466393|NCT00731783|Primary|Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures|Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.|1 month after enrollment.|Modified intention to treat analysis|||Participants|||Number
1466394|NCT00731731|Secondary|Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)|"The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing."|Up to 5 years||||participants evaluable for toxicity|||Number
1466395|NCT00731731|Secondary|Time to Tumor Progression (Phase II)|Progression free survival time will be defined from date of registration to date of progression or death.|Up to 5 years||||months||95% Confidence Interval|Median
1466396|NCT00731731|Secondary|Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade|Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given.|Up to 5 years||||participants evaluable for toxicity|||Number
1466397|NCT00731731|Primary|Overall Survival at 15 Months (Phase II)|The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date.|Time from study registration to the date of death from any cause, assessed up to 5 years||||percentage of phase II patients||95% Confidence Interval|Number
1466398|NCT00731731|Primary|Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)|"The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.~>~>~DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs:~Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting > 7 days~Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism~Grade 4 radiation-induced skin changes~Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs"|10 weeks||||number of patients with DLT|||Number
1466399|NCT00731692|Secondary|Change in MSFC Z-score and Subscale Scores From Baseline to Month 36|The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.|Baseline to Month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS|||Z-scores||Standard Deviation|Mean
1466400|NCT00731692|Secondary|Blood Concentrations of Fingolimod and Fingolimod-phosphate|"Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.~Venous blood samples were collected for the analysis."|Month 3 up to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. (N). Only participants (n) who provided one or more evaluable blood concentration were included in the pharmacokinetic analysis population. Analysis include 147 patients (cohort 1)|||ng/ml||Standard Deviation|Mean
1466411|NCT00731692|Secondary|Percent Change From Baseline in Brain Volume at Month 36|The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. N= Total number of patients included in the analysis.|||Percent Change||95% Confidence Interval|Least Squares Mean
1466401|NCT00731692|Secondary|Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)|The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1466402|NCT00731692|Secondary|Change From Baseline in European Quality of Life – 5 Dimensions (EQ-5D Score)|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1466403|NCT00731692|Secondary|Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score|Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1466404|NCT00731692|Secondary|Change From Baseline in PRIMUS-Activities|The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1466405|NCT00731692|Secondary|Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)|The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score|Baseline, 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.|||Score on a scale||Standard Deviation|Mean
1466406|NCT00731692|Secondary|Percent Change in Total T2 Lesion Volume From Baseline to Month 36|Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis|Baseline to month 36|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percent Change||Standard Deviation|Mean
1466407|NCT00731692|Secondary|Number of Gd-enhancing Lesions at Month 36|Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Gd-enhanced lesions per patient per scan||95% Confidence Interval|Least Squares Mean
1466408|NCT00731692|Secondary|Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36|Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis|Baseline to 36 months|Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||T2 Lesions per year||95% Confidence Interval|Least Squares Mean
1466409|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.|The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants|||Number
1466410|NCT00731692|Secondary|Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentge of Participants|||Number
1466412|NCT00731692|Secondary|Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)|The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants||95% Confidence Interval|Number
1466413|NCT00731692|Primary|Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint|3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25’ TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25’ TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.|up to 36 months after the last patient was randomized|Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.|||Percentage of Participants||95% Confidence Interval|Number
1466414|NCT00731679|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.|||percentage of responders|||Number
1466415|NCT00731679|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug.|||percentage of responders|||Number
1466416|NCT00731666|Secondary|The Rate of Change in Male Stress Urinary Incontinence(SUI).|"Subject responses to 3 questions were evaluated:~On average, how many of these (pads, tissues, disposable undergarments) would you use to protect against wetness during the day?~Overall, how often have you needed to change your daily activities because of urinary incontinence?~Overall, how big of a social problem has urinary incontinence been for you during the past month?"|12 months||||percentage of participants|||Number
1466417|NCT00731666|Secondary|Assess Participant Satisfaction With the Penile Length at Baseline, 12 and 24 Months Post Implantation Via Participant Questionaire.||12 and 24 months|Subjects implanted with Titan IPP|||percentage of participants|||Number
1466418|NCT00731666|Primary|The Study's Primary Objective Will Assess the Change in Penile Length.||12 months||||cm||Standard Deviation|Mean
1466419|NCT00731653|Primary|The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.||Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)|All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.|||participants|||Number
1466420|NCT00731640|Secondary|Spectacle Independence|The percentage of patients reporting spectacle independence (no longer needing to wear glasses).|6 Months||||Percentage of Participants|||Number
1466421|NCT00731640|Secondary|Patient Satisfaction|Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).|6 Months Postoperative||||Units on a Scale||Standard Deviation|Mean
1466422|NCT00731640|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 Months||||Log Units||Standard Deviation|Mean
1466423|NCT00731640|Primary|Visual Acuity|Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months||||LogMar||Standard Deviation|Mean
1466424|NCT00731614|Secondary|SF-12|the SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning.|Baseline, end of treatment, 12 weeks posttreatment, 24 weeks posttreatment||2015-06-30|06/2015||||
1466425|NCT00731614|Primary|Phantom Limb Pain Questionnaire|The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)|Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.|Data analyzed for participants with complete data for all assessments using repeated measure ANOVA.|||units on a scale||Standard Error|Mean
1466426|NCT00731549|Secondary|Percentage of Participants Who Discontinued Due to All Causes.|Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included.|||Percentage of participants|||Number
1466427|NCT00731549|Secondary|Mean Clinical Global Impression of Improvement (CGI-I) Score.|To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 2, 4, 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1466428|NCT00731549|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.|PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1466429|NCT00731549|Secondary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.|To assess CGI-S, the rater or physician will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1466430|NCT00731549|Secondary|Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.|PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.|Baseline, Weeks 12, 24, 52 and last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.|||Units on a scale||Standard Deviation|Mean
1466431|NCT00731549|Secondary|Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.|Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.|Baseline to Week 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed had available assessments for evaluation of exacerbation of psychotic symptoms/impending relapse.|||Percentage of participants|||Number
1466432|NCT00731549|Secondary|Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.|"Stable was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here."|Baseline to Week 28|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.|||Percentage of participants|||Number
1466433|NCT00731549|Secondary|Percentage of Participants Achieving Remission.|Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.|Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
1466450|NCT00731133|Secondary|Proportion of Amphetamine-positive Urine Samples|the proportion of urine samples positive for amphetamine. Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|thrice weekly for 6 weeks|Only data from participants who received more than one dose of disulfiram were analyzed. Of the 15 participants who entered the study, one participant received only one dose so data from 14 participants were analyzed.|||proportion of urines positive for amphet||Standard Deviation|Least Squares Mean
1466500|NCT00730925|Secondary|Progression Free Survival (PFS) Time|PFS time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Weeks||95% Confidence Interval|Median
1466434|NCT00731549|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.|"Impending relapse criteria was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage."|Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
1466435|NCT00731549|Primary|Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).|"Stable was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here."|Baseline to Week 52/Last visit|All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.|||Percentage of participants|||Number
1466436|NCT00731484|Primary|Tear Osmolarity in Human Measured by TearLab System|Tear osmolarity was measured with a laboratory-on-a-chip, which simultaneously collects and analyzes the electrical impedance of a 50 nL tear sample from the inferior lateral meniscus (TearLab Osmolarity System). The results are reported in mOsm/L. The trial was not set up to evaluate diagnostic performance, as no gold-standard method was used to establish dry eye status, but rather, to determine whether the TearLab could measure tear osmolarity in human subjects.|Single visit, at time of tear osmolarity testing.|Healthy normal volunteers as well as subjects diagnosed with moderate or severe chronic dry eye disease and/or Sjögrens Syndrome|||mOsms/L||Full Range|Mean
1466437|NCT00731341|Secondary|Physician's Satisfaction From the Ease and Convenience of the Cryoablation Procedure|Physician's satisfaction from the ease and convenience of the cryoablation procedure using a scale of 1 (very satisfied) to 5 (very dissatisfied).|Post procedure||||Score from 1 to 5||Full Range|Mean
1466438|NCT00731341|Secondary|Evaluation of Length of an Average Cryoablation Procedure|Evaluation of length of an average cryoablation procedure for the treatment of uterine fibroids|Post procedure||||Minutes||Full Range|Mean
1466439|NCT00731341|Secondary|Number of Participants Discharged on Day of Cryoablation Procedure.|Per the protocol, this outcome intended to report the average duration of post operative hospital stay. However, this measurement was made very generally and was not collected in number of hours, only the dates were collected. The only actual data that can be stated is that all subjects were discharged from the hospital on the same day as the procedure. In order to report the average length of hospital stay, the wording on the outcome measure title has been changed.|Post procedure||||Participants|||Number
1466440|NCT00731341|Secondary|Time (in Days) to Return to Normal Activity|The number of days needed to return to normal activity was assessed by the participant and reported to the investigator. The response was documented at follow-up.|4 weeks post procedure||||Days||Full Range|Mean
1466441|NCT00731341|Secondary|Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient|Hysteroscopic cryoablation related pain will be measured by self reported pain severity Visual Analogue Scale (VAS) from a scale of 1 (no pain) to 10 (very severe pain) completed by the patient|Prior to hospital discharge (less than 24 hours post-procedure)||||Units on a scale from 1 to 10||Full Range|Mean
1466442|NCT00731341|Primary|Number of Adverse Events|Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)|up to 4 weeks post procedure.||||Participants|||Number
1466443|NCT00731211|Secondary|Progression-free Survival|Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|every 8 weeks until progressive disease, expected average of 18 months||||months||95% Confidence Interval|Median
1466444|NCT00731211|Primary|Overall Response Rate|Proportion of patients with complete and partial response (CR and PR). CR defined as disappearance of target lesions; PR defined as at least a 30% decrease in the sum of the longest diamater of target lesions.|18 months||||percentage of patients||95% Confidence Interval|Number
1466445|NCT00731198|Secondary|Side Effects||Intra-procedure and 24 hours after ERCP|||||||
1466446|NCT00731198|Secondary|Frequency of Post-ERCP Complications||48 hours after ERCP|||||||
1466447|NCT00731198|Secondary|Percentage of Successful Selective Cannulation||Intra-procedure|||||||
1466448|NCT00731198|Secondary|Cannulation Time||Intra-procedure|||||||
1466449|NCT00731198|Primary|The Grades of the Number of Duodenal Contractions|a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.|Intra-procedure||||scores on a scale||Standard Deviation|Mean
1466498|NCT00730964|Primary|The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.|A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.|Within 24 hours post contrast administration||||Serious Adverse Reactions|||Number
1466451|NCT00731133|Primary|Side Effects Checklist|It consists of 25 items describing side effects specific to disulfiram alone or combined with alcohol or cocaine that are rated on a scale from 0 (not at all) to 4 (very much). Total scores range from 0 (minimum) to 100 (maximum). Data were entered into a mixed model ANOVA in order to determine whether scores significantly changed over time. A slope and standard deviation describing this change over time were generated and used as our outcome measures.|Weekly for six weeks|Those who received more than one dose of disulfiram and/or completed more than one set of assessments during the protocol. Of the 15 participants who entered the study, one participant only attended clinic one day and so data were analyzed for 14 participants.|||units on a scale||Standard Deviation|Least Squares Mean
1466452|NCT00731120|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
1466453|NCT00731120|Secondary|Change From Baseline in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst). LS means were from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Full analysis set with a Baseline SF-36 measurement; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1466454|NCT00731120|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full analysis set with available data at Baseline; LOCF was used.|||scores on a scale||Standard Error|Least Squares Mean
1466455|NCT00731120|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) Scales|The HAD scale is completed by the participant and comprises two subscales, one measuring depression (focusing on the state of lost interest and diminished pleasure response) and one measuring anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Each subscale is made up of 7 items that are assessed on a scale of 0 = no anxiety/depression to 3 = severe feeling of anxiety/depression. Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores for the depression and anxiety subscales are summed separately and not combined, with each score ranging from 0 to 21 (maximal severity). LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 4 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1466456|NCT00731120|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from an ANCOVA model adjusting for Baseline score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466457|NCT00731120|Secondary|Clinical Global Impression Scale-Global Improvement (CGI-I) at Each Week Assessed|The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model adjusting for Baseline CGI-S score, center, and treatment.|Baseline and Weeks 1, 2, 4, 6 and 8.|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466458|NCT00731120|Secondary|Percentage of Participants in HAM-A Remission at Week 8|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
1466459|NCT00731120|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as a participant with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Week 8|Full analysis set; LOCF was used.|||percentage of participants|||Number
1466499|NCT00730925|Secondary|Summary of Pre-dose Concentrations of Afatnib in Plasma|Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)|Day 15, 29 and 57|Patients with no data available for the relevant parameter and dose were excluded from analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1466460|NCT00731120|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from an ANCOVA model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466461|NCT00731120|Primary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from an analysis of covariance (ANCOVA) model with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) was used.|||scores on a scale||Standard Error|Least Squares Mean
1466462|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 12|Month 12||||meters||Standard Deviation|Mean
1466463|NCT00731094|Secondary|Physical Function: 6MWD|Physical Function: 6MWD measured at Month 6|Month 6||||meters||Standard Deviation|Mean
1466464|NCT00731094|Secondary|Physical Function: 6-Minute Walking Distance (6MWD)|Physical Function: 6MWD in meters measured at Month 0|Month 0||||meters||Standard Deviation|Mean
1466465|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 12||||scores on a scale||Standard Deviation|Mean
1466466|NCT00731094|Secondary|HRQL: SF-36 MCS|HRQL: SF-36 MCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 6||||scores on a scale||Standard Deviation|Mean
1466467|NCT00731094|Secondary|HRQL: SF-36 Mental Component Summary Measure (MSC)|HRQL: SF-36 MCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The MCS aggregates the scales for vitality, mental health, social functioning, and role limitations due to personal or emotional problems.|Month 0||||scores on a scale||Standard Deviation|Mean
1466468|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 12. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 12||||scores on a scale||Standard Deviation|Mean
1466469|NCT00731094|Secondary|HRQL: SF-36 PCS|HRQL: SF-36 PCS measured at Month 6. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 6||||scores on a scale||Standard Deviation|Mean
1466671|NCT00729859|Secondary|Luteinizing Hormone Concentration (LH)||Baseline, Day 28|The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.|||IU/L||Standard Deviation|Mean
1466470|NCT00731094|Secondary|Health Related Quality of Life (HRQL): Short Form 36 Health Survey Questionnaire (SF-36) Physical Component Summary Measure (PCS)|HRQL: SF-36 PCS measured at Month 0. The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The 8 scales are the weighted sums of the 2-10 questions in their section. Norm-based scoring, where each scale and component summary measures were scored to have the same average (50) and the same standard deviation (10 points), was used for reporting results in this study. Scores are interpreted as the lower the score the more disability; conversely, the higher the score the less disability. The PCS aggregates the scales for bodily pain, general health perceptions, physical functioning, and role limitation due to physical health problems.|Month 0||||scores on a scale||Standard Deviation|Mean
1466471|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
1466472|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
1466473|NCT00731094|Secondary|Triglycerides|Triglycerides measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
1466474|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
1466475|NCT00731094|Secondary|HDL Cholesterol|HDL cholesterol measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
1466476|NCT00731094|Secondary|High-density Lipoprotein (HDL) Cholesterol|HDL cholesterol in milligrams/deciliter (mg/dL) measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
1466477|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 12|Month 12||||mg/dL||Standard Deviation|Mean
1466478|NCT00731094|Secondary|LDL Cholesterol|LDL cholesterol measured at Month 6|Month 6||||mg/dL||Standard Deviation|Mean
1466479|NCT00731094|Secondary|Low-density Lipoprotein (LDL) Cholesterol|LDL cholesterol in milligrams per deciliter (mg/dL) measured at Month 0|Month 0||||mg/dL||Standard Deviation|Mean
1466480|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 12|Month 12||||mmHg||Standard Deviation|Mean
1466481|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 6|Month 6||||mmHg||Standard Deviation|Mean
1466482|NCT00731094|Secondary|Diastolic BP|Diastolic BP measured at Month 0|Month 0||||mmHg||Standard Deviation|Mean
1466483|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 12|Month 12||||mmHg||Standard Deviation|Mean
1466484|NCT00731094|Secondary|Systolic BP|Systolic BP measured at Month 6|Month 6||||mmHg||Standard Deviation|Mean
1466485|NCT00731094|Secondary|Systolic Blood Pressure (BP)|Systolic BP in millimeters of mercury (mmHg) measured at Month 0|Month 0||||mmHg||Standard Deviation|Mean
1466486|NCT00731094|Secondary|Weight|Weight in kilograms measured at Month 12|Month 12||||kg||Standard Deviation|Mean
1466487|NCT00731094|Secondary|Weight|Weight in kilograms at measured at Month 6|Month 6||||kg||Standard Deviation|Mean
1466488|NCT00731094|Secondary|Weight|Weight in kilograms (kg) measured at Month 0|Month 0||||kg||Standard Deviation|Mean
1466489|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 71 of 98 in Physical Activity Intervention Group and 74 of 105 in Attention Control Group at Month 12|Month 12||||participants|||Number
1466490|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 77 of 101 in Physical Activity Intervention Group and 76 of 107 in Attention Control Group in Month 6|Month 6||||participants|||Number
1466491|NCT00731094|Primary|Moderate Intensity Physical Activity: Accelerometer|Participants with an average of at least 30 minutes/day of moderate intensity or greater physical activity in a subset of the study population for whom accelerometer data were obtained: 97 of 116 in Physical Activity Intervention Group and 103 of 116 in Attention Control Group at Month 0|Month 0||||participants|||Number
1466492|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 12 as measured with the modified CHAMPS Questionnaire|Month 12||||participants|||Number
1466493|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified CHAMPS Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 6 as measured with the modified CHAMPS Questionnaire|Month 6||||participants|||Number
1466494|NCT00731094|Primary|Moderate Intensity Physical Activity: Modified Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire|Participants achieving 150 minutes/week of moderate intensity or greater physical activity at Month 0 as measured with the modified CHAMPS Questionnaire|Month 0||||participants|||Number
1466495|NCT00731055|Primary|Cigarette Choice|Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.|During each of the four weekly 6-hour experimental sessions||||number of cigarette choices (0-9)||Standard Deviation|Mean
1466496|NCT00731042|Primary|Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days|Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly).|Baseline and 14 days|Analysis was done per protocol|||units on a scale||Standard Deviation|Mean
1466497|NCT00730964|Secondary|The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.|The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.|Within 24 hours post contrast administration||||Serious adverse events|||Number
1466672|NCT00729859|Secondary|Follicle Stimulating Hormone (FSH)||Baseline, 28 days|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||IU/L||Standard Deviation|Mean
1466501|NCT00730925|Secondary|Percentage of Participants With Disease Control (DC)|Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
1466502|NCT00730925|Primary|Percentage of Participants With Best Objective Response|Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.|Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks thereafter.|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
1466503|NCT00730912|Primary|Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.|||ng•hr/mL||Standard Deviation|Mean
1466504|NCT00730912|Primary|Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117)|SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method.|After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed|Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104.|||ng/mL||Standard Deviation|Mean
1466505|NCT00730886|Secondary|Health Care Costs||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466506|NCT00730886|Secondary|Medical Outcomes Study 36-Item Short Form Survey||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466507|NCT00730886|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466508|NCT00730886|Secondary|Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466509|NCT00730886|Secondary|C-Section Rate||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466510|NCT00730886|Secondary|Time to Conception||Post-treatment|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466511|NCT00730886|Secondary|Miscarriage Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466512|NCT00730886|Secondary|Term Delivery Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466513|NCT00730886|Secondary|Pregnancy Rate||Between the 3 and 15-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466514|NCT00730886|Primary|Live Birth Rate||Between the 3 and 9-month post-treatment visits|enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.||||||
1466515|NCT00730847|Primary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.|During the entire study period (from Day 0 up to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.|||Participants|||Count of Participants
1466543|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Week 8|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Week 8|Full analysis set; Last observation carried forward (LOCF) was used.|||percentage of participants|||Number
1466516|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.|||Participants|||Count of Participants
1466517|NCT00730847|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0°C.|During the 7-day follow-up period (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.|||Participants|||Count of Participants
1466518|NCT00730847|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.|||Participants|||Count of Participants
1466519|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466520|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466521|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466522|NCT00730756|Secondary|Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)|The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466523|NCT00730756|Secondary|Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466524|NCT00730756|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)|The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466525|NCT00730756|Secondary|Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)|Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466587|NCT00730275|Secondary|Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Cmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||nM||95% Confidence Interval|Geometric Mean
1466526|NCT00730756|Secondary|Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)|The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment.|Baseline through Week 4 (28 days)|ITT Population|||points on a scale||Standard Error|Least Squares Mean
1466527|NCT00730756|Primary|Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)|The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.|Baseline through Week 4 (28 days)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication|||points on a scale||Standard Error|Least Squares Mean
1466528|NCT00730730|Secondary|Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.|"Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) > 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI.~An ABI ≥ 0.90 is considered normal."|From baseline up to 30-days|Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb|||limbs|Participants||Number
1466529|NCT00730730|Secondary|Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.|"Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up-~Category 0: Asymptomatic, no hemodynamically significant occlusive disease;~Category 1: Mild claudication;~Category 2: Moderate claudication;~Category 3: Severe claudication;~Category 4: Ischemic rest pain;~Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia;~Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable"|From baseline up to 30-days|Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs|||limbs|Participants||Number
1466530|NCT00730730|Secondary|Number of Participants With Acute Success|angiographic evidence of < 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)|from after stent placement to prior to hospital discharge (up to 3 days)|Intent to Treat population(ITT); missing angiographic data for one patient|||participants|||Number
1466531|NCT00730730|Primary|The Number of Participants With Major Adverse Events (MAE)|Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry|30 days|Intent-to-treat population (ITT)|||participants|||Number
1466532|NCT00730691|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors the participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 8|Full analysis set|||participants|||Number
1466533|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Depression Subscale at All Weeks Assessed|The HAD-Depression subscale is completed by the participant and measures depression, focusing on the state of lost interest and diminished pleasure response. The subscale is made up of 7 items that are assessed on a scale from 0 (no depression) to 3 (severe feeling of depression). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. The item scores are summed and the total subscore ranges from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) model with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 4 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466534|NCT00730691|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4, 6 and 8|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466535|NCT00730691|Secondary|Percentage of Participants in HAM-A Remission at Each Week Assessed|Remission is defined as a Hamilton Anxiety Scale (HAM-A) total score ≤ 7. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Weeks 1, 2, 4, 6 and 8|"Full analysis set. LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1466738|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dryness Strata)||12 weeks|ITT; LOCF|||pH||Standard Deviation|Mean
1466536|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to weeks 1, 2, 4 and 6|"Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466537|NCT00730691|Secondary|Percentage of Responders in HAM-A Total Score at Other Weeks Assessed|Response was defined as participants with a ≥50% decrease from Baseline in the HAM-A total score. The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (symptoms absent) to 56 (maximum severity).|Baseline and Weeks 1, 2, 4 and 6|"Full analysis set; LOCF was used. n indicates the number of patients included in the analysis at each time point."|||percentage of participants|||Number
1466538|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Other Weeks Assessed|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466539|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Other Weeks Assessed|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466540|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Other Weeks Assessed|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1 and 4|"Full analysis set with available data at Baseline. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466541|NCT00730691|Secondary|Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Other Weeks Assessed|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Weeks 1, 2, 4 and 6|"Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used; n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Error|Least Squares Mean
1466542|NCT00730691|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score at Week 8 in Participants With Baseline HAM-A ≥25|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set patients with a HAM-A Baseline score ≥25. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1466554|NCT00730639|Secondary|Duration of Tumor Response|Duration of tumor response (DOR) was calculated from the first date of response of complete response (CR) or partial response (PR) to the date of the first progressive disease (PD) or the date of death. Duration of response was censored at the last tumor assessment date if a responder did not have PD or death. Nonresponders were not included in the analysis. Median DOR was estimated by Kaplan-Meier analysis.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with a measurable tumor response were analyzed.|||months||Full Range|Median
1466544|NCT00730691|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) at Week 8|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1466545|NCT00730691|Secondary|Mean Clinical Global Impression Scale-Global Improvement (CGI-I) at Week 8|The Clinical Global Impression - Global Improvement scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1466546|NCT00730691|Secondary|Change From Baseline in Hospital Anxiety and Depression (HAD) - Anxiety Subscale at Week 8|The HAD-Anxiety subscale is completed by the participant and measures anxiety, including anxious mood, restlessness, anxious thoughts, and panic attacks. The subscale is made up of 7 items that are assessed on a scale from 0 (no anxiety) to 3 (severe feeling of anxiety). Participants are required to indicate the response which most accurately reflects the way they have felt over the last few days. Scores are summed and range from 0 to 21 (maximal severity). LS means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|Full analysis set. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1466547|NCT00730691|Primary|Change From Baseline in the Hamilton Anxiety (HAM-A) Scale Total Score at Week 8|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56 where <17 indicates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Least Squares (LS) means were from a mixed model for repeated measurements (MMRM) with week, Baseline score-by-week and treatment-by-week interaction as factors.|Baseline to Week 8|The full analysis set (FAS) included all randomized patients who received at least 1 dose of study drug, and had at least 1 postbaseline value for assessment of primary efficacy. A mixed model for repeated measurements (MMRM) based on observed cases was used.|||scores on a scale||Standard Error|Least Squares Mean
1466548|NCT00730639|Secondary|Mean Effective Half-life (T-HALFeff)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of T-HALFeff was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||hours (h)||Standard Deviation|Mean
1466549|NCT00730639|Secondary|Geometric Mean Total Body Clearance of Drug From Serum (CLT)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples Blood samples were assessed at all doses from a subset of participants. The PK parameter of CLT was measured in milliliters per hour (mL/h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycle 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||milliliters per hour (mL/h)||Geometric Coefficient of Variation|Geometric Mean
1466550|NCT00730639|Secondary|Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed at all doses from a subset of participants. The PK parameter of AUC was measured in micrograms*hours per milliliter (μg*h/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||micrograms*hours per milliliter (μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
1466551|NCT00730639|Secondary|Median Time of Maximum Serum Concentration (Tmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated ELISA. Blood samples were assessed Blood samples were assessed at all doses from a subset of participants. The PK parameter of Tmax was measured in hours (h).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||hours (h)||Full Range|Median
1466552|NCT00730639|Primary|Number of Participants With Abnormal Hematology Laboratory Values|Hemoglobin, Lymphocytes, Neutrophils, Platelets and Leukocytes. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for Hemoglobin were based on Gr 1: 10.0 - less than (<) lower limit of normal (LLN); Gr 2: 8.0 - < 10.0; Gr 3: 6.5 - < 8.0; Gr 4: < 6.5. Abnormal values for Lymphocytes were based on Gr 1: 0.8 - < 1.5; Gr 2: 0.5 - < 0.8; Gr 3): 0.2 - < 0.5; Gr 4: < 0.2. Abnormal values for Neutrophils were based on Gr 1: 1.5 - < 2.0; Gr 2: 1.0 - < 1.5; Gr 3: 0.5 - < 1.0; Gr 4: < 0.5. Abnormal values for Platelets were based on Gr 1: 75.0 - < lower limits of normal (LLN); Gr 2: 50.0 - < 75.0; Gr 3: 25.0 - < 50.0; Gr 4: < 25.0. Abnormal values for Leukocytes were based on Gr 1: 3.0 - < LLN; Gr 2: 2.0 - < 3.0; Gr 3: 1.0 - < 2.0; Gr4: < 1.0.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.|||participants|||Number
1466553|NCT00730639|Secondary|Geometric Mean Maximum Serum Concentration (Cmax)|Nivolumab in human serum was assayed by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA). Blood samples were assessed at all doses from a subset of participants. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).|1,4,8,24,48 and 96 hours post-dose timepoints on Day 1 of cycles 1 and 3|All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1466555|NCT00730639|Secondary|Objective Response Rate|Tumor response was evaluated by the sponsor based on tumor assessments by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate (ORR) was defined as the proportion of participants who's confirmed best overall response (BOR) is either complete (CR) or partial (PR), where the denominator is the number of treated participants in the population of interest. Response was based on tumor measurements. Responders= complete response (CR) or partial response (PR). CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter. 95% Confidence intervals (CIs) were computed using the Clopper Pearson method.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab with an evaluable tumor response were analyzed.|||percentage of participants||95% Confidence Interval|Number
1466556|NCT00730639|Secondary|Immunogenicity Assessment|Classification of participants host immune response was based on the following definitions: Anti-Drug Antibody (ADA) Positive Subjects have with at least one ADA positive sample at any time after initiation of treatment. ADA positive subjects were further classified into categories with Persistent Positive defined as an ADA positive sample at 2 or more sequential timepoints at least 8 weeks apart.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab and were ADA-evaluable were analyzed.|||participants|||Number
1466557|NCT00730639|Primary|Number of Participants With Abnormal Serum Chemistry Laboratory Values|Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine and Total Bilirubin. National Cancer Institute Common Terminology Criteria (CTC) version (v) 3.0 was used to determine Grade (Gr). Abnormal values for ALP, ALT and AST were based on grades; Gr 1: > 1.0 - 2.5 * upper limits of normal (ULN); Gr 2: > 2.5 - 5.0 * ULN; Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Abnormal values for Creatinine were based on Gr 1: > 1.0 - 1.5*ULN; Gr 2: > 1.5 - 3.0*ULN; Gr 3: > 3.0 - 6.0*ULN; Gr 4: > 6.0*ULN. Abnormal values for Total Bilirubin were based on Gr 1: > 1.0 - 1.5 * upper limits of normal (ULN); Gr 2: > 1.5 - 3.0 * ULN; Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN.|Day 1 up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab who underwent the laboratory test.|||participants|||Number
1466558|NCT00730639|Primary|Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 to 70 days following last dose of study drug up to June 2013, approximately 4 years|All participants who received at least 1 dose or any partial dose of nivolumab were analyzed.|||participants|||Number
1466559|NCT00730483|Secondary|Symptomatic Response by Assessing Symptom Severity in Patients|"Symptomatic response not assessed due to premature termination of study.~Scoring system for assessing symptom severity in patients with neuroendocrine/carcinoid syndrome was as follows:~- No symptoms - Patient completely asymptomatic~- Mild symptoms - Patient with symptoms of diarrhea, flushing, or asthma up to 4 times weekly~- Symptoms impact daily living - symptoms of diarrhea, flushing, or asthma up 5-7 weekly~- Severe symptoms - multiple daily symptoms of diarrhea, flushing, or asthma; symptoms require significant reorganization of daily activities~- Disabling symptoms - Patient disabled by multiple attacks and severe symptoms; unable to leave home or requires hospitalization"|Duration of study participation, average of 12 months|||||||
1466560|NCT00730483|Secondary|Biochemical Response - Time to Progression|Biochemical response not assessed due to premature termination of study.|Time to progression, 12 months|||||||
1466561|NCT00730483|Secondary|Survival|Survival outcomes not assessed due to premature termination of study.|overall survival|||||||
1466562|NCT00730483|Secondary|Tumor Response (Efficacy) - by Response Evaluation Criteria in Solid Tumors (RECIST) and the European Association for the Study of the Liver (EASL) Criteria|"Study was terminated and full outcome not assessed. The results below are based on 13 patients at 1 month post DEB-TACE, 10 patients at 6 months, and 6 patients at 12 months.~RECIST:~Complete Response (CR): Disappearance of all targeted lesions Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of targeted lesions Progressive Disease (PD): At least 20% increase in the sum of LD of targeted lesions Stable Disease (SD): Cases that are not applicable for PD or PR.~EASL:~CR: Absence of any enhancement in target lesion PR: Greater than 50% decrease from baseline enhancement in target lesion PD: Greater than 25% increase in target lesion SD: All other cases"|12 months|13 patients were analyzed for 1 month post-treatment; 10 patients for 6 months post-treatment; and 6 patients at the 12 month post-treatment time point.|||Participants|||Count of Participants
1466563|NCT00730483|Primary|Safety - Number of CTCAE v3.0 Events 1 Month Post DEB-TACE|Safety was assessed at each DEB-TACE procedure and at every follow-up thereafter according to National Cancer Institute Common Toxicity Criteria (CTCAE) v3.0. The study was prematurely terminated due to high incidence of biloma and liver abscess. Safety data below is based off of 13 patients enrolled on protocol at 1 month post initial treatment.|1 month after initial DEB-TACE treatment||||number of adverse events|||Number
1466564|NCT00730405|Secondary|The Percentage of Participants With a Global Change Score of Cleared or Much Improved at Week 52|A count of the number of toenails affected, using visual examination, was performed at all study visits (Week 12, 24, 30, 36, 44 and 52). The investigator given a global evaluation of the toenails condition, based on the investigator’s assessment of the reduction in extent of nail involvement and improvement in clinical signs as compared with the status at the Baseline visit. The 0-5 rating scale was used: 0: cleared, 1: much improved, 2: minimally improved, 3: unchanged, 4: minimally worse and 5: much worse; where higher score indicates worse condition and lower score indicates clear toenail.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1466565|NCT00730405|Secondary|Absolute Change in Unaffected Part of Target Nail From Baseline to Week 52|Length of the unaffected part of the target nail was measured in millimeters along the midpoint from the nail fold to the proximal border of the affected part (lowest point affected) along the midpoint of the target nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52. Baseline values were the observations at Week 0/Day 1 or before. Change from Baseline was a Baseline value subtracted from Week 52 value. P-value was based on analysis of variance (ANOVA) with treatment and pooled center. Statistics is provided for adjusted least square mean.|Baseline (Week 0/Day 1 or before) and up to Week 52|ITT analysis set. All participants were available at the time of assessment.|||Millimeters||Standard Deviation|Mean
1466566|NCT00730405|Secondary|The Percentage of Participants Who Achieve Complete Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Complete cure was defined as mycological cure plus clinical cure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1466567|NCT00730405|Secondary|The Percentage of Participants Who Achieve Mycological Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Mycological cure was defined as negative potassium hydroxide (KOH) and negative cultures for dermatophytes. It was assessed on Week 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1466568|NCT00730405|Secondary|The Percentage of Participants Who Achieve Clinical Cure at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Clinical cure was defined as 100% clear nail. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|ITT analysis set. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1466569|NCT00730405|Primary|The Percentage of Participants Who Achieve Effective Treatment at Week 52|At each study visit, the investigator assessed the percentage of affected toenail on the target nail by estimating the percent affected nail in each quadrant, summing the percent affected in each quadrant and dividing the sum by 4. Effective treatment was defined as a mycological cure and clear or almost clear nail (distal subungual hyperkeratosis and/or onycholysis leaving less than 10% of nail plate effected). Comparisons were carried out in a sequential step-down fashion, combined with the Holm procedure at step 2. P-value was based on a sequential step-down combined with the Holm procedure. It was assessed on Week 4, 8, 12, 16, 20, 24, 30, 36, 44 and 52.|Week 52|The intent-to-treat (ITT) analysis set consists of all randomized participants who receive study product. All participants were available at the time of assessment.|||Percentage of participants||95% Confidence Interval|Number
1466570|NCT00730353|Secondary|Toxicity Profile|Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.|16 months||||instances of adverse event|||Number
1466571|NCT00730353|Secondary|Progression-Free Survival|To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|12 months|Intention-to-treat patients|||Days||90% Confidence Interval|Median
1466572|NCT00730353|Secondary|Overall Survival|To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma|12 months|All participants on an intent-to-treat basis|||percentage of participants||90% Confidence Interval|Median
1466573|NCT00730353|Secondary|Response Rate|To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.|6 months|Evaluable patients, as previously defined.|||percentage of participants||90% Confidence Interval|Number
1466574|NCT00730353|Primary|Progression Free Survival Rate at 24 Weeks|To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|24 weeks|Intent to treat - all enrolled participants|||percentage of participants||90% Confidence Interval|Number
1466575|NCT00730327|Post-Hoc|Percent Total Body Weight Loss (%TBWL)|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).|||percentage of TBWL||95% Confidence Interval|Mean
1466576|NCT00730327|Post-Hoc|Percent EWL (Using BMI=25 kg/m²)|"Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)|||percentage of EWL||Standard Deviation|Mean
1466586|NCT00730275|Secondary|Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin|Serum samples were used to determine the Tmax for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||hours||Full Range|Median
1466577|NCT00730327|Post-Hoc|Change in BMI|Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).|||kg/m²||Standard Deviation|Mean
1466578|NCT00730327|Secondary|Change in Participant Depression (Beck Depression Inventory II)|Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)|||units on a scale||Standard Deviation|Mean
1466579|NCT00730327|Secondary|Change in Quality of Life (IWQOL-Lite)|The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on questionnaire at both timepoints).|||units on a scale||Standard Deviation|Mean
1466580|NCT00730327|Secondary|Change in Quality of Life (SF-36)|The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.|Baseline, Week 39|Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).|||units on a scale||Standard Deviation|Mean
1466581|NCT00730327|Secondary|Percent of Participants With Comorbid Conditions|"The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline.~Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL.~Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic.~Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL <50 mg/dL (male) or <40 mg/dL (female)."|Baseline, Week 26, Week 39, Week 52|Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).|||percentage of participants|||Number
1466582|NCT00730327|Primary|Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group|"The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group.~%EWL= (weight loss divided by excess weight) * 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight.~Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table."|9 months|Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).|||percentage of BIB participants||95% Confidence Interval|Number
1466583|NCT00730327|Primary|Mean Percent Excess Weight Loss (%EWL)|"The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint.~Percent EWL was calculated as %EWL= (weight loss divided by excess weight)*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight."|9 months|Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).|||percentage of EWL||Standard Deviation|Mean
1466584|NCT00730275|Secondary|Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo|"Plasma DPP-4 activity was analyzed using the 24-hour weighted average inhibition (WAI) and percent inhibition at 24 hours post-dose.~WAI was defined as the AUC of inhibition divided by the length of the post-dose time interval. Positive values of WAI represent a decrease in DPP-4 activity."|Pre-dose through 24 hours post-dose|All participants who received a single dose of sitagliptin or placebo.|||Percent inhibition||95% Confidence Interval|Least Squares Mean
1466585|NCT00730275|Secondary|Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin|Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||hours||Standard Deviation|Mean
1466588|NCT00730275|Primary|Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin|Serum samples were used to determine the AUC from time 0 to infinity for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.|Pre-dose through 72 hours post-dose|All participants who received a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.|||nM*hour||95% Confidence Interval|Geometric Mean
1466589|NCT00730275|Primary|Number of Participants Who Experienced at Least One Adverse Event||Pre-study through 10 to 14 days following administration of study drug|All enrolled participants.|||participants|||Number
1466590|NCT00730236|Secondary|Absolute Change From Baseline in Weight|Absolute change from Baseline in weight|Baseline and Week 78|All patients treated|||kg||Standard Deviation|Mean
1466591|NCT00730236|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and Week 78|All patients treated|||mg/dL||Standard Deviation|Mean
1466592|NCT00730236|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and Week 78|All patients treated|||U/L||Standard Deviation|Mean
1466593|NCT00730236|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and Week 78|All patients treated|||U/L||Standard Deviation|Mean
1466594|NCT00730236|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and Week 78|All patients treated|||Percent Hepatic Fat||Standard Deviation|Mean
1466595|NCT00730236|Secondary|Percent Change From Baseline in Apolipoprotein AI (Apo AI)|Percent change from Baseline in Apo AI|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1466596|NCT00730236|Secondary|Percent Change From Baseline in Non-HDL-C|Percent change from Baseline in non-HDL-C|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1466597|NCT00730236|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Percent change from Baseline in HDL-C|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Median
1466598|NCT00730236|Secondary|Percent Change From Baseline in Triglycerides|Percent change from Baseline in triglycerides|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1466599|NCT00730236|Secondary|Percent Change From Baseline for Apolipoprotein B (Apo B)|Percent change from Baseline for Apo B|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1466600|NCT00730236|Secondary|Percent Change From Baseline in Total Cholesterol (TC)|Percent change from Baseline in TC|Baseline and Week 26|ITT Population|||Percent Change||Standard Deviation|Mean
1466601|NCT00730236|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Percent change from Baseline in LDL-C|Baseline and Week 26|Intention To Treat (ITT) Population|||Percent Change||Standard Deviation|Mean
1466602|NCT00730171|Primary|Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)|For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.|From first dose of open-label study drug up to 78 weeks|Enrolled participants who received at least 1 dose of open-label study drug. It was identified that 1 participant enrolled twice in the study under 2 ID numbers; this participant is included as an RI participant in the CC Safety Population, and as an RO participant in both the IBS-C and Overall Safety Populations.|||Participants|||Count of Participants
1466603|NCT00730132|Primary|Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||mmol/L||Standard Deviation|Mean
1466604|NCT00730132|Primary|Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups||Visit 2 (Month 2, end of observation) and Visit 1 (Day 0, baseline)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||mmol/L||Standard Deviation|Mean
1466605|NCT00730132|Primary|Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation||Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded.|||Percentage of patients|||Number
1466606|NCT00730132|Primary|Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation|Statins included in this outcome measure included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration. 2. shift to a different (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|Visit 2 (Month 2, end of observation)|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol deviations were recorded. One subject each from the Ezetimibe and New Statin groups were excluded from this analysis due to missing data.|||Percentage of patients|||Number
1466607|NCT00730132|Primary|Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin.|Statins included: 1. statin dose (atorvastatin, fluvastatin, rosuvastatin, simvastatin) titration . 2. shift to a (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastin, simvastatin) different statin . 3. Ezetimibe added to existing statin (atorvastatin, lovastatin, rosuvastatin, simvastatin).|During the study|The efficacy analysis set (n=557) included all enrolled subjects, by treatment (after treatment modification), who received at least one dose of the modified lipid-lowering treatment and for whom no protocol violations were recorded. One subject each from ezetimibe added to existing statin and new statin group were excluded (missing data)|||Percentage of patients|||Number
1466608|NCT00730041|Secondary|Measurement of Usage (Hours) of the Continuous Positive Airway Pressure Machine as Recorded by SmartCard (Home Compliance Monitor)|The CPAP machine has an internal clock/calendar, and capabilities to record usage onto a removable data card the size of a credit card. Data is recorded from the first time the machine is turned on to the last time the machine is turned on during a given period in which the SmartCard is present in the machine. The SmartCard records all days during the given period and keeps track of days in which the CPAP machine is used and days in which it is not used. The SmartCard data is able to be downloaded to a computer for review and analysis.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.|||Average hours per day of days used||Standard Deviation|Mean
1466609|NCT00730041|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ), a Validated Measure the Impact of Excessive Sleepiness on Multiple Activities of Daily Living.|The FOSQ can assess the quality of sleep and this scale is a validated measure the impact of excessive sleepiness on multiple activities of daily living. It has 30 questions in 5 subgroups of general productivity (8 questions), social outcome (2), activity level (9), vigilance (7), and intimate relationships and sexual activity (4). Responses for each question range from 1 (extreme difficulty or low activity level) to 4 (no difficulty or high activity level) for each subgroup. A mean is calculated for each subgroup, and then the mean of the subgroups is calculated and multiplied by 5.|Baseline and 4 months post-procedure|Two subjects became lost to follow-up and did not return for the final study visit.|||Scores on a Scale||Standard Deviation|Mean
1466610|NCT00730041|Secondary|Epworth Sleepiness Scale (ESS), a Validated Measure of Daytime Sleepiness.|The Epworth Sleepiness Scale (ESS) was included in the subject questionnaire as a tool to further assess the quality of sleep for each subject throughout the follow-up period. This scale is a validated clinical indicator that quantifies the patient’s chance of falling asleep during eight different activities of daily living such as reading, talking, resting and driving. Each of the eight questions has four possible responses: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing to 3 = high chance of dozing, for a possible maximum score of 24.|Baseline and 4 months post-procedure|Two participants became lost to follow-up and did not return for the final study visit.|||Scores on a Scale||Standard Deviation|Mean
1466611|NCT00730041|Secondary|Visual Analog Scale (VAS) to Measure Continuous Positive Airway Pressure (CPAP) Satisfaction.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP satisfaction. Scores ranged from 0 (very unsatisfied) to 10 (very satisfied).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.|||Scores on a Scale||Standard Deviation|Mean
1466612|NCT00730041|Secondary|Measurement of Total Leak as Recorded by SmartCard (Home Compliance Feature of the Continuous Positive Airway Pressure Machine)|Leak is an indicator of mask/headgear fit and can also be used to substantiate or contradict an assigned therapeutic pressure. Total leak is the sum of intentional leak to prevent carbon dioxide rebreathing and unintentional leak. Each mask has a known amount of leak (the intentional leak), and subjects were instructed not to changes masks to minimize this variable. Approximate range is 0-100, and the amount of leak increases as the number increases. Average leak values are in the 20-50 liters per minute range. The CPAP machine records leak data during each night of usage and can average.|Baseline and 4 months post-procedure|Five participants in the sham group did not return their SmartCards at the final study visit.|||Units on a scale||Standard Deviation|Mean
1466613|NCT00730041|Secondary|Visual Analog Scale (VAS) for Continuous Positive Airway Pressure (CPAP) Comfort Score.|The candidate was asked to complete a questionnaire that included a VAS describing CPAP therapy comfort. Scores ranged from 0 (very uncomfortable) to 10 (very comfortable).|Baseline and 4 months post-procedure|Two participants in the sham group became lost to follow-up and did not return for the final follow-up.|||Scores on a Scale||Standard Deviation|Mean
1466614|NCT00730041|Primary|Therapeutic Pressure From a Polysomnogram (PSG) With Continuous Positive Airway Pressure (CPAP) Titration|The American Academy of Sleep Medicine’s (AASM) recommended treatment for patients with obstructive sleep apnea (OSA) is Continuous Positive Airway Pressure (CPAP), which is a life-long therapy that requires subjects to wear a nasal or facial mask connected to a portable airflow generator while sleeping. CPAP therapy is intended to prevent collapse of the upper airway. CPAP pressures are measured in centimeters of water, and range in whole numbers from 4cm H2O to 20cm H2O. The therapeutic pressure is usually determined during overnight polysomnography and usually performed by a technician.|Baseline and 3 months post-procedure|50 of 51 total participants returned to the sleep lab for the 90-day PSG. All 50 participants are part of the primary endpoint analysis.|||centimeters of water (cm H2O)||Standard Deviation|Mean
1466615|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|All participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
1466626|NCT00730015|Secondary|12-week Change in Severity of Straining|"Severity of Straining is measured on a 5-point scale, where a value of 1 is not at all and a value of 5 is an extreme amount."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1466616|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.|OMFU visit|The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.|||percentage of participants||95% Confidence Interval|Number
1466617|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|All participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
1466618|NCT00730028|Secondary|Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.|Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.|EOT visit within 48 hours of completion of therapy|The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.|||percentage of participants||95% Confidence Interval|Number
1466619|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The ITT population was comprised of all participants enrolled in the trial.|||percentage of participants||95% Confidence Interval|Number
1466620|NCT00730028|Secondary|Number of Participants Reporting Adverse Events That Are Treatment Limiting.|Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.|||participants|||Number
1466621|NCT00730028|Secondary|Number of Participants Reporting Adverse Events.|Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.|End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)|Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.|||participants|||Number
1466622|NCT00730028|Primary|Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.|"Clinical failure is defined as the occurence of any of the following:~Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.~Occurrence of a SSTI at another site other than the site(s) under study.~Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.~Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.~Unplanned surgical procedure for the infection under study at any time through the TOC visit.~Hospitalization for treatment of active or invasive infection at any time through the TOC visit."|Test of cure (TOC) (7-10 days after completion of therapy)|The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.|||percentage of participants||95% Confidence Interval|Number
1466623|NCT00730015|Secondary|12-week Change in Constipation Severity|"Constipation severity was based on a 5-point ordinal scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 10 patients who dropped out prior to finishing 1 week of the trial have missing data. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1466624|NCT00730015|Secondary|12-week Change in Bloating|"Bloating was based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1466625|NCT00730015|Secondary|12-week Change in Abdominal Discomfort|"Abdominal discomfort is based on a 5-point scale where a value of l is none and a value of 5 is very severe."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1466665|NCT00729859|Secondary|Fasting Serum Insulin||Baseline, Day 28, Day 56|per protocol|||picomolar||Standard Deviation|Mean
1466627|NCT00730015|Secondary|12-week Change in Stool Consistency|"The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]"|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.|||units on a scale||Standard Error|Least Squares Mean
1466628|NCT00730015|Secondary|12-Week Spontaneous Bowl Movement (SBM) Frequency|The number of SBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||SBMs per Week||Standard Error|Least Squares Mean
1466629|NCT00730015|Secondary|12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency|The number of CSBMs per week.|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.|||CSBMs per Week||Standard Error|Least Squares Mean
1466630|NCT00730015|Primary|Complete Spontaneous Bowel Movement (CSBM) Overall Responder|"A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.~An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Change from Baseline to Week 12|643 randomized patients received at least 1 dose of study drug. 642 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.|||participants|||Number
1466631|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466632|NCT00729937|Secondary|Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466633|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Intent to Treat Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|All subjects who took at least one dose of study medication were included in the intent to treat population.|||days||Standard Deviation|Mean
1466634|NCT00729937|Secondary|Mean Days Missed From Normal Activities in the Per Protocol Population|As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.|Day 1 through 14|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||days||Standard Deviation|Mean
1466635|NCT00729937|Secondary|Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class|All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466636|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466666|NCT00729859|Secondary|Homeostasis Model of Insulin Resistance (HOMA-IR)|HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol|||HOMA score||Standard Deviation|Mean
1466667|NCT00729859|Secondary|Quantitative Insulin Sensitivity Check Index (QUICKI)|QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.|Baseline, Day 28, Day 56|per protocol|||QUICKI index||Standard Deviation|Mean
1466637|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466638|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466639|NCT00729937|Secondary|Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population|At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466640|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466641|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466642|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466643|NCT00729937|Secondary|Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population|Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466644|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466645|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466646|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466668|NCT00729859|Secondary|Sex Hormone Binding Globulin (SHBG)||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||nmol/L||Standard Deviation|Mean
1466669|NCT00729859|Secondary|Estradiol Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.|||pmol/L||Standard Deviation|Mean
1466647|NCT00729937|Secondary|Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population|Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466648|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466649|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.|Day 1 through Day 49-63|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466650|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466651|NCT00729937|Secondary|Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population|All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.|Day 1 through Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466652|NCT00729937|Secondary|Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466653|NCT00729937|Secondary|Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population|Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.|Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466654|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466670|NCT00729859|Secondary|Testosterone Concentration||Baseline, Day 28|Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.|||nmol/L||Standard Deviation|Mean
1466739|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dryness Strata)||12 weeks|ITT; LOCF|||percentage of superficial cells||Standard Deviation|Mean
1466655|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466656|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466657|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 8-10|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466658|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466659|NCT00729937|Secondary|Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population|The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.|Day 1 to Day 3-4|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466660|NCT00729937|Primary|Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.|||participants|||Number
1466661|NCT00729937|Secondary|Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population|Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.|Days 14-21|All subjects who took at least one dose of study medication were included in the intent to treat population.|||participants|||Number
1466662|NCT00729924|Secondary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.|This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL).|Day 7||||ratio||Inter-Quartile Range|Median
1466663|NCT00729924|Primary|Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.|The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL).|Day 7||||1/h||Inter-Quartile Range|Median
1466664|NCT00729859|Secondary|Fasting Lipid Levels||Baseline, Day 28, Day 56|per protocol|||mmol/L||Standard Deviation|Mean
1466673|NCT00729859|Primary|Endothelial Progenitor Cells|Number of CD33 + CD134+ cells as a percentage of all lymphocytes|Baseline, Day 28|Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed|||percentage of all lymphocytes||Standard Deviation|Mean
1466674|NCT00729846|Primary|Visual Acuity: Percentage of Patients Losing 3 or More Lines(15 Letters) of Visual Acuity From Baseline.||1 Year||||percent of participants|||Number
1466675|NCT00729833|Secondary|Number of Participants With Objective Response (OR)|Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||participants|||Number
1466676|NCT00729833|Secondary|Number of Participants With Anti-Drug Antibodies (ADA)|Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.|0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)|ADA Analysis Set: Participants who started treatment with study medication and provided at least 1 on-study ADA sample. Due to early termination of the study, ADA samples were not assayed.||||||
1466677|NCT00729833|Secondary|Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib||24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1466678|NCT00729833|Secondary|Trough Plasma Concentration (Ctrough) of Sunitinib||0.5 hour predose on Day 1 of Cycle 2|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1466679|NCT00729833|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib|AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).|0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1466680|NCT00729833|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||hours||Full Range|Median
1466681|NCT00729833|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib||0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD).|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
1466682|NCT00729833|Secondary|Plasma Decay Half-Life (t1/2) of Figitumumab|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||hours||Standard Deviation|Mean
1466683|NCT00729833|Secondary|Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab|AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||mg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1466684|NCT00729833|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab|AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.|0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4|PK Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||milligram*hour/milliliter (mg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
1466685|NCT00729833|Secondary|Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab||0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4|Pharmacokinetic (PK) Analysis Set: Participants who received all scheduled doses of both drugs and completed all required PK assessments in the dose expansion cohort (figitumumab 10 mg/kg + sunitinib 25 mg CDD); n=number of participants in the indicated cycle.|||milligram/liter (mg/L)||Geometric Coefficient of Variation|Geometric Mean
1466686|NCT00729833|Secondary|Percentage of Participants With Blood Chemistry Laboratory Test Abnormality|Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication; n=number of participants evaluable for this outcome measure, respectively.|||percentage of participants|||Number
1466740|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dryness Strata)||12 weeks|ITT; LOCF|||percentage of parabasal cells||Standard Deviation|Mean
1466687|NCT00729833|Secondary|Percentage of Participants With Hematologic Laboratory Test Abnormality|Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1466688|NCT00729833|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).|Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)|Safety Analysis Set: All enrolled participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1466689|NCT00729833|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|"Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (>=) 7 days delay in administration of Cycle 2.~Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Baseline up to the end of Cycle 1 (each cycle=3 weeks)|Per-Protocol Analysis Set: All participants who started treatment and who did not have first cycle major treatment deviations.|||participants|||Number
1466690|NCT00729807|Secondary|Progression Time in Patients|To observe the time to progression in these patients. However, in the six patients treated they either all had progression of disease or stable when they came off study (i.e., the drug did not work, there was no basis to collect the data to time to progression (they went on to different treatments or hospice.) One patient was inevaluable due to going on hospice, four had disease progression disease and one had stable disease and patients must come off per protocol if they do not show a response to the drug.|pre- to post-treatment||2017-04-30|04/2017||||
1466691|NCT00729807|Secondary|Pre- and Post-treatment Changes in the Concentration of S100B and p21 in Tumor Biopsy Samples|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actuallyly treated.|pre- and pos-treatment||2017-04-30|04/2017||||
1466692|NCT00729807|Secondary|Serial Serum S100B Levels|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotension and hypoglycemia in the small cohort of patients actually treated.|Days 3, 8, and 12 of Cycles 1 and 2||2017-04-30|04/2017||||
1466693|NCT00729807|Secondary|Wild-type p53 and S100B Status at Baseline|Zero participants analyzed. Data was not analyzed owing to the small number of patients actually treated with pentamidine; most patients screened could not enter owing to inability to define p53 status in a timely fashion and emergence of immunotherapeutics as an active modality in melanoma. Data Safety Monitoring board recommended closure to accrual after documentation of hypotensions and hypoglycemia in the small cohort of patients actually treated.|Baseline||2017-04-30|04/2017||||
1466694|NCT00729807|Primary|CR, PR, Stable Disease|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum of the longest diameter since the treatment started. (Therasse, P., Arbuck, S.G., Eisenhauer, E.A., Wanders, J., Kaplan, R.S., Rubinstein, J., Van Glabbeke, M., van Oosterom, A.T., Christian, M.C., Gwyther, S.G. (2000) J Natl Cancer Inst 92, 205-16)|Every 6-8 weeks||||participants|||Number
1466695|NCT00729781|Primary|Safety|Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.|During 12-week original study and at long-term follow-up of 11 months or longer|All enrolled subjects' adverse events were collected.|||events|||Number
1466696|NCT00729781|Primary|Cosmetic Improvement|"An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global Aesthetic Improvement Scale (GAIS; relative scale from Worse to Very much improved). If the post-treatment photograph was not correctly identified, that procedure will receive a “worse” on the rating scale."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.|||participants|||Number
1466697|NCT00729781|Primary|Functional Improvement|"Functional improvement was defined as a subject who achieves both 1) an improvement in the physical condition of the collapsed nasal valve as evidenced by an increase of >= 10% in the change in volume during inspiration as measured by Vectra 3D photography from baseline to 12 weeks post-procedure; and 2) a reduction of at least 30% in the symptoms of nasal obstruction as measured by the Nasal Obstruction Symptom Evaluation Scale (NOSE) scale (5 questions with 0-4 scale from Not a problem to Severe problem, possible score 0-100 via raw score × 5) from baseline to 12 weeks post-procedure."|12 weeks after implantation|An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.|||participants|||Number
1466698|NCT00729690|Secondary|Passive Knee Flexion|Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion).|PostOp day 2|All Completed Patients were used|||Degrees||Standard Deviation|Mean
1466699|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 12 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|12 hours Post dose|All Completed Patients|||Area (NRS*hr)||Standard Deviation|Mean
1466700|NCT00729690|Secondary|Active Knee Flexion|The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2|PostOp day 2|All completed patients used.|||Degrees||Standard Deviation|Mean
1466701|NCT00729690|Primary|NRS Pain Score AUC (NRS*hr) - 1st 24 Hours|Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain.|24 hours|All Completed Patients were included in the analysis.|||Area (NRS*hr)||Standard Deviation|Mean
1466702|NCT00729677|Post-Hoc|Number of Participants by Antiemetic Regimen Who Reported Nausea During First Cycle of Chemotherapy|Number of participants on 2-drug (5HT3 inhibitor plus steroid) versus 3 drug (2-drug regimen plus an NK-1 inhibitor) who reported nausea during the first cycle of chemotherapy. 5HT-3 inhibitors included ondansetron, dolasetron, granisetron, and palonosetron. The NK-1 inhibitor was aprepitant. The steroid was dexamethasone.|Week 1||||participants|||Number
1466703|NCT00729677|Primary|Number of Participants by History of Nausea Who Reported Nausea During the First Week of Chemotherapy|Number of participants with factors associated with increased frequency of nausea in the first cycle of chemotherapy, including history of motion sickness, history of pregnancy-related morning sickness, history of prior chemotherapy, and history of nausea associated with prior chemotherapy|week 1||||participants|||Number
1466704|NCT00729677|Primary|Impact of Nausea and Vomiting on the Patient's Quality of Life as Measured by the Functional Living Index – Emesis Scale at 5-7 Days|Scale describing impact of nausea and vomiting on quality of life on a seven-point Likert Scale with higher score indicating worse quality of life.|Week 1|this data was not collected||||||
1466705|NCT00729677|Primary|Percentages of Participants by Gender Who Reported Nausea During the First Week of Chemotherapy||Week 1 of FOLFOX chemotherapy||||percentage of participants|||Number
1466706|NCT00729651|Post-Hoc|Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||ng/ml||Standard Deviation|Mean
1466707|NCT00729651|Post-Hoc|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||participants|||Number
1466708|NCT00729651|Secondary|Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment||Baseline and 16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||Percentage Change Serum PTH||95% Confidence Interval|Least Squares Mean
1466709|NCT00729651|Primary|Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment||16 weeks|Participants for analysis was modified intention to treat (Number of patients : Fosamax Plus D Group was 136, Fosamax was 132). Missing data were imputed by the last observation carried forward (LOCF) technique.|||participants|||Number
1466710|NCT00729612|Secondary|Incidence and Intensity of Adverse Events Graded According to NCI CTCAE v. 3.0|The incidence and intensity of adverse events graded according to NCI CTCAE v. 3.0 will be evaluated using descriptive statistics|Up to 5 years|Grade 3 and 4|||patients|||Number
1466711|NCT00729612|Secondary|Overall Survival|Will be analyzed using a Kaplan-Meier methods.|Up to 5 years||||months||95% Confidence Interval|Median
1466712|NCT00729612|Secondary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 5 years||||months||95% Confidence Interval|Median
1466713|NCT00729612|Primary|Overall Response Rate Defined as Complete or Partial Response as Assessed by RECIST Version 1.0 Criteria.|Response rate is overall response rate (CR+PR) as defined by RECIST criteriaPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 5 years||||percentage of patients||95% Confidence Interval|Number
1466714|NCT00729586|Other Pre-specified|Number of Participants and Their Levels of Expression of the Candidate Markers|The levels of expression of the candidate markers measured prior to study treatment are tabulated. The expressions being tabulated include immunohistochemical expression of hormone receptors. The hormone receptors are estrogen receptor positive, progesterone receptors-A, progesterone receptor-B, PAKT Positive and PTEN Positive. The associations between the immunohistochemical expression of these biomarkers and between these biomarkers and treatment, outcome or clinical characteristics are reported for future investigation.|Baseline|Eligible and treated patients with primary tumor specimen|||participants|||Number
1466715|NCT00729586|Secondary|Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment.|Eligible and treated patients|||Participants|||Count of Participants
1472270|NCT00690378|Secondary|Microbiological Outcome in ME Patients at the LFU Visit|Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL|4 to 6 weeks post-therapy||||Participants|||Number
1466716|NCT00729586|Secondary|Duration of Progression-free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions.|Radiologic tumor evaluations at baseline and every six weeks for the first 24 weeks and then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.|Eligible and treated patients|||months||95% Confidence Interval|Median
1466717|NCT00729586|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every 6 weeks during treatment, then every 3 months for one year.|Eligible and treated patients|||months||95% Confidence Interval|Median
1466718|NCT00729586|Primary|Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0|RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Radiologic tumor evaluations at baseline and every 6 weeks for the first 24 weeks; then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.|Eligible and treated patients|||percentage of participants||94% Confidence Interval|Number
1466719|NCT00729560|Primary|DCI-IPG Measurements in Blood and Urine|zero participants analyzed, no assays performed|2 years|||||||
1466720|NCT00729521|Primary|Emergency Department and In-patient Hospitalization for Fall Injury|Rates of fall injury diagnoses per 100 person-years (P-Y) were computed for the communities in each of the study groups for a 2 year baseline period, 2007-2008, and for a 2 year follow-up period corresponding to years 2010-2011. Change in fall injury rates and their 95% confidence intervals (CI) are reported. A mixed-effects Poisson regression model was used to test the presence of an interaction effect on the fall rate between study group and time period (baseline or follow-up). The test is intended to detect a differential time effect by study group. This model, with main effects for study group and time period and an interaction term, will be referred to as the primary model. Model coefficients and incidence rate ratios (IRR) with 95% confidence intervals (CI) are reported.|2007-2008; 2010-2011|Population of residents aged 65 and older for participating communities in each study arm for 2007-2008 baseline period and 2010-2011 follow-up period.|||Fall Injury Rate per 100 person years||95% Confidence Interval|Number
1466721|NCT00729482|Secondary|Toxicity Profiles (According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0)||up to 24 weeks||||participants|||Number
1466722|NCT00729482|Secondary|Overall Survival||1 year||||Months||95% Confidence Interval|Median
1466723|NCT00729482|Secondary|Response Rate||2years|51 patients were available for response assessments.|||percentage of participants|||Number
1466724|NCT00729482|Primary|Progression-free Survival Rate at 4-month (16 Weeks)||4 months (16 weeks)||||percentage of participants|||Number
1466725|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
1466726|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dyspareunia Strata)||4 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
1466727|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal pain associated with sexual activity (dyspareunia strata) was assessed in 287 subjects in the placebo group and 295 subjects in the ospemifene 60 mg/day group.|||participants|||Number
1466728|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dyspareunia Strata)||4 weeks|ITT|||pH||Standard Deviation|Mean
1466729|NCT00729469|Secondary|Change From Baseline to Week 4 in Severity of Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||4 weeks|ITT; change from baseline to week 4 in severity of most bothersome symptom of vaginal dryness associated with sexual activity (dryness strata) was assessed in 152 subjects in the placebo group and 154 subjects in the ospemifene 60 mg/day group.|||participants|||Number
1466730|NCT00729469|Secondary|Change From Baseline to Week 4 in Vaginal pH (Dryness Strata)||4 weeks|ITT|||pH||Standard Deviation|Mean
1466731|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Pain Associated With Sexual Activity (Dyspareunia Strata)||12 weeks|ITT; LOCF|||participants|||Number
1466732|NCT00729469|Primary|Change From Baseline to Week 12 in Vaginal pH (Dyspareunia Strata)||12 weeks|ITT; LOCF|||pH||Standard Deviation|Mean
1466733|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smears (Dyspareunia Strata)||12 weeks|ITT; LOCF|||percentage of superficial cells||Standard Deviation|Mean
1466734|NCT00729469|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear (Dyspareunia Strata)||12 weeks|ITT; LOCF|||percentage of parabasal cells||Standard Deviation|Mean
1466735|NCT00729469|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness Associated With Sexual Activity (Dryness Strata)||12 weeks|ITT; LOCF|||participants|||Number
1466736|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Superficial Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT|||percentage of superficial cells||Standard Deviation|Mean
1466737|NCT00729469|Secondary|Change From Baseline to Week 4 in Percentage of Parabasal Cells in the Maturation Index (Dryness Strata)||4 weeks|ITT|||percentage of parabasal cells||Standard Deviation|Mean
1466741|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Infarct Size|Measured as change in infarct size from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
1466742|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction|Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
1466743|NCT00729430|Secondary|Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis|Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)|Measured in the 3-year follow-up period after participant's last study visit||||Percent Change||Standard Deviation|Mean
1466744|NCT00729430|Primary|Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling|Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)|Before and after study treatments||||Percent Change||Standard Deviation|Mean
1466745|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Tibia 66% Site|Baseline to 24-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1466746|NCT00729378|Primary|24-month Change in Cortical Thickness at the Tibia 66% Site|Baseline to 24-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466747|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 66% Site|Baseline to 24-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466748|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466749|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466750|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 66% Site|Baseline to 24-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466751|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Tibia 50% Site|Baseline to 24-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1466752|NCT00729378|Primary|24-month Change in Cortical Thickness at the Tibia 50% Site|Baseline to 24-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466998|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Size|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Error|Least Squares Mean
1466753|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 50% Site|Baseline to 24-month measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466754|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466755|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466756|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 50% Site|Baseline to 24-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466757|NCT00729378|Primary|24-month Change in Bone Strength Index at the Tibia 4% Site|Baseline to 24-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1466758|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Tibia 4% Site|Baseline to 24-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466759|NCT00729378|Primary|24-month Change in Cortical Bone Area at the Tibia 4% Site|Baseline to 24-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1466760|NCT00729378|Primary|24-month Change in Trabecular Bone Area at the Tibia 4% Site|Baseline to 24-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1466761|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466762|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466999|NCT00727857|Secondary|Change From Baseline in Mean Very Low Density Lipoprotein Particle Concentration|The change between Very Low Density Lipoprotein collected at final visit or week 24 and Very Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1466763|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Tibia 4% Site|Baseline to 24-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466764|NCT00729378|Primary|24-month Change in Stress-Strain Index at the Femur 20% Site|Baseline to 24-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1466765|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Femur 20% Site|Baseline to 24-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466766|NCT00729378|Primary|24-month Change in Thickness of Cortical Bone at the Femur 20% Site|Baseline to 24-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466767|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466768|NCT00729378|Primary|24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466769|NCT00729378|Primary|24-month Change in Total Volumetric Bone Density at the Femur 20% Site|Baseline to 24-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466770|NCT00729378|Primary|24-month Change in Bone Strength Index at the Femur 4% Site|Baseline to 24-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1466771|NCT00729378|Primary|24-month Change in Periosteal Circumference at the Femur 4% Site|Baseline to 24-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466772|NCT00729378|Primary|24-month Change in Cortical Bone Area at the Femur 4% Site|Baseline to 24-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1467000|NCT00727857|Secondary|Change From Baseline in Small High Density Lipoprotein (H1+H2) Concentration|The change between Small High Density Lipoprotein collected at final visit or week 24 and Small High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1466773|NCT00729378|Primary|24-month Change in Trabecular Bone Area at the Femur 4% Site|Baseline to 24-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1466774|NCT00729378|Primary|24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline to 24-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466775|NCT00729378|Primary|24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466776|NCT00729378|Primary|24-month in Change in Total Volumetric Bone Density the Femur 4% Site|Baseline to 24-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units mg/ccm.|Baseline to 24-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466777|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Tibia 66% Site|Baseline to 12-month change in strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1466778|NCT00729378|Primary|12-month Change in Cortical Thickness at the Tibia 66% Site|Baseline to 12-month change in cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466779|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 66% Site|Baseline to 12-month change in periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466780|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466781|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466782|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 66% Site|Baseline to 12-month change in total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1467005|NCT00727857|Secondary|Change From Baseline in Very Small Low Density Lipoprotein Concentration|The change between Very Small Low Density Lipoprotein collected at final visit or week 24 and Very Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1466783|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Tibia 50% Site|Baseline to 12-month change in strength-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1466784|NCT00729378|Primary|12-month Change in Cortical Thickness at the Tibia 50% Site|Baseline to 12-month change in cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466785|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 50% Site|Baseline to 12-month change in periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466786|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466787|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466788|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 50% Site|Baseline to 12-month change in total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466789|NCT00729378|Primary|12-month Change in Bone Strength Index at the Tibia 4% Site|Baseline to 12-month change in bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1466790|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Tibia 4% Site|Baseline to 12-month change in periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466791|NCT00729378|Primary|12-month Change in Cortical Bone Area at the Tibia 4% Site|Baseline to 12-month change in cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1466792|NCT00729378|Primary|12-month Change in Trabecular Bone Area at the Tibia 4% Site|Baseline to 12-month change in trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1467001|NCT00727857|Secondary|Change From Baseline in Intermediate-Medium High Density Lipoprotein (H3) Concentration|The change between Intermediate-Medium High Density Lipoprotein collected at final visit or week 24 and Intermediate-Medium High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1466793|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466794|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466795|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Tibia 4% Site|Baseline to 12-month change in total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466796|NCT00729378|Primary|12-month Change in Stress-Strain Index at the Femur 20% Site|Baseline to 12-month change in strength-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^3||Standard Deviation|Mean
1466797|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Femur 20% Site|Baseline to 12-month change in periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466798|NCT00729378|Primary|12-month Change in Thickness of Cortical Bone at the Femur 20% Site|Baseline to 12-month change in thickness of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466799|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466800|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466801|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density at the Femur 20% Site|Baseline to 12-month change in total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466802|NCT00729378|Primary|12-month Change in Bone Strength Index at the Femur 4% Site|Baseline to 12-month change in bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||mm^4||Standard Deviation|Mean
1467027|NCT00727714|Secondary|Changes in FeNO Measurements During One Shift (6-8h)||baseline and 6-8h|Problems With the FeNO (NIOX) device lead to few (58) included in FeNO measurements|||ppb||Full Range|Median
1466803|NCT00729378|Primary|12-month Change in Periosteal Circumference at the Femur 4% Site|Baseline to 12-month change in periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters (mm)||Standard Deviation|Mean
1466804|NCT00729378|Primary|12-month Change in Cortical Bone Area at the Femur 4% Site|Baseline to 12-month change in cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1466805|NCT00729378|Primary|12-month Change in Trabecular Bone Area at the Femur 4% Site|Baseline to 12-month change in trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||millimeters squared (mm^2)||Standard Deviation|Mean
1466806|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline to 12-month change in volumetric bone density of cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466807|NCT00729378|Primary|12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466808|NCT00729378|Primary|12-month Change in Total Volumetric Bone Density the Femur 4% Site|Baseline to 12-month change in total volumetric bone density at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline to 12-months|Population consists of all participants that had complete measurements at the baseline, 12-month and 24-month time points (N=207). At 12-months: Age=11.8 +/- 1.0 yrs; Height=153.3 +/- 9.9 cm; Weight=44.0 +/- 9.3 kg. At 24-months: Age=12.8 +/- 1.0 yrs; Height=158.8 +/- 9.1 cm; Weight=50.0 +/- 10.7 kg.|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466809|NCT00729378|Primary|Baseline Stress-Strain Index at the Tibia 66% Site|Baseline (initial) measurement of strength-strain index at the tibia 66% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
1466810|NCT00729378|Primary|Baseline Cortical Thickness at the Tibia 66% Site|Baseline (initial) measurement of cortical thickness at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466811|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 66% Site|Baseline (initial) measurement of periosteal circumference at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466812|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466813|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1467002|NCT00727857|Secondary|Change From Baseline in Large High Density Lipoprotein (H4+H5) Concentration|The change between Large High Density Lipoprotein collected at final visit or week 24 and Large High Density Lipoprotein collected at baseline|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1466814|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 66% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 66% site . Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466815|NCT00729378|Primary|Baseline Stress-Strain Index at the Tibia 50% Site|Baseline (initial) measurement of stress-strain index at the tibia 50% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
1466816|NCT00729378|Primary|Baseline Cortical Thickness at the Tibia 50% Site|Baseline (initial) measurement of cortical thickness at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466817|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 50% Site|Baseline (initial) measurement of periosteal circumference at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466818|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466819|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466820|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 50% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 50% site . Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466821|NCT00729378|Primary|Baseline Bone Strength Index at the Tibia 4% Site|Baseline (initial) measurement of bone strength index (BSI) at the tibia 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^4||Standard Deviation|Mean
1466822|NCT00729378|Primary|Baseline Periosteal Circumference at the Tibia 4% Site|Baseline (initial) measurement of periosteal circumference at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466823|NCT00729378|Primary|Baseline Cortical Bone Area at the Tibia 4% Site|Baseline (initial) measurement of cortical bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1466824|NCT00729378|Primary|Baseline Trabecular Bone Area at the Tibia 4% Site|Baseline (initial) measurement of trabecular bone area at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1466825|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site|Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1467003|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Size|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Error|Least Squares Mean
1466826|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Tibia 4% Site|Baseline (initial) measurement of total volumetric bone density at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466827|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 4% site . Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466828|NCT00729378|Primary|Baseline Stress-Strain Index at the Femur 20% Site|Baseline (initial) measurement of stress-strain index at the femur 20% site. Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones. Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: mm^3.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^3||Standard Deviation|Mean
1466829|NCT00729378|Primary|Baseline Cortical Thickness at the Femur 20% Site|Baseline (initial) measurement of cortical thickness at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466830|NCT00729378|Primary|Baseline Periosteal Circumference at the Femur 20% Site|Baseline (initial) measurement of periosteal circumference at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466831|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site|Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466832|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466833|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Femur 20% Site|Baseline (initial) measurement of total volumetric bone density at the femur 20% site . Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466834|NCT00729378|Primary|Baseline Bone Strength Index at the Femur 4% Site|Baseline (initial) measurement of bone strength index (BSI) at the femur 4% site. Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones. Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate. Measurement units: mm^4.|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||mm^4||Standard Deviation|Mean
1466835|NCT00729378|Primary|Baseline Periosteal Circumference at the Femur 4% Site|Baseline (initial) measurement of periosteal circumference at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: millimeters (mm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters (mm)||Standard Deviation|Mean
1466836|NCT00729378|Primary|Baseline Cortical Bone Area at the Femur 4% Site|Baseline (initial) measurement of cortical bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1466837|NCT00729378|Primary|Baseline Trabecular Bone Area at the Femur 4% Site|Baseline (initial) measurement of trabecular bone area at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: square millimeters (mm^2).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||millimeters squared (mm^2)||Standard Deviation|Mean
1467004|NCT00727857|Secondary|Change From Baseline in Mean High Density Lipoprotein Particle Concentration|The change between High Density Lipoprotein collected at final visit or week 24 and High Density Lipoprotein collected at baseline.|Baseline and Week 24||||μmol/L||Standard Error|Least Squares Mean
1466838|NCT00729378|Primary|Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site|Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466839|NCT00729378|Primary|Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site|Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 4% site . Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466840|NCT00729378|Primary|Baseline Total Volumetric Bone Density at the Femur 4% Site|Baseline (initial) measurement of total volumetric bone density at the femur 4% site. Measurement made by peripheral quantitative computed tomography (pQCT) at a distance of 4% of total femur length from the distal growth plate. Measurement units: milligrams per cubic centimeter (mg/ccm).|Baseline|Population consists of all participants that had complete measurements at the baseline time point (N = 503; Age = 10.6 +/- 1.1 yrs; Height = 144.5 +/- 9.7 cm; Weight = 39.2 +/- 10.5 kg).|||milligrams per cubic centimeter (mg/ccm)||Standard Deviation|Mean
1466841|NCT00729365|Secondary|We Will Assess Changes in the Relative Stiffness of Your Arteries (Endothelial Dysfunction) in Persons With Type 1 Diabetes Over the 5year Study.||year 1, 3, 5 and after the washout phase (5years and 1month)|||||||
1466842|NCT00729365|Primary|Development of Microalbuminuria (High Urine Albumin). Hypertension, Urine and Blood Markers Will Also be Evaluated for Assessment of Kidney Disease State.||at 3months and then every 6months during the 5years of the study|||||||
1466843|NCT00729326|Secondary|Episodes of Hypoglycemia (Overall)|Number of episodes of hypoglycemia experienced overall during the study|4 weeks and 8 weeks|All patients in FAS|||episodes of hypoglycemia|||Number
1466844|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Overall)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 weeks and 8 weeks|All patients in FAS|||Percentage of patients|||Number
1466845|NCT00729326|Secondary|Episodes of Hypoglycemia (Week 4 to Week 8)|Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study|8 weeks|All patients in FAS|||episodes of hypoglycemia|||Number
1466846|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|8 weeks|All patients in FAS|||Percentage of patients|||Number
1466847|NCT00729326|Secondary|Episodes of Hypoglycemia (Baseline to Week 4)|Number of episodes of hypoglycemia experienced during the first 4 weeks of the study|4 weeks|Full analysis set|||episodes of hypoglycemia|||Number
1466848|NCT00729326|Secondary|Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)|Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL|4 Weeks|All patients in FAS|||Percentage of patients|||Number
1466849|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal|Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1466850|NCT00729326|Secondary|Change in Postprandial Active GLP-1 AUC After the Morning Meal|Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1466851|NCT00729326|Secondary|Change in Postprandial Insulin AUC Excursion After the Morning Meal|Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1466852|NCT00729326|Secondary|Change in Postprandial Insulin AUC After the Morning Meal|Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1466853|NCT00729326|Secondary|Change in Postprandial C-peptide AUC Excursion After the Morning Meal|Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||nmol*hours/L||Standard Error|Least Squares Mean
1466854|NCT00729326|Secondary|Change in Postprandial C-peptide AUC After the Morning Meal|Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||nmol*hours/L||Standard Error|Least Squares Mean
1466855|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC Excursion After the Morning Meal|Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||mg*hours/dL||Standard Error|Least Squares Mean
1466856|NCT00729326|Secondary|Change in Postprandial Triglyceride AUC After the Morning Meal|Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||mg*hours/dL||Standard Error|Least Squares Mean
1466857|NCT00729326|Secondary|Change in Postprandial Glucagon AUC Excursion After the Morning Meal|Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1466858|NCT00729326|Secondary|Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal|Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)|baseline and 8 Weeks|All patients in the FAS who have both baseline and endpoint measurements; Last Observation Carried Forward|||pmol*hours/L||Standard Error|Least Squares Mean
1466859|NCT00729326|Secondary|Change in Fasting Blood Glucose After the Morning Meal|Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
1466860|NCT00729326|Secondary|Change in Two-hour Postprandial Glucose After the Morning Meal|Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)|baseline and 8 Weeks|All patients in FAS who have both baseline and endpoint measurement; Last Observation Carried Forward|||mg/dL||Standard Error|Least Squares Mean
1466861|NCT00729326|Primary|Change in Time-averaged Glucose During a 24 Hour Period|Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).|baseline and 8 Weeks|The number of patients was determined based on 90% powering of the study. Analyses were based on data from all randomized patients receiving at least one dose of the study drug and completing at least one treatment period. For each patient, the missing data for some time points were imputed by linear interpolation.|||mg/dL||Standard Error|Least Squares Mean
1466862|NCT00729248|Primary|CD4+CD25 High FOXP3+ Cell Levels in Mixed Lymphocyte Reactions (MLRs) of Renal Pre-transplant Recipients/Donors|CD4+CD25 high FOXP3+ cell levels in mixed lymphocyte reactions (MLRs) of Renal Pre-transplant Recipients/Donors were measured in the presence of 1) No Drug/Control; 2) 0.05-0.2, 0.3-3 and > 5 ng/ml Tacrolimus (TAC); OR 3) 0.05-0.2, 0.3-3 and > 5 ng/ml Sirolimus (SRL). CD4+CD25 high FOXP3+ cell levels in the MLRs with TAC or SRL are expressed as the percentage of CD4+CD25 high FOXP3+ cell levels in the MLRs with no drug.|3 months|For each arm, blood samples from 5 donor/recipient pairs (i.e., 10 participants) were used.|||Percentage of Control Cells||Standard Deviation|Mean
1466863|NCT00729183|Secondary|Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level|s-P1NP is a biochemical marker index of bone formation. s-P1NP was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. s-P1NP was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|PP population: All participants receiving at least one dose of study treatment and with available s-P1NP data, excluding participants with important deviations from the protocol that may have substantially affected the results.|||percent change||95% Confidence Interval|Least Squares Mean
1466864|NCT00729183|Secondary|Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level|s-CTx is a biochemical marker index of bone resorption. s-CTx was measured via fasting blood draws at Baseline (Randomization), Month 6, Month 12, Month 18, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures. S-CTx was analyzed using the log-transformed fraction from baseline using the per-protocol approach. Data were back-transformed for presentation and geometric LS mean percent change from baseline was reported with 95% CI.|Baseline, 12 months, 24 months|Per-Protocol (PP) population: All participants receiving at least one dose of study treatment and with available s-CTx data, excluding participants with important deviations from the protocol that may have substantially affected the results.|||percent change||95% Confidence Interval|Least Squares Mean
1466865|NCT00729183|Secondary|Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)|Trabecular vBMD at the lumbar spine (L2) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L2) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L2) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L2) baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466895|NCT00728988|Primary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 30 Days Post-percutaneous Coronary Intervention (PCI)|Percentage calculated as: (number of participants who experienced MACE [death, myocardial infarction, target vessel revascularization] within 30 days post-PCI) divided by (number of participants who experienced PCI) * 100. Major Adverse Cardiac Events (MACE) that occurred after 33 days post PCI were excluded.|30 days post PCI|Full Analysis Set (FAS): all participants who received at least one dose of study medication and received percutaneous coronary intervention (PCI). Last observation carried forward (LOCF).|||percentage of participants|||Number
1466866|NCT00729183|Secondary|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)|Trabecular vBMD at the lumbar spine (L1) was measured by quantitative computed tomography (QCT). All QCT-derived vBMD measurements were evaluated centrally (and possibly locally) for bone and soft tissue abnormalities. Trabecular vBMD at the lumbar spine (L1) was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization QCT spine (L1) endpoint data subsequent to at least one dose of study treatment, and having QCT spine (L1) baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466867|NCT00729183|Secondary|Percent Change From Baseline in Distal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the one-third distal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the distal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization distal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having distal radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466868|NCT00729183|Secondary|Percent Change From Baseline in Ultradistal Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the ultradistal radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the ultradistal radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization ultradistal radius aBMD endpoint data subsequent to at least one dose of study treatment, and having ultradistal radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466869|NCT00729183|Secondary|Percent Change From Baseline in Total Radius aBMD|aBMD (g/cm^2) data was measured by DXA at the total radius (forearm). aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total radius was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total radius aBMD endpoint data subsequent to at least one dose of study treatment, and having total radius aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466870|NCT00729183|Secondary|Percent Change From Baseline in Hip Trochanter aBMD|aBMD (g/cm^2) data was measured by DXA at the hip trochanter. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the hip trochanter was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization hip trochanter aBMD endpoint data subsequent to at least one dose of study treatment, and having hip trochanter aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466871|NCT00729183|Secondary|Percent Change From Baseline in Femoral Neck aBMD|aBMD (g/cm^2) data was measured by DXA at the femoral neck (hip). All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the femoral neck was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization femoral neck aBMD endpoint data subsequent to at least one dose of study treatment, and having femoral neck aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466872|NCT00729183|Secondary|Percent Change From Baseline in Total Hip aBMD|aBMD (g/cm^2) data was measured by DXA at the total hip. All measurements utilized the same hip and at least 2 vertebrae for all time points. The left hip only was scanned. If the left hip was unevaluable, then the right hip was scanned. Once the appropriate leg was identified for scanning, it was used for all subsequent measurements. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the total hip was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as secondary outcome measures.|Baseline, 12 months, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having post-randomization total hip aBMD endpoint data subsequent to at least one dose of study treatment, and having total hip aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466896|NCT00728962|Secondary|Crestal Bone Regression||four years|||||||
1466873|NCT00729183|Secondary|Percent Change From Baseline to Month 24 in Lumbar Spine aBMD|aBMD (g/cm^2) was measured by DXA at the lumbar spine and mean BMD measurements from at least 3 evaluable vertebrae from L1 through L4 were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal ANCOVA model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 24 months|FAS population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 24 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline data.|||percent change||95% Confidence Interval|Least Squares Mean
1466874|NCT00729183|Primary|Percentage of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that discontinued study treatment (different from discontinuation of the study) due to an AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|APaT population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.|||percentage of participants|||Number
1466875|NCT00729183|Primary|Percentage of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.|Up to ~14 days post study end (up to ~24 months)|All-Participants-as-Treated (APaT) population: all participants who took at least one dose of study medication, counted in the treatment group corresponding to the study treatment they actually received.|||percentage of participants|||Number
1466876|NCT00729183|Primary|Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)|aBMD (g/cm^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.|Baseline, 12 months|Full-Analysis-Set (FAS) population: a subset of All Randomized Participants with participants receiving at least one dose of study treatment, having Month 12 post-randomization lumbar spine aBMD endpoint data subsequent to at least one dose of study treatment, and having lumbar spine aBMD baseline (BL) data.|||percent change||95% Confidence Interval|Least Squares Mean
1466877|NCT00729157|Other Pre-specified|To Determine if Changes in Thyroglobulin Concentration After Four Cycles (Approximately 8 Weeks) of IV VEGF-Trap Therapy Correlate With Radiographic Response After Four Cycles (Approximately 8 Weeks)|This part is currently under data analysis, therefore, this outcome measure has not been calculated|8 weeks|||||||
1466878|NCT00729157|Other Pre-specified|To Determine if Pre-treatment Serum VEGF Concentration Correlates With Clinical Outcomes After IV VEGF Trap Therapy in Patients With Recurrent and/or Metastatic D-TC-FCO.|This part is currently under data analysis, therefore, this outcome measure has not been calculatedThis part is currently under data analysis, therefore, this outcome measure has not been calculated.|Baseline-6 months post treatment|||||||
1466879|NCT00729157|Secondary|Effect of Thyroglobulin Concentration on Progression-free Survival|The change is serum thyroglobulin was measured by the percent change between the baseline value and the lowest value obtained while on treatment.|6 months||||percent change serum thyroglobulin||Full Range|Median
1466880|NCT00729157|Secondary|To Determine the Biologic Effect of IV VEGF Trap on FDG Avidity After Four Cycles (Approximately 8 Weeks) of Therapy Through Pre- and Post-treatment FDG-PET Scans in Patients With Recurrent and/or Metastatic D-TC-FCO.|To determine the biologic effect of IV VEGF Trap on FDG avidity after four cycles (approximately 8 weeks) of therapy through pre- and post-treatment FDG-PET scans in patients with recurrent and/or metastatic D-TC-FCO.|8 weeks||||percent of SUVm change||95% Confidence Interval|Median
1466881|NCT00729157|Secondary|The Safety and Toxicity Profile of IV VEGF Trap in Patients With Recurrent and/or Metastatic TC-FCO|The number of participants, with recurrent and/or metastatic TC-FCO, who experienced adverse events. Please see the adverse event table for the specifics for this protocol.|From the beginning of treatment through 30 days until participant comes off study||||participants|||Number
1466897|NCT00728962|Primary|Patients With Implants Achieving Osseous Integration|Patients receiving test implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|1 year|total number of patients enrolled in the study was used for primary outcome analysis|||participants|||Number
1466898|NCT00728949|Primary|Overall Survival (OS)|OS is defined as the interval between date of randomization and the date of death due to any cause. Participants who are alive at the time of study completion will be censored at the time the participants was last known to be alive.|From randomization up to 36.5 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||months||90% Confidence Interval|Median
1466899|NCT00728949|Secondary|Changes in Circulating Tumor Cell Counts (CTS)||Approximately 24 months|Zero participants analyzed. Circulating tumor cell counts were not collected for analysis.||||||
1466882|NCT00729157|Primary|Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions & assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + P RMeasurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (CT, MRI, x-ray) or as ≥ 10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions (or sites of disease), including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm using spiral CT scan), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT or MRI), & cystic|After 8 weeks of study therapy||||participants|||Number
1466883|NCT00729157|Primary|Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate|Progression-free survival to determine the 6-month progression-free-survival (PFS) rate|6 months||||months||95% Confidence Interval|Median
1466884|NCT00729053|Secondary|Time to Disease Progression.|Time between the date of randomization to the Study Day of documented disease progression (an increase in tumor burden of at least 20%, appearance of new lesions, or unequivocal progression of non-measurable disease) or death (whichever comes first) by RECIST v1.0. Patients who had not progressed at last disease assessment, but whose progression status was unknown at the date last known alive, date of death, or date of study exit (whichever comes first), had event time censored at the date of last assessment. Patients who did not die and did not progress during treatment or follow-up had their event time censored on the last contact date.|Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression|ITT Population|||Days||95% Confidence Interval|Median
1466885|NCT00729053|Secondary|Overall Survival at 1 Year|Overall survival is defined as (date of death +1 - date of randomization). Patients without an event (death) during treatment or follow-up will have their date censored on the last visit the patient was known to be alive.|From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug.|ITT Population|||Participants|||Count of Participants
1466886|NCT00729053|Secondary|Duration of Response by RECIST v1.0|Time in days from the date of the first response by RECIST v1.0 to documented disease progression or death from any cause.|Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.|Participants with reported response as reflected in Outcome Measure 1|||Days|||Number
1466887|NCT00729053|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity|Number of patients with Treatment-emergent adverse events (TEAEs) by National Cancer Institute (NCI) grade/severity that began on or after the date of the first injection of study drug or worsened in severity or frequency after study drug was administered.|From start of treatment through one month after the end of study visit (up to 28 weeks)|Safety Population|||Participants|||Count of Participants
1466888|NCT00729053|Primary|Best Response by RECIST v1.0|Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.|From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.|ITT Population|||Participants|||Count of Participants
1466889|NCT00728988|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP)|C-reactive protein percent change from baseline = (post baseline value minus baseline value) divided by baseline value*100. Includes all CRP samples tested for the study, including samples unaffected and those samples affected by defective high-sensitivity (hs) CRP reagents.|Baseline, 8 hours, 24 hours and 30 days|FAS. N = number of subjects with non-missing values at baseline.|||percent change in CRP||Standard Error|Least Squares Mean
1466890|NCT00728988|Secondary|Percentage of Participants With Elevated Myoglobin|Myoglobin above the upper limit of normal from baseline (biomarker of myocardial injury): normal range: 0-109 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
1466891|NCT00728988|Secondary|Percentage of Participants With Elevated Troponin I|Troponin I above the upper limit of normal range from baseline (biomarker of myocardial injury): normal range: 0-0.5 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
1466892|NCT00728988|Secondary|Percentage of Participants With Elevated Creatine Kinase-MB (CK-MB)|CK-MB above the upper limit of normal range from baseline (biomarker of myocardial injury); normal range: 0-5.0 nanograms per milliliter (ng/mL).|8 hours, 24 hours and 30 days post PCI|FAS. N = number of participants with baseline and at least one post-baseline response.|||percentage of participants|||Number
1466893|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 24 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 24 hours post PCI) divided by (number of participants who experienced PCI) * 100.|24 hours post PCI|FAS.|||percentage of participants|||Number
1466894|NCT00728988|Secondary|Percentage of Participants With Major Adverse Cardiac Events (MACE) (Incidence of MACE) at 8 Hours Post-PCI|Percentage calculated as: (number of participants who experienced MACE within 8 hours post-PCI) divided by (number of participants who experienced PCI) * 100.|8 hours post PCI|FAS.|||percentage of participants|||Number
1466977|NCT00728182|Other Pre-specified|Number of New DWI Lesions (MRI) - Ruptured Aneuryms Subjects|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1466900|NCT00728949|Secondary|Number of Participants Experiencing Adverse Events (AEs) in National Cancer Institute Common Toxicity Criteria for AE's (NCI-CTCAE) Version 3.0 Criteria for Adverse Events (NCI-CTCAE)|The NCI-CTCAE provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Severity will be graded as mild (grade 1), moderate (grade 2), severe (grade 3), or very severe (life threatening – grade 4). Clinically significant events were defined as serious and other non-serious adverse events related to study drug regardless of causality. A summary of serious and other non-serious adverse events is located in the Reported Adverse Event module.|Randomization to End of Study up to 36.5 Months|Safety population: All participants who received actual treatment of any drug. There is a difference of 6 participants for treatment groups of IMC-A12 (Cixutumumab) + Antiestrogen and IMC-A12 (Cixutumumab) of ITT population and Safety population due to planned treatment (based on randomization) differed from actual treatment.|||Participants|||Count of Participants
1466901|NCT00728949|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) or Stable Disease (SD) Disease Control Rate [DCR])|DCR is defined as percentage of participants with CR, PR, or SD using RECIST v 1.0 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in SOD of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Randomization to PD up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment. Number of participants censored = 15 Cixutumumab + antiestrogen, 5 Cixutumumab only|||percentage of participants||95% Confidence Interval|Number
1466902|NCT00728949|Secondary|12-Month Survival Rate|The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.|From randomization to until the date of first documented date of death from any cause within 12 months, assessed up to 35.1 months|Intent-to-treat (ITT) population: All randomized participants who receive any drug.|||percentage of participants||90% Confidence Interval|Number
1466903|NCT00728949|Secondary|Percentage of Participants With Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])|Best overall response of CR or PR was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of longest diameter (SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Randomization to PD up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||percentage of participants||95% Confidence Interval|Number
1466904|NCT00728949|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from the date of randomization until date of objectively determined progressive disease (PD) or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a ≥20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions unequivocal progression of non-target lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS will be estimated following the Kaplan-Meier method.|From randomization up to 35.1 Months|Intent-to-treat (ITT) population: All randomized participants who were randomized regardless of actual treatment.|||months||90% Confidence Interval|Median
1466905|NCT00728923|Secondary|Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.|Patients given HAM-D (Hamilton Depression Scale), a measure of depressive symptoms. For the HAM-D the minimum units are 0 and Maximum units on the total scale are 50. The higher the number on the HAM-D, the more severe the symptoms. Response was defined as at least a 30% reduction on the HAM-D.|12 weeks||||participants|||Number
1466906|NCT00728923|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 30% reduction on the YBOCS.|12 weeks||||participants|||Number
1466907|NCT00728910|Primary|Post-prandial Triglyceride Incremental Area Under the Curve (iAUC)|Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)|4 weeks, 12 weeks, 22 weeks|subjects completing any phase of treatment for whom complete post-prandial data were available|||mg/dl*h||95% Confidence Interval|Mean
1466908|NCT00728910|Primary|Apo-A1 Production Rate|The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.|4 weeks, 12 weeks and 22 weeks|Patients who completed any phase of treatment for whom kinetic data were available|||mg/kg/day||95% Confidence Interval|Mean
1473878|NCT00678379|Secondary|Median Number of Pain Medication Doses|The median number of intravenous fentanyl doses administered in the PACU due to pain|in recovery room|per group doses|||number of doses||Full Range|Median
1466909|NCT00728910|Primary|The Apolipoprotein A-I Fractional Catabolic Rate (FCR)|After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.|4 weeks, 12 weeks and 22 weeks|Patients who completed any of the three phases for whom the kinetic study data was available for any phase of treatment|||pools/day||95% Confidence Interval|Mean
1466910|NCT00728884|Secondary|Crestal Bone Resorption||four years||2016-12-31|12/2016||||
1466911|NCT00728884|Primary|Osseous Integration||one year|total number of patients enrolled in the study were analyzed at this time (patients with implants not showing mobility).Patients receiving study implant(s) will achieve integration success (implant show no signs of mobility) of the implant at the time of analysis.|||participants|||Number
1466912|NCT00728845|Secondary|Overall Survival (Phase II)||Treatment start date to date of death|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1466913|NCT00728845|Secondary|Progression-free Survival at 1 Year (Phase II)||Treatment start date to 1 year|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1466914|NCT00728845|Secondary|Time to Progression (Phase II)||Treatment start date and date of progression|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1466915|NCT00728845|Primary|Overall Response (Phase II)||Treatment start date to date of best response|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1466916|NCT00728845|Primary|Recommended Phase II Dose of Hydroxychloroquine and Carboplatin When Administered With Paclitaxel and Bevacizumab (Phase I)||Followed for the duration of the phase 1 treatment, an average of 18 weeks|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
1466917|NCT00728819|Secondary|Symptomatic PICC-related Venous Thrombosis|Symptomatic PICC-related venous thrombosis|Procedure through 28 days|Number of participants who had this outcome measure|||Participants|||Count of Participants
1466918|NCT00728819|Secondary|Post-operative Bleeding|Post-operative bleeding|Day 1|Number of participants who received the intervention as assigned|||Participants|||Count of Participants
1466919|NCT00728819|Primary|Evidence of PICC-related Venous Thrombosis|Number participants with vein thrombosis|28 days, PICC removal or hospital discharge||||Participants|||Count of Participants
1466920|NCT00728754|Secondary|Osseous Integration||four years|||||||
1466921|NCT00728754|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population analyzed was all patients receiving implants enrolled in the study, those reported here actually represent the number of implants being followed at the 12 month follow-up time point (time of analysis).|||millimeters|implants|Standard Error|Mean
1466922|NCT00728728|Secondary|Clinical Global Impressions (CGI) Scale|The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)|Missing data for a total of 5 participants for the CGI.|||score||Standard Error|Mean
1466923|NCT00728728|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
1466924|NCT00728728|Secondary|The Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.|Prospective, outcome measures collected over 10 week trial period.||||total score||Standard Error|Mean
1466925|NCT00728728|Primary|Scale for the Assessment of Negative Symptoms(SANS)|The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
1466926|NCT00728728|Primary|Brief Assessment of Cognition in Schizophrenia (BACS)|The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory & Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||Z score||Standard Error|Mean
1466927|NCT00728728|Primary|University of California Performance-based Skills Assessment (UPSA)|The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||total score||Standard Error|Mean
1466928|NCT00728728|Primary|MATRICS Consensus Cognitive Battery (MCCB)|"The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.~The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance."|Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)||||T score||Standard Error|Mean
1466929|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Tmax|Time to maximum plasma concentration(Tmax; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||hours||Standard Deviation|Mean
1466930|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: Cmax|Maximum drug concentration in plasma, determined directly from individual concentration-time data (Cmax)|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants as 'per protocol'. Form V group lost a particpant during wash-out period due to death in the family.|||ng/mL||Standard Deviation|Mean
1466931|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-∞|Area under the drug concentration-time curve from time zero to infinity (AUC0-∞; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.|||ng*hr/mL||Standard Deviation|Mean
1466932|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: AUC0-τ|Area under the drug concentration-time curve from time zero to time t, where t is the last timepoint with a drug concentration ≥ lowest obtainable quantification (AUC0-τ; ng*hr/mL).|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||ng*hr/mL||Standard Deviation|Mean
1466933|NCT00728689|Primary|Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½|Mean terminal half-life (t½; hrs) for Forms I and V were calculated from [plasma] vs time profiles.|Post-dose samples at 0.5,1,2,3,4,8,12,24,36,48,72 hrs|Both groups started with 12 particpants. Outlier values were excluded from the half-life analyses for 3 subject PK profiles (one Form I and 2 Form V). Form V group lost a particpant during wash-out period due to death in the family.|||hours||Standard Deviation|Mean
1466934|NCT00728689|Secondary|Number of Study Participants Who Tolerated a Single Dose of ST-246 Form I vs. Form V as Determined by No Clinically Significant Changes in Safety Parameters|"Evaluated safety parameters included:~physical examination/vital signs~electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)~laboratory safety tests (hematology, chemistry, urinalysis)~adverse events For a), b) and c), summary statistics (mean,SD, median, minm, maxm)for values, and changes from baseline(Day 1 pre-dose) to each timepoint, were measured and compared to laboratory normal reference ranges. Values for a)- d) were assigned grades according to DAIDS AE Grading Table. Any Grade of 3 or higher was considered severe and significant."|4 weeks|Both groups started with 12 particpants. Form V group lost a particpant during wash-out period due to death in the family.|||participants|||Number
1466935|NCT00728507|Primary|To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens.|Study was prematurely terminated and data was not collected for this outcome measure.|Weekly or more frequent|||||||
1466936|NCT00728507|Primary|To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy.|LJ culture conversion|Week 8|modified intention to treat population|||percentage of participants|||Number
1466937|NCT00728494|Primary|The Number of Participants Who Relapsed at 6 Months Post-treatment|Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment|Measured at end of treatment and 6 months post-treatment||||Participants|||Number
1466938|NCT00728494|Primary|The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment|Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment|Measured at 6 months post-treatment||||Participants|||Number
1466939|NCT00728494|Secondary|Average Dosage of Rebetol|Rebetol dosage was expressed in milligrams per kilogram of body weight per day.|Up to 48-week treatment duration||||mg/kg/day||Standard Deviation|Mean
1466940|NCT00728494|Secondary|Average Dosage of PegIntron|Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week|Up to 48-week treatment duration||||micrograms/kg/week||Standard Deviation|Mean
1466941|NCT00728494|Secondary|Average Length of Treatment|Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.|Maximum 48-week treatment duration||||Participants|||Number
1466942|NCT00728494|Primary|The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C|Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program|At the end of the 48-week treatment period||||Participants|||Number
1466943|NCT00728481|Primary|Symptomatic Response to Treatment|"Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30).~Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study."|Baseline, 6 months||||Participants|||Number
1466944|NCT00728481|Secondary|Participants With Presence of Erosive Esophagitis at Six Month Endoscopy||Baseline, 6 months||||participants|||Number
1466945|NCT00728481|Secondary|Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy|Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.|Baseline, 6 months||||participants|||Number
1466946|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.|Baseline, 6 months|The analysis population for this item only included subjects with a non-significant histologic response. Subjects were considered to have a histological response to treatment if both sets of 6-month biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.|||Participants|||Number
1466947|NCT00728481|Secondary|Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment|Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.|Baseline, 6 months|The analysis population includes only subjects with a histologic response. Subjects were considered to have a histological response to treatment if both sets of biopsies (from distal & mid-esophagus) had, on average, less than 5 eos/hpf.|||Participants|||Number
1466948|NCT00728481|Primary|Histological Response to Treatment|Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.|Baseline, 6 months||||Participants|||Number
1466949|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.||||||
1466950|NCT00728468|Other Pre-specified|Ratio of Dextromethorphan Area Under the Curve to Dextrorphan Area Under the Curve 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Ratio of AUC was a derived parameter. As the primary endpoint for the study was not met, only the primary parameter AUC was analyzed and reported. Other parameters were not derived for this study based on investigator’s decision.||||||
1466951|NCT00728468|Secondary|Time to Tumor Progression (TTP)|Time in months from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.437. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD).|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|All enrolled participants|||months||95% Confidence Interval|Median
1466952|NCT00728468|Secondary|Duration of Response (DR)|Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Participants with a response (CR or PR) in response analysis set.|||weeks||95% Confidence Interval|Median
1466953|NCT00728468|Secondary|Best Overall Response (BOR)|BOR: investigator assessment by Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD): >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.|Baseline, end of every even-numbered cycle until disease progression up to end of treatment (up to 18 months)|Response anslysis set: all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment.|||participants|||Number
1466954|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan on Cycle 2 Day 7|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day 7 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day 7.|8 hours after dosing on Day 7|PK parameter analysis population|||ratio||Standard Deviation|Mean
1466978|NCT00728182|Other Pre-specified|Volume of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose (pre-specified subgroup analysis)|Enrolment, Days 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1466955|NCT00728468|Primary|Urinary Metabolic Ratio (UMR) of Dextromethorphan to Dextrorphan 3 Days Prior to PF-00299804 Dosing|The UMR was calculated as the ratio of the amount of dextrmotherphan excreted in urine from time zero to 8 hours post-dose on Day -3 to the amount of dextrorphan excreted in urine from time zero to 8 hours post-dose on Day -3.|8 hours after dosing on Day -3|PK parameter analysis population: all participants enrolled who were extensive metabolizers (EM), & treated who had at least 1 PK parameter of primary interest in at least 1 treatment period. EMs were defined as participants with a baseline UMR ≤0.3 & were either ultrarapid, extensive, or intermediate metabolizers as predicted by CYP2D6 genotyping.|||ratio||Standard Deviation|Mean
1466956|NCT00728468|Primary|Oral Clearance For Dextromethorphan on Cycle 2 Day 7|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.||||||
1466957|NCT00728468|Primary|Oral Clearance For Dextromethorphan 3 Days Prior to PF-00299804 Dosing|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Results not reported as data did not support calculation since levels of dextromethorphan were not tracked long enough for reliable estimation.||||||
1466958|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan on Cycle 2 Day 7|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Standard Deviation|Mean
1466959|NCT00728468|Primary|Plasma Decay Half-Life (t1/2) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Standard Deviation|Mean
1466960|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Full Range|Median
1466961|NCT00728468|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||hours||Full Range|Median
1466962|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng/mL||Standard Deviation|Mean
1466963|NCT00728468|Primary|Maximum Observed Plasma Concentration (Cmax) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng/mL||Standard Deviation|Mean
1466964|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan on Cycle 2 Day 7|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
1466997|NCT00727857|Secondary|Change From Baseline in Large-Chylomicrons Very Low Density Lipoprotein Concentration|The change between Large-Chylomicrons Very Low Density Lipoprotein collected at final visit or week 24 and Large-Chylomicrons Very Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1467028|NCT00727714|Primary|Changes in Lung Function Measurements During One Work Shift (6-8h)|Changes in lung function measurements during one work shift (6-8h), spirometry and gass diffusion capacity|baseline and 6-8h||||Litres||Standard Deviation|Mean
1466965|NCT00728468|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) For Dextrorphan 3 Days Prior to PF-00299804 Dosing|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
1466966|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan on Cycle 2 Day 7|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Cycle 2 Day 7: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|PK analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||ng*hr/mL||Standard Deviation|Mean
1466967|NCT00728468|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For Dextromethorphan and Dextrorphan 3 Days Prior to PF-00299804 Dosing|Area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (AUClast). Dextrorphan is an active metabolite of dextromethorphan.|Day -3: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose|Pharmacokinetic (PK) analysis population included all participants that were extensive metabolizers and treated, had at least 1 of PK parameters of primary interest in at least 1 treatment period. Here, N (number of participants analyzed) signifies who received PF-00299804 daily without interruptions or dose reductions prior to Day 7 of Cycle 2.|||nanograms*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
1466968|NCT00728416|Secondary|Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days|Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1466969|NCT00728416|Primary|Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days|Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.|15 days of treatment|1 participant without baseline value excluded from the Placebo Nasal Spray population.|||Units on a scale||95% Confidence Interval|Least Squares Mean
1466970|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 31 up to Day 180 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1466971|NCT00728260|Other Pre-specified|Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination From Inpatient Database – All Ages Combined|Only persons who received Menactra vaccine during the study period were surveyed and included in this outcome.|Day 0 up to 6 months post-vaccination|Only persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 doses|||Number
1466972|NCT00728260|Primary|Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level.|Incidence rates for each diagnosis were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison window. Clinical setting is given in parenthesis as (H) for hospital.|Day 0 up to Day 30 post-vaccination|All persons who received Menactra vaccine during the study period were included in the analysis.|||Events per 1,000 person-months|||Number
1466973|NCT00728182|Other Pre-specified|Modified Rankin Scale (mRS)- Ruptured Aneurysm Subjects|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 with ruptured aneurysms was compared in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30||||No. of participants with mRS 0-2|||Number
1466974|NCT00728182|Other Pre-specified|National Institutes of Health Stroke Scale (NIHSS) - Ruptured Aneurysm Subjects|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for participants with ruptured aneurysms in both treatment groups(pre-specified subgroup analysis).|Enrolment, Day 30|All subjects who entered the study with a ruptured aneurysm, who received study drug and outcome assessment at Day 30.|||No. of participants with NIHSS 0-1|||Number
1466975|NCT00728182|Other Pre-specified|Volume of New DWI Lesions (MRI) - Ruptured Aneurysm Subjects|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1466976|NCT00728182|Other Pre-specified|Number of New FLAIR Lesions (MRI) - Ruptured Aneurysm Subjects|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose(pre-specified subgroup analysis)|Enrolment, Day 2-4|All subjects who entered the study with a ruptured aneurysm, who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1466979|NCT00728182|Secondary|Modified Rankin Scale (mRS).|The mRS is a measure of global disability that has been widely applied for evaluating recovery from stroke. Scores range from 0 to 6, with higher scores indicating greater disability. A score of 0 indicates no residual symptoms; 1 = no significant disability/able to carry out all usual activities, despite some symptoms; 2 = slight disability; 3 = moderate disability; 4 = moderately severe disability; 5 = severe disability; 6 = death. The number of participants scoring 0-2 on the mRS at Day 30 was compared in both treatment groups.|Enrolment, Day 30|All patients who received study drug and an outcome assessment at Day 30|||No. of participants with mRS 0-2|||Number
1466980|NCT00728182|Secondary|National Institutes of Health Stroke Scale (NIHSS).|The NIHSS is a standardized neurological method to measure disability and recovery after stroke. Scores range from 0 to 42, with higher scores indicating increasing severity. Scores were dichotomized into 0-1 (good outcome) versus 2 or above. The number of participants scoring 0-1 on the NIHSS at Day 30 was compared for both groups.|Enrolment, Day 30|All patients who received study drug and outcome assessment at Day 30.|||No. of participants with NIHSS 0-1|||Number
1466981|NCT00728182|Secondary|Volume of New DWI Lesions (MRI)|Volume of new DWI lesions as defined by MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1466982|NCT00728182|Secondary|Number of New FLAIR Lesions (MRI)|Number of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose.|Enrolment, Days 2-4|All patients who received study drug and an analyzable MRI scan at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1466983|NCT00728182|Secondary|Number of New DWI Lesions (MRI)|Number of new ischemic lesions as defined by DWI MRI at 12-95 hours postdose.|Enrolment, Day 2-4|All patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||Lesions||Standard Deviation|Mean
1466984|NCT00728182|Primary|Volume of New FLAIR Lesions(MRI)|Volume of new ischemic lesions as defined by FLAIR MRI at 12-95 hours postdose|Enrolment, Days 2-4|All study patients who received study drug and an analyzable MRI at 12-95 hours postdose.|||mm^3||Standard Deviation|Mean
1466985|NCT00728130|Secondary|The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.|Pathological detection of carcinoma within each of the dissected nodes reported as node groups.|Post surgical time point||||carcinoma positive nodes||Standard Deviation|Mean
1466986|NCT00728130|Primary|the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland.|The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.|Post Surgical Time point||||nodes||Standard Deviation|Mean
1466987|NCT00727961|Primary|Number of Participants With Progression|Progressive disease was defined as 25% or greater increase in the size of measurable lesion. The reappearance of any lesion or clear worsening of assessable disease or the appearance of any new lesion was also considered as progressive disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
1466988|NCT00727961|Primary|Number of Participants With Stabilization|All other subjects (except complete or partial responders and those with progression [see prior definitions]) were classified as stable disease as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
1466989|NCT00727961|Primary|Number of Participants With Partial Response|Required 50 percent or greater decrease in sum of products of all bidimensionally measurable lesions without progression of assessable disease and no new lesions as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||Participants|||Number
1466990|NCT00727961|Secondary|Mean Survival Time During the Study|Mean time to the occurrence of death|from the beginning of study drug administration up to 18 months||||days||95% Confidence Interval|Mean
1466991|NCT00727961|Secondary|Median Time to Progression|Median time to the occurence of progression. Progression was defined as 25 percent or greater increase size of measurable lesion. Reappearance of lesion, worsening of assessable disease or appearance new lesions were considered progression as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|from the beginning of study drug administration up to 4 weeks after chemotherapy completed||||days||95% Confidence Interval|Median
1466992|NCT00727961|Secondary|Mean Time to Positive (Partial) Treatment Response Achievement|"Time to the occurence of partial effect achievement as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.~Partial response required a 50 percent or greater decrease in the sum of the products of all bidimensionally measurable lesions without progression of any assessable disease and no new lesions."|from the beginning of study drug administration up to 4 weeks after chemotherapy completed||||days||Standard Deviation|Mean
1466993|NCT00727961|Primary|Number of Participants With Complete Response|Complete response was defined as complete disappearance of all measurable and assessable disease with no new disease or disease-related symptoms as measured by chest x-ray, computed tomography scan, and magnetic resonance imaging.|4 weeks after chemotherapy completed||||participants|||Number
1466994|NCT00727909|Primary|Percentage of Participants That Selected a Particular Type of Hearing Aid||At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)||||percentage of participants|||Number
1466995|NCT00727857|Secondary|Change From Baseline in Small Very Low Density Lipoprotein (V1+V2) Concentration|The change between Small Very Low Density Lipoprotein collected at final visit or week 24 and Small Very Low Density Lipoprotein collected at baseline|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||nmol/L||Standard Error|Least Squares Mean
1466996|NCT00727857|Secondary|Change From Baseline in Medium-Intermediate Very Low Density Lipoprotein (V3+V4) Concentration|The change between Medium-Intermediate Very Low Density Lipoprotein collected at final visit or week 24 and Medium-Intermediate Very Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1467511|NCT00724815|Secondary|Nausea Free at Two Hours|Number of subjects who were nausea free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1467006|NCT00727857|Secondary|Change From Baseline in Small Low Density Lipoprotein Concentration|The change between Small Low Density Lipoprotein collected at final visit or week 24 and Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1467007|NCT00727857|Secondary|Change From Baseline in Medium-Small Low Density Lipoprotein Concentration|The change between Medium-Small Low Density Lipoprotein collected at final visit or week 24 and Medium-Small Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1467008|NCT00727857|Secondary|Change From Baseline in Intermediate-Density Low Density Lipoprotein Concentration|The change between Intermediate-Density Low Density Lipoprotein collected at final visit or week 24 and Intermediate-Density Low Density Lipoprotein collected at baseline|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1467009|NCT00727857|Secondary|Change From Baseline in Large Low Density Lipoprotein (L3) Concentration|The change between Large Low Density Lipoprotein collected at final visit or week 24 and Large Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nmol/L||Standard Error|Least Squares Mean
1467010|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Size|The change between Low Density Lipoprotein collected at final visit or week 24 and Low Density Lipoprotein collected at baseline.|Baseline and Week 24||||nm||Standard Deviation|Least Squares Mean
1467011|NCT00727857|Secondary|Change From Baseline in Mean Low Density Lipoprotein Particle Concentration|The change between Low Density Lipoprotein particle concentration collected at final visit or week 24 and Low Density Lipoprotein particle concentration collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||nmol/L||Standard Error|Least Squares Mean
1467012|NCT00727857|Secondary|Change From Baseline in Triglycerides|The change between Triglycerides collected at final visit or week 24 and Triglycerides collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1467013|NCT00727857|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol|The change between High-Density Lipoprotein Cholesterol collected at final visit or week 24 and High-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1467014|NCT00727857|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol|The change between Low-Density Lipoprotein Cholesterol collected at final visit or week 24 and Low-Density Lipoprotein Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1467015|NCT00727857|Secondary|Change From Baseline in Total Cholesterol|The change between Total Cholesterol collected at final visit or week 24 and Total Cholesterol collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1467016|NCT00727857|Secondary|Change From Baseline in Adiponectin|The change between Adiponectin collected at final visit or week 24 and Adiponectin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mcg/ml||Standard Error|Least Squares Mean
1467017|NCT00727857|Secondary|Median Percent Change From Baseline in High Sensitivity C-reactive Protein|Measurement for High Sensitivity C-reactive Protein was collected at final visit or week 24 and at baseline. Percent change from baseline is calculated as: [(Week 24 - baseline levels)/baseline]*100|Baseline and Week 24||||percent||Full Range|Median
1467018|NCT00727857|Secondary|Change From Baseline in Homeostasis Model Assessment - Insulin Resistance|The change between Homeostasis Model Assessment of Insulin Resistance collected at final visit or week 24 and Homeostasis Model Assessment of Insulin Resistance collected at baseline. Homeostasis Model Assessment measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5).|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||percent of insulin resistance||Standard Error|Least Squares Mean
1467019|NCT00727857|Secondary|Change From Baseline in Fasting Insulin|The change between the Fasting Insulin value collected at final visit or week 24 and Fasting Insulin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||μIU/mL||Standard Error|Least Squares Mean
1467020|NCT00727857|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the value of Fasting Plasma Glucose collected at final visit or week 24 and Fasting Plasma Glucose collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. LOCF for missing final/week 24 visit|||mg/dL||Standard Error|Least Squares Mean
1467021|NCT00727857|Primary|Percent Change From Baseline in Glycosylated Hemoglobin|The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final visit or week 24 and Glycosylated Hemoglobin collected at baseline.|Baseline and Week 24|Participant must have baseline and at least one post-baseline value. Last Observation Carried Forward (LOCF) for missing final/week 24 visit|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1467022|NCT00727844|Primary|Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months.||Sputum smear conversion or max 4 months after the start of Linezolid therapy.||||participants|||Number
1467023|NCT00727740|Primary|Reduction in Pancreatitis Rate|Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.|24 hours||||percentage of participants with PEP|||Number
1467024|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers Between Baseline and 32 h||0-32h||||ng/Litre||Full Range|Median
1467025|NCT00727714|Secondary|Changes in FeNO Measurements Between Baseline (0h) and 32 h||0-32h||||ppb||Full Range|Median
1467026|NCT00727714|Secondary|Changes in Serum/Plasma Inflammatory Markers During One Shift (6-8h)||Baseline and 6-8h||||ng/Litre||Full Range|Median
1467029|NCT00727649|Secondary|Fecal Incontinence Severity Index Score, FISI|The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms.|baseline, 4 week and 12 weeks||||units on a scale||Standard Deviation|Mean
1467030|NCT00727649|Primary|Percentage of Bowel Movements With Incontinence|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups.|4 weeks||||percentage of incontinent bowel movement||Standard Deviation|Mean
1467031|NCT00727649|Primary|7-day Bowel Diary, Number of Fecal Incontinence Episodes|After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups.|6 weeks and 12 weeks||||Fecal incontinence episodes||Standard Deviation|Mean
1467032|NCT00727636|Primary|Antibody Titer to HPV 18|Geometric mean titer (95%CI)|Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1467033|NCT00727636|Primary|Antibody Titers to HPV 16|Geometric mean titer (95% CI)|Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1467034|NCT00727636|Primary|Antibody Titer to HPV 11||Month 7|Number of participants who completed all vaccine doses|||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1467035|NCT00727636|Primary|Antibody Titer to HPV 6||Month 7||||milli-Merck units/mL||95% Confidence Interval|Geometric Mean
1467036|NCT00727597|Primary|Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events||96 weeks||||participants|||Number
1467037|NCT00727597|Primary|Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)|"Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons:~To resolve a Grade 3 or 4 Adverse Event~The subject experienced a virologic failure (as defined in section 3.6.2)~The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue~The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)"|96 weeks||||participants|||Number
1467038|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Right Leg|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pounds||Standard Deviation|Mean
1467039|NCT00727571|Secondary|Physical Performance: Lower Extremity Strength, Left Leg.|Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pounds||Standard Deviation|Mean
1467040|NCT00727571|Secondary|Physical Performance: Grip Strength|Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||pound-force||Standard Deviation|Mean
1467041|NCT00727571|Secondary|Physical Performance: Time to Rise From Sitting to Standing|Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||seconds||Inter-Quartile Range|Median
1467042|NCT00727571|Secondary|Physical Performance: Duration Walked or Wheeled at Each Visit|The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.|Weeks 2, 14, 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||minutes||Standard Deviation|Mean
1467043|NCT00727571|Secondary|Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||feet per minute||Standard Deviation|Mean
1467044|NCT00727571|Secondary|Estimated Glomerular Filtration Rate (GFR) for Participants With CKD|Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x [Serum creatinine]^-1.154 x [Age]^-0.203 x [0.742 if patient is female] x [1.210 if patient is black]. 2. Cockcroft-Gault formula: GFR = (140-age) * (Weight in kg) * (0.85 if female) / (72 * Serum Creatinine).|Weeks 1, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||mL/min/1.73 m^2||Standard Deviation|Mean
1467062|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase I|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
1467045|NCT00727571|Secondary|Percentage of Participants With Anemia Related Conditions at Baseline|"The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative.~Vitamin B12 and folate deficiency based on standard laboratory ranges."|Baseline|Enrolled patients with anemia|||Percentage of participants|||Number
1467046|NCT00727571|Secondary|Number of Participants With Anemia|Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin <12 g/dL in women, < 13 g/dL in men.|Baseline|All enrolled patients with available anemia lab results.|||participants|||Number
1467047|NCT00727571|Primary|Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit|The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).|Weeks 2, 14 and 26|"Enrolled patients with CKD and non-missing data at each time point (indicated by N)."|||feet||Inter-Quartile Range|Median
1467048|NCT00727558|Secondary|Inferior Region Corneal Staining|National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=243).|||Units on a scale||Standard Error|Least Squares Mean
1467049|NCT00727558|Secondary|Initial Comfort|"Rating of comfort immediately when you first put them on using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent."|at 1 week|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
1467050|NCT00727558|Secondary|End of Day Comfort|Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
1467051|NCT00727558|Secondary|How Comfortable Eyes Feel at the End of the Day|"Rating of How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable."|at 1 week wear|Analysis includes participants who completed the study per protocol and had no missing data.|||Units on a scale||Standard Error|Least Squares Mean
1467052|NCT00727558|Secondary|Overall Handling|Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.|at 1 week of wear|Analysis includes participants who completed the study per protocol and had no missing data (n=240).|||Units on a scale||Standard Error|Least Squares Mean
1467053|NCT00727558|Primary|Measured Limbal Hyperemia|Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.|at 1 week of wear.|Analysis includes participants who completed the study per protocol and had no missing data (n=243).|||Units on a scale||Standard Error|Least Squares Mean
1467054|NCT00727558|Primary|Overall Comfort|Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent|at 1 week of wear.|Analysis includes participants who completed the protocol and had no missing data (n=240)|||Units on a scale||Standard Error|Least Squares Mean
1467055|NCT00727506|Secondary|Number of Participants With Clinically Relevant Abnormalities for Decreased Cardiac Left Ventricular Function - Phase II|Number of participants with Clinically Relevant Abnormalities for decreased Cardiac left ventricular function.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1467056|NCT00727506|Secondary|Causes of Death - Phase II|Causes of death during on treatment.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||deaths|||Number
1467057|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase II|Safety of Afatinib assessed based on the number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1467058|NCT00727506|Secondary|Number of Participants With Adverse Events (AEs) Based on Intensity and Incidence of AE's - Phase II|Safety of afatinib as indicated by number of participants with adverse events based on intensity and incidence of AE's, especially skin reactions (rash, acne), gastrointestinal (GI) (Vomiting, nausea, diarrhea) and neurological.|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1467059|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AE Leading to Dose Reduction, AEs Leading to Discontinuation of Trial Drug and All SAE- Phase II|Safety was assessed based on number of participants with investigator defined drug−related AEs, AE leading to dose reduction, Adverse events (AEs) leading to discontinuation of trial drug and All Serious Adverse events (SAE).|From first administration of treatment until 28 days after last drug administration, up to 518 days.|Treated set|||Participants|||Number
1467060|NCT00727506|Secondary|Causes of Death - Phase I|Cause of the death reported during on treatment was due to disease progression.|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||deaths|||Number
1467061|NCT00727506|Secondary|Number of Participants With Adverse Events, Graded According CTCAE - Phase I|Safety of Afatinib assesed based on Number of participants with adverse events, graded according to United States National Cancer Institute Common terminology Criteria for Adverse Events (US NCI CTCAE) Version 3.0. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
1467063|NCT00727506|Secondary|Number of Participants With Investigator Defined Drug−Related AEs, AEs Leading to Discontinuation of Trial Drug, All Serious Adverse Events (AE) and Other Significant AEs - Phase I|Safety was assessed based on number of participants with investigator defined drug−related AEs, AEs leading to discontinuation of trial drug, All Serious Adverse events (AE) and other significant AEs (according to International Conference on Harmonisation (ICH) E3).|From first administration of treatment until 28 days after last drug administration, up to 491 days.|Treated set|||Participants|||Number
1467064|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP10) Assessed by FISH|Number of participants with Chromosomes (CEP10) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP10) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1467065|NCT00727506|Secondary|Number of Participants With Chromosomes (CEP7) Assessed by FISH|Number of participants with Chromosomes (CEP7) assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Chromosomes (CEP7) by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1467066|NCT00727506|Secondary|Number of Participants With PTEN Assessed by FISH|Number of participants with PTEN assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for PTEN by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1467067|NCT00727506|Secondary|Number of Participants With EGFR Assessed by FISH|Number of participants with EGFR assessed by FISH for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFR by fluorescent in situ hybridization (FISH).|Baseline (during screening)|Randomized set|||Participants|||Number
1467068|NCT00727506|Secondary|Number of Participants With PAKT Marker Assessed by IHC Test.|Number of participants with PAKT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Serinethreonine kinase (PAKT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1467069|NCT00727506|Secondary|Number of Participants With PTEN Marker Assessed by IHC Test.|Number of participants with PTEN marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Phosphatase and Tensin Homologue – a tumor suppressor gene/protein (PTEN) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1467070|NCT00727506|Secondary|Number of Participants With EGFR Marker Assessed by IHC Test.|Number of participants with EGFR marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for Epidermal Growth Factor Receptor (EGFR) by immunohistochemistry (IHC) test|Baseline (during screening)|Randomized set|||Participants|||Number
1467071|NCT00727506|Secondary|Number of Participants With MGMT Marker Assessed by IHC Test.|Number of participants with MGMT marker assessed by IHC test for evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for O6-methylguanine-DNA methyltransferase (MGMT) by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1467072|NCT00727506|Secondary|Number of Participants With EGFRvIII Assessed by IHC Test.|Number of participants with the epidermal growth factor receptor variant III (EGFRvIII) assessed by IHC test for the evaluation of molecular determinants of response to afatinib. Archival tumor samples from enrolled patients were collected and analyzed for EGFRvIII by immunohistochemistry (IHC) test.|Baseline (during screening)|Randomized set|||Participants|||Number
1467073|NCT00727506|Secondary|Phase II - Trough Plasma Concentration of Afatinib|Trough plasma concentration of afatinib after multiple administration of 40 mg afatinib administered as monotherapy or in combination with 75 mg/m² temozolomide|Before (-0.05 h) the drug administration of afatinib on Day 15 of Cycle 2 & 3|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467074|NCT00727506|Secondary|t1/2 for Temozolomide|terminal half-life (t1/2) of temozolomide in presence and absence of afatinib|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||hours||Geometric Coefficient of Variation|Geometric Mean
1467075|NCT00727506|Secondary|Tmax for Temozolomide|time from dosing to the maximum plasma concentration following the first dose of uniform intervals τ (tmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||h||Full Range|Median
1467076|NCT00727506|Secondary|Cmax for Temozolomide|maximum measured plasma concentration following the first dose of uniform intervals τ (Cmax) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467077|NCT00727506|Secondary|AUC (0-8) for Temozolomide|Area under the plasma concentration-time curve over the time interval from zero to 08h (AUC (0-8)) of temozolomide in presence and absence of afatinib.|Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1|PKS set|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1467078|NCT00727506|Secondary|Tmax,ss for Afatinib|time from dosing to the maximum plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set|||hour||Full Range|Median
1467092|NCT00727311|Primary|Number of Participants With Early Virologic Response (EVR)|"EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA~negativity from baseline to Week 12"|Treatment Week 12|Number of evaluable participants at 12 weeks of treatment|||Participants|||Number
1467079|NCT00727506|Secondary|Cmax,ss for Afatinib|maximum measured plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide.|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS set|||ng/mL||Standard Deviation|Geometric Mean
1467080|NCT00727506|Secondary|AUCτ,ss for Afatinib|Area under the plasma concentration-time curve of afatinib after multiple administration (AUCτ,ss) of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide (TMZ).|Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24 h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1|PKS Set and the patients who had enough PK samples for calculation of AUC. Pharmacokinetic set (PKS) : All patients who provided at least one blood sample were included in the Pharmacokinetic (PK) analysis.|||ng·h/mL||Standard Deviation|Geometric Mean
1467081|NCT00727506|Secondary|Progression-free Survival (PFS)- Phase II Part|Progression-free survival was defined as the duration between randomization and the date of the first of the two following events: progression or death.|from date of randomization until the date of first documented progression or death by any cause, whichever came first, assessed up to 9 Months.|Randomized set|||Months||Full Range|Median
1467082|NCT00727506|Secondary|Objective Tumor Response in Phase II|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review. Only data collected until cut-off date July 15, 2016 were considered.|From randomization to until the date of first documented progression or data cutoff on July 15, 2016, whichever came first, with a mean treatment duration of 110.0 days|RS|||participants|||Number
1467083|NCT00727506|Secondary|Objective Tumor Response in Phase I|Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review.|From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.|Patients treated in Phase I part|||participants|||Number
1467084|NCT00727506|Primary|Progression-free Survival (PFS-6) at Six Months - Phase II|"PFS-6 is defined as probability of patients surviving to six months after randomization without progression. Disease progression was evaluated by an independent review committee and by the investigators, independently. The evaluation by the independent review committee was used for the primary outcome measure. The measurement Number the estimated PFS-6 value from the Kaplan-Meier curve of PFS."|At six months after randomization|Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment in the Phase II part of the trial.|||probablity of survival||95% Confidence Interval|Number
1467085|NCT00727506|Primary|Number of Participants With DLT- Phase I|Number of Participants With Dose Limiting Toxicities (DLT) - Phase I Part|From randomization till data cut-off (10 Jun 2009), with a mean treatment duration of 51 days||||participants|||Number
1467086|NCT00727402|Primary|Cumulative Incidence of Corneal Inflammatory Events|Unadjusted cumulative incidence of corneal inflammatory events (CIE)using survival analysis methods. CIE are corneal infiltrates found in an otherwise clear cornea.|annual||||annual incidence per 100 subjects|Participants|95% Confidence Interval|Mean
1467087|NCT00727337|Secondary|Hearing Handicap Inventory for the Elderly (HHI) Change|The HHI is a 25-item questionnaire that assesses the social and emotional consequences of hearing loss. The HHI for the elderly is for individuals age 65 years and older (Ventry & Weinstein 1982); the HHI for adults is for individuals aged 64 years and younger (Newman et al. 1990). The versions differ in the wording of three questions. The participants were asked to complete the appropriate HHI for aided listening to reflect their residual hearing handicap. HHI items are answered on a scale of Yes (4 points), Sometimes (2 points) and No (0 points), with higher scores indicating greater reported hearing handicap. Total HHI scores, which can range from 0 to 100, were used for all analyses.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||units on a scale||Standard Deviation|Mean
1467088|NCT00727337|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB) Change|The Abbreviated Profile of Hearing Aid Performance (APHAP; Cox & Alexander 1995) was used to assess activity limitations and the Hearing Handicap Inventory for the Elderly or Adults (HHI; Ventry & Weinstein 1982; Newman et al. 1990) was used to assess participation restrictions. The APHAP is a 24-item questionnaire that documents hearing difficulties in specified listening situations. The items are answered on a 7-point scale from ‘Always’ (or 99%) to ‘Never’ (or 1%) with higher scores indicating greater reported hearing difficulty. The APHAP global score that ranges from 1 to 99 was used for all analyses.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||units on a scale||Standard Deviation|Mean
1467089|NCT00727337|Primary|Words-in-Noise Test (WIN) Change|Monosyllabic words (NU-6 female version) with a carrier phrase were presented auditory only in a multitalker babble.The participant is asked to repeat the last word of each phrase. The total number of correct words is input into the Spearman-Karber equation to derive a 50% point. This is the signal-to-noise ratio in dB that an individual requires to get 50% of the words correct. This test was completed at baseline and follow up visits.|Baseline, immediate post-intervention (up to 2 to 6 weeks), 6 month follow up|Through the duration of the study, a total of 7 participants withdrew from LACE-DVD, 10 participants withdrew from LACE-C, 10 participants withdrew from Placebo, and 9 withdrew from the Control.|||dB SNR||Standard Deviation|Mean
1467090|NCT00727311|Primary|Number of HCV-RNA Negative Participants at Follow-up|HCV-RNA was measured by PCR.|24 weeks post-treatment (Weeks 48 or 72, depending on genotype)|Number of participants with results at the 6 month follow-up examination|||Participants|||Number
1467091|NCT00727311|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT|24 weeks post-treatment (Week 48 or 72, depending on genotype)|Number of evaluable participants with follow-up information|||Participants|||Number
1467103|NCT00727220|Primary|Change in HgBA1c||Baseline and 6 months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
1467093|NCT00727311|Primary|Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT)|HCV-RNA level was measured by polymerase chain reaction (PCR).|24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6|Number of evaluable participants at EoT|||Participants|||Number
1467094|NCT00727298|Secondary|Clinicians' Impression of Therapeutic Efficacy|Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.|Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.|||Percentage of Participants|||Number
1467095|NCT00727298|Secondary|Clinicians' Impression of Disease Severity From Baseline to Week 102|Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.|Baseline, Week 6, Week 14, Week 22, Week 54, Week 102|The efficacy evaluable population consisted of all participants with baseline data available that received at least 3 infusions of study drug within 14+2 weeks.|||Percentage of Participants|||Number
1467096|NCT00727298|Primary|Number of Participants Experiencing at Least One Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.|Baseline to Month 24|The safety evaluable population consisted of all participants with that received at least one infusion of infliximab.|||Participants|||Number
1467097|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1467098|NCT00727272|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1467099|NCT00727272|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic blood samples drawn within one hour prior to dosing (hour 0) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after dose administration.|Data for 26 of the 27 subjects were used in the statistical analysis for Treatments A and C. The data for one subject, who dropped from the study prior to period III dosing (Treatment B), was included in the comparison of Treatments A versus C. Treatment A, Dose Adjusted to 300 mg was used to evaluate for dose proportionality.|||ng/mL||Standard Deviation|Mean
1467100|NCT00727259|Primary|Evaluation of the Satisfaction of the PegPen (PegIntron Preparation and Injection Easiness) Using a Patient Questionnaire Answered at 1 Month and 3 Months|Patient satisfaction for each item on the questionnaires was rated on a scale from 0 (not satisfied) to 7 (very satisfied).|The patient was instructed to answer and return by mail the first self-questionnaire after 1 month of treatment and the second one after 3 months of treatment.|Both patient questionnaires were returned by 940 subjects. However, some items were not rated on the returned questionnaires. The missing data for questionnaire items range from 24 subjects to 72 subjects.|||satisfaction rating from 0-7||Standard Deviation|Mean
1467101|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Unmatched Healthy Controls|A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. Higher T-scores indicate higher levels of cognitive functioning. Due to the small number of subjects in this study, this second analysis was completed using the same number of subjects in the TBI and control groups, but without matching so that a slightly larger number of subject's data could be utilized. Although analyses were run, due to the very small number of participants in this study, results should be considered with caution.|6 weeks|cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. See note above related to the limited number of subjects in each group.|||T-score||95% Confidence Interval|Mean
1467102|NCT00727246|Primary|Cognitive Composite Score for Group of Subjects With TBI and Healthy Controls Matched by Age, Education, and Treatment Group.|.A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. A higher T-score indicates a higher level of cognitive function. Due to matching criteria of age range, gender and education level, as well as the small number of subjects with TBI who complete the study (n = 5), matched groups required a reduction to 2 subjects per group for analysis as planned per protocol. Due to the small number of subjects in this study overall, although analyses were run, results should be considered with caution.|6 weeks|A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of subjects with TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. Matching criteria and small n for TBI group reduced group sizes.|||T-score||95% Confidence Interval|Mean
1467104|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Ptosis)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.|||units on a scale||Standard Deviation|Mean
1467105|NCT00727194|Secondary|Change From Baseline to the End of Treatment (16 Weeks) in the Two Most Affected QMG Items for Disease Severity (Individual Test Item: Double Vision)|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG. All individual QMG items are scored 0 to 3, with 3 being the most severe. Negative values imply an improvement in QMG Item Score.|16 weeks|The Investigators selected the 2 most affected items (double vision, ptosis) out of the 13 items in the QMG scoring system for each of their patients based on their clinical evaluation at Baseline. The count is provided when the item was selected as the most affected by the Investigator, for participants who were treated in the respective sequence.|||units on a scale||Standard Deviation|Mean
1467106|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Negative Inspiratory Force. NIF is a measurement of respiratory muscle strength and ventilator reserve. NIF is represented by centimeters of water pressure (cmH2O). A normal NIF measurement is negative 60 cmH2O, or as 100% predicted value.|16 weeks|Comparison of NIF at the Last Visit Between Eculizumab and Placebo Cohorts.|||percentage of predicted||Standard Deviation|Mean
1467107|NCT00727194|Secondary|Change From Baseline in Respiratory Function Tests to Characterize the Degree of Involvement of Respiratory Muscles.|Change from Baseline in Forced Vital Capacity|16 weeks|Comparison of FVC at the Last Visit Between Eculizumab and Placebo Cohorts.|||percentage of predicted||Standard Deviation|Mean
1467108|NCT00727194|Secondary|Change From Baseline in the QoL Instrument, SF-36.|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (physical functioning, role-physical, bodily pain, general health, mental health, role-emotional, social functioning and vitality) as well as psychometrically-based physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group. The lower the score the more disability; the higher the score the less disability. Norm-based scoring involving a linear T-score transformation method was used so that scores for each of the health domain scales and component summary measures have a mean of 50 and a standard deviation of 10 based on the 1998 US general population. Thus, scores above and below 50 are above and below the average, respectively, in the 1998 US general.|16 weeks|Comparison of SF-36 at the Last Visit Between Eculizumab and Placebo Cohorts.|||units on a scale||Standard Deviation|Mean
1467109|NCT00727194|Secondary|Change From Baseline in the MG-Activity of Daily Living Profile (MG-ADL)|The MG-ADL is an 8-point questionnaire that focuses on relevant symptoms and functional performance of activities of daily living (ADL) in MG patients. The 8 items of the MG-ADL were derived from symptom-based components of the original 13-item QMG to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL score is 0 – 24. MG-ADL was to be performed at every study visit. The recall period for MG-ADL was since the preceding study visit (1 or 2 weeks).|16 weeks|Comparison of MG Activities of Daily Living (Total score) at the Last Visit Between Eculizumab and Placebo Cohorts.|||units on a scale||Standard Deviation|Mean
1467110|NCT00727194|Secondary|Change From Baseline in the MGFA Post-Intervention Status (PIS)|The MGFA PIS is designed to assess the clinical state of MG patients at any time after treatment of MG is initiated. Change in status categories of Improved, Unchanged, Worse, Exacerbation, and Died of MG was to be assessed and recorded at every visit from Visits 3 to 24 (Weeks 1 to 16). Minimal manifestations were to be assessed at these visits.|16 weeks||||participants|||Number
1467111|NCT00727194|Secondary|Mean Change From Baseline in QMG Total Score|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The Myasthenia Gravis Foundation of America task force has recommended that the QMG score be used in prospective studies of therapy for MG. The QMG scoring system consists of 13 items. Each item is graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0-39.|16 weeks||||units on a scale||Standard Deviation|Mean
1467112|NCT00727194|Primary|Quantitative Myasthenia Gravis (QMG): The Primary Efficacy Endpoint in This Study Was the Percentage of Patients With a 3-point Reduction From Baseline in the QMG Total Score for Disease Severity.|The QMG scoring system is considered to be an objective evaluation of muscle strength based on quantitative testing of sentinel muscle groups. The MGFA task force has recommended that the QMG score be used in prospective studies of therapy for MG.|16 weeks||||percentage of patients|||Number
1467113|NCT00727090|Secondary|Glasgow Coma Scale|Standardized examination of mental status ranging from 3 (worst) to 15 (best possible)|48 hours|||||||
1467114|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 48 Hours||48 hours||||mMol/L||Standard Deviation|Mean
1467115|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 36 Hours||36 hours||||mMol/L||Standard Deviation|Mean
1467116|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 24 Hours||24 hours||||mMol/L||Standard Deviation|Mean
1467117|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 18 Hours||18 hours||||mMol/L||Standard Deviation|Mean
1467118|NCT00727090|Other Pre-specified|Change in Serum Sodium From Baseline to 12 Hours||12 hours||||mMol/L||Standard Deviation|Mean
1467119|NCT00727090|Secondary|NIH Stroke Scale|Standardized neurologic examination, ranging from 0 (best) to 42 (worst possible).|48 hours|||||||
1467121|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of DVS SR by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
1467122|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of Desvenlafaxine Succinate Sustained-Release (DVS SR) by Metabolizer Status|Cmax is a measure of drug metabolism and is presented as least squares geometric mean with 90% Confidence Interval.Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
1467123|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
1467124|NCT00727064|Primary|Maximum Concentration (Cmax) of Desvenlafaxine After Single Dose of VEN ER by Metabolizer Status|Cmax is a measure of drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
1467125|NCT00727064|Primary|Area Under the Concentration-time Curve (AUC) of Venlafaxine After Single Dose of VEN ER by Metabolizer Status|AUC is drug level over time and measures drug metabolism. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng*h/mL (90% CI)||90% Confidence Interval|Geometric Mean
1467126|NCT00727064|Primary|Maximum Concentration (Cmax) of Venlafaxine After Single Dose of Venlafaxine Extended-release (VEN ER) by Metabolizer Status|Cmax is a measure of drug metabolism and presented as least squares geometric mean with 90% Confidence Interval. Variations in drug metabolism among individuals can be due to differences in genetic expression (phenotype) of Cytochrome P450 (CYP450) enzymes. Enzyme CYP2D6 has 4 metabolizer phenotypes: poor (PM), intermediate (IM), extensive (EM), and ultrarapid (UM) metabolizers.|single dose|All participants from sequence groups A and B who received a single dose of venlafaxine ER.|||ng/mL (90% CI)||90% Confidence Interval|Geometric Mean
1467127|NCT00727025|Primary|Time to Perform Wound Closure|Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture|intraoperatively|those who completed application of devices intraoperatively|||minutes||Standard Deviation|Mean
1467128|NCT00727025|Secondary|Patient Postoperative Incisional Comfort|Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable|10 days||||units on a scale||Standard Deviation|Mean
1467129|NCT00727025|Primary|Scar Quality at 6 Months Postoperative|Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.|6 months||||units on a scale||Standard Deviation|Mean
1467130|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 2||||mg/kg/h||Standard Deviation|Mean
1467131|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)||Day 1||||mg/kg/h||Standard Deviation|Mean
1467132|NCT00726999|Secondary|Side Effect Occurrence|The number of episodes of/occurrence of side effects was monitored in both groups.|First 10 days after surgery|||||||
1467133|NCT00726999|Primary|Amount of Morphine Consumed (mg/kg/hr)|Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.|PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)||||mg/kg/h||Standard Deviation|Mean
1467134|NCT00726986|Secondary|Safety|Number of patients that experienced grade 3-4-5 treatment related toxicities. Toxicity was graded by the National Cancer Institute Common Terminology Criteria version 3.0.|Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity.|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||participants|||Number
1467135|NCT00726986|Secondary|Response Rate|"The Response Evaluation Criteria in Solid Tumors (RECIST) were used to assess response to the treatment.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started"|reevaluated for response every 8 weeks|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||participants|||Number
1467136|NCT00726986|Secondary|Median Overall Survival|Overall survival is measured from the date of chemotherapy treatment (date of cycle 1 of induction chemotherapy) until death and censored at the date of last follow-up for survivors.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||months||95% Confidence Interval|Median
1467137|NCT00726986|Primary|Progression-free Survival(PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.|1-year|Patients who received at least one dose of the study drug were considered evaluable for both toxicity and response.|||months||95% Confidence Interval|Median
1467138|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1467139|NCT00726895|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng-hr/mL||Standard Deviation|Mean
1467140|NCT00726895|Primary|Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Plasma concentration data for 23 of the 24 enrolled subjects were used in the statistical analysis. Subject number 12 dropped from the study prior to period II (Treatment A) dosing. Treatment A, Dose Adjusted to 2 x 324 mg was a statistical adjustment only used to evaluate for dose proportionality.|||ng/mL||Standard Deviation|Mean
1467141|NCT00726882|Secondary|Number of Participants With Serious Adverse Events Related to Study Procedures|Only serious adverse events that the investigator considered causally related to study procedures (i.e., venipuncture) were to be collected in this study. A serious adverse event was defined as any untoward medical occurrence in a clinical investigation subject that the investigator believed to be causally related to a study procedure and met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|48 weeks||||participants|||Number
1467142|NCT00726882|Primary|Persistence of Resistance-Associated Variants and Phenotypic Resistance|Participants in studies M10-351 (NCT00851890) and M10-380 (NCT00696904) were analyzed for persistence of resistance-associated variants by comparing post-treatment clonal sequence data with baseline and on-treatment sequence data from M10-351 and M10-380 studies to assess amino acid changes. Phenotypic resistance to ABT-333 was assessed by calculating the fold change in half maximal effective concentration (EC50) of post-treatment samples compared with the EC50 value for the corresponding baseline sample as determined for M10-351 and M10-380 studies. The number of participants with variants at resistance-associated amino acid positions and phenotypic resistance at post-treatment time points are presented. Variants are included if the absolute percent of total clones encoding the variant was at least 10% greater than at baseline in a post-treatment sample.|Baseline (day of study completion or early discontinuation from the prior ABT-333 clinical study), 48 weeks|Resistance analyses included all participants who received ABT-333 in the previous study who had sufficient HCV RNA recovered from samples collected during this study for genotypic and phenotypic analysis to proceed. m, n = the number of evaluable participants for the analysis specified for M10-380 and M10-351, respectively.|||participants|||Number
1467143|NCT00726830|Secondary|Number of Participants With 30% Reduction in Total Summary Score for the Individual Composite Drug Toxicity Score (CDTS) Items||28 days|||||||
1467144|NCT00726830|Primary|Number of Participants With at Least a 3-point Reduction in Pain Score on the M.D. Anderson Symptom Inventory (MDASI)|MDASI questionnaire completed on days 8, 15, and 22 after enrollment. The ‘primary success’ is defined as a 3-point reduction in pain score on the MDASI. Scores from baseline and from four weeks later compared using the MDASI average pain intensity on a scale of 0 (no pain) to 10 (worst pain).|28 days|No Analysis accomplished as there is not sufficient participant data to meet the study end points.||||||
1467145|NCT00726752|Secondary|Number of Participants With Adverse Events|Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 3 or higher , serious adverse events, and adverse events resulted in discontinuation.|Up to 470 days of treatment plus 28-days follow-up|Safety analysis set was defined as all enrolled participants who received the study drug at least once in this study (same as the full analysis set:FAS).|||participants|||Number
1467146|NCT00726752|Secondary|Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression of Disease (PD) According to the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)|CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as PD being demonstrated during the first 8 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.|Up to 470 days|Anti-tumor response analysis set was defined as all participants with at least 1 target lesion according to RECIST and who received at least 1 dose of study drug.|||participants|||Number
1467147|NCT00726752|Secondary|Percent Change From Baseline in Soluble Vascular Endothelial Growth Factor Receptor 1, 2, and 3 (s-VEGFR1, s-VEGFR2 and s-VEGFR3), Vascular Endothelial Growth Factor (VEGF), Soluble Stem Cell Factor Receptor (s-KIT )|Percent change from baseline is obtained from (observed value minus baseline value) divided by baseline value multiplied by 100 in each parameter, i.e., s-VEGFR1, VEGFR2, s-VEGFR3, s-KIT, and VEGF|Prior to the initial dose (baseline) and Day 1 of Cycle 2|Pharmacodynamic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacodynamic blood sampling for at least 1 day.|||percent||Full Range|Median
1467148|NCT00726752|Secondary|Multiple Dose: Accumulation Ratio for Cmax (Rac Cmax) and Accumulation Ratio for AUCtau (Rac AUCtau)|Rac Cmax is obtained from Cmax (Cycle 1, Day 15) divided by Cmax (Cycle 1, Day 1) Rac AUCtau is obtained from AUCtau (Cycle 1, Day 15) divided by AUCtau (Cycle 1, Day 1)|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ratio||Standard Deviation|Mean
1467149|NCT00726752|Secondary|Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Full Range|Median
1467150|NCT00726752|Secondary|Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The dosing interval was 12 hours in this study.|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng*h/mL||Standard Deviation|Mean
1467151|NCT00726752|Secondary|Multiple Dose: Maximum Observed Plasma Concentration (Cmax)|Cmax at multiple dosing|Cycle 1 Day 15 predose in the morning, and 0.5, 1, 2, 4, 8 and 12 hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng/mL||Standard Deviation|Mean
1467152|NCT00726752|Primary|Single Dose: Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Standard Deviation|Mean
1467153|NCT00726752|Primary|Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||hours||Full Range|Median
1467154|NCT00726752|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time Infinity (AUCinf)|AUCinf is obtained from AUC (0 - t) plus AUC (t - infinity).|Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng*hr/mL||Standard Deviation|Mean
1467155|NCT00726752|Primary|Single Dose: Maximum Observed Plasma Concentration (Cmax)||Predose, 0.5, 1, 2, 4, 6, 8, 10, 24, and 32-hour postdose|Pharmacokinetic analysis set was defined as all enrolled participants who received at least 1 dose of the study medication and who completed pharmacokinetic blood sampling for at least 1 day.|||ng/mL||Standard Deviation|Mean
1467156|NCT00726739|Secondary|Immune Response|Immune responses is be assessed by Delayed Type Hypersensitive (DTH) responses to LMI, IFN-γ production by CD8 T cells using the ELISPOT assay, and CD8 T cell binding to HLA-A2 multimers complexed with melanoma-derived peptides (pentamer analysis). DTH reactions are determined at 48 hours by measuring the largest diameter and right angle diameter of the area of induration and calculating the mean. DTH responses are recorded as present or absent but cannot be used as a quantitative measure of immune activation.|48 hours After Study Medication||||participants|||Number
1467157|NCT00726739|Secondary|Overall Survival at 1 Year|One year survival (alive at 1 year from randomization) rate of each treatment group.|1 Year||||Percentage of patients|||Number
1467158|NCT00726739|Secondary|Overall Survival at 2 Years|Two year survival (alive at 2 years from randomization) rate of each treatment group.|2 Years||||percentage of patients|||Number
1467159|NCT00726739|Secondary|Clinical Response of Lesion(s)|Beginning at 2 months Through End of Treatment: To determine clinical response of each treatment group - Best Clinical response will be determined using Solid Tumor Response Criteria (RECIST). Complete Response (CR) = complete disappearance of all target lesions. Partial Response (PR) = At least a 30% decrease in sum of longest diameters of target lesions. Progressive Disease (PD) = At least a 20% increase in sum of longest diameters of target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR or PD.|Month 2 through Month 12|All patients who received at least one dose of study treatment are included. One patient who was originally screened did not receive treatment due to brain metastasis.|||participants|||Number
1467160|NCT00726739|Primary|Median Time of Progression-free Survival|Progression free survival (PFS) was measured in months from date of randomization to date of disease progression, or date of death. For patients who died without tumor progression, PFS assumes their deaths are randomly related to tumor progression. Therefore, PFS includes deaths if they came first.|From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.|All patients who received at least one dose of study treatment are included. One patient who was originally screened and randomized did not receive treatment due to brain metastasis. This patient was included in PFS analysis based on the intent-to-treat principle, but was excluded from the evaluation of adverse events.|||Months||Full Range|Median
1467161|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including Potential Antioxidant (PAO)|Analyte levels were taken at 0 (Baseline) and 24 weeks||||µmol/L||Standard Deviation|Mean
1467162|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including hs-CRP|Analyte levels were taken at 0 (Baseline) and 24 weeks||||mg/L||Standard Deviation|Mean
1467163|NCT00726713|Secondary|Change From Baseline in Total Homocysteine at Week 16 and 24|To determine if Metanx® (compared to placebo) affects change in subjects total homocysteine levels|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks||||µmol/L||Standard Deviation|Mean
1467512|NCT00724815|Secondary|Phonophobia Free at Two Hours|Subjects who were phonophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1467164|NCT00726713|Secondary|(Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24|The Hospital Anxiety and Depression Scale (HADS) consists of a 14-item questionnaire that provides a measurement of depression. Each item is rated on a 4-point scale, giving a maximum scores of 21 for the most severe depression. Depression was evaluated using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, and 24-week evaluation visits|HADS Scores scores were taken at 0 (Baseline) and 24 weeks||||units on a scale (0-21)||Standard Deviation|Mean
1467165|NCT00726713|Secondary|(Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24|(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory marker levels, including IL-6 and TNF-α|Analyte levels were taken at 0 (Baseline) and 24 weeks||||pg/mL||Standard Deviation|Mean
1467166|NCT00726713|Secondary|Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s lower extremity pain level using a 10-point Visual Analog Scale at Baseline and 24-week evaluation visits.~The Visual Analog Scale (VAS) measures a patients sensation of pain. A 10-cm visual analog scale is used. A measurement on the 10 cm analog scale is used to quantify the level of pain indicated with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable."|VAS scores were taken at 0 (Baseline) and 24 weeks||||units on a scale (0-10)||Standard Deviation|Mean
1467167|NCT00726713|Secondary|Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24|"To determine if Metanx® (compared to placebo) affects a subject’s “quality of life” as determined by the SF-36 questionnaire~The Short Form- 36 Mental Component Summary (SF-36 MCS) and SF-36 Physical Component Summary (SF-36 PCS) both measure health related quality of life, the MCS quantifying mental health and the PCS quantifying physical function. They are both scored on 100 point scales with 0 representing the worst possible outcome and 100 representing the most optimal possible scoring"|SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks||||units on a scale (0-100)||Standard Deviation|Mean
1467168|NCT00726713|Secondary|Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24|To determine if Metanx® (compared to placebo) affects a change in subject's total folate and total methyl malonic acid (MMA) at week 16 and 24|Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks||||nmol/L||Standard Deviation|Mean
1467169|NCT00726713|Secondary|Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24|"This outcome was taken to determine if Metanx® (compared to placebo) has an effect on clinical examination as determined by the Neuropathy Disability Score (NDS)~The Neuropathy Disability Score (NDS) evaluates the severity of individual symptoms of neuropathy. A simple visual numeric distress scale is used that ranges from 0 to 10. The most favorable score is 0, which indicates an absence of symptoms. The most severe symptoms possible would be recorded as a score of 10."|NDS scores were taken at 0 (Baseline), 16, and 24 weeks||||units on a scale (0-10)||Standard Deviation|Mean
1467170|NCT00726713|Secondary|Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)|"This measure was taken to determine if Metanx® (compared to placebo) changes neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)~The Neuropathy Total Symptom Score-6 Scale (NTSS-6) is a validated scale that evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). This scale was a modified 6 item scale that consists of yes or no questions. Scores range between 0 and 21.96, a higher score indicates greater severity of symptoms. After adjusting for baseline measurements scores are reflected as negative numbers. Negative numbers indicate improvement in symptoms. ie. a change from baseline after 24 weeks of -2 would be a greater improvement than a change in baseline of -1 after 24 weeks."|NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks||||units on a scale (0-6)||Standard Deviation|Mean
1467171|NCT00726713|Primary|Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks|Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes.|VPT was measured a 0 (baseline), and 24 weeks||||volts||Standard Deviation|Mean
1467172|NCT00726661|Secondary|Number of Participants With Arterial Thromboembolic Events, Venous Thromboembolic Events, Left Ventricular Systolic Dysfunction, and Peripheral Neuropathy|All AEs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 as Grade 1 (mild), Graded 2 (moderate), Grade 3 (severe), Grade 4 (very severe, life threatening, or disabling), and Grade 5 (death related to AE). Venous Thromboembolic Events (VTEs) included all Grade 4 or of more severity of deep vein thrombosis, pulmonary embolus; Arterial Thromboembolic Events (ATEs) Included new or worsening angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral arterial ischemia of any NCI CTCAE grade; Left Ventricular Systolic Dysfunction (LVSD) included congestive heart failure) of NCI CTCAE Grade 2 or of more severity; Peripheral Neuropathy (PN) included sensory and/or motor events of Grade 3 or of more severity.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
1467173|NCT00726661|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, Any AEs Leading to Early Treatment Discontinuation, and Adverse Events Leading to Hospitalization or Death|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
1467174|NCT00726661|Secondary|Number of Hormone Receptor-positive Participants Who Initiated Cytotoxic Chemotherapy Following Discontinuation|Participants were assessed quarterly for progressive events and treatment status.|Approximately 4.5 years|All enrolled participants in Hormonal Therapy Cohort were considered for this outcome measure. n = number of participants evaluated at that particular time point.|||participants|||Number
1467299|NCT00725608|Secondary|Dosing of Suboxone (Buprenorphine Plus Naloxone)|One of the secondary objectives was to evaluate the effect of the switch to buprenorphine/naloxone on medication dispensing measured by dose.|day 1, month 6, month 12|All participants with eligible datasets were included in the final analysis|||Dose of Suboxone® in mg||Standard Deviation|Mean
1467175|NCT00726661|Secondary|Number of Participants With Tumor Response|The tumor response was measured as complete response, partial response, stable disease, progressive disease, or clinical deterioration based on their best overall response. The tumor response was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
1467176|NCT00726661|Secondary|Overall Survival|Overall survival was defined as the time from enrolment to death of any cause.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
1467177|NCT00726661|Primary|Progression Free Survival|Progression free survival was defined as the time from enrollment to progression or death of any cause, whichever came first. The disease response status was assessed by the investigator according to the method of his or her choice. The choices included computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, X-ray, Positron emission tomography (PET) or CT PET, physical exam, laboratory exam, and other method.|Approximately 4.5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
1467178|NCT00726622|Secondary|Bowel and Stoma Function||Up to 5 years post surgery|||||||
1467179|NCT00726622|Secondary|Bowel Function||Up to 5 years post surgery|||||||
1467180|NCT00726622|Secondary|Quality of Life and Sexual Function||Up to 5 years post surgery|||||||
1467181|NCT00726622|Secondary|Overall Survival||Up to 5 years post surgery|||||||
1467182|NCT00726622|Secondary|Local Pelvic Recurrence Rates||Up to 2 years post surgery|||||||
1467183|NCT00726622|Secondary|Disease-free Survival||Up to 2 years post surgery|||||||
1467184|NCT00726622|Secondary|Operative Times|Open to close operative time.|During surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||minutes||Standard Deviation|Mean
1467185|NCT00726622|Secondary|Use of Pain Medication|The number of days patients received parenteral narcotics post-surgery were counted.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||days||Standard Deviation|Mean
1467186|NCT00726622|Secondary|Length of Stay|The mean number of days required post-surgery to the when the patient was released from the hospital was calculated.|Two weeks post-surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||days||Standard Deviation|Mean
1467187|NCT00726622|Secondary|Circumferential Margin > 1 mm|The distance between the closest tumor to the cut edge of the tissue was measure post-resection. The percentage of patients with >1mm between the closest tumor to the cut edge of the tissue was calculated with a binomial 95% confidence interval.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1467188|NCT00726622|Secondary|Negative Distal Resected Margin|The percentage of patients with negative distal margin (>1 mm between the closest tumor to the cut edge of the tissue) was calculated along with binomial 95% confidence intervals.|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1467189|NCT00726622|Secondary|Completeness of Total Mesorectal Excision (Complete or Nearly Complete)|"Complete total mesorectal excision was defined as a rectal resection specimen having smooth surface of mesorectal fascia with all fat contained in the enveloping fascia to a level 5 cm below the tumor for tumor-specific total mesorectal excision for upper rectal cancer, or the entire mesorectal envelope present for low rectal cancer. Nearly complete was defined as a rectal resection specimen having the mesorectal envelope intact except for defects no more than 5 mm deep, with no loss of mesorectal fat.~The percentage of patients with complete or nearly complete mesorectal excision was calculated along with the binomial 95% CI."|At time of surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1467190|NCT00726622|Primary|Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation.|"The primary endpoint will be a composite endpoint of oncologic factors which are indicative of an adequate surgical resection based on pathologic evaluation.~Primary endpoint parameters:~Circumferential margin > 1 mm~Negative distal margin~Completeness of total mesorectal excision (TME) A complete TME is a rectal resection specimen that has an intact mesorectum and covering peritoneal envelope all the way to the level of rectal transection with no coning in of the mesorectum above the point of transection. The surface of the peritoneal covering should be smooth and shiny with no defects exposing the underlying fat.~All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior."|At time of Surgery|Of the 225 patients that received intervention as randomized in Arm 1: Open laparotomy and rectal resection, 3 patients were excluded from the analysis due to improper consent. All 240 patients from Arm 2 that received intervention as randomized were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1467303|NCT00725543|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||mg/kg||Full Range|Median
1467191|NCT00726609|Primary|Number of Participants Reporting Adverse Drug Reactions.|"The severity of an Adverse Drug Reaction is determined on the basis of the following definitions:~Mild: The abnormality, symptom or event is noticed but well tolerated.~Moderate: Symptoms impair normal activities and may require intervention.~Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required."|Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.||||Participants|||Number
1467192|NCT00726557|Primary|Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week|Tolerability of the treatment was measured by number of participants with complete treatment.|Assessed at the end of treatment|All enrolled participants|||participants|||Number
1467193|NCT00726557|Primary|Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions|Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).|End of Follow-up (Week 48 or Week 72, depending on genotype)|Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)|||Participants|||Number
1467194|NCT00726453|Secondary|Stent Thrombosis (ST)|Stent Thrombosis (ST) (as determined by historic and ARC definitions).|12 months||||percentage of participants|||Number
1467195|NCT00726453|Secondary|Target Vessel MI|Target Vessel MI (as determined by extended historical and ARC definitions).|12 months||||percentage of eligible participants|||Number
1467196|NCT00726453|Secondary|Death||12 months||||percentage of participants|||Number
1467197|NCT00726453|Secondary|Major Adverse Cardiac Event (MACE)|Major Adverse Cardiac Event (MACE) composite endpoint and each individual component (death, Target Vessel MI (Q wave and non-Q wave), emergent coronary bypass surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods).|12 months||||percentage of participants|||Number
1467198|NCT00726453|Secondary|Target Vessel Failure (TVF)|Target Vessel Failure (TVF) composite endpoint and each individual component (Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods).|12 months||||percentage of participants|||Number
1467199|NCT00726453|Primary|Target Lesion Failure (TLF)|Target Lesion Failure (TLF) at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically-driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.|12 Months||||percentage of participants|||Number
1467200|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Quinine Sulfate|The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng-hr/mL||Standard Deviation|Mean
1467201|NCT00726414|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Quinine Sulfate|The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng-hr/mL||Standard Deviation|Mean
1467202|NCT00726414|Primary|Maximum Plasma Concentration (Cmax) for Quinine Sulfate|The maximum or peak concentration that Quinine Sulfate reaches in the plasma.|serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36 and 48 hours after drug administration.|Data from all 22 subjects enrolled in this study were used in the statistical analysis.|||ng/mL||Standard Deviation|Mean
1467203|NCT00726375|Secondary|The Number of Patients in Complete Remission (CR) at Four Weeks.|"Estimate the proportion of patients in complete remission (CR) at four weeks who remain alive and never require additional therapy four weeks after the last dose of etanercept.~Complete remission is defined as the resolution of all manifestations of GVHD (Graft Versus Host Disease) within the first four weeks of treatment. All organs must have a Grade 0."|28 days||||patients|||Number
1467204|NCT00726375|Primary|The Percentage of Patients Who Progress Within 28 Days of Initiation of Etanercept Treatment|We hypothesized that treatment of grade 1 acute GVHD (Graft Versus Host Disease) with etanercept would reduce the proportion of patients who progressed to grade 2 to 4 acute GVHD within 4 weeks of diagnosis from 58%, historically observed at our institution, to 38%.|28 days||||percentage of patients|||Number
1467205|NCT00726323|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, and Deaths|Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 4 years|Safety population|||Participants|||Number
1467206|NCT00726323|Secondary|Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)|CTCAE gradation The worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for hemoglobin, leukocytes, platelets, percentage of lymphocytes, and percentage of neutrophils.|Up to 4 years|Safety population|||Participants|||Number
1467207|NCT00726323|Secondary|Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period|The worst case overall common terminology criteria for adverse events (CTCAE) grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases (ALT), aspartate aminotransferases (AST), Albumin, alkaline phosphatase (ALP), calcium, sodium, potassium, glucose, amylase, carbon dioxide, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. High (H) levels and low (L) levels were measured.|Up to 4 years|Safety population|||Participants|||Number
1467208|NCT00726323|Secondary|Overall Survival|Overall survival, which is defined as the time between the date of first dose of study drug and the date of death (due to any cause). For participants who were alive at the time of data cutoff, duration of overall survival was right censored at the date of last contact. Duration of overall survival = date of death/censoring - date of first dose +1. Percentiles and confidence intervals are calculated using Kaplan-Meier methods.|Up to 4 years|Safety population|||Months||95% Confidence Interval|Median
1467209|NCT00726323|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as the time between the date of first dose of study drug and the date of the first occurrence of one of the tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to disease progression, or disease progression as documented on the follow-up participants status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of stable disease was right censored at the date of the last available tumor measurement.|Up to 4 years|Safety population. All participants with Best overall response, not progressive disease were considered.|||Months||95% Confidence Interval|Median
1467210|NCT00726323|Secondary|Duration of Response (DOR)|Duration of response is defined as the time between the date of first response (later confirmed CR or confirmed PR) and the date of the first occurrence of one of the events as tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to any cause, disease progression as documented on the follow-up or participant status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of response was censored at the date of the last available tumor measurement.|Up to 4 years|Safety Population- All Objective Responders (those who did not reach an event by the time of data cut-off as defined in protocol)|||Months||95% Confidence Interval|Median
1467211|NCT00726323|Secondary|Time to Response (TTR) Over Period|Time to response is the time between the date of first dose of study drug and the date of first response (for participants who had overall responses that were later confirmed as CR/PR). For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the time to response was censored at the date of the last visit. The median time to response was not estimable in either of the dosing cohorts or in the overall safety population using the Kaplan-Meier method.|Up to 4 years|Safety population|||Months||95% Confidence Interval|Median
1467212|NCT00726323|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the time between the date of first dose of study drug and the date of the first occurrence of either tumor progression per RECIST or clinical assessment of progression as assessed by Investigator or Death due to any cause, whichever occurs the first. For participants who did not reach an event (disease progression or death) at the time of data cutoff, PFS was censored at the date of the last available tumor measurement. For participants who did not have any post-baseline tumor assessments, PFS was right censored at Day 1. For any participants who received subsequent anticancer therapy, PFS was right censored at the date of last adequate tumor assessment on or prior to the date of anticancer initiation. For any participants, who died or progressed after an extended follow-up, PFS was censored at the date of last adequate assessment prior to the extended loss to follow-up.|At the end of forth year|Safety population|||Months||95% Confidence Interval|Median
1467213|NCT00726323|Secondary|Disease Stabilization Rate Over Period|The percentage of participants for whom the best overall response was a confirmed PR, confirmed CR, or stable disease. Exact confidence intervals were obtained using the Clopper-Pearson method. Exact confidence intervals were obtained using the Clopper-Pearson method.|Up to 4 years|Safety population|||Percentage of participants||95% Confidence Interval|Number
1467214|NCT00726323|Primary|Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0|Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator’s assessment of the target and non target lesions.|At the end of forth year|The Safety population included all participants who passed the screening criteria, were enrolled in the study and received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1467215|NCT00726232|Secondary|Change From Baseline to Week 4 in Health-related Quality of Life|Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.|Baseline and Week 4 (Cycle 2, Day 1)|Intent to treat population.|||units on a scale||Standard Deviation|Mean
1467216|NCT00726232|Secondary|Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness."|Baseline and Week 4 (Cycle 2, Day 1)|Essential Thrombocythemia intent to treat population who had symptom scores > 0 at baseline and for whom data was available.|||participants||Standard Deviation|Mean
1467300|NCT00725608|Primary|Retention Rate|The primary objective of this study was to determine the retention rate of patients after 6 and 12 months of treatment with buprenorphine/naloxone measured by the percentage of patients remaining in the study|month 6, month 12|All eligible datasets were included in analysis population.|||percentage of patients||95% Confidence Interval|Number
1467217|NCT00726232|Secondary|Change From Baseline to Week 4 in Polycythemia Vera Symptoms|"Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.~For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats."|Baseline and Week 4 (Cycle 2, Day 1)|Polycythemia Vera intent to treat population who had symptom scores > 0 at baseline for whom data was available.|||scores on a scale||Standard Deviation|Mean
1467218|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 36 weeks (Cycle 10, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1467219|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 24 weeks (Cycle 7, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1467220|NCT00726232|Secondary|Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks|"The individual components of clinical response included:~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L~50% reduction in spleen size~Absence of palpable splenomegaly"|Baseline and 4 weeks (Cycle 2, Day 1)|Essential thrombocythemia intent to treat population. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1467221|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 36 (Cycle 10, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1467222|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 24 (Cycle 7, Day 1)|Polycythemia Vera intent to treat population for whom data was available. 'N' indicates the number of patients for whom data was available for each component.|||percentage of participants|||Number
1467223|NCT00726232|Primary|Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~Complete Clinical Response:~Platelet count < 400 x 10^9/L~White blood cell count < 10 x 10^9/L with normal differential and Hematocrit ≤ upper limit of normal~Absence of sustained (> 2 weeks) anemia or leucopenia based on institutional normal ranges~Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias)~Absence of palpable splenomegaly~Partial Clinical Response:~Platelet count < 400 x 10^9/L~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.|Essential thrombocythemia intent to treat population, including all patients who took at least 1 dose of study drug. One patient in the 50 mg QD group did not have a response assessment at Cycle 3, Day 1.|||percentage of participants|||Number
1467224|NCT00726232|Secondary|Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks|"The individual components of clinical response included:~Hematocrit (Hct) < 45% without phlebotomy~Absence of palpable splenomegaly~50% reduction in spleen size~Platelet count ≤ 400 x 10^9/L~White blood cell (WBC) count ≤ 10 x 10^9/L"|Baseline and Week 12 (Cycle 4, Day 1)|Polycythemia Vera intent to treat population for whom data was available.|||percentage of participants|||Number
1467225|NCT00726232|Primary|Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)|"For a confirmed response all criteria must have been sustained for at least 2 months.~CR:~Hematocrit < 45% in men and < 42% in women~No phlebotomy for 1 month~No palpable splenomegaly~White blood cells < 10 x 10^9/L with normal differential and platelets < 400 x 10^9/L~No sustained leucopenia or thrombocytopenia (>2 weeks)~No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss)~PR:~Hematocrit < 45% in men and < 42% in women~50% reduction in phlebotomy requirements from 6 months before treatment started~50% reduction in palpable splenomegaly"|Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3|Polycythemia Vera intent to treat population, including all patients who took at least 1 dose of study drug.|||percentage of participants|||Number
1467226|NCT00726180|Primary|Standard Immunohistochemistry and Allred Scores Were to be Used to Measure the Estrogen Receptor (ER) Response Rate in Patients With ER-negative/Low, and Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-positive Breast Cancer.||90 days|Only 1 patient was enrolled to this study, so no data was obtained.||||||
1467227|NCT00726063|Secondary|Prosthesis Survival and Procedural Success||3 years||2018-12-31|12/2018||||
1467228|NCT00726063|Primary|Integration Success of the Implant||1 year|Number of implants surviving (lack of mobility) at the end of the study (time of analysis)|||implants|Implants||Number
1467229|NCT00726037|Secondary|Optimal Time for Future Dendritic Cell Vaccine Administration|The goal is to define the optimal time with 95% sensitivity and 95% specificity for future dendritic cell vaccine administration|33 Days|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption||||||
1467230|NCT00726037|Primary|T-reg Suppression From a Fractionated Dose of Ontak in Patients With Metastatic Pancreatic Cancer|The duration of T reg suppression from a fractionated dose of Ontak in patients will be measured in patients with metastatic pancreatic cancer.|days 8, 12 ,19,26 and 33 post administration|Zero participants were analyzed, because the manufacturer withdrew support for the study due to a drug supply interruption||||||
1467231|NCT00725985|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. Number of participants with AEs includes number of participants with both serious adverse events (SAEs) and non-SAEs.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo) and had at least one safety assessment during the ITP.|||Participants|||Number
1467232|NCT00725985|Secondary|Number of Combined Unique Active (CUA) Lesions, New or Enlarging Time Constant 2 (T2) Lesions, and New or Persisting Time Constant 1 (T1) Gadolinium Enhanced (Gd+) Lesions Per Participant Per Scan|Number of CUA lesions, new or enlarging T2 lesions, and new or persisting T1 Gd+ lesions were measured by using magnetic resonance imaging (MRI) scans.|Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Lesions||Standard Deviation|Mean
1467233|NCT00725985|Secondary|Time to Develop Multiple Sclerosis (MS) Conversion According to the Revised McDonald Criteria (2005) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With McDonald MS|The McDonald criteria use dissemination in time and space established by magnetic resonance imaging (MRI) findings to provide a clinical diagnosis for MS. Dissemination in time is established by a new time constant 2 (T2) or gadolinium enhanced (Gd+) lesion found on a repeat MRI. Dissemination in space is established by the presence of any 3 of the following: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; greater than or equal to 1 infratentorial lesion; greater than or equal to 1 juxtacortical lesion; greater than or equal to 3 periventricular lesions. Kaplan-Meier estimates were provided for the cum. % of participants with McDonald MS over time.|Baseline up to Week 96|The ITT population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Cum. % of participants with McDonald MS|||Number
1467234|NCT00725985|Primary|Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS|Clinically definite multiple sclerosis (CDMS) according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (>=) 1 point if baseline EDSS was between >= 1.0 and less than or equal to (=<) 4.5; or >= 1.5 points if baseline EDSS was 0, or >= 0.5 if baseline EDSS >= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method.|Baseline up to Week 96|The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of ITP study medication (cladribine or placebo).|||Cum. % of participants with CDMS|||Number
1467235|NCT00725959|Secondary|Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions||two months|||||||
1467236|NCT00725959|Primary|Proportion of Condom Usage|number of times condom used divided by number of times person had sex in past 60 days|two months||||proportion of condom use||95% Confidence Interval|Mean
1467237|NCT00725920|Primary|Clinician Administered Posttraumatic Stress Disorder Scale|"The Clinician-Administered PTSD Scale (CAPS) [33] : is a structured interview developed to diagnose PTSD and rate its severity. It is comprised of 30-items to assess PTSD-related symptom frequency and severity. Total scores (sum of 3 clusters items) range from 0 to 136, with scores classified as follows: subclinical, from 0 to 19; mild, from 20 to 39; moderate, from 40 to 59; severe, from 60 to 79; extreme, 80 and above.~CAPS has 3 subscales characterized by the sum of all symptoms for each cluster: CAPS 1 (Revivesce/intrusive recolllections, 5 symptoms, score range: 0-28); CAPS 2 (avoidance, 7 symptoms, score range: 0-36); and CAPS 3 (hyperarousal, 5 symptoms, score range: 0-28).~CAPS scoring: each symptom scores range from 0 to 4, plus 0-2 scores for frequency, and 0-2 severity."|12 week||||Total CAPS score||Standard Deviation|Mean
1467238|NCT00725842|Secondary|Number of Participants With Positive HCV-RNA at 72 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 72 weeks post EOT with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA at Week 72 post EOT were considered late relapsers.|72 weeks post EOT|77 of 90 participants had a negative HCV-RNA at Week 24 post EOT. These 77 were then evaluated for relapse at Week 72 post EOT.|||participants|||Number
1467239|NCT00725842|Secondary|Assessment of Pre-treatment Risk Factors of Relapse in Participants With Sustained Virologic Response|Baseline risk factors included but were not limited to viral load, genotype 1a versus 1b, histology, treatment compliance, gender, age, and substance abuse. Sustained virologic response was defined as having negative HCV-RNA at 24 weeks post EOT. Relapse was defined as positive HCV-RNA.|Baseline and 24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.||||||
1467240|NCT00725842|Secondary|Number of Participants With Rapid Virologic Response (RVR), Early Virologic Response (EVR), or Slow Response Who Relapsed After Treatment|Negative HCV-RNA at Week 4 of treatment with Peg-IFN alfa-2b + ribavirin was considered RVR; negative HCV-RNA at Week 12 of treatment with Peg-IFN alfa-2b + ribavirin was considered EVR; negative HCV-RNA between Week 12 and the end of treatment with Peg-IFN alfa-2b + ribavirin was considered a slow response. For participants who achieved RVR, EVR, or slow response, the relapse rate at 24 Weeks post EOT was to be determined on this observational study; relapse was defined as positive HCV-RNA.|24 weeks post EOT|The planned analysis for this outcome measure was not performed due to insufficient enrollment.||||||
1467301|NCT00725543|Primary|Median Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Full Range|Median
1467302|NCT00725543|Primary|Mean Remicade Dose Per Participant||Maximum of 24 months|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Standard Deviation|Mean
1467241|NCT00725842|Primary|Number of Participants With Positive Hepatitis C Virus (HCV)-Ribonucleic Acid (RNA) at 24 Weeks Off-treatment|HCV-RNA virus levels were measured by polymerase chain reaction (PCR) assay 24 weeks post end of treatment (EOT) with Peg-IFN alfa-2b + ribavirin. Participants with positive HCV-RNA were considered relapsers.|24 weeks post end of treatment (EOT)|Of the 97 participants who started the study, 7 were excluded from analysis because of protocol violations. 90 participants underwent HCV-RNA testing at Week 24 post EOT.|||participants|||Number
1467242|NCT00725764|Secondary|Apparent Volume of Distribution|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent volume of distribution was not derived as pharmacokinetic analysis was not completed. Data was not collected for PK analysis.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1467243|NCT00725764|Secondary|Apparent Oral Clearance|Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). Data for apparent oral clearance was not derived as pharmacokinetic analysis was not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1467244|NCT00725764|Secondary|Elimination Half-life (t1/2) of Foretinib in Participants With SCCHN|t1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples were planned to be obtained during indicated time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1467245|NCT00725764|Secondary|Area Under the Concentration-time Curve (AUC) of Foretinib in Participants With SCCHN|AUC was defined as area under the plasma concentration vs. time curve. Blood samples were planned to be collected on time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1467246|NCT00725764|Secondary|Time to Maximum Plasma Concentration (Tmax) of Foretinib in Participants With SCCHN|tmax was defined as the time to the maximum or “peak” concentration of a drug observed after multiple administration. Blood samples were planned to be obtained during the time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing). However these analyses were not completed. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1467247|NCT00725764|Secondary|Maximum Plasma Concentration (Cmax) of Foretinib in Participants With Squamous Cell Carcinoma of the Head and Neck (SCCHN)|Plasma samples for pharmacokinetic analysis were planned to be drawn at time points: Day 1, 5, 19, 33, 43, 47 (approximately 15 minutes before dosing, and at 4 hours (±30 minutes) after dosing) of each treatment cycle, however these analyses were not completed. Cmax was defined as maximal measured plasma concentration over the time span specified. Data was not collected for this endpoint.|Day 1, 5, 19, 33, 43, 47 (pre-dose15 min) and 4 h (± 30 min) post-dose|Safety population. Data was not collected for this endpoint.||||||
1467248|NCT00725764|Secondary|Percentage Participants With Disease Stabilization Rate|Disease stabilization rate was defined as the proportion of participants for whom the best overall response was a PR, CR, or stable disease. percentage participants with disease stabilization rate were presented.|Approximately up to 1 year|Safety Population|||percentage of participants||95% Confidence Interval|Number
1467249|NCT00725764|Secondary|Duration of Stable Disease|Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Duration of stable disease was defined as the time between the date of first dose of study drug and the first occurrence of 1 of the events: Tumor progression per RECIST as assessed by the investigator, Termination of study drug because of disease progression, Death due to disease progression, Disease progression as documented on the participant follow-up status form, Initiation of subsequent anticancer therapy.|Approximately up to 1 year|Safety Population. Analysis set included only participants whose best overall response was not disease progression.|||Months||Full Range|Median
1467250|NCT00725764|Secondary|Duration of Overall Survival|Overall survival was defined as the duration from the date of the first dose to the date of death. The start of a confounding anticancer therapy was treated as a censoring event. Every effort made to follow participant’s until death. Time to death was censored at the date of the latest participant contact or at the analysis cutoff date, if earlier. Kaplan-Meier method was used to estimate the overall survival distribution.|Approximately up to 1 year|Safety Population.|||Months||Full Range|Median
1467251|NCT00725764|Secondary|Duration of Progression-free Survival|Progression-free survival was defined as the duration from the date of first dose to the date of disease progression or date of death without documented progression or date of study termination + 1. The start of confounding anticancer therapy was not treated as a censoring event. Time to progression or death was censored at the study termination date or at the analysis cutoff date, if earlier.|Approximately up to 1 year|Safety Population.|||Months||Full Range|Median
1467252|NCT00725764|Primary|Number of Participants With Abnormalities in Urinalysis|Urinalysis parameters like appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood were performed. Number of participants with abnormalities are reported. In case of no abnormalities observed then it is reported as zero.|Week 5 [Day 29]|Safety population.|||Participants|||Count of Participants
1467264|NCT00725725|Secondary|Change in Anxiety Sensitivity Index (ASI) Score|The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT.|||ASI Score||Standard Deviation|Mean
1467253|NCT00725764|Primary|Number of Participants With Abnormalities of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 in Laboratory Parameters (Clinical Chemistry and Hematology)|The National Cancer Institute -CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on the following general guideline: Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE and Grade 5: Death related to AE. Number of participants with abnormalities of CTCAE grade 3 in clinical chemistry parameters: alanine aminotransferase (ALT), γ-glutamyl transferase (GGT), phosphate, low sodium and hematology parameters: Leukocyte and Lymphocytes were presented.|Up to 20 months|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1467254|NCT00725764|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.|Up to 20 months|Safety Population.|||Participants|||Count of Participants
1467255|NCT00725764|Primary|Percentage of Participants With Objective Response Rate (ORR)|ORR was defined as the proportion of participants achieving best overall response of confirmed CR or PR divided by the total number of participants who received treatment. Per RECIST v1.0 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; Partial Response PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR. Participants were evaluated for tumor response per RECIST. Percentage of participants with ORR were reported.|Approximately up to 1 year|Safety Population.|||Percentage of participants||95% Confidence Interval|Number
1467256|NCT00725764|Primary|Number of Participants Achieving Best Overall Response|Best overall response was assessed by the investigator per response evaluation criteria in solid tumors (RECIST). Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Tumor size was recorded at Baseline, and tumor response were recorded approximately every 8 weeks. Tumor response were classified by the investigator using RECIST criteria participant’s best response whether observed in the study treatment period or the treatment extension period was considered. The best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Number of participants who achieved best overall response were recorded.|Approximately up to 1 year|safety population comprised of all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.|||Participants|||Count of Participants
1467257|NCT00725751|Secondary|Number of Participants Who Received Antiviral Treatment Who Were Also on Substitution Therapy|This measure was the number of all of the participants who received antiviral treatment who also received substitution therapy.|Day 1|Participants who received at least one dose of antiviral treatment.|||participants|||Number
1467258|NCT00725751|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as a hepatitis C virus (HCV) ribonucleic acid (RNA) value below the limit of detection by polymerase chain reaction (PCR) analysis. For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 weeks after the end of treatment (i.e. 48 or 72 weeks depending on genotype)|All treated participants.|||participants|||Number
1467259|NCT00725751|Primary|Number of Participants Who Completed Treatment With PegIFN-2b/Ribavirin|For participants with Genotype 1 or 4 completion of treatment was at Week 48; for participants with Genotype 2, 3, or 1 with low viral load or rapid virologic response, completion of therapy was at Week 24.|24 to 48 weeks|Participants who received at least one dose of PegIFN-2b/ribavirin|||participants|||Number
1467260|NCT00725725|Secondary|Number of Participants Discontinuing Study Therapy Due to AEs|The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 2 weeks|All treated participants are included in the safety analysis.|||Participants|||Number
1467261|NCT00725725|Secondary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 59 days|All treated participants are included in the safety analysis.|||Participants|||Number
1467262|NCT00725725|Secondary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score|"The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 (very poor) to 5 (very good), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life)."|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT.|||Q-LES-Q Score||Standard Deviation|Mean
1467263|NCT00725725|Secondary|Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score|The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT.|||MADRS score||Standard Deviation|Mean
1467265|NCT00725725|Secondary|Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score|The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT.|||SIGH-A Score||Standard Deviation|Mean
1467266|NCT00725725|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score|The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill).|Screening and Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT.|||CGI-S Score||Standard Deviation|Mean
1467267|NCT00725725|Secondary|SCID-I/P With Psy Screen Score at EOT|The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Day 36|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT.|||Participants|||Number
1467268|NCT00725725|Secondary|Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening|The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with [w] or without [w/o] AGP) as being current (full criteria for the disorder met), in full remission (IFR) [there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder], or in partial remission (IPR) [full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.|Screening|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening.|||Participants|||Number
1467269|NCT00725725|Secondary|Change in PDSS Score From Baseline to Follow-Up|The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Follow-Up (Day 59)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up.|||PDSS Score||Standard Deviation|Mean
1467270|NCT00725725|Secondary|Change in PDSS Score From Baseline to Visit 4|The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Visit 4 (Day 22)|The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4.|||PDSS Score||Standard Deviation|Mean
1467271|NCT00725725|Primary|Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)|The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).|Screening and Day 36|The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT.|||PDSS Score||Standard Deviation|Mean
1467272|NCT00725712|Secondary|Median Duration of Overall Survival (OS)of GSK1363089|Duration of OS is defined as (Date of Death [due to any cause]) minus Date of first dose. For the participants who were alive at the time of data cut-off, duration of overall survival was censored at the date of last contact. The upper value of the full range was censored observation.|At every 8 Weeks upto 31 months|Evaluable population|||months||Full Range|Median
1467273|NCT00725712|Secondary|Disease Stabilization Rate of GSK 1363089|It is defined as the number of participants achieving best overall response of confirmed CR or PR or stable disease (SD). It was assessed using RECIST criteria 1.0. The CR for target lesions was defined as disappearance of all TLs and the NTLs. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference, the smallest sum LD since the treatment started.|At every 8 Weeks upto 31 months|Safety population|||percentage of participants||95% Confidence Interval|Number
1467274|NCT00725712|Secondary|Duration of Stable Disease of GSK1363089|Duration of stable disease, was defined as the time between the date of first dose and death or disease progression, in participants whose best overall response was not progressive disease|At every 8 Weeks upto 31 months|Evaluable population. Only those participants available at the specified time-points were analyzed.|||months||95% Confidence Interval|Median
1467285|NCT00725712|Primary|Change From Baseline in Vital Signs-Systolic and Diastolic Blood Pressure|Participants systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in mm of mercury (mmHg). These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. The data for minimum (min) and maximum (max) post-baseline has been reported. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
1467275|NCT00725712|Secondary|Median Progression Free Survival (PFS) of GSK1363089|Duration of PFS in months is defined as (Date of Disease Progression/Death - Date of First Dose + 1)/30.44. For participants who did not reach an event (disease progression or death) at the time of data cut-off, duration of PFS is censored at date of last available tumor assessment that is not 'Unable to Evaluate'. For participants who did not have any post-baseline tumor assessments, PFS was censored at Day 1. For any participants who received subsequent anti-cancer therapy, PFS will be right censored at the date of last adequate tumor assessment on or prior to the date of anti-cancer therapy initiation. For any participants who died or progressed after an extended lost-to-follow-up time (greater than 17 weeks), PFS was censored at the date of last adequate assessment prior to extended lost-to follow-up.|At every 8 Weeks upto 31 months|Safety population|||months||95% Confidence Interval|Median
1467276|NCT00725712|Primary|Number of Participants Who Required Concomitant Medications|The number of participants who received concomitant medication during the study were reported. The data has been reported for the participants who have received subsequent chemotherapy, subsequent radiation therapy or other therapy.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population.|||Participants|||Count of Participants
1467277|NCT00725712|Primary|Number of Participants With Shift From Baseline by Grade for Hematology Parameters|The worst overall grading by CTCAE version 3.0, was used to report the shift from baseline for hematology parameters namely hemoglobin, platelets and lymphocytes. The grades were namely G0, G1, G2, G3 and G4. The data for shifts from G2 to G3 and G0 to G4, mainly the shifts to higher grades G3 and G4 have been reported.|Baseline (pre-dose) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
1467278|NCT00725712|Primary|Number of Participants With Grade Shift for Urinalysis Parameters|The urinalysis parameters by worst case overall CTCAE grade shift post Baseline for each parameter were mentioned as per the CTCAE grading for version 3.0 and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for abnormal values for bilirubin, ketones, nitrites, occult blood, pH, protein, specific gravity, and urobilinogen.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified timepoints were reported.|||participants|||Number
1467279|NCT00725712|Primary|Number of Participants With Shift From Baseline by High/Low Flag for Hematology Paramaters|The hematology parameters worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. CTCAE grading for version 3.0 was used and done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for basophils, eosinophils, erythrocytes, hematocrit, and monocytes were analyzed. Only the abnormal values were reported where normal to high and normal to low changes were reported. Worst Overall was defined as highest post baseline CTCAE grade before 30 day follow up.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||participants|||Number
1467280|NCT00725712|Primary|Number of Participants With Shift From Baseline in Serum Chemistry- Graded|The worst overall common terminology criteria for adverse events version 3.0 (CTCAE) grade (G) shift post baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading is done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases, aspartate aminotransferases, Albumin, alkaline phosphatase, calcium, sodium, potassium, glucose, amylase, amylase, bilirubin, creatinine, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. Worst Overall defined as worst post baseline out of normal range flag in the order of (high, low, normal) before 30 day follow up. Data for G3 and G4 is reported.|From Day 1 to up to 30-day follow-up visit (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed .|||Participants|||Count of Participants
1467281|NCT00725712|Primary|Number of Participants With Shift From Baseline in by High/Low Flag for Serum Chemistry- Ungraded|The data for serum chemistry parameters like albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), amylase, aspartate amino transferase (AST), calcium, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, blood urea nitrogen (BUN), chloride, free thyroxine, free triiodothyronine, lipase, phosphorous, potassium, sodium, total bilirubin, lactate dehydrogenase, total protein. The abnormal values have been reported wherein data for normal to low and normal to high has been reported.|From Day 1 and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points we re analyzed.|||participants|||Number
1467282|NCT00725712|Primary|Change From Baseline in Respiratory Rate (RR)|The RR for the participant’s, were collected after the participant sat quietly for at least five minutes. Baseline evaluations should be performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1 . The RR was measured in breaths per minute. Min and max post-baseline values are reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time-points were analyzed.|||breaths per minute||Standard Deviation|Mean
1467283|NCT00725712|Primary|Change From Baseline in Temperature|The body temperature for the participants was assessed. These were collected after the participant sat quietly for at least five minutes. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline is defined as the last non-missing record on or before first dose.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||degree celsius||Standard Deviation|Mean
1467284|NCT00725712|Primary|Change From Baseline in Vital Signs-Pulse Rate|The pulse rate or heart rate (HR) for the participant’s, were collected after the participant sat quietly for at least five minutes. Baseline evaluations were performed within 72 hours before the first dose. If performed within 24 hours of the first dose, baseline evaluations may serve as the pre-dose Day 1 visit evaluations. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline was defined as pre-dose, Day 1. The HR was measured in beats per minute (bpm). The min and max values have been reported.|Baseline (pre-dose, Day 1) and before 30-day follow- up (up to 2 years)|Safety population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
1467286|NCT00725712|Primary|Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered SAEs if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.|Up to 31 months|Safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug.|||participants|||Number
1467287|NCT00725712|Primary|Number of Participants With Objective Response Rate (ORR), of GSK1363089, Per- Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0|ORR is defined as the percentage of participants achieving best overall response of confirmed complete response (CR) or partial response (PR). Tumor response for participants with measurable lesions was assessed routinely (after 8 weeks of treatment and approximately every 8 weeks thereafter) using RECIST (version 1.0) criteria. The CR for target lesions was defined as disappearance of all target lesions (TLs) and the non-target lesions (NTLs). PR defined as at least 30% decrease in sum of the longest diameter (LD) of TLs, taking as reference baseline sum LD. The safety population included all participants who passed the screening criteria, enrolled in the study, and received at least 1 dose of study drug. Progressive disease will be used as PD.|At every 8 Weeks upto 31 months|Evaluable population included participants from safety population who had received atleast 75% of protocol mandated doses at treatment period, had BL and post BL tumor assessment, with no extended lost to followup (17 wks or more) or who had received atleast 75% of protocol mandated doses at treatment period and discontinued study drug due to PD.|||participants|||Number
1467288|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.|||Score on a scale||Standard Deviation|Mean
1467289|NCT00725621|Secondary|Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)|Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|24 months maximum|Remicade-naive participants with available data.|||Score on a scale||Standard Deviation|Mean
1467290|NCT00725621|Primary|Median Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Full Range|Median
1467291|NCT00725621|Primary|Mean Remicade Dose Per Participant||Maximum of 102 weeks|Remicade-naive participants who were exposed to Remicade during the observational study.|||mg/kg||Standard Deviation|Mean
1467292|NCT00725621|Primary|Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||mg/kg||Full Range|Median
1467293|NCT00725621|Secondary|Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|Some participants had more than one previous treatment with a DMARD.|24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.|||Participants|||Number
1467294|NCT00725621|Secondary|Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy||24 months maximum|Remicade-naive participants who were exposed to Remicade during the observational study.|||Years||Standard Deviation|Mean
1467295|NCT00725621|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 102 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
1467296|NCT00725621|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Full Range|Median
1467297|NCT00725621|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy|The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.|Maximum of 16 weeks|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Standard Deviation|Mean
1467298|NCT00725608|Secondary|Dispensing of Suboxone (Buprenorphine Plus Naloxone)|Another of the secondary objectives was to evaluate the effect of the switch to Suboxone (buprenorphine plus naloxone) on medication dispensing measured by frequency of visits to the treating physician or pharmacy to receive the medication (daily, biweekly, once weekly, monthly, other)|month 6, month 12|All participants with eligible datasets were included in the final analysis|||Participants|||Number
1467304|NCT00725543|Primary|Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy||Maximum of 24 months.|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
1467305|NCT00725543|Primary|Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Full Range|Median
1467306|NCT00725543|Primary|Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy||Maximum of 24 months|Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.|||Days||Standard Deviation|Mean
1467307|NCT00725530|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|7 days|All enrolled participants.|||Participants|||Number
1467308|NCT00725504|Primary|Present Pain Intensity|Present pain intensity was measured using the visual analog scale (VAS). This is scored between 0 (no pain) to 10 (worst possible pain).|Patients completed the VAS of present pain intensity at each infusion level. Each infusion level took approximately one hour, and the assessment was done at the end of the hour (approximately 3 hours total).||||Score||Standard Error|Mean
1467309|NCT00725491|Primary|The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.|The hCG criterion is met the first day that 3 follicles >= 17 mm are observed.|At completion of ovarian stimulation; maximally after 18 days of recFSH administration.|The number of participants for this analysis included only those participants in the intent-to-treat (ITT) group who received hCG and for whom data was available.|||international units (IU)||Standard Deviation|Mean
1467310|NCT00725452|Secondary|Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab|BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.|Baseline and Infusion 9|Infliximab-naive participants who received Infliximab during the study.|||Percent of BSA involved with psoriasis||Standard Deviation|Mean
1467311|NCT00725452|Secondary|Median Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.|||mg/kg||Full Range|Median
1467312|NCT00725452|Secondary|Mean Dose of Infliximab||Maximum 2 years|All participants who received at least 1 Infliximab infusion during the observational phase.|||milligrams/kilograms (mg/kg)||Standard Deviation|Mean
1467313|NCT00725452|Secondary|Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.|||Days||Full Range|Mean
1467314|NCT00725452|Secondary|Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy||Maximum 2 years|Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.|||Days||Standard Deviation|Mean
1467315|NCT00725452|Primary|Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab|"The types of therapies were assessed according to the following criteria:~Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days).~Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks).~Episodic Therapy: given out of time frame (> 12 weeks)."|Maximum 2 years|Infliximab-naive participants who received Infliximab during the study.|||Therapies|||Number
1467316|NCT00725361|Secondary|Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline.|Range is 0-3 with 0 meaning the least amount of disability and 3 the greatest of disability.|24 weeks||||units on a scale||Standard Deviation|Mean
1467317|NCT00725361|Secondary|Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||Participants|||Count of Participants
1467318|NCT00725361|Secondary|Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12.||12 weeks|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||Participants|||Count of Participants
1467319|NCT00725361|Secondary|New DU 4 Weeks Prior to Week 12|The number of new DU that have developed in the preceding 4 weeks assessed at week 12 from baseline.|4 weeks prior to week 12|At 12 weeks only 1 patient had withdrawn from the study and 19 remained in the study.|||new digital ulcers||Standard Deviation|Mean
1467320|NCT00725361|Primary|New Digital Ulcers (DU) 4 Weeks Prior to Week 24|The number of new digital ulcers (DU) that have developed in the preceding 4 weeks assessed at week 24 from baseline.|4 weeks prior to week 24||||new digital ulcers||Standard Deviation|Mean
1467321|NCT00725322|Secondary|NRS Score Three Weeks After Injection|The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.|Three weeks after injection|Although 27 participants completed the study, 3 participants were excluded from analysis of the NRS score because they had missing data.|||Units on a scale||Standard Deviation|Mean
1467322|NCT00725322|Primary|Time Until Analgesic Failure|Participants made daily NRS reports via Palm Pilot, and “failure” was defined as (Pre-injection baseline NRS) – (Mean NRS for any 3 preceding days) ≤ 0; or 9 months|Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline||||Days||Standard Deviation|Mean
1467323|NCT00725296|Primary|Median Dose of All Infusions Per Participant|The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.|||mg/kg||Full Range|Median
1467324|NCT00725296|Primary|Average Overall Dose of All Infusions Per Participant|The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.|Up to 24 Months|152 out of the 159 Infliximab-naive participants were treated in the active phase.|||mg/kg||Standard Deviation|Mean
1467325|NCT00725296|Primary|Median Dose During Induction Therapy and Subsequent Maintenance Therapy|The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||mg/kg||Full Range|Median
1467326|NCT00725296|Primary|Average Dose During Induction Therapy and Subsequent Maintenance Therapy|The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).|Up to 24 Months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||mg/kg||Standard Deviation|Mean
1467327|NCT00725296|Primary|Median Time Interval Between Infusions During Maintenance Therapy|The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||days||Full Range|Median
1467328|NCT00725296|Primary|Mean Time Interval Between Infusions During Maintenance Therapy|The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.|Up to 24 months|"N= number of Infliximab-naive participants that received induction & maintenance therapy.~Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions)."|||days||Standard Deviation|Mean
1467329|NCT00725283|Secondary|Number of Patients With Serious Adverse Events Related to Study Treatment|Serious adverse events (SAEs) assessed include medical occurrences related to treatment administration that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the CRF, but not as an SAE.|During the whole study duration (From Day 0 up to the concluding visit, at Month 49)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1467330|NCT00725283|Secondary|Number of Patients With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include any medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure, therefore, it did not need to be reported as an SAE. Death due to progressive disease was recorded on a specific form in the Clinical Report Form (CRF), but not as an SAE.|During the whole study duration (From Day 0 up to the concluding visit, at Month 49)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1467331|NCT00725283|Secondary|Number of Patients With Any Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-administration period|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1467332|NCT00725283|Primary|Number of Patients With Anti-WT1 Antibody Response|"Treatment response was defined as:~For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/ML; For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration."|At Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||Participants|||Count of Participants
1467333|NCT00725283|Primary|Concentrations for Anti-WT1 Antibodies|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).|At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||EU/mL||95% Confidence Interval|Geometric Mean
1467334|NCT00725283|Primary|Seropositivity Rates for Anti-Wilms Tumor Antigen 1 (WT1) Antibodies|Seropostivity rate was defined as the number of patients with anti-WT1 antibody concentration greater than or equal to (≥) the cut-off value of 9 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).|At Baseline [Week 0], at Cycle 1 visits [Weeks 5, 9, 13], at Cycle 2 visits [Weeks 15, 21, 32], at Cycle 3 visits [Weeks 40, 54], at Cycle 4 visits [Months 15, 18, 21, 24, 30 and 49 (concluding visit)] and at Follow-up Visits [Months 52, 55, 58, 61]|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses and for whom assay results were available at the considered timepoints.|||Participants|||Count of Participants
1467335|NCT00725283|Primary|Number of Patients With Severe Toxicities|"Severe toxicities (as classified according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0) during the study treatment period defined as a study product-related or possibly study product-related:~Grade 4 toxicity (exception: Grade 4 fatigue – including lethargy, asthenia, and malaise – had to have a duration of at least 48 hours to be taken into account).~Grade 3 toxicity lasting for at least 48 hours (exceptions: myalgia, arthralgia, headache, and fever, regardless of duration).~An allergic reaction/hypersensitivity Grade 2 toxicity (i.e., rash, flushing, urticaria, and dyspnea). Drug fever was not part of this definition.~Decrease in renal function, with a calculated creatinine clearance < 40 mL/min.~Grade 2 cardiac ischemia/infarction (i.e., asymptomatic and testing suggesting ischemia; stable angina)."|During the study treatment period (From Day 0 to Month 48)|This analysis was performed on the Total treated population, which included all patients who had started treatment and received at least one dose of the study product, which were included in the overall safety analyses.|||Participants|||Count of Participants
1467336|NCT00725270|Primary|Change in Mood Symptoms|Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression.|Baseline and Day 9||||units on a scale||Standard Deviation|Mean
1467337|NCT00725270|Primary|Change in Positive Psychotic Symptoms Over the Course of Treatment|Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms|8 days||||units on a scale||Standard Deviation|Mean
1467338|NCT00725205|Secondary|Number Of Participants Self-Administering Pegylated Interferon Alfa-2b|Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.|Up to 48 Weeks|All Participants enrolled.|||Participants|||Number
1467339|NCT00725205|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.|24 Weeks following completion of 24 or 48 weeks of therapy|Full Analyses Set: All enrolled participants who received any dose of any medication (Peginterferon or Ribavirin) and had a known viral genotype. Of the 294 enrolled participants, 2 were not treated.|||Participants|||Number
1467340|NCT00725205|Primary|Number of Participants Who Are Triple-80 Compliant|Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.|24 or 48 Weeks|"All enrolled participants who received any dose of any medication, had a known viral genotype, and did not discontinue from the study with the status being “treatment~failure”. Of the 294 enrolled participants, 253 participants started treatment and continued treatment beyond Week 12."|||Participants|||Number
1467341|NCT00725153|Primary|Front Surface Lens Deposits|Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).|10 hours|All enrolled participants.|||Participants|||Number
1467342|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)|Participant productivity was described as the number of days a participant missed work due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1467513|NCT00724815|Secondary|Photophobia Free at Two Hours|Subjects who were photophobia free and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1467343|NCT00725101|Secondary|Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)|Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1467344|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)|Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1467345|NCT00725101|Secondary|Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)|Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1467346|NCT00725101|Secondary|Number of Days of Partial Care for Fibromyalgia (FM) Participants|Partial (day or night) care included day care, day nursing home, and partial hospitalization.|Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit.|||days||Standard Deviation|Mean
1467347|NCT00725101|Secondary|Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing ER visit values.|||ER visits||Standard Deviation|Mean
1467348|NCT00725101|Secondary|Number of Outpatient Visits Due to Fibromyalgia (FM)||Baseline through 12 months|The analysis population included enrolled participants who had at least 1 follow-up visit. The number of participants actually used in analyses were less than 1700 because some had missing outpatient visit values.|||outpatient visits||Standard Deviation|Mean
1467349|NCT00725101|Secondary|Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months|The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing SDS scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1467350|NCT00725101|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months|FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.|Baseline, 12 months|The analysis population included enrolled participants who had non-missing FIQ scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1467351|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months|BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-S scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1467352|NCT00725101|Secondary|Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months|Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, 12 months|The analysis population included participants who had non-missing BPI-I scores at Baseline and 12 months.|||units on a scale||Standard Deviation|Mean
1467353|NCT00725101|Secondary|Hazard Ratios for Factors Associated With Discontinued Opioid Use|Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.|Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.|||hazard ratio|||Number
1467354|NCT00725101|Secondary|Percentage of Participants Who Discontinued Opioids||Baseline through 12 months|The analysis population included participants who were using opioids at Baseline.|||percentage of participants|||Number
1467355|NCT00725101|Secondary|Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study|Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.|Baseline through 12 months|The analysis population included participants who reported discontinuing medication at least once during the 12-month period post-baseline.|||participants|||Number
1467356|NCT00725101|Primary|Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use|Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity [not at all severe, severe for several days, severe for more than half the days, severe nearly every day]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.|||odds ratio||95% Confidence Interval|Number
1467357|NCT00725101|Primary|Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication|Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.|Baseline through 12 months|The analysis population included enrolled participants who had non-missing covariates used in logistic regression.|||odds ratio||95% Confidence Interval|Number
1467358|NCT00725101|Primary|Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months||Baseline through 12 months|The analysis population included enrolled participants who took part in all follow-up interviews.|||medications||Standard Deviation|Mean
1467359|NCT00725075|Secondary|Change From Baseline in Extrapyramidal Symptoms Rating Scale Score at Week 12|The abbreviated Extrapyramidal Symptoms Rating Scale (ESRS-A) was a sum of the severity rating of a 24-item instrument assessing four types of movement disorders: parkinsonism, dystonia, dyskinesia, and akathisia. Each item was rated on a 7-point scale, from 0=absent to 6=severe. Higher scores indicated more impairment. A negative change from baseline indicated an improvement.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy.|||Score on a Scale||Standard Deviation|Mean
1467360|NCT00725075|Secondary|Change From Baseline in Composite Memory Score at Week 12|Composite memory was a composite of verbal memory and visual memory and was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467361|NCT00725075|Secondary|Change From Baseline in Executive Functioning Score at Week 12|Executive functioning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Shifting Attention Test. The participant matched geometric shapes either by shape or color. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received ≥1 dose of study therapy and completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467362|NCT00725075|Secondary|Change From Baseline in Sustained Attention Score at Week 12|Sustained attention was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was asked to identify a target shape/color when presented with a battery of different geometric shapes/colors. Only Parts 2 to 4 of the 4 Part Continuous Performance Test contributed towards the sustained attention score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467363|NCT00725075|Secondary|Change From Baseline in Working Memory Score at Week 12|Working memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-4-Part Continuous Performance Test. The participant was presented with targets and remembered target presentation sequencing in order to respond to the directions. Only Part 4 of the 4 Part Continuous Performance Test contributed towards the working memory score. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467364|NCT00725075|Secondary|Change From Baseline in Speed of Complex Information Processing Score at Week 12|Speed of complex information processing was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery-Symbol-digit Coding Test. The participant linked numbers to digits. The test consisted of serial presentations of screens, each containing a bank of 8 symbols above and 8 empty boxes below. The participant typed the number that corresponded to the symbol highlighted. The raw score was the processing time in milliseconds. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467365|NCT00725075|Secondary|Change From Baseline in Visual Memory Score at Week 12|Visual memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 geometric figures within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Sore on a Scale||Standard Deviation|Mean
1467366|NCT00725075|Secondary|Change From Baseline in Verbal Memory Score at Week 12|Verbal memory was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant remembered 15 words within a field of 15 distractors immediately and after a twenty minute delay. The raw score was the sum of correct responses. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467367|NCT00725075|Secondary|Change From Baseline in Non-Verbal Reasoning Score at Week 12|Non-verbal reasoning was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant solved 15 visual analogies composed of geometric 2x2, 3x3, or 4x4 puzzles by choosing the most appropriate geometric figure that solved the matrix. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467368|NCT00725075|Secondary|Change From Baseline in Perception of Emotions Score at Week 12|Perception of emotion was measured by computer using the CNS-Vital Signs Neurocognitive Test Battery. The participant identified different emotional states (happy, sad, angry, and calm [neutral]) presented in pictures of faces by choosing the appropriate word for the emotion. The raw score was the sum of correct responses minus errors. The standard scores were normalized from raw scores and presented an age-matched score relative to a normative comparison database. Higher scores were better.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467369|NCT00725075|Secondary|Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) at Week 12|CDSS was a 9-item clinician-rated instrument used to evaluate depression in participants who have schizophrenia. For each item, symptom severity was rated on a 4-point scale, from 0=absent to 3=severe, with a total scoring range of 0 to 27. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467370|NCT00725075|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Schizophrenia at Week 12|PANSS was a 30-item clinician-rated instrument used for assessing the positive, negative, and general psychopathology symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme, with a total scoring range of 30 to 210. Higher scores indicated more impairment. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467371|NCT00725075|Primary|Change From Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS 1-22 Composite Score) at Week 12|SANS was a 25-item clinician-rated instrument for assessing the negative symptoms of schizophrenia. SANS 1-22 Composite Score consisted of the SANS 25 scale minus the last 3 questions (attention items). The remaining non-attention items (affective flattening, alogia, avolition-apathy, and anhedonia-asociality) comprised the SANS 1-22 Composite Score. For each item, symptom severity was rated on a 6-point scale, from 0=absent to 5=severe. The SANS 1-22 Composite Score had a total scoring range of 0 to 110. Higher scores indicated more impairment. The SANS 1-22 Composite Score was reported using data from the adjusted site rater. A negative change from baseline indicated an improvement in symptoms.|Baseline and Week 12|All randomized participants who received either MK-8435 (Org 25935) or placebo and who completed at least 8 weeks of treatment.|||Score on a Scale||Standard Deviation|Mean
1467372|NCT00725049|Secondary|Cost Analysis||3 years||2018-12-31|12/2018||||
1467373|NCT00725049|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.|3 years|Number of participants used in analysis selected as per protocol|||participants|Dental implants||Number
1467374|NCT00725010|Primary|Number of Participants Who Discontinued Due to Toxicity||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase||||Participants|||Number
1467375|NCT00725010|Primary|Safety: Number of Adverse Events in the Indicated Categories||Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase||||Adverse Events|||Number
1467376|NCT00724984|Primary|Phase II: Overall Response Rate (CR+PR)||From first response assessment (day 22 to 28 of Cycle 2) to last response assessment on day 22-28 in even-numbered cycles||||Percentage of Participants||95% Confidence Interval|Number
1467377|NCT00724984|Primary|Phase I (Dose Escalation Phase): MTD and DLTs of PCI-24781 Administered Twice Daily (BID) Measure: Disease Response|Number of patients experienced DLT in each cohort|From the Date of PCI-24781 first administration to Cycle 2 Day 1||||participants|||Number
1467378|NCT00724958|Primary|Total Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy.|||mg/kg||Standard Deviation|Mean
1467379|NCT00724958|Primary|Median Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||mg/kg||Full Range|Median
1467380|NCT00724958|Primary|Average Dose of Infliximab Per Participant Within the Observation Period|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||mg/kg||Standard Deviation|Mean
1467381|NCT00724958|Secondary|Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.|HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease).|5 years|207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)|||Score on a scale||Standard Deviation|Mean
1467382|NCT00724958|Primary|Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||Days||Full Range|Median
1467383|NCT00724958|Primary|Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)|Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).|up to 2 years|n = number of infliximab-naive participants|||Days||Standard Deviation|Mean
1467384|NCT00724945|Primary|Subject Vision|"Subjects responded to How would you rate the overall quality of vision with these study contact lenses using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent."|after 1 week wear||||Scores on a scale||Standard Error|Least Squares Mean
1467385|NCT00724945|Primary|Near Visual Acuity|This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal.|after 1 week wear||||logMAR units||Standard Error|Least Squares Mean
1467386|NCT00724945|Primary|Distance Visual Acuity|This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values >0.00 indicate vision poorer than ideal and values<0.0 indicate vision greater than ideal|after 1 week of wear|Analysis includes participants who completed the study per protocol.|||logMAR units||Standard Error|Least Squares Mean
1467387|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Non-serious Adverse Events (AEs) and Post-treatment Non-serious AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration.|From signing of informed consent to end of trial (7 days after surgery)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1467388|NCT00724932|Secondary|Number of Participants Who Experienced Pre-treatment Serious Adverse Events (SAEs) and Post-treatment SAEs|"An SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.~Participants were monitored for occurrence SAEs for up to 7 days after last dose IMP. Pre-treatment refers to the period from signing of the informed consent up to start of IMP administration. Post-treatment refers to the period from start of IMP administration to 7 days after IMP administration."|From signing of informed consent to end of trial (7 days after surgery)|The All-Subjects-Treated (AST) Population consisted of all randomized participants who received IMP.|||participants|||Number
1467389|NCT00724932|Other Pre-specified|Time From PACU Admit to Actual PACU Discharge|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From PACU admit to actual PACU discharge (up to ~4.3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467390|NCT00724932|Other Pre-specified|Time From PACU Admit to PACU Discharge Ready|The time of PACU admit was defined as the actual time the participant was admitted to the PACU. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From PACU admit to PACU discharge ready (up to ~25 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467391|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to Actual PACU Discharge|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From actual Operating Room discharge to actual PACU discharge (up to ~4.4 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467392|NCT00724932|Other Pre-specified|Time From Actual Operating Room Discharge to PACU Discharge Ready|The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From actual Operating Room discharge to PACU discharge ready (up to ~30 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467393|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual PACU Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge was defined as the actual time the participant was discharged from the PACU.|From Operating Room discharge ready to actual PACU discharge (up to ~4.5 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467427|NCT00724893|Secondary|Number of Participants Achieving RVR by Gender (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1467394|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Post Anesthetic Care Unit (PACU) Discharge Ready|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of PACU discharge ready was defined as the time at which the participant had a Modified Aldrete Score >=9. The Modified Aldrete Score was to be assessed at PACU arrival, at 5, 15, 30, 45, 60 minutes after PACU arrival and every 15 minutes thereafter (if applicable) until the participant was ready to be discharged from the PACU. The Modified Aldrete Postoperative Recovery Score (range = 0-10) is calculated based on scores of 0 to 2 each for Activity, Respiration, Circulation, Consciousness and Oxygen Saturation, with a higher score indicating increased postoperative recovery.|From Operating Room discharge ready to PACU discharge ready (up to ~33 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467395|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Actual Operating Room Discharge|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From tracheal extubation to actual OR discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467396|NCT00724932|Other Pre-specified|Time From Tracheal Extubation to Operating Room Discharge Ready|The time of tracheal extubation was defined as the actual time at which the participant was extubated. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From tracheal extubation to Operating Room discharge ready (up to ~1 minute)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467397|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Actual Operating Room Discharge|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge was defined as the actual time at which the participant was discharged from the Operating Room.|From start of IMP administration to actual Operating Room discharge (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467398|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Operating Room Discharge Ready|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place.|From start of IMP administration to Operating Room discharge ready (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467399|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to Tracheal Extubation|The time of IMP administration was defined as the actual time at which IMP administration was started. The time of tracheal extubation was defined as the actual time at which the participant was extubated.|From start of IMP administration to tracheal extubation (up to ~21 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467400|NCT00724932|Other Pre-specified|Time From Start of IMP Administration to T4/T1 Ratio of <=0.60, >0.60 - <=0.70, >0.70 - <=0.80, >0.80 - <0.90 and >=0.90|The time of IMP administration was defined as the actual time at which IMP administration was started.|From start of IMP administration to recovery of the T4/T1 ratio to the designated value (ranging from ~1 minute to ~10 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Data not collected. In Protocol Amendment 2, this outcome measure was removed.||||||
1467401|NCT00724932|Other Pre-specified|Time From Operating Room Discharge Ready to Actual Operating Room Discharge|The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of >=0.9 and the participant's wound dressing was in place. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room discharge ready to actual Operating Room discharge (up to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467402|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Actual Operating Room Discharge|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge was defined as the actual time the participant was discharged from the Operating Room.|From Operating Room admission to actual Operating Room discharge (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467403|NCT00724932|Other Pre-specified|Time From Operating Room Admission to Operating Room Discharge Ready|The time of Operating Room admission was defined as the time at which the participant was physically placed into the Operating Room. The time of Operating Room discharge ready was defined as time at which the participant had T4/T1 ratio of ≥0.9 and the participant's wound dressing was in place.|From Operating Room admission to Operating Room discharge ready (up to ~3 hours)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||minutes||Standard Deviation|Mean
1467404|NCT00724932|Other Pre-specified|Number of Female Participants or Partners of Male Participants Who Became Pregnant During Study|Thirty days after administration of IMP, female participants of childbearing potential were asked whether they became pregnant during the trial and male participants were asked whether their partner (if of childbearing potential) became pregnant during the trial.|Up to 30 days after IMP administration|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1467405|NCT00724932|Other Pre-specified|Monitoring of Clinical Signs of Recovery According to Routine Anesthetic Procedures at the Trial Sites|The monitoring of clinical signs of recovery was to be conducted based on the routine anesthetic procedures at each site.|Up to PACU discharge (up to ~4.5 hours)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1467406|NCT00724932|Other Pre-specified|Number of Participants With Events Due to a Possible Interaction of Sugammadex With Endogenous Compounds or With Exogenous Compounds Other Than Rocuronium|Any evidence of events due to a possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium, was to be recorded.|Up to 7 days after IMP administration|The AST Population consisted of all randomized participants who received sugammadex. Participants who received neostigmine were excluded from this analysis.|||participants|||Number
1467407|NCT00724932|Other Pre-specified|Number of Participants With Clinical Evidence of Reoccurrence of Neuromuscular Blockade or Residual Neuromuscular Blockade (Routine Oxygen Saturation by Pulse Oximetry and Breath Frequency Measurement)|Clinical evidence of reoccurrence of NMB or residual NMB was assessed by oxygen saturation (by pulse oximetry) and breath frequency measurements as per routine practice after anesthesia and neuromuscular monitoring.|Up to 24 hours after IMP administration|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1467408|NCT00724932|Other Pre-specified|Number of Participants With Reoccurrence of Neuromuscular Blockade Based on the Train-of-Four- (TOF-) Watch® SX Recording (i.e. a Decline in T4/T1 Ratio From >=0.9 to <0.8 in at Least Three Consecutive TOF Values)|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the 1st and 4th twitches, respectively, after TOF stimulation. The T4/T1 Ratio is expressed as a decimal of up to 1.0. A higher ratio indicates greater recovery from NMB. A decline in the T4/T1 ratio from >=0.9 (indicating a recovery from NMB) to <0.8 for at least three consecutive TOF values was considered to be a reoccurrence of NMB.|Up to 30 minutes after IMP administration|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement.|||participants|||Number
1467409|NCT00724932|Other Pre-specified|Number of Participants With Train-of-Four- (TOF-) Watch® SX and Arm Board Related Adverse Events|Events were to be collected for the entire period of neuromuscular transmission monitoring and were defined as an occurrence that resulted or could have resulted in: death; a serious deterioration in the state of health of a user; an occurrence which might, if it recurred, lead to death or serious deterioration in health; inaccuracy as well as any inadequacy in the labeling or instructions which could cause misuse or incorrect maintenance or adjustment which might lead to a death or serious deterioration in health; an examination of the medical device or the information supplied with the medical device indicated some factor with the potential for an incident involving death or serious deterioration in health; malfunction or deterioration in characteristics and/or performance of a medical device, which might lead to death, or serious deterioration in health; technical/medical recalls involving risk of death or serious deterioration in the state of health of the user.|From induction of anesthesia to recovery from NMB (up to ~3 hours)|The AST Population consisted of all randomized participants who received IMP.|||participants|||Number
1467410|NCT00724932|Other Pre-specified|Number of Participants Who Had Physical Examinations|Physical examinations were to be conducted at screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery).|At screening (within 7 days prior to surgery) and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP. As there was no specific physical examination case report form used in this study, data on whether or not a physical examination was conducted were not recorded.||||||
1467411|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.8 (ranging from ~2 minutes to ~6 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.|||minutes||95% Confidence Interval|Geometric Mean
1467412|NCT00724932|Other Pre-specified|Mean Heart Rate|Heart Rate was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||beats per minute||Standard Deviation|Mean
1467413|NCT00724932|Other Pre-specified|Mean Diastolic Blood Pressure|Diastolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||mm Hg||Standard Deviation|Mean
1467414|NCT00724932|Other Pre-specified|Mean Systolic Blood Pressure|Systolic Blood Pressure was measured at screening, before start of rocuronium administration, before start of IMP administration, at 2, 5, 10, 30 minutes post-IMP administration, and at the post-anesthetic visit (the day after surgery).|At screening, pre-rocuronium, pre-IMP, at 2, 5, 10, and 30 minutes post-IMP, and at the post-anesthetic visit (the day after surgery)|The AST Population consisted of all randomized participants who received IMP.|||mm Hg||Standard Deviation|Mean
1467415|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of Reappearance of T2 in the 50 μg.Kg-1 Neostigmine Group|The time of reappearance of T2 refers to when the second twitch reappears after TOF stimulation. Reappearance of T2 was the target depth of NMB at which neostigmine was to be administered.|From last dose of rocuronium to reappearance of T2 (up to ~26 minutes)|The ITT Population consisted of all randomized participants who received neostigmine and had at least one efficacy measurement. The participants who received sugammadex were not included in this analysis.|||minutes||95% Confidence Interval|Geometric Mean
1467514|NCT00724815|Primary|Pain Free at Two Hours|Subjects whose headache severity score equaled zero (0) two hours post patch activation and who had not received any rescue medication before their two-hour assessment.|2 hours post patch activation|Per protocol, the intent-to-treat population was assessed.|||participants|||Number
1467416|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to the Time of 1-2 PTC in the 4.0 mg.Kg-1 Sugammadex Group|The time of 1-2 PTC refers to when 1-2 twitches are generated after tetanic stimulation. Time to 1-2 PTC is the time point of the last single twitch >0 or baseline (in case of noise or direct stimulation) within the sequence of a PTC measurement. 1-2 PTC was the target depth of NMB at which sugammadex was to be administered.|From last dose of rocuronium to 1-2 PTC (up to ~9 minutes)|The ITT Population consisted of all randomized participants who received sugammadex and had at least one efficacy measurement. The participants who received neostigmine were not included in this analysis.|||minutes||95% Confidence Interval|Geometric Mean
1467417|NCT00724932|Other Pre-specified|Time From Start of Administration of the Last Dose of Rocuronium to Recovery of the T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio indicates a faster recovery from NMB.|From start of last dose of rocuronium to recovery of T4/T1 Ratio to 0.5, 0.6, 0.7, 0.8 and 0.9 (ranging from ~12 minutes to ~36 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times from administration of last dose of rocuronium to recovery of the T4/T1 ratio to 0.5, 0.6, 0.7, 0.8 and 0.9.|||minutes||95% Confidence Interval|Geometric Mean
1467418|NCT00724932|Other Pre-specified|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.5 and 0.6|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). Faster times to recovery of the T4/T1 Ratios to 0.5 and 0.6 indicate faster recoveries from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.5 and 0.6 (ranging from ~1 minute to ~4 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. No imputation was done for missing times to recovery of the T4/T1 ratio to 0.5 and 0.6.|||minutes||95% Confidence Interval|Geometric Mean
1467419|NCT00724932|Secondary|Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0). A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 Ratio to 0.7 (ranging from ~2 minutes to ~5 minutes)|The ITT Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing recovery times.|||minutes||95% Confidence Interval|Geometric Mean
1467420|NCT00724932|Primary|Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Neostigmine) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9|Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.|From start of IMP administration to recovery of T4/T1 ratio to 0.9 (ranging from ~2 minutes to ~9 minutes)|The Intent-To-Treat (ITT) Population consisted of all randomized participants who received IMP and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.|||minutes||95% Confidence Interval|Geometric Mean
1467421|NCT00724893|Secondary|Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)|Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered “always” or “most of the time” to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants who completed the MAQ questionnaire during the study and achieved SVR|||percentage of participants|||Number
1467422|NCT00724893|Secondary|Number of Participants Achieving SVR by HIV Status (Stage 2)|"SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response no."|Up to 72 weeks|This analysis was not done.||||||
1467423|NCT00724893|Secondary|Number of Participants Achieving EVR by HIV Status (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|This analysis was not done.||||||
1467424|NCT00724893|Secondary|Number of Participants Achieving RVR by HIV Status (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|This analysis was not done.||||||
1467425|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467426|NCT00724893|Secondary|Number of Participants Achieving EVR by Gender (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467428|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467429|NCT00724893|Secondary|Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467430|NCT00724893|Secondary|Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1467431|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467432|NCT00724893|Secondary|Number of Participants Achieving EVR by Weight (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467433|NCT00724893|Secondary|Number of Participants Achieving RVR by Weight (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprises 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1467434|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)|SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467435|NCT00724893|Secondary|Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467436|NCT00724893|Secondary|Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1467437|NCT00724893|Secondary|Number of Participants Achieving EVR Who Achieved SVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication and achieved EVR|||participants|||Number
1467438|NCT00724893|Secondary|Number of Participants Achieving RVR Who Achieved SVR (Stage 2)|RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Week 4|Participants who achieved RVR|||participants|||Number
1467439|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467440|NCT00724893|Secondary|Number of Participants Achieving EVR by Race (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467441|NCT00724893|Secondary|Number of Participants Achieving RVR by Race (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1467442|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 2)|EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|Week 12|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467443|NCT00724893|Secondary|Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)|RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response “no”.|Week 4|The RVR analysis population comprised 388 participants who took at least one dose of study medication and were evaluated for RVR|||participants|||Number
1467444|NCT00724893|Secondary|Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT population); no participants had Genotype 5|||Participants|||Number
1467445|NCT00724893|Secondary|Relapse Rate by HCV Genotype (Stage 1)|The relapse rate was calculated with these parameters: EOT “yes”, EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 48 weeks|"All participants who took at least one dose of study medication (ITT population) and had EOT yes and valid EVR evaluation ; no participants had Genotype 5"|||Percentage of Participants|||Number
1467446|NCT00724893|Secondary|Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Week 12|The EVR analysis population comprised participants with HCV genotypes 1, 4, and 6 only, who took at least one dose of study medication; no participants had Genotype 5|||Participants|||Number
1467447|NCT00724893|Secondary|Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||particpants|||Number
1467448|NCT00724893|Secondary|Number of Participants With End of Treatment (EOT) Response (Stage 1)|EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as “not done” then EOT was set to “no”.|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1467449|NCT00724893|Secondary|Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467450|NCT00724893|Secondary|Number of Participants Achieving SVR by Race (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467451|NCT00724893|Secondary|Number of Participants Achieving SVR by Gender (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467452|NCT00724893|Secondary|Number of Participants Achieving SVR by EVR Type (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|The EVR analysis population comprised participants with HCV Genotypes 1, 4, 5, and 6 who took at least one dose of study medication. No participants had Genotype 5.|||participants|||Number
1467453|NCT00724893|Secondary|Number of Participants Achieving EVR (Stage 1)|EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response “no”.|From Week 10 to Week 14|The EVR analysis population comprised participants with HCV Genotypes 1, 4, and 6 only, who took at least one dose of study medication.|||participants|||Number
1467454|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1467455|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1467456|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population); no participants had Genotype 5|||participants|||Number
1467457|NCT00724893|Secondary|Number of Participants Achieving SVR by Weight (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467458|NCT00724893|Secondary|Number of Participants Achieving SVR by Viral Load (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467459|NCT00724893|Secondary|Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467460|NCT00724893|Secondary|Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467461|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
1467462|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population).|||Participants|||Number
1467463|NCT00724893|Secondary|The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data|||participants|||Number
1467464|NCT00724893|Secondary|The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)|Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data|||Participants|||Number
1467465|NCT00724893|Secondary|Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
1467466|NCT00724893|Secondary|Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
1467467|NCT00724893|Secondary|Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)|Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|Participants in the ITT population with EVR evaluation at Treatment Week 12|||Participants|||Number
1467468|NCT00724893|Secondary|Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment|Up to 48 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467469|NCT00724893|Primary|Number of Participants Achieving SVR (Stage 2)|SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467470|NCT00724893|Primary|Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)|This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
1467471|NCT00724893|Primary|Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)|This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response “no”.|Up to 62 weeks|All participants who took at least one dose of study medication (ITT population)|||Participants|||Number
1467472|NCT00724893|Primary|Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)|This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response “no”.|Up to 72 weeks|All participants who took at least one dose of study medication (ITT Population)|||participants|||Number
1467473|NCT00724867|Secondary|Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Percentage of participants with improvement in FACIT-Fatigue scale score exceeding the minimum clinically important difference (MCID) (>=4 points) are summarized. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Percentage of Participants|||Number
1467474|NCT00724867|Secondary|Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life experienced in the past 7 days. FACIT-Fatigue scale total score was assessed at BL (Day 0), Wk 48 in first year, at Wk 48 in subsequent Yrs up to 8 Yrs.The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). Change from BL in FACIT-Fatigue scale total score are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. A negative change from BL represents a worsening condition. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
1467490|NCT00724867|Primary|Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Millimeters of mercury||Standard Deviation|Mean
1467475|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints|The SF-36v2 is a participant-reported survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
1467476|NCT00724867|Secondary|Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point|The SF-36v2 is a participant-reported short form survey to measure functional health and well-being. There are 36 items grouped into eight health domains: Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. SF-36v2 gives a score (0-100) for each of these domains as well as summary score for the physical component score (PCS) and mental component score (MCS) based on the responses by participants. The lower the score the more disability and the higher the score the less disability. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from BL was calculated as the individual post-BL value minus the BL value. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Score on a scale||Standard Deviation|Mean
1467477|NCT00724867|Secondary|Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points|Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index is a tool used to assess non-reversible organ damage in SLE patients. Damage Index is used to assess 12 systems by 41 items. Score is given as 1 or sometimes 2, if occur more than once, so that that the maximum possible score is 47. Higher damage index scores early in disease are associated with a poor prognosis and with increased mortality. Damage index was assessed at BL (Day 0), Week 48 in first year, at Week 48 in subsequent years up to 8 years. Percentage of participants with worsening in damage index (change >0) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points were analyzed ( n=X).|Up to Week 384|MITT Population|||Percentage of Participants|||Number
1467478|NCT00724867|Secondary|Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Median percent change from Baseline in absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage change||Full Range|Median
1467479|NCT00724867|Secondary|Observed B-cell Levels at Indicated Time Points.|B-cell levels were assessed at Baseline (BL) (Day 0), Week (Wk) 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Observed absolute B cell subsets (CD20+), CD19+/27BRIGHT/38BRIGHT SLE subset, CD19+20-27hi+ short-lived plasma cells (SLPC), CD20+/138+ plasmacytoid, CD20+/27+ memory, CD20+/27- naïve, CD20+/69+activated, CD20-/138+ plasma cells, Total CD19+ B-cells (CD19+) levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Cell count||Full Range|Median
1467480|NCT00724867|Secondary|Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Trends for reduction in proteinuria in participants receiving belimumab were assessed up to 432 weeks and at Exit visit. Percentage of participants with >= 50% reduction in proteinuria among participants with Baseline proteinuria >0.5 g/24 hour (hr) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage of Participants|||Number
1467481|NCT00724867|Secondary|Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.|Trends for reduction in prednisone use in participants receiving belimumab were observed up to 432 weeks. Percentage of participants with daily prednisone dose reduced to <=7.5 mg/day from >7.5 mg/kg at the Baseline are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage of Participants|||Number
1467498|NCT00724867|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hemoglobin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Grams per liter||Standard Deviation|Mean
1467482|NCT00724867|Secondary|Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligrams per decilitre (mg/dL) and C4 <16 mg/dL). Median percent change from Baseline in complement C3 and C4 levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percent Change||Full Range|Median
1467483|NCT00724867|Secondary|Observed Complement C3 and C4 Levels at Indicated Time Points|Complement C3 and C4 levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at exit visit in participants with low complements at Baseline (C3 <90 milligram per deciliter (mg/dL) and C4 <16 mg/dL). Observed complement C3 and C4 levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Milligrams per deciliter||Full Range|Median
1467484|NCT00724867|Secondary|Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.|Anti-dsDNA levels were assessed at Baseline (BL) (Day 0), 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit in participants who were positive at baseline (anti-dsDNA ≥30 IU/mL). Median percent change from Baseline in anti-dsDNA levels are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Percent change from Baseline is calculated as: 100 x ([Post-Dose Visit Value – Baseline] / Baseline). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Percentage change||Full Range|Median
1467485|NCT00724867|Secondary|Observed Anti-double Stranded DNA Levels at Indicated Time Points.|Anti-double stranded deoxyribonucleic acid (anti-dsDNA) levels were assessed at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks in participants who were positive at baseline (anti-dsDNA >=30 International Units/milliliter [IU/mL]). Observed anti-dsDNA levels are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||International units per milliliter||Full Range|Median
1467486|NCT00724867|Secondary|Percentage of Participants Achieving SRI Response at Indicated Time Points|The percentage of participants achieving a SLE Responder Index (SRI) response at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion) are summarized. The BL is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Response is defined as:>=4 point reduction from the BL in the safety of estrogen in lupus national assessment (SELENA) SLE disease activity index (SLEDAI) score and no worsening (increase of <0.30 points from the BL) in Physicians Global Assessment (PGA), and no new British Isles Lupus Assessment Group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with the BL. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MIIT Population|||Percentage of Participants|||Number
1467487|NCT00724867|Secondary|Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.|Serum immunoglobulin G (IgG) was collected at Baseline (BL) (Day 0), at Week 24 and Week 48 in first year, at Week 48 in subsequent years up to 8 years and at follow-up (up to 8 weeks post last infusion). Number of participants with serum immunoglobulins below the lower limit of normal (LLN) (<0.5 nanograms per milliliter [ng/mL]) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 392|MITT Population|||Participants|||Number
1467488|NCT00724867|Primary|Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% reduction from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population. Only those subjects with abnormal (>124 umol/L) creatinine at baseline by year interval.|||Percentage of Participants|||Number
1467489|NCT00724867|Primary|Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.|Serum creatinine was assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Percentage of participants with at least 25% increase from baseline in creatinine are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Percentage of Participants|||Number
1467507|NCT00724854|Secondary|Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR|Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.|Treatment Week 48 and Treatment Week 72|Participants who achieved RVR at Treatment Week 4.|||Participants|||Number
1467491|NCT00724867|Primary|Number of Participants With the Indicated Immunogenic Response|Immunogenic response was assessed by binding confirmatory assay at Baseline (BL) (Day 0), at Week 24 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Number of participants with the indicated immunogenic response are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Results of binding confirmatory assay were categorized as negative, persistent positive (defined as a positive immunogenic response that occurs at least 2 consecutive assessments or a single result at the final assessment) or transient positive (defined as a single positive immunogenic response that does not occur at the final assessment). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Participants|||Number
1467492|NCT00724867|Primary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 432 weeks and at exit visit. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase and lactate dehydrogenase is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 432|MITT Population|||Units per liter||Standard Deviation|Mean
1467493|NCT00724867|Primary|Change From Baseline in BUN/Creatinine at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in BUN/creatinine is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Ratio||Standard Deviation|Mean
1467494|NCT00724867|Primary|Change From Baseline in Creatinine Clearance at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in creatinine clearance is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Milliliters per second||Standard Deviation|Mean
1467495|NCT00724867|Primary|Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in urate, creatinine and bilirubin is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Micromoles per liter||Standard Deviation|Mean
1467496|NCT00724867|Primary|Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in blood urea nitrogen, glucose, calcium, carbon dioxide, chloride, magnesium, phosphate, potassium and sodium is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Millimoles per liter||Standard Deviation|Mean
1467497|NCT00724867|Primary|Change From Baseline in Albumin and Protein at the Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in albumin and protein is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Grams per liter||Standard Deviation|Mean
1467508|NCT00724854|Secondary|Number of Participants With RVR Who Also Achieved SVR|RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.|Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)|Participants who achieved RVR at Treatment Week 4.|||Participants|||Number
1467509|NCT00724854|Secondary|Number of Participants Who Achieved Sustained Virologic Response (SVR)|SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.|Assessed at 24 weeks post-treatment||||Participants|||Number
1467499|NCT00724867|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in hematocrit is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Percentage||Standard Deviation|Mean
1467500|NCT00724867|Primary|Change From Baseline in Erythrocytes at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), at Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in erythrocytes is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Trillions cells per liter||Standard Deviation|Mean
1467501|NCT00724867|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, neutrophils segmented and platelets is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Billion cells per liter||Standard Deviation|Mean
1467502|NCT00724867|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline (BL) (Day 0), Week 4, 12, 24, 36 and 48 in first year, at Week 24 and 48 in subsequent years up to 440 weeks and at follow-up (up to 8 weeks post last infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post- Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Week 440|MITT Population|||Seconds||Standard Deviation|Mean
1467503|NCT00724867|Primary|SAE Rates by System Organ Class (SOC) During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an SAE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / participants Years. participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to Week 440|MITT Population|||Adverse events/100 participant-years|||Number
1467504|NCT00724867|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent adverse events (AEs) are summarized. The Baseline is defined as the Year 1 Day 0 values for participants treated with placebo in the parent study and last pre-treatment value in the parent study for participants treated with belimumab in the parent study. The event rate of an AE was calculated as the number of events per 100 participant years: Event Rate = 100* Number of Events / Participant Years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1]/365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up Week 440|MITT Population|||Adverse events/100 participant-years|||Number
1467505|NCT00724867|Primary|Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)|An AE is defined as any untoward medical occurrence in a participant (par.) temporally associated with the use of a investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. Only those participants available at the specified time points (represented by n=X, in the category titles) were analyzed.|Up to Week 440|Modified Intent to Treat (MIIT) Population: The MITT Population comprised of all the participants enrolled in the study who received at least one dose of IP.|||Participants|||Number
1467506|NCT00724854|Secondary|Assessment of Baseline Characteristics in Participants With SVR|Baseline characteristics assessed were age, gender, and genotype.|24 Weeks post-treatment|Participants with SVR|||Participants|||Number
1467510|NCT00724854|Primary|Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment|Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.|Assessed at Treatment Week 4||||Participants|||Number
1467515|NCT00724750|Secondary|Average Cost of Supplies and Rental|Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).|Participants were followed for the duration of inpatient stay, an average of 5 days.||||dollars||Standard Deviation|Mean
1467516|NCT00724750|Secondary|Pain Score With Dressing Changes|Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.|Participants were followed for the duration of inpatient stay, an average of 5 days.||||units on a scale||95% Confidence Interval|Mean
1467517|NCT00724750|Secondary|Average Time Spent on Dressing Changes|Time was measured from the start of the dressing change until the initiation of suction.|Participants were followed for the duration of inpatient stay, an average of 5 days.||||minutes||Standard Deviation|Mean
1467518|NCT00724750|Secondary|Failure to Maintain Dressing Because of Fluid or Suction Leaks||Participants were followed for the duration of inpatient stay, an average of 5 days.||||participants|||Number
1467519|NCT00724750|Primary|Percent Change Per Day in Wound Volume|Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days||||% change per day||95% Confidence Interval|Mean
1467520|NCT00724750|Primary|Percent Change Per Day in Wound Surface Area|Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.|7 days||||% change per day||95% Confidence Interval|Mean
1467521|NCT00724711|Secondary|Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Participants Enrolled after Amendment 3~Missing = Excluded"|||pg/mL||Standard Deviation|Mean
1467522|NCT00724711|Secondary|Change From Baseline Fibrinogen at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"|||mg/dL||Standard Deviation|Mean
1467523|NCT00724711|Secondary|Change From Baseline C-Reactive Protein at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"Treated Analysis Set, Subset of Subjects Enrolled after Amendment 3~Missing = Excluded"|||mg/dL||Standard Deviation|Mean
1467524|NCT00724711|Secondary|Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||Ratio||Standard Deviation|Mean
1467525|NCT00724711|Secondary|Change From Baseline Fasting Lipid Parameters at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mg/dL||Standard Deviation|Mean
1467526|NCT00724711|Secondary|Change From Baseline Fasting Glucose at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mg/dL||Standard Deviation|Mean
1467527|NCT00724711|Secondary|Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set|||mL/min/1.73m^2||Standard Deviation|Mean
1467528|NCT00724711|Secondary|Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|Treated Analysis Set: The treated analysis set included all randomized participants who received at least one dose of study drug. Participants who were randomized to continue ABC/3TC+PI/r during the study were included in the treated analysis set if they took at least one dose of their study drug after the baseline visit.|||mL/min||Standard Deviation|Mean
1467529|NCT00724711|Secondary|Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48|Change = Week 48 value minus baseline value|Baseline to 48 weeks|"ITT Analysis Set~Missing = Excluded: Participants with missing values were excluded from this analysis"|||cells/microliter||Standard Deviation|Mean
1467530|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~TLOVR: No virologic rebound on or before Week 48; no discontinuation before Week 48; no new ARV by study completion~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 50 copies/mL~Virologic Success: Last available HIV-1 RNA < 50 copies/mL in Week 48 window on randomized treatment"|||percentage of participants|||Number
1467531|NCT00724711|Secondary|Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized.|48 weeks|"ITT analysis set~Missing = Failure: Participants with missing values considered to have HIV-1 RNA levels >= 200 copies/mL~Virologic Success: Last available HIV-1 RNA < 200 copies/mL in the Week 48 window while on randomized treatment"|||percentage of participants|||Number
1467532|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set|||percentage of participants|||Number
1467533|NCT00724711|Secondary|Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48|The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|ITT Analysis Set|||percentage of participants|||Number
1475299|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSDBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
1467534|NCT00724711|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm|The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study.|Baseline to 48 weeks|Intent-to-treat (ITT) Analysis Set: Participants who were treated with at least one dose of study drug with no documented resistance to study drug prior to screening.|||percentage of participants|||Number
1467535|NCT00724698|Primary|Adverse Events|Number of adverse events reported|Final Visit (Day 15)||||adverse events reported|||Number
1467536|NCT00724594|Primary|PT||prior to delivery and in newborn DOL1|||||||
1467537|NCT00724594|Primary|Cerebral Blood Flow||prior to delivery and in newborn after delivery, during 2 days of NAC infusion|||||||
1467538|NCT00724594|Primary|Maternal and Infant Mean Blood Pressure Change||Maternal mean BP changes were pre/post dosing prior to delivery. Infant measurements were pre/post their first dosing|The infant and maternal populations analyzed for this portion are incomplete, as not all individuals had paired before/after blood pressure measurements at this time point.|||mmHg||Standard Deviation|Mean
1467539|NCT00724594|Primary|Placental Transfer Ratio|Ratio of NAC concentration in cord to maternal venous blood|At time of delivery||||ratio||Standard Deviation|Mean
1467540|NCT00724594|Secondary|Cytokine Levels in Plasma and CSF||During 2 days of NAC infusion|||||||
1467541|NCT00724594|Primary|NAC Concentrations||Peak: 30 minutes after NAC infusion. Cord: at delivery||||micromol/L||Standard Deviation|Mean
1467542|NCT00724594|Primary|NAC Total Body Clearance||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||mL/h/kg||Standard Deviation|Mean
1467543|NCT00724594|Primary|NAC Volume of Distribution||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||L/kg||Standard Deviation|Mean
1467544|NCT00724594|Secondary|Magnetic Resonance Spectroscopy of Infants||36 - 40 weeks gestational age|||||||
1467545|NCT00724594|Primary|NAC Terminal Elimination Half-life||prior to delivery in mothers, and in newborn after delivery during 2 days of NAC infusion||||hours||Standard Deviation|Mean
1467546|NCT00724568|Secondary|The Percentage of Patients That Achieved Partial or Complete Response to Treatment.|"Partial Response:~50% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.~If present, reduction in 24-hour urinary light chain excretion by either, greater than or equal to 90%, or to <200 mg for at least two determinations six weeks apart.~50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for at least six weeks.~No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).~Complete Response:~Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks.~<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks.~No increase in the size or number of lytic bone lesions."|24 weeks (8, 21-day cycles)|74 patients were enrolled, but 2 were not evaluable for dose limiting toxicities. 72 patients were included in this analysis.|||percentage of patients|||Number
1467547|NCT00724568|Primary|Maximum Tolerated Dose (MTD) of Combination Therapy With VELCADE, Dexamethasone, and Doxil, (RVDD)|"Dose Level 1:~15 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 2:~20 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 3:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 20 mg/m2 Doxil daily on day 4~Dose Level 4:~25 mg Revlimid daily on days 1-14 followed by 7-day rest every 21 days 1.3 mg/m2 Velcade daily on days 1, 4, 8 and 11 20 mg dexamethasone daily on Days 1, 2, 4, 5, 8, 9, 11, 12* and 30 mg/m2 Doxil daily on day 4"|1 month post treatment|A total of 74 patients were enrolled in this phase 1/2 study: 42 in phase 1.|||mg|||Number
1467548|NCT00724477|Primary|Number of Participants Reaching the Targeted LDL-C Levels|"A subject was considered to have met targeted LDL-C levels (been controlled) if:~subject had no cardiovascular (CV) risk factors and level of LDL-C after initiating INEGY was lower than 2.2 g/L,~subject had only 1 CV risk factor and level of LDL-C after initiating INEGY was lower than 1.9 g/L,~subject had 2 CV risk factors and level of LDL-C after initiating INEGY was lower than 1.6 g/L,~subject had 3 or more CV risk factors and level of LDL-C after initiating INEGY was lower than 1.3 g/L,~subject had a high CV risk and level of LDL-C after initiating INEGY was lower than 1 g/L."|1 to 3 months after starting treatment|This was the efficacy population per protocol (PP) targeted for study treatment, and consisted of patients having taken INEGY at least once, with a primary efficacy criterion available (presence of risk factors or not plus lipid assessment after introduction of INEGY), and showing no major deviations from the protocol.|||Participants|||Number
1467549|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule|SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.|24 weeks following completion of 24 or 48 weeks of therapy|No data had been captured in the Case Report Forms, and therefore no relevant analysis had been performed.||||||
1467559|NCT00724451|Secondary|Number of Participants Discontinued From Treatment by Reason for Discontinuation|Investigators recorded reasons for treatment discontinuation.|24 weeks after the end of treatment (total of 48 to 72 weeks)|Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants.|||participants|||Number
1467550|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 250 participants.|||Participants|||Number
1467551|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis.|||Participants|||Number
1467552|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 6 participants.|||Participants|||Number
1467553|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 32 participants.|||Participants|||Number
1467554|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. There was missing data for 157 participants.|||Participants|||Number
1467555|NCT00724464|Primary|Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up|Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.|||Participants|||Number
1467556|NCT00724464|Secondary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline|SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (N=309) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up. Of the 309 participants in this population, 286 achieved SVR and were included in this analysis. 23 participants were relapsers.|||Participants|||Number
1467557|NCT00724464|Primary|Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up|Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).|24 weeks following completion of 24 or 48 weeks of therapy|Efficacy Analysis Set (EAS) included all participants enrolled into the study who attended the final study visit and had HCV RNA evaluation measurement available at the 24-week post-treatment follow-up.|||Participants|||Number
1467558|NCT00724451|Secondary|Number of Participants With Treatment Failure by Reason for Failure|Investigators recorded reasons for treatment failure whether or not treatment was completed.|24 to 48 weeks|132 of the 500 treated participants failed treatment per Investigator assessment.|||participants|||Number
1467560|NCT00724451|Primary|Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility|Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant.|Measured at baseline|431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision.|||participants|||Number
1467561|NCT00724373|Primary|Participants With Treatment Success|Identify subgroups of genotype 1 participants to better understand factors affecting response rates & treatment outcomes & to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, & drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).|Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.|Number of participants who had treatment success.|||Participants|||Number
1467562|NCT00724347|Primary|.Speech Discrimination Ability|Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.|Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..|older hearing impaired listeners with hearing aids.|||signal to noise ratio in dB SNR||Standard Deviation|Mean
1467563|NCT00724308|Secondary|VA Site-level Performance Rates on the VA Tobacco Performance Measures||Quarterly after study implementation|||||||
1467564|NCT00724308|Secondary|Rate of Use of Smoking Cessation Medications (i.e., Treatment Rate)||2 and 6 months after enrollment|||||||
1467565|NCT00724308|Secondary|Quit Attempt Rate||2 and 6 months after enrollment|||||||
1467566|NCT00724308|Secondary|30-day Point Prevalence Abstinence Rate at 2-months (i.e., End of Treatment)||2 months after enrollment|||||||
1467567|NCT00724308|Primary|Long-term Smoking Abstinence (30-day Point Prevalence Abstinence)||6 months after enrollment||||participants|||Number
1467568|NCT00724282|Primary|Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test||at the end of each treatment|Investigator left university without analyzing data and no information is available on unblinding.||||||
1467569|NCT00724243|Primary|Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria|Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 14 and Week 54||||Participants|||Number
1467570|NCT00724243|Primary|Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment|The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.|Baseline, Week 14, and Week 54|"Thirty-three participants had a DAS 28 score at the beginning of treatment.~Twenty-eight participants had a DAS 28 score at Week 14.~Twenty-two participants had a DAS 28 score at Week 54."|||Units on a Scale||Standard Deviation|Mean
1467571|NCT00724152|Secondary|Tinnitus Reaction Questionnaire (TRQ)|This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach’s alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)|Period 1 and Period 2|||units on a scale ranging 0-104||Standard Deviation|Mean
1467572|NCT00724152|Primary|Tinnitus Handicap Inventory (THI)|Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients’ responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the “no handicap” range. This measure has strong internal consistency reliability (Cronbach’s alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score.|pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)|Period 1 and Period 2|||units on a scale of 0-100||Standard Deviation|Mean
1467589|NCT00723957|Secondary|Median Length of Survival in the Overall Population and in the Subgroups of Patients With βIII-tubulin Positive (β3T+) and βIII-tubulin Negative (β3T-)Tumors|Overall Survival was computed for all randomized participants and was defined as the time between randomization and death. Participants who did not die at the end of the study were censored at their last known alive date.|Randomization to death or last known alive date, up to 31.34 months|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
1475300|NCT00666536|Secondary|Change From Baseline to Weeks 2, 8 and 12 in MSSBP||Baseline and Weeks 2, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
1467573|NCT00724126|Secondary|Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6)|"The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of bloating was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.|||percentage of responders|||Number
1467574|NCT00724126|Primary|Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).|"The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug.~Adequate relief of global IBS symptoms was defined as a response of yes to the following question, which was asked weekly (every 7 days): In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"|4 weeks|The analysis population was the intent-to-treat population, defined as subjects who received at least 1 dose of study drug. Two randomized subjects (1 in each group) did not receive study drug and were not included in the intent-to-treat population.|||percentage of responders|||Number
1467575|NCT00724061|Other Pre-specified|Correlation of Response With Infiltration of Skin Lesions With Dendritic Cells, Cytotoxic CD8+ T-cells, and NK-cells||Baseline, 24 hours post-1st dose in the dose escalation phase, and 24 hours post-1st dose in the maintenance therapy phase|||||||
1467576|NCT00724061|Other Pre-specified|Change in Activation Status of Key Signaling Molecules Between Baseline and After 2 Weeks of Treatment|The activation status of key signaling molecules affecting the PI3K and JAK/STAT pathways was to be analyzed in samples of skin and blood taken at baseline and after 2 weeks of treatment. Participation in this exploratory component of the trial was optional for patients.|At baseline and after 2 weeks of treatment (for those patients who consented to this portion)|||||||
1467577|NCT00724061|Secondary|To Evaluate the Duration of Response|To evaluate duration of response related to combined pegylated IFN-α-2b plus PUVA or NB-UVB therapy.|At each study visit|||||||
1467578|NCT00724061|Secondary|Number of Patients Exhibiting a Complete Response|"Response was assessed according to the Composite Assessment of Index Lesion Disease Severity. Clinical signs are graded on scales of 0 to 8 (0 being no evidence of disease and 8 being the near worst severity of sign/symptom). The CA response is calculated as the ratio of the sum of the grades for all clinical signs plus the surface areas for all index lesions at each visit compared to the sum of these grades at baseline. The CA also considers all other cutaneous lesions and any extra-cutaneous manifestations of disease.~CR requires a CA ratio of 0 (zero) with no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells are considered to be not significant). Skin biopsy is required for documentation of CR."|From the date the first patient begins treatement until the last patient achieves complete response (response was assessed every 4 weeks)|||||||
1467579|NCT00724061|Primary|Change in Total Health-related Quality of Life Score Using the Functional Assessment of Cancer Therapy – Biologic Response Modifier (FACT-BRM)|The FACT-BRM is a patient self-report tool to assess health-related quality of life measures.|From the date that the first patient was registerd until the last patient came off treatment (score assessed at baseline, every 2 weeks during dose escalation, and then monthly during maintenance therapy for each patient)|||||||
1467580|NCT00724061|Primary|Number of Dose Limiting Toxicities (DLTs) Observed During Dose Escalation of PEG-IFN-α-2b|"Adverse events are graded according to the National Cancer Institute's Common Toxicity Criteria (CTCAE) version 3.0. In general, grades are assigned as follows:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~A dose limiting toxicity (DLT) will be defined as any grade 3 or higher hematologic toxicity or any grade 4 non-hematologic toxicity."|From the date that the first patient began treatment until the last patient completed the dose escalation phase (up to 12 weeks per patient)||||dose limiting toxicities|||Number
1467581|NCT00724009|Secondary|Leukemia Free Survival|Time to event analysis used the day of transplant as day 0.|2 years|One patient with refractory AML underwent conditioning but died 1 day before stem cell infusion due to sepsis (grade 5 infection)|||days||95% Confidence Interval|Median
1467582|NCT00724009|Secondary|Number of Participants Infection Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1467583|NCT00724009|Secondary|Number of Participants With Skin Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1467584|NCT00724009|Secondary|Number of Participants With Cardiac Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1467585|NCT00724009|Secondary|Number of Participants With Hepatic (SGOT) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1467586|NCT00724009|Secondary|Number of Participants With Hepatic (Total Bilirubin) Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1467587|NCT00724009|Secondary|Number of Participants With Renal Adverse Events|Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Day 12||||participants|||Number
1467588|NCT00724009|Primary|Cytoreductive Response|Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%|Day 12||||percentage of participants|||Number
1467675|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 2)|Heart rate was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1467590|NCT00723957|Secondary|Number of Participants With Grade 3 or 4 Abnormalities in Liver Function and Urine Laboratory Test Results|ULN=upper level of normal. Alkaline phosphatase (ALP) Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Aspartate aminotransferase (AST) Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN|At screening and within 72 hours of start of 21-day cycle (Cycle 2 and beyond)|All participants who received any investigational product.|||Participants|||Number
1467591|NCT00723957|Secondary|Number of Participants With Hematology Laboratory Results of Grade 3 or 4|LLN=lower level of normal. Leukocytes (leukopenia) Grade 1: <LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3: <2.0 to 1.0*10^9/L, Grade 4: <1.0*10^9/L; Neutrophils (neutropenia) Grade 1: <LLN to 1.5*10^9/L, Grade 2: <1.5 to 1.0*10^9/L, Grade 3: <1.0 to 0.5*10^9/L, Grade 4: <0.5*10^9/L; Platelet count(thrombocytopenia) Grade 1: LLN to 75.0*10^9/L, Grade 2: <75.0 to 50.0*10^9/L, Grade 3: <50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L; Hemoglobin (anemia) Grade 1: <LLN to 10.0 g/dL, Grade 2: <10.0 to 8.0 g/dL, Grade 3: <8.0 to 6.5 g/dL, Grade 4: <6.5 g/dL.|At screening and weekly during 21-day cycle|All participants who received any investigational product.|||Participants|||Number
1467592|NCT00723957|Secondary|Number of Participants With Death as Outcome, Drug-related Adverse Events (AEs), Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation, and Drug-related Peripheral Neuropathy|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as possibly, probably, or certainly related to and of unknown relationship to study treatment.|Days 1 through 21, continuously|All participants who received any investigational product.|||Participants|||Number
1467593|NCT00723957|Secondary|Time to Response|Time to Response is defined as the time from randomization date until the date of first response (Partial Response [PR] or Complete Response [CR])|Randomization to date of first response (PR or CR)|All randomized participants|||Weeks||Full Range|Median
1467594|NCT00723957|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR)|Response evaluated per Response Evaluaton in Solid Tumor (V1.0) guidelines and assessed using magnetic resonance imaging. Percentage of best response=the total number of participants with the best overall response of CR or PR divided by the total number of randomized participants in that treatment arm. CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|At randomization and then every 6 weeks to date of CR, PR, or progression for 6 21-day cycles||||Percentage of participants||95% Confidence Interval|Mean
1467595|NCT00723957|Secondary|Progression-free Survival in the Overall Population|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death, assessed to 12.29 months|All randomized participants who received study drug|||Months||95% Confidence Interval|Median
1467596|NCT00723957|Secondary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Negative Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on study tumor assessment, progression-free survival was censored at the date of randomization.|Randomization to disease progression or death (maximum reached: 12.29 months)|All randomized participants who had βIII-tubulin positive tumors and who received study drug|||Months||95% Confidence Interval|Median
1467597|NCT00723957|Primary|Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors|Progression-free survival is defined as the period from date of randomization to date of disease progression or death. For participants who do not progress or die at the end of the study, progression-free survival was censored at the last tumor assessment date. For those who have no on-study tumor assessment, progression-free survival was censored at the date of randomization. A tumor was considered to be beta III (βIII)-tubulin positive if 50% or more of the tumor cells had a βIII-tubulin immunohistochemistry staining intensity equal to or greater than that of the positive control.|Randomization to disease progression or death (maximum reached: 14.39 months )|All randomized participants with βIII-tubulin positive tumors and who received study drug|||Months||95% Confidence Interval|Median
1467598|NCT00723944|Secondary|Osseous Integration||4 years|||||||
1467599|NCT00723944|Primary|Crestal Bone Regression (Amount of Bone Measured) Around Each Implant Unit|Millimeters of crestal bone observed and measured in a radiograph of each study implant is measured and averaged to obtain the mean crestal bone loss or gain for each implant unit.|1 year|population represents all patients receiving test and control implants enrolled in the study, but only those implants achieving integration (lack of mobility) were analyzed and reported here up to the 12 months follow-up stage.|||millimeters|implants|Standard Error|Mean
1467600|NCT00723931|Primary|Number of Participants That Reported a Non Serious Adverse Event Above 5 Percent Threshold|Adverse events (AE's) were events that resulted in unintended signs, symptoms or illnesses. All non-serious adverse events related or unrelated to the study drug and those AE's determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection.||||Participants|||Number
1467601|NCT00723931|Primary|Number of Participants That Reported a Serious Adverse Event|Serious adverse events (SAE's) were events that resulted in death, were life threatening, required hospitalization, caused disability, and congenital anomaly. All SAE's related or unrelated to the study drug and those SAE's that were determined by the investigator, using specific criteria defined in the protocol, were reported.|24 weeks after administration of PegIntron Injection||||Participants|||Number
1467602|NCT00723892|Secondary|the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol||12 months after onset of treatment|Participants with no missing results.|||Weeks||Standard Deviation|Mean
1467603|NCT00723892|Primary|Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.||12 months after onset of treatment|Participants foreseen to complete treatment, consulted and assigned to treatment were analyzed.|||Participants|||Number
1467604|NCT00723840|Primary|EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease|"EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score >= 150.~EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.|||Score on a scale|||Number
1467605|NCT00723840|Primary|Cost of Illness in Participants With Crohn's Disease|"Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score >= 150.~Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss."|Baseline, 6, 12, and 18 months|Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.|||Euros|||Number
1467606|NCT00723827|Primary|Efficacy: Number of Participants Experiencing Complete Response (CR), Partial Response (PR), or Stable Disease(SD)|The response ratings were based on the judgment of the investigator.|Complete study duration (up to approximately 6.5 months)||||participants|||Number
1467607|NCT00723827|Primary|Number of Temozolomide Drug Interactions|Drug interaction was defined as a chemical or physiological reaction that can occur when two different drugs are taken together.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||events|||Number
1467608|NCT00723827|Primary|Number of Temozolomide Misuse or Abuse Events|"Drug abuse was defined as the use of the study drug for a non-therapeutic effect.~Misuse was defined as use of the study medication in a way that was not prescribed."|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||Events|||Number
1467609|NCT00723827|Primary|Number of Participants Experiencing Unexpected Adverse Drug Reactions (ADRs)|An unexpected ADR was defined as an adverse reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||participants|||Number
1467610|NCT00723827|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, whether or not considered related to the medicinal product.|Complete study duration & 30 days after completion (up to approximately 7.5 months)||||participants|||Number
1467611|NCT00723801|Secondary|Diastolic Function - Ejection Fraction|Two-dimensional echocardiography was performed using a 3.0 MHz transducer (General Electric VIVID 7). Left ventricular and left atrial dimensions were determined in parasternal long axis views. Left ventricular ejection fraction was calculated using the modified Simpsons calculation in the apical two and four chamber views.|Baseline and 6 months||||Change in % ejection fraction||Standard Deviation|Mean
1467612|NCT00723801|Primary|Aortic Biophysical Properties - Pulse Wave Velocity|Aortic stiffness was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, West Ryde, NSW, Sydney, Australia) to measure carotid to femoral artery pulse wave velocity (PWV). With the patient lying supine in a quiet environment, a handheld micromanometer-tipped probe was applied to the skin surface over the carotid and femoral arteries, compressing the vessel wall so that transmural forces within the vessel wall were perpendicular to the arterial surface. The distance from the sternal notch to the sites of carotid and femoral pulse acquisition were measured and inputted into the device to represent the relative distance from the carotid to femoral artery. The calculation of distance divided by time of pulse upstroke relative to the upstroke of the QRS on a 3 lead surface EKG was used by the device to calculate velocity. All recorded measurements met the manufacturer’s quality control standards integrated into the software package.|Baseline and 6 months||||change in meters/second||Standard Deviation|Mean
1467613|NCT00723788|Primary|Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up|Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)|during diagnostic procedure|All patients received MRI, of those 20 also received US and 9 CT, meaning that 8 patients received all three procedures.|||participants|||Number
1467614|NCT00723749|Secondary|Drug Craving (Subjective Effects of Therapy)|Circumstances of switching to SUBOXONE®: Analyse change of drug craving for opiates by using a 100mm visual analog scale (minimum: 0 = no craving; maximum: 100 = high craving)|Baseline and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||Units on a scale||Standard Deviation|Mean
1467615|NCT00723749|Secondary|Take Home Prescriptions of SUBOXONE®|"Circumstances of switching to SUBOXONE®: Analyze if the number of take home prescriptions of SUBOXONE®, reported by the treating physician, increase between day 1 and the final assessment.~Take Home prescription is defined as a prescription of up to 7 daily dosages SUBOXONE® from the treating physician which allows the patients to receive the prescribed amount of daily dosages SUBOXONE® from a pharmacy to take home and dispense the medication on his own on a daily basis.~A patient can receive only one take home prescription for up to 7 days at the time."|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||participants with take home prescription|||Number
1467616|NCT00723749|Primary|Retention Rate After 12 Months of Treatment With Suboxone|The primary aim of the SUBOXONE® NIS was to document the 12-month retention rate for at least N = 300 subjects with opioid dependence in a real-life scenario in at least N = 70 sites throughout Germany.|12 months|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||% of participants||95% Confidence Interval|Number
1467617|NCT00723749|Secondary|Dosage of SUBOXONE®|Circumstances of switching to SUBOXONE®: Analyse induction and maintenance dose of SUBOXONE®.|Day 1 and Final Assessment (month 12 or time of dropout)|The analysis cohort included all patients prospectively documented, with informed consent, at least 15 years of age at enrollment with written consentment to treatment of drug dependence, for whom SXN-therapy was indicated and planned and with documentation for at least visit 1, visit 2 and visit 12 (end-of-study or discontinuation documentation).|||mg daily dosage of Suboxone||Standard Deviation|Mean
1467618|NCT00723736|Primary|Proportion of Patients With Adverse Events|An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.|Follow-up visit at 3 - 5 weeks after treatment initiation||||participants|||Number
1467619|NCT00723710|Primary|Number of Participants Who Completed Treatment|Treatment completion was defined as those who completed both the induction and maintenance phases.|Up to 1 year|The number of participants who started the induction phase|||Participants|||Number
1467620|NCT00723697|Primary|Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician.|Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|All eligible patients|||participants|||Number
1467621|NCT00723697|Secondary|Number of Patients Reporting Clinical Consequences of Engaging in Misuse|Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit.|first visit, 6 months, and 12 months|Number of patients analyzed for the consequence, at each visit.|||participants|||Number
1467622|NCT00723697|Primary|Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents)|Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits.|first visit, 6 months, and 12 months|Number of patients with self-questionnaire responses.|||participants|||Number
1467623|NCT00723645|Secondary|Percentage of Participants Who Relapsed After EOT at Week 72 (Late Relapser)|"Late relapse was defined as having a Sustained Viral Response (SVR) at 24 weeks of follow-up and subsequently having a positive viral load 48 weeks later at Week 72.~SVR was defined as negative for HCV RNA at Week 24 of follow-up."|From 24 weeks post-treatment to 72 weeks post-treatment|"The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment and also virus-negative at Week 24 (Visit 2).~187 participants completed Visit 2, 14 participants were excluded from analysis, and 173 participants were evaluable for Week 72 (Visit 3)."|||Percentage of participants||95% Confidence Interval|Number
1467624|NCT00723645|Primary|Percentage of Participants With Relapse At 24 Weeks After the End Of Treatment (EOT)|"Relapse rate is defined as the percentage of participants with negative viral load (HCV RNA-) at EOT who have positive viral load (HCV RNA+) at 6 months after EOT.~RNA= Ribonucleic Acid"|From enrollment (≤4 weeks after end of treatment) to Week 24 post-treatment|The evaluable population consisted of all enrolled participants who were virus negative at the end of treatment. 249 participants were evaluable for Week 24 (Visit 2).|||Percentage of participants||95% Confidence Interval|Number
1467625|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Prior Treatment Status|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
1467626|NCT00723632|Secondary|Average Cost Per Participant With SVR Stratified by Ribavirin Dosage|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with HCV genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
1467627|NCT00723632|Primary|Average Cost Per Participant With Sustained Virologic Response (SVR) Stratified by Weight Category|SVR is defined as undetectable HCV ribonucleic acid (RNA) six months after the end of treatment. Cost per participant with SVR was calculated as a ratio of the total costs for all participants and the number of participants with SVR in the given group. All costs were adjusted for inflation to 2010 values.|From enrollment up to 48 weeks for participants with hepatitis C virus (HCV) genotype 1, and from enrollment up to 24 weeks for participants with HCV genotypes 2 and 3|Participants were included in the analysis if all of the following conditions were met: initial exam form was completed; at least 1 follow up visit form was completed; the end of treatment (either according to plan or early) was recorded; and SVR status was recorded six months after treatment termination.|||Czech Crown||Full Range|Mean
1467628|NCT00723606|Secondary|Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours|BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake [normal level of activity]; 5 = signs of overt [physical or verbal] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1467629|NCT00723606|Secondary|Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours|CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1467630|NCT00723606|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1467631|NCT00723606|Secondary|Change From Baseline in BPRS Agitation Subscale Score at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.|Baseline, 72 hours|FAS. Missing data were replaced by LOCF.|||scores on a scale||Standard Error|Least Squares Mean
1467632|NCT00723606|Secondary|BPRS Agitation Subscale Response at 72 Hours|The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a > 30 percent reduction from baseline in BPRS agitation subscale score.|72 hours|FAS. Missing data were replaced by last observation carried forward (LOCF).|||participants|||Number
1467633|NCT00723606|Primary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours|BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.|Baseline, 72 hours|Per protocol (PP) population = Full Analysis Set (FAS) subjects (ie, randomized subjects who took at least one dose of study medication) who provided a baseline and 72 hour BPRS total score and did not deviate from the protocol in a significant manner.|||scores on a scale||Standard Error|Least Squares Mean
1467634|NCT00723580|Secondary|The Personality Inventory for Children: Family Relations Scale|The factors that underlie this scale are family stability, inter-parent communication, presence of love and happiness in the home and appropriateness of discipline. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1467635|NCT00723580|Secondary|The Personality Inventory for Children: Social Skills Scale|The factors that underlie this scale are social success, social rejection, adults as only social contacts, and the ability to lead and follow. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1467636|NCT00723580|Secondary|The Personality Inventory for Children: Withdrawal Scale|The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function|May-7-2008 to July -14-2010|||||||
1467637|NCT00723580|Secondary|The Personality Inventory for Children: Delinquency Scale|The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May 7, 2008-July 14,2010|||||||
1467638|NCT00723580|Secondary|The Personality Inventory for Children: Somatic-Physiological Scale|The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1467639|NCT00723580|Secondary|The Personality Inventory for Children: Achievement Scale|The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function.|May-7-2008 to July -14-2010|||||||
1467640|NCT00723580|Secondary|The Personality Inventory for Children: Adjustment Scale|This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment and developmentally associated change.|May-7-2008 to July -14-2010|||||||
1467641|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Hyperactivity Observed||May-7-2008 to July -14-2010|||||||
1467642|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Distractibility Observed||May-7-2008 to July -14-2010|||||||
1467643|NCT00723580|Secondary|Systematic Observation Scale: Percentage of Irritability Observed||May-7-2008 to July -14-2010|||||||
1467673|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 2)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1467644|NCT00723580|Secondary|Systematic Observation Scale Item: Percentage of Impulsivity Observed|The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation.|May-7-2008 to July -14-2010|||||||
1467645|NCT00723580|Primary|Actigraphic Measurement of Treatment Conditions|The child’s impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions.|May 12- July 14, 2010|Single subject repeated Actigraphic(at thirty second intervals), observational (every two months) and psychometric (baseline and at 23 months) measurements of a child anticipating pharmacological treatment. Actigraphic measurements (three 21 day periods) over five treatment conditions that included a non-medication baseline and spanned 23 months.|||activity|Participants|Standard Deviation|Mean
1467646|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 3, End of Study Visit|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467647|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worse Patient Global Self Assessment - Change From Previous Visit to Period 2, Day 28|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467648|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 3, End of Study Visit))|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467649|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-15 (Period 2, Day 28)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the EOS visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467650|NCT00723554|Secondary|Patient Global Self Assessment - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|"The Patient Global Self Assessment is a 7-point scale that was presented to patients prior to conducting visit-specific study procedures. Patients were asked to compare their current PAH status to their status in the past by selecting one of the following options: markedly better; moderately better; mildly better; no change; mildly worse; moderately worse; or markedly worse.~On Day 1 prior to their first dose of iloprost with PD-15 (Baseline), patients were asked to compare their PAH status to that during Screening (if the Screening and Baseline visits were conducted on the same day, then patients were asked to compare their PAH status to that in the past 2 weeks). On Day 28 and at the end of study (EOS) visit, patients were asked to compare their PAH status to that of the previous visit."|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467674|NCT00723554|Primary|Heart Rate - Iloprost PD-15 (Period 3)|Heart rate was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1467651|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 3, End of Study Visit)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467652|NCT00723554|Secondary|Number of Patients With Improved, no Change, or Worsening of NYHA Functional Class - (Period 1, Prior to First Dose With Iloprost PD-15 to Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467653|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 3, End of Study Visit))|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 268 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467654|NCT00723554|Secondary|NYHA Functional Class - Iloprost PD-15 (Period 2, Day 28)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467655|NCT00723554|Secondary|New York Health Association (NYHA) Functional Class - Iloprost PD-6 (Period 1, Prior to First Dose With Iloprost PD-15)|Disease severity was assessed by NYHA classification of PAH criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||participants|||Number
1467656|NCT00723554|Secondary|Change in Percentage of Complete Doses Delivered - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1467657|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1467658|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1467659|NCT00723554|Secondary|Percentage of Complete Doses Delivered - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||percentage of complete doses||Standard Deviation|Mean
1467660|NCT00723554|Secondary|Change in Average Number of Daily Doses - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1467661|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1467662|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1467663|NCT00723554|Secondary|Average Number of Daily Doses - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||doses per day||Standard Deviation|Mean
1467664|NCT00723554|Secondary|Change in Average Number of Days of Dosing - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1467665|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1467666|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1467667|NCT00723554|Secondary|Average Number of Days of Dosing - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||days||Standard Deviation|Mean
1467668|NCT00723554|Secondary|Change in Average Inhalation Time - (Period 1 to Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average approximately 56 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1467669|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 3)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 240 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1467670|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-15 (Period 2)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1467671|NCT00723554|Secondary|Average Inhalation Time - Iloprost PD-6 (Period 1)|The time and date of inhalation, inhalation time (minutes), and dose completion status (<12.5%, ≥12.5 to <100%, full) were recorded in the memory chip of the I-neb® AAD® each time it was used.|average of approximately 28 days|Modified intent-to-treat (MITT) population - includes all enrolled patients without major protocol violations, who received at least one dose of iloprost with PD-15, and had one or more post-baseline evaluations for pharmacodynamic endpoints.|||minutes||Standard Deviation|Mean
1467672|NCT00723554|Primary|Change in Heart Rate - (Period 1 to Period 3)|Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||beats per minute||Standard Deviation|Mean
1467677|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 3)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467678|NCT00723554|Primary|Change in Diastolic Blood Pressure - (Period 1 to Period 2)|Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467679|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 3)|Diastolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467680|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-15 (Period 2)|Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467681|NCT00723554|Primary|Diastolic Blood Pressure - Iloprost PD-6 (Period 1)|Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1||||mmHg||Standard Deviation|Mean
1467682|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 3)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)|Day 1 and End of study visit, an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467683|NCT00723554|Primary|Change in Systolic Blood Pressure - (Period 1 to Period 2)|Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)|Day 1 and Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467684|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 3)|Systolic blood pressure was measured at the end of study visit|an average of approximately 268 days|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467685|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-15 (Period 2)|Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15|Day 28|Safety population - missing data were not imputed|||mmHg||Standard Deviation|Mean
1467686|NCT00723554|Primary|Systolic Blood Pressure - Iloprost PD-6 (Period 1)|Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15|Day 1|Safety population|||mmHg||Standard Deviation|Mean
1467687|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Serious AEs|Number of patients reporting at least one treatment-emergent serious AEs|From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population|||participants|||Number
1467688|NCT00723554|Primary|Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE|Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment|From the first dose of investigational product to study discontinuation, an average of approximately 268 days|Safety population|||participants|||Number
1467689|NCT00723554|Primary|Number of Patients Reporting Treatment-emergent Adverse Events (AEs)|Number of patients reporting at least one treatment-emergent AE/Serious AE|From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours|Safety population|||participants|||Number
1467690|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.|||Percentage of participants|||Number
1467691|NCT00723528|Secondary|Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12|Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.|||Percentage of participants|||Number
1467692|NCT00723528|Secondary|Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64|Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1467693|NCT00723528|Secondary|Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64|The number of nails with psoriasis involvement was assessed by a dermatologist.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Nails||Standard Deviation|Mean
1467694|NCT00723528|Secondary|Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).|Week 12, 28, 40,52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1467695|NCT00723528|Secondary|Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64|The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1467696|NCT00723528|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.|Week 12, 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1467697|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 28, 40, 52 and 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.|||Unit on scale||Standard Deviation|Mean
1467698|NCT00723528|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.|||Percentage of participants|||Number
1467699|NCT00723528|Secondary|Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.|||Percentage of treatment response||Standard Deviation|Mean
1467700|NCT00723528|Secondary|Psoriasis Area and Severity Index (PASI) Score|PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).|Week 64|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.|||Units on a scale||Standard Deviation|Mean
1467701|NCT00723528|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).|Week 12|"The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on scale||Standard Deviation|Mean
1467702|NCT00723528|Primary|Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score|Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.|Week 12|The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.|||Percentage of participants|||Number
1467703|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1467704|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD8 Positive T-cells, YFV-17D SC –(AD) Compared to YFV-17D SC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD8 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD8 Positive T-cells.|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1467705|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive , CD4 Positive T-cells, YFV-17D TC – (AD) Compared to YFV-17D TC – (Non-AD) Participants|Comparison by designated reporting groups: the Log10 transformed count of CD4 Positive T-cells that express IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T- Cells (Day 30). A higher count reflects a better immune response to Yellow Fever virus.|Day 30 (Day 28-35)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1467706|NCT00723489|Secondary|Comparison in Log10 Transformed Lymphocyte Count on Day 30 Post YF Immunization: IFN-gamma Positive, Tumor Necrosis Factor- Alpha (TNF Alpha) Positive, CD4 Positive T-cells, YFV-17D SC – (AD) Compared to YFV-17D SC – (Non- AD) Participants|Comparison by designated reporting groups: the Log10 transformed lymphocyte count of CD4 Positive T-cells expressing IFN-gamma and TNF-alpha in every 10^6 CD4 Positive T-cells on Day 30 (acceptable blood draw window: Day 28 – 35).|Day 30 (Day 28-35)|Analysis excludes 1 SC-(AD) participant who did not seroconvert, 1 SC-(Non-AD) participant whose samples were collected out of window, and 3 SC (Non-AD) and 1 SC-(AD) due to problems with sample processing|||Log10 cell count/10^6 cells||Standard Deviation|Mean
1467707|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters|||participants|||Number
1467708|NCT00723489|Secondary|Comparison of Count of Seroconverters: YFV-17D TC– (AD) Participants Compared to YFV-17D TC – (Non-AD) Participants|Seroconversion is defined as a Log10 Neutralization Index (LNI) of 0.7 or higher. A value greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|Day 0 to Day 30 (Acceptable Post-Vaccination Blood Draw Range: Day 28 - Day 35)|Includes all participants who completed the study; seroconverters as well as non-seroconverters|||participants|||Number
1467709|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D SC – (AD) Participants Compared to YFV-17D SC – (Non-AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||Log10 (NT50)||Standard Deviation|Mean
1467710|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralizing Titer 50 (NT50): YFV-17D TC – (AD) Participants Compared to YFV-17D TC – (Non – AD) Participants|Neutralization titer (NT50) is the dilution of serum (antibody) that results in a 50% reduction in the amount of virus. A higher NT50 number reflects the presence of more protective antibody levels against the Yellow Fever virus. Some studies have used an NT50 titer of 1:10 or 1:20 as the minimum level to suggest that a person has active immunity against the Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||Log10 (NT50)||Standard Deviation|Mean
1467711|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D SC – (AD) Participants Compared to YFV-17D SC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after YF immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after Yellow Fever immunization)|All participants who completed the study; and seroconverted|||Log10 Neutralization Index (LNI)||Standard Deviation|Mean
1467712|NCT00723489|Primary|Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC– (AD) Participants Compared to YFV-17D TC– (Non-AD) Participants|Log10 Neutralization Index (LNI) is the Log10 difference in virus titer (measurement of amount of virus) between pre-vaccination and post-vaccination. An LNI greater than or equal to 0.7 suggests that a person has active immunity against Yellow Fever virus.|30 days after Yellow Fever (YF) immunization (Acceptable Blood Draw Range: Day 28 - Day 35 after YF immunization)|All participants who completed the study; and seroconverted|||LNI||Standard Deviation|Mean
1467732|NCT00723450|Secondary|Time From Randomization to Intervention for a Mood Episode (TIME)|The time from randomization to the intervention for a mood episode (depression, mania/hypomania or mixed mood) was analyzed. TIME was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for a mood episode (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
1467713|NCT00723450|Secondary|Change From Randomization in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Randomized Phase.|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467714|NCT00723450|Secondary|Change From Baseline in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Open-Label Phase|The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467715|NCT00723450|Secondary|Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467716|NCT00723450|Secondary|Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase|The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467717|NCT00723450|Secondary|Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467718|NCT00723450|Secondary|Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase|The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467719|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Randomization in the Randomized Phase|The CGI-BP(I) asks the following question: “Compared to the Randomization assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Participants|||Number
1467720|NCT00723450|Secondary|Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Baseline in the Open-Label Phase|The CGI-BP(I) asks the following question: “Compared to the Baseline assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.|||Participants|||Number
1467721|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase|Improvement of bipolar illness was based on the CGI-BP(I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Randomization weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32 and 36|Randomized ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Randomized ITT Population.|||Scores on a scale||Standard Deviation|Mean
1467722|NCT00723450|Secondary|Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase|Improvement of bipolar illness was based on the CGI-BP (I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.|||Scores on a scale||Standard Deviation|Mean
1467723|NCT00723450|Secondary|Change From Randomization in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467724|NCT00723450|Secondary|Change From Baseline in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase|Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467725|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Randomization and Weeks 8, 16, 24, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467726|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase|The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.|Baseline and Weeks 4, 8, 12, 16, and 18|Open-Label ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467727|NCT00723450|Secondary|Change From Randomization in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36|Randomized ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
1467728|NCT00723450|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase|The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18|Open-Label ITT population: all participants who entered the Open-Label Phase and received at least one dose of LTG.|||Scores on a Scale||Standard Error|Least Squares Mean
1467729|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase|The proportion of participants (par.) requiring intervention to treat either the emergence of or a change in bipolar symptoms, that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state at any time within the first 30, 90, and 180 days in the Randomized Phase were analyzed.|From randomization up to Week 36|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.|||Participants|||Number
1467730|NCT00723450|Secondary|Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State|The number of participants requiring intervention to treat either the emergence of or a change in bipolar symptoms that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state were analyzed.|From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36)|Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.|||Participants|||Number
1467731|NCT00723450|Secondary|Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix)|The time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix) was analyzed. TIDep, TIMan, and TIMix were calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
1467750|NCT00723229|Secondary|Duration of Genital HSV Shedding Episodes|Median duration of HSV shedding episodes, in hours|9 weeks|Only episodes of known duration were included|||Hours|Episodes|Inter-Quartile Range|Median
1467733|NCT00723450|Secondary|Time From Randomization to Withdrawal From the Study for Any Cause (TTW)|The time from randomization to the withdrawal from study was analyzed. TTW was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until withdrawal from the study for any cause (up to Week 36)|Randomized ITT Population|||Days||Standard Error|Mean
1467734|NCT00723450|Primary|Time From Randomization to the Occurrence of a Bipolar Event (TOBE)|TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).|From randomization until Week 36|Randomized Intent-to-Treat (ITT) Population: all participants who were randomized to LTG or placebo and received at least one dose of investigational product.|||Days||Standard Error|Mean
1467735|NCT00723294|Secondary|Pain Assessment||Up to 14 days post surgery||2017-12-31|12/2017||||
1467736|NCT00723294|Secondary|Adverse Events||Up to 14 days post surgery||2017-12-31|12/2017||||
1467737|NCT00723294|Secondary|Negative Predictive Value of MRI|Negative predictive value of MRI: The negative predictive rate of MRI will be estimated as the number of patients with no residual disease upon pathologic review of the resected tissue AND with a MRI that indicated no residual disease divided by the number of patients who had an MRI that indicated no residual disease. Both a binomial point estimate and 90% two-sided confidence interval will be computed.|Up to 14 days post cryoablation|One patient had bilateral disease and therefore outcomes are reported for 87 cancers.|||percentage of cancers|cancers|90% Confidence Interval|Number
1467738|NCT00723294|Primary|Rate of Complete Tumor Ablation|The primary endpoint for this study is the rate of complete ablation. Complete ablation is defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion. The rate (percentage) will be computed as the number of patient lesions with complete tumor ablation divided by the total number of eligible patient lesions. This rate will be estimated by the binomial point estimate (number of patients with no pathological evidence of residual disease in the targeted lesion after ablation divided by the number of eligible patients) and a one-sided 90% binomial confidence interval (interval with a lower bound).|Up to 14 days post surgery|One patient had bilateral disease and therefore outcomes are reported for 87 lesions.|||percentage of lesions|lesions|90% Confidence Interval|Number
1467739|NCT00723255|Secondary|Progression-free Survival at 6 Months by Tumor Grade|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
1467740|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Tumor Grade|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
1467741|NCT00723255|Secondary|Progression-free Survival at 6 Months by Histologic Type|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
1467742|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Histologic Type|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
1467743|NCT00723255|Secondary|Progression-free Survival at 6 Months by Performance Status|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months||||percentage of participants||95% Confidence Interval|Number
1467744|NCT00723255|Secondary|Complete and Partial Tumor Response by RECIST 1.0 by Performance Status|Complete and Partial Tumor Response by RECIST 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease||||percentage of participants||95% Confidence Interval|Number
1467745|NCT00723255|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From entry into the study to death or the date of last contact, up to 5 years|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1467746|NCT00723255|Secondary|Progression-Free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|Eligible and Treated Patients|||Months||95% Confidence Interval|Median
1467747|NCT00723255|Primary|Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Every cycle and 30 days after the last treatment, an average of 5 years.|Eligible and evaluable patients|||Participants|||Count of Participants
1467748|NCT00723255|Primary|Progression-free Survival at 6 Months|Percentage of patients who are progression-free 6 months after study entry. Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Every other cycle for 6 months|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1467749|NCT00723255|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Scans are done while patient is on study therapy every other cycle for the first 6 months; then every 3 cycles thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
1467751|NCT00723229|Secondary|Number of Genital HSV Shedding Episodes|The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs|9 weeks|The number of participants analyzed is the same as the overall number. No participants were excluded from this analysis.|||Episodes|||Number
1467752|NCT00723229|Secondary|Quantity of HSV Detected, Median|Median quantity of HSV detected, among swabs with any HSV detected|9 weeks|The number of swabs with HSV detected was analyzed. This is a subset of overall numbers of swabs collected, since not all swabs had HSV detected.|||log 10 copies/ml|Swabs|Inter-Quartile Range|Median
1467753|NCT00723229|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.||9 weeks|Participants collected at least one swab on each study arm|||percentage of swabs with HSV detected|Swabs||Number
1467754|NCT00723203|Primary|Hematological Response Rate|Morphologic CR: morphologic leukemia-free state with absolute neutrophil count > 1000/uL and platelet count ≥ 100,000/uL and independent of blood transfusions. Cytogenic CR: morphologic CR along with reversion to a normal karyotype by cytogenetic analysis. Molecular CR: morphologic CR with no residual disease by molecular or flow cytometric detection methods. Morphologic CR with incomplete blood recovery (CRi): morphologic CR except for residual neutropenia (<1000/uL) and/or thrombocytopenia (<1000,000/uL). PR: same hematologic values for a CR but with a decrease of at least 50% in percentage of blasts to a post-treatment value of 5% to 25% in bone marrow aspirate. (If the pre-treatment blast percentage was 50-100% this must decrease to a value between 5-25%. If the pre-treatment blast percentage was 20-49% this must decrease by at least half to a value > 5%.) A value ≤ 5% is also considered a PR if Auer rods are present. Hematological response = morphologic CR+PR.|Up to 6 cycles of treatment, up to 24 weeks.|Three patients of the 16 accrued were not included in the analysis for response per protocol due to patient refusal for alternative treatment prior to completing the first cycle of treatment.|||percentage of responding participants|||Number
1467755|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-I scale:~1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1467756|NCT00723190|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) at Months 1, 2, 3, 4, 6, 9, and 12|"CGI-S scale:~1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients"|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1467757|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of Heart Rate at Week 4||At baseline and at Week 4|Data analysis involved the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||beats per minute||Standard Deviation|Mean
1467758|NCT00723190|Primary|Change From Baseline in Heart Rate at Week 4|Heart rate was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||beats per minute||Standard Deviation|Mean
1467759|NCT00723190|Primary|Change From Baseline in Body Temperature at Week 4|Temperature was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement|At baseline and at Week 4|Data analysis was performed on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Fahrenheit||Standard Deviation|Mean
1467760|NCT00723190|Primary|Change From Baseline in Systolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||mmHg||Standard Deviation|Mean
1467761|NCT00723190|Primary|Change From Baseline in Diastolic Blood Pressure at Week 4|Blood pressure was measured with the subject in a sitting position and resting for at least 2 minutes prior to taking the measurement. The dominant arm was used for the measurement|At baseline and at Week 4|Data was anlyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||mmHg||Standard Deviation|Mean
1467762|NCT00723190|Primary|Change From Baseline in Body Weight at Weeks 1, 2, 3, 4, and Months 2, 3, 4, 5, 6, 9, and 12||At baseline and at weeks 1, 2, 3, 4, and months 2, 3, 4, 5, 6, 9, and 12|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Kilograms||Standard Deviation|Mean
1467763|NCT00723190|Primary|Change From Baseline in 12-lead Electrocardiogram in Terms of QT, QTc Fridericia (QTcF), and QTc Bazett’s (QTcB) at Week 4||At baseline and at Week 4|Data was analyzed based on safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||milliseconds||Standard Deviation|Mean
1467764|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analysis were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Events|||Number
1467784|NCT00723021|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.|||ng/mL||Standard Deviation|Mean
1467765|NCT00723190|Secondary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHDRS-IV Scale) (18 Items Scored, 0 [Never/Rarely] to 3 [Very Often]; Total Possible Score Range, 0-54) at Months 1, 2, 3, 4, 6, 9, and 12|The ADHDRS-IV consists of 18 items designed to reflect symptoms of ADHD. Each item is scored on a scale of 0 (Never or rarely) to 3 (Very Often). The subscales of the ADHDRS-IV included the Inattention and the hyperactivity/Impulsivity subscales (total possible score range, 0-54). The Inattention subscale consists of the sum of 9 items: 1, 3, 5, 7, 9, 11, 13, 15, and 17. The Hyperactivity/Impulsivity subscale consists of the sum of 9 items: 2, 4, 6, 8, 10, 12, 14, 16, and 18|At baseline, months 1, 2, 3, 4, 6, 9, and 12|Efficacy summaries and analyses are based on the efficacy evaluable population which included subjects who took one or more doses of study medication and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Deviation|Mean
1467766|NCT00723190|Primary|Safety Assessment in Terms of Adverse Events (Treatment-emergent [TEAEs] and Serious [SAEs])|Safety assessments were performed at each study visit according to the time and events schedule. All safety analyses were based on safety population|1 year|The analysis of the safety data was performed for the safety population which included subjects who took one or more doses of study medication. All subjects in the trial are included in the safety population|||Participants|||Number
1467767|NCT00723177|Secondary|The Effects of AV411 on the Analgesic Effects of Oxycodone.|The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.|Measured at the end of each AV411 of the three two-week maintenance periods||||units on a scale||Standard Deviation|Mean
1467768|NCT00723177|Primary|Subjective Opioid Withdrawal Scale Score (SOWS)|Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.|Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).|Only 30 of the total number of 44 enrolled completed the study .|||units on a scale||Standard Error|Mean
1467769|NCT00723125|Secondary|Measure of Safety and Tolerability According to CTC Version 3.0||2 years|||||||
1467770|NCT00723125|Primary|Pathological Complete Response Rates at Surgery||at surgery approximately 5 months after initial treatment|Cohort1: 33 pts enrolled to cohort 1,33 underwent surgery even if they did not complete all treatment Cohort 2: 27 enrolled to cohort 2 and 27 underwent surgery, even if they did not complete all treatment|||participants|||Number
1467771|NCT00723073|Secondary|Duration of Neutropenia|Median number of days patients were neutropenic during the study period|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
1467772|NCT00723073|Secondary|Duration of Hospitization|Median number of days patients were hospitalized during the study period|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
1467773|NCT00723073|Secondary|Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation|The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy|11/1/2005 - 10/31/2007||||participants|||Number
1467774|NCT00723073|Secondary|Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy|aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5x the upper limit of normal (ULN) or total bilirubin > 3x the upper limit of normal (ULN)|11/1/2005 - 10/31/2007||||participants|||Number
1467775|NCT00723073|Secondary|Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN)|median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)|11/1/2005 - 10/31/2007||||days||Inter-Quartile Range|Median
1467776|NCT00723073|Primary|Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy|Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy|11/1/2005 - 10/31/2007||||participants|||Number
1467777|NCT00723073|Primary|Absence of Any Breakthrough Invasive Fungal Disease (IFD)|a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed > 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin|11/1/2005 - 10/31/2007||||participants|||Number
1467778|NCT00723073|Primary|Mortality at Hospital Discharge|We assessed all patients in the study cohort who dischaged from the hospital alive|11/1/2005 - 10/31/2007||||participants|||Number
1467779|NCT00723073|Primary|Successful Treatment of Any Baseline Invasive Fungal Disease (IFD)|Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia|11/1/2005 - 10/31/2007||||participants|||Number
1467780|NCT00723073|Primary|Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN)|Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.|11/1/2005 - 10/31/2007||||participants|||Number
1467781|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]|AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).|14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.||||||
1467782|NCT00723021|Other Pre-specified|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level.||||||
1467783|NCT00723021|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.||||hrs||Full Range|Median
1467785|NCT00723021|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.|All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period.|||ng*h/mL||Standard Deviation|Mean
1467786|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1467787|NCT00723021|Secondary|Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)|The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L/Sec||Standard Deviation|Mean
1467788|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline,24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1467789|NCT00723021|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1467790|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 24 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1467791|NCT00723021|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|The FEV1 is the maximal volume of air that can be forcefully exhaled in one second|Baseline, 12 hours (hrs) post-dose|All enrolled participants treated who had at least 1 concentration in at least 1 treatment period|||L||Standard Deviation|Mean
1467792|NCT00723008|Primary|Mean General Sleep Disturbance Scale (GSDS) Score|The GSDS is a questionnaire used to qualitatively evaluate sleep. This 21-question tool evaluates each aspect of sleep and restfulness on a 0-7 score, indicating the number of days per week that each problem may be present. Total scores range from 0-147, with higher scores indicating more profound disturbances in sleep.|Baseline, Week 4, Week 8|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Score||Standard Deviation|Mean
1467793|NCT00723008|Primary|Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their anxiety level before and after each daily CES treatment. Responses were scored on a scale ranging from 0 (indicating no anxiety) to 10 (worst possible).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval|||VAS-A Score||Standard Deviation|Mean
1467794|NCT00723008|Primary|Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).|Subjects were asked to evaluate their pain intensity before and after each daily CES or sham treatment. Responses were scored on a scale ranging from 0 (indicating no pain) to 10 (worst possible pain).|Blinded Period, Unblinded Period|All subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||VAS-P Score||Standard Deviation|Mean
1467795|NCT00723008|Primary|Mean Brief Profile of Mood States (BPOMS) Score|BPOMS is a tool used to qualitatively measure anxiety. Subjects were asked to evaluate 30 feelings that they may have had over the past week. Stress-associated feelings are scored on a 5-point Likert scale from 0 (not at all)to 4 (extremely). Six of the feelings listed on the questionnaire are not associated with anxiety and therefore are not scored. Total scores range from 0-96, with higher scores indicating greater tension and anxiety.|Baseline, Week 4, Week 8|One A:Active/Unblinded subject was removed from analysis due to a 39-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Brief POMS Score||Standard Deviation|Mean
1467796|NCT00723008|Primary|Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score|This 20-item questionnaire measures depressive symptoms. Scores can range from 0-60, with scores greater than 16 indicating need for further evaluation due to possible Major Depression.|Baseline, 4 Weeks, 8 Weeks|One A:Active/Unblinded subject was removed from analysis due to a 31-point outlying score. All other subjects who remained in study at each given period were analyzed. Therefore, the number of subjects examined decreased at each interval.|||Score||Standard Deviation|Mean
1467797|NCT00723008|Primary|Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score|Subjects were asked to complete questionnaire three times during the course of study. Questions addressed symptoms associated with Post Traumatic Stress Disorder(PTSD). Scores can range from 17 to 85. A score >31 was used to identify symptomatic subjects and was therefore required at baseline for study enrollment.|Baseline, Week 4, Week 8|All active subjects|||Score||Standard Deviation|Mean
1467798|NCT00722865|Secondary|Safety|Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)|2 years||||Participants|||Count of Participants
1467799|NCT00722865|Secondary|Overall Survival|Overall survival: patients are still alive.|2 years||||Participants|||Count of Participants
1467800|NCT00722865|Secondary|Progression-free Survival|Progression-free survival: a patient lives with the disease but it does not get worse.|2 years and medium follow-up of 18 months||||percentage of participants||90% Confidence Interval|Number
1467801|NCT00722865|Secondary|Overall Response Rate Using the Modified Cheson Criteria|Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT|2 years||||percentage of participants||90% Confidence Interval|Number
1467802|NCT00722865|Primary|Failure-free Survival|Failure-free survival: the absence of relapse, non-relapse mortality or addition of another systemic therapy|2 years and median follow-up of 18 months||||percentage of participants||90% Confidence Interval|Number
1467803|NCT00722800|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.|Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst).|6 months||||points||Standard Deviation|Mean
1467804|NCT00722800|Secondary|Change From Baseline in VAS Pain Scale at Month 6.|"For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated no pain and a score of 10 indicated worst pain. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity."|6 months from Baseline||||units on a scale||Standard Deviation|Mean
1467805|NCT00722800|Primary|Mean Improvement in the Sartorius Severity Score at Month 6.|The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease.|6 months||||units on a scale||Standard Deviation|Mean
1467806|NCT00722761|Secondary|Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination|Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100.|24 weeks|Intention to treat analysis. Participants with at least one follow up visit were included in the analysis. Last observation carried forward was used to fill up missing values/|||percentage of participants|||Number
1467807|NCT00722761|Primary|Percent Change in Truncal Lesion Counts|Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions.|0-24 weeks|Intention to treat analysis. Only participants with at least one follow up were included in the analysis. Last observation carried forward was used to fill up missing data.|||percentage change of lesions||Standard Deviation|Mean
1467808|NCT00722722|Primary|Response to Bortezomib Monotherapy|Response to treatment with Bortezomib (BTZ) alone was defined as a reduction in serum Donor Specific Alloantibody (DSA) levels following treatment. DSA levels were measured prior to treatment and after treatment. A good response occurred if all DSA were reduced. A partial response when a reduction was observed in at least one DSA, but not all DSA. No response occurred when no reduction of any DSA was attained.|6 months|In the 32 dose group, one patient received a kidney transplant with a B-cell flow cytometric crossmatch channel shift of less than 300 after dose 20 and was transplanted with a positive crossmatch donor. This patient was then excluded from further DSA analysis.|||participants|||Number
1467809|NCT00722566|Secondary|Number of Patients With Complete Response|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks."|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.|||Participants|||Number
1467810|NCT00722566|Primary|Number of Patients With Overall Response (Complete Response + Partial Response)|"Disease response was measured according to European Group for Blood and Marrow Transplantation (EBMT) criteria with the addition of the response categories of nCR and VGPR.~Complete response requires disappearance of monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks.~Partial Response requires ≥50% reduction in serum m-protein for at least 2 determinations at least 6 weeks apart and if present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg"|Over 4 cycles (prior to the addition of dexamethasone)|The response-evaluable population was defined as subjects who received at least 1 dose of study drug and had measurable, secretory multiple myeloma, defined as a serum monoclonal IgG or IgM of ≥10 g/L or a serum monoclonal IgA or IgE ≥5 g/L, or a serum monoclonal IgD of ≥0.5g/L, or urine M-protein of ≥200 mg/24 hours, at study entry.|||Participants|||Number
1467811|NCT00722553|Secondary|Overall Survival (OS)|The number of days from study day 1 to death. Patients who had not died (no record of death) or were lost to follow-up were censored at the date of last contact.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care if treatment has ended (at least every 12 weeks) for up to 2 years after enrollment. After PD or start of subsequent treatment, OS will be assessed every 4 months.|Analysis per protocol. Patients who had not died or were lost to follow-up were censored|||Months||95% Confidence Interval|Median
1467812|NCT00722553|Secondary|Progression Free Survival (PFS)|Length of time from study day 1 to the date of radiological evidence of PD (date of computed tomography [CT] or magnetic resonance imaging [MRI] scan, whichever indicates PD) or death, regardless of cause.|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.|Analysis was per protocol, based on the number of patients (pts) who had an event of progressive disease (PD) or death. Pts who did not have an event at the time of data cut-off were censored.|||Months||95% Confidence Interval|Median
1467813|NCT00722553|Secondary|Clinical Benefit Rate (CBR)|The number of patients with a best confirmed or unconfirmed response of CR, PR, or stable disease (SD) for at least 24 weeks (approximately 5.5 months)|Assessed at the end of each even-numbered cycle (every 8 weeks) or per standard of care, but no more than every 12 weeks (+/- 1 week) if treatment has ended, for up to 2 years after enrollment.||||participants|||Number
1467814|NCT00722553|Secondary|Duration of Response (DOR)|Duration of time from when tumor measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent disease or progressive disease (PD) or death was objectively documented. Progression is defined, using RECIST, as an increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. Calculated for those patients with a best overall confirmed or unconfirmed response of CR or PR.|Measured from the first day of documented response for up to 2 years after enrollment.|Analysis was per protocol, based on the number of all responding patients both confirmed and unconfirmed (n=5) in the evaluable population (n=30)|||Days||95% Confidence Interval|Median
1467815|NCT00722553|Primary|Objective Response Rate (ORR)|The number of patients with a best overall confirmed response of either complete response (CR) or partial response (PR)|Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no more than every 12 weeks (+/- 1 week) if treatment has ended for up to 2 years after enrollment.||||participants|||Number
1467816|NCT00722436|Secondary|Platelets||baseline, after osteotomies, immediately after surgery||||10^9 platelets/L||Standard Deviation|Mean
1467817|NCT00722436|Secondary|Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).||(baseline, after osteotomies, and immediately after procedure)||||seconds||Standard Deviation|Mean
1467818|NCT00722436|Primary|Number of Patients That Remained Transfusion Free||24 hours||||participants|||Number
1467819|NCT00722436|Primary|Total Volume (ml/kg) of Allogeneic Blood Exposure.|This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.|intraoperative and postoperative (24 hr)||||ml/kg||Standard Deviation|Mean
1467820|NCT00722423|Secondary|Antiviral Treatment Rate|Number of patients started antiviral treatment|12-24 weeks post-treatment||||percentage of participants|||Number
1467821|NCT00722423|Primary|Sustained Virologic Response Rates|Virus not detected by PCR assay|12-24 weeks post-treatment||||participants|||Number
1467822|NCT00722371|Secondary|Change From Baseline in 2-Hour PMG at Week 54|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1467823|NCT00722371|Secondary|Change From Baseline in FPG at Week 54||Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1467824|NCT00722371|Primary|Change From Baseline in A1C at Week 54|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 54|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1467825|NCT00722371|Secondary|Change From Baseline in 2-Hour Post-meal Glucose (PMG) at Week 24|PMG was measured using the Meal Tolerance Test (MTT).|Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1467826|NCT00722371|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24||Baseline and Week 24|Full Analysis Set with LOCF. Reasons for exclusion included no baseline data and/or no post-baseline data.|||mg/dL||95% Confidence Interval|Least Squares Mean
1467827|NCT00722371|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|A1C represents the percentage of glycosylated hemoglobin.|Baseline and Week 24|Full Analysis Set with last observation carried forward (LOCF). Reasons for exclusion included no baseline data and/or no post-baseline data.|||Percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
1467828|NCT00722137|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug.|Up to 107.4 months|The safety population was defined as all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
1467829|NCT00722137|Secondary|Overall Survival (OS) in Long Term Follow-up Period|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Up to 107.4 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1467830|NCT00722137|Secondary|18-Month Survival|18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).|Up to month 18 from the time of randomization|The population consisted of all randomized participants.|||Percentage of Participants||95% Confidence Interval|Mean
1467831|NCT00722137|Secondary|Overall Survival (OS)|OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1467832|NCT00722137|Secondary|Overall Complete Response (CR + CRu)|Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Participants|||Number
1467851|NCT00721955|Secondary|CGI-I Responders|Frequency of response based on the CGI-I (defined as achieving a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation)|Baseline and 2 hours|ITT Population with LOCF|||Participants|||Count of Participants
1468015|NCT00721188|Primary|Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug/dL||Standard Deviation|Mean
1467833|NCT00722137|Secondary|Overall Response Rate (ORR)|ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Participants|||Number
1467834|NCT00722137|Secondary|Treatment-free Interval (TFI)|The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.|Median duration of follow-up of 40 months|All randomized participants who received at least 1 dose of study medication.|||Days||95% Confidence Interval|Median
1467835|NCT00722137|Secondary|Time to Next Anti-lymphoma Treatment (TTNT)|The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.|: Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1467836|NCT00722137|Secondary|Duration of Response|The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).|Median duration of follow-up of 40 months|The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had >= 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment.|||Days||95% Confidence Interval|Median
1467837|NCT00722137|Secondary|Time to Progression (TTP)|Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1467838|NCT00722137|Primary|Progression Free Survival (PFS)|PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.|Median duration of follow-up of 40 months|The population consisted of all randomized participants.|||Days||95% Confidence Interval|Median
1467839|NCT00722124|Primary|7-day Point Prevalence Smoking Abstinence at End of Treatment (Week 8)|7-day point prevalence smoking abstinence biochemically confirmed (expired carbon monoxide <8ppm)|8 weeks|Analysis was performed using intention to treat(ITT). Subjects who discontinued study participation were assumed to be smoking.|||participants|||Number
1467840|NCT00722111|Primary|Maximum Isometric Tongue Pressure|Peak isometric pressure at 4 sensors|16 months|PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available.Data was only available for two arms. All efforts were made to retrieve data.|||kPa||Full Range|Mean
1467841|NCT00722111|Primary|Isometric Lingual Pressure|Tongue Strength|8 weeks|PI is not available, thus the numbers presented are what was initially entered by research team. For the other treatment arms, data is unavailable, as PI is not available. Data was only available for one arm. All efforts were made to retrieve data.|||kPa||Full Range|Mean
1467842|NCT00722072|Secondary|Overall Survival||28 to 56 days after discontinuation of study therapy|Long term survival data was not collected due to early study termination||||||
1467843|NCT00722072|Secondary|Progression-free Survival||Start of treatment to time of progression or death, whichever comes first.|Long term survival data was not collected due to early study termination||||||
1467844|NCT00722072|Secondary|Time to Progression||Start of treatment to time of progression.|Progression data was not collected due to early study termination.||||||
1467845|NCT00722072|Secondary|Objective Response Rate||Every 8 weeks (two cycles) while receiving study therapy.|Response assessment data was not collected past 4 months due to early study termination.||||||
1467846|NCT00722072|Primary|Number of Participants With Progression-free Survival at 4 Months|Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).|4 months after initiating treatment with sorafenib plus fulvestrant.||||Participants|||Number
1467847|NCT00722020|Secondary|Secondary Endpoint Total Hospital Length of Stay|Seconadary endpoint was Total Hospital length of stay|30 Days||||days||Standard Deviation|Mean
1467848|NCT00722020|Primary|The Primary Endpoint Will be Time to Readiness for Discharge.|Days in the hospital prior to patient being clinically ready to discharge|30 days|asthmatic children|||days||Standard Deviation|Mean
1467849|NCT00721968|Other Pre-specified|Number of Ocular Hypotensive Medications by Visit||12 months||||medications||Standard Deviation|Mean
1467850|NCT00721968|Primary|Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications|Percent reaching this endpoint|12 months|Number of subjects at Month 12 with IOP ≤ 18 mmHg without topical hypotensive medications|||participants|||Number
1475301|NCT00666536|Secondary|Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)||Baseline and Week 4|Intent to treat (ITT), Last observation carried forward (LOCF)|||mmHg||Standard Deviation|Mean
1467852|NCT00721955|Secondary|Clinical Global Impression-Improvement (CGI-I) Score Following Dose #1 of Staccato Loxapine, Compared With Placebo|Clinical Global Impression- Improvement (CGI-I) scores ranged from 1 to 7: 0=not assessed (missing), 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
1467853|NCT00721955|Primary|Change in PANSS Excited Component (PEC) Score From Baseline Following Dose #1 of Staccato Loxapine, Compared With Placebo|The Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (min) to 7 (max). The PANSS-EC, the sum of these 5 subscales, thus ranges from 5 to 35. Individuals were eligible if they had a PANSS-EC of ≥14 (out of 35) and a score ≥4 (out of 7) on at least 1 of the 5 items.|Baseline and 2 hours|ITT Population with LOCF|||units on a scale||Standard Deviation|Mean
1467854|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change||Standard Deviation|Mean
1467855|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-Patlak||Standard Deviation|Mean
1467856|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-FLT||Standard Deviation|Mean
1467857|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmax||Standard Deviation|Mean
1467858|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmean||Standard Deviation|Mean
1467859|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467860|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1467861|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat).Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1467862|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467863|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467901|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467864|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467865|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1467866|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate K-FLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1467867|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mm^3 (cubic milimeters)||Standard Deviation|Mean
1467868|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467869|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467870|NCT00721799|Primary|Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change||Standard Deviation|Mean
1467871|NCT00721799|Primary|Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-Patlak||Standard Deviation|Mean
1467872|NCT00721799|Primary|Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in K-FLT||Standard Deviation|Mean
1467873|NCT00721799|Primary|Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmax||Standard Deviation|Mean
1467874|NCT00721799|Primary|Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent both the pre-therapy and mid-therapy FLT PET scan|||percentage change in SUVmean||Standard Deviation|Mean
1467875|NCT00721799|Primary|Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1468141|NCT00720473|Primary|Mean Glutamine to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||mean serum Glutamine to Creatine ratio||Standard Deviation|Mean
1467876|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the mid-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1467877|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the mid-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1467878|NCT00721799|Primary|Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467879|NCT00721799|Primary|Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed.|36 months|Participants who underwent the mid-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467880|NCT00721799|Primary|Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467881|NCT00721799|Primary|Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis.|36 months|Participants who underwent the pre-therapy FLT PET scan|||l/min||Standard Deviation|Mean
1467882|NCT00721799|Primary|Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mL/g/min||Standard Deviation|Mean
1467883|NCT00721799|Primary|Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)|Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||mm^3 (cubic milimeters)||Standard Deviation|Mean
1467884|NCT00721799|Primary|Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467885|NCT00721799|Primary|Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)|Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed.|36 months|Participants who underwent the pre-therapy FLT PET scan|||standardized uptake value (SUV)||Standard Deviation|Mean
1467886|NCT00721734|Secondary|Time to Progression (TTP)|Time to Progression is defined as the time from first dose of carfilzomib to disease progression. Median TTP was estimated using Kaplan-Meier methods.|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population|||months||95% Confidence Interval|Median
1467902|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population with available data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467903|NCT00721734|Secondary|Maximum Observed Plasma Concentration of Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467887|NCT00721734|Secondary|Duration of Response|"Duration of Response is defined as the time from first evidence of PR or better to confirmation of disease progression or death.~Progressive disease was defined as any of the following:~An increase of more than 25% from nadir in any one of the following:~M-protein in serum (the absolute increase had to be ≥ 0.5 g/dL);~Urine (the absolute increase had to be ≥ 200 mg/24 hours);~The difference between involved and uninvolved sFLC (the absolute increase in the concentration of involved light chain had to be > 10 mg/dL);~≥ 10% bone marrow infiltration by plasma cells;~Increased size of pre-existing bone lesions or plasmacytomas or new bone lesions or plasmacytomas.~Median duration of response was estimated using the Kaplan-Meier method."|Participants were followed for disease progression for up to 2 years.|Response Evaluable Population with a best overall response of sCR, CR, VGPR, or PR.|||months||95% Confidence Interval|Median
1467888|NCT00721734|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate is defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a reduction of M-protein in serum of 25% to 49% and in urine of 50% to 89% from baseline, maintained for at least 6 weeks.|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population|||percentage of participants||95% Confidence Interval|Number
1467889|NCT00721734|Secondary|Overall Response Rate (ORR)|"ORR is defined as the percentage of participants with a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Uniform Response Criteria for Multiple Myeloma.~sCR: CR as defined below plus normal serum free light chain (sFLC) ratio and absence of clonal plasma cells in bone marrow by immunohistochemistry or immunofluorescence; CR: absence of M-protein in serum and urine confirmed by immunofixation and < 5% plasma cells in the bone marrow; VGPR: serum and urine M-proteins detectable by immunofixation, but not by electrophoresis or a ≥ 90% reduction in serum M-protein from baseline, plus a urine M-protein level of < 100 mg/24 hours; PR: reduction of M-protein in serum of ≥ 50% and in urine of ≥ 90% from baseline. If serum and urine M-protein were not measureable at baseline, a ≥ 50% decrease in the difference between involved and uninvolved sFLC levels from baseline."|From first dose until 30 days after the last dose; median duration of treatment across all groups was 121 days.|The response evaluable population included all participants with measurable disease and a baseline and at least 1 post-baseline disease assessment or who discontinued study treatment due to a related adverse event prior to obtaining an on-study disease assessment.|||percentage of participants||95% Confidence Interval|Number
1467890|NCT00721734|Secondary|Plasma Protein Binding (PPB) of Carfilzomib|The plasma protein binding (PPB) of carfilzomib in plasma samples was determined using a rapid equilibrium dialysis (RED) device. Data are averages of the 3 time points (Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15).|End of injection and 5 minutes post-dose on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 15|Participants with available data|||percentage of carfilzomib bound||Standard Deviation|Mean
1467891|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1467892|NCT00721734|Secondary|Percentage of Carfilzomib Metabolites Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of the metabolites of carfilzomib (PR-389/M14 and PR-413/M15) excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1467893|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 15 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 15, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1467894|NCT00721734|Secondary|Percentage of Carfilzomib Excreted Via Renal Elimination on Day 1 of Cycle 1|The percentage of carfilzomib excreted in urine was calculated as the total amount excreted over 24 hours/dose.|Cycle 1, Day 1, 0-5 and 5-24 hours post-dose|Participants in Groups 1-4 with available data|||percentage of carfilzomib dose||Standard Deviation|Mean
1467895|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467896|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467897|NCT00721734|Secondary|Area Under the Concentration Time Curve to the Last Measurable Concentration (AUClast) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467898|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467899|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population with available data|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467900|NCT00721734|Secondary|Area Under the Plasma Curve Extrapolated to Infinity (AUCinf) for Carfilzomib on Day 1 of Cycle 1||Cycle 1, Day 1, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|PK evaluable population; AUCinf could not be estimated for 11 participants in the PK population who did not have adequate PK data.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467904|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 2||Cycle 2, Day 15, before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data|||liters/hour||Standard Deviation|Mean
1467905|NCT00721734|Secondary|Clearance (CL) of Carfilzomib on Day 15 of Cycle 1||Cycle 1, Day 15 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|The pharmacokinetic (PK) evaluable population with available data|||liters/hour||Standard Deviation|Mean
1467906|NCT00721734|Primary|Clearance (CL) of Carfilzomib on Day 1 of Cycle 1|Plasma concentrations of carfilzomib was determined by a validated liquid chromatography tandem mass spectrometry (LC MS/MS) method. The lower limit of quantitation (LLOQ) was 0.300 ng/mL. Concentration values that were below the LLOQ (BLQ) were set to zero. Pharmacokinetic (PK) parameters were calculated from the individual plasma concentrations of carfilzomib using a noncompartmental method.|Cycle 1, Day 1 before dosing, at the end of the injection, 5, 15, 30, and 60 minutes, and 1.5, 2, 4, 6 and 24 hours postdose.|"The pharmacokinetic (PK) evaluable population includes participants with stable baseline renal function (Arms 1–4) who completed all protocol-specified treatment and PK blood sample collection through Cycle 1, Day 16. In Group 5, only samples collected before dialysis were included.~CL could not be estimated for 11 patients in the PK population."|||liters/hour||Standard Deviation|Mean
1467907|NCT00721630|Secondary|Number of Participants With Toxicities Associated With Capecitabine and Lapatinib|Toxicities evaluated according to NCI CTC v.3|6 months||||Participants|||Count of Participants
1467908|NCT00721630|Primary|Estimate Efficacy of Capecitabine 7/7 in Combination With Lapatinib in Patients With HER2 Overexpressed/Amplified, Trastuzumab-refractory, Metastatic Breast Cancer as Determined by Overall Response Rate (Complete Response (CR) + Partial Response (PR))|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|6 months||||Participants|||Count of Participants
1467909|NCT00721617|Secondary|C-peptides Levels for Intralipid/Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1467910|NCT00721617|Secondary|C-peptides Levels for Dextrose Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1467911|NCT00721617|Secondary|C-peptides Levels for Intralipid Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after Intralipid infusion, and 8 hours after Intralipid infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1467912|NCT00721617|Secondary|C-peptides Levels for Saline Infusion|"Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.~A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin."|Baseline, 4 hours, 8 hours||||ng/mL||Standard Deviation|Mean
1467913|NCT00721617|Secondary|Insulin Levels for Intralipid/Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1467914|NCT00721617|Secondary|Insulin Levels for Dextrose Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1467915|NCT00721617|Secondary|Insulin Levels for Intralipid Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1467916|NCT00721617|Secondary|Insulin Levels for Saline Infusion|Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.|Baseline, 4 hours, 8 hours||||μU/mL||Standard Deviation|Mean
1467917|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid/Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1467918|NCT00721617|Secondary|Plasma Glucose Levels for Dextrose Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1467919|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 8 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 8 hours||||mmHg||Standard Deviation|Mean
1467920|NCT00721617|Primary|Change in Diastolic Blood Pressure From Baseline to 4 Hours|Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 4 hours||||mmHg||Standard Deviation|Mean
1467921|NCT00721617|Secondary|Plasma Glucose Levels for Intralipid Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1467922|NCT00721617|Secondary|Plasma Glucose Levels for Saline Infusion|Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.|Baseline, 4 hours, 8 hours||||mg/dL||Standard Deviation|Mean
1467923|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 8 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.|Baseline, 8 hours||||mg/dL||Standard Deviation|Mean
1467924|NCT00721617|Secondary|Change in Triglyceride Levels From Baseline to 4 Hours|Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.|Baseline, 4 hours||||mg/dL||Standard Error|Mean
1467925|NCT00721617|Secondary|Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.|Baseline, 8 hours||||mmol/L||Standard Deviation|Mean
1467926|NCT00721617|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours|Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.|Baseline, 4 hours||||mmol/L||Standard Deviation|Mean
1467927|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 8 Hours|Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 8 hours||||mmHg||Standard Error|Mean
1467928|NCT00721617|Primary|Change in Systolic Blood Pressure From Baseline to 4 Hours|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.|Baseline, 4 hours||||mmHg||Standard Error|Mean
1467929|NCT00721617|Primary|Change in Flow-mediated Dilation From Baseline to 4 Hours|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.|Baseline, 4 hours||||percent change in diameter||Standard Deviation|Mean
1467930|NCT00721578|Secondary|Medication Administration|Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration.|Up to 9 months|FAS.|||Participants|||Number
1467931|NCT00721578|Secondary|Median Duration of Antifungal Therapy||Up to 9 months|FAS.|||Days||Full Range|Median
1467932|NCT00721578|Secondary|Concomitant Medications||Up to 9 months|FAS.|||Participants|||Number
1467933|NCT00721578|Primary|Number of Participants With Mycological Outcomes|"Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy~), or unknown (results are not available/not known) as assessed by the Investigator/Physician."|Up to 9 months|FAS.|||Participants|||Number
1467934|NCT00721578|Primary|Number of Participants With Clinical Outcomes.|"Clinical outcomes, as assessed by the investigator, defined as:~Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period.~Deteriorated: clinical signs and symptoms of fungal infection worsened (including death).~Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation."|Up to 9 months|FAS.|||Participants|||Number
1467935|NCT00721578|Primary|Total Daily Dose for Selected Antifungal Agent||Up to 9 months|FAS. Data were not analyzed.|||mg|||Number
1467936|NCT00721578|Primary|Management of SFI: Reason for Selection of Antifungal Agent|Number of participants with reason for investigator's selection of particular antifungal therapy.|Up to 9 months|FAS. Data were not analyzed.|||Participants|||Number
1467937|NCT00721578|Primary|Management of SFI: Choice of Treatment|Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.|Up to 9 months|FAS.|||Participants|||Number
1467938|NCT00721578|Primary|Diagnosis of Systemic Fungal Infection (SFI)|Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.|Up to 9 months|Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment|||Participants|||Number
1467939|NCT00721539|Secondary|Average Operative Time|Average operative time in minutes|Up to four hours (240 minutes)|Participants|||Minutes||Full Range|Mean
1467940|NCT00721539|Secondary|Average Blood Loss|Blood lost during procedure|Duration of procedure up to two hours|Participants|||mL||Full Range|Mean
1467941|NCT00721539|Secondary|Feasibility Defined as Ability to Perform the Planned Diagnostic or Therapeutic Procedure||Six weeks|Adult patients 18 years of age and over|||Participants|||Number
1467942|NCT00721539|Primary|Overall Complication Rate (Intraoperative and Postoperative)|Complications encountered intraoperatively or up to six weeks postoperatively. This would include injury to patient, hemorrhage, lacerations, and readmission following surgery.|Six weeks|Subjects enrolled in this pilot study.|||Participants|||Number
1467943|NCT00721500|Primary|Lens Tightness on Cornea With Manual Digit Push Up|Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||percentage|Participants|Standard Deviation|Mean
1467944|NCT00721500|Primary|Lens Fit Decentration|Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||mm|Participants|Standard Deviation|Mean
1467945|NCT00721500|Primary|Proportion of Eyes Successfully Fit|Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.|Within 20 minutes of lens insertion|Participants who were enrolled and completed the study.|||proportion of participant eyes|Participants||Number
1467996|NCT00721253|Primary|Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate|Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.|6 months||||logMAR||Standard Deviation|Mean
1467946|NCT00721409|Secondary|Number of Participants With Treatment-Related Adverse Events at Phase 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 41 months)|As treated set included all treated participants classified by the treatment actually received.|||Participants|||Number
1467947|NCT00721409|Secondary|Number of Participants With TEAEs (All Causalities) at Phase 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent adverse events were those with initial onset or that worsen in severity after the first dose of study medication.|Maximum treatment duration (approximately 41 months)|As treated set included all treated participants classified by the treatment actually received.|||Participants|||Number
1467948|NCT00721409|Secondary|Percentage of Participants With Tumor Expression of CYP19A1 and CCND1 Genotypes at Phase 2|One 2-mL blood specimen was collected for the analysis of germline polymorphism in CYP19A1 and CCND1 genes. A single nucleotide polymorphism (SNP) rs4646 as defined in the National Center for Biotechnology Information (NCBI) database in the aromatase gene (CYP19A1) was analyzed. A germline polymorphism G/A870 (rs9344) in the CCND1 gene was analyzed.|Screening visit (≤ 28 Days prior to dosing)|Polymorphism analysis set included participants in the safety analysis set who had at least 1 polymorphism assessment.|||Percentage of participants|||Number
1467949|NCT00721409|Secondary|Summary of Copy Number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) at Phase 2|Gene copy number for CCND1 (CCND1/CEP11) and p16/INK4A (p16/CEP9) were evaluated. This analysis was done for Phase 2 combined group.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.|||Copy number||Standard Deviation|Mean
1467950|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Tumor Retinoblastoma (RB) and CyclinD1|Presence or absence of tumor RB and CyclinD1 were evaluated. The following definitions of expression applied in the below table: Positive: any expression >0 and Negative: any expression=0.|Screening visit (≤ 28 Days prior to dosing)|Protein biomarkers analysis set included all participants in the safety analysis set who had at least protein biomarker assessment.|||Participants|||Number
1467951|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - Ki67|Frequency of tumor tissue biomarker Ki67 was evaluated in across treatment groups.|Screening visit (≤ 28 Days prior to dosing)|All participants in the Safety Analysis set who had a Ki67 protein biomarker assessment.|||Participants|||Number
1467952|NCT00721409|Secondary|Presence or Absence of Tumor Tissue Biomarkers at Phase 2 - p16/INK4A, CCND1|Tissue samples were used for retrospective biomarker analyses. For Phase 2 Part 2, the tissue samples were sent to a central laboratory for the assessment of participant selection biomarkers. For Phase 2 Part 1, the assessment of the biomarkers (CCND1 amplification and/or loss of p16) were performed retrospectively from the available samples.|Screening visit (≤ 28 Days prior to dosing)|Copy number analysis set included participants in the Safety Analysis Set who had at least 1 of the biomarker assessments.|||Participants|||Number
1467953|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Interference Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.|||Units on a scale||Standard Error|Mean
1467954|NCT00721409|Secondary|Change From Baseline in Modified Brief Pain Inventory in Pain Severity Scale (mBPI-sf) Questionnaire at Phase 2|The mBPI-sf is a validated and reliable self-report questionnaire which consists of 13 questions that assess the severity and impact of pain on daily function. The 13 items of the questionnaire make up two scales and two single items. The scales include the 4-item Pain Severity Scale (worst pain, least pain, average pain, and pain right now) and the 7-item Pain Interference Scale (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item of the pain severity and pain interference scales are based on a 11-point numeric rating scale from 0 (“no pain” or “does not interfere”) to 10 (“pain as bad as you can imagine” or “completely interferes”).|Baseline, End of treatment (approximately 41 months)|Patient reported outcome evaluable participants included participants who had received at least 1 dose of study medication, had baseline data, and at least one post-baseline measurement.|||Units on a scale||Standard Error|Mean
1467955|NCT00721409|Secondary|Time to Tumor Progression (TTP) at Phase 2-Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1468013|NCT00721188|Secondary|Total Body Clearance (Cl)|Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)|Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.||||dL/hour||Standard Deviation|Mean
1467956|NCT00721409|Secondary|Number of Participants With CBR at Phase 2 - Investigator Assessment|CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized patients from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Percentage of participants||95% Confidence Interval|Number
1467957|NCT00721409|Secondary|Duration of Response at Phase 2 - Investigator Assessment|Time in weeks, (months or years) from randomization or (start of study treatment for non-randomized studies) to first documentation of objective tumor progression. TTP was calculated as (first event date or last known progression-free date minus the date of randomization [or first dose of study medication for non-randomized studies] plus 1) divided by 7 or 30.44 if in months. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD] per RECIST).|From randomization up to the end of treatment (approximately 41 months)|A subset of ITT population i.e., participants who had response was used for this analysis.|||Months||95% Confidence Interval|Median
1467958|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response in Participants With Measurable Disease at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions. Measurable disease referred to the lesions that was accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10-16 mm with spiral computer tomography scan (depending on reconstruction interval). Clinical lesions were only be considered measurable when they were superficial (eg, skin nodules, palpable lymph nodes).|From randomization up to the end of treatment (approximately 41 months)|Participants in ITT population with measurable disease were used.|||Percentage of participants||95% Confidence Interval|Number
1467959|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Response at Phase 2- Investigator Assessment|Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From randomization up to the end of treatment (approximately 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Percentage of participants||95% Confidence Interval|Number
1467960|NCT00721409|Secondary|Overall Survival (OS) at Phase 2|Time in weeks or months from randomization to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization plus 1) divided by 7 or 30.44 if in months.|From randomization until death (assessed up to 41 months)|ITT was used. This represented all randomized participants from Ph2P1or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1467961|NCT00721409|Secondary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval at Phase 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia’s formula (QTcF = QT divided by cube root of RR), by Bazette’s formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|Cycle 1 Day 1 prior to dosing, Cycle 1 Day 14 (2, 4 [prior to meal], 8, 24, 48, and 96 hours after dosing of Palbociclib), Cycle 2 Day 1 and Day 14 (prior to and 4 hours after dosing of letrozole)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1467962|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Tmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Full Range|Median
1467963|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: Cmax at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, and Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467997|NCT00721227|Secondary|Weight Loss Following Reduction Gastroplasty|Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.|12 months|Includes only participants who completed month 12 visit.|||Percentage of weight loss||Standard Deviation|Mean
1467964|NCT00721409|Secondary|Summary of Plasma Letrozole Pharmacokinetic Parameter Following Letrozole Alone and in Combination With Palbociclib: AUC24 at Phase 1|On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing. On Cycle 2 Day 28, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, and 24 hours after letrozole dosing.|Cycle 2 Day 14, Cycle 2 Day 28|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1467965|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Volume of Distribution (Vz/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||L||Geometric Coefficient of Variation|Geometric Mean
1467966|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Apparent Clearance (CL/F) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1467967|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Terminal Plasma Half-life (t1/2) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Standard Deviation|Mean
1467968|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Time to Maximum Plasma Concentration (Tmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||Hour||Full Range|Median
1467969|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Maximum Observed Plasma Concentration (Cmax) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1467970|NCT00721409|Secondary|Summary of Plasma Palbociclib Steady-state Pharmacokinetic Parameter Following Palbociclib Alone and in Combination With Letrozole: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) at Phase 1|On Cycle 1 Day 14, plasma pharmacokinetic samples were collected prior to and 1, 2, 4, 8, 12, 24, 48, 96 and 120 hours after Palbociclib dosing. On Cycle 2 Day 14, plasma pharmacokinetic samples for Palbociclib and letrozole were collected prior to and 1, 2, 4, 8, 12 and 24 hours after Palbociclib and letrozole dosing.|Cycle 1 Day 14, and Cycle 2 Day 14|The pharmacokinetic concentration set included all participants who were treated and had at least 1 concentration measurement in at least 1 pharmacokinetic assessment day. The pharmacokinetic parameter analysis set consisted of all participants treated who had at least 1 of the pharmacokinetic parameters of primary interest.|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
1467971|NCT00721409|Secondary|Percentage of Participants With Clinical Benefit Response (CBR) at Phase 1|CBR is defined as a confirmed CR, confirmed PR, or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging >= 4 weeks after initial response.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.|||Percentage of participants||95% Confidence Interval|Number
1467998|NCT00721227|Secondary|Durability of Gastric Plications Following Reduction Gastroplasty|The number of participants who completed month 12 gastroscopies showing intact plications.|12 month|Includes only participants who completed month 12 gastroscopy.|||participants|||Number
1467999|NCT00721227|Primary|Successful Gastric Plication Using Reduction Gastroplasty|The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.|Immediately post-operative||||participants|||Number
1467972|NCT00721409|Secondary|Objective Response Rate - Percentage of Participants With Confirmed Objective Tumor Response at Phase 1|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as ≥30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.|From Baseline up to end of study (assessed up to 55 months)|Efficacy analysis set included all enrolled participants with the disease under study, adequate baseline disease assessment, and who started study treatment.|||Percentage of participants||95% Confidence Interval|Number
1467973|NCT00721409|Primary|Progression-Free Survival (PFS) at Phase 2 - Investigator Assessment|PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Weeks or Months) = (first event date minus randomization or the first dose date plus 1) divided by 7 (or 30.44 if in months). PFS is usually characterized by the median, 25% percentile,75% percentile and their 95% Confidence Intervals (CIs).|From randomization date to date of first documentation of progression or death (assessed up to 41 months)|Intent-to-Treat (ITT) was used. This represented all randomized participants from Ph2P1 or Ph2P2 or Ph2P1+Ph2P2, where participants were classified according to the randomized treatment regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
1467974|NCT00721409|Primary|Number of Participants With Dose Limiting Toxicities at Phase 1|Dose limiting toxicity was defined as any of the following TEAEs occurring during the second cycle of treatment and possibly attributable to the combination of letrozole plus Palbociclib: 1. Grade 4 hematologic toxicity (including platelets <25,000/μL, ANC <500/μL). 2. Grade 3 neutropenia associated with a documented infection or fever ≥38.5°C. 3. Grade ≥3 non-hematologic toxicities, except those that have not been maximally treated (eg, nausea, vomiting, diarrhea, hypertension). 4. Delay by ≥1 week in receiving the next scheduled dose of either study treatment due to persisting treatment-related toxicities (platelet count <50,000/μL; ANC <1,000/μL; nonhematologic toxicities of Grade ≥3 severity). 5. Inability to deliver at least 80% of the planned Palbociclib or letrozole doses during Cycle 2 due to toxicity possibly attributable to the study treatment.|Cycle 2 (4 weeks)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1467975|NCT00721409|Primary|Number of Participants With Treatment-Related Adverse Events at Phase 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1467976|NCT00721409|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) at Phase 1|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Maximum treatment duration (approximately 55 months)|Safety analysis set included all participants who received at least 1 dose of any agent of the combination.|||Participants|||Number
1467977|NCT00721396|Secondary|Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.|"Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.~Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies."|1 month after 3rd vaccination||||Percentages of subjects||95% Confidence Interval|Number
1467978|NCT00721396|Secondary|Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|One month after third Men B vaccination|PP Population|||Percentages of subjects||95% Confidence Interval|Number
1467979|NCT00721396|Secondary|Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.|The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.|One month after third Men B vaccination|PP Population|||Percentages of subjects||95% Confidence Interval|Number
1467980|NCT00721396|Secondary|Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|one month after third Men B vaccination|PP Population|||Ratio||95% Confidence Interval|Geometric Mean
1467981|NCT00721396|Secondary|Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.|The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.|One month after third Men B vaccination|PP Population|||Titers||95% Confidence Interval|Geometric Mean
1467982|NCT00721396|Secondary|Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine|Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.|One month after 3rd vaccination|All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to analysis: Per Protocol (PP) Population.|||Percentages of subjects||95% Confidence Interval|Number
1467983|NCT00721396|Secondary|Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age|The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.|One month after 3rd Men B vaccination|Analysis was done on the per-protocol population i.e all subjects in the MITT population who received all the relevant doses of vaccine correctly, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
1467984|NCT00721396|Primary|Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age|Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).|10 months (groups 1 and 2); 8 months (groups 3 and 4)|All subjects receiving at least one injection and providing post-baseline safety data (Safety Set).|||Number of subjects|||Number
1467985|NCT00721396|Primary|Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine|"The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.~The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).~The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains."|One month after third Men B vaccination|The analysis was done on the Modified Intention to Treat (MIIT) population, ie, enrolled subjects who actually received a study vaccination and provided at least one evaluable serum sample after baseline.|||Percentages of subjects||95% Confidence Interval|Number
1467986|NCT00721357|Secondary|Magnetic Resonance Spectroscopy of Muscle Metabolic Properties||within one week of enrollment|||||||
1467987|NCT00721357|Secondary|Muscle Mechanical Energy Expenditure|mechanical work done by lower extremity joints|one time measure||2015-12-31|12/2015||||
1467988|NCT00721357|Primary|Oxygen Consumption During Walking|Amount of oxygen consumed during walking at self-selected speed normalized to speed|within one week of enrollment||||ml/kg/min||Standard Deviation|Mean
1467989|NCT00721279|Primary|Correlation of the Change in IRLS at End of Titration and at Final Visit|Correlation of the change in IRLS at end of titration and at final visit|Up to 12 weeks|Full Analysis Set (FAS)|||percentage of patients|||Number
1467990|NCT00721279|Primary|Frequency of Adverse Events|Frequency of patients with any adverse event, causally related adverse events and serious adverse events|Up to 16 weeks|Safety Analysis Set (SAF)|||participants|||Number
1467991|NCT00721279|Primary|Change in Global Clinical Impression - Improvement (CGI-I) Scale|The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient’s illness has improved or worsened relative to a baseline state. A patient’s illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse|baseline and final visit (week 12)|Full analysis set|||percentage of participants|||Number
1467992|NCT00721279|Primary|Change in Total Scores of IRLS (International Restless Legs Rating Scale)|"The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.~The change from baseline was calculated as baseline minus the week 12 value."|Baseline and final visit (week12)|Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included|||scores on a scale||Inter-Quartile Range|Median
1467993|NCT00721279|Primary|Frequency Analysis for Baseline Pattern of RLS Symptoms|Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.|Baseline|Full analysis set (FAS)|||percentage of participants|||Number
1467994|NCT00721253|Secondary|Defocus Curve|Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months post-operative||||logMAR||Standard Deviation|Mean
1467995|NCT00721253|Secondary|Contrast Sensitivity|Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.|6 months||||log units||Standard Deviation|Mean
1468011|NCT00721188|Secondary|Volume of Distribution Based on the Terminal Phase (Vdarea)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
1468000|NCT00721214|Secondary|Two-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with two year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two- year event-free survival rate is the same as for overall survival, 37% (SE = 14.3%).|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1468001|NCT00721214|Secondary|One-year Event-free Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants with one year event free survival after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated one-year event-free survival rate is the same as for overall survival, 47% (SE = 13.6%).|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1468002|NCT00721214|Secondary|Two-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts.|Percentage of participants alive two years after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored.The estimated two year survival rate is 37% .The estimated two-year overall survival rate is the same as two-year event free survival.|2 years|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1468003|NCT00721214|Primary|Two Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival. The percentage of patients was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated two-year event-free survival rate is the same as overall survival, 50%.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1468004|NCT00721214|Primary|One Year Event Free Survival (EFS) for Allogeneic Transplant Recipients After Transplantation|Percentage of participants that received allogeneic transplant and had event free survival, as estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. The estimated one-year event-free survival rate is the same as overall survival, 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1468005|NCT00721214|Primary|Two Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive two years after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated two year survival rate is 50%, the same as one year survival rate.|2 years|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1468006|NCT00721214|Secondary|One-year Overall Survival From Time of Treatment Initiation With 5-Azacytidine for All Study Cohorts|Percentage of participants alive one year after their first treatment was estimated by the Kaplan-Meier survival curve. The events analyzed are evidence of molecular, cytogenetic or histologic relapse or death from any cause. Patients alive at the time of last observation will be censored. The estimated one year overall survival rate from this curve is 47%. The one year overall survival is the same as one year event free survival rate.|1 year|Intent to treat analysis including patients who consented and were eligible. Patients enrolled in the study having received at least one 28 day cycle of 5-Azacytidine. As well as engraftment of white blood cells and platelets, graft failure, relapse and Graft Versus Host Disease (GVHD) will be considered in the intent-to-treat analysis.|||percentage of participants||95% Confidence Interval|Number
1468007|NCT00721214|Primary|One Year Overall Survival of Allogeneic Transplant Recipients After Transplantation|Percentage of patients alive one year after their transplantation, as estimated by the Kaplan-Meier survival curve. The estimated one year survival rate from this curve is 50%, while the estimated two year survival rate is 50%.|1 year|Patients surviving after stem cell infusion will be considered in the transplantation cohort; those dying or relapsing prior to this event are considered to have progressed. Outcomes of 5-Axacytidine responders and non-responders will be compared. Patients alive at the time of last observation will be censored.|||percentage of participants||95% Confidence Interval|Number
1468008|NCT00721188|Secondary|Number of Participants With Serious Adverse Events (SAE's)||Day of initial treatment with Venofer through 30 days after study treatment||||participants|||Number
1468009|NCT00721188|Secondary|Mean Residence Time (MRtime)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
1468010|NCT00721188|Secondary|Volume of Distribution at Steady State (Vdss)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||dL||Standard Deviation|Mean
1468016|NCT00721188|Primary|Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug*hr/dL||Standard Deviation|Mean
1468017|NCT00721188|Primary|Serum Terminal Phase Elimination Half-life (T1/2)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
1468018|NCT00721188|Primary|Time to Maximum Serum Concentration (Tmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||hour||Standard Deviation|Mean
1468019|NCT00721188|Primary|Maximum Observed Serum Concentration (Cmax)||Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.||||ug/dL||Standard Deviation|Mean
1468020|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.|at 2 weeks and 4 weeks after stent insertion|91 participants who had successful stent insertion were analyzed based on per protocol analysis.|||proportion of participants||95% Confidence Interval|Mean
1468021|NCT00721175|Secondary|Cost Effective Ratio of Metallic and Plastic Stent|cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature|until the patients expire (Markov model)|Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma|||cost (US$) per QALY|||Number
1468022|NCT00721175|Secondary|Patients Survival Times|survival times of the patients after the first stent insertion|until patient died or 6 months after the last patient was enrolled||||days||Inter-Quartile Range|Median
1468023|NCT00721175|Primary|Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)|Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.|at 2 weeks and 4 weeks after stent insertion|All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)|||proportion of participants||95% Confidence Interval|Mean
1468024|NCT00721162|Secondary|Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events|Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|First dose to 30 months|All participants who received any amount of study drug.|||participants|||Number
1468025|NCT00721162|Secondary|Overall Survival (OS)|Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.|First dose to death due to any cause up to 43.9 months|All participants who received any amount of study drug. The number of participants censored was 12.|||months||95% Confidence Interval|Median
1468026|NCT00721162|Secondary|Overall Survival at 1 Year (OS-1)|Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.|First dose to 12 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1468027|NCT00721162|Secondary|Progression-Free Survival (PFS)|Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.|First dose to measured progressive disease or death due to any cause up to 34.6 months|All participants who received any amount of study drug. The number of participants censored was 11.|||months||95% Confidence Interval|Median
1468028|NCT00721162|Primary|Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)|Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.|First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1468029|NCT00721162|Primary|Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)|Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.|First Dose to 6 Months|All participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
1468030|NCT00721149|Secondary|Percentage of Subjects Who Responded to Quality of Life Assessment|SF 36 Symptom Frequency and Severity Checklist|1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
1468031|NCT00721149|Secondary|TTM Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
1468032|NCT00721149|Secondary|24-hour Holter Data||1 year|Data not analyzed due to study termination – insufficient data to identify meaningful differences and draw significant conclusions.||||||
1468033|NCT00721149|Secondary|Percentage of Subjects Who Achieved Acute Success|Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.|Day 91 - 361|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
1468034|NCT00721149|Primary|The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.|Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.|within 7 days of ablation procedure|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
1468035|NCT00721149|Primary|Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.|A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).|From study day 91 through day 361|The subjects who had a study ablation procedure.|||Percentage of participants|||Number
1468036|NCT00721136|Primary|Anticoagulant Related Complications|Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia|30 days||||participants|||Number
1468037|NCT00721136|Primary|Thromboembolic Events||30 days||||participants|||Number
1468038|NCT00721136|Primary|Bleeding Complication|Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.|30 days|Baseline characteristics of both groups were well matched except that patients randomized to warfarin discontinuation were more obese (P = .024).|||participants|||Number
1468039|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Using the 36-Item Short-Form Health Survey (SF-36) Over Time, Through 264 Weeks|The SF-36 Health Survey is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL. The percentage of participants with at least a 5-point improvement from baseline is presented for each subscale.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Percentage of Participants|||Number
1468040|NCT00721123|Secondary|Percentage of Participants With at Least a 5-point Improvement From Baseline in Quality of Life Measure for Fatigue Over Time, Through 264 Weeks|"Quality of life is measured using the sub-scale for Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F). The assessment was originally developed for chronic illnesses and is now widely used for patients with rheumatoid arthritis.~FACIT-F is a 13-item questionnaire. Participants score each item on a 5-point scale: 0 (Not at all) to 4 (Very much), for a highest possible score of 52. The responses are transformed into a FACIT-F score, where a higher score reflects an improvement. The percentage of participants with at least a 5-point improvement from baseline in the Facit-F score is shown at categorical time points."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Percentage of Participants|||Number
1468041|NCT00721123|Primary|Overall Death Rate Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1.~To calculate the death rate, the total cumulative number of years that all participants were exposed to the drug, from first active drug intake to last safety assessment available + 1, was calculated as 2461.94. Since 10 participants died during that time, the death rate per year was not informative (0.00). Therefore, the overall death rate was calculated with the confidence interval based on events per 100 patient years exposure."|through 264 Weeks|All exposure population, which included all participants who entered the study and received at least one dose of tocilizumab at any time.|||Deaths per 100 PY||95% Confidence Interval|Number
1468042|NCT00721123|Primary|Summary Adverse Event Rates Over Time|"Patient year (PY) refers to duration in study, calculated from first active drug intake to last safety assessment available + 1. Patient year rates with confidence interval were calculated for adverse events of interest in evaluating the long-term safety of the product being studied.~Abbreviations include the following: adverse event (AE), adverse event of special interest (AESI), gastrointestinal (GI), serious adverse event (SAE), and investigational product (IP). Hypersensitivity events were defined as AEs that occurred during or within 24 hours of IP infusion and were not deemed “unrelated” to trial treatment by the investigator. This definition includes all types of AEs, regardless of whether or not they were consistent with hypersensitivity.~Medical confirmation of the AESI GI perforation was based on medical adjudication of events captured by the GI Perforation Standardised MedDRA Queries (SMQs)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Adverse Events per 100 Patient Years||95% Confidence Interval|Number
1468043|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Level of Pain Over Time, Through 264 Weeks|The patient’s assessment of the patient's current level of pain on a 100 mm horizontal VAS was recorded. The extreme left end of the line was described as “no pain” and the extreme right end as “unbearable pain”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1468044|NCT00721123|Secondary|Change From Baseline in Scores for Physician's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Physician’s global assessment of disease activity is the treating physician’s assessment of the patient’s current disease activity on a 100 mm horizontal visual analogue scale (VAS). The extreme left end of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the extreme right end as “maximum disease activity”. Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1468045|NCT00721123|Secondary|Change From Baseline in Scores for Patient's Global Assessment of Disease Activity Over Time, Through 264 Weeks|Patient’s global assessment of disease activity is the patient’s overall assessment of their disease activity during specified time periods on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme as “maximum disease activity” (maximum arthritis disease activity). Change from baseline was calculated for given periods, and a negative change indicates improvement.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1468046|NCT00721123|Secondary|Change From Baseline in Scores for Health Assessment Questionnaire − Disability Index Over Time, Through 264 Weeks|"The Stanford Health Assessment Questionnaire - Disability Index (HAQ-DI) is a questionnaire specific for rheumatoid arthritis with 8 component sets (domains): dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has 2-3 questions (for a total of 20) that participants answer with categorical answers enumerated as a scale of 0-3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do.~To calculate the HAQ-DI the patient must have a domain score for at least 6 of the eight domains. The HAQ-DI is the sum of the domain scores, divided by the number of domains that have a score (in range 6-8). The resulting HAQ-DI scores are on a scale that ranges from 0 to 3, where 0=lowest level of difficulty and 3=highest level of difficulty. A negative change from baseline indicates improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Units on a Scale||Standard Deviation|Mean
1468047|NCT00721123|Secondary|Change From Baseline in Scores for Swollen and Tender Joint Counts Over Time, Through 264 Weeks|"Swollen joint count (SJC) includes an assessment of 66 joints, and tender joint count (TJC) include an assessment of 68 joints. Joint prosthesis, arthrodesis or fused joints were not considered. Joints were assessed and classified as swollen/not swollen, and tender/not tender, by pressure and joint manipulation on physical examination. Change from Baseline in the SJC and TJC were calculated at given time points, and a negative change indicates improvement.~A small proportion of participants in the all-exposure population reduced or stopped their oral corticosteroid use due to sustained efficacy (defined as at least a 50% improvement in both swollen joint count (SJC) and tender joint count (TJC)."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time, with a score at the given time point.|||Joints||Standard Deviation|Mean
1468048|NCT00721123|Secondary|Percentage of Participants Classified as Responders by EULAR Response Over Time, Through 264 Weeks|Participants were classified as responders based on a European League Against Rheumatism (EULAR) response of Good or Moderate. Comparing the DAS28 from one patient on two different time points, it is possible to define improvement or response. The EULAR response criteria take into consideration both the first score and the change in score in order to classify them as good response, moderate response or no response. The percentage of participants who were classified as responders was recorded, as posted below.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Percentage of Participants|||Number
1468049|NCT00721123|Secondary|Percentage of Participants Classified as Responders by Disease Activity Scores Over Time, Through 264 Weeks|The disease activity score 28 (DAS28) is a combined index for measuring disease activity in rheumatic arthritis (RA) that includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The DAS28 scale ranges from 0 to 10, where lower scores represent less disease activity. Participants with DAS28 scores less than 2.6 were categorized as responders with remission and those with DAS 28 scores of 3.2 or less were categorized as responders with low disease activity (LDA). The percentage of participants classified as responders in each category was recorded over time.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Percentage of Participants|||Number
1468050|NCT00721123|Secondary|Participants Showing Improvement in Rheumatoid Arthritis Symptoms Over Time, Through 264 Weeks|"The American College of Rheumatology (ACR) established certain criteria to measure improvement in rheumatoid arthritis symptoms that include tender or swollen joint counts and five other criteria, including acute phase reactant, patient assessment, physician assessment, pain scale, and disability/functional questionnaire.~Clinical trials use the ACR Score, based on those criteria, as a standard for reporting different degrees of improvement in rheumatoid arthritis symptoms.~Scores on the ACR scale may be up to ACR100 because the number after “ACR” is the percent of improvement in tender or swollen joint counts as well as in three of the other five criteria. Clinical trials determine the percentage of participants who achieve that score – that percentage of improvement."|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab, with a score at the given time point.|||Percentage of Participants|||Number
1468051|NCT00721123|Primary|Adverse Event (AE) Summary Over Time|The number of participants experiencing at least one adverse event (AE) is recorded for each 12-month time period, with multiple occurrences in a single individual counted. Because months were calculated as 28 days, the periods actually equate to 48 weeks.|through 264 Weeks|All exposure population, which includes all participants who entered the study and received at least one dose of tocilizumab at any time.|||Participants|||Number
1468158|NCT00720330|Secondary|Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents|The cumulative opioid consumption is calculated as fentanyl equivalent|From admission to the end of surgery||||mcg||Standard Deviation|Mean
1468052|NCT00721110|Secondary|Verbal Response Fatigue Score on Postoperative Day 1|Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.|postoperative day 1|11 patients had missing POD 1 fatigue scores (e.g., 11 for lidocaine vs. nonlidocaine and 11 for ketamine vs. nonketamine).|||units on a scale||Standard Deviation|Mean
1468053|NCT00721110|Secondary|Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day||2 hours after surgery, on postoperative day 1||||percentage of participants|||Number
1468054|NCT00721110|Secondary|Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2||intraoperative through postoperative day 2||||milligram morphine sulfate equivalents||Inter-Quartile Range|Median
1468055|NCT00721110|Secondary|Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2|Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.|PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2||||units on a scale||Standard Deviation|Mean
1468056|NCT00721110|Primary|The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two|The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.|postoperative day 2||||meters||Standard Deviation|Mean
1468057|NCT00720941|Secondary|MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.|Weeks 4, 10, 16, and 22|ITT Population. Only those participants who had NSLVs, NSRVs, HHVs, and medical procedures were analyzed.|||visits||Standard Deviation|Mean
1468058|NCT00720941|Secondary|Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24|Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician’s assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.|From Day 1 up to Week 24|ITT Population. Only those participants who had non-study medical visits, telephone consulations, days in the hospital, and ER visits were analyzed.|||events per 30 days||Standard Deviation|Mean
1468059|NCT00720941|Secondary|Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The CTSQ assesses 3 domains related to the participant’s satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.|Weeks 4, 10, 16, and 22|ITT Population. Participants missing scores at early time points were excluded from the analysis at those time points. Mean total score was calculated at each assessment week.|||Scores on a scale||Standard Deviation|Mean
1468060|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1468061|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from 3 for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1468062|NCT00720941|Secondary|Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of  In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness? by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1468063|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1468064|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions (I am able to work, I am able to enjoy life, and I am content with the quality of my life now) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1468065|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions (I have nausea, I have diarrhea, and I am bothered by side effects of treatment) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1468066|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of I worry that my condition will get worse by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1468067|NCT00720941|Secondary|Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|"The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions (I have a lack of energy, I feel pain, for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition."|Baseline; Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.|||Scores on a scale||Standard Deviation|Mean
1468092|NCT00720798|Secondary|Percentage of Participants Who Withdrew From Treatment||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
1468093|NCT00720798|Primary|Percentage of Participants With ≥ 1 Adverse Event||Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
1468068|NCT00720941|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)|The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.|Baseline (predose); Weeks 4, 10, 16, and 22|ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at some of the other early time points were excluded from the analysis at those time points.|||Scores on a scale||Standard Deviation|Mean
1468069|NCT00720941|Secondary|Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)|See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.|From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)|Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.|||Participants|||Number
1468070|NCT00720941|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.|From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)|ITT Population. Only those participants who had either a confirmed CR or PR were analyzed.|||Months||95% Confidence Interval|Median
1468071|NCT00720941|Secondary|Time to Response|Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.|From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)|ITT Population. Only those participants who experienced either a confirmed CR or a PR were analyzed.|||Weeks||95% Confidence Interval|Median
1468072|NCT00720941|Secondary|Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review|The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.|From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)|ITT Population|||Participants|||Number
1468073|NCT00720941|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death (up to Study Week 268)|ITT Population. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||Months||95% Confidence Interval|Median
1468074|NCT00720941|Primary|Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.|From randomization until the earliest date of disease progression or death (up to Study Week 191)|Intent-to-Treat (ITT) Population: all participants randomized to receive treatment. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.|||Months||95% Confidence Interval|Median
1468075|NCT00720876|Secondary|Number of Participants With Grade 3 and 4 Toxicities|Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0.|3 weeks after the stop of treatment||||Participants|||Count of Participants
1468076|NCT00720876|Secondary|Progression-free Survival|Progression\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis. Estimated using the product-limit method of Kaplan and Meier.|Until disease progress\relapse, up to 1 year after the start of treatment||||Months||95% Confidence Interval|Median
1468077|NCT00720876|Primary|Overall Response Rate (Complete and Partial Response)|Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.|After every 3 cycles, up to 1 year after the start of treatment||||percentage of participants|||Number
1468078|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264|The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1468079|NCT00720798|Secondary|Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264|The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1468080|NCT00720798|Secondary|Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1468081|NCT00720798|Secondary|Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264|A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1468082|NCT00720798|Secondary|Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1468083|NCT00720798|Secondary|Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Erythrocyte sedimentation rate (ESR) was determined locally.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||mm/h||Standard Deviation|Mean
1468084|NCT00720798|Secondary|Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Units on a scale||Standard Deviation|Mean
1468110|NCT00720499|Secondary|Physician’s Global Evaluation|"Physician’s global evaluation score on days 15 and 29~The score was evaluated on a 8-points scale :~Poor : 1,2~Fair : 3,4~Good : 5,6~Excellent : 7,8~The presented means are adjusted"|Days 15 and 29|FAS|||units on a scale||Standard Error|Mean
1468085|NCT00720798|Secondary|Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264|Participant’s made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). The participant’s treating physician made a global assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). Participant’s made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated “no pain” (score = 0) and the right end of the scale indicated “unbearable pain” (score = 100).|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||mm||Standard Deviation|Mean
1468086|NCT00720798|Secondary|Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264|The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Joints||Standard Deviation|Mean
1468087|NCT00720798|Secondary|Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1468088|NCT00720798|Secondary|Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264|A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1468089|NCT00720798|Secondary|Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264|Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.|Baseline to Week 264|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.|||Percentage of participants|||Number
1468090|NCT00720798|Secondary|Percentage of Participants Who Changed From Monotherapy to Combination Therapy|Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator’s practice and as tolerated by the patient, at any time during this study.|Baseline to Week 296|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.|||Percentage of participants|||Number
1468091|NCT00720798|Secondary|Percentage of Participants With Concomitant Oral Corticosteroid Therapy|"Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count.~The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months."|Baseline to the end of the study (up to 7 years, 7 months)|All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.|||Percentage of participants|||Number
1468094|NCT00720759|Primary|Wolf Motor Function Test (Time)|The Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one’s forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task. Score range on the WMFT-T is 0-120, lower scores being better.|3 months after completion of treatment||||units on a scale||Standard Deviation|Mean
1468095|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 2|Mean terminal half-life (±SD)|Up to 205 hours|All participants|||hours||Standard Deviation|Mean
1468096|NCT00720629|Secondary|Pharmacodynamics of Visilizumab - Test 1|Mean Cmax (±SD)|At 1 - 2 hours|All participants|||ng/mL||Standard Deviation|Mean
1468097|NCT00720629|Secondary|Overall Survival (OS)|Median OS in days. Survival was measured from the time of transplant to the time of death.|At 2 years and 5 years|Participants who had died by Year 2 and additional participants who had died by Year 5.|||days||Full Range|Median
1468098|NCT00720629|Secondary|Incidence of Rituximab Response to Reactivated EBV Without PTLD|"Participants who developed plasma EBV-DNA of >1000 copies/mL on any tests received rituximab.~Incidence of Rituximab Response: Reactivated EBV participants whose plasma titers cleared after rituximab, without post-transplant lymphoproliferative disorder (PTLD)."|100 days|Reactivated EBV participants|||participants|||Number
1468099|NCT00720629|Secondary|Incidence of Epstein-Barr Virus (EBV) Reactivation|Number of participants who reactivated EBV. Patients had their plasma tested once weekly using the TaqMan polymerase chain reaction (PCR) for quantitative determination of EBV-DNA for 6 weeks. Plasma levels > 1000 copies per ml plasma were scored as positive.|3 months|All participants|||participants|||Number
1468100|NCT00720629|Primary|Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days|"Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned.~Overall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II"|100 days|All participants|||participants|||Number
1468101|NCT00720499|Secondary|AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)|"AUC (0-6h) for FEV1, and PEFR (unsupervised) after first dose and after 2 and 4 weeks of treatment were not analysed in the study report because the pertinent information from the unsupervised Pulmonary Function Tests (PFTs) was for the time interval from 6 to 12 hours post-dosing.~FVC peak 0-3h response after the first dose and at Week 2 (supervised) and AUC (6-12h) for FEV1 and PEFR after the first dose and at Week 2 (unsupervised) were not analysed in the study report.~Individual PEFR (supervised) measurements and individual FEV1 and PEFR (unsupervised) measurements at each time point were not analysed in the study report."|4 weeks|No patients analyzed in the study report.||||||
1468102|NCT00720499|Secondary|12-lead ECG QT Intervals|"12-lead ECG QT intervals baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1468103|NCT00720499|Secondary|12-lead ECG QTcB Intervals|"12-lead ECG heart rate corrected QT interval, using Bazett method (QTcB), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1468104|NCT00720499|Secondary|12-lead ECG QTcF Intervals|"12-lead ECG corrected heart rate (QT) interval, using Fridericia method (QTcF), baseline and change from baseline at other time points in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1468105|NCT00720499|Secondary|12-lead ECG QRS Intervals|"12-lead ECG QRS intervals baseline and change from baseline at other time points in milliseconds~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1468106|NCT00720499|Secondary|12-lead ECG PR Intervals|"12-lead ECG PR intervals baseline and change from baseline at other timepoints in milliseconds.~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||mS||Standard Deviation|Mean
1468107|NCT00720499|Secondary|12-lead ECG Heart Rate|"12-lead Electrocardiogram (ECG) Heart rate baseline and change from baseline values at other time points in Beats Per Minute (BPM)~Statistics for each planned time from baseline to day 29."|Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29|TS|||BPM||Standard Deviation|Mean
1468108|NCT00720499|Secondary|Overall Marked Changes From Baseline in Vital Signs|Overall marked changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline to week 14|TS|||participants|||Number
1468109|NCT00720499|Secondary|Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination|Clinically significant abnormalities for blood chemistry, haematology, urinalysis and physical examination|14 weeks|Treated Set (TS) including all randomized patients who received at least one dose of study medication.|||participants|||Number
1468111|NCT00720499|Secondary|Patient Global Rating|"Patient global rating scores treatment comparison after 4 weeks~The score was evaluated on a 7-point scale :~1 : very much better~2 : much better~3 : a little better~4 : no change~5 : a little worse~6 : much worse~7 : very much worse~The presented means are adjusted."|4 weeks|FAS|||units on a scale||Standard Error|Mean
1468112|NCT00720499|Secondary|Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])|"Weekly mean number of occasions of rescue therapy used per day (as occasion require (PRN) salbutamol [albuterol]) on weeks 1,2,3 and 4.~The means presented are the adjusted mean of weekly mean."|Weeks 1,2,3 and 4|FAS|||number of occasions / day||Standard Error|Mean
1468113|NCT00720499|Secondary|Weekly Mean Evening PEFR|"Weekly mean evening PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS|||Litres / minute||Standard Error|Mean
1468114|NCT00720499|Secondary|Weekly Mean Morning PEFR|"Weekly mean morning PEFR [L/min] on weeks 1,2,3 and 4.~The presented means are adjusted."|Weeks 1,2,3 and 4|FAS|||Litres / minute||Standard Error|Mean
1468115|NCT00720499|Secondary|PEFR AUC (6-12h) Response|"PEFR AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29|FAS|||Litres / minute||Standard Error|Mean
1468116|NCT00720499|Secondary|PEFR Peak 0-3h Response|"PEFR peak 0-3h response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres / minute||Standard Error|Mean
1468117|NCT00720499|Secondary|PEFR AUC (0-3h) Response|"Peak Expiratory Flow Rate (PEFR) AUC (0-3h) response [L/min] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres / minute||Standard Error|Mean
1468118|NCT00720499|Secondary|FVC Peak 0-3h Response|"FVC peak 0-3h response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1468119|NCT00720499|Secondary|FVC AUC (0-6h) Response|"FVC AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1468120|NCT00720499|Secondary|FVC AUC (0-3h) Response|"FVC AUC (0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
1468121|NCT00720499|Secondary|Individual FVC Measurements|"Individual FVC measurements [L] at each time point~The categories correspond to the planned times for FVC measurements on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1468122|NCT00720499|Secondary|Trough FVC Response|"Trough Forced Vital Capacity (FVC) response [L] on days 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1468123|NCT00720499|Secondary|FEV1 (Unsupervised) AUC (6-12h) Response|"FEV1 (unsupervised) AUC (6-12h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|6 hours (h), 9h and 12h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1468124|NCT00720499|Secondary|FEV1, AUC (0-6h) Response|"FEV1, AUC (0-6h) response [L] on day 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1468139|NCT00720473|Primary|Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||Mean NAA to creatine ratio||Standard Deviation|Mean
1468140|NCT00720473|Primary|Mean Glutamate to Creatine Ratio by Diagnosis at Baseline||Baseline|Baseline scans were available for 37 participants. One participant was missing scan data.|||mean serum Glutamate to Creatine ratio||Standard Deviation|Mean
1468125|NCT00720499|Secondary|FEV1 Peak 0-3h Response|"FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
1468126|NCT00720499|Secondary|FEV1 AUC 0-3h, Response|"FEV1 Area Under the Curve (AUC) 0-3h, response [L] on days 1, 15 and 29.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29|FAS|||Litres||Standard Error|Mean
1468127|NCT00720499|Secondary|Individual FEV1 Measurements|"Individual FEV1 measurements [L] at each time point on Day 29.~The presented means are adjusted."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|FAS|||Litres||Standard Error|Mean
1468128|NCT00720499|Secondary|Trough FEV1 Response [L] After 2 Weeks of Treatment|"Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15|FAS|||Litres||Standard Error|Mean
1468129|NCT00720499|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.|"Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration.~Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.~The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)."|1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29|Full analysis Set (FAS) which included all randomized patients who received at least one dose of study medication and had baseline data and Washout Period for at least 1 efficacy endpoint for each treatment period.|||Litres||Standard Error|Mean
1468130|NCT00720473|Primary|Means of MADRS Scores at 8 Weeks|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|8 Weeks|MADRS scores were available for 16 bipolar subjects who completed the protocol and 8 healthy controls.|||units on a scale||Standard Deviation|Mean
1468131|NCT00720473|Primary|Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline|The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.|Baseline|MADRS scores were available for 27 eligible bipolar subjects and 14 eligible controls.|||units on a scale||Standard Deviation|Mean
1468132|NCT00720473|Primary|Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||NAA:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
1468133|NCT00720473|Primary|Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Gln:Cr/-10 MADRS Score||95% Confidence Interval|Least Squares Mean
1468134|NCT00720473|Primary|Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up|Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. The MADRS minimum score is 0 and maximum is 60, with 60 being the most depressed score. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|8 Weeks|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Glu:Cr/-10 MADRS||95% Confidence Interval|Least Squares Mean
1468135|NCT00720473|Primary|Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks||||NAA to creatine ratio||95% Confidence Interval|Least Squares Mean
1468136|NCT00720473|Primary|Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 weeks||||serum Glutamine to Creatine ratio||95% Confidence Interval|Least Squares Mean
1468137|NCT00720473|Primary|Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up|Follow-up Least Squares Mean - Baseline Least Squares Mean|8 Weeks||||serum Glutamate to Creatine ratio||95% Confidence Interval|Least Squares Mean
1468138|NCT00720473|Primary|Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline|Estimated changes in least squares mean in the metabolite ratio per 10-point increase in MADRS score. The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.|Baseline|Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.|||Glu:Cr/+10 MADRS||95% Confidence Interval|Least Squares Mean
1468142|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.|||log10 IU/mL||Standard Deviation|Mean
1468143|NCT00720434|Secondary|Population Pharmacokinetics (PK) of PF-00868554|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28|||||||
1468144|NCT00720434|Secondary|Alanine Aminotransferase (ALT) Levels||Week 4, 12, 48, 72|FAS included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||IU/L||Standard Deviation|Mean
1468145|NCT00720434|Secondary|Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.|Week 4, 12, 48, 60, 72|Modified Analysis Set: subset of FAS that included all participants who completed the Week 4 visit.|||proportion of participants||95% Confidence Interval|Number
1468146|NCT00720434|Primary|Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set|Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.|Baseline, Week 4|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug and had both baseline and at least 1 valid post-baseline endpoint measurements for HCV viral load. Here ‘n’ signifies participants evaluable for this measure at specified time points for each arm, respectively.|||log10 IU/mL||Standard Deviation|Mean
1468147|NCT00720382|Other Pre-specified|Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|change from baseline to 12 months||||Units on a scale||Standard Deviation|Least Squares Mean
1468148|NCT00720382|Primary|Change From Baseline on Direct Visual Nasal Exams to 12 Months|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|Change from baseline to 12 months||||Participants|||Number
1468149|NCT00720369|Secondary|We Measured Response to Treatment of Depression (Using the Montgomery Asberg Depression Rating Scale)in Older Adults With Bipolar Disorder After an 8 Week Trial of CoQ10.|"The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 question questionnaire which assesses symptom severity of depression. The score is on a 0-60 scale with higher numbers indicating more severe depressive symptoms. The score is represented as a number of points.~Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group."|8 week trial|Clinical improvement following treatment with CoQ10 supplement was only tested in the Bipolar subject cohort, not in healthy controls, therefore outcome data only apply to the bipolar group.|||units on a scale||Standard Deviation|Mean
1468150|NCT00720369|Primary|We Measured the Change in Rate Constant of Creatine Kinase in Individuals With Bipolar Depression Treated With CoQ 10 as Compared With Age and Gender Matched Controls. These Rate Constants Were Calculated Using Magnetic Resonance Imaging (MRI).|The rate constant for creatine kinase is a measurement of the reaction rate ADP+PCr <---> ATP + Cr, which is catalyzed by the enzyme creatine kinase. The rate constant shows the direction and magnitude of the reaction at equilibrium. A higher rate constant indicates a higher rate constant of the CK enzyme, meaning, more efficient/rapid conversion of PCr to ATP through the creatine kinase enzymatic reaction in tissues with high and fluctuating energy demands such as brain and muscle tissue. As the value is a reaction rate, there are no associated units.|8 week trial||||per second||Standard Deviation|Mean
1468151|NCT00720343|Secondary|Prevalence of Opioid Use||24 hours after surgery|||||||
1468152|NCT00720343|Secondary|Prevalence of High Blood Choline Concentration||24 hours after surgery|||||||
1468153|NCT00720343|Secondary|Prevalence of Nausea||24 hours after surgery|||||||
1468154|NCT00720343|Primary|Prevalence of Pain||24 hours after surgery|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in March 2011.||||||
1468155|NCT00720330|Secondary|Postoperative Nausea|Number of patients who had postoperative nausea or vomiting were recorded.|After surgery until the second postoperative day.||||Participants|||Count of Participants
1468156|NCT00720330|Secondary|Pain Scores on Numerical Rating Scale|Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.|After surgery until the second postoperative mornings.||||units on a scale||Standard Deviation|Mean
1468157|NCT00720330|Secondary|Time From the End of Surgery to Readiness for Hospital Discharge.||Until hospital discharge, assessed up to 6 months||||hours||Standard Deviation|Mean
1468160|NCT00720278|Secondary|Change From Baseline on Direct Visual Nasal Exams|"Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa.~Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation"|14 days||||Participants|||Number
1468161|NCT00720278|Secondary|Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 days||||28 item/7 domain RQLQ on 0-6 scale||Standard Deviation|Least Squares Mean
1468162|NCT00720278|Secondary|Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||Reflective secondary symptom score||Standard Deviation|Least Squares Mean
1468163|NCT00720278|Secondary|Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 Days||||total nasal symptom score||Standard Deviation|Least Squares Mean
1468164|NCT00720278|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo|"rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||total nasal symptom score||Standard Deviation|Least Squares Mean
1468165|NCT00720226|Secondary|Change in FEV1 (L)|Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.|Measured at Baseline and Month 12|Participants with 5-35% emphysema at baseline who had HRCT scans performed both at baseline and at 12 months.|||L (BTPS)||Standard Deviation|Mean
1468166|NCT00720226|Primary|Change in Percent Emphysema on CT Scan|Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.|Change between baseline and month 12.|Participants with 5-35% emphysema on baseline CT scan|||% Emphysema Whole Lung||Standard Deviation|Mean
1468167|NCT00720122|Primary|Change in Spine Bone Density (g/cm^2)|Change in spine bone density over 6 months (6month data- baseline data). Bone density at the spine was assessed using dual energy x-ray absorptiometry at baseline and 6 months and the change in bone density over these 6 months was calculated.|Baseline and 6 months|The study participants analyzed were those that completed the first 6 months of the study and had a bone density performed at the baseline visit and then again at the 6 month visit as per protocol.|||gm/cm^2||Standard Error|Mean
1468168|NCT00720109|Secondary|Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)|An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.|From the time entry on study to first event or date of last follow-up, assessed up to 7 years|Included in the analysis are two patients who received the drug therapy but were not risk classified.|||percentage of patients||90% Confidence Interval|Number
1468169|NCT00720109|Secondary|Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation|A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.|At end of consolidation (at 11 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percentage of participants||90% Confidence Interval|Number
1468170|NCT00720109|Secondary|Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy|Percent of patients MRD Positive (MRD > 0.01%) at End of Induction.|At the end of induction therapy (at 5 weeks)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percentage of participants||90% Confidence Interval|Number
1468171|NCT00720109|Primary|Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events|Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)|Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)|||Pts with DLTs|||Number
1468172|NCT00720109|Primary|Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy|Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.|At 3 years|Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).|||Percent probability||90% Confidence Interval|Number
1468173|NCT00720096|Secondary|Response Rate|Determine response rate of array directed chemotherapy (as defined as the proportion of patients achieving complete or partial responses with a predictive score >/= 0.5 for either chemotherapy). As well as evaluate the accuracy of the chemosensitivity profiles for differentiating doxorubicin and topotecan responsive cancers. Due to the limited sample size the interpretation is limited. Results data for this outcome is not posted.|1 year, 2 months|Data was not collected for this Pilot study, due to small sample size and early termination.||||||
1468174|NCT00720096|Primary|Interpret Genomic Array|Number of patients with biopsiable tumor in sufficient quantity and quality that will result in an interpretable genomic array.|1 year, 2 months|All patients enrolled 4/4 had biopsiable tumor and sufficient quantity and quality.|||Participants|||Number
1468175|NCT00720096|Primary|Assess Feasibility|Number of patients meeting 3 week feasibility window which was set as the benchmark.|1 year, 2 months|Patients whose information for treatment was available within the 3 week feasibility window which was set as the benchmark.|||Participants|||Number
1468176|NCT00720083|Primary|Disease-free Survival|This study terminated early with 34 subjects accrued out of 170 planned, therefore no analyses were performed.|From randomization to date of failure (local, regional, or distant progression, or death) or last follow-up. Analysis occurs after 78 failures have been reported.|||||||
1468177|NCT00720057|Secondary|Time to Onset of Effect|"Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both perceptible and meaningful pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them."|from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours|Efficacy analyses are based on ITT population (n=312).|||hours||Full Range|Median
1468178|NCT00720057|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4).|at 24 hours postdose or immediately before first use of rescue medication|Efficacy analyses are based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1468179|NCT00720057|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication.|postdose to first use of rescue medication|Efficacy analyses are based on ITT population (n=312).|||hours||Full Range|Median
1468180|NCT00720057|Secondary|Summed Pain Intensity Difference at Specific Time Intervals|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively.|0-16 hours post dose|Efficacy analyses were based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1468181|NCT00720057|Secondary|Total Pain Relief (TOTPAR)|Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.|0-24 hours post dose|Efficacy analyses were based on ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1468182|NCT00720057|Primary|Summed Pain Intensity Difference (SPID)|Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.|0 to 24 hours post dose|Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312).|||units on a scale||Standard Deviation|Mean
1468183|NCT00719953|Primary|Improvement of Cognitive Performance (Change From Baseline in Neuropsychological Computerized Test)|The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition & recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).|Base line and 12 weeks||||Points on a scale||Standard Error|Mean
1468184|NCT00719914|Primary|Improvement in Percent Diameter Stenosis of the Culprit Artery Following the IC Bolus Administration of Eptifibatide vs. IC Placebo (Saline) as Assessed With Quantitative Coronary Angiography (QCA)||30 days|study terminated due to low enrollment||||||
1468185|NCT00719901|Secondary|Toxicity as Assessed by the National Cancer Institute (NCI) CTCAE v 3.0 (Phase II)|Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, we will review all toxicities data that is graded as 3, 4, or 5 and classified as either “unrelated or unlikely to be related” to study treatment in the event of an actual relationship developing. Adverse events and toxicities will be evaluated using all patients who have received any study treatment.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.||||||
1468186|NCT00719901|Secondary|Time to Treatment Failure (Phase II)|Time to treatment failure will be evaluated using the method of Kaplan-Meier.|Time from study entry to the date patients end treatment|No participants proceeded to Phase II for evaluation.||||||
1468187|NCT00719901|Secondary|Overall Survival (Phase II)|The distribution of overall survival will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause|No participants proceeded to Phase II for evaluation.||||||
1468188|NCT00719901|Secondary|Time to Progression (Phase II)|The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time from registration to the time of progression|No participants proceeded to Phase II for evaluation.||||||
1468271|NCT00719329|Primary|Colonization at Day 1 Swab|Was the swab collected on the day 1 visit (usually within 24 hours of birth) positive for any organism? If so, this is defined as positive.|First week of life|Intention to Treat|||Participants|||Number
1468189|NCT00719901|Secondary|Number of Patients Who Have at Least a Partial Response (Phase I)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years||||participants|||Number
1468190|NCT00719901|Primary|Proportion of Patients Who Achieve a Partial Response or Better. (Phase II)|In order to be classified as a hematologic response, confirmation of serum monoclonal protein, serum immunoglobulin free light chain (when primary determinant of response) and urine monoclonal protein (when primary determinant of response) results must be made by verification on two consecutive determinations.|From baseline to up to 3 years|No participants proceeded to Phase II for evaluation.||||||
1468191|NCT00719901|Primary|Number of Dose-limiting Toxicity (DLT) Incidents (Phase I)|DLT was defined as any events that is determined to be possibly, probably, or definitely related to the combination of bortezomib and GX15-070 (as determined by the investigator) and occurring during the first cycle of treatment, irrespective of whether the toxicity resolved. Hematologic DLT measures were assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via Common Terminology Criteria for Adverse Events (CTCAE) version 3 standard toxicity grading.|Up to 21 days of every first course||||Toxicity Incidents|||Number
1468192|NCT00719862|Secondary|Change From Baseline on Direct Visual Nasal Exams at 14 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 14 days||||Participants|||Number
1468193|NCT00719862|Secondary|Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days|"A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items."|baseline and 14 Days||||Units on a scale||Standard Deviation|Least Squares Mean
1468194|NCT00719862|Secondary|Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)|"Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days||||Refecltive secondary symptom score||Standard Deviation|Least Squares Mean
1468195|NCT00719862|Secondary|Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14-days||||total nasal symptom score||Standard Deviation|Least Squares Mean
1468196|NCT00719862|Secondary|Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo|"End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate."|baseline and 14 days||||scores on a scale||Standard Deviation|Least Squares Mean
1468197|NCT00719862|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days|"reflective total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.~Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 14 days||||scores on a scale||Standard Deviation|Least Squares Mean
1468198|NCT00719849|Secondary|Incidence of Relapse at 2 Years|"Number of participants with relapse at 2 years.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|2 years post transplant||||Participants|||Count of Participants
1468199|NCT00719849|Secondary|Incidence of Relapse at 1 Year|"Number of participants with relapse at 1 year.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated."|1 year post transplant||||Participants|||Count of Participants
1468200|NCT00719849|Secondary|Probability of Progression-free Survival at 2 Years|Kaplan-Meier estimate of the probability of progression-free survival at 2 years|2 years post transplant||||progression free survival probability||95% Confidence Interval|Number
1468201|NCT00719849|Secondary|Probability of Progression-free Survival at 1 Year|Kaplan-Meier estimate of the probability of progression-free survival at 1 year|1 year post transplant||||progression free survival probability||95% Confidence Interval|Number
1468205|NCT00719849|Secondary|Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year|"Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.~Clinical Limited cGVHD~Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.~Mild liver test abnormalities (alkaline phosphatase <2 x upper limit of normal, AST or ALT <3 x upper limit of normal and total bilirubin <1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.~Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving <20% of body surface area (BSA), dyspigmentation involving <20% BSA, or erythema involving <50% BSA, positive skin biopsy, and no other manifestations of cGVHD.~Ocular sicca (Schirmer’s test <5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.~Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD."|1 year post transplant||||Participants|||Count of Participants
1468206|NCT00719849|Secondary|Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant||||Participants|||Count of Participants
1468207|NCT00719849|Secondary|Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100|"Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)"|Day 100 post transplant||||Participants|||Count of Participants
1468208|NCT00719849|Secondary|Incidence of Platelet Engraftment at 6 Months|Number of participants with platelet engraftment at 6 months|6 months post transplant||||Participants|||Count of Participants
1468209|NCT00719849|Secondary|Incidence of Neutrophil Engraftment at Day 42|Number of participants with neutrophil engraftment at day 42|Day 42 post transplant||||Participants|||Count of Participants
1468210|NCT00719849|Secondary|Chimerism|Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.|7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant||||Participants|||Count of Participants
1468211|NCT00719849|Secondary|Incidence of Non-relapse Mortality at 6 Months|Number of Participants with Non-relapse Mortality at 6 Months|6 months post transplant||||Participants|||Count of Participants
1468212|NCT00719849|Secondary|Probability of Survival at 2 Years|Kaplan-Meier estimate of the probability of survival at 2 years|2 years post transplant||||survival probability||95% Confidence Interval|Number
1468213|NCT00719849|Primary|Probability of Survival at 1 Year|Kaplan-Meier estimate of the probability of survival at 1 year|1 year post transplant||||survival probability||95% Confidence Interval|Number
1468214|NCT00719810|Secondary|Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|Clinically Evaluable (CE) patients (see previous definition) with MRSA isolated from screening culture of primary infection.|||Participants|||Number
1468215|NCT00719810|Primary|Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.|14-21 days after the last dose of study drug|The CE population included patients with a diagnosis of cSSSI who received at least 80% of study drug, had a test of cure (TOC) visit 14-21 days after the last dose of study drug, and who did not receive any concomitant, systemic antibacterial therapy with activity against the causative pathogen.|||Participants|||Number
1468216|NCT00719732|Primary|Uncorrected Visual Acuity (UCVA)|Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity.|6 months||||logMAR||Standard Deviation|Mean
1468217|NCT00719706|Secondary|Phosphorus MRS Scans on 4T Scanner|Whole brain total NTP levels as measured by a phosphorus MRS scan on the 4T scanner. The data could range from 0 - 1, with 0 representing the lowest NTP level and 1 representing the highest NTP level.|Baseline to 12 weeks|At baseline, the number of participants analyzed was the number entered into the imaging portion of the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 10 participants in each category.|||units on a scale||Standard Deviation|Mean
1468218|NCT00719706|Primary|Clinical Global Impression-Severity|"Scores could range from 0 - 7 units on a scale, with 0 representing the least severe (Normal, not at all ill) and 7 representing the most severe (Among the most extremely ill patients)."|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1468219|NCT00719706|Primary|The Young Mania Rating Scale|The scores could range from 0 - 60 units on a scale with 0 representing the least number of manic symptoms and 60 representing the most number of manic symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1468220|NCT00719706|Primary|The Montgomery-Asberg Depression Rating Scale|Scores could range from 0 - 60 units on a scale with 0 representing the least number of depressive symptoms and 60 representing the most number of depressive symptoms.|Baseline to 15 weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1468221|NCT00719706|Primary|The 25-Item Hamilton Depression Rating Scale.|Scores could range from 0 - 72 units on a scale, with 0 representing the least number of depressive symptoms and 72 representing the most number of depressive symptoms.|Baseline to 15 Weeks|At baseline, the number of participants analyzed was the number randomized into the study. At endpoint, the number or participants analyzed is the last observation carried forward of the original 20 participants.|||units on a scale||Standard Deviation|Mean
1468222|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers|Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1468223|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters|Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.|At Week 1, and study completion (approximately 104 weeks)|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1468224|NCT00719680|Secondary|Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs|Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.|At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1468225|NCT00719680|Secondary|Number of Subjects Reporting Mild, Moderate, or Severe Local AEs|"In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of infusion site oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1468226|NCT00719680|Secondary|Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion|"The rate of AEs was the number of AEs over the number of infusions administered.~AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion."|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.|||AEs per infusion|Participants||Number
1468227|NCT00719680|Secondary|Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion|AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.|Within 24 or 72 hours after each infusion|The AT safety population comprised all subjects treated with the study medication during any study period.|||participants|||Number
1468228|NCT00719680|Secondary|Relatedness and Severity of All AEs (Percentage of Total AEs)|"At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The AT safety population comprised all subjects treated with the study medication during any study period.|||percentage of total AEs|Participants||Number
1468229|NCT00719680|Secondary|Rate of All AEs by Relatedness and Severity|"The rate of AEs was the number of AEs over the number of infusions administered.~At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to approximately 104 weeks|The All-Treated (AT) safety population comprised all subjects treated with the study medication during any study period.|||AEs per infusion|Participants||Number
1468230|NCT00719680|Secondary|Use of Antibiotics for Infection Prophylaxis and Treatment|Annualized rate of days with antibiotics for infection prophylaxis and treatment.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
1468231|NCT00719680|Secondary|Annualized Rate of Hospitalization Due to Infection|The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
1468232|NCT00719680|Secondary|Number of Days of Hospitalization Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days||Standard Deviation|Mean
1468233|NCT00719680|Secondary|Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection|The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days per subject year|Participants||Number
1468234|NCT00719680|Secondary|Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection||For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||days||Standard Deviation|Mean
1468235|NCT00719680|Secondary|Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations|Mean of individual median total IgG trough concentration.|Before infusion at Weeks 1, 24, 48, 72, and 96|The ITT population comprised all subjects treated with study medication during any study period.|||g/L||Standard Deviation|Mean
1468236|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Per-Protocol Efficacy population comprised all subjects who completed at least 48 weeks of the efficacy period that started with the first IgPro20 dose in this study.|||infections per subject year|Participants||Number
1468237|NCT00719680|Secondary|Annualized Rate of Any Infection|The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.|For the duration of the study, up to approximately 104 weeks|The ITT population comprised all subjects treated with study medication during any study period.|||infections per subject year|Participants||Number
1468238|NCT00719680|Primary|Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)|"The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.~Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess."|For the duration of the study, up to approximately 104 weeks|The Intention-to-Treat (ITT) population comprised all subjects treated with study medication during any study period.|||infections per subject year|Participants||Number
1468239|NCT00719615|Primary|Number of Persons That Are Vitamin D Deficient in the Thyroid Nodule, Thyroid Cancer in Remission, and the Active Thyroid Cancer Groups.|We evaluated serum calcium,creatinine,albumin,and 25-hydroxyvitaminD(25-OH-D)in 42 thyroid nodule, 45 thyroid cancer in remission, & 24 active thyroid cancer patients. We also determined the number and percent of participants in each group that had vitamin D deficiency, defined as 25-OH-D < 30 ng/ml.|Within 12 months of enrollment in thyroid cancer collaborative registry (TCCR) database|"This study is a pilot study to provide preliminary data. Per protocol, we accrued 37% of the sample size needed for a fully powered study. Using the outcome the proportion of persons with vitamin D deficiency, a sample size of 160 subjects (64 nodule, 64 remission, and 32 active) would achieve an 80% power to detect an effect size of 0.25."|||participants|||Number
1468240|NCT00719576|Secondary|Participants With Treatment-Emergent Adverse Events||Week 104||||Participants|||Count of Participants
1468241|NCT00719576|Secondary|Change From Baseline at Week 104 in the Remaining 3 Subscales of the KOOS Instrument (Activities of Daily Living, Knee-related Quality of Life, and Other Symptoms)|The KOOS is a validated knee-specific instrument developed to assess the patients’ opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems).|Baseline and Week 104||||units on a scale||Standard Deviation|Mean
1468242|NCT00719576|Secondary|Treatment Failure|"The planned analyses concerning time to treatment failure were not conducted due to the small number of per protocol treatment failure cases. As such, the number of participants with treatment failure is being reported.~Patients were considered as a treatment failure if all of the following 5 criteria were met:~Patient’s global assessment of their knee joint compared to Baseline was the same or worse~Physician’s global assessment of the patient’s knee joint compared to Baseline was the same, worse, or significantly worse.~Percent improvement from Baseline in KOOS Pain score was less than 10%.~Physician diagnostic evaluation of failure excluded etiologies (eg, meniscal tear) other than failed treatment of the index lesion.~The physician decided that surgical re-treatment of the index lesion(s) was required that involved either extensive debridement for lesion expansion, violation of the subchondral bone, or autologous cultured chondrocyte implantation."|Week 104||||Participants|||Count of Participants
1468243|NCT00719576|Secondary|Response Rate Based on KOOS Pain and Function (Sports and Recreational Activities) Scores at Week 104.|A responder is defined as a participant with at least a 10-point improvement in both the KOOS Pain and Function (Sports and Recreational activities) scores from Baseline|Week 104||||Participants|||Count of Participants
1468244|NCT00719576|Secondary|Assessment of Defect Fill by Magnetic Resonance Imaging (MRI)|"Number of participants with MRI degree of defect fill > 50%. Evaluation of MRI data was performed by independent central review blinded to the participant's treatment.~Appropriate MRI sequences were used to image cartilage repair tissue."|Week 104|Number of participants with MRI data at Week 104|||Participants|||Count of Participants
1468245|NCT00719576|Secondary|Histological Evaluation of Structural Repair of Evaluable Biopsies Harvested From the Core of the Index Lesion During Arthroscopy at Week 104|"The mean microscopic International Cartilage Repair Society (ICRS) II overall assessment score was used to assess the histology efficacy endpoint.~Scoring of the cartilage repair biopsies was completed using the ICRS II histology scoring system (Mainil-Varlet, 2010, Am J Sports Med) by 2 independent pathologists blinded to the patient’s assigned study treatment. This scoring system includes 14 parameters, comprising an overall assessment score reported here, as well as 13 other items related to chondrocyte phenotype, tissue structure, and other factors, each scored on a scale from 0 to 100 representing poor to good quality cartilage."|Week 104|includes all subjects with histology follow-up data|||units on a scale||Full Range|Least Squares Mean
1468268|NCT00719355|Primary|Length of Exercise Duration on the Treadmill Constant Work Rate Exercise Test|Patients walked on the CWR test at 85% of his/her peak VO2 on the baseline progressive treadmill test. Since the polewalking group was older than the walking group, subject age was entered into the analysis as a co-variate. Intent-to-treat (ITT) analyses were used. The last measurement taken for all subjects with at least one follow-up test was carried forward (n=97).|Baseline and 24 weeks|Data were analyzed on patients with at least 1 follow-up treadmill test from baseline.|||minutes||Standard Deviation|Mean
1468246|NCT00719576|Primary|Change From Baseline to Week 104 for the Participant's Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain and Function (Sports and Recreational Activities) Scores.|The KOOS is a validated knee-specific instrument developed to assess the patients’ opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL). A 5-point Likert scale was used to record the response to each item ranging from 0 (no problems) to 4 (extreme problems). Within each subscale, items were added up and normalized to a value between 0 (extreme problems) and 100 (no problems). Subscales are not combined to calculate a total score.|Baseline and Week 104|All randomized patients|||units on a scale||Standard Deviation|Mean
1468247|NCT00719563|Secondary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and Week 4|The analysis was not able to be done due to the low numbers of minorities accrued.||||||
1468248|NCT00719563|Secondary|Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.|||units on a scale||Standard Deviation|Mean
1468249|NCT00719563|Secondary|Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3|Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.|||units on a scale||Standard Deviation|Mean
1468250|NCT00719563|Secondary|Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1468251|NCT00719563|Secondary|Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1468252|NCT00719563|Secondary|Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and Week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1468253|NCT00719563|Secondary|Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.|Baseline and week 8|Includes all participants who completed both baseline and week 8 assessments.|||units on a scale||Standard Deviation|Mean
1468254|NCT00719563|Secondary|Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)|PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1468255|NCT00719563|Secondary|Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS|Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1468256|NCT00719563|Secondary|Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue|Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1468257|NCT00719563|Secondary|Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF|Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.|Baseline and Week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1468258|NCT00719563|Secondary|Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence|Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.|Week 1 to Week 8|Includes all participants that reported at least one value after baseline.|||participants|||Number
1468259|NCT00719563|Primary|Change From Baseline to Week 4 in the General Subscale of the MFSI-SF|"Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling pooped, worn out, fatigued, sluggish, run down and tired. Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4."|Baseline and week 4|Includes all participants who completed both baseline and week 4 assessments.|||units on a scale||Standard Deviation|Mean
1468260|NCT00719537|Primary|Incidence of Preeclampsia|Number of Participants with preeclampsia in second and third trimester of pregnancy.|second and third trimester of pregnancy|1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group.|||Participants|||Count of Participants
1468261|NCT00719472|Secondary|Percentage of Patients Who Had Undetectable Levels of CD19+ Lymphocytes at Cycle 2 and Either Cycle 6 or 8 (Last Cycle)|Serum samples for measurement of CD19+ lymphocytes were taken pre-dose (within 15 minutes before rituximab infusion). CD19+ lymphocyte counts were measured by flow cytometry using a fluorescent-activated cell sorter (FACS).|Day 1 of Cycle 2 and either Cycle 6 or 8 (last cycle)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1. Only patients with pre-dose CD19+ lymphocyte counts at each time point were included in the analyses.|||Percentage of participants|||Number
1468262|NCT00719472|Secondary|Maximum Serum Concentration (Cmax) of Rituximab Post-dose at the First Alternative Dosing Rate (Cycle 2) and the Last Cycle (Either Cycle 6 or 8)|Serum samples for rituximab pharmacokinetic analysis were taken pre-dose (within 15 minutes before rituximab infusion) and post-dose (within 15 minutes after the end of the rituximab infusion) after the first faster infusion (Cycle 2) and after the last infusion (either Cycle 6 or 8). An enzyme-linked immunosorbent assay (ELISA) was used to measure rituximab levels in the serum samples.|Day 1 of Cycles 2 and either 6 or 8 (last cycle)|Pharmacokinetic evaluable population: All patients who received at least 1 infusion of rituximab and had rituximab concentration data.|||µg/mL||Standard Deviation|Mean
1468263|NCT00719472|Secondary|Duration of Rituximab Infusion Including Dose Interruption Times|The median duration of the rituximab infusion on Day 1 of each cycle, including the duration of dose interruptions, is reported.|Day 1 of each of Cycles 1 to 6 or 8|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Minutes||Inter-Quartile Range|Median
1468264|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 2 Through Cycle 6 or 8 (End of Study)||Cycle 2 through Cycle 6 or 8 (end of study)|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Percentage of participants|||Number
1468265|NCT00719472|Secondary|Percentage of Patients Who Had an Adverse Event of Any Grade or Seriousness During Cycle 1||Cycle 1|Intent-to-treat (ITT) population: All patients who received at least 1 dose of rituximab regardless of infusion rate.|||Percentage of participants|||Number
1468266|NCT00719472|Primary|Percentage of Patients Who Developed Grade 3 or 4 Infusion-related Reactions (IRR) Resulting From Faster Infusion of Rituximab During Days 1 and 2 of Cycle 2|The percentage of patients who developed Grade 3 or 4 IRRs resulting from faster infusion of rituximab at Cycle 2 was assessed in patients who had previously received rituximab at the standard infusion rate without experiencing a Grade 3 or 4 IRR at Cycle 1. IRRs were a predefined list of Medical Dictionary for Regulatory Activities (MedDRA) terms for infusion-related adverse events occurring on the day of and/or the day after rituximab infusion. The list of IRR terms was compiled based on IRRs observed in the present and previous studies in which rituximab was infused at the standard rate.|Days 1 and 2 of Cycle 2|Per-protocol evaluable population: All patients who received rituximab by faster infusion in Cycle 2 and who did not experience a Grade 3 or 4 infusion-related reaction during the rituximab infusion given at the standard rate during Cycle 1.|||Percentage of participants||95% Confidence Interval|Number
1468267|NCT00719355|Secondary|Onset of Claudication Pain During Constant Work Rate Treadmill Test|Perceived pain onset was recorded during the constant workrate test using the Borg ratio scale. Patient rated their pain from 0-10. Time elapased on the treadmill (minutes) at the onset of pain was recorded.|At 24 weeks|Data were analyzed on all patients with at least 1 follow up constant workrate treadmill test.|||minutes||Standard Deviation|Mean
1468272|NCT00719264|Secondary|Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab|This outcome measure was assessed continuously.|From the date of the first participant treated until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.|||weeks||Full Range|Median
1468273|NCT00719264|Secondary|Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%|The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1468274|NCT00719264|Secondary|Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units|The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.|Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1468275|NCT00719264|Secondary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths|Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.|From the first participant randomized until the last patient discontinued the study treatment + 28 days|Safety Set: The safety set included all participants who received at least one dose of study drug (everolimus, bevacizumab or IFN) and had a valid post-baseline assessment. No AE or occurrence of death, noted at assessment, constitutes a valid post-baseline safety assessment.|||Participants|||Number
1468276|NCT00719264|Secondary|Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.|Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.|A subset of participants from the full analysis set were analyzed. The full analysis set consists of all randomized participants. the subset includes participants who were complete responders or partial responders.|||Months||95% Confidence Interval|Median
1468277|NCT00719264|Secondary|Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.|||Number of participants|||Number
1468278|NCT00719264|Secondary|Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.|Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1468350|NCT00718809|Secondary|Overall Survival|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.|Time from the date of registration to last reported date of survival, assessed up to 5 years|All patients who enrolled and received treatment|||months||95% Confidence Interval|Median
1468279|NCT00719264|Primary|Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab|Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.|Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.|Full Analysis Set: This set consists of all randomized participants.|||Months||95% Confidence Interval|Median
1468280|NCT00719212|Secondary|Progression-free Survival (PFS) Investigator Assessment - Interval From Registration to Disease Progression or Death Due to Any Cause - According to RECIST and CA 125|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat|||months||95% Confidence Interval|Median
1468281|NCT00719212|Secondary|Time To Marker Progression (TTMP) Investigator Assessment - Interval Form the Date of Registration to the Date of Disease Progression as Per GCIG 2005 Definition of CA 125 Progression.|"The GCIG criteria (November 2005) were used to define progressive disease, based on serum CA 125 levels, as follows:~Patients with elevated CA 125 pretreatment and normalization of CA 125 needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart or~Patients with elevated CA 125 pretreatment, which never normalizes needed to show evidence of CA 125 greater than, or equal to, two times the nadir value on two occasions at least 1 week apart or~Patients with CA 125 in the normal range pretreatment needed to show evidence of CA 125 greater than, or equal to, two times the ULN on two occasions at least 1 week apart."|Day 1 of each cycle|Intent To Treat|||months||95% Confidence Interval|Median
1468282|NCT00719212|Secondary|Overall Survival (OS) Investigator Assessment|Interval between the date of registration and the date of death|Day 1 of each cycle during study treatment + follow-up every 6 months for the first 3 years in the study or until death whichever occurs first|Intent To Treat|||months||95% Confidence Interval|Median
1468283|NCT00719212|Secondary|Clinical Benefit Rate (CBR) Investigator Assessmt % of Patients in the gp Who Achieve a Complete Response-CR,Partial Response-PR or Stable Disease-SD for 16wks From Registrat° Considering the Global Response Combining RECIST Criteria and CA125 Assessmts|"RECIST(v1.0):~CR:disappearance of all target les°&non-target les°&normalization of tumor marker level~PR:at least 30% decrease in the sum of the LD of target les°-ref the baseline sum LD OR CR for target les°&incomplete resp/SD for non target les°~SD:insufficient shrinkage for PR or increase for PD-ref the smallest sum LD since ttmt started or Persistence of one/more non-target les°or/&maintenance of tumor marker level above the normal~CA125 level:~PR:elev of CA125 at baseline PR if a ≥ 50% decrease compared to baseline value observed on 2 consec assessmts drawn at least 1 wk apart~CR:elev of CA125 at baseline CR 2 CA125 below ULN observed on 2 consec assessmts drawn at least 1 wk apart~SD:neither CR/PR nor PD~Best overall resp of :~CR:if CR per RECIST & per CA125~PR:if CR per RECIST & PR per CA125 OR CR per RECIST and SD per CA125 with elev CA125 at baseline OR PR per RECIST & CR/PR or SD per CA125~SD:other cases not qualifying for progression-at least 24 wks"|At 16 weeks from registration|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
1468284|NCT00719212|Primary|Objective Response Rate (ORR) Independent Radiology Committee % of Patients in the Group Who Achieve a Complete or Partial Response According to RECIST Criteria and GCIG CA 125 Response Criteria.|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
1468285|NCT00719212|Secondary|Time To Progression (TTP) Investigator Assessment|Interval from the date of registration to the date of disease progression Investigator assessment As per RECIST (v1.0), disease progression represented an increase of at least 20% in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response|Intent To Treat|||months||95% Confidence Interval|Median
1468286|NCT00719212|Primary|Objective Response Rate (ORR) Investigator Assessment: % of Patients in the Group Who Achieve a Complete Response(CR) or Partial Response(PR) According to RECIST Criteria and GCIG CA125 Response Criteria. - Assessments of the Response by the Investigators|"RECIST(v1.0):CR:disappearance of all target lesions or disappearance of all nontarget lesions & normalization of tumor marker level/•PR:at least 30% decrease in the sum of the longest diam(LD) of target les° taking as ref the baseline sum LD OR CR for target les° & incomplete response/SD for nontarget les°.~CR & PR to be confirmed no less than 4 wks after initial doc of response.The def of the resp acc to serum CA125 level was as per GCIGCA125 criteria:~PR:elevated CA125 at baseline PR considered if a ≥ 50% decrease compared to baseline value was observed on 2 consecutive assessmts drawn at least 1 wk apart~CR:elevated CA125 at baseline CR was def with 2 CA125 values below ULN observed on 2 consecutive assessmts drawn at least 1 wk apart A pt was considered to have a best overall resp of:CR:if CR as per RECIST & CA125 /-PR: if CR as per RECIST & PR as per CA125 OR CR as per RECIST and SD as per CA125 with elevated CA125 at baseline OR PR as per RECIST & CR/PR or SD as per CA125"|Radiological Tumor assessment: Every 9 (+/- 1 ) weeks during study treatment until documentation of progression or end of study treatment + confirmation PR or CR no less than 4 weeks after initial documentation of response + CA 125: Day 1 of each cycle|Intent To Treat|||percentage of patients||95% Confidence Interval|Number
1468287|NCT00719186|Secondary|Neonatal Complication Rate||September 2008 - December 2011|Neonatal complications reported per infant, an infant could have more than one complication.|||participants|||Number
1468288|NCT00719186|Secondary|Number of Serious Adverse Events||as few as 5 months, up to 16 months||||events|||Number
1468289|NCT00719186|Secondary|Number of Ovulations||as few as 5 months, up to 16 months||||ovulations|||Number
1468290|NCT00719186|Secondary|Number of Pregnancy||as few as 5 months, up to 16 months||||Participants|||Count of Participants
1468291|NCT00719186|Primary|Live Birth|The primary outcome measure is the occurrence of a live birth during the study period. Safety measures will be the number and type of reported adverse events in subjects and offspring.|as few as 5 months, up to 16 months||||Participants|||Count of Participants
1468292|NCT00719160|Secondary|Gastric pH|"The American Heritage Dictionary defines pH as a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14. The normal pH range for stomach acid is between 1.5 and 3.5."|Day 5 of a high protein diet||||units on a scale of pH||Standard Error|Mean
1468293|NCT00719160|Primary|Percent Change in Intestinal Calcium Absorption|This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.|Day 5 of a high protein diet||||percentage of calcium absorption||Standard Error|Mean
1468294|NCT00719134|Secondary|Pain Free at 2 Hours After Treatment|A secondary measure of attack outcome was based on categorical classification of the pain freedom (pain score = 0) 2.5 hours after onset of headache.|2 hours after treatment|For the secondary endpoint, the proportion of patients who were free from pain 2 hours after treatment, we used a mixed-effects logistic regression model to analyze the individual dichotomous outcomes.|||percent of patients pain free||95% Confidence Interval|Number
1468295|NCT00719134|Primary|Change in Headache Intensity|The primary outcome measure was the change in headache between the baseline pain score recorded 30 min after the onset of headache and the pain score recorded 2 hours later as measured on a visual analog scale ranging from 0 (no pain) to 10 (worst pain imaginable).|2 hours after treatment|For the primary endpoint, change in headache intensity from baseline to 2 hours after treatment, we used generalized linear mixed models with a normal random component and a logarithmic link function to analyze the pain scores.|||percent change||95% Confidence Interval|Mean
1468296|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468297|NCT00719043|Secondary|Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.|"A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0.~This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups."|At Days 10 and 42|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468298|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1468299|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Day 0, Day 10, Day 42, Day 182 and Day 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1468300|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 0, 10, 42, 182, 549 and 559|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1468301|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.|HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 10, 42, 182 and 549|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1468302|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1468303|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1468304|NCT00719043|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Subjects|||Number
1468305|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 0, 182, 192, 224, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1468306|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 0, 182, 549, 559, 591 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1468315|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1468307|NCT00719043|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 0, 182,192, 224, 549 and 729|The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.|||Titers||95% Confidence Interval|Geometric Mean
1468308|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468309|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468310|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
1468311|NCT00719043|Secondary|Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain|GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Days 192 and 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Fold increase||95% Confidence Interval|Geometric Mean
1468312|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 591|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468313|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.|At Day 224|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468314|NCT00719043|Secondary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468348|NCT00718809|Secondary|Expected Toxicities Including Skin Rashes and Diarrhea|Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.|Up to 5 years|All patients|||participants|||Number
1468316|NCT00719043|Secondary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468317|NCT00719043|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1468318|NCT00719043|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.|Within the 43-day (Days 0-42) post-vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1468319|NCT00719043|Primary|Number of Subjects With Medically-attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|From Day 0 to Day 909|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1468320|NCT00719043|Primary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1468321|NCT00719043|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.|Within the 7-day (Days 0-6) post vaccination periods|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.|||Subjects|||Number
1468322|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468323|NCT00719043|Primary|Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468324|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.|At Days 182 and 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1468325|NCT00719043|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.|HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Days 549 and 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Titers||95% Confidence Interval|Geometric Mean
1468519|NCT00717314|Secondary|Percentage Change in Creatinine Clearance From Baseline|Creatinine clearance was calculated using the Cockcroft and Gault formula.|Weeks 16, 28, 40, and 52|PP population|||percentage change from baseline||Standard Deviation|Mean
1468326|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group|At Day 192|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468327|NCT00719043|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.|At Day 559|The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.|||Subjects|||Number
1468328|NCT00718887|Secondary|Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results|Hematology testing assessed levels of hemoglobin, white blood cells, platelets, neutrophils, international normalized ration, red blood cells, lymphocytes, and monocytes.|Day 1 through Week 48|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
1468329|NCT00718887|Secondary|Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study drug.|Continually from Day 1 through Week 48, and through 24-week follow-up period|"Participants who were randomized and received at least~1 dose of study drug."|||Participants|||Number
1468330|NCT00718887|Secondary|Number of Participants With Genotypic Resistance to Entecavir||At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||Participants|||Number
1468331|NCT00718887|Secondary|Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion||At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||Participants|||Number
1468332|NCT00718887|Secondary|Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion||At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and who were HBeAg-positive at baseline. n=number of evaluable participants.|||Percentage of participants|||Number
1468333|NCT00718887|Secondary|Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)|ULN=upper limit of normal. ALT normalization= ≤1*ULN, among participants with baseline ALT >1*ULN|At Weeks 12 and 48 from Day 1|Participants who were randomized, who received at least 1 dose of study drug, and whose ALT values were >1*ULN at baseline. n=number of evaluable participants.|||Percentage of participants|||Number
1468334|NCT00718887|Secondary|Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing|HBV=hepatitis B virus|At Weeks 12 and 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug. n=number of evaluable participants."|||log10 IU/mL||Standard Deviation|Mean
1468335|NCT00718887|Secondary|Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing|HBV=hepatitis B virus. HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 48 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
1468336|NCT00718887|Primary|Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing|HBV DNA Level <50 IU/mL=approximately 300 copies/mL.|At Week 12 from Day 1|"Participants who were randomized and received at least~1 dose of study drug."|||Percentage of participants|||Number
1468337|NCT00718861|Secondary|Change in Height at Years 7, 8 and 9 Relative to Year 6|Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with evaluable measurements at both Year 6 and the post-Year 6 visit, as determined by the analysis window.|||millimeters (mm)||Standard Error|Least Squares Mean
1468338|NCT00718861|Secondary|Mean of Time to First Clinical Fracture|The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.|over 3 years of study duration|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.|||Days||Standard Error|Mean
1468349|NCT00718809|Secondary|Disease Control Rate|Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.|Up to 5 years|All patients who enrolled and received treatment|||months||95% Confidence Interval|Median
1468339|NCT00718861|Secondary|Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6|Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.|Year 6 (extension 2 baseline), Year 9 (3 years of study duration)|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n= the number of patients with the event|||participants|||Number
1468340|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
1468341|NCT00718861|Secondary|Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
1468342|NCT00718861|Secondary|Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9|Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.|||ng/ml||Full Range|Median
1468343|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1468344|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 – Year 0)/Year 0.|Year 0 (core baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1468345|NCT00718861|Secondary|Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8, Year 9|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1468346|NCT00718861|Secondary|Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (extension 2 baseline), Year 7, Year 8|The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.|||percentage change of BMD||Standard Error|Least Squares Mean
1468347|NCT00718861|Primary|Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9|Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 – Year 6)/Year 6.|Year 6 (baseline) and Year 9|The modified intent-to-treat (MITT) population included all patients in the ITT population who had DXA measurements of the total hip at Visit 11 (Year 6) and Visit 15 (Year 9). This was the primary population for the primary efficacy parameter.|||Percentage Change of BMD||Standard Error|Least Squares Mean
1468351|NCT00718809|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Time from the date of registration to the first reported outcome event, assessed up to 5 years|All patients who enrolled and received treatment.|||months||95% Confidence Interval|Median
1468352|NCT00718809|Primary|Objective Response Rate (Complete and Partial Response)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.|Up to 5 years|All patients with at least one post baseline measurement.|||percentage of participants||95% Confidence Interval|Number
1468353|NCT00718770|Primary|Change in Tumor Size|To assess the tumor response of recurrent or metastatic radioiodine resistant thyroid cancer to bexarotene therapy using standard RECIST criteria|1 year|Adults with radioiodine resistant metastatic follicular cell derived thyroid cancer|||cm||Standard Deviation|Mean
1468354|NCT00718718|Secondary|Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B)|Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.|Baseline, Week 2|Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
1468355|NCT00718718|Secondary|Serum Sirukumab Concentrations Through Week 38 (Part B)|Sirukumab Concentrations in serum were measured.|Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38|Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.|||Microgram per milliliter||Standard Deviation|Mean
1468356|NCT00718718|Secondary|Serum Sirukumab Concentrations Through Week 38 (Part A)|Sirukumab Concentrations in serum were measured.|Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38|Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively.|||Microgram per milliliter||Standard Deviation|Mean
1468357|NCT00718718|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A)|An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant’s assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant’s assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.|Week 12|Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
1468358|NCT00718718|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B)|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.|Baseline, Week 12|Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively.|||Units on a Scale||Standard Deviation|Mean
1468359|NCT00718718|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B)|An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant’s assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant’s global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician’s global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant’s assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and serum C-reactive protein (CRP).|Week 12|Population analyzed included all randomized participants in Part B.|||Percentage of Participants|||Number
1468423|NCT00718315|Secondary|Percentage of Participants With Erythema Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
1468360|NCT00718666|Secondary|Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
1468361|NCT00718666|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
1468362|NCT00718666|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.|||Participants|||Count of Participants
1468363|NCT00718666|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.|||Participants|||Count of Participants
1468364|NCT00718666|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.|||Participants|||Count of Participants
1468365|NCT00718666|Secondary|Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers|"Vaccine response was defined as:~for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay."|At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1468366|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, determined by Public Health England [PHE] laboratory assay.|At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Titers||95% Confidence Interval|Geometric Mean
1468367|NCT00718666|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values|The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay.|At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1468368|NCT00718666|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers|Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer < 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1468424|NCT00718315|Secondary|Percentage of Participants With Pain|Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
1468425|NCT00718315|Secondary|Percentage of Participants With Pruritus|Pruritus is defined as intense localized itching|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
1468369|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers|Titers were given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC,hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)|||Titers||95% Confidence Interval|Geometric Mean
1468370|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8.|At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all vaccinated subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix1 and Nimenrix 2 Group)|||Participants|||Count of Participants
1468371|NCT00718666|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Titers||95% Confidence Interval|Geometric Mean
1468372|NCT00718666|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 or 1:128. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Participants|||Count of Participants
1468373|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Titers||95% Confidence Interval|Geometric Mean
1468374|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group.|At Month 60 (pre-primary vaccination with Nimenrix vaccine)|The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.|||Participants|||Count of Participants
1468375|NCT00718666|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values|The cut-off values for the assay were ≥ 0.3 μg/ml and ≥ 2.0 μg/ml respectively.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468376|NCT00718666|Secondary|Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations|Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml).|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||μg/ml||95% Confidence Interval|Geometric Mean
1468377|NCT00718666|Secondary|rSBA Antibody Titers.|Titers are given as geometric mean titers (GMTs), calculated for all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 5 (60 months following primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468378|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs), calculated on all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively by GSK Biologicals’ laboratory assay.|At Year 5 (60 months post-primary vacccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468426|NCT00718315|Secondary|Percentage of Participants With Erythema|Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries|Days 0, 15, and 30|ITT Population|||percentage of participants||95% Confidence Interval|Number
1468379|NCT00718666|Secondary|rSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 3 (36 months following primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468380|NCT00718666|Secondary|rSBA Antibody Titers.|Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals’ laboratory assay.|At Year 3 (36 months post-primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468381|NCT00718666|Secondary|rSBA Antibody Titers|Titers were given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals’ laboratory assay.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468382|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128 determined by Public Health England (PHE) laboratory assay.|At Year 5 (60 months post-primary vacccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468383|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 5 (60 months post-primary vacccination).|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468384|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. Titers were determined by Public Health England (PHE) laboratory assay.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468385|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468386|NCT00718666|Secondary|Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay|rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468387|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
1468388|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
1468389|NCT00718666|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Titres||95% Confidence Interval|Geometric Mean
1468390|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468391|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 3 (36 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468392|NCT00718666|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.|At Year 1 (12 months post vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468393|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.|At Year 5 (60 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468394|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.|At Year 3 (36 months post primnary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468395|NCT00718666|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off|hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.|At Year 1 (12 months post primary vaccination)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.|||Participants|||Count of Participants
1468396|NCT00718640|Secondary|Renal Function|Renal function was analysed by creatinine clearance. Creatinine clearance was calculated by Cockroft-Gault fourmula. Creatinine clearance is equal to 140 minus age multiplied by weight and constant (1 for men and 0.85 for women) divided by creatinine in (micro mole per liter)|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468397|NCT00718640|Secondary|Quality of Life Assessed by Euro Quality of Life (EQ-5D)|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression where 1=better health state (no problems), 3=worst health state. Scoring formula was developed by Euro quality of life group which assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468398|NCT00718640|Secondary|Quality of Life Assessment by QLQ C-30|The quality of life was assessed by the questionnaire QLQ C-30 designed by European Organization for the Research and Treatment of Cancer (EORTC). The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer participants. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale is equal to higher level of symptomatology or problems.|Final Visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468399|NCT00718640|Secondary|Karnofsky Performance Status (KPS) Score|The KPS is used to quantify participant’s general well-being and activities of daily life and participants are classified based on their functional impairment. KPS score is 11-level score which ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.|Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468400|NCT00718640|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score|The ECOG PS Score 0 versus 1, wherein 0 signifies fully active, able to carry all pre-disease performance without restriction and 1 signifies restriction in physically strenuous activity but ambulatory (able to walk) and able to carry out work on a light or sedentary nature.|Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468401|NCT00718640|Secondary|Duration of Response|The duration of Response was defined as the time of first recorded achievement of a particular response level, which was defined according to IMWG uniform response criteria, as either complete response, stringent complete response, very good partial response or partial response included only responding participants, until the participants were assessed to have progressive disease.|Day 1 (Start of treatment) until the date of first documented achievement of response|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468402|NCT00718640|Secondary|Time to Progression (TTP) of Disease|The TTP was defined as the time from the date of starting treatment until the date of first documented evidence of progression of disease or death.|Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468403|NCT00718640|Secondary|Best Response to Treatment|It was assessed by IMWG criteria. It defines complete response as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Very good partial response as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or > reduction in serum and urine M-protein level<100 mg per 24 hour. Partial Response as <=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by <=90% or to <200mg per 24 hr.|Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468404|NCT00718640|Primary|Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria|The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or >reduction in serum and urine M-protein level <100 milligram(mg) per 24 hour(hr).PR as <=50% reduction of serum and <= 90% of urine M-protein or up to <200 mg/24 hr.|Week 24 or Early termination visit (30-45 days after last dose)|The study was terminated. Due to insufficient number of participants, the outcome measure data was not analyzed.||||||
1468405|NCT00718549|Secondary|Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 129|MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment.|12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
1468406|NCT00718549|Secondary|Percentage of Participants With MRD According to Rawstron Criteria in Participants With CR or PR According to Clinical and Biochemical Factors at Week 29|MRD: the presence of tumor cells in bone marrow, using 4-color flow cytometry of CD19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR (>/=2 months after last treatment): no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and MRD after study treatment.|8 weeks after the last dose of rituximab during induction treatment (Week 29)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
1468419|NCT00718510|Primary|Change From Baseline in Mean Positive and Negative Syndrome Scale (PANSS) Total and Positive, Negative and General Psychopathology Subscale Scores at 3 Weeks|The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS) total score and PANSS positive, negative and general psychopathology subscale scores. The PANSS is a 30-item scale used to evaluate the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranges from 30 to 210 with a higher score indicating a greater severity of symptoms. The PANSS positive symptom subscale score (7 items) ranges from 7=absent to 49=extreme; the PANSS negative subscale score (7 items) ranges from 7=absent to 49=extreme; and the PANSS general psychopathology subscare score (16 items) ranges from 16=absent to 112=extreme.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis|||units on a scale||Standard Deviation|Mean
1468407|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 129|CR was achieved if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment.|12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||percentage of participants|||Number
1468408|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors at Week 29|CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline). Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed the relationship between clinical markers and clinical outcome (response) after study treatment.|8 weeks after the last dose of rituximab during induction treatment (Week 29)|ITT population. Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among Participants included in Overall IIT population only.|||percentage of participants|||Number
1468409|NCT00718549|Secondary|PFS Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL According to Clinical and Biochemical Factors|PFS: time from date of randomization to date of PD, relapse, or death from any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in previously noted enlargement of liver or spleen by >/=50%; an increase in number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; or occurrence of cytopenia attributable to CLL. Rai Stage: staging for CLL, based on lymphocyte, red blood cell and platelet counts and size of lymph nodes, spleen, and liver. Rai Stage I or II are intermediate risk CLL and Rai Stage III or IV are high risk CLL. This outcome measure assessed relationship between clinical markers and clinical outcome (PFS) after study treatment.|From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)|ITT population. Overall Number of Participants Analyzed: participants evaluable for this outcome; Number Analyzed: participants evaluable for specified category. This outcome was planned to be reported for groups defined by clinical and biochemical factors (i.e. reported categories) among All Randomized Participants only.|||years||95% Confidence Interval|Median
1468410|NCT00718549|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) According to Rawstron Criteria in Participants With CR or PR|MRD was defined by the presence of tumor cells in bone marrow, using 4-color flow cytometry of cluster of differentiation (CD)19/CD5/CD20/CD79b. MRD was assessed in participants who achieved CR or PR. CR: if participants met all of the following criteria >/=2 months after last treatment: no Ly/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, PL >100,000/mcL, Hb >11.0 g/dL, BM sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly; a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline).|8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||percentage of participants||95% Confidence Interval|Number
1468411|NCT00718549|Secondary|Percentage of Participants With CR or PR Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL|CR was achieved if participants met all of the following criteria >/= 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils >1500/mcL, platelets (PL) >100,000/mcL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), bone marrow (BM) sample must be normocellular for age with lymphocytes <30% of nucleated cells. PR: a reduction in Ly (decrease in lymph node size by >/=50% compared to pre-treatment state, no increase in any lymph node, no new enlarged lymph node); a reduction of >/=50% from pre-treatment state in the lymphocytes count, and in enlargement of the spleen or liver; any one of the following: neutrophils >1500/mcL, PL >100,000/mcL (or 50% improvement from baseline), Hb >11.0 g/dL (or 50% improvement from baseline).|8 weeks after the last dose of rituximab during induction treatment (Week 29) and 12 weeks after the end of maintenance treatment or observation phase (Week 129)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||percentage of participants||95% Confidence Interval|Number
1468420|NCT00718328|Primary|Perihematomal Edema|Solitary patient lost to follow up (out of state)|Days 7 and 14||||Relative perihematomal edema||Standard Deviation|Mean
1468412|NCT00718549|Primary|Progression-Fee Survival (PFS) Assessed According to the NCI Revised Guidelines for the Diagnosis and Treatment of CLL|PFS was defined as the time from date of randomization to date of PD, relapse, or death due to any cause. Participants alive with no evidence of PD or relapse were censored at date of last clinical examination. PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (>1.5 cm), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of >/=50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000/mcL; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.|From randomization to PD, relapse, or death due to any cause (overall approximately 5 years)|ITT population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||years||95% Confidence Interval|Median
1468413|NCT00718549|Primary|Percentage of Participants With Disease Progression (PD), Relapse, or Death Due to Any Cause Assessed According to the National Cancer Institute (NCI) Revised Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia (CLL)|PD occurred if any of the following events was observed: appearance of any new lesion, such as enlarged lymph nodes (greater than [>]1.5 centimeters [cm]), splenomegaly, hepatomegaly, or other organ infiltrates; an increase of greater than or equal to (>/=) 50 percent (%) in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by >/=50%; an increase in the number of blood lymphocytes by >/=50% with B-lymphocytes >/=5000 per microliter (/mcL); transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL.|From randomization to PD, Relapse, or death due to any cause (overall approximately 5 years)|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had at least one post-treatment efficacy measurement available. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants|||Number
1468414|NCT00718523|Secondary|Overall Survival (OS)|Interval between the date from randomization to death from any cause whichever came first.|Day 1 of each cycle up to 4 years after randomization|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
1468415|NCT00718523|Secondary|Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
1468416|NCT00718523|Primary|Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.|"A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:~Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR~Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR~CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart"|Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle|Unstratified Intent To Treat|||months||95% Confidence Interval|Median
1468417|NCT00718510|Secondary|Change From Baseline in Mean Calgary Depression Scale for Schizophrenia (CDSS) at 3 Weeks|The Secondary Outcome Measure was the Calgary Depression Scale for Schizophenia (CDSS). The CDSS is a 9-item scale that is used to rate the depressive symptoms in patients with schizophrenia. For each CDSS item, symptom severity was rated on a 3-point scale, from 0=absent to 3=severe. The CDSS total score ranges from 0 to 27 with a higher score indicating a greater severity of symptoms.|Baseline and 3 Weeks||||units on a scale||Standard Deviation|Mean
1468418|NCT00718510|Secondary|Change From Baseline in Mean Clinical Global Impression (CGI) Scale at 3 Weeks|The Secondary Outcome Measure was the Clinical Global Impression (CGI) scale. The CGI is a 3-item scale that rates treatment response and monitors the clinical course of all psychiatric illnesses including schizophrenia. Within the CGI, the Severity of Illness was rated on a 7-point scale, 0=not assessed to 7=among the most severely ill patients. For Global Improvement, the total improvement following treatment as compared to at baseline of the trial was rated on a 7-point scale, 0=not assessed to 7=very much worse.|Baseline and 3 Weeks|All participants who received all doses of each intervention and completed all study visits were included in the efficacy analysis|||units on a scale||Standard Deviation|Mean
1468421|NCT00718315|Secondary|Percentage of Participants With Pain Stratified by Severity Grade|The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
1468422|NCT00718315|Secondary|Percentage of Participants With Pruritus Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.|30 Days|ITT Population|||percentage of participants|||Number
1468597|NCT00717041|Primary|Participants With Cognitive Impairment by Six Item Screener|Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect|2 hours||||participants|||Number
1468427|NCT00718315|Secondary|Time to Appearance of Skin Rash|Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE|Days 0, 15, and 30|ITT Population|||Days||95% Confidence Interval|Median
1468428|NCT00718315|Primary|Percentage of Participants With Skin Rash Stratified by Severity Grade|The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death|30 Days|ITT Population|||percentage of participants|||Number
1468429|NCT00718315|Primary|Percentage of Participants Who Develop Skin Rash|Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line “Rash/desquamation” – short name “rash”).|30 Days|ITT Population|||percentage of participants||95% Confidence Interval|Number
1468430|NCT00718302|Secondary|SMFA - Bother Index|The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
1468431|NCT00718302|Secondary|The Short Musculoskeletal Functional Assessment (SMFA) Score|The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.|3 months, 6 months, 9 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
1468432|NCT00718302|Secondary|American Orthopedic Foot and Ankle Society Score (AOFAS) Scores|American Orthopedic Foot and Ankle Society Score (AOFAS) score. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. A subject can score anywhere from 0-100, 100 being best.|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||units on a scale||Standard Deviation|Mean
1468433|NCT00718302|Secondary|Percentage Normal Peroneal Tendons|Percentage of Participants with Normal Peroneal Tendons|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.|||percentage of participants|||Number
1468434|NCT00718302|Primary|Percentage of Nonpalpable Hardware|Percentage of Participants with Nonpalpable Hardware|3 months, 6 months, 12 months|Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP)|||percentage of participants|||Number
1468435|NCT00718237|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool antigen prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
1468436|NCT00718237|Primary|Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
1468437|NCT00718237|Secondary|Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A|Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition. Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes. Score of >8 and <=16 was considered moderate, and >16 was considered severe.|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., protocol violators, unevaluable due to detection of wild-type rotavirus in stool prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range).|||Number of participants|||Number
1468438|NCT00718120|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1468480|NCT00717977|Primary|Daytime (6:00 a.m. - Midnight) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from 6 a.m. to midnight.|48-72 hours||||mg/dL||Standard Deviation|Mean
1468439|NCT00718120|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1468440|NCT00718120|Secondary|Number of Subjects Reporting Solicited Symptoms|Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face, and fever.|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
1468441|NCT00718120|Primary|Fold Increase From Baseline in Serum HI Antibody Titer|The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.|At Day 21||||fold increase|||Number
1468442|NCT00718120|Primary|Number of Seroprotected Subjects|Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.|At Day 0 and 21||||subjects|||Number
1468443|NCT00718120|Primary|Number of Seroconverted Subjects|Seroconversion, defined as a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination serum HI titer, is presented for all three vaccine influenza virus strains.|At Day 21||||subjects|||Number
1468444|NCT00718120|Primary|Hemagglutination Inhibition (HI) Antibody Titers|Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.|At Day 0 and 21||||titer||95% Confidence Interval|Geometric Mean
1468445|NCT00718094|Primary|Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.|"This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity.~Each variable is scored from 0–3 so that the total index score ranges from 0–12; 0–2: remission; 3–6: mild; 7–10: moderate; >10: severe UC."|day 56||||Participants|||Count of Participants
1468446|NCT00718081|Secondary|Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief|At the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.|Up to 12 hours after surgery||||percentage of patients|||Number
1468447|NCT00718081|Primary|SPID-12|The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The scores after summing could range from -122 to +122. A higher SPID-12 score is better.|12 hours after surgery||||units on a scale||Standard Error|Least Squares Mean
1468448|NCT00718042|Secondary|ESA Chagas Testing in Chagas Endemic Population|Specimen collected in Chagas endemic areas in South or Central America (524) tested with ESA Chagas and licensed test for T cruzi antibody. Specimens repeatedly reactive with either screening assay and/or ESA Chagas positive were tested with supplemental assay (RIPA). Presentation of ESA Chagas results for 132 specimens from a Chagas endemic population that were RIPA positive.|2 months|Total of 132 out of the 524 specimens from Chagas endemic areas that were tested RIPA positive per protocol.|||participants|||Number
1468449|NCT00718042|Secondary|ESA Chagas Sensitivity in Serologically Positive Non-US Specimens|ESA Chagas Sensitivity in a non-US population was determined for the 85 out of the total 287 serologically positive specimens (202 US Serology Positive specimens were excluded). These specimens were collected from individuals positive for T cruzi antibodies based on 2 different serologic tests for antibodies to T cruzi in Argentina and were tested with ESA Chagas.|3 months|A total of 85 serum specimens from non-US individuals reactive for T cruzi antibodies per protocol.|||participants|||Number
1468450|NCT00718042|Primary|ESA Chagas Sensitivity|Specimens from individuals known to be T cruzi parasite positive were tested with ESA Chagas assay.|3 months|Specimens from 110 subjects known to be positive for T cruzi parasite tested with ESA Chagas per protocol.|||participants|||Number
1468451|NCT00718042|Primary|ESA Chagas Specificity|Preselected US blood donor specimens (330) presumed T cruzi antibody negative negative that were tested only with the investigational ESA Chagas.|3 months|Determine percentage of donor specimens ESA Chagas negative in a presumed negative population per protocol.|||participants|||Number
1468452|NCT00718042|Secondary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas.|A total of 41,760 US blood donor specimens were tested by ABBOTT PRISM Chagas. Of these specimens, 58 out of 79 specimens were T cruzi antibody repeatedly reactive by ABBOTT PRISM Chagas (26 from 16,249 donor specimens tested in design validation phase and 32 from 25,511 specimens from the Chagas extended evaluation). Donor specimens that were repeatedly reactive with the licensed T cruzi antibody assay, but PRISM Chagas nonreactive (6) and specimens PRISM Chagas grayzone negative (15) were excluded from this analysis.|15 months|A total of 58 US blood donor specimens were PRISM Chagas repeatedly reactive were included per protocol.|||participants|||Number
1468453|NCT00718042|Secondary|PRISM Chagas Reactivity in Chagas Endemic Population|Population of specimen collected in Chagas endemic area in South/Central America (524) were tested to demonstrate reactivity with the PRISM Chagas assay in a population with a 5% or greater prevalence of infection with T cruzi antibody. specimens tested with PRISM Chagas assay and licensed test for T cruzi antibody and if repeatedly reactive with either assay the specimens were tested with supplemental assay (RIPA). Data presented with PRISM Chagas and RIPA results.|2 months|Total of 524 specimens from Chagas endemic areas tested with PRISM Chagas per protocol.|||participants|||Number
1468454|NCT00718042|Primary|PRISM Chagas Sensitivity|Specimens from subjects known to be T cruzi parasite positive were tested with PRISM Chagas assay.|6 months|Specimens from 110 individuals known to be positive for T cruzi parasite were tested with PRISM Chagas assay per protocol.|||participants|||Number
1468481|NCT00717977|Primary|Overall Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average over all 24 hours.|48-72 hours||||mg/dL||Standard Deviation|Mean
1468455|NCT00718042|Secondary|PRISM Chagas Reactivity Serology Positive Specimens|Total of 85 specimens from subjects from South America known to be positive for T cruzi antibodies and 202 US blood donor specimens that were repeatedly reactive on a licensed test for antibodies to T cruzi were tested with the PRISM Chagas assay and supplemental testing (RIPA).|4 months|Total of 287 specimens presumed T cruzi antibody positive per protocol.|||participants|||Number
1468456|NCT00718042|Primary|PRISM Chagas Specificity|Total of 16,249 serum and plasma blood donor specimens tested with PRISM Chagas assay during design validation phase. Repeatedly reactive specimens were tested further with a supplemental assay [radioimmune precipitation assay (RIPA)].|6 months|All fresh blood donor specimens tested with PRISM Chagas assay during design validation phase per protocol.|||participants|||Number
1468457|NCT00717977|Primary|Glucose Variability Measure: Amplitude of Glycemic Excursions by Time of Day|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468458|NCT00717977|Primary|Glucose Variability Measure: Mean Amplitude of Glycemic Excursions by Age Group|The Mean Amplitude of Glycemic Excursions also known as MAGE depicts the upward and downward acute glucose fluctuations seen in the sensor data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468459|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Time of Day|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||Percent||Inter-Quartile Range|Median
1468460|NCT00717977|Primary|Glucose Variability Measure- Coefficient of Variation by Age Group|The Coefficient of Variation is calculated by dividing the standard deviation by the mean glucose. Each subject received a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||Percent||Inter-Quartile Range|Median
1468461|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Time of Day||48-72 hours||||mg/dL/min||Inter-Quartile Range|Median
1468462|NCT00717977|Primary|Glucose Variability Measure- Absolute Rate of Change by Age Group||48-72 hours||||mg/dL/min||Inter-Quartile Range|Median
1468463|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Time of Day|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468464|NCT00717977|Primary|Glucose Variability Measure- Standard Deviation by Age Group|Here, 'Standard Deviation' is a measure of glucose variability. This measure was calculated by taking the SD of all glucose values for each subject. Each subject has a SD value. The median and quartiles of this measure over all subjects were reported.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468465|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels >140 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels >140 mg/dl' for all 24 hours."|48-72 hours||||Percent||Inter-Quartile Range|Median
1468466|NCT00717977|Primary|Percentage of Sensor Glucose Levels >140 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1468467|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dl by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
1468468|NCT00717977|Primary|Percentage of Sensor Glucose Levels >120 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1468469|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dl by Time of Day|"The Percentage of Sensor Glucose Levels <=60 mg/dl was calculated for each subject separately for the daytime and nighttime period. The median and quartiles over all subjects were reported.~Here the data is different with data analyzed by age group, which is a subgroup analysis on 'percentage of sensor glucose levels <=60mg/dL' for all 24 hours."|48-72 hours||||Percent||Inter-Quartile Range|Median
1468470|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=60 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1468471|NCT00717977|Primary|Percentage of Sensor Glucose Levels <=70 mg/dl by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
1468472|NCT00717977|Primary|Distribution of Sensor Glucose Levels <=70 mg/dL by Age Group||48-72 hours||||Percent||Inter-Quartile Range|Median
1468473|NCT00717977|Primary|Percentage of Sensor Glucose Levels 71-120 mg/dL by Time of Day||48-72 hours||||Percent||Inter-Quartile Range|Median
1468474|NCT00717977|Primary|Percentage of Sensor Glucose Levels Between 71-120 mg/dL by Age Group|The Percentage Sensor Glucose Levels between 71-120 mg/dL was calculated for each subject. The median and quartiles over all subjects were reported here.|48-72 hours||||Percent||Inter-Quartile Range|Median
1468475|NCT00717977|Primary|Nighttime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The nighttime nadir reflects the lowest point on the sensor glucose curve registered among nighttime values.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468476|NCT00717977|Primary|Daytime Nadir Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data. The daytime nadir reflects the lowest point on the sensor glucose curve registered among daytime values.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468477|NCT00717977|Primary|Peak Nightime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468478|NCT00717977|Primary|Peak Daytime Sensor Glucose Value by Age Group|The calculation of peak and nadir glucose was restricted to days with >=12 hours and nights with >=4 hours of sensor glucose data.|48-72 hours||||mg/dL||Inter-Quartile Range|Median
1468479|NCT00717977|Primary|Nighttime (Midnight - 6:00 a.m.) Mean Sensor Glucose by Age Group|Mean glucose value was calculated for every hour of the 24 hours of the day. This measure is the average from midnight to 6 a.m.|48-72 hours||||mg/dL||Standard Deviation|Mean
1468482|NCT00717912|Secondary|Insulinemic Index|"The specific measure that will be use to determine the insulinemic responses is the change in blood insuline levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.~Sugar syrup was used as the reference food, giving it a insulinemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge||||% of the GI of the glucose||Standard Deviation|Mean
1468483|NCT00717912|Primary|Glycemic Index|"The specific measure that will be use to determine the glycemic responses is the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate.~Sugar syrup was used as the reference food, giving it a glycemic index value of 100 by definition. The AUC of the test food is divided by the AUC of the standard (glucose) and multiplied by 100. Low GI: 55 or less, Medium GI: 56-69, High GI: 70 and above"|Every 48 hours (each new intervention), over a 2 hour blood glucose challenge||||% of GI of the glucose||Standard Deviation|Mean
1468484|NCT00717886|Primary|Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).||2 years||||participants|||Number
1468485|NCT00717873|Primary|Hospital Length of Stay|an average of 10 days|Admission to Discharge||||days||Standard Deviation|Mean
1468486|NCT00717860|Secondary|Number of Participants With Favorable Overall Response at the End of Study Therapy|Favorable overall response for each infection category of deep-seated fungal infections was based on the determination of the Independent Efficacy Assessment Committee.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|Per Protocol Set (PPS) population.|||Participants|||Number
1468487|NCT00717860|Secondary|Number of Participants With a Specific Safety Finding|A specific safety finding was defined as a drug-related adverse experience, a serious drug-related adverse experience, or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|APaT population.|||Participants|||Number
1468488|NCT00717860|Primary|Number of Participants With a Significant Drug-related Adverse Experience|A significant drug-related adverse experience was defined as a serious drug-related adverse experience or a drug-related adverse experience leading to study therapy discontinuation.|1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis|All Participants as Treated (APaT) population.|||Participants|||Number
1468489|NCT00717756|Primary|Response Rate by Recist Criteria|"radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD~It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed."|on average about every 2 months until progression, on average about 4 months.||||participants|||Number
1468490|NCT00717574|Primary|The Effect of Nitrous Oxide on Bispectral Index (BIS) and State Entropy Index (SE)|"We planned this study to compare the effect of adding N2O on BIS and SE during an intravenous or an inhalation anesthetic. We hypothesized that neither BIS nor SE would decrease in response to the addition of N2O to a Propofol anesthetic. We also hypothesized that neither BIS nor SE would decrease in participants under Sevoflurane anesthesia if the inspired concentration of Sevoflurane were carefully and continuously adjusted to maintain a constant end-tidal concentration during the addition and discontinuation of N2O.~BIS (0-100) and SE (0-92) are unitless, ordinal indices of anesthetic depth. Both indices are decreased when the depth of anesthesia is increased."|From baseline to 20 minutes after the addition of 60% nitrous oxide||||units on a scale||Standard Deviation|Mean
1468491|NCT00717522|Secondary|Tumor Response as Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee Guidelines|Changes in only the longest diameter (LD) of tumor lesions are used in RECIST criteria. Evaluation of target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions.|Assessed every 8 weeks for the first 8 months and then every 12 weeks thereafter, and at treatment discontinuation. Median treatment duration was 49 days (range: 3 to 102 days).|This analysis was not done. Study enrollment was suspended due to a corporate strategic decision unrelated to patient safety, and the protocol was amended to evaluate safety only (efficacy data was stored but not cleaned or analyzed unless related to safety).||||||
1468492|NCT00717522|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, or Discontinuations Due to AEs|An adverse event (AE) is defined as any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a study subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the study subject’s health, including laboratory test values, regardless of etiology. A serious adverse event (SAE) is defined as any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. For more details, please see the Adverse Events section of this record.|AEs/SAEs were recorded from informed consent to 30 days post treatment discontinuation visit. Median treatment duration was 49 days (range: 3 to 102 days).|All participants|||participants|||Number
1468518|NCT00717314|Secondary|Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52|The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.|Week 52|PP population|||percentage of participants|||Number
1468493|NCT00717418|Other Pre-specified|Schirmer's Test With and Without Anesthesia at Baseline|Schirmer’s Test with and without anesthesia at baseline. The Schirmer’s test is performed on each eye with and without anesthesia (numbing eye drop). The amount of wetting produced by the eye was measured in millimeters using a graduated paper scale. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm), Dry eye = less than 15 mm). A larger number correlates to better tear production, a smaller number correlates to reduced tear production.|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit).|||millimeters (mm)||Standard Deviation|Mean
1468494|NCT00717418|Primary|Ocular Surface Disease Index (OSDI) Total Score at Baseline|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Baseline|Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.|||Scores on a Scale||Standard Deviation|Mean
1468495|NCT00717405|Secondary|Overall Survival (OS) Duration|OS was defined as the time from the first administration of neoadjuvant treatment to death of any cause. OS was estimated using Kaplan-Meier method.|Up to 5 years|ITT population.|||months||95% Confidence Interval|Median
1468496|NCT00717405|Secondary|Percentage of Participants Who Were Alive at 3 and 5 Years||3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1468497|NCT00717405|Secondary|Recurrence Free Survival (RFS) Duration|RFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.|||months||95% Confidence Interval|Median
1468498|NCT00717405|Secondary|Percentage of Participants Who Were Recurrence Free at 3 and 5 Years|A participant was considered recurrence free if the participant did not experience local or regional recurrence (wall or axillaries nodes), or occurrence of distant metastases (including soft tissue and distal lymph nodes).|3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1468499|NCT00717405|Secondary|Disease Free Survival (DFS) Duration|DFS was estimated using Kaplan-Meier method.|Up to 5 Years|ITT population.|||months||95% Confidence Interval|Median
1468500|NCT00717405|Secondary|Percentage of Participants Who Were Disease Free at 3 and 5 Years|A participant was considered disease free if the participant did not experience any of the following events: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colon carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause.|3, 5 years|ITT population.|||percentage of participants||95% Confidence Interval|Number
1468501|NCT00717405|Secondary|Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit||Baseline, Neoadjuvant Final Visit (Week 25)|Safety population: Number of participants included all the participants who received at least one infusion of bevacizumab. n included participants who were evaluable at that time point.|||Units per milliliter (U/mL)||Standard Deviation|Mean
1468502|NCT00717405|Secondary|Percentage of Participants Who Underwent Lymph Node Resection|Among the participants who were planned to undergo mastectomy, lymph node resection was also performed by the physician depending up on the participant's breast cancer grades.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.|||percentage of participants|||Number
1468503|NCT00717405|Secondary|Percentage of Participants With Macroscopically Visible Tumor|Local pathologists assessed the tumor whether it was macroscopically visible or not and percentage of participants for whom the tumor was macroscopically visible was reported.|Anytime between Week 26 and Week 29|ITT population. Included participants who underwent mastectomy.|||percentage of participants|||Number
1468504|NCT00717405|Secondary|Number of Participants Who Underwent Mastectomy|Surgery included a mastectomy with axillary node dissection and had to be performed at least 4 weeks after the last infusion of neoadjuvant bevacizumab treatment.|Anytime between Week 26 and Week 29|ITT population.|||participants|||Number
1468505|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on overall clinical response at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed. n included number of participants who were evaluable at a particular time point.|||percentage of participants|||Number
1468506|NCT00717405|Secondary|Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit|Breast tumor was physically evaluated during the study which included assessment for inflammatory signs and for overall clinical response. Participant with response from baseline based on inflammatory signs at Cycle 5 and final treatment visit were presented.|Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25)|ITT population. Number of participants analyzed included participants for whom tumor physical examination was performed and were evaluated for response from baseline assessment of inflammatory signs. n included number of participants who were evaluable at a particular time point.|||percentage of participants|||Number
1468507|NCT00717405|Secondary|Percentage of Participants With a PCR According to the Chevallier Classification|PCR was assessed at the time of definitive surgery according to Chevallier classification and centrally reviewed by an independent committee under blinded conditions. The Chevallier classification for grading of therapeutic effect related to the primary tumor site and axillary lymph nodes was defined by microscopic changes as follows - Grade 1: Disappearance of all tumors either in the breast or in the nodes, Grade 2: Persistence of carcinoma in situ in the breast only and no nodal invasion, Grade 3: Presence of invasive carcinoma with stromal alteration, Grade 4: Presence of invasive carcinoma without modification. Grade 1 response was considered as PCR. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1468508|NCT00717405|Primary|Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification|PCR was assessed at the time of definitive surgery according to Sataloff classification and centrally reviewed by an independent committee under blinded conditions. Pathological response was defined based on the therapeutic response at the primary tumor site and axillary lymph nodes. Primary tumor response criteria were as follows: T-A (Total / near total therapeutic effect), T-B (Subjectively greater than [>] 50 percent [%] therapeutic effect but less than [<] T-A), T-C (<50% therapeutic effect, but effect evident), T-D (No therapeutic effect). Axillary lymph node response: N-A (Evidence of therapeutic effect, no metastases), N-B (No therapeutic effect, no nodal metastases), N-C (Nodal metastasis but evident therapeutic effect), N-D (Nodal metastasis with no therapeutic effect). T-A and N-A or T-A and N-B responses were defined as PCR and all other tumor responses as non-responders. Participants with missing values were considered as non-responders.|From baseline through Week 25 (Up to 6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
1468509|NCT00717366|Secondary|Apparent Terminal Phase Half-Life (t1/2) of MIRCERA|t1/2 was defined as the time (in hours) measured (from all sample collection timepoints [as provided in timeframe]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants evaluable for t1/2 assessments.|||hours||Geometric Coefficient of Variation|Geometric Mean
1468510|NCT00717366|Secondary|Time to Reach Cmax (Tmax) of MIRCERA|Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints [as provided in timeframe]). The median time, among all participants, was reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population.|||hours||Full Range|Median
1468511|NCT00717366|Secondary|Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA|Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau).|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|PK evaluable population. Number of participants analyzed = participants with AUC0-672h assessment at specified time-points.|||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1468512|NCT00717366|Secondary|Maximum Observed Serum Concentration (Cmax) of MIRCERA|Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported.|Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|Pharmacokinetic (PK) evaluable population included all enrolled participants who received at least one dose of study drug and had evaluable PK assessment. Here 'n' signifies number of participants evaluable at specified time-points.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
1468513|NCT00717366|Secondary|Change in Average Reticulocyte Count Between the Baseline and Evaluation Period|A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Reticulocyte values within 21 days after blood transfusion(s) were excluded from analysis. Here, number of participants analyzed = participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time-points.|||10^3 cells/microliter||Standard Deviation|Mean
1468514|NCT00717366|Secondary|Number of Participants With Blood Transfusions||Baseline to Week 20|ITT population.|||participants|||Number
1468515|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL|The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.|||participants|||Number
1468516|NCT00717366|Secondary|Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb|Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21).|Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis. Number of participants analyzed = participants with Hb concentration assessment at specified time-points.|||participants|||Number
1468517|NCT00717366|Primary|Change in Average Hb Concentration Between Baseline and Evaluation Period|A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration.|Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|ITT population. Hb values within 21 days after blood transfusion(s) were excluded from analysis.|||g/dL||Standard Deviation|Mean
1475931|NCT00661999|Secondary|Mean Corpuscular Volume (MCV) Level at Baseline, Week 7 and Week 16|MCV is a measure of the average red blood cell volume.|Baseline, 7 weeks and 16 weeks||||fL||Standard Deviation|Mean
1468520|NCT00717314|Secondary|Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52|Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Week 52|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.|||mL/min||95% Confidence Interval|Mean
1468521|NCT00717314|Secondary|Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])|Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).|Baseline and Weeks 16, 28, and 40|PP population; number (n) = number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
1468522|NCT00717314|Secondary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52|BPAR was graded according to Banff criteria.|Week 52|PP population|||percentage of participants|||Number
1468523|NCT00717314|Secondary|Percentage of Participants With Graft Loss or Death at Week 52|Graft loss was defined for this protocol as re-transplantion or death.|Week 52|PP population|||percentage of participants|||Number
1468524|NCT00717314|Primary|Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%|The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.|Week 52|PP population|||percentage of participants|||Number
1468525|NCT00717288|Secondary|Reversion to Intravenous Insulin for Failure of Glycemic Control|Number of participants who went back on intravenous insulin for failure of glycemic control.|72 hours||||participants|||Number
1468526|NCT00717288|Secondary|Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)|Number of patients with hypoglycemia (defined as glucose <65 mg/dl)|48 hours|Intention to treat (ITT)|||participants|||Number
1468527|NCT00717288|Primary|Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3|Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3|day 2, day 3|intention to treat (ITT)|||participants|||Number
1468528|NCT00717275|Primary|Number of Participants Who Developed Distant Brain Failure at One Year.||1 Year|Data was not analyzed.||||||
1468529|NCT00717249|Primary|Average Contact Lens Wear Time|The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.|6 Months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||time in hours||Full Range|Mean
1468530|NCT00717249|Primary|Visual Acuity|Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
1468531|NCT00717249|Primary|Subject Reported Symptoms|"Subjects were asked Have you experienced any symptoms or problems since your last visit? at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, Dryness, Other, Cloudy/ Blurry / Hazy, Irritation / Discomfort. The percentage of each response across all visits was reported."|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Percentage of Observations|Participants||Number
1468532|NCT00717249|Primary|Slit Lamp Findings|Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.|6 months|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Number of Subject Eyes|Participants||Number
1468533|NCT00717236|Secondary|Change From Baseline in Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 28|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 848 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
1468534|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 28|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 857 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
1468535|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 28|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 856 had observed values at Week 28 and Baseline and are included in this analysis|||mm||Standard Error|Least Squares Mean
1468536|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 28|Change from Baseline in CRP (mg/L) is computed as the ratio of the value at Week 28 divided by Baseline value. A ratio less then 1 indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 851 had observed values at Week 28 and Baseline and are included in this analysis|||mg/L||95% Confidence Interval|Least Squares Mean
1468537|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 28|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 854 had observed values at Week 28 and Baseline and are included in this analysis|||units on a scale||Standard Error|Least Squares Mean
1468538|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 28|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as the value at Week 28 minus the baseline value. A negative value in change from baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1468539|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 28|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 861 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1468540|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1468541|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1468542|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. This analysis was carried out using imputation.|Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1468543|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 28|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1468544|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 28|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 828 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1468545|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 28|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from Baseline is computed as the value at Week 28 minus Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was done using a Mixed Effects Repeated Measures Model (MMRM).|Baseline, Week 28|Of the 954 subjects in the Open Label Set (OLS) 840 had observed values at Week 28 and Baseline and are included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
1468546|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 28|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1468598|NCT00717041|Primary|Participants With Depression by Patient Health Questionnaire - 9|Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.|2 hours||||participants|||Number
1468547|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 28|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1468548|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 28|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS). This analysis was carried out using imputation.|Baseline, Week 28|Since imputation was used, all 954 subjects from the Open Label (OL) Set are included in this analysis|||percentage of subjects|||Number
1468549|NCT00717236|Secondary|European League Against Rheumatism (EULAR) Response at Week 12|EULAR response (good response, moderate response, or no response) is defined based on the present value and improvement from baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive protein)].|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1468550|NCT00717236|Secondary|Time to Sustained American College of Rheumatology 20% (ACR20) Response|The time from randomization to sustained ACR20 response at 2 consecutive visits (at the latest on Week 12).|Baseline up to Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1468551|NCT00717236|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS) at Week 12|Change from Baseline in PhGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (827 CZP, 202 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
1468552|NCT00717236|Secondary|Change From Baseline in Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS) at Week 12|Change from Baseline in PtGADA-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
1468553|NCT00717236|Secondary|Change From Baseline in Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) at Week 12|Change from Baseline in PAAP-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1038 (835 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mm||Standard Deviation|Mean
1468554|NCT00717236|Secondary|Change From Baseline in C-reactive Protein (CRP) at Week 12|Change from baseline in CRP (mg/L) is computed as the ratio of Week 12 value divided by baseline value. A ratio less then 1 indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1046 (841 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
1468555|NCT00717236|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1029 (826 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1468556|NCT00717236|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Week 12|SJC is calculated based on swelling response of 28 joints. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1468557|NCT00717236|Secondary|Change From Baseline in Tender Joint Count (TJC) at Week 12|TJC is calculated based on tenderness response of 28 joints. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1043 (838 CZP, 205 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1468599|NCT00716976|Secondary|Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT)||4 weeks after the last dose of cisplatin||2018-01-31|01/2018||||
1475932|NCT00661999|Secondary|Ferritin Level at Baseline, Week 7 and Week 16||Baseline, 7 weeks and 16 weeks||||µg/L||Standard Deviation|Mean
1468558|NCT00717236|Secondary|CDAI (Clinical Disease Activity Index) Remission (≤2.8) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1468559|NCT00717236|Secondary|SDAI (Simplified Disease Activity Index) Remission (≤3.3) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1468560|NCT00717236|Secondary|DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] Remission (<2.6) at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity.|Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1468561|NCT00717236|Secondary|Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis.|||units on a scale||Standard Deviation|Mean
1468562|NCT00717236|Secondary|Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in cm), and Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS in cm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1024 (824 CZP, 200 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1468563|NCT00717236|Secondary|Change From Baseline in DAS28(CRP) [Disease Activity Score-28 (C-reactive Protein)] at Week 12|DAS28(CRP) is calculated using tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/L), and Patient’s Global Assessment of Arthritis-Visual Analog Scale (PtGADA-VAS in mm). A lower score indicates less disease activity. Change from baseline is computed as Week 12 value minus baseline value. A negative value in change from baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS) 1037(834 CZP, 203 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.|||units on a scale||Standard Deviation|Mean
1468564|NCT00717236|Secondary|American College of Rheumatology 70% (ACR70) Response at Week 12.|ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1468565|NCT00717236|Secondary|American College of Rheumatology 50% (ACR50) Response at Week 12|ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects in the Full Analysis Set (FAS) are included in this analysis.|||percentage of subjects|||Number
1468566|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration ≥ 2 Years.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 807 were in the disease duration greater than or equal to 2 years stratum (645 CZP, 162 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1468567|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Disease Duration < 2 Years|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 256 were in the disease duration less than 2 years stratum (206 CZP, 50 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1468963|NCT00714168|Secondary|Physical Activity|Change in Physical Activity from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.|||kcal/week||95% Confidence Interval|Least Squares Mean
1468568|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 663 were in the no prior anti-tumor necrosis (anti-TNF) use stratum (531 CZP, 132 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1468569|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Prior Anti-tumor Necrosis (Anti-TNF) Use|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 400 were in the prior anti-tumor necrosis (anti-TNF) use stratum (320 CZP, 80 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1468570|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects Without Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 331 were in the no concomitant methotrexate use stratum (262 CZP, 69 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1468571|NCT00717236|Secondary|American College of Rheumatology 20% (ACR20) Response at Week 12 for Subjects With Concomitant Methotrexate (MTX) Use.|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|Of the 1063 subjects in the Full Analysis Set (FAS), 732 were in the concomitant methotrexate use stratum (589 CZP, 143 Placebo) and are included in this analysis.|||percentage of subjects|||Number
1468572|NCT00717236|Primary|American College of Rheumatology 20% (ACR20) Response at Week 12|ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient’s Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient’s Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician’s Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)|Baseline, Week 12|All 1063 subjects (851 CZP, 212 Placebo) included in the Full Analysis Set (FAS) are included in this analysis|||percentage of subjects|||Number
1468573|NCT00717197|Primary|Percentage of Participants With Progression-free Survival.|Gadolinium-contrasted MRIs were used to assess radiographic response every 2 cycles (~6 weeks). Tumor progression was defined by increasing tumor size, new areas of tumor, or unequivocal neurologic deterioration.|From date of first dose of study drug until month 6.|Per protocol|||percentage of participants with PFS6||95% Confidence Interval|Number
1468574|NCT00717093|Secondary|Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)|Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL.|Week 12, Week 26|ITT|||participants|||Number
1468575|NCT00717093|Secondary|Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco|Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26.|Week 26|ITT|||participants|||Number
1468576|NCT00717093|Secondary|Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use|Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL.|Week 9 through 12, Week 26|ITT|||participants|||Number
1468577|NCT00717093|Primary|Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco|"Number of subjects who reported no use of nicotine-containing products by answering No to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL."|Weeks 9 through 12|Intent to treat (ITT)|||participants|||Number
1468578|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum EGC QTC, QTCB and QTCF Intervals|Single 12-lead ECG: number of subjects with maximum QTC interval, maximum QTCB interval (Bazett's correction), and maximum QTCF interval (Friderica's correction) measured in milliseconds (msec); range: 450 to <480 msec, 480 to <500 msec, and >500 msec. Maximum QTC interval increase from Baseline; citeria: change = ≥ 30 msec to < 60 msec, and change = ≥ 60 msec.|Normal renal function: screening, Day -3 and Day -1; normal renal function, mild and moderate RI: Day 7 to Day 9 and follow-up; severe RI: screening, Day 1, Day 3, Day 4, and follow-up; ESRD: screening, Day 1, Day 3, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.|||subjects|||Number
1468964|NCT00714168|Primary|Weight Loss|Change in Weight from Baseline|Measured at Month 18|We used an intention-to-treat analysis with all randomized subjects included in the analysis.|||kg||95% Confidence Interval|Least Squares Mean
1468579|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Pulse Rate < 40 and > 120 Beats Per Minute|Number of subjects with pulse rate < 40 beats per minute (BPM), number of subjects with pulse rate > 120 BPM.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication.|||bpm|||Number
1468580|NCT00717067|Secondary|Safety and Tolerability of Maraviroc in the Absence and Presence of a Potent CYP3A4 Inhibitor in Subjects With Various Degrees of Renal Impairment or Undergoing Hemodialysis: Number of Subjects With Maximum Increase and Decrease in Supine Blood Pressure|Number of subjects with absolute values of supine systolic blood pressure (BP) measured in millimeters of mercury (mm/Hg), range: <90 mmHg; and supine diastolic blood pressure, range: <50 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine systolic BP ≥ 30 mmHg. Number of subjects with a maximum increase and decrease from Baseline in supine diastolic BP ≥ 20 mmHg.|Normal renal function: screening, Day -3 to Day -1; normal, mild and moderate RI: Day 7 to Day 10 and follow-up; severe RI: Day 1 to Day 4 and follow-up; ESRD: Day 1, Day 4, and follow-up|Safety analysis set: all subjects who received study medication. BL: Baseline.|||subjects|||Number
1468581|NCT00717067|Secondary|Hemodialysis Clearance of Maraviroc (MVC) in Subjects With End Stage Renal Disease (ESRD) Undergoing Hemodialysis: CLdD|CLdD: dialysate clearance before dialysis; measured in milliliters per minute.|Before dialysis|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mL/min||Standard Deviation|Geometric Mean
1468582|NCT00717067|Secondary|Derivation of Renal Clearance in Subjects With Normal, Mild, Moderate and Severe Renal Function: Ae|Ae: amount of drug excreted unchanged in the urine; measured in milligrams (mg).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mg||Standard Deviation|Mean
1468583|NCT00717067|Secondary|Renal Clearance (CLR) in Subjects With Normal, Mild, Moderate and Severe Renal Function|Renal clearance (CLR) measured in milliliters per minute (mL/min).|Hour 0 (prior to MVC dosing [single dose] or prior to last MVC dose [multiple dose]) to 72 hours post-dose ; hours 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||mL/min||Standard Deviation|Geometric Mean
1468584|NCT00717067|Secondary|Half-life (t1/2)|Elimination half-life (t1/2) measured in hours: time required for half the quantity of maraviroc to be metabolized or eliminated by normal biological processes.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||hour||Standard Deviation|Mean
1468585|NCT00717067|Secondary|Time of First Occurrence (Tmax)|Time (hours) of first occurrence (Tmax); time after dosing when Cmax (maximum plasma concentration) occured.|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||hours||Full Range|Median
1468586|NCT00717067|Secondary|Area Under the Time Curve From 0 to Infinity (AUCinf)|Area under the plasma concentration-time profile from time zero to the time infinate in subjects who received single dose treatment; measured in nanograms * hour divided by millilters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUC infinity was not determined for subjects in the multiple dose treatment groups.|||ng*hr/mL||Standard Deviation|Geometric Mean
1468587|NCT00717067|Secondary|Plasma Protein Binding|Percent protein binding (protein unbound maraviroc (MVC) fraction [percent free]) was determined by rapid equilibrium dialysis. Percent free = 100 - percent bound.|2 hours post-dose; normal Day -3 and Day 7; mild moderate: Day 7; severe and ESRD: Day 1|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||percent free|||Number
1468588|NCT00717067|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) within the dosing interval; measured in nanograms per milliliter (ng/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||ng/mL||Standard Deviation|Geometric Mean
1468589|NCT00717067|Primary|AUCtau|AUCtau: area under the plasma concentration-time profile from time zero to the end of the dosing interval (tau); measured in nanograms * hours divided by milliliters (ng.hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest. AUCtau for end stage renal disease subjects was not determined.|||ng*hr/mL||Standard Deviation|Geometric Mean
1468590|NCT00717067|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) measured in nanograms * hour divided by milliliters (ng*hr/mL).|Pre-dose, post-dose hours 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72.|Pharmacokinetic (PK) parameter analysis population: all subjects treated who have at least 1 of the PK parameters of interest.|||ng*hr/mL||Standard Deviation|Geometric Mean
1468591|NCT00717054|Secondary|Need for Antiemetic Medication||24 hours postoperatively||||participants|||Number
1468592|NCT00717054|Secondary|Total Vomiting||24 hours postoperatively||||participants|||Number
1468593|NCT00717054|Secondary|Number of Participants With Nausea and Vomiting in PACU||Postoperatively, up to 2 hours||||participants|||Number
1468594|NCT00717054|Primary|Number of Participants With Nausea and Vomiting||24 hours postoperatively||||participants|||Number
1468595|NCT00717041|Secondary|Depression and Cognitive Impairment at 2 Weeks|For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.|2 weeks||||participants||95% Confidence Interval|Number
1468596|NCT00717041|Primary|Participants With Anxiety by Generalized Anxiety Disorder - 7|Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.|2 hours||||participants|||Number
1468600|NCT00716976|Secondary|Overall Survival (OS)|Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.|4 Years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.|||Percentage probability||95% Confidence Interval|Number
1468601|NCT00716976|Secondary|Event-Free Survival (EFS)|Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.|4 years after enrollment|61 eligible patients were enrolled on the STS arm; 64 eligible patients were enrolled on the observation arm.|||Percentage probability||95% Confidence Interval|Number
1468602|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 8000 hz|Mean change in hearing threshold (post-pre) at 8000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 8000 hz; 42 patients in the observation arm had paired audiometry at 8000 hz.|||Decibels||Standard Deviation|Mean
1468603|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 4000 hz|Mean change in hearing threshold (post-pre) at 4000 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 4000 hz; 47 patients in the observation arm had paired audiometry at 4000 hz.|||Decibels||Standard Deviation|Mean
1468604|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 2000 hz|Mean change in hearing threshold (post-pre) at 2000 hz|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 2000 hz; 47 patients in the observation arm had paired audiometry at 2000 hz.|||Decibels||Standard Deviation|Mean
1468605|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 1000 hz|Mean change in hearing threshold (post-pre) at 1000 hz.|4 weeks after last dose of cisplatin|37 eligible patients in the STS arm had paired audiometry at 1000 hz; 47 patients in the observation arm had paired audiometry at 1000 hz.|||Decibels||Standard Deviation|Mean
1468606|NCT00716976|Secondary|Change in Hearing Thresholds For Key Frequencies at 500 hz|Mean change in hearing threshold (post-pre) at 500 hz.|4 weeks after last dose of cisplatin|38 eligible patients in the STS arm had paired audiometry at 500 hz; 45 patients in the observation arm had paired audiometry at 500 hz.|||Decibels||Standard Deviation|Mean
1468607|NCT00716976|Primary|Incidence of Hearing Loss|Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.|4 weeks after last dose of cisplatin|55 eligible patients enrolled on the observation Arm had complete audiometry data for evaluation; 49 eligible patients enrolled on the STS arm had complete data audiometry for evaluation.|||Patients|||Number
1468608|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||24 hours methacholine and sputum|||||||
1468609|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)||sputum @ 7 hours|||||||
1468610|NCT00716963|Secondary|The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).||Before inhalation both evaluations (0 hours)|||||||
1468611|NCT00716963|Primary|The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.||7 hours after challenge|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.|||percentage fall FEV1||Standard Deviation|Mean
1468612|NCT00716963|Primary|The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.||Before inhalation 3 hours|Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.|||percentage fall FEV1||Standard Deviation|Mean
1468613|NCT00716859|Secondary|Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience|An investigator’s causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as “related to investigational product” for reporting purposes.|Baseline through Week 12|Intent to treat (ITT) population: all participants who were randomized into the study and received at least 1 dose of study medication.|||Percentage of particpants|||Number
1468614|NCT00716859|Secondary|Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12|Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4, and Week 12|Evaluable participants in PP|||Percentage of participants||95% Confidence Interval|Number
1468615|NCT00716859|Secondary|Mean IOP at Week 12|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 12|Evaluable participants in PP|||mmHg||Standard Deviation|Mean
1468616|NCT00716859|Secondary|Mean IOP at Week 4|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 4|Evaluable participants in PP|||mmHg||Standard Deviation|Mean
1468617|NCT00716859|Secondary|Mean IOP at Week 1|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Week 1|PP|||mmHg||Standard Deviation|Mean
1468713|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|From Week 16, Up to Week 32||2018-08-31|08/2018||||
1468618|NCT00716859|Secondary|Mean IOP at Baseline|IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline|PP|||mmHg||Standard Deviation|Mean
1468619|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 12 (Observed)|Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Evaluable participants in PP|||mmHg||Standard Error|Least Squares Mean
1468620|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 4|Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 4|Evaluable participants in PP|||mmHg||Standard Error|Least Squares Mean
1468621|NCT00716859|Secondary|Reduction From Baseline in Mean IOP at Week 1|Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 1|PP|||mmHg||Standard Error|Least Squares Mean
1468622|NCT00716859|Primary|Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)|Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.|Baseline, Week 12|Per Protocol (PP) Population: participants with no major protocol violations who received at least 1 week of study medication and had at least Week 1 IOP measurements. LOCF.|||mmHg||Standard Error|Least Squares Mean
1468623|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468624|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468625|NCT00716820|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468626|NCT00716820|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468627|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468714|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|From Week 16, Up to 32 Weeks||2018-08-31|08/2018||||
1468628|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468629|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468630|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468631|NCT00716820|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468632|NCT00716820|Secondary|Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1468633|NCT00716820|Secondary|Objective Response Rates by c-Kit Mutation Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1468634|NCT00716820|Secondary|Objective Response Rates by KIT Expression Status|Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1468635|NCT00716820|Primary|Objective Response Rate|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1468636|NCT00716820|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468637|NCT00716807|Primary|Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.||20 minute intervals for three hours.|Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.||||||
1468638|NCT00716742|Primary|Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year|Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).|Baseline, 1 Year|Intent-to-treat, which includes all patients who started the study and completed the one-year follow-up visit and whose data was available for this outcome measure.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
1468639|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1469011|NCT00713479|Primary|Diastolic Blood Pressure|Diastolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals||||mm Hg|Time Points|Standard Deviation|Mean
1468640|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468641|NCT00716625|Other Pre-specified|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468642|NCT00716625|Secondary|Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation|The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468643|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468644|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468645|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468646|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468647|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Elderly Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468648|NCT00716625|Secondary|Number of Participants With Treatment-Related Adverse Events in Pediatric Population|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468649|NCT00716625|Primary|Objective Response Rate|Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).|MAX 2 Years|Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.|||Percentage of participants||95% Confidence Interval|Number
1469012|NCT00713479|Primary|Systolic Blood Pressure|Systolic blood pressure is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals|Per protocol|||mm Hg|time points|Standard Deviation|Mean
1468650|NCT00716625|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 2 Years|Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.|||Participants|||Number
1468651|NCT00716482|Secondary|Interobserver Agreement of B Mode Ultrasound and SWE Features|614 benign and 144 malignant breast masses.|performed on the same day, after study completion|Per protocol. One lesion was analyzed per participant. Two independent readers did a qualitative assessment of 7 image parameters (per lesion) using Kappa.|||kappa statistic||95% Confidence Interval|Number
1468652|NCT00716482|Secondary|Intraobserver Reliability of Quantitative SWE Measurements|614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.|performed on the same day, within 2 years from study start date|Per protocol. 758 masses (614 benign and 144 malignant)are analyzed. One lesion was analyzed per participant. 3 acquisitions per lesion were analyzed with the ICC method for 10 different parameters.|||correlation coefficient||95% Confidence Interval|Number
1468653|NCT00716482|Secondary|Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature|614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.|performed on the same day, within 2 years from study start date|Per protocol. One lesion was analyzed per participant.|||participants|||Number
1468654|NCT00716482|Primary|Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics|"Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size.~Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions.~Based on 939 lesions."|2 years|Per protocol. Analysis includes 289 malignant and 650 benign masses. One lesion was analyzed per participant.|||participants|||Number
1468655|NCT00716456|Primary|The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks|To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)|At conclusion of study, up to 24 weeks||||mg/m2 of CETUXIMAB|||Number
1468656|NCT00716443|Secondary|Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds|Number of participants w/ tolerability assessments (erythema, edema, blanching) resulting in adverse events from Baseline to two days after injection of Restylane® into the nasolabial folds|Baseline to two days after injection of Restylane® into the nasolabial folds|Safety|||participants|||Number
1468657|NCT00716443|Secondary|"Number of Participants With Yes/no Answers to Question to Investigator Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure? Day of Injection of Restylane® Into Nasolabial Folds"|"Number of participants with yes or no answers to question asked to investigator on the day of injection of Restylane® into the nasolabial folds Did the topical anesthetics provided adequate anesthesia for the injections of Restylane® into the nasolabial folds procedure?"|Day of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468658|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468659|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after an injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468660|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468661|NCT00716443|Secondary|Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Blinded Evaluator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468662|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) three hours after injection of Restylane® into the nasolabial folds|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1469013|NCT00713349|Primary|Complete Wound Closure|Each subject acting as their own control|21 Days||||days||Standard Deviation|Mean
1468663|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator's Evaluation of Subject's Pain scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) one hour after injection of Restylane® into the nasolabial folds|one hour after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468664|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) immediately after injection of Restylane® into the nasolabial folds immediately after injection of Restylane® into the nasolabial folds|immediately after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468665|NCT00716443|Secondary|Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds|Number of participants in each category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment scale (0 = No pain; 1 = Slight pain; 2 = Moderate pain; 3 = Severe pain) upon first needle stick of an injection of Restylane® into the nasolabial folds|Upon first needle stick of injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468666|NCT00716443|Secondary|"Number of Participants Who Answered the Question Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member? 3 Hours After Injection of Restylane® Into Nasolabial Folds"|"Number of participants who answered No, Yes or No response to the question Still speaking to the topical anesthetic you had on the right/left side of your face, would you recommend it to your friend or family member? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468667|NCT00716443|Secondary|"Number of Participants Who Answered the Question If it Was Different Than What You Expected, Was it? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered the question If it was different than what you expected, was it? (More pain, Less pain or No response) three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468668|NCT00716443|Secondary|"Number of Participants Who Answered the Question If You Experienced Pain, Was it What You Expected From the Injection Procedure? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered No, Yes, Had no expectations or No response to the question If you experienced pain, was it what you expected from the injection procedure? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468669|NCT00716443|Secondary|"Number of Participants Who Answered the Question What Level of Pain Did You Experience When You Were Injected? Three Hours After Injection of Restylane® Into the Nasolabial Folds"|"Number of participants who answered according to a scale of None, Minimal, Mild, Moderate, Severe, or No response to the question What level of pain did you experience when you were injected? three hours after injection of Restylane® into the nasolabial folds"|three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||participants|||Number
1468670|NCT00716443|Primary|Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds|Subject's pain as evaluated using a VAS scale from 0 - 10 cm (centimeters) with 0 cm being no pain and 10 cm being the worst pain imaginable upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds|ITT (Intent to Treat), LOCF (Last Observation Carried Forward)|||centimeters||Standard Deviation|Mean
1468671|NCT00716417|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum concentration of afatinib in plasma at steady state|0.05hours (h) before administration and 1h, 2h, 2h 55 minutes (min), 4h, 4h 30min, 5h, 6h, 8h, 10h, 24h, 48h, 216h, 480h after administration|The pharmacokinetic analysis set includes all patients who took at least one dose of trial medication and provided at least one blood sample following drug administration. Values were excluded from descriptive statistics when a comparison with plasma concentrations in the same treatment group was impossible.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1468672|NCT00716417|Secondary|Number of Patients With Objective Response|Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.0. Objective response is defined as complete response (CR) and partial response (PR).|Tumor assessment were performed at screening and every 2nd cycle until end of follow up (=end of treatment + 30 days +/- 7 days)|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
1468673|NCT00716417|Primary|Maximum Tolerated Dose (MTD) for Regimen A and Regimen B|The MTD was determined using a standard 3 +3 dose escalation cohort design. The sample size and the number of patients who receive each dose in this design depends on the frequency of DLT at each dose level in cycle 1.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||mg/m^2|||Number
1468674|NCT00716417|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|Number of participants with DLT in the first cycle (21 days) for the determination of the MTD.|21 days|Treated Set (TS) - TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Participants|||Number
1475933|NCT00661999|Secondary|Soluble Transferrin Receptor (sTfR)Level at Week 1, Week 7 and Week 16||1 week, 7 weeks and 16 weeks||||mg/L||Standard Deviation|Mean
1468675|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.|||units on a scale||Standard Error|Least Squares Mean
1468676|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction."|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1468677|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Healthy Participants|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.|||participants||Standard Deviation|Mean
1468678|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1468679|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Healthy Participants|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.|Baseline, 32 Weeks|All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Deviation|Mean
1468680|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.|Baseline, 32 weeks|All healthy participants who had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1468681|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 32 Weeks|All healthy participants who had baseline and post-baseline WJ III measurements.|||units on a scale||Standard Deviation|Mean
1468682|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.|||units on a scale||Standard Error|Least Squares Mean
1468693|NCT00716274|Secondary|The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia|The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|16 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1468683|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction."|Baseline, 16 Weeks|All participants who had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1468684|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Healthy Participants|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Deviation|Mean
1468685|NCT00716274|Secondary|Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1468686|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Healthy Participants|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills.|Baseline, 16 weeks|All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Deviation|Mean
1468687|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1468688|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills.|Baseline, 16 Weeks|All healthy participants who had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Deviation|Mean
1468689|NCT00716274|Secondary|Number of Participants With Adverse Events|Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|32 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1468690|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.|The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|From Week 16 Up to Week 32|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1468691|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With Dyslexia|The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|From 16 Weeks Up to Week 32|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1468692|NCT00716274|Secondary|The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.|The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|16 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
1469357|NCT00711009|Secondary|Mean Change From Baseline in Cholesterol (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1468694|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468695|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468696|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468697|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468698|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468699|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468712|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|From Week 16, Up to Week 32||2018-08-31|08/2018||||
1469351|NCT00711009|Secondary|Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
1468700|NCT00716274|Secondary|Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468701|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468702|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468703|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468704|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468705|NCT00716274|Secondary|Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1469352|NCT00711009|Secondary|Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||milliliters/second||Standard Deviation|Mean
1468706|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468707|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468708|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468709|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468710|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to Week 32|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1468711|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|From Week 16, Up to 32 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.|||units on a scale||Standard Error|Least Squares Mean
1475934|NCT00661999|Secondary|C-reactive Protein (CRP) Level at Week 1, Week 7 and Week 16||1 Week, 7 Weeks and 16 Weeks||||mg/L||Standard Deviation|Mean
1468715|NCT00716274|Secondary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|From Week 16, Up to Week 32||2018-08-31|08/2018||||
1468716|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468717|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468718|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age."|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468719|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age."|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468720|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468721|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468734|NCT00716274|Secondary|Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.|||units on a scale||Standard Error|Least Squares Mean
1468722|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468723|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468724|NCT00716274|Secondary|Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468725|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468726|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468727|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468766|NCT00716092|Secondary|Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).|Baseline and day 28|The pharmacodynamic set (PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo, further restricted to patients who had a baseline and at least one on-treatment value for Glucose AUEC(0-3h). Sitagliptin results from model with all 3 groups.|||mg*h/dL||Standard Error|Mean
1468728|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468729|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468730|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468731|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468732|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468733|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age.|Baseline, 32 Weeks|All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.|||units on a scale||Standard Error|Least Squares Mean
1468767|NCT00716092|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for FPG. Sitagliptin results are from model containing all 3 groups|||mg/dL||Standard Error|Mean
1468735|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone|"The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to ADD possible but not likely. Scores of 40-54 equate to ADD probable but not certain. Scores of 55-120 equate to ADD highly probable. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction."|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1468736|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
1468737|NCT00716274|Secondary|Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
1468738|NCT00716274|Secondary|Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone|WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.|||units on a scale||Standard Error|Least Squares Mean
1468739|NCT00716274|Secondary|Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1468740|NCT00716274|Secondary|Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone|The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.|||units on a scale||Standard Error|Least Squares Mean
1468741|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
1468742|NCT00716274|Secondary|Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
1468743|NCT00716274|Secondary|Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone|The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.|||units on a scale||Standard Error|Least Squares Mean
1468744|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1468745|NCT00716274|Secondary|Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1468746|NCT00716274|Secondary|Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone|The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.|||units on a scale||Standard Deviation|Mean
1468747|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a baseline and post-baseline WJ III measurement.|||units on a scale||Standard Error|Least Squares Mean
1468748|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a baseline and post-baseline WJ III measurement.|||units on a scale||Standard Error|Least Squares Mean
1469358|NCT00711009|Secondary|Mean Change From Baseline in Total Protein (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
1468749|NCT00716274|Secondary|Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who had a WJ III baseline and post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
1468750|NCT00716274|Secondary|Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia|The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, “ADD possible but not likely”. 40-54 equate to, “ADD probable but not certain”. 55-120 equate to, “ADD highly probable”. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.|||units on a scale||Standard Error|Least Squares Mean
1468751|NCT00716274|Secondary|Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant’s word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Error|Least Squares Mean
1468752|NCT00716274|Primary|Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia|The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.|Baseline, 16 weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.|||units on a scale||Standard Error|Least Squares Mean
1468753|NCT00716274|Primary|Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone|WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests—Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.|||units on a scale||Standard Error|Least Squares Mean
1468754|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|Baseline, 16 Weeks||2018-08-31|08/2018||||
1468755|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With Attention Deficit Hyperactivity Disorder (ADHD) or ADHD + Dyslexia (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|Baseline, 16 Weeks||2018-08-31|08/2018||||
1468756|NCT00716274|Primary|Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|Baseline, 16 Weeks||2018-08-31|08/2018||||
1468757|NCT00716274|Primary|Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)|For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly will not have access to the processed fMRI data until approximately April 2018.|Baseline, 16 Weeks||2018-08-31|08/2018||||
1468758|NCT00716144|Secondary|PASI75 at Each Post Baseline Visit Except Visit 6|PASI75 success was defined as number of participants who achieved at least 75% reduction in PASI scores at each post baseline visit (Visit 3 to Visit 8) except Visit 6. The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 1 to Week 20 (Visit 3 to Visit 8) except Week 12 (Visit 6)|MITT population.|||Participants|||Number
1468759|NCT00716144|Secondary|Investigator's Global Assessment (IGA) at Each Post Baseline Visit|The IGA was used to assess the overall severity of a participant’s plaque psoriasis at a particular time point and the evaluation took into consideration the three individual characteristics of plaque psoriasis (scaling, plaque elevation, and erythema). The IGA was recorded using a scale that ranged from 0 (clear), 1 = almost clear, 2 = mild, 3 = moderate to 4 (severe) in whole-unit increments; higher scores indicating worse psoriasis. Investigators did not refer to previous evaluations when conducting the IGA assessment. At every study visit, the investigator evaluated each participant’s plaque psoriasis and recorded the one integer grade that best described the average, overall severity of the condition. Investigators were trained not to refer to previous assessments of the IGA, and not to base the IGA scores on any component of the PASI. Individual body regions were not assessed (as in the PASI), but rather a global evaluation for each participant at each visit was determined.|Week 1 to Week 20 (Visit 3 to Visit 8)|MITT population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the MITT Population.|||Participants|||Number
1468760|NCT00716144|Secondary|PASI50 Success (the Reduction in PASI Score at Each Visit of at Least 50 Percent Relative to Visit 2) at Each Post Baseline Visit|PASI50 success was defined as number of participants who achieved at least 50% reduction in PASI scores at each post baseline visit (Visit 3 to 8) compared to Visit 2 (Baseline). The PASI score was determined through evaluation of BSA covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 1 to Week 20 (Visit 3 to Visit 8)|MITT population.|||Participants|||Number
1468761|NCT00716144|Primary|Psoriasis Area Severity Index (PASI)75 Success at Visit 6|PASI75 success at Visit 6 was defined as number of participants who achieved at least 75% reduction in PASI scores at Visit 6 compared to Visit 2 (Baseline). The PASI score was determined through evaluation of body surface area (BSA) covered by plaque psoriasis in four regions (head/neck, upper extremities, trunk and lower extremities). This assessment included a combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale that ranged as 0 (0% involvement), 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89% and 6 = 90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0 = No evidence of sign, 1 = slight evidence of sign, 2 = moderate evidence of sign, 3 = marked evidence of sign and 4 = very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same four regions. PASI score ranged from 0 to 72 in 0.1-unit intervals; higher scores indicating worse psoriasis.|Week 12 (Visit 6)|Modified Intent-to-Treat (MITT) population. MITT population comprised of all randomized participants who took study medication and provided post-Visit 2 efficacy data (i.e., had one on-therapy follow-up visit).|||Participants|||Number
1468762|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for Plasma Glucose AUEC (0-3h).|||mg*h/dL||Standard Error|Mean
1468763|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28|The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for FPG.|||mg/dL||Standard Error|Mean
1468764|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for GLP-1.|||pmol*h/L||Standard Error|Mean
1468765|NCT00716092|Other Pre-specified|Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.|Baseline and day 28|This analysis was based upon the PD-set further restricted to patients who had a baseline and at least one on-treatment value for WMG.|||mg/dL||Standard Error|Mean
1468806|NCT00715884|Secondary|Percentage of Participants Who Experienced Bleeding Complications|Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and “Protocol” definitions.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1468768|NCT00716092|Primary|GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28|The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. Analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one ontreatment value for GLP-1. Sitagliptin results are from model containing all 3 groups.|||pmol*h/L||Standard Error|Mean
1468769|NCT00716092|Primary|Weighted Mean Glucose (WMG) Change From Baseline at Day 28|The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.|Baseline and day 28|The pharmacodynamic set(PD-set) consisted of all randomised patients who were treated with at least one dose of study drug. This analysis was based upon model with only BI 1356 and Placebo groups, further restricted to patients who had a baseline and at least one on-treatment value for WMG. Sitagliptin results are from model containing all 3 groups|||mg/dL||Standard Error|Mean
1468770|NCT00716079|Secondary|Death at 90 Days||90 days||||participants|||Number
1468771|NCT00716079|Primary|A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)||90 days|In the intensive group 12 patients were alive at 90 days but missing data on mRS (required for primary outcome), and 9 patients in the guideline group|||participants|||Number
1468772|NCT00715962|Primary|Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers|Throughout the hospital stay, both the WP and UC patient wore a triaxial accelerometer on the ipsilateral thigh and ankle. The patient’s skin was assessed regularly to assure there is no evidence of irritation. The wireless monitors were used to quantify the amount of mobility that occurs daily for each patient with researchers being blinded to the outcome.|During hospital stay|Only data from those recording days during which sensors were worn for at least 12 hours, defined as a valid day recording, were considered for final analysis. The average out of bed activity (standing or walking) duration over valid days of recording for each person was reported.|||minutes/day||Standard Deviation|Mean
1468773|NCT00715962|Secondary|Life-Space Assessment Score|"The UAB Study of Aging Life-Space Assessment (LSA) is a validated tool that measures mobility and function based on the distance which a person reports moving during the four weeks preceding the assessment. Life-space levels range from within one’s dwelling to beyond one’s town. A life-space composite score is calculated based on life-space level, degree of independence in achieving each level, and the frequency of attaining each level. Scores range from 0 - 120 with higher scores indicating greater community mobility."|4-6 weeks after baseline||||units on a scale||Standard Deviation|Mean
1468774|NCT00715962|Primary|Falls|Patients were asked daily during hospitalization to self-report any falls|18 months||||participants|||Number
1468775|NCT00715949|Secondary|To Establish if Neurocognitive Deficits Exist, and to What Extent, in the Cohort of Hospitalized Pediatric Patients With Minor Traumatic Brain Injury.||study completion|||||||
1468776|NCT00715949|Primary|The Feasibility of Inpatient Bedside Neurocognitive Testing of Pediatric Patients With Minor Traumatic Brain Injury.|In this study, we demonstrated the feasibility of administering a previously validated, computer-based neurocognitive test battery in the inpatient setting. Participation numbers were determined by the ability of the participant to attend to and complete computerized neurocognitive testing while hospitalized with minor traumatic brain injury (MTBI).|Initial testing within 72 hours of injury and subsequent testing at approximately 2-3 weeks after injury. Subjects were offered the opportunity to also undergo testing at 3 months post-injury.|Analysis population includes only subjects who completed computerized neurocognitive tests. 120 subjects began the study, however 4 dropped out because they were unable to complete the first test and were not included in the final number of analyzed participants.|||participants|||Number
1468777|NCT00715910|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1468778|NCT00715910|Secondary|Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)|Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|During the 6-month period following the primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1468779|NCT00715910|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1468780|NCT00715910|Secondary|Number of Subjects With Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1468781|NCT00715910|Secondary|Number of Subjects With Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).|During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.|||Subjects|||Number
1468782|NCT00715910|Secondary|Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|"Vaccine response was defined as:~For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination."|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Subjects|||Number
1468783|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
1468784|NCT00715910|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values|The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.|1 month post primary (naïve control group) and booster vaccination|Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.|||Subjects|||Number
1468785|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 5 years following primary vaccination|Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.|||Subjects|||Number
1468786|NCT00715910|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 3 years following primary vaccination|Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.|||Subjects|||Number
1468787|NCT00715910|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.|From 6 months up to 1 year following primary vaccination|Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.|||Subjects|||Number
1468788|NCT00715910|Secondary|Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations|Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||μg/mL||95% Confidence Interval|Geometric Mean
1468789|NCT00715910|Secondary|Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values|The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1468790|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468791|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468792|NCT00715910|Secondary|hSBA Antibody Titers|Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Titers||95% Confidence Interval|Geometric Mean
1468793|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1468794|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1468795|NCT00715910|Secondary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1468796|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 5 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1468797|NCT00715910|Primary|Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 3 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1468798|NCT00715910|Primary|Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values|hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.|At year 1 persistence|Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.|||Subjects|||Number
1468799|NCT00715884|Secondary|Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.|31-360 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
1468800|NCT00715884|Secondary|Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)|Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.|0-30 days post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure.|||Percentage of participants|||Number
1468801|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)|"Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following:~DEFINITE - Angiographic or pathologic confirmation;~PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent;~POSSIBLE - Any unexplained death > 30 days.~ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
1468802|NCT00715884|Secondary|Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)|Protocol defined Stent thrombosis include both Early and Late Thrombosis. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring > 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure|||Percentage of participants|||Number
1468803|NCT00715884|Secondary|Percentage of Participants Who Experienced Stroke|The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1468804|NCT00715884|Secondary|Percentage of Participants Who Experienced Any Myocardial Infarction (MI)|Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1468805|NCT00715884|Secondary|Percentage of Participants Who Died|Death incidences include both Cardiac and non-cardiac death.|12 months post procedure|All randomized participants who had 12 months follow-up and documented specific events|||Percentage of participants|||Number
1468807|NCT00715884|Secondary|Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants who had diabetes and were followed up for 12 months.|||Percentage of participants|||Number
1468808|NCT00715884|Secondary|Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)|A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|All randomized participants with lesions of more than 1 vessel and were followed for 12 months|||Percentage of participants|||Number
1468809|NCT00715884|Secondary|Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)|MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1468810|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Failure (TVF)|Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1468811|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)|"TVR is defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA."|12 months post procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1468812|NCT00715884|Secondary|Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)|TLR is defined as any “clinically-driven” repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.|12 months post-procedure|Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1468813|NCT00715884|Secondary|Percentage of Participants Who Achieved Procedure Success|Procedure success is defined as achievement of a final diameter stenosis of < 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay.|At procedure during hospital stay|Intent to Treat|||Percentage of participants|||Number
1468814|NCT00715884|Secondary|Percentage of Device Success - All CYPHER® Stents Included|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. All CYPHER® Stents were included if the final residual stenosis was <50%. Non-study CYPHER® Stents were also included.|At procedure|Intent to Treat population.|||Percentage of success|Participants||Number
1468815|NCT00715884|Secondary|Percentage of Device Success - Protocol Definition|Device success is defined as achievement of a final residual diameter stenosis of <50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. Protocol definition: Only protocol-defined study stents were included.|At procedure|Intent to Treat population.|||Percentage of success|Participants||Number
1468816|NCT00715884|Secondary|Percentage of Lesion Success|Lesion success is defined as the attainment of < 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.|At procedure|ITT: All randomized participants regardless whether they received the intervention|||Percentage of success|Participants||Number
1468817|NCT00715884|Primary|Percentage of Participants Who Experienced Target Lesion Failure (TLF)|The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.|12-months post-procedure|Event-specific adjusted intent to treat (ITT) population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure|||Percentage of participants|||Number
1468818|NCT00715793|Secondary|1-year Overall Survival (OS) Rate|Percentage of patients alive at one year (number of patients alive / total number of evaluable (analyzed) patients).|12 months||||percentage of participants|||Number
1468819|NCT00715793|Secondary|Overall Survival (OS)|OS was defined as the time from study entry until the death or date of last contract.|Up to 42 months||||months||95% Confidence Interval|Median
1468820|NCT00715793|Secondary|6-month Progression-free Survival (PFS) Rate||6 months|Patients that either progressed or died by 6 months.|||percentage of participants|||Number
1468821|NCT00715793|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from study entry until the documented radiological or symptomatic progression. Per RECIST v1.0 criteria (assessed by MRI or CT): Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions.|Up to 42 months||||months||Full Range|Median
1469359|NCT00711009|Secondary|Mean Change From Baseline in Albumin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
1468822|NCT00715793|Secondary|Disease Control Rate (DCR)|Using RECIST v1.0 criteria, disease control rate (DCR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD). Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months||||percentage of participants|||Number
1468823|NCT00715793|Primary|Recommended Phase 2 Dose (RP2D) of DAC + TMZ|Toxicity assessments used CTCAE v3.0. Two dose levels were explored in the phase I portion of the study. A modified 3 + 3 ‘up and down’ design was used. Given the knowledge that DAC exhibits its epigenetic effects at 30-fold lower doses than at its maximum-tolerated dose (MTD), escalation of DAC to the MTD was not done.|Up to 26 months||||mg/kg DAC|||Number
1468824|NCT00715793|Primary|Overall Response Rate (ORR)|Using RECIST v1.0 criteria, overall response rate (ORR) was determined by the number of participants with complete response (CR) + the number of participants with partial response (PR) / the number of participants with complete response (CR) + the number of participants with partial response (PR) + the number of participants with stable disease (SD) + the number of participants with progressive disease (PD), multiplied by 100. Per RECIST v1.0 criteria (assessed by MRI or CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response (PR) nor sufficient increase to to qualify for Progressive Disease (PD); PD, 20% increase in the sum if target lesion or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Up to 30 months||||percentage of participants|||Number
1468825|NCT00715793|Primary|Percentage of Participants That Experienced a Dose Limiting Toxicity (DLT)|Dose-limiting toxicities (DLTs) were defined as grade 4 neutropenia or thrombocytopenia which lasts >7 days; grade 3 or 4 febrile neutropenia; grade 3 or greater non-hematological toxic effects.|Up to 26 months|Patients participating in the Phase 1 portion of the study that were treated on a standard “3+3” phase I dose-escalation design who were observed for unacceptable toxicities.|||percentage of participants|||Number
1468826|NCT00715754|Primary|Estimated Fetal Weight Percentile|Estimated fetal weight percentile by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation||||Percentile||Standard Deviation|Mean
1468827|NCT00715754|Primary|Fetal Abdominal Circumference|Fetal abdominal circumference by 2-D ultrasound at 35 weeks gestation.|35 weeks gestation||||cm||Standard Deviation|Mean
1468828|NCT00715754|Primary|Infant Adiposity at 24-72 Hours Following Birth|Adiposity as measured by air displacement plethysmography|24-72 hours following birth||||Percentage of total body weight||Full Range|Mean
1468829|NCT00715741|Secondary|SpO2 Postoperatively|SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.|24 hours after tracheal extubation||||percent saturation||Standard Deviation|Mean
1468830|NCT00715741|Secondary|"Arterial Oxygen Saturation by Pulse Oximetry (SpO2)"|SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%|45 min after tracheal extubation||||percent saturation||Standard Deviation|Mean
1468831|NCT00715741|Primary|Oxygen Requirement|amount of oxygen (LPM) required to maintain SpO2 >90%|24 hours after tracheal extubation||||liters per min||Inter-Quartile Range|Median
1468832|NCT00715741|Primary|Oxygen Requirement to Maintain SpO2>90%|Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.|45 min after emergence (tracheal extubation)||||liters per minute||Inter-Quartile Range|Median
1468833|NCT00715728|Primary|Intraoperative Time Weighted Average Core Temperature|Temperatures during surgery were recorded at 15-min intervals and summarize as time weighted average (TWA) for each patient. The unit of TWA-temperature is °C.|Until the end of surgery, up to 5 hour|Medical University of Vienna adults having major maxillary-facial reconstructive surgery expected to last about 5 h. Most had pectoral flap reconstructions after extensive cancer debridement. We did not study patients with Reynaud’s disease, thyroid dysfunction, insulin-dependent diabetes mellitus, or who were of ASA physical status > 3.|||degrees as measured in Celcius||Standard Error|Mean
1468834|NCT00715728|Primary|The Rate of Core Rewarming Over the Range From 35°C to 37°C.|The primary outcome was the rewarming rate during active heating over a core temperature range from 35°C to 37°C.|Until the end of surgery, up to 5 hour||||degrees Celcius / hr||Standard Error|Mean
1468835|NCT00715676|Secondary|Number of Subjects With at Least 1 Treatment-emergent Adverse Event|To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.|1 year|The participants for this analysis included all randomized subjects who received a dose of study drug.|||Participants|||Number
1468836|NCT00715676|Secondary|Percent Change From Baseline in Serum Bone Markers at Week 26|Percent change from baseline at Week 26|Baseline and Week 26|Analyses were performed using subjects for whom both Baseline and Week 26 samples were available.|||Percent change||Standard Deviation|Mean
1468837|NCT00715676|Secondary|Change From Baseline in Serum Calcium Levels at Week 52|Change in serum calcium value (relative to baseline) at Week 52|Baseline and Week 52|This analysis was done for all subjects for whom both baseline and Week 52 data was available.|||mg/dL||Standard Deviation|Mean
1468838|NCT00715676|Secondary|Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52|Percent change in trochanter BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
1468839|NCT00715676|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52|Percent change in femoral neck BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
1468840|NCT00715676|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52|The percent change in hip BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was conducted on the Full Analysis Set, which included all randomized subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent Change||Standard Deviation|Mean
1468841|NCT00715676|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52|Percent change in lumbar spine BMD (relative to baseline) at Week 52|Baseline and Week 52|This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.|||Percent change||Standard Deviation|Mean
1468842|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 6||||days||Standard Deviation|Mean
1468843|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 3||||days||Standard Deviation|Mean
1468844|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Month 1||||days||Standard Deviation|Mean
1468845|NCT00715650|Primary|Days of Work and Work-related Activity|Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.|Baseline||||days||Standard Deviation|Mean
1468846|NCT00715624|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration for up to 125 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1468847|NCT00715624|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1468848|NCT00715624|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1468849|NCT00715624|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1468850|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1468851|NCT00715624|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1468871|NCT00715403|Primary|Difference From Baseline for Coagulation Parameters|Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||sec||Standard Error|Median
1468852|NCT00715624|Secondary|Change From Baseline in Total Insulin Dose at Week 24|Change was calculated for total insulin dose by subtracting the baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline total insulin dose assessment during on-treatment period.|||units per day||Standard Error|Least Squares Mean
1468853|NCT00715624|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1468854|NCT00715624|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1468855|NCT00715624|Secondary|Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24|Patients recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1468856|NCT00715624|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1468857|NCT00715624|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. LOCF was used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1468858|NCT00715559|Secondary|Systematic Assessment for Treatment Emergent Effects (SAFTEE)|"The SAFTEE is used to measure somatic and other symptoms which may arise during the course of a clinical trial. This is a non-quantitative instrument that does not yield a numeric score. Instead, it provides study subjects the opportunity to check off symptoms listed on a checklist and indicate if the severity of the symptoms is mild moderate or severe. The reported values represent symptoms that were indicated at any point during the 8 week trial at a level of moderate or severe that also represented a change from a baseline-line pre-intervention SAFTEE assessment."|weekly, for 8 weeks|Study participants were assessed for side effects or adverse events with the SAFTEE at each study visit over the 8 week trial.|||symptoms||Standard Deviation|Mean
1468859|NCT00715559|Secondary|Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16)|This is a self-report which measures the level of depression severity. I ranges from 0 (no illness) to 27 (severe illness).|8 weeks||||scale score||Standard Deviation|Mean
1468860|NCT00715559|Secondary|Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I)|"This set of scales measures global improvement in a patient's level of symptoms, without reference to a particular condition (ie depression). GCI-S is a measure of severity, which ranges from 0 (not ill) to 7 (severely ill). CGI-I is a measure of change, with a score of 4 indicating no change, 1 indicating very much improved and 7 indicating very much worse."|8 weeks||||scale score||Standard Deviation|Mean
1468861|NCT00715559|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|This scale measures depression severity. It ranges from a score of 0 to 60, with higher score indicating higher level of depression severity.|8 weeks|Mean MADRS score at end of treatment (LOCF) in 3 participants treated with cysteamine bitartrate.|||scale score||Standard Deviation|Mean
1469360|NCT00711009|Secondary|Mean Change From Baseline in Bicarbonate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1468862|NCT00715520|Secondary|Aim 3: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.||||||
1468863|NCT00715520|Secondary|Aim 3: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|No sufficient data collected.||||||
1468864|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration for rTMS Treatment With Respect to Frequency|Mean peak acceleration for the different frequencies of rTMS treatment (placebo, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||g||Standard Deviation|Mean
1468865|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) for rTMS Treatment With Respect to Frequency|Mean sum of normalized MEP for the different frequencies of rTMS treatment (placebo at 0.1 Hz, 0.1 Hz, 0.25 Hz, 0.5 Hz) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||millivolts||Standard Deviation|Mean
1468866|NCT00715520|Secondary|Aim 2: Mean Peak Acceleration of Wrist Extension Movements With Respect to Pulse|Mean peak acceleration of wrist movements for repeated TMS (rTMS) conditions with respect of the TMS pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||g||Standard Deviation|Mean
1468867|NCT00715520|Secondary|Aim 2: Mean Sum of Normalized Motor Evoked Potentials (MEPs) With Respect to Pulse|Mean sum of normalized MEP for repeated TMS (rTMS) conditions with respect to the pulse (-100, +300, placebo, zero) prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Its amplitude is measured from peak to peak and expressed in mV. Long- lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1(Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 2 participants per protocol.|||millivolts||Standard Deviation|Mean
1468868|NCT00715520|Primary|Aim 1: Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured across study drug conditions prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2) and 60 minutes after the treatment (post-training 3). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol. One subject was not included in the analysis due to corrupt data.|||g||Standard Deviation|Mean
1468869|NCT00715520|Primary|Aim 1: Mean Parameter Estimate for Maximal Motor Evoked Potential (MEPmax) Derived From Stimulus Response Curves (SRC)|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), immediately after the treatment (post-training 1), 30 minutes after the treatment (post-training 2), and 60 minutes after the treatment (post-training 3).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). SRCs were modeled by a 3- parameter sigmoid function and MEPmax was extracted. Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1 (Immediately), Post-Training 2 (30 Minutes), Post-Training 3 (60 Minutes)|Analysis was completed in Aim 1 participants per protocol for the placebo condition. One subject was not included in the analysis due to corrupt data.|||mV||Standard Error|Mean
1468870|NCT00715403|Primary|Difference From Baseline for Electrolytes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||mmol/L||Standard Error|Median
1468872|NCT00715403|Primary|Difference From Baseline for Haematology and Differentials Parameters|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||10^9 /L||Standard Error|Median
1468873|NCT00715403|Primary|Difference From Baseline for Haemoglobin|Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From baseline until end of treatment, up to 991 days|Treated set.|||g/dL||Standard Error|Median
1468874|NCT00715403|Primary|Difference From Baseline for Bilirubin, Creatinine and Glucose|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||mg/dL||Standard Error|Median
1468875|NCT00715403|Primary|Difference From Baseline for Liver Enzymes|Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.|From signing the informed consent until end of treatment, up to 991 days|Treated set.|||U/L||Standard Error|Median
1468876|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5|All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1468877|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4|All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1468878|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3|All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1468879|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2|All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1468880|NCT00715403|Secondary|Progression Free Survival|"Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.~PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.~Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first."|First drug administration (in previous trial) until end of treatment, up to 1230 days|Treated set. Data for category|||percentage of participants|||Number
1468881|NCT00715403|Secondary|Confirmed Objective Response|Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1468882|NCT00715403|Secondary|Clinical Benefit|Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1468883|NCT00715403|Secondary|Unconfirmed Best Objective Response|Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1468884|NCT00715403|Secondary|Unconfirmed Best Overall Response|"Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).~PD = Progressive disease."|Baseline until end of treatment, up to 991 days|Treated set.|||percentage of participants|||Number
1468885|NCT00715403|Secondary|Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)|Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29|Just before drug administration every 28±7 days after day 29|Treated set. No descriptive statistics could be calculated for the dosing groups 50 mg and 200 mg QD; 100 mg and 300 mg BID due to insufficient patients.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1468886|NCT00715403|Secondary|Clinically Relevant Abnormalities for Vital Signs|Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From baseline until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1468887|NCT00715403|Primary|Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1|All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).|From signing the informed consent until final follow-up, up to 991 days|Treated set|||percentage of participants|||Number
1468888|NCT00715390|Primary|Arrhythmias During General Anesthesia in Children||July 1998 through July 2004||||participants|||Number
1468889|NCT00715299|Primary|The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.|Walking speed is a continuous measure descriptive of overall ambulatory function. This is easily captured with a pressure-sensitive walkway. Three of the 30 participants who completed the study had incomplete data sets, so outcomes are reported on an n=27.|Pre and post Treatment||||meters per second||Standard Deviation|Mean
1468890|NCT00715208|Secondary|Number of Patients Who Experienced at Least One Serious Adverse Event||From completion of informed consent through 30 days after the last dose of study drug|Safety Population: Treated patients|||participants|||Number
1468891|NCT00715208|Secondary|Duration of Response|"Time (in months) from the first documentation of a response (CR or partial response [PR]) to the date of first documentation of progressive disease or relapse from complete response.~CR is defined as disappearance of all evidence of disease assessed by CT or PET; PR is defined as regression of measurable disease and no new sites assessed by CT or PET according to the revised International Working Group (IWG) Criteria."|2 years|Responders: CR + PR (Not done for VELCADE R-CAP, only 5 responders)|||Months||95% Confidence Interval|Median
1468892|NCT00715208|Secondary|Percentage of Participants With Progression-free Survival (PFS) at 1 Year|PFS was defined as the time from the first dose to the date of progressive disease (PD)/relapse or death, whichever comes first. For a participant who had not progressed/relapsed or died, PFS was censored at the last response assessment that was stable disease (failure to attain complete response/partial response or PD or better).|Assessed at at the end of Cycle 2, at end of treatment visit, and every 12± 1 weeks for the first year (4 visits) until PD|Safety population: Treated|||percentage of participants|||Number
1468893|NCT00715208|Secondary|Number of Participants With Overall Response (OR)|"OR = Complete Response (CR) + Partial Response (PR)according to the revised International Working Group (IWG) Criteria.~CR is the disappearance of all evidence of disease assessed by CT and PET. PR is the regression of measurable disease and no new sites assessed by CT and PET."|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to PD or death.|||participants|||Number
1468894|NCT00715208|Primary|Number of Patients With Complete Response (CR)|Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.|30 weeks|Response evaluable: measurable disease at baseline, completed first scheduled response evaluation, or do not complete first scheduled response evaluation due to progressive disease (PD) or death.|||participants|||Number
1468895|NCT00715117|Primary|Number of Patients Reporting Side Effects|Using adverse events and laboratory values Safety & toxicity were evaluated between those on placebo for 8 weeks and those on naltrexone for either 8 or 16 weeks.|8 weeks or 16 weeks|The Fisher Exact Test was used to evaluate the number of side effects reported between placebo and naltrexone groups. The Student T-test was used to evaluate the differences between the mena values of laboratory tests.|||participants|||Number
1468896|NCT00715117|Secondary|Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy|IMPACT III was a pediatric Crohn's specific quality of life survey used in this study. It examines five major categories influencing the quality of life in children with Crohn’s disease including bowel symptoms, systemic symptoms, emotional well-being, social well-being, and body image perception. The IMPACT-III uses 5-point Likert scale ranging from 1 to 5 for all answers. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. So an increase in score denotes improved Quality of life.|16 weeks||||units on a scale||Standard Error|Mean
1468897|NCT00715117|Secondary|Pediatric Crohn's Disease Activity Index Score (PCDAI)|"Secondary outcome was efficacy on clinical activity. Mean pretreatment PCDAI scores in patients had moderate to severe disease activity at baseline were compared between those who received placebo for 8 weeks and those who received active experimental drug, naltrexone.~The PCDAI score is a number unit that is calculated from symptoms scores by the subject over a 7-day period prior to the visit, laboratory values, height & weight, and physical exam findings. A score of 10 and under denotes remission. Mild disease (score of 11-30); moderate disease (score of 31-45), a severe disease (scores greater than 45. A decline of 10 points or more is considered response to therapy. The score can range from 0 to >60 Patient must have a PCDAI score of equal or greater than 30 to qualify for this study (i.e., moderate to severe disease)."|Pretreatment and 8 weeks|The power calculations were performed using STPLAN version 4.1. The current investigation was designed as a pseudo-cross over study to increase the number of participants. In the proposed study, it was assumed that 80% would respond to naltrexone and that no more than 25% of the placebo.|||units on a scale||Standard Error|Mean
1468898|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.|||numbers of spots||Standard Error|Mean
1468899|NCT00715104|Secondary|Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups|The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis.|||number of spots||Standard Error|Mean
1468900|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.|The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.|||number of spots||Standard Error|Mean
1468901|NCT00715104|Secondary|Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.|The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).|12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP|Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis.|||numbers of spots||Standard Error|Mean
1468924|NCT00714493|Secondary|Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase|Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase|Week 26||||percentage|||Number
1468902|NCT00715104|Secondary|Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood|Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.|Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||numbers of spots||Standard Error|Mean
1468903|NCT00715104|Secondary|Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood|"Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays.~This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150–7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells."|Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||numbers of spots||Standard Error|Mean
1468904|NCT00715104|Secondary|Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"|||cells/μm2||Standard Error|Mean
1468905|NCT00715104|Secondary|Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster"|||cells/μm2||Standard Error|Mean
1468906|NCT00715104|Primary|Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject|CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.|Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)|"All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster."|||cells/μm2||Standard Error|Mean
1468907|NCT00715078|Primary|Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Baseline, Months 2, 4 and 6.|Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.|||Ratio ofCD54 molecules on BDS65:FP cells||Standard Error|Mean
1468908|NCT00715026|Secondary|Continued Assessment of Implant Survivorship and Incidences of Adverse Events.|A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.|At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years||||adverse events|||Number
1468909|NCT00715026|Primary|Harris Hip Score|The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.|Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years|Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market.|||units on a scale||Standard Deviation|Mean
1468910|NCT00714948|Primary|To Determine the Progression Free Survival Rate at One Year Untreated Patients With Advanced/Metastatic Urothelial Carcinoma Treated With the Combination of Sorafenib, Gemcitabine, and Cisplatin.||conclusion of the study|||||||
1468911|NCT00714870|Primary|Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)|"Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).~Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.~Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30."|one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later|To detect an effect with greater than or equal to 80% power at a 0.05 two sided significant level, we concluded we needed 22 participants completing each group, intervention and control|||units on a scale||Standard Deviation|Mean
1468962|NCT00714168|Secondary|Energy Intake|Change in Energy Intake from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects analyzed.|||kcal/day||95% Confidence Interval|Least Squares Mean
1468912|NCT00714792|Primary|Number of Subjects With Evidence of Bacteria in Urine Sample by Microbiologic Evaluation|Sterile specimens were obtained from subjects. The urethra was prepared with Betadine and an 8Fr urethral catheter passed into the bladder and urine obtained in a sterile container. Bladder washings were obtained after urine was completely emptied from the bladder via the catheter. Saline (60ccs) was used to vigorously irrigate the bladder 2-3 times through the 8 Fr catheter. The bladder washings were then collected and placed in a sterile container. The experimental cultures included 100ml inoculated on Blood Agar, MacConkey Agar and Brucella Blood Agar, incubated for 72 hours at 35-37 C in ambient atmosphere supplemented with 5-8% carbon dioxide. Colonies were counted to quantify the cfu/ml and all growth of any organism was reported. Organisms were then identified using standard microbiologic techniques.|within one week of enrollment|One overactive bladder subject had greater than 100,000 cfu in routine culture and their specimens were excluded from the analysis.|||participants|||Number
1468913|NCT00714714|Primary|Assessment of Facial Irritation and Cutaneous Effects|Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)|cumulative daily weekday scores for two weeks|One panelist terminated treatment on Day 2. Her scores were carried over and the analysis was based on Intention to Treat (ITT).|||Ordinal data treated as interval||Standard Deviation|Mean
1468914|NCT00714688|Secondary|Change in Conners Adult ADHD Rating Scale Self Report Short Version (CAARS-S:S) Total Score|The CAARS-S:S is a 26-item self-report scale that measures symptoms based on the DSM-IV criteria for ADHD. Respondents were asked to rate items pertaining to their behavior/problems using the following 4-point scale (from 0 = Not at all, never; to 3 = Very much, very frequently). The CAARS-S:S total score range is from 0 (best) to 78 (worse). The change in CAARS-S:S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set. It excludes patients for which a baseline value was missing.|||units on a scale||Standard Deviation|Mean
1468915|NCT00714688|Secondary|Clinical Global Impression-Change (CGI-C)|The CGI-C rating scale is used to rate the change in severity of the subject's illness compared to baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.It excludes patients for which either a baseline or end of treatment value was missing.|||units on a scale||Full Range|Median
1468916|NCT00714688|Secondary|Change in Clinical Global Impression-Severity (CGI-S) From Baseline to End of Treatment|The CGI-S rating scale is used to rate the severity of a subject's illness on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe illness). The change in CGI-S was assessed from baseline to end of treatment (week 13 or or last post-baseline assessment)|from baseline to13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.|||units on a scale||Full Range|Median
1468917|NCT00714688|Primary|Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)|The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.|from baseline to 13 weeks|The ITT analysis set (includes all randomized subjects) was considered the primary efficacy analysis set.|||units on a scale||Standard Deviation|Mean
1468918|NCT00714571|Primary|Memory Test Accuracy on Trained Stimuli|Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test|Pre-training, post-training, 1 month|MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study|||Percent correct||Standard Deviation|Mean
1468919|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Weeks 26.|Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 26||||percentage|||Number
1468920|NCT00714493|Secondary|Percent of Patients Who Achieved ACR20 at Week 10|Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient’s assessment of pain visual analog scale (VAS), Patient’s global assessment of disease activity (VAS), Evaluator’s global assessment of disease activity (VAS), Patient’s assessment of physical function as measured by the HAQ disability index, and CRP.|Week 10||||percentage|||Number
1468921|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 26||||scale -3 to 3||Standard Deviation|Mean
1468922|NCT00714493|Secondary|Change From Baseline in Physical Function (HAQ)|Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.|Week 10||||scale -3 to 3||Standard Deviation|Mean
1468923|NCT00714493|Secondary|Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26|Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26|Week 26||||percentage|||Number
1468925|NCT00714493|Primary|Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10|Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.|Week 10|The evaluable population was the subset of the mITT population (included the enrolled patients who received at least 1 dose of study medication) after excluding all 6 patients from Site 8631 where significant trial misconducts were identified.|||Percentage|||Number
1468926|NCT00714389|Primary|Maximal Flow Rate|Maximal uroflow of spontaneous subject voids|March 2008||||mL/sec||Standard Deviation|Mean
1468927|NCT00714389|Primary|Voided Volume|Volume of spontaneous void|March 2008||||mL||Standard Deviation|Mean
1468928|NCT00714311|Secondary|Borderline Symptomatology (DSM-IV Criteria)||1 month|||||||
1468929|NCT00714311|Secondary|Attachment Style and Reflective Function (Adult Attachment Interview, AAI)||1 year|||||||
1468930|NCT00714311|Secondary|Self-assessment of Psychopathology (BDI, STAI, BSI)||1 year|||||||
1468931|NCT00714311|Secondary|Number of Self-harming Acts||1 year|||||||
1468932|NCT00714311|Secondary|Level of Personality Organization (Structured Interview for Personality Organization, STIPO)||1 year|||||||
1468933|NCT00714311|Secondary|Psychosocial Functioning (Global Assessment of Functioning, GAF-Score)||1 year|||||||
1468934|NCT00714311|Primary|Suicidality (Suicide Attempts)||1 year|||||||
1468935|NCT00714311|Primary|Drop-out|Did not finish one year of treatment.|1 year||||participants|||Number
1468936|NCT00714285|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1468937|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination|During a 21 day (Days 0-20) follow-up period after vaccination-|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1468938|NCT00714285|Secondary|Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).|MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
1468939|NCT00714285|Secondary|Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.|Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
1468940|NCT00714285|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
1468941|NCT00714285|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.|Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).|During a 7-day follow-up period (Days 0-6) after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
1468942|NCT00714285|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).|During a 7 day (Days 0-6) follow-up period after vaccination|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
1468943|NCT00714285|Secondary|Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Days 0 and 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1468944|NCT00714285|Secondary|HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains|Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
1468945|NCT00714285|Secondary|Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
1468946|NCT00714285|Primary|Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
1468947|NCT00714259|Primary|Progression Free Survival Post Transplant|Subjects surviving without disease progression 2 years after transplant as evidenced by no new disease showing on radiologic scans and / or bone marrow pathology.|2 years post transplant||||participants|||Number
1468948|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 365 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|365 days post transplant||||participants|||Number
1468949|NCT00714259|Primary|Progressive Free Survival Post Transplant|Subjects surviving without disease progression 180 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|180 days post transplant||||participants|||Number
1468950|NCT00714259|Secondary|Composite Incidence of Acute and Chronic Graft Versus Host Disease||Up to 100 days post transplant.||||participants|||Number
1468951|NCT00714259|Secondary|Number of Participants With Detectable Donor Chimerism at up to 100 Days Post Transplant|Measured by number of participants that have chimerism study results that show the number of donor cells and the number of recipient cells present in the blood after post-transplant lymphocyte infusions continue to be predominately either donor or recipient.|Post transplant up to 100 days post transplant||||participant|||Number
1468952|NCT00714259|Secondary|Non-relapse Treatment Related Mortality|Death related to treatment without relapse within 100 days after transplant|Within 100 days post transplant||||participants|||Number
1468953|NCT00714259|Primary|Progressive Free Survival Post Transplant|subjects surviving without disease progression at 100 days after transplant as evidenced by decreased disease and no new disease showing on radiologic scans and / or bone marrow pathology.|100 days post transplant||||participants|||Number
1468954|NCT00714233|Secondary|Change in Fasting Glucose|Change in fasting glucose concentration by treatment group pre to post intervention|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
1468955|NCT00714233|Secondary|Triglyceride Concentration by Treatment Group|Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
1468956|NCT00714233|Secondary|Change in SHBG|Measurement of SHBG by treatment group pre and post intervention|baseline and 24 weeks||||ratio||Standard Deviation|Mean
1468957|NCT00714233|Secondary|Change in Free Androgen Index (FAI)|Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range.|baseline and 24 weeks|analysis per protocol|||total T/SHBG||Standard Deviation|Mean
1468958|NCT00714233|Secondary|Weight Loss in Lifestyle Intervention Group|In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI|baseline and 24 weeks|Analysis per protocol|||kg/m^2||Standard Deviation|Mean
1468959|NCT00714233|Primary|Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification|The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY|24 week|Analysis was a description of number of recruited subjects.|||participants|||Number
1468960|NCT00714168|Secondary|Body Composition|Change in Percent Body Fat from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis|||percent body fat||95% Confidence Interval|Least Squares Mean
1468961|NCT00714168|Secondary|Cardiovascular Fitness|Change in Minutes to achieve 85% of age-predicted maximal heart rate from Baseline|Measured at Month 18|Intention-to-treat with all randomized subjects included in the analysis.|||minutes||95% Confidence Interval|Least Squares Mean
1468965|NCT00714051|Primary|Number of Participants Who Fell on a Tripping Test|Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.|4 weeks||||participants|||Number
1468966|NCT00713830|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 120 weeks|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.The one patient in the placebo group who received Lixisenatide was analyzed in the Lixisenatide group|||participants|||Number
1468967|NCT00713830|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1468968|NCT00713830|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1468969|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1468970|NCT00713830|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1468971|NCT00713830|Secondary|Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24|The fasting C-peptide and the 2-hour postprandial C-peptide blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. here. number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||nmol/L||Standard Error|Least Squares Mean
1468972|NCT00713830|Other Pre-specified|Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24|The fasting proinsulin-to-insulin ratio and 2-hour postprandial proinsulin-to-insulin ratio were measured during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data imputed using LOCF. Number of patients analyzed=patients with baseline and at least 1 post-baseline proinsulin-to-insulin ratio assessment during on-treatment period and 'n'= patients with baseline and at least 1 post-baseline assessment for the specific category.|||ratio||Standard Error|Least Squares Mean
1469353|NCT00711009|Secondary|Mean Change From Baseline in Triglycerides (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1468973|NCT00713830|Secondary|Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24|The fasting Proinsulin and the 2-hour postprandial Proinsulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
1468974|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin at Week 24|The fasting plasma insulin and the 2-hour postprandial plasma insulin blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||pmol/L||Standard Error|Least Squares Mean
1468975|NCT00713830|Secondary|Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24|The fasting glucagon and the 2-hour postprandial glucagon blood samples were drawn during a standardized meal challenge test (performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period and 'n' = patients with baseline and at least 1 post-baseline assessment for the specified category.|||ng/L||Standard Error|Least Squares Mean
1468976|NCT00713830|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1468977|NCT00713830|Secondary|Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta blood samples were drawn during a standardized meal challenge test (performed in selected sites). HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
1468978|NCT00713830|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1468979|NCT00713830|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1469065|NCT00712725|Secondary|Absence of Phonophobia|Absence of phonophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1468980|NCT00713830|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG blood sample was drawn 2 hours after start of a standardized meal (standardized meal challenge test performed in selected sites). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|Subgroup for standardized meal test in mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1468981|NCT00713830|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-Treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1468982|NCT00713817|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study is presented.|Day 0 -35|The safety analysis set comprised all subjects who received at least one dose of study medication.|||participants|||Number
1468983|NCT00713817|Secondary|Subject Global Impression of Change at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your nerve pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. The number of subjects wo reported an improvement is presented.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1468984|NCT00713817|Secondary|Change From Baseline in Sleep Disruption 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The sleep disruption Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1468985|NCT00713817|Secondary|Number of Subjects With More Than a 20% Loss of Response at the End of Treatment|The percentage change from baseline in mean 0-10 Numerical Rating Scale pain score was calculated. The percentage changes from baseline were classified and the number of subjects with 20% or greater loss of response to treatment (i.e. percent increase from baseline ≥ 20%) is presented.|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1468986|NCT00713817|Secondary|Number of Subjects Who Failed Treatment at the End of the Treatment Period|"Treatment failure was defined as follows:~A. Premature termination of Part B (Randomised-Withdrawal) study medication. All subjects who did not complete at least 28 days on Part B (Randomised-Withdrawal) study medicationOr:~B. An increase in pain, i.e. the mean pain 0-10 Numerical Rating Scale over seven consecutive days after Part B (Randomised-Withdrawal) randomisation had increased by at least 20% from the Part B (Randomised-Withdrawal) randomised treatment baseline."|Day 7 to time of last dose|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1468987|NCT00713817|Secondary|Change From Baseline Neuropathic Pain Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to 35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1468988|NCT00713817|Primary|Change From Baseline in Mean Daily Pain Severity on a 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The pain severity Numerical Rating Scale was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain severity in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of neuropathic pain. A negative value indicates an improvement in pain score from baseline."|Day 0-35|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1468989|NCT00713700|Primary|The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.|The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.|180 days|Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended.|||percentage of participants||95% Confidence Interval|Number
1469361|NCT00711009|Secondary|Mean Change From Baseline in Chloride (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1468990|NCT00713700|Primary|The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.|"The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure~SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event."|180 days|Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up.|||percentage of participants||95% Confidence Interval|Number
1468991|NCT00713661|Secondary|The Secondary Endpoint is the Feasibility of the TachoSil® Application, Assessed by the Investigator.|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording.|Day of surgery|Data are presented for the 25 subjects treated with TachoSil®. They constitute the intention-to-treat (ITT) and the safety analysis set.|||participants|||Number
1468992|NCT00713661|Primary|The Primary Endpoint is the Feasibility of the TachoSil® Application, Reported by the Combined Assessment of the Investigator and External Assessor|Evaluation of feasibility was assessed by investigator after application of the TachoSil® sponge on the anastomosis. A feasible application implied that the entire TachoSil® adhered and covered at least 1cm beyond the margins of the anastomotic line and that if more than one sponge was used, they overlapped by at least 1 cm. The score was assisted by video recording. To ensure an independent assessment, the recording was assessed by an external, blinded assessor. In case of discrepancies between the assessment of the investigator and the assessor, the application was regarded as not feasible.|Day of surgery|"ITT + Safety Analysis Set.~All applications recorded as “not feasible” by external assessor was because he was not able to see it all the way around the anastomosis. The implication is that the primary endpoint was not really reporting the true feasibility, as it was hindered due to technical/practical problems recording the whole anastomosis."|||participants|||Number
1468993|NCT00713648|Secondary|Number of Subjects With rFXIII Antibody Development|Subjects receiving rFXIII were monitored for the development of binding antibodies. Blood sampling was done before administration of trial product at all visits (Visits 1-16 and unscheduled visit)|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - Subjects who received at least one dose of trial product.|||participants|||Number
1468994|NCT00713648|Secondary|Level of FXIII Activity One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Subjects entered a 52-week treatment period of monthly (28±2 days) doses of 35 IU/kg rFXIII. Blood samples for analysis of FXIII activity were drawn at each visit; at dosing visits blood was drawn 1 hour after administration and before administration(corresponding to 28 days after the previous dose). All Dosing Visits are visits where a dose is given (i.e. Visit 2-15 except Visit 3).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.|||U/kg||Standard Deviation|Mean
1468995|NCT00713648|Secondary|Percentage of Subjects Having a Normal Clot Solubility One Hour After rFXIII Administration and 28 Days After rFXIII Administration for All Dosing Visits|Blood samples for clot solubility drawn at each visit (1 hour before and after dose administration). A clot solubility assay was used to screen for FXIII deficiency. The assay is based on the ability of urea to dissolve fibrin clots that have not undergone FXIII-induced stabilization. Normal blood clots generally remain stable for 24 hours or more, while clots in which fibrin molecules have not been cross-linked are soluble within minutes. The outcome of the test is normal (FXIII present; a clot is observed in the test tube) or abnormal (FXIII absent or very low level; no clot in test tube).|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product. For All Dosing Visits, the participants analyzed (N) are the 'All Visit Subjects Count' i.e. the sum of subject counts across all dosing visits combined.|||percentage (%) of subjects|||Number
1468996|NCT00713648|Primary|Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period|It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product.|For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16).|Full analysis set - consisting of a total of 41 subjects who received at least one dose of trial product.|||bleeding episodes per subject per year||Full Range|Mean
1468997|NCT00713609|Secondary|Proportion of Participants With an ISGA Score of 0 or 1 at Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Week 12|ITT Analysis Set|||Percentage of participants|||Number
1469009|NCT00713479|Secondary|Depression|Using the Beck Depression Index (BDI-II), depression was assessed on a daily basis. The daily mean score during the medication intervention period is presented, with a lower score indicating lower reported depression. The scores range from 0–13: minimal depression; 14–19: mild depression; 20–28: moderate depression; and 29–63: severe depression.|Daily||||units on a scale|Total BDI|Standard Deviation|Mean
1469010|NCT00713479|Primary|Heart Rate|Heart rate is evaluated at 15 min intervals under placebo or varenicline in the presence of methamphetamine over 140 minutes post infusion. Data is pooled and the mean and standard deviation are presented.|15 minute intervals||||bpm|Time Points|Standard Deviation|Mean
1468998|NCT00713609|Secondary|Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|ITT Analysis Set|||Percent change||Standard Deviation|Mean
1468999|NCT00713609|Primary|Proportion of Participants With a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12|An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.|Baseline and up to Week 12|ITT Analysis Set|||Percentage of participants|||Number
1469000|NCT00713609|Primary|Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12|The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).|Baseline and up to Week 12|Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.|||Lesion count||Standard Deviation|Mean
1469001|NCT00713596|Primary|Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity|"ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied).~NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem).~Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose"|6 months post operative|||||||
1469002|NCT00713596|Secondary|Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire|At the end of the study standard post operative rhinoplasty photos will be obtained, and the photos will be reviewed by three blinded observers, who are experienced rhinoplasty surgeons. The photos will be presented to the evaluators in a completely random fashion at a single session. These photos will be graded at that time using the same questionnaire used by the operating surgeon. The questionnaire covers bruising, swelling, tenderness, and length, width, hump and tip of nose, with a range 4-40, 4=ideal nose to 40=many postoperative problems and disfigured nose.|6 months postoperative|||||||
1469003|NCT00713583|Primary|Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES)|The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure.|12 weeks of treatment||||cocaine-negative urines||Standard Deviation|Mean
1469004|NCT00713544|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI)|Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months’ treatment, calculated as score at 12 Weeks minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability.|Baseline to 12 Weeks||||Units on a scale||Standard Deviation|Mean
1469005|NCT00713544|Secondary|Disease Activity Score (Based on 28 Joint Count) (DAS28)|Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of disease activity; and ESR) after 12 Weeks’ treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms.|Baseline to 12 Weeks||||Units on a scale||Standard Deviation|Mean
1469006|NCT00713544|Secondary|American College of Rheumatology 70 Response (ACR70)|The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks||||Participants|||Number
1469007|NCT00713544|Secondary|American College of Rheumatology 50 Response (ACR50)|The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks||||Participants|||Number
1469008|NCT00713544|Primary|American College of Rheumatology 20 Response (ACR20)|The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient’s assessment of pain, disease activity and physical function; physician’s assessment of disease activity; and CRP) after 12 Weeks’ treatment.|12 weeks||||Participants|||Number
1469014|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Open-label Treatment (38 Weeks)|"The patient was asked on a scale of ‘0 to 10’ please indicate the average level of your intoxication due to medications over the last 24 hours (0=no intoxication and 10=extreme toxication). A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469015|NCT00713323|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during Part A of the study is presented (including the follow-up period of 28 days following cessation of opel-label treatment).|42 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||participants|||Number
1469016|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Self-rated Health Status Visual Analogue Scale Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469017|NCT00713323|Secondary|Change From Parent Study Baseline in Mean EuroQol-5D Weighted Health State Index Score at the End of Open-label Treatment|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469018|NCT00713323|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|week 38|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||participants|||Number
1469019|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Sleep Quality 0-10 NRS Score at the End of Open-label Treatment (Week 38)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469020|NCT00713323|Secondary|Change From Parent Study Baseline in Mean Neuropathic Pain Scale (NPS) Score at End of Open-label Treatment (Week 38)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469021|NCT00713323|Primary|Change From Parent Study Baseline in Mean Pain 0-10 Numerical Rating Scale (NRS) Score During the Last 4 Weeks of Open-label Treatment|"The average pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|38 weeks|All subjects who received at least one dose of open-label Sativex were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469022|NCT00713310|Secondary|Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT|PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and Week 6|mITT subjects who were randomized & took at least one dose of study medication|||% participants with treatment success|||Number
1469023|NCT00713310|Primary|Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population|PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)|Baseline and 6 weeks|miTT includes subjects who were randomized and took at least one dose of study medication|||% participants with treatment success|||Number
1469063|NCT00712725|Secondary|Sustained Pain Freedom (SPF)|Pain freedom (Grade 0) at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with study medication.|2-24 hours postdose|Full Analysis Set (FAS), which included all randomized participants who met the FAS criteria for PF at 2 hours postdose, and who, between 2-24 hours posedose, either 1) did not have PF at any time, 2) used rescue, or 3) answered the 24 hour recurrence question.|||Participants|||Number
1469106|NCT00712335|Secondary|Sputum Eosinophil Percentages|Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups|24 weeks|We will use ITT and PP protocols for analysis|||percentage of eosinophils||Standard Deviation|Mean
1469024|NCT00713258|Secondary|Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment|"Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person’s functional level is restricted by pain.~ODI scores from 0 = no disability to 100 = maximum disability.~Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status."|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."|||scores on a scale||Standard Deviation|Mean
1469025|NCT00713258|Primary|Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.|The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = “no pain” and 10 = “unendurable pain”).|Baseline and 24 weeks treatment|"The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity."|||points on a scale||Standard Deviation|Mean
1469026|NCT00713219|Primary|Overall Progression-Free Survival (PFS).|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.|conclusion of the study||||Days||Full Range|Mean
1469027|NCT00713206|Secondary|Crestal Bone Regression||four years||2018-12-31|12/2018||||
1469028|NCT00713206|Primary|Integration Success of Implant|Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis|3 year|Number of participants used in analysis selected as per protocol|||participants|Number of implants analyzed||Number
1469029|NCT00712985|Primary|Number of Participants With Urine and Serum NTx and Serum CTx Within Normal Range at 12 Months|17 women with early breast cancer receiving adjuvant Aromatase Inhibitor (AI) therapy were treated with a single 5 mg IV dose of zoledronic acid. Urine and serum NTx and serum CTx were measured at baseline and month 12.|One year||||participants|||Number
1469030|NCT00712959|Other Pre-specified|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL® 10 Years After a Previous Dose|"Solicited Injection Site Reactions: Pain, Erythema, and swelling. Solicited Systemic Reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 - Pain: Incapacitating, : Incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Erythema and Swelling: ≥5 cm; Fever: > 39.0°C, Headache, Malaise, and Myalgia Prevents daily activities."|Day 0 up to Day 7 post-vaccination|Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.|||Participants|||Number
1469031|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Tetanus and Diphtheria Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for Diphtheria was determined by neutralization assay; GMCs for tetanus was determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
1469032|NCT00712959|Other Pre-specified|Geometric Mean Concentrations Against Pertussis Antigens Before and Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) against pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1469033|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response for Each Anti-Pertussis Antibody Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Booster response for each anti-pertussis antibody was defined as a post-vaccination antibody concentration:~≥ 4 x the Lower limit of quantitation (LLOQ), if the pre-vaccination concentration was < LLOQ; or~≥ 4 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ LLOQ but < 4 x LLOQ; or~≥ 2 x the pre-vaccination antibody concentration, if the pre-vaccination concentration was ≥ 4 x LLOQ."|Day 30 post-vaccination|Booster response for each anti-Pertussis antibody was assessed in the per-protocol population.|||Percentage of Particpants|||Number
1469034|NCT00712959|Other Pre-specified|Percentage of Participants Achieving Booster Response of Anti-Tetanus and Anti-Diptheria Following Revaccination With ADACEL® 10 Years After a Previous Dose|"Anti-diphtheria or anti-tetanus booster responses were defined as:~Pre-vaccination antibody concentrations of < 0.1 IU/mL and a post-vaccination levels ≥ 0.4 IU/mL; or a pre-vaccination antibody concentrations of ≥ 0.1 IU/mL to < 2 IU/mL and a 4-fold rise; or pre-vaccination antibody concentrations of ≥ 2.0 IU/mL and a 2-fold response."|Day 30 post-vaccination|Booster Response to Tetanus and Diptheria antigens were assessed in the per-protocol population.|||Percentage of Participants|||Number
1469035|NCT00712959|Primary|Anti-Pertussis Geometric Mean Concentrations Post-vaccination With ADACEL® 10 Years After a Previous Dose|Post-vaccination geometric mean concentrations (GMCs) for pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination|Geometric mean concentrations were assessed in the per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
1469036|NCT00712959|Primary|Percentage of Participants With Seroprotection Against Tetanus and Diphtheria Before and After Revaccination With ADACEL® 10 Years After a Previous Dose|"Diphtheria concentrations were determined by neutralization assay; tetanus concentrations were determined by enzyme-linked immunosorbent assay (ELISA).~Seroprotection was defined as anti-tetanus or anti-diphtheria concentrations ≥ 0.1 IU/mL."|Day 0 (pre-vaccination) and 30 post-vaccination|Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.|||Percentage of Participants|||Number
1469037|NCT00712933|Primary|Number of Participants With Any SLICC/ ACR Damage Index Worsening (Change > 0) From Baseline by Visit|The SLICC/ACR Damage Index was assessed every 48 weeks and at the exit visit as a measure of disease activity. It was developed to assess the accumulated damage since the onset of the disease. The number of participants with worsening in their SLICC/ACR Damage Index score compared with Baseline have been presented. Worsening was defined as a change in score (post-Baseline visit score – Baseline score) > 0. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. For years in which a participant was withdrawn from the study, the exit visit assessment was used in place of the Week 48 assessment for the year. This value was not carried forward through later years. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
1469038|NCT00712933|Primary|Number of Participants With Shifts From Baseline in Prednisone and Other Steroids Dose by Visit|Participants who had improving SLE disease activity for at least 8 weeks, at the investigator’s discretion, the steroid dose was reduced by reduction to 7.5 mg/day. If the participant continued to have stable or improving disease activity after 4 weeks on a reduced dose, then the investigator considered reducing the dose again. Baseline includes extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. Number of participants with shifts from Baseline total daily dose category by visit is summarized.|Up to 9 years|MITT Population|||Participants|||Number
1469039|NCT00712933|Primary|Number of Participants With IgG Values Below the Lower Limit of Normal by Year|Blood samples were collected to evaluate IgG levels at Baseline and at Weeks 12, 24 and 48 during Year 1. From Year 2-9, IgG was evaluated at Week 24 and 48 ; Exit visit and at follow-up visit (up to 8 weeks post last infusion). Number of participants with IgG immunoglobulin values below the LLN at each one year interval are presented. Baseline includes Extension Year 1 Day 0 values for MITT participants treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants treated with Belimumab in the parent study. If a participant had more than one response within a year, then the last response within the year interval (usually the Week 48 assessment) was summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
1469040|NCT00712933|Primary|Number of Participants With Immunogenic Response by Year|Immunogenic response was analyzed using serum samples for anti-belimumab antibody measurements in MITT population. Categories of response are Negative, Transient Positive (+) means single + response that does not occur at the final assessment, and Persistent + means + response that occurs at least 2 consecutive assessments or a single result at the final assessment. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 9 years|MITT Population|||Participants|||Number
1469041|NCT00712933|Primary|Change From Baseline in Immunoglobulin G (IgG) Levels|Immunoglobulin (Ig) parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 Ig parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ig G were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||g/L||Standard Deviation|Mean
1469042|NCT00712933|Primary|Change From Baseline in Bilirubin (Bili) Levels|Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Bili were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||µmol/L||Standard Deviation|Mean
1469043|NCT00712933|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels|Liver function parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 liver function parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in ALT, ALP, AST, GGT and LDH were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||International Units/liter (IU/L)||Standard Deviation|Mean
1469044|NCT00712933|Primary|Change From Baseline in Creatinine (Cr) and Urate at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Cr and Urate were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
1469045|NCT00712933|Primary|Change From Baseline in BUN and Glucose at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN and Glucose were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||mmol/L||Standard Deviation|Mean
1469046|NCT00712933|Primary|Change From Baseline in Albumin (Alb) and Protein (Pro) at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Alb and Protein were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Grams per liter (g/L)||Standard Deviation|Mean
1469047|NCT00712933|Primary|Change From Baseline in Blood Urea Nitrogen/Creatinine (BUN/Cr) at the Indicated Time Points|Other chemistries parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 other chemistries parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in BUN/Cr is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to 9 years|MITT Population|||Ratio||Standard Deviation|Mean
1469048|NCT00712933|Primary|Change From Baseline in Calcium (Ca), Carbon Dioxide (CO2), Chloride, Magnesium (Mg), Phosphate (Phos), Potassium (K), Sodium (Na) at the Indicated Time Points|Electrolytes parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 electrolytes parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Ca,CO2, Chloride, Mg, Phos, K and Na were summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
1469049|NCT00712933|Primary|Change From Baseline in Erythrocytes (Eryth) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Erythrocytes is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Trillions cells per liter||Standard Deviation|Mean
1469050|NCT00712933|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks). Change from Baseline in Hematocrit is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Percentage of blood by volume||Standard Deviation|Mean
1469051|NCT00712933|Primary|Change From Baseline in Hemoglobin (Hg) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Hg is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Gram per liter (g/L)||Standard Deviation|Mean
1469064|NCT00712725|Secondary|Absence of Nausea|Absence of nausea at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1469052|NCT00712933|Primary|Change From Baseline in Platelets (Plt), Lymphocytes (Lymp), Leukocytes (Leu), Eosinophils (Eos), Basophils (Baso), Monocytes (Mono), Neutrophils (Neu), Neutrophils Band Form (NeuBF), Neutrophils Segmented (NeuS) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in Plt, Lymp, Leu, Eos, Baso, Mono, Neu, NeuBF, and NueS are summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 9 years|MITT Population|||Billion cells per liter||Standard Deviation|Mean
1469053|NCT00712933|Primary|Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points|Hematology parameters were assessed at Baseline, Week 4,12,24,36, and 48 during Year 1. From Year 2-9 hematology parameters were assessed at Week 24 and 48 ; Exit visit and at follow-up (up to 8 weeks post infusion). Change from Baseline in APTT and PT is summarized. The Baseline is defined as For Year 1, Day 0 values for MITT participants who were treated with placebo in the parent study, and the last pre-treatment value in the parent study for MITT participants who were treated with belimumab in the parent study. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. NA indicates standard deviation was not calculable for a single data point|Baseline and up to 9 years|MITT Population|||Seconds||Standard Deviation|Mean
1469054|NCT00712933|Primary|SAE Rates by SOC During the Study|SAE rates by SOC adjusting for participants-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent SAEs are summarized. The event rate of an SAE was calculated as the number of events per 100 participant years. Participants years were calculated as = sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by 365). Participants years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to 9 years|MITT Population|||Adverse events per 100 participant years|Subject years||Number
1469055|NCT00712933|Primary|Number of Participants With Serious Adverse Events (SAE)|An adverse event resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important is categorized as SAE. Only treatment-emergent AEs are summarized.|Up to 9 years|MITT Population|||Participants|||Number
1469056|NCT00712933|Primary|AE Rates by System Organ Class (SOC) During the Study|AE rates by SOC adjusting for participant-years on study drug anytime post Baseline are summarized, which included the follow up visits. Only treatment-emergent AEs are summarized. The event rate of an AE was calculated as the number of events per 100 participant years. Participant years were calculated as sum across all participants ([last visit of interval day - first visit of interval day + 1] divided by365). Participant years excluded between study gaps if participant had not started extension study on date of last visit of parent study.|Up to 9 years|MITT Population|||Adverse events per 100 participant years|Subject years||Number
1469057|NCT00712933|Primary|Number of Participants With Adverse Events (AE)|An adverse event is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. This includes worsening (example: increase in frequency or severity) of preexisting conditions. Participants with incidences of any event at any time post-baseline are presented by yearly interval. Only treatment-emergent AEs are summarized.|Up to 9 years|MITT Population|||Participants|||Number
1469058|NCT00712920|Secondary|Change From Baseline on Direct Visual Nasal Exams and 28 Days|Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation|baseline and 28 days|ITT|||Participants|||Number
1469059|NCT00712920|Secondary|Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days|A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.|baseline and 28 Days|ITT|||Units on a Scale||Standard Deviation|Least Squares Mean
1469060|NCT00712920|Secondary|Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days|Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.|baseline and 28 days|ITT|||Scores on a Scale||Standard Deviation|Least Squares Mean
1469061|NCT00712920|Secondary|Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days|"instantaneous (subjects rate how they feel right now) total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day."|baseline and 28 days|ITT|||Scores on a Scale||Standard Deviation|Least Squares Mean
1469062|NCT00712920|Primary|Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.|"Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day~Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate."|baseline and 28 days|ITT|||Scores on a Scale|||Number
1469066|NCT00712725|Secondary|Absence of Photophobia|Absence of photophobia at 2 hours postdose as recorded by patient on paper diary.|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1469067|NCT00712725|Secondary|Pain Relief (PR)|"Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1469068|NCT00712725|Primary|Pain Freedom (PF)|"Reduction of a Grade 2 or 3 severity migraine at baseline to Grade 0 at 2 hours postdose.~Rating of Headache Severity (Scale from Grade 0 to 3):~Grade 0: No pain~Grade 1: Mild pain~Grade 2: Moderate pain~Grade 3: Severe pain"|2 hours postdose|Full Analysis Set (FAS), which included all randomized participants who administered study treatment, had both a baseline severity measurement and at least one postdose efficacy measurement prior to or including the 2-hour time point.|||Participants|||Number
1469069|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1469070|NCT00712673|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1469071|NCT00712673|Secondary|Percentage of Patients Requiring Rescue Therapy During the Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1469072|NCT00712673|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration|Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1469073|NCT00712673|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1469074|NCT00712673|Secondary|Change From Baseline in Beta-cell Function Assessed by Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) at Week 24|Beta cell function was assessed by HOMA-beta. HOMA-beta (% of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HOMA-beta assessment during on-treatment period.|||% of normal beta cells function||Standard Error|Least Squares Mean
1469075|NCT00712673|Secondary|Change From Baseline in Adiponectin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline adiponectin assessment during on-treatment period.|||mcg/mL||Standard Error|Least Squares Mean
1469076|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.|||ng/L||Standard Error|Least Squares Mean
1469077|NCT00712673|Secondary|Change From Baseline in Fasting Glucagon at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucagon assessment during on-treatment period.|||ng/L||Standard Error|Least Squares Mean
1469078|NCT00712673|Other Pre-specified|Change From Baseline in Glucose Excursion at Week 24|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal teat. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1469079|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.|||nmol/L||Standard Error|Least Squares Mean
1469080|NCT00712673|Secondary|Change From Baseline in Fasting C-Peptide at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline C-peptide assessment during on-treatment period.|||nmol/L||Standard Error|Least Squares Mean
1469081|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1469082|NCT00712673|Secondary|Change From Baseline in Fasting Proinsulin at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to last dosing day of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline proinsulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1469083|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Insulin (PPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PPI assessment during on-treatment period|||pmol/L||Standard Error|Least Squares Mean
1469084|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline plasma insulin assessment during on-treatment period.|||pmol/L||Standard Error|Least Squares Mean
1469107|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
1469085|NCT00712673|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1469086|NCT00712673|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to the last dosing day of the study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy.|Baseline, Week 24|Subgroup for standardized meal test (patients from morning injection arms only) as pre-specified in the protocol. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1469087|NCT00712673|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1469088|NCT00712673|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 12 (Week 24) or Day 169 if Visit 12 is not available, and before the introduction of rescue therapy. For a patient to be included in Modified Intent-to-treat (mITT) population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1469089|NCT00712543|Primary|Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.||14 days||||participants|||Number
1469090|NCT00712530|Other Pre-specified|Change in HIV-specific Memory T Cell Responses at Week 48|"HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.~Note, group Single low-dose was measured at 24 weeks, for this group the 48 weeks data is not available"|48 weeks||||PHPC count||Standard Deviation|Mean
1469091|NCT00712530|Secondary|Change in HIV-specific Memory T Cell Responses at Day 28 Compare to Baseline|HIV-specific T cell precursors with high proliferative capacity (PHPC) were quantified as described earlier [Calarota et al. J Immunol 2008]. Gag-, Tat- and Rev-specific T cells were measured representing ca. 25% of HIV epitopes included in DermaVir.|28 days||||PHPC count||Standard Deviation|Mean
1469092|NCT00712530|Secondary|Number of Subjects Having More Than 50 Copies/mL HIV RNA||28 days||||participants|||Number
1469093|NCT00712530|Secondary|Number of Subjects With Detectable Anti-ds Antibody and ANA||28 days||||participants|||Number
1469094|NCT00712530|Secondary|CD4+ T Cell Counts/mm3||28 days||||CD4+ T cell counts/mm3||Standard Deviation|Mean
1469095|NCT00712530|Primary|Grade 3 Adverse Event Related to DermaVir Treatment|Occurrence of at least one grade 3 or higher adverse event including signs/symptoms, laboratory toxicities and clinical events possibly, probably or definitely related to study treatment as judged by the Principal Investigator or the site investigators during the 28 days after DermaVir administration.|28 days||||participants|||Number
1469096|NCT00712348|Primary|Hemoglobin||Every 3 months from Baseline to Month 9||||g/dL||Standard Deviation|Mean
1469097|NCT00712348|Other Pre-specified|Liver Volume|Liver volume measured by MRI|Baseline and 9 months|2 patients were MRI phobic|||mL||Standard Deviation|Mean
1469098|NCT00712348|Other Pre-specified|Spleen Volume|Spleen volume measured by MRI in mL|Baseline and 9 Months|25 patients had spleen volume measured by MRI, 2 were MRI phobic and 3 were splenectomized|||mL||Standard Deviation|Mean
1469099|NCT00712348|Other Pre-specified|Platelet Count||Every 3 months from Baseline to Month 9||||platelets/mm^3||Standard Deviation|Mean
1469100|NCT00712335|Secondary|Sputum RANTES Levels|Week 24 sputum RANTES levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.|||pg/ml||Standard Deviation|Mean
1469101|NCT00712335|Secondary|Sputum Eotaxin Levels|Week 24 sputum eotaxin levels in active treatment groups were measured.|24 weeks|ITT and PP were used for analysis.|||pg/ml||Standard Deviation|Mean
1469102|NCT00712335|Secondary|Sputum IFN-gamma/IL-5 Ratios|Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.|24 weeks|ITT and PP were used for analysis.|||ratio||Standard Deviation|Mean
1469103|NCT00712335|Secondary|Sputum GM-CSF Levels|Week 24 sputum GM-CSF levels in active treatment groups were measured.|24 weeks|We will use ITT and PP for analysis|||pg/ml||Standard Deviation|Mean
1469104|NCT00712335|Secondary|Sputum IL-8 Levels|Week 24 sputum IL-8 levels in active treatment groups|24 weeks|We will ITT and PP protocols for analysis|||pg/ml||Standard Deviation|Mean
1469105|NCT00712335|Primary|Sputum Neutrophil Percentages|Week 24 sputum neutrophil percentages were measured in active treatment groups.|24 weeks|We will be using intention-to-treat and per protocol for analysis.|||percentage of neutrophils||Standard Deviation|Mean
1469108|NCT00712244|Secondary|Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of Surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
1469109|NCT00712244|Secondary|Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy|Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during anterior capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance.|Time of surgery|This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.|||Percentage of participants|||Number
1469110|NCT00712244|Secondary|Intraocular Pressure (IOP)|Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure is between 10 mmHg and 20 mmHg.|1 day after surgery|This data was collected on all subjects attending the visit one day after surgery with the exception of 3 DisCoVisc subjects, 4 DuoVisc subjects, 2 Healon5 subjects, and 1 AmVisc Plus subject.|||mmHg||Standard Deviation|Mean
1469111|NCT00712244|Secondary|Aqueous Signs - Aqueous Cells|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings: 0 - None, 1 - 1 to 5 cells, 2 - 6 to 15 cells, 3 - 16 - 30 cells, 4 - >30 cells.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of participants|||Number
1469112|NCT00712244|Secondary|Aqueous Signs - Aqueous Flare|Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings: 0 - None: No visible flare when compared to the normal eye, 1 - Mild: Flare visible against dark papillary background but not visible against iris background, 2 - Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as teh dark papillary background, 3 - Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.|1 Day after Surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of participants|||Number
1469113|NCT00712244|Secondary|Aqueous Signs - Corneal Edema|Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings: 0 - none; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.|1 day after surgery|This data was collected for all subjects attending the visit one day after surgery.|||Percentage of Participants|||Number
1469114|NCT00712244|Secondary|Percent Gain in Corneal Thickness.|Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness.|1 week and month after surgery|Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus.|||Percent Gain||Standard Deviation|Mean
1469115|NCT00712244|Primary|Corneal Endothelial Cell Loss|Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope.|1 month after surgery||||Percent Change||Standard Deviation|Mean
1469116|NCT00712179|Primary|Diagnostic|"The electromyographic (EMG) gait pattern of stroke survivors was compared with normal pattern using z-scores."|During sessions- 1 day measurement|Individuals with chronic stroke.|||Z-score||Standard Error|Mean
1469117|NCT00712166|Secondary|Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|Spirometry was performed according to American Thoracic Society (ATS) guidelines at each visit. Treatment effect on the relative change from baseline in FEV1 percent predicted at Day 28 (Visit 4) was tested by the ANCOVA model using the ITT analysis set. Baseline FEV1 percent predicted and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF method was used.|||Percent change from baseline||Standard Error|Least Squares Mean
1469118|NCT00712166|Secondary|Change From Baseline in Log10 Pseudomonas Aeruginosa (PA) Colony Forming Units (CFUs) in Sputum at Day 28|Sputum samples were collected at all study visits for quantitative and qualitative culture for PA. Sputum PA density was quantified by logarithm transformation of the CFU value with base 10. Change from baseline in sputum PA density was calculated as the difference between the log10 CFU values at Day 28 (Visit 4) and the baseline value. Missing data was not imputed. Baseline log10 CFU and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
1469119|NCT00712166|Other Pre-specified|The Minimum Concentrations of Aztreonam That Inhibit 50% and 90% of All PA Isolates (MIC50 and MIC90, Respectively)|Aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed. The minimum inhibitory concentration (MIC) is the lowest concentration of antimicrobial agent that inhibits visible growth of a microorganism. The MIC50 and MIC90 for PA is the MIC required to inhibit the growth of 50% or 90% of PA isolates, respectively. Given that there might be multiple PA isolates for each participant, the MIC50 and MIC90 for PA was calculated using the MIC values for all PA isolates. The MIC50 and MIC90 were calculated by treatment group.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo).|||µg/mL|||Number
1469128|NCT00712075|Secondary|Comprehensive Module Test (CMT)|The Comprehensive Module Test (CMT) is an assessment of CBSST skills acquisition in three domains: Communication Skills Test, Problem Solving Test, and Thought Challenging Test. The total CMT score ranges from 0-33. Higher total scores represent higher level of CBSST skills acquisition.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)||||units on a scale||Standard Deviation|Mean
1469120|NCT00712166|Other Pre-specified|Number of Participants Testing Positive for Other Respiratory Pathogens|Sputum/throat swab samples were collected at all visits for quantitative and qualitative culture of Burkholderia species, Stenotrophomonas maltophilia, Achromobacter xylosidans, methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive S. aureus (MSSA), and Aspergillus species. One CFU on the culture from either a sputum or throat swab sample was considered presence of the particular organism.|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Participants|||Number
1469121|NCT00712166|Secondary|Number of Participants Hospitalized During Study|Hospitalization was defined as any hospital admission lasting for more than 1 calendar day that had been recorded as a serious adverse event (SAE) on the electronic case report form (eCRF). Binary variables were defined to indicate whether participants experienced any hospitalization. Number of hospitalizations was summarized by treatment group.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Study participants|||Number
1469122|NCT00712166|Secondary|Number of Participants Using Additional (Nonprotocol-specified) Antipseudomonal Antibiotics During Study|The number of participants requiring additional antipseudomonal antibiotics (oral, intravenous [IV], or by inhalation), the time to use of these antibiotics, and the reasons for use was recorded. A binary variable was defined to indicate whether the participants needed any antipseudomonal antibiotics that were non-study drug via the oral, IV, or inhalation route between Day 0 (Baseline Visit) and Day 42 (Visit 5). Fisher’s Exact Test was implemented on the intent-to-treat (ITT) and per protocol analysis sets to detect treatment effects on need for additional antipseudomonal antibiotics.|Day 0 to Day 42|Analysis based on ITT population (all participants who received at least part of one dose of AZLI or placebo). No imputation methods were used for the analysis.|||Participants|||Number
1469123|NCT00712166|Secondary|Change From Baseline in CFQ-R Physical Functioning Domain Score|The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0 (baseline), 14, 28, and 42 (the last study visit). The endpoint was change from baseline in the physical functioning domain (e.g., ability to walk and engage in physical activities) of the CFQ-R at Day 28 (range of scores: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R physical functioning domain score and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
1469124|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 42|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 42|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
1469125|NCT00712166|Secondary|Change From Baseline in CFQ-R RSS Score at Day 14|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 14|Analysis based on ITT population (all participants receiving at least part of one dose of AZLI or placebo). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.|||Units on a scale||Standard Error|Least Squares Mean
1469126|NCT00712166|Primary|Change From Baseline in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (<18 vs. >=18 years) were included as covariates in the analysis.|Day 0 to Day 28|Analysis on intent-to-treat (ITT) population (received at least part of 1 dose of AZLI/placebo). Missing baseline data not imputed. Missing post-baseline data imputed with worst-case value for participants who withdrew due to an adverse event (AE)/study drug intolerance. Imputation for other missing data was last observation carried forward (LOCF).|||Units on a scale||Standard Error|Least Squares Mean
1469127|NCT00712075|Secondary|Positive and Negative Syndrome Scale (PANSS)|The PANSS is 30 item semi-structured clinical interview designed to assess positive and negative symptoms. The PANSS consists of 7 items on the positive symptom subscale, 7 items on the negative symptom subscale, and 16 items on the general psychopathology subscale. Each item in the subscale is rated from 0 (absence of symptom) to 7 (extreme symptom severity). Scores of each subscale are summed to yield a total score range of 30 (Absence of symptoms) to 210, where higher scores represent more severe symptoms.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)||||units on a scale||Standard Deviation|Mean
1469354|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)||Baseline to Week 96|Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.|||ratio||Standard Deviation|Mean
1469129|NCT00712075|Primary|Independent Living Skills Survey (ILSS)|The ILSS is a self-report measure in an interview format to assess everyday functioning in ten domains: Appearance and Clothing, Personal Hygiene, Care of Personal Possessions, Food Preparation/Storage, Health Maintenance, Money Management, Transportation, Leisure, Job Seeking, and Job Maintenance. Scale ranges from 0 to 1. Subscales are averaged to yield composite score. Higher scores represent a higher level of functioning.|Baseline, at mid-treatment (3-mo), at end-of-treatment (6-mos), and at 6-mo follow-up (12 mos post-baseline)|Due to incomplete ILSS data for one participant in the CBSST group, 25 of 26 participants were included in the analyses for this measure.|||units on a scale||Standard Deviation|Mean
1469130|NCT00712010|Primary|Calculation of the Area Under Curve Over Baseline for Plasma Insulin|The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes from baseline||||nmole/L*min||Standard Error|Mean
1469131|NCT00712010|Secondary|Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids||180 minutes|||||||
1469132|NCT00712010|Primary|Post-prandial Plasma Responses of Glucose Concentrations|The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.|180 minutes|23 subjects were investigated for AUC of glucose calculations|||mmole/L*min||Standard Error|Mean
1469133|NCT00711997|Primary|Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819|Number of Participants Reaching Maximal Tolerated Dose (MTD)|Week 4|All participants had to receive all 4 scheduled treatments and completed the Week 4 assessment|||participants|||Number
1469134|NCT00711997|Secondary|Tumor Resectability|The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.|5 to 6 weeks||||participants|||Number
1469135|NCT00711997|Secondary|Tumor Response|Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment|4 weeks||||participants|||Number
1469136|NCT00711971|Other Pre-specified|Cord Arterial pH|Arterial blood gas analysis of umbilical cord blood|Immediately after birth (collected within the first hour after delivery)|Umbilical cord gases (pH) were sent at the discretion of the delivering physician and so were not available for all participants.|||pH||Standard Deviation|Mean
1469137|NCT00711971|Other Pre-specified|Five Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar.|5 minutes after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.|||units on a scale||Standard Deviation|Mean
1469138|NCT00711971|Other Pre-specified|One Minute Apgar Score|Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar.|1 minute after birth|One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.|||units on a scale||Standard Deviation|Mean
1469139|NCT00711971|Other Pre-specified|NICU (Neonatal Intensive Care Unit) Admissions|Admission to the NICU|6 weeks post delivery|One set of twins in group A|||Participants|||Count of Participants
1469140|NCT00711971|Other Pre-specified|Neonatal Birthweight|Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age.|immediately after birth|Data is provided for all babies on whom delivery weights were available with a set of twins in EPA rich fish oil arm and a delivery elsewhere for whom no birth weight was available for one baby from a mother in the Soy oil placebo arm. Thus there is 1 more participant than mothers participating in the EPA-rich arm and one less in the soy oil arm.|||grams||Standard Deviation|Mean
1469141|NCT00711971|Other Pre-specified|Estimated Blood Loss (ml)||Within 24 hours after delivery||||mL||Standard Deviation|Mean
1469142|NCT00711971|Other Pre-specified|Gestational Age at Delivery (Weeks)||delivery date was assessed by medical record review between 1 day and 8 weeks after delivery|Gestational age is measured based on the pregnancy not the neonates, therefore although there were 40 babies born to the 39 mothers randomized to the EPA-rich fish oil, it is proper to consider the participants analyzed to be the 39 participating mothers. This is clarified still further by identifying the units appropriately as pregnancies.|||weeks|pregnancies|Standard Deviation|Mean
1469143|NCT00711971|Other Pre-specified|Maternal Outcomes|While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery.|visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery|"Gestational hypertension and diabetes were self-reported for all participants so her data is included for those two rows.~One woman in the soy placebo arm delivered out of the geographic area, so documentation of delivery outcome is unavailable for analysis."|||participants|||Number
1469144|NCT00711971|Primary|Beck Depression Inventory|The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)|6 - 8 weeks postpartum|Per protocol analysis is reported here.|||units on a scale||Standard Deviation|Mean
1469145|NCT00711958|Primary|Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia|Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.|5-12 weeks|Intention-to-treat population: patients with post baseline Hemoglobin value available|||Participants|||Count of Participants
1469146|NCT00711880|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1469147|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment|"Subjects were asked to give their impression of the overall change in their allodynia since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’.~A summary of the number and percentage of subjects"|Day 0 - 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1469148|NCT00711880|Secondary|Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment|Intoxication scores were measured using a 100 mm Visual Analogue Scale, where 0 equalled ‘no intoxication’ and 100 equalled ‘extreme intoxication’. A negative value indicates an improvement in intoxication score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469149|NCT00711880|Secondary|Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment|Subjects were asked to give their impression of the overall change in their peripheral neuropathic pain since entry into the study using the following seven-point scale: 1 = ‘Very Much Improved’, 2 = ‘Much Improved’, 3 = ‘Minimally Improved’, 4 = ‘No Change’, 5 = ‘Minimally Worse’, 6 = ‘Much Worse’, 7 = ‘Very Much Worse’. The number of subjects who reported an improvement is presented.|Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
1469150|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||number of words||Standard Deviation|Mean
1469151|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||percentage of correct answers||Standard Deviation|Mean
1469152|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469153|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for ‘10/36 Spatial Recall' at the End of Treatment|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469154|NCT00711880|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469155|NCT00711880|Secondary|Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment|The General Health Questionnaire-12 is designed to measure non-psychotic mental disorders. It consists of 12 questions, scored on a 0 to 3 Likert scale to measure and compare psychological morbidity levels, where 0 represents better psychological health. The total General Health Questionnaire-12 score is the unweighted sum of the 12 scores. Zero indicates the best possible psychological health, 36 indicates the worst possible psychological health.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469168|NCT00711828|Primary|Proportion of Responses (Complete Response or Partial Response)|A response is defined to be a Complete Response (CR) or Partial Response (PR) noted as the objective status on any evaluation (i.e., best response). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A confidence interval for the true success proportion will be calculated according to the properties of the binomial distribution.|up to 12 cycles||||percentage of participants||95% Confidence Interval|Number
1469156|NCT00711880|Secondary|Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment|The static allodynia test involved applying pressure to a non-allodynic area (on the contralateral side to the identified allodynic area), and recording the pressure that caused pain to this area. Seventy five percent of the pressure that caused pain to the non-allodynic area (up to the subject’s pain/pressure threshold) was then applied to the allodynic area, and an 11-point Numerical Rating Scale pain score recorded (between 0 (no pain)and 10 (most intense pain imaginable)). A negative value indicates an improvement in pain score from baseline.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469157|NCT00711880|Secondary|Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5sec intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes. A negative change from baseline indicates an improvement in score.|Day 7 and Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469158|NCT00711880|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment|The Pain Disability Index consisted of seven self-administered questions relating to the effect of the subject’s chronic pain on their personal life (family/home responsibilities, social activity, sexual behaviour, life-support activity, recreation, occupation and self-care). Each assessment was scored on an 11-point Numerical Rating Scale ranging from 0 (which equals ‘no disability’) to 10 (which equals ‘total disability’). The total Pain Disability Index is the unweighted sum of the seven Numerical Rating Scale scores. The maximum (worst) total score was 70.|Day 0 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469159|NCT00711880|Secondary|Change From Baseline in Mean Sleep Quality at the End of Treatment|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 - Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469160|NCT00711880|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale (NPS) score consisted of a series of assessments of different aspects of pain (intensity, sharpness, hot, dull, cold, sensitive, itchy, unpleasantness, and surface compared with deep), each scored using 11-point Numerical Rating Scales. The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469161|NCT00711880|Primary|Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment)|"The neuropathic pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline."|Day 0 to Day 42|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
1469162|NCT00711867|Primary|Sublingual Temperature.||Within 10 minutes of arrival in PACU|Per protocol.|||C||Standard Deviation|Mean
1469163|NCT00711828|Secondary|Adverse Events|Adverse events were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report.|up to 12 cycles (28 days per cycle) of treatment||||participants|||Number
1469164|NCT00711828|Secondary|Time to Treatment Failure|Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1469165|NCT00711828|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented. MR for Waldenstrom lymphoma will not be included as a response. Median duration of response and the confidence interval for the median duration will be computed.|Up to 3 years from registration|Thirteen patients achieved a CR or a PR and are included in this analysis.|||months||95% Confidence Interval|Median
1469166|NCT00711828|Secondary|Progression-free Survival|Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression or death, whichever occurs first. Progression is defines as having any new lesion or increase by 50% of previously involved sites from nadir. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1469167|NCT00711828|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Up to 3 years from registration||||months||95% Confidence Interval|Median
1469169|NCT00711802|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])|"Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points:~Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion."|Predose and 5 timepoints according to age group (up to 12 hours postdose)|Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.|||microgram*hour per milliliter (μg*hr/mL)||Standard Deviation|Mean
1469170|NCT00711802|Secondary|Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit|"The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as Success or Failure by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered Success by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of “Failure” was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was “Failure.” If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was Unable to evaluate."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.|||percentage of participants|||Number
1469171|NCT00711802|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included possibly related or related as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 14 days after last dose of study drug|Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.|||percentage of participants|||Number
1469172|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Legs|Ankle dorsiflexion, knee extension and hip flexion were assessed and scored to give a maximum of 100%. The Motricity Index score (scale 1-100) was recorded for limbs that had an associated Ashworth Scale score, which was greater than or equal to two at baseline.|Day 7 and Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469173|NCT00711646|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who reported an adverse event during the course of the study is presented.|Day 0-52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
1469174|NCT00711646|Secondary|Patient’s Global Impression of Change in Condition at the End of Treatment|A 7-point Likert-type scale was used, with the question: ‘Please assess the change in your condition since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
1469175|NCT00711646|Secondary|Change From Baseline in Mean Motricity Index Score for the Arms|Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. The total arm score was the addition of the score for the 3 arm movements. One point was then added to give a maximum score of 100; minimum was 1 point. Where both arms were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition..|Day 7 and 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469176|NCT00711646|Secondary|Change From Baseline in Mean Spasm Frequency Score at the End of Treatment|Each day subjects recorded in their diary the frequency of their spasms using the following scoring system: 0 = no spasms, 1 = one or fewer spasms per day, 2 = between one and five spasms per day, 3 = six to nine spasms per day, 4 = ten or more spasms per day or continuous contraction. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy.|Days 0 - 52||||units on a scale||Standard Deviation|Mean
1469177|NCT00711646|Secondary|Change From Baseline in Mean Ashworth Scale Score at the End of Treatment|The mean Ashworth Scale score across muscle groups was calculated using only those muscle groups with a score of greater than or equal to two at baseline. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Days 0 - 52|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469212|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
1469178|NCT00711646|Primary|Assessment of Change From Baseline in the Mean Spasticity 0-10 Numerical Rating Scale Score.|"The spasticity Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your average spasticity in the last 24 hours where 0 = no spasticity and 10 = worst ever spasticity. For the analysis, end of treatment was defined as the mean of the last seven days in the study or the last three days if the subject withdrew due to worsening spasticity or lack of efficacy. A negative value indicates an improvement in spasticity score from baseline."|0-52 days|All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
1469179|NCT00711594|Secondary|Phase I Step: Cmax,Cmax,ss of BIBW 2992 After Multiple Oral Administration||Just before start of the treatment to Course 4 Visit 4R2|"The “treated set” of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.Some samples were excluded from the evaluation because these were taken outside the allowed time-windows.~Number of analyzed patients of BIBW 50mg cohort for Cmax,ss: 5"|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1469180|NCT00711594|Secondary|Phase II Step: Summary of EGFR Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1469181|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 15|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 15|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1469182|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course2 Day 1|Outcome data show the gMean of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW|Course 2 Day 1|"Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1469183|NCT00711594|Secondary|Phase II Step: Trough Plasma Concentrations of BIBW2992 After Multiple Oral Administration of BIBW 2992: Treatment course1 Day 15|"Outcome data show the geometric mean (gMean) of trough plasma concentrations of BIBW 2992 after multiple oral administration of BIBW.~The dose determined from the result of the Phase I step (50 mg) will be used. Reduction of dose in accordance to the criteria specified by adverse events to 40 mg or 30 mg was possible."|Course 1 Day 15|Plasma concentrations of BIBW2992 were to be presented for all patients and sampling points with concentrations above the lower limit of quantification. No patient was treated with 30 mg during the Course 1.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
1469184|NCT00711594|Secondary|Phase II Step: Maximum CTC Grade During the Trial for Laboratory Parameters, Among Patients Who Experienced an Increase in CTC Grade From Baseline|outcome data show the number of patients for the maximum CTC grade during the trial for laboratory parameters, among patients who experienced an increase in CTC Grade|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication.~For activated partial thromboplastin time (APTT), N = 59 For Prothrombin Time and International Normalized Ratio (PT-INR), N = 61"|||participants|||Number
1469185|NCT00711594|Secondary|Phase II Step: Safety of BIBW 2992 as Indicated by Intensity and Incidence of Adverse Events, Graded According to CTCAE|outcome data show the number of patients with Adverse events (AE) by intensity and incidence of adverse events, graded according to CTCAE.|Start of treatment to end of treatment (up to 41.3 months) plus 4 week follow-up|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1469186|NCT00711594|Secondary|Phase II Step: Overall Survival (OS)|OS was defined as the duration of time from the start of treatment to the time of death.|from start of treatment until end of follow up, up to 53 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Months||Inter-Quartile Range|Median
1469187|NCT00711594|Secondary|Phase II Step: Progression-free Survival (PFS)|PFS was defined as the duration of time from the start of treatment until the day of objective tumour progression confirmed by tumour imaging (PD according to the RECIST) or death.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Months||Inter-Quartile Range|Median
1469188|NCT00711594|Secondary|Phase II Step: Duration of Clinical Benefit|Presented as duration of disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||Weeks||Full Range|Median
1469189|NCT00711594|Secondary|Phase I Step: Summary of Epidermal Growth Factor Receptor (EGFR) Mutation Findings||Screening visit|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1469258|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 6 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|6 months||||μm||Full Range|Median
1469190|NCT00711594|Secondary|Phase II Step: Duration of Objective Response|Duration of objective response was defined as the time at which RECIST was first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|The “full analysis set” of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started.|||weeks||Full Range|Median
1469191|NCT00711594|Secondary|Phase II Step: Time to Objective Response|Number of participants with first response at week 4, 8 and 12, assessed by investigator and independent review.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||Number of patients|||Number
1469192|NCT00711594|Secondary|Phase II Step: Clinical Benefit|Clinical benefit was defined as a RECIST assessment of complete response, partial response, or stable disease according to the best response to study treatment as defined in the previous section. Clinical benefit presented as the disease control.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation) up to 41.3 months|"The full analysis set of patients was defined as all patients includes in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||percentage of participants||95% Confidence Interval|Number
1469193|NCT00711594|Secondary|Phase I Step: AUC0-24, AUCtau,ss of BIBW 2992 After Multiple Oral Administration|area under the concentration-time curve of BIBW 2992 over the time interval 0-24 hours (AUC0-24), Area under the concentration-time curve of Afatinib in plasma at steady state (AUCtau,ss) after multiple oral administration Pharmacokinetic was abbreviated to PK.|AUC0-24: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00 on Day 1-2 in Course 1; AUCtau,ss: just before drug administration, 0:30,1:00, 2:00, 3:00, 4:00, 5:00, 7:00, 9:00, 24:00, 48:00, 72:00 on Day 28-31 in Course 1|"“Treated set” was defined as all patients who received at least 1 dose of BIBW2992. Some samples were excluded from calculation of descriptive statistics of plasma concentration because these were taken outside the allowed time-windows but used for calculation of PK parameters.~Number of analyzed patients of BIBW 50mg:5(AUCtau,ss), 40mg:2(AUC0-24)"|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
1469194|NCT00711594|Primary|Phase II Step: Objective Tumour Response According to Response Evaluation Criteria in Solid Tumours (RECIST)|The objective response (complete response [CR] and partial response [PR]) was defined as determined by the RECIST according to the best response to study treatment.|Tumour Assessment were performed at screening 14 days (prior to enrollment), in week 4, week 8, week 12 and in 8-week intervals thereafter, and at the end of trial visit (patients discontinuation), up to 41.3 months|"The full analysis set of patients was defined as all patients included in the treated set who have both baseline tumour imaging data and at least one analysable tumour imaging data after BIBW 2992 started."|||percentage of participants||95% Confidence Interval|Number
1469195|NCT00711594|Primary|Phase I Step: Safety of BIBW 2992 Assessed Based on Incidence of Dose Limiting Toxicity (DLT) and Incidence & Intensity of Adverse Events According to CTCAE||start of treatment to end of treatment|"The treated set of patients was defined as all patients who received at least 1 dose of BIBW 2992 medication."|||participants|||Number
1469196|NCT00711555|Secondary|no Significant Nausea|defined as a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
1469197|NCT00711555|Secondary|no Nausea|defined as maximum nausea severity < 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
1469198|NCT00711555|Secondary|no Emesis||cycle 1, day 1||||%|||Number
1469199|NCT00711555|Secondary|Complete Protection|defined as no emesis, no use of rescue medications, and a maximum nausea severity < 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)|cycle 1, day 1||||%|||Number
1469200|NCT00711555|Primary|Complete Response|defined as a no emetic episodes and no use of rescue therapy|cycle 1, day 1||||%|||Number
1469201|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All nine women who initiated hypnotherapy treatment completed the survey at the end of 8 weeks. One woman in the gabapentin arm did not submit a survey at 8 weeks.|Week 8||||units on a scale (HFRDIS)||Full Range|Median
1469202|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten hot flash-related symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). Of 11 eligible women in the hypnotherapy arm, 2 never initiated treatment, and 3 did not complete the survey at this time point. Of the 14 eligible women in the gabapentin arm, 3 never initiated treatment, and 3 dropped out of the study before the 4 week time point.|Week 4||||units on a scale (HFRDIS)||Full Range|Median
1469203|NCT00711529|Secondary|Hot Flash Related Daily Interference Score (HFRDIS)|The HFRDIS is a validated survey of 10 questions asking patients to rate ten symptoms on a scale of 0-10. The HFRDIS is a sum of the scores in each category, so that total score can range from 0 (no symptoms) to 100 (10 severe symptoms). These surveys were conducted at the time of enrollment (baseline), after four weeks of treatment, and at the conclusion of the study (8 weeks). All women who were randomized were included in the baseline analysis (with the exception of 2 women excluded from the hypnotherapy arm who were deemed ineligible after randomization).|Baseline||||units on a scale (HFRDIS)||Full Range|Median
1469204|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 8||||units on a scale (severity score)||Full Range|Median
1469205|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Week 4||||units on a scale (severity score)||Full Range|Median
1469206|NCT00711529|Primary|Hot Flash Severity Score|The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints.|Baseline||||units on a scale (severity score)||Full Range|Median
1469207|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark."|Week 8||||daily hot flashes||Full Range|Median
1469208|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark."|Week 4||||daily hot flashes||Full Range|Median
1469209|NCT00711529|Primary|Number of Daily Hot Flashes|"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries."|Baseline||||daily hot flashes||Full Range|Median
1469210|NCT00711516|Secondary|Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test|During anatomic scanning (and prior to functional runs when anatomic scanning was not performed), a modified continuous 10 minute attention task (“Psychomotor Vigilance Test [PVT]-like task,” nearly identical to the PVT but for absence of performance feedback) was run to obtain a measure of vigilance in the scanner—in this instance, the “+” symbol appeared at random (mean inter trial interval of 5 seconds, range 2 - 10 seconds) but disappeared when subject pressed a button. Subject performance speed was measured. Change in subject performance speed from Baseline to Endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline|||milliseconds (ms)||Standard Error|Least Squares Mean
1469211|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of activated voxels meeting predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the thalamus.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
1469355|NCT00711009|Secondary|Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469213|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels meeting pre-defined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects with at least one observation after Baseline|||Voxels||Full Range|Median
1469214|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the number of contiguous activated voxels (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI) in the dorsolateral prefrontal cortex.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after Baseline|||Voxels||Full Range|Median
1469215|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the thalamus.|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline|||BOLD signal intensity||Full Range|Median
1469216|NCT00711516|Secondary|Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the posterior parietal cortex (PPC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who have had at least one observation after Baseline|||BOLD signal intensity||Full Range|Median
1469217|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent signal (BOLD) intensity in the anterior cingulate cortex (ACC).|Baseline and Endpoint (Week 2 or last observation after Baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline|||BOLD signal intensity||Full Range|Median
1469218|NCT00711516|Secondary|Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State|At resting state, this is an analysis of the change from Baseline to Endpoint in the blood oxygen level dependent (BOLD) signal intensity in the dorsolateral prefrontal cortex (DLPFC).|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one observation after baseline|||BOLD signal intensity||Full Range|Median
1469219|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the thalamus for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1469220|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the posterior parietal cortex (PPC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1469221|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the anterior cingulate cortex (ACC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis of non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1469222|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test|This is a subgroup analysis of non-responders on the 2-back working memory test for the number of voxels meeting the predefined threshold (voxels that differ significantly from reference wave form) on functional magnetic resonance imaging (fMRI). A non-responder in the 2-back working memory test was defined as a patient showing a response latency of 713 ms or greater at endpoint. The change from Baseline to Endpoint in the number of activated voxels in the dorsolateral prefrontal cortex (DLPFC)for each treatment group among the non-responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group analysis among non-responders on the 2-Back Working Memory Test (response latency of 713 ms or greater) at Endpoint|||Voxels||Standard Error|Mean
1469356|NCT00711009|Secondary|Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469223|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (voxels that differ significantly from reference wave form) in the thalamus. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
1469224|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels (voxels that differ significantly from reference wave form) in Posterior Parietal Cortex (PPC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had a response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
1469225|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of activated voxels (that differ significantly from reference wave form) in Anterior Cingulate Cortex (ACC). A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test (had response latency < 713 ms) at Endpoint|||Voxels||Standard Error|Mean
1469226|NCT00711516|Secondary|Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test|This is a subgroup analysis of responders on the 2-back working memory test for the number of voxels meeting the predefined threshold in DLPFC. A responder in the 2-back working memory test was defined as a patient showing a response latency of less than 713 ms at endpoint. This is based on baseline data from the matched control population in a functional imaging study in patients with obstructive sleep apnea. The change from Baseline to Endpoint in the number of activated voxels (that differ significantly from reference wave form) for each treatment group among the responders is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Sub-group Analysis of subjects who were responders on the 2-Back Working Memory Test defined as subjects who had a response latency of < 713 ms at Endpoint|||Activated voxels||Standard Error|Mean
1469227|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between BOLD signal intensity on fMRI in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1469228|NCT00711516|Secondary|Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1469229|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI in the ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1469230|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint|With this outcome measure the correlation between the BOLD signal intensity on fMRI over DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1469231|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in the thalamus versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1469232|NCT00711516|Secondary|Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in PPC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1469233|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in ACC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Week 2 or Last Observation after Baseline|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline|||Correlation Coefficient|||Number
1469234|NCT00711516|Secondary|Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint|With this outcome measure the correlation between the number of voxels activated on fMRI (voxels that differ significantly from reference wave form) in DLPFC versus performance on the 2-back working memory test was evaluated for both Armodafinil and Placebo. Correlation coefficients and P-values are presented for each treatment group.|Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one observation after baseline|||Correlation Coefficient|||Number
1469235|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent change in BOLD signal||Full Range|Median
1469236|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent change in Bold signal||Full Range|Median
1469237|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects with at least one efficacy evaluation after baseline|||Percent change in BOLD signal||Full Range|Median
1469238|NCT00711516|Secondary|Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)|Functional magnetic resonance imaging (fMRI) is a brain imaging technique that identifies neuronal activation in regions related to specific tasks or sensory stimulation such as language, vision, hearing, and short-term memory. When neuronal activity increases, blood flow increases to that part of the brain with an increase in the oxygen content of the blood. Increase in oxygen content causes the fMRI signal in that part of the brain to change, and is the basis of the BOLD effect. The percent change in BOLD signal from Baseline to 2 weeks or last observation after baseline is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Percentage change in BOLD signal||Full Range|Median
1469239|NCT00711516|Secondary|Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint|The MOS-CF6 is an instrument to assess patient self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem solving, and processing speed. The CF 6 item responses include 6 choices, ranging from “none of the time” to “all of the time.” The CF-6 was scored by summing responses across the 6 items and converting the total to a 0 to 100 point scale, with higher scores indicating better cognitive functioning. Change in MOS-CF6 from baseline to endpoint is reported.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Population defined as subjects who had at least one efficacy evaluation after baseline.|||Units on a scale||Standard Error|Least Squares Mean
1469259|NCT00711490|Secondary|Change in Visual Acuity From Baseline to 12 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|12 months||||ETDRS letters||Full Range|Median
1469413|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1469240|NCT00711516|Secondary|Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint|Severity of sleepiness, was assessed by the Clinical Global Impression of Severity (CGI-S) at Baseline. The clinician assessed the change from baseline in the patient’s condition, as related to excessive sleepiness, in response to treatment using the CGI-C, which consisted of the following 7 categories and scoring assignments: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. Responders had to be at least minimally improved from Baseline to qualify as a responder at Endpoint.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Participants|||Number
1469241|NCT00711516|Secondary|Epworth Sleepiness Scale Change From Baseline to Endpoint|The patient’s evaluation of excessive daytime sleepiness was measured by the patient reported measure, ESS (Johns1991). The ESS score was based on responses to questions referring to 8 everyday situations (eg, sitting and reading, talking to someone, being stopped in traffic) and reflected a patient’s propensity to fall asleep in those situations. The ESS score was derived from the sum of the values from questions corresponding to the 8 situations. Scores for the ESS ranged from 0 to 24, with a higher score indicating a greater daytime sleepiness. Change from baseline to endpoint is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full analysis set defined as subjects who had at least one efficacy evaluation after baseline|||Units on a scale||Standard Error|Least Squares Mean
1469242|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient had to work out how many moves the solutions required in their heads. Mean change from baseline to endpoint in number of choices to correct for hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Choices to correct||Standard Deviation|Mean
1469243|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on the Tower of London and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Patient shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient is shown one demonstration problem and then solves 3 additional problems (easy). Problems increased in complexity, from one to six moves. With additional problems (hard) the patient has to work out how many moves the solutions required in their heads. Mean change from Baseline to endpoint in number of choices to correct for easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy measure after baseline|||Choices to correct||Standard Deviation|Mean
1469244|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the hard problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Standard Deviation|Mean
1469245|NCT00711516|Secondary|One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint|OTS is a spatial planning test based on Tower of London test and the CANTAB Stockings of Cambridge test, and measures frontal lobe function. Subject is shown 2 displays containing 3 colored balls and a row of boxes containing numbers. The patient was shown one demonstration problem and then had to solve 3 additional problems (easy). The problems increased in complexity, from one to six moves. With additional problems subject had to work out how many moves the solutions required in their heads (hard). Change from baseline to endpoint in Mean correct latency for the easy problems is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Milliseconds (ms)||Standard Deviation|Mean
1469246|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in a single location during the simple reaction time phase. The change from baseline to endpoint in median correct latency is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Full Range|Median
1469247|NCT00711516|Secondary|Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint|The RTI is a measure of simple and choice reaction time, movement time and spatio-temporal vigilance during simple and 5 choice reaction time trials. This task also permits measurement of anticipatory/premature responding and perseverative responding. The patient responded to a yellow spot appearing on the screen by letting go of the press pad and touching the location in which the spot appeared. The yellow spot appeared in any 1 of 5 locations in the 5 choice reaction time phase. The change from baseline to endpoint in median correct latency is presented.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Milliseconds (ms)||Full Range|Median
1469313|NCT00711087|Primary|A Change in DLPP of 20cm H2O at Day 30 and Day 120 in the BTX-A Injected Group (Group 1) Compared to the Sham Saline Injected Group (Group 2).|This outcome measure was not able to be determined due to the subject being lost to follow-up. The subject no longer returns phone calls or visits the clinic.|2.5 years|Early spinal cord injury||||||
1469248|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint|"The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory as measured by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Twenty minutes following the immediate recognition test, another delayed recognition test is performed, featuring the same stimuli as in the first phase. The change from baseline to endpoint in percent correct responses of this delayed test are presented here. Subjects complete 24 trials per assessment."|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent correct trials|Participants|Standard Deviation|Mean
1469249|NCT00711516|Secondary|Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint|The PRM test from the Cambridge Neuropsychological Test Automated Battery (CANTAB) assesses episodic memory by a patient’s ability to encode and recognize visual information. Patterns appear sequentially on the screen, and patients are instructed to remember them. Immediately afterwards a recognition test is performed, in which each pattern shown earlier is presented with another pattern of similar form and color. Patient has to touch the pattern seen earlier. Change from baseline to endpoint in % correct responses with immediate recall is presented. Subjects complete 24 trials per assessment.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy evaluation after baseline|||Percent correct trials|Participants|Standard Deviation|Mean
1469250|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus|The outcome was the change from baseline in number of contiguous activated voxels in the thalamus on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value significantly (p<0.05), the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set|||Activated voxels||Standard Error|Mean
1469251|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)|The outcome was the change from baseline in number of contiguous activated voxels in the posterior parietal cortex (PPC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value with p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Activated voxels||Standard Deviation|Mean
1469252|NCT00711516|Secondary|Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)|The outcome was the change from baseline in number of contiguous activated voxels in the anterior cingulate cortex (ACC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline|||Activated Voxels||Standard Deviation|Mean
1469253|NCT00711516|Secondary|Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed|The 2-Back is a verbal working memory test in which random letters are presented visually every 4 sec, with each stimulus lasting 500 msec. Subjects are asked to make a yes/no response following each letter indicating whether it was the same or different from the letter presented two earlier. The load on working memory was the ordering, retention, updating, and manipulation of 2 letters and consideration of the relationship to a 3rd newly presented letter, which could have been a target or a nontarget. The change from baseline in response latency at endpoint is presented here.|Baseline and Endpoint (Week 2 or last observation after baseline)|Full Analysis Set defined as subjects who had at least one efficacy assessment after baseline.|||Milliseconds (ms)||Standard Deviation|Mean
1469254|NCT00711516|Primary|Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation|The primary outcome was the change from baseline in number of contiguous activated voxels in the dorsolateral prefrontal cortex (DLPFC) on functional magnetic resonance imaging (fMRI) at Week 2(or last observation after baseline). Each voxel is compared to the reference wave form. If it differs from that value p<0.05, the voxel is considered active. fMRI is a brain imaging technique that identifies neuronal activation related to specific tasks or sensory stimulation. Increased neuronal activity increases blood flow and oxygen content to the activated part of the brain, altering fMRI signal.|Baseline and Endpoint (Week 2 or last observation after baseline)|Efficacy analyses were performed on the full analysis dataset which includes those patients in the safety analysis set who had at least 1 post baseline primary efficacy assessment.|||Activated voxels||Standard Deviation|Mean
1469255|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 12 Months, as Measured on Fluorescein Angiography (FA)||12 months|||||||
1469256|NCT00711490|Secondary|Change in Fluid Leakage in the Macula of the Study Eye From Baseline to 6 Months, as Measured on Fluorescein Angiography (FA)||6 months|||||||
1469257|NCT00711490|Secondary|Change in Retinal Thickness From Baseline to 12 Months, as Measured by Optical Coherence Tomography (OCT)|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|12 months||||μm||Full Range|Median
1469260|NCT00711490|Primary|Change in Visual Acuity From Baseline to 6 Months|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. This acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters the Snellen measurement is 20/20.|6 months||||ETDRS letters||Full Range|Median
1469261|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Posterior Insula|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1469262|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Parietal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1469263|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 2|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1469264|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 1|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1469265|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Anterior Cingulate|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1469266|NCT00711477|Secondary|Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire|Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1469267|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in External Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The External Eating subscale consisted of 10 items and the scores ranged from 10 (better outcome) to 50 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1469268|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating B Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating B subscale (diffuse emotions) consisted of 4 items and the scores ranged from 4 (better outcome) to 20 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1469269|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Emotional Eating A Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Emotional Eating A subscale (clearly labeled emotions) consisted of 9 items and the scores ranged from 9 (better outcome) to 45 (worse outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1469270|NCT00711477|Secondary|Dutch Eating Behavior Questionnaire - Change in Restrained Eating Subscale Score|The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating). Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often. The Restrained Eating subscale consisted of 10 items and the scores ranged from 10 (worse outcome) to 50 (better outcome).|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||units on a scale||Standard Error|Least Squares Mean
1469271|NCT00711477|Secondary|Percent Change in Body Weight||Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percentage of body weight||Standard Error|Least Squares Mean
1469350|NCT00711009|Secondary|Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1469272|NCT00711477|Primary|Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal|Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.|Baseline, 4 weeks|ITT (Intent-to-Treat): Included all subjects who were randomized, had a baseline measurement, and had at least one post-baseline fMRI measurement during the defined treatment phase.|||percent activation||90% Confidence Interval|Mean
1469273|NCT00711464|Secondary|Heart Rate|beats per minute|3-5 hours||||beats per minute||Standard Deviation|Mean
1469274|NCT00711464|Secondary|Systolic Blood Pressure|systolic blood pressure in mm Hg|3-5 hours||||mm Hg||Standard Deviation|Mean
1469275|NCT00711464|Primary|Cognitive Performance|Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control|3-5 hours||||percentage correct of all trials||Standard Deviation|Mean
1469276|NCT00711425|Primary|Marginal Bone Adaptation|Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients). At 5-year follow-up, 41 patients were still in the study and thus evaluable for the analysis.|||Millimeter|Participants|Standard Deviation|Mean
1469277|NCT00711425|Primary|Implant Stability|Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).At 1-year follow-up, 43 patients were still in the study and thus evaluable for the analysis.|||ISQ|Participants|Standard Deviation|Mean
1469278|NCT00711425|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).|||Percentage of implants|Participants||Number
1469279|NCT00711412|Post-Hoc|Overall Survival||From the start of treatment and then every 3 months until death or a maximum of 24 months.|1 patient was registered to the study, but was not treated on study and was therefore not evaluable. Data for overall surivival was collected at 3 months, 6 months, 12 months and 24 months. There was no further data analysis completed|||percentage of patients alive|||Number
1469280|NCT00711412|Post-Hoc|Determine Progressive Free Survival||After cycles 2, and 4 (pre-surgery) 30 days after surgery and then every 3 months until first documentation of progressive disease, death and up to a maximum of 24 months.|The only data collected for this outcome measure was progression free survival rate at 3 months, 6 months, and 12 months.|||percentage of patents progression free|||Number
1469281|NCT00711412|Secondary|Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy.||At time of sugery|No data was collected for this outcome measure. There is no data to report on.||||||
1469282|NCT00711412|Secondary|Toxicity Profile|"Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0)~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE~Only incidents of AEs determined to be related to chemotherapy are recorded here."|During chemotherapy treatment and up to 30 days post-last dose of chemotherapy.|Toxicity data was collected and analysed for the first 40 patients.|||participants|||Number
1469283|NCT00711412|Secondary|Patterns of Failure||At time of surgery|No data collected for this outcome measure. There is no data to report on.||||||
1469284|NCT00711412|Secondary|Time to Progression|Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact.|From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months.|Data collected was not analyzed before the study was terminated. Count of participants indicates the number of patients with progressive disease or death at the time the study closed permanently.|||Participants|||Count of Participants
1469285|NCT00711412|Secondary|Recurrence Rate|Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study.|From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months.|1 patient was registered but not treated on study and therefore was not evaluable.|||Participants|||Count of Participants
1469286|NCT00711412|Secondary|Clinical Response Rate|"Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) .~Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD"|four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery|1 patient was registered to the study but was not treated on study and was therefore not evaluable.|||Participants|||Count of Participants
1469287|NCT00711412|Primary|Determine Pathologic Complete Response|"Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections.~Pathologic response will be defined as:~P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer"|At time of surgery|Patients analyzed were patients that reached and completed surgery.|||Participants|||Count of Participants
1469288|NCT00711347|Secondary|Surgeon Survey|"Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported:~Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult~Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree~Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective"|Time of Surgery||||Units on a scale||Standard Deviation|Mean
1469289|NCT00711347|Secondary|Aqueous Signs - Edema|"Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale:~0 = none~= mild - slight localized or generalized edema~= moderate - significant localized or generalized edema~= severe - advanced localized or generalized edema"|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
1469290|NCT00711347|Secondary|Aqueous Signs - Flare|"Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale:~0:No-Visible flare when compared with the normal eye.~Mild-Flare visible against dark papillary background but not visible against iris background.~Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.~Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp."|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
1469291|NCT00711347|Secondary|Aqueous Signs - Cells|Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells|1 Day Postoperative|14 patients/28 eyes in each group.|||Units on a scale||Standard Deviation|Mean
1469292|NCT00711347|Secondary|Intraocular Pressure (IOP)|Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.|1 Day Postoperative|14 patients/28 eyes in each group.|||mmHg||Standard Deviation|Mean
1469293|NCT00711347|Primary|Corneal Endothelial Cell Loss|Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.|1 month|14 patients/28 eyes in each group.|||Percent change||Standard Deviation|Mean
1469294|NCT00711191|Other Pre-specified|Recommended Phase 2 Dose (RP2D) of CP-870893 in Participants With Advanced Pancreas Cancer|Additional participants enrolled at MTD of CP-870893 to further characterize suitability for phase 2 testing. RP2D confirmed if ≤ 3 our of 12 participants in expansion cohort experience DLT in cycle 1.|Baseline up to time of determination of maximum tolerated dose (MTD)|Safety population|||mg/kg|||Number
1469295|NCT00711191|Secondary|Carbohydrate Antigen 19-9 (CA 19-9)|CA 19-9 or sialylated Lewis (a) antigen (a tumor marker). Values higher than 37 units per milliliter (U/ml) considered abnormal; higher values usually indicate greater presence of disease.|At the end of every even-numbered cycle (cycle=28 days) and 4 to 6 weeks following initial documentation of response|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469296|NCT00711191|Secondary|18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort)|FDG PET assessment to characterize and monitor tumors before and after study treatment; measured as a standardized uptake value (SUV). A reduction in SUV from baseline for at least 1 tumor may indicate a positive metabolic response to treatment.|Baseline, Week 2, Week 8, and Single Time Point (STP) PET for all PET scans after Week 8|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469297|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR)|Assess the ability of PF-870893 to activate B-cells and HLA-DR which are involved in the production of antibodies. Change calculated as mean of pre-dose and post-dose values. Positive values indicate greater presence of cells associated with antibody production.|Cycle 1 / Day 1 and Cycle 1 / Day 8 prior to gemcitabine infusion and 6 and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-870893 infusion and 6, 24, and 48 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469298|NCT00711191|Secondary|Total and Neutralizing Human Antihuman Antibody (HAHA) Titer|HAHA assessed as an indicator of immunogenicity to CP-870893.|Prior to infusion of CP-870893 on Day 3 of every cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469299|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469300|NCT00711191|Secondary|Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX)|An increase in values indicates greater cytokine release from cells targeted by the antibody and may be associated with an infusion reaction. Change calculated as mean of pre-dose and maximum post-dose values.|Cycle 1 / Day 1 prior to gemcitabine infusion (0 hour), 5 minutes after EOI and 2, 4, 6, and 24 hours after EOI; Cycle 1 / Day 3 prior to CP-970893 infusion (0 hour), 5 minutes after EOI, and 2, 4, 6, and 24 hours after EOI|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1479269|NCT00631488|Secondary|Change From BL to Week 4 in Fasting Plasma Glucose (FPG)||BL, 4 weeks (end of double-blind treatment period)|Full Analysis Set Population|||mg/dL||Standard Error|Least Squares Mean
1469301|NCT00711191|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the serum concentration time-curve from time zero to the last measured concentration. AUClast analyzed using a noncompartmental approach to estimate individual participant values.|Cycle 1 / Day 3 pre-dose, 5 minutes after EOI, and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469302|NCT00711191|Secondary|Maximum Serum Concentration (Cmax)||Cycle 1 / Day 3 pre-dose, 5 minutes after End of Infusion (EOI), and 2, 6, and 24 hours after EOI and pre-dose on Day 3 of every subsequent cycle up to a maximum of 12 cycles|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469303|NCT00711191|Secondary|Time to Progression|Disease progression defined as ≥20% increase in sum LD of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Criteria for progression also included unequivocal progression of existing nontarget lesions.|Monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|No analyses of these parameters were performed due to the Sponsor's decision to terminate clinical evaluation of CP-870893.||||||
1469304|NCT00711191|Secondary|Progression Free Survival (PFS)|PFS is time from baseline to first progression (Prog) or death from any cause. Participants last known to be alive, had not started a new (non-protocol) cancer treatment, were Prog-free, and who had a baseline and ≥1 on-study disease assessment were censored at date of last objective disease assessment that verified lack of Prog. Participants who were off treatment prior to Prog and who had no on-study disease assessment were also censored. Prog: ≥20% increase in sum of longest dimension (LD) of target lesions from smallest sum LD recorded since treatment start or appearance of ≥1 new lesions.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95% CI for 50% quartile based on Brookmeyer and Crowley Method. Criteria for progression also included unequivocal progression of existing nontarget lesions.|||months||95% Confidence Interval|Median
1469305|NCT00711191|Secondary|Overall Survival (OS)|OS is time from baseline to death from any cause. Participants last known to be alive were censored at the date of last contact.|Baseline, assessed monthly until death or 7.5 months after last participant was enrolled (up to January 2011)|Safety population; Kaplan-Meier estimate of time to event 95 percent confidence interval (95% CI) for 50% quartile based on Brookmeyer and Crowley Method.|||months||95% Confidence Interval|Median
1469306|NCT00711191|Secondary|Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST)|Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|At the end of every even-numbered cycle (cycle=28 days) up to a maximum of 12 cycles and 4 to 6 weeks following initial documentation of response|Safety population; Confidence Interval (CI) calculated using exact method based on binomial distribution.|||percentage of participants||95% Confidence Interval|Number
1469307|NCT00711191|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|"Any of the following during first cycle of treatment and attributable to CP-870893:~afebrile Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) ≥7 days or Gr 3 or 4 neutropenia associated with fever (1 oral temperature >38.5 degrees Celsius (C) or 3 oral temperatures >38.0 degrees C in a 24-hour period); Gr 4 thrombocytopenia or Gr 3 thrombocytopenia associated with bleeding; Gr 4 lymphopenia, if coupled with clinical consequence (such as, opportunistic infection) or any other Gr 3 hematological adverse events; ≥Gr 3 non-hematologic toxicities (except alopecia)."|Baseline up to Cycle 1 / Day 28|Safety population: all participants who received any study treatment. Cubic millimeters (mm^3).|||participants|||Number
1469308|NCT00711113|Primary|Marginal Bone Adaptation|Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.|At baseline (loading) and at 5 year follow-up|Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.|||Millimeter|Participants|Standard Deviation|Mean
1469309|NCT00711113|Primary|Implant Stability|Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.|At 1 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.|||units on a scale|Participants|Standard Deviation|Mean
1469310|NCT00711113|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5 year follow-up|Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.|||percentage of implants|Participants||Number
1469311|NCT00711100|Primary|Abstinence From Cigarettes|Abstinence from cigarettes during Abstinence Phase.|Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)|At the end of Sampling Phase, subjects chose a preferred product to use during a two week Abstinence Phase. Abstinence from cigarettes was determined during the 2 week study product phase (e.g., Abstinence Phase) and 1 week after this phase.|||Participants|||Count of Participants
1469312|NCT00711100|Primary|Product Preference|Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).|2 weeks||||participants|||Number
1469314|NCT00711022|Primary|Implant Survival Rate|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|At 5-year follow-up|Per protocol analysis presented, this includes implants loaded within 24 hours from implant placement (306 implants in 51 subjects), of these 20 implants failed during the 5 year follow-up period.|||percentage of implants|Participants||Number
1469315|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams/cm^2||Standard Deviation|Mean
1469316|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)|The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469317|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469318|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469319|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469320|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469321|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469322|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469323|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469324|NCT00711009|Secondary|Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469325|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469326|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469327|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469328|NCT00711009|Secondary|Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)|The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||grams||Standard Deviation|Mean
1469329|NCT00711009|Secondary|Mean Change From Baseline in Mid-Thigh Measurement (cm)|Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1469330|NCT00711009|Secondary|Mean Change From Baseline in Hips Measurement (cm)|Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1469331|NCT00711009|Secondary|Mean Change From Baseline in Mid-Arm Measurement (cm)|Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant’s arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1469332|NCT00711009|Secondary|Mean Change From Baseline in Waist Measurement (cm)|Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant’s waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 are included in the analysis.|||cm||Standard Deviation|Mean
1469333|NCT00711009|Secondary|Mean Change From Baseline in Chest Measurement (cm)|Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant’s chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||cm||Standard Deviation|Mean
1469334|NCT00711009|Secondary|Mean Change From Baseline in Temperature (°F)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||°F||Standard Deviation|Mean
1469335|NCT00711009|Secondary|Mean Change From Baseline in Weight (kg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||kg||Standard Deviation|Mean
1469336|NCT00711009|Secondary|Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||beats per minute||Standard Deviation|Mean
1469337|NCT00711009|Secondary|Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||mm Hg||Standard Deviation|Mean
1469338|NCT00711009|Secondary|Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||mm Hg||Standard Deviation|Mean
1469339|NCT00711009|Secondary|Mean Change From Baseline in Urine pH||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||pH||Standard Deviation|Mean
1469340|NCT00711009|Secondary|Mean Change From Baseline in Urine Specific Gravity|Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||ratio of urine density to water density||Standard Deviation|Mean
1469341|NCT00711009|Secondary|Mean Change From Baseline in Insulin (Picomoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picomoles/liter||Standard Deviation|Mean
1469342|NCT00711009|Secondary|Mean Change From Baseline in Leptin (Nanograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||nanograms/milliliter||Standard Deviation|Mean
1469343|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picograms/milliliter||Standard Deviation|Mean
1469344|NCT00711009|Secondary|Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||picograms/milliliter||Standard Deviation|Mean
1469345|NCT00711009|Secondary|Mean Change From Baseline in Lactate (Millimoles/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
1469346|NCT00711009|Secondary|Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||nanograms/liter||Standard Deviation|Mean
1469347|NCT00711009|Secondary|Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micrograms/milliliter||Standard Deviation|Mean
1469348|NCT00711009|Secondary|Mean Change From Baseline in Magnesium (Millimoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||millimoles/liter||Standard Deviation|Mean
1469349|NCT00711009|Secondary|Mean Change From Baseline in Lipase (Units/Liter)|Included in measures of metabolic toxicity|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1469362|NCT00711009|Secondary|Mean Change From Baseline in Potassium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469363|NCT00711009|Secondary|Mean Change From Baseline in Sodium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469364|NCT00711009|Secondary|Mean Change From Baseline in Calcium (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469365|NCT00711009|Secondary|Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469366|NCT00711009|Secondary|Mean Change From Baseline in Uric Acid (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469367|NCT00711009|Secondary|Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469368|NCT00711009|Secondary|Mean Change From Baseline in Creatinine (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469369|NCT00711009|Secondary|Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||micromoles/liter||Standard Deviation|Mean
1469370|NCT00711009|Secondary|Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1469371|NCT00711009|Secondary|Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1469372|NCT00711009|Secondary|Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1469373|NCT00711009|Secondary|Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||units/liter||Standard Deviation|Mean
1469374|NCT00711009|Secondary|Mean Change From Baseline in Basophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1469375|NCT00711009|Secondary|Mean Change From Baseline in Eosinophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1469376|NCT00711009|Secondary|Mean Change From Baseline in Monocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1469377|NCT00711009|Secondary|Mean Change From Baseline in Lymphocytes (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1469378|NCT00711009|Secondary|Mean Change From Baseline in Neutrophils (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1469379|NCT00711009|Secondary|Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1469380|NCT00711009|Secondary|Mean Change From Baseline in Platelet Count (x 10^9/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^9/liter||Standard Deviation|Mean
1469381|NCT00711009|Secondary|Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||number of cells x 10^12/liter||Standard Deviation|Mean
1469382|NCT00711009|Secondary|Mean Change From Baseline in Hematocrit (Fraction)|Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||% by volume of packed RBCs in blood||Standard Deviation|Mean
1469383|NCT00711009|Secondary|Mean Change From Baseline in Hemoglobin (Grams/Liter)||Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||grams/liter||Standard Deviation|Mean
1469384|NCT00711009|Secondary|Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication|The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1469385|NCT00711009|Secondary|Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication|The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1469414|NCT00710840|Secondary|Functional Performance: Stair Climb Test|This outcome measures the time (seconds) it takes to climb up and back down 12 steps.|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Seconds||Standard Deviation|Mean
1469386|NCT00711009|Secondary|Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)|The Effectiveness Scale of the TSQM evaluates the participant’s satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.|Week 96|Participants who had values at Week 96 were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
1469387|NCT00711009|Secondary|Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||Scores on a scale||Standard Error|Mean
1469388|NCT00711009|Secondary|Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey|The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.|Baseline to Week 96|Participants who had values at Baseline and Week 96 were included in the analysis.|||Scores on a scale||Standard Error|Mean
1469389|NCT00711009|Secondary|Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir|Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/mL to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.|||Participants|||Number
1469390|NCT00711009|Secondary|Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.|Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.|Baseline to Week 96|The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from <40 copies/ml to >=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.|||Participants|||Number
1469391|NCT00711009|Secondary|Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672|Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.|Baseline to Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1469392|NCT00711009|Secondary|Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit||Baseline to Week 96|Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.|||cells/microliter||Standard Error|Mean
1469393|NCT00711009|Primary|Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values|Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.|Baseline to Week 96|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.|||Percentage of participants|||Number
1469394|NCT00711009|Secondary|Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 96|Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1469415|NCT00710840|Primary|Knee Range of Motion|Knee Flexion Active Range of Motion (AROM)|Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||degrees||Standard Deviation|Mean
1469416|NCT00710840|Secondary|Functional Performance: 6 Minute Walk (6MW) Distance||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Meters||Standard Deviation|Mean
1469395|NCT00711009|Primary|Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events|Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.|Week 96|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
1469396|NCT00711009|Primary|Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm|A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.|Baseline to Week 48|Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
1469397|NCT00710996|Primary|Photostress Recovery Time in Seconds.|The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.|3 months||||seconds||Standard Deviation|Mean
1469398|NCT00710970|Primary|Sustained Stable Disease is Considered to be Clinically Important. Hence, 4-month Freedom From Progression (FFP) (Stable Disease + Partial Response + Complete Response) is Chosen as the Primary End-point Instead of Response Rate.||4 months||||participants|||Number
1469399|NCT00710970|Primary|Tamoxifen : Tamoxifen is Administered at 20 mg/Day as a Single Daily Oral Dose. Tamoxifen is Continued Until Progressive Disease or Intolerable Grade 3 or 4 Side Effects Occur Due to Tamoxifen.||To progression|||||||
1469400|NCT00710944|Primary|Implant Survival|An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.|12 months after implant placement|Per protocol analysis presented, this includes implants immediately loaded (Group A: 55 implants in 55 subjects, Group B: 58 implants in 58 subjects, Group C: 19 implants in 19 subjects), of these 5 implants in total failed within 12 months after implant placement.|||percentage of implants|Participants||Number
1469401|NCT00710931|Primary|Binocular Visual Acuity at Distance, Near and Intermediate|Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery||||LogMAR||Standard Deviation|Mean
1469402|NCT00710905|Primary|Binocular Visual Acuity at Near, Intermediate and Distance|Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better VA.|6 months after surgery||||LogMAR||Standard Deviation|Mean
1469403|NCT00710879|Secondary|Solution Utlility|The Utility was determined based on the results of the efficacy and safety evaluations.|3 months, 6 months|All Eligible, Dispensed Eyes|||Eyes|Participants||Number
1469404|NCT00710879|Secondary|Solution Related AE's and Lens Changes|Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.|3 months, 6 months|All Eligible, Dispensed Eyes|||Eyes|Participants||Number
1469405|NCT00710879|Primary|Antimicrobial Efficacy|Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae|2 weeks, 3 months|All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.|||Eyes|Participants||Number
1469406|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Toddlers(12-23 Months)-|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol|||participants|||Number
1469407|NCT00710866|Primary|Adverse Events: Fever After Either Dose - Infants 6-11 Months|Fever defined as temperature >= 38 C|3 days after immunization|Per Protocol|||participants|||Number
1469408|NCT00710866|Primary|Seroprotection Rate Toddlers (12-23 Months)-B/Florida/4/06(Yamagata)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1469409|NCT00710866|Primary|Seroprotection Rate Infants (6-11 Months)-B/Florida/4/06(Yamagata)||27-46 days after the second dose|Per Protocol|||participants|||Number
1469410|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1469411|NCT00710866|Primary|Seroprotection Rate Infants(6-11 Months)-A/Brisbane/10/07(H3N2)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1469412|NCT00710866|Primary|Seroprotection Rate Toddlers(12-23 Months)-A/Brisbane/59/07(H1N1)|Seroprotection rate: HI titers =>40|27-46 days after the second dose|Per Protocol|||participants|||Number
1469417|NCT00710840|Primary|Quadriceps Muscle Force||Measured pre-operatively; post-surgery at 4 weeks and 12 weeks||||Nm/kg||Standard Deviation|Mean
1469418|NCT00710814|Primary|Weight Change (in kg.) After Each Intervention|"For the Leptin Intervention, 16 week values were compared to baseline for those who received Leptin in the first period, and 32 week values were compared to 16 week values in those who received Leptin in the second period.~For the Placebo Intervention, 16 week values were compared to baseline for those who received Placebo in the first period, and 32 week values were compared to 16 week values in those who received Placebo in the second period."|0 weeks, 16 weeks and 32 weeks||||kg weight change||95% Confidence Interval|Mean
1469419|NCT00710762|Secondary|Clinical Relevant Abnormalities for Laboratory Parameters|Clinical Relevant Abnormalities for laboratory parameters. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.|First drug administration until 28 days after last drug administration, up until 309 days|Treated set|||Percentage of participants|||Number
1469420|NCT00710762|Secondary|Incidence and Intensity of Adverse Events With Grading According CTCAE|Incidence and intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|First drug administration until 28 days after last drug administration,up until 309 days|Treated set|||percentage of participants|||Number
1469421|NCT00710762|Secondary|Time to Death|This end point was not determined as no patients died during the trial.|9 months|This endpoint could not be calculated as no patients died.||||||
1469422|NCT00710762|Secondary|Time to Tumour Progression|"Time to Tumour Progression according to RECIST version 1.0 , CA-125 (ovarian tumour marker) levels and RECIST + CA-125 levels.~For CA-125, progressive disease was defined on the basis of progressive serial elevations of CA-125 according to the following criteria:~Patients with elevated CA-125 pre-treatment and normalisation of CA-125 had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart. or Patients with elevated CA-125 pre-treatment that never normalised had to show evidence of CA-125 levels ≥2 x the nadir value on 2 occasions at least 1 week apart. or Patients with CA-125 in the normal range pre-treatment had to show evidence of CA-125 levels ≥2 x ULN on 2 occasions at least 1 week apart.~Composite (RECIST+CA-125) endpoint is the RECIST progressive disease (PD) if it occurred or the CA-125 PD if it occurred in the absence of RECIST PD."|9 months|Treated set|||days||95% Confidence Interval|Median
1469423|NCT00710762|Secondary|PFS Rate at 12 Weeks (After 3 Months) and 24 Weeks ( After 6 Months)|The rate (probability) of being progression free at Week 12 and Week 24. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|12 weeks (after 3 months) and 24 weeks ( after 6 months)|Treated set|||percent probability of PFS||95% Confidence Interval|Number
1469424|NCT00710762|Primary|PFS Rate at 36 Weeks (After 9 Months)|The rate (probability) of being progression free at Week 36. Progression Free Survival (PFS) was defined according to RECIST version 1.0 from the time of first study drug administration to the first time of either objective tumour progression, the appearance of ≥1 new tumour lesion(s), occurrence or significant progression of malignant ascites, tumour related death, or the time when patients were censored at last known follow up. The rate is the Kaplan-Meier estimated percent probability.|36 weeks (after 9 months)|Treated set.|||percent probability of PFS||95% Confidence Interval|Number
1469425|NCT00710749|Primary|Mean Urine Flow Rate|Measurements with a disposable device and the current clinic gold standard measurement were compared to test the hypothesis that three repeated measurements with the disposable device was as accurate as one clinic flow measurement. A digital device was used as a reference of the most exact way to evaluate each patient's individual flow.|At every voiding event during approximately one week.|Intention to treat analysis. Number of participants analyzed differs between groups since data was missing mainly due to technical problems.|||ml/s||Standard Deviation|Mean
1469426|NCT00710684|Secondary|Change From Baseline in RBANS Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
1469427|NCT00710684|Secondary|Change From Baseline in CDR-SB Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. The CDR-SB is an interviewer administered scale and impairment is scored in following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment was scored on a scale in which none =0, questionable =0.5, mild =1, moderate =2 and severe =3. The 6 individual category ratings, or “box scores”, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher score indicating severe impairment. If there were any missing items then CDR-SB was set to missing and was not imputed. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
1469443|NCT00710606|Secondary|Mean Endometrial Proliferation|The mean endometrial proliferation from week 1, week 2 and week3|Transvaginal ultrasound measurements of endometrial proliferation will be completed over continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||millimeters||Standard Deviation|Mean
1469648|NCT00709228|Primary|Number of HCV LVL G1 Participants Who Relapsed|Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.|Week 24 of follow-up|The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.|||Participants|||Number
1469428|NCT00710684|Secondary|Change From Baseline in ADAS-Cog Scale in Participants With APOE4 Gene|Genetic analyses was conducted to assess the effect of APOE4 carriage. ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five-point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores were recorded on the CRF for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. Baseline was Week 0 value. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value.|Baseline (Week 0) to Week 24 and Week 48|PGx ITT Population consisted of all participants in the ITT population who had evaluable PGx data. Only those participants with APOE gene and available at the specified time point were analyzed.|||Score on scale||Standard Deviation|Mean
1469429|NCT00710684|Secondary|Exposure Estimates for Donepezil (Cavgss)|Participants who were on donepezil (at least 6 months and a stable regimen for at least 2 months) were allowed to participate in this study. Cavgss for donepezil approximately 12 to 20 hours after dosing were summarized by donepezil dose level 5 mg/7.5 mg/10 mg/15 mg.|Post-dose at 12 to 20 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|Donepezil PK population comprised of participants who received a stable dose of donepezil 5 mg/7.5 mg/10 mg/15 mg. Analysis is exclusively for Cavgss of donepezil therefore the two arms SB-742457 15 mg and SB-742457 35 mg have not been presented.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1469430|NCT00710684|Secondary|Exposure Estimates for SB-742457 : Minimum Concentrations at Steady State (Cmin-ss)|Cmin-ss was estimated via nonlinear mixed effect analysis. This PK model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.|Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1469431|NCT00710684|Secondary|Exposure Estimates for SB-742457 : Area Under the Concentration Time Curve Over the Dosing Interval at Steady State (AUCτss)|AUCτss of SB-742457 was estimated via nonlinear mixed effect analysis. This pharmacokinetic(PK) model was a steady state one compartment model with first-order absorption, with between participant variability on clearance and volume of distribution.|Post-dose at 3, 8 and 24 hours on Week 0, 1, 3, 6, 12, 18, 24, 30, 36, 42 and 48|PK population included all participants for whom a pharmacokinetic sample was obtained and analyzed.|||Nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
1469432|NCT00710684|Secondary|Number of Participants With Parameters of Clinical Concern - Clinical Chemistry|Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Alanine Amino Transferase (ALT) (high-1.5), Alkaline Phosphatase (high-1.5), Aspartate Amino Transferase (ASAT) (high-1.5), BUN/Creatinine ratio (high-1.5), Calcium (low- 0.75, high-1.25), Carbon dioxide content/Bicarbonate (low-15, high- 40), Cholesterol (high-1.25), Creatine Kinase ((low- 0.5, high-1.25), Creatinine (low- 0.5, high-1.25), Direct Bilirubin (high-1.5), Gamma Glutamyl Transferase (GGT) (high-2), Glucose (low- 3.6, high-7.8), HDL Cholesterol (low-0.65), LDL Cholesterol (hig-1.25), Magnesium (low-0.5, high-2), Phosphorus inorganic (low- 0.5, high-1.5), Potassium (low- 3, high-5.5), Sodium (low- 130, high-150), Total Bilirubin (high-1.5), Triglycerides (high -4) and Urea/BUN (high-11).|Up to Week 48|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1469433|NCT00710684|Secondary|Number of Participants With Parameters of Clinical Concern - Hematology|Only parameters with values have been presented. Data has been reported for number of participants with high and/ or low values for Eosinophils (high-2), Hematocrit (low- 0.8, high-1.2), Lymphocytes (low-0.75, high-1.5), Mean Corpuscle Hemoglobin (MCH) (low-0.8, high-1.2), Monocytes(low-0.75, high-2), Neutrophil bands (high-10), Platelet count (low-100, high-500), Segmented Neutrophils (low-0.75, high-1.3), Total Neutrophils (low-0.75, high-1.5), and white blood cells (WBC) (low-3, high-15).|Up to Week 48|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
1469434|NCT00710684|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During Treatment Phase|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to follow-up i.e. 2 weeks post end of treatment (Week 24, Week 48 or Early Withdrawal)|Safety population consisted of all participants randomized to treatment who had received at least one dose of study medication.|||Participants|||Count of Participants
1469435|NCT00710684|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Week 24 and 48|The MMSE consisted of 11 items covering orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Scores for each of the 11 individual tests were not recorded on the CRF, therefore if any item was missing then the total score was be set to missing. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 24 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469444|NCT00710606|Secondary|Number of Participants Achieving a Maximum Follicle Diameter > 13mm During the 3 Weeks of Follow-up|Follicular development was minimal in both groups, with only five women achieving a maximum follicle diameter > 13mm at any time during the 3 weeks of follow-up (3 normal weight and 2 obese women).|continuous ring use, an average of 3 weeks|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||Participant w/follicular diameter >=13mm|||Number
1469436|NCT00710684|Secondary|Change From Baseline in Alzheimer’s Disease Co-operative Study Group – Activities of Daily Living Inventory (ADCS- ADL) Total Score at Weeks 12, 24, 36 and 48|The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions about the participant. The questions ranged from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signified greater functional ability. The questionnaire was split into two types of questions, an initial question relating to whether a participant had completed a particular activity and then a follow on question which scored how much assistance the participant had required if they had performed that particular activity. The total score was calculated by adding up the responses for each of the individual activities. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 24, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469437|NCT00710684|Secondary|Change From Baseline in RBANS Score at Week 12, 36 and 48|RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469438|NCT00710684|Secondary|Change From Baseline in CDR-SB Score at Week 12, 36 and 48|The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or “box scores”, were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 12, 36, 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469439|NCT00710684|Secondary|Change From Baseline in ADAS-Cog Total Score at Week 12, 36 and 48|ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the CRF for questions 3 to 6 and 8 to 11. In cases where more than one question was missing, a total score was not be imputed. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been present|Baseline (Week 0) and Week 12, 36 and 48|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469440|NCT00710684|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24|RBANS is an individually administered cognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). Total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where a low score indicates greater impairment. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469441|NCT00710684|Primary|Change From Baseline in Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score at Week 24|The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or “box scores”, were added together to give the CDR-Sum of Boxes which ranges from 0-18 (severe impairment). If there were any missing items then CDR-SB was set to missing and was not imputed. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean has been presented.|Baseline(Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469442|NCT00710684|Primary|Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 24|ADAS-cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. There were in all 11 questions. Total scores were calculated as the sum of the individual components. Scores ranged from 0 to 70 with higher scores indicated greater dysfunction. The ADAS-Cog total score was the sum of the calculated scores for questions 1, 2, and 7, and the scores recorded on the case report form (CRF) for questions 3 to 6 and 8 to 11. When a score was missing for one of the questions, the total score was calculated as a weighted average of the scores provided for the remaining ten questions. The change from Baseline was obtained by subtracting the Baseline value from the post-randomization value. Baseline was Week 0 value. Data for adjusted mean is presented.|Baseline(Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1482066|NCT00609739|Secondary|Patients With Graft-Versus-Host-Disease|Number of patients who exhibited acute and/or chronic graft-versus-host disease.|Up to 30 Days Post Study Treatment||||participants|||Number
1469445|NCT00710606|Primary|Mean Serum Concentrations of Etonogestrel and Ethinyl Estradiol|Serum concentrations were obtained from thirty-seven women completed follow-up.|Measurements at Week 3 and Week 6 continuous ring use|17 participants in each group was planned a priori to have 80% power to identify a one standard deviation difference in the mean serum levels of the contraceptive hormones. We enrolled 40 women, 2 withdrew prior to the study cycle. We excluded one woman due to removal of the CVR during the study cycle leaving 18 normal weight and 19 obese women.|||ng/L||95% Confidence Interval|Geometric Mean
1469446|NCT00710593|Secondary|Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).|Rate of AEs is the total number of AEs divided by the total number of participants. The rate is not a percentage bur rather it could be above 1 or less than 1. This outcome measure looked at number of AEs reported, by grade; number of AEs > Grade 3 identified; and number of AEs > Grade 3 evaluated within 24 or 48 hours.|Day 1 through Week 24||||AEs/Total Number of Participants|||Number
1469447|NCT00710593|Secondary|Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.|Visit compliance is the total number of days participants actually called the TRS or completed the VRC divided by the total number of days expected to call the TRS or complete the VRC, multiplied by 100%.|Day 1 through Week 24||||percentage of days||Standard Deviation|Mean
1469448|NCT00710593|Secondary|"Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the 12-item Knowledge About HPV and HPV Vaccine Measure)"|"To characterize young women's risk perceptions, sexual behaviors, and sexually transmitted infections (STI) diagnoses over the 48 weeks after initial vaccination, the relationship of baseline 12-item Knowledge About HPV and HPV Vaccine measure was used to evaluate the need for safer sexual behaviors."|Week 48|Total population analyzed was 99 participants. Percentage of participants reflects percentage of participants in both lower NSSB and higher NSSB.|||percentage of participants|||Number
1469449|NCT00710593|Secondary|Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination|"Participants’ perceptions for the need to practice safe sex following HPV vaccination was measured using a safer sexual behaviors subscale, which was comprised of the following five questions:~After getting vaccinated against HPV …~You feel that condom use during sex is less necessary.~You feel it is still just as important to have as few sexual partners as possible.~You feel that it is less important to talk to your sex partners about safe sex.~You think it is still just as important to use a condom every time you have sex.~You will be less worried about having unprotected sex. Those who were categorized in the “lower need for safer sexual behaviors (NSSB)” group had a summary score that was less than the median and those in the “higher NSSB” group had a summary score that was equal to or higher than the median."|Week 48||||percentage of participants|||Number
1469450|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1469451|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1469452|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1469453|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.|Week 48||||percentage of participants|||Number
1469454|NCT00710593|Secondary|Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-18 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1469455|NCT00710593|Secondary|Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-16 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative for at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1469456|NCT00710593|Secondary|Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-11 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1469457|NCT00710593|Secondary|Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).|Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-6 sero-negative by study group and study visit at Week 24.|Week 24|Subjects who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at Week 24. (The number of participants analyzed for this outcome differs from the number of participants in the Participant Flow Module.)|||percentage of participants|||Number
1469458|NCT00710593|Primary|HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-18 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
1469707|NCT00708942|Primary|Complete Response Rate|"Based on histology, cytology and HPV status. Complete response is defined as normal pathology, normal cytology and negative HPV."|6 month|Per protocol population. Patients with major protocol violations excluded.|||percentage of no. of patients analyzed|||Number
1469459|NCT00710593|Primary|HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-16 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
1469460|NCT00710593|Primary|HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)|The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-11 sero-negative at baseline (BL).|||mMU/mL||Standard Deviation|Geometric Mean
1469461|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||mMU/mL||Standard Deviation|Geometric Mean
1469462|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||mMU/mL||Standard Deviation|Geometric Mean
1469463|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24|Week 48|Subjects had received a third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
1469464|NCT00710593|Secondary|Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.|Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.|Week 48|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV sero-negative at baseline.|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
1469465|NCT00710593|Secondary|Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine|When a subject had at least one adverse event or sign/symptom during the study after doses 1, 2 or 3, and the event was possibly, probably, or definitely related to vaccine, this subject was considered to have had a vaccine-associated adverse event, sign and/or symptom.|Entry, Week 8, and Week 24|Subjects who had at least one event that was possibly, probably, or definitely related to vaccine.|||participants|||Number
1469466|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18|Subjects who had a >= 24 mMU/mL were classified as responders; subjects who had a less than < 24 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
1469467|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16|Subjects who had a >= 20 mMU/mL were classified as responders; subjects who had a less than < 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
1469468|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11|Subjects who had a >= 16 mMU/mL were classified as responders; subjects who had a less than < 16 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both HPV DNA negative and HPV Sero-Negative at baseline.|||participants|||Number
1469469|NCT00710593|Secondary|Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6|Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.|Week 28|Subjects had received third dose of vaccination who were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV Sero-Negative at baseline.|||participants|||Number
1469470|NCT00710593|Primary|HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)|The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.|Week 28|Subjects received the 3rd dose of vaccine and were both Human Papilloma Virus (HPV) Deoxyribonucleic Acid (DNA) negative and HPV-6 sero-negative at baseline (BL).|||Milli-Merck units/milliliter (mMU/mL)||Standard Deviation|Geometric Mean
1469471|NCT00710554|Secondary|Incidence of Adverse Events as a Measure of Subject's Safety.|The number of subjects that reported an adverse event in this study is presented.|19 weeks|All subjects were included in this analysis.|||participants|||Number
1469581|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1469472|NCT00710554|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)|Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.|Days 0-7 and Days 92-98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||number of tablets||Standard Deviation|Mean
1469473|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469474|NCT00710554|Secondary|Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)|The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469475|NCT00710554|Secondary|Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment|The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469476|NCT00710554|Secondary|Subject Global Impression of Change|A 7-point Likert-type scale was used, with the question: ‘Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below’ with the markers “very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse”. At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.|Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||participants|||Number
1469477|NCT00710554|Secondary|Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)|Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469478|NCT00710554|Secondary|Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)|Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5 s intervals, and recording the pain severity on a 0–10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes.A negative change from baseline indicates an improvement in score.|Day 7 and Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469479|NCT00710554|Secondary|Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469480|NCT00710554|Secondary|Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)|The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.|Day 7 to Day 98|The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469634|NCT00709592|Secondary|Donor Lymphocyte Infusion||2 year rate of DLI||||percentage of participants|||Number
1469708|NCT00708877|Primary|Transplant-related Mortality|Determined mortality-related transplant outcomes.|2 years|Entire cohort was used for analysis.|||participants|||Number
1469481|NCT00710554|Primary|Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)|"The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline."|Day 7 to Day 98|The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469482|NCT00710424|Primary|Number of Responders at the 30% Improvement Level at the End of Treatment|"A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 14 (last 7 days). The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period."|Day 0 - Day 98|All subjects who were randomised and received at least one actuation of study medication were included in the analysis. Subjects with no data during the primary period (i.e. unknown response) were included in the analysis, and were classed as non-responders.|||participants|||Number
1469483|NCT00710424|Secondary|Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment|Subjects rated their intoxication levels on a scale of 0-10, where 0 equals “no intoxication” and 10 equals “extreme intoxication”. A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469484|NCT00710424|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented.|Day 0 - Day 133|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1469485|NCT00710424|Secondary|Change From Baseline in the Use of Rescue Analgesia at the End of Treatment|The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated.|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||Tablets||Standard Deviation|Mean
1469486|NCT00710424|Secondary|Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale|The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469487|NCT00710424|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment|The brief pain inventory (short form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The pain severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469488|NCT00710424|Secondary|Subject Global Impression of Change at the End of Treatment|The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented.|Day 0 and Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||participants|||Number
1469489|NCT00710424|Secondary|Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment|"The sleep quality Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your sleep quality in the last 24 hours where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment)."|Day 0 - Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469490|NCT00710424|Secondary|Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period.|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1470697|NCT00703391|Primary|QTcF (QT Interval Corrected for Heart Rate by Fridericia’s Method)|QTcF interval greater than 450 ms|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1469491|NCT00710424|Primary|The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)|"The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis."|Day 0 to Day 98|The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.|||units on a scale||Standard Deviation|Mean
1469492|NCT00710385|Secondary|"Drug Liking"|"Participant's subjective ratings of how much they Like the dose they just received on a scale of 0 -100."|Peak (highest) rating obtained following drug administration throughout the entire 3 hr session||||units on a scale||Standard Error|Mean
1469493|NCT00710385|Primary|Drug's Breakpoint|"Measure of a drug's reinforcing effects. The Breakpoint is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested"|Single measurement taken following each of the 7 IV experimental doses|Heroin users, not seeking treatment|||number of clicks on a mouse||Standard Deviation|Mean
1469494|NCT00710203|Other Pre-specified|Evidence of Texture Irregularities|The physician assessed evidence of texture irregularities.|6 to 12 weeks||||lesions|||Number
1469495|NCT00710203|Other Pre-specified|Evidence of Scar|The physician assessed evidence of scar.|6 to 12 weeks||||lesions|||Number
1469496|NCT00710203|Other Pre-specified|Evidence of Hyperpigmentation|The physician assessed evidence of hyperpigmentation.|6 to 12 weeks||||lesions|||Number
1469497|NCT00710203|Other Pre-specified|Evidence of Hypopigmentation|The physician assessed evidence of hypopigmentation.|6 to 12 weeks||||lesions|||Number
1469498|NCT00710203|Primary|Percent Clearance of All Lesions|The physician assessed percent clearance of all treated lesions and the control lesion.|6 to 12 weeks||||percentage of lesion clearance|Participants|Standard Deviation|Mean
1469499|NCT00710034|Secondary|Product Effect on Biomarkers of Exposure and Toxicity|Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).|Baseline and Week 4 post smoking substitution||||pmol//mg creatinine||Standard Deviation|Mean
1469500|NCT00710034|Secondary|Products Effect on Withdrawal Symptoms.|Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.|Week 1-12 post switching|Using assigned product only. The numbers of subjects that were only using the assigned product were 40 and 37 for nicotine gum and oral tobacco respectively at week 12. Analysis was conducted from weeks 1-12 post-switching.|||units on a scale||Standard Deviation|Mean
1469501|NCT00710034|Primary|Number of Products Used|Pieces of product per week at mid intervention|6 weeks post smoking substitution||||Pieces per week||Standard Deviation|Mean
1469502|NCT00710034|Primary|Number of Cigarettes Smoked|Cigarettes per day at mid intervention|6 weeks post cigarette substitution||||cigarettes per day||Standard Deviation|Mean
1469503|NCT00710034|Primary|Product Effect on Complete Substitution for Smoking|Number of subjects using only the assigned study product at week 6|6 week post smoking substitution||||participants|||Number
1469504|NCT00710021|Secondary|Percent of Participants With Adverse Events of Grade 3 or Above|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From start of study treatment through Week 12|Safety|||Percent of participants|||Number
1469505|NCT00710021|Secondary|Renal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Renal-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469506|NCT00710021|Secondary|Ophthalmic BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Ophthalmic-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469507|NCT00710021|Secondary|Neuropsychiatric BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Neuropsychiatric-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469848|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 2|Visit 2 log10 PC20 after receiving 2 weeks of Flovent|Visit 2:12 hours after last dose of Flovent|All participants who had a methacholine challenge at Visit 2. All participants had received Flovent for 2 weeks.|||log10 mg/mL||Standard Deviation|Mean
1469508|NCT00710021|Secondary|Musculoskeletal BILAG Status at Week 12|Outcome measure description: The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Musculoskeletal-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469509|NCT00710021|Secondary|Mucocutaneous BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Mucocutaneous-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469510|NCT00710021|Secondary|Hematological BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Hematological-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469511|NCT00710021|Secondary|Gastrointestinal BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Gastrointestinal-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469512|NCT00710021|Secondary|Constitutional BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Constitutional-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469513|NCT00710021|Secondary|Cardiorespiratory BILAG Status at Week 12|The British Isles Lupus Assessment Group (BILAG) assessment gives a grade for each of 9 body systems (e.g., domains). Grades reflect systemic lupus erythematosus disease activity as follows: A (severe), B (moderate), C (mild), D (inactive at present but previously affected), E (inactive and system never involved). To be randomized, subjects had to have mild or inactive disease (C,D,E) in all but the mucocutaneous system in which B(moderate) disease was also allowed. The percent of subjects experiencing A or B level activity at Week 12 is assessed for the “Cardiorespiratory-specific” body system.|Week 12|Modified Intent-to-Treat with available data|||Percent with grade A or B|||Number
1469514|NCT00710021|Secondary|Change in SELENA-SLEDAI Total Score From Baseline to Week 12|The modified Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. For this study, the SELENA-SLEDAI score was modified to include proteinuria defined by dipstick rather than 24 hour urine. Positive change in the SELENA-SLEDAI score indicate increased disease activity.|0, Week 12|Modified Intent-to-Treat with available data|||Change in Scores on a Scale||Standard Deviation|Mean
1469515|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 6|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 6|Modified Intent-to-Treat with available data|||Percent of participants|||Number
1469516|NCT00710021|Secondary|Change in Status for Anti-double-stranded DNA Autoantibody From Baseline to Week 12|Patients with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Change in status (+ or -) from baseline is evaluated.|0, Week 12|Modified Intent-to-Treat with available data|||Percent of participants|||Number
1469517|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 6|Outcome measure description: C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1469849|NCT00708214|Secondary|Best Change From Baseline in ECOG Performance Status|Best change from baseline in ECOG (Eastern Cooperative Oncology Group) performance status. ECOG is measured as score between 0 (fully active) and 5 (dead). Improvement is a decrease in ECOG score from baseline of at least 1. Deterioration is an increase in ECOG score from baseline of at least 1|baseline till end of treatment||||participants|||Number
1469518|NCT00710021|Secondary|Change in Serum C4 Level From Baseline to Week 12|C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range for males is 12 to 72 mg/dL and the normal range for females is 13 to 75 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity. An increase in C4 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1469519|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 6|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 6 is represented as a positive value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1469520|NCT00710021|Secondary|Change in Serum C3 Level From Baseline to Week 12|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 75 to 135 mg/dL. Patients with active systemic lupus erythematosus may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate disease activity. An increase in C3 from baseline to Week 12 is represented as a positive value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||mg/dL||Standard Deviation|Mean
1469521|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 6|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1469522|NCT00710021|Secondary|qRT-PCR Fold Change in Mx1 Gene Expression From Baseline to Week 12|The Mx1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes for the homolog of mouse myxovirus (influenza virus) resistance 1 protein. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1469523|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 6|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1469524|NCT00710021|Secondary|qRT-PCR Fold Change in Ifi44 Gene Expression From Baseline to Week 12|The Ifi44 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes interferon-induced protein 44. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1469525|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 6|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. It encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 6 is represented as a negative value (and vice versa).|0, Week 6|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1469526|NCT00710021|Secondary|qRT-PCR Fold Change in Ifit1 Gene Expression From Baseline to Week 12|The Ifit1 gene is one of three genes included in the definition of the alpha-interferon signature used for this study. This gene encodes an interferon-induced protein with tetratricopeptide repeats. Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure gene expression in peripheral blood mononuclear cells obtained by blood draw. Gene expression is quantified as “fold change” relative to normal controls and is computed using a comparative CT (threshold cycle) method. A study hypothesis was that expression of alpha-interferon signature genes would decrease with increasing vitamin D levels. A decrease in gene expression from baseline to Week 12 is represented as a negative value (and vice versa).|0, Week 12|Modified Intent-to-Treat with available data|||qRT-PCR fold change||Standard Deviation|Mean
1469635|NCT00709592|Secondary|Relapse|Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans.|2 year relapse rate (%)||||Percent patients relapsing|||Number
1469527|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 6|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.|||Percent of participants|||Number
1469528|NCT00710021|Secondary|Percent of Participants With IFN Alpha Signature at Week 12|An Interferon (IFN) Alpha signature is defined as: expression of Mx1, Ifit1, or Ifi44 at a level greater than or equal to 4 standard deviations above the mean of a set of normal controls, or expression of 2 of the 3 genes at a level greater than or equal to 2 standard deviations above the mean of a set of normal controls. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were assumed as signatures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU) who did not have a signature were included in the study.|||Percent of participants|||Number
1469529|NCT00710021|Secondary|Percent of Participants With an IFN Alpha Signature Response at Week 6|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 6|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.|||Percent of participants|||Number
1469530|NCT00710021|Primary|Percent of Participants With an IFN Alpha Signature Response at Week 12|Presence of an Interferon (IFN) Alpha signature response is defined as: a reduction in expression from baseline (Screening) of at least 50% for 1 of 3 IFN Alpha responsive genes (Ifit1, Ifi44, Mx1) with concurrent expression in the remaining 2 genes at a level not more than 25% above baseline, or a reduction in expression from baseline of at least 25% for 2 of the 3 IFN Alpha responsive genes with concurrent expression in the third gene at a level of no more than 25% above baseline. Gene expression was measured on peripheral blood samples using qRT-PCR. Missing data were considered as response failures during calculation.|0, Week 12|Modified Intent-to-Treat. Although presence of a positive IFN Alpha Signature at the Screening visit was an entry criterion for the study, 8 subjects (4 Placebo, 2 Vitamin D3 2000 IU, 2 Vitamin D3 4000 IU ) who did not have a signature were included in the study.|||Percent of participants|||Number
1469531|NCT00709956|Secondary|Borg Dyspnea Score|"The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled extremely severe, or the worst possible dyspnea imaginable. Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.|||scores on a scale||Standard Deviation|Mean
1469532|NCT00709956|Primary|6-minute-walk Distance (6MWD)|"The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk.~It was conducted by a trained member of the site staff who was listed on the site’s delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization."|Study day 2 or study day 3|The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.|||meters||95% Confidence Interval|Least Squares Mean
1469533|NCT00709891|Secondary|Percentage of Participants With a Diagnosis of ≥ CIN3|A diagnosis of ≥ CIN3 (cervical intraepithelial neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the study (up to 5 years, 1 month)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).|||Percentage of participants|||Number
1469534|NCT00709891|Primary|Percentage of Participants With a Diagnosis of ≥ CIN2|A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review.|Baseline to the end of the Baseline period (up to 12 weeks)|Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).|||Percentage of participants|||Number
1469535|NCT00709878|Primary|Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.||6 months||||Total number of cases|||Number
1469536|NCT00709852|Secondary|Percentage of Lesion Enhancement From Unenhanced to Combined Unenhanced/Enhanced for Gadobutrol and Gadoteridol by Blinded Readers|From the quantitative signal intensity values assessed by the BR, the percentage of lesion enhancement from unenhanced to combined unenhanced/enhanced was calculated.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of lesion enhancement||Standard Deviation|Mean
1469636|NCT00709592|Secondary|Event-free Survival||2 years||||percentage of participants|||Number
1469637|NCT00709592|Secondary|Treatment Related Mortality||Day 100||||percentage of patients|||Number
1469638|NCT00709592|Secondary|Survival||2-year survival rate (%)||||percentage of patient surviving|||Number
1469639|NCT00709592|Secondary|Engraftment of Donor Hematopoietic Stem Cells, as Measured by Neutrophil and Platelet Counts||12 day median|||||||
1469537|NCT00709852|Secondary|Assessment of the Number of Contrast-enhanced Lesions for Gadobutrol and Gadoteridol by Blinded Readers|Two BRs independently provided the number of contrast-enhanced lesions for gadobutrol and gadoteridol. In cases of disagreement between the readers, an independent adjudicator provided the number of contrast-enhanced lesions. The adjudicator results were used in the analysis in the cases of disagreement between the original readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1469538|NCT00709852|Secondary|Percentage of Participants for Which Blinded Readers Said Image Quality Was Higher|Percentage of participants for which blinded readers said image quality was higher|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469539|NCT00709852|Secondary|Comparison of Image Quality Between Gadobutrol and Gadoteridol by Blinded Readers|The BRs evaluated the relative image quality of the gadobutrol-enhanced T1w MR images and the gadoteridol-enhanced T1w MR images in a paired fashion on a 5-point scale where 1 = image on right was worse, 2 = image on right was slightly worse, 3 = both images were the same, 4 = image on right was slightly better, and 5 = image on right was better.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469540|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the combined unenhanced/gadobutrol-enhanced MR image sets and the combined unenhanced/gadoteridol MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469541|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadoteridol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469542|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The investigator recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/gadobutrol-enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469543|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469544|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469545|NCT00709852|Secondary|Diagnostic Confidence for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The BRs recorded his/her confidence in diagnosis for the unenhanced MR image set and the combined unenhanced/enhanced MR image sets. The degree of confidence was rated on a 4-point scale where 1 = not confident and 4 = very confident. The AR score was the mean of the means of the 3 BRs.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469546|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469547|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469640|NCT00709592|Primary|The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine.|A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).|Up to 9 months following transplant||||participants|||Number
1469548|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469549|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469550|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469551|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469552|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469553|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469554|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469555|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469641|NCT00709319|Primary|Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months|Change in thickness is followup thickness minus baseline thickness.|Baseline to 6 months||||participants|||Number
1469556|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects malignant lesions as defined by the independent truth committee|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469557|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469558|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469559|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469560|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The presence of malignant lesions was derived from the diagnoses given by the investigator on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469561|NCT00709852|Secondary|Specificity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469562|NCT00709852|Secondary|Sensitivity of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects malignant lesions as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469563|NCT00709852|Secondary|Accuracy of Detection of Malignant Lesions (ML) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The presence of malignant lesions was derived from the diagnoses given on the evaluation of the unenhanced image set and the combined unenhanced/enhanced image sets. The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs. The final clinical diagnosis was provided by an independent truth committee not using the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of malignant lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469642|NCT00709319|Primary|Percent of Participants With Change in Visual Acuity From Baseline to Six Months||Baseline to 6 months||||Percentage of Participants||95% Confidence Interval|Number
1469643|NCT00709319|Secondary|Surgical Complications From Baseline to Six Months|Including intraoperative and perioperative medical complications. Same subject could have more than one complication|Baseline to 6 months||||Participants|||Number
1469564|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469565|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469566|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (Gadobutrol-enhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469567|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469568|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469569|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadoteridol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469570|NCT00709852|Secondary|Specificity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Specificity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly excludes abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469571|NCT00709852|Secondary|Sensitivity of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Sensitivity = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) correctly detects abnormal brain tissue as defined by the independent truth committee.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469644|NCT00709319|Primary|Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline|Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.|Baseline to 6 Months||||microns||Inter-Quartile Range|Median
1469572|NCT00709852|Secondary|Accuracy of Detection of Normal/Abnormal Brain Tissue for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader Using T1-weighted (T1w) Images|The majority reader diagnosis was the diagnosis provided by at least 2 of the 3 BRs for the T1w assessment (normal or abnormal). The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. Accuracy = percentage of participants for which the imaging modality (unenhanced or Gadobutrol-enhanced) matches the standard of truth for the presence or absence of abnormal brain tissue.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469573|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the clinical investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1469574|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the combined unenhanced/gadoteridol-enhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1469575|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1469576|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadoteridol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1469577|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the investigator diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1469578|NCT00709852|Secondary|Percentage (Per.) of the Exact Diagnostic Matches (Accuracy of Diagnosis) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Majority Reader|The majority reader diagnosis was the diagnosis provided by at least 2 of the BRs. The final clinical diagnosis was provided by an independent truth committee following evaluation of findings from referral through a 3-month follow-up period, not including the study-specific MR image sets. The accuracy of the majority reader diagnoses for the combined unenhanced/gadobutrol-enhanced and the unenhanced MR images were evaluated for consistency with the final clinical diagnosis.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||per. of the exact diagnostic matches|||Number
1469579|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469580|NCT00709852|Secondary|Scores for Contrast Enhancement, Border Delineation and Internal Morphology for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469582|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469583|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469584|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469585|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1469586|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadoteridol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469587|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469588|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469589|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1469590|NCT00709852|Secondary|Scores for Two Visualization Parameters (Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator|The clinical investigators evaluated the images from the unenhanced MRI and the images from the combined unenhanced and gadobutrol-enhanced MRIs. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469591|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the combined unenhanced and gadobutrol-enhanced MRIs in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469645|NCT00709319|Primary|Visual Acuity|Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.|Baseline to 6 months||||Units on a scale||Inter-Quartile Range|Median
1469592|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadoteridol-enhanced MRI or for Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadoteridol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469593|NCT00709852|Secondary|Percentage of Participants With More Lesions Detected for Combined Unenhanced/Gadobutrol-enhanced MRI or for Unenhanced MRI by Blinded Readers|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another and determined the number of lesion from each.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||percentage of participants|||Number
1469594|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1469595|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Combined Unenhanced/Gadoteridol-enhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers.|Up to 2 hours after injection of gadobutrol or gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469596|NCT00709852|Secondary|Number of Lesions for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1469597|NCT00709852|Secondary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadoteridol-enhanced MRI Compared to Unenhanced MRI by Average Reader|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadoteridol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469598|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469599|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469600|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469601|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469646|NCT00709306|Primary|Sun Stage of Change at 12 Months|The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).|12 months||||Participants|||Count of Participants
1469602|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469603|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469604|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469605|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Normal Structures for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469606|NCT00709852|Primary|Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers|The blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||lesions||Standard Deviation|Mean
1469607|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)|The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469608|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)|BR3 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469609|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)|BR2 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|All participants in the FAS with assessments for this outcome measure.|||scores on a scale||Standard Deviation|Mean
1469647|NCT00709306|Primary|Sun Stage of Change at 3 Months|The Sun Stage of Change (SOC) Scale has 4 items asking participants whether they have been protecting their skin for the past year (maintenance), if they protect their skin now (action), whether they intend to protect their skin in the next 30 days (preparation), whether they intend to protect their skin in the next year (contemplation), or none of the above (pre-contemplation).|3 months||||Participants|||Count of Participants
1469850|NCT00708214|Secondary|Change From Baseline in Ca15.3|Change from baseline in Ca15.3 tumor marker levels|baseline and day 29|Analysis of all treatment arms combined for tumor marker analysis.|||percentage of baseline level||Full Range|Median
1469610|NCT00709852|Primary|Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)|BR1 evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.|Up to 2 hours after injection of gadobutrol|The full analysis set (FAS); which used data from all participants for whom data and images were available for the unenhanced MRI, combined unenhanced and gadobutrol-enhanced MRI, and combined unenhanced and gadoteridol-enhanced MRI, excluding the sample participants (the first participant from each study site).|||scores on a scale||Standard Deviation|Mean
1469611|NCT00709826|Primary|Progression Free Survival|Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|Randomization then every other cycle|A 1-sided log rank test was used to achieve 80% power at an α=0.20 significance level to detect a difference of 0.16 between the proportions of patients who were progression free in AP/EG (0.35) and P/EG (0.19) after 9 months; an overall sample size of approximately 110 patients (73 in AP/EG and 37 in P/EG) was randomized in a 2:1 ratio.|||Months||95% Confidence Interval|Median
1469612|NCT00709826|Secondary|Overall Survival||Randomization then every other cycle||||Months||95% Confidence Interval|Median
1469613|NCT00709761|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the start of treatment until the earliest date of disease progression or death due to any cause, if sooner.|Start of treatment to disease progression or death (up to Week 131)|ITT Population|||weeks||95% Confidence Interval|Median
1469614|NCT00709761|Secondary|Time to Progression (TTP)|TTP was defined as the interval between the start of treatment until the earliest date of disease progression or death due to breast cancer.|Start of treatment to disease progression or death (up to Week 131)|ITT Population|||weeks||95% Confidence Interval|Median
1469615|NCT00709761|Secondary|Time to Response (TTR)|TTR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first).|Start of treatment to first documented response (CR or PR) (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.|||weeks||95% Confidence Interval|Median
1469616|NCT00709761|Secondary|Duration of Response (DOR)|DOR was defined for the subset of participants who showed a confirmed CR or PR, as the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.|First documented response (CR or PR) to disease progression or death (up to Week 131)|ITT Population. Only those participants experiencing a CR or a PR were analyzed.|||weeks||95% Confidence Interval|Median
1469617|NCT00709761|Secondary|Overall Survival (OS)|OS was defined as the time from the start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of last contact. OS could not be analyzed because only 13 participants had died as of data cut off, and data were not mature (greater than 75% of the participants were censored for the endpoint).|Start of treatment to death (up to Week 131)|ITT Population||||||
1469618|NCT00709761|Primary|Overall Tumor Response (OR)|OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.|Start of treatment to disease progression or death or discontinuation from study or at least 28 days after last dose (up to Week 131)|Intent-to-Treat (ITT) Population: all participants who received at least one dose of investigational product|||percentage of participants|||Number
1469619|NCT00709735|Secondary|Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score|IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 2 IES-R total score from the Day 8 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.|Day 2 (Baseline ) and Day 8|All randomized participants who completed the study.|||score on a scale||Standard Deviation|Mean
1469620|NCT00709735|Primary|Physiological Posterior Probability of Posttraumatic Stress Disorder (PTSD) as Determined From Psychophysiologic Responses During Script-Driven Traumatic Memory Recollection|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses during script-driven imagery of traumatic combat events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator and left lateral frontalis facial muscle electromyogram (EMG) responses in microVolts. Responses for the two traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant’s posterior probability of being classified as PTSD.|Day 8|All randomized participants who completed the study.|||percent probability||Standard Deviation|Mean
1469621|NCT00709722|Secondary|Treatment Days With Corticosteroids of <= 7.5 mg/Day|"Entry to the study was permitted for patients with doses of oral corticosteroids (OCS) of <= 1.0 mg/kg/day (maximum dose 80 mg/day).~OCS dosage was maintained, decreased or increased according to the response to DSG.~The number of days on which the OCS dose was <= 7.5 mg/day was counted in each cycle."|1st and 9th Cycle|ITT population|||Days||Full Range|Mean
1469622|NCT00709722|Secondary|SELENA-SLEDAI Score|The “Safety of Estrogen in Lupus Erythematosus National Assessment – systemic lupus erythematosus disease activity index' (SELENA-SLEDAI) document the current activity of SLE/LN. It contains 24 items (descriptors), which are differently weighed. The score has a total range of 0 - 105. As a maximum 105 score points can be reached meaning the worst disease activity.|Screening, the last day of Cycles 4, 6 and 9, up to 27 weeks|ITT population|||Score on a scale||Full Range|Mean
1469623|NCT00709722|Primary|Complete and Partial Response Rate|A four-point scale was defined: complete response (CR), partial response (PR), stable disease (SD) or treatment failure (TF). The response criteria were defined prior to the start of the study: for a CR, PR or SD prednisone had to be decreased to <= 7.5 mg/day, a higher dosage was automatically classified as TF. The presence of urinary erythrocyte or granular casts excluded CR. As the baseline activity of every patient is different, it was necessary to define baseline proteinuria (g/24 h) or kidney function (estimated glomerular filtration rate) as the reference value for the definition of response for every patient individually. The baseline was defined as the renal function and proteinuria level before the onset of the recent LN flare which qualified the patient for the study. Response was determined as the ratio of the proteinuria or kidney function at cycle 4, 6 or 9 to the baseline values of the individual patient.|Screening, Day 14 of Cycles 4, 6 and 9, up to 27 weeks|ITT population|||Percentage of participants|||Number
1469624|NCT00709696|Primary|Nicotine Withdrawal Scale|Scale is equal to days subject did not smoke Scale is 0-5 0 being no days 5 being did not quit at all|21 days|Treatment-seeking smokers|||units on a scale||Standard Deviation|Mean
1469625|NCT00709618|Secondary|Overall Survival|OS is defined as the time from the start of study treatment to the date of death. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Overall survival was not assessed because the study was terminated due to low screening and a low enrollment rate after 3 years. There were no-survival follow-up visits required.|From the start of study treatment to the date of death, assessed for up to 3 years|||||||
1469626|NCT00709618|Secondary|Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine|Qualitative and quantitative toxicities associated with the combination of lapatinib and vinorelbine during the study are those adverse events (AEs) that are judged to be related to the study treatment by the investigator. Those AEs occuring in more than 5 participants in the ITT Population are listed here.|From the start of study medication until disease progression, assessed every 4 weeks for up to 2 years|ITT Population|||participants|||Number
1469627|NCT00709618|Secondary|Time to Progression (TTP), as Assessed by the Investigator|TTP is defined as the time from the start of treatment until the earliest date of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to breast cancer, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).|||weeks||95% Confidence Interval|Median
1469628|NCT00709618|Secondary|Time to Response, as Assessed by the Investigator|Time to response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||weeks||95% Confidence Interval|Median
1469629|NCT00709618|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the first documented evidence of CR or PR until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to any cause, if sooner.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Only participants with a confirmed CR/PR were assessed for duration of response. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||weeks||95% Confidence Interval|Median
1469630|NCT00709618|Secondary|Progression-Free Survival (PFS), as Assessed by the Investigator|PFS is defined as the time from the start of treatment until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|ITT Population. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off. Censoring is defined as being alive without the event of interest (progression or death).|||weeks||95% Confidence Interval|Median
1469631|NCT00709618|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesions)/recurrence.|From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years|Intent-to-Treat (ITT) Population: participants who received >=1 dose of investigational product. To be assigned a status of PR/CR, a confirmatory disease assessment (including bone scan/positron emission tomography scan documenting that progression/ new lesions hasn't occurred) had to be performed >=4 weeks after response criteria were first met.|||participants|||Number
1469632|NCT00709592|Secondary|Chronic Graft-Versus-Host Disease (GVHD)||2 year GVHD rate||||percentage of participants|||Number
1469633|NCT00709592|Secondary|Acute Graft-Versus-Host Disease (GVHD)||2 year rate (%)||||percentage of participant|||Number
1469649|NCT00709124|Secondary|Subgroup Analysis|"For patients with >= 7 days of mechanical ventilation, we will compare the 2 groups for the following outcomes: Lower extremity muscle strength, mean change in whole body muscle strength score from baseline to ICU discharge, mean change in whole body muscle strength score from baseline to hospital discharge, and whole body muscle strength score at ICU discharge and at hospital discharge.~Each muscle group is assessed bilaterally (scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). There are three muscle groups assessed bilaterally for lower extremity (hip flexion, knee extension, and ankle dorsiflexion) (score range 0-30, higher score is better i.e. stronger); while for whole body strength assessment (score range 0-360, higher score is better), the following additional muscles are assessed: shoulder abduction, elbow flexion and wrist extension.~The scores are then summed for each patient at each time point."|ICU and hospital discharge and change over time|This was an a priori subgroup analyses of patients who had mechanical ventilation duration >=7 days. Not all participants could be evaluated at each time point (e.g. cognitive status) and this explains the different sample sizes for each outcome.|||muscle strength score (higher is better)||Standard Deviation|Mean
1469650|NCT00709124|Secondary|ICU Delirium|Proportion of ICU days the patient had delirium|During ICU stay - on days with study (NMES/Sham) session||||Mean % delirious days|Days of session|Standard Deviation|Mean
1469651|NCT00709124|Secondary|Mean Change in Subject’s Lower Extremity Muscle Strength Composite Score From Baseline|"The mean change of the sum of the lower limb strength scores between awakening and ICU discharge and between ICU discharge and hospital discharge.~Three lower limb muscle groups are assessed bilaterally (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength]). The scores are then summed for each patient at each time point (range 0 -30, higher score is better)."|At ICU and Hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Score||Standard Deviation|Mean
1469652|NCT00709124|Secondary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps)|Measured via manual muscle strength test using a composite Medical Research Council (MRC) score with each muscle group rated with score ranging from 0 (no visible or noticeable contraction of the muscle) to 5 (maximum strength). The sum of the scores for the lower limb muscle groups can range from 0 to 30 (higher score is better)|At hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Score||Standard Deviation|Mean
1469653|NCT00709124|Secondary|Hospital Discharge Destination (e.g., Home, Rehab Facility)|Discharge location after hospital stay.|Hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||Participants|||Count of Participants
1469654|NCT00709124|Secondary|Total Hospital Charges|The total dollar amount of charges from hospital stay|Hospital discharge||||US dollars||Standard Deviation|Mean
1469655|NCT00709124|Secondary|ICU and In-hospital Mortality|The number of patients who died in the ICU and those who died by hospital discharge.|ICU discharge and Hospital discharge||||Participants|||Count of Participants
1469656|NCT00709124|Secondary|ICU and Hospital Length of Stay|The number of days that the patient was in the ICU and hospital, respectively.|ICU and Hospital discharge||||days||Standard Deviation|Mean
1469657|NCT00709124|Secondary|Duration of Mechanical Ventilation|The number of days the patient was on mechanical ventilation.|Until hospital discharge||||days||Standard Deviation|Mean
1469658|NCT00709124|Secondary|Functional Status Measured Using Functional Status Score for the Intensive Care Unit|Evaluates a patient’s physical function in the ICU setting. Each task is scored, ranging from 0 (unable to perform) to 7 (complete independence).The total score ranges from 0-35, with higher scores indicating better physical functioning.|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||FSS-ICU Score||Standard Deviation|Mean
1469659|NCT00709124|Secondary|Respiratory Muscle Strength|Measured using maximal inspiratory pressure (MIP) measurements that is then compared to predicted values for each participant (i.e., % predicted)|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||% predicted||Standard Deviation|Mean
1469660|NCT00709124|Secondary|Hand Grip Strength|Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield % predicted)|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||% predicted||Standard Deviation|Mean
1469661|NCT00709124|Secondary|Overall Body Strength|Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||MRC Composite Score||Standard Deviation|Mean
1469662|NCT00709124|Secondary|Individual Muscle Strength Using Handheld Dynamometry: Tibialis Anterior, Gastrocnemius, and Quadriceps Muscle Strength|Strength (in pounds) - measured via handheld dynamometry of tibialis anterior, gastrocnemius, and quadriceps|ICU and hospital discharge|Assessments can only be done on patients who were alive and were able to do participate in the assessment|||pounds||Standard Deviation|Mean
1469663|NCT00709124|Primary|Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score|Range 0 to 30 with higher score better. The composite score is a simple sum of the individual scores from the 3 bilateral muscle groups|At hospital discharge||||units (range 0-30; higher is better)||Standard Deviation|Mean
1469664|NCT00709111|Secondary|Drug Adherence Assessed as Number of Missed Doses Over a 4-day Recall|Self-reported MVC adherence data were based on a four-day (8 expected doses) recall. Based on the wording of the Self Report case report form (CRF), participants reporting that they were currently taking MVC that then failed to complete the record of the number of missed doses were assumed to have no missed doses to report. Missing adherence assessments at a time point of interest were ignored and only those participants completing an adherence assessment at least one time point of interest were included.|At weeks 4, 12, and 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.|||doses missed||Full Range|Median
1469665|NCT00709111|Secondary|Proportion of Participants With Detectable HIV-1 Viremia as Measured by Single Copy Assay (SCA)|A subject was considered detectable at a specific week if HIV-1 RNA by SCA >=1 copy/ml.|At weeks -1 (pre-entry), 0 (entry), 12, 22, 24, and 36|As-treated: Participants who initiated treatment were included. Through week 24, follow-up while receiving MVC without change in background regimen were included. For week 36, only results obtained while receiving background regimen were included. One subject who had a large rise (blip) in viral load at week 24 was excluded.|||proportion of participants|||Number
1469666|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1469667|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||ng/ml||90% Confidence Interval|Median
1469668|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||pg/ml||90% Confidence Interval|Median
1469669|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mg/dl||90% Confidence Interval|Median
1469670|NCT00709111|Secondary|Change in D-dimer|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1469671|NCT00709111|Secondary|Change in ICAM-1, Plasma P-selectin, sTNFRII, and MMP-9|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||ng/ml||90% Confidence Interval|Median
1469672|NCT00709111|Secondary|Change in IL-6, MCP-1, MCP-2, and Plasma CD40L|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||pg/ml||90% Confidence Interval|Median
1469673|NCT00709111|Secondary|Change in Hs-CRP|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mg/dl||90% Confidence Interval|Median
1469674|NCT00709111|Secondary|Change in D-dimer|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1469675|NCT00709111|Secondary|Change in Intercellular Cell Adhesion Molecule (ICAM)-1, Plasma P-selectin, Soluble TNFRII (sTNFRII), and Matrix Metalloproteinase (MMP)-9|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||ng/ml||90% Confidence Interval|Median
1469676|NCT00709111|Secondary|Change in Interleukin (IL)-6, Monocyte Chemoattractant Protein (MCP)-1, MCP-2, and Plasma CD40 Ligand (CD40L)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||pg/ml||90% Confidence Interval|Median
1469677|NCT00709111|Secondary|Change in High Sensitivity C-reactive Protein (Hs-CRP)|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mg/dl||90% Confidence Interval|Median
1469678|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1469679|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values). Soluble CD14 is a marker of gut microbial translocation.|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1469680|NCT00709111|Secondary|Change in Soluble CD14|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values). Soluble CD14 is a marker of gut microbial translocation.|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||mcg/ml||90% Confidence Interval|Median
1469681|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
1469682|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 48 result (average of week 46 and week 48) minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 result or a week 48 result obtained while receiving background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
1469683|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
1469684|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as week 36 result minus the week 24 result (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 result obtained while receiving background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
1469685|NCT00709111|Secondary|Change in Percentage of CD8+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||% of CD8+ T-cells||90% Confidence Interval|Median
1469686|NCT00709111|Secondary|Change in Percentage of CD4+ T-cells That Are: naïve (%CD45RA+CCR7+), Central Memory (%CD45RA-CCR7+), Effector Memory (%CD45RA-CCR7-), Effector (%CD45RA+CCR7-), %HLA-DR+CD38+, %CD38+, %Ki67+, %caspase3+, %Bcl-2-, and %CD57+|Change was calculated as the week 24 result (average of the week 22 and week 24 values) minus the baseline result (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 result or a week 24 result obtained while receiving MVC without change in background regimen were included.|||% of CD4+ T-cells||90% Confidence Interval|Median
1469687|NCT00709111|Secondary|Number of Subjects Who Experience a Grade 2, 3 or 4 Signs and Symptoms, Grade 3 or 4 Laboratory Abnormalities, or Death.|Events with date of onset or specimen date prior to first dose of MVC or after the last dose of MVC were excluded. Signs and symptoms with a date of onset the same as the first dose of MVC were excluded if confirmed by the site to be before the first dose. Lab abnormalities with the date of specimen the same as the date of the first dose of MVC were excluded on the assumption that the specimen was drawn before the first dose. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.|From baseline through week 24|As-treated: Participants who initiated treatment were included. Follow-up while receiving MVC without change in background regimen were included.|||participants|||Number
1469688|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 48 CD4 percentage (average of week 46 and week 48) minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4 percentage or a week 48 CD4 percentage obtained while receiving background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
1469689|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as week 36 CD4 percentage minus the week 24 CD4 percentage (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4 percentage obtained while receiving background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
1469690|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4 Percentage Slopes to Corresponding Within-subject CD4 Percentage Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4 percentage (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.|||% of total lymphocytes/year||90% Confidence Interval|Mean
1470698|NCT00703391|Primary|Leucocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||10**9/L||Standard Deviation|Mean
1469691|NCT00709111|Secondary|Within-subject CD4 Percentage Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4 percentage available at least through visit week 22 while receiving MVC without change in background regimen were included. Four of these subjects did not have pre-treatment (from at least 48 weeks prior to study entry) CD4 percentage results available.|||% of total lymphocytes/year||90% Confidence Interval|Mean
1469692|NCT00709111|Secondary|Change in CD4 Percentage|Change was calculated as the week 24 CD4 percentage (average of the week 22 and week 24 values) minus the baseline CD4 percentage (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4 percentage or a week 24 CD4 percentage obtained while receiving MVC without change in background regimen were included.|||% of total lymphocytes||90% Confidence Interval|Median
1469693|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 48 CD4+ T-cell count (average of week 46 and week 48) minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 48|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with either a week 46 CD4+ T-cell count or a week 48 CD4+ T-cell count obtained while receiving background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
1469694|NCT00709111|Secondary|Change in CD4+ T-cell Count|Change was calculated as week 36 CD4+ T-cell count minus the week 24 CD4+ T-cell count (average of the week 22 and week 24 values).|From week 24 to week 36|As-treated: Only participants that were included in the primary week 24 analysis, i.e. change from baseline to week 24, and with a week 36 CD4+ T-cell count obtained while receiving background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
1469695|NCT00709111|Secondary|Change From Within-subject Pre-treatment CD4+ T-cell Count Slopes to Corresponding Within-subject CD4+ T-cell Count Slopes From Baseline Through Week 24|The estimated mean change in slopes was summarized across the population by using generalized estimating equations. Pre-treatment CD4+ T-cell counts (from at least 48 weeks prior to study entry) were recorded at screening from patient source documentation. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From pre-treatment through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.|||cells/mm^3/year||90% Confidence Interval|Mean
1469696|NCT00709111|Secondary|Within-subject CD4+ T-cell Count Slopes|The estimated mean slope was summarized across the population by using generalized estimating equations. Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline through week 24|As-treated: Participants with CD4+ T-cell counts available at least through visit week 22 while receiving MVC without change in background regimen were included.|||cells/mm^3/year||90% Confidence Interval|Mean
1469697|NCT00709111|Secondary|Proportion of Participants Achieving a 50-cell Increase in CD4+ T-cell Count|Baseline was defined as the average of pre-entry and entry values. Week 24 was defined as the average of the week 22 and week 24 values.|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.|||proportion of participants||90% Confidence Interval|Number
1469698|NCT00709111|Primary|Change in CD4+ T-cell Count|Change was calculated as the week 24 CD4+ T-cell count (average of the week 22 and week 24 values) minus the baseline CD4+ T-cell count (average of pre-entry and entry values).|From baseline to week 24|As-treated: Only participants with either a week 22 CD4+ T-cell count or a week 24 CD4+ T-cell count obtained while receiving MVC without change in background regimen were included.|||cells/mm^3||90% Confidence Interval|Median
1469699|NCT00709098|Other Pre-specified|Average Inhalation Time|Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)|12 weeks|All treated population|||minutes||Standard Deviation|Mean
1469700|NCT00709098|Primary|Patients With Adverse Events Leading to Premature Discontinuation of Study Drug|Number of patients with adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.||||participants|||Number
1469701|NCT00709098|Primary|Adverse Events Leading to Premature Discontinuation of Study Drug|Number of adverse events leading to discontinuation of study treatment|Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.|Safety population|||adverse events|||Number
1469702|NCT00709098|Primary|Treatment-emergent Serious Adverse Events|Number of serious adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population|||serious adverse events|||Number
1469703|NCT00709098|Primary|Treatment-emergent Adverse Events|Number of adverse events|Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.|Safety population|||adverse events|||Number
1469704|NCT00709059|Primary|Number of Study Participants Who Had a Virological Response (VR) at Week-72|"VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test.~Participants who dropped out or were withdrawn from treatment were considered not to respond."|Treatment Week 72|Full Analysis Set (FAS)was analyzed. FAS consisted of all participants in the intent-to-treat population wih non-missing viral response at Week 72.|||Participants|||Number
1469705|NCT00708942|Secondary|Incidence of Patients With Adverse Events||3 months|All patients treated|||percentage of no of patients analyzed|||Number
1469706|NCT00708942|Secondary|Eradication of HPV|High risk HPV|6 months|Patients who were positive for high risk HPV at baseline|||percentage of no. of patients analyzed|||Number
1482067|NCT00609739|Secondary|Patients With Regimen-Related Toxicity|Number of patients with adverse events related to treatment.|Up to 30 Days Post Study Treatment||||participants|||Number
1469709|NCT00708851|Secondary|The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions.|Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone.|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.|||participants|||Number
1469710|NCT00708851|Primary|The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions.|Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe).|12 weeks of treatment|Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05.|||percent improvement from baseline||Full Range|Mean
1469711|NCT00708734|Primary|Gait and Balance Measures|Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.|5 months|The purpose of this pilot study was to evaluate the feasibilty of a structured, group exercise program in this population. Only 3 of 10 participants completed the study, due to high attrition, the project was considered unfeasible and data was not analysis.||||||
1469712|NCT00708721|Secondary|Number of Participants With Adverse Events|NCI CTCAE version 3.0 will be used to assess adverse events. The number of participants experiencing adverse events and the number of adverse events per patient will be documented through the course of study.|To 30 days after end of treatment or until full resolution.|All participants experienced at least 1 adverse event (100% of the patient population; 11/11 participants)|||participants experiencing adverse events|||Number
1469713|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on miRNA and mRNA Expression Patterns in Patients With MDS|Assessment of potential change in miRNA and mRNA genetic expression patterns in patients following administration of low dose daily clofarabine.|through end of treatment|Data were not collected and the outcome measure was not analyzed||||||
1469714|NCT00708721|Secondary|The Effect of Low Dose Daily Oral Clofarabine on Global Methylation in Patients With MDS.|Potential genomic changes following low dose daily oral clofarabine administration will be assessed.|through end of treatment|Data were not collected and the outcome measure was not analyzed||||||
1469715|NCT00708721|Secondary|Response of MDS Patients Treated With Low Dose Daily Oral Clofarabine.|Stable disease is defined as failure to achieve at least PR, but no evidence of progression for > 8 weeks.|approximately 4 years|Of 11 patients, 9 were evaluable for response. Two patients had stable disease responses.|||Participants|||Count of Participants
1469716|NCT00708721|Secondary|Time to Progression to Acute Myeloid Leukemia (AML)|Longest documented duration of time until progression to AML.|approximately 4 years|Cycles are 28 days long. Analysis assessed the longest number of cycles completed on study until progression to AML.|||cycles|||Number
1469717|NCT00708721|Primary|The Overall Response Rate in Response to Low Dose Daily Oral Clofarabine in Patients With High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (Dysplastic Type).|Response rate was measured as complete, partial and hematologic improvement by modified IWG criteria. For complete remission the following must be present for four weeks in a bone marrow aspirate and biopsy: <5% myeloblasts, normal maturation of all cell lines, persisted dysplasia. Peripheral blood counts need to be hemoglobin >11 g/dL, neutrophils >1000/mm3, platelets>100000/mm3, blasts 0%. Partial remission requires all criteria for complete remission except blasts decreased by >50% over pretreatment. Stable disease is defined as failure to achieve at least partial remission, but no evidence of progression for > 8 weeks. Failure is defined as death during tre3atment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment.|4 weeks|Two patients were not eligible for analysis.|||participants who experienced a response|||Number
1469718|NCT00708721|Primary|Number of Participants Who Experienced a Dose-Limiting Toxicity|Dose-limiting toxicity was defined as any nonhematologic toxicity grade 3 or greater except for alopecia or nausea (which may be of grade 4 severity), or any grade 4 hematologic toxicity lasting more than 28 days after the last day of therapy.|28 days after the first admistration of oral clofarabine|9 out of 11 participants were evaluable for this outcome.|||participants who experienced a DLT|||Number
1469719|NCT00708708|Secondary|Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with AEs included participants affected with both SAEs and non-SAEs.|Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24)|Safety analysis set included all participants with available post-baseline safety data.|||participants|||Number
1469720|NCT00708708|Secondary|Criteria for Treatment Resumption|Criteria for resumption of therapy for another cycle by the physician were specified after the 5 drug-free intervals as 1) new disease activity (NDA), 2) prevention of deterioration (POD), 3) other reasons (included reasons like end of adverse event, frequent occurrence of adverse event or pre-specified therapy scheme), 4) new disease activity and prevention of deterioration, 5) new disease activity and other reason, 6) prevention of deterioration and other reason, and 7) new disease activity, prevention of deterioration, and other reasons.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
1470699|NCT00703391|Primary|Reticulocytes|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||relative particle count (%)||Standard Deviation|Mean
1469721|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Recommendation of Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “Would you recommend therapy with Enbrel to other patients with plaque-psoriasis?” Participants responded as yes or no to the question. Results are reported for participant’s likeliness to recommend therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points. Results are not reported for before Cycle 4, 5, 6, and after Cycle 5 as no participant was evaluable at these time points.|||participants|||Number
1469722|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Preference to Continuous Therapy|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked, “If possible, would you prefer a continuous therapy without drug-free interval?” Participants responded as yes or no to the question. Results are reported for participant’s preference towards continuous therapy.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
1469723|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Comfort in Everyday Life|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval means more comfort in my everyday life.” Results are reported for participant’s perception of comfort of life during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469724|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reminder of Disease|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “During drug-free interval I will not be reminded permanently of my disease.” Results are reported for participant’s perception of reminder of disease during the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469725|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before and after the drug-free interval participants were asked to respond on a scale of 1 (no agreement) to 5 (complete agreement) to the statement, “A drug-free interval reduces the risk for adverse drug reactions.” Results are reported for participant’s perception of risk of adverse drug reactions.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469726|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How much were you satisfied with the condition of your skin during the first half of the drug-free interval?” and “How much were you satisfied with the condition of your skin during the second half of the drug-free interval?” Participants responded on a scale of 1 (very dissatisfied) to 5 (very satisfied). Results are reported for participant’s satisfaction with their skin condition during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469727|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Disease Activity|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the activity of your disease during the first half of the drug-free interval?” and “How would you assess the activity of your disease during the second half of the drug-free interval?” Participants responded on a scale of 1 (no activity) to 5 (strongest possible activity). Results are reported for participant’s perception of disease activity during the first half and second half of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469785|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin at Week 24|Hematology parameter included mean corpuscle hemoglobin. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||picograms||Standard Deviation|Mean
1469728|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “To what extend are you relieved by the fact that there is an effective therapy after the drug-free interval?” After the drug-free interval participants were asked, “To what extend were you relieved by the fact that there is an effective therapy after the drug-free interval?” Participants responded on a scale of 1 (not much relieved) to 5 (very much relieved). Results are reported for participant’s perception of effective therapy after drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469729|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Relapse of Symptoms|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How much are you concerned about a relapse of symptoms?” After the drug-free interval participants were asked, “Were you concerned about a relapse of symptoms during the drug-free interval?” Participants responded on a scale of 1 (not concerned) to 5 (very much concerned). Results are reported for participant’s perception of relapse of symptoms.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469730|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Duration|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “How would you assess the length of the current drug-free interval?” Participants responded on a scale of 1 (too long) to 5 (too short). Results are reported for participant’s perception of the duration of drug-free interval.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469731|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “Do you basically like the idea of a drug-free interval?” After the drug-free interval participants were asked, “How did you like the current drug-free interval?” Participants responded on a scale of 1 (not at all) to 5 (very good). Results are reported for participant’s liking of the drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469732|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Reason for Returning to Practice|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). After the drug-free interval participants were asked, “Why did you return to the practice today?” Responses included unscheduled visit due to new occurrence of disease, scheduled visit or other reasons (included reasons like treatment of adverse event, get a prescription or examination after external treatment). Results are reported for reasons for returning to the practice.|Before Cycle 2, 3, 4, 5, 6|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||participants|||Number
1469733|NCT00708708|Secondary|Participant Perception of Drug-Free Interval: Length of Drug-Free Interval|A questionnaire was filled in by participants to evaluate their perception of drug-free interval before the start of every drug-free interval (after Cycle 1, 2, 3, 4, 5) and after every drug-free interval (before Cycle 2, 3, 4, 5, 6). Before the drug-free interval participants were asked, “How long do you expect the drug-free interval to last for?” After the drug-free interval participants were asked, “How long did the drug-free interval last?” Results are reported for participant’s perception of the length of drug-free interval.|Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5|Efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure; 'n’ signifies those participants who were evaluable for this measure at the specified time points.|||months||Standard Deviation|Mean
1469734|NCT00708708|Secondary|Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)|"Effect of drug free interval on EQ-5D was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here n’=number of participants evaluable at the specified time points for the given cycles.|||units on a scale||Standard Deviation|Mean
1470490|NCT00705367|Primary|Short-term Period: Mean Respirations Rate|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||Respirations per minute||Standard Deviation|Mean
1469735|NCT00708708|Secondary|Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score|"Effect of drug free interval on DLQI was determined by comparing the scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst)."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >= 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ’n’=number of participants evaluable at the specified time points for the given cycles.|||units on a scale||Standard Deviation|Mean
1469736|NCT00708708|Secondary|Effect of Drug-Free Interval on Patient’s Global Assessment of Disease Activity (PatGA)|"Effect of drug-free interval on PatGA was determined by comparing the PatGA scores of the sub group Participants Without Drug-Free Interval to that of the sub group Participants With Drug-Free Interval. PatGA: participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity."|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
1469737|NCT00708708|Secondary|Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications|Annual costs for participants for treatment with etanercept due to out of pocket payments (included payments which were not reimbursed by the health insurance funds) and concomitant medications was reported per month for costs prior to study and per year for each year in the study up to 5 years. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Prior to study, Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.|||Euros||Standard Deviation|Mean
1469738|NCT00708708|Secondary|Average Cost of Treatment by Disease Severity|Average costs for treatment with etanercept up to 5 years was calculated in Euros. Disease severity was categorized as mild (0 to 10 PASI score), moderate (10.1 to 20 PASI score) and severe (20.1 to 72 PASI score) at each year. PASI: Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for the given disease severities.|||Euros||Standard Deviation|Mean
1469739|NCT00708708|Secondary|Annual Costs for Treatment With Etanercept|Costs for treatment with etanercept per year up to 5 years was calculated in Euros. 'By year' analysis was not possible for those participants for whom the data of 1 or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘n’= participants evaluable at the specified time points for this outcome measure.|||Euros||Standard Deviation|Mean
1469740|NCT00708708|Secondary|Number of Participants With at Least 1 Concomitant Medication|Number of participants taking any non-study medications which were administered during the period of etanercept treatment for the management of an adverse event or for the treatment of any other disease and not plaque psoriasis were reported.|Cycle 1 Week 0 up to Cycle 6 Week 24|Safety analysis set included all participants with available post-baseline safety data.|||participants|||Number
1469741|NCT00708708|Secondary|Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469742|NCT00708708|Secondary|Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)|EQ-5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999; higher score indicates a better health state.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469824|NCT00708435|Secondary|45-Day All-cause Mortality||Until Day 45|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||participants|||Number
1469743|NCT00708708|Secondary|Dermatology Life Quality Index (DLQI) Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469744|NCT00708708|Secondary|Patient’s Global Assessment of Disease Activity (PatGA)|Participants were asked to rate the severity of their disease activity on a 6-point scale, where 0 = no activity and 5 = severe or maximum activity.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set included all participants >=18 years of age, confirmed diagnosis of plaque psoriasis, had not received treatment with etanercept previously and had post baseline documentations. Here, ’n’=number of participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469745|NCT00708708|Secondary|Percentage of Time on Treatment Over Entire Period|Percentage of time on etanercept treatment over entire treatment period was calculated. It was calculated as 100% * ([Date of last application - Date of first application + 1] - Sum of duration of drug-free intervals [days])/(Date of last application - Date of first application + 1).|Cycle 1 up to Cycle 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of entire treatment period||Standard Deviation|Mean
1469746|NCT00708708|Secondary|Percentage of Time on Treatment in First Year|Percentage of time on etanercept treatment for first year was calculated. It was calculated as 100% * (365- sum of durations of drug-free intervals in the first year)/365. Analysis was not possible for participants with missing data of visit 1 (Week 0) of Cycle 1.|Year 1|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of first year||Standard Deviation|Mean
1469747|NCT00708708|Secondary|Cumulative Dose of Etanercept Per Year|Cumulative dose of etanercept per year was calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n' = participants evaluable at the specified time points for this outcome measure.|||mg||Standard Deviation|Mean
1469748|NCT00708708|Secondary|Number of Injections Per Year|Number of etanercept injections per year were calculated up to 5 years. 'By year' analysis was not possible for those participants for whom the data of one or more visits was missing.|Year 1, 2, 3, 4, 5|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable at the specified time points for this outcome measure.|||injections||Standard Deviation|Mean
1469749|NCT00708708|Secondary|Patient Global Assessment of Efficacy|Participant assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.|||participants|||Number
1469750|NCT00708708|Secondary|Physician Global Assessment of Efficacy|Physician assessed the effectiveness of etanercept treatment at the end (Week 24) of each cycle as very good, good, moderate, and insufficient.|Week 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n'= number of participants evaluable at the end of the given cycles for this outcome measure.|||participants|||Number
1469751|NCT00708708|Secondary|Static Physician Global Assessment (sPGA) of Disease Activity|Static physician global assessment (sPGA) of disease activity was assessed as 0 (no psoriasis) to 5 (severe disease) based on severity of induration, scaling, and erythema across all psoriatic lesions.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. 'n'= participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469752|NCT00708708|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant’s palm to proximal interphalangeal and thumb = 1% of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The results of this outcome measure was summarized separately for participants without drug-free interval, participants with drug-free interval and remaining participants, as per planned analysis.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points for each arm, respectively.|||percentage of BSA||Standard Deviation|Mean
1469851|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||hours||Full Range|Median
1469753|NCT00708708|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent (%) area of skin involved was estimated: 0= 0% to 6= 90–100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. PASI score at Week 0 of each cycle signifies the disease activity at the time of resumption of etanercept therapy.|Week 0, 12, 24 of Cycle 1 to 6|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here 'n' = participants evaluable for this measure at the specified time points.|||units on a scale||Standard Deviation|Mean
1469754|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 6|Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 5 Week 24 up to Cycle 6 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1469755|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 5|Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 4 Week 24 up to Cycle 5 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1469756|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 4|Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 3 Week 24 up to Cycle 4 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed) = participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1469757|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 3|Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 2 Week 24 up to Cycle 3 Week 0|Efficacy analysis set: all participants >=18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post-baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1469758|NCT00708708|Primary|Duration of Drug-Free Interval Prior to Treatment Cycle 2|Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.|Cycle 1 Week 24 up to Cycle 2 Week 0|Efficacy analysis set: all participants greater than or equal to (>=) 18 years of age, confirmed diagnosis of moderate or severe plaque psoriasis, who received etanercept monotherapy for the first time during the study and had post baseline documentations. Here ‘N’ (number of participants analyzed)= participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Mean
1469759|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1469760|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 3 of Infant Series (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1469761|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1470700|NCT00703391|Primary|Haemoglobin (Hb)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||g/L||Standard Deviation|Mean
1469762|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (2 Months of Age)|Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event.|||Percentage of participants|||Number
1469763|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after toddler dose (12 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1469764|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 3 (6 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1469765|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 2 of Infant Series (4 months of age)|Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1469766|NCT00708682|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)|Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category.|Within 4 days after dose 1 of Infant Series (2 months of age)|Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction.|||Percentage of participants|||Number
1469767|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series.|Toddler Dose (12 months of age)|Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose.|||mcg/mL||95% Confidence Interval|Geometric Mean
1469768|NCT00708682|Other Pre-specified|GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 3 of infant series (6 months of age)|Evaluable 3-Dose Infant Immunogenicity population|||mcg/mL||95% Confidence Interval|Geometric Mean
1469769|NCT00708682|Other Pre-specified|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series|Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.|Dose 2 of infant series (4 months of age)|Evaluable 2-Dose Infant Immunogenicity population|||mcg/mL||95% Confidence Interval|Geometric Mean
1469770|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the toddler dose (13 months of age)|Evaluable Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1469771|NCT00708682|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after dose 2 of the infant series (5 months of age)|Evaluable 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1469772|NCT00708682|Primary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (95% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series (7 months of age)|Evaluable 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
1469773|NCT00708643|Secondary|Corneal Staining|A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.||||units on a scale||Standard Error|Least Squares Mean
1469774|NCT00708643|Secondary|Tarsal Hyperemia|Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1469775|NCT00708643|Secondary|Tarsal Roughness|Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1469776|NCT00708643|Primary|Upper Lid Margin Staining|Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks.|The analysis includes all subjects that completed the study.|||units on a scale.||Standard Error|Least Squares Mean
1469777|NCT00708643|Primary|Lens Comfort|"Rating of lens comfort by rating agreement to the following statement:~The lenses I am wearing are comfortable.~Rating using the following scale:~1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames."|At 3,7,10,13,17,21,24, and 27 days|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1469778|NCT00708643|Primary|Limbal Hyperemia|Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.|At 2 weeks and 4 weeks|The analysis includes all subjects that completed the study.|||units on a scale||Standard Error|Least Squares Mean
1469779|NCT00708552|Secondary|Exposure Estimates for Donepezil Average Concentration at Steady State (Cavgss)|Blood sample for pharmacokinetic analysis, were obtained within 24 hours of last dose. A total of five pharmacokinetic samples per participants were taken at Weeks 4, 8,12,18 and Week 24. The Donepezil exposures at steady state Cavgss for each participant were estimated via nonlinear mixed effect analysis. Data has been presented in a consolidated format for SB-742457 exposures at steady state Cavgss.|Weeks 4, 8,12,18 and Week 24|Pharmacokinetic concentration population. Only those participants with data available at the time of analysis were included.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1469780|NCT00708552|Secondary|Exposure Estimates for SB-742457 Minimum Concentration at Steady State (Cmin-ss)|Blood sample for pharmacokinetic analysis, were obtained within 24 hours of last dose. A total of five pharmacokinetic samples per participants were taken at Weeks 4, 8,12,18 and Week 24. The SB-742457 exposures at steady state Cmin-ss for each participant were estimated via nonlinear mixed effect analysis. Data has been presented in a consolidated format for SB-742457 exposures at steady state Cmin-ss.|One sample at Day 28±5, 56±5, 84±5, 126±5 and 168±5 post 24 hours of last dose|Pharmacokinetic concentration population. Only those participants with data available at the time of analysis were included.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
1469781|NCT00708552|Secondary|Exposure Estimates for SB-742457 Area Under Curve Over the Dosing Interval at Steady State (AUCτss)|A total of five pharmacokinetic samples per participant were collected for the purpose of assessing plasma concentrations of SB-742457 and donepezil. At each visit (Day 28±5, 56±5, 84±5, 126±5 and 168±5) one sample was collected post 24 hours of last dose.|One sample at Day 28±5, 56±5, 84±5, 126±5 and 168±5 post 24 hours of last dose|Pharmacokinetic concentration population comprised of all participants for whom a pharmacokinetic sample was obtained and analyzed. Only those participants with data available at the time of analysis were included.|||nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
1469782|NCT00708552|Secondary|Number of Participants With Electrocardiogram (ECG) Findings as Assessed by Investigator and Central Cardiologist|The clinical interpretation of the ECG by the investigator was recorded as Normal, Abnormal but not clinically significant (ANCS) and Abnormal clinically significant (ACS). ECG interpretation by the central cardiologist included the most extreme result of the available ECGs where the central cardiologist’s interpretation of the ECG was recorded as Normal, Unable to Evaluate and Abnormal. Data has been presented for number of participants with most severe on-treatment abnormal ECG findings.|Upto Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1469783|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Red Blood Cell Count at Week 24|Hematology parameter included red blood cell count. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||trillion cells per liter||Standard Deviation|Mean
1469784|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Mean Corpuscle Volume and Mean Platelet Volume at Week 24|Hematology parameter included mean corpuscle volume and mean platelet volume. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||femtoliters||Standard Deviation|Mean
1470701|NCT00703391|Primary|Creatinine|Creatinine level greater than the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1469786|NCT00708552|Secondary|Change From Baseline in Hematology Parameters Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Week 24|Hematology parameter included hemoglobin and mean corpuscle hemoglobin concentration. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
1469787|NCT00708552|Secondary|Change From Baseline in Hematology Parameter Hematocrit|Hematology parameter included hematocrit. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Ratio||Standard Deviation|Mean
1469788|NCT00708552|Secondary|Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, White Blood Cell Count at Week 24|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils, white blood cell count. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||giga cells per liter||Standard Deviation|Mean
1469789|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Creatinine, Direct Bilirubin and Total Bilirubin at Week 24|Clinical chemistry parameters included creatinine, direct bilirubin and total bilirubin. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||umol/L||Standard Deviation|Mean
1469790|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Calcium, CO2 Content/Bicarbonate, Chloride, Glucose, HDL Cholesterol, LDL Cholesterol, Magnesium, Phosphorus, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen at Week 24|Clinical chemistry parameters included calcium, CO2 content/bicarbonate, chloride, glucose, HDL cholesterol, LDL cholesterol, magnesium, phosphorus, potassium, sodium, triglycerides, urea/blood urea nitrogen. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
1469791|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameter Blood Urea Nitrogen /Creatinine Ratio at Week 24|Clinical chemistry parameter included blood urea nitrogen /creatinine ratio. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Ratio||Standard Deviation|Mean
1469792|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein at Week 24|Clinical chemistry parameters included albumin and total protein. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||grams per liter||Standard Deviation|Mean
1469793|NCT00708552|Secondary|Change From Baseline in Clinical Chemistry Parameters Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Week 24|Clinical chemistry parameters included alanine amino transferase, alkaline phosphatase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 24.|Baseline (Week 0) and Week 24|Safety population. Only those participants available at the specified time point were analyzed.|||IU/L||Standard Deviation|Mean
1469794|NCT00708552|Secondary|Number of Participants With Chemistry Data of PCC ATOT|Clinical chemistry parameters included alanine amino transferase international units per liter (IU/L) RR [0-48], alkaline phosphatase IU/L (20-125), aspartate amino transferase international units per liter (0-55), blood urea nitrogen/creatinine ratio (24-101), calcium millimoles per liter (mmol/L) [2.12-2.56], carbon dioxide content/bicarbonate mmol/L (20-32), cholesterol mmol/L (0.00-5.15), creatine kinase IU/L (males 0-235 and females 0-190), creatinine micromoles per liter (umol/L) [44-124], direct bilirubin umol/L (0-6), gamma glutamyl transferase IU/L (males 0-65 and females 0-45), glucose mmol/L (3.9-6.9), low density lipoprotein cholesterol mmol/L (0.00-3.35), lactate dehydrogenase IU/L (0-270), potassium mmol/L (3.5-5.3), sodium mmol/L (135-146), total bilirubin umol/L (0-22), triglycerides mmol/L (0.00-2.24), urea/blood urea nitrogen mmol/L (2.5-10.5). Data has been presented in a consolidated format for clinical chemistry parameters high and low from the RR of PCC ATOT.|Upto Week 24|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
1469795|NCT00708552|Secondary|Number of Participants With Hematology Data of PCC ATOT|Hematology parameters included hematocrit ratio (reference range males 0.410-0.500, females 0.350-0.460 [18-64 years] and males 0.360-0.490, females 0.330-0.460 [65+ years]), hemoglobin grams per liter (13.8-17.2), lymphocytes giga per liter (0.85-4.10), monocytes giga per liter (0.20-1.10), platelet count giga per liter (130-400), segmented neutrophils giga per liter (1.80-8.00), total neutrophils (1.80-8.00). Data has been presented in a consolidated format for hematology parameters high and low from the reference range of PCC ATOT.|Upto Week 24|Safety population. Only those participants available at the specified time point were analyzed.|||Participants|||Number
1469825|NCT00708435|Secondary|Use of Other Blood Products and Hemostatic Agents|Other blood products and hemostatic agents containing coagulation factors (such as whole blood, plasma, albumin, platelets) not including PRBCs.|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||Units of blood products||Standard Deviation|Mean
1469796|NCT00708552|Secondary|Number of Participants With Vital Signs Data of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT)|Vital sign measurements included systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Heart Rate (HR), Body weight (BW). SBP and DBP and HR were measured once after the participant sat quietly for at least 5 minutes and in addition, upon standing to assess participants for postural hypotension. DBP was measured at the disappearance of Korotkoff sounds (Phase V). The plethysmographic method (preferably with a column sphygmomanometer where available) was used to measure blood pressure throughout the study. Body weight was measured, without shoes and wearing light clothing. The PCC range were as follows: SBP (Reference Range [RR] <90-140> Increase from Baseline [IFB]>=40 and decrease from baseline [DFB] >=30), DBP (RR < 50-90> IFB>=30 and DFB >=20), HR (RR <50-100> IFB >=30 and DFB >=30, BW (IFB >= 7% and DFB >=7%).|Upto Week 24|Safety population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Number
1469797|NCT00708552|Secondary|Number of Participants With Any Adverse Event (Serious and Non-serious) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Number of participants with any adverse event (serious and non-serious) and SAEs were reported.|Upto Week 24|Safety population.|||Participants|||Number
1469798|NCT00708552|Secondary|Change From Baseline in ADCS-ADL-Basic Score; ADCS-ADL: Instrumental Score and ADCS-ADL: Total Independence Score at Weeks 12 and 24|Basic score was calculated as the sum of questions 1-6b and ranges from 0-22 (activities included are: eating, walking, using the toilet, bathing, grooming and dressing) and Instrumental score, sum of questions 7-23, ranges from 0-56 (activities included are: using the telephone, watching television, conversations, clearing dishes, personal belongings, making drinks, making snacks, taking rubbish out, getting out and about, shopping, keeping appointments, being left alone, current events, reading, writing, pastimes/hobbies, household chores). Total independence score is calculated by re-scoring the individual questions for each activity. The total independence score therefore ranges between 0 to 23, where 23 indicates that a participant is independent (based on these 23 ADL). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 12 and 24.|Baseline (Week 0) and Weeks 12 and 24|ITT population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469799|NCT00708552|Secondary|Change From Baseline in MMSE Total Score at Week 24|The MMSE is used to test for cognitive dysfunction. The scale is completed by a trained and experienced neurologist/psychiatrist/neuropsychologist based on the performance of the participants, and takes approximately 5 to 10 minutes to administer. It consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing, drawing across 5 sections (orientation, registration, attention-calculation, recall, and language). Scoring was done by circling 0 if the response was incorrect, or 1 if the response was correct. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better cognitive function. The total MMSE score was a sum of all item scores. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469800|NCT00708552|Secondary|Change From Baseline in Cornell Scale for Depression in Dementia (CSDD) Total Score at Week 24|The CSDD is used to assess signs and symptoms of major depression in demented participants. The CSDD scale contains 19 items on mood-related signs of depression, behavioral disturbance, physical signs of depression, cyclic functions and ideational disturbances, where each item is rated for severity on a scale of 0-2 (0=absent, 1=mild/intermittent, 2=severe). Scores above 10 (probable major depression),scores above 18 (definite major depression), scores below 6 (absence of significant depressive symptoms). The total score was calculated as a weighted average of the scores provided for the remaining 18 questions as follows: Imputed Total= Observed Total Score x 1+ Maximum Score of the missing value/ Sum of the Maximum Score of the non -missing values) and ranges from 0-38. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469801|NCT00708552|Secondary|Change From Baseline in Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) Total Score at Weeks 12 and 24|The ADCS-ADL measures functional impairment in terms of activities of daily living. The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions (i.e. those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, making judgments and decisions) about the participant. The questions range from basic to instrumental activities of daily living and take approximately 20 minutes to complete. The Total score ranges from 0-78 and a higher score signifies greater functional ability and lower scores indicating greater impairment. The total score is the sum of all items and sub-questions. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Weeks 12 and 24.|Baseline (Week 0) and Weeks 12 and 24|ITT population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469826|NCT00708435|Secondary|Transfusion of Red Blood Cells|Red blood cells were packed red blood cells (PRBCs).|From the start of infusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||Units of PRBCs||Standard Deviation|Mean
1469802|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 10-20.|Week 12|Intent-to-Treat (Baseline MMSE 10-20). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469803|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 16-26.|Week 12|Intent-to-Treat (Baseline MMSE 16-26). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469804|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 12|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE score 10-20. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|Intent-to-Treat (Baseline MMSE 10-20). Only those participants available at the specified time-points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469805|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 12|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for Participants with Baseline MMSE score 16-26. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|Intent-to-Treat (Baseline MMSE 16-26). Only those participants available at the specified time-points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469806|NCT00708552|Secondary|Change From Baseline in RBANS Total Score at Week 12|RBANS is an individually administered neurocognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). The scale is completed by a trained and experienced neurologist, psychiatrist or neuropsychologist, or another trained and experienced person. It is preferred that this individual is the same person who administers the ADAS-Cog, but he/she must be a separate individual from the person who completes the CIBIC+. The scale is based on the performance of the participant and takes approximately 25-30 minutes to administer. Raw total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where low score= (greater impairment) and high score=(better cognitive function). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469807|NCT00708552|Secondary|CIBIC+ Score at Week 12|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse).|Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469827|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After Randomization|The time taken from randomization to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
1482068|NCT00609739|Primary|Disease-free Survival|Number of patients who were free of disease and alive at 1 year.|1 year||||Participants|||Number
1469808|NCT00708552|Secondary|Change From Baseline in ADAS-Cog Total Score at Week 12|ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a five point scale. The ADAS-Cog total score is the sum of the calculated scores for Questions 1 (Word recall task), 2 (Naming objects and fingers), and 7 (Word recognition task) and the scores recorded on the CRF for Questions 3 to 6 (Commands, Constructional praxis, Ideational praxis, Orientation) and 8 to 11 (Remembering test instructions, Spoken language ability, Word finding difficulty in spontaneous speech, Comprehension). The total score ranges from 0-70 with higher scores indicating greater dysfunction while lower indicates better cognitive function. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 12.|Baseline (Week 0) and Week 12|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469809|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 10-20) on the CIBIC+ Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Higher scores indicate worst outcome. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with baseline MMSE 10-20. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 10-20). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469810|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline MMSE Scores 16-26) on the CIBIC+ Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse). Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 16-26. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 16-26). Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469811|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline [MMSE Scores 10-20) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 24|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 10-20. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 10-20) which comprised of participants who had a baseline MMSE score of 16-26. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469812|NCT00708552|Secondary|Effect of Baseline Severity (Including Subgroup Analyses Based on Baseline Mini Mental State Examination [MMSE] Scores 16-26) on the Change From Baseline in ADAS-Cog Total Score, the Change From Baseline in RBANS Total Score at Week 24|The MMSE was used to measure cognitive impairment. The MMSE consists of 11 tests namely orientation to time, orientation to place, registration, attention and calculation, recall, naming, repetition, comprehension, reading, writing and drawing corresponding to 5 domains orientation, memory, attention, and construction. All items were scored as 0 (incorrect response) or 1 (correct response). Total scores ranges from 0 to 30, with lower scores indicating greater cognitive impairment and higher scores indicating better function. Stratification by Baseline severity, using MMSE score at Baseline, with the strata being MMSE score of 10-15, 16-20 and 21-26. Two subgroups using MMSE score at Baseline were also examined, moderate 10-20 and mild 16-26. Data has been presented for participants with Baseline MMSE 16-26. Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|Intent-to-Treat (Baseline MMSE 16-26) which comprised of participants who had a baseline MMSE score of 16-26. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469828|NCT00708435|Secondary|Percentage of Participants With INR Correction at Various Times After the Start of Infusion|The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion.|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants|||Number
1469852|NCT00708214|Secondary|Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of letrozole in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1469813|NCT00708552|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score at Week 24|RBANS is an individually administered neurocognitive battery comprising 12 subtests across five domains (Attention, Language, Visuospatial/Constructional Abilities, and Immediate and Delayed memory). The scale is completed by a trained and experienced neurologist, psychiatrist or neuropsychologist, or another trained and experienced person. It is preferred that this individual is the same person who administers the ADAS-Cog, but he/she must be a separate individual from the person who completes the CIBIC+. The scale is based on the performance of the participant and takes approximately 25-30 minutes to administer. Raw total scores are calculated by adding up the scores for each of the 12 individual subtests and ranges between 0 and 311, where low score= (greater impairment) and high score=(better cognitive function). Baseline was defined as the value at Visit 3 (Week 0). Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469814|NCT00708552|Primary|Clinician’s Interview-Based Impression of Change – Plus (CIBIC+) Score at Week 24|The CIBIC+ is a rating scale derived from an interview with the participant and caregiver with an independent rater designed to measure several domains of participant function, such as mental/cognitive state, behavior, and functioning. The scores are rated on a scale of 1 to 7 as follows: 1 (marked improvement), 2 (moderately improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (moderately worse) and 7 (markedly worse).|Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469815|NCT00708552|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 24|ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a five point scale. The ADAS-Cog total score is the sum of the calculated scores for Questions 1 (Word recall task), 2 (Naming objects and fingers), and 7 (Word recognition task) and the scores recorded on the CRF for Questions 3 to 6 (Commands, Constructional praxis, Ideational praxis, Orientation) and 8 to 11 (Remembering test instructions, Spoken language ability, Word finding difficulty in spontaneous speech, Comprehension). The total score ranges from 0-70 with higher scores indicating greater dysfunction while lower indicates better cognitive function. Baseline was defined as the value at Week 0. Change from Baseline was obtained by subtracting the Baseline value from the post-randomization value at Week 24.|Baseline (Week 0) and Week 24|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
1469816|NCT00708526|Secondary|Return of Cognitive Function|average time in minutes from the time the surgeon finished closing the surgical incision at the end of surgery until the patients could correctly state their full name, the current year and their day, month and year of birth|up to 30 minutes|number of participants determined by protocol|||minutes||Standard Deviation|Mean
1469817|NCT00708526|Primary|Recovery From Anesthesia|average time in minutes from the time the surgeon finished closing the surgical incision until the time the investigator in the postoperative care unit determined that the patients meet the discharge criteria from the postoperative anesthesia care unit (their vital signs had been stable for at least 30 min, their pain scores were less than the tolerable pain scores, they could sit up without dizziness or nausea, and their Aldrete score was ≥8).|up to 2 hours||||minutes||Standard Deviation|Mean
1469818|NCT00708500|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.||At Follow-up Week 12 and at 72 weeks after randomization|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||participants|||Number
1469819|NCT00708500|Secondary|Number of Participants With Early Virologic Response.|Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.|At Week 2, 4, 8, or 12|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||participants|||Number
1469820|NCT00708500|Secondary|Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.|"SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment.~This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009."|At Follow-up Week 24|mITT = all randomized subjects who received at least one dose of boceprevir (experimental arms) or boceprevir placebo (control arm).|||Percentage of Participants|||Number
1469821|NCT00708500|Primary|Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.|SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.|At Follow-up Week 24|FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).|||Percentage of Participants|||Number
1469822|NCT00708461|Primary|Change in Body Mass Index (BMI)|Assessed in kilograms per meter squared.|Baseline to 24 months|Participants with complete data at baseline and two years, and those who were not pregnant at either time, were retained for analysis.|||kilograms per meter squared||Standard Error|Least Squares Mean
1469823|NCT00708435|Secondary|Overall Treatment-emergent Adverse Events (TEAEs)|Number of participants with TEAEs. Treatment-related AEs were defined as events whose relationship to study treatment was definitely related, probably related, or possibly related in the opinion of the investigator. AEs with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent SAEs. Deaths reported up to and including Day 45; one additional Beriplex death occurred after Day 45.|From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs.|The ITT-S population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'.|||participants|||Number
1470702|NCT00703391|Primary|Total Bilirubin|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||micromol/L||Standard Deviation|Mean
1469829|NCT00708435|Secondary|Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S|Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal.|From preinfusion until 24 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of normal||Standard Deviation|Mean
1469830|NCT00708435|Secondary|Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex|The incremental IVR [(IU/dL)/(IU/kg)] was calculated as follows: (IU/dL activity rise in plasma)/(IU/kg body weight infused) = [maximum increase in component plasma level within 3 hours compared to pre-infusion (IU/dL)]/{[exact dose of component in drug administered (IU)]/[body weight (kg)]}.|Before infusion and up to 3 h after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||(IU/dL)/(IU/kg body weight)||Standard Deviation|Mean
1469831|NCT00708435|Secondary|Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 3 and 6 hours after the start of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 3 and 6 hours after the start of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1469832|NCT00708435|Primary|Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)|A rapid decrease of the international normalized ratio (INR) was defined as an INR ≤ 1.3 at 30 minutes after the end of the infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy.|30 minutes after end of infusion|The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1469833|NCT00708435|Primary|Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed|Hemostatic efficacy was determined by a blinded independent board as excellent, good, or poor/none, based on prespecified definitions. Assessments of visible or non-visible musculoskeletal bleeding were made at 1 and 4 hours after the end of infusion. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where ‘effective’ was a hemostatic efficacy rating of “excellent” or “good,” and ‘non-effective’ was a hemostatic efficacy rating of “poor/none”.|At 1 and 4 hours after the end of infusion|The Intention-to-Treat Efficacy (ITT-E) population included all randomized participants who had received any study product, presented with acute major bleeding, and had an international normalized ratio (INR) > 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.|||percentage of participants||95% Confidence Interval|Number
1469834|NCT00708422|Secondary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score|The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.|||Units on a scale||Standard Deviation|Mean
1469835|NCT00708422|Primary|Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)|Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.|12 weeks (Day 84)|Intent-to-treat: All patients who received test article and completed the trial.|||seconds||Standard Deviation|Mean
1469836|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 4 hours post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1469837|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 2 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1469847|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 3|Visit 3 Log10 PC20 after receiving 2 weeks of Advair|Visit 3:12 hours after the last dose of Advair|All participants who had a methacholine challenge at Visit 3. All participants had received Advair for 2 weeks.|||log10 mg/mL||Standard Deviation|Mean
1469838|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 1 hour post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1469839|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 30 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1469840|NCT00708305|Secondary|Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments|Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.|Plaque samples were collected at baseline, 15 minutes post single application of study treatment|"PP population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||μg*F/g||Full Range|Median
1469841|NCT00708305|Secondary|Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||ln(μg*F*minutes/cm^2)||Standard Error|Log Mean
1469842|NCT00708305|Primary|Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours|To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.|Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment|"Per-Protocol (PP) population: All participants who had at least one post-baseline efficacy assessment but did not have any major protocol deviations. Due to drop outs, there were differences in the n per treatment group. Missing data was not imputed."|||ln(μg*F*minutes/cm^2)||Standard Error|Least Squares Mean
1469843|NCT00708227|Secondary|Bronchodilator Response Following Methacholine Challenge at Visit 4|The area under the curve (AUC) bronchodilator response after Visit 4 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had discontinued Advair for 36 hours.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 36 hours after the last dose of Advair|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Advair for 2 weeks at Visit 3.|||Liters*min||Standard Deviation|Mean
1469844|NCT00708227|Secondary|Bronchodilator Response Following Methacholine Challenge at Visit 3|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Advair for 2 weeks at Visit 3.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Advair|The area under the curve (AUC) bronchodilator response after Visit 3 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached. Participants had received Advair for 2 weeks at Visit 3.|||Liters*min||Standard Deviation|Mean
1469845|NCT00708227|Secondary|Bronchodilator Response to Methacholine (PC20) After Visit 2|The area under the curve (AUC) bronchodilator response after Visit 2 methacholine challenge. 2.5mg of albuterol was administered at the time of maximal brochoconstriction once the methacholine PC20 was reached and the change in FEV1 was measured over the next 60 minutes post albuterol administration (bronchodilator response). FEV1 was measured at the following times: 0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes. Participants had received Flovent for 2 weeks at Visit 2.|0 (immediately upon completion of nebulization) and at 1, 3, 5, 10, 15, 20, 30, 45, and 60 minutes after nebulization was complete which occurred 12 hours after the last dose of Flovent.|All participants who had received Flovent for 2 weeks at Visit 2.|||Liters*min||Standard Deviation|Mean
1469846|NCT00708227|Primary|Log10 PC20 to Methacholine After Visit 4|Visit 4 log10 PC20 to Methacholine after stopping Advair|36 hours after the last dose of Advair|All participants who had a methacholine challenge at Visit 4. All participants had discontinued Advair for 36 hours.|||log10 mg/mL||Standard Deviation|Mean
1469853|NCT00708214|Secondary|Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUC0-tau,ss represents the area under the concentration curve of letrozole in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Analysis of all treatment arms combined, as Letrozole dose was the same in all arms.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1469854|NCT00708214|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)|tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||hours||Full Range|Median
1469855|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)|Cpre,ss,85 represents the pre-dose concentration of afatinib in plasma at steady state on day 85.|Day 85|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1469856|NCT00708214|Secondary|Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)|Cpre,ss,57 represents the pre-dose concentration of afatinib in plasma at steady state on day 57.|Day 57|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1469857|NCT00708214|Secondary|Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)|Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1469858|NCT00708214|Secondary|Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)|AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau at steady state.|0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing|Data were particularly sparse for the 50 mg starting dose group and were not summarised.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
1469859|NCT00708214|Secondary|Overall Survival (OS)|OS was defined as the time from first treatment to death.|Baseline till progression, death or data cut-off|TS. Estimation of median time to death was not feasible, due to the small number of patients who died during the trial.|||days||95% Confidence Interval|Median
1469860|NCT00708214|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. Progression was assessed according to RECIST criteria.|Baseline till progression, death or data cut-off (04 Jan 2010)|TS|||days||95% Confidence Interval|Median
1469861|NCT00708214|Secondary|Duration of Confirmed OR|Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).|First occurence or OR till progression or death|TS. Median duration of RECIST tumour response was not calculable as there was no OR observed.|||days||95% Confidence Interval|Median
1469862|NCT00708214|Secondary|Time to RECIST Tumour Reponse|The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.|Baseline till progression|TS. Median time to RECIST tumour response was not calculable as there was no OR observed.|||days||95% Confidence Interval|Median
1469863|NCT00708214|Secondary|Number of Participants With Clinical Benefit (CB)|CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.|16 weeks and 24 weeks|TS|||Participants|||Number
1469864|NCT00708214|Secondary|Number of Participants With Confirmed Objective Response (OR)|OR was defined as complete response (CR) or partial response (PR) and was assessed according to RECIST criteria regardless of treatment status.|Baseline till progression|TS|||Participants|||Number
1469865|NCT00708214|Primary|Percentage of Progression Free Participants After 16 Weeks of Treatment|Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.|16 weeks|Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.|||Percentage of participants||95% Confidence Interval|Number
1469866|NCT00708201|Secondary|Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events|CV events of interest included congestive heart failure, CV death, cerebrovascular accident, myocardial infarction, serious arrhythmia, and unstable angina. CV events were adjudicated by a blinded external committee.|Baseline to 30 days post discharge|All participants who received at least 1 dose of study medication.|||percentage of participants|||Number
1469867|NCT00708201|Secondary|Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points|DOW responders were defined as those participants who met all the following criteria: achieved DOW by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. PSD were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.|||percentage of participants|||Number
1469868|NCT00708201|Secondary|Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points|Time to achieve recovery of GI function was measured by a composite endpoint of time to first BM and time to tolerate first solid food (solids). This endpoint was referred to as GI2, and GI2 was calculated as follows: GI2 = max (solids, BM). GI2 responders were defined as those participants who met all the following criteria: achieved GI2 by the cutoff point, did not have hospital stay prolonged because of POI, and did not have readmission for POI within 7 days of actual hospital discharge. Postsurgery Days (PSD) were measured in 24 hour increments after surgery.|Day of surgery (Day 0) through PSD 3, PSD 4, PSD 5, PSD 6, and PSD 7|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data.|||percentage of participants|||Number
1469869|NCT00708201|Secondary|Percentage of Participants With Postoperative Morbidity (POM)|POM was defined as the need for postoperative nasogastric (NG) tube insertion, hospital stay prolonged because of postoperative ileus (POI) (as determined by the investigator), or readmission (readmiss) to the hospital (hosp) for POI within 7 days (d) after discharge.|During hospitalization or within 7 days after discharge|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable POM data.|||percentage of participants|||Number
1469870|NCT00708201|Secondary|Percentage of Participants Considered Postoperative LOS Responders|A participant was considered a postoperative LOS responder if the postoperative LOS was less than or equal to 7 days. The postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery). Participants with missing data were considered nonresponders.|Day of surgery (Day 0) up to 7 days after surgery|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.|||percentage of participants|||Number
1469871|NCT00708201|Secondary|Postoperative Length of Stay (LOS)|The postoperative LOS was determined by the difference between the date of hospital DOW and the date of surgery; that is, the postoperative LOS for a participant was calculated as follows: (date of DOW) - (date of surgery).|Day of surgery (Day 0) to the day of hospital DOW|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable postoperative LOS data.|||Days||Standard Deviation|Mean
1469872|NCT00708201|Secondary|Mean Time to Discharge Order Written (DOW) Using KM Estimates|"The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to DOW data. 36 participants in the Placebo group and 15 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
1469873|NCT00708201|Secondary|Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model|"The endpoint of “time to ready for discharge” was based solely on the recovery of GI function as determined by the surgeon. The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|Day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable ready to discharge data. 21 participants in the Placebo group and 12 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
1469874|NCT00708201|Primary|Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model|"Time to achieve recovery of gastrointestinal (GI) function as measured by a composite endpoint of both upper GI recovery (toleration of solid food) and lower GI recovery (first bowel movement [BM]) using KM Estimates and Cox PH Model. This endpoint was referred to as GI2. GI2 was calculated as GI2 = maximum (max) (solids, BM). The KM estimate reported below is biased because of the censoring of the last observation.~Censoring Rules for Study Participants who:~Completed: the censored time for the event was determined as: censored time = minimum [maximum (time of/to last GI assessment, time of/to hospital discharge order written), study duration].~Discontinued: censored time = maximum (time of/to last GI assessment, time of/to discontinuation)"|From day of surgery (Day 0) up to 10 days in hospital|All participants who received at least 1 dose of study medication, who had at least 1 postdose GI assessment, who had the protocol-specified surgery, and had evaluable time to achieve G12 data. 39 participants in the Placebo group and 17 participants in the Alvimopan group were censored.|||Hours||Standard Error|Mean
1469875|NCT00708175|Other Pre-specified|Number of Participants With Fracture|Number of participants with confirmed (through an adjudication process) fractures during the study. Circumstances surrounding the fracture, available X-ray and other diagnostic results and healing status were collected for the adjudication process.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||participants|||Number
1469876|NCT00708175|Other Pre-specified|Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM)|Participants were considered to have converted to T2DM if there were ≥2 consecutive post-Baseline FPG measurements ≥126 mg/dL. Participants meeting criteria were tabulated and summarized by Study Period (Treatment and Follow-up). Conversion to T2DM during Treatment Period occurred if either both of the consecutive post-Baseline high FPG values, or the first of the 2 consecutive high values occurred on or before the first day off study drug. Conversion to T2DM occurred during the Follow-up Period if both consecutive high values occurred after at least 1 day after the Treatment Period.|Up to 18 months.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||participants|||Number
1469877|NCT00708175|Other Pre-specified|Change in Fasting Plasma Glucose (FPG)|The change between the fasting plasma glucose value collected at each time frame indicated.|Baseline and Month 12; Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set).|||mg/dL||Standard Error|Least Squares Mean
1469878|NCT00708175|Secondary|Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA|The change in bone mineral density in the total proximal femur at month 18 relative to month 12. DXA is a means of measuring BMD through x-ray.|Month 12 and Month 18.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data.|||percent||Standard Error|Least Squares Mean
1469966|NCT00708032|Primary|Papillary Conjunctivitis|Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.|12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1469879|NCT00708175|Primary|Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)|The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 12.|All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data. If a valid pre-treatment scan was not available, the earliest (within 30 days) post-dosing scan was used as Baseline. There was one such participant for this endpoint.|||percent||Standard Error|Least Squares Mean
1469880|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 96|The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.|||cells/mm^3||Standard Deviation|Mean
1469881|NCT00708162|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.|||cells/mm^3||Standard Deviation|Mean
1469882|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 96|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.|Baseline to Week 96|Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1469883|NCT00708162|Secondary|Change From Baseline in HIV-1 RNA at Week 48|The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.|Baseline to Week 48|Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.|||log10 copies/mL||Standard Deviation|Mean
1469884|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1469885|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1469886|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1469887|NCT00708162|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1469888|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1469889|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1469890|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 96|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1469891|NCT00708162|Secondary|Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48|The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.|Baseline to Week 48|ITT Analysis Set|||percentage of participants||95% Confidence Interval|Number
1469892|NCT00708162|Secondary|Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1469893|NCT00708162|Secondary|Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)|Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1469894|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1469895|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1469896|NCT00708162|Secondary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 96|ITT Analysis Set|||percentage of participants|||Number
1469897|NCT00708162|Primary|Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.|Week 48|ITT Analysis Set|||percentage of participants|||Number
1469898|NCT00708123|Secondary|Adjusted Mean Change From Baseline in Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug F/cm2. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|"ITT population: All randomized participants who had a least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."|||µg*F/cm^2||Standard Error|Least Squares Mean
1469899|NCT00708123|Secondary|Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs, there were differences in the n per treatment group."|||%SMHR||Standard Error|Least Squares Mean
1469900|NCT00708123|Primary|Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)|%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.|Baseline to 14 days|"Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the n per treatment group."|||%SMHR||Standard Error|Least Squares Mean
1469901|NCT00708110|Secondary|Number of Participants With the Emergence of Drug Resistance Mutations|The number of participants with the emergence (from Baseline) of drug resistance mutations at Day 11 was measured.|Baseline and Day 11|ITT(E) Population|||participants|||Number
1469902|NCT00708110|Secondary|Median Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count at Day 11|Median change from Baseline in CD4+ cell count was calculated as the Day 11 value minus the Baseline value.|Baseline and Day 11|Per-Protocol Population: all participants included in the ITT(E) Population, excluding those who had at least one major protocol deviation|||Cells per cubic millimeter (cells/mm^3)||Full Range|Median
1469903|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population|||Log10 copies/mL||Standard Deviation|Mean
1469904|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA Levels During the Follow-up Period (Days 11 to 21)|Change from Baseline in Plasma HIV-1 RNA levels was calculated as the value during the Follow-up period minus the Basline value.|Baseline and Follow-up period (Days 11 to 21)|ITT(E) Population|||Log10 copies/mL||Full Range|Median
1469905|NCT00708110|Primary|Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Abnormalities|Clinical laboratory toxicities were graded according to the National Institutes of Allergy and Infectious Diseases (NIAID), Division of Acquired Immunodeficiency Syndrome (DAIDS). Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented only for Grade 3 and Grade 4 laboratory abnormalities. Clinical laboratory abnormalities included: increased glucose, lipase, decreased platelets, and triglycerides.|Screening; Days 1, 3, 7, and 10; and Follow-up (up to Study Day 21)|Safety Population|||participants|||Number
1469906|NCT00708110|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A 12-lead electrocardiogram (ECG) was performed by qualified personnel at the site after the participant had rested for at least 5 minutes in a semi-recumbent or supine position. If a QTc measurement of >=500 milliseconds (msec) was noted on a scheduled or unscheduled ECG, two additional ECGs were to be obtained within 5 minutes to confirm the abnormality. The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) ECG findings are presented here. The site determined if an ECG finding is significant or not. ECGs were obtained at Screening, Day 1 (pre-dose [twice] and then 1.0, 1.5, and 2.0 hours [hrs] post dose), Day 4 (pre-dose), Day 7 (pre-dose), Day 10 (pre-dose and then 1.0, 1.5, and 2.0 hrs post dose), Day 11 (prior to the 24 hr PK sample [pre lab]), and Follow-up.|Screening; Days 1, 7, 10, 11; and Follow-up (up to Study Day 21)|Safety Population. Only those participants who were available at the indicated time points were analyzed.|||participants|||Number
1469907|NCT00708110|Primary|Change From Baseline in Mean Heart Rate at Days 1, 4, 7, and 10|Heart rate is the measure of heart beats per minute (bpm). Change in the mean heart rate from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population|||beats per minute||Standard Deviation|Mean
1469967|NCT00708032|Secondary|Subjective Overall Vision After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1469908|NCT00708110|Primary|Change From Baseline in Mean Blood Pressure at Days 1, 4, 7, and 10|Blood pressure measurement included systolic blood pressure (SBP) and diastolic BP (DBP). Change in the mean blood pressure from Baseline was calculated as the post-Baseline value minus the Baseline value. Data are presented for change from Baseline at Day 1 (2 hours post dose [hrs]), Day 4 (1 hr pre-dose), Day 7 (1 hr pre-dose), and Day 10 (1 hr pre-dose and 2 hrs post dose).|Baseline and Days 1, 4, 7, and 10|Safety Population|||millimeters of mercury (mmHg)||Standard Deviation|Mean
1469909|NCT00708110|Primary|Number of Participants Who Received the Indicated Concomitant Medications During the Study Period|Concomitant medications received during the study period are presented by generic term. Only those concomitant medications that were received by at least two participants are presented. “Multiple ingredient” is the term used in the statistical package for items that contain more than one active ingredient.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population. Only those participants who received a concomitant medication were analyzed.|||participants|||Number
1469910|NCT00708110|Primary|Number of Participants With Any Non-serious Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline (Day 1) until Follow-up (average of 3 study weeks)|Safety Population: all participants who were randomized into the study with documented evidence of having received at least one dose of randomized treatment|||participants|||Number
1469911|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 10|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
1469912|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following the Last Repeat Administration on Day 10|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analysed for the placebo group.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1469913|NCT00708110|Primary|Time to the Maximum Observed Concentration (Tmax) of GSK1349572 Following the Last Repeat Administration on Day 10|tmax is defined as the time to the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||Hours||Full Range|Median
1469914|NCT00708110|Primary|Pre-dose Concentration (C0), Concentration at the End of the Dosing Interval (Ctau), Minimum Observed Concentration During One Dosing Interval (Cmin), and Maximum Obsevered Plasma Concentration (Cmax) of GSK1349572 Following the Last Repeat Administration|C0 is defined as the pre-dose concentration. Ctau is defined as the concentration at the end of the dosing interval. Cmin is defined as the minimum observed concentration during one dosing interval. Cmax is defined as the maximum obsevered plasma concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 10 at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
1469915|NCT00708110|Primary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK1349572 Following the Last Repeat Administration on Day 10|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-tau) is defined as the area under the concentration-time curve over the dosing interval. Blood samples for PK analysis of GSK1349572 were obtained on Day 10at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 10|PKS Population. No participants were analyzed for the placebo group.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1469916|NCT00708110|Primary|Apparent Clearance (CL/F) of GSK1349572 Following Dose Administration on Day 1|The CL/F is defined as the apparent total clearance of the drug from plasma after oral administration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
1469917|NCT00708110|Primary|Terminal Half-life (t1/2) of GSK1349572 Following Dose Administration on Day 1|The terminal half-life (t1/2) of GSK1349572 is defined as the time required for the plasma concentration of GSK1349572 to reach half of its original concentration. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Hours||Geometric Coefficient of Variation|Geometric Mean
1469918|NCT00708110|Primary|Time to Maximum Observed Concentration (Tmax) and Absorption Lag Time (Tlag) of GSK1349572 Following Dose Administration on Day 1|tmax is defined as the time to the maximum obsevered plasma concentration. Absorption lag time is defined as the time taken for a drug to appear in the systemic circulation following administration. tlag was estimated based on PK sampling times of 0 (pre-dose), 0.5, 1, 1.5, 2 3, 4, 6, 8, 12, and 24 hours post-dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, tmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed for the placebo group.|||Hours||Full Range|Median
1469919|NCT00708110|Primary|Maximum Observed Plasma Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24) of GSK1349572 Following Dose Administration on Day 1|Cmax is defined as the maximum observed plasma concentration, and C24 is defined as the concentration at 24 hours post dose. Blood samples for PK analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration. From the plasma concentration-time curve, Cmax was determined by standard non-compartmental analysis using WinNonlin Pro 4.1 or higher.|Day 1|PKS Population. No participants were analyzed in the placebo group.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
1469920|NCT00708110|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) and Over 24 Hours (AUC[0-24]) of GSK1349572 Following Dose Administration on Day 1|AUC is defined as the area under the GSK1349572 concentration-time curve as a measure of drug exposure. AUC(0-inf) is defined as the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. AUC(0-24) is defined as the area under the concentration-time curve from time zero (pre-dose) to24 hours. Blood samples for pharmacokinetic (PK) analysis of GSK1349572 were obtained on Day 1at pre-dose (within 15 minutes prior to dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post GSK1349572 dose administration.|Day 1|Pharmacokinetic Summary (PKS) Population: participants (par.) with an evaluable profile of GSK1349572 on Day 10. Par. were excluded if they vomited within 2 hours of dosing on Day 10, missed more than one dose 2 days prior to Day 10, and took prohibited concomitant medication during the treatment period. No par. were analyzed in the placebo group.|||Micrograms*hour per milliliter (µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
1469921|NCT00708110|Secondary|Number of Participants With HIV-1 RNA <400 Copies/mL and <50 Copies/mL|The number of participants who achieved plasma HIV-1 RNA levels <400 copies/mL and <50 copies/mL through Day 11 was measured.|Day 11|ITT(E) Population|||participants|||Number
1469922|NCT00708110|Secondary|Plasma HIV-1 RNA Rate of Decline Over 10 Days|The rate of decline of plasma HIV-1 RNA levels from Day 1 to Day 11 was measured.|Day 1 to Day 11|ITT(E) Population|||Log10 copies/mL/day||90% Confidence Interval|Mean
1469923|NCT00708110|Secondary|Median Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population|||Log10 copies/mL||Full Range|Median
1469924|NCT00708110|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA to Nadir (Maximum Change) at Day 11|Plasma HIV-1 RNA change from Baseline to the on-treatment nadir (maximum change) was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 11|ITT(E) Population|||Log10 copies/mL||Standard Deviation|Mean
1469925|NCT00708110|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 11|Change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) was calculated as the Day 11 value minus the Baseline value. Blood samples for the measurement of HIV-1 RNA levels were obtained throughout the treatment period (Day 1 to Day 11).|Baseline (Day 1) and Day 11|Intent to Treat Exposed (ITT[E]) Population: all participants who met study criteria and were randomized into the study with documented evidence of having received at least one dose of randomized treatment and at least one post-baseline HIV-1 RNA measurement|||Log10 copies/milliliter (log10 copies/mL||Standard Deviation|Mean
1469926|NCT00708097|Secondary|Enamel Fluoride Uptake (Demineralized Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population: All randomized participants with at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.|||μg*F/cm^2||Standard Error|Least Squares Mean
1469927|NCT00708097|Secondary|Enamel Fluoride Uptake (Sound Enamel Specimens)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.|Baseline to 14 days|ITT population:. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there are differences in the number of participants analyzed per treatment group.|||micrograms (μg)*F/centimeters(cm)^2]||Standard Error|Least Squares Mean
1469928|NCT00708097|Secondary|Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population. All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
1469929|NCT00708097|Secondary|Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|ITT population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
1469930|NCT00708097|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)|SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.|Baseline to 14 days|Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.|||Percentage SMHR||Standard Error|Least Squares Mean
1469931|NCT00708071|Primary|Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period||Through Postoperative Day 14 (± 1)|Safety Data Set|||Adverse Events|||Number
1469932|NCT00708071|Secondary|Participants' Assessment of Side of Face Preference (SoC and FS VH S/D 4)|Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another.|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
1469933|NCT00708071|Secondary|Differences in Subjects' Assessments of Numbness for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol|||Scores on a scale||Full Range|Median
1469934|NCT00708071|Secondary|Differences in Subjects' Assessments of Pain for Each Side of Face (SoC and FS VH S/D 4)|"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Days 1, 3, 5, 7,10, and 14|Per Protocol|||Scores on a scale||Full Range|Median
1469935|NCT00708071|Secondary|Differences From Day 0 in Two-Point Discrimination Tests Days 3, 7, 10, 14|Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points|Postoperative Days 3, 7, 10, and 14|Per protocol|||mm||Full Range|Median
1469936|NCT00708071|Secondary|Participants With Hematoma/Seroma During the Study|Investigators assessed each side of the face for the presence of hematoma/seroma|Through Postoperative Day 14 (± 1)|Per protocol|||participants|||Number
1469937|NCT00708071|Secondary|Participants With Hematoma/Seroma|Investigators assessed each side of the face for the presence of hematoma/seroma|Days 0, 1, 3, 5, 7,10, and 14|Per Protocol|||Participants|||Number
1469938|NCT00708071|Secondary|Total Volume of Drainage on Each Side of the Face||24 hours postoperative|Per Protocol|||mL||Full Range|Median
1469939|NCT00708071|Secondary|Resolution of Edema as Assessed by Investigators.|Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil)|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
1469940|NCT00708071|Secondary|Resolution of Ecchymosis as Assessed by Investigators|Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all))|Postoperative Days 1, 3, 5, 7, 10, and 14|Per Protocol|||participants|||Number
1469941|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 14|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469942|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 10|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469943|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 7|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469944|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 5|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469945|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 3|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469946|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by Investigator- Day 1|"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469947|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 14|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469948|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 10|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469965|NCT00708071|Primary|Visual Comparison of Ecchymosis at Postoperative Day 3|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 3|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1469968|NCT00708032|Secondary|Subjective Overall Comfort After 12 Months of Daily Wear|subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1469949|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 7|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469950|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 5|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469951|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 3|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469952|NCT00708071|Secondary|Difference in Marchac Grades of Edema Between Two Sides of Face Assessed by Investigator Day 1|"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4.~Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469953|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by a Blinded On-site Evaluator-Day 3|"Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Postoperative Day 3|Per Protocol|||Scores on a scale||Full Range|Median
1469954|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 14|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 14|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469955|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 10|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 10|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469956|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 7|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469957|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 5|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469958|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 3|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469959|NCT00708071|Secondary|Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1|"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests."|Through Postoperative Day 1|Per Protocol|||Scores on a scale||90% Confidence Interval|Median
1469960|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 14|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 14|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1469961|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 10|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 10|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1469962|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 7|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 7|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1469963|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 5|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 5|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1469964|NCT00708071|Secondary|Visual Comparison of Ecchymosis at Day 1|Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs.|Through Postoperative Day 1|Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis.|||participants|||Number
1469969|NCT00708032|Secondary|Visual Acuity After 12 Months of Wear|Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||logMar||Standard Deviation|Mean
1469970|NCT00708032|Secondary|Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.|Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.|at 12 months|Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.|||units on a scale||Standard Deviation|Mean
1469971|NCT00708019|Secondary|Worst Pain Intensity Score|"Worst pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in worst pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks||||units on a scale||95% Confidence Interval|Mean
1469972|NCT00708019|Primary|Average Pain Intensity Score|"Average pain was measured using a 0 (no pain) to 10 (worst pain imaginable) numeric rating scale on a daily basis.~Change in average pain intensity between the two intervention groups was evaluated from enrollment to the end of the study (i.e., 10 weeks)."|10 weeks||||units on a scale||95% Confidence Interval|Mean
1469973|NCT00707993|Secondary|Incidence of Glycosylated Hemoglobin Decrease From Baseline.|The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percentage of participants|||Number
1469974|NCT00707993|Secondary|Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%|The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percentage of participants|||Number
1469975|NCT00707993|Secondary|Change From Baseline in High Sensitivity C-reactive Protein|The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/L||Standard Error|Least Squares Mean
1469976|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Triglycerides)|The change in triglycerides measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1469977|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)|The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1469978|NCT00707993|Secondary|Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)|The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1469979|NCT00707993|Secondary|Change From Baseline in Serum Lipids (Total Cholesterol)|The change in total cholesterol measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1469980|NCT00707993|Secondary|Change From Baseline in Body Weight|The change in body weight measured at each week indicated including final visit from baseline.|Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||kg||Standard Error|Least Squares Mean
1469981|NCT00707993|Secondary|Homeostasis Model Assessment of Beta Cell Function|The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||percent score of beta cell function||Standard Error|Least Squares Mean
1469982|NCT00707993|Secondary|Change From Baseline in Proinsulin/Insulin Ratio|The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||ratio||Standard Error|Least Squares Mean
1469983|NCT00707993|Secondary|Change From Baseline in Insulin|The change between the value of insulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mcIU/mL||Standard Error|Least Squares Mean
1469984|NCT00707993|Secondary|Change From Baseline in Fasting Proinsulin|The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.|Baseline, Week 12, Week 26, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||pmol/L||Standard Error|Least Squares Mean
1469985|NCT00707993|Secondary|Change From Baseline in 2-hour Postprandial Glucose|The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.|Baseline and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set).|||mg/dL||Standard Error|Least Squares Mean
1469986|NCT00707993|Secondary|Change From Baseline in Fasting Plasma Glucose|The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.|All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
1469987|NCT00707993|Secondary|Incidence of Hyperglycemic Rescue|The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis.|||participants|||Number
1469988|NCT00707993|Secondary|Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).|The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.|On Occurrence (up to 52 weeks).|All randomized participants who had at least 1 dose of study medication (full analysis set).|||participants|||Number
1469989|NCT00707993|Secondary|Incidence of Hypoglycemia|Percentage of participants with at least one hypoglycemic episode during 52 week study.|On occurrence (up to 52 weeks).|Percentages based on the number of Safety Set participants in each treatment group.|||percentage of participants|||Number
1469990|NCT00707993|Secondary|Change From Baseline in Glycosylated Hemoglobin|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline.|Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1469991|NCT00707993|Primary|Change From Baseline in Glycosylated Hemoglobin at Week 52.|The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.|Baseline and Week 52.|Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
1469992|NCT00707980|Secondary|Health Care Resource Utilization Assessed by the Health Economic Assessment Questionnaire|Healthcare resource utilization was assessed by the Health Economic Assessment (HEA) questionnaire, which monitors participants absenteeism from work, as well as resource use such as visits to a general practitioner, outpatient and inpatient services, hospitalization, medications, and other relevant services over the past 8 weeks.|Baseline and Week 52|Safety set with available data|||participants|||Number
1469993|NCT00707980|Secondary|Change From Baseline to the Final Visit in the Sheehan Disability Scale|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.|||scores on a scale||Standard Deviation|Mean
1469994|NCT00707980|Secondary|Change From Baseline to the Final Visit in 36-item Short-form Health Survey (SF-36)|The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are: 1. Limitation in physical activities because of health problems. 2. Limitations in usual role activities because of physical health problems. 3. Bodily pain. 4. Limitations in social activities because of physical or emotional problems. 5. General mental health (psychological distress and well-being). 6. Limitations in usual role activities because of emotional problems. 7. Vitality (energy and fatigue). 8. General health perception. Each scale ranges from 0 (best) - 100 (worst).|Baseline and Week 52|Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available Final Visit data.|||scores on a scale||Standard Deviation|Mean
1469995|NCT00707980|Secondary|Change From Baseline in the Clinical Global Impression of Severity of Illness Scale|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1470036|NCT00707746|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470703|NCT00703391|Primary|Creatine Kinase (CK)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||IU/L||Standard Deviation|Mean
1469996|NCT00707980|Secondary|Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score|The HAM-A is an anxiety rating scale consisting of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behavior at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 to 56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Total scores above 30 are rare, but indicate very severe anxiety. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1469997|NCT00707980|Secondary|Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 4, 24 and 52|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1469998|NCT00707980|Secondary|Change From Baseline in Hamilton Depression Scale-24 Item (HAM-D24) Total Score|The HAM-D24 is a clinician-rated 24-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 74 where a higher score indicates a greater depressive state. Final Visit includes data from Week 52 or earlier for participants who didn't complete the 52 weeks.|Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52.|"Participants in the safety analysis set who had at least 1 post-baseline efficacy measurement, and with available data. n indicates the number of patients included in the analysis at each time point."|||scores on a scale||Standard Deviation|Mean
1469999|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Vital Sign Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding. The definition of clinically significant is included in the table below for each parameter. SSBP = supine systolic blood pressure; SDBP = supine diastolic blood pressure.|Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44 and 52|Safety set|||participants|||Number
1470000|NCT00707980|Primary|Number of Participants With Adverse Events (AEs)|"The intensity (severity) of each AE was defined as:~Mild: caused minimal discomfort and did not interfere in a significant manner with normal activities.~Moderate: sufficiently uncomfortable to produce some impairment of normal activities.~Severe: incapacitating, preventing the patient from participating in normal activities.~The causal relationship between an AE and study drug was assessed by the investigator as Probable, Possible or Not Related; Related=AEs with causality of Possibly or Probably. A serious AE (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, led to a congenital anomaly/birth defect, or was an important medical event that either jeopardized the patient, required intervention to prevent any of the SAEs defined above, a suicide attempt or an abortion."|From the first dose of open-label study drug until 4 weeks after the last dose (up to 56 weeks)|Safety set|||participants|||Number
1470001|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula; QTcF = QT interval corrected using Fridericia's formula.|Weeks 4, 12, 24, 36 and 52|Safety set|||participants|||Number
1470002|NCT00707980|Primary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant (as defined in the table below) serum chemistry, hematology or urinalysis result. ULN = upper limit of normal; LLN = Lower limit of normal.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|Safety set|||participants|||Number
1470003|NCT00707980|Primary|Physical Examination Findings|"Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area.~Each system was assessed as normal or abnormal."|Baseline and Week 52|The safety set included all participants who enrolled and received at least 1 dose of open-label study medication. Results include data for participants with available data at each time point; 834 participants at Baseline and 524 participants at Week 52.|||participants|||Number
1470004|NCT00707967|Secondary|Number of Subjects With Significant Highly Active Anti-Retroviral Therapy (HAART) Changes|Recorded significant HAART change refers to one subject switching the Combivir drug to Truvada as planned by personal physician, with no relationship to vaccination, prior to study enrolment.|From Day 60 to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470005|NCT00707967|Secondary|Anti-M72 Specific Antibody Concentrations|Concentrations given in Enzyme-Linked Immunosorbent Assay units per milliliter (EL.U/mL) were expressed in Geometric Mean Concentrations (GMCs).|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
1470006|NCT00707967|Secondary|Cell Count of CD4+ T Cells|CD4+ T cell counts are defined by values greater than (>) 200 cells per cubic millimeters (mm3) at screening for enrolment into the study.|At Day 0, 30, 60 and 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||T cells/cubic millimeter||Inter-Quartile Range|Median
1470007|NCT00707967|Secondary|Frequency of M72 Specific CD4/8+ T Cells Expressing at Least One Cytokine and Another Signal Molecule|"Expressed cytokine combinations for CD4+ T cells were CD40-L and interleukin-2 [IL-2] or interferon-gamma [IFN-γ] or tumour necrosis factor-alpha [TNF-α]; IL-2 and CD40-L, or IFN-γ, or TNF-α; IFN-γ and CD40-L, or IL-2, or TNF-α; TNF-α and CD40-L, or IL-2, or IFN-γ.~For CD8+ T cells no vaccine induced responses were observed, thus results are presented only for the frequency of M72-specific CD8+ T cells expressing at least two cytokines."|At Day 0, 30, 60 and 210|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
1470008|NCT00707967|Secondary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation 4/8 (CD4/8+) T Cells Expressing at Least Two Different Cytokines|Among cytokines expressed were interleukin-2 [IL-2] and/or interferon-gamma [IFN-γ] and/or tumour necrosis factor-alpha [TNF-α] and/or cluster of differentiation 40-ligand [CD40-L]. Analysis of cytokines expression was done by means of in vitro flow cytometry using intracellular cytokine staining (ICS).|At Day 0, 30, 60 and 210|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||T cells/million cells||Inter-Quartile Range|Median
1470009|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470010|NCT00707967|Primary|Number of Subjects With Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470011|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Above Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470012|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470013|NCT00707967|Primary|Number of Subjects With Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470014|NCT00707967|Primary|Number of Subjects With Biochemical and Haematological Levels Below Normal|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470015|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470016|NCT00707967|Primary|Number of Subjects With Normal Haematological Levels|Among biochemical and haematological parameters assessed were haematocrit [Hct], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470017|NCT00707967|Primary|Number of Subjects With Normal Biochemical and Haematological Levels|Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CREA], eosinophil [EOS]. Levels of haematological/biochemical parameters assessed in relation to normal laboratory values were – normal, below and above.|At Day 0, 7, 30, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470018|NCT00707967|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity|During the entire study period, from Day 0 up to Day 210|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470035|NCT00707746|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470019|NCT00707967|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day period (Days 0-29) post vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470020|NCT00707967|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470021|NCT00707967|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.|During the 7-day period (Days 0-6) post vaccination following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.|||Subjects|||Number
1470022|NCT00707954|Secondary|Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin||18 days|||||||
1470023|NCT00707954|Secondary|Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr||19 days|||||||
1470024|NCT00707954|Primary|Safety: Adverse Events, Adverse Drug Reactions|In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.|19 days||||percentage of incidences|||Number
1470025|NCT00707915|Secondary|Clinical Global Impression (CGI)|The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8.|Week 8||||units on a scale||Standard Deviation|Mean
1470026|NCT00707915|Secondary|Leeds Sleep Evaluation Questionnaire (LSEQ)|The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8.|Week 8||||units on a scale||Standard Deviation|Mean
1470027|NCT00707915|Secondary|Critical Flicker Fusion Test (CFF)|The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded.|Baseline and week 8||||Hz||Standard Deviation|Mean
1470028|NCT00707915|Secondary|Clinical Stabilometric Platform (CSP)|CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded.|Baseline and week 8||||cm||Standard Deviation|Mean
1470029|NCT00707915|Secondary|A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8.|This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure.|Baseline and week 8||||units on a scale||Standard Deviation|Mean
1470030|NCT00707915|Primary|Completion Rate|The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects|8 weeks||||percentage of successful completers|||Number
1470031|NCT00707863|Primary|17-item Hamilton Depression Rating Scale (HAM-D)|Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
1470032|NCT00707759|Secondary|Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy||12 months|||||||
1470033|NCT00707759|Primary|Stimulation of Growth After 12 Months (Delta Z-score)||12 months||||units on a scale||Standard Deviation|Mean
1470034|NCT00707746|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470037|NCT00707746|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470038|NCT00707746|Other Pre-specified|Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||ratio||Standard Deviation|Mean
1470039|NCT00707746|Other Pre-specified|Percent Change From Baseline in the Ratio of Low-Density Lipoprotein Cholesterol to High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470040|NCT00707746|Other Pre-specified|Very Low Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470041|NCT00707746|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470042|NCT00707746|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470043|NCT00707746|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470044|NCT00707746|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470045|NCT00707746|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470046|NCT00707746|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470047|NCT00707746|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470048|NCT00707746|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470049|NCT00707746|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470050|NCT00707746|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Inter-Quartile Range|Median
1470051|NCT00707746|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Inter-Quartile Range|Median
1470052|NCT00707746|Primary|Summary of Participants With Adverse Events|"The on-treatment time frame spanned the time during which the study drug was administered until the later of the primary efficacy time point and 14 days beyond the last study drug date.~Adverse events (AEs) were considered related if assessed by the Investigator as possibly, probably or definitely related to study drug.~Severity was assessed as:~Mild-symptom barely noticeable to the patient or do not make the patient uncomfortable;~Moderate-symptom makes the patient uncomfortable, affects performance of daily activities;~Severe-symptom causes the patient severe discomfort, may cause cessation of treatment with the study drug.~Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention."|Pre-treatment (prior to first dose), On-treatment (Day 1 to week 28), Post-treatment (Week 28-52)|Safety set of all randomized participants who received at least one injection of study drug.|||participants|||Number
1470053|NCT00707746|Primary|Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full analysis set|||mg/dL||Standard Deviation|Mean
1470054|NCT00707746|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL-C was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of baseline||Standard Deviation|Mean
1470055|NCT00707655|Secondary|Tumor Response Rate/ Complete or Partial Response||2 years||||participants|||Number
1470056|NCT00707655|Secondary|Best Overall Tumour Response|Best overall tumor response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR|2 years||||participants|||Number
1470057|NCT00707655|Primary|Adverse Events|Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.|Overall study||||participants|||Number
1470058|NCT00707577|Primary|Weight Loss|Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program|1 year||||pounds||Standard Deviation|Mean
1470059|NCT00707486|Secondary|Incidence of Post Surgical Sequelae||1 week post surgery||||Percent of Participants|||Number
1470060|NCT00707486|Primary|Time to Hemostasis|This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.|Minutes After Application|Participants served as their own control thus the total amount of participants is reflected in both of the outcome measures.|||Minutes|Participants|Standard Error|Mean
1470061|NCT00707447|Secondary|Emotional Well-being/ Depression (CES-D)|"The Center for Epidemiologic Studies Depression Scale (CES-D) consists of 20 items scored from 0 to 3. Scores are summated, with raw score ranging from 0 to 25. Higher Scores idicate a higher depressive state.~Mean change in depression score (CES-D) after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1470156|NCT00706849|Secondary|Total Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1470062|NCT00707447|Secondary|Psychological Well-being (WHO-5)|"The WHO (Five) Well-being index consists of 5 items on the overall well-being over the last two weeks. Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25. Then the scores are transformed to 0-100 by multiplying by 4, with higher scores meaning better well-being.~Mean change in psychological well-being score (WHO-5) after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1470063|NCT00707447|Secondary|Eating Behavior (TFEQ) - Hunger|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale hunger consists of 14 Item with a minimum score of 0 and a maximum score of 14. Low scores indicate an eating behavior strongly depending on feelings of hunger.~Mean change in the TFEQ - hunger scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1470064|NCT00707447|Secondary|Eating Behavior (TFEQ) - Disinhibition|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale disinhibition consists of 16 Item with a minimum score of 0 and a maximum score of 16. High scores indicate an uninhibited eating behavior strongly depending on external cues.~Mean change in the TFEQ - disinhibition scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1470065|NCT00707447|Secondary|Eating Behavior (TFEQ) - Cognitive Restraint|"The Three-Factor Eating Questionnaire (TFEQ) is a questionnaire used to assess food intake-behavior related research. The three factors of the TFEQ are: dietary restraint, disinhibition and hunger. The TFEQ contains 51 dichotomous Items (apply/ doesn't apply). The subscale cognitive restraint consists of 21 Item with a minimum score of 0 and a maximum score of 21. Low scores indicate an uninhibited eating behavior.~Mean change in the TFEQ - cognitive restraint scale after 12 months"|12 months||||units on a scale||Standard Deviation|Mean
1470066|NCT00707447|Secondary|Physical Exercise|Mean changes in physical exercise (in min/week) after 12 months|12 months||||minutes per week||Standard Deviation|Mean
1470067|NCT00707447|Secondary|Glucose Tolerance|Mean change in 2 hour postprandial oral glucose tolerance test (oGTT) (in mg/dl) after 12 months|12 months||||mg/dl||Standard Deviation|Mean
1470068|NCT00707447|Secondary|Fasting Glucose|Mean changes in fasting glucose (in mg/dl) after 12 month|12 months||||mg/dl||Standard Deviation|Mean
1470069|NCT00707447|Primary|Waist Circumference|Mean change in waist circumference (in cm) after 12 months|12 months||||cm||Standard Deviation|Mean
1470070|NCT00707447|Primary|Weight Change|Mean weight change (in kg) after 12 months|12 month|Intention to treat analysis (LOCF) and per protocol analysis for primary outcome and per protocol analysis for secondary outcome measures|||kg||Standard Deviation|Mean
1470071|NCT00707343|Primary|Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques|"The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis.~Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVmean of a 1 cm diameter region of normal contralateral white matter was also measured (F-18 FDG ratio lesion: contralateral white matter). For F-18 FLT, the maximum standardized uptake value (SUVmax) was measured at suspicious area of lesion enhancement. Patlak graphical analysis was applied using the metabolite-corrected plasma input function to obtain voxel-wise estimates of the FLT metabolic influx parameter (F-18 FLT Kimax)."|30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation||||Probability||95% Confidence Interval|Number
1470072|NCT00707239|Other Pre-specified|Duration of Intravenous Antibiotic Treatment, Hospital and Intensive Care Unit (ICU) Stay||Baseline up to Day 44 (30 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable for intravenous antibiotic treatment, hospital or ICU stay for each reporting group respectively.|||days||Full Range|Median
1470073|NCT00707239|Other Pre-specified|Time to Reach Half of the Maximum Observed Plasma Concentration and Time to Normalization of Concentrations (Tnorm) of Procalcitonin||Baseline up to Day 6|Data was not analyzed because there was no apparent change in procalcitonin concentration over time.|||hr||Full Range|Median
1470074|NCT00707239|Other Pre-specified|Maximum Observed Plasma Concentration of Procalcitonin (Cmaxpd) and Predicted Procalcitonin Plasma Concentration at 24 Hours (Cpd,24) and 48 Hours (Cpd,48)||Baseline up to Day 6|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
1470075|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Microbiological Outcome|Microbiological response:Eradication=baseline isolate not present in repeat culture from original infection site;Presumed Eradication=clinical response of cure precluded availability of specimen for culture;Persistence=baseline isolate present in repeat culture from original infection site;Presumed Persistence=culture data not available for participants with clinical response of failure;Superinfection=culture from primary infection site had new pathogen not identified as baseline isolate, clinical response was failure. MIC=lowest drug concentration with no visible growth of microorganism.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Data was not analyzed because correlation analysis could not be performed due to insufficient number of participants for whom data for both microbiological outcomes and tigecycline concentration was available.|||ratio||Standard Deviation|Mean
1470096|NCT00707057|Secondary|Global Evaluation for Dose 1|"Global evaluation for dose 1, either at the time of rescue or at dose 2 (hour 12), whichever came first were summarized. At the 12-hour time point but before Dose 2, or within 1 minute of rescue medication use (if it occurred before hour 12), the subject was to provide a Global Evaluation of Dose 1 of study medication on an 11 point PI-NRS in response to the following command:~“Select the number that best describes how you would rate this medication as a pain-reliever (select one number only).” The range went from 0 (Very poor) to 10 (Excellent)."|At 12 hours after Dose 1 or at time of rescue|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1470076|NCT00707239|Other Pre-specified|Correlation of AUC(0-24) to Minimum Inhibitory Concentration (MIC) Ratio (AUC [0-24]/MIC) of Tigecycline With Clinical Outcome|Clinical response:Cure =Initial SSx improved;CXR improved/stable;no other antibiotic for pneumonia;no worsening/new SSx. Failure=Persistence/worsening SSx;no clinical improvement/initial improvement with worsening; other antibiotic;CXR progression;death >study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reason;death in 2 days after dose 1 for any reason or >2 days but before TOC visit for non-pneumonia reason. MIC=lowest drug concentration with no visible growth of microorganism. AUC(0-24)/MIC:reported for cure and failure/indeterminate.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
1470077|NCT00707239|Other Pre-specified|Correlation of AUC (0-24) of Tigecycline With Nausea and Vomiting|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population PK analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Baseline up to Day 29 to 35 (15 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*hr/mL||Standard Deviation|Mean
1470078|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Tigecycline|AUC (0-24) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL. Model-predicted AUC (0-24) was calculated by multiplying AUC (0-12) by 2.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*hr/mL||Standard Deviation|Mean
1470079|NCT00707239|Other Pre-specified|Clearance (CL) of Tigecycline|Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the blood. It is defined as the volume of serum from which drug can be completely removed per unit of time.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Liter/hr||95% Confidence Interval|Mean
1470080|NCT00707239|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Tigecycline|AUC (0-12) = Area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12). Area under the serum concentration-time curve was derived from the population pharmacokinetic (PK) analysis by using each participant’s dose and the post-hoc individual estimated systemic CL, AUC (0-12) = Dose divided by CL.|Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
1470081|NCT00707239|Other Pre-specified|Time to Reach Maximum Observed Serum Concentration (Tmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hrs||Full Range|Median
1470082|NCT00707239|Other Pre-specified|Maximum Observed Serum Concentration (Cmax) of Tigecycline||Day 3, 4 or 5|CE population included those participants who met specified evaluability criteria for efficacy. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
1470083|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG)|Potentially clinically significant ECG data: Non-first values greater than 240 millisecond (msec) with increase of greater than or equal to 10 percent (%) from baseline for PR interval; Non-first values greater than or equal to 120 msec for QRS interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for corrected QT (QTc) interval; Non-first values greater than 460 msec with increase of greater than or equal to 5% from baseline for QTc using Framingham formula (QTc F).|Baseline up to Day 14 or LDOT|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1470084|NCT00707239|Other Pre-specified|Number of Participants With Abnormal Laboratory Examinations|Participants were evaluated for following laboratory parameters: albumin, alkaline phosphatase, amylase, urea (blood urea nitrogen [BUN]), total bilirubin, calcium, magnesium, carbon dioxide, international normalized ratio (INR), chloride, creatinine, glucose, lipase, potassium, phosphorus, aspartate aminotransferase (AST), alanine aminotransferase (ALT), sodium, total protein, hemoglobin, hematocrit, white blood cells, eosinophils, neutrophils, lymphocytes, platelets, prothrombin time, prothrombin activity and partial thromboplastin time.|Baseline up to Day 24 to Day 35 (10 to 21 days after LDOT)|mITT population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
1470085|NCT00707239|Other Pre-specified|Number of Participants Who Experienced Nausea or Vomiting||Baseline up to Day 29 to Day 35 (15 to 21 days after LDOT)|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of study medication.|||participants|||Number
1470095|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 2|"Global evaluation, maximum relief, and overall relief scores for dose 2 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 2 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 24 hours or at time of rescue between 12 and 24 hours|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1470086|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Participant Level Population at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure precluded the availability of a specimen for culture; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure; Superinfection = culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.|Up to Day 24 to 35 (10 to 21 days after LDOT)|ME population included participants who met specified evaluability criteria for efficacy, had culture taken from the infected site before first dose of study medication and had at least 1 pathogen, and at least 1 baseline pathogen was susceptible to tigecycline and imipenem/cilastatin regimens.|||percentage of participants|||Number
1470087|NCT00707239|Secondary|Percentage of Participants With Microbiological Response at the Pathogen Level Population at Test-of-Cure (TOC) Visit|Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for participants with a clinical response of failure; Indeterminate=unable to determine outcome for non-study drug/infection reasons; no baseline isolate; death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|Microbiologically Evaluable (ME) population:participants who met evaluability criteria for efficacy, had culture taken from infected site before dose 1 of study drug, had at least (>=)1 pathogen, >=1 pathogen was susceptible to tigecycline, imipenem/cilastatin regimen; ‘n’ = those participants who had specified pathogen for each group respectively.|||percentage of participants|||Number
1470088|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Ventilator Associated Pneumonia (VAP) and Non-VAP Participants at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|CE population included those participants who met specified evaluability criteria for efficacy. 'n' is signifying those participants who were evaluable for this measure and included in VAP (suffering from VAP) and non-VAP group (not suffering from VAP) for each group respectively.|||percentage of participants|||Number
1470089|NCT00707239|Secondary|Percentage of Participants With Clinical Response in Clinical Modified Intent-to-treat (c-mITT) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial SSx improved; CXR improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after LDOT)|c-mITT population included all participants who were randomly assigned to receive intravenous study medication and had clinical evidence of hospital-acquired pneumonia (HAP).|||percentage of participants|||Number
1470090|NCT00707239|Primary|Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit|Clinical response: Cure=All initial signs/symptoms of pneumonia (SSx) improved; chest x-ray (CXR) improved/stable; no other antibiotics for pneumonia; no worsening or new SSx. Failure=Persistence or worsening SSx; no clinical improvement or initial improvement with clinically important worsening; other antimicrobials for pneumonia; CXR progression; death > study day 2 due to pneumonia. Indeterminate=unable to determine outcome for non-study drug/infection reasons (e.g., lost to follow-up); death in 2 days after 1st dose for any reason, or >2 days but before TOC visit for non-pneumonia reason.|Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT])|CE population included those participants who met specified evaluability criteria for efficacy.|||percentage of participants|||Number
1470091|NCT00707174|Primary|The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants|Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.|24 months|All evaluable patients from both groups were compared|||participants|||Number
1470092|NCT00707161|Primary|Response Rate of Melanoma Lesions|Response rate of melanoma lesions was measured after treated with the trial agent.|2005-2010|Study terminated. Analysis not conducted.||||||
1470093|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 4|"Global evaluation, maximum relief, and overall relief scores for dose 4 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 4 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 48 hours or at time of rescue between 36 and 48 hours.|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1470094|NCT00707057|Secondary|Global Evaluation, Maximum Relief, and Overall Relief for Dose 3|"Global evaluation, maximum relief, and overall relief scores for dose 3 were summarized with descriptive statistics. The subject was to provide a description for the Global Evaluation, maximum relief and overall relief of Dose 3 of study medication on an 11 point PI-NRS: Global Evaluation: rate the study medication as a pain-reliever; Maximum Pain Relief: maximum pain relief received from the last dose; Overall Pain Relief: overall quantity of pain relief received from the last dose. The range went from 0 (Very poor or No relief) to 10 (Excellent or Complete relief)."|At 36 hours or at time rescue between 24 and 36 hours|Intention to Treat (ITT)|||Units on a scale||Standard Deviation|Mean
1470210|NCT00706641|Primary|Feasibility|Feasibility for this trial is defined as at least 60% (>=14 of 23) of patients completing study therapy in the absence of Dose Limiting Toxicity (DLT)|From enrollment to completion of radical cystectomy|All patients who completed dasatinib|||participants|||Number
1470097|NCT00707057|Secondary|Pain Relief and PID Scores at Individual Time Points for Dose 1|Pain relief and pain intensity difference (PID) scores at individual time points were summarized by descriptive statistics. The PID at each time point prior to dose 2 was derived by subtracting the pain intensity from the baseline pain intensity, so that a higher value was indicative of a greater improvement. Range of possible scores could be from 0 (no improvement) to 5 (greatest possible improvement)|24, 36, 48 hours after taking Dose 1|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1470098|NCT00707057|Secondary|Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1|Percentage of participants who require rescue medication (Lortab) at or prior to hour 8, hour 10 and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.|0-12 hours after taking Dose 1|Intention to treat (ITT)|||Percentage of participants||95% Confidence Interval|Least Squares Mean
1470099|NCT00707057|Secondary|Duration of Relief After Dose 1|Duration of relief was defined as the time to treatment failure (i.e.,taking rescue medication, or withdrawing due to lack of efficacy) up to the 12-hour time point. For those withdrawing from the study due to lack of efficacy prior to taking dose 2 or rescue medication, time to treatment failure was the time from dose 1 to the last assesment time. For those discontinuing from the study for any other reason, the time to treatment failure was censored at the last assessment time.|Time to rescue or time of Dose 2 (up to 12 hours following dose 1)|Intention to treat (ITT)|||Minutes||Full Range|Median
1470100|NCT00707057|Secondary|Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID)|The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity from baseline pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval (scale ranges from 0 to 10; 0=no pain relief and 10= complete pain relief) was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval (e.g., 4-12 hours in case of SPID 4-12). Time weighted TOTPAR for each specified interval was similarly derived.|0-12 hours after Dose 1|Intention to treat (ITT)|||Time weighted units on a scale||Standard Deviation|Mean
1470101|NCT00707057|Secondary|"Percentage of Subjects Achieving Meaningful Relief as Indicated by the Time Recorded on the Second Stopwatch Following First Perceptible Relief"|"Percentage(%) of subjects with confirmed first perceptible relief and meaningful relief after dose 1. Subjects that achieved both first perceptible relief and meaningful relief within the time allotted. The assigned censored time for No Pain Relief is 240 minutes. Meaningful relief is a subjective definition, based on each subject's determination of pain"|Within 4 hours post Dose 1|Intention to treat (ITT)|||Percent of participants||95% Confidence Interval|Number
1470102|NCT00707057|Secondary|Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1|"Percentage (percentage of total) of subjects with first perceptible relief within 1 hour of Dose 1. The assigned censored time for No Pain Relief was 240 minutes."|Within 1 hour of Dose 1|Intention to treat (ITT)|||Percent of participants||95% Confidence Interval|Number
1470103|NCT00707057|Secondary|"Time to Confirmed Meaningful Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. To determine the exact moment that the subject began to notice pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed meaningful relief was achieved if both stopwatches were stopped within the 4 hour observation period, when both initial and meaningful relief were observed. Meaningful relief is a subjective definition, based on each subjects determination of pain."|Within 4 hours post Dose 1|Intention to treat (ITT)|||Minutes||Full Range|Median
1470104|NCT00707057|Secondary|"Time to Confirmed First Perceptible Relief"|"When the subject was administered study medication at Time 0, the Study Coordinator started 2 stopwatches. In an effort to determine the exact moment that the subject began to obtain noticeable pain relief, the subject was instructed to stop the stopwatch when initial relief was observed and again when meaningful relief was achieved. Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also later stopped the second stopwatch indicating meaningful relief. The assigned censored time for No Pain Relief is 240 minutes."|Within 4 hours post Dose 1|Intention to treat (ITT)|||Minutes||Full Range|Median
1470105|NCT00707057|Primary|Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours|Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation.|24, 36, and 48 hours|Intention to treat (ITT)|||participants|||Number
1470106|NCT00707057|Primary|Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale|"Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID).~An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation."|from baseline to 12 hours after dose 1|Intention to treat (ITT)|||Units on a scale||Standard Deviation|Mean
1470130|NCT00706966|Primary|Change in Extent of Cancer|Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.|1 month, 6 months|One participant withdrew from the study|||participants|||Number
1482615|NCT00606138|Primary|Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs||Week 1, 2, 4; Month 2, 3, 4, 5, 6|||||||
1470107|NCT00707031|Other Pre-specified|Quality of Life: Change From Baseline in Patient's Satisfaction to Treatment (PAGI-QOL) at Week 24|PAGI-QOL: a 30–item self-administered questionnaire to measure health related QOL of patients with upper gastrointestinal disorders during past 2 weeks. Consists of 5 sub-scales. Each item rated on a 0-5 point Likert scale (0 [none of the time] to 5 [all the time]). Sub-scale score calculated by dividing sum of all items of subscale by number of items in the sub-scale. Total score calculated by taking mean of sub-scale scores. Sub-scale score and total score ranges from 0=none of the time (lowest score) to 5=all of the time (highest score) with lower scores indicating better QOL. The on-treatment period for this variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline PAGI-QOL assessment during on-treatment period.|||units on a scale||Standard Error|Least Squares Mean
1470108|NCT00707031|Other Pre-specified|Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from hypoglycemia in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration, for up to 116 weeks|Safety population included all randomized patients who received at least 1 dose of study drug, regardless of the amount of treatment administered.|||participants|||Number
1470109|NCT00707031|Other Pre-specified|Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
1470110|NCT00707031|Secondary|Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 milligram/deciliter (mg/dL) (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c > 8.5%. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
1470111|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1470112|NCT00707031|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24|The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Week 24|mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
1470113|NCT00707031|Secondary|Change From Baseline in Body Weight at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.|||kilogram||Standard Error|Least Squares Mean
1470114|NCT00707031|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change was calculated by subtracting baseline value from Week 24 value. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 1 day after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
1470276|NCT00706433|Secondary|Stinging/Burning 48 Hours Post PDT #1|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|48 hours post PDT #1|ITT observed|||participants|||Number
1470115|NCT00707031|Primary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Absolute Change = HbA1c value at Week 24 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is time from the first dose of study drug and up to 3 days after the last dose of study drug, on or before Visit 11 (Week 24) or Day 169 if Visit 11 is not available, and before the introduction of rescue therapy. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.|Baseline, Week 24|mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
1470116|NCT00706992|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years||||Participants|||Number
1470117|NCT00706992|Primary|Percentage of Participants With Immunologic Response|Percentage of participants with an immunologic response of >20 spots/100,000 cells measured by IFN gamma secretion using enzyme linked immunosorbent spot (ELISPOT) assay. This was done using ELISPOT assay which measures immune response at the single cell level.|9/24/08-10/9/12|Arms 1-6 were evaluated in patients who received F5 cells. Arm 7 was not included in the evaluation because the participants did not receive F5 cells.The immunological response was measured for the total percentage of pts whom specimen was available for analysis. This was not captured per Arm. No statistically significant responses were observed.|||Percentage of participants|||Number
1470118|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At 6-month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1470119|NCT00706979|Primary|A 24 Hour Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|Serious quit attempt of >=24hrs, which fits the CDC’s definition of a quit attempt.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1470120|NCT00706979|Secondary|Abstinence From Cigarette Smoking, Where Abstinence is Defined as Self-report of Not Smoking at All for 7 Consecutive Days||At any point during the study|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1470121|NCT00706979|Primary|A Serious Quit Attempt in Which the Participant Intends to Permanently Stop Smoking|The primary outcome was an attempt to quit smoking for good. To distinguish from a PQA, we specifically asked participants if they tried to quit smoking with the intent of quitting for good. Quit attempts were defined as any self-defined attempt to quit for good.|From study enrollment through six month follow-up|All analyses were based on intent-to-treat approach; participants with missing data were assumed to have not made any quit attempts or quit.|||participants|||Number
1470122|NCT00706966|Secondary|Testosterone Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||ng/dL||Standard Deviation|Mean
1470123|NCT00706966|Secondary|Dihydrotestosterone (DHT) Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||ng/dL||Standard Deviation|Mean
1470124|NCT00706966|Secondary|Total PSA Over Time||Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 for the 6-month Mean(SD) levels.|||ng/mL||Standard Deviation|Mean
1470125|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - SQLI|The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to 6 months; thus, n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1470126|NCT00706966|Secondary|Health-Related Quality of Life (HRQL) Indices Over Time - FACE|Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1470127|NCT00706966|Secondary|Symptom Indices Over Time - IIEF-5|The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction|Baseline, 1, 3, and 6 months|One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1470128|NCT00706966|Secondary|Symptom Indices Over Time - IPSS|IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).|Baseline, 1, 3, and 6 months|Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.|||units on a scale||Standard Deviation|Mean
1470129|NCT00706966|Secondary|Adverse Events Indicative of Safety of Dutasteride|Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.|Baseline, 1, 3, and 6 months||||adverse events|||Number
1482616|NCT00606138|Primary|Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination||Month 6||||number of events|||Number
1470131|NCT00706914|Other Pre-specified|Change From Baseline in Normalized Area Under the Curve (0-3 hr) of Forced Expiratory Volume in One Second (FEV1)|FEV1 values obtained at 30, 60, 120, and 180 minutes after the morning study drug dose|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
1470132|NCT00706914|Other Pre-specified|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)||Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
1470133|NCT00706914|Other Pre-specified|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)|The trough value for each pulmonary function parameter was defined as the mean of the two greatest readings assessed 23 hours and 24 hours following the administration of the morning dose of the previous day|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Liters||95% Confidence Interval|Mean
1470134|NCT00706914|Primary|Change From Baseline in Weekly Average Daily (24 Hour) Sputum Volume Scores|Sputum Volume Score Scale: 0 = None; 1 = The amount of one teaspoon; 2 = The amount of one tablespoon; 3 = More than one tablespoon|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Units on a scale||95% Confidence Interval|Mean
1470135|NCT00706914|Primary|Change From Baseline in Weekly Average Nocturnal Symptom Scores|Nocturnal Symptom Score Scale: 0 = None; 1 = Symptoms causing early awakening or awakening once during the night; 2 = Symptoms causing early awakening or awakening two or more times during the night; 3 = Symptoms causing awakening for most time during the night, 4 = Symptoms which were so severe that I could not sleep at all|Week 4 of treatment|Includes the number of patients in the randomized population with available analysis value at both baseline and a specific time point. Randomized population defined as all patients in the screened population who were randomized to a treatment group in the study.|||Units on a scale||95% Confidence Interval|Mean
1470136|NCT00706901|Secondary|Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Days of drug use||Standard Deviation|Mean
1470137|NCT00706901|Primary|Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Number of 12-step sessions attended||Standard Deviation|Mean
1470138|NCT00706901|Primary|Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Number of treatment sessions||Standard Deviation|Mean
1470139|NCT00706901|Primary|Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Intent to treat population (at least one GMI session attended)|||Standard alcohol drinks||Standard Deviation|Mean
1470140|NCT00706901|Primary|Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)|||Days of binge drinking||Standard Deviation|Mean
1470141|NCT00706901|Primary|Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days|Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell & Sobell, 1992).|One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days|Intent to treat population (at least one GMI session attended)|||Days Using Alcohol||Standard Deviation|Mean
1470142|NCT00706849|Other Pre-specified|High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1470491|NCT00705367|Primary|Short-term Period: Mean Heart Rate|Vital signs measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||beats per minute||Standard Deviation|Mean
1470143|NCT00706849|Other Pre-specified|Percent Change From Baseline in High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|High-density lipoprotein cholesterol (HDL-C) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1470144|NCT00706849|Other Pre-specified|Apolipoprotein A1 at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1470145|NCT00706849|Other Pre-specified|Percent Change From Baseline in Apolipoprotein A1 at the Primary Efficacy Time Point|Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1470146|NCT00706849|Other Pre-specified|Ratio of LDL Cholesterol to HDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||ratio||Inter-Quartile Range|Median
1470147|NCT00706849|Other Pre-specified|Percent Change From Baseline in the Ratio of LDL Cholesterol to HDL Cholesterol at the Primary Efficacy Time Point|The ratio of low-density lipoprotein (LDL) cholesterol to high-density lipoprotein (HDL) cholesterol was measured at Baseline and the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1470148|NCT00706849|Other Pre-specified|Very Low Density Lipoprotein at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1470149|NCT00706849|Other Pre-specified|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Very low density lipoprotein (VLDL) cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1470150|NCT00706849|Other Pre-specified|Lipoprotein (a) at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1470151|NCT00706849|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) at the Primary Efficacy Time Point|Lipoprotein (a) was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1470152|NCT00706849|Other Pre-specified|Triglycerides at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Inter-Quartile Range|Median
1470153|NCT00706849|Other Pre-specified|Percent Change From Baseline in Triglycerides at the Primary Efficacy Time Point|Triglycerides were measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Inter-Quartile Range|Median
1470154|NCT00706849|Secondary|Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1470155|NCT00706849|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point|Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1470492|NCT00705367|Primary|Short-term Period: MeanSystolic and Diastolic Blood Pressure|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||mm Hg||Standard Deviation|Mean
1470157|NCT00706849|Secondary|Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point|Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1470158|NCT00706849|Secondary|Apolipoprotein B at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1470159|NCT00706849|Secondary|Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point|Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||percentage of baseline||Standard Deviation|Mean
1470160|NCT00706849|Primary|LDL Cholesterol at Baseline and at the Primary Efficacy Time Point|The primary efficacy time point (PET) was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|Full Analysis Set|||mg/dL||Standard Deviation|Mean
1470161|NCT00706849|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point|LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides <400 mg/dL, LDL-C was obtained using Friedewald’s calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.|Baseline (the average of the screening and Day 1 pre-treatment assessments) and the Primary Efficacy Time point (PET; Week 28 or the post-baseline visit closest to 14 days after the last dose).|The Full Analysis Set, which consisted of all randomized patients who received at least 1 injection of study drug (mipomersen or placebo) and with a valid baseline and at least 1 post-baseline LDL-C measurement.|||percentage of Baseline||Standard Deviation|Mean
1470162|NCT00706836|Secondary|To Evaluate the Effects of an Anxiolytic Drug Versus Placebo on Eye Blink Startle Response at Rest and During Emotional Stimuli (Anxiety Potentiated Startle, APS) as Well as on Clinical Scales.||Week 1, 2, 3|||||||
1470163|NCT00706836|Primary|Effect of Pregabalin (Two Doses) Versus Placebo|Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales.|Week 1, 2, 3 (Cross-over Design)|Cross-over design, complete data available for all participants. Total number of participants in study is 16; all subjects received all 3 arms of treatment in randomized order.|||% signal change L amygdala + anticipn||Standard Error|Mean
1470164|NCT00706823|Secondary|Number of Attempts|The number of attempts taken to place the device|Before intubation||||participants|||Number
1470165|NCT00706823|Secondary|Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization|When the fiberoptic scope was placed in the gastirc drain tube of the i-gel, if the esophageal mucosa was visible and the stomach was readily accessible, then placement was considered succussful.|after intubation|Only the -gel has a gastric drainage tube--the uLMA does not. Thus, only those receiving the i-gel were assessed for this measure.|||participants|||Number
1470166|NCT00706823|Primary|Leak Pressure|After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.|duration of intubation||||cm of H2O||Standard Deviation|Mean
1470167|NCT00706823|Secondary|Number of Participants With Oropharyngeal Discomfort|Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.|post operative, immediately and 24 hrs after intubation||||participants|||Number
1470168|NCT00706823|Secondary|Level of Difficulty for Intubation|Ease of SGA insertion and intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = very easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = very difficult).|duration of intubation||||participants|||Number
1470169|NCT00706823|Primary|Time Required for Intubation|The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).|duration of intubation||||seconds||Standard Deviation|Mean
1470170|NCT00706810|Secondary|Median Progression-free Survival Rates of the Treatment Population.|Response and progression will be evaluated in this study using measurements from the MRI/CT scans. Measurements will be made of the image slice with the largest cross sectional area. Two orthogonal measures will be made to determine maximal AP and lateral dimensions. Progression of disease will be defined as a greater than 25% increase of largest cross sectional area by two orthogonal measurements, taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|31 months||||months||Full Range|Median
1470171|NCT00706810|Primary|Number of Participants Experiencing Serious Adverse Events Including But Not Limited to Hospitalizations, Deaths Related to Treatment, or Other Incapacitating Conditions.|Adverse Events assessed in accordance with CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.|two years||||participants|||Number
1470172|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)|EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on scale||Standard Deviation|Mean
1470173|NCT00706797|Secondary|Health Related Quality of Life: EuroQol-5D Health Index|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on scale||Standard Deviation|Mean
1470174|NCT00706797|Secondary|Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)|Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470175|NCT00706797|Secondary|Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)|Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.|Week 12, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470176|NCT00706797|Secondary|Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period|Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.|Week 4, Week 12, Week 24, Week 40, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||mg||Standard Deviation|Mean
1470177|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 90% (ACR90) Response|American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470178|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 70% (ACR70) Response|American College of Rheumatology 70% (ACR70) response: responder = ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470179|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 50% (ACR50) Response|American College of Rheumatology 50% (ACR50) response: responder = ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470180|NCT00706797|Secondary|Percentage of Participants With American College of Rheumatology 20% (ACR20) Response|American College of Rheumatology 20% (ACR20) response: responder = ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470181|NCT00706797|Secondary|Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria|Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.|Week 12, Week 24, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470182|NCT00706797|Secondary|Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant’s assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission. DAS28 response of >0.6 defined as decrease in DAS28 >0.6 (change in DAS28 < -0.6).|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1482617|NCT00606138|Primary|The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)||Week 4; Month 6||||percentage of change (mean)||Standard Deviation|Mean
1470183|NCT00706797|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470184|NCT00706797|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.60)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.|Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470185|NCT00706797|Secondary|Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)|Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.1=higher disease activity; <3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (change in DAS28 < -1.2).|Baseline, Week 12, Week 24, and Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants|||Number
1470186|NCT00706797|Secondary|Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52|Radiographic non-progression determined based on TSS change <0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52, Last observation carried forward (LOCF)|mITT; efficacy data not analyzed due to early termination of the study.|||percentage of participants||95% Confidence Interval|Number
1470187|NCT00706797|Secondary|Change From Baseline in Joint Space Narrowing at Week 52|Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
1470188|NCT00706797|Secondary|Change From Baseline in Erosions at Week 52|Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|mITT; efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
1470189|NCT00706797|Primary|Change From Baseline in Modified Total Sharp Score (TSS) at Week 52|Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.|Baseline, Week 52|Modified intent-to-treat (mITT) population including all participants with an erosion at randomization confirmed by the blinded expert assessor, received at least 1 dose of subject treatment, and had data for randomization and 1 post randomization X-ray. Efficacy data not analyzed due to early termination of the study.|||scores on a scale||Standard Deviation|Mean
1470190|NCT00706784|Primary|Serum Leuprolide Levels After EVA Ring Transvaginal Drug Delivery System Insertion||8 hours||||pg/ml||Standard Deviation|Mean
1470191|NCT00706719|Secondary|Follicle Stimulating Hormone (FSH) Levels|FSH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mIU/mL||Standard Deviation|Mean
1470192|NCT00706719|Secondary|Luteinizing Hormone (LH) Levels|LH levels were measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mIU/mL||Standard Deviation|Mean
1470193|NCT00706719|Primary|Semen Volume|Semen volume was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||mL||Standard Deviation|Mean
1470194|NCT00706719|Primary|Motile Total Sperm Count|Motile total sperm count was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||millions sperm||Standard Deviation|Mean
1470195|NCT00706719|Primary|Sperm Concentration|Total sperm concentration was measured.|Baseline, Month 3, Month 6, Follow-Up (Month 7)|Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.|||millions sperm/mL||Standard Deviation|Mean
1470196|NCT00706706|Secondary|One Year Survival Probability|One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)|Safety population included those participants who had taken at least one dose of the study drug.|||Percent chance of survival||95% Confidence Interval|Number
1470358|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Body Mass Index on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||percentage of participants|||Number
1470197|NCT00706706|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.|||Weeks||95% Confidence Interval|Median
1470198|NCT00706706|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Per protocol (PP) population included those participants who had the disease under study, measurable disease and an adequate baseline disease assessment and had taken at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
1470199|NCT00706706|Primary|Progression-free Survival (PFS)|"Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)|Safety population included those participants who had taken at least one dose of the study drug.|||Weeks||95% Confidence Interval|Median
1470200|NCT00706654|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1470201|NCT00706654|Secondary|Percentage of Responders up to Week 38|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1470202|NCT00706654|Secondary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse||Baseline to the end of the study (Week 38)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
1470203|NCT00706654|Primary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26|A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline to Week 26|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1470204|NCT00706641|Secondary|Increase in Cas3 Expression|Cas3 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
1470205|NCT00706641|Secondary|Reduced Ki-67 Expression|Ki-67 levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
1470206|NCT00706641|Secondary|Post-Cystectomy Pathologic Stage|Tumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M) T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed M0=No distant metastases, M1=Distant metastases present|Staged Post-Cystectomy and dasatinib treatment||||percentage of particpants||95% Confidence Interval|Number
1470207|NCT00706641|Secondary|Pathologic Complete Response (pCR) Rate|Pathologic complete response (pCR) rate is defined as no residual evidence of muscle-invasive disease at cystectomy (< pT0).|24 months|23 participants completed treatment and underwent radical cystectomy.|||participants|||Number
1470208|NCT00706641|Secondary|Reduced pSFK Expression|pSFK levels were analyzed pre and post treatment|Baseline to post dasatinib therapy|Sufficient tumor suitable for Immuno-Histochemistry (IHC) analysis was available from 20 patients|||participants|||Number
1470209|NCT00706641|Secondary|Grade 3/4 Toxicities|Report grade 3/4 toxicities during treatment with dasatinib prior to radical cystectomy in patients with muscle invasive transitional cell carcinoma of the bladder.|Time of consent through 30 days after treatment discontinuation|24 patients received treatment, 1 patient ineligible due to small cell histology after starting dasatinib treatment and was not evaluable.|||percentage of particpants|||Number
1470211|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy|"Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment (C12,14 for BIBF1120 ; C24,7 and C24,14 for BIBW2992)~C12,14: plasma concentration at 12 hours Day 14"|Day7, Day 14|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1470212|NCT00706628|Secondary|Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy|Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment|Day 15, Day 29 and Day 57|Pharmacokinetics (PK) data set: All patients from whom PK samples were received in the bioanalytical laboratories were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
1470213|NCT00706628|Secondary|Changes in Safety Laboratory Parameters|Changes in safety laboratory Parameters reported as adverse events|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set|||percentage of participants|||Number
1470214|NCT00706628|Secondary|Incidence and Worst Intensity of Adverse Events With Grading According CTCAE|Incidence and worst intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).|from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)|Treated Set|||percentage of participants|||Number
1470215|NCT00706628|Secondary|Overall Survival (Time to Death)|Overall survival (time to death) was calculated in days from baseline to the date of reporting of death. Time is expressed in Median number of days.|start of treatment until 28 days after end of treatment (Up to 52 weeks)|FAS|||days||95% Confidence Interval|Median
1470216|NCT00706628|Secondary|Time to Progression|"Time from first administration of study drug until disease progression according to composite endpoint.~Time is expressed in Median number of days."|start of treatment until end of the treatment (Up to 48 weeks)|FAS|||days||95% Confidence Interval|Median
1470217|NCT00706628|Secondary|Duration of RECIST Response|"Time from first observation of response (PR, CR, confirmed or unconfirmed) until progression according to RECIST (version 1.0) or death.~Duration is expressed in Median number of days."|Up to 48 weeks|FAS (RECIST evaluable set)|||days||Inter-Quartile Range|Median
1470218|NCT00706628|Secondary|Overall Objective Response by RECIST Criteria (Version 1.0) (Complete Response [CR] or Partial Response [PR]) for Patients With Measurable Disease at 12, 24, 36 and 48 Weeks|Objective response is defined as a Complete or Partial response Complete response [CR] for Target lesions: Disappearance of all target lesions. Complete response [CR] for Non- target lesions: Disappearance of all non-target lesions and normalization of tumour marker level Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|12, 24, 36 and 48 weeks|FAS (RECIST evaluable set)|||percentage of participants|||Number
1470219|NCT00706628|Secondary|RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks|RECIST (version 1.0) tumour progression rate at 12, 24, 36, and 48 weeks was calculated based on the occurrence of new lesions, or an increase in the sum of the longest lesion diameters of at least 20%.|12, 24, 36, and 48 weeks|FAS (RECIST evaluable set); RECIST evaluable set, which consisted of patients who had RECIST measurable disease at baseline.|||percentage of participants|||Number
1470220|NCT00706628|Secondary|Time to PSA Progression|"Time to PSA progression through 48 weeks was calculated as the number of days from first administration of study drug to the first time that there was an increase of 50% from the PSA nadir, provided the absolute increase was at least 5 ng/mL.~Time is expressed in median number of days."|Start of treatment until end of treatment (Up to 48 weeks)|FAS|||days||95% Confidence Interval|Median
1470221|NCT00706628|Secondary|Duration of PSA Response|"Duration of PSA response was calculated from the time of first 50% decline in PSA (compared to baseline) until the time at which there was an increase of 50% from the PSA nadir, provided that the absolute increase was at least 5 ng/mL. The increase had to be confirmed by a second consecutive measurement that was at least 50% above the nadir. If the PSA never showed a 50% increase over the nadir value, then the patient was censored at the last PSA measurement.~Duration of PSA response expressed in median number of days."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS|||days||Inter-Quartile Range|Median
1470222|NCT00706628|Secondary|Number of Patients Showing Prostate Serum Antigen (PSA) Response|"PSA response was evaluated according to the PSAWG guidelines. All patients achieving a fall in PSA of ≥50% from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria for PSA response. The confirmatory value had to be at least 50% lower than the baseline value, but could be higher than the original drop in PSA (first PSA value).~However, the confirmatory value could not be 50% higher than the first PSA value. If it was ≥50% higher than the first PSA, another sample was taken to determine if response had been achieved."|End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)|FAS|||percentage of participants|||Number
1470223|NCT00706628|Secondary|Progression Free Rate at 24 and 48 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to RECIST version 1.0"|24 weeks and 48 weeks|"Full analysis set (FAS), which consisted of all patients who received at least~1 dose of study medication and for whom progression status could be determined at 12 weeks."|||percentage of participants||95% Confidence Interval|Number
1470241|NCT00706550|Primary|Immunoglobulin G (IgG) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline||||Micrograms/ml||Full Range|Geometric Mean
1470224|NCT00706628|Primary|Progression Free Rate (PFR) at 12 Weeks|"PFR is defined as a composite endpoint for disease progression.~If patients met one of the following criteria they were counted as having progressive disease (PD):~Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria~Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)~Disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0"|12 weeks|Modified full analysis set(mFAS): Patients who received at least 1 dose of study medication and for whom progression status could be determined at 12 weeks,excluding patients who discontinued treatment before 12 weeks for reasons other than PD.|||percentage of participants||95% Confidence Interval|Number
1470225|NCT00706589|Primary|Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)|The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.|10 week|ITT (Intention-To-Treat)analysis|||units on a scale||Full Range|Mean
1470226|NCT00706589|Secondary|1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.||10 weeks|||||||
1470227|NCT00706563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAE)|An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1470228|NCT00706563|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AE)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 21-day (Day 0-20) post-vaccination period||||subjects|||Number
1470229|NCT00706563|Secondary|Number of Subjects Reporting Solicited Symptoms|"Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.~Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever"|During the 4-day (Day 0-3) post-vaccination period||||subjects|||Number
1470230|NCT00706563|Primary|Seroprotection Power|Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40|At Day 21|Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects unprotected at pre-vaccination and with available results|||subjects|||Number
1470231|NCT00706563|Primary|Serconversion Factor|Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains|At Day 21||||factor|||Number
1470232|NCT00706563|Primary|Number of Serconverted Subjects|A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4|At Day 21||||subjects|||Number
1470233|NCT00706563|Primary|Number of Seroprotected Subjects|A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40|At Day 0 and 21||||subjects|||Number
1470234|NCT00706563|Primary|Number of Subjects With HI Antibody Titer Above the Cut-off Value|The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains|At Day 0 and 21||||subjects|||Number
1470235|NCT00706563|Primary|Hemagglutination Inhibition (HI) Antibody Titer|Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains|At Day 0 and 21||||titer||95% Confidence Interval|Geometric Mean
1470236|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.|One-month post-vaccine||||Titers||Full Range|Geometric Mean
1470237|NCT00706550|Primary|Opsonophagocytic Killing Activity (OPA)|This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.|Baseline||||Titers||Full Range|Geometric Mean
1470238|NCT00706550|Primary|IgM Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine||||Micrograms/ml||Full Range|Geometric Mean
1470239|NCT00706550|Primary|Immunoglobulin M (IgM) Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.|Baseline||||Micrograms/ml||Full Range|Geometric Mean
1470240|NCT00706550|Primary|IgG Levels|Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.|One-month post-vaccine||||Micrograms/ml||Full Range|Geometric Mean
1470242|NCT00706485|Secondary|Marginal Failure.|Marginal failure is defined as appearance of tumor growth at the margin of dural plaque.|up to 10 years|Study was closed without analysis of anatomic sites of failure. No data were collected for this outcome.||||||
1470243|NCT00706485|Secondary|Number of Participants With Local Control|Local failure is defined as: extension of the tumor margin[s] in any direction at least 5 mm beyond that present on the pre-treatment imaging studies or the appearance of -tumor in tissues previously scored as sites of sub-clinical disease. Local control is absence of local failure.|at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10||||participants|||Number
1470244|NCT00706485|Primary|Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use||At time of procedure||||participants|||Number
1470245|NCT00706446|Secondary|Asthma-related Quality of Life||1 year|Data was not collected for secondary outcomes due to study termination.||||||
1470246|NCT00706446|Secondary|Symptom-free Days||1 year|Data was not collected for secondary outcomes due to study termination.||||||
1470247|NCT00706446|Secondary|Exhaled NO (Nitric Oxide)||1 year|Data was not collected for secondary outcomes due to study termination.||||||
1470248|NCT00706446|Secondary|FEV1 (Forced Expiratory Volume)||1 year|Data was not collected for secondary outcomes due to study termination||||||
1470249|NCT00706446|Primary|Number of Patients With Asthma Exacerbation||1 year||||Participants|||Count of Participants
1470250|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 10 (6 Weeks after Final PDT)|ITT observed|||particpants|||Number
1470251|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)|﻿OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
1470252|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 7 (Week 9)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 7 (Week 9)|ITT observed|||participants|||Number
1470253|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 5 (Week 6)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 5 (Week 6)|ITT observed|||participant|||Number
1470254|NCT00706433|Secondary|Oozing/Vesiculation/Crusting at Visit 3 (Week 3)|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|Visit 3 (Week 3)|ITT observed|||participants|||Number
1470255|NCT00706433|Secondary|Oozing/Vesiculation/Crusting 48 Hours After PDT #1|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal – a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild – two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate – more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe – any degree of oozing, vesiculation or crusting greater than (3) above|48 hours after PDT #1|ITT observed|||participants|||Number
1470256|NCT00706433|Secondary|Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 10 (6 Weeks after Final PDT)|ITT observed|||participants|||Number
1470257|NCT00706433|Secondary|Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
1470258|NCT00706433|Secondary|Scaling and Dryness at Visit 7 (Week 9)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 7 (Week 9)|ITT observed|||participants|||Number
1470259|NCT00706433|Secondary|Scaling and Dryness at Visit 5 (Week 6)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 5 (Week 6)|ITT observed|||participants|||Number
1470260|NCT00706433|Secondary|Scaling and Dryness at Visit 3 (Week 3)|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Visit 3 (Week 3)|ITT observed|||participants|||Number
1470261|NCT00706433|Secondary|Scaling and Dryness 48 Hours After PDT #1|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal – barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate – fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe – coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|48 hours after PDT #1|ITT observed|||participants|||Number
1470262|NCT00706433|Secondary|Stinging/Burning at Visit 10 (6 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 10 (6 Weeks after Final PDT)|ITT observed|||participants|||Number
1470263|NCT00706433|Secondary|Stinging/Burning at Visit 9 (3 Weeks After Final PDT)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 9 (3 Weeks after Final PDT)|ITT observed|||participants|||Number
1470264|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - post light treatment)|ITT observed|||participants|||Number
1470265|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - during light treatment)|ITT observed|||participants|||Number
1470266|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - prior to light treatment)|ITT observed|||participants|||Number
1470267|NCT00706433|Secondary|Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 7 (Week 9 - before study drug application)|ITT observed|||participants|||Number
1470268|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - post light treatment)|ITT observed|||participants|||Number
1470269|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - during light treatment)|ITT observed|||participants|||Number
1470270|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - prior to light treatment)|ITT observed|||participants|||Number
1470271|NCT00706433|Secondary|Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 5 (Week 6 - before study drug application)|ITT observed|||participants|||Number
1470272|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - post light treatment)|ITT observed|||participants|||Number
1470273|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - during light treatment)|ITT observed|||participants|||Number
1470274|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before light treatment)|ITT observed|||participants|||Number
1470275|NCT00706433|Secondary|Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Visit 3 (Week 3 - before study drug application)|ITT observed|||participants|||Number
1470277|NCT00706433|Secondary|Stinging/Burning at Baseline - Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - post light treatment|ITT observed|||participants|||Number
1470278|NCT00706433|Secondary|Stinging/Burning at Baseline - During Light|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - during light|ITT observed|||participants|||Number
1470279|NCT00706433|Secondary|Stinging/Burning at Baseline - Before Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate – tolerable, but causes some discomfort Grade 3 = Severe – very uncomfortable or intolerable|Baseline - before light treatment|ITT observed|||participants|||Number
1470280|NCT00706433|Secondary|Edema 6 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|6 weeks after final PDT|ITT observed|||participants|||Number
1470281|NCT00706433|Secondary|Edema 3 Weeks After Final PDT|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|3 weeks after final PDT|ITT observed|||participants|||Number
1470282|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - post light treatment)|ITT observed|||participants|||Number
1470283|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Prior to Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - prior to light treatment)|ITT observed|||participants|||Number
1470284|NCT00706433|Secondary|Edema at Visit 7 (Week 9 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 7 (Week 9 - before study drug application)|ITT observed|||participants|||Number
1470285|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - post light treatment)|ITT observed|||participants|||Number
1470286|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Pre Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - pre light treatment)|ITT observed|||participants|||Number
1470287|NCT00706433|Secondary|Edema at Visit 5 (Week 6 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 5 (Week 6 - before study drug application)|ITT observed|||participants|||Number
1470288|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Post Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - post light treatment)|ITT observed|||participants|||Number
1470289|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Light Treatment)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before light treatment)|ITT observed|||participants|||Number
1470290|NCT00706433|Secondary|Edema at Visit 3 (Week 3 - Before Study Drug Application)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Visit 3 (Week 3 - before study drug application)|ITT observed|||participants|||Number
1470359|NCT00706121|Secondary|Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||Participants|||Count of Participants
1470291|NCT00706433|Secondary|Edema 48 Hours After PDT #1|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|48 hours after PDT #1|ITT observed|||participants|||Number
1470292|NCT00706433|Secondary|Edema at Baseline - Post Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - Post Light Treatment|ITT observed|||participants|||Number
1470293|NCT00706433|Secondary|Edema at Baseline - Pre Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal – scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline - pre light treatment|ITT observed|||participants|||Number
1470294|NCT00706433|Secondary|Erythema 6 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|6 Weeks after Final PDT|ITT observed|||participants|||Number
1470295|NCT00706433|Secondary|Erythema 3 Weeks After Final PDT|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|3 Weeks after Final PDT|ITT observed|||participants|||Number
1470296|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - post light treatment)|ITT, observed|||participant|||Number
1470297|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Pre Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - pre light treatment)|ITT observed|||participants|||Number
1470298|NCT00706433|Secondary|Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 7 (Week 9 - prior to study drug application)|ITT observed|||participants|||Number
1470299|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - post light treatment)|ITT, observed|||participants|||Number
1470300|NCT00706433|Secondary|Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Weeks 6 - pre-light treatment)|ITT, observed|||participants|||Number
1470301|NCT00706433|Secondary|Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 5 (Week 6 - prior to study drug application)|ITT, observed|||participants|||Number
1470302|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Post Light Treatment)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - post light treatment)|ITT, observed|||participants|||Number
1470303|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre-light)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre-light)|ITT, observed|||participants|||Number
1470304|NCT00706433|Secondary|Erythema at Visit 3 (Week 3 - Pre Study Drug Application)|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Visit 3 (Week 3 - pre study drug application)|ITT, observed|||participants|||Number
1470305|NCT00706433|Secondary|Erythema 48 Hours After PDT #1|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|48 hours after PDT #1|ITT, observed|||participants|||Number
1470306|NCT00706433|Secondary|Erythema at Baseline - Post Light Treatment|Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline - post light treatment|ITT observed|||participants|||Number
1470307|NCT00706433|Secondary|Erythema at Baseline (Pre-light)|"After solution application, prior to light treatment~﻿ Grade 0 = None Grade 1 = Minimal – barely perceptible erythema Grade 2 = Mild – predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate – predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe – predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema"|Baseline (pre-light)|ITT, observed|||participants|||Number
1470308|NCT00706433|Secondary|Hypopigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed|||participants|||Number
1470309|NCT00706433|Secondary|Hypopigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed|||participants|||Number
1470310|NCT00706433|Secondary|Hypopigmentation at Visit 7 (Week 9)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed|||participants|||Number
1470311|NCT00706433|Secondary|Hypopigmentation at Visit 5 (Week 6)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed|||participants|||Number
1470312|NCT00706433|Secondary|Hypopigmentation at Visit 3 (Week 3)|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed|||participants|||Number
1470313|NCT00706433|Secondary|Hypopigmentation 48 Hours Post PDT #1|﻿ HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|48 hours post PDT #1|ITT, observed|||participants|||Number
1470314|NCT00706433|Secondary|Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 10 (6 weeks after final PDT)|ITT, observed|||participants|||Number
1483520|NCT00599924|Secondary|Cmin of Free Platinum, Total Platinum, and 5-FU||pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose|Cmin was not calculated for Free Platinum, Total Platinum, and 5-FU.||||||
1470315|NCT00706433|Secondary|Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 9 (3 weeks after final PDT)|ITT, observed|||participants|||Number
1470316|NCT00706433|Secondary|Hyperpigmentation at Visit 7 (Week 9)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 7 (Week 9)|ITT, observed|||participant|||Number
1470317|NCT00706433|Secondary|Hyperpigmentation at Visit 5 (Week 6)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 5 (Week 6)|ITT, observed|||participants|||Number
1470318|NCT00706433|Secondary|Hyperpigmentation at Visit 3 (Week 3)|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Visit 3 (Week 3)|ITT, observed|||participants|||Number
1470319|NCT00706433|Secondary|Hyperpigmentation 48 Hours After PDT #1|﻿ HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|48 hours after PDT #1|ITT, observed|||participants|||Number
1470320|NCT00706433|Secondary|Investigator Global Assessment of Acne Severity Successes|"Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.~﻿0 Clear skin with no inflam or non-inflam lesions~Almost clear; rare non-inflam lesions with no more than a few small inflam lesions~Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)~Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule~Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules"|Baesline and 6 weeks after final treatment|ITT LOCF|||participants|||Number
1470321|NCT00706433|Secondary|Change in Inflammatory Lesion Counts Relative to Baseline|change in lesion counts compared to baseline|Baseline and 6 weeks after final treatment|ITT LOCF|||change in lesion count||Standard Deviation|Median
1470322|NCT00706433|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|6 weeks after final treatment|ITT, observed|||participants|||Number
1470323|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 6 weeks after final treatment|ITT LOCF|||percent change in lesion count||Standard Deviation|Median
1470324|NCT00706433|Secondary|Percent Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT LOCF|||percent change in lesion count||Standard Deviation|Median
1470325|NCT00706433|Primary|Investigator Global Assessment of Acne Severity Successes|Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.|Baseline and 3 weeks after final treatment|ITT LOCF|||participants|||Number
1470326|NCT00706433|Primary|Change in Inflammatory Lesion Counts Relative to Baseline||Baseline and 3 weeks after final treatment|ITT analysis, LOCF|||change in lesion count||Standard Deviation|Median
1470327|NCT00706407|Primary|Number of Participants Reporting Downward/Flat/Upward Patterns as Assessed by Near Infrared Spectroscopy (NIRS) for BOO Diagnosis|The correlation of the NIRS pattern itself (independent of Qmax and PVR) to BOO. We looked at if the use of the NIRS is a comparable predictor for BOO in patients who were obstructed and those who weren't. The goal of the NIRS is to provide a non-invasive means to diagnose BOO. According to the NIRS algorithm, a downward NIRS pattern related to a higher probability of obstruction and and upward pattern relates to a higher probability of non obstruction.|Assessed at 3 and 6 months, post operatively||||participants|||Number
1470328|NCT00706355|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|Baseline until disease progression up to C2 D1|Efficacy analysis set included all enrolled participants who received the study treatment and had measurable disease at baseline.|||Percentage of participants||95% Confidence Interval|Number
1470329|NCT00706355|Secondary|Change From Baseline in Tumor Proliferation Using F-Fluoro-3'-Deoxy-3’-L-Fluorothymidine Positron Emission Tomography (FLT-PET) Imaging at Day 1 of Cycle 2|F-fluoro-3'-deoxy-3’-L-fluorothymidine positron emission tomography (FLT-PET) imaging was used to assess the tumor proliferation in RP2D cohorts. Results of the FLT-PET were scored according to the methods developed by the American College of Radiology Imaging Network (ACRIN).|Cycle 2 Day 1|Data was not analyzed due to insufficient number of participants enrolled.|||Standardized Uptake Value (SUV)||Standard Deviation|Mean
1470330|NCT00706355|Secondary|Apparent Oral Clearance (CL/F) for PF-04217903|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Liter/hr (L/hr)||Standard Deviation|Geometric Mean
1470331|NCT00706355|Secondary|Metabolite to Parent Ratio Area Under the Curve From Time Zero to End of Dosing Interval (MRAUCtau)|Molar ratio of metabolite to parent area under the plasma concentration time-curve from zero (pre-dose) to end of dosing interval (MRAUCtau).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Ratio||Standard Deviation|Mean
1470332|NCT00706355|Secondary|Accumulation Ratio (Rac) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Rac is obtained from AUCtau (Cycle 2 Day 1) divided by AUCtau (Cycle 1 Day 1). Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Ratio||Standard Deviation|Mean
1470333|NCT00706355|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval [AUC(0-tau)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the concentration-time profile from time zero to time tau (dosing interval), where tau is equal to 12 hours.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng*hr/mL||Standard Deviation|Geometric Mean
1470334|NCT00706355|Secondary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measured Concentration [AUC(0-last)] for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng*hr/mL||Standard Deviation|Geometric Mean
1470335|NCT00706355|Secondary|Pre-dose Plasma Concentration (Ctrough) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
1470336|NCT00706355|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C1 D1 and C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||hr||Full Range|Median
1470337|NCT00706355|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)|Participants did not receive 200 mg twice a day dose of study treatment for this specific measure.|0 (pre-dose), 1, 2, 4, 6, 8 and 12 hrs (just prior to evening dosing) post dose on C2 D1|The PK parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. ‘n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||ng/mL||Standard Deviation|Geometric Mean
1470338|NCT00706355|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-04217903 and PF-04217903 Metabolite (PF-04328029)||0 (pre-dose), 1, 2, 4, 6, 8 and 12 hours (hrs) (just prior to evening dosing) post dose on Cycle (C) 1 Day (D) 1 and C2 D1|The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received the study medication and had at least 1 of the PK parameters of interest. 'n’ signifies those participants evaluated for this measure at specific time point for each arm group respectively.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
1470339|NCT00706355|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLT includes Gr 2 elevated creatinine and acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable), Gr >= 3 non-hematological non-disease-related (NDR) toxicities (except alopecia, Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >= 7 days, febrile neutropenia, neutropenic infection, inability to deliver at least 80 percent of planned dose during Cycle 1 due to NDR adverse events.|Baseline up to 21 days after the start of each increased treatment dose|DLT analysis set: participants who received first cycle of study medication and did not temporarily or permanently discontinue from study medication or missed more than 3 consecutive days of PF-04217903 dosing for reasons other than DLTs within first cycle.|||Participants|||Number
1470340|NCT00706355|Primary|Recommended Phase 2 Dose (RP2D)||Baseline up to 21 days after the start of each increased treatment dose|Data was not analyzed due to insufficient number of participants enrolled.|||mg|||Number
1470360|NCT00706121|Primary|Effect of Selenium on Occurrences of Multiple (>2) Adenomas||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
1470341|NCT00706355|Primary|Maximum Tolerated Dose (MTD)|MTD: dose level at which 1 of 6 participants experienced dose-limiting toxicity (DLT) after 21 days of treatment (Cycle 1). DLT: grade (Gr) 2 elevated creatinine, acute renal failure, Gr 3 thrombocytopenia with bleeding, hypertension (if unmanageable),Gr >=3 non-hematological non-disease-related (NDR) toxicities (except alopecia,Gr 3/4 hypophosphatemia, hyperuricemia), Gr 3/4 nausea, vomiting, diarrhea, Gr 4 neutropenia, thrombocytopenia lasting for >=7 days, febrile neutropenia, neutropenic infection, inability to deliver 80 percent of planned dose during Cycle 1 due to NDR toxicities.|Baseline up to 21 days after the start of each increased treatment dose|Analysis population included all enrolled participants who received at least 1 dose of the study treatment.|||mg|||Number
1470342|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24||24 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1470343|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12||12 Months|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1470344|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24||24 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1470345|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12||12 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1470346|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6||6 Weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1470347|NCT00706342|Primary|Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2||2 weeks|Number of participants analyzed refers to the number of patients available at this timepoint for analysis.|||Participants|||Number
1470348|NCT00706329|Primary|Close Belly Button or Umbilical Hernia|The study was terminated prematurely by the IRB. Results are not shared due to data integrity concerns. These concerns are outlined in an FDA warning letter.|After surgery, subjects will be followed at intervals of one month and six months from date of surgery.|||||||
1470349|NCT00706134|Secondary|Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.|Baseline to end of study (week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mmHg||Standard Error|Least Squares Mean
1470350|NCT00706134|Secondary|Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)|Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||Ratio||Standard Error|Least Squares Mean
1470351|NCT00706134|Secondary|Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study|Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.|Baseline to end of study (Week 8)|Ambulatory blood pressure monitoring completers population: All patients that completed both ambulatory blood pressure monitoring assessments successfully.|||mmHg||Standard Error|Mean
1470352|NCT00706134|Secondary|Percentage of Patients Achieving Systolic Blood Pressure Response|Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.|Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||Percentage of participants|||Number
1470353|NCT00706134|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
1470354|NCT00706134|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)||Baseline to end of study (Week 8)|Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
1470355|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Aspirin on CRA Occurrence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||ercentage of participants in subgroup|||Number
1470356|NCT00706121|Other Pre-specified|Effect Modification of Vitamin E by Body Mass Index on CRA Occurence, Analyzed by Active Vitamin e vs. Vitamin e Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo Vitamin E.|||ercentage of participants in subgroup|||Number
1470357|NCT00706121|Other Pre-specified|Effect Modification of Selenium by Aspirin on CRA Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||ercentage of participants in subgroup|||Number
1470361|NCT00706121|Primary|Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence||From 1 year post randomization through study completion||||Participants|||Count of Participants
1470362|NCT00706121|Primary|Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo|Adenomas with diameter >=1cm or any adenoma with villous features or high-grade dysplasia|From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
1470363|NCT00706121|Primary|Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo||From 1 year post randomization through study completion|Marginal analyses were performed, with arms pooled based on active vs. placebo selenium.|||Participants|||Count of Participants
1470364|NCT00706095|Primary|Best Overall Response Per Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|throughout the study and up to 30 days after the last dose of study drug|ITT Population|||Number of Participants|||Number
1470365|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Maximum Observed Plasma Concentration (Cmax)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population|||ng/mL||Standard Deviation|Mean
1470366|NCT00706095|Primary|Mean (SD) Pharmacokinetic (PK) Parameter Area Under Concentration Time Curve From Zero to Infinity (AUC0-oo)||Pre-dose (-0.5h); post-dose at 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6 hrs, 10 hrs, 24 hrs, 48 hrs, 72hrs, 96 hrs, 120 hrs and 144 hours.|Pharmacokinetic Population|||ng*hr/mL||Standard Deviation|Mean
1470367|NCT00706030|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) of Neratinib in combination with vinorelbine in subjects with advanced solid tumors.|From Day 1 to Day 21.|Safety population of Study Part 1. Treated set including patients eligible for MTD determination.|||mg|||Number
1470368|NCT00706030|Secondary|Duration Of Response|Duration of response for subjects who had complete or partial response from first response to disease progression, death or last assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From start date of response to first PD/death, up to four years and six months.|Subjects in evaluable population who had CR or PR according to Independent Assessment.|||weeks||Full Range|Median
1470369|NCT00706030|Secondary|Progression-Free Survival|Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.|From first dose date to progression or death, up to four years and six months.|Evaluable population, independent assessment.|||weeks||95% Confidence Interval|Median
1470370|NCT00706030|Secondary|Clinical Benefit Rate|Percentage of participants with partial response (PR) or complete response (CR) or stable disease > 24 weeks by independent assessment for subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to four years and six months.|Safety population|||percentage of participants||95% Confidence Interval|Number
1470371|NCT00706030|Primary|Overall Response Rate|Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.|From first dose date to progression or last tumor assessment, up to four years and six months.|Safety population|||percentage of participants||95% Confidence Interval|Number
1470372|NCT00706004|Secondary|Serum Albumin||baseline and 4 weeks|Participants who completed the study|||g/dL||Standard Deviation|Mean
1470373|NCT00706004|Secondary|Serum Prealbumin||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1470374|NCT00706004|Secondary|Serum Vitamin E||baseline and 4 weeks|Participants who completed the study|||mg/L||Standard Deviation|Mean
1470375|NCT00706004|Secondary|Serum Vitamin A||baseline and 4 weeks|Participants who completed the study|||ug/dL||Standard Deviation|Mean
1470376|NCT00706004|Secondary|Serum Vitamin D||baseline and 4 weeks|Participants who completed the study|||ng/mL||Standard Deviation|Mean
1470377|NCT00706004|Secondary|Serum Glucose||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1470378|NCT00706004|Secondary|Serum Phosphate||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1470379|NCT00706004|Secondary|Serum Magnesium||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1470380|NCT00706004|Secondary|Serum Calcium||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1470381|NCT00706004|Secondary|ALT||baseline and 4 weeks|Participants who completed the study|||U/L||Standard Deviation|Mean
1470382|NCT00706004|Secondary|AST||baseline and 4 weeks|Participants who completed the study|||U/L||Standard Deviation|Mean
1470383|NCT00706004|Secondary|Serum Creatinine||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1470384|NCT00706004|Secondary|Serum BUN||baseline and 4 weeks|Participants who completed the study|||mg/dL||Standard Deviation|Mean
1470385|NCT00706004|Secondary|Serum Bicarb||baseline and 4 weeks|Participants who completed the study|||nmol/L||Standard Deviation|Mean
1470389|NCT00706004|Secondary|Self Reported Adverse Effects at Each Study Visit|Adverse effects are problems reported by each study subject that they experienced during this clinical trial. Examples are headache and nausea. Study subjects were asked at each visit while on study drug to report any adverse affects that had occurred since the last visit.|During entire study period|Participants who completed the study|||participants|||Number
1470390|NCT00706004|Secondary|Body Mass Index||baseline, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||kg/m^2||Standard Deviation|Mean
1470391|NCT00706004|Secondary|Bristol Stool Scale Score|The Bristol Stool Scale is a scale used to rate the consistency of stool. Stool types are accompanied by a written description. There are seven types of stool that are scored from 1 to 7. A score of 1 or 2 indicates constipation; a score of 6 or 7, diarrhea.|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||scores on a scale||Standard Deviation|Mean
1470392|NCT00706004|Secondary|Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation – Symptom (PAC-SYM) survey is a 1-page 12-item tool that measures a patient’s assessment of constipation symptoms. The items are in Likert scale format and address the severity of stool, rectal and abdominal symptoms over the past 2 weeks. Items are scored on a scale of 0 to 4, with 4 indicating the most severe. To compute the overall score, the scores of the non-missing items are summed and this is divided by the total number of non-missing items (overall score range, 0 to 4).|2-week run-in period, 2 weeks of treatment, 4 weeks of treatment|Participants who completed the study|||scores on a scale||Standard Deviation|Mean
1470393|NCT00706004|Primary|Number of Spontaneous Bowel Movements Per Week||2-week run-in period, 2-weeks of treatment, 4-weeks of treatment|Participants who completed the study|||bowel movements||Standard Deviation|Mean
1470394|NCT00705939|Secondary|Platelet Count||Platelet count at Baseline and Months 12, 24 and 36||||Platelets per cubic millimeter||Standard Deviation|Mean
1470395|NCT00705939|Secondary|Hemoglobin||Hemoglobin at Baseline and Months 12, 24 and 36||||mg/dL||Standard Deviation|Mean
1470396|NCT00705939|Other Pre-specified|Liver Volume Multiples of Normal (MN)|Liver volume measured by MRI. Normal liver volume is 25 mL/kg × body weight (kg).|Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI.|||Multiples of Normal Liver Volume||Standard Deviation|Mean
1470397|NCT00705939|Other Pre-specified|Spleen Volume Multiples of Normal (MN)|Spleen volume measured by MRI. Normal spleen volume is 2 mL/kg × body weight (kg)|Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.|||Multiples of Normal Spleen Volume||Standard Deviation|Mean
1470398|NCT00705939|Secondary|Liver Volume|Liver volume measured by MRI|Liver volume at Baseline and Months 12, 24 and 36|Intent to treat. In the Switchover group, two patients did not have MRI .|||mL||Standard Deviation|Mean
1470399|NCT00705939|Primary|Spleen Volume|Spleen volume measured by MRI|Spleen Volume at Baseline and Months 12, 24, and 36|Intent to treat. In the Switchover group, two patients did not have MRI and one patient was splenectomized.|||mL||Standard Deviation|Mean
1470400|NCT00705874|Secondary|Pharmacokinetics||End of Study|||||||
1470401|NCT00705874|Secondary|Drug Safety||Ongoing|||||||
1470402|NCT00705874|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).~DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:~Any nonhematologic toxicity > Grade 3 lasting > 3 days~Grade 4 thrombocytopenia~Grade 4 Anemia on the next scheduled dosing day~Grade 4 Neutropenia (lasting > than 5 days~Any febrile neutropenia (Grade 3 or 4))~Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity"|End of Study|Cohorts comprised 3 patients. When a patient experienced a treatment related toxicity qualifying as a DLT, up to 3 additional patients were to be enrolled at that dose. Patients who completed cycle 1 per protocol were evaluable.|||mg|||Number
1470403|NCT00705783|Secondary|Time to Discontinuation|Time to discontinuation was defined as the date of randomization to the date of study discontinuation.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
1470404|NCT00705783|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient’s condition at Baseline. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-I scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Deviation|Mean
1470405|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Negative Subscale Score|The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
1470535|NCT00704938|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module.|5 months||||Participants|||Number
1483604|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Infl Lesion count||Standard Error|Least Squares Mean
1470406|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Positive Subscale Score|The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
1470407|NCT00705783|Secondary|Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score|The severity of illness for each patient was rated using the CGI-S. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?” Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had CGI-S scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Mean
1470408|NCT00705783|Secondary|Mean Change From Baseline in the PANSS Total Score|The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who had PANSS total scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.|||Units on a scale||Standard Error|Least Squares Mean
1470409|NCT00705783|Secondary|Percentage of Patients Achieving Remission|A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients who stayed in Phase 4 for at least 6 months and had values for the specific PANSS items P1, G9, P3, P2,G5, N1, N4, and N6.|||Percentage of patients|||Number
1470410|NCT00705783|Secondary|Percentage of Responders|A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat (ITT) population: All randomized patients. Two of the 269 patients in the ITT population did not attend the Last Visit at which this Outcome Measure was assessed and were not included in the analysis.|||Percentage of patients|||Number
1470411|NCT00705783|Secondary|Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria|This is the key secondary Outcome Measure.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Percentage of patients|||Number
1470412|NCT00705783|Primary|Time to Exacerbation of Psychotic Symptoms/Impending Relapse|A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.|Baseline of the depot maintenance phase to the end of the study (Week 52)|Intent-to-treat population: All randomized patients.|||Days||95% Confidence Interval|Median
1470413|NCT00705757|Primary|The Extent of Latanoprost, Bimatoprost and Travoprost Induced Periocular Skin Hyperpigmentation Over a One Year Time Course in Newly Diagnosed Primary Open Angle and Ocular Hypertension Patients.|"Periocular skin color was measured with the Minolta Chroma Meter CR-400 and the L*a*b* system, also known as Commission Internationale de l'Eclairage. This is a well-accepted unit of measurement in which L* corresponds to brightness and a* and b* correspond to chromaticity.~Measurements were taken at baseline and 1 year. Data from each time point and each location (upper and lower eyelids or cheeks/face) were averaged, and subtracted from the baseline value for that location. Six predetermined areas on and around the upper and lower eyelid and 2 areas of the face/cheek were measured.Upper and lower eyelid values were averaged and reported as single value for each location ie;-upper eyelids, lower eyelid and cheek/face. A decrease in luminance indicates increased pigmentation at the site of measurement."|one year|Newly diagnosed glaucoma and ocular hypertension, males and females, age 30 and up, Caucasians and African Americans.|||L*a*b*||Standard Error|Mean
1470414|NCT00705718|Secondary|Secondary Endpoint - Effectiveness Evaluation|"The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System.~Stent Graft migration through 12 months~Stent Graft Patency through 12 months~All stent Graft Endoleaks at 1-month, 6-months, and 12-month~Secondary Procedures to correct Type I and type III Endoleaks through 12 months~Secondary Endovascular Procedures through 12 months~Technical Observations through 12 months"|12 months|Number of subjects enrolled in the study arm|||percentage of evaluable subjects|||Number
1470415|NCT00705718|Primary|Primary Effectiveness Endpoint (Treatment Success)|"Treatment success is defined as Technical success and the following:~Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month~Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months~Freedom from aneurysm rupture through 12 months~Freedom from conversion to surgery through 12 months~Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months~Freedom from stent graft occlusion at 12 months"|12 months|The number of evaluable subjects for ths endpoint.|||participants|||Number
1470416|NCT00705718|Primary|Primary Effectiveness Endpoint (Technical Success)|Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively.|Intra-operatively|The Technical Success of the Endurant Bifurcated arm was based on obtaining information for the first 121 evaluable subjects available in the clinical study.|||participants|||Number
1470417|NCT00705718|Secondary|Secondary Endpoints - Safety Evaluation|"The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System.~Aneurysm-Related Mortality through 12 months~All-Cause Mortality with 30 days~All-Cause Mortality within 12 months~Major Adverse Events through 12 months~Adverse Events through 12 months~Unanticipated Adverse Device Events~Serious Adverse Events (SAEs) As reported at the time of the data cut off.~Device Related Adverse Events~Procedure Related Adverse Events~Adverse Events (excluding SAEs)"|12 months|Number of subjects enrolled in the study arm|||percentage of evaluable participants|||Number
1470418|NCT00705718|Primary|Major Adverse Events Within 30 Days of Index Procedure|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days||||percentage of participants|||Number
1470419|NCT00705718|Primary|Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)|"The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events.~All-Cause Mortality~Bowel Ischemia~Myocardial Infarction~Paraplegia~Procedural Blood Loss > or equal to 1000 cc~Renal Failure~Respiratory Failure~Stroke"|30 days (Safety)|Freedom from Major Adverse Events within 30 Days of Implant|||percentage of participants|||Number
1470420|NCT00705679|Primary|Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events|This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm.|Throughout study, up to 2.5 years|All participants randomized (intention-to-treat).|||participants|||Number
1470421|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
1470422|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
1470423|NCT00705679|Primary|Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
1470424|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
1470704|NCT00703391|Primary|Aspartate Aminotransferase (AST)|AST level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1470425|NCT00705679|Primary|Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
1470426|NCT00705679|Primary|Person-years of Follow-up of Oral TDF and Oral Placebo Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
1470427|NCT00705679|Primary|Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||cases per 100 person-years||95% Confidence Interval|Number
1470428|NCT00705679|Secondary|Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product|The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure.|Throughout study, up to 2.5 years|Resistance testing was successfully completed on plasma from 301/312 HIV-1 seroconverters while on study product. 11 participants did not have a resistance result due to no stored plasma, insufficient copies of HIV-1 RNA for extraction, or PCR amplification failure.|||participants|||Number
1470429|NCT00705679|Primary|Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB).|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||participants|||Number
1470430|NCT00705679|Primary|Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms|Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up.|For up to 30 months of follow-up|All participants randomized except for those with no follow-up HIV testing or those determined to be HIV-positive at the time of randomization by PCR testing of plasma samples stored at the enrollment visit.|||person-years|||Number
1470431|NCT00705666|Primary|The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).||Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.|For the 48 week treatment period, the analysis did not separate Genotype 1 (G1) from Genotype 4 (G4) or others. Of the 789 participants, 8 were excluded from analysis (3 for lack of data; 5 because they were untreated).|||Participants|||Number
1470432|NCT00705653|Primary|Maximum Tolerated Dose (MTD)|"The MTD was defined as the dose below one-third of at least 6 subjects (e.g., 2/6, 3/9, 4/12) experienced a Dose-limiting toxicity (DLT).~Dose-limiting toxicities (DLTs) used to determine the MTD had to occur during cycle 1 of treatment and had to be considered related to PG-11047."|The MTD had to occur during cycle 1 of treatment||||mg|||Number
1470433|NCT00705653|Secondary|Preliminary Efficacy|As per RECIST Criteria (V 1.0) by radiologic evaluations: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) >= 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|For the purposes of this study, patients were reevaluated radiologically every 8 weeks. In addition to a baseline scan, confirmatory scans were obtained 6-8 weeks following initial documentation of an objective response, when appropriate.|Patients with non-missing overall response|||percentage (of participants)|||Number
1470434|NCT00705614|Secondary|Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months|The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with surgical procedure data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Surgical Procedures|||Number
1470435|NCT00705614|Secondary|Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay duration data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Days||Standard Deviation|Mean
1470705|NCT00703391|Primary|Alanine Aminotransferase (ALT)|ALT level greater than 3 times the upper limit of normal|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||Participants|||Number
1470436|NCT00705614|Secondary|Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months|The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with hospital stay data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Hospital Stays||Standard Deviation|Mean
1470437|NCT00705614|Secondary|Number of Participants With a Draining Fistula By Study Visit|The number of participants with a draining fistula was evaluated at each study visit.|Up to 5 Years|The population consisted of all enrolled participants with fistula status data. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470438|NCT00705614|Secondary|Work/Daily Activity Status Score By Study Visit|The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.|Up to 5 Years|The population consisted of all participants with a work/daily activity status score at baseline and each study visit. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
1470439|NCT00705614|Secondary|The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit|The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.|Up to 5 Years|The population consisted of all enrolled participants with a Harvey-Bradshaw Index of Crohn's Disease score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
1470440|NCT00705614|Secondary|Participant Assessment of Overall Health Status By Study Visit|The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.|Up to 5 Years|The population consisted of all enrolled participants with a Participant Assessment of Overall Health Index score at baseline and each time point. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Score on a Scale||Standard Deviation|Mean
1470441|NCT00705614|Primary|Number of Participants With Lymphoproliferative Disorders/Malignancies|The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470442|NCT00705614|Primary|Number of Participants With Hematologic Conditions|The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470443|NCT00705614|Primary|Number of Participants With Demyelinating Neurological Disorders|The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470444|NCT00705614|Primary|Number of Participants With New or Worsening Congestive Heart Failure|The number of participants with new or worsening congestive heart failure was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470445|NCT00705614|Primary|Number of Participant Fatalities|The number of participant fatalities was evaluated throughout the study.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470446|NCT00705614|Primary|Number of Participants With Infusion-Related Reactions/Hypersensitivity|The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470447|NCT00705614|Primary|Number of Participants With Serious Infections|The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.|Up to 5 Years|The population consisted of all enrolled participants. The Standard Therapy group was assessed only as long as they were on Standard Therapy without Remicade and the Switched group was assessed starting at the time of the switch to Remicade.|||Participants|||Number
1470448|NCT00705575|Secondary|Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.|||Percentage|||Number
1470449|NCT00705575|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 12|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 or Week 12 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1470450|NCT00705575|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to Week 8|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 8 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1470451|NCT00705575|Primary|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)|At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.|Baseline to end of study (Week 12)|Full analysis set (FAS): All randomized patients. For each patient, the last post-baseline measurement during the double-blind period was carried forward. n = number of patients with non-missing Week 12 measurement or last observation carried forward (LOCF) value.|||mm Hg||Standard Error|Least Squares Mean
1470452|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}])|The area under glucose infusion rate curve from minutes (min) 0 to 360 after injection (AUC[GIR{0-360}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 360 during the clamp. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[360]) data.|||Grams per kilogram||Standard Deviation|Mean
1470453|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}])|The area the glucose infusion rate curve from minutes (min) 0 to 240 after injection (AUC[GIR{0-240}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 240 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose up to 240 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[240]) data.|||Grams per kilogram||Standard Deviation|Mean
1470454|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 180 after injection (AUC[GIR{0-180}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 180 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 180 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[180]) data.|||Grams per kilogram||Standard Deviation|Mean
1471514|NCT00697515|Secondary|Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase||Baseline and 7, 14, 21 and 28 days|Safety Population (SP) defined as all subjects who received at least one dose of study medication.|||mmHg||Standard Deviation|Mean
1470455|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}])|The area under the glucose infusion rate curve from minutes 0 to 120 after injection (AUC[GIR{0-120}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 120 during the clamp. Means were calculated using analysis of variance with fixed effects of participant, sequence within participant, treatment, and period.|Predose and up to 120 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-120]) data.|||Grams per kilogram||Standard Deviation|Mean
1470456|NCT00705536|Secondary|Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}])|The area under the curve for the glucose infusion rate from minutes (min) 0 to 60 after injection (AUC[GIR{0-60}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment and every 3 min from min 0 through 60 during the clamp procedure. Means were calculated using analysis of variance with fixed of participant, sequence within participant, treatment, and period.|Predose and up to 60 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-60]) data.|||Grams per kilogram||Standard Deviation|Mean
1470457|NCT00705536|Secondary|Maximum Glucose Infusion Rate (GIR[Max])|Maximum glucose infusion rate (GIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable GIR(max) data.|||Milligrams per kilogram per minute||Standard Deviation|Mean
1470458|NCT00705536|Primary|Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone)|"Relative bioavailability was determined by dividing the baseline-corrected geometric mean of the area under the curve (AUC) for insulin (ins) (Humalog or Humulin-R) with recombinant human hyaluronidase PH20 (rHuPH20) by the baseline-corrected geometric mean of the AUC for insulin alone (AUC[insulin+rHuPH20]/AUC[insulin]).~Bioavailability values for participants who received Humalog or Humulin-R and rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog + rHuPH20 or Humulin-R + rHuPH20 with evaluable relative bioavailability (AUC[insulin+rHuPH20]/AUC[insulin alone]) data.|||Ratio of AUC(ins+rHuPH20)/AUC(ins alone)||Standard Deviation|Mean
1470459|NCT00705536|Primary|Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20])|Area under the concentration-time curve from time 0 to time to reach maximum concentration (tmax) for serum insulin (Humalog or Humulin-R) with recombinant human hyaluronidase (rHuPH20) (AUC[0-tmaxPH20]) for participants who received Humalog or Humulin-R and with rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment and every 3 min from min 0 through 48 for Stage 1 and, and every 3 min from min 0 through 68 for Stage 2 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 48 minutes postdose during Stage 1, or up to 68 minutes postdose during Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-tmaxPH20) data.|||Picomoles per liter times minutes||Standard Deviation|Mean
1470460|NCT00705536|Primary|Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t'])|Area under the serum concentration-time curve from time zero to the time required to reach endogenous plasma glucose levels (AUC[0-t']) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-t') data.|||Picomoles per liter times minutes||Standard Deviation|Mean
1470461|NCT00705536|Secondary|Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%])|"Time to late half-maximal effect for glucose infusion rate (tGIR[late50%]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.~Because the study was only 360 minutes in duration, there was not sufficient time for regular human insulin to show an effect and therefore tGIR(late50%) could not be calculated for participants receiving Humulin-R alone."|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, or Humulin-R + rHuPH20 with evaluable tGIR(late50%) data.|||Minutes||Standard Deviation|Mean
1470462|NCT00705536|Secondary|Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%])|Time to early half-maximal effect for glucose infusion rate (tGIR[early50%]) for participants who were randomized to Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(early50%) data.|||Minutes||Standard Deviation|Mean
1470463|NCT00705536|Secondary|Time to Maximum Glucose Infusion Rate (tGIR[Max])|Time to maximal effect for glucose infusion rate (tGIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained every 3 minutes during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(max) data.|||Minutes||Standard Deviation|Mean
1470464|NCT00705536|Primary|Maximum Serum Insulin Concentration (Cmax)|Maximum serum insulin concentration (Cmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable Cmax data.|||Picomoles per liter||Standard Deviation|Mean
1470465|NCT00705536|Primary|Time to Maximum Serum Insulin Concentration (Tmax)|Time to maximum serum insulin concentration (tmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period.|Predose and up to 360 minutes postdose during Stage 1 or Stage 2|Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tmax data.|||Minutes||Standard Deviation|Mean
1470466|NCT00705523|Secondary|Addiction Severity Index (ASI) Alcohol Composite Score at End of Study.|The Addiction Severity Index (ASI) is a semistructured interview that measures the severity of addiction in 25 questions concerning seven problem areas: medical problems, employment problems, drug use, alcohol use, family and social problems, criminality, and psychiatric problems. Each problem area is measured as its own Compsite Score. Each Composite Score total ranges between 0 (no endorsement of any problems) and 1 (maximal endorsement of all problems). Higher scores (i.e., those closer to 1) on each Composite Score indicate more difficulty/lower functioning in that area, while lower scores (i.e., those closer to 0) indicate higher functioning/less difficulty in that area. As such, the Addiction Severity Index (ASI) Alcohol Composite Total Score must fall between 0 and 1, and scores closer to 1 suggest continued problem drinking.|12 weeks of treatment, with a follow-up one month after treatment||||alcohol composite score||Standard Deviation|Mean
1470467|NCT00705523|Primary|Rate of Heavy Drinking Days Per Week.|Rate of heavy drinking days per week (defined as five drinks per day for men, four drinks per day for women) as determined by self-report on the time-line follow-back (TLFB).|12 weeks of treatment and one month follow-up||||rate of heavy drinking days per week||Standard Deviation|Median
1470468|NCT00705484|Primary|Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories|The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities.|Up to 5 years.|All enrolled participants. The Remicade and Standard Therapy Groups are the number of participants who enrolled at the start of the study (N=2239). The Switched to Remicade group are the subset of participants in the Standard Therapy Group, who switched to Remicade.|||Percentage of participants|||Number
1470469|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR|"Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 4, 8, 12, 16, 20|Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.|||Participants|||Number
1470536|NCT00704938|Primary|Clinical Response (Complete Response + Partial Response)|Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.|5 months||||Participants|||Number
1470470|NCT00705432|Secondary|Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)|"Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."|At Treatment Week 2, 4, 8, 12, 16, or 20|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Participants|||Number
1470471|NCT00705432|Secondary|Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL."|At FW 12 and at 72 weeks after randomization|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Participants|||Number
1470472|NCT00705432|Secondary|Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.~HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR."|At FW 24|Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.|||Percentage of participants|||Number
1470473|NCT00705432|Primary|Sustained Virologic Response (SVR) Rate|"Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.~HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.~If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR."|At Follow-up Week (FW) 24|Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).|||Percentage of participants|||Number
1470474|NCT00705406|Other Pre-specified|Change in Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50 and Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).|||Fold Change from Baseline||Standard Error|Mean
1470475|NCT00705406|Other Pre-specified|Baseline Influenza Virus B Susceptibility to Neuraminidase Inhibitors (Mean Baseline IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. Baseline was defined as the last non-missing value occuring prior to the initiation of study drug.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected (ITTI) population that included all subjects who were randomized, received study drug, and had confirmed influenza B infection by culture or PCR. The n reported is the number of participants who had baseline susceptibility values to zanamivir, oseltamivir, and peramivir.|||nM||Standard Error|Mean
1470476|NCT00705406|Other Pre-specified|Change in Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Fold Change From Baseline in IC50)|Change from Baseline to last positive value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates. These analyses were presented separately by treatment group and viral subtype.|Baseline and up to 14 days|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N is for fold change (participants who had baseline and last positive susceptibility values to zanamivir, oseltamivir, and peramivir).|||Fold Change from Baseline||Standard Error|Mean
1470477|NCT00705406|Other Pre-specified|Baseline Influenza Virus A (H1N1) Susceptibility to Neuraminidase Inhibitors (Mean IC50)|Baseline value of influenza virus susceptibility to neuraminidase inhibitors was assessed using virology laboratory tests. Virology laboratory tests included phenotypic characterizations of influenza virus recovered (hemagglutinin and neuraminidase) and viral susceptibility to zanamivir, oseltamivir, and peramivir, as well as genotyping of virus isolates.|Baseline|A subgroup of the Intent-to-Treat Infected Influenza A (ITTI-A) population that included all subjects who were randomized, received study drug, and had confirmed influenza A (H1N1) infection by culture or PCR. N was 113 for zanamivir susceptibility in the Placebo group.|||nM||Standard Error|Mean
1470478|NCT00705406|Other Pre-specified|Incidence of Influenza-related Complications|Study personnel were provided with an IRC checklist in the CRF to evaluate the subject for the presence of clinical signs and/or symptoms of the following IRCs: sinusitis, otitis, bronchitis, and pneumonia. Subjects with clinical signs and/or symptoms consistent with these conditions at Screening were not eligible for enrollment in this study.|14 days|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||participants|||Number
1470537|NCT00704912|Secondary|Prevalence of Metabolic Syndrome||Baseline, 4 months||||participants|||Number
1470479|NCT00705406|Other Pre-specified|Time to Resolution of Fever|Time to resolution of fever was defined as the number of hours from initiation of study drug until temperature was less than 37.2 °C (99.0 °F) and no antipyretic medication had been taken for at least 12 hours.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||hours||95% Confidence Interval|Median
1470480|NCT00705406|Other Pre-specified|Subject’s Severity of Illness (Score*Hours)|"A subject’s severity of illness (area under the symptom score curve, as measured in score-hours) was assessed using available symptom score data until the time of alleviation of symptoms.The score-hours were calculated as the product of the daily symptom score times the hours to alleviation. All available data until time of alleviation were utilized.~The daily symptom score was defined as the sum of the 7 symptoms of influenza recorded by the subject in the diary each day (cough; sore throat; nasal congestion; myalgia [aches and pains]; headache; feverishness; and fatigue), each graded on a 4-point severity scale [0, absent; 1, mild; 2, moderate; 3, severe]); for the composite score, individual scores were summed, with a range from 0 to 21."|Information collected predose on Day 1 and then once daily through Day 14|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||score*hours||Full Range|Median
1470481|NCT00705406|Secondary|Change in Influenza Virus Shedding|Changes from Baseline in log10 TCID50/mL through Days 3, 4, and 9 were presented by treatment group for subjects with positive viral titers at Baseline (log10 TCID50/mL >0.5).|Baseline and Days 3, 4, 9|The Intent-to-Treat Infected Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A infection by culture or PCR.|||log10(TCID50/mL)||95% Confidence Interval|Median
1470482|NCT00705406|Primary|Time to Alleviation of Symptoms (Kaplan-Meier Estimate)|The primary efficacy endpoint was the time to alleviation of symptoms calculated as the number of hours from initiation of study drug until the start of the time period in which all 7 symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 hours - 10%) hours. Subjects with missing diary data were excluded and those who did not experience alleviation of symptoms were censored at the last observed symptom assessment.|Information collected twice daily beginning predose on Day 1 and through Day 9, then once daily through Day 14|The Intent-to-Treat Infected with Influenza A (ITTI-A) population included all subjects who were randomized, received study drug, and had confirmed influenza A by culture or PCR.|||hours||95% Confidence Interval|Median
1470483|NCT00705367|Secondary|Long-term Period: Number of Participants With Abatacept-specific Antibodies|Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.|Day15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of abatacept and had an immunogenicity test result.|||Participants|||Number
1470484|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): >2*ULN, or if preRX>ULN, use >3*preRX; AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX; ALT (U/L): >3X*ULN, or if preRX>ULN, use >4*preRX; GGT (/L): >*ULN, or if preRX>ULN, use >3*preRX; bilirubin (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX; BUN (mg/dL):>2*preRX; sodium: <.95*LLN, >1.05*ULN, <.95* preRX if <LLN preRX, >1.05*preRX if >ULN preRX; >ULN if <LLN preRX, <LLN if >ULN preRX; potassium: chloride: calcium: phosphorous:|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1470485|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): <65 or >220. Glucose, fasting(mg/dL): <0.8*LLN or >1.5* ULN; if preRX<LLN, use <0.8*preRX or >ULN; if preRX>ULN, use >2.0*preRX or <LLN. Protein, total (g/dL): <0.9*LLN or >1.1*ULN; if preRX<LLN, use 0.9*preRX or >ULN if preRX >ULN, use 1.1*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX<LLN use <0.75*preRX. Uric acid (mg/dL): >1.5*ULN; if preRX>ULN use >2*preRX. Protein, urine: if missing preRX, use>=2; if >=4; if preRX=0 or 0.5, use >=2; if preRX=1, use >=3, or if preRX=2 or 3, use >= 4. Glucose, urine: if preRX missing, use >=2; if >=4, or if preRX=0 or 0.5 use >=2,or if preRX=1, use >=3, or if preRX=2 or 3 use >=4. Blood, urine: if preRX missing, use>= 2, or if >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3; if preRX=2 or 3 use >=4. WBC, urine (hpf): if missing preRX, use>= 2, or if >= 4, or if preRX =0 or 0.5 use >=2, or if preRX=1 use >=3, or if preRX=2 or 3 use >=4.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1470486|NCT00705367|Secondary|Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): >3g/dL drop from preRX; hematocrit (%): <0.75*preRX; erythrocytes (*10^6 c/uL): <0.75*preRX; platelet count (*10^9 c/L): <0.67*LLN or >1.5*ULN, or <100,000/mm^3 or if preRX<LLN, use <0.5*preRX and <100,000/mm^3; leukocytes (*10^3 c/uL): <0.75*LLN, >1.25*ULN, <0.8*preRX if preRX <LLN or >1.2*preRX if preRX >ULN; >ULN if preRX <LLN, <LLN if >ULN preRX; neutrophils+bands (*10^3 c/uL): if value <1.00*10^3 c/uL; lymphocytes (*10^3 c/uL): if value <0.750*10^3 c/uL or if value >7.50*10^3 c/uL; monocytes (*10^3 c/uL): if value >2000/mm^3; basophils (*10^3 c/uL): if value >400/mm^3; eosinophils (*10^3 c/uL): if value> 0.750*10^3 c/uL|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1470487|NCT00705367|Primary|Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities|Laboratory tests consisted of complete blood count, chemistry, and urinalysis.|Screening and Days 1 and 2|All participants who received at least 1 dose of study drug|||Participants|||Number
1470488|NCT00705367|Primary|Short-term Period: Mean Temperature|Vital sign measurements are summarized without regard to position (sitting, standing, supine).|Day 1 predose and postdose and Day 2|All participants who received at least 1 dose of study medication.|||Degrees Celsius||Standard Deviation|Mean
1470489|NCT00705367|Secondary|Maximum (Cmax) Plasma Concentration of Abatacept|Cmax is a drug's maximum, or peak, concentration observed after its administration.|Postdosing Day 1|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
1470493|NCT00705367|Primary|Short-term Period: Number of Adverse Events (AEs) Related to Study Drug|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.|||Events|||Number
1470494|NCT00705367|Secondary|Minimum (Cmin) Plasma Concentration of Abatacept|Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.|Days 15, 29, 85, 169, 253 and 337|All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.|||ug/mL||Standard Deviation|Mean
1470495|NCT00705367|Secondary|Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs|AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Days 15 to 56 days post last dose of the long-term period|All participants who received at least 1 infusion of abatacept during the open-label long-term extension period of the study.|||Participants|||Number
1470496|NCT00705367|Primary|Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|From Day 1 of double-blind period to 1st dose of long-term period|All participants who received at least 1 dose of study medication.|||Participants|||Number
1470497|NCT00705341|Secondary|Predictive Value of Methacholine Challenge Test for Phase 1|Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls|one time||||% predictive value||95% Confidence Interval|Number
1470498|NCT00705341|Primary|Methacholine Challenge Test Result for Phase 2|Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks|weeks 0, 4|There was a significant period effect in the percentage change in post diluent baseline (PC20) for high- and low-dose depending upon the order in which the doses were administered. In order to remove the effect of the order, we compared the high- and low-dose MCT results exclusively during the first cross over.|||mg/ml||Full Range|Geometric Mean
1470499|NCT00705289|Primary|Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.|At Baseline|All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.|||Score on a scale||Standard Deviation|Mean
1470500|NCT00705289|Primary|Baseline Raw DAS28 by Country of Residence|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.|At Baseline||||Score on a scale||Standard Deviation|Mean
1470501|NCT00705289|Primary|Baseline Raw DAS28 by Gender|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.|||Score on a scale||Standard Deviation|Mean
1470502|NCT00705289|Primary|Baseline Raw DAS28 by Time Since Diagnosis|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.|At Baseline||||Score on a scale||Standard Deviation|Mean
1470503|NCT00705289|Primary|Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age|Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.|At Baseline|Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.|||Score on a scale||Standard Deviation|Mean
1470504|NCT00705263|Primary|Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.|Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.|After 4 weeks of treatment.|Patients with chronic hepatitis C treated with PegIntron pen plus Rebetol|||Satisfied Participants|||Number
1470538|NCT00704912|Secondary|Change in Weight|Change from baseline to end of the 4-month intervention.|Baseline, 4 months||||kg||95% Confidence Interval|Least Squares Mean
1470539|NCT00704912|Secondary|Ovulation Rate||Up to 4 months||||total number of ovulations|Clomiphene Treatment Cycles||Number
1470505|NCT00705250|Primary|Determine the Overall Response Rate (RR) to Bendamustine HCL in Patients With Relapsed and Primary Refractory HL.|The percentage of evaluable participants who achieved either a complete response (CR) or partial response (PR). CR Disappearance of all evidence of disease. (a) FDGavid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT. PR Regression of measurable disease and no new sites. > or = to 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT.|up to 3 years||||percentage of evaluable participants|||Number
1470506|NCT00705224|Secondary|Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline|Early Virological response (EVR) was assessed at 12 weeks after treatment start (Visit 2) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who achieved EVR. EVR was defined as a substantial (greater than 2 log10) decrease in viral load (measured as International Units/milliliter) and/or negative Polymerase chain reaction (PCR)-based viral load qualitative result as assessed at visit 2 of the study.|Week 12 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 210 participants demonstrated early virological response (N=158 and N=50). 2 participants of the 210 had missing values.|||Percentage of Participants|||Number
1470507|NCT00705224|Secondary|Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|Virological relapse (VR) was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the percentage of participants who demonstrated VR. VR was defined as undetectable plasma HCV-RNA (RFT +) at end of treatment (Visit 3- considered Week 24 or Week 48 after treatment start depending on treatment duration), but lost RFT (considered sustained non-Responders) at end of study (Visit 4- considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively).|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 29 participants demonstrated virological relapse (N=18 and N=11) and were therefore included in this analysis.|||Percentage of Participants|||Number
1470508|NCT00705224|Secondary|Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline|Response following treatment (RFT) was assessed at the end of treatment (Visit 3) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as HOMA-IR >3) to investigate the presence or absence of RFT. RFT was defined as undetectable plasma HCV-RNA at end of treatment. Visit 3 was considered Week 24 or Week 48 after treatment start depending on treatment duration.|Week 24 or 48 after treatment start|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 208 achieved RFT (N=156 and N=51) and were therefore included in this analysis. 1 participant of the 208 had missing values.|||Percentage of Participants|||Number
1470509|NCT00705224|Secondary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline|SVR was assessed at the end of the study (Visit 4) by HCV genotype (I, II, III, or other) and presence of insulin-resistance at baseline (defined as Homeostasis model assessment - of insulin-resistance [HOMA-IR] >3) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis (N=223) included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study. Of the 223 participants in this population, 181 achieved SVR (N=140 and N=40) and were therefore included in this analysis. 1 participant of the 181 had missing values.|||Percentage of Participants|||Number
1470510|NCT00705224|Primary|Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study|Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.|24 weeks following completion of 24 or 48 weeks of therapy|Completer set for the primary analysis included all participants who were administered at least one dose of the study treatment and provided the SVR data at end of study.|||Percentage of Participants||95% Confidence Interval|Number
1470511|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3|Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 7|Study eye ITT population, subjects with non-missing data|||Score on a scale||Standard Deviation|Mean
1470512|NCT00705159|Secondary|Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2|Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to Day 3|Study eye, ITT population, non-missing data|||Score on a scale||Standard Deviation|Mean
1470513|NCT00705159|Primary|Change From Baseline in the Total Blepharoconjunctivitis Grade.|Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.|Baseline to 15 days|Study eye, ITT Population, Non-missing data|||Score on a scale||Standard Deviation|Mean
1470514|NCT00705146|Secondary|Pain|AUSCAN 3.1 pain subscale. Possible score range is 0 to 50. Lower scores indicate less pain. Change scores are reported (baseline to 4 weeks splint wear) for each of the two splints.|4 weeks|Pooled all participants for the phase they wore the hybrid, then comfort cool splints, respectively. Mean change scores are reported|||units on a scale||95% Confidence Interval|Mean
1470515|NCT00705146|Primary|Hand Function|Hand Function was measured with the Australian Canadian Osteoarthritis Hand Index 3.1 (AUSCAN). The AUSCAN is a self-report tool with 15 questions in 3 subscales: pain, function, joint stiffness, and uses an 11-point (0-10) numerical rating scale. The AUSCAN function subscale has 9 items regarding level of difficulty in performing daily tasks such as opening a jar, turning a doorknob, wringing out a washcloth. Possible scores range from 0 to 90. Mean change scores are reported (baseline compared to 4 weeks splint use). Higher scores indicate worse function.|4 weeks|Pooled participants from both arms from the phase they wore the hybrid splint, then from the phase they wore the comfort cool splint. Mean change scores are reported.|||units on a scale||95% Confidence Interval|Mean
1470516|NCT00705107|Secondary|Average Length of Treatment.||Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.||||weeks||Standard Deviation|Mean
1470517|NCT00705107|Primary|Number of Subjects Who Completed Treatment.||Assessed at the end of the 48-week treatment.|All participants|||Participants|||Number
1470518|NCT00705081|Primary|Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy|Achievement of LDL-C target levels as determined by physician|4-6 weeks after the first visit|All patients enrolled|||Participants|||Number
1470519|NCT00705081|Primary|Intensity of Adverse Events Reported|Intensity of adverse events reported after co-administration therapy|4-6 weeks after the first visit|All participants enrolled|||Participants|||Number
1470520|NCT00705081|Primary|Number of Participants Reporting Adverse Events|Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)|4-6 weeks after the first visit|All participants enrolled|||Participants|||Number
1470521|NCT00705016|Secondary|Safety - Number of Participants Experiencing Any Adverse Event|Please refer to Adverse Events section for details of individual serious adverse events and other adverse events|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Safety population included all participants who were administered any dose of the trial medication, that is, cilengitide, cisplatin, 5-FU, or cetuximab.|||participants|||Number
1470522|NCT00705016|Secondary|Duration of Response|Duration of response is defined as the time from the first assessment of CR or PR until the date of the first occurrence of progressive disease (PD), or until the date of death.|Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1470523|NCT00705016|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from randomization to date of the first occurrence of; progression, discontinuation of treatment due to progression or adverse event, start of new anticancer therapy, withdrawal of consent, or death (within 84 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1470524|NCT00705016|Secondary|Disease Control Rate|The disease control rate is defined as the percentage of participants having achieved confirmed CR, PR or stable disease (SD) as best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
1470525|NCT00705016|Secondary|Best Overall Response (BOR) Rate|The BOR rate is defined as the percentage of the participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response according to radiological assessments (based on RECIST Version 1.0).|Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||percentage of participants||95% Confidence Interval|Number
1470526|NCT00705016|Secondary|Overall Survival (OS) Time|The OS time is defined as the time from randomization to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.|Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|ITT population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1470527|NCT00705016|Primary|Progression-free Survival (PFS) Time: Investigator Read|The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors [RECIST] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.|Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)|Intention-to-treat (ITT) population included all participants who were randomized to trial treatment.|||months||95% Confidence Interval|Median
1470540|NCT00704912|Primary|Live Birth Rate||Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.||||participants|||Number
1470568|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.|The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.|Week 48|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
1470528|NCT00705003|Secondary|The Change From Baseline on the HAM-A at Week 6|"The 14-item HAM-A scale rates the patient’s level of anxiety based on feelings of anxiousness, tension, and depression; any phobias, sleep disturbance, or difficulty in concentrating; the presence of genitourinary, cardiovascular, respiratory, autonomic or somatic symptoms; and the interviewer’s assessment of the patient’s appearance and behavior during the interview. Each item is to be scored on a 5 point scale with 0 reflecting no symptoms and 4 reflecting symptoms of maximum symptom severity (Hamilton 1960).~The items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 56 units on a scale, where higher scores indicate more severe anxiety. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement."|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1470529|NCT00705003|Secondary|The Change From Baseline in the Quick Inventory of Depressive Symptomatology – 16 Item Self-Report (QIDS-SR16) at Week 6|"The QIDS-SR16 is a 16 question, patient rated scale that assesses the 9 Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision criterion diagnostic symptom domains including sad mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease or increase in appetite or weight, & psychomotor agitation or retardation. Each item is measured on a scale of 0 to 3. To find total score, you enter:~highest score from items 1-4 (Sleep Items)~item 5 score~highest score from items 6-9 (appetite/weight)~item 10 score~item 11 score~item 12 score~item 13 score~item 14 score~highest score from items 15-16 (psychomotor) These 9 scores are summed to find total score. Total minimum score is 0 units on a scale & total maximum score is 27 units, where higher scores indicate more severe depression. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement"|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1470530|NCT00705003|Secondary|The Change From Baseline in the IDS-C30 at Week 6|The Inventory of Depressive Symptomatology is a 30-item scale that assesses criteria including mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep, decrease/increase in appetite or weight, psychomotor agitation or retardation, diurnal mood variation, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. Items are scored on a 4 point scale with 0 reflecting no symptoms and 3 reflecting symptoms of maximum severity. The total score is calculated by summing the scores from 28 of the 30 items. Only one of items 11 or 12, and only one of items 13 or 14 are scored. The minimum score is 0 and the maximum score is 84. A score of 84 indicates maximum severity of depressive symptoms. Change from baseline is calculated as the baseline score minus the post-baseline score. A positive change indicates improvement.|Week 0 and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1470531|NCT00705003|Secondary|The Change From Baseline in the CGI-S at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). The CGI-S is a sub-scale of the Clinical Global Impression. The Investigator was asked: “Considering your total clinical experience with patients with this particular population, please assign a rating to how mentally ill the subject is at this time.”~Possible responses include the following:~0: Not Assessed~Normal, not ill at all~Borderline mentally ill~Mildly ill~Moderately ill~Markedly ill~Severely ill~Among the most extremely ill patients. The change from baseline CGI-S score was calculated as the baseline CGI-S score minus the post-baseline CGI-S score, such that a positive change indicated an improvement from baseline."|Baseline and Week 6|Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
1470532|NCT00705003|Primary|The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6|"Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient’s clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S)~The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to “Rate the patient’s total improvement whether or not, in your judgment, it is due entirely to drug treatment.” The Investigator was asked “Compared to the patient’s condition at the Baseline visit, please assign a rating to how much the patient changed.” Responses for the CGI-I evaluation included the following categories:~0: Not Assessed~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Week 6|142 subjects were enrolled and randomized in the study. 8 of these subjects were randomized but never received study drug. Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug.|||units on a scale||Standard Error|Mean
1470533|NCT00704964|Primary|Number of Participants With Adherence to Therapy According to Physician Approximation|Adherence was based on physiciant's clinical judgment.|Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3||||Participants|||Number
1470534|NCT00704964|Primary|Number of Participants With Biometrical Adherence to Therapy|Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.|Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3||||Participants|||Number
1470541|NCT00704847|Primary|Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index|WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||Units on a scale||Standard Deviation|Mean
1470542|NCT00704847|Secondary|• Bone & Cartilage Metabolism Biochemical Marker Change. • Questionnaires to Assess Function, Stiffness, Pain, Physical Activity, and Quality of Life • Knee Disease Progression Assessed by MRI||From baseline to 24 months|||||||
1470543|NCT00704847|Primary|Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months|The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.|Change from baseline to 24 months|The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.|||mm||Standard Deviation|Mean
1470544|NCT00704808|Primary|Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme||After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide|Intent-to-Treat population|||Months||Standard Error|Median
1470545|NCT00704769|Primary|General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments|Physicians judged the subjects as good, excellent, fair, or poor.|Minimum of 7 days after initiation of desloratadine||||Participants|||Number
1470546|NCT00704769|Primary|Adverse Events|An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.|Minimum of 7 days after initiation of desloratadine||||Participants|||Number
1470547|NCT00704730|Secondary|Biochemical Response Carcinoembryonic Antigen (CEA) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CEA was determined based on percent increase or decrease from baseline. Best biochemical response over the course of treatment was determined from evaluation of each subject’s time point response data. Biochemical response: Complete Response (CR)- Decrease in tumor marker into normal range from baseline value; Partial Response (PR)- Decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD)- No more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD)- Increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE)- Missing baseline value / or baseline value is not elevated and response is not Progressive Disease (PD) / or response can not be determined due to change in assay format.|Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|For the CEA measure the analysis population differs from the Intent To Treat (ITT) population of 219 XL184 and 111 Placebo. One subject did not provide samples for CEA. The biomarker analysis was based on available samples, not on ITT.|||% of participants|||Number
1470548|NCT00704730|Secondary|Biochemical Response Calcitonin (CTN) %|For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject’s time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of >50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of >50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.|Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.|Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.|||% participants|||Number
1470567|NCT00704418|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis(LOCF), ITT Population|||participants|||Number
1470595|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Time of Skin Closure to Hospital Discharge.||30 days||||Percentage of participants|||Number
1470549|NCT00704730|Secondary|Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined|For those subjects with Independent Radiology Committee (IRC) determined Objective Response Rate (ORR), the amount of time from documentation of Objective Response (OR) until Progressive Disease (PD) by mRECIST or death due to any cause.|From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.|The primary analysis of Objective Response Rate (ORR) was performed among the subset of Intent To Treat (ITT) subjects with measurable disease at baseline and was based upon response as determined by the Independent Review Committee (IRC.) Subjects who did not have post-baseline adequate tumor assessments were counted as nonresponders.|||months||95% Confidence Interval|Median
1470550|NCT00704730|Secondary|Objective Response Rate (ORR)|The proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) as determined by the Independent Review Committee (IRC.) Per Response Evaluation Criteria in Solid Tumor Criteria (mRECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) ≥ 20% increase in the sum of the longest diameter of target lesions. Overall Response Rate: ORR=CR +PR|Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.|The primary analysis Objective Response Rate (ORR) was performed among subset of Intent To Treat (ITT) subjects with measurable disease at baseline (N = 208 cabozantinib, N = 104 placebo) based upon response determined by Independent Radiology Committee (IRC.) Subjects without post-baseline adequate tumor assessments - counted as nonresponders.|||% of participants|||Number
1470551|NCT00704730|Secondary|Overall Survival (OS) With XL184 Compared With Placebo|Duration of Overall Survival (OS) from the time of randomization to death due to any cause. A Kaplan-Meier analysis was performed to estimate the median.|The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.|Intent to treat (ITT) randomized to either XL184 or placebo|||months||95% Confidence Interval|Median
1470552|NCT00704730|Primary|Progression-Free Survival (PFS)|The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.|Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.|Intent to Treat (ITT) 330 subjects were randomized and were included in the analysis. A Kaplan-Meyer analysis was performed to estimate the median.|||months||95% Confidence Interval|Median
1470553|NCT00704717|Primary|Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey.|The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen.|The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment.||||Units on a scale||Standard Deviation|Mean
1470554|NCT00704535|Primary|Tolerability as Measured by Subject Self-assessment|Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment|28 days after Visit 1||||subjects|||Number
1470555|NCT00704535|Primary|Safety as Measured by Outcome of Adverse Events|To evaluate overall safety of ezetimibe as measured by outcome of adverse events|28 days after Visit 1||||adverse events|||Number
1470556|NCT00704535|Primary|Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event|To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event|28 days after Visit 1||||adverse event|||Number
1470557|NCT00704535|Primary|Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.|To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.|28 days after Visit 1||||adverse events|||Number
1470558|NCT00704535|Primary|Safety as Measured by Severity of Adverse Events as Determined by the Investigator|To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator|28 days after Visit 1||||adverse events|||Number
1470559|NCT00704535|Primary|Safety as Measured by Number and Type of Adverse Events.|Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.|28 days after Visit 1||||adverse events|||Number
1470560|NCT00704535|Secondary|To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)|Change in mean total cholesterol values|28 days after Visit 1|All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements|||mg/dL||Standard Deviation|Mean
1470561|NCT00704535|Primary|Safety as Measured by Number of Subjects With at Least One Adverse Event|Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event|28 days after Visit 1||||subjects|||Number
1470562|NCT00704522|Primary|Average Length of Treatment With PegIntron/Rebetol||After start of treatment|Number of participants who received study drug|||Weeks||Standard Deviation|Mean
1470563|NCT00704522|Primary|Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program||24 or 48 weeks (depending on genotype) and 24 weeks of follow up|All participants|||Participants|||Number
1470564|NCT00704496|Secondary|Improvement of Daytime Somnolence With Pseudoephedrine as Compared to Placebo|daytime sleepiness by subjective questionnaires|3 years|data disposed of and no longer in existence||||||
1470565|NCT00704496|Primary|Improvement of Sleep Associated With the Use of Pseudoephedrine as Compared to the Placebo|sleep improvement by subjective questionnaires|3 years|data disposed of and no longer in existence||||||
1470566|NCT00704418|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses|Day 1|LOCF Analysis, ITT Population|||participants|||Number
1470569|NCT00704405|Secondary|Percentage of Participants Achieving cEVR|The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.|Up to Week 60|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis.|||Percentage of participants|||Number
1470570|NCT00704405|Secondary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.|The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.|72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
1470571|NCT00704405|Primary|Number of Participants Discontinuing From Study Treatment Due to AEs|The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.|Up to 48 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.|||Number of participants|||Number
1470572|NCT00704405|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|Up to 73 weeks|The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.|||Number of participants|||Number
1470573|NCT00704405|Primary|Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.|The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.|Up to 72 weeks|The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.|||Percentage of participants|||Number
1470574|NCT00704379|Secondary|Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus)|"FA is a measured obtained from Diffusion Tensor Imaging, an image modality of Magnetic Resonance Imaging (MRI). FA is a unitless index. Range: 0 to 1. FA describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted or equally restricted in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. In the context of this study, FA measures the integrity of the cingulate gyrus white matter. Higher FA values reflect higher integrity of the cingulate gyrus white matter tract. Average FA values for the right and left cingulate gyri were summed.~One aim of this project was to identify predictors of the occurrence of mood disturbances during the first 6 months following TBI. The hypothesis for this aim was that patients who develop a mood or anxiety disorder six months after TBI present at baseline with lower FA of the cingulate gyrus than those who do not."|Baseline|Of the 94 participants randomized, only 61 participants had an MRI and were included in the analysis of this study aim.|||unitless index||Standard Deviation|Mean
1470575|NCT00704379|Secondary|Social Functioning Examination Total Score|The Social Functioning Examination (SFE) is a semi-structured interview that measures social functioning in areas such as interpersonal relationships, work adjustment, use of community resources and satisfaction with living environment. Range: 0 to 1. Higher scores denote lower levels of social functioning.|6 months after TBI|Out of the 80 participants who completed the trial, only 63 completed SFE at this evaluation time.|||units on a scale||Standard Deviation|Mean
1470576|NCT00704379|Secondary|Memory Function Composite|This outcome measures memory function and is a composite of five standardized scores: Brief Visuospatial Memory Test - Revised, Delayed Recall and California Verbal Learning Test, Short Delay Free Recall Number Correct and Discriminability, and Long Delay Free Recall Number Correct and Discriminability. Standardized scores (i.e., z-scores) for each test of this composite were obtained by subtracting the mean raw score of all participants to the raw score of each participant and dividing the result by the standard deviation of the raw scores of all participants. The composite score was obtained by averaging the z-scores of the four memory tests mentioned previously. Range: -3 to 3. Higher scores represent better memory function.|6 months following traumatic brain injury|Out of the 80 participants who completed the trial, only 61 completed all the tests necessary to calculate the composite score at this evaluation time.|||z-scores||Standard Deviation|Mean
1470577|NCT00704379|Secondary|Iowa Gambling Task Score|The Iowa Gambling Task (IGT) evaluates decision making ability. During IGT subjects have to choose between decks of cards which yield high immediate gain but larger future loss (i.e., long term loss), and decks which yield lower immediate gain but a smaller future loss (i.e., a long term gain). The task consists of four decks of cards: A, B, C, and D. The goal in the task is to maximize profit. Subjects are required to make a series of card selections. The decks A and B are long term loss decks and the decks C and D are long term gain decks. The IGT Score reported is the combination of the raw score for each deck combined in the following way: (C+D) - (A+B). The range for this score is: -100 to 100. Higher values of this score indicate better decision making ability.|6 months after TBI|Out of the 80 participants who completed the trial, only 64 completed IGT at this evaluation time.|||units on a scale||Standard Deviation|Mean
1470664|NCT00703729|Primary|Patient Reported Pain on Day 1|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470578|NCT00704379|Secondary|Total Community Integration Questionnaire Scores|The Community Integration Questionnaire (CIQ) is intended as a brief, reliable measure of an individual’s level of integration into the home and community following traumatic brain injury. Total CIQ scores were used as the outcome measure. Range: 0 to 25. Higher scores indicate higher levels of integration into the home and community following TBI.|6 months after TBI|Out of the 80 participants who completed the trial, only 68 completed CIQ at this evaluation time.|||units on a scale||Standard Deviation|Mean
1470579|NCT00704379|Primary|Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI)|"Following the DSM-IV (now updated by the DSM-5), depressive disorders associated with TBI are categorized as Mood Disorder Due to Another Medical Condition with subtypes: 1) With major depressive-like episode (if the full criteria for a major depressive episode [MDE] are met) or 2) With depressive features (prominent depressed mood but full criteria for a MDE are not met); and 3) with mixed features (e.g. significant irritability, pressured speech and formal thought disorder).~On the other hand, bipolar and related disorders due to TBI are subdivided in: 1) with manic or hypomanic like episode; 2) with manic features; and 3) with mixed features.~A similar conceptual framework has been used to define Anxiety Disorder due to another Medical Condition, in this case, TBI. According to DSM-IV/DSM-5, such diagnosis can be made when, besides an evident pathophysiological relationship with TBI, panic attacks or generalized anxiety are the prominent features of the clinical presentation."|6 months after TBI||||weeks||Standard Error|Mean
1470580|NCT00704353|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)||through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)||||participants|||Number
1470581|NCT00704340|Secondary|Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak|"As determined from clinical diagnosis by one of the following methods:~CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 30 days post-operation~CSF leak confirmation by diagnostic testing within 30 days post-operation~CSF leak confirmation by clinical evaluation including physical examination of the surgical site within 30 days post-operation"|30 days||||percent of subjects||95% Confidence Interval|Number
1470582|NCT00704340|Secondary|Percentage of Subjects With Post-operative Surgical Site Infections||30 days||||percent of subjects||95% Confidence Interval|Number
1470583|NCT00704340|Primary|Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.|"Surgical Wound Complications;~Superficial incisional surgical site infection (SSI)~Deep incisional SSI~Organ/Space SSI~Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery~Poor wound healing~Central Nervous System Events;~Cerebrospinal Fluid (CSF) leak~Hydrocephalus~Bacterial meningitis~Aseptic meningitis~In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted."|30 days||||percent of subjects||95% Confidence Interval|Number
1470584|NCT00704184|Secondary|Mean Log Change From Baseline in HCV RNA|The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Log10 IU/mL||Standard Deviation|Mean
1470585|NCT00704184|Secondary|Number of Participants With ≥3-log10 Decrease in HCV RNA|The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Number of Participants|||Number
1470586|NCT00704184|Secondary|Number of Participants With ≥2-log10 Decrease in HCV RNA|The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.|Baseline and Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Number of Participants|||Number
1470587|NCT00704184|Primary|Number of Participants Discontinuing From Study Therapy Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.|Day 1 to Day 28|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy|||Participants|||Number
1470588|NCT00704184|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.|Up to Day 42|The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.|||Participants|||Number
1470589|NCT00704184|Primary|Percentage of Participants Achieving RVR|Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.|Week 4|The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.|||Percentage of Participants|||Number
1470590|NCT00704171|Primary|Percentage of Subjects Remaining Air Leak Free From Skin Closure to Discharge|Sub-analysis by pre-randomization grade of air leak. Grade 1= countable air bubbles, Grade 2= stream of bubbles, Grade 3= coalesced bubbles|30 days|Analysis by grade of air leak.Grade 1= countable air bubbles, Grade 2= Stream of bubbles, Grade 3 = Coalesced bubbles.|||Percentage of participants|||Number
1470591|NCT00704171|Secondary|Duration of Hospitalization||30 days||||hours||Standard Deviation|Median
1470592|NCT00704171|Secondary|Duration of Chest Drainage||30 days||||hours||Standard Deviation|Median
1470593|NCT00704171|Secondary|Time From Skin Closure to Last Observable Air Leak.||30 days||||hours||95% Confidence Interval|Median
1470594|NCT00704171|Secondary|Percentage of Subjects for Whom Intra-operative Air Leak Sealing Success is Achieved.|Success is defined as no presence of air leak intra-operatively.|Intra-operatively, time of study procedure||||Percentage of participants|||Number
1470596|NCT00704132|Primary|Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6|Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.|Baseline and Week 6|Full-Analysis-Set (FAS) population, which includes all randomized participants who had a baseline value, received at least one dose of randomized treatment, and had a measurement at Week 6.|||mg*hr/dL||95% Confidence Interval|Least Squares Mean
1470597|NCT00704028|Primary|The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)||Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer||||participants|||Number
1470598|NCT00703976|Secondary|2-year Overall Survival (OS)|Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.|2 years of follow-up after closing accrual||||percentage of participants||95% Confidence Interval|Number
1470599|NCT00703976|Primary|2-year Progression-free Survival (PFS)|Two-year PFS is an estimated percentage of participants without disease progression (locoregional or distant) at two years after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as: at least a 20% (and at least 5 millimeters) increase in the sum of the diameters of target lesions, or the appearance of one or more new lesions.|18 months to patient accrual and 2 years of follow-up after closing accrual.||||percentage of participants||90% Confidence Interval|Number
1470600|NCT00703963|Secondary|Mean Number of INR Tests Performed||baseline to 3 months||||INR tests||Standard Deviation|Mean
1470601|NCT00703963|Secondary|Mean Percentage of INR Tests Within the Therapeutic Range||baseline to 3 months||||percentage of tests||Standard Deviation|Mean
1470602|NCT00703963|Primary|Mean Percentage of Time in Therapeutic Range||baseline to 3 months||||percentage of time||Standard Deviation|Mean
1470603|NCT00703937|Primary|Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC|Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent|First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer||||participants|||Number
1470604|NCT00703924|Secondary|Rate of Relapse|"Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher’s exact test.~Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher’s exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable."|180 days||||Participants|||Count of Participants
1470605|NCT00703924|Secondary|Final Cure Rate by Subject of All Lesions|Final cure rate by subject was determined using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable.|180 days||||Participants|||Count of Participants
1470606|NCT00703924|Secondary|Time to Complete Re-epithelialization of the Index Lesion Ulcer Without Relapse|100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization.|180 days|Days to 100% re-epithelialization of index lesion. Volunteer Identification Number (VIN). VINs 17, 72, and 109 failed to meet 100% re-epithelialization|||Participants|||Count of Participants
1470607|NCT00703924|Primary|Safety of WR 279,396 (AEs and SAEs)|Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations.|180 days|All solicited local and systemic AEs and SAEs including immediate and delayed reactions that occurred during this study are summarized.|||Adverse Events|||Number
1470608|NCT00703924|Primary|Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days)|CCR is defined as at least 50% reduction, from baseline, in index lesion area of ulceration at study days 50, 100 and 180 (+ 7 days). Randomized subjects were compared using the uncorrected Fisher's exact test. Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher’s exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable. The Breslow-Day test was used to examine whether the effect of WR 279,396 varied between subgroups|180 days||||Participants|||Count of Participants
1470609|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470610|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Initial Dose (All Bleed Episodes)|"Percentage of bleeds with effective pain relief within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: Better = pain resolved or decreased substantially; Same = no change; Worsened = pain worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470665|NCT00703729|Secondary|Use of Pain Medication on Day 1|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1470611|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (Spontaneous Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470612|NCT00703911|Other Pre-specified|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleed) by Dose Level (All Bleed Episodes)|"Percentage of bleeds with effective haemostasis within 9 hours of first injection of activated recombinant human factor VII. Patient reported assessments were sorted into 3 sub-categories: effective = bleed resolved or substantially improved; partially effective = bleed with some improvement; ineffective = bleed with no change or with worsening."|within 9 hours after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470613|NCT00703911|Secondary|Adults' Health Related Quality of Life (Haemo-QoL-A): Overall Score|The adult Haemo-QoL-A is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of adult subjects above 16 years included in the study that completed the questionnaire at baseline and/or at discontinuation|||scores on a scale||Standard Deviation|Mean
1470614|NCT00703911|Secondary|Childrens' Health Related Quality of Life (Haemo-QoL): Overall Score|The Haemo-QoL is a specific multidimensional validated and reliable questionnaire used to assess quality of life in patients with haemophilia. Scores are reported on a 0 to 100 scale—higher scores indicate more impairment.|Baseline (week 0) and and registry discontinuation (up to 28 months)|A subset of paediatric subjects age 4 to 16 (inclusive) included in the study that completed the questionnaire at baseline and/or at discontinuation|||scores on a scale||Standard Deviation|Mean
1470615|NCT00703911|Secondary|Overall Time to Cessation/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable.|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose, excluding bleed episodes treated with more than one dose for which > 24 hours between the 1st and 2nd dose was reported (bleed episodes with > 24 hours between 1st and 2nd rFVIIa dose likely reflects treatment of re-bleeding or prophylactic/maintenance dosing)|||minutes||95% Confidence Interval|Median
1470616|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (Spontaneous Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||minutes||95% Confidence Interval|Median
1470617|NCT00703911|Secondary|Overall Time to Cessation of Bleed/Achievement of Haemostasis (All Bleed Episodes)|Median time to achievement of haemostasis/bleed cessation calculated using Kaplan Meier life table methods. If approximately 50% or less of bleeds achieved the endpoint in a given initial dose subgroup, the median cannot be calculated and it is reported as not applicable|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||minutes||95% Confidence Interval|Median
1470618|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (Spontaneous Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470619|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Ease of Use (All Bleed Episodes)|"Rate of ease of use related to activated recombinant human factor VII on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely difficult to extremely easy. The percentage of bleed episodes for which patients reported extremely easy, very easy or easy is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470620|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Patient Satisfaction With Symptom Relief (Spontaneous Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470621|NCT00703911|Secondary|Percentage of Patients Reporting Satisfaction With Symptom Relief (All Bleed Episodes)|"Patient rate of satisfaction with symptom relief for the bleed episode overall on a 7-point Likert scale. Completion of questionnaire was voluntary. A Likert scale is an ordered, multiple choice questionnaire from which respondents choose one option that best aligns with their view of the particular outcome being measured. Scale answers ranged from extremely satisfied to extremely dissatisfied. The percentage of bleed episodes for which patients reported extremely satisfied, very satisfied or satisfied is presented."|duration of bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470622|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (Spontaneous Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes. Excludes bleeds episodes with > 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing, and 2 bleed episodes categorised as CNS that would not meet criteria of mild to moderate spontaneous bleed episodes|||mcg/kg||Full Range|Median
1470623|NCT00703911|Secondary|Total Exposure (Cumulative Dose) to Activated Recombinant Human Factor VII (All Bleed Episodes)|The median total cumulative dose required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level. Excludes bleeds episodes with greater than 24 hours between 1st and 2nd rFVII dose where total cumulative dose recorded likely reflects treatment of re-bleeding or prophylactic/maintenance dosing|||mcg/kg||Full Range|Median
1470624|NCT00703911|Secondary|Total Number of Injections (Spontaneous Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is spontaneous bleed episodes treated with any initial dose|||injections||Inter-Quartile Range|Median
1470625|NCT00703911|Secondary|Total Number of Injections (All Bleed Episodes)|The median number of injections required to treat individual bleed episodes.|individual bleed episode|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||injections||Inter-Quartile Range|Median
1470626|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (Spontaneous Bleed Episodes)|Effective pain relief at 3 different time points for spontaneous bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470627|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Pain Relief by Time Point (All Bleed Episodes)|Effective pain relief at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470628|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (Spontaneous Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470629|NCT00703911|Secondary|Percentage of Bleed Treatments Resulting in Effective Haemostasis (Cessation of Bleeds) by Time Point (All Bleed Episodes)|Effective haemostasis at 3 different time points for all bleeds. Patient reported outcomes are reported over 1 hour, 3 hours and 6 hours.|1 hour, 3 hours and 6 hours, respectively, after first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470630|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (Spontaneous Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470631|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Pain Relief (All Bleed Episodes)|The percentage of participants with effective pain relief. Pain relief was a subjective assessment made by the patient during treatment of a bleed episode.|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470632|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (Spontaneous Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is spontaneous bleed episodes treated with any initial dose|||percentage of bleed episodes|||Number
1470633|NCT00703911|Primary|Percentage of Bleed Treatments Resulting in Effective Bleed Resolution (All Bleed Episodes)|"The percentage of bleed treatments successfully resulting in bleed resolution. Analysis only considers the patient's opinion of effectiveness at 9 hours, with a rating of Effective considered as successful treatment."|within 9 hours of first injection|Analysis set is all bleed episodes, regardless of bleed type or initial dose level|||percentage of bleed episodes|||Number
1470634|NCT00703885|Primary|Voxelwise Brain Imaging Data|Analysis of data not completed.|Post-Rx Administration|||||||
1470635|NCT00703885|Primary|Effect of Alprazolam Versus Placebo on BOLD fMRI During Emotion Processing|Analysis not completed.|Same Day|||||||
1470636|NCT00703846|Secondary|Mean Change From Baseline for the Functional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the functional component, participants were asked to answer 15 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Functional Score is the sum of the 12 question scores; total score ranges from 15 to 75.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1470666|NCT00703729|Primary|Patient Reported Pain on Day 0|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470667|NCT00703677|Secondary|Geriatric Depression Scale(GDS)-15:Change From Baseline|The GDS-15 is a 15-item instrument used to screen for depression in the elderly. Subjects will be assessed at the Screening Visit and at Week 28.|28 weeks|||||||
1470637|NCT00703846|Secondary|Mean Change From Baseline for the Emotional Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the emotional component, participants were asked to answer 10 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Emotional Score is the sum of the 10 question scores; total score ranges from 10 to 50.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1470638|NCT00703846|Secondary|Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. For the symptomatic component, participants were asked to answer 7 questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Symptomatic Score is the sum of the 7 question scores; total score ranges from 7 to 35.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1470639|NCT00703846|Secondary|Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination)|Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.|Baseline and Week 52 (or Early Termination)|Safety Analysis Set. Participants who submitted incomplete questionnaires (missing values) were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
1470640|NCT00703846|Secondary|Median Number of Flare Days|The median number of flare days for all participants was calculated based on data self-reported in diaries that participants kept during the study. The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare day is defined as a day on which flare signs and symptoms for seborrheic dermatitis (erythema, scaling, and pruritus of the target area) occurred.|From baseline through 52 weeks|Safety Analysis Set|||flare days||Full Range|Median
1470641|NCT00703846|Secondary|Median Number of Flares|The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare is defined as a clinical diagnosis and presentation of seborrheic dermatitis that shows as an erythematous, thin, scaly patch with a greasy sandpaper texture that varies depending on disease severity. Flares are commonly seen on the scalp, nasal folds, eyebrows, glabella, upper eyelids, retroauricular/external ear canal, and midchest areas.|From baseline through 52 weeks|Safety Analysis Set|||flares||Full Range|Median
1470642|NCT00703846|Secondary|Mean Change From Baseline in Investigator’s Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|"This seborrhoeic dermatitis-specific ISGA scale (range=0-4) is used to assess skin condition severity without considering changes over time (static). 0=clear, except for minor residual discoloration; 1-4=majority of lesions have average scaling/erythema scores of 1-4, respectively. 1=almost clear, occasional fine scale, faint erythema/barely perceptible plaque thickness; 2= mild, fine scale with light coloration/mild plaque elevation; 3=moderate, coarse scale with moderate red coloration/moderate plaque thickness; 4=severe, thick tenacious scale with deep coloration/severe plaque thickness."|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1470643|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for pruritis ranges from 0 to 4; 0=No itching; 1=Minimal: rarely aware of itching; 2=Mild: only aware of itching at times; only present when relaxing; not present when focused on other activities; 3=Moderate: often aware of itching; annoying; sometimes disturbs sleep and daytime activities; 4=Severe: constant itching; distressing; frequent sleep disturbance; interferes with activities. Pruritus is defined as an itching/scratching sensation.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1470644|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline in skin assessments for scaling was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for scaling ranges from 0 to 4; 0=Normal skin with rare fine scale; 1=Minimal: occasional fine scales over less than 10% of the lesions; 2=Mild: fine scales predominate; 3=Moderate: coarse scales predominate; 4=Severe: thick tenacious scales predominate. Scaling of skin is the loss of the outer layer of the epidermis in large, scale-like flakes.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1470668|NCT00703677|Secondary|Frontal Assessment Battery (FAB): Change From Baseline|The FAB is a brief, 6-item instrument designed to assess executive function. Subjects will be assessed at baseline and at Week 28.|28 weeks|||||||
1483605|NCT00598832|Primary|Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12||Baseline to Week 12||||Absolute Change in Total Lesion Count||Standard Error|Least Squares Mean
1470645|NCT00703846|Secondary|Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination)|Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or early termination) value minus the baseline value. The grading scale for erythema ranges from 0 to 4; 0=Normal skin without erythema; may have residual hyper/hypopigmentation; 1=Faint erythema; may have residual hyper/hypopigmentation; 2=Light red erythema; may have residual hyper/hypopigmentation; 3=Moderate red coloration; 4=Dusky to deep red coloration. Erythema was defined as redness of the skin caused by increased blood circulation in the capillaries found in the deeper layers of the skin.|Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)|Safety Analysis Set. Participants withdrew from the study as the study progressed, and data were missing for some participants. There were no imputation methods used for missing data for any analysis.|||units on a scale||Standard Deviation|Mean
1470646|NCT00703846|Primary|Number of Participants With Any Adverse Event (AE)|"An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled Other (Non-Serious) Adverse Events."|From baseline through 52 weeks|Safety Analysis Set: all participants who had used the study product at least once|||participants|||Number
1470647|NCT00703820|Secondary|Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.||3 years after completion of therapy|||||||
1470648|NCT00703820|Secondary|Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.||3 years after completion of therapy|||||||
1470649|NCT00703820|Primary|Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry|MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.|Day 22 MRD measurement after one course of therapy|Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.|||Participants|||Count of Participants
1470650|NCT00703781|Secondary|Number of Participants That Are Pain Free|Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop|Day 1|LOCF Analysis, ITT Population|||Participants|||Number
1470651|NCT00703781|Primary|Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero|Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense)|Day 15|Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT)|||Participants|||Number
1470652|NCT00703729|Secondary|Use of Pain Medication on Day 7|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1470653|NCT00703729|Secondary|Use of Pain Medication on Day 6|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1470654|NCT00703729|Secondary|Use of Pain Medication on Day 5|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1470655|NCT00703729|Secondary|Use of Pain Medication on Day 4|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1470656|NCT00703729|Secondary|Use of Pain Medication on Day 3|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1470657|NCT00703729|Secondary|Use of Pain Medication on Day 2|Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone|1 day||||Morphine Equivalent Dosage||Standard Deviation|Mean
1470658|NCT00703729|Primary|Patient Reported Pain on Day 7|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470659|NCT00703729|Primary|Patient Reported Pain on Day 6|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470660|NCT00703729|Primary|Patient Reported Pain on Day 5|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470661|NCT00703729|Primary|Patient Reported Pain on Day 4|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470662|NCT00703729|Primary|Patient Reported Pain on Day 3|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470663|NCT00703729|Primary|Patient Reported Pain on Day 2|"Pain was measured using a visual analog scale (VAS) 10 cm in length, with no pain at the left side of the scale and extreme pain at the right side. Scores were measured to the closest millimeter for a 0-100 scale."|1 day||||Visual Analog Score (0-100)||Standard Deviation|Mean
1470669|NCT00703677|Secondary|PSP-Quality of Life Scale (QoL):Change From Baseline|The PSP-QoL Scale is an instrument designed to assess mental and physical aspects of quality of life specifically in patients with PSP. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks|||||||
1470670|NCT00703677|Secondary|Unified Parkinson Disease Rating Scale (UPDRS) Motor Subscale Score: Change From Baseline|The UPDRS is a commonly used clinical rating scale to assess motor function in patients with parkinsonism. Subjects will be assessed at baseline and Weeks 5, 12, 20, and 28.|28 weeks|||||||
1470671|NCT00703677|Secondary|PSP Rating Scale Score: Change From Baseline|The PSP Rating Scale is a 28-item scale designed to assess the disability associated with PSP. The six functional categories assessed are: daily activities, behavior, bulbar function, oculomotor function, limb motor function, and gait/midline function. Subjects will be assessed at baseline and Weeks 12, 20, and 28.|28 weeks|||||||
1470672|NCT00703677|Secondary|Change in Glycogen Synthase Kinase (GSK)-3 Beta Activity|Levels of beta-catenin and the ratio of phosphorylated GSK-3 beta to total GSK-3 beta will be measured at baseline and at Week 28|28 weeks|Due to the very small number of samples collected, samples were not analyzed.||||||
1470673|NCT00703677|Secondary|Change in Brain-Derived Neurotrophic Factor (BDNF) in CSF|With inhibition of Glycogen Synthase Kinase (GSK)-3 beta, levels of BDNF may increase. BDNF levels will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed||||||
1470674|NCT00703677|Secondary|Changes in Amount of Tau and Phosphorylated Tau in Cerebral Spinal Fluid (CSF)|Progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are characterized by hyperphosphorylation of tau. Lithium inhibits one of the kinases (GSK-3 beta) that phosphorylates tau; levels of tau phosphorylation will be measured at baseline and at Week 28.|28 weeks|Due to the very small number of samples collected, samples were not analyzed||||||
1470675|NCT00703677|Secondary|Study Drug Compliance|Subjects receiving 80% or more of the prescribed doses between study visits were considered compliant.|28 weeks|All subjects were evaluated for compliance.|||Subjects|||Number
1470676|NCT00703677|Primary|Ability to Tolerate Lithium Carbonate|The ability to complete the study period on lithium at a serum concentration of at least 0.4 mEq/L.|28 weeks|One subject completed the full 28 week course of study drug; 13 subjects stopped drug early due to intolerability.|||Subject|||Number
1470677|NCT00703664|Secondary|Duration of Stable Disease|Median duration of stable disease per cohort.|Up to 9 years|All participants with stable disease.|||months||Full Range|Median
1470678|NCT00703664|Secondary|Duration of Partial Response|Median duration of response per cohort.|Up to 9 years|All participants with Partial Response.|||months||Full Range|Median
1470679|NCT00703664|Secondary|Progression-free Survival (PFS)|Median progression-free survival in months per cohort.|Up to 9 years|All evaluable participants at time of analysis. Cohort B was closed early due to lack of accrual.|||months||95% Confidence Interval|Median
1470680|NCT00703664|Secondary|Best Response|Number of participants per category: Partial Response (PR), Stable Disease (SD), Progressive Disease (PD). PR: Regression of measurable disease and no new sites. SD: Failure to attain Complete Response (CR), /PR or PD. Relapsed or Progressive Disease: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.|Up to 9 years|All participants evaluable and available at time of assessment.|||Participants|||Count of Participants
1470681|NCT00703664|Primary|Overall Response Rate (ORR)|ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma.|Up to 9 years|All participants.|||percentage of participants|||Number
1470682|NCT00703534|Primary|Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary|Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)|Run-in period of 8-12 days and treatment period of 26-30 days|None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.|||participants|||Number
1470683|NCT00703508|Secondary|Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.|Bivariate fit (RSquare with P values) of ovulation rate post treatment by change in total testosterone and Matsuda Index for each of the 3 genotypes (G/G, C/G, C/C)|9 months|Individuals that were lost to follow up had missing data on testosterone and OGTT (oral glucose tolerance testing) for Matsuda index.|||Correlation coefficient (r^2)|||Number
1470684|NCT00703508|Primary|Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG|Ovulations were determined by measurement of daily urine pregnanediol-3-glucuronide or weekly progesterone levels over 6-9 months of study duration for each participant. The ovulation rate was calculated as the number of confirmed ovulation events per months of study participation.|9 months||||ovulations/month||Standard Deviation|Mean
1470685|NCT00703508|Primary|Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)|Responders were defined as those that had a doubling of baseline ovulation rate estimated by self-report of menstrual history.|9 months||||participants|||Number
1470686|NCT00703391|Primary|Renal Clearance of Drug From Plasma (CLR)|CLR following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||L/h||Full Range|Geometric Mean
1470687|NCT00703391|Primary|Terminal Half-life of Drug in Plasma (t1/2)|t1/2 following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||hours||Full Range|Median
1470688|NCT00703391|Primary|Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)|tmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||hours||Full Range|Median
1470689|NCT00703391|Primary|Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)|Cmax following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||nM||Full Range|Geometric Mean
1470690|NCT00703391|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))|AUC(0-12) following 14 days' dosing|Pre-dose on day -1 to day 15 (end of dosing)||||nM.h||Full Range|Geometric Mean
1470691|NCT00703391|Primary|FEV1 (Forced Expiratory Volume in the First Second)|Change from baseline to Day 14|Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)||||L||Standard Deviation|Mean
1470706|NCT00703339|Secondary|Pharmacokinetic (PK) Parameters After a Single Dose of Inhaled Treprostinil and Acute Hemodynamic Effects.|PK samples will be collected at frequent intervals up to 4 hours following single dosing . Hemodynamic parameters at 4 hours post dosing include heart rate, pulmonary arterial pressure, systemic arterial pressure, right atrial pressure, pulmonary capillary wedge pressure, mixed venous oxygen saturation and cardiac output.|acute|Insufficient enrollment, therefore no participants were analyzed.||||||
1470707|NCT00703339|Primary|Safety and Tolerability of Inhaled Treprostinil Sodium in Patients With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis,Reported as Number of Participants With Adverse Events|Safety and Tolerability evaluation include any observed or reported changes in vital signs, ECGs, clinical chemistry ,hematological or urinalysis, and any reported symptoms following a single dose administration on the day of dosing and up to the final visit 3-5 days later. Adverse events will be tabulated by total incidence and by individual patient, and the severity, causality and outcomes will also be documented. Each cohort of 4 patients will be fully evaluated as described before proceeding to the escalation to the next dose.|3-5 days|Insufficient enrollment, therefore no Participants were analyzed.||||||
1470708|NCT00703326|Secondary|Number of Participants With Adverse Events|Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and other NSAEs is located in the Reported Adverse Event module.|First dose to study completion (up to 49 months) plus 30-day safety follow-up|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
1470709|NCT00703326|Other Pre-specified|Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)|The overall percentage of participants with treatment-emergent positive for anti-ramucirumab (IMC-1121B) antibodies during the study. Participants were considered positive for anti-ramucirumab (IMC-1121B) antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-ramucirumab (IMC-1121B) level seen in healthy untreated individuals.|Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event until data cutoff of 31-Mar-2013 (up to 31 months)|All randomized participants who received at least 1 dose of study drug with anti-IMC-1121B antibodies samples collected during the study.|||percentage of participants|||Number
1470710|NCT00703326|Secondary|Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy|FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), and additional concerns of breast cancer subscale (BCS) each with 6 or more items developed to measure problems specific to breast cancer symptoms plus additional items related to global QoL. Participants respond to each of the 36 questions on a 5-point scale from 0 (not at all) to 4 (very much) with a total scores range of 0-144. Higher scores indicate fewer symptoms and better HR-QoL.|Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 42 months)|A subset of Intent-to-Treat (ITT) Population: all randomized participants with a valid baseline and end of therapy assessments.|||units on a scale||Standard Deviation|Mean
1470711|NCT00703326|Secondary|Duration of Response|Duration of complete response (CR) or partial response (PR) measured from time criteria were first met for CR or PR until first date of progressive disease (PD) or death from any cause defined using Response Evaluation Criteria in Solid Tumor (RECIST 1.0); by Investigator assessment. CR defined as disappearance of all target and non-target lesions. PR defined as ≥30% decrease in sum of longest diameter (LD) of target lesions and no progression in non-target lesions. PD defined as ≥20% increase in LD sum of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of ≥1 new lesion(s). Participants who did not relapse or die censored at day of last radiographic tumor assessment. If death or PD was after ≥2 missing radiographic visits, censoring was at date of last radiographic visit prior to missed visits. Symptomatic/clinical disease progression without documented radiologic progression did not constitute progression.|Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 35 months)|A subset of the Intent-to-Treat (ITT) Population: all randomized participants with CR or PR. Censored participants: ramucirumab + docetaxel=80, placebo + docetaxel=28.|||months||95% Confidence Interval|Median
1470712|NCT00703326|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1.0), based on the achievement of both measurement and confirmation criteria; by Investigator assessment. CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants.|||percentage of participants||95% Confidence Interval|Number
1470713|NCT00703326|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the first documented date of disease progression using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who did not progress were censored at the last radiographic tumor assessment. If no post-baseline assessment was available censoring occurred at the date of randomization. If PD occurred after 2 or more missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=263, placebo + docetaxel=104.|||months||95% Confidence Interval|Median
1470714|NCT00703326|Secondary|Overall Survival (OS)|OS was defined as the duration from randomization to death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive.|Randomization to death or until data cutoff of 31-Mar-2013 (up to 49 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=448, placebo + docetaxel=225.|||months||95% Confidence Interval|Median
1470715|NCT00703326|Primary|Progression-Free Survival (PFS)|PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after ≥2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.|Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 48 months)|Intent-to-Treat (ITT) Population: All randomized participants. Censored participants: ramucirumab + docetaxel=231, placebo + docetaxel=94.|||months||95% Confidence Interval|Median
1470716|NCT00703261|Secondary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all statin-naive participants who completed the study and had complete image sets.|||Percent reduction||90% Confidence Interval|Geometric Mean
1470717|NCT00703261|Primary|Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment|Vascular plaque inflammation was measured by 18FDG-PET imaging. Uptake of FDG by the carotid and thoracic aorta is expressed as the target, vessel wall to background, lumen ratio (TBR). TBRmax of an axial cross section of a vessel (a slice) is defined as the maximum TBR within a slice and TBRmeanmax is the mean of TBRmax for all slices in the qualifying segment. The qualifying segment is the left or right carotid or thoracic aorta with the greatest FDG uptake value at Baseline.|Baseline and Week 12|The analysis population includes all participants who completed the study and had complete image sets with usable data.|||Percent reduction||90% Confidence Interval|Geometric Mean
1470718|NCT00703157|Secondary|Left Atrial Dimension and Contractility||Through 24 months post-ablation|Data were not collected||||||
1470719|NCT00703157|Secondary|Reduced Anti-arrhythmic Drug Requirement||Through 24 months post-ablation|Data were not collected||||||
1470720|NCT00703157|Secondary|Assessment of AF Burden||Through 24 months post-ablation|Data were not collected||||||
1470721|NCT00703157|Secondary|Occurences of Treatment of Arrhythmic Episodes||Through 24 months post-ablation|Data were not collected||||||
1470722|NCT00703157|Secondary|Symptoms Associated With Atrial Arrhythmias||Through 24 months post-ablation|Data were not collected||||||
1470723|NCT00703157|Secondary|Reduced Number, Duration and Severity of AF Symptoms||Through 24 months post-ablation|Data were not collected||||||
1470724|NCT00703157|Secondary|Duration, Burden and Costs of Treatment Procedures||Through 24 months post- ablation|Data were not collected||||||
1470725|NCT00703157|Secondary|Mortality and Hospitalization||Time from procedure until 24 months post-ablation||||participants|||Number
1470726|NCT00703157|Secondary|Number of Subjects With Adverse Events, Associated With the Ablation Procedure||Time from procedure||||Participants|||Count of Participants
1470727|NCT00703157|Secondary|Treatment Failures Requiring Redo or Alternative Therapy||Time from procedure until 6 months post-ablation||||Participants|||Count of Participants
1470728|NCT00703157|Primary|Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.|AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.|Baseline through 3-6 months post-ablation||||percentage of time in AF||Standard Deviation|Mean
1470729|NCT00703118|Secondary|Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12|Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.|Week 4 and Week 12|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1470730|NCT00703118|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4||Baseline (Day 1) to Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||log10 IU/mL||Standard Deviation|Mean
1470731|NCT00703118|Secondary|Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)|Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).|Up to Week 72|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1470732|NCT00703118|Secondary|Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8|Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.|Week 4, Week 6, or Week 8|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1470733|NCT00703118|Secondary|Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned|SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).|Week 60|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1470734|NCT00703118|Secondary|Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)||Week 48|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1470735|NCT00703118|Secondary|Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4|RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.|Week 4|All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Number
1470736|NCT00703118|Primary|Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned|SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.|Week 72|Full Analysis Set: All randomized participants who received at least one dose of study medication.|||Participants|||Number
1470737|NCT00703092|Secondary|Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.||||||
1470738|NCT00703092|Primary|Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.||10 months|This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.||||||
1470739|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses|The kinetics of the antibody response to vaccination with A/Vietnam/04 is evaluated by the HAI GMT against the A/Vietnam/04 antigen at weekly intervals after receipt of 2 doses 7, 14 and 28 days apart|Weeks 1, 2, 3 and 4 after the second dose|Analyses are based on a modified intent to treat population. 5 subjects in the VN/VN, Day 0, 28 group not receiving vaccination 2 are excluded, as were 2, also in this group, due to receipt of prohibited vaccines.|||Titer||95% Confidence Interval|Geometric Mean
1470740|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1470741|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1470742|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. The CI shown as 5.0 to 5.0 reflect that all subjects had a titer of 5.0 for the VN,VN, Day 0,14 and VN, Day 0 groups.|Six months after last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1470743|NCT00703053|Secondary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|Six months post last vaccination|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1470744|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470745|NCT00703053|Secondary|Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470791|NCT00702845|Secondary|Serum Progesterone (P) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum P were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||nmol/L||Full Range|Median
1472271|NCT00690378|Secondary|Microbiological Outcome in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1470746|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470747|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470748|NCT00703053|Primary|Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen|The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470749|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Indonesia/05 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470750|NCT00703053|Primary|Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470751|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1470752|NCT00703053|Secondary|Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Vietnam/04 Antigen|The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is <10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Participants|||Number
1470753|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1470754|NCT00703053|Secondary|Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1472875|NCT00685932|Primary|The Degree of Pain With Activity on Post-operative Day Number Two|Visual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.|2 days||||cm||Standard Deviation|Mean
1470755|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after the second vaccination and review the Memory Aid with clinic staff at a follow up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after second vaccination|All subjects receiving the second vaccination are included in this outcome measure. The VN, Day 0 Group received only one dose.|||Participants|||Number
1470756|NCT00703053|Secondary|Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.|7 days after first vaccination|All subjects receiving the first vaccination are included in the safety population and analyses of safety are ITT. Three subjects were randomized but not vaccinated.|||Participants|||Number
1470757|NCT00703053|Secondary|Number of Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 180 days after the last vaccination.|Duration of study|All subjects receiving at least one study vaccination are included in the safety population and analyses of safety are intention to treat (ITT). Three subjects were randomized but not vaccinated.|||Events|||Number
1470758|NCT00703053|Primary|Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen|The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.|28 days post last vaccination.|Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.|||Titer||95% Confidence Interval|Geometric Mean
1470759|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800) who had ET. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Percentage of Participants|||Number
1470760|NCT00703014|Primary|Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.|The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.|At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)|Mothers from the ITT group of the Base Trial P05787 (NCT00696800). Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Percentage of Participants|||Number
1470761|NCT00703014|Primary|Number of Infants in Current Follow Up Trial Experiencing SAEs|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.|||Participants|||Number
1470762|NCT00703014|Primary|Number of Infants Born in Current Follow Up Trial Experiencing AEs|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to 12 weeks following delivery (up to 1 year)|Infants born in Follow Up Trial P05712. Mothers were not analyzed in this outcome measure.|||Participants|||Number
1470763|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)|A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Participants|||Number
1470764|NCT00703014|Primary|Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)|An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.|Up to one day following delivery (up to 1 year)|Eligible Mothers from the Base Trial P05787 (NCT00696800) who enrolled in the Follow Up Trial P05712. Infants from Follow Up Trial P05712 were not analyzed in this outcome measure.|||Participants|||Number
1470765|NCT00702949|Secondary|Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment|Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better.|Baseline, after week 6 of treatment.||||units on a scale||Full Range|Median
1470766|NCT00702949|Primary|Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||percent change||95% Confidence Interval|Median
1470767|NCT00702949|Secondary|Toxicity Data for the Individual Study Arms From the Symptom Experience Diary .|A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions).|Baseline, 6 weeks during treatment.||||units on a scale||Full Range|Median
1470768|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||percent change||95% Confidence Interval|Median
1470769|NCT00702949|Secondary|Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm I: 63 EPs, 56 are EFP and 7 are not (3 off-study by refusal, 1 AE, 2 NODATA and 1 due to other medical reasons). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||units on a scale||95% Confidence Interval|Median
1470770|NCT00702949|Secondary|Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment||||percent change||95% Confidence Interval|Median
1470771|NCT00702949|Secondary|Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment||||Hot flashes per day||95% Confidence Interval|Median
1470772|NCT00702949|Primary|Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases).|Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA).|Baseline, after week 6 of treatment|Arm II: 66 EPs, 56 are EFP and 10 are not (2 off-study by refusal, 6 AE, 1 unknown reason and 1 NODATA). Arm III: 62 EPs, 51 are EFP and 11 are not (2 off-study by refusal, 3 AE, 3 NODATA and 3 due to other reasons).|||units on a scale||95% Confidence Interval|Median
1470773|NCT00702923|Secondary|Number of Participants With PSA Recurrence.|PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.|one year||||participants|||Number
1470774|NCT00702923|Secondary|The Number of Participants With an Increase in PSA Doubling Time||Up to 18 months after last dose of study agent||||participants|||Number
1470775|NCT00702923|Primary|The Number of Participants Who Developed Cancer Antigen-specific Immune Responses||Up to 12 months after treatment with study agent||||participants|||Number
1470807|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 3 (24 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1470776|NCT00702884|Secondary|Quantitative Assessment of Proliferating Tumor Cells and Apoptosis|Biopsy sample taken from patients before and after treatment Apoptosis measures using the terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) assay, which measures 3’ nicked DNA. DNA is degraded in the early steps of apoptosis into low molecular weight (LMW) fragments and the production of single strand breaks in the high molecular weight DNA.Both of these features of apoptosis can be detected by labeling free 3’-OH termini with modified nucleotides, in our case this will be biotin-labeled dUTP. Terminal deoxynucleotidyl transferase (TdT) is an enzyme that labels blunt-ends of DNA breaks and can catalyze polymerization of nucleotides to free 3’-OH DNA ends in a template-independent manner. The newly incorporated nucleotides are detected by a secondary antibody, avidin-peroxidase. After substrate reaction, the stained cells can be detected and counted under a light microscope. Apoptotic cells will be fixed with formaldehyde which links LMW DNA|up to 4 years|Analysis for tumor cells not performed due to insufficient samples available||||||
1470777|NCT00702884|Secondary|Change in Mean Vessel Density|Quantitative assessment of proliferating tumor cells, and apoptosis, of the laboratory and radiographic correlates, the analyses will be purely explorative.|up to 4 years|Insufficient tissue was available and the analysis for mean vessel density not performed||||||
1470778|NCT00702884|Secondary|Frequency and Severity of Adverse Events|The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.|up to 4 years||||percentage of patients|||Number
1470779|NCT00702884|Secondary|Median Progression-free Survival Time|Progression free survival was measured as the time from start of treatment to the first measurement of tumor growth.|up to 4 years||||weeks||95% Confidence Interval|Median
1470780|NCT00702884|Secondary|Median Overall Survival Time|The median overall survival time will be reported using the 95% confidence intervals for the parameters.|up to 4 years||||weeks||95% Confidence Interval|Median
1470781|NCT00702884|Secondary|Overall Response Rate|The Overall Response Rate (ORR) was assessed using Partial Response + Complete Response for patients. Response and progression was evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.|up to 4 years|Durable Complete Response= PR + SD > 10 weeks|||patients|||Number
1470782|NCT00702884|Primary|Progression-free Survival Rate|Complete response, partial response, and stable disease) as assessed by RECIST criteria at 24 weeks|up to 24 weeks||||weeks||95% Confidence Interval|Median
1470783|NCT00702845|Secondary|Number of Participants With Pregnancies|A Biochemical Pregnancy was defined as a pregnancy proven by a biochemical pregnancy test. (Participants not having a positive biochemical pregnancy test result, but with an ultrasound showing at least one gestational sac were counted as having a biochemical pregnancy.) A Clinical Pregnancy was defined as the presence of at least one gestational sac as assessed by an USS scan. A Vital Pregnancy was considered the presence of at least one fetus with heart activity as assessed by USS. An Ongoing Pregnancy was defined as the presence of at least one fetus with heart activity at least 10 weeks after ET as assessed by USS or Doppler, or confirmed by live birth.|Up to 10 weeks after ET (up to a maximum of 14 weeks)|ITT Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.|||Participants|||Number
1470784|NCT00702845|Secondary|Number of Participants With Miscarriages|"A miscarriage, also known as a spontaneous abortion, was defined as the loss of a fetus without induction or instrumentation."|Up to 10 weeks after ET (up to a maximum of 14 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who had a biological pregnancy.|||Participants|||Number
1470785|NCT00702845|Secondary|Implantation Rate for Participants With ET|The implantation rate was defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan (USS) after ET divided by the number of embryos transferred (per participant), maximized to 100%.|Up to 6 weeks after ET within a treatment cycle (up to a maximum 10 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ET.|||Percentage||Standard Deviation|Mean
1470786|NCT00702845|Secondary|Number and Quality of Embryos Obtained at Day 3 (Restricted to Participants With IVF and/or ICSI)|"Embryo quality was rated Grade 1, 2, 3, or other. Grade 1 represented excellent quality; Grade 2 good quality; Grade 3 fair quality. Other grade embryos were those that did not qualify as Grade 1, 2, or 3."|Post fertilization Day 3 (up to a maximum of 2 days after hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent IVF and/or ICSI.|||Number of embryos||Standard Deviation|Mean
1470787|NCT00702845|Secondary|Fertilization Rate|Fertilization rate, defined as 100 times the ratio of the number of fertilized 2 pronuclei (PN) oocytes obtained and the number of oocytes incubated, was tabulated for each treatment group.|Up to 10 weeks after ET|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received fertilized oocytes.|||Percentage||Standard Deviation|Mean
1470788|NCT00702845|Secondary|Number and Quality of Oocytes Assessed Prior to ICSI (Restricted to Participants With ICSI Only)|The number of oocytes used for ICSI was assessed and categorized based on their quality (i.e., metaphase I oocytes, metaphase II oocytes, and germinal vesicles stage oocytes).|Up to 36 hours after administration of hCG|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who underwent ICSI.|||Number of oocytes||Standard Deviation|Mean
1470789|NCT00702845|Secondary|Number and Size Distribution of Follicles During Stimulation and on the Day of hCG Administration|For each participant, the number of follicles ≥11 mm, ≥15 mm, and ≥17 mm, documented by ultrasonography on defined days during the treatment cycle, was calculated.|Predose up to day of hCG administration (up to a maximum total duration of 19 stimulation days, including day of hCG administration)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Follicles||Standard Deviation|Mean
1470790|NCT00702845|Secondary|Serum Inhibin-B Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum inhibin-B were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||pg/mL||Full Range|Median
1470792|NCT00702845|Secondary|Serum Estradiol (E2) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum E2 were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||pmol/L||Full Range|Median
1470793|NCT00702845|Secondary|Serum Lutenizing Hormone (LH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum LH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||IU/L||Full Range|Median
1470794|NCT00702845|Secondary|Serum Follicle Stimulating Hormone (FSH) Levels (Restricted to Participants With hCG Injection)|Blood samples for assessment of serum FSH were taken prior to injection on Stimulation Day 1, Day 3, Day 5, Day 8, Day of hCG, Day of ET, at the visit two weeks after ET.|Predose up to 2 weeks after ET (up to maximum of 6 weeks)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||IU/L||Full Range|Median
1470795|NCT00702845|Secondary|Total Duration of Stimulation (Days)|Total duration of stimulation was defined as the number of days from first drug administration up to and including the Day of hCG administration.|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Days||Full Range|Median
1470796|NCT00702845|Secondary|Number of Days Treated With recFSH|Numbers of days treated with recFSH was defined as the total number of days participants received recFSH (excluding coasting days) until they reached the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||Days||Full Range|Median
1470797|NCT00702845|Secondary|Total Dose of recFSH Administered From Day 8 Onwards|Total dose of recFSH (IU) needed from Stimulation Day 8 onwards to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|Stimulation Day 8 of COS cycle up to day of hCG administration (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||International Unit (IU)||Full Range|Median
1470798|NCT00702845|Secondary|Total Dose of recFSH Administered|Total dose of recFSH (IU) administered was defined as the total amount of recFSH needed by participants to reach the criterion for administration of hCG (at least 3 follicles >=17mm).|One COS cycle (up to a maximum total duration of 19 stimulation days)|Participants from the ITT Group (consisting of all randomized participants who received corifollitropin alfa or recFSH) who received hCG.|||International Unit (IU)||Full Range|Median
1470799|NCT00702845|Primary|Number of Cumulus-oocyte-complexes Retrieved, Per Attempt|The primary efficacy parameter was defined as the number of cumulus-oocyte-complexes retrieved from participants in a controlled ovarian stimulation (COS) cycle for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). For participants who did not have cumulus-oocyte-complex retrieval, the number retrieved was set to zero.|One COS cycle with cumulus-oocyte-complex retrieval (up to a maximum total duration of 21 days)|Intent-to-Treat (ITT) Group, which consisted of all randomized participants who received corifollitropin alfa or recFSH.|||Number of cumulus-oocyte-complexes||Standard Deviation|Mean
1470800|NCT00702780|Primary|% Change of Whole Brain Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.|||percentage of change||Standard Deviation|Mean
1470801|NCT00702780|Primary|% Change of Hippocampus Volume||52 weeks|The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.|||percentage of change||Standard Deviation|Mean
1470802|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 8 (84 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1470803|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 7 (72 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1470804|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 6 (60 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1470805|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 5 (48 Wks) - 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1470806|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 4 (36 Wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1471044|NCT00701090|Secondary|Change From Baseline in Body Weight at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|All patients who took at least one dose of study therapy and had body weight measurements at both baseline and Week 30.|||Kilograms||95% Confidence Interval|Least Squares Mean
1470808|NCT00702754|Secondary|Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms|7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms|Session 2 (12 wks) - 4 weeks post-injection compared to baseline|safety population/Intent to Treat|||points on a scale||Standard Deviation|Mean
1470809|NCT00702754|Primary|Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms|7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms|Session 1 - Time 0, 4 weeks post-injection compared to baseline|Safety Population/Intent to Treat|||points on a scale||Standard Error|Mean
1470810|NCT00702715|Secondary|Time to Recovery of T4/T1 Ratio to 0.7|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
1470811|NCT00702715|Secondary|Time to Recovery of the T4/T1 Ratio to 0.8|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
1470812|NCT00702715|Primary|Time to Recovery of the T4/T1 Ratio to 0.9.|Neuromuscular functioning was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.|start of administration of sugammadex to recovery from neuromuscular blockade|Analysis performed using the Intent-to-Treat (ITT) Population, which consisted of all treated subjects who had at least one efficacy measurement.|||seconds||95% Confidence Interval|Geometric Mean
1470813|NCT00702702|Primary|Change in Hemoglobin vs Placebo|Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3|3 months|Study prematurely terminated for safety reasons||||||
1470814|NCT00702689|Secondary|Change in Immunosuppression|Change in immunosuppression was defined by an increase or decrease in steroid use form baseline.|6 months|Pred:prednisone; tacro:tacrolimus; MPred:methylprednisolone; siro:sirolimus; and MMF:mycophenolate mofetil|||participants|||Number
1470815|NCT00702689|Secondary|Lung Function Score at Baseline and 6 Months|Lung function was graded by the National Institutes of Health Chronic Graft Versus Host Disease organ response criteria. The Lung function score = forced expiratory volume 1 (FEV1) score + carbon monoxide diffusing capacity (DLCO) score, with a possible range of 2 (better outcome)-12 (worst outcome). The percent predicted FEV1 and DLCO (adjusted for hematocrit but not alveolar volume) should be converted to a numeric score as follows: >80% =1; 70-79% = 2; 60-69% = 3; 50-59% = 4; 40-49% = 5; <40% = 6.|Baseline and 6 Months||||units on a scale|||Number
1470816|NCT00702689|Secondary|Total Chronic Graft Versus Host Disease (cGVHD) Provider Global Rating Score at Baseline and 6 Months|The provider global rating is a physician impression of severity of cGVHD symptoms from a scale of zero (no symptoms) to 10 (most severe GVHD symptoms possible).|Baseline and 6 months||||Provider Global Rating Score|||Number
1470817|NCT00702689|Secondary|Total Skin Score at Baseline and 6 Months|Total skin score was graded by the National Institutes of Health Consensus Criteria. Skin score was calculated by dividing the total score by seven domains (skin, eye, oral, joint, gastrointestinal, hepatic, pulmonary) in men and 8 domains in women (previous domains noted plus gynecologic). Total skin score is a percentage of body surface area (BSA) involvement (range 0-100%). It was calculated from the sum of moveable body surface BSA and non-moveable BSA. Higher numbers = greater body surface area affected.|Baseline and 6 Months||||units on a scale|||Number
1470818|NCT00702689|Secondary|Average Percentage Change in Range of Motion (ROM) Deficit|One or more joints were assessed for ROM deficit by a physiatrist with expertise in graft versus host disease and joint ROM.|6 months|This outcome is the average percentage change in ROM deficit among 13 evaluable patients based on each patients baseline range of motion deficit compared to his/her ROM deficit at 6 months.|||Percent change||Inter-Quartile Range|Mean
1470819|NCT00702689|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|41 months, 27 days||||Participants|||Number
1470820|NCT00702689|Primary|Primary Range of Motion (ROM) Response|Progressive disease is defined as joint ROM: decrease of >25% in composite ROM score on 2 consecutive evaluations at least 2 weeks apart, but not greater than 4 weeks apart or steroid pulse: >1 steroid pulse per 3 month period if administered for sclerotic-type chronic graft versus host disease (ScGVHD). Response is joint ROM: increase of >25% in composite ROM score. Maximal response is a response with no further improvement over 2 sequential 3-month evaluations. Stable disease does not meet the criteria for progression, response, or maximal response.|6 months||||participants|||Number
1470821|NCT00702689|Primary|Percent Change in Absolute Range of Motion (ROM) From Baseline to 6 Months|A change in ROM is 25% or greater from baseline. A partial response required improvement in 25% or more in ROM. Progression required 25% or greater loss of ROM.Patients with negative values in the Table are those who lost ROM. Percent improvement in ROM for 1-3 target joints. For patients with >1 target joint, the average ROM improvement was calculated. The average percentage change in ROM deficit from baseline to 6 months was obtained based on the number of degrees of ROM change (6 months)/total ROM deficit (baseline) at each joint.|6 months||||Percent change from baseline|||Number
1470822|NCT00702650|Secondary|Change From Baseline to Endpoint in Draize Score|Draize score is a measurement of skin irritability of the application site based on erythema/eschar and oedema. Erythema/eschar scoring ranges from 0 (no erythema) to 4 (severe erythema [beet redness] to slight eschar formation [injuries in depth]). Oedema scoring ranges from 0 (no oedema) to 4 (severe oedema [raised more than 1 millimeter and extending beyond area of exposure]. The total Draize score ranges from 0 to 8.|Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.|||units on a scale||Standard Deviation|Mean
1470823|NCT00702650|Secondary|Change From Baseline to Endpoint in Haematocrit|Haematocrit: percentage of total blood volume made up of blood cells|Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||percentage of red blood cells||Standard Deviation|Mean
1470824|NCT00702650|Secondary|Change From Baseline to Endpoint in Haemoglobin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||g/dL||Standard Deviation|Mean
1470825|NCT00702650|Secondary|Change From Baseline to Endpoint in Estradiol||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||pg/mL||Standard Deviation|Mean
1470826|NCT00702650|Secondary|Change From Baseline to Endpoint in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||mIU/mL||Standard Deviation|Mean
1470827|NCT00702650|Secondary|Change From Baseline to Endpoint in Prostate Specific Antigen (PSA)||Baseline, Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120.|||ng/mL||Standard Deviation|Mean
1470828|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Glucose||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||mg/dL||Standard Deviation|Mean
1470829|NCT00702650|Secondary|Change From Baseline to Endpoint in Fasting Insulin||Baseline, up to Day 120|Participants enrolled in the study who had a baseline and a measurement at endpoint: Day 120, follow-up, or early withdrawal.|||uIU/mL||Standard Deviation|Mean
1470830|NCT00702650|Secondary|Change From Baseline to Endpoint in the 36-Item Short-Form Health Survey (SF-36)|The SF-36 Health Status Survey is a generic, health-related scale assessing subjects’ quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||units on a scale||Standard Deviation|Mean
1470831|NCT00702650|Secondary|Change From Baseline to Endpoint in Psychosexual Daily Questionnaire|Questions included: Sexual Desire (0=none to 7=very high), Overall Sexual Activity Score (calculated as average of weekly values on scale from 0=none to 7=Frequent), Erection Maintained for Satisfactory Duration (0=not satisfactory to 7=very satisfactory), and Positive and Negative Mood (individual mood variables on scale from 0=Not at all true to 7=very true). Positive mood: sum of 4 positive mood variables-alert, full of pep/energetic, friendly, and well/good (range from 0-28). Negative mood: sum of 5 negative mood variables-angry, irritable, sad/blue, tired, and nervous (range from 0-35).|Baseline, Day 120|All participants who received at least one dose of study drug, had baseline and on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||units on a scale||Standard Deviation|Mean
1470832|NCT00702650|Secondary|Percentage of Participants With Minimum Concentration (Cmin) <300 ng/dL|Cmin is the minimum observed serum concentration (<300 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1470833|NCT00702650|Secondary|Percentage of Participants With Cmax >2500 ng/dL|Cmax is the maximum observed serum concentration (>2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1470834|NCT00702650|Secondary|Percentage of Participants With Cmax Between 1800 and 2500 ng/dL|Cmax is the maximum observed serum concentration (between 1800 and 2500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1470835|NCT00702650|Secondary|Percentage of Participants With Maximum Serum Concentration (Cmax) >1500 ng/dL|Cmax is the maximum observed serum concentration (>1500 ng/dL) during the 24 hour period on Day 120.|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit.|||percentage of participants|||Number
1470836|NCT00702650|Primary|Percentage of Participants With 24-Hour Average Concentration [Cavg(0-24h)] Total Testosterone Within Normal Range at Day 120|Cavg(0-24) is the average serum concentration calculated over the 24 hour period on Day 120. Calculated as the AUC(0-24) divided by 24 hours. Normal range for Total Testosterone was defined as 300 - 1050 nanograms per deciliter (ng/dL).|Day 120|All participants who received at least one dose of study drug, had on-treatment data for at least one efficacy variable, and completed the Day 120 visit. Participants were also included if they withdrew prior to Day 120 because of adverse event or lack of efficacy (considered as treatment failures).|||percentage of participants||95% Confidence Interval|Number
1470837|NCT00702624|Primary|Number of Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Live born infants|||Number
1471045|NCT00701090|Secondary|Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30||Week 0 to Week 30|All patients who took at least one dose of study therapy.|||Percentage of Participants|||Number
1470838|NCT00702624|Primary|Number of Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Live born infants|||Number
1470839|NCT00702624|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Participants|||Number
1470840|NCT00702624|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa or recFSH on base study P05690 (NCT00702845) and who enrolled on the follow-up study.|||Participants|||Number
1470841|NCT00702624|Primary|Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.|From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.|||Percentage of participants|||Number
1470842|NCT00702546|Secondary|Percentage of Participants With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1470843|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1470844|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1470845|NCT00702546|Secondary|Percentage of Participants in Follow up Study With an Ecotopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711|||Percentage of participants|||Number
1470846|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, defined as the presence of at least one fetus with heart activity as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in follow up study P05711 with vital pregnancy|||Percentage of participants|||Number
1470847|NCT00702546|Secondary|Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, defined as the presence of at least one gestational sac as assessed by USS or Doppler, or confirmed by live birth.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants in follow up study P05711 with a clinical pregnancy|||Percentage of participants|||Number
1470848|NCT00702546|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|Cumulative ongoing pregnancy rate was defined as 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base study P05690 (NCT00702845) or after one or more FTET cycles in follow up study P05711 following cryopreservation, divided by the total number of subjects that started treatment in base study P05690.|Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711|Intent-to-Treat (ITT) group from base study P05690 (NCT00702845), which consisted of randomized participants who were treated with corifollitropin alfa or recFSH.|||Percentage of participants|||Number
1470849|NCT00702520|Primary|Take-Home Baby Rate|The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).|Birth of a one or more live babies (Up to 1 year)|Participants treated with Corifollitropin alpha in the base study (P05788, 38833).|||Percentage of participants|||Number
1471437|NCT00698581|Secondary|The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study||Baseline through Re-conversion (approximately 31 weeks)|The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.|||Participants|||Number
1470850|NCT00702520|Primary|Number of Infants Experiencing SAEs|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1470851|NCT00702520|Primary|Number of Infants Experiencing AEs|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1470852|NCT00702520|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|"An AE or suspected adverse reaction is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1470853|NCT00702520|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.|Up to 1 Year|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in the base study P05690 (NCT00702845) and who enrolled in the follow-up study (P05783, 38834, NCT00702520).|||Participants|||Number
1470854|NCT00702507|Secondary|Number of Participants With Mycological Cure of First to Third Recurrent Episodes|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
1470855|NCT00702507|Secondary|Number of Participants With Clinical Cure of First to Third Recurrent Episodes|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clinical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
1470856|NCT00702507|Secondary|Number of Participants With Overall Cure (OC) of First to Third Recurrent Episodes (RE)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide and culture results) at TOC visit for initial episode (ep.) to third ep. Participants (par) who had OC were categorized as Successes; those without OC were categorized as Failures (discontinued/lost to follow-up par were also failures). A RE is not temporally associated with a prior episode (PE) irrespective of whether the PE involves continuing treatment with study medication."|Test-of-cure (TOC) visit (Day 14) of first to third recurrent episodes (up to approximately 1 year and 7 months)|MITT Population: only those participants with confirmed recurrence were analyzed|||participants|||Number
1470857|NCT00702507|Secondary|Clinical Evaluations Using Change From Baseline in the Dermatitis Severity Index Score at Day 14 of the Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions). Change from baseline=baseline value minus Day 14 value. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.|||scores on a scale||Full Range|Median
1470858|NCT00702507|Secondary|Clinical Evaluations Using the Diaper Dermatitis Severity Index Score for Initial Treatment Episode|The diaper dermatitis severity index score was calculated as the sum of severity grades for each parameter evaluated (erythema, papules or pustules, and erosions) for the initial treatment episode. The maximum score possible for the diaper dermatitis severity index is 8. Rating scale for Erythema: 0 (none to trace), 1 (mild [pink]), 2 (moderate [red]), 3 (severe [beefy red]). Rating scale for Papules or Pustules: 0 (none to trace [0]), 1 (few [1-10]), 2 (multiple [11-20]), 3 (many [21-40]), 4 (abundant [more than 40]. Rating scale for Erosions: 0 (absent), 1 (present).|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population. Participants with missing data were not included in this analysis.|||scores on a scale||Full Range|Median
1471183|NCT00700401|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.|At week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1470859|NCT00702507|Secondary|Number of Participants With Mycological Cure|"Participants were evaluated for mycological cure, which was defined as mycological eradication with negative KOH and culture results. Participants who had mycological cure were categorized as Successes; those without mycological cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population|||participants|||Number
1470860|NCT00702507|Secondary|Number of Participants With Clinical Cure|"Participants were evaluated for clinical cure, which was defined as therapeutic cure with total resolution of signs and symptoms (i.e., no clinical signs of infection). Participants who had clinical cure were categorized as Successes; those without clianical cure were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|MITT Population|||participants|||Number
1470861|NCT00702507|Primary|Number of Participants With Overall Cure (OC)|"OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide [KOH] and culture results). Participants who had OC were categorized as Successes; those without OC were categorized as Failures. Any discontinued or lost to follow-up participant was also considered a failure."|Test-of-cure visit (Day 14) of initial treatment episode|Modified Intent-to-Treat (MITT) Population: all participants who were dispensed study drug and had demonstrated clinical symptoms of diaper dermatitis (DD) (DD severity index score of 4-8; clinical erythema grade of >=2 [see outcome measure #4 for a description]) and confirmed Candida species (positive baseline KOH and culture for Candida species)|||participants|||Number
1470862|NCT00702468|Secondary|Carer Global Impressions of Change for Ease of Transfer|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject’s general functional abilities changed?”~How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35||||paticipants|||Number
1470863|NCT00702468|Secondary|Carer Global Impressions of Change for Functional Ability|"The main carer will be asked to assess the change in the subject’s condition at the end of the study (completion or withdrawal). It consists of 2 question which is rated on a seven-point scale: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better. The carer will be asked since visit 2 (baseline):~How has the subject’s general functional abilities changed?”~How has the subject’s ease of transfer?” Not all subjects had carers; a total of 18 subjects from each treatment, of which 10 from Sativex and 14 from placebo completed it."|Day 35||||paticipants|||Number
1470864|NCT00702468|Secondary|Subject Global Impressions of Change.|"At baseline subjects will write a brief description of their spasticity caused by MS and how it affects them emotionally, physically and their ability to function with day to day activities. This will be used to aid their memory before they answer the following question which is rated on a seven-point scale.~“Please assess the change in your spasticity due to MS since immediately before receiving the first course of study treatment (Baseline) using the scale below” The markers are: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better."|Day 35||||participants|||Number
1470865|NCT00702468|Secondary|Daily Sleep Disruption NRS|Subjects will be asked: ”On a scale of 0-10 please indicate how your spasticity disrupted your sleep last night” with the anchors 0 = ‘did not disrupt sleep’, 10 = ‘completely disrupted (unable to sleep at all)’.|Week 1- Week 5|It is important to note that 16 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.|||points on scale||Standard Deviation|Mean
1470866|NCT00702468|Secondary|Timed 10-metre Walk.|The time taken to travel 10 metres.|Week 2 and Week 5|ITT. Only 4 placebo subjects were included in the analysis and 11 of the Sativex subjects. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||Seconds||Standard Deviation|Mean
1470867|NCT00702468|Secondary|Change in Motricity Index|The Motricity Index involves assessing three movements in both the arms and the legs. In the arm the three movements are; pinch grip, elbow flexion and shoulder abduction and the three leg movements are, ankle dorsiflexion, knee extension and hip flexion. The total arm/leg score is then the addition of the score for the three arm/leg movements. One point is then added to each limb score so that the maximum score is 100 points. The higher the score the better the limb movement.|Week 2 and Week 5|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||points on scale||Standard Deviation|Mean
1470868|NCT00702468|Secondary|Change in Modified Ashworth Scale.|"The Modified Ashworth Scale was completed at baseline and at the end of treatment at approximately the same time of day. All 20 muscle groups were assessed for spasticity (using a 0=no increase in muscle tone to 4 scale=affected part rigid in flexion or extensions), to result in a total score out of 80. The higher the score the worse the spasticity is.~The change from baseline to end of study was assessed. The higher the score the better"|Day 7 to Day 28|ITT. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|||score on scale||Standard Deviation|Mean
1470869|NCT00702468|Secondary|Change in Mean Daily Spasticity Severity as Measured on a Spasticity Severity 0-10 Numerical Rating Scale (NRS).|"Spasticity NRS was completed daily by answering the following question:~“On a scale of ‘0 to 10’ please indicate the average level of your spasticity over the last 24 hours” with the anchors: 0 = ‘no spasticity’ and 10 = ‘worst possible spasticity’. The change in mean spasticity severity NRS from baseline to end of study (last seven days)was calculated. A negative change from baseline indicates an improvement in spasticity."|Baseline (Week 1) to Week 5|It is important to note that 17 of the placebo subjects withdrew from the study early. All subjects were accounted for in this analysis by use of a last-observation-carried-forward approach.|||points on scale||Standard Deviation|Mean
1472958|NCT00685295|Primary|Time to Analgesia|Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)|60 minutes||||minutes||Inter-Quartile Range|Median
1470870|NCT00702468|Primary|Number of Subjects Who Experience Treatment Failure.|The time to treatment failure was calculated as the number of days from the first day of treatment up to the day of treatment failure. The day of treatment failure was the earliest of:the day of premature cessation of study medication;the first day of the longest period, ending on the last day of treatment, where the mean spasticity NRS had increased by at least 20% and at least 1 unit from the treatment baseline; the day of a clinically relevant increase in anti-spasticity or disease modifying medication. The number of subjects who failed treatment were calculated.|Week 1- Week 5||||Participants|||Number
1470871|NCT00702403|Secondary|Relapse|The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia|1 and 3 years|Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.|||Participants|||Count of Participants
1470872|NCT00702403|Secondary|Patients Alive With Out Relapse|The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year|Up to 1 year|Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data|||Participants|||Count of Participants
1470873|NCT00702403|Secondary|Survival|The proportion of study participants alive at 1, 2 and 3 years|Up to 3 years|Overall Survival (complete follow-up is available out to three years for all patients)|||Participants|||Count of Participants
1470874|NCT00702403|Secondary|The Proportion of Patients at 1 Year With Treatment Efficacy Success|To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, >5% BCR/ABL in marrow by fluorescent in situ hybridization, or >1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).|Up to 1 year|"The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by intention to treat), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality."|||Participants|||Count of Participants
1470875|NCT00702403|Primary|Number of Participants With Treatment Safety Failure|Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.|Up to 365 days post-transplant|"Critical to note are two intention-to-treat populations: the 1st (N=57) at time of consent, evolved into the second ITT population (N=40), because 17 subjects lost eligibility to begin relapse prophylaxis at engraftment. A 2nd wave of discontinuations occurred at or after Day 81 when all patients were to be switched from imatinib to nilotinib."|||Participants|||Count of Participants
1470876|NCT00702377|Primary|Corneal Staining|Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42||||Units on a scale||Standard Deviation|Mean
1470877|NCT00702377|Primary|Conjunctival Staining|Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye’s surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.|Day 0, Day 7, Day 14, Day 28, Day 42||||Units on a scale||Standard Deviation|Mean
1470878|NCT00702377|Primary|Tear Break-up Time|Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.|Day 0, Day 7, Day 14, Day 28, and Day 42||||seconds||Standard Deviation|Mean
1470879|NCT00702364|Secondary|Neurobehavioral Functioning Inventory Depression Subscale|"Neurobehavioral Functioning Inventory (NFI) was developed as a clinical and research tool to quantify a variety of post-injury behaviours and symptoms characteristic of neurologic disability and encountered in daily life. The inventory is comprised of 76 items organized into six analytically derived factor scales: Depression, Somatic, Memory/Attention, Communication, Aggression, and Motor. Respondents are asked to rate items as occurring never, rarely, sometimes, often, or always. Using the standardized scoring procedures outlined in the NFI Manual, T-scores were calculated for the Depression sub-scale. Lower T-score indicates less depressive symptomotology."|Post treatment||||T-score||95% Confidence Interval|Mean
1470880|NCT00702364|Primary|Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale Summary Score|The Adult ADHD Self-Report Scale (ASRS-v1.1) is a self-report questionnaire that consists of questions involving the 18-items of the The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV- Text Revision (TR) criteria for ADHD that rate symptoms on a Likert scale ranging from 0-4 based on the frequency of symptoms (“never”, “rarely”, “sometimes”, “often”, and “very often”). A previous study of the ASRS found the self-report to be both valid (Cronbach’s alpha =.88) and reliable (ICC=.84). Scores on the 18 items were summed for a total ASRS score.|Post treatment||||units on a scale||95% Confidence Interval|Mean
1470881|NCT00702364|Primary|Stroop Test Interference T-score|The Stroop Color and Word Test is frequently used to study deficits of attention and executive function in individuals with TBI, and has adequate test-retest reliability. At each administration, the following scores were obtained, Word Reading, Colour Naming and Interference. Raw scores were converted to demographically-adjusted T-scores using Golden and Freshwater norm.|Post treatment||||T-score||95% Confidence Interval|Mean
1473971|NCT00677820|Secondary|Number of Subjects Reporting Any Adverse Event (AE) Post-treatment||Days 0-7|Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.|||participants|||Number
1470882|NCT00702364|Primary|CDR Power of Attention|"Cognitive Drug Research (CDR) Computerized Cognitive Assessment System [19] is comprised of a battery of computer-controlled tasks administered on a laptop computer with parallel forms of the tests being presented on each testing session. The Power of Attention factor of the CDR was selected as the primary outcome measure because of its strong psychometric properties in other drug studies with cognitively compromised populations.~Instead of utilizing a t-test to compare treatment and control groups, treatment and control groups for both primary and secondary outcomes were compared utilizing an analysis of covariance (ANCOVA) model in which repeat baseline measures taken on each respective outcome served as a covariate. This method controls for any differences that may exist between the groups at baseline. Model assumptions for conducting an ANCOVA were investigated for all primary and secondary analyses, where no violations of model assumptions were detected. Additionally,"|Post treatment||||msec||95% Confidence Interval|Mean
1470883|NCT00702338|Primary|Number of Infants With SAEs During Follow-up|An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.|||participants|||Number
1470884|NCT00702338|Primary|Number of Infants With AEs During Follow-up|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study|Follow-up safety analysis was performed on the fetuses/infants delivered by the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. There were no other eligible infants to be evaluated for safety.|||participant|||Number
1470885|NCT00702338|Primary|Number of Mothers With Serious AEs (SAEs) During Follow-up|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.|||participants|||Number
1470886|NCT00702338|Primary|Number of Mothers With Adverse Events (AEs) During Follow-up|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)|Follow-up safety analysis was performed on the one expectant mother who received corifollitropin alfa + hCG on the base study P05693 (NCT00697255) and who enrolled on the follow-up study. No mothers receiving corifollitropin alfa + recFSH in the base study were enrolled in this follow-up study or included in safety analyses.|||participants|||Number
1470887|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis|Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Participants in the Intent-to-Treat group (ITT) in base study P05693 (NCT00697255) that received bolus injection of hCG.|||percentage of participants|||Number
1470888|NCT00702338|Primary|Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined|The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.|From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)|Intent-to-Treat group (ITT) consisted of all treated participants in base study P05693 (NCT00697255): 5 participants in Stage Ia and 3 participants in Stage Ib.|||percentage of participants|||Number
1470889|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|1 week||||Participants|||Number
1470890|NCT00702325|Secondary|Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away|1 week||||Participants|||Number
1470891|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.|12 week||||Participants|||Number
1470892|NCT00702325|Secondary|Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)|There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
1470893|NCT00702325|Secondary|Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment|There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.|12 weeks||||Proportion of Participants|||Number
1470894|NCT00702325|Secondary|Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])|Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1470895|NCT00702325|Secondary|Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ)|Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away|12 week||||Participants|||Number
1470896|NCT00702325|Secondary|Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period|Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
1470897|NCT00702325|Secondary|Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period|Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
1470898|NCT00702325|Secondary|Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period|Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||percentage of days||Standard Deviation|Mean
1470899|NCT00702325|Secondary|Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period|Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
1470900|NCT00702325|Secondary|Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
1470901|NCT00702325|Secondary|Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period|Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Puffs/day||Standard Deviation|Mean
1470902|NCT00702325|Secondary|Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period|Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Number of nights||Standard Deviation|Mean
1470903|NCT00702325|Secondary|Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1483827|NCT00596011|Secondary|Median Serum Total Prostatic Specific Antigen (tPSA)|Median ng/mL serum tPSA post treatment, per treatment arm.|12 months|All participants|||ng/mL||95% Confidence Interval|Median
1470904|NCT00702325|Secondary|Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1470905|NCT00702325|Secondary|Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period|Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Scores on a scale||Standard Deviation|Mean
1470906|NCT00702325|Secondary|Number of Withdrawals Due to a Predefined Asthma Event|Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)|12 weeks||||Participants|||Number
1470907|NCT00702325|Secondary|Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry|Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)|12 weeks||||Participants|||Number
1470908|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period|Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/second||Standard Deviation|Mean
1470909|NCT00702325|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1470910|NCT00702325|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1470911|NCT00702325|Secondary|Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters/minute||Standard Deviation|Mean
1470912|NCT00702325|Primary|Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period|Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period|Baseline to 12 weeks|Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.|||Liters||Standard Deviation|Mean
1470913|NCT00702299|Secondary|Pharmacokinetics (Mean Cmax, ug/mL)for Different Dosages of Pemetrexed|Cmax levels were found through plasma collected between 0.5 to 4 hours and at 24 hours after initiation of intraperitoneal administration|18 months||||ug/mL||Standard Deviation|Mean
1470914|NCT00702299|Secondary|Overall Survival||Average Length of follow-up 788 days||||Days||Full Range|Median
1470915|NCT00702299|Secondary|Progression-free Survival at 18 Months as Assessed by Cancer Antigen 125|Progression was evaluated with posttreatment CT scans and measured changes in cancer antigen 125 levels 6 months after the initiation of the treatment regimen, or within one month after discontinuation of treatment if stopped early. Cancer antigen 125 response in evaluable patients (N=13) was analyzed using the modified Gynecologic Cancer Intergroup (GCIG) criteria. There was one evaluable patient by Response Evaluation Criteria in Solid Tumors(RECIST) criteria|18 months||||% of participants|||Number
1470916|NCT00702299|Primary|Patients Experienced Grade >=3 Toxicity at Dose Level 5 (1,000 mg/m2 IP Pemetrexed)|Toxicity was assessed by NCI Common Toxicity Criteria for Adverse Effects v3.0|18 months||||participants|||Number
1470917|NCT00702299|Primary|Patients That Completed at Least 6 Courses of Therapy of Pemetrexed Along With Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)at the Determined Maximum Tolerated Dose|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the Maximum Tolerance Dose (MTD) would be determined to be the next lower dose level.|18 months||||% of participants|||Number
1470918|NCT00702299|Primary|Maximum-tolerated Dose of Pemetrexed With a Day 2 i.p. Cisplatin (75 mg/m2) and Day 8 i.p. Paclitaxel (60 mg/m2)|If none of the initial 3 patients on a dose level experienced a dose-limiting toxicity (DLT) after the first cycle of therapy, then the dose was escalated to the next level. If 2 or more patients on any dose level experienced a DLT, then the maximum tolerated dose would be determined to be the next lower dose level.|18 months||||mg/m2|||Number
1470919|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ongoing Pregnancy|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed at live birth. Ongoing pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
1470920|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Vital Pregnancy|A vital pregnancy is the presence of at least one fetus with heart activity. Vital pregnancies were calculated per attempt, meaning if any stage of IVF treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
1470921|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Clinical Pregnancy|A clinical pregnancy is the presence of at least gestational sac or confirmed by live birth. Clinical pregnancies were calculated per attempt, meaning if any stage of in vitro fertilization (IVF) treatment was not achieved, zero values were imputed.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study, that had an embryo transfer in the respective cycle.|||Percentage of participants|||Number
1470922|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With an Ectopic Pregnancy|An ectopic pregnancy is where the embryo implants outside the uterus. Ectopic pregnancies were calculated per total number of participants started in FTET.|After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)|Participants enrolled in P05716 Follow Up study.|||Percentage of participants|||Number
1470923|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Vital Pregnancy|Miscarriages were calculated per vital pregnancy, meaning the presence of at least one fetus with heart activity.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a vital pregnancy.|||Percentage of participants|||Number
1470924|NCT00702273|Secondary|Percentage of Participants in Follow up Trial With a Miscarriage Per Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, meaning the presence of at least one gestational sac or confirmed by live birth.|After one or more FTET cycles, up to day of miscarriage (up to 1 year)|Participants enrolled in P05716 Follow Up study that had a clinical pregnancy.|||Percentage of participants|||Number
1470925|NCT00702273|Primary|Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)|An ongoing pregnancy is the presence of at least one fetus with heart activity at least 10 weeks after embryo transfer or confirmed by live birth.The cumulative ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy either immediately after embryo transfer in base Trial P05787 (NCT00696800), or after one or more FTET cycles in follow-up Trial P05716 following cryopreservation, divided by the total number of participants that started treatment in base Trial P05787 (NCT00696800). Participants who did not have cryopreserved embryos, or embryo transfers in the FTET cycle(s), were considered 'not pregnant'.|Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial|ITT group from base trial P05787, consisting of randomized participants who were treated with Corifollitropin Alfa or recFSH.|||Percentage of participants|||Number
1470926|NCT00702234|Primary|Number of Live Born Infants Experiencing SAEs|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1470927|NCT00702234|Primary|Number of Live Born Infants Experiencing AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Up to 12 weeks after birth|Follow-up safety analysis was performed on live born infants delivered by expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1470928|NCT00702234|Primary|Number of Expectant Mothers Experiencing Serious AEs (SAEs)|An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1470929|NCT00702234|Primary|Number of Expectant Mothers Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From approximately 10 weeks after fresh ET in base study P05714 up to birth of infant (up to approximately 6 months)|Follow-up safety analysis was performed on expectant mothers who received corifollitropin alfa in base study P05714 (NCT00696878) and who enrolled in the follow-up study.|||participants|||Number
1470945|NCT00701935|Secondary|Change in Fasting Plasma Glucose From Baseline to 6 Months|Change in Fasting plasma glucose|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Analysis done only for patients with measurement at Month 6.|||mmol/L||Standard Error|Least Squares Mean
1470930|NCT00702234|Primary|Percentage of Women With Ongoing Pregnancy After a Corifollitropin Alfa COS Cycle in Base Study and ≥1 Live Born Infant During Follow-up (Live Birth Rate)|The live birth rate was defined as the number of participants who had an ongoing pregnancy after a corifollitropin alfa COS cycle in base study P05714 (NCT00696878) and who had at least one live born infant during follow-up, divided by the number of participants treated in the base study. For this analysis, it was assumed that any participants with ongoing pregnancy after a COS cycle in base study who did not enroll in follow-up study P05715 had no live born infants.|Up to approximately 32 months after first dose of corifollitropin alfa in base study P05714 (NCT00696878)|Participants administered corifollitropin alfa in base study P05714 (NCT00696878)|||percentage of participants|||Number
1470931|NCT00702221|Primary|Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)||baseline to 8 weeks|study prematurely terminated|||mmHg||Standard Error|Mean
1470932|NCT00702208|Primary|Kappa Coefficient|Kappa comparing clinician-collected cytology result to self-lavage cytology result|1-3 months between 2 specimen collections||||kappa coefficient for paired specimens||95% Confidence Interval|Number
1470933|NCT00702208|Secondary|Outcome: Acceptability of Device|On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening|cross-sectional - asked at time of Screener use|For acceptability, 197 women used the device; 30 of these women did not have valid gold standard results but did respond to acceptability, thus for acceptability endpoint the sample size is 197 (while the sample size is 167 for sensitivity, specificity and kappa analyses due to insufficient sepcimens /loss to follow-up for colposcopy).|||units on a scale||Inter-Quartile Range|Median
1470934|NCT00702208|Primary|Sensitivity and Specificity|"We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.~The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints."|1-3 months between 2 specimen collections||||% of participants correctly diagnosed||95% Confidence Interval|Number
1470935|NCT00702143|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||SUVR||Standard Deviation|Mean
1470936|NCT00702143|Secondary|Proportion of Positive Florbetapir-PET Scans|Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||percentage of amyoid positive scans|||Number
1470937|NCT00702143|Primary|Qualitative Amyloid Image Assessment|Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection|One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.|||participants|||Number
1470938|NCT00701935|Secondary|Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event|All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration < 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value < 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||hypoglycemia rate/year||Standard Error|Mean
1470939|NCT00701935|Secondary|Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months|Change in HDL cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
1470940|NCT00701935|Secondary|Change in Triglycerides From Baseline to 6 Months|Change in triglycerides|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
1470941|NCT00701935|Secondary|Change in Total Cholesterol From Baseline to 6 Months|Change in total cholesterol|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||mmol/L||Standard Error|Least Squares Mean
1470942|NCT00701935|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months|Change in Diastolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1470943|NCT00701935|Secondary|Change in Systolic Blood Pressure From Baseline to 6 Months|Change in Systolic blood pressure|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug.|||mmHg||Standard Deviation|Mean
1470944|NCT00701935|Secondary|Change in Weight From Baseline to 6 Months|Change in weight|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analyzed.|||kg||Standard Error|Least Squares Mean
1471255|NCT00699907|Primary|Colony Stimulating Factor-1 Receptor (CSF-1R) Expression in Ovarian Endosalpingiosis|CSF-1R levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
1470946|NCT00701935|Secondary|Percentage of Patients With HbA1c <=7.0% at 6 Months|Percentage of patients with HbA1c values <= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received.Analysis done only for patients with measurement at Month 6.|||Percentage of patients|||Number
1470947|NCT00701935|Secondary|Change in HbA1c From Baseline to 6 Months|Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received. Last observation (month 6 or early discontinuation) was analysed.|||% change||Standard Error|Least Squares Mean
1470948|NCT00701935|Secondary|Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months|Percentage change in subcutaneous abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
1470949|NCT00701935|Secondary|Percentage Change in Total Abdominal Fat From Baseline to 6 Months|Percentage change in total abdominal fat|baseline, 6 months|Analysis done on the ITT Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
1470950|NCT00701935|Primary|Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months|Percentage change in abdominal visceral fat|baseline, 6 months|Primary analysis done on the Intent To Treat (ITT) Population including all randomized patients receiving at least one dose of study drug according to the treatment the subjects are randomized to regardless of what study drug patients received|||% change||Standard Error|Least Squares Mean
1470951|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal BSAP at Baseline.|||Percentage of participants|||Number
1470952|NCT00701805|Secondary|The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who had abnormal alkaline phosphatase at Baseline.|||Percentage of participants|||Number
1470953|NCT00701805|Other Pre-specified|The Percentage of Participants With Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)|Anytime from Week 13 through Week 53||||Percentage of participants|||Number
1470954|NCT00701805|Secondary|Duration of 2 Consecutive iPTH Values <= 180 pg/mL||From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||days||Standard Deviation|Mean
1470955|NCT00701805|Secondary|Duration of 2 Consecutive Decreases in iPTH >= 50%||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||days||Standard Deviation|Mean
1470956|NCT00701805|Secondary|Change in Mean iPTH||Every week from Baseline through Week 13 and every other week thereafter until Week 53|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||pg/mL||Standard Deviation|Mean
1470957|NCT00701805|Secondary|The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%||Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||Percentage of Participants|||Number
1470958|NCT00701805|Secondary|The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit||From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||Percentage of participants|||Number
1470959|NCT00701805|Secondary|The Mean Change in Intact Parathyroid Hormone (iPTH)||From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)|All subjects who received at least 1 dose of paricalcitol in this study and who were included in the Full Analysis Set.|||picograms/milliliter (pg/mL)||95% Confidence Interval|Mean
1470960|NCT00701805|Primary|The Percentage of Participants With Hyperphosphatemia|The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.|||Percentage of participants|||Number
1470961|NCT00701805|Primary|The Percentage of Participants With of Hypercalcemia|The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.|Anytime during the study through Week 53|All subjects who received at least 1 dose of paricalcitol in this study.|||Percentage of participants|||Number
1470962|NCT00701779|Primary|Prostate Specific Antigen|Prostate Specific Antigen (PSA) taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||ng/mL||Standard Deviation|Mean
1470963|NCT00701779|Primary|Post-void Residual Volume|Post-void residual volume taken at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||mL||Standard Deviation|Mean
1470964|NCT00701779|Primary|Benign Prostate Hyperplasia Impact Index|"Benign prostate hyperplasia Impact Index obtained at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Benign Prostatic Hyperplasia Impact Index asked the following:~Over the past month, how much physical discomfort did any urinary problems cause you? (0-3)~Over the past month, how much did you worry about yoru health because of any urinary problems? (0-3)~Overall, how bothersome has any trouble with urination been during the past month? (0-3)~Over the past month, how much of the time has any urinary problem kept you from doing the kinds of things you usually do? (0-4) 0 indicates no symptoms, high values indicate high frequency of symptoms. Total symptom score range 0-13."|12 months||||units on a scale||Standard Deviation|Mean
1470965|NCT00701779|Primary|Peak Flow Rate (QMax)|Peak flow rate recorded at final study visit (12 month) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.|12 months||||ml/sec||Standard Deviation|Mean
1470966|NCT00701779|Primary|International Prostate Symptom Score|"Reported mean total IPSS values from end of study (12 month visit) to assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior symptomatic improvement to BPH patients.~Questionnaire consisting of seven symptom scores: incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Symptoms are scored on a 5 point scale with 0 representing absence of symptoms and 5 representing the most severe presentation of a symptom.~Total range is from 0-35. The scores are evaluated as such:~0-7: Mild 8-19: Moderate 20-35: Severe"|12 months||||units on a scale||Standard Deviation|Mean
1470967|NCT00701779|Secondary|Reduction of AUR and BPH-related Surgery|To assess efficacy of starting with combination treatment with Dutasteride for one year and Tamsulosin for 3 months with subsequent as needed use of Tamsulosin in providing superior improvement in the clinical outcomes of AUR or BPH-related prostatic surgery to BPH patients.|13 months|||||||
1470968|NCT00701779|Secondary|Economic Impact|To assess the pharmacoeconomic impact on starting with combination therapy with Dutasteride and Tamsulosin with subsequent withdrawal of Tamsulosin.|13 months|||||||
1470969|NCT00701779|Secondary|Safety and Tolerability|To assess safety and tolerability of starting with combination therapy with Dutasteride and Tamsulosin and subsequent elimination of Tamsulosin. Evaluating number of reported adverse events designated as possibly or probably study-drug related.|13 months||||adverse events|||Number
1470970|NCT00701779|Secondary|Health Outcome Measures|To assess the effects of starting with combination therapy with Dutasteride and Tamsulosin and subsequent withdrawal of Tamsulosin on health outcome measures.|13 months|||||||
1470971|NCT00701727|Secondary|High-density Lipoprotein (HDL)|Change from baseline in plasma HDL, measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL HDL||Standard Deviation|Mean
1470972|NCT00701727|Secondary|Low-density Lipoprotein (LDL);|Change from baseline in plasma low-density lipoprotein(LDL), measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL LDL||Standard Deviation|Mean
1470973|NCT00701727|Secondary|Triglycerides (TG)|Change from baseline in plasma triglycerides, measured in fasting blood samples|7 weeks|per protocol, all subjects|||mg/dL TG||Standard Deviation|Mean
1470974|NCT00701727|Secondary|Cholesterol Efflux Rate (Ra Cholesterol)|The efflux, or mobilization, rate of cholesterol from peripheral tissues into the plasma will be measured as mg/kg/hr. An IV infusion of [13C2] cholesterol mixed in 10% Intralipid® and 10 % ethanol is given piggy-backed into normal saline over 20 hours (4pm – 12 noon). This is used to determine rate of appearance (Ra) cholesterol, which will be measured by dilution of infused [13C2] cholesterol during the plateau phase of plasma enrichment (approximately the last 4 hours of the infusion), as well as to provide the plasma cholesterol that will be traced into biliary sterols.|7 weeks|per protocol, all subjects|||mg/kg/hr cholesterol||Standard Deviation|Mean
1470975|NCT00701727|Secondary|de Novo Cholesterol Synthesis (DNC)|Plasma DNC will be measured following the isotope infusion of deuterated water, expressed as %.|7 weeks|per protocol, all subjects|||%/day plasma DNC||Standard Deviation|Mean
1470976|NCT00701727|Secondary|Change From Baseline in Total Cholesterol, From Fasting Plasma Samples|plasma levels of total cholesterol|7 weeks|per protocol, all subjects|||mg/dL total cholesterol||Standard Deviation|Mean
1470977|NCT00701727|Primary|Fecal Excretion of Plasma-derived Cholesterol|"(Fecal excretion of plasma-derived cholesterol):The following measurements will be made following isotope infusion:~The composition of fecal neutral and acidic sterols will be measured as % of total.~The excretion rate of fecal neutral and acidic sterols will be measured as mg/day.~The isotopic enrichment of both fecal neutral and acidic sterols will be measured as atomic percent excess (% APE).~Fecal isotope excretion, or recovery, of plasma-derived cholesterol will be calculated as %/day."|7 weeks|Per Protocol,all subjects|||mg/day cholesterol excreted||Standard Deviation|Mean
1470978|NCT00701714|Secondary|Immunogenicity|Number of participants with antibody formation against Epoetin during treatment period (safety set)|13 weeks||||participants|||Number
1470979|NCT00701714|Primary|Weekly Epoetin Dose|Mean weekly epoetin dose [IU/kg] in study weeks 11-13|weeks 11-13|Full analysis set required: “all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available”. 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.|||IU/kg||Standard Deviation|Mean
1470980|NCT00701714|Primary|Change in Hemoglobin Level|Mean absolute change in hemoglobin (baseline to end of study week 13)|13 weeks|Full analysis set required: “all randomized patients who received at least one dose of the study medication and for whom at least one Hb value after study day 27 was available”. 3 out of 174 patients started in EPO HEXAL group and 6 out of 163 patients started in ERYPO group had no Hb values after study day 27 so they were excluded from analysis.|||g/dL||Standard Deviation|Mean
1471077|NCT00700817|Secondary|Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78|Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmHg||Standard Deviation|Mean
1470981|NCT00701675|Primary|Comparisons of End of Study HAM-A Score Means for Sertraline 50 mg vs Placebo, Sertraline 100 mg vs Placebo, and Sertraline 50 mg vs. Sertraline 100 mg|Least squares (LS) means estimate and p-value from mixed effects model with baseline and site as covariates and Tukey-Kramer adjustment for multiple comparisons Hamilton Rating Scale for Anxiety (HAM-A) is a widely used rating scale for anxiety describes the presence/absence of the severity of anxiety symptoms. It's clinician-rated scale of 14 items rated from 0-4. Generally, total score of <17 is mild anxiety; 18-24 is mild to moderate, and 25 and up is moderate to severe.|11 weeks from baseline|sertraline 50mg group and placebo group each had 2 subjects with missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
1470982|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Vital Signs|Vital signs included heart rate, systolic blood pressure, diastolic blood pressure, and body temperature.|Baseline to Week 25|The SDS comprised all treated patients.|||participants|||Number
1470983|NCT00701662|Secondary|Number of Patients With Clinically Relevant Changes in Laboratory Parameters|Laboratory parameters included hematology, serum chemistry, and urinalysis parameters.|Baseline to Week 25|The SDS comprised all treated patients.|||participants|||Number
1470984|NCT00701662|Secondary|Number of Patients With Local/Injection Site Reactions|All AEs arising from local/injection site reactions.|For the duration of the study, up to Week 25|The SDS comprised all treated patients.|||participants|||Number
1470985|NCT00701662|Secondary|Rate of AEs by Severity and Relatedness|"The rate was the number of AEs over the number of infusions administered. Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The SDS comprised all treated patients.|||AEs per infusion|Participants||Number
1470986|NCT00701662|Secondary|Number of Patients With Adverse Events (AEs) by Severity and Relatedness|"Included all AEs that occurred during the entire study period.~Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities."|For the duration of the study, up to Week 25|The safety data set (SDS) comprised all treated patients.|||participants|||Number
1470987|NCT00701662|Secondary|Overall Health Status at Baseline and Week 25|Overall Health Status was assessed using a Visual Analogue Scale (VAS). Patients were asked to rate their overall health status by placing a mark on a 100 mm VAS, with 0 being the worst imaginable state and 100 being the best imaginable state.|Baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
1470988|NCT00701662|Secondary|Treatment Satisfaction at Baseline and Week 25|Treatment satisfaction was assessed using the Life Quality Index, which comprises 15 items rated on a 7-point scale (1 = worst rating, 7 = best rating) with a possible maximum score of 105. The highest score indicates the highest satisfaction with the impact of treatment on social factors. The 15 items were summarized to 4 scales: treatment interference, therapy-related problems, therapy setting, and treatment costs. The raw scores for these scales were transformed to a score ranging from 0 to 100, with 100 being the best score achievable.|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
1470989|NCT00701662|Secondary|Health-Related Quality of Life at Baseline and Week 25|"Assessed using a questionnaire on patients' satisfaction with current immunoglobulin G (IgG) treatment, treatment at home, and treatment at the hospital/doctor's office. The questions were answered by choosing a number between 1 (extremely good) and 7 (extremely bad).~Note: No patients received IgG treatment at the hospital/doctor's office at Week 25."|At baseline and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||units on a scale||Full Range|Mean
1470990|NCT00701662|Secondary|Mean Motor Function Score at Screening and Week 25|For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst).|Screening and week 25|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||Full Range|Mean
1470991|NCT00701662|Primary|Mean Overall MRC Score at Baseline and Week 24|The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement.|Baseline and week 24|The ITT data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.|||score on a scale||Full Range|Mean
1470992|NCT00701662|Secondary|Change From Baseline to the Completion Visit in Motor Function|"The change in motor function was determined at the completion visit compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method.~For each patient, four specific tasks were defined according to his/her weakened muscle group. The patient had to grade each of the tasks on a 5-point scale ranging from 0 (normal function) to 4 (not possible). The overall motor function score was calculated as the sum of the 4 grades, resulting in a score ranging from 0 (optimal) to 16 (worst). The baseline motor function score was calculated as the mean of the patient's assessments at Screening and Week 1. Negative values for change in motor function score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to the completion visit (up to week 25)|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||95% Confidence Interval|Mean
1471078|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52|Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1470993|NCT00701662|Secondary|Mean Disability Score at Baseline and Week 24|Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability.|Baseline and Week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||Full Range|Mean
1470994|NCT00701662|Secondary|Change From Baseline to Week 24 in Disability|"The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~Disability was measured using a modified Guy’s Neurological Disability Scale, which comprises subscales for upper and lower limb disability. Both subscales comprise 6 grades, numbered from 0 (no upper limb problem/walking is not affected) to 5 (unable to use either arm for any purposeful movements/usually uses a wheelchair indoors). The disability score is calculated as the sum of both subscales, resulting in a score ranging from 0 to 10. A higher disability score indicates greater disability. Negative values for change in disability score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline."|Baseline to week 24|The analysis population comprised the subjects in the ITT data set (ie, all patients treated with the study drug) who had at least one post-baseline value (and if necessary a baseline value).|||score on a scale||95% Confidence Interval|Mean
1470995|NCT00701662|Primary|Change From Baseline to Week 24 in Muscle Strength|"The change in Medical Research Council (MRC) score was determined at week 24 compared to baseline using descriptive statistics and nonparametric, two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one of the eight subjects was from week 13 as week 24 data were not available.~The 200-point MRC sum score is the sum of scores for 20 bilateral (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline."|Baseline to week 24|The Intention-to-Treat (ITT) data set comprised all patients treated with the study drug who had at least one post-baseline measurement for muscle strength.|||score on a scale||95% Confidence Interval|Mean
1470996|NCT00701636|Primary|Mean Daptomycin Concentrations at 12, 18, 24, and 48 h|Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h|Hospital discharge or 7 days, whichever comes first|Based on sample sizes from previously published studies on antibiotic pk for CABG surgery.|||mcg/ml||Standard Deviation|Mean
1470997|NCT00701558|Secondary|Overall Survival|Overall survival was defined as the interval between the day of randomization and the date of death from any cause.|From the time of randomization until death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.|||weeks||95% Confidence Interval|Median
1470998|NCT00701558|Primary|Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the time of randomization until disease progression or death (up to 193 weeks)|ITT population included all participants who were randomized to treatment group.|||percentage of participants|||Number
1470999|NCT00701558|Primary|Time to Disease Progression|Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.|From the time of randomization until disease progression or death (up to 193 weeks)]|Intention to treat (ITT) population included all participants who were randomized to treatment group.|||weeks||95% Confidence Interval|Median
1471000|NCT00701441|Other Pre-specified|Peroxynitrite Deposition in the Vascular Walls|A forearm biopsy will be collected to isolate human microcirculatory endothelial cells. The stain density of peroxynitrite, an indicator of oxidative stress, in the vascular walls is compared between pre-treatment and post treatment patient tissue. Also another comparison is made between pre-treatment and control tissue. The stain density is a software-generated measurement of pixel intensity and is considered to be an arbitrary unit. Higher numbers indicate greater density|baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and flow mediated dilation only.|||stain density units||Standard Error|Mean
1471001|NCT00701441|Primary|Flow Mediated Dilation|A non-invasive test using an ultrasound to measure baseline resting vessel diameter and vessel wall dilation in upper arm post application of an inflated blood pressure cuff for five minutes. The percentage change in vessel wall dilation due to stimulation from the resting vessel diameter will be calculated for each group of participants. The results will be compared relative to each group of participants.|Baseline and 12 weeks|Comparative values analyzed for those with endothelial nitric oxide synthase and nitrotyrosine stain density values only.|||percentage change of vessel diamter||Standard Error|Mean
1471002|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Urine|Plasma samples were assayed for total urine GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal of <0.030 mg/mmoL of creatinine. Number of participants analyzed=participants with both baseline and post-baseline GL-3 urine clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.|||Percent change||Standard Deviation|Mean
1471003|NCT00701415|Secondary|Percent Change From Baseline in GL-3 Clearance From Plasma|Plasma samples were assayed for GL-3 clearance using a validated tandem mass spectrometry with an upper limit of normal plasma GL-3 level of 7.0 μg/mL. Number of participants analyzed=participants with both baseline and post-baseline GL-3 plasma clearance assessment. Here 'n' signifies number of participants with available data for specified category.|Baseline, Week 12, 28, 40, 52, 80, 104, 132, 156, 184, 208, 236 and 260|Analysis was performed on FAS.|||Percent change||Standard Deviation|Mean
1471004|NCT00701415|Primary|Skin Globotriaosylceramide (GL-3) Clearance From Superficial Skin Capillary Endothelium|Skin biopsies were taken at Baseline, Week 52, Week 156 and Week 260 or early withdrawal and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was scored for GL-3 accumulation on a severity score-scale of none, mild, moderate, severe (0-1-2-3). Scores are categorized as normal (score = 0) or abnormal (score = 1, 2 or 3). Data was summarized in terms of number of participants with none/trace, mild, moderate and severe biopsy scores.|Baseline, Week 52, Week 156 and Week 260|Analysis was performed on Full analysis set (FAS), which included all randomized participants who received at least 1 infusion of study treatment.|||Percentage of participants|||Number
1471005|NCT00701389|Secondary|Number of Participants Who Were Discontinued From Any Study Period Due to an Adverse Event|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event. The number of participants who were discontinued from the study due to adverse event was summarized.|up to 10 weeks|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Participants|||Number
1471006|NCT00701389|Secondary|Number of Participants Who Experienced an Adverse Event During the Study|Participants were assessed throughout the study for adverse events. An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an adverse event.|up to 14 days after last dose of study drug (up to 10 weeks)|All Patients as Treated defined as all participants who received at least one dose of the investigational drug. Adverse events were reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Participants|||Number
1471007|NCT00701389|Secondary|Time-weighted Mean Arterial Pressure (Telcagepant Versus Placebo)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered telcagepant or placebo in either Periods 1, 2, 3, or 4 regardless of sequence.|||mmHg||95% Confidence Interval|Least Squares Mean
1471008|NCT00701389|Primary|Time-weighted Mean Arterial Pressure (Sumatriptan With Telcagepant Versus Sumatriptan Alone)|In each treatment period (1 through 4), duplicate readings of semi-recumbent blood pressure (BP) were completed using an automated blood pressure machine at predose, 30, 60, 90, 120, 150, 180, and 360 minutes postdose. Mean arterial pressure (MAP) was calculated as follows: MAP = Diastolic Blood Pressure (DBP) + (0.33 * Pulse Pressure [PP]) where PP = Systolic Blood Pressure [SBP] minus DBP. Only mean arterial pressure measurements up to and including 150 minutes postdose (including the predose measurement) were used to calculate the time-weighted averages. Time-weighted averages for each participant were obtained by calculating the area under the measurement-time curve of mean arterial pressure divided by the time period over which measurements were made (i.e. 150 minutes).|Predose up to 150 minutes postdose of each treatment period (up to 10 weeks)|Participants who were administered sumatriptan with telcagepant or sumatriptan alone in either Periods 1, 2, 3, or 4 regardless of sequence and had evaluable blood pressure data obtained.|||mmHg||95% Confidence Interval|Least Squares Mean
1471009|NCT00701363|Secondary|Subject Treatment Schedule Preference|"At week 24, the preference assessed between Octreotide Long Acting Repeatable intramuscular injection (Oct-LAR IM) every 4 weeks and Lanreotide Autogel 120 mg subcutaneous injection (SC) every 6 weeks.~At week 48, the preference is assessed between Oct-LAR IM every 4 weeks and Lanreotide Autogel 120 mg SC either injected every 4, 6 or 8 weeks (as injected during Phase II of the study)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Lan: Lanreotide~W: Week~Inj: Injection~Wks: Weeks~Phs: Phase~Grp: Group~evy: every"|||Percentage of subjects|||Number
1471010|NCT00701363|Secondary|Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL||At weeks 24 and 48|n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1471011|NCT00701363|Secondary|Serum Growth Hormone (GH) Levels||At Baseline, week 24 and week 48|"ITT population. n = Number of subjects at the visit.~Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2."|||ng/mL||Standard Deviation|Mean
1471012|NCT00701363|Secondary|Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit|"AcroQoL change from Baseline to Week 24 (48) = AcroQoL at Week 24 (48) - AcroQoL at Baseline.~IGF-1 change from Baseline to Week 24 (48) = IGF-1 at Week 24 (48) - IGF-1 at Baseline.~Correlation presented is a Spearman correlation (non parametric)."|At weeks 24 and 48|"ITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."|||Correlation coefficient||95% Confidence Interval|Number
1471013|NCT00701363|Secondary|Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48|The criterion for a subject is satisfied if he had a IGF-1 level (age and sex adjusted) without any worsening of the AcroQoL change score between Inclusion and Week 48.|At week 48 (End of Study)|"MITT population. n = Number of subjects at the visit.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included."|||Percentage of subjects||95% Confidence Interval|Number
1471014|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (SF-36)|Short Form-36 questionnaire (SF-36) score comprises eight components: Physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health on a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|ITT population. n = Number of subjects at the visit. Phase 1 only: These 15 subjects participated only in phase 1 and did not move on to phase 2.|||Units on a scale||Standard Deviation|Mean
1471015|NCT00701363|Secondary|Mean Changes From Baseline in Quality of Life Scores (AcroQoL)|AcroQoL score groups 22 components: Eight physical, Seven psychological appearance and Seven psychological personal relations, adjusted to a scale of 100, where a score of 100 corresponds to the best possible QoL and 0 to the worst.|At weeks 24 and 48|"ITT population n = Number of subjects at the visit. Phase 1 only: These subjects participated only in phase 1 & did not move onto phase 2.~Only subjects from countries having a validated translation of the AcroQoL questionnaire (The Netherlands, Denmark, Sweden, France, Greece, Poland, South Korea, Brazil, Russia, Norway and Romania) were included"|||Units on a scale||Standard Deviation|Mean
1471016|NCT00701363|Secondary|Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)|Acromegaly symptoms were assessed by the patients using the Patient Assessed Acromegaly Symptom Questionnaire (PASQ) scale ranging from 0 (No symptoms) to 8 (Severe, incapacitating symptoms).|At baseline, week 24 and week 48|"ITT population.~Number of Participants Analyzed:~Phase 1 in week 24: 3~Phase 2 (Group A) in week 24: 13~Phase 2 (Group B) in week 24: 69~Phase 2 (Group C) in week 24: 25~Phase 2 (Group A) in week 48: 13~Phase 2 (Group B) in week 48: 68~Phase 2 (Group C) in week 48: 26~NA = Not Applicable"|||Units on a scale||Standard Deviation|Mean
1471017|NCT00701363|Secondary|Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24||Baseline (visit 1)|"ITT population. n = Number of subjects at the visit.~These subjects entered in phase 2~One subject was not included in this analysis because IGF-1 was lower than 130% at week 24 but not in the second phase and one subject in group A had missing IGF-1 value at baseline."|||Percentage of ULN||95% Confidence Interval|Mean
1471018|NCT00701363|Secondary|Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C||Baseline (visit 1)|"MITT population.~One subject in Group A had missing IGF-1 value at baseline. One subject in Group B had missing IGF-1 value at week 48 and two subjects did not attend week 48 (early withdrawal). One subject in Group C had missing IGF-1 value at week 48."|||Percentage of ULN||95% Confidence Interval|Mean
1471019|NCT00701363|Secondary|Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval|IGF-1 change from Baseline to Week 48 = Mean IGF-1 level at Week 48 - Mean IGF-1 level at Baseline|Baseline (visit 1) and week 48|MITT population. One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.|||Percentage of ULN||Standard Deviation|Mean
1471020|NCT00701363|Secondary|Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels|The criterion for a subject is satisfied if he extended his injection interval to eight weeks during Phase 2 of the study, whilst maintaining normalised IGF-1 levels at Week 48.|At week 48|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1471021|NCT00701363|Secondary|Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks|The criterion for a subject is satisfied if he maintained an injection interval of six weeks or increasing his injection interval to eight weeks during Phase 2 of the study.|During phase 2 of the study (up to week 48)|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1471022|NCT00701363|Secondary|Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)|The criterion for a subject is satisfied if he has a normalised IGF-1 level (age and sex adjusted) at week 24.|At week 24|ITT population. n = Number of subjects at the visit.|||Percentage of subjects||95% Confidence Interval|Number
1471023|NCT00701363|Primary|Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)|A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)|At week 48 (End of Study)|"Intention to Treat (ITT) population: All patients having received ≥1 study drug dose. Modified ITT (MITT) population: All subjects in the ITT population for whom group allocation was performed (included in Phase 2).~n = Number of subjects at the visit"|||Percentage of subjects||95% Confidence Interval|Number
1471024|NCT00701311|Primary|Global Response Assessment|"The primary efficacy measure was a Global Response Assessment (GRA), a subject completed questionnaire that measures improvement in overall symptoms on a 7-point scale: Markedly Improved - 7, Moderately Improved - 6, Mildly Improved - 5, Same - 4, Mildly Worse - 3, Moderately Worse - 2, Markedly Worse - 1.~The primary outcome showing response to treatment was the number of subjects that were moderately or markedly improved on the GRA scale."|12 weeks||||participants|||Number
1471033|NCT00701103|Secondary|Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)|Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND <5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.|Up to 2 years|The population consisted of all evaluable participants who received >90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.|||Percentage of Participants|||Number
1471025|NCT00701129|Primary|Disability Index Assessed by the Pompe Pediatric Evaluation of Disability Inventory (Pompe PEDI) at End of Study|The Pompe PEDI is a disease specific version of the PEDI that was developed to assess functional capabilities and performance in children with Pompe disease from 2 months through adolescence. It consists of all items of the original PEDI (197 functional skill items in 3 domains: self-care; mobility; and social function) and additional items in the functional skills, mobility, and self-care domains to reflect clinically relevant functional skills for children with Pompe disease. Each domain consisted of 2 subdomains: functional skill performance and caregiver assistance scale. Norm-based scoring was developed for these additional items, and scoring algorithms for the PEDI have been adjusted to reflect additional normative data collected for the Pompe PEDI. Total score range for each domain (mean of subdomains) and subdomain ranges from 0 to 100, where higher score indicates high capability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patient analyzed = number of patients with end of study Pompe PEDI assessment and n = number of patients with end of study assessment of specified category.|||units on a scale||Full Range|Median
1471026|NCT00701129|Primary|Motor Development Status Assessed by Alberta Infantile Motor Scale (AIMS) at End of Study|"AIMS is a 58-item reliable and valid measure of motor development for infants at risk for motor delay. It assesses infant movement in 4 positions (subscales): prone (reciprocal crawling); supine (moving hands to feet); sitting (sitting with arm support); and standing (pulls to stand). For each subscale, items were scored as observed or not observed. Item in the observed range create a motor window. When scoring, subscale scores are calculated by giving the child credit (1 point) for observed items within the motor window in addition to being given credit (1 point) for all of the less mature items before motor window. AIMS total score was calculated by summing the scores for 58 items and ranged from 0 to 58, with higher score indicating more mature motor development. Score was then compared with age-equivalent peers from normative sample and equivalence level age (in months) is reported. End of study refers to the last post baseline observation during study period (up to Week 79)."|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study AIMS assessment.|||months||Full Range|Median
1471027|NCT00701129|Primary|Gross Motor Disability Assessed by Gross Motor Function Measure-88 (GMFM-88) at End of Study|GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item is scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension is expressed as a percentage of the maximum score for that dimension. Total score is obtained by adding the percentage scores for each dimension and dividing the sum by the total number of dimensions. Total score ranges from 0% to 100%, where higher scores indicate better motor functions. A total score of <7.5% demonstrates gross motor disability. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, numbers of patients analyzed = patients with end of study GMFM-88 assessment.|||percentage of maximum total score||Full Range|Median
1471028|NCT00701129|Primary|Number of Patients With Ventilator Use at End of Study|Number of patients who had ventilator support at end of study was reported. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1471029|NCT00701129|Primary|Number of Patients With Normal/Abnormal Left Ventricular Mass (LVM) Z-Score and LVM Index at End of Study|LVM Z-score and LVM index were assessed by ECHO. LVM Z-Score provides an indicator of degree of standard deviations from the mean in a normal distribution. Negative values indicate a smaller LVM than mean and values higher than 0 indicate a larger LVM than the mean. The normal range for LVM Z-Score is -2 to 2. Values <-2 or >2 indicate abnormal LVM Z-Score. LVM index is an index value derived by normalizing LVM by body surface area. LVM index provides evidence of cardiomyopathy. LVM index values <65 gram per meter^2 (g/m^2) were considered as normal and LVM index values >=65 g/m^2 were considered as abnormal. End of study refers to the last post baseline observation during study period (up to Week 79).|End of study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1471030|NCT00701129|Primary|Number of Patients Who Survived at End of Study||Baseline up to End of study (Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1471031|NCT00701129|Primary|Number of Patients With Recombinant Human Acid Alfa-glucosidase (rhGAA) Inhibitory Antibody at End of Study|Patients with positive anti-rhGAA IgG antibody were assessed for the presence of inhibitory antibodies (inhibition of enzyme activity and inhibition of enzyme uptake). Enzyme-linked immunosorbent assay (ELISA) was used to measure inhibition of rhGAA enzymatic activity in vitro and a cell-based assay was used to measure the inhibition of the uptake of rhGAA in normal fibroblast cells by flow cytometry.|End of study (up to Week 79)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa. Here, number of patients analyzed = patients with positive anti-rhGAA IgG antibody.|||participants|||Number
1471032|NCT00701129|Primary|Change From Baseline in Number of Patients With Anti-Recombinant Human Acid Alfa-glucosidase (Anti-rhGAA) Immunoglobulin G (IgG) Antibody at End of Study|Serum samples from patients were analyzed for the presence of anti-rhGAA IgG antibodies. End of study (EOS) refers to the last post baseline observation during study period (up to Week 79).|Baseline, End of Study (up to Week 79 or early termination)|FAS population included all enrolled patients who signed informed consent and received at least 1 dose of alglucosidase alfa.|||participants|||Number
1471043|NCT00701090|Secondary|Percent of Patients With A1C <7.0% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percentage of Participants|||Number
1471034|NCT00701103|Secondary|Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab|It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).|Up to 2 years|The population consisted of all participants who received >90% of intended drug volume and had measurements at Baseline and at least once during treatment.|||Percentage of Participants|||Number
1471035|NCT00701103|Secondary|Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples|IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had IGF-1R tumor pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 2.5 mg/kg Q1W and Dalotuzumab 30 mg/kg Q3W treatment groups.|||H-score||Standard Deviation|Mean
1471036|NCT00701103|Secondary|Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples|IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.|Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)|The population consisted of all evaluable participants who received >90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.|||H-score||Standard Deviation|Mean
1471037|NCT00701103|Primary|Mean Trough Serum Concentration (Ctrough) of Dalotuzumab|The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.|Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.|||ug/mL||Standard Deviation|Mean
1471038|NCT00701103|Primary|Mean Serum Clearance of Dalotuzumab|Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had mean serum clearance pharmacokinetic measurements at Baseline and at least once during treatment.|||mL/min/kg||Standard Deviation|Mean
1471039|NCT00701103|Primary|Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab|AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.|||mg*hr/mL||Standard Deviation|Mean
1471040|NCT00701103|Primary|Mean Terminal Half-life (t1/2) of Dalotuzumab|Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.|Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion|The population consisted of all evaluable participants who received >90% of intended drug volume and had t1/2 pharmacokinetic measurements at Baseline and at least once during treatment.|||Hours||Full Range|Mean
1471041|NCT00701103|Primary|Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)|Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.|Up to 3 weeks|The population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
1471042|NCT00701090|Secondary|Percent of Patients With A1C <6.5% at Week 30||Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percentage of Participants|||Number
1471046|NCT00701090|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30|Change from baseline at Week 30 was defined as Week 30 minus Week 0.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||mg/dL||95% Confidence Interval|Least Squares Mean
1471047|NCT00701090|Primary|Change From Baseline in HbA1c at Week 30|Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent.|Week 0 to Week 30|The per protocol population included all patients with a baseline value, a measurement at Week 30, and no major protocol violations (i.e., drug compliance <85%, use of prohibited medications, change of Metformin dose, incorrect double-blind study medication).|||Percent||95% Confidence Interval|Least Squares Mean
1471048|NCT00701064|Primary|Clinical Assessed PTSD Scale (CAPS-2) and Clinical Global Impression (CGI)|The CAPS-2 is administered by a trained clinician. It is designed to assess changes in PTSD severity over time, the scale ranges from 0-136. Higher levels indicate greater severity of PTSD.|Mean change from baseline to post-treatment (5-6 weeks later)|Separate analysis will be conducted to include drop-outs and exclusions. reported are end of study data|||change in units on scale||Standard Deviation|Mean
1471049|NCT00701051|Secondary|Body Composition (%Fat)||baseline, 24 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||percentage of fat||Standard Error|Mean
1471050|NCT00701051|Secondary|Cardiorespiratory Fitness|Maximal oxygen consumption|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||L/Min||Standard Error|Mean
1471051|NCT00701051|Primary|Skeletal Muscle Capillarization (Pre/Post Intervention)||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||capillaries/mm2||Standard Error|Mean
1471052|NCT00701051|Primary|Baseline Skeletal Muscle Capillarization||baseline||||capillaries/mm2||Standard Error|Mean
1471053|NCT00701051|Secondary|Baseline Cardiorespiratory Fitness|maximal oxygen consumption|baseline||||L/min||Standard Error|Mean
1471054|NCT00701051|Secondary|2-hr Post-prandial Plasma Glucose Level||baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||mg/dL||Standard Error|Mean
1471055|NCT00701051|Primary|Glucose Utilization (Pre/Post Intervention)|Insulin-stimulated glucose uptake|baseline, 24 weeks, 26 weeks|Glucose tolerance data were analyzed as a continuous variable (combining Arms) as opposed to categorical (i.e., within each Arm) due to the sample size of this pilot study; thus, data are reported for the entire group of participants.|||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
1471056|NCT00701051|Secondary|Baseline 2-hour Postprandial Glucose||baseline||||mg/dl||Standard Error|Mean
1471057|NCT00701051|Primary|Baseline Glucose Utilization|Insulin-stimulated glucose uptake|baseline||||µmol/kgFFM/pmol insulin/min||Standard Error|Mean
1471058|NCT00701038|Primary|Left Ventricular Ejection Fraction Improvement|Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.|baseline and again after three nights in hospital|ITT|||percent change||Standard Error|Mean
1471059|NCT00700999|Primary|Percent Change in Brain Response Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean percent change in brain response in the prefrontal cortex during an emotion reappraisal task in the treatment (paroxetine) group and in the Combat Exposed Control group. Target areas are analyzed from fMRI scans which were completed before participants receive treatment and again after participants received 12 weeks of treatment with paroxetine (20-40mg QD). Combat Exposed Control participants received an fMRI scan after signing initial consent and again 12 weeks later.|Baseline and 12 weeks|The number of participants analyzed is only 17 in each arm. The total number of participants in the Intervention group who completed fMRI scans pre-treatment and post treatment is only 19, in the Combat Exposed Control Group it is 18. Three of the participants scans were removed from data analysis due to the level of movement during the scan.|||percent change in BOLD signal||Standard Deviation|Mean
1471060|NCT00700973|Primary|Addiction Severity Index Legal Composite|Scores range from 0 to 1, with higher scores indicating more severe legal problems.|One year post-intervention||||units on a scale||Standard Deviation|Mean
1471061|NCT00700817|Secondary|Hypoglycaamic Episodes, Weeks 52-78|Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Week 52-78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||episodes|||Number
1471062|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
1471079|NCT00700817|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26|Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1471063|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-78|Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-78|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
1471064|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 23 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
1471065|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-52|Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-52|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
1471066|NCT00700817|Secondary|Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products. An outlier subject from the lira 1.8 mg+met group, who experienced 21 minor hypoglycaemic episodes was excluded from this analysis.|||episodes|||Number
1471067|NCT00700817|Secondary|Hypoglyceamic Episodes, Weeks 0-26|Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.|Weeks 0-26|The safety analysis set is all randomised subjects who had been exposed to at least one dose of the trial products.|||episodes|||Number
1471068|NCT00700817|Secondary|Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 52, Week 78|Extension 2 Patient Reported Outcome Analysis Set consisted of all subjects in the Extension 2 FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Deviation|Mean
1471069|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 52|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Error|Least Squares Mean
1471070|NCT00700817|Secondary|Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26|The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.|Week 0, Week 26|Patient Reported Outcome Analysis Set consisted of all subjects in the FAS, except subjects from countries Serbia, Slovakia and Slovenia|||scores on a scale||Standard Error|Least Squares Mean
1471071|NCT00700817|Secondary|Mean Change in Pulse From Week 52 to Week 78|Mean change in pulse from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||beats/minute||Standard Deviation|Mean
1471072|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 52|Calculated as an estimate of the mean change from baseline in pulse at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1471073|NCT00700817|Secondary|Mean Change From Baseline in Pulse at Week 26|Calculated as an estimate of the mean change from baseline in pulse at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||beats/minute||Standard Error|Least Squares Mean
1471074|NCT00700817|Secondary|Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78|Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmHg||Standard Deviation|Mean
1471075|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1471076|NCT00700817|Secondary|Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmHg||Standard Error|Least Squares Mean
1471080|NCT00700817|Secondary|Mean Change in Waist Circumference From Week 52 to Week 78|Mean change in Waist Circumference from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||kg||Standard Deviation|Mean
1471081|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 52|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||participants||Standard Error|Least Squares Mean
1471082|NCT00700817|Secondary|Mean Change From Baseline in Waist Circumference at Week 26.|Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm||Standard Error|Least Squares Mean
1471083|NCT00700817|Secondary|Mean Change in Waist to Hip Ratio From Week 52 to Week 78|Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||cm/cm||Standard Deviation|Mean
1471084|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 52|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm/cm||Standard Error|Least Squares Mean
1471085|NCT00700817|Secondary|Mean Change From Baseline in Waist to Hip Ratio at Week 26.|Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||cm/cm||Standard Error|Least Squares Mean
1471086|NCT00700817|Secondary|Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.|Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
1471087|NCT00700817|Secondary|Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pg/mL||Standard Error|Least Squares Mean
1471088|NCT00700817|Secondary|Mean Change From Baseline in Adiponectin at Week 26.|Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mcg/mL||Standard Error|Least Squares Mean
1471089|NCT00700817|Secondary|Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pmol/L||Standard Error|Least Squares Mean
1471090|NCT00700817|Secondary|Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.|Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||pg/mL||Standard Error|Least Squares Mean
1471091|NCT00700817|Secondary|Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.|Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||U/L||Standard Error|Least Squares Mean
1471092|NCT00700817|Secondary|Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26|Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mg/L||Standard Error|Least Squares Mean
1471093|NCT00700817|Secondary|Mean Change in Apolipoprotein B From Week 52 to Week 78|Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471094|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 52|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||g/L||Standard Error|Least Squares Mean
1471095|NCT00700817|Secondary|Mean Change From Baseline in Apolipoprotein B at Week 26|Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||g/L||Standard Error|Least Squares Mean
1471096|NCT00700817|Secondary|Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78|Mean change in free fatty acids (FFA) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471097|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471098|NCT00700817|Secondary|Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26|Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471099|NCT00700817|Secondary|Mean Change in Triglycerides (TG) From Week 52 to Week 78|Mean change in triglycerides (TG) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471100|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 52|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471101|NCT00700817|Secondary|Mean Change From Baseline in Triglycerides (TG) at Week 26|Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471102|NCT00700817|Secondary|Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78|Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471103|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471104|NCT00700817|Secondary|Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26|Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471105|NCT00700817|Secondary|Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78|Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471106|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471107|NCT00700817|Secondary|Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26|Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471108|NCT00700817|Secondary|Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78|Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471109|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471110|NCT00700817|Secondary|Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26|Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471111|NCT00700817|Secondary|Mean Change in Total Cholesterol From Week 52 to Week 78|Mean change in total cholesterol from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471112|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 52|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471113|NCT00700817|Secondary|Mean Change From Baseline in Total Cholesterol at Week 26|Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471256|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Stroma|CSF-1 levels were measured by immunohistochemistry (IHC).|Surgery||||Histo-score (H-Score)||Full Range|Median
1471114|NCT00700817|Secondary|Mean Change in Beta-cell Function From Week 52 to Week 78|Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage point||Standard Deviation|Mean
1471115|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 52|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
1471116|NCT00700817|Secondary|Mean Change From Baseline in Beta-cell Function at Week 26|"Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26.~Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B)."|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage point||Standard Error|Least Squares Mean
1471117|NCT00700817|Secondary|Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78|Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||mmol/L||Standard Deviation|Mean
1471118|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78|Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471119|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471120|NCT00700817|Secondary|Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||mmol/L||Standard Error|Least Squares Mean
1471121|NCT00700817|Secondary|Mean Change in Body Weight From Week 52 to Week 78|Mean change in body weight from Week 52 to Week 78.|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||kg||Standard Deviation|Mean
1471122|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 52|Calculated as an estimate of the mean change from baseline in body weight at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||kg||Standard Error|Least Squares Mean
1471123|NCT00700817|Secondary|Mean Change From Baseline in Body Weight at Week 26|Calculated as an estimate of the mean change from baseline in body weight at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||kg||Standard Error|Least Squares Mean
1471124|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage of subjects|||Number
1471125|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1471126|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1471127|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1471128|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.|Week 0, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||percentage of subjects|||Number
1471129|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1471130|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52|Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1471131|NCT00700817|Secondary|Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||percentage of subjects|||Number
1471132|NCT00700817|Primary|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78|Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78|Week 52, Week 78|Extension 2 FAS using LOCF (last observation carried forward) is all subjects in the FAS who completed 52 weeks of treatment and who were exposed in the last extension period (week 52 to week 78)|||Percentage point of total HbA1c||Standard Deviation|Mean
1471133|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.|Week 0, Week 78|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1471134|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.|Week 0, Week 52|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1471135|NCT00700817|Primary|Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26|Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, Week 26|FAS (full analysis set) using LOCF (last observation carried forward) is all randomised subjects who had been exposed to at least one dose of trial drug.|||Percentage point of total HbA1c||Standard Error|Least Squares Mean
1471136|NCT00700804|Primary|Calcium Absorption|Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time|17 weeks|Only participants which completed both protein diet periods were included in the statistical analysis|||percentage of Calcium absorbed||Standard Deviation|Mean
1471137|NCT00700804|Secondary|Serum Insulin-like Growth Factor 1 (IGF-1)||7 weeks||||nanomoles per liter (nmols/L)||Standard Error|Geometric Mean
1471138|NCT00700752|Primary|Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).|Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.|after 4 weeks of lens wear||||Units on a scale||Standard Error|Least Squares Mean
1471139|NCT00700739|Secondary|Device Related Adverse Events|The proportion of subjects with device related adverse events as reported throughout the duration of the study.|Intra-operatively to 24 months post-operative||||Percentage of subjects|||Number
1471140|NCT00700739|Secondary|Cervical Range of Motion Measured Radiographically at 6 Months|Cervical range of motion measures the angle, in degrees, between the inferior endplate of C2 to the inferior endplate of C7 on flexion-extension radiographs.|6 months|Only 2 subjects in the cTDR and 2 subjects in the ACDF treatment groups were available for this outcome measure.|||degrees||Standard Deviation|Mean
1471141|NCT00700739|Secondary|Foraminal Height Measured Radiographically at 24 Months|Foraminal height is the maximum vertical distance, measured in millimeters (mm), between the inferior surface of the superior pedicle and superior surface of the inferior pedicle. These measurements are obtained via magnetic resonance imaging (MRI).|24 months|The study was terminated prior to 24 months therefore there are no results for this endpoint.||||||
1471142|NCT00700739|Secondary|Maintenance of Disc Height Measured Radiographically at 6 Months|Maintenance of disc height is measured at the index and adjacent levels to determine the effect of the treatment on restoration or maintenance of the disc height. Initial post-operative disc height is compared with subsequent post-operative visits (i.e. 6 months) to evaluate the maintenance of disc height. The height is measured in millimeters (mm).|6 months|Only 2 subjects in the cTDR and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.|||mm||Standard Deviation|Mean
1471143|NCT00700739|Secondary|Adjacent Level Degeneration Measured Radiographically at 24 Months|Adjacent Level Degeneration is evaluated using a point system that assigns numerical scores to severity of Height Loss, Anterior Osteophytes, and Endplate Sclerosis; and then grades into one of the following five categories: None, Mild, Moderate, Severe, or NA.|24 months|Study was terminated prior to 24 months therefore there are no results for this endpoint.||||||
1471144|NCT00700739|Secondary|Sagittal Angulation, Also Known as Global Lordosis, Measured Radiographically at 6 Months|Sagittal Angulation is a measure of the angle formed between the inferior endplate of the C2 vertebrae and the corresponding inferior endplate of vertebrae C7 of the spine, measured in degrees, from a side (sagittal) view.|6 months|Only 2 subjects in the Cervical Total Disc Replacement (cTDR) and 1 subject in the ACDF treatment groups were available for this outcome measure. There were 2 ACDF subjects at this endpoint, however one subject was missing the flexion extension rotation radiographic view therefore could not be included in the analysis.|||degrees||Standard Deviation|Mean
1471145|NCT00700739|Secondary|Work Status Assessed at 12 Months|The proportion of subjects with unrestricted work status (compared to subjects not working or with restricted work status) is reported at the 12 month follow-up interval.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 12 subjects in the ACDF treatment groups were available for this outcome.|||Percentage of Subjects|||Number
1472266|NCT00690378|Secondary|Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit|Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL|End of IV therapy (4 to 14 days)||||Participants|||Number
1471146|NCT00700739|Secondary|Change in Function Assessed by Neck Disability Index Improvement From Pre-treatment to 12 Months|The neck disability index (NDI) is a validated, disease specific, self-administrated questionnaire for assessing pain intensity and function in patients with neck pain on a scale from 0 to 100. A lower score is a better result (i.e. less severe pain and/or better function). The proportion of patients with an improved score (lower) of 15 points or more was the analysis variable.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||Percentage of Subjects|||Number
1471147|NCT00700739|Secondary|Change in Physical Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1471148|NCT00700739|Secondary|Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 From Pre-treatment to 12 Months|The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-36) and Mental Component Score (MCS-36)|12 months|Due to withdrawals and incomplete or unavailable assessments, 16 subjects in the CTDR and 10 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1471149|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 17 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1471150|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Shoulder Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right shoulder.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1471151|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Right Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0= 0 cm) listed on the left and 'Very severe pain' (score of 100= 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their right arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1471152|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Left Arm Pain From Pre-treatment to 12 Months.|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their left arm.|12 Months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1471153|NCT00700739|Secondary|Change in Visual Analogue Scale (VAS) Neck Pain From Pre-treatment to 12 Months|The visual analogue scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 100 = 10 cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their neck.|12 months|Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for this outcome.|||units on a scale||Standard Deviation|Mean
1471154|NCT00700739|Primary|Overall Patient Success|Overall success was a composite endpoint determined by the following clinical outcome measures: 1. Neck Disability Index ≥ 15-point improvement from baseline to 12 months post-operative, 2. No new clinically significant permanent abnormalities in neurological function (i.e. motor strength, nerve root tension signs, sensory and reflex signs) from baseline to 12 months post-operative, 3. No subsequent secondary surgical interventions (SSI) at the index level, and 4. No device-related serious events (dSAE) from intra-operative through 12-months post-operative. Please note that these time periods were intended to be from baseline to 24 months post-operative, but since the study was terminated early the 12 month time periods were utilized.|12 months|Overall Patient Success is composed of several outcome measures, some of which require a valid pre-operative and 12-month post-operative score. Due to withdrawals and incomplete or unavailable assessments, 18 subjects in the CTDR and 11 subjects in the ACDF treatment groups were available for the Overall Patient Success calculation.|||Percentage of subjects|||Number
1471166|NCT00700570|Secondary|Time to Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Time to disease progression was defined as the time from first dose to time of disease progression. Participants without progression were censored at the time of last tumor assessment. Time to disease progression was estimated using Kaplan-Meier analysis and expressed in months.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of EOT)|ITT Population.|||months||95% Confidence Interval|Median
1471155|NCT00700713|Other Pre-specified|Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
1471156|NCT00700713|Other Pre-specified|Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
1471157|NCT00700713|Primary|Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®|Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.|Day 0 (pre-vaccination) and Day 30 post-vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
1471158|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 2|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
1471159|NCT00700635|Secondary|Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination|Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.|7 days post-vaccination 1|Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.|||Percentage of Participants|||Number
1471160|NCT00700635|Secondary|Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
1471161|NCT00700635|Secondary|Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1471162|NCT00700635|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)|30 days post-vaccination|Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.|||Percentage of Participants|||Number
1471163|NCT00700622|Primary|Change From Baseline in HbA1c to Week 16|Change from Baseline in glycosylated hemoglobin at Week 16|Baseline to Week 16|Intent to Treat with Available Data at Week 16|||percentage of total hemoglobin||Standard Error|Least Squares Mean
1471164|NCT00700570|Secondary|Percentage of Participants by Best Overall Tumor Response According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was to be confirmed at a minimum of 4 weeks after the first documented response. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, as well as no new target lesions. Disease progression or PD was defined as a ≥20% increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. Non-evaluability for tumor assessment was also documented when applicable. The percentage of participants with each level of response was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
1471165|NCT00700570|Secondary|Percentage of Participants With a Best Overall Tumor Response of Complete Response (CR) or PR According to RECIST Version 1.1|Objective tumor response was assessed using RECIST version 1.1. CR was defined as the disappearance of all target lesions, and PR was defined as a ≥30% decrease in the sum of longest diameters compared to Baseline. Response was confirmed at a minimum of 4 weeks after the first documented response. The percentage of participants with confirmed CR or PR was calculated as [number of participants meeting the respective criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, within 4 weeks of EOT, and at least 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
1471182|NCT00700401|Secondary|Percentage of Participants With Positive Predictive Value|Positive predictive value is defined as participants with RVR who did not achieve SVR.|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
1471167|NCT00700570|Secondary|Percentage of Participants With Disease Progression|Objective tumor response was assessed using RECIST version 1.1. Disease progression was defined as a ≥20 percent (%) increase in the sum of longest diameters of target lesions, taking as reference the smallest sum obtained at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 3 years (at Baseline, end of Cycle 5, time of surgery, and within 4 weeks of end of treatment [EOT])|ITT Population.|||percentage of participants|||Number
1471168|NCT00700570|Primary|Percentage of Participants With Conversion From Unresectable to Resectable Liver Metastases|Participants were assessed via microscopic and macroscopic examination for tumor resectability after completion of 5 cycles of neoadjuvant treatment. Unresectable participants exhibited any of the following criteria: greater than or equal to (≥) 4 liver metastases; location and/or distribution of metastatic disease within the liver considered unsuitable for resection with clear margins; liver involvement precluding resection, in the setting of adequate parenchymal volume for otherwise viable liver function in the immediate postoperative period; and inability to maintain adequate circulation for viable liver function. Participants who had not met any of the above criteria at the end of 5 cycles underwent surgical resection. The percentage of participants with conversion from initially unresectable to resectable liver metastases was calculated as [number of participants eligible for surgical resection divided by the number analyzed] multiplied by 100.|After 5 cycles of neoadjuvant treatment (10 weeks)|ITT Population.|||percentage of participants|||Number
1471169|NCT00700440|Secondary|1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival||5 year|||||||
1471170|NCT00700440|Primary|3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy|"The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.~Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria."|3 months||||participants with loco-regional control|||Number
1471171|NCT00700427|Secondary|Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49|The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with <0 interpreted as a health state “worse than dead.” A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1471172|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|BRIEF-A:Informant is a 75-item third-party observer’s view of the participants’ executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1471173|NCT00700427|Secondary|Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49|The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1471174|NCT00700427|Secondary|Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49|CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
1475302|NCT00666536|Secondary|Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12||Weeks 2, 4, 8 and 12|Intent to treat (ITT), Last observation carried forward (LOCF)|||Percentage of Patients|||Number
1471175|NCT00700427|Secondary|Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49|The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.|Baseline (Week 24), Week 49|Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1471176|NCT00700427|Secondary|Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49|The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.|Baseline (Week 24), Week 49|All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
1471177|NCT00700427|Secondary|Number of Days Until Relapse|"Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.~CAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants)."|Baseline (Week 24) up to Week 49|Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).|||days||Standard Deviation|Mean
1471178|NCT00700427|Primary|Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period|Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.|Baseline (Week 24) up to Week 49|Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).|||percentage of responders|||Number
1471179|NCT00700401|Secondary|Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48|Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.|Baseline, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.|||Percent change||Standard Error|Mean
1471180|NCT00700401|Secondary|Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48|Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.|At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug. Data of participants available at the assessment time point were included in the analysis. 'n' is number of participants analyzed at the specified weeks.|||Percent change||Standard Error|Mean
1471181|NCT00700401|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 48 weeks|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||participants|||Number
1471257|NCT00699907|Primary|Colony Stimulating Factor (CSF-1) Expression in Ovarian Epithelium|CSF-1 levels were measured by immunohistochemistry (IHC).|Surgery|The Overall Number of Participants Analyzed represents all participants with a modified Histo-score that could be evaluated|||Histo-score (H-Score)||Full Range|Median
1471184|NCT00700401|Secondary|Percentage of Participants With Virological Response at Week 24|Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).|At Week 24|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1471185|NCT00700401|Secondary|Percentage of Participants With Rapid Virological Response at Week 4|Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.|At Week 4|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1471186|NCT00700401|Primary|Percentage of Participants With Sustained Virological Response at Week 48|Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).|At Week 48|Intention-to-treat (ITT) population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
1471187|NCT00700375|Primary|Occurrence of Contrast-induced Nephropathy|The primary endpoint was the occurrence of contrast-induced nephropathy, defined as an increase >0.5 mg/dl or >25% in serum Cr concentration within 2 days of the procedure compared to the baseline level.|after procedure and 1,2-3day after procedure||||participants|||Number
1471188|NCT00700310|Secondary|Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)|Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.|Baseline (Pre-ra